,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32340075,Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy for the treatment of mild-to-moderate endometriosis: randomised controlled trial.,"OBJECTIVE


To compare electrodiathermy with helium thermal coagulation in laparoscopic treatment of mild-to-moderate endometriosis.
DESIGN


Parallel-group randomised controlled trial.
SETTING


A UK endometriosis centre.
POPULATION


Non-pregnant women aged 16-50 years with a clinical diagnosis of mild-to-moderate endometriosis.
METHODS


If mild or moderate endometriosis was confirmed at laparoscopy, women were randomised to laparoscopic treatment with electrodiathermy or helium thermal coagulator.
MAIN OUTCOME MEASURES


Cyclical pain and dyspareunia (rated on a 100-mm visual analogue scale, VAS), quality of life at baseline and at 6, 12 and 36 weeks following surgery, operative blood loss and surgical complications.
RESULTS


A total of 192 women were randomised. Of these, 155 (81%) completed the primary outcome point at 12 weeks. In an intention-to-treat analysis, VAS scores for cyclical pain were significantly lower in the electrodiathermy group compared with the helium group at 12 weeks (mean difference, 9.43 mm; 95% CI 0.46, 18.40 mm; P = 0.039) and across all time points (mean difference, 10.13 mm; 95% CI 3.48, 16.78 mm; P = 0.003). A significant difference in dyspareunia also favoured electrodiathermy at 12 weeks (mean difference, 11.66 mm; 95% CI 1.39, 21.93 mm; P = 0.026). These effects were smaller than the proposed minimum important difference of 18.00 mm, however. Differences in some aspects of quality of life favoured electrodiathermy. There was no significant difference in operative blood loss (fold-change with helium as reference, 1.43; 95% CI 0.96, 2.15; P = 0.081).
CONCLUSIONS


Although electrodiathermy was statistically superior to helium ablation in reducing cyclical pain and dyspareunia, these effects may be too small to be clinically significant.
TWEETABLE ABSTRACT


Helium coagulation is not superior to electrodiathermy in laparoscopic treatment of mild-to-moderate endometriosis.",2020,"A significant difference in dyspareunia also favoured electrodiathermy at 12 weeks (mean difference = 11.66mm; 95% CI 1.39, 21.93; p = 0.026).","['laparoscopic treatment of mild-to-moderate endometriosis', 'A UK endometriosis centre', '192 women were randomized', 'mild-to-moderate endometriosis', 'Non-pregnant women aged 16-50 with a clinical diagnosis of mild-to-moderate endometriosis']","['Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy', 'electrodiathermy', 'laparoscopic treatment with electrodiathermy or helium thermal coagulator']","['cyclical pain and dyspareunia', 'operative blood loss; surgical complications', 'Cyclical pain and dyspareunia (rated on 100mm visual analogue scales), and quality of life', 'dyspareunia', 'operative blood loss', 'VAS scores for cyclical pain']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0018880', 'cui_str': 'Helium'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",192.0,0.391918,"A significant difference in dyspareunia also favoured electrodiathermy at 12 weeks (mean difference = 11.66mm; 95% CI 1.39, 21.93; p = 0.026).","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Misra', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sim', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'El-Gizawy', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Watts', 'Affiliation': 'Research and Innovation, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jerreat', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Coia', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ritchie', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16279']
1,32340585,"Comparative study of observed actions, motor imagery and control therapeutic exercise on the conditioned pain modulation in the cervical spine: a randomized controlled trial.","Aim:  The aim of this study was to compare the effects of cervical exercise, motor imagery (MI) and action observation (AO) of cervical exercise actions on conditioned pain modulation and pressure pain thresholds. The second objective was to assess the effects of these interventions on cervical motor activity (ranges of motion and muscle endurance), attention, and the ability to generate motor images. Study design:  Single-blinded randomized controlled trial. Materials and methods:  Fifty-four healthy subjects were randomly assigned to each group. Response conditioned pain modulation, pressure pain threshold, were the main variables. The secondary outcome measures included, cervical range of motion, Neck flexor endurance test, mental movement representation associated and psychosocial variables. Results:  All groups showed significant differences in time factor for all evaluated variables ( p  < .01) except pressure pain threshold over the tibial region. The  post hoc  analysis revealed significant within-group differences in the AE and AO groups in conditioned pain modulation ( p  < .05), with medium effect size in time [AE ( d  -0.61); AO ( d  -0.74)]. Conclusion:  The results showed that within-group changes in conditioned pain modulation, cervical muscle endurance, and attention where founded only in the AE and AO groups. Variations in pain thresholds at pressure in the trapezium area were also obtained in the three groups. Changes in the ranges of flexion-extension and rotation movement were presented exclusively in the exercise group, and in the capacity to generate motor images only in the AO group. However, there was no difference in the pressure pain threshold over the tibial region.",2020,All groups showed significant differences in time factor for all evaluated variables ( p  < .01) except pressure pain threshold over the tibial region.,"['cervical spine', 'Materials and methods:  Fifty-four healthy subjects']","['cervical exercise, motor imagery (MI) and action observation (AO) of cervical exercise actions', 'observed actions, motor imagery and control therapeutic exercise']","['time factor', 'conditioned pain modulation, cervical muscle endurance, and attention', 'pressure pain', 'Response conditioned pain modulation, pressure pain threshold', 'conditioned pain modulation and pressure pain thresholds', 'cervical range of motion, Neck flexor endurance test, mental movement representation associated and psychosocial variables', 'medium effect size in time [AE', 'cervical motor activity (ranges of motion and muscle endurance), attention, and the ability to generate motor images', 'conditioned pain modulation', 'flexion-extension and rotation movement']","[{'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0040225', 'cui_str': 'Time Factors'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",54.0,0.0766365,All groups showed significant differences in time factor for all evaluated variables ( p  < .01) except pressure pain threshold over the tibial region.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Morales Tejera', 'Affiliation': 'Escuela Internacional de Doctorado, Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain.'}, {'ForeName': 'Josue', 'Initials': 'J', 'LastName': 'Fernandez-Carnero', 'Affiliation': 'La Paz Hospital Institute for Health Research, IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Suso-Martí', 'Affiliation': 'Motion in Brains Research Group, Institute of Neuroscience and Sciences of the Movement (INCIMOV), Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, España.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cano-de-la-Cuerda', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Rey Juan Carlos University, Madrid, Spain.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Lerín-Calvo', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, España.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Remón-Ramiro', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, España.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'La Touche', 'Affiliation': 'La Paz Hospital Institute for Health Research, IdiPAZ, Madrid, Spain.'}]",Somatosensory & motor research,['10.1080/08990220.2020.1756244']
2,32280084,N-terminal pro-brain natriuretic peptide used for screening hemodynamically significant patent ductus arteriosus in very low birth weight infants: How and when?,"BACKGROUND


N-terminal pro-B-type natriuretic peptide (NTproBNP) appears to be a useful tool for diagnosing hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants. However, a consensus for its application has not been reached.
OBJECTIVE


The present study aims to evaluate the role of NTproBNP in predicting hsPDA in preterm infants, and explore the optimal cutoff value and testing-time.
METHODS


A prospective blind study of 120 preterm infants with birth weights of < 1,500 g was conducted at the NICU of Peking University Shenzhen Hospital. Blood samples were successively collected on the first three days after birth for NTproBNP analysis. Echocardiographies were performed on day three of life to confirm the status of the ductus arteriosus. A receiver operating characteristic curve (ROC) analysis was performed to determine the ability of NTproBNP to recognize hsPDA.
RESULTS


NTproBNP was significantly higher in infants with hsPDA, than in infants in the control group, on both day two (P < 0.001) and day three (P < 0.001). On day two, a NTproBNP cutoff value of 3,689.0 pmol/L offered an optimal predictive value for hsPDA, while on day three, the optimal cut-off value for hsPDA was 2,331.5 pmol/L. The investigators proposes day three of life (48-72 hours) as the optimal testing time.
CONCLUSION


The NTproBNP biomarker during the early neonatal period can be a useful tool for screening and assessing hsPDA in premature infants, especially on day three of life.",2020,"RESULTS


NTproBNP was significantly higher in infants with hsPDA, than in infants in the control group, on both day two (P < 0.001) and day three (P < 0.001).","['120 preterm infants with birth weights of\u200a<\u200a1,500\u200ag was conducted at the NICU of Peking University Shenzhen Hospital', 'diagnosing hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants', 'preterm infants', 'very low birth weight infants']","['N-terminal pro-B-type natriuretic peptide (NTproBNP', 'NTproBNP']",[],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}]","[{'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]",[],120.0,0.0403442,"RESULTS


NTproBNP was significantly higher in infants with hsPDA, than in infants in the control group, on both day two (P < 0.001) and day three (P < 0.001).","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neonatology, Peking University Shenzhen Hospital, ShenZhen, Guangdong, China.'}, {'ForeName': 'Zhen-Li', 'Initials': 'ZL', 'LastName': 'Huang', 'Affiliation': 'Department of Ultrasonic Diagnosis, Peking University Shenzhen Hospital, ShenZhen, Guangdong, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Gong', 'Affiliation': 'Department of Ultrasonic Diagnosis, Peking University Shenzhen Hospital, ShenZhen, Guangdong, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, Peking University Shenzhen Hospital, ShenZhen, Guangdong, China.'}, {'ForeName': 'Shuang-Chuan', 'Initials': 'SC', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, Peking University Shenzhen Hospital, ShenZhen, Guangdong, China.'}, {'ForeName': 'Yu-Xin', 'Initials': 'YX', 'LastName': 'Zhou', 'Affiliation': 'Department of Neonatology, Peking University Shenzhen Hospital, ShenZhen, Guangdong, China.'}]",Clinical hemorheology and microcirculation,['10.3233/CH-190803']
3,32347779,"Re: Ejaculatory Hood Sparing versus Standard Laser Photoselective Vaporization of the Prostate: Sexual and Urodynamic Assessment through a Double Blinded, Randomized TrialA. E. Abolazm, A. S. El-Hefnawy, M. Laymon, A. B. Shehab-El-Din and A. M. Elshal  J Urol  2020;  203:  792-801.",,2020,,[],['Re: Ejaculatory Hood Sparing Versus Standard Laser Photoselective Vaporization'],[],[],"[{'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}]",[],,0.41547,,"[{'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Geriatric Urology, Xiangya Hospital of Central South University, Changsha, Hu Nan, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Geriatric Urology, Xiangya Hospital of Central South University, Changsha, Hu Nan, China.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Geriatric Urology, Xiangya Hospital of Central South University, Changsha, Hu Nan, China.'}]",The Journal of urology,['10.1097/JU.0000000000001093']
4,32347815,The Development and Evaluation of a Text Message Program to Prevent Perceived Insufficient Milk Among First-Time Mothers: Retrospective Analysis of a Randomized Controlled Trial.,"BACKGROUND


Several recent trials have examined the feasibility and efficacy of automated SMS text messaging to provide remote breastfeeding support to mothers, but these texting systems vary in terms of design features and outcomes examined.
OBJECTIVE


This study examined user engagement with and feedback on a theory-grounded SMS text messaging intervention intended to prevent perceived insufficient milk (PIM)-the single, leading modifiable cause of unintended breastfeeding reduction and cessation.
METHODS


We recruited 250 nulliparous individuals intending to breastfeed between 13 and 25 weeks of pregnancy in southwestern Pennsylvania. Participants were randomly assigned with equal allocation to either an SMS intervention to prevent PIM and unintended breastfeeding reduction or cessation (MILK, a Mobile, semiautomated text message-based Intervention to prevent perceived Low or insufficient milK supply; n=126) or a control group receiving general perinatal SMS text messaging-based support via the national, free Text4Baby system (n=124). Participants in both groups received SMS text messages 3 to 7 times per week from 25 weeks of pregnancy to 8 weeks postpartum. The MILK intervention incorporated several automated interactivity and personalization features (eg, keyword texting for more detailed information on topics and branched response logic) as well as an option to receive one-on-one assistance from an on-call study lactation consultant. We examined participant interactions with the MILK system, including response rates to SMS text messaging queries. We also sought participant feedback on MILK content, delivery preferences, and overall satisfaction with the system via interviews and a remote survey at 8 weeks postpartum.
RESULTS


Participants randomized to MILK (87/124, 70.2% white and 84/124, 67.7% college educated) reported that MILK texts increased their breastfeeding confidence and helped them persevere through breastfeeding problems. Of 124 participants, 9 (7.3%) elected to stop MILK messages, and 3 (2.4%) opted to reduce message frequency during the course of the study. There were 46 texts through the MILK system for individualized assistance from the study lactation consultant (25/46, 54% on weekends or after-hours). The most commonly texted keywords for more detailed information occurred during weeks 4 to 6 postpartum and addressed milk volume intake and breastfeeding and sleep patterns. MILK participants stated a preference for anticipatory guidance on potential breastfeeding issues and less content addressing the benefits of breastfeeding. Suggested improvements included extending messaging past 8 weeks, providing access to messaging for partners, and tailoring content based on participants' pre-existing breastfeeding knowledge and unique breastfeeding trajectory.
CONCLUSIONS


Prenatal and postpartum evidence-based breastfeeding support delivered via semiautomated SMS text messaging is a feasible and an acceptable intervention for first-time mothers. To optimize engagement with digital breastfeeding interventions, enhanced customization features should be considered.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02724969; https://clinicaltrials.gov/ct2/show/NCT02724969.",2020,"Participants were randomly assigned with equal allocation to either an SMS intervention to prevent PIM and unintended breastfeeding reduction or cessation (MILK, a Mobile, semiautomated text message-based Intervention to prevent perceived Low or insufficient milK supply; n=126) or a control group receiving general perinatal SMS text messaging-based support via the national, free Text4Baby system (n=124).","['Of 124 participants, 9 (7.3%) elected to stop MILK messages, and 3 (2.4%) opted to reduce message frequency during the course of the study', '250 nulliparous individuals intending to breastfeed between 13 and 25 weeks of pregnancy in southwestern Pennsylvania']","['MILK', 'automated SMS text messaging', 'MILK intervention', 'SMS text messages', 'SMS intervention to prevent PIM and unintended breastfeeding reduction or cessation (MILK, a Mobile, semiautomated text message-based Intervention to prevent perceived Low or insufficient milK supply; n=126) or a control group receiving general perinatal SMS text messaging-based support via the national, free Text4Baby system']","['MILK content, delivery preferences, and overall satisfaction', 'MILK texts increased their breastfeeding confidence and helped them persevere through breastfeeding problems']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C1283932', 'cui_str': 'Unintentional'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",250.0,0.113473,"Participants were randomly assigned with equal allocation to either an SMS intervention to prevent PIM and unintended breastfeeding reduction or cessation (MILK, a Mobile, semiautomated text message-based Intervention to prevent perceived Low or insufficient milK supply; n=126) or a control group receiving general perinatal SMS text messaging-based support via the national, free Text4Baby system (n=124).","[{'ForeName': 'Jill R', 'Initials': 'JR', 'LastName': 'Demirci', 'Affiliation': 'Department of Health Promotion & Development, University of Pittsburgh School of Nursing, Pittsburgh, PA, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Suffoletto', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Doman', 'Affiliation': 'Office of Academic Computing, Western Psychiatric Institute and Clinic, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Glasser', 'Affiliation': 'Department of Health Promotion & Development, University of Pittsburgh School of Nursing, Pittsburgh, PA, United States.'}, {'ForeName': 'Judy C', 'Initials': 'JC', 'LastName': 'Chang', 'Affiliation': 'Department of Obstetrics, Gynecology & Reproductive Sciences, and Internal Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'Department of Health & Community Systems, Center for Research and Evaluation, University of Pittsburgh School of Nursing, Pittsburgh, PA, United States.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Bogen', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.""}]",JMIR mHealth and uHealth,['10.2196/17328']
5,32352530,Association of Patient Demographic Characteristics and Insurance Status With Survival in Cancer Randomized Clinical Trials With Positive Findings.,"Importance


Few new treatments tested in phase 3 cancer randomized clinical trials show an overall survival benefit. Although understanding whether the benefits are consistent among all patient groups is critical for informing guideline care, individual trials are designed to assess the benefits of experimental treatments among all patients and are too small to reliably determine whether treatment benefits apply to demographic or insurance subgroups.
Objective


To systematically examine whether positive treatment effects in cancer randomized clinical trials apply to specific demographic or insurance subgroups.
Design, Setting, and Participants


Cohort study of pooled patient-level data from 10 804 patients in SWOG Cancer Research Network clinical treatment trials reported from 1985 onward with superior overall survival for those receiving experimental treatment. Patients were enrolled from 1984 to 2012. Maximum follow-up was 5 years.
Main Outcomes and Measures


Interaction tests were used to assess whether hazard ratios (HRs) for death comparing standard group vs experimental group treatments were associated with age (≥65 vs <65 years), race/ethnicity (minority vs nonminority populations), sex, or insurance status among patients younger than 65 years (Medicaid or no insurance vs private insurance) in multivariable Cox regression frailty models. Progression- or relapse-free survival was also examined. Data analyses were conducted from August 2019 to February 2020.
Results


In total, 19 trials including 10 804 patients were identified that reported superior overall survival for patients randomized to experimental treatment. Patients were predominantly younger than 65 years (67.3%) and female (66.3%); 11.4% were black patients, and 5.7% were Hispanic patients. There was evidence of added survival benefits associated with receipt of experimental therapy for all groups except for patients with Medicaid or no insurance (HR, 1.23; 95% CI, 0.97-1.56; P = .09) compared with those with private insurance (HR, 1.66; 95% CI, 1.44-1.92; P < .001; P = .03 for interaction). Receipt of experimental treatment was associated with reduced added overall survival benefits in patients 65 years or older (HR, 1.21; 95% CI, 1.11-1.32; P < .001) compared with patients younger than 65 years (HR, 1.41; 95% CI, 1.30-1.53; P < .001; P = .01 for interaction), although both older and younger patients appeared to strongly benefit from receipt of experimental treatment. The progression- or relapse-free survival HRs did not differ by age, sex, or race/ethnicity but differed between patients with Medicaid or no insurance (HR, 1.32; 95% CI, 1.06-1.64; P = .01) vs private insurance (HR, 1.74; 95% CI, 1.54-1.97; P < .001; P = .03 for interaction).
Conclusions and Relevance


Patients with Medicaid or no insurance may have smaller added benefits from experimental therapies compared with standard treatments in clinical trials. A better understanding of the quality of survivorship care that patients with suboptimal insurance receive, including supportive care and posttreatment care, could help establish how external factors may affect outcomes for these patients.",2020,"P = .01 for interaction), although both older and younger patients appeared to strongly benefit from receipt of experimental treatment.","['Patients were enrolled from 1984 to 2012', 'patients younger than 65 years (Medicaid or no insurance vs private insurance) in multivariable Cox regression frailty models', 'Data analyses were conducted from August 2019 to February 2020', 'Patients were predominantly younger than 65 years (67.3%) and female (66.3%); 11.4% were black patients, and 5.7% were Hispanic patients', 'patients with suboptimal insurance', 'Participants\n\n\nCohort study of pooled patient-level data from 10\u202f804 patients in SWOG Cancer Research Network clinical treatment trials reported from 1985 onward with superior overall survival for those receiving experimental treatment']",[],"['overall survival benefits', 'overall survival benefit', 'Patient Demographic Characteristics and Insurance Status', 'Progression- or relapse-free survival', 'added survival benefits', 'superior overall survival', 'progression- or relapse-free survival HRs', 'hazard ratios (HRs) for death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",10804.0,0.224841,"P = .01 for interaction), although both older and younger patients appeared to strongly benefit from receipt of experimental treatment.","[{'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Unger', 'Affiliation': 'SWOG Cancer Research Network Statistics and Data Management Center, Seattle, Washington.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Blanke', 'Affiliation': ""SWOG Cancer Research Network Group Chair's Office, Knight Cancer Institute, Oregon Health & Science University, Portland.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'LeBlanc', 'Affiliation': 'SWOG Cancer Research Network Statistics and Data Management Center, Seattle, Washington.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Barlow', 'Affiliation': 'SWOG Cancer Research Network Statistics and Data Management Center, Seattle, Washington.'}, {'ForeName': 'Riha', 'Initials': 'R', 'LastName': 'Vaidya', 'Affiliation': 'SWOG Cancer Research Network Statistics and Data Management Center, Seattle, Washington.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Ramsey', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Hershman', 'Affiliation': 'Columbia University Medical Center, New York, New York.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.3842']
6,31819201,Hypoxia and exercise interactions on skeletal muscle insulin sensitivity in obese subjects with metabolic syndrome: results of a randomized controlled trial.,"BACKGROUND


Physical activity improves insulin sensitivity in obesity. Hypoxia training is claimed to augment this effect. We tested the hypothesis that normobaric hypoxia training would improve insulin sensitivity in obese patients with metabolic syndrome.
METHODS


In a randomized controlled trial, 23 obese men with metabolic syndrome who were not informed of the FiO 2  conditions underwent a 6-week physical exercise intervention under ambient (n = 11; FiO 2  21%) conditions or hypoxia (n = 12; FiO 2  15%) using a normobaric hypoxic chamber. Three 60-min sessions of interval training were performed each week at 60% of individual V̇O 2max . Assessment of myocellular insulin sensitivity by euglycemic hyperinsulinemic clamp was performed in 21 of these subjects before and after 6 weeks of training. Comprehensive phenotyping also included biopsies of subcutaneous adipose tissues.
RESULTS


The intermittent moderate physical exercise protocol did not substantially change the myocellular insulin sensitivity within 6 weeks under normoxic conditions (ISI Clamp : 0.035 (IQR 0.016-0.075) vs. 0.037 (IQR 0.026-0.056) mg* kg -1  *min -1 /(mU* l -1 ); p = 0.767). In contrast, ISI Clamp  improved during hypoxia training (0.028 (IQR 0.018-0.035) vs. 0.038 (IQR 0.024-0.060) mg * kg -1  *min -1 /(mU *l -1 ); p < 0.05). Between group comparison of ISI Clamp  change revealed a small difference between groups (Cohen's d = 0.26). Within the hypoxic group, improvement of ISI Clamp  during training was associated with individual increase of circulating vascular endothelial growth factor (VEGF) levels (r = 0.678, p = 0.015), even if mean VEGF levels were not modified by any training condition. Atrial natriuretic peptide (ANP) system components were not associated with increased ISI Clamp  during hypoxic training.
CONCLUSIONS


Physical training under hypoxic conditions could partially augment the favorable effects of exercise alone on myocellular insulin sensitivity in obese men with metabolic syndrome. Concomitant changes in VEGF might represent an underlying pathophysiological mechanism.",2020,Between group comparison of ISI Clamp  change revealed a small difference between groups (Cohen's d = 0.26).,"['obese subjects with metabolic syndrome', 'obese men with metabolic syndrome', 'obese patients with metabolic syndrome', '23 obese men with metabolic syndrome who were not informed of the FiO 2  conditions underwent a']","['exercise alone', 'ISI Clamp', 'euglycemic hyperinsulinemic clamp', 'Hypoxia and exercise interactions', 'Hypoxia training', '6-week physical exercise intervention under ambient (n\u2009=\u200911; FiO 2  21%) conditions or hypoxia (n\u2009=\u200912; FiO 2  15%) using a normobaric hypoxic chamber', 'normobaric hypoxia training']","['ISI Clamp', 'circulating vascular endothelial growth factor (VEGF) levels', 'skeletal muscle insulin sensitivity', 'myocellular insulin sensitivity', 'insulin sensitivity', 'mean VEGF levels', 'ISI Clamp  improved during hypoxia training']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",23.0,0.0577071,Between group comparison of ISI Clamp  change revealed a small difference between groups (Cohen's d = 0.26).,"[{'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Mai', 'Affiliation': 'Experimental and Clinical Research Center (ECRC), a joint collaboration between the Max-Delbrück Center for Molecular Medicine and the Charité Universitätsmedizin, Berlin, Germany, and Helios Clinics Berlin, Berlin, Germany. knut.mai@charite.de.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Klug', 'Affiliation': 'Experimental and Clinical Research Center (ECRC), a joint collaboration between the Max-Delbrück Center for Molecular Medicine and the Charité Universitätsmedizin, Berlin, Germany, and Helios Clinics Berlin, Berlin, Germany.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Rakova', 'Affiliation': 'Experimental and Clinical Research Center (ECRC), a joint collaboration between the Max-Delbrück Center for Molecular Medicine and the Charité Universitätsmedizin, Berlin, Germany, and Helios Clinics Berlin, Berlin, Germany.'}, {'ForeName': 'Sophie K', 'Initials': 'SK', 'LastName': 'Piper', 'Affiliation': 'Berlin Institute of Health (BIH), Anna-Louisa-Karsch Str. 2, 10178, Berlin, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Mähler', 'Affiliation': 'Experimental and Clinical Research Center (ECRC), a joint collaboration between the Max-Delbrück Center for Molecular Medicine and the Charité Universitätsmedizin, Berlin, Germany, and Helios Clinics Berlin, Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bobbert', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Medical Clinic of Endocrinology, Diabetes & Nutrition, Berlin, Germany.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Schulz-Menger', 'Affiliation': 'Experimental and Clinical Research Center (ECRC), a joint collaboration between the Max-Delbrück Center for Molecular Medicine and the Charité Universitätsmedizin, Berlin, Germany, and Helios Clinics Berlin, Berlin, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Spranger', 'Affiliation': 'Experimental and Clinical Research Center (ECRC), a joint collaboration between the Max-Delbrück Center for Molecular Medicine and the Charité Universitätsmedizin, Berlin, Germany, and Helios Clinics Berlin, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boschmann', 'Affiliation': 'Experimental and Clinical Research Center (ECRC), a joint collaboration between the Max-Delbrück Center for Molecular Medicine and the Charité Universitätsmedizin, Berlin, Germany, and Helios Clinics Berlin, Berlin, Germany.'}, {'ForeName': 'Friedrich C', 'Initials': 'FC', 'LastName': 'Luft', 'Affiliation': 'Experimental and Clinical Research Center (ECRC), a joint collaboration between the Max-Delbrück Center for Molecular Medicine and the Charité Universitätsmedizin, Berlin, Germany, and Helios Clinics Berlin, Berlin, Germany.'}]",International journal of obesity (2005),['10.1038/s41366-019-0504-z']
7,32348985,Protocol and Baseline Data of a Multicentre Prospective Double-Blinded Randomized Study of Intravenous Iron on Functional Status in Patients with Chronic Kidney Disease.,"BACKGROUND


Iron deficiency (ID) is common in patients with chronic kidney disease (CKD) due to an inadequate dietary intake of iron, poor absorption from the gut and increased iron losses. In addition to preventing anaemia, iron is important for normal heart function, being involved in processes that generate a necessary continuous energy supply. Treatment with intravenous (IV) iron has been suggested to lead to improvement in heart function and well-being in people with ID and CKD. In the Iron and the Heart Study, we hypothesized that IV iron treatment will primarily improve exercise capacity and may secondarily impact the feeling of well-being in comparison to placebo over 3 months in non-anaemic CKD patients who have ID.
METHODS


This was a prospective double-blinded explorative randomized, multi-centre study designed to compare the effects of IV iron supplementation and placebo in iron-deficient but not anaemic patients with established CKD stages 3b-5 on functional status, and in addition cardiac structure and function. The study included 54 adults with serum ferritin (SF) <100 µg/L and/or transferrin saturation <20%, randomized in a 1:1 ratio to 1,000 mg IV ferric derisomaltose or placebo. Following randomization, participants underwent baseline assessments and then received IV iron or placebo infusion. Each participant was followed up at months 1 and 3. At each visit, patients underwent clinical review, measurements of hematinics and haemoglobin (Hb), and assessments of physical function and well-being. The primary outcome was exercise capacity using the 6-minute walk test. Secondary objectives included effects on hematinic profiles and Hb concentration, changes in myocardial parameters assessed with speckle tracking echocardiography and change in patients' quality of life.
RESULTS


Between October 2016 and April 2018, 55 from 326 individuals from 3 UK centres attended screening and were randomized. The mean (SD) age was 59.6 (11.7) years, 26 (48%) patients were male, the majority were Caucasians (42; 78%), and 32 (59%) were non-smokers. The mean (SD) body mass index was 30.3 (6.5); SF was 66.3 (44.1) µg/L, TS was 20.1 (7.4) % and Hb was 128.7 (10.1) g/L at randomization for the whole group. Mean (SD) serum creatinine was 186.7 (58.6) µmol/L, estimated glomerular filtration rate was 31.1 (9.6) mL/min/1.73 m2 and urinary albumin and protein/creatinine ratios 60.9 (133.3) and 83.8 (128.4) mg/mmol respectively. The mean (SD) C-reactive protein was 5.0 (4.4) mg/L and the mean (SD) 6-minute walk distance at baseline was 401.2 (120.2) m.
CONCLUSION


The Iron and the Heart Trial will provide important information on the short-term effects of IV iron treatment in CKD patients with ID without anaemia on measures of exercise capacity, quality of life and mechanistic data on myocardial structure and function.
TRIAL REGISTRATION


European Clinical Trials Database (No. 2014-004133-6; REC no. 14/YH/1209; Sponsor ref. R1766).",2020,Treatment with intravenous (IV) iron has been suggested to lead to improvement in heart function and well-being in people with ID and CKD.,"['54 adults with serum ferritin (SF', 'non-anaemic CKD patients who have ID', 'patients with chronic kidney disease (CKD', 'The mean (SD) age was 59.6 (11.7) years, 26 (48', 'CKD patients with ID without anaemia', 'anaemic patients with established CKD stages 3b-5 on functional status, and in addition cardiac structure and function', 'Patients with Chronic Kidney Disease', 'Between October 2016 and April 2018, 55 from 326 individuals from 3 UK centres attended screening and were randomized', 'patients were male, the majority were Caucasians (42; 78%), and 32 (59%) were non-smokers']","['IV iron or placebo infusion', 'Intravenous Iron', 'intravenous (IV) iron', 'IV iron supplementation and placebo', 'placebo']","['exercise capacity using the 6-minute walk test', 'urinary albumin and protein/creatinine', 'exercise capacity', 'mean (SD) C-reactive protein', ""hematinic profiles and Hb concentration, changes in myocardial parameters assessed with speckle tracking echocardiography and change in patients' quality of life"", 'mean (SD) body mass index', 'glomerular filtration rate', 'Mean (SD) serum creatinine', 'mean (SD) 6-minute walk distance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517535', 'cui_str': '11.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0340950', 'cui_str': 'Iron deficiency without anemia'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C3839870', 'cui_str': 'Chronic kidney disease stage 3B'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0428627', 'cui_str': 'Protein/creatinine ratio measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0018928', 'cui_str': 'Hematinic'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",54.0,0.517268,Treatment with intravenous (IV) iron has been suggested to lead to improvement in heart function and well-being in people with ID and CKD.,"[{'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Bhandari', 'Affiliation': 'Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom, Sunil.Bhandari@hey.nhs.uk.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Allgar', 'Affiliation': 'University of York, York, United Kingdom.'}, {'ForeName': 'Archie', 'Initials': 'A', 'LastName': 'Lamplugh', 'Affiliation': 'Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom.'}, {'ForeName': 'Iain C', 'Initials': 'IC', 'LastName': 'Macdougall', 'Affiliation': ""King's College Hospital, London, United Kingdom.""}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Kalra', 'Affiliation': 'Salford Royal NHS Foundation Trust, Salford, United Kingdom.'}]",American journal of nephrology,['10.1159/000507872']
8,32343890,Olaparib for Metastatic Castration-Resistant Prostate Cancer.,"BACKGROUND


Multiple loss-of-function alterations in genes that are involved in DNA repair, including homologous recombination repair, are associated with response to poly(adenosine diphosphate-ribose) polymerase (PARP) inhibition in patients with prostate and other cancers.
METHODS


We conducted a randomized, open-label, phase 3 trial evaluating the PARP inhibitor olaparib in men with metastatic castration-resistant prostate cancer who had disease progression while receiving a new hormonal agent (e.g., enzalutamide or abiraterone). All the men had a qualifying alteration in prespecified genes with a direct or indirect role in homologous recombination repair. Cohort A (245 patients) had at least one alteration in  BRCA1 ,  BRCA2 , or  ATM ; cohort B (142 patients) had alterations in any of 12 other prespecified genes, prospectively and centrally determined from tumor tissue. Patients were randomly assigned (in a 2:1 ratio) to receive olaparib or the physician's choice of enzalutamide or abiraterone (control). The primary end point was imaging-based progression-free survival in cohort A according to blinded independent central review.
RESULTS


In cohort A, imaging-based progression-free survival was significantly longer in the olaparib group than in the control group (median, 7.4 months vs. 3.6 months; hazard ratio for progression or death, 0.34; 95% confidence interval, 0.25 to 0.47; P<0.001); a significant benefit was also observed with respect to the confirmed objective response rate and the time to pain progression. The median overall survival in cohort A was 18.5 months in the olaparib group and 15.1 months in the control group; 81% of the patients in the control group who had progression crossed over to receive olaparib. A significant benefit for olaparib was also seen for imaging-based progression-free survival in the overall population (cohorts A and B). Anemia and nausea were the main toxic effects in patients who received olaparib.
CONCLUSIONS


In men with metastatic castration-resistant prostate cancer who had disease progression while receiving enzalutamide or abiraterone and who had alterations in genes with a role in homologous recombination repair, olaparib was associated with longer progression-free survival and better measures of response and patient-reported end points than either enzalutamide or abiraterone. (Funded by AstraZeneca and Merck Sharp & Dohme; PROfound ClinicalTrials.gov number, NCT02987543.).",2020,All the men had a qualifying alteration in prespecified genes with a direct or indirect role in homologous recombination repair.,"['Cohort A (245 patients) had at least one alteration in  BRCA1 ,  BRCA2 , or  ATM ; cohort B (142 patients) had alterations in any of 12 other prespecified genes, prospectively and centrally determined from tumor tissue', 'men with metastatic castration-resistant prostate cancer who had disease progression while receiving a new hormonal agent (e.g., enzalutamide or abiraterone', 'patients with prostate and other cancers', 'men with metastatic castration-resistant prostate cancer who had disease progression while receiving', 'Metastatic Castration-Resistant Prostate Cancer']","['PARP inhibitor olaparib', 'enzalutamide or abiraterone', ""olaparib or the physician's choice of enzalutamide or abiraterone (control"", 'Olaparib']","['objective response rate and the time to pain progression', 'Anemia and nausea', 'median overall survival', 'imaging-based progression-free survival']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C2973986', 'cui_str': 'BRCA2 protein, human'}, {'cui': 'C0103097', 'cui_str': 'ammonium tetrathiomolybdate'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",245.0,0.264475,All the men had a qualifying alteration in prespecified genes with a direct or indirect role in homologous recombination repair.,"[{'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'de Bono', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Mateo', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Shore', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sartor', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Olmos', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Thiery-Vuillemin', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Przemyslaw', 'Initials': 'P', 'LastName': 'Twardowski', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Niven', 'Initials': 'N', 'LastName': 'Mehra', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Goessl', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Burgents', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kohlmann', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Carrie A', 'Initials': 'CA', 'LastName': 'Adelman', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}]",The New England journal of medicine,['10.1056/NEJMoa1911440']
9,32343967,Peak Inspiratory Flows: Defining Repeatability Limits and a Predictive Equation for Different Inhalers.,"BACKGROUND


Peak inspiratory flow (PIF) has been proposed as a measure to assess a patient's ability to use dry powder inhalers (DPIs). However, robust quality criteria to determine a repeatability limit for measuring PIF are lacking.
RESEARCH QUESTIONS


What are the repeatability limits for measuring PIF? What is the relationship between PIF measured using the In-Check DIAL device at Diskus (GlaxoSmithKline; PIF D ) and HandiHaler (Boehringer Ingelheim; PIF HH ) resistances?
STUDY DESIGN AND METHODS


Data from a randomized, controlled, phase 3 trial (study 0149; see Clinical Trial Registration data) were used to define repeatability limits for PIF. In addition, a model to characterize the relationship between PIF measured with the In-Check DIAL device at PIF D  and PIF HH  was defined using data from two randomized, controlled, phase 3 trials (studies 0128 and 0149).
RESULTS


In study 0128, the mean values (SD) for PIF at zero resistance and PIF HH  were 84.6 (33.4) and 57.3 (26.1) L/min, respectively. In study 0149, the mean values (SD) for PIF D  and PIF HH  were 42.4 (11.2) and 29.0 (8.3) L/min, respectively. At the mean level, the mean difference between measurement attempts for PIF D  and PIF HH  was small, < 5 and < 3 L/min, respectively. The repeatability limit was determined as 10 and 5 L/min for PIF D  and PIF HH , respectively. Modeling the relationship between PIF D  and PIF HH , after controlling for significant covariates, demonstrated that a PIF D  value of 60 L/min was approximately equivalent to PIF HH  of 40 L/min.
INTERPRETATIONS


This analysis demonstrated that the two highest values of PIF using the In-Check DIAL device among three inspiratory efforts, met the repeatability limit. Altogether, these data provide guidance for measuring PIF against the simulated resistance of a specific DPI in clinical practice and research studies.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov; Nos.: NCT02518139 (study 0128) and NCT03095456 (study 0149); URL: www.clinicaltrials.gov.",2020,"At the mean level, the mean difference between measurement attempts for PIF D  and PIF HH  was small, < 5 L/min and < 3 L/min, respectively.",[],['Peak inspiratory flow (PIF'],"['repeatability limit', 'mean values (standard deviation [SD]) for PIF at zero resistance and PIF HH', 'mean values (SD) for PIF D  and PIF HH', 'PIF D  and PIF HH']",[],"[{'cui': 'C0429742', 'cui_str': 'Peak inspiratory flow rate'}]","[{'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0429742', 'cui_str': 'Peak inspiratory flow rate'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",,0.0420994,"At the mean level, the mean difference between measurement attempts for PIF D  and PIF HH  was small, < 5 L/min and < 3 L/min, respectively.","[{'ForeName': 'Chris N', 'Initials': 'CN', 'LastName': 'Barnes', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Mahler', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Ohar', 'Affiliation': 'Wake Forest University Medical Center, Winston-Salem, NC.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lombardi', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA.'}, {'ForeName': 'Glenn D', 'Initials': 'GD', 'LastName': 'Crater', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA. Electronic address: gcrater@theravance.com.'}]",Chest,['10.1016/j.chest.2020.03.072']
10,32344891,Patient-Reported Outcome Measures (PROMs) for Two Implant Placement Techniques in Sinus Region (Bone Graft versus Computer-Aided Implant Surgery): A Randomized Prospective Trial.,"PURPOSE


To assess patient-reported outcomes measures (PROMs) for two implant placement techniques in cases of sinus bone atrophy (bone graft surgery (BGS) versus computer-aided implant surgery (CAIS)), after surgery and one year later, and to evaluate the clinical success of both treatments.
METHODS


Sixty patients with bone atrophy in the posterior maxilla and in need of implant placement were randomly assigned to two groups, and in accordance with the case report form (CRF), 30 were treated with BGS and 30 with CAIS. Immediately after treatment and one year later, PROMs were assessed, and the clinical success of both treatments was evaluated.
RESULTS


No significant differences were found between BGS and CAIS with regard to the following: loss of implants ( p  = 492); patient recommendation ( p  = 210); duration of surgery ( p  = 987); pain on the intervention day ( p  = 512); pain in the week after intervention ( p  = 299); and complications in the stage of surgery ( p  = 1.00). Similarly, at one year, no differences were found with regard to the following: pain around implant ( p  = 481); infection of implants ( p  = 491); abnormal radiographic imaging ( p  = 226); occurrence of undesirable events ( p  = 1.00); loss of one of the implants ( p  = 1.00); plaque detection ( p  = 1.00); bleeding on probing ( p  = 236); and presence of keratinized mucosa ( p  = 226). However, a significant difference was found among BGS and CAIS with regard to the number of consultations ( p  = 0001); number of implants placed ( p  = 033); and treatment difficulty ( p  = 0369). Significant differences were found for peri-implantitis ( p  = 0481) and radiology of craterization ( p  = 020) in clinical examination at the first year.
CONCLUSION


Treatment difficulty and number of consultations were higher for BGS than for CAIS, as well as peri-implantitis and bone craterization at one year, indicating significant differences between the two treatments. However, there were no statistically significant differences between BGS and CAIS regarding the other PROMs, at placement and after one year.",2020,"Significant differences were found for peri-implantitis ( p  = 0481) and radiology of craterization ( p  = 020) in clinical examination at the first year.
",['Sixty patients with bone atrophy in the posterior maxilla and in need of implant placement'],"['sinus bone atrophy (bone graft surgery (BGS) versus computer-aided implant surgery (CAIS', 'BGS and 30 with CAIS']","['BGS and CAIS', 'plaque detection', 'abnormal radiographic imaging', 'occurrence of undesirable events', 'peri-implantitis and bone craterization', 'pain around implant', 'pain', 'peri-implantitis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1389037', 'cui_str': 'Bone atrophy'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C1389037', 'cui_str': 'Bone atrophy'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0064494', 'cui_str': 'carboxyamido-triazole'}, {'cui': 'C0265308', 'cui_str': 'Baller-Gerold syndrome'}]","[{'cui': 'C0265308', 'cui_str': 'Baller-Gerold syndrome'}, {'cui': 'C0064494', 'cui_str': 'carboxyamido-triazole'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0457276', 'cui_str': 'Radiographic imaging - action'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]",60.0,0.0360508,"Significant differences were found for peri-implantitis ( p  = 0481) and radiology of craterization ( p  = 020) in clinical examination at the first year.
","[{'ForeName': 'Ghazwan', 'Initials': 'G', 'LastName': 'Almahrous', 'Affiliation': 'Department of Oral Surgery, Dental School, University Claude Bernard, 69003 Lyon, France.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'David-Tchouda', 'Affiliation': 'ThEMAS TIMC UMR CNRS 5525, Grenoble Joseph Fourier University, 38041 Grenoble, France.'}, {'ForeName': 'Aboubacar', 'Initials': 'A', 'LastName': 'Sissoko', 'Affiliation': 'Cellule Data Stat, University Hospital of Grenoble, 38700 Grenoble, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Rancon', 'Affiliation': 'Department of Oral Surgery, Hospices Civils, 69003 Lyon, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Bosson', 'Affiliation': 'ThEMAS TIMC UMR CNRS 5525, Grenoble Joseph Fourier University, 38041 Grenoble, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fortin', 'Affiliation': 'Department of Oral Surgery, Dental School, University Claude Bernard, 69003 Lyon, France.'}]",International journal of environmental research and public health,['10.3390/ijerph17092990']
11,32353418,Fluid Response Evaluation in Sepsis Hypotension and Shock: A Randomized Clinical Trial.,"BACKGROUND


Fluid and vasopressor management in septic shock remains controversial. In this randomized controlled trial, we evaluated the efficacy of dynamic measures (stroke volume change during passive leg raise) to guide resuscitation and improve patient outcome.
RESEARCH QUESTION


Will resuscitation that is guided by dynamic assessments of fluid responsiveness in patients with septic shock improve patient outcomes?
STUDY DESIGN AND METHODS


We conducted a prospective, multicenter, randomized clinical trial at 13 hospitals in the United States and United Kingdom. Patients presented to EDs with sepsis that was associated hypotension and anticipated ICU admission. Intervention arm patients were assessed for fluid responsiveness before clinically driven fluid bolus or increase in vasopressors occurred. The protocol included reassessment and therapy as indicated by the passive leg raise result. The control arm received usual care. The primary clinical outcome was positive fluid balance at 72 hours or ICU discharge, whichever occurred first.
RESULTS


In modified intent-to-treat analysis that included 83 intervention and 41 usual care eligible patients, fluid balance at 72 hours or ICU discharge was significantly lower (-1.37 L favoring the intervention arm; 0.65 ± 2.85 L intervention arm vs 2.02 ± 3.44 L usual care arm; P = .021. Fewer patients required renal replacement therapy (5.1% vs 17.5%; P = .04) or mechanical ventilation (17.7% vs 34.1%; P = .04) in the intervention arm compared with usual care. In the all-randomized intent-to-treat population (102 intervention, 48 usual care), there were no significant differences in safety signals.
INTERPRETATION


Physiologically informed fluid and vasopressor resuscitation with the use of the passive leg raise-induced stroke volume change to guide management of septic shock is safe and demonstrated lower net fluid balance and reductions in the risk of renal and respiratory failure. Dynamic assessments to guide fluid administration may improve outcomes for patients with septic shock compared with usual care.
CLINICAL TRIAL REGISTRATION


NCT02837731.",2020,"Fewer patients required renal replacement therapy (5.1% vs 17.5%, p=0.04) or mechanical ventilation (17.7% vs 34.1%, p=0.04) in the Intervention arm compared to Usual Care.","['Sepsis Hypotension and Shock', 'septic shock patients', 'patients with septic shock', '13 hospitals in the United States and United Kingdom', 'Patients presented to Emergency Rooms with sepsis associated hypotension and anticipated Intensive Care Unit (ICU) admission']","['Usual Care', 'Fluid Response Evaluation']","['renal replacement therapy', 'fluid responsiveness', 'mechanical ventilation', 'safety signals', 'positive fluid balance at 72 hours or ICU discharge, whichever occurred first']","[{'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C2364300', 'cui_str': 'Positive fluid balance'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]",,0.241826,"Fewer patients required renal replacement therapy (5.1% vs 17.5%, p=0.04) or mechanical ventilation (17.7% vs 34.1%, p=0.04) in the Intervention arm compared to Usual Care.","[{'ForeName': 'Ivor S', 'Initials': 'IS', 'LastName': 'Douglas', 'Affiliation': 'Pulmonary Science and Critical Care Medicine, Denver Health Medical Center and University of Colorado, Anschutz Medical Campus, Denver, CO. Electronic address: ivor.douglas@dhha.org.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Alapat', 'Affiliation': 'Pulmonary, Critical Care and Sleep Medicine, Ben Taub Hospital, Houston, TX.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Corl', 'Affiliation': 'Pulmonary, Critical Care and Sleep Medicine, Rhode Island Hospital, Providence, RI.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Exline', 'Affiliation': 'Pulmonary, Critical Care and Sleep Medicine, Ohio State University Hospital, Columbus, OH.'}, {'ForeName': 'Lui G', 'Initials': 'LG', 'LastName': 'Forni', 'Affiliation': 'Intensive Care Medicine and Nephrology, University of Surrey & Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Andre L', 'Initials': 'AL', 'LastName': 'Holder', 'Affiliation': 'Pulmonary, Allergy, Critical Care and Sleep Medicine, Emory University, Atlanta, GA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kaufman', 'Affiliation': 'NYU School of Medicine, New York, NY; Pulmonary and Critical Care Medicine, Bridgeport Hospital, Bridgeport, CT.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Pulmonary and Critical Care Medicine, Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Mitchell M', 'Initials': 'MM', 'LastName': 'Levy', 'Affiliation': 'Pulmonary, Critical Care and Sleep Medicine, Rhode Island Hospital, Providence, RI.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Martin', 'Affiliation': 'Pulmonary, Allergy, Critical Care and Sleep Medicine, Emory University, Atlanta, GA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Sahatjian', 'Affiliation': 'Cheetah Medical, Wilmington, DE.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Seeley', 'Affiliation': 'Pulmonary, Critical Care Medicine and Allergy, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Jeremy A', 'Initials': 'JA', 'LastName': 'Weingarten', 'Affiliation': 'Pulmonary, Critical Care and Sleep Medicine, New York-Presbyterian Brooklyn Methodist Hospital, Brooklyn, NY.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Pulmonary and Critical Care Medicine, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Hansell', 'Affiliation': 'Cheetah Medical, Wilmington, DE; Department of Anesthesiology, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, MA.'}]",Chest,['10.1016/j.chest.2020.04.025']
12,32349977,Bioimpedance Guided Fluid Management in Peritoneal Dialysis: A Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVES


Bioelectrical impedance analysis (BIA) devices can help assess volume overload in patients receiving maintenance peritoneal dialysis. However, the effects of BIA on the short-term hard end points of peritoneal dialysis lack consistency. This study aimed to test whether BIA-guided fluid management could improve short-term outcomes in patients on peritoneal dialysis.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


A single-center, open-labeled, randomized, controlled trial was conducted. Patients on prevalent peritoneal dialysis with volume overload were recruited from July 1, 2013 to March 30, 2014 and followed for 1 year in the initial protocol. All participants with volume overload were 1:1 randomized to the BIA-guided arm (BIA and traditional clinical methods) and control arm (only traditional clinical methods). The primary end point was all-cause mortality and secondary end points were cardiovascular disease mortality and technique survival.
RESULTS


A total of 240 patients (mean age, 49 years; men, 51%; diabetic, 21%, 120 per group) were enrolled. After 1-year follow-up, 11(5%) patients died (three in BIA versus eight in control) and 21 patients were permanently transferred to hemodialysis (eight in BIA versus 13 in control). The rate of extracellular water/total body water decline in the BIA group was significantly higher than that in the control group. The 1-year patient survival rates were 96% and 92% in BIA and control groups, respectively. No significant statistical differences were found between patients randomized to the BIA-guided or control arm in terms of patient survival, cardiovascular disease mortality, and technique survival ( P >0.05).
CONCLUSIONS


Although BIA-guided fluid management improved the fluid overload status better than the traditional clinical method, no significant effect was found on 1-year patient survival and technique survival in patients on peritoneal dialysis.",2020,"No significant statistical differences were found between patients randomized to the BIA-guided or control arm in terms of patient survival, cardiovascular disease mortality, and technique survival ( P >0.05).
","['patients on peritoneal dialysis', 'Peritoneal Dialysis', 'patients receiving maintenance peritoneal dialysis', '240 patients (mean age, 49 years; men, 51%; diabetic, 21%, 120 per group) were enrolled', 'Patients on prevalent peritoneal dialysis with volume overload were recruited from July 1, 2013 to March 30, 2014 and followed for 1 year in the initial protocol', 'All participants with volume overload']","['BIA-guided fluid management', 'Bioimpedance Guided Fluid Management', 'BIA-guided arm (BIA and traditional clinical methods) and control arm (only traditional clinical methods']","['patient survival, cardiovascular disease mortality, and technique survival', '1-year patient survival and technique survival', 'rate of extracellular water/total body water decline', 'cardiovascular disease mortality and technique survival', 'cause mortality', '1-year patient survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0553741', 'cui_str': 'Fluid balance regulation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",240.0,0.0676254,"No significant statistical differences were found between patients randomized to the BIA-guided or control arm in terms of patient survival, cardiovascular disease mortality, and technique survival ( P >0.05).
","[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Tian', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Qunying', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Medical Statistics, Clinical Trials Unit, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China yuxq@mail.sysu.edu.cn.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Yi', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jianxiong', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Peiyi', 'Initials': 'P', 'LastName': 'Cao', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hongjian', 'Initials': 'H', 'LastName': 'Ye', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Menghua', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China.'}, {'ForeName': 'Xueqing', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China yuxq@mail.sysu.edu.cn.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.06480619']
13,32357128,The Clinical and Cost-Effectiveness of Telerehabilitation for People With Nonspecific Chronic Low Back Pain: Randomized Controlled Trial.,"BACKGROUND


Telerehabilitation can facilitate multidisciplinary management for people with nonspecific chronic low back pain (NCLBP). It provides health care access to individuals who are physically and economically disadvantaged.
OBJECTIVE


This study aimed to evaluate the clinical and cost-effectiveness of telerehabilitation compared with a clinic-based intervention for people with NCLBP in Nigeria.
METHODS


A cost-utility analysis alongside a randomized controlled trial from a health care perspective was conducted. Patients with NCLBP were assigned to either telerehabilitation-based McKenzie therapy (TBMT) or clinic-based McKenzie therapy (CBMT). Interventions were carried out 3 times weekly for a period of 8 weeks. Patients' level of disability was measured using the Oswestry Disability Index (ODI) at baseline, week 4, and week 8. To estimate the health-related quality of life of the patients, the ODI was mapped to the short-form six dimensions instrument to generate quality-adjusted life years (QALYs). Health care resource use and costs were assessed based on the McKenzie extension protocol in Nigeria in 2019. Descriptive and inferential data analyses were also performed to assess the clinical effectiveness of the interventions. Bootstrapping was conducted to generate the point estimate of the incremental cost-effectiveness ratio (ICER).
RESULTS


A total of 47 patients (TBMT, n=21 and CBMT, n=26), with a mean age of 47 (SD 11.6) years for telerehabilitation and 50 (SD 10.7) years for the clinic-based intervention, participated in this study. The mean cost estimates of TBMT and CBMT interventions per person were 22,200 naira (US $61.7) and 38,200 naira (US $106), respectively. QALY gained was 0.085 for TBMT and 0.084 for CBMT. The TBMT arm was associated with an additional 0.001 QALY (95% CI 0.001 to 0.002) per participant compared with the CBMT arm. Thus, the ICER showed that the TBMT arm was less costly and more effective than the CBMT arm.
CONCLUSIONS


The findings of the study suggested that telerehabilitation for people with NCLBP was cost saving. Given the small number of participants in this study, further examination of effects and costs of the interventions is needed within a larger sample size. In addition, future studies are required to assess the cost-effectiveness of this intervention in the long term from the patient and societal perspective.",2020,The TBMT arm was associated with an additional 0.001 QALY (95% CI 0.001 to 0.002) per participant compared with the CBMT arm.,"['individuals who are physically and economically disadvantaged', 'Patients with NCLBP', 'People With Nonspecific Chronic Low Back Pain', '47 patients (TBMT, n=21 and CBMT, n=26) with a mean age of 47 (SD 11.6) years for telerehabilitation and 50 (SD 10.7) years for clinic-based intervention participated in this study', 'people with nonspecific chronic low back pain (NCLBP', 'people with NCLBP in Nigeria']","['TBMT', 'telerehabilitation compared with clinic-based intervention', 'telerehabilitation-based McKenzie therapy (TBMT) or clinic-based McKenzie therapy (CBMT']","['Oswestry Disability Index (ODI', 'level of disability', 'incremental cost-effectiveness ratio (ICER', 'mean costs estimate of TBMT']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}]","[{'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",47.0,0.12828,The TBMT arm was associated with an additional 0.001 QALY (95% CI 0.001 to 0.002) per participant compared with the CBMT arm.,"[{'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Fatoye', 'Affiliation': 'Faculty of Health, Psychology and Social Care, Manchester Metropolitan University, Manchester, United Kingdom.'}, {'ForeName': 'Tadesse', 'Initials': 'T', 'LastName': 'Gebrye', 'Affiliation': 'Faculty of Health, Psychology and Social Care, Manchester Metropolitan University, Manchester, United Kingdom.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Fatoye', 'Affiliation': 'Faculty of Health, Psychology and Social Care, Manchester Metropolitan University, Manchester, United Kingdom.'}, {'ForeName': 'Chidozie E', 'Initials': 'CE', 'LastName': 'Mbada', 'Affiliation': 'College of Health Sciences, Obafemi Awolowo University, Osun, Nigeria.'}, {'ForeName': 'Mistura I', 'Initials': 'MI', 'LastName': 'Olaoye', 'Affiliation': 'College of Health Sciences, Obafemi Awolowo University, Osun, Nigeria.'}, {'ForeName': 'Adesola C', 'Initials': 'AC', 'LastName': 'Odole', 'Affiliation': 'College of Medicine, University of Ibadan, Oyo, Nigeria.'}, {'ForeName': 'Olumide', 'Initials': 'O', 'LastName': 'Dada', 'Affiliation': 'College of Medicine, University of Ibadan, Oyo, Nigeria.'}]",JMIR mHealth and uHealth,['10.2196/15375']
14,32358836,Cost-effectiveness evaluation of the PROPPR trial transfusion protocols.,"BACKGROUND


There have been no prior investigations of the cost effectiveness of transfusion strategies for trauma resuscitation. The Pragmatic, Randomized, Optimal Platelet and Plasma Ratios (PROPPR) study was a Phase III multisite, randomized trial in 680 subjects comparing the efficacy of 1:1:1 transfusion ratios of plasma and platelets to red blood cells with the 1:1:2 ratio. We hypothesized that 1:1:1 transfusion results in an acceptable incremental cost-effectiveness ratio, when estimated using patients' age-specific life expectancy and cost of care during the 30-day PROPPR trial period.
STUDY DESIGN AND METHODS


International Classification of Diseases, Ninth Revision codes were prospectively collected, and subjects were matched 1:2 to subjects in the Healthcare Utilization Program State Inpatient Data to estimate cost weights. We used a decision tree analysis, combined with standard costs and estimated years of expected survival to determine the cost effectiveness of the two treatments.
RESULTS


The 1:1:1 group had higher overall costs for the blood products but were more likely to achieve hemostasis and decreased hemorrhagic death by 24 hours (p = 0.006). For every 100 patients treated in the 1:1:1 group, eight more achieved hemostasis than in the 1:1:2 group. At 30 days, the total hospital cost per 100 patients was $5.6 million in the 1:1:1 group compared with $5.0 million in the 1:1:2 group. For each 100 patients, the 1:1:1 group had 218.5 more years of life expectancy. This was at a cost of $2994 per year gained.
CONCLUSION


The 1:1:1 transfusion ratio in severely injured hemorrhaging trauma patients is a very cost-effective strategy for increasing hemostasis and decreasing trauma deaths.",2020,The 1:1:1 group had higher overall costs for the blood products but were more likely to achieve hemostasis and decreased hemorrhagic death by 24 hours (p = 0.006).,"['severely injured hemorrhaging trauma patients', '680 subjects', 'International Classification of Diseases, Ninth Revision codes were prospectively collected, and subjects were matched 1:2 to subjects in the Healthcare Utilization Program State Inpatient Data to estimate cost weights']",[],"['hemostasis', 'overall costs', 'hemorrhagic death', 'total hospital cost', 'life expectancy']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0870733', 'cui_str': 'International Statistical Classification of Diseases and Related Health Problems'}, {'cui': 'C0205443', 'cui_str': 'Ninth'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",[],"[{'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",680.0,0.0809202,The 1:1:1 group had higher overall costs for the blood products but were more likely to achieve hemostasis and decreased hemorrhagic death by 24 hours (p = 0.006).,"[{'ForeName': 'Rachael A', 'Initials': 'RA', 'LastName': 'Callcut', 'Affiliation': 'Division of General Surgery, Department of Surgery, School of Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Kit N', 'Initials': 'KN', 'LastName': 'Simpson', 'Affiliation': 'Department of Healthcare Leadership & Management, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Baraniuk', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Fox', 'Affiliation': 'Center for Translational Injury Research and Department of Surgery, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Tilley', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': 'Division of Acute Care Surgery, Department of Surgery, Center for Injury Science, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transfusion,['10.1111/trf.15784']
15,32358874,A Comparison of the Armeo to Tabletop-assisted Therapy Exercises as Supplemental Interventions in Acute Stroke Rehabilitation: A Randomized Single Blind Study.,"OBJECTIVES


To evaluate the feasibility of an additional therapeutic upper limb exercise (ULE) intervention in early phase post-stroke rehabilitation and to assess outcomes of therapy using the Armeo Spring (ARMEO) versus Therapist-assisted Table Top (TAT) interventions.
DESIGN


Randomized, single-blind trial.
SETTING


Stroke acute inpatient rehabilitation unit.
PARTICIPANTS


Forty-five participants early after first stroke, Fugl-Meyer Assessment (FMA) score >8, Modified Ashworth score (MAS) of <3.
INTERVENTIONS


Participants were randomized to TAT or ARMEO ULE in addition to the required 3 hours of 1:1 standard of care provided in an inpatient rehabilitation facility (IRF).
MAIN OUTCOME MEASURES


Completed number of treatments; withdrawals; serious/adverse events; Functional Independence Measure (FIM) motor; FIM efficiency; FMA; MAS; elbow active (A) and passive (P) range of motion (ROM); and therapist effort measured by the Modified Borg Rating of Perceived Exertion Scale (RPE).
RESULTS


Post-intervention FIM and FMA scores increased but did not demonstrate any statistically significant differences between the intervention groups (P = .585, .962, partial n 2  = .001, .001, respectively). There were no statistically significant differences in post-intervention MAS elbow flexion and extension (P = .332, .252, partial n 2  = .009, .007, respectively) and A/P ROM elbow extension between training groups (P = .841, .731, partial n 2  = .001, .003, respectively). There was a statistically significant difference in post-intervention A/P ROM elbow flexion between groups (P = .031, .018, partial n 2  = .123, .146). Post-intervention RPE did not show any statistically significant differences between the training groups (P = .128, partial n 2  = .063). Total elbow range showed larger adjusted mean gains for the ARMEO. No serious adverse events were reported.
CONCLUSIONS


This study demonstrates that additional therapeutic ULE in the early phase of post-stroke inpatient rehabilitation is feasible and that both interventions showed positive changes in selected outcomes.",2020,"RESULTS


Post-intervention FIM and FMA scores increased but did not demonstrate any statistically significant differences between the intervention groups (p = .585, .962, partial n 2  = .001,","['45 participants early after first stroke, Fugl Meyer Assessment (FMA) score >\u20098, Modified Ashworth score (MAS) of <3', 'Stroke acute inpatient rehabilitation unit', 'Acute Stroke Rehabilitation']","['additional therapeutic upper limb exercise (ULE) intervention', 'TAT or ARMEO ULE', 'inpatient rehabilitation facility (IRF', 'Therapist assisted Table Top (TAT) interventions', 'Armeo Spring ® (ARMEO) VS']","['post-intervention MAS elbow flexion and extension', 'P ROM elbow flexion', 'FMA scores', 'P ROM elbow extension', 'serious adverse events (SAEs', 'Completed number of treatments; withdrawals; serious/adverse events; Functional Independence Measure (FIM) Motor; FIM efficiency; FMA; MAS; elbow active (A) and passive (P) range of motion (ROM) and therapist effort measured by the Modified Borg Rating of Perceived Exertion Scale (RPE']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0454320', 'cui_str': 'Upper limb exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C3845566', 'cui_str': 'Rehabilitation facility'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",45.0,0.166516,"RESULTS


Post-intervention FIM and FMA scores increased but did not demonstrate any statistically significant differences between the intervention groups (p = .585, .962, partial n 2  = .001,","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Esquenazi', 'Affiliation': 'Department of PM&R, MossRehab, Elkins Park, PA, USA.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of PM&R, MossRehab, Elkins Park, PA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Department of PM&R, MossRehab, Elkins Park, PA, USA.'}, {'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Nastaskin', 'Affiliation': 'Department of PM&R, MossRehab, Elkins Park, PA, USA.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'McKee', 'Affiliation': 'Department of PM&R, MossRehab, Elkins Park, PA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': ""O'Neill"", 'Affiliation': 'Department of PM&R, MossRehab, Elkins Park, PA, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Scheponik', 'Affiliation': 'Department of PM&R, MossRehab, Elkins Park, PA, USA.'}, {'ForeName': 'Jaun', 'Initials': 'J', 'LastName': 'May', 'Affiliation': 'Department of PM&R, MossRehab, Elkins Park, PA, USA.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12397']
16,32367416,Impact of spectral body imaging in patients suspected for occult cancer: a prospective study of 503 patients.,"OBJECTIVES


To investigate the diagnostic impact and performance of spectral dual-layer detector CT in the detection and characterization of cancer compared to conventional CE-CT.
METHODS


In a national workup program for occult cancer, 503 patients (286 females and 217 males) were prospectively enrolled for a contrast-enhanced spectral CT scan. The readings were performed with and without spectral data available. A minimum of 3 months between interpretations was implemented to minimize recall bias. The sequence of reads for the individual patient was randomized. Readers were blinded for patient identifiers and clinical outcome. Two radiologists with 9 and 33 years of experience performed the readings in consensus. If disagreement, a third radiologist with 11 years of experience determined the outcome of the reading RESULTS: Significantly more cancer findings were identified on the spectral reading. In 73 cases of proven cancer, we found a sensitivity of 89% vs 77% and a specificity of 77% vs 83% on spectral CT compared to conventional CT. A slight increase in reading time in spectral images of 82 s was found (382 vs 300, p < 0.001). For all cystic lesions, the perceived diagnostic certainty increased from 30% being completely certain to 96% most pronounced in the kidney, liver, thyroid, and ovaries. And adding the spectral information to the reading gave a decrease in follow-up examination for diagnostic certainty (0.25 vs 0.81 per reading, p < 0.001).
CONCLUSION


The use of contrast-enhanced spectral CT increases the confidence of the radiologists in correct characterization of various lesions and minimizes the need for supplementary examinations.
KEY POINTS


• Spectral CT is associated with a higher sensitivity, but a slightly lower specificity compared to conventional CT. • Spectral CT increases the confidence of the radiologists. • The need for supplementary examinations is decreased, with only a slight increase in reading times.",2020,"For all cystic lesions, the perceived diagnostic certainty increased from 30% being completely certain to 96% most pronounced in the kidney, liver, thyroid, and ovaries.","['503 patients', '503 patients (286 females and 217 males', 'patients suspected for occult cancer']","['contrast-enhanced spectral CT', 'spectral dual-layer detector CT', 'spectral body imaging']","['diagnostic certainty', 'reading time in spectral images', 'reading times']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",503.0,0.0300193,"For all cystic lesions, the perceived diagnostic certainty increased from 30% being completely certain to 96% most pronounced in the kidney, liver, thyroid, and ovaries.","[{'ForeName': 'Michael Brun', 'Initials': 'MB', 'LastName': 'Andersen', 'Affiliation': 'Department of Radiology, Copenhagen University Hospital Herlev and Gentofte, Gentofte Hospitalsvej 1, 2900, Hellerup, Denmark. Michael.brun.andersen@regionh.dk.'}, {'ForeName': 'Dyveke', 'Initials': 'D', 'LastName': 'Ebbesen', 'Affiliation': 'Department of Radiology, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, Aarhus, 8200, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Thygesen', 'Affiliation': 'Department of Clinical Engineering, Central Denmark Region, Nørrebrogade 44, Building 2A, Aarhus, 8000, Denmark.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Kruis', 'Affiliation': 'Philips Medical Systems, Clinical Science, CT, Veenpluis 4-6, Best, 5684, The Netherlands.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Radiology, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, Aarhus, 8200, Denmark.'}]",European radiology,['10.1007/s00330-020-06878-7']
17,32378422,Effect of nocturnal melatonin intake on cellular damage and recovery from repeated sprint performance during an intensive training schedule.,"An optimal recovery between training sessions is of similar if not greater importance as the training content and program of the training, itself. One of the most used strategies for improving recovery is the ingestion of supplements. The present study aimed to evaluate the effect of 5 mg oral melatonin supplementation on the recovery from repeated sprint (RSA) of performance and biochemical responses ( i.e . oxidative stress, leukocytosis cellular damage) after an intensive training camp (TC). Twenty soccer players performed an RSA test before and after an intensive six-day TC associated with nocturnal melatonin (n = 10) or placebo (n = 10) ingestion. Resting and post-RSA test blood samples were obtained before and after the TC. Compared to placebo, melatonin intake decreased resting oxidative stress markers ( i.e , advanced oxidation protein products), leukocytosis ( i.e . white blood cells (WBC), neutrophils (NE)) and biomarkers of cellular damage ( i.e . creatine kinase (CK)). It also lowered post-exercise leukocytosis ( i.e . WBC, NE, lymphocytes (LY), monocytes (MO)) and biomarkers of cellular damage ( i.e . CK, aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT)) and raised the activity of the main antioxidant enzymes ( i.e . glutathione peroxidase (GPx), glutathione reductase (GR)). In addition, compared to placebo, melatonin reduced the deterioration of the best and total time during the RSA test after the TC. In conclusion, nocturnal melatonin supplementation during an intensive TC alleviated oxidative stress, leukocytosis and cellular damage and improved recovery of RSA performance in soccer players.",2020,"Compared to placebo, melatonin intake decreased resting oxidative stress markers ( i.e , advanced oxidation protein products), leukocytosis ( i.e . white blood cells (WBC), neutrophils (NE)) and biomarkers of cellular damage ( i.e . creatine kinase (CK)).","['Twenty soccer players', 'soccer players']","['intensive training camp (TC', 'nocturnal melatonin (n\xa0=\xa010) or placebo', 'oral melatonin supplementation', 'placebo, melatonin', 'nocturnal melatonin intake', 'nocturnal melatonin supplementation']","['cellular damage and recovery from repeated sprint performance', 'post-exercise leukocytosis ( i.e . WBC, NE, lymphocytes (LY), monocytes (MO)) and biomarkers of cellular damage ( i.e . CK, aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT)) and raised the activity of the main antioxidant enzymes ( i.e . glutathione peroxidase (GPx), glutathione reductase (GR', 'oxidative stress, leukocytosis and cellular damage and improved recovery of RSA performance', 'deterioration of the best and total time', 'resting oxidative stress markers ( i.e , advanced oxidation protein products), leukocytosis ( i.e . white blood cells (WBC), neutrophils (NE)) and biomarkers of cellular damage ( i.e . creatine kinase (CK', 'recovery from repeated sprint (RSA) of performance and biochemical responses ( i.e . oxidative stress, leukocytosis cellular damage']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0023518', 'cui_str': 'Leukocytosis'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0017824', 'cui_str': 'Glutathione reductase (NAD(P)H)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1976991', 'cui_str': 'Advanced oxidation protein products'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}]",,0.132672,"Compared to placebo, melatonin intake decreased resting oxidative stress markers ( i.e , advanced oxidation protein products), leukocytosis ( i.e . white blood cells (WBC), neutrophils (NE)) and biomarkers of cellular damage ( i.e . creatine kinase (CK)).","[{'ForeName': 'Mohamed Amine', 'Initials': 'MA', 'LastName': 'Farjallah', 'Affiliation': 'High Institute of Sport and Physical Education, Manouba University, Ksar-Saïd , Tunis, Tunisia.'}, {'ForeName': 'Kais', 'Initials': 'K', 'LastName': 'Ghattassi', 'Affiliation': 'High Institute of Sport and Physical Education, Manouba University, Ksar-Saïd , Tunis, Tunisia.'}, {'ForeName': 'Lobna', 'Initials': 'L', 'LastName': 'Ben Mahmoud', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, University of Sfax , Sfax, Tunisia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Graja', 'Affiliation': 'High Institute of Sport and Physical Education, Manouba University, Ksar-Saïd , Tunis, Tunisia.'}, {'ForeName': 'Mariem', 'Initials': 'M', 'LastName': 'Boudaya', 'Affiliation': 'Biochemistry Laboratory, CHU Hedi Chaker, University of Sfax , Sfax, Tunisia.'}, {'ForeName': 'Henda', 'Initials': 'H', 'LastName': 'Elleuch', 'Affiliation': 'Hematology Laboratory, CHU Hedi Chaker, University of Sfax , Sfax, Tunisia.'}, {'ForeName': 'Kamel', 'Initials': 'K', 'LastName': 'Jammoussi', 'Affiliation': 'Biochemistry Laboratory, CHU Hedi Chaker, University of Sfax , Sfax, Tunisia.'}, {'ForeName': 'Zouheir', 'Initials': 'Z', 'LastName': 'Sahnoun', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, University of Sfax , Sfax, Tunisia.'}, {'ForeName': 'Nizar', 'Initials': 'N', 'LastName': 'Souissi', 'Affiliation': 'Physical Activity, Sport and Health, UR18JS01, National Observatory of Sport , Tunis, Tunisia.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Chtourou', 'Affiliation': 'Physical Activity, Sport and Health, UR18JS01, National Observatory of Sport , Tunis, Tunisia.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Hammouda', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical Activity, Health and Learning (LINP2-APSA), UPL, Paris Nanterre University, UFR STAPS , Nanterre, France.'}]",Chronobiology international,['10.1080/07420528.2020.1746797']
18,32357269,A New Stimulation Mode for Deep Brain Stimulation in Parkinson's Disease: Theta Burst Stimulation.,"BACKGROUND AND OBJECTIVES


The purpose of this study was to assess efficacy and safety of a new patterned theta burst stimulation algorithm of DBS with the aim of expanding the therapeutic window and clinical benefit in PD.
METHODS


In this single-center, randomized, double-blind, clinical short-term trial, unilateral conventional subthalamic DBS was compared with unilateral patterned stimulation algorithms with intraburst high- or low-frequency theta burst stimulation in 17 PD patients.
RESULTS


There were no serious adverse events with theta burst stimulation. During monopolar review, conventional subthalamic DBS and high-frequency theta burst stimulation were comparable, but low-frequency theta burst stimulation differed by requiring higher stimulation amplitudes for symptom reduction, but a larger therapeutic window. High- and low-frequency theta burst stimulation with adapted stimulation amplitude were effective in PD symptom reduction with differential effects on akinesia and tremor, depending on the theta burst stimulation mode.
CONCLUSIONS


Theta burst stimulation is a safe and effective stimulation mode with potential future application opportunities. © 2020 International Parkinson and Movement Disorder Society.",2020,"High- and low-frequency theta burst stimulation with adapted stimulation amplitude were effective in PD symptom reduction with differential effects on akinesia and tremor, depending on the theta burst stimulation mode.
",['17 PD patients'],[],['efficacy and safety'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0932235,"High- and low-frequency theta burst stimulation with adapted stimulation amplitude were effective in PD symptom reduction with differential effects on akinesia and tremor, depending on the theta burst stimulation mode.
","[{'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Horn', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Neurology, Hamburg, Germany.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Gulberti', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Neurology, Hamburg, Germany.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Gülke', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Neurology, Hamburg, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Buhmann', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Neurology, Hamburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gerloff', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Neurology, Hamburg, Germany.'}, {'ForeName': 'Christian K E', 'Initials': 'CKE', 'LastName': 'Moll', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Neurophysiology and Pathophysiology, Hamburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hamel', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Neurosurgery, Hamburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Volkmann', 'Affiliation': 'University Hospital Würzburg, Department of Neurology, Würzburg, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Pötter-Nerger', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Neurology, Hamburg, Germany.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28083']
19,32357869,Identifying facilitators and barriers for adolescents participating in a school-based HIIT intervention: the eXercise for asthma with commando Joe's® (X4ACJ) programme.,"BACKGROUND


High-intensity interval training (HIIT) elicits numerous health benefits, but little evidence is available regarding the feasibility of delivering school-based HIIT interventions. The aim of this study was to explore adolescents' perceptions of a 6-month, 3 × 30-min sessions per week, HIIT intervention delivered either before or after school.
METHOD


Eighty adolescents allocated to the intervention group (13.3 ± 1.0 years; 45 boys) were invited to take part in semi-structured focus groups post-intervention. Participants were categorised as attendees (≥40% attendance) or non-attendees (< 5% attendance). Data were transcribed verbatim and thematically analysed deductively, with key emergent themes represented using pen profiles.
RESULTS


Results showed that a school-based HIIT intervention can be an enjoyable form of exercise. Irrespective of attendance, similar facilitators and barriers to participating were highlighted, including benefits of participation, content of the exercise session and the intervention instructor.
CONCLUSION


This study provides support for the delivery of a HIIT intervention in a school setting but highlights the importance of a flexible design and delivery to accommodate competing interests. There is a need to educate adolescents on the possible benefits of participation and to make the sessions enjoyable in order to increase their extrinsic and intrinsic motivation to sustain participation.",2020,Participants were categorised as attendees (≥40% attendance) or non-attendees (< 5% attendance).,"['Eighty adolescents allocated to the intervention group (13.3\u2009±\u20091.0\u2009years; 45 boys', ""adolescents participating in a school-based HIIT intervention: the eXercise for asthma with commando Joe's® (X4ACJ) programme"", 'Participants were categorised as attendees (≥40% attendance) or non-attendees (<\u20095% attendance']","['HIIT intervention', 'High-intensity interval training (HIIT']",[],"[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0325206,Participants were categorised as attendees (≥40% attendance) or non-attendees (< 5% attendance).,"[{'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Sharp', 'Affiliation': 'Public Health Collaborating Unit, School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Melitta A', 'Initials': 'MA', 'LastName': 'McNarry', 'Affiliation': 'Applied Sports Science Technology, Exercise and Medicine (A-STEM) Research Centre, College of Engineering, Bay Campus, Swansea University, Swansea, UK. m.mcnarry@swansea.ac.uk.'}, {'ForeName': 'William T B', 'Initials': 'WTB', 'LastName': 'Eddolls', 'Affiliation': 'Applied Sports Science Technology, Exercise and Medicine (A-STEM) Research Centre, College of Engineering, Bay Campus, Swansea University, Swansea, UK.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Koorts', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Charles O N', 'Initials': 'CON', 'LastName': 'Winn', 'Affiliation': 'Applied Sports Science Technology, Exercise and Medicine (A-STEM) Research Centre, College of Engineering, Bay Campus, Swansea University, Swansea, UK.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Mackintosh', 'Affiliation': 'Applied Sports Science Technology, Exercise and Medicine (A-STEM) Research Centre, College of Engineering, Bay Campus, Swansea University, Swansea, UK.'}]",BMC public health,['10.1186/s12889-020-08740-3']
20,32357944,Protocol for the trial to establish a causal linkage between mycotoxin exposure and child stunting: a cluster randomized trial.,"BACKGROUND


The number of stunted children has fallen globally but continues to increase in Africa. Stunting is estimated to contribute to 14-17% of child deaths under 5 years of age and is a risk factor for poor cognitive and motor development and educational outcomes. Inadequate dietary intake and disease are thought to be the immediate causes of undernutrition and stunting. However, improving infant diets through complementary feeding interventions has been shown to only modestly reduce stunting. Multiple observational studies demonstrate a dose response relationship between fetal and post-natal aflatoxin exposure and reduced linear growth.
METHODS


This community-based cluster randomized trial will measure the effect of a reduced aflatoxin diet on length-for-age Z scores at 18 months in central Tanzania. All 52 health facilities in the Kongwa District of Dodoma Region were randomized into two groups. Starting at 6 months of age, participants in the intervention group receive a low-aflatoxin pre-blended porridge flour containing maize and groundnut (ratio 4:1 respectively) and low-aflatoxin groundnut flour, whereas in the control group the same porridge mix and groundnut flour are promoted through education but acquired by the household. Both groups will receive the same infant and young child feeding education and a thermos flask. A total of 3120 infants between 6 weeks and 3 months of age will be recruited into the study over 1 year. Data will be collected four times - at recruitment and when the infants are 6, 12 and 18 months of age. In a cohort of 600 infants, additional data will be collected at 9 and 15 months of age. The primary outcome is length-for-age at 18 months. Secondary outcomes include the Z scores for weight-for-age, middle upper arm circumference and head circumference, and the blood biomarker aflatoxin-albumin in the full sample, with the urine biomarker aflatoxin M1 analyzed in the cohort only.
DISCUSSION


Better understanding the etiology of childhood stunting can lead to more appropriate interventions and policies to further reduce linear growth faltering and meet the Sustainable Development Goals.
TRIAL REGISTRATION


NCT03940547, (April 24, 2019).",2020,"Multiple observational studies demonstrate a dose response relationship between fetal and post-natal aflatoxin exposure and reduced linear growth.
","['3120 infants between 6\u2009weeks and 3\u2009months of age will be recruited into the study over 1 year', 'All 52 health facilities in the Kongwa District of Dodoma Region', '600 infants, additional data will be collected at 9 and 15\u2009months of age']","['reduced aflatoxin diet', 'low-aflatoxin pre-blended porridge flour containing maize and groundnut (ratio 4:1 respectively) and low-aflatoxin groundnut flour, whereas in the control group the same porridge mix and groundnut flour are promoted through education but acquired by the household']","['Z scores for weight-for-age, middle upper arm circumference and head circumference, and the blood biomarker aflatoxin-albumin in the full sample, with the urine biomarker aflatoxin M1', 'length-for-age Z scores', 'length-for-age at 18\u2009months']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001734', 'cui_str': 'Aflatoxin'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0452575', 'cui_str': 'Porridge'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0949399', 'cui_str': 'Peanut'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0020052', 'cui_str': 'Households'}]","[{'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0001734', 'cui_str': 'Aflatoxin'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0085181', 'cui_str': '4-Hydroxyaflatoxin B1'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",3120.0,0.0686382,"Multiple observational studies demonstrate a dose response relationship between fetal and post-natal aflatoxin exposure and reduced linear growth.
","[{'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Phillips', 'Affiliation': 'Independent Research Consultant, Arusha, Tanzania. elp28@cornell.edu.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Ngure', 'Affiliation': 'Independent Research Consultant, Arusha, Tanzania.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Smith', 'Affiliation': 'Department of Epidemiology and Environmental Health, School of Public Health and Health Professions, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Makule', 'Affiliation': 'Department of Food Biotechnology and Nutritional Sciences, School of Life Science and Bio-Engineering, The Nelson Mandela African Institution of Science and Technology (NM-AIST), P.O.Box 447, Arusha, Tanzania.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Turner', 'Affiliation': 'MIAEH, School of Public Health, University of Maryland, College Park, MD, 20740, USA.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Nelson', 'Affiliation': 'School of Integrative Plant Science, Plant Pathology and Plant-Microbe Biology Section, Cornell University, Ithaca, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kimanya', 'Affiliation': 'Department of Food Biotechnology and Nutritional Sciences, School of Life Science and Bio-Engineering, The Nelson Mandela African Institution of Science and Technology (NM-AIST), P.O.Box 447, Arusha, Tanzania.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Stoltzfus', 'Affiliation': 'Goshen College, 1700 S. Main Street, Goshen, Indiana, 46526, USA.'}, {'ForeName': 'Neema', 'Initials': 'N', 'LastName': 'Kassim', 'Affiliation': 'Department of Food Biotechnology and Nutritional Sciences, School of Life Science and Bio-Engineering, The Nelson Mandela African Institution of Science and Technology (NM-AIST), P.O.Box 447, Arusha, Tanzania.'}]",BMC public health,['10.1186/s12889-020-08694-6']
21,32361265,Randomised phase II trial of gemcitabine and nab-paclitaxel with necuparanib or placebo in untreated metastatic pancreas ductal adenocarcinoma.,"BACKGROUND


Necuparanib, a rationally engineered low-molecular-weight heparin, combined with gemcitabine/nab-paclitaxel showed an encouraging safety and oncologic signal in a phase Ib trial. This randomised multicentre phase II trial evaluates the addition of necuparanib or placebo to gemcitabine/nab-paclitaxel in untreated metastatic pancreatic ductal adenocarcinoma (PDAC).
PATIENTS AND METHODS


Eligibility included 18 years, histologically or cytologically confirmed metastatic PDAC, measurable disease and Eastern Co-Operative Oncology Group performance status of 0-1. Patients were randomly assigned to necuparanib (5 mg/kg subcutaneous injection once daily) or placebo (subcutaneous injection once daily) and gemcitabine/nab-paclitaxel on days 1, 8 and 15 of 28-day cycles. The primary end-point was median overall survival (OS), and secondary end-points included median progression-free survival, response rates and safety.
RESULTS


One-hundred ten patients were randomised, 62 to necuparanib arm and 58 to placebo arm. The futility boundary was crossed at a planned interim analysis, and the study was terminated by the Data Safety Monitoring Board. The median OS was 10.71 months (95% confidence interval [CI]: 7.95-11.96) for necuparanib arm and 9.99 months (95% CI: 7.85-12.85) for placebo arm (hazard ratio: 1.12, 95% CI: 0.66-1.89, P-value: 0.671). The necuparanib arm had a higher incidence of haematologic toxicity relative to placebo patients (83% and 70%).
CONCLUSION


The addition of necuparanib to standard of care treatment for advanced PDAC did not improve OS. Safety was acceptable. No further development of necuparanib is planned although targeting the coagulation cascade pathway remains relevant in PDAC. NCT01621243.",2020,"The necuparanib arm had a higher incidence of haematologic toxicity relative to placebo patients (83% and 70%).
","['One-hundred ten patients were randomised, 62 to necuparanib arm and 58 to', 'untreated metastatic pancreatic ductal adenocarcinoma (PDAC', 'Eligibility included 18 years, histologically or cytologically confirmed metastatic PDAC, measurable disease and Eastern Co-Operative Oncology Group performance status of 0-1', 'untreated metastatic pancreas ductal adenocarcinoma']","['gemcitabine/nab-paclitaxel', 'gemcitabine and nab-paclitaxel with necuparanib or placebo', 'necuparanib (5\xa0mg/kg subcutaneous injection once daily) or placebo (subcutaneous injection once daily) and gemcitabine/nab-paclitaxel', 'necuparanib or placebo to gemcitabine/nab-paclitaxel', 'placebo']","['median OS', 'haematologic toxicity', 'median overall survival (OS), and secondary end-points included median progression-free survival, response rates and safety', 'safety and oncologic signal']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205488', 'cui_str': 'Hematologic'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",110.0,0.686627,"The necuparanib arm had a higher incidence of haematologic toxicity relative to placebo patients (83% and 70%).
","[{'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA. Electronic address: oreillye@mskcc.org.'}, {'ForeName': 'Diletta', 'Initials': 'D', 'LastName': 'Barone', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Devalingam', 'Initials': 'D', 'LastName': 'Mahalingam', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Tanios', 'Initials': 'T', 'LastName': 'Bekaii-Saab', 'Affiliation': 'Mayo Clinic Cancer Center, Scottsdale, AZ, USA; ACCRU Research Consortium, Rochester, MN, USA.'}, {'ForeName': 'Spencer H', 'Initials': 'SH', 'LastName': 'Shao', 'Affiliation': 'Compass Oncology, Rose Quarter Cancer Center, Portland, OR, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Wolf', 'Affiliation': 'Momenta Pharmaceuticals, Inc., 301 Binney Street, Cambridge, MA 02142, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Rosano', 'Affiliation': 'Momenta Pharmaceuticals, Inc., 301 Binney Street, Cambridge, MA 02142, USA.'}, {'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Krause', 'Affiliation': 'Momenta Pharmaceuticals, Inc., 301 Binney Street, Cambridge, MA 02142, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Richards', 'Affiliation': 'Texas Oncology, US Oncology Research, 910 East Houston Street, Tyler, TX 71702, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Yu', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Roach', 'Affiliation': 'Momenta Pharmaceuticals, Inc., 301 Binney Street, Cambridge, MA 02142, USA.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Massachussetts General Hospital, 55 Fruit Street, Boston, MA 02114-2696, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Ryan', 'Affiliation': 'Massachussetts General Hospital, 55 Fruit Street, Boston, MA 02114-2696, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.03.005']
22,32364838,Effects of Silicone Hydrocoated Double Loop Ureteral Stent on Symptoms and Quality of Life in Patients Undergoing Flexible Ureteroscopy for Kidney Stone: A Randomized Multicenter Clinical Study.,"PURPOSE


We compared the hydrocoated silicone stent (Coloplast Imajin® hydro) to Percuflex™ Plus stent (Boston Scientific) in terms of patient comfort and quality of life after flexible ureteroscopy for stone disease over a 5-week prospective followup.
MATERIALS AND METHODS


This is a multicenter, single-blind, prospective, randomized trial of 141 patients treated with flexible ureteroscopy for renal stones. Primary outcome was Ureteral Stent Symptom Questionnaire (USSQ) Body Pain Index recorded before Double-J® stent removal at day (D) 20. Secondary endpoints were USSQ scores at intermediate dates (D2, D7, D20) and 2 weeks after stent withdrawal (D35), occurrence of adverse events and stent encrustation.
RESULTS


The trial was completed by 113 (80.1%) patients. Mean (SD) USSQ body pain scores were 25% lower at D20 for the silicone stent at 18.7 (11.4) vs 25.1 (14.2) (p=0.015). No difference in terms of adverse events and safety profile was observed. USSQ urinary symptoms scores at D2, D7 and D20 were lower in the silicone stent group at 26.4 (7.7) vs 31.8 (8.1) at D20 (p <0.001). The use of USSQ self-questionnaires was associated with a limited number of missing or incomplete answers.
CONCLUSIONS


The primary results of this large sample prospective randomized controlled study comparing the silicone Imajin hydro stents to the Percuflex Plus stent show that silicone stents are associated with significantly less patient discomfort. We would recommend their use in patients who require stenting for stone disease.",2020,Imajin® hydro result in lower pain and discomfort following flexible ureteroscopy as compared to Percuflex TM  ,"['patients who require stenting for stone disease', '141 patients treated with fURS for renal stones', 'Patients Undergoing Flexible Ureteroscopy for Kidney Stone']","['silicone DJ stents', 'flexible ureteroscopy (fURS', 'hydrocoated silicone stent (Coloplast Imajin® hydro) to Percuflex TM  Plus stent (Boston Scientific', 'flexible ureteroscopy', 'Materials and Methdos', 'Silicone Hydrocoated Double Loop Ureteral Stent', 'silicone Imajin® hydro stents', 'Percuflex TM']","['USSQ Body Pain Index recorded before DJ removal at day 20 (D20', 'Symptoms and Quality of Life', 'USSQ scores at intermediate dates (D2, D7, D20) and 2 weeks after stent withdrawal (D35), occurrence of adverse events and stent encrustation', 'patient discomfort', 'Mean (SD) USSQ body pain scores', 'USSQ urinary symptoms scores at D2, D7 and D20', 'pain and discomfort', 'adverse events and safety profile']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0070387', 'cui_str': 'percuflex TM'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",141.0,0.171524,Imajin® hydro result in lower pain and discomfort following flexible ureteroscopy as compared to Percuflex TM  ,"[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Wiseman', 'Affiliation': ""Urology Department, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.""}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Ventimiglia', 'Affiliation': 'Division of Experimental Oncology/Unit of Urology; URI; IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Steeve', 'Initials': 'S', 'LastName': 'Doizi', 'Affiliation': ""Sorbonne Université, Service d'Urologie, AP-HP, Hôpital Tenon, Paris, France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Kleinclauss', 'Affiliation': 'Department of Urology and Renal Transplantation, CHRU Besancon, Besancon, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Letendre', 'Affiliation': 'Maisonneuve-Rosemont Hospital, Urology, Montreal, Quebec, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cloutier', 'Affiliation': 'University Hospital Centre of Quebec City, Urology, Quebec, Quebec, Canada.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Traxer', 'Affiliation': ""Sorbonne Université, Service d'Urologie, AP-HP, Hôpital Tenon, Paris, France.""}]",The Journal of urology,['10.1097/JU.0000000000001098']
23,32366796,Acute Photobiomodulation by LED Does Not Alter Muscle Fatigue and Cycling Performance.,"PURPOSE


The purpose of the present study was to investigate the ergogenic effects of two doses of photobiomodulation therapy (PBMT) in comparison to placebo on markers of respiratory and muscle activity, blood acid-base, ion and lactate concentrations, indicators of muscle fatigue (global, central, and peripheral), and time to exhaustion in severe-intensity cycling.
METHODS


Two separate studies were performed, both in a pseudorandomized and balanced, crossover design. In study 1, 14 male recreational cyclists completed three constant-load, severe-intensity cycling bouts that were duration matched. The PBMT (18 × 38 cm array with 200 diodes) treatments occurred before bouts at 260, 130, or 0 J (placebo) doses. EMG activity of selected lower limb musculature was assessed during each bout. Maximal voluntary contractions of knee extension with peripheral nerve stimulations and EMG activity evaluation of vastus lateralis was also performed before and after cycling. In study 2, 13 recreational cyclists performed three bouts of constant-load, severe-intensity cycling until exhaustion, preceded by PBMT as detailed previously. Blood lactate concentrations, respiratory responses, EMG activity, and capillary gasometry aspects were monitored.
RESULTS


In both studies, there were no interactions effects (time-condition) on the EMG activity, which was displayed as root mean square (P ≥ 0.168) and median frequency (P ≥ 0.055) during cycling. In study 1, there were no interaction effects on the indicators of muscle fatigue after exercise (P ≥ 0.130). In study 2, there were no differences on time to exhaustion (P = 0.353) and no interaction effects among the physiological responses monitored (P ≥ 0.082).
CONCLUSIONS


Based on our findings, the PBMT at 260- and 130-J doses does not have a beneficial effect on muscle fatigue, cycling performance, metabolic parameters, and muscle activity in male recreational cyclists.",2020,"In Study 1, there were no interaction effects on the indicators of muscle fatigue after exercise (P≥0.130).","['thirteen recreational cyclists', 'male recreational cyclists', 'fourteen male recreational cyclists completed three constant-load severe-intensity cycling bouts with duration-matched']","['photobiomodulation therapy (PBMT', 'placebo']","['root mean square', 'time to exhaustion', 'Blood lactate concentrations, respiratory responses, EMG activity and capillary gasometry aspects', 'markers of respiratory and muscle activity, blood acid-base, ion and lactate concentrations, indicators of muscle fatigue (global, central, and peripheral), and time to exhaustion in severe-intensity cycling', 'Electromyographic activity (EMG) of selected lower limb musculature', 'EMG activity', 'Muscle Fatigue and Cycling Performance', 'muscle fatigue', 'muscle fatigue, cycling performance, metabolic parameters and muscle activity']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",14.0,0.197945,"In Study 1, there were no interaction effects on the indicators of muscle fatigue after exercise (P≥0.130).","[{'ForeName': 'Yago Medeiros', 'Initials': 'YM', 'LastName': 'Dutra', 'Affiliation': 'Laboratory of Physiology and Sport Performance (LAFIDE), São Paulo State University (UNESP), Bauru, SP, BRAZIL.'}, {'ForeName': 'Gabriel Machado', 'Initials': 'GM', 'LastName': 'Claus', 'Affiliation': 'Laboratory of Physiology and Sport Performance (LAFIDE), São Paulo State University (UNESP), Bauru, SP, BRAZIL.'}, {'ForeName': 'Elvis DE Souza', 'Initials': 'ES', 'LastName': 'Malta', 'Affiliation': 'Laboratory of Physiology and Sport Performance (LAFIDE), São Paulo State University (UNESP), Bauru, SP, BRAZIL.'}, {'ForeName': 'Gabriel Motta Pinheiro', 'Initials': 'GMP', 'LastName': 'Brisola', 'Affiliation': 'Laboratory of Physiology and Sport Performance (LAFIDE), São Paulo State University (UNESP), Bauru, SP, BRAZIL.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Esco', 'Affiliation': 'Exercise Physiology Laboratory, Department of Kinesiology, University of Alabama, Tuscaloosa, AL.'}, {'ForeName': 'Cleber', 'Initials': 'C', 'LastName': 'Ferraresi', 'Affiliation': 'Biomedical Engineering Postgraduate Program, Universidade Brasil, São Paulo, SP, BRAZIL.'}, {'ForeName': 'Alessandro Moura', 'Initials': 'AM', 'LastName': 'Zagatto', 'Affiliation': 'Laboratory of Physiology and Sport Performance (LAFIDE), São Paulo State University (UNESP), Bauru, SP, BRAZIL.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002394']
24,32366799,Power of Words: Influence of Preexercise Information on Hypoalgesia after Exercise-Randomized Controlled Trial.,"PURPOSE


Exercise increases pressure pain thresholds (PPT) in pain-free individuals, known as exercise-induced hypoalgesia (EIH). Positive preexercise information can elicit higher EIH responses, but the effect of positive versus negative preexercise information on EIH is unknown. The primary aim of this randomized controlled trial was to compare EIH at the exercising thigh muscle after an isometric squat exercise between individuals receiving positive versus negative preexercise information about the effect of exercise on pain. Secondary aims were to compare EIH at nonexercising muscles between groups, and to investigate the relationship between participants' expectations and EIH.
METHODS


Eighty-three participants were randomly assigned to brief positive (n = 28), neutral (n = 28) or negative (n = 27) verbal information. The neutral information group was included in the study as a reference group. Pressure pain thresholds at the thigh and trapezius muscles were assessed before and after the intervention (i.e., preexercise information+squat exercise). Expectations of pain relief were assessed using a numerical rating scale (-10 [most negative] to 10 [most positive]).
RESULTS


Change in quadriceps and trapezius PPT after the squat exercise showed a large difference between the positive and negative information groups (quadriceps, 102 kPa; 95% confidence interval, 55-150; effect size, 1.2; trapezius, 41 kPa; 95% confidence interval, 16-65; effect size:, 0.9). The positive information group had a 22% increase in quadriceps PPT whereas the negative information group had a 4% decrease. A positive correlation was found between expectations and increase in PPT.
CONCLUSIONS


Negative preexercise information caused hyperalgesia after the wall squat exercise, whereas positive or neutral preexercise information caused hypoalgesia. Positive preexercise information did not change the magnitude of EIH compared with neutral information.",2020,The positive information group had a 22% increase in quadriceps PPT whereas the negative information group had a 4% decrease.,"['Eighty-three participants were randomly assigned to brief positive (n=28), neutral (n=28) or negative (n=27) verbal information', 'pain-free individuals, known as exercise-induced hypoalgesia (EIH']","['Preexercise Information', 'isometric squat exercise']","['pain relief', 'hyperalgesia', 'PPT', 'pain', 'numerical rating scale', 'pressure pain thresholds (PPT', 'quadriceps PPT']","[{'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0085625', 'cui_str': 'Hypoalgesia'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",83.0,0.194372,The positive information group had a 22% increase in quadriceps PPT whereas the negative information group had a 4% decrease.,"[{'ForeName': 'Henrik Bjarke', 'Initials': 'HB', 'LastName': 'Vaegter', 'Affiliation': 'Pain Research Group, Pain Center, Odense University Hospital, Odense, DENMARK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Thinggaard', 'Affiliation': 'Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, DENMARK.'}, {'ForeName': 'Casper HØj', 'Initials': 'CH', 'LastName': 'Madsen', 'Affiliation': 'Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, DENMARK.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Hasenbring', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, Faculty of Medicine, Ruhr University Bochum, Bochum, GERMANY.'}, {'ForeName': 'Jonas Bloch', 'Initials': 'JB', 'LastName': 'Thorlund', 'Affiliation': 'Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, DENMARK.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002396']
25,32363616,"The effect of synbiotic supplementation on anthropometric indices, appetite, and constipation in people with hypothyroidism: A randomized, double-blind, placebo-controlled trial.","Hypothyroidism and obesity are two highly prevalent conditions that appear to be closely related. Hypothyroidism is correlated with weight gain, loss of appetite, constipation, and a higher incidence of obesity. The present study aimed to investigate the effects of synbiotic supplementation on anthropometric indices, appetite, and constipation in subjects with hypothyroidism. Sixty subjects with hypothyroidism were assigned into two groups to receive either 500 mg/day of synbiotic (n = 30) or a placebo (n = 30) per day for 8 weeks. Anthropometric indices, appetite, and constipation were assessed at study baseline and end of the trial. At the end of trial, waist-to-hip ratio was significantly decreased in the synbiotic group (p = .030), whereas there were no significant differences between groups. We did not observe any statistically significant change in appetite or other anthropometric indices (p > .05). Compared with the placebo synbiotic supplementation led to a significant reduction in constipation (p = .048). The results of the present trial indicated that synbiotic supplementation may have favorable results in constipation among subjects with hypothyroidism for 8 weeks. Further studies with larger sample size and longer duration are needed to confirm our findings.",2020,Compared with the placebo synbiotic supplementation led to a significant reduction in constipation (p = .048).,"['people with hypothyroidism', 'subjects with hypothyroidism', 'subjects with hypothyroidism for 8\u2009weeks', 'Sixty subjects with hypothyroidism']","['500\u2009mg/day of synbiotic', 'synbiotic supplementation', 'placebo synbiotic supplementation', 'placebo']","['waist-to-hip ratio', 'appetite or other anthropometric indices', 'Anthropometric indices, appetite, and constipation', 'anthropometric indices, appetite, and constipation', 'weight gain, loss of appetite, constipation', 'constipation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}]",60.0,0.458891,Compared with the placebo synbiotic supplementation led to a significant reduction in constipation (p = .048).,"[{'ForeName': 'Sepide', 'Initials': 'S', 'LastName': 'Talebi', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Karimifar', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Heidari', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohammadi', 'Affiliation': 'Food Security Research Center and Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Asbaghi', 'Affiliation': 'Student Research Committee, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Hadi', 'Affiliation': 'Halal Research Center of IRI, FDA, Tehran, Iran.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Marx', 'Affiliation': 'iMPACT, School of Medicine, Deakin University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Askari', 'Affiliation': 'Food Security Research Center and Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6710']
26,32360236,"Evaluation of the Efficacy of Hilotherapy for Postoperative Edema, Ecchymosis, and Pain After Rhinoplasty.","PURPOSE


Edema and ecchymosis are among the most important morbidities after rhinoplasty. The aim of the present study was to investigate the effects of hilotherapy application compared with traditional ice applications after rhinoplasty in terms of periorbital edema, ecchymosis, and pain.
PATIENTS AND METHODS


A total of 60 patients (35 women and 25 men) had undergone primary rhinoplasty with the same surgeon. In the postoperative period, 30 patients in the study group received continuous cooling at 15°C using Hilotherm (Hilotherm GmbH, Argenbühl-Eisenharz, Germany), and 30 patients in the control group were treated with conventional cryotherapy with ice packs. Both treatments started within 45 minutes after the end of the surgery and were maintained for 24 hours. For the following 1 week, the patients were examined for edema, ecchymosis, and pain.
RESULTS


When the postoperative periorbital region was evaluated for mean edema and mean ecchymosis for 7 days, less edema and less ecchymosis were detected in the Hilotherm group compared with that observed in the ice pack group (P < .001). When the mean pain scores were compared both morning and evening for 7 days, less pain had been recorded with Hilotherm application compared with ice application (P < .001).
CONCLUSIONS


Hilotherapy is a useful method to prevent postoperative edema, ecchymosis, and pain compared with traditional ice application.",2020,"When the mean pain scores were compared both morning and evening for 7 days, less pain had been recorded with Hilotherm application compared with ice application (P < .001).
",['60 patients (35 women and 25 men) had undergone primary rhinoplasty with the same surgeon'],"['conventional cryotherapy with ice packs', 'continuous cooling at 15°C using Hilotherm (Hilotherm GmbH, Argenbühl-Eisenharz, Germany', 'hilotherapy application', 'Hilotherapy']","['edema, ecchymosis, and pain', 'postoperative edema, ecchymosis, and pain', 'mean edema and mean ecchymosis', 'mean pain scores', 'pain', 'periorbital edema, ecchymosis, and pain', 'edema and less ecchymosis', 'Postoperative Edema, Ecchymosis, and Pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0181264', 'cui_str': 'Ice bag'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0151205', 'cui_str': 'Periorbital edema'}]",60.0,0.0248466,"When the mean pain scores were compared both morning and evening for 7 days, less pain had been recorded with Hilotherm application compared with ice application (P < .001).
","[{'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Hanci', 'Affiliation': 'Specialist, Department of Otorhinolaryngology Okmeydani Training and Research Hospital, Istanbul, Turkey. Electronic address: dhanci007@hotmail.com.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Üstün', 'Affiliation': 'Specialist, Department of Otorhinolaryngology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ayça Başkadem', 'Initials': 'AB', 'LastName': 'Yılmazer', 'Affiliation': 'Specialist, Department of Otorhinolaryngology Okmeydani Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ayşe Enise', 'Initials': 'AE', 'LastName': 'Göker', 'Affiliation': 'Specialist, Department of Otorhinolaryngology Okmeydani Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Semih', 'Initials': 'S', 'LastName': 'Karaketir', 'Affiliation': 'Specialist, Department of Otorhinolaryngology Okmeydani Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Uyar', 'Affiliation': 'Professor Doctor and Department Head, Department of Otorhinolaryngology, Okmeydani Training and Research Hospital, Istanbul, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.03.032']
27,32369162,"Free and Glucuronide Urine Cannabinoids after Controlled Smoked, Vaporized and Oral Cannabis Administration in Frequent and Occasional Cannabis Users.","Total urinary 11-nor-9-carboxy-tetrahydrocannabinol (THCCOOH) concentrations are generally reported following cannabis administration. Few data are available for glucuronide and minor cannabinoid metabolite concentrations. All urine specimens from 11 frequent and 9 occasional cannabis users were analyzed for 11 cannabinoids for ~85 h by liquid chromatography with tandem mass spectrometry following controlled smoked, vaporized or oral 50.6 mg Δ9-tetrahydrocannabinol (THC) in a randomized, placebo-controlled, within-subject dosing design. No cannabidiol, cannabinol, cannabigerol, tetrahydrocannabivarin (THCV), THC, 11-OH-THC and Δ9-tetrahydrocannabinolic acid were detected in urine. Median THCCOOH-glucuronide maximum concentrations (Cmax) following smoked, vaporized and oral routes were 68.0, 26.7 and 360 μg/L for occasional and 378, 248 and 485 μg/L for frequent users, respectively. Median time to specific gravity-normalized Cmax (Tmax) was 5.1-7.9 h for all routes and all users. Median Cmax for THCCOOH, THC-glucuronide and 11-nor-9-carboxy-Δ9-THCV (THCVCOOH) were <7.5% of THCCOOH-glucuronide Cmax concentrations. Only THC-glucuronide mean Tmax differed between routes and groups, and was often present only in occasional users' first urine void. Multiple THCCOOH-glucuronide and THCCOOH peaks were observed. We also evaluated these urinary data with published models for determining recency of cannabis use. These urinary cannabinoid marker concentrations from occasional and frequent cannabis users following three routes of administration provide a scientific database to assess single urine concentrations in cannabis monitoring programs. New target analytes (CBD, CBN, CBG, THCV and phase II metabolites) were not found in urine. The results are important to officials in drug treatment, workplace and criminal justice drug monitoring programs, as well as policy makers with responsibility for cannabis regulations.",2020,"Only THC-glucuronide mean Tmax differed between routes and groups, and was often present only in occasional users' first urine void.","['Frequent and Occasional Cannabis Users', 'All urine specimens from 11 frequent and 9 occasional cannabis users']","['vaporized or oral 50.6\xa0mg Δ9-tetrahydrocannabinol (THC', 'placebo']","['Median THCCOOH-glucuronide maximum concentrations (Cmax', 'Only THC-glucuronide mean Tmax', 'THC, 11-OH-THC, Δ9-tetrahydrocannabinolic acid', 'No cannabidiol, cannabinol, cannabigerol, tetrahydrocannabivarin (THCV', 'Median time to specific-gravity normalized Cmax (Tmax', 'New target analytes (CBD, CBN, CBG, THCV and phase II metabolites', 'Median Cmax for THCCOOH, THC-glucuronide and 11-nor-9-carboxy-Δ9-THCV (THCVCOOH']","[{'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037786', 'cui_str': 'Specific gravity'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0006865', 'cui_str': 'Cannabinol'}, {'cui': 'C0054593', 'cui_str': 'cannabigerol'}, {'cui': 'C3869806', 'cui_str': 'Tetrahydrocannabivarin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0443354', 'cui_str': 'Analyte'}, {'cui': 'C1452313', 'cui_str': 'CBG'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0587949,"Only THC-glucuronide mean Tmax differed between routes and groups, and was often present only in occasional users' first urine void.","[{'ForeName': 'Marilyn A', 'Initials': 'MA', 'LastName': 'Huestis', 'Affiliation': 'Chemistry and Drug Metabolism, Intramural Research Program, National Institute on Drug Abuse, National Institutes of Health, 5500 Nathan Shock Drive, Baltimore, MD 21224, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sempio', 'Affiliation': 'Chemistry and Drug Metabolism, Intramural Research Program, National Institute on Drug Abuse, National Institutes of Health, 5500 Nathan Shock Drive, Baltimore, MD 21224, USA.'}, {'ForeName': 'Matthew N', 'Initials': 'MN', 'LastName': 'Newmeyer', 'Affiliation': 'Chemistry and Drug Metabolism, Intramural Research Program, National Institute on Drug Abuse, National Institutes of Health, 5500 Nathan Shock Drive, Baltimore, MD 21224, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Andersson', 'Affiliation': 'Chemistry and Drug Metabolism, Intramural Research Program, National Institute on Drug Abuse, National Institutes of Health, 5500 Nathan Shock Drive, Baltimore, MD 21224, USA.'}, {'ForeName': 'Allan J', 'Initials': 'AJ', 'LastName': 'Barnes', 'Affiliation': 'Chemistry and Drug Metabolism, Intramural Research Program, National Institute on Drug Abuse, National Institutes of Health, 5500 Nathan Shock Drive, Baltimore, MD 21224, USA.'}, {'ForeName': 'Osama A', 'Initials': 'OA', 'LastName': 'Abulseoud', 'Affiliation': 'Intramural Research Program, National Institute on Drug Abuse, National Institutes of Health, 5500 Nathan Shock Drive, Baltimore, MD 21224.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Blount', 'Affiliation': 'Center for Disease Control and Prevention, National Center for Environmental Health, Division of Laboratory Sciences, Tobacco and Volatiles Branch, 4770 Buford Highway, NE, Atlanta, GA 30341.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Schroeder', 'Affiliation': 'Office of the Clinical Director, Intramural Research Program, National Institute on Drug Abuse, National Institutes of Health, 251 Bayview Blvd., Baltimore, MD 21224.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Smith', 'Affiliation': 'Huestis & Smith Toxicology, LLC, 683 Shore Road, Severna Park, MD 21146.'}]",Journal of analytical toxicology,['10.1093/jat/bkaa046']
28,32374130,Editorial Comment: Laparoscopy versus robotic-assisted pyeloplasty in children: pre-liminary results of a pilot prospective ran-domized controlled trial.,,2020,,['children'],['Editorial Comment: Laparoscopy versus robotic-assisted pyeloplasty'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0282411', 'cui_str': 'Editorial Comment'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0554139', 'cui_str': 'Pyeloplasty'}]",[],,0.0347665,,"[{'ForeName': 'Eliney F', 'Initials': 'EF', 'LastName': 'Faria', 'Affiliation': 'Serviço de Urologia, Hospital Felicio Rocho, Belo Horizonte, MG, Brasil.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2020.04.05']
29,32365398,Effects of Short Term Metformin Treatment on Brown Adipose Tissue Activity and Plasma Irisin Levels in Women with Polycystic Ovary Syndrome: A Randomized Controlled Trial.,"Polycystic ovary syndrome (PCOS) is a chronic dysfunction associated with obesity and metabolic disorders that can be ameliorated by treatment with metformin. Brown adipose tissue (BAT) has been recently identified in adult humans, and irisin is a myokine that induces BAT formation. The aim of this randomized controlled trial was to evaluate whether a short term treatment with metformin alters BAT activity and plasma irisin levels in women with PCOS. The participants were randomly assigned to receive metformin (1500 mg/day, n=21) or placebo (n=24) during 60 days. BAT activity was assessed by  18 F-FDG positron emission tomography-computed tomography (PET-CT) and plasma irisin levels were measured by enzyme immunoassay. The groups were similar in age, body measures, metabolic profile and PCOS phenotypes. BAT activity did not change significantly in the women treated with metformin (median Δ SUV max =-0.06 g/ml, interquartile interval -2.81 to 0.24 g/ml, p=0.484, Wilcoxon's test) or placebo (median Δ SUV max =0.98 g/ml, interquartile interval -2.94 to 4.60 g/ml, p=0.386). In addition, plasma irisin levels remained unchanged in the groups treated with metformin (median Δ=-98 ng/ml, interquartile interval -366 to 60 ng/ml, p=0.310) and placebo (median Δ=28 ng/ml, interquartile interval -1260 to 215 ng/ml, p=0.650). These results suggest that in PCOS women BAT activity and plasma irisin levels may not change after a brief treatment with metformin.",2020,BAT activity did not change significantly in the women treated with metformin (median Δ SUV max =,"['Polycystic ovary syndrome (PCOS', 'women with PCOS', 'Women with Polycystic Ovary Syndrome']","['Short Term Metformin', 'Brown adipose tissue (BAT', 'metformin', 'placebo']","['BAT activity', 'PCOS women BAT activity and plasma irisin levels', 'Brown Adipose Tissue Activity and Plasma Irisin Levels', 'BAT activity and plasma irisin levels', 'plasma irisin levels']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.483508,BAT activity did not change significantly in the women treated with metformin (median Δ SUV max =,"[{'ForeName': 'Flávia R', 'Initials': 'FR', 'LastName': 'Oliveira', 'Affiliation': 'Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Mamede', 'Affiliation': 'Department of Anatomy and Imaging, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Mariana F', 'Initials': 'MF', 'LastName': 'Bizzi', 'Affiliation': 'Department of Internal Medicine, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Ana Luiza L', 'Initials': 'ALL', 'LastName': 'Rocha', 'Affiliation': 'Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Cláudia N', 'Initials': 'CN', 'LastName': 'Ferreira', 'Affiliation': 'Technical College, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Karina B', 'Initials': 'KB', 'LastName': 'Gomes', 'Affiliation': 'Clinical and Toxicological Analyses, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'Cândido', 'Affiliation': 'Department of Internal Medicine, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Fernando M', 'Initials': 'FM', 'LastName': 'Reis', 'Affiliation': 'Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}]",Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme,['10.1055/a-1157-0615']
30,32300012,"Social, psychological, and demographic characteristics of dehumanization toward immigrants.","This study extends the current body of work on dehumanization by evaluating the social, psychological, and demographic correlates of blatant disregard for immigrants. Participants ( n  = 468) were randomly assigned to read a scenario where 1) an immigrant or 2) an immigrant and their child were caught illegally crossing the southern border of the United States, and then rated how long they should spend in jail if convicted. Participants reported that they would sentence the immigrant to more jail time than the immigrant and child. Those who sent immigrants to jail for more time also viewed them as socially distant and less human, described immigration in impersonal terms, and endorsed other social harms unrelated to immigration (e.g., the death penalty for convicted murderers). Crucially, endorsed social harms accounted for explained variance beyond simply holding conservative views. We position these data within the current literature on dehumanization theory and immigration issues.",2020,"Those who sent immigrants to jail for more time also viewed them as socially distant and less human, described immigration in impersonal terms, and endorsed other social harms unrelated to immigration (e.g., the death penalty for convicted murderers).","['Participants ( n  = 468', 'immigrants']",[],['jail time'],"[{'cui': 'C0282163', 'cui_str': 'Immigrant'}]",[],"[{'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",468.0,0.0240809,"Those who sent immigrants to jail for more time also viewed them as socially distant and less human, described immigration in impersonal terms, and endorsed other social harms unrelated to immigration (e.g., the death penalty for convicted murderers).","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Markowitz', 'Affiliation': 'School of Journalism and Communication, University of Oregon, Eugene, OR 97403.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Slovic', 'Affiliation': 'Decision Research, Eugene, OR 97401; pslovic@uoregon.edu.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1921790117']
31,32303763,Acute Cognitive Effects of the Hypocretin Receptor Antagonist Almorexant Relative to Zolpidem and Placebo: A Randomized Clinical Trial.,"STUDY OBJECTIVES


Hypnotic medications can adversely affect behavior during unanticipated awakenings during the night. Animals treated with the hypocretin receptor antagonist almorexant (ALM) have less acute cognitive impairment compared to the GABAA receptor modulator zolpidem (ZOL). This study aimed to determine whether ALM produces less acute cognitive impairment than ZOL in human subjects.
METHODS


Healthy, young adult, unmedicated male and female subjects participated in a controlled trial of a single dose of ALM 100mg (N = 48), ALM 200mg (N = 53), ZOL 10mg (N = 49), and placebo (PBO, N = 52).
RESULTS


ZOL and both doses of ALM produced similar levels of subjective sleepiness and impaired the ability of subjects to remain awake in a dark, low stimulus setting relative to PBO. For most cognitive measures, performance under ZOL was significantly worse than ALM or PBO. For tasks involving verbal memory or visual-motor coordination, ZOL impaired performance, whereas the 2 doses of ALM were no different than PBO. For tasks involving higher order executive function, ZOL produced impairment in processing speed and inhibitory control, whereas the 2 doses of ALM were no different than PBO. Performance decrements for ALM were less than ZOL but greater than PBO for some reaction time measures.
CONCLUSION


The data provide support for the hypothesis that hypocretin receptor (Hcrt) antagonists produce less functional impairment than a benzodiazepine receptor agonist (BzRA). These observations are particularly relevant to patients treated with sedative-hypnotics who are at elevated risk for falls and other untoward events during the intended hours for sleep.",2020,"For tasks involving higher order executive function, ZOL produced impairment in processing speed and inhibitory control, whereas the 2 doses of ALM were no different than PBO.","['human subjects', 'Healthy, young adult, unmedicated male and female subjects']","['ALM', 'placebo', 'hypocretin receptor antagonist almorexant (ALM', 'Zolpidem and Placebo', 'ZOL']","['Performance decrements for ALM', 'subjective sleepiness', 'acute cognitive impairment']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1871407', 'cui_str': 'almorexant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1113688', 'cui_str': 'Orexin'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0078839', 'cui_str': 'zolpidem'}]","[{'cui': 'C1871407', 'cui_str': 'almorexant'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]",,0.0357918,"For tasks involving higher order executive function, ZOL produced impairment in processing speed and inhibitory control, whereas the 2 doses of ALM were no different than PBO.","[{'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Neylan', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Richards', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Metzler', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Ruoff', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Varbel', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Aoife', 'Initials': 'A', 'LastName': ""O'Donovan"", 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Sivasubramanian', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Motraghi', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hlavin', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Batki', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sabra S', 'Initials': 'SS', 'LastName': 'Inslicht', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Samuelson', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Morairty', 'Affiliation': 'Center for Neuroscience, Biosciences Division, SRI International, Menlo Park, CA, USA.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Kilduff', 'Affiliation': 'Center for Neuroscience, Biosciences Division, SRI International, Menlo Park, CA, USA.'}]",Sleep,['10.1093/sleep/zsaa080']
32,32363926,Using Low-Calorie Orange Juice as a Dietary Alternative to Alkali Therapy.,"Purpose:  The pursuit of a dietary source to increase urine pH and citrate in stone formers has been ongoing for >30 years. Early evidence showed that orange juice (OJ) contains alkali and citrate, but high sugar and ascorbic acid content limited the use of OJ as a viable daily source of alkali. Recently, novel low-calorie OJs have emerged and could potentially be a better option.  Methods:  Beverages with high concentrations of alkali citrate and malate were identified using ion chromatography. Two low-calorie OJ beverages, in addition to crystal light lemonade beverage (CLLB), were chosen. Healthy volunteers (5 men, 5 women) drank 1 L of OJ or CLLB with 1 L water daily for 7 days, and then completed a 24-hour urinalysis. A washout week was instituted between trial weeks. The study design is a prospective randomized crossover control trial. A paired analysis using comparison of means was used to evaluate low-calorie OJ and CLLB. Volunteers had no prior history of kidney stones and maintained a journal with beverage compliance, side effect (SE), and dietary consumption data.  Results:  Tropicana 50 (TRP50), Kroger low-calorie OJ (KLCO), and CLLB were found to have a total alkali content of 56.60, 47.9, and 17.3 mEq/L, respectively, based on ion chromatography. Consumption of all three beverages raised urinary citrate (116.6 [-118 to 373, 177.9 [-3 to 359], 155.6 [-4 to 237] ▵mg/day 95% confidence interval) and urinary pH (0.25 [0.08-0.53], 0.74 [0.41-1.07  p  < 0.05], 0.25 [0.25-0.64]), respectively, compared with water phase. Based on journal entries by volunteers, TRP50 had the most SEs (90% participants) felt to be a result of the artificial sweetener (Stevia ® ).  Conclusion:  Low-calorie OJs, and to a lesser extent CLLB, have alkali and citrate based on ion chromatography. Daily consumption by healthy volunteers of KLCO can raise urinary pH.",2020,"Based on volunteer journal entries , TRP50 had the most side effects (90% participants) felt to be a result of the artificial sweetener (Stevia ®).
","['Tropicana 50 (TRP50', 'Volunteers had no prior history of kidney stones and maintained a journal with beverage compliance, side effect, and dietary consumption data', 'Healthy volunteers (5 men, 5 women) drank 1L of OJ or CLLB with 1L water daily for 7 days and then completed a 24-hour urinalysis', 'healthy volunteers of', 'Beverages with high concentrations of alkali citrate and malate were identified using ion chromatography']","['orange juice (OJ', 'Low-calorie Orange Juice', 'KLCO']","['urinary pH', 'Kroger low calorie OJ (KLCO) and CLLB']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1998388', 'cui_str': 'History of calculus of kidney'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C0024546', 'cui_str': 'Malates'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0008550', 'cui_str': 'Chromatography'}]","[{'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}]",2.0,0.028547,"Based on volunteer journal entries , TRP50 had the most side effects (90% participants) felt to be a result of the artificial sweetener (Stevia ®).
","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Large', 'Affiliation': 'From Indiana University Department of Urology and Litholink Corporation, Laboratory Corporation of America Holdings, Indianapolis, Indiana, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'From Indiana University Department of Urology and Litholink Corporation, Laboratory Corporation of America Holdings, Indianapolis, Indiana, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Asplin', 'Affiliation': 'From Indiana University Department of Urology and Litholink Corporation, Laboratory Corporation of America Holdings, Indianapolis, Indiana, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Krambeck', 'Affiliation': 'From Indiana University Department of Urology and Litholink Corporation, Laboratory Corporation of America Holdings, Indianapolis, Indiana, USA.'}]",Journal of endourology,['10.1089/end.2020.0031']
33,32359940,The effect of physical fatigue on tackling technique in Rugby Union.,"OBJECTIVES


To measure the change in tackling technique of rugby union players following an acute bout of physically fatiguing exercise.
DESIGN


Randomised cross-over study design with a physical fatigue condition and no-physical fatigue condition (control).
METHODS


Nineteen male amateur club rugby union players (n=19) and a total of 887 tackles were analysed. During each condition, each player performed four sets of six tackles (three dominant and three non-dominant shoulder) on a contact simulator. Between each set of tackles in the physical fatigue condition, players performed the prolonged high-intensity intermittent running ability test. Using video, player's tackling proficiency for each tackle was measured by awarding either one point or zero points depending on whether a particular technique was performed or not. The sum of these points represents player's tackling proficiency (score out of 9, measured in arbitrary units).
RESULTS


In the non-dominant shoulder, a difference between fatigue and control was found at set two (Fatigue 7.3 [7.1-7.6] AU vs. Control 7.6 [7.4-7.9] AU, p=0.06, ES=0.3 small) and set three (Fatigue 7.3 [7.0-7.5] AU vs. Control 7.7 [7.5-7.9] AU, p=0.006, ES=0.5 small). During the control condition, tackling proficiency scores improved from baseline for non-dominant tackles (Baseline 7.4 [7.2-7.6] AU, vs Set two 7.6 [7.4-7.9] AU, p=0.08 ES=0.3 small; vs Set three 7.7 [7.5-7.9] AU, p=0.05, ES=0.4 small).
CONCLUSIONS


In conclusion, this study shows that physical fatigue can potentially affect rugby union players' tackling technique. Therefore, players should develop technical capacity to resist the effects of physical fatigue during the tackle.",2020,"AU vs. Control 7.6 [7.4-7.9] AU, p=0.06, ES=0.3 small) and set three (Fatigue 7.3 [7.0-7.5]","['Rugby Union', 'rugby union players following an acute bout of physically fatiguing exercise', 'Nineteen male amateur club rugby union players (n=19) and a total of 887 tackles were analysed']",['physical fatigue condition and no-physical fatigue condition (control'],['tackling proficiency scores'],"[{'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}]",887.0,0.0268271,"AU vs. Control 7.6 [7.4-7.9] AU, p=0.06, ES=0.3 small) and set three (Fatigue 7.3 [7.0-7.5]","[{'ForeName': 'Demi', 'Initials': 'D', 'LastName': 'Davidow', 'Affiliation': 'University of Cape Town, Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Science, South Africa. Electronic address: DVDDEM001@myuct.ac.za.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Redman', 'Affiliation': 'University of Cape Town, Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Science, South Africa.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Lambert', 'Affiliation': 'University of Cape Town, Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Science, South Africa; VU University Medical Center, Department of Public & Occupational Health and the EMGO Institute Health and Care Research, Netherlands.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Burger', 'Affiliation': 'University of Cape Town, Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Science, South Africa.'}, {'ForeName': 'Mitchel', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': 'University of Newcastle, Exercise and Sports Science, Faculty of Science, Australia; University of Newcastle, Priority Research Centre for Physical Activity and Nutrition, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Jones', 'Affiliation': 'University of Cape Town, Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Science, South Africa; Leeds Beckett University, Carnegie Applied Rugby Research (CARR) Centre, Institute of Sport, Physical Activity and Health, UK; England Performance Unit, The Rugby Football League, UK; Leeds Rhinos Rugby League Club, UK; School of Science and Technology, University of New England, Australia.'}, {'ForeName': 'Sharief', 'Initials': 'S', 'LastName': 'Hendricks', 'Affiliation': 'University of Cape Town, Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Science, South Africa; Leeds Beckett University, Carnegie Applied Rugby Research (CARR) Centre, Institute of Sport, Physical Activity and Health, UK.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.04.005']
34,32369630,In situ decompression vs conservative treatment for mild ulnar neuropathy at the elbow.,"INTRODUCTION


The best treatment strategy for mild ulnar neuropathy at the elbow (UNE) is not known, due to lack of trials comparing surgery vs conservative treatment.
METHODS


We recruited patients with clinical symptoms and signs of mild UNE and an electrophysiologically or sonographically confirmed diagnosis. Patients were randomly allocated to either in situ decompression or conservative treatment. The primary outcome was the proportion of patients with subjective symptom improvement at short-term (3 months) and long-term (6-12 months) follow-up.
RESULTS


One hundred seventeen patients were included: 56 and 61 patients were allocated to surgery and conservative treatment, respectively. A larger proportion of surgically treated patients showed improvement at short-term follow-up (85% vs 50%; odds ratio, 5.6; P < .001), but no differences were observed at long-term follow-up.
DISCUSSION


In situ decompression for mild UNE may result in faster relief of symptoms when compared with conservative treatment, but at long-term follow-up no differences were observed.",2020,"A larger proportion of surgically treated patients showed improvement at short-term follow-up (85% versus 50%, odds ratio 5.6, p <.001), but no differences were observed at long-term follow-up.
","['Patients with clinical symptoms and signs of mild UNE and an electrophysiologically or sonographically confirmed diagnosis were recruited', '117 patients were included: 56 and 61 patients']","['situ decompression or conservative treatment', 'situ decompression versus conservative treatment']","['relief of symptoms', 'proportion of patients with subjective symptom improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0154743', 'cui_str': 'Ulnar neuropathy'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",117.0,0.0474031,"A larger proportion of surgically treated patients showed improvement at short-term follow-up (85% versus 50%, odds ratio 5.6, p <.001), but no differences were observed at long-term follow-up.
","[{'ForeName': 'Sander M', 'Initials': 'SM', 'LastName': 'Pompe', 'Affiliation': 'Department of Neurology, Zuyderland Medisch Centrum, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Tobien', 'Initials': 'T', 'LastName': 'Schreuder', 'Affiliation': 'Department of Neurology, Zuyderland Medisch Centrum, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Laurien L', 'Initials': 'LL', 'LastName': 'Teunissen', 'Affiliation': 'Department of Neurology, St. Antonius Ziekenhuis Nieuwegein, The Netherlands.'}, {'ForeName': 'Leo H', 'Initials': 'LH', 'LastName': 'Visser', 'Affiliation': 'Department of Neurology, Elisabeth TweeSteden Ziekenhuis, Tilburg, The Netherlands.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Beekman', 'Affiliation': 'Department of Neurology, Zuyderland Medisch Centrum, Sittard-Geleen, The Netherlands.'}]",Muscle & nerve,['10.1002/mus.26912']
35,32360042,Survival probability of zirconia-reinforced lithium silicate ceramic: Effect of surface condition and fatigue test load profile.,"OBJECTIVES


The present investigation evaluated the step stress accelerated test (SSALT) load profiles on the survival probability of a glass ceramic under two surface conditions (polished or roughened).
METHODS


Suprinity-ZLS blocks (Vita Zhanfabrik) were shaped into cylinders, cut in a sawing machine, and crystalized according to the manufacturer's instructions. 60 discs were obtained (Ø=12mm, thickness=1.2mm) and randomly assigned into two surface conditions: ""p"" polished surface (400-1200-grit SiC papers), and ""r"" roughened surface (200-grit SiC papers). Profilometry was performed in all discs to evaluate average surface roughness prior to flexural fatigue strength testing. 3 discs of each group were submitted to biaxial flexural strength in an universal testing machine (0.5mm/min) and the mean load to failure (N) was calculated to determine SSALT profiles. 27 specimens per surface condition were assigned into three profiles - Mild (n=9), Moderate (n=9), and Aggressive (n=9), and submitted to the fatigue test (60-320N, 140,000 cycles at 1.4Hz). The results were analyzed using the Kaplan-Meier and Wilcoxon tests (5%), 2-way ANOVA and Tukey test (α=5%).
RESULTS


Kaplan-Meier and generalized Wilcoxon showed (P=0.002) that polished groups showed higher survival probability than roughened condition (P<0.05). A rough internal surface impacted deleteriously on the fatigue strength and reliability of ZLS ceramic. Both surface conditions were more sensitive to the aggressive profile than the other profiles, even worst for the roughened group. Regardless the load profile, 0% survival probability was observed at 384MPa for polished condition. While for roughened, aggressive tested specimens did not survived 147MPa followed by moderate at 312MPa and mild at 384MPa. The failure modes showed fracture marks originating from superficial grooves for both surface conditions.
SIGNIFICANCE


Polished specimens are sensitive to the load profile variation, confirming the effect of surface morphology on the fatigue results.",2020,Wilcoxon showed (P=0.002) that polished groups showed higher survival probability than roughened condition (P<0.05).,"['Suprinity-ZLS blocks (Vita Zhanfabrik', '27 specimens per surface condition were assigned into three profiles - Mild (n=9), Moderate (n=9), and Aggressive (n=9']","['Wilcoxon', 'zirconia-reinforced lithium silicate ceramic']","['fatigue strength and reliability of ZLS ceramic', 'Survival probability', 'Kaplan-Meier and Wilcoxon tests', 'survival probability', 'biaxial flexural strength']","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0373745', 'cui_str': 'Vitamin A measurement'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}]","[{'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0086983', 'cui_str': 'Silicate salt'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4704755', 'cui_str': 'Fracture Strength'}]",60.0,0.0177578,Wilcoxon showed (P=0.002) that polished groups showed higher survival probability than roughened condition (P<0.05).,"[{'ForeName': 'Amanda Maria de Oliveira', 'Initials': 'AMO', 'LastName': 'Dal Piva', 'Affiliation': 'PhD Graduate Program in Restorative Dentistry, São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, SP, Brazil; Department of Dental Materials Science, Academic Centre for Dentistry Amsterdam (ACTA), Universiteit van Amsterdam and Vrije Universiteit, The Netherlands. Electronic address: amodalpiva@gmail.com.'}, {'ForeName': 'João Paulo Mendes', 'Initials': 'JPM', 'LastName': 'Tribst', 'Affiliation': 'PhD Graduate Program in Restorative Dentistry, São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, SP, Brazil; Department of Dental Materials Science, Academic Centre for Dentistry Amsterdam (ACTA), Universiteit van Amsterdam and Vrije Universiteit, The Netherlands. Electronic address: joao.tribst@unesp.br.'}, {'ForeName': 'Andressa Borin', 'Initials': 'AB', 'LastName': 'Venturini', 'Affiliation': 'PhD Graduate Program in Oral Science (Prosthodontics Unit), Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: andressa.venturini@hotmail.com.'}, {'ForeName': 'Lilian Costa', 'Initials': 'LC', 'LastName': 'Anami', 'Affiliation': 'Department of Prosthodontics, Santo Amaro University, São Paulo, Brazil. Electronic address: lianami@gmail.com.'}, {'ForeName': 'Estevam Augusto', 'Initials': 'EA', 'LastName': 'Bonfante', 'Affiliation': 'Department of Prosthodontics and Periodontology, University of São Paulo, Bauru School of Dentistry, Brazil. Electronic address: estevamab@gmail.com.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Bottino', 'Affiliation': 'PhD Graduate Program in Restorative Dentistry, São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, SP, Brazil. Electronic address: mmbottino@uol.com.br.'}, {'ForeName': 'Cornelis Johannes', 'Initials': 'CJ', 'LastName': 'Kleverlaan', 'Affiliation': 'Department of Dental Materials Science, Academic Centre for Dentistry Amsterdam (ACTA), Universiteit van Amsterdam and Vrije Universiteit, The Netherlands. Electronic address: c.kleverlaan@acta.nl.'}]",Dental materials : official publication of the Academy of Dental Materials,['10.1016/j.dental.2020.03.029']
36,32369295,"The Effect of Diclofenac on Bleeding, Platelet Function, and Consumption of Opioids Following Cardiac Surgery.","OBJECTIVE


To establish whether the use of diclofenac reduces the administration of opioids and how it affects bleeding and platelet function after the coronary artery bypass grafting (CABG) surgery with use of cardiopulmonary bypass (CPB).
METHODS


A total of 72 patients undergoing CABG surgery were included in this retrospective randomized study and divided into two groups (34 patients received diclofenac and the control group of 38 patients did not). For postoperative analgesia, both groups were prescribed opioids (piritramide). The primary endpoint was to establish the consumption of opioids. The secondary endpoint was to determine bleeding and the function of platelets 20 hours after the surgery.
RESULTS


The consumption of piritramide (diclofenac group 26±8 mg vs. control group 28±8 mg), the blood loss, and the function of platelets did not significantly differ between the groups within 20 hours after surgery. C-reactive protein (CRP) was statistically significantly lower in the diclofenac group than in the control group (33±15 mg/L vs. 46±22 mg/L, respectively, P<0.05).
CONCLUSION


The study concluded that patients administered with diclofenac after the heart surgery did not consume less opioid analgesics and did not exhibit less symptoms linked to the consumption of opioids. Diclofenac in clinically administered doses does not interfere with the function of platelets and does not cause increased bleeding. Lower CRP in the diclofenac group may indicate a reduced inflammatory response after CPB. Therefore, diclofenac could be safe for use in patients undergoing CABG surgery but its value in reducing opioid consumption should be questioned.",2020,"The consumption of piritramide (diclofenac group 26±8 mg vs. control group 28±8 mg), the blood loss, and the function of platelets did not significantly differ between the groups within 20 hours after surgery.","['72 patients undergoing CABG surgery', 'patients undergoing CABG surgery']","['piritramide (diclofenac', 'opioids (piritramide', 'Diclofenac', 'diclofenac', 'coronary artery bypass grafting (CABG) surgery with use of cardiopulmonary bypass (CPB']","['C-reactive protein (CRP', 'consumption of opioids', 'blood loss, and the function of platelets', 'Bleeding, Platelet Function, and Consumption of Opioids', 'bleeding', 'opioid analgesics', 'bleeding and the function of platelets 20 hours after the surgery', 'inflammatory response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0031982', 'cui_str': 'Pirinitramide'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",72.0,0.0260099,"The consumption of piritramide (diclofenac group 26±8 mg vs. control group 28±8 mg), the blood loss, and the function of platelets did not significantly differ between the groups within 20 hours after surgery.","[{'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Osojnik', 'Affiliation': 'University Medical Centre Maribor Intensive Care and Pain Management Department of Anaesthesiology Maribor Slovenia Department of Anaesthesiology, Intensive Care and Pain Management, University Medical Centre Maribor, Maribor, Slovenia.'}, {'ForeName': 'Mirt', 'Initials': 'M', 'LastName': 'Kamenik', 'Affiliation': 'University Medical Centre Maribor Intensive Care and Pain Management Department of Anaesthesiology Maribor Slovenia Department of Anaesthesiology, Intensive Care and Pain Management, University Medical Centre Maribor, Maribor, Slovenia.'}]",Brazilian journal of cardiovascular surgery,['10.21470/1678-9741-2019-0283']
37,32369298,Effect of Papaverine on Left Internal Mammary Artery Flow: Topical Spraying versus Perivascular Injection Method.,"OBJECTIVE


To analyze two techniques of papaverine application, topical spray on the harvested left internal mammary artery (LIMA) and perivascular injection, to find out their ability to improve LIMA flow.
METHODS


Forty patients were randomized into two groups. In Group 1, papaverine was sprayed on the harvested pedunculated LIMA. In Group 2, papaverine was delivered into the perivascular plane. Drug dosage was the same for both groups. LIMA flow was measured 20 minutes after applying papaverine. Blood flow was recorded for 20 seconds and flow per minute was calculated. The systemic mean pressures were maintained at 70 mmHg during blood collection. The data collected was statistically evaluated and interpreted.
RESULTS


The LIMA blood flow before papaverine application in the Group 1 was 51.9±13.40 ml/min and in Group 2 it was 55.1±15.70 ml/min. Statistically, LIMA flows were identical in both groups before papaverine application. The LIMA blood flow, post papaverine application, in Group 1 was 87.20±13.46 ml/min and in Group 2 it was 104.7±20.19 ml/min. The Group 2 flows were statistically higher than Group 1 flows.
CONCLUSION


Papaverine delivery to LIMA by the perivascular injection method provided statistically significant higher flows when compared to the topical spray method. Hence, the perivascular delivery of papaverine is more efficient than the spray method in improving LIMA blood flow.",2020,"The LIMA blood flow, post papaverine application, in Group 1 was 87.20±13.46 ml/min and in Group 2 it was",['Forty patients'],"['Papaverine', 'papaverine', 'papaverine application, topical spray']","['Blood flow', 'systemic mean pressures', 'Left Internal Mammary Artery Flow', 'LIMA blood flow', 'LIMA flows', 'LIMA flow']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030350', 'cui_str': 'Papaverine'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C1154185', 'cui_str': 'Topical Spray'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0445074', 'cui_str': 'Mean pressure'}, {'cui': 'C0447054', 'cui_str': 'Left internal mammary artery'}]",40.0,0.0141348,"The LIMA blood flow, post papaverine application, in Group 1 was 87.20±13.46 ml/min and in Group 2 it was","[{'ForeName': 'Girish', 'Initials': 'G', 'LastName': 'Gowda', 'Affiliation': 'Sri Jayadeva Institute of Cardiovascular Sciences and Research Department of Cardiothoracic and Vascular Surgery Bangalore Karnataka India Department of Cardiothoracic and Vascular Surgery, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore, Karnataka, India.'}, {'ForeName': 'Jayanth', 'Initials': 'J', 'LastName': 'Kumar', 'Affiliation': 'Sri Jayadeva Institute of Cardiovascular Sciences and Research Department of Cardiothoracic and Vascular Surgery Bangalore Karnataka India Department of Cardiothoracic and Vascular Surgery, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore, Karnataka, India.'}, {'ForeName': 'Veeresh', 'Initials': 'V', 'LastName': 'G S', 'Affiliation': 'Sri Jayadeva Institute of Cardiovascular Sciences and Research Department of Cardiothoracic and Vascular Surgery Bangalore Karnataka India Department of Cardiothoracic and Vascular Surgery, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore, Karnataka, India.'}, {'ForeName': 'Anand Kuriyan', 'Initials': 'AK', 'LastName': 'Mathew', 'Affiliation': 'Sri Jayadeva Institute of Cardiovascular Sciences and Research Department of Cardiothoracic and Vascular Surgery Bangalore Karnataka India Department of Cardiothoracic and Vascular Surgery, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore, Karnataka, India.'}, {'ForeName': 'Manjunath Cholenahally', 'Initials': 'MC', 'LastName': 'Nanjappa', 'Affiliation': 'Sri Jayadeva Institute of Cardiovascular Sciences and Research Department of Cardiothoracic and Vascular Surgery Bangalore Karnataka India Department of Cardiothoracic and Vascular Surgery, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore, Karnataka, India.'}]",Brazilian journal of cardiovascular surgery,['10.21470/1678-9741-2019-0126']
38,32370612,Effectiveness of a crossover prosthetic foot in active children with a congenital lower limb deficiency: an explorative study.,"BACKGROUND


Children with lower limb prostheses cannot always keep up with their peers during active play. A pediatric crossover foot may be a promising prosthetic alternative for children engaging in high-intensity movements necessary for active play.
OBJECTIVES


To compare children's walking performance, running performance, experienced competence, and cosmesis using their prescribed prosthesis compared with the crossover foot.
STUDY DESIGN


Pretest-posttest study.
METHODS


Children with lower limb amputation or deficiency were recruited. Measurements were taken at baseline with the prescribed prosthesis and 6 weeks later with the crossover foot. Walking speed, energy cost of walking, anaerobic muscle power, stair climbing speed, ankle power, and cosmesis were evaluated.
RESULTS


Four children participated in the study. Two children had increased walking speed with the same energy cost, one child had decreased speed with increased energy cost, and one child had the same speed with decreased energy cost. Muscle power increased for three of the four children and ankle power increased for all children while using the crossover foot compared to the prescribed prosthesis. Two children reported knee pain or feeling excessive knee flexion when running with the crossover foot. One child reported negative feelings toward cosmesis of the crossover foot.
CONCLUSIONS


This study suggests crossover foot may benefit active children by improving walking and running performance, and decreasing energy cost. However, knee pain reports or negative feelings toward the atypical design suggest the crossover foot may not be ideal for every child. Further research is needed to determine which pediatric users would benefit from this type of prosthetic foot.
CLINICAL RELEVANCE


Children with lower limb deficiencies are active prosthetic users who often switch between low- and high-intensity movements in their daily activities. Therefore, they might benefit from a crossover prosthetic design. The preliminary findings of this study suggest the crossover foot (XF) may be a promising foot for active children.",2020,Muscle power increased for three of the four children and ankle power increased for all children while using the crossover foot compared to the prescribed prosthesis.,"['Children with lower limb amputation or deficiency were recruited', 'active children with a congenital lower limb deficiency', 'Children with lower limb deficiencies', 'Children with lower limb prostheses', 'Four children participated in the study']",[],"['Muscle power', 'energy cost', 'Walking speed, energy cost of walking, anaerobic muscle power, stair climbing speed, ankle power, and cosmesis', 'ankle power', 'knee pain or feeling excessive knee flexion', 'walking speed', ""children's walking performance, running performance, experienced competence, and cosmesis""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0524491', 'cui_str': 'Leg prosthesis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",2.0,0.0342065,Muscle power increased for three of the four children and ankle power increased for all children while using the crossover foot compared to the prescribed prosthesis.,"[{'ForeName': 'Floor Jacoba Marie-Georgette', 'Initials': 'FJM', 'LastName': 'Verheul', 'Affiliation': 'Pediatric Department, De Hoogstraat Revalidatie, Utrecht, The Netherlands.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Verschuren', 'Affiliation': 'Center of Excellence for Rehabilitation Medicine, UMC Utrecht Brain Center, University Medical Center Utrecht, The Netherlands.'}, {'ForeName': 'Maremka', 'Initials': 'M', 'LastName': 'Zwinkels', 'Affiliation': 'Center of Excellence for Rehabilitation Medicine, UMC Utrecht Brain Center, University Medical Center Utrecht, The Netherlands.'}, {'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Herwegh', 'Affiliation': 'Center of Excellence for Rehabilitation Medicine, UMC Utrecht Brain Center, University Medical Center Utrecht, The Netherlands.'}, {'ForeName': 'Anka', 'Initials': 'A', 'LastName': 'Michielsen', 'Affiliation': 'Pediatric Department, De Hoogstraat Revalidatie, Utrecht, The Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'de Haan', 'Affiliation': 'Pediatric Department, De Hoogstraat Revalidatie, Utrecht, The Netherlands.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'van Wijk', 'Affiliation': 'Pediatric Department, De Hoogstraat Revalidatie, Utrecht, The Netherlands.'}]",Prosthetics and orthotics international,['10.1177/0309364620912063']
39,32371830,Effects of intra-operative positive end-expiratory pressure setting guided by oesophageal pressure measurement on oxygenation and respiratory mechanics during laparoscopic gynaecological surgery: A randomised controlled trial.,"BACKGROUND


The creation of pneumoperitoneum during laparoscopic surgery can lead to adverse effects on the respiratory system. Positive end-expiratory pressure (PEEP) plays an important role in mechanical ventilation during laparoscopic surgery.
OBJECTIVE


To evaluate whether PEEP setting guided by oesophageal pressure (Poeso) measurement would affect oxygenation and respiratory mechanics during laparoscopic gynaecological surgery.
DESIGN


A randomised controlled study.
SETTING


A single-centre trial from March 2018 to June 2018.
PATIENTS


Forty-four adult patients undergoing laparoscopic gynaecological surgery with anticipated duration of surgery more than 2 h.
INTERVENTION


PEEP set according to Poeso measurement (intervention group) versus PEEP constantly set at 5 cmH2O (control group).
MAIN OUTCOME MEASURES


Gas exchange and respiratory mechanics after induction and intubation (T0) and at 15 and 60 min after initiation of pneumoperitoneum (T1 and T2, respectively).
RESULTS


PEEP during pneumoperitoneum was significantly higher in the intervention group than in the control group (T1, 12.5 ± 1.9 vs. 5.0 ± 0.0 cmH2O and T2, 12.4 ± 1.9 vs. 5.0 ± 0.0 cmH2O, both P < 0.001). Partial pressures of oxygen decreased significantly from baseline during pneumoperitoneum in the control group but not in the intervention group. Nevertheless, the changes in partial pressures of oxygen did not differ between groups. Compliance of the respiratory system (CRS) significantly decreased and driving pressure significantly increased during pneumoperitoneum in both groups. However, the changes in CRS and driving pressure were significantly less in the intervention group. Transpulmonary pressure during expiration was maintained in the intervention group while it decreased significantly in the control group.
CONCLUSION


PEEP setting guided by Poeso measurement showed no beneficial effects in terms of oxygenation but respiratory mechanics were better during laparoscopic gynaecological surgery.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03256396.",2020,"PEEP setting guided by Poeso measurement showed no beneficial effects in terms of oxygenation but respiratory mechanics were better during laparoscopic gynaecological surgery.
","['laparoscopic gynaecological surgery', 'A single-centre trial from March 2018 to June 2018', 'Forty-four adult patients undergoing laparoscopic gynaecological surgery with anticipated duration of surgery more than 2\u200ah']","['intra-operative positive end-expiratory pressure setting guided by oesophageal pressure measurement', 'PEEP set according to Poeso measurement (intervention group) versus PEEP constantly set at 5\u200acmH2O (control group', 'PEEP setting guided by oesophageal pressure (Poeso) measurement']","['oxygenation and respiratory mechanics', 'CRS and driving pressure', 'driving pressure', 'partial pressures of oxygen', 'Partial pressures of oxygen', 'Positive end-expiratory pressure (PEEP', 'Gas exchange and respiratory mechanics after induction and intubation (T0) and at 15 and 60\u200amin after initiation of pneumoperitoneum (T1 and T2, respectively', 'Transpulmonary pressure during expiration']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0807495', 'cui_str': 'Positive end expiratory pressure setting'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0232531', 'cui_str': 'Esophageal pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}]",44.0,0.183262,"PEEP setting guided by Poeso measurement showed no beneficial effects in terms of oxygenation but respiratory mechanics were better during laparoscopic gynaecological surgery.
","[{'ForeName': 'Annop', 'Initials': 'A', 'LastName': 'Piriyapatsom', 'Affiliation': 'From the Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand (AP, SP).'}, {'ForeName': 'Sanchai', 'Initials': 'S', 'LastName': 'Phetkampang', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001204']
40,32374395,Association of Neurodevelopmental Outcomes With Environmental Exposure to Cyclohexanone During Neonatal Congenital Cardiac Operations: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Cyclohexanone is an industrial solvent used as a coupling agent in medical plastics. Perioperative exposure to cyclohexanone could play a role in lower scores on measures of neurodevelopmental outcomes after neonatal cardiac operations.
Objective


To examine the presence and association of serum cyclohexanone level with neonatal cardiac operations and neurodevelopmental outcomes.
Design, Setting, and Participants


This ad hoc secondary analysis used data from the Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass randomized clinical trial. The cohort included neonates younger than 31 days and with at least 37 weeks postgestational age at surgical treatment who were enrolled at a single center between June 1, 2012, and October 31, 2016, and who had completed a neurodevelopmental assessment at age 12 months. Data were analyzed from July 8 to August 20, 2019.
Exposures


Serum cyclohexanone and its metabolites were measured preoperatively (prior to skin incision), postoperatively (immediately after the surgical procedure was completed), and 12 hours postoperatively. Cyclohexanone and the molar sum of its metabolites were examined at each point and as a geometric mean of all 3 points.
Main Outcomes and Measures


Neurodevelopment was assessed at age 12 months with the Bayley Scales of Infant and Toddler Development III, assessing cognitive, language, and motor function composite scores standardized to a population mean (SD) of 100 (15). Linear regression models were used to determine covariate-adjusted differences in 12-month cognitive, language, and motor composite scores per interquartile range increase in cyclohexanone level or summed metabolite molar concentrations.
Results


Among 85 included neonates, mean (SD) age at surgical treatment was 9.7 (5.3) days, 49 (58%) were boys, and 54 (64%) underwent corrective repair. Mean (SD) Bayley Scales of Infant and Toddler Development III composite scores were 108.2 (12.2) for cognitive function, 104.7 (11.0) for language function, and 94.7 (15.7) for motor function. Median (interquartile range) cyclohexanone levels increased approximately 3-fold from immediately prior to surgical treatment to immediately after surgical treatment (572 [389-974] vs 1744 [1469-2291] μg/L; P = .001). In adjusted analyses, higher geometric mean cyclohexanone levels were associated with significantly lower composite scores for cognitive (-4.23; 95% CI, -7.39 to -1.06; P = .01) and language (-3.65; 95% CI, -6.41 to -0.88; P = .01) function. The difference in composite scores for motor function among infants with higher geometric mean cyclohexanone levels was not statistically significant(-3.93, 95% CI: -8.19 to 0.33, P = .07).
Conclusions and Relevance


The findings of this secondary analysis of a randomized clinical trial suggest that infants who underwent neonatal cardiac surgical treatment with cardiopulmonary bypass had substantial cyclohexanone levels, which were associated with adverse neurodevelopmental function at age 12 months.
Trial Registration


ClinicalTrials.gov identifier: NCT01579513.",2020,"The difference in composite scores for motor function among infants with higher geometric mean cyclohexanone levels was not statistically significant(-3.93, 95% CI: -8.19 to 0.33, P = .07).
","['Neonates Undergoing Cardiopulmonary Bypass randomized clinical trial', 'cohort included neonates younger than 31 days and with at least 37 weeks postgestational age at surgical treatment who were enrolled at a single center between June 1, 2012, and October 31, 2016, and who had completed a neurodevelopmental assessment at age 12 months', '85 included neonates', 'Neonatal Congenital Cardiac Operations']","['cyclohexanone', 'neonatal cardiac surgical treatment with cardiopulmonary bypass', 'Environmental Exposure to Cyclohexanone', 'Cyclohexanone', 'Corticosteroid Therapy']","['adverse neurodevelopmental function', 'Median (interquartile range) cyclohexanone levels', 'composite scores for motor function', 'Mean (SD) Bayley Scales of Infant and Toddler Development III composite scores', 'neurodevelopmental outcomes', 'Exposures\n\n\nSerum cyclohexanone and its metabolites', 'Bayley Scales of Infant and Toddler Development III, assessing cognitive, language, and motor function composite scores standardized to a population mean (SD) of 100 (15', 'geometric mean cyclohexanone levels']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0010571', 'cui_str': 'Cyclohexanones'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0014412', 'cui_str': 'Environmental exposure'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0010571', 'cui_str': 'Cyclohexanones'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1704407', 'cui_str': '100'}]",,0.168514,"The difference in composite scores for motor function among infants with higher geometric mean cyclohexanone levels was not statistically significant(-3.93, 95% CI: -8.19 to 0.33, P = .07).
","[{'ForeName': 'Allen D', 'Initials': 'AD', 'LastName': 'Everett', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Jessie P', 'Initials': 'JP', 'LastName': 'Buckley', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Department of Environmental Health and Engineering, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Ellis', 'Affiliation': ""Molecular Determinants Core, Johns Hopkins All Children's Hospital, St Petersburg, Florida.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Graham', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Griffiths', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Melania', 'Initials': 'M', 'LastName': 'Bembea', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Graham', 'Affiliation': 'Department of Pediatrics, Division of Cardiology, Medical University of South Carolina; Charleston.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.4070']
41,32372387,Comparing the Potential for Irritation of a Ceramide-Based Moisturizer with a Urea-Based Moisturizer for Pediatric Atopic Dermatitis.,"INTRODUCTION


Moisturizers are one of the mainstays of the topical treatment of atopic dermatitis (AD). One of the adverse effects of moisturizers is skin irritation, especially on excoriated AD skin. We compared the potential for irritation of two commercially available moisturizer products for the treatment of AD: a ceramide-based moisturizer (Ceradan ®  Cream; Hyphens Pharma Pte Ltd, Singapore) and a urea 5% moisturizer (Aqurea Lite Cream; ICA Pharma Pte Ltd, Singapore).
METHODS


We performed a prospective single-blind randomized controlled study recruiting AD patients aged between 8 and 16 years with symmetrical or near symmetrical scratch marks (excoriations) of at least grade 2 to 3 severity score, according to the Eczema Area and Severity Index (EASI), over bilateral antecubital fossae. Subjects were randomized to receive the ceramide-based moisturizer to either the left or right antecubital fossa or urea 5% cream to the other antecubital fossa. Subjects were asked to grade the immediate skin irritation of both creams on a standard visual analogue scale (VAS) and which cream they would prefer to use as a daily moisturizer. Primary outcome was the mean irritant score of each cream, and secondary outcome was the subjects' preference of either cream as their daily moisturizer.
RESULTS


A total of 42 participants were enrolled with a mean age of 11 years 5 months. The ceramide-based cream had a significantly lower mean VAS score (mean 0.69, SD = 1.63) for irritation compared with urea 5% cream (1.43, SD = 1.64) (p = 0.035). More participants also preferred the ceramide-based cream over urea 5% cream (62% versus 38%) as their daily moisturizer, but this did not reach statistical significance (p = 0.164).
CONCLUSIONS


A ceramide-based moisturizer may be considered as a suitable choice for children to minimize irritation from moisturizer treatment for AD.",2020,"The ceramide-based cream had a significantly lower mean VAS score (mean 0.69, SD = 1.63) for irritation compared with urea 5% cream (1.43, SD = 1.64) (p = 0.035).","['Pediatric Atopic Dermatitis', 'AD patients aged between 8 and 16\xa0years with symmetrical or near symmetrical scratch marks (excoriations) of at least grade 2 to 3 severity score, according to the Eczema Area and Severity Index (EASI), over bilateral antecubital fossae', '42 participants were enrolled with a mean age of 11\xa0years 5\xa0months']","['ceramide-based moisturizer to either the left or right antecubital fossa or urea 5% cream to the other antecubital fossa', 'Ceramide-Based Moisturizer with a Urea-Based Moisturizer']","['standard visual analogue scale (VAS', 'mean irritant score of each cream', ""subjects' preference of either cream as their daily moisturizer"", 'mean VAS score']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1384489', 'cui_str': 'Scratch marks'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0446523', 'cui_str': 'Antecubital fossa (surface region)'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0022108', 'cui_str': 'Irritant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",42.0,0.0323502,"The ceramide-based cream had a significantly lower mean VAS score (mean 0.69, SD = 1.63) for irritation compared with urea 5% cream (1.43, SD = 1.64) (p = 0.035).","[{'ForeName': 'Valerie Pui Yoong', 'Initials': 'VPY', 'LastName': 'Ho', 'Affiliation': ""Dermatology Service, KK Women's and Children's Hospital, Singapore, Singapore. valerie.ho.p.y@singhealth.com.sg.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ma', 'Affiliation': ""Dermatology Service, KK Women's and Children's Hospital, Singapore, Singapore.""}, {'ForeName': 'Hui Min', 'Initials': 'HM', 'LastName': 'Liew', 'Affiliation': ""Dermatology Service, KK Women's and Children's Hospital, Singapore, Singapore.""}, {'ForeName': 'Michelle Si Ying', 'Initials': 'MSY', 'LastName': 'Ng', 'Affiliation': ""Dermatology Service, KK Women's and Children's Hospital, Singapore, Singapore.""}, {'ForeName': 'Mark Jean Aan', 'Initials': 'MJA', 'LastName': 'Koh', 'Affiliation': ""Dermatology Service, KK Women's and Children's Hospital, Singapore, Singapore.""}]",Dermatology and therapy,['10.1007/s13555-020-00388-6']
42,32314374,The effects of using psychodrama on the psychological wellbeing of university students.,"PURPOSE


This study aims to investigate the effects of psychodrama group sessions on the psychological wellbeing of university students.
DESIGN AND METHODS


The study included a sample of 30 undergraduate students (divided into one intervention group and one control group). Data were collected using a Personal Information Form and the Psychological Wellbeing Scale.
FINDINGS


There was a statistically significant difference between the pretest and 12-month scores for participants in the psychodrama group within the ""Environmental Mastery"" dimension (P < .05).
PRACTICE IMPLICATIONS


Psychodrama group therapy can be used to improve psychological wellbeing levels among university students.",2020,"There was a statistically significant difference between the pretest and 12-month scores for participants in the psychodrama group within the ""Environmental Mastery"" dimension (P < .05).
","['university students', '30 undergraduate students']","['psychodrama', 'psychodrama group sessions']","['Environmental Mastery"" dimension', 'psychological wellbeing levels']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0033889', 'cui_str': 'Psychodrama'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",30.0,0.0163412,"There was a statistically significant difference between the pretest and 12-month scores for participants in the psychodrama group within the ""Environmental Mastery"" dimension (P < .05).
","[{'ForeName': 'Fadime', 'Initials': 'F', 'LastName': 'Kaya', 'Affiliation': 'Department of Mental Health and Psychiatric Nursing, Faculty of Health Sciences, Kafkas University, Kars, Turkey.'}, {'ForeName': 'Hülya', 'Initials': 'H', 'LastName': 'Deniz', 'Affiliation': 'Psychiatrist (Specialist), Istanbul, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12510']
43,32379333,Association of Individual-Level Factors With Visual Outcomes in Optic Neuritis: Secondary Analysis of a Randomized Clinical Trial.,"Importance


Using corticosteroids to treat acute demyelinating optic neuritis has been identified as an area for shared decision-making. However, no analysis exists to support personalized shared decision-making that considers long- and short-term treatment benefits.
Objective


To develop models of individual-level visual outcomes for patients with optic neuritis.
Design, Setting, and Participants


This secondary analysis of the Optic Neuritis Treatment Trial (ONTT), a randomized clinical trial, was performed at 14 academic eye centers and 1 large community eye center. Adults aged 18 to 46 years with incident acute unilateral optic neuritis within 8 days of vision loss onset were included. Data were collected from July 1988 to June 1991, downloaded on October 15, 2018, and analyzed from January 24, 2019, to February 20, 2020, using multivariable linear regression modeling.
Exposures


Intravenous corticosteroids vs placebo.
Main Outcomes and Measures


Visual acuity (VA) at 1 year. Secondary outcomes were 1-year contrast sensitivity (CS) and VA and CS at 15 and 30 days. Independent variables included age, sex, race, multiple sclerosis status, optic neuritis episodes in the fellow eye, vision symptoms (days), pain, optic disc swelling, viral illness, treatment group, and baseline VA or CS.
Results


Of the 455 participants, median age was 31.8 (interquartile range [IQR], 26.3-37.0) years; 350 (76.9%) were women; and 388 (85.3%) were white. For 410 participants (90.1%) with 1-year outcomes, median VA improved from 20/66 (IQR, 20/28-20/630) at enrollment to 20/17 (IQR, 20/14-20/21) at 1 year. Baseline VA was the primary variable associated with 1-year VA (regression coefficient, 0.056 [95% CI, 0.008-0.103]; P = .02) if baseline VA was better than count fingers (CF). At 15 days, baseline VA and treatment status were associated with VA in those participants with baseline VA better than CF (regression coefficient, 0.305 [95% CI, 0.231-0.380]; F = 9.42; P < .001). However, the difference of medians (20/18 [95% CI, 20/17-20/19] with intravenous corticosteroids vs 20/23 [95% CI, 20/21-20/26] with placebo) was small for the median VA (20/66) in the trial. Treatment was not associated with 15-day or 1-year VA in participants with baseline VA of CF or worse.
Conclusions and Relevance


In this study, long-term VA was associated with severity of baseline vision loss. Early benefits with intravenous corticosteroid treatment were limited to participants with baseline VA better than CF. However, the early, temporary benefit of intravenous corticosteroids is of questionable clinical significance and should be weighed against potential harms.",2020,"Treatment was not associated with 15-day or 1-year VA in participants with baseline VA of CF or worse.
","['14 academic eye centers and 1 large community eye center', '455 participants', ' median age was 31.8 (interquartile range [IQR], 26.3-37.0) years; 350 (76.9%) were women; and 388 (85.3%) were white', 'Adults aged 18 to 46 years with incident acute unilateral optic neuritis within 8 days of vision loss onset were included', 'Data were collected from July 1988 to June 1991, downloaded on October 15, 2018, and analyzed from January 24, 2019, to February 20, 2020, using multivariable linear regression modeling', 'patients with optic neuritis', 'Optic Neuritis']","['corticosteroids vs placebo', 'corticosteroids', 'intravenous corticosteroid', 'placebo']","['Measures\n\n\nVisual acuity (VA', '1-year contrast sensitivity (CS) and VA and CS', 'severity of baseline vision loss', 'fellow eye, vision symptoms (days), pain, optic disc swelling, viral illness', 'median VA']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517668', 'cui_str': '26.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0029134', 'cui_str': 'Optic neuritis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023733', 'cui_str': 'Linear Regression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0029127', 'cui_str': 'Optic disc structure'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.653426,"Treatment was not associated with 15-day or 1-year VA in participants with baseline VA of CF or worse.
","[{'ForeName': 'Lindsey B', 'Initials': 'LB', 'LastName': 'De Lott', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Burke', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Andrews', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Costello', 'Affiliation': 'Section of Ophthalmology, Department of Clinical Neurosciences and Surgery, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Wayne T', 'Initials': 'WT', 'LastName': 'Cornblath', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Trobe', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Kerber', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.4339']
44,32376080,Resting State Functional Connectivity and Outcomes of Psychotherapies for Late-Life Depression.,"BACKGROUND


Problem solving therapy (PST) and ""Engage,"" a reward-exposure"" based therapy, are important treatment options for late-life depression, given modest efficacy of antidepressants in this disorder. Abnormal function of the reward and default mode networks has been observed during depressive episodes. This study examined whether resting state functional connectivity (rsFC) of reward and DMN circuitries is associated with treatment outcomes.
METHODS


Thirty-two older adults with major depression (mean age = 72.7) were randomized to 9-weeks of either PST or ""Engage."" We assessed rsFC at baseline and week 6. We placed seeds in three a priori regions of interest: subgenual anterior cingulate cortex (sgACC), dorsal anterior cingulate cortex (dACC), and nucleus accumbens (NAcc). Outcome measures included the Hamilton Depression Rating Scale (HAMD) and the Behavioral Activation for Depression Scale (BADS).
RESULTS


In both PST and ""Engage,"" higher rsFC between the sgACC and middle temporal gyrus at baseline was associated with greater improvement in depression severity (HAMD). Preliminary findings suggested that in ""Engage"" treated participants, lower rsFC between the dACC and dorsomedial prefrontal cortex at baseline was associated with HAMD improvement. Finally, in Engage only, increased rsFC from baseline to week 6 between NAcc and Superior Parietal Cortex was associated with increased BADS scores.
CONCLUSION


The results suggest that patients who present with higher rsFC between the sgACC and a structure within the DMN may benefit from behavioral psychotherapies for late life depression. ""Engage"" may lead to increased rsFC within the reward system reflecting a reconditioning of the reward systems by reward exposure.",2020,"In both PST and ""Engage,"" higher rsFC between the sgACC and middle temporal gyrus at baseline was associated with greater improvement in depression severity (HAMD).",['Thirty-two older adults with major depression (mean age\u202f=\u202f72.7'],"['Problem solving therapy (PST', 'PST or ""Engage']","['BADS scores', 'anterior cingulate cortex (sgACC), dorsal anterior cingulate cortex (dACC), and nucleus accumbens (NAcc', 'depression severity (HAMD', 'Hamilton Depression Rating Scale (HAMD) and the Behavioral Activation for Depression Scale (BADS']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",32.0,0.0436281,"In both PST and ""Engage,"" higher rsFC between the sgACC and middle temporal gyrus at baseline was associated with greater improvement in depression severity (HAMD).","[{'ForeName': 'Nili', 'Initials': 'N', 'LastName': 'Solomonov', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine (NS, LWV, LO, FMG, and GSA), White Plains, NY. Electronic address: nis2051@med.cornell.edu.'}, {'ForeName': 'Lindsay W', 'Initials': 'LW', 'LastName': 'Victoria', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine (NS, LWV, LO, FMG, and GSA), White Plains, NY.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Dunlop', 'Affiliation': 'Feil Family Brain Mind Research Institute, Weill Cornell Medicine (KD and CL), New York, NY.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Respino', 'Affiliation': 'Rush University Medical Center (MR), Chicago, IL.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hoptman', 'Affiliation': 'The Nathan S. Kline Institute for Psychiatric Research (MJH), Orangeburg, NY; New York University School of Medicine (MJH), New York, NY.'}, {'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Zilcha-Mano', 'Affiliation': 'Columbia University (SZM), New York, NY; Haifa University (SZM), Haifa, Israel.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Oberlin', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine (NS, LWV, LO, FMG, and GSA), White Plains, NY.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Liston', 'Affiliation': 'Feil Family Brain Mind Research Institute, Weill Cornell Medicine (KD and CL), New York, NY.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Areán', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences (PAA), University of Washington School of Medicine, Seattle, WA.'}, {'ForeName': 'Faith M', 'Initials': 'FM', 'LastName': 'Gunning', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine (NS, LWV, LO, FMG, and GSA), White Plains, NY.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Alexopoulos', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine (NS, LWV, LO, FMG, and GSA), White Plains, NY.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.04.008']
45,32313980,Dopaminergic and noradrenergic manipulation of anticipatory reward and probability event-related potentials.,"Predicting what will happen in the future in terms of potential reward is essential in daily life. The aim of the current study was to investigate the neurotransmitter systems involved in the anticipation of reward value and probability. We hypothesized that dopaminergic and noradrenergic antagonism would affect anticipation of reward value and probability, respectively. Twenty-three healthy participants were included in a haloperidol (2 mg) × clonidine (0.150 mg) × placebo cross-over design and subjected to a Go/NoGo experimental task during which cues signaled the probability of subsequent target appearance. Reward value (amount of money that could be won for correct and fast responding to the target) as well as probability of target appearance was orthogonally manipulated across four task blocks. Cue-elicited EEG event-related potentials were recorded to assess anticipation of value and probability, respectively. The processing of reward value was affected by dopaminergic antagonism (haloperidol), as evidenced by reduction of the reward-related positivity and P300 to reward cues. This reduction was specifically significant for subjects with high baseline dopamine levels for the P300 and most pronounced for these subjects for the reward-related positivity. In contrast, the processing of reward probability was affected by noradrenergic antagonism (clonidine). In addition, both drugs reduced overall performance (omission rate, response speed variability). We conclude that at least anticipation of reward value and probability, respectively, is specifically affected by dopaminergic versus noradrenergic antagonism.",2020,"The processing of reward value was affected by dopaminergic antagonism (haloperidol), as evidenced by reduction of the reward-related positivity and P300 to reward cues.",['Twenty-three healthy participants were included in a haloperidol (2\xa0mg'],['clonidine'],"['overall performance (omission rate, response speed variability']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",23.0,0.109887,"The processing of reward value was affected by dopaminergic antagonism (haloperidol), as evidenced by reduction of the reward-related positivity and P300 to reward cues.","[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Schutte', 'Affiliation': 'Department of Experimental Psychology, Helmholtz Institute, Utrecht University, Heidelberglaan 1, 3584 CS, Utrecht, The Netherlands. iris.schutte2706@gmail.com.'}, {'ForeName': 'Peter K H', 'Initials': 'PKH', 'LastName': 'Deschamps', 'Affiliation': 'Department of Psychiatry, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Peter N', 'Initials': 'PN', 'LastName': 'van Harten', 'Affiliation': 'Department of Psychiatry and Psychology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'J Leon', 'Initials': 'JL', 'LastName': 'Kenemans', 'Affiliation': 'Department of Experimental Psychology, Helmholtz Institute, Utrecht University, Heidelberglaan 1, 3584 CS, Utrecht, The Netherlands.'}]",Psychopharmacology,['10.1007/s00213-020-05515-x']
46,32379487,A Randomized Sham-controlled Trial of 1-Hz and 10-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) of the Right Dorsolateral Prefrontal Cortex in Civilian Post-traumatic Stress Disorder: Un essai randomisé contrôlé simulé de stimulation magnétique transcrânienne repetitive (SMTr) de 1 Hz et 10 Hz du cortex préfrontal dorsolatéral droit dans le trouble de stress post-traumatique chez des civils.,"OBJECTIVE


Despite effective psychological and pharmacological treatments, there is a large unmet burden of illness in post-traumatic stress disorder (PTSD). Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive intervention and a putative treatment strategy for PTSD. The evidence base to date suggests that rTMS targeting the dorsolateral prefrontal cortex (DLPFC), in particular the right DLPFC, leads to improvements in PTSD symptoms. However, optimal stimulation parameters have yet to be determined. In this study, we examine the efficacy of high- and low-frequency rTMS of the right DLPFC using a randomized, double-blind, sham-controlled design in civilian PTSD.
METHODS


We conducted a 2-week single-site randomized sham-controlled trial of rTMS targeting the right DLPFC. We recruited civilians aged 19 to 70 with PTSD and randomized subjects with allocation concealment to daily 1-Hz rTMS, 10-Hz rTMS, or sham rTMS. The primary outcome was improvement in Clinician Administered PTSD Scale-IV (CAPS-IV). Secondary outcomes included change in depressive and anxiety symptoms.
RESULTS


We recruited 31 civilians with PTSD. One 1-Hz-treated patient developed transient suicidal ideation. Analyses revealed significant improvement in CAPS-IV symptoms in the 1-Hz group relative to sham (Hedges'  g  = -1.07) but not in the 10-Hz group. This was not attributable to changes in anxious or depressive symptomatology. Ten-Hz stimulation appeared to improve depressive symptoms compared to sham.
CONCLUSION


Low-frequency rTMS is efficacious in the treatment of civilian PTSD. Our data suggest that high-frequency rTMS of the right DLPFC is worthy of additional investigation for the treatment of depressive symptoms comorbid with PTSD.",2020,Analyses revealed significant improvement in CAPS-IV symptoms in the 1-Hz group relative to sham (Hedges'  g  = -1.07) but not in the 10-Hz group.,"['We recruited civilians aged 19 to 70 with PTSD and randomized subjects with', '31 civilians with PTSD', 'Civilian Post-traumatic Stress Disorder']","['allocation concealment to daily 1-Hz rTMS, 10-Hz rTMS, or sham rTMS', 'rTMS', 'Repetitive transcranial magnetic stimulation (rTMS', '1-Hz and 10-Hz Repetitive Transcranial Magnetic Stimulation (rTMS']","['CAPS-IV symptoms', 'anxious or depressive symptomatology', 'Clinician Administered PTSD Scale-IV (CAPS-IV', 'change in depressive and anxiety symptoms', 'transient suicidal ideation', 'depressive symptoms']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.283303,Analyses revealed significant improvement in CAPS-IV symptoms in the 1-Hz group relative to sham (Hedges'  g  = -1.07) but not in the 10-Hz group.,"[{'ForeName': 'Kawai', 'Initials': 'K', 'LastName': 'Leong', 'Affiliation': 'Department of Psychiatry, 8166University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': 'Department of Psychiatry, 8166University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Ong', 'Affiliation': 'Department of Psychiatry, 8166University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Zwicker', 'Affiliation': 'Department of Psychiatry, 8166University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Willan', 'Affiliation': '380154Vancouver General Hospital, British Columbia, Canada.'}, {'ForeName': 'Raymond W', 'Initials': 'RW', 'LastName': 'Lam', 'Affiliation': 'Department of Psychiatry, 8166University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'McGirr', 'Affiliation': 'Department of Psychiatry, 2129University of Calgary, Alberta, Canada.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743720923064']
47,32383748,Effect of Zinc Supplementation vs Placebo on Mortality Risk and HIV Disease Progression Among HIV-Positive Adults With Heavy Alcohol Use: A Randomized Clinical Trial.,"Importance


Zinc supplementation can reduce alcohol-related microbial translocation and inflammation.
Objective


To assess whether zinc supplementation reduces markers of mortality and risk of cardiovascular disease, reduces levels of inflammation and microbial translocation, and slows HIV disease progression in people with heavy alcohol use who are living with HIV/AIDS.
Design, Setting, and Participants


This study is a double-blinded placebo-controlled randomized clinical trial of zinc supplementation among participants recruited from 2013 to 2015. Participants were recruited from HIV and addiction clinical and nonclinical care sites in St Petersburg, Russia. Participants were adults (aged 18-70 years) with documented HIV infection who were antiretroviral therapy-naive at baseline and had past 30-day heavy alcohol consumption. Data analysis was performed from February 2017 to February 2020.
Intervention


Pharmacy-grade zinc gluconate supplementation (15 mg for men and 12 mg for women, taken daily by mouth for 18 months) was compared with a placebo.
Main Outcomes and Measures


The primary outcome was mortality risk measured as a change in Veterans Aging Cohort Study (VACS) Index score between baseline and 18 months. The VACS Index scores range from 0 to 164, with higher scores indicating higher mortality risk. Secondary outcomes were change in CD4 cell count between baseline and 18 months, the assessment of cardiovascular disease risk (Reynolds Risk Score, which ranges from 0% to 100%, with higher scores indicating higher risk), and changes in inflammatory or microbial translocation biomarkers at 18 months. Adjusted linear regression analyses were performed.
Results


A total of 254 participants (184 men [72%]; mean [SD] age, 34 [6] years) were enrolled in the trial; 126 were randomized to receive zinc, and 128 were randomized to receive placebo. Participants had high CD4 cell counts (mean [SD], 521 [292] cells/mm3), and 188 (74%) reported heavy drinking in the past week. In the main analyses, zinc supplementation did not affect changes in the VACS Index score at 18 months (change for zinc, mean [SD], 0.49 [14.6]; median [interquartile range], 0.0 [-7.0 to 6.0]; change for placebo, mean [SD], 5.5 [17.2]; median [interquartile range], 6.0 [-6.0 to 14.0]; adjusted mean difference [AMD], -4.68; 95% CI, -9.62 to 0.25; P = .06) or any secondary outcomes, including change in CD4 cell count (AMD, 41.8 cells/mm3; 95% CI, -20.3 to 103.8 cells/mm3; P = .19), Reynolds Risk Score (AMD, -0.014; 95% CI, -0.167 to 0.139; P = .85), interleukin-6 level (AMD, -0.13 pg/mL; 95% CI, -0.38 to 0.11 pg/mL; P = .30), dimerized plasmin fragment D level (AMD, -0.21 μg/mL fibrinogen equivalent units; 95% CI, -0.48 to 0.07 μg/mL fibrinogen equivalent units; P = .14), soluble CD14 level (AMD, -38.01 ng/mL; 95% CI, -166.90 to 90.88 ng/mL; P = .56), intestinal fatty acid binding protein level (AMD, 0.08 pg/mL; 95% CI, -0.07 to 0.22 pg/mL; P = .32), and lipopolysaccharide binding protein level (AMD, -0.09 ng/mL; 95% CI, -0.23 to 0.06 ng/mL; P = .24). In the per-protocol analyses, zinc supplementation statistically significantly affected changes in the VACS Index score at 18 months (AMD, -7.49; 95% CI, -13.74 to -1.23; P = .02); however, the adherence rate to zinc supplementation was 51%.
Conclusions and Relevance


Zinc supplementation did not reduce mortality risk, CD4 cell counts, cardiovascular disease risk, and levels of inflammation or microbial translocation in people with heavy alcohol use who are living with HIV/AIDS. Zinc supplementation did not change the VACS Index score but may have been limited by low adherence.
Trial Registration


ClinicalTrials.gov Identifier: NCT01934803.",2020,"In the per-protocol analyses, zinc supplementation statistically significantly affected changes in the VACS Index score at 18 months (AMD, -7.49; 95% CI, -13.74 to -1.23; P = .02); however, the adherence rate to zinc supplementation was 51%.
","['participants recruited from 2013 to 2015', 'Participants were adults (aged 18-70 years) with documented HIV infection who were antiretroviral therapy-naive at baseline and had past 30-day heavy alcohol consumption', 'HIV-Positive Adults With Heavy Alcohol Use', 'Participants were recruited from HIV and addiction clinical and nonclinical care sites in St Petersburg, Russia', 'A total of 254 participants (184 men [72%]; mean [SD] age, 34 [6] years) were enrolled in the trial; 126', 'people with heavy alcohol use who are living with HIV/AIDS']","['Zinc supplementation', 'zinc supplementation', 'Zinc Supplementation vs Placebo', 'Intervention\n\n\nPharmacy-grade zinc gluconate supplementation', 'placebo']","['Mortality Risk and HIV Disease Progression', 'mortality risk', 'cardiovascular disease risk (Reynolds Risk Score', 'change in CD4 cell count', 'high CD4 cell counts', 'VACS Index score', 'changes in inflammatory or microbial translocation biomarkers', 'soluble CD14 level', 'mortality risk measured as a change in Veterans Aging Cohort Study (VACS', 'VACS Index scores range', 'interleukin-6 level', 'adherence rate to zinc supplementation', 'lipopolysaccharide binding protein level', 'mortality and risk of cardiovascular disease, reduces levels of inflammation and microbial translocation, and slows HIV disease progression', 'Index score', 'intestinal fatty acid binding protein level', 'heavy drinking', 'dimerized plasmin fragment D level', 'mortality risk, CD4 cell counts, cardiovascular disease risk, and levels of inflammation or microbial translocation', 'Reynolds Risk Score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0337950', 'cui_str': 'Site of care'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0149381', 'cui_str': 'Zinc Gluconate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1141957', 'cui_str': 'HIV disease progression'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040715', 'cui_str': 'Chromosomal translocation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0065054', 'cui_str': 'lipopolysaccharide-binding protein'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0016016', 'cui_str': 'Plasmin'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}]",126.0,0.736847,"In the per-protocol analyses, zinc supplementation statistically significantly affected changes in the VACS Index score at 18 months (AMD, -7.49; 95% CI, -13.74 to -1.23; P = .02); however, the adherence rate to zinc supplementation was 51%.
","[{'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Freiberg', 'Affiliation': 'Vanderbilt Center for Clinical Cardiovascular Trials Evaluation (V-C3REATE), Cardiovascular Division, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Debbie M', 'Initials': 'DM', 'LastName': 'Cheng', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Gnatienko', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Blokhina', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Coleman', 'Affiliation': 'Biostatistics and Epidemiology Data Analytics Center (BEDAC), Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Margaret F', 'Initials': 'MF', 'LastName': 'Doyle', 'Affiliation': 'Larner College of Medicine, Department of Pathology and Laboratory Medicine, The University of Vermont, Colchester.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Yaroslavtseva', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Bridden', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Kaku', 'Initials': 'K', 'LastName': 'So-Armah', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Tracy', 'Affiliation': 'Larner College of Medicine, Department of Pathology and Laboratory Medicine, The University of Vermont, Colchester.'}, {'ForeName': 'Kendall', 'Initials': 'K', 'LastName': 'Bryant', 'Affiliation': 'HIV/AIDS Research, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Lioznov', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Krupitsky', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Samet', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.4330']
48,32384914,"Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA).","BACKGROUND


One major limitation for less invasive surfactant administration (LISA) is the difficulty in providing sedation before this procedure and the competitive risk of respiratory depression versus avoidance of intubation for most sedative or analgesic drugs used in this context. The objective of this study is to compare the need for mechanical ventilation within 72 h of life following premedication with propofol, versus placebo (rescue with ketamine), for the LISA procedure in preterm neonates born before 32 weeks gestational age (wGA).
METHODS


ProLISA is a phase III, non-inferiority, multicenter, double blind, randomized, placebo controlled trial designed according to the SPIRIT Statement. Neonates born before 32 wGA in 12 geographically dispersed Neonatal Intensive Care Units in France needing surfactant will be included from September 2019 to September 2022. A sample of 542 patients is needed. The neonate is randomized to the intervention (propofol) or control placebo group. Open label rescue treatment with ketamine is possible in both groups if FANS (Faceless Acute Neonatal pain Scale) is ≥6. To guide drug administration, FANS is scored before attempting laryngoscopy. Once an adequate score has been obtained, LISA is performed according to a standardized protocol. The primary outcome is the need for mechanical ventilation within 72 h of life. Secondary outcomes are tolerance of the procedure, pain evaluation, hemodynamic and neurologic parameters after the intervention, morbidities before discharge and neurodevelopmental assessment at 2 years of age.
DISCUSSION


This paper describes the first multicenter, double-blind, randomized, placebo-controlled trial on this topic and will provide crucial information to support implementation of the LISA procedure.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT04016246. Registered 06 June 2019, N°EUDRACT: 2018-002876-41.",2020,Open label rescue treatment with ketamine is possible in both groups if FANS (Faceless Acute Neonatal pain Scale) is ≥6.,"['Neonates born before 32 wGA in 12 geographically dispersed Neonatal Intensive Care Units in France needing surfactant will be included from September 2019 to September 2022', '542 patients', 'preterm neonates born before 32\u2009weeks gestational age (wGA']","['Propofol versus placebo', 'intervention (propofol) or control placebo', 'ketamine', 'invasive surfactant administration (LISA', 'propofol, versus placebo (rescue with ketamine', 'placebo']","['need for mechanical ventilation within 72\u2009h of life', 'tolerance of the procedure, pain evaluation, hemodynamic and neurologic parameters after the intervention, morbidities before discharge and neurodevelopmental assessment at 2\u2009years of age']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",,0.721645,Open label rescue treatment with ketamine is possible in both groups if FANS (Faceless Acute Neonatal pain Scale) is ≥6.,"[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Chevallier', 'Affiliation': 'UMR 5525 ThEMAS, CNRS, TIMC-IMAG, Grenoble Alps University, Grenoble, France. mchevallier3@chu-grenoble.fr.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Durrmeyer', 'Affiliation': 'Neonatal Intensive Care Unit, Centre Hospitalier Intercommunal de Créteil, Créteil, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ego', 'Affiliation': 'Neonatal Intensive Care Unit, Grenoble Alps University Hospital, Grenoble, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Debillon', 'Affiliation': 'UMR 5525 ThEMAS, CNRS, TIMC-IMAG, Grenoble Alps University, Grenoble, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pediatrics,['10.1186/s12887-020-02112-x']
49,32376491,"Aeroallergen Sensitization, Serum IgE, and Eosinophilia as Predictors of Response to Omalizumab Therapy During the Fall Season Among Children with Persistent Asthma.","BACKGROUND


Perennial aeroallergen sensitization is associated with greater asthma morbidity and is required for treatment with omalizumab.
OBJECTIVE


To investigate the predictive relationship between the number of aeroallergen sensitizations, total serum IgE, and serum eosinophil count, and response to omalizumab in children and adolescents with asthma treated during the fall season.
METHODS


This analysis includes inner-city patients with persistent asthma and recent exacerbations aged 6-20 years comprising the placebo- and omalizumab-treated groups in 2 completed randomized clinical trials, the Inner-City Anti-IgE Therapy for Asthma study and the Preventative Omalizumab or Step-Up Therapy for Fall Exacerbations study. Logistic regression modeled the relationship between greater degrees of markers of allergic inflammation and the primary outcome of fall season asthma exacerbations.
RESULTS


The analysis included 761 participants who were 62% male and 59% African American with a median age of 10 years. Fall asthma exacerbations were significantly higher in children with greater numbers of aeroallergen-specific sensitizations in the placebo group (odds ratio [OR], 1.33; 95% confidence interval [CI], 1.11-1.60; P < .01), but not in the omalizumab-treated children (OR, 1.08; 95% CI, 0.91-1.28; P = .37), indicating a significant differential effect (P < .01). Likewise, there was a differential effect of omalizumab treatment in children with greater baseline total serum IgE levels (P < .01) or greater baseline serum eosinophil counts (P < .01). Multiple aeroallergen sensitization was the best predictor of response to omalizumab; treated participants sensitized to ≥4 different groups of aeroallergens had a 51% reduction in the odds of a fall exacerbation (OR, 0.49; 95% CI, 0.30-0.81; P < .01).
CONCLUSIONS


In preventing fall season asthma exacerbations, treatment with omalizumab was most beneficial in children with a greater degree of allergic inflammation.",2020,"Fall asthma exacerbations were significantly higher in children with greater numbers of aeroallergen-specific sensitizations in the placebo group (OR 1.33, 95% CI 1.11-1.60, p<0.01), but not in the omalizumab-treated children (OR 1.08, 95% CI 0.91-1.28, p=0.37) indicating a significant differential effect (p<0.01).","['city patients with persistent asthma and recent exacerbations aged 6-20 years comprising the', '761 participants who were 62% male and 59% African American with a median age of 10 years', 'children and adolescents with asthma treated during the fall season', 'Children with Persistent Asthma']","['Inner-City Anti-IgE Therapy for Asthma (ICATA) study and the Preventative Omalizumab or Step-Up Therapy', 'omalizumab', 'placebo and omalizumab']","['baseline total serum IgE levels', 'fall season asthma exacerbations', 'Aeroallergen Sensitization, Serum IgE, and Eosinophilia', 'allergic inflammation', 'Fall asthma exacerbations', 'fall exacerbation', 'total serum IgE, and serum eosinophil count, and response to omalizumab']","[{'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0557849', 'cui_str': 'Inner city'}, {'cui': 'C0051978', 'cui_str': 'Anti-Immunoglobulin E antibody'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0001697', 'cui_str': 'Aeroallergen'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0014457', 'cui_str': 'Eosinophilia'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}]",761.0,0.144186,"Fall asthma exacerbations were significantly higher in children with greater numbers of aeroallergen-specific sensitizations in the placebo group (OR 1.33, 95% CI 1.11-1.60, p<0.01), but not in the omalizumab-treated children (OR 1.08, 95% CI 0.91-1.28, p=0.37) indicating a significant differential effect (p<0.01).","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sheehan', 'Affiliation': ""Children's National Hospital and George Washington University School of Medicine and Health Sciences, Washington, DC. Electronic address: wsheehan@childrensnational.org.""}, {'ForeName': 'Rebecca Z', 'Initials': 'RZ', 'LastName': 'Krouse', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, NC.'}, {'ForeName': 'Agustin', 'Initials': 'A', 'LastName': 'Calatroni', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, NC.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Gergen', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Rockville, Md.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Gern', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wis.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Gill', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Tex.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Gruchalla', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Tex.'}, {'ForeName': 'Gurjit K', 'Initials': 'GK', 'LastName': 'Khurana Hershey', 'Affiliation': ""Cincinnati Children's Hospital, Cincinnati, Ohio.""}, {'ForeName': 'Meyer', 'Initials': 'M', 'LastName': 'Kattan', 'Affiliation': 'College of Physicians and Surgeons, Columbia University, New York, NY.'}, {'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Kercsmar', 'Affiliation': ""Cincinnati Children's Hospital, Cincinnati, Ohio.""}, {'ForeName': 'Carin I', 'Initials': 'CI', 'LastName': 'Lamm', 'Affiliation': 'College of Physicians and Surgeons, Columbia University, New York, NY.'}, {'ForeName': 'Frederic F', 'Initials': 'FF', 'LastName': 'Little', 'Affiliation': 'Boston University School of Medicine, Boston, Mass.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Makhija', 'Affiliation': ""Lurie Children's Hospital and Northwestern University School of Medicine, Chicago, Ill.""}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Searing', 'Affiliation': ""Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, Colo.""}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Zoratti', 'Affiliation': 'Henry Ford Health System and Wayne State University School of Medicine, Detroit, Mich.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wis.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Teach', 'Affiliation': ""Children's National Hospital and George Washington University School of Medicine and Health Sciences, Washington, DC.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.03.051']
50,32383337,Incidence and characteristics of pregnancy-related death across ten low- and middle-income geographical regions: secondary analysis of a cluster randomised controlled trial.,"OBJECTIVE


The aim of this article is to describe the incidence and characteristics of pregnancy-related death in low- and middle-resource settings, in relation to the availability of key obstetric resources.
DESIGN


This is a secondary analysis of a stepped-wedge cluster randomised controlled trial.
SETTING


This trial was undertaken at ten sites across eight low- and middle-income countries in sub-Saharan Africa, India and Haiti.
POPULATION


Institutional-level consent was obtained and all women presenting for maternity care were eligible for inclusion.
METHODS


Pregnancy-related deaths were collected prospectively from routine data sources and active case searching.
MAIN OUTCOME MEASURES


Pregnancy-related death, place, timing and age of maternal death, and neonatal outcomes in women with this outcome.
RESULTS


Over 20 months, in 536 233 deliveries there were 998 maternal deaths (18.6/10 000, range 28/10 000-630/10 000). The leading causes of death were obstetric haemorrhage (36.0%, n = 359), hypertensive disorders of pregnancy (20.6%, n = 206), sepsis (14.1%, n = 141) and other (26.5%, n = 264). Approximately a quarter of deaths occurred prior to delivery (28.4%, n = 283), 35.7% (n = 356) occurred on the day of delivery and 35.9% (n = 359) occurred after delivery. Half of maternal deaths (50.6%; n = 505) occurred in women aged 20-29 years, 10.3% (n = 103) occurred in women aged under 20 years, 34.5% (n = 344) occurred in women aged 30-39 years and 4.6% (n = 46) occurred in women aged ≥40 years. There was no measured association between the availability of key obstetric resources and the rate of pregnancy-related death.
CONCLUSIONS


The large variation in the rate of pregnancy-related death, irrespective of resource availability, emphasises that inequality and inequity in health care persists.
TWEETABLE ABSTRACT


Inequality and inequity in pregnancy-related death persists globally, irrespective of resource availability.",2020,"Approximately a quarter of deaths occurred prior to delivery (28.4%, n=283), 35.7% on the day of delivery (n=356) and 35.9% after delivery (n=359).","['Pregnancy-related deaths were prospectively collected from routine data sources and active case finding', '10 sites across eight low and middle-income countries in sub-Saharan Africa, India and Haiti', 'Half of maternal deaths (50.6%; n=505) occurred in women aged 20-29, 10.3% under 20 years (n=103), 34.5% aged 30-39 (n=344) and 4.6% (n=46) aged ≥40', 'women presenting for maternity care were eligible for inclusion']",[],"['Incidence and characteristics of pregnancy-related death', '998 maternal deaths', 'availability of key obstetric resources and the rate of pregnancy-related death', 'Pregnancy-related death, place, timing and age of maternal death and neonatal outcomes', 'sepsis', 'hypertensive disorders of pregnancy']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0011001', 'cui_str': 'Data Sources'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}]",,0.351709,"Approximately a quarter of deaths occurred prior to delivery (28.4%, n=283), 35.7% on the day of delivery (n=356) and 35.9% after delivery (n=359).","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Vousden', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Holmes', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Gidiri', 'Affiliation': 'Department of Obstetrics and Gynaecology, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Goudar', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sandall', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chinkoyo', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ndola Teaching Hospital, Ndola, Zambia.'}, {'ForeName': 'L Y', 'Initials': 'LY', 'LastName': 'Kumsa', 'Affiliation': 'Maternity Worldwide, Brighton, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'Maternity Worldwide, Brighton, UK.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Charantimath', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bellad', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nakimuli', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Vwalika', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16309']
51,32379695,Effect of wrist-ankle acupuncture therapy combined with auricular acupuncture on cancer pain: A four-parallel arm randomized controlled trial.,"BACKGROUND


Cancer pain affects the quality of life of cancer patients; therefore, various methods exist for alleviating the adverse effects caused by cancer pain. Nonpharmacological intervention is regarded as an important means of auxiliary therapy for drug treatment, with acupuncture receiving the most attention; However, there are numerous types of acupuncture therapies, including acupuncture, wrist-ankle acupuncture (WAA) and auricular acupuncture (AA). Previous studies have demonstrated that all types of acupuncture therapy can alleviate cancer pain. However, the effects and pathways of different acupuncture treatments are not similar, and it is unknown whether single therapy or combination therapy has better analgesic effects. This study aimed to examine the effect of WAA therapy combined with AA on cancer pain.
DESIGN


A randomized controlled trial.
METHOD


A total of 160 patients were selected and randomly divided into groups A, B, C and D, with 40 patients in each group. Group A received conventional analgesia alone, with opioids administered based on the World Health Organization (WHO) 3-tiered ""cancer pain ladder"". Group B received WAA, in addition to the treatment received by group A. Group C received AA, in addition to the treatment received by group A. Group D received WAA combined with AA, in addition to the treatment received by group A. Analgesic effects and analgesic drug use before and 3, 5 and 7 days after treatment were observed in each group.
RESULT


A total of 159 patients were included in the analysis. The verbal rating scale (VRS) and numeric rating scale (NRS) scores for patients who received mono-acupuncture therapy and combination therapy for 1 week were significantly different from those of the control group. Combination therapy had a stronger effect on the VRS score and a faster onset time, based on the NRS score, and the patients who received combination therapy had reduced analgesic drug use.
CONCLUSION


WAA combined with AA can more quickly reduce pain symptoms with more lasting analgesic effects and can effectively reduce analgesic drug use.",2020,"Combination therapy had a stronger effect on the VRS score and a faster onset time, based on the NRS score, and the patients who received combination therapy had reduced analgesic drug use.
","['A total of 159 patients were included in the analysis', 'cancer patients', '160 patients']","['conventional analgesia alone, with opioids administered based on the World Health Organization (WHO) 3-tiered ""cancer pain ladder', 'WAA therapy combined with AA', 'mono-acupuncture therapy and combination therapy', 'WAA', 'wrist-ankle acupuncture therapy combined with auricular acupuncture', 'WAA combined with AA', 'Nonpharmacological intervention', 'acupuncture therapy']","['VRS score', 'verbal rating scale (VRS) and numeric rating scale (NRS) scores', 'pain symptoms', 'cancer pain']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0336762', 'cui_str': 'Ladder'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0752217', 'cui_str': 'Ear Acupuncture'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4274441', 'cui_str': 'Verbal Rating Scale score'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}]",160.0,0.166836,"Combination therapy had a stronger effect on the VRS score and a faster onset time, based on the NRS score, and the patients who received combination therapy had reduced analgesic drug use.
","[{'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Xu', 'Affiliation': ""Nursing Department, The Third Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou, China. Electronic address: 785514523@qq.com.""}, {'ForeName': 'Shi-Lai', 'Initials': 'SL', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, Quanzhou Medical College, Quanzhou, China. Electronic address: 247872083@qq.com.'}, {'ForeName': 'Shao-Qing', 'Initials': 'SQ', 'LastName': 'Su', 'Affiliation': ""People's Hospital Affiliated of Fujian University of Traditional Chinese Medicine, Fuzhou, China.""}, {'ForeName': 'Bi-Xia', 'Initials': 'BX', 'LastName': 'Huang', 'Affiliation': ""The Third Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou, China.""}, {'ForeName': 'Xin-Mei', 'Initials': 'XM', 'LastName': 'Lan', 'Affiliation': ""The Third Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou, China.""}, {'ForeName': 'Ru-Jie', 'Initials': 'RJ', 'LastName': 'Yao', 'Affiliation': ""The Third Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou, China.""}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101170']
52,32385765,"In shoulder adhesive capsulitis, ultrasound-guided anterior hydrodilatation in rotator interval is more effective than posterior approach: a randomized controlled study.","Shoulder adhesive capsulitis, also called frozen shoulder, is a musculoskeletal disorder associated with pain and functional disability. This study aimed to compare the effectiveness of shoulder ultrasound-guided hydrodilatation with corticosteroid, via rotator interval (RI) anteriorly, versus posterior approach, in adhesive capsulitis patients. All patients received exercise program following injection.
PATIENTS AND METHODS


A prospective randomized controlled study among 60 consecutive adhesive capsulitis patients was randomized into two equal groups. Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach; group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach. Both groups received guided stretching exercises for 3 months after injection. Baseline and 3 months evaluation of pain by visual analogue scale (VAS), shoulder pain and disability index (SPADI), and range of motion (ROM) had been recorded for all patients.
RESULTS


Both groups showed significant improvement 3 months after hydrodilatation regarding VAS pain, external rotation, and SPADI. Only in group II (RI anterior approach) improvement was observed regarding flexion and abduction. There was no improvement regarding extension or internal rotation in either group. When comparing the improvement in both groups after hydrodilatation, group II (anterior approach) showed a statistically significant higher level of improvement regarding VAS pain (p = 0.003), SPADI, flexion, abduction, and external rotation, compared to group I (p < 0.001). Extension, internal rotation, and adduction were not different.
CONCLUSIONS


Ultrasound-guided anterior rotator interval hydrodilatation for adhesive capsulitis, followed by guided exercise, is clinically and functionally more effective than the conventional posterior approach.",2020,There was no improvement regarding extension or internal rotation in either group.,"['60 consecutive adhesive capsulitis patients', 'adhesive capsulitis patients']","['guided stretching exercises', 'exercise program following injection', 'ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach; group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach', 'shoulder ultrasound-guided hydrodilatation with corticosteroid, via rotator interval (RI) anteriorly, versus posterior approach']","['SPADI, flexion, abduction, and external rotation', 'flexion and abduction', 'VAS pain, external rotation, and SPADI', 'pain by visual analogue scale (VAS), shoulder pain and disability index (SPADI), and range of motion (ROM', 'Extension, internal rotation, and adduction', 'extension or internal rotation', 'VAS pain']","[{'cui': 'C0158300', 'cui_str': 'Capsulitis, Adhesive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}]",60.0,0.0893016,There was no improvement regarding extension or internal rotation in either group.,"[{'ForeName': 'Basant', 'Initials': 'B', 'LastName': 'Elnady', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Elsayed M', 'Initials': 'EM', 'LastName': 'Rageh', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Manal Shawky', 'Initials': 'MS', 'LastName': 'Hussein', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohammed Hassan', 'Initials': 'MH', 'LastName': 'Abu-Zaid', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Dalia El-Sayed', 'Initials': 'DE', 'LastName': 'Desouky', 'Affiliation': 'Department of public health and community medicine, Menoufia University, Shibin Al Kawm, Egypt.'}, {'ForeName': 'Tohamy', 'Initials': 'T', 'LastName': 'Ekhouly', 'Affiliation': 'Department of Radiology, Benha University, Benha, Egypt.'}, {'ForeName': 'Johannes J', 'Initials': 'JJ', 'LastName': 'Rasker', 'Affiliation': 'Faculty of Behavioral, Management and Social sciences, Department Psychology, Health and Technology, University of Twente, PO box 217, 7500 AE, Enschede, Netherlands. j.j.rasker@utwente.nl.'}]",Clinical rheumatology,['10.1007/s10067-020-05131-2']
53,32389076,Biomechanical responses of young adults with unilateral transfemoral amputation using two types of mechanical stance control prosthetic knee joints.,"BACKGROUND


Prosthetic knee joint function is important in the rehabilitation of individuals with transfemoral amputation.
OBJECTIVES


The objective of this study was to assess the gait patterns associated with two types of mechanical stance control prosthetic knee joints-weight-activated braking knee and automatic stance-phase lock knee. It was hypothesized that biomechanical differences exist between the two knee types, including a prolonged swing-phase duration and exaggerated pelvic movements for the weight-activated braking knee during gait.
STUDY DESIGN


Prospective crossover study.
METHODS


Spatiotemporal, kinematic, and kinetic parameters were obtained via instrumented gait analysis for 10 young adults with a unilateral transfemoral amputation. Discrete gait parameters were extracted based on their magnitudes and timing.
RESULTS


A 1.01% ± 1.14% longer swing-phase was found for the weight-activated braking knee (p < 0.05). The prosthetic ankle push-off also occurred earlier in the gait cycle for the weight-activated braking knee. Anterior pelvic tilt was 3.3 ± 3.0 degrees greater for the weight-activated braking knee. This range of motion was also higher (p < 0.05) and associated with greater hip flexion angles.
CONCLUSIONS


Stance control affects biomechanics primarily in the early and late stance associated with prosthetic limb loading and unloading. The prolonged swing-phase time for the weight-activated braking knee may be associated with the need for knee unloading to initiate knee flexion during gait. The differences in pelvic tilt may be related to knee stability and possibly the different knee joint stance control mechanisms.
CLINICAL RELEVANCE


Understanding the influence of knee function on gait biomechanics is important in selecting and improving treatments and outcomes for individuals with lower-limb amputations. Weight-activated knee joints may result in undesired gait deviations associated with stability in early stance-phase, and swing-phase initiation in the late stance-phase of gait.",2020,A 1.01% ± 1.14% longer swing-phase was found for the weight-activated braking knee (p < 0.05).,"['individuals with lower-limb amputations', 'individuals with transfemoral amputation', '10 young adults with a unilateral transfemoral amputation', 'young adults with unilateral transfemoral amputation using two types of mechanical stance control prosthetic knee joints']",['mechanical stance control prosthetic knee joints-weight-activated braking knee and automatic stance-phase lock knee'],"['prolonged swing-phase duration and exaggerated pelvic movements', 'hip flexion angles', 'Biomechanical responses', 'weight-activated braking knee']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}, {'cui': 'C0002691', 'cui_str': 'Amputation above-knee'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0231753', 'cui_str': 'Knee locking'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0442801', 'cui_str': 'Exaggerated'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",10.0,0.0173578,A 1.01% ± 1.14% longer swing-phase was found for the weight-activated braking knee (p < 0.05).,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Andrysek', 'Affiliation': 'Holland Bloorview Kids Rehabilitation Hospital and Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'García', 'Affiliation': 'Instituto Teleton, Santiago, Chile.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Rozbaczylo', 'Affiliation': 'Instituto Teleton, Santiago, Chile.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Alvarez-Mitchell', 'Affiliation': 'Escuela de Kinesiologia, Universidad Andres Bello, Santiago, Chile.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Valdebenito', 'Affiliation': 'Instituto Teleton, Santiago, Chile.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Rotter', 'Affiliation': 'Instituto Teleton, Santiago, Chile.'}, {'ForeName': 'F Virginia', 'Initials': 'FV', 'LastName': 'Wright', 'Affiliation': 'Holland Bloorview Kids Rehabilitation Hospital and Department of Physical Therapy, University of Toronto, Toronto, ON, Canada.'}]",Prosthetics and orthotics international,['10.1177/0309364620916385']
54,32392833,"Effects of Augmented-Reality-Based Exercise on Muscle Parameters, Physical Performance, and Exercise Self-Efficacy for Older Adults.","This study was intended to determine the applicability of an augmented-reality-based muscle reduction prevention exercise program for elderly Korean women by observing changes in exercise self-efficacy and verifying the effectiveness of the program in the elderly after the application of the program. A total of 27 participants, who were elderly women aged 65+ and had not participated in any exercise programs until this study, were recruited for this study. They were divided into an experimental group (13 people) and a control group (14 people), and then the augmented-reality-based muscle reduction prevention exercise program was applied. This was a 30-min program, which included regular, aerobic, and flexibility exercises, and it was applied 5 times a week for 12 weeks. As a result of observing changes, it was found that the appendicular skeletal muscle mass (ASM) (F = 11.222,  p  < 0.002) and the skeletal muscle index (SMI) (kg/m 2 ) (F = 10.874,  p  < 0.003) muscle parameters increased more in the experimental group compared to the control group, and there was a significant increase in gait speed (m/s) (F = 7.221,  p  < 0.005). For physical performance, as a result of conducting the Senior Fitness Test (SFT), a significant change was observed in the chair stand test (F = 5.110,  p  < 0.033), 2-min step test (2MST) (F = 6.621,  p  < 0.020), and the timed up-and-go test (TUG) (F = 5.110,  p  < 0.032) and a significant increase was also observed for exercise self-efficacy (F = 20.464,  p  < 0.001). Finally, the augmented-reality-based exercise program in this study was found to be effective in inducing physical activity in the elderly. Therefore, the augmented-reality-based muscle reduction prevention exercise program is considered to be effective in increasing the sustainability of exercise, thus preventing muscle reduction in the elderly.",2020,"For physical performance, as a result of conducting the Senior Fitness Test (SFT), a significant change was observed in the chair stand test (F = 5.110,  p  < 0.033), 2-min step test (2MST) (F = 6.621,  p  < 0.020), and the timed up-and-go test (TUG) (F = 5.110,  p  < 0.032) and a significant increase was also observed for exercise self-efficacy (F = 20.464,  p  < 0.001).","['elderly Korean women', '27 participants, who were elderly women aged 65+ and had not participated in any exercise programs until this study, were recruited for this study', 'Older Adults']","['Augmented-Reality-Based Exercise', 'augmented-reality-based muscle reduction prevention exercise program', 'control group (14 people), and then the augmented-reality-based muscle reduction prevention exercise program']","['exercise self-efficacy', 'appendicular skeletal muscle mass (ASM', 'physical activity', 'gait speed (m/s', 'skeletal muscle index (SMI', 'Muscle Parameters, Physical Performance, and Exercise Self-Efficacy', 'chair stand test']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C5197824', 'cui_str': 'Mixed Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",27.0,0.0120384,"For physical performance, as a result of conducting the Senior Fitness Test (SFT), a significant change was observed in the chair stand test (F = 5.110,  p  < 0.033), 2-min step test (2MST) (F = 6.621,  p  < 0.020), and the timed up-and-go test (TUG) (F = 5.110,  p  < 0.032) and a significant increase was also observed for exercise self-efficacy (F = 20.464,  p  < 0.001).","[{'ForeName': 'Sangwan', 'Initials': 'S', 'LastName': 'Jeon', 'Affiliation': 'Exercise Rehabilitation Convergence Institute, Gachon University191 Hombakmoero, Yeonsu-gu, Incheon 406-799, Korea.'}, {'ForeName': 'Jiyoun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Exercise Rehabilitation & Welfare, Gachon University 191 Hombakmoero, Yeonsu-gu, Incheon 406799, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17093260']
55,32398160,"Nitrous oxide/oxygen plus acetaminophen versus morphine in ST elevation myocardial infarction: open-label, cluster-randomized, non-inferiority study.","BACKGROUND


Studies have shown disparate results on the consequences of morphine use in ST-segment elevation myocardial infarction (STEMI). No study has evaluated alternative treatments that could be at least non-inferior to morphine without its potentially damaging consequences for myocardial function and platelet reactivity. The aim of this study was to evaluate whether nitrous oxide/oxygen plus intravenous acetaminophen (NOO-A) is non-inferior to morphine to control chest pain in STEMI patients.
METHODS


This multicenter, open-label, cluster-randomized, controlled, non-inferiority study compared NOO-A with morphine in 684 prehospital patients with ongoing suspected STEMI of < 12 h duration and a pain rating score ≥ 4. The primary endpoint was the proportion of patients achieving pain relief (numeric rating score ≤ 3) after 30 min. Secondary safety endpoints included serious adverse events and death at 30 days.
RESULTS


The median baseline pain score was 7.0 in both groups. The primary endpoint occurred in 51.7% of the NOO-A group and 73.6% of the morphine group (absolute risk difference - 21.7%; 95% confidence interval - 29.6 to - 13.8). At 30 days, the rate of serious adverse events was 16.0 and 18.8% in the NOO-A and morphine groups respectively (p = NS). The rate of death was 1.8% (NOO-A group) and 3.8% (morphine group) (p = NS).
CONCLUSION


Analgesia provided by NOO-A was inferior to morphine at 30 min in patients with acute STEMI in the prehospital setting. Rates of serious adverse events did not differ between groups.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02198378.",2020,Analgesia provided by NOO-A was inferior to morphine at 30 min in patients with acute STEMI in the prehospital setting.,"['684 prehospital patients with ongoing suspected STEMI of <\u200912\u2009h duration and a pain rating score\u2009≥\u20094', 'STEMI patients', 'ST elevation myocardial infarction']","['nitrous oxide/oxygen plus intravenous acetaminophen (NOO-A', 'NOO-A with morphine', 'Nitrous oxide/oxygen plus acetaminophen', 'morphine']","['rate of death', 'proportion of patients achieving pain relief (numeric rating score', 'median baseline pain score', 'serious adverse events and death at 30\u2009days', 'rate of serious adverse events', 'Rates of serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}]","[{'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",684.0,0.243387,Analgesia provided by NOO-A was inferior to morphine at 30 min in patients with acute STEMI in the prehospital setting.,"[{'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Charpentier', 'Affiliation': 'Emergency Department, Toulouse University Hospital, INSERM UMR 1027, University Toulouse III Paul Sabatier, Toulouse, France. charpentier.s@chu-toulouse.fr.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Galinski', 'Affiliation': 'Emergency Department - SAMU 33, CHU de Bordeaux; INSERM U1219 - Injury Epidemiology Transport Occupation"" team, University Bordeaux II, 33000, Bordeaux, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Bounes', 'Affiliation': 'SAMU31, Toulouse University Hospital; University Toulouse III Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Ricard-Hibon', 'Affiliation': 'Pôle Emergency Department, SAMU - Centre Hospitalier René Dubos Pontoise, 95300, Pontoise, France.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'El-Khoury', 'Affiliation': 'Emergency Department and RESCUe Network, Lucien Hussel Hospital, Vienne, France.'}, {'ForeName': 'Meyer', 'Initials': 'M', 'LastName': 'Elbaz', 'Affiliation': 'Department of Cardiology, Rangueil University Hospital, Toulouse, France.'}, {'ForeName': 'François-Xavier', 'Initials': 'FX', 'LastName': 'Ageron', 'Affiliation': 'Emergency Department, Centre Hospitalier Annecy Genevois, Annecy, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Manzo-Silberman', 'Affiliation': 'Cardiology department, Lariboisire Hospital, APHP, Paris, France.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Soulat', 'Affiliation': 'SAMU 35 SMUR Urgences adultes, Centre Hospitalier Universitaire Rennes, Université Rennes 1, Rennes, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Lapostolle', 'Affiliation': 'SAMU 93 - UF Recherche-Enseignement-Qualité Université Paris 13, Sorbonne Paris Cité, Inserm U942 Hôpital Avicenne, AP-HP, 125, rue de Stalingrad, 93009, Bobigny, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gérard', 'Affiliation': ""Hospices Civils de Lyon SAMU 69 - Hôpital Édouard HERRIOT 5, place d'Arsonval, 69437, LYON Cedex 03, France.""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Bregeaud', 'Affiliation': 'Hospital Centre of Chateauroux, Chateauroux, France.'}, {'ForeName': 'Vanina', 'Initials': 'V', 'LastName': 'Bongard', 'Affiliation': 'Department of Epidemiology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bonnefoy-Cudraz', 'Affiliation': 'Hôpital cardiologique Louis-Pradel, 69500, Lyon, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Scandinavian journal of trauma, resuscitation and emergency medicine",['10.1186/s13049-020-00731-y']
56,32383013,Preoperative antibiotic prophylaxis regimen in brain tumour surgery in Sweden: a quasi-experimental study.,"BACKGROUND


There has been varied clinical practice concerning antibiotic prophylaxis in patients undergoing craniotomy. In Sweden, both Cloxacillin and Cefuroxime have frequently been used. We aimed to study the clinical effectiveness of these two regimens.
METHODS


A quasi-experimental design was used. The sample consisted of 580 adult (> 18 years) patients operated 2012-2015, of which 375 received Cloxacillin (pre-intervention group) and 205 received Cefuroxime (intervention group). Primary endpoint was the incidence of surgical site infection (SSI) 12 months after surgery, while secondary endpoints were the need for reoperation due to SSI, the amount antibiotics used and the number of visits in the outpatient clinic related to SSI. A control group from another institution was reviewed to rule out clinical trial effects.
RESULTS


When analysed by intention to treat, the pre-intervention group had a significant higher incidence of SSI, 13.3% (50/375) vs 5.4% (11/205) in the intervention group (p < 0.01). A treatment per protocol analysis confirmed the result. The number of reoperations due to SSI were significantly reduced in the intervention group, 3.4% (7/205) vs 8.3% (31/375) (p = 0.02), as was the total antibiotic use (p = 0.03) and the number of visits in the outpatient clinic (p < 0.01). In the control group, the reoperation rate as result of SSI was lower (p = 0.02) prior to the opposite change from Cefuroxime to Cloxacillin, 1.8% (27/1529) vs 3.1% (43/1378).
CONCLUSION


In Sweden, Cefuroxime as prophylaxis in brain tumour surgery by craniotomy seems to be superior to Cloxacillin.",2020,"In the control group, the reoperation rate as result of SSI was lower (p = 0.02) prior to the opposite change from Cefuroxime to Cloxacillin, 1.8% (27/1529) vs 3.1% (43/1378).
","['patients undergoing craniotomy', '580 adult (>\u200918\xa0years) patients operated 2012-2015, of which 375 received', 'brain tumour surgery in Sweden']","['Cefuroxime', 'Preoperative antibiotic prophylaxis regimen', 'Cloxacillin', 'Cloxacillin (pre-intervention group) and 205 received Cefuroxime', 'Cloxacillin and Cefuroxime']","['number of reoperations due to SSI', 'incidence of SSI', 'total antibiotic use', 'incidence of surgical site infection (SSI', 'reoperation rate as result of SSI', 'number of visits in the outpatient clinic', 'need for reoperation due to SSI, the amount antibiotics used and the number of visits in the outpatient clinic related to SSI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C4517818', 'cui_str': '580'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0009077', 'cui_str': 'Cloxacillin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}]",580.0,0.0480861,"In the control group, the reoperation rate as result of SSI was lower (p = 0.02) prior to the opposite change from Cefuroxime to Cloxacillin, 1.8% (27/1529) vs 3.1% (43/1378).
","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Skyrman', 'Affiliation': 'Department of Neurosurgery, Karolinska University Hospital, 171 76, Stockholm, Sweden. simon.skyrman@sll.se.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Bartek', 'Affiliation': 'Department of Neurosurgery, Karolinska University Hospital, 171 76, Stockholm, Sweden.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Haghighi', 'Affiliation': 'Department of Neurosurgery, Karolinska University Hospital, 171 76, Stockholm, Sweden.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Fornebo', 'Affiliation': 'Department of Neurosurgery, Karolinska University Hospital, 171 76, Stockholm, Sweden.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Skoglund', 'Affiliation': 'Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Asgeir Store', 'Initials': 'AS', 'LastName': 'Jakola', 'Affiliation': 'Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'von Vogelsang', 'Affiliation': 'Department of Neurosurgery, Karolinska University Hospital, 171 76, Stockholm, Sweden.'}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Förander', 'Affiliation': 'Department of Neurosurgery, Karolinska University Hospital, 171 76, Stockholm, Sweden.'}]",Acta neurochirurgica,['10.1007/s00701-020-04309-6']
57,32388647,"Suprascapular nerve block in hemiplegic shoulder pain: comparison of the effectiveness of placebo, local anesthetic, and corticosteroid injections-a randomized controlled study.","BACKGROUND


Shoulder pain is a common complication of hemiplegic patients that can interrupt their rehabilitation program and is associated with poorer outcomes. The usefulness of the suprascapular nerve block. (SSNB) in the stroke population has been suggested, but some concerns still remain.
OBJECTIVES


To investigate the effect of SSNB on pain intensity and passive range ofmotion (PROM) in patients with hemiplegic shoulder pain (HSP).
STUDY DESIGN


A prospective, double blind, randomized controlled trial was conductedin 34 stroke patients with HSP. They were randomly divided into three groups: Localanesthetic (LA) injection into the trapezius muscle (placebo group), LA injection into thesuprascapular notch, and LA and corticosteroid (CS) injections into the suprascapularnotch.The main outcome was visual analog scale (VAS) scores evaluated before andafter administration of the injection at 1 hour, 1 week, and 1 month.
RESULTS


There were significant decreases in the VAS scores with all three injections at all follow-up time points (p: 0.001 for the placebo group, p <0.001 for the LA group, and p <0.001 for the LA+CS group). When changes in VAS scores were compared between the groups, the LA+CS group demonstrated a higher decrease in VAS than the placebo group. Improvement in the PROM was seen only in the LA and LA+CS groups.
CONCLUSIONS


The findings of this study support the use of an SSNB with or without CS, to increase the range of motion in the affected shoulder, especially during the rehabilitation period.",2020,"There were significant decreases in the VAS scores with all three injections at all follow-up time points (p: 0.001 for the placebo group, p <0.001 for the LA group, and p <0.001 for the LA+CS group).","['patients with hemiplegic shoulder pain (HSP', 'hemiplegic patients', 'hemiplegic shoulder pain', '34 stroke patients with HSP']","['Suprascapular nerve block', 'SSNB', 'LA+CS', 'Localanesthetic (LA) injection into the trapezius muscle (placebo group), LA injection into thesuprascapular notch, and LA and corticosteroid (CS) injections into the suprascapularnotch', 'placebo, local anesthetic, and corticosteroid injections', 'placebo']","['visual analog scale (VAS) scores', 'PROM', 'pain intensity and passive range ofmotion (PROM', 'VAS', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205316', 'cui_str': 'Notched'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.235594,"There were significant decreases in the VAS scores with all three injections at all follow-up time points (p: 0.001 for the placebo group, p <0.001 for the LA group, and p <0.001 for the LA+CS group).","[{'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Terlemez', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Saglik Bilimleri University, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey. ranakaynar@hotmail.com.'}, {'ForeName': 'Selda', 'Initials': 'S', 'LastName': 'Çiftçi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Saglik Bilimleri University, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mahir', 'Initials': 'M', 'LastName': 'Topaloglu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mahir Topaloglu; MD. Koc University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Beril', 'Initials': 'B', 'LastName': 'Dogu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Saglik Bilimleri University, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Figen', 'Initials': 'F', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Saglik Bilimleri University, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Kuran', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Saglik Bilimleri University, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-020-04362-0']
58,32377773,Discoloration of surface sealants by plaque disclosing solution.,"PURPOSE


Surface sealants are widely used as a prevention strategy and are indicated for young patients with insufficient oral hygiene who also need plaque removal by professional tooth cleaning. The aim of this study was to evaluate discoloration of surface sealants by plaque disclosing solutions and to test to what extent this discoloration can be reduced again by professional tooth cleaning.
METHODS


In all, 96 extracted lesion-free human teeth were randomly assigned to treatment with either Pro Seal® (PS; Opal Orthodontics, South Jordan, UT, USA) or Opal®Seal™ (OS; Reliance Orthodontic Products, Itasca, IL, USA). Color evaluations after application of the plaque disclosing solution Mira-2-Ton® (Hager & Werken, Duisburg, Germany) were performed using a clinical spectrophotometer. Staining and polishing were repeated once. Color differences (∆E) above 3.77 were regarded as clinically relevant.
RESULTS


All sealants showed high, clinically relevant ∆E values after the first staining. Polishing led to significantly decreased ∆E values on PS-treated teeth; however, the median ∆E value remained above the clinically relevant threshold. Polishing on OS-treated teeth only slightly reduced ∆E values. After professional tooth cleaning both PS and OS showed clinically relevant ∆E values.
CONCLUSION


Surface sealants show clinically relevant discoloration after exposure to plaque disclosing solution under in vitro conditions. Such discolorations could not be removed by professional tooth cleaning. Thus, in clinical practice, plaque disclosing solutions might cause esthetic deficits in surface sealant-treated teeth. The impact of plaque disclosing solutions under clinical conditions (e.g., in the presence of saliva and by various aspects of a person's nutrition) should be investigated in clinical studies.",2020,"Polishing led to significantly decreased ∆E values on PS-treated teeth; however, the median ∆E value remained above the clinically relevant threshold.","['young patients with insufficient oral hygiene who also need plaque removal by professional tooth cleaning', '96 extracted lesion-free human teeth']","['Pro Seal® (PS; Opal Orthodontics, South Jordan, UT, USA) or Opal®Seal']",['∆E values'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C1570472', 'cui_str': 'Pro Seal'}, {'cui': 'C0084990', 'cui_str': 'VPDA protocol'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0036492', 'cui_str': 'Seal'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}]",96.0,0.0759057,"Polishing led to significantly decreased ∆E values on PS-treated teeth; however, the median ∆E value remained above the clinically relevant threshold.","[{'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Şen', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany. sinan.sen@med.uni-heidelberg.de.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Erber', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Gözde', 'Initials': 'G', 'LastName': 'Şen', 'Affiliation': 'MVZ Dentale Praxisklinik, Dr. Dilling & Kollegen GmbH, Fleiner Straße\xa03, 74072, Heilbronn, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Deurer', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Zingler', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lux', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}]",Journal of orofacial orthopedics = Fortschritte der Kieferorthopadie : Organ/official journal Deutsche Gesellschaft fur Kieferorthopadie,['10.1007/s00056-020-00227-5']
59,32377799,"A commentary on ""Effects of home-based stabilization exercises focusing on pelvic floor on postnatal stress urinary incontinence and low back pain: a randomized controlled trial"".",,2020,,['postnatal stress urinary incontinence and low back pain'],['home-based stabilization exercises'],[],"[{'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],,0.085299,,"[{'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Rostaminia', 'Affiliation': 'NorthShore University HealthSystem, Evanston, IL, USA. ghazalerostaminia@yahoo.com.'}]",International urogynecology journal,['10.1007/s00192-020-04321-5']
60,32379982,Effects of Exergames in Women with Fibromyalgia: A Randomized Controlled Study.,"Objective:  Evaluation of the effects of exergames in women with fibromyalgia on the impact of the disease-pain threshold and physical variables-compared to performing stretching exercises.  Materials and Methods:  Thirty-five women were enrolled in the study and divided by simple randomization into two treatment groups: the control group ( n  = 19) and the Wii™ (exergames) group ( n  = 16). Participants were evaluated using the fibromyalgia impact questionnaire (FIQ), algometry, step tests, cardiopulmonary parameters, and fatigue in the lower limbs. The participants underwent treatments for a period of 7 weeks with three 1-hour sessions weekly and were reevaluated after the 10th and the 20th sessions.  Results:  The exergames group showed significant reduction of their fibromyalgia symptoms, as demonstrated by lower FIQ scores in the key domains on questions regarding missed work, pain, fatigue, problems resting, stiffness, anxiety, and depression. Significant improvements were observed in mean algometric values in the cervical region, the second chondrocostal junction, the lateral epicondyle, left medial knee border, left occipital region, trapezius, supraspinatus, gluteal muscles, and the greater trochanter. Improved cardiovascular adaptation was reflected by decreased systolic blood pressure, reduction in fatigue of the lower limbs assessed by the CR10 Borg scale, and improved exercise capacity assessed by a step test.  Conclusion:  Exergames have the potential to increase exercise capacity, decrease the impact of fibromyalgia, promote cardiovascular adaptation, reduce fatigue of lower limbs, and improve the pain threshold in women with fibromyalgia.",2020,"The exergames group showed significant reduction of their fibromyalgia symptoms, as demonstrated by lower FIQ scores in the key domains on questions regarding missed work, pain, fatigue, problems resting, stiffness, anxiety, and depression.","['Women with Fibromyalgia', 'women with fibromyalgia', 'Materials and Methods:  Thirty-five women']",[],"['fibromyalgia symptoms', 'mean algometric values', 'Improved cardiovascular adaptation', 'systolic blood pressure, reduction in fatigue of the lower limbs assessed by the CR10 Borg scale, and improved exercise capacity', 'FIQ scores', 'questions regarding missed work, pain, fatigue, problems resting, stiffness, anxiety, and depression', 'fibromyalgia impact questionnaire (FIQ), algometry, step tests, cardiopulmonary parameters, and fatigue in the lower limbs', 'second chondrocostal junction, the lateral epicondyle, left medial knee border, left occipital region, trapezius, supraspinatus, gluteal muscles, and the greater trochanter']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319605', 'cui_str': '35'}]",[],"[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0449399', 'cui_str': 'Borg scale'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1283330', 'cui_str': 'Absenteeism at work'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0222681', 'cui_str': 'Structure of epicondyle'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0028785', 'cui_str': 'Occipital lobe structure'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0584869', 'cui_str': 'Supraspinatus muscle structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0223865', 'cui_str': 'Structure of greater trochanter of femur'}]",35.0,0.0598946,"The exergames group showed significant reduction of their fibromyalgia symptoms, as demonstrated by lower FIQ scores in the key domains on questions regarding missed work, pain, fatigue, problems resting, stiffness, anxiety, and depression.","[{'ForeName': 'Marcelo Silva de', 'Initials': 'MS', 'LastName': 'Carvalho', 'Affiliation': 'Bioscience Program, Federal University of Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Leonardo Cesar', 'Initials': 'LC', 'LastName': 'Carvalho', 'Affiliation': 'Bioscience Program, Federal University of Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Flavia da Silva', 'Initials': 'FDS', 'LastName': 'Menezes', 'Affiliation': 'Science Rehabilitation Program, Federal University of Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Andressa', 'Initials': 'A', 'LastName': 'Frazin', 'Affiliation': 'Graduate of Physical Therapy Faculty, Federal University of Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Elenara da Costa', 'Initials': 'EDC', 'LastName': 'Gomes', 'Affiliation': 'Graduate of Physical Therapy Faculty, Federal University of Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Denise Hollanda', 'Initials': 'DH', 'LastName': 'Iunes', 'Affiliation': 'Science Rehabilitation Program, Federal University of Alfenas, Alfenas, Brazil.'}]",Games for health journal,['10.1089/g4h.2019.0108']
61,32386065,Stereoselective Steady-State Disposition and Bioequivalence of Brand and Generic Bupropion in Adults.,"The antidepressant bupropion is stereoselectively metabolized and metabolite enantiomers have differential pharmacologic effects, but steady-state enantiomeric disposition is unknown. Controversy persists about bupropion XL 300 mg generic equivalence to brand product, and whether generics might have different stereoselective disposition leading to enantiomeric non-bioequivalence and, thus, clinical nonequivalence. This preplanned follow-on analysis of a prospective, randomized, double-blinded, crossover study of brand and 3 generic bupropion XL 300 mg products measured steady-state enantiomeric plasma and urine parent bupropion and primary and secondary metabolite concentrations and evaluated bioequivalence and pharmacokinetics. Steady-state plasma and urine bupropion disposition was markedly stereoselective, with up to 40-fold differences in plasma concentrations of the active metabolite S,S-hydroxybupropion vs. R,R,-hydroxybupropion. Urine metabolite glucuronides were prominent, but glucuronidation was metabolite-specific and enantioselective. There were no differences between any generic and brand, or between generics, in plasma enantiomer concentrations of bupropion or the major metabolites. All generic products satisfied formal bioequivalence criteria (peak plasma concentration (C max  ) and area under the plasma concentration-time curve over 24 hours (AUC 0-24  )) using enantiomers for bupropion as well as for metabolites, and generics were comparable to each other, and were considered bioequivalent, based on enantiomeric analysis. Enantiomeric bioequivalence explains the previously observed therapeutic equivalence of bupropion generics and brand in treating major depression. These results have important implications for understanding the clinical therapeutic effects of bupropion based on complex and stereoselective metabolism.",2020,"All generic products satisfied formal bioequivalence criteria (C max  and AUC 0-24  ) using enantiomers for bupropion as well as for metabolites, and generics were comparable to each other, and were considered bioequivalent, based on enantiomeric analysis.",['adults'],"['bupropion', 'brand and three generic bupropion XL300']","['steady-state enantiomeric plasma and urine parent bupropion and primary and secondary metabolite concentrations and evaluated bioequivalence and pharmacokinetics', 'Steady-state plasma and urine bupropion disposition', 'Urine metabolite glucuronides']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}]","[{'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}]",,0.0306987,"All generic products satisfied formal bioequivalence criteria (C max  and AUC 0-24  ) using enantiomers for bupropion as well as for metabolites, and generics were comparable to each other, and were considered bioequivalent, based on enantiomeric analysis.","[{'ForeName': 'Evan D', 'Initials': 'ED', 'LastName': 'Kharasch', 'Affiliation': 'Department of Anesthesiology, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Neiner', 'Affiliation': 'Department of Anesthesiology, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Kraus', 'Affiliation': 'Department of Anesthesiology, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Blood', 'Affiliation': 'Department of Anesthesiology, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Stevens', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Division of Biostatistics, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1888']
62,32388179,Do menopausal status and APOE4 genotype alter the long-term effects of intensive lifestyle intervention on cognitive function in women with type 2 diabetes mellitus?,"In the Look AHEAD trial, randomization to Intensive Lifestyle Intervention (ILI) or Diabetes Support and Education (DSE) did not result in differences in cognitive outcomes. However, menopause and APOE genotype are factors that affect the response to this intervention. The effect of this intervention on a single cognitive assessment was examined in 3 groups of women: premenopausal or <5 years postmenopausal (N = 594), within 5-10 years (n = 388), and ≥10 years postmenopausal (n = 963), and as a function of continuous years since menopause. The late postmenopausal group in the ILI had worse composite z-scores compared to those in the DSE, whereas the younger premenopausal or early postmenopausal women in the ILI had better composite z-scores than the DSE. A significant interaction between years since menopause and intervention arm, but not baseline age, was observed on executive function domains. ILI appeared only to benefit cognitive function among non-APOE4 carriers during premenopause or early postmenopause. These findings emphasize the importance of assessing menopause and APOE status to understand how weight loss impacts cognition.",2020,ILI appeared only to benefit cognitive function among non-APOE4 carriers during premenopause or early postmenopause.,"['women with type 2 diabetes mellitus', '3 groups of women: premenopausal or <5\xa0years postmenopausal (N\xa0= 594), within 5-10\xa0years (n\xa0= 388), and ≥10\xa0years postmenopausal (n\xa0= 963), and as a function of continuous years since menopause']","['Intensive Lifestyle Intervention (ILI) or Diabetes Support and Education (DSE', 'intensive lifestyle intervention']","['cognitive function', 'composite z-scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",,0.020602,ILI appeared only to benefit cognitive function among non-APOE4 carriers during premenopause or early postmenopause.,"[{'ForeName': 'Hussein N', 'Initials': 'HN', 'LastName': 'Yassine', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. Electronic address: hyassine@usc.edu.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Brinton', 'Affiliation': 'Departments of Pharmacology and Neurology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Carmichael', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Hoscheidt', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Christina E', 'Initials': 'CE', 'LastName': 'Hugenschmidt', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Keller', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}]",Neurobiology of aging,['10.1016/j.neurobiolaging.2020.03.020']
63,32396409,"A Prospective Randomized Controlled Trial of Irrigation ""Bag Squeeze"" to Manage Pain for Patients Undergoing Flexible Cystoscopy.","PURPOSE


We determined if the ""bag squeeze"" technique decreases pain during flexible cystoscopy in men.
MATERIALS AND METHODS


This single center, prospective, double-blind, randomized controlled trial recruited 200 consenting participants who were ambulatory, outpatient males who had undergone prior cystoscopy and were not expected to require any secondary procedures. Men with prior urethral stricture or bladder neck contracture were excluded from study. Once eligibility was assessed and consent obtained, participants were randomized to undergo cystoscopy with the bag squeeze (group A) or the sham bag squeeze procedure (group B). Following cystoscopy, participants completed a pain questionnaire (visual analogue scale). Differences in mean pain score between groups were evaluated using Students' t-test with a 2-sided alpha of 0.05.
RESULTS


A total of 200 patients were randomized and underwent flexible cystoscopy. Ten participants were ineligible because they required secondary procedures. Among the 190 eligible patients 97 were randomized to bag squeeze (group A) and 93 to sham bag squeeze (group B) with mean pain scores of 1.91 and 3.39, respectively (p <0.005).
CONCLUSIONS


This study demonstrated a clinically meaningful decrease in pain for men undergoing flexible cystoscopy when the irrigation bag squeeze technique was used vs placebo bag squeeze. Accordingly, this useful, simple and free method to improve patient comfort during flexible cystoscopy should be adopted by clinicians.",2020,"This study demonstrated a clinically meaningful decrease in pain for men undergoing flexible cystoscopy when the irrigation ""bag-squeeze"" technique was employed versus placebo bag-squeeze.","['Ten participants were ineligible because they required secondary procedures', 'Two hundred patients', 'Patients Undergoing Flexible Cystoscopy', '200 consenting participants who were ambulatory, outpatient males who had undergone a prior cystoscopy and were not expected to require any secondary procedures', '190 eligible patients, 97 were randomized to', 'men', 'Men with prior urethral stricture or bladder neck contracture']","['bag-squeeze', 'flexible cystoscopy', 'Irrigation ""Bag Squeeze', 'bag-squeeze"" technique', 'cystoscopy with the ""bag-squeeze"" (group A) or the sham bag-squeeze procedure', 'irrigation bag during a flexible cystoscopy']","['mean pain score', 'pain questionnaire: visual analogue scale', 'pain perception', 'pain']","[{'cui': 'C0445275', 'cui_str': 'Secondary procedure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0577992', 'cui_str': 'Flexible cystoscopy'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}, {'cui': 'C0542404', 'cui_str': 'Stenosis of bladder neck'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0577992', 'cui_str': 'Flexible cystoscopy'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",200.0,0.261447,"This study demonstrated a clinically meaningful decrease in pain for men undergoing flexible cystoscopy when the irrigation ""bag-squeeze"" technique was employed versus placebo bag-squeeze.","[{'ForeName': 'Mohamad Baker', 'Initials': 'MB', 'LastName': 'Berajoui', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ishan', 'Initials': 'I', 'LastName': 'Aditya', 'Affiliation': 'University of Toronto, School of Medicine, Toronto, Ontario, Canada.'}, {'ForeName': 'JaimeOmar', 'Initials': 'J', 'LastName': 'Herrera-Caceres', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Yazan', 'Initials': 'Y', 'LastName': 'Qaoud', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Lajkosz', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Ajib', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Glase', 'Affiliation': 'Department of Neurosciences, Carleton University, Ottawa, Ontario, Canada.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hersey', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Miran', 'Initials': 'M', 'LastName': 'Kenk', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hamilton', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Girish S', 'Initials': 'GS', 'LastName': 'Kulkarni', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alexandre R', 'Initials': 'AR', 'LastName': 'Zlotta', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jason Y', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Perlis', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Finelli', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Neil E', 'Initials': 'NE', 'LastName': 'Fleshner', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}]",The Journal of urology,['10.1097/JU.0000000000001139']
64,32338067,Glycine Max (L.)  Merr isoflavone gel improves vaginal vascularization in postmenopausal women.,"Objective:  This study aimed to analyze the effects of isoflavones from  Glycine max (L.)  Merr (soy) used topically as a vaginal gel on the induction of vascularization of the vaginal tissue in postmenopausal women. Study design:  A placebo-controlled, randomized, double-blind trial was conducted with 22 postmenopausal women, randomly allocated for treatment with  Glycine max (L.)  Merr isoflavone 4% vaginal gel daily for 12 weeks or with placebo gel for the same period. Main outcome measure:  Vaginal microbiopsies were collected before and after the 12-week treatment. Immunohistochemistry analyses were performed to provide a blood vessel count per field in the vaginal tissue, pre and post intervention. Results:  The isoflavone group exhibited a significant increase in blood vessels per field relative to baseline, whereas the placebo group showed no difference compared to baseline. There was a significant difference in the increase of the number of blood vessels between the isoflavone and placebo groups. Conclusion:  The results showed that local administration of  Glycine max (L.)  Merr isoflavone gel promoted a significant improvement in the number of blood vessels in the vaginal tissue of postmenopausal women.",2020,There was a significant difference in the increase of the number of blood vessels between the isoflavone and placebo groups.,"['22 postmenopausal women', 'postmenopausal women']","['isoflavone', 'placebo', 'Glycine Max (L.)  Merr isoflavone gel', 'Glycine max (L.)  Merr isoflavone gel', 'isoflavones from  Glycine max (L.)  Merr (soy', 'Glycine max (L.)  Merr isoflavone 4% vaginal gel daily for 12\u2009weeks or with placebo gel']","['Vaginal microbiopsies', 'number of blood vessels', 'blood vessels']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0042257', 'cui_str': 'Vaginal gel'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]",22.0,0.334028,There was a significant difference in the increase of the number of blood vessels between the isoflavone and placebo groups.,"[{'ForeName': 'S M R R', 'Initials': 'SMRR', 'LastName': 'Lima', 'Affiliation': 'Endocrine Gynecology and Climacteric Department, Irmandade Santa Casa de Misericórdia de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Honorato', 'Affiliation': 'Endocrine Gynecology and Climacteric Department, Irmandade Santa Casa de Misericórdia de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'M A L G', 'Initials': 'MALG', 'LastName': 'Silva', 'Affiliation': 'Department of Pathology, Irmandade Santa Casa de Misericórdia de São Paulo, São Paulo, Brazil.'}]",Climacteric : the journal of the International Menopause Society,['10.1080/13697137.2020.1752172']
65,32376981,Longitudinal follow-up after telephone disclosure in the randomized COGENT study.,"PURPOSE


To better understand the longitudinal risks and benefits of telephone disclosure of genetic test results in the era of multigene panel testing.
METHODS


Adults who were proceeding with germline cancer genetic testing were randomized to telephone disclosure (TD) with a genetic counselor or in-person disclosure (IPD) (i.e., usual care) of test results. All participants who received TD were recommended to return to meet with a physician to discuss medical management recommendations.
RESULTS


Four hundred seventy-three participants were randomized to TD and 497 to IPD. There were no differences between arms for any cognitive, affective, or behavioral outcomes at 6 and 12 months. Only 50% of participants in the TD arm returned for the medical follow-up appointment. Returning was associated with site (p < 0.0001), being female (p = 0.047), and not having a true negative result (p < 0.002). Mammography was lower at 12 months among those who had TD and did not return for medical follow-up (70%) compared with those who had TD and returned (86%) and those who had IPD (87%, adjusted p < 0.01).
CONCLUSION


Telephone disclosure of genetic test results is a reasonable alternative to in-person disclosure, but attention to medical follow-up may remain important for optimizing appropriate use of genetic results.",2020,"Returning was associated with site (p < 0.0001), being female (p = 0.047), and not having a true negative result (p < 0.002).","['Four hundred seventy-three participants were randomized to TD and 497 to IPD', 'Adults who were proceeding with germline cancer genetic testing']","['telephone disclosure (TD) with a genetic counselor or in-person disclosure (IPD)\xa0(i.e., usual care']","['cognitive, affective, or behavioral outcomes', 'Mammography']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0587719', 'cui_str': 'Genetic counselor'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}]",473.0,0.0669023,"Returning was associated with site (p < 0.0001), being female (p = 0.047), and not having a true negative result (p < 0.002).","[{'ForeName': 'Madison K', 'Initials': 'MK', 'LastName': 'Kilbride', 'Affiliation': 'Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Egleston', 'Affiliation': 'Fox Chase Cancer Center, Temple University Health System, Biostatistics and Bioinformatics Facility, Philadelphia, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hall', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Patrick-Miller', 'Affiliation': 'Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Daly', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Ganschow', 'Affiliation': 'Department of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Generosa', 'Initials': 'G', 'LastName': 'Grana', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Olufunmilayo I', 'Initials': 'OI', 'LastName': 'Olopade', 'Affiliation': 'Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Fetzer', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Brandt', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Chambers', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Dana F', 'Initials': 'DF', 'LastName': 'Clark', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Forman', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Rikki', 'Initials': 'R', 'LastName': 'Gaber', 'Affiliation': 'Department of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Gulden', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Horte', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Long', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Terra', 'Initials': 'T', 'LastName': 'Lucas', 'Affiliation': 'Department of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Shreshtha', 'Initials': 'S', 'LastName': 'Madaan', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Mattie', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McKenna', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Montgomery', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nielsen', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Powers', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Rainey', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Rybak', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Savage', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Seelaus', 'Affiliation': 'Department of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Stoll', 'Affiliation': 'Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jill E', 'Initials': 'JE', 'LastName': 'Stopfer', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Xinxin Shirley', 'Initials': 'XS', 'LastName': 'Yao', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Domchek', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Angela R', 'Initials': 'AR', 'LastName': 'Bradbury', 'Affiliation': 'Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA, USA. Angela.Bradbury@uphs.upenn.edu.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-020-0808-3']
66,32379687,Effect of oral consumption of vitamin D on uterine fibroids: A randomized clinical trial.,"BACKGROUND


and purpose: Uterine fibroids are common tumors of the female reproductive system. Symptomatic uterine fibroids require surgical or medical therapy depending on the severity of the symptoms. This study was conducted to investigate the effect of vitamin D on uterine fibroids.
MATERIALS AND METHODS


A randomized clinical trial was conducted from June to November 2018. Eligible women were randomly assigned to receive vitamin D or a placebo for 12 weeks. The change in the volume of fibroids was considered to be the main variable in the efficacy evaluation.
RESULTS


No statistically significant decrease in the volume of fibroids was observed in the experimental group [mean difference (MD): -0.71, 95% confidence interval (CI): -0.1 to 1.53, P = 0.085], and a significant increase was observed in the size of fibroids in the control group (MD: 2.53, 95% CI: 1.9 to 4.05, p = 0.001).
CONCLUSION


Vitamin D consumption might inhibit growth of uterine fibroids; however, the long-term effects remain unclear.",2020,No statistically significant decrease in the volume of fibroids was observed in the experimental group [mean difference (MD): -0.71,"['June to November 2018', 'Eligible women', 'uterine fibroids']","['oral consumption of vitamin D', 'vitamin D', 'Vitamin D consumption', 'placebo']","['volume of fibroids', 'size of fibroids']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.370172,No statistically significant decrease in the volume of fibroids was observed in the experimental group [mean difference (MD): -0.71,"[{'ForeName': 'Somayye', 'Initials': 'S', 'LastName': 'Arjeh', 'Affiliation': 'Fertility and Infertility Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Darsareh', 'Affiliation': 'Mother and Child Welfare Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Zhila Abedi', 'Initials': 'ZA', 'LastName': 'Asl', 'Affiliation': 'Fertility and Infertility Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Azizi Kutenaei', 'Affiliation': 'Fertility and Infertility Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. Electronic address: Maryamazizikut86@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101159']
67,32379690,"Feasibility and effect of a Pilates program on the clinical, physical and sleep parameters of adolescents with anorexia nervosa.","BACKGROUND AND PURPOSE


Anorexia nervosa (AN) becomes chronic, with high physical, psychological and social morbidity and high mortality without early and effective treatment. The impact of physical exercise as a coadjutant to conventional treatment in this clinical population has been studied with favorable results. Although a Pilates program could be beneficial for patients with AN, no study has analyzed its feasibility and effects in adolescents with AN. Therefore, this study evaluated the safety of a Pilates program and investigated the feasibility and effect in adolescents with AN.
MATERIALS AND METHODS


In this prospective quasi-experimental study, body composition, blood analysis, sedentary time, physical activity and time of sleep, and physical fitness were measured objectively before and after a 10-week Pilates supervised program.
RESULTS


Twelve female adolescents with AN (14.6 ± 1.7 years old) completed the program, with a session attendance rate of 96%, a persistence rate of 100%. There were significant increases in height, plasma calcium and sleep efficiency. Significant decreases in plasma follitropin, sleep duration and, duration and number of night perturbations were observed.
CONCLUSION


A Pilates program is safe and feasible in adolescents with AN when they have a controlled and stable weight, and such a program could be a viable alternative among treatment programs to achieve better sleep quality.",2020,"Significant decreases in plasma follitropin, sleep duration and, duration and number of night perturbations were observed.
","['Twelve female adolescents with AN (14.6\xa0±\xa01.7 years old', 'adolescents with AN', 'adolescents with anorexia nervosa']","['Pilates program', 'physical exercise']","['height, plasma calcium and sleep efficiency', 'body composition, blood analysis, sedentary time, physical activity and time of sleep, and physical fitness', 'plasma follitropin, sleep duration and, duration and number of night perturbations']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1272114', 'cui_str': 'Plasma calcium level'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]",12.0,0.0123061,"Significant decreases in plasma follitropin, sleep duration and, duration and number of night perturbations were observed.
","[{'ForeName': 'Sofía M', 'Initials': 'SM', 'LastName': 'Martínez-Sánchez', 'Affiliation': 'Department of Sports and Computer Science, Section of Physical Education and Sports, Faculty of Sports Sciences, Universidad Pablo de Olavide, Seville, Spain. Electronic address: sofiams91@gmail.com.'}, {'ForeName': 'Tomás E', 'Initials': 'TE', 'LastName': 'Martínez-García', 'Affiliation': 'Department of Internal Medicine, Juan Ramón Jiménez Hospital, Huelva, Spain. Electronic address: teugenio.martinez.sspa@juntadeandalucia.es.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bueno-Antequera', 'Affiliation': 'Physical Performance Sports Research Center, Department of Sports and Computer Science, Section of Physical Education and Sports, Faculty of Sports Sciences, Universidad Pablo de Olavide, Seville, Spain. Electronic address: jbueant@upo.es.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Munguía-Izquierdo', 'Affiliation': 'Physical Performance Sports Research Center, Department of Sports and Computer Science, Section of Physical Education and Sports, Faculty of Sports Sciences, Universidad Pablo de Olavide, Seville, Spain; Biomedical Research Networking Center on Frailty and Healthy Aging, Madrid, Spain. Electronic address: dmunizq@upo.es.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101161']
68,32380893,Optimal individualized decision rules from a multi-arm trial: A comparison of methods and an application to tailoring inter-donation intervals among blood donors in the UK.,"There is a growing interest in precision medicine where individual heterogeneity is incorporated into decision-making and treatments are tailored to individuals to provide better healthcare. One important aspect of precision medicine is the estimation of the optimal individualized treatment rule (ITR) that optimizes the expected outcome. Most methods developed for this purpose are restricted to the setting with two treatments, while clinical studies with more than two treatments are common in practice. In this work, we summarize methods to estimate the optimal ITR in the multi-arm setting and compare their performance in large-scale clinical trials via simulation studies. We then illustrate their utilities with a case study using the data from the INTERVAL trial, which randomly assigned over 20,000 male blood donors from England to one of the three inter-donation intervals (12-week, 10-week, and eight-week) over two years. We estimate the optimal individualized donation strategies under three different objectives. Our findings are fairly consistent across five different approaches that are applied: when we target the maximization of the total units of blood collected, almost all donors are assigned to the eight-week inter-donation interval, whereas if we aim at minimizing the low hemoglobin deferral rates, almost all donors are assigned to donate every 12 weeks. However, when the goal is to maximize the utility score that ""discounts"" the total units of blood collected by the incidences of low hemoglobin deferrals, we observe some heterogeneity in the optimal inter-donation interval across donors and the optimal donor assignment strategy is highly dependent on the trade-off parameter in the utility function.",2020,There is a growing interest in precision medicine where individual heterogeneity is incorporated into decision-making and treatments are tailored to individuals to provide better healthcare.,"['blood donors in the UK', '20,000 male blood donors from England to one of the three inter-donation intervals (12-week, 10-week, and eight-week) over two\u2009years']",[],[],"[{'cui': 'C0005795', 'cui_str': 'Blood donor'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],[],20000.0,0.0385396,There is a growing interest in precision medicine where individual heterogeneity is incorporated into decision-making and treatments are tailored to individuals to provide better healthcare.,"[{'ForeName': 'Yuejia', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'MRC Biostatistics Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Wood', 'Affiliation': 'Cardiovascular Epidemiology Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sweeting', 'Affiliation': 'Cardiovascular Epidemiology Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Roberts', 'Affiliation': 'BRC Haematology Theme and Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Brian Dm', 'Initials': 'BD', 'LastName': 'Tom', 'Affiliation': 'MRC Biostatistics Unit, University of Cambridge, Cambridge, UK.'}]",Statistical methods in medical research,['10.1177/0962280220920669']
69,32384147,Impact of arginine therapy on mitochondrial function in children with sickle cell disease during vaso-occlusive pain.,"Altered mitochondrial function occurs in sickle cell disease (SCD), due in part to low nitric oxide (NO) bioavailability. Arginine, the substrate for NO production, becomes acutely deficient in SCD patients with vaso-occlusive pain episodes (VOE). To determine if arginine improves mitochondrial function, 12 children with SCD-VOE (13.6 ± 3 years; 67% male; 75% hemoglobin-SS) were randomized to 1 of 3 arginine doses: (1) 100 mg/kg IV 3 times/day (TID); (2) loading dose (200 mg/kg) then 100 mg/kg TID; or (3) loading dose (200 mg/kg) followed by continuous infusion (300 mg/kg per day) until discharge. Platelet-rich plasma mitochondrial activity, protein expression, and protein-carbonyls were measured from emergency department (ED) presentation vs discharge. All VOE subjects at ED presentation had significantly decreased complex-V activity compared to a steady-state cohort. Notably, complex-V activity was increased at discharge in subjects from all 3 arginine-dosing schemes; greatest increase occurred with a loading dose (P < .001). Although complex-IV and citrate synthase activities were similar in VOE platelets vs steady state, enzyme activities were significantly increased in VOE subjects after arginine-loading dose treatment. Arginine also decreased protein-carbonyl levels across all treatment doses (P < .01), suggesting a decrease in oxidative stress. Arginine therapy increases mitochondrial activity and reduces oxidative stress in children with SCD/VOE. This trial was registered at www.clinicaltrials.gov as #NCT02536170.",2020,"Arginine therapy also decreased protein-carbonyl levels across all treatment doses (p<0.01), suggesting a decrease in oxidative stress.","['Children with Sickle Cell Disease during Vaso-occlusive Pain', 'sickle cell disease (SCD', 'children with SCD/VOE', 'SCD patients with vaso-occlusive-painful-events (VOE', '12 children with SCD hospitalized for VOE (age 13.6±3 years, 67% male, 75% HbSS']","['arginine therapy', 'Arginine therapy', 'arginine', 'Arginine Therapy']","['mitochondrial activity', 'oxidative stress', 'complex-V activity', 'protein-carbonyl levels', 'Platelet-rich-plasma mitochondrial activity, protein expression, and protein-carbonyls', 'Mitochondrial Function', 'VOE platelets vs. steady state, enzyme activities']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0069436', 'cui_str': 'oligomycin sensitivity-conferring protein'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}]",12.0,0.0192241,"Arginine therapy also decreased protein-carbonyl levels across all treatment doses (p<0.01), suggesting a decrease in oxidative stress.","[{'ForeName': 'Claudia R', 'Initials': 'CR', 'LastName': 'Morris', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Lou Ann S', 'Initials': 'LAS', 'LastName': 'Brown', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Reynolds', 'Affiliation': 'Department of Pharmacology & Chemical Biology, Vascular Medicine Institute, Center for Metabolism & Mitochondrial Medicine (C3M), University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Carlton D', 'Initials': 'CD', 'LastName': 'Dampier', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Lane', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Watt', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, GA; and.""}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Kumari', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Harris', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Shaminy', 'Initials': 'S', 'LastName': 'Manoranjithan', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, GA; and.""}, {'ForeName': 'Reshika D', 'Initials': 'RD', 'LastName': 'Mendis', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, GA; and.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Figueroa', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Sruti', 'Initials': 'S', 'LastName': 'Shiva', 'Affiliation': 'Department of Pharmacology & Chemical Biology, Vascular Medicine Institute, Center for Metabolism & Mitochondrial Medicine (C3M), University of Pittsburgh, Pittsburgh, PA.'}]",Blood,['10.1182/blood.2019003672']
70,32385846,A Randomized Controlled Trial with a Medical Device Containing Sodium Hyaluronate and Nicotinic Acid to Increase the Efficacy of Ultraviolet Phototherapy in Psoriasis.,"INTRODUCTION


The dry and scaly skin of psoriatic patients decreases the efficacy of ultraviolet B (UVB) phototherapy. Different agents are used to facilitate the transmission of light, but most of these preparations are cosmetically unfavorable. We have tested a novel preparation containing sodium hyaluronate and nicotinic acid (UV Fotogel®; Pernix Ltd.) with the double aim to improve the efficacy of UVB phototherapy and assess the cosmetic acceptability of the preparation.
METHODS


Ninety patients with plaque psoriasis were enrolled in the study, of whom 44 received narrow-band UVB (NB-UVB) phototherapy. Prior to phototherapy, one side of the patient's body was treated with UV Fotogel while the other side served as a control. The other 46 patients used the preparation at their homes before regular sunbathing. The Local Psoriasis Severity Index (L-PSI), cosmetic acceptability and tolerability were recorded. The median values with the 25th and 75th percentiles (25p and 75p, respectively) were determined for the UV Fotogel-treated and control sites and then compared.
RESULTS


The sides of the body to which UV Fotogel was applied prior to NB-UVB phototherapy had a significantly lower median L-PSI score than the non-treated control sides at the end of the treatment (1.0 [25p-75p: 0.0-2.0] vs. 2.0 [1.0-3.0], respectively). The application of UV Fotogel prior to sunbathing also led to a significant decrease in L-PSI score. There was a significant reduction in the median L-PSI score of patients at the final visit compared to baseline (2.5 [25p-75p: 1.5-3.5] vs. 6.0 [6.0-7.0], respectively). Use of the preparation was not accompanied by considerable adverse effects, and the patients found it cosmetically acceptable. Application of UV Fotogel prior to sunbathing was well tolerated by the patients, and the cosmetic acceptability was also good.
CONCLUSION


UV Fotogel is potentially a useful device for enhancement of the efficacy of phototherapy in patients with psoriasis.",2020,The application of UV Fotogel prior to sunbathing also led to a significant decrease in L-PSI score.,"['patients with psoriasis', '46 patients used the preparation at their homes before regular sunbathing', 'Ninety patients with plaque psoriasis were enrolled in the study, of whom 44 received', 'psoriatic patients', 'Psoriasis']","['narrow-band UVB (NB-UVB) phototherapy', 'ultraviolet B (UVB) phototherapy', 'Ultraviolet Phototherapy', 'UVB phototherapy', 'Medical Device Containing Sodium Hyaluronate and Nicotinic Acid']","['median L-PSI score', 'cosmetic acceptability', 'Local Psoriasis Severity Index (L-PSI), cosmetic acceptability and tolerability', 'L-PSI score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038813', 'cui_str': 'Sunbathing'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",90.0,0.0219961,The application of UV Fotogel prior to sunbathing also led to a significant decrease in L-PSI score.,"[{'ForeName': 'Balázs', 'Initials': 'B', 'LastName': 'Bende', 'Affiliation': 'Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Róbert', 'Initials': 'R', 'LastName': 'Kui', 'Affiliation': 'Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Annamária', 'Initials': 'A', 'LastName': 'Németh', 'Affiliation': 'Clinical Research Coordination Centre, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Mariann', 'Initials': 'M', 'LastName': 'Borsos', 'Affiliation': 'Adware Research Ltd., Balatonfüred, Hungary.'}, {'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Tóbiás', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Erős', 'Affiliation': 'Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary. eros.gabor@med.u-szeged.hu.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Kemény', 'Affiliation': 'Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Baltás', 'Affiliation': 'Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary.'}]",Dermatology and therapy,['10.1007/s13555-020-00385-9']
71,32335086,A Novel Perineal Nerve Block Approach for Transperineal Prostate Biopsy: An Anatomical Analysis-based Randomized Single-blind Controlled Trial.,"OBJECTIVE


To develop and validate a novel perineal nerve block approach for transperineal prostate biopsy.
PATIENTS AND METHODS


Five adult male cadavers were dissected to delineate the superficial and deep branches of the perineal nerve. Afterwards, 90 out of 115 patients were selected and randomly assigned to receive periprostatic, periapical triangle, or branches of perineal nerve (BPN) block. The primary outcome was the maximal pain intensity associated with transperineal prostate biopsy, which was assessed by the 10-point visual analog scale. The secondary outcomes included the number of biopsy with visual analog scale of ≥4 in each biopsy procedure, and the incidences of complications.
RESULTS


On the horizontal line of the upper anal border, the locations of the superficial branch of perineal nerve on the left and right sides were 1.87 ± 0.05 cm and 1.86 ± 0.06 cm, respectively; and the deep branch were 2.15 ± 0.07 cm and 2.16 ± 0.06 cm, respectively, from the midline, and lied between the deep layer of superficial fascia and prostate capsule. The number of cases finally enrolled in data analysis in periprostatic block, periapical triangle block, and BPN block groups were 26, 27, and 30, respectively. The maximal pain intensities were 3.4 (3.1-3.7), 3.3 (3.0-3.6), and 1.8 (1.5-2.2) in the 3 groups, respectively, and the numbers of biopsy with the pain intensity of ≥4 were 4.0 (3.2-4.9), 4.2 (3.3-5.2), and 0.7 (0.1-1.2), respectively. There were 4, 3 and 4 cases developing hematuria, and 1, 1 and 2 burdened with urine retention after biopsy in the 3 groups, respectively.
CONCLUSION


Collectively, BPN block is a safe, effective and repeatable local anesthesia approach for transperineal prostate biopsy.",2020,"Collectively, BPN block is a safe, effective and repeatable local anesthesia approach for transperineal prostate biopsy.","['Five adult male cadavers', '90 out of 115 patients']","['Transperineal Prostate Biopsy', 'periprostatic, periapical triangle (PAT), or branches of perineal nerve (BPN) block', 'Novel Perineal Nerve Block Approach']","['maximal pain intensities', 'urine retention', 'numbers of biopsy with the pain intensity', 'maximal pain intensity associated with transperineal prostate biopsy, which was assessed by the 10-point VAS', 'number of biopsy with VAS of >=4 in each biopsy procedure, and the incidences of complications']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0006629', 'cui_str': 'Cadaver'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205500', 'cui_str': 'Perineal approach'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0228961', 'cui_str': 'Structure of perineal nerve'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0449807', 'cui_str': 'Number of biopsies'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205500', 'cui_str': 'Perineal approach'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",115.0,0.107247,"Collectively, BPN block is a safe, effective and repeatable local anesthesia approach for transperineal prostate biopsy.","[{'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Hengzhi', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Biming', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Department of Urology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Anatomy, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Xi', 'Affiliation': 'Department of Anesthesiology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Anatomy, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Husheng', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Guangan', 'Initials': 'G', 'LastName': 'Xiao', 'Affiliation': 'Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Maoyu', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Zhenkai', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Sheng', 'Affiliation': 'Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Chuanliang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Yinghao', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China. Electronic address: 446720864@qq.com.'}]",Urology,['10.1016/j.urology.2020.01.058']
72,32382714,"A phase 1b randomized study of the safety and immunological responses to vaccination with H4:IC31, H56:IC31, and BCG revaccination in  Mycobacterium tuberculosis -uninfected adolescents in Cape Town, South Africa.","Background


Tuberculosis (TB) remains the leading cause of infectious disease-related death. Recently, a trial of BCG revaccination and vaccination with H4:IC31, a recombinant protein vaccine, in South African adolescents (Aeras C-040-404) showed efficacy in preventing sustained QuantiFERON (QFT) conversion, a proxy for  Mycobacterium tuberculosis  ( M.tb ) infection. A phase 1b trial of 84 South African adolescents was conducted, concurrent with Aeras C-040-404, to assess the safety and immunogenicity of H4:IC31, H56:IC31 and BCG revaccination, and to identify and optimize immune assays for identification of candidate correlates of protection in efficacy trials.
Methods


Two doses of H4:IC31 and H56:IC31 vaccines were administered intramuscularly (IM) 56 days apart, and a single dose of BCG (2-8 × 10 5  CFU) was administered intradermally (ID). T-cell and antibody responses were measured using intracellular cytokine staining and binding antibody assays, respectively. Binding antibodies and CD4+/CD8+ T-cell responses to H4- and H56-matched antigens were measured in samples from all participants. The study was designed to characterize safety and immunogenicity and was not powered for group comparisons. (Clinicaltrials.gov NCT02378207).
Findings


In total, 481 adolescents (mean age 13·9 years) were screened; 84 were enrolled (54% female). The vaccines were generally safe and well-tolerated, with no reported severe adverse events related to the study vaccines. H4:IC31 and H56:IC31 elicited CD4+ T cells recognizing vaccine-matched antigens and H4- and H56-specific IgG binding antibodies. The highest vaccine-induced CD4+ T-cell response rates were for those recognizing Ag85B in the H4:IC31 and H56:IC31 vaccinated groups. BCG revaccination elicited robust, polyfunctional BCG-specific CD4+ T cells, with no increase in H4- or H56-specific IgG binding antibodies. There were few antigen-specific CD8+ T-cell responses detected in any group.
Interpretation


BCG revaccination administered as a single dose ID and both H4:IC31 and H56:IC31 administered as 2 doses IM had acceptable safety profiles in healthy, QFT-negative, previously BCG-vaccinated adolescents. Characterization of the assays and the immunogenicity of these vaccines may help to identify valuable markers of protection for upcoming immune correlates analyses of C-040-404 and future TB vaccine efficacy trials.
Funding


NIAID and Aeras.",2020,H4:IC31 and H56:IC31 elicited CD4+ T cells recognizing vaccine-matched antigens and H4- and H56-specific IgG binding antibodies.,"['Mycobacterium tuberculosis -uninfected adolescents in Cape Town, South Africa', '84 South African adolescents', 'South African adolescents', '481 adolescents (mean age 13·9 years) were screened; 84 were enrolled (54% female']","['H4:IC31, H56:IC31, and BCG revaccination', 'H4:IC31 and H56:IC31 vaccines', 'H4:IC31 and H56:IC31', 'H4:IC31, a recombinant protein vaccine']","['antigen-specific CD8+ T-cell responses', 'severe adverse events', 'highest vaccine-induced CD4+ T-cell response rates', 'T-cell and antibody responses', 'BCG revaccination elicited robust, polyfunctional BCG-specific CD4+ T cells', 'safety and immunogenicity', 'safe and well-tolerated', 'H4- or H56-specific']","[{'cui': 'C0026926', 'cui_str': 'Mycobacterium tuberculosis'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C2713304', 'cui_str': 'Revaccination'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0034861', 'cui_str': 'Recombinant protein'}]","[{'cui': 'C0456981', 'cui_str': 'Specific antigen'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C2713304', 'cui_str': 'Revaccination'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",84.0,0.0974093,H4:IC31 and H56:IC31 elicited CD4+ T cells recognizing vaccine-matched antigens and H4- and H56-specific IgG binding antibodies.,"[{'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'The Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'One', 'Initials': 'O', 'LastName': 'Dintwe', 'Affiliation': 'Cape Town HVTN Immunology Laboratory, Cape Town, South Africa.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fiore-Gartland', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Middelkoop', 'Affiliation': 'The Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Hutter', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'April K', 'Initials': 'AK', 'LastName': 'Randhawa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Ruhwald', 'Affiliation': 'Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kromann', 'Affiliation': 'Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Andersen', 'Affiliation': 'Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'DiazGranados', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, United States.'}, {'ForeName': 'Kathryn T', 'Initials': 'KT', 'LastName': 'Rutkowski', 'Affiliation': 'Aeras, Rockville, MD, United States.'}, {'ForeName': 'Dereck', 'Initials': 'D', 'LastName': 'Tait', 'Affiliation': 'Aeras, Cape Town, South Africa.'}, {'ForeName': 'Maurine D', 'Initials': 'MD', 'LastName': 'Miner', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Andersen-Nissen', 'Affiliation': 'Cape Town HVTN Immunology Laboratory, Cape Town, South Africa.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'De Rosa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Seaton', 'Affiliation': 'Duke Human Vaccine Institute, Departments of Surgery, Immunology, and Molecular Genetics and Microbiology, Duke University School of Medicine, Durham, NC, United States.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Duke Human Vaccine Institute, Departments of Surgery, Immunology, and Molecular Genetics and Microbiology, Duke University School of Medicine, Durham, NC, United States.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Ginsberg', 'Affiliation': 'Aeras, Rockville, MD, United States.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100313']
73,32379638,Can Qigong improve non-motor symptoms in people with Parkinson's disease - A pilot randomized controlled trial?,"Non-motor symptoms (NMS) including sleep disorders, anxiety, depression, fatigue, and cognitive decline can significantly impact quality of life in people with PD. Qigong exercise is a mind-body exercise that shows a wide range of benefits in various medical conditions. The purpose of this study was to investigate the effect of Qigong exercise on NMS with a focus on sleep quality. Seventeen participants completed a 12-week intervention of Qigong (n = 8) or sham Qigong (n = 9). Disease severity, anxiety and depression levels, fatigue, cognition, quality of life, and other NMS of the participants were evaluated prior to the intervention and at the end of the 12-week intervention. After the intervention, both Qigong and sham-Qigong group showed significant improvement in sleep quality (p < 0.05) and overall NMS (p < 0.05). No significant difference was found between groups. Qigong exercise has the potential as a rehabilitation method for people with PD, specifically alleviating NMS in PD. However, this finding needs to be carefully considered due to the small sample size and potentially low intervention fidelity of this study.",2020,"Qigong exercise has the potential as a rehabilitation method for people with PD, specifically alleviating NMS in PD.","['Seventeen participants completed a 12-week', ""people with Parkinson's disease"", 'people with PD']","['intervention of Qigong (n\xa0=\xa08) or sham', 'Can Qigong', 'Qigong exercise']","['Disease severity, anxiety and depression levels, fatigue, cognition, quality of life, and other NMS', 'overall NMS', 'sleep quality', 'sleep disorders, anxiety, depression, fatigue, and cognitive decline']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}]",17.0,0.0613723,"Qigong exercise has the potential as a rehabilitation method for people with PD, specifically alleviating NMS in PD.","[{'ForeName': 'Sanghee', 'Initials': 'S', 'LastName': 'Moon', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: smoon@kumc.edu.'}, {'ForeName': 'Caio V M', 'Initials': 'CVM', 'LastName': 'Sarmento', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, USA; Department of Physical Therapy, Department of Physical Therapy, California State University, Fresno, CA, USA. Electronic address: caio@mail.fresnostate.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Steinbacher', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: msteinbacher2@kumc.edu.'}, {'ForeName': 'Irina V', 'Initials': 'IV', 'LastName': 'Smirnova', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: ismrinova@kumc.edu.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Colgrove', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: ycolgrove@kumc.edu.'}, {'ForeName': 'Sue-Min', 'Initials': 'SM', 'LastName': 'Lai', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: slai@kumc.edu.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Lyons', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: klyons@kumc.edu.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: wliu@kumc.edu.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101169']
74,32384727,Benefits of a Three-Day Bamboo Forest Therapy Session on the Physiological Responses of University Students.,"Studies have indicated that natural environments have the potential to improve the relationship between a stressful life and psychological well-being and physical health. Forest therapy has recently received widespread attention as a novel solution for stress recovery and health promotion. Bamboo is an important forest type in many countries, especially in East and Southeast Asia and in African countries. Bamboo is widespread throughout southwestern China. Empirical field research on the physiological effects of bamboo forest therapy is currently lacking. To explore the benefits of bamboo forest therapy on the physiological responses of university students, 120 university volunteers between the ages of 19 and 24 participated in this study (60 males and 60 females) and were randomly divided into four groups of equal size (15 males and 15 females in each). Four sites were selected for the experiment, including two natural bamboo forests (YA and YB), a bamboo forest park (DJY), and an urban environment (CS). During the testing period, all participants were asked to view the landscape for 15 min in the morning and then walk in the testing area for 15 min in the afternoon. Blood pressure (BP), heart rate (HR), and peripheral oxygen saturation (SpO2) were measured as the physiological indexes, and the semantic differential method (SDM) questionnaire was completed for the environmental satisfaction evaluation. The SDM for the subjective environmental evaluation differed significantly among the university students; they obtained a better environmental experience, in terms of sensory perception, atmosphere, climate, place, and space, in the bamboo forest sites. The three-day bamboo forest therapy session improved the physiological well-being of university students. First, the blood pressure and heart rate of the university students decreased, and the SpO2 increased, after the three-day viewing and walking activities of the three-day bamboo forest therapy session. The viewing activities had a more pronounced effect on decreased heart rate in university students. Additionally, three-day bamboo forest therapy had a positive impact on decreased systolic blood pressure and heart rate in the university students, and it was significantly decreased in females, while peripheral oxygen saturation (SpO2) remained relatively low. Finally, compared with the urban site (CS), the bamboo forest sites effectively improved the university students' physiological state of health, decreased their physical pressure, and stabilized their physiological indicators. These findings provide scientific evidence that a three-day bamboo forest therapy session can increase positive physiological responses. The potential for a longer-term effect on human physiological health requires further investigation.",2020,"The SDM for the subjective environmental evaluation differed significantly among the university students; they obtained a better environmental experience, in terms of sensory perception, atmosphere, climate, place, and space, in the bamboo forest sites.","['university students, 120 university volunteers between the ages of 19 and 24 participated in this study (60 males and 60 females) and were randomly divided into four groups of equal size (15 males and 15 females in each', 'Four sites were selected for the experiment, including two natural bamboo forests (YA and YB), a bamboo forest park (DJY), and an urban environment (CS', 'University Students', 'university students']",['bamboo forest therapy'],"['Blood pressure (BP), heart rate (HR), and peripheral oxygen saturation (SpO2', ""university students' physiological state of health, decreased their physical pressure, and stabilized their physiological indicators"", 'semantic differential method (SDM) questionnaire', 'heart rate', 'blood pressure and heart rate of the university students', 'peripheral oxygen saturation (SpO2', 'systolic blood pressure and heart rate', 'positive physiological responses']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C1337281', 'cui_str': 'Bamboo extract'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}]","[{'cui': 'C1337281', 'cui_str': 'Bamboo extract'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0036611', 'cui_str': 'Differential, Semantic'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",120.0,0.0259646,"The SDM for the subjective environmental evaluation differed significantly among the university students; they obtained a better environmental experience, in terms of sensory perception, atmosphere, climate, place, and space, in the bamboo forest sites.","[{'ForeName': 'Chengcheng', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Bingyang', 'Initials': 'B', 'LastName': 'Lyu', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Songyuan', 'Initials': 'S', 'LastName': 'Deng', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Nian', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Qibing', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17093238']
75,32385851,Long-acting pasireotide improves clinical signs and quality of life in Cushing's disease: results from a phase III study.,"PURPOSE


Cushing's disease (CD) is associated with significant clinical burden, increased mortality risk, and impaired health-related quality of life (HRQoL). This analysis explored the effect of long-acting pasireotide on clinical signs of hypercortisolism and HRQoL in a large subset of patients with CD.
METHODS


In this phase III study (clinicaltrials.gov: NCT01374906), 150 adults with CD and a mean urinary free cortisol (mUFC) level between 1.5 and 5.0 times the upper limit of normal (ULN) started long-acting pasireotide 10 or 30 mg every 28 days with dose increases/decreases permitted based on mUFC levels/tolerability (minimum/maximum dose: 5/40 mg). Changes in clinical signs of hypercortisolism and HRQoL were assessed over 12 months of treatment and were stratified by degree of mUFC control for each patient.
RESULTS


Patients with controlled mUFC at month 12 (n = 45) had the greatest improvements from baseline in mean systolic (- 8.4 mmHg [95% CI - 13.9, - 2.9]) and diastolic blood pressure (- 6.0 mmHg [- 10.0, - 2.0]). Mean BMI, weight, and waist circumference improved irrespective of mUFC control. Significant improvements in CushingQoL total score of 5.9-8.3 points were found at month 12 compared with baseline, irrespective of mUFC control; changes were driven by improvements in physical problem score, with smaller improvements in psychosocial score.
CONCLUSIONS


Long-acting pasireotide provided significant improvements in clinical signs and HRQoL over 12 months of treatment, which, in some cases, occurred regardless of mUFC control. Long-acting pasireotide represents an effective treatment option and provides clinical benefit in patients with CD.
CLINICAL TRIAL REGISTRATION NUMBER


NCT01374906.",2020,"Changes in clinical signs of hypercortisolism and HRQoL were assessed over 12 months of treatment and were stratified by degree of mUFC control for each patient.
","['patients with CD', ""Cushing's disease"", '150 adults with CD and a mean urinary free cortisol (mUFC) level between 1.5 and 5.0 times the upper limit of normal (ULN) started long-acting pasireotide 10 or 30']",['Long-acting pasireotide'],"['clinical signs and HRQoL', 'Mean BMI, weight, and waist circumference', 'mean systolic', 'clinical signs and quality of life', 'mortality risk, and impaired health-related quality of life (HRQoL', 'psychosocial score', 'CushingQoL total score', 'diastolic blood pressure', 'mUFC levels/tolerability', 'physical problem score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221406', 'cui_str': 'Pituitary dependent hypercortisolism'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0474662', 'cui_str': 'Cortisol measurement, free, urine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0684336', 'cui_str': 'Impairment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0474662', 'cui_str': 'Cortisol measurement, free, urine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",150.0,0.0585942,"Changes in clinical signs of hypercortisolism and HRQoL were assessed over 12 months of treatment and were stratified by degree of mUFC control for each patient.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lacroix', 'Affiliation': ""Centre hospitalier de l'Université de Montréal, 3840 Saint-Urbain, Montreal, H2W1T8, Canada. andre.lacroix@umontreal.ca.""}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Bronstein', 'Affiliation': 'University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schopohl', 'Affiliation': 'Medizinische Klinik und Poliklinik IV, Ludwig-Maximilians-Universität München, Munich, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Delibasi', 'Affiliation': 'Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Salvatori', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, and Pituitary Center, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology and Metabolism, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Barkan', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Suzaki', 'Affiliation': 'Nagoya Medical Center, National Hospital Organization, Nagoya, Japan.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tauchmanova', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'C-E', 'Initials': 'CE', 'LastName': 'Ortmann', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ravichandran', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Petersenn', 'Affiliation': 'ENDOC Center for Endocrine Tumors, Hamburg, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pivonello', 'Affiliation': 'Università Federico II di Napoli, Naples, Italy.'}]",Journal of endocrinological investigation,['10.1007/s40618-020-01246-0']
76,32391894,Effect of Viewing Disney Movies During Chemotherapy on Self-Reported Quality of Life Among Patients With Gynecologic Cancer: A Randomized Clinical Trial.,"Importance


In addition to treatment efficacy, evaluation of adverse effects and quality of life assessments have become increasingly relevant in oncology.
Objective


To evaluate the association of watching Disney movies during chemotherapy with emotional and social functioning and fatigue status.
Design, Setting, and Participants


This randomized clinical trial was performed from December 2017 to December 2018 at a cancer referral center in Vienna, Austria. A consecutive sample of women with gynecologic cancers was recruited through July 2018. Inclusion criteria included age older than 18 years, written informed consent, and planned 6 cycles of chemotherapy with either carboplatin and paclitaxel or carboplatin and pegylated liposomal doxorubicin. Exclusion criteria were inadequate knowledge of the German language or receipt of other chemotherapy regimens. Data analysis was performed from February 2019 to April 2019.
Intervention


Participants were either shown Disney movies or not during 6 cycles of chemotherapy. Before and after every cycle, they completed standardized questionnaires from the European Organisation for Research and Treatment of Cancer (EORTC).
Main Outcomes and Measures


Primary outcomes were change of quality of life, as defined by the EORTC Core-30 (version 3) questionnaire, and fatigue, as defined by the EORTC Quality of Life Questionnaire Fatigue, during 6 cycles of chemotherapy.
Results


Fifty-six women entered the study, and 50 completed it, including 25 women in the Disney group (mean [SD] age, 59 [12] years) and 25 women in the control group (mean [SD] age, 62 [8] years). In the course of 6 cycles of chemotherapy, patients in the Disney group felt less tense and worried less than patients in the control group according to their responses to the questions about emotional functioning (mean [SD] score, 86.9 [14.3] vs 66.3 [27.2]; maximum test P = .02). Furthermore, watching Disney movies was associated with less encroachment on patients' family life and social activities, as evaluated by the social functioning questions (mean [SD] score, 86.1 [23.0] vs 63.6 [33.6]; maximum test P = .01). Moreover, this intervention led to fewer fatigue symptoms (mean [SD] score, 85.5 [13.6] vs 66.4 [22.5]; maximum test P = .01). Perceived global health status was not associated with watching Disney movies (mean [SD] score, 75.9 [17.6] vs 61.0 [25.1]; maximum test P = .16).
Conclusions and Relevance


These findings suggest that watching Disney movies during chemotherapy may be associated with improvements in emotional functioning, social functioning, and fatigue status in patients with gynecologic cancers.
Trial Registration


ClinicalTrials.gov Identifier: NCT03863912.",2020,"Furthermore, watching Disney movies was associated with less encroachment on patients' family life and social activities, as evaluated by the social functioning questions (mean [SD] score, 86.1 [23.0] vs 63.6 [33.6]; maximum test P = .01).","['Inclusion criteria included age older than 18 years, written informed consent, and planned 6 cycles of chemotherapy with either', 'December 2017 to December 2018 at a cancer referral center in Vienna, Austria', 'women with gynecologic cancers was recruited through July 2018', 'Patients With Gynecologic Cancer', 'patients with gynecologic cancers', 'Fifty-six women entered the study, and 50 completed it, including 25 women in the Disney group (mean [SD] age, 59 [12] years) and 25 women in the control group (mean [SD] age, 62 [8] years']","['Viewing Disney Movies', 'carboplatin and paclitaxel or carboplatin and pegylated liposomal doxorubicin']","['Perceived global health status', 'Quality of Life', 'change of quality of life, as defined by the EORTC Core-30 (version 3) questionnaire, and fatigue, as defined by the EORTC Quality of Life Questionnaire Fatigue', 'emotional functioning, social functioning, and fatigue status', 'fatigue symptoms', ""patients' family life and social activities"", 'social functioning questions']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015608', 'cui_str': 'Family Relationship'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.15327,"Furthermore, watching Disney movies was associated with less encroachment on patients' family life and social activities, as evaluated by the social functioning questions (mean [SD] score, 86.1 [23.0] vs 63.6 [33.6]; maximum test P = .01).","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pils', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Ott', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reinthaller', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Enikoe', 'Initials': 'E', 'LastName': 'Steiner', 'Affiliation': 'Department of Obstetrics and Gynecology, General Hospital of Vienna, Vienna, Austria.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Springer', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Ristl', 'Affiliation': 'Section for Medical Statistics, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Vienna, Austria.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.4568']
77,32320894,Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracic Surgery Lobectomy.,"BACKGROUND


A narrow-profile powered vascular stapler (PVS) was developed to provide superior access and precise staple placement in thoracic procedures. The objective of this study was to determine if the PVS would yield an equivalent rate of hemostatic interventions compared with standard of care (SOC) staplers in video-assisted thoracoscopic surgery lobectomy.
MATERIALS AND METHODS


A randomized, controlled, multicenter study was conducted comparing PVS with SOC staplers in lobectomies performed for non-small cell lung cancer. The primary performance endpoint was the incidence of intraoperative hemostatic interventions, and the primary safety endpoint was the frequency of postoperative bleeding-related interventions.
RESULTS


A total of 98 subjects participated in the SOC group and 103 in the PVS group. Rates of intraoperative hemostatic interventions were 5.3% and 8.3% for the SOC and PVS groups, respectively. These rates were not statistically different (P = 0.137), although the upper bound of the 95% confidence interval for the difference in intervention rates between PVC and SOC exceeded a predefined 3% criterion for equivalence. Simple compressions were performed more frequently in the PVS subjects, which accounted for the higher intervention rate in this group. Postoperative interventions for bleeding were required in one SOC subject (1.0%) and one subject from the PVS group (0.9%). Procedure-related adverse events occurred in 21 (21.9%) SOC subjects and 23 (21.9%) PVS subjects, with no adverse events related to use of the study devices.
CONCLUSIONS


The PVS exhibited similar overall safety and effectiveness to SOC staplers in video-assisted thoracoscopic surgery lobectomy.",2020,The PVS exhibited similar overall safety and effectiveness to SOC staplers in video-assisted thoracoscopic surgery lobectomy.,"['98 subjects participated in the SOC group and 103 in the PVS group', 'non-small cell lung cancer']","['Powered Vascular Stapler in Video-Assisted Thoracic Surgery Lobectomy', 'standard of care (SOC) staplers in video-assisted thoracoscopic surgery lobectomy', 'SOC staplers', 'vascular stapler (PVS', 'PVS with SOC staplers']","['frequency of postoperative bleeding-related interventions', 'Procedure-related adverse events', 'incidence of intraoperative hemostatic interventions', 'Rates of intraoperative hemostatic interventions']","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C4520228', 'cui_str': 'Thoracoscopic surgical lobectomy using video-assisted guidance'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}]",98.0,0.124483,The PVS exhibited similar overall safety and effectiveness to SOC staplers in video-assisted thoracoscopic surgery lobectomy.,"[{'ForeName': 'Laureano', 'Initials': 'L', 'LastName': 'Molins', 'Affiliation': 'Department of Thoracic Surgery, Barcelona University, Barcelona, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lanuti', 'Affiliation': 'Division of Thoracic Surgery, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Force', 'Affiliation': 'Department of Surgery, The Emory Clinic, Atlanta, Georgia, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Woolley', 'Affiliation': 'Consultant Thoracic Surgeon, Liverpool Heart & Chest Hospital, Liverpool, UK.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Krantz', 'Affiliation': 'Division of Thoracic Surgery, Northshore University Health System, Evanston, Illinois, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Creedon', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Schwiers', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Singleton', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA. Electronic address: dsingl12@its.jnj.com.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Waggoner', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Fryrear', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Licht', 'Affiliation': 'Department of Cardiothoracic Surgery, Odense University Hospital, Odense, Denmark.'}]",The Journal of surgical research,['10.1016/j.jss.2020.03.023']
78,32334703,"Clopidogrel versus ticagrelor or prasugrel in patients aged 70 years or older with non-ST-elevation acute coronary syndrome (POPular AGE): the randomised, open-label, non-inferiority trial.","BACKGROUND


Current guidelines recommend potent platelet inhibition with ticagrelor or prasugrel in patients after an acute coronary syndrome. However, data about optimal platelet inhibition in older patients are scarce. We aimed to investigate the safety and efficacy of clopidogrel compared with ticagrelor or prasugrel in older patients with non-ST-elevation acute coronary syndrome (NSTE-ACS).
METHODS


We did the open-label, randomised controlled POPular AGE trial in 12 sites (ten hospitals and two university hospitals) in the Netherlands. Patients aged 70 years or older with NSTE-ACS were enrolled and randomly assigned in a 1:1 ratio using an internet-based randomisation procedure with block sizes of six to receive a loading dose of clopidogrel 300 mg or 600 mg, or ticagrelor 180 mg or prasugrel 60 mg, and then a maintenance dose for the duration of 12 months (clopidogrel 75 mg once daily, ticagrelor 90 mg twice daily, or prasugrel 10 mg once daily) on top of standard care. Patient and treating physicians were aware of the allocated treatment strategy, but the outcome assessors were masked to treatment allocation. Primary bleeding outcome consisted of PLATelet inhibition and patient Outcomes (PLATO; major or minor bleeding [superiority hypothesis]). Co-primary net clinical benefit outcome consisted of all-cause death, myocardial infarction, stroke, PLATO major and minor bleeding (non-inferiority hypothesis, margin of 2%). Follow-up duration was 12 months. Analyses were done on intention-to-treat basis. This trial is registered with the Netherlands Trial Register (NL3804), ClinicalTrials.gov (NCT02317198), and EudraCT (2013-001403-37).
FINDINGS


Between June 10, 2013, and Oct 17, 2018, 1002 patients were randomly assigned to clopidogrel (n=500) or ticagrelor or prasugrel (n=502). Because 475 (95%) patients received ticagrelor in the ticagrelor or prasugrel group, we will refer to this group as the ticagrelor group. Premature discontinuation of the study drug occurred in 238 (47%) of 502 ticagrelor group patients randomly assigned to ticagrelor, and in 112 (22%) of 500 patients randomly assigned to clopidogrel. Primary bleeding outcome was significantly lower in the clopidogrel group (88 [18%] of 500 patients) than in the ticagrelor group (118 [24%] of 502; hazard ratio 0·71, 95% CI 0·54 to 0·94; p=0·02 for superiority). Co-primary net clinical benefit outcome was non-inferior for the use of clopidogrel (139 [28%]) versus ticagrelor (161 [32%]; absolute risk difference -4%, 95% CI -10·0 to 1·4; p=0·03 for non-inferiority). The most important reasons for discontinuation were occurrence of bleeding (n=38), dyspnoea (n=40), and the need for treatment with oral anticoagulation (n=35).
INTERPRETATION


In patients aged 70 years or older presenting with NSTE-ACS, clopidogrel is a favourable alternative to ticagrelor, because it leads to fewer bleeding events without an increase in the combined endpoint of all-cause death, myocardial infarction, stroke, and bleeding. Clopidogrel could be an alternative P2Y12 inhibitor especially for elderly patients with a higher bleeding risk.
FUNDING


ZonMw.",2020,"Primary bleeding outcome was significantly lower in the clopidogrel group (88 [18%] of 500 patients) than in the ticagrelor group (118 [24%] of 502; hazard ratio 0·71, 95% CI 0·54 to 0·94; p=0·02 for superiority).","['12 sites (ten hospitals and two university hospitals) in the Netherlands', 'Between June 10, 2013, and Oct 17, 2018, 1002 patients', 'patients after an acute coronary syndrome', 'patients aged 70 years or older presenting with NSTE-ACS', 'patients aged 70 years or older with non-ST-elevation acute coronary syndrome (POPular AGE', 'older patients', 'Patients aged 70 years or older with NSTE-ACS', 'older patients with non-ST-elevation acute coronary syndrome (NSTE-ACS', 'elderly patients with a higher bleeding risk']","['clopidogrel', 'ticagrelor', 'Clopidogrel versus ticagrelor or prasugrel', 'clopidogrel 75 mg once daily, ticagrelor 90 mg twice daily, or prasugrel 10 mg once daily) on top of standard care', 'ticagrelor or prasugrel', 'Clopidogrel', 'clopidogrel 300 mg or 600 mg, or ticagrelor 180 mg or prasugrel']","['PLATelet inhibition and patient Outcomes (PLATO; major or minor bleeding [superiority hypothesis', 'death, myocardial infarction, stroke, PLATO major and minor bleeding', 'safety and efficacy', 'Primary bleeding outcome']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C1124675', 'cui_str': 'clopidogrel 75 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C3163568', 'cui_str': 'Ticagrelor 90 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C2710118', 'cui_str': 'prasugrel 10 MG'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1968319', 'cui_str': 'clopidogrel 300 MG'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0043566', 'cui_str': '(1,2-diamino-4-nitrobenzene)dichloroplatinum(II)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",1002.0,0.222636,"Primary bleeding outcome was significantly lower in the clopidogrel group (88 [18%] of 500 patients) than in the ticagrelor group (118 [24%] of 502; hazard ratio 0·71, 95% CI 0·54 to 0·94; p=0·02 for superiority).","[{'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Gimbel', 'Affiliation': 'Department of Cardiology, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Qaderdan', 'Affiliation': 'Department of Cardiology, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Willemsen', 'Affiliation': 'Department of Cardiology, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Hermanides', 'Affiliation': 'Department of Cardiology, Isala Hospitals, Zwolle, Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bergmeijer', 'Affiliation': 'Department of Cardiology, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'de Vrey', 'Affiliation': 'Department of Cardiology, Meander Medical Centre, Amersfoort, Netherlands.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Heestermans', 'Affiliation': 'Department of Cardiology, Noord-west Hospital group, Alkmaar, Netherlands.'}, {'ForeName': 'Melvyn', 'Initials': 'M', 'LastName': 'Tjon Joe Gin', 'Affiliation': 'Department of Cardiology, Rijnstate, Arnhem, Netherlands.'}, {'ForeName': 'Reinier', 'Initials': 'R', 'LastName': 'Waalewijn', 'Affiliation': 'Department of Cardiology, Gelre Hospitals, Apeldoorn, Netherlands.'}, {'ForeName': 'Sjoerd', 'Initials': 'S', 'LastName': 'Hofma', 'Affiliation': 'Department of Cardiology, Medical Centre Leeuwarden, Leeuwarden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'den Hartog', 'Affiliation': 'Department of Cardiology, Gelderse Vallei Hospital, Ede, Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leids University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Medisch Spectrum Twente, Enschede, Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Voskuil', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kelder', 'Affiliation': 'Department of Cardiology, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Deneer', 'Affiliation': 'Department of Cardiology, St Antonius Hospital, Nieuwegein, Netherlands; Department of Clinical Pharmacy, Division of Laboratories, Pharmacy, and Biomedical Genetics University Medical Center Utrecht and Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Jurriën', 'Initials': 'J', 'LastName': 'Ten Berg', 'Affiliation': 'Department of Cardiology, St Antonius Hospital, Nieuwegein, Netherlands. Electronic address: j.ten.berg@antoniusziekenhuis.nl.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30325-1']
79,32278278,Neural correlates of emotional reactivity and regulation associated with treatment response in a randomized clinical trial for posttraumatic stress disorder.,"Posttraumatic Stress Disorder (PTSD) is a debilitating condition often associated with difficulty in emotion regulation, including reappraising negative emotions. This study assessed neural mechanisms associated with emotion regulation in veterans prior to and following treatment for PTSD. Participants with PTSD and combat exposed controls (CC) completed diagnostic evaluation and underwent fMRI scanning while completing Emotion Regulation Task (ERT) and Emotional Faces Assessment Task (EFAT). Participants with PTSD were randomly assigned to Prolonged Exposure plus placebo (PE+PLB), Sertraline plus enhanced medication management (SERT+EMM), or PE plus SERT (PE+SERT) and repeated diagnostic evaluation and MRI scanning following treatment. The amygdala, dmPFC, and dlPFC were examined as regions of interest. On ERT, veterans with PTSD showed significantly less dmPFC activation than CCs during reappraisal vs emotional maintenance. Within the PTSD group, results demonstrated a significant association between less activation in the dmPFC during emotion reappraisal vs maintenance trials before treatment and greater reductions in symptoms from pre- to post-treatment. During the EFAT, there were no group differences between participants with PTSD and CCs in brain activation, and no relationships between brain function and PTSD symptoms. These findings suggest that less emotional reactivity might potentially reflect less need for recruitment of prefrontal regions when reappraising negative emotion, and is an individual factor associated with better treatment outcome.",2020,"Within the PTSD group, results demonstrated a significant association between less activation in the dmPFC during emotion reappraisal vs maintenance trials before treatment and greater reductions in symptoms from pre- to post-treatment.","['posttraumatic stress disorder', 'Participants with PTSD and combat exposed controls (CC) completed diagnostic evaluation and underwent', 'Participants with PTSD', 'veterans prior to and following treatment for PTSD', 'Posttraumatic Stress Disorder (PTSD']","['fMRI scanning while completing Emotion Regulation Task (ERT) and Emotional Faces Assessment Task (EFAT', 'Prolonged Exposure plus placebo (PE+PLB), Sertraline plus enhanced medication management (SERT+EMM), or PE plus SERT (PE+SERT) and repeated diagnostic evaluation and MRI scanning']","['dmPFC activation', 'amygdala, dmPFC, and dlPFC']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]",,0.020995,"Within the PTSD group, results demonstrated a significant association between less activation in the dmPFC during emotion reappraisal vs maintenance trials before treatment and greater reductions in symptoms from pre- to post-treatment.","[{'ForeName': 'Sonalee A', 'Initials': 'SA', 'LastName': 'Joshi', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI 48109, United States; University of Michigan, Department of Psychology, 530 Church St, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Duval', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Jony', 'Initials': 'J', 'LastName': 'Sheynin', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI 48109, United States; Texas A&M University Health Science Center, Department of Psychiatry, 8441 Riverside Parkway, Bryan, TX 77807, United States.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'King', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry and Behavioral Health, The Ohio State University 1670 Upham Drive, Columbus, OH 43210, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Martis', 'Affiliation': 'University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI 48109, United States; VA San Diego Healthcare System, 3350 Villa La Jolla Drive, San Diego, CA 92161, United States; University of California, San Diego, School of Medicine, 9500 Gilman Drive, La Jolla, CA 92037, United States.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Porter', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI 48105, United States; Texas A&M University Health Science Center, Department of Psychiatry, 8441 Riverside Parkway, Bryan, TX 77807, United States. Electronic address: liberzon@tamu.edu.'}, {'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Atlanta VA Medical Center, 1670 Clairmont Road, Decatur, GA 30033, United States; Emory University School of Medicine, 12 Executive Park, 3rd Floor, Atlanta, GA 30029, United States.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111062']
80,32223112,Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer.,"BACKGROUND


Recent guidelines recommend consideration of the use of oral edoxaban or rivaroxaban for the treatment of venous thromboembolism in patients with cancer. However, the benefit of these oral agents is limited by the increased risk of bleeding associated with their use.
METHODS


This was a multinational, randomized, investigator-initiated, open-label, noninferiority trial with blinded central outcome adjudication. We randomly assigned consecutive patients with cancer who had symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive oral apixaban (at a dose of 10 mg twice daily for the first 7 days, followed by 5 mg twice daily) or subcutaneous dalteparin (at a dose of 200 IU per kilogram of body weight once daily for the first month, followed by 150 IU per kilogram once daily). The treatments were administered for 6 months. The primary outcome was objectively confirmed recurrent venous thromboembolism during the trial period. The principal safety outcome was major bleeding.
RESULTS


Recurrent venous thromboembolism occurred in 32 of 576 patients (5.6%) in the apixaban group and in 46 of 579 patients (7.9%) in the dalteparin group (hazard ratio, 0.63; 95% confidence interval [CI], 0.37 to 1.07; P<0.001 for noninferiority). Major bleeding occurred in 22 patients (3.8%) in the apixaban group and in 23 patients (4.0%) in the dalteparin group (hazard ratio, 0.82; 95% CI, 0.40 to 1.69; P = 0.60).
CONCLUSIONS


Oral apixaban was noninferior to subcutaneous dalteparin for the treatment of cancer-associated venous thromboembolism without an increased risk of major bleeding. (Funded by the Bristol-Myers Squibb-Pfizer Alliance; Caravaggio ClinicalTrials.gov number, NCT03045406.).",2020,"Major bleeding occurred in 22 patients (3.8%) in the apixaban group and in 23 patients (4.0%) in the dalteparin group (hazard ratio, 0.82; 95% CI, 0.40 to 1.69; P = 0.60).
","['patients with cancer', 'consecutive patients with cancer who had symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive', 'Venous Thromboembolism Associated with Cancer']","['edoxaban or rivaroxaban', 'apixaban', 'Apixaban', 'subcutaneous dalteparin', 'dalteparin', 'oral apixaban']","['Major bleeding', 'recurrent venous thromboembolism', 'Recurrent venous thromboembolism', 'major bleeding', 'risk of major bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0444507', 'cui_str': 'Incidental (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0206461', 'cui_str': 'Dalteparin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.301802,"Major bleeding occurred in 22 patients (3.8%) in the apixaban group and in 23 patients (4.0%) in the dalteparin group (hazard ratio, 0.82; 95% CI, 0.40 to 1.69; P = 0.60).
","[{'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Agnelli', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Becattini', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Meyer', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Muñoz', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Menno V', 'Initials': 'MV', 'LastName': 'Huisman', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Connors', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Bauersachs', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Brenner', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Torbicki', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Maria R', 'Initials': 'MR', 'LastName': 'Sueiro', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Gualberto', 'Initials': 'G', 'LastName': 'Gussoni', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Campanini', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fontanella', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Vescovo', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Verso', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915103']
81,32333793,"Protective effects of dietary fish-oil supplementation on skin inflammatory and oxidative stress biomarkers induced by fine particulate air pollution: a pilot randomized, double-blind, placebo-controlled trial.","BACKGROUND


Exposure to fine particulate matter (with an aerodynamic diameter ≤ 2·5 μm, PM 2·5  ) air pollution has been associated with skin-related diseases or disorders.
OBJECTIVES


To evaluate the potential skin-protective effects of fish-oil supplementation against PM 2·5  exposure.
MATERIALS AND METHODS


This is an exploratory analysis based on a pilot randomized, double-blind, placebo-controlled trial among 65 healthy young adults between September 2017 and January 2018 in Shanghai, China. We randomly assigned participants to take either fish oil or placebo 2·5 g daily for four consecutive months. Four rounds of skin D-Squame ®  tape samples were collected in the last 2 months, and five secondary biomarkers of skin inflammation and oxidative stress were measured. Fixed-site PM 2·5  concentrations on campus were measured in real time. We used linear mixed-effect models to analyse the associations between short-term PM 2·5  exposure and biomarkers in each group.
RESULTS


The 24-h average PM 2·5  concentration was 34·68 ± 15·83 μg m -3  . There were generally weaker associations between PM 2·5  and biomarkers in the fish-oil group than in the placebo group, but the associations and the between-group differences varied by biomarkers and lag periods. Compared with the placebo group, for a 10-μg m -3  increase in PM 2·5  concentration, the increments of interleukin-1α and carbonyl protein in the fish-oil group were 41·55% smaller [95% confidence interval (CI) 4·61-78·48%] at lag 0-48 h and 22·01% smaller (95% CI 11·25-32·77%) at lag 0-24 h, respectively. No significant between-group differences were observed for other biomarkers.
CONCLUSIONS


This study suggested that dietary fish-oil supplementation may improve biomarkers of skin inflammation and oxidative-stress response to short-term PM 2·5  exposure.",2020,"There were generally weaker associations between PM 2.5  and biomarkers in the fish-oil group than in the placebo group, but the associations and the between-group differences varied by biomarkers and lag periods.","['65 healthy young adults between September 2017 and January 2018 in Shanghai, China', 'fine particulate air pollution']","['dietary fish-oil supplementation', 'fish-oil supplementation', 'placebo', 'fish oil or placebo']","['skin inflammation and oxidative stress', 'interleukin-1α and carbonyl protein', 'skin inflammation and oxidative-stress response', 'skin inflammatory and oxidative stress biomarkers']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0457784', 'cui_str': 'Particulate'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",65.0,0.612931,"There were generally weaker associations between PM 2.5  and biomarkers in the fish-oil group than in the placebo group, but the associations and the between-group differences varied by biomarkers and lag periods.","[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Lin', 'Affiliation': 'School of Public Health, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Niu', 'Affiliation': 'School of Public Health, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'School of Public Health, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'School of Public Health, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Shanghai Typhoon Institute/CMA, Shanghai Key Laboratory of Meteorology and Health, Shanghai, 200030, China.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mi', 'Affiliation': 'Unilever Research and Development Center, Shanghai, 200335, China.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Huang', 'Affiliation': 'Unilever Research and Development Center, Shanghai, 200335, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Reproduction Regulation of National Population and Family Planning Commission, Shanghai Institute of Planned Parenthood Research, Institute of Reproduction and Development, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Department of Toxicology, School of Public Health, Anhui Medical University, Hefei, 230032, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'School of Public Health, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kan', 'Affiliation': 'School of Public Health, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai, 200032, China.'}]",The British journal of dermatology,['10.1111/bjd.19156']
82,31613390,Fluoxetine for adults who are overweight or obese.,"BACKGROUND


Fluoxetine is a serotonin reuptake inhibitor indicated for major depression. It is also thought to affect weight control: this seems to happen through appetite changes resulting in decreased food intake and normalisation of unusual eating behaviours. However, the benefit-risk ratio of this off-label medication is unclear.
OBJECTIVES


To assess the effects of fluoxetine for overweight or obese adults.
SEARCH METHODS


We searched the Cochrane Library, MEDLINE, Embase, LILACS, the ICTRP Search Portal and ClinicalTrials.gov and World Health Organization (WHO) ICTRP Search Portal. The last date of the search was December 2018 for all databases, to which we applied no language restrictions .
SELECTION CRITERIA


We included randomised controlled trials (RCTs) comparing the administration of fluoxetine versus placebo, other anti-obesity agents, non-pharmacological therapy or no treatment in overweight or obese adults without depression, mental illness or abnormal eating patterns.
DATA COLLECTION AND ANALYSIS


Two review authors independently screened abstracts and titles for relevance. Screening for inclusion, data extraction and risk of bias assessment was performed by one author and checked by the second. We assessed trials for the overall certainty of the evidence using the GRADE instrument. For additional information we contacted trial authors by email. We performed random-effects meta-analyses and calculated the risk ratio (RR) with 95% confidence intervals (95% CI) for dichotomous outcomes and the mean difference (MD) with 95% CI for continuous outcomes.
MAIN RESULTS


We identified 1036 records, scrutinized 52 full-text articles and included 19 completed RCTs (one trial is awaiting assessment). A total of 2216 participants entered the trials, 1280 participants were randomly assigned to fluoxetine (60 mg/d, 40 mg/d, 20 mg/d and 10 mg/d) and 936 participants were randomly assigned to various comparison groups (placebo; the anti-obesity agents diethylpropion, fenproporex, mazindol, sibutramine, metformin, fenfluramine, dexfenfluramine, fluvoxamine, 5-hydroxy-tryptophan; no treatment; and omega-3 gel). Within the 19 RCTs there were 56 trial arms. Fifteen trials were parallel RCTs and four were cross-over RCTs. The participants in the included trials were followed up for periods between three weeks and one year. The certainty of the evidence was low or very low: the majority of trials had a high risk of bias in one or more of the risk of bias domains.For our main comparison group - fluoxetine versus placebo - and across all fluoxetine dosages and durations of treatment, the MD was -2.7 kg (95% CI -4 to -1.4; P < 0.001; 10 trials, 956 participants; low-certainty evidence). The 95% prediction interval ranged between -7.1 kg and 1.7 kg. The MD in body mass index (BMI) reduction across all fluoxetine dosages compared with placebo was -1.1 kg/m² (95% CI -3.7 to 1.4; 3 trials, 97 participants; very low certainty evidence). Only nine placebo-controlled trials reported adverse events. A total of 399 out of 627 participants (63.6%) receiving fluoxetine compared with 352 out of 626 participants (56.2%) receiving placebo experienced an adverse event. Random-effects meta-analysis showed an increase in the risk of having at least one adverse event of any type in the fluoxetine groups compared with placebo (RR 1.18, 95% CI 0.99 to 1.42; P = 0.07; 9 trials, 1253 participants; low-certainty evidence). The 95% prediction interval ranged between 0.74 and 1.88. Following fluoxetine treatment the adverse events of dizziness, drowsiness, fatigue, insomnia and nausea were observed approximately twice as often compared to placebo. A total of 15 out of 197 participants (7.6%) receiving fluoxetine compared with 12 out of 196 participants (6.1%) receiving placebo experienced depression. The RR across all fluoxetine doses compared with placebo was 1.20 (95% CI 0.57 to 2.52; P = 0.62; 3 trials, 393 participants; very low certainty evidence). All-cause mortality, health-related quality of life and socioeconomic effects were not reported.The comparisons of fluoxetine with other anti-obesity agents (3 trials, 234 participants), omega-3 gel (1 trial, 48 participants) and no treatment (1 trial, 60 participants) showed inconclusive results (very low certainty evidence).
AUTHORS' CONCLUSIONS


Low-certainty evidence suggests that off-label fluoxetine may decrease weight compared with placebo. However, low-certainty evidence suggests an increase in the risk for dizziness, drowsiness, fatigue, insomnia and nausea following fluoxetine treatment.",2019,"Following fluoxetine treatment the adverse events of dizziness, drowsiness, fatigue, insomnia and nausea were observed approximately twice as often compared to placebo.","['adults who are overweight or obese', 'overweight or obese adults without depression, mental illness or abnormal eating patterns', '936 participants', '2216 participants entered the trials, 1280 participants', 'overweight or obese adults', 'A total of 399 out of 627 participants (63.6%) receiving', '1036 records, scrutinized 52 full-text articles and included 19 completed RCTs (one trial is awaiting assessment', 'A total of 15 out of 197 participants (7.6%) receiving']","['fluoxetine with other anti-obesity agents', 'fluoxetine versus placebo, other anti-obesity agents, non-pharmacological therapy', 'omega-3 gel', 'placebo', 'fluoxetine', 'various comparison groups (placebo; the anti-obesity agents diethylpropion, fenproporex, mazindol, sibutramine, metformin, fenfluramine, dexfenfluramine, fluvoxamine, 5-hydroxy-tryptophan; no treatment; and omega-3 gel', 'Fluoxetine']","['adverse events of dizziness, drowsiness, fatigue, insomnia and nausea', 'adverse events', 'All-cause mortality, health-related quality of life and socioeconomic effects', 'adverse event', 'MD in body mass index (BMI) reduction', 'risk of having at least one adverse event', 'risk for dizziness, drowsiness, fatigue, insomnia and nausea']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0376607', 'cui_str': 'Antiobesity Agents'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0012201', 'cui_str': 'amfepramone'}, {'cui': 'C0060194', 'cui_str': 'fenproporex'}, {'cui': 'C0024977', 'cui_str': 'Mazindol'}, {'cui': 'C0074493', 'cui_str': 'sibutramine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0015827', 'cui_str': 'Fenfluramine'}, {'cui': 'C0011786', 'cui_str': 'Dexfenfluramine'}, {'cui': 'C0085228', 'cui_str': 'Fluvoxamine'}, {'cui': 'C0000578', 'cui_str': '5-Hydroxytryptophan'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",52.0,0.39632,"Following fluoxetine treatment the adverse events of dizziness, drowsiness, fatigue, insomnia and nausea were observed approximately twice as often compared to placebo.","[{'ForeName': 'Aurora E', 'Initials': 'AE', 'LastName': 'Serralde-Zúñiga', 'Affiliation': 'Clinical Nutrition, Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Sección XVI, Tlalpan, Mexico City, Distrito Federal, Mexico, 14000.'}, {'ForeName': 'Alejandro G', 'Initials': 'AG', 'LastName': 'Gonzalez Garay', 'Affiliation': ''}, {'ForeName': 'Yanelli', 'Initials': 'Y', 'LastName': 'Rodríguez-Carmona', 'Affiliation': ''}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Melendez', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD011688.pub2']
83,31586170,Comment on: A trial of a mechanical device for the treatment of blepharospasm.,,2020,,[],['mechanical device'],[],[],"[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",[],,0.0269564,,"[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Go', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Anderson', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Kini', 'Affiliation': 'Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, 6550 Fannin St, Houston, TX, 77030, USA.'}, {'ForeName': 'Bayan', 'Initials': 'B', 'LastName': 'Al Othman', 'Affiliation': 'Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, 6550 Fannin St, Houston, TX, 77030, USA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Lee', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA. aglee@houstonmethodist.org.'}]","Eye (London, England)",['10.1038/s41433-019-0621-x']
84,31928120,Early stabilization of the uncemented Symax hip stem in a 2-year RSA study.,"Background and purpose - The uncemented Symax hip stem has shown early proximal ingrowth as result of the BONIT-hydroxyapatite (HA) coating and the distal DOTIZE surface treatment. We evaluated 2-year postoperative radiostereometric analysis (RSA) migration of the Symax hip stem in THA patients. We also investigated the correlation between migration at 4 weeks and clinical outcomes after 2 years.Patients and methods - Patients in a 2-year clinical follow-up single-centre RSA randomized controlled trial were randomized to 2 different cup designs. All 45 patients received a Symax hip stem. RSA migration patterns of the Symax hip stem is presented here as a single cohort. RSA examinations were performed postoperatively, but before weight-bearing, and subsequently after 1, 3, 6, 12, and 24 months. Clinical outcomes and radiographic evaluations were assessed 3, 6, 12, and 24 months postoperatively.Results - During the first 4 weeks, the Symax hip stem subsided, rotated into retroversion, and translated posteriorly, after which the migration ceased and the prosthesis stabilized. All clinical outcomes improved from preoperatively to 2 years. There was no clinically or statistically significant correlation between subsidence and retroversion at 4 weeks and clinical outcomes after 2 years.Interpretation - RSA evaluation of the uncemented Symax hip stem confirms that the design principles and coating properties lead to early stabilization of the stem, as early as 4 weeks postoperatively. There was no correlation between subsidence and retroversion at 4 weeks and clinical outcomes after 2 years. Based on the predictive potential of the RSA technique, we anticipate excellent long-term survival of this hip stem.",2020,There was no clinically or statistically significant correlation between subsidence and retroversion at 4 weeks and clinical outcomes after 2 years.,['THA patients'],['Symax hip stem'],['2-year postoperative radiostereometric analysis (RSA) migration'],"[{'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1602476', 'cui_str': 'Symax'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0162731', 'cui_str': 'STEM'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3178874', 'cui_str': 'Radiostereometry'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}]",,0.0520229,There was no clinically or statistically significant correlation between subsidence and retroversion at 4 weeks and clinical outcomes after 2 years.,"[{'ForeName': 'Dennis S M G', 'Initials': 'DSMG', 'LastName': 'Kruijntjens', 'Affiliation': 'Department of Orthopaedic Surgery, Research School Caphri, Maastricht University Medical Centre, Maastricht.'}, {'ForeName': 'Lennard', 'Initials': 'L', 'LastName': 'Koster', 'Affiliation': 'Department of Orthopaedic Surgery, RSAcore, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Kaptein', 'Affiliation': 'Department of Orthopaedic Surgery, RSAcore, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Liesbeth M C', 'Initials': 'LMC', 'LastName': 'Jutten', 'Affiliation': 'Department of Orthopaedic Surgery, Research School Caphri, Maastricht University Medical Centre, Maastricht.'}, {'ForeName': 'Jacobus J', 'Initials': 'JJ', 'LastName': 'Arts', 'Affiliation': 'Department of Orthopaedic Surgery, Research School Caphri, Maastricht University Medical Centre, Maastricht.'}, {'ForeName': 'René H M', 'Initials': 'RHM', 'LastName': 'Ten Broeke', 'Affiliation': 'Department of Orthopaedic Surgery, Research School Caphri, Maastricht University Medical Centre, Maastricht.'}]",Acta orthopaedica,['10.1080/17453674.2019.1709956']
85,31615996,Low Dose Carbon Monoxide Exposure in Idiopathic Pulmonary Fibrosis Produces a CO Signature Comprised of Oxidative Phosphorylation Genes.,"Compelling preclinical studies indicate that low-dose carbon monoxide (CO) abrogates experimental lung fibrosis. We recently reported the results of a multicenter, double-blinded, clinical trial of inhaled CO in patients with idiopathic pulmonary fibrosis (IPF). Identifying no significantly changes in metalloproteinase-7 (MMP7) serum concentration, or secondary endpoints of physiologic measurements, hospitalization, death, or patient-reported outcomes. In the present study, we evaluated the effect of low dose CO exposure (100-200 ppm) for 12 weeks on genome-wide gene expression in peripheral blood mononuclear cells (PBMC) derived from these IPF study subjects. We conducted transcriptome profiling on 38 IPF subjects with time points available at 0, 12, and 24 weeks. Total RNA isolated from PBMCs was hybridized onto the Affymetrix Human Gene 2.0 ST Array. We identified 621 genes significantly upregulated in the 24-week CO exposed group compared with the 12-week. Pathway analysis demonstrated association with Oxidative Phosphorylation (adjusted P < 0.05). We identified a clear CO signature dominated with 23 oxidative phosphorylation-related genes (FDR <10%). We confirmed the expression of nine selected gene products using Nanostring's nCounter analysis system. These findings suggest this signature may serve as a potential genomic biomarker for CO exposure and for potential titration of dosage to allow precision testing of therapies in future low dose CO therapeutic studies in IPF.",2019,Pathway analysis demonstrated association with Oxidative Phosphorylation (adjusted P < 0.05).,"['patients with idiopathic pulmonary fibrosis (IPF', '38 IPF subjects with time points available at 0, 12, and 24 weeks']","['low-dose carbon monoxide (CO', 'inhaled CO', 'Low Dose Carbon Monoxide Exposure']","['peripheral blood mononuclear cells (PBMC', 'metalloproteinase-7 (MMP7) serum concentration, or secondary endpoints of physiologic measurements, hospitalization, death, or patient-reported outcomes', 'Oxidative Phosphorylation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C0332311', 'cui_str': 'With time (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0238889', 'cui_str': 'Exposure to carbon monoxide (event)'}]","[{'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0025543', 'cui_str': 'Metalloproteases'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0199213', 'cui_str': 'Physiologic measurement'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0030013', 'cui_str': 'Oxidative Phosphorylation'}]",,0.0357632,Pathway analysis demonstrated association with Oxidative Phosphorylation (adjusted P < 0.05).,"[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Casanova', 'Affiliation': 'Department of Medicine, University of Arizona Health Sciences, Tucson, AZ, USA.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Physiology and Cell Biology, University of Nevada School of Medicine, Reno, NV, USA.'}, {'ForeName': 'Manuel L', 'Initials': 'ML', 'LastName': 'Gonzalez-Garay', 'Affiliation': 'Department of Medicine, University of Arizona Health Sciences, Tucson, AZ, USA.'}, {'ForeName': 'Ivan O', 'Initials': 'IO', 'LastName': 'Rosas', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Hilary J', 'Initials': 'HJ', 'LastName': 'Goldberg', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Stefan W', 'Initials': 'SW', 'LastName': 'Ryter', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Harold R', 'Initials': 'HR', 'LastName': 'Collard', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Souheil', 'Initials': 'S', 'LastName': 'El-Chemaly', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Flaherty', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Hunninghake', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Lasky', 'Affiliation': 'Pulmonary and Critical Care Medicine Section, Tulane University Medical School, New Orleans, LA, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Lederer', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Roberto F', 'Initials': 'RF', 'LastName': 'Machado', 'Affiliation': 'Division of Pulmonary, Critical Care, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Noth', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Washington Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Augustine M K', 'Initials': 'AMK', 'LastName': 'Choi', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Joe G N', 'Initials': 'JGN', 'LastName': 'Garcia', 'Affiliation': 'Department of Medicine, University of Arizona Health Sciences, Tucson, AZ, USA. skipgarcia@email.arizona.edu.'}]",Scientific reports,['10.1038/s41598-019-50585-3']
86,32221987,"Long-term safety, efficacy, and quality of life outcomes with adjunctive brivaracetam treatment at individualized doses in patients with epilepsy: An up to 11-year, open-label, follow-up trial.","OBJECTIVE


To evaluate long-term safety/tolerability of brivaracetam at individualized doses ≤200 mg/d (primary) and maintenance of efficacy over time (secondary) in adults with focal seizures or primary generalized seizures (PGS) enrolled in phase 3, open-label, long-term follow-up trial N01199 (NCT00150800).
METHODS


Patients ≥16 years of age who had completed double-blind, placebo-controlled adjunctive brivaracetam trials NCT00175825, NCT00490035, NCT00464269, or NCT00504881 were eligible. Outcomes included safety, efficacy, and quality of life.
RESULTS


The safety set included 667 patients (focal seizures, 97.8%; PGS, 2.2%); the efficacy set included 648 patients with focal seizures and 15 patients with PGS. Overall, 49.2% of patients had ≥48 months of exposure. Treatment-emergent adverse events (TEAEs) occurred in 91.2% of all patients (91.3% of focal seizures group), brivaracetam discontinuation due to TEAEs in 14.8%, drug-related TEAEs in 56.7%, and serious TEAEs in 22.8%. The most common TEAEs in the focal seizures group (≥15%) were headache (25.3%) and dizziness (21.9%). Mean changes from baseline in Hospital Anxiety and Depression Scale scores at last value during 2-year evaluation were -0.7 (standard deviation [SD] = 4.3) and -0.2 (SD = 4.4) overall. In the focal seizures group, median reduction from baseline in focal seizure frequency/28 days was 57.3%, 50% responder rate was 55.6%, and 6-month and 12-month seizure freedom rates were 30.3% and 20.3%, respectively. Efficacy outcomes improved by exposure duration cohort and then stabilized through the 108-month cohort. Mean improvement from baseline in Patient-Weighted Quality of Life in Epilepsy Inventory total score (efficacy set) was 5.7 (SD = 16.1, Cohen's d = 0.35) at month 12 and 6.5 (SD = 18.0, Cohen's d = 0.36) at month 24.
SIGNIFICANCE


Adjunctive brivaracetam was well tolerated, with a good safety profile in long-term use in adults with epilepsy at individualized doses. Approximately half of the patients remained in the trial at 4 years. Brivaracetam reduced focal seizure frequency versus baseline. Efficacy improved with increasing exposure duration and remained stable through the 9-year cohort.",2020,"Treatment-emergent adverse events (TEAEs) occurred in 91.2% of all patients (91.3% of focal seizures group), brivaracetam discontinuation due to TEAEs in 14.8%, drug-related TEAEs in 56.7%, and serious TEAEs in 22.8%.","['patients with epilepsy', '667 patients (focal seizures, 97.8%; PGS, 2.2%); the efficacy set included 648 patients with focal seizures and 15 patients with PGS', 'adults with epilepsy at individualized doses', 'adults with focal seizures or primary generalized seizures (PGS', 'Patients ≥16\xa0years of age who had completed double-blind']","['brivaracetam', 'placebo-controlled adjunctive brivaracetam', 'adjunctive brivaracetam']","['focal seizure frequency', 'headache', 'Long-term safety, efficacy, and quality of life', 'Efficacy outcomes', 'Efficacy', 'brivaracetam discontinuation due to TEAEs', 'seizure freedom rates', 'Patient-Weighted Quality of Life in Epilepsy Inventory total score (efficacy set', 'Hospital Anxiety and Depression Scale scores', 'safety, efficacy, and quality of life', 'dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C4517851', 'cui_str': '667 (qualifier value)'}, {'cui': 'C0751495', 'cui_str': 'Seizures, Focal'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0234533', 'cui_str': 'Generalized convulsion'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0751495', 'cui_str': 'Seizures, Focal'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034380'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",648.0,0.186291,"Treatment-emergent adverse events (TEAEs) occurred in 91.2% of all patients (91.3% of focal seizures group), brivaracetam discontinuation due to TEAEs in 14.8%, drug-related TEAEs in 56.7%, and serious TEAEs in 22.8%.","[{'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Neuroscience, Central Clinical School, Alfred Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Borghs', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'Qin Jane', 'Initials': 'QJ', 'LastName': 'He', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina.'}, {'ForeName': 'Anne-Liv', 'Initials': 'AL', 'LastName': 'Schulz', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Yates', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Biton', 'Affiliation': 'Clinical Trials Inc, Little Rock, Arkansas.'}]",Epilepsia,['10.1111/epi.16484']
87,32312241,"Multidisciplinary lifestyle intervention in children and adolescents - results of the project GRIT (Growth, Resilience, Insights, Thrive) pilot study.","BACKGROUND


During childhood and adolescence leading behavioural risk factors for the development of cardiometabolic diseases include poor diet quality and sedentary lifestyle. The aim of this study was to determine the feasibility and effect of a real-world group-based multidisciplinary intervention on cardiorespiratory fitness, diet quality and self-concept in sedentary children and adolescents aged 9 to 15 years.
METHODS


Project GRIT (Growth, Resilience, Insights, Thrive) was a pilot single-arm intervention study. The 12-week intervention involved up to three outdoor High Intensity Interval Training (HIIT) running sessions per week, five healthy eating education or cooking demonstration sessions, and one mindful eating and Emotional Freedom Technique psychology session. Outcome measures at baseline and 12-week follow-up included maximal graded cardiorespiratory testing, the Australian Child and Adolescent Eating Survey, and Piers-Harris 2 children's self-concept scale. Paired samples t-test or Wilcoxon signed-rank test were used to compare baseline and follow-up outcome measures in study completers only.
RESULTS


Of the 38 recruited participants (median age 11.4 years, 53% male), 24 (63%) completed the 12-week intervention. Dropouts had significantly higher diet quality at baseline than completers. Completers attended a median 58 (IQR 55-75) % of the 33 exercise sessions, 60 (IQR 40-95) % of the dietary sessions, and 42% attended the psychology session. No serious adverse events were reported. Absolute VO 2 peak at 12 weeks changed by 96.2 ± 239.4 mL/min (p = 0.06). As a percentage contribution to energy intake, participants increased their intake of healthy core foods by 6.0 ± 11.1% (p = 0.02) and reduced median intake of confectionary (- 2.0 [IQR 0.0-3.0] %, p = 0.003) and baked products (- 1.0 [IQR 0.0-5.0] %, p = 0.02). Participants significantly improved self-concept with an increase in average T-Score for the total scale by 2.8 ± 5.3 (p = 0.02) and the 'physical appearance and attributes' domain scale by median 4.0 [IQR 0.5-4.0] (p = 0.02).
CONCLUSIONS


The 12-week group-based multidisciplinary lifestyle intervention for children and adolescents improved diet quality and self-concept in study completers. Future practice and research should focus on providing sustainable multidisciplinary lifestyle interventions for children and adolescents aiming to improve long-term health and wellbeing.
TRIAL REGISTRATION


ANZCTR, ACTRN12618001249246. Registered 24 July 2019 - Retrospectively registered.",2020,Absolute VO 2 peak at 12 weeks changed by 96.2 ± 239.4 mL/min (p = 0.06).,"['53% male), 24 (63%) completed the 12-week intervention', 'Registered 24 July 2019 - Retrospectively registered', 'sedentary children and adolescents aged 9 to 15\u2009years', 'Of the 38 recruited participants (median age 11.4\u2009years', 'children and adolescents ']","['outdoor High Intensity Interval Training (HIIT) running sessions per week, five healthy eating education or cooking demonstration sessions, and one mindful eating and Emotional Freedom Technique psychology session', 'real-world group-based multidisciplinary intervention', 'multidisciplinary lifestyle intervention', 'Multidisciplinary lifestyle intervention']","['cardiorespiratory fitness, diet quality and self-concept', ""physical appearance and attributes' domain scale"", 'serious adverse events', 'median intake of confectionary', 'diet quality', 'diet quality and self-concept', 'self-concept', 'Absolute VO 2 peak', 'average T-Score', ""maximal graded cardiorespiratory testing, the Australian Child and Adolescent Eating Survey, and Piers-Harris 2 children's self-concept scale""]","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517533', 'cui_str': '11.4'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0750731', 'cui_str': 'Body, Physical Appearance'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",38.0,0.0405798,Absolute VO 2 peak at 12 weeks changed by 96.2 ± 239.4 mL/min (p = 0.06).,"[{'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Mayr', 'Affiliation': 'Bond University Nutrition and Dietetics Research Group, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Queensland, Australia. hmayr@bond.edu.au.'}, {'ForeName': 'Felicity', 'Initials': 'F', 'LastName': 'Cohen', 'Affiliation': 'Weight Loss Solutions Australia, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Isenring', 'Affiliation': 'Bond University Nutrition and Dietetics Research Group, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Soenen', 'Affiliation': 'Adelaide Medical School, Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Skye', 'Initials': 'S', 'LastName': 'Marshall', 'Affiliation': 'Bond University Nutrition and Dietetics Research Group, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Queensland, Australia.'}]",BMC pediatrics,['10.1186/s12887-020-02069-x']
88,32209449,"Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study.","BACKGROUND


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


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


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


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


Movember and Prostate Cancer Foundation of Australia. VIDEO ABSTRACT.",2020,PSMA PET-CT had a 27% (95% CI 23-31) greater accuracy than that of conventional imaging (92% [88-95] vs 65% [60-69]; p<0·0001).,"['patients with high-risk prostate cancer before curative-intent surgery or', 'staging men with high-risk localised prostate cancer', 'Of 295 (98%) men with follow-up, 87 (30%) had pelvic nodal or distant metastatic disease', 'From March 22, 2017 to Nov 02, 2018, 339 men were assessed for eligibility and 302 men', 'recruited men with biopsy-proven prostate cancer and high-risk features at ten hospitals in Australia', '152 (50%) men']","['novel imaging using prostate-specific membrane antigen (PSMA', 'Prostate-specific membrane antigen PET-CT', 'PSMA PET-CT', 'radiotherapy (proPSMA', 'PET-CT', 'conventional imaging with CT and bone scanning or gallium-68 PSMA-11 PET-CT', 'CT and bone scan']","['accuracy of first-line imaging for identifying either pelvic nodal or distant-metastatic disease defined by the receiver-operating curve using a predefined reference-standard including histopathology, imaging, and biochemistry', 'superiority of PSMA PET-CT', 'lower sensitivity', 'specificity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1310550', 'cui_str': 'prostate-specific membrane antigen, human'}, {'cui': 'C1699633', 'cui_str': 'Positron Emission Tomography Computed Tomography'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0303226', 'cui_str': 'Gallium-68'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0034925', 'cui_str': 'Reference Standards'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0677043', 'cui_str': 'Histopathology (qualifier value)'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C1699633', 'cui_str': 'Positron Emission Tomography Computed Tomography'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",339.0,0.223657,PSMA PET-CT had a 27% (95% CI 23-31) greater accuracy than that of conventional imaging (92% [88-95] vs 65% [60-69]; p<0·0001).,"[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Hofman', 'Affiliation': 'Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia. Electronic address: michael.hofman@petermac.org.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Lawrentschuk', 'Affiliation': 'Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia; Department of Surgery, Austin Health, Melbourne, VIC, Australia; Urological Society of Australia and New Zealand, NSW, Australia.'}, {'ForeName': 'Roslyn J', 'Initials': 'RJ', 'LastName': 'Francis', 'Affiliation': 'Department of Nuclear Medicine, Sir Charles Gairdner Hospital, Perth, WA, Australia; University of Western Australia, Faculty of Health and Medical Sciences, Perth, WA, Australia; ARTnet, NSW, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Vela', 'Affiliation': 'Department of Urology, Princess Alexandra Hospital, Australian Prostate Cancer Research Centre-Queensland, Queensland University of Technology, Translational Research Institute, Brisbane, QLD, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Thomas', 'Affiliation': ""Department of Nuclear Medicine, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia; Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Rutherford', 'Affiliation': 'Department of Nuclear Medicine, Hunter New England Health, Newcastle, NSW, Australia.'}, {'ForeName': 'Jarad M', 'Initials': 'JM', 'LastName': 'Martin', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Frydenberg', 'Affiliation': 'Department of Surgery, Monash University and Cabrini Institute, Cabrini Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Ramdave', 'Initials': 'R', 'LastName': 'Shakher', 'Affiliation': 'Monash Health Imaging, Monash Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Lih-Ming', 'Initials': 'LM', 'LastName': 'Wong', 'Affiliation': ""Department of Urology and Surgery, St Vincent's Health Melbourne, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Taubman', 'Affiliation': ""Department of Medical Imaging, PET/CT and St Vincent's Private Radiology, St Vincent's Health, Melbourne, VIC, Australia.""}, {'ForeName': 'Sze', 'Initials': 'S', 'LastName': 'Ting Lee', 'Affiliation': 'Department of Molecular Imaging and Therapy, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Hsiao', 'Affiliation': 'University of Sydney, Department of Nuclear Medicine and PET, Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Roach', 'Affiliation': 'University of Sydney, Department of Nuclear Medicine and PET, Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Nottage', 'Affiliation': 'Clinical and Research Imaging Centre, South Australian Health and Medical Research Institute, Adelaide, SA, Australia; Dr Jones and Partners Medical Imaging, Adelaide, SA, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Kirkwood', 'Affiliation': 'Department of Nuclear Medicine and PET, Royal Adelaide Hospital, Adelaide, SA, Australia; Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Dickon', 'Initials': 'D', 'LastName': 'Hayne', 'Affiliation': 'UWA Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Link', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Marusic', 'Affiliation': 'Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Anetta', 'Initials': 'A', 'LastName': 'Matera', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Herschtal', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Iravani', 'Affiliation': 'Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Rodney J', 'Initials': 'RJ', 'LastName': 'Hicks', 'Affiliation': 'Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Division of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia; Australian and New Zealand Urogenital and Prostate Cancer Trials Group, NSW, Australia.'}, {'ForeName': 'Declan G', 'Initials': 'DG', 'LastName': 'Murphy', 'Affiliation': 'Division of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30314-7']
89,32303210,Oral nystatin prophylaxis to prevent systemic fungal infection in very low birth weight preterm infants: a randomized controlled trial.,"BACKGROUND


Systemic fungal infection (SFI) is one of leading causes of morbidity and mortality in very low birth weight (VLBW) preterm infants. Because early diagnosis of SFI is challenging due to nonspecific manifestations, prophylaxis becomes crucial. This study aimed to assess effectiveness of oral nystatin as an antifungal prophylaxis to prevent SFI in VLBW preterm infants.
METHODS


A prospective, open-labelled, randomized controlled trial was performed in a neonatal intensive care unit (NICU) of an academic hospital in Indonesia. Infants with a gestational age ≤ 32 weeks and/or birth weight of ≤ 1500 g with risk factors for fungal infection were assessed for eligibility and randomized to either an intervention group (nystatin) or control group. The intervention group received 1 ml of oral nystatin three times a day, and the control group received a dose of 1 ml of sterile water three times a day. The incidence of fungal colonization and SFI were observed and evaluated during the six-week study period. Overall mortality rates and nystatin-related adverse drug reactions during the study period were also documented.
RESULTS


A total of 95 patients were enrolled. The incidence of fungal colonization was lower among infants in nystatin group compared to those in control group (29.8 and 56.3%, respectively; relative risk 0.559; 95% confidence interval 0.357-0.899; p-value = 0.009). There were five cases of SFI, all of which were found in the control group (p-value = 0.056). There was no difference in overall mortality between the two groups. No adverse drug reactions were noted during the study period.
CONCLUSIONS


Nystatin is effective and safe as an antifungal prophylactic medication in reducing colonization rates in the study population. Whilst the use of nystatin showed a potential protective effect against SFI among VLBW preterm infants, there was no statistical significant difference in SFI rates between groups.
TRIAL REGISTRATION


NCT03390374. Registered 4 January 2018 - Retrospectively registered.",2020,There was no difference in overall mortality between the two groups.,"['VLBW preterm infants', 'very low birth weight preterm infants', 'Infants with a gestational age\u2009≤\u200932\u2009weeks', 'Registered 4 January 2018 - Retrospectively registered', 'very low birth weight (VLBW) preterm infants', 'and/or birth weight of ≤\u20091500', '95 patients were enrolled', 'neonatal intensive care unit (NICU) of an academic hospital in Indonesia']","['nystatin', 'oral nystatin', 'intervention group (nystatin) or control group', 'Oral nystatin prophylaxis', '1\u2009ml of oral nystatin', 'Nystatin']","['adverse drug reactions', 'incidence of fungal colonization', 'systemic fungal infection', 'colonization rates', 'overall mortality', 'incidence of fungal colonization and SFI', 'SFI rates', 'Overall mortality rates and nystatin-related adverse drug reactions']","[{'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}]","[{'cui': 'C0028741', 'cui_str': 'Nystatin'}, {'cui': 'C0360389', 'cui_str': 'Nystatin-containing product in oral dose form'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C2826606', 'cui_str': 'Fungal colonisation'}, {'cui': 'C0553576', 'cui_str': 'Systemic mycosis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0028741', 'cui_str': 'Nystatin'}]",95.0,0.209266,There was no difference in overall mortality between the two groups.,"[{'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Rundjan', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital, Jalan Diponegoro 71, DKI Jakarta, 10430, Indonesia. lily_kartono69@yahoo.co.uk.'}, {'ForeName': 'Retno', 'Initials': 'R', 'LastName': 'Wahyuningsih', 'Affiliation': 'Division of Mycology, Department of Parasitology, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital, DKI Jakarta, Indonesia.'}, {'ForeName': 'Chrissela Anindita', 'Initials': 'CA', 'LastName': 'Oeswadi', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital, Jalan Diponegoro 71, DKI Jakarta, 10430, Indonesia.'}, {'ForeName': 'Miske', 'Initials': 'M', 'LastName': 'Marsogi', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital, Jalan Diponegoro 71, DKI Jakarta, 10430, Indonesia.'}, {'ForeName': 'Ayu', 'Initials': 'A', 'LastName': 'Purnamasari', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital, Jalan Diponegoro 71, DKI Jakarta, 10430, Indonesia.'}]",BMC pediatrics,['10.1186/s12887-020-02074-0']
90,31485039,Posterior capsule opacification and Nd:YAG laser rates with two hydrophobic acrylic single-piece IOLs.,"OBJECTIVES


To evaluate the development of posterior capsule opacification (PCO) and Nd:YAG capsulotomy rates following implantation of two hydrophobic acrylic IOLs.
METHODS


In a randomized, controlled trial, 80 patients with bilateral senile cataract were implanted with the hydrophobic acrylic single-piece intraocular Lenses (IOLs) EyeCee One in one eye and iMics1 in the other. Outcomes of 39 patients (78 eyes) were evaluated after 3 years. Automated Quantification of After-Cataract (AQUA; for PCO occurrence), visual acuity, anterior fibrosis, capsule-optic edge interaction and distance between anterior and posterior capsule IOL surface were analysed.
RESULTS


After a mean follow-up of 38 ± 1.95 months, Nd:YAG capsulotomy occurred at a rate of 15.4% and 46.2% in the EyeCee One and iMics1 groups, respectively (p < 0.01). Respective mean PCO scores measured by AQUA were 1.57 ± 1.63 and 2.45 ± 1.44 (p = 0.019). A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes. A gap between the posterior capsule and the posterior surface of the lens was observed in 76% of EyeCee One eyes and 35% of iMics1 eyes.
CONCLUSIONS


Study findings suggest that PCO and Nd:YAG capsulotomy rates are significantly lower in eyes implanted with the EyeCee One IOL compared to the iMics1 IOL. Optic sharpness and lens material seem to be the decisive factors, while the stepped edge beneath the haptic junction appeared to be ineffective.",2020,A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes.,"['80 patients with bilateral senile cataract', '39 patients (78 eyes) were evaluated after 3 years']","['hydrophobic acrylic single-piece intraocular Lenses (IOLs', 'hydrophobic acrylic single-piece IOLs', 'posterior capsule opacification (PCO) and Nd']","['PCO and Nd:YAG capsulotomy rates', 'Respective mean PCO scores', 'visual acuity, anterior fibrosis, capsule-optic edge interaction and distance between anterior and posterior capsule IOL surface', 'IOL optic', 'YAG capsulotomy rates', 'YAG capsulotomy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2025430', 'cui_str': 'Senile cataract of both eyes'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0440181', 'cui_str': 'Acrylic dental material (substance)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0205154', 'cui_str': 'Along edge (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}]",80.0,0.0689483,A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schartmüller', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schriefl', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Schwarzenbacher', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kundi', 'Affiliation': 'Center for Public Health, Medical University of Vienna, Kinderspitalgasse 15, 1090, Vienna, Austria.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Pieh', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria. rupert.menapace@meduniwien.ac.at.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kriechbaum', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}]","Eye (London, England)",['10.1038/s41433-019-0569-x']
91,32324238,Azithromycin Treatment vs Placebo in Children With Respiratory Syncytial Virus-Induced Respiratory Failure: A Phase 2 Randomized Clinical Trial.,"Importance


Despite a high disease burden, there is no effective treatment for respiratory syncytial virus (RSV) infection.
Objectives


To determine whether administration of azithromycin (AZM) to children with RSV-induced respiratory failure is safe and to define the effect of AZM therapy on nasal matrix metalloproteinase 9 (MMP-9) levels.
Design, Setting, and Participants


This randomized, double-blind, placebo-controlled phase 2 trial was conducted at a single tertiary pediatric intensive care unit from February 2016 to February 2019. The study included children with RSV infection who were admitted to the pediatric intensive care unit and required respiratory support via positive pressure ventilation (invasive and noninvasive). A total of 147 children were screened; 90 were excluded for not meeting inclusion criteria, having an absent legal guardian, lacking pharmacy support, or having a language barrier and 9 declined participation, resulting in 48 patients enrolled in the study.
Intervention


Receipt of standard dose AZM (10 mg/kg/d), high-dose AZM (20 mg/kg/d), or a matching placebo of normal saline intravenously for 3 days.
Main Outcomes and Measures


Nasal and endotracheal samples were collected at baseline as well as at 24 hours and 48 hours after start of treatment. The secondary outcome was to determine treatment effect on clinical outcome measures, including days of positive pressure ventilation and length of hospital stay.
Results


A total of 48 patients were enrolled in the trial, with a median (range) age at randomization of 12 (1 to 125) months; 36 participants (75.0%) were younger than 2 years. Overall, 26 participants (54.2%) were boys, and 29 (60.4%) had a comorbidity. A total of 16 patients were randomized into each trial group (ie, placebo, standard-dose AZM, and high-dose AZM). Baseline demographic characteristics were comparable among the 3 groups. Both doses of AZM were safe, with no adverse events observed. No difference in nasal MMP-9 levels were observed between treatment groups. Among those who required mechanical ventilation and received high-dose AZM, endotracheal active and total MMP-9 levels were lower on day 3. Compared with baseline, active and total MMP-9 levels in endotracheal aspirates were 1.0 log lower in the high-dose AZM group (active MMP-9: 99.8% CI, -1.28 to -0.64; P < .001; total MMP-9: 99.8% CI, -1.37 to -0.57; P < .001). Patients who received high-dose AZM had fewer median (interquartile range) hospital days compared with those receiving the placebo (8 [6-14] days vs 11 [8-20] days; mean ratio estimate, 0.57; 95% CI, 0.38-0.87; P = .01).
Conclusions and Relevance


In this phase 2 randomized clinical trial, both doses of AZM were safe. While nasal MMP-9 levels were unchanged among treatment groups, endotracheal MMP-9 levels were lower among those who received high-dose AZM. The positive secondary clinical outcome, while exploratory, provides insight for end points in a multicenter randomized trial.
Trial Registration


ClinicalTrials.gov Identifier: NCT02707523.",2020,"While nasal MMP-9 levels were unchanged among treatment groups, endotracheal MMP-9 levels were lower among those who received high-dose AZM.","['single tertiary pediatric intensive care unit from February 2016 to February 2019', 'children with RSV-induced respiratory failure', 'children with RSV infection who were admitted to the pediatric intensive care unit and required respiratory support via positive pressure ventilation (invasive and noninvasive', '16 patients', 'A total of 147 children were screened; 90 were excluded for not meeting inclusion criteria, having an absent legal guardian, lacking pharmacy support, or having a language barrier and 9 declined participation, resulting in 48 patients enrolled in the study', 'Children With Respiratory Syncytial Virus-Induced Respiratory Failure', '48 patients were enrolled in the trial, with a median (range) age at randomization of 12 (1 to 125) months; 36 participants (75.0%) were younger than 2 years', '26 participants (54.2%) were boys, and 29 (60.4%) had a comorbidity']","['placebo of normal saline intravenously for 3 days', 'AZM therapy', 'azithromycin (AZM', 'standard dose AZM', 'placebo, standard-dose AZM, and high-dose AZM', 'high-dose AZM', 'placebo', 'Azithromycin Treatment vs Placebo', 'AZM']","['endotracheal MMP-9 levels', 'active and total MMP-9 levels', 'days of positive pressure ventilation and length of hospital stay', 'Measures\n\n\nNasal and endotracheal samples', 'endotracheal active and total MMP-9 levels', 'Baseline demographic characteristics', 'nasal MMP-9 levels']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0035235', 'cui_str': 'Respiratory syncytial virus infection'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0237167', 'cui_str': 'Language barrier'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517808', 'cui_str': '54.2'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",147.0,0.764452,"While nasal MMP-9 levels were unchanged among treatment groups, endotracheal MMP-9 levels were lower among those who received high-dose AZM.","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Kong', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}, {'ForeName': 'Wei Wei', 'Initials': 'WW', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Sewell', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Gorman', 'Affiliation': 'McWhorter School of Pharmacy, Samford University, Birmingham, Alabama.'}, {'ForeName': 'Hui-Chien', 'Initials': 'HC', 'LastName': 'Kuo', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Aban', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Whitley', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.3482']
92,31447131,Serious Adverse Effects of Extended-release Niacin/Laropiprant: Results From the Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE) Trial.,"PURPOSE


The Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE) trial of patients at high risk of vascular disease found that adding extended-release niacin-laropiprant to intensive statin-based LDL-lowering therapy had no benefit on cardiovascular outcomes. However, the trial also identified previously unrecognized serious adverse effects (including new-onset diabetes, bleeding, and infection). Our objective was to explore the safety profile of niacin-laropiprant and examine whether any patients were at lower (or higher) risk of its adverse effects.
METHODS


HPS2-THRIVE was a randomized, double-blind trial of niacin-laropiprant (2000/40 mg/d) versus placebo among 25,673 patients at high risk of vascular disease. Information on all serious adverse events was collected during a median of 3.9 years of study treatment. Effects of niacin-laropiprant on new-onset diabetes, disturbances of diabetes control, bleeding, infection, and gastrointestinal upset were estimated by (1) time after randomization, (2) severity, (3) baseline characteristics, (4) baseline risk of the adverse event of interest, and (5) risk of major vascular event.
FINDINGS


The hazard ratio (HR) for new-onset diabetes with niacin/laropiprant was 1.32 (95% CI, 1.16-1.51; P < .001), which corresponded to an absolute excess of 4 people (95% CI, 2-6) developing diabetes per 1000 person-years in the study population as a whole. Among the 8299 participants with diabetes at baseline, the HR for serious disturbances in diabetes control was 1.56 (95% CI, 1.35-1.80), corresponding to an absolute excess of 12 (95% CI, 8-16) per 1000 person-years. The HR was 1.38 (95% CI, 1.17-1.63; P < .001) for serious bleeding, corresponding to an absolute excess of 2 (95% CI, 1-3) per 1000 person-years and 1.22 (95% CI, 1.11-1.34; P < .001) for serious infection, corresponding to an absolute excess of 4 (95% CI, 2-6) per 1000 person-years. The excess risks of these serious adverse events were larger in the first year after starting niacin-laropiprant therapy than in later years (except for the excess of infection, which did not appear to attenuate with time), and the risks of nonfatal and fatal events were similarly increased. The absolute excesses of each of these adverse effects were similar regardless of the baseline risk of the outcome.
IMPLICATIONS


Practitioners or patients considering the use of niacin (in addition to, or instead of, a statin) despite the lack of evidence of cardiovascular benefits (at least when added to effective statin therapy) should take account of the significant risks of these serious adverse effects when making such decisions. ClinicalTrials.gov identifier: NCT00461630.",2019,"The excess risks of these serious adverse events were larger in the first year after starting niacin-laropiprant therapy than in later years (except for the excess of infection, which did not appear to attenuate with time), and the risks of nonfatal and fatal events were similarly increased.","['8299 participants with diabetes', '25,673 patients at high risk of vascular disease', 'patients at high risk of vascular disease found that adding extended-release niacin-laropiprant to intensive statin-based LDL-lowering therapy had no benefit on cardiovascular outcomes']","['niacin', 'placebo', 'Extended-Release Niacin/Laropiprant', 'niacin-laropiprant']","['serious adverse events', 'risks of nonfatal and fatal events', 'serious bleeding', 'hazard ratio (HR', 'new-onset diabetes, disturbances of diabetes control, bleeding, infection, and gastrointestinal upset were estimated by (1) time after randomization, (2) severity, (3) baseline characteristics, (4) baseline risk of the adverse event of interest, and (5) risk of major vascular event']","[{'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C1956497'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1956497'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2697368', 'cui_str': 'Gastrointestinal irritation (disorder)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.379437,"The excess risks of these serious adverse events were larger in the first year after starting niacin-laropiprant therapy than in later years (except for the excess of infection, which did not appear to attenuate with time), and the risks of nonfatal and fatal events were similarly increased.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': 'MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom; Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom. Electronic address: richard.haynes@ndph.ox.ac.uk.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Valdes-Marquez', 'Affiliation': 'Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jemma C', 'Initials': 'JC', 'LastName': 'Hopewell', 'Affiliation': 'Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'National Centre for Cardiovascular Disease, Beijing, China.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Parish', 'Affiliation': 'MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom; Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Landray', 'Affiliation': 'MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom; Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Armitage', 'Affiliation': 'MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom; Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical therapeutics,['10.1016/j.clinthera.2019.06.012']
93,30724693,A Qualitative Study of Serious Illness Conversations in Patients with Advanced Cancer.,"Background:  Conversations with seriously ill patients about their values and goals have been associated with reduced distress, a better quality of life, and goal-concordant care near the end of life. Yet, little is known about how such conversations are conducted.  Objective:  To characterize the content of serious illness conversations and identify opportunities for improvement.  Design:  Qualitative analysis of audio-recorded, serious illness conversations using an evidence-based guide and obtained through a cluster randomized controlled trial in an outpatient oncology setting.  Setting/Measurements:  Clinicians assigned to the intervention arm received training to use the ""Serious Illness Conversation Guide"" to have a serious illness conversation about values and goals with advanced cancer patients. Conversations were de-identified, transcribed verbatim, and independently coded by two researchers. Key themes were analyzed.  Results:  A total of 25 conversations conducted by 16 clinicians were evaluated. The median conversation duration was 14 minutes (range 4-37), with clinicians speaking half of the time. Thematic analyses demonstrated five key themes: (1) supportive dialogue between patients and clinicians; (2) patients' openness to discuss emotionally challenging topics; (3) patients' willingness to articulate preferences regarding life-sustaining treatments; (4) clinicians' difficulty in responding to emotional or ambiguous patient statements; and (5) challenges in discussing prognosis.  Conclusions:  Data from this exploratory study suggest that seriously ill patients are open to discussing values and goals with their clinician. Yet, clinicians may struggle when disclosing a time-based prognosis and in responding to patients' emotions. Such skills should be a focus for additional training for clinicians caring for seriously ill patients.",2019,"Conversations with seriously ill patients about their values and goals have been associated with reduced distress, a better quality of life, and goal-concordant care near the end of life.","['Patients with Advanced Cancer', 'advanced cancer patients', 'seriously ill patients']",[],['median conversation duration'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",16.0,0.0707243,"Conversations with seriously ill patients about their values and goals have been associated with reduced distress, a better quality of life, and goal-concordant care near the end of life.","[{'ForeName': 'Olaf P', 'Initials': 'OP', 'LastName': 'Geerse', 'Affiliation': ""1 Serious Illness Care Program, Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Daniela J', 'Initials': 'DJ', 'LastName': 'Lamas', 'Affiliation': ""1 Serious Illness Care Program, Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Sanders', 'Affiliation': ""1 Serious Illness Care Program, Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Paladino', 'Affiliation': ""1 Serious Illness Care Program, Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kavanagh', 'Affiliation': ""1 Serious Illness Care Program, Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Henrich', 'Affiliation': ""1 Serious Illness Care Program, Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Annette J', 'Initials': 'AJ', 'LastName': 'Berendsen', 'Affiliation': '6 Department of General Practice, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Thijo J N', 'Initials': 'TJN', 'LastName': 'Hiltermann', 'Affiliation': '2 Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Erik K', 'Initials': 'EK', 'LastName': 'Fromme', 'Affiliation': ""1 Serious Illness Care Program, Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Rachelle E', 'Initials': 'RE', 'LastName': 'Bernacki', 'Affiliation': ""1 Serious Illness Care Program, Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Block', 'Affiliation': ""1 Serious Illness Care Program, Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.""}]",Journal of palliative medicine,['10.1089/jpm.2018.0487']
94,31743436,"Assessing the effect of patient navigator assistance for psychosocial support services on health-related quality of life in a randomized clinical trial in Latino breast, prostate, and colorectal cancer survivors.","BACKGROUND


After a diagnosis of prostate, breast, or colorectal cancer, Latinos experience higher mortality rates and lower health-related quality of life (HRQOL) in comparison with other ethnic/racial groups. Patient navigation (PN) and lay community health workers or promotores are effective in increasing cancer screening and early-stage diagnosis among Latinos. However, little is known about the effect of PN on HRQOL among Latino cancer survivors.
METHODS


Latinos previously diagnosed with breast, prostate, or colorectal cancer (n = 288) were randomized to 1 of 2 conditions: 1) the Patient Navigator LIVESTRONG Cancer Navigation Services (PN-LCNS) survivor care program or 2) PN only. HRQOL was measured with the Functional Assessment of Cancer Therapy-General, and cancer-specific HRQOL was measured with the Functional Assessment of Cancer Therapy-Breast, the Functional Assessment of Cancer Therapy-Prostate, and the Functional Assessment of Cancer Therapy-Colorectal for breast, prostate, and colorectal cancer survivors, respectively, at the baseline and at 3 follow-up time points. Generalized estimating equation analyses were conducted to estimate the effect of condition on HRQOL with adjustments for covariates and baseline HRQOL.
RESULTS


PN-LCNS demonstrated a significant improvement in HRQOL in comparison with PN only for colorectal cancer survivors but not for breast and prostate cancer survivors.
CONCLUSIONS


Enhanced PN improves HRQOL among Latino colorectal cancer survivors. Future research should identify the best strategies for engaging Latino survivors in PN programs. PN programs should also be adapted to address HRQOL concerns among Latina breast cancer survivors.",2020,"RESULTS


PN-LCNS demonstrated a significant improvement in HRQOL in comparison with PN only for colorectal cancer survivors but not for breast and prostate cancer survivors.
","['colorectal cancer survivors', 'Latino colorectal cancer survivors', 'Latinos previously diagnosed with breast, prostate, or colorectal cancer (n\xa0=\xa0288', 'Latina breast cancer survivors', 'Latino breast, prostate, and colorectal cancer survivors', 'Latino cancer survivors']","['Enhanced PN', 'patient navigator assistance', 'Patient navigation (PN', 'Patient Navigator LIVESTRONG Cancer Navigation Services (PN-LCNS) survivor care program or 2) PN only']","['HRQOL', 'mortality rates and lower health-related quality of life (HRQOL', 'health-related quality of life', 'Functional Assessment of Cancer Therapy-General, and cancer-specific HRQOL']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C1709488', 'cui_str': 'Patient Navigators'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",,0.0528393,"RESULTS


PN-LCNS demonstrated a significant improvement in HRQOL in comparison with PN only for colorectal cancer survivors but not for breast and prostate cancer survivors.
","[{'ForeName': 'Amelie G', 'Initials': 'AG', 'LastName': 'Ramirez', 'Affiliation': 'Institute for Health Promotion Research, Department of Epidemiology and Biostatistics, Long School of Medicine, University of Texas Health San Antonio, San Antonio, Texas.'}, {'ForeName': 'Byeong Yeob', 'Initials': 'BY', 'LastName': 'Choi', 'Affiliation': 'Department of Epidemiology and Biostatistics, Long School of Medicine, University of Texas Health San Antonio, San Antonio, Texas.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Munoz', 'Affiliation': 'Institute for Health Promotion Research, Department of Epidemiology and Biostatistics, Long School of Medicine, University of Texas Health San Antonio, San Antonio, Texas.'}, {'ForeName': 'Arely', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': 'Institute for Health Promotion Research, Department of Epidemiology and Biostatistics, Long School of Medicine, University of Texas Health San Antonio, San Antonio, Texas.'}, {'ForeName': 'Kipling J', 'Initials': 'KJ', 'LastName': 'Gallion', 'Affiliation': 'Institute for Health Promotion Research, Department of Epidemiology and Biostatistics, Long School of Medicine, University of Texas Health San Antonio, San Antonio, Texas.'}, {'ForeName': 'Patricia I', 'Initials': 'PI', 'LastName': 'Moreno', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Penedo', 'Affiliation': 'Department of Medicine, Miller School of Medicine and College of Arts and Sciences, University of Miami, Miami, Florida.'}]",Cancer,['10.1002/cncr.32626']
95,31647278,Pilot feasibility trial of dual contingency management for cigarette smoking cessation and weight maintenance among weight-concerned female smokers.,"Many women who smoke cigarettes report that concern about weight gain is a barrier to quitting. Indeed, most quitters gain weight and some attribute relapses to weight gain concern. Contingency management (CM), which refers to reinforcing a target behavior with financial incentives, has been demonstrated effective for promoting smoking abstinence and weight management independently. We conducted a pilot trial to establish the feasibility of dual CM, in which both smoking cessation and weight maintenance were incentivized, as a smoking cessation intervention for female weight-concerned smokers. Participants ( N  = 10) received a 12-week intervention during which they earned financial incentives for smoking abstinence, verified by breath carbon monoxide (CO) testing, and for maintaining their weight (larger incentives for gaining less than five pounds, smaller incentives for 5-10 pound gain) while abstaining from smoking. They attended an end of intervention visit at week 13 and a follow-up visit at week 26. Total compensation was up to $550 ($255 for participation independent of smoking and weight, $145 for smoking abstinence incentives, and $150 for weight maintenance incentives). Results indicated that five of the 10 participants (50%) were continuously abstinent for at least 4 weeks and received at least 2 weight maintenance incentives. Three participants (33%) were abstinent at every visit they attended from quit date through week 26; 2 of these 3 had gained more than 10 pounds by week 26. Additional formative research to test alternative incentive schedules and modalities should be conducted before CM-W is evaluated in a larger trial. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Contingency management (CM), which refers to reinforcing a target behavior with financial incentives, has been demonstrated effective for promoting smoking abstinence and weight management independently.","['female weight-concerned smokers', 'Three participants (33%) were abstinent at every visit they attended from quit date through week 26; 2 of these 3 had gained more than 10 pounds by week 26', 'weight-concerned female smokers', 'Participants ( N  = 10']","['smoking cessation intervention', '12-week intervention during which they earned financial incentives for smoking abstinence, verified by breath carbon monoxide (CO) testing, and for maintaining their weight (larger incentives for gaining less than five pounds, smaller incentives for 5-10 pound gain) while abstaining from smoking', 'Contingency management (CM', 'dual contingency management']",['Total compensation'],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0332273', 'cui_str': 'Through (qualifier value)'}, {'cui': 'C0205172', 'cui_str': 'More (qualifier value)'}, {'cui': 'C0439219', 'cui_str': 'lb'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}]",2019.0,0.017117,"Contingency management (CM), which refers to reinforcing a target behavior with financial incentives, has been demonstrated effective for promoting smoking abstinence and weight management independently.","[{'ForeName': 'Erika Litvin', 'Initials': 'EL', 'LastName': 'Bloom', 'Affiliation': 'Alpert Medical School of Brown University.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hunt', 'Affiliation': 'Rhode Island Hospital.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Tidey', 'Affiliation': 'Brown University School of Public Health.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Ramsey', 'Affiliation': 'Alpert Medical School of Brown University.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000331']
96,32326827,Melatonin suppression during a simulated night shift in medium intensity light is increased by 10-minute breaks in dim light and decreased by 10-minute breaks in bright light.,"Exposure to light at night results in disruption of endogenous circadian rhythmicity and/or suppression of pineal melatonin, which can consequently lead to acute or chronic adverse health problems. In the present study, we investigated whether exposure to very dim light or very bright light for a short duration influences melatonin suppression, subjective sleepiness, and performance during exposure to constant moderately bright light. Twenty-four healthy male university students were divided into two experimental groups: Half of them (mean age: 20.0 ± 0.9 years) participated in an experiment for short-duration (10 min) light conditions of medium intensity light (430 lx, medium breaks) vs. very dim light (< 1 lx, dim breaks) and the other half (mean age: 21.3 ± 2.5 years) participated in an experiment for short-duration light conditions of medium intensity light (430 lx, medium breaks) vs. very bright light (4700 lx, bright breaks). Each simulated night shift consisting of 5 sets (each including 50-minute night work and 10-minute break) was performed from 01:00 to 06:00 h. The subjects were exposed to medium intensity light (550 lx) during the night work. Each 10-minute break was conducted every hour from 02:00 to 06:00 h. Salivary melatonin concentrations were measured, subjective sleepiness was assessed, the psychomotor vigilance task was performed at hourly intervals from 21:00 h until the end of the experiment. Compared to melatonin suppression between 04:00 and 06:00 h in the condition of medium breaks, the condition of dim breaks significantly promoted melatonin suppression and the condition of bright breaks significantly diminished melatonin suppression. However, there was no remarkable effect of either dim breaks or bright breaks on subjective sleepiness and performance of the psychomotor vigilance task. Our findings suggest that periodic exposure to light for short durations during exposure to a constant light environment affects the sensitivity of pineal melatonin to constant light depending on the difference between light intensities in the two light conditions (i.e., short light exposure vs. constant light exposure). Also, our findings indicate that exposure to light of various intensities at night could be a factor influencing the light-induced melatonin suppression in real night work settings.",2020,"However, there was no remarkable effect of either dim breaks or bright breaks on subjective sleepiness and performance of the psychomotor vigilance task.",['Twenty-four healthy male university students were divided into two experimental groups: Half of them (mean age: 20.0\xa0±\xa00.9\xa0years) participated in an'],"['experiment for short-duration (10\xa0min) light conditions of medium intensity light (430\xa0lx, medium breaks) vs. very dim light (< 1\xa0lx, dim breaks) and the other half (mean age: 21.3\xa0±\xa02.5\xa0years) participated in an experiment for short-duration light conditions of medium intensity light (430\xa0lx, medium breaks) vs. very bright light (4700\xa0lx, bright breaks']","['Salivary melatonin concentrations', 'subjective sleepiness and performance of the psychomotor vigilance task', 'subjective sleepiness', 'Melatonin suppression', 'psychomotor vigilance task']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",24.0,0.0191275,"However, there was no remarkable effect of either dim breaks or bright breaks on subjective sleepiness and performance of the psychomotor vigilance task.","[{'ForeName': 'Sang-Il', 'Initials': 'SI', 'LastName': 'Lee', 'Affiliation': 'Department of Human Science, Faculty of Design, Kyushu University , Fukuoka, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Kansei Science, Graduate School of Integrated Frontier Science, Kyushu University , Fukuoka, Japan.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Noguchi', 'Affiliation': 'Department of Kansei Science, Graduate School of Integrated Frontier Science, Kyushu University , Fukuoka, Japan.'}, {'ForeName': 'Taisuke', 'Initials': 'T', 'LastName': 'Eto', 'Affiliation': 'Department of Kansei Science, Graduate School of Integrated Frontier Science, Kyushu University , Fukuoka, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Ohashi', 'Affiliation': 'Department of Kansei Science, Graduate School of Integrated Frontier Science, Kyushu University , Fukuoka, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Nishimura', 'Affiliation': 'Department of Kansei Science, Graduate School of Integrated Frontier Science, Kyushu University , Fukuoka, Japan.'}, {'ForeName': 'Kaho', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'Ground Facilities Department, Japan Aerospace Exploration Agency , Tsukuba, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Motomura', 'Affiliation': 'Department of Human Science, Faculty of Design, Kyushu University , Fukuoka, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Awata', 'Affiliation': 'Ground Facilities Department, Japan Aerospace Exploration Agency , Tsukuba, Japan.'}, {'ForeName': 'Shigekazu', 'Initials': 'S', 'LastName': 'Higuchi', 'Affiliation': 'Department of Human Science, Faculty of Design, Kyushu University , Fukuoka, Japan.'}]",Chronobiology international,['10.1080/07420528.2020.1752704']
97,32282044,Effects of a Telehealth Early Palliative Care Intervention for Family Caregivers of Persons With Advanced Heart Failure: The ENABLE CHF-PC Randomized Clinical Trial.,"Importance


Family caregivers of persons with advanced heart failure perform numerous daily tasks to assist their relatives and are at high risk for distress and poor quality of life.
Objective


To determine the effect of a nurse-led palliative care telehealth intervention (Educate, Nurture, Advise, Before Life Ends Comprehensive Heart Failure for Patients and Caregivers [ENABLE CHF-PC]) on quality of life and mood of family caregivers of persons with New York Heart Association Class III/IV heart failure over 16 weeks.
Design, Setting, and Participants


This single-blind randomized clinical trial enrolled caregivers aged 18 years and older who self-identified as an unpaid close friend or family member who knew the patient well and who was involved with their day-to-day medical care. Participants were recruited from outpatient heart failure clinics at a large academic tertiary care medical center and a Veterans Affairs medical center from August 2016 to October 2018.
Intervention


Four weekly psychosocial and problem-solving support telephonic sessions lasting between 20 and 60 minutes facilitated by a trained nurse coach plus monthly follow-up for 48 weeks. The usual care group received no additional intervention.
Main Outcomes and Measures


The primary outcomes were quality of life (measured using the Bakas Caregiver Outcomes Scale), mood (anxiety and/or depressive symptoms measured using the Hospital Anxiety and Depression Scale), and burden (measured using the Montgomery-Borgatta Caregiver Burden scales) over 16 weeks. Secondary outcomes were global health (measured using the PROMIS Global Health instrument) and positive aspects of caregiving.
Results


A total of 158 family caregivers were randomized, 82 to the intervention and 76 to usual care. The mean (SD) age was 57.9 (11.6) years, 135 (85.4%) were female, 82 (51.9%) were African American, and 103 (65.2%) were the patient's spouse or partner. At week 16, the mean (SE) Bakas Caregiver Outcomes Scale score was 66.9 (2.1) in the intervention group and 63.9 (1.7) in the usual care group; over 16 weeks, the mean (SE) Bakas Caregiver Outcomes Scale score improved 0.7 (1.7) points in the intervention group and 1.1 (1.6) points in the usual care group (difference, -0.4; 95% CI, -5.1 to 4.3; Cohen d = -0.03). At week 16, no relevant between-group differences were observed between the intervention and usual care groups for the Hospital Anxiety and Depression Scale anxiety measure (mean [SE] improvement from baseline, 0.3 [0.3] vs 0.4 [0.3]; difference, -0.1 [0.5]; d = -0.02) or depression measure (mean [SE] improvement from baseline, -0.2 [0.4] vs -0.3 [0.3]; difference, 0.1 [0.5]; d = 0.03). No between-group differences were observed in the Montgomery-Borgatta Caregiver Burden scales (d range, -0.18 to 0.0). Differences in secondary outcomes were also not significant (d range, -0.22 to 0.0).
Conclusions and Relevance


This 2-site randomized clinical trial of a telehealth intervention for family caregivers of patients with advanced heart failure, more than half of whom were African American and most of whom were not distressed at baseline, did not demonstrate clinically better quality of life, mood, or burden compared with usual care over 16 weeks. Future interventions should target distressed caregivers and assess caregiver effects on patient outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT02505425.",2020,"At week 16, no relevant between-group differences were observed between the intervention and usual care groups for the Hospital Anxiety and Depression Scale anxiety measure (mean [SE] improvement from baseline, 0.3 [0.3] vs 0.4 [0.3]; difference, -0.1 [0.5]; d = -0.02) or depression measure (mean [SE] improvement from baseline, -0.2","['Importance\n\n\nFamily caregivers of persons with advanced heart failure', ""The mean (SD) age was 57.9 (11.6) years, 135 (85.4%) were female, 82 (51.9%) were African American, and 103 (65.2%) were the patient's spouse or partner"", 'family caregivers of patients with advanced heart failure, more than half of whom were African American and most of whom were not distressed at baseline, did not demonstrate clinically better quality of life, mood, or burden compared with usual care over 16 weeks', 'caregivers aged 18 years and older who self-identified as an unpaid close friend or family member who knew the patient well and who was involved with their day-to-day medical care', 'Family Caregivers of Persons With Advanced Heart Failure', '158 family caregivers', 'Participants were recruited from outpatient heart failure clinics at a large academic tertiary care medical center and a Veterans Affairs medical center from August 2016 to October 2018', 'family caregivers of persons with New York Heart Association Class III/IV heart failure over 16 weeks']","['Telehealth Early Palliative Care Intervention', 'Intervention\n\n\nFour weekly psychosocial and problem-solving support telephonic sessions lasting between 20 and 60 minutes facilitated by a trained nurse coach plus monthly follow-up for 48 weeks', 'usual care group received no additional intervention', 'telehealth intervention', 'nurse-led palliative care telehealth intervention']","['global health (measured using the PROMIS Global Health instrument) and positive aspects of caregiving', 'Montgomery-Borgatta Caregiver Burden scales', 'mean (SE) Bakas Caregiver Outcomes Scale score', 'Hospital Anxiety and Depression Scale anxiety measure', 'quality of life (measured using the Bakas Caregiver Outcomes Scale), mood (anxiety and/or depressive symptoms measured using the Hospital Anxiety and Depression Scale), and burden (measured using the Montgomery-Borgatta Caregiver Burden scales']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",158.0,0.108224,"At week 16, no relevant between-group differences were observed between the intervention and usual care groups for the Hospital Anxiety and Depression Scale anxiety measure (mean [SE] improvement from baseline, 0.3 [0.3] vs 0.4 [0.3]; difference, -0.1 [0.5]; d = -0.02) or depression measure (mean [SE] improvement from baseline, -0.2","[{'ForeName': 'J Nicholas', 'Initials': 'JN', 'LastName': 'Dionne-Odom', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Deborah B', 'Initials': 'DB', 'LastName': 'Ejem', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wells', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Macy L', 'Initials': 'ML', 'LastName': 'Stockdill', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Konda', 'Initials': 'K', 'LastName': 'Keebler', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sockwell', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Tims', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Engler', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kvale', 'Affiliation': 'Department of Medicine, Dell Medical School, The University of Texas at Austin.'}, {'ForeName': 'Raegan W', 'Initials': 'RW', 'LastName': 'Durant', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Rodney O', 'Initials': 'RO', 'LastName': 'Tucker', 'Affiliation': 'Center for Palliative and Supportive Care, Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Burgio', 'Affiliation': 'Birmingham Veterans Affairs Medical Center, Birmingham, Alabama.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Tallaj', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Salpy V', 'Initials': 'SV', 'LastName': 'Pamboukian', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Swetz', 'Affiliation': 'Center for Palliative and Supportive Care, Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Bakitas', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.2583']
98,32286643,Effect of a Chikungunya Virus-Like Particle Vaccine on Safety and Tolerability Outcomes: A Randomized Clinical Trial.,"Importance


Chikungunya virus (CHIKV) is a mosquito-borne Alphavirus prevalent worldwide. There are currently no licensed vaccines or therapies.
Objective


To evaluate the safety and tolerability of an investigational CHIKV virus-like particle (VLP) vaccine in endemic regions.
Design, Setting, and Participants


This was a randomized, placebo-controlled, double-blind, phase 2 clinical trial to assess the vaccine VRC-CHKVLP059-00-VP (CHIKV VLP). The trial was conducted at 6 outpatient clinical research sites located in Haiti, Dominican Republic, Martinique, Guadeloupe, and Puerto Rico. A total of 400 healthy adults aged 18 through 60 years were enrolled after meeting eligibility criteria. The first study enrollment occurred on November 18, 2015; the final study visit, March 6, 2018.
Interventions


Participants were randomized 1:1 to receive 2 intramuscular injections 28 days apart (20 µg, n = 201) or placebo (n = 199) and were followed up for 72 weeks.
Main Outcomes and Measures


The primary outcome was the safety (laboratory parameters, adverse events, and CHIKV infection) and tolerability (local and systemic reactogenicity) of the vaccine, and the secondary outcome was immune response by neutralization assay 4 weeks after second vaccination.
Results


Of the 400 randomized participants (mean age, 35 years; 199 [50%] women), 393 (98%) completed the primary safety analysis. All injections were well tolerated. Of the 16 serious adverse events unrelated to the study drugs, 4 (25%) occurred among 4 patients in the vaccine group and 12 (75%) occurred among 11 patients in the placebo group. Of the 16 mild to moderate unsolicited adverse events that were potentially related to the drug, 12 (75%) occurred among 8 patients in the vaccine group and 4 (25%) occurred among 3 patients in the placebo group. All potentially related adverse events resolved without clinical sequelae. At baseline, there was no significant difference between the effective concentration (EC50)-which is the dilution of sera that inhibits 50% infection in viral neutralization assay-geometric mean titers (GMTs) of neutralizing antibodies of the vaccine group (46; 95% CI, 34-63) and the placebo group (43; 95% CI, 32-57). Eight weeks following the first administration, the EC50 GMT in the vaccine group was 2005 (95% CI, 1680-2392) vs 43 (95% CI, 32-58; P < .001) in the placebo group. Durability of the immune response was demonstrated through 72 weeks after vaccination.
Conclusions and Relevance


Among healthy adults in a chikungunya endemic population, a virus-like particle vaccine compared with placebo demonstrated safety and tolerability. Phase 3 trials are needed to assess clinical efficacy.
Trial Registration


ClinicalTrials.gov Identifier: NCT02562482.",2020,"At baseline, there was no significant difference between the effective concentration (EC50)-which is the dilution of sera that inhibits 50% infection in viral neutralization assay-geometric mean titers (GMTs) of neutralizing antibodies of the vaccine group (46; 95% CI, 34-63) and the placebo group (43; 95% CI, 32-57).","['endemic regions', 'healthy adults in a chikungunya endemic population', '400 healthy adults aged 18 through 60 years were enrolled after meeting eligibility criteria', '400 randomized participants (mean age, 35 years; 199 [50%] women), 393 (98%) completed the primary safety analysis', '6 outpatient clinical research sites located in Haiti, Dominican Republic, Martinique, Guadeloupe, and Puerto Rico']","['Chikungunya Virus-Like Particle Vaccine', 'vaccine VRC-CHKVLP059-00-VP (CHIKV VLP', 'placebo', 'investigational CHIKV virus-like particle (VLP) vaccine']","['EC50 GMT', 'tolerated', 'safety and tolerability', 'safety (laboratory parameters, adverse events, and CHIKV infection) and tolerability (local and systemic reactogenicity', 'Safety and Tolerability Outcomes']","[{'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0008055', 'cui_str': 'Chikungunya fever'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}, {'cui': 'C0013014', 'cui_str': 'Dominican Republic'}, {'cui': 'C0024853', 'cui_str': 'Martinique'}, {'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}]","[{'cui': 'C0008056', 'cui_str': 'Chikungunya virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0333785', 'cui_str': 'Virus-like particles'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0008055', 'cui_str': 'Chikungunya fever'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",400.0,0.684011,"At baseline, there was no significant difference between the effective concentration (EC50)-which is the dilution of sera that inhibits 50% infection in viral neutralization assay-geometric mean titers (GMTs) of neutralizing antibodies of the vaccine group (46; 95% CI, 34-63) and the placebo group (43; 95% CI, 32-57).","[{'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'Chen', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Coates', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Plummer', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Cristina A', 'Initials': 'CA', 'LastName': 'Carter', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Berkowitz', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Conan-Cibotti', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Josephine H', 'Initials': 'JH', 'LastName': 'Cox', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Beck', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': ""O'Callahan"", 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Charla', 'Initials': 'C', 'LastName': 'Andrews', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Ingelise J', 'Initials': 'IJ', 'LastName': 'Gordon', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Larkin', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lampley', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Kaltovich', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Gall', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Carlton', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Mendy', 'Affiliation': 'Emergent BioSolutions, San Diego, California.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Haney', 'Affiliation': 'Emergent BioSolutions, San Diego, California.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'May', 'Affiliation': 'The Emmes Company, Rockville, Maryland.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Bray', 'Affiliation': 'The Emmes Company, Rockville, Maryland.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Bailer', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Dowd', 'Affiliation': 'Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Brittanie', 'Initials': 'B', 'LastName': 'Brockett', 'Affiliation': 'Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gordon', 'Affiliation': 'Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Koup', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schwartz', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Mascola', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Barney S', 'Initials': 'BS', 'LastName': 'Graham', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Theodore C', 'Initials': 'TC', 'LastName': 'Pierson', 'Affiliation': 'Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Yeycy', 'Initials': 'Y', 'LastName': 'Donastorg', 'Affiliation': 'Instituto Dermatologico y Cirugia de Piel (IDCP), Dominican Republic.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rosario', 'Affiliation': 'San Juan Hospital, Puerto Rico.'}, {'ForeName': 'Jean William', 'Initials': 'JW', 'LastName': 'Pape', 'Affiliation': ""The Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (Centres GHESKIO), Haiti.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Hoen', 'Affiliation': ""INSERM Centre d'Investigation Clinique (CIC) 1424, Centre Hospitalier Universitaire (CHU) de la Guadeloupe, France.""}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Cabié', 'Affiliation': ""INSERM Centre d'Investigation Clinique (CIC) 1424, Centre Hospitalier Universitaire (CHU) de Martinique, France.""}, {'ForeName': 'Clemente', 'Initials': 'C', 'LastName': 'Diaz', 'Affiliation': 'PR Clinical and Translational Research Consortium (PRCTRC), Puerto Rico.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Ledgerwood', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.2477']
99,32286644,Effect of Preemptive Therapy vs Antiviral Prophylaxis on Cytomegalovirus Disease in Seronegative Liver Transplant Recipients With Seropositive Donors: A Randomized Clinical Trial.,"Importance


Despite the use of a cytomegalovirus (CMV) prevention strategy of antiviral prophylaxis for high-risk CMV-seronegative liver transplant recipients with seropositive donors, high rates of delayed-onset postprophylaxis CMV disease occur. An alternate approach, preemptive therapy (initiation of antiviral therapy for early asymptomatic CMV viremia detected by surveillance testing), has not previously been directly compared with antiviral prophylaxis in these patients.
Objective


To compare preemptive therapy with antiviral prophylaxis in CMV-seronegative liver transplant recipients with seropositive donors for the prevention of CMV disease.
Design, Setting, and Participants


Randomized clinical trial of preemptive therapy vs antiviral prophylaxis in 205 CMV-seronegative liver transplant recipients with seropositive donors aged older than 18 years. The trial was conducted at 6 academic transplant centers in the United States between October 2012 and June 2017, with last follow-up in June 2018.
Interventions


Patients were randomized 1:1 to receive either preemptive therapy (valganciclovir, 900 mg, twice daily until 2 consecutive negative tests a week apart) for viremia detected by weekly plasma CMV polymerase chain reaction for 100 days (n = 100) or valganciclovir, 900 mg, daily for 100 days as antiviral prophylaxis (n = 105).
Main Outcomes and Measures


The primary outcome was incidence of CMV disease by 12 months, defined as CMV syndrome (CMV viremia and clinical or laboratory findings) or end-organ disease. Secondary outcomes included acute allograft rejection, opportunistic infections, graft and patient survival, and neutropenia.
Results


Among 205 patients who were randomized (mean age, 55 years; 62 women [30%]), all 205 (100%) completed the trial. The incidence of CMV disease was significantly lower with preemptive therapy than antiviral prophylaxis (9% [9/100] vs 19% [20/105]; difference, 10% [95% CI, 0.5% to 19.6%]; P = .04]). The incidence of allograft rejection (28% vs 25%; difference, 3% [95% CI, -9% to 15%]), opportunistic infections (25% vs 27%; difference, 2% [95% CI, -14% to 10%]), graft loss (2% vs 2%; difference, <1% [95% CI, -4% to 4%]), and neutropenia (13% vs 10%; difference, 3% [95% CI, -5% to 12%]) did not differ significantly for the preemptive therapy vs antiviral prophylaxis group, respectively. All-cause mortality at last follow-up was 15% in the preemptive therapy vs 19% in the antiviral prophylaxis group (difference, 4% [95% CI, -14% to 6%]; P = .46).
Conclusions and Relevance


Among CMV-seronegative liver transplant recipients with seropositive donors, the use of preemptive therapy, compared with antiviral prophylaxis, resulted in a lower incidence of CMV disease over 12 months. Further research is needed to replicate these findings and assess long-term outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT01552369.",2020,"All-cause mortality at last follow-up was 15% in the preemptive therapy vs 19% in the antiviral prophylaxis group (difference, 4% [95% CI, -14% to 6%]; P = .46).
","['Seronegative Liver Transplant Recipients', ' 62 women [30%]), all 205 (100%) completed the trial', '205 patients who were randomized (mean age, 55 years', 'CMV-seronegative liver transplant recipients with seropositive donors', 'high-risk CMV-seronegative liver transplant recipients with seropositive donors', 'CMV-seronegative liver transplant recipients with seropositive donors for the prevention of CMV disease', 'With Seropositive Donors', '205 CMV-seronegative liver transplant recipients with seropositive donors aged older than 18 years', '6 academic transplant centers in the United States between October 2012 and June 2017, with last follow-up in June 2018']","['cytomegalovirus (CMV', 'Preemptive Therapy vs Antiviral Prophylaxis', 'preemptive therapy (valganciclovir, 900 mg, twice daily until 2 consecutive negative tests a week apart) for viremia detected by weekly plasma CMV polymerase chain reaction', 'valganciclovir', 'antiviral prophylaxis', 'preemptive therapy vs antiviral prophylaxis']","['acute allograft rejection, opportunistic infections, graft and patient survival, and neutropenia', 'opportunistic infections', 'incidence of CMV disease', 'graft loss', 'incidence of allograft rejection', 'neutropenia', 'CMV disease', 'Cytomegalovirus Disease', 'incidence of CMV disease by 12 months, defined as CMV syndrome (CMV viremia and clinical or laboratory findings) or end-organ disease']","[{'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0455647', 'cui_str': 'H/O: liver recipient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0877137', 'cui_str': 'Antiviral prophylaxis'}, {'cui': 'C0909381', 'cui_str': 'valganciclovir'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}]","[{'cui': 'C1735634', 'cui_str': 'Acute allograft rejection'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1112469', 'cui_str': 'Cytomegalovirus syndrome'}, {'cui': 'C0877635', 'cui_str': 'Cytomegalovirus viremia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.112,"All-cause mortality at last follow-up was 15% in the preemptive therapy vs 19% in the antiviral prophylaxis group (difference, 4% [95% CI, -14% to 6%]; P = .46).
","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Drew J', 'Initials': 'DJ', 'LastName': 'Winston', 'Affiliation': 'University of California Los Angeles Medical Center, Los Angeles.'}, {'ForeName': 'Raymund R', 'Initials': 'RR', 'LastName': 'Razonable', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'G Marshall', 'Initials': 'GM', 'LastName': 'Lyon', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Fernanda P', 'Initials': 'FP', 'LastName': 'Silveira', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Marilyn M', 'Initials': 'MM', 'LastName': 'Wagener', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Stevens-Ayers', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Edmison', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boeckh', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Ajit P', 'Initials': 'AP', 'LastName': 'Limaye', 'Affiliation': 'University of Washington, Seattle.'}]",JAMA,['10.1001/jama.2020.3138']
100,32286659,Effects of a Tailored Brief Behavioral Therapy Application on Insomnia Severity and Social Disabilities Among Workers With Insomnia in Japan: A Randomized Clinical Trial.,"Importance


According to the stepped-care model, there is a medium to large effect size for using cognitive behavioral therapy for insomnia that is delivered digitally, such as a smartphone application. However, it has been reported that studies using fully automated cognitive behavioral therapy for insomnia applications without expert support have high dropout rates.
Objective


To examine the effects of using a fully automated and individually tailored brief behavior therapy for insomnia (BBTI) applications for 2 weeks on insomnia-related symptoms, social disabilities, and work productivity among workers with insomnia in Japan.
Design, Setting, and Participants


This intent-to-treat prospective parallel-group randomized clinical trial included participants 20 years or older with Insomnia Severity Index (ISI) scores of 8 or higher. Participants were recruited via internet advertisements and workplace flyers and randomized to tailored BBTI, standard BBTI, self-monitoring with sleep diaries, or a waiting list control group. The study was conducted from September 21, 2017, to February 23, 2018. Data were analyzed from February 24, 2018, to February 22, 2019.
Interventions


A personalized BBTI and standard BBTI intervention, both of which included sleep scheduling, relaxation, sleep hygiene, and sleep diaries, administered via smartphone application.
Main Outcomes and Measures


Primary outcomes were insomnia severity, measured using the Japanese version of the Insomnia Severity Index, and social disabilities, measured using the Japanese version of the Sheehan Disability Scale. Secondary outcomes were dysfunctional beliefs, sleep reactivity, and work productivity. All measures were taken before and after the intervention and at 1-month and 3-month follow-ups.
Results


A total of 92 participants (mean [SD] age, 42.7 [11.5] years; 60 [65%] men) were randomized and included in analysis, with 24 participants assigned to tailored BBTI, 23 participants assigned to standard BBTI, 23 participants assigned to self-monitoring, and 22 participants assigned to the waiting list control group. At baseline, there were no significant differences among groups on any demographic characteristics or outcome measures. The results of the intent-to-treat analysis showed an interaction effect for all outcome measures. Compared with the waiting list control group, the BBTI interventions were more effective for reduction of insomnia severity (tailored BBTI: Hedges g = -1.64 [95% CI, -2.32 to -0.96]; P < .001; standard BBTI: g = -1.28 [95% CI, -1.93 to -0.63]; P < .001), social disabilities relating to social life (tailored BBTI: g = -1.33 [95% CI, -1.97 to -0.68]; P < .001; standard BBTI: g = -0.84 [95% CI, -1.46 to -0.22]; P = .009), and dysfunctional beliefs (tailored BBTI: g = -1.17 [95% CI, -1.80 to -0.54]; P < .001; standard BBTI: g = -0.84 [95% CI, -1.46 to -0.23]; P = .02) at the 3-month follow-up. Tailored BBTI quickly reduced insomnia severity (1-month follow-up: g = -0.85 [95% CI, -1.46 to -0.24]). Tailored BBTI was only more effective for improvement of work performance (g = -1.09 [95% CI, -1.71 to -0.46]; P = .005), social disabilities related to family life (g = -0.89 [95% CI, -1.51 to -0.28]; P = .005), and sleep reactivity (g = -1.09 [95% CI, -1.72 to -0.46]; P = .007) compared with the waiting list control group at the 3-month follow-up. The tailored BBTI led to improved worker productivity compared with standard BBTI (g = 0.94 [95% CI, 0.33 to 1.55]; P = .01) at the 3-month follow-up.
Conclusions and Relevance


These findings suggest that an application for individually tailored BBTI is an inexpensive and effective treatment for insomnia. In future research, it would be informative to investigate the reasons for dropout during the follow-up period.
Trial Registration


umin.ac.jp/ctr Identifier: UMIN000036572.",2020,"Tailored BBTI was only more effective for improvement of work performance (g = -1.09 [95% CI, -1.71 to -0.46]; P = .005), social disabilities related to family life (g = -0.89","['workers with insomnia in Japan', 'September 21, 2017, to February 23, 2018', 'Data were analyzed from February 24, 2018, to February 22, 2019', 'participants 20 years or older with Insomnia Severity Index (ISI) scores of 8 or higher', 'Participants were recruited via internet advertisements and workplace flyers and randomized to', 'Workers With Insomnia in Japan', '92 participants (mean [SD] age, 42.7 [11.5] years; 60 [65%] men']","['fully automated and individually tailored brief behavior therapy', 'waiting list control group', 'Tailored Brief Behavioral Therapy Application', 'tailored BBTI, standard BBTI, self-monitoring with sleep diaries, or a waiting list control group']","['Insomnia Severity and Social Disabilities', 'dysfunctional beliefs, sleep reactivity, and work productivity', 'insomnia severity (tailored BBTI', 'worker productivity', 'insomnia severity, measured using the Japanese version of the Insomnia Severity Index, and social disabilities, measured using the Japanese version of the Sheehan Disability Scale', 'social disabilities relating to social life (tailored BBTI', 'insomnia severity', 'work performance', 'social disabilities related to family life', 'sleep reactivity', 'dysfunctional beliefs (tailored BBTI']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0015608', 'cui_str': 'Family Relationship'}]",92.0,0.0727328,"Tailored BBTI was only more effective for improvement of work performance (g = -1.09 [95% CI, -1.71 to -0.46]; P = .005), social disabilities related to family life (g = -0.89","[{'ForeName': 'Isa', 'Initials': 'I', 'LastName': 'Okajima', 'Affiliation': 'Department of Psychological Counseling, Faculty of Humanities, Tokyo Kasei University, Tokyo, Japan.'}, {'ForeName': 'Jou', 'Initials': 'J', 'LastName': 'Akitomi', 'Affiliation': 'NEC Solution Innovators Ltd, Tokyo, Japan.'}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Kajiyama', 'Affiliation': 'NEC Solution Innovators Ltd, Tokyo, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Ishii', 'Affiliation': 'Senzoku Stress Coping Support Office, Tokyo, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Murakami', 'Affiliation': 'NEC VALWAY Ltd, Tokyo, Japan.'}, {'ForeName': 'Mineko', 'Initials': 'M', 'LastName': 'Yamaguchi', 'Affiliation': 'NEC Solution Innovators Ltd, Tokyo, Japan.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.2775']
101,31867650,Effects of 6-Week Use of Very Low Nicotine Content Cigarettes in Smokers With Serious Mental Illness.,"INTRODUCTION


The US Food and Drug Administration is considering implementing a reduced-nicotine standard for cigarettes. Given the high rate of smoking among people with serious mental illness (SMI), it is important to examine the responses of these smokers to very low nicotine content (VLNC) cigarettes.
METHODS


This trial compared the effects of VLNC (0.4 mg nicotine/g tobacco) and normal nicotine content cigarettes (15.8 mg/g) over a 6-week period in non-treatment-seeking smokers with schizophrenia, schizoaffective disorder, or bipolar disorder (n = 58). Linear regression was used to examine the effects of cigarette condition on cigarettes per day, subjective responses, nicotine and tobacco toxicant exposure, craving, withdrawal symptoms, and psychiatric symptoms.
RESULTS


At week 6, participants in the VLNC condition smoked fewer cigarettes per day, had lower breath carbon monoxide levels, lower craving scores, and rated their study cigarettes lower in satisfaction, reward, enjoyment, and craving reduction than those in the normal nicotine content condition (ps < .05). Week 6 psychiatric and extrapyramidal symptoms did not differ by condition, except for scores on a measure of parkinsonism, which were lower in the VLNC condition (p < .05). There were no differences across conditions on total nicotine exposure, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, withdrawal symptoms, or responses to abstinence.
CONCLUSIONS


These results suggest that a reduced-nicotine standard for cigarettes would reduce smoking among smokers with SMI. However, the lack of effect on total nicotine exposure indicates VLNC noncompliance, suggesting that smokers with SMI may respond to a reduced-nicotine standard by substituting alternative forms of nicotine.
IMPLICATIONS


Results from this trial suggest that a reduced-nicotine standard for cigarettes would reduce smoking rates and smoke exposure in smokers with SMI, without increasing psychiatric symptoms. However, noncompliance with VLNC cigarettes was observed, suggesting that these smokers might respond to a reduced-nicotine standard by substituting alternative forms of nicotine.",2019,"Week 6 psychiatric and extrapyramidal symptoms did not differ by condition, except for scores on a measure of parkinsonism, which were lower in the VLNC condition (p < .05).","['Smokers With Serious Mental Illness', 'people with serious mental illness (SMI', 'smokers with SMI', 'non-treatment-seeking smokers with schizophrenia, schizoaffective disorder, or bipolar disorder (n = 58']","['Very Low Nicotine Content Cigarettes', 'nicotine/g tobacco) and normal nicotine content cigarettes', 'VLNC']","['smoking rates and smoke exposure', 'total nicotine exposure, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, withdrawal symptoms, or responses to abstinence', 'lower breath carbon monoxide levels, lower craving scores, and rated their study cigarettes lower in satisfaction, reward, enjoyment, and craving reduction', 'cigarettes per day, subjective responses, nicotine and tobacco toxicant exposure, craving, withdrawal symptoms, and psychiatric symptoms', 'extrapyramidal symptoms']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}]","[{'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0389836', 'cui_str': '4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign (finding)'}]",,0.0162502,"Week 6 psychiatric and extrapyramidal symptoms did not differ by condition, except for scores on a measure of parkinsonism, which were lower in the VLNC condition (p < .05).","[{'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Colby', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Denlinger-Apte', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Goodwin', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cioe', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Rachel N', 'Initials': 'RN', 'LastName': 'Cassidy', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Swift', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Lindgren', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Rubin', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Hecht', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz133']
102,32102910,The Impact of Exclusive Use of Very Low Nicotine Cigarettes on Compensatory Smoking: An Inpatient Crossover Clinical Trial.,"BACKGROUND


The FDA is considering a mandated reduction in the nicotine content of cigarettes. Clinical trials have been limited by non-study cigarette use (noncompliance), which could mask compensation. The goal of this study was to assess whether compensation occurs when smokers provided with very low nicotine cigarettes cannot access normal nicotine cigarettes.
METHODS


In a within-subjects, crossover design, current smokers ( n  = 16) were confined to a hotel for two 4-night hotel stays during which they were only able to access the research cigarettes provided. The hotel stays offered normal nicotine cigarettes or very low nicotine content (VLNC) cigarettes, in an unblinded design, available for ""purchase"" via a study bank.
RESULTS


In the context of complete compliance with the study cigarettes ( n  = 16), there was not a significant increase during the VLNC condition for cigarettes smoked per day, expired carbon monoxide, or N-acetyl-S-(cyanoethyl)-l-cysteine (cyanoethyl-MA, metabolite of acrylonitrile). There was a significant nicotine × time interaction on urine N-acetyl-S-(3-hydroxypropyl)-l-cysteine (hydroxypropyl-MA, metabolite of acrolein), driven by an increase in the VLNC condition during the first 24 hours. By the end of the VLNC condition, there was no evidence of compensation across any measure of smoking or smoke exposure.
CONCLUSIONS


Among current smokers who exclusively used VLNC cigarettes for 4 days, there was no significant compensatory smoking behavior.
IMPACT


These data, combined with the larger body of work, suggest that a mandated reduction in nicotine content is unlikely to result in an increase in smoking behavior to obtain more nicotine.",2020,"By the end of the VLNC condition, there was no evidence of compensation across any measure of smoking or smoke exposure.
",[],"['Very Low Nicotine Cigarettes', 'normal nicotine cigarettes or very low nicotine content (VLNC) cigarettes']","['VLNC condition for cigarettes smoked per day, expired carbon monoxide, or N-acetyl-S-(cyanoethyl)-l-cysteine (cyanoethyl-MA, metabolite of acrylonitrile', 'smoking behavior', 'Compensatory Smoking', 'urine N-acetyl-S-(3-hydroxypropyl)-l-cysteine (hydroxypropyl-MA, metabolite of acrolein', 'compensatory smoking behavior']",[],"[{'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke (substance)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0067663', 'cui_str': 'N-acetyl-S-(carboxymethyl)-L-cysteine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0001223', 'cui_str': 'Vinyl Cyanide'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0042037'}, {'cui': 'C0073815', 'cui_str': ""2-acetamido-3-(3'-hydroxypropylthio)propanoic acid""}, {'cui': 'C0001204', 'cui_str': 'Acraldehyde'}]",16.0,0.0199532,"By the end of the VLNC condition, there was no evidence of compensation across any measure of smoking or smoke exposure.
","[{'ForeName': 'Tracy T', 'Initials': 'TT', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, and Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina. smithtra@musc.edu.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Koopmeiners', 'Affiliation': 'Division of Biostatistics, School of Public Health, and Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Cassidy M', 'Initials': 'CM', 'LastName': 'White', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Denlinger-Apte', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Pacek', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Víctor R', 'Initials': 'VR', 'LastName': 'De Jesús', 'Affiliation': 'Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Lanqing', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Watson', 'Affiliation': 'Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Blount', 'Affiliation': 'Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Department of Psychiatry and Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Departments of Medicine and Bioengineering & Therapeutic Sciences, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, and Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-0963']
103,31594394,Acute Hemodynamic Responses to Repetitions to Failure Using Different Resistance Exercises and Protocols in Normotensive Men: A crossover study.,"The present crossover design study investigated acute hemodynamic responses to two sets of leg press (LP) and bench press (BeP) at 10 and 20 repetition maximum (RM) in ten normotensive young men. At the end of each set, an increase in systolic blood pressure (SBP), heart rate (HR), and rate pressure product (RPP) was observed ( p  < .01), with no differences between intensities, but SBP was greater during the LP exercise ( p  < .01). Lower resting values of diastolic blood pressure (DBP) were observed in the post-BeP exercise period ( p  < .05), suggesting that DBP post-exercise hypotension may be more evident after upper-limb exercise.",2020,"Lower resting values of diastolic blood pressure (DBP) were observed in the post-BeP exercise period ( p  < .05), suggesting that DBP post-exercise hypotension may be more evident after upper-limb exercise.","['ten normotensive young men', 'Normotensive Men']","['leg press (LP) and bench press (BeP) at 10 and 20 repetition maximum (RM', 'Resistance Exercises and Protocols']","['diastolic blood pressure (DBP', 'systolic blood pressure (SBP), heart rate (HR), and rate pressure product (RPP']","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",,0.0188219,"Lower resting values of diastolic blood pressure (DBP) were observed in the post-BeP exercise period ( p  < .05), suggesting that DBP post-exercise hypotension may be more evident after upper-limb exercise.","[{'ForeName': 'Carlos Leonardo Figueiredo', 'Initials': 'CLF', 'LastName': 'Machado', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul - Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Bgeginski', 'Affiliation': 'R. Samuel McLaughlin Foundation - Exercise and Pregnancy Lab, School of Kinesiology, The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Clarissa', 'Initials': 'C', 'LastName': 'De Castro', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul - Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Eurico Nestor', 'Initials': 'EN', 'LastName': 'Wilhelm', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul - Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Ronei Silveira', 'Initials': 'RS', 'LastName': 'Pinto', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul - Porto Alegre, Rio Grande do Sul, Brazil.'}]","Clinical and experimental hypertension (New York, N.Y. : 1993)",['10.1080/10641963.2019.1676772']
104,30964385,Integrating Advance Care Planning Videos into Surgical Oncologic Care: A Randomized Clinical Trial.,"Background:  Preoperative advance care planning (ACP) may benefit patients undergoing major surgery.  Objective:  To evaluate feasibility, safety, and early effectiveness of video-based ACP in a surgical population.  Design:  Randomized controlled trial with two study arms.  Setting:  Single, academic, inner-city tertiary care hospital.  Subjects:  Patients undergoing major cancer surgery were recruited from nine surgical clinics. Of 106 consecutive potential participants, 103 were eligible and 92 enrolled.  Interventions:  In the intervention arm, patients viewed an ACP video developed by patients, surgeons, palliative care clinicians, and other stakeholders. In the control arm, patients viewed an informational video about the hospital's surgical program.  Measurements:  Primary Outcomes-ACP content and patient-centeredness in patient-surgeon preoperative conversation. Secondary outcomes-patient Hospital Anxiety and Depression Scale (HADS) score; patient goals of care; patient and surgeon satisfaction; video helpfulness; and medical decision maker designation.  Results:  Ninety-two patients (target enrollment: 90) were enrolled. The ACP video was successfully integrated with no harm noted. Patient-centeredness was unchanged (incidence rate ratio [IRR] = 1.06, confidence interval [0.87-1.3],  p  = 0.545), although there were more ACP discussions in the intervention arm (23% intervention vs. 10% control,  p  = 0.18). While slightly underpowered, study results did not signal that further enrollment would have yielded statistical significance. There were no differences in secondary outcomes other than the intervention video was more helpful ( p  = 0.007).  Conclusions:  The ACP video was successfully integrated into surgical care without harm and was thought to be helpful, although video content did not significantly change the ACP content or patient-surgeon communication. Future studies could increase the ACP dose through modifying video content and/or who presents ACP. Trial Registration: clinicaltrials.gov Identifier NCT02489799.",2019,There were no differences in secondary outcomes other than the intervention video was more helpful ( p  = 0.007).  ,"['Patients undergoing major cancer surgery were recruited from nine surgical clinics', 'Results:  Ninety-two patients (target enrollment: 90) were enrolled', 'Subjects', 'patients undergoing major surgery', '106 consecutive potential participants, 103 were eligible and 92 enrolled']","[':  Preoperative advance care planning (ACP', 'ACP video', 'video-based ACP']","['ACP content and patient-centeredness in patient-surgeon preoperative conversation', 'patient Hospital Anxiety and Depression Scale (HADS) score; patient goals of care; patient and surgeon satisfaction; video helpfulness; and medical decision maker designation', 'ACP discussions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0920424'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0554244', 'cui_str': 'Maker (occupation)'}]",,0.140405,There were no differences in secondary outcomes other than the intervention video was more helpful ( p  = 0.007).  ,"[{'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Aslakson', 'Affiliation': '1 Palliative Care Section, Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Sarina R', 'Initials': 'SR', 'LastName': 'Isenberg', 'Affiliation': '3 Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Norah L', 'Initials': 'NL', 'LastName': 'Crossnohere', 'Affiliation': '3 Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Conca-Cheng', 'Affiliation': '5 Department of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': '5 Department of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Bhamidipati', 'Affiliation': '5 Department of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': '5 Department of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': '6 Patient/Family Member Co-Investigator, Ellicott City, Maryland.'}, {'ForeName': 'Sarabdeep', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': '5 Department of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Swoboda', 'Affiliation': '7 Department of Surgery, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Pawlik', 'Affiliation': '8 Department of Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': '7 Department of Surgery, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Volandes', 'Affiliation': '9 Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': '10 Department of Oncology and Palliative Care Program, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'John F P', 'Initials': 'JFP', 'LastName': 'Bridges', 'Affiliation': '8 Department of Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Roter', 'Affiliation': '3 Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]",Journal of palliative medicine,['10.1089/jpm.2018.0209']
105,31628475,Smoking Topography Characteristics During a 6-Week Trial of Very Low Nicotine Content Cigarettes in Smokers With Serious Mental Illness.,"INTRODUCTION


A nicotine-reduction policy could have major benefits for smokers with serious mental illness (SMI). However, potential unintended consequences, such as compensatory smoking, should be considered to ensure that such a policy does not negatively affect this population. The purpose of this secondary analysis was to examine the impact of smoking very low nicotine content (VLNC) cigarettes for 6 weeks on smoking topography characteristics, indicators of compensatory smoking, among smokers with SMI.
AIMS AND METHODS


After a baseline usual brand smoking phase, smokers with SMI (N = 58) were randomly assigned under double-blind conditions to receive either VLNC (0.4 mg nicotine per g tobacco) or normal nicotine content (NNC; 15.8 mg nicotine per g tobacco) research cigarettes for 6 weeks. During two study visits scheduled 6 weeks apart, participants smoked either their usual brand (baseline) or assigned study cigarettes (postrandomization) through a handheld smoking topography device. Univariate analysis of variance compared smoking topography indices with cigarette condition (VLNC vs. NNC) as the between-subjects factor with corresponding baseline topography results included as covariates.
RESULTS


At week 6, participants in the VLNC condition smoked fewer puffs per cigarette and had shorter interpuff intervals compared to participants in the NNC condition (ps < .05). There were no differences between research cigarette conditions at week 6 for cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost.
CONCLUSIONS


Findings are consistent with acute VLNC cigarette topography studies and indicate that a nicotine-reduction policy is unlikely to lead to compensation among smokers with SMI.
IMPLICATIONS


Given the high smoking rates among people with SMI, understanding how a nicotine-reduction policy may affect this population is critically important. When considering the smoking topography results as a whole, smokers with SMI did not engage in compensatory smoking behavior when using VLNC cigarettes during a 6-week trial. Study findings suggest that compensatory smoking is not likely to occur among smokers with SMI if nicotine content is lowered to minimally addictive levels.",2020,"There were no differences between research cigarette conditions at Week 6 for cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost.
","['smokers with SMI (N=58', 'smokers with serious mental illness (SMI', 'smokers with serious mental illness', 'smokers with SMI']","['smoking very low nicotine content (VLNC) cigarettes', 'VLNC (0.4 mg nicotine/g tobacco) or normal nicotine content (NNC; 15.8 mg/g) research cigarettes for six weeks', 'nicotine content cigarettes', 'handheld smoking topography device']","['cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost', 'VLNC condition smoked fewer puffs per cigarette and had shorter inter-puff intervals']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0035168'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1533107', 'cui_str': 'Puffs'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0729283', 'cui_str': 'Peak flow rate (respiratory)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.0201706,"There were no differences between research cigarette conditions at Week 6 for cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost.
","[{'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Denlinger-Apte', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Baptist Comprehensive Cancer Center and Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Lindgren', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Rubin', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Goodwin', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'DeAtley', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Colby', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cioe', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center and Department of Psychiatry, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, RI.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz198']
106,32149887,Varying the Order of Combinations of Single- and Multi-Joint Exercises Differentially Affects Resistance Training Adaptations.,"Brandão, L, de Salles Painelli, V, Lasevicius, T, Silva-Batista, C, Brendon, H, Schoenfeld, BJ, Aihara, AY, Cardoso, FN, de Almeida Peres, B, and Teixeira, EL. Varying the order of combinations of single- and multi-joint exercises differentially affects resistance training adaptations. J Strength Cond Res 34(5): 1254-1263, 2020-Our study aimed to compare the effects of multi-joint (MJ) and single-joint (SJ) exercises, either isolated or in combination, and in different orders, on cross-sectional area (CSA) of the pectoralis major (PM) and different heads of the triceps brachii (TB), as well as on the one-repetition maximum (1-RM) in the bench press and lying barbell triceps press. Forty-three young men were randomly assigned to one of 4 possible RT protocols: barbell bench press plus lying barbell triceps press (MJ + SJ, n = 12); lying barbell triceps press plus barbell bench press (SJ + MJ, n = 10); barbell bench press (MJ, n = 10); or lying barbell triceps press (SJ, n = 11). Results showed significant within-group increases in 1-RM bench press for MJ, MJ + SJ, and SJ + MJ but not for SJ. Conversely, significantly greater within-group increases in elbow extension 1-RM were noted for SJ, MJ + SJ, and SJ + MJ but not for MJ. Significantly greater increases in PM CSA were observed for MJ, MJ + SJ, and SJ + MJ compared with SJ. Significant increases in TB CSA were noted for SJ, MJ + SJ, and SJ + MJ, but not for MJ, without observed between-group differences. Individual analysis of TB heads showed significantly greater CSA increases in the lateral head for MJ, MJ + SJ, and SJ + MJ compared with SJ. Alternatively, significantly greater increases in the long head were observed for SJ, MJ + SJ, and SJ + MJ compared with MJ. CSA increases for the medial head were statistically similar between conditions. Our findings indicate that muscular adaptations are differentially affected by performance of MJ and SJ exercises.",2020,"Individual analysis of TB heads showed significantly greater CSA increases in the lateral head for MJ, MJ + SJ, and SJ + MJ compared with SJ.",['Forty-three young men'],"['Single- and Multi-Joint Exercises', '4 possible RT protocols: barbell bench press plus lying barbell triceps press (MJ + SJ, n = 12); lying barbell triceps press plus barbell bench press (SJ + MJ, n = 10); barbell bench press (MJ, n = 10); or lying barbell triceps press', 'J Strength Cond Res XX(X', 'multi-joint (MJ) and single-joint (SJ) exercises, either isolated or in combination, and in different orders, on cross-sectional area (CSA) of the pectoralis major (PM) and different heads of the triceps brachii (TB']","['PM CSA', 'Brandão, L, de Salles Painelli, V, Lasevicius, T, Silva-Batista, C, Brendon, H, Schoenfeld, BJ, Aihara, AY, Cardoso, FN', 'CSA', 'CSA increases for the medial head', '1-RM bench press for MJ, MJ + SJ, and SJ + MJ', 'elbow extension 1-RM', 'TB CSA']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}]","[{'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]",43.0,0.0242924,"Individual analysis of TB heads showed significantly greater CSA increases in the lateral head for MJ, MJ + SJ, and SJ + MJ compared with SJ.","[{'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Brandão', 'Affiliation': 'Strength Training Study and Research Group, Paulista University, UNIP, São Paulo, SP-Brazil.'}, {'ForeName': 'Vitor', 'Initials': 'V', 'LastName': 'de Salles Painelli', 'Affiliation': 'Strength Training Study and Research Group, Paulista University, UNIP, São Paulo, SP-Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Lasevicius', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, SP-Brazil.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Silva-Batista', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, SP-Brazil.'}, {'ForeName': 'Helderson', 'Initials': 'H', 'LastName': 'Brendon', 'Affiliation': 'Strength Training Study and Research Group, Paulista University, UNIP, São Paulo, SP-Brazil.'}, {'ForeName': 'Brad Jon', 'Initials': 'BJ', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Health Sciences, CUNY Lehman College, Bronx, New York.'}, {'ForeName': 'André Yui', 'Initials': 'AY', 'LastName': 'Aihara', 'Affiliation': 'Delboni Auriemo Laboratory, DASA, São Paulo, SP-Brazil.'}, {'ForeName': 'Fabiano Nassar', 'Initials': 'FN', 'LastName': 'Cardoso', 'Affiliation': 'Delboni Auriemo Laboratory, DASA, São Paulo, SP-Brazil.'}, {'ForeName': 'Bergson', 'Initials': 'B', 'LastName': 'de Almeida Peres', 'Affiliation': 'Strength Training Study and Research Group, Paulista University, UNIP, São Paulo, SP-Brazil.'}, {'ForeName': 'Emerson Luiz', 'Initials': 'EL', 'LastName': 'Teixeira', 'Affiliation': 'Strength Training Study and Research Group, Paulista University, UNIP, São Paulo, SP-Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003550']
107,32295554,"Study protocol: NeoCLEAR: Neonatal Champagne Lumbar punctures Every time - An RCT: a multicentre, randomised controlled 2 × 2 factorial trial to investigate techniques to increase lumbar puncture success.","BACKGROUND


The neonatal period carries the highest risk of bacterial meningitis (~ 1 in 5000 births), bearing high mortality (~ 10%) and morbidity (20-50%) rates. Lumbar puncture (LP) remains essential to the diagnosis of meningitis. Though LP is a common procedure in neonates, success rates are lower (50-60%) than in other patient populations. None of the currently-practised neonatal LP techniques are supported by evidence from adequately-powered, randomised controlled trials (RCTs). NeoCLEAR aims to compare two modifications to the traditional technique which are free, accessible, and commonly practised: sitting (as opposed to lying) position, and 'early' (as opposed to 'late') stylet removal.
METHODS/DESIGN


Written parental informed consent permitting, infants in neonatal/maternity wards, of 27 + 0  to 44 + 0  weeks corrected gestational age and weighing ≥1000 g, who require an LP, will be randomly allocated to sitting or lying position, and to early or late stylet removal. The co-primary objectives are to compare success rates (the proportion of infants with cerebrospinal fluid red cell count < 10,000/mm 3  on first LP procedure) in 1020 infants between the two positions, and between the two methods of stylet removal. Secondary outcomes relate to LP procedures, complications, diagnoses of meningitis, duration of antibiotics and hospital stay. A modified intention-to-treat analysis will be conducted.
DISCUSSION


Two modifications to the traditional LP technique (sitting vs lying position; and early vs late stylet removal) will be simultaneously investigated in an efficient and appropriately-powered 2 × 2 factorial RCT design. Analysis will identify the optimal techniques (in terms of obtaining easily-interpretable cerebrospinal fluid), as well as the impact on infants, parents and healthcare systems whilst providing robust safety data. Using a pragmatic RCT design, all practitioners will be trained in all LP techniques, but there will inevitably be variation between unit practice guidelines and other aspects of individual care. An improved LP technique would result in: • Fewer uninterpretable samples, repeated attempts and procedures • Reduced distress for infants and families • Decreased antibiotic use and risk of antibiotic resistance • Reduced healthcare costs due to fewer procedures, reduced length of stay, shorter antibiotic courses, and minimised antibiotic-associated complications TRIAL REGISTRATION: ISRCTN14040914. Date assigned: 26/06/2018.",2020,"Reduced healthcare costs due to fewer procedures, reduced length of stay, shorter antibiotic courses, and minimised antibiotic-associated complications TRIAL REGISTRATION: ISRCTN14040914.","['infants and families •', 'Written parental informed consent permitting, infants in neonatal/maternity wards, of 27 +\u20090  to 44 +\u20090  weeks corrected gestational age and weighing ≥1000\u2009g, who require an LP']","['Champagne Lumbar punctures', 'Lumbar puncture (LP', 'traditional LP technique (sitting vs lying position; and early vs late stylet removal']","['Reduced distress', 'LP procedures, complications, diagnoses of meningitis, duration of antibiotics and hospital stay', 'morbidity', 'Decreased antibiotic use and risk of antibiotic resistance •', 'healthcare costs', 'lumbar puncture success', 'length of stay, shorter antibiotic courses, and minimised antibiotic-associated complications']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}]","[{'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0444334', 'cui_str': 'Recumbent body position'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0183663', 'cui_str': 'Stylet'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",1020.0,0.194449,"Reduced healthcare costs due to fewer procedures, reduced length of stay, shorter antibiotic courses, and minimised antibiotic-associated complications TRIAL REGISTRATION: ISRCTN14040914.","[{'ForeName': 'Andrew S J', 'Initials': 'ASJ', 'LastName': 'Marshall', 'Affiliation': 'Department of Paediatrics, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Headley Way, Headington, Oxford, OX3 9DU, UK. a.marshall@doctors.org.uk.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Sadarangani', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital Research Institute, Vancouver, BC, V5Z 4H4, Canada.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Scrivens', 'Affiliation': 'Newborn Care Unit, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Headley Way, Headington, Oxford, OX3 9DU, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'National Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Yong', 'Affiliation': 'Newborn Care Unit, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Headley Way, Headington, Oxford, OX3 9DU, UK.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Bowler', 'Affiliation': 'National Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': 'National Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Chiocchia', 'Affiliation': 'National Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Bell', 'Affiliation': 'National Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Caz', 'Initials': 'C', 'LastName': 'Stokes', 'Affiliation': ""Support for the Sick Newborn And their Parents (SSNAP) Charity, Level 2, The Women's Centre, John Radcliffe Hospital, Oxford, OX3 9DU, UK.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Santhanadass', 'Affiliation': ""Support for the Sick Newborn And their Parents (SSNAP) Charity, Level 2, The Women's Centre, John Radcliffe Hospital, Oxford, OX3 9DU, UK.""}, {'ForeName': 'Eleri', 'Initials': 'E', 'LastName': 'Adams', 'Affiliation': 'Newborn Care Unit, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Headley Way, Headington, Oxford, OX3 9DU, UK.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': 'National Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Roehr', 'Affiliation': 'Newborn Care Unit, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Headley Way, Headington, Oxford, OX3 9DU, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pediatrics,['10.1186/s12887-020-02050-8']
108,31701153,Very Low Nicotine Content Cigarettes Disrupt the Feedback Loop of Affective States and Smoking Behavior.,"INTRODUCTION


Smoking to reduce negative affect has been identified as a key motivational feature of tobacco use. Our recent work suggests that smoking very low nicotine content (VLNC) cigarettes reduces the relationship between negative affect and smoking behavior over a 6-week period. Here, we sought to extend our findings by evaluating whether a gradual or immediate approach to switching to VLNC cigarettes led to a differential reduction in the relationship between affect and smoking behavior over a longer (20-week) period.
AIMS AND METHODS


Participants (n = 1250) were adult smokers from 10 US sites randomized to one of three groups: gradual nicotine reduction (15.5, 11.7, 5.2, 2.4, and 0.4 mg of nicotine per gram of tobacco [mg/g]), immediate nicotine reduction (0.4 mg/g), or standard nicotine content cigarettes (15.5 mg/g; control), for 20 weeks. We examined whether the relationship between affect-both negative and positive-and cigarettes per day differed as a function of reduction group.
RESULTS


We found that both negative and positive affect were associated with cigarette consumption in the control group, but not in the gradual or immediate reduction groups across the 20 weeks of exposure.
CONCLUSIONS


Our results extend previous findings that switching to VLNC cigarettes disrupts the relationship between affect and cigarette consumption by showing that either gradually or immediately reducing cigarette nicotine content achieves this disruption. These findings provide further evidence that switching to VLNC cigarettes reduces nicotine-related reinforcement of cigarette smoking.
IMPLICATIONS


These findings support the notion that switching to very low nicotine content cigarettes reduces the association between affect and smoking behavior, and that either a gradual or immediate nicotine reduction approach achieves this reduction. This provides further evidence that switching to very low nicotine content cigarettes weakens reinforcement mechanisms associated with nicotine dependence.",2020,"We found that both negative and positive affect were associated with cigarette consumption in the control group but not in the gradual or immediate reduction groups across the 20 weeks of exposure.
",['Participants (n=1250) were adult smokers from ten U.S. sites randomized to one of three groups'],"['nicotine per gram of tobacco [mg/g]), immediate nicotine reduction', 'gradual nicotine reduction', 'standard nicotine content cigarettes']",['cigarette consumption'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0459840', 'cui_str': 'Cigarette consumption (observable entity)'}]",,0.010842,"We found that both negative and positive affect were associated with cigarette consumption in the control group but not in the gradual or immediate reduction groups across the 20 weeks of exposure.
","[{'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Robinson', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Kypriotakis', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': ""Al'absi"", 'Affiliation': 'Department of Family Medicine and BioBehavioral Health, University of Minnesota Medical School, Duluth, MN.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Denlinger-Apte', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Drobes', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Leischow', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ.'}, {'ForeName': 'F Joseph', 'Initials': 'FJ', 'LastName': 'McClernon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Pacek', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Herbert H', 'Initials': 'HH', 'LastName': 'Severson', 'Affiliation': 'Oregon Research Institute, Eugene, OR.'}, {'ForeName': 'Tracy T', 'Initials': 'TT', 'LastName': 'Smith', 'Affiliation': 'Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Cancer Prevention and Control, Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Joni A', 'Initials': 'JA', 'LastName': 'Jensen', 'Affiliation': 'Cancer Prevention and Control, Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Lori G', 'Initials': 'LG', 'LastName': 'Strayer', 'Affiliation': 'Cancer Prevention and Control, Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Cinciripini', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Cancer Prevention and Control, Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz209']
109,30395532,Risk Assessment of Recreational Noise-Induced Hearing Loss from Exposure through a Personal Audio System-iPod Touch.,"BACKGROUND


Recreational noise-induced hearing loss (RNIHL) is a major health issue and presents a huge economic burden on society. Exposure to loud music is not considered hazardous in our society because music is thought to be a source of relaxation and entertainment. However, there is evidence that regardless of the sound source, frequent exposure to loud music, including through personal audio systems (PAS), can lead to hearing loss, tinnitus, difficulty processing speech, and increased susceptibility to age-related hearing loss.
PURPOSE


Several studies have documented temporary threshold shifts (TTS) (a risk indicator of future permanent impairment) in subjects that listen to loud music through their PAS. However, there is not enough information regarding volume settings that may be considered to be safe. As a primary step toward quantifying the risk of RNIHL through PAS, we assessed changes in auditory test measures before and after exposure to music through the popular iPod Touch device set at various volume levels.
RESEARCH DESIGN


This project design incorporated aspects of both between- and within-subjects and used repeated measures to analyze individual groups.
STUDY SAMPLE


A total of 40 adults, aged 18-31 years with normal hearing were recruited and randomly distributed to four groups. Each group consisted of five males and five females.
DATA COLLECTION AND ANALYSIS


Subjects underwent two rounds of testing (pre- and postmusic exposure), with a 30-min interval, where they listened to a playlist consisting of popular songs through an iPod at 100%, 75%, 50%, or 0% volume (no music). Based on our analysis on the Knowles Electronic Manikin for Acoustic Research, with a standardized 711 coupler, it was determined that listening to the playlist for 30 min through standard earbuds resulted in an average level of 97.0 dBC at 100% volume, 83.3 dBC at 75% volume, and 65.6 dBC at 50% volume. Pure-tone thresholds from 500-8000 Hz, extended high-frequency pure tones between 9-12.5 kHz, and distortion product otoacoustic emissions (DPOAE) were obtained before and after the 30-min music exposure. Analysis of variance (ANOVA) was performed with two between-subjects factors (volume and gender) and one within-subjects factor (frequency). Change (shift) in auditory test measures was used as the outcome for the ANOVA.
RESULTS


Results indicated significant worsening of pure-tone thresholds following music exposure only in the group that was exposed to 100% volume at the following frequencies: 2, 3, 4, 6 and 8 kHz. DPOAEs showed significant decrease at 2000 and 2822 Hz, also only for the 100% volume condition. No significant changes were found between pre- and postmusic exposure measures in groups exposed to 75%, 50%, or 0% volume conditions. Follow-up evaluations conducted a week later indicated that pure-tone thresholds had returned to the premusic exposure levels.
CONCLUSIONS


These results provide quantifiable information regarding safe volume control settings on the iPod Touch with standard earbuds. Listening to music using the iPod Touch at 100% volume setting for as little as 30 min leads to TTS and worsening of otoacoustic emissions, a risk for permanent auditory damage.",2019,"No significant changes were found between pre- and postmusic exposure measures in groups exposed to 75%, 50%, or 0% volume conditions.","['subjects that listen to loud music through their PAS', '40 adults, aged 18-31 years with normal hearing', 'Subjects underwent two rounds of testing (pre- and postmusic exposure']","['Recreational noise-induced hearing loss (RNIHL', 'Recreational Noise-Induced Hearing Loss from Exposure through a Personal Audio System-iPod Touch']","['Change (shift) in auditory test measures', 'pure-tone thresholds', 'pre- and postmusic exposure measures']","[{'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1384666', 'cui_str': 'Hypoacusis'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C2350434', 'cui_str': 'iPOD'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",40.0,0.041616,"No significant changes were found between pre- and postmusic exposure measures in groups exposed to 75%, 50%, or 0% volume conditions.","[{'ForeName': 'Kamakshi V', 'Initials': 'KV', 'LastName': 'Gopal', 'Affiliation': 'Department of Audiology and Speech-Language Pathology, University of North Texas, Denton, TX.'}, {'ForeName': 'Liana E', 'Initials': 'LE', 'LastName': 'Mills', 'Affiliation': 'Department of Audiology and Speech-Language Pathology, University of North Texas, Denton, TX.'}, {'ForeName': 'Bryce S', 'Initials': 'BS', 'LastName': 'Phillips', 'Affiliation': 'Department of Audiology and Speech-Language Pathology, University of North Texas, Denton, TX.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Nandy', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of North Texas Health Science Center, Fort Worth, TX.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.17140']
110,32189338,"Pregabalin adjunctive therapy for focal onset seizures in children 1 month to <4 years of age: A double-blind, placebo-controlled, video-electroencephalographic trial.","OBJECTIVE


To evaluate the efficacy and safety of pregabalin as adjunctive treatment for children (aged 1 month-<4 years) with focal onset seizures (FOS) using video-electroencephalography (V-EEG).
METHODS


This randomized, placebo-controlled, international study included V-EEG seizure monitoring (48-72 hours) at baseline and over the last 3 days of 14-day (5-day dose escalation; 9-day fixed dose) double-blind pregabalin treatment (7 or 14 mg/kg/d in three divided doses). This was followed by a double-blind 1-week taper. The primary efficacy endpoint was log-transformed seizure rate (log e  [24-hour seizure rate + 1]) for all FOS recorded during the double-blind V-EEG monitoring, evaluated in subjects who took ≥1 dose of study medication, experienced ≥1 baseline seizure(s), and had a treatment phase V-EEG. Safety and tolerability were assessed by adverse events (AEs), clinical laboratory data, physical/neurological examinations, vital signs, and electrocardiograms.
RESULTS


Overall, 175 patients were randomized (mean age = 28.2 months; 59% male, 69% white, 30% Asian) in a 2:1:2 ratio to pregabalin 7 or 14 mg/kg/d (n = 71 or n = 34, respectively), or placebo (n = 70). Pregabalin 14 mg/kg/d (n = 28) resulted in a statistically significant 35% reduction of log e  (24-hour seizure rate + 1) versus placebo (n = 53; P = .022), an effect that was not observed with pregabalin 7 mg/kg/d (n = 59; P = .461). The most frequently reported treatment-emergent AEs for pregabalin 7 mg/kg/d, 14 mg/kg/d, and placebo, respectively, were somnolence (11.3%, 17.6%, and 5.7%) and upper respiratory tract infection (7.0%, 11.8%, and 11.4%). All AEs were mild to moderate in severity.
SIGNIFICANCE


Pregabalin 14 mg/kg/d (but not 7 mg/kg/d) significantly reduced seizure rate in children with FOS, when assessed using V-EEG, compared with placebo. Both pregabalin dosages were generally safe and well tolerated in children 1 month to <4 years of age with FOS. Safety and tolerability were consistent with the known profile of pregabalin in older children with epilepsy.",2020,d (n = 28) resulted in a statistically significant 35% reduction of log e  (24-hour seizure rate + 1) versus placebo (n = 53;,"['older children with epilepsy', 'children (aged 1\xa0month-<4\xa0years) with focal onset seizures (FOS) using video-electroencephalography (V-EEG', '59% male, 69% white, 30% Asian) in a 2:1:2 ratio to pregabalin 7\xa0or 14', 'children 1 month to <4 years of age', 'children 1\xa0month to <4\xa0years of age with FOS', '175 patients were randomized (mean age = 28.2\xa0months']","['pregabalin', 'placebo', 'Pregabalin', 'Pregabalin adjunctive therapy']","['adverse events (AEs), clinical laboratory data, physical/neurological examinations, vital signs, and electrocardiograms', 'log-transformed seizure rate (log e  [24-hour seizure rate\xa0+\xa01]) for all FOS', 'seizure rate', 'focal onset seizures', 'efficacy and safety', 'somnolence', 'Safety and tolerability', 'safe and well tolerated', 'upper respiratory tract infection']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0027853', 'cui_str': 'Neurological Examination'}, {'cui': 'C0518766'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}]",175.0,0.619519,d (n = 28) resulted in a statistically significant 35% reduction of log e  (24-hour seizure rate + 1) versus placebo (n = 53;,"[{'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Mann', 'Affiliation': 'Pfizer Global Research and Development, Groton, Connecticut.'}, {'ForeName': 'Jeremias', 'Initials': 'J', 'LastName': 'Antinew', 'Affiliation': 'Pfizer Global Research and Development, Groton, Connecticut.'}, {'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Knapp', 'Affiliation': 'Pfizer Global Research and Development, Groton, Connecticut.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Almas', 'Affiliation': 'Pfizer, New York, New York.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Pfizer Global Research and Development, Groton, Connecticut.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Scavone', 'Affiliation': 'Pfizer Global Research and Development, Groton, Connecticut.'}, {'ForeName': 'Ruoyong', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Pfizer Global Research and Development, Groton, Connecticut.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Modequillo', 'Affiliation': 'Department of Pediatrics, Perpetual Succour Hospital, Cebu City, Philippines.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Makedonska', 'Affiliation': ""Dnipro City Children's Clinical Hospital #5 of Dnipro City Council, Dnipro, Ukraine.""}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Ortiz', 'Affiliation': ""Child Neuroscience Division, Philippine Children's Medical Center, Quezon City, Philippines.""}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Kyrychenko', 'Affiliation': 'Department of Internal Medicine, Dnipro Medical Institute of Conventional and Alternative Medicine, Dnipro, Ukraine.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Nordli', 'Affiliation': 'Pediatric Neurology, University of Chicago Medicine, Chicago, Illinois.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Farkas', 'Affiliation': 'First Department of Pediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Mark Kristof', 'Initials': 'MK', 'LastName': 'Farkas', 'Affiliation': 'First Department of Pediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Epilepsia,['10.1111/epi.16466']
111,32234534,"Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial.","BACKGROUND


Catheter-based renal denervation has significantly reduced blood pressure in previous studies. Following a positive pilot trial, the SPYRAL HTN-OFF MED (SPYRAL Pivotal) trial was designed to assess the efficacy of renal denervation in the absence of antihypertensive medications.
METHODS


In this international, prospective, single-blinded, sham-controlled trial, done at 44 study sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK, and the USA, hypertensive patients with office systolic blood pressure of 150 mm Hg to less than 180 mm Hg were randomly assigned 1:1 to either a renal denervation or sham procedure. The primary efficacy endpoint was baseline-adjusted change in 24-h systolic blood pressure and the secondary efficacy endpoint was baseline-adjusted change in office systolic blood pressure from baseline to 3 months after the procedure. We used a Bayesian design with an informative prior, so the primary analysis combines evidence from the pilot and Pivotal trials. The primary efficacy and safety analyses were done in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT02439749.
FINDINGS


From June 25, 2015, to Oct 15, 2019, 331 patients were randomly assigned to either renal denervation (n=166) or a sham procedure (n=165). The primary and secondary efficacy endpoints were met, with posterior probability of superiority more than 0·999 for both. The treatment difference between the two groups for 24-h systolic blood pressure was -3·9 mm Hg (Bayesian 95% credible interval -6·2 to -1·6) and for office systolic blood pressure the difference was -6·5 mm Hg (-9·6 to -3·5). No major device-related or procedural-related safety events occurred up to 3 months.
INTERPRETATION


SPYRAL Pivotal showed the superiority of catheter-based renal denervation compared with a sham procedure to safely lower blood pressure in the absence of antihypertensive medications.
FUNDING


Medtronic.",2020,"No major device-related or procedural-related safety events occurred up to 3 months.
","['44 study sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK, and the USA, hypertensive patients with office systolic blood pressure of 150 mm Hg to less than 180 mm', 'From June 25, 2015, to Oct 15, 2019, 331 patients']","['catheter-based renal denervation', 'renal denervation', 'renal denervation or sham procedure']","['No major device-related or procedural-related safety events', 'baseline-adjusted change in 24-h systolic blood pressure and the secondary efficacy endpoint was baseline-adjusted change in office systolic blood pressure', 'blood pressure', '24-h systolic blood pressure', 'office systolic blood pressure']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]","[{'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0011307', 'cui_str': 'Denervation - action'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",331.0,0.54398,"No major device-related or procedural-related safety events occurred up to 3 months.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Saarland University, Homburg (Saar), Germany. Electronic address: michael.boehm@uks.eu.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, GA, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mahfoud', 'Affiliation': 'Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Saarland University, Homburg (Saar), Germany; Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Weber', 'Affiliation': 'SUNY Downstate College of Medicine, Brooklyn, NY, USA.'}, {'ForeName': 'Roland E', 'Initials': 'RE', 'LastName': 'Schmieder', 'Affiliation': 'Universitätsklinikum Erlangen, Erlangen, Germany.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tsioufis', 'Affiliation': 'National and Kapodistrian University of Athens, Hippocratio Hospital, Athens, Greece.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Konstantinidis', 'Affiliation': 'National and Kapodistrian University of Athens, Hippocratio Hospital, Athens, Greece.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': 'Baylor Scott and White Heart and Vascular Hospital, Dallas, TX, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'East', 'Affiliation': 'Baylor Scott and White Heart and Vascular Hospital, Dallas, TX, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Lee', 'Affiliation': 'Stanford Hospital and Clinics, Stanford, CA, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Ma', 'Affiliation': 'Stanford Hospital and Clinics, Stanford, CA, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Ewen', 'Affiliation': 'Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Saarland University, Homburg (Saar), Germany.'}, {'ForeName': 'Debbie L', 'Initials': 'DL', 'LastName': 'Cohen', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wilensky', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Chandan M', 'Initials': 'CM', 'LastName': 'Devireddy', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Lea', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Schmid', 'Affiliation': 'Universitätsklinikum Erlangen, Erlangen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Weil', 'Affiliation': 'Sana Cardiomed Heart Center, LÜbeck, Germany.'}, {'ForeName': 'Tolga', 'Initials': 'T', 'LastName': 'Agdirlioglu', 'Affiliation': 'Sana Cardiomed Heart Center, LÜbeck, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Reedus', 'Affiliation': 'Piedmont Heart Institute, Atlanta, GA, USA.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Jefferson', 'Affiliation': 'TriStar Centennial Medical Center, Nashville, TN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reyes', 'Affiliation': 'TriStar Centennial Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': ""D'Souza"", 'Affiliation': 'The Royal Devon and Exeter Hospital, Exeter, UK.'}, {'ForeName': 'Andrew S P', 'Initials': 'ASP', 'LastName': 'Sharp', 'Affiliation': 'University Hospital of Wales, Cardiff, UK; University of Exeter, Exeter, UK.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Sharif', 'Affiliation': 'Galway University Hospitals and National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fahy', 'Affiliation': 'Medtronic, Santa Rosa, CA, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'DeBruin', 'Affiliation': 'Medtronic, Santa Rosa, CA, USA.'}, {'ForeName': 'Sidney A', 'Initials': 'SA', 'LastName': 'Cohen', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Medtronic, Santa Rosa, CA, USA.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Brar', 'Affiliation': 'Medtronic, Santa Rosa, CA, USA.'}, {'ForeName': 'Raymond R', 'Initials': 'RR', 'LastName': 'Townsend', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30554-7']
112,31552590,Moderate ischemic mitral incompetence: does it worth more ischemic time?,"OBJECTIVES


Ischemic mitral regurgitation (IMR) is a common finding following myocardial infarction or ischemia. Management of moderate IMR is still a hot topic. Adding mitral valve repair (MVr) to coronary artery bypass grafting (CABG) is questionable. The goal of this study was to assess and compare short-term clinical and echocardiographic results of moderate IMR treated by CABG alone versus another group of patients treated by CABG plus MVr.
METHODS


Eighty consecutive patients with ischemic heart disease (IHD) and moderate IMR were divided randomly into two equal groups: group I (40) had only CABG and group II (40) had CABG plus MVr. Patients were evaluated at 1-week, 3-months and 1-year intervals postoperatively.
RESULTS


After 1-year follow-up, our study revealed statistically significant improvement in the grade of mitral regurgitation (MR) in group II than group I. The mean value for effective regurgitant orifice area (EROA) was 0.22 ± 0.13 for group I versus 0.03 ± 0.03 for group II (P = 0.001) and for vena contracta (VC), it was 3.8 ± 2.24 for group I versus 0.4 ± 0.49 for group II (P = 0.000). There was also a significant reduction in the New York Heart Association (NYHA) functional class in both groups.
CONCLUSIONS


MVr can be performed safely and concomitantly with CABG in patients having moderate IMR, and its addition to CABG have significant short-term impact on clinical or echocardiographic outcome of patients.",2020,The mean value for effective regurgitant orifice area (EROA) was 0.22 ± 0.13 for group,"['Eighty consecutive patients with ischemic heart disease (IHD) and moderate IMR', 'Moderate ischemic mitral incompetence']","['CABG alone', 'mitral valve repair (MVr) to coronary artery bypass grafting (CABG', 'CABG', 'CABG plus MVr']","['mean value for effective regurgitant orifice area (EROA', 'New York Heart Association (NYHA) functional class', 'grade of mitral regurgitation (MR']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0026266', 'cui_str': 'Mitral Incompetence'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0396849', 'cui_str': 'Repair of mitral valve (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0026266', 'cui_str': 'Mitral Incompetence'}]",80.0,0.0144609,The mean value for effective regurgitant orifice area (EROA) was 0.22 ± 0.13 for group,"[{'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'El-Hag-Aly', 'Affiliation': 'Cardiothoracic Surgery Department, Faculty of Medicine, Menoufia University, Yassin Abdel Ghaffar Street, Shebin El-Kom, 32511, Menoufia, Egypt.'}, {'ForeName': 'Yasser F', 'Initials': 'YF', 'LastName': 'El Swaf', 'Affiliation': 'Cardiothoracic Surgery Department, Mahalla Cardiac Institute, Mahalla, Gharbia, Egypt.'}, {'ForeName': 'Marwan H', 'Initials': 'MH', 'LastName': 'Elkassas', 'Affiliation': 'Cardiothoracic Surgery Department, Faculty of Medicine, Suez Canal University, Suez, Egypt.'}, {'ForeName': 'Mohamed G', 'Initials': 'MG', 'LastName': 'Hagag', 'Affiliation': 'Cardiothoracic Surgery Department, Faculty of Medicine, Menoufia University, Yassin Abdel Ghaffar Street, Shebin El-Kom, 32511, Menoufia, Egypt. mohamedhagag@med.menofia.edu.eg.'}, {'ForeName': 'Heba Khodary', 'Initials': 'HK', 'LastName': 'Allam', 'Affiliation': 'Public Health and Community Medicine Department, Faculty of Medicine, Menoufia University, Shebin El-Kom, Menoufia, Egypt.'}]",General thoracic and cardiovascular surgery,['10.1007/s11748-019-01212-5']
113,31559589,Effects of high-dose vitamin D supplementation on the occurrence of post-operative atrial fibrillation after coronary artery bypass grafting: randomized controlled trial.,"OBJECTIVE


This study aimed to investigate the preventive effects of a high-dose vitamin D administered preoperatively on the post-operative atrial fibrillation (POAF) occurrence in patients with insufficient or deficient serum vitamin D levels who underwent coronary artery bypass grafting (CABG) surgery.
METHODS


The study was a randomized controlled, blinded and parallel-arm trial conducted on 116 who had vitamin D deficiency or insufficiency during the pre-operative evaluation were included in the study conducted between January 2018 and January 2019. Patients were divided into those who received oral vitamin D (treatment group; n = 58) and those who did not (control group; n = 58) 48 h before CABG surgery. In the treatment group, patients with vitamin D deficiency were administered 300.000 IU vitamin D orally and those with vitamin D insufficiency 150.000 IU 48 h preoperatively. Patients were followed up during hospitalisation process with respect to POAF.
RESULTS


Both groups showed no significant differences with regard to age, gender, body mass index, creatine level, left atrial diameter, pre-operative drug use, calcium level, ejection fraction, diabetes mellitus and hypertension. The ratio of POAF occurrence found in the treatment and control groups were 12.07% and 27.59%, respectively. Vitamin D treatment was found to reduce the risk of POAF development by 0.24 times (p = 0.034).
CONCLUSION


In this study with sufficient sample size, preoperative short-term high-dose vitamin D supplementation was found to be significantly preventive to the occurrence of POAF in patients with vitamin D insufficiency and deficiency who underwent CABG surgery.",2020,"Both groups showed no significant differences with regard to age, gender, body mass index, creatine level, left atrial diameter, pre-operative drug use, calcium level, ejection fraction, diabetes mellitus and hypertension.","['patients with vitamin D insufficiency and deficiency who underwent CABG surgery', 'patients with insufficient or deficient serum vitamin D levels who underwent coronary artery bypass grafting (CABG) surgery', '116 who had vitamin D deficiency or insufficiency during the pre-operative evaluation were included in the study conducted between January 2018 and January 2019', 'post-operative atrial fibrillation after coronary artery bypass grafting', 'patients with vitamin D deficiency']","['high-dose vitamin D supplementation', 'vitamin D supplementation', 'oral vitamin D (treatment group; n\u2009=\u200958) and those who did not (control group; n\u2009=\u200958) 48\xa0h before CABG surgery', 'high-dose vitamin D', 'Vitamin D']","['age, gender, body mass index, creatine level, left atrial diameter, pre-operative drug use, calcium level, ejection fraction, diabetes mellitus and hypertension', 'risk of POAF development', 'ratio of POAF occurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency (finding)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C1293091', 'cui_str': 'Pre-surgery evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement (procedure)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",,0.124069,"Both groups showed no significant differences with regard to age, gender, body mass index, creatine level, left atrial diameter, pre-operative drug use, calcium level, ejection fraction, diabetes mellitus and hypertension.","[{'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Kara', 'Affiliation': 'Department of Cardiovascular Surgery, Giresun Ada Hospital, Giresun, Turkey. hakankarakdc@hotmail.com.'}, {'ForeName': 'Alptekin', 'Initials': 'A', 'LastName': 'Yasim', 'Affiliation': 'Department of Cardiovascular Surgery, Kahramanmaraş Sütçü İmam University, Kahramanmaraş, Turkey.'}]",General thoracic and cardiovascular surgery,['10.1007/s11748-019-01209-0']
114,32320729,Randomized in situ trial on the efficacy of Carbopol in enhancing fluoride / stannous anti-erosive properties.,"OBJECTIVE


To evaluate if the bioadhesive polymer (Carbopol 980) could potentiate the protective effect of sodium fluoride with stannous chloride (FS) solution on the control of enamel erosive wear.
METHODS


Cylindrical bovine enamel specimens were polished and randomly allocated into three groups (n = 60): FS (500 ppm F -  +800 ppm Sn 2+  - positive control), FS + Carbopol (0.1% Carbopol), and ultrapure water (negative control). A randomized double-blind cross-over in situ model with three phases was used. In each phase, volunteers (n = 15) used a palatal appliance containing 4 specimens: two were submitted to an erosion model (2 h of pellicle formation; immersion in 1% citric acid, pH 2.3, for 5 min, 4x/day; 1 h intervals of saliva exposure; and treatment with the test solutions for 1 min, 2x/day). Besides erosion, the other two specimens were also subjected to abrasion (2x/day, 15 s) with active electric toothbrush, before the treatment with the solutions. After 5 days, enamel surface loss (μm) was evaluated by profilometry. Data were analyzed by two-way RM-ANOVA and Tukey tests (5%).
RESULTS


There were significant differences for both challenge and treatment factors. Erosion/abrasion challenge resulted in significantly higher enamel loss than erosion only (p < 0.05). The surface loss values for the erosion/remineralization model were (means ± SL): C = 14.7 ± 5.8b; FS = 9.0 ± 7.5ab; FS + Carbopol = 5.9 ± 3.8a; and for erosion/abrasion: C = 26.6 ± 10.1c; FS = 15.0 ± 8.8b; FS + Carbopol = 12.3 ± 7.9ab.
CONCLUSION


The association of Carbopol to the FS solution significantly protected the enamel against erosive wear, but it was not significantly superior to FS only.
CLINICAL SIGNIFICANCE


Under highly erosive and abrasive conditions, rinsing with solutions containing sodium fluoride plus stannous chloride, associated or not with the Carbopol polymer, is an effective approach to control enamel erosive wear.",2020,Erosion/abrasion challenge resulted in significantly higher enamel loss than erosion only (p < 0.05).,"['Cylindrical bovine enamel specimens', 'enamel erosive wear']","['sodium fluoride plus stannous chloride', 'FS (500\u2009ppm F- +800\u2009ppm', 'sodium fluoride with stannous chloride (FS) solution', 'Carbopol', 'bioadhesive polymer (Carbopol 980', 'palatal appliance containing 4 specimens: two were submitted to an erosion model (2\u2009h of pellicle formation; immersion in 1% citric acid, pH 2.3, for 5\u2009min, 4x/day; 1\u2009h intervals of saliva exposure']",['enamel loss'],"[{'cui': 'C0205114', 'cui_str': 'Cylindrical'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}]","[{'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0075160', 'cui_str': 'stannous chloride'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0108434', 'cui_str': 'Carbopol'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C1542809', 'cui_str': 'Carbopol 980'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C1257926', 'cui_str': 'Salivary Acquired Pellicle'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}]",,0.0322465,Erosion/abrasion challenge resulted in significantly higher enamel loss than erosion only (p < 0.05).,"[{'ForeName': 'Daniele Mara da Silva', 'Initials': 'DMDS', 'LastName': 'Ávila', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: daniele-mara@uol.com.br.'}, {'ForeName': 'Rayssa Ferreira', 'Initials': 'RF', 'LastName': 'Zanatta', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil; Department of Restorative Dentistry, Dental School, University of Taubaté, Taubaté, Brazil. Electronic address: zanatta.rayssa@gmail.com.'}, {'ForeName': 'Tais', 'Initials': 'T', 'LastName': 'Scaramucci', 'Affiliation': 'Department of Restorative Dentistry, São Paulo University-USP, São Paulo, Brazil. Electronic address: tais.sca@usp.br.'}, {'ForeName': 'Idalina Vieira', 'Initials': 'IV', 'LastName': 'Aoki', 'Affiliation': 'Department of Chemical Engineering, Polytechnic School, São Paulo University-USP, São Paulo, Brazil. Electronic address: idavaoki@usp.br.'}, {'ForeName': 'Carlos Rocha Gomes', 'Initials': 'CRG', 'LastName': 'Torres', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: carlos.rg.torres@unesp.br.'}, {'ForeName': 'Alessandra Bühler', 'Initials': 'AB', 'LastName': 'Borges', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: alessandra.buhler@unesp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103347']
115,32319039,Efficacy and Safety of Galcanezumab for the Preventive Treatment of Migraine: A Narrative Review.,"Migraine is a debilitating neurologic disease. People who experience migraine can have substantial disability, impaired functioning and a decreased quality of life (QoL). Expert recommendations suggest that people with frequent migraine attacks or severe impairment related to attacks may benefit from preventive treatment. Despite these recommendations and the existence of evidence-based guidelines for the use of preventive medication, many people who are candidates for preventive therapies do not receive them. Thus, there is still a substantial unmet need for preventive migraine treatment. Calcitonin gene-related peptide (CGRP) has a demonstrated role in the pathophysiology of migraine. Galcanezumab-gnlm (galcanezumab) is a humanized monoclonal antibody that binds to the CGRP ligand and prevents binding to its receptor. It is administered as a once-monthly subcutaneous injection. The aim of this review is to present a comprehensive overview of the existing short- and long-term efficacy and safety data for galcanezumab in patients with migraine. Data from the phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2 and REGAIN studies show that galcanezumab treatment for 3 or 6 months results in overall reduction in mean monthly migraine headache days in patients with episodic (EVOLVE-1 and EVOLVE-2) and chronic (REGAIN) migraine. Greater proportions of patients with episodic migraine receiving galcanezumab versus placebo demonstrated a ≥ 50%, ≥ 75% and 100% response to therapy and reported a lower level of disability and an improvement in functioning and QoL. Similarly, when compared with placebo, greater proportions of patients with chronic migraine treated with galcanezumab demonstrated a ≥ 50% and ≥ 75% response and reported improved functioning. A 12-month open-label study demonstrated the continued efficacy of galcanezumab for up to 12 months. In all studies galcanezumab was well tolerated. In conclusion, data from pivotal studies show that galcanezumab may fulfill an unmet need in the treatment of patients with migraine who require preventive therapy.",2020,"Greater proportions of patients with episodic migraine receiving galcanezumab versus placebo demonstrated a ≥ 50%, ≥ 75% and 100% response to therapy and reported a lower level of disability and an improvement in functioning and QoL. Similarly, when compared with placebo, greater proportions of patients with chronic migraine treated with galcanezumab demonstrated a ≥ 50% and ≥ 75% response and reported improved functioning.","['patients with migraine', 'patients with episodic (EVOLVE-1 and EVOLVE-2) and chronic (REGAIN) migraine', 'patients with migraine who require preventive therapy', 'Migraine']","['Calcitonin gene-related peptide (CGRP', 'Migraine', 'Galcanezumab-gnlm (galcanezumab', 'galcanezumab', 'placebo', 'galcanezumab versus placebo', 'Galcanezumab']","['Efficacy and Safety', 'quality of life (QoL', 'level of disability', 'tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C4731561', 'cui_str': 'galcanezumab-gnlm'}, {'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.0581009,"Greater proportions of patients with episodic migraine receiving galcanezumab versus placebo demonstrated a ≥ 50%, ≥ 75% and 100% response to therapy and reported a lower level of disability and an improvement in functioning and QoL. Similarly, when compared with placebo, greater proportions of patients with chronic migraine treated with galcanezumab demonstrated a ≥ 50% and ≥ 75% response and reported improved functioning.","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Martin', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Karen Hamrick', 'Initials': 'KH', 'LastName': 'Samaan', 'Affiliation': 'Lilly USA, LLC, Indianapolis, IN, USA. karen.samaan@lilly.com.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'Aurora', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pearlman', 'Affiliation': 'Lilly USA, LLC, Indianapolis, IN, USA.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pallay', 'Affiliation': 'Department of Family Medicine, Mercer University School of Medicine, Savannah, GA, USA.'}]",Advances in therapy,['10.1007/s12325-020-01319-9']
116,32315553,Exergaming as an Additional Tool in Rehabilitation of Young Patients with Rheumatoid Arthritis: A Pilot Randomized Controlled Trial.,"Objective:  To assess the effectiveness of home videogame-based exercise (exergaming) as an additional rehabilitative tool in young patients with rheumatoid arthritis (RA).  Materials and Methods:  After a baseline (T0) evaluation, 40 RA inpatients (18-35 years of age) underwent both a 4-week-lasting traditional rehabilitation program and a training by Nintendo ®  Wii-Fit™ videogame system. At discharge (T1), subjects were randomly assigned (1:1) to two groups: Group A (experimental group), including subjects who continued Wii-Fit training at home for additional 8 weeks, and Group B (control group), including subjects maintaining their habitual activity during the 8-week follow-up (T2). Measures of disease activity, quality of life, and fatigue were evaluated at each time point.  Results:  From T0 to T1, a significant improvement in most evaluated outcomes was reported in both study groups. At T2 assessment, only Group A patients experienced a significant improvement of quality of life and fatigue, with a 13.4% reduction in Global Health (GH) values, only a slight increase (4.2%) in Health Assessment Questionnaire (HAQ) score, and a 19.1% Functional Assessment of Chronic Illness Therapy (FACIT) improvement as compared with T1. In contrast, Group B patients reported a 65.8% increase in GH values, a 33% increase in HAQ score, and a 53.4% reduction in FACIT values from T1 to T2. The extended videogame-based home training was an independent predictor of Δ%GH ( β  = 0.851;  P  < 0.001), Δ%HAQ ( β  = 0.542;  P  < 0.001), and Δ%FACIT ( β  = -0.505;  P  < 0.001).  Conclusions:  Home exergaming may be an effective additional rehabilitative tool in RA, since it allows to maintain the benefits of traditional multidisciplinary rehabilitation.",2020,"The extended videogame-based home training was an independent predictor of Δ%GH ( β  = 0.851;  P  < 0.001), Δ%HAQ ( β  = 0.542;  P  < 0.001), and Δ%FACIT ( β  ","['Young Patients with Rheumatoid Arthritis', '40 RA inpatients (18-35 years of age', 'young patients with rheumatoid arthritis (RA']","['4-week-lasting traditional rehabilitation program and a training by Nintendo ®  Wii-Fit™ videogame system', 'home videogame-based exercise (exergaming', 'subjects who continued Wii-Fit training at home for additional 8 weeks, and Group B (control group']","['Health Assessment Questionnaire (HAQ) score', 'disease activity, quality of life, and fatigue', 'HAQ score', 'FACIT values', 'GH values', 'Functional Assessment of Chronic Illness Therapy (FACIT) improvement', 'quality of life and fatigue', 'Global Health (GH) values']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2960025', 'cui_str': 'Health assessment questionnaire score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0102923', 'cui_str': 'ametantrone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}]",40.0,0.0329088,"The extended videogame-based home training was an independent predictor of Δ%GH ( β  = 0.851;  P  < 0.001), Δ%HAQ ( β  = 0.542;  P  < 0.001), and Δ%FACIT ( β  ","[{'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Ambrosino', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.'}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'Iannuzzi', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Formisano', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.'}, {'ForeName': 'Giorgio Alfredo', 'Initials': 'GA', 'LastName': 'Spedicato', 'Affiliation': 'Unipol Group, Bologna, Italy.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': ""D'Abrosca"", 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Di Gioia', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.'}, {'ForeName': 'Matteo Nicola Dario', 'Initials': 'MND', 'LastName': 'Di Minno', 'Affiliation': 'Department of Translational Medical Sciences, ""Federico II"" University, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Pappone', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.'}]",Games for health journal,['10.1089/g4h.2019.0167']
117,32297945,Effect of Treatment Expectation on Placebo Response and Analgesic Efficacy: A Secondary Aim in a Randomized Clinical Trial.,,2020,,[],[],['Placebo Response and Analgesic Efficacy'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.420829,,"[{'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Sanders', 'Affiliation': 'Division of Pediatric and Public Health, Adams School of Dentistry, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Slade', 'Affiliation': 'Division of Pediatric and Public Health, Adams School of Dentistry, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Fillingim', 'Affiliation': 'Department of Community Dentistry and Behavioral Science, University of Florida, Gainesville.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ohrbach', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University at Buffalo, State University of New York, Buffalo.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Arbes', 'Affiliation': 'Rho Inc, Durham, North Carolina.'}, {'ForeName': 'Inna E', 'Initials': 'IE', 'LastName': 'Tchivileva', 'Affiliation': 'Division of Oral and Craniofacial Health Sciences, Adams School of Dentistry, University of North Carolina at Chapel Hill.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.2907']
118,32297946,Effect of Smartphone-Enabled Health Monitoring Devices vs Regular Follow-up on Blood Pressure Control Among Patients After Myocardial Infarction: A Randomized Clinical Trial.,"Importance


Smart technology via smartphone-compatible devices might improve blood pressure (BP) regulation in patients after myocardial infarction.
Objectives


To investigate whether smart technology in clinical practice can improve BP regulation and to evaluate the feasibility of such an intervention.
Design, Setting, and Participants


This study was an investigator-initiated, single-center, nonblinded, feasibility, randomized clinical trial conducted at the Department of Cardiology of the Leiden University Medical Center between May 2016 and December 2018. Two hundred patients, who were admitted with either ST-segment elevation myocardial infarction or non-ST-segment acute coronary syndrome, were randomized in a 1:1 fashion between follow-up groups using smart technology and regular care. Statistical analysis was performed from January 2019 to March 2019.
Interventions


For patients randomized to regular care, 4 physical outpatient clinic visits were scheduled in the year following the initial event. In the intervention group, patients were given 4 smartphone-compatible devices (weight scale, BP monitor, rhythm monitor, and step counter). In addition, 2 in-person outpatient clinic visits were replaced by electronic visits.
Main Outcomes and Measures


The primary outcome was BP control. Secondary outcomes, as a parameter of feasibility, included patient satisfaction (general questionnaire and smart technology-specific questionnaire), measurement adherence, all-cause mortality, and hospitalizations for nonfatal adverse cardiac events.
Results


In total, 200 patients (median age, 59.7 years [interquartile range, 52.9-65.6 years]; 156 men [78%]) were included, of whom 100 were randomized to the intervention group and 100 to the control group. After 1 year, 79% of patients in the intervention group had controlled BP vs 76% of patients in the control group (P = .64). General satisfaction with care was the same between groups (mean [SD] scores, 82.6 [14.1] vs 82.0 [15.1]; P = .88). The all-cause mortality rate was 2% in both groups (P > .99). A total of 20 hospitalizations for nonfatal adverse cardiac events occurred (8 in the intervention group and 12 in the control group). Of all patients, 32% sent in measurements each week, with 63% sending data for more than 80% of the weeks they participated in the trial. In the intervention group only, 90.3% of patients were satisfied with the smart technology intervention.
Conclusions and Relevance


These findings suggest that smart technology yields similar percentages of patients with regulated BP compared with the standard of care. Such an intervention is feasible in clinical practice and is accepted by patients. More research is mandatory to improve patient selection of such an intervention.
Trial Registration


ClinicalTrials.gov Identifier: NCT02976376.",2020,"After 1 year, 79% of patients in the intervention group had controlled BP vs 76% of patients in the control group (P = .64).","['Patients', '200 patients (median age, 59.7 years [interquartile range, 52.9-65.6 years]; 156 men [78', 'patients after myocardial infarction', 'Two hundred patients, who were admitted with either ST-segment elevation myocardial infarction or non-ST-segment acute coronary syndrome', 'After Myocardial Infarction', 'Department of Cardiology of the Leiden University Medical Center between May 2016 and December 2018']","['Smartphone-Enabled Health Monitoring Devices vs Regular Follow-up', 'smart technology and regular care']","['BP regulation', 'blood pressure (BP) regulation', 'controlled BP', 'BP control', 'mortality rate', 'nonfatal adverse cardiac events', 'General satisfaction with care', 'parameter of feasibility, included patient satisfaction (general questionnaire and smart technology-specific questionnaire), measurement adherence, all-cause mortality, and hospitalizations for nonfatal adverse cardiac events', 'Blood Pressure Control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0429029', 'cui_str': 'ST segment'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",200.0,0.0937239,"After 1 year, 79% of patients in the intervention group had controlled BP vs 76% of patients in the control group (P = .64).","[{'ForeName': 'Roderick W', 'Initials': 'RW', 'LastName': 'Treskes', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Loes A M', 'Initials': 'LAM', 'LastName': 'van Winden', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'van Keulen', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Enno T', 'Initials': 'ET', 'LastName': 'van der Velde', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Saskia L M A', 'Initials': 'SLMA', 'LastName': 'Beeres', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Douwe E', 'Initials': 'DE', 'LastName': 'Atsma', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Martin Jan', 'Initials': 'MJ', 'LastName': 'Schalij', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.2165']
119,32317591,Potential for Lung Recruitment and Ventilation-Perfusion Mismatch in Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019.,"OBJECTIVES


Severe cases of coronavirus disease 2019 develop the acute respiratory distress syndrome, requiring admission to the ICU. This study aimed to describe specific pathophysiological characteristics of acute respiratory distress syndrome from coronavirus disease 2019.
DESIGN


Prospective crossover physiologic study.
SETTING


ICU of a university-affiliated hospital from northern Italy dedicated to care of patients with confirmed diagnosis of coronavirus disease 2019.
PATIENTS


Ten intubated patients with acute respiratory distress syndrome and confirmed diagnosis of coronavirus disease 2019.
INTERVENTIONS


We performed a two-step positive end-expiratory pressure trial with change of 10 cm H2O in random order.
MEASUREMENTS AND MAIN RESULTS


At each positive end-expiratory pressure level, we assessed arterial blood gases, respiratory mechanics, ventilation inhomogeneity, and potential for lung recruitment by electrical impedance tomography. Potential for lung recruitment was assessed by the recently described recruitment to inflation ratio. In a subgroup of seven paralyzed patients, we also measured ventilation-perfusion mismatch at lower positive end-expiratory pressure by electrical impedance tomography. At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure. Oxygenation and ventilation inhomogeneity improved but arterial CO2 increased despite unchanged respiratory rate and tidal volume. The recruitment to inflation ratio presented median value higher than previously reported in acute respiratory distress syndrome patients but with large variability (median, 0.79 [0.53-1.08]; range, 0.16-1.40). The FIO2 needed to obtain viable oxygenation at lower positive end-expiratory pressure was significantly correlated with the recruitment to inflation ratio (r = 0.603; p = 0.05). The ventilation-perfusion mismatch was elevated (median, 34% [32-45%] of lung units) and, in six out of seven patients, ventilated nonperfused units represented a much larger proportion than perfused nonventilated ones.
CONCLUSIONS


In patients with acute respiratory distress syndrome from coronavirus disease 2019, potential for lung recruitment presents large variability, while elevated dead space fraction may be a specific pathophysiological trait. These findings may guide selection of personalized mechanical ventilation settings.",2020,"At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure.","['Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019', 'patients with acute respiratory distress syndrome', 'acute respiratory distress syndrome from coronavirus disease 2019', 'ICU of a university-affiliated hospital from northern Italy dedicated to care of patients with confirmed diagnosis of coronavirus disease 2019', 'Ten intubated patients with acute respiratory distress syndrome and confirmed diagnosis of coronavirus disease 2019', 'Severe cases of coronavirus disease 2019 develop the acute respiratory distress syndrome, requiring admission to the ICU']",['Lung Recruitment and Ventilation-Perfusion Mismatch'],"['arterial blood gases, respiratory mechanics, ventilation inhomogeneity, and potential for lung recruitment by electrical impedance tomography', 'respiratory rate and tidal volume', 'ventilation-perfusion mismatch']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2721740', 'cui_str': 'Ventilation perfusion mismatch'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C2721740', 'cui_str': 'Ventilation perfusion mismatch'}]",10.0,0.127794,"At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure.","[{'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Mauri', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Spinelli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Scotti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Colussi', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Basile', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Crotti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Tubiolo', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Tagliabue', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zanella', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Grasselli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}]",Critical care medicine,['10.1097/CCM.0000000000004386']
120,32286882,HDL-apoA-I kinetics in response to 16 wk of exercise training in men with nonalcoholic fatty liver disease.,"Nonalcoholic fatty liver disease (NAFLD) is characterized by low-circulating concentration of high-density lipoprotein cholesterol (HDL-C) and raised triacylglycerol (TAG). Exercise reduces hepatic fat content, improves insulin resistance and increases clearance of very-low-density lipoprotein-1 (VLDL 1 ). However, the effect of exercise on TAG and HDL-C metabolism is unknown. We randomized male participants to 16 wk of supervised, moderate-intensity aerobic exercise ( n  = 15), or conventional lifestyle advice ( n  = 12). Apolipoprotein A-I (apoA-I) and VLDL-TAG and apolipoprotein B (apoB) kinetics were investigated using stable isotopes (1-[ 13 C]-leucine and 1,1,2,3,3- 2 H 5  glycerol) pre- and postintervention. Participants underwent MRI/spectroscopy to assess changes in visceral fat. Results are means ± SD. At baseline, there were no differences between exercise and control groups for age (52.4 ± 7.5 vs. 52.8 ± 10.3 yr), body mass index (BMI: 31.6 ± 3.2 vs. 31.7 ± 3.6 kg/m 2 ), and waist circumference (109.3 ± 7.5 vs. 110.0 ± 13.6 cm). Percentage of liver fat was 23.8 (interquartile range 9.8-32.5%). Exercise reduced body weight (101.3 ± 10.2 to 97.9 ± 12.2 kg;  P  < 0.001) and hepatic fat content [from 19.6%, interquartile range (IQR) 14.6-36.1% to 8.9% (4.4-17.8%);  P  = 0.001] and increased the fraction HDL-C concentration (measured following ultracentrifugation) and apoA-I pool size with no change in the control group. However, plasma and VLDL 1 -TAG concentrations and HDL-apoA-I fractional catabolic rate (FCR) and production rate (PR) did not change significantly with exercise. Both at baseline (all participants) and after exercise there was an inverse correlation between apoA-I pool size and VLDL-TAG and -apoB pool size. The modest effect of exercise on HDL metabolism may be explained by the lack of effect on plasma and VLDL 1 -TAG.",2020,"Exercise reduced body weight (101.3±10.2 to 97.9±12.2 kg; P<0.001) and hepatic fat content (from 19.6%, IQR 14.6-36.1% to 8.9% (4.4-17.8%); P=0.001) and increased the fraction HDL-C concentration (measured following ultracentrifugation) and apoA-I pool size with no change in the control group.","['male participants to 16 weeks of', 'men with non-alcoholic fatty liver disease (NAFLD']","['MRI/spectroscopy', 'exercise training', 'supervised, moderate-intensity aerobic exercise (n=15) or conventional lifestyle advice']","['Exercise reduced body weight', 'visceral fat', 'hepatic fat content', 'BMI', 'Percentage liver fat', 'waist circumference', 'hepatic fat content, improves insulin resistance and increases clearance of very-low density lipoprotein-1 (VLDL1', 'Apolipoprotein A-I (apoA-I) and VLDL-TAG and apolipoprotein B (apoB) kinetics', 'fraction HDL-C concentration', 'plasma and VLDL1 TAG concentrations and HDL-apoA-I fractional catabolic rate (FCR) and production rate (PR']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0078207', 'cui_str': 'Very low density lipoprotein triglyceride'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",,0.147255,"Exercise reduced body weight (101.3±10.2 to 97.9±12.2 kg; P<0.001) and hepatic fat content (from 19.6%, IQR 14.6-36.1% to 8.9% (4.4-17.8%); P=0.001) and increased the fraction HDL-C concentration (measured following ultracentrifugation) and apoA-I pool size with no change in the control group.","[{'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Whyte', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, United Kingdom.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Shojaee-Moradie', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, United Kingdom.'}, {'ForeName': 'Sharaf E', 'Initials': 'SE', 'LastName': 'Sharaf', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, United Kingdom.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Cuthbertson', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Graham J', 'Initials': 'GJ', 'LastName': 'Kemp', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Barrett', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, United Kingdom.'}, {'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Jackson', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, United Kingdom.'}, {'ForeName': 'Roselle A', 'Initials': 'RA', 'LastName': 'Herring', 'Affiliation': 'Centre for Diabetes, Endocrinology, and Research, Royal Surrey County Hospital, Guildford, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wright', 'Affiliation': 'Centre for Diabetes, Endocrinology, and Research, Royal Surrey County Hospital, Guildford, United Kingdom.'}, {'ForeName': 'E Louise', 'Initials': 'EL', 'LastName': 'Thomas', 'Affiliation': 'Research Centre for Optimal Health, School of Life Sciences, University of Westminster, London, United Kingdom.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Bell', 'Affiliation': 'Research Centre for Optimal Health, School of Life Sciences, University of Westminster, London, United Kingdom.'}, {'ForeName': 'A Margot', 'Initials': 'AM', 'LastName': 'Umpleby', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, United Kingdom.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00019.2020']
121,31641203,A secondary analysis of testosterone and electrically evoked resistance training versus testosterone only (TEREX-SCI) on untrained muscles after spinal cord injury: a pilot randomized clinical trial.,"STUDY DESIGN


Secondary analysis of a clinical trial.
OBJECTIVES


To perform a secondary analysis on the effects of neuromuscular electrical stimulation resistance training (RT) combined with testosterone replacement therapy (TRT) compared with TRT on the untrained muscles after spinal cord injury (SCI).
SETTING


Medical research center.
METHODS


Twenty-two men with chronic motor complete SCI were randomized into TRT + RT group (n = 11) or TRT group (n = 11). Both groups received 16 weeks of TRT (2-6 mg/day) via testosterone patches. The TRT + RT group received twice weekly progressive RT of the knee extensor muscles using electrical stimulation and ankle weights. Magnetic resonance images were captured to measure cross-sectional areas (CSAs) of trunk, glutei, and leg muscles.
RESULTS


Total and absolute gluteus maximus m. (14%, P = 0.003 and 16%, P = 0.001), gluteus medius m. (10%; P = 0.008 and 14%; P = 0.02), and total glutei m. (8%, P = 0.01 and 11%, P = 0.005) CSAs increased overtime for the TRT + RT group. Mean between-group differences of 2.86 (95% CI: 0.30, 5.4), 1.89 (95% CI: 0.23, 3.58) and 5.27 (95% CI: 0.90, 9.69) cm 2  were noted for absolute gluteus maximus, total gluteus medius and total glutei CSAs, respectively (P < 0.05). Trunk muscle CSAs showed a trend towards an interaction between groups.
CONCLUSIONS


RT combined with low-dose TRT results in significant hypertrophy compared with TRT only on the adjacent untrained glutei muscles. Trunk muscles may require direct stimulation to evoke hypertrophy. These exploratory findings may be of clinical relevance in the reduction of incidence and severity of pelvic pressure injuries.",2020,"RESULTS


Total and absolute gluteus maximus m. (14%, P = ","['untrained muscles after spinal cord injury (SCI', 'untrained muscles after spinal cord injury', 'Twenty-two men with chronic motor complete SCI']","['testosterone and electrically evoked resistance training versus testosterone only (TEREX-SCI', 'testosterone patches', 'TRT\u2009+\u2009RT', 'TRT', 'neuromuscular electrical stimulation resistance training (RT) combined with testosterone replacement therapy (TRT', 'CSAs']","['total glutei m', 'absolute gluteus maximus, total gluteus medius and total glutei CSAs']","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",22.0,0.145549,"RESULTS


Total and absolute gluteus maximus m. (14%, P = ","[{'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Gorgey', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA. ashraf.gorgey@va.gov.'}, {'ForeName': 'Sally M', 'Initials': 'SM', 'LastName': 'Abilmona', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sima', 'Affiliation': 'Department of Biostatistics, School of Medicine Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Refka E', 'Initials': 'RE', 'LastName': 'Khalil', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Rehan', 'Initials': 'R', 'LastName': 'Khan', 'Affiliation': 'Radiology Service, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Adler', 'Affiliation': 'Endocrinology Section Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}]",Spinal cord,['10.1038/s41393-019-0364-3']
122,32310283,Effects of Wait Times on Treatment Adherence and Clinical Outcomes in Patients With Severe Sleep-Disordered Breathing: A Secondary Analysis of a Noninferiority Randomized Clinical Trial.,"Importance


Sleep-disordered breathing (SDB) is common and associated with substantial adverse health consequences. Long wait times for SDB care are commonly reported; however, it is unclear whether wait times for care are associated with clinical outcomes.
Objective


To evaluate the association of wait times for care with clinical outcomes for patients with severe SDB.
Design, Setting, and Participants


This study is a secondary analysis of a randomized clinical noninferiority trial comparing management by alternative care practitioners (ACPs) with traditional sleep physician-led care between October 2014 and May 2017. The study took place at Foothills Medical Centre Sleep Centre, a tertiary care multidisciplinary sleep clinic at the University of Calgary. Patients with severe SDB (defined as a respiratory event index ≥30 events per hour during home sleep apnea testing, mean nocturnal oxygen saturation ≤85%, or suspected sleep hypoventilation syndrome) were recruited for the study. Patients were excluded if they were suspected of having a concomitant sleep disorder other than SDB or had previously been treated with positive airway pressure (PAP) therapy for SDB. Data were analyzed from October 2017 to January 2020.
Main Outcomes and Measures


Outcomes were assessed 3 months after treatment initiation with adherence to PAP therapy as the primary outcome. Secondary outcomes included Epworth Sleepiness Scale score, health-related quality of life, and patient satisfaction measured using the Visit-Specific Satisfaction Instrument-9. Multiple regression models were used to assess the associations between wait times and each of the outcomes. t tests were used to compare wait times for patients who were adherent to PAP therapy (≥4 hours per night for 70% of nights) with those for nonadherent patients.
Results


One hundred fifty-six patients (112 [71.8%] men; mean [SD] age, 56 [12] years) were included in the analysis. The mean time from referral to initial visit was 88 days (95% CI, 79 to 96 days), and the mean time to treatment was 123 days (95% CI, 112 to 133 days). Shorter wait time to treatment initiation was associated with adherence to PAP therapy (odds ratio, 0.99; 95% CI, 0.98 to 0.99; P = .04), greater improvement in Epworth Sleepiness Scale score (mean coefficient, -9.37; 95% CI, -18.51 to -0.24; P = .04), and higher Visit-Specific Satisfaction Instrument-9 score (mean coefficient, -0.024; 95% CI, -0.047 to -0.0015; P = .04) at 3 months. Compared with nonadherent patients, those who were adherent to treatment waited a mean of 15 fewer days (95% CI, 12 to 19 days) for initial assessment (P = .07) and 30 fewer days (95% CI, 23 to 35 days) for treatment initiation (P = .008).
Conclusions and Relevance


Earlier initiation of treatment for severe SDB was associated with better PAP adherence and greater improvements in daytime sleepiness and patient satisfaction. These findings suggest that system interventions to improve timely access may modify patient behavior and improve clinical outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT02191085.",2020,"Conclusions and Relevance


Earlier initiation of treatment for severe SDB was associated with better PAP adherence and greater improvements in daytime sleepiness and patient satisfaction.","['Patients were excluded if they were suspected of having a concomitant sleep disorder other than SDB or had previously been treated with positive airway pressure (PAP) therapy for SDB', 'The study took place at Foothills Medical Centre Sleep Centre, a tertiary care multidisciplinary sleep clinic at the University of Calgary', 'Patients with severe SDB (defined as a respiratory event index ≥30 events per hour during home sleep apnea testing, mean nocturnal oxygen saturation ≤85%, or suspected sleep hypoventilation syndrome', 'patients with severe SDB', 'Patients With Severe Sleep-Disordered Breathing', 'Data were analyzed from October 2017 to January 2020', 'One hundred fifty-six patients (112 [71.8%] men; mean [SD] age, 56 [12] years) were included in the analysis', 'alternative care practitioners (ACPs) with traditional sleep physician-led care between October 2014 and May 2017']",['Importance\n\n\nSleep-disordered breathing (SDB'],"['mean time from referral to initial visit', 'Treatment Adherence and Clinical Outcomes', 'PAP adherence', 'Epworth Sleepiness Scale score, health-related quality of life, and patient satisfaction measured using the Visit-Specific Satisfaction Instrument-9', 'Epworth Sleepiness Scale score', 'higher Visit-Specific Satisfaction Instrument-9 score', 'daytime sleepiness and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0205394', 'cui_str': 'Other'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C2732337', 'cui_str': 'Sleep hypoventilation'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4706348', 'cui_str': 'ESS (Epworth Sleepiness Scale) score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}]",,0.181914,"Conclusions and Relevance


Earlier initiation of treatment for severe SDB was associated with better PAP adherence and greater improvements in daytime sleepiness and patient satisfaction.","[{'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'Thornton', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Willis H', 'Initials': 'WH', 'LastName': 'Tsai', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Santana', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Erika D', 'Initials': 'ED', 'LastName': 'Penz', 'Affiliation': 'College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'W Ward', 'Initials': 'WW', 'LastName': 'Flemons', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Fraser', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Hanly', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Sachin R', 'Initials': 'SR', 'LastName': 'Pendharkar', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.3088']
123,32267568,Efficacy of repeat forward-view examination of the right-sided colon during colonoscopy: A prospective randomized controlled trial.,"BACKGROUND AND AIM


Generally, colonoscopy is less effective for detecting colorectal adenomas in the right-sided colon compared with the distal colon. Repeat forward-view (RF) examination of the right-sided colon has been suggested to increase the adenoma detection rate (ADR). However, studies investigating the efficacy of RF examination are lacking. Thus, the aim of this study was to determine whether RF examination in the right-sided colon enhances right-sided ADR.
METHODS


We performed a prospective, randomized controlled trial, including asymptomatic subjects who underwent screening colonoscopy. Subjects were randomized to the RF group, in which the right-sided colon was examined twice in the forward view, or to the standard forward-view (SF) group, in which the right-sided colon was examined once in the forward view. The primary outcome was the right-sided ADR on RF examination of the right-sided colon.
RESULTS


A total of 640 subjects completed the study protocol (RF group, n = 320; SF group, n = 320). The right-sided ADR in the RF group was significantly higher than that in the SF group (17.5% vs 11.9%, respectively; P = 0.044). In the RF group, an additional 31 adenomas were found, resulting in an increased detection rate of adenomas of 38.3% compared with the first forward view. The ADR of the whole colon was similar between the groups.
CONCLUSIONS


In our prospective randomized controlled trial, RF examination of the right-sided colon, which can be easily performed in clinical practice, was associated with an increased rate of detection of right-sided ADR.",2020,"The ADR of the whole colon was similar between the groups.
","['640 subjects completed the study protocol (RF group, n = 320; SF group, n = 320', 'asymptomatic subjects who underwent screening colonoscopy']",['repeat forward-view examination of the right-sided colon during colonoscopy'],"['detection rate of adenomas', 'adenoma detection rate (ADR', 'right-sided ADR on RF examination of the right-sided colon', 'RF examination']","[{'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C1882982', 'cui_str': 'Screening colonoscopy'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}]",640.0,0.0611496,"The ADR of the whole colon was similar between the groups.
","[{'ForeName': 'Su Young', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Divison of Gastroenterology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea.'}, {'ForeName': 'Sang Jin', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Divison of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Jun-Won', 'Initials': 'JW', 'LastName': 'Chung', 'Affiliation': 'Divison of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Kwang An', 'Initials': 'KA', 'LastName': 'Kwon', 'Affiliation': 'Divison of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Kyoung Oh', 'Initials': 'KO', 'LastName': 'Kim', 'Affiliation': 'Divison of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Yoon Jae', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Divison of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Jung Ho', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Divison of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Dong Kyun', 'Initials': 'DK', 'LastName': 'Park', 'Affiliation': 'Divison of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, South Korea.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15064']
124,32290829,Comparison of facilitated tucking and oral dextrose in reducing the pain of heel stick in preterm infants: a randomized clinical trial.,"BACKGROUND


With the increase in hospitalization of premature infants in emergency departments and the painful procedure in these sectors, appropriate methods of pain relief are required. This study aimed to compare the effect of oral dextrose and facilitated tucking in the reduction of pain during heel sticks in premature infants and assess their effectiveness and feasibility for use in emergency settings.
METHODS


This study was a randomized controlled clinical trial with cross-over design. Sixty infants were recruited from a Neonatal Intensive Care Unit (NICU) at Valiasr hospital in Tehran, Iran from March 2015 to September 2016. They were randomly allocated into three groups (no pain relief method, oral dextrose and facilitated tucking). Six blood samples were collected by heel stick for each infant. Oral dextrose and facilitated tucking were compared with the routine method of blood sampling and pain was measured two times for each method. The pain scores was measured by the Premature Infant Pain Profile (PIPP). Repeated Measure ANOVA, ANOVA and Scheffe post-hoc test were used with SPSS 16.
RESULTS


The pain score's increase during heel stick was significantly lower after using oral dextrose (3.58 ± 0.34) and facilitated tucking (5.58 ± 0.53) in comparison to the routine method (8.91 ± 0.18) of blood sampling (P < 0.001, η 2  = 0.971). Oral dextrose was more effective than facilitated tucking (P < 0.001, Cohen's d = 4.49). The emergency nurses rated oral dextrose as easier (t = 2.20, df = 118, p = 0.02, Cohen's d = 0.39) and more applicable method (t = 2.99, df = 118, p = 0.003, Cohen's d = 0.54) for the emergency department.
CONCLUSIONS


Facilitated tucking is an effective method of pain reduction which can be used in the absence of oral dextrose, in a situation in which it is contraindicated or in combination with oral dextrose. Based on the increase of infant's admission in emergency department future studies are needed to identify the best method of pain reduction for procedures in this setting.
TRIAL REGISTRATION


Current Controlled Trials IRCT201408029568N9, 2014-09-08.",2020,"Oral dextrose was more effective than facilitated tucking (P < 0.001, Cohen's d = 4.49).","['2014-09-08', 'Sixty infants were recruited from a Neonatal Intensive Care Unit (NICU) at Valiasr hospital in Tehran, Iran from March 2015 to September 2016', 'preterm infants', 'premature infants']","['oral dextrose and facilitated tucking', 'Oral dextrose', 'facilitated tucking and oral dextrose']","[""pain score's increase during heel stick"", 'pain of heel stick', 'Premature Infant Pain Profile (PIPP', 'pain scores', 'blood sampling and pain']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0419343', 'cui_str': 'Heel stick'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}]",60.0,0.0772821,"Oral dextrose was more effective than facilitated tucking (P < 0.001, Cohen's d = 4.49).","[{'ForeName': 'Athareh', 'Initials': 'A', 'LastName': 'Ranjbar', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Bernstein', 'Affiliation': 'Department of Psychology, School of Human and Community Development, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Mamak', 'Initials': 'M', 'LastName': 'Shariat', 'Affiliation': 'Materno-Fetal, Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Ranjbar', 'Affiliation': 'Mental Health Research Center, Psychosocial Health Research Institute, Iran University of Medical Science, Tehran, Iran. ranjbar.h@iums.ac.ir.'}]",BMC pediatrics,['10.1186/s12887-020-2020-7']
125,31961967,Six-dimensional quantitative DCE MR Multitasking of the entire abdomen: Method and application to pancreatic ductal adenocarcinoma.,"PURPOSE


To develop a quantitative DCE MRI technique enabling entire-abdomen coverage, free-breathing acquisition, 1-second temporal resolution, and T 1  -based quantification of contrast agent concentration and kinetic modeling for the characterization of pancreatic ductal adenocarcinoma (PDAC).
METHODS


Segmented FLASH readouts following saturation-recovery preparation with randomized 3D Cartesian undersampling was used for incoherent data acquisition. MR Multitasking was used to reconstruct 6-dimensional images with 3 spatial dimensions, 1 T 1  recovery dimension for dynamic T 1  quantification, 1 respiratory dimension to resolve respiratory motion, and 1 DCE time dimension to capture the contrast kinetics. Sixteen healthy subjects and 14 patients with pathologically confirmed PDAC were recruited for the in vivo studies, and kinetic parameters v p  , K trans  , v e  , and K ep  were evaluated for each subject. Intersession repeatability of Multitasking DCE was assessed in 8 repeat healthy subjects. One-way unbalanced analysis of variance was performed between control and patient groups.
RESULTS


In vivo studies demonstrated that v p  , K trans  , and K ep  of PDAC were significantly lower compared with nontumoral regions in the patient group (P = .002, .003, .004, respectively) and normal pancreas in the control group (P = .011, <.001, <.001, respectively), while v e  was significantly higher than nontumoral regions (P < .001) and healthy pancreas (P < .001). The kinetic parameters showed good in vivo repeatability (interclass correlation coefficient: v p  , 0.95; K trans  , 0.98; v e  , 0.96; K ep  , 0.99).
CONCLUSION


The proposed Multitasking DCE is promising for the quantification of vascular properties of PDAC. Quantitative DCE parameters were repeatable in vivo and showed significant differences between normal pancreas and both tumor and nontumoral regions in patients with PDAC.",2020,while v e  was significantly higher than nontumoral regions (P < .001) and healthy pancreas (P < .001).,"['8 repeat healthy subjects', 'patients with PDAC', 'Sixteen healthy subjects and 14 patients with pathologically confirmed PDAC', 'entire abdomen', 'pancreatic ductal adenocarcinoma']",['Multitasking DCE'],"['healthy pancreas', 'K trans  , and K ep  of PDAC', 'vivo repeatability']","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}]",[],[],16.0,0.0351948,while v e  was significantly higher than nontumoral regions (P < .001) and healthy pancreas (P < .001).,"[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Biomedical Imaging Research Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Gaddam', 'Affiliation': 'Division of Digestive and Liver Diseases, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Biomedical Imaging Research Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Yibin', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Biomedical Imaging Research Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Zhaoyang', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'Biomedical Imaging Research Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Wensha', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Clinical Radiation Oncology, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Tuli', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lo', 'Affiliation': 'Division of Digestive and Liver Diseases, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hendifar', 'Affiliation': 'Department of Gastrointestinal Malignancies, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pandol', 'Affiliation': 'Division of Digestive and Liver Diseases, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Christodoulou', 'Affiliation': 'Biomedical Imaging Research Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Debiao', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Biomedical Imaging Research Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}]",Magnetic resonance in medicine,['10.1002/mrm.28167']
126,30940760,AMBIsome Therapy Induction OptimisatioN (AMBITION): High dose AmBisome for cryptococcal meningitis induction therapy in sub-Saharan Africa: economic evaluation protocol for a randomised controlled trial-based equivalence study.,"INTRODUCTION


Cryptococcal meningitis is responsible for around 15% of all HIV-related deaths globally. Conventional treatment courses with amphotericin B require prolonged hospitalisation and are associated with multiple toxicities and poor outcomes. A phase II study has shown that a single high dose of liposomal amphotericin may be comparable to standard treatment. We propose a phase III clinical endpoint trial comparing single, high-dose liposomal amphotericin with the WHO recommended first-line treatment at six sites across five counties. An economic analysis is essential to support wide-scale implementation.
METHODS AND ANALYSIS


Country-specific economic evaluation tools will be developed across the five country settings. Details of patient and household out-of-pocket expenses and any catastrophic healthcare expenditure incurred will be collected via interviews from trial patients. Health service patient costs and related household expenditure in both arms will be compared over the trial period in a probabilistic approach, using Monte Carlo bootstrapping methods. Costing information and number of life-years survived will be used as the input to a decision-analytic model to assess the cost-effectiveness of a single, high-dose liposomal amphotericin to the standard treatment. In addition, these results will be compared with a historical cohort from another clinical trial.
ETHICS AND DISSEMINATION


The AMBIsome Therapy Induction OptimisatioN (AMBITION) trial has been evaluated and approved by the London School of Hygiene and Tropical Medicine, University of Botswana, Malawi National Health Sciences, University of Cape Town, Mulago Hospital and Zimbabwe Medical Research Council research ethics committees. All participants will provide written informed consent or if lacking capacity will have consent provided by a proxy. The findings of this economic analysis, part of the AMBITION trial, will be disseminated through peer-reviewed publications and at international and country-level policy meetings.
TRIAL REGISTRATION


ISRCTN 7250 9687; Pre-results.",2019,"Health service patient costs and related household expenditure in both arms will be compared over the trial period in a probabilistic approach, using Monte Carlo bootstrapping methods.",[],"['liposomal amphotericin', 'amphotericin B']",['multiple toxicities'],[],"[{'cui': 'C0085795', 'cui_str': 'Amphotericin'}, {'cui': 'C0002679', 'cui_str': 'Amphotericin B'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.193288,"Health service patient costs and related household expenditure in both arms will be compared over the trial period in a probabilistic approach, using Monte Carlo bootstrapping methods.","[{'ForeName': 'Ponego Lloyd', 'Initials': 'PL', 'LastName': 'Ponatshego', 'Affiliation': 'Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'David Stephen', 'Initials': 'DS', 'LastName': 'Lawrence', 'Affiliation': 'Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Nabila', 'Initials': 'N', 'LastName': 'Youssouf', 'Affiliation': 'Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Sile F', 'Initials': 'SF', 'LastName': 'Molloy', 'Affiliation': ""Research Centre for Infection and Immunity, St. George's University of London, London, UK.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Alufandika', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Centre, Blantyre, Malawi.'}, {'ForeName': 'Funeka', 'Initials': 'F', 'LastName': 'Bango', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Chimwemwe', 'Initials': 'C', 'LastName': 'Chawinga', 'Affiliation': 'Lilongwe Medical Relief Trust (UNC Project), Lilongwe, Malawi.'}, {'ForeName': 'Eltas', 'Initials': 'E', 'LastName': 'Dziwani', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Centre, Blantyre, Malawi.'}, {'ForeName': 'Ebbie', 'Initials': 'E', 'LastName': 'Gondwe', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Centre, Blantyre, Malawi.'}, {'ForeName': 'Admire', 'Initials': 'A', 'LastName': 'Hlupeni', 'Affiliation': 'Department of Medicine, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'Lilongwe Medical Relief Trust (UNC Project), Lilongwe, Malawi.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Kanyama', 'Affiliation': 'Lilongwe Medical Relief Trust (UNC Project), Lilongwe, Malawi.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Meya', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Mosepele', 'Initials': 'M', 'LastName': 'Mosepele', 'Affiliation': 'Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Muthoga', 'Affiliation': 'Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Conrad K', 'Initials': 'CK', 'LastName': 'Muzoora', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Mwandumba', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Centre, Blantyre, Malawi.'}, {'ForeName': 'Chiratidzo E', 'Initials': 'CE', 'LastName': 'Ndhlovu', 'Affiliation': 'Department of Medicine, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'Department of Medicine, University of Minnesota, Minnesota, USA.'}, {'ForeName': 'Sumaya', 'Initials': 'S', 'LastName': 'Sayed', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Shepherd', 'Initials': 'S', 'LastName': 'Shamu', 'Affiliation': 'Department of Medicine, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Katlego', 'Initials': 'K', 'LastName': 'Tsholo', 'Affiliation': 'Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Tugume', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Darlisha', 'Initials': 'D', 'LastName': 'Williams', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Hendramoorthy', 'Initials': 'H', 'LastName': 'Maheswaran', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Centre, Blantyre, Malawi.'}, {'ForeName': 'Tinevimbo', 'Initials': 'T', 'LastName': 'Shiri', 'Affiliation': 'Department of Clinical Sciences and International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Timothée', 'Initials': 'T', 'LastName': 'Boyer-Chammard', 'Affiliation': 'Molecular Mycology Unit and National Reference Centre for Invasive Mycoses, Institut Pasteur, Paris, France.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Loyse', 'Affiliation': ""Research Centre for Infection and Immunity, St. George's University of London, London, UK.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Sciences and International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Sciences and International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Lortholary', 'Affiliation': 'Molecular Mycology Unit and National Reference Centre for Invasive Mycoses, Institut Pasteur, Paris, France.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Lalloo', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Centre, Blantyre, Malawi.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Meintjes', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Shabbar', 'Initials': 'S', 'LastName': 'Jaffar', 'Affiliation': 'Department of Clinical Sciences and International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Harrison', 'Affiliation': ""Research Centre for Infection and Immunity, St. George's University of London, London, UK.""}, {'ForeName': 'Joseph N', 'Initials': 'JN', 'LastName': 'Jarvis', 'Affiliation': 'Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Louis Wilhelmus', 'Initials': 'LW', 'LastName': 'Niessen', 'Affiliation': 'Department of Clinical Sciences and International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.'}]",BMJ open,['10.1136/bmjopen-2018-026288']
127,32092343,Radiation Dose Escalation or Longer Androgen Suppression to Prevent Distant Progression in Men With Locally Advanced Prostate Cancer: 10-Year Data From the TROG 03.04 RADAR Trial.,"PURPOSE


To clarify the relative effects of duration of androgen suppression (AS) and radiation dose escalation (RDE) on distant progression (DP) in men with locally advanced prostate cancer.
METHODS AND MATERIALS


Participants with locally advanced prostate cancer in the TROG 03.04 RADAR trial were randomized to 6 or 18 months AS ± 18 months zoledronic acid (Z). The trial incorporated a RDE program by stratification at randomization and dosing options were 66, 70, or 74 Gy external beam radiation therapy (EBRT), or 46 Gy EBRT plus high-dose-rate brachytherapy boost (HDRB). The primary endpoint for this study was distant progression (DP). Secondary endpoints included local progression, bone progression, prostate cancer-specific mortality and all-cause mortality. Effect estimates for AS duration and RDE were derived using Fine and Gray competing risk models adjusting for use of Z, age, tumor stage, Gleason grade group, prostate-specific antigen, and treatment center. Cumulative incidence at 10 years was estimated for each RDE group.
RESULTS


A total of 1051 out of 1071 randomized subjects were eligible for inclusion in this analysis. Compared with 6 months AS, 18 months AS significantly reduced DP independently of radiation dose (subhazard ratio 0.70; 95% confidence interval [CI], 0.56-0.87; P = .002). No statistically significant interaction between effect of AS duration and RT dose was observed (Wald test P = .76). In subgroup analyses, DP was significantly reduced by the longer duration of AS in the 70 Gy and HDRB groups but not in the 66 Gy and 74 Gy. Compared with 70 Gy, HDRB significantly reduced DP (subhazard ratio 0.68 [95% CI, 0.57-0.80]; P < .0001) independently of AS duration. At 10 years, adjusted cumulative incidences were 26.1% (95% CI, 18.9%-33.2%), 26.7% (22.9%-30.6%), 24.9% (20.0%-29.8%) and 19.7% (15.5%-23.8%) for DPs in the respective radiation dose groups.
CONCLUSIONS


Compared with 6 months AS, 18 months AS reduced DP independently of radiation dose. Men treated with HDRB gained a significant benefit from a longer duration of AS. Evidence of improved oncologic outcomes for HDRB compared with dose-escalated EBRT needs to be confirmed in a randomized trial.",2020,"Compared with 70 Gy, HDRB significantly reduced DP (subhazard ratio 0.68","['men with locally advanced prostate cancer', 'Participants with locally advanced prostate cancer in the TROG 03.04 RADAR trial', 'Men With Locally Advanced Prostate Cancer', 'A total of 1051 out of 1071 randomized subjects were eligible for inclusion in this analysis']","['Radiation Dose Escalation or Longer Androgen Suppression', '74 Gy external beam radiation therapy (EBRT), or 46 Gy EBRT plus high-dose-rate brachytherapy boost (HDRB', 'zoledronic acid (Z', 'HDRB', 'androgen suppression (AS) and radiation dose escalation (RDE']","['distant progression (DP', 'local progression, bone progression, prostate cancer-specific mortality and all-cause mortality', 'longer duration of AS', 'Cumulative incidence', 'adjusted cumulative incidences']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0034513', 'cui_str': 'Radar'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0450319', 'cui_str': '1051'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0454270', 'cui_str': 'High dose rate brachytherapy (observable entity)'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}]","[{'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",1071.0,0.16583,"Compared with 70 Gy, HDRB significantly reduced DP (subhazard ratio 0.68","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Joseph', 'Affiliation': 'Department of Medicine and Surgery, University of Western Australia, Western Australia, Australia; GenesisCare, Joondalup, Western Australia, Australia; 5D Clinics, Claremont, Western Australia, Australia.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Denham', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia. Electronic address: Jim.Denham@newcastle.edu.au.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Steigler', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Lamb', 'Affiliation': 'Wellington School of Medicine and Health Sciences, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Nigel A', 'Initials': 'NA', 'LastName': 'Spry', 'Affiliation': 'GenesisCare, Joondalup, Western Australia, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stanley', 'Affiliation': 'Hollywood Specialist Centre, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Shannon', 'Affiliation': 'The Prostate Clinic, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Duchesne', 'Affiliation': 'Peter MacCallum Cancer Centre and University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Atkinson', 'Affiliation': 'St Georges Cancer Care Centre, Christchurch, New Zealand.'}, {'ForeName': 'John H L', 'Initials': 'JHL', 'LastName': 'Matthews', 'Affiliation': 'Cancer and Blood Services, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Turner', 'Affiliation': 'Crown Princess Mary Cancer Centre, Westmead Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Kenny', 'Affiliation': ""Royal Brisbane and Women's Hospital, Brisbane, Australia; School of Medicine, University of Queensland, Queensland, Australia.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Christie', 'Affiliation': 'Genesiscare, Tugun, Queensland, Australia.'}, {'ForeName': 'Keen-Hun', 'Initials': 'KH', 'LastName': 'Tai', 'Affiliation': 'Peter MacCallum Cancer Centre and University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Nirdosh Kumar', 'Initials': 'NK', 'LastName': 'Gogna', 'Affiliation': 'Mater Radiation Oncology Centre, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kearvell', 'Affiliation': ""GenesisCare, St Andrew's Hospital, Adelaide, South Australia, Australia.""}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Murray', 'Affiliation': 'Wellington School of Medicine and Health Sciences, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Ebert', 'Affiliation': '5D Clinics, Claremont, Western Australia, Australia; Department of Physics, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Haworth', 'Affiliation': 'School of Physics, University of Sydney, Sydney, New South Wales.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Delahunt', 'Affiliation': 'Wellington School of Medicine and Health Sciences, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia; Hunter Medical Research Institute, Newcastle, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Attia', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia; Hunter Medical Research Institute, Newcastle, New South Wales, Australia.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2019.11.415']
128,31770005,"""GiochiAMO,"" a Gaming Intervention to Prevent Smoking and Alcohol Habits Among Children: A Single-Arm Field Trial.","Objectives:  To evaluate the efficacy of the ""GiochiAMO"" prevention program on modifying children's knowledge and belief regarding the use and abuse of alcohol and tobacco smoking.  Materials and Methods:  ""GiochiAMO"" is a multicomponent single-arm field trial based on card and board games to teach and enhance knowledge about risk factors related to smoking and alcohol consumption. A structured questionnaire was administered before and after the intervention to assess any change in knowledge.  Results:  A total of 167 students between 9 and 11 years of age took part in the intervention. Data concerning knowledge about cigarette smoking showed a statistically significant improvement ( P  = 0.008) with an increase of the mean scores from 5.93 (standard deviation [SD] = 2.05) to 7.90 (SD = 2.03). The scores related to the life skills of the intervention performed in the fourth grade classes demonstrated statistically significant improvements ( P  = 0.027). The scores related to the knowledge about alcohol consumption highlighted a statistically significant improvement ( P  < 0.001), with mean scores that rose from 7.44 (SD = 1.99) to 9.41 (SD = 1.94). The scores related to the life skills of the intervention performed in the fifth grade classes demonstrated improvements, although they were not statistically significant ( P  = 0.770).  Conclusions:  ""GiochiAMO"" demonstrated significantly improved knowledge about the risk and consequences of cigarette smoking and alcohol consumption on health. Longer follow-up studies, including a larger sample size, will be needed.",2020,"The scores related to the knowledge about alcohol consumption highlighted a statistically significant improvement ( P  < 0.001), with mean scores that rose from 7.44 (SD = 1.99) to 9.41 (SD = 1.94).","['167 students between 9 and 11 years of age took part in the intervention', 'Children']","['GiochiAMO"" prevention program', 'GiochiAMO', 'GiochiAMO,"" a Gaming Intervention']",['Smoking and Alcohol Habits'],"[{'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",,0.0186416,"The scores related to the knowledge about alcohol consumption highlighted a statistically significant improvement ( P  < 0.001), with mean scores that rose from 7.44 (SD = 1.99) to 9.41 (SD = 1.94).","[{'ForeName': 'Rosario Andrea', 'Initials': 'RA', 'LastName': 'Cocchiara', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sestili', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Di Bella', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Insa', 'Initials': 'I', 'LastName': 'Backhaus', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Sinopoli', 'Affiliation': 'Local Health Unit 1, Department of Prevention, Roma, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': ""D'Egidio"", 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Lia', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Rosella', 'Initials': 'R', 'LastName': 'Saulle', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Mannocci', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'La Torre', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.'}]",Games for health journal,['10.1089/g4h.2019.0125']
129,31770007,The Effects of Different Exergame Intensity Training on Walking Speed in Older Women.,"Objective:  It is not known if the intensity in which exergames are performed can change gait parameters at different walking speeds. This study was designed to determine if a training program based on exergame exercises performed at different intensities (moderate vs. vigorous) influences walking speed and gait parameters in older adult women.  Methods:  After applying the inclusion criteria, 20 participants (69.5 ± 5.4 years) were randomized into two groups: moderate (11-13 perceived exertion) and vigorous (14-16 perceived exertion). Walking speed and gait parameters at self-selected walking speed (SSWS) and maximal walking speed (MWS) were evaluated before and after 3 months of exergame training. The walking speed and gait parameters were measured with an instrumented walkway. The walking speed reserve (WSR) was calculated as a difference and ratio.  Results:  There was pre-to-post effect of walking speed at self-selected walking pace (pre = 112.1 ± 16.4 cm.s -1 ; post = 124.8 ± 16.4 cm.s -1 ), in WSR calculated as ratio (pre = 1.35 ± 0.08; post = 1.28 ± 0.09), in a number of gait parameters at SSWS (step length, stride length, stride velocity, step time, stride time, swing time, stance time, single support, double support, gait cycle time, and cadence) and at MWS (step time, stride time, swing time, single support, double support, gait cycle time, and cadence).  Conclusion:  Irrespective of the exercise intensity, exergame training improved walking speed only at a self-selected walking pace and some gait parameters at self-selected and MWS in older women.",2020,"Conclusion:  Irrespective of the exercise intensity, exergame training improved walking speed only at a self-selected walking pace and some gait parameters at self-selected and MWS in older women.","['older women', 'older adult women', '20 participants (69.5\u2009±\u20095.4 years', 'Older Women']","['Exergame Intensity Training', 'exercise intensity, exergame training improved walking speed only at a self-selected walking pace and some gait parameters at self-selected and MWS']","['walking speed reserve (WSR', 'Walking speed and gait parameters at self-selected walking speed (SSWS) and maximal walking speed (MWS', 'walking speed and gait parameters', 'walking speed at self-selected walking pace', 'number of gait parameters at SSWS (step length, stride length, stride velocity, step time, stride time, swing time, stance time, single support, double support, gait cycle time, and cadence) and at MWS (step time, stride time, swing time, single support, double support, gait cycle time, and cadence']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0427126', 'cui_str': 'Step length (observable entity)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}]",20.0,0.0288713,"Conclusion:  Irrespective of the exercise intensity, exergame training improved walking speed only at a self-selected walking pace and some gait parameters at self-selected and MWS in older women.","[{'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Pitta', 'Affiliation': 'Department of Physical Education, Federal University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Gleber', 'Initials': 'G', 'LastName': 'Pereira', 'Affiliation': 'Department of Physical Education, Federal University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Jerusa Petróvna Resende', 'Initials': 'JPR', 'LastName': 'Lara', 'Affiliation': 'Department of Physical Education, Federal University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Joice Katiane Mendes', 'Initials': 'JKM', 'LastName': 'Beck', 'Affiliation': 'Department of Physical Education, Federal University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Wolf', 'Affiliation': 'Department of Physical Education, Federal University of Parana, Curitiba, Brazil.'}, {'ForeName': 'John Jairo Villarejo', 'Initials': 'JJV', 'LastName': 'Mayor', 'Affiliation': 'Department of Physical Education, Federal University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Natália Boneti', 'Initials': 'NB', 'LastName': 'Moreira', 'Affiliation': 'Physiotherapy Department, Federal University of Paraná (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Andre Luiz Felix', 'Initials': 'ALF', 'LastName': 'Rodacki', 'Affiliation': 'Department of Physical Education, Federal University of Parana, Curitiba, Brazil.'}]",Games for health journal,['10.1089/g4h.2019.0109']
130,32052592,Brachio-basilic upper arm transposition fistulas vs. prosthetic brachio-axillary vascular access grafts-Which one is preferred for hemodialysis?,"INTRODUCTION


There is still controversy on the use of brachio-basilic upper arm transposition fistula (BBAVF) and prosthetic brachio-axillary vascular access grafts (BAPTFE) in patients with no suitable cephalic veins for creating an autogenous brachio-cephalic fistula.
METHODS


In a randomized controlled clinical trial, 60 hemodialysis patients who were not a suitable candidate for BCAVF were randomly assigned into two groups: BBAVF and BAPTFE. The patients were clinically followed up to 1 year and the patency rate and access-related complications were compared between the two groups.
FINDINGS


Access failure rate in the BBAVF and BAPTFE groups was 30.0% and 36.6%, respectively. The primary patency time was 232.73 ± 113.36 and 261.53 ± 147.37 days, respectively (P = 0.40). Thrombosis formation and infection were the two main causes for access failure, yet indicating no significant difference between the two groups (P > 0.05).
DISCUSSION


BBAVF and BAPTFE have comparable clinical outcomes in short-term follow-up. Therefore, BAPTFE can be used as an alternative vascular access for hemodialysis in patients who are not a suitable candidate for BBAVF.",2020,"The patients were clinically followed up to 1 year and the patency rate and access-related complications were compared between the two groups.
","['60 hemodialysis patients who were not a suitable candidate for BCAVF', 'patients with no suitable cephalic veins for creating an autogenous brachio-cephalic fistula', 'hemodialysis in patients who are not a suitable candidate for BBAVF']","['BBAVF and BAPTFE', 'Brachio-basilic upper arm transposition fistulas vs. prosthetic brachio-axillary vascular access grafts', 'brachio-basilic upper arm transposition fistula (BBAVF) and prosthetic brachio-axillary vascular access grafts (BAPTFE']","['Thrombosis formation and infection', 'patency rate and access-related complications', 'primary patency time']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0226802', 'cui_str': 'Structure of cephalic vein'}, {'cui': 'C0443145', 'cui_str': 'Autogenous (qualifier value)'}, {'cui': 'C0205096', 'cui_str': 'Cephalic (qualifier value)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}]","[{'cui': 'C0446516', 'cui_str': 'Brachiums'}, {'cui': 'C0040759', 'cui_str': 'Transposition (morphologic abnormality)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",60.0,0.0389302,"The patients were clinically followed up to 1 year and the patency rate and access-related complications were compared between the two groups.
","[{'ForeName': 'Pouya', 'Initials': 'P', 'LastName': 'Tayebi', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Rouhani Hospital, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Gholamhossein', 'Initials': 'G', 'LastName': 'Kazemzadeh', 'Affiliation': 'Vascular and Endovascular Surgery Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Hadi Saeed', 'Initials': 'MHS', 'LastName': 'Modaghegh', 'Affiliation': 'Vascular and Endovascular Surgery Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Mahdi', 'Initials': 'MM', 'LastName': 'Kamyar', 'Affiliation': 'Vascular and Endovascular Surgery Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Ravari', 'Affiliation': 'Vascular and Endovascular Surgery Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12817']
131,30912314,Performance of a novel reusable pediatric pulse oximeter probe.,"OBJECTIVE


To assess the performance of reusable pulse oximeter probe and microprocessor box combinations, of varying price-points, in the context of a low-income pediatric setting.
METHODS


A prospective, randomized cross-over study comparing time to biologically plausible oxygen saturation (SpO 2  ) between: (1) Lifebox LB-01 probe with Masimo Rad-87 box (L + M) and (2) a weight-appropriate reusable Masimo probe with Masimo Rad-87 box (M + M). A post hoc secondary analysis comparison with historical usability testing data with the Lifebox LB-01 probe and Lifebox V1.5 box (L + L) was also conducted. Participants, children aged 0 to 35 months, were recruited from pediatric wards and outpatient clinics in the central region of Malawi. The primary outcome was time taken to achieve a biologically plausible SpO  2  measurement, compared using t tests for equivalence.
RESULTS


We recruited 572 children. Plausible SpO 2  measurements were obtained in less than 1 minute, 71%, 70%, and 63% for the M + M, L + M, and L + L combinations, respectively. A similar pattern was seen for less than 2 minutes, however, this effect disappeared at less than 5 minutes with 96%, 96%, and 95% plausible measurements. Using a ±10 second threshold for equivalence, we found L + M and M + M to be equivalent, but were under-powered to assess equivalence for L + L.
CONCLUSIONS


The novel reusable pediatric Lifebox probe can achieve a quality SpO 2  measurement within a pragmatic time range of weight-appropriate Masimo equivalent probes. Further research, which considers the cost of the devices, is needed to assess the added value of sophisticated motion tolerance software.",2019,"A similar pattern was seen for less than 2 minutes, however, this effect disappeared at less than 5 minutes with 96%, 96%, and 95% plausible measurements.","['572 children', 'Participants, children aged 0 to 35 months, were recruited from pediatric wards and outpatient clinics in the central region of Malawi']","['Lifebox LB-01 probe and Lifebox V1.5 box (L\u2009+\u2009L', 'biologically plausible oxygen saturation (SpO 2  ) between: (1) Lifebox LB-01 probe with Masimo Rad-87 box (L\u2009+\u2009M) and (2) a weight-appropriate reusable Masimo probe with Masimo Rad-87 box (M\u2009+\u2009M', 'novel reusable pediatric pulse oximeter probe']",['time taken to achieve a biologically plausible SpO  2  measurement'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0454907', 'cui_str': 'Central region (geographic location)'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}]","[{'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0182408', 'cui_str': 'Pulse oximeter probe (physical object)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",572.0,0.0535354,"A similar pattern was seen for less than 2 minutes, however, this effect disappeared at less than 5 minutes with 96%, 96%, and 95% plausible measurements.","[{'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'King', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Tisungane', 'Initials': 'T', 'LastName': 'Mvalo', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Sessions', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Wilson', 'Affiliation': 'Lifebox Foundation, London, UK.'}, {'ForeName': 'Isabeau', 'Initials': 'I', 'LastName': 'Walker', 'Affiliation': 'Lifebox Foundation, London, UK.'}, {'ForeName': 'Beatiwel', 'Initials': 'B', 'LastName': 'Zadutsa', 'Affiliation': 'Parent and Child Health Initiative, Lilongwe, Malawi.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Makwenda', 'Affiliation': 'Parent and Child Health Initiative, Lilongwe, Malawi.'}, {'ForeName': 'Tambosi', 'Initials': 'T', 'LastName': 'Phiri', 'Affiliation': 'Parent and Child Health Initiative, Lilongwe, Malawi.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Boyd', 'Affiliation': ""King's Sierra Leona Partnership, Freetown, Sierra Leone.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Bernstein', 'Affiliation': 'Physio Monitor Llt, San Ramon, California.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'McCollum', 'Affiliation': 'Department of Pediatrics, Eudowood Division of Pediatric Respiratory Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland.'}]",Pediatric pulmonology,['10.1002/ppul.24295']
132,32144874,The influence of HIV-related stigma on PrEP disclosure and adherence among adolescent girls and young women in HPTN 082: a qualitative study.,"INTRODUCTION


Stigma and disclosure concerns have been key barriers to oral pre-exposure prophylaxis (PrEP) adherence for African adolescent girls and young women (AGYW) in efficacy trials. We aimed to understand the impact of these factors among African AGYW in an open-label PrEP study.
METHODS


HPTN 082 was an open-label PrEP study among AGYW (ages 16 to 24) in Harare, Zimbabwe, and Cape Town and Johannesburg, South Africa from 2016 to 2018. Women starting PrEP were randomized to standard adherence support (counselling, two-way SMS, monthly adherence clubs) or standard support plus drug-level feedback. Serial in-depth interviews were conducted among 67 AGYW after 13-week and 26-week study visits to explore experiences of stigma, disclosure and PrEP adherence. We analysed data by coding transcripts and memo-writing and diagramming to summarize themes.
RESULTS


AGYW described stigma related to sexual activity (e.g. ""people say I'm a prostitute"") and being perceived to be living with HIV because of taking antiretrovirals (e.g. ""my husband's friends say I'm HIV infected""). Participants who anticipated stigma were reluctant to disclose PrEP use and reported adherence challenges. Disclosure also resulted in stigmatizing experiences. Across all sites, negative descriptions of stigma and disclosure challenges were more common in the first interview. In the second interview, participants often described disclosure as an ""empowering"" way to combat community-level PrEP stigma; many said that they proactively discussed PrEP in their communities (e.g. became a ""community PrEP ambassador""), which improved their ability to take PrEP and encourage others to use PrEP. These empowering disclosure experiences were facilitated by ongoing HPTN 082 study activities (e.g. counselling sessions, adherence clubs) in which they could discuss PrEP-related stigma, disclosure and PrEP adherence issues.
CONCLUSIONS


Stigma and disclosure challenges were initial concerns for African AGYW newly initiating PrEP but many were empowered to disclose PrEP use over their first six months of PrEP use, which helped them cope with stigma and feel more able to take PrEP regularly. PrEP programmes can foster disclosure through community and clinic-based discussion, adherence clubs and activities normalizing sexual behaviour and PrEP use, which can reduce stigma and improve PrEP adherence and thus effectiveness.",2020,"INTRODUCTION


Stigma and disclosure concerns have been key barriers to oral pre-exposure prophylaxis (PrEP) adherence for African adolescent girls and young women (AGYW) in efficacy trials.","['adolescent girls and young women in HPTN 082', 'HPTN 082 was an open-label PrEP study among AGYW (ages 16 to 24) in Harare, Zimbabwe, and Cape Town and Johannesburg, South Africa from 2016 to 2018', 'Women starting PrEP', 'African adolescent girls and young women']","['oral pre-exposure prophylaxis (PrEP) adherence', 'standard adherence support (counselling, two-way SMS, monthly adherence clubs) or standard support plus drug-level feedback', 'HIV-related stigma']","['stigma, disclosure and PrEP adherence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C1272689', 'cui_str': 'Started'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0428212', 'cui_str': 'Finding of drug level (finding)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}]",,0.0345496,"INTRODUCTION


Stigma and disclosure concerns have been key barriers to oral pre-exposure prophylaxis (PrEP) adherence for African adolescent girls and young women (AGYW) in efficacy trials.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Velloza', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Nomhle', 'Initials': 'N', 'LastName': 'Khoza', 'Affiliation': 'Wits Reproductive Health & HIV Institute (Wits RHI), Johannesburg, South Africa.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Scorgie', 'Affiliation': 'Wits Reproductive Health & HIV Institute (Wits RHI), Johannesburg, South Africa.'}, {'ForeName': 'Miria', 'Initials': 'M', 'LastName': 'Chitukuta', 'Affiliation': 'Clinical Trials Research Centre, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Prisca', 'Initials': 'P', 'LastName': 'Mutero', 'Affiliation': 'Clinical Trials Research Centre, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Kudzai', 'Initials': 'K', 'LastName': 'Mutiti', 'Affiliation': 'Clinical Trials Research Centre, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Nomvuyo', 'Initials': 'N', 'LastName': 'Mangxilana', 'Affiliation': 'Desmond Tutu HIV Foundation, Cape Town, South Africa.'}, {'ForeName': 'Lumka', 'Initials': 'L', 'LastName': 'Nobula', 'Affiliation': 'Desmond Tutu HIV Foundation, Cape Town, South Africa.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Bulterys', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Millicent', 'Initials': 'M', 'LastName': 'Atujuna', 'Affiliation': 'Desmond Tutu HIV Foundation, Cape Town, South Africa.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Hosek', 'Affiliation': 'Stroger H. Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Heffron', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Faculty of Health Sciences, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Nyaradzo', 'Initials': 'N', 'LastName': 'Mgodi', 'Affiliation': 'Clinical Trials Research Centre, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Chirenje', 'Affiliation': 'Clinical Trials Research Centre, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Celum', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'Delany-Moretlwe', 'Affiliation': 'Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25463']
133,32069162,Sutureless Appendectomy by Using Harmonic Scalpel: Is It Possible?,"Introduction:  Laparoscopic appendectomy is a commonly performed procedure. The base of appendix is secured by various techniques (suture, LigaSure, endoloop, or hamlock clip). Harmonic scalpel (HS) may be used to seal the base of the appendix. The study was conducted to assess the efficacy of HS in laparoscopic appendectomy for sealing the base of the appendix.  Materials and Methods:  The patients were divided into two groups: group 1 in which base was secured by endoloop and group 2 in which base of the appendix was sealed by HS in a stepwise manner. We made a record of patients' age and gender, and operative time. The patients were followed for a period of 3 months from the time of discharge.  Results:  During the study period of 4.5 years, 102 patients were in group 1 and 108 patients in group 2. Both groups were age and gender matched. Mean operating time for group 1 was 43.34 ± 6.7 minutes and that for group 2 was 28.46 ± 7.19 minutes ( P  < .0001). Complications included postoperative ileus (group 1 = 8, group 2 = 10) and surgical site infection (group 1 = 4, group 2 = 4,  P  > .05).  Conclusion:  It appears that use of HS for laparoscopic appendectomy is feasible and safe. Its results appear to be comparable with other methods of laparoscopic appendectomy. Complications are minimal. Further studies at other centers may substantiate our efforts.",2020,"Complications included postoperative ileus (group 1 = 8, group 2 = 10) and surgical site infection (group 1 = 4, group 2 = 4,  P  > .05).  ",['102 patients were in group 1 and 108 patients in group 2'],"['Harmonic scalpel (HS', 'Sutureless Appendectomy by Using Harmonic Scalpel', 'HS', 'Laparoscopic appendectomy']","['postoperative ileus', 'surgical site infection', 'Mean operating time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C0392220', 'cui_str': 'Surgical knife, device (physical object)'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}]","[{'cui': 'C0400877', 'cui_str': 'Postoperative ileus (disorder)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0307505,"Complications included postoperative ileus (group 1 = 8, group 2 = 10) and surgical site infection (group 1 = 4, group 2 = 4,  P  > .05).  ","[{'ForeName': 'Vipin', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Department of Surgery, UP University of Medical Sciences, Etawah, India.'}, {'ForeName': 'Shailendra Pal', 'Initials': 'SP', 'LastName': 'Singh', 'Affiliation': 'Department of Surgery, UP University of Medical Sciences, Etawah, India.'}, {'ForeName': 'Somendra Pal', 'Initials': 'SP', 'LastName': 'Singh', 'Affiliation': 'Department of Surgery, UP University of Medical Sciences, Etawah, India.'}, {'ForeName': 'Mradul', 'Initials': 'M', 'LastName': 'Bansal', 'Affiliation': 'Department of Surgery, UP University of Medical Sciences, Etawah, India.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': ""Department of Pediatric Surgery, King George's Medical University, Lucknow, India.""}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2019.0782']
134,31033154,Comparison of long-term clinical outcomes in multivessel coronary artery disease patients treated either with bioresoarbable polymer sirolimus-eluting stent or permanent polymer everolimus-eluting stent: 5-year results of the CENTURY II randomized clinical trial.,"OBJECTIVES


To assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial.
BACKGROUND


The use of coronary stenting in high-risk subgroups, like MVD patients, is rising. The clinical evidence, including long-term comparative analysis of the efficacy and safety benefits of different new-generation drug eluting stents, however, remains insufficient.
METHODS


Among 1,119 patients (intention-to-treat) enrolled in the CENTURY II prospective, randomized, single-blind, multicenter trial, a prespecified subgroup of 456 MVD patients were allocated by stratified randomization to treatment with BP-SES (n = 225) or PP-EES (n = 231). The previously reported primary endpoint of this study was freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization) at 9 months.
RESULTS


In this MVD substudy, baseline patient, lesion and procedure characteristics were similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p = .29 and 10.2 vs. 13.4%; p = .29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p = .33 and 0.9 vs. 1.7%; p = .43), respectively. Composite endpoint of cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations were also similar.
CONCLUSIONS


These results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.",2020,"At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p = .29 and 10.2 vs. 13.4%; p = .29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p = .33 and 0.9 vs. 1.7%; p = .43), respectively.","['patients with multivessel coronary artery disease (MVD', '1,119 patients (intention-to-treat', 'multivessel coronary artery disease patients treated either with bioresoarbable polymer sirolimus-eluting stent or permanent polymer everolimus-eluting stent', '456 MVD patients']","['sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster', 'BP-SES', 'coronary stenting', 'PP-EES']","['definite or probable stent thrombosis', 'cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations', 'rates of TLF', 'freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}]","[{'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",1119.0,0.16002,"At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p = .29 and 10.2 vs. 13.4%; p = .29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p = .33 and 0.9 vs. 1.7%; p = .43), respectively.","[{'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Iñiguez', 'Affiliation': 'Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chevalier', 'Affiliation': 'Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud, Massy, France.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': 'Department of Cardiology, Segeberger Kliniken, Bad Segeberg, Germany.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Neylon', 'Affiliation': 'SAOLTA Health Care Group, Galway University Hospital and NUI, Galway, Ireland.'}, {'ForeName': 'Victor A', 'Initials': 'VA', 'LastName': 'Jiménez', 'Affiliation': 'Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Kornowski', 'Affiliation': 'Cardiology Department, Rabin Medical Centre, Petah Tikva, Israel and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrie', 'Affiliation': 'Department of Cardiology, Rangueil University Hospital, Toulouse, France.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': 'Interventional Cardiology Department, La Paz University Hospital, Madrid, Spain.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': 'Cardiovascular Centre, Onze Lieve Vrouwe Ziekenhuis, Aalst, Belgium and Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Serra-Peñaranda', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIB-SantPau, CIBERCV, Universidad Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Guiducci', 'Affiliation': 'Interventional Cardiology Unit, S. Maria Nuova Hospital, Reggio Emilia, Italy.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Valdés-Chávarri', 'Affiliation': 'Cardiology Department, Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, Murcia, Spain.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Yajima', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wijns', 'Affiliation': 'The Lambe Institute, NUI Galway, Ireland.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiology and Catheterization Laboratory, Shonan Kamakura General Hospital, Kamakura, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28224']
135,31053766,Androgen decline and survival during docetaxel therapy in metastatic castration resistant prostate cancer (mCRPC).,"BACKGROUND


Multiple androgens drive prostate cancer progression and higher pre-treatment levels of androgens, even within the castrate range, have been previously shown to be associated with an improved overall survival (OS) in mCRPC. Docetaxel impairs microtubules, has androgen receptor (AR) inhibitory effects and is used in both the castration resistant and sensitive settings, where androgen dynamics may impact outcome. The present analysis evaluates the association of decline in serum androgen levels (Testosterone (T), Androstenedione (A) and DHEA in docetaxel-treated mCRPC patients with OS.
METHODS


Data from 1050 men treated on CALGB 90401 with docetaxel, prednisone and either bevacizumab or placebo were evaluated. Eligibility required progressive mCRPC and no prior chemotherapy. Pre-treatment, 6 week and progression serum assays for T, A and DHEA were performed via tandem Liquid Chromatography-Mass Spectrometry (LC-MS/MS). Changes in T, A and DHEA levels from baseline to 6 weeks were calculated as the ratio of 6-week over baseline. The proportional hazards model was used to assess the prognostic significance of changes in T, A, and DHEA from baseline to 6 weeks in predicting OS adjusting for known prognostic factors.
RESULTS


Median baseline values for T, A, and, DHEA were 1.0, 13.5, and 8.1 ng/dL respectively while 6 week levels were 0.64, 7.0, and 6.8 ng/dL respectively. Median OS for low testosterone decline is 20.9 months vs 26.3 months for high testosterone decline. In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001). Decline in A and DHEA were not significant predictors of OS. In multivariable analysis change in the serum changes did not predict PFS however the ratio of T at 6-weeks over baseline was prognostic of ≥50% decline in PSA with an odds ratio of 0.93 (95% CI = 0.85-0.98, p-value = 0.039).
CONCLUSIONS


Declines in testosterone during docetaxel treatment is associated with a longer survival, consistent with a favorable prognostic significance of higher serum androgens in the CRPC.",2020,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","['Data from 1050 men treated on CALGB 90401 with', 'metastatic castration resistant prostate cancer (mCRPC']","['Docetaxel', 'Androstenedione (A) and DHEA in docetaxel-treated mCRPC', 'docetaxel therapy', 'docetaxel, prednisone and either bevacizumab or placebo']","['testosterone levels', 'Median OS for low testosterone decline', 'serum androgen levels (Testosterone (T', 'overall survival (OS', 'hazard ratio for death', 'Androgen decline and survival', 'Changes in T, A and DHEA levels']","[{'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.188418,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","[{'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ryan', 'Affiliation': 'University of Minnesota and Masonic Cancer Center, Minneapolis, MN, USA. ryanc@umn.edu.'}, {'ForeName': 'Sandipan', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Russell', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York, NY, USA.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Dana-Farber/Partners Cancer Care, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0152-3']
136,31804853,Low-Cost Virtual Reality Headsets Reduce Perceived Pain in Healthy Adults: A Multicenter Randomized Crossover Trial.,"Objectives:  Recent studies have established the usage of virtual reality (VR) to help alleviate acute and chronic pain. VR technology can be cost prohibitive and cheaper alternatives are desired. In this study, a Google Cardboard headset ($15) combined with a smartphone was used as a low-cost VR device to assess efficacy in altering the perception of pain.  Materials and Methods:  The cold pressor test, a minimal-risk method, was used to simulate pain. Participants immersed their hands into ice water, with and without VR, in a crossover manner, and their pain perception data were recorded.  Results:  Forty-eight healthy volunteer participants completed the study between 2017 and 2018. Participants were randomized to right hand control, left control, right experimental, and left experimental groups, respectively, before the crossover. Data collected included pain threshold (time at which participants first reported pain), pain tolerance (time at which participants removed their hand), and pain intensity (highest reported pain level on a [1-10] scale). Approximately two-thirds of participants had improvements in pain threshold and pain tolerance with a mean improvement of +13.0 seconds ( P  = 0.0045) for pain threshold and +29.8 seconds ( P  = 0.0003) for pain tolerance. Pain intensity had a reduction of 0.43 points ( P  = 0.0371).  Conclusion:  Our results demonstrate that inexpensive VR devices, such as the Google Cardboard headset used in this study, may be a safe, portable, and cost-effective way to alter the perception and improve tolerance of pain.",2020,Pain intensity had a reduction of 0.43 points ( P  = 0.0371).  ,"['Healthy Adults', 'Forty-eight healthy volunteer participants completed the study between 2017 and 2018']","['virtual reality (VR', 'Google Cardboard headset ($15) combined with a smartphone']","['pain tolerance', 'tolerance of pain', 'pain), pain tolerance', 'pain intensity', 'pain threshold and pain tolerance', 'Pain intensity']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",48.0,0.0444544,Pain intensity had a reduction of 0.43 points ( P  = 0.0371).  ,"[{'ForeName': 'Payal', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Mayo Clinic School of Medicine, Rochester, Minnesota.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ivanov', 'Affiliation': 'Mayo Clinic School of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Shubhang', 'Initials': 'S', 'LastName': 'Bhatt', 'Affiliation': 'Mayo Clinic School of Medicine, Scottsdale, Arizona.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Mastorakos', 'Affiliation': 'Mayo Clinic School of Medicine, Scottsdale, Arizona.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Birckhead', 'Affiliation': 'Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Khera', 'Affiliation': 'Department of Hematology and Oncology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Vittone', 'Affiliation': 'General Internal Medicine, Mayo Clinic, Rochester, Minnesota.'}]",Games for health journal,['10.1089/g4h.2019.0052']
137,32314298,Comparative Study of Traditional Ablative CO 2  Laser-Assisted Topical Antifungal with only Topical Antifungal for Treating Onychomycosis: A Multicenter Study.,"BACKGROUND


The predominance of onychomycosis has been increasing recently. New medications and treatment modalities are being researched for better saturation of the antifungal agents through the nail plate topically because of the low resilience of some patients for the oral antifungal agents. Treatment of onychomycosis, mainly moderate to severe, can be very challenging, expensive, and time consuming.
OBJECTIVE


The objective of this clinical trial is to compare the efficacy and safety of a manually operated ablative CO 2  laser combined with a topical antifungal agent in patients with onychomycosis.
STUDY DESIGN


We conducted an open-label controlled prospective study of 160 eligible patients randomized into control and treatment groups with a 1:1 allocation in the department of dermatology in five different hospitals in Shanghai. It was a 6-month study where both groups were treated with a topical antifungal agent, with the treatment group also receiving ablation by the traditional CO 2  laser once a month for the first 3 months.
RESULTS


The clinical efficacy and mycological cure rate were significantly higher (p < 0.001) for the treatment group. Three (3.75%) patients from the control group and 18 (25%) patients from the treatment group achieved complete nail clearance along with negative potassium hydroxide and negative culture (primary endpoint) results at 24 weeks. Mycological clearance with at least moderate nail clearance (secondary endpoint) for the treatment group was also significantly higher (p < 0.001) for the laser treatment group. The laser treatment was mildly painful but tolerable by the patients. No drug interactions for both groups were encountered.
CONCLUSIONS


The ablative CO 2  laser is a primitive yet effective modality to be considered for the delivery of topical antifungal agents for the management of mild-to-severe onychomycosis. The laser has good tolerance in patients and is a common equipment found in most dermatology units even those without the latest medical technology.",2020,The clinical efficacy and mycological cure rate were significantly higher (p < 0.001) for the treatment group.,"['Treating Onychomycosis', '160 eligible patients randomized into control and treatment groups with a 1:1 allocation in the department of dermatology in five different hospitals in Shanghai', 'patients with onychomycosis']",['Traditional Ablative CO 2  Laser-Assisted Topical Antifungal with only Topical Antifungal'],"['Mycological clearance', 'clinical efficacy and mycological cure rate', 'efficacy and safety', 'nail clearance', 'complete nail clearance']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0040261', 'cui_str': 'Onychomycosis'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003308', 'cui_str': 'Antifungal-containing product'}]","[{'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",160.0,0.017543,The clinical efficacy and mycological cure rate were significantly higher (p < 0.001) for the treatment group.,"[{'ForeName': 'Bhavana', 'Initials': 'B', 'LastName': 'Rajbanshi', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China.'}, {'ForeName': 'Liangliang', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China.'}, {'ForeName': 'Qingyu', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China.'}, {'ForeName': 'Jiaoyang', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Dermatology and Venereology, Putuo District Central Hospital, Shanghai, China.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Dermatology and Venereology, Jiading District Anting Hospital, Shanghai, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Dermatology and Venereology, Jiading District Nanxiang Hospital, Shanghai, China.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Lv', 'Affiliation': 'Department of Dermatology and Venereology, Jiading District Central Hospital, Shanghai, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China.'}, {'ForeName': 'Jingjun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China. zhaojingjun2015@aliyun.com.'}]",Clinical drug investigation,['10.1007/s40261-020-00914-6']
138,32227638,Different Mismatch Concepts for Magnetic Resonance Imaging-Guided Thrombolysis in Unknown Onset Stroke.,"OBJECTIVE


To explore the prevalence of the perfusion-weighted imaging (PWI)-diffusion-weighted imaging (DWI) mismatch and response to intravenous thrombolysis in the WAKE-UP trial.
METHODS


We performed a prespecified post hoc analysis of ischemic stroke patients screened for DWI-fluid-attenuated inversion recovery (FLAIR) mismatch in WAKE-UP who underwent PWI. We defined PWI-DWI mismatch as ischemic core volume < 70ml, mismatch volume > 10ml, and mismatch ratio > 1.2. Primary efficacy end point was a modified Rankin Scale score of 0-1 at 90 days, adjusted for age and symptom severity.
RESULTS


Of 1,362 magnetic resonance imaging-screened patients, 431 underwent PWI. Of these, 57 (13%) had a double mismatch, 151 (35%) only a DWI-FLAIR mismatch, and 54 (13%) only a PWI-DWI mismatch. DWI-FLAIR mismatch was more prevalent than PWI-DWI mismatch (48%, 95% confidence interval [CI] = 43-53% vs 26%, 95% CI = 22-30%; p < 0.0001). Screening for either one of the mismatch profiles resulted in a yield of 61% (95% CI = 56-65%). Prevalence of PWI-DWI mismatch was similar in patients with (27%) or without (24%) DWI-FLAIR mismatch (p = 0.52). In an exploratory analysis in the small subgroup of 208 randomized patients with PWI, PWI-DWI mismatch status did not modify the treatment response (p for interaction = 0.73).
INTERPRETATION


Evaluating both the DWI-FLAIR and PWI-DWI mismatch patterns in patients with unknown time of stroke onset will result in the highest yield of thrombolysis treatment. The treatment benefit of alteplase in patients with a DWI-FLAIR mismatch seems to be driven not merely by the presence of a PWI-DWI mismatch, although this analysis was underpowered. ANN NEUROL 2020;87:931-938.",2020,Prevalence of PWI-DWI mismatch was similar in patients with (27%) or without (24%) DWI-FLAIR mismatch (p = 0.52).,"['1,362 magnetic resonance imaging (MRI) screened patients, 431 underwent PWI', 'ischemic stroke patients screened for DWI - fluid-attenuated inversion recovery (FLAIR) mismatch in WAKE-UP who underwent PWI', 'patients with a DWI-FLAIR mismatch']",['perfusion-weighted imaging (PWI) - diffusion-weighted imaging'],"['modified Rankin Scale score of 0-1 at 90\u2009days, adjusted for age and symptom severity', 'Prevalence of PWI-DWI mismatch']","[{'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0021945', 'cui_str': 'Inversion (morphologic abnormality)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}]","[{'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",208.0,0.139603,Prevalence of PWI-DWI mismatch was similar in patients with (27%) or without (24%) DWI-FLAIR mismatch (p = 0.52).,"[{'ForeName': 'Lauranne', 'Initials': 'L', 'LastName': 'Scheldeman', 'Affiliation': 'Department of Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Wouters', 'Affiliation': 'Department of Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Boutitie', 'Affiliation': 'Hospices Civils de Lyon, Service de Biostatistique, F-69003 Lyon, France; Université Lyon 1, F-69100, Villeurbanne, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dupont', 'Affiliation': 'Department of Neurosciences, Laboratory for Cognitive Neurology, KU Leuven-University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Soren', 'Initials': 'S', 'LastName': 'Christensen', 'Affiliation': 'GrayNumber Analytics, Lomma, Sweden.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Cheng', 'Affiliation': 'Department of Neurology, Head and Neurocenter, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ebinger', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jochen B', 'Initials': 'JB', 'LastName': 'Fiebach', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gerloff', 'Affiliation': 'Department of Neurology, Head and Neurocenter, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Keith W', 'Initials': 'KW', 'LastName': 'Muir', 'Affiliation': 'Institute of Neuroscience & Psychology, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Nighoghossian', 'Affiliation': 'Department of Stroke Medicine, Claude Bernard University Lyon 1, CREATIS National Center for Scientific Research Mixed Unit of Research 5220-National Institute of Health and Medical Research U1206, National Institute of Applied Sciences of Lyon, Lyon Civil Hospices, Lyon, France.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Pedraza', 'Affiliation': 'Department of Radiology, Institute of Diagnostic Imaging, Dr Josep Trueta Hospital, Girona Institute of Biomedical Research, Marti and Julia de Salt Hospital Park - Building M2, Girona, Spain.'}, {'ForeName': 'Claus Z', 'Initials': 'CZ', 'LastName': 'Simonsen', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Thijs', 'Affiliation': 'Stroke Theme, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Götz', 'Initials': 'G', 'LastName': 'Thomalla', 'Affiliation': 'Department of Neurology, Head and Neurocenter, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Lemmens', 'Affiliation': 'Department of Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of neurology,['10.1002/ana.25730']
139,32306247,Cost-Effectiveness of Insulin Degludec Versus Insulin Glargine U300 in the Netherlands: Evidence From a Randomised Controlled Trial.,"INTRODUCTION


This study aimed to evaluate the short-term cost-effectiveness of insulin degludec 200 units/mL (degludec) versus insulin glargine 300 units/mL (glargine U300) from a Dutch societal perspective.
METHODS


A previously published model estimated costs [2018 euros (EUR)] and effectiveness [quality-adjusted life years (QALYs)] with degludec compared with glargine U300 over a 1-year time horizon. The model captured hypoglycaemia rates and insulin dosing. Clinical outcomes were informed by CONCLUDE (NCT03078478), a head-to-head randomised controlled trial in insulin-experienced patients with type 2 diabetes.
RESULTS


Treatment with degludec was associated with mean annual cost savings (EUR 24.71 per patient) relative to glargine U300, driven by a lower basal insulin dose and lower severe hypoglycaemia rate with degludec compared with glargine U300. Lower rates of non-severe nocturnal and severe hypoglycaemia resulted in improved effectiveness (+ 0.0045 QALYs) with degludec relative to glargine U300. In sensitivity analyses, changes to the vast majority of model parameters did not materially affect model outcomes.
CONCLUSIONS


This short-term analysis, informed by the latest clinical trial evidence, demonstrated that degludec was a cost-effective treatment option relative to glargine U300. As such, our modelling analysis suggests that degludec would represent an efficient use of Dutch public healthcare resources in this patient population.",2020,Lower rates of non-severe nocturnal and severe hypoglycaemia resulted in improved effectiveness (+ 0.0045 QALYs) with degludec relative to glargine U300.,[],"['Insulin Degludec Versus Insulin Glargine', 'insulin degludec 200\xa0units/mL (degludec) versus insulin glargine 300\xa0units/mL (glargine U300']","['severe hypoglycaemia rate', 'effectiveness [quality-adjusted life years (QALYs', 'Lower rates of non-severe nocturnal and severe hypoglycaemia', 'mean annual cost savings']",[],"[{'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C2945590', 'cui_str': 'U/mL'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}]",,0.149607,Lower rates of non-severe nocturnal and severe hypoglycaemia resulted in improved effectiveness (+ 0.0045 QALYs) with degludec relative to glargine U300.,"[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'University Hospital Llandough, Penarth, UK. marclyndon1@hotmail.com.'}, {'ForeName': 'Robert G J', 'Initials': 'RGJ', 'LastName': 'Moes', 'Affiliation': 'Novo Nordisk B.V., Alphen aan den Rijn, Netherlands.'}, {'ForeName': 'Katrine S', 'Initials': 'KS', 'LastName': 'Pedersen', 'Affiliation': 'Novo Nordisk Region Europe, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gundgaard', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Department of Internal Medicine, Medical University of Graz, Graz, Austria.'}]",Advances in therapy,['10.1007/s12325-020-01332-y']
140,32290739,The clinical outcomes of rituximab biosimilar CT-P10 (Truxima ® ) with CHOP as first-line treatment for patients with diffuse large B-cell lymphoma: real-world experience.,"We evaluated real-world effectiveness and safety of CT-P10 (Truxima ® ) compared with originator rituximab in diffuse large B-cell lymphoma (DLBCL) treatment. Before and after the introduction of CT-P10 to our institute (November 2017), 221 newly-diagnosed DLBCL patients received rituximab with standard cyclophosphamide, vincristine, doxorubicin and prednisone. Patients received originator rituximab throughout ( n  = 95), switched from originator rituximab to CT-P10 ( n  = 36), or received CT-P10 throughout ( n  = 90). There were no significant differences between groups in overall response rate (91.6% vs 94.4% vs 96.7%, respectively;  p  = 0.403) or complete response rate (84.2% vs 77.8% vs 86.7%, respectively;  p  = 0.467). Kaplan-Meier survival curves also showed no significant differences in progression-free survival and overall survival between groups (log-rank  p  = 0.794 and  p  = 0.955, respectively). Safety profiles were comparable between treatment groups. These data support the ability of CT-P10 to successfully replace originator rituximab in DLBCL treatment and, given the lowered financial barrier, to improve the overall prognosis for DLBCL patients.",2020,"Kaplan-Meier survival curves also showed no significant differences in progression-free survival and overall survival between groups (log-rank  p  = 0.794 and  p  = 0.955, respectively).","['diffuse large B-cell lymphoma (DLBCL) treatment', 'patients with diffuse large B-cell lymphoma']","['rituximab biosimilar CT-P10 (Truxima ® ) with CHOP', 'rituximab with standard cyclophosphamide, vincristine, doxorubicin and prednisone', 'CT-P10 (Truxima ® ', 'originator rituximab', 'originator rituximab to CT-P10']","['progression-free survival and overall survival', 'overall response rate', 'Safety profiles', 'complete response rate']","[{'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4287770', 'cui_str': 'CT-P10'}, {'cui': 'C4741331', 'cui_str': 'Truxima'}, {'cui': 'C0055598', 'cui_str': 'CHOP protocol'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",,0.0288692,"Kaplan-Meier survival curves also showed no significant differences in progression-free survival and overall survival between groups (log-rank  p  = 0.794 and  p  = 0.955, respectively).","[{'ForeName': 'Kyoungmin', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Joo Young', 'Initials': 'JY', 'LastName': 'Ha', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ah Ra', 'Initials': 'AR', 'LastName': 'Jung', 'Affiliation': 'Department of Otolaryngology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yoon Sei', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-Wook', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Sook', 'Initials': 'JS', 'LastName': 'Ryu', 'Affiliation': 'Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Eun Jin', 'Initials': 'EJ', 'LastName': 'Chae', 'Affiliation': 'Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung Won', 'Initials': 'KW', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jooryung', 'Initials': 'J', 'LastName': 'Huh', 'Affiliation': 'Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Chan-Sik', 'Initials': 'CS', 'LastName': 'Park', 'Affiliation': 'Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dok Hyun', 'Initials': 'DH', 'LastName': 'Yoon', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Cheolwon', 'Initials': 'C', 'LastName': 'Suh', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}]",Leukemia & lymphoma,['10.1080/10428194.2020.1742906']
141,31303542,Surgical Cross-Training With Surgery Naive Learners: Implications for Resident Training.,"OBJECTIVE


While current literature has explored the transferability of laparoscopic surgical skills to robotic surgery, this study looks to investigate the transferability of surgical skills between robotic surgical simulation and simulated traditional laparoscopy.
DESIGN


Participants completed a survey regarding prior surgery exposure and other confounding factors including previous video game experience and self-assessed hand-eye coordination. Following orientation to the laparoscopic simulator (LS) and robotic surgical simulator (RoSS), participants were timed performing the Balloon Grasp and Ball Drop tasks on the RoSS and the Peg Transfer and Ball Drop tasks on the LS. Participants were then randomized to either the laparoscopic or RoSS arm and timed performing the Ball Drop task 10 times and then reassessed performing the Ball Drop using the unpracticed modality.
SETTING


Clinical Simulation Laboratory at the University of Vermont PARTICIPANTS: A total of 31 medical students with limited experience in laparoscopic and robotic surgery.
RESULTS


There were no statistically significant differences in the demographics or prior surgical and videogame experience between the participants in the laparoscopic and robotic arms of the study (X 2  = 0.72, p = 0.75). Timed initial assessment of the RoSS Balloon Grasp (p = 0.84) and Ball Drop (p = 0.79) tasks and the LS Peg Transfer (p = 0.14) and Ball Drop (p = 0.44) tasks were not statistically different between the 2 arms. The simulator modality which was practiced yielded the greatest improvement. The degree of improvement on the unpracticed modality was not statistically different between the groups (p = 0.57), and it was not significantly better than 2 rounds of sequential practice on the practiced modality (LS, p = 0.98 and RoSS, p = 0.55).
CONCLUSIONS


With practice, both groups increased surgical skill on the unpracticed modality. However, this degree of improvement was equal, suggesting there is no transferability of skills between laparoscopy and robotics.",2019,"The degree of improvement on the unpracticed modality was not statistically different between the groups (p = 0.57), and it was not significantly better than 2 rounds of sequential practice on the practiced modality (LS, p = 0.98 and RoSS, p = 0.55).
","['Participants completed a survey regarding prior surgery exposure and other confounding factors including previous video game experience and self-assessed hand-eye coordination', 'With Surgery Naive Learners', 'Clinical Simulation Laboratory at the University of Vermont PARTICIPANTS', '31 medical students with limited experience in laparoscopic and robotic surgery']","['laparoscopic or RoSS arm and timed performing the Ball Drop task 10 times and then reassessed performing the Ball Drop using the unpracticed modality', 'Surgical Cross-Training', 'laparoscopic simulator (LS) and robotic surgical simulator (RoSS), participants were timed performing the Balloon Grasp and Ball Drop tasks on the RoSS and the Peg Transfer and Ball Drop tasks on the LS']","['demographics or prior surgical and videogame experience', 'surgical skill', 'degree of improvement on the unpracticed modality', 'Timed initial assessment of the RoSS Balloon Grasp', 'LS Peg Transfer']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0009673', 'cui_str': 'Confounding Variables'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0042537', 'cui_str': 'Vermont'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0220843', 'cui_str': 'Grip'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0220843', 'cui_str': 'Grip'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]",,0.0636344,"The degree of improvement on the unpracticed modality was not statistically different between the groups (p = 0.57), and it was not significantly better than 2 rounds of sequential practice on the practiced modality (LS, p = 0.98 and RoSS, p = 0.55).
","[{'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Ashley', 'Affiliation': 'Department of Surgery, Gynecology Service, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Donaldson', 'Affiliation': 'University of Vermont, College of Medicine, Burlington, Vermont.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Evans', 'Affiliation': 'Department of Anesthesiology, University of Vermont College of Medicine, Burlington, Vermont.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Nielsen', 'Affiliation': 'Department of Obstetrics and Gynecology, Western Michigan University Homer Stryker M.D. College of Medicine, Kalamazoo, Michigan.'}, {'ForeName': 'Elise N', 'Initials': 'EN', 'LastName': 'Everett', 'Affiliation': 'Division of Gynecologic Oncology, University of Vermont College of Medicine, Burlington, Vermont. Electronic address: elise.everett@uvmhealth.org.'}]",Journal of surgical education,['10.1016/j.jsurg.2019.06.015']
142,31826326,"The effect of frequent hemodialysis on matrix metalloproteinases, their tissue inhibitors, and FGF23: Implications for blood pressure and left ventricular mass modification in the Frequent Hemodialysis Network trials.","BACKGROUND


Frequent hemodialysis modifies serum phosphorus, blood pressure, and left ventricular mass (LVM). We ascertained whether frequent hemodialysis is associated with specific changes in biomarker profile among patients enrolled in the frequent hemodialysis network (FHN) trials.
METHODS


This was a post hoc analysis of biomarkers among patients enrolled to the FHN trials. In particular, we hypothesized that frequent hemodialysis is associated with changes in a specific set of biomarkers which are linked with changes in blood pressure or LVM.
RESULTS


Among 332 randomized patients, 243 had biomarker data available. Of these, 124 patients were assigned to 3-times-a-week hemodialysis (94 [Daily Trial] and 30 [Nocturnal Trial]) and 119 patients were assigned to 6-times-a-week hemodialysis (87 [Daily Trial] and 32 [Nocturnal Trial]). Frequent hemodialysis lowered phosphate, blood pressures, LVM, log fibroblast growth factor (FGF)23, and tissue inhibitors of metalloproteinase (TIMP)-2 levels. The fall in phosphate was associated with changes in FGF23 (r = 0.48, P < 0.001) [Daily Trial] and (r = 0.55, P < 0.001) [Nocturnal Trial]) and tended to be associated with changes in systolic blood pressure (r = 0.18, P = 0.057) [Daily Trial] and (r = 0.31, P = 0.04) [Nocturnal Trial]. Within the Daily Trial, changes in MMP2 (r = 0.20, P = 0.034) were associated with changes in LVM. In the Nocturnal Trial, changes in TIMP-1 (r = 0.37, P = 0.029) and MMP 9 (r = -0.38, P = 0.01) were associated with LVM changes. MMP2 changes were associated with changes in systolic blood pressure.
CONCLUSIONS


Reduction of serum phosphate by frequent hemodialysis may modulate FGF23 levels and systolic blood pressure. Markers of matrix turnover are associated with LVM changes. Frequent hemodialysis may affect pathological mediators of chronic kidney disease-mineral bone-metabolism disorder.",2020,"Frequent hemodialysis lowered phosphate, blood pressures, LVM, log fibroblast growth factor (FGF)23, and tissue inhibitors of metalloproteinase (TIMP)-2 levels.","['patients enrolled in the frequent hemodialysis network (FHN) trials', '332 randomized patients, 243 had biomarker data available', '124 patients were assigned to 3-times-a-week hemodialysis (94 [Daily Trial] and 30 [Nocturnal Trial]) and 119 patients were assigned to', 'patients enrolled to the FHN trials']",['6-times-a-week hemodialysis'],"['FGF23 levels and systolic blood pressure', 'systolic blood pressure', 'blood pressure or LVM', 'MMP2', 'FGF23', 'Frequent hemodialysis lowered phosphate, blood pressures, LVM, log fibroblast growth factor (FGF)23, and tissue inhibitors of metalloproteinase (TIMP)-2 levels', 'TIMP-1', 'serum phosphorus, blood pressure, and left ventricular mass (LVM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}]","[{'cui': 'C0585299', 'cui_str': '6x/wk'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C3272931', 'cui_str': 'FGF-23'}, {'cui': 'C0145946', 'cui_str': 'Tissue Inhibitor of Metalloproteinase-2'}, {'cui': 'C0145947', 'cui_str': 'TIMP-1'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}]",332.0,0.0248733,"Frequent hemodialysis lowered phosphate, blood pressures, LVM, log fibroblast growth factor (FGF)23, and tissue inhibitors of metalloproteinase (TIMP)-2 levels.","[{'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Chan', 'Affiliation': 'University Health Network, Toronto General Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Kaysen', 'Affiliation': 'University of California Davis, Davis, California, USA.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Beck', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Minwei', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Joan C', 'Initials': 'JC', 'LastName': 'Lo', 'Affiliation': 'Kaiser Permanente Northern California, Oakland, California, USA.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Kliger', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12807']
143,31616941,The circadian system modulates the rate of recovery of systolic blood pressure after exercise in humans.,"STUDY OBJECTIVES


Recovery rates of systolic blood pressure (BP) and heart rate (HR) after exercise have been used to assess cardiovascular fitness, and slower recovery rates are predictors of coronary heart disease and cardiac mortality. The endogenous circadian system is known to modulate BP and HR at rest and during exercise. Here, we examined whether the post-exercise recovery rates of BP and HR are also under circadian control.
METHODS


Twelve healthy adults (mean age = 26 ± 6 (SD) years; 6 female) participated in a 240 h forced desynchrony protocol in dim light where all behaviors, including 15 min cycle exercise tests at 60% maximal HR, were uniformly distributed across the circadian cycle. Circadian phases were assigned based on the rhythm of core body temperature. For each session, HR was measured continuously, and BP every 3-5 min throughout baseline, exercise, and recovery. Recovery was quantified as the proportional return to pre-exercise baseline levels following exercise ([peak exercise-recovery]/[peak exercise-baseline) × 100%], whereby 100% represents full recovery to baseline).
RESULTS


There was a significant circadian rhythm in systolic BP recovery, with fastest recovery at the circadian phase corresponding to late afternoon (equivalent to ~5 pm) and slower recovery across the early morning (~8:30 am; p = 0.029, peak-to-trough: 9.2%). There were no significant circadian variations in post-exercise recovery rates of diastolic BP or HR.
CONCLUSIONS


The circadian system modulates the rate of recovery of systolic BP after exercise with fastest recovery in the biological afternoon. These data could have implications for exercise prescription and interpretation of clinical tests of stress recovery.",2020,"There were no significant circadian variations in post-exercise recovery rates of diastolic BP or HR.
","['12 healthy adults (mean age = 26±6 (SD) years; 6 female', 'humans']",['240-h forced desynchrony protocol in dim light'],"['diastolic BP or HR', 'systolic blood pressure (BP) and heart rate (HR', 'circadian rhythm in systolic BP recovery', 'cardiovascular fitness', 'rate of recovery of systolic BP', 'systolic blood pressure']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0008810', 'cui_str': 'Nycthemeral Rhythm'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",12.0,0.134676,"There were no significant circadian variations in post-exercise recovery rates of diastolic BP or HR.
","[{'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Frank Ajl', 'Initials': 'FA', 'LastName': 'Scheer', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Shea', 'Affiliation': 'Oregon Institute of Occupational Health Sciences, Oregon Health and Science University, Portland, OR.'}]",Sleep,['10.1093/sleep/zsz253']
144,31945197,"Evaluating the safety and potential activity of URO-902 (hMaxi-K) gene transfer by intravesical instillation or direct injection into the bladder wall in female participants with idiopathic (non-neurogenic) overactive bladder syndrome and detrusor overactivity from two double-blind, imbalanced, placebo-controlled randomized phase 1 trials.","AIMS


Two phase 1 trials were performed in healthy women with the overactive bladder (OAB) syndrome and urodynamically demonstrated detrusor overactivity (DO), with the aim to demonstrate the safety and potential efficacy of URO-902, which comprises a gene therapy plasmid vector expressing the human big potassium channel α subunit.
METHODS


ION-02 (intravesical instillation) and ION-03 (direct injection) were double-blind, placebo-controlled, multicenter studies without overlap in enrollment between studies. Active doses were administered and evaluated sequentially (lowest dose first) for safety. ION-02 participants received either 5000 µg or 10 000 µg URO-902, or placebo. ION-03 participants received either 16 000 or 24 000 µg URO-902, or placebo, injected directly into the bladder wall using cystoscopy. Primary outcome variables were safety parameters occurring subsequent to URO-902 administration; secondary efficacy variables also were evaluated.
RESULTS


Among the safety outcomes, there were no dose-limiting toxicities or significant adverse events (AEs) preventing dose escalation during either trial, and no participants withdrew due to AEs. For efficacy, in ION-02 (N = 21), involuntary detrusor contractions on urodynamics at 24 weeks in patients receiving URO-902 (P < .0508 vs placebo) and mean urgency incontinence episodes in the 5000 µg group (P = .0812 vs placebo) each showed a downward trend. In ION-03 (N = 13), significant reduction versus placebo in urgency episodes (16 000 µg, P = .036; 24 000 µg, P = .046) and number of voids (16 000 µg, -2.16, P = .044; 24 000 µg, -2.73, P = .047) were observed 1 week after injection.
CONCLUSION


Promising safety and efficacy results in these preliminary phase 1 studies suggest gene transfer may be a promising therapy for OAB/DO, warranting further investigation.",2020,"Among the safety outcomes, there were no dose-limiting toxicities or significant adverse events (AEs) preventing dose escalation during either trial, and no participants withdrew due to AEs.","['female participants with idiopathic (non-neurogenic) overactive bladder syndrome and detrusor overactivity from two double-blind, imbalanced', 'healthy women with the overactive bladder (OAB) syndrome and urodynamically demonstrated detrusor overactivity (DO']","['placebo', '5000\u2009µg or 10\u2009000\u2009µg URO-902, or placebo', 'ION-02', 'ION-02 (intravesical instillation) and ION-03 (direct injection', '16\u2009000 or 24\u2009000\u2009µg URO-902, or placebo, injected directly into the bladder wall using cystoscopy', 'URO-902 (hMaxi-K) gene transfer by intravesical instillation or direct injection']","['number of voids', 'involuntary detrusor contractions on urodynamics', 'mean urgency incontinence episodes', 'urgency episodes', 'safety parameters occurring subsequent to URO-902 administration; secondary efficacy variables']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1536696', 'cui_str': 'Overactivity'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319610', 'cui_str': '5000 (qualifier value)'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0021917', 'cui_str': 'Instillation, Bladder'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",,0.374408,"Among the safety outcomes, there were no dose-limiting toxicities or significant adverse events (AEs) preventing dose escalation during either trial, and no participants withdrew due to AEs.","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rovner', 'Affiliation': 'Department of Urology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Toby C', 'Initials': 'TC', 'LastName': 'Chai', 'Affiliation': 'Department of Urology, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Jacobs', 'Affiliation': 'Ion Channel Innovations, LLC, New York, New York.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Christ', 'Affiliation': 'Department of Orthopaedics, University of Virginia Medical School, Charlottesville, Virginia.'}, {'ForeName': 'Karl-Erik', 'Initials': 'KE', 'LastName': 'Andersson', 'Affiliation': 'Department of Urology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Efros', 'Affiliation': 'Accumed Research Associates, Garden City, New York.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Nitti', 'Affiliation': 'Departments of Urology and Obstetrics and Gynecology, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Davies', 'Affiliation': 'Department of Urology, Albert Einstein College of Medicine, New York, New York.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'McCullough', 'Affiliation': 'Department of Urology, Tufts University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Melman', 'Affiliation': 'Department of Urology, Albert Einstein College of Medicine, New York, New York.'}]",Neurourology and urodynamics,['10.1002/nau.24272']
145,31981106,Effects of Netarsudil and Latanoprost Alone and in Fixed Combination on Corneal Endothelium and Corneal Thickness: Post-Hoc Analysis of MERCURY-2.,"INTRODUCTION


To describe the changes in endothelial cell density (ECD), the coefficient of variation (CV), the percentage of hexagonal cells (%HEX), and central corneal thickness (CCT) following 3 months of therapy with netarsudil 0.02%/latanoprost 0.005% fixed combination, and to compare these changes with those seen with netarsudil 0.02% or latanoprost 0.005% in eyes with ocular hypertension or open-angle glaucoma.
METHODS


A subset of subjects enrolled in a Phase 3 evaluation of the intraocular pressure-lowering efficacy and safety of netarsudil 0.02%/latanoprost 0.005% fixed combination once daily (QD) versus each of its individual components underwent corneal endothelial cell imaging by specular microscopy and ultrasound pachymetry at baseline and following 3 months of therapy. Images were evaluated in masked fashion at an independent reading center. Changes from baseline to 3 months in ECD, CV, %HEX, and CCT were compared between treatment groups.
RESULTS


Data from 415 subjects obtained at both baseline and Month 3 were included in this post hoc analysis. Changes from baseline to Month 3 in ECD, CV, and %HEX were clinically insignificant in all three groups, and the changes in the netarsudil/latanoprost fixed combination group demonstrated no statistical difference from those seen in the netarsudil and latanoprost groups. Mean CCT decreased more in the fixed combination group (- 6.4 µm) than in either the netarsudil group (- 3.3 µm, p = 0.0248) or the latanoprost group (- 1.2 µm, p < 0.0001).
CONCLUSIONS


Netarsudil 0.2%/latanoprost 0.005% fixed combination QD for 3 months in eyes with ocular hypertension or open-angle glaucoma had no clinically significant effects on endothelial cell density or morphology. The significant decrease in CCT in the fixed combination group compared to the two individual component groups may indicate that the potential effects of each drug on CCT are additive, although the magnitude of the observed effects is likely of negligible clinical significance. CLINICALTRIALS.
GOV IDENTIFIER


NCT02674854.",2020,"Changes from baseline to Month 3 in ECD, CV, and %HEX were clinically insignificant in all three groups, and the changes in the netarsudil/latanoprost fixed combination group demonstrated no statistical difference from those seen in the netarsudil and latanoprost groups.","['415 subjects obtained at both baseline and Month 3', 'eyes with ocular hypertension or open-angle glaucoma']","['Netarsudil 0.2%/latanoprost 0.005% fixed combination QD', 'Netarsudil and Latanoprost Alone and in Fixed Combination', 'latanoprost', 'netarsudil 0.02%/latanoprost 0.005% fixed combination once daily (QD']","['endothelial cell density (ECD), the coefficient of variation (CV), the percentage of hexagonal cells (%HEX), and central corneal thickness (CCT', 'Corneal Endothelium and Corneal Thickness', 'Mean CCT', 'CCT', 'endothelial cell density or morphology']","[{'cui': 'C4517772', 'cui_str': 'Four hundred and fifteen'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0028840', 'cui_str': 'Ocular Hypertension'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}]","[{'cui': 'C4535718', 'cui_str': 'netarsudil'}, {'cui': 'C4517389', 'cui_str': '0.005'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0090306', 'cui_str': 'latanoprost acid'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0014259', 'cui_str': 'Corneal Endothelium'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}]",415.0,0.0504411,"Changes from baseline to Month 3 in ECD, CV, and %HEX were clinically insignificant in all three groups, and the changes in the netarsudil/latanoprost fixed combination group demonstrated no statistical difference from those seen in the netarsudil and latanoprost groups.","[{'ForeName': 'C Ellis', 'Initials': 'CE', 'LastName': 'Wisely', 'Affiliation': 'Duke University Eye Center, Durham, NC, USA.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Sheng', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Irvine, CA, USA. hsheng@aeriepharma.com.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Heah', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Irvine, CA, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Duke University Eye Center, Durham, NC, USA.'}]",Advances in therapy,['10.1007/s12325-020-01227-y']
146,31993943,Design and Rationale of a Scandinavian Multicenter Randomized Study Evaluating if Once-Daily Tacrolimus Versus Twice-Daily Cyclosporine Reduces the 3-year Incidence of Chronic Lung Allograft Dysfunction After Lung Transplantation (ScanCLAD Study).,"BACKGROUND


A low level of evidence exists regarding the choice of calcineurin inhibitor (CNI) for immunosuppression after lung transplantation (LTx). Therefore, we designed a randomized clinical trial according to good clinical practice rules to compare tacrolimus with cyclosporine after LTx.
METHODS


The ScanCLAD study is an investigator-initiated, pragmatic, controlled, randomized, open-label, multicenter study evaluating if an immunosuppressive protocol based on anti-thymocyte globulin (ATG) induction, once-daily tacrolimus dose, mycophenolate mofetil, and corticosteroid reduces the incidence of chronic lung allograft dysfunction (CLAD) after LTx, compared to a cyclosporine-based protocol with all other immunosuppressive and prophylactic drugs being identical between groups. All patients will be followed for 3 years to determine the main endpoint of CLAD. The study is designed for superiority, and power calculations show that 242 patients are needed. Also, the study is designed with more than 10 substudies addressing other important and unresolved issues in LTx. In addition, the ScanCLAD study enabled the synchronization of the treatment and follow-up protocols of the lung transplantation programs of all five Scandinavian lung transplantation centers.
PLANNED OUTCOMES


Recruitment started in 2016. At the end of April 2019, 227 patients were randomized. We anticipate the last patient to be randomized in autumn 2019, and thus the last patient visits will be in 2022. The ScanCLAD study is enrolling and investigates which CNI is to be preferred from a CLAD perspective after LTx.
TRIAL REGISTRY NUMBER


ScanCLAD trial registered at ClinicalTrials.gov before patient enrollment (NCT02936505). EUDRACT number 2015-004137-27.",2020,"In addition, the ScanCLAD study enabled the synchronization of the treatment and follow-up protocols of the lung transplantation programs of all five Scandinavian lung transplantation centers.
","['242 patients are needed', '227 patients were randomized']","['immunosuppressive protocol based on anti-thymocyte globulin (ATG) induction, once-daily tacrolimus dose, mycophenolate mofetil, and corticosteroid', 'cyclosporine', 'tacrolimus with cyclosporine', 'Tacrolimus Versus Twice-Daily Cyclosporine', 'calcineurin inhibitor (CNI']","['3-year Incidence of Chronic Lung Allograft Dysfunction', 'incidence of chronic lung allograft dysfunction (CLAD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0009072', 'cui_str': 'Garments'}]",227.0,0.114135,"In addition, the ScanCLAD study enabled the synchronization of the treatment and follow-up protocols of the lung transplantation programs of all five Scandinavian lung transplantation centers.
","[{'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Dellgren', 'Affiliation': 'Department of Cardiothoracic Surgery, Sahlgrenska, University Hospital, Gothenburg, Sweden. goran.dellgren@vgregion.se.'}, {'ForeName': 'Thomas Kromann', 'Initials': 'TK', 'LastName': 'Lund', 'Affiliation': 'Section for Lung Transplantation, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Raivio', 'Affiliation': 'Department of Cardiac Surgery, Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Leuckfeld', 'Affiliation': 'Department of Respiratory Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Svahn', 'Affiliation': 'Department of Pulmonology, Lund University Hospital, Lund, Sweden.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Magnusson', 'Affiliation': 'Transplant Institute, Sahlgrenska, University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Gerdt C', 'Initials': 'GC', 'LastName': 'Riise', 'Affiliation': 'Transplant Institute, Sahlgrenska, University Hospital, Gothenburg, Sweden.'}]",Advances in therapy,['10.1007/s12325-020-01224-1']
147,32020565,"Prolonged-Release (PR) Oxycodone/Naloxone Improves Bowel Function Compared with Oxycodone PR and Provides Effective Analgesia in Chinese Patients with Non-malignant Pain: A Randomized, Double-Blind Trial.","INTRODUCTION


Prolonged-release oxycodone/naloxone (OXN PR), combining an opioid analgesic with selective blockade of enteric µ-opioid receptors, provided effective analgesia and improved bowel function in patients with moderate-to-severe pain and opioid-induced constipation in clinical trials predominantly conducted in Western countries. This double-blind randomized controlled trial investigated OXN PR (N = 116) versus prolonged-release oxycodone (OXY PR, N = 115) for 8 weeks at doses up to 50 mg/day in patients with moderate-to-severe, chronic, non-malignant musculoskeletal pain and opioid-induced constipation recruited in China.
METHODS


A total of 234 patients at least 18 years of age with non-malignant musculoskeletal pain for more than 4 weeks that was moderate-to-severe in intensity and required round-the-clock opioid therapy were randomized (1:1) to OXN PR or OXY PR. The primary endpoint was bowel function using the Bowel Function Index (BFI). Secondary endpoints included safety, Brief Pain Inventory-Short Form (BPI-SF), use of analgesic and laxative rescue medication, and health-related quality of life (EQ-5D).
RESULTS


While BFI scores were comparable at baseline, at week 8 improvements were greater with OXN PR vs OXY PR (least squares mean [LSM] difference (95% CI) - 9.1 (- 14.0, - 4.2); P < 0.001. From weeks 2 to 8, mean BFI scores were in the range of normal bowel function (≤ 28.8) with OXN PR but were in the range of constipation (> 28.8) at all timepoints with OXY PR. Analgesia with OXN PR was similar and non-inferior to OXY PR on the basis of modified BPI-SF average 24-h pain scores at week 8: LSM difference (95% CI) - 0.3 (- 0.5, - 0.1); P < 0.001. The most frequent treatment-related AEs were nausea (OXN PR 5% vs OXY PR 6%) and dizziness (4% vs 4%).
CONCLUSION


OXN PR provided clinically meaningful improvements in bowel function and effective analgesia in Chinese patients with moderate-to-severe musculoskeletal pain and pre-existing opioid-induced constipation.
TRIAL REGISTRATION


ClinicalTrials.gov, identifier NCT01918098.",2020,"Analgesia with OXN PR was similar and non-inferior to OXY PR on the basis of modified BPI-SF average 24-h pain scores at week 8: LSM difference (95% CI) - 0.3 (- 0.5, - 0.1); P < 0.001.","['Chinese Patients with Non-malignant Pain', 'patients with moderate-to-severe, chronic, non-malignant musculoskeletal pain and opioid-induced constipation recruited in China', 'Chinese patients with moderate-to-severe musculoskeletal pain and pre-existing opioid-induced constipation', '234 patients at least 18\xa0years of age with non-malignant musculoskeletal pain for more than 4\xa0weeks that was moderate-to-severe in intensity and required round-the-clock opioid therapy', 'patients with moderate-to-severe pain and opioid-induced constipation in clinical trials predominantly conducted in Western countries']","['Naloxone', 'OXN PR', 'OXN PR (N\u2009=\u2009116) versus prolonged-release oxycodone (OXY PR, N\u2009=\u2009115', 'OXN PR or OXY PR', 'naloxone (OXN PR', 'Oxycodone PR', 'Oxycodone']","['Bowel Function', 'modified BPI-SF average 24-h pain scores', 'Prolonged-Release (PR', 'bowel function using the Bowel Function Index (BFI', 'nausea (OXN PR', 'bowel function and effective analgesia', 'safety, Brief Pain Inventory-Short Form (BPI-SF), use of analgesic and laxative rescue medication, and health-related quality of life (EQ-5D', 'mean BFI scores', 'dizziness', 'BFI scores']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}, {'cui': 'C3160897'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C4544856', 'cui_str': 'Prolonged-release (release characteristic)'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}]","[{'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C4544856', 'cui_str': 'Prolonged-release (release characteristic)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",234.0,0.404247,"Analgesia with OXN PR was similar and non-inferior to OXY PR on the basis of modified BPI-SF average 24-h pain scores at week 8: LSM difference (95% CI) - 0.3 (- 0.5, - 0.1); P < 0.001.","[{'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Leng', 'Affiliation': 'Rheumatology and Immunology Department, Peking Union Medical College Hospital, Peking, China.'}, {'ForeName': 'Fengxiao', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Rheumatology and Immunology Department, Hebei General Hospital, Shijiazhuang, China.'}, {'ForeName': 'Shanglong', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Anesthesiology Department, Wuhan Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xisheng', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'Osteology Department, Peking Union Medical College Hospital, Peking, China.'}, {'ForeName': 'Kaizhi', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Anesthesiology Department, The First Affiliated Hospital of Third Military Medical University (TMMU), Chongqing, China.'}, {'ForeName': 'Gouzhong', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Anesthesiology Department, Fuzhou General Hospital of Nanjing Military Command, Fuzhou, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Anesthesiology Department, The General Hospital of Shenyang Military Region, Shenyang, China.'}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Anesthesiology Department, Peking Union Medical College Hospital, Peking, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Rheumatology and Immunology Department, Peking Union Medical College Hospital, Peking, China. xiaofeng.zeng@cstar.org.cn.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hopp', 'Affiliation': 'Mundipharma Research GmbH & Co.KG, Limburg, Germany.'}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Lu', 'Affiliation': 'Mundipharma (China) Pharmaceutical Co. Ltd, Beijing, China.'}]",Advances in therapy,['10.1007/s12325-020-01244-x']
148,32016788,Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration: 52- and 96-Week Findings from ALTAIR : A Randomized Controlled Trial.,"PURPOSE


To evaluate efficacy and safety of intravitreal injections of aflibercept (IVT-AFL) treat-and-extend (T&E) dosing regimens in treatment-naïve patients with exudative age-related macular degeneration (AMD).
METHODS


Adults aged at least 50 years old with exudative AMD and best-corrected visual acuity (BCVA) of 73-25 Early Treatment Diabetic Retinopathy Study (ETDRS) letters were included. Patients received three monthly doses of IVT-AFL 2 mg. At week 16, patients were randomized 1:1 to IVT-AFL T&E with either 2- or 4-week adjustments. The primary endpoint was mean change in BCVA from baseline to week 52. Outcomes were assessed at weeks 52 and 96.
RESULTS


Baseline characteristics were comparable between the groups (n = 123 each). Over 52 weeks, mean number of injections was 7.2 and 6.9 and mean last injection interval was 10.7 and 11.8 weeks, for the 2- and 4-week groups, respectively. From baseline, mean change in BCVA was + 9.0 and + 8.4 letters (week 52) and + 7.6 and + 6.1 letters (week 96); mean change in central retinal thickness was - 134.4 µm and - 126.1 µm (week 52) and - 130.5 µm and - 125.3 µm (week 96). Last injection interval before week 52 was at least 12 weeks in 42.3% and 49.6% of patients and 56.9% and 60.2% before week 96. Over 96 weeks, mean number of injections was 10.4 (both groups). The safety profile of IVT-AFL was consistent with previous reports.
CONCLUSIONS


IVT-AFL administered using two different T&E regimens for treatment-naïve exudative AMD improved functional and anatomic outcomes at week 52 and outcomes were maintained to week 96. Outcomes were similar between the 2- and 4-week groups.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02305238.",2020,"Outcomes were similar between the 2- and 4-week groups.
","['Adults aged at least 50\xa0years old with exudative AMD and best-corrected visual acuity (BCVA) of 73-25 Early Treatment Diabetic Retinopathy Study (ETDRS) letters were included', 'Exudative Age-Related Macular Degeneration', 'treatment-naïve patients with exudative age-related macular degeneration (AMD']","['IVT-AFL', 'ALTAIR ', 'Intravitreal Aflibercept Treat-and-Extend Regimens', 'aflibercept (IVT-AFL) treat-and-extend (T&E', 'IVT-AFL T&E']","['Efficacy and Safety', 'mean change in BCVA', 'functional and anatomic outcomes', 'mean number of injections', 'central retinal thickness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0311438', 'cui_str': 'Exudative (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}]",,0.0767897,"Outcomes were similar between the 2- and 4-week groups.
","[{'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Ohji', 'Affiliation': 'Department of Ophthalmology, Shiga University of Medical Science, Seta Tsukinowa-cho, Otsu, Shiga, Japan. eye.ohji@gmail.com.'}, {'ForeName': 'Kanji', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Ophthalmology, Kansai Medical University, School of Medicine, Hirakata City, Osaka, Japan.'}, {'ForeName': 'Annabelle A', 'Initials': 'AA', 'LastName': 'Okada', 'Affiliation': 'Department of Ophthalmology, Kyorin University, School of Medicine, Mitaka-shi, Tokyo, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Bayer Yakuhin Ltd, Marunouchi 1-chome, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Bayer Yakuhin Ltd, Umeda 2-chome, Kita-ku, Osaka, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Terano', 'Affiliation': 'Bayer Yakuhin Ltd, Umeda 2-chome, Kita-ku, Osaka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-020-01236-x']
149,31479383,An N-of-1 Randomized Controlled Trial of Interventions for Children With Inconsistent Speech Sound Errors.,"Purpose The aim of this study was to test the hypothesis that children with inconsistent speech errors would respond differentially to 1 of 3 specific interventions depending on their primary underlying impairment: Children with deficient motor planning were expected to respond best to an auditory-motor integration (AMI) intervention, and children with deficient phonological planning were expected to respond best to a phonological memory and planning (PMP) intervention. Method Twelve participants were diagnosed with a motor planning ( n  = 7) or phonological planning ( n  = 5) deficit based on a comprehensive assessment, which included the Syllable Repetition Task as an important source of diagnostic evidence. An N-of-1 randomized controlled trial was used. Each child experienced all 3 interventions: AMI, PMP, and control (CTL); however, these interventions were randomly allocated to sessions within weeks (3 sessions per week × 6 weeks for 18 sessions). The AMI intervention procedures targeted knowledge of the acoustic-phonetic target and integration of auditory and somatosensory feedback during speech practice. The PMP intervention procedures targeted segmenting and recompiling the phonological plan for each word. The CTL intervention was standard drill practice. The child was taught 5 pseudowords in a meaningful context in each intervention condition. Results Same-day (SD) probes assessed transfer from taught pseudowords to untaught real words, and next-day (ND) probes assessed retention of that learning. Nonparametric resampling tests with pooling of  p  values across children with the same diagnosis were used to assess the results. Pooled  p  values indicated a significant benefit of AMI over PMP for the group with a motor planning deficit ( p  = 2.01E-04 for SD probes and 2.97E-03 for ND probes) and a significant benefit of PMP over AMI for the group with a phonological planning deficit ( p  = 1.22E-02 for SD probes and 1.32E-02 for ND probes). Response to the CTL intervention was variable within groups. Conclusion In this study, the child's underlying psycholinguistic deficit helped to predict response to intervention.",2019,Pooled p values indicated a significant benefit of AMI over PMP for the group with a motor planning deficit (p = 2.01E-04 for SD probes and 2.97E-03 for ND probes) and a significant benefit of PMP over AMI for the group with a phonological planning deficit (p = 1.22E-02 for SD probes and 1.32E-02 for ND probes).,"['children with inconsistent speech errors', 'Method Twelve participants were diagnosed with a motor planning (n = 7) or phonological planning (n = 5) deficit based on a comprehensive assessment, which included the Syllable Repetition Task as an important source of diagnostic evidence', 'Children']","['auditory-motor integration (AMI) intervention, and children with deficient phonological planning were expected to respond best to a phonological memory and planning (PMP) intervention', 'CTL intervention']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442809', 'cui_str': 'Inconsistent (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",[],,0.0461714,Pooled p values indicated a significant benefit of AMI over PMP for the group with a motor planning deficit (p = 2.01E-04 for SD probes and 2.97E-03 for ND probes) and a significant benefit of PMP over AMI for the group with a phonological planning deficit (p = 1.22E-02 for SD probes and 1.32E-02 for ND probes).,"[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Rvachew', 'Affiliation': 'School of Communication Sciences and Disorders, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Matthews', 'Affiliation': 'School of Communication Sciences and Disorders, McGill University, Montréal, Québec, Canada.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-S-18-0288']
150,32307641,Cost-effectiveness of fine-needle aspiration cytology (FNAC) and watchful observation for incidental thyroid nodules.,"OBJECTIVES


A trial-based comparison of the use of resources, costs and health utility outcomes of fine-needle aspiration cytology (FNAC), and watchful observation for incidental small (< 2 cm) thyroid nodules was performed using data from the randomized controlled trial (RCT).
METHODS


Using data from 314 patients, healthcare-related use of resources, costs, health utility, and quality-adjusted life years (QALYs) were estimated at 12 months after first presentation of incidental thyroid nodule(s) on an intention-to-treat basis with adjustment for covariates. Uncertainty about the incremental cost-effectiveness ratio for FNAC versus watchful management at 12 months of follow-up was incorporated using bootstrapping. Multiple imputation methods were used to deal with missing data.
RESULTS


FNAC management was associated with greater use of healthcare resources and mean direct healthcare costs per patient (US$542.47 vs US$411.55). Lower mean 12-month QALYs per patient in FNAC was observed in comparison to watchful observation (0.752 versus 0.758). The probability that FNAC management was cost-effective compared with watchful management at a willingness-to-pay threshold of US50,000 per QALY gained was 26.5%.
CONCLUSION


Based on 12-month data from RCT, watchful observation appeared cost-saving compared to FNAC in patients with incidental thyroid nodules that have a low-suspicion sonographic pattern and measure between 1.0 and 2.0 cm from healthcare provider perspective. CLINICALTRIALS.
GOV IDENTIFIER


NCT02398721.",2020,"RESULTS


FNAC management was associated with greater use of healthcare resources and mean direct healthcare costs per patient (US$542.47 vs US$411.55).","['incidental thyroid nodules', 'Using data from 314 patients, healthcare-related use of resources, costs, health utility, and quality-adjusted life years (QALYs) were estimated at 12\xa0months after first presentation of incidental thyroid nodule(s) on an intention-to-treat basis with adjustment for covariates', 'incidental small (<\u20092\xa0cm) thyroid nodules', 'patients with incidental thyroid nodules']","['FNAC', 'fine-needle aspiration cytology (FNAC) and watchful observation', 'fine-needle aspiration cytology (FNAC', 'RCT']","['healthcare resources and mean direct healthcare costs', 'cost-saving']","[{'cui': 'C0444507', 'cui_str': 'Incidental'}, {'cui': 'C0040137', 'cui_str': 'Thyroid nodule'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439629', 'cui_str': 'First presentation'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]","[{'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}]",314.0,0.0587889,"RESULTS


FNAC management was associated with greater use of healthcare resources and mean direct healthcare costs per patient (US$542.47 vs US$411.55).","[{'ForeName': 'C K H', 'Initials': 'CKH', 'LastName': 'Wong', 'Affiliation': 'Department of Family Medicine and Primary Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China. carlosho@hku.hk.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Surgery, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong SAR, China.'}, {'ForeName': 'B H H', 'Initials': 'BHH', 'LastName': 'Lang', 'Affiliation': 'Department of Surgery, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong SAR, China.'}]",Journal of endocrinological investigation,['10.1007/s40618-020-01254-0']
151,31455577,Can the Perceived Difficulty of a Task Enhance Trainee Performance?,"BACKGROUND


Human understanding of how to efficiently train learners in procedural skills is imperfect. The concept of self-efficacy - confidence in one's ability to successfully complete a task - may be useful to learners. Theories of motivation and instructional design suggest there are specific targets for improving learner success. We aimed to study the effects of induced conceptions of ability on motor learning using both undergraduate and medical students.
METHODS


Forty undergraduate and medical students underwent a 15-minute training session teaching the basics of colonoscopy on a low-cost, moderate fidelity colonoscopy simulation model. Students were then tasked to intubate the cecum of a similarly constructed colonoscopy model with a real colonoscope. Before each task, participants were given a note which either read ""90% of your peers completed the task in less than 5 minutes"" (positive [+] comparison group) or ""10% of your peers completed the task in less than 5 minutes"" (negative [-] comparison group). Immediately after receiving the note, participants were then asked to complete a self-efficacy questionnaire, ranking their confidence on a scale from 0 to 10 for successfully completing the task. A NASA TLX was collected to understand the students' mental effort with the task. Participants then underwent stratified randomization into 2 crossover groups (G1 = + note, then - note; G2 = - note, then + note) and again performed the colonoscopy task. Following the session completion, all students had received both notes and crossed over to complete both tasks. Time spent on both tasks and task completion (reaching the cecum) was the measured outcomes.
RESULTS


Self-efficacy (confidence) levels were significantly higher in the positive note condition for both comparison groups in (p < 0.05). However, task completion rates were higher in the negative note group in Task 1 (p < 0.05) and the same in Task 2 (p = 0.6). Time spent by participants in each task was longer in the negative note groups in both tasks (p = 0.06 in Task 1; p = 0.07 in Task 2). No difference was found between both groups in the mental effort after each task (Table 1).
CONCLUSIONS


This prospective, cross-over study suggests that performance expectancies can be influenced by preinduced conceptions. Performance was enhanced in Task 1 when participants were given a relatively ""low success rate prediction."" This may be due to an enhanced focus that led to increased performance-while participants who were given the prediction of a ""higher success rate"" were more confident but performed less well. The crossover groups for Task 2 performed in a similar manner despite different confidence levels. This study supports the idea that self-efficacy expectations are relevant for trainee education and performance.",2019,Time spent by participants in each task was longer in the negative note groups in both tasks (p = 0.06 in Task 1; p = 0.07 in Task 2).,"['Forty undergraduate and medical students', 'undergraduate and medical students']","['read ""90% of your peers completed the task in less than 5 minutes"" (positive [+] comparison group) or ""10% of your peers completed the task in less than 5 minutes"" (negative [-] comparison group', '15-minute training session teaching the basics of colonoscopy on a low-cost, moderate fidelity colonoscopy simulation model']","['Time spent', 'Self-efficacy (confidence) levels', 'task completion rates', 'Performance', 'Time spent on both tasks and task completion (reaching the cecum']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0007531', 'cui_str': 'Cecum'}]",,0.040977,Time spent by participants in each task was longer in the negative note groups in both tasks (p = 0.06 in Task 1; p = 0.07 in Task 2).,"[{'ForeName': 'Yazan', 'Initials': 'Y', 'LastName': 'Aljamal', 'Affiliation': 'Mayo Clinic Multidisciplinary Simulation Center, Mayo Clinic College of Medicine and Science, Rochester, Minnesota; Department of General Surgery, Mayo Clinic, Rochester, Minnesota. Electronic address: aljamal.yazan@mayo.edu.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Prabhakar', 'Affiliation': 'Department of General Surgery, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Humza', 'Initials': 'H', 'LastName': 'Saleem', 'Affiliation': 'Department of General Surgery, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Farley', 'Affiliation': 'Department of General Surgery, Mayo Clinic, Rochester, Minnesota.'}]",Journal of surgical education,['10.1016/j.jsurg.2019.08.005']
152,31479287,Dual Tasking Influences Cough Sensorimotor Outcomes in Healthy Young Adults.,"Purpose Reflex cough is an essential airway protective mechanism that often occurs in the context of divided attention. The effect of divided attention on measures of reflexive cough airflow and sensitivity remains unknown. We present findings from a study testing the effects of divided attention (via a dual-task paradigm) on measures of reflex cough in healthy young adults. Method Volunteers ( N  = 20, age = 20-40 years) underwent 4 blocks of capsaicin-induced cough challenges. Within each block, capsaicin ranging from 0 to 200 μM was presented in a randomized order. Two blocks consisted of cough testing only (single task). During the other 2 blocks, participants counted tones while simultaneously undergoing cough testing (dual task). Measures of cough motor response, self-reported urge-to-cough, cough frequency, and cough airflow were collected. Results Participants coughed more in the single-task condition compared to the dual-task condition ( p  ≤ .001). Participants' urge-to-cough ratings were lower in the dual-task condition ( x̅  = 2, ""slight"") compared to the single-task condition ( x̅  = 3, ""moderate"";  p  = .007). Participants' cough reflex sensitivity thresholds were significantly increased in the dual-task condition ( p  = .002). Cough peak expiratory flow rates did not change between the 2 conditions ( p  = .34). Conclusions Somatosensation of tussive stimuli changes during dual tasking. Abnormal cortical resource allocation may be a mechanism involved in silent aspiration.",2019,Results Participants coughed more in the single-task condition compared to the dual-task condition (p ≤ .001).,"['healthy young adults', 'Method Volunteers (N = 20, age = 20-40 years) underwent 4 blocks of', 'Healthy Young Adults']","['capsaicin', 'capsaicin-induced cough challenges', 'Dual Tasking', 'divided attention (via a dual-task paradigm']","['cough motor response, self-reported urge-to-cough, cough frequency, and cough airflow', 'reflex cough', 'Cough peak expiratory flow rates', ""Participants' urge-to-cough ratings"", 'cough reflex sensitivity thresholds']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C1285623', 'cui_str': 'Motor response'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C1542834', 'cui_str': 'Peak expiratory flow rate (observable entity)'}, {'cui': 'C0232051', 'cui_str': 'Cough reflex (observable entity)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}]",,0.0241401,Results Participants coughed more in the single-task condition compared to the dual-task condition (p ≤ .001).,"[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Perry', 'Affiliation': 'Laboratory for the Study of Upper Airway Dysfunction, Teachers College, Columbia University, New York, NY.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Troche', 'Affiliation': 'Laboratory for the Study of Upper Airway Dysfunction, Teachers College, Columbia University, New York, NY.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-H-19-0122']
153,31590179,Influence of combined treatment with naltrexone and memantine on alcohol drinking behaviors: a phase II randomized crossover trial.,"Glutamate and opioid systems play important roles in alcohol drinking behaviors. We examined if combined treatment with the NMDA antagonist memantine and the opioid antagonist naltrexone, when compared with naltrexone alone, would have a greater influence on alcohol drinking behaviors. Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism, participated in a randomized, double-blind, crossover trial, including two 6-8 days treatment periods, separated by a 6-day washout, and 3 alcohol drinking paradigm (ADP) sessions. After the first baseline (BAS) ADP1 session, participants were randomized to receive either naltrexone (NTX; 50 mg/day) + placebo memantine, or NTX (50 mg/day) + memantine (MEM; 20 mg/day), during the first treatment period, following which they completed ADP2. After a 6-day washout, participants were crossed over to the treatment they did not receive during the first treatment period, following which they completed ADP3. During each ADP, participants received a priming drink of alcohol followed by 3 1-hour, self-administration periods during which they had ad-lib access to 12 drinks. Individually, both NTX and NTX + MEM, when compared to BAS ADP1, significantly reduced the number of drinks consumed (p's < 0.001) and craving (p's < 0.001). When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004). Specifically, when NTX + MEM followed NTX alone, NTX + MEM resulted in a further reduction in drinking (mean: -1.94; 95% CI: -2.6, -0.8, p = 0.0005). However, when NTX alone followed NTX + MEM, NTX alone did not lead to further reduction in drinking (mean: 0.59; 95% CI: -0.67, 1.43, p = 0.47). Similar patterns were observed for alcohol craving; specifically, a significant reduction in craving was observed when NTX + MEM followed NTX alone (p = 0.009), but craving reduction was maintained when NTX + MEM was followed by NTX alone. Neither treatment condition significantly influenced alcohol-induced stimulation or sedation. Memantine (at a dose of 20 mg/day) enhances the efficacy of naltrexone (50 mg/day) in reducing alcohol drinking and craving among FHP drinkers with beneficial effects that appear to carryover after discontinuation of memantine treatment.",2020,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","['Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism']","['Memantine', 'naltrexone', 'NTX\u2009+\u2009MEM vs. NTX', 'NMDA antagonist memantine', 'NTX', 'alcohol drinking paradigm (ADP) sessions', 'naltrexone (NTX; 50\u2009mg/day)\u2009+\u2009placebo memantine, or NTX (50\u2009mg/day)\u2009+\u2009memantine (MEM', 'opioid antagonist naltrexone', 'naltrexone and memantine', 'priming drink of alcohol']","['craving', 'alcohol craving', 'alcohol drinking behaviors', 'craving reduction', 'number of drinks consumed', 'alcohol drinking and craving', 'alcohol-induced stimulation or sedation']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0559555', 'cui_str': 'FH - Alcoholism'}]","[{'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1979923', 'cui_str': 'Micro-Electro-Mechanical Systems'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0565662', 'cui_str': 'Finding relating to alcohol drinking behavior'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",12.0,0.0285429,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","[{'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Krishnan-Sarin', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA. suchitra.krishnan-sarin@yale.edu.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Franco', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Cavallo', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Tetrault', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0536-z']
154,31634898,A multipredictor model to predict the conversion of mild cognitive impairment to Alzheimer's disease by using a predictive nomogram.,"Predicting the probability of converting from mild cognitive impairment (MCI) to Alzheimer's disease (AD) is still a challenging task. This study aims at providing a personalized MCI-to-AD conversion estimation by using a multipredictor nomogram that integrates neuroimaging features, cerebrospinal fluid (CSF) biomarker, and clinical assessments. To do so, 290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI. All subjects were randomly divided into a primary and validation cohort. Radiomics signature (Rad-sig) was obtained based on 17 cerebral cortex features selected by using Least Absolute Shrinkage and Selection Operator (LASSO) algorithm. Clinical factors and amyloid-beta peptide (Aβ) concentration were selected by using Spearman correlation between the converted and not-converted patients. Then, a nomogram that combines image features, clinical factor, and Aβ concentration was constructed and validated. Furthermore, we explored the associations between various predictors from the macro- to the microperspective by assessing gene expression patterns. Our results showed that the multipredictor nomogram (C-index 0.978 and 0.956 in both cohorts, respectively) outperformed the nomogram using either Rad-sig or Aβ concentration as individual predictors. Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways. Our study may have a clinical impact as a powerful predictive tool for predicting the conversion probability of MCI and providing associations between cognitive impairment, structural changes, Aβ levels, and underlying biological patterns from the macro- to the microperspective.",2020,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[""290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI""]",[],"['neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways', 'Clinical factors and amyloid-beta peptide (Aβ) concentration']","[{'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007776', 'cui_str': 'Cortical Plate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0078939', 'cui_str': ""Alzheimer's ABP""}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0173736,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[{'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yubo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Liaojun', 'Initials': 'L', 'LastName': 'Pang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, School of Life Sciences and Technology, Xi'an Jiaotong University, Xi'an, 710049, P. R. China.""}, {'ForeName': 'Liyu', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China. huangly@mail.xidian.edu.cn.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0551-0']
155,31514201,The effect of methylphenidate on social cognition and oxytocin in children with attention deficit hyperactivity disorder.,"The current study aimed to explore the possible effect of stimulants on oxytocin (OT), a neuropeptide which regulates social behavior, as a mediator of the pro-social effect of methylphenidate (MPH) in children with attention deficit hyperactivity disorder (ADHD) compared to healthy controls (HCs). Utilizing a double-blind placebo-controlled design, we compared the performance of 50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks and examined the effect of a single dose of MPH/placebo on ToM and salivary OT levels in children with ADHD at baseline and following an interpersonal interaction. Children with ADHD displayed significantly poorer ToM performance; however, following MPH administration, their performance normalized and differences between children with ADHD and HC were no longer found. Salivary OT levels at baseline did not differ between children with ADHD and HCs. However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD. Administration of MPH attenuated this difference such that after parent-child interaction differences in OT levels between children with ADHD and HC were no longer found. In the ADHD group, OT levels decreased from administration of placebo to the parent-child interaction. However, the administration of MPH to children with ADHD was associated with an increase in OT levels after the parent-child interaction. We conclude that OT might play a role as a mediator of social deficits in children with ADHD and that the reactivity of the OT system to social interaction in children with ADHD might be impaired. Stimulants may improve ToM and social functions in children with ADHD via its impact on the OT system. PRS: OT and Social Cognition in Children with ADHD: Impact of MPH.",2020,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","['Children with ADHD', 'children with attention deficit hyperactivity disorder (ADHD', '50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks', 'children with ADHD at baseline and following an interpersonal interaction', 'children with attention deficit hyperactivity disorder', 'children with ADHD']","['methylphenidate', 'HC', 'MPH', 'MPH/placebo', 'oxytocin (OT', 'placebo', 'methylphenidate (MPH']","['ToM and social functions', 'poorer ToM performance', 'Salivary OT levels', 'social cognition and oxytocin', 'ToM and salivary OT levels', 'OT levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",50.0,0.04804,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","[{'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Levi-Shachar', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Hila Z', 'Initials': 'HZ', 'LastName': 'Gvirts', 'Affiliation': 'Department of Behavioral Sciences and Psychology, Ariel University, Ariel, Israel.'}, {'ForeName': 'Yiftach', 'Initials': 'Y', 'LastName': 'Goldwin', 'Affiliation': 'Shalvata Mental Health Center, Hod-Hasharon, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Bloch', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Shamay-Tsoory', 'Affiliation': 'Department of Psychology, Haifa University, Haifa, Israel.'}, {'ForeName': 'Orna', 'Initials': 'O', 'LastName': 'Zagoory-Sharon', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Feldman', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Maoz', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. hagaima@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0522-5']
156,31771797,"Ten-year Mortality, Disease Progression, and Treatment-related Side Effects in Men with Localised Prostate Cancer from the ProtecT Randomised Controlled Trial According to Treatment Received.","BACKGROUND


The ProtecT trial reported intention-to-treat analysis of men with localised prostate cancer (PCa) randomly allocated to active monitoring (AM), radical prostatectomy, and external beam radiotherapy.
OBJECTIVE


To determine report outcomes according to treatment received in men in randomised and treatment choice cohorts.
DESIGN, SETTING, AND PARTICIPANTS


This study focuses on secondary care. Men with clinically localised prostate cancer at one of nine UK centres were invited to participate in the treatment trial comparing AM, radical prostatectomy, and radiotherapy.
INTERVENTION


Two cohorts included 1643 men who agreed to be randomised; 997 declined randomisation and chose treatment.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Health-related quality of life impacts on urinary, bowel, and sexual function were assessed using patient-reported outcome measures. Analysis was carried out based on treatment received for each cohort and on pooled estimates using meta-analysis. Differences were estimated with adjustment for known prognostic factors using propensity scores.
RESULTS AND LIMITATIONS


According to treatment received, more men receiving AM died of PCa (AM 1.85%, surgery 0.67%, radiotherapy 0.73%), whilst this difference remained consistent with chance in the randomised cohort (p=0.08); stronger evidence was found in the exploratory analyses (randomised plus choice cohort) when AM was compared with the combined radical treatment group (p=0.003). There was also strong evidence that metastasis (AM 5.6%, surgery 2.4%, radiotherapy 2.7%) and disease progression (AM 20.35%, surgery 5.87%, radiotherapy 6.62%) were more common in the AM group. Compared with AM, there were higher risks of sexual dysfunction (95% at 6mo) and urinary incontinence (55% at 6mo) after surgery, and of sexual dysfunction (88% at 6mo) and bowel dysfunction (5% at 6mo) after radiotherapy. The key limitations are the potential for bias when comparing groups defined by treatment received and outdating of the interventions being evaluated during the lengthy follow-up required in trials of screen-detected PCa.
CONCLUSIONS


Analyses according to treatment received showed increased rates of disease-related events and lower rates of patient-reported harms in men managed by AM compared with men managed by radical treatment, and stronger evidence of greater PCa mortality in the AM group.
PATIENT SUMMARY


More than 90 out of every 100 men with localised prostate cancer do not die of prostate cancer within 10yr, irrespective of whether treatment is by means of monitoring, surgery, or radiotherapy. Side effects on sexual and bladder function are much better after active monitoring, but the risks of spreading of prostate cancer are more common.",2020,"According to treatment received, more men receiving AM died of PCa (AM 1.85%, surgery 0.67%, radiotherapy 0.73%), whilst this difference remained consistent with chance in the randomised cohort (p=0.08); stronger evidence was found in the exploratory analyses (randomised plus choice cohort) when AM was compared with the combined radical treatment group (p=0.003).","['men with localised prostate cancer', '100 men with low or intermediate risk localised prostate cancer', 'Men with Localised Prostate Cancer', 'Two cohorts included 1643 men who agreed to be randomised and 997 who declined randomisation and chose treatment', 'Men with clinically localised prostate cancer at one of nine UK centres']","['active monitoring (AM), radical prostatectomy, and external beam radiotherapy', 'AM, radical prostatectomy, and radiotherapy']","['disease progression', 'urinary incontinence', 'PCa mortality', 'sexual dysfunction', 'mortality, metastasis and progression and health-related quality of life impacts on urinary, bowel, and sexual function', 'bowel dysfunction', 'rates of disease-related events', 'higher risks of sexual dysfunction', 'sexual and bladder function']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1531698', 'cui_str': 'Active monitoring'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure (procedure)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder (disorder)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C2004461', 'cui_str': 'Bowel dysfunction (disorder)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0232840', 'cui_str': 'Bladder function (observable entity)'}]",1643.0,0.143431,"According to treatment received, more men receiving AM died of PCa (AM 1.85%, surgery 0.67%, radiotherapy 0.73%), whilst this difference remained consistent with chance in the randomised cohort (p=0.08); stronger evidence was found in the exploratory analyses (randomised plus choice cohort) when AM was compared with the combined radical treatment group (p=0.003).","[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Neal', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK. Electronic address: David.Neal@nds.ox.ac.uk.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eleanor I', 'Initials': 'EI', 'LastName': 'Walsh', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Mason', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bryant', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Bollina', 'Affiliation': 'Department of Urology & Surgery, Western General Hospital, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Catto', 'Affiliation': 'Academic Urology Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Doherty', 'Affiliation': 'Department of Urology, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillatt', 'Affiliation': 'Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gnanapragasam', 'Affiliation': 'Academic Urology Group, Department of Surgery & Cambridge Urology Translational Research and Clinical Trials, Cambridge Biomedical Campus, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Holding', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Hughes', 'Affiliation': 'Department of Urology, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Kockelbergh', 'Affiliation': 'Department of Urology, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Kynaston', 'Affiliation': 'Division of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Oxley', 'Affiliation': 'Department of Cellular Pathology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Paul', 'Affiliation': 'Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Paez', 'Affiliation': 'Department of Urology, Freeman Hospital, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Rosario', 'Affiliation': 'Department of Urology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Rowe', 'Affiliation': 'Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'Division of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Doug G', 'Initials': 'DG', 'LastName': 'Altman', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Freddie C', 'Initials': 'FC', 'LastName': 'Hamdy', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2019.10.030']
157,31486777,Magnetic seizure therapy (MST) for major depressive disorder.,"Electroconvulsive therapy (ECT) is effective for major depressive disorder (MDD) but its effects on memory limit its widespread use. Magnetic seizure therapy (MST) is a potential alternative to ECT that may not adversely affect memory. In the current trial, consecutive patients with MDD consented to receive MST applied over the prefrontal cortex according to an open-label protocol. Depressive symptoms and cognition were assessed prior to, during and at the end of treatment. Patients were treated two to three times per week with high-frequency MST (i.e., 100 Hz) (N = 24), medium frequency MST (i.e., 60 or 50 Hz) (N = 26), or low-frequency MST (i.e., 25 Hz MST) (N = 36) using 100% stimulator output. One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n = 17) or received a maximum of 24 sessions (n = 30). High-frequency (100 Hz) MST produced the highest remission rate (33.3%). Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance. Under open conditions, MST led to clinically meaningful reduction in depressive symptoms in patients with MDD and produced minimal cognitive impairment. Future studies should compare MST and ECT under double-blind randomized condition.",2020,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","['consecutive patients with MDD consented to receive', 'major depressive disorder', 'One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n\u2009=\u200917) or received a maximum of 24 sessions (n\u2009=\u200930']","['Magnetic seizure therapy (MST', 'Electroconvulsive therapy (ECT', 'MST']","['depressive symptoms', 'High-frequency', 'Depressive symptoms and cognition', 'minimal cognitive impairment', 'highest remission rate', 'brief visuospatial memory task performance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1291708', 'cui_str': 'Minimal cognitive impairment'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",140.0,0.0334955,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","[{'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Jeff.Daskalakis@camh.ca.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Dimitrova', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'McClintock', 'Affiliation': 'Neurocognitive Research Laboratory, Department of Psychiatry, University of Texas Southwestern Medical Center, and Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yinming', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Voineskos', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Goldbloom', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Albert H C', 'Initials': 'AHC', 'LastName': 'Wong', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Knyahnytska', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Toronto General Hospital, University Health Network, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Commercial Rd Melbourne, VIC, Australia.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0515-4']
158,31165663,Effect of Ticagrelor Versus Clopidogrel on Aortic Stiffness in Patients With Coronary Artery Disease.,"Background We compared the acute and midterm effect of ticagrelor versus clopidogrel on aortic stiffness. Methods and Results We studied 117 patients in a randomized, assessor-blinded, parallel-group trial. The acute effect of ticagrelor was studied in 58 patients randomized (1:1) to receive a loading dose of clopidogrel (600 mg) or ticagrelor (180 mg). Carotid-femoral pulse wave velocity (cf PWV ) was measured before, 3, and 24 hours after the loading dose. The midterm effect (30-day treatment period) was studied in 59 subjects who underwent percutaneous coronary intervention and were randomized to either clopidogrel (75 mg, OD) or ticagrelor (90 mg BID). cf PWV was measured before and at 30 days of treatment. Circulating markers of inflammation and endothelial function were measured at all study points. Repeated-measures analysis showed a significant main effect for treatment ( P=0.03), with the ticagrelor showing a reduction in cf PWV after treatment. cf PWV at 24 hours was significantly lower in the ticagrelor group compared with the clopidogrel group ( P=0.017) (maximal response reduction by 0.42±0.26 m/s). At 30 days, cf PWV decreased in the ticagrelor group, whereas there was no change with clopidogrel (-0.43±0.57 versus 0.12±0.14 m/s, P=0.004). There were no significant changes in both the acute and midterm study period in the pro-inflammatory and endothelial function parameters. Conclusions URL : https://www.clinicaltrials.gov . Unique identifier: NCT02071212. Ticagrelor decreases cf PWV for 24 hours after the loading dose and at 1 month post-percutaneous coronary intervention compared with clopidogrel. Considering that aortic stiffness is an independent predictor of cardiovascular events, this finding may have clinical implications regarding the beneficial effect of ticagrelor. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT02071212.",2019,There were no significant changes in both the acute and midterm study period in the pro-inflammatory and endothelial function parameters.,"['58 patients randomized (1:1', 'Patients With Coronary Artery Disease', '117 patients', '59 subjects who underwent percutaneous coronary intervention']","['Ticagrelor Versus Clopidogrel', 'ticagrelor', 'clopidogrel', 'Ticagrelor']","['Circulating markers of inflammation and endothelial function', 'Carotid-femoral pulse wave velocity (cf PWV ', 'cf PWV', 'pro-inflammatory and endothelial function parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",58.0,0.157143,There were no significant changes in both the acute and midterm study period in the pro-inflammatory and endothelial function parameters.,"[{'ForeName': 'Charalambos', 'Initials': 'C', 'LastName': 'Vlachopoulos', 'Affiliation': '1 First Department of Cardiology Hippokration Hospital Athens Medical School Athens Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Georgakopoulos', 'Affiliation': '1 First Department of Cardiology Hippokration Hospital Athens Medical School Athens Greece.'}, {'ForeName': 'Panagiota', 'Initials': 'P', 'LastName': 'Pietri', 'Affiliation': '2 Hypertension Unit Athens Heart Center Athens Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Ioakeimidis', 'Affiliation': '1 First Department of Cardiology Hippokration Hospital Athens Medical School Athens Greece.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koutouzis', 'Affiliation': '3 Second Department of Cardiology Red Cross General Hospital Athens Greece.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vaina', 'Affiliation': '1 First Department of Cardiology Hippokration Hospital Athens Medical School Athens Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Aznaouridis', 'Affiliation': '1 First Department of Cardiology Hippokration Hospital Athens Medical School Athens Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Toutouzas', 'Affiliation': '1 First Department of Cardiology Hippokration Hospital Athens Medical School Athens Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Latsios', 'Affiliation': '1 First Department of Cardiology Hippokration Hospital Athens Medical School Athens Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Terentes-Printzios', 'Affiliation': '1 First Department of Cardiology Hippokration Hospital Athens Medical School Athens Greece.'}, {'ForeName': 'Aggeliki', 'Initials': 'A', 'LastName': 'Rigatou', 'Affiliation': '3 Second Department of Cardiology Red Cross General Hospital Athens Greece.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Tousoulis', 'Affiliation': '1 First Department of Cardiology Hippokration Hospital Athens Medical School Athens Greece.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.012521']
159,31190609,Statins Reduce Epicardial Adipose Tissue Attenuation Independent of Lipid Lowering: A Potential Pleiotropic Effect.,"Background High epicardial adipose tissue (EAT) attenuation (Hounsfield units [ HUs] ) on computed tomography is considered a marker of inflammation and is associated with an increased risk of cardiovascular events. Statins reduce the volume of EAT , but it is unknown whether they affect EAT HUs . Methods and Results We reviewed the chest computed tomographic scans of 420 postmenopausal women randomized to either 80 mg of atorvastatin or 40 mg of pravastatin daily and rescanned after 1 year to measure change in coronary artery calcium score. EAT HUs were measured near the proximal right coronary artery and remote from any area of coronary artery calcium. Computed tomographic images were also queried for subcutaneous adipose tissue (SubQ) attenuation ( HUs ) change over time. The mean patients' age was 65±6 years. The baseline EAT HU value was higher than the SubQ HU value (-89.4±24.0 HU versus -123.3±30.4 HU ; P<0.001). The EAT HU value decreased significantly in the entire cohort (-5.4±29.7 HU [-6% change]; P<0.001), but equally in the patients given atorvastatin and pravastatin (-6.35+31 HU and -4.55+28 HU ; P=0.55). EAT HU change was not associated with change in total cholesterol, low-density lipoprotein cholesterol, coronary artery calcium, and EAT volume (all P=not significant). Change in high-density lipoprotein cholesterol was marginally associated with EAT HU change ( P=0.07). Statin treatment did not induce a change in SubQ HUs . Conclusions Statins induced a decrease in EAT HUs over time, independent of intensity of low-density lipoprotein cholesterol lowering. The positive effect on EAT and the neutral effect on SubQ suggest that statins induced a decrease in metabolic activity in EAT by reduction in cellularity, vascularity, or inflammation. The clinical significance of the observed change in EAT HUs remains to be demonstrated.",2019,"The EAT HU value decreased significantly in the entire cohort (-5.4±29.7 HU [-6% change]; P<0.001), but equally in the patients given atorvastatin and pravastatin (-6.35+31 HU and -4.55+28 HU ; P=0.55).","[""mean patients' age was 65±6\xa0years"", '420 postmenopausal women']","['atorvastatin and pravastatin', 'EAT', ' High epicardial adipose tissue (EAT) attenuation (Hounsfield units [ HUs] ', '80\xa0mg of atorvastatin or 40\xa0mg of pravastatin']","['cellularity, vascularity, or inflammation', 'EAT HUs over time, independent of intensity of low-density lipoprotein cholesterol lowering', 'total cholesterol, low-density lipoprotein cholesterol, coronary artery calcium, and EAT volume', 'high-density lipoprotein cholesterol', 'SubQ HUs ', 'volume of EAT', 'subcutaneous adipose tissue (SubQ) attenuation ( HUs ) change over time', 'baseline EAT HU value', 'metabolic activity in EAT', 'coronary artery calcium score', 'EAT HU value']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332291', 'cui_str': 'Independent of (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3484386', 'cui_str': 'Coronary artery calcium score'}]",420.0,0.0884402,"The EAT HU value decreased significantly in the entire cohort (-5.4±29.7 HU [-6% change]; P<0.001), but equally in the patients given atorvastatin and pravastatin (-6.35+31 HU and -4.55+28 HU ; P=0.55).","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Raggi', 'Affiliation': '1 Mazankowski Alberta Heart Institute and Department of Medicine University of Alberta Edmonton Alberta Canada.'}, {'ForeName': 'Varuna', 'Initials': 'V', 'LastName': 'Gadiyaram', 'Affiliation': '2 Division of Cardiology Emory University Atlanta GA.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': '3 Department of Biostatistics and Bioinformatics Emory University Atlanta GA.'}, {'ForeName': 'Zhengjia', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': '3 Department of Biostatistics and Bioinformatics Emory University Atlanta GA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Lopaschuk', 'Affiliation': '4 Department of Pediatrics University of Alberta Edmonton Alberta Canada.'}, {'ForeName': 'Arthur E', 'Initials': 'AE', 'LastName': 'Stillman', 'Affiliation': '1 Mazankowski Alberta Heart Institute and Department of Medicine University of Alberta Edmonton Alberta Canada.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.013104']
160,31215299,Efficacy of Long-Term Remote Ischemic Conditioning on Vascular and Neuronal Function in Type 2 Diabetes Patients With Peripheral Arterial Disease.,"Background Peripheral artery disease is a major socioeconomic challenge in the diabetes mellitus community and non-surgical treatment options are limited. As remote ischemic conditioning ( RIC ) improves vascular function and attenuates ischemia-induced tissue damage, we investigated the efficacy of RIC on vascular and neuronal function in type 2 diabetes mellitus patients with peripheral artery disease. Methods and Results We enrolled 36 type 2 diabetes mellitus patients with moderately reduced toe pressure (40-70 mm Hg) in a randomized sham-controlled double-masked trial. Patients were allocated to 12 weeks once daily upper arm cuff-based treatment of either RIC treatment (4 cycles of 5-minute ischemia followed by 5-minute reperfusion) or similar sham-device treatment. Primary outcome was transcutaneous tissue oxygen tension of the instep of the feet. Secondary outcomes were aortic pulse wave velocity, toe pressure and toe-brachial index. Tertiary outcomes were markers of peripheral and autonomic nerve function. We enrolled 36 patients (83% men). Patients had a mean ( SD ) age of 70.7 years (6.8), diabetes mellitus duration of 18.4 years (8.3), HbA1c (gycated hemoglobin) of 59.7 mmol/mol (11.2). Eighty percent had peripheral symmetrical neuropathy. The mean difference in change of transcutaneous tissue oxygen tension from baseline between the RIC and sham-treated groups was -0.03 mm Hg ([95% CI -0.1; 0.04], P=0.438). RIC did not elicit any change in additional outcomes. Three patients experienced transient skin petechiae in the treated arm. Conclusions Long-term repeated remote ischemic conditioning treatment have no effect on tissue oxygenation, vascular or neuronal function in patients with type 2 diabetes mellitus and moderate peripheral artery disease. Clinical Trial Registration URL : http://www.ClinicalTrials.gov . Unique identifier: NCT02749942.",2019,"Conclusions Long-term repeated remote ischemic conditioning treatment have no effect on tissue oxygenation, vascular or neuronal function in patients with type 2 diabetes mellitus and moderate peripheral artery disease.","['type 2 diabetes mellitus patients with peripheral artery disease', 'patients with type 2 diabetes mellitus and moderate peripheral artery disease', 'Patients had a mean ( SD ) age of 70.7\xa0years (6.8), diabetes mellitus duration of 18.4\xa0years (8.3), HbA1c (gycated hemoglobin) of 59.7\xa0mmol/mol (11.2', 'We enrolled 36 patients (83% men', 'Type 2 Diabetes Patients With Peripheral Arterial Disease', '36 type 2 diabetes mellitus patients with moderately reduced toe pressure (40-70\xa0mm\xa0Hg', 'Hg ']","['remote ischemic conditioning ( RIC ', 'RIC', 'Long-Term Remote Ischemic Conditioning', 'RIC treatment (4 cycles of 5-minute ischemia followed by 5-minute reperfusion) or similar sham-device treatment']","['transcutaneous tissue oxygen tension of the instep of the feet', 'transcutaneous tissue oxygen tension', 'aortic pulse wave velocity, toe pressure and toe-brachial index', 'Vascular and Neuronal Function', 'transient skin petechiae', 'tissue oxygenation, vascular or neuronal function', 'markers of peripheral and autonomic nerve function', 'peripheral symmetrical neuropathy']","[{'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4517531', 'cui_str': '11.2 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0040357', 'cui_str': 'Toes'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial (procedure)'}, {'cui': 'C0230472', 'cui_str': 'Structure of medial arch of foot (instep)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0040357', 'cui_str': 'Toes'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C2116889', 'cui_str': 'Toe Brachial Index'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0031256', 'cui_str': 'Petechia (morphologic abnormality)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0206250', 'cui_str': 'Autonomic Nerves'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}]",36.0,0.44541,"Conclusions Long-term repeated remote ischemic conditioning treatment have no effect on tissue oxygenation, vascular or neuronal function in patients with type 2 diabetes mellitus and moderate peripheral artery disease.","[{'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Hansen', 'Affiliation': '1 Steno Diabetes Center Copenhagen Gentofte Denmark.'}, {'ForeName': 'Marit E', 'Initials': 'ME', 'LastName': 'Jørgensen', 'Affiliation': '1 Steno Diabetes Center Copenhagen Gentofte Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Fleischer', 'Affiliation': '3 Clinical Institute of Medicine Aarhus University Aarhus Denmark.'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': '4 Department of Cardiology Aarhus University Hospital Aarhus N Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': '1 Steno Diabetes Center Copenhagen Gentofte Denmark.'}]",Journal of the American Heart Association,['10.1161/JAHA.118.011779']
161,31237173,Impact of Evidence-Based Stroke Care on Patient Outcomes: A Multilevel Analysis of an International Study.,"Background The uptake of proven stroke treatments varies widely. We aimed to determine the association of evidence-based processes of care for acute ischemic stroke ( AIS ) and clinical outcome of patients who participated in the HEADPOST (Head Positioning in Acute Stroke Trial), a multicenter cluster crossover trial of lying flat versus sitting up, head positioning in acute stroke. Methods and Results Use of 8 AIS processes of care were considered: reperfusion therapy in eligible patients; acute stroke unit care; antihypertensive, antiplatelet, statin, and anticoagulation for atrial fibrillation; dysphagia assessment; and physiotherapist review. Hierarchical, mixed, logistic regression models were performed to determine associations with good outcome (modified Rankin Scale scores 0-2) at 90 days, adjusted for patient and hospital variables. Among 9485 patients with AIS, implementation of all processes of care in eligible patients, or ""defect-free"" care, was associated with improved outcome (odds ratio, 1.40; 95% CI, 1.18-1.65) and better survival (odds ratio, 2.23; 95% CI , 1.62-3.09). Defect-free stroke care was also significantly associated with excellent outcome (modified Rankin Scale score 0-1) (odds ratio, 1.22; 95% CI , 1.04-1.43). No hospital characteristic was independently predictive of outcome. Only 1445 (15%) of eligible patients with AIS received all processes of care, with significant regional variations in overall and individual rates. Conclusions Use of evidence-based care is associated with improved clinical outcome in AIS . Strategies are required to address regional variation in the use of proven AIS treatments. Clinical Trial Registration URL : https://www.clinicaltrials.gov . Unique Identifier: NCT02162017.",2019,"Defect-free stroke care was also significantly associated with excellent outcome (modified Rankin Scale score 0-1) (odds ratio, 1.22; 95% CI , 1.04-1.43).","['patients who participated in the HEADPOST (Head Positioning in Acute Stroke Trial', 'Patient Outcomes', 'eligible patients; acute stroke unit care', '9485 patients with AIS']","['Evidence-Based Stroke Care', 'reperfusion therapy']","['better survival', 'Defect-free stroke care']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0582540', 'cui_str': 'Head positions'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",9485.0,0.163752,"Defect-free stroke care was also significantly associated with excellent outcome (modified Rankin Scale score 0-1) (odds ratio, 1.22; 95% CI , 1.04-1.43).","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Muñoz Venturelli', 'Affiliation': '1 The George Institute for Global Health Faculty of Medicine University of New South Wales Sydney Australia.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': '1 The George Institute for Global Health Faculty of Medicine University of New South Wales Sydney Australia.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': '5 Nursing Research Institute St Vincents Health Australia (Sydney) and Australian Catholic University Sydney Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Watkins', 'Affiliation': '6 Faculty of Health and Wellbeing University of Central Lancashire Preston United Kingdom.'}, {'ForeName': 'Pablo M', 'Initials': 'PM', 'LastName': 'Lavados', 'Affiliation': '3 Servicio de Neurología Departamento de Neurología y Psiquiatría Alemana de Santiago Facultad de Medicina Clínica Alemana Universidad del Desarrollo Santiago Chile.'}, {'ForeName': 'Verónica V', 'Initials': 'VV', 'LastName': 'Olavarría', 'Affiliation': '3 Servicio de Neurología Departamento de Neurología y Psiquiatría Alemana de Santiago Facultad de Medicina Clínica Alemana Universidad del Desarrollo Santiago Chile.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Brunser', 'Affiliation': '3 Servicio de Neurología Departamento de Neurología y Psiquiatría Alemana de Santiago Facultad de Medicina Clínica Alemana Universidad del Desarrollo Santiago Chile.'}, {'ForeName': 'Octavio', 'Initials': 'O', 'LastName': 'Pontes-Neto', 'Affiliation': '9 Stroke Service Neurology Division Ribeirão Preto Medical School University of São Paulo Ribeirão Preto Brazil.'}, {'ForeName': 'Taiza E G', 'Initials': 'TEG', 'LastName': 'Santos', 'Affiliation': '9 Stroke Service Neurology Division Ribeirão Preto Medical School University of São Paulo Ribeirão Preto Brazil.'}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': '10 Department of Preventive Medicine and Public Health Faculty of Medicine Fukuoka University Fukuoka Japan.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': '1 The George Institute for Global Health Faculty of Medicine University of New South Wales Sydney Australia.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': '1 The George Institute for Global Health Faculty of Medicine University of New South Wales Sydney Australia.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': '1 The George Institute for Global Health Faculty of Medicine University of New South Wales Sydney Australia.'}, {'ForeName': 'Thompson', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': '11 Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Center University of Leicester United Kingdom.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': '1 The George Institute for Global Health Faculty of Medicine University of New South Wales Sydney Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.119.012640']
162,32066973,Effect of salt substitution on community-wide blood pressure and hypertension incidence.,"Replacement of regular salt with potassium-enriched substitutes reduces blood pressure in controlled situations, mainly among people with hypertension. We report on a population-wide implementation of this strategy in a stepped-wedge cluster randomized trial (NCT01960972). The regular salt in enrolled households was retrieved and replaced, free of charge, with a combination of 75% NaCl and 25% KCl. A total of 2,376 participants were enrolled in 6 villages in Tumbes, Peru. The fully adjusted intention-to-treat analysis showed an average reduction of 1.29 mm Hg (95% confidence interval (95% CI) (-2.17, -0.41)) in systolic and 0.76 mm Hg (95% CI (-1.39, -0.13)) in diastolic blood pressure. Among participants without hypertension at baseline, in the time- and cluster-adjusted model, the use of the salt substitute was associated with a 51% (95% CI (29%, 66%)) reduced risk of developing hypertension compared with the control group. In 24-h urine samples, there was no evidence of differences in sodium levels (mean difference 0.01; 95% CI (0.25, -0.23)), but potassium levels were higher at the end of the study than at baseline (mean difference 0.63; 95% CI (0.78, 0.47)). Our results support a case for implementing a pragmatic, population-wide, salt-substitution strategy for reducing blood pressure and hypertension incidence.",2020,"The fully adjusted intention-to-treat analysis showed an average reduction of 1.29 mm Hg (95% confidence interval (95% CI) (-2.17, -0.41)) in systolic and 0.76 mm Hg (95% CI (-1.39, -0.13)) in diastolic blood pressure.","['people with hypertension', '2,376 participants were enrolled in 6 villages in Tumbes, Peru']","['regular salt with potassium-enriched substitutes', 'salt substitution']","['diastolic blood pressure', 'blood pressure and hypertension incidence', 'community-wide blood pressure and hypertension incidence', 'risk of developing hypertension', 'sodium levels', 'blood pressure', 'potassium levels']","[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0031238', 'cui_str': 'Peru'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}]","[{'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0428291', 'cui_str': 'Finding of sodium level (finding)'}, {'cui': 'C0428289', 'cui_str': 'Finding of potassium level (finding)'}]",2376.0,0.348205,"The fully adjusted intention-to-treat analysis showed an average reduction of 1.29 mm Hg (95% confidence interval (95% CI) (-2.17, -0.41)) in systolic and 0.76 mm Hg (95% CI (-1.39, -0.13)) in diastolic blood pressure.","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bernabe-Ortiz', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Víctor G', 'Initials': 'VG', 'LastName': 'Sal Y Rosas', 'Affiliation': 'Department of Science, Pontifica Universidad Católica del Perú, Lima, Peru.'}, {'ForeName': 'Vilarmina', 'Initials': 'V', 'LastName': 'Ponce-Lucero', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'María K', 'Initials': 'MK', 'LastName': 'Cárdenas', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Rodrigo M', 'Initials': 'RM', 'LastName': 'Carrillo-Larco', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Diez-Canseco', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'M Amalia', 'Initials': 'MA', 'LastName': 'Pesantes', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Sacksteder', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Gilman', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'J Jaime', 'Initials': 'JJ', 'LastName': 'Miranda', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru. Jaime.Miranda@upch.pe.'}]",Nature medicine,['10.1038/s41591-020-0754-2']
163,32303761,Pregnant Smokers Receiving Opioid Agonist Therapy Have an Elevated Nicotine Metabolite Ratio: A Replication Study.,"INTRODUCTION


Pregnant women exposed chronically to opioids smoked more cigarettes per day (CPD) and had a higher nicotine metabolite ratio (NMR), 3-hydroxycotinine/cotinine, a biomarker of nicotine metabolism and clearance, than those not receiving opioids. We examined CPD and NMR in a group of pregnant smokers, a quarter of whom were receiving opioid agonist therapy (OAT).
AIMS AND METHODS


Pregnant smokers recruited to participate in a placebo-controlled trial of bupropion for smoking cessation provided a blood sample for measurement of NMR.
RESULTS


Half (52.4%) of the 124 women with NMR data were African American. OAT-treated women (n = 34, 27.4%; 27 receiving methadone and 7 buprenorphine) were more likely to be white (79% vs. 30%, p < .001) and to have a lower mean PHQ-9 total score (2.91 [SD = 2.83] vs. 4.83 [SD = 3.82], p = .007). OAT-treated women reported smoking more CPD (9.50 [SD = 5.26] vs. 7.20 [SD = 3.65], p = .005) and had higher NMR (0.78 [SD = 0.36] vs. 0.56 [SD = 0.25], p = .001) than the non-OAT-treated group. In a linear regression analysis adjusting for race, depression severity, and CPD, NMR was greater in the OAT group (p = .025), among whom the daily methadone-equivalent dosage correlated with NMR (Spearman's ρ = 0.49, p = .003).
CONCLUSIONS


Consistent with the findings of Oncken et al. (2019), we found that OAT smokers smoked more and had higher NMR than non-OAT smokers. As higher NMR is associated with a reduced likelihood of smoking cessation, the effects on NMR of both pregnancy and OAT could contribute to a lower smoking cessation rate in pregnant smokers receiving chronic opioid therapy.
IMPLICATIONS


We replicated the finding that the NMR is significantly greater among pregnant smokers receiving OAT than those not receiving this treatment for opioid use disorder. Furthermore, we found that the dosage of the OAT was significantly associated with the NMR level. These findings may contribute to a poorer response to smoking cessation treatment in pregnant women treated with OAT, particularly those receiving high-dose therapy, and raise the question of whether novel approaches are needed to treat smoking in this subgroup of pregnant smokers.",2020,"INTRODUCTION


Pregnant women exposed chronically to opioids smoked more cigarettes/day (CPD) and had a higher nicotine metabolite ratio (NMR: 3-hydroxycotinine (3HC)/cotinine), a biomarker of nicotine metabolism and clearance, than those not receiving opioids (Oncken et al 2019).","['124 women with NMR data were African American', 'pregnant smokers receiving chronic opioid therapy', 'Pregnant Smokers Receiving', 'OAT-treated women [N=34 (27.4', 'pregnant smokers, a quarter of whom were receiving opioid agonist therapy (OAT', 'Pregnant women exposed chronically to opioids smoked more cigarettes/day (CPD) and had a higher', 'Pregnant smokers recruited to participate in a']","['bupropion', 'Opioid Agonist Therapy', 'nicotine metabolite ratio (NMR: 3-hydroxycotinine (3HC)/cotinine', 'buprenorphine', 'placebo', 'CPD and NMR', 'methadone']","['mean PHQ-9 total score', 'depression severity, and CPD, NMR']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C5192328', 'cui_str': '27.4'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0063125', 'cui_str': 'Trans-3-hydroxycotinine'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0055816', 'cui_str': 'citrate phosphate dextrose'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0055816', 'cui_str': 'citrate phosphate dextrose'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",124.0,0.0365849,"INTRODUCTION


Pregnant women exposed chronically to opioids smoked more cigarettes/day (CPD) and had a higher nicotine metabolite ratio (NMR: 3-hydroxycotinine (3HC)/cotinine), a biomarker of nicotine metabolism and clearance, than those not receiving opioids (Oncken et al 2019).","[{'ForeName': 'Henry R', 'Initials': 'HR', 'LastName': 'Kranzler', 'Affiliation': 'Center for Studies of Addiction, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Washio', 'Affiliation': 'Substance Use, Gender and Applied Research, RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Leah R', 'Initials': 'LR', 'LastName': 'Zindel', 'Affiliation': 'Center for Studies of Addiction, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Lynch', 'Affiliation': 'Center for Studies of Addiction, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Hand', 'Affiliation': 'Departments of Obstetrics & Gynecology and Psychiatry & Human Behavior, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Tyndale', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Oncken', 'Affiliation': 'Departments of Medicine and Obstetrics and Gynecology, University of Connecticut School of Medicine, Farmington, CT.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schnoll', 'Affiliation': 'Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa066']
164,32299247,Objective and subjective vasomotor symptom outcomes in the CBT-Meno randomized controlled trial.,"Objective:  Vasomotor symptoms (hot flashes, night sweats) are common during the menopausal transition. Pharmacotherapy is effective but is associated with health risks for some women. There is an increasing demand for non-pharmacological interventions. The CBT-Meno protocol is a psychological intervention targeting a range of common menopausal symptoms. We compared the impact of CBT-Meno vs. waitlist on objective and subjective measures of vasomotor symptoms and on the relationship between vasomotor symptoms and sleep difficulties. Materials:  The participants were 36 perimenopausal or postmenopausal women with co-occurring depressive symptoms who participated in the CBT-Meno trial (clinicaltrials.gov NCT02480192). Subjective measures included the Hot Flash Related Daily Interference Scale, the Greene Climacteric Scale, and the Pittsburgh Sleep Quality Inventory. Objective (physiological) and 'in-the-moment' measures of vasomotor symptoms were assessed with sternal skin conductance. Results:  Greater improvements in vasomotor 'bothersomeness' and 'interference' were observed in the CBT-Meno condition compared to the waitlist condition. No between-group differences were observed in vasomotor frequency (subjectively or objectively recorded) or severity ratings. Sleep disturbance was unrelated to objectively measured vasomotor symptom frequency. Conclusion:  The CBT-Meno trial improved subjective but not objective (physiological) measures of vasomotor symptoms. Self-reported sleep difficulties were unrelated to subjective or objective vasomotor symptoms.",2020,Results:  Greater improvements in vasomotor 'bothersomeness' and 'interference' were observed in the CBT-Meno condition compared to the waitlist condition.,['participants were 36 perimenopausal or postmenopausal women with co-occurring depressive symptoms who participated in the CBT-Meno trial (clinicaltrials.gov NCT02480192'],"['Pharmacotherapy', 'CBT-Meno vs. waitlist']","['vasomotor frequency (subjectively or objectively recorded) or severity ratings', 'Sleep disturbance', 'Objective and subjective vasomotor symptom outcomes', 'Hot Flash Related Daily Interference Scale, the Greene Climacteric Scale, and the Pittsburgh Sleep Quality Inventory', 'sternal skin conductance', 'vasomotor symptoms and sleep difficulties', ""vasomotor 'bothersomeness' and 'interference"", 'Vasomotor symptoms (hot flashes, night sweats']","[{'cui': 'C0910435', 'cui_str': 'AM 36'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008943', 'cui_str': 'Change of Life'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0448823', 'cui_str': 'Sternal skin'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0028081', 'cui_str': 'Night sweats'}]",,0.0745349,Results:  Greater improvements in vasomotor 'bothersomeness' and 'interference' were observed in the CBT-Meno condition compared to the waitlist condition.,"[{'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Green', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Donegan', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'McCabe', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Fedorkow', 'Affiliation': 'Department of Obstetrics and Gynecology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Streiner', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'B N', 'Initials': 'BN', 'LastName': 'Frey', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, ON, Canada.'}]",Climacteric : the journal of the International Menopause Society,['10.1080/13697137.2020.1737929']
165,32301592,The safety and efficacy of zero-fluoroscopy ablation versus conventional ablation in patients with supraventricular tachycardia.,"BACKGROUND


A zero fluoroscopy approach guided by a 3‑dimensional navigation system is an alternative to the traditional conventional fluoroscopy‑navigation approach for ablation of tachycardia.
AIMS


To compare the safety and efficacy of zero fluoroscopy ablation of supraventricular tachycardia (SVT) guided by the CARTO mapping system (CZF) alone, the EnSite zero fluoroscopy mapping system (EZF) alone, or the conventional fluoroscopy (CF) ablation method.
METHODS


From July 2015 to March 2017, patients admitted for SVT ablation were prospectively and consecutively enrolled in the CF, EZF, and CZF groups in a 1:1:1 ratio. The procedures for the CF group were performed using the traditional fluoroscopy method or the 3‑dimensional mapping method. All data were prospectively recorded by independent researchers. Procedure and fluoroscopic time as well as rate of success, recurrence, and complications in the 3 groups were analyzed.
RESULTS


One patient from the CZF group was moved to the CF group due to a severe venous malformation during catheter insertion. A total of 100 patients (100%) in the CF group, 100 patients (100%) in the EZF group (100%), and 99 patients (99%) in the CZF group successfully completed the electrophysiology study. There were no severe complications in any of the groups. The mean (SD) procedure time was 61.8 (36.2), 66.5 (24.2), and 65.4 (27.5) minutes in the CF, EZF, and CZF group, respectively. The median (interquartile range) fluoroscopy time of the CF group was 3.6 (2.1-8.8) minutes.
CONCLUSIONS


The zero fluoroscopy approach guided by the CARTO system is not inferior to the zero fluoroscopy approach guided by the EnSite system or a conventional fluoroscopic approach in terms of the efficiency and safety for ablation of SVT.",2020,A zero--fluoroscopic approach guided by the CARTOTM system is not inferior to a zero--fluoroscopic approach guided by the EnSiteTM system or a conventional fluoroscopic approach in terms of efficiency and safety for SVT ablation.,"['patients with supraventricular tachycardia', 'From July 2015 to March 2017, patients admitted for SVT ablation were consecutively enrolled in the CF, EZF, and CZF groups in a 1:1:1 ratio']","['zero fluoroscopic ablation of supraventricular tachycardia (SVT) guided by the CARTOTM mapping system (CZF) alone, the EnSiteTM zero fluoroscopic mapping system (EZF) alone, or the conventional fluoroscopy (CF) ablation method', 'CZF', 'CF', 'zero-fluoroscopy ablation versus conventional ablation', 'fluoroscopy radiofrequency catheter ablation']","['median/quartile fluoroscopy time', 'severe complications', 'safety and efficacy', 'severe venous malformation', 'mean (SD) procedure time', 'Procedure and fluoroscopic time, and rate of success, recurrence, and complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0162561', 'cui_str': 'Radiofrequency Catheter Ablation'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0265950', 'cui_str': 'Venous malformation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0263017,A zero--fluoroscopic approach guided by the CARTOTM system is not inferior to a zero--fluoroscopic approach guided by the EnSiteTM system or a conventional fluoroscopic approach in terms of efficiency and safety for SVT ablation.,"[{'ForeName': 'Alselmi', 'Initials': 'A', 'LastName': 'Fadhle', 'Affiliation': ''}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}]",Kardiologia polska,['10.33963/KP.15293']
166,32302504,Vitamin B12 Supplementation in Addition to Folic Acid and Iron Improves Hematological and Biochemical Markers in Pregnancy: A Randomized Controlled Trial.,"Vitamin B12 plays an important role in cell division and is of vital importance during pregnancy. Iron and B12 deficiency increase the risk of neonatal morbidity and the outcome of the overall pregnancy. The aim of our study was to analyze whether the use of vitamin B12, with standard supplements of folic acid and iron among nonanemic pregnant women, will result in improvements of hemogram parameters in terms of hematological and biochemical markers. Study participants were 200 healthy pregnant women, randomized into an intervention group and a control group, recruited from gynecological primary care practices in Split, Croatia. In addition to standard supplementation (350 mg/day ferrous iron, 5 mg folic acid), participants in the intervention group were given 5  μ g of vitamin B12 each morning for 100 days. Both biochemical and hematological measurings were conducted in two intervals: 8th-10th week of gestation and then again in the 34th-36th week of gestation. Participants in the control group were given only standard-of-care iron and folic acid supplementation. Significantly lower values of haptoglobin postintervention, compared with baseline, were found only in the intervention group; for erythrocytes, significantly lower values postintervention were found only in the control group. For parameter hematocrit, we found decreased values postintervention, compared with baseline, in both intervention and control group; however, this decrease was within the reference range for the control group, whereas it was above the reference range for the intervention group. The results of this study indicated that intervention with vitamin B12 in pregnancy reduces possibilities of the onset of anemia, but within reference range.",2020,"Significantly lower values of haptoglobin postintervention, compared with baseline, were found only in the intervention group; for erythrocytes, significantly lower values postintervention were found only in the control group.","['nonanemic pregnant women', 'Study participants were 200 healthy pregnant women', 'Pregnancy']","['standard-of-care iron and folic acid supplementation', 'Folic Acid and Iron', 'standard supplementation (350\u2009mg/day ferrous iron, 5\u2009mg folic acid', 'Vitamin B12 Supplementation', 'gynecological primary care practices in Split, Croatia', 'vitamin B12, with standard supplements of folic acid and iron']","['haptoglobin postintervention', 'risk of neonatal morbidity']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplement agent'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C4524262', 'cui_str': 'Vitamin B12 supplementation'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0018595', 'cui_str': 'Haptoglobin'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",200.0,0.119214,"Significantly lower values of haptoglobin postintervention, compared with baseline, were found only in the intervention group; for erythrocytes, significantly lower values postintervention were found only in the control group.","[{'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Zec', 'Affiliation': 'Department of Transfusion Medicine, Split University Hospital, Split, Croatia.'}, {'ForeName': 'Damir', 'Initials': 'D', 'LastName': 'Roje', 'Affiliation': 'Department of Obstetrics and Gynecology, Split University Hospital, Split, Croatia.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Matovinović', 'Affiliation': 'Department of Internal Medicine, University Hospital Centre Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Antičević', 'Affiliation': 'University Department of Health Studies, University of Split, Split, Croatia.'}, {'ForeName': 'Ljubica', 'Initials': 'L', 'LastName': 'Librenjak Škare', 'Affiliation': 'Department of Internal Medicine, Split University Hospital, Split, Croatia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Jerončić', 'Affiliation': 'Research in Biomedicine and Health, University of Split School of Medicine, Split, Croatia.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Puljak', 'Affiliation': 'Center for Evidence-Based Medicine and Health Care, Catholic University of Croatia, Zagreb, Croatia.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Madunić', 'Affiliation': 'Department of Internal Medicine, Split University Hospital, Split, Croatia.'}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Meštrović', 'Affiliation': 'Department of Obstetrics and Gynecology, Split University Hospital, Split, Croatia.'}]",Journal of medicinal food,['10.1089/jmf.2019.0233']
167,32029450,"Patient preferences for symptom-driven or regular preventer treatment in mild to moderate asthma: findings from the PRACTICAL study, a randomised clinical trial.","Symptom-driven low-dose inhaled corticosteroid-formoterol is safe and effective in mild asthma and has been recommended as one of the preferred treatment regimens at steps 1 and 2 in the 2019 update of the Global Initiative for Asthma. However, there are no data on patient preferences for this regimen.A subgroup of participants in the PRACTICAL study (ACTRN12616000377437), a randomised controlled trial comparing symptom-driven budesonide-formoterol with maintenance budesonide plus as-needed terbutaline completed a survey on treatment preferences, satisfaction, beliefs and experience at their final study visit.306 (75%) out of 407 eligible participants completed the survey. Regimen preference was strongly associated with randomised treatment, as were preferences for and beliefs about preventer inhaler use. Combination preventer and reliever as-needed therapy was preferred by 135 (90%, 95% CI 85.2-94.8%) out of 150 who were randomised to as-needed budesonide-formoterol, and by 63 (40%, 95% CI 32.7-48.1%) out of 156 who were randomised to maintenance budesonide. By contrast, twice-daily preventer inhaler with a reliever inhaler as required was preferred by 15 (10%) out of 150 of those randomised to as-needed budesonide-formoterol and 93 (60%) out of 156 of those randomised to maintenance budesonide. Satisfaction with all study inhalers was high. Of patients randomised to as-needed budesonide-formoterol 92% (n=138) were confident using it as a reliever at the end of the study.Although most participants preferred the regimen to which they had been randomised, this association was much stronger for those randomised to budesonide-formoterol as needed, indicating that most patients preferred as-needed corticosteroid-formoterol therapy if they had experienced it.",2020,"Although most participants preferred the regimen to which they had been randomised, this association was much stronger for those randomised to budesonide-formoterol as needed, indicating that most patients preferred as-needed corticosteroid-formoterol therapy if they had experienced it.",['407 eligible participants (75%) completed the survey'],"['maintenance budesonide', 'corticosteroid-formoterol', 'budesonide-formoterol', 'budesonide-formoterol with maintenance budesonide']",[],"[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}]",[],407.0,0.259245,"Although most participants preferred the regimen to which they had been randomised, this association was much stronger for those randomised to budesonide-formoterol as needed, indicating that most patients preferred as-needed corticosteroid-formoterol therapy if they had experienced it.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Baggott', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Helen K', 'Initials': 'HK', 'LastName': 'Reddel', 'Affiliation': 'Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Hardy', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Sparks', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Holliday', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Corin', 'Affiliation': 'Clinical Horizons, Tauranga, New Zealand.'}, {'ForeName': 'Barney', 'Initials': 'B', 'LastName': 'Montgomery', 'Affiliation': 'Optimal Clinical Trials Ltd, Auckland, New Zealand.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Reid', 'Affiliation': 'RMC Research Ltd, Dunedin, New Zealand.'}, {'ForeName': 'Davitt', 'Initials': 'D', 'LastName': 'Sheahan', 'Affiliation': 'Papamoa Pines Medical Centre, Tauranga, New Zealand.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hancox', 'Affiliation': 'Waikato Hospital, Hamilton, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weatherall', 'Affiliation': 'University of Otago Wellington, Wellington, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fingleton', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.02073-2019']
168,32300013,"Asking young children to ""do science"" instead of ""be scientists"" increases science engagement in a randomized field experiment.","Subtle features of common language can imply to young children that scientists are a special and distinct kind of person-a way of thinking that can interfere with the development of children's own engagement with science. We conducted a large field experiment (involving 45 prekindergarten schools, 130 teachers, and over 1,100 children) to test if targeting subtle properties of language can increase science engagement in children's daily lives. Despite strong tendencies to describe scientists as a special kind of person (in a baseline control condition), brief video-based training changed the language that teachers used to introduce science to their students. These changes in language were powerful enough to predict children's science interest and behavior days later. Thus, subtle features of language shape children's beliefs and behaviors as they unfold in real world environments. Harnessing these mechanisms could promote science engagement in early childhood.",2020,"Despite strong tendencies to describe scientists as a special kind of person (in a baseline control condition), brief video-based training changed the language that teachers used to introduce science to their students.","[""children's daily lives"", '45 prekindergarten schools, 130 teachers, and over 1,100 children']",[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]",[],[],1100.0,0.0458692,"Despite strong tendencies to describe scientists as a special kind of person (in a baseline control condition), brief video-based training changed the language that teachers used to introduce science to their students.","[{'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Rhodes', 'Affiliation': 'Department of Psychology, New York University, New York, NY 10003; marjorie.rhodes@nyu.edu.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Cardarelli', 'Affiliation': 'Department of Psychology, New York University, New York, NY 10003.'}, {'ForeName': 'Sarah-Jane', 'Initials': 'SJ', 'LastName': 'Leslie', 'Affiliation': 'Department of Philosophy, Princeton University, Princeton, NJ 08544.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1919646117']
169,30824647,Radiographic Progression According to Baseline C-reactive Protein Levels and Other Risk Factors in Psoriatic Arthritis Treated with Tofacitinib or Adalimumab.,"OBJECTIVE


To evaluate the effect of baseline risk factors on radiographic progression in patients with active psoriatic arthritis (PsA) who had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and were treated with tofacitinib or adalimumab (ADA).
METHODS


Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA. OPAL Broaden was a 12-month, double-blind phase III trial. Patients received tofacitinib 5 mg twice daily (BID; n = 107), tofacitinib 10 mg BID (n = 104), or ADA 40 mg once every 2 weeks (n = 106), all with 1 background csDMARD. Radiographs (baseline and Month 12) were scored using the van der Heijde-modified total Sharp score (mTSS) for PsA. Radiographic nonprogression was defined as an increase from baseline in mTSS ≤ 0.5, ≤ 0, or ≤ 0.66. Changes from baseline in mTSS and nonprogression (≤ 0.5 increase from baseline in mTSS) were analyzed by baseline C-reactive protein (CRP) > 2.87 or ≤ 2.87 mg/l. Baseline predictors of radiographic progression were analyzed.
RESULTS


At Month 12, > 90% of patients receiving tofacitinib or ADA met all radiographic nonprogression criteria. Mean changes from baseline through Month 12 in mTSS, erosion, and joint space narrowing scores were close to 0. Changes in radiographic outcomes were minimal, irrespective of baseline CRP levels > 2.87 or ≤ 2.87 mg/l, with a small numerical difference observed for tofacitinib 5 mg BID. A significant relationship was observed between baseline CRP level and increases from baseline in mTSS > 0.5 at Month 12.
CONCLUSION


Elevated CRP levels at baseline were associated with greater structural progression. Changes in radiographic outcomes were minimal regardless of CRP levels. [Clinical trial registration number (www.ClinicalTrials.gov): NCT01877668].",2019,"A significant relationship was observed between baseline CRP level and increases from baseline in mTSS > 0.5 at Month 12.
",['patients with active psoriatic arthritis (PsA) who had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and were treated with'],"['tofacitinib', 'Tofacitinib or Adalimumab', 'ADA', 'tofacitinib or adalimumab (ADA', 'tofacitinib 10 mg BID']","['Radiographic Progression', 'Elevated CRP levels', 'baseline CRP level', 'radiographic progression', 'radiographic outcomes', 'erosion, and joint space narrowing scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4704009', 'cui_str': 'tofacitinib 10 MG'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}, {'cui': 'C1859695'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",107.0,0.418,"A significant relationship was observed between baseline CRP level and increases from baseline in mTSS > 0.5 at Month 12.
","[{'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': ""From the Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands; Department of Rheumatology, University of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada; Department of Rheumatology, St. Vincent's University Hospital, Dublin, Ireland; Division of Rheumatology, Allergy, and Immunology, University of California, San Diego School of Medicine, La Jolla, San Diego, California, USA; Pfizer Inc., Groton, Connecticut, USA; Pfizer Inc., Montreal, Quebec, Canada. mail@dvanderheijde.nl.""}, {'ForeName': 'Dafna D', 'Initials': 'DD', 'LastName': 'Gladman', 'Affiliation': ""From the Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands; Department of Rheumatology, University of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada; Department of Rheumatology, St. Vincent's University Hospital, Dublin, Ireland; Division of Rheumatology, Allergy, and Immunology, University of California, San Diego School of Medicine, La Jolla, San Diego, California, USA; Pfizer Inc., Groton, Connecticut, USA; Pfizer Inc., Montreal, Quebec, Canada.""}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'FitzGerald', 'Affiliation': ""From the Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands; Department of Rheumatology, University of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada; Department of Rheumatology, St. Vincent's University Hospital, Dublin, Ireland; Division of Rheumatology, Allergy, and Immunology, University of California, San Diego School of Medicine, La Jolla, San Diego, California, USA; Pfizer Inc., Groton, Connecticut, USA; Pfizer Inc., Montreal, Quebec, Canada.""}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': ""From the Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands; Department of Rheumatology, University of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada; Department of Rheumatology, St. Vincent's University Hospital, Dublin, Ireland; Division of Rheumatology, Allergy, and Immunology, University of California, San Diego School of Medicine, La Jolla, San Diego, California, USA; Pfizer Inc., Groton, Connecticut, USA; Pfizer Inc., Montreal, Quebec, Canada.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Graham', 'Affiliation': ""From the Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands; Department of Rheumatology, University of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada; Department of Rheumatology, St. Vincent's University Hospital, Dublin, Ireland; Division of Rheumatology, Allergy, and Immunology, University of California, San Diego School of Medicine, La Jolla, San Diego, California, USA; Pfizer Inc., Groton, Connecticut, USA; Pfizer Inc., Montreal, Quebec, Canada.""}, {'ForeName': 'Cunshan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""From the Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands; Department of Rheumatology, University of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada; Department of Rheumatology, St. Vincent's University Hospital, Dublin, Ireland; Division of Rheumatology, Allergy, and Immunology, University of California, San Diego School of Medicine, La Jolla, San Diego, California, USA; Pfizer Inc., Groton, Connecticut, USA; Pfizer Inc., Montreal, Quebec, Canada.""}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Fallon', 'Affiliation': ""From the Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands; Department of Rheumatology, University of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada; Department of Rheumatology, St. Vincent's University Hospital, Dublin, Ireland; Division of Rheumatology, Allergy, and Immunology, University of California, San Diego School of Medicine, La Jolla, San Diego, California, USA; Pfizer Inc., Groton, Connecticut, USA; Pfizer Inc., Montreal, Quebec, Canada.""}]",The Journal of rheumatology,['10.3899/jrheum.180971']
170,31189338,Randomized controlled trial of supportive care interventions to manage psychological distress and symptoms in Latinas with breast cancer and their informal caregivers.,"Objective:  The purpose of this study was to test two 2-month psychosocial interventions (Telephone Interpersonal Counseling [TIPC] and Supportive Health Education [SHE]) to improve quality of life (QOL) outcomes for Latinas with breast cancer and their informal caregivers.  Methods:  Two hundred and forty-one Latinas with breast cancer and their caregivers were assessed at baseline, immediately after the 2-month intervention, at 4 and 6 months after baseline. QOL outcomes were psychological distress, symptoms and social support.  Results:  Linear mixed effects models showed that for cancer survivors at 2 months, TIPC produced lower adjusted mean depression scores compared to SHE. At 4 months, SHE had reduced total number of symptoms, global symptom distress, and social isolation compared to TIPC. Only total number of symptoms was lower in SHE than in TIPC at 6 months. Among caregivers at 2 months, total number of symptoms, global symptom distress, and anxiety were lower, and self-efficacy for symptom management was higher in SHE compared to TIPC. Caregiver depression was lower in TIPC compared to SHE at 4 months.  Conclusions:  These telephone delivered interventions improved different outcomes. TIPC demonstrated superior benefits for depression management and SHE was more successful in anxiety and cancer-related symptom management.",2020,"At 4 months, SHE had reduced total number of symptoms, global symptom distress, and social isolation compared to TIPC.","['Latinas with breast cancer and their informal caregivers', 'Two hundred and forty-one']","['supportive care interventions', 'TIPC', 'psychosocial interventions (Telephone Interpersonal Counseling [TIPC] and Supportive Health Education [SHE']","['psychological distress, symptoms and social support', 'mean depression scores', 'Caregiver depression', 'total number of symptoms, global symptom distress, and social isolation', 'total number of symptoms', 'total number of symptoms, global symptom distress, and anxiety were lower, and self-efficacy for symptom management', 'quality of life (QOL) outcomes']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0018701'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037438'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0034380'}]",241.0,0.0508074,"At 4 months, SHE had reduced total number of symptoms, global symptom distress, and social isolation compared to TIPC.","[{'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Badger', 'Affiliation': 'College of Nursing, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Segrin', 'Affiliation': 'Department of Communication, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Sikorskii', 'Affiliation': 'Department of Psychiatry, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Pasvogel', 'Affiliation': 'Department of Communication, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Weihs', 'Affiliation': 'Department of Psychiatry, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Lopez', 'Affiliation': 'Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Pavani', 'Initials': 'P', 'LastName': 'Chalasani', 'Affiliation': 'University of Arizona Cancer Center, Tucson, AZ, USA.'}]",Psychology & health,['10.1080/08870446.2019.1626395']
171,32299254,Pain management during diagnostic office hysteroscopy in postmenopausal women: a randomized study.,"Objective:  This study aimed to compare efficacy and safety of lidocaine versus tramadol versus placebo in reducing the pain of diagnostic outpatient hysteroscopy (OH) in postmenopausal women. Materials and methods:  This randomized double-blinded study included 156 menopausal women who received intrauterine lidocaine infusion or oral tramadol (50 mg) or placebo before diagnostic OH (52 women/group). Primary outcome was pain severity during the procedure using a 10-cm visual analog scale. Secondary outcomes were pain scores 10 and 30 min post procedure, satisfaction level, and ease of cervical entry. Results:  Lidocaine had lower pain scores compared to placebo during and 10 min after the procedure ( p  < 0.001). Tramadol had lower pain scores than placebo during the procedure ( p  = 0.04), 10 min after the procedure ( p  = 0.03), and 30 min after the procedure ( p  = 0.04). Both lidocaine and tramadol resulted in an easier procedure than placebo ( p  < 0.001 and  p  = 0.04, respectively). Lidocaine had an easier cervical entry compared to tramadol ( p  = 0.004). Satisfaction scores in the lidocaine and tramadol groups were significantly higher than in the placebo group ( p  < 0.001). Conclusions:  Lidocaine and tramadol were effective in reducing postmenopausal women-reported pain during and after diagnostic OH. However, lidocaine was better than tramadol in facilitating hysteroscope passage through the cervical canal and the reduction in pain levels with lidocaine was clinically relevant. Trial registration number:  NCT03701984.",2020,Lidocaine had lower pain scores compared to placebo during and 10 min after the procedure ( p  < 0.001).,"['before diagnostic OH (52 women/group', '156 menopausal women who received', 'postmenopausal women']","['Lidocaine', 'lidocaine', 'placebo', 'tramadol', 'intrauterine lidocaine infusion or oral tramadol (50\u2009mg) or placebo', 'diagnostic office hysteroscopy', 'Lidocaine and tramadol', 'Tramadol']","['pain levels', 'postmenopausal women-reported pain', 'lower pain scores', 'pain of diagnostic outpatient hysteroscopy (OH', 'Satisfaction scores', 'easier cervical entry', 'pain scores 10 and 30\u2009min post procedure, satisfaction level, and ease of cervical entry', 'efficacy and safety', 'pain severity during the procedure using a 10-cm visual analog scale', 'Pain management']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",156.0,0.686822,Lidocaine had lower pain scores compared to placebo during and 10 min after the procedure ( p  < 0.001).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Samy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nabil', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Abdelhakim', 'Affiliation': 'Department of Histology, Kasr Alainy, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Mahy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Abdel-Latif', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Metwally', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Climacteric : the journal of the International Menopause Society,['10.1080/13697137.2020.1742685']
172,32302757,Improving Family Navigation for Children With Autism: A Comparison of Two Pilot Randomized Controlled Trials.,"OBJECTIVE


Family navigation (FN), a care management strategy, helps families overcome systems and person-level barriers to care. We previously demonstrated FN's feasibility, acceptability, and potential efficacy for increasing access and reducing time to autism-related diagnostic services among low-income, minority children. In this paper, we describe modifications to FN in response to concerns raised in our first pilot randomized controlled trial (RCT), and then assess these modifications in a second pilot RCT.
METHODS


An advisory group recommended modifications to recruitment procedures and study conditions. Forty parent-child dyad participants with autism-related concerns were randomized to receive modified usual care (UC) or modified FN. We compared whether the first and second pilot RCTs differed in: participant enrollment, satisfaction with clinical care, and timely completion of the diagnostic assessment.
RESULTS


Recruitment improved under the modified protocol with significantly fewer potentially eligible families refusing (19.5% vs 4.8%, P < .05) or being excluded from study enrollment (43.6% vs 0%, P < .01). Comparing the first and second pilot RCTs, regardless of study arm, families in the second pilot were more likely to complete diagnostic assessment (UC: hazard ratio [HR] 3.41, 95% confidence intervals [CI 1.20, 9.68]; FN: HR 2.64, 95% CI [1.31, 5.30]) and report greater satisfaction with clinical care. In the second pilot, compared to UC, FN continued increase the likelihood of completing the diagnostic assessment (HR: 2.57; 95% CI [1.22, 5.40]).
CONCLUSIONS


Easy-to-implement system-level enhancements improved study recruitment, satisfaction with care, and completion of a diagnostic assessment. With enhancement, FN continued to confer benefits to families.",2020,"In the second pilot, compared to UC, FN continued increase the likelihood of completing the diagnostic assessment (HR: 2.57; 95% CI [1.22, 5.40]).
","['Children with Autism', '40 parent-child dyad participants with autism-related concerns', 'low-income, minority children']","['modified usual care (UC) or modified FN', 'Family Navigation (FN']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",[],,0.105002,"In the second pilot, compared to UC, FN continued increase the likelihood of completing the diagnostic assessment (HR: 2.57; 95% CI [1.22, 5.40]).
","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Feinberg', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, Boston University School of Medicine (E Feinberg, and S Broder-Fingert), Boston, Mass; Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass. Electronic address: emfeinbe@bu.edu.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Kuhn', 'Affiliation': 'Department of Pediatrics, Boston Medical Center (J Kuhn), Boston, Mass.'}, {'ForeName': 'Jenna Sandler', 'Initials': 'JS', 'LastName': 'Eilenberg', 'Affiliation': 'Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Levinson', 'Affiliation': 'Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Patts', 'Affiliation': 'Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Cabral', 'Affiliation': 'Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass.'}, {'ForeName': 'Sarabeth', 'Initials': 'S', 'LastName': 'Broder-Fingert', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, Boston University School of Medicine (E Feinberg, and S Broder-Fingert), Boston, Mass.'}]",Academic pediatrics,['10.1016/j.acap.2020.04.007']
173,31549577,Stabilization of Early Duchenne Cardiomyopathy With Aldosterone Inhibition: Results of the Multicenter AIDMD Trial.,"Background Duchenne muscular dystrophy incurs nearly universal dilated cardiomyopathy by the third decade of life, preceded by myocardial damage and impaired left ventricular strain by cardiac magnetic resonance. It has been shown that (1) mineralocorticoid receptor antagonist therapy with spironolactone attenuated damage while maintaining function when given early in a mouse model and (2) low-dose eplerenone stabilized left ventricular strain in boys with Duchenne muscular dystrophy and evident myocardial damage but preserved ejection fraction. We hypothesized that moderate-dose spironolactone versus eplerenone would provide similar cardioprotection in this first head-to-head randomized trial of available mineralocorticoid receptor antagonists, the AIDMD (Aldosterone Inhibition in Duchenne Muscular Dystrophy) trial. Methods and Results This was a multicenter, double-blind, randomized, noninferiority trial. Subjects were randomized to eplerenone, 50 mg, or spironolactone, 50 mg, orally once daily for 12 months. The primary outcome was change in left ventricular systolic strain at 12 months. Among 52 enrolled male subjects, aged 14 (interquartile range, 12-18) years, spironolactone was noninferior to eplerenone (∆strain, 0.4 [interquartile range, -0.4 to 0.6] versus 0.2 [interquartile range, -0.2 to 0.7];  P =0.542). Renal and pulmonary function remained stable in both groups, and no subjects experienced serious hyperkalemia. Infrequent adverse events included gynecomastia in one subject in the spironolactone arm and facial rash in one subject in the eplerenone arm. Conclusions In boys with Duchenne muscular dystrophy and preserved left ventricular ejection fraction, spironolactone added to background therapy is noninferior to eplerenone in preserving contractile function. These findings support early mineralocorticoid receptor antagonist therapy as effective and safe in a genetic disease with high cardiomyopathy risk. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02354352.",2019,Infrequent adverse events included gynecomastia in one subject in the spironolactone arm and facial rash in one subject in the eplerenone arm.,"['52 enrolled male subjects, aged 14 (interquartile range, 12-18) years, spironolactone was noninferior to eplerenone (∆strain, 0.4 [interquartile range, -0.4 to 0.6] versus 0.2 [interquartile range, -0.2 to 0.7];  P =0.542']","['Aldosterone Inhibition', 'eplerenone, 50\xa0mg, or spironolactone', 'eplerenone', 'spironolactone', 'mineralocorticoid receptor antagonist therapy']","['Renal and pulmonary function', 'facial rash', 'serious hyperkalemia', 'change in left ventricular systolic strain']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}]","[{'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0239521', 'cui_str': 'Rash on face'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]",52.0,0.363838,Infrequent adverse events included gynecomastia in one subject in the spironolactone arm and facial rash in one subject in the eplerenone arm.,"[{'ForeName': 'Subha V', 'Initials': 'SV', 'LastName': 'Raman', 'Affiliation': 'Ohio State University Wexner Medical Center Columbus OH.'}, {'ForeName': 'Kan N', 'Initials': 'KN', 'LastName': 'Hor', 'Affiliation': ""Nationwide Children's Hospital Columbus OH.""}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Mazur', 'Affiliation': 'The Christ Hospital Heart and Vascular Center Cincinnati OH.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cardona', 'Affiliation': 'Ohio State University Wexner Medical Center Columbus OH.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology and Biostatistics University of Maryland College Park MD.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Halnon', 'Affiliation': 'University of California, Los Angeles Los Angeles CA.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Markham', 'Affiliation': 'Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Soslow', 'Affiliation': 'Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Puchalski', 'Affiliation': 'University of Utah Salt Lake City UT.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Auerbach', 'Affiliation': 'University of Colorado Denver CO.'}, {'ForeName': 'Uyen', 'Initials': 'U', 'LastName': 'Truong', 'Affiliation': 'University of Colorado Denver CO.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Smart', 'Affiliation': 'Ohio State University Wexner Medical Center Columbus OH.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'McCarthy', 'Affiliation': 'Ohio State University Wexner Medical Center Columbus OH.'}, {'ForeName': 'Ibrahim M', 'Initials': 'IM', 'LastName': 'Saeed', 'Affiliation': ""Saint Luke's Mid America Heart Institute Kansas City MO.""}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Statland', 'Affiliation': 'University of Kansas Medical Center Kansas City MO.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Kissel', 'Affiliation': 'Department of Neurology Ohio State University Columbus OH.'}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Cripe', 'Affiliation': ""Nationwide Children's Hospital Columbus OH.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.013501']
174,31825647,Lung Screen Uptake Trial (LSUT): Randomized Controlled Clinical Trial Testing Targeted Invitation Materials.,"Rationale:  Low uptake of low-dose computed tomography (LDCT) lung cancer screening, particularly by current smokers of a low socioeconomic position, compromises effectiveness and equity. Objectives:  To compare the effect of a targeted, low-burden, and stepped invitation strategy versus control on uptake of hospital-based Lung Health Check appointments offering LDCT screening. Methods:  In a two-arm, blinded, between-subjects, randomized controlled trial, 2,012 participants were selected from 16 primary care practices using these criteria:  1 ) aged 60 to 75 years,  2 ) recorded as a current smoker within the last 7 years, and  3 ) no prespecified exclusion criteria contraindicating LDCT screening. Both groups received a stepped sequence of preinvitation, invitation, and reminder letters from their primary care practitioner offering prescheduled appointments. The key manipulation was the accompanying leaflet. The intervention group's leaflet targeted psychological barriers and provided low-burden information, mimicking the concept of the U.K. Ministry of Transport's annual vehicle test (""M.O.T. For Your Lungs""). Measurements and Main Results:  Uptake was 52.6%, with no difference between intervention (52.3%) and control (52.9%) groups in unadjusted (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.82-1.16) or adjusted (OR, 0.98; 95% CI, 0.82-1.17) analyses. Current smokers were less likely to attend (adjusted OR, 0.70; 95% CI, 0.56-0.86) than former smokers. Socioeconomic deprivation was significantly associated with lower uptake for the control group only ( P  < 0.01). Conclusions:  The intervention did not improve uptake. Regardless of trial arm, uptake was considerably higher than previous clinical and real-world studies, particularly given that the samples were predominantly lower socioeconomic position smokers. Strategies common to both groups, including a Lung Health Check approach, could represent a minimum standard.Clinical trial registered with www.clinicaltrials.gov (NCT02558101) and registered prospectively with the International Standard Registered Clinical/Social Study (N21774741).",2020,"Current smokers were less likely to attend (adjusted OR, 0.70; 95% CI, 0.56-0.86) than former smokers.","['Lung Screen Uptake Trial (LSUT', '2,012 participants were selected from 16 primary care practices using these criteria:  1 ) aged 60 to 75 years,  2 ) recorded as a current smoker within the last 7 years, and  3 ']","['low-dose computed tomography (LDCT) lung cancer screening', 'stepped sequence of preinvitation, invitation, and reminder letters from their primary care practitioner offering prescheduled appointments', 'intervention group\'s leaflet targeted psychological barriers and provided low-burden information, mimicking the concept of the U.K. Ministry of Transport\'s annual vehicle test (""M.O.T. For Your Lungs']","['Socioeconomic deprivation', 'uptake']","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}]",2012.0,0.164682,"Current smokers were less likely to attend (adjusted OR, 0.70; 95% CI, 0.56-0.86) than former smokers.","[{'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Quaife', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Ruparel', 'Affiliation': 'Lungs for Living Research Centre, UCL Respiratory, Division of Medicine, University College London, London, United Kingdom.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Dickson', 'Affiliation': 'Lungs for Living Research Centre, UCL Respiratory, Division of Medicine, University College London, London, United Kingdom.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Beeken', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'McEwen', 'Affiliation': 'National Centre for Smoking Cessation and Training, Dorchester, United Kingdom.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Baldwin', 'Affiliation': 'Respiratory Medicine Unit, David Evans Research Centre, Nottingham University Hospitals, Nottingham, United Kingdom.'}, {'ForeName': 'Angshu', 'Initials': 'A', 'LastName': 'Bhowmik', 'Affiliation': 'Department of Thoracic Medicine, Homerton University Hospital, London, United Kingdom.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Navani', 'Affiliation': 'Department of Thoracic Medicine, University College London Hospital, London, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sennett', 'Affiliation': 'Killick Street Health Centre, London, United Kingdom.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Duffy', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom; and.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Wardle', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Waller', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Janes', 'Affiliation': 'Lungs for Living Research Centre, UCL Respiratory, Division of Medicine, University College London, London, United Kingdom.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201905-0946OC']
175,31507001,Recurrent atrial fibrillation/flutter detection after ablation or cardioversion using the AliveCor KardiaMobile device: iHEART results.,"OBJECTIVE


This study evaluated the impact of daily ECG (electrocardiogram) self-recordings on time to documented recurrent atrial fibrillation (AF) or atrial flutter (AFL) and time to treatment of recurrent arrhythmia in patients undergoing catheter radiofrequency ablation (RFA) or direct current cardioversion (DCCV) for AF/AFL.
BACKGROUND


AF recurrence rates after RFA and DCCV are 20% to 45% and 60% to 80%, respectively. Randomized trials comparing mobile ECG devices to standard of care have not been performed in an AF/AFL population after treatment.
METHODS


Of 262 patients consented, 238 were randomized to either standard of care (123) or to receive the iHEART intervention (115). Patients in the intervention group were provided with and trained to use an AliveCor KardiaMobile ECG monitor, and were instructed to take and transmit daily ECG recordings. Data were collected from transmitted ECG recordings and patients' electronic health records.
RESULTS


In a multivariate Cox model, the likelihood of recurrence detection was greater in the intervention group (hazard ratio = 1.56, 95% confidence interval [CI]: 1.06-2.30, P = .024). Hazard ratios did not differ significantly for RFA and DCCV procedures. Recurrence during the first month after ablation strongly predicted later recurrence (hazard ratio = 4.53, 95% CI: 2.05-10.00, P = .0006). Time from detection to treatment was shorter for the control group (hazard ratio = 0.33, 95% CI: 0.57-2.92, P < .0001).
CONCLUSIONS


The use of mobile ECG self-recording devices allows for earlier detection of AF/AFL recurrence and may empower patients to engage in shared health decision-making.",2019,"Time from detection to treatment was shorter for the control group (hazard ratio = 0.33, 95% CI: 0.57-2.92, P < .0001).
","['patients undergoing', 'Of 262 patients consented, 238 were randomized to either standard of care (123) or to receive the']","['mobile ECG devices', 'AliveCor KardiaMobile ECG monitor, and were instructed to take and transmit daily ECG recordings', 'daily ECG (electrocardiogram) self-recordings', 'iHEART intervention', 'catheter radiofrequency ablation (RFA) or direct current cardioversion (DCCV', 'mobile ECG self-recording devices']","['likelihood of recurrence detection', 'Hazard ratios', 'recurrent atrial fibrillation (AF) or atrial flutter (AFL', 'Recurrence', 'later recurrence', 'Recurrent atrial fibrillation/flutter detection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0303719', 'cui_str': 'Americium-238 (substance)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0542380', 'cui_str': 'Direct current cardioversion (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0741282', 'cui_str': 'Recurrent atrial fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Auricular Flutter'}]",238.0,0.117432,"Time from detection to treatment was shorter for the control group (hazard ratio = 0.33, 95% CI: 0.57-2.92, P < .0001).
","[{'ForeName': 'Isaac L', 'Initials': 'IL', 'LastName': 'Goldenthal', 'Affiliation': 'Department of Medicine - Cardiology, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Sciacca', 'Affiliation': 'Columbia University School of Nursing, New York, New York.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Riga', 'Affiliation': 'Department of Medicine - Cardiology, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Bakken', 'Affiliation': 'Columbia University School of Nursing, New York, New York.'}, {'ForeName': 'Maurita', 'Initials': 'M', 'LastName': 'Baumeister', 'Affiliation': 'Department of Medicine - Cardiology, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Angelo B', 'Initials': 'AB', 'LastName': 'Biviano', 'Affiliation': 'Department of Medicine - Cardiology, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Dizon', 'Affiliation': 'Department of Medicine - Cardiology, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine - Cardiology, White Plains Hospital, New York, New York.'}, {'ForeName': 'Ketty C', 'Initials': 'KC', 'LastName': 'Wang', 'Affiliation': 'Columbia University School of Nursing, New York, New York.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Whang', 'Affiliation': 'Department of Medicine - Cardiology, Icahn School of Medicine, New York, New York.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Hickey', 'Affiliation': 'Columbia University School of Nursing, New York, New York.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Garan', 'Affiliation': 'Department of Medicine - Cardiology, Columbia University Irving Medical Center, New York, New York.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14160']
176,31785451,Assessment of fibula flap with flexor hallucis longus's effect on head & neck tumor patients' quality of life and function of donor site.,"OBJECTIVE


Free fibular flaps (FFFs) have been widely used in mandibular reconstruction. It is still unclear whether retaining flexor hallucis longus (FHL) is needed for flaps. This study introduces a comparison in quality of life and donor-site function between those who have and haven't harvested FHL with FFF.
METHODS


Patients with FFFs were single-blind-randomly assigned into the FHL group or nFHL group. Patients were followed up preoperatively and 1, 3 and 6 months postoperatively via subjective evaluations (SF-36/AOFAS) and objective evaluation s(muscle strength and range of motion). Patients' hospitalization and intraoperative information, donor site morbidity were recorded.
RESULTS


Each group had 15 patients. The flap harvesting time in FHL group was shorter significantly than nFHL group (125.9 ± 24.8 min vs 146.7 ± 29.9 min, P = 0.048). There were no significant differences in hospitalization information such as operation time, hospitalization days and cost. Donor site morbidities at 1, 3 and 6 months postoperatively showed no significant differences except for the presence of claw toes (nFHL group > FHL group, 40% vs 0, P = 0.017; 53.3% vs 6.7%, P = 0.014; 60.0% vs 13.3%, P = 0.021). There were no significant differences in SF-36 and AOFAS scores. There were no significant differences in muscle strength and range of motion.
CONCLUSION


Excision of the FHL lowered the flap harvesting time. It did not increase donor site morbidity. The impacts on patients' quality of life and foot function were the same. The surgeons can use the FHL without considering the influence on patients if not retaining the FHL.",2020,"Donor site morbidities at 1, 3 and 6 months postoperatively showed no significant differences except for the presence of claw toes (nFHL group > ","['Patients with FFFs', 'head & neck tumor patients']","['FHL', 'nFHL', 'FHL group or nFHL', ""fibula flap with flexor hallucis longus's"", 'Free fibular flaps (FFFs']","['hospitalization information such as operation time, hospitalization days and cost', 'hospitalization and intraoperative information, donor site morbidity', 'muscle strength and range of motion', 'donor site morbidity', ""patients' quality of life and foot function"", 'Donor site morbidities', 'subjective evaluations (SF-36/AOFAS) and objective evaluation s(muscle strength and range of motion', 'quality of life and donor-site function', 'SF-36 and AOFAS scores', 'quality of life and function of donor site', 'flap harvesting time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0016068', 'cui_str': 'Fibula'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0224473', 'cui_str': 'Flexor hallucis longus muscle structure'}, {'cui': 'C0441022', 'cui_str': 'Fibular flap (substance)'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1444716', 'cui_str': 'Donor site (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}]",,0.0534717,"Donor site morbidities at 1, 3 and 6 months postoperatively showed no significant differences except for the presence of claw toes (nFHL group > ","[{'ForeName': 'Youkang', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}, {'ForeName': 'Xuedi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, School of Stomatology, China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Rehabilitation Medicine, Shengjing Hospital of China Medical University, Shenyang, People's Republic of China. Electronic address: zhangzq@sj-hospital.org.""}, {'ForeName': 'Weidi', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': ""Department of Rehabilitation Medicine, Shengjing Hospital of China Medical University, Shenyang, People's Republic of China. Electronic address: liangwd@sj-hospital.org.""}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Department of Rehabilitation Medicine, Shengjing Hospital of China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Zijia', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Oromaxillofacial-Head and Neck Surgery, School of Stomatology, China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Siqi', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Oromaxillofacial-Head and Neck Surgery, School of Stomatology, China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lu', 'Affiliation': ""Department of Oromaxillofacial-Head and Neck Surgery, School of Stomatology, China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Zhongfei', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ""Department of Oromaxillofacial-Head and Neck Surgery, School of Stomatology, China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Dai', 'Affiliation': ""Department of Oromaxillofacial-Head and Neck Surgery, School of Stomatology, China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Weiyi', 'Initials': 'W', 'LastName': 'Duan', 'Affiliation': ""Department of Oromaxillofacial-Head and Neck Surgery, School of Stomatology, China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Xuexin', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': ""Department of Oromaxillofacial-Head and Neck Surgery, School of Stomatology, China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Changfu', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': ""Department of Oromaxillofacial-Head and Neck Surgery, School of Stomatology, China Medical University, Shenyang, People's Republic of China. Electronic address: changfusun@hotmail.com.""}, {'ForeName': 'Fayu', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Department of Oromaxillofacial-Head and Neck Surgery, School of Stomatology, China Medical University, Shenyang, People's Republic of China. Electronic address: lfyhjk@126.com.""}]",Oral oncology,['10.1016/j.oraloncology.2019.104489']
177,32078168,"The effect of sleep restriction, with or without high-intensity interval exercise, on myofibrillar protein synthesis in healthy young men.","KEY POINTS


Sleep restriction has previously been associated with the loss of muscle mass in both human and animal models. The rate of myofibrillar protein synthesis (MyoPS) is a key variable in regulating skeletal muscle mass and can be increased by performing high-intensity interval exercise (HIIE), although the effect of sleep restriction on MyoPS is unknown. In the present study, we demonstrate that participants undergoing a sleep restriction protocol (five nights, with 4 h in bed each night) had lower rates of skeletal muscle MyoPS; however, rates of MyoPS were maintained at control levels by performing HIIE during this period. Our data suggest that the lower rates of MyoPS in the sleep restriction group may contribute to the detrimental effects of sleep loss on muscle mass and that HIIE may be used as an intervention to counteract these effects.
ABSTRACT


The present study aimed to investigate the effect of sleep restriction, with or without high-intensity interval exercise (HIIE), on the potential mechanisms underpinning previously-reported sleep-loss-induced reductions to muscle mass. Twenty-four healthy, young men underwent a protocol consisting of two nights of controlled baseline sleep and a five-night intervention period. Participants were allocated into one of three parallel groups, matched for age,    V   ̇   O   2     peak        , body mass index and habitual sleep duration; a normal sleep (NS) group [8 h time in bed (TIB) each night], a sleep restriction (SR) group (4 h TIB each night), and a sleep restriction and exercise group (SR+EX, 4 h TIB each night, with three sessions of HIIE). Deuterium oxide was ingested prior to commencing the study and muscle biopsies obtained pre- and post-intervention were used to assess myofibrillar protein synthesis (MyoPS) and molecular markers of protein synthesis and degradation signalling pathways. MyoPS was lower in the SR group [fractional synthetic rate (% day -1  ), mean ± SD, 1.24 ± 0.21] compared to both the NS (1.53 ± 0.09) and SR+EX groups (1.61 ± 0.14) (P < 0.05). However, there were no changes in the purported regulators of protein synthesis (i.e. p-AKT ser473  and p-mTOR ser2448  ) and degradation (i.e. Foxo1/3 mRNA and LC3 protein) in any group. These data suggest that MyoPS is acutely reduced by sleep restriction, although MyoPS can be maintained by performing HIIE. These findings may explain the sleep-loss-induced reductions in muscle mass previously reported and also highlight the potential therapeutic benefit of HIIE to maintain myofibrillar remodelling in this context.",2020,MyoPS was lower in the SR group (FSR %,"['participants undergoing a', 'healthy young men', 'Twenty-four healthy, young men']","['sleep restriction, with or without high-intensity interval exercise (HIIE', 'Deuterium Oxide (D 2  O', 'sleep restriction protocol', 'MyoPS', 'normal sleep group (NS, 8\xa0h time in bed (TIB) each night), a sleep restriction group (SR, 4\xa0h TIB each night), and a sleep restriction and exercise group (SR+EX, 4\xa0h TIB each night, with three sessions of HIIE', 'sleep restriction, with or without high-intensity interval exercise']","['rates of MyoPS', 'rate of myofibrillar protein synthesis (MyoPS', 'MyoPS', 'rates of skeletal muscle MyoPS']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0011745', 'cui_str': 'Heavy Water'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004916', 'cui_str': 'Beds'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}]",24.0,0.0152582,MyoPS was lower in the SR group (FSR %,"[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Saner', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Matthew J-C', 'Initials': 'MJ', 'LastName': 'Lee', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Nathan W', 'Initials': 'NW', 'LastName': 'Pitchford', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Jujiao', 'Initials': 'J', 'LastName': 'Kuang', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Roach', 'Affiliation': 'Appleton Institute for Behavioural Science, Central Queensland University, Adelaide, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Garnham', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Tanner', 'Initials': 'T', 'LastName': 'Stokes', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Canada.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Bishop', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Bartlett', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}]",The Journal of physiology,['10.1113/JP278828']
178,31790913,Establishment and validation of a nomogram for predicting the benefit of concurrent chemotherapy in stage II nasopharyngeal carcinoma: A study based on a phase III randomized clinical trial with 10-year follow-up.,"BACKGROUND AND PURPOSE


Our previous phase III randomized trial demonstrated that the addition of concurrent chemotherapy to radiotherapy (RT) could improve survival in stage II nasopharyngeal carcinoma (NPC). Based on the study, we sought to develop a nomogram for predicting the 5-year and 10-year survival of patients with stage II NPC and estimating the benefit of concurrent chemoradiotherapy (CCRT) for individual patients.
MATERIALS AND METHODS


Data of 199 enrolled patients from the original trial was analyzed to build a nomogram. Overall survival (OS) was the primary endpoint. The discrimination and calibration capacities were evaluated using Harrell Concordance Index (C-index) and calibration curves, respectively. Internal validation of the nomogram was performed by a separate cohort of 306 patients from the same cancer center.
RESULT


In training cohort, patients in CCRT group achieved higher 5-year and 10-year OS compared with patients in RT group. Three independent prognostic factors, which were age, N stage and treatment method from multivariable analysis were extracted to enter the nomogram. T stage was also included due to its importance in clinical decisions. The Harrell C-index of the nomogram in training and validation cohort was 0.748 and 0.653 respectively. The calibration curves showed an acceptable agreement between prediction and observed probability.
CONCLUSION


We developed and validated a nomogram to predict the 5-year and 10-year OS in stage II NPC patients. The nomogram could serve as a pragmatic tool in clinical decisions to estimate the individual risk of stage II patients and identify those who could benefit from chemotherapy.",2020,We developed and validated a nomogram to predict the 5-year and 10-year OS in stage II NPC patients.,"['stage II nasopharyngeal carcinoma', 'stage II NPC patients', 'Data of 199 enrolled patients from the original trial was analyzed to build a nomogram', 'stage II nasopharyngeal carcinoma (NPC', '306 patients from the same cancer center', 'patients with stage II NPC']","['concurrent chemotherapy to radiotherapy (RT', 'concurrent chemoradiotherapy (CCRT', 'concurrent chemotherapy', 'CCRT']","['survival', 'Harrell C-index', '5-year and 10-year survival', 'Overall survival (OS', 'discrimination and calibration capacities', 'higher 5-year and 10-year OS']","[{'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C1450294', 'cui_str': 'Nomograms'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",199.0,0.147309,We developed and validated a nomogram to predict the 5-year and 10-year OS in stage II NPC patients.,"[{'ForeName': 'Xue-Song', 'Initials': 'XS', 'LastName': 'Sun', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: sunxs@sysucc.org.cn.'}, {'ForeName': 'Xiao-Yun', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: lixy1@sysucc.org.cn.'}, {'ForeName': 'Bei-Bei', 'Initials': 'BB', 'LastName': 'Xiao', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: xiaobb@sysucc.org.cn.'}, {'ForeName': 'Sai-Lan', 'Initials': 'SL', 'LastName': 'Liu', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: liusl@sysucc.org.cn.'}, {'ForeName': 'Qiu-Yan', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: chenqy@sysucc.org.cn.'}, {'ForeName': 'Lin-Quan', 'Initials': 'LQ', 'LastName': 'Tang', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: tanglq@sysucc.org.cn.'}, {'ForeName': 'Hai-Qiang', 'Initials': 'HQ', 'LastName': 'Mai', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: maihq@sysucc.org.cn.'}]",Oral oncology,['10.1016/j.oraloncology.2019.104490']
179,27481188,A nonrandomized cohort and a randomized study of local control of large hepatocarcinoma by targeting intratumoral lactic acidosis.,"Background


Previous works suggested that neutralizing intratumoral lactic acidosis combined with glucose deprivation may deliver an effective approach to control tumor. We did a pilot clinical investigation, including a nonrandomized (57 patients with large HCC) and a randomized controlled (20 patients with large HCC) study.
Methods


The patients were treated with transarterial chemoembolization (TACE) with or without bicarbonate local infusion into tumor.
Results


In the nonrandomized controlled study, geometric mean of viable tumor residues (VTR) in TACE with bicarbonate was 6.4-fold lower than that in TACE without bicarbonate (7.1% [95% CI: 4.6%–10.9%] vs 45.6% [28.9%–72.0%]; p<0.0001). This difference was recapitulated by a subsequent randomized controlled study. TACE combined with bicarbonate yielded a 100% objective response rate (ORR), whereas the ORR treated with TACE alone was 44.4% (nonrandomized) and 63.6% (randomized). The survival data suggested that bicarbonate may bring survival benefit.
Conclusions


Bicarbonate markedly enhances the anticancer activity of TACE.
Funding


Funded by National Natural Science Foundation of China.
Clinical trial number


ChiCTR-IOR-14005319.",2016,"TACE combined with bicarbonate yielded a 100% objective response rate (ORR), whereas the ORR treated with TACE alone was 44.4% (nonrandomized) and 63.6% (randomized).",['57 patients with large HCC) and a randomized controlled (20 patients with large HCC) studies'],"['TACE', 'TACE combined with bicarbonate', 'transarterial chemoembolization (TACE) with or without bicarbonate local infusion into tumor', 'bicarbonate', 'Bicarbonate']","['objective response rate (ORR', 'geometric mean of viable tumor residues (VTR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0529196', 'cui_str': 'ADAM-17 Protein'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach (qualifier value)'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443348', 'cui_str': 'Viable (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]",57.0,0.122403,"TACE combined with bicarbonate yielded a 100% objective response rate (ORR), whereas the ORR treated with TACE alone was 44.4% (nonrandomized) and 63.6% (randomized).","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Chao', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Cancer Institute, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Jin', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Guangqiang', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Gong', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, United States.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Cancer Institute, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}]",eLife,['10.7554/eLife.15691']
180,31836949,Ability of Serum IgE Concentration to Predict Exacerbation Risk and Benralizumab Efficacy for Patients with Severe Eosinophilic Asthma.,"INTRODUCTION


For patients with eosinophilic asthma with allergic characteristics, understanding the key drivers of exacerbations is important to identify optimal treatment strategies. Benralizumab is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody that significantly reduces exacerbation frequency for patients with severe, uncontrolled eosinophilic asthma. We evaluated the predictive value of baseline blood eosinophil counts vs. serum immunoglobulin E (IgE) concentrations on exacerbation risk and the association of these variables with benralizumab treatment effect.
METHODS


Analyses were performed with data pooled from the phase III SIROCCO and CALIMA benralizumab trials. Crude annual asthma exacerbation rates (AERs) were determined for placebo as a function of baseline blood eosinophil counts and serum IgE concentrations with prespecified blood eosinophil count categories (< 150, ≥ 150 to < 300, ≥ 300 to < 450, ≥ 450 cells/µL) and IgE concentration quartiles (< 62.0, ≥ 62.0 to < 176.2, ≥ 176.2 to < 453.4, and ≥ 453.4 kU/L). We compared AERs for patients receiving benralizumab 30 mg every 8 weeks (first three doses every 4 weeks) vs. placebo for overlapping baseline blood eosinophil count categories and serum IgE concentration quartiles via a regression approach and by continuously using locally weighted regression smoothing analysis.
RESULTS


Exacerbation risk for patients with severe asthma receiving placebo increased with increasing baseline blood eosinophil counts but not with increasing serum IgE concentrations. Addition of baseline atopy status did not influence the relationship between IgE concentrations and exacerbation risk for patients receiving placebo. Patients with blood eosinophil counts ≥ 300 cells/µL had consistent decreases in exacerbation risk with benralizumab relative to placebo across all serum IgE concentration quartiles.
CONCLUSION


Baseline blood eosinophil counts, but not serum IgE concentrations, are an important predictor of exacerbation risk. Patients with severe eosinophilic asthma treated with benralizumab had consistent reductions in exacerbation risk, regardless of IgE concentrations.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov: SIROCCO, NCT01928771; CALIMA, NCT01914757.",2020,"300 cells/µL had consistent decreases in exacerbation risk with benralizumab relative to placebo across all serum IgE concentration quartiles.
","['Patients with Severe Eosinophilic Asthma', 'Patients with severe eosinophilic asthma treated with', 'patients with severe, uncontrolled eosinophilic asthma', 'patients with severe asthma receiving', 'patients with eosinophilic asthma with allergic characteristics', 'Patients with blood eosinophil counts ≥']","['placebo', 'benralizumab', 'Benralizumab']","['IgE concentration quartiles', 'exacerbation risk, regardless of IgE concentrations', 'IgE concentrations and exacerbation risk', 'exacerbation risk', 'Crude annual asthma exacerbation rates (AERs', 'Baseline blood eosinophil counts', 'baseline blood eosinophil counts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0034068', 'cui_str': 'Pulmonary Eosinophilia'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2982078', 'cui_str': 'benralizumab'}]","[{'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",,0.197062,"300 cells/µL had consistent decreases in exacerbation risk with benralizumab relative to placebo across all serum IgE concentration quartiles.
","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Jackson', 'Affiliation': ""Guy's Severe Asthma Centre, Guy's & St Thomas' NHS Trust, Great Maze Pond, London, UK. David.Jackson@gstt.nhs.uk.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Humbert', 'Affiliation': 'AP-HP, Service de Pneumologie, Hôpital Bicêtre, 78 Rue du Général Leclerc, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Hirsch', 'Affiliation': 'AstraZeneca, One MedImmune Way, Gaithersburg, MD, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Newbold', 'Affiliation': 'AstraZeneca, One MedImmune Way, Gaithersburg, MD, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Garcia Gil', 'Affiliation': 'AstraZeneca, Avgda. Diagonal, Barcelona, Spain.'}]",Advances in therapy,['10.1007/s12325-019-01191-2']
181,32297279,Feasibility and Outcome of a Phase II Study of Intensive Induction Chemotherapy in 91 Elderly Patients with AML Evaluated Using a Simplified Multidimensional Geriatric Assessment.,"INTRODUCTION


We prospectively tested in a phase II study high-dose aracytin and idarubicin plus amifostine as induction regimen in 149 patients with acute myeloid leukaemia (AML) aged ≥ 60 years, evaluated by a simplified multidimensional geriatric assessment (MGA).
METHODS


Ninety-one fully or partially fit patients (61%) were allocated to intensive chemotherapy and 58 (39%) frail patients to best supportive care (BSC). Intensively treated patients, showing early death and complete response (CR) rate respectively of 5.5% and 73.6%, received 61 consolidations, followed by autologous transplant (ASCT), stem cell transplantation (SCT) or gemtuzumab ozogamicin, depending on mobilization outcome and donor availability.
RESULTS


The 8-year overall survival (OS) of these patients was 20.4%, with median duration of 11.4 months significantly superior to the 1.5 months of BSC arm (p < 0.001). Hyperleukocytosis and cytogenetics were predictors of survival with a relative risk of 1.8 in patients with poor karyotype without hyperleukocytosis (p = 0.02) and 3 in those with hyperleukocytosis (≥ 50,000/μl) (p = 0.002).
CONCLUSION


MGA allowed tailored post-consolidation in 53.8% of patients after high-dose aracytin induction, with long-term survival doubling that reported in the literature after standard-dose cytarabine regimens.
TRIAL REGISTRATION


The study was registered with the Umin Clinical Trial Registry (www.umin.ac.jp/ctr), number R000014052.",2020,"The 8-year overall survival (OS) of these patients was 20.4%, with median duration of 11.4 months significantly superior to the 1.5 months of BSC arm (p < 0.001).","['149 patients with acute myeloid leukaemia (AML) aged ≥', '91 Elderly Patients with AML Evaluated Using a Simplified Multidimensional Geriatric Assessment', 'Ninety-one fully or partially fit patients (61', 'and 58 (39%) frail patients to best supportive care (BSC']","['Intensive Induction Chemotherapy', 'MGA', 'intensive chemotherapy', 'aracytin and idarubicin plus amifostine']","['8-year overall survival (OS', 'early death and complete response (CR) rate']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015020', 'cui_str': 'Amifostine'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",149.0,0.066301,"The 8-year overall survival (OS) of these patients was 20.4%, with median duration of 11.4 months significantly superior to the 1.5 months of BSC arm (p < 0.001).","[{'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Capelli', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy. debora.capelli@ospedaliriuniti.marche.it.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Saraceni', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Fiorentini', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Chiarucci', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Menotti', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Poloni', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Discepoli', 'Affiliation': 'Cytogenetic Laboratory, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ospedale Salesi, via F. Corridoni, 11, 60100, Ancona, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Leoni', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Attilio', 'Initials': 'A', 'LastName': 'Olivieri', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}]",Advances in therapy,['10.1007/s12325-020-01310-4']
182,32297095,Using Complier Average Causal Effect Estimation to Examine Student Outcomes of the PAX Good Behavior Game When Integrated with the PATHS Curriculum.,"A growing body of research has documented a link between variation in implementation dosage and outcomes associated with preventive interventions. Complier Average Causal Effect (CACE; Jo in J Educ Behav Stat 27:385-409, 2002) analysis allows for estimating program impacts in light of variation in implementation. This study reports intent-to-treat (ITT) and CACE findings from a randomized controlled trial (RCT) testing the impacts of the universal PAX Good Behavior Game (PAX GBG) integrated with Promoting Alternative Thinking Strategies (i.e., PATHS to PAX) and PAX GBG only compared to a control. This study used ratings by 318 K-5 teachers of 1526 at-risk children who, at baseline, were rated as displaying the top 33rd percentile of aggressive-disruptive behavior. Leveraging a prior study on these data (Berg et al. in Admin Policy Ment Health Ment Health Serv Res 44:558-571, https://doi.org/10.1007/s10488-016-0738-1 , 2017), CACE was defined as the effect of intervention assignment for compliers, using two compliance cut points (50th and 75th percentile), on posttest ratings of student academic engagement, social competence, peer relations, emotion regulation, hyperactivity, and aggressive-disruptive behavior. The ITT analyses indicated improvements for students in the integrated condition on ratings of social competence compared to the control condition. The CACE analyses also indicated significant effects of the integrated intervention on social competence, as well as academic engagement and emotion regulation for students in high compliance classrooms. These findings illustrate the importance of considering variation in implementation within the context of RCTs.",2020,"The CACE analyses also indicated significant effects of the integrated intervention on social competence, as well as academic engagement and emotion regulation for students in high compliance classrooms.","['318\xa0K-5 teachers of 1526 at-risk children who, at baseline, were rated as displaying the top 33rd percentile of aggressive-disruptive behavior']","['PAX Good Behavior Game', 'universal PAX Good Behavior Game (PAX GBG']","['ratings of social competence', 'academic engagement and emotion regulation', 'social competence', 'posttest ratings of student academic engagement, social competence, peer relations, emotion regulation, hyperactivity, and aggressive-disruptive behavior']","[{'cui': 'C0108311', 'cui_str': 'capsular polysaccharide K5'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175671', 'cui_str': 'Universal'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}]",,0.0153983,"The CACE analyses also indicated significant effects of the integrated intervention on social competence, as well as academic engagement and emotion regulation for students in high compliance classrooms.","[{'ForeName': 'Catherine P', 'Initials': 'CP', 'LastName': 'Bradshaw', 'Affiliation': 'Curry School of Education and Human Development, University of Virginia, Charlottesville, VA, USA. cpb8g@virginia.edu.'}, {'ForeName': 'Kathan D', 'Initials': 'KD', 'LastName': 'Shukla', 'Affiliation': 'Indian Institute of Management, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Elise T', 'Initials': 'ET', 'LastName': 'Pas', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Juliette K', 'Initials': 'JK', 'LastName': 'Berg', 'Affiliation': 'American Institutes for Research, Washington, DC, USA.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Ialongo', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}]",Administration and policy in mental health,['10.1007/s10488-020-01034-1']
183,32297283,OPADIA Study: Is a Patient Questionnaire Useful for Enhancing Physician-Patient Shared Decision Making on Physical Activity Micro-objectives in Diabetes?,"INTRODUCTION


Regular physical activity (PA) is recommended by all type 2 diabetes mellitus (T2DM) management guidelines. The OPADIA study aimed to determine whether using a specific patient questionnaire (Optima-PA©) could help T2DM patients increase their PA by leading to better physician-patient communication and improved levels of shared decision making concerning Specific, Measurable, Acceptable, Realistic, Timely (SMART)-PA micro-objectives.
METHODS


Physicians participating in this multicentre, prospective, randomised, real-life study were allocated to a standard group (T2DM patients managed according to usual clinical practice, n = 24) or the OPTIMA-PA group (additional use of the questionnaire, n = 30). The main outcome was the percentage of inclusion visits ending with the setting up of at least one SMART-PA micro-objective. Other outcomes were the impact of the OPTIMA-PA questionnaire on patient perceptions of shared decision making (ENTRED questionnaire) and the impact of the OPTIMA-PA questionnaire and establishing SMART-PA micro-objectives as well as patient-perceived physician empathy (ENTRED questionnaire) and GP aptitude for patient-centredness (SEPCQ scores) on patient PA levels over a 3-month period (IPAQ-SF scores).
RESULTS


One hundred twenty-two patients were included in the standard group and 134 in the OPTIMA-PA group. Unexpectedly, more inclusion visits ended with SMART-PA micro-objectives being set up in the standard group (p < 0.001): 81.1% (n = 99/122) versus 59.7% (n = 80/134). However, fewer patients in the OPTIMA-PA group felt that GPs made decisions alone (32% versus 60%; p < 0.0001). Positive correlations were also observed between GP patient-centredness and patient-perceived GP empathy or increased patient PA over the study period.
CONCLUSION


Although the OPTIMA-PA questionnaire did not directly promote setting up of SMART-PA micro-objectives in T2DM patients, the OPADIA study demonstrated that this tool was effective at improving patient-physician relationships by increasing patient involvement in therapeutic decision making. Our study also highlighted the importance of GP aptitude for patient-centredness for improving PA in T2DM patients.",2020,"Positive correlations were also observed between GP patient-centredness and patient-perceived GP empathy or increased patient PA over the study period.
","['Physicians participating in this multicentre', 'T2DM patients', 'One hundred twenty-two patients were included in the standard group and 134 in the OPTIMA-PA group']","['standard group (T2DM patients managed according to usual clinical practice, n\u2009=\u200924) or the OPTIMA-PA', 'Regular physical activity (PA']","['percentage of inclusion visits ending with the setting up of at least one SMART-PA micro-objective', 'patient perceptions of shared decision making (ENTRED questionnaire) and the impact of the OPTIMA-PA questionnaire and establishing SMART-PA micro-objectives as well as patient-perceived physician empathy (ENTRED questionnaire) and GP aptitude for patient-centredness (SEPCQ scores) on patient PA levels']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0003646', 'cui_str': 'Aptitude'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",122.0,0.0234986,"Positive correlations were also observed between GP patient-centredness and patient-perceived GP empathy or increased patient PA over the study period.
","[{'ForeName': 'Silla M', 'Initials': 'SM', 'LastName': 'Consoli', 'Affiliation': 'Paris Descartes University of Medicine, Sorbonne Paris Cité University, Paris, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Department of Sport Medicine and Functional Explorations, University-Hospital (CHU), G. Montpied Hospital, INRA, UMR 1019, UNH, CRNH Auvergne, Clermont University, University of Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Grimaldi', 'Affiliation': 'Service de diabétologie, Institut E3M, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Penfornis', 'Affiliation': ""Service d'endocrinologie, diabétologie et maladies métaboliques, Centre Hospitalier Sud-Francilien de Corbeil-Essonnes, Université Paris-Saclay, Orsay, France.""}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Bineau', 'Affiliation': 'MSD France, Immeuble Carré Michelet, 10/12 Cours Michelet, 92800, Puteaux, France.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Sabin', 'Affiliation': 'Kappa Santé, 4 rue de Cléry, 75002, Paris, France.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Pouriel', 'Affiliation': 'Kappa Santé, 4 rue de Cléry, 75002, Paris, France.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Freund', 'Affiliation': 'Clintec International SARL, Tour D2, 17 bis place des Reflets, 92099, La Défense, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Dejager', 'Affiliation': 'MSD France, Immeuble Carré Michelet, 10/12 Cours Michelet, 92800, Puteaux, France. sylvie.dejager@msd.com.'}]",Advances in therapy,['10.1007/s12325-020-01336-8']
184,32187462,Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol.,"BACKGROUND


Inclisiran inhibits hepatic synthesis of proprotein convertase subtilisin-kexin type 9. Previous studies suggest that inclisiran might provide sustained reductions in low-density lipoprotein (LDL) cholesterol levels with infrequent dosing.
METHODS


We enrolled patients with atherosclerotic cardiovascular disease (ORION-10 trial) and patients with atherosclerotic cardiovascular disease or an atherosclerotic cardiovascular disease risk equivalent (ORION-11 trial) who had elevated LDL cholesterol levels despite receiving statin therapy at the maximum tolerated dose. Patients were randomly assigned in a 1:1 ratio to receive either inclisiran (284 mg) or placebo, administered by subcutaneous injection on day 1, day 90, and every 6 months thereafter over a period of 540 days. The coprimary end points in each trial were the placebo-corrected percentage change in LDL cholesterol level from baseline to day 510 and the time-adjusted percentage change in LDL cholesterol level from baseline after day 90 and up to day 540.
RESULTS


A total of 1561 and 1617 patients underwent randomization in the ORION-10 and ORION-11 trials, respectively. Mean (±SD) LDL cholesterol levels at baseline were 104.7±38.3 mg per deciliter (2.71±0.99 mmol per liter) and 105.5±39.1 mg per deciliter (2.73±1.01 mmol per liter), respectively. At day 510, inclisiran reduced LDL cholesterol levels by 52.3% (95% confidence interval [CI], 48.8 to 55.7) in the ORION-10 trial and by 49.9% (95% CI, 46.6 to 53.1) in the ORION-11 trial, with corresponding time-adjusted reductions of 53.8% (95% CI, 51.3 to 56.2) and 49.2% (95% CI, 46.8 to 51.6) (P<0.001 for all comparisons vs. placebo). Adverse events were generally similar in the inclisiran and placebo groups in each trial, although injection-site adverse events were more frequent with inclisiran than with placebo (2.6% vs. 0.9% in the ORION-10 trial and 4.7% vs. 0.5% in the ORION-11 trial); such reactions were generally mild, and none were severe or persistent.
CONCLUSIONS


Reductions in LDL cholesterol levels of approximately 50% were obtained with inclisiran, administered subcutaneously every 6 months. More injection-site adverse events occurred with inclisiran than with placebo. (Funded by the Medicines Company; ORION-10 and ORION-11 ClinicalTrials.gov numbers, NCT03399370 and NCT03400800.).",2020,"At day 510, inclisiran reduced LDL cholesterol levels by 52.3% (95% confidence interval [CI], 48.8 to 55.7) in the ORION-10 trial and by 49.9% (95% CI, 46.6 to 53.1) in the ORION-11 trial, with corresponding time-adjusted reductions of 53.8% (95% CI, 51.3 to 56.2) and 49.2% (95% CI, 46.8 to 51.6) (P<0.001 for all comparisons vs. placebo).","['Patients with Elevated LDL Cholesterol', 'enrolled patients with atherosclerotic cardiovascular disease (ORION-10 trial) and patients with atherosclerotic cardiovascular disease or an atherosclerotic cardiovascular disease risk equivalent (ORION-11 trial) who had elevated LDL cholesterol levels despite receiving statin therapy at the maximum tolerated dose', 'A total of 1561 and 1617 patients underwent randomization in the ORION-10 and ORION-11 trials, respectively']","['inclisiran', 'placebo']","['low-density lipoprotein (LDL) cholesterol levels', 'Adverse events', 'injection-site adverse events', 'LDL cholesterol levels', 'LDL cholesterol level', 'Mean (±SD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C4307388', 'cui_str': 'inclisiran'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.622195,"At day 510, inclisiran reduced LDL cholesterol levels by 52.3% (95% confidence interval [CI], 48.8 to 55.7) in the ORION-10 trial and by 49.9% (95% CI, 46.6 to 53.1) in the ORION-11 trial, with corresponding time-adjusted reductions of 53.8% (95% CI, 51.3 to 56.2) and 49.2% (95% CI, 46.8 to 51.6) (P<0.001 for all comparisons vs. placebo).","[{'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Wright', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kallend', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Koenig', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Raal', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'Jenna A', 'Initials': 'JA', 'LastName': 'Bisch', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Richardson', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jaros', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'Peter L J', 'Initials': 'PLJ', 'LastName': 'Wijngaard', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'John J P', 'Initials': 'JJP', 'LastName': 'Kastelein', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1912387']
185,32245060,Shifting the Care of Type 2 Diabetes Mellitus from Hospital to Primary Health Care Institutions through an Educational Intervention for Health Care Professionals: An Example from Rural China.,"This study assessed the impact of an educational intervention on the knowledge, attitudes, and practice regarding Type 2 Diabetes Mellitus (T2DM) of Primary Health Care (PHC) professionals, as well as on the types of T2DM care services which they were able to provide. The intervention was carried out in collaboration with county hospitals. The study was conducted from 2015 to 2016 among 241 health care professionals in 18 township health centers and 55 village clinics in three counties in Jiangsu Province, randomly divided into an intervention group and a control group. Participants in the intervention group received professional skills training sessions and team communication and were involved in regular meetings. The control group followed the routine work plan. At one-year follow up, the diabetes knowledge score, practice score, and attitudes score were significantly higher in the intervention group than in the control group. A significantly higher proportion of health care professionals in the intervention group was able to provide services compared with the control group, for all types of services, except T2DM emergency treatment. The intervention among health care professionals in PHC had a positive impact on their professional diabetes skills, knowledge, attitudes, practices, and types of services they were able to provide, at one-year follow-up.",2020,"A significantly higher proportion of health care professionals in the intervention group was able to provide services compared with the control group, for all types of services, except T2DM emergency treatment.","['Type 2 Diabetes Mellitus from Hospital to Primary Health Care Institutions through an Educational Intervention for Health Care Professionals', '2015 to 2016 among 241 health care professionals in 18 township health centers and 55 village clinics in three counties in Jiangsu Province']","['educational intervention', 'professional skills training sessions and team communication and were involved in regular meetings']","['professional diabetes skills, knowledge, attitudes, practices, and types of services', 'diabetes knowledge score, practice score, and attitudes score']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0157337,"A significantly higher proportion of health care professionals in the intervention group was able to provide services compared with the control group, for all types of services, except T2DM emergency treatment.","[{'ForeName': 'Shaofan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Health Outcomes and Economic Evaluation Research Group, Department of Learning, Informatics, Management and Ethics, Stockholm Centre for Healthcare Ethics, Karolinska Institutet, SE-17177 Stockholm, Sweden.'}, {'ForeName': 'Dongfu', 'Initials': 'D', 'LastName': 'Qian', 'Affiliation': 'School of Health Policy and Management, Nanjing Medical University, No. 101 Longmian Avenue, Nanjing 211166, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Burström', 'Affiliation': 'Equity and Health Policy Research Group, Department of Global Public Health, Karolinska Institutet, SE-17177 Stockholm, Sweden.'}]",International journal of environmental research and public health,['10.3390/ijerph17062076']
186,32245274,"The Effects of Comprehensive Sexual and Reproductive Health/Family Planning Intervention Based on Knowledge, Attitudes, and Practices Among the Domestic Migrant Population of Reproductive Age in China: A Randomized Community Study.","Background : Domestic migrant populations are highly mobilized at a sexually active age, and often fail to meet their needs for contraception. Moreover, they assume sexual and reproductive health (SRH) risks and utilize fewer family planning services.  Method : A quasi-experimental trial (community intervention) was adopted. Two-stage stratified cluster sampling was applied to recruit participants in Beijing and Chongqing. A comprehensive SRH/family planning intervention was implemented from August 4 2014 to August 3 2015. Propensity score matching (PSM) and multivariate probit models were adopted. Results: In total, 2100 and 2024 eligible participants were involved, and 815 and 629 pairs were matched by PSM in Beijing and Chongqing, respectively. The knowledge and attitudes of the participants regarding SRH and contraception were significantly improved through the comprehensive intervention. Reversible contraceptive methods were the most prevalent; couples largely decided to utilize condoms and family planning services.  Conclusions : The comprehensive intervention had positive effects on knowledge, attitudes, and practices (KAP) for SRH/family planning among the domestic migrant population. The results acquired can be extrapolated to some extent, and the pattern of this intervention is well geared toward other similar settings in China.",2020,"The comprehensive intervention had positive effects on knowledge, attitudes, and practices (KAP) for SRH/family planning among the domestic migrant population.","['Domestic Migrant Population of Reproductive Age in China', 'In total, 2100 and 2024 eligible participants were involved, and 815 and 629 pairs were matched by PSM in Beijing and Chongqing, respectively']","[' ', 'Comprehensive Sexual and Reproductive Health/Family Planning Intervention']","['knowledge, attitudes, and practices (KAP']","[{'cui': 'C0003063', 'cui_str': 'Domestic Animals'}, {'cui': 'C0026093', 'cui_str': 'Migrant'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1310550', 'cui_str': 'Pteroylpoly-gamma-glutamate carboxypeptidase'}, {'cui': 'C4042832', 'cui_str': 'Peking'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",2100.0,0.033137,"The comprehensive intervention had positive effects on knowledge, attitudes, and practices (KAP) for SRH/family planning among the domestic migrant population.","[{'ForeName': 'Shuang-Fei', 'Initials': 'SF', 'LastName': 'Xu', 'Affiliation': 'School of Public Health, Fudan University, Shanghai 200035, China.'}, {'ForeName': 'Jun-Qing', 'Initials': 'JQ', 'LastName': 'Wu', 'Affiliation': 'NHC Key Lab. of Reproduction Regulation (Shanghai Institute of Planned Parenthood Research), Fudan University, Shanghai 200035, China.'}, {'ForeName': 'Chuan-Ning', 'Initials': 'CN', 'LastName': 'Yu', 'Affiliation': 'Department of Chronic Disease, Longhua District Center for Chronic Disease Control/Mental Health, Shenzhen 510080, China.'}, {'ForeName': 'Yu-Yan', 'Initials': 'YY', 'LastName': 'Li', 'Affiliation': 'NHC Key Lab. of Reproduction Regulation (Shanghai Institute of Planned Parenthood Research), Fudan University, Shanghai 200035, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': 'NHC Key Lab. of Reproduction Regulation (Shanghai Institute of Planned Parenthood Research), Fudan University, Shanghai 200035, China.'}, {'ForeName': 'Yi-Ran', 'Initials': 'YR', 'LastName': 'Li', 'Affiliation': 'NHC Key Lab. of Reproduction Regulation (Shanghai Institute of Planned Parenthood Research), Fudan University, Shanghai 200035, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'NHC Key Lab. of Reproduction Regulation (Shanghai Institute of Planned Parenthood Research), Fudan University, Shanghai 200035, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17062093']
187,31253849,Effects of a coping-oriented supportive programme for people with spinal cord injury during inpatient rehabilitation: a quasi-experimental study.,"STUDY DESIGN


Parallel-group, quasi-experimental study.
OBJECTIVES


To evaluate the effectiveness of a coping-oriented supportive programme (COSP) for people with spinal cord injury (SCI) over a 12-week follow-up.
SETTING


SCI wards in two rehabilitation hospitals of Shaanxi, China.
METHODS


Ninety-nine participants (mean age = 41, 88% males and 74% paraplegia) joined the COSP intervention (n = 50) or attention control (n = 49) group. The COSP intervention was focussed on the facilitation of coping skills and consisted of 8 weekly sessions, whereas the attentional control group was provided with 8 weekly didactic education sessions. Effects of the COSP intervention were determined by primary outcomes (coping and self-efficacy) and secondary outcomes (depression, anxiety, social support, life satisfaction and pain). Data were collected at pre- and post-intervention, as well as 4- and 12-week follow-up.
RESULTS


Intention to treat analysis indicated statistically significant effects (with moderate to large effect sizes, all P-values < 0.01) on participants' maladaptive coping, adaptive coping, self-efficacy, depression, anxiety, satisfaction of social support and life satisfaction immediately post-COSP. Statistically significant effects were found for maladaptive coping, self-efficacy, anxiety, depression, satisfaction of social support and life satisfaction at 4-week follow-up. Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up.
CONCLUSION


The COSP intervention resulted in medium-term psychosocial benefits for people with SCI and has potential for integration into routine inpatient rehabilitation practice.",2020,"Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up.
","['people with spinal cord injury during inpatient rehabilitation', 'SCI wards in two rehabilitation hospitals of Shaanxi, China', 'people with spinal cord injury (SCI', 'Ninety-nine participants (mean age\u2009=\u200941, 88% males and 74% paraplegia) joined the', 'n\u2009=\u200950) or attention control (n\u2009=\u200949) group']","['coping-oriented supportive programme', 'coping-oriented supportive programme (COSP', 'COSP intervention']","['Maladaptive coping, anxiety, satisfaction of social support and life satisfaction', ""participants' maladaptive coping, adaptive coping, self-efficacy, depression, anxiety, satisfaction of social support and life satisfaction"", 'maladaptive coping, self-efficacy, anxiety, depression, satisfaction of social support and life satisfaction', 'primary outcomes (coping and self-efficacy) and secondary outcomes (depression, anxiety, social support, life satisfaction and pain']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037438'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",99.0,0.0323196,"Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""The Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK. yan.li@kcl.ac.uk.""}, {'ForeName': 'Wai Tong', 'Initials': 'WT', 'LastName': 'Chien', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bressington', 'Affiliation': 'The School of Nursing, Faculty of Health and Social Science, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}]",Spinal cord,['10.1038/s41393-019-0320-2']
188,30992480,Clinical efficacy of Professional Continuous Glucose Monitoring in improving glycemic control among children with Type 1 Diabetes Mellitus: An Open-label Randomized Control Trial.,"Frequent self-monitoring of blood glucose (SMBG) is the only accurate method available for insulin dose titration in patients with T1DM. Professional continuous glucose monitoring (p-CGM) is blinded recording of glucose trends over 5-7 days and helps physicians to guide insulin titration to patient. This study was planned to assess efficacy of insulin dose adjustments, based on p-CGM plus SMBG in improving glycemic control compared to SMBG alone. We did an open-label, parallel design, randomized control trial among children (2-10 years) having T1DM for at least 6 months. Subjects in the intervention group were placed on p-CGM (iPRO 2™ Professional CGM, Medtronic, USA) for 3-5 days along with regular SMBG. Data from p-CGM was analyzed by physician and used to guide insulin titration along with SMBG over following 3 months. Control group had only SMBG records for titrating insulin doses. Primary outcome was change in HbA1c 3 months after intervention. A total of 68 eligible children were randomized, 34 each to either arms. Thirty children in intervention group and 33 in control group completed the study and were analyzed. It was found that there was more decreased unit change in HbA1c, percentage of low sugar records and total insulin requirement per day, after 3 months follow-up, in intervention group. However, difference was not significant except for total insulin Units/kg/day (p = 0.014). In sub-group analysis of children with baseline HbA1c >7.5%, there was a significant mean fall of HbA1c by 1.27% (p = 0.045). There were no major adverse events associated with p-CGM. We conclude that addition of p-CGM along with SMBG may help in adjusting insulin dose more effectively especially in children with higher baseline HbA1c.",2019,"However, difference was not significant except for total insulin Units/kg/day (p = 0.014).","['children (2-10 years) having T1DM for at least 6 months', 'children with higher baseline HbA1c', 'children with Type 1 Diabetes Mellitus', '68 eligible children', 'patients with T1DM']","['Professional Continuous Glucose Monitoring', 'Professional continuous glucose monitoring (p-CGM']","['glycemic control', 'unit change in HbA1c, percentage of low sugar records and total insulin requirement']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",68.0,0.0615662,"However, difference was not significant except for total insulin Units/kg/day (p = 0.014).","[{'ForeName': 'K V', 'Initials': 'KV', 'LastName': 'Raviteja', 'Affiliation': 'Pediatric Endocrinology and Diabetes Division, Department of Pediatrics, Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Pediatric Endocrinology and Diabetes Division, Department of Pediatrics, Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh, India. drrakesh.pgi@gmail.com.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'Dayal', 'Affiliation': 'Pediatric Endocrinology and Diabetes Division, Department of Pediatrics, Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh, India.'}, {'ForeName': 'Naresh', 'Initials': 'N', 'LastName': 'Sachdeva', 'Affiliation': 'Department of Endocrinology, Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh, India.'}]",Scientific reports,['10.1038/s41598-019-42555-6']
189,29259802,The effect of the GLP-1 analogue Exenatide on functional connectivity within an NTS-based network in women with and without obesity.,"Objective


The differential effect of GLP-1 agonist Exenatide on functional connectivity of the nucleus tractus solitaries (NTS), a key region associated with homeostasis, and on appetite-related behaviours was investigated in women with normal weight compared with women with obesity.
Methods


Following an 8-h fast, 19 female subjects (11 lean, 8 obese) participated in a 2-d double blind crossover study. Subjects underwent functional magnetic resonance imaging at fast and 30-min post subcutaneous injection of 5 μg of Exenatide or placebo. Functional connectivity was examined with the NTS. Drug-induced functional connectivity changes within and between groups and correlations with appetite measures were examined in a region of interest approach focusing on the thalamus and hypothalamus.
Results


Women with obesity reported less hunger after drug injection. Exenatide administration increased functional connectivity of the left NTS with the left thalamus and hypothalamus in the obese group only and increased the correlation between NTS functional connectivity and hunger scores in all subjects, but more so in the obese.
Conclusions


Obesity can impact the effects of Exenatide on brain connectivity, specifically in the NTS and is linked to changes in appetite control. This has implications for the use of GLP-1 analogues in therapeutic interventions.",2017,"Exenatide administration increased functional connectivity of the left NTS with the left thalamus and hypothalamus in the obese group only and increased the correlation between NTS functional connectivity and hunger scores in all subjects, but more so in the obese.
","['Women with obesity reported less hunger after drug injection', 'women with and without obesity', '19 female subjects (11 lean, 8 obese', 'women with normal weight compared with women with obesity']","['Exenatide', 'GLP-1 analogue Exenatide', 'functional magnetic resonance imaging at fast and 30-min post subcutaneous injection of 5\xa0μg of Exenatide or placebo', 'GLP-1 agonist Exenatide']","['Functional connectivity', 'functional connectivity', 'NTS functional connectivity and hunger scores']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",19.0,0.103905,"Exenatide administration increased functional connectivity of the left NTS with the left thalamus and hypothalamus in the obese group only and increased the correlation between NTS functional connectivity and hunger scores in all subjects, but more so in the obese.
","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Coveleskie', 'Affiliation': 'G Oppenheimer Center for Neurobiology of Stress and Resilience, Ingestive Behavior & Obesity Program UCLA Los Angeles CA USA.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Kilpatrick', 'Affiliation': 'G Oppenheimer Center for Neurobiology of Stress and Resilience, Ingestive Behavior & Obesity Program UCLA Los Angeles CA USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'G Oppenheimer Center for Neurobiology of Stress and Resilience, Ingestive Behavior & Obesity Program UCLA Los Angeles CA USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stains', 'Affiliation': 'G Oppenheimer Center for Neurobiology of Stress and Resilience, Ingestive Behavior & Obesity Program UCLA Los Angeles CA USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Connolly', 'Affiliation': 'David Geffen School of Medicine University of California Los Angeles (UCLA) Los Angeles CA USA.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Labus', 'Affiliation': 'G Oppenheimer Center for Neurobiology of Stress and Resilience, Ingestive Behavior & Obesity Program UCLA Los Angeles CA USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sanmiguel', 'Affiliation': 'G Oppenheimer Center for Neurobiology of Stress and Resilience, Ingestive Behavior & Obesity Program UCLA Los Angeles CA USA.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Mayer', 'Affiliation': 'G Oppenheimer Center for Neurobiology of Stress and Resilience, Ingestive Behavior & Obesity Program UCLA Los Angeles CA USA.'}]",Obesity science & practice,['10.1002/osp4.124']
190,32289541,Online Education Is Non-Inferior to Group Education for Irritable Bowel Syndrome: A Randomized Trial and Patient Preference Trial.,"BACKGROUND & AIMS


Structured education can reduce symptoms in patients with irritable bowel syndrome (IBS), but the availability of such interventions is limited and online formats could facilitate their dissemination. We compared the effectiveness of Internet-delivered vs face-to-face education in patients with IBS, hypothesizing that the online format would not be inferior.
METHODS


We conducted 2 trials of Internet-delivered vs face-to-face group education (3 weeks) at a gastroenterology outpatient clinic in Sweden. In the first trial, 141 patients with IBS were assigned randomly (1:1) to either Internet-delivered or face-to-face education, from August 2016 through June 2017. In the second trial, 155 patients with IBS were allowed to choose whether to receive education via the Internet or face to face, from August 2017 through September 2018. Patients completed questionnaires before, during, and after education. The primary outcome measure was the irritable bowel syndrome severity scoring system, which measures IBS severity on a scale from 0 to 500, based on abdominal pain, bloating, dissatisfaction with bowel habits, and interference with life. The primary test of noninferiority adhered to the intent-to-treat principle and concerned the difference in change up to 6 months after education, tested using the 1-sided CI for the time by group interaction in a linear mixed model fitted on data from the randomized controlled trial. A secondary per-protocol analysis used data from all treatment completers in both trials. The noninferiority margin was 40 points on the irritable bowel syndrome severity scoring system.
RESULTS


In the primary analysis, patients who received face-to-face education had an average reduction in irritable bowel syndrome severity score that was 12.2 points more than that of patients who received Internet education (1-sided 95% CI upper bound, 38.4). In the per-protocol analysis, patients who received face-to-face education reduced their average irritable bowel syndrome severity score by 14.7 points more than patients who received Internet education (95% CI upper bound, 35.5). Face-to-face education had significantly higher credibility and produced a significantly larger increase in self-rated knowledge, although most patients preferred Internet-delivered education. Between-group effects on secondary symptoms were small.
CONCLUSIONS


Based on the comparison of Internet-delivered vs face-to-face education for IBS, the upper bound of the CI for the difference in change up to 6 months after education was within the noninferiority margin of 40 points. We therefore conclude that Internet-delivered education is noninferior to face-to-face education. Future research should focus on increasing within-group effects. ClinicalTrials.gov no: NCT03466281.",2020,"Face to face education had significantly higher credibility and produced a significantly larger increase in self-rated knowledge, although most patients preferred internet-delivered education.","['patients with irritable bowel syndrome (IBS', '155 patients with IBS', '3 weeks) at a gastroenterology outpatient clinic in Sweden', '141 patients with IBS', 'Irritable Bowel Syndrome', 'patients with IBS']","['internet-delivered vs face to face group education', 'internet-delivered or face to face education', 'internet-delivered vs face to face education']","['irritable bowel severity score', 'irritable bowel severity scoring system, which measures IBS severity on a scale from 0 to 500, based on abdominal pain, bloating, dissatisfaction with bowel habits, and interference with life', 'self-rated knowledge', 'average irritable bowel severity score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C4517572', 'cui_str': '141'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",141.0,0.112174,"Face to face education had significantly higher credibility and produced a significantly larger increase in self-rated knowledge, although most patients preferred internet-delivered education.","[{'ForeName': 'Perjohan', 'Initials': 'P', 'LastName': 'Lindfors', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Department of Gastroenterology, Sollentuna Specialistklinik, Stockholm, Sweden. Electronic address: perjohan.lindfors@ki.se.'}, {'ForeName': 'Erland', 'Initials': 'E', 'LastName': 'Axelsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Engstrand', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Störsrud', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Pernilla', 'Initials': 'P', 'LastName': 'Jerlstad', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Törnblom', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Simrén', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Centre for Functional Gastrointestinal and Motility Disorders, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Ringström', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.04.005']
191,31612956,Cannabis and Alcohol Co-Use in a Smoking Cessation Pharmacotherapy Trial for Adolescents and Emerging Adults.,"INTRODUCTION


The co-use of cannabis and alcohol among tobacco-using youth is common. Alcohol co-use is associated with worse tobacco cessation outcomes, but results are mixed regarding the impact of cannabis on tobacco outcomes and if co-use leads to increased use of non-treated substances. This secondary analysis from a youth smoking cessation trial aimed to (1) evaluate the impact of cannabis or alcohol co-use on smoking cessation, (2) examine changes in co-use during the trial, and (3) explore secondary effects of varenicline on co-use.
METHODS


The parent study was a 12-week, randomized clinical trial of varenicline for smoking cessation among youth (ages 14-21, N = 157; Mage = 19, 40% female; 76% White). Daily cigarette, cannabis, and alcohol use data were collected via daily diaries during treatment and Timeline Follow-back for 14 weeks post-treatment.
RESULTS


Baseline cannabis co-users (68%) had double the odds of continued cigarette smoking throughout the trial compared with noncannabis users, which was pronounced in males and frequent cannabis users. Continued smoking during treatment was associated with higher probability of concurrent cannabis use. Baseline alcohol co-users (80%) did not have worse smoking outcomes compared with nonalcohol users, but continued smoking was associated with higher probability of concurrent drinking. Varenicline did not affect co-use.
CONCLUSIONS


Inconsistent with prior literature, results showed that alcohol co-users did not differ in smoking cessation, whereas cannabis co-users had poorer cessation outcomes. Youth tobacco treatment would benefit from added focus on substance co-use, particularly cannabis, but may need to be tailored appropriately to promote cessation.
IMPLICATIONS


Among youth cigarette smokers enrolled in a pharmacotherapy evaluation clinical trial, alcohol and/or cannabis co-use was prevalent. The co-use of cannabis affected smoking cessation outcomes, but more so for males and frequent cannabis users, whereas alcohol co-use did not affect smoking cessation. Reductions in smoking were accompanied by concurrent reductions in alcohol or cannabis use. Substance co-use does not appear to affect all youth smokers in the same manner and treatment strategies may need to be tailored appropriately for those with lower odds of smoking cessation.",2020,"The co-use of cannabis affected smoking cessation outcomes, but more so for males and frequent cannabis users, whereas alcohol co-use did not affect smoking cessation.","['youth cigarette smokers', 'Adolescents and Emerging Adults', 'smoking cessation among youth (ages 14-21, N = 157; Mage = 19, 40% female; 76% White']","['varenicline', 'cannabis or alcohol co-use', 'Varenicline']",['cigarette smoking'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}]",,0.0318818,"The co-use of cannabis affected smoking cessation outcomes, but more so for males and frequent cannabis users, whereas alcohol co-use did not affect smoking cessation.","[{'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Caitlyn O', 'Initials': 'CO', 'LastName': 'Hood', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Tomko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Squeglia', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz170']
192,32227753,Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease.,"BACKGROUND


In the ISCHEMIA trial, an invasive strategy with angiographic assessment and revascularization did not reduce clinical events among patients with stable ischemic heart disease and moderate or severe ischemia. A secondary objective of the trial was to assess angina-related health status among these patients.
METHODS


We assessed angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ) at randomization, at months 1.5, 3, and 6, and every 6 months thereafter in participants who had been randomly assigned to an invasive treatment strategy (2295 participants) or a conservative strategy (2322). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate differences between the treatment groups. The primary outcome of this health-status analysis was the SAQ summary score (scores range from 0 to 100, with higher scores indicating better health status). All analyses were performed in the overall population and according to baseline angina frequency.
RESULTS


At baseline, 35% of patients reported having no angina in the previous month. SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy. Differences were larger among participants who had more frequent angina at baseline (8.5 vs. 0.1 points at 3 months and 5.3 vs. 1.2 points at 36 months among participants with daily or weekly angina as compared with no angina).
CONCLUSIONS


In the overall trial population with moderate or severe ischemia, which included 35% of participants without angina at baseline, patients randomly assigned to the invasive strategy had greater improvement in angina-related health status than those assigned to the conservative strategy. The modest mean differences favoring the invasive strategy in the overall group reflected minimal differences among asymptomatic patients and larger differences among patients who had had angina at baseline. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).",2020,"SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy.","['Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease', 'patients with stable ischemic heart disease and moderate or severe ischemia']",['invasive treatment strategy (2295 participants) or a conservative strategy'],"['angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ', 'SAQ summary score (scores range', 'SAQ summary scores', 'angina-related health status']","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]",,0.248293,"SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy.","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Jones', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Harrell', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Weintraub', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Khaula', 'Initials': 'K', 'LastName': 'Baloch', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Kreton', 'Initials': 'K', 'LastName': 'Mavromatis', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Diaz', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Gosselin', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Mavromichalis', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916370']
193,32289193,Well-Being Therapy as Rehabilitation Therapy for Posttraumatic Stress Disorder Symptoms: A Randomized Controlled Trial.,"Many individuals with posttraumatic stress disorder (PTSD) continue to have substantial residual symptoms after completing psychological treatment. Well-being therapy (WBT) has been developed to treat the residual phase of mental disorders, prevent relapse, and promote a full recovery. The present study aimed to compare treatment as usual (TAU) with the long-term effects of WBT as a rehabilitation therapy in adults who successfully completed psychological treatment for PTSD. Participants who did not meet PTSD diagnostic criteria after completing treatment were randomized to WBT (n = 29) or TAU (n = 35) groups. Assessments of well-being, residual PTSD symptoms, and posttraumatic growth were conducted at baseline (T0) and again after 3 months (T1), 6 months (T2), and 1 year (T3). The results of the multilevel analysis revealed that WBT was not more effective than TAU in increasing levels of well-being, γ = 0.02 (SE = 0.11) or posttraumatic growth, γ = 0.10 (SE = 0.13) nor in decreasing PTSD symptoms, γ = -0.04 (SE = 0.05). However, for participants with low levels of well-being at baseline (Mental Health Continuum-Short Form score < 2.6), WBT was more effective than TAU in increasing ratings of well-being, γ = -0.41 (SE = 0.19) and posttraumatic growth, γ = -0.55 (SE = 0.24); this effect was most evident at T3 for posttraumatic growth, d = 1.23. Future research should assess clinically relevant individual characteristics that to optimize the effectiveness and utility of WBT.",2020,"The results of the multilevel analysis revealed that WBT was not more effective than TAU in increasing levels of well-being, γ = 0.02 (SE = 0.11) or posttraumatic growth, γ = 0.10 (SE = 0.13) nor in decreasing PTSD symptoms, γ = -0.04 (SE = 0.05).","['Participants who did not meet PTSD diagnostic criteria after completing treatment', 'individuals with posttraumatic stress disorder (PTSD', 'adults who successfully completed psychological treatment for PTSD', 'Posttraumatic Stress Disorder Symptoms']","['TAU', 'Well-being therapy (WBT', 'WBT']","['PTSD symptoms', 'Assessments of well-being, residual PTSD symptoms, and posttraumatic growth']","[{'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}]",,0.0451418,"The results of the multilevel analysis revealed that WBT was not more effective than TAU in increasing levels of well-being, γ = 0.02 (SE = 0.11) or posttraumatic growth, γ = 0.10 (SE = 0.13) nor in decreasing PTSD symptoms, γ = -0.04 (SE = 0.05).","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Radstaak', 'Affiliation': 'Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hüning', 'Affiliation': 'Mediant, Community Mental Health Center, Enschede, The Netherlands.'}, {'ForeName': 'Ernst T', 'Initials': 'ET', 'LastName': 'Bohlmeijer', 'Affiliation': 'Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands.'}]",Journal of traumatic stress,['10.1002/jts.22500']
194,32170727,Smoking cessation prior to gynecological surgery-A registry-based randomized trial.,"INTRODUCTION


Smoking cessation, both pre- and postoperatively, is important to reduce complications associated with surgery. Identifying feasible and effective means of alerting the patient before surgery to the importance of perioperative smoking cessation is a challenge to healthcare systems.
MATERIAL AND METHODS


A randomized registry-based trial using the web-version of the Swedish national quality register for gynecological surgery, GynOp, was performed (ClinicalTrials.gov NCT03942146). Current smokers scheduled for gynecological surgery were randomly assigned before surgery to group 1 (control group, no specific information), group 2 (web-based written information), group 3 (information to doctor that the woman was a smoker and should be recommended smoking cessation or group 4 (a combination of groups 2 and 3). Perioperative smoking habits were evaluated in a postoperative questionnaire 2 months after surgery. The treatment effect was estimated to be a 15% reduction in the number of smokers at the time of surgery. Thus, 94 women in each group were required, in total 376 women, using a one-sided test with an alpha level of 0.001 and a statistical power of 80%.
RESULTS


Participants (n = 1427) were recruited between 5 November 2015 and 6 December 2017. A total of 1137 smokers responded to the follow-up questionnaire (80%), with 486 women declining to participate, leaving 651 women eligible for analysis. Women who received both web-based information prior to surgery and information from a doctor, reported smoking cessation more often from 1 to 3 weeks preoperatively (Odds ratio [OR] 1.8, 95% confidence interval [CI] 1.0-3.3) and 1 to 3 weeks after surgery (OR 1.9, 95% CI 1.1-3.3) compared with the control group who received no specific information.
CONCLUSIONS


A combination of written information in the health declaration and a recommendation from a doctor regarding smoking cessation may be associated with higher odds of smoking cessation at 1-3 weeks pre- and postoperatively.",2020,"Women who received both web-based information prior to surgery and information from a doctor reported smoking cessation more often from 1-3 weeks preoperatively (Odds ratio, 95% confidence interval 1.8 [1.0-3.3]) and 1-3 weeks after surgery (1.9 [1.1-3.3]) compared to the control group who received no specific information.
","['1137 smokers responded to the follow-up questionnaire (80%) and 486 women declined participation leaving 651 women eligible for analysis', '94 women in each group were required, in total 376 women, using a one-sided test with an alfa level of 0.001 and a statistical power of 80', 'Current smokers scheduled for gynecological surgery', 'Participants (n = 1427) were recruited between November 5, 2015, and December 6, 2017']","['control group, no specific information, Group 2, web-based written information, Group 3, information to doctor that the woman was a smoker and should be recommended smoking cessation', 'Smoking cessation prior to gynecological surgery']","['smoking cessation', 'Perioperative smoking habits']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4517385', 'cui_str': '0.001 (qualifier value)'}, {'cui': 'C3241966'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C4505437', 'cui_str': 'Smoking Habit'}]",1427.0,0.0572988,"Women who received both web-based information prior to surgery and information from a doctor reported smoking cessation more often from 1-3 weeks preoperatively (Odds ratio, 95% confidence interval 1.8 [1.0-3.3]) and 1-3 weeks after surgery (1.9 [1.1-3.3]) compared to the control group who received no specific information.
","[{'ForeName': 'Katja S', 'Initials': 'KS', 'LastName': 'Bohlin', 'Affiliation': 'Department of Obstetrics and Gynecology, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Löfgren', 'Affiliation': 'Department of Obstetrics and Gynecology, Umeå University Hospital, Umeå, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Lindkvist', 'Affiliation': 'Department of Mathematics and Mathematical Statistics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Milsom', 'Affiliation': 'Department of Obstetrics and Gynecology, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13843']
195,32283854,Effects of an Acute Pilates Program under Hypoxic Conditions on Vascular Endothelial Function in Pilates Participants: A Randomized Crossover Trial.,"This study aimed to compare the effects of an acute Pilates program under hypoxic vs. normoxic conditions on the metabolic, cardiac, and vascular functions of the participants. Ten healthy female Pilates experts completed a 50-min tubing Pilates program under normoxic conditions (N trial) and under 3000 m (inspired oxygen fraction = 14.5%) hypobaric hypoxia conditions (H trial) after a 30-min exposure in the respective environments on different days. Blood pressure, branchial ankle pulse wave velocity, and flow-mediated dilation (FMD) in the branchial artery were measured before and after the exercise. Metabolic parameters and cardiac function were assessed every minute during the exercise. Both trials showed a significant increase in FMD; however, the increase in FMD was significantly higher after the H trial than that after the N trial. Furthermore, FMD before exercise was significantly higher in the H trial than in the N trial. In terms of metabolic parameters, minute ventilation, carbon dioxide excretion, respiratory exchange ratio, and carbohydrate oxidation were significantly higher but fat oxidation was lower during the H trial than during the N trial. In terms of cardiac function, heart rate was significantly increased during the H trial than during the N trial. Our results suggested that, compared to that under normoxic conditions, Pilates exercise under hypoxic conditions led to greater metabolic and cardiac responses and also elicited an additive effect on vascular endothelial function.",2020,"In terms of metabolic parameters, minute ventilation, carbon dioxide excretion, respiratory exchange ratio, and carbohydrate oxidation were significantly higher but fat oxidation was lower during the H trial than during the N trial.","['Ten healthy female Pilates experts', 'Pilates Participants']","['acute Pilates program under hypoxic vs. normoxic conditions', '50-min tubing Pilates program under normoxic conditions (N trial) and under 3000 m (inspired oxygen fraction = 14.5%) hypobaric hypoxia conditions', 'Acute Pilates Program under Hypoxic Conditions']","['cardiac function, heart rate', 'Vascular Endothelial Function', 'metabolic and cardiac responses', 'vascular endothelial function', 'metabolic parameters, minute ventilation, carbon dioxide excretion, respiratory exchange ratio, and carbohydrate oxidation', 'FMD', 'FMD before exercise', 'Blood pressure, branchial ankle pulse wave velocity, and flow-mediated dilation (FMD', 'Metabolic parameters and cardiac function', 'metabolic, cardiac, and vascular functions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C4552489', 'cui_str': 'Hypobaric hypoxia'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0585043', 'cui_str': 'Before exercise'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",10.0,0.0934485,"In terms of metabolic parameters, minute ventilation, carbon dioxide excretion, respiratory exchange ratio, and carbohydrate oxidation were significantly higher but fat oxidation was lower during the H trial than during the N trial.","[{'ForeName': 'Kyounghwa', 'Initials': 'K', 'LastName': 'Jung', 'Affiliation': 'Department of Physical Education, Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Jongbeom', 'Initials': 'J', 'LastName': 'Seo', 'Affiliation': 'Department of Physical Education, Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Won-Sang', 'Initials': 'WS', 'LastName': 'Jung', 'Affiliation': 'Physical Activity and Performance Institute (PAPI), Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Jisu', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Physical Activity and Performance Institute (PAPI), Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Hun-Young', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Physical Activity and Performance Institute (PAPI), Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Kiwon', 'Initials': 'K', 'LastName': 'Lim', 'Affiliation': 'Department of Physical Education, Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17072584']
196,32285238,"Implementation, feasibility, and acceptability of quality of life therapy to improve positive emotions among patients with implantable cardioverter defibrillators.","Implantable cardioverter defibrillators (ICDs) save lives, but often induce significant psychological distress among patients. Positive psychological constructs are associated with improved outcomes among cardiac patients. In this NHLBI-funded randomized controlled trial, one aim was to evaluate the feasibility and acceptability of a positive psychology intervention (Quality of Life Therapy; QOLT, n = 11), compared to a Heart Healthy Education (HHE) control (n = 10), among ICD patients. A majority of participants across groups attended all 12 sessions (71%) and completed homework assignments (80%). Agreement on participant engagement and interventionist protocol adherence were high, with no differences between groups (ps > 0.20). A greater proportion of QOLT participants rated their sessions was ""very"" helpful compared to HHE participants (63% vs. 10%, p = 0.19). These initial data support the feasibility and acceptability of QOLT. A larger-scale trial using positive psychology interventions among ICD patients is indicated to determine potential mechanisms underlying the relationship between positive psychological constructs and cardiovascular health.",2020,"Agreement on participant engagement and interventionist protocol adherence were high, with no differences between groups (ps > 0.20).","['ICD patients', 'patients with implantable cardioverter defibrillators', ' n\u2009=\u200911), compared to a Heart Healthy Education (HHE) control (n\u2009=\u200910), among ICD patients']","['positive psychology intervention (Quality of Life Therapy; QOLT', 'Implantable cardioverter defibrillators (ICDs', 'positive psychology interventions']","['participant engagement and interventionist protocol adherence', 'positive emotions', 'feasibility and acceptability']","[{'cui': 'C0020725', 'cui_str': 'I-cell disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",1.0,0.071956,"Agreement on participant engagement and interventionist protocol adherence were high, with no differences between groups (ps > 0.20).","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Carroll', 'Affiliation': 'Division of Bio-Behavioral Medicine, Medical University of South Carolina, 67 President Street, MSC 861, Charleston, SC, 29425, USA.'}, {'ForeName': 'Lillian M', 'Initials': 'LM', 'LastName': 'Christon', 'Affiliation': 'Division of Bio-Behavioral Medicine, Medical University of South Carolina, 67 President Street, MSC 861, Charleston, SC, 29425, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Rodrigue', 'Affiliation': 'Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Fava', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Providence, RI, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Frisch', 'Affiliation': 'Baylor University, Waco, TX, USA.'}, {'ForeName': 'Eva R', 'Initials': 'ER', 'LastName': 'Serber', 'Affiliation': 'Division of Bio-Behavioral Medicine, Medical University of South Carolina, 67 President Street, MSC 861, Charleston, SC, 29425, USA. serbere@musc.edu.'}]",Journal of behavioral medicine,['10.1007/s10865-020-00153-2']
197,32285242,"Tracking Time and Resources Associated with Systems Change and the Adoption of Evidence-Based Programs: The ""Hidden Costs"" of School-Based Coaching.","This study leveraged data from a 40-school randomized controlled trial to understand the cost of coaching to support implementation of evidence-based programs (EBPs) through a multi-tiered system of supports for behavior (MTSS-B) model. Coach activity log data were utilized to generate the annual average, per school, costs of coaching of $8198. The cost of school personnel time for coaching was estimated to be $3028. Data on coach-rated administrator buy-in, school MTSS-B engagement, and implementation infrastructure and capacity were also collected and found to be associated with coaching activities. Notably, coaches did not spend significantly different amounts of time in schools using few EBPs relative to more EBPs, indicating some inefficiency in the use of coaches' time. These findings highlight the often-overlooked resources needed to support EBP implementation in schools.",2020,"Notably, coaches did not spend significantly different amounts of time in schools using few EBPs relative to more EBPs, indicating some inefficiency in the use of coaches' time.",[],['coaching to support implementation of evidence-based programs (EBPs'],['cost of school personnel time for coaching'],[],"[{'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0297343,"Notably, coaches did not spend significantly different amounts of time in schools using few EBPs relative to more EBPs, indicating some inefficiency in the use of coaches' time.","[{'ForeName': 'Elise T', 'Initials': 'ET', 'LastName': 'Pas', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University, 415 N. Washington Street, Baltimore, MD, 21231, USA. epas@jhu.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lindstrom Johnson', 'Affiliation': 'T. Denny Sanford School of Social and Family Dynamics, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Y Natalia', 'Initials': 'YN', 'LastName': 'Alfonso', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University, 415 N. Washington Street, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Catherine P', 'Initials': 'CP', 'LastName': 'Bradshaw', 'Affiliation': 'Curry School of Education and Human Development, University of Virginia, Charlottesville, VA, USA.'}]",Administration and policy in mental health,['10.1007/s10488-020-01039-w']
198,32241780,A  Post Hoc  Analysis of Statin Use in Tolvaptan Autosomal Dominant Polycystic Kidney Disease Pivotal Trials.,"BACKGROUND AND OBJECTIVES


Tolvaptan is approved to slow kidney function decline in adults with autosomal dominant polycystic kidney disease (ADPKD) at risk of rapid progression. Because  in vitro  studies indicated that the tolvaptan oxobutyric acid metabolite inhibits organic anion-transporting polypeptide (OATP)1B1 and OATP1B3, United States prescribing information advises avoiding concurrent use with OATP1B1/1B3 substrates, including hepatic hydroxymethyl glutaryl-CoA reductase inhibitors (statins). This  post hoc  analysis of the pivotal phase 3 tolvaptan trials (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes [TEMPO] 3:4 trial [NCT00428948] and Replicating Evidence of Preserved Renal Function: an Investigation of Tolvaptan Safety and Efficacy in ADPKD [REPRISE] trial [NCT02160145]) examined the safety of concurrent tolvaptan/statin use.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


The trials randomized a combined total of 2815 subjects with early- to late-stage ADPKD to tolvaptan ( n =1644) or placebo ( n =1171) for 3 years (TEMPO 3:4) and 1 year (REPRISE). Statin use was unrestricted, and 597 subjects (21.2% overall; 332 [20.2%] tolvaptan, 265 [22.6%] placebo) received statins. Statin use (duration, dose change, statin change, permanent discontinuation), incidences of statin-related adverse events, and hepatic transaminase elevations were determined for subjects who received tolvaptan+statin, placebo+statin, tolvaptan alone, and placebo alone.
RESULTS


No differences in statin use parameters between tolvaptan- and placebo-treated subjects were observed. No statistically significant increases in commonly reported statin-related adverse events ( e.g. , musculoskeletal disorders, gastrointestinal symptoms) were seen between subjects receiving tolvaptan+statin and placebo+statin. For example, in TEMPO 3:4, frequencies were 5.4% and 7.8%, respectively, for myalgia (difference -2.4%; 95% confidence interval, -11.2% to 6.4%) and 9.3% and 7.8%, respectively, for abdominal pain (difference 1.5%; -7.9% to 10.9%). In an analysis that excluded participants concurrently using allopurinol, the frequency of alanine transaminase or aspartate transaminase >3× upper limit of normal in the pooled study populations was 3.6% for the tolvaptan+statin group and 2.3% for the placebo+statin group (difference 1.4%; -2.0% to 4.7%).
CONCLUSIONS


Tolvaptan has been used safely in combination with statins in clinical trials.
PODCAST


This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2020_04_06_CJN.08170719.mp3.",2020,"No statistically significant increases in commonly reported statin-related adverse events ( e.g. , musculoskeletal disorders, gastrointestinal symptoms) were seen between subjects receiving tolvaptan+statin and placebo+statin.","['2815 subjects with early- to late-stage ADPKD to tolvaptan ( n =1644) or', 'adults with autosomal dominant polycystic kidney disease (ADPKD) at risk of rapid progression', ' n =1171) for 3 years (TEMPO 3:4) and 1 year (REPRISE']","['tolvaptan- and placebo', 'placebo+statin', 'tolvaptan+statin, placebo+statin, tolvaptan alone, and placebo', 'placebo', 'allopurinol', 'Tolvaptan']","['myalgia', 'statin-related adverse events ( e.g. , musculoskeletal disorders, gastrointestinal symptoms', 'Statin use (duration, dose change, statin change, permanent discontinuation), incidences of statin-related adverse events, and hepatic transaminase elevations', 'frequency of alanine transaminase or aspartate transaminase >3× upper limit of normal', 'abdominal pain']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0085413', 'cui_str': 'Autosomal dominant polycystic kidney disease'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}]","[{'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}]","[{'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}]",2815.0,0.269788,"No statistically significant increases in commonly reported statin-related adverse events ( e.g. , musculoskeletal disorders, gastrointestinal symptoms) were seen between subjects receiving tolvaptan+statin and placebo+statin.","[{'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Shoaf', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland susan.shoaf@otsuka-us.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ouyang', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Sergeyeva', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Estilo', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Leung', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.08170719']
199,32284181,Effect of probiotics on gut microbiome in patients with administration of surgical antibiotic prophylaxis: A randomized controlled study.,"Surgical antibiotic prophylaxis (SAP) is recommended for the prevention of surgical site infections. However, there is a concern about adverse effects of SAP, such as antibiotic-associated diarrhea (AAD). To prevent AAD, administration of probiotics has been investigated. Although recent advances in next-generation sequencing makes it possible to analyze the gut microbiome, the effect of probiotics on the gut microbiome in the patients with SAP remains unknown. To test a hypothesis that SAP influences the gut microbiome and probiotics prevent the influence, a randomized controlled study was conducted with patients who underwent spinal surgery at Nagasaki University Hospital. After obtaining informed consent, the patients were automatically classified into the non-probiotics group and the probiotics group. In the probiotics group, the patients took 1 g of Enterococcus faecium 129 BIO 3B-R, 3 times a day on postoperative days (PODs) 1-5. The feces of all patients were sampled before administration of SAP and on PODs 5 and 10. We compared alpha and beta diversity and differential abundance analysis of the gut microbiome before and after SAP. During the study period, a total of 33 patients were evaluated, comprising 17 patients in the non-probiotics group and 16 in the probiotics group. There was no significant difference between the groups regarding patient characteristics. In alpha and beta diversity, there were no significant differences among all combinations. In differential abundance analysis at operational taxonomic unit level, Streptococcus gallolyticus and Roseburia were significantly increased in the non-probiotics group and significantly decreased in the probiotics group.",2020,"In differential abundance analysis at operational taxonomic unit level, Streptococcus gallolyticus and Roseburia were significantly increased in the non-probiotics group and significantly decreased in the probiotics group.","['33 patients were evaluated, comprising 17 patients in the non-probiotics group and 16 in the probiotics group', 'patients with administration of surgical antibiotic prophylaxis', 'patients who underwent spinal surgery at Nagasaki University Hospital']","['probiotics', 'Surgical antibiotic prophylaxis (SAP']","['operational taxonomic unit level, Streptococcus gallolyticus and Roseburia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}]","[{'cui': 'C0008903', 'cui_str': 'classification'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1017328', 'cui_str': 'Streptococcus gallolyticus'}, {'cui': 'C0995401', 'cui_str': 'Roseburia'}]",33.0,0.0277709,"In differential abundance analysis at operational taxonomic unit level, Streptococcus gallolyticus and Roseburia were significantly increased in the non-probiotics group and significantly decreased in the probiotics group.","[{'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Kaku', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan; Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. Electronic address: kaku-ngs@umin.ac.jp.'}, {'ForeName': 'Nariyoshi', 'Initials': 'N', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sasaki', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Tsuda', 'Affiliation': 'Department of Orthopaedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kosai', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan; Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Uno', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan; Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Yoshitomo', 'Initials': 'Y', 'LastName': 'Morinaga', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan; Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tagami', 'Affiliation': 'Department of Orthopaedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Adachi', 'Affiliation': 'Department of Orthopaedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Hiroo', 'Initials': 'H', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan; Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Osaki', 'Affiliation': 'Department of Orthopaedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Yanagihara', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan; Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}]",Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy,['10.1016/j.jiac.2020.03.008']
200,31376386,"Impact of intervention on nutritional status, consumption of processed foods, and quality of life of adolescents with excess weight.","OBJECTIVE


To evaluate the impact of a nutritional intervention on nutritional status, ultra-processed food consumption, and quality of life of adolescents with excess weight.
METHODS


Experimental study with adolescent students with excess weight, divided into two groups, an intervention group and a control group. The nutritional intervention lasted six months, with an educational and motivational approach. Nutritional status (waist circumference and body mass index), quality of life, and ultra-processed food consumption were evaluated before and after the period.
RESULTS


Sixty-two adolescents with overweight or obesity participated in the study, 37 in the intervention group and 25 in the control group, aged 13.2±1.5 years in intervention group, and 13.0±1.8 years in control group, both of which had a higher female participation. There were changes in the body mass index (intervention group Δ: -0.81±2.28, control group Δ: -0.64±1.28) and in the waist circumference for intervention group (Δ:-3.31±5.47). For the pre- and post-ultra-processed food consumption, there was a significant reduction in the consumption of soft drinks in the intervention group (Δ: -0.07 [-0.27 to 0.00]), instant noodles (Δ: -0.03 [-0.07 to 0.00]), and sandwich cookies (Δ: -0.06 [-0.26 to 0.00]). The quality of life increased in the intervention group and decreased in the control group, with no intra- (p=0.162) or intergroup statistical relevance in the pre- (p=0.426) and post- (0.249) intervention period, with a reduction in the emotional domain score, with a significant variation in the intervention group (pre and post; Δ: -19.0±40.6).
CONCLUSION


There was a decrease in body mass index and waist circumference (central obesity being more often related to insulin resistance), reduction of ultra-processed food consumption (soft drinks, sandwich cookies, and instant noodles), and a tendency toward quality of life improvement (however, there was a decrease in the domains of emotional and school quality of life).",2020,"The quality of life increased in the intervention group and decreased in the control group, with no intra-","['Sixty-two adolescents with overweight or obesity participated in the study, 37 in the intervention group and 25 in the control group, aged 13.2±1.5 years in intervention group, and 13.0±1.8 years in control group, both of which had a higher female participation', 'Experimental study with adolescent students with excess weight', 'adolescents with excess weight']",['nutritional intervention'],"['Nutritional status (waist circumference and body mass index), quality of life, and ultra-processed food consumption', 'nutritional status, consumption of processed foods, and quality of life', 'body mass index and waist circumference (central obesity', 'consumption of soft drinks', 'quality of life', 'body mass index', 'nutritional status, ultra-processed food consumption, and quality of life', 'domains of emotional and school quality of life']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",[],"[{'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0034380'}, {'cui': 'C0344355', 'cui_str': 'Convenience Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C4551560', 'cui_str': 'Central obesity (disorder)'}, {'cui': 'C3489624', 'cui_str': 'Soft Drinks'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]",62.0,0.020214,"The quality of life increased in the intervention group and decreased in the control group, with no intra-","[{'ForeName': 'Fabiana A', 'Initials': 'FA', 'LastName': 'Poll', 'Affiliation': 'Universidade de Santa Cruz do Sul (UNISC), Departamento de Educação Física e Saúde, Santa Cruz do Sul, RS, Brazil.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Miraglia', 'Affiliation': 'Universidade La Salle (UNILASALLE), Programa de Pós-Graduação em Saúde e Desenvolvimento Humano e Graduação em Nutrição, Canoas, RS, Brazil.'}, {'ForeName': 'Helen F', 'Initials': 'HF', 'LastName': ""D'avila"", 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Programa de Pós-Graduação da Saúde da Criança e do Adolescente, Porto Alegre, RS, Brazil. Electronic address: helen14davila@hotmail.com.'}, {'ForeName': 'Cézane P', 'Initials': 'CP', 'LastName': 'Reuter', 'Affiliation': 'Universidade de Santa Cruz do Sul (UNISC), Departamento de Educação Física e Saúde, Santa Cruz do Sul, RS, Brazil.'}, {'ForeName': 'Elza D', 'Initials': 'ED', 'LastName': 'Mello', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Programa de Pós-Graduação da Saúde da Criança e do Adolescente, Porto Alegre, RS, Brazil.'}]",Jornal de pediatria,['10.1016/j.jped.2019.05.007']
201,32284323,Metabolic Disorders with Kidney Transplant.,"Metabolic disorders are highly prevalent in kidney transplant candidates and recipients and can adversely affect post-transplant graft outcomes. Management of diabetes, hyperparathyroidism, and obesity presents distinct opportunities to optimize patients both before and after transplant as well as the ability to track objective data over time to assess a patient's ability to partner effectively with the health care team and adhere to complex treatment regimens. Optimization of these particular disorders can most dramatically decrease the risk of surgical and cardiovascular complications post-transplant. Approximately 60% of nondiabetic patients experience hyperglycemia in the immediate post-transplant phase. Multiple risk factors have been identified related to development of new onset diabetes after transplant, and it is estimated that upward of 7%-30% of patients will develop new onset diabetes within the first year post-transplant. There are a number of medications studied in the kidney transplant population for diabetes management, and recent data and the risks and benefits of each regimen should be optimized. Secondary hyperparathyroidism occurs in most patients with CKD and can persist after kidney transplant in up to 66% of patients, despite an initial decrease in parathyroid hormone levels. Parathyroidectomy and medical management are the options for treatment of secondary hyperparathyroidism, but there is no randomized, controlled trial providing clear recommendations for optimal management, and patient-specific factors should be considered. Obesity is the most common metabolic disorder affecting the transplant population in both the pre- and post-transplant phases of care. Not only does obesity have associations and interactions with comorbid illnesses, such as diabetes, dyslipidemia, and cardiovascular disease, all of which increase morbidity and mortality post-transplant, but it also is intimately inter-related with access to transplantation for patients with kidney failure. We review these metabolic disorders and their management, including data in patients with kidney transplants.",2020,Obesity is the most common metabolic disorder affecting the transplant population in both the pre- and post-transplant phases of care.,"['Metabolic Disorders with Kidney Transplant', 'patients with kidney failure', 'patients with kidney transplants']",[],['parathyroid hormone levels'],"[{'cui': 'C0025517', 'cui_str': 'Metabolic disease'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}]",[],"[{'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement'}]",,0.0213202,Obesity is the most common metabolic disorder affecting the transplant population in both the pre- and post-transplant phases of care.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cohen', 'Affiliation': 'Department of Pharmacy, Yale-New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Korah', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Callender', 'Affiliation': 'Department of Surgery, Section of Endocrine Surgery, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Belfort de Aguiar', 'Affiliation': 'Department of Medicine, Section of Endocrinology, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Haakinson', 'Affiliation': 'Department of Surgery, Section of Transplant, Yale University, New Haven, Connecticut danielle.haakinson@yale.edu.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.09310819']
202,31345563,Predicting Outcomes After Distal Radius Fracture: A 24-Center International Clinical Trial of Older Adults.,"PURPOSE


Current evidence on predictors of outcomes after distal radius fracture is often based on retrospective analyses or may be confounded by fracture type. Using data from the Wrist and Radius Injury Surgical Trial (WRIST), a 24-site randomized study of distal radius fracture treatment, in which all fractures are severe enough to warrant surgery, we set out to perform a secondary data analysis to explore predictors of better or worse hand outcomes.
METHODS


The primary outcome measure was the Michigan Hand Outcomes Questionnaire (MHQ) summary score 12 months after treatment. We used a regression tree analysis with recursive partitioning to identify subgroups of participants who experienced similar outcomes (ie, MHQ score) and to determine which baseline or treatment factors they had in common.
RESULTS


Factors most predictive of 12-month MHQ score were pain at enrollment, education, age, and number of comorbidities. Specifically, participants who had a high school education or less and also reported severe pain had the lowest MHQ scores. Conversely, participants with less pain and more education and who were age 87 years or younger with one or no comorbid condition had the highest MHQ scores. Treatment type or radiographic measurements assessed on post-reduction films did not affect 12-month outcomes.
CONCLUSIONS


These results identified patient characteristics that can be used by surgeons to identify subgroups of patients who may experience similar hand outcomes.
TYPE OF STUDY/LEVEL OF EVIDENCE


Prognostic III.",2019,"Treatment type or radiographic measurements assessed on post-reduction films did not affect 12-month outcomes.
","['participants with less pain and more education and who were age 87 years or younger with one or no comorbid condition', 'Older Adults', 'participants who had a high school education or less and also reported', 'After Distal Radius Fracture']",['distal radius fracture treatment'],"['highest MHQ scores', 'Michigan Hand Outcomes Questionnaire (MHQ) summary score 12 months', 'severe pain']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1275743', 'cui_str': 'Comorbid conditions'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]","[{'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0919720', 'cui_str': 'Fracture treatment'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}]",,0.155674,"Treatment type or radiographic measurements assessed on post-reduction films did not affect 12-month outcomes.
","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Chung', 'Affiliation': 'Section of Plastic Surgery, Department of Surgery. Electronic address: kecchung@med.umich.edu.'}, {'ForeName': 'H Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'Center for Statistical Consulting and Research.'}, {'ForeName': 'Sunitha', 'Initials': 'S', 'LastName': 'Malay', 'Affiliation': 'Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Shauver', 'Affiliation': 'Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of hand surgery,['10.1016/j.jhsa.2019.05.016']
203,32283727,Implicit Theories about Athletic Ability Modulate the Effects of If-Then Planning on Performance in a Standardized Endurance Task.,"Muscular strength has a strong positive impact on cardiometabolic health and fitness. However, building up strength endurance requires effortful exercises. From a health perspective, it is important to understand which psychological strategies help people deal with straining exercise. Self-regulation strategies like if-then planning (also known as implementation intentions) appear particularly promising because they might directly alter how people deal with exercise-induced sensations. However, research on the effects of if-then planning on exercise performance has yielded mixed results so far. One possible reason for these inconsistent results is the lack of tailored interventions and the neglect of potential moderators. To address this, we investigated the efficacy of if-then plans that were tailored to perceived limits of endurance performance (i.e., perceptions of exertion versus pain). In addition, we investigated the effects of these tailored if-then plans while taking into account the potentially moderating effects of individual differences in implicit theories. Specifically, we were interested in the role of implicit theories about athletic performance (i.e., entity versus incremental beliefs) and about the limitation of athletic performance by mental versus physical factors (i.e., mind-over-body beliefs).  N  = 66 male students (age:  M  = 25.8 years,  SD  = 3.2) performed a static muscular endurance task twice (measurement: baseline task vs. main task) and were randomly assigned to a goal or an implementation intention condition. They were instructed to hold two intertwined rings for as long as possible while avoiding contacts between them (measure of performance: time-to-failure and errors). After the baseline task, participants were either given an implementation intention or were simply asked to rehearse the task instructions. The content of the instruction depended on whether they ascribed ultimate baseline task termination to perceptions of exertion or pain. After the main task, implicit theories on athletic ability were assessed. No differences in performance emerged between conditions. In the implementation intention condition, however, stronger entity beliefs were associated with increasing time-to-failure when participants planned to ignore exertion but with decreasing time-to-failure when they planned to ignore pain. This pattern of results was reversed with regard to mind-over-body beliefs. These findings indicate that the efficacy of psychological strategies hinges on recreational athletes' beliefs regarding athletic performance.",2020,No differences in performance emerged between conditions.,"['N  = 66 male students (age:  M  = 25.8 years,  SD  = 3.2) performed a']",['static muscular endurance task twice (measurement: baseline task vs. main task'],['athletic ability'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",66.0,0.0754246,No differences in performance emerged between conditions.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hirsch', 'Affiliation': 'Sport Psychology, Department of Sport Science, University of Konstanz, 78464 Konstanz, Germany.'}, {'ForeName': 'Maik', 'Initials': 'M', 'LastName': 'Bieleke', 'Affiliation': 'Educational Psychology, Department of Psychology, University of Vienna, 1010 Vienna, Austria.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Schüler', 'Affiliation': 'Sport Psychology, Department of Sport Science, University of Konstanz, 78464 Konstanz, Germany.'}, {'ForeName': 'Wanja', 'Initials': 'W', 'LastName': 'Wolff', 'Affiliation': 'Sport Psychology, Department of Sport Science, University of Konstanz, 78464 Konstanz, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17072576']
204,32285978,Effect of e-cigarette advertisement themes on hypothetical e-cigarette purchasing in price-responsive adolescents.,"AIMS


To examine the effect on adolescents of exposure to different e-cigarette advertisement themes on reported likelihood of purchasing e-cigarettes in a hypothetical scenario.
DESIGN


Between-subjects design of four randomly assigned thematic conditions derived from a content analysis of 350 e-cigarette advertisements: general, flavor- and taste-themed, people- and product use-themed or control advertisements for bottled water.
SETTING


Virginia, USA.
PARTICIPANTS


Of 1360 adolescents (13-18 years old) participating, 1063 had complete data (519 current cigarette smokers, 544 tobacco-susceptible non-smokers).
MEASUREMENTS


Participants completed an e-cigarette purchase task, reporting the likelihood of buying an e-cigarette at various prices. Indices of abuse liability included price responsiveness (whether likelihood of purchase decreased with increasing prices) and, among price-responsive adolescents, breakpoint (highest price before definitely would not buy), maximum probability-weighted expenditure (O max  ) and price elasticity (how quickly willingness to purchase decreases as prices increase). Regressions controlled for demographics, prior tobacco ad exposure, tobacco/substance use and sensation-seeking.
FINDINGS


Prior advertisement exposure was positively associated with being price-responsive [odds ratio (OR) = 1.12, 95% confidence interval (CI) = 1.03, 1.22; P < 0.05]. Among price-responsive adolescents (n = 579), breakpoints were 58% higher in the flavor- and taste-themed condition (β = 0.46, 95% CI = <0.01, 0.92) and 75% higher in the people- and product use-themed condition (β = 0.56, 95% CI = 0.10, 1.03) compared with control (Ps < 0.05). Exposure to people- and product use-themed advertisements was associated with a 60% higher O max  (β = 0.47, 95% CI = 0.01, 0.93; P < 0.05). The general and people- and product use-themed conditions were associated with 19% (β = -0.21, 95% CI = -0.38, -0.04) and 21% (β = -0.24, 95% CI = -0.42, -0.06) lower elasticity, respectively (Ps < 0.05).
CONCLUSIONS


E-cigarette advertising exposure may increase reported likelihood of purchasing e-cigarettes, with effects differing by advertisement content. People- and product use-themed e-cigarette advertisements increased reported likelihood of purchasing in price-responsive adolescents.",2020,"FINDINGS


Prior ad exposure was positively associated with being price-responsive (OR 1.12, 95% CI 1.03, 1.22, p<0.05).","['Of 1360 adolescents (13-18 years old) participating, 1063 had complete data (519 current cigarette smokers, 544 tobacco-susceptible nonsmokers', 'Between-subjects design of four randomly-assigned thematic conditions derived from a content analysis of 350 e-cigarette ads: general', 'Virginia, USA', 'hypothetical e-cigarette purchasing in price-responsive adolescents', 'adolescents of exposure to different e-cigarette advertisement themes on reported likelihood of purchasing e-cigarettes in a hypothetical scenario']","['e-cigarette advertisement themes', 'flavor- and taste-themed, people- and product use-themed, or control ads for bottled water']","['e-cigarette purchase task, reporting the likelihood of buying an e-cigarette at various prices']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1572482', 'cui_str': 'Bottled Water'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0080045', 'cui_str': 'Prices'}]",4.0,0.0673399,"FINDINGS


Prior ad exposure was positively associated with being price-responsive (OR 1.12, 95% CI 1.03, 1.22, p<0.05).","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Barnes', 'Affiliation': 'Department of Health Behavior and Policy, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Rose S', 'Initials': 'RS', 'LastName': 'Bono', 'Affiliation': 'Department of Health Behavior and Policy, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Alyssa K', 'Initials': 'AK', 'LastName': 'Rudy', 'Affiliation': 'Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Cosima', 'Initials': 'C', 'LastName': 'Hoetger', 'Affiliation': 'Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Nicksic', 'Affiliation': 'Department of Health Behavior and Policy, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Caroline O', 'Initials': 'CO', 'LastName': 'Cobb', 'Affiliation': 'Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15084']
205,32060566,Effect of Low-Dose Vitamin K2 Supplementation on Bone Mineral Density in Middle-Aged and Elderly Chinese: A Randomized Controlled Study.,"Previous studies indicated a positive effect of vitamin K2 (VK2) supplementation on bone turnover biomarkers and bone mineral density (BMD), but the doses varied, and few studies have focused on the difference between VK2 supplementation alone and in combination with calcium and vitamin D 3 . The aim of this study was to explore a low and effective dose of VK2 for improving BMD, and to examine whether the co-supplementation of VK2, calcium and vitamin D 3  would bring greater effects. In this trial, a total of 311 community-dwelling men and postmenopausal women aged 50 and 75 years were randomly assigned to four groups, receiving placebo, 50 µg/day, 90 µg/day or co-supplementation with calcium (500 mg/day) and vitamin D 3  (10 µg/day) for 1 year. At the endpoint, the bone loss of femoral neck was significantly lower in postmenopausal women in the two 90 µg groups (treatment × time, p = 0.006) compared with placebo, but no effects in men. Serum biomarkers cOC/ucOC ratio increased in the intervention groups (treatment × time, p < 0.001). VK2 supplementation in dose of 90 µg/day performed a significant effect on reducing bone loss in postmenopausal women, but in combination with calcium and vitamin D 3  brought no additional effects.Trial registration This trial was registered at http://www.chictr.org.cn as chiCTR1800019240.",2020,"Serum biomarkers cOC/ucOC ratio increased in the intervention groups (treatment × time, p < 0.001).","['postmenopausal women', 'Middle-Aged and Elderly Chinese', '311 community-dwelling men and postmenopausal women aged 50 and 75\xa0years']","['VK2, calcium and vitamin D', 'placebo', 'placebo, 50\xa0µg/day, 90\xa0µg/day or co-supplementation with calcium', 'vitamin K2 (VK2) supplementation', 'VK2', 'Low-Dose Vitamin K2 Supplementation', 'VK2 supplementation']","['bone loss of femoral neck', 'Bone Mineral Density', 'bone turnover biomarkers and bone mineral density (BMD', 'bone loss', 'Serum biomarkers cOC/ucOC ratio']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",311.0,0.207739,"Serum biomarkers cOC/ucOC ratio increased in the intervention groups (treatment × time, p < 0.001).","[{'ForeName': 'Yingfeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Nutrition and Food Hygiene, Public Health College, Harbin Medical University, 157 Baojian Road, Nangang District, Harbin, 150086, People's Republic of China.""}, {'ForeName': 'Zhipeng', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Nutrition and Food Hygiene, Public Health College, Harbin Medical University, 157 Baojian Road, Nangang District, Harbin, 150086, People's Republic of China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Duan', 'Affiliation': ""Vitamin K2 Research Center, Shenyang Pharmaceutical University, 103 Wenhua Road, Shenhe District, Shenyang, 110015, People's Republic of China.""}, {'ForeName': 'Yeyu', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': ""Vitamin K2 Research Center, Shenyang Pharmaceutical University, 103 Wenhua Road, Shenhe District, Shenyang, 110015, People's Republic of China.""}, {'ForeName': 'Sen', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Nutrition and Food Hygiene, Public Health College, Harbin Medical University, 157 Baojian Road, Nangang District, Harbin, 150086, People's Republic of China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Nutrition and Food Hygiene, Public Health College, Harbin Medical University, 157 Baojian Road, Nangang District, Harbin, 150086, People's Republic of China.""}, {'ForeName': 'Hongyin', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Nutrition and Food Hygiene, Public Health College, Harbin Medical University, 157 Baojian Road, Nangang District, Harbin, 150086, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Nutrition and Food Hygiene, Public Health College, Harbin Medical University, 157 Baojian Road, Nangang District, Harbin, 150086, People's Republic of China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""Department of Nutrition and Food Hygiene, Public Health College, Harbin Medical University, 157 Baojian Road, Nangang District, Harbin, 150086, People's Republic of China.""}, {'ForeName': 'Jiepeng', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Vitamin K2 Research Center, Shenyang Pharmaceutical University, 103 Wenhua Road, Shenhe District, Shenyang, 110015, People's Republic of China. stcjp888@163.com.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Nutrition and Food Hygiene, Public Health College, Harbin Medical University, 157 Baojian Road, Nangang District, Harbin, 150086, People's Republic of China. liying_helen@163.com.""}]",Calcified tissue international,['10.1007/s00223-020-00669-4']
206,31295174,Risk Factors for Adverse Birth Outcomes in the PROMISE 1077BF/1077FF Trial.,"BACKGROUND


In the multicountry PROMISE 1077BF/1077FF trial, the risk of low birth weight (LBW; <2500 g) and preterm delivery (PTD; <37 weeks) was significantly higher among women initiating a protease inhibitor-based antiretroviral treatment (ART) regimen than those receiving ZDV alone. Among those assigned to a protease inhibitor regimen, tenofovir/emtricitabine was associated with the more severe outcomes of very LBW (<1500 g) and very PTD (<34 weeks) compared with zidovudine/lamivudine.
METHODS


We used multivariate logistic regression to further explore these treatment findings, taking into account demographic baseline clinical and postentry obstetrical factors. We evaluated individual adverse outcomes and composites that included stillbirth and early loss/spontaneous abortion.
RESULTS


Among 3333 women delivering at least 1 live infant, median maternal age at enrollment was 26 years; 661 (20%) were primiparous, and 110 (3.3%) reported at least 1 previous PTD. Seventeen percent of newborns were LBW, 1% were very LBW, 17% had PTD, and 3% had very PTD. Treatment allocation remained strongly associated with multiple adverse outcomes after controlling for other risk factors with both ART regimens exhibiting increased risk relative to ZDV alone. Other risk factors remaining significant in at least one of the multivariate models included the following: country, gestational age at entry, maternal age, maternal body mass index, previous PTD, history of alcohol use, baseline HIV viral titer, multiple gestation, and several obstetric risk factors.
CONCLUSIONS


ART effects on adverse pregnancy outcomes reported in the randomized PROMISE trial remained strongly significant even after controlling for demographic, baseline clinical, and obstetrical risk factors, which were also associated with these outcomes.",2019,Treatment allocation remained strongly associated with multiple adverse outcomes after controlling for other risk factors with both ART regimens exhibiting increased risk relative to ZDV alone.,"['3333 women delivering at least 1 live infant, median maternal age at enrollment was 26 years; 661 (20%) were primiparous, and 110 (3.3%) reported at least 1 previous PTD']","['tenofovir/emtricitabine', 'zidovudine/lamivudine']","['adverse pregnancy outcomes', 'stillbirth and early loss/spontaneous abortion', 'severe outcomes of very LBW']","[{'cui': 'C4708907', 'cui_str': '3333 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0024915', 'cui_str': 'Maternal Age'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}]","[{'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",3333.0,0.195455,Treatment allocation remained strongly associated with multiple adverse outcomes after controlling for other risk factors with both ART regimens exhibiting increased risk relative to ZDV alone.,"[{'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Sebikari', 'Affiliation': 'Clinical Department, Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Farhad', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Fenton', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA.'}, {'ForeName': 'Maxensia', 'Initials': 'M', 'LastName': 'Owor', 'Affiliation': 'Clinical Department, Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Jeffrey S A', 'Initials': 'JSA', 'LastName': 'Stringer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Qin', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA.'}, {'ForeName': 'Nahida', 'Initials': 'N', 'LastName': 'Chakhtoura', 'Affiliation': 'National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Maternal and Paediatric Infectious Diseases Branch, Bethesda, MD.'}, {'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Chi', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Friday', 'Initials': 'F', 'LastName': 'Saidi', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of North Carolina (UNC) Project Lilongwe, Lilongwe, Malawi.'}, {'ForeName': 'Neetal', 'Initials': 'N', 'LastName': 'Nevrekar', 'Affiliation': 'Clinical Research Department, Byramiee Jeeieebhoy Government Medical College, Pune, India.'}, {'ForeName': 'Avy', 'Initials': 'A', 'LastName': 'Violari', 'Affiliation': 'Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Tsungai', 'Initials': 'T', 'LastName': 'Chipato', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'McIntyre', 'Affiliation': 'Anova Health Institute, Johannesburg, South Africa.'}, {'ForeName': 'Dhayendre', 'Initials': 'D', 'LastName': 'Moodley', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Clinical Medicine, Centre for AIDS Research in South Africa, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Taha E', 'Initials': 'TE', 'LastName': 'Taha', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Theron', 'Affiliation': 'Department of Obstetrics and Gynecology, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002072']
207,31467447,"Parents of newborns in the NICU enrolled in genome sequencing research: hopeful, but not naïve.","PURPOSE


In 2014, our institution launched a randomized controlled trial (RCT) comparing rapid genome sequencing (GS) to standard clinical evaluations of infants with suspected genetic disorders. This study aimed to understand parental response to the use of GS for their newborn babies.
METHODS


Twenty-three of 128 parents whose infant had enrolled in the RCT completed a retrospective survey and interview addressing attitudes about GS and responses to receiving diagnostic information. We also collected information about participants' genetic literacy, genetic knowledge, numeracy, and symptoms of anxiety and depression.
RESULTS


The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial. The 12 participants who had received a unifying diagnosis for their child's symptoms described personal utility of the information. Some reported the diagnosis led to changes in medical care. Participants showed understanding of some of the psychological risks of GS. For example, 21 (91.3%) agreed or strongly agreed that genetic testing could reveal disturbing results.
CONCLUSIONS


Parents who enrolled their newborn in a RCT of GS demonstrated awareness of a psychological risk, but generally held positive beliefs about GS and perceived the benefits outweighed the risk.",2020,The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial.,"['infants with suspected genetic disorders', 'Twenty-three of 128 parents whose infant had enrolled in the RCT completed a retrospective survey and interview addressing attitudes about GS and responses to receiving diagnostic information', 'Parents of newborns in the NICU enrolled in genome sequencing research', ""12 participants who had received a unifying diagnosis for their child's symptoms described personal utility of the information""]",[],['psychological risks of GS'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0019247', 'cui_str': 'Hereditary Diseases'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0035168'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",128.0,0.0537586,The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial.,"[{'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Berrios', 'Affiliation': ""Center for Pediatric Genomic Medicine, Children's Mercy Kansas City, Kansas City, MO, USA. cdberrios@cmh.edu.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Koertje', 'Affiliation': ""Division of Developmental and Behavioral Sciences, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Noel-MacDonnell', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Soden', 'Affiliation': ""Center for Pediatric Genomic Medicine, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lantos', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-019-0644-5']
208,32280080,Effects of nimodipine combined with betahistine on CRP and other inflammatory cytokines and vascular endothelial function in patients with hypertensive cerebral vasospasm.,"OBJECTIVE


This study aims to investigate the effect of nimodipine combined with betahistine on the levels of CRP and other inflammatory cytokines, as well as vascular endothelial function in patients with hypertensive cerebral vasospasm.
METHODS


A total of 80 patients with hypertensive cerebral vasospasm from March 2016 to September 2018 were enrolled and randomly equally divided into two groups. At 1 week before enrollment, the application of all antihypertensive drugs was stopped. Then amlodipine tablets were used in control group, based on which nimodipine tablets were applied in observation group. All the patients included were followed up for 1 month. The changes in the cerebral vasospasm index in the course of treatment as well as inflammatory cytokines and indicators related to vascular endothelial function at 1 month after treatment were measured and compared between the two groups. The correlations of the cerebral vasospasm index with the changes in inflammatory cytokines and vascular endothelial function-related factors in the body were analyzed. Finally, the effective rates of blood pressure regulation and cerebral vasospasm treatment were compared, while the adverse reactions and the overall clinical treatment effect of the two groups were evaluated.
RESULTS


The cerebral vasospasm indexes in observation group were significantly lower than those in control group at 3 d, 1 week and 1 month after treatment (p < 0.05). At 1 month after treatment, the levels of inflammatory cytokines such as high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α) in observation group were significantly reduced compared to those in control group (p < 0.05). As for vascular endothelial function-related indicators, the endothelin-1 (ET-1) level in observation group was markedly lower than that in control group, whereas the level of nitric oxide (NO) was statistically higher than that in control group (p < 0.05). The cerebral vasospasm index was statistically positively correlated with changes in hs-CRP, IL-6, TNF-α and ET-1 (p < 0.05), but negatively correlated with changes in NO (p < 0.05). Besides, the effective rates of blood pressure regulation and cerebral vasospasm treatment in observation group were significantly higher than those in control group (p < 0.05). The overall treatment effective rate in observation group was markedly higher than that in control group (p < 0.05), and there were no significant differences of adverse reactions between the two groups (p > 0.05).
CONCLUSION


For the treatment of hypertensive cerebral vasospasm, combined application of betahistine on the basis of nimodipine can effectively reduce the body's aseptic inflammatory responses, improve vascular endothelial function and increase the cerebral circulation blood flow, which offers a favorable strategy for clinical therapy.",2020,"The overall treatment effective rate in observation group was markedly higher than that in control group (p < 0.05), and there were no significant differences of adverse reactions between the two groups (p > 0.05).
","['80 patients with hypertensive cerebral vasospasm from March 2016 to September 2018', 'patients with hypertensive cerebral vasospasm']","['nimodipine', 'nimodipine combined with betahistine', 'betahistine', 'nimodipine tablets', 'amlodipine']","['effective rates of blood pressure regulation and cerebral vasospasm treatment', 'overall treatment effective rate', 'levels of inflammatory cytokines such as high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α', 'vascular endothelial function', 'cerebral vasospasm indexes', 'cerebral circulation blood flow', 'cerebral vasospasm index', 'CRP and other inflammatory cytokines and vascular endothelial function', 'adverse reactions', 'hs-CRP, IL-6, TNF-α and ET-1', 'vascular endothelial function-related indicators, the endothelin-1 (ET-1) level', 'level of nitric oxide (NO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0265110', 'cui_str': 'Spasm of cerebral arteries'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0028094', 'cui_str': 'Nimodipine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0005301', 'cui_str': 'BETAHISTINE'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0265110', 'cui_str': 'Spasm of cerebral arteries'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}]",80.0,0.0301013,"The overall treatment effective rate in observation group was markedly higher than that in control group (p < 0.05), and there were no significant differences of adverse reactions between the two groups (p > 0.05).
","[{'ForeName': 'Xuanwei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Rehabilitation, ShenZhen DaPeng New District NanAo People's Hospital, Shenzhen, Guangdong, China.""}, {'ForeName': ""Na'na"", 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Department of Acupuncture and Massage, Shenzhen Luohu District Hospital of Chinese Medicine, Shenzhen, Guangdong, China.'}, {'ForeName': 'Kexue', 'Initials': 'K', 'LastName': 'Zeng', 'Affiliation': 'Department of Acupuncture and Massage, GuangDong Province Second Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Xiao', 'Affiliation': ""Department of Rehabilitation, ShenZhen DaPeng New District NanAo People's Hospital, Shenzhen, Guangdong, China.""}, {'ForeName': 'Pengjie', 'Initials': 'P', 'LastName': 'Sheng', 'Affiliation': 'Department of Acupuncture and Massage, Shenzhen Luohu District Hospital of Chinese Medicine, Shenzhen, Guangdong, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Rehabilitation, Shenzhen Sanming Group, Kerry Rehabilitation Medicine Research, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yulong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, The First Affiliated Hospital, Shenzhen University, Shenzhen, Guangdong, China.'}]",Clinical hemorheology and microcirculation,['10.3233/CH-190589']
209,32280083,Erythrocyte deformability and aggregation in morbidly obese women undergoing laparoscopic gastric bypass surgery and effects of oral omega-3 fatty acid supplementation.,"BACKGROUND


An adequate erythrocyte function is vital for tissue oxygenation and wound healing. The erythrocyte membrane phospholipid composition plays an important role in erythrocyte function and administration of omega-3 fatty acids may provide a means to improve it.
OBJECTIVE


To investigate peri-operative erythrocyte function and effects of oral omega-3 fatty acids in morbidly obese women undergoing gastric bypass surgeryMETHODS:Fifty-six morbidly obese women undergoing laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery were randomized between a low calorie diet (LCD) during 2 weeks or oral omega-3 poly-unsaturated fatty acids (n-3 PUFAs) and a normal diet during 4 weeks. Peri-operative blood samples were analyzed with the Lorrca MaxSIS Ektacytometer for erythrocyte deformability and aggregability.
RESULTS


There were no significant differences in erythrocyte function between the groups at any time point. Only erythrocyte aggregability parameters were affected by surgery. At six month follow-up, aggregation index (AI) and cholesterol, glucose and insulin were significantly improved.
CONCLUSIONS


In this study, oral Omega-3 supplementation did not affect erythrocyte function compared to a LCD. Six months after surgery a significant improvement in AI and metabolic parameters was observed in both groups, contributing to a reduction in the risk at thromboembolic and cardiovascular complications.",2020,There were no significant differences in erythrocyte function between the groups at any time point.,"['morbidly obese women undergoing gastric bypass surgeryMETHODS:Fifty-six morbidly obese women undergoing laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery', 'morbidly obese women undergoing']","['oral omega-3 fatty acids', 'oral Omega-3 supplementation', 'oral omega-3 poly-unsaturated fatty acids (n-3 PUFAs', 'laparoscopic gastric bypass surgery', 'low calorie diet (LCD', 'oral omega-3 fatty acid supplementation']","['erythrocyte aggregability parameters', 'erythrocyte function', 'Erythrocyte deformability and aggregation', 'AI and metabolic parameters', 'risk at thromboembolic and cardiovascular complications', 'aggregation index (AI) and cholesterol, glucose and insulin']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C4039248', 'cui_str': 'Laparoscopic bypass of stomach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0014774', 'cui_str': 'Erythrocyte deformability'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0161816', 'cui_str': 'Cardiac complication'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",,0.0237369,There were no significant differences in erythrocyte function between the groups at any time point.,"[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Bakker', 'Affiliation': 'Northwest Clinics Alkmaar, Alkmaar, The Netherlands.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Schoorl', 'Affiliation': 'Northwest Clinics Alkmaar, Alkmaar, The Netherlands.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Demirkiran', 'Affiliation': 'Red Cross Hospital Beverwijk, Beverwijk, The Netherlands.'}, {'ForeName': 'Huib A', 'Initials': 'HA', 'LastName': 'Cense', 'Affiliation': 'Red Cross Hospital Beverwijk, Beverwijk, The Netherlands.'}, {'ForeName': 'Alexander P J', 'Initials': 'APJ', 'LastName': 'Houdijk', 'Affiliation': 'Northwest Clinics Alkmaar, Alkmaar, The Netherlands.'}]",Clinical hemorheology and microcirculation,['10.3233/CH-190777']
210,32247517,A Bidirectional Analysis of Feeding Practices and Eating Behaviors in Parent/Child Dyads from Low-Income and Minority Households.,"OBJECTIVE


To prospectively examine the bidirectional relationship between parental feeding practices (eg, instrumental feeding, encouragement to eat) and child eating behaviors (eg, food responsiveness, emotional eating) in low-income, ethnically diverse preschool children over a 3-year period.
STUDY DESIGN


Parent/child (age 2-4 years at baseline) pairs (n = 222 non-Hispanics; n = 312 Hispanics) participated in NET-Works (Now Everybody Together for Amazing and Healthful Kids), a randomized controlled trial carried out in community and in-home settings in urban areas of Minnesota. Data were collected at baseline and 12, 24, and 36 months. The present study is a secondary data analysis using cross-lagged models to identify bidirectional associations between parental feeding practices and child eating behaviors.
RESULTS


Three models showed significant cross-lagged effects (P < .05): model 1, parental instrumental feeding influencing later child food responsiveness; model 2, parental emotional feeding influencing later child food responsiveness; and model 3, parental emotional feeding influencing later child eating satiety. Model 1 showed significant bidirectional temporal paths, whereas models 2 and 3 showed significant unidirectional temporal paths from parental feeding practices to child eating behaviors.
CONCLUSIONS


Parental instrumental and emotional feeding practices prospectively influence child food responsiveness and satiety. This study demonstrates causal temporality between parental feeding practices and child eating behaviors. Heath care providers may want to use findings regarding parent feeding practices as part of their anticipatory guidance during well-child visits with parents of preschoolers.",2020,"RESULTS


Three models showed significant cross-lagged effects (P < .05): model 1, parental instrumental feeding influencing later child food responsiveness; model 2, parental emotional feeding influencing later child food responsiveness; and model 3, parental emotional feeding influencing later child eating satiety.","['Parent/child (age 2-4\xa0years at baseline) pairs (n\xa0=\xa0222 non-Hispanics; n\xa0=\xa0312 Hispanics) participated in', 'low-income, ethnically diverse preschool children over a 3-year period', 'Parent/Child Dyads from Low-Income and Minority Households', 'parental feeding practices and child eating behaviors', 'community and in-home settings in urban areas of Minnesota']",['NET-Works '],"['parental emotional feeding influencing later child food responsiveness; and model 3, parental emotional feeding influencing later child eating satiety', 'child eating behaviors (eg, food responsiveness, emotional eating']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}]","[{'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0322418,"RESULTS


Three models showed significant cross-lagged effects (P < .05): model 1, parental instrumental feeding influencing later child food responsiveness; model 2, parental emotional feeding influencing later child food responsiveness; and model 3, parental emotional feeding influencing later child eating satiety.","[{'ForeName': 'Jerica M', 'Initials': 'JM', 'LastName': 'Berge', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, MN. Electronic address: jberge@umn.edu.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, MN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Veblen-Mortenson', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Kunin-Batson', 'Affiliation': 'Department of Pediatrics, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Sherwood', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Simone A', 'Initials': 'SA', 'LastName': 'French', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.02.001']
211,32282492,The Effect of an Empowerment Program on the Perceived Risk and Physical Health of Patients With Coronary Artery Disease.,"This study was conducted to assess the effect of an empowerment program on the perceived risk and physical health of patients with coronary artery disease. This randomized clinical trial recruited 84 patients with coronary artery disease admitted to post-cardiac care unit (CCU) wards in Tehran Heart Center in 2017. The study subjects were selected and assessed according to inclusion criteria and assigned to intervention and control groups by block randomization. Both groups completed questionnaires for demographic details and disease history, perceived risk in cardiac patients, and physical health. The Magic Empowerment Program was performed for the intervention group as 3 workshops on 3 successive days. Intervention continued after patients' discharge from the hospital through phone calls once a week for 8 weeks. The perceived risk in cardiac patients and physical health questionnaires were completed for both groups. Postintervention results showed significant differences between the 2 groups in total score of perceived risk (P = .001) and its subscales. The Empowerment Program changed patients' attitudes toward risk-motivating behavior change and improving physical health.",2020,Postintervention results showed significant differences between the 2 groups in total score of perceived risk (P = .001) and its subscales.,"['84 patients with coronary artery disease admitted to post-cardiac care unit (CCU) wards in Tehran Heart Center in 2017', 'Patients With Coronary Artery Disease', 'patients with coronary artery disease']","['Empowerment Program', 'empowerment program']","['risk-motivating behavior change and improving physical health', 'physical health questionnaires', 'total score of perceived risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0150158', 'cui_str': 'Cardiac care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",84.0,0.0187258,Postintervention results showed significant differences between the 2 groups in total score of perceived risk (P = .001) and its subscales.,"[{'ForeName': 'Zeinab Ghasemzadeh', 'Initials': 'ZG', 'LastName': 'Kuchi', 'Affiliation': 'School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran (Ms Kuchi); Medical Surgical Department, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran (Ms Zakerimoghadam); School of Nursing and Midwifery, Nursing and Midwifery Care Research Center, Tehran University of Medical Sciences, Tehran, Iran (Ms Esmaeili); and Tehran University of Medical Sciences, Tehran, Iran (Mr Geraiely).'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Zakerimoghadam', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Esmaeili', 'Affiliation': ''}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Geraiely', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000370']
212,32268592,Effects of Regular Taekwondo Intervention on Oxidative Stress Biomarkers and Myokines in Overweight and Obese Adolescents.,"Purpose : Regular exercise can alleviate oxidative stress related to obesity and can induce secretion of myokines that are involved in the regulation of metabolic homeostasis. There are no studies examining changes in these variables as a result of Taekwondo training intervention. We aimed to investigate the effect of Taekwondo training on oxidative stress and myokine levels in overweight and obese adolescents.  Methods:  We randomly assigned 20 overweight and obese adolescents to control (control group; CG, n = 10) and experimental (experimental group; EG, n = 10) groups. The EG performed Taekwondo training five times a week for 16 weeks. Physical parameters (height, weight, body mass index (BMI)), physical fitness (maximal oxygen uptake (VO 2 max) (cardiorespiratory endurance), grip and leg strength (muscular strength), sit-and-reach (flexibility), Sargent jump (power), and stork stand test (balance)) were measured before and after intervention. We measured levels of serum oxidative stress markers (plasma malondialdehyde (MDA) and superoxide dismutase (SOD)) and myokines (serum interleukin-15 (IL-15), brain-derived neurotrophic factor (BDNF), irisin, and myostatin).  Results:  The weight and BMI in the EG after intervention were significantly lower and leg strength (muscular strength), sit-and-reach (flexibility), and Sargent jump (power) were significantly improved compared to those of the CG ( p <  0.05). There were no significant interaction effects in terms of height, VO 2  max, grip strength, or stork stand test ( p >  0.05). The SOD and BDNF level after intervention were significantly higher in the EG after the intervention, whereas MDA and irisin levels were significantly lower than those of the CG ( p <  0.05). There were no significant interaction effects in terms of serum IL-15 and myostatin levels ( p >  0.05).  Conclusions:  Taekwondo training can reduce obesity and increase physical fitness with respect to muscular strength, flexibility, and power as well as alleviate oxidative stress and modulate myokine secretion in adolescents.",2020,"There were no significant interaction effects in terms of height, VO 2  max, grip strength, or stork stand test ( p >  0.05).","['Overweight and Obese Adolescents', '20 overweight and obese adolescents to', 'overweight and obese adolescents', 'adolescents']","['Taekwondo training', 'control (control group; CG', 'Regular Taekwondo Intervention']","['oxidative stress and myokine levels', 'serum oxidative stress markers (plasma malondialdehyde (MDA) and superoxide dismutase (SOD)) and myokines (serum interleukin-15 (IL-15), brain-derived neurotrophic factor (BDNF), irisin, and myostatin', 'height, VO 2  max, grip strength, or stork stand test', 'MDA and irisin levels', 'Oxidative Stress Biomarkers and Myokines', 'SOD and BDNF level', 'Physical parameters (height, weight, body mass index (BMI)), physical fitness (maximal oxygen uptake (VO 2 max) (cardiorespiratory endurance), grip and leg strength (muscular strength), sit-and-reach (flexibility), Sargent jump (power), and stork stand test (balance', 'leg strength (muscular strength), sit-and-reach (flexibility), and Sargent jump (power', 'weight and BMI', 'serum IL-15 and myostatin levels']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0254610', 'cui_str': 'Interleukin 15'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0325459', 'cui_str': 'Stork'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",20.0,0.010736,"There were no significant interaction effects in terms of height, VO 2  max, grip strength, or stork stand test ( p >  0.05).","[{'ForeName': 'Hee-Tae', 'Initials': 'HT', 'LastName': 'Roh', 'Affiliation': 'Department of Physical Education, College of Arts and Physical Education, Dong-A University, Busan 49315, Korea.'}, {'ForeName': 'Su-Youn', 'Initials': 'SY', 'LastName': 'Cho', 'Affiliation': 'Department of Taekwondo, Youngsan University, Yangsan-si 50510, Korea.'}, {'ForeName': 'Wi-Young', 'Initials': 'WY', 'LastName': 'So', 'Affiliation': 'Sports and Health Care Major, College of Humanities and Arts, Korea National University of Transportation, Chungju-si 27469, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17072505']
213,30476251,Atorvastatin Treatment of Cavernous Angiomas with Symptomatic Hemorrhage Exploratory Proof of Concept (AT CASH EPOC) Trial.,"BACKGROUND


More than a million Americans harbor a cerebral cavernous angioma (CA), and those who suffer a prior symptomatic hemorrhage have an exceptionally high rebleeding risk. Preclinical studies show that atorvastatin blunts CA lesion development and hemorrhage through inhibiting RhoA kinase (ROCK), suggesting it may confer a therapeutic benefit.
OBJECTIVE


To evaluate whether atorvastatin produces a difference compared to placebo in lesional iron deposition as assessed by quantitative susceptibility mapping (QSM) on magnetic resonance imaging in CAs that have demonstrated a symptomatic hemorrhage in the prior year. Secondary aims shall assess effects on vascular permeability, ROCK activity in peripheral leukocytes, signal effects on clinical outcomes, adverse events, and prespecified subgroups.
METHODS


The phase I/IIa placebo-controlled, double-blinded, single-site clinical trial aims to enroll 80 subjects randomized 1-1 to atorvastatin (starting dose 80 mg PO daily) or placebo. Dosing shall continue for 24-mo or until reaching a safety endpoint.
EXPECTED OUTCOMES


The trial is powered to detect an absolute difference of 20% in the mean percent change in lesional QSM per year (2-tailed, power 0.9, alpha 0.05). A decrease in QSM change would be a signal of potential benefit, and an increase would signal a safety concern with the drug.
DISCUSSION


With firm mechanistic rationale, rigorous preclinical discoveries, and biomarker validations, the trial shall explore a proof of concept effect of a widely used repurposed drug in stabilizing CAs after a symptomatic hemorrhage. This will be the first clinical trial of a drug aimed at altering rebleeding in CA.",2019,"Preclinical studies show that atorvastatin blunts CA lesion development and hemorrhage through inhibiting RhoA kinase (ROCK), suggesting it may confer a therapeutic benefit.
",[],"['atorvastatin', 'Atorvastatin', 'placebo']","['vascular permeability, ROCK activity', 'QSM change']",[],"[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0162337', 'cui_str': 'Vascular Permeability'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",80.0,0.551617,"Preclinical studies show that atorvastatin blunts CA lesion development and hemorrhage through inhibiting RhoA kinase (ROCK), suggesting it may confer a therapeutic benefit.
","[{'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Polster', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Stadnik', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Akers', 'Affiliation': 'Angioma Alliance, Norfolk, Virginia.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Christoforidis', 'Affiliation': 'Department of Diagnostic Radiology, The University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Maged D', 'Initials': 'MD', 'LastName': 'Fam', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Kelly D', 'Initials': 'KD', 'LastName': 'Flemming', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Romuald', 'Initials': 'R', 'LastName': 'Girard', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hobson', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'James I', 'Initials': 'JI', 'LastName': 'Koenig', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, Bethesda, Maryland.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Koskimäki', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lane', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Liao', 'Affiliation': 'Section of Cardiology, Department of Medicine, The University of Chicago Medical Center, Illinois.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Angioma Alliance, Norfolk, Virginia.'}, {'ForeName': 'Seán B', 'Initials': 'SB', 'LastName': 'Lyne', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Nichol', 'Initials': 'N', 'LastName': 'McBee', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, Bethesda, Maryland.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Morrison', 'Affiliation': 'Department of Neurology, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Piedad', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Shenkar', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sorrentino', 'Affiliation': 'Section of Cardiology, Department of Medicine, The University of Chicago Medical Center, Illinois.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Thompson', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Whitehead', 'Affiliation': 'Department of Cardiovascular Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Hussein A', 'Initials': 'HA', 'LastName': 'Zeineddine', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Issam A', 'Initials': 'IA', 'LastName': 'Awad', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}]",Neurosurgery,['10.1093/neuros/nyy539']
214,31852769,"Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study.","OBJECTIVE


Faecal microbiota transplantation (FMT) from healthy donors to patients with irritable bowel syndrome (IBS) has been attempted in two previous double-blind, placebo-controlled studies. While one of those studies found improvement of the IBS symptoms, the other found no effect. The present study was conducted to clarify these contradictory findings.
DESIGN


This randomised, double-blind, placebo-controlled study randomised 165 patients with IBS to placebo (own faeces), 30 g FMT or 60 g FMT at a ratio of 1:1:1. The material for FMT was obtained from one healthy, well-characterised donor, frozen and administered via gastroscope. The primary outcome was a reduction in the IBS symptoms at 3 months after FMT (response). A response was defined as a decrease of 50 or more points in the total IBS symptom score. The secondary outcome was a reduction in the dysbiosis index (DI) and a change in the intestinal bacterial profile, analysed by 16S rRNA gene sequencing, at 1 month following FMT.
RESULTS


Responses occurred in 23.6%, 76.9% (p<0.0001) and 89.1% (p<00.0001) of the patients who received placebo, 30 g FMT and 60 g FMT, respectively. These were accompanied by significant improvements in fatigue and the quality of life in patients who received FMT. The intestinal bacterial profiles changed also significantly in the groups received FMT. The FMT adverse events were mild self-limiting gastrointestinal symptoms.
CONCLUSIONS


FMT is an effective treatment for patients with IBS. Utilising a well-defined donor with a normal DI and favourable specific microbial signature is essential for successful FMT. The response to FMT increases with the dose.  Trial registration  www.clinicaltrials.gov (NCT03822299) and www.cristin.no (ID657402).",2020,"RESULTS


Responses occurred in 23.6%, 76.9% (p<0.0001) and 89.1% (p<00.0001) of the patients who received placebo, 30 g FMT and 60 g FMT, respectively.","['patients with IBS', 'patients with irritable bowel syndrome', '165 patients with IBS to placebo (own faeces), 30\u2009g FMT or 60\u2009g FMT at a ratio of 1:1:1', 'healthy donors to patients with irritable bowel syndrome (IBS']","['faecal microbiota transplantation', 'FMT', 'placebo', 'Faecal microbiota transplantation (FMT', 'www.cristin.no']","['IBS symptoms', 'reduction in the dysbiosis index (DI) and a change in the intestinal bacterial profile, analysed by 16S rRNA gene sequencing', 'intestinal bacterial profiles', 'fatigue and the quality of life', 'total IBS symptom score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal Transplantation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3658208', 'cui_str': 'Disbiosis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0035899', 'cui_str': 'Ribosomal RNA Genes'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",165.0,0.430062,"RESULTS


Responses occurred in 23.6%, 76.9% (p<0.0001) and 89.1% (p<00.0001) of the patients who received placebo, 30 g FMT and 60 g FMT, respectively.","[{'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'El-Salhy', 'Affiliation': 'Stord Hospital, Stord, Norway magdy.elsalhy@sklbb.no.'}, {'ForeName': 'Jan Gunnar', 'Initials': 'JG', 'LastName': 'Hatlebakk', 'Affiliation': 'Department of Clinical Medicine, University of Bergen Faculty of Medicine and Dentistry, Bergen, Norway.'}, {'ForeName': 'Odd Helge', 'Initials': 'OH', 'LastName': 'Gilja', 'Affiliation': 'Department of Clinical Medicine, University of Bergen Faculty of Medicine and Dentistry, Bergen, Norway.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Bråthen Kristoffersen', 'Affiliation': 'Genetic Analysis As, Oslo, Norway.'}, {'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Hausken', 'Affiliation': 'Department of Clinical Medicine, University of Bergen Faculty of Medicine and Dentistry, Bergen, Norway.'}]",Gut,['10.1136/gutjnl-2019-319630']
215,32132141,Safety of Liraglutide in Type 2 Diabetes and Chronic Kidney Disease.,"BACKGROUND AND OBJECTIVES


The glucagon-like peptide-1 receptor agonist liraglutide demonstrated cardiovascular and kidney benefits in the LEADER trial, particularly in participants with CKD.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


This  post hoc  analysis evaluated the safety of liraglutide treatment in patients with CKD in LEADER. Overall, 9340 patients were randomized to liraglutide or placebo, both in addition to standard of care. Of those, 2158 patients had CKD versus 7182 without CKD (defined as eGFR <60 versus ≥60 ml/min per 1.73 m 2 , respectively); 966 patients had macroalbuminuria and 2456 had microalbuminuria (urine albumin-creatinine ratio >300 mg/g and ≥30 to ≤300 mg/g, respectively). At baseline, the mean eGFR in patients with CKD was 46±11 ml/min per 1.73 m 2  versus 91±22 ml/min per 1.73 m 2  in those without CKD. Time to first event within event groups was analyzed using Cox regression with treatment group, baseline eGFR group, or baseline albuminuria group as fixed factors.
RESULTS


Overall, serious adverse events were more frequently recorded in patients with CKD compared with those without CKD (59% versus 50%; interaction  P =0.11); however, they occurred to the same extent in those on liraglutide versus placebo. Similarly, no interaction of adverse events with randomized therapy was observed in patients with micro- or macro- versus normoalbuminuria (interaction  P =0.11). Risk of severe hypoglycemia was significantly reduced with liraglutide versus placebo in patients with CKD or with micro- or macroalbuminuria (hazard ratio, 0.63 [95% CI, 0.43 to 0.91] and 0.57 [95% CI, 0.40 to 0.82], respectively).
CONCLUSIONS


In LEADER, the use of liraglutide in those with CKD was safe, with no difference between patients with and without CKD.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


ClinicalTrials.gov; NCT01179048 (https://clinicaltrials.gov/ct2/show/NCT01179048).",2020,"Risk of severe hypoglycemia was significantly reduced with liraglutide versus placebo in patients with CKD or with micro- or macroalbuminuria (hazard ratio, 0.63","['patients with CKD in LEADER', '2158 patients had CKD versus 7182 without CKD (defined as eGFR <60 versus ≥60 ml/min per 1.73 m 2 , respectively); 966 patients had macroalbuminuria and 2456 had microalbuminuria', 'Type 2 Diabetes and Chronic Kidney Disease', 'patients with CKD or with micro- or macroalbuminuria (hazard ratio, 0.63', '9340 patients', 'participants with CKD']","['Liraglutide', 'liraglutide', 'liraglutide or placebo', 'placebo']","['Risk of severe hypoglycemia', 'mean eGFR', 'Overall, serious adverse events', 'adverse events', 'urine albumin-creatinine ratio ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C1654921', 'cui_str': 'Macroalbuminuria'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria (finding)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4517468', 'cui_str': '0.63'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042037'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",9340.0,0.224318,"Risk of severe hypoglycemia was significantly reduced with liraglutide versus placebo in patients with CKD or with micro- or macroalbuminuria (hazard ratio, 0.63","[{'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Center, Munich, Germany; prof.j.mann@gmail.com.'}, {'ForeName': 'Vivian A', 'Initials': 'VA', 'LastName': 'Fonseca', 'Affiliation': 'Tulane University Health Sciences Center, School of Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Poulter', 'Affiliation': 'School of Public Health, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Hadassah Hebrew University Hospital, Jerusalem, Israel; and.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Idorn', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Bernt Johan', 'Initials': 'BJ', 'LastName': 'von Scholten', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Hadassah Hebrew University Hospital, Jerusalem, Israel; and.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.11881019']
216,30747612,Utility-weighted modified Rankin Scale: Still too crude to be a truly patient-centric primary outcome measure?,"BACKGROUND


The utility-weighted modified Rankin Scale (UW-mRS) is an outcome measure recently proposed to improve statistical efficiency and interpretability of the mRS. Statistical properties of the UW-mRS have been well investigated, but construct validity has yet to be established.
AIMS


To investigate the construct validity of the UW-mRS as a primary outcome measure by assessing variability in utility values within and between mRS categories, over time post-stroke, and by different derivation methods.
METHODS


UW-mRS was derived using assessment of quality of life (AQoL-4D) and mRS scores at 3 and 12 months ( n  = 2030) from a large randomized controlled trial, A Very Early Rehabilitation Trial (AVERT). Receiver operator characteristic (ROC) analysis of AQoL-4D was conducted to differentiate between sequential mRS categories. Intraclass correlation was used to explore variability in utility values over time post-stroke, UW-mRS values, and derivation methods from multiple studies.
RESULTS


UW-mRS values for mRS categories 0-6 at three months were 0.80, 0.78, 0.63, 0.37, 0.11, 0.03, and 0. Based on AQoL-4D utility values, areas under the ROC curve varied from 0.54 to 0.87. Time post-stroke explained 42%-56% of variability in AQoL-4D utility values in patients with no change in mRS between 3 and 12 months. The choice of the derivation method contributed to 25% of the variability in UW-mRS values.
CONCLUSIONS


The high variability in utility values between and within mRS categories, over time post-stroke, and using different derivation methods is not adequately reflected in the UW-mRS. These threats to construct validity warrant caution when using UW-mRS as a primary outcome measure.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ACTRN12606000185561).",2020,"RESULTS


UW-mRS values for mRS categories 0-6 at three months were 0.80, 0.78, 0.63, 0.37, 0.11, 0.03, and 0.",[],['weighted modified Rankin Scale (UW-mRS'],"['Utility-weighted modified Rankin Scale', 'AQoL-4D utility values, areas under the ROC curve', 'quality of life (AQoL-4D) and mRS scores']",[],"[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.179505,"RESULTS


UW-mRS values for mRS categories 0-6 at three months were 0.80, 0.78, 0.63, 0.37, 0.11, 0.03, and 0.","[{'ForeName': 'Venesha', 'Initials': 'V', 'LastName': 'Rethnam', 'Affiliation': 'NHMRC Centre for Research Excellence in Stroke Rehabilitation and Brain Recovery, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bernhardt', 'Affiliation': 'NHMRC Centre for Research Excellence in Stroke Rehabilitation and Brain Recovery, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dewey', 'Affiliation': 'Eastern Health and Eastern Health Clinical School, Monash University, Clayton, Australia.'}, {'ForeName': 'Marj', 'Initials': 'M', 'LastName': 'Moodie', 'Affiliation': 'Deakin Health Economics, Deakin University, Burwood, Australia.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Johns', 'Affiliation': 'NHMRC Centre for Research Excellence in Stroke Rehabilitation and Brain Recovery, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Deakin Health Economics, Deakin University, Burwood, Australia.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Collier', 'Affiliation': 'NHMRC Centre for Research Excellence in Stroke Rehabilitation and Brain Recovery, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Ellery', 'Affiliation': 'NHMRC Centre for Research Excellence in Stroke Rehabilitation and Brain Recovery, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'NHMRC Centre for Research Excellence in Stroke Rehabilitation and Brain Recovery, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493019830583']
217,31930993,Health resource utilization of labor induction versus expectant management.,"BACKGROUND


Although induction of labor of low-risk nulliparous women at 39 weeks reduces the risk of cesarean delivery compared with expectant management, concern regarding more frequent use of labor induction remains, given that this intervention historically has been thought to incur greater resource utilization.
OBJECTIVE


The objective of the study was to determine whether planned elective labor induction at 39 weeks among low-risk nulliparous women, compared with expectant management, was associated with differences in health care resource utilization from the time of randomization through 8 weeks postpartum.
STUDY DESIGN


This is a planned secondary analysis of a multicenter randomized trial in which low-risk nulliparous women were assigned to induction of labor at 39 weeks or expectant management. We assessed resource utilization after randomization in 3 time periods: antepartum, delivery admission, and discharge through 8 weeks postpartum.
RESULTS


Of 6096 women with data available, those in the induction of labor group (n = 3059) were significantly less likely in the antepartum period after randomization to have at least 1 ambulatory visit for routine prenatal care (32.4% vs 68.4%), unanticipated care (0.5% vs 2.6%), or urgent care (16.2% vs 44.3%), or at least 1 antepartum hospitalization (0.8% vs 2.2%, P < .001 for all). They also had fewer tests (eg, sonograms, blood tests) and treatments (eg, antibiotics, intravenous hydration) prior to delivery. During the delivery admission, women in the induction of labor group spent a longer time in labor and delivery (median, 0.83 vs 0.57 days), but both women (P = .002) and their neonates (P < .001) had shorter postpartum stays. Women and neonates in both groups had similar frequencies of postpartum urgent care and hospital readmissions (P > .05 for all).
CONCLUSION


Women randomized to induction of labor had longer durations in labor and delivery but significantly fewer antepartum visits, tests, and treatments and shorter maternal and neonatal hospital durations after delivery. These results demonstrate that the health outcome advantages associated with induction of labor are gained without incurring uniformly greater health care resource use.",2020,"Women and neonates in both groups had similar frequencies of PP urgent care and hospital readmissions (p>0.05 for all).
","['low-risk nulliparous women', '6096 women with data available, those in the IOL group (n = 3059']","['labor induction versus expectant management', 'planned elective labor induction']","['antepartum (AP), delivery admission, and discharge through 8 weeks postpartum (PP', 'antepartum hospitalization', 'urgent care', 'PP urgent care and hospital readmissions', 'unanticipated care', 'longer time in labor and delivery', 'shorter maternal and neonatal hospital durations post-delivery', 'shorter postpartum stays', 'longer durations in labor and delivery']","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C2585455', 'cui_str': 'Expectant management (procedure)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0456336', 'cui_str': 'Antepartum (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2362545', 'cui_str': 'Urgent Care'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}]",,0.11091,"Women and neonates in both groups had similar frequencies of PP urgent care and hospital readmissions (p>0.05 for all).
","[{'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': 'Departments of Obstetrics and Gynecology, Northwestern University, Chicago, IL. Electronic address: w-grobman@northwestern.edu.'}, {'ForeName': 'Grecio', 'Initials': 'G', 'LastName': 'Sandoval', 'Affiliation': 'George Washington University Biostatistics Center, Washington, DC.'}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'University of Utah Health Sciences Center, Salt Lake City, UT.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mallett', 'Affiliation': 'Departments of Obstetrics and Gynecology, Northwestern University, Chicago, IL.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': 'University of Utah Health Sciences Center, Salt Lake City, UT.'}, {'ForeName': 'Madeline Murguia', 'Initials': 'MM', 'LastName': 'Rice', 'Affiliation': 'George Washington University Biostatistics Center, Washington, DC.'}, {'ForeName': 'Yasser Y', 'Initials': 'YY', 'LastName': 'El-Sayed', 'Affiliation': 'Stanford University, Stanford, CA.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': 'Columbia University, New York, NY.'}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': 'Brown University, Providence, RI.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': 'University of Texas Medical Branch, Galveston, TX.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': ""University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, TX.""}, {'ForeName': 'Jay D', 'Initials': 'JD', 'LastName': 'Iams', 'Affiliation': 'Ohio State University, Columbus, OH.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': 'MetroHealth Medical Center-Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Gibbs', 'Affiliation': 'University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Duke University, Durham, NC.'}, {'ForeName': 'Hyagriv N', 'Initials': 'HN', 'LastName': 'Simhan', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': 'Washington University, Saint Louis, MO.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.01.002']
218,32088207,A Randomized Placebo-Controlled Trial of Secukinumab on Aortic Vascular Inflammation in Moderate-to-Severe Plaque Psoriasis (VIP-S).,"Psoriasis, a chronic immune-mediated disease, is associated with an increased risk of cardiovascular events and mortality. Secukinumab selectively neutralizes IL-17A and has reported high efficacy with a favorable safety profile in various psoriatic disease manifestations. Subsequent to the 12-week randomized, placebo-controlled, double-blind treatment period, patients with moderate-to-severe psoriasis received secukinumab for 40 weeks. Vascular inflammation using  18 F-2-fluorodeoxyglucose-positron emission tomography/computed tomography imaging and blood-based cardiometabolic was assessed at week 0, 12, and 52. The difference in change in aortic inflammation from baseline to week 12 for secukinumab (n = 46) versus placebo (n = 45) was -0.053 (95% confidence interval = -0.169 to 0.064; P= 0.37). Small increases in total cholesterol, low-density lipoprotein, and low-density lipoprotein particles, but no changes in markers of inflammation, adiposity, insulin resistance, or predictors of diabetes, were observed with secukinumab treatment compared with placebo. At week 52, reductions in TNF-α (P= 0.0063) and ferritin (P= 0.0354), and an increase in fetuin-A (P= 0.0024), were observed with secukinumab treatment compared with baseline. No significant changes in aortic inflammation or markers of advanced lipoprotein characterization, adiposity, or insulin resistance were observed with secukinumab treatment compared with baseline. Secukinumab exhibited a neutral impact on aortic vascular inflammation and biomarkers of cardiometabolic disease after 52 weeks of treatment.",2020,"At Week 52, reductions in TNF-α (P=0.0063) and ferritin (P=0.0354), and an increase in fetuin A (P=0.0024), were observed with secukinumab treatment compared to baseline.","['Moderate to Severe Plaque Psoriasis (VIP-S', 'moderate-to-severe psoriasis patients received secukinumab for 40 weeks']","['placebo', 'Secukinumab', 'Placebo']","['Aortic Vascular Inflammation', 'aortic vascular inflammation and biomarkers of cardiometabolic disease', 'TNF-α', 'aortic inflammation', 'markers of inflammation, adiposity, insulin resistance, or predictors of diabetes', 'total cholesterol, LDL, and LDL particles', 'aortic inflammation or markers of advanced lipoprotein characterization, adiposity, or insulin resistance', 'Vascular inflammation using FDG-PET/CT imaging and blood-based cardiometabolic']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0042395', 'cui_str': 'VIP'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}]","[{'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0947751', 'cui_str': 'Vascular inflammations'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0005768'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",,0.536985,"At Week 52, reductions in TNF-α (P=0.0063) and ferritin (P=0.0354), and an increase in fetuin A (P=0.0024), were observed with secukinumab treatment compared to baseline.","[{'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Gelfand', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA. Electronic address: Joel.Gelfand@pennmedicine.upenn.edu.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Shin', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Kristina Callis', 'Initials': 'KC', 'LastName': 'Duffin', 'Affiliation': 'University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'April W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'Keck School of Medicine of USC, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, Oregon, USA.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Tyring', 'Affiliation': 'Department of Dermatology, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Division of Dermatology, Baylor Scott &White, Dallas, Texas, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Gottlieb', 'Affiliation': 'Dermatology and Skin Surgery Center, Exton, Pennsylvania, USA.'}, {'ForeName': 'Benjamin N', 'Initials': 'BN', 'LastName': 'Lockshin', 'Affiliation': 'DermAssociates, Rockville, Maryland, USA.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'OSHU Dermatology Clinic, South Waterfront, Portland, Oregon, USA.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Kianifard', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Rajendra Prasad', 'Initials': 'RP', 'LastName': 'Sarkar', 'Affiliation': 'Novartis Business Services, Novartis Healthcare Pvt Ltd, Hyderabad, India.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Muscianisi', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Steadman', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Ahlman', 'Affiliation': 'Radiology and Imaging Sciences, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Playford', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Aditya A', 'Initials': 'AA', 'LastName': 'Joshi', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Amit K', 'Initials': 'AK', 'LastName': 'Dey', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Werner', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Abass', 'Initials': 'A', 'LastName': 'Alavi', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Nehal N', 'Initials': 'NN', 'LastName': 'Mehta', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2020.01.025']
219,32259266,Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol.,"Importance


The risk of developing a surgical site infection after extremity fracture repair is nearly 5 times greater than in most elective orthopedic surgical procedures. For all surgical procedures, it is standard practice to prepare the operative site with an antiseptic solution; however, there is limited evidence to guide the choice of solution used for orthopedic fracture repair.
Objective


To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair.
Design, Setting, and Participants


The PREP-IT (Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma) master protocol will be followed to conduct 2 multicenter pragmatic cluster randomized crossover trials, Aqueous-PREP (Pragmatic Randomized Trial Evaluating Pre-Operative Aqueous Antiseptic Skin Solution in Open Fractures) and PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities). The Aqueous-PREP trial will compare 4% aqueous chlorhexidine vs 10% povidone-iodine for patients with open extremity fractures. The PREPARE trial will compare 2% chlorhexidine in 70% isopropyl alcohol vs 0.7% iodine povacrylex in 74% isopropyl alcohol for patients with open extremity fractures and patients with closed lower extremity or pelvic fractures. Both trials will share key aspects of study design and trial infrastructure. The studies will follow a pragmatic cluster randomized crossover design with alternating treatment periods of approximately 2 months. The primary outcome will be surgical site infection and the secondary outcome will be unplanned fracture-related reoperations within 12 months. The Aqueous-PREP trial will enroll a minimum of 1540 patients with open extremity fractures from at least 12 hospitals; PREPARE will enroll a minimum of 1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals. The primary analyses will adhere to the intention-to-treat principle and account for potential between-cluster and between-period variability. The patient-centered design, implementation, and dissemination of results are guided by a multidisciplinary team that includes 3 patients and other relevant stakeholders.
Discussion


The PREP-IT master protocol increases efficiency through shared trial infrastructure and study design components. Because prophylactic skin antisepsis is used prior to all surgical procedures and the application, cost, and availability of all study solutions are similar, the results of the PREP-IT trials are poised to inform clinical guidelines and bring about an immediate change in clinical practice.
Trial Registration


ClinicalTrials.gov Identifiers: NCT03385304 and NCT03523962.",2020,"To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair.
","['patients who underwent fracture repair', '1540 patients with open extremity fractures from at least 12 hospitals', 'patients with open extremity fractures and patients with closed lower extremity or pelvic fractures', 'patients with open extremity fractures', '1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals', 'Patients', 'Open Fractures', 'Fractured Extremities']","['Pre-Operative Aqueous Antiseptic Skin Solution', 'isopropyl alcohol', 'chlorhexidine', 'Fracture Repair', 'Iodophor vs Chlorhexidine Solutions', 'iodophor vs chlorhexidine solutions', 'isopropyl alcohol vs 0.7% iodine povacrylex', 'povidone-iodine']","['surgical site infection', 'unplanned fracture-related reoperations', 'surgical site infections and unplanned fracture-related reoperations', 'Surgical Site Infections and Unplanned Reoperations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3805218', 'cui_str': 'Fracture repair'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0149531', 'cui_str': 'Fracture of pelvis'}, {'cui': 'C0016662', 'cui_str': 'Fracture, open'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0022237', 'cui_str': 'Isopropyl Alcohol'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C3805218', 'cui_str': 'Fracture repair'}, {'cui': 'C0021988', 'cui_str': 'Iodophors'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C1876049', 'cui_str': 'iodine povacrylex'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",6280.0,0.141164,"To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Gerard P', 'Initials': 'GP', 'LastName': 'Slobogean', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Wells', 'Affiliation': 'Trauma Survivors Network, Falls Church, Virginia.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Rojas', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alisha', 'Initials': 'A', 'LastName': 'Garibaldi', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Wood', 'Affiliation': 'Association of periOperative Registered Nurses, Denver, Colorado.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Howe', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Harris', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Petrisor', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Mullins', 'Affiliation': 'Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pogorzelski', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Marvel', 'Affiliation': 'Patient Advisor, Baltimore, Maryland.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Mossuto', 'Affiliation': 'Hamilton Health Science, Hamilton, Ontario, Canada.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Grissom', 'Affiliation': 'Trauma Survivor Network, Baltimore, Maryland.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Del Fabbro', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Gordon H', 'Initials': 'GH', 'LastName': 'Guyatt', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Della Rocca', 'Affiliation': 'Department of Orthopaedic Surgery, University of Missouri, Columbia.'}, {'ForeName': 'Haley K', 'Initials': 'HK', 'LastName': 'Demyanovich', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'I Leah', 'Initials': 'IL', 'LastName': 'Gitajn', 'Affiliation': 'Department of Orthopaedics, Dartmouth University, Hanover, New Hampshire.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Palmer', 'Affiliation': 'Patient Advisor, Baltimore, Maryland.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': ""D'Alleyrand"", 'Affiliation': 'Department of Orthopaedic Surgery, Walter Reed National Military Medical Center, Bethesda, Maryland.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Friedrich', 'Affiliation': 'Washington, DC.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Rivera', 'Affiliation': 'Department of Orthopaedic Surgery, San Antonio Military Medical Center, San Antonio, Texas.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Hebden', 'Affiliation': 'Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Rudnicki', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Fowler', 'Affiliation': 'Department of Orthopaedic Surgery, San Antonio Military Medical Center, San Antonio, Texas.'}, {'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'Jeray', 'Affiliation': 'Department of Orthopaedic Surgery, Greenville Health System, Greenville, South Carolina.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Marchand', 'Affiliation': 'Department of Orthopaedic Surgery, University of Utah, Salt Lake City.'}, {'ForeName': 'Lyndsay M', 'Initials': 'LM', 'LastName': ""O'Hara"", 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Manjari G', 'Initials': 'MG', 'LastName': 'Joshi', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Talbot', 'Affiliation': 'Canadian Armed Forces, Montreal, Qubec, Canada.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Camara', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Olivia Paige', 'Initials': 'OP', 'LastName': 'Szasz', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Nathan N', 'Initials': 'NN', 'LastName': ""O'Hara"", 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'McKay', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Devereaux', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert V', 'Initials': 'RV', 'LastName': ""O'Toole"", 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zura', 'Affiliation': 'Department of Orthopaedics, Louisiana State University Health, New Orleans.'}, {'ForeName': 'Saam', 'Initials': 'S', 'LastName': 'Morshed', 'Affiliation': 'Department of Orthopaedic Surgery, University of California, San Francisco.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Dodds', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Tanner', 'Affiliation': 'Department of Orthopaedic Surgery, Greenville Health System, Greenville, South Carolina.'}, {'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Scott', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Uyen', 'Initials': 'U', 'LastName': 'Nguyen', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.2215']
220,32270440,Imeglimin Does Not Induce Clinically Relevant Pharmacokinetic Interactions When Combined with Either Metformin or Sitagliptin in Healthy Subjects.,"BACKGROUND AND OBJECTIVES


Imeglimin (IMEG) is the first in a novel class of oral glucose-lowering agents with a unique mechanism of action targeting mitochondrial bioenergetics. We assessed whether repeated co-administration of IMEG and either metformin (MET) or sitagliptin (SITA) would influence the pharmacokinetics of either MET or SITA in healthy Caucasian men.
METHODS


Healthy Caucasian men received either MET 850 mg twice daily with placebo (n = 16) or SITA 100 mg once daily with placebo (n = 16) on days 1-6, followed by MET 850 mg twice daily with IMEG 1500 mg twice daily or SITA 100 mg once daily with IMEG 1500 mg twice daily on days 7-12. Pharmacokinetic parameters were determined from blood and urine; levels of all compounds were evaluated using liquid chromatography with tandem mass spectrometry.
RESULTS


Systemic exposure (AUC 0-τ  area under the plasma concentration-time curve over a dosing interval and maximum concentration) to MET was 14% and 10% lower, respectively, when administered with IMEG. Approximately 40% of MET was excreted unchanged in urine, decreasing to 34% when given with IMEG. The 90% confidence intervals for AUC 0-τ  and maximum concentration indicated no effect of co-administration on systemic exposure to MET. Mean AUC 0-τ  and maximum concentration of SITA were similar with or without IMEG. Median times to maximum concentration were 0.7 and 1.0 h and mean elimination half-lives were 8.2 and 8.7 h with and without IMEG, respectively. Systemic exposure to IMEG was similar to previous phase I studies.
CONCLUSIONS


Co-administration of IMEG with MET or SITA did not result in clinically relevant changes in systemic exposure to MET or SITA, although minor reductions in exposure (AUC 0-τ  and maximum concentration) and renal elimination were noted when MET was given with IMEG vs placebo.
CLINICAL TRIAL REGISTRATION


EudraCT2009-014520-40 (MET-IMEG DDI) and EudraCT2010-022926-34 (SITA-IMEG DDI).",2020,The 90% confidence intervals for AUC 0-τ  and maximum concentration indicated no effect of co-administration on systemic exposure to MET.,"['healthy Caucasian men', 'Healthy Caucasian men', 'Healthy Subjects']","['IMEG and either metformin (MET) or sitagliptin (SITA', 'MET 850\xa0mg twice daily with IMEG 1500\xa0mg twice daily or SITA 100', 'MET 850\xa0mg twice daily with placebo', 'SITA 100\xa0mg once daily with placebo', 'Metformin', 'IMEG', 'Imeglimin (IMEG', 'IMEG 1500']","['Systemic exposure (AUC 0-τ  area under the plasma concentration-time curve', 'Mean AUC 0-τ  and maximum concentration of SITA', 'Median times to maximum concentration', 'exposure (AUC 0-τ  and maximum concentration) and renal elimination']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C3840657', 'cui_str': '850'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C3501765', 'cui_str': 'imeglimin'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1373187', 'cui_str': 'Renal Excretion'}]",,0.218336,The 90% confidence intervals for AUC 0-τ  and maximum concentration indicated no effect of co-administration on systemic exposure to MET.,"[{'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Fouqueray', 'Affiliation': 'Poxel SA, 259/261 Avenue Jean Jaurès, 69007, Lyon, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Perrimond-Dauchy', 'Affiliation': 'Poxel SA, 259/261 Avenue Jean Jaurès, 69007, Lyon, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Bolze', 'Affiliation': 'Poxel SA, 259/261 Avenue Jean Jaurès, 69007, Lyon, France. sebastien.bolze@poxelpharma.com.'}]",Clinical pharmacokinetics,['10.1007/s40262-020-00886-y']
221,32277344,Comparable Effect of Two-Step Versus Extended Infusions on the Pharmacokinetics of Imipenem in Patients with Sepsis and Septic Shock.,"INTRODUCTION


The present study aimed to compare the pharmacokinetic/pharmacodynamic (PK/PD) parameters of imipenem administered by two-step (50% delivered in a 30-min bolus, 50% for the following 90 min) or extended (administered continuously for 2 h) infusion.
METHODS


Patients with sepsis and septic shock were prospectively enrolled and randomized into four groups. Subjects in the two-step or extended groups were given two doses of imipenem (0.5 g q6h and 1.0 g q8h). The plasma imipenem concentrations were measured at given time points after the fifth dose. The PK/PD target was defined as the achievement of a fractional time above the minimal inhibitory concentration (MIC) of > 40%.
RESULTS


Thirty-five patients were eventually enrolled. No significant difference was observed in the percentage of patients achieving 40% T > MIC between the different infusion modes with the same dosage, although the two-step groups exhibited a significantly shorter T max  compared with the extended groups (0.5 g q6h: 1.5 ± 0.8 vs. 2.0 ± 0.0 h; 1.0 g q8h: 1.0 ± 0.6 vs. 2.0 ± 0.0 h; both, p < 0.05). All four groups achieved 40% T > MIC when MIC was 0.5-4.0 μg/ml, but only regimens with a higher dose (1.0 g q8h) achieved target when MIC was 8 μg/ml.
CONCLUSION


The two-step and extended regimens of imipenem are comparable to the PK/PD target in the treatment of sepsis and septic shock. A higher dose (1.0 g q8h) should be considered for target achievement at an MIC of > 8 μg/ml.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02616354.",2020,"No significant difference was observed in the percentage of patients achieving 40% T > MIC between the different infusion modes with the same dosage, although the two-step groups exhibited a significantly shorter T max  compared with the extended groups (0.5 g q6h: 1.5 ± 0.8 vs. 2.0 ± 0.0 h; 1.0 g q8h: 1.0 ± 0.6 vs. 2.0 ± 0.0 h; both, p < 0.05).","['Patients with Sepsis and Septic Shock', 'Patients with sepsis and septic shock', 'Thirty-five patients were eventually enrolled']","['Imipenem', 'imipenem']","['plasma imipenem concentrations', 'pharmacokinetic/pharmacodynamic (PK/PD) parameters', 'percentage of patients achieving 40% T\u2009>\u2009MIC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C4319605', 'cui_str': '35'}]","[{'cui': 'C0020933', 'cui_str': 'Imipenem'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0020933', 'cui_str': 'Imipenem'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}]",35.0,0.14188,"No significant difference was observed in the percentage of patients achieving 40% T > MIC between the different infusion modes with the same dosage, although the two-step groups exhibited a significantly shorter T max  compared with the extended groups (0.5 g q6h: 1.5 ± 0.8 vs. 2.0 ± 0.0 h; 1.0 g q8h: 1.0 ± 0.6 vs. 2.0 ± 0.0 h; both, p < 0.05).","[{'ForeName': 'Yingzi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Pharmacy Department, Hospital for Skin Diseases, Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': 'Pharmacy Department, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Zha', 'Affiliation': 'Pharmacy Department, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Songqiao', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Shao', 'Affiliation': 'Pharmacy Department, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China. yiyiyang2004@163.com.'}]",Advances in therapy,['10.1007/s12325-020-01339-5']
222,32247311,Community initiated kangaroo mother care and early child development in low birth weight infants in India-a randomized controlled trial.,"BACKGROUND


In a randomized controlled trial (RCT) with 8402 stable low birthweight (LBW) infants, majority being late preterm or term small for gestational age, community-initiated KMC (ciKMC) showed a significant improvement in survival. However, the effect of ciKMC on neurodevelopment is unclear. This is important to elucidate as children born with low birth weight are at high risk of neurodevelopmental deficits. In the first 552 stable LBW infants enrolled in the above trial, we evaluated the effect of ciKMC on neurodevelopmental outcomes during infancy.
METHOD


This RCT was conducted among 552 stable LBW infants, majorly late preterm or term small for gestational age infants without any problems at birth and weighing 1500-2250 g at birth. The intervention comprised of promotion of skin-to-skin contact and exclusive breastfeeding by trained intervention delivery team through home visits. The intervention group mother-infant-dyads were supported to practice ciKMC till day 28 after birth or until the baby wriggled-out. All infants in the intervention and control groups received Home Based Post Natal Care (HBPNC) visits by government health workers. Cognitive, language, motor and socio-emotional outcomes were assessed at infant-ages 6- and 12-months using Bayley Scale of Infant Development (BSID-III). Other outcomes measured were infant temperament, maternal depression, maternal sense of competence, mother-infant bonding and home-environment. We performed post-hoc equivalence testing using two one-sided tests of equivalence (TOST) to provide evidence that ciKMC does not do harm in terms of neurodevelopment.
RESULTS


In the intervention arm, the median (IQR) time to initiate ciKMC was 48 (48 to 72) hours after birth. The mean (SD) duration of skin-to-skin-contact was 27.9 (3.9) days with a mean (SD) of 8.7 (3.5) hours per day. We did not find significant effect of ciKMC on any of the child developmental outcomes during infancy. The TOST analysis demonstrated that composite scores for cognitive, language and motor domains at 12 months among the study arms were statistically equivalent.
CONCLUSION


Our study was unable to capture any effect of ciKMC on neurodevelopment during infancy in this sample of stable late preterm or term small for gestational age infants. Long term follow-up may provide meaningful insights.
TRIAL REGISTRATION


The trial is registered at clinicaltrials.gov NCT02631343 dated February 17, 2016; Retrospectively registered.",2020,All infants in the intervention and control groups received Home Based Post Natal Care (HBPNC) visits by government health workers.,"['children born with low birth weight', '552 stable LBW infants enrolled in the above trial', 'low birth weight infants in India', 'stable late preterm or term small for gestational age infants', 'registered at clinicaltrials.gov NCT02631343 dated February 17, 2016; Retrospectively registered', '552 stable LBW infants, majorly late preterm or term small for gestational age infants without any problems at birth and weighing 1500-2250\u2009g at birth']","['Home Based Post Natal Care (HBPNC) visits by government health workers', 'ciKMC', 'promotion of skin-to-skin contact and exclusive breastfeeding by trained intervention delivery team through home visits']","['neurodevelopmental outcomes', 'Cognitive, language, motor and socio-emotional outcomes', 'mean (SD) duration of skin-to-skin-contact', 'survival', 'composite scores for cognitive, language and motor domains', 'median (IQR) time to initiate ciKMC', 'Bayley Scale of Infant Development (BSID-III', 'infant temperament, maternal depression, maternal sense of competence, mother-infant bonding and home-environment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021288', 'cui_str': 'Low birth weight infant'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021296', 'cui_str': 'Small-for-dates baby'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C4517582', 'cui_str': '1500'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}]","[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",8402.0,0.162231,All infants in the intervention and control groups received Home Based Post Natal Care (HBPNC) visits by government health workers.,"[{'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Taneja', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi, 110016, India. sunita.taneja@sas.org.in.'}, {'ForeName': 'Bireshwar', 'Initials': 'B', 'LastName': 'Sinha', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi, 110016, India.'}, {'ForeName': 'Ravi Prakash', 'Initials': 'RP', 'LastName': 'Upadhyay', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi, 110016, India.'}, {'ForeName': 'Sarmila', 'Initials': 'S', 'LastName': 'Mazumder', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi, 110016, India.'}, {'ForeName': 'Halvor', 'Initials': 'H', 'LastName': 'Sommerfelt', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Martines', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Suresh Kumar', 'Initials': 'SK', 'LastName': 'Dalpath', 'Affiliation': 'State Health System Resource Centre, Haryana, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of School Education, Government of Haryana, Panchkula, India.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Kariger', 'Affiliation': 'Center for Effective Global Health, University of California, Berkeley, USA.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Bahl', 'Affiliation': 'Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Bhandari', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi, 110016, India.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Dua', 'Affiliation': 'Department of Mental Health and Substance Abuse, World Health Organization, Geneva, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pediatrics,['10.1186/s12887-020-02046-4']
223,31590108,Randomized controlled trial of cryotherapy to prevent paclitaxel-induced peripheral neuropathy (RU221511I); an ACCRU trial.,"PURPOSE


This pilot trial aimed to assess if cooling hands and feet with crushed ice during receipt of paclitaxel helps prevent peripheral neuropathy.
METHODS


This prospective, randomized trial compared cryotherapy to standard care in patients initiating paclitaxel weekly x 12. For those on cryotherapy, hands and feet were cooled starting 15 min prior to and ending 15 min after each paclitaxel dose. EORTC QLQ-CIPN20 was completed at baseline, weekly x12, then monthly x6. Area under the curve (AUC) was calculated for subscale scores, adjusting for baseline, and compared between arms (Wilcoxon rank-sum test). Cross-study comparisons used data from 2 prior similarly-conducted neuropathy trials.
RESULTS


Forty-six patients were accrued. Three withdrew and one was ineligible. Of the remaining 42 (21 cryotherapy, 21 control), 39 (19 cryotherapy, 20 control) were analyzable for AUC. Cryotherapy was well tolerated, but the AUC of the CIPN20 sensory scores over 12 weeks of paclitaxel was not found to differ between the study arms (mean difference 3.45, 95% CI -3.13 to 10.02, p = 0.26). However, the control arm of the current trial experienced less neuropathy than did the placebo arms of two previous similar trials. When our cryotherapy arm was compared to the combined control arms from all three trials, the cryotherapy arm had less neuropathy (Wilcoxon Rank-Sum p = 0.01).
CONCLUSION


While there was no difference in CIPN20 scores identified between the 2 study arms in the current phase II trial, further investigation is needed given that the control arm experienced less neuropathy than was expected.",2019,"Cryotherapy was well tolerated, but the AUC of the CIPN20 sensory scores over 12 weeks of paclitaxel was not found to differ between the study arms (mean difference 3.45, 95% CI -3.13 to 10.02, p = 0.26).","['patients initiating paclitaxel weekly x 12', 'Forty-six patients were accrued']","['Cryotherapy', 'placebo', 'cryotherapy', 'paclitaxel']","['CIPN20 scores', 'Area under the curve (AUC', 'CIPN20 sensory scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}]",46.0,0.0622765,"Cryotherapy was well tolerated, but the AUC of the CIPN20 sensory scores over 12 weeks of paclitaxel was not found to differ between the study arms (mean difference 3.45, 95% CI -3.13 to 10.02, p = 0.26).","[{'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ruddy', 'Affiliation': 'Department of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. Electronic address: Ruddy.kathryn@mayo.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Le-Rademacher', 'Affiliation': 'Department of Biostatistics, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Mario E', 'Initials': 'ME', 'LastName': 'Lacouture', 'Affiliation': 'Department of Dermatology, Memorial Sloan Kettering Cancer Center, 1275 York Ave., New York, NY, 10065, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Wilkinson', 'Affiliation': 'Inova Hematology Oncology, 8501 Arlington Blvd., Suite 340, Fairfax, VA, 22031, USA.'}, {'ForeName': 'Adedayo A', 'Initials': 'AA', 'LastName': 'Onitilo', 'Affiliation': 'Marshfield Clinic - Weston Center, 3501 Cranberry Blvd., Weston, WI, 54476, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Vander Woude', 'Affiliation': 'Cancer and Hematology Centers of Western Michigan, 145 Michigan St. NE, #3100, Grand Rapids, MI, 49503, USA.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Grosse-Perdekamp', 'Affiliation': 'Carle Cancer Center, 509 W. University Ave., Urbana, IL, 61801, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Dockter', 'Affiliation': 'Department of Biostatistics, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Angelina D', 'Initials': 'AD', 'LastName': 'Tan', 'Affiliation': 'Department of Biostatistics, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Beutler', 'Affiliation': 'Department of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Loprinzi', 'Affiliation': 'Department of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2019.09.011']
224,32274521,The Effects of home-based stabilization exercises focusing on the pelvic floor on postnatal stress urinary incontinence and low back pain: a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS


Stress urinary incontinence (SUI) and low back pain (LBP) are common postnatal problems. We aimed to compare the effects of stabilization exercises focusing on the pelvic floor on postnatal SUI and LBP.
METHODS


This two-arm, single-blind, parallel, randomized controlled trial was done on 80 women (mean age: 30.5, range: 20-45 years), with postnatal SUI and LBP. They were randomized into two equal control and intervention groups. The control group received no treatment while the intervention group received home-based stabilization exercises focusing on pelvic floor muscles (PFM) 3 days a week for 12 weeks, three sets a day; each set included three different types of exercise each week. Outcome measures were UI severity, assessed by ICIQ-UI-SF, low back pain functional disability, assessed by the Oswestry Disability Index (ODI), LBP severity, assessed by visual analog scale (VAS), and PFM strength and endurance, assessed by vaginal examination. Transverse abdominis (TrA) muscle strength was assessed by manometric biofeedback. All outcomes were measured directly before and after treatment.
RESULTS


In the intervention group, PFM strength, TrA muscle strength, functional disability and pain severity were significantly improved (P < 0.05). Within-group results showed that all outcomes except pain severity (P = 0.06) had directly improved in the intervention group after treatment (P < 0.05), while in the control group only PFM strength and endurance and UI severity had improved (P < 0.05).
CONCLUSIONS


Home-based stabilization exercises focusing on the pelvic floor muscles could be effective for postnatal LBP and SUI.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials (Code: IRCT2017050618760N4).",2020,"In the intervention group, PFM strength, TrA muscle strength, functional disability and pain severity were significantly improved (P < 0.05).","['80 women (mean age: 30.5, range: 20-45\xa0years), with postnatal SUI and LBP', 'postnatal stress urinary incontinence and low back pain']","['home-based stabilization exercises', 'no treatment while the intervention group received home-based stabilization exercises focusing on pelvic floor muscles (PFM', 'stabilization exercises']","['Transverse abdominis (TrA) muscle strength', 'pain severity', 'UI severity, assessed by ICIQ-UI-SF, low back pain functional disability, assessed by the Oswestry Disability Index (ODI), LBP severity, assessed by visual analog scale (VAS), and PFM strength and endurance, assessed by vaginal examination', 'PFM strength and endurance and UI severity', 'PFM strength, TrA muscle strength, functional disability and pain severity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]","[{'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0200048', 'cui_str': 'Examination of vagina'}]",80.0,0.0753496,"In the intervention group, PFM strength, TrA muscle strength, functional disability and pain severity were significantly improved (P < 0.05).","[{'ForeName': 'Fahime', 'Initials': 'F', 'LastName': 'Khorasani', 'Affiliation': 'Department of Physiotherapy, Faculty of Rehabilitation, Tabriz University of Medical Sciences, Daneshgah Ave., Tabriz, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Ghaderi', 'Affiliation': 'Department of Physiotherapy, Faculty of Rehabilitation, Tabriz University of Medical Sciences, Daneshgah Ave., Tabriz, Iran. ghaderimailbox@gmail.com.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Bastani', 'Affiliation': ""Department of Gynaecology, Woman's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Sarbakhsh', 'Affiliation': 'Road Traffic Injury Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Bary', 'Initials': 'B', 'LastName': 'Berghmans', 'Affiliation': 'Pelvic care Centre Maastricht, Maastricht University Medical Centre, Maastricht, The Netherlands.'}]",International urogynecology journal,['10.1007/s00192-020-04284-7']
225,30303394,Memory training for adults with probable mild cognitive impairment: a pilot study.,"Background & Objectives:  This pilot study aimed to evaluate the efficacy of memory training and health training intervention over a 24-month period in people with probable mild cognitive impairment (MCI).  Research Design & Methods:  Based on the accepted criteria, and the neuropsychiatric measures used in the trial, MCI was defined as a subjective change in cognition, impairment in episodic memory, preservation of independence of functional abilities, and no dementia. Without a neurological assessment, laboratory tests, and psychometric evaluation combined, some of our participants may have had dementia that we were unable to detect through neuropsychological testing. Of the 263 total participants, 39 met criteria for a diagnosis of MCI. There were 19 adults in the memory and 20 in health training conditions. Both groups received twenty hours of classroom content that included eight hours of booster sessions at three months post intervention. Hierarchical linear models (HLM) and standardized regression-based (SBR) analyses were used to test the efficacy of the intervention on immediate recall, delayed recall, subjective memory complaints, and memory self-efficacy. Age, education, depression, racial group, ethnic group, MMSE score, and baseline performance were included as covariates.  Results:  Over 24 months, the MCI group in the memory training condition showed better objective and subjective memory outcomes compared with the MCI group in the health training condition.  Conclusions:  Senior WISE Memory training delivered to individuals with MCI was able to forestall the participants' declining cognitive ability and sustain the benefit over two years in both subjective and objective memory function.",2019,"Over 24 months, the MCI group in the memory training condition showed better objective and subjective memory outcomes compared with the MCI group in the health training condition.
","['263 total participants, 39 met criteria for a diagnosis of MCI', '19 adults in the memory and 20 in health training conditions', 'people with probable mild cognitive impairment (MCI', 'adults with probable mild cognitive impairment']","['Memory training', 'memory training and health training intervention', 'MCI']","['immediate recall, delayed recall, subjective memory complaints, and memory self-efficacy', 'objective and subjective memory outcomes', 'subjective change in cognition, impairment in episodic memory, preservation of independence of functional abilities, and no dementia']","[{'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0729377', 'cui_str': 'Memory Training'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}]","[{'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]",263.0,0.0296076,"Over 24 months, the MCI group in the memory training condition showed better objective and subjective memory outcomes compared with the MCI group in the health training condition.
","[{'ForeName': 'Graham J', 'Initials': 'GJ', 'LastName': 'McDougall', 'Affiliation': 'a College of Nursing, Florida State University , Tallahassee , USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'McDonough', 'Affiliation': 'b Department of Psychology, The University of Alabama , Tuscaloosa , USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'LaRocca', 'Affiliation': 'c War Related Illness and Injury Study Center, Veterans Administration Palo Alto Health Care System , Livermore , USA.'}]",Aging & mental health,['10.1080/13607863.2018.1484884']
226,31028547,Comparison of enhanced laparoscopic imaging techniques in endometriosis surgery: a diagnostic accuracy study.,"BACKGROUND


For surgical endometriosis, treatment key is to properly identify the peritoneal lesions. The aim of this clinical study was to investigate if advanced imaging improves the detection rate by comparing narrow-band imaging (NBI), near-infrared imaging with indocyanine green (NIR-ICG), or three-dimensional white-light imaging (3D), to conventional two-dimensional white-light imaging (2D) for the detection of peritoneal endometriotic lesions.
METHODS


This study was a prospective, single-center, randomized within-subject, clinical trial. The trial was conducted at Amsterdam UMC-Location VUmc, a tertiary referral hospital for endometriosis. 20 patients with ASRM stage III-IV endometriosis, scheduled for elective laparoscopic treatment of their endometriosis, were included. During laparoscopy, the pelvic region was systematically inspected with conventional 2D white-light imaging followed by inspection with NBI, NIR-ICG, and 3D imaging in a randomized order. Suspected endometriotic lesions and control biopsies of presumably healthy peritoneum were taken for histological examination. The pathologist was blinded for the method of laparoscopic detection. Sensitivity and specificity rates of the enhanced imaging techniques were analyzed. McNemar's test was used to compare sensitivity to 2D white-light imaging and Method of Tango to assess non-inferiority of specificity.
RESULTS


In total, 180 biopsies were taken (117 biopsies from lesions suspected for endometriosis; 63 control biopsies). 3D showed a significantly improved sensitivity rate (83.5% vs. 75.8%, p = 0.016) and a non-inferior specificity rate (82.4% vs. 84.7%, p = 0.009) when compared to 2D white-light imaging. The single use of NBI or NIR-ICG showed no improvement in the detection of endometriosis. Combining the results of 3D and NBI resulted in a sensitivity rate of 91.2% (p < 0.001).
CONCLUSION


Enhanced laparoscopic imaging with 3D white light, combined with NBI, improves the detection rate of peritoneal endometriosis when compared to conventional 2D white-light imaging. The use of these imaging techniques enables a more complete laparoscopic resection of endometriosis.",2020,"3D showed a significantly improved sensitivity rate (83.5% vs. 75.8%, p = 0.016) and a non-inferior specificity rate (82.4% vs. 84.7%, p = 0.009) when compared to 2D white-light imaging.","['endometriosis surgery', 'Amsterdam UMC-Location VUmc, a tertiary referral hospital for endometriosis', 'In total, 180 biopsies were taken (117 biopsies from lesions suspected for endometriosis; 63 control biopsies', '20 patients with ASRM stage III-IV endometriosis, scheduled for elective laparoscopic treatment of their endometriosis, were included']","['narrow-band imaging (NBI), near-infrared imaging with indocyanine green (NIR-ICG), or three-dimensional white-light imaging (3D), to conventional two-dimensional white-light imaging (2D', 'enhanced laparoscopic imaging techniques']","['detection of endometriosis', 'detection rate', 'sensitivity rate', 'detection rate of peritoneal endometriosis', 'non-inferior specificity rate', 'Sensitivity and specificity rates']","[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C1532326', 'cui_str': 'Infrared'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0563228', 'cui_str': 'White light (physical force)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0079595', 'cui_str': 'Imaging technique (qualifier value)'}]","[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",180.0,0.0895615,"3D showed a significantly improved sensitivity rate (83.5% vs. 75.8%, p = 0.016) and a non-inferior specificity rate (82.4% vs. 84.7%, p = 0.009) when compared to 2D white-light imaging.","[{'ForeName': 'Marit C I', 'Initials': 'MCI', 'LastName': 'Lier', 'Affiliation': 'Department of Reproductive Medicine, Endometriosis Center, Amsterdam UMC-Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Stijn L', 'Initials': 'SL', 'LastName': 'Vlek', 'Affiliation': 'Department of Surgery, Endometriosis Center, Amsterdam UMC-Location VUmc, De Boelelaan 1118, ZH7F20, 1081HZ, Amsterdam, The Netherlands. s.vlek@vumc.nl.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Ankersmit', 'Affiliation': 'Department of Surgery, Endometriosis Center, Amsterdam UMC-Location VUmc, De Boelelaan 1118, ZH7F20, 1081HZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC-Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith J M L', 'Initials': 'JJML', 'LastName': 'Dekker', 'Affiliation': 'Department of Reproductive Medicine, Endometriosis Center, Amsterdam UMC-Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Maaike C G', 'Initials': 'MCG', 'LastName': 'Bleeker', 'Affiliation': 'Department of Pathology, Endometriosis Center, Amsterdam UMC-Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Velja', 'Initials': 'V', 'LastName': 'Mijatovic', 'Affiliation': 'Department of Reproductive Medicine, Endometriosis Center, Amsterdam UMC-Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Jurriaan B', 'Initials': 'JB', 'LastName': 'Tuynman', 'Affiliation': 'Department of Surgery, Endometriosis Center, Amsterdam UMC-Location VUmc, De Boelelaan 1118, ZH7F20, 1081HZ, Amsterdam, The Netherlands.'}]",Surgical endoscopy,['10.1007/s00464-019-06736-8']
227,31033747,A Randomized Comparative Effectiveness Trial of Family-Problem-Solving Treatment for Adolescent Brain Injury: Parent Outcomes From the Coping with Head Injury through Problem Solving (CHIPS) Study.,"OBJECTIVE


To examine changes in depression and distress in parents of adolescents receiving family-problem-solving therapy (F-PST) following traumatic brain injury.
METHOD


Families of adolescents hospitalized for moderate to severe traumatic brain injury were randomized to face-to-face F-PST (34), therapist-guided online F-PST (56), or self-guided online F-PST (60). Outcomes were assessed pretreatment and 6 and 9 months later. Parents rated depression and distress on the Center for Epidemiological Studies Depression Scale and the Brief Symptom Inventory, respectively. Mixed modeling was used to examine changes over time and treatment moderators.
RESULTS


The therapist-guided online group had significant reductions in parental depression over time. Analyses of slopes of recovery revealed differential improvement on the Center for Epidemiological Studies Depression Scale between the 2 online groups, with no significant change in depressive symptoms following self-guided F-PST. On the Brief Symptom Inventory Global Severity Index, the therapist-guided online group reported significant improvement from baseline to 6 months that was maintained at 9 months. The face-to-face and self-guided online groups reported significant reductions in distress between 6 and 9 months with corresponding large effect sizes. Differences on the Center for Epidemiological Studies Depression Scale between therapist-guided and self-guided online groups at the 9-month follow-up were more pronounced in families of lower socioeconomic status, t103 = -2.87; P = .005.
CONCLUSIONS


Findings provide further support for the utility of therapist-guided online F-PST in reducing parental depression and distress following pediatric traumatic brain injury and offer limited evidence of the efficacy of self-guided online treatment for these outcomes. Families of lower socioeconomic status may benefit more from therapist involvement.",2019,"On the Brief Symptom Inventory Global Severity Index, the therapist-guided online group reported significant improvement from baseline to 6 months that was maintained at 9 months.","['parents of adolescents receiving family-problem-solving therapy (F-PST) following traumatic brain injury', 'Adolescent Brain Injury', 'Families of adolescents hospitalized for moderate to severe traumatic brain injury']","['face-to-face F-PST (34), therapist-guided online F-PST (56), or self-guided online F-PST (60', 'Family-Problem-Solving Treatment']","['Epidemiological Studies Depression Scale', 'depressive symptoms', 'Brief Symptom Inventory Global Severity Index', 'parental depression', 'depression and distress', 'distress']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0424960', 'cui_str': 'Family problems (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0424960', 'cui_str': 'Family problems (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",,0.0694972,"On the Brief Symptom Inventory Global Severity Index, the therapist-guided online group reported significant improvement from baseline to 6 months that was maintained at 9 months.","[{'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Wade', 'Affiliation': ""Division of Pediatric Rehabilitation Medicine, Cincinnati Children's Hospital Medical Center and Departments of Pediatrics and Psychology, University of Cincinnati, Cincinnati, Ohio (Dr Wade); Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio (Dr Cassedy); Division of Psychiatry and Behavioral Health, Nationwide Children's Hospital and The Ohio State University, Columbus, Ohio (Dr McNally); Division of Pediatric Rehabilitation Medicine, Cincinnati Children's Hospital Medical Center, and Departments of Pediatrics, Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, Ohio (Dr Kurowski); Department of Rehabilitation Psychology/Neuropsychology, Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, Colorado (Dr Kirkwood); Department of Psychiatry, Case Western Reserve University, MetroHealth Medical Center, Cleveland, Ohio (Dr Stancin); Center for Biobehavioral Health, Nationwide Children's Hospital Research Institute, Department of Pediatrics, The Ohio State University, Columbus, Ohio (Dr Taylor); and Division of Developmental/Behavioral Pediatrics and Psychology, Case Western Reserve University and Rainbow Babies & Children's University Hospital Cleveland Medical Center, Cleveland, Ohio (Dr Taylor).""}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Cassedy', 'Affiliation': ''}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'McNally', 'Affiliation': ''}, {'ForeName': 'Brad G', 'Initials': 'BG', 'LastName': 'Kurowski', 'Affiliation': ''}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Kirkwood', 'Affiliation': ''}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Stancin', 'Affiliation': ''}, {'ForeName': 'H Gerry', 'Initials': 'HG', 'LastName': 'Taylor', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000487']
228,30874292,The Effects of Two Different Burn Dressings on Serum Oxidative Stress Indicators in Children with Partial Burn.,"In this study, we evaluated and compared the effect of treatment with a hydrofiber dressing with silver (HFAg) and a polylactic membrane (PLM) on systemic oxidative stress in systemic inflammatory reaction in thermal burn injuries in children. A prospective randomized and matched pairing study of 20 to 50% of TBSA was performed from children equal to both sexes affected by thermal injuries. The control group was included in normal children of both sexes. Serum malondialdehyde (MDA), total antioxidant capacity (TAC), total oxidant capacity (TOC), and glutathione (GSH) levels were analyzed and the results were analyzed statistically. In this study, it was found that PLM treatment increased TAC and GSH levels in burn patients significantly more than the other group. With the use of PLM, TOC decreased to normal level from day 3. In the HFAg group, TAC and GSH levels began to increase on the seventh day. On the first day of the burn, the TOC level started to increase. This increase continued on days 7 and 14. The TOC level began to fall on the 21st day. The increase in TAC was higher in the PLM group. In the PLM group, TOC fell faster. As a result, we think that different burn dressings can have different systemic effects. We can speculate that PLM has an antioxidant effect in the burn tissue due to high lactate content. Therefore, PLM may have decreased serum oxidative stress indicators more effectively than HFAg.",2019,"Serum malondialdehyde (MDA), total antioxidant capacity (TAC), total oxidant capacity (TOC), and glutathione (GSH) levels were analyzed and the results were analyzed statistically.","['Children with Partial Burn', 'thermal burn injuries in children']","['TBSA', 'hydrofiber dressing with silver (HFAg) and a polylactic membrane (PLM', 'PLM, TOC', 'Two Different Burn Dressings', 'PLM']","['TAC and GSH levels', 'serum oxidative stress indicators', 'TAC', 'TOC level', 'TOC fell faster', 'Serum malondialdehyde (MDA), total antioxidant capacity (TAC), total oxidant capacity (TOC), and glutathione (GSH) levels', 'Serum Oxidative Stress Indicators']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0701836', 'cui_str': 'Thermal burn (morphologic abnormality)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C4321376', 'cui_str': 'Dressing'}, {'cui': 'C0037125', 'cui_str': 'Silver'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}]","[{'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}]",,0.0193011,"Serum malondialdehyde (MDA), total antioxidant capacity (TAC), total oxidant capacity (TOC), and glutathione (GSH) levels were analyzed and the results were analyzed statistically.","[{'ForeName': 'Kubilay', 'Initials': 'K', 'LastName': 'Gürünlüoğlu', 'Affiliation': 'Pediatric Intensive Burn Care Unit, Department of Pediatric Surgery, İnönü University Faculty of Medicine, Malatya, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Demircan', 'Affiliation': 'Pediatric Intensive Burn Care Unit, Department of Pediatric Surgery, İnönü University Faculty of Medicine, Malatya, Turkey.'}, {'ForeName': 'Aytaç', 'Initials': 'A', 'LastName': 'Taşçı', 'Affiliation': 'Pediatric Intensive Burn Care Unit, Department of Pediatric Surgery, İnönü University Faculty of Medicine, Malatya, Turkey.'}, {'ForeName': 'Muhammed Mehdi', 'Initials': 'MM', 'LastName': 'Üremiş', 'Affiliation': 'Department of Medical Biochemistry, İnönü University Faculty of Medicine, Malatya, Turkey.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Türköz', 'Affiliation': 'Department of Medical Biochemistry, İnönü University Faculty of Medicine, Malatya, Turkey.'}, {'ForeName': 'Harika Gözükara', 'Initials': 'HG', 'LastName': 'Bağ', 'Affiliation': 'Department of Biostatistics and Medical Informatics, İnönü University Faculty of Medicine, Malatya, Turkey.'}, {'ForeName': 'Ayşehan', 'Initials': 'A', 'LastName': 'Akıncı', 'Affiliation': 'Department of Pediatric Endocrinology, İnönü University Faculty of Medicine, Malatya, Turkey.'}, {'ForeName': 'Ercan', 'Initials': 'E', 'LastName': 'Bayrakçı', 'Affiliation': 'Erzurum Regional Education and Research Hospital, Department of Pediatric Surgery, Erzurum, Turkey.'}]",Journal of burn care & research : official publication of the American Burn Association,['10.1093/jbcr/irz037']
229,32271182,Comparison of Adductor Canal Block and Femoral Triangle Block for Total Knee Arthroplasty.,"OBJECTIVES


Adductor canal block (ACB) could provide effective postoperative pain control for patients after total knee arthroplasty (TKA). However, some authors pointed out that the ACB as originally described may be more similar to a femoral triangle block (FTB). Recent neuroanatomic evidences made the authors conjecture that the ""true"" ACB would provide superior analgesia compared with FTB. Therefore, the study was designed to determine the hypothesis that postoperative analgesia after TKA could be improved by a ""true"" ACB compared with FTB.
MATERIALS AND METHODS


Patients undergoing unilateral, primary TKA were randomized into the ACB group or FTB group. The primary outcome was postoperative pain during active flexion at 8 hours after surgery measured by the visual analog scale (VAS). In addition, pain scores at other time points, quadriceps strength, morphine consumption, satisfaction of the patient, and side effects of morphine were also evaluated.
RESULTS


Sixty participants completed the research. The VAS scores were lower in the ACB group than the FTB group at 8 and 24 hours at rest (P<0.05). The VAS scores were lower in the ACB group than the FTB group at 4, 8, 24, and 48 hours during active flexion (P<0.05). The quadriceps strength was superior in the ACB group than the FTB group at 4, 8, and 24 hours (P<0.05). The consumption of morphine was lower in the ACB group than the FTB group (P<0.05). However, there were no significant differences for both patient satisfaction and the incidence of adverse reactions (P>0.05).
DISCUSSION


ACB can provide superior analgesia and preserve more quadriceps strength than FTB. ACB facilitates functional recovery in the early stages and is compatible with the highly recognized concept of rapid rehabilitation, which should be promoted in the clinic.",2020,"However, there were no significant differences for both patient satisfaction and incidence of adverse reaction (P>0.05).
","['Sixty subjects completed the research', 'Subjects undergoing unilateral, primary TKA', 'patients following total knee arthroplasty (TKA', 'Total Knee Arthroplasty']","['TKA', 'Adductor Canal Block and Femoral Triangle Block', 'Adductor canal block (ACB', 'FTB', 'ACB']","['consumption of morphine', 'quadriceps strength', 'postoperative pain during active flexion at 8 hours after surgery measured by visual analogue scale (VAS', 'quadriceps strength, morphine consumption, satisfactions of patient and side effects of morphine', 'pain scores', 'patient satisfaction and incidence of adverse reaction', 'VAS scores']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0225265', 'cui_str': 'Femoral triangle structure'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0224440', 'cui_str': 'Structure of quadriceps femoris muscle'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0422618,"However, there were no significant differences for both patient satisfaction and incidence of adverse reaction (P>0.05).
","[{'ForeName': 'Chun-Guang', 'Initials': 'CG', 'LastName': 'Wang', 'Affiliation': 'Departments of Anesthesiology.'}, {'ForeName': 'Yan-Ling', 'Initials': 'YL', 'LastName': 'Ding', 'Affiliation': 'Departments of Anesthesiology.'}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Wang', 'Affiliation': 'Medical Ultrasonics.'}, {'ForeName': 'Jia-Yun', 'Initials': 'JY', 'LastName': 'Liu', 'Affiliation': 'Departments of Anesthesiology.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Orthopedics, The First Center Hospital of Baoding, Baoding, Hebei, China.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000833']
230,32271183,"Efficacy and Safety of Single and Multiple Doses of a Fixed-dose Combination of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: Results From 2 Phase 3, Randomized, Parallel-group, Double-blind, Placebo-controlled Studies.","OBJECTIVES


A previous pilot study demonstrated that various fixed-dose combinations (FDCs) of ibuprofen (IBU) and acetaminophen (APAP) provided analgesic efficacy comparable to a higher dose of IBU, with the same safety profile. These studies further evaluated the chosen FDC IBU/APAP 250/500 mg formulation.
MATERIALS AND METHODS


Two phase 3 dental pain studies enrolled healthy young patients with ≥moderate pain after ≥3 third molar extractions who received single-dose FDC IBU/APAP 250/500 mg, IBU 250 mg, APAP 650 mg, or placebo evaluated over 12 hours (study 1) or multiple-dose FDC or placebo every 8 hours, evaluated over 48 hours (study 2). Time-weighted sum of pain intensity differences over 8 (SPID[11]0-8) and 24 (SPID[11]0-24) hours were primary outcomes, respectively. Time to meaningful pain relief and duration of pain relief were assessed; tolerability was evaluated by adverse events.
RESULTS


Five hundred sixty-eight patients were randomized in study 1; 123 in study 2. Study 1: SPID[11]0-8 favored FDC significantly over placebo, IBU, and APAP (P<0.001, P=0.008, and P<0.001, respectively); study 2: SPID[11]0-24 significantly favored FDC over placebo (P<0.001), with sustained efficacy during multiple dosing. Time to meaningful pain relief occurred within 1 hour; pain relief duration was >8 hours in both studies. Adverse event rates were lowest with the FDC.
DISCUSSION


FDC IBU/APAP 250/500 mg provides superior analgesic efficacy to individual monocomponents (IBU 250 mg and APAP 650 mg), a rapid onset of action, >8-hour duration of pain relief, is generally well tolerated, and may provide an additional nonopioid treatment option for acute pain.",2020,▒mg provides superior analgesic efficacy to individual monocomponents,"['568 patients were randomized in Study 1; 123 in Study 2', 'Two phase 3 dental pain studies enrolled healthy young patients with ≥moderate pain after ≥3 third molar extractions who received', 'Postsurgical Dental Pain']","['FDC over placebo', 'individual monocomponents', 'ibuprofen (IBU) and acetaminophen (APAP', 'Placebo', 'single-dose FDC IBU/APAP 250▒mg/500▒mg, IBU 250▒mg, APAP 650▒mg, or placebo', 'Ibuprofen and Acetaminophen', 'multiple-dose FDC or placebo']","['Time to meaningful pain relief (TMPR) and duration of pain relief', 'TMPR', 'analgesic efficacy', 'Time-weighted sum of pain intensity differences', 'pain relief duration', 'Efficacy and Safety', 'AE rates', 'FDC significantly over placebo, IBU, and APAP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0340427', 'cui_str': 'Primary familial dilated cardiomyopathy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0721022', 'cui_str': 'Ibu'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0340427', 'cui_str': 'Primary familial dilated cardiomyopathy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0721022', 'cui_str': 'Ibu'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]",568.0,0.336205,▒mg provides superior analgesic efficacy to individual monocomponents,"[{'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Searle', 'Affiliation': 'PRA Health Sciences.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Muse', 'Affiliation': 'Jean Brown Research Inc., Salt Lake City, UT.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Paluch', 'Affiliation': 'Independent Consultant.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Leyva', 'Affiliation': 'Pfizer Consumer Healthcare, Madison.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'DePadova', 'Affiliation': 'Pfizer Consumer Healthcare, Madison.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cruz-Rivera', 'Affiliation': 'Rx-to-OTC Switch, Sanofi Consumer Health Care, Bridgewater, NJ.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kellstein', 'Affiliation': 'Independent Consultant.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000828']
231,31564241,"A pragmatic, multi-centered, stepped wedge, cluster randomized controlled trial pilot of the clinical and cost effectiveness of a complex Stroke Oral healthCare intervention pLan Evaluation II (SOCLE II) compared with usual oral healthcare in stroke wards.","BACKGROUND


Patients with stroke-associated pneumonia experience poorer outcomes (increased hospital stays, costs, discharge dependency, and risk of death). High-quality, organized oral healthcare may reduce the incidence of stroke-associated pneumonia and improve oral health and quality of life.
AIMS


We piloted a pragmatic, stepped-wedge, cluster randomized controlled trial of clinical and cost effectiveness of enhanced versus usual oral healthcare for people in stroke rehabilitation settings.
METHODS


Scottish stroke rehabilitation wards were randomly allocated to stepped time-points for conversion from usual to enhanced oral healthcare. All admissions and nursing staff were eligible for inclusion. We piloted the viability of randomization, intervention, data collection, record linkage procedures, our sample size, screening, and recruitment estimates. The stepped-wedge trial design prevented full blinding of outcome assessors and staff. Predetermined criteria for progression included the validity of enhanced oral healthcare intervention (training, oral healthcare protocol, assessment, equipment), data collection, and stroke-associated pneumonia event rate and relationship between stroke-associated pneumonia and plaque.
RESULTS


We screened 1548/2613 (59%) admissions to four wards, recruiting  n  = 325 patients and  n  = 112 nurses. We observed marked between-site diversity in admissions, recruitment populations, stroke-associated pneumonia events (0% to 21%), training, and resource use. No adverse events were reported. Oral healthcare documentation was poor. We found no evidence of a difference in stroke-associated pneumonia between enhanced versus usual oral healthcare ( P  = 0.62, odds ratio = 0.61, confidence interval: 0.08 to 4.42).
CONCLUSIONS


Our stepped-wedge cluster randomized control trial accommodated between-site diversity. The stroke-associated pneumonia event rate did not meet our predetermined progression criteria. We did not meet our predefined progression criteria including the SAP event rate and consequently were unable to establish whether there is a relationship between SAP and plaque. A wide confidence interval did not exclude the possibility that enhanced oral healthcare may result in a benefit or detrimental effect.
TRIAL REGISTRATION


NCT01954212.",2020,"We found no evidence of a difference in stroke-associated pneumonia between enhanced versus usual oral healthcare ( P  = 0.62, odds ratio = 0.61, confidence interval: 0.08 to 4.42).
","['We screened 1548/2613 (59%) admissions to four wards, recruiting  n \u2009=\u2009325 patients and  n \u2009=\u2009112 nurses', 'Scottish stroke rehabilitation wards', 'stroke wards']","['complex Stroke Oral healthCare intervention pLan Evaluation II (SOCLE II', 'enhanced versus usual oral healthcare', 'stepped time-points for conversion from usual to enhanced oral healthcare']","['hospital stays, costs, discharge dependency, and risk of death', 'adverse events', 'stroke-associated pneumonia', 'oral health and quality of life', 'stroke-associated pneumonia event rate']","[{'cui': 'C4517714', 'cui_str': 'Three hundred and twenty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0204097', 'cui_str': 'Stroke Rehabilitation'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0029162'}, {'cui': 'C0034380'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",325.0,0.182854,"We found no evidence of a difference in stroke-associated pneumonia between enhanced versus usual oral healthcare ( P  = 0.62, odds ratio = 0.61, confidence interval: 0.08 to 4.42).
","[{'ForeName': 'Marian C', 'Initials': 'MC', 'LastName': 'Brady', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stott', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Weir', 'Affiliation': 'Centre for Population Health Sciences, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Campbell', 'Initials': 'C', 'LastName': 'Chalmers', 'Affiliation': 'Royal National Institute of Blind People, Glasgow, UK.'}, {'ForeName': 'Petrina', 'Initials': 'P', 'LastName': 'Sweeney', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Barr', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Pollock', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Bowers', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gray', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Brenda Jean', 'Initials': 'BJ', 'LastName': 'Bain', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Collins', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Keerie', 'Affiliation': 'The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Langhorne', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493019871824']
232,31263231,Reaching measures and feedback effects in auditory peripersonal space.,"We analyse the effects of exploration feedback on reaching measures of perceived auditory peripersonal space (APS) boundary and the auditory distance perception (ADP) of sound sources located within it. We conducted an experiment in which the participants had to estimate if a sound source was (or not) reachable and to estimate its distance (40 to 150 cm in 5-cm steps) by reaching to a small loudspeaker. The stimulus consisted of a train of three bursts of Gaussian broadband noise. Participants were randomly assigned to two groups: Experimental (EG) and Control (CG). There were three phases in the following order: Pretest-Test-Posttest. For all phases, the listeners performed the same task except for the EG-Test phase where the participants reach in order to touch the sound source. We applied models to characterise the participants' responses and provide evidence that feedback significantly reduces the response bias of both the perceived boundary of the APS and the ADP of sound sources located within reach. In the CG, the repetition of the task did not affect APS and ADP accuracy, but it improved the performance consistency: the reachable uncertainty zone in APS was reduced and there was a tendency to decrease variability in ADP.",2019,"In the CG, the repetition of the task did not affect APS and ADP accuracy, but it improved the performance consistency: the reachable uncertainty zone in APS was reduced and there was a tendency to decrease variability in ADP.",['participants had to estimate if a sound source was (or not) reachable and to estimate its distance (40 to 150\u2009cm in 5-cm steps) by reaching to a small loudspeaker'],['exploration feedback'],"['APS and ADP accuracy', 'auditory peripersonal space (APS) boundary\xa0and the auditory distance perception (ADP']","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C3879138', 'cui_str': 'Loudspeaker (physical object)'}]","[{'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0031207', 'cui_str': 'Peripersonal Space'}, {'cui': 'C0012752', 'cui_str': 'Distance Perception'}]",,0.0218906,"In the CG, the repetition of the task did not affect APS and ADP accuracy, but it improved the performance consistency: the reachable uncertainty zone in APS was reduced and there was a tendency to decrease variability in ADP.","[{'ForeName': 'Mercedes X', 'Initials': 'MX', 'LastName': 'Hüg', 'Affiliation': 'Centro de Investigación y Transferencia en Acústica (CINTRA), Universidad Tecnológica Nacional - Facultad Regional Córdoba, CONICET, 5000, Córdoba, Argentina. mercehug@unc.edu.ar.'}, {'ForeName': 'Ramiro O', 'Initials': 'RO', 'LastName': 'Vergara', 'Affiliation': 'Consejo Nacional de Investigaciones Científicas y Tecnológicas (CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Fabián C', 'Initials': 'FC', 'LastName': 'Tommasini', 'Affiliation': 'Centro de Investigación y Transferencia en Acústica (CINTRA), Universidad Tecnológica Nacional - Facultad Regional Córdoba, CONICET, 5000, Córdoba, Argentina.'}, {'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Etchemendy', 'Affiliation': 'Consejo Nacional de Investigaciones Científicas y Tecnológicas (CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Bermejo', 'Affiliation': 'Centro de Investigación y Transferencia en Acústica (CINTRA), Universidad Tecnológica Nacional - Facultad Regional Córdoba, CONICET, 5000, Córdoba, Argentina.'}, {'ForeName': 'Laura G', 'Initials': 'LG', 'LastName': 'Fernandez', 'Affiliation': 'Centro de Investigación y Transferencia en Acústica (CINTRA), Universidad Tecnológica Nacional - Facultad Regional Córdoba, CONICET, 5000, Córdoba, Argentina.'}]",Scientific reports,['10.1038/s41598-019-45755-2']
233,32277364,"Phase I, First-in-Human, Single and Multiple Ascending Dose- and Food-Effect Studies to Assess the Safety, Tolerability and Pharmacokinetics of a Novel Anti-hepatitis B Virus Drug, Bentysrepinine (Y101), in Healthy Chinese Subjects.","BACKGROUND AND OBJECTIVE


Bentysrepinine (Y101), a derivative of repensine (a compound isolated from Dichondra repens Forst), is a novel phenylalanine dipeptide currently under development for the treatment of hepatitis B virus (HBV). The objectives of these studies were to assess the safety, tolerability and pharmacokinetics of bentysrepinine in healthy Chinese subjects.
METHODS


Two randomised, double-blind, placebo-controlled trials evaluated a single oral dose (50-900 mg, study 01) and multiple doses (300 mg and 600 mg, study 02), and a randomised, open, crossover food-effect study (600 mg, study 03) of bentysrepinine was established. Safety and tolerability were assessed by adverse event (AE) reporting, clinical laboratory tests, physical examinations, vital sign monitoring and electrocardiogram (ECG). Plasma, urine and faecal samples were analysed using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods to investigate the pharmacokinetics of bentysrepinine.
RESULTS


Ninety-four subjects were enrolled, and bentysrepinine was well tolerated. Mild and reversible AEs occurred for single and multiple oral doses between 50 and 900 mg. The most common adverse effects were increased alanine aminotransferase (ALT) and aspartate transaminase (AST). Other clinically significant AEs included nausea and elevated urine leukocytes, urine red blood cells, transaminase, creatine kinase, total cholesterol, triglycerides, and low-density cholesterol. There were no clinically significant changes in the ECG, vital signs or laboratory assessments during the studies. The maximum tolerated dose (MTD) was not reached in the dose escalation study. Bentysrepinine was rapidly absorbed and metabolised with a mean time to reach maximum concentration (T max ) between 1-2 h and a mean terminal elimination half-life (t 1/2 ) of approximately 1-3 h. In the single ascending dose study, the exposure including the area under the concentration-time curve (AUC) and the maximum plasma concentration (C max ) of bentysrepinine generally increased in a dose-dependent but not dose-proportional manner in the 50-900 mg dose range. The urinary excretion and faecal excretion of unchanged bentysrepinine were 2.98% and 4.58% of the total dose, respectively. In the multiple-dose study, no accumulation was found after repeated administration at the 300 mg and 600 mg dose levels. The food-effect study using a 600 mg single dose showed that food intake has an obvious effect on the absorption of bentysrepinine from tablets. No experimental differences were found based on sex.
CONCLUSION


Bentysrepinine exhibited acceptable safety and tolerability in healthy subjects in the dose range of 50-900 mg in both single- and multiple-dose studies. The drug did not exhibit linear pharmacokinetic characteristics. No accumulation was observed after the administration of multiple 300 and 600 mg doses. Bentysrepinine is extensively metabolised in the body. Food may increase its bioavailability.
TRIALS REGISTRATION


CFDA registration numbers CTR20160096, CTR20160094, and CTR20140543 (www.chinadrugtrials.org.cn).",2020,Bentysrepinine was rapidly absorbed and metabolised with a mean time to reach maximum concentration (T max ) between 1-2 h and a mean terminal elimination half-life (t 1/2 ) of approximately 1-3 h.,"['healthy Chinese subjects', 'healthy subjects', 'Ninety-four subjects were enrolled, and', 'Healthy Chinese Subjects']","['bentysrepinine', 'Bentysrepinine', 'Novel Anti-hepatitis B Virus Drug, Bentysrepinine', 'placebo']","['bioavailability', 'safety, tolerability and pharmacokinetics', 'Safety, Tolerability and Pharmacokinetics', 'tolerated', 'maximum tolerated dose (MTD', 'Safety and tolerability', 'urinary excretion and faecal excretion of unchanged bentysrepinine', 'ECG, vital signs or laboratory assessments', 'concentration-time curve (AUC) and the maximum plasma concentration (C max ) of bentysrepinine', 'Plasma, urine and faecal samples', 'acceptable safety and tolerability', 'nausea and elevated urine leukocytes, urine red blood cells, transaminase, creatine kinase, total cholesterol, triglycerides, and low-density cholesterol', 'adverse event (AE) reporting, clinical laboratory tests, physical examinations, vital sign monitoring and electrocardiogram (ECG', 'Mild and reversible AEs', 'alanine aminotransferase (ALT) and aspartate transaminase (AST']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C3493298', 'cui_str': 'N-(N-benzoyl-O-(2-dimethylaminoethyl)-L-tyrosyl)-L-phenylalaninol'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0442739', 'cui_str': 'No status change'}, {'cui': 'C3493298', 'cui_str': 'N-(N-benzoyl-O-(2-dimethylaminoethyl)-L-tyrosyl)-L-phenylalaninol'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0555120', 'cui_str': 'Urine micr.:leukocytes present'}, {'cui': 'C0427827', 'cui_str': 'Urine: red - blood'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}]",94.0,0.106305,Bentysrepinine was rapidly absorbed and metabolised with a mean time to reach maximum concentration (T max ) between 1-2 h and a mean terminal elimination half-life (t 1/2 ) of approximately 1-3 h.,"[{'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Xue', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'Department of Pharmaceutics, College of Pharmaceutical Science, Soochow University, Suzhou, China.'}, {'ForeName': 'Shichao', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmaceutics, College of Pharmaceutical Science, Soochow University, Suzhou, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Linsheng', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Qian', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': 'Bailing Enterprise Group Pharmaceutical Co., Ltd., Guizhou, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Jiang', 'Affiliation': 'Bailing Enterprise Group Pharmaceutical Co., Ltd., Guizhou, China.'}, {'ForeName': 'Chenrong', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China. chrishuangcr@163.com.'}, {'ForeName': 'Liyan', 'Initials': 'L', 'LastName': 'Miao', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China. miaoliyan@suda.edu.cn.'}]",Clinical drug investigation,['10.1007/s40261-020-00909-3']
234,32118297,Developing compassion and emotional intelligence in nursing students: A quasi-experimental study.,"PURPOSE


This study examined the effect of the Caring Behavior in Nursing course on the compassion and emotional intelligence levels of nursing students.
DESIGN AND METHODS


This quasi-experimental study was carried out using pretest and posttest design. The research sample consisted of the intervention (n = 37) and the control (n = 36) group. Data were collected through ""The Emotional Intelligence Evaluation Survey"" and ""The Compassion Scale.""
FINDINGS


It was determined that the compassion levels of the students in the intervention group were statistically significantly higher than the compassion levels of the control group of students.
PRACTICE IMPLICATIONS


It was found that the Caring Behavior in Nursing course was effective in developing compassion.",2020,"FINDINGS


It was determined that the compassion levels of the students in the intervention group were statistically significantly higher than the compassion levels of the control group of students.
",['nursing students'],[],"['Emotional Intelligence Evaluation Survey"" and ""The Compassion Scale', 'compassion and emotional intelligence levels', 'compassion levels', 'Developing compassion and emotional intelligence']","[{'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}]",[],"[{'cui': 'C1510539', 'cui_str': 'Emotional Intelligences'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0222045'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0170807,"FINDINGS


It was determined that the compassion levels of the students in the intervention group were statistically significantly higher than the compassion levels of the control group of students.
","[{'ForeName': 'Gamze', 'Initials': 'G', 'LastName': 'Teskereci', 'Affiliation': 'Department of Obstetric and Gynecologic Nursing, Akdeniz University Kumluca Health Science Faculty, Antalya, Turkey.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Öncel', 'Affiliation': 'Department of Public Health Nursing, Akdeniz University Nursing Faculty, Antalya, Turkey.'}, {'ForeName': 'Ülkü', 'Initials': 'Ü', 'LastName': 'Özer Arslan', 'Affiliation': 'Fundamentals of Nursing Department, Akdeniz University Kumluca Health Science Faculty, Antalya, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12494']
235,32078683,Effect of Intravenous Tenecteplase Dose on Cerebral Reperfusion Before Thrombectomy in Patients With Large Vessel Occlusion Ischemic Stroke: The EXTEND-IA TNK Part 2 Randomized Clinical Trial.,"Importance


Intravenous thrombolysis with tenecteplase improves reperfusion prior to endovascular thrombectomy for ischemic stroke compared with alteplase.
Objective


To determine whether 0.40 mg/kg of tenecteplase safely improves reperfusion before endovascular thrombectomy vs 0.25 mg/kg of tenecteplase in patients with large vessel occlusion ischemic stroke.
Design, Setting, and Participants


Randomized clinical trial at 27 hospitals in Australia and 1 in New Zealand using open-label treatment and blinded assessment of radiological and clinical outcomes. Patients were enrolled from December 2017 to July 2019 with follow-up until October 2019. Adult patients (N = 300) with ischemic stroke due to occlusion of the intracranial internal carotid, \basilar, or middle cerebral artery were included less than 4.5 hours after symptom onset using standard intravenous thrombolysis eligibility criteria.
Interventions


Open-label tenecteplase at 0.40 mg/kg (maximum, 40 mg; n = 150) or 0.25 mg/kg (maximum, 25 mg; n = 150) given as a bolus before endovascular thrombectomy.
Main Outcomes and Measures


The primary outcome was reperfusion of greater than 50% of the involved ischemic territory prior to thrombectomy, assessed by consensus of 2 blinded neuroradiologists. Prespecified secondary outcomes were level of disability at day 90 (modified Rankin Scale [mRS] score; range, 0-6); mRS score of 0 to 1 (freedom from disability) or no change from baseline at 90 days; mRS score of 0 to 2 (functional independence) or no change from baseline at 90 days; substantial neurological improvement at 3 days; symptomatic intracranial hemorrhage within 36 hours; and all-cause death.
Results


All 300 patients who were randomized (mean age, 72.7 years; 141 [47%] women) completed the trial. The number of participants with greater than 50% reperfusion of the previously occluded vascular territory was 29 of 150 (19.3%) in the 0.40 mg/kg group vs 29 of 150 (19.3%) in the 0.25 mg/kg group (unadjusted risk difference, 0.0% [95% CI, -8.9% to -8.9%]; adjusted risk ratio, 1.03 [95% CI, 0.66-1.61]; P = .89). Among the 6 secondary outcomes, there were no significant differences in any of the 4 functional outcomes between the 0.40 mg/kg and 0.25 mg/kg groups nor in all-cause deaths (26 [17%] vs 22 [15%]; unadjusted risk difference, 2.7% [95% CI, -5.6% to 11.0%]) or symptomatic intracranial hemorrhage (7 [4.7%] vs 2 [1.3%]; unadjusted risk difference, 3.3% [95% CI, -0.5% to 7.2%]).
Conclusions and Relevance


Among patients with large vessel occlusion ischemic stroke, a dose of 0.40 mg/kg, compared with 0.25 mg/kg, of tenecteplase did not significantly improve cerebral reperfusion prior to endovascular thrombectomy. The findings suggest that the 0.40-mg/kg dose of tenecteplase does not confer an advantage over the 0.25-mg/kg dose in patients with large vessel occlusion ischemic stroke in whom endovascular thrombectomy is planned.
Trial Registration


ClinicalTrials.gov Identifier: NCT03340493.",2020,"Among the 6 secondary outcomes, there were no significant differences in any of the 4 functional outcomes between the 0.40 mg/kg and 0.25 mg/kg groups nor in all-cause deaths (26 [17%] vs 22 [15%]; unadjusted risk difference, 2.7% [95% CI, -5.6% to 11.0%]) or symptomatic intracranial hemorrhage (7 [4.7%] vs 2 [1.3%]; unadjusted risk difference, 3.3% [95% CI, -0.5% to 7.2%]).
","['Adult patients (N\u2009=\u2009300) with ischemic stroke due to occlusion of the intracranial internal carotid, \\basilar, or middle cerebral artery were included less than 4.5 hours after symptom onset using standard intravenous thrombolysis eligibility criteria', 'All 300 patients who were randomized (mean age, 72.7 years; 141 [47%] women) completed the trial', 'Patients With Large Vessel Occlusion Ischemic Stroke', 'Patients were enrolled from December 2017 to July 2019 with follow-up until October 2019', '27 hospitals in Australia and 1 in New Zealand using open-label treatment and blinded assessment of radiological and clinical outcomes', 'patients with large vessel occlusion ischemic stroke']","['Interventions\n\n\nOpen-label tenecteplase at 0.40 mg/kg (maximum, 40 mg; n\u2009=\u2009150) or 0.25 mg/kg']","['Cerebral Reperfusion', 'occluded vascular territory', 'cause deaths', 'symptomatic intracranial hemorrhage', 'cerebral reperfusion', '4 functional outcomes', 'reperfusion of greater than 50% of the involved ischemic territory prior to thrombectomy', 'level of disability at day 90 (modified Rankin Scale [mRS] score; range, 0-6); mRS score of 0 to 1 (freedom from disability) or no change from baseline at 90 days; mRS score of 0 to 2 (functional independence) or no change from baseline at 90 days; substantial neurological improvement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0225990', 'cui_str': 'Large vessel'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}]","[{'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",,0.594367,"Among the 6 secondary outcomes, there were no significant differences in any of the 4 functional outcomes between the 0.40 mg/kg and 0.25 mg/kg groups nor in all-cause deaths (26 [17%] vs 22 [15%]; unadjusted risk difference, 2.7% [95% CI, -5.6% to 11.0%]) or symptomatic intracranial hemorrhage (7 [4.7%] vs 2 [1.3%]; unadjusted risk difference, 3.3% [95% CI, -0.5% to 7.2%]).
","[{'ForeName': 'Bruce C V', 'Initials': 'BCV', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Mitchell', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Nawaf', 'Initials': 'N', 'LastName': 'Yassi', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Kleinig', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Dowling', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Bush', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Thijs', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Scroop', 'Affiliation': 'Department of Radiology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Simpson', 'Affiliation': 'Department of Neurology, Austin Hospital, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brooks', 'Affiliation': 'Department of Radiology, Austin Hospital, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Asadi', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Teddy Y', 'Initials': 'TY', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Darshan G', 'Initials': 'DG', 'LastName': 'Shah', 'Affiliation': 'Department of Neurology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Tissa', 'Initials': 'T', 'LastName': 'Wijeratne', 'Affiliation': 'Melbourne Medical School, Department of Medicine and Neurology, The University of Melbourne and Western Health, Sunshine Hospital, St Albans Victoria, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Fana', 'Initials': 'F', 'LastName': 'Alemseged', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Ng', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bailey', 'Affiliation': 'Department of Neurology, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Rice', 'Affiliation': 'Department of Radiology, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'de Villiers', 'Affiliation': 'Department of Radiology, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Dewey', 'Affiliation': 'Eastern Health and Eastern Health Clinical School, Department of Neurosciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Philip M C', 'Initials': 'PMC', 'LastName': 'Choi', 'Affiliation': 'Eastern Health and Eastern Health Clinical School, Department of Neurosciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Department of Neurology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Kendal', 'Initials': 'K', 'LastName': 'Redmond', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leggett', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Fink', 'Affiliation': 'Department of Neurology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Collecutt', 'Affiliation': 'Department of Radiology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kraemer', 'Affiliation': 'Department of Medicine, Ballarat Base Hospital, Ballarat, Victoria, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Krause', 'Affiliation': 'Department of Neurology, Royal North Shore Hospital and Kolling Institute, University of Sydney, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Cordato', 'Affiliation': 'Department of Neurology, Liverpool Hospital, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Field', 'Affiliation': 'Department of Neurology, Lyell McEwin Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'School of Clinical Sciences, Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Neurology, Gosford Hospital, Gosford, New South Wales, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Clissold', 'Affiliation': 'Department of Neurology, University Hospital Geelong, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Miteff', 'Affiliation': 'Department of Neurology, Priority Research Centre for Brain and Mental Health Research, John Hunter Hospital, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Clissold', 'Affiliation': 'Department of Medicine, Southwest Healthcare, Warrnambool, Victoria, Australia.'}, {'ForeName': 'Geoffrey C', 'Initials': 'GC', 'LastName': 'Cloud', 'Affiliation': 'Department of Neurology, Alfred Hospital, Prahran, Victoria, Australia.'}, {'ForeName': 'Leslie E', 'Initials': 'LE', 'LastName': 'Bolitho', 'Affiliation': 'Department of Medicine, Northeast Health, Wangaratta, Victoria, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Bonavia', 'Affiliation': 'Department of Medicine, Albury Base Hospital, Albury, New South Wales, Australia.'}, {'ForeName': 'Arup', 'Initials': 'A', 'LastName': 'Bhattacharya', 'Affiliation': 'Department of Medicine, Goulburn Valley Health, Shepparton, Victoria, Australia.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Wright', 'Affiliation': 'Department of Medicine, Latrobe Regional Health, Traralgon, Victoria, Australia.'}, {'ForeName': 'Abul', 'Initials': 'A', 'LastName': 'Mamun', 'Affiliation': 'Department of Medicine, Campbelltown Hospital, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Fintan', 'Initials': 'F', 'LastName': ""O'Rourke"", 'Affiliation': 'Department of Aged Care and Rehabilitation, Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Worthington', 'Affiliation': 'Department of Neurology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Wong', 'Affiliation': ""Department of Neurology, Royal Brisbane and Women's Hospital and the University of Queensland, Brisbane, Queensland, Australia.""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Levi', 'Affiliation': 'Maridulu budyari gumal, The Sydney Partnership for Health Education Research & Enterprise (SPHERE), University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Christopher F', 'Initials': 'CF', 'LastName': 'Bladin', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Desmond', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.1511']
236,31189978,"Randomized Evaluation of Anagliptin vs Sitagliptin On low-density lipoproteiN cholesterol in diabetes (REASON) Trial: A 52-week, open-label, randomized clinical trial.","Additional reductions in low-density lipoprotein-cholesterol (LDL-C) via antidiabetic therapies should be considered in statin-using patients with sub-optimal LDL-C levels. We compared the efficacy of anagliptin and sitagliptin, two antidiabetic therapies, in reducing LDL-C in type 2 diabetic patients. A randomized, open-label, parallel-group trial was conducted at 17 centres in Japan between April 2015 and January 2018. Adults (age ≥20 years) with type 2 diabetes, any atherosclerotic vascular lesions, and statin prescriptions were included. Anagliptin or sitagliptin were administered for 52 weeks. Primary and secondary endpoints were changes in LDL-C and haemoglobin A1C (HbA1c) levels, respectively. We assessed the superiority (primary endpoint) and non-inferiority (secondary endpoint) of anagliptin over sitagliptin. This study was registered at Clinicaltrials.gov (NCT02330406). Of 380 participants, 353 were eligible and randomized. Mean participant age was 68 years, and 61% were males. Baseline median LDL-C and HbA1c were 108 mg/dL and 6.9%, respectively. Changes in LDL-C were -3.7 mg/dL with anagliptin and +2.1 mg/dL with sitagliptin at 52 weeks, and the estimated treatment difference was a significant -4.5 mg/dL (P = 0.01 for superiority). Changes in HbA1c were +0.02% with anagliptin and +0.12% with sitagliptin (P < 0.0001 for non-inferiority). Overall, anagliptin was superior to sitagliptin in lowering LDL-C without deteriorating HbA1c.",2019,"Overall, anagliptin was superior to sitagliptin in lowering LDL-C without deteriorating HbA1c.","['17 centres in Japan between April 2015 and January 2018', 'type 2 diabetic patients', 'low-density lipoproteiN cholesterol in diabetes (REASON', 'Adults (age ≥20 years) with type 2 diabetes, any atherosclerotic vascular lesions, and statin prescriptions were included', 'Mean participant age was 68 years, and 61% were males', '380 participants, 353 were eligible and randomized']","['Anagliptin vs Sitagliptin', 'Anagliptin or sitagliptin', 'anagliptin and sitagliptin, two antidiabetic therapies']","['low-density lipoprotein-cholesterol (LDL-C', 'changes in LDL-C and haemoglobin A1C (HbA1c) levels', 'Baseline median LDL-C and HbA1c', 'LDL-C', 'Changes in HbA1c']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}]","[{'cui': 'C3272640', 'cui_str': 'Pyrazolo(1,5-a)pyrimidine-6-carboxamide, N-(2-((2-((2S)-2-cyano-1-pyrrolidinyl)-2-oxoethyl)amino)-2-methylpropyl)-2-methyl-'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",,0.230143,"Overall, anagliptin was superior to sitagliptin in lowering LDL-C without deteriorating HbA1c.","[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, 1-1 Mukogawa, Nishinomiya, Hyogo, 663-8501, Japan. t-morimoto@umin.net.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Sakuma', 'Affiliation': 'Caress Sapporo Hokko Memorial Clinic N-27, E-8, 1-15, Higashi, Sapporo, Hokkaido, 065-0027, Japan.'}, {'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Sakuma', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, 1-1 Mukogawa, Nishinomiya, Hyogo, 663-8501, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Tokushige', 'Affiliation': 'Department of Pharmacology and Therapeutics, University of the Ryukyus, 207 Uehara, Nishihara, Okinawa, 903-0215, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Natsuaki', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, 5-1-1 Nabeshima, Saga, 849-8501, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Asahi', 'Affiliation': 'Department of Cardiology, Naha City Hospital, 2-31-1 Furujima, Naha, Okinawa, 902-8511, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Shimabukuro', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism, Fukushima Medical University, 1 Hikarigaoka, Fukushima, 960-1295, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nomiyama', 'Affiliation': 'Department of Endocrinology and Diabetes Mellitus, Fukuoka University, 7-45-1 Nanakuma, Jyonan, Fukuoka, 814-0180, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Arasaki', 'Affiliation': 'Department of Cardiology, Tomishiro Central Hospital, 25 Ueda, Tomigusuku, Okinawa, 901-0243, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, 5-1-1 Nabeshima, Saga, 849-8501, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Ueda', 'Affiliation': 'Department of Pharmacology and Therapeutics, University of the Ryukyus, 207 Uehara, Nishihara, Okinawa, 903-0215, Japan.'}]",Scientific reports,['10.1038/s41598-019-44885-x']
237,31474193,Endovascular versus medical therapy for large-vessel anterior occlusive stroke presenting with mild symptoms.,"BACKGROUND


Acute ischemic stroke patients with a large-vessel occlusion but mild symptoms (NIHSS ≤ 6) pose a treatment dilemma between medical management and endovascular thrombectomy.
AIMS


To evaluate the differences in clinical outcomes of endovascular thrombectomy-eligible patients with target-mismatch perfusion profiles who undergo either medical management or endovascular thrombectomy.
METHODS


Forty-seven patients with acute ischemic stroke due to large-vessel occlusion, NIHSS ≤ 6, and a target-mismatch perfusion imaging profile were included. Patients underwent medical management or endovascular thrombectomy following treating neurointerventionalist and neurologist consensus. The primary outcome measure was NIHSS shift. Secondary outcome measures were symptomatic intracranial hemorrhage, in-hospital mortality, and 90-day mRS scores. The primary intention-to-treat and as-treated analyses were compared to determine the impact of crossover patient allocation on study outcome measures.
RESULTS


Forty-seven patients were included. Thirty underwent medical management (64%) and 17 underwent endovascular thrombectomy (36%). Three medical management patients underwent endovascular thrombectomy due to early clinical deterioration. Presentation NIHSS ( P  = 0.82), NIHSS shift ( P  = 0.62), and 90-day functional independence (mRS 0-2;  P  = 0.25) were similar between groups. Endovascular thrombectomy patients demonstrated an increased overall rate of intracranial hemorrhage (35.3% vs. 10.0%;  P  = 0.04), but symptomatic intracranial hemorrhage was similar between groups ( P  = 0.25). In-hospital mortality was similar between groups ( P  = 0.46), though all two deaths in the medical management group occurred among crossover patients. Endovascular thrombectomy patients demonstrated a longer length of stay (7.6 ± 7.2 vs. 4.3 ± 3.9 days;  P  = 0.04) and a higher frequency of unfavorable discharge to a skilled-nursing facility ( P  = 0.03) rather than home ( P  = 0.05).
CONCLUSIONS


Endovascular thrombectomy may pose an unfavorable risk-benefit profile over medical management for endovascular thrombectomy-eligible acute ischemic stroke patients with mild symptoms, which warrants a randomized trial in this subpopulation.",2020,"Endovascular thrombectomy patients demonstrated an increased overall rate of intracranial hemorrhage (35.3% vs. 10.0%;  P  = 0.04), but symptomatic intracranial hemorrhage was similar between groups ( P  = 0.25).","['endovascular thrombectomy-eligible acute ischemic stroke patients with mild symptoms', 'eligible patients with target-mismatch perfusion profiles who undergo either medical management or endovascular thrombectomy', 'Acute ischemic stroke patients with a large-vessel occlusion but mild symptoms (NIHSS\u2009≤\u20096', 'Forty-seven patients with acute ischemic stroke due to large-vessel occlusion, NIHSS\u2009≤\u20096, and a target-mismatch perfusion imaging profile were included', 'Forty-seven patients were included', 'large-vessel anterior occlusive stroke presenting with mild symptoms']","['Endovascular versus medical therapy', 'medical management or endovascular thrombectomy', 'endovascular thrombectomy']","['longer length of stay', 'NIHSS shift', '90-day functional independence', 'symptomatic intracranial hemorrhage, in-hospital mortality, and 90-day mRS scores', 'symptomatic intracranial hemorrhage', 'unfavorable discharge to a skilled-nursing facility', 'hospital mortality', 'overall rate of intracranial hemorrhage']","[{'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0225990', 'cui_str': 'Large vessel'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C2350393', 'cui_str': 'Perfusion Imaging'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C1298680', 'cui_str': 'Occlusive stroke'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0037265', 'cui_str': 'Extended Care Facilities'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",47.0,0.0909358,"Endovascular thrombectomy patients demonstrated an increased overall rate of intracranial hemorrhage (35.3% vs. 10.0%;  P  = 0.04), but symptomatic intracranial hemorrhage was similar between groups ( P  = 0.25).","[{'ForeName': 'Dylan N', 'Initials': 'DN', 'LastName': 'Wolman', 'Affiliation': 'Stanford Health Care, Department of Neuroimaging and Neurointervention, Stanford, CA, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Marcellus', 'Affiliation': 'Stanford Health Care, Department of Neuroimaging and Neurointervention, Stanford, CA, USA.'}, {'ForeName': 'Maarten G', 'Initials': 'MG', 'LastName': 'Lansberg', 'Affiliation': 'Stanford Health Care, Stanford Stroke Center, Stanford, CA, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Albers', 'Affiliation': 'Stanford Health Care, Stanford Stroke Center, Stanford, CA, USA.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Guenego', 'Affiliation': 'Stanford Health Care, Department of Neuroimaging and Neurointervention, Stanford, CA, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Marks', 'Affiliation': 'Stanford Health Care, Department of Neuroimaging and Neurointervention, Stanford, CA, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Dodd', 'Affiliation': 'Stanford Healthcare, Department of Neurosurgery, Stanford, CA, USA.'}, {'ForeName': 'Huy M', 'Initials': 'HM', 'LastName': 'Do', 'Affiliation': 'Stanford Health Care, Department of Neuroimaging and Neurointervention, Stanford, CA, USA.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Wintermark', 'Affiliation': 'Stanford Health Care, Department of Neuroimaging and Neurointervention, Stanford, CA, USA.'}, {'ForeName': 'Blake W', 'Initials': 'BW', 'LastName': 'Martin', 'Affiliation': 'Stanford Health Care, Department of Neuroimaging and Neurointervention, Stanford, CA, USA.'}, {'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Heit', 'Affiliation': 'Stanford Health Care, Department of Neuroimaging and Neurointervention, Stanford, CA, USA.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493019873510']
238,31676515,Comparative Evaluation of Chest Tube Insertion Site Dressings: A Randomized Controlled Trial.,"BACKGROUND


Little empirical evidence is available to guide decisions on what type of dressing to use and how often to change the dressing after placement of a thoracostomy tube.
OBJECTIVES


This prospective randomized controlled study was conducted to compare various dressing types and procedures after placement of thoracic and mediastinal chest tubes. Outcome measures included length of time between dressing changes, skin integrity, air leak presence, and patient-reported pain.
METHODS


The study involved a convenience sample of 127 patients with 236 chest tubes from 3 intensive care units at a midwestern regional medical center. The patients were randomized to 1 of 3 groups: (1) gauze and tape dressing changed once daily, (2) gauze and tape dressing changed every 3 days, and (3) silicone foam dressing changed every 3 days.
RESULTS


Patients with silicone foam dressings reported less pain at the insertion site than did patients with standard gauze and tape dressings, and patients with daily dressing changes reported significantly more pain with dressing removal than did patients with dressing changes every 3 days. The silicone foam dressing was associated with better skin integrity than the gauze and tape dressing. Dressing intactness, number of days with a chest tube inserted, and patient demographic characteristics did not differ significantly among the 3 groups.
CONCLUSIONS


Overall, the best type of dressing for promoting skin integrity and patient comfort was the silicone foam dressing. The results of this study may help identify best practices for dressing type and procedures among patients with chest tubes.",2019,"RESULTS


Patients with silicone foam dressings reported less pain at the insertion site than did patients with standard gauze and tape dressings, and patients with daily dressing changes reported significantly more pain with dressing removal than did patients with dressing changes every 3 days.","['127 patients with 236 chest tubes from 3 intensive care units at a midwestern regional medical center', 'patients with chest tubes']","['Chest Tube Insertion Site Dressings', 'thoracic and mediastinal chest tubes', 'gauze and tape dressing changed once daily, (2) gauze and tape dressing changed every 3 days, and (3) silicone foam dressing changed every 3 days']","['pain with dressing removal', 'pain', 'length of time between dressing changes, skin integrity, air leak presence, and patient-reported pain', 'Dressing intactness, number of days with a chest tube inserted, and patient demographic characteristics', 'skin integrity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0189476', 'cui_str': 'Tube thoracostomy'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0025066', 'cui_str': 'Mediastinum'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0590323', 'cui_str': 'Gauzes (physical object)'}, {'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1275551', 'cui_str': 'q3day'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C3164124', 'cui_str': 'Foam dressing'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4321376', 'cui_str': 'Dressing'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0085671', 'cui_str': 'Dressing change'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",127.0,0.0577492,"RESULTS


Patients with silicone foam dressings reported less pain at the insertion site than did patients with standard gauze and tape dressings, and patients with daily dressing changes reported significantly more pain with dressing removal than did patients with dressing changes every 3 days.","[{'ForeName': 'Michelle D', 'Initials': 'MD', 'LastName': 'Wood', 'Affiliation': 'Michelle D. Wood is a clinical nurse specialist for Parkview Heart Institute, Jan Powers is director of nursing research and professional practice, and Jennifer L. Rechter is clinical nurse specialist for the medical intensive care unit, Parkview Health, Fort Wayne, Indiana. michelle.wood@parkview.com.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Powers', 'Affiliation': 'Michelle D. Wood is a clinical nurse specialist for Parkview Heart Institute, Jan Powers is director of nursing research and professional practice, and Jennifer L. Rechter is clinical nurse specialist for the medical intensive care unit, Parkview Health, Fort Wayne, Indiana.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Rechter', 'Affiliation': 'Michelle D. Wood is a clinical nurse specialist for Parkview Heart Institute, Jan Powers is director of nursing research and professional practice, and Jennifer L. Rechter is clinical nurse specialist for the medical intensive care unit, Parkview Health, Fort Wayne, Indiana.'}]","American journal of critical care : an official publication, American Association of Critical-Care Nurses",['10.4037/ajcc2019645']
239,31676522,Stress Management Intervention to Prevent Post-Intensive Care Syndrome-Family in Patients' Spouses.,"BACKGROUND


Post-intensive care syndrome-family (PICS-F) refers to acute and chronic psychological effects of critical care on family members of patients in intensive care units (ICUs). Evidence suggests that increased distress during the ICU stay increases risk of PICS-F. Sensation Awareness Focused Training (SĀF-T) is a new, promising stress management intervention, but the feasibility of such training during the ICU stay for family caregivers who are acting as the surrogate decision-maker for patients who are undergoing mechanical ventilation is unknown.
OBJECTIVES


To assess feasibility and acceptability of SĀF-T to inform a future larger randomized controlled trial.
METHODS


This randomized controlled trial of SĀF-T (n = 5) versus a control (n = 5) group was conducted at a level 1 trauma center. Participants assigned to SĀF-T completed 1 session daily for 3 days. Measures included enrollment rate, data completion rate, acceptability of SĀF-T, and symptoms of PICS-F. Scales used included Perceived Stress, Hospital Anxiety and Depression, Impact of Event, and National Institutes of Health Toolbox Emotion Battery.
RESULTS


Mean age was 58 (SD, 12) years; 70% of participants were female. Predetermined feasibility criteria were met in enrollment rate (67%), outcome measures completion rate (> 90%), and SĀF-T acceptability (100% of doses completed during the ICU stay) without adverse events. Stress scores after SĀF-T were significantly lower than scores before SĀF-T ( z  = -3.5,  P  = .01).
CONCLUSIONS


SĀF-T intervention during the ICU stay is feasible, acceptable, and may improve family caregivers' post-ICU outcomes. Larger clinical trial to assess the effectiveness of SĀF-T in preventing PICS-F seem warranted.",2019,"Stress scores after SĀF-T were significantly lower than scores before SĀF-T ( z  = -3.5,  P  = .01).
","[""Patients' Spouses"", 'Mean age was 58 (SD, 12) years; 70% of participants were female', 'family members of patients in intensive care units (ICUs']","['SĀF-T intervention', 'Stress Management Intervention', 'SĀF-T']","['SĀF-T acceptability', 'Stress scores', 'enrollment rate, data completion rate, acceptability of SĀF-T, and symptoms of PICS-F. Scales used included Perceived Stress, Hospital Anxiety and Depression, Impact of Event, and National Institutes of Health Toolbox Emotion Battery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162409', 'cui_str': 'Married Persons'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0150788', 'cui_str': 'Manage stress control'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0730321', 'cui_str': 'Punctate inner choroiditis'}, {'cui': 'C0222045'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}]",,0.0812182,"Stress scores after SĀF-T were significantly lower than scores before SĀF-T ( z  = -3.5,  P  = .01).
","[{'ForeName': 'Paula L', 'Initials': 'PL', 'LastName': 'Cairns', 'Affiliation': 'Paula L. Cairns is an assistant professor, Kevin E. Kip is a distinguished professor, and Harleah G. Buck and Carmen S. Rodriguez are associate professors, University of South Florida, Tampa, Florida. Zhan Liang is an assistant professor and Cindy L. Munro is a professor and dean, University of Miami, Coral Gables, Florida. pcairns@health.usf.edu.'}, {'ForeName': 'Harleah G', 'Initials': 'HG', 'LastName': 'Buck', 'Affiliation': 'Paula L. Cairns is an assistant professor, Kevin E. Kip is a distinguished professor, and Harleah G. Buck and Carmen S. Rodriguez are associate professors, University of South Florida, Tampa, Florida. Zhan Liang is an assistant professor and Cindy L. Munro is a professor and dean, University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Kip', 'Affiliation': 'Paula L. Cairns is an assistant professor, Kevin E. Kip is a distinguished professor, and Harleah G. Buck and Carmen S. Rodriguez are associate professors, University of South Florida, Tampa, Florida. Zhan Liang is an assistant professor and Cindy L. Munro is a professor and dean, University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Carmen S', 'Initials': 'CS', 'LastName': 'Rodriguez', 'Affiliation': 'Paula L. Cairns is an assistant professor, Kevin E. Kip is a distinguished professor, and Harleah G. Buck and Carmen S. Rodriguez are associate professors, University of South Florida, Tampa, Florida. Zhan Liang is an assistant professor and Cindy L. Munro is a professor and dean, University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Paula L. Cairns is an assistant professor, Kevin E. Kip is a distinguished professor, and Harleah G. Buck and Carmen S. Rodriguez are associate professors, University of South Florida, Tampa, Florida. Zhan Liang is an assistant professor and Cindy L. Munro is a professor and dean, University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Munro', 'Affiliation': 'Paula L. Cairns is an assistant professor, Kevin E. Kip is a distinguished professor, and Harleah G. Buck and Carmen S. Rodriguez are associate professors, University of South Florida, Tampa, Florida. Zhan Liang is an assistant professor and Cindy L. Munro is a professor and dean, University of Miami, Coral Gables, Florida.'}]","American journal of critical care : an official publication, American Association of Critical-Care Nurses",['10.4037/ajcc2019668']
240,32267031,"The effect of aromatherapy with rose and lavender on anxiety, surgical site pain, and extubation time after open-heart surgery: A double-center randomized controlled trial.","To determine the effect of aromatherapy with rose and lavender on the patient outcomes after open-heart surgery (OHS). In the clinical trial, patients were randomized to four groups. One group received routine care, the placebo group received a cotton swab soaked in water and the other two groups received either a cotton swab containing three drops of rose or lavender essence (0.2 ml). A total of 160 patients were randomized into four groups. Intergroup anxiety was not significantly different; however, the reciprocal time-group effect was significant among the four groups. The extubation time was significant among the four groups which related to rose essence group compared with the control group (p < .001) and placebo group (p = .029). The surgical site pain was significant in the rose essence and lavender groups compared to the control group. Aromatherapy can reduce extubation time, surgical site pain severity, and anxiety in patients undergoing OHS.",2020,The extubation time was significant among the four groups which related to rose essence group compared with the control group (p < .001) and placebo group (p = .029).,"['patients undergoing OHS', '160 patients', 'patient outcomes after open-heart surgery (OHS', 'after open-heart surgery']","['aromatherapy with rose and lavender', 'placebo', 'cotton swab soaked', 'Aromatherapy', 'cotton swab containing three drops of rose or lavender essence', 'routine care, the placebo']","['extubation time', 'Intergroup anxiety', 'extubation time, surgical site pain severity, and anxiety', 'surgical site pain', 'anxiety, surgical site pain, and extubation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0268353', 'cui_str': 'Cutis laxa, x-linked'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}]","[{'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010196', 'cui_str': 'Gossypium'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",160.0,0.0958103,The extubation time was significant among the four groups which related to rose essence group compared with the control group (p < .001) and placebo group (p = .029).,"[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Babatabar Darzi', 'Affiliation': 'Trauma Research Center, Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Vahedian-Azimi', 'Affiliation': 'Trauma Research Center, Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Ghasemi', 'Affiliation': 'Trauma Research Center, Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Ebadi', 'Affiliation': 'Behavioral Sciences Research Center, Life Style Institute, Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Thozhukat', 'Initials': 'T', 'LastName': 'Sathyapalan', 'Affiliation': 'Department of Academic Diabetes, Endocrinology and Metabolism, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': 'Halal Research Center of IRI, FDA, Tehran, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6698']
241,31743177,Global and Regional Respiratory Mechanics During Robotic-Assisted Laparoscopic Surgery: A Randomized Study.,"BACKGROUND


Pneumoperitoneum and nonphysiological positioning required for robotic surgery increase cardiopulmonary risk because of the use of larger airway pressures (Paws) to maintain tidal volume (VT). However, the quantitative partitioning of respiratory mechanics and transpulmonary pressure (PL) during robotic surgery is not well described. We tested the following hypothesis: (1) the components of driving pressure (transpulmonary and chest wall components) increase in a parallel fashion at robotic surgical stages (Trendelenburg and robot docking); and (2) deep, when compared to routine (moderate), neuromuscular blockade modifies those changes in PLs as well as in regional respiratory mechanics.
METHODS


We studied 35 American Society of Anesthesiologists (ASA) I-II patients undergoing elective robotic surgery. Airway and esophageal balloon pressures and respiratory flows were measured to calculate respiratory mechanics. Regional lung aeration and ventilation was assessed with electrical impedance tomography and level of neuromuscular blockade with acceleromyography. During robotic surgical stages, 2 crossover randomized groups (conditions) of neuromuscular relaxation were studied: Moderate (1 twitch in the train-of-four stimulation) and Deep (1-2 twitches in the posttetanic count).
RESULTS


Pneumoperitoneum was associated with increases in driving pressure, tidal changes in PL, and esophageal pressure (Pes). Steep Trendelenburg position during robot docking was associated with further worsening of the respiratory mechanics. The fraction of driving pressures that partitioned to the lungs decreased from baseline (63% ± 15%) to Trendelenburg position (49% ± 14%, P < .001), due to a larger increase in chest wall elastance (Ecw; 12.7 ± 7.6 cm H2O·L) than in lung elastance (EL; 4.3 ± 5.0 cm H2O·L, P < .001). Consequently, from baseline to Trendelenburg, the component of Paw affecting the chest wall increased by 6.6 ± 3.1 cm H2O, while PLs increased by only 3.4 ± 3.1 cm H2O (P < .001). PL and driving pressures were larger at surgery end than at baseline and were accompanied by dorsal aeration loss. Deep neuromuscular blockade did not change respiratory mechanics, regional aeration and ventilation, and hemodynamics.
CONCLUSIONS


In robotic surgery with pneumoperitoneum, changes in ventilatory driving pressures during Trendelenburg and robot docking are distributed less to the lungs than to the chest wall as compared to routine mechanical ventilation for supine patients. This effect of robotic surgery derives from substantially larger increases in Ecw than ELs and reduces the risk of excessive PLs. Deep neuromuscular blockade does not meaningfully change global or regional lung mechanics.",2019,"RESULTS


Pneumoperitoneum was associated with increases in driving pressure, tidal changes in PL, and esophageal pressure (Pes).",['35 American Society of Anesthesiologists (ASA) I-II patients undergoing'],"['robotic surgery with pneumoperitoneum', 'Global and Regional Respiratory Mechanics During Robotic-Assisted Laparoscopic Surgery', 'robotic surgery', 'acceleromyography', 'elective robotic surgery']","['Paw affecting the chest wall', 'fraction of driving pressures', 'quantitative partitioning of respiratory mechanics and transpulmonary pressure (PL', 'Regional lung aeration and ventilation', 'driving pressure, tidal changes in PL, and esophageal pressure (Pes', 'chest wall elastance', 'ventilatory driving pressures', 'Airway and esophageal balloon pressures and respiratory flows', 'PL and driving pressures', 'change respiratory mechanics, regional aeration and ventilation, and hemodynamics']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C3805242', 'cui_str': 'Acceleromyography'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205076', 'cui_str': 'Chest Wall'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0232531', 'cui_str': 'Esophageal pressure (observable entity)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0179752', 'cui_str': 'Esophageal balloon, device (physical object)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",35.0,0.0702256,"RESULTS


Pneumoperitoneum was associated with increases in driving pressure, tidal changes in PL, and esophageal pressure (Pes).","[{'ForeName': 'Julio C', 'Initials': 'JC', 'LastName': 'Brandão', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Marcos A', 'Initials': 'MA', 'LastName': 'Lessa', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Motta-Ribeiro', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Soshi', 'Initials': 'S', 'LastName': 'Hashimoto', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Luis Felipe', 'Initials': 'LF', 'LastName': 'Paula', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Torsani', 'Affiliation': 'Cardio-Pulmonary Department, Pulmonary Division, Heart Institute (Incor), University of São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Linh', 'Initials': 'L', 'LastName': 'Le', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Bao', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Eikermann', 'Affiliation': 'Department of Urology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Dahl', 'Affiliation': 'Department of Urology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Tabatabaei', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Marcelo B P', 'Initials': 'MBP', 'LastName': 'Amato', 'Affiliation': 'Cardio-Pulmonary Department, Pulmonary Division, Heart Institute (Incor), University of São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Marcos F', 'Initials': 'MF', 'LastName': 'Vidal Melo', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004289']
242,32269011,Autologous fat graft assisted by stromal vascular fraction improves facial skin quality: A randomized controlled trial.,"BACKGROUND


Cell-assisted lipotransfer (CAL) promotes the survival of fat grafts with high vascular density and improves skin quality by increasing collagen content. However, no study has quantified the changes on the skin surface, and rigorous methodological evaluations are still lacking.
DESIGN


Fifty patients were recruited and randomly divided into two groups: an experimental group (n = 25) that underwent a stromal vascular fraction (SVF)-assisted fat graft and a control group (n = 25) that underwent fat graft only.
METHODS


The SVF cells were counted, tested in terms of viability, and characterized. The volumes of whole faces were determined by using a 3D scanner and Geomagic software preoperation, immediately after surgery, and 6 months postoperation. Facial skin qualities, including spots, wrinkles, texture, pores, UV spots, brown spots, red areas, and porphyrins, were detected by a VISIA skin detector preoperation and 6 months postoperation. A visual analog scale was used for clinical evaluation.
RESULTS


The cell pellet contained 1-3 × 10 7 /mL of fresh SVF cells. The cell viability exceeded 98%. The immunophenotyping characteristics and stemness were consistent with the features of adipose- derived stem cells (ADSCs). The survival rate of SVF-enriched fat grafts was significantly higher than that of control grafts: 77.6%±11.6% versus 56.2%±9.5% (p<0.001). The VISIA values of wrinkles (19.3 ± 6.6 versus 10.9 ± 5.5, p<0.001) and texture (15.8 ± 7.0 versus 10.3 ± 5.0, p<0.01) were significantly higher in SVF-enriched group than in control group at 6 months postoperation. During long-term follow-up, the majority of patients in both groups were satisfied with the final facial esthetic results.
CONCLUSIONS


Our results demonstrated the positive outcomes of autologous SVF-assisted fat graft in improving facial skin quality and its promising application potential in clinical settings. This study is registered at www. ClinicalTrials.gov, number NCT02923219.",2020,"During long-term follow-up, the majority of patients in both groups were satisfied with the final facial esthetic results.
",['Fifty patients'],"['autologous SVF-assisted fat graft', 'Cell-assisted lipotransfer (CAL', 'Autologous fat graft assisted by stromal vascular fraction', 'stromal vascular fraction (SVF)-assisted fat graft and a control group (n\u202f=\u202f25) that underwent fat graft only']","['VISIA values of wrinkles', 'survival rate of SVF-enriched fat grafts', 'Facial skin qualities, including spots, wrinkles, texture, pores, UV spots, brown spots, red areas, and porphyrins', 'skin quality', 'cell viability', 'facial skin quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0844767', 'cui_str': 'Grafting of fat'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C4076692', 'cui_str': 'Autologous fat'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0844767', 'cui_str': 'Grafting of fat'}, {'cui': 'C0222084', 'cui_str': 'Skin structure of face'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032712', 'cui_str': 'Porphyrin'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007620', 'cui_str': 'Cell Viability'}]",50.0,0.137992,"During long-term follow-up, the majority of patients in both groups were satisfied with the final facial esthetic results.
","[{'ForeName': 'Yating', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Department of Plastic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huai-hai West Road, 221002 Xuzhou, Jiangsu, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Plastic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huai-hai West Road, 221002 Xuzhou, Jiangsu, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Plastic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huai-hai West Road, 221002 Xuzhou, Jiangsu, China.'}, {'ForeName': 'Aijun', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'Department of Plastic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huai-hai West Road, 221002 Xuzhou, Jiangsu, China. Electronic address: zaj165@126.com.'}, {'ForeName': 'Peisheng', 'Initials': 'P', 'LastName': 'Jin', 'Affiliation': 'Department of Plastic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huai-hai West Road, 221002 Xuzhou, Jiangsu, China. Electronic address: 100000401006@xzhmu.edu.cn.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2019.11.010']
243,30474401,"Can lifelike baby dolls reduce symptoms of anxiety, agitation, or aggression for people with dementia in long-term care? Findings from a pilot randomised controlled trial.","Objectives:  To compare a lifelike baby doll intervention for reducing anxiety, agitation, and aggression in older people with dementia in long-term care (LTC), with usual facility care; and explore the perceptions of care staff about doll therapy.  Method:  Pilot, mixed-methods, parallel, randomised controlled trial, with follow-up semi-structured interviews. Thirty-five residents from five LTC facilities in Queensland, Australia were randomised to the lifelike baby doll intervention (three, 30-minute, individual, non-facilitated sessions per week) or usual care. Outcomes were changes in levels of anxiety, agitation, and aggression after the 3-week intervention, and short-term effects at week 1. Following intention-to-treat principles, repeated measure MANOVA was undertaken. Qualitative interviews involved five staff.  Results:  The doll intervention did not significantly reduce residents' anxiety, agitation, or aggression when compared to usual care at weeks 3 (primary outcome) and 1 (secondary outcome). However, there was a significant group-by-time interaction for the outcome of pleasure - the doll group showed a greater increase in displays of pleasure at week 3 compared to baseline than usual care ( F (1,31) = 4.400,  p  = 0.044; Cohen's  d  = 0.74). Staff perceived benefits for residents included emotional comfort, a calming effect, and providing a purposeful activity. Perceived limitations were that doll therapy may only be suitable for some individuals, some of the time, and the potential for residents to care for the doll at the expense of their health.  Conclusions:  Doll therapy can provide some residents with enjoyment and purposeful engagement. Further research should focus on understanding the individual characteristics and circumstances in which residents most benefit.",2019,"The doll intervention did not significantly reduce residents' anxiety, agitation, or aggression when compared to usual care at weeks 3 (primary outcome) and 1 (secondary outcome).","['Thirty-five residents from five LTC facilities in Queensland, Australia', 'older people with dementia in long-term care (LTC), with usual facility care']","['lifelike baby doll intervention', 'lifelike baby doll intervention (three, 30-minute, individual, non-facilitated sessions per week) or usual care']","['anxiety, agitation, and aggression', ""residents' anxiety, agitation, or aggression"", 'displays of pleasure', 'anxiety, agitation, or aggression', 'levels of anxiety, agitation, and aggression']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C4521843', 'cui_str': 'CDR'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0023977'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}]",35.0,0.104585,"The doll intervention did not significantly reduce residents' anxiety, agitation, or aggression when compared to usual care at weeks 3 (primary outcome) and 1 (secondary outcome).","[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Moyle', 'Affiliation': 'a Menzies Health Institute Queensland, Griffith University , Nathan , Brisbane, Queensland , Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Murfield', 'Affiliation': 'a Menzies Health Institute Queensland, Griffith University , Nathan , Brisbane, Queensland , Australia.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'a Menzies Health Institute Queensland, Griffith University , Nathan , Brisbane, Queensland , Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Beattie', 'Affiliation': 'c School of Nursing, Queensland University of Technology, Kelvin Grove , Brisbane , Queensland , Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Draper', 'Affiliation': 'd School of Psychiatry, University of New South Wales , Sydney , Australia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Ownsworth', 'Affiliation': 'a Menzies Health Institute Queensland, Griffith University , Nathan , Brisbane, Queensland , Australia.'}]",Aging & mental health,['10.1080/13607863.2018.1498447']
244,30875425,"Effects of Early Versus Delayed Excision and Grafting on Restoring the Functionality of Deep Burn-Injured Hands: A Double-Blind, Randomized Parallel Clinical Trial.","Hand burns have major impacts on daily activities. An interdisciplinary and multifaceted approach is necessary to effectively treat these burns. Generally, hands are common sites for burn injuries. It is known that Early Excision and Grafting (EEG) of deep burn wounds can decrease scar and subsequent contracture formation compared with Delayed Excision and Grafting (DEG) method. Accordingly, this study aimed to compare the effects of these procedures on function of hands with deep burns, by using the Michigan Hand Questionnaire (MHQ). In this double-blind randomized clinical trial, we evaluated a total of 50 patients (age range: 15-70 years) with deep second-degree burns of both hands from January 2013 to December 2015. The subjects were randomly divided into two groups, treatment (EEG) and control (DEG) groups (25 patients per group). They followed up postoperatively for 3 months. MHQ was completed for each of them to determine the function of the hands, pain sensation, limitation of daily activities, overall satisfaction, and cosmetic appearance during follow-up. Data were analyzed in the groups using SPSS version 16. Baseline characteristics of the groups were matched. In early postoperation, hand functions and daily activities, gross appearance, and pain sensation were better in EEG group. After 1 and 3 months, no significant difference was detected between the groups except for patient satisfaction which was better in EEG group. Also, EEG group was associated with a significant shorter hospital stay and lower treatment costs compared with DEG group. Graft take rate was similar in both groups. EEG is recognized as the standard treatment for deep skin burns, but we did not find any significant difference between effects of EEG and DEG on hand functions although EEG group had shorter hospital stay and lower treatment costs compared with DEG. The main goal of treatment of hand burns is restoration of the hand functions. Based on our findings, hand function was not related to the type of surgery. Also, as all wounds in both surgical groups healed less than 3 weeks, the authors suggest that the excision time limit could be change in our burn center from 10 days to 2 to 3 weeks when we use sheet graft as for hands.",2019,"After 1 and 3 months, no significant difference was detected between the groups except for patient satisfaction which was better in EEG group.","['50 patients (age range: 15-70 years) with deep second-degree burns of both hands from January 2013 to December 2015', 'Deep Burn-Injured Hands']","['Early Versus Delayed Excision and Grafting', 'MHQ', 'treatment (EEG) and control (DEG']","['function of the hands, pain sensation, limitation of daily activities, overall satisfaction, and cosmetic appearance', 'hospital stay', 'hand functions and daily activities, gross appearance, and pain sensation', 'daily activities', 'Graft take rate', 'patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0332687', 'cui_str': 'Second degree burn injury (morphologic abnormality)'}, {'cui': 'C0230377', 'cui_str': 'Both hands (body structure)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",50.0,0.0361097,"After 1 and 3 months, no significant difference was detected between the groups except for patient satisfaction which was better in EEG group.","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Ayaz', 'Affiliation': 'Division of Burn and Reconstructive Surgery, Department of Surgery, Shiraz, Iran.'}, {'ForeName': 'Mohammad Yasin', 'Initials': 'MY', 'LastName': 'Karami', 'Affiliation': 'Division of Burn and Reconstructive Surgery, Department of Surgery, Shiraz, Iran.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Deilami', 'Affiliation': 'Division of Burn and Reconstructive Surgery, Department of Surgery, Shiraz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Moradzadeh', 'Affiliation': 'Physiotherapy and Rehabilitation Department, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of burn care & research : official publication of the American Burn Association,['10.1093/jbcr/irz033']
245,32271184,Pressure Pain Tolerance Predicts the Success of Emotional Awareness and Expression Therapy in Patients With Fibromyalgia.,"OBJECTIVES


Quantitative sensory testing may help predict treatment responses in individuals with chronic pain. Our objective was to determine whether evoked pain sensitivity at baseline predicted preferential treatment responses to either emotional awareness and expression therapy (EAET) or cognitive behavioral therapy (CBT) in individuals with fibromyalgia (FM).
METHODS


This was a secondary analysis of a previous randomized clinical trial, in which individuals with FM were randomized to EAET, CBT, or Education as a control intervention. Only females who completed baseline and post-treatment assessments were analyzed (n=196). The primary outcome was change in overall clinical pain severity from pretreatment to posttreatment, and the primary predictor of interest was pressure pain tolerance at baseline.
RESULTS


Among patients with low pain tolerance at baseline (n=154), both EAET and CBT led to small but significant improvements in clinical pain severity (CBT mean=0.66, 95% confidence interval [0.24-1.07]; EAET mean=0.76 [0.34-1.17]). Conversely, in patients with normal pain tolerance (n=42), there was no significant improvement in clinical pain after CBT (0.13 [-0.88 to 1.14]), a small improvement after FM Education (0.81 [0.14-1.48]), but a much larger and statistically significant improvement after EAET (2.14 [1.23-3.04]).
DISCUSSION


Normal levels of pressure pain tolerance at baseline predicted greater improvement in clinical pain severity after EAET than CBT. Quantitative sensory testing may provide insights about individual responses to psychologically based therapies for individuals with chronic pain.",2020,"Conversely, in patients with normal pain tolerance (n=42), there was no significant improvement in clinical pain after CBT (0.13","['Patients with Fibromyalgia', 'individuals with chronic pain', 'individuals with fibromyalgia']","['Quantitative sensory testing (QST', 'QST', 'emotional awareness and expression therapy (EAET) or cognitive behavioral therapy (CBT']","['clinical pain severity', 'normal pain tolerance', 'overall clinical pain severity', 'pressure pain tolerance', 'low pain tolerance', 'clinical pain', 'evoked pain sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}]",,0.337402,"Conversely, in patients with normal pain tolerance (n=42), there was no significant improvement in clinical pain after CBT (0.13","[{'ForeName': 'Tiffany R', 'Initials': 'TR', 'LastName': 'Bellomo', 'Affiliation': 'Department of Anesthesiology, Chronic Pain and Fatigue Research Center.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Schrepf', 'Affiliation': 'Department of Anesthesiology, Chronic Pain and Fatigue Research Center.'}, {'ForeName': 'Grant H', 'Initials': 'GH', 'LastName': 'Kruger', 'Affiliation': 'Department of Anesthesiology, Chronic Pain and Fatigue Research Center.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Lumley', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Schubiner', 'Affiliation': 'Department of Internal Medicine, Providence Park Hospital, Ascension Health, Novi.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Clauw', 'Affiliation': 'Department of Anesthesiology, Chronic Pain and Fatigue Research Center.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': 'Department of Anesthesiology, Chronic Pain and Fatigue Research Center.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Harte', 'Affiliation': 'Department of Anesthesiology, Chronic Pain and Fatigue Research Center.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000829']
246,31189985,"Theta band high definition transcranial alternating current stimulation, but not transcranial direct current stimulation, improves associative memory performance.","Associative memory (AM) deficits are common in neurodegenerative disease and novel therapies aimed at improving these faculties are needed. Theta band oscillations within AM networks have been shown to be important for successful memory encoding and modulating these rhythms represents a promising strategy for cognitive enhancement. Transcranial alternating current stimulation (TACS) has been hypothesized to entrain and increase power of endogenous brain rhythms. For this reason, we hypothesized that focal delivery of theta band electrical current, using high-definition TACS, would result in improved AM performance compared to sham stimulation or transcranial direct current stimulation (TDCS). In this pilot study, 60 healthy subjects were randomized to receive high definition TACS, high definition TDCS, or sham stimulation delivered to the right fusiform cortex during encoding of visual associations. Consistent with our hypothesis, improved AM performance was observed in the TACS group, while TDCS had no effect. However, TACS also resulted in improved correct rejection of never seen items, reduced false memory, and reduced forgetting, suggesting the effect may not be specific for AM processes. Overall, this work informs strategies for improving associative memory and suggests alternating current is more effective than direct current stimulation in some contexts.",2019,"However, TACS also resulted in improved correct rejection of never seen items, reduced false memory, and reduced forgetting, suggesting the effect may not be specific for AM processes.",['60 healthy subjects'],"['TDCS', 'transcranial direct current stimulation (TDCS', 'high definition TACS, high definition TDCS, or sham stimulation', 'Transcranial alternating current stimulation (TACS', 'TACS']","['associative memory performance', 'correct rejection', 'AM performance', 'Associative memory (AM) deficits']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}]","[{'cui': 'C1285654', 'cui_str': 'Ability to remember'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0233794', 'cui_str': 'Memory Deficits'}]",60.0,0.164414,"However, TACS also resulted in improved correct rejection of never seen items, reduced false memory, and reduced forgetting, suggesting the effect may not be specific for AM processes.","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lang', 'Affiliation': 'Hotchkiss Brain Institute, Cumming School of Medicine, Calgary, AB, Canada.'}, {'ForeName': 'Liu Shi', 'Initials': 'LS', 'LastName': 'Gan', 'Affiliation': 'Hotchkiss Brain Institute, Cumming School of Medicine, Calgary, AB, Canada.'}, {'ForeName': 'Tazrina', 'Initials': 'T', 'LastName': 'Alrazi', 'Affiliation': 'Hotchkiss Brain Institute, Cumming School of Medicine, Calgary, AB, Canada.'}, {'ForeName': 'Oury', 'Initials': 'O', 'LastName': 'Monchi', 'Affiliation': 'Hotchkiss Brain Institute, Cumming School of Medicine, Calgary, AB, Canada. oury.monchi@ucalgary.ca.'}]",Scientific reports,['10.1038/s41598-019-44680-8']
247,31566937,Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer.,"BACKGROUND


The efficacy and safety of cabazitaxel, as compared with an androgen-signaling-targeted inhibitor (abiraterone or enzalutamide), in patients with metastatic castration-resistant prostate cancer who were previously treated with docetaxel and had progression within 12 months while receiving the alternative inhibitor (abiraterone or enzalutamide) are unclear.
METHODS


We randomly assigned, in a 1:1 ratio, patients who had previously received docetaxel and an androgen-signaling-targeted inhibitor (abiraterone or enzalutamide) to receive cabazitaxel (at a dose of 25 mg per square meter of body-surface area intravenously every 3 weeks, plus prednisone daily and granulocyte colony-stimulating factor) or the other androgen-signaling-targeted inhibitor (either 1000 mg of abiraterone plus prednisone daily or 160 mg of enzalutamide daily). The primary end point was imaging-based progression-free survival. Secondary end points of survival, response, and safety were assessed.
RESULTS


A total of 255 patients underwent randomization. After a median follow-up of 9.2 months, imaging-based progression or death was reported in 95 of 129 patients (73.6%) in the cabazitaxel group, as compared with 101 of 126 patients (80.2%) in the group that received an androgen-signaling-targeted inhibitor (hazard ratio, 0.54; 95% confidence interval [CI], 0.40 to 0.73; P<0.001). The median imaging-based progression-free survival was 8.0 months with cabazitaxel and 3.7 months with the androgen-signaling-targeted inhibitor. The median overall survival was 13.6 months with cabazitaxel and 11.0 months with the androgen-signaling-targeted inhibitor (hazard ratio for death, 0.64; 95% CI, 0.46 to 0.89; P = 0.008). The median progression-free survival was 4.4 months with cabazitaxel and 2.7 months with an androgen-signaling-targeted inhibitor (hazard ratio for progression or death, 0.52; 95% CI, 0.40 to 0.68; P<0.001), a prostate-specific antigen response occurred in 35.7% and 13.5% of the patients, respectively (P<0.001), and tumor response was noted in 36.5% and 11.5% (P = 0.004). Adverse events of grade 3 or higher occurred in 56.3% of patients receiving cabazitaxel and in 52.4% of those receiving an androgen-signaling-targeted inhibitor. No new safety signals were observed.
CONCLUSIONS


Cabazitaxel significantly improved a number of clinical outcomes, as compared with the androgen-signaling-targeted inhibitor (abiraterone or enzalutamide), in patients with metastatic castration-resistant prostate cancer who had been previously treated with docetaxel and the alternative androgen-signaling-targeted agent (abiraterone or enzalutamide). (Funded by Sanofi; CARD ClinicalTrials.gov number, NCT02485691.).",2019,Adverse events of grade 3 or higher occurred in 56.3% of patients receiving cabazitaxel and in 52.4% of those receiving an androgen-signaling-targeted inhibitor.,"['Metastatic Prostate Cancer', '255 patients underwent randomization', 'patients with metastatic castration-resistant prostate cancer who had been previously treated with', 'patients with metastatic castration-resistant prostate cancer who were previously treated with']","['docetaxel', 'androgen-signaling-targeted inhibitor (abiraterone or enzalutamide', 'alternative inhibitor (abiraterone or enzalutamide', 'prednisone daily and granulocyte colony-stimulating factor) or the other androgen-signaling-targeted inhibitor (either 1000 mg of abiraterone plus prednisone', 'cabazitaxel', 'inhibitor (abiraterone or enzalutamide', 'Cabazitaxel versus Abiraterone or Enzalutamide', 'docetaxel and an androgen-signaling-targeted inhibitor (abiraterone or enzalutamide) to receive cabazitaxel', 'docetaxel and the alternative androgen-signaling-targeted agent (abiraterone or enzalutamide']","['imaging-based progression-free survival', 'prostate-specific antigen response', 'Adverse events', 'tumor response', 'imaging-based progression or death', 'median overall survival', 'median imaging-based progression-free survival', 'median progression-free survival', 'survival, response, and safety']","[{'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2830183', 'cui_str': 'cabazitaxel'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",255.0,0.234362,Adverse events of grade 3 or higher occurred in 56.3% of patients receiving cabazitaxel and in 52.4% of those receiving an androgen-signaling-targeted inhibitor.,"[{'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'de Wit', 'Affiliation': ""From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne-Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d'Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) - all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) - both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome - both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.).""}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'de Bono', 'Affiliation': ""From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne-Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d'Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) - all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) - both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome - both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.).""}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': ""From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne-Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d'Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) - all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) - both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome - both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.).""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': ""From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne-Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d'Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) - all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) - both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome - both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.).""}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': ""From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne-Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d'Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) - all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) - both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome - both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.).""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Wülfing', 'Affiliation': ""From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne-Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d'Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) - all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) - both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome - both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.).""}, {'ForeName': 'Gero', 'Initials': 'G', 'LastName': 'Kramer', 'Affiliation': ""From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne-Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d'Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) - all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) - both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome - both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.).""}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Eymard', 'Affiliation': ""From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne-Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d'Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) - all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) - both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome - both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.).""}, {'ForeName': 'Aristotelis', 'Initials': 'A', 'LastName': 'Bamias', 'Affiliation': ""From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne-Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d'Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) - all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) - both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome - both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.).""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Carles', 'Affiliation': ""From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne-Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d'Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) - all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) - both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome - both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.).""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Iacovelli', 'Affiliation': ""From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne-Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d'Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) - all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) - both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome - both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.).""}, {'ForeName': 'Bohuslav', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': ""From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne-Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d'Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) - all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) - both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome - both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.).""}, {'ForeName': 'Ásgerður', 'Initials': 'Á', 'LastName': 'Sverrisdóttir', 'Affiliation': ""From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne-Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d'Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) - all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) - both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome - both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.).""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Theodore', 'Affiliation': ""From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne-Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d'Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) - all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) - both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome - both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.).""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Feyerabend', 'Affiliation': ""From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne-Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d'Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) - all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) - both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome - both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.).""}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Helissey', 'Affiliation': ""From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne-Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d'Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) - all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) - both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome - both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.).""}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Ozatilgan', 'Affiliation': ""From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne-Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d'Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) - all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) - both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome - both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.).""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Geffriaud-Ricouard', 'Affiliation': ""From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne-Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d'Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) - all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) - both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome - both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.).""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Castellano', 'Affiliation': ""From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne-Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d'Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) - all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) - both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome - both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1911206']
248,32253540,"Effects of a Universal School-Based Mental Health Program on the Self-concept, Coping Skills, and Perceptions of Social Support of Students with Developmental Disabilities.","In a cluster randomized control trial, a school-based mental health program combining mental health literacy and dialectical behavior skills was implemented by teachers to determine effects on protective factors related to resilience for students in 3rd-12th grade. As part of a larger study, a subsample of 113 students with developmental disabilities attending 37 classrooms participated. Student-reported measures of self-concept, coping skills, and social support were collected three times in the year. Results indicated large effect sizes for the program on all measures, which pertain to time × group interactions (g = 1.53, 1.91, and 0.86 for self-concept, coping, and social support respectively). Follow-up analyses indicated that gains for the intervention schools primarily occurred between the first two assessment periods when the majority of program content was delivered. Implications for universal school-based mental health programming for students with developmental disabilities are discussed.",2020,"Results indicated large effect sizes for the program on all measures, which pertain to time × group interactions (g = 1.53, 1.91, and 0.86 for self-concept, coping, and social support respectively).","['students with developmental disabilities', 'students in 3rd-12th grade', 'Students with Developmental Disabilities', '113 students with developmental disabilities attending 37 classrooms participated']","['school-based mental health program combining mental health literacy and dialectical behavior skills', 'universal school-based mental health programming', 'Universal School-Based Mental Health Program']","['self-concept, coping skills, and social support']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175671', 'cui_str': 'Universal'}]","[{'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",113.0,0.0117746,"Results indicated large effect sizes for the program on all measures, which pertain to time × group interactions (g = 1.53, 1.91, and 0.86 for self-concept, coping, and social support respectively).","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of Educational and Counselling Psychology & Special Education, University of British Columbia, #2420-2125 Main Mall, Vancouver, BC, V6T 1Z4, Canada. Jennifer.Katz@ubc.ca.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Knight', 'Affiliation': 'Department of Educational and Counselling Psychology & Special Education, University of British Columbia, #2420-2125 Main Mall, Vancouver, BC, V6T 1Z4, Canada.'}, {'ForeName': 'Sterett H', 'Initials': 'SH', 'LastName': 'Mercer', 'Affiliation': 'Department of Educational and Counselling Psychology & Special Education, University of British Columbia, #2420-2125 Main Mall, Vancouver, BC, V6T 1Z4, Canada.'}, {'ForeName': 'Sarah Y', 'Initials': 'SY', 'LastName': 'Skinner', 'Affiliation': 'Department of Educational and Counselling Psychology & Special Education, University of British Columbia, #2420-2125 Main Mall, Vancouver, BC, V6T 1Z4, Canada.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04472-w']
249,32227755,Initial Invasive or Conservative Strategy for Stable Coronary Disease.,"BACKGROUND


Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain.
METHODS


We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction.
RESULTS


Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32).
CONCLUSIONS


Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).",2020,"At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0).","['patients with stable coronary disease and moderate or severe ischemia', 'Stable Coronary Disease', '5179 patients with moderate or severe ischemia to an']","['initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed', 'invasive intervention plus medical therapy']","['death from cardiovascular causes or myocardial infarction', 'risk of ischemic cardiovascular events or death', 'definition of myocardial infarction', 'procedural myocardial infarctions of uncertain clinical importance', 'composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest', 'cumulative event rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",5179.0,0.217237,"At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0).","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Roxy', 'Initials': 'R', 'LastName': 'Senior', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'López-Sendón', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Leslee J', 'Initials': 'LJ', 'LastName': 'Shaw', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Sidhu', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Ruzyllo', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Gosselin', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Balram', 'Initials': 'B', 'LastName': 'Bhargava', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Min', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'G B John', 'Initials': 'GBJ', 'LastName': 'Mancini', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Berman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Picard', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Raymond Y', 'Initials': 'RY', 'LastName': 'Kwong', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Mangalath N', 'Initials': 'MN', 'LastName': 'Krishnan', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elghamaz', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Nagaraja', 'Initials': 'N', 'LastName': 'Moorthy', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Whady A', 'Initials': 'WA', 'LastName': 'Hueb', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Demkow', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Kreton', 'Initials': 'K', 'LastName': 'Mavromatis', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Bockeria', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Peteiro', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Miller', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Szwed', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Doerr', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Selvanayagam', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Held', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Kohsaka', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Mavromichalis', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Kirby', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Neal O', 'Initials': 'NO', 'LastName': 'Jeffries', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Harrell', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Broderick', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'T Bruce', 'Initials': 'TB', 'LastName': 'Ferguson', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Williams', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915922']
250,32266682,Canine Assisted Occupational Therapy for Children on the Autism Spectrum: A Pilot Randomised Control Trial.,"Children on the autism spectrum frequently display difficulties engaging with people and with functional tasks. A pilot, randomised control trial was completed to explore the impact of canine assisted occupational therapy on the on-task behaviours and goal attainment of autistic children when compared to occupational therapy sessions as usual. Twenty-two children between the ages of 4, and 6 years and 11 months, were randomly placed in either the treatment group (n-11) or waitlist control group (n = 11). Results showed that although there was a positive trend for on-task behaviour and goal attainment within the treatment group, results were not statistically significant. These results support the need for further research in the area of canine assisted occupational therapy for autistic children.",2020,"A pilot, randomised control trial was completed to explore the impact of canine assisted occupational therapy on the on-task behaviours and goal attainment of autistic children when compared to occupational therapy sessions as usual.","['Children on the Autism Spectrum', 'Twenty-two children between the ages of 4, and 6\xa0years and 11 months', 'autistic children']","['canine assisted occupational therapy', 'occupational therapy sessions', 'Canine Assisted Occupational Therapy', 'waitlist control group']",['task behaviour and goal attainment'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",22.0,0.0455305,"A pilot, randomised control trial was completed to explore the impact of canine assisted occupational therapy on the on-task behaviours and goal attainment of autistic children when compared to occupational therapy sessions as usual.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia. j.r.hill@uq.net.au.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ziviani', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Carlie', 'Initials': 'C', 'LastName': 'Driscoll', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Ai Lin', 'Initials': 'AL', 'LastName': 'Teoh', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Jia Min', 'Initials': 'JM', 'LastName': 'Chua', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Cawdell-Smith', 'Affiliation': 'School of Agriculture and Food Sciences, The University of Queensland, Brisbane, Australia.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04483-7']
251,31864818,A Comparison of Open-Construct PEEK Suture Anchor and Non-Vented Biocomposite Suture Anchor in Arthroscopic Rotator Cuff Repair: A Prospective Randomized Clinical Trial.,"PURPOSE


To compare radiologic bone ingrowth and the clinical outcomes of an open-construct (PEEK) (polyether ether ketone) suture anchor with those of a non-vented biocomposite suture anchor in patients with arthroscopic rotator cuff repair.
METHODS


Sixty-nine patients were randomly allocated into 2 groups based on type of suture anchors used for rotator cuff repair; group 1: open-construct PEEK anchor (36 patients), group 2: non-vented biocomposite anchor (33 patients). The status of bone ingrowth into the anchor and the presence of cyst formation were evaluated at 6 months postoperatively by computed tomography scan using the Modified Barber's ossification scale. The American Shoulder and Elbow Surgeons score, Constant score, and visual analog scale score for pain and range of motion were evaluated. Magnetic resonance imaging or ultrasonography was performed at 12 months postoperatively to examine the integrity of the repaired rotator cuff tendon.
RESULTS


Significant improvements in shoulder function and pain relief were observed regardless of the anchor used (both Group 1 and 2; P < .001). No differences were found in functional scores and range of motion between the 2 groups. Group 1 showed better bone ingrowth grades than group 2 (poor 2.8 vs 24.2%, fair 27.8 vs 39.4%, good 38.9 vs 33.3%, and excellent 30.6 vs 3.0%; P < .001). The rate of cyst formation around the anchor on the 6 months' postoperative computed tomography (group 1: 14% and group 2: 12%) and re-tear rate at 12 months (5% each) showed no difference between the 2 groups.
CONCLUSIONS


Shoulder function was improved after complete rotator cuff repair and similar clinical outcomes were achieved regardless of suture anchor material and shape. However, the open-construct PEEK anchor provided better bone ingrowth into the anchor than the non-vented biocomposite anchor at 6 months after arthroscopic rotator cuff repair.
LEVEL OF EVIDENCE


Level I; Prospective Randomized Trial.",2020,"RESULTS


Significant improvements in shoulder function and pain relief were observed regardless of the anchor used (both Group 1 and 2; P < .001).","['Sixty-nine patients', 'Arthroscopic Rotator Cuff Repair', 'patients with arthroscopic rotator cuff repair']","['open-construct (PEEK) (polyether ether ketone) suture anchor with those of a non-vented biocomposite suture anchor', 'Open-Construct PEEK Suture Anchor and Non-Vented Biocomposite Suture Anchor', 'Magnetic resonance imaging or ultrasonography', 'suture anchors used for rotator cuff repair; group 1: open-construct PEEK anchor (36 patients), group 2: non-vented biocomposite anchor']","['re-tear rate', 'American Shoulder and Elbow Surgeons score, Constant score, and visual analog scale score for pain and range of motion', 'bone ingrowth grades', 'functional scores and range of motion', 'shoulder function and pain relief', 'rate of cyst formation']","[{'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder (procedure)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C3540034', 'cui_str': 'Ethers'}, {'cui': 'C0022634', 'cui_str': 'Ketones'}, {'cui': 'C1720977', 'cui_str': 'Suture Anchors'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder (procedure)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",69.0,0.0388744,"RESULTS


Significant improvements in shoulder function and pain relief were observed regardless of the anchor used (both Group 1 and 2; P < .001).","[{'ForeName': 'Jong-Ho', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Wonkwang University Sanbon Hospital, Wonkwang University of School of Medicine, Gunpo, Gyeonggi-do, Korea.'}, {'ForeName': 'Yang-Soo', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': ""Department of Orthopedic Surgery, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'In', 'Initials': 'I', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, Ewha Womans University Seoul Hospital, Ewha Womans University, Seoul, Korea.'}, {'ForeName': 'Hyo-Jin', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': ""Department of Orthopedic Surgery, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Sang-Yup', 'Initials': 'SY', 'LastName': 'Han', 'Affiliation': ""Department of Orthopedic Surgery, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Sehoon', 'Initials': 'S', 'LastName': 'Jung', 'Affiliation': ""Department of Orthopedic Surgery, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Sang-Jin', 'Initials': 'SJ', 'LastName': 'Shin', 'Affiliation': 'Department of Orthopedic Surgery, Ewha Womans University Seoul Hospital, Ewha Womans University, Seoul, Korea. Electronic address: sjshin622@ewha.ac.kr.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2019.08.049']
252,32064639,"Combining whole-school and targeted programs for the reduction of bullying victimization: A randomized, effectiveness trial.","Despite the extensive evaluation of school-based interventions for bullying, victimization remains a significant problem in schools. Bullying victimization is significantly predicted by contextual (school-related) factors. As a consequence whole-school programs have been commonly used to prevent and reduce bullying victimization. Evidence also points to individual risk factors (such as emotional distress) in predicting victimization, yet programs to prevent bullying victimization by changing these individual risks are far less developed. Few studies have approximated ""real-world"" implementation conditions in their trials. The current effectiveness trial evaluated the combination of a whole-school program designed to prevent bullying perpetration and victimization together with a targeted intervention for at-risk students, teaching them individual and dyadic strategies to reduce their anxiety and manage victimization, allowing schools some latitude to implement programs as they typically would. Students from Grades 3 and 4 (N = 8,732) across 135 schools were randomly assigned to one of four conditions: combined intervention; whole-school intervention only; individual intervention only; and care as usual. Victimization decreased significantly and similarly across all four conditions at 12 and 24 months following baseline. Similar reductions and failure to discriminate conditions were found on other key constructs: anxiety; bullying perpetration; and depression. Possible reasons for the failure to demonstrate victimization prevention differences and lessons learned from this large, effectiveness trial are considered.",2020,Similar reductions and failure to discriminate conditions were found on other key constructs: anxiety; bullying perpetration; and depression.,"['Students from Grades 3 and 4 (N\u2009=\u20098,732) across 135 schools']",['combined intervention; whole-school intervention only; individual intervention only; and care as usual'],"['Bullying victimization', 'Victimization']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}]",,0.0274574,Similar reductions and failure to discriminate conditions were found on other key constructs: anxiety; bullying perpetration; and depression.,"[{'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Rapee', 'Affiliation': 'Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Shaw', 'Affiliation': 'Telethon Kids Institute, Perth, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hunt', 'Affiliation': 'School of Psychology, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Bussey', 'Affiliation': 'Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Hudson', 'Affiliation': 'Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': 'Deakin Health Economics, Centre for Population Health Research, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Edith Cowan University, Perth, Western Australia, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Radom', 'Affiliation': 'Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Cordin', 'Affiliation': 'Telethon Kids Institute, Perth, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Epstein', 'Affiliation': 'Telethon Kids Institute, Perth, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Cross', 'Affiliation': 'Telethon Kids Institute, Perth, Australia.'}]",Aggressive behavior,['10.1002/ab.21881']
253,31479082,Multidisciplinary Concussion Management: A Model for Outpatient Concussion Management in the Acute and Post-Acute Settings.,"OBJECTIVE


To describe a model of multidisciplinary concussion management and explore management methods in the acute and post-acute settings.
SETTING


A multidisciplinary concussion management program within a large health system.
PARTICIPANTS


Patients with sports and non-sports-related concussions aged 14 to 18 years with persisting concussion symptoms at 4 weeks postinjury or beyond.
DESIGN


Pilot randomized controlled trial comparing a subsymptom threshold exercise program with standard-of-care treatment in the post-acute setting.
MAIN MEASURES


Beck Depression Inventory-II and the Post-Concussion Scale-Revised.
RESULTS


Across groups, 60% improvement in concussion symptoms was noted. After removing the influence of depression, the intervention showed a large effect on symptom reduction, with participants in the intervention group improving more than those in the control group. There was no difference in response to the intervention by the sports and nonsports groups.
CONCLUSION


Results demonstrate that exercise intervention is effective in reducing symptoms in adolescents with persisting symptoms. The finding that participants in the control group who underwent education, light activity, and sophisticated monitoring still had meaningful recovery supports the utility of active engagement in a multidisciplinary management program. Finally, depression had a clinically meaningful effect on recovery, highlighting the need for targeted intervention of noninjury factors relevant to persisting symptoms.",2019,"After removing the influence of depression, the intervention showed a large effect on symptom reduction, with participants in the intervention group improving more than those in the control group.","['adolescents with persisting symptoms', 'Patients with sports and non-sports-related concussions aged 14 to 18 years with persisting concussion symptoms at 4 weeks postinjury or beyond']","['exercise intervention', 'subsymptom threshold exercise program with standard-of-care treatment', 'Multidisciplinary Concussion Management']","['concussion symptoms', 'symptom reduction', 'Beck Depression Inventory-II and the Post-Concussion Scale-Revised']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0006107', 'cui_str': 'Cerebral Concussion'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0006107', 'cui_str': 'Cerebral Concussion'}]","[{'cui': 'C0006107', 'cui_str': 'Cerebral Concussion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0222045'}]",,0.0496423,"After removing the influence of depression, the intervention showed a large effect on symptom reduction, with participants in the intervention group improving more than those in the control group.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bailey', 'Affiliation': 'Departments of Neurology (Drs Bailey and Meyer), Pediatrics (Dr Briskin), Medicine (Dr Tangen), Neurosurgery (Dr Hoffer), and Rehabilitation Services (Messrs Dundr and Smith and Dr Brennan), University Hospitals Cleveland Medical Center, Cleveland, Ohio; and School of Medicine, Case Western Reserve University, Cleveland, Ohio (Drs Bailey, Meyer, Briskin, and Hoffer).'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Meyer', 'Affiliation': ''}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Briskin', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Tangen', 'Affiliation': ''}, {'ForeName': 'S Alan', 'Initials': 'SA', 'LastName': 'Hoffer', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Dundr', 'Affiliation': ''}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Brennan', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000527']
254,32265143,"Optical enhancement imaging versus acetic acid for detecting gastric intestinal metaplasia: A randomized, comparative trial.","BACKGROUND AND AIMS


The diagnosis of gastric intestinal metaplasia (GIM) is still challenging. Optical Enhancement technology (OE) may improve the detection of GIM. We compared detection of GIM with OE, acetic acid and the Sydney biopsy protocol in a surveillance population.
METHODS


Consecutive patients with atrophic gastritis or known GIM were prospectively included. The stomach was examined with high definition whitelight endoscopy, followed by OE or acetic acid with targeted biopsies (1:1 randomisation). Subsequently, five random biopsies were taken according to the updated Sydney system.
RESULTS


A total of 154 patients were randomized. Higher proportions of patients with GIM were detected by OE and acetic acid versus random biopsy (60.5% vs 35.5%, 67.1% vs 31.5%, respectively; P < 0.0001 for both comparisons). The combined use of targeted biopsies and random biopsies provides high diagnostic yields for GIM (78.9% in OE group and 83.6% in acetic acid group). In addition, the proportion of extensive GIM was significantly increased when image enhanced endoscopy was used instead of white light endoscopy (P = 0.029, P = 0.048, respectively).
CONCLUSIONS


OE and acetic acid showed comparable results diagnosing GIM in the study. Targeted biopsies plus random biopsies should be used complementary in high risk populations.",2020,"In addition, the proportion of extensive GIM was significantly increased when image enhanced endoscopy was used instead of white light endoscopy (P = 0.029, P = 0.048, respectively).
","['Consecutive patients with atrophic gastritis or known GIM were prospectively included', '154 patients were randomized', 'gastric intestinal metaplasia']","['OE and acetic acid', 'Optical enhancement imaging versus acetic acid', 'GIM with OE, acetic acid and the Sydney biopsy protocol', 'Optical Enhancement technology (OE']",['proportion of extensive GIM'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017154', 'cui_str': 'Atrophic gastritis'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0267187', 'cui_str': 'Intestinal metaplasia of gastric mucosa'}]","[{'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0969683', 'cui_str': 'Enhancement Technologies'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive'}]",154.0,0.122132,"In addition, the proportion of extensive GIM was significantly increased when image enhanced endoscopy was used instead of white light endoscopy (P = 0.029, P = 0.048, respectively).
","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ji', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Ming-Ming', 'Initials': 'MM', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Yue-Yue', 'Initials': 'YY', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Xiu-Li', 'Initials': 'XL', 'LastName': 'Zuo', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Pathology, Qilu Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Yan-Qing', 'Initials': 'YQ', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, China. Electronic address: liyanqing@sdu.edu.cn.'}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2020.02.010']
255,31977370,Investigating the Effect of Perioperative Chlorzoxazone on Acute Postoperative Pain After Total Hip and Knee Replacement Surgery.,"BACKGROUND AND AIMS


Severe preoperative and acute postoperative pain have been associated with the development of chronic postoperative pain. Chlorzoxazone (a muscle relaxant) has been suggested to enhance acute postoperative pain recovery, but the lack of larger randomized controlled trials has, however, questioned the continued use. Despite this, chlorzoxazone is still used for acute postoperative pain management following total knee replacement (TKR) or total hip replacement (THR). The current randomized, double-blinded, placebo-controlled, parallel-group, clinical trial aimed to assess the effect of chlorzoxazone for postoperative pain management following TKR or THR.
METHODS


A total of 393 patients scheduled for TKR or THR were included in the trial. Patients were assigned to 250 mg chlorzoxazone 3 times daily for the first 7 days postoperatively or to placebo. The primary outcome was pain after 5 m walk assessed 24 hours postoperatively. Secondary outcomes included changes in preoperative pain at rest, worst pain in the last 24 hours, and Oxford Knee or Hip Score compared with 12 months' follow-up. In addition, adverse events were assessed in the perioperative period.
RESULTS


No significant differences were found for any of the outcome parameters after TKR or THR. As regards TKR or THR, no effects were demonstrated for pain after 5 m walk 24 hours after surgery (P>0.313), or for any of the secondary outcomes (P>0.288) or adverse events (P>0.112) in the group receiving chlorzoxazone compared with placebo.
CONCLUSION


The current study demonstrated no analgesic effects of postoperative chlorzoxazone administration compared with placebo on acute or chronic postoperative pain 12 months following TKR and THR.",2020,"For neither TKR or THR no effects were demonstrated for pain after 5 meters walk 24-hours after surgery (P>0.313), or for any of the secondary outcomes (P>0.288) or adverse event (P>0.112) in the group receiving chlorzoxazone compared with placebo.
","['393 patients scheduled for TKR or THR were included in the trial', 'total knee or hip replacement (TKR or THR']","['Perioperative Chlorzoxazone', 'Chlorzoxazone (a muscle relaxant', 'Total Hip and Knee Replacement Surgery', 'placebo', 'postoperative chlorzoxazone', 'chlorzoxazone']","['Acute Postoperative Pain', 'pain after 5 meter walk assessed 24-hours postoperative', 'changes in preoperative pain at rest, worst pain in the last 24 hours, and Oxford Knee or Hip Score', 'adverse events', 'pain']","[{'cui': 'C4517754', 'cui_str': 'Three hundred and ninety-three'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0392806', 'cui_str': 'Hip Prosthesis Implantation'}]","[{'cui': 'C0008296', 'cui_str': 'Chlorzoxazone'}, {'cui': 'C0026827', 'cui_str': 'Hypomyotonia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C2215257', 'cui_str': 'Acute postoperative pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",393.0,0.392546,"For neither TKR or THR no effects were demonstrated for pain after 5 meters walk 24-hours after surgery (P>0.313), or for any of the secondary outcomes (P>0.288) or adverse event (P>0.112) in the group receiving chlorzoxazone compared with placebo.
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Skrejborg', 'Affiliation': 'Department of Health Science and Technology, Center for Sensory-Motor Interaction (SMI).'}, {'ForeName': 'Kristian K', 'Initials': 'KK', 'LastName': 'Petersen', 'Affiliation': 'Department of Health Science and Technology, Center for Sensory-Motor Interaction (SMI).'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Beck', 'Affiliation': 'Orthopaedic Research Unit.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ulrich', 'Affiliation': 'Orthopaedic Research Unit.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Simonsen', 'Affiliation': 'Orthopaedic Research Unit.'}, {'ForeName': 'Poul T', 'Initials': 'PT', 'LastName': 'Nielsen', 'Affiliation': 'Orthopaedic Research Unit.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Arendt-Nielsen', 'Affiliation': 'Department of Health Science and Technology, Center for Sensory-Motor Interaction (SMI).'}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Laursen', 'Affiliation': 'Orthopaedic Research Unit.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000805']
256,32100888,Relations between forms and functions of aggression and moral judgments of aggressive transgressions.,"The present study sought to examine the influence of aggressive behavior, psychopathy, and gender on moral judgments of aggressive transgressions. A two-dimensional conceptualization of aggression was used, such that proactive relational aggression, reactive relational aggression, proactive physical aggression, and reactive physical aggression were treated as distinct subtypes of aggression and also as distinct subtypes of moral judgments of aggression. Participants were 421 emerging adults (215 women). Self-report measures of aggression, psychopathy, and moral judgments were collected. Peer-reports of aggression and psychopathy were obtained from a randomly assigned subsample of 73 participants (46 women) for validity purposes. Unique associations were found between subtypes of aggression and corresponding moral judgments of the same subtypes.",2020,Unique associations were found between subtypes of aggression and corresponding moral judgments of the same subtypes.,"['Participants were 421 emerging adults (215 women', '73 participants (46 women) for validity purposes']",[],"['proactive relational aggression, reactive relational aggression, proactive physical aggression, and reactive physical aggression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}]",[],"[{'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0424323', 'cui_str': 'Physical aggression (finding)'}]",421.0,0.0275516,Unique associations were found between subtypes of aggression and corresponding moral judgments of the same subtypes.,"[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Hart', 'Affiliation': 'University at Buffalo, The State University of New York, Buffalo, New York.'}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Ostrov', 'Affiliation': 'University at Buffalo, The State University of New York, Buffalo, New York.'}]",Aggressive behavior,['10.1002/ab.21883']
257,32246798,A Novel DBS Paradigm for Axial Features in Parkinson's Disease: A Randomized Crossover Study.,"BACKGROUND


High-frequency (130-185 Hz) deep brain stimulation (DBS) of the subthalamic nucleus is more effective for appendicular than axial symptoms in Parkinson's disease (PD). Low-frequency (60-80 Hz) stimulation (LFS) may reduce gait/balance impairment but typically results in worsening appendicular symptoms. We created a ""dual-frequency"" programming paradigm (interleave-interlink, IL-IL) to address both axial and appendicular symptoms. In IL-IL, 2 overlapping LFS programs are applied to the DBS lead, with the overlapping area focused on the optimal cathode. The nonoverlapping area (LFS) is thought to reduce gait/balance impairment, whereas the overlapping area (high-frequency stimulation, HFS) aims to control appendicular symptoms.
METHODS


We performed a randomized, double-blind crossover trial comparing patients' previously optimized IL-IL and conventional HFS paradigms. Each arm was 2 weeks in duration. The primary outcome measure was the patient/caregiver Modified Clinical Global Impression Severity (CGI-S). Secondary outcome measures included blinded motor evaluations, timed tests, patient/caregiver questionnaires, and Personal KinetiGraphs (PKG).
RESULTS


Twenty-five patients were enrolled, and 20 completed. The patient/caregiver CGI-S for gait/balance (P = 0.01) and appendicular symptom control (P = 0.001), and the blinded rater MDS-UPDRS-III (-5.22, P = 0.02), CGI-S gait/balance (P = 0.01), and CGI-S speech (P = 0.02) were better while on IL-IL. Scores on Parkinson's Disease Quality of Life (P = 0.002) and Freezing-of-Gait Questionnaires (P = 0.04) were better on IL-IL. The Timed-Up-and-Go was 9.8% faster (P = 0.01), with 11.8% reduction in steps (P = 0.001) on IL-IL. There was no difference in PKG bradykinesia (P = 0.18) or tremor (P = 0.23) between paradigms.
CONCLUSIONS


Our results prompt consideration of this novel programming paradigm (IL-IL) for PD patients with axial symptom impairment as a new treatment option for both axial and appendicular symptoms. © 2020 International Parkinson and Movement Disorder Society.",2020,Scores on Parkinson's Disease Quality of Life (P = 0.002) and Freezing-of-Gait Questionnaires (P = 0.04) were better on IL-IL.,"['Twenty-five patients were enrolled, and 20 completed', ""Parkinson's disease (PD"", ""Parkinson's Disease"", 'PD patients with axial symptom impairment', ""patients' previously optimized IL-IL and conventional HFS paradigms""]",['Low-frequency (60-80 Hz) stimulation (LFS'],"['Freezing-of-Gait Questionnaires', 'appendicular symptom control', 'CGI-S gait/balance', 'patient/caregiver Modified Clinical Global Impression Severity (CGI-S', 'blinded motor evaluations, timed tests, patient/caregiver questionnaires, and Personal KinetiGraphs (PKG', 'PKG bradykinesia', 'blinded rater MDS-UPDRS-III', ""Scores on Parkinson's Disease Quality of Life"", 'CGI-S speech']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C2745948', 'cui_str': 'Juvenile hyaline fibromatosis'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0085390', 'cui_str': 'Li-Fraumeni syndrome'}]","[{'cui': 'C0860515', 'cui_str': 'Freezing of gait'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0010536', 'cui_str': 'Cyclic GMP-Dependent Protein Kinase'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}, {'cui': 'C0265219', 'cui_str': 'Miller Dieker syndrome'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]",25.0,0.356047,Scores on Parkinson's Disease Quality of Life (P = 0.002) and Freezing-of-Gait Questionnaires (P = 0.04) were better on IL-IL.,"[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Karl', 'Affiliation': 'Movement Disorder Section of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Bichun', 'Initials': 'B', 'LastName': 'Ouyang', 'Affiliation': 'Movement Disorder Section of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Goetz', 'Affiliation': 'Medtronic Brain Modulation, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Leo Verhagen', 'Initials': 'LV', 'LastName': 'Metman', 'Affiliation': 'Movement Disorder Section of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28048']
258,30952918,"Randomized, Double-blind, Placebo-controlled Study of a Multispecies Probiotic Mixture in Nonalcoholic Fatty Liver Disease.","The intestinal microbiota is closely associated with the development of obesity and nonalcoholic fatty liver disease (NAFLD). This study investigated the effects of probiotic treatment on visceral fat area (VFA) and intrahepatic fat (IHF) fraction in NAFLD. Sixty-eight obese NAFLD patients (>5% proton density fat fraction [PDFF] on magnetic resonance imaging [MRI]) were randomized to probiotic and placebo groups for 12 weeks. The probiotic mixture included 6 bacterial species. VFA and IHF were measured using the MRI-PDFF technique. Body weight and total body fat were reduced in the probiotic group but not in the placebo group. The mean IHF fraction was reduced after 12 weeks of treatment in the probiotic group compared to that at baseline (from 16.3 ± 15.0% to 14.1 ± 7.7%, p = 0.032) but was not reduced in the placebo group. The decrease in IHF (mean difference: -2.61%, p = 0.012) was also greater in the probiotic group than in the placebo group. Reduction of triglyceride was greater in the probiotic treatment group than in the placebo group (mean difference: -34.0 mg/dl, p = 0.0033). However, the changes in IHF percentage and triglyceride levels were not different between placebo and control groups after adjusting for changes in body weight. Treatment with probiotics for 12 weeks resulted in significant reduction in IHF and body weight in obese NAFLD patients.",2019,"The decrease in IHF (mean difference: -2.61%, p = 0.012) was also greater in the probiotic group than in the placebo group.","['Sixty-eight obese NAFLD patients (>5% proton density fat fraction [PDFF] on magnetic resonance imaging [MRI', 'obese NAFLD patients', 'Nonalcoholic Fatty Liver Disease']","['Multispecies Probiotic Mixture', 'placebo', 'Placebo', 'probiotic and placebo', 'probiotic treatment']","['IHF and body weight', 'IHF', 'mean IHF fraction', 'IHF percentage and triglyceride levels', 'visceral fat area (VFA) and intrahepatic fat (IHF) fraction', 'VFA and IHF', 'Reduction of triglyceride', 'Body weight and total body fat']","[{'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0033727', 'cui_str': 'Hydrogen Ions'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0424677', 'cui_str': 'Total body fat (observable entity)'}]",68.0,0.192723,"The decrease in IHF (mean difference: -2.61%, p = 0.012) was also greater in the probiotic group than in the placebo group.","[{'ForeName': 'Sang Bong', 'Initials': 'SB', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Eulji University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Dae Won', 'Initials': 'DW', 'LastName': 'Jun', 'Affiliation': 'Department of Internal Medicine, Hanyang University School of Medicine, Hanyang University Medical Center, Seoul, Korea. noshin@hanyang.ac.kr.'}, {'ForeName': 'Bo-Kyeong', 'Initials': 'BK', 'LastName': 'Kang', 'Affiliation': 'Department of Radiology, Hanyang University School of Medicine, Hanyang University Medical Center, Seoul, Korea. dr.bokyeong.kang@gmail.com.'}, {'ForeName': 'Jong Hyun', 'Initials': 'JH', 'LastName': 'Lim', 'Affiliation': 'R&D center Microbiome, Cell Biotech, Gyeongi, Korea.'}, {'ForeName': 'Sanghyun', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'R&D center Microbiome, Cell Biotech, Gyeongi, Korea.'}, {'ForeName': 'Myung-Jun', 'Initials': 'MJ', 'LastName': 'Chung', 'Affiliation': 'R&D center Microbiome, Cell Biotech, Gyeongi, Korea.'}]",Scientific reports,['10.1038/s41598-019-42059-3']
259,30952920,Periocular skin warming elevates the distal skin temperature without affecting the proximal or core body temperature.,"Periocular skin warming reportedly improves the objective and subjective sleep quality in adults with mild difficulty in falling asleep. To clarify the effects of periocular warming, we examined the distal skin temperatures (hands and feet), proximal skin temperature (infraclavicular region) and core body temperature as well as the distal-proximal skin temperature gradient (DPG). Nineteen healthy males underwent two experimental sessions, wherein they used a warming or sham eye mask under a semi-constant routine protocol in a crossover manner. Participants were instructed to maintain wakefulness with their eyes closed for 60 minutes after wearing the eye mask. The warming eye mask increased the periocular skin temperature to 38-40 °C for the first 20 minutes, whereas the temperature remained unchanged with the sham mask. Compared to that of the sham eye mask, the warming eye mask significantly increased the temperatures of the hands and feet and the DPG, whereas the proximal skin and core body temperatures were unaffected. Subjective sleepiness and pleasantness were significantly increased by the warming eye mask. These results represent physiological heat loss associated with sleep initiation without affecting the proximal skin or core body temperatures, suggesting that thermal stimulation in certain areas can provoke similar changes in remote areas of the body.",2019,Periocular skin warming reportedly improves the objective and subjective sleep quality in adults with mild difficulty in falling asleep.,"['adults with mild difficulty in falling asleep', 'Nineteen healthy males']",['warming or sham eye mask under a semi-constant routine protocol'],"['objective and subjective sleep quality', 'periocular skin temperature', 'distal skin temperature', 'Subjective sleepiness and pleasantness', 'temperatures of the hands and feet and the DPG', 'proximal skin and core body temperatures', 'distal skin temperatures (hands and feet), proximal skin temperature (infraclavicular region) and core body temperature as well as the distal-proximal skin temperature gradient (DPG']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0181752', 'cui_str': 'Eye mask (physical object)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0456240', 'cui_str': 'Core body temperature (observable entity)'}, {'cui': 'C0230108', 'cui_str': 'Infraclavicular region structure'}]",19.0,0.0152693,Periocular skin warming reportedly improves the objective and subjective sleep quality in adults with mild difficulty in falling asleep.,"[{'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Ichiba', 'Affiliation': 'Personal Health Care Laboratory, Kao Corporation, 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan. ichiba.tomohisa@kao.com.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Psychiatry, Nihon University School of Medicine, 30-1, Oyaguchi Kamicho, Itabashi-ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Aritake-Okada', 'Affiliation': 'Faculty of Health and Social Services, Saitama Prefectural University, 820, Sannomiya, Koshigaya, Saitama, 343-8540, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Psychiatry, Nihon University School of Medicine, 30-1, Oyaguchi Kamicho, Itabashi-ku, Tokyo, 173-8610, Japan. uchiyama.makoto@nihon-u.ac.jp.'}]",Scientific reports,['10.1038/s41598-019-42116-x']
260,31058705,Exploring the Mechanism of Effectiveness of a Psychoeducational Intervention in a Rehabilitation Program (CopenHeartRFA) for Patients Treated With Ablation for Atrial Fibrillation: A Mixed Methods Study.,"BACKGROUND


Patients treated for atrial fibrillation with an ablation can experience decreased mental health. Little is known about the effect of a psychoeducation intervention on this patient group.
OBJECTIVES


The aim of this study was to explore the effect of a psychoeducation intervention on patients' mental health after participating in a cardiac rehabilitation program, with a focus on elaborating on the lack of mental health improvements.
METHOD


Sequential explanatory mixed methods including secondary analysis of qualitative and quantitative data collected in a randomized rehabilitation trial was performed. Perceived health was measured by a questionnaire (n = 95), and qualitative interviews were performed (n = 10).
RESULTS


Patients scoring high on perceived health experienced positive effects of the intervention. Patients scoring low appear to have either low physical capacity and severe atrial fibrillation symptoms, bigger life issues, or lack of social support.
CONCLUSION


A more in-depth understanding of the effect of a psychoeducational intervention included in a cardiac rehabilitation program has been achieved.",2019,"RESULTS


Patients scoring high on perceived health experienced positive effects of the intervention.","['Patients Treated With Ablation for Atrial Fibrillation', ""patients' mental health after participating in a cardiac rehabilitation program, with a focus on elaborating on the lack of mental health improvements""]","['psychoeducational intervention', 'Psychoeducational Intervention', 'psychoeducation intervention', 'Rehabilitation Program (CopenHeartRFA']","['mental health', 'Perceived health', 'low physical capacity and severe atrial fibrillation symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}]","[{'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",95.0,0.039938,"RESULTS


Patients scoring high on perceived health experienced positive effects of the intervention.","[{'ForeName': 'Signe Stelling', 'Initials': 'SS', 'LastName': 'Risom', 'Affiliation': 'Signe Stelling Risom, RN, MSc, PhD Clinical Nurse Specialist and Associate Professor, Rigshospitalet, Centre for Cardiac, Vascular, Pulmonary and Infectious Diseases, Copenhagen University Hospital, and Institute of Nursing, University College Copenhagen, Denmark. Johanne Lind, RN, MA, MPH Associate Professor, Institute of Nursing, University College Copenhagen, Denmark. Victoria Vaughan Dickson, RN, PhD Associate Professor, Rory Meyers College of Nursing, New York University. Selina Kikkenborg Berg, RN, MScN, PhD Professor and Senior Researcher, Rigshospitalet, Centre for Cardiac, Vascular, Pulmonary and Infectious Diseases, Copenhagen University Hospital; Faculty of Health and Medical Sciences, University of Copenhagen; and National Institute of Public Health, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Lind', 'Affiliation': ''}, {'ForeName': 'Victoria Vaughan', 'Initials': 'VV', 'LastName': 'Dickson', 'Affiliation': ''}, {'ForeName': 'Selina Kikkenborg', 'Initials': 'SK', 'LastName': 'Berg', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000584']
261,30920439,Motivational Counseling to Reduce Sedentary Behaviors and Depressive Symptoms and Improve Health-Related Quality of Life Among Women With Metabolic Syndrome.,"BACKGROUND


Motivational interviewing, as a counseling approach, could promote not only behavioral changes but also individuals' psychological adaptation. Previous studies provide evidence that motivational interviewing focused on increasing physical activity decreases the risk of metabolic syndrome in women. Its effects on sedentary behaviors, depressive symptoms, and health-related quality of life (HRQL) remain unknown.
OBJECTIVES


The aim of this study was to evaluate whether a 12-week motivational counseling program reduces sedentary behaviors and depressive symptoms and improves HRQL in Taiwanese women.
METHODS


A randomized controlled study was conducted. Participants (n = 115) were randomly assigned into 3 groups: experimental group (received a brochure on lifestyle modification combined with 12 weeks of motivational counseling), comparison group (received a lifestyle modification brochure), and usual care group (UCG). Outcome variables were measured at baseline and at 12 weeks post intervention by the International Physical Activity Questionnaire, Beck Depression Inventory, and Medical Outcomes Short Form-36 Health Survey. Generalized estimating equations were applied to analyze the intervention effects of groups by interaction of group and time.
RESULTS


Women in the experimental group not only reduced (P < .001) weekly sitting time by 374 minutes but also decreased (P < .05) depressive symptoms, as well as had greater overall HRQL including 8 subscales as compared with the UCG. As compared with the UCG, the women in the comparison group had no change in sedentary behaviors, but they had reduced depressive symptoms and improvement on some HRQL subscales.
CONCLUSIONS


Motivational counseling that incorporates behavioral change principles is effective in reducing sedentary behaviors and depressive symptoms and improving HRQL for women with metabolic syndrome.",2019,"RESULTS


Women in the experimental group not only reduced (P < .001) weekly sitting time by 374 minutes but also decreased (P < .05) depressive symptoms, as well as had greater overall HRQL including 8 subscales as compared with the UCG.","['women', 'Women With Metabolic Syndrome', 'women with metabolic syndrome', 'Participants (n = 115', 'Taiwanese women']","['motivational counseling program', 'brochure on lifestyle modification combined with 12 weeks of motivational counseling), comparison group (received a lifestyle modification brochure), and usual care group (UCG', 'Motivational counseling', 'Motivational Counseling']","['sedentary behaviors and depressive symptoms', 'overall HRQL', 'sedentary behaviors', 'International Physical Activity Questionnaire, Beck Depression Inventory, and Medical Outcomes Short Form-36 Health Survey', 'sedentary behaviors, depressive symptoms, and health-related quality of life (HRQL', 'Sedentary Behaviors and Depressive Symptoms and Improve Health-Related Quality of Life', 'depressive symptoms', 'sitting time', 'HRQL subscales']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C1556096', 'cui_str': 'Taiwanese (ethnic group)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",115.0,0.0882138,"RESULTS


Women in the experimental group not only reduced (P < .001) weekly sitting time by 374 minutes but also decreased (P < .05) depressive symptoms, as well as had greater overall HRQL including 8 subscales as compared with the UCG.","[{'ForeName': 'Li-Chi', 'Initials': 'LC', 'LastName': 'Chiang', 'Affiliation': 'Li-Chi Chiang, PhD, RN Professor, School of Nursing, China Medical University, Taichung; and School of Nursing & Graduate Institute of Medical Science, National Defense Medical Center, Taipei, Taiwan, R.O.C. Margaret McLean Heitkemper, PhD, RN, FAAN Professor and Chairperson, Department of Biobehavioral Nursing and Health Systems, and Adjunct Professor, Division of Gastroenterology, School of Medicine, University of Washington, Seattle. Shang-Lin Chiang, MD, PhD Assistant Professor, School of Medicine, National Defense Medical Center; and Director, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, Taipei, Taiwan, ROC. Wen-Chii Tzeng, PhD, RN Associate Professor, School of Nursing, National Defense Medical Center, Taipei, Taiwan, R.O.C. Meei-Shyuan Lee, PhD Professor, School of Public Health & Graduate Institute of Medical Science, National Defense Medical Center, Taipei, Taiwan, R.O.C. Yi-Jen Hung, MD Professor, School of Medicine, National Defense Medical Center; and Superintendent, Songshan Branch of Tri-Service General Hospital, Taipei, Taiwan, R.O.C. Chia-Huei Lin, PhD, RN Assistant Professor, Schools of Nursing and Medicine, National Defense Medical Center; and Supervisor, Department of Nursing, Songshan Branch of Tri-Service General Hospital, Taipei, Taiwan, R.O.C.'}, {'ForeName': 'Margaret McLean', 'Initials': 'MM', 'LastName': 'Heitkemper', 'Affiliation': ''}, {'ForeName': 'Shang-Lin', 'Initials': 'SL', 'LastName': 'Chiang', 'Affiliation': ''}, {'ForeName': 'Wen-Chii', 'Initials': 'WC', 'LastName': 'Tzeng', 'Affiliation': ''}, {'ForeName': 'Meei-Shyuan', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Yi-Jen', 'Initials': 'YJ', 'LastName': 'Hung', 'Affiliation': ''}, {'ForeName': 'Chia-Huei', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000573']
262,30890061,Maternal health outcomes among HIV-infected breastfeeding women with high CD4 counts: results of a treatment strategy trial.,"BACKGROUND


IMPAACT PROMISE 1077BF/FF was a randomized study of antiretroviral therapy (ART) strategies for pregnant and postpartum women with high CD4+ T-cell counts. We describe postpartum outcomes for women in the study who were randomized to continue or discontinue ART after delivery.
METHODS


Women with pre-ART CD4+ cell counts ≥350 cells/mm 3  who started ART during pregnancy were randomized postpartum to continue or discontinue treatment. Women were enrolled from India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe. The primary outcome was a composite of progression to AIDS-defining illness or death. Log-rank tests and Cox regression models assessed treatment effects. Incidence rates were calculated per 100 person-years. A post hoc analysis evaluated WHO Stage 2/3 events. All analyses were intent-to-treat.
FINDINGS


1611 women were enrolled (June 2011-October 2014) and 95% were breastfeeding. Median age at entry was 27 years, CD4+ count 728 cells/mm 3  and the majority of women were Black African (97%). After a median follow-up of 1.6 years, progression to AIDS-defining illness or death was rare and there was no significant difference between arms (HR: 0·55; 95%CI 0·14, 2·08, p = 0.37). WHO Stage 2/3 events were reduced with continued ART (HR: 0·60; 95%CI 0·39, 0·90, p = 0.01). The arms did not differ with respect to the rate of grade 2, 3, or 4 safety events (p = 0.61).
INTERPRETATION


Serious clinical events were rare among predominately breastfeeding women with high CD4+ cell counts over 18 months after delivery. ART had significant benefit in reducing WHO 2/3 events in this population.",2018,"The arms did not differ with respect to the rate of grade 2, 3, or 4 safety events (p = 0.61).
","['1611', 'pregnant and postpartum women with high CD4+ T-cell counts', 'Women with pre-ART CD4+ cell counts ≥350\xa0cells', 'HIV-infected breastfeeding women with high CD4 counts', 'women were enrolled (June 2011-October 2014) and 95% were breastfeeding', 'women in the study who were randomized to continue or discontinue ART after delivery', 'Women were enrolled from India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe', 'Median age at entry was 27\xa0years, CD4+ count 728\xa0cells/mm 3  and the majority of women were Black African (97']","['continued ART (HR', 'antiretroviral therapy (ART']","['Maternal health outcomes', 'progression to AIDS-defining illness or death', 'Incidence rates', 'composite of progression to AIDS-defining illness or death']","[{'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337824', 'cui_str': 'Black African (ethnic group)'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",1611.0,0.405132,"The arms did not differ with respect to the rate of grade 2, 3, or 4 safety events (p = 0.61).
","[{'ForeName': 'Risa M', 'Initials': 'RM', 'LastName': 'Hoffman', 'Affiliation': 'a Division of Infectious Diseases, Department of Medicine , David Geffen School of Medicine at the University of California, Los Angeles , Los Angeles , CA , USA.'}, {'ForeName': 'Konstantia Nadia', 'Initials': 'KN', 'LastName': 'Angelidou', 'Affiliation': 'b Center for Biostatistics in AIDS Research , Harvard T.H. Chan School of Public Health , Boston , MA , USA.'}, {'ForeName': 'Sean S', 'Initials': 'SS', 'LastName': 'Brummel', 'Affiliation': 'b Center for Biostatistics in AIDS Research , Harvard T.H. Chan School of Public Health , Boston , MA , USA.'}, {'ForeName': 'Friday', 'Initials': 'F', 'LastName': 'Saidi', 'Affiliation': 'c University of North Carolina Project-Malawi , Lilongwe , Malawi.'}, {'ForeName': 'Avy', 'Initials': 'A', 'LastName': 'Violari', 'Affiliation': 'd Perinatal HIV Research Unit , Chris Hani Baragwanath Hospital , Soweto , South Africa.'}, {'ForeName': 'Dingase', 'Initials': 'D', 'LastName': 'Dula', 'Affiliation': 'e Malawi College of Medicine , Johns Hopkins Project , Chichiri , Malawi.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Mave', 'Affiliation': 'f BJGMC Clinical Trials Unit , Pune , India.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'h Wits Reproductive Health and HIV Institute , Johannesburg , South Africa.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Theron', 'Affiliation': 'i Stellenbosch University , Cape Town , South Africa.'}, {'ForeName': 'Moreen', 'Initials': 'M', 'LastName': 'Kamateeka', 'Affiliation': 'j Makerere University, Johns Hopkins University Research Collaboration , Mulago Kampala , Uganda.'}, {'ForeName': 'Tsungai', 'Initials': 'T', 'LastName': 'Chipato', 'Affiliation': 'k Department of Obstetrics and Gynecology , University of Zimbabwe , Harare , Zimbabwe.'}, {'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Chi', 'Affiliation': 'l Department of Obstetrics and Gynecology , University of North Carolina School of Medicine , Chapel Hill , NC , USA.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Stranix-Chibanda', 'Affiliation': 'm University of Zimbabwe , Harare , Zimbabwe.'}, {'ForeName': 'Teacler', 'Initials': 'T', 'LastName': 'Nematadzira', 'Affiliation': 'n University of Zimbabwe College of Health Sciences Clinical Trials Research Centre , Harare , Zimbabwe.'}, {'ForeName': 'Dhayendre', 'Initials': 'D', 'LastName': 'Moodley', 'Affiliation': 'o Centre for the AIDS Programme of Research in South Africa and School of Clinical Medicine , University of KwaZulu Natal , Durban , South Africa.'}, {'ForeName': 'Debika', 'Initials': 'D', 'LastName': 'Bhattacharya', 'Affiliation': 'a Division of Infectious Diseases, Department of Medicine , David Geffen School of Medicine at the University of California, Los Angeles , Los Angeles , CA , USA.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'f BJGMC Clinical Trials Unit , Pune , India.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Coletti', 'Affiliation': 'p Family Health International 360 , Durham , NC , USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'McIntyre', 'Affiliation': 'q Anova Health Institute , Johannesburg , South Africa.'}, {'ForeName': 'Karin L', 'Initials': 'KL', 'LastName': 'Klingman', 'Affiliation': 's Division of AIDS , National Institute of Allergy and Infectious Diseases National Institutes of Health , Bethesda , MD , USA.'}, {'ForeName': 'Nahida', 'Initials': 'N', 'LastName': 'Chakhtoura', 'Affiliation': 't Eunice Kennedy Shriver National Institute of Child Health and Human Development , National Institutes of Health , Bethesda , MD , USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Shapiro', 'Affiliation': 'b Center for Biostatistics in AIDS Research , Harvard T.H. Chan School of Public Health , Boston , MA , USA.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'u Department of Pathology , Johns Hopkins University School of Medicine , Baltimore , MD , USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'a Division of Infectious Diseases, Department of Medicine , David Geffen School of Medicine at the University of California, Los Angeles , Los Angeles , CA , USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",HIV clinical trials,['10.1080/15284336.2018.1537327']
263,31584838,"Yoga Improves Balance and Low-Back Pain, but Not Anxiety, in People with Parkinson's Disease.","Individuals with Parkinson's disease (PD) experience postural instability, low-back pain (LBP), and anxiety. These symptoms increase the risk of falls and decrease quality of life. Research shows yoga improves balance and decreases LBP and anxiety in healthy adults, but its effects in PD are poorly understood. All participants were part of a larger intervention study. Participants received pretest and posttest evaluations, including the Balance Evaluation Systems Test (BESTest), Beck Anxiety Inventory (BAI), and Revised Oswestry Disability Index (ROSW). Total scores for each measure, as well as individual balance system section scores from the BESTest (biomechanical constraints, stability limits/verticality, transitions/anticipatory, reactive, sensory orientation, and stability in gait) were compared within groups pre- to posttest. Participants in the yoga group (n = 13) completed a twice-weekly 12-week yoga interve n t i o n , whereas controls (n = 13) continued their usual routines for 12 weeks. Both the yoga (Z = -3.20, p = 0.001) and control (Z = -2.10, p = 0.040) groups improved on the BESTest total score. The control group showed no changes in individual balance systems, whereas the yoga group improved in stability limits/verticality (Z = -2.3, p = 0.020), transitions/ anticipatory (Z = -2.50, p = 0.010), reactive (Z = -2.70, p = 0.008), and sensory orientation (Z = -2.30, p = 0.020). ROSW decreased in the yoga group only (Z = -2.10, p = 0.030). BAI did not change in either group. Yoga is a nonpharmacological intervention that can improve balance and LBP in people with PD. This study demonstrated that yoga is feasible for people with PD, and participants reported high levels of enjoyment and intent to practice yoga after the study.",2020,"The control group showed no changes in individual balance systems, whereas the yoga group improved in stability limits/verticality ( Z  = -2.3,  p  = 0.020), transitions/anticipatory ( Z  = -2.50,  p  = 0.010), reactive ( Z  = -2.70,  p  = 0.008), and sensory orientation ( Z  = -2.30,  p  = 0.020).","['people with PD', 'healthy adults', ""People with Parkinson's Disease"", ""Individuals with Parkinson's disease (PD) experience postural instability, low-back pain (LBP), and anxiety""]",[],"['ROSW', 'Balance and Low-Back Pain', 'individual balance system section scores from the BESTest (biomechanical constraints, stability limits/verticality, transitions/anticipatory, reactive, sensory orientation, and stability in gait', 'BAI', 'Total scores', 'LBP and anxiety', 'individual balance systems', 'stability limits/verticality', 'sensory orientation', 'balance and LBP', 'Balance Evaluation Systems Test (BESTest), Beck Anxiety Inventory (BAI), and Revised Oswestry Disability Index (ROSW', 'risk of falls and decrease quality of life']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",[],"[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0034380'}]",,0.0287948,"The control group showed no changes in individual balance systems, whereas the yoga group improved in stability limits/verticality ( Z  = -2.3,  p  = 0.020), transitions/anticipatory ( Z  = -2.50,  p  = 0.010), reactive ( Z  = -2.70,  p  = 0.008), and sensory orientation ( Z  = -2.30,  p  = 0.020).","[{'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Myers', 'Affiliation': 'Department of Neurology, Washington University School of Medicine; formerly, Program in Physical Therapy, Washington University School of Medicine, St. Louis.'}, {'ForeName': 'Elinor C', 'Initials': 'EC', 'LastName': 'Harrison', 'Affiliation': 'Department of Neurology, Washington University School of Medicine; formerly, Program in Physical Therapy, Washington University School of Medicine, St. Louis.'}, {'ForeName': 'Kerri S', 'Initials': 'KS', 'LastName': 'Rawson', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine, St. Louis.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Horin', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine, St. Louis.'}, {'ForeName': 'Ellen N', 'Initials': 'EN', 'LastName': 'Sutter', 'Affiliation': 'Department of Rehabilitation Medicine, University of Minnesota, Minneapolis; formerly, Program in Physical Therapy, Washington University School of Medicine, St. Louis.'}, {'ForeName': 'Marie E', 'Initials': 'ME', 'LastName': 'McNeely', 'Affiliation': 'Unfold Productions, LLC, St. Louis; formerly, Program in Physical Therapy, Washington University School of Medicine, and Department of Neurology, Washington University School of Medicine, St. Louis.'}, {'ForeName': 'Gammon M', 'Initials': 'GM', 'LastName': 'Earhart', 'Affiliation': 'Program in Physical Therapy; Department of Neurology; and Department of Neuroscience, Washington University School of Medicine, St. Louis.'}]",International journal of yoga therapy,['10.17761/2020-D-18-00028']
264,31901395,"Prevention of Perioperative Hypothermia: A Prospective, Randomized, Controlled Trial of Bair Hugger Versus Inditherm in Patients Undergoing Elective Arthroscopic Shoulder Surgery.","PURPOSE


To determine if a clinically significant difference in the core body temperature (CBT) exists between the Bair Hugger (BH) and Inditherm (IT) warming devices in patients undergoing arthroscopic shoulder surgery.
METHODS


This was a parallel, 2-treatment, prospective, randomized, controlled trial conducted in patients undergoing elective arthroscopic shoulder surgery in the beach-chair position using room-temperature irrigation fluid. The BH was used as the indicative forced-air warming device, whereas the IT served as the indicative resistive heating system. By use of a minimal clinically significant difference of 0.6°C and standard deviation of 0.6°C, a power analysis showed that a sample size of 90 patients (45 per group) would be required. Patients fulfilling the inclusion criteria were recruited from the clinics of the senior authors. Anesthetic and surgical protocols were standardized. The intraoperative CBT was recorded every 5 minutes using a nasopharyngeal thermistor probe. Demographic data as well as the volume of irrigation fluid used were also noted.
RESULTS


A steady decline in the CBT was observed in both groups up to 30 minutes after induction of anesthesia. Beyond 30 minutes, the BH group showed a gradual increase in temperature whereas it continued to decline in the IT group. A statistically significant difference in the CBT was observed from 60 minutes onward (P = .025). This difference continued to increase up to 90 minutes (P < .001). At no time was a rise in the CBT observed in the IT group. At completion of the study and surgical procedure, 13 of 47 patients in the BH group and 32 of 44 patients in the IT group had hypothermia (P = .0002).
CONCLUSIONS


The CBT was statistically significantly better with the use of the BH compared with the IT mattress. However, the differences in the CBT did not reach the level of clinical significance of 0.6°C. Far fewer patients in the BH group had hypothermia at the end of surgery. Therefore, this study supports the use of the BH in elective arthroscopic shoulder surgery for the prevention of hypothermia.
LEVEL OF EVIDENCE


Level I.",2020,A statistically significant difference in the CBT was observed from 60 minutes onward (P = .025).,"['Perioperative Hypothermia', 'patients undergoing elective arthroscopic shoulder surgery in the beach-chair position using room-temperature irrigation fluid', 'Patients Undergoing Elective Arthroscopic Shoulder Surgery', 'Patients fulfilling the inclusion criteria were recruited from the clinics of the senior authors', 'patients undergoing arthroscopic shoulder surgery']","['Bair Hugger (BH) and Inditherm (IT) warming devices', 'Bair Hugger Versus Inditherm']","['CBT', 'intraoperative CBT', 'temperature', 'hypothermia']","[{'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2316745', 'cui_str': 'Deckchair position'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C2746010', 'cui_str': 'Irrigating solution'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C3812881', 'cui_str': 'Writer (occupation)'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}]",90.0,0.0370796,A statistically significant difference in the CBT was observed from 60 minutes onward (P = .025).,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ralte', 'Affiliation': 'The Royal Liverpool & Broadgreen University Hospitals NHS Foundation Trust, Liverpool, England. Electronic address: peter.ralte@gmail.com.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Mateu-Torres', 'Affiliation': 'The Royal Liverpool & Broadgreen University Hospitals NHS Foundation Trust, Liverpool, England.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Winton', 'Affiliation': 'The Royal Liverpool & Broadgreen University Hospitals NHS Foundation Trust, Liverpool, England.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Bardsley', 'Affiliation': 'The Royal Liverpool & Broadgreen University Hospitals NHS Foundation Trust, Liverpool, England.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': 'The Royal Liverpool & Broadgreen University Hospitals NHS Foundation Trust, Liverpool, England.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Kent', 'Affiliation': 'The Royal Liverpool & Broadgreen University Hospitals NHS Foundation Trust, Liverpool, England.'}, {'ForeName': 'Dhandapani', 'Initials': 'D', 'LastName': 'Sethuraman', 'Affiliation': 'The Royal Liverpool & Broadgreen University Hospitals NHS Foundation Trust, Liverpool, England.'}, {'ForeName': 'Inigo', 'Initials': 'I', 'LastName': 'Guisasola', 'Affiliation': 'The Royal Liverpool & Broadgreen University Hospitals NHS Foundation Trust, Liverpool, England.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2019.08.015']
265,32141709,"Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT).","OBJECTIVE


To compare standard (native tissue) repair with synthetic mesh inlays or mesh kits.
DESIGN


Randomised controlled trial.
SETTING


Thirty-three UK hospitals.
POPULATION


Women having surgery for recurrent prolapse.
METHODS


Women recruited using remote randomisation.
MAIN OUTCOME MEASURES


Prolapse symptoms, condition-specific quality-of-life and serious adverse effects.
RESULTS


A Mean Pelvic Organ Prolapse Symptom Score at 1 year was similar for each comparison (standard 6.6 versus mesh inlay 6.1, mean difference [MD] -0.41, 95% CI -2.92 to 2.11: standard 6.6 versus mesh kit 5.9, MD -1.21 , 95% CI -4.13 to 1.72) but the confidence intervals did not exclude a minimally important clinical difference. There was no evidence of difference in any other outcome measure at 1 or 2 years. Serious adverse events, excluding mesh exposure, were similar at 1 year (standard 7/55 [13%] versus mesh inlay 5/52 [10%], risk ratio [RR] 1.05 [0.66-1.68]: standard 3/25 [12%] versus mesh kit 3/46 [7%], RR 0.49 [0.11-2.16]). Cumulative mesh exposure rates over 2 years were 7/52 (13%) in the mesh inlay arm, of whom four women required surgical revision; and 4/46 in the mesh kit arm (9%), of whom two required surgical revision.
CONCLUSIONS


We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery. Although the sample size was too small to be conclusive, the results provide a substantive contribution to future meta-analysis.
TWEETABLE ABSTRACT


There is not enough evidence to support use of synthetic mesh inlay or mesh kits for repeat prolapse surgery.",2020,We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery.,"['Women having surgery for recurrent prolapse', 'women undergoing repeat prolapse surgery', 'Women recruited using remote randomisation', '33 UK hospitals', 'women having repeat anterior or posterior prolapse surgery']","['standard (native tissue) repair against synthetic mesh inlays or mesh kits', 'Mesh inlay, mesh kit or native tissue repair']","['Mean Pelvic Organ Prolapse Symptom Score', 'surgical revision', 'prolapse symptoms', 'Prolapse symptoms, condition specific quality-of-life and serious adverse effects', 'Cumulative mesh exposure rates']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",4.0,0.336306,We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery.,"[{'ForeName': 'Cma', 'Initials': 'C', 'LastName': 'Glazener', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Breeman', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hemming', 'Affiliation': 'Department of Obstetrics and Gynaecology, Aberdeen Royal Infirmary, Aberdeen, UK.'}, {'ForeName': 'K G', 'Initials': 'KG', 'LastName': 'Cooper', 'Affiliation': 'Department of Obstetrics and Gynaecology, Aberdeen Royal Infirmary, Aberdeen, UK.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Freeman', 'Affiliation': 'Department of Obstetrics and Gynaecology, Plymouth Hospitals NHS Trust, Plymouth, UK.'}, {'ForeName': 'Arb', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': ""St Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hagen', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Montgomery', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kilonzo', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Boyers', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'McPherson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Usher Institute of Population Health Sciences & Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'Reid', 'Affiliation': ""St Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16197']
266,31097732,Complexity-Based Measures of Heart Rate Dynamics in Older Adults Following Long- and Short-Term Tai Chi Training: Cross-sectional and Randomized Trial Studies.,"Measures characterizing the complexity of heart rate (HR) dynamics have been informative in predicting age- and disease-related decline in cardiovascular health, but few studies have evaluated whether mind-body exercise can impact HR complexity. This study evaluated the effects of long-term Tai Chi (TC) practice on the complexity of HR dynamics using an observational comparison of TC experts and age- and gender-matched TC-naïve individuals. Shorter-term effects of TC were assessed by randomly assigning TC-naïve participants to either TC group to receive six months of TC training or to a waitlist control group. 23 TC experts (age = 63.3 ± 8.0 y; 24.6 ± 12.0 y TC experience) and 52 TC-naïve (age = 64.3 ± 7.7 y) were enrolled. In cross-sectional analyses, TC experts had a higher overall complexity index (CI, p = 0.004) and higher entropy at multiple individual time scales (p < 0.05); these findings persisted in models accounting for age, gender, body mass index (BMI), and physical activity levels. Longitudinal changes in complexity index did not differ significantly following random assignment to six months of TC vs. a waitlist control; however, within the TC group, complexity at select time scales showed statistically non-significant trends toward increases. Our study supports that longer-term TC mind-body training may be associated with increased complexity of HR dynamics.",2019,"In cross-sectional analyses, TC experts had a higher overall complexity index (CI, p = 0.004) and higher entropy at multiple individual time scales (p < 0.05); these findings persisted in models accounting for age, gender, body mass index (BMI), and physical activity levels.","['23 TC experts (age\u2009=\u200963.3\u2009±\u20098.0\u2009y; 24.6\u2009±\u200912.0\u2009y TC experience) and 52 TC-naïve (age\u2009=\u200964.3\u2009±\u20097.7\u2009y) were enrolled', 'Older Adults', 'TC experts and age- and gender-matched TC-naïve individuals']","['TC', 'TC training', 'long-term Tai Chi (TC) practice']","['complexity of heart rate (HR) dynamics', 'overall complexity index', 'body mass index (BMI), and physical activity levels', 'complexity index']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0148747,"In cross-sectional analyses, TC experts had a higher overall complexity index (CI, p = 0.004) and higher entropy at multiple individual time scales (p < 0.05); these findings persisted in models accounting for age, gender, body mass index (BMI), and physical activity levels.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Division of Interdisciplinary Medicine and Biotechnology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States. dr.yan.ma@gmail.com.'}, {'ForeName': 'Chiu-Wen', 'Initials': 'CW', 'LastName': 'Wu', 'Affiliation': 'National Taiwan Normal University, Department of Mechatronic Engineering, Taipei, Taiwan.'}, {'ForeName': 'Chung-Kang', 'Initials': 'CK', 'LastName': 'Peng', 'Affiliation': 'Division of Interdisciplinary Medicine and Biotechnology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ahn', 'Affiliation': 'Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Bertisch', 'Affiliation': 'Department of Pulmonary, Critical Care, and Sleep Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': 'Division of Gerontology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': 'Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Manor', 'Affiliation': 'Division of Gerontology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Novak', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Hausdorff', 'Affiliation': 'Center for the Study of Movement, Cognition, and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Gow', 'Affiliation': 'Division of Interdisciplinary Medicine and Biotechnology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Osher Center for Integrative Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}]",Scientific reports,['10.1038/s41598-019-43602-y']
267,32228534,"Enhancing communication, informed consent and recruitment in a paediatric urgent care surgical trial: a qualitative study.","BACKGROUND


Recruiting patients to paediatric trials can be challenging, especially in trials that compare markedly different management pathways and are conducted in acute settings. We aimed to enhance informed consent and recruitment in the CONTRACT trial (CONservative TReatment of Appendicitis in Children a randomised controlled Trial; ISRCTN15830435) - a feasibility trial that compared non-operative treatment (antibiotics) versus appendicectomy for uncomplicated acute appendicitis.
METHODS


Qualitative study embedded within CONTRACT and conducted across three UK children's hospitals. Data were transcribed audio-recordings of 85 CONTRACT recruitment consultations with 58 families; and semi-structured interviews with 35 health professionals and 28 families (34 parents, 14 children) invited to participate in CONTRACT. Data analysis drew on thematic approaches. Throughout CONTRACT, we used findings from the ongoing qualitative analysis to inform bespoke communication training for health professionals recruiting to CONTRACT. Before and after training we also examined qualitative changes in communication during consultations and quantitative changes in recruitment rates.
RESULTS


Bespoke communication training focussed on presenting the trial arms in a balanced way, emphasising clinical equipoise, exploring family treatment preferences and managing families' expectations about the trial's treatment pathways. Analysis of recruitment consultations indicated that health professionals' presentation of treatment arms became increasingly balanced following training, (e.g. avoiding imbalanced terminology) and recruitment rose from 38 to 62%. However, they remained reluctant to explore families' treatment preferences and respond with further information to balance these preferences. Analyses of interviews identified the time constraints of the urgent care setting, concerns about coercion, and reservations about exposing children to conversations about treatment risks as reasons for this reluctance. Interviews with families indicated the importance of clear explanations of trial treatment timings and sensitive communication of treatment allocation for both recruitment and retention.
CONCLUSIONS


Following bespoke training based on the qualitative analyses, health professionals presented CONTRACT to families in clearer and more balanced ways and this was associated with an increase in the recruitment rate. Despite training, health professionals remained reluctant to explore families' treatment preferences. We provide several recommendations to enhance communication, informed consent, recruitment and retention in future trials in urgent care settings.",2020,"Analysis of recruitment consultations indicated that health professionals' presentation of treatment arms became increasingly balanced following training, (e.g. avoiding imbalanced terminology) and recruitment rose from 38 to 62%.","['35 health professionals and 28 families (34 parents, 14 children) invited to participate in CONTRACT', ""Qualitative study embedded within CONTRACT and conducted across three UK children's hospitals""]",['non-operative treatment (antibiotics) versus appendicectomy'],[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}]",[],14.0,0.0498808,"Analysis of recruitment consultations indicated that health professionals' presentation of treatment arms became increasingly balanced following training, (e.g. avoiding imbalanced terminology) and recruitment rose from 38 to 62%.","[{'ForeName': 'Frances C', 'Initials': 'FC', 'LastName': 'Sherratt', 'Affiliation': 'Institute of Population Health Sciences, University of Liverpool, Room 223, Second Floor, Block B, Waterhouse Building, 1-5 Dover Street, Liverpool, L3 5DA, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Beasant', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Esther M', 'Initials': 'EM', 'LastName': 'Crawley', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Nigel J', 'Initials': 'NJ', 'LastName': 'Hall', 'Affiliation': 'University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Young', 'Affiliation': 'Institute of Population Health Sciences, University of Liverpool, Room 223, Second Floor, Block B, Waterhouse Building, 1-5 Dover Street, Liverpool, L3 5DA, UK. byoung@liv.ac.uk.'}]",BMC pediatrics,['10.1186/s12887-020-02040-w']
268,31961448,A fully Bayesian mixture model approach for identifying noncompliance in a regulatory tobacco clinical trial.,"Identifying noncompliance in a randomized trial is challenging, but could be improved by leveraging biomarker data to identify participants that did not comply with their assigned treatment. For randomized trials of very low nicotine content (VLNC) cigarettes, the biomarker of total nicotine equivalents (TNE) could be used to identify noncompliance. Compliant participants should have lower levels of TNEs than participants that did not comply and smoked normal nicotine content cigarettes, resulting in a mixture of compliant and noncompliant participants at each dose level. Thresholds of TNE could then be identified from the compliant groups at each dose level and used to determine which study participants were compliant. Furthermore, proposed biological relationships of TNE with nicotine dose could be incorporated into improve the efficiency of estimation, but may introduce bias if misspecified. To account for multiple modeling assumptions across dose levels, we explore model averaging via reversible jump markov chain monte carlo (MCMC) within each dose level to take advantage of improvements in efficiency when the proposed relationship is true and to downweight the biological model when it is misspecified. In simulation studies, we demonstrate that model averaging in the presence of a correct biological relationship results in a decrease in the mean square error (MSE) of up to 85%, but downweights the model in dose levels where the relationship is not appropriate. We apply our approach to data from a randomized trial of VLNC cigarettes to estimate TNE thresholds and probability of compliance curves as a function of TNEs for each nicotine dose used in the trial.",2020,"In simulation studies, we demonstrate that model averaging in the presence of a correct biological relationship results in a decrease in the mean square error (MSE) of up to 85%, but downweights the model in dose levels where the relationship is not appropriate.",[],"['VLNC', 'total nicotine equivalents (TNE', 'low nicotine content (VLNC) cigarettes', 'TNE']",['mean square error (MSE'],[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}]",,0.0934155,"In simulation studies, we demonstrate that model averaging in the presence of a correct biological relationship results in a decrease in the mean square error (MSE) of up to 85%, but downweights the model in dose levels where the relationship is not appropriate.","[{'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Kaizer', 'Affiliation': 'Department of Biostatistics and Informatics, University of Colorado-Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Koopmeiners', 'Affiliation': 'Division of Biostatistics, University of Minnesota, Minneapolis, Minnesota.'}]",Statistics in medicine,['10.1002/sim.8478']
269,31655788,Las Dos Cosas Versus Exclusive Breastfeeding: A Culturally and Linguistically Exploratory Intervention Study in Hispanic Mothers Living in Kentucky.,"INTRODUCTION


Formula supplementation among infants of breastfeeding Hispanic immigrants is common practice known as las dos cosas. The purpose of this study was to assess the feasibility, effectiveness, and acceptability of a culturally and linguistically diverse intervention to promote exclusive breastfeeding (EBF) for the first 6 months.
METHODS


A sample of 39 Hispanic pregnant women was recruited and randomly assigned to intervention (n = 20) and control groups (n = 19). The intervention included a peer counselor and professional support, and mothers were followed from pregnancy to 6 months after birth.
RESULTS


After the study, women assigned to the intervention group were over three times more likely to EBF their baby through all four postpartum assessed time points (odds ratio = 3.1, 95% confidence interval: 1.1-8.7).
DISCUSSION


This culturally and linguistically diverse intervention contributed to increased EBF duration and decreased formula supplementation in Hispanic mothers up to 6 months postpartum.",2019,This culturally and linguistically diverse intervention contributed to increased EBF duration and decreased formula supplementation in Hispanic mothers up to 6 months postpartum.,"['Hispanic Mothers Living in Kentucky', '39 Hispanic pregnant women', 'Hispanic mothers', 'infants of breastfeeding Hispanic immigrants']","['culturally and linguistically diverse intervention to promote exclusive breastfeeding (EBF', 'Las Dos Cosas Versus Exclusive Breastfeeding']","['EBF duration', 'feasibility, effectiveness, and acceptability']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0022557', 'cui_str': 'Kentucky'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}]","[{'cui': 'C3650830', 'cui_str': 'Promotion of exclusive breastfeeding (procedure)'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0493981,This culturally and linguistically diverse intervention contributed to increased EBF duration and decreased formula supplementation in Hispanic mothers up to 6 months postpartum.,"[{'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Linares', 'Affiliation': ''}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Cartagena', 'Affiliation': ''}, {'ForeName': 'Mary Kay', 'Initials': 'MK', 'LastName': 'Rayens', 'Affiliation': ''}]",Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners,['10.1016/j.pedhc.2019.07.009']
270,32248638,Biobehavioral Intervention Targeting Physical Activity Behavior Change for Older Veterans after Nontraumatic Amputation: A Randomized Controlled Trial.,"BACKGROUND


Lower-limb amputation (LLA) due to non-traumatic vascular etiology is linked to extremely low physical activity and high disability.
OBJECTIVE


To test the feasibility of a biobehavioral intervention designed to promote physical activity.
DESIGN


A randomized, single-blind feasibility trial with a crossover design.
SETTING


Veterans Administration Medical Center.
PARTICIPANTS


Military veterans (age: 65.7 [7.8] years; mean [standard deviation]) with nontraumatic lower-limb amputation (LLA), randomized to two groups: GROUP1 (n = 16) and GROUP2 (n = 15). Both groups had similar baseline amputation characteristics (level of amputation and time since amputation).
INTERVENTIONS


Twelve weekly, 30-minute telehealth sessions of physical activity behavior-change intervention, with GROUP1 participating in weeks 1-12 and GROUP2 in weeks 13-24. GROUP1 noncontact phase in weeks 13-24 and GROUP2 attention control telehealth phase in weeks 1-12.
MAIN OUTCOME MEASURES


Feasibility (participant retention, dose goal attainment, intervention acceptability [Intrinsic Motivation Inventory [IMI] Interest and Enjoyment scale], safety) and signal of efficacy (free-living physical activity [accelerometer-based average daily step count], Late Life Function and Disability Index - Disability Scale [LLFDI-DS]).
RESULTS


Participant retention rate was high (90%), with three participants lost to follow-up during the intervention period. Dose goal attainment was low, with only 10% of participants achieving an a priori walking dose goal. Intervention was rated as acceptable, with mean IMI Interest and Enjoyment score (5.8) statistically higher than the null value of 5.0 (P = .002). There were no between-group differences in adverse event rates (falls: P = .19, lower extremity wounds: P = .60). There was no signal of efficacy for change in average daily step count (d = -0.15) or LLFDI-DS (d = -0.22 and 0.17 for frequency and limitations scales, respectively).
CONCLUSIONS


Telehealth delivered biobehavioral intervention resulted in acceptable participant retention, low dose goal attainment, high participant acceptability, and low safety risk, while having no signal of efficacy (physical activity, disability) for people with nontraumatic LLA.",2020,"There were no between-group differences in adverse event rates (falls: P = 0.19, lower extremity wounds: P = 0.60).","['older Veterans after non-traumatic amputation', 'Military veterans [age: 65.7 (7.8) years; mean (SD)] with non-traumatic lower-limb amputation (LLA', 'Veterans Administration Medical Center']","['biobehavioral intervention', 'Biobehavioral intervention targeting physical activity behavior change', 'GROUP1', 'GROUP2']","['baseline amputation characteristics (level of amputation and time since amputation', 'Feasibility [participant retention, dose goal attainment, intervention acceptability (Intrinsic Motivation Inventory [IMI] Interest and Enjoyment scale), safety] and signal of efficacy [free-living physical activity (accelerometer-based average daily step count), Late Life Function and Disability Index - Disability Scale (LLFDI-DS', 'LLFDI-DS', 'mean IMI Interest and Enjoyment score', 'acceptable participant retention, low dose goal attainment, high participant acceptability, and low safety risk, while having no signal of efficacy (physical activity, disability', 'adverse event rates']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0002694', 'cui_str': 'Traumatic amputation'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}, {'cui': 'C0041735', 'cui_str': 'United States Veterans Administration'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1271922', 'cui_str': 'Target physical activity'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0880669,"There were no between-group differences in adverse event rates (falls: P = 0.19, lower extremity wounds: P = 0.60).","[{'ForeName': 'Cory L', 'Initials': 'CL', 'LastName': 'Christiansen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Colorado, Aurora, CO.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Miller', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Kline', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Colorado, Aurora, CO.'}, {'ForeName': 'Thomas T', 'Initials': 'TT', 'LastName': 'Fields', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Rocky Mountain Regional Medical Center, Aurora, CO.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sullivan', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Blatchford', 'Affiliation': 'VA Eastern Colorado Geriatric Research, Education, and Clinical Center, Rocky Mountain Regional VA Medical Center, Aurora, CO.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Stevens-Lapsley', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Colorado, Aurora, CO.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12374']
271,32203712,Infant respiratory syncytial virus prophylaxis and nasopharyngeal microbiota until 6 years of life: a subanalysis of the MAKI randomised controlled trial.,"BACKGROUND


Respiratory syncytial virus (RSV) infection during infancy is suggested to cause long-term wheeze. In turn, wheeze has been associated with bacterial dysbiosis of the respiratory tract. We investigated the effects of RSV prophylaxis with palivizumab in otherwise healthy preterm infants on respiratory microbiota composition at 1 year and 6 years of age.
METHODS


In a multicentre, single-blind, randomised, placebo-controlled trial (the MAKI trial), infants born between 32-35 weeks of gestation, in one university and in 15 regional hospitals in the the Netherlands, were randomly assigned (1:1) to receive palivizumab or placebo during the RSV season of their first year of life. Intramuscular injections of palivizumab 15 mg/kg or placebo were given during one RSV season: either from Oct 1, or from discharge from the neonatal unit until March 10 (minimun of 2 and maximum of 5 injections were given). Children were 6 months old or younger at the start of the RSV season; exclusion criteria included congenital heart disease, bronchopulmonary dysplasia, Down's syndrome, or other serious congenital disorders, use of mechanical ventilation at birth, treatment with surfactant, or physician-diagnosed wheeze before the start of the RSV season. Children were followed up for clinical symptoms until 6 years of age. For this subanalysis, we obtained nasopharyngeal swabs from children aged 1 year and 6 years and analysed them using 16S-rRNA sequencing. At 6 years we also measured reversible airway obstruction. The primary outcome was the effect of palivizumab during infancy on the respiratory microbiota composition at age 1 year and 6 years (intention-to-treat analysis). The trial is registered in the ISRCTN registry, number ISRCTN73641710.
FINDINGS


From April 1, 2008, to Dec 31, 2010, 429 infants were enrolled in the MAKI trial (n=214 to the palivizumab group; n=215 to the placebo group). At 1 year, we collected swabs and sequenced DNA from 170 (40%) of 429 children, of which 145 (85%) samples had high-quality DNA. The overall microbiota composition was significantly different (R 2  1·3%; p=0·0185) between the palivizumab group and the placebo group at 1 year of life; children in the palivizumab group had a significantly lower abundance of the Staphylococcus-dominated cluster (odds ratio 0·28 [95% CI 0·11-0·68]; p=0·00394), an increased abundance of biomarker species, such as Klebsiella, and a more diverse set of oral taxa, including Streptococcus spp, compared with children in the placebo group. At 6 years, we collected swabs and sequenced DNA from 349 (88%) of 395 children who completed follow-up, of which 342 (98%) samples had high-quality DNA. The overall microbiota composition was not significantly different between groups at 6 years (R 2  0·6%; p=0·0575); however, children in the palivizumab group had a significantly increased abundance of Haemophilus spp and lower abundance of Moraxella and Neisseriaceae spp compared with children in the placebo group. Absence of PCR-confirmed RSV infection at 1 year was significantly associated with a higher abundance of Haemophilus spp at age 6 years and a significantly lower abundance of Moraxella and Neisseriaceae than children with RSV infection at 1 year. Reversible airway obstruction at 6 years was also positively associated with Haemophilus abundance and negatively associated with the abundance of health-associated taxa, such as Moraxella, Corynebacterium, Dolosigranulum, and Staphylococcus, even after correction for RSV immunoprophylaxis (all: p<0·05). Additionally, reversible airway instruction was associated with significantly higher Streptococcus pneumoniae abundance.
INTERPRETATION


Palivizumab in infancy in otherwise healthy preterm infants is associated with persistent effects on the abundance of specific, potentially pathogenic, microbial taxa in the respiratory tract. Several of the palivizumab-associated biomarker species were associated with reversible airway obstruction at age 6 years. These results warrant further studies to establish the long-term ecological effects and health consequences of palivizumab in infancy.
FUNDING


MedImmune.",2020,The overall microbiota composition was not significantly different between groups at 6 years (,"['otherwise healthy preterm infants', 'otherwise healthy preterm infants on respiratory microbiota composition at 1 year and 6 years of age', '395 children who completed follow-up, of which 342 (98%) samples had high-quality DNA', 'infants born between 32-35 weeks of gestation, in one university and in 15 regional hospitals in the the Netherlands', 'Infant respiratory syncytial virus prophylaxis and nasopharyngeal microbiota until 6 years of life', ""Children were 6 months old or younger at the start of the RSV season; exclusion criteria included congenital heart disease, bronchopulmonary dysplasia, Down's syndrome, or other serious congenital disorders, use of mechanical ventilation at birth, treatment with surfactant, or physician-diagnosed wheeze before the start of the RSV season"", 'children aged 1 year and 6 years and analysed them using 16S-rRNA sequencing', 'From April 1, 2008, to Dec 31, 2010, 429 infants were enrolled in the MAKI trial (n=214 to the palivizumab group; n=215 to the placebo group']","['palivizumab', 'reversible airway instruction', 'palivizumab or placebo', 'palivizumab 15 mg/kg or placebo', 'placebo', 'RSV prophylaxis with palivizumab']","['respiratory microbiota composition at age 1 year and 6 years (intention-to-treat analysis', 'abundance of the Staphylococcus-dominated cluster', 'reversible airway obstruction', 'abundance of biomarker species, such as Klebsiella', 'abundance of Haemophilus spp and lower abundance of Moraxella and Neisseriaceae spp', 'Reversible airway obstruction', 'overall microbiota composition', 'Streptococcus pneumoniae abundance']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0027442', 'cui_str': 'Rhinopharynx'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0444858', 'cui_str': 'AM 6 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease (disorder)'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0013080', 'cui_str': '47,XY,+21'}, {'cui': 'C0242354', 'cui_str': 'Congenital Disorders'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0672596', 'cui_str': 'palivizumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0672596', 'cui_str': 'palivizumab'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0038170', 'cui_str': 'Staphylococcus'}, {'cui': 'C0421207', 'cui_str': 'Airways obstruction reversible (finding)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022727', 'cui_str': 'Klebsiella'}, {'cui': 'C0018479', 'cui_str': 'Hemophilus'}, {'cui': 'C0075148', 'cui_str': 'stable plasma protein solution'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026536', 'cui_str': 'Moraxella'}, {'cui': 'C0027576', 'cui_str': 'Neisseriaceae'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}]",429.0,0.544541,The overall microbiota composition was not significantly different between groups at 6 years (,"[{'ForeName': 'Wing Ho', 'Initials': 'WH', 'LastName': 'Man', 'Affiliation': ""Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands; Spaarne Gasthuis Academy, Hoofddorp and Haarlem, Netherlands; Department of Pediatrics, Leiden University Medical Center, Leiden, Netherlands.""}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'Scheltema', 'Affiliation': ""Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Clerc', 'Affiliation': ""Medical Research Council-University of Edinburgh Centre for Inflammation Research, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Marlies A', 'Initials': 'MA', 'LastName': 'van Houten', 'Affiliation': 'Spaarne Gasthuis Academy, Hoofddorp and Haarlem, Netherlands.'}, {'ForeName': 'Elisabeth E', 'Initials': 'EE', 'LastName': 'Nibbelke', 'Affiliation': ""Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands.""}, {'ForeName': 'Niek B', 'Initials': 'NB', 'LastName': 'Achten', 'Affiliation': ""Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands.""}, {'ForeName': 'Kayleigh', 'Initials': 'K', 'LastName': 'Arp', 'Affiliation': ""Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands.""}, {'ForeName': 'Elisabeth A M', 'Initials': 'EAM', 'LastName': 'Sanders', 'Affiliation': ""Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands.""}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Bont', 'Affiliation': ""Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands.""}, {'ForeName': 'Debby', 'Initials': 'D', 'LastName': 'Bogaert', 'Affiliation': ""Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands; Medical Research Council-University of Edinburgh Centre for Inflammation Research, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK. Electronic address: d.bogaert@ed.ac.uk.""}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30470-9']
272,31685489,Effect of Surgical Versus Medical Therapy on Diabetic Kidney Disease Over 5 Years in Severely Obese Adolescents With Type 2 Diabetes.,"OBJECTIVE


To compare diabetic kidney disease (DKD) rates over 5 years of follow-up in two cohorts of severely obese adolescents with type 2 diabetes (T2D) undergoing medical or surgical treatment for T2D.
RESEARCH DESIGN AND METHODS


A secondary analysis was performed of data collected from obese participants of similar age and racial distribution enrolled in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) and the Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY) studies. Teen-LABS participants underwent metabolic bariatric surgery (MBS). TODAY participants were randomized to metformin alone or in combination with rosiglitazone or intensive lifestyle intervention, with insulin therapy given for glycemic progression. Glycemic control, BMI, estimated glomerular filtration rate (eGFR), urinary albumin excretion (UAE), and prevalence of hyperfiltration (eGFR ≥135 mL/min/1.73 m 2 ) and elevated UAE (≥30 mg/g) were assessed annually.
RESULTS


Participants with T2D from Teen-LABS ( n  = 30, mean ± SD age, 16.9 ± 1.3 years; 70% female; 60% white; BMI 54.4 ± 9.5 kg/m 2 ) and TODAY ( n  = 63, age 15.3 ± 1.3 years; 56% female; 71% white; BMI 40.5 ± 4.9 kg/m 2 ) were compared. During 5 years of follow-up, hyperfiltration decreased from 21% to 18% in Teen-LABS and increased from 7% to 48% in TODAY. Elevated UAE decreased from 27% to 5% in Teen-LABS and increased from 21% to 43% in TODAY. Adjusting for baseline age, sex, BMI, and HbA 1c , TODAY participants had a greater odds of hyperfiltration (odds ratio 15.7 [95% CI 2.6, 94.3]) and elevated UAE (27.3 [4.9, 149.9]) at 5 years of follow-up.
CONCLUSIONS


Compared with MBS, medical treatment of obese youth with T2D was associated with a higher odds of DKD over 5 years.",2020,"Compared with MBS, medical treatment of obese youth with T2D was associated with a higher odds of DKD over 5 years.","['Participants with T2D from Teen-LABS ( n  = 30, mean ± SD age, 16.9 ± 1.3 years; 70% female; 60% white; BMI 54.4 ± 9.5 kg/m 2 ) and TODAY ( n  = 63, age 15.3 ± 1.3 years; 56% female; 71% white; BMI 40.5 ± 4.9 kg/m 2 ', 'Diabetic Kidney Disease Over 5 Years in Severely Obese Adolescents With Type 2 Diabetes', 'severely obese adolescents with type 2 diabetes ', 'T2D) undergoing medical or surgical treatment for T2D', 'obese participants of similar age and racial distribution enrolled in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) and the Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY) studies']","['Surgical Versus Medical Therapy', 'metabolic bariatric surgery (MBS', 'metformin alone or in combination with rosiglitazone or intensive lifestyle intervention, with insulin therapy']","['Elevated UAE', 'Glycemic control, BMI, estimated glomerular filtration rate (eGFR), urinary albumin excretion (UAE), and prevalence of hyperfiltration (eGFR ≥135 mL/min/1.73 m 2 ) and elevated UAE', 'diabetic kidney disease (DKD) rates']","[{'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}]",,0.0493397,"Compared with MBS, medical treatment of obese youth with T2D was associated with a higher odds of DKD over 5 years.","[{'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Bjornstad', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO petter.bjornstad@childrenscolorado.org.""}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Hughan', 'Affiliation': ""University of Pittsburgh and UPMC Children's Hospital Pittsburgh, Pittsburgh, PA.""}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Kelsey', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lynch', 'Affiliation': 'The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Nehus', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mitsnefes', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Jenkins', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Inge', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Nadeau', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO.""}]",Diabetes care,['10.2337/dc19-0708']
273,32236715,Effect of triamcinolone acetonide on stiffness after surgical treatment of proximal humerus fractures: a randomized controlled study.,"INTRODUCTION


The primary aim of this study was to determine the effectiveness and safety of an intraarticular triamcinolone injection for the treatment of stiffness after the operative treatment of proximal humerus fractures.
MATERIALS AND METHODS


88 patients who underwent plate fixation for proximal humerus fractures were enrolled. The patients were randomly divided into two groups, with Group I receiving a glenohumeral injection of triamcinolone 8 weeks postoperatively and Group II receiving no injection postoperatively. Outcomes were measured and compared based on the range of motion (ROM) and functional scores. Follow-up outcomes were assessed at initial, 3, 6 and 12 months postoperatively and at the last follow-up. Shoulder trauma series were taken at every visit to evaluate the fracture healing. The mean follow-up period was 25.37 (± 3.85) months Group I and 24.24 (± 6.23) months for group II.
RESULTS


In both groups, the final outcome of the ROM and functional outcome was significantly better at last F/U than at postoperative 8 weeks. Group I had significantly better results than Group II at postoperative 3 and 6 month in terms of forward flexion, external rotation, and VAS for pain. Also, Group I showed better performance in terms of ASES and Constant score at postoperative 3 months. The fracture union rate did not differ between Groups I and II.
CONCLUSIONS


Postoperative glenohumeral injection of triamcinolone is a safe and effective treatment modality for shoulder stiffness after internal fixation of proximal humerus fractures during the early period of rehabilitation.",2020,"Group I had significantly better results than Group II at postoperative 3 and 6 month in terms of forward flexion, external rotation, and VAS for pain.","['proximal humerus fractures', '88 patients who underwent plate fixation for proximal humerus fractures were enrolled']","['glenohumeral injection of triamcinolone 8\xa0weeks postoperatively and Group II receiving no injection postoperatively', 'triamcinolone acetonide', 'intraarticular triamcinolone injection', 'triamcinolone']","['fracture union rate', 'range of motion (ROM) and functional scores', 'forward flexion, external rotation, and VAS for pain', 'ASES and Constant score', 'effectiveness and safety', 'ROM and functional outcome']","[{'cui': 'C0588209', 'cui_str': 'Bone structure of proximal humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C1960581', 'cui_str': 'Injection of triamcinolone'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C4084816', 'cui_str': 'Triamcinolone Injection'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}]","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",88.0,0.0209488,"Group I had significantly better results than Group II at postoperative 3 and 6 month in terms of forward flexion, external rotation, and VAS for pain.","[{'ForeName': 'Yang-Soo', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 505 Banpo-dong, Seocho-gu, Seoul, 137-701, Korea.""}, {'ForeName': 'Kyoung-Geun', 'Initials': 'KG', 'LastName': 'Lee', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 505 Banpo-dong, Seocho-gu, Seoul, 137-701, Korea.""}, {'ForeName': 'Hyo-Jin', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 505 Banpo-dong, Seocho-gu, Seoul, 137-701, Korea. hyojin1229@gmail.com.""}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03425-3']
274,32227128,"Association of Sex With Severity of Coronary Artery Disease, Ischemia, and Symptom Burden in Patients With Moderate or Severe Ischemia: Secondary Analysis of the ISCHEMIA Randomized Clinical Trial.","Importance


While many features of stable ischemic heart disease vary by sex, differences in ischemia, coronary anatomy, and symptoms by sex have not been investigated among patients with moderate or severe ischemia. The enrolled ISCHEMIA trial cohort that underwent coronary computed tomographic angiography (CCTA) was required to have obstructive coronary artery disease (CAD) for randomization.
Objective


To describe sex differences in stress testing, CCTA findings, and symptoms in ISCHEMIA trial participants.
Design, Setting, and Participants


This secondary analysis of the multicenter ISCHEMIA randomized clinical trial analyzed baseline characteristics of patients with stable ischemic heart disease. Individuals were enrolled from July 2012 to January 2018 based on local reading of moderate or severe ischemia on a stress test, after which blinded CCTA was performed in most. Core laboratories reviewed stress tests and CCTAs. Participants with no obstructive CAD or with left main CAD of 50% or greater were excluded. Those who met eligibility criteria including CCTA (if performed) were randomized to a routine invasive or a conservative management strategy (N = 5179). Angina was assessed using the Seattle Angina Questionnaire. Analysis began October 1, 2018.
Interventions


CCTA and angina assessment.
Main Outcomes and Measures


Sex differences in stress test, CCTA findings, and symptom severity.
Results


Of 8518 patients enrolled, 6256 (77%) were men. Women were more likely to have no obstructive CAD (<50% stenosis in all vessels on CCTA) (353 of 1022 [34.4%] vs 378 of 3353 [11.3%]). Of individuals who were randomized, women had more angina at baseline than men (median [interquartile range] Seattle Angina Questionnaire Angina Frequency score: 80 [70-100] vs 90 [70-100]). Women had less severe ischemia on stress imaging (383 of 919 [41.7%] vs 1361 of 2972 [45.9%] with severe ischemia; 386 of 919 [42.0%] vs 1215 of 2972 [40.9%] with moderate ischemia; and 150 of 919 [16.4%] vs 394 of 2972 [13.3%] with mild or no ischemia). Ischemia was similar by sex on exercise tolerance testing. Women had less extensive CAD on CCTA (205 of 568 women [36%] vs 1142 of 2418 men [47%] with 3-vessel disease; 184 of 568 women [32%] vs 754 of 2418 men [31%] with 2-vessel disease; and 178 of 568 women [31%] vs 519 of 2418 men [22%] with 1-vessel disease). Female sex was independently associated with greater angina frequency (odds ratio, 1.41; 95% CI, 1.13-1.76).
Conclusions and Relevance


Women in the ISCHEMIA trial had more frequent angina, independent of less extensive CAD, and less severe ischemia than men. These findings reflect inherent sex differences in the complex relationships between angina, atherosclerosis, and ischemia that may have implications for testing and treatment of patients with suspected stable ischemic heart disease.
Trial Registration


ClinicalTrials.gov Identifier: NCT01471522.",2020,Women had less severe ischemia on stress imaging (383 of 919 [41.7%] vs 1361 of 2972 [45.9%] with severe ischemia; 386 of 919 [42.0%] vs 1215 of 2972 [40.9%] with moderate ischemia; and 150 of 919 [16.4%] vs 394 of 2972 [13.3%] with mild or no ischemia).,"['patients with suspected stable ischemic heart disease', 'Individuals were enrolled from July 2012 to January 2018 based on local reading of moderate or severe ischemia on a stress test, after which blinded CCTA was performed in most', 'patients with stable ischemic heart disease', 'patients with moderate or severe ischemia', 'Participants with no obstructive CAD or with left main CAD of 50% or greater were excluded', 'Women had less extensive CAD on CCTA (205 of 568 women [36%] vs 1142 of 2418 men [47%] with 3-vessel disease; 184 of 568 women [32%] vs 754 of 2418 men [31%] with 2-vessel disease; and 178 of 568 women [31%] vs 519 of 2418 men [22%] with 1-vessel disease', 'Patients With Moderate or Severe Ischemia', '8518 patients enrolled, 6256 (77%) were men', 'Of individuals who were randomized, women had more angina at baseline than men (median [interquartile range] Seattle Angina Questionnaire Angina Frequency score: 80 [70-100] vs 90 [70-100']","['coronary computed tomographic angiography (CCTA', 'routine invasive or a conservative management strategy']","['obstructive CAD', 'angina frequency', 'severe ischemia', 'Measures\n\n\nSex differences in stress test, CCTA findings, and symptom severity', 'Ischemia', 'severe ischemia on stress imaging', 'Seattle Angina Questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}]","[{'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036866', 'cui_str': 'Sexual Dimorphism'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",8518.0,0.20527,Women had less severe ischemia on stress imaging (383 of 919 [41.7%] vs 1361 of 2972 [45.9%] with severe ischemia; 386 of 919 [42.0%] vs 1215 of 2972 [40.9%] with moderate ischemia; and 150 of 919 [16.4%] vs 394 of 2972 [13.3%] with mild or no ischemia).,"[{'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': 'NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Leslee J', 'Initials': 'LJ', 'LastName': 'Shaw', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Min', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': 'UMKC School of Medicine, Kansas City, Missouri.'}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': 'St Louis University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Berman', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Picard', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston.'}, {'ForeName': 'Raymond Y', 'Initials': 'RY', 'LastName': 'Kwong', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'C Noel', 'Initials': 'CN', 'LastName': 'Bairey-Merz', 'Affiliation': 'Cedars-Sinai Smidt Heart Institute, Los Angeles, California.'}, {'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Cyr', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Lopez-Sendon', 'Affiliation': 'Hospital Universitario La Paz. Idipaz. UAM. CIBER-CV, Madrid, Spain.'}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Held', 'Affiliation': 'Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Szwed', 'Affiliation': 'National Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Roxy', 'Initials': 'R', 'LastName': 'Senior', 'Affiliation': 'Northwick Park Hospital-Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Gosselin', 'Affiliation': 'Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Rajesh Gopalan', 'Initials': 'RG', 'LastName': 'Nair', 'Affiliation': 'Government Medical College, Kerla, India.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elghamaz', 'Affiliation': 'Northwick Park Hospital-Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Bockeria', 'Affiliation': 'National Research Center for Cardiovascular Surgery, Moscow, Russia.'}, {'ForeName': 'Jiyan', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Chernyavskiy', 'Affiliation': 'E.Meshalkin National medical research center of the Ministry of Health of the Russian Federation (E.Meshalkin NMRC), Moscow, Russia.'}, {'ForeName': 'Balram', 'Initials': 'B', 'LastName': 'Bhargava', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': 'NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Sasa B', 'Initials': 'SB', 'LastName': 'Hinic', 'Affiliation': 'UHC Bezanijska kosa, Belgrade, Serbia.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Jaroch', 'Affiliation': 'Wroclaw Medical University, T. Marciniak Hospital, Wroclaw, Poland.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Hoye', 'Affiliation': 'The University of Hull/Castle Hill Hospital, Cottingham, United Kingdom.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Berger', 'Affiliation': 'NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': 'VA New England Healthcare System/Boston, Boston, Massachusetts.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': 'NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2020.0822']
275,32242905,Cost-effectiveness Analysis of the Elder-Friendly Approaches to the Surgical Environment (EASE) Intervention for Emergency Abdominal Surgical Care of Adults Aged 65 Years and Older.,"Importance


The Elder-Friendly Approaches to the Surgical Environment (EASE) initiative is a novel approach to acute surgical care for elderly patients.
Objective


To determine the cost-effectiveness of EASE.
Design, Setting, and Participants


An economic evaluation from the perspective of the health care system was conducted as part of the controlled before-and-after EASE study at 2 tertiary care centers, the University of Alberta Hospital and Foothills Medical Centre. Participants included elderly adults (aged ≥65 years) admitted for emergency abdominal surgery between 2014 and 2017. Data were analyzed from April 2018 to February 2019.
Main Outcomes and Measures


Data were captured at both control and intervention sites before and after implementation of the EASE intervention. Resource use was captured over 6 months of follow-up and was converted to costs. Utility was measured with the EuroQol Five-Dimensions Three-Levels instrument at 6 weeks and 6 months of follow-up. The differences-in-differences method was used to estimate the association of the intervention with cost and quality-adjusted life-years. For a subset of participants, self-reported out-of-pocket health care costs were collected using the Resource Use Inventory at 6 months.
Results


A total of 675 participants were included (mean [SD] age, 75.3 [7.9] years; 333 women [49.3%]), 289 in the intervention group and 386 in the control group. The mean (SD) cost per control participant was $36 995 ($44 169) before EASE and $35 032 ($43 611) after EASE (all costs are shown in 2018 Canadian dollars). The mean (SD) cost per intervention participant was $56 143 ($74 039) before EASE and $39 001 ($59 854) after EASE. Controlling for age, sex, and Clinical Frailty Score, the EASE intervention was associated with a mean (SE) cost reduction of 23.5% (12.5%) (P = .02). The change in quality-adjusted life-years observed associated with the intervention was not statistically significant (mean [SE], 0.00001 [0.0001] quality-adjusted life-year; P = .72). The Resource Use Inventory was collected for 331 participants. The mean (SE) odds ratio for having 0 out-of-pocket expenses because of the intervention, compared with having expenses greater than 0, was 15.77 (3.37) (P = .02). Among participants with Resource Use Inventory costs greater than 0, EASE was not associated with a change in spending (mean [SE] reduction associated with EASE, 19.1% [45.2%]; P = .57).
Conclusions and Relevance


This study suggests that the EASE intervention was associated with a reduction in costs and no change in quality-adjusted life-years. In locations that lack capacity to implement this intervention, costs to increase capacity should be weighed against the estimated costs avoided.",2020,"The change in quality-adjusted life-years observed associated with the intervention was not statistically significant (mean [SE], 0.00001","['elderly patients', '2 tertiary care centers, the University of Alberta Hospital and Foothills Medical Centre', 'Participants included elderly adults (aged ≥65 years) admitted for emergency abdominal surgery between 2014 and 2017', 'Adults', 'A total of 675 participants were included (mean [SD] age, 75.3 [7.9] years; 333 women [49.3%]), 289 in the intervention group and 386 in the control group', '331 participants', 'Aged 65 Years and Older']",[],"['mean (SD) cost per intervention participant', 'quality-adjusted life-years', 'mean (SE) odds ratio', 'mean (SD) cost per control participant']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517854', 'cui_str': '675'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",675.0,0.0279529,"The change in quality-adjusted life-years observed associated with the intervention was not statistically significant (mean [SE], 0.00001","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hofmeister', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Rachel G', 'Initials': 'RG', 'LastName': 'Khadaroo', 'Affiliation': 'Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Jayna', 'Initials': 'J', 'LastName': 'Holroyd-Leduc', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Padwal', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wagg', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Warkentin', 'Affiliation': 'Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Clement', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.2034']
276,31073188,Gait training using a robotic hip exoskeleton improves metabolic gait efficiency in the elderly.,"Robotic exoskeletons are regarded as promising technologies for neurological gait rehabilitation but have been investigated comparatively little as training aides to facilitate active aging in the elderly. This study investigated the feasibility of an exoskeletal Active Pelvis Orthosis (APO) for cardiopulmonary gait training in the elderly. Ten healthy elderly volunteers exhibited a decreased (-26.6 ± 16.1%) Metabolic Cost of Transport (MCoT) during treadmill walking following a 4-week APO-assisted training program, while no significant changes were observed for a randomly assigned control group (n = 10) performing traditional self-paced overground walking. Moreover, robot-assisted locomotion was found to require 4.24 ± 2.57% less oxygen consumption than free treadmill walking at the same speed. These findings support the adoption of exoskeletal devices for the training of frail individuals, thus opening new possibilities for sustainable strategies for healthy aging.",2019,"Moreover, robot-assisted locomotion was found to require 4.24 ± 2.57% less oxygen consumption than free treadmill walking at the same speed.","['elderly', 'frail individuals', 'healthy aging', 'Ten healthy elderly volunteers exhibited a decreased (-26.6\u2009±\u200916.1']","['exoskeletal Active Pelvis Orthosis (APO', 'robotic hip exoskeleton', 'cardiopulmonary gait training', 'Gait training']","['Metabolic Cost of Transport (MCoT', 'metabolic gait efficiency', 'oxygen consumption']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2963171', 'cui_str': 'Ageing Well'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C4319689', 'cui_str': 'Sixteen point one'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure (procedure)'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}]",10.0,0.0132729,"Moreover, robot-assisted locomotion was found to require 4.24 ± 2.57% less oxygen consumption than free treadmill walking at the same speed.","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Martini', 'Affiliation': ""The BioRobotics Institute, Scuola Superiore Sant'Anna, Pisa, Italy. elena.martini@santannapisa.it.""}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Crea', 'Affiliation': ""The BioRobotics Institute, Scuola Superiore Sant'Anna, Pisa, Italy.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Parri', 'Affiliation': ""The BioRobotics Institute, Scuola Superiore Sant'Anna, Pisa, Italy.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Bastiani', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Faraguna', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Zach', 'Initials': 'Z', 'LastName': 'McKinney', 'Affiliation': ""The BioRobotics Institute, Scuola Superiore Sant'Anna, Pisa, Italy.""}, {'ForeName': 'Raffaello', 'Initials': 'R', 'LastName': 'Molino-Lova', 'Affiliation': 'Fondazione Don Carlo Gnocchi, Milan, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Pratali', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Vitiello', 'Affiliation': ""The BioRobotics Institute, Scuola Superiore Sant'Anna, Pisa, Italy.""}]",Scientific reports,['10.1038/s41598-019-43628-2']
277,31073189,Symptom trajectories in patients with panic disorder in a primary care intervention: Results from a randomized controlled trial (PARADISE).,"This analysis aims to identify and characterize symptom trajectories in primary care patients with panic disorder with/without agoraphobia (PD/AG) who participated in a primary care team based training involving elements of cognitive behavioural therapy (CBT). Growth Mixture Modeling was used to identify different latent classes of change in patients with PD/AG (N = 176) who underwent treatment including CBT elements. We identified three patient classes with distinct similar trajectories. Class 1 (n = 58, mean age: 46.2 years ± 13.4 years, 81% women) consisted of patients with an initially high symptom burden, but symptoms declined constantly over the intervention period. Symptoms of patients in class 2 (n = 89, mean age: 44.2 years ± 14.5 years, 67.4% women) declined rapidly at the beginning, then patients went into a plateau-phase. The third class (n = 29, mean age: 47.0 years ± 12.4 years, 65.5% women) was characterized by an unstable course and had the worse outcome. Our findings show that only a minority did not respond to the treatment. To identify this minority and refer to a specialist would help patients to get intensive care in time.",2019,Growth Mixture Modeling was used to identify different latent classes of change in patients with PD/AG (N = 176) who underwent treatment including CBT elements.,"['patients with PD/AG (N\u2009=\u2009176) who underwent treatment including CBT\xa0elements', 'Symptoms of patients in class\xa02 (n\u2009=\u200989, mean age: 44.2 years\u2009±\u200914.5 years, 67.4% women) declined rapidly at the beginning, then patients went into a plateau-phase', 'primary care patients with panic disorder with/without agoraphobia\xa0(PD/AG) who participated in a', 'patients with panic disorder in a primary care intervention', 'Class\xa01 (n\u2009=\u200958, mean age: 46.2 years\u2009±\u200913.4 years, 81% women) consisted of patients with an initially high symptom burden, but symptoms declined constantly over the intervention period']",['primary care team based training involving elements of cognitive behavioural therapy (CBT'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030319', 'cui_str': 'Panic Disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C4517558', 'cui_str': 'Thirteen point four'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]",[],,0.0236642,Growth Mixture Modeling was used to identify different latent classes of change in patients with PD/AG (N = 176) who underwent treatment including CBT elements.,"[{'ForeName': 'Karoline', 'Initials': 'K', 'LastName': 'Lukaschek', 'Affiliation': 'Institute of General Practice and Family Medicine, University Hospital of Ludwig-Maximilians-University Munich, Pettenkoferstr. 10, D-80336, Munich, Germany.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Hiller', 'Affiliation': 'Institute of General Practice and Family Medicine, Jena University Hospital, Bachstrasse 18, D-07743, Jena, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schumacher', 'Affiliation': 'Centre for Clinical Studies, Jena University Hospital, Jena, Salvador-Allende-Platz 27, D-07747, Jena, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Teismann', 'Affiliation': 'Mental Health Research and Treatment Center, Ruhr-Universität Bochum, Massenbergstr. 11, D-44787, Bochum, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Breitbart', 'Affiliation': 'Institute of General Practice and Family Medicine, Jena University Hospital, Bachstrasse 18, D-07743, Jena, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brettschneider', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, D-20246, Hamburg, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, D-20246, Hamburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Margraf', 'Affiliation': 'Mental Health Research and Treatment Center, Ruhr-Universität Bochum, Massenbergstr. 11, D-44787, Bochum, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Gensichen', 'Affiliation': 'Institute of General Practice and Family Medicine, University Hospital of Ludwig-Maximilians-University Munich, Pettenkoferstr. 10, D-80336, Munich, Germany. jochen.gensichen@med.uni-muenchen.de.'}]",Scientific reports,['10.1038/s41598-019-43487-x']
278,32245781,"Darbepoetin Alfa in Patients with Advanced CKD without Diabetes: Randomized, Controlled Trial.","BACKGROUND AND OBJECTIVES


Large, randomized, controlled trials targeting higher hemoglobin level with erythropoiesis-stimulating agents for Western patients with CKD showed harm. However, the effect of anemia correction using erythropoiesis-stimulating agents may differ between CKD subpopulations. The Prevention of ESKD by Darbepoetin Alfa in CKD Patients with Non-diabetic Kidney Disease study, a multicenter, randomized, open-label, parallel-group study, aimed to examine the effect of targeting hemoglobin levels of 11-13 g/dl using darbepoetin alfa with reference to a low-hemoglobin target of 9-11 g/dl on kidney outcome in patients with advanced CKD without diabetes in Japan.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


We enrolled 491 patients with CKD without diabetes, and an eGFR of 8-20 ml/min per 1.73 m 2 . Of these 491 patients, 239 and 240 were ultimately assigned to the high- and low-hemoglobin groups, respectively (12 patients were excluded). The primary outcome was a kidney composite end point (starting maintenance dialysis, kidney transplantation, eGFR≤6 ml/min per 1.73 m 2 , and 50% reduction in eGFR).
RESULTS


Mean hemoglobin levels were 11.2±1.1 and 10.0±0.9 g/dl in the high- and low-hemoglobin groups, respectively, during the mean study period of 73.5±29.7 weeks. The kidney composite end point occurred in 105 (44%) and 116 (48%) patients in the high- and low-hemoglobin groups, respectively (log-rank test;  P =0.32). The adjusted Cox proportional hazards model showed that the hazard ratio for the high- versus low-hemoglobin group was 0.78 (95% confidence interval, 0.60 to 1.03;  P =0.08). Cardiovascular events occurred in 19 (8%) and 16 (7%) patients in each group, respectively, with no significant between-group difference (log-rank test;  P =0.66).
CONCLUSIONS


Targeting a higher hemoglobin level (11-13 g/dl) with darbepoetin alfa did not improve kidney outcome compared with targeting a lower hemoglobin level (9-11 g/dl) in patients with advanced CKD without diabetes.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Prevention of ESKD by Darbepoetin Alfa in CKD Patients with Non-diabetic Kidney Disease (PREDICT), NCT01581073.",2020,"Cardiovascular events occurred in 19 (8%) and 16 (7%) patients in each group, respectively, with no significant between-group difference (log-rank test;  P =0.66).
","['Western patients with CKD', '491 patients, 239 and 240 were ultimately assigned to the high- and low-hemoglobin groups, respectively (12 patients were excluded', 'patients with advanced CKD without diabetes', 'patients with advanced CKD without diabetes in Japan', '491 patients with CKD without diabetes, and an eGFR of 8-20 ml/min per 1.73 m 2 ', 'CKD Patients with Non-diabetic Kidney Disease', 'Patients with Advanced CKD without Diabetes']",['Darbepoetin Alfa'],"['Mean hemoglobin levels', 'kidney outcome', 'Cardiovascular events', 'kidney composite end point', 'kidney composite end point (starting maintenance dialysis, kidney transplantation, eGFR≤6 ml/min per 1.73 m 2 , and 50% reduction in eGFR', 'hemoglobin level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}]","[{'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]",491.0,0.121782,"Cardiovascular events occurred in 19 (8%) and 16 (7%) patients in each group, respectively, with no significant between-group difference (log-rank test;  P =0.66).
","[{'ForeName': 'Terumasa', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Department of Kidney Disease and Hypertension, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Maruyama', 'Affiliation': 'Department of Nephrology, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Nangaku', 'Affiliation': 'Division of Nephrology and Endocrinology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Ichiei', 'Initials': 'I', 'LastName': 'Narita', 'Affiliation': 'Division of Clinical Nephrology and Rheumatology, Niigata University, Niigata, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Hirakata', 'Affiliation': 'Fukuoka Renal Clinic, Fukuoka, Japan.'}, {'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'Division of Health Data Science, Translational Research Center for Medical Innovation, Kobe, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Biomedical Statistics and Bioinformatics, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Tsubakihara', 'Affiliation': 'Graduate School of Health Care Sciences, Jikei Institute, Osaka, Japan.'}, {'ForeName': 'Enyu', 'Initials': 'E', 'LastName': 'Imai', 'Affiliation': 'Nakayamadera Imai Clinic, Takarazuka, Japan ads12069@nifty.com.'}, {'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Akizawa', 'Affiliation': 'Division of Nephrology, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.08900719']
279,32197931,[How to reduce lung cancer mortality among people living with HIV?],"Lung cancer is the leading cause of cancer related death among people living with HIV (PLHIV). Tobacco exposure is higher among PLHIV (38.5%) and mainly explains the increased risk of lung cancer. To reduce lung cancer mortality, two approaches need to be implemented: lung cancer screening with low-dose thoracic CT scan and smoking cessation. Low dose CT scan is feasible in PLHIV. The false positive rate is not higher than in the general population, except for cases with CD4 <200/mm 3 . The impact on survival remains to be assessed. Despite the high prevalence, smoking cessation research among PLHIV is scarce. Very low quality data from 11 studies showed that more intensive smoking cessation interventions were effective in achieving short-term abstinence. A single randomized phase 3 trial showed the superiority of varenicline compared to placebo in long-term smoking cessation. The maximum benefit of reducing lung cancer mortality should be obtained by combining smoking cessation and lung cancer screening.",2020,"The false positive rate is not higher than in the general population, except for cases with CD4 <200/mm 3 .","['people living with HIV', 'people living with HIV (PLHIV']","['varenicline', 'placebo', 'Low dose CT scan']","['risk of lung cancer', 'false positive rate', 'lung cancer mortality']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0205557', 'cui_str': 'False positive (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0395476,"The false positive rate is not higher than in the general population, except for cases with CD4 <200/mm 3 .","[{'ForeName': 'A-M', 'Initials': 'AM', 'LastName': 'Ruppert', 'Affiliation': 'GRC n°04, Theranoscan, faculté de médecine P&M Curie, Sorbonne université, hôpital Tenon (AP-HP), 4, rue de la Chine, 75252 Paris, France; Service de pneumologie, unité de tabacologie, hôpital Tenon, Assistance Publique-Hôpitaux de Paris, Paris, France. Electronic address: anne-marie.ruppert@aphp.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lavolé', 'Affiliation': 'GRC n°04, Theranoscan, faculté de médecine P&M Curie, Sorbonne université, hôpital Tenon (AP-HP), 4, rue de la Chine, 75252 Paris, France; Service de pneumologie, unité de tabacologie, hôpital Tenon, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Makinson', 'Affiliation': 'Département des maladies infectieuses et unité, InsermU1175, université et CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Le Maître', 'Affiliation': 'Unité de coordination de tabacologie, CHU de Caen, Caen, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cadranel', 'Affiliation': 'GRC n°04, Theranoscan, faculté de médecine P&M Curie, Sorbonne université, hôpital Tenon (AP-HP), 4, rue de la Chine, 75252 Paris, France; Service de pneumologie, unité de tabacologie, hôpital Tenon, Assistance Publique-Hôpitaux de Paris, Paris, France.'}]",Revue des maladies respiratoires,['10.1016/j.rmr.2019.08.008']
280,31742903,Evaluation of the Interaction Model of Client Health Behavior-based multifaceted intervention on patient activation and osteoarthritis symptoms.,"PURPOSE


This study evaluated a multifaceted intervention for osteoarthritis symptoms.
METHODS


A cluster randomized controlled trial was conducted with a convenience sample of 90 patients aged between 45 and 82 years, who were recruited from three Community Health Posts (CHPs). The CHPs were randomized into two experimental groups (E1 and E2) and one control group (C). The intervention included health education and counseling combined with exercise classes based on the Interaction Model of Client Health Behavior. Trained community health nurse practitioners led the intervention. Stretching exercise (E1) and walking (E2) combined with muscle strengthening exercise were provided. The instruments included the Patient Activation Measure (PAM), Korean version of the Western Ontario and McMaster Universities Osteoarthritis Index (K-WOMAC), Stanford Health Assessment Questionnaire Disability Scale (HAQDS), and Center for Epidemiologic Studies Depression Scale (CES-D). The HAQDS was measured using an ordinal scale, and Likert scales were used for the other instruments. Chi-square test and analysis of covariance were used; P values <.05 were considered significant. The study was conducted in 2014.
RESULTS


The groups were similar at the baseline (P > .05) except for joint pain and patient activation (P < .05). At post-test, the changes in the mean scores were significant for joint pain and stiffness, and physical functioning. E2 with walking exercise showed better improvements in joint pain and physical functioning than the other groups (P < .01).
CONCLUSIONS


Eight sessions of multifaceted intervention improved the osteoarthritis symptoms. Follow-up studies will be needed to determine the intermediate and long-term effects of the multifaceted intervention.",2020,"E2 with walking exercise showed better improvements in joint pain and physical functioning than the other groups (P < .01).
","['Trained community health nurse practitioners', 'convenience sample of 90 patients aged between 45 and 82\u2009years, who were recruited from three Community Health Posts (CHPs']","['multifaceted intervention', 'E2 with walking exercise', 'health education and counseling combined with exercise classes based on the Interaction Model of Client Health Behavior', 'Stretching exercise (E1) and walking (E2) combined with muscle strengthening exercise', 'Client Health Behavior-based multifaceted intervention']","['joint pain and patient activation', 'osteoarthritis symptoms', 'Patient Activation Measure (PAM), Korean version of the Western Ontario and McMaster Universities Osteoarthritis Index (K-WOMAC), Stanford Health Assessment Questionnaire Disability Scale (HAQDS), and Center for Epidemiologic Studies Depression Scale (CES-D', 'joint pain and physical functioning', 'HAQDS', 'patient activation and osteoarthritis symptoms', 'joint pain and stiffness, and physical functioning']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C1522710', 'cui_str': 'Nurses, Community Health'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018701'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0454306', 'cui_str': 'Exercise class (regime/therapy)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0018687'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]","[{'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4075707', 'cui_str': 'PAM - Patient Activation Measure'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}]",90.0,0.0364966,"E2 with walking exercise showed better improvements in joint pain and physical functioning than the other groups (P < .01).
","[{'ForeName': 'Yang Heui', 'Initials': 'YH', 'LastName': 'Ahn', 'Affiliation': 'Department of Nursing, Yonsei University Wonju College of Medicine, Wonju, South Korea.'}, {'ForeName': 'Ok Kyung', 'Initials': 'OK', 'LastName': 'Ham', 'Affiliation': 'Department of Nursing, Inha University, Incheon, South Korea.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12306']
281,31746139,The effects of self-performance management video program on patients receiving hemodialysis.,"AIM


This study attempted to investigate the effects of a self-performance management video program using a tablet PC on self-care knowledge, self-care behavior, state anxiety and physiological index in patients receiving hemodialysis.
METHODS


This study was an experimental research design. The participants of this study were 46 patients who were diagnosed with end-stage renal failure and received hemodialysis on a regular basis in kidney centers (23: experimental group, 23: control group). The data collection period was from November 24, 2016 to January 3, 2017. The program was designed and organized by the researchers of this study according to previous studies consisting of six categories in a total 70-min video program. The contents of the self-performance management program were stored on the tablet PC, so that the patients were self-led. All the patients who participated in the program were asked to complete three categories in a week. Therefore, it took 2 weeks to complete all contents of the six categories. After that, the patients were asked to repeat the 2-week course twice. Therefore, the program was carried out for a total of 6 weeks. For the control group, a pamphlet was used.
RESULTS


The anxiety of the experimental group was significantly decreased compared to the control group. Among the physiological index, potassium and albumin levels were statistically significant.
CONCLUSIONS


The self-performance management video program using a tablet PC developed in this study seems to be applicable to patients receiving hemodialysis who need anxiety and physiological index management.",2020,The anxiety of the experimental group was significantly decreased compared to the control group.,"['patients receiving hemodialysis', '46 patients who were diagnosed with end-stage renal failure and received hemodialysis on a regular basis in kidney centers (23: experimental group, 23: control group', 'patients receiving hemodialysis who need anxiety and physiological index management']",['self-performance management video program'],"['self-care knowledge, self-care behavior, state anxiety and physiological index', 'physiological index, potassium and albumin levels', 'anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0428519', 'cui_str': 'Albumin level - finding'}]",46.0,0.0149369,The anxiety of the experimental group was significantly decreased compared to the control group.,"[{'ForeName': 'Hyeyoung', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'Department of Nursing, Kunsan National University, Geonbuk, Republic of Korea.'}, {'ForeName': 'Sunghee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Nursing, Kunsan National University, Geonbuk, Republic of Korea.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12303']
282,31517773,Effects of prophylactic iron supplementation on outcome of nonanemic pregnant women: A non-randomized clinical trial.,"BACKGROUND


The aim of the current study was to investigate the effects of prophylactic iron supplementation on the pregnancy outcome of nonanemic pregnant women in a sample of Iranian population.
METHODS


This non-randomized clinical trial was conducted during a 2-year period in obstetrics clinics of Shiraz, southern Iran. We included a sample of singleton pregnancies registered in our clinics. Those with comorbidities were excluded. Serum ferritin was measured at baseline and participants were classified accordingly: those with normal serum ferritin levels (≥30 µg/dL) who received standard prophylactic iron supplementation during the pregnancy (Group 1); those who had minor thalassemia and elevated serum ferritin levels (≥30 µg/dL) who did not receive prophylactic iron supplementation or those with normal ferritin levels (≥30 µg/dL) who refused to receive iron supplementation due to gastrointestinal upset (Group 2); and those with iron deficiency anemia with low serum ferritin levels (<30 µg/dL) who received standard iron supplementation during pregnancy (Group 3). All the participants were followed to the delivery and maternal and neonatal outcomes were recorded and compared between three study groups.
RESULTS


Overall we included 30 pregnant women in each group with mean age of the participants was 28.66 ± 6.02 years. There was no significant difference between three study groups regarding gestational age at delivery (p = 0.250), birthweight (p = 0.893), Apgar at 1 (p = 0.532) and 5 (p = 0.590) minutes, and route of delivery (p = 0.590). The overall rate of maternal complication of the pregnancy was comparable between the three study groups (p = 0.188). However, those in group 1, had significantly higher rate of gestational diabetes mellitus (GDM) when compared to other two groups (p = 0.038).
CONCLUSION


Prophylactic iron supplementation in pregnant women with normal ferritin levels is associated with increased risk of GDM. Other pregnancy and neonatal outcomes are not affected by the prophylactic iron supplementation.",2019,The overall rate of maternal complication of the pregnancy was comparable between the three study groups (p=0.188).,"['Nonanemic Pregnant Women', 'singleton pregnancies registered in our clinics', 'nonanemic pregnant women in a sample of Iranian population', '30 pregnant women in each group with mean age of the participants was 28.66 ±\u20096.02 years', 'during the pregnancy (Group 1); those who had minor thalassemia and elevated serum ferritin levels (≥30 µg/dL) who did not receive', 'obstetrics clinics of Shiraz, southern Iran', 'pregnant women with normal ferritin levels']","['prophylactic iron supplementation', 'Prophylactic iron supplementation', 'Prophylactic Iron Supplementation', 'standard prophylactic iron supplementation', 'prophylactic iron supplementation or those with normal ferritin levels (≥30 µg/dL) who refused to receive iron supplementation due to gastrointestinal upset (Group 2); and those with iron deficiency anemia with low serum ferritin levels (<30 µg/dL) who received standard iron supplementation']","['overall rate of maternal complication of the pregnancy', 'rate of gestational diabetes mellitus', 'Serum ferritin', 'risk of gestational diabetes mellitus (GDM']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0039730', 'cui_str': 'Thalassemia'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C2697368', 'cui_str': 'Gastrointestinal irritation (disorder)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C4076066', 'cui_str': 'Serum ferritin level low (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",30.0,0.275818,The overall rate of maternal complication of the pregnancy was comparable between the three study groups (p=0.188).,"[{'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kasraeian', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sedigeh', 'Initials': 'S', 'LastName': 'Yoosefi', 'Affiliation': 'Perinatology Division, Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Faraji', 'Affiliation': 'Perinatology Division, Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Abbasi', 'Affiliation': 'Department of Obstetrics and Gynecology, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of the Chinese Medical Association : JCMA,['10.1097/JCMA.0000000000000184']
283,31864574,"Autologous Bone Graft Versus Silicate-Substituted Calcium Phosphate in the Treatment of Tunnel Defects in 2-Stage Revision Anterior Cruciate Ligament Reconstruction: A Prospective, Randomized Controlled Study With a Minimum Follow-up of 2 Years.","PURPOSE


To compare and evaluate knee laxity and functional outcomes between autologous bone graft and silicate-substituted calcium phosphate (Si-CaP) in the treatment of tunnel defects in 2-stage revision anterior cruciate ligament reconstruction (ACLR).
METHODS


This prospective, randomized controlled trial was conducted between 2012 and 2015 with a total of 40 patients who underwent 2-stage revision ACLR. The tunnels were filled with autologous iliac crest cancellous bone graft in 20 patients (control group) and with Si-CaP in the other 20 patients (intervention group). After a minimum follow-up period of 2 years, functional outcomes were assessed by KT-1000 arthrometry (side-to-side [STS] difference), the Tegner score, the Lysholm score, and the International Knee Documentation Committee score.
RESULTS


A total of 37 patients (follow-up rate, 92.5%) with an average age of 31 years were followed up for 3.4 years (range, 2.2-5.5 years). The KT-1000 measurement did not show any STS difference between the bone graft group (0.9 ± 1.5 mm) and the Si-CaP group (0.7 ± 2.0 mm) (P = .731). One patient in the intervention group (5%) had an STS difference greater than 5 mm. Both groups showed significant improvements in the Tegner score, Lysholm score, and International Knee Documentation Committee score from preoperative assessment to final follow-up (P ≤ .002), without any difference between the 2 groups (P ≥ .396). Complications requiring revision occurred in 4 control patients (22%) and in 2 patients in the intervention group (11%) (P = .660). No complications in relation to Si-CaP were observed.
CONCLUSIONS


Equivalent knee laxity and clinical function outcomes were noted 3 years after surgery in both groups of patients. Si-CaP bone substitute is therefore a safe alternative to autologous bone graft for 2-stage ACLR.
LEVEL OF EVIDENCE


Level I, prospective, randomized controlled clinical trial.",2020,"Both groups showed significant improvements in the Tegner score, Lysholm score, and International Knee Documentation Committee score from preoperative assessment to final follow-up (P ≤ .002), without any difference between the 2 groups (P ≥ .396).","['37 patients (follow-up rate, 92.5%) with an average age of 31\xa0years were followed up for 3.4\xa0years (range, 2.2-5.5\xa0years', 'tunnel defects in 2-stage revision anterior cruciate ligament reconstruction (ACLR', '2012 and 2015 with a total of 40 patients who underwent 2-stage revision ACLR', '2-Stage Revision Anterior Cruciate Ligament Reconstruction']","['autologous bone graft and silicate-substituted calcium phosphate (Si-CaP', 'Si-CaP bone substitute', 'Si-CaP', 'autologous iliac crest cancellous bone graft', 'Autologous Bone Graft Versus Silicate-Substituted Calcium Phosphate']","['Tegner score, Lysholm score, and International Knee Documentation Committee score', 'Equivalent knee laxity and clinical function outcomes', 'Si-CaP', 'Complications requiring revision', 'Tegner score, the Lysholm score, and the International Knee Documentation Committee score', 'Tunnel Defects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517692', 'cui_str': '3.4 (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0559715', 'cui_str': 'Staged revision (qualifier value)'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C1699650', 'cui_str': 'Autologous bone graft'}, {'cui': 'C0086983', 'cui_str': 'Silicates'}, {'cui': 'C0006711', 'cui_str': 'calcium phosphate'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0243003', 'cui_str': 'Bone Replacement Materials'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0223651', 'cui_str': 'Iliac Crest'}, {'cui': 'C0222660', 'cui_str': 'Spongy Bone'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0332536', 'cui_str': 'Laxness'}, {'cui': 'C0422813', 'cui_str': 'Clinical function (finding)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C0243067', 'cui_str': 'defects'}]",,0.10047,"Both groups showed significant improvements in the Tegner score, Lysholm score, and International Knee Documentation Committee score from preoperative assessment to final follow-up (P ≤ .002), without any difference between the 2 groups (P ≥ .396).","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'von Recum', 'Affiliation': 'Department for Trauma and Orthopaedic Surgery, BG Trauma Center Ludwigshafen, University of Heidelberg, Ludwigshafen on the Rhine, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Gehm', 'Affiliation': 'Department for Trauma and Orthopaedic Surgery, BG Trauma Center Ludwigshafen, University of Heidelberg, Ludwigshafen on the Rhine, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Guehring', 'Affiliation': 'Department for Shoulder and Elbow Surgery, Arcus Clinic Pforzheim, Pforzheim, Germany.'}, {'ForeName': 'Sven Y', 'Initials': 'SY', 'LastName': 'Vetter', 'Affiliation': 'Department for Trauma and Orthopaedic Surgery, BG Trauma Center Ludwigshafen, University of Heidelberg, Ludwigshafen on the Rhine, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'von der Linden', 'Affiliation': 'Department for Trauma and Orthopaedic Surgery, BG Trauma Center Ludwigshafen, University of Heidelberg, Ludwigshafen on the Rhine, Germany.'}, {'ForeName': 'Paul-Alfred', 'Initials': 'PA', 'LastName': 'Grützner', 'Affiliation': 'Department for Trauma and Orthopaedic Surgery, BG Trauma Center Ludwigshafen, University of Heidelberg, Ludwigshafen on the Rhine, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Schnetzke', 'Affiliation': 'Department for Trauma and Orthopaedic Surgery, BG Trauma Center Ludwigshafen, University of Heidelberg, Ludwigshafen on the Rhine, Germany. Electronic address: marcschnetzke@gmx.de.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2019.07.035']
284,31965675,Effectiveness of behaviour change techniques on lifestyle interventions of patients with a high risk of developing cardiovascular disease. Using a qualitative approach.,"This study aimed to identify key active ingredients on the maintenance of behaviour change for lifestyle interventions of patients with a high risk of developing cardiovascular disease (CVD) who participated in a MOtiVational intErviewing InTervention (MOVE IT) randomised control trial (RCT). A process evaluation was carried out using focus groups. Twenty-six participants of the MOVE IT RCT were purposively recruited and split into six focus groups. Four groups had attended six or more sessions of the intensive phase (completers) and two groups had withdrawn before the end of the intensive phase or had not attended any sessions (non-completers). Focus groups were audio recorded, transcribed verbatim and analysed inductively using thematic analysis. Three overall themes were generated from the six focus groups: (a) long-term benefits from diet and physical activity education, (b) group versus individual structure and adherence and (c) impact on health beliefs and risk of CVD. A fourth theme was generated from the two groups of non-completers only: (d) need for professional rapport building and feedback. We found that the key active ingredients for effective behavioural change in lifestyle interventions are having well-developed rapport between facilitators and patients; and providing alternative forms of feedback to encourage maintenance of behaviour change. Furthermore, such programmes also need to have established and strong relationships with associated health professionals (i.e. the General Practitioner) to increase participation and maintenance of engagement.",2020,We found that the key active ingredients for effective behavioural change in lifestyle interventions are having well-developed rapport between facilitators and patients; and providing alternative forms of feedback to encourage maintenance of behaviour change.,"['Twenty-six participants of the MOVE IT RCT', 'Four groups had attended six or more sessions of the intensive phase (completers) and two groups had withdrawn before the end of the intensive phase or had not attended any sessions (non-completers', 'patients with a high risk of developing cardiovascular disease (CVD) who participated in a MOtiVational intErviewing InTervention (MOVE IT) randomised control trial (RCT', 'patients with a high risk of developing cardiovascular disease']",['behaviour change techniques'],['health beliefs and risk of CVD'],"[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0559294', 'cui_str': 'Not attended'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0814098', 'cui_str': 'Health belief'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",26.0,0.0302038,We found that the key active ingredients for effective behavioural change in lifestyle interventions are having well-developed rapport between facilitators and patients; and providing alternative forms of feedback to encourage maintenance of behaviour change.,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kuriakose', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Kuczynska', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Timpel', 'Affiliation': 'Department for Prevention and Care of Diabetes, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Yakub', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bayley', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Iliatha', 'Initials': 'I', 'LastName': 'Papachristou Nadal', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",Health & social care in the community,['10.1111/hsc.12933']
285,32227624,Brief mindfulness session improves mood and increases salivary oxytocin in psychology students.,"Mindfulness-based interventions (MBI) have been shown to be effective in increasing empathy in health professionals. Yet, more research is needed to analyse the specific influence of mindfulness exercises on biological variables involved in empathy, such as the biological system of oxytocin activity. In this study, we analyse the effects of a brief mindfulness session on positive and negative affect, state anxiety and salivary oxytocin (sOXT) in psychology students (N = 68). In the experimental group (n = 42), a mindfulness session was performed that included different guided meditation exercises. In the control group (n = 26), an emotion recognition exercise was carried out, along with a series of creative activities. Results showed that the mindfulness session was effective, because there was a significant reduction in negative affect (d = -.56, p < .001) and state anxiety (d = -.54, p = .007) in the experimental group. Likewise, there was an increase in sOXT (d = .99, p < .001) in this group, compared with the control group. Guided mindfulness meditation practice could be useful to reach an emotional and biological state that facilitates empathy. In this regard, the increase in sOXT after the mindfulness session adds further evidence about the biological mechanisms underlying the benefits of MBI on empathy.",2020,"In the experimental group (n = 42), a mindfulness session was performed that included different guided meditation exercises.",['psychology students'],"['brief mindfulness session', 'mindfulness session was performed that included different guided meditation exercises', 'Guided mindfulness meditation practice', 'Brief mindfulness session', 'Mindfulness-based interventions (MBI', 'emotion recognition exercise']","['state anxiety ', 'positive and negative affect, state anxiety and salivary oxytocin (sOXT', 'sOXT', 'salivary oxytocin']","[{'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0150277'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",,0.0158836,"In the experimental group (n = 42), a mindfulness session was performed that included different guided meditation exercises.","[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Bellosta-Batalla', 'Affiliation': 'Department of Psychobiology, University of Valencia, Valencia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Del Carmen Blanco-Gandía', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza, Teruel, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Rodríguez-Arias', 'Affiliation': 'Department of Psychobiology, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Ausiàs', 'Initials': 'A', 'LastName': 'Cebolla', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment. University of Valencia, Valencia, Spain.'}, {'ForeName': 'Josefa', 'Initials': 'J', 'LastName': 'Pérez-Blasco', 'Affiliation': 'Department of Evolutionary and Educational Psychology, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Moya-Albiol', 'Affiliation': 'Department of Psychobiology, University of Valencia, Valencia, Spain.'}]",Stress and health : journal of the International Society for the Investigation of Stress,['10.1002/smi.2942']
286,31374368,Physical Activity for Symptom Management in Women With Metastatic Breast Cancer: A Randomized Feasibility Trial on Physical Activity and Breast Metastases.,"CONTEXT


Physical activity for women with early-stage breast cancer is well recognized for managing cancer-related symptoms and improving quality of life. While typically excluded from interventions, women with metastatic breast cancer may also benefit from physical activity.
OBJECTIVE


To 1) determine the safety and feasibility of a physical activity program for women with metastatic breast cancer and 2) explore the efficacy of the program.
METHODS


Fourteen women with metastatic breast cancer were randomized to either a control group or an 8-week home-based physical activity intervention comprising twice weekly supervised resistance training and an unsupervized walking program.
RESULTS


The recruitment rate was 93%. Adherence to the resistance and walking components of the program was 100% and 25%, respectively. No adverse events were reported. When mean change scores from baseline to postintervention were compared, trends in favor of the exercise group over the control group were observed for the Functional Assessment of Chronic Illness Therapy-Fatigue score (+5.6 ± 3.2 vs. -1.8 ± 3.9, respectively), VO 2max  (+1.6 ml/kg/minute ±1.8 mL/kg/minute vs. -0.2 mL/kg/minute ±0.1 mL/kg/minute, respectively) and six-minute walk test (+40 m ± 23 m vs. -46 m ± 56 m, respectively).
CONCLUSION


A partially supervised home-based physical activity program for women with metastatic breast cancer is feasible and safe. The dose of the resistance training component was well tolerated and achievable in this population. In contrast, adherence and compliance to the walking program were poor. Preliminary data suggest a physical activity program, comprising predominantly resistance training, may lead to improvements in physical capacity and may help women to live well with their disease.",2019,No adverse events were reported.,"['women with metastatic breast cancer and 2', 'women with early-stage breast cancer', 'Fourteen women with metastatic breast cancer', 'Women With Metastatic Breast Cancer', 'women with metastatic breast cancer']","['supervised home-based physical activity program', 'control group or an 8-week home-based physical activity intervention comprising twice weekly supervised resistance training and an unsupervized walking program', 'physical activity program']","['Physical Activity', 'adverse events', 'Functional Assessment of Chronic Illness Therapy-Fatigue score', 'recruitment rate']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]",14.0,0.040837,No adverse events were reported.,"[{'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Yee', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, Australia.'}, {'ForeName': 'Glen M', 'Initials': 'GM', 'LastName': 'Davis', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hackett', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, Australia.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Beith', 'Affiliation': ""The Chris O'Brien Lifehouse, Camperdown, Australia.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Wilcken', 'Affiliation': 'Crown Princess Mary Cancer Centre, Westmead Hospital, The University of Sydney, Lidcombe, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Currow', 'Affiliation': 'Faculty of Health Sciences, Flinders University, Daw Park, Australia.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Emery', 'Affiliation': 'General Practice and Primary Care Academic Centre, University of Melbourne, Parkville, Australia; General Practice, University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Faculty of Health, University of Technology Sydney, Ultimo, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Clinical Trials Centre, University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Hui', 'Affiliation': 'Crown Princess Mary Cancer Centre, Westmead Hospital, The University of Sydney, Lidcombe, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Harrison', 'Affiliation': ""The Chris O'Brien Lifehouse, Camperdown, Australia.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Segelov', 'Affiliation': 'Monash Health and Monash University, Melbourne, Australia.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Kilbreath', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, Australia. Electronic address: sharon.kilbreath@sydney.edu.au.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.07.022']
287,31404644,"A Randomized, Double-Blind, Multisite, Pilot, Placebo-Controlled Trial of Regular, Low-Dose Morphine on Outcomes of Pulmonary Rehabilitation in COPD.",,2019,,['pulmonary rehabilitation in COPD'],"['morphine', 'placebo']",[],"[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.621539,,"[{'ForeName': 'Slavica', 'Initials': 'S', 'LastName': 'Kochovska', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia; Australian National Palliative Clinical Studies Collaborative, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Fazekas', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia; Australian National Palliative Clinical Studies Collaborative, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hensley', 'Affiliation': 'University of Newcastle, John Hunter Hospital, Newcastle, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wheatley', 'Affiliation': 'University of Sydney at Westmead Hospital, New South Wales, Australia; Ludwig Engel Centre for Respiratory Research, The Westmead Institute for Medical Research, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Allcroft', 'Affiliation': 'Australian National Palliative Clinical Studies Collaborative, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia; Flinders University, Flinders Drive, Bedford Park, South Australia, Australia.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia; Australian National Palliative Clinical Studies Collaborative, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia; Wolfson Palliative Care Research Centre, University of Hull, Hull, England. Electronic address: david.currow@uts.edu.au.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.07.026']
288,32236530,Effect of an Intervention in General Practice to Increase the Participation of Immigrants in Cervical Cancer Screening: A Cluster Randomized Clinical Trial.,"Importance


Immigrant women have lower participation in cervical cancer screening (CCS) programs. At the same time, some groups of immigrants have higher prevalence of cervical cancer. Targeted interventions are therefore necessary.
Objective


To determine whether an intervention among general practitioners (GPs) could influence immigrant women's participation in the Norwegian CCS program.
Design, Setting, and Participants


Cluster-randomized clinical trial using the 20 subdistricts of the Bergen, Norway, municipality as clusters. The clusters were matched in 10 pairs according to the number of immigrant women living in them and randomized thereafter. The intervention was implemented between January and June 2017 among urban, primary care, general practices in Bergen. Follow-up ended in January 2018. General practices belonging to the control areas continued treatment as usual. A total of 10 360 women who attended 73 general practices in the 20 subdistricts were included as participants.
Intervention


The intervention consisted of 3 elements: an educational session for GPs at lunch describing the importance of CCS among immigrants and giving advice about how to invite them to participate, a mouse pad as a reminder, and a poster placed in waiting rooms. In the educational session, we elaborated the need for GPs to ask every immigrant woman about CCS, regardless of their reason for contacting their GP.
Main Outcomes and Measures


The main outcome, screening status of immigrant women by January 1, 2018, was obtained from the Norwegian Cancer Registry. The effect of the intervention was measured as odds ratio (OR) for CCS status as of January 1, 2018, for the intervention group vs the control group, with 3 levels of adjustments: baseline CCS status at January 1, 2017 (model 1), additional adjustment for women's age, marital status, income level, and region of origin (model 2), and further adjustment for the GP's sex, age, and region of origin (model 3). Two subgroup analyses, screening status at baseline and women's country of origin, were conducted to assess whether these factors had any influence on the effect of the intervention. Data were analyzed as intention to treat.
Results


A total of 10 360 immigrant women, 5227 (50.4%; mean [SD] age, 44.0 [12.0] years) in the intervention group and 5133 (49.6%; mean [SD] age, 44.5 [11.6] years) in the control group, belonging to 39 general practices in the intervention area and 34 in the control area, were included in the study. The proportion of immigrant women screened increased by 2.6% in the intervention group and 0.6% in the control group. After adjustment for screening status at baseline, women in the intervention group were more likely to have participated in CCS (OR, 1.24 [95% CI, 1.11-1.38]). This statistically significant effect remained unchanged after adjustment for women's characteristics (OR, 1.24 [95% CI, 1.11-1.38]) and was reduced, but still significant, after further adjustment for GP characteristics (OR, 1.19 [95% CI, 1.06-1.34]). In subgroup analyses, the intervention particularly increased participation among women who were not previously screened at baseline (OR, 1.35 [95% CI, 1.16-1.56]), and those from Poland, Pakistan, and Somalia (OR, 1.74 [95% CI, 1.17-2.61]) when adjusting for baseline screening status.
Conclusions and Relevance


Our intervention targeting general practices significantly increased CCS participation among immigrants, although the absolute effect size of 2% in the fully adjusted model was small. Engaging other primary health professionals such as midwives to perform CCS could further contribute to increasing participation.
Trial Registration


ClinicalTrials.gov Identifier: NCT03155581.",2020,The proportion of immigrant women screened increased by 2.6% in the intervention group and 0.6% in the control group.,"['Immigrants in Cervical Cancer Screening', ""women's age, marital status, income level, and region of origin (model 2), and further adjustment for the GP's sex, age, and region of origin (model 3"", ""general practitioners (GPs) could influence immigrant women's participation in the Norwegian CCS program"", 'A total of 10\u202f360 immigrant women, 5227 (50.4%; mean [SD] age, 44.0 [12.0] years) in the intervention group and 5133 (49.6%; mean [SD] age, 44.5 [11.6] years) in the control group, belonging to 39 general practices in the intervention area and 34 in the control area, were included in the study', 'A total of 10\u202f360 women who attended 73 general practices in the 20 subdistricts were included as participants']","['educational session for GPs at lunch describing the importance of CCS among immigrants and giving advice about how to invite them to participate, a mouse pad as a reminder, and a poster placed in waiting rooms']","['odds ratio (OR) for CCS status', 'CCS participation']","[{'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0024819', 'cui_str': 'Marital status'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",10360.0,0.132129,The proportion of immigrant women screened increased by 2.6% in the intervention group and 0.6% in the control group.,"[{'ForeName': 'Kathy Ainul', 'Initials': 'KA', 'LastName': 'Møen', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Kumar', 'Affiliation': 'Unit for Migration and Health, Norwegian Institute of Public Health (FHI), Oslo, Norway.'}, {'ForeName': 'Jannicke', 'Initials': 'J', 'LastName': 'Igland', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Diaz', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.1903']
289,32236533,Effect of Intensivist Communication in a Simulated Setting on Interpretation of Prognosis Among Family Members of Patients at High Risk of Intensive Care Unit Admission: A Randomized Trial.,"Importance


Discordance about prognosis between a patient's health care decision-making surrogate and the treating intensivist is common in the intensive care unit (ICU). Empowering families, friends, and caregivers of patients who are critically ill to make informed decisions about care is important, but it is unclear how best to communicate prognostic information to surrogates when a patient is expected to die.
Objective


To determine whether family members, who are often health care decision-making surrogates, interpret intensivists as being more optimistic when questions about prognosis in the ICU are answered indirectly.
Design, Setting, and Participants


This web-based randomized trial was conducted between September 27, 2019, and October 17, 2019, among a national sample of adult children, spouses, partners, or siblings of people with chronic obstructive pulmonary disease who were receiving long-term oxygen therapy. Participants were shown video vignettes depicting an intensivist answering a standardized question about the prognosis of a patient at high risk of death on day 3 of ICU admission. Participants were excluded if they had worked as a physician, nurse, or advanced health care practitioner. Data were analyzed from October 18, 2019, to November 12, 2019.
Interventions


Participants were randomized to view 1 of 4 intensivist communication styles in response to the question ""What do you think is most likely to happen?"": (1) a direct response (control), (2) an indirect response comparing the patient's condition with that of other patients, (3) an indirect response describing the patient's deteriorating physiological condition, or (4) redirection to a discussion of the patient's values and goals.
Main Outcomes and Measures


Participant responses to 2 questions: (1) ""If you had to guess, what do you think the doctor thinks is the chance that your loved one will survive this hospitalization?"" and (2) ""What do you think are the chances that your loved one will survive this hospitalization?"" answered using a 0% to 100% probability scale.
Results


Among 302 participants (median [interquartile range] age, 49 [38-59] years; 204 [68%] women) included in the trial, 165 (55%) were adult children of the individual with chronic obstructive pulmonary disease; 77 participants were randomized to view a direct response, 77 participants were randomized to view an indirect response referencing other patients, 68 participants were randomized to view an indirect response referencing physiological condition, and 80 participants were randomized to view a redirection response. Compared with participants who viewed a direct response, participants who viewed an indirect response referencing other patients (β = 10 [95% CI, 1-19]; P = .03), physiological condition (β = 10 [95% CI, 0-19]; P = .04), or redirection to a discussion of the patient's values and goals (β = 19 [95% CI, 10-28]; P < .001) perceived the intensivist to have a significantly more optimistic prognostic estimate.
Conclusions and Relevance


These findings suggest that family members interpret indirect or redirection responses to questions about prognosis in the ICU setting as more optimistic than direct responses.
Trial Registration


ClinicalTrials.gov Identifier: NCT04239209.",2020,"Compared with participants who viewed a direct response, participants who viewed an indirect response referencing other patients (β = 10 [95% CI, 1-19]; P = .03), physiological condition (β = 10 [95% CI, 0-19]; P = .04), or redirection to a discussion of the patient's values and goals (β = 19 [95% CI, 10-28]; P < .001) perceived the intensivist to have a significantly more optimistic prognostic estimate.
","['Participants were excluded if they had worked as a physician, nurse, or advanced health care practitioner', 'Participants\n\n\nThis web-based randomized trial was conducted between September 27, 2019, and October 17, 2019, among a national sample of adult children, spouses, partners, or siblings of people with chronic obstructive pulmonary disease who were receiving long-term oxygen therapy', 'Family Members of Patients at High Risk of Intensive Care Unit Admission', '302 participants (median [interquartile range] age, 49 [38-59] years; 204 [68%] women) included in the trial, 165 (55%) were adult children of the individual with chronic obstructive pulmonary disease; 77 participants were randomized to view a direct response, 77 participants were randomized to view an indirect response referencing other patients, 68 participants were randomized to view an indirect response referencing physiological condition, and 80 participants']","['Intensivist Communication', ""indirect response describing the patient's deteriorating physiological condition, or (4) redirection to a discussion of the patient's values and goals""]","['optimistic prognostic estimate', 'Main Outcomes and Measures\n\n\nParticipant responses to 2 questions: (1) ']","[{'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0683572', 'cui_str': 'Children, Adult'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0418996', 'cui_str': 'Long-term oxygen therapy'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]","[{'cui': 'C0564470', 'cui_str': 'Optimistic'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",165.0,0.20929,"Compared with participants who viewed a direct response, participants who viewed an indirect response referencing other patients (β = 10 [95% CI, 1-19]; P = .03), physiological condition (β = 10 [95% CI, 0-19]; P = .04), or redirection to a discussion of the patient's values and goals (β = 19 [95% CI, 10-28]; P < .001) perceived the intensivist to have a significantly more optimistic prognostic estimate.
","[{'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Oppenheim', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Vasher', 'Affiliation': 'Department of Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Zaeh', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Joanna L', 'Initials': 'JL', 'LastName': 'Hart', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Alison E', 'Initials': 'AE', 'LastName': 'Turnbull', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.1945']
290,32236953,Investigation and Management of Stool Frequency and Consistency Associated With SGLT1 Inhibition by Reducing Dietary Carbohydrate: A Randomized Trial.,"Treatment with licogliflozin, a dual sodium-glucose co-transporter (SGLT)1/2-inhibitor, is associated with increased stool frequency and loose stools, attributed to SGLT1 inhibition. To investigate the effect of carbohydrate content and supplements on licogliflozin-induced stools, a randomized, open-label, two-part (N = 24/part), three-period crossover study was carried out in overweight or obese adults. Significantly higher (P < 0.01) change from baseline in 3-day total number of bowel movements was observed following 3 days of licogliflozin treatment (50 mg q.d.) together with a 50% carbohydrate meal compared with a 25% and 0% carbohydrate meal. The number of stools with Bristol Stool Chart score of 6 or 7 was also significantly lower following a 0% carbohydrate meal. Supplementation with psyllium 6 g or calcium carbonate 1 g had no effect on stool changes following treatment. Licogliflozin was generally safe and well-tolerated. Loose stool associated with licogliflozin treatment and ingestion of meals can be managed by reducing the carbohydrate content of meals taken with licogliflozin.",2020,Significantly higher (p<0.01) change from baseline in three-day total number of bowel movements was observed following three days of licogliflozin treatment (50 mg q.d.) together with a 50% carbohydrate meal compared to a 25% and 0% carbohydrate meal.,['overweight or obese adults'],"['licogliflozin', 'psyllium 6g or calcium carbonate', 'Licogliflozin', 'carbohydrate content and supplements']","['total number of bowel movements', 'number of stools with BSC score', 'stool changes', 'safe and well tolerated', 'stool frequency and loose stools']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0033979', 'cui_str': 'Psyllium'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.0314963,Significantly higher (p<0.01) change from baseline in three-day total number of bowel movements was observed following three days of licogliflozin treatment (50 mg q.d.) together with a 50% carbohydrate meal compared to a 25% and 0% carbohydrate meal.,"[{'ForeName': 'YanLing', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Jül', 'Initials': 'J', 'LastName': 'Schofield', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Mahling', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Anisha E', 'Initials': 'AE', 'LastName': 'Mendonza', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hinder', 'Affiliation': 'Novartis Institutes for BioMedical Research, Basel, Switzerland.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1840']
291,31253425,Assessing a modified fitting approach for improved multifocal contact lens fitting.,"PURPOSE


To compare the effectiveness of a modified and previous fitting guide for multifocal (MF) contact lenses that share a common optical design, lotrafilcon B, nelfilcon A, and delefilcon A, in current soft contact lens (CL) wearers needing presbyopia correction.
METHODS


This international multicenter, prospective, randomized, subject-masked study assessed the superiority of the modified guide relative to the previous guide as determined by the number of MF CLs needed to successfully fit each eye at the screening/fitting visit.
RESULTS


A total of 183 presbyopic subjects were randomized to fitting using the modified (n = 99) and previous (n = 84) MF CL fitting guides. The mean ± SD numbers of lenses required to fit each eye at the screening/fitting visit using the modified and previous fitting guides were 1.2 ± 0.5 and 1.4 ± 0.5, respectively. The least-squares mean difference (0.2) met predetermined criteria for superiority of the modified fitting guide. At the screening/fitting visit, 82.8% (164/108) and 65.1% (105/166) of presbyopic eyes were fit with one pair of MF lenses using the modified and previous guides, respectively, and 98.0% (194/198) of eyes were fit with 1-2 pairs of MF lenses using the modified guide. A higher percentage of eye care practitioners gave the highest ratings for ease of fit for the modified than for the previous fitting guide (63.6% [7/11] vs 33.3% [3/9]).
CONCLUSIONS


The modified fitting guide was superior at reducing the number of MF lenses required to successfully fit each presbyopic patient.",2019,"A higher percentage of eye care practitioners gave the highest ratings for ease of fit for the modified than for the previous fitting guide (63.6% [7/11] vs 33.3% [3/9]).
",['183 presbyopic subjects'],['modified and previous fitting guide for multifocal (MF) contact lenses'],['number of MF lenses'],"[{'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}]","[{'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205292', 'cui_str': 'Multifocal (qualifier value)'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0023318', 'cui_str': 'Lenses'}]",183.0,0.0311925,"A higher percentage of eye care practitioners gave the highest ratings for ease of fit for the modified than for the previous fitting guide (63.6% [7/11] vs 33.3% [3/9]).
","[{'ForeName': 'Mohinder', 'Initials': 'M', 'LastName': 'Merchea', 'Affiliation': 'Alcon Research, LLC., Fort Worth, TX, USA. Electronic address: mo.merchea@alcon.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Evans', 'Affiliation': 'Total Eye Care, Memphis, TN, USA.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Kannarr', 'Affiliation': 'Kannarr Eye Care, Pittsburg, KS, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'EyeCare Professionals of Powell, Powell, OH, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kaplan', 'Affiliation': 'Eye Care Clinic, Ontario, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Nixon', 'Affiliation': 'BBR Optometry, Hereford, UK.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2019.06.006']
292,31864579,Fatigue Increases Dynamic Knee Valgus in Youth Athletes: Results From a Field-Based Drop-Jump Test.,"PURPOSE


To determine whether fatigue increases dynamic knee valgus in adolescent athletes, as measured after a standardized exercise protocol and video-based drop-jump test. A secondary aim was to determine whether individual risk factors place certain athletes at increased risk for dynamic knee valgus.
METHODS


Athletes aged 14 to 18 years were recruited for this video analysis study. Athletes were recorded performing a standard drop-jump to assess dynamic valgus. Participants then completed a standardized exercise protocol. Fatigue was quantified using a maximum vertical jump, which was compared with pre-exercise values. The drop-jump was repeated postexercise. All drop-jump recordings were randomized and scored for dynamic valgus by 11 blinded reviewers. Univariate analysis was performed to identify characteristics that predisposed athletes to increased dynamic valgus.
RESULTS


Eighty-five (47 female, 38 male) athletes with an average age of 15.4 years were included in this study. Forty-nine percent of athletes demonstrated an increase in dynamic valgus determined by drop-jump assessment after exercise. A significantly greater percentage of athletes were graded ""medium or high risk"" in jumps recorded after the exercise protocol (68%) as compared with before the exercise protocol (44%; P < .01). Female athletes (P < .01) and those older than 15 years of age (P < .01) were the most affected by fatigue.
CONCLUSIONS


In conclusion, our study found that exercise increases dynamic knee valgus in youth athletes. Female athletes and those older than 15 years of age were most significantly affected by exercise. Greater fatigue levels were found to correlate with an increase in dynamic knee valgus, which may place athletes at greater anterior cruciate ligament injury risk. The field-based exercise drop-jump test is a low-cost and reproducible screening tool to identify at-risk athletes who could possibly benefit from anterior cruciate ligament injury-prevention strategies.
LEVEL OF EVIDENCE


III, Comparative trial.",2020,"The field-based exercise drop-jump test is a low-cost and reproducible screening tool to identify at-risk athletes who could possibly benefit from anterior cruciate ligament injury-prevention strategies.
","['youth athletes', '47 female, 38 male) athletes with an average age of 15.4\xa0years', 'Athletes aged 14 to 18\xa0years', 'Eighty-five', 'adolescent athletes', 'Female athletes and those older than 15\xa0years of age', 'Youth Athletes']",['standardized exercise protocol'],"['dynamic valgus', 'dynamic knee valgus', 'Greater fatigue levels', 'Fatigue']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517579', 'cui_str': '15.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0443344', 'cui_str': 'Valgus (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",38.0,0.0769546,"The field-based exercise drop-jump test is a low-cost and reproducible screening tool to identify at-risk athletes who could possibly benefit from anterior cruciate ligament injury-prevention strategies.
","[{'ForeName': 'Mohsin S', 'Initials': 'MS', 'LastName': 'Fidai', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Kelechi R', 'Initials': 'KR', 'LastName': 'Okoroha', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Meldau', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Meta', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Vincent A', 'Initials': 'VA', 'LastName': 'Lizzio', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Borowsky', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Redler', 'Affiliation': 'Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Moutzouros', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Makhni', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan. Electronic address: emakhni1@hfhs.org.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2019.07.018']
293,31864581,Arthroscopic Suprapectoral and Open Subpectoral Biceps Tenodeses Produce Similar Outcomes: A Randomized Prospective Analysis.,"PURPOSE


To directly compare subjective and objective outcomes of arthroscopic suprapectoral biceps tenodesis (ASPBT) below the bicipital groove and open subpectoral biceps tenodesis (OSPBT) performed with interference screw fixation.
METHODS


A total of 77 patients indicated for biceps tenodesis who met the inclusion and exclusion criteria were randomized into the ASPBT and OSPBT groups. All tenodesis procedures implemented PEEK (polyether ether ketone) interference screws. Patients underwent a clinical examination that included range of motion and strength assessment at 3, 6, and 12 months postoperatively. Patients completed the American Shoulder and Elbow Surgeons (ASES) shoulder score, Single Assessment Numeric Evaluation score, and Constant score preoperatively and at 6 and 12 months postoperatively.
RESULTS


Seventy-five patients were analyzed with a mean age of 50.3 ± 10.4 years and a mean body mass index of 28.9 ± 6.3. All patients had arthroscopic evidence of biceps pathology and underwent either an ASPBT (n = 37) or OSPBT (n = 38). The surgical time was significantly greater for ASPBT than for OSPBT (16.9 ± 8.4 minutes vs 9.8 ± 3.1 minutes, P < .001). One patient underwent conversion from the ASPBT group to the OSPBT group because of shearing of a severely attenuated tendon preventing an ASPBT. No significant difference (P > .05) was found in strength or anterior shoulder pain at 3 months, 6 months, and 1 year, and no significant difference (P > .05) was found in clinical outcome scores (ASES, Constant subjective, and Single Assessment Numeric Evaluation) between the 2 groups at 6 months and 1 year. The improvement in the ASES score exceeded the minimal clinically important difference (12 points) in both groups.
CONCLUSIONS


No differences in patient-reported outcome measures, functional outcomes, or complication rates were found after ASPBT compared with OSPBT. However, the results of this investigation must be interpreted with caution because this study may be underpowered to detect statistical differences.
LEVEL OF EVIDENCE


Level I, randomized controlled trial.",2020,"No significant difference (P > .05) was found in strength or anterior shoulder pain at 3 months, 6 months, and 1 year, and no significant difference (P > .05) was found in clinical outcome scores (ASES, Constant subjective, and Single Assessment Numeric Evaluation) between the 2 groups at 6 months and 1 year.","['Seventy-five patients were analyzed with a mean age of 50.3 ± 10.4\xa0years and a mean body mass index of 28.9 ± 6.3', '77 patients indicated for biceps tenodesis who met the inclusion and exclusion criteria']","['OSPBT', 'arthroscopic suprapectoral biceps tenodesis (ASPBT) below the bicipital groove and open subpectoral biceps tenodesis (OSPBT) performed with interference screw fixation', 'ASPBT', 'Arthroscopic Suprapectoral and Open Subpectoral Biceps Tenodeses']","['surgical time', 'clinical outcome scores (ASES, Constant subjective, and Single Assessment Numeric Evaluation', 'functional outcomes, or complication rates', 'American Shoulder and Elbow Surgeons (ASES) shoulder score, Single Assessment Numeric Evaluation score, and Constant score preoperatively', 'ASES score', 'shearing of a severely attenuated tendon preventing an ASPBT', 'strength or anterior shoulder pain', 'arthroscopic evidence of biceps pathology']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1260974', 'cui_str': 'Tenodesis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1260974', 'cui_str': 'Tenodesis'}, {'cui': 'C0559884', 'cui_str': 'Bicipital groove (body structure)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]",75.0,0.0724625,"No significant difference (P > .05) was found in strength or anterior shoulder pain at 3 months, 6 months, and 1 year, and no significant difference (P > .05) was found in clinical outcome scores (ASES, Constant subjective, and Single Assessment Numeric Evaluation) between the 2 groups at 6 months and 1 year.","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Forsythe', 'Affiliation': 'Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.. Electronic address: brian.forsythe@rushortho.com.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Zuke', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic Foundation, Cleveland, Ohio, U.S.A.'}, {'ForeName': 'Avinesh', 'Initials': 'A', 'LastName': 'Agarwalla', 'Affiliation': 'Department of Orthopaedic Surgery, Westchester Medical Center, Valhalla, New York, U.S.A.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Puzzitiello', 'Affiliation': 'Department of Orthopaedic Surgery, Tufts University Medical Center, Boston, Massachusetts, U.S.A.'}, {'ForeName': 'Grant H', 'Initials': 'GH', 'LastName': 'Garcia', 'Affiliation': 'Seattle Orthopaedic Center, Seattle, Washington, U.S.A.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Cvetanovich', 'Affiliation': 'Division of Sports Medicine, Department of Orthopaedics, The Ohio State University Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Adam B', 'Initials': 'AB', 'LastName': 'Yanke', 'Affiliation': 'Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Nikhil N', 'Initials': 'NN', 'LastName': 'Verma', 'Affiliation': 'Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Romeo', 'Affiliation': 'Department of Orthopaedic Surgery, Rothman Institute, Philadelphia, Pennsylvania, U.S.A.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2019.07.009']
294,31226790,Effects of Intermittent Energy Restriction Combined with a Mediterranean Diet on Reducing Visceral Adiposity: A Randomized Active Comparator Pilot Study.,"Intermittent energy restriction combined with a Mediterranean diet (IER+MED) has shown promise to reduce body fat and insulin resistance. In the Multiethnic Cohort Adiposity Phenotype Study, Japanese Americans had the highest visceral adipose tissue (VAT) when adjusting for total adiposity. We conducted this pilot study to demonstrate feasibility and explore efficacy of following IER+MED for 12 weeks to reduce VAT among East Asians in Hawaii. Sixty volunteers (aged 35-55, BMI 25-40 kg/m 2 , VAT ≥ 90 cm 2  for men and ≥ 80 cm 2  for women) were randomized to IER+MED (two consecutive days with 70% energy restriction and 5 days euenergetic MED) or an active comparator (euenergetic Dietary Approaches to Stop Hypertension (DASH) diet). Participants and clinic staff (except dietitians) were blinded to group assignments. IER+MED had significantly larger reductions in DXA-measured VAT and total fat mass (-22.6 ± 3.6 cm 2  and -3.3 ± 0.4 kg, respectively) vs. DASH (-10.7 ± 3.5 cm 2  and -1.6 ± 0.4 kg) ( p  = 0.02 and  p  = 0.005). However, after adjusting for total fat mass, change in VAT was not statistically different between groups; whereas, improvement in alanine transaminase remained significantly greater for IER+MED vs. DASH (-16.2 ± 3.8 U/L vs. -4.0 ± 3.6 U/L, respectively,  p  = 0.02). Attrition rate was 10%, and participants adhered well to study prescriptions with no reported major adverse effect. Results demonstrate IER+MED is acceptable, lowers visceral and total adiposity among East Asian Americans, and may improve liver function more effectively than a healthful diet pattern. ClinicalTrials.gov Identifier: NCT03639350.",2019,"IER+MED had significantly larger reductions in DXA-measured VAT and total fat mass (-22.6 ± 3.6 cm 2  and -3.3 ± 0.4 kg, respectively) vs. DASH (-10.7 ± 3.5 cm 2  and -1.6 ± 0.4 kg) ( p  = 0.02 and  p  = 0.005).","['Participants and clinic staff (except dietitians', 'East Asian Americans', 'Sixty volunteers (aged 35-55, BMI 25-40 kg/m 2 , VAT ≥ 90 cm 2  for men and ≥ 80 cm 2  for women', 'East Asians in Hawaii']","['Intermittent Energy Restriction Combined with a Mediterranean Diet', 'IER+MED', 'Intermittent energy restriction combined with a Mediterranean diet (IER+MED', 'IER+MED (two consecutive days with 70% energy restriction and 5 days euenergetic MED) or an active comparator (euenergetic Dietary Approaches to Stop Hypertension (DASH) diet']","['total fat mass, change in VAT', 'alanine transaminase', 'Visceral Adiposity', 'Attrition rate', 'DXA-measured VAT and total fat mass', 'visceral and total adiposity', 'body fat and insulin resistance']","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0018619', 'cui_str': 'Hawaii'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches To Stop Hypertension Diet'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0001899', 'cui_str': 'Alanine Aminotransferase'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]",60.0,0.0679428,"IER+MED had significantly larger reductions in DXA-measured VAT and total fat mass (-22.6 ± 3.6 cm 2  and -3.3 ± 0.4 kg, respectively) vs. DASH (-10.7 ± 3.5 cm 2  and -1.6 ± 0.4 kg) ( p  = 0.02 and  p  = 0.005).","[{'ForeName': 'Chloe E', 'Initials': 'CE', 'LastName': 'Panizza', 'Affiliation': 'University of Hawaii Cancer Center, Honolulu, HI 96813, USA. CPanizza@cc.hawaii.edu.'}, {'ForeName': 'Unhee', 'Initials': 'U', 'LastName': 'Lim', 'Affiliation': 'University of Hawaii Cancer Center, Honolulu, HI 96813, USA. ULim@cc.hawaii.edu.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Yonemori', 'Affiliation': 'University of Hawaii Cancer Center, Honolulu, HI 96813, USA. KMurakam@cc.hawaii.edu.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Cassel', 'Affiliation': 'University of Hawaii Cancer Center, Honolulu, HI 96813, USA. kevin@cc.hawaii.edu.'}, {'ForeName': 'Lynne R', 'Initials': 'LR', 'LastName': 'Wilkens', 'Affiliation': 'University of Hawaii Cancer Center, Honolulu, HI 96813, USA. Lynne@cc.hawaii.edu.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Harvie', 'Affiliation': 'Prevent Breast Cancer Research Unit, Manchester University Hospital Foundation, National Health Service Trust, Wythenshawe, Manchester M23 9LT, UK. michelle.harvie@manchester.ac.uk.'}, {'ForeName': 'Gertraud', 'Initials': 'G', 'LastName': 'Maskarinec', 'Affiliation': 'University of Hawaii Cancer Center, Honolulu, HI 96813, USA. Gertraud@cc.hawaii.edu.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Delp', 'Affiliation': 'School of Electrical and Computer Engineering, Purdue University, West Lafayette, IN 47907-2025, USA. ace@ecn.purdue.edu.'}, {'ForeName': 'Johanna W', 'Initials': 'JW', 'LastName': 'Lampe', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA. jlampe@fredhutch.org.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Shepherd', 'Affiliation': 'University of Hawaii Cancer Center, Honolulu, HI 96813, USA. johnshep@hawaii.edu.'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Le Marchand', 'Affiliation': 'University of Hawaii Cancer Center, Honolulu, HI 96813, USA. Loic@cc.hawaii.edu.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Boushey', 'Affiliation': 'University of Hawaii Cancer Center, Honolulu, HI 96813, USA. CJBoushey@cc.hawaii.edu.'}]",Nutrients,['10.3390/nu11061386']
295,31422103,Pilot Study to Improve Goals of Care Conversations Among Hospitalists.,"CONTEXT


Many hospitalized patients receive care that is not concordant with their goals. Teaching communication skills that better align goals and treatment can improve the care that patients receive.
OBJECTIVE


To develop and test an innovative approach that encourages hospitalists to engage in goals of care (GOC) conversations with their patients.
METHODS


We recruited 14 hospitalists and randomized half to receive electronic health record alerts for patients who might benefit most from a goals-of-care conversation, as well as communication coaching. The coaching required an initial meeting, then audio recording of two GOC conversations and feedback from the coach. Outcomes were the presence of GOC conversations (primary), the quality of the GOC conversations, physician perceptions of the intervention, and hospital metrics (e.g., 30-day readmissions, referrals to palliative care).
RESULTS


We did not increase the frequency of GOC conversations but did improve the quality of the conversations. Patients of physicians who received the intervention had fewer 30-day readmission rates and were less likely to die 90 days after admission than patients of physicians in the control arm. Patients of intervention physicians also had fewer palliative care consults than patients of control physicians.
CONCLUSIONS


Teaching hospitalists to have GOC conversations translated into better skills and outcomes for patients. This pilot study shows promise and should be tested in a larger trial.",2019,Patients of physicians who received the intervention had fewer 30-day readmission rates and were less likely to die 90 days after admission than patients of physicians in the control arm.,['care conversations among hospitalists'],"['electronic health record alerts for patients who might benefit most from a goals of care conversation, as well as communication coaching']","['30-day readmission rates', 'frequency of goals of care conversations', 'presence of goals of care conversations (primary), the quality of the goals of care conversations, physician perceptions of the intervention, and hospital metrics (e.g., 30-day readmissions, referrals to palliative care', 'quality of the conversations']","[{'cui': 'C0600620', 'cui_str': 'Hospitalists'}]","[{'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]",,0.055919,Patients of physicians who received the intervention had fewer 30-day readmission rates and were less likely to die 90 days after admission than patients of physicians in the control arm.,"[{'ForeName': 'Kathryn I', 'Initials': 'KI', 'LastName': 'Pollak', 'Affiliation': 'Cancer Control and Populations Sciences, Duke Cancer Institute, Durham, North Carolina, USA; Department of Population Health Sciences, Duke School of Medicine, Durham, North Carolina, USA. Electronic address: kathryn.pollak@duke.edu.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Cancer Control and Populations Sciences, Duke Cancer Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Beliveau', 'Affiliation': 'Department of Medicine, Duke School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Griffith', 'Affiliation': 'Department of Medicine, Duke School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Kennedy', 'Affiliation': 'Cancer Control and Populations Sciences, Duke Cancer Institute, Durham, North Carolina, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Casarett', 'Affiliation': 'Cancer Control and Populations Sciences, Duke Cancer Institute, Durham, North Carolina, USA; Department of Medicine, Duke School of Medicine, Durham, North Carolina, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.06.007']
296,32242215,Effects of Psychosocial Interventions and Caregiving Stress on Cardiovascular Biomarkers in Family Dementia Caregivers: The UCSD Pleasant Events Program (PEP) Randomized Controlled Trial.,"BACKGROUND


This study examined whether biological mechanisms linking dementia caregiving with an increased risk of coronary heart disease can be modified by psychosocial interventions and which caregivers might benefit the most from an intervention.
METHODS


Spousal dementia caregivers were randomized to 12-week treatment with either a behavioral activation intervention (ie, Pleasant Events Program [PEP]; n = 60), or an active control Information and Support (IS; n = 63) condition. Indicators of caregiving stress were assessed pretreatment and circulating cardiovascular biomarkers were measured pre- and posttreatment.
RESULTS


There were no significant changes in biomarker levels from pre- to posttreatment both by treatment condition and across all caregivers. Regardless of the treatment condition, exploratory regression analysis revealed that caregivers were more likely to show significant decreases in C-reactive protein (CRP) and D-dimer when their spouse had severe functional impairment; in interleukin (IL)-6 and CRP when they had greater distress due to care recipient's problem behaviors; in tumor necrosis factor (TNF)-α when they had higher levels of negative affect; and in IL-6, CRP, TNF-α, and D-dimer when they had higher personal mastery. Within the PEP group, caregivers with higher negative affect and those with higher positive affect were more likely to show a reduction in von Willebrand factor and D-dimer, respectively. Within the IS group, caregivers whose spouse had severe functional impairment were more likely to show a decrease in IL-6.
CONCLUSIONS


Unlike the average caregiver, caregivers high in burden/distress and resources might benefit from psychosocial interventions to improve cardiovascular risk, although these observations need confirmation.",2020,There were no significant changes in biomarker levels from pre- to post-treatment both by treatment condition and across all caregivers.,"['Spousal dementia caregivers', 'family dementia caregivers']","['behavioral activation intervention (i.e., Pleasant Events Program PEP; n=60), or an active control Information and Support (IS; n=63) condition', 'psychosocial interventions and caregiving stress']","['biomarker levels', 'cardiovascular biomarkers', 'severe functional impairment', 'C-reactive protein (CRP) and D-dimer', 'IL-6, CRP, TNF-α and D-dimer', 'circulating cardiovascular biomarkers']","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0031642', 'cui_str': 'Phosphoenolpyruvate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}]",,0.0579614,There were no significant changes in biomarker levels from pre- to post-treatment both by treatment condition and across all caregivers.,"[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'von Känel', 'Affiliation': 'Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Mills', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Dimsdale', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Ziegler', 'Affiliation': 'Department of Medicine, University of California San Diego, La Jolla.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Allison', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, La Jolla.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Patterson', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Ancoli-Israel', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Pruitt', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, La Jolla.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Grant', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla.'}, {'ForeName': 'Brent T', 'Initials': 'BT', 'LastName': 'Mausbach', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa079']
297,32223762,Using motivational interviewing to reduce parental risk related behaviors for early childhood caries: a pilot study.,"BACKGROUND


Decades of epidemiological studies have documented high rates of early childhood caries (ECC) among American Indian and Alaska Native (AIAN) children. The aim of this pilot study was to investigate if a motivational interviewing (MI) intervention improved oral self-care behaviors of AIAN caregivers of infants, and determine if the MI intervention promoted positive changes in caregivers' ECC risk-related behaviors.
METHODS


Caregivers of infants presenting for well- child visits in a medical clinic were randomized to treatment and control groups. At the first visit, a caries risk test (CRT) for cariogenic bacteria was completed for both groups. The Parental Care of Child's Teeth (PCCT) was administered at the second visit and used to assess ECC risk-related behaviors. Over the course of four well-child visits, caregivers in the treatment group participated in a MI discussion focusing on behavior changes and desired outcomes for their personal oral health and their child's. The duration of the intervention was 1 year. The control group was given oral health information traditionally provided at well-child visits. At the fourth well-child visit, the CRT and PCCT questionnaire were administered again.
RESULTS


The mean bacterial load for mutans streptococcus (MS) was similar at both visits. A slight reduction in the mean bacterial levels of lactobacilli was observed in both the test and control groups after the last visit, although not at a level of statistical significance. The treatment group showed minimal improvement in child feeding practices and nighttime bottle habits.
CONCLUSIONS


Motivational Interviewing had little effect on oral self-care behaviors as measured by bacterial load, nor did MI reduce parental risk related behavior for early childhood caries.
TRIAL REGISTRATION


Clinicaltrials.gov# NCT04286256. Retrospectively registered, February 26, 2020.",2020,"A slight reduction in the mean bacterial levels of lactobacilli was observed in both the test and control groups after the last visit, although not at a level of statistical significance.","['Caregivers of infants presenting for well- child visits in a medical clinic', 'early childhood caries', 'American Indian and Alaska Native (AIAN) children', ""caregivers' ECC risk-related behaviors""]","['MI intervention', 'motivational interviewing (MI) intervention', 'motivational interviewing', 'Motivational Interviewing']","['mean bacterial load for mutans streptococcus (MS', 'child feeding practices and nighttime bottle habits', 'mean bacterial levels of lactobacilli', 'oral self-care behaviors']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1444717', 'cui_str': 'Well child visit'}, {'cui': 'C0338037', 'cui_str': ""Private physicians' group office (environment)""}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0002460', 'cui_str': 'American Indians'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319838', 'cui_str': 'Bottle'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}]",,0.0296306,"A slight reduction in the mean bacterial levels of lactobacilli was observed in both the test and control groups after the last visit, although not at a level of statistical significance.","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Blue', 'Affiliation': 'Division of Dental Hygiene, University of Minnesota, 515 Delaware Street SE, 9-372 Moos Tower, Minneapolis, MN, 55455, USA. bluex005@umn.edu.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Arnett', 'Affiliation': 'Division of Dental Hygiene, University of Minnesota, 420 Delaware St SE, MMC 729, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Hiwet', 'Initials': 'H', 'LastName': 'Ephrem', 'Affiliation': 'Division of Dental Hygiene, University of Minnesota, 515 Delaware Street SE, 9-372 Moos Tower, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Lunos', 'Affiliation': 'University of Minnesota, 717 Delaware Street SE, 140-27, Minneapolis, MN, 55414, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ruoqiong', 'Affiliation': 'Department of Diagnostic and Biological Sciences, University of Minnesota, 515 Delaware Street SE, 17-237 Moos Tower, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Division of Pediatric Dentistry, University of Minnesota, 515 Delaware Street SE, 6-150 Moos Tower, Minneapolis, MN, 55455, USA.'}]",BMC oral health,['10.1186/s12903-020-1052-6']
298,32239161,Role of Persistent and Worsening Sleep Disturbance in Depression Remission and Suicidal Ideation Among Older Primary Care Patients: The PROSPECT Study.,"STUDY OBJECTIVES


We analyzed data from a practice-based randomized controlled trial within 20 primary care practices located in greater New York City, Philadelphia, and Pittsburgh to determine whether persistent or worsening sleep disturbance plays a role in the outcomes of depression and suicidal ideation at 1 year in older adults with depression.
METHODS


The study sample consisted of 599 adults aged 60 years and older meeting criteria for major depression or clinically significant minor depression. Longitudinal analysis via growth curve mixture modeling was carried out to classify patients as having worsening, persistent, or improving sleep over 1 year.
RESULTS


At 1-year follow-up, compared with patients with improving sleep, those with worsening sleep were more likely to have a diagnosis of major depression (adjusted odds ratio (aOR) = 28.60, 95% confidence interval (CI) 12.15 to 67.34), a diagnosis of clinically significant minor depression (aOR = 11.88, 95% CI 5.67 to 24.89), and suicidal ideation (aOR = 1.10, 1.005 to 1.199), and were half as likely to achieve remission (aOR = 0.52, 95% CI 0.46 to 0.57). Patients with persistent sleep disturbance showed similar but attenuated results.
CONCLUSIONS


Older primary care patients with depression who exhibit worsening or persistent sleep disturbance were at increased risk for persistent depression and suicidal ideation 1 year later. The pattern of sleep disturbance over time may be an important signal for exploration by primary care physicians of depression and suicidal ideation among older adults with depression.",2020,"Patients with persistent sleep disturbance showed similar but attenuated results.
","['older adults with depression', '599 adults aged 60 years and older meeting criteria for major depression or clinically significant minor depression', 'Older Primary Care Patients', '20 primary care practices located in greater New York City, Philadelphia, and Pittsburgh to determine whether persistent or worsening sleep disturbance', 'Older primary care patients with depression who exhibit worsening or persistent sleep disturbance']",[],"['diagnosis of major depression', 'suicidal ideation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}]",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]",599.0,0.0662918,"Patients with persistent sleep disturbance showed similar but attenuated results.
","[{'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Gallo', 'Affiliation': 'Department of Mental Health, Johns Hopkins University Bloomberg School of Public Health.'}, {'ForeName': 'Seungyoung', 'Initials': 'S', 'LastName': 'Hwang', 'Affiliation': 'Department of Health Policy and Management Johns Hopkins University Bloomberg School of Public Health.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Truong', 'Affiliation': 'Department of Mental Health, Johns Hopkins University Bloomberg School of Public Health.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'Department of Psychiatry University of Pittsburgh School of Medicine Pittsburgh, Pennsylvania.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Spira', 'Affiliation': 'Department of Mental Health, Johns Hopkins University Bloomberg School of Public Health.'}]",Sleep,['10.1093/sleep/zsaa063']
299,32233959,Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in healthy toddlers: a Phase II randomized study.,"NEISSERIA MENINGITIDIS


can lead to invasive meningococcal disease to which young children are particularly vulnerable. We assessed the immunogenicity and safety of Sanofi Pasteur's investigational quadrivalent (serogroups A, C, Y, and W) meningococcal tetanus-toxoid conjugate vaccine, MenACYW-TT, as a single dose, in healthy meningococcal vaccine-naïve toddlers versus a licensed conjugate vaccine MCV4-TT (NCT03205358). In this Phase II study conducted in Finland, 188 toddlers aged 12-24 months were randomized 1:1 to MenACYW-TT or MCV4-TT. Serum bactericidal antibody assays using human complement (hSBA) and baby rabbit complement (rSBA) measured antibodies against each serogroup before and 30 days after vaccination. Participants were monitored for immediate adverse events (AEs) and post-vaccination AEs for 30 days. All analyses were descriptive. All 188 participants completed the study. The Day 30 hSBA seroresponses (hSBA titer <8 at baseline and post-vaccination titer ≥8, or ≥8 at baseline and ≥4-fold increase post-vaccination) were comparable between participants receiving MenACYW-TT (96.7-100%), and MCV4-TT (86.0-100.0%) for each serogroup. Most unsolicited AEs were of Grade 1 or Grade 2 intensity. There were no immediate hypersensitivity reactions, and no AEs or serious AEs leading to discontinuation from the study. In this exploratory study, MenACYW-TT vaccine was well tolerated and immunogenic. If confirmed in Phase III, a single dose of the MenACYW-TT vaccine may show promise as an alternative vaccine option for toddlers receiving meningococcal vaccination for the first time.",2020,"There were no immediate hypersensitivity reactions, and no AEs or serious AEs leading to discontinuation from the study.","['All 188 participants completed the study', 'healthy meningococcal vaccine-naïve toddlers', 'healthy toddlers', '188 toddlers aged 12-24\xa0months']","['quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT', 'MCV4-TT']","['tolerated and immunogenic', 'immediate hypersensitivity reactions', 'Immunogenicity and safety', 'immunogenicity and safety', 'immediate adverse events (AEs) and post-vaccination AEs']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0700144', 'cui_str': 'Meningococcus vaccine'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}]","[{'cui': 'C0020523', 'cui_str': 'IgE-mediated allergic disorder'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",188.0,0.211319,"There were no immediate hypersensitivity reactions, and no AEs or serious AEs leading to discontinuation from the study.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Vesikari', 'Affiliation': 'Vaccine Research Center, University of Tampere , Tampere, Finland.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Borrow', 'Affiliation': 'Vaccine Evaluation Unit, Public Health England , Manchester, UK.'}, {'ForeName': 'Aino', 'Initials': 'A', 'LastName': 'Forsten', 'Affiliation': 'Vaccine Research Center, University of Tampere , Tampere, Finland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Findlow', 'Affiliation': 'Vaccine Evaluation Unit, Public Health England , Manchester, UK.'}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Dhingra', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Jordanov', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1733869']
300,30587408,Randomized crossover trial of silicone hydrogel contact lenses.,"PURPOSE


The aim of the current study is to assess, using new technologies, the interaction of four monthly silicone hydrogel contact lenses on the ocular surface and the comfort over 15 days of use.
METHODS


Prospective cross-over, randomized and double-masked study including four materials (lotrafilcon-B, samfilcon-A , comfilcon-A and filcom-V3). Clinical examination was performed in the following order: tear meniscus height, first break-up of the tear film, the average time of all tear film breakup incidents, bulbar redness, limbal redness (Keratograph 5M ,Oculus, Germany); central corneal thickness (Pentacam, Oculus, Germany), thermography values (FLIR A325; FLIR Systems Inc., USA), and slit-lamp evaluations, including ocular surface staining. Finally, subjective comfort was obtained from Contact Lens Dry Eye Questionnaire-8.
RESULTS


The impact of contact lens wear on the ocular surface didn't show statistically significant changes over time except for corneal and conjunctival staining grades on day 15 compared to day 1 for the comfilcon A group (P = .003 and P = .01, respectively). Contact lens stability and impact on the ocular surface during contact lens wear didn't show statistically significant changes over time except in the case of the comfilcon A material with respect to the irritation item (P = .01).
CONCLUSIONS


These results suggest that the impact of monthly silicone hydrogel contact lens materials on the ocular surface after and during contact lens wear, contact lens stability over time, and subjective comfort did not reveal any significant changes over 15 days of use for any of the materials.",2019,Contact lens stability and impact on the ocular surface during contact lens wear didn't show statistically significant changes over time except in the case of the comfilcon,[],"['four materials (lotrafilcon-B, samfilcon-A , comfilcon-A and filcom-V3', 'silicone hydrogel contact lenses']","['subjective comfort', 'bulbar redness, limbal redness (Keratograph 5M ,Oculus, Germany); central corneal thickness (Pentacam, Oculus, Germany), thermography values (FLIR A325; FLIR Systems Inc., USA), and slit-lamp evaluations, including ocular surface staining']",[],"[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C2001571', 'cui_str': 'lotrafilcon B'}, {'cui': 'C2715682', 'cui_str': 'comfilcon A'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0443251', 'cui_str': 'Limbal (qualifier value)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0039810', 'cui_str': 'Temperature Mapping'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0183355', 'cui_str': ""Gullstrand's Slit Lamp""}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0487602', 'cui_str': 'Staining'}]",,0.0205383,Contact lens stability and impact on the ocular surface during contact lens wear didn't show statistically significant changes over time except in the case of the comfilcon,"[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'García-Montero', 'Affiliation': 'Department of Optometry and Vision, Faculty of Optics and Optometry, Complutense University of Madrid, Madrid, Spain. Electronic address: mgarc01@ucm.es.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rico-Del-Viejo', 'Affiliation': 'Department of Optometry and Vision, Faculty of Optics and Optometry, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Llorens-Quintana', 'Affiliation': 'Department of Biomedical Engineering, Faculty of Fundamental Problems of Technology, Wroclaw University of Science and Technology, Wroclaw, Poland.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Lorente-Velázquez', 'Affiliation': 'Department of Optometry and Vision, Faculty of Optics and Optometry, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Hernández-Verdejo', 'Affiliation': 'Department of Optometry and Vision, Faculty of Optics and Optometry, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Madrid-Costa', 'Affiliation': 'Department of Optometry and Vision, Faculty of Optics and Optometry, Complutense University of Madrid, Madrid, Spain.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2018.12.006']
301,31061511,The effects of chiropractic spinal manipulation on central processing of tonic pain - a pilot study using standardized low-resolution brain electromagnetic tomography (sLORETA).,"The objectives of the study were to investigate changes in pain perception and neural activity during tonic pain due to altered sensory input from the spine following chiropractic spinal adjustments. Fifteen participants with subclinical pain (recurrent spinal dysfunction such as mild pain, ache or stiffness but with no pain on the day of the experiment) participated in this randomized cross-over study involving a chiropractic spinal adjustment and a sham session, separated by 4.0 ± 4.2 days. Before and after each intervention, 61-channel electroencephalography (EEG) was recorded at rest and during 80 seconds of tonic pain evoked by the cold-pressor test (left hand immersed in 2 °C water). Participants rated the pain and unpleasantness to the cold-pressor test on two separate numerical rating scales. To study brain sources, sLORETA was performed on four EEG frequency bands: delta (1-4 Hz), theta (4-8 Hz), alpha (8-12 Hz) and beta (12-32 Hz). The pain scores decreased by 9% after the sham intervention (p < 0.05), whereas the unpleasantness scores decreased by 7% after both interventions (p < 0.05). sLORETA showed decreased brain activity following tonic pain in all frequency bands after the sham intervention, whereas no change in activity was seen after the chiropractic spinal adjustment session. This study showed habituation to pain following the sham intervention, with no habituation occurring following the chiropractic intervention. This suggests that the chiropractic spinal adjustments may alter central processing of pain and unpleasantness.",2019,"The pain scores decreased by 9% after the sham intervention (p < 0.05), whereas the unpleasantness scores decreased by 7% after both interventions (p < 0.05).","['Fifteen participants with subclinical pain (recurrent spinal dysfunction such as mild pain, ache or stiffness but with no pain on the day of the experiment) participated']","['chiropractic spinal manipulation', 'standardized low-resolution brain electromagnetic tomography (sLORETA']","['brain activity following tonic pain', 'activity', 'pain and unpleasantness', 'central processing of pain and unpleasantness', 'pain perception and neural activity', 'pain scores', '61-channel electroencephalography (EEG', 'unpleasantness scores']","[{'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0278138', 'cui_str': 'Mild pain (finding)'}, {'cui': 'C0234238', 'cui_str': 'Ache'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0086586', 'cui_str': 'Manipulation, Spinal'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",15.0,0.0889263,"The pain scores decreased by 9% after the sham intervention (p < 0.05), whereas the unpleasantness scores decreased by 7% after both interventions (p < 0.05).","[{'ForeName': 'Muhammad Samran', 'Initials': 'MS', 'LastName': 'Navid', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Lelic', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Imran Khan', 'Initials': 'IK', 'LastName': 'Niazi', 'Affiliation': 'Centre for Chiropractic Research, New Zealand College of Chiropractic, Auckland, New Zealand. imran.niazi@nzchiro.co.nz.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Holt', 'Affiliation': 'Centre for Chiropractic Research, New Zealand College of Chiropractic, Auckland, New Zealand.'}, {'ForeName': 'Esben Bolvig', 'Initials': 'EB', 'LastName': 'Mark', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Asbjørn Mohr', 'Initials': 'AM', 'LastName': 'Drewes', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Haavik', 'Affiliation': 'Centre for Chiropractic Research, New Zealand College of Chiropractic, Auckland, New Zealand.'}]",Scientific reports,['10.1038/s41598-019-42984-3']
302,32219359,Effect of Apabetalone Added to Standard Therapy on Major Adverse Cardiovascular Events in Patients With Recent Acute Coronary Syndrome and Type 2 Diabetes: A Randomized Clinical Trial.,"Importance


Bromodomain and extraterminal proteins are epigenetic regulators of gene transcription. Apabetalone is a selective bromodomain and extraterminal protein inhibitor targeting bromodomain 2 and is hypothesized to have potentially favorable effects on pathways related to atherothrombosis. Pooled phase 2 data suggest favorable effects on clinical outcomes.
Objective


To test whether apabetalone significantly reduces major adverse cardiovascular events.
Design, Setting, and Participants


A randomized, double-blind, placebo-controlled trial, conducted at 190 sites in 13 countries. Patients with an acute coronary syndrome in the preceding 7 to 90 days, type 2 diabetes, and low high-density lipoprotein cholesterol levels were eligible for enrollment, which started November 11, 2015, and ended July 4, 2018, with end of follow-up on July 3, 2019.
Interventions


Patients were randomized (1:1) to receive apabetalone, 100 mg orally twice daily (n = 1215), or matching placebo (n = 1210) in addition to standard care.
Main Outcomes and Measures


The primary outcome was a composite of time to the first occurrence of cardiovascular death, nonfatal myocardial infarction, or stroke.
Results


Among 2425 patients who were randomized (mean age, 62 years; 618 women [25.6%]), 2320 (95.7%) had full ascertainment of the primary outcome. During a median follow-up of 26.5 months, 274 primary end points occurred: 125 (10.3%) in apabetalone-treated patients and 149 (12.4%) in placebo-treated patients (hazard ratio, 0.82 [95% CI, 0.65-1.04]; P = .11). More patients allocated to apabetalone than placebo discontinued study drug (114 [9.4%] vs 69 [5.7%]) for reasons including elevations of liver enzyme levels (35 [2.9%] vs 11 [0.9%]).
Conclusions and Relevance


Among patients with recent acute coronary syndrome, type 2 diabetes, and low high-density lipoprotein cholesterol levels, the selective bromodomain and extraterminal protein inhibitor apabetalone added to standard therapy did not significantly reduce the risk of major adverse cardiovascular events.
Trial Registration


ClinicalTrials.gov Identifier: NCT02586155.",2020,"More patients allocated to apabetalone than placebo discontinued study drug (114 [9.4%] vs 69 [5.7%]) for reasons including elevations of liver enzyme levels (35 [2.9%] vs 11 [0.9%]).
","['2425 patients who were randomized (mean age, 62 years; 618 women [25.6%]), 2320 (95.7%) had full ascertainment of the primary outcome', 'controlled trial, conducted at 190 sites in 13 countries', 'Patients', 'patients with recent acute coronary syndrome, type 2 diabetes', 'Patients with an acute coronary syndrome in the preceding 7 to 90 days, type 2 diabetes, and low high-density lipoprotein cholesterol levels were eligible for enrollment, which started November 11, 2015, and ended July 4, 2018, with end of follow-up on July 3, 2019']","['apabetalone, 100 mg orally twice daily (n\u2009=\u20091215), or matching placebo', 'Apabetalone Added to Standard Therapy', 'placebo']","['composite of time to the first occurrence of cardiovascular death, nonfatal myocardial infarction, or stroke', 'elevations of liver enzyme levels', 'Major Adverse Cardiovascular Events', 'major adverse cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1287351', 'cui_str': 'Finding of liver enzyme levels (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",2425.0,0.633565,"More patients allocated to apabetalone than placebo discontinued study drug (114 [9.4%] vs 69 [5.7%]) for reasons including elevations of liver enzyme levels (35 [2.9%] vs 11 [0.9%]).
","[{'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Imperial College London, United Kingdom.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Buhr', 'Affiliation': 'Statistical Data Analysis Center, University of Wisconsin-Madison.'}, {'ForeName': 'Henry N', 'Initials': 'HN', 'LastName': 'Ginsberg', 'Affiliation': 'Irving Institute for Clinical and Translational Research, Columbia University, New York, New York.'}, {'ForeName': 'Jan O', 'Initials': 'JO', 'LastName': 'Johansson', 'Affiliation': 'Resverlogix Corporation, Calgary, Alberta, Canada.'}, {'ForeName': 'Kamyar', 'Initials': 'K', 'LastName': 'Kalantar-Zadeh', 'Affiliation': 'Division of Nephrology and Hypertension, University of California-Irvine.'}, {'ForeName': 'Ewelina', 'Initials': 'E', 'LastName': 'Kulikowski', 'Affiliation': 'Resverlogix Corporation, Calgary, Alberta, Canada.'}, {'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Toth', 'Affiliation': 'CGH Medical Center, Sterling, Illinois, and Cicarrone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wong', 'Affiliation': 'Resverlogix Corporation, Calgary, Alberta, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sweeney', 'Affiliation': 'Resverlogix Corporation, Calgary, Alberta, Canada.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.3308']
303,31988481,Effectiveness and cost-effectiveness of The Daily Mile on childhood weight outcomes and wellbeing: a cluster randomised controlled trial.,"BACKGROUND


The Daily Mile is designed to increase physical activity levels with children running or walking around school grounds for 15-min daily. It has been adopted by schools worldwide and endorsed as a solution to tackle obesity, despite no robust evidence of its benefits. We conducted a cluster randomised controlled trial to determine its clinical and cost-effectiveness.
METHODS


Forty schools were randomly assigned (1:1) to either the Daily Mile intervention or control group in which only the usual school health and wellbeing activities were implemented. The primary outcome was BMI z-score (BMIz) at 12 months follow-up from baseline, with planned subgroup analysis to examine differential effects. Primary economic analysis outcome was incremental cost per Quality-Adjusted-Life-Year (QALY) gained.
RESULTS


Using a constrained randomisation approach, balanced on school size, baseline BMIz and proportion of pupils eligible for free school meals, 20 schools were allocated to intervention (n = 1,153 participants) and 20 to control (n = 1,127); 3 schools withdrew (2 intervention, 1 control). At 12 months, BMIz data were available for 18 intervention schools (n = 850) and 19 control schools (n = 820 participants). Using intention-to-treat analysis the adjusted mean difference (MD) in BMIz (intervention - control) was -0.036 (95% CI: -0.085 to 0.013, p = 0.146). Pre-specified subgroup analysis showed a significant interaction with sex (p = 0.001) suggesting a moderate size benefit of The Daily Mile in girls (MD -0.097, 95% CI -0.156 to -0.037). This was consistent with the exploratory economic results that showed The Daily Mile to be highly cost-effective in girls (£2,492 per QALY), but not in boys, and overall to have a 76% chance of cost-effectiveness for the whole sample, at the commonly applied UK threshold of £20,000 per QALY.
CONCLUSIONS


Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.",2020,"Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.","['pupils eligible for free school meals, 20 schools', 'Forty schools']","['Daily Mile', 'Daily Mile intervention or control group in which only the usual school health and wellbeing activities were implemented']","['Effectiveness and cost-effectiveness', 'physical activity levels', 'childhood weight outcomes and wellbeing', 'BMI z-score (BMIz', 'BMIz', 'incremental cost per Quality-Adjusted-Life-Year (QALY) gained']","[{'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0331865', 'cui_str': 'Mile (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",40.0,0.246083,"Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Breheny', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Passmore', 'Affiliation': 'Services for Education, Birmingham, B7 4AX, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK. p.adab@bham.ac.uk.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Lancashire', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Frew', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK. e.frew@bham.ac.uk.'}]",International journal of obesity (2005),['10.1038/s41366-019-0511-0']
304,30866027,Effect of Treatment of Mild Gestational Diabetes on Long-Term Maternal Outcomes.,"OBJECTIVE


The main purpose of this article is to evaluate whether identification and treatment of women with mild gestational diabetes mellitus (GDM) during pregnancy affects subsequent maternal body mass index (BMI), anthropometry, metabolic syndrome, and risk of diabetes.
STUDY DESIGN


This is a follow-up study of women who participated in a randomized controlled treatment trial for mild GDM. Women were enrolled between 5 and 10 years after their index pregnancy. Participants underwent blood pressure, height, weight, and anthropometric measurements by trained nursing personnel using a standardized approach. A nurse-assisted questionnaire regarding screening and treatment of diabetes or hypercholesterolemia, diet, and physical activity was completed. Laboratory evaluation included fasting serum glucose, fasting insulin, oral glucose tolerance test, and a lipid panel. Subsequent diabetes, metabolic syndrome, obesity, and adiposity in those diagnosed with mild GDM and randomized to nutritional counseling and medical therapy (treated) were compared with those who underwent routine pregnancy management (untreated). Multivariable analyses were performed adjusting for race/ethnicity and years between randomization and follow-up visit.
RESULTS


Four-hundred fifty-seven women with mild GDM during the index pregnancy were included in this analysis (243 treated; 214 untreated) and evaluated at a median 7 years after their index pregnancy. Baseline and follow-up characteristics were similar between treatment groups. Frequency of diabetes (9.2 vs. 8.5%,  p  =0.80), metabolic syndrome (32.2 vs. 34.3%,  p  =0.63), as well as adjusted mean values of homeostasis model assessment for insulin resistance (2.5 vs. 2.3,  p  =0.11) and BMI (29.4 vs. 29.1 kg/m 2 ,  p  =0.67) were also not different.
CONCLUSION


Identification and treatment of women with mild GDM during pregnancy had no discernible impact on subsequent diabetes, metabolic syndrome, or obesity 7 years after delivery.",2020,"Frequency of diabetes (9.2 vs. 8.5%,  p  =0.80), metabolic syndrome (32.2 vs. 34.3%,  p  =0.63), as well as adjusted mean values of homeostasis model assessment for insulin resistance (2.5 vs. 2.3,  p  =0.11) and BMI (29.4 vs. 29.1 kg/m 2 ,  p  =0.67) were also not different.
","['women with mild gestational diabetes mellitus (GDM', 'Four-hundred fifty-seven women with mild GDM during the index pregnancy were included in this analysis (243 treated; 214 untreated) and evaluated at a median 7 years after their index pregnancy', 'Women were enrolled between 5 and 10 years after their index pregnancy', 'women who participated in a randomized controlled treatment trial for mild GDM']",['nutritional counseling and medical therapy (treated'],"['metabolic syndrome', 'homeostasis model assessment for insulin resistance', 'BMI', 'Frequency of diabetes', 'Subsequent diabetes, metabolic syndrome, obesity, and adiposity', 'maternal body mass index (BMI), anthropometry, metabolic syndrome, and risk of diabetes', 'fasting serum glucose, fasting insulin, oral glucose tolerance test, and a lipid panel']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0200382', 'cui_str': 'Lipid panel (procedure)'}]",457.0,0.0436331,"Frequency of diabetes (9.2 vs. 8.5%,  p  =0.80), metabolic syndrome (32.2 vs. 34.3%,  p  =0.63), as well as adjusted mean values of homeostasis model assessment for insulin resistance (2.5 vs. 2.3,  p  =0.11) and BMI (29.4 vs. 29.1 kg/m 2 ,  p  =0.67) were also not different.
","[{'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Madeline Murguia', 'Initials': 'MM', 'LastName': 'Rice', 'Affiliation': 'George Washington University Biostatistics Center, Washington, District of Columbia.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Landon', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Varner', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah.'}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, New York, New York.'}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': 'Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Biggio', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Peaceman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Blackwell', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas.""}, {'ForeName': 'J Peter', 'Initials': 'JP', 'LastName': 'Van Dorsten', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of perinatology,['10.1055/s-0039-1681058']
305,31442484,Efficacy of a Decision Aid Consisting of a Video and Booklet on Advance Care Planning for Advanced Cancer Patients: Randomized Controlled Trial.,"CONTEXT


Few randomized controlled trials of advance care planning (ACP) with a decision aid (DA) show an effect on patient preferences for end-of-life (EOL) care over time, especially in racial/ethnic settings outside the U.S.
OBJECTIVES


The objective of this study was to examine the effect of a decision aid consisting of a video and an ACP booklet for EOL care preferences among patients with advanced cancer.
METHODS


Using a computer-generated sequence, we randomly assigned (1:1) patients with advanced cancer to a group that received a video and workbook that both discussed either ACP (intervention group) or cancer pain control (control group). At baseline, immediately after intervention, and at 7 weeks, we evaluated the subjects' preferences. The primary outcome was preference for EOL care (active treatment, life-prolonging treatment, or hospice care) on the assumption of a fatal disease diagnosis and the expectation of death 1) within 1 year, 2) within several months, and 3) within a few weeks. We used Bonferroni correction methods for multiple comparisons with an adjusted P level of 0.005.
RESULTS


From August 2017 to February 2018, we screened 287 eligible patients, of whom 204 were enrolled to the intervention (104 patients) or the control (100 patients). At postintervention, the intervention group showed a significant increase in preference for active treatment, life-prolonging treatment, and hospice care on the assumption of a fatal disease diagnosis and the expectation of death within 1 year (P < 0.005). Assuming a life expectancy of several months, the change in preferences was significant for active treatment and hospice care (P < 0.005) but not for life-prolonging treatment. The intervention group showed a significant increase in preference for active treatment, life-prolonging treatment, and hospice care on the assumption of a fatal disease diagnosis and the expectation of death within a few weeks (P < 0.005). From baseline to 7 weeks, the decrease in preference in the intervention group was not significant for active treatment, life-prolonging treatment, and hospice care in the intervention group in the subset expecting to die within 1 year, compared with the control group. Assuming a life expectancy of several months and a few weeks, the change in preferences was not significant for active treatment and for life-prolonging treatment but was significantly greater for hospice care in the intervention group (P < 0.005).
CONCLUSION


ACP interventions that included a video and an accompanying book improved preferences for EOL care.",2019,"At post-intervention, the intervention group showed a significant increase in preference for active treatment, life-prolonging treatment, and hospice care on the assumption of a fatal disease diagnosis and the expectation of death within 1 year (p<0.005).","['patients with advanced cancer', 'From August 2017 to February 2018, we screened 287 eligible patients, of whom 204 were enrolled to the intervention (104 patients) or the control (100 patients', 'advanced cancer patients']","['decision aid consisting of a video and an advance care planning (ACP) booklet', 'decision aid consisting of a video and booklet', 'video and workbook that both discussed either ACP (intervention group) or cancer pain control (control group']","['preference for active treatment, life-prolonging treatment, and hospice care on the assumption of a fatal disease diagnosis and the expectation of death', 'preference for EOL care (active treatment, life-prolonging treatment, or hospice care) on the assumption of a fatal disease diagnosis and the expectation of death 1', 'hospice care']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0085555', 'cui_str': 'Hospice Care'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",204.0,0.0666446,"At post-intervention, the intervention group showed a significant increase in preference for active treatment, life-prolonging treatment, and hospice care on the assumption of a fatal disease diagnosis and the expectation of death within 1 year (p<0.005).","[{'ForeName': 'Young Ho', 'Initials': 'YH', 'LastName': 'Yun', 'Affiliation': 'Department of Biomedical Science, Seoul National University College of Medicine, Seoul, South Korea; Department of Family Medicine, Seoul National University College of Medicine, Seoul, South Korea; Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea. Electronic address: lawyun08@gmail.com.'}, {'ForeName': 'EunKyo', 'Initials': 'E', 'LastName': 'Kang', 'Affiliation': 'Department of Family Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sohee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Biostatics, Graduate School of Public Health, Yonsei University, Seoul, South Korea.'}, {'ForeName': 'Su-Jin', 'Initials': 'SJ', 'LastName': 'Koh', 'Affiliation': 'Department of Hematology and Oncology, Ulsan University Hospital, Ulsan University College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Ho-Suk', 'Initials': 'HS', 'LastName': 'Oh', 'Affiliation': 'Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, South Korea.'}, {'ForeName': 'Bhumsuk', 'Initials': 'B', 'LastName': 'Keam', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Young Rok', 'Initials': 'YR', 'LastName': 'Do', 'Affiliation': 'Dongsan Medical Center, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Won Jin', 'Initials': 'WJ', 'LastName': 'Chang', 'Affiliation': 'Division of Hemato-Oncology, Department of Internal medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyun Sik', 'Initials': 'HS', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, G Sam Hospital, Gunpo, South Korea.'}, {'ForeName': 'Eun Mi', 'Initials': 'EM', 'LastName': 'Nam', 'Affiliation': 'Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hak Ro', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Department of Hematology and Oncology, Pohang Semyeng Christianity Hospital, Pohang, Kyeongbuk, South Korea.'}, {'ForeName': 'Jiyeon', 'Initials': 'J', 'LastName': 'Choo', 'Affiliation': 'Department of Biomedical Science, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Biomedical Science, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jin-Ah', 'Initials': 'JA', 'LastName': 'Sim', 'Affiliation': 'Department of Biomedical Science, Seoul National University College of Medicine, Seoul, South Korea; Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.07.032']
306,32167605,Equivalent efficacies of reverse hybrid and concomitant therapies in first-line treatment of Helicobacter pylori infection.,"BACKGROUND AND AIM


Concomitant therapy is a recommended first-line treatment for Helicobacter pylori infection in most national or international consensuses. Reverse hybrid therapy is a modified 14-day concomitant therapy without clarithromycin and metronidazole in the final 7 days. This study aims to test whether 14-day reverse hybrid therapy is non-inferior to 14-day concomitant therapy in the first-line treatment of H. pylori infection.
METHODS


Helicobacter pylori-infected adult patients were randomly assigned to receive either reverse hybrid therapy (dexlansoprazole 60 mg o.d. plus amoxicillin 1 g b.d. for 14 days, and clarithromycin 500 mg plus metronidazole 500 mg b.d. for initial 7 days) or concomitant therapy (dexlansoprazole 60 mg once o.d. plus amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg b.d. for 14 days). H. pylori status was assessed 6 weeks after the end of treatment.
RESULTS


Helicobacter pylori-infected participants (n = 248) were randomized to receive either 14-day reverse hybrid therapy (n = 124) or 14-day concomitant therapy (n = 124). Intention-to-treat analysis demonstrated that the two therapies had comparable eradication rate (95.2% vs 93.5%; 95% confidence interval, -4.0% to 7.4%; P = 0.582). However, reverse hybrid therapy had a much lower frequency of adverse events than concomitant therapy (20.2% vs 38.7%, P = 0.001). The two therapies exhibited comparable drug adherence (93.5% vs 87.9%, P = 0.125).
CONCLUSIONS


Fourteen-day reverse hybrid therapy and 14-day concomitant therapy are equivalent in efficacy for the first-line treatment of H. pylori infection. However, reverse hybrid therapy has fewer adverse events compared with concomitant therapy.",2020,"The two therapies exhibited comparable drug adherence (93.5% vs 87.9%, P = 0.125).
","['H. pylori-infected participants (n = 248', 'H. pylori-infected adult patients']","['reverse hybrid therapy (dexlansoprazole 60 mg o.d. plus amoxicillin', 'clarithromycin 500 mg plus metronidazole', 'clarithromycin and metronidazole', '14-day concomitant therapy', '14-day reverse hybrid therapy', 'concomitant therapy (dexlansoprazole 60 mg once o.d. plus amoxicillin 1 g, clarithromycin 500 mg and metronidazole']","['adverse events', 'H. pylori status', 'frequency of adverse events', 'eradication rate', 'drug adherence']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2608717', 'cui_str': 'dexlansoprazole 60 MG'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]",248.0,0.0285836,"The two therapies exhibited comparable drug adherence (93.5% vs 87.9%, P = 0.125).
","[{'ForeName': 'Ping-I', 'Initials': 'PI', 'LastName': 'Hsu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, An Nan Hospital, China Medical University, Tainan, Taiwan.'}, {'ForeName': 'Feng-Woei', 'Initials': 'FW', 'LastName': 'Tsay', 'Affiliation': 'Department of Internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan.'}, {'ForeName': 'John Y', 'Initials': 'JY', 'LastName': 'Kao', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, Michigan Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Nan-Jing', 'Initials': 'NJ', 'LastName': 'Peng', 'Affiliation': 'Department of Nuclear Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan.'}, {'ForeName': 'Kuo-Wang', 'Initials': 'KW', 'LastName': 'Tsai', 'Affiliation': 'Department of Medical Education and Research, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Tzung-Jiun', 'Initials': 'TJ', 'LastName': 'Tsai', 'Affiliation': 'Department of Internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan.'}, {'ForeName': 'Chao-Hung', 'Initials': 'CH', 'LastName': 'Kuo', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Municipal Siaogang\xa0Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Sung-Shuo', 'Initials': 'SS', 'LastName': 'Kao', 'Affiliation': 'Department of Internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan.'}, {'ForeName': 'Huay-Min', 'Initials': 'HM', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan.'}, {'ForeName': 'Yan-Hua', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Department of Internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan.'}, {'ForeName': 'Chang-Bih', 'Initials': 'CB', 'LastName': 'Shie', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, An Nan Hospital, China Medical University, Tainan, Taiwan.'}, {'ForeName': 'Deng-Chyang', 'Initials': 'DC', 'LastName': 'Wu', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Municipal Siaogang Hospital, Kaohsiung, Taiwan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15034']
307,31061432,Randomized comparison between indocyanine green fluorescence plus  99m technetium and  99m technetium alone methods for sentinel lymph node biopsy in breast cancer.,"Use of both patent blue and a radioisotope to locate, and reduce the risk of sentinel lymph node (SLN) detection failure in breast cancer is recommended, but drawbacks commonly lead to using only a radioisotope. An alternative method would therefore be valuable. This randomized, controlled study in 99 patients compared SLN detection using  99m technetium (Tc) alone versus Tc combined with indocyanine green (ICG). The primary endpoint was the SLN identification rate. The primary outcome measure was the number of patients with <2 SLN detected. One SLN was detected in 44.0% of patients in the dual detection group and 40.8% in the  99m Tc alone group (RR = 1.08 (95% CI 0.68; 1.72), p = 0.84). A mean (±SD) of 2.14 ± 1.23 SLN were identified in the dual detection group vs. 1.77 ± 0.85 using Tc alone (p = 0.09). Eight-five (78.7%) SLN were both ICG+ and TC+, 15 (13.9%) ICG+ and Tc-, and 7 (6.5%) ICG- and Tc+. SLN detected were ICG-positive in 92.6% of patients and  99m Tc-positive in 85.2% with. No adverse event related to ICG injection was recorded. Dual detection of SLN using ICG and radioisotope is reliable and sensitive but was not superior to isotope alone in successfully locating SLN in our pilot randomized trial.",2019,Dual detection of SLN using ICG and radioisotope is reliable and sensitive but was not superior to isotope alone in successfully locating SLN in our pilot randomized trial.,"['99 patients compared', 'sentinel lymph node biopsy in breast cancer']","['indocyanine green fluorescence plus  99m technetium and  99m technetium alone methods', 'SLN detection using  99m technetium (Tc) alone versus Tc combined with indocyanine green (ICG', 'ICG and radioisotope']","['SLN identification rate', 'ICG-positive', 'number of patients with <2 SLN']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0796693', 'cui_str': 'Sentinel Lymph Node Biopsy'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0039411', 'cui_str': 'Technetium'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0034595', 'cui_str': 'Radionuclides'}]","[{'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",99.0,0.0594574,Dual detection of SLN using ICG and radioisotope is reliable and sensitive but was not superior to isotope alone in successfully locating SLN in our pilot randomized trial.,"[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Vermersch', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital, Saint-Etienne, F-42055, France.'}, {'ForeName': 'Tiphaine', 'Initials': 'T', 'LastName': 'Raia-Barjat', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital, Saint-Etienne, F-42055, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Chapelle', 'Affiliation': 'Clinical research, Innovation and Pharmacology unit, University Hospital, Saint-Etienne, F-42055, France.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Lima', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital, Saint-Etienne, F-42055, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Chauleur', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital, Saint-Etienne, F-42055, France. celine.chauleur@chu-st-etienne.fr.'}]",Scientific reports,['10.1038/s41598-019-43473-3']
308,31623894,"Effects of tranexamic acid on death, disability, vascular occlusive events and other morbidities in patients with acute traumatic brain injury (CRASH-3): a randomised, placebo-controlled trial.","BACKGROUND


Tranexamic acid reduces surgical bleeding and decreases mortality in patients with traumatic extracranial bleeding. Intracranial bleeding is common after traumatic brain injury (TBI) and can cause brain herniation and death. We aimed to assess the effects of tranexamic acid in patients with TBI.
METHODS


This randomised, placebo-controlled trial was done in 175 hospitals in 29 countries. Adults with TBI who were within 3 h of injury, had a Glasgow Coma Scale (GCS) score of 12 or lower or any intracranial bleeding on CT scan, and no major extracranial bleeding were eligible. The time window for eligibility was originally 8 h but in 2016 the protocol was changed to limit recruitment to patients within 3 h of injury. This change was made blind to the trial data, in response to external evidence suggesting that delayed treatment is unlikely to be effective. We randomly assigned (1:1) patients to receive tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or matching placebo. Patients were assigned by selecting a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was head injury-related death in hospital within 28 days of injury in patients treated within 3 h of injury. We prespecified a sensitivity analysis that excluded patients with a GCS score of 3 and those with bilateral unreactive pupils at baseline. All analyses were done by intention to treat. This trial was registered with ISRCTN (ISRCTN15088122), ClinicalTrials.gov (NCT01402882), EudraCT (2011-003669-14), and the Pan African Clinical Trial Registry (PACTR20121000441277).
RESULTS


Between July 20, 2012, and Jan 31, 2019, we randomly allocated 12 737 patients with TBI to receive tranexamic acid (6406 [50·3%] or placebo [6331 [49·7%], of whom 9202 (72·2%) patients were treated within 3 h of injury. Among patients treated within 3 h of injury, the risk of head injury-related death was 18·5% in the tranexamic acid group versus 19·8% in the placebo group (855 vs 892 events; risk ratio [RR] 0·94 [95% CI 0·86-1·02]). In the prespecified sensitivity analysis that excluded patients with a GCS score of 3 or bilateral unreactive pupils at baseline, the risk of head injury-related death was 12·5% in the tranexamic acid group versus 14·0% in the placebo group (485 vs 525 events; RR 0·89 [95% CI 0·80-1·00]). The risk of head injury-related death reduced with tranexamic acid in patients with mild-to-moderate head injury (RR 0·78 [95% CI 0·64-0·95]) but not in patients with severe head injury (0·99 [95% CI 0·91-1·07]; p value for heterogeneity 0·030). Early treatment was more effective than was later treatment in patients with mild and moderate head injury (p=0·005) but time to treatment had no obvious effect in patients with severe head injury (p=0·73). The risk of vascular occlusive events was similar in the tranexamic acid and placebo groups (RR 0·98 (0·74-1·28). The risk of seizures was also similar between groups (1·09 [95% CI 0·90-1·33]).
INTERPRETATION


Our results show that tranexamic acid is safe in patients with TBI and that treatment within 3 h of injury reduces head injury-related death. Patients should be treated as soon as possible after injury.
FUNDING


National Institute for Health Research Health Technology Assessment, JP Moulton Charitable Trust, Department of Health and Social Care, Department for International Development, Global Challenges Research Fund, Medical Research Council, and Wellcome Trust (Joint Global Health Trials scheme).
TRANSLATIONS


For the Arabic, Chinese, French, Hindi, Japanese, Spanish and Urdu translations of the abstract see Supplementary Material.",2019,Early treatment was more effective than was later treatment in patients with mild and moderate head injury (p=0·005) but time to treatment had no obvious effect in patients with severe head injury (p=0·73).,"['patients with traumatic extracranial bleeding', '175 hospitals in 29 countries', '737 patients with TBI to receive', 'Adults with TBI who were within 3 h of injury, had a Glasgow Coma Scale (GCS) score of 12 or lower or any intracranial bleeding on CT scan, and no major extracranial bleeding were eligible', 'patients with acute traumatic brain injury (CRASH-3', 'excluded patients with a GCS score of 3 and those with bilateral unreactive pupils at baseline', 'patients with TBI', 'Between July 20, 2012, and Jan 31, 2019']","['tranexamic acid', 'Tranexamic acid', 'placebo', 'tranexamic acid and placebo', 'tranexamic acid (loading dose', 'EudraCT']","['risk of seizures', 'risk of head injury-related death', 'time window for eligibility', 'risk of vascular occlusive events', 'Intracranial bleeding', 'death, disability, vascular occlusive events and other morbidities', 'head injury-related death in hospital within 28 days of injury']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0580586', 'cui_str': 'Extracranial (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0018674', 'cui_str': 'Head Trauma'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0557702', 'cui_str': 'Window (physical object)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0277608', 'cui_str': 'Death in hospital (event)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",8.0,0.76451,Early treatment was more effective than was later treatment in patients with mild and moderate head injury (p=0·005) but time to treatment had no obvious effect in patients with severe head injury (p=0·73).,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)32233-0']
309,31177482,Effect of Brief Cognitive Behavioral Counseling and Debriefing on the Prevention of Post-traumatic Stress Disorder in Traumatic Birth: A Randomized Clinical Trial.,"OBJECTIVE


Planning to promote the health of mothers in postpartum is important in all countries. This study aimed to determine the effectiveness of two counseling method on prevention of post-traumatic stress after childbirth.
METHODS


In this clinical trial, 193 of mothers who had experienced a traumatic birth were randomly assigned to three groups. Participants were assessed using IES_R questionnaire at 4-6 weeks and 3 months after delivery.
RESULTS


Debriefing and brief cognitive behavioral counseling (CBC) significantly improved the symptoms of postpartum traumatic stress disorder. After 3 months, CBC had a significant effect on the symptoms.
CONCLUSION


Screening of traumatic childbirth, implementation of supportive care, and early counseling prior to the initiation of post-traumatic stress are recommended.
TRIAL REGISTRATION NUMBER


IRCT2015072522396N2. http://en.search.irct.ir/view/24735 .",2019,"RESULTS


Debriefing and brief cognitive behavioral counseling (CBC) significantly improved the symptoms of postpartum traumatic stress disorder.","['193 of mothers who had experienced a traumatic birth', 'Post-traumatic Stress Disorder in Traumatic Birth']","['Debriefing and brief cognitive behavioral counseling (CBC', 'Brief Cognitive Behavioral Counseling and Debriefing']","['symptoms', 'symptoms of postpartum traumatic stress disorder', 'IES_R questionnaire']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling (procedure)'}, {'cui': 'C0009555', 'cui_str': 'Complete Blood Count'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0038441', 'cui_str': 'Stress Disorders, Traumatic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",193.0,0.132497,"RESULTS


Debriefing and brief cognitive behavioral counseling (CBC) significantly improved the symptoms of postpartum traumatic stress disorder.","[{'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Abdollahpour', 'Affiliation': 'Midwifery Counseling, Department of Midwifery, School of Nursing and Midwifery, Torbat Heydariyeh University of Medical Sciences, Torbat Heydariyeh, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Khosravi', 'Affiliation': 'Center for Health Related Social and Behavioral Sciences Research, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Motaghi', 'Affiliation': 'School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Keramat', 'Affiliation': 'Center for Health Related Social and Behavioral Sciences Research, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Seyed Abbas', 'Initials': 'SA', 'LastName': 'Mousavi', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center, Addiction Institute, Department of Psychiatry, Mazandaran University of Medical Sciences, Sari, Iran. mmm89099@gmail.com.'}]",Community mental health journal,['10.1007/s10597-019-00424-6']
310,31539605,Brief English and Spanish Survey Detects Change in Response to Advance Care Planning Interventions.,"CONTEXT


The validated 82-item Advance Care Planning (ACP) Engagement Survey measures a broad range of ACP behaviors but is long.
OBJECTIVES


Determine whether shorter survey versions (55-item, 34-item, 15-item, 9-item, and 4-item versions) can detect similar change in response to two well-validated ACP interventions and provide practical effect size information.
METHODS


We assessed ACP engagement for 986 English- and Spanish-speaking adults in a randomized trial of PREPARE vs. an advance directive-only study arms. The survey was administered at baseline, one week, three months, six months, and 12 months. We calculated mean change scores from baseline to follow-up time points by study arm, intraclass correlation coefficients of change scores between the 82-item survey with shorter versions, and within-group and between-group effect sizes of the mean change scores.
RESULTS


Shorter survey versions were able to detect within-group and between-group changes at all time points. Within-group intraclass correlations of the 82-item to shorter versions were high (0.78-0.97), and the amount of between-group differences was comparable using all survey versions. Twelve-month within-group effect sizes ranged narrowly from 0.76 to 1.05 for different survey versions in the PREPARE arm and from 0.44 to 0.64 for the advance directive-only version. Between-group effect sizes ranged narrowly from 0.24 to 0.30 for different survey versions. Results were similar when stratified by English and Spanish speakers.
CONCLUSION


Shorter versions of the ACP Engagement Survey were able to detect within-group and between-group changes comparable with the 82-item version and can be useful for efficiently and effectively measuring ACP engagement in research and clinical settings.",2019,Twelve-month within-group effect sizes ranged narrowly from 0.76 to 1.05 for different Survey versions in the PREPARE arm and from 0.44 to 0.64 for the AD-only.,['986 English- and Spanish-speaking adults'],[],[],"[{'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],[],,0.0318599,Twelve-month within-group effect sizes ranged narrowly from 0.76 to 1.05 for different Survey versions in the PREPARE arm and from 0.44 to 0.64 for the AD-only.,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco, California, USA; San Francisco Veterans Affairs Health Care System, San Francisco, California, USA. Electronic address: Ying.Shi@ucsf.edu.'}, {'ForeName': 'Deborah E', 'Initials': 'DE', 'LastName': 'Barnes', 'Affiliation': 'San Francisco Veterans Affairs Health Care System, San Francisco, California, USA; Department of Psychiatry, University of California, San Francisco, California, USA; Department of Epidemiology & Biostatistics, University of California, San Francisco, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Boscardin', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco, California, USA; Department of Epidemiology & Biostatistics, University of California, San Francisco, California, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'You', 'Affiliation': 'Departments of Medicine, and Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Daren K', 'Initials': 'DK', 'LastName': 'Heyland', 'Affiliation': ""Department of Critical Care Medicine, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Aiesha M', 'Initials': 'AM', 'LastName': 'Volow', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco, California, USA; San Francisco Veterans Affairs Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Howard', 'Affiliation': 'Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sudore', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco, California, USA; San Francisco Veterans Affairs Health Care System, San Francisco, California, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.09.004']
311,31866170,Implementation of Evidence-Based Practice for Benign Paroxysmal Positional Vertigo in the Emergency Department: A Stepped-Wedge Randomized Trial.,"STUDY OBJECTIVE


We evaluated a strategy to increase use of the test (Dix-Hallpike's test [DHT]) and treatment (canalith repositioning maneuver [CRM]) for benign paroxysmal positional vertigo in emergency department (ED) dizziness visits.
METHODS


We conducted a stepped-wedge randomized trial in 6 EDs. The population was visits with dizziness as a principal reason for the visit. The intervention included educational sessions and decision aid materials. Outcomes were DHT or CRM documentation (primary), head computed tomography (CT) use, length of stay, admission, and 90-day stroke events. The analysis was multilevel logistic regression with intervention, month, and hospital as fixed effects and provider as a random effect. We assessed fidelity with monitoring intervention use and semistructured interviews.
RESULTS


We identified 7,635 dizziness visits during 18 months. The DHT or CRM was documented in 1.5% of control visits (45/3,077; 95% confidence interval 1% to 1.9%) and 3.5% of intervention visits (159/4,558; 95% confidence interval 3% to 4%; difference 2%, 95% confidence interval 1.3% to 2.7%). Head CT use was lower in intervention visits compared with control visits (44.0% [1,352/3,077] versus 36.9% [1,682/4,558]). No differences were observed in admission or 90-day subsequent stroke risk. In fidelity evaluations, providers who used the materials typically reported positive clinical experiences but provider engagement was low at facilities without an emergency medicine residency program.
CONCLUSION


These findings provide evidence that an implementation strategy of a benign paroxysmal positional vertigo-focused approach to ED dizziness visits can be successful and safe in promoting evidence-based care. Absolute rates of DHT and CRM use, however, were still low, which relates in part to our broad inclusion criteria for dizziness visits.",2020,"Head CT use was lower in intervention visits compared with control visits (44.0% [1,352/3,077] versus 36.9% [1,682/4,558]).","['benign paroxysmal positional vertigo in emergency department (ED) dizziness visits', 'Benign Paroxysmal Positional Vertigo in the Emergency Department']","[""test (Dix-Hallpike's test [DHT]) and treatment (canalith repositioning maneuver [CRM""]","['Head CT use', 'admission or 90-day subsequent stroke risk', 'DHT or CRM documentation (primary), head computed tomography (CT) use, length of stay, admission, and 90-day stroke events', 'DHT or CRM']","[{'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}]","[{'cui': 'C0202691', 'cui_str': 'Computerized tomography of head'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.159291,"Head CT use was lower in intervention visits compared with control visits (44.0% [1,352/3,077] versus 36.9% [1,682/4,558]).","[{'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Kerber', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Damschroder', 'Affiliation': 'Implementation Pathways, LLC, Ann Arbor, MI.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McLaughlin', 'Affiliation': 'Department of Emergency Medicine, Christus Spohn Health System, Corpus Christi, TX.'}, {'ForeName': 'Devin L', 'Initials': 'DL', 'LastName': 'Brown', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Burke', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Telian', 'Affiliation': 'Department of Otolaryngology, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Tsodikov', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Fagerlin', 'Affiliation': 'Department of Population Health Sciences, University of Utah, Salt Lake City, UT; Salt Lake City VA Center for Informatics Decision Enhancement and Surveillance, Salt Lake City, UT.'}, {'ForeName': 'Lawrence C', 'Initials': 'LC', 'LastName': 'An', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, MI; Center for Health Communication and Research, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Lewis B', 'Initials': 'LB', 'LastName': 'Morgenstern', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor, MI; Department of Emergency Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Forman', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Vijan', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Brigid', 'Initials': 'B', 'LastName': 'Rowell', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Meurer', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor, MI; Department of Emergency Medicine, University of Michigan, Ann Arbor, MI. Electronic address: wmeurer@med.umich.edu.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2019.09.017']
312,30577943,Critical Decision Points for Augmenting Interpersonal Psychotherapy for Depressed Adolescents: A Pilot Sequential Multiple Assignment Randomized Trial.,"OBJECTIVE


Practice parameters recommend systematic assessment of depression symptoms over the course of treatment to inform treatment planning; however, there are currently no guidelines regarding how to use symptom monitoring to guide treatment decisions for psychotherapy. The current study compared two time points (week 4 and week 8) for assessing symptoms during interpersonal psychotherapy for depressed adolescents (IPT-A) and explored four algorithms that use the symptom assessments to select the subsequent treatment.
METHOD


Forty adolescents (aged 12-17 years) with a depression diagnosis began IPT-A with an initial treatment plan of 12 sessions delivered over 16 weeks. Adolescents were randomized to a week 4 or week 8 decision point for considering a change in treatment. Insufficient responders at either time point were randomized a second time to increased frequency of IPT-A (twice per week) or addition of fluoxetine. Measures were administered at baseline and weeks 4, 8, 12, and 16.
RESULTS


The week 4 decision point for assessing response and implementing treatment augmentation for insufficient responders was more efficacious for reducing depression symptoms than the week 8 decision point. There were significant differences between algorithms in depression and psychosocial functioning outcomes.
CONCLUSION


Therapists implementing IPT-A should routinely monitor depression symptoms and consider augmenting treatment for insufficient responders as early as week 4 of treatment.
CLINICAL TRIAL REGISTRATION INFORMATION


An Adaptive Treatment Strategy for Adolescent Depression. https://clinicaltrials.gov; NCT02017535.",2019,"There were significant differences between algorithms in depression and psychosocial functioning outcomes.
","['Depressed Adolescents', 'Adolescent Depression', 'Adolescents', 'Forty adolescents (aged 12-17 years) with a depression diagnosis began IPT-A with an initial treatment plan of 12 sessions delivered over 16 weeks']","['fluoxetine', 'Interpersonal Psychotherapy', 'interpersonal psychotherapy']","['depression symptoms', 'depression and psychosocial functioning outcomes']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy (regime/therapy)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",40.0,0.0492825,"There were significant differences between algorithms in depression and psychosocial functioning outcomes.
","[{'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Gunlicks-Stoessel', 'Affiliation': 'University of Minnesota, MN. Electronic address: mgunlick@umn.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mufson', 'Affiliation': 'Columbia University College of Physicians & Surgeons and New York State Psychiatric Institute, New York, NY.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Bernstein', 'Affiliation': 'University of Minnesota, MN.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Westervelt', 'Affiliation': 'University of Minnesota, MN.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Reigstad', 'Affiliation': 'University of Minnesota, MN.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Klimes-Dougan', 'Affiliation': 'University of Minnesota, MN.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Cullen', 'Affiliation': 'University of Minnesota, MN.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Murray', 'Affiliation': 'University of Minnesota, MN.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vock', 'Affiliation': 'University of Minnesota, MN.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2018.06.032']
313,32223116,Anticoagulation with or without Clopidogrel after Transcatheter Aortic-Valve Implantation.,"BACKGROUND


The roles of anticoagulation alone or with an antiplatelet agent after transcatheter aortic-valve implantation (TAVI) have not been well studied.
METHODS


We performed a randomized trial of clopidogrel in patients undergoing TAVI who were receiving oral anticoagulation for appropriate indications. Patients were assigned before TAVI in a 1:1 ratio not to receive clopidogrel or to receive clopidogrel for 3 months. The two primary outcomes were all bleeding and non-procedure-related bleeding over a period of 12 months. Procedure-related bleeding was defined as Bleeding Academic Research Consortium type 4 severe bleeding, and therefore most bleeding at the puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction at 12 months (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2), both tested for noninferiority (noninferiority margin, 7.5 percentage points) and superiority.
RESULTS


Bleeding occurred in 34 of the 157 patients (21.7%) receiving oral anticoagulation alone and in 54 of the 156 (34.6%) receiving oral anticoagulation plus clopidogrel (risk ratio, 0.63; 95% confidence interval [CI], 0.43 to 0.90; P = 0.01); most bleeding events were at the TAVI access site. Non-procedure-related bleeding occurred in 34 patients (21.7%) and in 53 (34.0%), respectively (risk ratio, 0.64; 95% CI, 0.44 to 0.92; P = 0.02). Most bleeding occurred in the first month and was minor. A secondary composite 1 event occurred in 49 patients (31.2%) receiving oral anticoagulation alone and in 71 (45.5%) receiving oral anticoagulation plus clopidogrel (difference, -14.3 percentage points; 95% CI for noninferiority, -25.0 to -3.6; risk ratio, 0.69; 95% CI for superiority, 0.51 to 0.92). A secondary composite 2 event occurred in 21 patients (13.4%) and in 27 (17.3%), respectively (difference, -3.9 percentage points; 95% CI for noninferiority, -11.9 to 4.0; risk ratio, 0.77; 95% CI for superiority, 0.46 to 1.31).
CONCLUSIONS


In patients undergoing TAVI who were receiving oral anticoagulation, the incidence of serious bleeding over a period of 1 month or 1 year was lower with oral anticoagulation alone than with oral anticoagulation plus clopidogrel. (Funded by the Netherlands Organization for Health Research and Development; POPular TAVI EU Clinical Trials Register number, 2013-003125-28; ClinicalTrials.gov number, NCT02247128.).",2020,"Non-procedure-related bleeding occurred in 34 patients (21.7%) and in 53 (34.0%), respectively (risk ratio, 0.64; 95% CI, 0.44 to 0.92; P = 0.02).","['patients undergoing TAVI who were receiving', 'patients undergoing TAVI who were receiving oral anticoagulation for appropriate indications']","['oral anticoagulation plus clopidogrel', 'transcatheter aortic-valve implantation (TAVI', 'Anticoagulation with or without Clopidogrel', 'oral anticoagulation', 'clopidogrel', 'clopidogrel or to receive clopidogrel']","['bleeding events', 'bleeding', 'bleeding and non-procedure-related bleeding', 'composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction at 12 months (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2), both tested for noninferiority (noninferiority margin, 7.5 percentage points) and superiority', 'Bleeding', 'Most bleeding', 'serious bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3509486', 'cui_str': 'Transcatheter Aortic Valve Implantation'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C3509486', 'cui_str': 'Transcatheter Aortic Valve Implantation'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}]",,0.389161,"Non-procedure-related bleeding occurred in 34 patients (21.7%) and in 53 (34.0%), respectively (risk ratio, 0.64; 95% CI, 0.44 to 0.92; P = 0.02).","[{'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Nijenhuis', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Jorn', 'Initials': 'J', 'LastName': 'Brouwer', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Delewi', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Renicus S', 'Initials': 'RS', 'LastName': 'Hermanides', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Holvoet', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Christophe L F', 'Initials': 'CLF', 'LastName': 'Dubois', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Frambach', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'De Bruyne', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Gert K', 'Initials': 'GK', 'LastName': 'van Houwelingen', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Jan A S', 'Initials': 'JAS', 'LastName': 'Van Der Heyden', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Toušek', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van der Kley', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Buysschaert', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Carl E', 'Initials': 'CE', 'LastName': 'Schotborgh', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Ferdinande', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'van der Harst', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Roosen', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Peper', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Frederick W F', 'Initials': 'FWF', 'LastName': 'Thielen', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Veenstra', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Dean R P P', 'Initials': 'DRPP', 'LastName': 'Chan Pin Yin', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Swaans', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Benno J W M', 'Initials': 'BJWM', 'LastName': 'Rensing', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Arnoud W J', 'Initials': 'AWJ', 'LastName': ""van 't Hof"", 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Timmers', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Kelder', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Pieter R', 'Initials': 'PR', 'LastName': 'Stella', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Baan', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}]",The New England journal of medicine,['10.1056/NEJMoa1915152']
314,31969652,Effectiveness of a socially adapted intervention in reducing social inequalities in adolescence weight. The PRALIMAP-INÈS school-based mixed trial.,"BACKGROUND


A high prevalence of overweight/obesity among low socioeconomic status adolescents contributes to health inequalities. However, evidence-based interventions for reducing social inequalities in adolescent weight are lacking. We aimed to investigate whether strengthened care management for adolescents with low socioeconomic status has an equivalent effect in reducing overweight as standard care management in adolescents with high status.
METHODS


PRALIMAP-INÈS was a multicentre trial including 35 state-run high and middle schools in the north-eastern France. A population-based sample of 1639 adolescents aged 13-18 years with screened and clinically confirmed overweight/obesity were proposed for inclusion and divided into two groups by the Family Affluence Scale score: advantaged (score > 5), receiving standard care management (A.S) and less-advantaged randomly assigned to two groups (1:2 ratio): standard care management (LA.S) and standard and strengthened care management (LA.S.S). Interventions were based on the proportionate universalism principle: universal standard care for all groups and proportionate care for the LA.S.S group. Main outcome was body mass index z-score (BMIz) assessed before and 1 year after inclusion.
RESULTS


A total of 1419 adolescents were included and 1143 followed up at 1 year: 649 in A.S, 158 in LA.S and 336 in LA.S.S groups. BMIz decreased significantly for boys (-0.11 [95% CI, -0.13 to -0.08]; p < 0.0001) and girls (-0.05 [-0.08 to -0.03]; p < 0.0001). No equivalence between LA.S.S and A.S groups was evidenced. For girls, the trend to superiority for LA.S.S was confirmed by the more favourable change (-0.06 [-0.11 to -0.01]; p = 0.01) observed on superiority analysis, with no differential change for boys (0.02 [-0.03 to 0.08]; p = 0.41).
CONCLUSIONS


A public health school-based intervention using the proportionate universalism principle may be effective in not worsening or even reducing overweight social inequalities in adolescents, especially for girls. Overcoming social barriers may help health professionals dealing with the burden and inequalities of overweight in adolescents.",2020,"BMIz decreased significantly for boys (-0.11 [95% CI, -0.13 to -0.08]; p < 0.0001) and girls (-0.05 [-0.08 to -0.03]; p < 0.0001).","['1639 adolescents aged 13-18 years with screened and clinically confirmed overweight/obesity were proposed for inclusion and divided into two groups by the Family Affluence Scale score: advantaged (score\u2009>\u20095), receiving standard care management (A.S) and less-advantaged randomly assigned to two groups (1:2 ratio', 'overweight in adolescents', '35 state-run high and middle schools in the north-eastern France', '1419 adolescents were included and 1143 followed up at 1 year: 649 in A.S, 158 in LA.S and 336 in LA.S.S groups', 'adolescence weight', 'adolescents with high status', 'adolescents with low socioeconomic status']","['standard care management (LA.S) and standard and strengthened care management (LA.S.S', 'socially adapted intervention', 'strengthened care management']","['BMIz', 'body mass index z-score (BMIz', 'social inequalities']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",1639.0,0.048898,"BMIz decreased significantly for boys (-0.11 [95% CI, -0.13 to -0.08]; p < 0.0001) and girls (-0.05 [-0.08 to -0.03]; p < 0.0001).","[{'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Briançon', 'Affiliation': 'University of Lorraine, EA 4360 APEMAC, Nancy Metz, France. serge.briancon@univ-lorraine.fr.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Legrand', 'Affiliation': 'University of Lorraine, EA 4360 APEMAC, Nancy Metz, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Muller', 'Affiliation': 'University of Lorraine, EA 4360 APEMAC, Nancy Metz, France.'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Langlois', 'Affiliation': 'National Conservatory of Arts and Crafts, Nancy, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Saez', 'Affiliation': 'University of Lorraine, EA 4360 APEMAC, Nancy Metz, France.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Spitz', 'Affiliation': 'University of Lorraine, EA 4360 APEMAC, Nancy Metz, France.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Quinet', 'Affiliation': 'Local school office of the Nancy-Metz academy, Nancy, France.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Böhme', 'Affiliation': 'Department of endocrinology, diabetology and nutrition, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Lecomte', 'Affiliation': 'National Conservatory of Arts and Crafts, Nancy, France.'}, {'ForeName': 'Abdou Y', 'Initials': 'AY', 'LastName': 'Omorou', 'Affiliation': 'University of Lorraine, EA 4360 APEMAC, Nancy Metz, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of obesity (2005),['10.1038/s41366-020-0520-z']
315,32124520,Effects of tocolysis with nifedipine or atosiban on child outcome: follow-up of the APOSTEL III trial.,"OBJECTIVE


To compare the long-term effects of tocolysis with nifedipine or atosiban on child outcome at age 2.5-5.5 years.
DESIGN


The APOSTEL III trial was a multicentre randomised controlled trial that compared tocolysis with nifedipine or atosiban in 503 women with threatened preterm birth. Neonatal outcomes did not differ between both treatment arms, except for a higher incidence of intubation in the atosiban group.
METHODS


Parents were asked to complete four questionnaires regarding neurodevelopment, executive function, behaviour problems and general health.
MAIN OUTCOME MEASURES


The main long-term outcome measure was a composite of abnormal development at the age of 2.5-5.5 years.
RESULTS


Of the 426 women eligible for follow-up, 196 (46%) parents returned the questionnaires for 115 children in the nifedipine group and 110 children in the atosiban group. Abnormal development occurred in 32 children (30%) in the nifedipine group and in 38 children (38%) in the atosiban group (OR 0.74, 95% CI 0.41-1.34). The separate outcomes for neurodevelopment, executive function, behaviour, and general health showed no significant differences between the groups. Sensitivity analysis for all children of the APOSTEL III trial, including a comparison of deceased children, resulted in a higher rate of healthy survival in the nifedipine group (64 versus 54%), but there was no significant difference in the overall mortality rate (5.4 versus 2.7%). There were no significant subgroup effects.
CONCLUSION


Outcomes on broad child neurodevelopment, executive function, behaviour and general health were comparable in both groups. Neither nifedipine nor atosiban can be considered as the preferred treatment for women with threatened preterm birth.
TWEETABLE ABSTRACT


Nifedipine- and atosiban-exposed children had comparable long-term outcomes, including neurodevelopment, executive function and behaviour.",2020,"The separate outcomes for neurodevelopment, executive function, behaviour, and general health showed no significant differences between the groups.","['503 women with threatened preterm birth', 'child outcome at age 2.5-5.5 years', 'Parents were asked to complete four questionnaires regarding neurodevelopment, executive function, behaviour problems, and general health', '426 women eligible for follow up', 'women with threatened preterm birth']","['nifedipine', 'nifedipine or atosiban']","['rate of healthy survival', 'neurodevelopment, executive function, behaviour, and general health', 'Abnormal development', 'composite of abnormal development', 'broad child neurodevelopment, executive function, behaviour and general health', 'child outcome', 'overall mortality']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0164398', 'cui_str': 'Atosiban'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",503.0,0.145086,"The separate outcomes for neurodevelopment, executive function, behaviour, and general health showed no significant differences between the groups.","[{'ForeName': 'Tms', 'Initials': 'T', 'LastName': 'van Winden', 'Affiliation': 'Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Klumper', 'Affiliation': 'Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Kleinrouweler', 'Affiliation': 'Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Tichelaar', 'Affiliation': 'Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Naaktgeboren', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Nijman', 'Affiliation': 'Department of Obstetrics and Gynaecology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'van Baar', 'Affiliation': 'Child and Adolescent Studies, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'van Wassenaer-Leemhuis', 'Affiliation': 'Paediatrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Roseboom', 'Affiliation': 'Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': ""Van't Hooft"", 'Affiliation': 'Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roos', 'Affiliation': 'Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pajkrt', 'Affiliation': 'Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Oudijk', 'Affiliation': 'Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16186']
316,32223113,Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery.,"BACKGROUND


Nonmajor orthopedic surgery of the lower limbs that results in transient reduced mobility places patients at risk for venous thromboembolism. Rivaroxaban may be noninferior to enoxaparin with regard to the prevention of major venous thromboembolism in these patients.
METHODS


In this international, parallel-group, randomized, double-blind, noninferiority trial, we randomly assigned adult patients undergoing lower-limb nonmajor orthopedic surgery who were considered to be at risk for venous thromboembolism on the basis of the investigator's judgment to receive either rivaroxaban or enoxaparin. The primary efficacy outcome of major venous thromboembolism was a composite of symptomatic distal or proximal deep-vein thrombosis, pulmonary embolism, or venous thromboembolism-related death during the treatment period or asymptomatic proximal deep-vein thrombosis at the end of treatment. A test for superiority was planned if rivaroxaban proved to be noninferior to enoxaparin. For all outcomes, multiple imputation was used to account for missing data. Prespecified safety outcomes included major bleeding (fatal, critical, or clinically overt bleeding or bleeding at the surgical site leading to intervention) and nonmajor clinically relevant bleeding.
RESULTS


A total of 3604 patients underwent randomization; 1809 patients were assigned to receive rivaroxaban, and 1795 to receive enoxaparin. Major venous thromboembolism occurred in 4 of 1661 patients (0.2%) in the rivaroxaban group and in 18 of 1640 patients (1.1%) in the enoxaparin group (risk ratio with multiple imputation, 0.25; 95% confidence interval, 0.09 to 0.75; P<0.001 for noninferiority; P = 0.01 for superiority). The incidence of bleeding did not differ significantly between the rivaroxaban group and the enoxaparin group (1.1% and 1.0%, respectively, for major bleeding or nonmajor clinically relevant bleeding; 0.6% and 0.7%, respectively, for major bleeding).
CONCLUSIONS


Rivaroxaban was more effective than enoxaparin in the prevention of venous thromboembolic events during a period of immobilization after nonmajor orthopedic surgery of the lower limbs. (Funded by Centre Hospitalier Universitaire de Saint-Etienne and Bayer; PRONOMOS ClinicalTrials.gov number, NCT02401594.).",2020,A test for superiority was planned if rivaroxaban proved to be noninferior to enoxaparin.,"['Nonmajor Orthopedic Surgery', '3604 patients underwent randomization; 1809 patients', ""adult patients undergoing lower-limb nonmajor orthopedic surgery who were considered to be at risk for venous thromboembolism on the basis of the investigator's judgment to receive either""]","['enoxaparin', 'Rivaroxaban', 'Rivaroxaban or Enoxaparin', 'rivaroxaban', 'rivaroxaban or enoxaparin']","['venous thromboembolic events', 'incidence of bleeding', 'major venous thromboembolism was a composite of symptomatic distal or proximal deep-vein thrombosis, pulmonary embolism, or venous thromboembolism-related death during the treatment period or asymptomatic proximal deep-vein thrombosis', 'major bleeding or nonmajor clinically relevant bleeding', 'Major venous thromboembolism', 'major bleeding (fatal, critical, or clinically overt bleeding or bleeding at the surgical site leading to intervention) and nonmajor clinically relevant bleeding']","[{'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",3604.0,0.445584,A test for superiority was planned if rivaroxaban proved to be noninferior to enoxaparin.,"[{'ForeName': 'C Marc', 'Initials': 'CM', 'LastName': 'Samama', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Silvy', 'Initials': 'S', 'LastName': 'Laporte', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Rosencher', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Girard', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Llau', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mouret', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Fisher', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martínez-Martín', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Duverger', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Deygas', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Presles', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Cucherat', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mismetti', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1913808']
317,32212856,Augmenting Computerized Cognitive Training With Vortioxetine for Age-Related Cognitive Decline: A Randomized Controlled Trial.,"OBJECTIVE


Age-related cognitive decline, the deterioration in functions such as memory and executive function, is faced by most older adults and affects function and quality of life. No approved treatments exist for age-related cognitive decline. Computerized cognitive training has been shown to provide consistent albeit modest improvements in cognitive function as measured by neuropsychological testing. Vortioxetine, an antidepressant medication, has putative procognitive and proneuroplastic properties and therefore may be able to augment cognitive training. In this placebo-controlled study, the authors tested the cognitive benefits of vortioxetine added to cognitive training for adults age 65 or older with age-related cognitive decline.
METHODS


After a 2-week lead-in period of cognitive training, 100 participants were randomly assigned to receive either vortioxetine or placebo in addition to cognitive training for 26 weeks. The primary outcome measure was global cognitive performance, assessed by the NIH Toolbox Cognition Battery Fluid Cognition Composite. The secondary outcome measure was functional cognition, assessed by the UCSD Performance-Based Skills Assessment. All participants received motivational messaging and support from study staff to maximize adherence to the training.
RESULTS


Participants who received vortioxetine with cognitive training showed a greater increase in global cognitive performance compared with those who received placebo with cognitive training. This separation was significant at week 12 but not at other assessment time points. Both groups showed improvement in the secondary outcome measure of functional cognition, with no significant difference between groups.
CONCLUSIONS


Vortioxetine may be beneficial for age-related cognitive decline when combined with cognitive training. These findings provide new treatment directions for combating cognitive decline in older adults.",2020,"RESULTS


Participants who received vortioxetine with cognitive training showed a greater increase in global cognitive performance compared with those who received placebo with cognitive training.","['adults age 65 or older with age-related cognitive decline', '100 participants', 'Age-Related Cognitive Decline', 'older adults']","['vortioxetine added to cognitive training', 'Computerized cognitive training', 'Computerized Cognitive Training With Vortioxetine', 'placebo', 'motivational messaging', 'vortioxetine or placebo', 'vortioxetine with cognitive training', 'Vortioxetine']","['cognitive function', 'global cognitive performance, assessed by the NIH Toolbox Cognition Battery Fluid Cognition Composite', 'global cognitive performance', 'functional cognition', 'functional cognition, assessed by the UCSD Performance-Based Skills Assessment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0236848', 'cui_str': 'Age-related cognitive decline (finding)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0729447', 'cui_str': 'Battery fluid (substance)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",100.0,0.154771,"RESULTS


Participants who received vortioxetine with cognitive training showed a greater increase in global cognitive performance compared with those who received placebo with cognitive training.","[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Stevens', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Jill D', 'Initials': 'JD', 'LastName': 'Waring', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Vy T', 'Initials': 'VT', 'LastName': 'Pham', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Haddad', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Shimony', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bowie', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}]",The American journal of psychiatry,['10.1176/appi.ajp.2019.19050561']
318,32108436,Efficacy and Safety of AbobotulinumtoxinA for the Treatment of Hemiparesis in Adults with Lower Limb Spasticity Previously Treated With Other Botulinum Toxins: A Secondary Analysis of a Randomized Controlled Trial.,"OBJECTIVE


To examine the safety and efficacy of abobotulinumtoxinA in patients previously treated with botulinum toxin type A (BoNT-A) products other than abobotulinumtoxinA.
DESIGN


Secondary analysis from a phase 3, double-blind, single-cycle, randomized, placebo-controlled study.
SETTING


Fifty-two centers (11 countries).
PATIENTS


Adults with spastic hemiparesis were randomized (1:1:1) to receive abobotulinumtoxinA 1000 U, 1500 U, or placebo in their affected lower limb.
MAIN OUTCOME MEASUREMENTS


Muscle tone (6-point Modified Ashworth Scale [MAS], 0-5) for the gastrocnemius-soleus complex (GSC); proportion of MAS responders (≥1-point improvement); angle of catch (X V3  ) and spasticity grade (Y) for the GSC and soleus. Assessments were at weeks 1, 4, and 12 post-injection. Only descriptive statistics are presented.
RESULTS


Of 388 patients, 84 received previous BoNT-A treatment (abobotulinumtoxinA 1000 U: N = 30; abobotulinumtoxinA 1500 U: N = 28; placebo: N = 26). At week 4, mean (SD) changes in MAS score in the GSC were - 0.8 (1.1), -0.9 (1.0), and - 0.4 (0.7) for abobotulinumtoxinA 1000 U, 1500 U, and placebo, respectively. Greater MAS responder rates were observed for abobotulinumtoxinA versus placebo at all time points. Mean (SD) changes (week 4) for abobotulinumtoxinA 1000 U, 1500 U, and placebo for X V3  were: GSC, 8° (21), 6° (10) and 1° (7); soleus, 11° (21), 5° (9) and 0° (8), respectively; for Y: GSC, -0.4 (0.7), -0.6 (0.8) and - 0.0 (0.9); soleus, -0.5 (0.7), -0.5 (0.7) and - 0.1 (0.6), respectively. Safety data and adverse events were consistent with the overall known profile of abobotulinumtoxinA.
CONCLUSIONS


Patients previously treated with other BoNT-As showed improved muscle tone and spasticity at week 4 following abobotulinumtoxinA injection versus placebo. These findings suggest that abobotulinumtoxinA, at the recommended doses, has a good safety and efficacy profile in adults with lower limb spasticity who were previously treated with other BoNT-A products.",2020,Greater MAS responder rates were observed for abobotulinumtoxinA vs placebo at all time points.,"['adults with lower limb spasticity (LLS', '52 centers (11 countries', 'adults with LLS', 'hemiparesis in adults with lower limb spasticity previously treated with', 'patients previously treated with', '388 patients', 'Adults with spastic hemiparesis']","['abobotulinumtoxinA', 'placebo', 'abobotulinumtoxinA injection vs placebo', 'botulinum toxin type A (BoNT-A', 'abobotulinumtoxinA vs placebo', 'abobotulinumtoxinA 1500\u2009U: N\u2009=\u200928; placebo', 'previous BoNT-A treatment (abobotulinumtoxinA 1000\u2009U: N\u2009=\u200930', 'botulinum toxin', 'abobotulinumtoxinA 1000\u2009U, 1500\u2009U or placebo']","['Efficacy and safety', 'Safety data and adverse events', 'Mean (SD) changes', 'Muscle tone (6-point Modified Ashworth Scale [MAS], 0-5) for the gastrocnemius-soleus complex (GSC); proportion of MAS responders (≥1 point improvement); angle of catch (X V3  ) and spasticity grade (Y) for GSC and soleus', 'muscle tone and spasticity', 'Greater MAS responder rates', 'mean (SD) changes in MAS score in GSC']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1271100', 'cui_str': 'Lower limb spasticity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0457436', 'cui_str': 'Left hemiparesis (disorder)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0154694', 'cui_str': 'Hemiplegia, Spastic'}]","[{'cui': 'C2719424', 'cui_str': 'abobotulinumtoxinA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0549465', 'cui_str': 'Muscle tone (observable entity)'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0231617', 'cui_str': 'Catch (finding)'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.582084,Greater MAS responder rates were observed for abobotulinumtoxinA vs placebo at all time points.,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Esquenazi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, MossRehab Gait and Motion Analysis Laboratory, Elkins Park, PA, USA.'}, {'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Stoquart', 'Affiliation': 'Physical and Rehabilitation Medicine Department, Cliniques universitaires Saint-Luc, Catholic University of Louvain, Brussels, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hedera', 'Affiliation': 'Department of Neurology, Division of Movement Disorders, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Luis Jorge', 'Initials': 'LJ', 'LastName': 'Jacinto', 'Affiliation': 'Centro de Medicina de Reabilitação de Alcoitão, Estoril, Estoril, Portugal.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Dimanico', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Constant-Boyer', 'Affiliation': 'Unités de Médecine Physique et de Réadaptation, Hôpital Sébastopol, Université de Reims Champagne-Ardenne, Reims, France.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Brashear', 'Affiliation': 'School of Medicine, University of California, Davis, Sacramento, CA.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Grandoulier', 'Affiliation': 'Biostatistics, Ipsen Pharma, Les Ulis, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Vilain', 'Affiliation': 'Medical Affairs, Les Ulis, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Picaut', 'Affiliation': 'Medical Affairs, Les Ulis, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Gracies', 'Affiliation': 'Service de Rééducation Neurolocomotrice, EA 7377 BIOTN, Université Paris-Est, Hospital Albert Chenevier-Henri Mondor, Créteil, France.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12348']
319,31338716,Effectiveness of Peer-Delivered Trauma Treatment in a Rural Community: A Randomized Non-inferiority Trial.,"This randomized controlled non-inferiority trial explored the effectiveness of Seeking Safety (SS) delivered by peer providers compared to its delivery by licensed behavioral health clinicians. The study enrolled 291 adults with PTSD and/or substance use disorders. Data were collected at 3 and 6-months post start of treatment. With respect to long-term outcomes, at 6 months PTSD symptoms decreased by 5.1 points [95% CI (- 9.0, - 1.1)] and by 4.9 points [95% CI (- 8.6, - 1.1)] and coping skills increased by 5.5 points [95% CI (0.4, 10.6)] and by 5.6 points [95% CI (0.8, 10.4)], in the peer- and clinician-led groups, respectively. This study demonstrated non-inferiority of peer-delivered SS compared to clinician-delivered SS for reducing PTSD symptoms and similar outcomes for both groups with respect to coping skills. A confirmatory study on the effectiveness of peer-delivered trauma-specific services is warranted, especially given the potential for increasing access to such treatment in underserved rural communities.",2019,This study demonstrated non-inferiority of peer-delivered SS compared to clinician-delivered SS for reducing PTSD symptoms and similar outcomes for both groups with respect to coping skills.,"['291 adults with PTSD and/or substance use disorders', 'underserved rural communities', 'a Rural Community']","['Peer-Delivered Trauma Treatment', 'Seeking Safety (SS']","['coping skills', 'PTSD symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}]","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",291.0,0.0804618,This study demonstrated non-inferiority of peer-delivered SS compared to clinician-delivered SS for reducing PTSD symptoms and similar outcomes for both groups with respect to coping skills.,"[{'ForeName': 'Annette S', 'Initials': 'AS', 'LastName': 'Crisanti', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of New Mexico, MSC 09 5030, Albuquerque, NM, 87131, USA. acrisanti@salud.unm.edu.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Murray-Krezan', 'Affiliation': 'Department of Internal Medicine, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Reno', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of New Mexico, MSC 09 5030, Albuquerque, NM, 87131, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Killough', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of New Mexico, MSC 09 5030, Albuquerque, NM, 87131, USA.'}]",Community mental health journal,['10.1007/s10597-019-00443-3']
320,32222255,Heart Rate Determination in Newborns at Risk for Resuscitation in a Low-Resource Setting: A Randomized Controlled Trial.,"OBJECTIVE


To compare 2 different methods (auscultation with a stethoscope and umbilical cord palpation) of heart rate (HR) estimation in newborns at risk for resuscitation in a low-resource setting.
STUDY DESIGN


Sixty newborns at risk for resuscitation born at the St. Luke Catholic Hospital in Wolisso (Ethiopia) were randomized to HR assessment by auscultation using a stethoscope or umbilical cord palpation. HR was assessed at 60, 90, 120 seconds, and 5 minutes of life. The primary outcome was the agreement of HR obtained by auscultation or palpation compared with the HR determined by electrocardiogram.
RESULTS


Mean difference between auscultation using a stethoscope and electrocardiogram was -13 bpm, -4 bpm, -6 bpm, and -10 bpm at 60, 90, 120 seconds, and at 5 minutes of life. Mean difference between palpation and electrocardiogram of was -20 bpm, -25 bpm, -23 bpm, and -31 bpm at 60, 90, 120 seconds, and at 5 minutes of life. The magnitude of the difference between auscultation and electrocardiogram was lower than that between palpation and electrocardiogram over time (P = .007). HR range was correctly identified in 14 out of 16 measurements (87%) with HR <100 bpm.
CONCLUSION


HR assessment by auscultation was more accurate compared with cord palpation, but both may provide adequate clinical information to healthcare providers in terms of HR ranges. The clinical advantage of providing a stethoscope in low-resource settings remains to be established.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03854435.",2020,The magnitude of the difference between auscultation and electrocardiogram was lower than that between palpation and electrocardiogram over time,"['Newborns at Risk for Resuscitation in a Low-Resource Setting', 'Sixty newborns at risk for resuscitation born at the St. Luke Catholic Hospital in Wolisso (Ethiopia', 'newborns at risk for resuscitation in a low-resource setting']","['methods (auscultation with a stethoscope and umbilical cord palpation', 'HR assessment by auscultation using a stethoscope or umbilical cord palpation']","['agreement of HR obtained by auscultation or palpation compared with the HR determined by electrocardiogram', 'heart rate (HR) estimation', 'HR range']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0183559', 'cui_str': 'Stethoscopes'}, {'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",,0.112529,The magnitude of the difference between auscultation and electrocardiogram was lower than that between palpation and electrocardiogram over time,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cavallin', 'Affiliation': 'Independent statistician, Solagna, Italy.'}, {'ForeName': 'Maria Sofia', 'Initials': 'MS', 'LastName': 'Cori', 'Affiliation': 'Department of Woman and Child Health, Università Cattolica del Sacro Cuore, Roma, Italy.'}, {'ForeName': 'Senait', 'Initials': 'S', 'LastName': 'Negash', 'Affiliation': 'Department of Pediatrics, St. Luke Catholic Hospital, Wolisso, Ethiopia.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Azzimonti', 'Affiliation': 'Research Office, Doctors with Africa CUAMM, Wolisso, Ethiopia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Vento', 'Affiliation': 'Department of Woman and Child Health, Università Cattolica del Sacro Cuore, Roma, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Putoto', 'Affiliation': 'Research Office, Doctors with Africa CUAMM, Padova, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Trevisanuto', 'Affiliation': ""Department of Woman's and Child's Health, University of Padova, Padova, Italy. Electronic address: daniele.trevisanuto@unipd.it.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.02.026']
321,29728704,The novel ghrelin receptor inverse agonist PF-5190457 administered with alcohol: preclinical safety experiments and a phase 1b human laboratory study.,"Rodent studies indicate that ghrelin receptor blockade reduces alcohol consumption. However, no ghrelin receptor blockers have been administered to heavy alcohol drinking individuals. Therefore, we evaluated the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and behavioral effects of a novel ghrelin receptor inverse agonist, PF-5190457, when co-administered with alcohol. We tested the effects of PF-5190457 combined with alcohol on locomotor activity, loss-of-righting reflex (a measure of alcohol sedative actions), and on blood PF-5190457 concentrations in rats. Then, we performed a single-blind, placebo-controlled, within-subject human study with PF-5190457 (placebo/0 mg b.i.d., 50 mg b.i.d., 100 mg b.i.d.). Twelve heavy drinkers during three identical visits completed an alcohol administration session, subjective assessments, and an alcohol cue-reactivity procedure, and gave blood samples for PK/PD testing. In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex. Alcohol did not affect blood PF-5190457 concentrations. In humans, all adverse events were mild or moderate and did not require discontinuation or dose reductions. Drug dose did not alter alcohol concentration or elimination, alcohol-induced stimulation or sedation, or mood during alcohol administration. Potential PD markers of PF-5190457 were acyl-to-total ghrelin ratio and insulin-like growth factor-1. PF-5190457 (100 mg b.i.d.) reduced alcohol craving during the cue-reactivity procedure. This study provides the first translational evidence of safety and tolerability of the ghrelin receptor inverse agonist PF-5190457 when co-administered with alcohol. PK/PD/behavioral findings support continued research of PF-5190457 as a potential pharmacological agent to treat alcohol use disorder.",2020,"In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex.","['rats', 'Twelve heavy drinkers']","['PF-5190457', 'placebo', 'PF-5190457 (placebo/0', 'ghrelin receptor inverse agonist', 'PF-5190457 combined with alcohol']","['reduced alcohol craving', 'alcohol consumption', 'locomotor activity, loss-of-righting reflex', 'safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and behavioral effects', 'alcohol concentration or elimination, alcohol-induced stimulation or sedation, or mood', 'blood PF-5190457 concentrations', 'locomotor activity or loss-of-righting reflex']","[{'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}]","[{'cui': 'C4279098', 'cui_str': 'PF-5190457'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0391690', 'cui_str': 'GHSR Protein'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0234156', 'cui_str': 'Righting Response'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005768'}, {'cui': 'C4279098', 'cui_str': 'PF-5190457'}]",,0.0182118,"In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex.","[{'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Lee', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jenica D', 'Initials': 'JD', 'LastName': 'Tapocik', 'Affiliation': 'Section on Molecular Pathophysiology, Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mwlod', 'Initials': 'M', 'LastName': 'Ghareeb', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Schwandt', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Alexandra A', 'Initials': 'AA', 'LastName': 'Dias', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'April N', 'Initials': 'AN', 'LastName': 'Le', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Enoch', 'Initials': 'E', 'LastName': 'Cobbina', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Farinelli', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bouhlal', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farokhnia', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Section on Molecular Pathophysiology, Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Akhlaghi', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Leggio', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA. lorenzo.leggio@nih.gov.'}]",Molecular psychiatry,['10.1038/s41380-018-0064-y']
322,31528838,Interactions of the DASH Diet with the Renin-Angiotensin-Aldosterone System.,"Background


The Dietary Approaches to Stop Hypertension (DASH) diet is widely recommended to lower blood pressure, but its mechanisms of action are unclear. Lines of evidence suggest an interaction with the renin-angiotensin-aldosterone system (RAAS).
Objective


We conducted a randomized, controlled, cross-over feeding trial to test RAAS-related mechanisms underlying the DASH diet in patients with isolated systolic hypertension.
Methods


Participants entered a 1-wk run-in period on a control (CON) diet and then consumed the DASH or CON diets for 4 wk each in randomized sequence. Calorie content was controlled to maintain weight, and sodium intake was set at 3 g daily. After each diet, participants had hormonal and hemodynamic assessments obtained at baseline, in response to RAAS inhibition with captopril (CAP) 25 mg, and to graded angiotensin II (AngII) infusions (1 ng/kg and 3 ng/kg × 45 min). Primary outcomes were mean arterial pressure (MAP) and renal blood flow (RBF), and secondary outcomes were diastolic function, pulse wave velocity (PWV), plasma renin activity (PRA), and aldosterone (ALDO) responses by diet.
Results


In total, 44 (19 female) participants completed the study. DASH + CAP significantly lowered MAP compared with CON + CAP (83 ± 11 mmHg compared with 88 ± 14 mmHg,  P  <0.01). RBF was increased with DASH + CAP compared with CON + CAP (486 ± 149 cc/min compared with 451 ± 171 cc/min,  P  <0.001). Study diet did not change PWV but CAP reduced diastolic function on the DASH diet ( P  <0.05). DASH + CAP significantly increased PRA compared with CON + CAP (1.52 ± 1.78 ng/mL/min compared with 0.89 ± 1.17 ng/mL/min;  P  <0.001). ALDO sensitivity to AngII infusion was greater with DASH when compared to CON (17.4 ± 7.7 ng/mL compared with 13.8 ± 6.2 ng/dL,  P  <0.05) as was DASH + CAP compared with CON + CAP (15.1 ± 5.3 ng/dL compared with 13.1 ± 5.9 ng/mL,  P  <0.05).
Conclusions


The DASH diet interacts with the RAAS resulting in vascular and hormonal responses similar to a natriuretic effect, which appears to augment the hypotensive effect of angiotensin-converting enzyme (ACE) inhibition in individuals with isolated systolic hypertension. This trial was registered at clinicaltrials.gov as NCT00123006.",2019,Study diet did not change PWV but CAP reduced diastolic function on the DASH diet ( P  <0.05).,"['patients with isolated systolic hypertension', 'In total, 44 (19 female) participants completed the study', 'individuals with isolated systolic hypertension']","['captopril (CAP) 25 mg, and to graded angiotensin II (AngII) infusions', 'CON\xa0+\xa0CAP', 'DASH diet', 'DASH Diet with the Renin-Angiotensin-Aldosterone System', 'control (CON) diet and then consumed the DASH or CON diets', 'CON', 'angiotensin-converting enzyme (ACE) inhibition']","['ALDO sensitivity to AngII infusion', 'RBF', 'PRA', 'mean arterial pressure (MAP) and renal blood flow (RBF), and secondary outcomes were diastolic function, pulse wave velocity (PWV), plasma renin activity (PRA), and aldosterone (ALDO) responses by diet', 'diastolic function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221155', 'cui_str': 'Systolic hypertension (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0745133', 'cui_str': 'Isolated systolic hypertension'}]","[{'cui': 'C0984502', 'cui_str': 'Captopril 25 MG'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches To Stop Hypertension Diet'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0201888', 'cui_str': 'Peptidyl dipeptidase A measurement (procedure)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C1527409', 'cui_str': 'Renal blood flow, function (observable entity)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]",,0.0781879,Study diet did not change PWV but CAP reduced diastolic function on the DASH diet ( P  <0.05).,"[{'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maris', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital & Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Williams', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital & Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital & Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital & Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Gary F', 'Initials': 'GF', 'LastName': 'Mitchell', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital & Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Conlin', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital & Harvard Medical School, Boston, MA, USA.""}]",Current developments in nutrition,['10.1093/cdn/nzz091']
323,32106558,The Effects on Inappropriate Weight for Gestational Age of an SMS Based Educational Intervention for Pregnant Women in Xi'an China: A Quasi-Randomized Controlled Trial.,"BACKGROUND


The aim of this study was to estimate the effects of maternal text messages on inappropriate weight for gestational age (IWGA) in newborns in rural China.
METHODS


Participants were pregnant women presenting for antenatal care at a Maternal and Child Health Center in Xi'an, China during the 2013-2015 period. In total, 2115 women completed the program with follow-up information included in the final analyses. All mothers were divided into four groups, including (1) a control group that received only a few ""Basic"" messages, (2) a Care-Seeking (CS) message group, (3) Good Household Prenatal Practices (GHPP) message group, and (4) a group receiving all 148 text messages. The primary outcome was IWGA, including small for gestational age (SGA) and macrosomia (weighing ≥4000g at birth). Multivariable logistic regression using an intent-to-treat estimate was utilized.
RESULTS


In total, 19.5% of newborns were IWGA. The risk of IWGA was 23.0% in the control group, 19.6% in the CS group, 18.9% in the GHPP group, and 16.5% in the group with All Texts. Compared to the control group, the odds ratio of IWGA was 0.65 (0.48-0.89) for the group receiving All Texts, which remained statistically significant after performing the Holm-Bonferroni correction. The odds ratio of macrosomia was 0.54 (0.34-0.87) and 0.57 (0.36-0.49) for the Care Seeking message group and the All Texts group, respectively, with statistical significance.
CONCLUSION


A package of free informational text messages, including advice for good household prenatal practices and care seeking, may prevent the inappropriate weight for gestational age through a protective effect on macrosomia. Advice to encourage care seeking in pregnancy may prevent macrosomia among neonates in rural China as well.",2020,"The risk of IWGA was 23.0% in the control group, 19.6% in the CS group, 18.9% in the GHPP group, and 16.5% in the group with All Texts.","[""Participants were pregnant women presenting for antenatal care at a Maternal and Child Health Center in Xi'an, China during the 2013-2015 period"", 'newborns in rural China', ""Pregnant Women in Xi'an China"", '2115 women completed the program with follow-up information included in the final analyses']","['maternal text messages', 'SMS Based Educational Intervention', 'GHPP', 'control group that received only a few ""Basic"" messages, (2) a Care-Seeking (CS) message group, (3) Good Household Prenatal Practices (GHPP) message group, and (4) a group receiving all 148 text messages']","['inappropriate weight for gestational age (IWGA', 'risk of IWGA', 'IWGA, including small for gestational age (SGA) and macrosomia (weighing ≥4000g at birth', 'odds ratio of macrosomia', 'odds ratio of IWGA']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0020052', 'cui_str': 'Households'}]","[{'cui': 'C3542467', 'cui_str': 'Inappropriate component (foundation metadata concept)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0158915', 'cui_str': 'Birth weight 4500 grams OR more'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",2115.0,0.0657184,"The risk of IWGA was 23.0% in the control group, 19.6% in the CS group, 18.9% in the GHPP group, and 16.5% in the group with All Texts.","[{'ForeName': 'Zhongliang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""School of Public Policy and Administration, Xi'an Jiaotong University, Xi'an, Shaanxi 710049, China.""}, {'ForeName': 'Yanfang', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'School of Medicine, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Heitner', 'Affiliation': 'Aceso Global, Washington, DC 20036, USA.'}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Si', 'Affiliation': 'School of Risk and Actuarial Studies and CEPAR, University of New South Wales, Sydney, NSW 2052, Australia.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""School of Public Policy and Administration, Xi'an Jiaotong University, Xi'an, Shaanxi 710049, China.""}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, China.""}, {'ForeName': 'Changzheng', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': ""The Children's Hospital and School of Public Health, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310058, China.""}]",International journal of environmental research and public health,['10.3390/ijerph17051482']
324,32102909,Mouth-Level Nicotine Intake Estimates from Discarded Filter Butts to Examine Compensatory Smoking in Low Nicotine Cigarettes.,"BACKGROUND


A mandated reduction in the nicotine content of cigarettes could reduce smoking rate and prevalence. However, one concern is that smokers may compensate by increasing the intensity with which they smoke each cigarette to obtain more nicotine. This study assessed whether smokers engage in compensatory smoking by estimating the mouth-level nicotine intake of low nicotine cigarettes smoked during a clinical trial.
METHODS


Smokers were randomly assigned to receive cigarettes with one of five nicotine contents for 6 weeks. An additional group received a cigarette with the lowest nicotine content, but an increased tar yield. The obtained mouth-level nicotine intake from discarded cigarette butts for a subset of participants (51-70/group) was estimated using solanesol as described previously. A compensation index was calculated for each group to estimate the proportion of nicotine per cigarette recovered through changes in smoking intensity.
RESULTS


There was no significant increase in smoking intensity for any of the reduced nicotine cigarettes as measured by the compensation index (an estimated 0.4% of the nicotine lost was recovered in the lowest nicotine group; 95% confidence interval, -0.1 to 1.2). There was a significant decrease in smoking intensity for very low nicotine content cigarettes with increased tar yield.
CONCLUSIONS


Reductions in nicotine content did not result in compensatory changes in how intensively participants smoked research cigarettes.
IMPACT


Combined with data from clinical trials showing a reduction in cigarettes smoked per day, these data suggest that a reduction in nicotine content is unlikely to result in increased smoke exposure.",2020,"There was no significant increase in smoking intensity for any of the reduced nicotine cigarettes as measured by the compensation index (an estimated 0.4% of the nicotine lost was recovered in the lowest nicotine group; 95% confidence interval, -0.1 to 1.2).","['Smokers', 'Low Nicotine Cigarettes', 'smokers engage in compensatory smoking by estimating the mouth-level nicotine intake of low nicotine cigarettes smoked during a clinical trial']",[],"['smoking intensity', 'compensation index']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke (substance)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]",[],"[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.024571,"There was no significant increase in smoking intensity for any of the reduced nicotine cigarettes as measured by the compensation index (an estimated 0.4% of the nicotine lost was recovered in the lowest nicotine group; 95% confidence interval, -0.1 to 1.2).","[{'ForeName': 'Tracy T', 'Initials': 'TT', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, and Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina. smithtra@musc.edu.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Koopmeiners', 'Affiliation': 'Division of Biostatistics, School of Public Health, and Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Department of Psychiatry and Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Katelyn M', 'Initials': 'KM', 'LastName': 'Tessier', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Departments of Medicine and Bioengineering & Therapeutic Sciences, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'Department of Biochemistry Molecular Biology and BioPhysics and Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Strasser', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, and Abraham Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Blount', 'Affiliation': 'Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Valentin', 'Affiliation': 'Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Bravo Cardenas', 'Affiliation': 'Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Watson', 'Affiliation': 'Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Pirkle', 'Affiliation': 'Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-0905']
325,31782193,Naloxone Administration by Untrained Community Members.,"STUDY OBJECTIVE


Access to naloxone is a priority for reducing opioid deaths. Although community members who complete naloxone training are able to administer nasal naloxone successfully and rapidly, little is known about the ability of community members to administer naloxone without training. The objective of this study was to assess the ability of untrained individuals to administer naloxone successfully in a simulated opioid overdose setting.
DESIGN


Prospective single-site open-label randomized usability assessment.
SETTING


Scenario station at a large state fair during August and September 2017.
PARTICIPANTS


A total of 207 healthy adults who were randomly assigned to administer naloxone using a nasal spray (NS) device (69 participants), an intramuscular (IM) kit (68 participants), or an improvised nasal atomizer (AT) kit (70 participants).
INTERVENTION


Participants were instructed to administer the device to a high-fidelity mannequin in a public environment with distractions to mimic those that might be present in an actual overdose. No device instructions or administration materials were provided.
MEASUREMENTS AND MAIN RESULTS


Participants were assessed by trained study team members who directly observed all naloxone administrations using the predetermined end-point criteria. Individual participant perceptions were evaluated immediately following the naloxone administration using a standardized questionnaire form. The primary outcome was successful administration, defined as administration within 7 minutes and without critical errors. Secondary outcomes were time to successful naloxone administration and ease of use of the device. The NS (66.7%, p<0.001) and IM (51.5%, p<0.001) devices had higher rates of successful administration than the improvised nasal AT device (2.9%). The NS device was administered more rapidly (median 16 sec) than the IM device (median 58 sec, p<0.001) or improvised nasal AT device (median 113 sec, p=0.012) devices, and it was the easiest to use.
CONCLUSION


In this study of naloxone administration, participants administered the NS and IM devices more successfully than the AT device. The NS device was administered most rapidly and was easiest to use.",2020,"The NS device was administered more rapidly (median 16 seconds) than the IM device (median 58 seconds, p<0.001) or improvised nasal atomizer device (median 113 seconds, p=0.012) devices, and was the easiest to use.
","['untrained individuals', 'Untrained Community Members', 'Two hundred seven healthy adults', 'Scenario station at a large state fair during August and September 2017']","['Naloxone', 'naloxone using a nasal spray (NS) device (69 participants), an intramuscular (IM) kit (68 participants), or an improvised nasal atomizer (AT) kit', 'naloxone', 'naloxone training']","['successful administration, defined as administration within 7 minutes and without critical errors', 'time to successful naloxone administration and ease of use of the device']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C2911689', 'cui_str': 'Fair'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0004185', 'cui_str': 'Atomizers'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",207.0,0.0936364,"The NS device was administered more rapidly (median 16 seconds) than the IM device (median 58 seconds, p<0.001) or improvised nasal atomizer device (median 113 seconds, p=0.012) devices, and was the easiest to use.
","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Eggleston', 'Affiliation': 'Department of Pharmacy Practice, Binghamton University School of Pharmacy and Pharmaceutical Sciences, Binghamton, New York.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Calleo', 'Affiliation': 'Department of Emergency Medicine, SUNY Upstate Medical University, Syracuse, New York.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, SUNY Upstate Medical University, Syracuse, New York.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Wojcik', 'Affiliation': 'Department of Emergency Medicine, SUNY Upstate Medical University, Syracuse, New York.'}]",Pharmacotherapy,['10.1002/phar.2352']
326,31595867,"Spatial Effects of Permethrin-Impregnated Bed Nets on Child Mortality: 26 Years on, a Spatial Reanalysis of a Cluster Randomized Trial.","In addition to the direct effect of insecticide-treated nets (ITNs), there has been evidence for spatial indirect effects. Spatial analyses in cluster randomized trials (CRTs) are rare, but a large-scale CRT from 1993 was one of the first to conduct a spatial analysis of ITNs in CRTs. We revisit these data by applying a broader range of contemporary spatial methods to further explore spatial spillover. We conducted three analyses: 1) exploratory spatial analysis, considering spatial patterns and spillover in the data; 2) spatial modeling, estimating the intervention effect considering spatial effects; and 3) analysis of distance-based spillover and interaction with the intervention, characterizing the functional distance over which the spillover effect was present. There were consistent indications of spatial patterns from the exploratory analysis. Bed nets were associated with a 17% reduction in all-cause mortality for children aged 6-59 months, and the intervention estimate remained robust when allowing for the spatial structure of the data. There was strong evidence of a spatial spillover effect: for every additional 100 m that a control household was from an intervention household (and vice versa), the standardized mortality ratio (SMR) increased by 1.7% (SMR 1.017, 95% credible interval 1.006-1.026). Despite evidence of a spatial spillover effect, the conclusions of the trial remain unaffected by spatial model specifications. Use of ITNs was clearly beneficial for individuals, and there was compelling evidence that they provide an indirect benefit to individuals living nearby. This article demonstrates the extra utility that spatial methods can provide when analyzing a CRT.",2019,"Bed nets were associated with a 17% reduction in all-cause mortality for children aged 6-59 months, and the intervention estimate remained robust when allowing for the spatial structure of the data.",[],"['Permethrin-Impregnated Bed Nets', 'insecticide-treated nets (ITNs']","['standardized mortality ratio (SMR', 'Child Mortality']",[],"[{'cui': 'C0070455', 'cui_str': 'Permethrin'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0021576', 'cui_str': 'Insecticides'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0008083', 'cui_str': 'Child Mortality'}]",,0.184522,"Bed nets were associated with a 17% reduction in all-cause mortality for children aged 6-59 months, and the intervention estimate remained robust when allowing for the spatial structure of the data.","[{'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Jarvis', 'Affiliation': 'MRC London Hub for Trials Methodology Research, London, United Kingdom.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Multerer', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Binka', 'Affiliation': 'School of Public Health, University of Health and Allied Sciences, Ho, Ghana.'}, {'ForeName': 'W John', 'Initials': 'WJ', 'LastName': 'Edmunds', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Smith', 'Affiliation': 'University of Basel, Basel, Switzerland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0111']
327,31361682,Are Continuous Femoral Nerve Catheters Beneficial for Pain Management After Operative Fixation of Tibial Plateau Fractures? A Randomized Controlled Trial.,"OBJECTIVE


To determine whether a continuous femoral nerve block after open reduction internal fixation of tibial plateau fractures would diminish Visual Analog Scale (VAS) scores and/or systemic narcotic intake.
DESIGN


Randomized controlled trial.
SETTING


Level 1 academic trauma center.
PATIENTS


Forty-two consecutive patients with operatively treated tibial plateau fractures.
INTERVENTION


Continuous femoral nerve catheter for postoperative pain management was performed in the experimental group.
MAIN OUTCOME MEASURES


Both the VAS scores for pain and narcotic intake were assessed at 4, 8, 12, 24, 36, 48, and 72 hours postoperatively.
RESULTS


Forty-two patients were enrolled in this study. There were 21 women and 21 men 21-70 years of age (avg 49) with operatively treated tibial plateau fractures. Twenty-one patients were randomized to receive a femoral nerve block with 5 crossovers for technical reasons. Accordingly, we analyzed 16 patients with femoral nerve blocks and 26 with standard care. There were no significant differences between the study groups regarding age, sex, or fracture type. There was no significant difference in VAS scores between the control and experimental group at any time point. The total systemic morphine equivalent for the femoral nerve block group and the control group was 375 and 397 respectively (P = 0.76). Across groups, patients with bicondylar fractures tended to have higher VAS than those with unicondylar fractures and to use more narcotics, although neither was statistically significant.
CONCLUSION


Femoral nerve blocks for postoperative pain management in tibial plateau fractures did not demonstrate an improvement in pain relief or narcotic use.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2019,"CONCLUSION


Femoral nerve blocks for post-operative pain management in tibial plateau fractures did not demonstrate an improvement in pain relief or narcotic use.
","['21 women and 21 men 21-70 years of age (Avg 49) with operatively treated tibial plateau fractures', 'tibial plateau fractures', 'Forty-two patients were enrolled in this study', '16 patients with femoral nerve blocks and 26 with standard care', ' Forty-two consecutive patients with operatively treated tibial plateau fractures INTERVENTION']","['femoral nerve block with 5 crossovers for technical reasons', 'Continuous femoral nerve catheter for post-operative pain management', 'Femoral nerve blocks']","['VAS scores', 'visual analog score (VAS) for pain and narcotic intake', 'pain relief or narcotic use', 'total systemic morphine equivalent']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0584640', 'cui_str': 'Tibial plateau structure (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block (procedure)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0015808', 'cui_str': 'Femoral Nerve'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]",42.0,0.129248,"CONCLUSION


Femoral nerve blocks for post-operative pain management in tibial plateau fractures did not demonstrate an improvement in pain relief or narcotic use.
","[{'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Cooke', 'Affiliation': 'Department of Orthopaedic Surgery, Boston University, Boston, MA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Welch', 'Affiliation': ''}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Gusakov', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Tornetta', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001594']
328,31178170,Effect of JJ stent on outcomes of extracorporeal shock wave lithotripsy treatment of moderate sized renal pelvic stones: A randomized prospective study.,"PURPOSE


To evaluate the effect of JJ stents on SWL treatment of moderate (15-25mm) renal pelvic stones.
MATERIALS AND METHODS


Between January 2016 and December 2017, a total of 152 adult patients who were planned to undergo SWL for a single radiopaque renal pelvic stone were included in the study. Patients with solitary kidney, congenital abnormality, skeletal tract abnormalities, previous urinary system surgery, hydronephrosis (grade 2 or more), untreated urinary tract infection, bleeding disorder, and suspected pregnancy were excluded. The remaining 114 patients were randomly divided into two groups; non-stented and stented. Twenty-two patients whose stone could not be fragmented despite 3 consecutive sessions were also excluded from the study. A total of 92 patients (54 non-stented and 38 stented) were included in the final analysis.
RESULTS


There was no significant difference in terms of age, sex, body mass index, renal parancyhimal thickness, hydronephrosis, skin-to-stone distance, Hounsfield units, and stone size between the groups. Success was significantly higher in the stented group than in the non-stented group (71% vs. 39%, P=.002). In stone-free patients, the number of emergency department visits and analgesic tablet consumption was significantly lower in the stented group than in the non-stented group (P<.001 and P<.001, respectively). In non- stone-free patients, analgesic tablet consumption was significantly lower in the stented group than in the non-stented group (P=.004).
CONCLUSIONS


Pre-stenting before SWL treatment of moderate sized renal pelvic stones has some advantages in terms of success, emergency service visits, and analgesic tablet consumption.",2019,"In stone-free patients, the number of emergency department visits and analgesic tablet consumption was significantly lower in the stented group than in the non-stented group (P<.001 and P<.001, respectively).","['moderate (15-25mm) renal pelvic stones', '114 patients', 'Patients with solitary kidney, congenital abnormality, skeletal tract abnormalities, previous urinary system surgery, hydronephrosis (grade 2 or more), untreated urinary tract infection, bleeding disorder, and suspected pregnancy were excluded', '92 patients (54 non-stented and 38 stented) were included in the final analysis', 'Between January 2016 and December 2017, a total of 152 adult patients who were planned to undergo SWL for a single radiopaque renal pelvic stone were included in the study', 'Twenty-two patients whose stone could not be fragmented despite 3 consecutive sessions were also excluded from the study', 'moderate sized renal pelvic stones']","['JJ stent', 'JJ stents', 'extracorporeal shock wave lithotripsy treatment']","['number of emergency department visits and analgesic tablet consumption', 'analgesic tablet consumption', 'Success', 'age, sex, body mass index, renal parancyhimal thickness, hydronephrosis, skin-to-stone distance, Hounsfield units, and stone size']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0266294', 'cui_str': 'Solitary Functioning Kidney'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C1458140', 'cui_str': 'Tendency to bleed (observable entity)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}]","[{'cui': 'C0441293', 'cui_str': 'JJ-stent (physical object)'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal Shockwave Lithotripsy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}]",152.0,0.0219339,"In stone-free patients, the number of emergency department visits and analgesic tablet consumption was significantly lower in the stented group than in the non-stented group (P<.001 and P<.001, respectively).","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Yazici', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Estambul, Turquía. Electronic address: md.ozguryazici@yahoo.com.tr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kafkasli', 'Affiliation': 'Department of Urology, Kucukyali Delta Hospital, Estambul, Turquía.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Erbin', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Estambul, Turquía.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bilal Hamarat', 'Affiliation': 'Department of Urology, Konya Training and Research Hospital, Iconio, Turquía.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cubuk', 'Affiliation': 'Department of Urology, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Estambul, Turquía.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Sarilar', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Estambul, Turquía.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sarica', 'Affiliation': 'Department of Urology, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Estambul, Turquía.'}]",Actas urologicas espanolas,['10.1016/j.acuro.2019.03.009']
329,32209825,Community Health Workers Reduce Rehospitalizations and Emergency Department Visits for Low-Socioeconomic Urban Patients With Heart Failure.,"BACKGROUND


Low-socioeconomic, urban, minority patients with heart failure (HF) often have unique barriers to care. Community health workers (CHWs) are specially trained laypeople who serve as liaisons between underserved communities and the health system. It is not known whether CHWs improve outcomes in low-socioeconomic, urban, minority patients with HF.
HYPOTHESIS


CHWs reduce rehospitalizations, emergency department (ED) visits, and healthcare costs for low-socioeconomic urban patients with HF.
METHODS


Patients admitted with acute decompensated HF were assigned to receive weekly visits by CHW after discharge. Patients were propensity score matched with controls who received usual care. HF-related rehospitalizations, ED visits, and inpatient costs were compared for 12 months following index admission versus the same period before.
RESULTS


Twenty-eight patients who received weekly visits from a CHW for 12 months after discharge were matched with 28 control patients who did not receive CHWs. Patients who received a CHW had a 75% decrease in HF-related ED visits (0.71 vs. 0.18 visits per patient, P < 0.001), an 89% decrease in HF-related readmissions (0.64 vs. 0.07 admissions per patient, P < 0.005), and a significant decrease in inpatient cost for HF-related visits. In controls receiving usual care, there was no significant change in hospitalizations, ED visits, or costs.
CONCLUSIONS


In conclusion, CHWs are associated with reduced rehospitalizations, ED visits, and inpatient costs in low-socioeconomic, urban, minority patients with HF. CHWs may be a cost-effective method to reduce health care utilization and improve outcomes for this population.",2020,"In controls receiving usual care, there was no significant change in hospitalizations, ED visits, or costs.
","['Community health workers (CHW) are specially trained lay-people who serve as liaisons between underserved communities and the health system', 'Patients were propensity-score matched with controls who received usual care', 'Low-Socioeconomic Urban Patients with Heart Failure', 'minority patients with heart failure (HF', 'low-socioeconomic, urban, minority patients with HF', 'Patients admitted with acute decompensated HF', 'low-socioeconomic urban patients with heart failure (HF', 'Twenty-eight patients who received weekly visits from a CHW for 12 months after discharge were matched with 28 control patients who did not receive CHWs']","['CHWs', 'CHW']","['rehospitalizations, emergency department (ED) visits, and healthcare costs', 'reduced rehospitalizations, ED visits, and inpatient costs', 'HF-related readmissions', 'hospitalizations, ED visits, or costs', 'inpatient cost for HF-related visits', 'HF-related rehospitalizations, ED visits, and inpatient costs', 'HF-related ED visits']","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]",[],"[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",28.0,0.0287021,"In controls receiving usual care, there was no significant change in hospitalizations, ED visits, or costs.
","[{'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Vohra', 'Affiliation': 'From the Department of Medicine, The University of Chicago, Chicago, IL.'}, {'ForeName': 'Rhys F M', 'Initials': 'RFM', 'LastName': 'Chua', 'Affiliation': 'Section of Cardiology, Department of Medicine, The University of Chicago, Chicago, IL, and.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Besser', 'Affiliation': 'Section of Cardiology, Department of Medicine, The University of Chicago, Chicago, IL, and.'}, {'ForeName': 'Charina F', 'Initials': 'CF', 'LastName': 'Alcain', 'Affiliation': 'Section of Cardiology, Department of Medicine, The University of Chicago, Chicago, IL, and.'}, {'ForeName': 'Sweta', 'Initials': 'S', 'LastName': 'Basnet', 'Affiliation': 'Urban Health Initiative, The University of Chicago Medicine, Chicago, IL.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Battle', 'Affiliation': 'Urban Health Initiative, The University of Chicago Medicine, Chicago, IL.'}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Coplan', 'Affiliation': 'Section of Cardiology, Department of Medicine, The University of Chicago, Chicago, IL, and.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Liao', 'Affiliation': 'Section of Cardiology, Department of Medicine, The University of Chicago, Chicago, IL, and.'}, {'ForeName': 'Corey E', 'Initials': 'CE', 'LastName': 'Tabit', 'Affiliation': 'Section of Cardiology, Department of Medicine, The University of Chicago, Chicago, IL, and.'}]",Critical pathways in cardiology,['10.1097/HPC.0000000000000220']
330,32268601,Effects of Brain Breaks Videos on the Motives for the Physical Activity of Malaysians with Type-2 Diabetes Mellitus.,"Brain Breaks videos are web-based structured physical activity (PA) videos that aim at stimulating an interest in learning and promoting health. Exercise is one of the important treatment regimens for people with type 2 diabetes mellitus (T2DM). Thus, the objective of this study was to determine the effects that Brain Breaks videos have on the motives for PA, as measured by the Physical Activity and Leisure Motivation Scale-Malay (PALMS-M), and the amount of PA, as measured by the International Physical Activity Questionnaire-Malay (IPAQ-M), in T2DM patients (the most common type of diabetes mellitus patients). This study was conducted using a randomized, double-blind design and grouped subjects under two research conditions: an experimental group given Brain Breaks videos and a control group. Purposive sampling was employed to recruit 70 T2DM patients (male = 39, female = 31) with the mean age of 57.6 (SD = 8.5) from Hospital Universiti Sains Malaysia, Kelantan. Over a four-month period, the participants in the experimental group were asked to perform PA daily based on a Brain Breaks video (10 min in duration) that was shared through a WhatsApp group. All participants from both groups answered the PALMS-M questionnaire five times: pre-intervention, the end of the first month, second month, and third month, and post-intervention. A repeated measure multivariate analysis of variance and a repeated measure analysis of variance were performed for the analyses of the data. The results demonstrated that four (appearance, others' expectations, physical condition, and mastery) out of eight motives for PA produced a significant mean score difference between the two study groups. All eight motives for PA showed an upward trend for the experimental group during the study period, while the control group showed a downward trend for all motives during the study period. As for the amount of PA, both groups showed significant differences ( p  = 0.001). The amount of PA increased in the experimental group during the study period, while it decreased in the control group. Therefore, Brain Breaks videos can be considered as an effective intervention for motivating T2DM patients for PA and improving their amount of PA.",2020,"As for the amount of PA, both groups showed significant differences ( p  = 0.001).","['70 T2DM patients (male = 39, female = 31) with the mean age of 57.6 (SD = 8.5) from Hospital Universiti Sains Malaysia, Kelantan', 'Malaysians with Type-2 Diabetes Mellitus', 'people with type 2 diabetes mellitus (T2DM']","['Brain Breaks Videos', 'PA daily based on a Brain Breaks video']","['amount of PA', 'Physical Activity and Leisure Motivation Scale-Malay (PALMS-M), and the amount of PA, as measured by the International Physical Activity Questionnaire-Malay (IPAQ-M']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0024549', 'cui_str': 'Malay language'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",70.0,0.0236696,"As for the amount of PA, both groups showed significant differences ( p  = 0.001).","[{'ForeName': 'Aizuddin', 'Initials': 'A', 'LastName': 'Hidrus', 'Affiliation': 'Unit of Biostatistics and Research Methodology, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia.'}, {'ForeName': 'Yee Cheng', 'Initials': 'YC', 'LastName': 'Kueh', 'Affiliation': 'Unit of Biostatistics and Research Methodology, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia.'}, {'ForeName': 'Bachok', 'Initials': 'B', 'LastName': 'Norsaádah', 'Affiliation': 'Unit of Biostatistics and Research Methodology, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia.'}, {'ForeName': 'Yu-Kai', 'Initials': 'YK', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei 24449, Taiwan.'}, {'ForeName': 'Tsung-Min', 'Initials': 'TM', 'LastName': 'Hung', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei 24449, Taiwan.'}, {'ForeName': 'Nyi Nyi', 'Initials': 'NN', 'LastName': 'Naing', 'Affiliation': 'Faculty of Medicine, Universiti Sultan Zainal Abidin, Medical Campus, Jalan Sultan Mahmud, 20400 Kuala Terengganu, Terengganu, Malaysia.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Kuan', 'Affiliation': 'Exercise and Sports Science Programme, School of Health Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia.'}]",International journal of environmental research and public health,['10.3390/ijerph17072507']
331,32404539,Counteracting effect of verbal ratings of sleepiness on dual task interference.,"The aim of the present study was to demonstrate the effect of verbal ratings on arousal in the electroencephalogram (EEG) and psychomotor vigilance test (PVT) performance. Thirty participants underwent the PVT for 40 min in three experimental conditions: (1) Rating condition, in which they verbally rated subjective sleepiness with Karolinska sleepiness scale, following pure tone sound played every 20 s during PVT, (2) No-rating condition, in which they underwent PVT with the similar sound as the Rating experiment but without the verbal rating task, and (3) Control condition, in which they underwent PVT with a no-sound stimulus and without the verbal rating task. The results show that during the first half of the task epoch, alpha power density was lower in the Rating than in the No-rating condition, while performance was not different between the conditions. During the second half of the task epoch, performance was better in the Non-rating than in the Rating condition, but no difference in the alpha power density. These results suggest that performance deterioration could be masked by the arousal effect of the dual task itself. It could also explain why the PVT performance and arousal in EEG sometimes dissociate, particularly in dual task situations.",2020,"During the second half of the task epoch, performance was better in the Non-rating than in the Rating condition, but no difference in the alpha power density.",['Thirty participants underwent the'],"['pure tone sound played every 20 s during PVT, (2) No-rating condition, in which they underwent PVT with the similar sound as the Rating experiment but without the verbal rating task, and (3) Control condition, in which they underwent PVT with a no-sound stimulus and without the verbal rating task', 'PVT']","['alpha power density', 'verbal ratings on arousal in the electroencephalogram (EEG) and psychomotor vigilance test (PVT) performance', 'verbal ratings of sleepiness on dual task interference']","[{'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332288', 'cui_str': 'Without'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}]",30.0,0.0278604,"During the second half of the task epoch, performance was better in the Non-rating than in the Rating condition, but no difference in the alpha power density.","[{'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kaida', 'Affiliation': 'Human Informatics and Interaction Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'International Institute for Integrative Sleep Medicine (WPI-IIIS), Japan.'}, {'ForeName': 'Sunao', 'Initials': 'S', 'LastName': 'Iwaki', 'Affiliation': 'Human Informatics and Interaction Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), Japan.'}]",Industrial health,['10.2486/indhealth.2020-0005']
332,31759333,Single and repeated ketamine infusions for reduction of suicidal ideation in treatment-resistant depression.,"Repeated administration of subanesthetic intravenous ketamine may prolong the rapid decrease in suicidal ideation (SI) elicited by single infusions. The purpose of this secondary analysis was to evaluate reduction in SI with a single ketamine infusion compared with an active control, and prolonged suppression of SI with repeated and maintenance infusions. Thirty-seven participants with treatment-resistant depression (TRD) and baseline SI first received a single ketamine infusion during a randomized, double-blind crossover with midazolam. Following relapse of depressive symptoms, participants received six open-label ketamine infusions administered thrice-weekly over 2 weeks. Antidepressant responders (≥50% decrease in Montgomery-Åsberg Depression Rating Scale [MADRS] scores) received four further open-label infusions administered once-weekly. Changes in SI were assessed with the suicide items on the MADRS (item 10, MADRS-SI) and the Quick Inventory of Depressive Symptomatology-Self Report (item 12, QIDS-SI). Linear mixed models revealed that compared with midazolam, a single ketamine infusion elicited larger reduction in SI (P = 0.01), with maximal effects measured at 7 days postinfusion (P < 0.001, Cohen's d = 0.83). Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94). QIDS-SI results were consistent with MADRS-SI. Overall, 69% of participants had a complete alleviation of SI following repeated infusions. In TRD, single and repeated ketamine infusions resulted in decreases in SI which were maintained with once-weekly maintenance infusions. This study adds to the growing body of research suggesting ketamine as a possible novel treatment strategy for SI in mood disorders.",2020,"Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94).",['Thirty-seven participants with treatment-resistant depression (TRD) and baseline SI first received a single'],"['midazolam', 'six open-label ketamine', 'ketamine', 'subanesthetic intravenous ketamine', 'ketamine infusion', 'ketamine infusions']","['Changes in SI', 'Quick Inventory of Depressive Symptomatology-Self Report', 'cumulative reductions in MADRS-SI scores', 'suicidal ideation (SI', 'SI', 'suicidal ideation', 'Montgomery-Åsberg Depression Rating Scale [MADRS] scores', 'complete alleviation of SI']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",37.0,0.234581,"Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94).","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Phillips', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada. Jennifer.Phillips@theroyal.ca.""}, {'ForeName': 'Sandhaya', 'Initials': 'S', 'LastName': 'Norris', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Talbot', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Hatchard', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Birmingham', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Olabisi', 'Initials': 'O', 'LastName': 'Owoeye', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Batten', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blier', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0570-x']
333,32188593,Hepatic de novo lipogenesis is suppressed and fat oxidation is increased by omega-3 fatty acids at the expense of glucose metabolism.,"OBJECTIVE


Increased hepatic de novo lipogenesis (DNL) is suggested to be an underlying cause in the development of nonalcoholic fatty liver disease and/or insulin resistance. It is suggested that omega-3 fatty acids (FA) lower hepatic DNL. We investigated the effects of omega-3 FA supplementation on hepatic DNL and FA oxidation using a combination of human in vivo and in vitro studies.
RESEARCH DESIGN AND METHODS


Thirty-eight healthy men were randomized to take either an omega-3 supplement (4 g/day eicosapentaenoic acid (EPA)+docosahexaenoic acid (DHA) as ethyl esters) or placebo (4 g/day olive oil) and fasting measurements were made at baseline and 8 weeks. The metabolic effects of omega-3 FAs on intrahepatocellular triacylglycerol (IHTAG) content, hepatic DNL and FA oxidation were investigated using metabolic substrates labeled with stable-isotope tracers. In vitro studies, using a human liver cell-line was undertaken to gain insight into the intrahepatocellular effects of omega-3 FAs.
RESULTS


Fasting plasma TAG concentrations significantly decreased in the omega-3 group and remained unchanged in the placebo group. Eight weeks of omega-3 supplementation significantly decreased IHTAG, fasting and postprandial hepatic DNL while significantly increasing dietary FA oxidation and fasting and postprandial plasma glucose concentrations. In vitro studies supported the in vivo findings of omega-3 FAs (EPA+DHA) decreasing intracellular TAG through a shift in cellular metabolism away from FA esterification toward oxidation.
CONCLUSIONS


Omega-3 supplementation had a potent effect on decreasing hepatic DNL and increasing FA oxidation and plasma glucose concentrations. Attenuation of hepatic DNL may be considered advantageous; however, consideration is required as to what the potential excess of nonlipid substrates (eg, glucose) will have on intrahepatic and extrahepatic metabolic pathways.
TRIAL REGISTRATION NUMBER


NCT01936779.",2020,"Eight weeks of omega-3 supplementation significantly decreased IHTAG, fasting and postprandial hepatic DNL while significantly increasing dietary FA oxidation and fasting and postprandial plasma glucose concentrations.",['Thirty-eight healthy men'],"['Omega-3 supplementation', 'placebo', 'omega-3 FAs', 'omega-3 fatty acids', 'omega-3 FA supplementation', 'omega-3 supplementation', 'omega-3 supplement (4\u2009g/day eicosapentaenoic acid (EPA)+docosahexaenoic acid (DHA) as ethyl esters) or placebo']","['Fasting plasma TAG concentrations', 'dietary FA oxidation and fasting and postprandial plasma glucose concentrations', 'IHTAG, fasting and postprandial hepatic DNL', 'hepatic DNL and increasing FA oxidation and plasma glucose concentrations', 'intrahepatocellular triacylglycerol (IHTAG) content, hepatic DNL and FA oxidation']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",38.0,0.0321803,"Eight weeks of omega-3 supplementation significantly decreased IHTAG, fasting and postprandial hepatic DNL while significantly increasing dietary FA oxidation and fasting and postprandial plasma glucose concentrations.","[{'ForeName': 'Charlotte J', 'Initials': 'CJ', 'LastName': 'Green', 'Affiliation': 'University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Pramfalk', 'Affiliation': 'University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Catriona A', 'Initials': 'CA', 'LastName': 'Charlton', 'Affiliation': 'University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Pippa J', 'Initials': 'PJ', 'LastName': 'Gunn', 'Affiliation': 'University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cornfield', 'Affiliation': 'University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pavlides', 'Affiliation': 'University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Karpe', 'Affiliation': 'University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hodson', 'Affiliation': 'University of Oxford, Oxford, Oxfordshire, UK leanne.hodson@ocdem.ox.ac.uk.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000871']
334,32402609,Feasibility and efficacy of remotely supervised cranial electrical stimulation for pain in older adults with knee osteoarthritis: A randomized controlled pilot study.,"Cranial electrical stimulation (CES) is a noninvasive brain stimulation technique that has been shown to improve pain. However, few studies have investigated the potential benefits associated with remotely supervised CES in older adults with knee osteoarthritis (OA). The aim of this study was to examine the feasibility and preliminary efficacy of remotely supervised CES via secure videoconferencing software on clinical pain severity, experimental pain sensitivity, and pain-related cortical response in older adults with knee OA. Thirty participants with symptomatic knee OA pain were randomly assigned to receive 10 daily sessions (60 min each) of remotely supervised CES (n = 15) or sham CES (n = 15) over two weeks. We measured clinical pain severity via a Numeric Rating Scale, experimental pain sensitivity (e.g., heat pain sensitivity, pressure pain sensitivity, and conditioned pain modulation) using quantitative sensory testing, and pain-related cortical response via functional near-infrared spectroscopy imaging. We also measured participant satisfaction with treatment using the Client Satisfaction Questionnaire. Active CES significantly reduced scores on the Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation. We also found significant changes in pain-related cortical hemodynamic activity after CES. Participants tolerated CES well without serious adverse effects and were satisfied with the treatment. Our findings demonstrate promising clinical efficacy of remotely supervised CES for older adults with knee OA.",2020,"Active CES significantly reduced scores on the Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation.","['older adults with knee osteoarthritis (OA', 'older adults with knee OA', 'older adults with knee osteoarthritis', 'Thirty participants with symptomatic knee OA pain']","['Cranial electrical stimulation (CES', 'Active CES', 'remotely supervised CES (n\xa0=\xa015) or sham CES', 'remotely supervised CES via secure videoconferencing software', 'remotely supervised CES', 'remotely supervised cranial electrical stimulation']","['clinical pain severity, experimental pain sensitivity, and pain-related cortical response', 'pain-related cortical hemodynamic activity', 'Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation', 'clinical pain severity via a Numeric Rating Scale, experimental pain sensitivity (e.g., heat pain sensitivity, pressure pain sensitivity, and conditioned pain modulation) using quantitative sensory testing, and pain-related cortical response via functional near-infrared spectroscopy imaging', 'Participants tolerated CES well without serious adverse effects', 'Feasibility and efficacy']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",30.0,0.10685,"Active CES significantly reduced scores on the Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation.","[{'ForeName': 'Hyochol', 'Initials': 'H', 'LastName': 'Ahn', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA. Electronic address: Hyochol.Ahn@uth.tmc.edu.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Galle', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Mathis', 'Affiliation': 'Department of Orthopedic Surgery, School of Medicine, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Miao', 'Affiliation': 'Department of Biostatistics and Data Science, School of Public Health, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Montero-Hernandez', 'Affiliation': 'Department of Engineering Technology, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Jackson', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Hsiao-Hui', 'Initials': 'HH', 'LastName': 'Ju', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'McCrackin', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Goodwin', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Hargraves', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Bhawna', 'Initials': 'B', 'LastName': 'Jain', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dinh', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Abdul-Mooti', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Pollonini', 'Affiliation': 'Department of Engineering Technology, University of Houston, Houston, TX, USA.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.05.003']
335,31640997,Combining cognitive bias modification training (CBM) and transcranial direct current stimulation (tDCS) to treat binge eating disorder: study protocol of a randomised controlled feasibility trial.,"INTRODUCTION


Binge eating disorder (BED) is a common mental disorder, closely associated with obesity. Existing treatments are only moderately effective with high relapse rates, necessitating novel interventions. This paper describes the rationale for, and protocol of, a feasibility randomised controlled trial (RCT), evaluating the combination of transcranial direct current stimulation (tDCS) and a computerised cognitive training, namely approach bias modification training (ABM), in patients with BED who are overweight or obese. The aim of this trial is to obtain information that will guide decision-making and protocol development in relation to a future large-scale RCT of combined tDCS+ABM treatment in this group of patients, and also to assess the preliminary efficacy of this intervention.
METHODS AND ANALYSIS


66 participants with Diagnostic and Statistical Manual-5 diagnosis of BED and a body mass index (BMI) of ≥25 kg/m 2  will be randomly allocated to one of three groups: ABM+real tDCS; ABM+sham tDCS or a wait-list control group. Participants in both intervention groups will receive six sessions of ABM+real/sham tDCS over 3 weeks; engaging in the ABM task while simultaneously receiving bilateral tDCS to the dorsolateral prefrontal cortex. ABM is based on an implicit learning paradigm in which participants are trained to enact an avoidance behaviour in response to visual food cues. Assessments will be conducted at baseline, post-treatment (3 weeks) and follow-up (7 weeks post-randomisation). Feasibility outcomes assess recruitment and retention rates, acceptability of random allocation, blinding success (allocation concealment), completion of treatment sessions and research assessments. Other outcomes include eating disorder psychopathology and related neurocognitive outcomes (ie, delay of gratification and inhibitory control), BMI, other psychopathology (ie, mood), approach bias towards food and surrogate endpoints (ie, food cue reactivity, trait food craving and food intake).
ETHICS AND DISSEMINATION


This study has been approved by the North West-Liverpool East Research Ethics Committee. Results will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ISRCTN35717198.",2019,Participants in both intervention groups will receive six sessions of ABM+real/sham tDCS over 3 weeks; engaging in the ABM task while simultaneously receiving bilateral tDCS to the dorsolateral prefrontal cortex.,"['patients with BED who are overweight or obese', '66 participants with Diagnostic and Statistical Manual-5 diagnosis of BED and a body mass index (BMI) of ≥25\u2009kg/m 2']","['Combining cognitive bias modification training (CBM) and transcranial direct current stimulation (tDCS', 'transcranial direct current stimulation (tDCS) and a computerised cognitive training, namely approach bias modification training (ABM', 'ABM+real\u2009tDCS; ABM+sham\u2009tDCS or a wait-list control group', 'six sessions of ABM+real/sham tDCS over 3 weeks; engaging in the ABM task while simultaneously receiving bilateral tDCS']","['eating disorder psychopathology and related neurocognitive outcomes (ie, delay of gratification and inhibitory control), BMI, other psychopathology (ie, mood), approach bias towards food and surrogate endpoints (ie, food cue reactivity, trait food craving and food intake', 'retention rates, acceptability of random allocation, blinding success (allocation concealment), completion of treatment sessions and research assessments']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0234057', 'cui_str': 'Gratification (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0162488', 'cui_str': 'Surrogate End Point'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035168'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",66.0,0.206965,Participants in both intervention groups will receive six sessions of ABM+real/sham tDCS over 3 weeks; engaging in the ABM task while simultaneously receiving bilateral tDCS to the dorsolateral prefrontal cortex.,"[{'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Gordon', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK gemma.gordon@kcl.ac.uk.""}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Brockmeyer', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Gottingen, Goettingen, Niedersachsen, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schmidt', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Iain C', 'Initials': 'IC', 'LastName': 'Campbell', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",BMJ open,['10.1136/bmjopen-2019-030023']
336,31641001,"Resilience Against Depression Disparities (RADD): a protocol for a randomised comparative effectiveness trial for depression among predominantly low-income, racial/ethnic, sexual and gender minorities.","INTRODUCTION


Depression is the leading cause of adult disability and common among sexual and gender minority (SGM) adults. The current study builds on findings showing the effectiveness of depression quality improvement (QI) and delivery of cognitive behavioural therapy (CBT) skills provided by community health workers in reducing depression. Depression QI approaches across healthcare and social/community services in safety-net settings have shown improvements in mental wellness, mental health quality of life and depression over 12 months. Further, a randomised study showed improved depression among low-income racial/ethnic minorities enrolled in a CBT-informed resiliency class (Building Resilience and Increasing Community Hope (B-RICH)). The current protocol describes a comparativeness effectiveness study to evaluate whether predominantly low-income, SGM racial/ethnic minority adults randomised to a CBT-informed resiliency class have improvements in depressive symptoms over and above community-engaged QI resources and training only.
METHODS AND ANALYSIS


The study approached three clusters of four to five programs serving predominantly SGM and racial/ethnic minority communities in the USA: two clusters in Los Angeles, California, and one in New Orleans, Louisiana. Clusters are comprised of one primary care, one mental health and two to three community agencies (eg, faith-based, social services/support, advocacy). All programs received depression QI training. The current study employed a community-partnered participatory research model to adapt the CBT-informed resiliency class, B-RICH+, to SGM communities. Study participants were screened and recruited in person from participating programs, and will complete baseline, 6- and 12-month survey follow-ups. Participants were depressed adults (8-item Patient Health Questionnaire ≥10; ≥18 years of age) who provided contact information. Enrolled participants were individually randomised to B-RICH+ or depression QI alone. Primary outcomes are depressive symptoms; secondary outcomes are mental health quality of life, mental wellness and physical health quality of life. Data collection for this study is ongoing.
ETHICS AND DISSEMINATION


The current study was approved by the UCLA Institutional Review Board. Study findings will be disseminated through scientific publications and community conferences.
TRIAL REGISTRATION NUMBER


https://clinicaltrials.gov/ct2/show/NCT02986126.",2019,"Depression QI approaches across healthcare and social/community services in safety-net settings have shown improvements in mental wellness, mental health quality of life and depression over 12 months.","['depression among predominantly low-income, racial/ethnic, sexual and gender minorities', 'three clusters of four to five programs serving predominantly SGM and racial/ethnic minority communities in the USA: two clusters in Los Angeles, California, and one in New Orleans, Louisiana', 'Study participants were screened and recruited in person from participating programs, and will complete baseline, 6- and 12-month survey follow-ups', 'community health workers in reducing depression', 'Participants were depressed adults (8-item Patient Health Questionnaire ≥10; ≥18 years of age) who provided contact information']","['cognitive behavioural therapy (CBT) skills', 'CBT-informed resiliency class', 'RICH+ or depression QI alone', 'depression QI training']","['depressive symptoms', 'Resilience Against Depression Disparities', 'depressive symptoms; secondary outcomes are mental health quality of life, mental wellness and physical health quality of life', 'mental wellness, mental health quality of life and depression']","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C4277573', 'cui_str': 'Sexual and Gender Minorities'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4521841', 'cui_str': 'MGySgt'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0024024', 'cui_str': 'Louisiana'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.158018,"Depression QI approaches across healthcare and social/community services in safety-net settings have shown improvements in mental wellness, mental health quality of life and depression over 12 months.","[{'ForeName': 'Sylvanna Maria', 'Initials': 'SM', 'LastName': 'Vargas', 'Affiliation': 'Psychology, University of Southern California, Los Angeles, California, USA sylvannv@usc.edu.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Wennerstrom', 'Affiliation': 'School of Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Alfaro', 'Affiliation': 'Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Belin', 'Affiliation': 'Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Krystal', 'Initials': 'K', 'LastName': 'Griffith', 'Affiliation': 'Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Haywood', 'Affiliation': 'Tulane Prevention Research Center, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Felica', 'Initials': 'F', 'LastName': 'Jones', 'Affiliation': 'Healthy African American Families II, Los Angeles, California, USA.'}, {'ForeName': 'Mitchell R', 'Initials': 'MR', 'LastName': 'Lunn', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Meyers', 'Affiliation': ""Saint Anna's Episcopal Church, New Orleans, Louisiana, USA.""}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Miranda', 'Affiliation': 'Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Juno', 'Initials': 'J', 'LastName': 'Obedin-Maliver', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Pollock', 'Affiliation': 'Section of Community and Population Medicine, Department of Medicine, Louisiana State University School of Medicine, New Orleans, Louisiana, USA.'}, {'ForeName': 'Cathy D', 'Initials': 'CD', 'LastName': 'Sherbourne', 'Affiliation': 'RAND Corporation, Los Angeles, California, USA.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Springgate', 'Affiliation': 'Section of Community and Population Medicine, Department of Medicine, Louisiana State University School of Medicine, New Orleans, Louisiana, USA.'}, {'ForeName': 'Olivia K', 'Initials': 'OK', 'LastName': 'Sugarman', 'Affiliation': 'Section of Community and Population Medicine, Department of Medicine, Louisiana State University School of Medicine, New Orleans, Louisiana, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Rey', 'Affiliation': 'LGBT Community Center, New Orleans, Louisiana, USA.'}, {'ForeName': 'Clarence', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Healthy African American Families II, Los Angeles, California, USA.'}, {'ForeName': 'Pluscedia', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'Healthy African American Families II, Los Angeles, California, USA.'}, {'ForeName': 'Bowen', 'Initials': 'B', 'LastName': 'Chung', 'Affiliation': 'Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, UCLA, Los Angeles, California, USA.'}]",BMJ open,['10.1136/bmjopen-2019-031099']
337,31791039,Mechanistic link between right prefrontal cortical activity and anxious arousal revealed using transcranial magnetic stimulation in healthy subjects.,"Much of the mechanistic research on anxiety focuses on subcortical structures such as the amygdala; however, less is known about the distributed cortical circuit that also contributes to anxiety expression. One way to learn about this circuit is to probe candidate regions using transcranial magnetic stimulation (TMS). In this study, we tested the involvement of the dorsolateral prefrontal cortex (dlPFC), in anxiety expression using 10 Hz repetitive TMS (rTMS). In a within-subject, crossover experiment, the study measured anxiety in healthy subjects before and after a session of 10 Hz rTMS to the right dorsolateral prefrontal cortex (dlPFC). It used threat of predictable and unpredictable shock to induce anxiety and anxiety potentiated startle to assess anxiety. Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS. These results suggest a mechanistic link between right dlPFC activity and physiological anxiety expression. This result supports current models of prefrontal asymmetry in affect, and lays the groundwork for further exploration into the cortical mechanisms mediating anxiety, which may lead to novel anxiety treatments.",2020,"Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS.","['healthy subjects before and after a session of 10\u2009Hz rTMS to the right dorsolateral prefrontal cortex (dlPFC', 'healthy subjects']","['10\u2009Hz repetitive TMS (rTMS', 'transcranial magnetic stimulation', 'transcranial magnetic stimulation (TMS']",['anxiety-potentiated startle'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0546911', 'cui_str': 'To the right (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0106782,"Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS.","[{'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Balderston', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. nicholas.balderston@pennmedicine.upenn.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Beydler', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Zhi-De', 'Initials': 'ZD', 'LastName': 'Deng', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Radman', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Lago', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Luber', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grillon', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0583-5']
338,32192467,"Efficacy of zinc sulfate on indirect hyperbilirubinemia in premature infants admitted to neonatal intensive care unit: a double-blind, randomized clinical trial.","BACKGROUND


Hyperbilirubinemia is a common neonatal problem. Studies conducted on the effectiveness of zinc salts on serum indirect bilirubin levels in newborns have yielded different results, all calling for further research. This study aimed to determine the effect of oral zinc sulfate on indirect hyperbilirubinemia in preterm infants admitted to the neonatal intensive care unit.
METHODS


A randomized double-blind clinical trial was performed in the neonatal intensive care unit of Vali-e-Asr Hospital in Birjand, Iran. The study population comprised neonates aged between 31 and 36 gestational weeks, who required phototherapy in the neonatal intensive care unit. A total of 60 neonates were selected by census and allocated into an experimental group and a control group. In addition to phototherapy, the experimental group received 1 cc/Kg zinc sulfate syrup (containing 5 mg/5 cc zinc sulfate; Merck Company, Germany), and the control group received a placebo syrup (containing 1 cc/kg sucrose). Data were analyzed in SPSS-21 software using the independent t-test, repeated-measures ANOVA, Bonferroni post-hoc test, and Mann-Whitney test. P-values smaller than 0.05 were considered significant.
RESULTS


Bilirubin level changes in the experimental and control groups six hours after intervention were - 1.45 ± 3.23 and - 0.49 ± 0.37 (p = 0.024), respectively. The changes 24 and 48 h after intervention were-3.26 ± 2.78 and - 1.89 ± 1.20 (p = 0.017) in the experimental group and - 4.89 ± 2.76 and - 3.98 ± 2.32 (p = 0.23) in the control group, respectively. There was no significant difference in the phototherapy duration between the two groups (p = 0.24).
CONCLUSIONS


The results of this study showed that the use of zinc sulfate syrup in preterm infants with indirect hyperbilirubinemia significantly reduced bilirubin levels within 48 h of treatment.
TRIAL REGISTRATION


Trial registration: IRCT, IRCT2015120825439N1. Registered 21 February 2016, http://irct.ir/trial/21277.",2020,"There was no significant difference in the phototherapy duration between the two groups (p = 0.24).
","['preterm infants admitted to the neonatal intensive care unit', 'neonatal intensive care unit of Vali-e-Asr Hospital in Birjand, Iran', 'neonates aged between 31 and 36 gestational weeks, who required phototherapy in the neonatal intensive care unit', 'preterm infants with indirect hyperbilirubinemia', 'newborns', 'premature infants admitted to neonatal intensive care unit', '60 neonates']","['placebo syrup', 'zinc sulfate', '1\u2009cc/Kg zinc sulfate syrup', 'oral zinc sulfate', 'zinc sulfate syrup', 'zinc salts']","['phototherapy duration', 'bilirubin levels', 'Bilirubin level changes', 'indirect hyperbilirubinemia', 'serum indirect bilirubin levels']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C0268306', 'cui_str': 'Unconjugated hyperbilirubinemia (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0458173', 'cui_str': 'Syrup (substance)'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0351669', 'cui_str': 'Zinc salt (substance)'}]","[{'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0268306', 'cui_str': 'Unconjugated hyperbilirubinemia (disorder)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0301719', 'cui_str': 'Indirect reacting bilirubin (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",60.0,0.479153,"There was no significant difference in the phototherapy duration between the two groups (p = 0.24).
","[{'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Faal', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Birjand University of Medical Sciences, South Khorasan Province, Birjand, Iran. faalgh1@bums.ac.ir.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Khatib Masjedi', 'Affiliation': 'Faculty of Medicine, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Sharifzadeh', 'Affiliation': 'Faculty of Health, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Kiani', 'Affiliation': 'Faculty of Pharmacy, Birjand University of Medical Sciences, Birjand, Iran.'}]",BMC pediatrics,['10.1186/s12887-020-02025-9']
339,32404287,Cardiopulmonary exercise testing and aerobic treadmill training after stroke: Feasibility of a controlled trial.,"PURPOSE


To investigate the feasibility and safety of a randomized controlled trial that performed cardiopulmonary exercise testing and 12 weeks of aerobic treadmill training in individuals in the chronic phase after stroke.
METHODS


The following data were recorded: number of individuals contacted to participate, that attended in the evaluation session, and that were included (recruited) in the study; retention, attendance and adherence rates; reasons for exclusion, withdrawal, non-attendance and non-completing exercise; adverse events.
RESULTS


From 230 individuals that were contacted, 39 (17%) attended the evaluation session and 22 (9.6%) were recruited in the study, 11 in each group (control and experimental). The main source of recruitment was other research projects (43.5%). The main reason for exclusion was unavailability (22%). Six out of 39 individuals (15.4%) that attended in the evaluation session were not able to perform the cardiopulmonary exercise testing. All subjects included showed a respiratory exchange ratio ≥1.0 (considered as maximal effort in the CPET). Retention rate was 81% and the main reason of withdrawal was unavailability (75%). The overall attendance rate was 88% and the main reason for non-attendance was illness/sickness (20.8%). The adherence rate was 99% and the reasons for non-completing sessions were illness/sickness (60%) or delay (40%). No serious adverse events occurred.
CONCLUSION


Recruitment rate was low, retention rate was moderate, attendance and adherence rates were high. No serious adverse events occurred. It was feasible and safe to execute a randomized clinical trial that performed cardiopulmonary exercise testing and 12 weeks of aerobic treadmill training.",2020,"No serious adverse events occurred.
","['From 230 individuals that were contacted, 39 (17%) attended the evaluation session and 22 (9.6%) were recruited in the study, 11 in each group (control and experimental', 'individuals contacted to participate, that attended in the evaluation session, and that were included (recruited) in the study; retention, attendance and adherence rates; reasons for exclusion, withdrawal, non-attendance and non-completing exercise; adverse events', 'individuals in the chronic phase after stroke']","['cardiopulmonary exercise testing and 12 weeks of aerobic treadmill training', 'Cardiopulmonary exercise testing and aerobic treadmill training']","['adherence rate', 'overall attendance rate', 'retention rate was moderate, attendance and adherence rates', 'Retention rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.106437,"No serious adverse events occurred.
","[{'ForeName': 'Sherindan Ayessa Ferreira De', 'Initials': 'SAF', 'LastName': 'Brito', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Av. Antônio Carlos, 6627, Campus Pampulha, CEP: 31270-910, Belo Horizonte, Brazil. Electronic address: sherindanayessa@hotmail.com.'}, {'ForeName': 'Larissa Tavares', 'Initials': 'LT', 'LastName': 'Aguiar', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Av. Antônio Carlos, 6627, Campus Pampulha, CEP: 31270-910, Belo Horizonte, Brazil. Electronic address: larissatavaresaguiar@gmail.com.'}, {'ForeName': 'Laura Nolasco', 'Initials': 'LN', 'LastName': 'Garcia', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Av. Antônio Carlos, 6627, Campus Pampulha, CEP: 31270-910, Belo Horizonte, Brazil. Electronic address: lauranolasco15@hotmail.com.'}, {'ForeName': 'Paula Da Cruz', 'Initials': 'PDC', 'LastName': 'Peniche', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Av. Antônio Carlos, 6627, Campus Pampulha, CEP: 31270-910, Belo Horizonte, Brazil. Electronic address: penichepaula@yahoo.com.br.'}, {'ForeName': 'Maria Teresa Ferreira Dos', 'Initials': 'MTFD', 'LastName': 'Reis', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Av. Antônio Carlos, 6627, Campus Pampulha, CEP: 31270-910, Belo Horizonte, Brazil. Electronic address: mariateresafdr@gmail.com.'}, {'ForeName': 'Christina Danielli Coelho De Morais', 'Initials': 'CDCM', 'LastName': 'Faria', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Av. Antônio Carlos, 6627, Campus Pampulha, CEP: 31270-910, Belo Horizonte, Brazil. Electronic address: cdcmf@ufmg.br.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104854']
340,32401589,Re: Randomised Clinical Trial of Prostate Artery Embolisation versus a Sham Procedure for Benign Prostatic Hyperplasia.,,2020,,['Benign Prostatic Hyperplasia'],['Prostate Artery Embolisation'],[],"[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}]",[],,0.264533,,"[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001100']
341,32164314,High-Intensity Interval Circuit Training Versus Moderate-Intensity Continuous Training on Cardiorespiratory Fitness in Middle-Aged and Older Women: A Randomized Controlled Trial.,"High-intensity interval training (HIIT) has similar or better effects than moderate-intensity continuous training (MICT) in increasing peak oxygen consumption (VO 2max ), however, it has not been studied when HIIT is applied in a circuit (HIICT). The aim of this study was to compare the effects of a HIICT versus MICT on VO 2max  estimated (VO 2max -ES), heart rate (HR) and blood pressure (BP) of middle-aged and older women. A quasi-experimental randomized controlled trial was used. Fifty-four women (67.8 ± 6.2 years) were randomized to either HIICT ( n  = 18), MICT ( n  = 18) or non-exercise control group (CG;  n  = 18) for 18 weeks. Participants in HIICT and MICT trained two days/week (one hour/session). Forty-one participants were assessed (HIICT;  n  = 17, MICT;  n  = 12, CG;  n  = 12). Five adverse events were reported. Cardiorespiratory fitness, HR and BP were measured. The tests were performed before and after the exercise intervention programs. VO 2max -ES showed significant training x group interaction, in which HIICT and MICT were statistically superior to CG. Moreover, HIICT and MICT were statistically better than CG in the diastolic blood pressure after exercise (DBP ex ) interaction. For the systolic blood pressure after exercise (SBP ex ), HIICT was statistically better than CG. In conclusion, both HIICT and MICT generated adaptations in VO 2max -ES and DBP ex . Furthermore, only HIICT generated positive effects on the SBP ex . Therefore, both training methods can be considered for use in exercise programs involving middle-aged and older women.",2020,"Moreover, HIICT and MICT were statistically better than CG in the diastolic blood pressure after exercise (DBP ex ) interaction.","['middle-aged and older women', 'Fifty-four women (67.8 ± 6.2 years', 'Middle-Aged and Older Women', 'Forty-one participants were assessed (HIICT;  n  = 17, MICT;  n  = 12, CG;  n  = 12']","['HIICT versus MICT', 'High-intensity interval training (HIIT', 'CG', 'moderate-intensity continuous training (MICT', 'HIICT and MICT', 'MICT ( n  = 18) or non-exercise control', 'HIICT', 'High-Intensity Interval Circuit Training Versus Moderate-Intensity Continuous Training']","['Cardiorespiratory fitness, HR and BP', 'Cardiorespiratory Fitness', 'systolic blood pressure', 'VO 2max  estimated (VO 2max -ES), heart rate (HR) and blood pressure (BP', 'diastolic blood pressure']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",54.0,0.0559491,"Moreover, HIICT and MICT were statistically better than CG in the diastolic blood pressure after exercise (DBP ex ) interaction.","[{'ForeName': 'Ismael', 'Initials': 'I', 'LastName': 'Ballesta-García', 'Affiliation': 'Physical Exercise and Human Performance Research Group, University of Murcia, 30003 Murcia, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Martínez-González-Moro', 'Affiliation': 'Physical Exercise and Human Performance Research Group, University of Murcia, 30003 Murcia, Spain.'}, {'ForeName': 'Domingo J', 'Initials': 'DJ', 'LastName': 'Ramos-Campo', 'Affiliation': 'Department of Physical Activity and Sport Sciences, UCAM Research Centre for High Performance Sport, Catholic University of San Antonio de Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Carrasco-Poyatos', 'Affiliation': 'Department of Education, Health and Public Administration Research Center, University of Almeria, 04120 Almeria, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17051805']
342,31676658,Behavioural activation in nursing homes to treat depression (BAN-Dep): study protocol for a pragmatic randomised controlled trial.,"INTRODUCTION


Depression is a common disorder among older people living in residential aged care facilities. Several trials have demonstrated the effectiveness of behavioural therapies in treating depressive symptoms in older adults living in the community and in residential aged care. Behavioural Activation is demonstrably effective even when delivered by non-specialists (staff without formal psychological training), although strategies for adapting its use in residential aged care facilities are yet to be explored. This study will determine whether training residential care staff in the use of a structured Behavioural Activation programme is more effective at decreasing depressive symptoms among older residents than internet-based training about depression recognition and management alone.
METHOD AND ANALYSIS


The behavioural activation in nursing homes to treat depression (BAN-Dep) trial is a pragmatic two-arm parallel clustered randomised controlled trial. It will recruit 666 residents aged 60 or older from 100 residential aged care facilities, which will be randomly assigned to the Behavioural Activation or control intervention. Staff in both treatment groups will be encouraged to complete the  Beyondblue  Professional Education to Aged Care e-learning programme to improve their recognition of and ability to respond to depression in older adults. Selected staff from intervention facilities will undergo additional training to deliver an 8-module Behavioural Activation programme to residents with subthreshold symptoms of depression-they will receive ongoing Mental support from trained Behavioural Activation therapists. Outcome measures will be collected by blind research officer at baseline and after 3, 6 and 12 months. The Patient Health Questionnaire-9 is the primary outcome measure of the study.
ETHICS AND DISSEMINATION


The trial will comply with the principles of the Declaration of Helsinki for Human Rights and is overseen by the University of Western Australia (reference RA/4/20/4234) and Melbourne Health (reference number HREC/18/MH/47) Ethics Committees. The results of this research project will be disseminated through publications and/or presentations in a variety of media to health professionals, academics, clinicians and the public. Only de-identified group data will be presented.
TRIAL REGISTRATION


ACTRN12618000634279.",2019,"This study will determine whether training residential care staff in the use of a structured Behavioural Activation programme is more effective at decreasing depressive symptoms among older residents than internet-based training about depression recognition and management alone.
","['older residents', 'older adults', '666 residents aged 60 or older from 100 residential aged care facilities', 'older adults living in the community and in residential aged care', 'nursing homes to treat depression', 'older people living in residential aged care facilities', 'nursing homes to treat depression (BAN-Dep', 'residential aged care facilities']","['Behavioural Activation or control intervention', 'structured Behavioural Activation programme', 'behavioural therapies']",['Behavioural activation'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0105185', 'cui_str': 'BANS'}, {'cui': 'C0057472', 'cui_str': '1-(2-(dodecyloxy)ethyl)pyrrolidine hydrochloride'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}]",[],666.0,0.181829,"This study will determine whether training residential care staff in the use of a structured Behavioural Activation programme is more effective at decreasing depressive symptoms among older residents than internet-based training about depression recognition and management alone.
","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Velasquez Reyes', 'Affiliation': 'Psychiatry, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Hema', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'Medical School, University of Western Australia Faculty of Medicine Dentistry and Health Sciences, Perth, Western Australia, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lautenschlager', 'Affiliation': 'Psychiatry, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ford', 'Affiliation': 'Medical School, University of Western Australia Faculty of Medicine Dentistry and Health Sciences, Perth, Western Australia, Australia.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Curran', 'Affiliation': 'Psychiatry, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Kelly', 'Affiliation': 'Medical School, University of Western Australia Faculty of Medicine Dentistry and Health Sciences, Perth, Western Australia, Australia.'}, {'ForeName': 'Rhoda', 'Initials': 'R', 'LastName': 'Lai', 'Affiliation': 'Psychiatry, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Chong', 'Affiliation': 'Psychiatry, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Flicker', 'Affiliation': 'Medical School, University of Western Australia Faculty of Medicine Dentistry and Health Sciences, Perth, Western Australia, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ekers', 'Affiliation': 'Psychiatry, University of York, York, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Psychiatry, University of York, York, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Etherton-Beer', 'Affiliation': 'Medical School, University of Western Australia Faculty of Medicine Dentistry and Health Sciences, Perth, Western Australia, Australia.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Lo Giudice', 'Affiliation': 'Aged Care, Melbourne Health, Parkville, Victoria, Australia.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Ellis', 'Affiliation': 'Psychiatry, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Angelita', 'Initials': 'A', 'LastName': 'Martini', 'Affiliation': 'Brightwater Care Group, Osborne Park, Western Australia, Australia.'}, {'ForeName': 'Osvaldo P', 'Initials': 'OP', 'LastName': 'Almeida', 'Affiliation': 'Medical School, University of Western Australia Faculty of Medicine Dentistry and Health Sciences, Perth, Western Australia, Australia osvaldo.almeida@uwa.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-032421']
343,31676660,"Protocol for a pilot randomised controlled trial evaluating feasibility and acceptability of cognitive remediation group therapy compared with mutual aid group therapy for people ageing with HIV-associated neurocognitive disorder (HAND) in Toronto, Canada.","INTRODUCTION


HIV-associated neurocognitive disorder (HAND) may affect 30%-50% of people ageing with HIV. HAND may increase stress and anxiety, and impede coping. Psychosocial group therapy may ameliorate HAND's symptoms, yet the ideal intervention is unclear. This protocol outlines a pilot randomised controlled trial (RCT)-designed using community-based participatory research-to pilot cognitive remediation group therapy (CRGT) against an active comparator.
METHODS AND ANALYSIS


This is a pilot, parallel design, two-arm RCT that will recruit participants diagnosed with the mild neurocognitive disorder form of HAND from a neurobehavioural research unit at a tertiary care hospital in Toronto, Canada. Eligibility criteria include age ≥40 years, known HIV status for 5+ years, English fluency, able to consent and able to attend 8 weeks of group therapy. Eligible participants will be randomised to one of two treatment arms, each consisting of eight-session group interventions delivered once weekly at 3 hours per session. Arm 1 (novel) is CRGT, combining mindfulness-based stress reduction with brain training activities. Arm 2 (active control) is mutual aid group therapy. The primary outcomes are feasibility, measured by proportions of recruitment and completion, and acceptability, determined by a satisfaction questionnaire. The secondary outcome is intervention fidelity, where content analysis will be used to assess facilitator session reports. A between-group analysis will be conducted on exploratory outcomes of stress, anxiety, coping and use of intervention activities that will be collected at three time points.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the Research Ethics Boards of St. Michael's Hospital and the University of Toronto. Findings will be disseminated through peer-reviewed publications, conference presentations and community reporting. This study could provide insight into design (eg, recruitment, measures) and intervention considerations (eg, structure, content) for a larger trial to lessen the burden of cognitive decline among people ageing with HIV.
TRIAL REGISTRATION NUMBER


NCT03483740; Pre-results.",2019,"Eligible participants will be randomised to one of two treatment arms, each consisting of eight-session group interventions delivered once weekly at 3 hours per session.","['participants diagnosed with the mild neurocognitive disorder form of HAND from a neurobehavioural research unit at a tertiary care hospital in Toronto, Canada', 'people ageing with HIV', 'Eligible participants', 'people ageing with HIV-associated neurocognitive disorder (HAND) in Toronto, Canada', 'Eligibility criteria include age ≥40 years, known HIV status for 5+ years, English fluency, able to consent and able to attend 8\u2009weeks of group therapy']","['mutual aid group therapy', 'pilot cognitive remediation group therapy (CRGT', 'cognitive remediation group therapy', 'Psychosocial group therapy']","['feasibility, measured by proportions of recruitment and completion, and acceptability, determined by a satisfaction questionnaire', 'stress and anxiety']","[{'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0426867', 'cui_str': 'Form of hand (observable entity)'}, {'cui': 'C0035168'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive Disorders'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}]","[{'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.18219,"Eligible participants will be randomised to one of two treatment arms, each consisting of eight-session group interventions delivered once weekly at 3 hours per session.","[{'ForeName': 'Andrew David', 'Initials': 'AD', 'LastName': 'Eaton', 'Affiliation': 'Factor-Inwentash Faculty of Social Work, University of Toronto, Toronto, Ontario, Canada andrew.eaton@utoronto.ca.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Walmsley', 'Affiliation': 'Toronto General Research Institute, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Shelley L', 'Initials': 'SL', 'LastName': 'Craig', 'Affiliation': 'Factor-Inwentash Faculty of Social Work, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sean B', 'Initials': 'SB', 'LastName': 'Rourke', 'Affiliation': ""Centre for Urban Health Solutions, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Sota', 'Affiliation': ""Centre for Urban Health Solutions, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'McCullagh', 'Affiliation': 'Ontario AIDS Network (OAN), Toronto, Ontario, Canada.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Fallon', 'Affiliation': 'Factor-Inwentash Faculty of Social Work, University of Toronto, Toronto, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2019-033183']
344,32402832,Transrectal Natural Orifice Specimen Extraction (NOSE) With Oncological Safety: A Prospective and Randomized Trial.,"BACKGROUND


In the present paper, we introduce our experience with the novel method during laparoscopic anterior resection of upper rectal or sigmoid colon cancer by transrectal natural orifice specimen extraction (NOSE).
METHODS


A prospective randomized controlled trial was performed from June 2016 to May 2019. Patients with upper rectal or sigmoid colon cancer were randomized in a 1:1 ratio to the NOSE group and the non-NOSE group. Preoperative and postoperative clinical variables were analyzed and compared between groups. Postoperative pain was analyzed utilizing a visual analog scale. Postoperative overall survival was analyzed using a Kaplan-Meier curve.
RESULTS


A total of 276 patients were enrolled, of whom 254 were randomly divided into the NOSE group (n = 122) and the conventional laparoscopic group (n = 119). NOSE failed in 22 cases, which were converted to transabdominal specimen extraction. Intention-to-treat analysis was performed, and these 22 cases were included in the NOSE group. The incidence of postoperative complications was significantly lower in the NOSE group (11/122, 9%) than in the non-NOSE group (25/119, 21%). The NOSE group had a longer operation time, less blood loss, and a lower postoperative visual analog scale score than the non-NOSE group. The time for intestinal function recovery (ventilation) and the length of hospital stay were significantly longer in the non-NOSE group. The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
CONCLUSIONS


The novel NOSE method is safe and feasible to use in patients having colorectal cancer. Compared with traditional laparoscopic surgery, the postoperative complication rates of NOSE surgery were lower with an improved short-term clinical recovery.",2020,"The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
","['June 2016 to May 2019', 'patients having colorectal cancer', '22 cases were included in the NOSE group', 'Patients with upper rectal or sigmoid colon cancer', 'A total of 276 patients were enrolled, of whom 254']","['conventional laparoscopic group', 'traditional laparoscopic surgery', 'laparoscopic anterior resection of upper rectal or sigmoid colon cancer by transrectal natural orifice specimen extraction (NOSE', 'Transrectal Natural Orifice Specimen Extraction (NOSE', 'NOSE']","['incidence of postoperative complications', 'longer operation time, less blood loss', 'postoperative complication rates of NOSE surgery', 'time for intestinal function recovery (ventilation) and the length of hospital stay', 'disease-free survival rate', 'postoperative visual analog scale score', 'Postoperative overall survival', 'Postoperative pain']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",276.0,0.0637219,"The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
","[{'ForeName': 'Zhu-Qing', 'Initials': 'ZQ', 'LastName': 'Zhou', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Kaijing', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Du', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qixin', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chuan-Gang', 'Initials': 'CG', 'LastName': 'Fu', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: fugang416@126.com.'}]",The Journal of surgical research,['10.1016/j.jss.2020.03.064']
345,32074302,Whole-Body Vibration Training Increases Stem/Progenitor Cell Circulation Levels and May Attenuate Inflammation.,"INTRODUCTION


Whole-body vibration training (WBVT) may benefit individuals with difficulty participating in physical exercise. The objective was to explore the effects of WBVT on circulating stem/progenitor cell (CPC) and cytokine levels.
METHODS


Healthy male subjects each performed three activities randomly on separate days: (1) standing platform vibration, (2) repetitive leg squat exercise; and (3) in combination. Pre- and post-activity blood samples were drawn. Cell populations were characterized using flow cytometry. Biomarkers were analyzed using enzyme-linked immunosorbent assays.
RESULTS


CPC levels increased significantly 21% with exercise alone (1465 ± 202-1770 ± 221 cells/mL; P = 0.017) and 33% with vibration alone in younger participants (1918 ± 341-2559 ± 496; P = 0.02). Angiogenic CPCs increased 39% during combined activity in younger (633 ± 128-882 ± 181; P = 0.05). Non-angiogenic CPCs increased 42% with vibration alone in younger (1181 ± 222-1677 ± 342; P = 0.04), but 32% with exercise alone in older participants (801 ± 251-1053 ± 325; P = 0.05). With vibration alone, anti-inflammatory cytokine interleukin-10 increased significantly (P < 0.03), although inflammatory interleukin-6 decreased (P = 0.056); tumor necrosis factor-alpha (P < 0.01) and vascular endothelial growth factor levels increased (P < 0.005), which are synergistically pro-angiogenic.
CONCLUSIONS


WBVT may have positive vascular and anti-inflammatory effects. WBVT could augment or serve as an exercise surrogate in warfighters and others who cannot fully participate in exercise programs, having important implications in military health.",2020,"With vibration alone, anti-inflammatory cytokine interleukin-10 increased significantly (P < 0.03), although inflammatory interleukin-6 decreased (P = 0.056); tumor necrosis factor-alpha (P < 0.01) and vascular endothelial growth factor levels increased (P < 0.005), which are synergistically pro-angiogenic.
CONCLUSIONS


WBVT may have positive vascular and anti-inflammatory effects.","['individuals with difficulty participating in physical exercise', 'Healthy male subjects']","['WBVT', 'standing platform vibration, (2) repetitive leg squat exercise; and (3) in combination', 'Whole-Body Vibration Training', 'Whole-body vibration training (WBVT']","['anti-inflammatory cytokine interleukin-10', 'Angiogenic CPCs', 'Non-angiogenic CPCs', 'CPC levels', 'inflammatory interleukin-6', 'circulating stem/progenitor cell (CPC) and cytokine levels', 'vascular endothelial growth factor levels']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}]",,0.0221865,"With vibration alone, anti-inflammatory cytokine interleukin-10 increased significantly (P < 0.03), although inflammatory interleukin-6 decreased (P = 0.056); tumor necrosis factor-alpha (P < 0.01) and vascular endothelial growth factor levels increased (P < 0.005), which are synergistically pro-angiogenic.
CONCLUSIONS


WBVT may have positive vascular and anti-inflammatory effects.","[{'ForeName': 'Yameena', 'Initials': 'Y', 'LastName': 'Jawed', 'Affiliation': 'Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, School of Medicine, Indiana University, 541 Clinical Dr., CL 260, Indianapolis, IN 46202.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Beli', 'Affiliation': 'Indiana Diabetes Research Center, School of Medicine, Indiana University, 635 Barnhill Dr., MS 2031A, Indianapolis, IN 46202.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'March', 'Affiliation': 'Center for Regenerative Medicine, College of Medicine, University of Florida, M-108 Health Science Center, P.O. Box 100216, Gainesville, FL 32610.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Kaleth', 'Affiliation': 'Department of Kinesiology, School of Health and Human Sciences, Indiana University, 901 W. New York Street, Indianapolis, IN 46202.'}, {'ForeName': 'M Terry', 'Initials': 'MT', 'LastName': 'Loghmani', 'Affiliation': 'Department of Physical Therapy, School of Health and Human Sciences, Indiana University, 1140 W. Michigan Street, CF320A, Indianapolis, IN 46202.'}]",Military medicine,['10.1093/milmed/usz247']
346,31660826,Pharmacokinetics-based Dose Management of 5-Fluorouracil Clinical Research in Advanced Colorectal Cancer Treatment.,"OBJECTIVE


The study aimed to explore the efficacy of pharmacokinetic-based 5-fluorouracil dose management by plasma concentration test in advanced colorectal cancer treatment.
METHODS


153 samples of advanced colorectal cancer patients were enrolled and randomly assigned to a control group and an experimental group. All patients received double-week chemotherapy with 5- fluorouracil (four weeks were used as one period), and chemotherapy duration ranged from 2 to 6 periods. In the first period, all patients were administered with the classic strategy of body surface area (BSA).
RESULTS


In the subsequent periods, the control group (77 samples) continued with BSA guided chemotherapy, while the experimental group (76 samples) received pharmacokinetic AUC-based chemotherapy. The efficacy and toxic side effects were assessed during chemotherapy, and survival was recorded in a follow-up. In the AUC experimental group, the rate of diarrhea significantly decreased (37.50% vs. 70.00%, P=0.010), and incidence of oral mucositis reduced (54.17% vs. 82.50%, P=0.014). Compared with the control group, the clinical benefit rate of experimental group was much higher (90.79% vs. 79.22%, P=0.046).
CONCLUSION


There was no significant difference in other 5-fluorouracil related toxic side effect events (nausea, vomiting, hand-foot syndrome) and progression-free survival between the two groups. Pharmacokinetic- based dose management of 5-Fluorouracil reduces the toxicity of chemotherapy and improves long-term efficacy of chemotherapy for advanced colorectal cancer patients.",2020,Pharmacokinetics-based dose management of 5-Fluorouracil reduces toxicity of chemotherapy and improved long-term efficacy of chemotherapy for advanced colorectal cancer patients.,"['Advanced Colorectal Cancer Treatment', '153 samples of advanced colorectal cancer patients', 'advanced colorectal cancer treatment', 'advanced colorectal cancer patients']","['pharmacokinetics-based 5-fluorouracil', 'chemotherapy', 'pharmacokinetics AUC-based chemotherapy', '5-Fluorouracil', 'BSA guided chemotherapy', '5-Fluorouracil Clinical Research', 'double-week chemotherapy with 5-fluorouracil']","['Clinical benefit rate', 'Efficacy and toxic side effects', '5-fluorouracil related toxic side effect events (nausea, vomiting, hand-foot syndrome) and progression free survival', 'oral mucositis', 'rate of diarrhea']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0852711', 'cui_str': 'Hand-foot syndrome in sickle cell anemia (disorder)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.0342248,Pharmacokinetics-based dose management of 5-Fluorouracil reduces toxicity of chemotherapy and improved long-term efficacy of chemotherapy for advanced colorectal cancer patients.,"[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Deng', 'Affiliation': 'Department of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, 42 Baiziting, Nanjing, Jiangsu 210009, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, 42 Baiziting, Nanjing, Jiangsu 210009, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'School of Medicine, Jiangsu University, Zhenjiang, Jiangsu 212000, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, Jiangsu University, Zhenjiang, Jiangsu 212000, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': 'Department of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, 42 Baiziting, Nanjing, Jiangsu 210009, China.'}, {'ForeName': 'DeLiang', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, 42 Baiziting, Nanjing, Jiangsu 210009, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Shen', 'Affiliation': 'Department of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, 42 Baiziting, Nanjing, Jiangsu 210009, China.'}]",Mini reviews in medicinal chemistry,['10.2174/1389557519666191011154923']
347,32200533,Discrepancy Between Fasting Flow-Mediated Dilation and Parameter of Lipids in Blood: A Randomized Exploratory Study of the Effect of Omega-3 Fatty Acid Ethyl Esters on Vascular Endothelial Function in Patients With Hyperlipidemia.,"INTRODUCTION


Omega-3 fatty acid ethyl esters (omega-3), an eicosapentaenoic acid and docosahexaenoic acid preparation (Lotriga ® , Takeda Pharmaceutical Company Limited), are approved in Japan to treat triglyceridemia. We investigated the effects of omega-3 on vascular endothelial function, measured by flow-mediated dilation (FMD).
METHODS


Patients with dyslipidemia receiving 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors were randomized 1:1 to receive omega-3 at 2 g (QD) or 4 g (2 g BID) for 8 weeks. The primary end point was the change from baseline of fasting  %FMD in each treatment group. Secondary end points included the 4-h postprandial  %FMD and 4-h postprandial triglyceride (TG) level.
RESULTS


Thirty-seven patients were randomized to receive omega-3 at 2 g (n = 18) or 4 g (n = 19). Mean fasting %FMD did not increase from baseline to week 8 in the 2-g group (- 1.2%) or 4-g group (- 1.3%). Mean 4-h postprandial %FMD did not change from baseline to week 8 in the 2-g group (0.0%), but increased in the 4-g group (1.0%). Mean 4-h postprandial TG level decreased by 34.7 mg/dl from baseline over week 8 in the 2-g group, with a significantly larger decrease in the 4-g group of 75.9 mg/dl (p < 0.001). No new safety concerns were identified.
CONCLUSIONS


Fasting %FMD did not improve after 8 weeks of omega-3 treatment at 2 g or 4 g. After 8 weeks, 4-h postprandial TG levels showed improvement at both doses, with a greater reduction in the 4-g group.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT02824432.",2020,"Mean 4-h postprandial TG level decreased by 34.7 mg/dl from baseline over week 8 in the 2-g group, with a significantly larger decrease in the 4-g group of 75.9 mg/dl (p < 0.001).","['Patients With Hyperlipidemia', 'Thirty-seven patients', 'Patients with dyslipidemia receiving 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors']","['Omega-3 Fatty Acid Ethyl Esters', 'Omega-3 fatty acid ethyl esters (omega-3), an eicosapentaenoic acid and docosahexaenoic acid preparation', 'omega-3 at 2\xa0g']","['Mean 4-h postprandial TG level', '4-h postprandial \xa0%FMD and 4-h postprandial triglyceride (TG) level', 'Vascular Endothelial Function', 'Mean 4-h postprandial %FMD', 'change from baseline of fasting \xa0%FMD', 'Discrepancy Between Fasting Flow-Mediated Dilation and Parameter of Lipids in Blood', '4-h postprandial TG levels', 'Mean fasting %FMD', 'vascular endothelial function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0061511', 'cui_str': 'glutaryl-coenzyme A'}, {'cui': 'C0047420', 'cui_str': 'S-(hydrogen 3-hydroxy-3-methylpentanedioate) coenzyme A'}, {'cui': 'C0030016', 'cui_str': 'Reductases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005768'}]",37.0,0.0642346,"Mean 4-h postprandial TG level decreased by 34.7 mg/dl from baseline over week 8 in the 2-g group, with a significantly larger decrease in the 4-g group of 75.9 mg/dl (p < 0.001).","[{'ForeName': 'Tamio', 'Initials': 'T', 'LastName': 'Teramoto', 'Affiliation': 'Teikyo Academic Research Center, Teikyo University, Tokyo, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Shibata', 'Affiliation': 'Faculty of Medicine, Oita University, Oita, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Suzaki', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Tokyo, Japan. yuki.suzaki@takeda.com.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Matsui', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Tokyo, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Uemura', 'Affiliation': 'Faculty of Medicine, Oita University, Oita, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yamashina', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}]",Advances in therapy,['10.1007/s12325-020-01286-1']
348,32074365,Understanding How Clinicians Use a New Web-based Tool for Disseminating Evidence-Based Practices for the Treatment of PTSD: The PTSD Clinicians Exchange.,"INTRODUCTION


Web-based interventions hold great promise for the dissemination of best practices to clinicians, and investment in these resources has grown exponentially. Yet, little research exists to understand their impact on intended objectives.
MATERIALS & METHODS


The Post-Traumatic Stress Disorder (PTSD) Clinicians Exchange is a website to support clinicians treating veterans and active duty military personnel with PTSD, evaluated in a randomized controlled trial (N = 605). This manuscript explores how a subset of clinicians, those who utilized the intervention (N = 148), engaged with it by examining detailed individual-level web analytics and qualitative feedback. Stanford University and New England Research Institutes Institutional Review Boards approved this study.
RESULTS


Only 32.7% of clinicians randomized to the intervention ever accessed the website. The number of pages viewed was positively associated with changes from baseline to 12 months in familiarity (P = 0.03) and perceived benefit of practices (P = 0.02). Thus, engagement with the website did predict an improvement in practice familiarity and benefit outcomes despite low rates of use.
CONCLUSIONS


This study demonstrates the importance of methodologically rigorous evaluations of participant engagement with web-based interventions. These approaches provide insight into who accesses these tools, when, how, and with what results, which can be translated into their strategic design, evaluation, and dissemination.",2020,The number of pages viewed was positively associated with changes from baseline to 12 months in familiarity (P = 0.03) and perceived benefit of practices (P = 0.02).,['clinicians treating veterans and active duty military personnel with PTSD'],[],"['number of pages viewed', 'practice familiarity']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}]",,0.0584791,The number of pages viewed was positively associated with changes from baseline to 12 months in familiarity (P = 0.03) and perceived benefit of practices (P = 0.02).,"[{'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Coleman', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Marceau', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Zincavage', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Magnavita', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ambrosoli', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Simon', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, 795 Willow Road, Menlo Park, CA 94025.'}, {'ForeName': 'Kile', 'Initials': 'K', 'LastName': 'Ortigo', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, 795 Willow Road, Menlo Park, CA 94025.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Clarke-Walper', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD 20910.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Penix', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD 20910.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Wilk', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD 20910.'}, {'ForeName': 'Josef I', 'Initials': 'JI', 'LastName': 'Ruzek', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, 795 Willow Road, Menlo Park, CA 94025.'}, {'ForeName': 'Raymond C', 'Initials': 'RC', 'LastName': 'Rosen', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}]",Military medicine,['10.1093/milmed/usz313']
349,31862764,"Effects of suboptimal adherence of CPAP therapy on symptoms of obstructive sleep apnoea: a randomised, double-blind, controlled trial.","INTRODUCTION


Continuous positive airway pressure (CPAP) is currently the treatment of choice for sleepiness in patients with obstructive sleep apnoea (OSA); however, adherence is often thought to be suboptimal. We investigated the effects of suboptimal CPAP usage on objective and subjective sleepiness parameters in patients with OSA.
MATERIAL AND METHODS


In this 2-week, parallel, double-blind, randomised controlled trial we enrolled moderate-to-severe OSA patients with excessive pre-treatment daytime sleepiness (Epworth sleepiness scale (ESS) score >10 points) who had suboptimal CPAP adherence over ≥12 months (mean nightly usage time 3-4 h). Patients were allocated through minimisation to either subtherapeutic CPAP (""sham CPAP"") or continuation of CPAP (""therapeutic CPAP""). A Bayesian analysis with historical priors calculated the posterior probability of superiority.
RESULTS


Between May, 2016 and November, 2018, 57 patients (aged 60±8 years, 79% male, 93% Caucasian) were allocated in total, and 52 who completed the study (50% in each arm) were included in the final analysis. The unadjusted ESS score increase was 2.4 points (95% CI 0.6-4.2, p=0.01) in the sham-CPAP group when compared to continuing therapeutic CPAP. The probability of superiority of therapeutic CPAP over sham CPAP was 90.4% for ESS, 90.1% for systolic blood pressure and 80.3% for diastolic blood pressure.
CONCLUSIONS


Patients with moderate-to-severe OSA and daytime sleepiness are still getting a substantial benefit from suboptimal CPAP adherence, albeit not as much as they might get if they adhered more. Whether a similar statement can be made for even lower adherence levels remains to be established in future trials.",2020,"The probability of superiority of therapeutic CPAP over sham CPAP was 90.4% for ESS, 90.1% for systolic, and 80.3% for diastolic blood pressure.
","['patients with OSA', 'enrolled moderate-to-severe OSA patients with excessive pre-treatment daytime sleepiness (Epworth-Sleepiness-Scale [ESS] score >10 points) who had suboptimal CPAP adherence over at least 12\u2005months (mean nightly usage time 3-4\u2005h', 'Between May, 2016 and November, 2018, 57 patients (60±8\u2005years, 79% men, 93% Caucasian) were allocated in total, and 52 who completed the study (50% in each arm) were included in the final analysis', 'patients with obstructive sleep apnea (OSA']","['subtherapeutic CPAP (""sham-CPAP"") or continuation of CPAP (therapeutic-CPAP', 'CPAP-therapy', 'suboptimal CPAP-usage', 'Continuous positive airway pressure (CPAP']","['diastolic blood pressure', 'unadjusted ESS-score increase', 'objective and subjective sleepiness parameters', 'symptoms of obstructive sleep apnea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C4706348', 'cui_str': 'Epworth Sleepiness Scale score (observable entity)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}]","[{'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]",57.0,0.436515,"The probability of superiority of therapeutic CPAP over sham CPAP was 90.4% for ESS, 90.1% for systolic, and 80.3% for diastolic blood pressure.
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gaisl', 'Affiliation': 'Dept of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Protazy', 'Initials': 'P', 'LastName': 'Rejmer', 'Affiliation': 'Dept of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sira', 'Initials': 'S', 'LastName': 'Thiel', 'Affiliation': 'Dept of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Haile', 'Affiliation': 'Epidemiology, Biostatistics, and Prevention Institute, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Osswald', 'Affiliation': 'Dept of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Roos', 'Affiliation': 'Epidemiology, Biostatistics, and Prevention Institute, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Konrad E', 'Initials': 'KE', 'LastName': 'Bloch', 'Affiliation': 'Dept of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Stradling', 'Affiliation': 'National Institute for Health Research (NIHR), Oxford Biomedical Research Centre based at Oxford University Hospitals NHS Foundation Trust and University of Oxford, Oxford, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Kohler', 'Affiliation': 'Dept of Pulmonology, University Hospital Zurich, Zurich, Switzerland malcolm.kohler@usz.ch.'}]",The European respiratory journal,['10.1183/13993003.01526-2019']
350,32205449,"Primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) for FIGO stage III epithelial ovarian cancer: OVHIPEC-2, a phase III randomized clinical trial.","BACKGROUND


The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery. The effect of HIPEC remains undetermined in patients who are candidates for primary cytoreductive surgery.
PRIMARY OBJECTIVE


The primary objective is to evaluate the effect of HIPEC on overall survival in patients with FIGO stage III epithelial ovarian cancer who are treated with primary cytoreductive surgery resulting in no residual disease, or residual disease up to 2.5 mm in maximum dimension.
STUDY HYPOTHESIS


We hypothesize that the addition of HIPEC to primary cytoreductive surgery improves overall survival in patients with primary FIGO stage III epithelial ovarian cancer.
TRIAL DESIGN


This international, randomized, open-label, phase III trial will enroll 538 patients with newly diagnosed FIGO stage III epithelial ovarian cancer. Following complete or near-complete (residual disease ≤2.5 mm) primary cytoreduction, patients are randomly allocated (1:1) to receive HIPEC or no HIPEC. All patients will receive six courses of platinum-paclitaxel chemotherapy, and maintenance PARP-inhibitor or bevacizumab according to current guidelines.
MAJOR ELIGIBILITY CRITERIA


Patients with FIGO stage III primary epithelial ovarian, fallopian tube, or primary peritoneal cancer are eligible after complete or near-complete primary cytoreductive surgery. Patients with resectable umbilical, spleen, or local bowel lesions may be included. Enlarged extra-abdominal lymph nodes should be negative on FDG-PET or fine-needle aspiration/biopsy.
PRIMARY ENDPOINT


The primary endpoint is overall survival.
SAMPLE SIZE


To detect a HR of 0.67 in favor of HIPEC, 200 overall survival events are required. With an expected accrual period of 60 months and 12 months additional follow-up, 538 patients need to be randomized.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS


The OVHIPEC-2 trial started in January 2020 and primary analyses are anticipated in 2026.
TRIAL REGISTRATION


ClinicalTrials.gov:NCT03772028.",2020,"BACKGROUND


The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery.","['patients with FIGO stage III epithelial ovarian cancer who are treated with primary cytoreductive surgery resulting in no residual disease, or residual disease up to 2.5\u2009mm in maximum dimension', 'Patients with resectable umbilical, spleen, or local bowel lesions', 'FIGO stage III epithelial ovarian cancer', '538 patients with newly diagnosed FIGO stage III epithelial ovarian cancer', 'Patients with FIGO stage III primary epithelial ovarian, fallopian tube, or primary peritoneal cancer are eligible after complete or near-complete primary cytoreductive surgery', 'patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery', '538 patients need to be randomized', 'patients who are candidates for primary cytoreductive surgery', 'patients with primary FIGO stage III epithelial ovarian cancer']","['Primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC', 'platinum-paclitaxel chemotherapy, and maintenance PARP-inhibitor or bevacizumab', 'hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery', 'HIPEC', 'HIPEC or no HIPEC']","['recurrence-free and overall survival', 'overall survival', 'overall survival events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0037993', 'cui_str': 'Spleen'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum (disorder)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1882413', 'cui_str': 'PARP Inhibitors'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",538.0,0.335434,"BACKGROUND


The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery.","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Koole', 'Affiliation': 'Department of Gynaecology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'van Stein', 'Affiliation': 'Department of Gynaecology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Sikorska', 'Affiliation': 'Department of Biostatistics, Netherlands Cancer Institute, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Barton', 'Affiliation': 'Department of Gynaecological Oncology, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Perrin', 'Affiliation': 'Queensland Centre for Gynaecological Cancer, Herston, Queensland, Australia.'}, {'ForeName': 'Donal', 'Initials': 'D', 'LastName': 'Brennan', 'Affiliation': 'Gynaecology Oncology, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zivanovic', 'Affiliation': 'Department of Gynecologic Oncology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Berit Jul', 'Initials': 'BJ', 'LastName': 'Mosgaard', 'Affiliation': 'Department of Gynaecology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fagotti', 'Affiliation': 'Dipartimento Scienze della Salute della Donna e del Bambino, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Pierre-Emmanuel', 'Initials': 'PE', 'LastName': 'Colombo', 'Affiliation': 'Department of Surgical Oncology, Institut régional du Cancer de Montpellier, Montpellier, France.'}, {'ForeName': 'Gabe', 'Initials': 'G', 'LastName': 'Sonke', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'W J van', 'Initials': 'WJV', 'LastName': 'Driel', 'Affiliation': 'Department of Gynaecology, Netherlands Cancer Institute, Amsterdam, The Netherlands w.v.driel@nki.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001231']
351,31597650,"Attachment-based compassion therapy and adapted mindfulness-based stress reduction for the treatment of depressive, anxious and adjustment disorders in mental health settings: a randomised controlled clinical trial protocol.","INTRODUCTION


Depressive, anxiety and adjustment disorders are highly prevalent among mental health outpatients. The lack of funding for mental health problems produces inefficient results and a high burden of disease. New cost-effective group interventions aimed at treating these symptoms might be an appropriate solution to reduce the healthcare burden in mental health units. Mindfulness-based interventions (MBIs) have shown significant reductions in anxious, depressive and adjustment symptomatology. Recent research highlights the influence of compassion as a key mechanism of change. However, MBIs only address compassion implicitly, whereas compassion-based protocols consider it a core aspect of psychotherapy. In this randomised controlled trial, we hypothesise that the provision of attachment-based compassion therapy (ABCT), which is a compassion-based protocol, will be more effective than mindfulness-based stress reduction (MBSR), which is a conventional MBI programme, for the treatment of depressive, anxious and adaptive symptoms in patients in mental health settings.
METHODS AND ANALYSIS


Approximately 90 patients suffering from depressive, anxious or adjustment disorders recruited from Spanish mental health settings will be randomised to receive 8 weekly 2 hours group sessions of ABCT, 8 weekly 2.5 hours group sessions of adapted MBSR (with no full-day silent retreat) or treatment as usual (TAU), with a 1:1:1 allocation rate. Patients in the ABCT and adapted MBSR groups will also receive TAU. The main outcome will be general affective distress measured by means of the 'Depression Anxiety Stress Scales-21' at post-test as primary endpoint. Other outcomes will be quality of life, mindfulness, self-compassion and the use of healthcare services. There will be a 6-month follow-up assessment. Intention-to-treat analysis will be conducted using linear mixed models. Per-protocol and secondary outcome analyses will be performed. A data monitoring committee comprising the trial manager, the ABCT and MBSR teachers and an independent clinical psychologist will monitor for possible negative side effects.
ETHICS AND DISSEMINATION


Approval was obtained from the Ethics Committee of the General University Hospital of Castellón, Spain. The results will be submitted to peer-reviewed specialised journals, and brief reports will be sent to participants on request.
TRIAL REGISTRATION NUMBER


NCT03425487.",2019,"Mindfulness-based interventions (MBIs) have shown significant reductions in anxious, depressive and adjustment symptomatology.","['mental health outpatients', 'Approximately 90 patients suffering from depressive, anxious or adjustment disorders recruited from Spanish mental health settings', 'patients in mental health settings', 'depressive, anxious and adjustment disorders in mental health settings']","['ABCT, 8 weekly 2.5\u2009hours group sessions of adapted MBSR (with no full-day silent retreat) or treatment as usual (TAU', 'Mindfulness-based interventions (MBIs', 'attachment-based compassion therapy (ABCT', 'Attachment-based compassion therapy and adapted mindfulness-based stress reduction']","['anxious, depressive and adjustment symptomatology', ""general affective distress measured by means of the 'Depression Anxiety Stress Scales-21"", 'Depressive, anxiety and adjustment disorders', 'quality of life, mindfulness, self-compassion and the use of healthcare services']","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001546', 'cui_str': 'Reactive Disorders'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0443304', 'cui_str': 'Silent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C0001546', 'cui_str': 'Reactive Disorders'}, {'cui': 'C0034380'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0557829', 'cui_str': 'Healthcare services (qualifier value)'}]",,0.169331,"Mindfulness-based interventions (MBIs) have shown significant reductions in anxious, depressive and adjustment symptomatology.","[{'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Montero-Marin', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Collado-Navarro', 'Affiliation': 'La Plana University Hospital, Castellón, Spain.'}, {'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Navarro-Gil', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain maytenavarrogil@gmail.com.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Lopez-Montoyo', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Demarzo', 'Affiliation': 'Department of Preventive Medicine, Mente Aberta - Brazilian Center for Mindfulness and Health Promotion, Universidade Federal de São Paulo, UNIFESP, São Paulo, Brazil.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Herrera-Mercadal', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Barcelo-Soler', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Garcia-Campayo', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain.'}]",BMJ open,['10.1136/bmjopen-2019-029909']
352,31548678,Brain regulation of emotional conflict predicts antidepressant treatment response for depression.,"The efficacy of antidepressant treatment for depression is controversial due to the only modest superiority demonstrated over placebo. However, neurobiological heterogeneity within depression may limit overall antidepressant efficacy. We sought to identify a neurobiological phenotype responsive to antidepressant treatment by testing pretreatment brain activation during response to, and regulation of, emotional conflict as a moderator of the clinical benefit of the antidepressant sertraline versus placebo. Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes. Treatment-predictive machine learning using brain metrics outperformed a model trained on clinical and demographic variables. Our findings demonstrate that antidepressant response is predicted by brain activity underlying a key self-regulatory emotional capacity. Leveraging brain-based measures in psychiatry will forge a path toward better treatment personalization, refined mechanistic insights and improved outcomes.",2019,"Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes.",[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0530251,"Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes.","[{'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry, Dell Medical School, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. amitetkin@stanford.edu.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Cherise', 'Initials': 'C', 'LastName': 'Chin-Fatt', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Trombello', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Myrna M', 'Initials': 'MM', 'LastName': 'Weissman', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]",Nature human behaviour,['10.1038/s41562-019-0732-1']
353,32202333,"Correlations among pain, depressive symptoms, constipation, and serotonin levels in smokers and non smokers.","PURPOSE


To examine the differences and correlations among pain, depressive symptoms, and constipation in smokers and non smokers.
DESIGN AND METHODS


The present study was a cross-sectional study that used descriptive correlations. This study was a secondary analysis of a randomized clinical trial.
FINDINGS


Smokers had more pain, depressive symptoms, and constipation than non smokers. Smokers had similar serotonin levels compared with non smokers. Positive correlations were observed between constipation and serum serotonin levels (r = .19, P = .039, n = 116), between constipation and depressive symptoms (r = .18, P = .023, n = 164), and between constipation and pain (r = .23, P = .004, n = 164) in smokers.
PRACTICAL IMPLICATIONS


Health professionals should assess and treat patients with the knowledge that the severity of pain, depression, and constipation may be greater in smokers than in non smokers.",2020,Smokers had similar serotonin levels compared with non smokers.,['smokers and non smokers'],[],"['pain, depressive symptoms, constipation, and serotonin levels', 'serotonin levels', 'constipation and pain', 'constipation and serum serotonin levels', 'constipation and depressive symptoms', 'pain, depressive symptoms, and constipation']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2209695', 'cui_str': 'Serum serotonin'}]",,0.0230196,Smokers had similar serotonin levels compared with non smokers.,"[{'ForeName': 'Eun Jin', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Inha University, Incheon, Republic of Korea.'}]",Perspectives in psychiatric care,['10.1111/ppc.12503']
354,32164522,Four-year follow-up of a randomized controlled trial of choline for neurodevelopment in fetal alcohol spectrum disorder.,"BACKGROUND


Despite the high prevalence of fetal alcohol spectrum disorder (FASD), there are few interventions targeting its core neurocognitive and behavioral deficits. FASD is often conceptualized as static and permanent, but interventions that capitalize on brain plasticity and critical developmental windows are emerging. We present a long-term follow-up study evaluating the neurodevelopmental effects of choline supplementation in children with FASD 4 years after an initial efficacy trial.
METHODS


The initial study was a randomized, double-blind, placebo-controlled trial of choline vs. placebo in 2-5-year-olds with FASD. Participants include 31 children (16 placebo; 15 choline) seen 4 years after trial completion. The mean age at follow-up was 8.6 years. Diagnoses were 12.9% fetal alcohol syndrome (FAS), 41.9% partial FAS, and 45.1% alcohol-related neurodevelopmental disorder. The follow-up included measures of intelligence, memory, executive functioning, and behavior.
RESULTS


Children who received choline had higher non-verbal intelligence, higher visual-spatial skill, higher working memory ability, better verbal memory, and fewer behavioral symptoms of attention deficit hyperactivity disorder than the placebo group. No differences were seen for verbal intelligence, visual memory, or other executive functions.
CONCLUSIONS


These data support choline as a potential neurodevelopmental intervention for FASD and highlight the need for long-term follow-up to capture treatment effects on neurodevelopmental trajectories.
TRIAL REGISTRATION


ClinicalTrials.Gov #NCT01149538; Registered: June 23, 2010; first enrollment July 2, 2010.",2020,"RESULTS


Children who received choline had higher non-verbal intelligence, higher visual-spatial skill, higher working memory ability, better verbal memory, and fewer behavioral symptoms of attention deficit hyperactivity disorder than the placebo group.","['Participants include 31 children (16 placebo; 15 choline) seen 4\xa0years after trial completion', 'children with FASD 4\xa0years after an initial efficacy trial', '2-5-year-olds with FASD', 'fetal alcohol spectrum disorder']","['placebo', 'FASD', 'choline supplementation', 'choline vs. placebo', 'choline']","['verbal intelligence, visual memory, or other executive functions', 'intelligence, memory, executive functioning, and behavior', 'non-verbal intelligence, higher visual-spatial skill, higher working memory ability, better verbal memory, and fewer behavioral symptoms of attention deficit hyperactivity disorder']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2985290', 'cui_str': 'FASD'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2985290', 'cui_str': 'FASD'}, {'cui': 'C0556089', 'cui_str': 'Choline supplementation (product)'}, {'cui': 'C0008405', 'cui_str': 'Choline'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0542316', 'cui_str': 'Visual memory (observable entity)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]",31.0,0.594646,"RESULTS


Children who received choline had higher non-verbal intelligence, higher visual-spatial skill, higher working memory ability, better verbal memory, and fewer behavioral symptoms of attention deficit hyperactivity disorder than the placebo group.","[{'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Wozniak', 'Affiliation': 'University of Minnesota Twin Cities, Minneapolis, MN, USA. jwozniak@umn.edu.'}, {'ForeName': 'Birgit A', 'Initials': 'BA', 'LastName': 'Fink', 'Affiliation': 'University of Minnesota Twin Cities, Minneapolis, MN, USA.'}, {'ForeName': 'Anita J', 'Initials': 'AJ', 'LastName': 'Fuglestad', 'Affiliation': 'University of North Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Judith K', 'Initials': 'JK', 'LastName': 'Eckerle', 'Affiliation': 'University of Minnesota Twin Cities, Minneapolis, MN, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Boys', 'Affiliation': 'University of Minnesota Twin Cities, Minneapolis, MN, USA.'}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'Sandness', 'Affiliation': 'University of Minnesota Twin Cities, Minneapolis, MN, USA.'}, {'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Radke', 'Affiliation': 'Fagron Inc., St. Paul, MN, USA.'}, {'ForeName': 'Neely C', 'Initials': 'NC', 'LastName': 'Miller', 'Affiliation': 'University of Minnesota Twin Cities, Minneapolis, MN, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lindgren', 'Affiliation': 'University of Minnesota Twin Cities, Minneapolis, MN, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Brearley', 'Affiliation': 'University of Minnesota Twin Cities, Minneapolis, MN, USA.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Zeisel', 'Affiliation': 'University of North Carolina, Nutrition Research Institute, Kannapolis, NC, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Georgieff', 'Affiliation': 'University of Minnesota Twin Cities, Minneapolis, MN, USA.'}]",Journal of neurodevelopmental disorders,['10.1186/s11689-020-09312-7']
355,32184382,Heel lift improves walking ability of persons with traumatic cauda equina syndrome-a pilot experimental study.,"STUDY DESIGN


Non-randomized within-subject experimental study.
OBJECTIVE


To determine whether the addition of the 1 cm heel lift to the footwear improves the walking ability of the persons with Cauda Equina Syndrome (CES).
SETTING


Department of Physical Medicine and Rehabilitation, Christian Medical College, India.
METHODS


Fourteen people with bilateral plantar flexor weakness following traumatic CES (mean age 43.7 years) were recruited for the study. Their walking speed, stride length, cadence, and time taken to complete Timed Up and Go (TUG) were measured using footwear with back straps. Then, the 1 cm heel lift was attached to the sole of the footwear. After sufficient practice, all the parameters were reassessed to find out the effectiveness of the heel lift.
RESULTS


With the 1 cm heel lift, the participants walked 0.13 m/s (95% CI, 0.08-0.17) faster than their regular footwear. They were able to complete the TUG test 2.6 s (95% CI, 1.4-3.7) earlier than before. There was an increase of 5.2 in. in stride length (95% CI, 2.9-9) and an eight steps increase in cadence (95% CI, 4.9-11.3) observed after the heel lift.
CONCLUSIONS


This pilot study has demonstrated that addition of 1 cm heel may be effective in improving the walking performance of persons with Cauda Equina Syndrome. Future studies should investigate the kinetic and kinematic changes of this modification using a randomized controlled trial study design.",2020,"With the 1 cm heel lift, the participants walked 0.13 m/s (95% CI, 0.08-0.17) faster than their regular footwear.","['Fourteen people with bilateral plantar flexor weakness following traumatic CES (mean age 43.7 years', 'persons with Cauda Equina Syndrome', 'persons with Cauda Equina Syndrome (CES', 'persons with traumatic cauda equina syndrome', 'Department of Physical Medicine and Rehabilitation, Christian Medical College, India']",['Heel lift'],"['walking performance', 'stride length', 'cadence', 'walking speed, stride length, cadence, and time taken to complete Timed Up and Go (TUG', 'walking ability']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C3714552', 'cui_str': 'Weakness - general'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0392548', 'cui_str': 'Cauda Equina Syndrome'}, {'cui': 'C0031813', 'cui_str': 'Physiatrics'}, {'cui': 'C0344346', 'cui_str': 'Christian, follower of religion (person)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0181620', 'cui_str': 'Lift'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}]",14.0,0.0657296,"With the 1 cm heel lift, the participants walked 0.13 m/s (95% CI, 0.08-0.17) faster than their regular footwear.","[{'ForeName': 'Akhil John', 'Initials': 'AJ', 'LastName': 'Kurien', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Thangavelu', 'Initials': 'T', 'LastName': 'Senthilvelkumar', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Christian Medical College, Vellore, Tamil Nadu, India. sentheel@gmail.com.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Vanjeeth', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Rebekah', 'Affiliation': 'Department of Biostatistics, Christian Medical College, Vellore, Tamil Nadu, India.'}]",Spinal cord series and cases,['10.1038/s41394-020-0266-9']
356,32193624,Use of a Discharge Educational Strategy Versus Standard Discharge Care on Reduction of Vascular Risk in Patients with Stroke and Transient Ischemic Attack.,"PURPOSE OF THE REVIEW


The burden of ischemic stroke is disproportionally distributed between ethnic and racial subgroups in the USA, minority populations with lower socioeconomic status being at higher risk. These discrepancies are mirrored in susceptibility, primary care, and post-discharge procedures. Post-discharge strategies are of particular importance as their primary goal is to prevent recurrent stroke, which makes up about 25% of stroke cases per year in US. As disadvantaged minorities have faster growing populations, recurrent stroke poses a significant challenge not only for caretakers but also for the health care system as the whole. A number of educational strategies were employed to inform the general public of major symptoms, risk factors, and preventive measures for recurrent stroke. However, over affected subgroups did not prove responsive to such measures as these did not conform to their cultural and sociological specificities.
RECENT FINDINGS


The Discharge Educational Strategies for Reduction of Vascular Events Intervention (DESERVE) is a randomized control trial with a one year follow up, set out to investigate the possibility that culturally tailored, community-centered post-discharge strategies would improve compliance to therapy and prevention against secondary stroke. The trial targeted African Americans, Hispanic, and non-Hispanic whites, adapting discharge strategies for each individual group. DESERVE accomplished a significant reduction in blood pressure in the Hispanic intervention group by 9.9 mm Hg compared with usual care. The remaining two groups were not susceptible to these measures. DESERVE holds promise for culturally tailored interventions in the future in a battle against stroke and other chronic diseases.",2020,The remaining two groups were not susceptible to these measures.,"['Patients with Stroke and Transient Ischemic Attack', 'African Americans, Hispanic, and non-Hispanic whites, adapting discharge strategies for each individual group']",['Discharge Educational Strategy Versus Standard Discharge Care'],"['blood pressure', 'burden of ischemic stroke', 'Vascular Risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0205169,The remaining two groups were not susceptible to these measures.,"[{'ForeName': 'Anantha R', 'Initials': 'AR', 'LastName': 'Vellipuram', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA. anantha-ramana.vellipuram@ttuhsc.edu.'}, {'ForeName': 'Zain', 'Initials': 'Z', 'LastName': 'Hussain', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}, {'ForeName': 'Prashanth', 'Initials': 'P', 'LastName': 'Rawla', 'Affiliation': 'Department of Internal Medicine/Hospitalist, Sovah Health, Martinsville, VA, 24112, USA.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Maud', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Cruz-Flores', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Khatri', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}]",Current cardiology reports,['10.1007/s11886-020-01283-4']
357,31585971,Can a smartphone-delivered tool facilitate the assessment of surgical site infection and result in earlier treatment? Tracking wound infection with smartphone technology (TWIST): protocol for a randomised controlled trial in emergency surgery patients.,"INTRODUCTION


National data suggest that surgical site infection (SSI) complicates 2%-10% of general surgery cases, although the patient-reported incidence is much higher. SSIs cause significant patient morbidity and represent a significant burden on acute healthcare services, in a cohort predominantly suitable for outpatient management. Over three-quarters of UK adults now own smartphones, which could be harnessed to improve access to care. We aim to investigate if a smartphone-delivered wound assessment tool results in earlier treatment.
METHODS AND ANALYSIS


This is a randomised controlled trial aiming to recruit 500 patients across National Health Service (NHS) hospitals. All emergency abdominal surgery patients over the age of 16 who own smartphones will be considered eligible, with the exclusion of those with significant visual impairment. Participants will be randomised in a 1:1 ratio between standard postoperative care and the intervention - use of the smartphone tool in addition to standard postoperative care. The main outcome measure will be time-to-diagnosis of SSI with secondary outcome measures considering use of emergency department and general practitioner services and patient experience. Follow-up will be conducted by clinicians blinded to group allocation. Analysis of time-to-diagnosis will be by comparison of means using an independent two sample t-test.
ETHICS AND DISSEMINATION


This is the first randomised controlled trial on the use of a smartphone-delivered wound assessment tool to facilitate the assessment of SSI and the impact on time-to-diagnosis. The intervention is being used in addition to standard postoperative care. The study design and protocol were reviewed and approved by Southeast Scotland Research and Ethics Committee (REC Ref: 16/SS/0072 24/05/2016). Study findings will be presented at academic conferences, published in peer-reviewed journals and are expected in 2020. A written lay summary will be available to study participants on request.
TRIAL REGISTRATION NUMBER


NCT02704897; Pre-results.",2019,"Over three-quarters of UK adults now own smartphones, which could be harnessed to improve access to care.","['500 patients across National Health Service (NHS) hospitals', 'emergency surgery patients', 'All emergency abdominal surgery patients over the age of 16 who own smartphones will be considered eligible, with the exclusion of those with significant visual impairment']","['smartphone tool in addition to standard postoperative care', 'smartphone technology (TWIST', 'smartphone-delivered wound assessment tool', 'smartphone-delivered wound assessment']","['acute healthcare services', 'time-to-diagnosis of SSI with secondary outcome measures considering use of emergency department and general practitioner services and patient experience']","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C3665347', 'cui_str': 'Visual Impairment'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032786', 'cui_str': 'Postoperative Care'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0040480', 'cui_str': 'Musculoskeletal torsion (observable entity)'}, {'cui': 'C0558033', 'cui_str': 'Wound assessment'}]","[{'cui': 'C0557829', 'cui_str': 'Healthcare services (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",500.0,0.194521,"Over three-quarters of UK adults now own smartphones, which could be harnessed to improve access to care.","[{'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'McLean', 'Affiliation': 'Department of Clinical Surgery, University of Edinburgh, 51 Little France Crescent, Edinburgh, UK v1kmcle6@ed.ac.uk.'}, {'ForeName': 'Katie E', 'Initials': 'KE', 'LastName': 'Mountain', 'Affiliation': 'Department of Clinical Surgery, University of Edinburgh, 51 Little France Crescent, Edinburgh, UK.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Shaw', 'Affiliation': 'Department of Clinical Surgery, University of Edinburgh, 51 Little France Crescent, Edinburgh, UK.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Drake', 'Affiliation': 'Department of Clinical Surgery, University of Edinburgh, 51 Little France Crescent, Edinburgh, UK.'}, {'ForeName': 'Riinu', 'Initials': 'R', 'LastName': 'Ots', 'Affiliation': 'Department of Clinical Surgery, University of Edinburgh, 51 Little France Crescent, Edinburgh, UK.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Knight', 'Affiliation': 'Department of Clinical Surgery, University of Edinburgh, 51 Little France Crescent, Edinburgh, UK.'}, {'ForeName': 'Cameron J', 'Initials': 'CJ', 'LastName': 'Fairfield', 'Affiliation': 'Department of Clinical Surgery, University of Edinburgh, 51 Little France Crescent, Edinburgh, UK.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sgrò', 'Affiliation': 'Department of Clinical Surgery, University of Edinburgh, 51 Little France Crescent, Edinburgh, UK.'}, {'ForeName': 'Richard J E', 'Initials': 'RJE', 'LastName': 'Skipworth', 'Affiliation': 'Department of Clinical Surgery, University of Edinburgh, 51 Little France Crescent, Edinburgh, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Wigmore', 'Affiliation': 'Department of Clinical Surgery, University of Edinburgh, 51 Little France Crescent, Edinburgh, UK.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Potter', 'Affiliation': 'Department of Colorectal Surgery, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Ewen M', 'Initials': 'EM', 'LastName': 'Harrison', 'Affiliation': 'Department of Clinical Surgery, University of Edinburgh, 51 Little France Crescent, Edinburgh, UK.'}]",BMJ open,['10.1136/bmjopen-2019-029620']
358,31594904,Ageing stereotypes and prodromal Alzheimer's disease (AGING): study protocol for an ongoing randomised clinical study.,"INTRODUCTION


The number of older people diagnosed with amnestic mild cognitive impairment (aMCI), the prodromal state of Alzheimer's disease (AD), is increasing worldwide. However, some patients with aMCI never convert to the AD type of dementia, with some remaining stable and others reverting to normal. This overdiagnosis bias has been largely overlooked and gone unexplained. There is ample evidence in the laboratory that negative ageing stereotypes (eg, the culturally shared belief that ageing inescapably causes severe cognitive decline) contribute to the deteriorating cognitive performances of healthy older adults, leading them to perform below their true abilities. The study described here is intended to test for the first time whether such stereotypes also impair patients' cognitive performances during neuropsychological examinations in memory clinics, resulting in overdiagnosis of aMCI.
METHODS AND ANALYSIS


The ongoing study is a 4-year randomised clinical trial comparing patients' physiological stress and cognitive performances during neuropsychological testing in memory clinics. A total of 260 patients attending their first cognitive evaluation will be randomised to either a standard condition of test administration, assumed here to implicitly activate negative ageing stereotypes or a reduced-threat instruction condition designed to alleviate the anxiety arising from these stereotypes. Both groups will be tested with the same test battery and stress biomarkers. For 30 patients diagnosed with aMCI in each group (n=60), biomarkers of neurodegeneration and amyloidopathy will be used to distinguish between aMCI with normal versus abnormal AD biomarkers. A 9-month follow-up will be performed on all patients to identify those whose cognitive performances remain stable, deteriorate or improve.
ETHICS AND DISSEMINATION


This protocol has been approved by the French National Agency for Medicines and Health Products Safety and the Sud-Est I French Ethics Committee (2017-A00946-47). Results will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03138018.",2019,"For 30 patients diagnosed with aMCI in each group (n=60), biomarkers of neurodegeneration and amyloidopathy will be used to distinguish between aMCI with normal versus abnormal AD biomarkers.","[""older people diagnosed with amnestic mild cognitive impairment (aMCI), the prodromal state of Alzheimer's disease (AD"", '260 patients attending their first cognitive evaluation', '30 patients diagnosed with aMCI in each group (n=60), biomarkers of neurodegeneration and amyloidopathy will be used to distinguish between aMCI with normal versus abnormal AD biomarkers', ""patients' physiological stress and cognitive performances during neuropsychological testing in memory clinics"", 'healthy older adults']",['implicitly activate negative ageing stereotypes or a reduced-threat instruction condition designed to alleviate the anxiety arising from these stereotypes'],[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C3494359', 'cui_str': 'Prodromal States'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0449430', 'cui_str': 'Physiological Stress'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}]",[],260.0,0.0757039,"For 30 patients diagnosed with aMCI in each group (n=60), biomarkers of neurodegeneration and amyloidopathy will be used to distinguish between aMCI with normal versus abnormal AD biomarkers.","[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Gauthier', 'Affiliation': 'Aix Marseille Univ, CNRS, LPC, Marseille, France.'}, {'ForeName': 'Alexandrine', 'Initials': 'A', 'LastName': 'Morand', 'Affiliation': 'Normandie Université, UNICAEN, PSL Universités Paris, EPHE, INSERM, U1077, CHU de Caen, Neuropsychologie et Imagerie de la Mémoire Humaine, Caen, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Dutheil', 'Affiliation': 'Université Clermont Auvergne, CNRS, LAPSCO, Clermont-Ferrand, France.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Alescio-Lautier', 'Affiliation': 'Aix Marseille Univ, CNRS, LNSC, Marseille, France.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Boucraut', 'Affiliation': 'Immunology Laboratory, Assistance Publique-Hôpitaux de Marseille, Conception Hospital, Marseille, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Clarys', 'Affiliation': ""Centre de Recherches sur la Cognition et l'Apprentissage, CNRS, Université de Poitiers, Université de Tours, Poitiers, France.""}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Eustache', 'Affiliation': 'Normandie Université, UNICAEN, PSL Universités Paris, EPHE, INSERM, U1077, CHU de Caen, Neuropsychologie et Imagerie de la Mémoire Humaine, Caen, France.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Girard', 'Affiliation': 'Aix Marseille Univ, CRMBM UMR CNRS 7339, APHM Timone Neuroradiologie, Marseille, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Guedj', 'Affiliation': 'Aix Marseille Univ, CNRS, Ecole Centrale Marseille, UMR 7249, Institut Fresnel, & Department of Nuclear Medicine, Assistance Publique-Hôpitaux de Marseille, Timone University Hospital, Marseille, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Mazerolle', 'Affiliation': 'Department and Laboratory of Psychology, MSHE, Université Bourgogne Franche-Comté, Besançon, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Paccalin', 'Affiliation': ""Centre d'Investigation Clinique CIC 1402, INSERM, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'de la Sayette', 'Affiliation': 'Normandie Université, UNICAEN, PSL Universités Paris, EPHE, INSERM, U1077, CHU de Caen, Neuropsychologie et Imagerie de la Mémoire Humaine, Caen, France.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Zaréa', 'Affiliation': 'Department of Neurology, Rouen University Hospital and University of Rouen, Rouen, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Huguet', 'Affiliation': 'Université Clermont Auvergne, CNRS, LAPSCO, Clermont-Ferrand, France.'}, {'ForeName': 'Bernard F', 'Initials': 'BF', 'LastName': 'Michel', 'Affiliation': 'Departement of Neurological Behavior, Assistance Publique-Hôpitaux de Marseille, Sainte-Marguerite University Hospital, Marseille, France.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Desgranges', 'Affiliation': 'Normandie Université, UNICAEN, PSL Universités Paris, EPHE, INSERM, U1077, CHU de Caen, Neuropsychologie et Imagerie de la Mémoire Humaine, Caen, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Régner', 'Affiliation': 'Aix Marseille Univ, CNRS, LPC, Marseille, France isabelle.regner@univ-amu.fr.'}]",BMJ open,['10.1136/bmjopen-2019-032265']
359,32198520,Proactively Offered Text Messages and Mailed Nicotine Replacement Therapy for Smokers in Primary Care Practices: A Pilot Randomized Trial.,"INTRODUCTION


Proactive, population health cessation programs can guide efforts to reach smokers outside of the clinic to encourage quit attempts and treatment use.
AIMS AND METHODS


This study aimed to measure trial feasibility and preliminary effects of a proactive intervention offering text messages (TM) and/or mailed nicotine replacement therapy (NRT) to smokers in primary care clinics. From 2017 to 2019 we performed a pilot randomized trial comparing brief telephone advice (control: BA), TM, 2 weeks of mailed NRT, or both interventions (TM + NRT). Patients were identified using electronic health records and contacted proactively by telephone to assess interest in the study. We compared quit attempts, treatment use, and cessation in the intervention arms with BA.
RESULTS


Of 986 patients contacted, 153 (16%) enrolled (mean age 53 years, 57% female, 76% white, 11% black, 8% Hispanic, 52% insured by Medicaid) and 144 (94%) completed the 12-week assessment. On average, patients in the TM arms received 159 messages (99.4% sent, 0.6% failed), sent 19 messages, and stayed in the program for 61 days. In all groups, a majority of patients reported quit attempts (BA 67% vs. TM 86% [p = .07], NRT 81% [p = .18], TM + NRT 79% [p = .21]) and NRT use (BA 51% vs. NRT 83% [p = .007], TM 65% [p = .25], TM + NRT 76% [p = .03]). Effect estimates for reported 7-day abstinence were BA 10% versus TM 26% (p = .09), NRT 28% (p = .06), and TM + NRT 23% (p = .14).
CONCLUSIONS


Proactively offering TM or mailed nicotine medications was feasible among primary care smokers and a promising approach to promote quit attempts and short-term abstinence.
IMPLICATIONS


Proactive intervention programs to promote quit attempts outside of office visits among smokers enrolled in primary care practices are needed. TM have potential to engage smokers not planning to quit or to support smokers to make a planned quit attempt. This pilot study demonstrates the feasibility of testing a proactive treatment model including TM and/or mailed NRT to promote quit attempts, treatment use, and cessation among nontreatment-seeking smokers in primary care.
CLINICALTRIALS.GOV IDENTIFIER


NCT03174158.",2020,"Effect estimates for reported 7-day abstinence were BA 10% versus TM 26% (p=0.09), NRT 28% (p=0.06), and TM+NRT 23% (p=0.14).
","['smokers in primary care practices', 'From 2017-2019', '986 patients contacted, 153 (16%) enrolled (mean age 53 years, 57% female, 76% white, 11% black, 8% Hispanic, 52% insured by Medicaid) and 144 (94%) completed the 12-week assessment', 'smokers in primary care clinics', 'primary care smokers']","['proactive intervention offering text messages and/or mailed nicotine replacement therapy (NRT', 'nicotine medications', 'telephone advice (control: BA), text messages (TM), 2-weeks of mailed NRT, or both interventions (TM+NRT', 'nicotine replacement therapy']","['7-day abstinence', 'quit attempts']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.0423889,"Effect estimates for reported 7-day abstinence were BA 10% versus TM 26% (p=0.09), NRT 28% (p=0.06), and TM+NRT 23% (p=0.14).
","[{'ForeName': 'Gina R', 'Initials': 'GR', 'LastName': 'Kruse', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Tobacco Research and Treatment Center, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Haberer', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Lorien C', 'Initials': 'LC', 'LastName': 'Abroms', 'Affiliation': 'Department of Prevention and Community Health, Milken Institute School of Public Health, George Washington University, Washington, DC.'}, {'ForeName': 'Naysha N', 'Initials': 'NN', 'LastName': 'Shahid', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Howard', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Haas', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa050']
360,31884854,"Effects of Interleukin-1β Inhibition on Blood Pressure, Incident Hypertension, and Residual Inflammatory Risk: A Secondary Analysis of CANTOS.","While hypertension and inflammation are physiologically inter-related, the effect of therapies that specifically target inflammation on blood pressure is uncertain. The recent CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcomes Study) afforded the opportunity to test whether IL (interleukin)-1β inhibition would reduce blood pressure, prevent incident hypertension, and modify relationships between hypertension and cardiovascular events. CANTOS randomized 10 061 patients with prior myocardial infarction and hsCRP (high sensitivity C-reactive protein) ≥2 mg/L to canakinumab 50 mg, 150 mg, 300 mg, or placebo. A total of 9549 trial participants had blood pressure recordings during follow-up; of these, 80% had a preexisting diagnosis of hypertension. In patients without baseline hypertension, rates of incident hypertension were 23.4, 26.6, and 28.1 per 100-person years for the lowest to highest baseline tertiles of hsCRP ( P >0.2). In all participants random allocation to canakinumab did not reduce blood pressure ( P >0.2) or incident hypertension during the follow-up period (hazard ratio, 0.96 [0.85-1.08],  P >0.2). IL-1β inhibition with canakinumab reduces major adverse cardiovascular event rates. These analyses suggest that the mechanisms underlying this benefit are not related to changes in blood pressure or incident hypertension. Clinical Trial Registration- URL: https://clinicaltrials.gov. Unique identifier: NCT01327846.",2020,"In all participants random allocation to canakinumab did not reduce blood pressure ( P >0.2) or incident hypertension during the follow-up period (hazard ratio, 0.96 [0.85-1.08],  P >0.2).","['061 patients with prior myocardial infarction and hsCRP (high sensitivity C-reactive protein) ≥2 mg', 'A total of 9549 trial participants had blood pressure recordings during follow-up; of these, 80% had a preexisting diagnosis of hypertension']","['L to canakinumab 50 mg, 150 mg, 300 mg, or placebo', 'Interleukin-1β Inhibition', 'IL (interleukin)-1β inhibition']","['Blood Pressure, Incident Hypertension, and Residual Inflammatory Risk', 'blood pressure or incident hypertension', 'rates of incident hypertension', 'incident hypertension', 'blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.224736,"In all participants random allocation to canakinumab did not reduce blood pressure ( P >0.2) or incident hypertension during the follow-up period (hazard ratio, 0.96 [0.85-1.08],  P >0.2).","[{'ForeName': 'Alexander Mk', 'Initials': 'AM', 'LastName': 'Rothman', 'Affiliation': 'From the Department of Cardiology, Chesterman Cardiothoracic Unit, Northern General Hospital, Sheffield, United Kingdom (A.M.K.R.).'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'MacFadyen', 'Affiliation': ""Center for Cardiovascular Disease Prevention (J.M., R.J.G., P.M.R.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Thuren', 'Affiliation': 'Novartis Pharmaceutical Corporation, One Health Plaza, East Hanover, NJ (T.T.).'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Webb', 'Affiliation': 'Centre for Prevention of Stroke and Dementia, Department of Clinical Neurosciences, University of Oxford, United Kingdom (A.W.).'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Harrison', 'Affiliation': 'Vanderbilt University, Nashville, TN (D.G.H.).'}, {'ForeName': 'Tomasz J', 'Initials': 'TJ', 'LastName': 'Guzik', 'Affiliation': 'Institute of Cardiovascular and Medical Research, Queen Elizabeth University Hospital, University of Glasgow (T.J.G.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Libby', 'Affiliation': ""Cardiovascular Division (P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Center for Cardiovascular Disease Prevention (J.M., R.J.G., P.M.R.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Center for Cardiovascular Disease Prevention (J.M., R.J.G., P.M.R.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.119.13642']
361,32131781,"""The cord is the child"": meanings and practices related to umbilical cord care in Central Uganda.","BACKGROUND


Infections account for a quarter of all newborn deaths and the umbilical cord has been identified as a major route of newborn infections.
OBJECTIVE


To explore the meanings and practices related to the umbilical cord among caretakers of newborns in central Uganda.
METHODS


This was a qualitative study, designed to inform the design, and interpretation of a randomized controlled trial assessing the effectiveness of chlorhexidine use for the umbilical cord. We conducted 22 in-depth interviews exploring umbilical cord care practices among ten mothers, four health workers, five traditional birth attendants, and three men. We also conducted three focus group discussions with young mothers and elderly women. We used qualitative content analysis to analyze our findings and we borrow upon Mary Douglas' concepts of dirt to present our findings.
RESULTS


The umbilical cord had a symbolic position in newborn care. The way it was perceived and handled had far reaching consequences for the survival and wellbeing of the baby. The umbilical cord was a centre of anxiety, a possible gate to illness, a test of fatherhood and a signifier of parental responsibility. Hence, the umbilical cord and the way it was cared for played a part in the present and future survival of the baby, as well as the survival and wellbeing of the household. Persons other than the mother such as older female relatives were very influential in the care of the umbilical cord.
CONCLUSIONS


The umbilical cord carried symbolic meanings, which extended beyond the newborn and the newborn period, and in turn influenced the various practices of umbilical cord care. The important position of the cord in local newborn care practices should be recognized and taken into consideration when scaling up newborn care interventions in the country.",2020,"The umbilical cord was a centre of anxiety, a possible gate to illness, a test of fatherhood and a signifier of parental responsibility.","['young mothers and elderly women', '22 in-depth interviews exploring umbilical cord care practices among ten mothers, four health workers, five traditional birth attendants, and three men']",['chlorhexidine'],[],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0040600', 'cui_str': 'Traditional Birth Attendant'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}]",[],,0.0446518,"The umbilical cord was a centre of anxiety, a possible gate to illness, a test of fatherhood and a signifier of parental responsibility.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mukunya', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health (www.cismac.org), Center for International Health, University of Bergen, Bergen, Norway. zebdaevid@gmail.com.'}, {'ForeName': 'Marte E S', 'Initials': 'MES', 'LastName': 'Haaland', 'Affiliation': 'CISMAC, Center for International Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Tumwine', 'Affiliation': 'Department of Pediatrics and Child Health, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Thorkild', 'Initials': 'T', 'LastName': 'Tylleskar', 'Affiliation': 'CISMAC, Center for International Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Nankabirwa', 'Affiliation': 'CISMAC, Center for International Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Karen Marie', 'Initials': 'KM', 'LastName': 'Moland', 'Affiliation': 'CISMAC, Center for International Health, University of Bergen, Bergen, Norway.'}]",BMC pediatrics,['10.1186/s12887-020-2002-9']
362,32196954,Levocetirizine Oral Disintegrating Tablet: A Randomized Open-Label Crossover Bioequivalence Study in Healthy Japanese Volunteers.,"Levocetirizine is classified as a second-generation antihistamine. Levocetirizine is available for the treatment of allergic disorders such as allergic rhinitis and chronic idiopathic urticaria. This was a single-center, single-dose, open-label, randomized, 2-way crossover study in healthy Japanese male subjects consisting of 2 parts. Part 1 compared the bioavailability of levocetirizine oral disintegrating tablet (ODT) and levocetirizine immediate-release tablet (IRT) taken with water in the fasted state in 24 subjects; all subjects completed this part of the trial. In part 2, the bioavailability of levocetirizine ODT without water was compared with that of levocetirizine IRT with water in the fasted state in 48 subjects; 47 subjects completed this part of the trial. Bioequivalence was demonstrated between levocetirizine IRT 5 mg and ODT 5 mg. The safety profiles were generally similar between levocetirizine ODT and levocetirizine IRT, with no serious adverse events, deaths, or adverse events leading to withdrawal reported during the study.",2020,"The safety profiles were generally similar between levocetirizine ODT and levocetirizine IRT, with no serious adverse events, deaths, or adverse events leading to withdrawal reported during the study.","['Healthy Japanese Volunteers', '24 subjects', 'healthy Japanese male subjects consisting of 2 parts', '48 subjects; 47 subjects completed this part of the trial']","['levocetirizine ODT and levocetirizine IRT', 'levocetirizine ODT', 'Levocetirizine', 'Levocetirizine Oral Disintegrating Tablet', 'levocetirizine oral disintegrating tablet (ODT) and levocetirizine immediate-release tablet (IRT', 'levocetirizine IRT']","['serious adverse events, deaths, or adverse events']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}]","[{'cui': 'C1174893', 'cui_str': 'levocetirizine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",48.0,0.011894,"The safety profiles were generally similar between levocetirizine ODT and levocetirizine IRT, with no serious adverse events, deaths, or adverse events leading to withdrawal reported during the study.","[{'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Ino', 'Affiliation': 'Clinical Pharmacology Office, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Masanari', 'Initials': 'M', 'LastName': 'Shiramoto', 'Affiliation': 'Souseikai Hakata Clinic, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Eto', 'Affiliation': 'Souseikai Hakata Clinic, Fukuoka, Japan.'}, {'ForeName': 'Miwa', 'Initials': 'M', 'LastName': 'Haranaka', 'Affiliation': 'Souseikai Hakata Clinic, Fukuoka, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Irie', 'Affiliation': 'Souseikai Hakata Clinic, Fukuoka, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Terao', 'Affiliation': 'Biomedical Data Sciences Department, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Ogura', 'Affiliation': 'Clinical Pharmacology Office, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Wakamatsu', 'Affiliation': 'Pre-Clinical Development Department, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Hoyano', 'Affiliation': 'Biomedical Data Sciences Department, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakano', 'Affiliation': 'Immuno-Inflammation Therapeutic Office, Medicines Development, Japan Development, GlaxoSmithKline KK, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.791']
363,32196976,The Bioequivalence of Tafamidis 61-mg Free Acid Capsules and Tafamidis Meglumine 4 × 20-mg Capsules in Healthy Volunteers.,"Tafamidis, a non-nonsteroidal anti-inflammatory benzoxazole derivative, acts as a transthyretin (TTR) stabilizer to slow progression of TTR amyloidosis (ATTR). Tafamidis meglumine, available as 20-mg capsules, is approved in more than 40 countries worldwide for the treatment of adults with early-stage symptomatic ATTR polyneuropathy. This agent, administered as an 80-mg, once-daily dose (4 × 20-mg capsules), is approved in the United States, Japan, Canada, and Brazil for the treatment of hereditary and wild-type ATTR cardiomyopathy in adults. An alternative single solid oral dosage formulation (tafamidis 61-mg free acid capsules) was developed and introduced for patient convenience (approved in the United States, United Arab Emirates, and European Union). In this single-center, open-label, randomized, 2-period, 2-sequence, crossover, multiple-dose phase 1 study, the rate and extent of absorption were compared between tafamidis 61-mg free acid capsules (test) and tafamidis meglumine 80-mg (4 × 20-mg) capsules (reference) after 7 days of repeated oral dosing under fasted conditions in 30 healthy volunteers. Ratios of adjusted geometric means (90%CI) for the test/reference formulations were 102.3 (98.0-106.8) for area under the concentration-time profile over the dosing interval and 94.1 (89.1-99.4) for the maximum observed concentration, satisfying prespecified bioequivalence acceptance criteria (90%CI, 80-125). Both tafamidis regimens had an acceptable safety/tolerability profile in this population.",2020,"Ratios of adjusted geometric means (90%CI) for the test/reference formulations were 102.3 (98.0-106.8) for area under the concentration-time profile over the dosing interval and 94.1 (89.1-99.4) for the maximum observed concentration, satisfying prespecified bioequivalence acceptance criteria (90%CI, 80-125).","['30 healthy volunteers', 'adults with early-stage symptomatic ATTR polyneuropathy', 'Healthy Volunteers']","['Tafamidis 61-mg Free Acid Capsules and Tafamidis Meglumine', 'Tafamidis meglumine']","['acceptable safety/tolerability profile', 'Ratios of adjusted geometric means (90%CI']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}]","[{'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C2745275', 'cui_str': 'Tafamidis meglumine'}]","[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",30.0,0.0586977,"Ratios of adjusted geometric means (90%CI) for the test/reference formulations were 102.3 (98.0-106.8) for area under the concentration-time profile over the dosing interval and 94.1 (89.1-99.4) for the maximum observed concentration, satisfying prespecified bioequivalence acceptance criteria (90%CI, 80-125).","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Lockwood', 'Affiliation': 'Pfizer, Groton, Connecticut, USA.'}, {'ForeName': 'Vu H', 'Initials': 'VH', 'LastName': 'Le', 'Affiliation': 'Pfizer, Groton, Connecticut, USA.'}, {'ForeName': 'Melissa T', 'Initials': 'MT', 'LastName': ""O'Gorman"", 'Affiliation': 'Pfizer, New York, New York, USA.'}, {'ForeName': 'Terrell A', 'Initials': 'TA', 'LastName': 'Patterson', 'Affiliation': 'Pfizer, Groton, Connecticut, USA.'}, {'ForeName': 'Marla B', 'Initials': 'MB', 'LastName': 'Sultan', 'Affiliation': 'Pfizer, New York, New York, USA.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Tankisheva', 'Affiliation': 'Pfizer, Brussels, Belgium.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Pfizer Beijing City, China.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Riley', 'Affiliation': 'Pfizer, Groton, Connecticut, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.789']
364,32145739,Adolescent Interventions to Manage Self-Regulation in Type 1 Diabetes (AIMS-T1D): randomized control trial study protocol.,"BACKGROUND


Self-regulation (SR), or the capacity to control one's thoughts, emotions, and behaviors in order to achieve a desired goal, shapes health outcomes through many pathways, including supporting adherence to medical treatment regimens. Type 1 Diabetes (T1D) is one specific condition that requires SR to ensure adherence to daily treatment regimens that can be arduous and effortful (e.g., monitoring blood glucose). Adolescents, in particular, have poor adherence to T1D treatment regimens, yet it is essential that they assume increased responsibility for managing their T1D as they approach young adulthood. Adolescence is also a time of rapid changes in SR capacity and thus a compelling period for intervention. Promoting SR among adolescents with T1D may thus be a novel method to improve treatment regimen adherence. The current study tests a behavioral intervention to enhance SR among adolescents with T1D. SR and T1D medical regimen adherence will be examined as primary and secondary outcomes, respectively.
METHODS


We will use a randomized control trial design to test the impact of a behavioral intervention on three SR targets: Executive Functioning (EF), Emotion Regulation (ER), and Future Orientation (FO); and T1D medical regimen adherence. Adolescents with T1D (n = 94) will be recruited from pediatric endocrinology clinics and randomly assigned to treatment or control group. The behavioral intervention consists of working memory training (to enhance EF), biofeedback and relaxation training (to enhance ER), and episodic future thinking training (to enhance FO) across an 8-week period. SR and treatment regimen adherence will be assessed at pre- and post-test using multiple methods (behavioral tasks, diabetes device downloads, self- and parent-report). We will use an intent-to-treat framework using generalized linear mixed models to test our hypotheses that: 1) the treatment group will demonstrate greater improvements in SR than the control group, and 2) the treatment group will demonstrate better treatment regimen adherence outcomes than the control group.
DISCUSSION


If successful, SR-focused behavioral interventions could improve health outcomes among adolescents with T1D and have transdiagnostic implications across multiple chronic conditions requiring treatment regimen adherence.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03688919; registered September 28, 2018.",2020,"If successful, SR-focused behavioral interventions could improve health outcomes among adolescents with T1D and have transdiagnostic implications across multiple chronic conditions requiring treatment regimen adherence.
","['adolescents with T1D', 'Adolescents with T1D', 'adolescents with T1D. SR and T1D medical regimen adherence']","['behavioral intervention', 'Adolescent Interventions', 'working memory training (to enhance EF), biofeedback and relaxation training (to enhance ER), and episodic future thinking training']","['health outcomes', 'SR targets: Executive Functioning (EF), Emotion Regulation (ER), and Future Orientation (FO); and T1D medical regimen adherence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0016884', 'cui_str': 'Future'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]",,0.037512,"If successful, SR-focused behavioral interventions could improve health outcomes among adolescents with T1D and have transdiagnostic implications across multiple chronic conditions requiring treatment regimen adherence.
","[{'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Miller', 'Affiliation': 'Department of Health Behavior and Health Education, University of Michigan School of Public Health, 1415 Washington Heights, SPH I Room 3718, Ann Arbor, MI, 48109-2029, USA. alimill@umich.edu.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Lo', 'Affiliation': 'Department of Health Behavior and Health Education, University of Michigan School of Public Health, 1415 Washington Heights, SPH I Room 3718, Ann Arbor, MI, 48109-2029, USA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Albright', 'Affiliation': 'Department of Pediatrics, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Joyce M', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Hunter', 'Affiliation': 'Office of Behavioral and Social Sciences Research, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Katherine W', 'Initials': 'KW', 'LastName': 'Bauer', 'Affiliation': 'Center for Human Growth and Development, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'King', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Katy M', 'Initials': 'KM', 'LastName': 'Clark', 'Affiliation': 'Department of Health Behavior and Health Education, University of Michigan School of Public Health, 1415 Washington Heights, SPH I Room 3718, Ann Arbor, MI, 48109-2029, USA.'}, {'ForeName': 'Kiren', 'Initials': 'K', 'LastName': 'Chaudhry', 'Affiliation': 'Department of Health Behavior and Health Education, University of Michigan School of Public Health, 1415 Washington Heights, SPH I Room 3718, Ann Arbor, MI, 48109-2029, USA.'}, {'ForeName': 'Niko', 'Initials': 'N', 'LastName': 'Kaciroti', 'Affiliation': 'Department of Pediatrics, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Katz', 'Affiliation': 'Department of Human Development and Family Science, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Fredericks', 'Affiliation': 'Department of Pediatrics, University of Michigan Medical School, Ann Arbor, MI, USA.'}]",BMC pediatrics,['10.1186/s12887-020-2012-7']
365,31972958,"Safety and Efficacy of a New Synthetic Material Based on Monetite, Silica Gel, PS-Wallastonite, and a Hydroxyapatite Calcium Deficient: A Randomized Comparative Clinic Trial.","Background and Objectives : Maxillary bone defects related to post-extraction alveolar ridge resorption are usual. These defects may lead to failure in further surgical implant phases given the lack of bone volume to perform the dental implant. The objective of this clinical assay was to evaluate the safety and efficacy of an experimental synthetic bone substitute in the preservation of post-extraction maxillary alveoli.  Materials and Methods : 33 voluntary patients who had at least one maxillary premolar tooth that was a candidate for exodontia ( n  = 39) and subsequent implant rehabilitation participated. The regenerated alveoli were monitored by means of periodic clinical examinations (days 9 ± 1, 21 ± 4, 42 ± 6, and 84 ± 6), measuring the height and width of the alveolar crest (days 0 and 180 ± 5), measurement of radiodensity using tomographic techniques (days 0-5 and 175 ± 5), and histological examination of biopsies collected at 180 ± 5 days.  Results : No significant differences were observed during the entire follow-up period between the two groups with respect to the safety variables studied. A variation in width of -0.9 ± 1.3 mm and -0.6 ± 1.5 mm, and a variation in height of -0.1 ± 0.9 mm and -0.3 ± 0.7 mm was observed for experimental material Sil-Oss ®  and Bio-Oss ® , respectively. The radiodensity of the alveoli regenerated with the experimental material was significantly lower than that corresponding to Bio-Oss ® . However, the histological study showed greater osteoid matrix and replacement of the material with newformed bone in the implanted beds with the experimental material.  Conclusions:  Both materials can be used safely and proved equally effective in maintaining alveolar flange dimensions, they are also histologically biocompatible, bioactive and osteoconductive. The experimental material showed the advantage of being resorbable and replaced with newformed bone, in addition to promoting bone regeneration.",2020,No significant differences were observed during the entire follow-up period between the two groups with respect to the safety variables studied.,['Materials and Methods : 33 voluntary patients who had at least one maxillary premolar tooth that was a candidate for exodontia ( n  = 39) and subsequent implant rehabilitation participated'],"['New Synthetic Material Based on Monetite, Silica Gel, PS-Wallastonite, and a Hydroxyapatite Calcium Deficient', 'experimental synthetic bone substitute']","['Safety and Efficacy', 'safety and efficacy']","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0580276', 'cui_str': 'Informal patient (finding)'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0040440', 'cui_str': 'Tooth Extraction'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0440251', 'cui_str': 'Synthetic material (substance)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243631', 'cui_str': 'calcium phosphate (CaHPO4)'}, {'cui': 'C2936385', 'cui_str': 'Silica Gel'}, {'cui': 'C0115137', 'cui_str': 'Durapatite'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0243003', 'cui_str': 'Bone Replacement Materials'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",33.0,0.046328,No significant differences were observed during the entire follow-up period between the two groups with respect to the safety variables studied.,"[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Flores Fraile', 'Affiliation': 'Department of Surgery, University of Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), 37007 Salamanca, Spain.'}, {'ForeName': 'Nansi', 'Initials': 'N', 'LastName': 'López-Valverde', 'Affiliation': 'Department of Surgery, University of Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), 37007 Salamanca, Spain.'}, {'ForeName': 'Arcadio', 'Initials': 'A', 'LastName': 'García de Castro Andews', 'Affiliation': 'Science to Business Foundation, 28760 Madrid, Spain.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Santos Marino', 'Affiliation': 'Department of Surgery, University of Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), 37007 Salamanca, Spain.'}, {'ForeName': 'Juan M', 'Initials': 'JM', 'LastName': 'Ramírez', 'Affiliation': 'Department of Morphological Sciences, University of Cordoba, 14071 Cordoba, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Gómez de Diego', 'Affiliation': 'Department of Oral Medicine, Rey Juan Carlos University, 28922 Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Montero', 'Affiliation': 'Department of Surgery, University of Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), 37007 Salamanca, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'López-Valverde', 'Affiliation': 'Department of Surgery, University of Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), 37007 Salamanca, Spain.'}, {'ForeName': 'Leticia Alejandra', 'Initials': 'LA', 'LastName': 'Blanco Antona', 'Affiliation': 'Department of Surgery, University of Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), 37007 Salamanca, Spain.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56020046']
366,32024027,Oral Supplementation with Sucrosomial Ferric Pyrophosphate Plus L-Ascorbic Acid to Ameliorate the Martial Status: A Randomized Controlled Trial.,"Altered martial indices before orthopedic surgery are associated with higher rates of complications and greatly affect the patient's functional ability. Oral supplements can optimize the preoperative martial status, with clinical efficacy and the patient's tolerability being highly dependent on the pharmaceutical formula. Patients undergoing elective hip/knee arthroplasty were randomized to be supplemented with a 30-day oral therapy of sucrosomial ferric pyrophosphate plus L-ascorbic acid. The tolerability was 2.7% among treated patients. Adjustments for confounding factors, such as iron absorption influencers, showed a relevant response limited to older patients (≥ 65 years old), whose uncharacterized Hb loss was averted upon treatment with iron formula. Older patients with no support lost -2.8 ± 5.1%, while the intervention group gained +0.7 ± 4.6% of circulating hemoglobin from baseline ( p  = 0.019). Gastrointestinal diseases, medications, and possible dietary factors could affect the efficacy of iron supplements. Future opportunities may consider to couple ferric pyrophosphate with other nutrients, to pay attention in avoiding absorption disruptors, or to implement interventions to obtain an earlier martial status optimization at the population level.",2020,"Older patients with no support lost -2.8 ± 5.1%, while the intervention group gained +0.7 ± 4.6% of circulating hemoglobin from baseline ( p  = 0.019).","['Patients undergoing elective hip/knee arthroplasty', 'Martial Status', 'older patients (≥ 65 years old']","['Sucrosomial Ferric Pyrophosphate Plus L-Ascorbic Acid', '30-day oral therapy of sucrosomial ferric pyrophosphate plus L-ascorbic acid']",['tolerability'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0117541', 'cui_str': 'ferric pyrophosphate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0650399,"Older patients with no support lost -2.8 ± 5.1%, while the intervention group gained +0.7 ± 4.6% of circulating hemoglobin from baseline ( p  = 0.019).","[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Briguglio', 'Affiliation': 'IRCCS Orthopedic Institute Galeazzi, Scientific Direction, Via Riccardo Galeazzi 4, 20161 Milan, Italy.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Hrelia', 'Affiliation': ""University of Bologna, Department for Life Quality Studies, Corso d'Augusto 237, 47921 Rimini, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Malaguti', 'Affiliation': ""University of Bologna, Department for Life Quality Studies, Corso d'Augusto 237, 47921 Rimini, Italy.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'De Vecchi', 'Affiliation': 'IRCCS Orthopedic Institute Galeazzi, Laboratory of Clinical Chemistry and Microbiology, Via Riccardo Galeazzi 4, 20161 Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Lombardi', 'Affiliation': 'IRCCS Orthopedic Institute Galeazzi, Laboratory of Experimental Biochemistry and Molecular Biology, Via Riccardo Galeazzi 4, 20161 Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Banfi', 'Affiliation': 'IRCCS Orthopedic Institute Galeazzi, Scientific Direction, Via Riccardo Galeazzi 4, 20161 Milan, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Riso', 'Affiliation': 'University of Milan, Department of Food, Environmental and Nutritional Sciences (DeFENS), Division of Human Nutrition, Via Mangiagalli 25, 20133 Milan, Italy.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Porrini', 'Affiliation': 'University of Milan, Department of Food, Environmental and Nutritional Sciences (DeFENS), Division of Human Nutrition, Via Mangiagalli 25, 20133 Milan, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Romagnoli', 'Affiliation': 'IRCCS Orthopedic Institute Galeazzi, Joint Replacement Department, Via Riccardo Galeazzi 4, 20161 Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Pino', 'Affiliation': 'IRCCS Orthopedic Institute Galeazzi, Post-operative Intensive Care Unit & Anesthesia, Via Riccardo Galeazzi 4, 20161 Milan, Italy.'}, {'ForeName': 'Tiziano', 'Initials': 'T', 'LastName': 'Crespi', 'Affiliation': 'IRCCS Orthopedic Institute Galeazzi, Post-operative Intensive Care Unit & Anesthesia, Via Riccardo Galeazzi 4, 20161 Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Perazzo', 'Affiliation': 'IRCCS Orthopedic Institute Galeazzi, Post-operative Intensive Care Unit & Anesthesia, Via Riccardo Galeazzi 4, 20161 Milan, Italy.'}]",Nutrients,['10.3390/nu12020386']
367,32187390,The effectiveness of an exercise intervention in reducing the severity of postpartum depression: A randomized controlled trial.,"PURPOSE


This study aims to identify the effectiveness of an exercise program in reducing the severity of postnatal depression in women who had a spontaneous vaginal delivery.
DESIGN AND METHODS


This randomized control trial was conducted with 65 postpartum women residing in a city located in south-eastern Turkey. In the first postpartum month, following random assignment of subjects, the experimental group (n = 40) performed exercises for 4 weeks, and the control group (n = 40) received standard care. The participating women were administered the Edinburgh postpartum depression scale.
FINDINGS


The average age of the participants was 28.90 ± 4.83 (min:19, max:40). Pretest mean depression scores of the exercises (16.41 ± 1.61) and control group (15.74 ± 2.35) were found to be similar, and there were no statistically significant differences (P > .05). After the 4-week exercise program, a statistically significant difference was found between the posttest mean scores of the exercises (7.29 ± 1.67) and control (12.54 ± 2.65) group participants. Pretest mean scores were found to be similar, and there were no statistically significant differences (Z = -6.501, P = .001).
CONCLUSION


The 4-week exercise program was found to be an effective method in decreasing the severity of depressive symptoms experienced in the postpartum period. Nurses and midwives providing care in the postpartum period are recommended to provide women in this period with exercise training.
PRACTICE IMPLICATIONS


Postpartum depression is a specific psychological disorder in which preventive interventions might lead to dramatic benefits. Exercises done in the postpartum period are reported to enable psychosocial well-being, less anxiety, and depression.",2020,"After the 4-week exercise program, a statistically significant difference was found between the posttest mean scores of the exercises (7.29 ± 1.67) and control (12.54 ± 2.65) group participants.","['women who had a spontaneous vaginal delivery', '65 postpartum women residing in a city located in south-eastern Turkey', 'The average age of the participants was 28.90\u2009±\u20094.83 (min:19, max:40']","['exercise intervention', 'exercise program', 'standard care']","['severity of postpartum depression', 'severity of depressive symptoms', 'Pretest mean depression scores']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1384485', 'cui_str': 'Delivery normal (finding)'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",65.0,0.0429695,"After the 4-week exercise program, a statistically significant difference was found between the posttest mean scores of the exercises (7.29 ± 1.67) and control (12.54 ± 2.65) group participants.","[{'ForeName': 'Semiha Aydın', 'Initials': 'SA', 'LastName': 'Özkan', 'Affiliation': 'Midwifery Department, Adiyaman University Faculty of Health, Adiyaman, Turkey.'}, {'ForeName': 'Didem Simsek', 'Initials': 'DS', 'LastName': 'Kücükkelepce', 'Affiliation': 'Midwifery Department, Adiyaman University Faculty of Health, Adiyaman, Turkey.'}, {'ForeName': 'Busra', 'Initials': 'B', 'LastName': 'Korkmaz', 'Affiliation': 'Midwifery Department, Adiyaman University Faculty of Health, Adiyaman, Turkey.'}, {'ForeName': 'Gizem', 'Initials': 'G', 'LastName': 'Yılmaz', 'Affiliation': 'Midwifery Department, Adiyaman University Faculty of Health, Adiyaman, Turkey.'}, {'ForeName': 'Merve Ayse', 'Initials': 'MA', 'LastName': 'Bozkurt', 'Affiliation': 'Midwifery Department, Adiyaman University Faculty of Health, Adiyaman, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12500']
368,32026323,Pilot Test of Connecting Pregnant Women who Smoke to Short Message Service (SMS) Support Texts for Cessation.,"INTRODUCTION


Most pregnant women know that smoking poses serious risks to baby and mother, yet many still smoke. We conducted a large randomized controlled trial and found that an SMS text-delivered program helped about 10% of these women quit smoking. In this paper, we describe the feasibility of disseminating a text-based intervention to pregnant women who smoke.
METHODS


We tested dissemination in two ways from prenatal clinics and compared recruitment rates to those found in our large randomized controlled trial. The first method involved ""direct texting"" where study staff identified women who smoked and sent them a text asking them to text back if they wanted to receive texts to help them quit. The second involved ""nurse screening"" where clinic staff from county health departments screened women for smoking and asked them to send a text to the system if they wanted to learn more about the program. Our primary outcome was feasibility assessed by the number of women who texted back their baby's due date, which served as ""enrolling"" in the texting program, which we compared to the recruitment rate we found in our large trial.
RESULTS


Over 4 months, we texted 91 women from the academic health system. Of those, 17 texted back and were counted as ""enrolled."" In the health departments, across the 4 months, 12 women texted the system initially. Of those, 10 were enrolled. This rate was similar to the rate enrolled in the randomized controlled trial.
DISCUSSION


Two different methods connected pregnant women who smoke to a texting program. One of these methods can be automated further and have the potential of helping many women quit smoking with minimal effort. Clinical Trial # NCT01995097.",2020,We conducted a large randomized controlled trial and found that an SMS text-delivered program helped about 10% of these women quit smoking.,"['pregnant women who smoke', 'pregnant women who smoke to a texting program', 'Connecting Pregnant Women who Smoke to Short Message Service (SMS) Support Texts for Cessation', '91 women from the academic health system']","['SMS text-delivered program', 'text-based intervention']",[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3178909'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],91.0,0.0638678,We conducted a large randomized controlled trial and found that an SMS text-delivered program helped about 10% of these women quit smoking.,"[{'ForeName': 'Kathryn I', 'Initials': 'KI', 'LastName': 'Pollak', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC, 27710, USA. kathryn.pollak@duke.edu.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Lyna', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC, 27710, USA.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC, 27710, USA.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Noonan', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC, 27710, USA.'}, {'ForeName': 'Santiago Bejarano', 'Initials': 'SB', 'LastName': 'Hernandez', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC, 27710, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Subudhi', 'Affiliation': 'Doctor of Medicine Program, Eastern Virginia Medical School, Norfolk, VA, 23507, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Kennedy', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC, 27710, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrell', 'Affiliation': 'People Designs, Inc, Durham, NC, USA.'}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University School of Medicine, DUMC 3083, Durham, NC, 27710, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Fish', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC, 27710, USA.'}]",Maternal and child health journal,['10.1007/s10995-020-02893-8']
369,30165750,Effect of the H 1 -antihistamine clemastine on PACAP38 induced migraine.,"OBJECTIVE


To investigate the effect of the H 1 -antihistamine clemastine on the migraine-inducing abilities of pituitary adenylate cyclase activating peptide-38.
METHODS


We conducted a double-blind, randomized, placebo controlled two-way cross-over study. Twenty migraine without aura patients were randomly allocated to receive bolus clemastine 2 mg (1 mg/ml) or bolus saline 2 ml intravenously over 2 min on two study days. Following each bolus injection, 10 pmol/kg/min of pituitary adenylate cyclase activating peptide-38 was administered intravenously over 20 min. We recorded migraine/headache characteristics every 10 min until 90 min after the start of infusion, and collected blood to investigate mast cell degranulation and the inflammation markers tryptase and tumor necrosis factor-alpha before and after infusion of pituitary adenylate cyclase activating peptide-38.
RESULTS


After clemastine pretreatment, five out of 20 participants developed a migraine-like attack in response to a pituitary adenylate cyclase activating peptide-38 infusion compared to nine out of 20 after placebo pretreatment ( p = 0.288). Following clemastine pretreatment, 15 out of 20 participants reported headache in response to a pituitary adenylate cyclase activating peptide-38 infusion, whereas 19 out of 20 participants did so following placebo pretreatment ( p = 0.221). We found no difference in area under the curve 12 h for headache intensity between the two experimental days ( p = 0.481). We found no difference in area under the curve 180 min for tryptase ( p = 0.525) or tumor necrosis factor-alpha ( p = 0.487) between clemastine and placebo pretreatment days.
CONCLUSION


H 1 -antihistamine, clemastine, failed to prevent migraine or headache after pituitary adenylate cyclase activating peptide-38 infusion, thus making a role for histamine release or mast cell degranulation in pituitary adenylate cyclase activating peptide-38-induced migraine less likely.",2019,"We found no difference in area under the curve 180 min for tryptase ( p = 0.525) or tumor necrosis factor-alpha ( p = 0.487) between clemastine and placebo pretreatment days.
",['Twenty migraine without aura patients'],"['bolus clemastine 2\u2009mg (1\u2009mg/ml) or bolus saline', 'placebo']","['headache in response to a pituitary adenylate cyclase activating peptide-38 infusion', 'migraine-like attack', 'headache intensity']","[{'cui': 'C0338480', 'cui_str': 'Migraine without Aura'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0008929', 'cui_str': 'Clemastine'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0001492', 'cui_str': 'Adenylate Cyclase'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",20.0,0.153044,"We found no difference in area under the curve 180 min for tryptase ( p = 0.525) or tumor necrosis factor-alpha ( p = 0.487) between clemastine and placebo pretreatment days.
","[{'ForeName': 'Luise Haulund', 'Initials': 'LH', 'LastName': 'Vollesen', 'Affiliation': '1 Danish Headache Centre and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': '1 Danish Headache Centre and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Malene Rohr', 'Initials': 'MR', 'LastName': 'Andersen', 'Affiliation': '2 Department of Clinical Biochemistry, Herlev and Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': '1 Danish Headache Centre and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102418798611']
370,32176565,Omega 3 Supplementation Can Regulate Inflammatory States in Gas Station Workers: A Double-Blind Placebo-Controlled Clinical Trial.,"Environmental exposure to diesel particulate matter and commercial gasoline in gas station workers might induce oxidative stress and changes in the balance of the immune system. In this study, the immunomodulatory impacts of omega 3 fatty acid (ω3FA) supplement were assessed on inflammatory and anti-inflammatory markers in gas station workers in a double-blind placebo-controlled clinical trial. Fifty-three men working in gas stations were treated with ω3FA ( n  = 29) or placebo ( n  = 24) for 60 days. C-reactive protein, interleukin-12 (IL-12), transforming growth factor β (TGF-β), interferon γ (IFN-γ), tumor necrosis factor α, IL-10, and IL-17 levels were measured by enzyme-linked immunosorbent assay method before and after the completion of the trial. The concentrations of IFN-γ and IL-17 were significantly decreased in ω3FA group compared with the placebo group ( P  < 0.001). Moreover, the levels of inhibitory cytokines including TGF-β and IL-10 significantly were increased in ω3FA group ( P  < 0.001). Overall, ω3FA nutritional supplementation can be useful in reducing inflammatory immune responses and maintaining immune tolerance in people with high exposure to inflammation-inducing factors. [Figure: see text].",2020,The concentrations of IFN-γ and IL-17 were significantly decreased in ω3FA group compared with the placebo group ( P  < 0.001).,"['Fifty-three men working in gas stations', 'Gas Station Workers', 'people with high exposure to inflammation-inducing factors']","['omega 3 fatty acid (ω3FA) supplement', 'placebo', 'Environmental exposure to diesel particulate matter and commercial gasoline', 'ω3FA', 'Placebo']","['inflammatory and anti-inflammatory markers', 'levels of inhibitory cytokines including TGF-β and IL-10', 'α, IL-10, and IL-17 levels', 'C-reactive protein, interleukin-12 (IL-12), transforming growth factor β (TGF-β), interferon γ (IFN-γ), tumor necrosis factor', 'concentrations of IFN-γ and IL-17']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0562311', 'cui_str': 'Petrol station'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0014412', 'cui_str': 'Environmental Exposure'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C0017113', 'cui_str': 'Gasoline'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0384648', 'cui_str': 'IL-17'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0040691', 'cui_str': 'Animal growth regulators, transforming growth factors'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",53.0,0.436733,The concentrations of IFN-γ and IL-17 were significantly decreased in ω3FA group compared with the placebo group ( P  < 0.001).,"[{'ForeName': 'Shoresh', 'Initials': 'S', 'LastName': 'Barkhordari', 'Affiliation': 'Student Research Committee, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Mirmosayyeb', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mansourian', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Hosseininasab', 'Affiliation': 'Department of Immunology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Ramezani', 'Affiliation': 'Student Research Committee, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Barzegar', 'Affiliation': 'Student Research Committee, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad Mehdi', 'Initials': 'MM', 'LastName': 'Amin', 'Affiliation': 'Environment Research Center, Research Institute for Primordial Prevention of Non-Communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Parinaz', 'Initials': 'P', 'LastName': 'Poursafa', 'Affiliation': 'Environment Research Center, Research Institute for Primordial Prevention of Non-Communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Esmaeil', 'Affiliation': 'Environment Research Center, Research Institute for Primordial Prevention of Non-Communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Kelishadi', 'Affiliation': 'Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research,['10.1089/jir.2019.0220']
371,31504461,Causal association between periodontitis and hypertension: evidence from Mendelian randomization and a randomized controlled trial of non-surgical periodontal therapy.,"AIMS


Inflammation is an important driver of hypertension. Periodontitis is a chronic inflammatory disease, which could provide a mechanism for pro-hypertensive immune activation, but evidence of a causal relationship in humans is scarce. We aimed to investigate the nature of the association between periodontitis and hypertension.
METHODS AND RESULTS


We performed a two-sample Mendelian randomization analysis in the ∼750 000 UK-Biobank/International Consortium of Blood Pressure-Genome-Wide Association Studies participants using single nucleotide polymorphisms (SNPs) in SIGLEC5, DEFA1A3, MTND1P5, and LOC107984137 loci GWAS-linked to periodontitis, to ascertain their effect on blood pressure (BP) estimates. This demonstrated a significant relationship between periodontitis-linked SNPs and BP phenotypes. We then performed a randomized intervention trial on the effects of treatment of periodontitis on BP. One hundred and one hypertensive patients with moderate/severe periodontitis were randomized to intensive periodontal treatment (IPT; sub- and supragingival scaling/chlorhexidine; n = 50) or control periodontal treatment (CPT; supragingival scaling; n = 51) with mean ambulatory 24-h (ABPM) systolic BP (SBP) as primary outcome. Intensive periodontal treatment improved periodontal status at 2 months, compared to CPT. This was accompanied by a substantial reduction in mean SBP in IPT compared to the CPT (mean difference of -11.1 mmHg; 95% CI 6.5-15.8; P < 0.001). Systolic BP reduction was correlated to periodontal status improvement. Diastolic BP and endothelial function (flow-mediated dilatation) were also improved by IPT. These cardiovascular changes were accompanied by reductions in circulating IFN-γ and IL-6 as well as activated (CD38+) and immunosenescent (CD57+CD28null) CD8+T cells, previously implicated in hypertension.
CONCLUSION


A causal relationship between periodontitis and BP was observed providing proof of concept for development of clinical trial in a large cohort of hypertensive patients. ClinicalTrials.gov: NCT02131922.",2019,"These cardiovascular changes were accompanied by reductions in circulating IFN-γ and IL-6 as well as activated (CD38+) and immunosenescent (CD57+CD28null) CD8+T cells, previously implicated in hypertension.
","['One hundred and one hypertensive patients with moderate/severe periodontitis', 'hypertensive patients', 'two-sample Mendelian randomization analysis in the ∼750\xa0000']",['intensive periodontal treatment (IPT; sub- and supragingival scaling/chlorhexidine; n\u2009=\u200950) or control periodontal treatment (CPT; supragingival scaling; n\u2009=\u200951) with mean ambulatory 24-h (ABPM) systolic BP (SBP'],"['Diastolic BP and endothelial function (flow-mediated dilatation', 'periodontal status', 'Systolic BP reduction', 'circulating IFN-γ and IL-6 as well as activated (CD38+) and immunosenescent (CD57+CD28null) CD8+T cells', 'blood pressure (BP) estimates']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C2718019', 'cui_str': 'Mendelian Randomization Analysis'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",,0.0845079,"These cardiovascular changes were accompanied by reductions in circulating IFN-γ and IL-6 as well as activated (CD38+) and immunosenescent (CD57+CD28null) CD8+T cells, previously implicated in hypertension.
","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Czesnikiewicz-Guzik', 'Affiliation': 'Department of Periodontology and Oral Sciences Research Group, University of Glasgow Dental School, Glasgow, UK.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Osmenda', 'Affiliation': 'Department of Internal and Agricultural Medicine, Jagiellonian University Medical College, 31-107, Krakow, Poland.'}, {'ForeName': 'Mateusz', 'Initials': 'M', 'LastName': 'Siedlinski', 'Affiliation': 'Department of Internal and Agricultural Medicine, Jagiellonian University Medical College, 31-107, Krakow, Poland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Nosalski', 'Affiliation': 'Department of Internal and Agricultural Medicine, Jagiellonian University Medical College, 31-107, Krakow, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Pelka', 'Affiliation': 'Department of Dental Prophylaxis and Experimental Dentistry, Jagiellonian University Medical College, Krakow, 31-107 Poland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Nowakowski', 'Affiliation': 'Department of Dental Prophylaxis and Experimental Dentistry, Jagiellonian University Medical College, Krakow, 31-107 Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Wilk', 'Affiliation': 'Department of Internal and Agricultural Medicine, Jagiellonian University Medical College, 31-107, Krakow, Poland.'}, {'ForeName': 'Tomasz P', 'Initials': 'TP', 'LastName': 'Mikolajczyk', 'Affiliation': 'Department of Internal and Agricultural Medicine, Jagiellonian University Medical College, 31-107, Krakow, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Schramm-Luc', 'Affiliation': 'Department of Internal and Agricultural Medicine, Jagiellonian University Medical College, 31-107, Krakow, Poland.'}, {'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Furtak', 'Affiliation': 'Department of Dental Prophylaxis and Experimental Dentistry, Jagiellonian University Medical College, Krakow, 31-107 Poland.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Matusik', 'Affiliation': 'Department of Internal and Agricultural Medicine, Jagiellonian University Medical College, 31-107, Krakow, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Koziol', 'Affiliation': 'Department of Internal and Agricultural Medicine, Jagiellonian University Medical College, 31-107, Krakow, Poland.'}, {'ForeName': 'Miroslaw', 'Initials': 'M', 'LastName': 'Drozdz', 'Affiliation': ""St. Anna's Hospital, 32-200 Miechow, Poland.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Munoz-Aguilera', 'Affiliation': 'Periodontology Unit, UCL Eastman Dental Institute, London, UK.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Tomaszewski', 'Affiliation': 'Division of Cardiovascular Sciences, School of Medical Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Evangelou', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Imperial College London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Caulfield', 'Affiliation': 'William Harvey Research Institute, NIHR Biomedical Research Centre at Barts, Queen Mary University of London, London, UK.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Grodzicki', 'Affiliation': 'Department of Internal Medicine and Gerontology, Jagiellonian University Medical College, 31-107 Krakow, Poland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': ""D'Aiuto"", 'Affiliation': 'Periodontology Unit, UCL Eastman Dental Institute, London, UK.'}, {'ForeName': 'Tomasz J', 'Initials': 'TJ', 'LastName': 'Guzik', 'Affiliation': 'Department of Internal and Agricultural Medicine, Jagiellonian University Medical College, 31-107, Krakow, Poland.'}]",European heart journal,['10.1093/eurheartj/ehz646']
372,30612463,"The effects of concurrent Coenzyme Q10, L-carnitine supplementation in migraine prophylaxis: A randomized, placebo-controlled, double-blind trial.","PURPOSE


The present study aimed to determine the effects of combined supplementation of Coenzyme Q10 with L-carnitine on mitochondrial metabolic disorders marker and migraine symptoms among migraine patients.
METHODS


A total of 56 men and women, between 20-40 years of age with migraine headache, participated in this randomized, double-blind, placebo-controlled, parallel study. The subjects were randomly assigned to receive either 30 mg/day Coenzyme Q10 and 500 mg/day L-carnitine at the same time and/or placebo tablets for 8 weeks. The measurements were completed at the beginning and end of the study. The primary outcome was severity of headache attacks. The secondary outcomes included duration, frequency of headache attacks, the headache diary results (HDR), and serum levels of lactate.
RESULTS


A significant reduction was obtained in serum levels of lactate (-2.28 mg/dl, 95% CI: -3.65, -0.90; p = 0.002), severity (-3.03, 95% CI: -3.65, -2.40; p ≤ 0.001), duration (-7.67, 95% CI: -11.47, -3.90; p ≤ 0.001), frequency (-5.42, 95% CI: -7.31, -3.53; p ≤ 0.001) and HDR (-103.03, 95% CI: -145.76, -60.29; p ≤ 0.001) after 8 weeks.
CONCLUSION


This double-blind parallel study provides evidences supporting the beneficial effects of Coenzyme Q10 and L-carnitine supplements on serum levels of lactate and migraine symptoms.
TRIAL REGISTRATION


IRCT20121216011763N21.",2019,"A significant reduction was obtained in serum levels of lactate (-2.28 mg/dl, 95% CI: -3.65, -0.90; p = 0.002), severity (-3.03, 95% CI: -3.65, -2.40; p ≤ 0.001), duration (-7.67, 95% CI:","['migraine patients', '56 men and women, between 20-40 years of age with migraine headache', 'migraine prophylaxis']","['concurrent Coenzyme Q10, L-carnitine supplementation', 'Coenzyme Q10 and L-carnitine supplements', 'placebo', 'Coenzyme Q10 with L-carnitine', '30\u2009mg/day Coenzyme Q10 and 500\u2009mg/day L-carnitine']","['severity of headache attacks', 'serum levels of lactate', 'duration, frequency of headache attacks, the headache diary results (HDR), and serum levels of lactate', 'frequency ', 'HDR', 'serum levels of lactate and migraine symptoms', 'mitochondrial metabolic disorders marker and migraine symptoms']","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1142085', 'cui_str': 'Migraine prophylaxis (procedure)'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0056077', 'cui_str': 'coenzyme Q10'}, {'cui': 'C0087163', 'cui_str': 'l-carnitine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025517', 'cui_str': 'Thesaurismosis'}]",56.0,0.67054,"A significant reduction was obtained in serum levels of lactate (-2.28 mg/dl, 95% CI: -3.65, -0.90; p = 0.002), severity (-3.03, 95% CI: -3.65, -2.40; p ≤ 0.001), duration (-7.67, 95% CI:","[{'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Hajihashemi', 'Affiliation': '1 Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Askari', 'Affiliation': '1 Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Khorvash', 'Affiliation': '3 Neuroscience Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Reza Maracy', 'Affiliation': '4 Department of Epidemiology and Biostatistics, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Nourian', 'Affiliation': '1 Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102418821661']
373,31549356,"Effect of Obesity on Asthma Severity in Urban School Children of Kanpur, India: An Analytical Cross-Sectional Study.","The prevalence of both Obesity and Asthma is increasing worldwide. Various epidemiological data has linked obesity with the development and severity of asthma in children. The aim of this study was to assess if any relationship exists between obesity and asthma in children. The study population included school children aged 5 to 18 years. A total of 320 asthma cases and 300 controls were included in our study. Association analysis of obesity and asthma based on epidemiological basis was measured. Out of 320 cases, 61 children were found to have moderate persistent asthma. Out of 61 moderate persistent asthma cases, 50 children were selected randomly and divided into two groups. Group I included 25 obese moderate persistent asthmatics and Group II included 25 non-obese moderate persistent asthmatics. Forced expiratory volume in one second (FEV 1 ), Forced vital capacity (FVC), Forced expiratory flow (FEF 25-75% ), Peak expiratory flow (PEF) were measured with spirometry and Peak expiratory flow meter. Statistical analysis was done by Odds ratio and p value. Out of 320 cases, 97 were obese and 223 were non-obese. Out of 300 controls, 46 were obese and 254 were non-obese. Exposure rate for cases and controls were 30.31% and 15.33% respectively. Odds ratio was 2.40. χ 2  value was 19.56 with p value < 0.05.FEV 1 , FVC, FEF 25-75%, PEF  for Group-1 were 66.3 ± 9.9, 63.5 ± 4.2, 54.2 ± 5.7, 67.4 ± 8.4 respectively and FEV 1 , FVC, FEF 25-75% , PEF for Group-2 were 74.07 ± 3.5, 77.4 ± 7.2, 60.1 ± 2.1, 71.6 ± 2.4 respectively and p values were < 0.001, < 0.001, < 0.001, < 0.05 respectively which is statistically significant. Children who are obese are more likely to develop severe asthma than those who were not obese.",2020,"χ 2  value was 19.56 with p value < 0.05.FEV 1 , FVC, FEF 25-75%, PEF  for Group-1 were 66.3 ± 9.9, 63.5 ± 4.2, 54.2 ± 5.7, 67.4 ± 8.4 respectively and FEV 1 , FVC, FEF 25-75% , PEF for Group-2 were 74.07 ± 3.5, 77.4 ± 7.2, 60.1 ± 2.1, 71.6 ± 2.4 respectively and p values were < 0.001, < 0.001, < 0.001, < 0.05 respectively which is statistically significant.","['Out of 320 cases, 61 children were found to have moderate persistent asthma', 'Out of 320 cases, 97 were obese and 223 were non-obese', 'Out of 300 controls, 46 were obese and 254 were non-obese', 'children', '25 obese moderate persistent asthmatics and Group II included 25 non-obese moderate persistent asthmatics', 'school children aged 5 to 18\xa0years', '320 asthma cases and 300 controls were included in our study', '61 moderate persistent asthma cases, 50 children', 'Urban School Children of Kanpur, India']",[],"['spirometry and Peak expiratory flow meter', 'Forced expiratory volume in one second (FEV 1 ), Forced vital capacity (FVC), Forced expiratory flow (FEF 25-75% ), Peak expiratory flow (PEF', 'Exposure rate']","[{'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1960047', 'cui_str': 'Moderate persistent asthma (disorder)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0260267', 'cui_str': 'School child (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]",[],"[{'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C3804964', 'cui_str': 'Forced expiratory flow'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",61.0,0.0334171,"χ 2  value was 19.56 with p value < 0.05.FEV 1 , FVC, FEF 25-75%, PEF  for Group-1 were 66.3 ± 9.9, 63.5 ± 4.2, 54.2 ± 5.7, 67.4 ± 8.4 respectively and FEV 1 , FVC, FEF 25-75% , PEF for Group-2 were 74.07 ± 3.5, 77.4 ± 7.2, 60.1 ± 2.1, 71.6 ± 2.4 respectively and p values were < 0.001, < 0.001, < 0.001, < 0.05 respectively which is statistically significant.","[{'ForeName': 'S P Senthil', 'Initials': 'SPS', 'LastName': 'Kumar', 'Affiliation': 'Columbia Asia Hospital, Whitefield, Bengaluru, Karnataka, India. drsenthilsp@yahoo.co.in.'}, {'ForeName': 'Shalu', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Femiint Health Care, Whitefield, Bengaluru, Karnataka, India.'}]",Journal of community health,['10.1007/s10900-019-00749-z']
374,32085753,"Adjuvant chemotherapy could not bring survival benefit to HR-positive, HER2-negative, pT1b-c/N0-1/M0 invasive lobular carcinoma of the breast: a propensity score matching study based on SEER database.","BACKGROUND


The benefit of adjuvant chemotherapy in invasive lobular carcinoma (ILC) is still unclear. The objective of the current study was to elucidate the effectiveness of adjuvant chemotherapy in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, pT1b-c/N0-1/M0 ILC.
METHODS


Based on Surveillance, Epidemiology, and End-Results (SEER) database, we identified original 12,334 HR-positive, HER2-negative, pT1b-c/N0-1/M0 ILC patients, who were then divided into adjuvant chemotherapy group and control group. End-points were overall survival (OS) and breast cancer-specific mortality (BCSM). Aiming to minimize the selection bias of baseline characteristics, Propensity Score Matching (PSM) method was used.
RESULTS


In a total of 12,334 patients with HR-positive, HER2-negative, pT1b-c/N0-1/M0 ILC, 1785 patients (14.5%) were allocated into adjuvant chemotherapy group and 10,549 (85.5%) into control group. Used PSM, the 1785 patients in adjuvant chemotherapy group matched to the 1785 patients in control group. By Kaplan-Meier survival analyses, we observed no beneficial effect of adjuvant chemotherapy on OS in both original samples (P = 0.639) and matched samples (P = 0.962), however, ineffective or even contrary results of adjuvant chemotherapy on BCSM both in original samples (P = 0.001) and in matched samples (P = 0.002). In both original and matched multivariate Cox models, we observed ineffectiveness of adjuvant chemotherapy on OS (hazard ratio (HR) for overall survival = 0.82, 95% confidence interval (CI) [0.62-1.09]; P = 0.172 and HR = 0.90, 95%CI [0.65-1.26]; P = 0.553, respectively), unexpectedly promoting effect of adjuvant chemotherapy on BCSM (HR = 2.33, 95%CI [1.47-3.67]; P = 0.001 and HR = 2.41, 95%CI [1.32-4.39]; P = 0.004, respectively). Standard surgery was beneficial to the survival of patients. Lymph node metastasis was detrimental to survival and radiotherapy brought survival benefit in original samples, but two issues had unobvious effect in matched samples.
CONCLUSION


In this study, adjuvant chemotherapy did not improve survival for patients with HR-positive, HER2-negative pT1b-c/N0-1/M0 ILC.",2020,"By Kaplan-Meier survival analyses, we observed no beneficial effect of adjuvant chemotherapy on OS in both original samples (P = 0.639) and matched samples (P = 0.962), however, ineffective or even contrary results of adjuvant chemotherapy on BCSM both in original samples (P = 0.001) and in matched samples (P = 0.002).","['1785 patients in adjuvant chemotherapy group matched to the 1785 patients in control group', 'invasive lobular carcinoma (ILC', '12,334 patients with HR-positive, HER2-negative, pT1b-c/N0-1/M0 ILC, 1785 patients (14.5']","['adjuvant chemotherapy', 'Adjuvant chemotherapy']","['survival', 'overall survival (OS) and breast cancer-specific mortality (BCSM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0206692', 'cui_str': 'Carcinoma, Lobular'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",12334.0,0.2242,"By Kaplan-Meier survival analyses, we observed no beneficial effect of adjuvant chemotherapy on OS in both original samples (P = 0.639) and matched samples (P = 0.962), however, ineffective or even contrary results of adjuvant chemotherapy on BCSM both in original samples (P = 0.001) and in matched samples (P = 0.002).","[{'ForeName': 'Guangfu', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': ""Department of Breast Surgery, Huangpu Branch, Shanghai Ninth People's Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Guangxia', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': ""Department of Pathology, Binzhong People's Hospital, Affiliated to First Shandong Medical University, Binzhong, China.""}, {'ForeName': 'Chengjiao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychological Measurement, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Department of Breast Surgery, Yangpu Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Shan', 'Affiliation': ""Department of Breast Surgery, Huangpu Branch, Shanghai Ninth People's Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yanmin', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ""Department of Breast Surgery, Huangpu Branch, Shanghai Ninth People's Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yongwei', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Breast Surgery, Huangpu Branch, Shanghai Ninth People's Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Ruijie', 'Initials': 'R', 'LastName': 'Niu', 'Affiliation': ""Department of Breast Surgery, Huangpu Branch, Shanghai Ninth People's Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Ye', 'Affiliation': ""Department of Breast Surgery, Huangpu Branch, Shanghai Ninth People's Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Department of Breast Surgery, Huangpu Branch, Shanghai Ninth People's Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China. wangcheng1212@hotmail.com.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Breast Surgery, Yangpu Hospital, Tongji University School of Medicine, Shanghai, China. xucheng@live.cn.'}]",BMC cancer,['10.1186/s12885-020-6614-0']
375,31732098,Efficacy of Nivolumab plus Ipilimumab According to Number of IMDC Risk Factors in CheckMate 214.,"In the randomized, open-label, phase 3 CheckMate 214 trial, nivolumab plus ipilimumab (nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 wk for four doses, then nivolumab 3 mg/kg every 2 wk) had superior efficacy over sunitinib (50 mg once daily, 4 wk on, 2 wk off) in patients with untreated International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) intermediate- or poor-risk advanced renal cell carcinoma; the benefits were sustained through extended follow-up. To better characterize the association between outcomes and IMDC risk in CheckMate 214, we completed a post hoc analysis (n = 1051) of efficacy by the number of IMDC risk factors. The investigator-assessed objective response rate (ORR), overall survival (OS), and investigator-assessed progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors v1.1 were evaluated. ORR with nivolumab plus ipilimumab was consistent across zero to six IMDC risk factors, whereas with sunitinib it decreased with increasing number of risk factors. Benefits of nivolumab plus ipilimumab over sunitinib in terms of ORR (40-44% vs 16-38%), OS (hazard ratio [HR] 0.50-0.72), and PFS (HR 0.44-0.86) were consistently observed in subgroups with one, two, three, or four to six IMDC risk factors (p < 0.05 for treatment × no. of risk factors interaction). These results demonstrate the benefit of first-line nivolumab plus ipilimumab over sunitinib across all intermediate-risk and poor-risk groups, regardless of the number of IMDC risk factors. PATIENT SUMMARY: This report from the CheckMate 214 study describes a consistent efficacy benefit with first-line nivolumab plus ipilimumab over first-line sunitinib in all groups of patients with intermediate-risk or poor-risk advanced renal cell carcinoma, regardless of the number of risk factors they had before starting treatment. We conclude that there is a benefit of first-line treatment with nivolumab plus ipilimumab for all intermediate-risk patients, including those with one or two risk factors, and for all poor-risk patients, independent of the number of risk factors.",2020,"ORR with nivolumab plus ipilimumab was consistent across zero to six IMDC risk factors, whereas with sunitinib it decreased with increasing number of risk factors.","['patients with untreated International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) intermediate- or poor-risk advanced renal cell carcinoma', 'patients with intermediate-risk or poor-risk advanced renal cell carcinoma, regardless of the number of risk factors they had before starting treatment']","['nivolumab plus ipilimumab (nivolumab 3\u2009mg/kg plus ipilimumab', 'first-line nivolumab plus ipilimumab', 'nivolumab plus ipilimumab', 'sunitinib', 'Nivolumab plus Ipilimumab']","['objective response rate (ORR), overall survival (OS), and investigator-assessed progression-free survival (PFS', 'ORR', 'number of risk factors', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",214.0,0.038159,"ORR with nivolumab plus ipilimumab was consistent across zero to six IMDC risk factors, whereas with sunitinib it decreased with increasing number of risk factors.","[{'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Gustave Roussy, Villejuif, France. Electronic address: escudier@gustaveroussy.fr.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'Department of Internal Medicine, University of Pavia, Pavia, Italy; Division of Translational Oncology, IRCCS Istituti Clinici Scientifici Maugeri, Pavia, Italy.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Niigata University, Niigata, Japan.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Maurer', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'M Brent', 'Initials': 'MB', 'LastName': 'McHenry', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA.'}]",European urology,['10.1016/j.eururo.2019.10.025']
376,30854880,Calcitonin-gene related peptide and disease activity in cluster headache.,"OBJECTIVE


To investigate the role of calcitonin gene-related peptide, pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal polypeptide in cluster headache, we measured these vasoactive peptides interictally and during experimentally induced cluster headache attacks.
METHODS


We included patients with episodic cluster headache in an active phase (n = 9), episodic cluster headache patients in remission (n = 9) and patients with chronic cluster headache (n = 13). Cluster headache attacks were induced by infusion of calcitonin gene-related peptide (1.5 µg/min) in a randomized, double-blind, placebo controlled, two-way cross-over study. At baseline, we collected interictal blood samples from all patients and during 11 calcitonin gene-related peptide-induced cluster headache attacks.
RESULTS


At baseline, episodic cluster headache patients in remission had higher plasma levels of calcitonin gene-related peptide, 100.6 ± 36.3 pmol/l, compared to chronic cluster headache patients, 65.9 ± 30.5 pmol/l, ( p = 0.011). Episodic cluster headache patients in active phase had higher PACAP38 levels, 4.0 ± 0.8 pmol/l, compared to chronic cluster headache patients, 3.3 ± 0.7 pmol/l, ( p = 0.033). Baseline levels of vasoactive intestinal polypeptide did not differ between cluster headache groups. We found no attack-related increase in calcitonin gene-related peptide, PACAP38 or vasoactive intestinal polypeptide levels during calcitonin gene-related peptide-induced cluster headache attacks.
CONCLUSIONS


This study suggests that cluster headache disease activity is associated with alterations of calcitonin gene-related peptide expression. Future studies should investigate the potential of using calcitonin gene-related peptide measurements in monitoring of disease state and predicting response to preventive treatments, including response to anti-calcitonin gene-related peptide monoclonal antibodies.",2019,"We found no attack-related increase in calcitonin gene-related peptide, PACAP38 or vasoactive intestinal polypeptide levels during calcitonin gene-related peptide-induced cluster headache attacks.
","['Episodic cluster headache patients', 'patients with episodic cluster headache in an active phase (n\u2009=\u20099), episodic cluster headache patients in remission (n\u2009=\u20099) and patients with chronic cluster headache (n\u2009=\u200913']","['Calcitonin', 'placebo']","['Cluster headache attacks', 'Baseline levels of vasoactive intestinal polypeptide']","[{'cui': 'C0393739', 'cui_str': 'Episodic Cluster Headache'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0009088', 'cui_str': 'Neuralgic Migraine'}]","[{'cui': 'C0073994', 'cui_str': 'calcitonin (salmon synthetic)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0009088', 'cui_str': 'Neuralgic Migraine'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0042395', 'cui_str': 'VIP'}]",,0.059235,"We found no attack-related increase in calcitonin gene-related peptide, PACAP38 or vasoactive intestinal polypeptide levels during calcitonin gene-related peptide-induced cluster headache attacks.
","[{'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Snoer', 'Affiliation': '1 Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne Luise H', 'Initials': 'ALH', 'LastName': 'Vollesen', 'Affiliation': '1 Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rasmus P', 'Initials': 'RP', 'LastName': 'Beske', 'Affiliation': '1 Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': '1 Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hoffmann', 'Affiliation': ""2 Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Fahrenkrug', 'Affiliation': '3 Department of Clinical Biochemistry, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niklas Rye', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': '4 Department of Clinical Biochemistry, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Martinussen', 'Affiliation': '6 Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rigmor H', 'Initials': 'RH', 'LastName': 'Jensen', 'Affiliation': '1 Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': '1 Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419837154']
377,31501120,Addressing clinical equipoise for hearing devices: the qualitative COACH (q-COACH) study protocol for Australian stakeholder involvement in the design of a randomised controlled trial.,"INTRODUCTION


Hearing loss is a common chronic problem which can be effectively managed with hearing devices. At present, only a limited number of people with hearing loss use hearing aids (HAs) and cochlear implants (CIs) to improve hearing and sound quality and enhance quality of life. Clinical equipoise, by which we mean healthcare professional uncertainty about which treatment options are the most efficacious due to the lack of evidence-based information, can lead to inconsistent and poorly informed referral processes for hearing devices.A randomised controlled trial (RCT) that offers high-quality, generalisable information is needed to clarify which hearing device (HA or CI) is more suitable for different degrees of hearing loss and for which kinds of patients. Qualitative research can improve this RCT, by gathering the information on patient and provider perspectives, attitudes and values, which can inform design, conduct and information dissemination, either during preparatory stages of an intervention, or as a fully integrated methodology. The Comparison of Outcomes with hearing Aids and Cochlear implants in adults with moderately severe-to-profound bilateral sensorineural Hearing loss (COACH) study is being planned as an RCT with a qualitative arm (the qualitative COACH study, q-COACH), acting as a pretrial intervention examining views of HAs, CIs, equipoise and the impetus for an RCT of this nature.
METHODS AND ANALYSIS


The q-COACH study involves semistructured interviews and a demographic questionnaire which will be collected from four participant cohorts: General Practitioners (GPs) and Ear, Nose and Throat Surgeons (ENTs); audiologists; adult HA users and their support networks. Data will be analysed thematically and through descriptive statistics.
ETHICS AND DISSEMINATION


Macquarie University Human Research Ethics Committee, Australia, granted ethical approval (no. 5201833514848). Peer-reviewed journal articles, research conferences and a final report will present study findings.",2019,"A randomised controlled trial (RCT) that offers high-quality, generalisable information is needed to clarify which hearing device (HA or CI) is more suitable for different degrees of hearing loss and for which kinds of patients.","['four participant cohorts: General Practitioners (GPs) and Ear, Nose and Throat Surgeons (ENTs); audiologists; adult HA users and their support networks', 'adults with moderately severe-to-profound bilateral sensorineural Hearing loss (COACH']","['hearing device (HA or CI', 'hearing Aids and Cochlear implants']",['hearing and sound quality and enhance quality of life'],"[{'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0586894', 'cui_str': 'Ear, nose and throat surgeon (occupation)'}, {'cui': 'C0175838', 'cui_str': 'Audiologist'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439808', 'cui_str': 'Profundis'}, {'cui': 'C0452138', 'cui_str': 'Sensorineural hearing loss, bilateral (disorder)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0009199', 'cui_str': 'Auditory Prosthesis'}]","[{'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0034380'}]",,0.181834,"A randomised controlled trial (RCT) that offers high-quality, generalisable information is needed to clarify which hearing device (HA or CI) is more suitable for different degrees of hearing loss and for which kinds of patients.","[{'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Rapport', 'Affiliation': 'Australian Institute of Health Innovation, Faculty of Medicine and Health Sciences, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Auton', 'Affiliation': 'Australian Institute of Health Innovation, Faculty of Medicine and Health Sciences, Macquarie University, Sydney, New South Wales, Australia emilie.auton@mq.edu.au.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Warren', 'Affiliation': 'Cochlear Ltd, North Ryde, New South Wales, Australia.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Braithwaite', 'Affiliation': 'Australian Institute of Health Innovation, Faculty of Medicine and Health Sciences, Macquarie University, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-030100']
378,32182123,The effect of acute dual SGLT1/SGLT2 inhibition on incretin release and glucose metabolism after gastric bypass surgery.,"Enhanced meal-related enteroendocrine secretion, particularly of glucagon-like peptide-1 (GLP-1), contributes to weight-loss and improved glycemia after Roux-en-Y gastric bypass (RYGB). Dietary glucose drives GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) secretion postoperatively. Understanding how glucose triggers incretin secretion following RYGB could lead to new treatments of diabetes and obesity. In vitro, incretin release depends on glucose absorption via sodium-glucose cotransporter 1 (SGLT1). We investigated the importance of SGLT1/SGLT2 for enteropancreatic hormone concentrations and glucose metabolism after RYGB in a randomized, controlled, crossover study. Ten RYGB-operated patients ingested 50 g of oral glucose with and without acute pretreatment with 600 mg of the SGLT1/SGLT2-inhibitor canagliflozin. Paracetamol and 3- O -methyl-d-glucopyranose (3-OMG) were added to the glucose drink to evaluate rates of intestinal entry and absorption of glucose, respectively. Blood samples were collected for 4 h. The primary outcome was 4-h plasma GLP-1 (incremental area-under the curve, iAUC). Secondary outcomes included glucose, GIP, insulin, and glucagon. Canagliflozin delayed glucose absorption (time-to-peak 3-OMG: 50 vs. 132 min,  P  < 0.01) but did not reduce iAUC GLP-1 (6,067 vs. 7,273·min·pmol -1 ·L -1 ,  P  = 0.23), although peak GLP-1 concentrations were lowered (-28%,  P  = 0.03). Canagliflozin reduced GIP (iAUC -28%,  P  = 0.01; peak concentrations -57%,  P  < 0.01), insulin, and glucose excursions, whereas plasma glucagon (AUC 3,216 vs. 4,160 min·pmol·L -1 ,  P  = 0.02) and amino acids were increased. In conclusion, acute SGLT1/SGLT2-inhibition during glucose ingestion did not reduce 4-h plasma GLP-1 responses in RYGB-patients but attenuated the early rise in GLP-1, GIP, and insulin, whereas late glucagon concentrations were increased. The results suggest that SGLT1-mediated glucose absorption contributes to incretin hormone secretion after RYGB.",2020,"Canagliflozin reduced GIP (iAUC -28%, p=0.01; peak concentrations -57%, p<0.01), insulin and glucose excursions, whereas plasma glucagon (AUC 3216 vs. 4160 min∙pmol/l, p=0.02) and amino acids were increased.",['gastric bypass surgery'],"['acute dual SGLT1/SGLT2 inhibition', 'oral glucose ± acute pretreatment with 600 mg of the SGLT1/SGLT2-inhibitor canagliflozin', 'Paracetamol and 3-O-methyl-D-glucopyranose (3-OMG', 'SGLT1/SGLT2']","['4-h plasma GLP-1 (incremental area-under-the-curve, iAUC', '4-h plasma GLP-1 responses', 'peak GLP-1 concentrations', 'Blood samples', 'incretin release and glucose metabolism', 'glucose absorption via sodium-glucose cotransporter-1 (SGLT1', 'Canagliflozin delayed glucose absorption', 'iAUC GLP-1', 'insulin and glucose excursions', 'plasma glucagon', 'late glucagon concentrations', 'Canagliflozin reduced GIP', 'weight-loss and improved glycemia', 'glucose, GIP, insulin and glucagon', 'amino acids']","[{'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0248805', 'cui_str': 'Sodium-Glucose Transporter 1'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}]",10.0,0.0401356,"Canagliflozin reduced GIP (iAUC -28%, p=0.01; peak concentrations -57%, p<0.01), insulin and glucose excursions, whereas plasma glucagon (AUC 3216 vs. 4160 min∙pmol/l, p=0.02) and amino acids were increased.","[{'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Martinussen', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Veedfald', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Dirksen', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Kirstine N', 'Initials': 'KN', 'LastName': 'Bojsen-Møller', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Svane', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'van Hall', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Viggo B', 'Initials': 'VB', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Surgical Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Fenger', 'Affiliation': 'Department of Clinical Biochemistry, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00023.2020']
379,31501124,A single-centre investigator-blinded randomised parallel group clinical trial to investigate the effect of probiotic strains  Streptococcus salivarius  M18 and  Lactobacillus acidophilus  on gingival health of paediatric patients undergoing treatment with fixed orthodontic appliances: study protocol.,"BACKGROUND


There is limited data on the beneficial effects of probiotics on the gingival health of patients undergoing treatment with fixed orthodontic appliances. This study aims to compare the effect of probiotic tablets combined with regular oral hygiene versus regular oral hygiene alone on gingival status in these patients. The effect of probiotic intake on plaque formation and salivary microbiome composition will be also assessed.
METHODS AND ANALYSIS


This is a 3 month single-centre, single blind (clinical and laboratory examiners), parallel group randomised controlled two arm superiority trial. Fifty paediatric patients attending the Postgraduate Orthodontic Clinic at the Hamdan Bin Mohammed College of Dental Medicine (HBMCDM), Mohammed Bin Rashid University of Medicine and Health Sciences (MBRU), Dubai, United Arab Emirates, who meet the eligibility criteria will be recruited. Block randomisation with 1:1 allocation and concealment of allocation will be carried out. The treatment group will receive probiotic tablets containing  Streptococcus salivarius  M18 and  Lactobacillus acidophilus  together with regular oral hygiene versus the control group on regular oral hygiene alone. Clinical examination and collection of saliva for microbiome assay will be carried out at baseline and end of study. Self-reporting by patients will be used to document acceptability and adverse effects. Statistically significant decrease in gingival bleeding on probing in the treatment group will be classified as primary outcome of treatment success. Statistically significant reduction in Plaque Index, Gingival Index and shift in the composition of the oral microbiome in favour of beneficial bacteria are secondary outcomes indicative of efficacy of probiotic intake.
ETHICS AND DISSEMINATION


Ethical approval for the study has been granted by the HBMCDM, MBRU, Institutional Review Board (Reference #: MBRU-IRB-2018-015). Study findings will be disseminated via publication in peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ISRCTN95085398.",2019,"Statistically significant reduction in Plaque Index, Gingival Index and shift in the composition of the oral microbiome in favour of beneficial bacteria are secondary outcomes indicative of efficacy of probiotic intake.
","['paediatric patients undergoing treatment with fixed orthodontic appliances', 'patients undergoing treatment with fixed orthodontic appliances', 'Fifty paediatric patients attending the Postgraduate Orthodontic Clinic at the Hamdan Bin Mohammed College of Dental Medicine (HBMCDM), Mohammed Bin Rashid University of Medicine and Health Sciences (MBRU), Dubai, United Arab Emirates, who meet the eligibility criteria will be recruited']","['probiotics', 'probiotic intake', 'probiotic strains  Streptococcus salivarius  M18 and  Lactobacillus acidophilus', 'probiotic tablets combined with regular oral hygiene versus regular oral hygiene alone', 'probiotic tablets containing  Streptococcus salivarius  M18 and  Lactobacillus acidophilus  together with regular oral hygiene versus the control group on regular oral hygiene alone']","['gingival health', 'gingival status', 'Plaque Index, Gingival Index', 'gingival bleeding', 'plaque formation and salivary microbiome composition']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441421', 'cui_str': 'Permanent Retainer'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282540', 'cui_str': 'Arabs'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0318179', 'cui_str': 'Streptococcus salivarius'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1272386', 'cui_str': 'Mouth care management'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0017565', 'cui_str': 'Gingival Hemorrhage'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",50.0,0.303522,"Statistically significant reduction in Plaque Index, Gingival Index and shift in the composition of the oral microbiome in favour of beneficial bacteria are secondary outcomes indicative of efficacy of probiotic intake.
","[{'ForeName': 'Eleftherios G', 'Initials': 'EG', 'LastName': 'Kaklamanos', 'Affiliation': 'Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, United Arab Emirates.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Nassar', 'Affiliation': 'College of Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, United Arab Emirates.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Kalfas', 'Affiliation': 'School of Dentistry, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'Al Halabi', 'Affiliation': 'Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, United Arab Emirates.'}, {'ForeName': 'Mawlood', 'Initials': 'M', 'LastName': 'Kowash', 'Affiliation': 'Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, United Arab Emirates.'}, {'ForeName': 'Haifa', 'Initials': 'H', 'LastName': 'Hannawi', 'Affiliation': 'Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, United Arab Emirates.'}, {'ForeName': 'Iyad', 'Initials': 'I', 'LastName': 'Hussein', 'Affiliation': 'Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, United Arab Emirates.'}, {'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'Salami', 'Affiliation': 'Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, United Arab Emirates.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, United Arab Emirates.'}, {'ForeName': 'Abiola C', 'Initials': 'AC', 'LastName': 'Senok', 'Affiliation': 'College of Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, United Arab Emirates abiola.senok@mbru.ac.ae.'}]",BMJ open,['10.1136/bmjopen-2019-030638']
380,31501133,Protocol for a multisite randomised trial of Hand-Arm Bimanual Intensive Training Including Lower Extremity training for children with bilateral cerebral palsy: HABIT-ILE Australia.,"INTRODUCTION


Children with bilateral cerebral palsy often experience difficulties with posture, gross motor function and manual ability, impacting independence in daily life activities, participation and quality of life (QOL). Hand-Arm Bimanual Intensive Training Including Lower Extremity (HABIT-ILE) is a novel intensive motor intervention integrating upper and lower extremity training. This study aimed to compare HABIT-ILE to usual care in a large randomised controlled trial (RCT) in terms of gross motor function, manual ability, goal attainment, walking endurance, mobility, self-care and QOL. A within-trial cost-utility analysis will be conducted to synthesise costs and benefits of HABIT-ILE compared with usual care.
METHODS AND ANALYSIS


126 children with bilateral cerebral palsy aged 6-16 years will be recruited across three sites in Australia. Children will be stratified by site and Gross Motor Function Classification System and randomised using concealed allocation to either receiving HABIT-ILE immediately or being waitlisted for 26 weeks. HABIT-ILE will be delivered in groups of 8-12 children, for 6.5 hours per day for 10 days (total 65 hours, 2 weeks). Outcomes will be assessed at baseline, immediately following intervention, and then retention of effects will be tested at 26 weeks. Primary outcomes will be the Gross Motor Function Measure and ABILHAND-Kids. Secondary outcomes will be brain structural integrity, walking endurance, bimanual hand performance, self-care, mobility, performance and satisfaction with individualised goals, and QOL. Analyses will follow standard principles for RCTs using two-group comparisons on all participants on an intention-to-treat basis. Comparisons between groups for primary and secondary outcomes will be conducted using regression models.
ETHICS AND DISSEMINATION


Ethics approval has been granted by the Medical Research Ethics Committee of Children's Health Queensland Hospital and the Health Service Human Research Ethics Committee (HREC/17/QRCH/282) of The University of Queensland (2018000017/HREC/17/QRCH/2820), and The Cerebral Palsy Alliance Ethics Committee (2018_04_01/HREC/17/QRCH/282).
TRIAL REGISTRATION NUMBER


ACTRN12618000164291.",2019,"Secondary outcomes will be brain structural integrity, walking endurance, bimanual hand performance, self-care, mobility, performance and satisfaction with individualised goals, and QOL.","['Children with bilateral cerebral palsy', 'children with bilateral cerebral palsy: HABIT-ILE Australia', '126 children with bilateral cerebral palsy aged 6-16 years will be recruited across three sites in Australia']","['Hand-Arm Bimanual Intensive Training Including Lower Extremity training', 'HABIT-ILE']","['Gross Motor Function Measure and ABILHAND-Kids', 'daily life activities, participation and quality of life (QOL', 'brain structural integrity, walking endurance, bimanual hand performance, self-care, mobility, performance and satisfaction with individualised goals, and QOL', 'gross motor function, manual ability, goal attainment, walking endurance, mobility, self-care and QOL']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3838784', 'cui_str': 'Bilateral spastic cerebral palsy'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]","[{'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",126.0,0.201066,"Secondary outcomes will be brain structural integrity, walking endurance, bimanual hand performance, self-care, mobility, performance and satisfaction with individualised goals, and QOL.","[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Sakzewski', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, The Faculty of Medicine, University of Queensland, South Brisbane, Queensland, Australia l.sakzewski1@uq.edu.au.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Bleyenheuft', 'Affiliation': 'Institute of Neuroscience, Université Catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Roslyn N', 'Initials': 'RN', 'LastName': 'Boyd', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, The Faculty of Medicine, University of Queensland, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Iona', 'Initials': 'I', 'LastName': 'Novak', 'Affiliation': 'Cerebral Palsy Alliance, Brookvale, New South Wales, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Elliott', 'Affiliation': 'School of Occupational Therapy and Social Work, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Reedman', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, The Faculty of Medicine, University of Queensland, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Morgan', 'Affiliation': 'Cerebral Palsy Alliance, Brookvale, New South Wales, Australia.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Pannek', 'Affiliation': 'CSIRO Health and Biosecurity, CSIRO Australian e-Health Research Centre, Herston, Queensland, Australia.'}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Fripp', 'Affiliation': 'CSIRO Health and Biosecurity, CSIRO Australian e-Health Research Centre, Herston, Queensland, Australia.'}, {'ForeName': 'Prue', 'Initials': 'P', 'LastName': 'Golland', 'Affiliation': 'Cerebral Palsy Alliance, Brookvale, New South Wales, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rowell', 'Affiliation': 'Faculty of Business, Economics and Law, University of Queensland, Wooloongabba, Queensland, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Chatfield', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, The Faculty of Medicine, University of Queensland, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Robert Stuart', 'Initials': 'RS', 'LastName': 'Ware', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-032194']
381,32161685,Integrated Chinese and Western Medicine for Acute Guillain-barré Syndrome Treatment.,"Introduction


Guillain-Barré syndrome (GBS) is a worldwide demyelinating polyradiculopathy and polyneuropathy. Currently, there is no specific drug for GBS, and established treatment is generally based on immune-modulating treatment with plasma exchange or intravenous immunoglobulin in combination with supportive care. This study aimed to investigate the efficiency of integrated Chinese and Western medicine for acute GBS treatment.
Methods


We enrolled 73 subjects, and randomly divided them into two groups: 35 cases in the traditional Chinese medicine (TCM) group, and 28 in the Control group. The Control group was treated with the common Western medicine for one month; and the TCM group was administrated with one month of common treatment combined with TCM medication.
Results


Compared to the controls, TCM significantly enhanced the treatment efficiency in symptom expression, including the TCM syndrome score, the activity of daily living score, Hughes functional score and sensory dysfunction assessment. The total effective rate of the TCM group was 94.29%, significantly better than controls (78.59%). Moreover, TCM provide better improvement in motor nerve conduction functions (distal motor latency and motor conduction velocity) and sensory nerve conduction functions (sensory conduction velocity and sensory nerve action potential) in median nerve, ulnar nerve, and common fibular nerve.
Conclusion


When combined with TCM administration, the GBS treatment could acquire better outcomes.",2020,"Moreover, TCM provide better improvement in motor nerve conduction functions (distal motor latency and motor conduction velocity) and sensory nerve conduction functions (sensory conduction velocity and sensory nerve action potential) in median nerve, ulnar nerve, and common fibular nerve.
",['73 subjects'],"['TCM medication', 'Introduction\n\n\nGuillain-Barré syndrome (GBS', 'Integrated Chinese and Western Medicine', 'TCM', 'traditional Chinese medicine (TCM', 'integrated Chinese and Western medicine']","['TCM syndrome score, the activity of daily living score, Hughes functional score and sensory dysfunction assessment', 'motor nerve conduction functions (distal motor latency and motor conduction velocity) and sensory nerve conduction functions (sensory conduction velocity and sensory nerve action potential) in median nerve, ulnar nerve, and common fibular nerve', 'total effective rate']",[],"[{'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0018378', 'cui_str': 'Landry-Guillain-Barre Syndrome'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}]","[{'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0027788', 'cui_str': 'Nerve Conduction'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber, function (observable entity)'}, {'cui': 'C0522219', 'cui_str': 'Sensory potential, function (observable entity)'}, {'cui': 'C0025058', 'cui_str': 'Median Nerve'}, {'cui': 'C0041602', 'cui_str': 'Ulnar Nerve'}, {'cui': 'C0031173', 'cui_str': 'Structure of common peroneal nerve'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",73.0,0.0267458,"Moreover, TCM provide better improvement in motor nerve conduction functions (distal motor latency and motor conduction velocity) and sensory nerve conduction functions (sensory conduction velocity and sensory nerve action potential) in median nerve, ulnar nerve, and common fibular nerve.
","[{'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Shanghai Dunlu Biomedical Technology Co., Ltd. Shanghai, China.'}, {'ForeName': 'Xiumin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'The Second Hospital of Hebei Medical University, Shijiazhuang, China.'}]",Translational neuroscience,['10.1515/tnsci-2020-0007']
382,31608930,Ghrelin Does Not Directly Stimulate Secretion of Glucagon-like Peptide-1.,"CONTEXT


The gastrointestinal hormone ghrelin stimulates growth hormone secretion and appetite, but recent studies indicate that ghrelin also stimulates the secretion of the appetite-inhibiting and insulinotropic hormone glucagon-like peptide-1 (GLP-1).
OBJECTIVE


To investigate the putative effect of ghrelin on GLP-1 secretion in vivo and in vitro.
SUBJECTS AND METHODS


A randomized placebo-controlled crossover study was performed in eight hypopituitary subjects. Ghrelin or saline was infused intravenously (1 pmol/min × kg) after collection of baseline sample (0 min), and blood was subsequently collected at time 30, 60, 90, and 120 minutes. Mouse small intestine was perfused (n = 6) and GLP-1 output from perfused mouse small intestine was investigated in response to vascular ghrelin administration in the presence and absence of a simultaneous luminal glucose stimulus. Ghrelin receptor expression was quantified in human (n = 11) and mouse L-cells (n = 3) by RNA sequencing and RT-qPCR, respectively.
RESULTS


Ghrelin did not affect GLP-1 secretion in humans (area under the curve [AUC; 0-120 min]: ghrelin infusion = 1.37 ± 0.05 min × nmol vs. saline infusion = 1.40 ± 0.06 min × nmol [P = 0.63]), but induced peripheral insulin resistance. Likewise, ghrelin did not stimulate GLP-1 secretion from the perfused mouse small intestine model (mean outputs during baseline/ghrelin infusion = 19.3 ± 1.6/25.5 ± 2.0 fmol/min, n = 6, P = 0.16), whereas glucose-dependent insulinotropic polypeptide administration, used as a positive control, doubled GLP-1 secretion (P < 0.001). Intraluminal glucose increased GLP-1 secretion by 4-fold (P < 0.001), which was not potentiated by ghrelin. Finally, gene expression of the ghrelin receptor was undetectable in mouse L-cells and marginal in human L-cells.
CONCLUSIONS


Ghrelin does not interact directly with the L-cell and does not directly affect GLP-1 secretion.",2020,Intra-luminal glucose increased GLP-1 secretion by 4-fold (P<0.001) which was not potentiated by ghrelin.,['eight hypopituitary subjects'],"['placebo', 'Ghrelin or saline']","['Ghrelin receptor expression', 'GLP-1 secretion', 'peripheral insulin resistance']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0391690', 'cui_str': 'GHSR Protein'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]",,0.090868,Intra-luminal glucose increased GLP-1 secretion by 4-fold (P<0.001) which was not potentiated by ghrelin.,"[{'ForeName': 'Sara Lind', 'Initials': 'SL', 'LastName': 'Jepsen', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Esben Thyssen', 'Initials': 'ET', 'LastName': 'Vestergaard', 'Affiliation': 'Medical Research Laboratories Aarhus University, Aarhus N, Denmark.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Larraufie', 'Affiliation': ""Metabolic Research Laboratories and Medical Research Council Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, Addenbrooke's Hospital, University of Cambridge, UK.""}, {'ForeName': 'Fiona Mary', 'Initials': 'FM', 'LastName': 'Gribble', 'Affiliation': ""Metabolic Research Laboratories and Medical Research Council Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, Addenbrooke's Hospital, University of Cambridge, UK.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Reimann', 'Affiliation': ""Metabolic Research Laboratories and Medical Research Council Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, Addenbrooke's Hospital, University of Cambridge, UK.""}, {'ForeName': 'Jens Otto Lunde', 'Initials': 'JOL', 'LastName': 'Jørgensen', 'Affiliation': 'Medical Research Laboratories Aarhus University, Aarhus N, Denmark.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rune Ehrenreich', 'Initials': 'RE', 'LastName': 'Kuhre', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz046']
383,32012114,Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression Among People Living With HIV (the Ziphamandla Study): Protocol for a Randomized Controlled Trial.,"BACKGROUND


There is an unmet need to develop effective, feasible, and scalable interventions for poor adherence and depression in persons living with HIV in low- and middle-income countries (LMIC).
OBJECTIVE


This study aims to investigate the effectiveness of a nurse-delivered cognitive behavioral therapy (CBT) intervention for adherence and depression (CBT-AD) among persons living with HIV who are failing first-line antiretroviral therapy (ART) in Cape Town, South Africa.
METHODS


This study is a 2-arm randomized controlled trial of CBT-AD integrated into the HIV primary care setting in South Africa. A total of 160 participants who did not achieve viral suppression from their first-line ART and have a unipolar depressive mood disorder will be randomized to receive either 8 sessions of CBT-AD or enhanced treatment as usual. Participants will be assessed for major depressive disorder using the Mini International Neuropsychiatric Interview at baseline and 4, 8, and 12 months. The primary outcomes are depression on the Hamilton Depression Scale (HAM-D; as assessed by a blinded assessor) at the 4-month assessment and changes in ART adherence (assessed via real-time, electronic monitoring with Wisepill) between baseline and the 4-month assessment. Secondary outcomes are HIV viral load and CD4 cell count at the 12-month assessment as well as ART adherence (Wisepill) and depression (HAM-D) over follow-up (4-, 8-, and 12-month assessments).
RESULTS


The trial commenced in August 2015 and recruitment began in July 2016. Enrollment was completed in June 2019.
CONCLUSIONS


Results of this study will inform whether an existing intervention (CBT-AD) can be effectively administered in LMIC by nurses with training and ongoing supervision. This will present unique opportunities to further explore the scale-up of a behavioral intervention to enhance ART adherence among persons living with HIV with major depression in a high-prevalence setting, to move toward achieving The Joint United Nations Programme on HIV/AIDS 90-90-90 goals.
TRIAL REGISTRATION


ClincialTrials.gov NCT02696824; https://clinicaltrials.gov/ct2/show/NCT02696824.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/14200.",2020,"The primary outcomes are depression on the Hamilton Depression Scale (HAM-D; as assessed by a blinded assessor) at the 4-month assessment and changes in ART adherence (assessed via real-time, electronic monitoring with Wisepill) between baseline and the 4-month assessment.","['persons living with HIV in low- and middle-income countries (LMIC', '160 participants who did not achieve viral suppression from their first-line ART and have a unipolar depressive mood disorder', 'persons living with HIV with major depression in a high-prevalence setting', 'HIV primary care setting in South Africa', 'People Living With HIV (the Ziphamandla Study', 'persons living with HIV who are failing first-line antiretroviral therapy (ART) in Cape Town, South Africa']","['behavioral intervention', 'Nurse-Delivered Cognitive Behavioral Therapy', 'nurse-delivered cognitive behavioral therapy (CBT) intervention', 'CBT-AD or enhanced treatment as usual']","['ART adherence (assessed via real-time, electronic monitoring with Wisepill', 'adherence and depression (CBT-AD', 'depression on the Hamilton Depression Scale (HAM-D', 'HIV viral load and CD4 cell count at the 12-month assessment as well as ART adherence (Wisepill) and depression (HAM-D']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",160.0,0.187622,"The primary outcomes are depression on the Hamilton Depression Scale (HAM-D; as assessed by a blinded assessor) at the 4-month assessment and changes in ART adherence (assessed via real-time, electronic monitoring with Wisepill) between baseline and the 4-month assessment.","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Joska', 'Affiliation': 'HIV Mental Health Research Unit, Neuroscience Institute, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lena S', 'Initials': 'LS', 'LastName': 'Andersen', 'Affiliation': 'HIV Mental Health Research Unit, Neuroscience Institute, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Smith-Alvarez', 'Affiliation': 'Department of Psychology, University of Miami, Coral Gables, FL, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Magidson', 'Affiliation': 'Department of Psychology, University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Jasper S', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Psychology, University of Miami, Coral Gables, FL, United States.'}, {'ForeName': 'Conall', 'Initials': 'C', 'LastName': ""O'Cleirigh"", 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Safren', 'Affiliation': 'Department of Psychology, University of Miami, Coral Gables, FL, United States.'}]",JMIR research protocols,['10.2196/14200']
384,32037549,A Randomized Trial to Evaluate OnabotulinumtoxinA for Prevention of Headaches in Adolescents With Chronic Migraine.,"OBJECTIVE


As a post-approval commitment, this dose-ranging study was undertaken to evaluate efficacy and safety of onabotulinumtoxinA in adolescents.
BACKGROUND


In adolescents, migraine is often undiagnosed or misdiagnosed and can present unique management challenges. OnabotulinumtoxinA was approved for prevention of chronic migraine (CM) in adults in 2010.
METHODS


This multicenter, double-blind, parallel-group, randomized trial assessed a single treatment of onabotulinumtoxinA (155 U or 74 U) vs placebo (intramuscular saline) administered via the recommended fixed-dose fixed site paradigm in adolescents with CM aged 12 to <18 years. The primary efficacy measure was change in frequency of headache days from baseline at week 12; other measures included change in frequency of headache days at weeks 4 and 8 and change in frequency of severe headache days. Safety and tolerability were assessed.
RESULTS


Of 125 randomized patients (onabotulinumtoxinA 155 U, n = 45; onabotulinumtoxinA 74 U, n = 43; placebo, n = 37), all were included in the primary efficacy analysis, and 115 (92.0%) completed the study. Lack of efficacy was the primary reason for discontinuing (n = 4; 3.2%); no patients discontinued because of adverse events. All treatments reduced frequency of headache days at week 12, with no significant differences between treatments. The mean (95% confidence interval) changes from baseline in the frequency of headache days during the 28-day period ending at week 12 (primary endpoint) were -6.3 (-8.5, -4.2), -6.4 (-8.8, -4.0), and -6.8 (-9.6, -4.1) days in the onabotulinumtoxinA 155 U, onabotulinumtoxinA 74 U, and placebo groups, respectively (P ≥ .474). All treatments reduced frequency of severe headache days and were well-tolerated; serious adverse events (n = 3) were considered unrelated to treatment and resolved without sequelae. The most commonly reported treatment-emergent adverse events were neck pain (n = 8), upper respiratory tract infection (n = 7), migraine, and nasopharyngitis (n = 5 each).
CONCLUSION


Although this study did not meet its efficacy endpoints, onabotulinumtoxinA was well tolerated in this adolescent population. Given previous data demonstrating the benefits of onabotulinumtoxinA in adults with CM, additional studies with design modifications, including adequate statistical power, to assess the efficacy of multiple treatment cycles of onabotulinumtoxinA for CM prevention in adolescents may be informative.",2020,All treatments reduced frequency of severe headache days and were well-tolerated; serious adverse events (n = 3) were considered unrelated to treatment and resolved without sequelae.,"['125 randomized patients (onabotulinumtoxinA 155\xa0U, n\xa0=\xa045; onabotulinumtoxinA 74\xa0U, n\xa0=\xa043; placebo, n\xa0=\xa037), all were included in the primary efficacy analysis, and\xa0115 (92.0%) completed the study', 'adults with CM', 'chronic migraine (CM) in adults in 2010', 'Adolescents With Chronic Migraine', 'adolescents with CM aged 12 to <18\xa0years']","['OnabotulinumtoxinA', 'onabotulinumtoxinA (155\xa0U or 74\xa0U) vs placebo (intramuscular saline', 'onabotulinumtoxinA']","['frequency of severe headache days and were well-tolerated; serious adverse events', 'frequency of headache days', 'Safety and tolerability', 'frequency of severe headache days']","[{'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1960870', 'cui_str': 'Chronic migraine'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",3.0,0.263616,All treatments reduced frequency of severe headache days and were well-tolerated; serious adverse events (n = 3) were considered unrelated to treatment and resolved without sequelae.,"[{'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Winner', 'Affiliation': 'Palm Beach Headache Center, Premiere Research Institute@Palm Beach Neurology, West Palm Beach, FL, USA.'}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Kabbouche', 'Affiliation': ""Cincinnati Children's Hospital Medical Centre, Cincinnati, OH, USA.""}, {'ForeName': 'Marcy', 'Initials': 'M', 'LastName': 'Yonker', 'Affiliation': ""University of Colorado School of Medicine/Children's Hospital, Aurora, CO, USA.""}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Wangsadipura', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Lum', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Mitchell F', 'Initials': 'MF', 'LastName': 'Brin', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}]",Headache,['10.1111/head.13754']
385,32179965,[Evaluation of a basic educational program for patients with rheumatoid arthritis].,"BACKGROUND


A new conceptual framework has enabled the flexible development of rheumatological patient educational programs for different healthcare settings. On this basis, a 5‑h basic training program for patients with rheumatoid arthritis (RA) was developed to be used in specialized centers. Rheumatologists and psychologists were first trained and then the efficacy of the patient training program was evaluated based on the causal model of patient education.
METHODS


The externally randomized waiting control group study with 249 RA patients included 3 measurement points. The impact of the 5‑h basic training on disease and treatment-related knowledge as well as health competence of RA patients was examined. Secondary questions included attitudinal parameters, communication competence, effects on the disease and satisfaction with the educational program. Data were analyzed on an intention to treat basis by means of covariance analyses for the main target variables, adjusted for baseline values.
RESULTS


The analyses showed that the training program was effective. Even 3 months after training, participants reported more knowledge and health competence than the waiting control group, with small to medium-sized effects (d = 0.37 and 0.38, respectively). With the exception of disease communication, no other effects of training were observed in the secondary objectives.
CONCLUSION


The basic training program provides a good foundation to develop further interventions to improve attitudinal and disease parameters. It can serve as a central component for rheumatological healthcare for patients with RA at various levels.",2020,"Even 3 months after training, participants reported more knowledge and health competence than the waiting control group, with small to medium-sized effects (d = 0.37 and 0.38, respectively).","['patients with rheumatoid arthritis (RA', 'patients with rheumatoid arthritis', '249 RA patients included 3 measurement points']",['basic educational program'],"['knowledge and health competence', 'attitudinal parameters, communication competence, effects on the disease and satisfaction with the educational program']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",249.0,0.0177129,"Even 3 months after training, participants reported more knowledge and health competence than the waiting control group, with small to medium-sized effects (d = 0.37 and 0.38, respectively).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gerlich', 'Affiliation': 'Arbeitsbereich Medizinische Psychologie und Psychotherapie im Zentrum für psychische Gesundheit (ZEP), Universität Würzburg, Klinikstr.\xa03, 97070, Würzburg, Deutschland. christian.gerlich@uni-wuerzburg.de.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Andreica', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Ruhr-Universität Bochum, Herne, Deutschland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Küffner', 'Affiliation': 'Arbeitsbereich Medizinische Psychologie und Psychotherapie im Zentrum für psychische Gesundheit (ZEP), Universität Würzburg, Klinikstr.\xa03, 97070, Würzburg, Deutschland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Krause', 'Affiliation': 'Praxis Innere Medizin/Rheumatologie, Gladbeck, Deutschland.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Lakomek', 'Affiliation': 'Klinik für Rheumatologie und Geriatrie, Johannes Wesling Klinikum Minden, Minden, Deutschland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Reusch', 'Affiliation': 'Zentrum Patientenschulung und Gesundheitsförderung, Würzburg, Deutschland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Ruhr-Universität Bochum, Herne, Deutschland.'}]",Zeitschrift fur Rheumatologie,['10.1007/s00393-020-00769-4']
386,31146872,Sex-Based Differences in Outcomes After Mitral Valve Surgery for Severe Ischemic Mitral Regurgitation: From the Cardiothoracic Surgical Trials Network.,"OBJECTIVES


This study investigated sex-based differences in outcomes after mitral valve (MV) surgery for severe ischemic mitral regurgitation (SIMR).
BACKGROUND


Whether differences in outcomes exist between men and women after surgery for SIMR remains unknown.
METHODS


Patients enrolled in a randomized trial comparing MV replacement versus MV repair for SIMR were included and followed for 2 years. Endpoints for this analysis included all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE) (defined as the composite of death, stroke, hospitalization for heart failure, worsening New York Heart Association functional class or MV re-operation), quality of life (QOL), functional status, and percentage of change in left ventricular end-systolic volume index (LVESVI) from baseline through 2 years.
RESULTS


Of 251 patients enrolled in the trial, 96 (38.2%) were women. Compared with men, women had smaller LV volumes and effective regurgitant orifice areas (EROA) but greater EROA/left ventricular (LV) end-diastolic volume ratios. At 2 years, women had higher rates of all-cause mortality (27.1% vs. 17.4%, respectively; adjusted hazard ratio [adjHR]: 1.85; 95% confidence interval [CI]: 1.05 to 3.26; p = 0.03) and of MACCE (49.0% vs. 38.1%, respectively; adjHR: 1.58; 95% CI: 1.06 to 2.37; p = 0.02). Women also reported worse QOL and functional status at 2 years. There were no significant differences in the percentage of change over 2 years in LVESVI between women and men (adjβ: -10.4; 95% CI: -23.4 to 2.6; p = 0.12).
CONCLUSIONS


Women with SIMR displayed different echocardiographic features and experienced higher mortality and worse QOL after MV surgery than men. There were no significant differences in the degree of reverse LV remodeling between sexes. (Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation [Severe Ischemic Mitral Regurgitation]; NCT00807040).",2019,"At 2 years, women had higher rates of all-cause mortality (27.1% vs. 17.4%, respectively; adjusted hazard ratio [adjHR]: 1.85; 95% confidence interval [CI]: 1.05 to 3.26; p = 0.03) and of MACCE (49.0% vs. 38.1%, respectively; adjHR: 1.58; 95% CI: 1.06 to 2.37; p = 0.02).","['People With Severe Chronic Ischemic Mitral Regurgitation [Severe Ischemic Mitral Regurgitation', 'Severe\xa0Ischemic Mitral Regurgitation', 'severe ischemic mitral regurgitation (SIMR', '251 patients enrolled in the trial, 96 (38.2%) were women', 'men and women after surgery for SIMR remains unknown', 'Patients enrolled']","[""Repairing Versus Replacing the Heart's Mitral Valve"", 'MV replacement versus MV repair for SIMR', 'mitral valve (MV) surgery']","['rates of all-cause mortality', 'smaller LV volumes and effective regurgitant orifice areas (EROA) but greater EROA/left ventricular (LV) end-diastolic volume ratios', 'cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE) (defined as the composite of death, stroke, hospitalization for heart failure, worsening New York Heart Association functional class or MV re-operation), quality of life (QOL), functional status, and percentage of change in left ventricular end-systolic volume index (LVESVI', 'degree of reverse LV remodeling', 'percentage of change over 2 years in LVESVI', 'QOL and functional status', 'mortality and worse QOL']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C4087284', 'cui_str': 'Ischaemic mitral regurgitation'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0026264', 'cui_str': 'Bicuspid Valve'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0455833', 'cui_str': 'Left ventricular end diastolic volume'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0034380'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",251.0,0.277475,"At 2 years, women had higher rates of all-cause mortality (27.1% vs. 17.4%, respectively; adjusted hazard ratio [adjHR]: 1.85; 95% confidence interval [CI]: 1.05 to 3.26; p = 0.03) and of MACCE (49.0% vs. 38.1%, respectively; adjHR: 1.58; 95% CI: 1.06 to 2.37; p = 0.02).","[{'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Giustino', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Overbey', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'Department of Regenerative Medicine Research, Texas Heart Institute, Houston, Texas.'}, {'ForeName': 'Gorav', 'Initials': 'G', 'LastName': 'Ailawadi', 'Affiliation': 'Division of Thoracic and Cardiovascular Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Kirkwood', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'DeRose', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Gillinov', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Dagenais', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.'}, {'ForeName': 'Mary-Lou', 'Initials': 'ML', 'LastName': 'Mayer', 'Affiliation': 'Department of Surgery, Division of Cardiovascular Surgery, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Moskowitz', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Bagiella', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'National Heart, Lung, and Blood Institute of the National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Grayburn', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Smith', 'Affiliation': 'Division of Cardiothoracic Surgery, Department of Surgery, Duke University, Durham, North Carolina.'}, {'ForeName': 'Annetine', 'Initials': 'A', 'LastName': 'Gelijns', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: Annetine.gelijns@mssm.edu.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': ""O'Gara"", 'Affiliation': ""Division of Cardiology, Brigham and Women's' Hospital, Boston, Massachusetts.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Acker', 'Affiliation': 'Department of Surgery, Division of Cardiovascular Surgery, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Hung', 'Affiliation': 'Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.03.001']
387,32167784,Primary Care Management of Children with Attention-Deficit/Hyperactivity Disorder Appears More Assertive Following Brief Psychiatric Intervention Compared with Single Session Consultation.,"Objectives:  We examined primary care providers' (PCPs') management of attention-deficit/hyperactivity disorder (ADHD) during and following families' participation in two arms of the Children's ADHD Telemental Health Treatment Study. We hypothesized that more intensive treatment during the trial would show an ""after-effect"" with more assertive PCPs' management during short term follow-up.  Methods:  We conducted a pragmatic follow-up of PCPs' management of children with ADHD who had been randomized to two service delivery models. In the Direct Service Model, psychiatrists provided six sessions over 22 weeks of pharmacotherapy followed by behavior training. In the Consultation Model, psychiatrists provided a single-session consultation and made treatment recommendations to PCPs who implemented these recommendations at their discretion for 22 weeks. At the end of the trial, referring PCPs for both service delivery models resumed ADHD treatment for 10 weeks. We performed intent-to-treat analysis using all 223 original participants. We applied linear regression models on continuous outcomes, Poisson regression models on count outcomes, and logistic regression models to binary outcomes. Missing data were addressed through imputations.  Results:  Participants in the Direct Service Model had more ADHD visits than those in the Consultation Model across the full 32 weeks (mean = 7.05 visits vs. 3.36 visits; adjusted rate ratio = 2.1 [1.85-2.38];  p  < 0.0001). During follow-up, participants in the DSM were more likely to be taking ADHD-related medications (82% vs. 61%; adjusted odds ratio = 2.44 [1.24-4.81],  p  = 0.01). At 32 weeks, participants in the Direct Service Model had higher stimulant dosages (adjusted difference = 5.64 [0.12-11.15] mg;  p  = 0.046).  Conclusion:  These results from a pragmatic follow-up of a randomized trial suggest an ""after-effect"" for brief intensive treatment in the Direct Service Model on the short term follow-up management of ADHD in primary care.",2020,had more ADHD visits than those in the Consultation Model across the full 32 weeks,"['223 original participants', 'children with ADHD who had been randomized to two service delivery models', 'Results:  Participants in the Direct Service Model', 'Children with Attention-Deficit/Hyperactivity Disorder']","['Psychiatric Intervention', ""primary care providers' (PCPs') management of attention-deficit/hyperactivity disorder (ADHD""]",['ADHD visits'],"[{'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C1263846', 'cui_str': 'ADDH'}]",,0.0557932,had more ADHD visits than those in the Consultation Model across the full 32 weeks,"[{'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Rockhill', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'L Lee', 'Initials': 'LL', 'LastName': 'Carlisle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'Qu', 'Affiliation': ""Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Vander Stoep', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'French', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Myers', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2020.0013']
388,32167792,Effects of Fish Oil Monotherapy on Depression and Prefrontal Neurochemistry in Adolescents at High Risk for Bipolar I Disorder: A 12-Week Placebo-Controlled Proton Magnetic Resonance Spectroscopy Trial.,"Objectives:  To evaluate the clinical and neurochemical effects of 12-week fish oil, a source of omega-3 polyunsaturated fatty acids ( n -3 PUFAs), in depressed adolescents with a family history of bipolar I disorder.  Methods:  Adolescents with a current Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision diagnosis of Major Depressive Disorder or Depressive Disorder not otherwise specified, a Childhood Depression Rating Scale-Revised (CDRS-R) Version raw score of ≥40, and at least one biological parent with bipolar I disorder were randomized to double-blind treatment with fish oil (2100 mg/day) or placebo for 12 weeks. The primary outcome measure was change in CDRS-R total score, and secondary outcomes measures were change in manic symptoms (Young Mania Rating Scale), global symptom and functioning measures (Clinical Global Impression-Severity [CGI-S] /CGI Improvement [CGI-I], Children's Global Assessment Scale, and Child Behavior Checklist), safety and laboratory measures, and anterior cingulate cortex (ACC) and bilateral ventrolateral prefrontal cortex neurometabolite concentrations using proton magnetic resonance spectroscopy at 4 T.  Results:  Fifty-six patients were randomized, and 42 completed the 12-week trial (placebo:  n  = 21; fish oil,  n  = 21). Subjects randomized to fish oil, but not placebo, exhibited a significant baseline to endpoint increase in erythrocyte  n -3 PUFAs. Reductions in CDRS-R scores did not differ between treatment groups ( p  = 0.15), and similar remission ( p  = 0.58) and response ( p  = 0.77) rates were observed. Fish oil produced a significantly greater decrease in CGI-S ( p  = 0.0042) and CGI-I ( p  = 0.036) scores compared with placebo. Baseline to endpoint change in ACC creatine ( p  = 0.004) and ACC choline (Cho) ( p  = 0.024) differed significantly between groups. Baseline ACC Cho levels were inversely correlated with baseline and baseline to endpoint change in CDRS-R scores, and baseline to endpoint change in ACC Cho correlated with baseline-endpoint change in CDRS-R scores and  n -3 PUFA. There were no group differences in safety and tolerability ratings or laboratory measures.  Conclusions:  Fish oil monotherapy was not superior to placebo for reducing depressive symptoms in high-risk youth as assessed by the CDRS-R, but was safe and well tolerated and superior to placebo on clinician ratings of global symptom improvement. Associations among ACC Cho levels, depression symptom severity, and  n -3 PUFA warrant additional investigation.",2020,"Fish oil monotherapy was not superior to placebo for reducing depressive symptoms in high-risk youth as assessed by the CDRS-R, but was safe and well tolerated and superior to placebo on clinician ratings of global symptom improvement.","['Adolescents at High Risk for Bipolar I Disorder', 'Adolescents with a current Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision diagnosis of Major Depressive Disorder or Depressive Disorder not otherwise specified, a Childhood Depression Rating Scale-Revised (CDRS-R) Version raw score of ≥40, and at least one biological parent with bipolar I disorder', 'depressed adolescents with a family history of bipolar I disorder']","['12-week fish oil, a source of omega-3 polyunsaturated fatty acids ( n -3 PUFAs', 'CGI', 'Fish oil monotherapy', 'placebo', 'fish oil', 'Fish Oil Monotherapy', 'Placebo', 'placebo:  n \u2009=\u200921; fish oil,  n \u2009=\u200921']","['CDRS-R scores', 'depressive symptoms', 'CGI', 'safety and tolerability ratings or laboratory measures', 'Baseline ACC Cho levels', 'change in CDRS-R total score', 'manic symptoms (Young Mania Rating Scale), global symptom and functioning measures (Clinical Global Impression-Severity [CGI-S', 'Depression and Prefrontal Neurochemistry', ""Improvement [CGI-I], Children's Global Assessment Scale, and Child Behavior Checklist), safety and laboratory measures, and anterior cingulate cortex (ACC) and bilateral ventrolateral prefrontal cortex neurometabolite concentrations"", 'ACC creatine', 'ACC choline (Cho', 'erythrocyte  n -3 PUFAs', 'CGI-S', 'similar remission']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0853193', 'cui_str': 'Bipolar I disorder (disorder)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2363919', 'cui_str': 'Childhood depression'}, {'cui': 'C0222045'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0337465', 'cui_str': 'Natural parent (person)'}, {'cui': 'C0241889', 'cui_str': 'Family Medical History'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0027820', 'cui_str': 'Neurochemistry'}, {'cui': 'C3472495', 'cui_str': ""Children's global assessment scale""}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",56.0,0.325419,"Fish oil monotherapy was not superior to placebo for reducing depressive symptoms in high-risk youth as assessed by the CDRS-R, but was safe and well tolerated and superior to placebo on clinician ratings of global symptom improvement.","[{'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'McNamara', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Strawn', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Max J', 'Initials': 'MJ', 'LastName': 'Tallman', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Welge', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'L Rodrigo', 'Initials': 'LR', 'LastName': 'Patino', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Blom', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'DelBello', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2019.0124']
389,29654915,"Efficacy of MaZiRenWan, a Chinese Herbal Medicine, in Patients With Functional Constipation in a Randomized Controlled Trial.","BACKGROUND & AIMS


The Chinese herbal medicine, MaZiRenWan (MZRW), has been used for more than 2000 years to treat constipation, but it has not been tested in a randomized controlled trial. We performed a trial to evaluate the efficacy and safety of MZRW, compared with the stimulant laxative senna or placebo, for patients with functional constipation (FC).
METHODS


We performed a double-blind, double-dummy, trial of 291 patients with FC based on Rome III criteria, seen at 8 clinics in Hong Kong from June 2013 through August 2015. Patients were observed for 2 weeks and then assigned randomly (1:1:1) to groups given MZRW (7.5 g, twice daily), senna (15 mg daily), or placebo for 8 weeks. Patients were then followed for 8 weeks and evaluated at baseline and weeks 4, 8 (end of treatment), and 16 (end of follow up). Participants recorded information on stool form and frequency, feeling of complete evacuation, and research medication taken. Data on individual bowel symptoms, global symptom improvement, and adverse events were collected. A complete response was defined as an increase ≥1 complete spontaneous bowel movement (CSBM)/week from baseline (the primary outcome). Secondary outcomes included response during the follow-up period, colonic transit, individual and global symptom assessments, quality of life measured with 36-item short form Chinese version, and adverse events.
RESULTS


Although there was no statistically significant difference in proportions of patients with a complete response to MZRW (68%) vs. senna (57.7%) (P = .14) at week 8, there was a statistically significant difference vs. placebo (33.0%) (P < .005). At the 16-week timepoint (after the 8-week follow-up period), 47.4% of patients had a complete response to MZRW, 20.6% had a complete response to senna, and 17.5% had a complete response to placebo (P < .005 for MZRW vs. placebo). The group that received MZRW group also had significant increases in colonic transit and reduced severity of constipation, straining, incomplete evacuation, and global constipation symptoms compared with the groups that received placebo or senna in (P < .05 for all comparisons).
CONCLUSIONS


In a randomized controlled trial of 291 patients with FC, we found MZRW to be well-tolerated and effective in increasing CSBM/week. MZRW did not appear to be more effective than senna and might be considered as an alternative to this drug. ClincialTrials.gov no: NCT01695850.",2019,", there was a statistically significant difference vs. placebo (33.0%) (P < .005).","['291 patients with FC based on Rome III criteria, seen at 8 clinics in Hong Kong from June 2013 through August 2015', '291 patients with FC', 'patients with functional constipation (FC', 'Patients With Functional Constipation']","['MaZiRenWan, a Chinese Herbal Medicine', 'MZRW', 'placebo', 'stimulant laxative senna or placebo', 'Chinese herbal medicine, MaZiRenWan (MZRW']","['response during the follow-up period, colonic transit, individual and global symptom assessments, quality of life measured with 36-item short form Chinese version, and adverse events', 'efficacy and safety', 'individual bowel symptoms, global symptom improvement, and adverse events', 'stool form and frequency, feeling of complete evacuation, and research medication taken', 'colonic transit and reduced severity of constipation, straining, incomplete evacuation, and global constipation symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional (disorder)'}]","[{'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0304553', 'cui_str': 'Stimulant laxatives (product)'}, {'cui': 'C3489575', 'cui_str': 'sennosides, USP'}]","[{'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0035168'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}]",291.0,0.596451,", there was a statistically significant difference vs. placebo (33.0%) (P < .005).","[{'ForeName': 'Linda L D', 'Initials': 'LLD', 'LastName': 'Zhong', 'Affiliation': 'Hong Kong Chinese Medicine Study Centre, Hong Kong Baptist University, Hong Kong, P. R. China.'}, {'ForeName': 'Chung-Wah', 'Initials': 'CW', 'LastName': 'Cheng', 'Affiliation': 'Hong Kong Chinese Medicine Study Centre, Hong Kong Baptist University, Hong Kong, P. R. China.'}, {'ForeName': 'Wai', 'Initials': 'W', 'LastName': 'Kun', 'Affiliation': 'Hong Kong Chinese Medicine Study Centre, Hong Kong Baptist University, Hong Kong, P. R. China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': 'Hong Kong Chinese Medicine Study Centre, Hong Kong Baptist University, Hong Kong, P. R. China.'}, {'ForeName': 'Dong-Dong', 'Initials': 'DD', 'LastName': 'Hu', 'Affiliation': 'Hong Kong Chinese Medicine Study Centre, Hong Kong Baptist University, Hong Kong, P. R. China.'}, {'ForeName': 'Zi-Wan', 'Initials': 'ZW', 'LastName': 'Ning', 'Affiliation': 'Hong Kong Chinese Medicine Study Centre, Hong Kong Baptist University, Hong Kong, P. R. China.'}, {'ForeName': 'Hai-Tao', 'Initials': 'HT', 'LastName': 'Xiao', 'Affiliation': 'Hong Kong Chinese Medicine Study Centre, Hong Kong Baptist University, Hong Kong, P. R. China.'}, {'ForeName': 'Cheng-Yuan', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Hong Kong Chinese Medicine Study Centre, Hong Kong Baptist University, Hong Kong, P. R. China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Hong Kong Chinese Medicine Study Centre, Hong Kong Baptist University, Hong Kong, P. R. China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Hong Kong Chinese Medicine Study Centre, Hong Kong Baptist University, Hong Kong, P. R. China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Tian', 'Affiliation': 'Hong Kong Chinese Medicine Study Centre, Hong Kong Baptist University, Hong Kong, P. R. China.'}, {'ForeName': 'King-Hong', 'Initials': 'KH', 'LastName': 'Chan', 'Affiliation': 'Department of Family Medicine & General Out-patient Clinics, Kowloon Central Cluster, Hospital Authority, Kowloon City, Hong Kong, P. R. China.'}, {'ForeName': 'Ting-Wa', 'Initials': 'TW', 'LastName': 'Lam', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hospital Authority, Hong Kong, P. R. China.'}, {'ForeName': 'Xiao-Rui', 'Initials': 'XR', 'LastName': 'Chen', 'Affiliation': 'Department of Family Medicine & General Out-patient Clinics, Kowloon Central Cluster, Hospital Authority, Kowloon City, Hong Kong, P. R. China.'}, {'ForeName': 'Chi-Tak', 'Initials': 'CT', 'LastName': 'Wong', 'Affiliation': 'Department of Family Medicine & General Out-patient Clinics, Kowloon Central Cluster, Hospital Authority, Kowloon City, Hong Kong, P. R. China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Hong Kong Chinese Medicine Study Centre, Hong Kong Baptist University, Hong Kong, P. R. China.'}, {'ForeName': 'Ai-Ping', 'Initials': 'AP', 'LastName': 'Lu', 'Affiliation': 'Hong Kong Chinese Medicine Study Centre, Hong Kong Baptist University, Hong Kong, P. R. China.'}, {'ForeName': 'Justin C Y', 'Initials': 'JCY', 'LastName': 'Wu', 'Affiliation': 'Institute of Digestive Disease, Faculty of Medicine, The Chinese University of Hong Kong, P. R. China. Electronic address: justinwu@cuhk.edu.hk.'}, {'ForeName': 'Zhao-Xiang', 'Initials': 'ZX', 'LastName': 'Bian', 'Affiliation': 'Hong Kong Chinese Medicine Study Centre, Hong Kong Baptist University, Hong Kong, P. R. China. Electronic address: bzxiang@hkbu.edu.hk.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2018.04.005']
390,32166527,Feasibility of Group Parent Training for Children with Autism Spectrum Disorder and Disruptive Behavior: A Demonstration Pilot.,Delivery of interventions in a group format is a potential solution to limited access to specialized services for children with autism spectrum disorder (ASD). We conducted an open feasibility trial of group-based RUBI parent training in 18 children (mean age 6.12 ± 1.95 years) with ASD and disruptive behaviors. Parents participated in one of five groups (3 to 4 parents per group). Eighty-three percent of participants completed the 24-week trial. Session attendance was moderate (74.2%). All parents indicated that they would recommend the treatment. Therapists demonstrated 98.8% fidelity to the manual. Eleven of 18 (64.7%) participants were rated as much/very much improved by an independent evaluator at Week 24. Preliminary efficacy findings justify further study.,2020,Delivery of interventions in a group format is a potential solution to limited access to specialized services for children with autism spectrum disorder (ASD).,"['children with autism spectrum disorder (ASD', 'Eighty-three percent of participants completed the 24-week trial', 'Children with Autism Spectrum Disorder and Disruptive Behavior', '18 children (mean age 6.12\u2009±\u20091.95\xa0years) with ASD and disruptive behaviors']","['group-based RUBI parent training', 'Group Parent Training']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0474416', 'cui_str': 'Disruptive Behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],18.0,0.0416738,Delivery of interventions in a group format is a potential solution to limited access to specialized services for children with autism spectrum disorder (ASD).,"[{'ForeName': 'T Lindsey', 'Initials': 'TL', 'LastName': 'Burrell', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, 2015 Uppergate Drive, Atlanta, GA, 30329, USA. Lindsey.Burrell@choa.org.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Postorino', 'Affiliation': 'JFK Partners School of Medicine, University of Colorado Denver, 13121 E. 17th Avenue, C234, Aurora, CO, 80045, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Scahill', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, 2015 Uppergate Drive, Atlanta, GA, 30329, USA.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Rea', 'Affiliation': 'Department of Psychology, University of Georgia, 125 Baldwin Drive, Athens, GA, 30602, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Gillespie', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, 2015 Uppergate Drive, Atlanta, GA, 30329, USA.'}, {'ForeName': 'A Nichole', 'Initials': 'AN', 'LastName': 'Evans', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, 2015 Uppergate Drive, Atlanta, GA, 30329, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bearss', 'Affiliation': ""Seattle Children's Autism Center and Research Institute, 4909 25th Avenue Northeast, Seattle, WA, 98105, USA.""}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04427-1']
391,32166308,A Bayesian adaptive randomized phase II multicenter trial of bevacizumab with or without vorinostat in adults with recurrent glioblastoma.,"BACKGROUND


Bevacizumab has promising activity against recurrent glioblastoma (GBM). However, acquired resistance to this agent results in tumor recurrence. We hypothesized that vorinostat, a histone deacetylase (HDAC) inhibitor with anti-angiogenic effects, would prevent acquired resistance to bevacizumab.
METHODS


This multicenter phase II trial used a Bayesian adaptive design to randomize patients with recurrent GBM to bevacizumab alone or bevacizumab plus vorinostat with the primary endpoint of progression-free survival (PFS) and secondary endpoints of overall survival (OS) and clinical outcomes assessment (MD Anderson Symptom Inventory Brain Tumor module [MDASI-BT]). Eligible patients were adults (≥18 y) with histologically confirmed GBM recurrent after prior radiation therapy, with adequate organ function, KPS ≥60, and no prior bevacizumab or HDAC inhibitors.
RESULTS


Ninety patients (bevacizumab + vorinostat: 49, bevacizumab: 41) were enrolled, of whom 74 were evaluable for PFS (bevacizumab + vorinostat: 44, bevacizumab: 30). Median PFS (3.7 vs 3.9 mo, P = 0.94, hazard ratio [HR] 0.63 [95% CI: 0.38, 1.06, P = 0.08]), median OS (7.8 vs 9.3 mo, P = 0.64, HR 0.93 [95% CI: 0.5, 1.6, P = 0.79]) and clinical benefit were similar between the 2 arms. Toxicity (grade ≥3) in 85 evaluable patients included hypertension (n = 37), neurological changes (n = 2), anorexia (n = 2), infections (n = 9), wound dehiscence (n = 2), deep vein thrombosis/pulmonary embolism (n = 2), and colonic perforation (n = 1).
CONCLUSIONS


Bevacizumab combined with vorinostat did not yield improvement in PFS or OS or clinical benefit compared with bevacizumab alone or a clinical benefit in adults with recurrent GBM. This trial is the first to test a Bayesian adaptive design with adaptive randomization and Bayesian continuous monitoring in patients with primary brain tumor and demonstrates the feasibility of using complex Bayesian adaptive design in a multicenter setting.",2020,"CONCLUSIONS


Bevacizumab combined with vorinostat did not yield improvement in PFS, OS or clinical benefit compared with bevacizumab alone nor a clinical benefit in adults with recurrent GBM.","['Ninety patients (bevacizumab+vorinostat:49, bevacizumab:41) were enrolled of whom 74 were evaluable for PFS (bevacizumab+vorinostat:44, bevacizumab:30', 'Eligible patients were adults (≥18 yrs) with histologically confirmed GBM recurrent after prior radiation therapy, with adequate organ function, KPS≥60, and no prior bevacizumab or HDAC inhibitors', '85 evaluable patients included hypertension (n=37), neurological changes (n=2), anorexia (n=2), infections (n=9), wound dehiscence (n=2), DVT/PE (n=2), and colonic perforation (n=1', 'adults with recurrent GBM', 'Adults with Recurrent Glioblastoma', 'randomize patients with recurrent GBM to', 'patients with primary brain tumor']","['bevacizumab', 'bevacizumab alone or bevacizumab plus vorinostat', 'Bevacizumab', 'adaptive randomization and Bayesian continuous monitoring']","['Median PFS', 'progression-free survival (PFS) and secondary end points of overall survival (OS) and clinical outcomes assessment (MDASI-BT', 'Toxicity', 'median OS', 'clinical benefit']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1512474', 'cui_str': 'HDAC Inhibitors'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence (morphologic abnormality)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0347646', 'cui_str': 'Perforation of colon (disorder)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0750974', 'cui_str': 'Primary Brain Neoplasms'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0085565', 'cui_str': 'Outcomes Assessment'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.154796,"CONCLUSIONS


Bevacizumab combined with vorinostat did not yield improvement in PFS, OS or clinical benefit compared with bevacizumab alone nor a clinical benefit in adults with recurrent GBM.","[{'ForeName': 'Vinay K', 'Initials': 'VK', 'LastName': 'Puduvalli', 'Affiliation': 'Division of Neuro-Oncoology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Neuro-Oncology Branch, National Institute of Health, Bethesda, Maryland.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center (MDACC), Houston, Texas.'}, {'ForeName': 'Terri S', 'Initials': 'TS', 'LastName': 'Armstrong', 'Affiliation': 'Neuro-Oncology Branch, National Institute of Health, Bethesda, Maryland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Vera', 'Affiliation': 'Neuro-Oncology Branch, National Institute of Health, Bethesda, Maryland.'}, {'ForeName': 'Jimin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center (MDACC), Houston, Texas.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Division of Neuro-Oncoology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Giglio', 'Affiliation': 'Division of Neuro-Oncoology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Colman', 'Affiliation': 'Department of Neurosurgery, Huntsman Cancer Center, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Walbert', 'Affiliation': 'Department of Neurology and Neurosurgery, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Raizer', 'Affiliation': 'Department of Neurology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Morris D', 'Initials': 'MD', 'LastName': 'Groves', 'Affiliation': 'Texas Oncology Austin Brain Tumor Center, Austin, Texas.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tran', 'Affiliation': 'Department of Medicine, Washington University, St Louis, Missouri.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Iwamoto', 'Affiliation': 'Division of Neurooncology, Columbia University, New York, New York.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Avgeropoulos', 'Affiliation': 'Orlando Health UF Health Cancer Center, Orlando, Florida.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Paleologos', 'Affiliation': 'Advocate Health Care, Downers Grove, Illinois.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Fink', 'Affiliation': 'Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peereboom', 'Affiliation': 'Department of Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Chamberlain', 'Affiliation': 'Department of Neurology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Merrell', 'Affiliation': 'Department of Neurology, North Shore University Health System, Evanston, Illinois.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Penas Prado', 'Affiliation': 'Department of Neuro-Oncology, The University of \u2009Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'W K Alfred', 'Initials': 'WKA', 'LastName': 'Yung', 'Affiliation': 'Department of Neuro-Oncology, The University of \u2009Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Gilbert', 'Affiliation': 'Neuro-Oncology Branch, National Institute of Health, Bethesda, Maryland.'}]",Neuro-oncology,['10.1093/neuonc/noaa062']
392,32164428,Headache and non-headache symptoms provoked by nitroglycerin in migraineurs: A human pharmacological triggering study.,"BACKGROUND


Studying a spontaneous migraine attack is challenging, particularly the earliest components. Nitroglycerin is a potent, reliable and reproducible migraine trigger of the entirety of the migraine attack, making its use experimentally attractive.
METHODS


Fifty-three subjects with migraine with a history of spontaneous premonitory symptoms were exposed to a 0.5 mcg/kg/min nitroglycerin infusion. Eighty-three percent (n = 44) developed typical premonitory and headache symptomatology. Fifty-seven percent (n = 25) were invited back to further study visits, during which they were re-exposed to nitroglycerin or placebo infusion in a double-blind randomised design. The phenotype of premonitory symptoms and headache was captured and compared to spontaneous attacks and between triggered attacks using agreement analysis.
RESULTS


More premonitory symptoms were triggered with nitroglycerin than placebo (mean symptom difference = 4,  t 20  = 7.06,  p  < 0.001). The agreement in triggering for the most commonly reported premonitory symptoms (concentration difficulty and tiredness) was >66%. The retriggering agreement for all but one premonitory symptom was >60%. The agreement in timing to onset of premonitory symptoms was reliable across two triggered attacks. The agreement with spontaneous attacks and between attacks for headache and its associated symptoms, including laterality, was less reliable.
CONCLUSIONS


Nitroglycerin can reliably and reproducibly provoke premonitory symptomatology associated with migraine. This forms an ideal model to study the earliest manifestations of migraine attacks.",2020,"More premonitory symptoms were triggered with nitroglycerin than placebo (mean symptom difference = 4,  t 20  = 7.06,  p  < 0.001).","['Eighty-three percent (n\u2009', 'migraineurs', 'Fifty-three subjects with migraine with a history of spontaneous premonitory symptoms', 'Fifty-seven percent (n\u2009']","['nitroglycerin or placebo infusion', 'nitroglycerin infusion', 'placebo', 'Nitroglycerin', 'nitroglycerin']","['Headache', 'typical premonitory and headache symptomatology']","[{'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0240805', 'cui_str': 'Prodrome'}, {'cui': 'C4517815', 'cui_str': '57'}]","[{'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",53.0,0.162561,"More premonitory symptoms were triggered with nitroglycerin than placebo (mean symptom difference = 4,  t 20  = 7.06,  p  < 0.001).","[{'ForeName': 'Nazia', 'Initials': 'N', 'LastName': 'Karsan', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Pyari R', 'Initials': 'PR', 'LastName': 'Bose', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Thompson', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jayde', 'Initials': 'J', 'LastName': 'Newman', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",Cephalalgia : an international journal of headache,['10.1177/0333102420910114']
393,32164442,Effects of a naturalistic intervention on the speech outcomes of young children with cleft palate.,"Purpose : The purpose of this study was to investigate the extent to which a naturalistic communication intervention, Enhanced Milieu Teaching with Phonological Emphasis (EMT + PE) improved the speech outcomes of toddlers with cleft palate with or without cleft lip (CP ± L) Method : This study was a stratified randomised controlled trial.Setting: Treatment was delivered in a university clinic by a trained speech-language pathologist.Thirty children aged between 15 and 36 months ( M  = 25) with nonsyndromic CP ± CL and typical cognitive development were randomly assigned to a treatment (EMT + PE) or business as usual comparison condition.Participants in the EMT + PE treatment group received 48, 30-min sessions, over a 6-month period. Fidelity of treatment was high across participants.The primary outcome measures were percent consonants correct (PCC), consonant inventory, compensatory articulation errors, and nasal emission. Result : Regression analyses controlling for pre-intervention child characteristics were conducted for PCC and consonant inventory. Intervention was not a significant predictor of post-intervention outcome. Words per minute differentiated the children who benefitted from the intervention from those who did not. Reduction in compensatory errors and nasal emission occurred in both groups but to a greater degree in the EMT + PE group. Conclusion : EMT + PE is a promising early speech intervention for young children with CP ± L, especially for children with higher rates of word use.",2020,Reduction in compensatory errors and nasal emission occurred in both groups but to a greater degree in the EMT + PE group.,"['Thirty children aged between 15 and 36 months ( M \u2009=\u200925) with nonsyndromic CP\u2009±\u2009CL and typical cognitive development', 'toddlers with cleft palate with or without cleft lip (CP\u2009±\u2009L', 'young children with cleft palate', 'Participants ']","['treatment (EMT\u2009+\u2009PE) or business as usual comparison condition', 'EMT\u2009+\u2009PE', 'naturalistic communication intervention, Enhanced Milieu Teaching with Phonological Emphasis (EMT\u2009+\u2009PE', 'naturalistic intervention']","['compensatory errors and nasal emission', 'percent consonants correct (PCC), consonant inventory, compensatory articulation errors, and nasal emission']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0008925', 'cui_str': 'Cleft Palate'}, {'cui': 'C0008924', 'cui_str': 'Harelip'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013963', 'cui_str': 'Emergency Medicine Technicians'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0233929', 'cui_str': 'Emission (finding)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",30.0,0.0718014,Reduction in compensatory errors and nasal emission occurred in both groups but to a greater degree in the EMT + PE group.,"[{'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Scherer', 'Affiliation': 'Department of Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Ann P', 'Initials': 'AP', 'LastName': 'Kaiser', 'Affiliation': 'Department of Special Education, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Frey', 'Affiliation': 'Department of Special Education and Disability Studies, The George Washington University, Washington, DC, USA, and.'}, {'ForeName': 'Hope Sparks', 'Initials': 'HS', 'LastName': 'Lancaster', 'Affiliation': 'Department of Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Lien', 'Affiliation': 'Department of Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Megan Y', 'Initials': 'MY', 'LastName': 'Roberts', 'Affiliation': 'School of Communication, Northwestern University, Evanston, IL, USA.'}]",International journal of speech-language pathology,['10.1080/17549507.2019.1702719']
394,32163182,The effect of computer game playing habits of university students on their sleep states.,"OBJECTIVE


The aim of this study is to evaluate the effect of computer game playing habits of university students on their sleep states.
DESIGN AND METHODS


The study was conducted cross-sectionally with the online survey method.
FINDING


In this study, it was determined that the students who played games for an average of ≥2 hours per day had later bedtime and later wake-up time, poorer sleep quality, and higher daytime sleepiness. It was found that as the level of game addiction increased, sleep quality decreased, the severity of daytime sleepiness increased, and the wake-up time shifted to a later time.
PRACTICE IMPLICATIONS


Nurses should develop effective intervention strategies involving technology management and sleep hygiene studies to reduce game-playing time of students.",2020,"It was found that as the level of game addiction increased, sleep quality decreased, the severity of daytime sleepiness increased, and the wake-up time shifted to a later time.
",['university students on their sleep states'],['computer game playing habits'],"['sleep quality', 'later bedtime and later wake-up time, poorer sleep quality, and higher daytime sleepiness', 'severity of daytime sleepiness']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0161341,"It was found that as the level of game addiction increased, sleep quality decreased, the severity of daytime sleepiness increased, and the wake-up time shifted to a later time.
","[{'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Akçay', 'Affiliation': 'Public Health Nursing, Military of National Defense, Basınevler/Ankara, Turkey.'}, {'ForeName': 'Bülent Devrim', 'Initials': 'BD', 'LastName': 'Akçay', 'Affiliation': 'Ruh Sağlığı ve Hastalıkları Bölümü, Ministry of Health Gülhane Education Research Hospital, Basınevler/Ankara, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12497']
395,31319426,[Effectiveness of Upper Body Compression Garments Under Competitive Conditions: A Randomised Crossover Study with Elite Canoeists with an Additional Case Study].,"This study aimed to investigate the effects of upper body compression garments on performance changes in elite canoeists. A total of 23 elite athletes from the German Canoe Federation (6 women and 17 men) were recruited. On a regatta lake, the athletes completed a 1650-m test track with their competition or training boats and paddles. The athletes were randomised into two groups and performed the test track with and without upper body compression garments. Besides split and end times, capillary blood lactate concentrations were assessed. For statistical analysis, an effect-based approach (""Magnitude-Based Inferences"") and an additional case study were conducted. For this purpose, the mean and individual effects were examined in relation to the smallest worthwhile changes. On average, the effect-based approach shows that upper body compression garments do not lead to clear changes in performance. The changes in lactate concentrations were clear, but were considered trivial. In contrast to the average statistical analysis, the results of the case study demonstrate that upper body compression garments lead to an improved performance in 13.0 % and a worsened performance in 4.4 % of athletes. Additionally, a decreased lactate concentration was found in 4.4 % and an increased lactate concentration in 17.4 % of athletes. Our study shows that, on average, upper body compression garments have no effects on the performance and lactate concentration of highly trained elite canoeists. In individual cases, however, there are beneficial as well as harmful effects that may have practical relevant consequences for elite athletes.",2020,"On average, the effect-based approach shows that upper body compression garments do not lead to clear changes in performance.","['23 elite athletes from the German Canoe Federation (6 women and 17 men', 'elite canoeists', 'Elite', 'elite athletes']","['upper body compression garments', 'Upper Body Compression Garments Under Competitive Conditions', 'test track with and without upper body compression garments']","['lactate concentration', 'capillary blood lactate concentrations', 'lactate concentrations', 'performance and lactate concentration']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0522726', 'cui_str': 'Canoeing'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C2985539', 'cui_str': 'Compression garment (physical object)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0040594', 'cui_str': 'Track'}]","[{'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood (substance)'}]",,0.0212832,"On average, the effect-based approach shows that upper body compression garments do not lead to clear changes in performance.","[{'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Grim', 'Affiliation': 'Klinikum Osnabrück GmbH, Klinik für Orthopädie, Unfall- und Handchirurgie, Osnabrück, Deutschland.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hotfiel', 'Affiliation': 'Klinikum Osnabrück GmbH, Klinik für Orthopädie, Unfall- und Handchirurgie, Osnabrück, Deutschland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Engelhardt', 'Affiliation': 'Klinikum Osnabrück GmbH, Klinik für Orthopädie, Unfall- und Handchirurgie, Osnabrück, Deutschland.'}, {'ForeName': 'Dennis B', 'Initials': 'DB', 'LastName': 'Drieschner', 'Affiliation': 'Trainerakademie Köln des DOSB, Köln.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Willscheid', 'Affiliation': 'Schulthess Klinik Zürich, Abteilung Sportmedizin, Zürich, Schweiz.'}, {'ForeName': 'Matthias W', 'Initials': 'MW', 'LastName': 'Hoppe', 'Affiliation': 'Klinikum Osnabrück GmbH, Klinik für Orthopädie, Unfall- und Handchirurgie, Osnabrück, Deutschland.'}]",Sportverletzung Sportschaden : Organ der Gesellschaft fur Orthopadisch-Traumatologische Sportmedizin,['10.1055/a-0895-2317']
396,32162287,Fork-tip needle biopsy versus fine-needle aspiration in endoscopic ultrasound-guided sampling of solid pancreatic masses: a randomized crossover study.,"BACKGROUND


A novel fork-tip fine-needle biopsy (FNB) needle has recently been introduced for endoscopic ultrasound (EUS)-guided sampling. The aim of this study was to compare the performance of fork-tip FNB histology and standard fine-needle aspiration (FNA) cytology in the diagnosis of solid pancreatic masses.
METHODS


A randomized crossover study was performed in patients referred for EUS-guided sampling. Three passes were taken with each needle in a randomized order. Only samples reported as diagnostic of malignancy were considered positive. The primary end point was the sensitivity of diagnosis of malignancy. Secondary end points included the amount of sample obtained, ease of diagnosis, duration of tissue sampling, pathologist viewing time, and cost.
RESULTS


108 patients were recruited. Median age was 69 years (range 30 - 87) and 57 were male; 85.2 % had a final diagnosis of malignancy. There were statistically significant differences in sensitivity (82 % [95 % confidence interval (CI) 72 % to 89 %] vs. 71 % [95 %CI 60 % to 80 %]), accuracy (84 % [95 %CI 76 % to 91 %] vs. 75 % [95 %CI 66 % to 83 %]), proportion graded as a straightforward diagnosis (69 % [95 %CI 60 % to 78 %] vs. 51 % [95 %CI 41 % to 61 %]), and median pathology viewing time (188 vs. 332 seconds) ( P  < 0.001) between FNB and FNA needles, respectively. There was no significant difference in cost between an FNB or FNA strategy.
CONCLUSION


The diagnostic performance of the fork-tip FNB needle was significantly better than that of FNA; it was associated with ease of diagnosis, shorter pathological viewing times, and was cost neutral.",2020,"The diagnostic performance of the fork-tip FNB needle was significantly better than that of FNA; it was associated with ease of diagnosis, shorter pathological viewing times, and was cost neutral.","['Median age was 69 years (range 30\u200a-\u200a87) and 57 were male; 85.2\u200a% had a final diagnosis of malignancy', '108 patients were recruited', 'patients referred for EUS-guided sampling']","['Fork-tip needle biopsy versus fine-needle aspiration', 'endoscopic ultrasound-guided sampling of solid pancreatic masses', 'fork-tip FNB histology and standard fine-needle aspiration (FNA) cytology', 'FNA', 'novel fork-tip fine-needle biopsy ']","['amount of sample obtained, ease of diagnosis, duration of tissue sampling, pathologist viewing time, and cost', 'sensitivity of diagnosis of malignancy', 'median pathology viewing time', 'accuracy', 'sensitivity', 'straightforward diagnosis']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332144', 'cui_str': 'Final diagnosis (discharge) (contextual qualifier) (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0546910', 'cui_str': 'Fork (physical object)'}, {'cui': 'C0005560', 'cui_str': 'Biopsy, Needle'}, {'cui': 'C1510483', 'cui_str': 'Fine-Needle Aspiration'}, {'cui': 'C0376443', 'cui_str': 'Ultrasonography, Endoscopic'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy (procedure)'}]","[{'cui': 'C1277697', 'cui_str': 'Sample obtained'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0334866', 'cui_str': 'Pathologists'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C1272701', 'cui_str': 'Straightforward'}]",108.0,0.0843607,"The diagnostic performance of the fork-tip FNB needle was significantly better than that of FNA; it was associated with ease of diagnosis, shorter pathological viewing times, and was cost neutral.","[{'ForeName': 'Kofi W', 'Initials': 'KW', 'LastName': 'Oppong', 'Affiliation': 'HPB Unit, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Noor L H', 'Initials': 'NLH', 'LastName': 'Bekkali', 'Affiliation': 'Department of Gastroenterology, John Radcliffe Hospital, Oxford University Hospitals NHS Trust, Oxford, United Kingdom.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Leeds', 'Affiliation': 'HPB Unit, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Johnson', 'Affiliation': 'Department of Cellular Pathology, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Manu K', 'Initials': 'MK', 'LastName': 'Nayar', 'Affiliation': 'HPB Unit, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Darné', 'Affiliation': 'Department of Cellular Pathology, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Egan', 'Affiliation': 'Department of Cellular Pathology, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Statsconsultancy, Amersham, United Kingdom.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Haugk', 'Affiliation': 'Department of Cellular Pathology, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}]",Endoscopy,['10.1055/a-1114-5903']
397,32162568,Sensory retraining improves light touch threshold of the paretic hand in chronic stroke survivors: a single-subject A-B design.,"Background:  Light touch, one of the primary and basic sensations, is often neglected in sensory retraining programmes for stroke survivors. Objective:  This study aimed to investigate the effects of sensory retraining on the light touch threshold of the hand, dexterity and upper limb motor function of chronic stroke survivors. Methods:  Five chronic stroke survivors with sensory impairment participated in this single-subject A-B design study. In baseline (A) phase, they only received standard rehabilitation. In the treatment (B) phase, they received a 6-week sensory retraining intervention in addition to standard rehabilitation. In both phases, they were evaluated every 3 days. Light touch threshold, manual dexterity and upper limb motor function were assessed using Semmes-Weinstein Monofilaments, Box-Block Test and Fugl-Meyer Assessment, respectively. Visual analysis, nonparametric Mann-Whitney U test and, c-statistic were used for assessing the changes between phases. Results:  All participants indicated changes in trend or slope of the total score of light touch or both between the two phases. The results of the c-statistic also showed the statistical difference in the total score of light touch between baseline and treatment in all participants ( p  < 0.001). Also, the results of the c-statistic and Mann-Whitney U test supported the difference of manual dexterity and motor function of the upper limb between baseline and treatment in all participants ( p  < 0.001). Conclusion:  Current findings showed that sensory retraining may be an effective adjunctive intervention for improving the light touch threshold of the hand, dexterity and upper limb motor function in chronic stroke survivors.",2020,"Current findings showed that sensory retraining may be an effective adjunctive intervention for improving the light touch threshold of the hand, dexterity and upper limb motor function in chronic stroke survivors.","['stroke survivors', 'Five chronic stroke survivors with sensory impairment participated in this single-subject A-B design study', 'chronic stroke survivors']","['sensory retraining intervention', 'sensory retraining', 'Sensory retraining']","['Light touch threshold, manual dexterity and upper limb motor function', 'total score of light touch', 'Visual analysis, nonparametric Mann-Whitney U test and, c-statistic', 'manual dexterity and motor function of the upper limb']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0556505', 'cui_str': 'Sensory retraining (regime/therapy)'}]","[{'cui': 'C0423553', 'cui_str': 'Light touch, function (observable entity)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}]",5.0,0.037514,"Current findings showed that sensory retraining may be an effective adjunctive intervention for improving the light touch threshold of the hand, dexterity and upper limb motor function in chronic stroke survivors.","[{'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Hejazi-Shirmard', 'Affiliation': 'Rehabilitation Research Center, Department of Occupational Therapy, School of Rehabilitation Sciences, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Ghorban', 'Initials': 'G', 'LastName': 'Taghizadeh', 'Affiliation': 'Rehabilitation Research Center, Department of Occupational Therapy, School of Rehabilitation Sciences, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Azad', 'Affiliation': 'Rehabilitation Research Center, Department of Occupational Therapy, School of Rehabilitation Sciences, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Lajevardi', 'Affiliation': 'Rehabilitation Research Center, Department of Occupational Therapy, School of Rehabilitation Sciences, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Rassafiani', 'Affiliation': 'Occupational Therapy Department, Faculty of Allied Health Sciences, Kuwait University, Kuwait City, Kuwait.'}]",Somatosensory & motor research,['10.1080/08990220.2020.1736021']
398,32026435,"Multimodal pain control in adolescent posterior spinal fusion patients: a double-blind, randomized controlled trial to validate the effect of gabapentin on postoperative pain control, opioid use, and patient satisfaction.","STUDY DESIGN


Prospective double-blind, randomized controlled trial.
OBJECTIVES


The objective of this study was to validate the efficacy of gabapentin as part of a multimodal pain regimen in a double-blind, randomized controlled trial for patients aged 10-19 years with idiopathic scoliosis undergoing posterior spinal fusion. Perioperative pain management represents a challenge for patients undergoing surgical correction of adolescent spinal deformity. Gabapentin has been shown to decrease postoperative pain and opioid use after spine surgery, but it has not yet been investigated as part of a multimodal pain regimen intended to decrease the perioperative use of opioids.
METHODS


Fifty patients were randomized to receive gabapentin or placebo pre- and postoperatively in addition to a standardized medication regime including scheduled ketorolac and as-needed acetaminophen, hydromorphone, and oxycodone. Patients were monitored in the pre-, peri-, and postoperative periods for pain levels, medication dosing, side effects, adverse events, hospitalization length of stay, and parent satisfaction.
RESULTS


There were statistically significant decreases in early postoperative pain scores and opioid use as well as total postoperative opioid use for the treatment group relative to controls. There were no statistically significant differences in adverse events, medication side effects, or hospitalization length. Parents of patients in both groups were very satisfied with the pain control provided to their children.
CONCLUSIONS


This randomized controlled trial demonstrates that pre- and postoperative administration of gabapentin as part of a multimodal pain management protocol significantly decreases both opioid use and visual analog pain scales in the first two postoperative days after posterior spinal fusion for adolescent idiopathic scoliosis. Gabapentin should be considered as a standard medication for perioperative pain control in this patient population.
LEVEL OF EVIDENCE


Level I.",2020,There were statistically significant decreases in early postoperative pain scores and opioid use as well as total postoperative opioid use for the treatment group relative to controls.,"['Fifty patients', 'patients undergoing surgical correction of adolescent spinal deformity', 'adolescent idiopathic scoliosis', 'adolescent posterior spinal fusion patients', 'patients aged 10-19\xa0years with idiopathic scoliosis undergoing posterior spinal fusion']","['gabapentin or placebo', 'Multimodal pain control', 'ketorolac and as-needed acetaminophen, hydromorphone, and oxycodone', 'Gabapentin', 'Perioperative pain management', 'gabapentin']","['opioid use and visual analog pain scales', 'pre-, peri-, and postoperative periods for pain levels, medication dosing, side effects, adverse events, hospitalization length of stay, and parent satisfaction', 'early postoperative pain scores and opioid use as well as total postoperative opioid use', 'adverse events, medication side effects, or hospitalization length', 'postoperative pain control, opioid use, and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0575157', 'cui_str': 'Deformity of spine (finding)'}, {'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis (disorder)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0037935', 'cui_str': 'Spinal Fusion'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0595995', 'cui_str': 'Idiopathic scoliosis (disorder)'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0042815', 'cui_str': 'Visual Analog Pain Scale'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2364092', 'cui_str': 'Medication side effects present'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",50.0,0.565227,There were statistically significant decreases in early postoperative pain scores and opioid use as well as total postoperative opioid use for the treatment group relative to controls.,"[{'ForeName': 'Devon E', 'Initials': 'DE', 'LastName': 'Anderson', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Oregon Health and Science University, 3181 SW Sam Jackson Park Road, OP31, Portland, OR, 97239-3098, USA.'}, {'ForeName': 'Nicholas T', 'Initials': 'NT', 'LastName': 'Duletzke', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Oregon Health and Science University, 3181 SW Sam Jackson Park Road, OP31, Portland, OR, 97239-3098, USA.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Pedigo', 'Affiliation': ""Department of Pediatric Anaesthesiology, Doernbecher Children's Hospital, Oregon Health and Science University, 3181 SW Sam Jackson Park Road, Portland, OR, 97239-3098, USA.""}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Halsey', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Oregon Health and Science University, 3181 SW Sam Jackson Park Road, OP31, Portland, OR, 97239-3098, USA. halseyma@ohsu.edu.'}]",Spine deformity,['10.1007/s43390-020-00038-z']
399,32155773,Effects of a Physical Activity Intervention on Physical Fitness of schoolchildren: The Enriched Sport Activity Program.,"Background:  Physical fitness in youth is a predictor of health in adulthood. The main objective of the present study was to understand if an enriched sport activity program could increase physical fitness in a population of schoolchildren.  Methods:  In a sample of 672 children aged 10.0 ± 1.90 years, different motor skills were tested by the 1 kg and 3 kg ball throw (BT), the standing broad jump (SBJ), the 30 m sprint (30mS), the leger shuttle run (LSR), the illinois agility test (IGT), and the quadruped test (QT). Within the controlled-trial, the intervention group (ESA) underwent an additional warm-up protocol, which included cognitive enhancing elements, for 14 weeks while the control group continued with ordinary exercise activity.  Results:  A significant increase was present regarding the 1 kg and 3 kg BT, the SBJ, the 30mS, and the IGT, while no significant difference was shown regarding the QT and the LSR in the ESA group between pre and post intervention. In the control group, no differences were present for any test except for the QT and the LSR post-test.  Conclusion:  A 14-week structured physical intervention had moderate effects regarding throwing, jumping, sprinting, and agility in a sample of schoolchildren.",2020,"In the control group, no differences were present for any test except for the QT and the LSR post-test.  ","['schoolchildren', 'population of schoolchildren', '672 children aged 10.0 ± 1.90 years, different motor skills were tested by the 1 kg and 3 kg ball throw (BT), the standing broad jump (SBJ), the 30 m sprint (30mS), the']","['intervention group (ESA) underwent an additional warm-up protocol, which included cognitive enhancing elements, for 14 weeks while the control group continued with ordinary exercise activity', 'Physical Activity Intervention', 'enriched sport activity program', 'leger shuttle run (LSR), the illinois agility test (IGT), and the quadruped test (QT']",['physical fitness'],"[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0560512', 'cui_str': 'Does throw (finding)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",672.0,0.0378147,"In the control group, no differences were present for any test except for the QT and the LSR post-test.  ","[{'ForeName': 'Ewan', 'Initials': 'E', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychological, Pedagogical, Educational Science and Human Movement, University of Palermo, 90144 Palermo, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Bianco', 'Affiliation': 'Department of Psychological, Pedagogical, Educational Science and Human Movement, University of Palermo, 90144 Palermo, Italy.'}, {'ForeName': 'Garden', 'Initials': 'G', 'LastName': 'Tabacchi', 'Affiliation': 'Department of Psychological, Pedagogical, Educational Science and Human Movement, University of Palermo, 90144 Palermo, Italy.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Marques da Silva', 'Affiliation': 'CIEQV-Life Quality Research Centre, Escola Superior de Desporto de Rio Maior-IPSANTAREM, Av. Dr. Mário Soares, 20413 RIO Maior, Portugal.'}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Loureiro', 'Affiliation': 'CIEQV-Life Quality Research Centre, Escola Superior de Desporto de Rio Maior-IPSANTAREM, Av. Dr. Mário Soares, 20413 RIO Maior, Portugal.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Basile', 'Affiliation': 'University of Palermo Sport Center (CUS Palermo), Via Altofonte, 80, 90129 Palermo, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Giaccone', 'Affiliation': 'University of Palermo Sport Center (CUS Palermo), Via Altofonte, 80, 90129 Palermo, Italy.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Sturm', 'Affiliation': 'Department of School of Sport and Health Sciences, Professorship of Educational Science in Sport and Health, Technical University of Munich, Uptown Munich Campus D, Georg-Brauchle-Ring 60/62, 80992 Munich, Germany.'}, {'ForeName': 'Fatma Neşe', 'Initials': 'FN', 'LastName': 'Şahin', 'Affiliation': 'Department of Sport and Health, Faculty of Sport Sciences, Ankara University, Golbaşı Yerleşkesi Spor Bilimleri Fakültesi, Golbaşı, 06830 Ankara, Turkey.'}, {'ForeName': 'Özkan', 'Initials': 'Ö', 'LastName': 'Güler', 'Affiliation': 'Department of Sport and Health, Faculty of Sport Sciences, Ankara University, Golbaşı Yerleşkesi Spor Bilimleri Fakültesi, Golbaşı, 06830 Ankara, Turkey.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Gómez-López', 'Affiliation': 'Department of Physical Activity and Sport, Faculty of Sports Sciences, University of Murcia, Calle Argentina, s/n., 30720 Murcia, Spain.'}, {'ForeName': 'Guillermo F', 'Initials': 'GF', 'LastName': 'López Sánchez', 'Affiliation': 'Department of Physical Activity and Sport, Faculty of Sports Sciences, University of Murcia, Calle Argentina, s/n., 30720 Murcia, Spain.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Pajaujiene', 'Affiliation': 'Department of Coaching Science, Lithuanian Sports University, Sporto 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Ilona Judita', 'Initials': 'IJ', 'LastName': 'Zuoziene', 'Affiliation': 'Department of Coaching Science, Lithuanian Sports University, Sporto 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Ante', 'Initials': 'A', 'LastName': 'Rada', 'Affiliation': 'Faculty of Kinesiology, University of Split, Teslina 6, 21000 Split, Croatia.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Alesi', 'Affiliation': 'Department of Psychological, Pedagogical, Educational Science and Human Movement, University of Palermo, 90144 Palermo, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Palma', 'Affiliation': 'Department of Psychological, Pedagogical, Educational Science and Human Movement, University of Palermo, 90144 Palermo, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17051723']
400,32157334,Distribution of Prevalent and Incident Vertebral Fractures and Their Association with Bone Mineral Density in Postmenopausal Women in the Teriparatide Versus Risedronate VERO Clinical Trial.,"Vertebral fractures (VFx) occur most frequently in the mid-thoracic and thoraco-lumbar regions, which experience the highest mechanical loading along the spine. The prevalence and incidence of VFx by their location and severity, and their relationship with bone mineral density (BMD), are seldom reported in randomized clinical trial cohorts. The VERO trial randomized 1360 postmenopausal women with at least two moderate or one severe VFx to receive either teriparatide or risedronate for up to 24 months. In this post hoc analysis, we describe the centrally read distribution and severity of prevalent and incident VFx, and the association of their location with the baseline BMD. At baseline, 21.4% of all evaluable vertebral bodies had a prevalent VFx; most commonly at L 1 , T 12 , L 2  and T 11  (38.5%, 37.4%, 25.3% and 23.5% of patients, respectively). Patients with prevalent VFx only at T 12 /L 1  showed a higher baseline BMD compared to patients with VFx at other levels. At month 24, 100 patients had 126 incident VFx (teriparatide: 35; risedronate: 91). The most frequent incident VFx occurred at T 12  (n = 17, 1.6% of patients), followed by L 1  and T 11  (n = 14, 1.3% both). The frequency of incident VFx was lower at all vertebral levels in patients given teriparatide. These results confirm prior reports that VFx occurs more frequently at mid-thoracic and thoraco-lumbar regions of the spine. Patients with these VFx locations have higher BMD than those who fracture at other sites, suggesting a role for mechanical stress in the etiology of VFx. Teriparatide is superior to risedronate in the prevention of VFx at these common fracture locations.Trial registration ClinicalTrials.gov Identifier: NCT01709110.",2020,Patients with prevalent VFx only at T 12 /L 1  showed a higher baseline BMD compared to patients with VFx at other levels.,"['1360 postmenopausal women with at least two moderate or one severe VFx to receive either', 'Postmenopausal Women', 'for up to 24\xa0months', '100 patients had 126 incident VFx (teriparatide: 35']","['teriparatide', 'Teriparatide', 'risedronate', 'teriparatide or risedronate']","['frequency of incident VFx', 'incident VFx', 'baseline BMD', 'BMD', 'bone mineral density (BMD', 'Vertebral fractures (VFx']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0246719', 'cui_str': 'Risedronate'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",1360.0,0.0650683,Patients with prevalent VFx only at T 12 /L 1  showed a higher baseline BMD compared to patients with VFx at other levels.,"[{'ForeName': 'Piet', 'Initials': 'P', 'LastName': 'Geusens', 'Affiliation': 'Department of Internal Medicine, Subdivision of Rheumatology, Maastricht University Medical Center, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands. piet.geusens@scarlet.be.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Kendler', 'Affiliation': 'Department of Medicine (Endocrinology), University of British Columbia, Vancouver, BC, V5Z 4E1, Canada.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Fahrleitner-Pammer', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'López-Romero', 'Affiliation': 'Department of Medical Research, Eli Lilly and Company, Avda. de la Industria 30, 28108, Alcobendas (Madrid), Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Marin', 'Affiliation': 'Department of Medical Research, Eli Lilly and Company, Avda. de la Industria 30, 28108, Alcobendas (Madrid), Spain.'}]",Calcified tissue international,['10.1007/s00223-020-00683-6']
401,31501112,Intensive and standard group-based treatment for persons with social communication difficulties after an acquired brain injury: study protocol for a randomised controlled trial.,"INTRODUCTION


Social communication difficulties (SCDs) occur frequently after an acquired brain injury (ABI) and have disabling consequences, but effective interventions are scant. Group Interactive Structured Treatment (GIST) is a holistic group treatment targeting SCD that has received empirical support.
OBJECTIVE


To determine the efficacy of two GIST protocols, standard GIST and a newly developed intensive GIST, comparing standard GIST results to a wait-list control group (WL), as well as to intensive GIST received by participants following WL. The within subject results for WL and intensive GIST will also be examined.
METHODS AND ANALYSIS


Sixty adults (18-75 years) with SCD after ABI will be recruited for this randomised controlled trial. Standard GIST (n=30) will be delivered via outpatient sessions for 2.5 hours once per week for 12 weeks, plus one initial orientation session. Participants will be assessed at preintervention and postintervention and at 3-month and 6-month follow-ups (T1-T4). Intensive GIST (n=30) participants will be admitted to an inpatient rehabilitation unit for 4 weeks (two times 3 days/week, two times 4 days/week) and receive full-day sessions each week. Those participants will complete four assessments (T1-T4) in 12-week intervals as part of WL, assessments preintensive and postintensive GIST and at 3-month and 6-month follow-ups (T4-T7). The primary outcome measure is the La Trobe Questionnaire (self-report). Secondary outcome measures include the Profile of Pragmatic Impairment in Communication, a test of emotion recognition, the Goal Attainment Scale and questionnaires addressing social, emotional and cognitive functions, self-efficacy and quality of life.
ETHICS AND DISSEMINATION


Results will be communicated through international, peer-reviewed and popular science journals and presentations at scientific conferences. The study is approved by the Regional Committees for Medical and Health Research Ethics Norway (2017/1360). The trial will be conducted in accordance with the Declaration of Helsinki and reported in accordance with the Consolidated Standards of Reporting Trials 2010 statement and Standard Protocol Items: Recommendations for Interventional Trials recommendations.
TRIAL REGISTRATION NUMBER


NCT03636399.",2019,"Secondary outcome measures include the Profile of Pragmatic Impairment in Communication, a test of emotion recognition, the Goal Attainment Scale and questionnaires addressing social, emotional and cognitive functions, self-efficacy and quality of life.
","['Sixty adults (18-75 years) with SCD', 'persons with social communication difficulties after an acquired brain injury']","['Group Interactive Structured Treatment (GIST', 'Intensive and standard group-based treatment', 'Intensive GIST', 'GIST protocols, standard GIST', 'Standard GIST']","['Profile of Pragmatic Impairment in Communication, a test of emotion recognition, the Goal Attainment Scale and questionnaires addressing social, emotional and cognitive functions, self-efficacy and quality of life', 'La Trobe Questionnaire (self-report']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal Stromal Tumors'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0034380'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",60.0,0.0891933,"Secondary outcome measures include the Profile of Pragmatic Impairment in Communication, a test of emotion recognition, the Goal Attainment Scale and questionnaires addressing social, emotional and cognitive functions, self-efficacy and quality of life.
","[{'ForeName': 'Silje Merethe', 'Initials': 'SM', 'LastName': 'Hansen', 'Affiliation': 'Department of Special Needs Education, University of Oslo, Oslo, Norway s.m.hansen@isp.uio.no.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stubberud', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Hjertstedt', 'Affiliation': 'Sunnaas Rehabilitation Hospital, Akershus, Norway.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Kirmess', 'Affiliation': 'Department of Special Needs Education, University of Oslo, Oslo, Norway.'}]",BMJ open,['10.1136/bmjopen-2019-029392']
402,31968571,Circulating Ionized Magnesium: Comparisons with Circulating Total Magnesium and the Response to Magnesium Supplementation in a Randomized Controlled Trial.,"Ionized Mg (iMg) is considered the biologically active fraction of circulating total Mg (tMg). It is possible that iMg may be a more physiologically relevant marker than tMg. Using data from a double-blind pilot randomized controlled trial, we tested (1) whether oral Mg supplementation will increase iMg concentrations compared with placebo and (2) the relationship between iMg and tMg at baseline. Additionally, we evaluated the agreement between iMg measured in fresh whole blood versus stored samples. A total of fifty-nine participants were randomized 1:1 to oral Mg supplementation (400 mg/day, Mg Oxide) or placebo for 10 weeks. Fasting blood samples were obtained at baseline and follow-up. The analysis used linear regression and an intent-to-treat approach. Participants were generally healthy, the mean age was 62, and 73% were female. The baseline iMg and tMg were modestly and positively associated (r = 0.50). The ratio of baseline iMg to tMg was 64%. The mean supplement effect on iMg was 0.03 mmol/L (95% CI:0.01, 0.05) for Mg supplementation versus placebo. The supplement effect on iMg was not statistically significantly different according to baseline iMg status (above/below median). Compared to fresh blood, iMg was consistently higher in refrigerated and frozen samples by 0.14 and 0.20 mmol/L, respectively. In this relatively healthy adult population, Mg supplementation over 10 weeks resulted in increased iMg concentrations. Whether iMg is a more appropriate measure of Mg status than tMg, and the public health or clinical utility of measuring iMg remains to be determined.",2020,The supplement effect on iMg was not statistically significantly different according to baseline iMg status (above/below median).,"['Participants were generally healthy, the mean age was 62, and 73% were female', 'A total of fifty-nine participants']","['Magnesium Supplementation', 'oral Mg supplementation', 'placebo', 'Ionized Mg (iMg', 'oral Mg supplementation (400 mg/day, Mg Oxide) or placebo']","['baseline iMg and tMg', 'Fasting blood samples', 'iMg concentrations']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}]","[{'cui': 'C1096534', 'cui_str': 'Providing magnesium based on suboptimal food or fluid intake, iatrogenic deficiency or medical diagnosis. (Source: IDNT Reference Manual, edition 4; ISBN #978-0-88091-467-3)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0030015', 'cui_str': 'Oxides'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",59.0,0.46985,The supplement effect on iMg was not statistically significantly different according to baseline iMg status (above/below median).,"[{'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Rooney', 'Affiliation': 'Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, MN 55454, USA, harna001@umn.edu (L.H.).'}, {'ForeName': 'Kyle D', 'Initials': 'KD', 'LastName': 'Rudser', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN 55455, USA, rudser@umn.edu.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Alonso', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA, alvaro.alonso@emory.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Harnack', 'Affiliation': 'Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, MN 55454, USA, harna001@umn.edu (L.H.).'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Saenger', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Hennepin Healthcare, Minneapolis, MN 55415, USA, amy.saenger@hcmed.org.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Lutsey', 'Affiliation': 'Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, MN 55454, USA, harna001@umn.edu (L.H.).'}]",Nutrients,['10.3390/nu12010263']
403,29470854,The Cost-Effectiveness of Screening in the Community to Reduce Osteoporotic Fractures in Older Women in the UK: Economic Evaluation of the SCOOP Study.,"The SCOOP study was a two-arm randomized controlled trial conducted in the UK in 12,483 eligible women aged 70 to 85 years. It compared a screening program using the FRAX® risk assessment tool in addition to bone mineral density (BMD) measures versus usual management. The SCOOP study found a reduction in the incidence of hip fractures in the screening arm, but there was no evidence of a reduction in the incidence of all osteoporosis-related fractures. To make decisions about whether to implement any screening program, we should also consider whether the program is likely to be a good use of health care resources, ie, is it cost-effective? The cost per gained quality adjusted life year of screening for fracture risk has not previously been demonstrated in an economic evaluation alongside a clinical trial. We conducted a ""within trial"" economic analysis alongside the SCOOP study from the perspective of a national health payer, the UK National Health Service (NHS). The main outcome measure in the economic analysis was the cost per quality adjusted life year (QALY) gained over a 5-year time period. We also estimated cost per osteoporosis-related fracture prevented and the cost per hip fracture prevented. The screening arm had an average incremental QALY gain of 0.0237 (95% confidence interval -0.0034 to 0.0508) for the 5-year follow-up. The incremental cost per QALY gained was £2772 compared with the control arm. Cost-effectiveness acceptability curves indicated a 93% probability of the intervention being cost-effective at values of a QALY greater than £20,000. The intervention arm prevented fractures at a cost of £4478 and £7694 per fracture for osteoporosis-related and hip fractures, respectively. The current study demonstrates that a systematic, community-based screening program of fracture risk in older women in the UK represents a highly cost-effective intervention. © 2018 The Authors. Journal of Bone and Mineral Research Published by Wiley Periodicals, Inc.",2018,"Cost-effectiveness acceptability curves indicated a 93% probability of the intervention being cost-effective at values of a QALY greater than £20,000.","['older women in the UK', 'Older Women in the UK', '12,483 eligible women aged 70 to 85 years']",['community-based screening program'],"['cost per quality adjusted life year (QALY) gained over a 5-year time period', 'Osteoporotic Fractures', 'average incremental QALY gain', 'bone mineral density (BMD) measures', 'incidence of hip fractures', 'Cost-Effectiveness', 'Cost-effectiveness acceptability curves', 'incremental cost per QALY gained']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1948053', 'cui_str': 'Time periods (qualifier value)'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic Fractures'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",12483.0,0.0386078,"Cost-effectiveness acceptability curves indicated a 93% probability of the intervention being cost-effective at values of a QALY greater than £20,000.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Turner', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Rebekah Fong Soe', 'Initials': 'RFS', 'LastName': 'Khioe', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Shepstone', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lenaghan', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Gittoes', 'Affiliation': 'Centre for Endocrinology, Diabetes, and Metabolism, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Harvey', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Holland', 'Affiliation': 'Leicester Medical School, Centre for Medicine, University of Leicester, Leicester, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Howe', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'McCloskey', 'Affiliation': 'Mellanby Centre for Bone Research, Centre for Integrated Research in Musculoskeletal Ageing, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Terence W', 'Initials': 'TW', 'LastName': ""O'Neill"", 'Affiliation': 'National Institute of Health Research Manchester Musculoskeletal BRU, Central Manchester University Hospitals NHS Foundation Trust & Arthritis Research UK Centre for Epidemiology, University of Manchester, Manchester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fordham', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3381']
404,31551378,"Counselling for physical activity, life-space mobility and falls prevention in old age (COSMOS): protocol of a randomised controlled trial.","INTRODUCTION


The most promising way to promote active life years in old age is to promote regular participation in physical activity (PA). Maintaining lower extremity muscle function with good balance has been associated with fewer falls and the need of help from others. This article describes the design and intervention of a randomised controlled trial (RCT) investigating the effectiveness of a health and PA counselling programme on life-space mobility and falls rates in community-dwelling older adults at the Health Kiosk and/or Service Centre.
METHODS AND ANALYSIS


Community-dwelling men and women (n=450) aged 65 years and over with early phase mobility limitation will be recruited to a 24-month RCT with a 24-month follow-up. Participants will be randomly allocated into either a health and PA counselling group (intervention) or relaxation group (control intervention). All participants will receive five group specific face-to-face counselling sessions and 11 phone calls. The counselling intervention will include individualised health counselling, strength and balance training, and guidance to regular PA. The control group will receive relaxation exercises. Outcomes will be assessed at baseline, 12, 24 and 48 months. Primary outcomes are average life-space mobility score and falls rates. Life-space mobility will be assessed by a validated questionnaire. Falls rates will be recorded from fall diaries. Secondary outcomes are data on fall-induced injuries and living arrangements, number of fallers, fracture risk, mean level of PA, physical performance, quality of life, mood, cognition, balance confidence and fear of falling. Data will be analysed using the intention-to-treat principle. Cost-effectiveness of the programme will be analysed. Ancillary analyses are planned in participants with greater adherence.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the Ethics Committee of the Tampere University Hospital (R15160). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at international conferences.
TRIAL REGISTRATION


ISRCTN65406039; Pre-results.",2019,Participants will be randomly allocated into either a health and PA counselling group (intervention) or relaxation group (control intervention).,"['old age (COSMOS', 'participants with greater adherence', 'Community-dwelling men and women (n=450) aged 65 years and over with early phase mobility limitation will be recruited to a 24-month RCT with a 24-month follow-up', 'community-dwelling older adults at the Health Kiosk and/or Service Centre']","['counselling intervention will include individualised health counselling, strength and balance training, and guidance to regular PA', 'health and PA counselling programme', 'health and PA counselling group (intervention) or relaxation group (control intervention', 'relaxation exercises']","['life-space mobility and falls rates', 'Cost-effectiveness', 'Falls rates', 'average life-space mobility score and falls rates', 'data on fall-induced injuries and living arrangements, number of fallers, fracture risk, mean level of PA, physical performance, quality of life, mood, cognition, balance confidence and fear of falling', 'Life-space mobility']","[{'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C1565249', 'cui_str': 'Mobility Limitation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0203993', 'cui_str': 'Relaxation exercise (regime/therapy)'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2607857'}, {'cui': 'C0034380'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}]",,0.111214,Participants will be randomly allocated into either a health and PA counselling group (intervention) or relaxation group (control intervention).,"[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Edgren', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland johanna.edgren@jyu.fi.'}, {'ForeName': 'Saija', 'Initials': 'S', 'LastName': 'Karinkanta', 'Affiliation': 'UKK Institute for Health Promotion Research, Tampere, Finland.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Rantanen', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Daly', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Urho M', 'Initials': 'UM', 'LastName': 'Kujala', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Törmäkangas', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Sievänen', 'Affiliation': 'UKK Institute for Health Promotion Research, Tampere, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Kannus', 'Affiliation': 'Department of Orthopaedics and Traumatology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Heinonen', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Sarianna', 'Initials': 'S', 'LastName': 'Sipilä', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Lasse', 'Initials': 'L', 'LastName': 'Kannas', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Rantalainen', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Teittinen', 'Affiliation': 'Research and Development, School of Health and Social Studies, Jyväskylä University of Applied Sciences, Jyväskylä, Finland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Nikander', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}]",BMJ open,['10.1136/bmjopen-2019-029682']
405,31551393,Effects of accelerated versus standard care surgery on the risk of acute kidney injury in patients with a hip fracture: a substudy protocol of the hip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) international randomised controlled trial.,"INTRODUCTION


Inflammation, dehydration, hypotension and bleeding may all contribute to the development of acute kidney injury (AKI). Accelerated surgery after a hip fracture can decrease the exposure time to such contributors and may reduce the risk of AKI.
METHODS AND ANALYSIS


Hip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) is a multicentre, international, parallel-group randomised controlled trial (RCT). Patients who suffer a hip fracture are randomly allocated to either accelerated medical assessment and surgical repair with a goal of surgery within 6 hours of diagnosis or standard care where a repair typically occurs 24 to 48 hours after diagnosis. The primary outcome of this substudy is the development of AKI within 7 days of randomisation. We anticipate at least 1998 patients will participate in this substudy.
ETHICS AND DISSEMINATION


We obtained ethics approval for additional serum creatinine recordings in consecutive patients enrolled at 70 participating centres. All patients provide consent before randomisation. We anticipate reporting substudy results by 2021.
TRIAL REGISTRATION NUMBER


NCT02027896; Pre-results.",2019,Hip fracture,"['1998 patients will participate in this substudy', 'Patients who suffer a hip fracture', 'patients with a hip fracture', 'consecutive patients enrolled at 70 participating centres']","['accelerated medical assessment and surgical repair with a goal of surgery within 6\u2009hours of diagnosis or standard care', 'accelerated versus standard care surgery', 'hip fracture Accelerated surgical TreaTment', 'Accelerated surgical TreaTment']","['development of AKI within 7 days of randomisation', 'Hip fracture']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0521110', 'cui_str': 'Accelerated (contextual qualifier) (qualifier value)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}]",1998.0,0.207812,Hip fracture,"[{'ForeName': 'Flavia K', 'Initials': 'FK', 'LastName': 'Borges', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Devereaux', 'Affiliation': 'Department of Perioperative Medicine, Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Meaghan', 'Initials': 'M', 'LastName': 'Cuerden', 'Affiliation': 'Division of Nephrology, Department of Medicine, Western University, London, Ontario, Canada.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Guerra-Farfán', 'Affiliation': ""Department of Orthopaedic Surgery and Traumatology, University Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Ameen', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alben', 'Initials': 'A', 'LastName': 'Sigamani', 'Affiliation': 'Clinical Research, Narayana Hrudayalaya Limited, Bangalore, India.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Umer', 'Affiliation': 'Department of Orthopaedic Surgery, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Neary', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tiboni', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Tandon', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mmampapatla Thomas', 'Initials': 'MT', 'LastName': 'Ramokgopa', 'Affiliation': 'Department of Orthopaedic Surgery, Chris Hani Baragwanath Academic Hospital, Johannesburg, South Africa.'}, {'ForeName': 'Parag', 'Initials': 'P', 'LastName': 'Sancheti', 'Affiliation': 'Department of Orthopaedic Surgery, Sancheti Institute for Orthopaedics & Rehabilitation, Pune, India.'}, {'ForeName': 'Bobby', 'Initials': 'B', 'LastName': 'John', 'Affiliation': 'Department of Orthopaedic Surgery, Christian Medical College and Hospital Ludhiana, Ludhiana, India.'}, {'ForeName': 'AbdelRahman', 'Initials': 'A', 'LastName': 'Lawendy', 'Affiliation': 'Department of Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Balaguer-Castro', 'Affiliation': ""Department of Orthopaedic Surgery and Traumatology, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Sabadell, Spain.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jenkinson', 'Affiliation': 'Department of Surgery and Institute of Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Ślęczka', 'Affiliation': 'Orthopaedic Department, SPZOZ, Myslenice, Poland.'}, {'ForeName': 'Aamer', 'Initials': 'A', 'LastName': 'Nabi Nur', 'Affiliation': 'Department of Orthopaedic Surgery, Shifa International Hospital, Islamabad, Pakistan.'}, {'ForeName': 'Gavin C A', 'Initials': 'GCA', 'LastName': 'Wood', 'Affiliation': ""Department of Surgery, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Feibel', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'John Stephen', 'Initials': 'JS', 'LastName': 'McMahon', 'Affiliation': 'Department of Surgery, Markham Stouffville Hospital, Markham, Ontario, Canada.'}, {'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Sigamani', 'Affiliation': 'Department of Orthopaedic, Government TD Medical College, Allapuzha, India.'}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'Biccard', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, University of Cape Town, Rondebosch, South Africa.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': 'Department of Anaesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Szczeklik', 'Affiliation': 'Department of Intensive Care and Perioperative Medicine, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Chew Yin', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology, University Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Tomas-Hernandez', 'Affiliation': ""Department of Orthopaedic Surgery and Traumatology, University Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Valsa', 'Initials': 'V', 'LastName': 'Abraham', 'Affiliation': 'Department of Orthopaedic Surgery, Christian Medical College and Hospital Ludhiana, Ludhiana, India.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vincent', 'Affiliation': 'Department of Perioperative Medicine, Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Harvey', 'Affiliation': 'Department of Perioperative Medicine, Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Pettit', 'Affiliation': 'Department of Perioperative Medicine, Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Sontrop', 'Affiliation': 'Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.'}, {'ForeName': 'Amit X', 'Initials': 'AX', 'LastName': 'Garg', 'Affiliation': 'Departments of Health Research Methods, Evidence, and Impact (HEI), McMaster University, Hamilton, Ontario, Canada amit.garg@lhsc.on.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-033150']
406,32150492,A Dose-Ranging Study of Epinephrine Hydrofluroalkane Metered-Dose Inhaler (Primatene ®  MIST) in Subjects with Intermittent or Mild-to-Moderate Persistent Asthma.,"Background:  Two sequential single-dose crossover dose-ranging studies were performed to evaluate the clinical efficacy and safety profile of epinephrine hydrofluroalkane (HFA) metered-dose inhaler (MDI) formulation at various doses in subjects with asthma.  Methods:  In these multicenter, multiarm, double-blinded, or evaluator-blinded studies, subjects were randomized to receive the epinephrine HFA (Primatene ®  MIST HFA) MDI medication at doses ranging from 90 to 440 μg/dose, as well as to a placebo (PLA) control and an active control of epinephrine CFC (chlorofluorocarbon) MDI (Primatene ®  MIST CFC) at 220 μg/inhalation.  Results:  Spirometry testing for FEV1 (Forced Expiratory Volume in one second) demonstrated statistically significant improvements over PLA for epinephrine HFA MDI at all doses above 125 μg, as the amount out of the actuator (i.e., mouthpiece). The efficacy results for epinephrine HFA MDI in the dose range of 125-250 μg were also comparable to epinephrine CFC MDI (220 μg/inh). Safety assessments demonstrated minimal safety concerns for all treatment groups. No notable safety differences were observed between the studied doses of epinephrine HFA MDI and the active control formulation of epinephrine CFC MDI.  Conclusion:  The findings indicate that epinephrine HFA MDI provided clinically significant bronchodilator efficacy with minimal safety concerns in a dose range of 125-250 μg. These findings confirmed the optimal treatment doses of 125-250 μg that were appropriate for use in longer term 12 and 26 week chronic dosing studies of epinephrine HFA MDI for patients with intermittent or mild to moderate persistent asthma. Clinical trials registration number: NCT01025648.",2020,No notable safety differences were observed between the studied doses of epinephrine HFA MDI and the active control formulation of epinephrine CFC MDI.  ,"['subjects with asthma', 'Subjects with Intermittent or Mild-to-Moderate Persistent Asthma', 'patients with intermittent or mild to moderate persistent asthma']","['epinephrine CFC MDI', 'epinephrine HFA (Primatene ®  MIST HFA', 'epinephrine CFC (chlorofluorocarbon) MDI (Primatene MIST CFC', 'Epinephrine Hydrofluroalkane Metered-Dose Inhaler (Primatene ®  MIST', 'epinephrine HFA MDI', 'epinephrine hydrofluroalkane (HFA) metered-dose inhaler (MDI) formulation']","['bronchodilator efficacy', 'minimal safety concerns', 'FEV1 (Forced Expiratory Volume']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0722799', 'cui_str': 'Primatene'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}]","[{'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}]",,0.109318,No notable safety differences were observed between the studied doses of epinephrine HFA MDI and the active control formulation of epinephrine CFC MDI.  ,"[{'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Kerwin', 'Affiliation': 'Clinical Research Institute of Southern Oregon, Medford, Oregon.'}, {'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'Tashkin', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Murphy', 'Affiliation': 'Charleston ENT and Allergy, Charleston, South Carolina.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Bensch', 'Affiliation': 'Allergy, Immunology, and Asthma Medical Group, Inc., Stockton, California.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Marrs', 'Affiliation': 'Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California.'}, {'ForeName': 'Mary Z', 'Initials': 'MZ', 'LastName': 'Luo', 'Affiliation': 'Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California.'}, {'ForeName': 'Jack Y', 'Initials': 'JY', 'LastName': 'Zhang', 'Affiliation': 'Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California.'}]",Journal of aerosol medicine and pulmonary drug delivery,['10.1089/jamp.2019.1558']
407,31422134,Ticagrelor to Reduce Myocardial Injury in Patients With High-Risk Coronary Artery Plaque.,"OBJECTIVES


The goal of this study was to determine whether ticagrelor reduces high-sensitivity troponin I concentrations in patients with established coronary artery disease and high-risk coronary plaque.
BACKGROUND


High-risk coronary atherosclerotic plaque is associated with higher plasma troponin concentrations suggesting ongoing myocardial injury that may be a target for dual antiplatelet therapy.
METHODS


In a randomized, double-blind, placebo-controlled trial, patients with multivessel coronary artery disease underwent coronary  18 F-fluoride positron emission tomography/coronary computed tomography scanning and measurement of high-sensitivity cardiac troponin I. Patients were randomized (1:1) to receive ticagrelor 90 mg twice daily or matched placebo. The primary endpoint was troponin I concentration at 30 days in patients with increased coronary  18 F-fluoride uptake.
RESULTS


In total, 202 patients were randomized to treatment, and 191 met the pre-specified criteria for inclusion in the primary analysis. In patients with increased coronary  18 F-fluoride uptake (120 of 191), there was no evidence that ticagrelor had an effect on plasma troponin concentrations at 30 days (ratio of geometric means for ticagrelor vs. placebo: 1.11; 95% confidence interval: 0.90 to 1.36; p = 0.32). Over 1 year, ticagrelor had no effect on troponin concentrations in patients with increased coronary  18 F-fluoride uptake (ratio of geometric means: 0.86; 95% confidence interval: 0.63 to 1.17; p = 0.33).
CONCLUSIONS


Dual antiplatelet therapy with ticagrelor did not reduce plasma troponin concentrations in patients with high-risk coronary plaque, suggesting that subclinical plaque thrombosis does not contribute to ongoing myocardial injury in this setting. (Dual Antiplatelet Therapy to Reduce Myocardial Injury [DIAMOND]; NCT02110303).",2020,"Over 1 year, ticagrelor had no effect on troponin concentrations in patients with increased coronary  18 F-fluoride uptake (ratio of geometric means: 0.86; 95% confidence interval: 0.63 to 1.17; p = 0.33).
","['Patients', 'patients with high-risk coronary plaque', '202 patients were randomized to treatment, and 191 met the pre-specified criteria for inclusion in the primary analysis', 'patients with established coronary artery disease and high-risk coronary plaque', 'patients with multivessel coronary artery disease underwent coronary  18 F-fluoride positron emission tomography/coronary computed tomography scanning and measurement of high-sensitivity cardiac troponin I. Patients']","['ticagrelor', 'placebo', 'Ticagrelor', 'ticagrelor 90\xa0mg twice daily or matched placebo']","['troponin concentrations', 'Myocardial Injury', 'plasma troponin concentrations', 'troponin I concentration', 'sensitivity troponin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3163568', 'cui_str': 'Ticagrelor 90 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0920210', 'cui_str': 'Troponin I measurement (procedure)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",202.0,0.613089,"Over 1 year, ticagrelor had no effect on troponin concentrations in patients with increased coronary  18 F-fluoride uptake (ratio of geometric means: 0.86; 95% confidence interval: 0.63 to 1.17; p = 0.33).
","[{'ForeName': 'Alastair J', 'Initials': 'AJ', 'LastName': 'Moss', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom. Electronic address: alastairmoss@gmail.com.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Dweck', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Mhairi K', 'Initials': 'MK', 'LastName': 'Doris', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Jack P M', 'Initials': 'JPM', 'LastName': 'Andrews', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Bing', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Rachael O', 'Initials': 'RO', 'LastName': 'Forsythe', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Cartlidge', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Tania A', 'Initials': 'TA', 'LastName': 'Pawade', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Daghem', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Raftis', 'Affiliation': 'Medical Research Council Centre for Inflammation Research, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Williams', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Edwin J R', 'Initials': 'EJR', 'LastName': 'van Beek', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Forsyth', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Steff C', 'Initials': 'SC', 'LastName': 'Lewis', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Lee', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Anoop S V', 'Initials': 'ASV', 'LastName': 'Shah', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Adamson', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Christchurch Heart Institute, University of Otago, Christchurch, New Zealand.'}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2019.05.023']
408,31977010,Validation of European Society of Cardiology pre-test probabilities for obstructive coronary artery disease in suspected stable angina.,"AIMS


To assess contemporary pre-test probability estimates for obstructive coronary artery disease in patients with stable chest pain.
METHODS AND RESULTS


In a substudy of a multicentre randomised controlled trial, we compared 2019 European Society of Cardiology (ESC)-endorsed pre-test probabilities with observed prevalence of obstructive coronary artery disease on computed tomography coronary angiography (CTCA). We assessed associations between pre-test probability, 5-year coronary heart disease death or non-fatal myocardial infarction and study intervention (standard care versus CTCA).The study population consisted of 3755 patients (30-75 years, 46% women) with a median pre-test probability of 11% of whom 1622 (43%) had a pre-test probability >15%. In those who underwent CTCA (n = 1613), the prevalence of obstructive disease was 22%. When divided into deciles of pre-test probability, the observed disease prevalence was similar but higher than the corresponding median pre-test probability (median difference 2.3 [1.3-5.6]%). There were more clinical events in patients with a pre-test probability >15% compared to those at 5-15% and <5% (4.1%, 1.5% and 1.4% respectively, p < 0.001). Across the total cohort, fewer clinical events occurred in patients who underwent CTCA, with the greatest difference in those with a pre-test probability >15% (2.8% vs 5.3%, log rank p = 0.01), although this interaction was not statistically significant on multivariable modelling.
CONCLUSION


The updated 2019 ESC guideline pre-test probability recommendations tended to slightly underestimate disease prevalence in our cohort. Pre-test probability is a powerful predictor of future coronary events and helps select those who may derive the greatest absolute benefit from CTCA.",2020,"There were more clinical events in patients with a pre-test probability >15% compared to those at 5-15% and <5% (4.1%, 1.5% and 1.4% respectively, p < 0.001).","['obstructive coronary artery disease in suspected stable angina', '3755 patients (30-75 years, 46% women) with a median pre-test probability of 11% of whom 1622 (43%) had a pre-test probability >15', 'patients with stable chest pain', '2019 European Society of Cardiology (ESC)-endorsed pre-test probabilities with observed prevalence of obstructive coronary artery disease on computed tomography coronary angiography (CTCA']",['CTCA'],"['clinical events', 'pre-test probability, 5-year coronary heart disease death or non-fatal myocardial infarction', 'prevalence of obstructive disease']","[{'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0340288', 'cui_str': 'Angina Pectoris, Stable'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}]",[],"[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",3755.0,0.0861506,"There were more clinical events in patients with a pre-test probability >15% compared to those at 5-15% and <5% (4.1%, 1.5% and 1.4% respectively, p < 0.001).","[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Bing', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, UK.'}, {'ForeName': 'Trish', 'Initials': 'T', 'LastName': 'Singh', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, UK.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Dweck', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, UK.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, UK.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Williams', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, UK.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Adamson', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, UK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, UK.'}]",European heart journal. Quality of care & clinical outcomes,['10.1093/ehjqcco/qcaa006']
409,32154936,"Upper gastrointestinal mucosal injury associated with ticagrelor plus aspirin, ticagrelor alone, or aspirin alone at 1-year after coronary artery bypass grafting.","BACKGROUND AND AIM


The presence and severity of upper gastrointestinal mucosal lesions have not been evaluated using esophagogastroduodenoscopy (EGD) in patients receiving ticagrelor plus aspirin or alone after myocardial revascularization. We assessed upper gastrointestinal mucosal injury and the use of proton pump inhibitors (PPIs) in patients receiving 1 year of antiplatelet therapy after coronary artery bypass grafting (CABG).
METHODS


In this single-center prospective substudy of a randomized trial, 231 patients completing 1-year antiplatelet therapy (ticagrelor 90 mg twice daily plus aspirin 100 mg once daily, ticagrelor 90 mg twice daily, or aspirin 100 mg once daily, in 81, 80, and 70 patients, respectively) after CABG underwent  13  C urea breath testing and EGD. Gastroduodenal lesions were assessed by modified Lanza score, and reflux esophagitis was evaluated according to Los Angeles classification. Additionally, at least one ulcer ≥ 5 mm was separately analyzed.
RESULTS


Among 231 patients, EGD showed 28 (12.1%) with ulcers ≥ 5 mm, which were detected in 13.6% (11/81) of ticagrelor plus aspirin recipients, 8.8% (7/80) of ticagrelor recipients, and 14.3% (10/70) of aspirin recipients, and 24 (10.4%) had reflux esophagitis. Eighty-eight (38.1%) patients had a positive  13  C urea breath testing after 1 year of treatment, and one patient received eradication therapy during follow up. Nineteen (8.2%) patients received a PPI for ≥ 6 months.
CONCLUSIONS


Severe upper gastrointestinal mucosal lesions were more frequently observed in patients treated with ticagrelor plus aspirin and aspirin monotherapy than in patients treated with ticagrelor monotherapy for 1 year post-CABG. Prophylactic use of PPIs might be inadequate.",2020,Severe upper gastrointestinal mucosal lesions were more frequently observed in patients treated with ticagrelor plus aspirin and aspirin monotherapy than in patients treated with ticagrelor monotherapy for 1 year post-CABG.,"['231 patients completing 1-year', 'Nineteen (8.2%) patients received a PPI for ≥', 'at 1-year after coronary artery bypass grafting', 'patients receiving 1\xa0year of antiplatelet therapy after coronary artery bypass grafting (CABG']","['ticagrelor monotherapy', 'antiplatelet therapy (ticagrelor 90\xa0mg twice daily plus aspirin', 'aspirin', 'proton pump inhibitors (PPIs', 'ticagrelor plus aspirin, ticagrelor alone, or aspirin alone', 'aspirin monotherapy', 'ticagrelor plus aspirin', 'ticagrelor 90\xa0mg twice daily, or aspirin']","['Severe upper gastrointestinal mucosal lesions', 'modified Lanza score, and reflux esophagitis', 'reflux esophagitis', 'Gastroduodenal lesions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C3163568', 'cui_str': 'Ticagrelor 90 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0677659', 'cui_str': 'Gastroesophageal reflux disease with esophagitis (disorder)'}, {'cui': 'C0450199', 'cui_str': 'Gastroduodenal (qualifier value)'}]",231.0,0.0682495,Severe upper gastrointestinal mucosal lesions were more frequently observed in patients treated with ticagrelor plus aspirin and aspirin monotherapy than in patients treated with ticagrelor monotherapy for 1 year post-CABG.,"[{'ForeName': 'Chenyue', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Gastroenterology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiovascular Surgery, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Geriatrics, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Gastroenterology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': 'Department of Cardiovascular Surgery, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiovascular Surgery, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'Department of Gastroenterology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiovascular Surgery, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lifen', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Gastroenterology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15030']
410,31634678,An exploratory parallel-group randomised controlled trial of antenatal Guided Self-Help (plus usual care) versus usual care alone for pregnant women with depression: DAWN trial.,"BACKGROUND


Depression is a common antenatal mental disorder associated with significant maternal morbidity and adverse fetal outcomes. However, there is a lack of research on the effectiveness or cost-effectiveness of psychological interventions for antenatal depression.
METHODS


A parallel-group, exploratory randomised controlled trial across five hospitals. The trial compared Guided Self-Help, modified for pregnancy, plus usual care with usual care alone for pregnant women meeting DSM-IV criteria for mild-moderate depression. The trial objectives were to establish recruitment/follow-up rates, compliance and acceptability, and to provide preliminary evidence of intervention efficacy and cost-effectiveness. The primary outcome of depressive symptoms was assessed by blinded researchers using the Edinburgh Postnatal Depression Scale at 14-weeks post-randomisation.
RESULTS


620 women were screened, 114 women were eligible and 53 (46.5%) were randomised. 26 women received Guided Self-Help - 18 (69%) attending ≥4 sessions - and 27 usual care; n = 3 women were lost to follow-up (follow-up rate for primary outcome 92%). Women receiving Guided Self-Help reported fewer depressive symptoms at follow-up than women receiving usual care (adjusted effect size -0.64 (95%CI: -1.30, 0.06) p = 0.07). There were no trial-related adverse events. The cost-effectiveness acceptability curve showed the probability of Guided Self-Help being cost-effective compared with usual care ranged from 10 to 50% with a willingness-to-pay range from £0 to £50,000.
CONCLUSIONS AND LIMITATIONS


Despite intense efforts we did not meet our anticipated recruitment target. However, high levels of acceptability, a lack of adverse events and a trend towards improvements in symptoms of depression post-treatment indicates this intervention is suitable for talking therapy services.",2020,Women receiving Guided Self-Help reported fewer depressive symptoms at follow-up than women receiving usual care (adjusted effect size -0.64,"['pregnant women meeting DSM-IV criteria for mild-moderate depression', 'pregnant women with depression', '620 women were screened, 114 women were eligible and 53 (46.5%) were randomised', '26 women received Guided Self-Help - 18 (69%) attending ≥4 sessions - and 27 usual care; n\xa0=\xa03 women']","['Guided Self-Help, modified for pregnancy, plus usual care with usual care alone', 'antenatal Guided Self-Help (plus usual care) versus usual care alone', '95%CI']","['depressive symptoms', 'Edinburgh Postnatal Depression Scale', 'cost-effectiveness acceptability']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression (disorder)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",620.0,0.178294,Women receiving Guided Self-Help reported fewer depressive symptoms at follow-up than women receiving usual care (adjusted effect size -0.64,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Trevillion', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience at King's College London, United Kingdom. Electronic address: kylee.trevillion@kcl.ac.uk.""}, {'ForeName': 'E G', 'Initials': 'EG', 'LastName': 'Ryan', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience at King's College London, United Kingdom; Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry CV4 7AL, United Kingdom.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pickles', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience at King's College London, United Kingdom.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Heslin', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience at King's College London, United Kingdom.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Byford', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience at King's College London, United Kingdom.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nath', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience at King's College London, United Kingdom.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bick', 'Affiliation': ""Departmentof Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, United Kingdom.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Milgrom', 'Affiliation': 'University of Melbourne and Parent-Infant Research Institute, Melbourne, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mycroft', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience at King's College London, United Kingdom.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Domoney', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience at King's College London, United Kingdom.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pariante', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience at King's College London, United Kingdom.""}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Hunter', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience at King's College London, United Kingdom.""}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Howard', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience at King's College London, United Kingdom.""}]",Journal of affective disorders,['10.1016/j.jad.2019.10.013']
411,31452942,A randomized clinical study to evaluate the effect of denture adhesive application technique on food particle accumulation under dentures.,"Food ingress under dentures is a common problem that may be reduced by denture adhesive use. The objective of this study was to explore the effect of the mode of application of a denture adhesive on reducing accumulation of food particles under dentures. This was a single-centre, controlled, single-blind, randomized, three-treatment, three-period, crossover study in participants with complete, removable well-fitting, well-made upper/lower dentures. Treatments were: 1) experimental denture adhesive application (test adhesive) applied with a precision applicator as continuous strips; 2) marketed denture adhesive (positive control) applied using a flat ribbon nozzle as dabs; 3) no adhesive. Food-occlusion testing was performed by assessing peanut particle migration under dentures with denture retention/stability evaluated using the Kapur Index (Olshan modification). Differences were assessed using an ANOVA model. Adhesive oozing and perceptions of the adhesives were assessed by questionnaire. All 83 randomized participants completed the study. There were no significant differences between positive control or test adhesives versus no adhesive, or between test adhesive and positive control, for mass of peanut particles recovered from dentures. Both adhesives had significantly higher retention and stability scores compared with no adhesive (all  P  < .01). Participants reported significantly higher scores for denture comfort, confidence, satisfaction and movement with both adhesives versus no adhesive (all  P  < .01). No differences in adhesive ooze were reported between adhesives. No adverse events were reported. In conclusion, there was no difference in performance, as measured by peanut particle mass recovered from upper/lower dentures, for the test adhesive, positive control and no adhesive.",2019,Both adhesives had significantly higher retention and stability scores compared with no adhesive (all  P  ,"['participants with complete, removable well-fitting, well-made upper/lower dentures', 'food particle accumulation under dentures']","['denture adhesive application (test adhesive) applied with a precision applicator as continuous strips; 2) marketed denture adhesive (positive control) applied using a flat ribbon nozzle as dabs; 3) no adhesive', 'denture adhesive application technique']","['adverse events', 'adhesive ooze', 'retention and stability scores', 'denture comfort, confidence, satisfaction and movement with both adhesives versus no adhesive']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C0311119', 'cui_str': 'Food particle'}]","[{'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1879722', 'cui_str': 'Applicator'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1321564', 'cui_str': 'Strip'}, {'cui': 'C1318228', 'cui_str': 'Market (environment)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205324', 'cui_str': 'Flat (qualifier value)'}, {'cui': 'C0086162', 'cui_str': 'Dab (substance)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",83.0,0.101902,Both adhesives had significantly higher retention and stability scores compared with no adhesive (all  P  ,"[{'ForeName': 'Mounir', 'Initials': 'M', 'LastName': 'Atassi', 'Affiliation': 'GSK Consumer Healthcare Weybridge, Surrey UK.'}, {'ForeName': 'Kimberly R', 'Initials': 'KR', 'LastName': 'Milleman', 'Affiliation': 'Salus Research Inc. Fort Wayne Indiana USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Burnett', 'Affiliation': 'GSK Consumer Healthcare Weybridge, Surrey UK.'}, {'ForeName': 'Susmita', 'Initials': 'S', 'LastName': 'Sanyal', 'Affiliation': 'Syneos Health Hyderabad India.'}, {'ForeName': 'Jeffery L', 'Initials': 'JL', 'LastName': 'Milleman', 'Affiliation': 'Salus Research Inc. Fort Wayne Indiana USA.'}]",Clinical and experimental dental research,['10.1002/cre2.168']
412,31751317,Microbial functional change is linked with clinical outcomes after capsular fecal transplant in cirrhosis.,"BACKGROUNDHepatic encephalopathy (HE) is associated with poor outcomes. A prior randomized, pilot trial demonstrated safety after oral capsular fecal microbial transplant (FMT) in HE, with favorable changes in microbial composition and cognition. However, microbial functional changes are unclear. The aim of this study was to determine the effect of FMT on the gut-brain axis compared with placebo, using microbial function based on bile acids (BAs), inflammation (serum IL-6, LPS-binding protein [LBP]), and their association with EncephalApp.METHODSTwenty cirrhotic patients were randomized 1:1 into groups that received 1-time FMT capsules from a donor enriched in Lachnospiraceae and Ruminococcaceae or placebo capsules, with 5-month follow-up for safety outcomes. Stool microbiota and BA; serum IL-6, BA, and LBP; and EncephalApp were analyzed at baseline and 4 weeks after FMT/placebo. Correlation networks among microbiota, BAs, EncephalApp, IL-6, and LBP were performed before/after FMT.RESULTSFMT-assigned participants had 1 HE recurrence and 2 unrelated infections. Six placebo-assigned participants developed negative outcomes. FMT, but not placebo, was associated with reduced serum IL-6 and LBP and improved EncephalApp. FMT-assigned participants demonstrated higher deconjugation and secondary BA formation in feces and serum compared with baseline. No change was seen in placebo. Correlation networks showed greater complexity after FMT compared with baseline. Beneficial taxa, such as Ruminococcaceae, Verrucomicrobiaceae, and Lachnospiraceae, were correlated with cognitive improvement and decrease in inflammation after FMT. Fecal/serum secondary/primary ratios and PiCRUST secondary BA pathways did not increase in participants who developed poor outcomes.CONCLUSIONGut microbial function in cirrhosis is beneficially affected by capsular FMT, with improved inflammation and cognition. Lower secondary BAs in FMT recipients could select for participants who develop negative outcomes.TRIAL REGISTRATIONClinicaltrials.gov NCT03152188.FUNDINGNational Center for Advancing Translational Sciences NIH grant R21TR002024, VA Merit Review grant 2I0CX001076, the United Kingdom National Institute for Health Research Biomedical Facility at Imperial College London, the British Heart Foundation, Wellcome Trust, and King's College London.",2019,"Fecal/serum secondary/primary ratios and PiCRUST secondary BA pathways did not increase in participants who developed poor outcomes.
","['20 cirrhotic patients', 'Capsular Fecal Transplant in Cirrhosis']","['Six placebo', 'placebo', 'receiving one-time FMT capsules from a donor enriched in Lachnospiraceae and Ruminococcaceae, or placebo', 'oral capsular FMT', 'FMT']","['Stool microbiota and BA, serum IL-6, BA and LBP, and EncephalApp', 'HE recurrence', 'Fecal/serum secondary/primary ratios and PiCRUST secondary BA pathways', 'serum IL-6 and LBP and improved EncephalApp', 'Correlation networks between microbiota, BAs, EncephalApp, IL-6 and LBP', 'higher deconjugation and secondary BA formation', 'negative outcomes', 'bile acids (BA), inflammation (serum IL-6, lipopolysaccharide-binding protein,LBP), and EncephalApp', 'microbial composition and cognition']","[{'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205151', 'cui_str': 'Capsular (qualifier value)'}, {'cui': 'C2242628', 'cui_str': 'Fecal Transplantation'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C1210564', 'cui_str': 'Lachnospiraceae'}, {'cui': 'C2584567', 'cui_str': 'Ruminococcaceae'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205151', 'cui_str': 'Capsular (qualifier value)'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0065054', 'cui_str': 'LPS-binding protein'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.277157,"Fecal/serum secondary/primary ratios and PiCRUST secondary BA pathways did not increase in participants who developed poor outcomes.
","[{'ForeName': 'Jasmohan S', 'Initials': 'JS', 'LastName': 'Bajaj', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Salzman', 'Affiliation': 'Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Chathur', 'Initials': 'C', 'LastName': 'Acharya', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Takei', 'Affiliation': 'Junshin Clinic Bile Acid Institute, Meguro-Ku, Tokyo, Japan.'}, {'ForeName': 'Genta', 'Initials': 'G', 'LastName': 'Kakiyama', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fagan', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Melanie B', 'Initials': 'MB', 'LastName': 'White', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Gavis', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Holtz', 'Affiliation': 'Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hayward', 'Affiliation': 'Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nittono', 'Affiliation': 'Junshin Clinic Bile Acid Institute, Meguro-Ku, Tokyo, Japan.'}, {'ForeName': 'Phillip B', 'Initials': 'PB', 'LastName': 'Hylemon', 'Affiliation': 'Department of Microbiology and Immunology, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'I Jane', 'Initials': 'IJ', 'LastName': 'Cox', 'Affiliation': 'Institute for Hepatology London, Foundation for Liver Research, London, United Kingdom.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Institute for Hepatology London, Foundation for Liver Research, London, United Kingdom.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Taylor-Robinson', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Sterling', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Matherly', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Puri', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'R Todd', 'Initials': 'RT', 'LastName': 'Stravitz', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Ajayi', 'Affiliation': 'Institute for Hepatology London, Foundation for Liver Research, London, United Kingdom.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Le Guennec', 'Affiliation': ""Randall Centre for Cell & Molecular Biophysics and Centre for Biomolecular Spectroscopy, King's College London, London, United Kingdom.""}, {'ForeName': 'R Andrew', 'Initials': 'RA', 'LastName': 'Atkinson', 'Affiliation': ""Randall Centre for Cell & Molecular Biophysics and Centre for Biomolecular Spectroscopy, King's College London, London, United Kingdom.""}, {'ForeName': 'Mohammad S', 'Initials': 'MS', 'LastName': 'Siddiqui', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Velimir', 'Initials': 'V', 'LastName': 'Luketic', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Pandak', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Sikaroodi', 'Affiliation': 'Microbiome Analysis Center, George Mason University, Manassas, Virginia, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Gillevet', 'Affiliation': 'Microbiome Analysis Center, George Mason University, Manassas, Virginia, USA.'}]",JCI insight,['10.1172/jci.insight.133410']
413,30475764,Systematic Multi-Domain Alzheimer's Risk Reduction Trial (SMARRT): Study Protocol.,"This article describes the protocol for the Systematic Multi-domain Alzheimer's Risk Reduction Trial (SMARRT), a single-blind randomized pilot trial to test a personalized, pragmatic, multi-domain Alzheimer's disease (AD) risk reduction intervention in a US integrated healthcare delivery system. Study participants will be 200 higher-risk older adults (age 70-89 years with subjective cognitive complaints, low normal performance on cognitive screen, and ≥ two modifiable risk factors targeted by our intervention) who will be recruited from selected primary care clinics of Kaiser Permanente Washington, oversampling people with non-white race or Hispanic ethnicity. Study participants will be randomly assigned to a two-year Alzheimer's risk reduction intervention (SMARRT) or a Health Education (HE) control. Randomization will be stratified by clinic, race/ethnicity (non-Hispanic white versus non-white or Hispanic), and age (70-79, 80-89). Participants randomized to the SMARRT group will work with a behavioral coach and nurse to develop a personalized plan related to their risk factors (poorly controlled hypertension, diabetes with evidence of hyper or hypoglycemia, depressive symptoms, poor sleep quality, contraindicated medications, physical inactivity, low cognitive stimulation, social isolation, poor diet, smoking). Participants in the HE control group will be mailed general health education information about these risk factors for AD. The primary outcome is two-year cognitive change on a cognitive test composite score. Secondary outcomes include: 1) improvement in targeted risk factors, 2) individual cognitive domain composite scores, 3) physical performance, 4) functional ability, 5) quality of life, and 6) incidence of mild cognitive impairment, AD, and dementia. Primary and secondary outcomes will be assessed in both groups at baseline and 6, 12, 18, and 24 months.",2019,Study participants will be randomly assigned to a two-year Alzheimer's risk reduction intervention (SMARRT) or a Health Education (HE) control.,"['race/ethnicity (non-Hispanic white versus non-white or Hispanic), and age (70-79, 80-89', '200 higher-risk older adults (age 70-89 years with subjective cognitive complaints, low normal performance on cognitive screen, and ≥ two modifiable risk factors targeted by our intervention) who will be recruited from selected primary care clinics of Kaiser Permanente Washington, oversampling people with non-white race or Hispanic ethnicity']","[""Alzheimer's risk reduction intervention (SMARRT) or a Health Education (HE) control"", 'SMARRT', ""Systematic Multi-Domain Alzheimer's Risk Reduction Trial (SMARRT"", 'behavioral coach and nurse to develop a personalized plan related to their risk factors (poorly controlled hypertension, diabetes with evidence of hyper or hypoglycemia, depressive symptoms, poor sleep quality, contraindicated medications, physical inactivity, low cognitive stimulation, social isolation, poor diet, smoking']","[' 1) improvement in targeted risk factors, 2) individual cognitive domain composite scores, 3) physical performance, 4) functional ability, 5) quality of life, and 6) incidence of mild cognitive impairment, AD, and dementia', 'two-year cognitive change on a cognitive test composite score']","[{'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0018701'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation (regime/therapy)'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2607857'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0034380'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",200.0,0.0662595,Study participants will be randomly assigned to a two-year Alzheimer's risk reduction intervention (SMARRT) or a Health Education (HE) control.,"[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Yaffe', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Deborah E', 'Initials': 'DE', 'LastName': 'Barnes', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Dori', 'Initials': 'D', 'LastName': 'Rosenberg', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Dublin', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Allison R', 'Initials': 'AR', 'LastName': 'Kaup', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Evette J', 'Initials': 'EJ', 'LastName': 'Ludman', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Carrie B', 'Initials': 'CB', 'LastName': 'Peltz', 'Affiliation': 'San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA.'}, {'ForeName': 'Anne D', 'Initials': 'AD', 'LastName': 'Renz', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Kristin J', 'Initials': 'KJ', 'LastName': 'Adams', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Larson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-180634']
414,31220200,"Long-term effect of community-based continence promotion on urinary symptoms, falls and healthy active life expectancy among older women: cluster randomised trial.","BACKGROUND


The long-term effectiveness of group continence promotion delivered via community organisations on female urinary incontinence, falls and healthy life expectancy remains unknown.
METHODS


A pragmatic cluster randomised trial was conducted among 909 women aged 65-98 years with urinary incontinence, recruited from 377 community organisations in the UK, Canada and France. A total of 184 organisations were randomised to an in-person 60-min incontinence self-management workshop (461 participants), and 193 to a control healthy ageing workshop (448 participants). The primary outcome was self-reported incontinence improvement at 1-year. Falls and gains in health utility were secondary outcomes.
RESULTS


A total 751 women, mean age 78.0, age range 65-98 completed the trial (83%). At 1-year, 15% of the intervention group versus 6.9% of controls reported significant improvements in urinary symptoms, (difference 8.1%, 95% confidence intervals (CI) 4.0-12.1%, intracluster correlation 0.04, number-needed-to-treat 13) and 35% versus 19% reported any improvement (risk difference 16.0%, 95% CI 10.4-21.5, number-needed-to-treat 6). The proportion of fallers decreased from 42% to 36% in the intervention group (-8.0%, 95% CI -14.8 - -1.0) and from 44% to 34% in the control group (-10.3%, 95% CI -17.4 - -3.6), no difference between groups. Both intervention and control groups experienced a gain in health utility (0.022 points (95% CI 0.005-0.04) versus 0.035 (95% CI 0.017-0.052), respectively), with no significant difference between groups.
CONCLUSION


Community-based group continence promotion achieves long-term benefits on older women's urinary symptoms, without improvement in falls or healthy life expectancy compared with participation in a healthy ageing workshop.",2019,"Both intervention and control groups experienced a gain in health utility (0.022 points (95% CI 0.005-0.04) versus 0.035 (95% CI 0.017-0.052), respectively), with no significant difference between groups.
","['A total 751 women, mean age 78.0, age range 65-98 completed the trial (83', '909 women aged 65-98 years with urinary incontinence, recruited from 377 community organisations in the UK, Canada and France', ""older women's urinary symptoms"", 'A total of 184 organisations', 'older women', '461 participants), and 193 to a control healthy ageing workshop (448 participants']","['Community-based group continence promotion', 'group continence promotion delivered via community organisations', 'community-based continence promotion', 'person 60-min incontinence self-management workshop']","['urinary symptoms, falls and healthy active life expectancy', 'proportion of fallers', 'Falls and gains in health utility', 'self-reported incontinence improvement at 1-year', 'gain in health utility', 'urinary symptoms']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",909.0,0.343054,"Both intervention and control groups experienced a gain in health utility (0.022 points (95% CI 0.005-0.04) versus 0.035 (95% CI 0.017-0.052), respectively), with no significant difference between groups.
","[{'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Tannenbaum', 'Affiliation': 'Department of Geriatrics, Faculty of Medicine, Université de Montréal, Quebec, Canada.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Fritel', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculté de Médecine et Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Halme', 'Affiliation': 'Department of Geriatrics, Internal Medicine Resident, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Clinical Sciences, Brunel Institute for Ageing Studies, Brunel University, Uxbridge, UK.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Jutai', 'Affiliation': 'Department of Health Sciences, Interdisciplinary School of Health Sciences, University of Ottawa, Ottawa, Ontario Canada.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wagg', 'Affiliation': 'Department of Geriatrics, Faculty of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}]",Age and ageing,['10.1093/ageing/afz038']
415,30687508,Rationale and design of the Coronary Microvascular Angina Cardiac Magnetic Resonance Imaging (CorCMR) diagnostic study: the CorMicA CMR sub-study.,"Introduction


Angina with no obstructive coronary artery disease (ANOCA) is a common syndrome with unmet clinical needs. Microvascular and vasospastic angina are relevant but may not be diagnosed without measuring coronary vascular function. The relationship between cardiovascular magnetic resonance (CMR)-derived myocardial blood flow (MBF) and reference invasive coronary function tests is uncertain. We hypothesise that multiparametric CMR assessment will be clinically useful in the ANOCA diagnostic pathway.
Methods/analysis


The Stratified Medical Therapy Using Invasive Coronary Function Testing In Angina (CorMicA) trial is a prospective, blinded, randomised, sham-controlled study comparing two management approaches in patients with ANOCA. We aim to recruit consecutive patients with stable angina undergoing elective invasive coronary angiography. Eligible patients with ANOCA (n=150) will be randomised to invasive coronary artery function-guided diagnosis and treatment (intervention group) or not (control group). Based on these test results, patients will be stratified into disease endotypes: microvascular angina, vasospastic angina, mixed microvascular/vasospastic angina, obstructive epicardial coronary artery disease and non-cardiac chest pain. After randomisation in CorMicA, subjects will be invited to participate in the Coronary Microvascular Angina Cardiac Magnetic Resonance Imaging (CorCMR) substudy. Patients will undergo multiparametric CMR and have assessments of MBF (using a novel pixel-wise fully quantitative method), left ventricular function and mass, and tissue characterisation (T1 mapping and late gadolinium enhancement imaging). Abnormalities of myocardial perfusion and associations between MBF and invasive coronary artery function tests will be assessed. The CorCMR substudy represents the largest cohort of ANOCA patients with paired multiparametric CMR and comprehensive invasive coronary vascular function tests.
Ethics/dissemination


The CorMicA trial and CorCMR substudy have UK REC approval (ref.16/WS/0192).
Trial registration number


NCT03193294.",2018,"In Angina (CorMicA) trial is a prospective, blinded, randomised, sham-controlled study comparing two management approaches in patients with ANOCA.","['Introduction\n\n\nAngina with no obstructive coronary artery disease (ANOCA', 'consecutive patients with stable angina undergoing elective invasive coronary angiography', 'patients will be stratified into disease endotypes: microvascular angina, vasospastic angina, mixed microvascular/vasospastic angina, obstructive epicardial coronary artery disease and non-cardiac chest pain', 'Eligible patients with ANOCA (n=150', 'patients with ANOCA']","['invasive coronary artery function-guided diagnosis and treatment (intervention group) or not (control group', 'Coronary Microvascular Angina Cardiac Magnetic Resonance Imaging (CorCMR']",['cardiovascular magnetic resonance (CMR)-derived myocardial blood flow (MBF'],"[{'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0340288', 'cui_str': 'Angina Pectoris, Stable'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0206064', 'cui_str': 'Microvascular Angina'}, {'cui': 'C0002963', 'cui_str': 'Prinzmetal Angina'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}, {'cui': 'C0476281', 'cui_str': 'Non-cardiac chest pain (finding)'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0206064', 'cui_str': 'Microvascular Angina'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]",150.0,0.101319,"In Angina (CorMicA) trial is a prospective, blinded, randomised, sham-controlled study comparing two management approaches in patients with ANOCA.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Corcoran', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ford', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Li-Yueh', 'Initials': 'LY', 'LastName': 'Hsu', 'Affiliation': 'Advanced Cardiovascular Imaging Laboratory, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Amedeo', 'Initials': 'A', 'LastName': 'Chiribiri', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, Department of Cardiovascular Imaging, King's College London, London, UK.""}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Orchard', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Mangion', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McEntegart', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rocchiccioli', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Watkins', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Good', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK.'}, {'ForeName': 'Katriona', 'Initials': 'K', 'LastName': 'Brooksbank', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Sandosh', 'Initials': 'S', 'LastName': 'Padmanabhan', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Oldroyd', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK.'}, {'ForeName': 'Rhian M', 'Initials': 'RM', 'LastName': 'Touyz', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Arai', 'Affiliation': 'Advanced Cardiovascular Imaging Laboratory, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}]",Open heart,['10.1136/openhrt-2018-000924']
416,31320353,Evaluation of a personalised adherence intervention to improve photoprotection in adults with Xeroderma Pigmentosum (XP): protocol for the trial of XPAND.,"INTRODUCTION


Poor adherence to photoprotection for people with xeroderma pigmentosum (XP) can be life-threatening. A randomised controlled trial (RCT) is being conducted to test the efficacy of a personalised adherence intervention (XPAND) to reduce the level of ultraviolet radiation (UVR) reaching the face, by improving photoprotection activities in adults with XP.
METHODS AND ANALYSIS


A two-armed parallel groups RCT, where we randomised 24 patients with suboptimal adherence to either an intervention group who received XPAND in 2018 or a delayed intervention group who will receive XPAND in 2019. XPAND involves seven sessions, one-to-one with a facilitator, using behaviour change techniques and specially designed materials to target barriers to photoprotection. Following baseline assessment in April 2018 (t0) and intervention, the primary outcome will be measured across 21 consecutive days in June and July 2018 (t1). The primary outcome is the average daily UVR dose to the face (D-to-F), calculated by combining objective UVR exposure at the wrist (measured by a dosimeter) with face photoprotection activities recorded on a daily UVR protection diary. Secondary outcomes include average daily UVR D-to-F across 21 days in August (t2); psychosocial process variables measured by daily questions (t0, t1, t2) and self-report questionnaires (t0, t1, t2, December 2018 (t3)). Intervention cost-utility is assessed by service use and personal cost questionnaires (t0, t3). The delayed intervention control arm participants will complete three further assessments in April 2019 (t4) and June-July 2019 (t5), and December 2019 (t6) with dosimetry and UVR protection diary completed for 21 days at t4 and t5. A process evaluation will be conducted using mixed methods.
ETHICS AND DISSEMINATION


Ethical approval has been received from West London & GTAC REC 17/LO/2110. Results will be disseminated in peer-reviewed journals and at conferences. This study tests a novel intervention, which, if successful, will be integrated into routine care.
TRIAL REGISTRATION NUMBER


NCT03445052; Pre-results.",2019,"A randomised controlled trial (RCT) is being conducted to test the efficacy of a personalised adherence intervention (XPAND) to reduce the level of ultraviolet radiation (UVR) reaching the face, by improving photoprotection activities in adults with XP.
","['adults with XP', 'people with xeroderma pigmentosum (XP', 'adults with Xeroderma Pigmentosum (XP', '24 patients with suboptimal adherence to either an intervention group who received']","['XPAND in 2018 or a delayed intervention group who will receive XPAND', 'personalised adherence intervention (XPAND', 'personalised adherence intervention']","['average daily UVR dose to the face (D-to-F), calculated by combining objective UVR exposure at the wrist (measured by a dosimeter) with face photoprotection activities recorded on a daily UVR protection diary', 'average daily UVR D-to-F across 21 days in August (t2); psychosocial process variables measured by daily questions (t0, t1, t2) and self-report questionnaires']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043346', 'cui_str': 'Kaposi Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4082307', 'cui_str': 'Dosimeters'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",21.0,0.0897841,"A randomised controlled trial (RCT) is being conducted to test the efficacy of a personalised adherence intervention (XPAND) to reduce the level of ultraviolet radiation (UVR) reaching the face, by improving photoprotection activities in adults with XP.
","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Walburn', 'Affiliation': ""School of Cancer and Pharmaceutical Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Norton', 'Affiliation': ""Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sarkany', 'Affiliation': ""National Xeroderma Pigmentosum Service, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Kirby', 'Initials': 'K', 'LastName': 'Sainsbury', 'Affiliation': 'Faculty of Medical Sciences, Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Araújo-Soares', 'Affiliation': 'Faculty of Medical Sciences, Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Myfanwy', 'Initials': 'M', 'LastName': 'Morgan', 'Affiliation': ""School of Cancer and Pharmaceutical Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Canfield', 'Affiliation': ""Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Foster', 'Affiliation': ""National Xeroderma Pigmentosum Service, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Heydenreich', 'Affiliation': 'Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Health Service & Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Mander', 'Affiliation': 'MRC Biostatistics Unit, School of Clinical Medicine, Cambridge Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Falko F', 'Initials': 'FF', 'LastName': 'Sniehotta', 'Affiliation': 'Faculty of Medical Sciences, Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Hans Christian', 'Initials': 'HC', 'LastName': 'Wulf', 'Affiliation': 'Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Weinman', 'Affiliation': ""School of Cancer and Pharmaceutical Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}]",BMJ open,['10.1136/bmjopen-2018-028577']
417,32152513,Effects of substituting eggs for high-carbohydrate breakfast foods on the cardiometabolic risk-factor profile in adults at risk for type 2 diabetes mellitus.,"OBJECTIVES


To assess effects of egg-based versus non-egg, higher-carbohydrate (CHO) breakfast meals on cardiometabolic health markers in overweight or obese adults with prediabetes and/or metabolic syndrome.
METHODS


This randomized, crossover study included two 4-week dietary interventions, separated by a ≥4-week washout. Subjects incorporated into their habitual diets breakfast meals containing either 2 eggs/day for 6 days/week (Egg condition), or energy-matched, non-egg, higher-CHO-based foods (Non-Egg condition). Dietary intakes, insulin sensitivity, and other CHO metabolism indices, lipid biomarkers, high-sensitivity C-reactive protein, and blood pressures were measured.
RESULTS


Thirty men and women with mean age 54.1 ± 1.9 years and body mass index 31.9 ± 0.7 kg/m 2  provided data. Neither diet condition significantly altered insulin sensitivity indices, but the homeostasis model assessment for insulin resistance was significantly (p = 0.028) higher after the Non-Egg vs. the Egg condition. Low-density lipoprotein cholesterol (LDL-C) was decreased from baseline (119 mg/dL) by 2.9 and 6.0% with Egg and Non-Egg breakfasts, respectively (p = 0.023). Systolic blood pressure was reduced from baseline (127 mm Hg) by 2.7 and 0.0% with Egg and Non-Egg, respectively (p = 0.018). Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
CONCLUSION


Compared with the baseline diet, consumption of 12 eggs/week for 4 weeks at breakfast was associated with less reduction in LDL-C, and more lowering of systolic blood pressure, than observed with non-egg-based, energy-matched, control foods higher in CHO.",2020,"Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
","['overweight or obese adults with prediabetes and/or metabolic syndrome', 'Thirty men and women with mean age 54.1\u2009±\u20091.9\u2009years and body mass index 31.9\u2009±\u20090.7\u2009kg/m 2  provided data', 'adults at risk for type 2 diabetes mellitus']","['egg-based versus non-egg, higher-carbohydrate (CHO) breakfast meals']","['lowering of systolic blood pressure', 'Systolic blood pressure', 'Low-density lipoprotein cholesterol (LDL-C', 'Dietary intakes, insulin sensitivity, and other CHO metabolism indices, lipid biomarkers, high-sensitivity C-reactive protein, and blood pressures', 'weight change', 'cardiometabolic risk-factor profile', 'insulin sensitivity indices', 'homeostasis model assessment for insulin resistance', 'cardiometabolic health markers']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0693838,"Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA. kmaki@mbclinicalresearch.com.'}, {'ForeName': 'Orsolya M', 'Initials': 'OM', 'LastName': 'Palacios', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}, {'ForeName': 'Melvyn W', 'Initials': 'MW', 'LastName': 'Kramer', 'Affiliation': 'MB Clinical Research, Boca Raton, FL, USA.'}, {'ForeName': 'Rupal', 'Initials': 'R', 'LastName': 'Trivedi', 'Affiliation': 'Great Lakes Clinical Trials, Chicago, IL, USA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Dicklin', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Wilcox', 'Affiliation': 'MB Clinical Research, Boca Raton, FL, USA.'}, {'ForeName': 'Cathleen E', 'Initials': 'CE', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}]",European journal of clinical nutrition,['10.1038/s41430-020-0599-2']
418,32146123,Prospective Randomized Trial Comparing the Safety and Clarity of Water Versus Saline Irrigant in Ureteroscopy.,"BACKGROUND


Water irrigant is discouraged in ureteroscopy due to risks demonstrated in more invasive endoscopic procedures. However, water is not well studied in ureteroscopy and may provide better visualization than standard saline.
OBJECTIVE


To determine whether water irrigant increases the risk of hyponatremia compared with saline and provides better visualization in ureteroscopy.
DESIGN, SETTING, AND PARTICIPANTS


A randomized, prospective, double-blinded trial was conducted. In 2017, eligible adult ureteroscopy patients at a university hospital were recruited for the study.
INTERVENTION


Participants randomized to water or saline irrigant in ureteroscopy.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Serum sodium and osmolality, body temperature, subjective surgeon visualization, and objective turbidity clarity were analyzed. Chi-square or Fisher's exact tests for categorical variables and analysis of variance test for continuous variables were performed.
RESULTS AND LIMITATIONS


A total of 121 individuals (mean age 57 ± 15 yr) underwent ureteroscopy (mean time 35 ± 18 min) with a mean irrigation volume of 839 ± 608 ml. For the 101 (83%) patients who had nephrolithiasis, the mean number of stones was 2 ± 1 and the mean stone burden was 13 ± 7 mm. There were no significant differences in demographic, clinical, and intraoperative variables between water and saline groups, except for a higher body mass index in the saline group (p = 0.01). There was no significant difference between groups in the incidence of hyponatremia, hypo-osmolality, or hypothermia. The median surgeon visualization score was significantly higher using water (p < 0.01). The mean turbidity was significantly lower with water (p = 0.02). Limitations were not objectively assessing hemolysis or fluid absorption.
CONCLUSIONS


Water irrigant does not increase the incidence of hyponatremia in uncomplicated ureteroscopy and provides clearer visualization than saline.
PATIENT SUMMARY


We compared safety and clarity of water and saline irrigation, which aid surgeon visualization, in ureteroscopy, which can treat kidney stones. We found that water irrigant does not reduce blood sodium levels significantly compared with saline in ureteroscopy and provides better visualization.",2020,"There was no significant difference between groups in the incidence of hyponatremia, hypo-osmolality, or hypothermia.","['121 individuals (mean age 57 ± 15 yr) underwent ureteroscopy (mean time 35 ± 18 min) with a mean irrigation volume of 839 ± 608 ml', 'In 2017, eligible adult ureteroscopy patients at a university hospital were recruited for the study']","['water or saline irrigant in ureteroscopy', 'water and saline irrigation', 'Water Versus Saline Irrigant']","['mean turbidity', 'incidence of hyponatremia', 'blood sodium levels', 'median surgeon visualization score', 'risk of hyponatremia', 'Serum sodium and osmolality, body temperature, subjective surgeon visualization, and objective turbidity clarity', 'incidence of hyponatremia, hypo-osmolality, or hypothermia', 'body mass index', 'demographic, clinical, and intraoperative variables']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4319582', 'cui_str': 'Turbidity'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0729817', 'cui_str': 'Blood sodium measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum (procedure)'}, {'cui': 'C4301987', 'cui_str': 'Osmolality (property)'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property) (qualifier value)'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",,0.331573,"There was no significant difference between groups in the incidence of hyponatremia, hypo-osmolality, or hypothermia.","[{'ForeName': 'Farha', 'Initials': 'F', 'LastName': 'Pirani', 'Affiliation': 'Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Salima S', 'Initials': 'SS', 'LastName': 'Makhani', 'Affiliation': 'School of Medicine, Mercer University, Macon, GA, USA.'}, {'ForeName': 'Frances Y', 'Initials': 'FY', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Aaron H', 'Initials': 'AH', 'LastName': 'Lay', 'Affiliation': 'Department of Urology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Cara B', 'Initials': 'CB', 'LastName': 'Cimmino', 'Affiliation': 'Department of Urology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Hartsell', 'Affiliation': 'Department of Urology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Spence', 'Affiliation': 'Department of Urology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Viraj A', 'Initials': 'VA', 'LastName': 'Master', 'Affiliation': 'Department of Urology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ogan', 'Affiliation': 'Department of Urology, Emory University School of Medicine, Atlanta, GA, USA. Electronic address: kogan@emory.edu.'}]",European urology focus,['10.1016/j.euf.2020.02.009']
419,31678307,A Prospective Randomized Comparative Study of Three Guided Bronchoscopic Approaches for Investigating Pulmonary Nodules: The PRECISION-1 Study.,"BACKGROUND


The capability of bronchoscopy in the diagnosis of peripheral pulmonary nodules (PPNs) remains limited. Despite decades of effort, evidence suggests that the diagnostic accuracy for electromagnetic navigational bronchoscopy (EMN) and radial endobronchial ultrasound (EBUS) approach only 50%. New developments in robotic bronchoscopy (RB) may offer improvements in the assessment of PPNs.
METHODS


A prospective single-blinded randomized controlled comparative study to assess success in localization and puncture of PPNs, using an ultrathin bronchoscope with radial EBUS (UTB-rEBUS) vs EMN vs RB in a human cadaver model of PPNs < 2 cm, was performed. The primary end point was the ability to successfully localize and puncture the target nodule, verified by cone-beam CT comparing RB and EMN. Secondary end points included needle to target position ""miss"" distance, and UTB-rEBUS comparisons.
RESULTS


Sixty procedures were performed to target 20 PPNs over the study period. Implanted PPNs were distributed across all lobes, with 80% located within the lung periphery. The target PPN mean diameter was 16.5 ± 1.5 mm, with 50% noted to have a CT bronchus sign. The rate of successful PPN localization and puncture was superior when using RB, compared with EMN (80% vs 45%; P = .02). Among unsuccessful needle passes, the median needle to target ""miss"" distance was significantly different when comparing UTB-rEBUS, EMN, and RB (P = .0014).
CONCLUSIONS


In a cadaver model, use of RB significantly increased the ability to localize and successfully puncture small PPNs when compared with existing technologies. This study demonstrates the potential of RB to precisely reach, localize, and puncture small nodules in the periphery of the lung.",2020,"In a cadaver model, utilization of RB significantly increased the ability to localize and successfully puncture small PPN when compared with existing technologies.",['and Methods'],"['robotic bronchoscopy (RB', 'Guided Bronchoscopic Approaches', 'PPN utilizing an ultrathin bronchoscope with radial EBUS (UTB-rEBUS) vs EMN vs RB']","['needle to target position, ""miss"" distance and UTB-rEBUS comparisons', 'median needle to target ""miss"" distance', 'rate of successful PPN localization and puncture', 'ability to successfully localize and puncture the target nodule verified using cone-beam CT comparing RB and EMN']","[{'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0179432', 'cui_str': 'Bronchoscopes'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}]","[{'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0475264', 'cui_str': 'Localization - action (qualifier value)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C1956110', 'cui_str': 'Cone-Beam Computerized Tomography'}]",,0.0907955,"In a cadaver model, utilization of RB significantly increased the ability to localize and successfully puncture small PPN when compared with existing technologies.","[{'ForeName': 'Lonny', 'Initials': 'L', 'LastName': 'Yarmus', 'Affiliation': 'Division of Pulmonary and Critical Care, Johns Hopkins University School of Medicine, Baltimore, MD. Electronic address: lyarmus@jhmi.edu.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Akulian', 'Affiliation': 'Division of Pulmonary and Critical Care, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Momen', 'Initials': 'M', 'LastName': 'Wahidi', 'Affiliation': 'Division of Pulmonary and Critical Care, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Division of Pulmonary and Critical Care, Washington University of St. Louis School of Medicine, St. Louis, MO.'}, {'ForeName': 'Jennifer P', 'Initials': 'JP', 'LastName': 'Steltz', 'Affiliation': 'Division of Pulmonary and Critical Care, University of Pennsylvania School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Sam L', 'Initials': 'SL', 'LastName': 'Solomon', 'Affiliation': 'Division of Pulmonary and Critical Care, University of Pennsylvania School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Division of Pulmonary and Critical Care, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Maldonado', 'Affiliation': 'Division of Pulmonary and Critical Care, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Cardenas-Garcia', 'Affiliation': 'Division of Pulmonary and Critical Care, University of Michigan School of Medicine, Ann Arbor, MI.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Molena', 'Affiliation': 'Division of Thoracic Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Vachani', 'Affiliation': 'Division of Pulmonary and Critical Care, University of Pennsylvania School of Medicine, Philadelphia, PA; Division of Pulmonary and Critical Care, University of Pennsylvania School of Medicine, and the Corporal Michael J. Crescenz VA Medical Center Philadelphia, PA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chest,['10.1016/j.chest.2019.10.016']
420,31686302,The Effectiveness of Two Potential Mass Media Interventions on Stigma: Video-Recorded Social Contact and Audio/Visual Simulations.,"Two approaches that may be particularly well suited for mass media (large scale) stigma interventions are video-recorded social contact and simulations, but research is rather limited. The purpose of this study was to evaluate two potential mass media interventions on different facets of stigma. Participants (N = 244) completed stigma measures prior to, immediately following, and 1 week following the random assignment of: (1) video-recorded social contact, (2) an audio/visual simulation, or (3) no intervention. The video-recorded social contact led to decreases on preference for social distance and negative emotions across 1 week, but only a temporary decrease on perceptions of dangerousness. In contrast, no significant changes in stigma were noted following the simulation. In sum, video-recorded social contact appears promising and offers many advantages for mass media implementation including low cost, minimal resources, and ease of dissemination. In contrast, further evaluation of audio/visual simulations is warranted before implementation.",2020,"The video-recorded social contact led to decreases on preference for social distance and negative emotions across 1 week, but only a temporary decrease on perceptions of dangerousness.",[],"['Two Potential Mass Media Interventions', 'video-recorded social contact, (2) an audio/visual simulation, or (3) no intervention']","['social distance and negative emotions', 'Stigma: Video-Recorded Social Contact and Audio/Visual Simulations', 'stigma']",[],"[{'cui': 'C0024869', 'cui_str': 'Mass Media'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0237101', 'cui_str': 'Social interaction finding'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]","[{'cui': 'C0037412', 'cui_str': 'Social Distance'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0237101', 'cui_str': 'Social interaction finding'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]",,0.0178858,"The video-recorded social contact led to decreases on preference for social distance and negative emotions across 1 week, but only a temporary decrease on perceptions of dangerousness.","[{'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Department of Psychology, University of Northern Iowa, Bartlett Hall 1078, Cedar Falls, IA, 50614-0505, USA. seth.brown@uni.edu.'}]",Community mental health journal,['10.1007/s10597-019-00503-8']
421,30863852,Healthcare Costs and Life-years Gained From Treatments Within the Advancing Cryptococcal Meningitis Treatment for Africa (ACTA) Trial on Cryptococcal Meningitis: A Comparison of Antifungal Induction Strategies in Sub-Saharan Africa.,"BACKGROUND


Mortality from cryptoccocal meningitis remains high. The ACTA trial demonstrated that, compared with 2 weeks of amphotericin B (AmB) plus flucystosine (5FC), 1 week of AmB and 5FC was associated with lower mortality and 2 weeks of oral flucanozole (FLU) plus 5FC was non-inferior. Here, we assess the cost-effectiveness of these different treatment courses.
METHODS


Participants were randomized in a ratio of 2:1:1:1:1 to 2 weeks of oral 5FC and FLU, 1 week of AmB and FLU, 1 week of AmB and 5FC, 2 weeks of AmB and FLU, or 2 weeks of AmB and 5FC in Malawi, Zambia, Cameroon, and Tanzania. Data on individual resource use and health outcomes were collected. Cost-effectiveness was measured as incremental costs per life-year saved, and non-parametric bootstrapping was done.
RESULTS


Total costs per patient were US $1442 for 2 weeks of oral FLU and 5FC, $1763 for 1 week of AmB and FLU, $1861 for 1 week of AmB and 5FC, $2125 for 2 weeks of AmB and FLU, and $2285 for 2 weeks of AmB and 5FC. Compared to 2 weeks of AmB and 5FC, 1 week of AmB and 5FC was less costly and more effective and 2 weeks of oral FLU and 5FC was less costly and as effective. The incremental cost-effectiveness ratio for 1 week of AmB and 5FC versus oral FLU and 5FC was US $208 (95% confidence interval $91-1210) per life-year saved.
CLINICAL TRIALS REGISTRATION


ISRCTN45035509.
CONCLUSIONS


Both 1 week of AmB and 5FC and 2 weeks of Oral FLU and 5FC are cost-effective treatments.",2019,"Compared to 2 weeks of AmB and 5FC, 1 week of AmB and 5FC was less costly and more effective and 2 weeks of oral FLU and 5FC was less costly and as effective.","['Africa (ACTA) Trial on Cryptococcal Meningitis', 'Sub-Saharan Africa', 'Participants']","['oral 5FC and FLU, 1 week of AmB and FLU, 1 week of AmB and 5FC, 2 weeks of AmB and FLU, or 2 weeks of AmB and 5FC in Malawi, Zambia, Cameroon, and Tanzania', 'AmB and 5FC versus oral FLU and 5FC', 'oral flucanozole (FLU) plus 5FC', 'amphotericin B (AmB) plus flucystosine (5FC']","['Healthcare Costs and Life-years', 'Cost-effectiveness', 'incremental cost-effectiveness ratio', 'cost-effectiveness']","[{'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0085436', 'cui_str': 'Meningitis, Cryptococcal'}, {'cui': 'C0001738', 'cui_str': 'Subsaharan Africa'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0006802', 'cui_str': 'Republic of Cameron'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002679', 'cui_str': 'Amphotericin B'}]","[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0297931,"Compared to 2 weeks of AmB and 5FC, 1 week of AmB and 5FC was less costly and more effective and 2 weeks of oral FLU and 5FC was less costly and as effective.","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Mwenge', 'Affiliation': 'Zambart, Health Economics Unit, Lusaka Apex Medical University, Zambia.'}, {'ForeName': 'Shabir', 'Initials': 'S', 'LastName': 'Lakhi', 'Affiliation': 'University Teaching Hospital, Lusaka Apex Medical University, Zambia.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Chanda', 'Affiliation': 'Institute for Medical Research and Training, University Teaching Hospital, Lusaka Apex Medical University, Zambia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mwaba', 'Affiliation': 'Department of Internal Medicine and Directorate of Research and Post-Graduate Studies, Lusaka Apex Medical University, Zambia.'}, {'ForeName': 'Síle F', 'Initials': 'SF', 'LastName': 'Molloy', 'Affiliation': ""Centre for Global Health, Institute for Infection and Immunity, St George's University of London, United Kingdom.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Gheorghe', 'Affiliation': 'London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': 'Ulla K', 'Initials': 'UK', 'LastName': 'Griffiths', 'Affiliation': 'London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Heyderman', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Kanyama', 'Affiliation': 'University of North Carolina Project-Malawi, Kamuzu Central Hospital, Lilongwe.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kouanfack', 'Affiliation': 'Hôpital Central Yaoundé/Site Agence Nationale de Recherche sur le Sida Cameroun, Yaoundé Hopitaux de Paris, France.'}, {'ForeName': 'Sayoki', 'Initials': 'S', 'LastName': 'Mfinanga', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Adrienne K', 'Initials': 'AK', 'LastName': 'Chan', 'Affiliation': 'Dignitas International, Zomba Central Hospital, Malawi.'}, {'ForeName': 'Elvis', 'Initials': 'E', 'LastName': 'Temfack', 'Affiliation': 'Douala General Hospital, Cameroon.'}, {'ForeName': 'Sokoine', 'Initials': 'S', 'LastName': 'Kivuyo', 'Affiliation': 'National Institute for Medical Research, Muhimbili Medical Research Centre, Dar Es Salaam, United Republic of Tanzania.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'University of North Carolina Project-Malawi, Kamuzu Central Hospital, Lilongwe.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Lortholary', 'Affiliation': 'Institut Pasteur, Molecular Mycology Unit, Paris, France.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Loyse', 'Affiliation': ""Centre for Global Health, Institute for Infection and Immunity, St George's University of London, United Kingdom.""}, {'ForeName': 'Shabbar', 'Initials': 'S', 'LastName': 'Jaffar', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Harrison', 'Affiliation': ""Centre for Global Health, Institute for Infection and Immunity, St George's University of London, United Kingdom.""}, {'ForeName': 'Louis W', 'Initials': 'LW', 'LastName': 'Niessen', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy971']
422,30723088,Examining intervention mechanisms of action using mediation analysis within a randomised trial of a whole-school health intervention.,"BACKGROUND


Interventions to modify school environments are effective in promoting young people's health across outcomes, but mechanisms are poorly understood. We assessed mediation in a trial of the Learning Together intervention, building on the recent publication of results of effectiveness for reducing bullying and benefits across secondary outcomes and generally good implementation fidelity.
METHODS


Within a cluster-randomised trial involving 40 English schools, we examined student-reported and staff-reported school climate and student-reported involvement with delinquent peers at 24-month and 36-month follow-up, assessing the reliability of measures and whether these mediated health outcomes at a final follow-up.
RESULTS


Response rates and reliability were good for student-reported but not staff-reported measures. The intervention increased student-reported but not staff-reported-positive school climate but, like effects on student health outcomes, these manifested only at a final follow-up. The intervention reduced student-reported contact with delinquent peers at an interim follow-up. Student-reported potential mediators measured at the interim follow-up were associated with most health outcomes at the final follow-up. Adjustment for student-reported school climate and contact with delinquent peers at the interim follow-up did not reduce the associations between trial arm and our health outcomes.
CONCLUSION


Despite being constrained by imperfect measures and by the late manifestation of impacts on student-reported school climate undermining ability to assess mediation, our study for the first time provides tentative evidence that mediation of intervention effects via improved climate and disengagement from delinquent peers is plausible. Our study provides the first evidence from a trial that whole-school interventions may work by modifying school environments and student relationships.
TRIAL REGISTRATION NUMBER


ISRCTN10751359.",2019,"The intervention increased student-reported but not staff-reported-positive school climate but, like effects on student health outcomes, these manifested only at a final follow-up.","['40 English schools, we examined student-reported and staff-reported school climate and student-reported involvement with delinquent peers at 24-month and 36-month follow-up']",[],['student health outcomes'],"[{'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",40.0,0.0535139,"The intervention increased student-reported but not staff-reported-positive school climate but, like effects on student health outcomes, these manifested only at a final follow-up.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'Department of Public Health, Environments and Society, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Opondo', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Warren', 'Affiliation': 'Department of Public Health, Environments and Society, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Diana Ruth', 'Initials': 'DR', 'LastName': 'Elbourne', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Sturgess', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Bevilacqua', 'Affiliation': 'Department of Social Science, UCL Institute of Child Health, London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McGowan', 'Affiliation': 'Department of Social Science, UCL Institute of Child Health, London, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Mathiot', 'Affiliation': 'Department of Social Science, UCL Institute of Child Health, London, UK.'}, {'ForeName': 'Russell M', 'Initials': 'RM', 'LastName': 'Viner', 'Affiliation': 'Department of Social Science, UCL Institute of Child Health, London, UK.'}]",Journal of epidemiology and community health,['10.1136/jech-2018-211443']
423,32152868,Brief Behavioral Therapy for Insomnia in Patients with Irritable Bowel Syndrome: A Pilot Study.,"BACKGROUND


Up to 60% of patients with irritable bowel syndrome (IBS) report fatigue and 50% meet criteria for clinical insomnia. Recent studies have demonstrated a relationship between poor sleep and next-day IBS symptoms. However, no study to-date has evaluated behavioral therapy to treat poor sleep in IBS.
AIMS


The aim of the current pilot study is to test feasibility of behavioral therapy for insomnia among patients with IBS and poor sleep.
METHODS


This randomized controlled pilot study tested the feasibility of administering brief behavioral therapy for insomnia (BBT-I) to patients with IBS who report poor sleep. Participants were randomized to BBT-I or self-monitoring control. Exploratory analyses evaluated group differences after 4 weeks of treatment.
RESULTS


A total of 25 participants were randomized to the study, 13 to BBT-I and 12 to the control group. Three participants dropped out of the treatment group. Satisfaction with treatment was high. At follow-up, there were significant differences between groups in measures of sleep quality and insomnia severity. There were trends toward significance in IBS severity score, with 40% of the BBT-I sample reporting clinically meaningful drop in symptoms compared to 17% of the control group. Similar trends were observed with belly pain and global improvement scores.
CONCLUSIONS


This pilot study demonstrates feasibility/acceptability of a brief behavioral therapy for patients with IBS and poor sleep. Additionally, this study provides preliminary evidence to suggest that treatment of sleep difficulties in patients with IBS may improve IBS symptom outcomes. Future, larger randomized controlled studies are needed.",2020,"At follow-up, there were significant differences between groups in measures of sleep quality and insomnia severity.","['patients with IBS and poor sleep', 'Patients with Irritable Bowel Syndrome', 'patients with IBS', 'patients with IBS who report poor sleep', 'A total of 25 participants were randomized to the study, 13 to BBT-I and 12 to the control group']","['Brief Behavioral Therapy', 'BBT-I or self-monitoring control', 'behavioral therapy']","['sleep quality and insomnia severity', 'belly pain and global improvement scores', 'IBS symptom outcomes', 'IBS severity score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}]",25.0,0.0298679,"At follow-up, there were significant differences between groups in measures of sleep quality and insomnia severity.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ballou', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA. sballou@bidmc.harvard.edu.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Katon', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Rangan', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Cheng', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Nee', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Iturrino', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lembo', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}]",Digestive diseases and sciences,['10.1007/s10620-020-06182-w']
424,31230933,"Incidence, determinants and impact of acute kidney injury in patients with diabetes mellitus and multivessel disease undergoing coronary revascularization: Results from the FREEDOM trial.","BACKGROUND


The incidence and prognostic significance of acute kidney injury (AKI) in patients with diabetes mellitus and multivessel coronary artery disease undergoing coronary revascularization is not well known. The current analysis included patients randomized to PCI vs. CABG as part of the FREEDOM trial. We sought to examine the impact of AKI and its predictors in diabetic patients with multivessel coronary artery disease undergoing PCI vs. CABG.
METHODS


We conducted a pre-specified subgroup analysis of the FREEDOM trial to examine the incidence, correlates and impact of AKI according to revascularization strategy. AKI predictors were identified using multivariable logistic regression and associations between AKI and outcomes were examined using Cox regression. The primary endpoint was the composite occurrence of all-cause death, stroke or myocardial infarction at 5 years of follow-up.
RESULTS


KI occurred more frequently in patients following CABG (15.6%) compared with PCI (9.1%) (p < 0.001). AKI was associated with a higher risk for major cardiovascular events (MACE) at 5 years (34.6% vs. 20.5%, p < 0.001), an effect that remained large and significant irrespective of CABG (HR = 2.18 95% CI 1.44-3.31, p ≤0.001) or PCI (HR = 2.08 95% CI 1.35-3.21, p < 0.0001). There was a non-significant interaction (p-value = 0.89) between the revascularization method and AKI, supporting that AKI is a significant risk factor in both revascularization methods.
CONCLUSIONS


Although risk for AKI was higher in patients undergoing CABG, the impact of AKI on MACE was substantial irrespective of revascularization strategy. Preventive strategies to identify patients at risk for AKI are warranted to mitigate the long-term effects of this complication.",2019,"AKI was associated with a higher risk for major cardiovascular events (MACE) at 5 years (34.6% vs. 20.5%, p < 0.001), an effect that remained large and significant irrespective of CABG (HR = 2.18 95% CI 1.44-3.31, p ≤0.001) or PCI (HR = 2.08 95% CI 1.35-3.21, p < 0.0001).","['patients with diabetes mellitus and multivessel coronary artery disease undergoing coronary revascularization', 'diabetic patients with multivessel coronary artery disease undergoing PCI vs. CABG', 'patients with diabetes mellitus and multivessel disease undergoing coronary revascularization']",['PCI vs. CABG'],"['composite occurrence of all-cause death, stroke or myocardial infarction at 5\u202fyears of follow-up', 'higher risk for major cardiovascular events (MACE', 'KI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}]",,0.272116,"AKI was associated with a higher risk for major cardiovascular events (MACE) at 5 years (34.6% vs. 20.5%, p < 0.001), an effect that remained large and significant irrespective of CABG (HR = 2.18 95% CI 1.44-3.31, p ≤0.001) or PCI (HR = 2.08 95% CI 1.35-3.21, p < 0.0001).","[{'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Arbel', 'Affiliation': 'Department of Cardiology, Tel Aviv Medical Center, Affiliated with the University of Tel Aviv, Tel Aviv, Israel. Electronic address: yarona@tlvmc.gov.il.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, USA; Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, USA; Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain.'}, {'ForeName': 'Taye H', 'Initials': 'TH', 'LastName': 'Hamza', 'Affiliation': 'New England Research Institute (NERI), USA.'}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Siami', 'Affiliation': 'New England Research Institute (NERI), USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Farkouh', 'Affiliation': 'Peter Munk Cardiac Centre, and Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, Canada.'}]",International journal of cardiology,['10.1016/j.ijcard.2019.05.064']
425,31220085,Development of a prognostic risk score to aid antibiotic decision-making for children aged 2-59 months with World Health Organization fast breathing pneumonia in Malawi: An Innovative Treatments in Pneumonia (ITIP) secondary analysis.,"BACKGROUND


Due to increasing antimicrobial resistance in low-resource settings, strategies to rationalize antibiotic treatment of children unlikely to have a bacterial infection are needed. This study's objective was to utilize a database of placebo treated Malawian children with World Health Organization (WHO) fast breathing pneumonia to develop a prognostic risk score that could aid antibiotic decision making.
METHODS


We conducted a secondary analysis of children randomized to the placebo group of the Innovative Treatments in Pneumonia (ITIP) fast breathing randomized, controlled, noninferiority trial. Participants were low-risk HIV-uninfected children 2-59 months old with WHO fast breathing pneumonia in Lilongwe, Malawi. Study endpoints were treatment failure, defined as either disease progression at any time on or before Day 4 of treatment or disease persistence on Day 4, or relapse, considered as the recurrence of pneumonia or severe disease among previously cured children between Days 5 and 14. We utilized multivariable linear regression and stepwise model selection to develop a model to predict the probability of treatment failure or relapse.
RESULTS


Treatment failure or relapse occurred in 11.5% (61/526) of children included in this analysis. The final model incorporated the following predictors: heart rate terms, mid-upper arm circumference, malaria status, water source, family income, and whether or not a sibling or other child in the household received childcare outside the home. The model's area under the receiver operating characteristic score was 0.712 (95% confidence interval 0.66, 0.78) and it explained 6.1% of the variability in predicting treatment failure or relapse (R2, 0.061). For the model to categorize all children with treatment failure or relapse correctly, 77% of children without treatment failure or relapse would require antibiotics.
CONCLUSION


The model had inadequate discrimination to be appropriate for clinical application. Different strategies will likely be required for models to perform accurately among similar pediatric populations.",2019,"RESULTS


Treatment failure or relapse occurred in 11.5% (61/526) of children included in this analysis.","['children aged 2-59 months with World Health Organization fast breathing pneumonia in Malawi', 'treated Malawian children with World Health Organization ', 'Participants were low-risk HIV-uninfected children 2-59 months old with WHO fast breathing pneumonia in Lilongwe, Malawi']",['placebo'],"['failure or relapse', 'heart rate terms, mid-upper arm circumference, malaria status, water source, family income', 'disease progression at any time on or before Day 4 of treatment or disease persistence on Day 4, or relapse, considered as the recurrence of pneumonia or severe disease']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference (observable entity)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.0818636,"RESULTS


Treatment failure or relapse occurred in 11.5% (61/526) of children included in this analysis.","[{'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'McCollum', 'Affiliation': 'Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, School of Medicine, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Siobhan P', 'Initials': 'SP', 'LastName': 'Brown', 'Affiliation': 'Department of Biostatistics, University of Washington Clinical Trial Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Evangelyn', 'Initials': 'E', 'LastName': 'Nkwopara', 'Affiliation': 'Save the Children, Fairfield, Connecticut, United States of America.'}, {'ForeName': 'Tisungane', 'Initials': 'T', 'LastName': 'Mvalo', 'Affiliation': 'University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Lilongwe, Malawi.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'May', 'Affiliation': 'Department of Biostatistics, University of Washington Clinical Trial Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Amy Sarah', 'Initials': 'AS', 'LastName': 'Ginsburg', 'Affiliation': 'Save the Children, Fairfield, Connecticut, United States of America.'}]",PloS one,['10.1371/journal.pone.0214583']
426,30928147,PALS: peer support for community dwelling older people with chronic low back pain: a feasibility and acceptability study.,"OBJECTIVES


(i) Examine the feasibility and acceptability of a peer support intervention (PALS) to facilitate self-management in community dwelling older adults with Chronic Low Back Pain (CLBP), and (ii) examine the feasibility of study methods in order to inform the design of a future randomised controlled trial.
DESIGN


Mixed methods feasibility and acceptability study.
SETTING


Community.
PARTICIPANTS


18 older adults (aged 65 to 79) with CLBP and 6 peer support volunteers (PSVs) aged 34 to 65.
INTERVENTION


Six sessions of 1 to 3hours duration, approximately 2 weeks apart, delivered in mutually convenient public places, or by telephone. Each session had a suggested topic and each participant and PSV had a PALS manual detailing aims and target outcomes for each session.
OUTCOME MEASURES


Recruitment, retention, integrity, acceptability and feasibility of the PALS intervention, feasibility of study processes, appropriateness and usefulness of outcome measures.
RESULTS


We recruited to target and retained 2/3 of participants. PALS was delivered as intended and acceptable to people with CLBP and PSVs. Most participants were satisfied with PALS and would recommend it to someone else with CLBP. Study processes worked well, but recruitment procedures need to be refined. Outcome measures were returned and were mostly complete, but further work on the most appropriate measures is required.
CONCLUSIONS


PALS was feasible to deliver and acceptable to the older people and PSVs who took part in this study. We identified amendments to PALS and the study processes that, once implemented, will allow the effectiveness of PALS to be tested in a large-scale study.",2020,"(i) Examine the feasibility and acceptability of a peer support intervention (PALS) to facilitate self-management in community dwelling older adults with Chronic Low Back Pain (CLBP), and (ii) examine the feasibility of study methods in order to inform the design of a future randomised controlled trial.
","['Community', '18 older adults (aged 65 to 79) with CLBP and 6 peer support volunteers (PSVs) aged 34 to 65', 'community dwelling older adults with Chronic Low Back Pain (CLBP', 'community dwelling older people with chronic low back pain']",['peer support intervention (PALS'],"['Recruitment, retention, integrity, acceptability and feasibility of the PALS intervention, feasibility of study processes, appropriateness and usefulness of outcome measures']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",18.0,0.0942124,"(i) Examine the feasibility and acceptability of a peer support intervention (PALS) to facilitate self-management in community dwelling older adults with Chronic Low Back Pain (CLBP), and (ii) examine the feasibility of study methods in order to inform the design of a future randomised controlled trial.
","[{'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'School of Health Sciences, Robert Gordon University, Aberdeen, UK. Electronic address: k.cooper@rgu.ac.uk.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Schofield', 'Affiliation': 'Faculty of Health, Social Care & Education, Anglia Ruskin University, Chelmsford, UK.'}, {'ForeName': 'Blair H', 'Initials': 'BH', 'LastName': 'Smith', 'Affiliation': 'Division of Population Health Science, University of Dundee, Dundee, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Faculty of Health & Social Care, Robert Gordon University, Aberdeen, UK.'}]",Physiotherapy,['10.1016/j.physio.2019.01.015']
427,31970564,Photobiomodulation as an adjunctive therapy for alveolar socket preservation: a preliminary study in humans.,"Bone remodeling results in loss of alveolar bone height and thickness. Photobiomodulation (PBM) based on photochemical stimulation by low-intensity lasers emerges as an adjunctive therapy for alveolar socket preservation. Our study aimed to evaluate the effects of PBM therapy on alveolar bone repair. Twenty healthy patients in need of bilateral extraction of lower molars were enrolled in this split-mouth randomized and blind clinical trial. The extraction sites were randomly selected to receive either the PBM therapy with a CW GaAIAs diode laser (808 nm; 0.028 mm 2 ; 0.1 W; 3.6 W/cm 2 ; 89 J/cm 2 ; 2.5 J/point) or no treatment (Control). Bone biopsies were harvested 45 days after the dental extraction and evaluated using micro-computerized tomography (μCT), morphometric, and histological analysis. Data were compared using the paired t test, and the level of significance was set at 5%. Bone surface (p = 0.029), bone surface/total volume (p = 0.028), trabecular number (p = 0.025), and connectivity density (p = 0.029) were higher at the PBM group compared with Control. The histological observations confirmed the μCT findings. PBM samples exhibited higher number of organized and connected bone trabeculae along with higher density of blood vessels than Control. Control samples displayed a dense and highly cellular connective tissue at the central area accompanied by the presence of immature bone trabeculae at the periphery. Our results indicated that the PBM therapy improved the newly bone trabeculae formation and their connectivity which increased bone surface, indicating the positive effect of the laser on alveolar human socket repair.",2020,Control samples displayed a dense and highly cellular connective tissue at the central area accompanied by the presence of immature bone trabeculae at the periphery.,"['Twenty healthy patients in need of bilateral extraction of lower molars', 'humans']","['PBM therapy', 'PBM therapy with a CW GaAIAs diode laser', 'Photobiomodulation', 'Photobiomodulation (PBM']","['connectivity density', 'Bone surface', 'alveolar bone height and thickness', 'alveolar bone repair', 'trabecular number', 'bone surface/total volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0071006', 'cui_str': 'phytobacteriomycin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}]","[{'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",20.0,0.0400744,Control samples displayed a dense and highly cellular connective tissue at the central area accompanied by the presence of immature bone trabeculae at the periphery.,"[{'ForeName': 'Kleber Arturo Vallejo', 'Initials': 'KAV', 'LastName': 'Rosero', 'Affiliation': 'School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rui Manuel Freire', 'Initials': 'RMF', 'LastName': 'Sampaio', 'Affiliation': 'School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria Cristina Zindel', 'Initials': 'MCZ', 'LastName': 'Deboni', 'Affiliation': 'School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Corrêa', 'Affiliation': 'School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Márcia Martins', 'Initials': 'MM', 'LastName': 'Marques', 'Affiliation': 'School of Dentistry, Ibirapuera University, São Paulo, Brazil.'}, {'ForeName': 'Emanuela Prado', 'Initials': 'EP', 'LastName': 'Ferraz', 'Affiliation': 'School of Dentistry, University of São Paulo, São Paulo, Brazil. emanuelaferraz@usp.br.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'da Graça Naclério-Homem', 'Affiliation': 'School of Dentistry, University of São Paulo, São Paulo, Brazil.'}]",Lasers in medical science,['10.1007/s10103-020-02962-y']
428,29885777,Effect of baseline micronutrient and inflammation status on CD4 recovery post-cART initiation in the multinational PEARLS trial.,"BACKGROUND & AIMS


Nutritional deficiency and inflammation may impact CD4+ T cell recovery during combination antiretroviral therapy (cART), particularly in resource-limited settings where malnutrition is prevalent. The aim of this study was to investigate the relationship of micronutrient and inflammation biomarkers to CD4 recovery after cART initiation.
METHODS


We conducted a secondary analysis of a random sub-cohort sample (n = 270) from a multinational randomized trial of cART regimen efficacy among 1571 cART-naïve adults. We measured pre-cART serum levels of micronutrients (Vitamin A, B 6 , B 12 , D, total carotenoids, selenium, and iron) and inflammation (C-reactive protein, soluble CD14 (sCD14), IFNγ, TNFα, Interleukin-6, and C-X-C motif chemokine 10 (CXCL10/IP10), EndoCab (IgM)) biomarkers. Biomarker status (i.e. micronutrient deficiency vs. sufficiency and elevated vs. low inflammation) was defined using established cutoffs or quartiles. Mixed-effects linear regression models were used to determine the association of baseline (pre-cART) concentrations of individual biomarkers with CD4 recovery through 96 weeks post-cART initiation.
RESULTS


In models adjusting for time-dependent viral load and baseline CD4 count, age, sex, body mass index, country, treatment regimen, anemia and hypoalbuminemia status, pre-cART vitamin D deficiency was associated with lower CD4 recovery (-14.9 cells/mm 3 , 95% CI: -27.9, -1.8) compared to sufficiency. In contrast, baseline selenium deficiency (20.8 cells/mm 3 , 95% CI: 3.3, 38.3), vitamin A deficiency (35.9 cells/mm 3 , 95% CI: 17.6, 54.3) and high sCD14 (23.4 cells/mm 3 , 95% CI: 8.9, 37.8) were associated with higher CD4 recovery compared to sufficient/low inflammation status.
CONCLUSIONS


In summary, baseline vitamin D deficiency was associated with diminished CD4 recovery after cART initiation; impaired CD4 recovery may contribute to the poor clinical outcomes recently observed in individuals with vitamin D deficiency. Vitamin A, selenium and sCD14 were associated with CD4 recovery but future studies are needed to further explore these relationships.",2019,"Vitamin A, selenium and sCD14 were associated with CD4 recovery but future studies are needed to further explore these relationships.","['random sub-cohort sample (n\xa0=\xa0270', '1571 cART-naïve adults']","['cART', 'combination antiretroviral therapy (cART']","['CD4 recovery', 'baseline selenium deficiency', 'pre-cART serum levels of micronutrients (Vitamin A, B 6 , B 12 , D, total carotenoids, selenium, and iron) and inflammation (C-reactive protein, soluble CD14 (sCD14), IFNγ, TNFα, Interleukin-6, and C-X-C motif chemokine 10 (CXCL10/IP10), EndoCab (IgM)) biomarkers', 'vitamin A deficiency']","[{'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0238421', 'cui_str': 'Selenium deficiency (disorder)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0042842', 'cui_str': 'Vitamin A Deficiency'}]",,0.325259,"Vitamin A, selenium and sCD14 were associated with CD4 recovery but future studies are needed to further explore these relationships.","[{'ForeName': 'Rupak', 'Initials': 'R', 'LastName': 'Shivakoti', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA. Electronic address: rshivak1@jhmi.edu.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Ewald', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: erewald@gmail.com.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Gupte', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA. Electronic address: nikhil_jhumit@yahoo.com.'}, {'ForeName': 'Wei-Teng', 'Initials': 'WT', 'LastName': 'Yang', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA. Electronic address: weiteng.yang@gmail.com.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Kanyama', 'Affiliation': 'UNC Lilongwe, Lilongwe, Malawi. Electronic address: ckanyama@unclilongwe.org.'}, {'ForeName': 'Sandra W', 'Initials': 'SW', 'LastName': 'Cardoso', 'Affiliation': 'STD/AIDS Clinical Research Laboratory, Instituto de Pesquisa Clinica Evandro Chagas, Fundacao Oswaldo Cruz, Rio de Janeiro, Brazil. Electronic address: sandra.wagner@ipec.fiocruz.br.'}, {'ForeName': 'Breno', 'Initials': 'B', 'LastName': 'Santos', 'Affiliation': 'Hospital Nossa Senhora de Conceição, Porto Alegre, Brazil. Electronic address: breno@ghc.com.br.'}, {'ForeName': 'Khuanchai', 'Initials': 'K', 'LastName': 'Supparatpinyo', 'Affiliation': 'Chiang Mai University, Chiang Mai, Thailand. Electronic address: khuanchai@rihes.org.'}, {'ForeName': 'Sharlaa', 'Initials': 'S', 'LastName': 'Badal-Faesen', 'Affiliation': 'Department of Medicine, University of Witwatersrand, Johannesburg, South Africa. Electronic address: sfaesen@witshealth.co.za.'}, {'ForeName': 'Javier R', 'Initials': 'JR', 'LastName': 'Lama', 'Affiliation': 'IMPACT PERU Clinical Trials Unit, Asociacion Civil Impacta Salud y Educacion, Lima, Peru. Electronic address: jrlama@impactaperu.org.'}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Lalloo', 'Affiliation': 'University of KwaZulu Natal, Nelson R Mandela School of Medicine, Durban, South Africa. Electronic address: umeshlalloo@gmail.com.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Zulu', 'Affiliation': 'Malawi College of Medicine - Johns Hopkins Research Project, Kachere Rehabilitation Centre, Blantyre, Malawi. Electronic address: nez4@cdc.gov.'}, {'ForeName': 'Jyoti S', 'Initials': 'JS', 'LastName': 'Pawar', 'Affiliation': 'National AIDS Research Institute, Pune, India. Electronic address: jyotispawar.pawar@gmail.com.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Riviere', 'Affiliation': 'Les Centres GHESKIO, Port-Au-Prince, Haiti. Electronic address: cynthiariviere@yahoo.com.'}, {'ForeName': 'Nagalingeswaran', 'Initials': 'N', 'LastName': 'Kumarasamy', 'Affiliation': 'YR Gaitonde Center for AIDS Research and Education, Chennai, India. Electronic address: kumarasamy@yrgcare.org.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hakim', 'Affiliation': 'University of Zimbabwe, Harare, Zimbabwe. Electronic address: jhakim@mweb.co.zw.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pollard', 'Affiliation': 'Department of Medicine, University of California Davis, Sacramento, CA, USA. Electronic address: rbpollard@ucdavis.edu.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Detrick', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: bdetrick@jhmi.edu.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Balagopal', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA. Electronic address: abalago1@jhmi.edu.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Asmuth', 'Affiliation': 'Department of Medicine, University of California Davis, Sacramento, CA, USA. Electronic address: dasmuth@ucdavis.edu.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Semba', 'Affiliation': 'Department of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: rdsemba@jhmi.edu.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Colorado School of Medicine, Aurora, CO, USA. Electronic address: Thomas.Campbell@ucdenver.edu.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Golub', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA. Electronic address: jgolub@jhmi.edu.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA. Electronic address: agupta25@jhmi.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.05.014']
429,31970939,"Safety, Tolerability, Pharmacokinetics, and Food Effects on TAC-302 in Healthy Participants: Randomized, Double-Blind, Placebo-Controlled, Single-Dose and Multiple-Dose Studies.","TAC-302 stimulates neurite outgrowth activity and is expected to restore urinary function in patients with lower urinary tract dysfunction. We conducted 2 phase 1, randomized, placebo-controlled studies to confirm the safety and pharmacokinetics (PK) of TAC-302 in healthy adult Japanese male volunteers. In the first-in-human single-dose study (n = 60), TAC-302 was administered at doses from 100 to 1200 mg after an overnight fast. The effects of a meal on the PK of TAC-302 400 mg were also examined. A multiple-dose study (n = 36) evaluated the effects of meal fat content on the PK of single doses of TAC-302 (100, 200, or 400 mg) and multiple doses of TAC-302 administered for 5 days (100, 200, and 400 mg twice daily). TAC-302 showed linear PK up to doses of 1200 mg in the fasting state, and across the dose range of 100-400 mg in the fed state. No accumulation of TAC-302 was observed. Food, particularly with high fat content, increased TAC-302 plasma concentrations. No differences were observed in the adverse event incidence between the TAC-302 and placebo groups in either study. TAC-302 showed a wide safety margin.",2020,"TAC-302 showed linear PK up to doses of 1200 mg in the fasting state, and across the dose range of 100-400 mg in the fed state.","['healthy adult Japanese male volunteers', 'Healthy Participants', 'patients with lower urinary tract dysfunction']","['Placebo', 'placebo', 'TAC-302']","['Safety, Tolerability, Pharmacokinetics, and Food Effects', 'adverse event incidence', 'TAC-302 plasma concentrations', 'safety and pharmacokinetics (PK', 'accumulation of TAC-302']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure (body structure)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0894403,"TAC-302 showed linear PK up to doses of 1200 mg in the fasting state, and across the dose range of 100-400 mg in the fed state.","[{'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Sesoko', 'Affiliation': 'Sosenkai Clinic Edogawa, Mizue, Edogawa-ku, Tokyo, Japan.'}, {'ForeName': 'Jinhong', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Pharmacovigilance Department, Taiho Pharmaceutical Co., Ltd., Uchikanda, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Takashige', 'Initials': 'T', 'LastName': 'Okayama', 'Affiliation': 'Pharmacokinetics Research Laboratories, Taiho Pharmaceutical Co., Ltd., Okubo, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Nishida', 'Affiliation': 'Clinical Development II Department, Taiho Pharmaceutical Co., Ltd., Uchikanda, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Miyoshi', 'Affiliation': 'Clinical Development II Department, Taiho Pharmaceutical Co., Ltd., Uchikanda, Chiyoda-ku, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.776']
430,31150976,Per- and polyfluoroalkyl substances and blood lipid levels in pre-diabetic adults-longitudinal analysis of the diabetes prevention program outcomes study.,"Exposure to per- and polyfluoroalkyl substances (PFASs) may interfere with lipid regulation. However, most previous studies were cross-sectional with the risk of reverse causation, suggesting a need for long-term prospective studies. We examined the relationship of baseline plasma PFAS concentrations with repeated measures of blood lipids. We included 888 prediabetic adults from the Diabetes Prevention Program (DPP) and DPP Outcomes Study, who had measurements of 6 plasma PFAS concentrations at baseline (1996-1999) and repeated measures of blood lipids over 15 years of follow-up, and were initially randomized to placebo or a lifestyle intervention. We used linear regression to examine cross-sectional associations of PFAS concentrations and lipid levels at baseline, and evaluated prospective risks of hypercholesterolemia and hypertriglyceridemia using Cox proportional hazard models, and tested for effect modification by study arm. Participants (65.9% female, 57.0% White, 65.9% aged 40-59 years) had comparable PFAS concentrations [e.g., median (IQR) perfluorooctanoic acid (PFOA) 4.9 ng/mL (3.2)] with the general U.S. population in 1999-2000. We observed higher total cholesterol at baseline per doubling of PFOA (β: 6.1 mg/dL, 95% CI: 3.1, 9.04), perfluorohexane sulfonic acid (PFHxS, β: 2.2 mg/dL, 95% CI: 0.2, 4.3), and perfluorononanoic acid (PFNA, β: 2.9 mg/dL, 95% CI: 0.7, 5.0). Prospectively, baseline concentrations of several PFASs, including PFOA, PFOS, PFHxS and PFNA, predicted higher risks of incident hypercholesterolemia and hypertriglyceridemia, but only in the placebo group and not the lifestyle intervention group. For example, participants in the placebo group with PFOA concentration > median (4.9 ng/mL) were almost twice as likely (HR: 1.90, 95% CI: 1.25, 2.88) to develop hypertriglyceridemia compared to those ≤median. Findings suggest adverse effects of some PFASs on lipid profiles in prediabetic adults. However, the detrimental effect was attenuated with a lifestyle intervention.",2019,"(PFHxS, β: 2.2 mg/dL, 95% CI: 0.2, 4.3), and perfluorononanoic acid (PFNA, β: 2.9 mg/dL, 95% CI: 0.7, 5.0).","['Participants (65.9% female, 57.0% White, 65.9% aged 40-59\u202fyears) had comparable PFAS concentrations [e.g., median (IQR) perfluorooctanoic acid (PFOA) 4.9\u202fng/mL (3.2)] with the general U.S. population in 1999-2000', 'pre-diabetic adults', '888 prediabetic adults from the Diabetes Prevention Program (DPP) and DPP Outcomes Study, who had measurements of 6 plasma PFAS concentrations at baseline (1996-1999) and repeated measures of blood lipids over 15\u202fyears of follow-up', 'prediabetic adults']","['Per- and polyfluoroalkyl substances', 'placebo', 'perfluorohexane sulfonic acid', 'placebo or a lifestyle intervention', 'per- and polyfluoroalkyl substances (PFASs']","['baseline concentrations of several PFASs, including PFOA, PFOS, PFHxS and PFNA, predicted higher risks of incident hypercholesterolemia and hypertriglyceridemia', 'blood lipid levels', 'total cholesterol', 'PFOA concentration\u202f>\u202fmedian', 'lipid profiles', 'hypertriglyceridemia']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0070403', 'cui_str': 'perfluorooctanoic acid'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1176320', 'cui_str': 'perflexane'}, {'cui': 'C0038762', 'cui_str': 'Sulfonic Acids'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0005768'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]",888.0,0.17023,"(PFHxS, β: 2.2 mg/dL, 95% CI: 0.2, 4.3), and perfluorononanoic acid (PFNA, β: 2.9 mg/dL, 95% CI: 0.7, 5.0).","[{'ForeName': 'Pi-I D', 'Initials': 'PD', 'LastName': 'Lin', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Cardenas', 'Affiliation': 'Division of Environmental Health Sciences, School of Public Health, University of California, Berkeley, CA, USA.'}, {'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'Hauser', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Diane R', 'Initials': 'DR', 'LastName': 'Gold', 'Affiliation': ""Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Ken P', 'Initials': 'KP', 'LastName': 'Kleinman', 'Affiliation': 'Department of Biostatistics, School of Public Health and Human Sciences, University of Massachusetts Amherst, Amherst, MA, USA.'}, {'ForeName': 'Marie-France', 'Initials': 'MF', 'LastName': 'Hivert', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA; Diabetes Unit, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Abby F', 'Initials': 'AF', 'LastName': 'Fleisch', 'Affiliation': 'Pediatric Endocrinology and Diabetes, Maine Medical Center, Portland, ME, USA; Center for Outcomes Research and Evaluation, Maine Medical Center Research Institute, Portland, ME, USA.'}, {'ForeName': 'Antonia M', 'Initials': 'AM', 'LastName': 'Calafat', 'Affiliation': 'Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Webster', 'Affiliation': 'Department of Environmental Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Horton', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Oken', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA. Electronic address: emily_oken@harvardpilgrim.org.'}]",Environment international,['10.1016/j.envint.2019.05.027']
431,30595143,"A group-based yoga program for urinary incontinence in ambulatory women: feasibility, tolerability, and change in incontinence frequency over 3 months in a single-center randomized trial.","BACKGROUND


Because of the limitations of existing clinical treatments for urinary incontinence, many women with incontinence are interested in complementary strategies for managing their symptoms. Yoga has been recommended as a behavioral self-management strategy for incontinence, but evidence of its feasibility, tolerability, and efficacy is lacking.
OBJECTIVE


To evaluate the feasibility and tolerability of a group-based therapeutic yoga program for ambulatory middle-aged and older women with incontinence, and to examine preliminary changes in incontinence frequency as the primary efficacy outcome after 3 months.
MATERIALS AND METHODS


Ambulatory women aged 50 years or older who reported at least daily stress-, urgency-, or mixed-type incontinence, were not already engaged in yoga, and were willing to temporarily forgo clinical incontinence treatments were recruited into a randomized trial in the San Francisco Bay area. Women were randomly assigned to take part in a program of twice-weekly group classes and once-weekly home practice focused on Iyengar-based yoga techniques selected by an expert yoga panel (yoga group), or a nonspecific muscle stretching and strengthening program designed to provide a rigorous time-and-attention control (control group) for 3 months. All participants also received written, evidence-based information about behavioral incontinence self-management techniques (pelvic floor exercises, bladder training) consistent with usual first-line care. Incontinence frequency and type were assessed by validated voiding diaries. Analysis of covariance models examined within- and between-group changes in incontinence frequency as the primary efficacy outcome over 3 months.
RESULTS


Of the 56 women randomized (28 to yoga, 28 to control), the mean age was 65.4 (±8.1) years (range, 55-83 years), the mean baseline incontinence frequency was 3.5 (±2.0) episodes/d, and 37 women (66%) had urgency-predominant incontinence. A total of 50 women completed their assigned 3-month intervention program (89%), including 27 in the yoga and 23 in the control group (P = .19). Of those, 24 (89%) in the yoga and 20 (87%) in the control group attended at least 80% of group classes. Over 3 months, total incontinence frequency decreased by an average of 76% from baseline in the yoga and 56% in the control group (P = .07 for between-group difference). Stress incontinence frequency also decreased by an average of 61% in the yoga group and 35% in controls (P = .045 for between-group difference), but changes in urgency incontinence frequency did not differ significantly between groups. A total of 48 nonserious adverse events were reported, including 23 in the yoga and 25 in the control group, but none were directly attributable to yoga or control program practice.
CONCLUSION


Findings demonstrate the feasibility of recruiting and retaining incontinent women across the aging spectrum into a therapeutic yoga program, and provide preliminary evidence of reduction in total and stress-type incontinence frequency after 3 months of yoga practice. When taught with attention to women's clinical needs, yoga may offer a potential community-based behavioral self-management strategy for incontinence to enhance clinical treatment, although future research should assess whether yoga offers unique benefits for incontinence above and beyond other physical activity-based interventions.",2019,"Stress incontinence frequency also decreased by an average of 61% in the yoga group and 35% in controls (P = .045 for between-group difference), but changes in urgency incontinence frequency did not differ significantly between groups.","['ambulatory middle-aged and older women with incontinence', 'ambulatory women', 'Ambulatory women aged 50 years or older who reported at least daily stress-, urgency-, or mixed-type incontinence, were not already engaged in yoga, and were willing to temporarily forgo clinical incontinence treatments were recruited into a randomized trial in the San Francisco Bay area', '50 women', '56 women randomized (28 to yoga, 28 to control', 'mean age was 65.4 (±8.1) years (range, 55-83 years), the mean baseline incontinence frequency was 3.5 (±2.0) episodes/d, and 37 women (66%) had urgency-predominant incontinence']","['yoga program', 'group-based therapeutic yoga program', 'written, evidence-based information about behavioral incontinence self-management techniques (pelvic floor exercises, bladder training) consistent with usual first-line care', 'program of twice-weekly group classes and once-weekly home practice focused on Iyengar-based yoga techniques selected by an expert yoga panel (yoga group), or a nonspecific muscle stretching and strengthening program designed to provide a rigorous time-and-attention control (control group']","['total incontinence frequency', 'feasibility and tolerability', 'total and stress-type incontinence frequency', 'Stress incontinence frequency', 'urgency incontinence frequency']","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0026062', 'cui_str': 'Middle Age'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0262718', 'cui_str': 'Pelvic muscle exercises'}, {'cui': 'C0150474', 'cui_str': 'Urinary bladder training'}, {'cui': 'C0332290', 'cui_str': 'Consistent with (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0401155', 'cui_str': 'Double incontinence (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}]",50.0,0.0624505,"Stress incontinence frequency also decreased by an average of 61% in the yoga group and 35% in controls (P = .045 for between-group difference), but changes in urgency incontinence frequency did not differ significantly between groups.","[{'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Huang', 'Affiliation': 'Department of Medicine, University of California, San Francisco, CA; Department of Epidemiology & Biostatistics, University of California, San Francisco, CA. Electronic address: Alison.Huang@ucsf.edu.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Chesney', 'Affiliation': 'Department of Medicine, University of California, San Francisco, CA.'}, {'ForeName': 'Nadra', 'Initials': 'N', 'LastName': 'Lisha', 'Affiliation': 'Department of Medicine, University of California, San Francisco, CA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, CA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schembri', 'Affiliation': 'Department of Obstetrics, Gynecology, & Reproductive Sciences, University of California, San Francisco, CA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pawlowsky', 'Affiliation': 'Department of Physical Therapy, San Francisco State University, San Francisco, CA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hsu', 'Affiliation': 'Geriatric Medicine, Palo Alto Medical Foundation, Palo Alto, CA.'}, {'ForeName': 'Leslee', 'Initials': 'L', 'LastName': 'Subak', 'Affiliation': 'Department of Obstetrics & Gynecology, Stanford University, Palo Alto, CA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2018.10.031']
432,31975494,Biventricular pacemaker therapy improves exercise capacity in patients with non-obstructive hypertrophic cardiomyopathy via augmented diastolic filling on exercise.,"AIMS


Treatment options for patients with non-obstructive hypertrophic cardiomyopathy (HCM) are limited. We sought to determine whether biventricular (BiV) pacing improves exercise capacity in HCM patients, and whether this is via augmented diastolic filling.
METHODS AND RESULTS


Thirty-one patients with symptomatic non-obstructive HCM were enrolled. Following device implantation, patients underwent detailed assessment of exercise diastolic filling using radionuclide ventriculography in BiV and sham pacing modes. Patients then entered an 8-month crossover study of BiV and sham pacing in random order, to assess the effect on exercise capacity [peak oxygen consumption (VO 2  )]. Patients were grouped on pre-specified analysis according to whether left ventricular end-diastolic volume increased (+LVEDV) or was unchanged/decreased (-LVEDV) with exercise at baseline. Twenty-nine patients (20 male, mean age 55 years) completed the study. There were 14 +LVEDV patients and 15 -LVEDV patients. Baseline peak VO 2  was lower in -LVEDV patients vs. +LVEDV patients (16.2 ± 0.9 vs. 19.9 ± 1.1 mL/kg/min, P = 0.04). BiV pacing significantly increased exercise ΔLVEDV (P = 0.004) and Δstroke volume (P = 0.008) in -LVEDV patients, but not in +LVEDV patients. Left ventricular ejection fraction and end-systolic elastance did not increase with BiV pacing in either group. This translated into significantly greater improvements in exercise capacity (peak VO 2   + 1.4 mL/kg/min, P = 0.03) and quality of life scores (P = 0.02) in -LVEDV patients during the crossover study. There was no effect on left ventricular mechanical dyssynchrony in either group.
CONCLUSION


Symptomatic patients with non-obstructive HCM may benefit from BiV pacing via augmentation of diastolic filling on exercise rather than contractile improvement. This may be due to relief of diastolic ventricular interaction.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT00504647.",2020,"BiV pacing significantly increased exercise ΔLVEDV (P = 0.004) and Δstroke volume (P = 0.008) in -LVEDV patients, but not in +LVEDV patients.","['patients with non-obstructive hypertrophic cardiomyopathy via augmented diastolic filling on exercise', 'patients with non-obstructive hypertrophic cardiomyopathy (HCM', 'Symptomatic patients with non-obstructive HCM', 'HCM patients', 'Thirty-one patients with symptomatic non-obstructive HCM were enrolled', 'Twenty-nine patients (20 male, mean age 55\u2009years) completed the study']","['biventricular (BiV) pacing', 'Biventricular pacemaker therapy', 'exercise diastolic filling using radionuclide ventriculography in BiV and sham pacing modes', 'BiV and sham pacing']","['Left ventricular ejection fraction and end-systolic elastance', 'Baseline peak VO 2', 'exercise capacity [peak oxygen consumption (VO 2  ', 'exercise capacity', 'BiV pacing', 'left ventricular mechanical dyssynchrony', 'Δstroke volume', 'quality of life scores', 'left ventricular end-diastolic volume increased (+LVEDV', 'exercise ΔLVEDV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205304', 'cui_str': 'Non-obstructive (qualifier value)'}, {'cui': 'C0007194', 'cui_str': 'Hypertrophic Cardiomyopathy'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2936372', 'cui_str': 'Atrio-Biventricular Pacing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034610', 'cui_str': 'Radionuclide Ventriculography'}, {'cui': 'C0079031', 'cui_str': 'BIV'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}]","[{'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0079031', 'cui_str': 'BIV'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",31.0,0.0860411,"BiV pacing significantly increased exercise ΔLVEDV (P = 0.004) and Δstroke volume (P = 0.008) in -LVEDV patients, but not in +LVEDV patients.","[{'ForeName': 'Ibrar', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Department of Cardiovascular Medicine, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Brodie L', 'Initials': 'BL', 'LastName': 'Loudon', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Abozguia', 'Affiliation': 'Department of Cardiovascular Medicine, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Donnie', 'Initials': 'D', 'LastName': 'Cameron', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Ganesh N', 'Initials': 'GN', 'LastName': 'Shivu', 'Affiliation': 'Department of Cardiovascular Medicine, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Thanh T', 'Initials': 'TT', 'LastName': 'Phan', 'Affiliation': 'Department of Cardiovascular Medicine, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Maher', 'Affiliation': 'Department of Cardiovascular Medicine, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Stegemann', 'Affiliation': 'Bakken Research Centre, Medtronic Inc., Maastricht, The Netherlands.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Chow', 'Affiliation': 'Department of Cardiovascular Medicine, Royal Berkshire NHS Foundation Trust, Reading, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Marshall', 'Affiliation': 'Queen Elizabeth Hospital Birmingham, Welcome Trust Clinical Research Facility, Birmingham, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nightingale', 'Affiliation': 'Queen Elizabeth Hospital Birmingham, Welcome Trust Clinical Research Facility, Birmingham, UK.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Leyva', 'Affiliation': 'Department of Cardiovascular Medicine, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Vassilios S', 'Initials': 'VS', 'LastName': 'Vassiliou', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'McKenna', 'Affiliation': 'Institute of Cardiovascular Science, University College of London, London, UK.'}, {'ForeName': 'Perry', 'Initials': 'P', 'LastName': 'Elliott', 'Affiliation': 'Institute of Cardiovascular Science, University College of London, London, UK.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Frenneaux', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}]",European journal of heart failure,['10.1002/ejhf.1722']
433,31862312,"Pharmacokinetics, pharmacodynamics and safety of a novel extrafine BDP/FF/GB combination delivered via metered-dose inhaler in healthy Chinese subjects.","BACKGROUND


BDP/FF/GB pMDI is a novel triple fixed-dose combination of extra-fine inhalation aerosol beclomethasone dipropionate (BDP)/formoterol fumarate (FF)/glycopyrronium bromide (GB). Limited data on the pharmacokinetic (PK) and pharmacodynamic (PD) properties of BDP/FF/GB fixed-dose combination in healthy subjects was available.
PURPOSES


This study aimed to evaluate the pharmacokinetics, pharmacodynamics and safety of BDP/FF/GB pMDI in healthy Chinese subjects.
METHODS


This is an open-label, parallel-group, randomized, single and multiple dose study. In the single dose group, subjects received single supra-therapeutic inhaled dose of BDP/FF/GB pMDI (BDP/FF/GB 400/24/50 µg). In the multiple dose group, subjects received therapeutic inhaled dose of BDP/FF/GB pMDI (BDP/FF/GB 200/12/25 µg), twice daily, for 7 consecutive days. Plasma BDP, B17MP, formoterol and GB were determined by a validated ultra performance liquid chromatography method with tandem mass spectrometric detection (UPLC/MS-MS). Heart rate (HR), QTcF, systolic blood pressure (SBP) and diastolic blood pressure (DBP) were evaluated as the surrogate indicators of pharmacodynamic effects.
RESULTS


A total of 24 subjects were randomized and 22 (11 in each group) completed the study. The dose adjusted pharmacokinetic profiles of BDP, beclomethasone-17-monopropionate (B17MP, the most active metabolite of BDP), formoterol and GB were overall similar in therapeutic and supra- therapeutic dose group, showing dose proportional increase of the systemic exposure to BDP, B17MP, formoterol and GB. The pharmacodynamic variables were within the normal range and showed no significant difference between the two groups. All the treatment-emergent adverse events (TEAEs) were mild and no severe TEAE was reported.
CONCLUSIONS


Dose adjusted PK profiles were similar between therapeutic and supra-therapeutic dose for all compounds, nearly dose proportional systemic exposure to B17MP, formoterol and GB after BDP/FF/GB pMDI administration in healthy Chinese subjects. BDP/FF/GB pMDI was safe and well tolerated in healthy Chinese subjects. The PK profiles were comparable to previously published data from Western European healthy Caucasian subjects.",2020,"CONCLUSIONS


Dose adjusted PK profiles were similar between therapeutic and supra-therapeutic dose for all compounds, nearly dose proportional systemic exposure to B17MP, formoterol and GB after BDP/FF/GB pMDI administration in healthy Chinese subjects.","['24 subjects were randomized and 22 (11 in each group) completed the study', 'healthy Chinese subjects', 'healthy subjects', 'European healthy Caucasian subjects']","['BDP/FF/GB pMDI', 'novel extrafine BDP/FF/GB combination', 'beclomethasone-17-monopropionate', 'beclomethasone dipropionate (BDP)/formoterol fumarate (FF)/glycopyrronium bromide (GB', 'therapeutic inhaled dose of BDP/FF/GB pMDI', 'single supra-therapeutic inhaled dose of BDP/FF/GB pMDI']","['pharmacokinetic (PK) and pharmacodynamic (PD) properties', 'Plasma BDP, B17MP, formoterol and GB', 'Heart rate (HR), QTcF, systolic blood pressure (SBP) and diastolic blood pressure (DBP', 'Pharmacokinetics, pharmacodynamics and safety', 'safe and well tolerated']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0081729', 'cui_str': 'beclomethasone 17-monopropionate'}, {'cui': 'C0004906', 'cui_str': 'Beclomethasone Dipropionate'}, {'cui': 'C0220833', 'cui_str': 'fumarate'}, {'cui': 'C0006222', 'cui_str': 'Bromides'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",24.0,0.0957088,"CONCLUSIONS


Dose adjusted PK profiles were similar between therapeutic and supra-therapeutic dose for all compounds, nearly dose proportional systemic exposure to B17MP, formoterol and GB after BDP/FF/GB pMDI administration in healthy Chinese subjects.","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'GCP Center / Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': 'GCP Center / Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Shiqing', 'Initials': 'S', 'LastName': 'Shu', 'Affiliation': 'GCP Center / Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'GCP Center / Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'GCP Center / Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': 'GCP Center / Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu 610041, PR China. Electronic address: luozhu720@163.com.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2019.105198']
434,31964186,High-intensity interval training is effective and superior to moderate continuous training in patients with heart failure with preserved ejection fraction: A randomized clinical trial.,"BACKGROUND


Heart failure with preserved ejection fraction (HFpEF) is a prevalent syndrome, with exercise intolerance being one of its hallmarks, contributing to worse quality of life and mortality. High-intensity interval training is an emerging training option, but its efficacy in HFpEF patients is still unknown.
DESIGN


Single-blinded randomized clinical trial.
METHODS


Single-blinded randomized clinical trial with exercise training 3 days per week for 12 weeks. HFpEF patients were randomly assigned to high-intensity interval training or moderate continuous training. At baseline and after 12 week follow-up, patients underwent clinical assessment, echocardiography and cardiopulmonary exercise testing (CPET).
RESULTS


Mean age was 60 ± 9 years and 63% were women. Both groups ( N  = 19) showed improved peak oxygen consumption (VO 2 ), but high-intensity interval training patients ( n  = 10) had a significantly higher increase, of 22%, compared with 11% in the moderate continuous training ( n  = 9) individuals (3.5 (3.1 to 4.0)  vs . 1.9 (1.2 to 2.5) mL·kg -1 ·min -1 ,  p  < 0.001). Ventilatory efficiency and other CPET measures, as well as quality of life score, increased equally in the two groups. Left ventricular diastolic function also improved with training, reflected by a significant reduction in E/e' ratio by echocardiography (-2.6 (-4.3 to -1.0)  vs . -2.2 (-3.6 to -0.9) for high-intensity interval training and moderate continuous training, respectively;  p  < 0.01). There were no exercise-related adverse events.
CONCLUSIONS


This randomized clinical trial provided evidence that high-intensity interval training is a potential exercise modality for HFpEF patients, being more effective than moderate continuous training in improving peak VO 2 . However, the two strategies were equally effective in improving ventilatory efficiency and other CPET parameters, quality of life score and diastolic function after 3 months of training.",2020,"Ventilatory efficiency and other CPET measures, as well as quality of life score, increased equally in the two groups.","['Mean age was 60\u2009±\u20099 years and 63% were women', 'HFpEF patients', 'patients with heart failure with preserved ejection fraction']","['high-intensity interval training or moderate continuous training', 'High-intensity interval training', 'exercise training', 'echocardiography and cardiopulmonary exercise testing (CPET', 'high-intensity interval training']","['Ventilatory efficiency and other CPET measures', 'ventilatory efficiency and other CPET parameters, quality of life score and diastolic function', 'quality of life score', 'peak oxygen consumption', ""E/e' ratio by echocardiography"", 'Left ventricular diastolic function']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0055954', 'cui_str': 'CPET'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0055954', 'cui_str': 'CPET'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}]",,0.0739176,"Ventilatory efficiency and other CPET measures, as well as quality of life score, increased equally in the two groups.","[{'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Donelli da Silveira', 'Affiliation': 'Division of Cardiology, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Beust de Lima', 'Affiliation': 'Exercise Cardiology Research Group (CardioEX), Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Division of Rehabilitation, Porto Alegre, Brazil.'}, {'ForeName': 'Diogo', 'Initials': 'D', 'LastName': 'da Silva Piardi', 'Affiliation': 'Post Graduate Studies Program in Cardiology, School of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Débora', 'Initials': 'D', 'LastName': 'Dos Santos Macedo', 'Affiliation': 'Exercise Cardiology Research Group (CardioEX), Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Division of Rehabilitation, Porto Alegre, Brazil.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Zanini', 'Affiliation': 'Exercise Cardiology Research Group (CardioEX), Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Division of Rehabilitation, Porto Alegre, Brazil.'}, {'ForeName': 'Rosane', 'Initials': 'R', 'LastName': 'Nery', 'Affiliation': 'Exercise Cardiology Research Group (CardioEX), Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Division of Rehabilitation, Porto Alegre, Brazil.'}, {'ForeName': 'Jari A', 'Initials': 'JA', 'LastName': 'Laukkanen', 'Affiliation': 'Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Stein', 'Affiliation': 'Exercise Cardiology Research Group (CardioEX), Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Division of Rehabilitation, Porto Alegre, Brazil.'}]",European journal of preventive cardiology,['10.1177/2047487319901206']
435,30419120,"Placebo vs Amoxicillin for Nonsevere Fast-Breathing Pneumonia in Malawian Children Aged 2 to 59 Months: A Double-blind, Randomized Clinical Noninferiority Trial.","Importance


Pneumonia is the leading infectious killer of children. Rigorous evidence supporting antibiotic treatment of children with nonsevere fast-breathing pneumonia in low-resource African settings is lacking.
Objective


To assess whether treatment with placebo for nonsevere fast-breathing pneumonia is substantively less effective than 3 days of treatment with amoxicillin.
Design, Setting, and Participants


This double-blind, 2-arm, randomized clinical noninferiority trial with follow-up of 14 days screened 1343 HIV-uninfected children aged 2 to 59 months with nonsevere fast-breathing pneumonia at outpatient departments of hospitals in Lilongwe, Malawi, Africa, between June 2016 and June 2017.
Interventions


Placebo or amoxicillin dispersible tablets administered twice daily for 3 days.
Main Outcomes and Measures


The primary end point was the proportion of children failing treatment by day 4 with a relative noninferiority margin of 1.5 times the failure rate in the amoxicillin group. Primary analyses were performed based on the intention-to-treat principle. Planned secondary analyses included treatment failure or relapse by day 14.
Results


In total, 1126 children were randomized to 3 days of amoxicillin (n = 564) or placebo (n = 562) therapy. Baseline demographic and clinical characteristics were similar between the groups. For the entire study population, the mean (SD) age was 21.3 (15.1) months, and 601 (53.4%) were female. After an interim analysis, the data safety monitoring board stopped the study because children receiving amoxicillin had a 4.0% (22 of 552 with outcome data) treatment failure rate by day 4, whereas children receiving placebo had a 7.0% (38 of 543) treatment failure rate (adjusted relative risk, 1.78; 95% CI, 1.07%-2.97%; adjusted absolute difference, 3.0%; 95% CI, 0.4%-5.7%). Among children with known day 14 outcomes, 56 of 552 (10.1%) receiving amoxicillin and 64 of 543 (11.8%) receiving placebo had either treatment failure by day 4 or relapse by day 14 (relative risk, 1.16; 95% CI, 0.83%-1.63%; absolute difference, 1.6%; 95% CI, -2.1% to 5.4%). There were no deaths.
Conclusions and Relevance


In HIV-uninfected children aged 2 to 59 months in a malaria-endemic region of Malawi, placebo treatment of nonsevere fast-breathing pneumonia was significantly inferior to treatment with amoxicillin. However, by day 4, approximately 93% of children receiving placebo were without treatment failure, and there was no significant difference between groups in treatment failure or relapse by day 14. The number of children with nonsevere fast-breathing pneumonia that needed amoxicillin treatment for 1 child to benefit was 33.
Trial Registration


ClinicalTrials.gov Identifier: NCT02760420.",2019,"There were no deaths.
","['1126 children', 'Malawian Children Aged 2 to 59 Months', 'For the entire study population, the mean (SD) age was 21.3 (15.1) months, and 601 (53.4%) were female', 'children with nonsevere fast-breathing pneumonia in low-resource African settings', '14 days screened 1343 HIV-uninfected children aged 2 to 59 months with nonsevere fast-breathing pneumonia at outpatient departments of hospitals in Lilongwe, Malawi, Africa, between June 2016 and June 2017']","['Placebo vs Amoxicillin', 'amoxicillin', 'placebo', 'Placebo or amoxicillin dispersible tablets']","['number of children with nonsevere fast-breathing pneumonia', 'failure rate', 'treatment failure or relapse', 'nonsevere fast-breathing pneumonia', 'proportion of children failing treatment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0001737', 'cui_str': 'Africa'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0162643'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",1126.0,0.681317,"There were no deaths.
","[{'ForeName': 'Amy Sarah', 'Initials': 'AS', 'LastName': 'Ginsburg', 'Affiliation': 'Save the Children Federation, Inc, Fairfield, Connecticut.'}, {'ForeName': 'Tisungane', 'Initials': 'T', 'LastName': 'Mvalo', 'Affiliation': 'University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre, Lilongwe, Malawi.'}, {'ForeName': 'Evangelyn', 'Initials': 'E', 'LastName': 'Nkwopara', 'Affiliation': 'Save the Children Federation, Inc, Fairfield, Connecticut.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'McCollum', 'Affiliation': 'Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Chifundo B', 'Initials': 'CB', 'LastName': 'Ndamala', 'Affiliation': 'University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre, Lilongwe, Malawi.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schmicker', 'Affiliation': 'Department of Biostatistics, University of Washington Clinical Trial Center, Seattle.'}, {'ForeName': 'Ajib', 'Initials': 'A', 'LastName': 'Phiri', 'Affiliation': 'Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Chichiri, Blantyre.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Lufesi', 'Affiliation': 'Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health, Lilongwe.'}, {'ForeName': 'Rasa', 'Initials': 'R', 'LastName': 'Izadnegahdar', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, Washington.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'May', 'Affiliation': 'Department of Biostatistics, University of Washington Clinical Trial Center, Seattle.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2018.3407']
436,31971595,Decrease in Resting Heart Rate Measured Using Smartphone Apps to Verify Abstinence From Smoking: An Exploratory Study.,"INTRODUCTION


Verifying self-reports of smoking abstinence is challenging in studies that involve remote data collection. Resting heart rate (HR) decreases during smoking abstinence. This study assessed whether a decrease in resting HR measured using freely available smartphone apps could potentially be used to verify smoking abstinence.
METHODS


This study involved a repeated measures experimental design, with data collection in natural setting. Participants were 18 adult, daily smokers. They recorded resting HR in beats per minute (bpm) using freely available smartphone apps during five timepoints (two in the morning and three postnoon) on each of 3 days. The outcome measure was the mean of the postnoon HR recordings. The experimental condition for each of the 3 days (counterbalanced order) was as follows: (1) smoking as usual, (2) not smoking without nicotine replacement therapy (NRT), or (3) not smoking but using NRT. Abstinence was verified using expired-air carbon monoxide (CO) concentration.
RESULTS


Compared with the smoking as usual condition, mean HR was 13.4 bpm lower (95% confidence interval [CI] = 5.4 to 21.4, p = .001) in the not smoking without NRT condition and 10.4 bpm lower (95% CI = 3.1 to 17.8, p = 0.004) in the not smoking with NRT condition. There was no statistically significant difference in HR between the two not smoking conditions (p = .39). Abstinence during not smoking days without and with NRT was CO-verified in 18/18 and in 16/18 cases, respectively.
CONCLUSIONS


Self-recording of resting HR in natural setting using smartphone apps shows a reliable decrease in response to smoking abstinence and may provide a basis for remote verification in smoking cessation studies.
IMPLICATIONS


Remote verification of self-reported abstinence in smoking cessation studies remains challenging. Smoking abstinence has been shown to decrease resting HR under laboratory conditions. This study demonstrated that self-recording using freely available smartphone apps shows reliable decreases in resting HR during smoking abstinence and may provide a basis for inexpensive remote verification of smoking abstinence.",2020,There was no statistically significant difference in HR between the two not smoking conditions (p=0.39).,"['Participants were 18 adult, daily smokers']","['smoking as usual, 2) not smoking without nicotine replacement therapy (NRT), or 3) not smoking but using NRT']","['HR', 'resting HR', 'expired-air carbon monoxide (CO) concentration', 'mean of the post-noon HR recordings', 'resting heart rate', 'Resting heart rate (HR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0585020', 'cui_str': 'Noon (qualifier value)'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate (observable entity)'}]",18.0,0.0368632,There was no statistically significant difference in HR between the two not smoking conditions (p=0.39).,"[{'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Herbec', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Parker', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Harveen Kaur', 'Initials': 'HK', 'LastName': 'Ubhi', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Raupach', 'Affiliation': 'The Centre for Behaviour Change, Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa021']
437,31962317,Differences in the Natural Enamel Surface and Acquired Enamel Pellicle following Exposure to Citric or Hydrochloric Acid.,"OBJECTIVES


The aim of this study was to investigate variations in the interaction between enamel, that is, the acquired enamel pellicle (AEP) and citric or hydrochloric acid.
MATERIALS AND METHODS


A 24-h AEP was formed on natural enamel specimens (n = 40) from pooled whole mouth human saliva. Samples were randomly allocated to citric (0.3%, pH 3.2) or hydrochloric (HCl) acid (0.01 M, pH 2.38) exposure for 30 or 300 s. The total protein concentration (TPC), and phosphorous and calcium concentrations of the pellicle were determined before and after acid exposure, and again after re-immersion in saliva. Surface roughness and tandem scanning confocal microscopy imaging were used to assess enamel changes.
RESULTS


After 300 s of citric acid exposure, the mean ± SD TPC reduced from 5.1 ± 1.1 to 3.5 ± 1.1 mg/mL (p < 0.05). In contrast, after 300 s of HCl exposure, the mean TPC did not reduce significantly from baseline (6.6 ± 1.1 to 5.7 ± 0.7 mg/mL) but was significantly reduced in the reformed pellicle to 4.9 ± 1.2 mg/mL (p < 0.001). This reduction occurred after significant release of calcium and phosphorous from the enamel surface (p < 0.001). Thirty seconds of exposure to either acid had no obvious effect on the AEP. The surface roughness of the enamel decreased after acid exposure but no differences between groups was observed.
CONCLUSIONS


These findings indicate that citric acid interacted with proteins in the AEP upon contact, offering enamel protection. In contrast, HCl appeared to bypass the pellicle, and reduced protein was observed only after changes in the enamel chemical composition.",2020,This reduction occurred after significant release of calcium and phosphorous from the enamel surface (p < 0.001).,[],"['Citric or Hydrochloric Acid', 'citric acid', 'hydrochloric (HCl) acid']","['AEP', 'mean TPC', 'mean ± SD TPC', 'total protein concentration (TPC), and phosphorous and calcium concentrations of the pellicle', 'surface roughness of the enamel']",[],"[{'cui': 'C0020259', 'cui_str': 'Hydrochloric Acid'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}]",,0.0300405,This reduction occurred after significant release of calcium and phosphorous from the enamel surface (p < 0.001).,"[{'ForeName': 'Jack William', 'Initials': 'JW', 'LastName': 'Houghton', 'Affiliation': ""Centre for Host Microbe-Interactions, King's College London Faculty of Dental, Oral and Craniofacial Sciences, London, United Kingdom, jack.houghton@kcl.ac.uk.""}, {'ForeName': 'Jing Teng', 'Initials': 'JT', 'LastName': 'Yong', 'Affiliation': ""Centre for Clinical, Oral and Translational Sciences, King's College London Faculty of Dental, Oral and Craniofacial Sciences, London, United Kingdom.""}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Carpenter', 'Affiliation': ""Centre for Host Microbe-Interactions, King's College London Faculty of Dental, Oral and Craniofacial Sciences, London, United Kingdom.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bartlett', 'Affiliation': ""Centre for Clinical, Oral and Translational Sciences, King's College London Faculty of Dental, Oral and Craniofacial Sciences, London, United Kingdom.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Moazzez', 'Affiliation': ""Centre for Clinical, Oral and Translational Sciences, King's College London Faculty of Dental, Oral and Craniofacial Sciences, London, United Kingdom.""}, {'ForeName': 'Saoirse', 'Initials': 'S', 'LastName': ""O'Toole"", 'Affiliation': ""Centre for Clinical, Oral and Translational Sciences, King's College London Faculty of Dental, Oral and Craniofacial Sciences, London, United Kingdom.""}]",Caries research,['10.1159/000504746']
438,31960624,"A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Subcutaneous Tezepelumab in Healthy Japanese Men.","Tezepelumab, a human immunoglobulin G2 monoclonal antibody against thymic stromal lymphopoietin, is currently under clinical development for the treatment of severe, uncontrolled asthma. This phase 1, randomized, placebo-controlled, single-ascending-dose study assessed the safety, tolerability, pharmacokinetics, and immunogenicity of subcutaneous tezepelumab in healthy Japanese men. Participants were assigned to 1 of 3 tezepelumab dose cohorts (35, 105, or 280 mg; n = 8 per cohort) and randomized (6:2) to receive a single subcutaneous dose of tezepelumab or placebo, with a follow-up period of 84 to 112 days. The overall incidences and severities of treatment-emergent adverse events were similar across tezepelumab doses and between the tezepelumab and placebo groups. Tezepelumab was absorbed slowly, reaching a maximum serum concentration (mean, 5.2-39.7 µg/mL) after 7 to 10 days. Area under the concentration-time curve (mean, 207.2-1612.0 µg · day /mL) increased in an approximate dose-proportional manner. Tezepelumab had a long terminal serum half-life (mean, 23.9-26.3 days) and a small apparent distribution volume, suggesting limited distribution into peripheral tissues. No participants developed anti-tezepelumab antibodies. Single-dose, subcutaneous administration of tezepelumab 35 to 280 mg resulted in an acceptable safety profile with linear pharmacokinetics in healthy Japanese men. No clear differences in tezepelumab safety and pharmacokinetics between Japanese and non-Japanese populations were identified.",2020,The overall incidences and severities of treatment-emergent adverse events were similar across tezepelumab doses and between the tezepelumab and placebo groups.,"['healthy Japanese men', 'Healthy Japanese Men']","['Placebo', 'Tezepelumab', 'tezepelumab', 'tezepelumab or placebo', 'placebo', 'Subcutaneous Tezepelumab', 'subcutaneous tezepelumab']","['overall incidences and severities of treatment-emergent adverse events', 'anti-tezepelumab antibodies', 'tezepelumab safety and pharmacokinetics', 'Safety, Tolerability, Pharmacokinetics, and Immunogenicity', 'maximum serum concentration', 'concentration-time curve', 'safety, tolerability, pharmacokinetics, and immunogenicity']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4550163', 'cui_str': 'tezepelumab'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4550163', 'cui_str': 'tezepelumab'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",,0.196404,The overall incidences and severities of treatment-emergent adverse events were similar across tezepelumab doses and between the tezepelumab and placebo groups.,"[{'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Sakamoto', 'Affiliation': 'AstraZeneca K.K., Ofuka-cho, Kita-ku, Osaka, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Matsuki', 'Affiliation': 'SOUSEIKAI Fukuoka Mirai Hospital Clinical Research Center, Fukuoka, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Irie', 'Affiliation': 'SOUSEIKAI Fukuoka Mirai Hospital Clinical Research Center, Fukuoka, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Uchida', 'Affiliation': 'Department of Pharmacology, Division of Clinical Pharmacology, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'AstraZeneca K.K., Ofuka-cho, Kita-ku, Osaka, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Horiuchi', 'Affiliation': 'AstraZeneca K.K., Ofuka-cho, Kita-ku, Osaka, Japan.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': 'Quantitative Clinical Pharmacology, AstraZeneca, Gaithersburg, Maryland, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.775']
439,31881241,Survival of composite restorations after selective or total caries removal in primary teeth and predictors of failures: A 36-months randomized controlled trial.,"OBJECTIVES


The aim of this study was to assess the survival of composite restorations after selective (SCR) or total caries removal (TCR) and determine predictors of failures after 36 months.
METHODS


120 teeth with deep occlusal or occlusal-proximal carious lesions were randomly divided into control (TCR; n = 54; 69% Class II) and test (SCR; n = 66; 63% Class II) groups. Clinical evaluation was applied using the USPHS criteria, and the presence of Charlie or Delta scores at the marginal integrity were considered as a failure.
RESULTS


The overall survival rate of restorations was 68% after 36 months, 81% for TCR and 57% for SCR (p = 0.004). The multivariable Cox Regression model demonstrated that restorations performed after SCR had 3.44 times greater probability of failure compared to TCR (p = 0.006). The other two predictors for failure of restorations were teeth with Class II cavities (hazard ratio = 3.3) and children with gingival bleeding over 20% (hazard ratio = 2.5).
CONCLUSIONS


Performing composite restorations after SCR in primary teeth had success rate significantly lower than restorations performed after TCR. Complex cavities and worst patient´s oral hygiene were found to be predictors of failure of restorations.
CLINICAL SIGNIFICANCE


Although SCR has been demonstrating high rates of pulp preservation, clinicians should consider that composite restorations fail in a higher frequency compared to TCR in primary teeth and, in some circumstances, may be preferable in terms of restoration longevity.",2020,"The overall survival rate of restorations was 68% after 36 months, 81% for TCR and 57% for SCR (p = 0.004).",['120 teeth with deep occlusal or occlusal-proximal carious lesions'],['selective (SCR) or total caries removal (TCR'],"['overall survival rate of restorations', 'probability of failure', 'survival of composite restorations', 'success rate', 'gingival bleeding']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0017565', 'cui_str': 'Gingival Hemorrhage'}]",120.0,0.0391794,"The overall survival rate of restorations was 68% after 36 months, 81% for TCR and 57% for SCR (p = 0.004).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Liberman', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, Universidad de la Republica, Montevideo, Uruguay.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Franzon', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil. Electronic address: renatafranzon@hotmail.com.'}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Guimarães', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Casagrande', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Haas', 'Affiliation': 'Periodontology, School of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'F B', 'Initials': 'FB', 'LastName': 'Araujo', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}]",Journal of dentistry,['10.1016/j.jdent.2019.103268']
440,30674451,"Three week versus six week immobilisation for stable Weber B type ankle fractures: randomised, multicentre, non-inferiority clinical trial.","OBJECTIVE


To determine whether treatment of isolated stable Weber B type ankle fractures with a cast or a simple orthotic device for three weeks produces non-inferior outcomes compared with conventional immobilisation in a cast for six weeks.
DESIGN


Randomised, pragmatic, non-inferiority, clinical trial with blinded outcome assessment.
SETTING


Two major trauma centres in Finland, 22 December 2012 to 6 June 2016.
PARTICIPANTS


247 skeletally mature patients aged 16 years or older with an isolated Weber B type fibula fracture and congruent ankle mortise in static ankle radiographs.
INTERVENTIONS


Participants were randomly allocated to conventional six week cast immobilisation (n=84) or three week treatment either in a cast (n=83) or in a simple orthosis (n=80).
MAIN OUTCOME MEASURES


The primary, non-inferiority, intention-to-treat outcome was the Olerud-Molander Ankle Score at 12 months (OMAS; range 0-100; higher scores indicate better outcomes and fewer symptoms). The predefined non-inferiority margin for the primary outcome was -8.8 points. Secondary outcomes were ankle function, pain, quality of life, ankle motion, and radiographic outcome. Follow-up assessments were performed at 6, 12, and 52 weeks.
RESULTS


212 of 247 randomised participants (86%) completed the study. At 52 weeks, the mean OMAS was 87.6 (SD 18.3) in the six week cast group, 91.7 (SD 12.9) in the three week cast group, and 89.8 (SD 18.4) in the three week orthosis group. The between group difference at 52 weeks for the three week cast versus six week cast was 3.6 points (95% confidence interval -1.9 to 9.1, P=0.20), and for the three week orthosis versus six week cast was 1.7 points (-4.0 to 7.3, P=0.56). In both comparisons, the confidence intervals did not include the predefined inferiority margin of -8.8 points. The only statistically significant between group differences observed in the secondary outcomes and harms in the two primary comparisons were slight improvement in ankle plantar flexion and incidence of deep vein thrombosis, both in the three week orthosis group versus six week cast group.
CONCLUSION


Immobilisation for three weeks with a cast or orthosis was non-inferior to conventional cast immobilisation for six weeks in the treatment of an isolated stable Weber B type fracture.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01758835.",2019,"The only statistically significant between group differences observed in the secondary outcomes and harms in the two primary comparisons were slight improvement in ankle plantar flexion and incidence of deep vein thrombosis, both in the three week orthosis group versus six week cast group.
","['212 of 247 randomised participants (86%) completed the study', '247 skeletally mature patients aged 16 years or older with an isolated Weber B type fibula fracture and congruent ankle mortise in static ankle radiographs', 'Two major trauma centres in Finland, 22 December 2012 to 6 June 2016']","['conventional six week cast immobilisation (n=84) or three week treatment either in a cast (n=83) or in a simple orthosis', 'conventional immobilisation']","['Olerud-Molander Ankle Score', 'ankle function, pain, quality of life, ankle motion, and radiographic outcome', 'ankle plantar flexion and incidence of deep vein thrombosis', 'mean OMAS']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0582525', 'cui_str': 'weber (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0149699', 'cui_str': 'Fracture of fibula (disorder)'}, {'cui': 'C0439853', 'cui_str': 'Congruent (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}]","[{'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion, function (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",247.0,0.251415,"The only statistically significant between group differences observed in the secondary outcomes and harms in the two primary comparisons were slight improvement in ankle plantar flexion and incidence of deep vein thrombosis, both in the three week orthosis group versus six week cast group.
","[{'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Kortekangas', 'Affiliation': 'Department of Surgery, Division of Orthopaedic and Trauma Surgery, Oulu University Hospital, Kajaanintie 50, PO Box 21, FI 90029 OYS, Oulu, Finland tero.kortekangas@ppshp.fi.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Haapasalo', 'Affiliation': 'Department of Orthopaedics, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Tapio', 'Initials': 'T', 'LastName': 'Flinkkilä', 'Affiliation': 'Department of Surgery, Division of Orthopaedic and Trauma Surgery, Oulu University Hospital, Kajaanintie 50, PO Box 21, FI 90029 OYS, Oulu, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Ohtonen', 'Affiliation': 'Medical Research Centre (MRC) Oulu, Oulu, Finland.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Nortunen', 'Affiliation': 'Department of Surgery, Division of Orthopaedic and Trauma Surgery, Oulu University Hospital, Kajaanintie 50, PO Box 21, FI 90029 OYS, Oulu, Finland.'}, {'ForeName': 'Heikki-Jussi', 'Initials': 'HJ', 'LastName': 'Laine', 'Affiliation': 'Department of Orthopaedics, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Teppo Ln', 'Initials': 'TL', 'LastName': 'Järvinen', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Orthopaedics, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Pakarinen', 'Affiliation': 'Department of Surgery, Division of Orthopaedic and Trauma Surgery, Oulu University Hospital, Kajaanintie 50, PO Box 21, FI 90029 OYS, Oulu, Finland.'}]",BMJ (Clinical research ed.),['10.1136/bmj.k5432']
441,30623420,Marine omega-3 fatty acid intake and survival of stage III colon cancer according to tumor molecular markers in NCCTG Phase III trial N0147 (Alliance).,"Marine omega-3 polyunsaturated fatty acids (MO3PUFAs) have anticancer properties and may improve colon cancer survival. However, it remains unknown whether the benefit differs by tumor molecular subtype. We examined data from a phase III randomized trial of FOLFOX or FOLFOX + cetuximab among 1,735 stage III colon cancer patients who completed a dietary questionnaire at enrollment. Multivariable hazard ratios and 95% confidence intervals (CIs) were calculated for the association between MO3PUFA and disease-free survival (DFS) and overall survival according to KRAS and BRAF V600E  mutations and DNA mismatch repair (MMR) status. Higher MO3PUFA intake was associated with improved 3-year DFS for KRAS wild-type tumors (77% vs. 73%; HR: 0.84; 95% CI: 0.67-1.05) but not KRAS-mutant tumors (64% vs. 70%; HR: 1.30; 95% CI: 0.97-1.73; P interaction  = 0.02). Similar heterogeneity was found by MMR (P interaction  = 0.14): higher MO3PUFA was associated with better 3-year DFS for tumors with deficient MMR (72% vs. 67%) but not proficient MMR (72% vs. 72%). No heterogeneity was found by BRAF V600E  mutation. Similar findings were obtained for overall survival. In conclusion, we found a suggestive beneficial association between higher MO3PUFA intake and improved survival among stage III colon cancer patients with wild-type KRAS and deficient MMR. Given the relatively small number of cases with tumor molecular assessments, further studies, preferably through pooled analyses of multiples cohorts, are needed to validate our findings.",2019,Similar heterogeneity was found by MMR (P interaction  = 0.14): higher MO3PUFA was associated with better 3-year DFS for tumors with deficient MMR (72% vs. 67%) but not proficient MMR (72% vs. 72%).,"['1,735 stage III colon cancer patients who completed a dietary questionnaire at enrollment', 'stage III colon cancer patients with wild-type KRAS and deficient MMR']","['Marine omega-3 polyunsaturated fatty acids (MO3PUFAs', 'Marine omega-3 fatty acid intake', 'FOLFOX or FOLFOX + cetuximab']","['colon cancer survival', 'survival', 'MO3PUFA and disease-free survival (DFS) and overall survival', '3-year DFS', 'overall survival']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}]","[{'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0556124', 'cui_str': 'N-3 fatty acid intake (observable entity)'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",,0.116466,Similar heterogeneity was found by MMR (P interaction  = 0.14): higher MO3PUFA was associated with better 3-year DFS for tumors with deficient MMR (72% vs. 67%) but not proficient MMR (72% vs. 72%).,"[{'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Department of Epidemiology and Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Tyler J', 'Initials': 'TJ', 'LastName': 'Zemla', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Hull', 'Affiliation': ""Leeds Institute of Biomedical & Clinical Sciences, University of Leeds, St. James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Limburg', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Alberts', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Sinicrope', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Giovannucci', 'Affiliation': 'Department of Epidemiology and Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Van Blarigan', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Partners Cancer Care and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Chan', 'Affiliation': 'Clinical and Translational Epidemiology Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}]",International journal of cancer,['10.1002/ijc.32113']
442,31927509,Reconciling mixed messages from mixed methods: A randomized trial of a professional development course to increase trauma-informed care.,"In a previously reported randomized trial, we used both quantitative and qualitative methods to assess the impact of a professional development course, Enhancing Trauma Awareness, to increase trauma-informed care among preschool teachers in a large, urban, US school district. Although quantitative data from surveys showed no impacts of the course, the qualitative data from focus groups suggested that the course had positive, meaningful impacts on the teachers. These contrasting results are reconciled here by describing our experience of conducting and analyzing the focus group data. We explain how the course impacted the teachers and the implications of these mechanisms for implementing and evaluating approaches to increasing trauma-informed care. The course combined content about the effects of trauma with a key ingredient-a group-based relational process carried out over 12 weeks by two trainers. Through their engaged presence, the trainers allowed the course participants to feel emotionally safe. This safety allowed the participants to develop awareness and acceptance of trauma in their own lives and those of others. Teachers described the course as healing. They developed relational capacities manifested in their own engaged presence, characterized as a compassionate approach to addressing trauma experienced by children and families.",2020,"Although quantitative data from surveys showed no impacts of the course, the qualitative data from focus groups suggested that the course had positive, meaningful impacts on the teachers.","['preschool teachers in a large, urban, US school district']",[],[],"[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],[],,0.0309909,"Although quantitative data from surveys showed no impacts of the course, the qualitative data from focus groups suggested that the course had positive, meaningful impacts on the teachers.","[{'ForeName': 'Allison N', 'Initials': 'AN', 'LastName': 'Herman', 'Affiliation': 'Columbia-Bassett Program, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, United States; Columbia-Bassett Program, Bassett Medical Center, Cooperstown, NY, United States; Bassett Research Institute, Bassett Medical Center, Cooperstown, NY, United States. Electronic address: allison.herman@bassett.org.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Whitaker', 'Affiliation': 'Columbia-Bassett Program, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, United States; Columbia-Bassett Program, Bassett Medical Center, Cooperstown, NY, United States; Bassett Research Institute, Bassett Medical Center, Cooperstown, NY, United States; Department of Pediatrics, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, United States.'}]",Child abuse & neglect,['10.1016/j.chiabu.2019.104349']
443,31574589,Effects of modifying visual inhaler spacer usage instructions on correct usage rate of untrained users.,"BACKGROUND


Pressurized metered-dose inhalers (pMDIs) used with spacers are considered the method of choice for delivery of inhaled drugs in preschool-age children. The aim of this study was to determine the effects of modifying the visual inhaler spacer usage guidelines on the correct usage rate.
METHODS


The parents and caregivers of patients <6 years old who were prescribed inhalers with spacers for the first time were included in our study. The participants were randomly divided into a modified visual inhaler spacer usage guidelines group and an unmodified visual inhaler spacer usage guidelines group. All study participants underwent face-to-face interviews and completed questionnaires.
RESULTS


A total of 510 participants with a median age of 31 (range, 20-46) years were included in this study. The modified visual guidelines group included 254 (49.6%) participants, and the unmodified visual guidelines group included 256 (50.4%) participants. One hundred sixty-five (65.2%) of the 254 participants in the modified visual guidelines group correctly demonstrated the inhaler spacer technique. In contrast, only 21 (8.2%) of the 256 participants in the unmodified visual guidelines group correctly demonstrated the inhaler spacer technique (p < 0.001). When comparing the inhaler spacer usage steps between the 2 groups, the modified visual guidelines group demonstrated the steps more correctly and more quickly (p < 0.001).
CONCLUSION


The current visual inhaler spacer usage guidelines are insufficient. We believe that improving the visual inhaler spacer usage guidelines, in particular, will increase the correct usage rate and decrease the number of usage errors.",2020,"When comparing the inhaler spacer usage steps between the 2 groups, the modified visual guidelines group demonstrated the steps more correctly and more quickly (p < 0.001).
","['preschool-age children', 'untrained users', 'parents and caregivers of patients <6 years old who were prescribed inhalers with spacers for the first time were included in our study', '510 participants with a median age of 31 (range, 20-46) years', 'One hundred sixty-five (65.2%) of the 254 participants', 'group included 254 (49.6%) participants, and the unmodified visual guidelines group included 256 (50.4%) participants']","['modifying visual inhaler spacer usage instructions', 'modified visual inhaler spacer usage guidelines group and an unmodified visual inhaler spacer usage guidelines group', 'modified visual guidelines']",['inhaler spacer technique'],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0221874', 'cui_str': 'Spacer (physical object)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517800', 'cui_str': '510 (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0221874', 'cui_str': 'Spacer (physical object)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0221874', 'cui_str': 'Spacer (physical object)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]",510.0,0.0315846,"When comparing the inhaler spacer usage steps between the 2 groups, the modified visual guidelines group demonstrated the steps more correctly and more quickly (p < 0.001).
","[{'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Topal', 'Affiliation': 'Pediatric Allergy and Immunology Department, Faculty of Medicine, Inonu University, Malatya, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Arga', 'Affiliation': 'Pediatric Allergy and Immunology Department, Faculty of Medicine, İstanbul Medeniyet University, İstanbul, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Özmen', 'Affiliation': 'Department of Pediatrics, Bakırköy Sadi Konuk Education and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Doğru', 'Affiliation': 'Pediatric Allergy and Immunology Department, Zeynep Kamil Education and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'Alataş', 'Affiliation': 'Pediatric Allergy and Immunology Department, Faculty of Medicine, Inonu University, Malatya, Turkey.'}, {'ForeName': 'Elif Büşra', 'Initials': 'EB', 'LastName': 'Muştu', 'Affiliation': 'Pediatric Allergy and Immunology Department, Faculty of Medicine, İstanbul Medeniyet University, İstanbul, Turkey.'}, {'ForeName': 'Mehmet Halil', 'Initials': 'MH', 'LastName': 'Çeliksoy', 'Affiliation': 'Pediatric Allergy and Immunology Department, GOP Taksim Education and Research Hospital, İstanbul, Turkey.'}]",International forum of allergy & rhinology,['10.1002/alr.22440']
444,31981832,Active video games for knee osteoarthritis improve mobility but not WOMAC score: A randomized controlled trial.,"BACKGROUND


Active video games (AVGs) have become popular and have been investigated for their therapeutic purposes. However, the effect of AVGs on patients with knee osteoarthritis (OA) remains uncertain.
OBJECTIVE


We aimed to compare the effects of AVGs with those of traditional therapeutic exercise on patients with knee OA.
METHOD


This was a prospective single-blind, randomized controlled trial. Participants (n=80) with knee OA were allocated to the AVGs group (n=40) or therapeutic exercise group (n=40). Both groups received treatment 3 times a week for 4 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and secondary outcome measures were the World Health Organization Quality of Life-Brief Vision, Hospital Anxiety and Depression Scale, Multidimensional Fatigue Inventory, physical functional performance (including time for 10-m walking and for ascending and descending stairs), Biodex Stability System, Chronic Pain Grade Questionnaire, and Work Ability Index. The patients were evaluated at baseline, 2 and 4 weeks after treatment, and 1 and 3 months after treatment completion.
RESULTS


Both groups showed significant time effect in the pain subcategory of the WOMAC (P=0.047). However, we found no significant group×time interaction effect between the groups at any follow-up assessments for pain (P=0.066), stiffness (P=0.284), or physical function (P=0.179) for the WOMAC. Among the secondary outcomes, we found significant group×time effects favoring the AVG group in dynamic balance (P=0.020), and physical functional performance including 10-m walking time (P=0.002) and stair ascent time (P=0.005), and the physical domain of health (P=0.032).
CONCLUSIONS


Therapeutic exercises and playing AVGs similarly improved the pain of patients with knee OA; however, playing AVGs improved dynamic balance, physical functional performance, and physical health more than therapeutic exercises did.",2020,Both groups showed significant time effect in the pain subcategory of the WOMAC (p = 0.047).,"['patients with knee OA', 'patients with knee osteoarthritis (OA', 'Participants (n = 80) with knee OA']","['Active video games', 'traditional therapeutic exercise', 'therapeutic exercise']","['physical domain of health', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and secondary outcome measures were the World Health Organization Quality of Life-Brief Vision, Hospital Anxiety and Depression Scale, Multidimensional Fatigue Inventory, physical functional performance (including time for 10-m walking and for ascending and descending stairs), Biodex Stability System, Chronic Pain Grade Questionnaire, and Work Ability Index', 'dynamic balance', 'pain subcategory of the WOMAC', 'physical function', 'physical functional performance including 10-m walking time', 'time interaction effect', 'dynamic balance, physical functional performance, and physical health', 'WOMAC score', 'stair ascent time', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0034380'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4704690', 'cui_str': 'Physical Functional Performance'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0205386', 'cui_str': 'Descending (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",80.0,0.0681344,Both groups showed significant time effect in the pain subcategory of the WOMAC (p = 0.047).,"[{'ForeName': 'Yu-Ting', 'Initials': 'YT', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wen-Chung', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': 'Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Ru-Lan', 'Initials': 'RL', 'LastName': 'Hsieh', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan; Department of Physical Medicine and Rehabilitation, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. Electronic address: M001052@ms.skh.org.tw.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2019.11.008']
445,31943168,Nab-paclitaxel in older patients with non-small cell lung cancer who have developed disease progression after platinum-based doublet chemotherapy.,"BACKGROUND


The selection of later-line treatment for older patients with AJCC (version 7) stage IV non-small cell lung cancer (NSCLC) remains controversial. Nanoparticle albumin-bound (nab)-paclitaxel is approved with carboplatin for the first-line treatment of patients with NSCLC and subgroup analysis of phase 3 data has suggested superior survival in older patients.
METHODS


The authors conducted a phase 2 study of nab-paclitaxel in 42 patients aged ≥70 years who had been treated previously with a platinum doublet regimen; patients also could have received a PD-1 inhibitor. The primary endpoint of the current study was grade 3 to 5 toxicity (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]). In addition to response rate, progression-free survival (PFS), and overall survival (OS), geriatric assessments also were performed before and during treatment, associations between baseline sarcopenia and outcomes were explored, and changes in T lymphocyte p16 before and during treatment were measured. The authors also performed a retrospective subgroup analysis of 19 older patients who were treated with nab-paclitaxel as part of a larger, randomized, phase 2 study; data were not combined.
RESULTS


The rate of grade 3 to 5 toxicities was 33.7%. The most common grade 3 to 5 toxicities were decreased white blood cell count (11.9%), neutropenia (9.5%), and fatigue (11.9%). The response rate was 34.2% (2.6% complete response rate and 31.6% partial response rate). The median PFS was 5.2 months and the median OS was 9.3 months. Adverse prognostic factors were common: 42% of patients were frail and 39% of patients were prefrail, whereas 21% had an Eastern Cooperative Oncology Group performance status of 2 and 27% were sarcopenic. Only frailty was found to be predictive of inferior survival. A subgroup analysis of 19 older patients treated with nab-paclitaxel alone in a prior trial demonstrated a response rate of 15.8%, a PFS of 4.2 months, and an OS of 13.6 months.
CONCLUSIONS


Fit and prefrail older patients with stage IV NSCLC should be considered for treatment with nab-paclitaxel after disease progression with doublet chemotherapy.",2020,The response rate was 34.2% (2.6% complete response rate and 31.6% partial response rate).,"['19 older patients who were treated with nab-paclitaxel as part of a larger, randomized, phase 2 study; data were not combined', '19 older patients treated with', 'older patients with AJCC (version 7) stage IV non-small cell lung cancer (NSCLC', 'older patients with non-small cell lung cancer who have developed disease progression after platinum-based doublet chemotherapy', 'prefrail older patients with stage IV NSCLC', '42 patients aged ≥70\xa0years who had been treated previously with a platinum doublet regimen; patients also could have received a']","['Nanoparticle albumin-bound (nab)-paclitaxel', 'nab-paclitaxel alone', 'Nab-paclitaxel', 'nab-paclitaxel', 'PD-1 inhibitor']","['neutropenia', 'Adverse prognostic factors', 'median PFS', 'rate of grade 3 to 5 toxicities', 'median OS', 'response rate', 'response rate, progression-free survival (PFS), and overall survival (OS), geriatric assessments', 'fatigue', 'white blood cell count', 'grade 3 to 5 toxicity']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C1961039', 'cui_str': 'paclitaxel protein-bound'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0017463', 'cui_str': 'Geriatric Assessment'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}]",,0.104919,The response rate was 34.2% (2.6% complete response rate and 31.6% partial response rate).,"[{'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Weiss', 'Affiliation': 'Department of Hematology and Oncology, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Pennell', 'Affiliation': 'Hematology and Medical Oncology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'Department of Hematology and Oncology, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Morgensztern', 'Affiliation': 'Oncology Division, Department of Medicine, Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Bradford', 'Affiliation': 'Highlands Oncology, Fayetteville, Arkansas.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Crane', 'Affiliation': 'Rex Hematology Oncology Associates, Raleigh-Durham, North Carolina.'}, {'ForeName': 'Howard Jack', 'Initials': 'HJ', 'LastName': 'West', 'Affiliation': 'Department of Medical Oncology, Swedish Cancer Institute, Seattle, Washington.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Department of Hematology and Oncology, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Pecot', 'Affiliation': 'Department of Hematology and Oncology, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Stevenson', 'Affiliation': 'Hematology and Medical Oncology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Irvin', 'Affiliation': 'Medical Oncology, Bon Secours, Midlothian, Virginia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Socinski', 'Affiliation': 'Florida Hospital Cancer Institute, Orlando, Florida.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Stinchcombe', 'Affiliation': 'Division of Medical Oncology, Duke Cancer Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Liza C', 'Initials': 'LC', 'LastName': 'Villaruz', 'Affiliation': 'Division of Hematology/Oncology, University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Hyman B', 'Initials': 'HB', 'LastName': 'Muss', 'Affiliation': 'Department of Hematology and Oncology, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}]",Cancer,['10.1002/cncr.32573']
446,28259857,Auditory training changes temporal lobe connectivity in 'Wernicke's aphasia': a randomised trial.,"INTRODUCTION


Aphasia is one of the most disabling sequelae after stroke, occurring in 25%-40% of stroke survivors. However, there remains a lack of good evidence for the efficacy or mechanisms of speech comprehension rehabilitation.
TRIAL DESIGN


This within-subjects trial tested two concurrent interventions in 20 patients with chronic aphasia with speech comprehension impairment following left hemisphere stroke: (1) phonological training using 'Earobics' software and (2) a pharmacological intervention using donepezil, an acetylcholinesterase inhibitor. Donepezil was tested in a double-blind, placebo-controlled, cross-over design using block randomisation with bias minimisation.
METHODS


The primary outcome measure was speech comprehension score on the comprehensive aphasia test. Magnetoencephalography (MEG) with an established index of auditory perception, the mismatch negativity response, tested whether the therapies altered effective connectivity at the lower (primary) or higher (secondary) level of the auditory network.
RESULTS


Phonological training improved speech comprehension abilities and was particularly effective for patients with severe deficits. No major adverse effects of donepezil were observed, but it had an unpredicted negative effect on speech comprehension. The MEG analysis demonstrated that phonological training increased synaptic gain in the left superior temporal gyrus (STG). Patients with more severe speech comprehension impairments also showed strengthening of bidirectional connections between the left and right STG.
CONCLUSIONS


Phonological training resulted in a small but significant improvement in speech comprehension, whereas donepezil had a negative effect. The connectivity results indicated that training reshaped higher order phonological representations in the left STG and (in more severe patients) induced stronger interhemispheric transfer of information between higher levels of auditory cortex.Clinical trial registrationThis trial was registered with EudraCT (2005-004215-30, https:// eudract .ema.europa.eu/) and ISRCTN (68939136, http://www.isrctn.com/).",2017,The MEG analysis demonstrated that phonological training increased synaptic gain in the left superior temporal gyrus (STG).,"['2005-004215-30, https:// eudract .ema.europa.eu/) and ISRCTN (68939136, http://www.isrctn.com', '20 patients with chronic aphasia with speech comprehension impairment following left hemisphere stroke: (1', ""Wernicke's aphasia"", 'patients with severe deficits', 'Patients with more severe speech comprehension impairments']","['donepezil', 'placebo', ""phonological training using 'Earobics' software and (2) a pharmacological intervention using donepezil, an acetylcholinesterase inhibitor"", 'EudraCT', 'Auditory training', 'Magnetoencephalography (MEG', 'Donepezil', 'Phonological training', 'phonological training']","['speech comprehension score on the comprehensive aphasia test', 'speech comprehension abilities', 'speech comprehension', 'phonological representations', 'synaptic gain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1510456', 'cui_str': 'Wernicke Aphasia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C4521949', 'cui_str': 'Acetylcholinesterase inhibitor (disposition)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4505400', 'cui_str': 'Comprehensive Aphasia Test'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",20.0,0.344999,The MEG analysis demonstrated that phonological training increased synaptic gain in the left superior temporal gyrus (STG).,"[{'ForeName': 'Zoe Vj', 'Initials': 'ZV', 'LastName': 'Woodhead', 'Affiliation': 'Department of Brain Repair and Rehabilitation, University College London, London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Crinion', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK.'}, {'ForeName': 'Sundeep', 'Initials': 'S', 'LastName': 'Teki', 'Affiliation': 'Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Penny', 'Affiliation': 'Wellcome Trust Centre for Neuroimaging, University College London, London, UK.'}, {'ForeName': 'Cathy J', 'Initials': 'CJ', 'LastName': 'Price', 'Affiliation': 'Wellcome Trust Centre for Neuroimaging, University College London, London, UK.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Leff', 'Affiliation': 'Wellcome Trust Centre for Neuroimaging, University College London, London, UK.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2016-314621']
447,31977632,Nonexercise Equations for Determining Change in Cardiorespiratory Fitness.,"PURPOSE


This study aimed to determine whether change in estimated cardiorespiratory fitness (eCRF) is associated with change in measured cardiorespiratory fitness (mCRF) independent of exercise amount and intensity over 24 wk.
METHODS


Participants were 163 sedentary adults with abdominal obesity (mean ± SD waist circumference, 109.9 ± 11.5 cm) randomly assigned to (i) no-exercise control (n = 42); (ii) low-amount, low-intensity exercise (LALI; n = 39); (iii) high-amount, low-intensity exercise (HALI; n = 51); and (iv) high-amount, high-intensity exercise (HAHI; n = 31). mCRF was measured using a maximal treadmill test at baseline, 8, 16, and 24 wk. eCRF was calculated using a published nonexercise equation with the following variables: sex, age, waist circumference, resting heart rate, and self-selected physical activity.
RESULTS


Participants attended 115 of 120 exercise sessions prescribed (96.0% ± 4.0% adherence). eCRF change from baseline to 8, 16, and 24 wk was not different from mCRF change for control, LALI, or HALI (P = 0.03). In HAHI, eCRF change was significantly greater than mCRF change at all time points (P < 0.001). Further analysis revealed that change in eCRF systematically overestimated and underestimated small and large changes in mCRF, respectively, in all groups (P < 0.001).
CONCLUSIONS


eCRF change was associated with mCRF change at 24 wk independent of exercise amount but not intensity. Systematic variation between eCRF and mCRF highlights a possible limitation when using eCRF to follow change in mCRF, specifically that eCRF does not capture the individual variability of the mCRF response.",2020,"eCRF change from baseline to 8, 16 and 24 weeks was not different from mCRF change for control, LALI or HALI (P=.03).",['Participants were 163 sedentary adults with abdominal obesity (waist circumference: mean 109.9(SD'],"['i) no-exercise control (n=42), ii) low-amount, low-intensity exercise (LALI; n=39), iii) high-amount, low-intensity exercise (HALI; n=51), iv) high-amount, high-intensity exercise']","['eCRF', 'mCRF', 'mCRF change', 'eCRF change']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0311277', 'cui_str': 'Central Obesity'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",163.0,0.0607952,"eCRF change from baseline to 8, 16 and 24 weeks was not different from mCRF change for control, LALI or HALI (P=.03).","[{'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'DE Lannoy', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, CANADA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ross', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, CANADA.""}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002284']
448,31977634,Timing of Vaccination after Training: Immune Response and Side Effects in Athletes.,"OBJECTIVES


Influenza vaccination was used to assess whether induction of immunity or side effects are influenced by the timing of the last training session before vaccination.
METHODS


Forty-five healthy athletes (36 male, 23 ± 8 yr, ≥5 training sessions per week, predominantly national competition level) were vaccinated with the tetravalent influenza vaccine; blood samples were collected immediately before and 1, 2, and 26 wk after vaccination. Athletes were randomly assigned to vaccination within 2 h after the last training session versus after 24-26 h. Influenza-specific T cells were quantified after stimulation with the vaccine based on intracellular cytokine staining. Antibodies (IgA, IgG, IgM) were quantified by enzyme-linked immunosorbent assay and neutralization assay. Participants documented resulting side effects and training restrictions using a standardized diary.
RESULTS


Both groups showed an increase in influenza-reactive CD4 T-cell levels, which peaked 1 wk after vaccination (fold changes to baseline; median (interquartile range), 3.7 (3.0-5.4; P < 0.001) in the 2-h group; 4.6 (2.8-7.4; P < 0.001) in the 26-h group) with no difference between groups (P = 0.52). Influenza-specific antibodies showed a significant increase after vaccination in both groups (at least 1.4-fold, each P < 0.001, no group differences; P = 0.24-0.97 for different antibody types). Only antibodies toward the Brisbane strain showed a trend toward significant differences in neutralization titers between groups (4-fold (2-17.8) in the 2-h group, 16-fold (4-32.9) in the 26-h group; P = 0.06), whereas other specificities did not differ (P = 0.16-0.72). No intergroup differences were found for side effects; no athlete reported a loss of training time due to the vaccination or its side effects.
CONCLUSION


Infection prophylaxis in elite athletes by influenza vaccination seems to be effective and safe. Timing of vaccination after prior training does not seem to require specific constraints.",2020,"No inter-group differences were found for side effects; no athlete reported a loss of training time due to the vaccination or its side effects.
","['45 healthy athletes (36 males, 23±8 years, ≥ 5 training sessions per week, predominantly national competition level', 'elite athletes', 'Athletes']",[],"['neutralisation titers', 'influenza-reactive CD4 T-cell levels', 'loss of training time due to the vaccination or its side effects', 'side effects', 'Antibodies (IgA, IgG, IgM']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",[],"[{'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020861', 'cui_str': 'IgM'}]",45.0,0.0411972,"No inter-group differences were found for side effects; no athlete reported a loss of training time due to the vaccination or its side effects.
","[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Stenger', 'Affiliation': 'Institute of Sports and Preventive Medicine, Saarland University, Saarbrücken, GERMANY.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Ledo', 'Affiliation': 'Department of Transplant and Infection Immunology, Saarland University, Homburg/Saar, GERMANY.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Ziller', 'Affiliation': 'Institute of Sports and Preventive Medicine, Saarland University, Saarbrücken, GERMANY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schub', 'Affiliation': 'Department of Transplant and Infection Immunology, Saarland University, Homburg/Saar, GERMANY.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Schmidt', 'Affiliation': 'Department of Transplant and Infection Immunology, Saarland University, Homburg/Saar, GERMANY.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Enders', 'Affiliation': 'Laboratory Prof. G. Enders and Partners and Institute of Virology, Infectious Diseases and Epidemiology e.V., Stuttgart, GERMANY.'}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'GÄrtner', 'Affiliation': 'Institute of Medical Microbiology and Hygiene, Saarland University, Homburg/Saar, GERMANY.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Sester', 'Affiliation': 'Department of Transplant and Infection Immunology, Saarland University, Homburg/Saar, GERMANY.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Institute of Sports and Preventive Medicine, Saarland University, Saarbrücken, GERMANY.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002278']
449,31977638,Exercise Improves Video Game Performance: A Win-Win Situation.,"PURPOSE


Video gamers exceeding screen-time limits are at greater risk of experiencing health issues associated with physical inactivity. Demonstrating that exercise has positive effects on video game performance could promote physical activity among video gamers. We investigated the short-term effects of a single session of cardiovascular exercise on the performance of the popular video game League of Legends (LoL) and explored psychosocial mechanisms.
METHODS


Twenty young video gamers played a customized LoL task preceded by a short bout of high-intensity interval training or a period of rest. The two conditions were administered on two separate days in a randomized counterbalanced fashion. Video game performance was assessed as the total number of targets eliminated as well as accuracy, defined as the ability to eliminate targets using single attacks. Short-term changes in affect after exercise as well as exercise enjoyment were also assessed.
RESULTS


Exercise improved (P = 0.027) the capacity to eliminate targets (mean ± SEM, 121.17 ± 3.78) compared with rest (111.38 ± 3.43). Exercise also enhanced accuracy (P = 0.019), with fewer targets eliminated with more than one attack after exercise (1.39 ± 0.39) compared with rest (2.44 ± 0.51). Exercise increased positive affect by 17% (P = 0.007), but neither affect nor exercise enjoyment was associated with total number of targets eliminated or accuracy.
CONCLUSION


A short bout of intense cardiovascular exercise before playing LoL improves video game performance. More studies are needed to establish whether these effects are generalizable to other video games, whether repeated bouts have summative effects, and to identify underlying mechanisms.",2020,"Exercise increased positive affect by 17% (p=0.007) but neither affect nor exercise enjoyment were associated with total number of targets eliminated or accuracy.
",['Twenty young video gamers played a'],"['cardiovascular exercise', 'customized LoL task preceded by a short bout of high-intensity interval training or a period of rest']","['total number of targets eliminated or accuracy', 'exercise enjoyment', 'video game performance', 'Video game performance', 'Exercise Improves Video Game Performance']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",20.0,0.0927857,"Exercise increased positive affect by 17% (p=0.007) but neither affect nor exercise enjoyment were associated with total number of targets eliminated or accuracy.
","[{'ForeName': 'Bernat', 'Initials': 'B', 'LastName': 'DE Las Heras', 'Affiliation': 'Memory and Motor Rehabilitation Laboratory (MEMORY-LAB), Feil and Oberfeld Research Centre, Jewish Rehabilitation Hospital, Montreal Center for Interdisciplinary Research in Rehabilitation (CRIR), Laval, Quebec, CANADA.'}, {'ForeName': 'Orville', 'Initials': 'O', 'LastName': 'Li', 'Affiliation': 'Memory and Motor Rehabilitation Laboratory (MEMORY-LAB), Feil and Oberfeld Research Centre, Jewish Rehabilitation Hospital, Montreal Center for Interdisciplinary Research in Rehabilitation (CRIR), Laval, Quebec, CANADA.'}, {'ForeName': 'Lynden', 'Initials': 'L', 'LastName': 'Rodrigues', 'Affiliation': 'Memory and Motor Rehabilitation Laboratory (MEMORY-LAB), Feil and Oberfeld Research Centre, Jewish Rehabilitation Hospital, Montreal Center for Interdisciplinary Research in Rehabilitation (CRIR), Laval, Quebec, CANADA.'}, {'ForeName': 'Jean-FranÇois', 'Initials': 'JF', 'LastName': 'Nepveu', 'Affiliation': 'Memory and Motor Rehabilitation Laboratory (MEMORY-LAB), Feil and Oberfeld Research Centre, Jewish Rehabilitation Hospital, Montreal Center for Interdisciplinary Research in Rehabilitation (CRIR), Laval, Quebec, CANADA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Roig', 'Affiliation': 'Memory and Motor Rehabilitation Laboratory (MEMORY-LAB), Feil and Oberfeld Research Centre, Jewish Rehabilitation Hospital, Montreal Center for Interdisciplinary Research in Rehabilitation (CRIR), Laval, Quebec, CANADA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002277']
450,31960188,Emotionally salient patient information enhances the educational value of surgical videos.,"Medical students' motivations for choosing a medical career are likely based on and remain tethered to the affectively-laden caring component of doctor-patient interactions. However, this component is rarely presented in educational surgical videos. It is unknown whether affectively engaging students by including patient-related emotionally salient information potentiates or draws focus away from learning a surgical procedure and whether such information affects motivation and attitudes toward the video. Therefore, we investigate whether presenting a patient's emotional state before video surgery enhances or weakens the educational value of that video. In a within-subjects crossover design, second-year medical students (n = 130) viewed video clips of surgeries. These videos, from online medical education platforms, were preceded by the patient's information from the original video or by information about the patient's preoperative emotional preparation. After each video, participants completed a multiple-choice test about the video's content to measure learning, answered a question about their motivation to re-watch the video, and completed an attitude scale regarding the video. Incorporating patient's information into surgical videos significantly enhanced students' acquisition of the technical aspects of surgery procedures (p < 0.0001), motivation to re-watch the video (p < 0.001), and favorable attitudes toward the video (p = 0.02). These findings show that incorporating information about patients' emotional states may enhance students' positive attitudes and motivations toward educational videos and may improve their learning of surgical techniques. They also suggest that the role of this factor should be considered when developing guidelines for medical educational video release.",2020,"Incorporating patient's information into surgical videos significantly enhanced students' acquisition of the technical aspects of surgery procedures (p < 0.0001), motivation to re-watch the video (p < 0.001), and favorable attitudes toward the video (p = 0.02).",[],['video clips of surgeries'],['motivation to re-watch the video'],[],"[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]",130.0,0.0295905,"Incorporating patient's information into surgical videos significantly enhanced students' acquisition of the technical aspects of surgery procedures (p < 0.0001), motivation to re-watch the video (p < 0.001), and favorable attitudes toward the video (p = 0.02).","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Colonnello', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40127, Bologna, Italy. valentina.colonnello@unibo.it.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Mattarozzi', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40127, Bologna, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Agostini', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40127, Bologna, Italy.'}, {'ForeName': 'Paolo Maria', 'Initials': 'PM', 'LastName': 'Russo', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40127, Bologna, Italy.'}]",Advances in health sciences education : theory and practice,['10.1007/s10459-020-09957-y']
451,31968063,Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial.,"Importance


Research supports use of prehabilitation to optimize physical status before and after colorectal cancer resection, but its effect on postoperative complications remains unclear. Frail patients are a target for prehabilitation interventions owing to increased risk for poor postoperative outcomes.
Objective


To assess the extent to which a prehabilitation program affects 30-day postoperative complications in frail patients undergoing colorectal cancer resection compared with postoperative rehabilitation.
Design, Setting, and Participants


This single-blind, parallel-arm, superiority randomized clinical trial recruited patients undergoing colorectal cancer resection from September 7, 2015, through June 19, 2019. Patients were followed up for 4 weeks before surgery and 4 weeks after surgery at 2 university-affiliated tertiary hospitals. A total of 418 patients 65 years or older were assessed for eligibility. Of these, 298 patients were excluded (not frail [n = 290], unable to exercise [n = 3], and planned neoadjuvant treatment [n = 5]), and 120 frail patients (Fried Frailty Index,≥2) were randomized. Ten patients were excluded after randomization because they refused surgery (n = 3), died before surgery (n = 3), had no cancer (n = 1), had surgery without bowel resection (n = 1), or were switched to palliative care (n = 2). Hence, 110 patients were included in the intention-to-treat analysis (55 in the prehabilitation [Prehab] and 55 in the rehabilitation [Rehab] groups). Data were analyzed from July 25 through August 21, 2019.
Interventions


Multimodal program involving exercise, nutritional, and psychological interventions initiated before (Prehab group) or after (Rehab group) surgery. All patients were treated within a standardized enhanced recovery pathway.
Main Outcomes and Measures


The primary outcome included the Comprehensive Complications Index measured at 30 days after surgery. Secondary outcomes were 30-day overall and severe complications, primary and total length of hospital stay, 30-day emergency department visits and hospital readmissions, recovery of walking capacity, and patient-reported outcome measures.
Results


Of 110 patients randomized, mean (SD) age was 78 (7) years; 52 (47.3%) were men and 58 (52.7%) were women; 31 (28.2%) had rectal cancer; and 87 (79.1%) underwent minimally invasive surgery. There was no between-group difference in the primary outcome measure, 30-day Comprehensive Complications Index (adjusted mean difference, -3.2; 95% CI, -11.8 to 5.3; P = .45). Secondary outcome measures were also not different between groups.
Conclusions and Relevance


In frail patients undergoing colorectal cancer resection (predominantly minimally invasive) within an enhanced recovery pathway, a multimodal prehabilitation program did not affect postoperative outcomes. Alternative strategies should be considered to optimize treatment of frail patients preoperatively.
Trial Registration


ClinicalTrials.gov identifier: NCT02502760.",2020,"There was no between-group difference in the primary outcome measure, 30-day Comprehensive Complications Index (adjusted mean difference,","['Frail Patients Undergoing Resection of Colorectal Cancer', '298 patients were excluded (not frail [n\u2009=\u2009290], unable to exercise [n\u2009=\u20093], and planned neoadjuvant treatment [n\u2009=\u20095]), and 120 frail patients (Fried Frailty Index,≥2', '110 patients were included in the intention-to-treat analysis (55 in the prehabilitation [Prehab] and 55 in the rehabilitation [Rehab] groups', 'patients undergoing colorectal cancer resection from September 7, 2015, through June 19, 2019', 'frail patients undergoing colorectal cancer resection (predominantly minimally invasive', '418 patients 65 years or older were assessed for eligibility', 'Ten patients were excluded after randomization because they refused surgery (n\u2009=\u20093), died before surgery (n\u2009=\u20093), had no cancer (n\u2009=\u20091), had surgery without bowel resection (n\u2009=\u20091), or were switched to palliative care (n\u2009=\u20092', 'frail patients preoperatively', 'frail patients undergoing colorectal cancer resection compared with postoperative rehabilitation', '110 patients randomized', ' mean (SD) age was 78 (7) years; 52 (47.3%) were men and 58 (52.7%) were women; 31 (28.2%) had rectal cancer; and 87 (79.1%) underwent minimally invasive surgery', 'Frail patients']","['prehabilitation program', 'Multimodal program involving exercise, nutritional, and psychological interventions initiated before (Prehab group) or after (Rehab group) surgery', 'Multimodal Prehabilitation vs Postoperative Rehabilitation']","['30-day Comprehensive Complications Index', '30-day overall and severe complications, primary and total length of hospital stay, 30-day emergency department visits and hospital readmissions, recovery of walking capacity, and patient-reported outcome measures', '30-Day Postoperative Complications', 'Comprehensive Complications Index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0741614', 'cui_str': 'Bowel resection'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0282624', 'cui_str': 'Minimal Surgical Procedures'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",110.0,0.282382,"There was no between-group difference in the primary outcome measure, 30-day Comprehensive Complications Index (adjusted mean difference,","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': 'Department of Anesthesia, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bousquet-Dion', 'Affiliation': 'Department of Anesthesia, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Rashami', 'Initials': 'R', 'LastName': 'Awasthi', 'Affiliation': 'Department of Anesthesia, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Elsherbini', 'Affiliation': 'Currently a medical student at Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Sender', 'Initials': 'S', 'LastName': 'Liberman', 'Affiliation': 'Department of Surgery, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Marylise', 'Initials': 'M', 'LastName': 'Boutros', 'Affiliation': 'Department of Surgery, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Stein', 'Affiliation': 'Department of Surgery, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Charlebois', 'Affiliation': 'Department of Surgery, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Ghitulescu', 'Affiliation': 'Department of Surgery, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Morin', 'Affiliation': 'Department of Surgery, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jagoe', 'Affiliation': 'Department of Medicine, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Celena', 'Initials': 'C', 'LastName': 'Scheede-Bergdahl', 'Affiliation': 'Department of Anesthesia, McGill Research Centre for Physical Activity and Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Enrico Maria', 'Initials': 'EM', 'LastName': 'Minnella', 'Affiliation': 'Department of Anesthesia, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Julio F', 'Initials': 'JF', 'LastName': 'Fiore', 'Affiliation': 'Department of Surgery, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}]",JAMA surgery,['10.1001/jamasurg.2019.5474']
452,31953028,The effect of modifiable lifestyle factors on semen quality.,"INTRODUCTION AND OBJECTIVES


To examine the association between lifestyle factors (body mass index, smoking, alcohol consumption, coffee intake, physical activity, sauna and cell phone usage, wearing tight-fitting underwear), and conventional semen parameters.
MATERIALS AND METHODS


1311 participants who attended the Andrology Clinic were included in the study. All participants were separated into two groups as men with normozoospermia and dysspermia. All participants answered a questionnaire which contains questions about the modifiable lifestyle factors. The total risk scores were calculated after all the positive lifestyle factors had been counted.
RESULTS


Men with normozoospermia and dysspermia consisted of 852 (65.0%) and 459 (35.0%) participants respectively. A negative relationship between the wearing of tight underwear and having normal semen parameters was detected between the two groups (p=0.004). While going to a sauna regularly was negatively related to semen concentration, wearing tight underwear was also related to both lower motility, normal morphology as well as semen concentration (p<0.05). While the total score of all participants was 5.22±1.34 point, there were no statistical differences between the two groups (p=0.332). It was found that having 3 more or fewer points was not related to any type of semen parameters and results of a spermiogram.
CONCLUSION


The clinicians should give advice to infertile male patients about changing their risky lifestyle, for infertility, to a healthy lifestyle for fertility. Better designed studies, with larger sample sizes using conventional semen analysis with sperm DNA analysis methods, should be planned to identify the possible effects of lifestyle factors on semen quality.",2020,A negative relationship between the wearing of tight underwear and having normal semen parameters was detected between the two groups (p=0.004).,"['All participants were separated into two groups as men with normozoospermia and dysspermia', 'infertile male patients', '1311 participants who attended the Andrology Clinic were included in the study', 'Men with normozoospermia and dysspermia consisted of 852 (65.0%) and 459 (35.0%) participants respectively']",[],"['total risk scores', 'lifestyle factors (body mass index, smoking, alcohol consumption, coffee intake, physical activity, sauna and cell phone usage, wearing tight-fitting underwear), and conventional semen parameters', 'semen quality', 'wearing of tight underwear and having normal semen parameters']","[{'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0085806', 'cui_str': 'Andrology'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0556160', 'cui_str': 'Coffee intake (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004836', 'cui_str': 'Baths, Finnish'}, {'cui': 'C1136359', 'cui_str': 'Cell Phone'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0453911', 'cui_str': 'Tights (physical object)'}, {'cui': 'C0453880', 'cui_str': 'Undergarment (physical object)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2717747', 'cui_str': 'Semen Quality'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]",1311.0,0.0217737,A negative relationship between the wearing of tight underwear and having normal semen parameters was detected between the two groups (p=0.004).,"[{'ForeName': 'Coşkun', 'Initials': 'C', 'LastName': 'Kaya', 'Affiliation': 'Eskisehir State Hospital, Department of Urology, Eskisehir, Turkey. Electronic address: coskun_kaya2008@yahoo.com.'}, {'ForeName': 'Aykut', 'Initials': 'A', 'LastName': 'Aykaç', 'Affiliation': 'Karabük University School of Medicine, Department of Urology, Karabük, Turkey.'}, {'ForeName': 'Yeliz', 'Initials': 'Y', 'LastName': 'Kaya', 'Affiliation': 'Eskisehir Osmangazi University Health Science Faculty Department of Nursing, Eskisehir, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Taş', 'Affiliation': 'Eskisehir State Hospital, Andrology Laboratory, Eskisehir, Turkey.'}]",Revista internacional de andrologia,['10.1016/j.androl.2019.09.001']
453,32406725,Are Fitbits implicated in body image concerns and disordered eating in women?,"OBJECTIVE


Using a daily monitoring framework, we examined the psychological consequences of Fitbit self-tracking on state body satisfaction, disordered eating (DE; i.e., binge eating and dietary restraint), levels of exercise engagement, and motivations (appearance vs. fitness/health) in adult women. A further aim within the Fitbit group was to assess whether the level of steps achieved on 1 day would be associated with the state-based outcome measures on the subsequent day.
METHOD


In total, 262 participants who had never used a wearable fitness self-tracking device were allocated to a Fitbit ( n  = 101) or control condition ( n  = 161). Participants provided baseline data on sociodemographics, eating pathology, and exercise and then completed a 10-day Ecological Momentary Assessment (EMA) protocol assessing exercise amount and motives, body satisfaction, and DE symptoms via a mobile application. Those in the Fitbit condition wore a Fitbit over the entire assessment period.
RESULTS


The use of a Fitbit over a 10-day period had no significant effects on exercise behavior or body satisfaction compared to a control group. However, those in the Fitbit group were more likely to exercise to reach fitness goals and less likely to engage in dietary restraint and binge-eating behavior. Among participants in the Fitbit condition, steps achieved the previous day were not predictive of exercise engagement, body satisfaction, or DE symptoms on the subsequent day.
CONCLUSIONS


Our study failed to link fitness self-tracking to body dissatisfaction and DE, at least in the early stages of use. Future research directions regarding alternative pathways through which self-tracking devices may exert negative influences are discussed. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,The use of a Fitbit over a 10-day period had no significant effects on exercise behavior or body satisfaction compared to a control group.,"['262 participants who had never used a wearable fitness self-tracking device', 'adult women']","['Fitbit self-tracking', 'control condition']","['dietary restraint and binge-eating behavior', '10-day Ecological Momentary Assessment (EMA) protocol assessing exercise amount and motives, body satisfaction, and DE symptoms via a mobile application', 'exercise behavior or body satisfaction', 'exercise engagement, body satisfaction, or DE symptoms', 'state body satisfaction, disordered eating (DE; i.e., binge eating and dietary restraint), levels of exercise engagement, and motivations (appearance vs. fitness/health']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",262.0,0.0275696,The use of a Fitbit over a 10-day period had no significant effects on exercise behavior or body satisfaction compared to a control group.,"[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Gittus', 'Affiliation': 'Melbourne School of Psychological Sciences.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Fuller-Tyszkiewicz', 'Affiliation': 'Centre for Social and Early Emotional Development.'}, {'ForeName': 'Haley E', 'Initials': 'HE', 'LastName': 'Brown', 'Affiliation': 'Melbourne School of Psychological Sciences.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Richardson', 'Affiliation': 'School of Psychology.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Fassnacht', 'Affiliation': 'Research School of Psychology.'}, {'ForeName': 'Georgina R', 'Initials': 'GR', 'LastName': 'Lennard', 'Affiliation': 'Research School of Psychology.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Holland', 'Affiliation': 'School of Psychological Sciences.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Krug', 'Affiliation': 'School of Psychological Sciences.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000881']
454,31479396,Tension-Free Vaginal Tape Surgery versus Polyacrylamide Hydrogel Injection for Primary Stress Urinary Incontinence: A Randomized Clinical Trial.,"PURPOSE


We evaluated whether polyacrylamide hydrogel is noninferior to tension-free vaginal tape to treat women with primary stress urinary incontinence.
MATERIALS AND METHODS


In this controlled noninferiority clinical trial patients with primary stress urinary incontinence were randomized to tension-free vaginal tape or polyacrylamide hydrogel treatment. The primary outcome was patient satisfaction and secondary outcomes were effectiveness in reducing urinary leakage and complications at 1-year followup. For statistical power significance was considered at 5%, power was set at 80% and the noninferiority limit was 20% with a 10% expected dropout rate.
RESULTS


A total of 224 women with primary stress urinary incontinence entered the study between September 28, 2015 and March 1, 2017. Of the women 111 were randomized to tension-free vaginal tape and 113 were randomized to polyacrylamide hydrogel. At 1 year a satisfaction score of 80 or greater on a visual analogue scale of 0 to 100 was reached in 95.0% and 59.8% of patients treated with tension-free vaginal tape and polyacrylamide hydrogel, respectively. Thus, polyacrylamide hydrogel did not meet the noninferiority criteria set in our study. As secondary outcomes, the cough stress test was negative in 95.0% of tension-free vaginal tape cases vs 66.4% of polyacrylamide hydrogel cases (difference 28.6%, 95% CI 18.4-38.5). However, most perioperative complications, including those in 19 tension-free vaginal tape cases vs 3 polyacrylamide hydrogel cases (difference 16.0%, 95% CI 7.8-24.9), and all 6 reoperations due to complications (difference 5.9%, 95% CI 1.2-12.4) were associated with tension-free vaginal tape.
CONCLUSIONS


Mid urethral tension-free vaginal tape slings were associated with better satisfaction and cure rates than polyacrylamide hydrogel in women with primary stress urinary incontinence. However, complications were mainly associated with tension-free vaginal tape. Thus, tension-free vaginal tape should be offered as first line treatment in women who expect to be completely cured by the initial treatment and are willing to accept the complication risks. Since polyacrylamide hydrogel treatment also provides high satisfaction and cure rates, women with primary stress urinary incontinence can be offered polyacrylamide hydrogel as an alternative treatment.",2020,"In secondary outcomes, the cough stress test was negative in 95.0% of TVT patients versus 66.4% of PAHG patients (difference 28.6%, 95% CI 18.4%-38.5%), whereas most peri-operative complications (TVT n=23 versus PAHG n=3, difference 20.0%, 95 % CI 11.2%-29.2%) and all (n=6) re-operations (difference 5.9%, 95 % CI 1.2%-12.4%), due to complications were associated with TVT.
","['Between September, 28, 2015 and March, 1, 2017, 224 women with primary SUI', 'women with primary stress urinary incontinence (SUI', 'primary SUI patients', 'Primary Stress Urinary Incontinence']","['tension-free vaginal tape (TVT', 'polyacrylamide hydrogel (PAHG', 'TVT', 'TVT or PAHG', 'TVT Surgery versus Bulkamid Injection', 'PAHG']","['peri-operative complications', 'patient satisfaction', 'urinary leakage and complications', 'satisfaction and cure rates', 'cough stress test', 'satisfaction score']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1721083', 'cui_str': 'Tension-Free Vaginal Tape'}, {'cui': 'C0137704', 'cui_str': 'polyacrylamide hydrogels'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2353119', 'cui_str': 'Bulkamid'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",224.0,0.0901504,"In secondary outcomes, the cough stress test was negative in 95.0% of TVT patients versus 66.4% of PAHG patients (difference 28.6%, 95% CI 18.4%-38.5%), whereas most peri-operative complications (TVT n=23 versus PAHG n=3, difference 20.0%, 95 % CI 11.2%-29.2%) and all (n=6) re-operations (difference 5.9%, 95 % CI 1.2%-12.4%), due to complications were associated with TVT.
","[{'ForeName': 'Anna-Maija', 'Initials': 'AM', 'LastName': 'Itkonen Freitas', 'Affiliation': 'Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Maarit', 'Initials': 'M', 'LastName': 'Mentula', 'Affiliation': 'Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Rahkola-Soisalo', 'Affiliation': 'Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Tulokas', 'Affiliation': 'Doctoral Programme in Clinical Research, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Tomi S', 'Initials': 'TS', 'LastName': 'Mikkola', 'Affiliation': 'Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}]",The Journal of urology,['10.1097/JU.0000000000000517']
455,31896529,Distress and anhedonia as predictors of depression treatment outcome: A secondary analysis of a randomized clinical trial.,"Two core features of depression include depressed mood (heightened distress) and anhedonia (reduced pleasure). Despite their centrality to depression, studies have not examined their contribution to treatment outcomes in a randomized clinical trial providing mainstream treatments like antidepressant medications (ADM) and cognitive therapy (CT). We used baseline distress and anhedonia derived from a factor analysis of the Mood and Anxiety Symptom Questionnaire to predict remission and recovery in 433 individuals with recurrent/chronic major depressive disorder. Patients were provided with only ADM or both ADM and CT. Overall, higher baseline distress and anhedonia predicted longer times to remission within one year and recovery within three years. When controlling for treatment condition, distress improved prediction of outcomes over and above anhedonia, while anhedonia did not improve prediction of outcomes over and above distress. Interactions with treatment condition demonstrated that individuals with higher distress and anhedonia benefited from receiving CT in addition to ADM, whereas there was no added benefit of CT for individuals with lower distress and anhedonia. Assessing distress and anhedonia prior to treatment may help select patients who will benefit most from CT in addition to ADM. For the treatments and outcome measures tested, utilizing distress to guide treatment planning may yield the greatest benefit. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00057577.",2020,"Interactions with treatment condition demonstrated that individuals with higher distress and anhedonia benefited from receiving CT in addition to ADM, whereas there was no added benefit of CT for individuals with lower distress and anhedonia.",['433 individuals with recurrent/chronic major depressive disorder'],"['cognitive therapy (CT', 'CT']","['Distress and anhedonia', 'depressed mood (heightened distress) and anhedonia (reduced pleasure']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0442803', 'cui_str': 'Heightened (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}]",433.0,0.0961218,"Interactions with treatment condition demonstrated that individuals with higher distress and anhedonia benefited from receiving CT in addition to ADM, whereas there was no added benefit of CT for individuals with lower distress and anhedonia.","[{'ForeName': 'Gabriela K', 'Initials': 'GK', 'LastName': 'Khazanov', 'Affiliation': 'Department of Psychology, University of Pennsylvania, 425 S. University Avenue, Philadelphia, PA, 19104, USA. Electronic address: kattang@sas.upenn.edu.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Psychology, University of Pennsylvania, 425 S. University Avenue, Philadelphia, PA, 19104, USA. Electronic address: colinxu@sas.upenn.edu.'}, {'ForeName': 'Barnaby D', 'Initials': 'BD', 'LastName': 'Dunn', 'Affiliation': 'Mood Disorders Centre, University of Exeter. Sir Henry Wellcome Building for Mood Disorders Research, University of Exeter, Perry Road, EX4 4QG, UK. Electronic address: B.D.Dunn@exeter.ac.uk.'}, {'ForeName': 'Zachary D', 'Initials': 'ZD', 'LastName': 'Cohen', 'Affiliation': 'Department of Psychology, University of Pennsylvania, 425 S. University Avenue, Philadelphia, PA, 19104, USA. Electronic address: zcohen@sas.upenn.edu.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'DeRubeis', 'Affiliation': 'Department of Psychology, University of Pennsylvania, 425 S. University Avenue, Philadelphia, PA, 19104, USA. Electronic address: derubeis@psych.upenn.edu.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Hollon', 'Affiliation': 'Department of Psychology, Vanderbilt University. 2301 Vanderbilt Place, Nashville, TN, 37240, USA. Electronic address: steven.d.hollon@vanderbilt.edu.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.103507']
456,31925317,A randomised phase II trial of hydroxychloroquine and imatinib versus imatinib alone for patients with chronic myeloid leukaemia in major cytogenetic response with residual disease.,"In chronic-phase chronic myeloid leukaemia (CP-CML), residual BCR-ABL1+ leukaemia stem cells are responsible for disease persistence despite TKI. Based on in vitro data, CHOICES (CHlorOquine and Imatinib Combination to Eliminate Stem cells) was an international, randomised phase II trial designed to study the safety and efficacy of imatinib (IM) and hydroxychloroquine (HCQ) compared with IM alone in CP-CML patients in major cytogenetic remission with residual disease detectable by qPCR. Sixty-two patients were randomly assigned to either arm. Treatment 'successes' was the primary end point, defined as ≥0.5 log reduction in 12-month qPCR level from trial entry. Selected secondary study end points were 24-month treatment 'successes', molecular response and progression at 12 and 24 months, comparison of IM levels, and achievement of blood HCQ levels >2000 ng/ml. At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21). At 24 months, the 'success' rate was 20.8% higher with IM/HCQ (p = 0.059). No patients progressed. Seventeen serious adverse events, including four serious adverse reactions, were reported; diarrhoea occurred more frequently with combination. IM/HCQ is tolerable in CP-CML, with modest improvement in qPCR levels at 12 and 24 months, suggesting autophagy inhibition maybe of clinical value in CP-CML.",2020,"At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21).","['2000', 'CP-CML patients in major cytogenetic remission with residual disease detectable by qPCR', 'patients with chronic myeloid leukaemia in major cytogenetic response with residual disease', 'Sixty-two patients']","['hydroxychloroquine and imatinib versus imatinib alone', 'IM/HCQ', 'imatinib (IM) and hydroxychloroquine (HCQ']","['MMR', 'diarrhoea', ""24-month treatment 'successes', molecular response and progression at 12 and 24 months, comparison of IM levels, and achievement of blood HCQ levels"", 'qPCR levels', ""success' rate""]","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4055168', 'cui_str': 'Cytogenetic response'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",62.0,0.0257648,"At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21).","[{'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Horne', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stobo', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mukhopadhyay', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Latif', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dixon-Hughes', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'McMahon', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cony-Makhoul', 'Affiliation': 'Haematology department, CH Annecy-Genevois, Pringy, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Byrne', 'Affiliation': 'Department of Haematology, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': ""Department of Haematology, St James's University Hospital, Leeds, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Koschmieder', 'Affiliation': 'Department of Medicine (Hematology Oncology, Hemostaseology, and Stem Cell Transplantation), Faculty of Medicine, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'BrÜmmendorf', 'Affiliation': 'Department of Medicine (Hematology Oncology, Hemostaseology, and Stem Cell Transplantation), Faculty of Medicine, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schafhausen', 'Affiliation': 'Department of Internal Medicine, University Medical Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gallipoli', 'Affiliation': 'Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Thomson', 'Affiliation': 'Experimental therapeutics, Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Cong', 'Affiliation': 'Experimental therapeutics, Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Clark', 'Affiliation': 'Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Milojkovic', 'Affiliation': 'Department of Haematology, Hammersmith Hospital, London, UK.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Helgason', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Foroni', 'Affiliation': 'Department of Haematology, Imperial College London, London, UK.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Nicolini', 'Affiliation': 'Hématologie Clinique and INSERM U1052, CRCL, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Holyoake', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Copland', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK. Mhairi.Copland@glasgow.ac.uk.""}]",Leukemia,['10.1038/s41375-019-0700-9']
457,31066988,Effect of Local Polyhexanide Application in Preventing Exit-Site Infection and Peritonitis: A Randomized Controlled Trial.,"Topical antibiotic and antiseptic agents have been documented to reduce exit-site infection (ESI) and peritonitis in PD. The aim of this randomized controlled study was to evaluate the efficacy of polyhexanide in the prevention of ESI and peritonitis. Patients were excluded if they had active infection, > 18 years of age, ESI and peritonitis within the previous 4 weeks, received PD for less than 3-months and history of allergy to either drug. All patients were followed up until catheter removal, death, switch to dialysis, transplantation or the end of the study. ESI, tunnel infection, peritonitis, catheter removal and microorganism cause of catheter-related infection were recorded prospectively during clinic follow-up. A total of 88 patients (41 povidone-iodine group; 47 polyhexanide group) were enrolled with a total follow-up duration of 480 and 555 patient-months for povidone-iodine and alternating group, respectively. There were no significant differences in the age, sex, BMI, time of PD, rate of DM, and S. aureus carriage state. A total of 8 ESI and 25 peritonitis episodes were detected during the study. ESI and peritonitis rates tended to be lower in polyhexanide group compared with the povidone-iodine group (0.06 episodes/patient-year vs. 0.12 episodes/patient-year; 0.26 episodes/patient-year vs. 0.32 episodes/patient-year, respectively), but were not significant statistically. Moreover, catheter removal was similar in both groups (0.04 / patient-year vs. 0.05 / patient-year). Polyhexanide is efficient and safe for the prevention of ESI and peritonitis and it may be used as an alternative procedure for the care of healthy exit sites.",2020,"ESI and peritonitis rates tended to be lower in polyhexanide group compared with the povidone-iodine group (0.06 episodes/patient-year vs. 0.12 episodes/patient-year; 0.26 episodes/patient-year vs. 0.32 episodes/patient-year, respectively), but were not significant statistically.","['88 patients (41 povidone-iodine group; 47 polyhexanide group) were enrolled with a total follow-up duration of 480 and 555 patient-months for', 'Exit-Site Infection and Peritonitis', 'Patients were excluded if they had active infection, > 18 years of age, ESI and peritonitis within the previous 4 weeks, received PD for less than 3-months and history of allergy to either drug']","['Topical antibiotic and antiseptic agents', 'povidone-iodine', 'povidone-iodine and alternating group, respectively', 'Local Polyhexanide Application', 'Polyhexanide', 'polyhexanide']","['age, sex, BMI, time of PD, rate of DM, and S. aureus carriage state', 'catheter removal', 'ESI and peritonitis rates', 'ESI, tunnel infection, peritonitis, catheter removal and microorganism cause of catheter-related infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0376892', 'cui_str': 'polihexanide'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C4517810', 'cui_str': 'Five hundred and fifty-five'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C3540796', 'cui_str': 'Antiseptic throat preparations'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0376892', 'cui_str': 'polihexanide'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter (procedure)'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0445623', 'cui_str': 'Microorganism (organism)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0860239', 'cui_str': 'Catheter-Associated Infections'}]",88.0,0.0716992,"ESI and peritonitis rates tended to be lower in polyhexanide group compared with the povidone-iodine group (0.06 episodes/patient-year vs. 0.12 episodes/patient-year; 0.26 episodes/patient-year vs. 0.32 episodes/patient-year, respectively), but were not significant statistically.","[{'ForeName': 'Mevlut', 'Initials': 'M', 'LastName': 'Ceri', 'Affiliation': 'Department of Nephrology, Pamukkale University Faculty of Medicine, Denizli, Turkey.'}, {'ForeName': 'Seref Rahmi', 'Initials': 'SR', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Nephrology, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Selman', 'Initials': 'S', 'LastName': 'Unverdi', 'Affiliation': 'Department of Nephrology, Sanko University Faculty of Medicine, Gaziantep, Turkey.'}, {'ForeName': 'Ilhan', 'Initials': 'I', 'LastName': 'Kurultak', 'Affiliation': 'Department of Nephrology, Trakya University Faculty of Medicine, Edirne, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Duranay', 'Affiliation': 'Department of Nephrology, Ankara Education and Research Hospital, Ankara, Turkey.'}]","Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy",['10.1111/1744-9987.12836']
458,31907074,"Tailored, psychological intervention for anxiety or depression in people with chronic obstructive pulmonary disease (COPD), TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD): protocol for a randomised controlled trial.","BACKGROUND


People with chronic obstructive pulmonary disease (COPD) are at increased risk of depression and anxiety, which greatly reduces their quality of life and is associated with worse outcomes; but these psychological co-morbidities are under-recognised and undertreated in COPD patients. Pulmonary rehabilitation (PR) improves mood for up to 6 months but health practitioners under-refer, and patients commonly fail to attend/complete PR. Research suggests that complex non-pharmacological interventions, including both psychological and exercise components, may reduce anxiety and depression in COPD. We have developed a tailored, cognitive behavioural approach (CBA) intervention for patients with COPD and co-morbid anxiety and/or depression ('TANDEM'), which precedes and optimises the benefits of currently offered PR. We hypothesise that such a psychological intervention, delivered by supervised, trained respiratory healthcare professionals, will improve mood in patients with mild to moderate anxiety and/or depression and encourage uptake and completion of PR.
METHODS


We will conduct a multi-centre, pragmatic, randomised controlled trial of the TANDEM intervention compared to usual care across the Midlands, London, the South East and Bristol, UK. We will train healthcare professionals familiar with COPD to deliver the manualised, tailored, face-to-face, one-to-one intervention weekly for 6-8 weeks. We will recruit 430 participants from primary, community and secondary care with confirmed COPD and moderate to very severe airflow limitation, who are eligible for assessment for PR, and who screen positive for symptoms of mild/moderate depression and/or anxiety using the Hospital Anxiety and Depression scale (HADS). Participants will be randomised 1.25:1 (intervention: usual care). The co-primary outcomes are the HADS anxiety and depression subscale scores at 6 months; participants will be followed up to 12 months. Secondary outcomes include uptake and completion of PR and healthcare resource use. There will be a parallel process evaluation and a health economic evaluation.
DISCUSSION


The TANDEM intervention has the potential to optimise the unrealised synergy between a psychological intervention and PR. The CBA sessions will precede PR and target individuals' cognitions, behaviours and symptoms associated with anxiety and depression to decrease psychological morbidity and increase effective self-management amongst patients with COPD.
TRIAL REGISTRATION


ISRCTN, ID: ISRCTN59537391. Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.",2020,"We have developed a tailored, cognitive behavioural approach (CBA) intervention for patients with COPD and co-morbid anxiety and/or depression ('TANDEM'), which precedes and optimises the benefits of currently offered PR.","['people with chronic obstructive pulmonary disease (COPD', '430 participants from primary, community and secondary care with confirmed COPD and moderate to very severe airflow limitation, who are eligible for assessment for PR, and who screen positive for symptoms of mild/moderate depression and/or anxiety using the Hospital Anxiety and Depression scale (HADS', ""patients with COPD and co-morbid anxiety and/or depression ('TANDEM"", 'People with chronic obstructive pulmonary disease (COPD', 'usual care across the Midlands, London, the South East and Bristol, UK', 'patients with COPD', 'patients with mild to moderate anxiety and/or depression and encourage uptake and completion of PR']","['Pulmonary rehabilitation (PR', 'cognitive behavioural approach (CBA) intervention', 'psychological intervention']","['psychological morbidity', 'HADS anxiety and depression subscale scores', 'uptake and completion of PR and healthcare resource use']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C3641272', 'cui_str': 'Extreme'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression (disorder)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",430.0,0.101872,"We have developed a tailored, cognitive behavioural approach (CBA) intervention for patients with COPD and co-morbid anxiety and/or depression ('TANDEM'), which precedes and optimises the benefits of currently offered PR.","[{'ForeName': 'Ratna', 'Initials': 'R', 'LastName': 'Sohanpal', 'Affiliation': 'Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Pinnock', 'Affiliation': 'Allergy and Respiratory Research Group, Usher Institute of Population Health Sciences and Informatics, Doorway 3, Medical School, Teviot Place, Edinburgh, EH8 9AG, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Steed', 'Affiliation': 'Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Heslop Marshall', 'Affiliation': 'Newcastle upon Tyne NHS Hospitals Foundation Trust, Chest Clinic, New Victoria Wing RVI Hospital, Queen Victoria Road, Newcastle upon Tyne, NE1 4LP, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Chan', 'Affiliation': 'Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Kelly', 'Affiliation': 'Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Priebe', 'Affiliation': 'Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Roberts', 'Affiliation': 'Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Respiratory Sciences, College of Life Sciences, NIHR Leicester Biomedical Research Centre - Respiratory, Glenfield Hospital, University of Leicester, Groby Road, Leicester, LE3 9QP, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Smuk', 'Affiliation': 'Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Saqi-Waseem', 'Affiliation': 'Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Healey', 'Affiliation': ""King's Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Warwick CTU, Warwick Medical School, Gibbet Hill Road, Coventry, CV4 7AL and University Hospitals of Coventry and Warwickshire, Clifford Bridge Road, Coventry, CV2 2DX, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'White', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, Great Maze Pond, London, SE1 1UL, UK.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Warburton', 'Affiliation': ', London, UK.'}, {'ForeName': 'Stephanie J C', 'Initials': 'SJC', 'LastName': 'Taylor', 'Affiliation': 'Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK. s.j.c.taylor@qmul.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3800-y']
459,31907537,The Effect of Cigarette Packaging and Illness Sensitivity on Attention to Graphic Health Warnings: A Controlled Study.,"INTRODUCTION


The social and health care costs of smoking are immense. To reduce these costs, several tobacco control policies have been introduced (eg, graphic health warnings [GHWs] on cigarette packs). Previous research has found plain packaging (a homogenized form of packaging), in comparison to branded packaging, effectively increases attention to GHWs using UK packaging prototypes. Past studies have also found that illness sensitivity (IS) protects against health-impairing behaviors. Building on this evidence, the goal of the current study was to assess the effect of packaging type (plain vs. branded), IS level, and their interaction on attention to GHWs on cigarette packages using proposed Canadian prototypes.
AIMS AND METHODS


We assessed the dwell time and fixations on the GHW component of 40 cigarette pack stimuli (20 branded; 20 plain). Stimuli were presented in random order to 50 smokers (60.8% male; mean age = 33.1; 92.2% daily smokers) using the EyeLink 1000 system. Participants were divided into low IS (n = 25) and high IS (n = 25) groups based on scores on the Illness Sensitivity Index.
RESULTS


Overall, plain packaging relative to branded packaging increased fixations (but not dwell time) on GHWs. Moreover, low IS (but not high IS) smokers showed more fixations to GHWs on plain versus branded packages.
CONCLUSIONS


These findings demonstrate that plain packaging is a promising intervention for daily smokers, particularly those low in IS, and contribute evidence in support of impending implementation of plain packaging in Canada.
IMPLICATIONS


Our findings have three important implications. First, our study provides controlled experimental evidence that plain packaging is a promising intervention for daily smokers. Second, the findings of this study contribute supportive evidence for the impending plain packaging policy in Canada, and can therefore aid in defense against anticipated challenges from the tobacco industry upon its implementation. Third, given its effects in increasing attention to GHWs, plain packaging is an intervention likely to provide smokers enhanced incentive for smoking cessation, particularly among those low in IS who may otherwise be less interested in seeking treatment for tobacco dependence.",2020,"Previous research has found plain packaging (a homogenized form of packaging), in comparison to branded packaging, effectively increases attention to GHWs using UK packaging prototypes.",['50 smokers (60.8% male'],"['Cigarette Packaging and Illness Sensitivity on Attention to Graphic Health Warnings', 'packaging type (plain versus branded']",['dwell time and fixations on the GHW component of 40 cigarette pack stimuli'],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0030176', 'cui_str': 'Packaging'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0429659', 'cui_str': 'Dwell time (observable entity)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]",1000.0,0.0152278,"Previous research has found plain packaging (a homogenized form of packaging), in comparison to branded packaging, effectively increases attention to GHWs using UK packaging prototypes.","[{'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Hardardottir', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Al-Hamdani', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Klein', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Hurst', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Sherry H', 'Initials': 'SH', 'LastName': 'Stewart', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, Canada.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz243']
460,31880796,Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial.,"Importance


Insomnia disorder is prevalent and associated with health risks in older adults; however, efficacy and safety issues with existing treatments create significant unmet needs in this patient population.
Objective


To compare treatment with the orexin receptor antagonist lemborexant with placebo and zolpidem tartrate extended release in participants with insomnia disorder.
Design, Setting, and Participants


The Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1) clinical trial was a global randomized double-blind parallel-group placebo-controlled active-comparator phase 3 study conducted at 67 sites in North America and Europe from May 31, 2016, to January 30, 2018. Data analyses were conducted from January 31, 2018, to September 10, 2018. Participants were 55 years and older with insomnia disorder characterized by reported sleep maintenance difficulties and confirmed by sleep history, sleep diary, and polysomnography. Participants could have also had sleep onset difficulties.
Interventions


Participants received placebo, zolpidem tartrate extended release (6.25 mg), or lemborexant (5 mg or 10 mg) for 1 month at bedtime.
Main Outcomes and Measures


Paired polysomnograms were collected at baseline, the first 2 nights, and the last 2 nights of treatment. The primary end point was the change from baseline in latency to persistent sleep for lemborexant therapy vs placebo. Key secondary end points were changes from baseline in sleep efficiency and wake-after-sleep onset compared with placebo, and wake-after-sleep onset in the second half of the night compared with zolpidem therapy.
Results


Among 1006 participants randomized (placebo, n = 208; zolpidem, n = 263; lemborexant 5 mg, n = 266; and lemborexant 10 mg, n = 269), 869 (86.4%) were women and the median age was 63 years (range, 55-88 years). Both doses of lemborexant therapy demonstrated statistically significant greater changes from baseline on objective sleep onset as assessed by latency to persistent sleep (log transformed) that was measured using polysomnography at the end of 1 month of treatment (nights 29 and 30) compared with placebo (primary end point for least squares geometric means treatment ratio vs placebo: for lemborexant 5 mg, 0.77; 95% CI, 0.67-0.89; P < .001; for lemborexant 10 mg, 0.72; 95% CI, 0.63-0.83; P < .001). For nights 29 and 30, as measured using polysomnography, the mean change from baseline in sleep efficiency (LSM treatment difference vs placebo for lemborexant 5 mg, 7.1%; 95% CI, 5.6%-8.5%; P < .001 and for lemborexant 10 mg, 8.0%; 95% CI, 6.6%-9.5%; P < .001) and wake-after-sleep onset (least squares mean treatment ratio vs placebo for lemborexant 5 mg, -24.0 min; 95% CI, -30.0 to -18.0 min; P < .001 and for lemborexant 10 mg, -25.4 min; 95% CI, -31.4 to -19.3 min; P < .001) were significantly greater for both doses of lemborexant therapy compared with placebo. Also, for nights 29 and 30, wake-after-sleep onset in the second half of the night (least squares mean treatment difference vs zolpidem for lemborexant 5 mg, -6.7 min; 95% CI, -11.2 to -2.2 min; P = .004 and for lemborexant 10 mg, -8.0 min; 95% CI, -12.5 to -3.5 min; P < .001) was significantly greater for both doses of lemborexant therapy compared with zolpidem therapy measured using polysomnography. Six participants (4 in the zolpidem group and 2 in the lemborexant 5 mg group) reported serious adverse events; none were treatment-related. Other adverse events were mostly mild or moderate in severity.
Conclusions and Relevance


In this randomized clinical trial, lemborexant therapy significantly improved both sleep onset and sleep maintenance, including in the second half of the night, compared with both placebo and zolpidem measured objectively using polysomnography. Lemborexant therapy was well tolerated.
Trial Registrations


ClinicalTrials.gov identifier: NCT02783729; EudraCT identifier: 2015-001463-39.",2019,"Both doses of lemborexant therapy demonstrated statistically significant greater changes from baseline on objective sleep onset as assessed by latency to persistent sleep (log transformed) that was measured using polysomnography at the end of 1 month of treatment (nights 29 and 30) compared with placebo (primary end point for least squares geometric means treatment ratio vs placebo: for lemborexant 5 mg, 0.77; 95% CI, 0.67-0.89; P < .001; for lemborexant 10 mg, 0.72; 95% CI, 0.63-0.83; P < .001).","['phase 3 study conducted at 67 sites in North America and Europe from May 31, 2016, to January 30, 2018', '1006 participants randomized', 'older adults', '10 mg, n\u2009=\u2009269), 869 (86.4%) were women and the median age was 63 years (range, 55-88 years', 'Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1', 'Older Adults With Insomnia Disorder', 'participants with insomnia disorder', 'Participants were 55 years and older with insomnia disorder characterized by reported sleep maintenance difficulties and confirmed by sleep history, sleep diary, and polysomnography']","['zolpidem', 'placebo and zolpidem', 'orexin receptor antagonist lemborexant with placebo and zolpidem tartrate', 'Lemborexant With Placebo', 'Zolpidem Tartrate', 'placebo, zolpidem tartrate extended release (6.25 mg), or lemborexant', 'zolpidem, n\u2009=\u2009263; lemborexant 5 mg, n\u2009=\u2009266; and lemborexant', 'Lemborexant therapy', 'placebo', 'Lemborexant', 'placebo-controlled active-comparator', 'lemborexant therapy vs placebo', 'lemborexant therapy']","['serious adverse events', 'sleep efficiency', 'objective sleep onset', 'sleep onset difficulties', 'sleep efficiency and wake-after-sleep onset compared with placebo, and wake-after-sleep onset', 'sleep onset and sleep maintenance', 'latency to persistent sleep', 'tolerated']","[{'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}]","[{'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4019081', 'cui_str': 'Orexin Receptor Blockers'}, {'cui': 'C0724725', 'cui_str': 'Zolpidem tartrate'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4517821', 'cui_str': '6.25'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]",1006.0,0.534433,"Both doses of lemborexant therapy demonstrated statistically significant greater changes from baseline on objective sleep onset as assessed by latency to persistent sleep (log transformed) that was measured using polysomnography at the end of 1 month of treatment (nights 29 and 30) compared with placebo (primary end point for least squares geometric means treatment ratio vs placebo: for lemborexant 5 mg, 0.77; 95% CI, 0.67-0.89; P < .001; for lemborexant 10 mg, 0.72; 95% CI, 0.63-0.83; P < .001).","[{'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Rosenberg', 'Affiliation': 'NeuroTrials Research, Atlanta, Georgia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Murphy', 'Affiliation': 'ICON, North Wales, Pennsylvania.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Zammit', 'Affiliation': 'Clinilabs, New York, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mayleben', 'Affiliation': 'Community Research, Cincinnati, Ohio.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Dhadda', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}, {'ForeName': 'Gleb', 'Initials': 'G', 'LastName': 'Filippov', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'LoPresti', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Moline', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.18254']
461,31880827,Muscle and fat aftereffects and the role of gender: Implications for body image disturbance.,"Body image disturbance - a cause of distress amongst the general population and those diagnosed with various disorders - is often attributed to the media's unrealistic depiction of ideal bodies. These ideals are strongly gendered, leading to pronounced fat concern amongst females, and a male preoccupation with muscularity. Recent research suggests that visual aftereffects may be fundamental to the misperception of body fat and muscle mass - the perceptual component of body image disturbance. This study sought to establish the influence of gender on these body aftereffects. Male and female observers were randomly assigned to one of four adaptation conditions (low-fat, high-fat, low-muscle, and high-muscle bodies) and were asked to adjust the apparent fat and muscle levels of male and female bodies to make them appear as 'normal' as possible both before adaptation and after adaptation. While neither the gender of observers nor of body stimuli had a direct effect, aftereffect magnitude was significantly larger when observers viewed own-gender (compared with other-gender) stimuli. This effect, which may be due to attentional factors, could have implications for the development of body image disturbance, given the preponderance of idealized own-gender bodies in media marketed to male and female consumers.",2020,Body image disturbance - a cause of distress amongst the general population and those diagnosed with various disorders - is often attributed to the media's unrealistic depiction of ideal bodies.,['Male and female observers'],[],['Muscle and fat aftereffects'],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]",[],"[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1368999', 'cui_str': 'Late effect of'}]",,0.0260617,Body image disturbance - a cause of distress amongst the general population and those diagnosed with various disorders - is often attributed to the media's unrealistic depiction of ideal bodies.,"[{'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Brooks', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Edwina', 'Initials': 'E', 'LastName': 'Keen', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sturman', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mond', 'Affiliation': 'Centre for Rural Health, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Stevenson', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Stephen', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, New South Wales, Australia.'}]","British journal of psychology (London, England : 1953)",['10.1111/bjop.12439']
462,31680344,"Small-bowel capsule endoscopy in patients with celiac disease, axial versus lateral/panoramic view: Results from a prospective randomized trial.","BACKGROUND AND AIM


Capsule enteroscopy (CE) is recommended in the management of complicated celiac disease (CD). However, published data are derived from axial-view capsule systems. No data are available on the use of lateral/panoramic view capsules. This study aimed at evaluating the diagnostic yield and efficacy of the lateral/panoramic versus the axial view capsule system in CD.
METHODS


Consecutive CD patients were enrolled in a prospective monocentric study. Each patient ingested an axial (PillCam SB3) and a lateral/panoramic (CapsoCam Plus) view capsule with a 3-h interval in a randomized order. Two experts blindly evaluated the CE carried out. A third expert reviewed the videos in cases of discordance.
RESULTS


Twenty-five CD patients were enrolled (four males, age at CE 51.2 ± 16.6 years, age at CD diagnosis 41.7 ± 20.6, years on a gluten-free diet [GFD] 9.6 ± 9.4). Indications at CE were refractory CD in nine cases, non-responsiveness to GFD in 10 and GFD non-compliance in six. A positive finding was evidenced in 15 (60%) and 13 (52%) cases by CapsoCam and PillCam respectively (not significant). Atrophy was detected by both capsules. Considering the percentage of the small-bowel mucosa presenting atrophy signs, mean values were 22% ± 35 and 20% ± 29 for lateral/panoramic and axial systems, respectively (not significant). Compared to duodenal histology, PillCam correctly identified 80% of patients with SB atrophy, whereas CapsoCam identified 73% of cases.
CONCLUSIONS


Lateral/panoramic view CE is effective in the detection of small-bowel atrophy in CD and presents good sensitivity and specificity when compared to histology.",2020,"Compared to duodenal histology, PillCam correctly identified 80% of patients with SB atrophy, CapsoCam 73% of cases.
","['complicated celiac disease (CD', 'patients with celiac disease, axial vs. lateral/panoramic view', 'Consecutive CD patients', '25 CD patients were enrolled (4 males, age at CE 51±16, age at CD diagnosis 42±20 years on a gluten-free diet (GFD) 10±9']","['axial (PillCam SB3) and a lateral/panoramic (CapsoCam Plus) view capsule', 'Capsule enteroscopy (CE', 'Small-bowel capsule endoscopy']",['Atrophy'],"[{'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0344351', 'cui_str': 'Gluten-Free Diet'}]","[{'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0399619', 'cui_str': 'Enteroscopy (procedure)'}, {'cui': 'C4285996', 'cui_str': 'Small bowel capsule endoscopy'}]","[{'cui': 'C0333641', 'cui_str': 'Atrophy'}]",25.0,0.0237156,"Compared to duodenal histology, PillCam correctly identified 80% of patients with SB atrophy, CapsoCam 73% of cases.
","[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Branchi', 'Affiliation': ""Division of Gastroenterology and Endoscopy, Center for Prevention and Diagnosis of Celiac Disease, Foundation IRCCS Ca' Granda Major Polyclinic Hospital, Milan, Italy.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ferretti', 'Affiliation': ""Division of Gastroenterology and Endoscopy, Center for Prevention and Diagnosis of Celiac Disease, Foundation IRCCS Ca' Granda Major Polyclinic Hospital, Milan, Italy.""}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Orlando', 'Affiliation': ""Division of Gastroenterology and Endoscopy, Center for Prevention and Diagnosis of Celiac Disease, Foundation IRCCS Ca' Granda Major Polyclinic Hospital, Milan, Italy.""}, {'ForeName': 'Gian Eugenio', 'Initials': 'GE', 'LastName': 'Tontini', 'Affiliation': ""Division of Gastroenterology and Endoscopy, Center for Prevention and Diagnosis of Celiac Disease, Foundation IRCCS Ca' Granda Major Polyclinic Hospital, Milan, Italy.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Penagini', 'Affiliation': ""Division of Gastroenterology and Endoscopy, Center for Prevention and Diagnosis of Celiac Disease, Foundation IRCCS Ca' Granda Major Polyclinic Hospital, Milan, Italy.""}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Vecchi', 'Affiliation': ""Division of Gastroenterology and Endoscopy, Center for Prevention and Diagnosis of Celiac Disease, Foundation IRCCS Ca' Granda Major Polyclinic Hospital, Milan, Italy.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Elli', 'Affiliation': ""Division of Gastroenterology and Endoscopy, Center for Prevention and Diagnosis of Celiac Disease, Foundation IRCCS Ca' Granda Major Polyclinic Hospital, Milan, Italy.""}]",Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society,['10.1111/den.13575']
463,31907024,Blood biomarkers as surrogate endpoints of treatment responses to aerobic exercise and cognitive training (ACT) in amnestic mild cognitive impairment: the blood biomarkers study protocol of a randomized controlled trial (the ACT Trial).,"BACKGROUND


Alzheimer's disease (AD) is an epidemic with tremendous public health impacts because there are currently no disease-modifying therapeutics. Randomized controlled trials (RCTs) for prevention of AD dementia often use clinical endpoints that take years to manifest (e.g., cognition) or surrogate endpoints that are costly or invasive (e.g., magnetic resonance imaging [MRI]). Blood biomarkers represent a clinically applicable alternative surrogate endpoint for RCTs that would be both cost-effective and minimally invasive, but little is known about their value as surrogate endpoints for treatment responses in the prevention of AD dementia.
METHODS


The objective of this study is to investigate blood neuropathological, neurodegenerative, and neurotrophic biomarkers as surrogate endpoints for treatment responses to three interventions in older adults with amnestic mild cognitive impairment (aMCI, a prodromal stage of AD): aerobic exercise, cognitive training, and combined aerobic exercise and cognitive training (ACT). We chose these three sets of biomarkers for their unique mechanistic associations with AD pathology, neurodegeneration and neurogenesis. This study is built on the ACT Trial (1R01AG055469), a single-blinded, multi-site, 2 × 2 factorial phase II RCT that examines the synergistic effects of a 6-month ACT intervention on cognition and MRI biomarkers (AD-signature cortical thickness and hippocampal volume) (n = 128). In this ACT Trial blood biomarkers study, we will enroll 120 ACT Trial participants with aMCI and measure blood biomarkers at baseline and at 3, 6, 12, and 18 months. The goals are to (1) determine the effect of interventions on blood biomarkers over 6 months, (2) evaluate blood biomarkers as surrogate endpoints for predicting cognitive responses to interventions over 18 months, and (3, exploratory) examine blood biomarkers as surrogate endpoints for predicting brain MRI biomarker responses to interventions over 18 months.
DISCUSSION


This study aims to identify new blood biomarkers that can track cognitive decline or AD-related brain atrophy among patients with aMCI subjected to a regimen of aerobic exercise and cognitive training. Findings from this study will drive the further use of blood biomarkers in developing effective prevention and treatment strategies for AD dementia.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03313895. Registered on 18 October 2017.",2020,This study aims to identify new blood biomarkers that can track cognitive decline or AD-related brain atrophy among patients with aMCI subjected to a regimen of aerobic exercise and cognitive training.,"['enroll 120 ACT Trial participants with aMCI and measure blood biomarkers at baseline and at 3, 6, 12, and 18\u2009months', 'amnestic mild cognitive impairment', 'older adults with amnestic mild cognitive impairment (aMCI, a prodromal stage of AD', ""Alzheimer's disease (AD"", 'patients with aMCI subjected to a regimen of']","['aerobic exercise, cognitive training, and combined aerobic exercise and cognitive training (ACT', 'aerobic exercise and cognitive training (ACT', 'aerobic exercise and cognitive training', 'ACT intervention']","['cognition and MRI biomarkers (AD-signature cortical thickness and hippocampal volume', 'blood biomarkers']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3494361', 'cui_str': 'Prodromal Stage'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",120.0,0.163219,This study aims to identify new blood biomarkers that can track cognitive decline or AD-related brain atrophy among patients with aMCI subjected to a regimen of aerobic exercise and cognitive training.,"[{'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Lab Medicine and Pathology, University of Minnesota, 420 Delaware Street SE, MMC 609, Minneapolis, MN, 55455, USA. dannili@umn.edu.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Mielke', 'Affiliation': 'Department of Neurology and Health Sciences Research, Mayo Clinic College of Medicine, Rochester, MN, 55902, USA.'}, {'ForeName': 'W Robert', 'Initials': 'WR', 'LastName': 'Bell', 'Affiliation': 'Department of Lab Medicine and Pathology, University of Minnesota, 420 Delaware Street SE, MMC 609, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Cavan', 'Initials': 'C', 'LastName': 'Reilly', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Feng Vankee', 'Initials': 'FV', 'LastName': 'Lin', 'Affiliation': 'University of Rochester Medical Center, 601 Elmwood Ave, Rochester, NY 14642, USA.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'School of Nursing, University of Minnesota, 5-140 WDH, 308 Harvard St SE, Minneapolis, MN, 55455, USA. yuxxx244@umn.edu.'}]",Trials,['10.1186/s13063-019-3798-1']
464,31194638,Antigen-Specific Immunotherapy with Thyrotropin Receptor Peptides in Graves' Hyperthyroidism: A Phase I Study.,"Background:  Graves' disease is one of the most common autoimmune conditions, but treatment remains imperfect. This study explores the first-in-human use of antigen-specific immunotherapy with a combination of two thyrotropin receptor (TSHR) peptides (termed ATX-GD-59) in Graves' hyperthyroidism.  Methods:  Twelve participants (11 female) with previously untreated mild to moderate Graves' hyperthyroidism were enrolled in a Phase I open label trial to receive 10 doses of ATX-GD-59 administered intradermally over an 18-week period. Adverse events, tolerability, changes in serum free thyroid hormones, and TSHR autoantibodies were measured.  Results:  Ten subjects received all 10 doses of ATX-GD-59, five (50%) of whom had free triiodothyronine within the reference interval by the 18-week visit. Two further subjects had improved free thyroid hormones by the end of the study (7/10 responders), whereas three subjects showed worsening thyrotoxicosis during the study. Serum TSHR autoantibody concentrations reduced during the study and correlated with changes in free thyroid hormones ( r  = 0.85,  p  = 0.002 for TSHR autoantibody vs. free triiodothyronine). Mild injection-site swelling and pain were the most common adverse events.  Conclusions:  These preliminary data suggest that ATX-GD-59 is a safe and well-tolerated treatment. The improvement in free thyroid hormones in 70% of subjects receiving the medication suggests potential efficacy as a novel treatment for Graves' hyperthyroidism.",2019,The improvement in free thyroid hormones in 70% of subjects receiving the medication suggests potential efficacy as a novel treatment for Graves' hyperthyroidism.,"[""Twelve participants (11 female) with previously untreated mild to moderate Graves' hyperthyroidism"", ""Graves' Hyperthyroidism"", ""Graves' hyperthyroidism""]","['Antigen-Specific Immunotherapy with Thyrotropin Receptor Peptides', 'ATX-GD-59', 'triiodothyronine', 'two thyrotropin receptor (TSHR) peptides (termed ATX-GD-59']","['worsening thyrotoxicosis', 'Adverse events, tolerability, changes in serum free thyroid hormones, and TSHR autoantibodies', 'free thyroid hormones', 'Serum TSHR autoantibody concentrations', 'Mild injection-site swelling and pain']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C2609423', 'cui_str': 'Hyperthyroidism (SMQ)'}]","[{'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0034844', 'cui_str': 'Thyrotropin Receptor'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}]","[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0040156', 'cui_str': 'Thyrotoxicosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4522017', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0004358', 'cui_str': 'Autoantibodies'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0221208', 'cui_str': 'Injection site (morphologic abnormality)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",2.0,0.0350004,The improvement in free thyroid hormones in 70% of subjects receiving the medication suggests potential efficacy as a novel treatment for Graves' hyperthyroidism.,"[{'ForeName': 'Simon H S', 'Initials': 'SHS', 'LastName': 'Pearce', 'Affiliation': '1Institute for Genetic Medicine, Newcastle University, and Newcastle Hospitals NHS Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Dayan', 'Affiliation': '2Thyroid Research Group, School of Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wraith', 'Affiliation': '3Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham United Kingdom.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Barrell', 'Affiliation': '4Apitope Technology (Bristol) Ltd., Chepstow, United Kingdom.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Olive', 'Affiliation': '4Apitope Technology (Bristol) Ltd., Chepstow, United Kingdom.'}, {'ForeName': 'Lotta', 'Initials': 'L', 'LastName': 'Jansson', 'Affiliation': '5Apitope International NV, Diepenbeek, Belgium.'}, {'ForeName': 'Terrie', 'Initials': 'T', 'LastName': 'Walker-Smith', 'Affiliation': '4Apitope Technology (Bristol) Ltd., Chepstow, United Kingdom.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Carnegie', 'Affiliation': '4Apitope Technology (Bristol) Ltd., Chepstow, United Kingdom.'}, {'ForeName': 'Keith F', 'Initials': 'KF', 'LastName': 'Martin', 'Affiliation': '4Apitope Technology (Bristol) Ltd., Chepstow, United Kingdom.'}, {'ForeName': 'Kristien', 'Initials': 'K', 'LastName': 'Boelaert', 'Affiliation': '6Institute of Metabolism and Systems Research, University of Birmingham, Birmingham United Kingdom.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Gilbert', 'Affiliation': ""7Department of Endocrinology, King's College Hospital, London, United Kingdom.""}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Higham', 'Affiliation': '8Department of Endocrinology, Christie Hospital NHS Foundation Trust, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Muller', 'Affiliation': '2Thyroid Research Group, School of Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Murray', 'Affiliation': ""9Department of Endocrinology, St. James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Perros', 'Affiliation': '10Endocrine Unit, Newcastle Hospitals NHS Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Salman', 'Initials': 'S', 'LastName': 'Razvi', 'Affiliation': '11Institute for Genetic Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Bijay', 'Initials': 'B', 'LastName': 'Vaidya', 'Affiliation': '12Macleod Diabetes & Endocrine Centre, Royal Devon and Exeter Hospital, Exeter, United Kingdom.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Wernig', 'Affiliation': '13Department of Endocrinology, Imperial College, London, United Kingdom.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Kahaly', 'Affiliation': '14Department of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2019.0036']
465,31319427,Effects of Pre- and Post-Exercise Cold-Water Immersion Therapy on Passive Muscle Stiffness.,"BACKGROUND


Cold-water immersion (CWI) has become a popular preventive, regenerative and performance-enhancing intervention in various sports. However, its effects on soft tissue, including changes of intramuscular stiffness, are poorly understood. The purpose of this study was to investigate the effect of CWI on muscle stiffness.
PATIENTS/MATERIAL AND METHODS


Thirty healthy participants were included and divided into the three following groups (n = 10): 1) post-ESU group: exercise and CWI (post-exercise set-up); 2) control group: exercise without CWI (control condition); 3) pre-ESU group: CWI alone (pre-exercise set-up). Acoustic radiation force impulse (ARFI) elastography was conducted to assess tissue stiffness (shear wave velocity, SWV). Values obtained at resting conditions (baseline, t0) were compared to values post-exercise (t1, for post-ESU group and control group), post-CWI (t2, for post-ESU group and pre-ESU group; rest for control group) and to 60-min follow-up time (t3, for all groups). Data were assessed in superficial and deep muscle tissue (rectus femoris muscle, RF; vastus intermedius muscle, VI).
RESULTS


For the post-ESU group (CWI post-exercise), there was no significant difference between the time points of measurements: exercise (t1: RF: 1.63 m/s; VI: 1.54 m/s), CWI (t2: RF: 1.63 m/s; VI: 1.53 m/s) and at 60-min follow-up (t3: RF: 1.72 m/s; VI: 1.61 m/s). In the control group, a significant decrease of SWV was found between baseline conditions at t0 and post-exercise (t1) at VI (VI: 1.37 m/s; p = 0.004; RF: 1.59 m/s; p = 0.084). For t2 and t3, no further significant changes were detected. Regarding the pre-exercise set-up (pre-ESU group), a significant decrease in SWV from baseline to t2 in VI (1.60 m/s to 1.49 m/s; VI: p = 0.027) was found.
CONCLUSION


This study shows varying influences of CWI on muscle stiffness. Overall, we did not detect any significant effects of CWI on muscle stiffness post-exercise. Muscle stiffness-related effects of CWI differ in the context of a pre- or post-exercise condition and have to be considered in the implementation of CWI to ensure its potential preventive and regenerative benefits.",2020,"In the control group, a significant decrease of SWV was found between baseline conditions at t0 and post-exercise (t1) at VI (VI: 1.37 m/s; p = 0.004; RF: 1.59 m/s; p = 0.084).",['Thirty healthy participants'],"['Cold-water immersion (CWI', 'Acoustic radiation force impulse (ARFI) elastography', 'CWI', 'ESU group: exercise and CWI (post-exercise set-up); 2) control group: exercise without CWI (control condition); 3) pre-ESU group: CWI alone (pre-exercise set-up', 'Pre- and Post-Exercise Cold-Water Immersion Therapy']","['tissue stiffness (shear wave velocity, SWV', 'Passive Muscle Stiffness', 'superficial and deep muscle tissue (rectus femoris muscle, RF; vastus intermedius muscle, VI', 'SWV']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C1455736', 'cui_str': 'Acoustic radiations structure'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C1955928', 'cui_str': 'Elastography'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0584894', 'cui_str': 'Rectus Femoris'}, {'cui': 'C0224448', 'cui_str': 'Vastus Intermedius'}]",30.0,0.060789,"In the control group, a significant decrease of SWV was found between baseline conditions at t0 and post-exercise (t1) at VI (VI: 1.37 m/s; p = 0.004; RF: 1.59 m/s; p = 0.084).","[{'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Hüttel', 'Affiliation': 'Department of Orthopedic Surgery, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Golditz', 'Affiliation': 'Department of Orthopedic Trauma Surgery, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nuremberg Germany, Erlangen, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Mayer', 'Affiliation': 'Department of Orthopedic Surgery, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Heiss', 'Affiliation': 'Department of Radiology, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Lutter', 'Affiliation': 'Department of Orthopedic and Trauma Surgery, Sportsorthopedics and Sportsmedicine, Klinikum Bamberg, Bamberg, Germany.'}, {'ForeName': 'Matthias Wilhelm', 'Initials': 'MW', 'LastName': 'Hoppe', 'Affiliation': 'Department of Movement and Training Science, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Engelhardt', 'Affiliation': 'Department of Orthopedic, Trauma and Hand Surgery, Klinikum Osnabrück GmbH, Osnabrück, Germany.'}, {'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Grim', 'Affiliation': 'Department of Orthopedic, Trauma and Hand Surgery, Klinikum Osnabrück GmbH, Osnabrück, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Seehaus', 'Affiliation': 'Department of Orthopedic Surgery, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Raimund', 'Initials': 'R', 'LastName': 'Forst', 'Affiliation': 'Department of Orthopedic Surgery, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hotfiel', 'Affiliation': 'Department of Orthopedic Surgery, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.'}]",Sportverletzung Sportschaden : Organ der Gesellschaft fur Orthopadisch-Traumatologische Sportmedizin,['10.1055/a-0854-8302']
466,31379118,Efficacy and safety of magnesium isoglycyrrhizinate injection in patients with acute drug-induced liver injury: A phase II trial.,"BACKGROUND


Drug-induced liver injury (DILI) is the most common reason for a drug to be withdrawn from the market. Apart from stopping the offending drug, no regimens are available for treating idiosyncratic DILI in clinical practice.
METHODS


We carried out a randomized, double-blind, multidoses, active drug controlled, multicentre phase II trial to assess the safety and efficacy of the study drug, magnesium isoglycyrrhizinate (MgIG), as compared to tiopronin, a standard therapy for DILI in China. The primary outcome was the proportion of alanine aminotransferase (ALT) normalization at week 4 after study drug administration. Logistic regression was used to examine the odds of ALT normalization between low dose (Group A) and high dose (Group B) vs active control (Group C).
RESULTS


One hundred and seventy-four eligible subjects were randomized and enrolled into three groups: 59 in group A, 56 in group B and 59 in group C. It was shown that group A and group B lowered ALT level even at early stage of study drug administration; when compared with Group C (61.02%), the proportions of ALT normalization at week 4 were significantly greater in Group A (84.75%, P = .0029) and Group B (85.71%, P = .0037) respectively. The results from the univariate logistic model showed that the odds of ALT normalized among subjects in Group A were about 3.6 times greater (OR = 3.55, 95% CI: 1.47-8.57, P = .0049) than subjects in Group C. Similar effect was observed among subjects in Group B (OR = 3.83, 95% CI: 1.54-9.55, P = .0039).
CONCLUSIONS


This trial provided preliminary evidence that MgIG is an effective and safe treatment for patients with acute DILI.",2019,"It was shown that group A and group B lowered ALT level even at early stage of study drug administration; when compared with Group C (61.02%), the proportions of ALT normalization at week 4 were significantly greater in Group A (84.75%, P = .0029) and Group B (85.71%, P = .0037) respectively.","['One hundred and seventy-four eligible subjects', 'patients with acute drug-induced liver injury', 'DILI in China', 'patients with acute DILI']","['magnesium isoglycyrrhizinate injection', 'magnesium isoglycyrrhizinate (MgIG', 'MgIG']","['proportion of alanine aminotransferase (ALT) normalization', 'ALT level', 'proportions of ALT normalization', 'Efficacy and safety', 'safety and efficacy']","[{'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0860207', 'cui_str': 'Drug-Induced Liver Injury'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C1958566', 'cui_str': 'magnesium isoglycyrrhizinate'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",174.0,0.243078,"It was shown that group A and group B lowered ALT level even at early stage of study drug administration; when compared with Group C (61.02%), the proportions of ALT normalization at week 4 were significantly greater in Group A (84.75%, P = .0029) and Group B (85.71%, P = .0037) respectively.","[{'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Zhenghua', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Mengqiu', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': 'Division of Tuberculosis, Beijing Chest Hospital, Beijing, China.'}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Division of Tumor, Zhejiang Provincial Tumor Hospital, Hangzhou, China.'}, {'ForeName': 'Chengwei', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Liver Disease Center of Naval 905 Hospital, Shanghai, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': ""Division of Tumor, Shanghai Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Zhongshun', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Division of Tuberculosis, Shanghai Pulmonary Hospital, Shanghai, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Division of Tuberculosis, Nanjing Chest Hospital, Nanjing, China.'}, {'ForeName': 'Fujian', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Division of Tuberculosis, Zhejiang Hospital of Integrated Traditional Chinese and Western Medicine, Hangzhou, China.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Unimed Scientific Inc., Wuxi, China.'}, {'ForeName': 'Hong-Mei', 'Initials': 'HM', 'LastName': 'Gu', 'Affiliation': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd, Nanjing, China.'}, {'ForeName': 'Yingxuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jieting', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Minde', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14204']
467,31319786,Impact of a tobacco cessation intervention on adherence to tobacco use treatment guidelines among village health workers in Vietnam.,"Community health workers (in Vietnam referred to as village health workers) have the potential to play a key role in expanding access to evidence-based tobacco use treatment. We conducted a cluster randomized controlled trial in community health centers in Vietnam that compared the effect of provider advice and cessation assistance (i.e. brief counseling and patient education materials) (BC) vs. BC + three sessions of in-person counseling delivered by a village health worker (BC+R) on providers' and village health workers' adherence to tobacco use treatment guidelines. All village health workers and health care providers received training. This paper presents data on the effect of the intervention on village health workers' adherence to tobacco use treatment guidelines, including asking about tobacco use, advising smokers to quit, offering assistance and their attitude, norms, and self-efficacy related to tobacco use treatment. We examined changes in adherence to tobacco use treatment guidelines before and 12 months after the intervention among 89 village health workers working in the 13 community health centers enrolled in the BC+R study condition. Village health workers' adherence to tobacco use treatment guidelines increased significantly. Village health workers were more likely to ask about tobacco use (3.4% at baseline, 32.6% at 12 months), offer advice to quit (4.5% to 48.3%) and offer assistance (1.1% to 38.2%). Perceived barriers to treating tobacco use decreased significantly. Self-efficacy and attitudes towards treating tobacco use improved significantly. Increased adherence to tobacco use treatment guidelines was associated with positive attitudes towards their role in delivering tobacco use treatment and increasing awareness of the community health center smoke-free policy. The findings suggest that, with training and support systems, village health workers can extend their role to include smoking cessation services. This workforce could represent a sustainable resource for supporting smokers who wish to quit.",2020,Increased adherence to tobacco use treatment guidelines was associated with positive attitudes towards their role in delivering tobacco use treatment and increasing awareness of the community health center smoke-free policy.,"['village health workers', 'Village health workers', 'Community health workers (in Vietnam referred to as village health workers', 'All village health workers and health care providers', 'community health centers in Vietnam', 'village health workers in Vietnam', '89 village health workers working in the 13 community health centers enrolled in the BC+R study condition']","['tobacco cessation intervention', 'provider advice and cessation assistance (i.e. brief counseling and patient education materials) (BC) vs. BC + three sessions of in-person counseling delivered by a village health worker (BC+R']","['Self-efficacy and attitudes towards treating tobacco', 'advice to quit']","[{'cui': 'C0087157', 'cui_str': 'Village Health Workers'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0087157', 'cui_str': 'Village Health Workers'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to (procedure)'}]",,0.0448543,Increased adherence to tobacco use treatment guidelines was associated with positive attitudes towards their role in delivering tobacco use treatment and increasing awareness of the community health center smoke-free policy.,"[{'ForeName': 'Nam', 'Initials': 'N', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Social Medical Studies, Hanoi, Vietnam.'}, {'ForeName': 'Trang', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Social Medical Studies, Hanoi, Vietnam.'}, {'ForeName': 'Van', 'Initials': 'V', 'LastName': 'Truong', 'Affiliation': 'Institute of Social Medical Studies, Hanoi, Vietnam.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dang', 'Affiliation': 'Institute of Social Medical Studies, Hanoi, Vietnam.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Siman', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shelley', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY, USA.'}]",Global health promotion,['10.1177/1757975919854032']
468,31317828,A pilot study of the effects of running training on visuospatial memory in MS: A stronger functional embedding of the hippocampus in the default-mode network?,"BACKGROUND/OBJECTIVE


Endurance exercise can improve memory function in persons with multiple sclerosis (pwMS), but the effects on hippocampal functioning are currently unknown. We investigated the effects of a running intervention on memory and hippocampal functional connectivity in pwMS.
METHODS/RESULTS


Memory and resting-state functional magnetic resonance imaging (fMRI) data were collected in a running intervention ( n  = 15) and waitlist group ( n  = 14). Visuospatial memory improvement was correlated to increased connectivity between the hippocampus and the default-mode network (DMN) in the intervention group only.
CONCLUSION


As a result of endurance exercise, improvements in visuospatial memory may be mediated by a stronger functional embedding of the hippocampus in the DMN.",2020,"Visuospatial memory improvement was correlated to increased connectivity between the hippocampus and the default-mode network (DMN) in the intervention group only.
","['persons with multiple sclerosis (pwMS', 'MS']","['running training', 'running intervention', 'Endurance exercise']","['Visuospatial memory improvement', 'memory function', 'memory and hippocampal functional connectivity', 'visuospatial memory']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.0389327,"Visuospatial memory improvement was correlated to increased connectivity between the hippocampus and the default-mode network (DMN) in the intervention group only.
","[{'ForeName': 'Marijn', 'Initials': 'M', 'LastName': 'Huiskamp', 'Affiliation': 'Department of Anatomy & Neurosciences, MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Lousin', 'Initials': 'L', 'LastName': 'Moumdjian', 'Affiliation': 'REVAL Rehabilitation Research Center, BIOMED, Faculty of Rehabilitation Sciences, Hasselt University, Hasselt, Belgium; Institute of Psychoacoustics and Electronic Music (IPEM), Faculty of Arts and Philosophy, Gent University, Gent, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'van Asch', 'Affiliation': 'Fit up Physiotherapy Center, Kontich, Belgium.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Popescu', 'Affiliation': 'REVAL Rehabilitation Research Center, BIOMED, Faculty of Rehabilitation Sciences, Hasselt University, Hasselt, Belgium; Rehabilitation and MS Centre Overpelt, Overpelt, Belgium.'}, {'ForeName': 'Menno Michiel', 'Initials': 'MM', 'LastName': 'Schoonheim', 'Affiliation': 'Department of Anatomy & Neurosciences, MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Martijn D', 'Initials': 'MD', 'LastName': 'Steenwijk', 'Affiliation': 'Department of Anatomy & Neurosciences, MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Vanzeir', 'Affiliation': 'REVAL Rehabilitation Research Center, BIOMED, Faculty of Rehabilitation Sciences, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'van Wijmeersch', 'Affiliation': 'REVAL Rehabilitation Research Center, BIOMED, Faculty of Rehabilitation Sciences, Hasselt University, Hasselt, Belgium; Rehabilitation and MS Centre Overpelt, Overpelt, Belgium.'}, {'ForeName': 'Jeroen Jg', 'Initials': 'JJ', 'LastName': 'Geurts', 'Affiliation': 'Department of Anatomy & Neurosciences, MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Feys', 'Affiliation': 'REVAL Rehabilitation Research Center, BIOMED, Faculty of Rehabilitation Sciences, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Hanneke E', 'Initials': 'HE', 'LastName': 'Hulst', 'Affiliation': 'Department of Anatomy & Neurosciences, MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519863644']
469,31566744,Cryosurgical ablation for treatment of rhinitis: A prospective multicenter study.,"OBJECTIVE


To assess the efficacy and safety of cryoablation of the posterior nasal nerve (PNN) for treatment of chronic rhinitis.
METHODS


This was a prospective single-arm trial of 98 adult patients at six U.S. centers with chronic allergic and nonallergic rhinitis. PNN cryoablation was performed in-office under local anesthesia using a handheld device. Patients discontinued use of intranasal ipratropium 3 days prior to treatment and throughout the study period. Reflective Total Nasal Symptom Score (rTNSS) was measured at pretreatment baseline and posttreatment at 1 month, 3 months, 6 months, and 9 months. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was completed at pretreatment and 3 months posttreatment. Adverse effects and postprocedure medication usage were recorded.
RESULTS


Ninety-eight procedures (100%) were successfully completed. rTNSS significantly improved over pretreatment baseline (6.1 ± 1.9) at 1 month (2.9 ± 1.9, P < 0.001), 3 months (3.0 ± 2.3, P < 0.001), 6 months (3.0 ± 2.1, P < 0.001), and 9 months (3.0 ± 2.4, P < 0.001) postprocedure. Nasal congestion and rhinorrhea subscores improved significantly at all time points (P < 0.001). Both allergic and nonallergic rhinitis subcohorts showed improvement (P < 0.001), with a comparable degree of improvement between groups. RQLQ significantly improved over pretreatment baseline (3.0 ± 1.0) at 3 months (1.5 ± 1.0, P < 0.001), and all RQLQ subdomains demonstrated improvement. Of 54 patients using intranasal medication at baseline, 19 (35.2%) were able to discontinue use. Twenty-nine adverse effects were reported, including headache, epistaxis, and sinusitis.
CONCLUSION


Cryoablation of the PNN for chronic rhinitis is safe and can result in relief of nasal symptoms and improvements in quality of life.
LEVEL OF EVIDENCE


4 Laryngoscope, 130: 1877-1884, 2020.",2020,"Both allergic and nonallergic rhinitis subcohorts showed improvement (P < 0.001), with a comparable degree of improvement between groups.","['98 adult patients at six U.S. centers with chronic allergic and nonallergic rhinitis', 'rhinitis', '54 patients using intranasal medication at baseline, 19 (35.2%) were able to discontinue use', 'Ninety-eight procedures (100%) were successfully completed']","['posterior nasal nerve (PNN', 'intranasal ipratropium', 'PNN cryoablation', 'Cryosurgical ablation']","['Reflective Total Nasal Symptom Score (rTNSS', 'quality of life', 'efficacy and safety', 'headache, epistaxis, and sinusitis', 'rTNSS', 'RQLQ', 'Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ', 'Nasal congestion and rhinorrhea subscores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0027235', 'cui_str': 'Ipratropium'}, {'cui': 'C0010408', 'cui_str': 'Cryoablation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0231918', 'cui_str': 'Nasal symptom'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0014591', 'cui_str': 'Nosebleed'}, {'cui': 'C0037199', 'cui_str': 'Sinus Infections'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion (finding)'}, {'cui': 'C1260880', 'cui_str': 'Nasal catarrh'}]",98.0,0.0455949,"Both allergic and nonallergic rhinitis subcohorts showed improvement (P < 0.001), with a comparable degree of improvement between groups.","[{'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Chang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, U.S.A.'}, {'ForeName': 'Sunhee', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, U.S.A.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Hwang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, U.S.A.'}]",The Laryngoscope,['10.1002/lary.28301']
470,31309699,The Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial: baseline characteristics.,"BACKGROUND


The aims of this study were to: (i) report the baseline characteristics of patients enrolled in the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial, (ii) compare DAPA-HF patients to participants in contemporary heart failure (HF) registries and in other recent HF trials, and (iii) compare individuals with diabetes, pre-diabetes and a normal glycated haemoglobin (HbA1c) in DAPA-HF.
METHODS AND RESULTS


Adults with HF in New York Heart Association functional class ≥ II, a left ventricular ejection fraction ≤ 40%, an elevated N-terminal pro-B-type natriuretic peptide concentration and receiving standard treatment were eligible for DAPA-HF, which is comparing dapagliflozin 10 mg once daily to matching placebo. In patients without a history of diabetes, previously undiagnosed diabetes was defined as a confirmed HbA1c ≥ 6.5%. Among patients without known or undiagnosed diabetes, pre-diabetes was defined as a HbA1c ≥ 5.7% The remainder of patients, with a HbA1c < 5.7%, were defined as normoglycaemic. Of the 4744 patients (mean age 66 years; 23% women) randomized, 42% had known diabetes and 3% undiagnosed diabetes. Of the remainder, 67% had pre-diabetes and 33% normal HbA1c. Overall, DAPA-HF patients were generally similar to those in recent registries and in relevant trials and had high levels of background therapy: 94% angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitor, 96% beta-blocker, and 71% mineralocorticoid receptor antagonist; 26% had a defibrillator. Patients with diabetes had worse HF status, more co-morbidity, and greater renal impairment but received similar HF therapy. Patients with diabetes received non-insulin hypoglycaemic therapy alone in 49%, insulin alone in 11%, both in 14%, and none in 26%.
CONCLUSIONS


Patients randomized in DAPA-HF were similar to those in other contemporary HF with reduced ejection fraction (HFrEF) registries and trials. These patients were receiving recommended HFrEF therapy and those with diabetes were also treated with conventional glucose-lowering therapy. Consequently, DAPA-HF will test the incremental efficacy and safety of dapagliflozin in HFrEF patients with and without diabetes.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT03036124.",2019,"Patients with diabetes had worse HF status, more co-morbidity, and greater renal impairment but received similar HF therapy.","['Adults with HF in New York Heart Association functional class ≥\u2009II, a left ventricular ejection fraction ≤\u200940%, an elevated N-terminal pro-B-type natriuretic peptide concentration and receiving standard treatment were eligible for DAPA-HF, which is comparing dapagliflozin 10', 'HFrEF patients with and without diabetes', 'patients to participants in contemporary heart failure (HF) registries and in other recent HF trials, and (iii) compare individuals with diabetes, pre-diabetes and a normal glycated haemoglobin (HbA1c) in DAPA-HF', 'patients enrolled in the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial', '4774 patients (mean age 66\u2009years; 23% women) randomized, 42% had known diabetes and 3% undiagnosed diabetes', 'Patients with diabetes received non']","['insulin alone', 'placebo', 'insulin hypoglycaemic therapy', 'angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitor', 'dapagliflozin', 'DAPA-HF', 'HFrEF therapy', 'conventional glucose-lowering therapy']","['co-morbidity', 'renal impairment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}, {'cui': 'C0025250', 'cui_str': 'CALLA Antigen'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}]",4774.0,0.157524,"Patients with diabetes had worse HF status, more co-morbidity, and greater renal impairment but received similar HF therapy.","[{'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'National University of Cordoba, Cordoba, Argentina.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1548']
471,31093662,Relationship between degree of heparin anticoagulation and clinical outcome in patients receiving potent P2Y12-inhibitors with no planned glycoprotein IIb/IIIa inhibitor during percutaneous coronary intervention in acute myocardial infarction: a VALIDATE-SWEDEHEART substudy.,"AIMS


Heparin is the preferred choice of anticoagulant in percutaneous coronary intervention (PCI) for acute myocardial infarction (MI). An established dosage of heparin has not yet been determined, but treatment may be optimized through monitoring of activated clotting time (ACT). The aim of this study was to determine the relationship between heparin dose or ACT with a composite outcome of death, MI, or bleeding using data from the registry-based, randomized, controlled, and open-label VALIDATE-SWEDEHEART trial, although patients were not randomized to heparin dose in this substudy.
METHODS AND RESULTS


Patients with MI undergoing PCI and receiving treatment with a potent P2Y12-inhibitor and anticoagulation with heparin, without the planned use of glycoprotein IIb/IIIa inhibitor (GPI), were enrolled in this substudy. The primary endpoint was a composite endpoint of death, MI, and bleeding at 30 days. The individual components and stent thrombosis were analysed separately. We divided patients into groups according to the initial dose of unfractionated heparin during PCI (<70 U/kg, 70-100 U/kg, and >100 U/kg) or ACT (ACT <250 s, 250-350 s, and >350 s) as well as investigating them as continuous variables in Cox proportional hazards models using univariable and multivariable analyses. No major differences were noted between heparin stratified in groups (P = 0.22) or heparin as a continuous variable in relation to the primary composite endpoint hazard ratio (HR) 1.0 confidence interval (CI) (0.99-1.01) for heparin dose/kg. No differences were found between ACT stratified in groups (P = 0.453) or ACT in seconds HR 1.0 CI (0.99-1.00) regarding the primary endpoint. The individual components of death, MI, major bleeding, and stent thrombosis were not significantly different across heparin doses or ACT levels either.
CONCLUSION


We found no association between heparin dose or ACT levels and death, MI bleeding complications, or stent thrombosis. Therefore, there is no strong support for a specific heparin dose or mandatory ACT monitoring in patients treated with potent P2Y12-inhibitors with no planned GPI.",2020,"The individual components of death, MI, major bleeding and stent thrombosis were not significantly different across heparin doses or ACT levels either.
","['patients receiving potent P2Y12-inhibitors with no planned GPI during primary percutaneous coronary intervention in acute myocardial infarction', 'Patients with MI undergoing PCI and receiving treatment with a potent P2Y12-inhibitor and anticoagulation with heparin, without the planned use of glycoprotein IIb/IIIa inhibitor (GPI', 'patients treated with potent P2Y12-inhibitors with no planned GPI']","['Heparin', 'heparin dose or ACT', 'heparin', 'heparin anticoagulation', 'unfractionated heparin', 'percutaneous coronary intervention (PCI', 'ACT (ACT']","['death, MI, major bleeding and stent thrombosis', 'ACT levels and death, MI bleeding complications or stent thrombosis', 'death, MI or bleeding', 'composite end point of death, MI and bleeding at 30 days']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.0952697,"The individual components of death, MI, major bleeding and stent thrombosis were not significantly different across heparin doses or ACT levels either.
","[{'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Sharma', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Rylance', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Karlsson', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Koul', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Venetsanos', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institutet, Danderyd University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Elmir', 'Initials': 'E', 'LastName': 'Omerovic', 'Affiliation': 'Department of Cardiology, Sahlgrenska Academy, Gothenburg, Sweden.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Fröbert', 'Affiliation': 'Department of Cardiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institutet, Danderyd University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences Cardiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.'}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvz015']
472,31570246,The Survival Benefit From the Addition of Radiation to Chemotherapy in Gastric Cancer Patients Following Surgical Resection.,"AIMS


The survival benefit of radiation therapy in gastric cancer patients who underwent curative resection remains contentious.
MATERIALS AND METHODS


Gastric cancer patients who underwent curative resection followed by adjuvant chemotherapy or chemoradiation therapy (CRT) between 2004 and 2014 were identified from the National Cancer Database. Survival analyses were carried out with the Kaplan-Meier method and the Cox regression model.
RESULTS


In total, 4347 patients were included in this study. Of these patients, 1185 patients received postoperative chemotherapy alone and 3162 patients received postoperative CRT. For all patients included in the analysis, patients who received CRT had significantly better overall survival than those who received chemotherapy alone (5-year overall survival: 54.8% versus 46.8%, P < 0.001). The survival benefit primarily occurred in patients with stage II (5-year overall survival: 58.7% versus 53.8%, P = 0.03), stage III (42.5% versus 30.3%, P < 0.001) and lymph node-positive (5-year overall survival: 52.2% versus 41.9%, P = 0.03) gastric cancer. Multivariable analysis confirmed the improvement in overall survival in patients who received postoperative CRT (hazard ratio = 0.78; 95% confidence interval, 0.661-0.926; P < 0.001) was independent of all known prognostic factors. For lymph node-positive patients with lymphovascular invasion (LVI), postoperative CRT significantly improved overall survival compared with chemotherapy alone (5-year overall survival: 49.0% versus 39.4%, P = 0.001). However, there was no survival difference between CRT and chemotherapy alone if lymph node-positive patients had no LVI (5-year overall survival: 54.5% versus 52.7%, P = 0.55).
CONCLUSION


The current study suggests that postoperative CRT provides a survival benefit in gastric cancer patients with concurrent lymph node-positive and LVI-positive disease. A randomised clinical trial may further evaluate the benefit of adjuvant CRT in this subgroup.",2020,"(5-year overall survival: 54.5% versus 52.7%, P = 0.55).
","['Gastric cancer patients who underwent curative resection followed by adjuvant chemotherapy or chemoradiation therapy (CRT) between 2004 and 2014 were identified from the National Cancer Database', '4347 patients were included in this study', 'gastric cancer patients with concurrent lymph node-positive and LVI-positive disease', 'Gastric Cancer Patients Following Surgical Resection', 'gastric cancer patients who underwent curative resection remains contentious']","['CRT', 'postoperative chemotherapy alone', 'radiation therapy', 'adjuvant CRT', 'chemotherapy', 'Radiation to Chemotherapy', 'postoperative CRT']","['LVI', 'Survival Benefit', 'survival benefit primarily', 'overall survival', 'lymph node-positive (5-year overall survival', 'survival benefit', 'survival difference']","[{'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",1185.0,0.63246,"(5-year overall survival: 54.5% versus 52.7%, P = 0.55).
","[{'ForeName': 'T S', 'Initials': 'TS', 'LastName': 'Yang', 'Affiliation': ""Department of General Surgery, Shanghai Tenth Peoples' Hospital, Tongji University, Shanghai, China.""}, {'ForeName': 'X F', 'Initials': 'XF', 'LastName': 'Wang', 'Affiliation': 'Gastric Cancer Center, Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fairweather', 'Affiliation': ""Division of Surgical Oncology, Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts, USA; Gastrointestinal Surgical Center, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts, USA.""}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Sun', 'Affiliation': 'Gastric Cancer Center, Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Mamon', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, Massachusetts, USA. Electronic address: hmamon@bwh.harvard.edu.""}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Wang', 'Affiliation': ""Division of Surgical Oncology, Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts, USA; Gastrointestinal Surgical Center, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts, USA. Electronic address: jwang39@bwh.harvard.edu.""}]",Clinical oncology (Royal College of Radiologists (Great Britain)),['10.1016/j.clon.2019.09.047']
473,31722024,Effect of Intranasal vs Intramuscular Naloxone on Opioid Overdose: A Randomized Clinical Trial.,"Importance


Previous unblinded clinical trials suggested that the intranasal route of naloxone hydrochloride was inferior to the widely used intramuscular route for the reversal of opioid overdose.
Objective


To test whether a dose of naloxone administered intranasally is as effective as the same dose of intramuscularly administered naloxone in reversing opioid overdose.
Design, Setting, and Participants


A double-blind, double-dummy randomized clinical trial was conducted at the Uniting Medically Supervised Injecting Centre in Sydney, Australia. Clients of the center were recruited to participate from February 1, 2012, to January 3, 2017. Eligible clients were aged 18 years or older with a history of injecting drug use (n = 197). Intention-to-treat analysis was performed for all participants who received both intranasal and intramuscular modes of treatment (active or placebo).
Interventions


Clients were randomized to receive 1 of 2 treatments: (1) intranasal administration of naloxone hydrochloride 800 μg per 1 mL and intramuscular administration of placebo 1 mL or (2) intramuscular administration of naloxone hydrochloride 800 μg per 1 mL and intranasal administration of placebo 1 mL.
Main Outcomes and Measures


The primary outcome measure was the need for a rescue dose of intramuscular naloxone hydrochloride (800 μg) 10 minutes after the initial treatment. Secondary outcome measures included time to adequate respiratory rate greater than or equal to 10 breaths per minute and time to Glasgow Coma Scale score greater than or equal to 13.
Results


A total of 197 clients (173 [87.8%] male; mean [SD] age, 34.0 [7.82] years) completed the trial, of whom 93 (47.2%) were randomized to intramuscular naloxone dose and 104 (52.8%) to intranasal naloxone dose. Clients randomized to intramuscular naloxone administration were less likely to require a rescue dose of naloxone compared with clients randomized to intranasal naloxone administration (8 [8.6%] vs 24 [23.1%]; odds ratio, 0.35; 95% CI, 0.15-0.66; P = .002). A 65% increase in hazard (hazard ratio, 1.65; 95% CI, 1.21-2.25; P = .002) for time to respiratory rate of at least 10 and an 81% increase in hazard (hazard ratio, 1.81; 95% CI, 1.28-2.56; P = .001) for time to Glasgow Coma Scale score of at least 13 were observed for the group receiving intranasal naloxone compared with the group receiving intramuscular naloxone. No major adverse events were reported for either group.
Conclusions and Relevance


This trial showed that intranasally administered naloxone in a supervised injecting facility can reverse opioid overdose but not as efficiently as intramuscularly administered naloxone can, findings that largely replicate those of previous unblinded clinical trials. These results suggest that determining the optimal dose and concentration of intranasal naloxone to respond to opioid overdose in real-world conditions is an international priority.
Trial Registration


anzctr.org.au Identifier: ACTRN12611000852954.",2019,"A 65% increase in hazard (hazard ratio, 1.65; 95% CI, 1.21-2.25; P = .002) for time to respiratory rate of at least 10 and an 81% increase in hazard (hazard ratio, 1.81; 95% CI, 1.28-2.56; P = .001) for time to Glasgow Coma Scale score of at least 13 were observed for the group receiving intranasal naloxone compared with the group receiving intramuscular naloxone.","['Eligible clients were aged 18 years or older with a history of injecting drug use (n\u2009=\u2009197', 'Clients of the center were recruited to participate from February 1, 2012, to January 3, 2017', 'A total of 197 clients (173 [87.8%] male; mean [SD] age, 34.0 [7.82] years) completed the trial, of whom 93 (47.2', 'Uniting Medically Supervised Injecting Centre in Sydney, Australia']","['anzctr.org.au Identifier', 'intranasal and intramuscular modes of treatment (active or placebo', 'placebo 1 mL.\nMain Outcomes and Measures', 'intramuscular naloxone', 'naloxone hydrochloride 800 μg per 1 mL and intramuscular administration of placebo 1 mL or (2) intramuscular administration of naloxone hydrochloride', 'naloxone', 'Intranasal vs Intramuscular Naloxone', 'intranasal naloxone', 'naloxone hydrochloride']","['Opioid Overdose', 'time to respiratory rate', 'time to Glasgow Coma Scale score', 'time to adequate respiratory rate greater than or equal to 10 breaths per minute and time to Glasgow Coma Scale score']","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0700549', 'cui_str': 'Naloxone Hydrochloride'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439386', 'cui_str': 'breaths per minute'}]",197.0,0.34555,"A 65% increase in hazard (hazard ratio, 1.65; 95% CI, 1.21-2.25; P = .002) for time to respiratory rate of at least 10 and an 81% increase in hazard (hazard ratio, 1.81; 95% CI, 1.28-2.56; P = .001) for time to Glasgow Coma Scale score of at least 13 were observed for the group receiving intranasal naloxone compared with the group receiving intramuscular naloxone.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dietze', 'Affiliation': 'Behaviours and Health Risks Program, Burnet Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Jauncey', 'Affiliation': 'Uniting Medically Supervised Injecting Centre, Kings Cross, New South Wales, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Salmon', 'Affiliation': 'Uniting Medically Supervised Injecting Centre, Kings Cross, New South Wales, Australia.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Biostatistics Unit, Faculty of Health, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Latimer', 'Affiliation': 'Uniting Medically Supervised Injecting Centre, Kings Cross, New South Wales, Australia.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'van Beek', 'Affiliation': 'South Eastern Sydney Local Health District, New South Wales, Australia.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'McGrath', 'Affiliation': 'Justice Health Forensic Mental Health Network, New South Wales Health, Randwick, New South Wales, Australia.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Kerr', 'Affiliation': 'Centre for Quality and Patient Safety, School of Nursing and Midwifery, Deakin University, Geelong, Australia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.14977']
474,31866839,A MEG Study of Acute Arbaclofen (STX-209) Administration.,"Several electrophysiological parameters, including the auditory evoked response component M50/M100 latencies and the phase synchrony of transient and steady-state gamma-band oscillations have been implicated as atypical (to various extents) in autism spectrum disorder (ASD). Furthermore, some hypotheses suggest that an underlying neurobiological mechanism for these observations might be atypical local circuit function indexed by atypical levels of inhibitory neurotransmitter, GABA. This study was a randomized, placebo-controlled, double-blind, escalating-dose, acute investigation conducted in 25 14-18 year-old adolescents with ASD. The study assessed the sensitivity of magnetoencephalography (MEG) and MEGAPRESS ""GABA"" magnetic resonance spectroscopy (MRS) to monitor dose-dependent acute effects, as well as seeking to define properties of the pre-drug ""baseline"" electrophysiological and GABA signatures that might predict responsiveness to the GABA-B agonist, arbaclofen (STX-209). Overall, GABA levels and gamma-band oscillatory activity showed no acute changes at either low (15 mg) or high (30 mg) dose. Evoked M50 response latency measures tended to shorten (normalize), but there was heterogeneity across the group in M50 latency response, with only a subset of participants ( n  = 6) showing significant M50 latency shortening, and only at the 15 mg dose. Findings thus suggest that MEG M50 latency measures show acute effects of arbaclofen administration in select individuals, perhaps reflecting effective target engagement. Whether these subjects have a greater trend towards clinical benefit remains to be established. Finally, findings also provide preliminary support for the use of objective electrophysiological measures upon which to base inclusion for optimal enrichment of populations to be included in full-scale clinical trials of arbaclofen.",2019,"Several electrophysiological parameters, including the auditory evoked response component M50/M100 latencies and the phase synchrony of transient and steady-state gamma-band oscillations have been implicated as atypical (to various extents) in autism spectrum disorder (ASD).","['25 14-18 year-old adolescents with ASD', 'autism spectrum disorder (ASD']","['placebo', 'magnetoencephalography (MEG) and MEGAPRESS ""GABA"" magnetic resonance spectroscopy (MRS']","['Overall, GABA levels and gamma-band oscillatory activity', 'Evoked M50 response latency measures']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C0016904', 'cui_str': 'gamma-Aminobutyric Acid'}, {'cui': 'C0024487', 'cui_str': 'MR Spectroscopy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0016904', 'cui_str': 'gamma-Aminobutyric Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.136331,"Several electrophysiological parameters, including the auditory evoked response component M50/M100 latencies and the phase synchrony of transient and steady-state gamma-band oscillations have been implicated as atypical (to various extents) in autism spectrum disorder (ASD).","[{'ForeName': 'Timothy P L', 'Initials': 'TPL', 'LastName': 'Roberts', 'Affiliation': ""Lurie Family Foundations MEG Imaging Center, Department of Radiology, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Bloy', 'Affiliation': ""Lurie Family Foundations MEG Imaging Center, Department of Radiology, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Blaskey', 'Affiliation': ""Lurie Family Foundations MEG Imaging Center, Department of Radiology, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Kuschner', 'Affiliation': ""Lurie Family Foundations MEG Imaging Center, Department of Radiology, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Gaetz', 'Affiliation': ""Lurie Family Foundations MEG Imaging Center, Department of Radiology, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Anwar', 'Affiliation': ""Lurie Family Foundations MEG Imaging Center, Department of Radiology, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Ku', 'Affiliation': ""Lurie Family Foundations MEG Imaging Center, Department of Radiology, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Dipiero', 'Affiliation': ""Lurie Family Foundations MEG Imaging Center, Department of Radiology, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': ""Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'J Christopher', 'Initials': 'JC', 'LastName': 'Edgar', 'Affiliation': ""Lurie Family Foundations MEG Imaging Center, Department of Radiology, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}]",Frontiers in integrative neuroscience,['10.3389/fnint.2019.00069']
475,31603582,Auricular acupuncture for adult tonsillectomy.,"OBJECTIVES


Adult tonsillectomy causes significant postoperative pain that can last over 14 days, but narcotic regimens only provide a modest reduction in pain. Auricular acupuncture has been demonstrated to improve pain with minimal complications. This study compared acupuncture versus control for pain, opioid consumption, nausea, and return of diet and activity following tonsillectomy.
METHODS


A prospective, single-blinded randomized controlled trial was performed on 134 adults undergoing tonsillectomy at a tertiary care teaching hospital. Each patient was randomized to receive either auricular (Battlefield protocol) acupuncture with auricular bandages or bandages alone while under general anesthesia. Subjects journaled daily postoperative pain, diet, activity, and opioid consumption, then returned to the clinic on postoperative day 14 for a final questionnaire and evaluation.
RESULTS


Ninety-nine patients completed the study with 50 patients in the acupuncture group and 49 patients in the control group. Pain scores for the acupuncture group following tonsillectomy were significantly lower than the control group on the day of surgery (2.9, 4.3; P = .01), but there was no statistically significant difference in pain thereafter. There was an equivalent level of postoperative narcotic usage, nausea, emesis, functional activity and diet between the two groups. The main complication following tonsillectomy was secondary hemorrhage and there was no significant difference between the two groups (20%, 10%; P = .13).
CONCLUSION


Auricular acupuncture provides increased pain relief on the day of surgery, an effect that seems to diminish after 24 hours.
LEVEL OF EVIDENCE


1b Laryngoscope, 130: 1907-1912, 2020.",2020,"Pain scores for the acupuncture group following tonsillectomy were significantly lower than the control group on the day of surgery (2.9, 4.3; P = .01), but there was no statistically significant difference in pain thereafter.","['134 adults undergoing tonsillectomy at a tertiary care teaching hospital', 'Ninety-nine patients completed the study with 50 patients in the acupuncture group and 49 patients in the control group', 'adult tonsillectomy']","['auricular (Battlefield protocol) acupuncture with auricular bandages or bandages alone while under general anesthesia', 'Auricular acupuncture', 'acupuncture']","['Subjects journaled daily postoperative pain, diet, activity, and opioid consumption', 'pain', 'pain with minimal complications', 'pain thereafter', 'postoperative narcotic usage, nausea, emesis, functional activity and diet', 'Pain scores', 'pain relief', 'pain, opioid consumption, nausea, and return of diet and activity']","[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage (procedure)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0752217', 'cui_str': 'Auricular Acupuncture'}]","[{'cui': 'C2316067', 'cui_str': 'Journaling (regime/therapy)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",99.0,0.193897,"Pain scores for the acupuncture group following tonsillectomy were significantly lower than the control group on the day of surgery (2.9, 4.3; P = .01), but there was no statistically significant difference in pain thereafter.","[{'ForeName': 'Anil N', 'Initials': 'AN', 'LastName': 'Shah', 'Affiliation': 'Department of Otolaryngology, Naval Hospital Bremerton, Bremerton, Washington, U.S.A.'}, {'ForeName': 'Chad B', 'Initials': 'CB', 'LastName': 'Moore', 'Affiliation': 'Nurse Anesthesia Program, Uniformed Services University of the Health Sciences, Bethesda, Maryland, U.S.A.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Brigger', 'Affiliation': 'Department of Otolaryngology, Naval Medical Center San Diego, San Diego, California, U.S.A.'}]",The Laryngoscope,['10.1002/lary.28338']
476,31900187,"The impact of palliative care on quality of life, anxiety, and depression in idiopathic pulmonary fibrosis: a randomized controlled pilot study.","BACKGROUND


Idiopathic pulmonary fibrosis (IPF) is a fatal disease that results in poor quality of life due to progressive respiratory symptoms, anxiety, and depression. Palliative care improves quality of life and survival in other progressive diseases. No randomized controlled trials have investigated the impact of palliative care on quality of life, anxiety, or depression in IPF.
METHODS


We conducted a randomized, controlled, pilot study to assess the feasibility of measuring the effect of a palliative care clinic referral on quality of life, anxiety, and depression in IPF. Patients were randomized to usual care (UC) or usual care + palliative care (UC + PC) with routine pulmonary follow up at 3 and 6 months. The UC + PC group received a minimum of one PC clinic visit. Primary outcome was change from baseline in quality of life, anxiety, and depression as measured by the St. George's Respiratory Questionnaire (SGRQ), the Hospital Anxiety and Depression Index (HADS), and the Patient Health Questionnaire (PHQ-9) at 6 months.
RESULTS


Twenty-two patients were randomized between September 2017 through July 2018; 11 to UC and 11 to UC + PC. There was no difference in the change in SGRQ score at 3 months or 6 months, however, the symptom score trended towards a significant worsening for UC + PC at both 3 and 6 months (mean change at 3 months for UC and UC + PC was - 7.8 and + 10.7, respectively, p = 0.066; mean change at 6 months for UC and UC + PC was - 6.0 and + 4.6, respectively, p = 0.055). There was no difference in the change in HADS anxiety or depression scores. There was a significant transient worsening in PHQ-9 scores for UC + PC at 3 months (UC: -1.6, UC + PC: + 0.9, p = 0.008); this effect did not persist at 6 months.
CONCLUSION


This pilot study demonstrated that a randomized controlled trial of palliative care in idiopathic pulmonary fibrosis patients is feasible. Receiving palliative care did not lead to improved quality of life, anxiety, or depression compared to usual care after 6 months. Patients in the UC + PC group trended towards worsening symptoms and a small but statistically significant transient worsening in depression. These findings should be interpreted with caution, and need to be evaluated in adequately powered clinical trials. NCT03981406, June 10, 2019, retrospectively registered.",2020,"Receiving palliative care did not lead to improved quality of life, anxiety, or depression compared to usual care after 6 months.","['idiopathic pulmonary fibrosis patients', 'Twenty-two patients were randomized between September 2017 through July 2018; 11 to UC and 11 to UC\u2009+\u2009PC', 'idiopathic pulmonary fibrosis', 'Idiopathic pulmonary fibrosis (IPF']","['palliative care clinic referral', 'Palliative care', 'palliative care', 'usual care (UC) or usual care + palliative care (UC\u2009+\u2009PC']","['quality of life and survival', 'quality of life, anxiety, or depression in IPF', ""quality of life, anxiety, and depression as measured by the St. George's Respiratory Questionnaire (SGRQ), the Hospital Anxiety and Depression Index (HADS), and the Patient Health Questionnaire (PHQ-9"", 'SGRQ score', 'worsening symptoms', 'depression', 'PHQ-9 scores', 'quality of life, anxiety, or depression', 'HADS anxiety or depression scores', 'quality of life, anxiety, and depression in IPF', 'quality of life, anxiety, and depression']","[{'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}]","[{'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}]","[{'cui': 'C0034380'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.120816,"Receiving palliative care did not lead to improved quality of life, anxiety, or depression compared to usual care after 6 months.","[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Janssen', 'Affiliation': 'University of Minnesota Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, MMC 276, 420 Delaware Street SE, Minneapolis, MN, 55455, USA. jans0233@umn.edu.'}, {'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Rosielle', 'Affiliation': 'University of Minnesota Palliative Care, MMC 603 Mayo, 8603A, 420 Delaware Street SE, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'University of Minnesota Biostatistical Design and Support Center, Clinical Translational Science Institute, Room 223, 1932D, 717 Delaware St SE, Minneapolis, MN, 55414, USA.'}, {'ForeName': 'Hyun Joo', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'University of Minnesota Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, MMC 276, 420 Delaware Street SE, Minneapolis, MN, 55455, USA.'}]",Respiratory research,['10.1186/s12931-019-1266-9']
477,29334547,Quality of life improvement in resource-limited settings after one year of second-line antiretroviral therapy use among adult men and women.,"OBJECTIVE


We evaluated improvement of quality of life (QoL) after 1 year of second-line antiretroviral therapy (ART) use in resource-limited settings (RLS) among adult men and women, comparing two randomized treatment arms.
DESIGN


The AIDS Clinical Trial Group A5273 was a randomized clinical trial of second-line ART comparing lopinavir/ritonavir (LPV/r) + raltegravir with LPV/r + nucleos(t)ide reverse transcriptase inhibitors (NRTIs) in participants failing a non-NRTI-containing regimen at 15 sites in nine RLS. Participants completed the AIDS Clinical Trial Group short-form-21 which has eight QoL domains with a standard score ranging from 0 (worst) to 100 (best).
METHODS


Differences in QoL by randomized arm, as well as by demographic and clinical variables, were evaluated by regression models for baseline and week 48 QoL scores fitted using the generalized estimating equations method.
RESULTS


A total of 512 individuals (49% men, median age 39 years) were included. A total of 512 and 492 participants had QoL assessments at baseline and week 48, respectively. QoL improved significantly from baseline to week 48 (P < 0.001 for all domains). There was no significant difference between treatment arms for any domain. Individuals with higher viral load and lower CD4 cell count at baseline had lower mean QoL at baseline but larger improvements such that mean QoL was similar at week 48.
CONCLUSION


Improvements in QoL were similar after starting second-line ART of LPV/r combined with either raltegravir or NRTIs in RLS. QoL scores at baseline were lower among participants with worse disease status prior to starting second-line, but after 1 year similar QoL scores were achieved.",2018,"Individuals with higher viral load and lower CD4 cell count at baseline had lower mean QoL at baseline but larger improvements such that mean QoL was similar at week 48.
","['A total of 512 and 492 participants had QoL assessments at baseline and week 48, respectively', 'adult men and women', '512 individuals (49% men, median age 39 years', 'participants failing a non-NRTI-containing regimen at 15 sites in nine RLS']","['lopinavir/ritonavir (LPV/r)\u200a+\u200araltegravir with LPV/r\u200a+\u200anucleos(t)ide reverse transcriptase inhibitors (NRTIs', 'second-line antiretroviral therapy (ART']","['mean QoL', 'CD4 cell count', 'QoL', 'quality of life (QoL', 'QoL scores']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir / Ritonavir'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0028621', 'cui_str': 'Nucleosides'}, {'cui': 'C4521921', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",512.0,0.367307,"Individuals with higher viral load and lower CD4 cell count at baseline had lower mean QoL at baseline but larger improvements such that mean QoL was similar at week 48.
","[{'ForeName': 'Thiago S', 'Initials': 'TS', 'LastName': 'Torres', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Harrison', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'La Rosa', 'Affiliation': 'Asociación Civil Impacta Salud y Educación, Lima, Peru.'}, {'ForeName': 'Sandra W', 'Initials': 'SW', 'LastName': 'Cardoso', 'Affiliation': 'LAPCLIN-AIDS, Instituto Nacional de Infectologia Evandro Chagas (INI), Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, Brazil.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'McNeil', 'Initials': 'M', 'LastName': 'Ngongondo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Some', 'Affiliation': 'AMPATH at Moi University Teaching Hospital, Eldoret, Kenya.'}, {'ForeName': 'Umesh G', 'Initials': 'UG', 'LastName': 'Lalloo', 'Affiliation': 'Durban Adult HIV CRS, Durban.'}, {'ForeName': 'Thando', 'Initials': 'T', 'LastName': 'Mwelase', 'Affiliation': 'Wits Health Consortium Department of Medicine, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Collier', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hughes', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000001738']
478,31305186,Guselkumab improves work productivity in patients with moderate-to-severe psoriasis with or without depression and anxiety: results from the VOYAGE 2 comparator study versus adalimumab.,"Purpose:  To evaluate the impact of guselkumab on work productivity, including absenteeism and presenteeism, in psoriasis patients with and without depression/anxiety. Methods:  VOYAGE 2 is a randomized, double-blind, placebo-controlled, and comparator-controlled, phase 3 trial that compared guselkumab with adalimumab in patients with moderate-to-severe psoriasis. Absenteeism was evaluated among patients who reported that their skin prevented work/study based on the Dermatology Life Quality Index (DLQI) work/study domain (score = 3) at baseline. Presenteeism was assessed by summarizing mean changes in four Work Limitations Questionnaire (WLQ) domain scores at week 24. Analyses were compared between treatments and stratified by depression/anxiety status at baseline. Results:  At week 24, 82.1% and 50.0% in the guselkumab and adalimumab groups, respectively, reported a DLQI work/study score = 0 (no effect of skin on work/study) ( p  < .001). Mean changes (improvements) were greater in guselkumab-treated versus adalimumab-treated patients in the work limitations domains of Physical Demands (-6.9 vs. -3.3,  p  < .05), Mental-Interpersonal (-6.3 vs. -3.2,  p  < .06), and Output Demands (-6.2 vs. -2.2,  p  < .05). Improvements were consistent in patients with and without depression/anxiety. Conclusions:  Psoriasis patients treated with guselkumab had significantly better improvements in absenteeism and presenteeism compared with those treated with adalimumab, regardless of depression/anxiety status.",2020,"Conclusions:  Psoriasis patients treated with guselkumab had significantly better improvements in absenteeism and presenteeism compared with those treated with adalimumab, regardless of depression/anxiety status.","['patients with moderate-to-severe psoriasis with or without depression and anxiety', 'psoriasis patients with and without depression/anxiety', 'patients with moderate-to-severe psoriasis']","['guselkumab with adalimumab', 'adalimumab', 'placebo', 'guselkumab', 'Guselkumab']","['Output Demands', 'absenteeism and presenteeism', 'Dermatology Life Quality Index (DLQI) work/study domain', 'Mental-Interpersonal', 'Absenteeism', 'Limitations Questionnaire (WLQ) domain scores', 'work productivity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",,0.0621237,"Conclusions:  Psoriasis patients treated with guselkumab had significantly better improvements in absenteeism and presenteeism compared with those treated with adalimumab, regardless of depression/anxiety status.","[{'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf and Skinflammation® Center, Hamburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Foley', 'Affiliation': ""St. Vincent's Hospital Melbourne and Skin & Cancer Foundation Inc, The University of Melbourne, Carlton, Australia.""}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Janssen Research and Development, LLC, Malvern/Horsham, PA, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'McElligott', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Muser', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Janssen Research and Development, LLC, Malvern/Horsham, PA, USA.'}, {'ForeName': 'April W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1628172']
479,31841156,Exploring Patients' Experiences of Internet-Based Self-Management Support for Low Back Pain in Primary Care.,"OBJECTIVE


We explored patients' experiences of using Internet-based self-management support for low back pain (LBP) in primary care, with and without physiotherapist telephone guidance.
DESIGN


Exploratory descriptive qualitative study using thematic analysis, nested within a randomized feasibility trial.
METHODS


Patients with LBP who participated in a feasibility trial of the SupportBack Internet intervention (ISRCTN: 31034004) were invited to take part in semistructured telephone interviews after the three-month intervention period (a convenience sample from within the trial population). Fifteen participants took part (age range = 36-87 years, 66.7% female, characteristics representative of the trial population). Data were analyzed thematically.
RESULTS


Analysis resulted in the development of six themes (subthemes in parentheses): Perceptions of SupportBack's design (Clarity and ease of use, Variety and range of information provided, Need for specificity and flexibility), Engaging with the SupportBack intervention, Promoting positive thought processes (Reassurance, Awareness of self-management), Managing behavior with SupportBack (Motivation and goal setting, Using activity as a pain management strategy, Preferences for walking or gentle back exercises), Feeling supported by telephone physiotherapists (Provision of reassurances and clarity, Physiotherapists are motivating), Severity and comorbidity as barriers (Preexisting condition or severity acting as a barrier, Less useful for mild low back pain).
CONCLUSIONS


The Internet intervention SupportBack appeared to feasibly support self-management of LBP. Reassurance and ongoing support to implement behavioral changes were central to reported benefits. The addition of physiotherapist telephone support further enhanced the patient experience and the potential utility of the intervention.",2020,The Internet intervention SupportBack appeared to feasibly support self-management of LBP.,"[""patients' experiences of using Internet-based self-management support for low back pain (LBP) in primary care, with and without physiotherapist telephone guidance"", 'Fifteen participants took part (age range = 36-87 years, 66.7% female, characteristics representative of the trial population', 'Patients with LBP who participated in a feasibility trial of the SupportBack Internet intervention (ISRCTN: 31034004) were invited to take part in semistructured telephone interviews after the three-month intervention period (a convenience sample from within the trial population', 'for Low Back Pain in Primary Care']","['Internet-Based Self-Management Support', 'physiotherapist telephone']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517843', 'cui_str': '66.7 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]",[],15.0,0.0816618,The Internet intervention SupportBack appeared to feasibly support self-management of LBP.,"[{'ForeName': 'Adam W A', 'Initials': 'AWA', 'LastName': 'Geraghty', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lisa C', 'Initials': 'LC', 'LastName': 'Roberts', 'Affiliation': 'School of Health Sciences, University of Southampton & University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Stanford', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Hill', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Institute for Primary Care and Health Sciences, Keele University, Newcastle, UK.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Yoganantham', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Institute for Primary Care and Health Sciences, Keele University, Newcastle, UK.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Hay', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Institute for Primary Care and Health Sciences, Keele University, Newcastle, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'School of Psychological Science, University of Bristol, Bristol, UK.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz312']
480,31837946,Genicular Artery Embolization for the Treatment of Knee Pain Secondary to Osteoarthritis.,"PURPOSE


To evaluate the efficacy and safety of embolization of hyperemic synovial tissue for the treatment of knee pain secondary to osteoarthritis (OA).
MATERIALS AND METHODS


Twenty patients with radiographic knee OA and moderate-to-severe pain refractory to conservative therapy were enrolled in a prospective, 2-site pilot study. Genicular artery embolization (GAE) was performed with 75- or 100-μm spherical particles. Patients were assessed with magnetic resonance imaging at baseline and at 1 month and with the Visual Analogue Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline and at 1, 3, and 6 months. Adverse events were recorded at all timepoints.
RESULTS


Embolization of at least 1 genicular artery was achieved in 20/20 (100%) patients. Mean VAS improved from 76 mm ± 14 at baseline to 29 mm ± 27 at 6-month follow-up (P < .01). Mean WOMAC score improved from 61 ± 12 at baseline to 29 ± 27 at 6-month follow-up (P < .01). Self-limiting skin discoloration occurred in 13/20 (65%) patients. Two of 20 (10%) patients developed plantar sensory paresthesia that resolved within 14 days.
CONCLUSIONS


GAE to treat knee pain secondary to OA can be performed safely and demonstrates potential efficacy. Further randomized comparative studies are needed to determine true treatment effect versus placebo effect.",2020,Mean WOMAC score improved from 61 ± 12 at baseline to 29 ± 27 at 6-month follow-up (P < .01).,"['Knee Pain Secondary to Osteoarthritis', 'Twenty patients with radiographic knee OA and moderate-to-severe pain refractory to conservative therapy', 'knee pain secondary to osteoarthritis (OA']","['placebo', 'Genicular artery embolization (GAE', 'Genicular Artery Embolization', 'GAE', 'embolization of hyperemic synovial tissue']","['Mean VAS', 'plantar sensory paresthesia', 'Adverse events', 'Self-limiting skin discoloration', 'Visual Analogue Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC', 'Mean WOMAC score']","[{'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0447108', 'cui_str': 'Structure of genicular artery'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0151907', 'cui_str': 'Discoloration of skin (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0231413,Mean WOMAC score improved from 61 ± 12 at baseline to 29 ± 27 at 6-month follow-up (P < .01).,"[{'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Bagla', 'Affiliation': 'Department of Vascular and Interventional Radiology, Vascular Institute of Virginia, 14085 Crown Court, Woodbridge, VA, 22913; Department of Radiology, University of North Carolina, Chapel Hill, Chapel Hill, North Carolina. Electronic address: Sandeep.bagla@gmail.com.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Piechowiak', 'Affiliation': 'Department of Vascular and Interventional Radiology, Vascular Institute of Virginia, 14085 Crown Court, Woodbridge, VA, 22913.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Hartman', 'Affiliation': 'Department of Radiology, University of North Carolina, Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Orlando', 'Affiliation': 'Department of Vascular and Interventional Radiology, Vascular Institute of Virginia, 14085 Crown Court, Woodbridge, VA, 22913.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Del Gaizo', 'Affiliation': 'Department of Orthopedics, University of North Carolina, Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Isaacson', 'Affiliation': 'Department of Radiology, University of North Carolina, Chapel Hill, Chapel Hill, North Carolina.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2019.09.018']
481,31912780,Glyceryl trinitrate to reduce the need for manual removal of retained placenta following vaginal delivery: the GOT-IT RCT.,"BACKGROUND


Retained placenta is associated with postpartum haemorrhage and can lead to significant maternal morbidity if untreated. The only effective treatment is the surgical procedure of manual removal of placenta, which is costly, requires skilled staff, requires an operative environment and is unpleasant for women. Small studies suggest that glyceryl trinitrate may be an effective medical alternative.
OBJECTIVE


To determine the clinical effectiveness and cost-effectiveness of sublingual glyceryl trinitrate spray compared with placebo in reducing the need for manual removal of placenta in women with retained placenta after vaginal delivery following the failure of current management.
DESIGN


A group-sequential randomised double-blind placebo-controlled trial with a cost-effectiveness analysis.
SETTING


There were 29 obstetric units in the UK involved in the study.
PARTICIPANTS


There were 1107 women (glyceryl trinitrate group,  n  = 543; placebo group,  n  = 564) randomised between October 2014 and July 2017.
INTERVENTIONS


Glyceryl trinitrate spray was administered to 541 women in the intervention group, and a placebo was administered to 563 women in the control group.
MAIN OUTCOME MEASURES


Four primary outcomes were defined: (1) clinical - the need for manual removal of placenta, (2) safety - measured blood loss, (3) patient sided - satisfaction with treatment and side effects and (4) economic - cost-effectiveness of both treatments using the UK NHS perspective. Secondary clinical outcomes included a > 15% decrease in haemoglobin level, time from randomisation to delivery of placenta in theatre, the need for earlier manual removal of placenta than planned, increase in heart rate or decrease in blood pressure, requirement for blood transfusion, requirement for general anaesthesia, maternal pyrexia, and sustained uterine relaxation requiring additional uterotonics.
RESULTS


No difference was observed between the glyceryl trinitrate group and the control group for the placenta remaining undelivered within 15 minutes of study treatment (93.3% vs. 92%; odds ratio 1.01, 95% confidence interval 0.98 to 1.04;  p  = 0.393). There was no difference in blood loss of > 1000 ml between the glyceryl trinitrate group and the control group (22.2% vs. 15.5%; odds ratio 1.14, 95% confidence interval 0.88 to 1.48;  p  = 0.314). Palpitations were more common in the glyceryl trinitrate group than in the control group after taking the study drug (9.8% vs. 4.0%; odds ratio 2.60, 95% confidence interval 1.40 to 4.84;  p  = 0.003). There was no difference in any other measures of patient satisfaction between the groups. There was no difference in costs to the health service between groups (mean difference £55.30, 95% confidence interval -£199.20 to £309.79). Secondary outcomes revealed that a fall in systolic or diastolic blood pressure, or an increase in heart rate, was more common in the glyceryl trinitrate group than in the control group (odds ratio 4.9, 95% confidence interval 3.7 to 6.4;  p  < 0.001). The need for a blood transfusion was also more common in the glyceryl trinitrate group than in the control group (odds ratio 1.53, 95% confidence interval 1.04 to 2.25;  p  = 0.033).
CONCLUSIONS


Glyceryl trinitrate spray did not increase the delivery of retained placenta within 15 minutes of administration when compared with the placebo, and was not cost-effective for medical management of retained placenta. More participants reported palpitations and required a blood transfusion in the glyceryl trinitrate group. Further research into alternative methods of medical management of retained placenta is required.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN88609453.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 70. See the NIHR Journals Library website for further project information.",2019,"There was no difference in costs to the health service between groups (mean difference £55.30, 95% confidence interval -£199.20 to £309.79).","['563 women in the control group', '1107 women (glyceryl trinitrate group,  n \u2009=\u2009543; placebo group,  n \u2009=\u2009564) randomised between October 2014 and July 2017', '29 obstetric units in the UK involved in the study', 'women with retained placenta after vaginal delivery following the failure of current management']","['glyceryl trinitrate', 'sublingual glyceryl trinitrate spray', 'placebo', 'Glyceryl trinitrate spray', 'Glyceryl trinitrate']","['delivery of retained placenta', 'costs to the health service', 'blood transfusion', 'manual removal of placenta, (2) safety - measured blood loss, (3) patient sided - satisfaction with treatment and side effects and (4) economic - cost-effectiveness', 'Palpitations', 'blood loss', 'haemoglobin level, time from randomisation to delivery of placenta in theatre, the need for earlier manual removal of placenta than planned, increase in heart rate or decrease in blood pressure, requirement for blood transfusion, requirement for general anaesthesia, maternal pyrexia, and sustained uterine relaxation requiring additional uterotonics', 'fall in systolic or diastolic blood pressure, or an increase in heart rate', 'patient satisfaction', 'manual removal of placenta']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032043', 'cui_str': 'Placentome'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}]","[{'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0032043', 'cui_str': 'Placentome'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0195755', 'cui_str': 'Manual removal of retained placenta (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0030252', 'cui_str': 'Palpitations (finding)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0404381', 'cui_str': 'Placental delivery procedure (procedure)'}, {'cui': 'C0475307', 'cui_str': 'Theatre (environment)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0574078', 'cui_str': 'Maternal pyrexia'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0241597', 'cui_str': 'Uterine relaxation'}, {'cui': 'C3653843', 'cui_str': 'Other uterotonics in ATC'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",1107.0,0.501515,"There was no difference in costs to the health service between groups (mean difference £55.30, 95% confidence interval -£199.20 to £309.79).","[{'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Denison', 'Affiliation': ""Tommy's Centre for Maternal and Fetal Health Research, Medical Research Council Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Kathryn F', 'Initials': 'KF', 'LastName': 'Carruthers', 'Affiliation': ""Tommy's Centre for Maternal and Fetal Health Research, Medical Research Council Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'McPherson', 'Affiliation': 'Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Scotland', 'Affiliation': 'Health Economics Research Unit, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Sheonagh', 'Initials': 'S', 'LastName': 'Brook-Smith', 'Affiliation': ""Simpson's Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Clarkson', 'Affiliation': ""Tommy's Centre for Maternal and Fetal Health Research, Medical Research Council Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Peace', 'Affiliation': ""Tommy's Centre for Maternal and Fetal Health Research, Medical Research Council Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Brewin', 'Affiliation': ""Tommy's, Nicholas House, London, UK.""}, {'ForeName': 'Gin Nie', 'Initials': 'GN', 'LastName': 'Chua', 'Affiliation': 'Health Economics Research Unit, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Hallowell', 'Affiliation': 'Ethox Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Norman', 'Affiliation': ""Tommy's Centre for Maternal and Fetal Health Research, Medical Research Council Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lawton', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit/Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23700']
482,31545507,"Long-term efficacy and safety of sonidegib in patients with advanced basal cell carcinoma: 42-month analysis of the phase II randomized, double-blind BOLT study.","BACKGROUND


Basal cell carcinomas (BCCs) exhibit aberrant activation of the hedgehog pathway. Sonidegib is a hedgehog pathway inhibitor approved for the treatment of locally advanced BCC (laBCC) and metastatic BCC (mBCC) based on primary results of the BOLT study [Basal Cell Carcinoma Outcomes with LDE225 (sonidegib) Treatment].
OBJECTIVES


This is the final 42-month analysis of the BOLT study, evaluating the efficacy and safety of sonidegib.
METHODS


Adults with no prior hedgehog pathway inhibitor therapy were randomized in a 1 : 2 ratio to sonidegib 200 mg or 800 mg once daily. Treatment continued for up to 42 months or until disease progression, unacceptable toxicity, death, study termination or withdrawal of consent. The primary efficacy end point was the objective response rate (ORR) by central review, assessed at baseline; weeks 5, 9 and 17; then subsequently every 8 or 12 weeks during years 1 or 2, respectively. Safety end points included adverse event monitoring and reporting.
RESULTS


The study enrolled 230 patients, 79 and 151 in the 200-mg and 800-mg groups, respectively, of whom 8% and 3.3% remained on treatment by the 42-month cutoff, respectively. The ORRs by central review were 56% [95% confidence interval (CI) 43-68] for laBCC and 8% (95% CI 0·2-36) for mBCC in the 200-mg group and 46·1% (95% CI 37·2-55·1) for laBCC and 17% (95% CI 5-39) for mBCC in the 800-mg group. No new safety concerns emerged.
CONCLUSIONS


Sonidegib demonstrated sustained efficacy and a manageable safety profile. The final BOLT results support sonidegib as a viable treatment option for laBCC and mBCC. What's already known about this topic? Basal cell carcinoma (BCC) is usually treatable with surgery or radiation therapy, but there are limited treatment options for patients with advanced BCC. Sonidegib, a hedgehog pathway inhibitor approved for the treatment of advanced BCC, demonstrated clinically relevant efficacy and manageable safety in prior analyses of the phase II randomized, double-blind BOLT study [Basal Cell Carcinoma Outcomes with LDE225 (sonidegib) Treatment]. What does this study add? This final 42-month analysis of BOLT is the longest follow-up available for a hedgehog pathway inhibitor. Clinically relevant efficacy results were sustained from prior analyses, with objective response rates by central review of the approved 200-mg daily dose of 56% in locally advanced BCC and 8% in metastatic BCC. No new safety concerns were raised. The results confirmed sonidegib as a viable long-term treatment option for patients with advanced BCC.",2020,"Sonidegib is a hedgehog pathway inhibitor approved for the treatment of locally advanced BCC (laBCC) and metastatic BCC (mBCC) based on primary results of the BOLT (Basal Cell Carcinoma Outcomes with LDE225 [sonidegib] Treatment) study.
","['Adults with no prior hedgehog pathway inhibitor therapy', 'patients with advanced basal cell carcinoma', 'The study enrolled 230 patients, 79 and 151 in the 200 mg and 800 mg groups, respectively, of whom 8% and 3% remained on treatment by the 42-month cutoff, respectively']","['sonidegib 200 mg or 800 mg once daily', 'sonidegib']","['adverse event monitoring and reporting', 'unacceptable toxicity, death, study termination, or withdrawal of consent', 'objective response rate (ORR) by central review']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1265465', 'cui_str': 'Subfamily Erinaceinae'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007117', 'cui_str': 'Epithelioma, Basal Cell'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C4047161', 'cui_str': 'sonidegib 200 MG'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C3886731', 'cui_str': 'sonidegib'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}]",230.0,0.123833,"Sonidegib is a hedgehog pathway inhibitor approved for the treatment of locally advanced BCC (laBCC) and metastatic BCC (mBCC) based on primary results of the BOLT (Basal Cell Carcinoma Outcomes with LDE225 [sonidegib] Treatment) study.
","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'Department of Dermatology, University of Zürich, Skin Cancer Center, University Hospital, Zürich, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guminksi', 'Affiliation': 'Department of Medical Oncology, Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Skin Cancer Center Hannover, Department of Dermatology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Lear', 'Affiliation': 'Manchester Academic Health Science Centre, Manchester University and Salford Royal NHS Trust, Manchester, U.K.'}, {'ForeName': 'K D', 'Initials': 'KD', 'LastName': 'Lewis', 'Affiliation': 'University of Colorado Cancer Center, Anschutz, Aurora, CO, U.S.A.'}, {'ForeName': 'A L S', 'Initials': 'ALS', 'LastName': 'Chang', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, CA, U.S.A.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Combemale', 'Affiliation': 'Department of Dermatology, Hôpitaux Universitaires de Lyon, Université de Lyon, Lyon, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dirix', 'Affiliation': 'Saint-Augustinus Hospital, Antwerp, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kaatz', 'Affiliation': 'Department of Dermatology, SRH Waldklinikum, Gera, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kudchadkar', 'Affiliation': 'Emory University, Atlanta, GA, U.S.A.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Loquai', 'Affiliation': 'Department of Dermatology, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Plummer', 'Affiliation': 'Northern Centre for Cancer Care, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, U.K.'}, {'ForeName': 'H-J', 'Initials': 'HJ', 'LastName': 'Schulze', 'Affiliation': 'Department of Dermatology, Fachklinik Hornheide, Münster, Germany.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Stratigos', 'Affiliation': 'First Department of Dermatology-Venereology, National and Kapodistrian University of Athens School of Medicine, Andreas Sygros Hospital for Skin and Venereal Diseases, Athens, Greece.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Trefzer', 'Affiliation': 'Department of Dermatology, University Hospital Charite, Berlin, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Squittieri', 'Affiliation': 'Sun Pharmaceutical Industries, Inc., Princeton, NJ, U.S.A.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Migden', 'Affiliation': 'Departments of Dermatology and Head and Neck Surgery, The University of Texas-MD Anderson Cancer Center, Houston, TX, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.18552']
483,31906840,"Vitamin D and Calcium Supplement Attenuate Bone Loss among HIVInfected Patients Receiving Tenofovir Disoproxil Fumarate/Emtricitabine/ Efavirenz: An Open-Label, Randomized Controlled Trial.","BACKGROUND


Antiretroviral therapy (ART), especially with tenofovir disoproxil fumarate (TDF), has been associated with accelerated bone turnover and leads to significant bone loss.
OBJECTIVE


We aimed to determine the effect of vitamin D2 and calcium on bone mineral density (BMD) in HIV-infected patients receiving TDF/emtricitabine (FTC)/efavirenz (EFV).
METHODS


A prospective, open-label, randomized controlled study was conducted. Eligible patients were ART naïve HIV individuals who initiated TDF/FTC/EFV. The study group received supplementation with vitamin D2 and calcium carbonate, whereas the control group was administered only ART. The primary outcome was the percentage change in total hip BMD at week 24 compared with baseline.
RESULTS


A total of 18 patients were randomized (9 in each group). The mean (standard deviation; SD) total hip BMD significantly decreased from baseline in both groups, from 0.96 (0.14) g/cm2 to 0.93 (0.13) g/cm2 in the study group (p = 0.006) and from 0.87 (0.11) g/cm2 to 0.84 (0.11) g/cm2 in the control group (p = 0.004). The mean (SD) lumbar spine BMD significantly decreased from baseline in both groups, from 1.00 (0.13) g/cm2 to 0.97 (0.13) g/cm2 (p = 0.004) in the study group and from 0.90 (0.09) g/cm3 to 0.86 (0.08) g/cm2 in the control group (p = 0.006). At week 24, the mean (SD) lumbar spine BMD was significantly greater in the study group than in the control group (p = 0.042). However, there were no significant differences in the percentage change of total hip, lumbar spine, and femoral neck BMD between both groups. No adverse events were reported. In conclusion, as early as 24 weeks after TDF initiation, a significant decline in BMD was detected.
CONCLUSION


Vitamin D2 and calcium supplements should be considered for HIV-infected patients receiving TDF/FTC/EFV in a resource-limited setting where there are limited ART options (Clinicaltrials. gov NCT0287643).",2020,"At week 24, the mean (SD) lumbar spine BMD was significantly greater in the study group than in the control group (p = 0.042).","['18 patients', 'HIV-infected patients receiving TDF/emtricitabine (FTC)/efavirenz (EFV', 'Eligible patients were ART naïve HIV individuals who initiated TDF/FTC/EFV', 'HIV-infected Patients Receiving']","['tenofovir disoproxil fumarate (TDF', 'Vitamin D and Calcium Supplement', 'Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz', 'supplementation with vitamin D2 and calcium carbonate', 'vitamin D2 and calcium', 'Vitamin D2 and calcium supplements']","['BMD', 'mean (standard deviation; SD) total hip BMD', 'mean (SD) lumbar spine BMD', 'percentage change of total hip, lumbar spine, and femoral neck BMD', 'bone mineral density (BMD', 'percentage change in total hip BMD', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3540037', 'cui_str': 'Calcium supplement (substance)'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0014695', 'cui_str': 'Ergocalciferol'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0746104,"At week 24, the mean (SD) lumbar spine BMD was significantly greater in the study group than in the control group (p = 0.042).","[{'ForeName': 'Patawee', 'Initials': 'P', 'LastName': 'Boontanondha', 'Affiliation': 'Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Hataikarn', 'Initials': 'H', 'LastName': 'Nimitphong', 'Affiliation': 'Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Suchawadee', 'Initials': 'S', 'LastName': 'Musikarat', 'Affiliation': 'Department of Diagnostic and Therapeutic Radiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Aschara', 'Initials': 'A', 'LastName': 'Ragkho', 'Affiliation': 'Department of Pathology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Sasisopin', 'Initials': 'S', 'LastName': 'Kiertiburanakul', 'Affiliation': 'Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}]",Current HIV research,['10.2174/1570162X18666200106150806']
484,31844950,Intra-articular steroid for adhesive capsulitis: does hydrodilatation give any additional benefit? A randomized control trial.,"OBJECTIVES


To assess the benefit offered by capsular hydrodilatation in addition to intra-articular steroid injections in cases of adhesive capsulitis, assess outcomes in diabetic patients with capsular hydrodilatation as compared to non-diabetics and correlate duration of symptoms with outcome based on the type of intervention given.
MATERIALS AND METHODS


This prospective double-blinded randomized control trial included patients presenting with clinical features of adhesive capsulitis with no evidence of rotator cuff pathology and randomized them into two groups-intra-articular steroid with hydrodilatation (distension group) and only intra-articular steroid (non-distension group) with intervention being performed as per the group allotted. Primary outcome measure was Shoulder Pain and Disability Index (SPADI) scores which were taken pre-intervention, at 1.5, 3 and 6 months post-intervention, which were assessed by generalized linear model statistics and Pearson correlation.
RESULTS


Although there was statistically significant drop in SPADI in both groups over time [F(1.9, 137.6) = 112.2; p < 0.001], mean difference in SPADI between the 2 groups was not statistically significant (1.53; CI:-3.7 to 6.8; p = 0.56). There was no significant difference between both groups among diabetics [F(1,38) = 0.04; p = 0.95] and no significant difference between diabetic and non-diabetic patients who received hydrodilatation [F(1.8, 60) = 2.26; p = 0.12]. There was no significant correlation between the reduction in SPADI scores and duration of symptoms in any subset of the study population.
CONCLUSION


Shoulder joint hydrodilatation offered no additional benefit compared to intra-articular steroid injections for shoulder adhesive capsulitis. Outcome for diabetics and non-diabetics were similar and there was no correlation between duration of symptoms and outcome.",2020,"CONCLUSION


Shoulder joint hydrodilatation offered no additional benefit compared to intra-articular steroid injections for shoulder adhesive capsulitis.","['diabetic patients with capsular hydrodilatation', 'patients presenting with clinical features of adhesive capsulitis with no evidence of rotator cuff pathology']",['intra-articular steroid with hydrodilatation (distension group) and only intra-articular steroid (non-distension group) with intervention being performed as per the group allotted'],"['SPADI scores and duration of symptoms', 'Shoulder Pain and Disability Index (SPADI) scores', 'SPADI', 'mean difference in SPADI']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205151', 'cui_str': 'Capsular (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0158300', 'cui_str': 'Adhesive Capsulitis'}, {'cui': 'C0332125', 'cui_str': 'No evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C3714614', 'cui_str': 'Distention'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts (observable entity)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0657331,"CONCLUSION


Shoulder joint hydrodilatation offered no additional benefit compared to intra-articular steroid injections for shoulder adhesive capsulitis.","[{'ForeName': 'Samir M', 'Initials': 'SM', 'LastName': 'Paruthikunnan', 'Affiliation': 'Department of Radio-diagnosis and Imaging, Kasturba Medical College, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India.'}, {'ForeName': 'Praveen N', 'Initials': 'PN', 'LastName': 'Shastry', 'Affiliation': 'Department of Radio-diagnosis and Imaging, Kasturba Medical College, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India.'}, {'ForeName': 'Rajagopal', 'Initials': 'R', 'LastName': 'Kadavigere', 'Affiliation': 'Department of Radio-diagnosis and Imaging, Kasturba Medical College, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India. rajarad@gmail.com.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Pandey', 'Affiliation': 'Department of Orthopedics, Kasturba Medical College, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India.'}, {'ForeName': 'Lakshmikanth Halegubbi', 'Initials': 'LH', 'LastName': 'Karegowda', 'Affiliation': 'Department of Radio-diagnosis and Imaging, Kasturba Medical College, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India.'}]",Skeletal radiology,['10.1007/s00256-019-03316-8']
485,31303367,The Comparison of Traditional Radial Access and Novel Distal Radial Access for Cardiac Catheterization.,"OBJECTIVES


The traditional radial access (TRA) has been used almost routinely in coronary interventions in our clinic. Recently, we have started to use distal radial artery point as distal radial access (DRA) more frequently. The aim of this study is to compare these techniques (DRA and TRA) in terms of their safety, feasibility, and effectiveness.
BACKGROUND


Recently, the distal transradial access novel techniques have started to be used in coronary interventions, such as the anatomical snuffbox (AS) and DRA.
METHODS


This prospective, randomized study was carried out in a single center. The patients were selected from the catheterization laboratory of Medicana Ankara Hospital, between October 2018 and December 2018. Consecutive patients with TRA (103 patients) and DRA (102 patients) were randomized for coronary intervention.
RESULTS


Successful catheterization was achieved in 99 of 103 (96.1%) patients in the TRA group and in 97 patients of 102 (95.1%) patients in the DRA group. The radial artery spasm was observed in 4 cases in TRA group, whereas no radial artery spasm was seen in DRA group (p < 0.0001). The transradial access time in the DRA group (46.85 ± 2.41 s) lasted longer than the TRA (36.66 ± 5.16 s, p = 0.008).In DRA, hemostasis seems quicker than TRA.
CONCLUSIONS


DRA is feasible and safe for coronary angiography and interventions like TRA. It can be used as an alternative technique.",2020,"RESULTS


Successful catheterization was achieved in 99 of 103 (96.1%) patients in the TRA group and in 97 patients of 102 (95.1%) patients in the DRA group.","['patients were selected from the catheterization laboratory of Medicana Ankara Hospital, between October 2018 and December 2018', 'Consecutive patients with TRA (103 patients) and DRA (102 patients', 'cardiac catheterization']","['traditional radial access (TRA', 'TRA', 'DRA', 'traditional radial access and novel distal radial access', 'techniques (DRA and TRA']","['transradial access time', 'radial artery spasm', 'safety, feasibility, and effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0018795', 'cui_str': 'Catheterization, Heart'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0037763', 'cui_str': 'Muscular Spasm'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",103.0,0.0243291,"RESULTS


Successful catheterization was achieved in 99 of 103 (96.1%) patients in the TRA group and in 97 patients of 102 (95.1%) patients in the DRA group.","[{'ForeName': 'Veli', 'Initials': 'V', 'LastName': 'Vefalı', 'Affiliation': 'Medicana International Hospital, Cardiology Clinic, Ankara, Turkey.'}, {'ForeName': 'Ersin', 'Initials': 'E', 'LastName': 'Sarıçam', 'Affiliation': 'Medicana International Hospital, Cardiology Clinic, Ankara, Turkey. Electronic address: saricamersin@yahoo.com.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2019.07.001']
486,31294581,"Beneficial, adverse, and spiraling health-promotion effects: Evidence from a longitudinal randomized controlled trial of working at sit-stand desks.","In a 6-month longitudinal randomized field experiment, we examined how using height-adjustable sit-stand desks could have beneficial, adverse, and spiraling effects on people's musculoskeletal and psychovegetative complaints, and on positive (vitality and vigilance) and negative psychological symptoms, namely, stressor uncontrollability (i.e., perceived uncontrollability of workload), psychological tension, and mental tiredness. A total of 127 employees in various, mostly sedentary, occupations were randomly assigned to either the intervention or the control group. Variables were assessed monthly for 6 months on a self-reported basis. Bayesian structural equation modeling showed that the intervention produced large inhibiting between-subjects effects for musculoskeletal problems in the neck, back, and shoulders (β ranged between -.26 and -.21). Within-subject analyses revealed that the intervention produced large inhibiting effect sizes for intensity (g = 3.06) and prevalence of musculoskeletal (g = 1.19) and psychovegetative complaints (g between 0.76 and 1.57). For negative psychological symptoms (i.e., psychological tension and mental tiredness), participants in the intervention group showed a steeper decrease than participants in the control group (g between 2.34 and 3.74). For positive indicators (i.e., vitality and vigilance), the intervention produced large promoting effects for participants in the intervention group compared with participants in the control group (g between 0.70 and 1.65). There was no change in stressor uncontrollability between the two groups. Finally, findings suggest that sit-stand desks can be effective in improving occupational health by weakening a downward-spiraling effect. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"Bayesian structural equation modeling showed that the intervention produced large inhibiting between-subjects effects for musculoskeletal problems in the neck, back, and shoulders (β ranged between -.26 and -.21).","['127 employees in various, mostly sedentary, occupations']",[],"['psychovegetative complaints', ""people's musculoskeletal and psychovegetative complaints, and on positive (vitality and vigilance) and negative psychological symptoms, namely, stressor uncontrollability (i.e., perceived uncontrollability of workload), psychological tension, and mental tiredness"", 'stressor uncontrollability', 'prevalence of musculoskeletal', 'negative psychological symptoms (i.e., psychological tension and mental tiredness', 'occupational health']","[{'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}]",[],"[{'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0079920', 'cui_str': 'Occupational Health'}]",127.0,0.059595,"Bayesian structural equation modeling showed that the intervention produced large inhibiting between-subjects effects for musculoskeletal problems in the neck, back, and shoulders (β ranged between -.26 and -.21).","[{'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Konradt', 'Affiliation': 'Department of Work and Organizational Psychology, and Institute of Psychology, Kiel University.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Heblich', 'Affiliation': 'Department of Work and Organizational Psychology, and Institute of Psychology, Kiel University.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Krys', 'Affiliation': 'Department of Work and Organizational Psychology, and Institute of Psychology, Kiel University.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Garbers', 'Affiliation': 'Department of Work and Organizational Psychology, and Institute of Psychology, Kiel University.'}, {'ForeName': 'Kai-Philip', 'Initials': 'KP', 'LastName': 'Otte', 'Affiliation': 'Department of Work and Organizational Psychology, and Institute of Psychology, Kiel University.'}]",Journal of occupational health psychology,['10.1037/ocp0000161']
487,31838113,Effect of Oxygen Therapy on Cardiovascular Outcomes in Relation to Baseline Oxygen Saturation.,"OBJECTIVES


The aim of this study was to determine the effect of supplemental oxygen in patients with myocardial infarction (MI) on the composite of all-cause death, rehospitalization with MI, or heart failure related to baseline oxygen saturation. A secondary objective was to investigate outcomes in patients developing hypoxemia.
BACKGROUND


In the DETO2X-AMI (Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction) trial, 6,629 normoxemic patients with suspected MI were randomized to oxygen at 6 l/min for 6 to 12 h or ambient air.
METHODS


The study population of 5,010 patients with confirmed MI was divided by baseline oxygen saturation into a low-normal (90% to 94%) and a high-normal (95% to 100%) cohort. Outcomes are reported within 1 year. To increase power, all follow-up time (between 1 and 4 years) was included post hoc, and interaction analyses were performed with oxygen saturation as a continuous covariate.
RESULTS


The composite endpoint of all-cause death, rehospitalization with MI, or heart failure occurred significantly more often in patients in the low-normal cohort (17.3%) compared with those in the high-normal cohort (9.5%) (p < 0.001), and most often in patients developing hypoxemia (23.6%). Oxygen therapy compared with ambient air was not associated with improved outcomes regardless of baseline oxygen saturation (interaction p values: composite endpoint, p = 0.79; all-cause death, p = 0.33; rehospitalization with MI, p = 0.86; hospitalization for heart failure, p = 0.35).
CONCLUSIONS


Irrespective of oxygen saturation at baseline, we found no clinically relevant beneficial effect of routine oxygen therapy in normoxemic patients with MI regarding cardiovascular outcomes. Low-normal baseline oxygen saturation or development of hypoxemia was identified as an independent marker of poor prognosis. (An Efficacy and Outcome Study of Supplemental Oxygen Treatment in Patients With Suspected Myocardial Infarction; NCT01787110).",2020,"Oxygen therapy compared with ambient air was not associated with improved outcomes regardless of baseline oxygen saturation (interaction p values: composite endpoint, p = 0.79; all-cause death, p = 0.33; rehospitalization with MI, p = 0.86; hospitalization for heart failure, p = 0.35).
","['patients with myocardial infarction (MI', '6,629 normoxemic patients with suspected MI', '5,010 patients with confirmed MI was divided by baseline oxygen saturation into a low-normal (90% to 94%) and a high-normal (95% to 100%) cohort', 'Patients With Suspected Myocardial Infarction', 'normoxemic patients with MI regarding cardiovascular outcomes', 'patients developing hypoxemia']","['Oxygen therapy', 'routine oxygen therapy', 'supplemental oxygen', 'Oxygen Therapy', 'Supplemental Oxygen Treatment']","['composite endpoint of all-cause death, rehospitalization with MI, or heart failure', 'Low-normal baseline oxygen saturation or development of hypoxemia', 'Cardiovascular Outcomes', 'baseline oxygen saturation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]",5010.0,0.112062,"Oxygen therapy compared with ambient air was not associated with improved outcomes regardless of baseline oxygen saturation (interaction p values: composite endpoint, p = 0.79; all-cause death, p = 0.33; rehospitalization with MI, p = 0.86; hospitalization for heart failure, p = 0.35).
","[{'ForeName': 'Stefan K', 'Initials': 'SK', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden; Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Clinical Sciences, Cardiology, Lund University, Lund, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Herlitz', 'Affiliation': 'Department of Health Sciences, University of Borås, Borås, Sweden.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Alfredsson', 'Affiliation': 'Department of Medical and Health Sciences and Department of Cardiology, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Koul', 'Affiliation': 'Department of Clinical Sciences, Cardiology, Lund University, Lund, Sweden.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Fröbert', 'Affiliation': 'Department of Cardiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kellerth', 'Affiliation': 'Department of Cardiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Annica', 'Initials': 'A', 'LastName': 'Ravn-Fischer', 'Affiliation': 'Department of Molecular and Clinical Medicine and Sahlgrenska University Hospital, Department of Cardiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Alström', 'Affiliation': 'Department of Clinical Science and Education, Division of Cardiology, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Ollie', 'Initials': 'O', 'LastName': 'Östlund', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Jernberg', 'Affiliation': 'Department of Clinical Sciences, Cardiology, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden.'}, {'ForeName': 'Bertil', 'Initials': 'B', 'LastName': 'Lindahl', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden; Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Hofmann', 'Affiliation': 'Department of Clinical Science and Education, Division of Cardiology, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden. Electronic address: robin.hofmann@sll.se.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.09.016']
488,31188268,"A randomised, double-blind, placebo-controlled crossover trial of the influence of the HCN channel blocker ivabradine in a healthy volunteer pain model: an enriched population trial.","Preclinical studies suggest that type 2 hyperpolarization-activated cyclic nucleotide gated ion channels (HCN2) are necessary for neuropathic pain. This trial assessed the influence of ivabradine, a nonselective HCN channel blocker, on capsaicin-induced hyperalgesia and pain in healthy human subjects. An enriched population comprising subjects who developed >20 cm of punctate hyperalgesia from topical capsaicin (0.5% cream applied onto 9 cm area) was identified. These subjects then received ivabradine (15 mg) or placebo 1 hour before capsaicin application in randomly allocated order in a crossover study. The forearm site for capsaicin alternated with each application of the cream. The interval of time from screening to the first and to the second treatment visits was at least 3 and 5 weeks, respectively, to minimize carryover effects. Fifty-five participants were screened, of which 25 completed at least 1 treatment visit. Intention-to-treat hierarchical analysis revealed no significant effects of the drug on primary trial outcome, defined as a difference in effects of placebo and ivabradine on the area of punctate hyperalgesia (ivabradine - placebo: mean = 3.22 cm, 95% confidence interval: = -4.04 to 10.48, P = 0.37). However, ivabradine caused a slowing of heart rate (difference of 10.10 beats per minute [95% confidence interval -6.48 to -13.73; P-value <0.0001]). We conclude that ivabradine lacks analgesic effects in the capsaicin pain model at a dose that caused appreciable slowing of heart rate and, hence, is unlikely to prove a useful analgesic in humans. More selective drugs are required to establish a role of HCN2 for pain in humans.",2019,"mean=3.22 cm2, 95% CI: = -4.04, 10.48, p=0.37).","['healthy human subjects', '55 participants were screened, of which 25 completed at least one treatment visit', 'healthy volunteer pain model']","['ivabradine', 'topical capsaicin', 'HCN channel blocker ivabradine', 'placebo', 'ivabradine, a non-selective HCN channel blocker', 'placebo and ivabradine', 'capsaicin application', 'capsaicin']","['slowing of heart rate', 'heart rate', 'hyperalgesia and pain']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",55.0,0.494916,"mean=3.22 cm2, 95% CI: = -4.04, 10.48, p=0.37).","[{'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': 'Division of Anaesthesia, Department of Medicine, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wheeler', 'Affiliation': 'Division of Anaesthesia, Department of Medicine, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Scholtes', 'Affiliation': 'Division of Anaesthesia, Department of Medicine, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Armstrong', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McNaughton', 'Affiliation': 'Wolfson Centre for Age-Related Diseases, Kings College London, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Menon', 'Affiliation': 'Division of Anaesthesia, Department of Medicine, University of Cambridge, Cambridge, United Kingdom.'}]",Pain,['10.1097/j.pain.0000000000001638']
489,31800360,Self-Perceived Improvement in Bladder Health After Viewing a Novel Tutorial on Knack Use: A Randomized Controlled Trial Pilot Study.,"Purpose:  To test a novel bladder health tutorial on use of the Knack for overcoming bladder control challenges. The Knack-tutorial is a self-administered vignette-based instructional program on preempting bladder challenges in daily life (urgency, stress-leakage, or urge-leakage) through anticipatory, well-timed pelvic floor muscle contraction at the moment of challenge.  Materials and Methods:  This is a randomized controlled trial pilot test of 108 women with stress or mixed urinary incontinence. The Knack-tutorial group saw a 15-minute slide show with 10 vignettes portraying use of the Knack in daily life. The slide show format used inserted narrated videos, dubbed and animation enhanced pictures and cartoons, and automatic slide advancement. A control group saw a similarly constructed slide show on incorporating good diet/exercise habits. Outcomes were self-perceived improvement (yes/no, and as 0%-100%) 1 month after viewing the tutorial.  Results:  We enrolled 123 women, randomizing 64 to Knack-tutorial group and 59 to diet/exercise tutorial group. Eleven and one participant, respectively, did not return. Three did not fill out the self-perceived improvement report. Significant improvement was reported by 71% in the Knack-tutorial group compared to 25% in the diet/exercise group ( p  < 0.001). Self-perceived improvement was 21%-22% higher (Model I Est: 21.01, SE: 4.25,  p  < 0.001) in the Knack-tutorial group.  Conclusions:  An electronic tutorial viewed independent of a health care provider with vignettes showing Knack application to manage the everyday bladder challenges women face shows benefit of a magnitude that warrants more widespread use and rigorous testing. A professional remake of the intervention is now available (www.myconfidentbladder.com).",2020,Significant improvement was reported by 71% in the Knack-tutorial group compared to 25% in the diet/exercise group ( p  < 0.001).,"['123 women, randomizing 64 to Knack-tutorial group and 59 to diet/exercise tutorial group', '108 women with stress or mixed urinary incontinence']",[],"['Self-Perceived Improvement in Bladder Health', 'Self-perceived improvement']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}]",[],"[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",123.0,0.0526011,Significant improvement was reported by 71% in the Knack-tutorial group compared to 25% in the diet/exercise group ( p  < 0.001).,"[{'ForeName': 'Janis M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Kieran M', 'Initials': 'KM', 'LastName': 'Hawthorne', 'Affiliation': 'Arbor Research Collaborative for Health, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Tolbert', 'Affiliation': 'Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Bies', 'Affiliation': 'Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Garcia', 'Affiliation': 'Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Misiunas', 'Affiliation': 'Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, Michigan, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Newhouse', 'Affiliation': 'Center for Health Communications Research, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Abigail R', 'Initials': 'AR', 'LastName': 'Smith', 'Affiliation': 'Arbor Research Collaborative for Health, Ann Arbor, Michigan, USA.'}]",Journal of women's health (2002),['10.1089/jwh.2018.7606']
490,31789965,Pulmonary levels of biomarkers for inflammation and lung injury in protective versus conventional one-lung ventilation for oesophagectomy: A randomised clinical trial.,"BACKGROUND


It is uncertain whether protective ventilation reduces ventilation-induced pulmonary inflammation and injury during one-lung ventilation.
OBJECTIVE


To compare intra-operative protective ventilation with conventional during oesophagectomy with respect to pulmonary levels of biomarkers for inflammation and lung injury.
DESIGN


Randomised clinical trial.
SETTING


Tertiary centre for oesophageal diseases.
PATIENTS


Twenty-nine patients scheduled for one-lung ventilation during oesophagectomy.
INTERVENTIONS


Low tidal volume (VT) of 6 ml kg predicted body weight (pbw) during two-lung ventilation and 3 ml kgpbw during one-lung ventilation with 5 cmH2O positive end expired pressure versus intermediate VT of 10 ml kgpbw during two-lung ventilation and 5 ml kgpbw body weight during one-lung ventilation with no positive end-expiratory pressure.
OUTCOME MEASURES


The primary outcome was the change in bronchoalveolar lavage (BAL) levels of preselected biomarkers for inflammation (TNF-α, IL-6 and IL-8) and lung injury (soluble Receptor for Advanced Glycation End-products, surfactant protein-D, Clara Cell protein 16 and Krebs von den Lungen 6), from start to end of ventilation.
RESULTS


Median [IQR] VT in the protective ventilation group (n = 13) was 6.0 [5.7 to 7.8] and 3.1 [3.0 to 3.6] ml kgpbw during two and one-lung ventilation; VT in the conventional ventilation group (n = 16) was 9.8 [7.0 to 10.1] and 5.2 [5.0 to 5.5] ml kgpbw during two and one-lung ventilation. BAL levels of biomarkers for inflammation increased from start to end of ventilation in both groups; levels of soluble Receptor for Advanced Glycation End-products, Clara Cell protein 16 and Krebs von den Lungen 6 did not change, while levels of surfactant protein-D decreased. Changes in BAL biomarkers levels were not significantly different between the two ventilation strategies.
CONCLUSION


Intra-operative protective ventilation compared with conventional ventilation does not affect changes in pulmonary levels of biomarkers for inflammation and lung injury in patients undergoing one-lung ventilation for oesophagectomy.
TRIAL REGISTRATION


The 'Low versus Conventional tidal volumes during one-lung ventilation for minimally invasive oesophagectomy trial' (LoCo) was registered at the Netherlands Trial Register (study identifier NTR 4391).",2020,"BAL levels of biomarkers for inflammation increased from start to end of ventilation in both groups; levels of soluble Receptor for Advanced Glycation End-products, Clara Cell protein 16 and Krebs von den Lungen 6 did not change, while levels of surfactant protein-D decreased.","['patients undergoing one-lung ventilation for oesophagectomy', 'oesophagectomy', 'Tertiary centre for oesophageal diseases', 'Twenty-nine patients scheduled for one-lung ventilation during oesophagectomy']","['ml\u200akg predicted body weight (pbw) during two-lung ventilation and 3\u200aml\u200akgpbw during one-lung ventilation with 5\u200acmH2O positive end expired pressure versus intermediate VT of 10\u200aml\u200akgpbw during two-lung ventilation and 5\u200aml\u200akgpbw body weight during one-lung ventilation with no positive end-expiratory pressure', 'conventional one-lung ventilation', 'protective ventilation', 'Intra-operative protective ventilation', 'conventional ventilation', 'Low tidal volume (VT) of 6']","['BAL levels of biomarkers for inflammation', 'change in bronchoalveolar lavage (BAL) levels of preselected biomarkers for inflammation (TNF-α, IL-6 and IL-8) and lung injury (soluble Receptor for Advanced Glycation End-products, surfactant protein-D, Clara Cell protein 16 and Krebs von den Lungen 6), from start to end of ventilation', 'BAL biomarkers levels', 'pulmonary levels of biomarkers for inflammation and lung injury']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0559312', 'cui_str': 'Single-Lung Ventilation'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0014852', 'cui_str': 'Esophageal Diseases'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0554804', 'cui_str': 'Ventilation assistance'}, {'cui': 'C0559312', 'cui_str': 'Single-Lung Ventilation'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}]","[{'cui': 'C0012383', 'cui_str': 'Dimercaprol'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1535502', 'cui_str': 'Lung Lavage'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0273115', 'cui_str': 'Pulmonary Injury'}, {'cui': 'C0101725', 'cui_str': 'Advanced Glycosylation Endproduct Receptors'}, {'cui': 'C3536958', 'cui_str': 'Surfactant protein D'}, {'cui': 'C3840487', 'cui_str': 'CC16 - Clara cell protein 16'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}]",29.0,0.0619296,"BAL levels of biomarkers for inflammation increased from start to end of ventilation in both groups; levels of soluble Receptor for Advanced Glycation End-products, Clara Cell protein 16 and Krebs von den Lungen 6 did not change, while levels of surfactant protein-D decreased.","[{'ForeName': 'Margaretha C', 'Initials': 'MC', 'LastName': 'van der Woude', 'Affiliation': 'From the Department of Intensive Care Medicine (MCvdW, LB, RPvdH), Department of Anaesthesiology (MCvdW), Department of Pulmonology (RPvdH), Department of Surgery, Zuyderland Medical Centre, Heerlen (MNS, HJB), Department of Anaesthesiology (SNH), Laboratory of Experimental Intensive Care and Anaesthesiology (L·E·I·C·A), Amsterdam University Medical Centres, Location AMC, Amsterdam, The Netherlands (ATB, MJS), Department of Anaesthesiology and Intensive Care, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Dresden, Germany (MGdA), Department of Surgical Sciences and Integrated Diagnostics (PP), San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, University of Genoa, Genoa, Italy (PP), Department of Intensive Care, Amsterdam University Medical Centres, Location AMC, Amsterdam (PES, ASN, MJS), Department of Intensive Care Medicine, Gelre Hospitals, Apeldoorn, The Netherlands (PES), Department of Critical Care Medicine, Hospital Israelita Albert Einstein (ASN), Pulmonary Division, Cardio-Pulmonary Department, Instituto do Coração, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil (ASN), Mahidol-Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand (MJS) and Nuffield Department of Medicine, University of Oxford, Oxford, UK (MJS).'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bormans', 'Affiliation': ''}, {'ForeName': 'Robrecht P', 'Initials': 'RP', 'LastName': 'van der Horst', 'Affiliation': ''}, {'ForeName': 'Meindert N', 'Initials': 'MN', 'LastName': 'Sosef', 'Affiliation': ''}, {'ForeName': 'Henricus J', 'Initials': 'HJ', 'LastName': 'Belgers', 'Affiliation': ''}, {'ForeName': 'Sabrine N', 'Initials': 'SN', 'LastName': 'Hemmes', 'Affiliation': ''}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Tuip-de Boer', 'Affiliation': ''}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Gama de Abreu', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': ''}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Spronk', 'Affiliation': ''}, {'ForeName': 'Ary Serpo', 'Initials': 'AS', 'LastName': 'Neto', 'Affiliation': ''}, {'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Schultz', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001126']
491,31259802,Improved Reduction of the Tibio-Fibular Syndesmosis with Tightrope compared to Screw Fixation: Results of a Randomized Controlled Study.,"OBJECTIVE


To compare the rate of malreduction following high fibular fractures associated with syndesmosis injury treated with open reduction and internal fixation, with either two screws or one knotless Tightrope device.
DESIGN


Prospective randomized controlled multicenter trial SETTING:: Eleven academic and community hospitals including level 1 and 2 trauma centers across CanadaPatients/Participants: One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability following malleolar bony fixation were followed for 12 months after treatment.
METHODS


Open reduction of the syndesmosis was performed in all cases. Fixation was randomized to either Tightrope (one knotless Tightrope, Group T) or screw fixation (two 3.5 mm cortical positional screws placed across 3 cortices, Group S). Surgical techniques and rehabilitation were standardized. All surgeons were trained or experienced in the use of the Tightrope device. Follow up was performed at 2 and 6 weeks, 3, 6 and 12 months.
MAIN OUTCOME MEASURE


Rate of malreduction based on bilateral ankle CT scan results at 3 months post fixation. Secondary outcome measures included adverse events, reoperation, and validated functional outcomes including the EQ5D, the Olerud-Molander Ankle Score (OM), the Foot and Ankle Disability Index (FADI), and the Work Productivity Activity Impairment Questionnaire (WPAI). The estimated sample size required to detect a difference in reduction rate was 72 patients, but the estimated sample size required to detect a difference in functional outcome scores was 240 patients, suggesting the study was adequately powered for radiographic results only.
RESULTS


Overall, the rate of malreduction using screw fixation was 39 % compared with 15 % using Tightrope fixation (p = 0.028, Chi square). Analysis of CT results was performed using a 2 mm translation or 10 degree rotation threshold for malreduction, and included fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, mid); medial compression; and rotation (fibular and articular). Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05). Group T syndesmoses also had greater diastasis compared to control limb (4.1 ± 1.3 vs 3.3 ± 1.4 mm, p<0.01) and less fibular medialization compared to Group S (1.04 ± 1.8 vs 0.3± 1.8 mm, p = 0.05). Functional outcome measures demonstrated significant improvements over time, but no differences between fixation groups. FADI scores at each time interval were: 44 ± 22 (T) vs 45 ± 24 (S) (6 weeks), 76 ± 14 vs 73 ± 17 (3 months), 89 ± 10 vs 86 ± 13 (6 months), and 93 ± 9 vs 90 ± 14 (12 months) (all p > 0.2). The reoperation rate was higher in the screw group compared to Tightrope (30% vs 4%, p= 0.02) with the difference driven by the rate of implant removal.
CONCLUSION


Based upon our results the Tightrope device appears to compare favorably to two, 3.5 mm, 3- cortex screw fixation for syndesmosis injuries.",2019,"Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05).","[' Eleven academic and community hospitals including level 1 and 2 trauma centers across CanadaPatients/Participants: One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability following malleolar bony fixation were followed for 12 months after treatment', 'syndesmosis injuries']","['Tightrope (one knotless Tightrope, Group T) or screw fixation', 'syndesmosis injury treated with open reduction and internal fixation, with either two screws or one knotless Tightrope device', 'Screw Fixation', '3- cortex screw fixation']","['rate of malreduction using screw fixation', 'Rate of malreduction based on bilateral ankle CT scan results at 3 months post fixation', 'greater anterior translation', 'fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, mid); medial compression; and rotation (fibular and articular', 'FADI scores', 'reoperation rate', 'adverse events, reoperation, and validated functional outcomes including the EQ5D, the Olerud-Molander Ankle Score (OM), the Foot and Ankle Disability Index (FADI), and the Work Productivity Activity Impairment Questionnaire (WPAI', 'rate of implant removal', 'fibular medialization']","[{'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0036679', 'cui_str': 'Separation (morphologic abnormality)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0443157', 'cui_str': 'Bony (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]","[{'cui': 'C0036669', 'cui_str': 'T-Groups'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0561946', 'cui_str': 'Removal of implant (procedure)'}]",103.0,0.107881,"Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanders', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-324, London, Ontario CANADA N6A 4G5 Tel: 519-685-8086 Fax: 519-685-8019.'}, {'ForeName': 'Prism', 'Initials': 'P', 'LastName': 'Schneider', 'Affiliation': 'Foothills Medical Centre McCaig Tower, 3134 Hospital Drive NW, Calgary, Alberta CANADA T2N 5A1 Tel: (403) 944-4518 Fax: (403) 270-8004.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-324, London, Ontario CANADA N6A 4G5 Tel: 519-685-8086 Fax: 519-685-8019.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Tieszer', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-414London, Ontario CANADA N6A 4G5 Tel: 519-685-8500 x 55362 Fax: 519-685-8059.'}, {'ForeName': 'Abdel-Rahman', 'Initials': 'AR', 'LastName': 'Lawendy', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-325, London, Ontario CANADA N6A 4G5 Tel: 519-685-8218 Fax: 519-685-8059 800 Commissioners Road East, Room E1-326 London, Ontario CANADA N6A 4G5 Tel: (519) 685-8086 Fax: (519) 685-8016 Email: david.sanders@lhsc.on.ca.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001559']
492,30734990,Aquablation for benign prostatic hyperplasia in large prostates (80-150 mL): 6-month results from the WATER II trial.,"OBJECTIVE


To present 6-month safety and effectiveness data from a multicentre prospective study of aquablation in men with lower urinary tract symptoms (LUTS) attributable to benign prostatic hyperplasia (BPH) with prostate volumes between 80 and 150 mL.
METHODS


Between September and December 2017, 101 men with LUTSattributable to BPHwere prospectively enrolled at 16 centres in Canada and the USA.
RESULTS


The mean prostate volume was 107 mL. The mean length of hospital stay after the aquablation procedure was 1.6 days (range: same day to 6 days). The primary safety endpoint (Clavien-Dindo grade 2 or higher or any grade 1 event resulting in persistent disability) at 3 months occurred in 45.5% of men, which met the study design goal of < 65% (P < 0.001). At 6 months, 22% of the patients had experienced a Clavien-Dindo grade 2, 14% a grade 3 and 5% a grade 4 adverse event. Bleeding complications requiring intervention and/or transfusion were recorded in eight patients prior to discharge and in six patients after discharge. The mean International Prostate Symptom Score improved from 23.2 ± 6.3 at baseline to 6.7 ± 5.1 at 3 months, meeting the study's primary efficacy endpoint goal (P < 0.001). The maximum urinary flow rate increased from 8.7 to 18.8 mL/s (P < 0.001) and post-void residual urine volume decreased from 131 at baseline to 47 at 6 months (P < 0.0001). At 6 months, prostate-specific antigen concentration reduced from 7.1 ± 5.9 ng/mL at baseline to 4.0 ± 3.9 ng/mL, a 44% reduction.
CONCLUSIONS


Aquablation is safe and effective in treating men with larger prostates (80-150 mL), without significant increase in procedure or resection time.",2019,"At 6 months, prostate-specific antigen concentration reduced from 7.1 ± 5.9 ng/mL at baseline to 4.0 ± 3.9 ng/mL, a 44% reduction.
","['men with lower urinary tract symptoms (LUTS) attributable to benign prostatic hyperplasia (BPH) with prostate volumes between 80 and 150 mL.\nMETHODS\n\n\nBetween September and December 2017, 101 men with LUTSattributable to BPHwere prospectively enrolled at 16 centres in Canada and the USA']",[],"['maximum urinary flow rate', 'post-void residual urine volume', 'primary safety endpoint (Clavien-Dindo grade 2 or higher or any grade 1 event resulting in persistent disability', 'mean prostate volume', 'mean length of hospital stay', 'procedure or resection time', 'mean International Prostate Symptom Score', 'prostate-specific antigen concentration', 'Bleeding complications']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]",[],"[{'cui': 'C0429783', 'cui_str': 'Urinary flow rate (observable entity)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0429774', 'cui_str': 'Residual urine volume (observable entity)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",101.0,0.0962217,"At 6 months, prostate-specific antigen concentration reduced from 7.1 ± 5.9 ng/mL at baseline to 4.0 ± 3.9 ng/mL, a 44% reduction.
","[{'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Institute of Urology, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Mo', 'Initials': 'M', 'LastName': 'Bidair', 'Affiliation': 'San Diego Clinical Trials, San Diego, CA, USA.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Zorn', 'Affiliation': 'University of Montreal Hospital Center, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Trainer', 'Affiliation': 'Adult Pediatric Urology and Urogynecology, P.C., Omaha, NE, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Arther', 'Affiliation': 'Adult Pediatric Urology and Urogynecology, P.C., Omaha, NE, USA.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Kramolowsky', 'Affiliation': 'Virginia Urology, Richmond, VA, USA.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Doumanian', 'Affiliation': 'Institute of Urology, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Elterman', 'Affiliation': 'University of Toronto - University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Kaufman', 'Affiliation': 'Albany Medical College, Albany, NY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lingeman', 'Affiliation': 'Indiana University Health Physicians, Indianapolis, IN, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Krambeck', 'Affiliation': 'Indiana University Health Physicians, Indianapolis, IN, USA.'}, {'ForeName': 'Gregg', 'Initials': 'G', 'LastName': 'Eure', 'Affiliation': 'Urology of Virginia, Virginia Beach, VA, USA.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Badlani', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Plante', 'Affiliation': 'University of Vermont Medical Center, Burlington, VT, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Uchio', 'Affiliation': 'VA Long Beach Healthcare System, Long Beach, CA, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Gin', 'Affiliation': 'VA Long Beach Healthcare System, Long Beach, CA, USA.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Goldenberg', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Paterson', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'So', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Humphreys', 'Affiliation': 'Mayo Clinic Arizona, Scottsdale, AZ, USA.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Roehrborn', 'Affiliation': 'UT Southwestern Medical Center, Department of Urology, University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kaplan', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Motola', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Naeem', 'Initials': 'N', 'LastName': 'Bhojani', 'Affiliation': 'University of Montreal Hospital Center, Université de Montréal, Montreal, QC, Canada.'}]",BJU international,['10.1111/bju.14703']
493,31648845,Patients with pulmonary arterial hypertension with and without cardiovascular risk factors: Results from the AMBITION trial.,"BACKGROUND


The purpose of this study was to compare patients with pulmonary arterial hypertension enrolled in the AMBITION trial with (excluded from the primary analysis set [ex-primary analysis set]) and without (primary analysis set) multiple risk factors for left ventricular diastolic dysfunction.
METHODS


Treatment-naive patients with pulmonary arterial hypertension were randomized to once-daily ambrisentan and tadalafil combination therapy, ambrisentan monotherapy, or tadalafil monotherapy. The primary end point was time from randomization to first adjudicated clinical failure event.
RESULTS


Primary analysis set patients (n = 500), compared with ex-primary analysis set patients (n = 105), were younger (mean, 54.4 vs 62.1 years) with greater baseline 6-minute walk distance (median, 363.7 vs 330.5 meters) and fewer comorbidities (e.g., hypertension and diabetes). Treatment effects of initial combination therapy vs pooled monotherapy were directionally the same for both populations, albeit of a lower magnitude for ex-primary analysis set patients. Initial combination therapy reduced the risk of clinical failure compared with pooled monotherapy in primary analysis set patients (hazard ratio, 0.50; 95% confidence interval, 0.35-0.72), whereas the effect was less clear in ex-primary analysis set patients (hazard ratio, 0.70; 95% confidence interval, 0.35-1.37). Overall, primary analysis set patients had fewer clinical failure events (25% vs 33%), higher rates of satisfactory clinical response (34% vs 24%), and lower rates of permanent study drug withdrawal due to adverse events (16% vs 31%) than ex-primary analysis set patients.
CONCLUSIONS


Efficacy of initial combination therapy vs pooled monotherapy was directionally similar for primary analysis set and ex-primary analysis set patients. However, ex-primary analysis set patients (with multiple risk factors for left ventricular diastolic dysfunction) experienced higher rates of clinical failure events and the response to combination therapy vs monotherapy was attenuated. Tolerability was better in primary analysis set than ex-primary analysis set patients.",2019,"Treatment effects of initial combination therapy vs pooled monotherapy were directionally the same for both populations, albeit of a lower magnitude for ex-primary analysis set patients.","['Primary analysis set patients (n\u202f=\u202f500), compared with ex-primary analysis set patients (n\u202f=\u202f105), were younger (mean, 54.4 vs 62.1 years) with greater baseline 6-minute walk distance (median, 363.7 vs 330.5 meters) and fewer comorbidities (e.g., hypertension and diabetes', 'patients with pulmonary arterial hypertension enrolled in the AMBITION trial with (excluded from the primary analysis set [ex-primary analysis set]) and without (primary analysis set) multiple risk factors for left ventricular diastolic dysfunction', 'Treatment-naive patients with pulmonary arterial hypertension', 'Patients with pulmonary arterial hypertension with and without cardiovascular risk factors']","['daily ambrisentan and tadalafil combination therapy, ambrisentan monotherapy, or tadalafil monotherapy', 'initial combination therapy']","['risk of clinical failure', 'adverse events', 'Tolerability', 'time from randomization to first adjudicated clinical failure event', 'satisfactory clinical response', 'clinical failure events']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary hypertensive arterial disease (disorder)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",500.0,0.224609,"Treatment effects of initial combination therapy vs pooled monotherapy were directionally the same for both populations, albeit of a lower magnitude for ex-primary analysis set patients.","[{'ForeName': 'Vallerie V', 'Initials': 'VV', 'LastName': 'McLaughlin', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan. Electronic address: vmclaugh@med.umich.edu.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Vachiery', 'Affiliation': 'Cliniques Universitaires de Bruxelles-Hôpital Erasme, Brussels, Belgium.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Oudiz', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Rosenkranz', 'Affiliation': 'Department of Cardiology and Cologne Cardiovascular Research Center, Cologne University Heart Center, Cologne, Germany.'}, {'ForeName': 'Nazzareno', 'Initials': 'N', 'LastName': 'Galiè', 'Affiliation': 'University of Bologna, Bologna, Italy.'}, {'ForeName': 'Joan A', 'Initials': 'JA', 'LastName': 'Barberà', 'Affiliation': ""Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain; Biomedical Research Networking Center on Respiratory Diseases, Madrid, Spain.""}, {'ForeName': 'Adaani E', 'Initials': 'AE', 'LastName': 'Frost', 'Affiliation': 'Houston Methodist Institute for Academic Medicine, Houston, Texas.'}, {'ForeName': 'Hossein-Ardeschir', 'Initials': 'HA', 'LastName': 'Ghofrani', 'Affiliation': 'Universities of Giessen and Marburg Lung Center, Giessen, Germany.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Peacock', 'Affiliation': 'Scottish Pulmonary Vascular Unit, Regional Heart and Lung Centre, Glasgow, United Kingdom.'}, {'ForeName': 'Gérald', 'Initials': 'G', 'LastName': 'Simonneau', 'Affiliation': ""Université Paris Sud, Faculté de Médecine, Le Kremlin Bicêtre, France; AP-HP, Centre de Référence de l'Hypertension Pulmonaire Sévère, Département Hospitalo-Universitaire Thorax Innovation (TORINO), Service de Pneumologie, Hôpital de Bicêtre, Le Kremlin Bicêtre, France; UMR_S 999, Inserm, Laboratoire d'Excellence (LabEx) en Recherche sur le Médicament et l'Innovation Thérapeutique (LERMIT), Centre Chirurgical Marie Lannelongue, Le Plessis Robinson, France.""}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Rubin', 'Affiliation': 'University of California at San Diego, La Jolla, California.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Blair', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Langley', 'Affiliation': 'GlaxoSmithKline, Uxbridge, United Kingdom.'}, {'ForeName': 'Marius M', 'Initials': 'MM', 'LastName': 'Hoeper', 'Affiliation': 'Hannover Medical School, German Centre for Lung Research, Hannover, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2019.09.010']
494,31200945,Results from the randomized controlled IHOPE trial suggest no effects of oral protein supplementation and exercise training on physical function in hemodialysis patients.,"Few long-term studies have assessed whether changes in both diet and exercise can improve the health and quality of life (QOL) of hemodialysis (HD) patients. Here we examined whether 12 months of intradialytic protein supplementation and endurance exercise improves physical function, risk of cardiovascular disease (CVD), and QOL in HD patients in a randomized controlled trial (RCT). A total of 138 HD patients (average age 58 years) were assigned for 12 months to control, intradialytic protein, or protein plus exercise groups. The protein and protein plus exercise groups consumed an oral protein supplement (30 grams of whey) three days/week during dialysis. The protein plus exercise group cycled for 30-45 minutes during dialysis treatment. The primary outcome was change in physical function at 12 months, assessed by a shuttle walk test. Secondary outcomes included arterial stiffness, blood pressure, body composition, muscle strength, markers of nutritional status, and QOL. Assessments were conducted at baseline, 6 and 12 months. In total, 101 patients completed the intervention. There were no significant differences between groups in shuttle walk test performance from baseline to 12 months. There were trends for improvements in some secondary measures of physical function and strength in the protein and protein plus exercise groups at six or 12 months, but these did not reach statistical significance. Thus, our trial did not demonstrate significant improvements in markers of physical function, risk of CVD or QOL after one year of intradialytic oral OPS and aerobic exercise training. More comprehensive lifestyle management may be needed to uncover robust improvements in the health and QOL of HD patients.",2019,"There were trends for improvements in some secondary measures of physical function and strength in the protein and protein plus exercise groups at six or 12 months, but these did not reach statistical significance.","['138 HD patients (average age 58 years', 'hemodialysis patients', '101 patients completed the intervention']","['oral protein supplement', 'control, intradialytic protein, or protein plus exercise groups', 'oral protein supplementation and exercise training', 'intradialytic protein supplementation and endurance exercise']","['physical function', 'health and quality of\xa0life (QOL', 'shuttle walk test performance', 'markers of physical function, risk of CVD or QOL', 'physical function and strength', 'physical function, risk of cardiovascular disease (CVD), and QOL', 'arterial stiffness, blood pressure, body composition, muscle strength, markers of nutritional status, and QOL', 'change in physical function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034380'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",138.0,0.0452191,"There were trends for improvements in some secondary measures of physical function and strength in the protein and protein plus exercise groups at six or 12 months, but these did not reach statistical significance.","[{'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Jeong', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}, {'ForeName': 'Annabel', 'Initials': 'A', 'LastName': 'Biruete', 'Affiliation': 'Division of Nephrology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Tomayko', 'Affiliation': 'School of Biological and Population Health Sciences, Oregon State University, Corvallis, Oregon, USA.'}, {'ForeName': 'Pei Tzu', 'Initials': 'PT', 'LastName': 'Wu', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fitschen', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}, {'ForeName': 'Hae Ryong', 'Initials': 'HR', 'LastName': 'Chung', 'Affiliation': 'College of Health, Clayton State University, Atlanta, Georgia, USA.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Ali', 'Affiliation': 'College of Applied Health Science, University of Illinois, Chicago, Illinois, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'McAuley', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Fernhall', 'Affiliation': 'College of Applied Health Science, University of Illinois, Chicago, Illinois, USA.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Phillips', 'Affiliation': 'College of Applied Health Science, University of Illinois, Chicago, Illinois, USA.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Wilund', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA; Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA. Electronic address: kwilund@illinois.edu.'}]",Kidney international,['10.1016/j.kint.2019.03.018']
495,31227390,Impact of Adrenal Hormone Supplementation on Bone Geometry in Growing Teens With Anorexia Nervosa.,"PURPOSE


Adolescents with anorexia nervosa (AN) have decreased dehydroepiandrosterone (DHEA) and estrogen concentrations that may contribute to skeletal deficits. We sought to determine whether DHEA + estrogen replacement (ERT) prevented bone loss in young adolescents with AN.
METHODS


We recruited females with AN (n = 70, ages 11-18 years) into a 12-month, randomized, double-blind placebo-controlled trial. Participants were randomized to oral micronized DHEA 50 mg + 20 mcg ethinyl estradiol/.1 mg levonorgestrel daily (n = 35) or placebo (n = 35). Outcomes included serial measures of bone mineral density (BMD) by dual-energy X-ray absorptiometry (total body, hip, spine) and peripheral quantitative computed tomography (pQCT; tibia). Magnetic resonance imaging of T1-weighted images of the left knee determined physeal status (open/closed).
RESULTS


Sixty-two subjects completed the trial. Physeal closure status was the strongest predictor of aBMD changes. Among girls with open physes, those who received DHEA + ERT showed a decline in BMD Z-scores compared with those receiving placebo, whereas there was no effect in those with at least one closed physis. Treatment did not affect any pQCT measures, regardless of physeal closure status.
CONCLUSIONS


Combined DHEA + ERT did not significantly improve dual-energy X-ray absorptiometry or pQCT BMD measurements in young adolescent girls with AN, in contrast to an earlier trial showing benefit in older adolescents and young women. In girls with open physes, the mean change in the placebo arm was greater than that of the DHEA + ERT group. We conclude that DHEA + ERT is ineffective for preserving bone health in growing young adolescents with AN at the dose and route of administration described in this report.",2019,"Combined DHEA + ERT did not significantly improve dual-energy X-ray absorptiometry or pQCT BMD measurements in young adolescent girls with AN, in contrast to an earlier trial showing benefit in older adolescents and young women.","['Sixty-two subjects completed the trial', 'Growing Teens With Anorexia Nervosa', 'young adolescent girls', 'Adolescents with anorexia nervosa (AN', 'older adolescents and young women', 'young adolescents with AN.\nMETHODS\n\n\nWe recruited females with AN (n\xa0= 70, ages 11-18\xa0years']","['ethinyl estradiol/.1\xa0mg levonorgestrel', 'placebo', 'DHEA\xa0+\xa0ERT', 'oral micronized DHEA 50\xa0mg\xa0', 'Combined DHEA\xa0+ ERT', 'Adrenal Hormone Supplementation', 'DHEA\xa0+ estrogen replacement (ERT']","['BMD Z-scores', 'pQCT measures, regardless of physeal closure status', 'bone loss', 'dual-energy X-ray absorptiometry or pQCT BMD measurements', 'serial measures of bone mineral density (BMD) by dual-energy X-ray absorptiometry (total body, hip, spine) and peripheral quantitative computed tomography (pQCT; tibia']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1445654', 'cui_str': 'Adrenal hormone agent'}, {'cui': 'C0086258', 'cui_str': 'Estrogen Replacements'}]","[{'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}]",,0.498502,"Combined DHEA + ERT did not significantly improve dual-energy X-ray absorptiometry or pQCT BMD measurements in young adolescent girls with AN, in contrast to an earlier trial showing benefit in older adolescents and young women.","[{'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'DiVasta', 'Affiliation': ""Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, Massachusetts; Division of Gynecology, Boston Children's Hospital, Boston, Massachusetts. Electronic address: amy.divasta@childrens.harvard.edu.""}, {'ForeName': 'Henry A', 'Initials': 'HA', 'LastName': 'Feldman', 'Affiliation': ""Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston, Massachusetts; Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': ""O'Donnell"", 'Affiliation': 'Rutgers-Robert Wood Johnson Medical School, Piscataway, New Jersey.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'Division of Pediatric Nephrology, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Leonard', 'Affiliation': 'Division of Pediatric Nephrology, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Gordon', 'Affiliation': ""Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, Massachusetts; Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts.""}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2019.04.003']
496,31006955,"Lidocaine-Propitocain Cream, a Eutectic Mixture of Local Anesthetics, Effectively Relieves Pain Associated With Vascular Access Intervention Therapy in Patients Undergoing Hemodialysis: A Placebo-Controlled, Double-Blind, Crossover Study.","Vascular access intervention therapy (VAIVT) is necessary to maintain vascular access in patients undergoing hemodialysis. VAIVT-associated vasodilatation is painful. However, few reports have focused on effective pain relief at the time of VAIVT. The present study was performed to determine whether lidocaine-propitocain cream, a eutectic mixture of local anesthetics (EMLA), effectively reduces VAIVT-associated pain in patients undergoing hemodialysis. This placebo-controlled, double-blind, crossover study was conducted in a single center. Among 210 patients who underwent a total of 437 VAIVT procedures from August 2017 to June 2018, 30 patients were randomly allocated to either the EMLA-placebo arm or placebo-EMLA arm at the time of VAIVT. EMLA application significantly reduced the visual analog scale score compared with placebo (47.0 ± 21.1 vs. 68.6 ± 20.7 mm, respectively; P < 0.05). EMLA is a safe and effective treatment for relief of VAIVT-associated pain in patients undergoing hemodialysis.",2020,"EMLA application significantly reduced the visual analog scale score compared with placebo (47.0 ± 21.1 vs. 68.6 ± 20.7 mm, respectively; P < 0.05).","['210 patients who underwent a total of 437 VAIVT procedures from August 2017 to June 2018, 30 patients', 'Patients Undergoing Hemodialysis', 'patients undergoing hemodialysis']","['Lidocaine-Propitocain Cream, a Eutectic Mixture of Local Anesthetics', 'placebo', 'Placebo', 'Vascular access intervention therapy (VAIVT', 'EMLA', 'EMLA-placebo arm or placebo-EMLA', 'lidocaine-propitocain cream, a eutectic mixture of local anesthetics (EMLA']","['VAIVT-associated pain', 'effective pain relief', 'visual analog scale score']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0059079', 'cui_str': 'EMLA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",30.0,0.237464,"EMLA application significantly reduced the visual analog scale score compared with placebo (47.0 ± 21.1 vs. 68.6 ± 20.7 mm, respectively; P < 0.05).","[{'ForeName': 'Seishi', 'Initials': 'S', 'LastName': 'Aihara', 'Affiliation': 'Kidney Center, Matsuyama Red Cross Hospital, Matsuyama, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Shichijo', 'Affiliation': 'Kidney Center, Matsuyama Red Cross Hospital, Matsuyama, Japan.'}, {'ForeName': 'Kento', 'Initials': 'K', 'LastName': 'Fukumitsu', 'Affiliation': 'Kidney Center, Matsuyama Red Cross Hospital, Matsuyama, Japan.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': 'Kidney Center, Matsuyama Red Cross Hospital, Matsuyama, Japan.'}, {'ForeName': 'Yutaro', 'Initials': 'Y', 'LastName': 'Hirashima', 'Affiliation': 'Kidney Center, Matsuyama Red Cross Hospital, Matsuyama, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Oka', 'Affiliation': 'Kidney Center, Matsuyama Red Cross Hospital, Matsuyama, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Kamimura', 'Affiliation': 'Kidney Center, Matsuyama Red Cross Hospital, Matsuyama, Japan.'}, {'ForeName': 'Atsumi', 'Initials': 'A', 'LastName': 'Harada', 'Affiliation': 'Kidney Center, Matsuyama Red Cross Hospital, Matsuyama, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Nakano', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Tsuruya', 'Affiliation': 'Department of Nephrology, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Takanari', 'Initials': 'T', 'LastName': 'Kitazono', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}]","Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy",['10.1111/1744-9987.12813']
497,31179791,"Dupilumab improves patient-reported symptoms of atopic dermatitis, symptoms of anxiety and depression, and health-related quality of life in moderate-to-severe atopic dermatitis: analysis of pooled data from the randomized trials SOLO 1 and SOLO 2.","Background:  Atopic dermatitis (AD) profoundly affects quality of life (QoL). Dupilumab significantly improves clinical outcomes, is well tolerated, and approved to treat inadequately controlled moderate-to-severe AD in adults; however, its effect on patient-reported outcomes (PROs) is not fully characterized. Objective:  To evaluate the impact of dupilumab on patient-reported AD symptoms and QoL. Methods:  Pooled data were analyzed from two identically designed phase 3 studies, LIBERTY AD SOLO 1 (NCT02277743) and SOLO 2 (NCT02277769), assessing the following PROs: Peak Pruritus Numerical Rating Scale (NRS), Pruritus Categorical Scale, SCORing AD (SCORAD), Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), Hospital Anxiety and Depression Scale (HADS), five-dimension EuroQoL questionnaire (EQ-5D), and patient-assessed disease status and treatment effectiveness. Results:  Dupilumab rapidly improved (vs. placebo) Peak Pruritus NRS scores by day 2 ( p  < .05), anxiety and depression (HADS), and QoL (DLQI) by week 2, and maintained through week 16 ( p  < .0001). At week 16, more dupilumab-treated than placebo-treated patients reported improvement in SCORAD itch and sleep, and no pain/discomfort (EQ-5D) ( p  < .0001). Limitations:  Cultural differences of translated PROs. Conclusion:  Dupilumab had a significant, positive impact on AD symptoms, including itch, sleep, pain, anxiety and depression, and QoL in adults with moderate-to-severe AD.",2020,"Peak Pruritus NRS scores by day 2 ( p  < .05), anxiety and depression (HADS), and QoL (DLQI) by week 2, and maintained through week 16 ( p  < .0001).",[':  Atopic dermatitis (AD'],"['Dupilumab', 'placebo']","['clinical outcomes', 'PROs: Peak Pruritus Numerical Rating Scale (NRS), Pruritus Categorical Scale, SCORing AD (SCORAD), Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), Hospital Anxiety and Depression Scale (HADS), five-dimension EuroQoL questionnaire (EQ-5D), and patient-assessed disease status and treatment effectiveness', 'AD symptoms, including itch, sleep, pain, anxiety and depression, and QoL', 'Peak Pruritus NRS scores', 'quality of life (QoL', 'atopic dermatitis, symptoms of anxiety and depression, and health-related quality of life', 'anxiety and depression (HADS), and QoL (DLQI', 'SCORAD itch and sleep, and no pain/discomfort (EQ-5D']","[{'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C4304942', 'cui_str': 'Patient-Oriented Eczema Measure (assessment scale)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}]",,0.176387,"Peak Pruritus NRS scores by day 2 ( p  < .05), anxiety and depression (HADS), and QoL (DLQI) by week 2, and maintained through week 16 ( p  < .0001).","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Cork', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection and Immunity, University of Sheffield Medical School, Beech Hill, Sheffield, UK.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Eckert', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Armstrong', 'Affiliation': 'Department of Dermatology, Keck School of Medicine at USC, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Barbarot', 'Affiliation': 'Department of Dermatology, CHU Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Puig', 'Affiliation': 'Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Giampiero', 'Initials': 'G', 'LastName': 'Girolomoni', 'Affiliation': 'Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'de Bruin-Weller', 'Affiliation': 'University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Klinikum der Universität München, Klinik und Poliklinik für Dermatologie und Allergologie, Munich, Germany.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Kataoka', 'Affiliation': 'Department of Dermatology, Osaka Habikino Medical Center, Habikino City, Osaka, Japan.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Remitz', 'Affiliation': 'Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Beissert', 'Affiliation': 'Department of Dermatology, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Mastey', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Gadkari', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Jingdong', 'Initials': 'J', 'LastName': 'Chao', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1612836']
498,31787023,Non-linear is not superior to linear aerobic training periodization in coronary heart disease patients.,"BACKGROUND


We aimed to compare: (1) two different periodized aerobic training protocols (linear (LP) versus non-linear (NLP)) on the cardiopulmonary exercise response in patients with coronary heart disease; (2) the proportion of responders between both training protocols.
DESIGN


A randomized controlled trial.
METHODS


A total of 39 coronary heart disease patients completed either LP ( n  = 20, 65 ± 10 years) or NLP ( n  = 19, 66 ± 5 years). All patients completed a cardiopulmonary exercise testing with gas exchange measurements. Patients underwent a 12-week supervised exercise program including an isoenergetic aerobic periodized training and a similar resistance training program, 3 times/week. Weekly energy expenditure was constantly increased in the LP group for the aerobic training, while it was deeply increased and intercepted with a recovery week each fourth week in the NLP group. Peak oxygen uptake (peak V̇O 2 ), oxygen uptake efficiency slope, ventilatory efficiency slope (V̇E/V̇CO 2  slope), V̇O 2  at the first (VT 1 ) and second (VT 2 ) ventilatory thresholds, and oxygen pulse (O 2  pulse) were measured. Responders were determined according the median value of the Δpeak V̇O 2  (mL.min -1 .kg -1 ).
RESULTS


We found similar improvement for peak V̇O 2  (LP: +8.1%, NLP: +5.3%, interaction:  p  = 0.37; time:  p  < 0.001) and for oxygen uptake efficiency slope, VT 1 , VT 2  and O 2  pulse in both groups (interaction:  p  > 0.05; time:  p  < 0.05) with a greater effect size in the LP group. The proportion of non-, low and high responders was similar between groups ( p  = 0.29).
CONCLUSION


In contrast to the athletes, more variation (NLP) does not seem necessary for greater cardiopulmonary adaptations in coronary heart disease patients.",2020,"Weekly energy expenditure was constantly increased in the LP group for the aerobic training, while it was deeply increased and intercepted with a recovery week each fourth week in the NLP group.","['coronary heart disease patients', '39 coronary heart disease patients completed either LP ( n \u2009=\u200920, 65\u2009±\u200910 years) or', 'patients with coronary heart disease']","['cardiopulmonary exercise testing with gas exchange measurements', 'supervised exercise program including an isoenergetic aerobic periodized training and a similar resistance training program', 'NLP', 'periodized aerobic training protocols (linear (LP) versus non-linear (NLP']","['Peak oxygen uptake (peak V̇O 2 ), oxygen uptake efficiency slope, ventilatory efficiency slope (V̇E/V̇CO 2  slope), V̇O 2  at the first (VT 1 ) and second (VT 2 ) ventilatory thresholds, and oxygen pulse (O 2  pulse', 'oxygen uptake efficiency slope, VT 1 , VT 2  and O 2  pulse', 'Weekly energy expenditure']","[{'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0763527', 'cui_str': 'NLP (protease)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}]",39.0,0.0239188,"Weekly energy expenditure was constantly increased in the LP group for the aerobic training, while it was deeply increased and intercepted with a recovery week each fourth week in the NLP group.","[{'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Boidin', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (EPIC) Center, Montreal Heart Institute and Université de Montréal, Canada.'}, {'ForeName': 'Lukas-Daniel', 'Initials': 'LD', 'LastName': 'Trachsel', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (EPIC) Center, Montreal Heart Institute and Université de Montréal, Canada.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Nigam', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (EPIC) Center, Montreal Heart Institute and Université de Montréal, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Juneau', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (EPIC) Center, Montreal Heart Institute and Université de Montréal, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Tremblay', 'Affiliation': 'School of Kinesiology and Exercise Science, Faculty of Medicine, Université de Montréal, Canada.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Gayda', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (EPIC) Center, Montreal Heart Institute and Université de Montréal, Canada.'}]",European journal of preventive cardiology,['10.1177/2047487319891778']
499,30824296,A 16-yr Follow-up of the European Randomized study of Screening for Prostate Cancer.,"BACKGROUND


The European Randomized study of Screening for Prostate Cancer (ERSPC) has previously demonstrated that prostate-specific antigen (PSA) screening decreases prostate cancer (PCa) mortality.
OBJECTIVE


To determine whether PSA screening decreases PCa mortality for up to 16yr and to assess results following adjustment for nonparticipation and the number of screening rounds attended.
DESIGN, SETTING, AND PARTICIPANTS


This multicentre population-based randomised screening trial was conducted in eight European countries. Report includes 182160 men, followed up until 2014 (maximum of 16yr), with a predefined core age group of 162389 men (55-69yr), selected from population registry.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The outcome was PCa mortality, also assessed with adjustment for nonparticipation and the number of screening rounds attended.
RESULTS AND LIMITATIONS


The rate ratio of PCa mortality was 0.80 (95% confidence interval [CI] 0.72-0.89, p<0.001) at 16yr. The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr. The number of men needed to be invited for screening to prevent one PCa death was 570 at 16yr compared with 742 at 13yr. The number needed to diagnose was reduced to 18 from 26 at 13yr. Men with PCa detected during the first round had a higher prevalence of PSA >20ng/ml (9.9% compared with 4.1% in the second round, p<0.001) and higher PCa mortality (hazard ratio=1.86, p<0.001) than those detected subsequently.
CONCLUSIONS


Findings corroborate earlier results that PSA screening significantly reduces PCa mortality, showing larger absolute benefit with longer follow-up and a reduction in excess incidence. Repeated screening may be important to reduce PCa mortality on a population level.
PATIENT SUMMARY


In this report, we looked at the outcomes from prostate cancer in a large European population. We found that repeated screening reduces the risk of dying from prostate cancer.",2019,The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr.,"['eight European countries', '182160 men, followed up until 2014 (maximum of 16yr), with a predefined core age group of 162389 men (55-69yr), selected from population registry']",['PSA screening'],"['PCa mortality', 'rate ratio of PCa mortality', 'absolute PCa mortality', 'risk of dying from prostate cancer', 'PCa death', 'PCa mortality, also assessed with adjustment for nonparticipation and the number of screening rounds attended', 'number needed to diagnose']","[{'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]",,0.339695,The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr.,"[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Hugosson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden. Electronic address: jonas.hugosson@gu.se.'}, {'ForeName': 'Monique J', 'Initials': 'MJ', 'LastName': 'Roobol', 'Affiliation': 'Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Månsson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Teuvo L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'University of Tampere, Faculty of Medicine and Life Sciences, Tampere, Finland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Zappa', 'Affiliation': 'ISPRO, Oncological network, Prevention, and Research Institute, Florence, Italy.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Nelen', 'Affiliation': 'Provinciaal Instituut voor Hygiëne, Antwerp, Belgium.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Kwiatkowski', 'Affiliation': 'Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland; Department of Urology, Academic Hospital Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Lujan', 'Affiliation': 'Urology Department, Hospital Infanta Cristina, Parla, Madrid, Spain.'}, {'ForeName': 'Sigrid V', 'Initials': 'SV', 'LastName': 'Carlsson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden; Departments of Surgery (Urology Service) and Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Kirsi M', 'Initials': 'KM', 'LastName': 'Talala', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Lilja', 'Affiliation': 'Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK; Department of Translational Medicine, Lund University, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Denis', 'Affiliation': 'Europa Uomo, Oncology Centre Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Recker', 'Affiliation': 'Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Paez', 'Affiliation': 'Department of Urology, Hospital Universitario de Fuenlabrada, Madrid, Spain.'}, {'ForeName': 'Donella', 'Initials': 'D', 'LastName': 'Puliti', 'Affiliation': 'ISPRO, Oncological network, Prevention, and Research Institute, Florence, Italy.'}, {'ForeName': 'Arnauld', 'Initials': 'A', 'LastName': 'Villers', 'Affiliation': 'Department of Urology, CHU Lille, University Lille Nord de France, Lille, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Rebillard', 'Affiliation': 'Urology Department, Clinique Beau Soleil, Montpellier, France.'}, {'ForeName': 'Tuomas P', 'Initials': 'TP', 'LastName': 'Kilpeläinen', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ulf H', 'Initials': 'UH', 'LastName': 'Stenman', 'Affiliation': 'Department of Pathology, Fimlab Laboratories, Tampere, Finland.'}, {'ForeName': 'Rebecka Arnsrud', 'Initials': 'RA', 'LastName': 'Godtman', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Stinesen Kollberg', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Moss', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventative Medicine, Queen Mary University of London, Charterhouse Square, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Kujala', 'Affiliation': 'Department of Pathology, Fimlab Laboratories, Tampere, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Huber', 'Affiliation': 'Department of Laboratory Medicine, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Theodorus', 'Initials': 'T', 'LastName': 'van der Kwast', 'Affiliation': 'Laboratory Medicine Program, University Health Network, Toronto, Canada.'}, {'ForeName': 'Eveline A', 'Initials': 'EA', 'LastName': 'Heijnsdijk', 'Affiliation': 'Erasmus Medical Centre, Department of Public Health, Rotterdam, The Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bangma', 'Affiliation': 'Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'De Koning', 'Affiliation': 'Erasmus Medical Centre, Department of Public Health, Rotterdam, The Netherlands.'}, {'ForeName': 'Fritz H', 'Initials': 'FH', 'LastName': 'Schröder', 'Affiliation': 'Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'Prostate Cancer Research Center, Faculty of Social Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2019.02.009']
500,30712461,"A Pilot Investigation of Repetitive Transcranial Magnetic Stimulation for Post-Traumatic Brain Injury Depression: Safety, Tolerability, and Efficacy.","Depression following a traumatic brain injury (TBI) is common and difficult to treat using standard approaches. The current study investigated, for the first time, transcranial magnetic stimulation (TMS) for the treatment of post TBI depression. We specifically assessed the safety, tolerability, and efficacy of TMS in this patient population. We also explored cognitive outcomes. Twenty-one patients with a current episode of major depression subsequent to a TBI participated in a randomized double-blind placebo-controlled trial of repetitive TMS (rTMS). Sequential bilateral rTMS (to the left and right dorsolateral prefrontal cortex) was provided in 20 treatments over a period of 4 weeks. Patients were randomly allocated to receive either active or sham stimulation. There were no adverse effects and treatment was well tolerated. There was no significant effect of rTMS on post-TBI depression, with all patients showing a significant improvement in depressive symptoms irrespective of their treatment group ( p  = 0.002). There were significant improvements in cognition following active rTMS in the areas of working memory ( p  = 0.021) and executive function ( p  = 0.029). rTMS was shown to be safe and well tolerated in patients who had developed depression after a TBI. We did not find a therapeutic effect for post-TBI depression; however, this approach may have some utility in improving cognitive function. Future research should focus on alternative rTMS treatment approaches for post-TBI depression and the direct investigation of rTMS as a treatment for cognitive impairment in TBI.",2019,There were significant improvements in cognition following active rTMS in the areas of working memory ( p  = 0.021) and executive function ( p  = 0.029).,"['Post-Traumatic Brain Injury Depression', 'Twenty-one patients with a current episode of major depression subsequent to a TBI participated', 'patients who had developed depression after a TBI']","['active or sham stimulation', 'placebo', 'TMS', 'transcranial magnetic stimulation (TMS', 'Repetitive Transcranial Magnetic Stimulation', 'Sequential bilateral rTMS', 'repetitive TMS (rTMS', 'rTMS']","['safe and well tolerated', 'tolerated', 'depressive symptoms', 'safety, tolerability, and efficacy', 'executive function', 'post-TBI depression', 'cognition following active rTMS']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]",21.0,0.126677,There were significant improvements in cognition following active rTMS in the areas of working memory ( p  = 0.021) and executive function ( p  = 0.029).,"[{'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Hoy', 'Affiliation': '1 Monash Alfred Psychiatry Research Centre, Monash University and Alfred Health, Central Clinical School, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McQueen', 'Affiliation': '1 Monash Alfred Psychiatry Research Centre, Monash University and Alfred Health, Central Clinical School, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Elliot', 'Affiliation': '1 Monash Alfred Psychiatry Research Centre, Monash University and Alfred Health, Central Clinical School, Victoria, Australia.'}, {'ForeName': 'Sally E', 'Initials': 'SE', 'LastName': 'Herring', 'Affiliation': '2 Epworth Centre for Innovation in Mental Health, Epworth HealthCare, Camberwell, Victoria, Australia.'}, {'ForeName': 'Jerome J', 'Initials': 'JJ', 'LastName': 'Maller', 'Affiliation': '1 Monash Alfred Psychiatry Research Centre, Monash University and Alfred Health, Central Clinical School, Victoria, Australia.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': '1 Monash Alfred Psychiatry Research Centre, Monash University and Alfred Health, Central Clinical School, Victoria, Australia.'}]",Journal of neurotrauma,['10.1089/neu.2018.6097']
501,31229087,Mamey sapote fruit and carotenoid formulations derived thereof are dietary sources of vitamin A - A comparative randomized cross-over study.,"Mamey sapote is a fruit rich in specific keto-carotenoids, namely sapotexanthin and cryptocapsin. Their chemical structure suggests their provitamin A activity, although their absorption and conversion to vitamin A remained to be demonstrated in humans. Besides structure-related factors, the fruit matrix might also hamper absorption and conversion efficiency. Therefore, we monitored carotenoid and vitamin A levels in triacylglycerol-rich lipoprotein (TRL) fractions in plasma of human participants after consumption of fresh sapote and a carotenoid-rich ""matrix-free"" formulation derived thereof. A randomized 2-way cross-over study was conducted to compare the post-prandial bioavailability of 0.8 mg sapotexanthin and 1.2-1.5 mg cryptocapsin from the above-mentioned test meals. Seven blood samples were drawn over 9.5 h after test meal consumption. Carotenoids and retinoids were quantitated in TRL fractions using HPLC-DAD. Sapotexanthin was absorbed by all participants from all meals, being ca. 36% more bioavailable from the ""matrix-free"" formulation (AUC median  = 73.4 nmol∙h/L) than from the fresh fruit (AUC median  = 54.0 nmol∙h/L; p ≤ 0.001). Cryptocapsin was only absorbed by 4 of 13 participants. The appearance of retinyl esters was observed in all participants independent of the test meal. Although the fruit matrix hampered carotenoid in vivo-bioavailability from sapote, the fruit clearly represents a valuable source of vitamin A for humans.",2019,"36% more bioavailable from the ""matrix-free"" formulation (AUC median  = 73.4 nmol∙h/L) than from the fresh fruit (AUC median  = 54.0 nmol∙h/L; p ≤ 0.001).",[],['sapotexanthin and 1.2-1.5\u202fmg cryptocapsin'],"['appearance of retinyl esters', 'triacylglycerol-rich lipoprotein (TRL) fractions', 'post-prandial bioavailability']",[],"[{'cui': 'C3180638', 'cui_str': 'sapotexanthin'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0807756', 'cui_str': 'Retinyl ester'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}]",,0.0184025,"36% more bioavailable from the ""matrix-free"" formulation (AUC median  = 73.4 nmol∙h/L) than from the fresh fruit (AUC median  = 54.0 nmol∙h/L; p ≤ 0.001).","[{'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Chacón-Ordóñez', 'Affiliation': 'Institute of Food Science and Biotechnology, Chair Plant Foodstuff Technology and Analysis, University of Hohenheim, Garbenstrasse 25, D-70599 Stuttgart, Germany.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Esquivel', 'Affiliation': 'School of Food Technology, University of Costa Rica, 2060 San Pedro, Costa Rica.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Quesada', 'Affiliation': 'Department of Biochemistry, School of Medicine, University of Costa Rica, 2060 San Pedro, Costa Rica.'}, {'ForeName': 'Randall R', 'Initials': 'RR', 'LastName': 'Jiménez', 'Affiliation': 'Institute of Evolutionary Ecology and Conservation Genomics, University of Ulm, Albert-Einstein Allee 11, 89069 Ulm, Germany.'}, {'ForeName': 'Aracelly', 'Initials': 'A', 'LastName': 'Cordero', 'Affiliation': 'School of Food Technology, University of Costa Rica, 2060 San Pedro, Costa Rica.'}, {'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Carle', 'Affiliation': 'Institute of Food Science and Biotechnology, Chair Plant Foodstuff Technology and Analysis, University of Hohenheim, Garbenstrasse 25, D-70599 Stuttgart, Germany; Biological Science Department, King Abdulaziz University, P.O. Box 80257, Jeddah 21589, Saudi Arabia.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Schweiggert', 'Affiliation': 'Institute of Food Science and Biotechnology, Chair Plant Foodstuff Technology and Analysis, University of Hohenheim, Garbenstrasse 25, D-70599 Stuttgart, Germany; Analysis and Technology of Plant-based Foods, Department of Beverage Research, Geisenheim University, D-65366 Geisenheim, Germany. Electronic address: Ralf.Schweiggert@hs-gm.de.'}]","Food research international (Ottawa, Ont.)",['10.1016/j.foodres.2019.04.009']
502,31786715,"Shortening of the twitch stabilization period by tetanic stimulation in acceleromyography in infants, children and young adults (STSTS-Study): a prospective randomised, controlled trial.","Acceleromyography is characterised by an increase of the twitch response T1 (first twitch of the train-of-four [TOF]) during first 30 min of monitoring known as the staircase phenomenon. In adults the staircase phenomenon can be avoided by tetanic prestimulation. This study examined, if tetanic prestimulation eliminates the staircase phenomenon in children. After written informed consent, the neuromuscular function of 80 children, 10 in each age group (< 6 months, 6-12 months, 12-24 months, 2-3 years, 3-6 years, 6-12 years, 12-18 years, and ≥ 18 years) was measured on both arms simultaneously over 30 min under general anaesthesia. The ulnaris nerve was stimulated using the TOF technique every 15 s. The twitch response (T1, TOF ratio [TOFR]) was measured by acceleromyography. Before calibration, tetanic prestimmulation (50 Hz for 5 s) was administered to one randomly selected arm. The effect of tetanic prestimulation and age was analysed using general linear models based on the normalized T1 and TOFRs of both arms. Tetanic prestimulation significantly affected T1 values avoiding the staircase phenomenon (p < 0.0001). After 5.8 min [1.0-17.2 min] the normalized T1 values increased to 117% [102-147%] without prestimulation (p < 0.0001) independent of the age group (p = 0.539). The normalized TOFR was stable throughout the observation period of 30 min 100% [95-107%]. Infants (> 12 weeks), children, and young adults (< 18 years) develop similar characteristics of the staircase phenomenon than adults. Tetanic prestimulation prevents the staircase phenomenon in these age groups. The stability of the TOFR reading confirms its value to monitor neuromuscular function over time.Registration: The study was registered as NCT02552875 on Clinical Trials.gov on July 29, 2014.",2020,Tetanic prestimulation significantly affected T1 values avoiding the staircase phenomenon (p < 0.0001).,"['children', 'infants, children and young adults (STSTS-Study', 'Registration', 'Infants (>\u200912\xa0weeks), children, and young adults (<\u200918\xa0years) develop similar characteristics of the staircase phenomenon than adults']","['TOF technique', 'Acceleromyography', 'acceleromyography']","['twitch response T1', 'normalized TOFR', 'twitch response (T1, TOF ratio [TOFR', 'normalized T1 values']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C3805242', 'cui_str': 'Acceleromyography'}]","[{'cui': 'C0231530', 'cui_str': 'Muscle twitch (finding)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",80.0,0.0312584,Tetanic prestimulation significantly affected T1 values avoiding the staircase phenomenon (p < 0.0001).,"[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Unterbuchner', 'Affiliation': 'Department of Anesthesiology, University Medical Centre Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany. christoph.unterbuchner@ukr.de.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Werkmann', 'Affiliation': 'Department of Anesthesiology, University Medical Centre Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Ziegleder', 'Affiliation': 'Department of Anesthesiology, University Medical Centre Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kraus', 'Affiliation': 'Department of Anesthesiology, University Medical Centre Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Seyfried', 'Affiliation': 'Department of Anesthesiology, University Medical Centre Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Graf', 'Affiliation': 'Department of Anesthesiology, University Medical Centre Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Zeman', 'Affiliation': 'Centre for Clinical Studies, University Medical Centre, Regensburg, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Blobner', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Medical School, Technical University of Munich, Klinikum rechts der Isar, Munich, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Sinner', 'Affiliation': 'Department of Anesthesiology, University Medical Centre Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Metterlein', 'Affiliation': 'Department of Anesthesiology, University Medical Centre Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-019-00435-4']
503,31783132,Effects of Spicy Stimulation and Spicy-Food Consumption on Human Pain Sensitivity: A Healthy Volunteer Study.,"Spicy-food intake has been shown to affect various human physiological systems and diseases. This study tested the analgesia effect caused by stimulation of a spicy sensation (spicy stimulation) and explored the effect of spicy-food consumption on human basal pain sensitivity. A total of 60 healthy undergraduates were included in the primary study. Placebo and sweet stimulation were used as reference interventions. Pressure and cold-pain thresholds were measured before and after taste stimulation. The frequency of spicy-food intake was also evaluated. An additional 100 subjects were recruited to validate the results. Compared to placebo stimulation, both pressure and cold-pain thresholds increased during spicy stimulation (P < .05). The increased thresholds remained, even when the taste stimulation residue was nearly eliminated (P < .05). The pressure (10.0 [2.1] vs 12.7 [3.0] kg/cm2, P < .001) and cold-pain (4.4 [1.6] vs 6.2 [2.7] seconds, P = .003) thresholds in subjects who consume spicy food ≥3 days/week were significantly lower than in those who consume it <3 days/week. In the validation population, the frequency of spicy-food intake was negatively associated with subjects' pressure (β = -.218, P = .013) and cold-pain (β = -.205, P = .035) thresholds. Spicy stimulation has an analgesia effect on adults that persists even after the taste stimulation stops. Conversely, a long-term spicy diet can reduce the human basal pain threshold. TRIAL REGISTRATION: The study protocol was approved by the Medical Ethics Committee of the Second Affiliated Hospital of Army Medical University, People's Liberation Army (identification No., 2017-023-01), and it was registered on the Chinese Clinical Trial Registry at www.chictr.org.cn (No. ChiCTR1800015053). PERSPECTIVE: This study directly examined the effects of stimulation of a spicy sensation on adult pain sensitivity and was the first to explore the relationship between long-term spicy-food intake and human pain sensitivity. The results provide evidence for future clinical pain intervention and individualized pain treatment.",2020,"Compared to placebo stimulation, both pressure and cold-pain thresholds increased during spicy stimulation (P<0.05).","['60 healthy undergraduates were included in the primary\xa0study', 'healthy volunteer study', 'An additional 100 subjects', ""Medical Ethics Committee of the Second Affiliated Hospital of Army Medical University, People's Liberation Army (identification No., 2017-023-01), and it was registered on the Chinese Clinical Trial Registry at www.chictr.org.cn (No""]","['Spicy stimulation', 'spicy stimulation and spicy-food consumption', 'spicy sensation (spicy stimulation', 'Placebo and sweet stimulation', 'Spicy-food intake', 'spicy sensation', 'spicy-food consumption']","['frequency of spicy-food intake', 'pressure and cold-pain thresholds', 'Pressure and cold-pain thresholds', 'cold-pain', 'adult pain sensitivity', 'human basal pain sensitivity', 'human pain sensitivity']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0453864', 'cui_str': 'Spicy food (substance)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0559575', 'cui_str': 'Spicy food intake (observable entity)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0559575', 'cui_str': 'Spicy food intake (observable entity)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}]",60.0,0.093995,"Compared to placebo stimulation, both pressure and cold-pain thresholds increased during spicy stimulation (P<0.05).","[{'ForeName': 'Guangyou', 'Initials': 'G', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, PLA, Chongqing, China.'}, {'ForeName': 'Zhuoxi', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, PLA, Chongqing, China.'}, {'ForeName': 'Zhenxin', 'Initials': 'Z', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, PLA, Chongqing, China.'}, {'ForeName': 'Guiying', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, PLA, Chongqing, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, PLA, Chongqing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, PLA, Chongqing, China.'}, {'ForeName': 'Xiaohang', 'Initials': 'X', 'LastName': 'Bao', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, PLA, Chongqing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, PLA, Chongqing, China. Electronic address: lh78553@163.com.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.11.011']
504,31272939,Temsirolimus versus Pazopanib (TemPa) in Patients with Advanced Clear-cell Renal Cell Carcinoma and Poor-risk Features: A Randomized Phase II Trial.,"BACKGROUND


Temsirolimus has level 1 evidence for initial treatment of poor-risk patients with advanced renal cell carcinoma (mRCC), but its efficacy has not been directly compared with an antiangiogenic tyrosine kinase inhibitor (vascular endothelial growth factor receptor tyrosine kinase inhibitor [VEGFR TKi]) in this setting.
OBJECTIVE


To evaluate temsirolimus versus pazopanib as first-line therapy in patients with mRCC, predominant clear-cell features, and clinical characteristics of a poor prognosis.
DESIGN, SETTING, AND PARTICIPANTS


A randomized (1:1) phase II trial in 69 treatment-naïve mRCC patients and with three or more predictors of short survival for temsirolimus was conducted during 2012-2017 in a single academic cancer center. Crossover to the alternative treatment upon discontinuation of the first-line agent was permitted.
INTERVENTION


Mechanistic target of rapamycin inhibitor temsirolimus and VEGFR TKi pazopanib.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary endpoint was progression-free survival (PFS), and the secondary endpoints were overall survival (OS), objective response rate (ORR), safety, and patient-reported outcomes (PROs). Radiographic response was assessed by blinded radiologists. Efficacy outcomes were adjusted by prior nephrectomy status, prior interleukin-2 treatment, and the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score.
RESULTS AND LIMITATIONS


Thirty-five patients received temsirolimus and 34 received pazopanib upfront; 72% overall had poor risk by IMDC. Median PFS in the first line was 2.7mo with temsirolimus and 5.2mo with pazopanib (adjusted hazard ratio [HR] 1.36, 95% confidence interval [CI] 0.84-2.22; p=0.210). Median OS was 7.1mo with temsirolimus and 11.9mo with pazopanib (adjusted HR 1.16, 95% CI 0.70-1.93; p=0.558), and ORRs were 5.9% and 21.2%, respectively (adjusted odds ratio 5.2, 95% CI 0.9-29.3; p=0.062). PRO measures favored pazopanib. Five patients discontinued first-line therapy due to adverse events.
CONCLUSIONS


Temsirolimus and pazopanib had modest activity in patients with poor-risk clear-cell mRCC, and therefore their use should be discouraged in this setting.
PATIENT SUMMARY


We evaluated outcomes of advanced renal cell carcinoma patients presenting with aggressive features when treated with temsirolimus or pazopanib as first-line therapy. Survival was <1yr for most, suggesting that more efficacious alternative treatments should be favored for these patients.",2020,"Median PFS in the first line was 2.7mo with temsirolimus and 5.2mo with pazopanib (adjusted hazard ratio [HR] 1.36, 95% confidence interval [CI] 0.84-2.22; p=0.210).","['patients with mRCC', 'patients with poor-risk clear-cell mRCC', '69 treatment-naïve mRCC patients and with three or more predictors of short survival for temsirolimus was conducted during 2012-2017 in a single academic cancer center', 'Patients with Advanced Clear-cell Renal Cell Carcinoma and Poor-risk Features', 'advanced renal cell carcinoma patients presenting with aggressive features when treated with', 'poor-risk patients with advanced renal cell carcinoma (mRCC']","['Temsirolimus versus Pazopanib (TemPa', 'Temsirolimus and pazopanib', 'temsirolimus or pazopanib', 'rapamycin inhibitor temsirolimus and VEGFR TKi pazopanib', 'pazopanib', 'pazopanib upfront']","['progression-free survival (PFS', 'Survival', 'Radiographic response', 'overall survival (OS), objective response rate (ORR), safety, and patient-reported outcomes (PROs', 'Median OS', 'ORRs', 'International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius (cell)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1707080', 'cui_str': 'temsirolimus'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0279702', 'cui_str': 'Clear Cell Renal Carcinoma'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1707080', 'cui_str': 'temsirolimus'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",69.0,0.0983514,"Median PFS in the first line was 2.7mo with temsirolimus and 5.2mo with pazopanib (adjusted hazard ratio [HR] 1.36, 95% confidence interval [CI] 0.84-2.22; p=0.210).","[{'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: ntannir@mdanderson.org.'}, {'ForeName': 'Pavlos', 'Initials': 'P', 'LastName': 'Msaouel', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jeremy A', 'Initials': 'JA', 'LastName': 'Ross', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Devine', 'Affiliation': 'Department of Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Chandramohan', 'Affiliation': 'Department of Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Graciela M Nogueras', 'Initials': 'GMN', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Corn', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zita D', 'Initials': 'ZD', 'LastName': 'Lim', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Pruitt', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Karam', 'Affiliation': 'Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Wood', 'Affiliation': 'Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Amado J', 'Initials': 'AJ', 'LastName': 'Zurita', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",European urology oncology,['10.1016/j.euo.2019.06.004']
505,31800053,A Forced-Choice Procedure to Assess the Acute Relative Reinforcing Effects of Nicotine Dose per se in Humans.,"INTRODUCTION


A method to assess acute reinforcement due to nicotine may aid identification of doses needed to maintain dependence. After describing development of a forced-choice procedure, results are presented from two studies using it to determine the relative reinforcing effects of nicotine dose per se.
AIMS AND METHODS


Choice between a higher versus a very low or no nicotine option, via smoking (Study 1, n = 59) and via nasal spray (Study 2, n = 42), was assessed in nontreatment-seeking dependent smokers abstinent overnight. Using a within-subject design, different nicotine levels for each product were administered under blind conditions, initially to assess their discriminability (Study 1: 1.3-17 mg/g each vs. 0.4 mg/g nicotine Spectrum cigarettes; Study 2: 2.5 µg/kg vs. 0 µg/kg nicotine per spray). At the end of sessions for each study, participants engaged in forced-choice trials to assess preference, requiring a fixed number of puffs/sprays for one and/or the other.
RESULTS


Confirming the procedure's validity, the choice of the higher nicotine option was significantly greater than that for the very low or no nicotine option in both studies. In Study 1, choice relative to 0.4 mg/g was greater for cigarettes 5.3 mg/g or more but not 2.3 mg/g or less (p = .003 for the interaction of higher content vs. 0.4 mg/g comparison). In Study 2, choice was greater for the nicotine versus placebo spray (p < .005), as nicotine was preferred nearly twice as much as the placebo.
CONCLUSION


This forced-choice procedure may efficiently determine the relative reinforcing value of a nicotine dose per se.
IMPLICATIONS


The forced-choice procedure described here may identify nicotine doses that are acutely reinforcing in dependent smokers. A priori research of choice comparisons between small versus zero nicotine doses could inform clinical research in larger and more diverse samples to determine nicotine contents in cigarettes, and perhaps in other commercial products, that are not reinforcing and, thus, likely to reduce the risk of their addictiveness. This procedure may also be applicable to assessing changes in acute nicotine reinforcement due to different product formulations, novel drugs, or other manipulations, perhaps helping inform development of new interventions for cessation or harm reduction.",2020,"In Study 2, choice was greater for the nicotine vs. placebo spray (p<.005), as nicotine was preferred nearly twice as much as the placebo.
","['Humans', 'Choice between a higher vs. a very low or no nicotine option, via smoking (Study 1, n=59) and via nasal spray (Study 2, n=42), were assessed in non-treatment seeking dependent smokers abstinent overnight']","['placebo', 'nicotine vs. placebo', 'Nicotine', 'nicotine']",[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}]",[],,0.13249,"In Study 2, choice was greater for the nicotine vs. placebo spray (p<.005), as nicotine was preferred nearly twice as much as the placebo.
","[{'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Perkins', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Karelitz', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz224']
506,31232166,'No one ever asked us': a feasibility study assessing the co-creation of a physical activity programme with adolescent girls.,"BACKGROUND


Globally, the poor activity level of adolescent girls is a public health concern. Little research has involved adolescents in the design of interventions. This study assessed the feasibility of involving girls in the co-creation of an activity programme.
METHODS


Thirty-one students (15-17 years old) were recruited from a post-primary school. The Behaviour Change Wheel guided intervention design, providing insights into participants' capability, opportunity and motivation for change. Step counts and self-reported physical activity levels were recorded pre- and post-intervention. Feasibility benchmarks assessed recruitment, data collection, acceptability and adherence.
RESULTS


Activity and educational sessions were delivered for six weeks during physical education class. Average attendance was 87% (benchmark = 80%). Eligibility was 61% (benchmark = 60%). There was a 100% retention rate (benchmark = 90%). All participants ( n  = 31) completed baseline measures and 71% ( n  = 22) completed post-measures. 54% ( n  = 17) of students completed pedometer measurements, with 32% ( n  = 10) having complete data. Average daily steps were 13,121 pre-intervention and 14,128 post-intervention ( p  > 0.05). Data collection was feasible, receiving a mean score > 4/5 (benchmark > 3.5/5).
CONCLUSIONS


The Behaviour Change Wheel can be used to co-create an activity programme with adolescent girls. Predetermined benchmarks, except for pedometer recordings, were reached or exceeded, providing evidence for the need of a randomised controlled trial to test effectiveness.",2020,"Average daily steps were 13,121 pre-intervention and 14,128 post-intervention ( p  > 0.05).","['adolescent girls', 'Thirty-one students (15-17 years old) were recruited from a post-primary school']",['physical activity programme'],"['Feasibility benchmarks assessed recruitment, data collection, acceptability and adherence', 'Average attendance', 'Step counts and self-reported physical activity levels', 'retention rate', 'Average daily steps']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",,0.0464856,"Average daily steps were 13,121 pre-intervention and 14,128 post-intervention ( p  > 0.05).","[{'ForeName': 'Méabh', 'Initials': 'M', 'LastName': 'Corr', 'Affiliation': 'Department of Arts Education and Physical Education, Mary Immaculate College, Limerick, Ireland.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Murtagh', 'Affiliation': 'Department of Arts Education and Physical Education, Mary Immaculate College, Limerick, Ireland.'}]",Global health promotion,['10.1177/1757975919853784']
507,31775535,"Long-term safety, tolerability, and efficacy of magnesium valproate versus sodium valproate in acute seizures.","Objectives:  To evaluate the safety, tolerability and efficacy of magnesium valproate and sodium valproate as monotherapies in patients with epilepsy in China. Methods:  We recruited patients admitted with seizures over a two-year period. All patients underwent early neurological assessments, electroencephalogram testing, and neuroimaging. The treatments received at baseline and at one year of follow-up were compared. Results:  In total, 175 patients were included. The retention rates of the magnesium valproate and sodium valproate treatments were 73.1% and 64.2%, respectively. The main cause of discontinuation was the development of intolerable adverse events. The retention rate and total effective rate in the magnesium valproate group were significantly higher than those in the sodium valproate group (73.1% and 70.2% versus 64.2% and 47.2%, respectively). The safety endpoints included 120 patients (magnesium valproate:  n  = 67; sodium valproate:  n  = 53). The incidence of adverse events in the magnesium valproate group was significantly lower than that in the sodium valproate group (30% versus 51%). Conclusions:  Magnesium valproate treatment shows favorable safety and tolerability and is associated with markedly improved seizure control. Ideally, future large, prospective, randomized, and double-blind studies are needed to confirm these findings.",2020,The incidence of adverse events in the magnesium valproate group was significantly lower than that in the sodium valproate group (30% versus 51%).,"['patients with epilepsy in China', 'All patients underwent early neurological assessments, electroencephalogram testing, and neuroimaging', '175 patients were included', '120 patients (magnesium valproate: n\u2009=\u200967', 'n\u2009=\u200953', 'acute seizures', 'patients admitted with seizures over a two-year period']","['magnesium valproate', 'sodium valproate', 'Magnesium valproate', 'magnesium valproate and sodium valproate']","['retention rate and total effective rate', 'intolerable adverse events', 'incidence of adverse events', 'safety, tolerability and efficacy', 'retention rates', 'favorable safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0027853', 'cui_str': 'Neurological Examination'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0524735', 'cui_str': 'Magnesium Valproate'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0524735', 'cui_str': 'Magnesium Valproate'}, {'cui': 'C0037567', 'cui_str': 'Sodium Valproate'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",175.0,0.110474,The incidence of adverse events in the magnesium valproate group was significantly lower than that in the sodium valproate group (30% versus 51%).,"[{'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Chongqing Key Laboratory of Neurology, Department of Neurology, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Chongqing Key Laboratory of Neurology, Department of Neurology, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Chongqing Key Laboratory of Neurology, Department of Neurology, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Chongqing Key Laboratory of Neurology, Department of Neurology, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Chongqing Key Laboratory of Neurology, Department of Neurology, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}]",Current medical research and opinion,['10.1080/03007995.2019.1699520']
508,31804398,Five Year Follow-up of a Randomized Controlled Trial of Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh.,"OBJECTIVE


To determine whether absorbable or nonabsorbable mesh repair of large hiatus hernias is followed by less recurrences at late follow-up compared to sutured repair.
SUMMARY OF BACKGROUND DATA


Radiological recurrences have been reported in up to 30% of patients after repair of large hiatus hernias, and mesh repair has been proposed as a solution. Earlier trials have revealed mixed outcomes and early outcomes from a trial reported previously revealed no short-term advantages for mesh repair.
METHODS


Multicentre prospective double-blind randomized controlled trial of 3 methods of hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh. Primary outcome - hernia recurrence assessed by barium meal X-ray and endoscopy at 3-4 years. Secondary outcomes - clinical symptom scores at 2, 3, and 5 years.
RESULTS


126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh. Clinical outcomes were obtained at 5 years in 89.9%, and objective follow-up was obtained in 72.3%. A recurrent hernia (any size) was identified in 39.3% after suture repair, 56.7% - absorbable mesh, and 42.9% - nonabsorbable mesh (P = 0.371). Clinical outcomes were similar at 5 years, except chest pain, diarrhea, and bloat symptoms which were more common after repair with absorbable mesh.
CONCLUSIONS


No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh. The longer-term results from this trial do not support mesh repair for large hiatus hernias.",2019,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","['126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh']","['Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh', 'hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh', 'absorbable or nonabsorbable mesh repair']","['clinical symptom scores at 2, 3, and 5 years', 'recurrent hernia', 'chest pain, diarrhea, and bloat symptoms', 'hernia recurrence assessed by barium meal X-ray and endoscopy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh (physical object)'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0450093', 'cui_str': 'Very large (qualifier value)'}, {'cui': 'C3489393', 'cui_str': 'Hiatal Hernia'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh (physical object)'}, {'cui': 'C0014857', 'cui_str': 'Repair of parahiatal diaphragmatic hernia (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0412103', 'cui_str': 'Barium meal (procedure)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",126.0,0.479725,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Watson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Thompson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Devitt', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Aly', 'Affiliation': 'University of Melbourne Department of Surgery, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Irvine', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Woods', 'Affiliation': 'Cabrini Hospital, Malvern, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gan', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Game', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Glyn G', 'Initials': 'GG', 'LastName': 'Jamieson', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}]",Annals of surgery,['10.1097/SLA.0000000000003734']
509,31420191,Acute declines in estimated glomerular filtration rate on enalapril and mortality and cardiovascular outcomes in patients with heart failure with reduced ejection fraction.,"Angiotensin-converting enzyme inhibitors are beneficial in heart failure with reduced ejection fraction but are associated with acute declines in estimated glomerular filtration rate (eGFR). Prior studies evaluating thresholds of eGFR decline while using angiotensin-converting enzyme inhibitors in heart failure with reduced ejection have not taken into account this medication-driven decline. Here we used data from the Studies of Left Ventricular Dysfunction (SOLVD) trial of 6245 patients and performed Cox proportional hazards regression models to calculate hazard ratios of all-cause mortality and heart failure hospitalization-associated with percent eGFR decline at two- and six-weeks after randomization to enalapril versus placebo. In reference to placebo with equal degree of percent eGFR decline, any eGFR decline in the enalapril arm was associated with lower hazard of both outcomes. Under a conservative estimate using zero percent eGFR decline in the placebo arm as the reference, up to a 10% decline with enalapril was associated with mortality benefit (hazard ratio 0.87 [95% confidence interval 0.77, 0.99]) while up to a 35% decline was associated with decreased risk of heart failure hospitalization (0.78 [0.61, 0.98]). Under an intermediate estimate, up to a 15% decline with enalapril was associated with a mortality benefit (0.86 [0.77, 0.97]) and all levels of eGFR decline were associated with decreased risk of heart failure hospitalization. There was no percent eGFR decline, including up to 40%, in any models at either two- or six-weeks where enalapril was associated with higher mortality risk. Thus, in patients with reduced ejection fraction heart failure, enalapril is associated with decreased risk of mortality and heart failure hospitalizations. Hence, compelling reasons beyond moderate eGFR decline ought to be considered before its use is withdrawn.",2019,"There was no percent eGFR decline, including up to 40%, in any models at either two- or six-weeks where enalapril was associated with higher mortality risk.",['patients with heart failure with reduced ejection fraction'],"['enalapril versus placebo', 'angiotensin-converting enzyme inhibitors', 'Angiotensin-converting enzyme inhibitors', 'placebo', 'enalapril']","['risk of mortality and heart failure hospitalizations', 'mortality benefit', 'percent eGFR decline, any eGFR decline', 'risk of heart failure hospitalization', 'mortality risk', 'eGFR decline']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}]",6245.0,0.0819316,"There was no percent eGFR decline, including up to 40%, in any models at either two- or six-weeks where enalapril was associated with higher mortality risk.","[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'McCallum', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Hocine', 'Initials': 'H', 'LastName': 'Tighiouart', 'Affiliation': 'Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts, USA; Tufts Clinical and Translational Science Institute, Tufts University, Boston, Massachusetts, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Ku', 'Affiliation': 'Division of Nephrology and Pediatric Nephrology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Deeb', 'Initials': 'D', 'LastName': 'Salem', 'Affiliation': 'Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Sarnak', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Boston, Massachusetts, USA. Electronic address: msarnak@tuftsmedicalcenter.org.'}]",Kidney international,['10.1016/j.kint.2019.05.019']
510,31771436,Ketofol performance to reduce postoperative emergence agitation in children undergoing adenotonsillectomy.,"Background : Emergence agitation is a reformed state of mindfulness, which starts with a sudden form of anesthesia and progresses through the early repossession age. Thus, the purpose of this study is to evaluate 1:3 ketofol performance on children 3-15 years old undergoing adenotonsillectomy. Methods : A total of 60 children aged 3-15 years undergoing adenotonsillectomy were randomly allocated to receive low-dose ketamine 0.15 mg/kg followed by propofol 0.45 mg/kg i.v. ketofol (1:3) about 10 min before the end of surgery in comparison to 60 children aged 3-15 years who received only normal saline and dextrose. Anesthesia was induced and maintained with sevoflurane. Postoperative pain and EA were assessed with objective pain score (OPS) and the Pediatric Anesthesia Emergence Delirium (PAED) scale, respectively. EA was defined as a PAED 10 points. Recovery profile and postoperative complications were also recorded. Results : The incidence and severity of EA were found significantly lower in the ketofol group in comparison to the control group with a percentage of (13.33% vs 48.33%) (8% vs 15%) respectively (P < 0.05). Also, the time for interaction from anesthetic tainted to extubating in the ketofol set was significantly less than in the control group (P < 0.05). Interestingly, there are no opposing events such as nausea, laryngospasm, bronchospasm, hypotension, bradycardia, bleeding, or postoperative respiratory depression (respiratory rate: <16) were noticed in the ketofol supervision (P > 0.05). Moreover, the heart rate was meaningfully higher in the control group starting at the time of tracheal extubating in comparison to the children undergone ketofol (P < 0.05). Alert score and time from painkilling tainted till liberation from PACU showed substantial significant changes at ketofol set (P < 0.05). Conclusion : Ketofol (1:3) shows significant performance to reduce postoperative agitation in the children undergone adenotonsillectomy.",2020,The incidence and severity of EA were found significantly lower in the ketofol group in comparison to the control group with a percentage of (13.33% vs 48.33%) (8% vs 15%) respectively (P < 0.05).,"['children undergoing adenotonsillectomy', '60 children aged 3-15 years undergoing adenotonsillectomy', 'children undergone adenotonsillectomy', '60 children aged 3-15 years who received only', 'children 3-15 years old undergoing adenotonsillectomy']","['ketamine 0.15 mg/kg followed by propofol 0.45 mg/kg i.v', 'sevoflurane', ' ', 'normal saline and dextrose']","['postoperative agitation', 'nausea, laryngospasm, bronchospasm, hypotension, bradycardia, bleeding, or postoperative respiratory depression', 'Recovery profile and postoperative complications', 'incidence and severity of EA', 'heart rate', 'Postoperative pain and EA', 'objective pain score (OPS) and the Pediatric Anesthesia Emergence Delirium (PAED) scale']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C4068886', 'cui_str': '0.15 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C4068884', 'cui_str': '0.45'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0023066', 'cui_str': 'Laryngospasm'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0222045'}]",60.0,0.0935204,The incidence and severity of EA were found significantly lower in the ketofol group in comparison to the control group with a percentage of (13.33% vs 48.33%) (8% vs 15%) respectively (P < 0.05).,"[{'ForeName': 'Idress', 'Initials': 'I', 'LastName': 'Ali', 'Affiliation': 'Institute of Anesthesia and Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Murad', 'Initials': 'M', 'LastName': 'Alahdal', 'Affiliation': ""Shenzhen Key Laboratory of Tissue Engineering, Shenzhen Laboratory of Digital Orthopedic Engineering, Shenzhen Second People's Hospital (The First Hospital Affiliated to Shenzhen University, Health Science Center), Shenzhen, P. R. China.""}, {'ForeName': 'Haifa', 'Initials': 'H', 'LastName': 'Xia', 'Affiliation': 'Institute of Anesthesia and Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Arafa', 'Initials': 'A', 'LastName': 'S El Moughrabi', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Huang', 'Initials': 'H', 'LastName': 'Shiqian', 'Affiliation': 'Institute of Anesthesia and Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shanglong', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Institute of Anesthesia and Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",The Libyan journal of medicine,['10.1080/19932820.2019.1688450']
511,31784852,Hypotension Prediction Index based protocolized haemodynamic management reduces the incidence and duration of intraoperative hypotension in primary total hip arthroplasty: a single centre feasibility randomised blinded prospective interventional trial.,"The ""Hypotension Prediction Index (HPI)"" represents a newly introduced monitoring-tool that aims to predict episodes of intraoperative hypotension (IOH) before their occurrence. In order to evaluate the feasibility of protocolized care according to HPI monitoring, we hypothesized that HPI predicts the incidence of IOH and reduces the incidence and duration of IOH. This single centre feasibility randomised blinded prospective interventional trial included at total of 99 patients. One group was managed by goal-directed therapy algorithm based on HPI (HPI, n = 25), which was compared to a routine anaesthetic care cohort (CTRL, n = 24) and a third historic control group (hCTRL, n = 50). Primary endpoints included frequency (n)/h, absolute and relative duration (t (min)/% of total anaesthesia time) of IOH. Significant reduction of intraoperative hypotension was recorded in the HPI group compared to the control groups (HPI 48%, CTRL 87.5%, hCTRL 80%; HPI vs. CTRL, respectively hCTRL p < 0.001). Perioperative quantity of IOH was significantly reduced in the interventional group compared to both other study groups (HPI: 0 (0-1), CTRL: 5 (2-6), hCTRL: 2 (1-3); p < 0.001). Same observations were identified for absolute (HPI: 0 (0-140) s, CTRL: 640 (195-1315) s, hCTRL 660 (180-1440) s; p < 0.001) and relative duration of hypotensive episodes (minutes MAP ≤ 65 mmHg in  % of total anaesthesia time; HPI: 0 (0-1), CTRL: 6 (2-12), hCTRL 7 (2-17); p < 0.001). The HPI algorithm combined with a protocolized treatment was able to reduce the incidence and duration of hypotensive events in patients undergoing primary hip arthroplasty.Trial registration: NCT03663270.",2020,"Significant reduction of intraoperative hypotension was recorded in the HPI group compared to the control groups (HPI 48%, CTRL 87.5%, hCTRL 80%; HPI vs. CTRL, respectively hCTRL p < 0.001).","['patients undergoing primary hip arthroplasty', '99 patients', 'primary total hip arthroplasty']","['CTRL', 'routine anaesthetic care cohort (CTRL, n\u2009=\u200924) and a third historic control group (hCTRL, n\u2009=\u200950', 'Hypotension Prediction Index based protocolized haemodynamic management']","['incidence and duration of hypotensive events', 'incidence and duration of IOH', 'frequency (n)/h, absolute and relative duration (t (min)/% of total anaesthesia time) of IOH', 'Perioperative quantity of IOH', 'intraoperative hypotension', 'incidence and duration of intraoperative hypotension', 'relative duration of hypotensive episodes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic Drugs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0857353', 'cui_str': 'Hypotensive'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C0520541', 'cui_str': 'Hypotensive episode (disorder)'}]",99.0,0.115554,"Significant reduction of intraoperative hypotension was recorded in the HPI group compared to the control groups (HPI 48%, CTRL 87.5%, hCTRL 80%; HPI vs. CTRL, respectively hCTRL p < 0.001).","[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Schneck', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital of Giessen and Marburg, Rudolf-Buchheim-Street 7, 35392, Giessen, Germany. emmanuel.schneck@chiru.med.uni-giessen.de.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Schulte', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital of Giessen and Marburg, Rudolf-Buchheim-Street 7, 35392, Giessen, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Habig', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital of Giessen and Marburg, Rudolf-Buchheim-Street 7, 35392, Giessen, Germany.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Ruhrmann', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital of Giessen and Marburg, Rudolf-Buchheim-Street 7, 35392, Giessen, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Edinger', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital of Giessen and Marburg, Rudolf-Buchheim-Street 7, 35392, Giessen, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Markmann', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital of Giessen and Marburg, Rudolf-Buchheim-Street 7, 35392, Giessen, Germany.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Habicher', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital of Giessen and Marburg, Rudolf-Buchheim-Street 7, 35392, Giessen, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Rickert', 'Affiliation': 'Department of Orthopaedics and Orthopaedic Surgery, University Hospital Giessen and Marburg, Klinikstrasse 33, 35392, Giessen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Koch', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital of Giessen and Marburg, Rudolf-Buchheim-Street 7, 35392, Giessen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sander', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital of Giessen and Marburg, Rudolf-Buchheim-Street 7, 35392, Giessen, Germany.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-019-00433-6']
512,24958780,Longitudinal assessment of growth in hypoplastic left heart syndrome: results from the single ventricle reconstruction trial.,"BACKGROUND


We sought to characterize growth between birth and age 3 years in infants with hypoplastic left heart syndrome who underwent the Norwood procedure.
METHODS AND RESULTS


We performed a secondary analysis using the Single Ventricle Reconstruction Trial database after excluding patients <37 weeks gestation (N=498). We determined length-for-age z score (LAZ) and weight-for-age z score (WAZ) at birth and age 3 years and change in WAZ over 4 clinically relevant time periods. We identified correlates of change in WAZ and LAZ using multivariable linear regression with bootstrapping. Mean WAZ and LAZ were below average relative to the general population at birth (P<0.001, P=0.05, respectively) and age 3 years (P<0.001 each). The largest decrease in WAZ occurred between birth and Norwood discharge; the greatest gain occurred between stage II and 14 months. At age 3 years, WAZ and LAZ were <-2 in 6% and 18%, respectively. Factors associated with change in WAZ differed among time periods. Shunt type was associated with change in WAZ only in the Norwood discharge to stage II period; subjects with a Blalock-Taussig shunt had a greater decline in WAZ than those with a right ventricle-pulmonary artery shunt (P=0.002).
CONCLUSIONS


WAZ changed over time and the predictors of change in WAZ varied among time periods. By age 3 years, subjects remained small and three times as many children were short as were underweight (>2 SD below normal). Failure to find consistent risk factors supports the strategy of tailoring nutritional therapies to patient- and stage-specific targets.
CLINICAL TRIAL REGISTRATION URL


http://clinicaltrials.gov/. Unique identifier: NCT00115934.",2014,"Mean WAZ and LAZ were below average relative to the general population at birth (P<0.001, P=0.05, respectively) and age 3 years (P<0.001 each).","['patients <37 weeks gestation (N=498', 'infants with hypoplastic left heart syndrome who underwent the Norwood procedure', 'hypoplastic left heart syndrome']",['WAZ'],"['WAZ', 'length-for-age z score (LAZ) and weight-for-age z score (WAZ', 'Mean WAZ and LAZ', 'greatest gain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0152101', 'cui_str': 'Left Heart Hypoplasia Syndrome'}, {'cui': 'C2242650', 'cui_str': 'Norwood Procedures'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]",[],"[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",,0.123865,"Mean WAZ and LAZ were below average relative to the general population at birth (P<0.001, P=0.05, respectively) and age 3 years (P<0.001 each).","[{'ForeName': 'Phillip T', 'Initials': 'PT', 'LastName': 'Burch', 'Affiliation': 'Department of Surgery, University of Utah, Salt Lake City, UT (P.T.B., L.M.L.).'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Gerstenberger', 'Affiliation': 'New England Research Institutes, Watertown, MA (E.G., L.A.S.).'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Ravishankar', 'Affiliation': ""The Children's Hospital of Philadelphia, Philadelphia, PA (C.R.).""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hehir', 'Affiliation': ""The Children's Hospital of Wisconsin, Milwaukee, WI (D.A.H.).""}, {'ForeName': 'Ryan R', 'Initials': 'RR', 'LastName': 'Davies', 'Affiliation': 'Nemours/A.I. DuPont Hospital for Children, Wilmington, DE (R.R.D.).'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Colan', 'Affiliation': ""Children's Hospital Boston and Harvard Medical School, Boston, MA (S.D.C., J.W.N., C.D.M.).""}, {'ForeName': 'Lynn A', 'Initials': 'LA', 'LastName': 'Sleeper', 'Affiliation': 'New England Research Institutes, Watertown, MA (E.G., L.A.S.).'}, {'ForeName': 'Jane W', 'Initials': 'JW', 'LastName': 'Newburger', 'Affiliation': ""Children's Hospital Boston and Harvard Medical School, Boston, MA (S.D.C., J.W.N., C.D.M.).""}, {'ForeName': 'Martha L', 'Initials': 'ML', 'LastName': 'Clabby', 'Affiliation': 'The Hospital for Sick Children, Toronto, Ontario, Canada (M.L.C., S.K.).'}, {'ForeName': 'Ismee A', 'Initials': 'IA', 'LastName': 'Williams', 'Affiliation': 'Columbia University Medical Center, New York, NY (I.A.W.).'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': 'Duke University Medical Center, Durham, NC (J.S.L.).'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Uzark', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI (K.U.).'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Cooper', 'Affiliation': 'University of Cincinnati, Cincinnati, OH (D.S.C., J.B.A.).'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Lambert', 'Affiliation': 'Department of Surgery, University of Utah, Salt Lake City, UT (P.T.B., L.M.L.).'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Pemberton', 'Affiliation': 'National Institutes of Health, Bethesda, MD (V.L.P.).'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Pike', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA (N.A.P.).'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Anderson', 'Affiliation': 'University of Cincinnati, Cincinnati, OH (D.S.C., J.B.A.).'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Dunbar-Masterson', 'Affiliation': ""Children's Hospital Boston and Harvard Medical School, Boston, MA (S.D.C., J.W.N., C.D.M.).""}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Khaikin', 'Affiliation': 'The Hospital for Sick Children, Toronto, Ontario, Canada (M.L.C., S.K.).'}, {'ForeName': 'Sinai C', 'Initials': 'SC', 'LastName': 'Zyblewski', 'Affiliation': 'Medical University of South Carolina, Charleston, SC (S.C.Z.).'}, {'ForeName': 'L LuAnn', 'Initials': 'LL', 'LastName': 'Minich', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT (L.A.M.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.114.000079']
513,31366394,Bubble CPAP and oxygen for child pneumonia care in Malawi: a CPAP IMPACT time motion study.,"BACKGROUND


In some low-resource settings bubble continuous positive airway pressure (bCPAP) is increasingly used to treat children with pneumonia. However, the time required for healthcare workers (HCWs) to administer bCPAP is unknown and may have implementation implications. This study aims to compare HCW time spent administering bCPAP and low-flow nasal oxygen care at a district hospital in Malawi during CPAP IMPACT (Improving Mortality for Pneumonia in African Children Trial).
METHODS


Eligible participants were 1-59 months old with WHO-defined severe pneumonia and HIV-infection, HIV-exposure, severe malnutrition, or hypoxemia and were randomized to either bCPAP or oxygen. We used time motion techniques to observe hospital care in four hour blocks during treatment initiation or follow up (maintenance). HCW mean time per patient at the bedside over the observation period was calculated by study arm.
RESULTS


Overall, bCPAP required an average of 34.71 min per patient more than low-flow nasal oxygen to initiate (bCPAP, 118.18 min (standard deviation (SD) 42.73 min); oxygen, 83.47 min (SD, 20.18 min), p < 0.01). During initiation, HCWs spent, on average, 12.45 min longer per patient setting up bCPAP equipment (p < 0.01) and 11.13 min longer per patient setting up the bCPAP nasal interface (p < 0.01), compared to oxygen equipment and nasal cannula set-up. During maintenance care, HCWs spent longer on average per patient adjusting bCPAP, compared to oxygen equipment (bCPAP 4.57 min (SD, 4.78 min); oxygen, 1.52 min (SD, 2.50 min), p = 0.03).
CONCLUSION


Effective bCPAP implementation in low-resource settings will likely create additional HCW burden relative to usual pneumonia care with oxygen.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02484183 , June 29, 2015.",2019,"During maintenance care, HCWs spent longer on average per patient adjusting bCPAP, compared to oxygen equipment (bCPAP 4.57 min (SD, 4.78 min); oxygen, 1.52 min (SD, 2.50 min), p = 0.03).
","['Pneumonia in African Children Trial', 'child pneumonia care in Malawi', 'Eligible participants were 1-59\u2009months old with WHO-defined severe pneumonia and HIV-infection, HIV-exposure, severe malnutrition, or hypoxemia', 'children with pneumonia']","['bCPAP or oxygen', 'Bubble CPAP and oxygen', 'continuous positive airway pressure (bCPAP', 'bCPAP and low-flow nasal oxygen care']",['HCW mean time'],"[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0311276', 'cui_str': 'Severe malnutrition'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.213742,"During maintenance care, HCWs spent longer on average per patient adjusting bCPAP, compared to oxygen equipment (bCPAP 4.57 min (SD, 4.78 min); oxygen, 1.52 min (SD, 2.50 min), p = 0.03).
","[{'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Sessions', 'Affiliation': 'Mayo Clinic School of Medicine, 200 1st Street SW, Rochester, MN, USA. kristen.sessions@northwestern.edu.'}, {'ForeName': 'Tisungane', 'Initials': 'T', 'LastName': 'Mvalo', 'Affiliation': 'University of North Carolina Project Malawi, Tidziwe Centre, 100 Mzimba Road, Lilongwe, Malawi.'}, {'ForeName': 'Davie', 'Initials': 'D', 'LastName': 'Kondowe', 'Affiliation': 'University of North Carolina Project Malawi, Tidziwe Centre, 100 Mzimba Road, Lilongwe, Malawi.'}, {'ForeName': 'Donnie', 'Initials': 'D', 'LastName': 'Makonokaya', 'Affiliation': 'University of North Carolina Project Malawi, Tidziwe Centre, 100 Mzimba Road, Lilongwe, Malawi.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'University of North Carolina Project Malawi, Tidziwe Centre, 100 Mzimba Road, Lilongwe, Malawi.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Chalira', 'Affiliation': 'Community Health Science Unit, Private Bag, 65, Lilongwe, Malawi.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Lufesi', 'Affiliation': 'Community Health Science Unit, Private Bag, 65, Lilongwe, Malawi.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Eckerle', 'Affiliation': 'University of Cincinnati College of Medicine, 3333 Burnet Ave, Cincinnati, OH, 45229, USA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Smith', 'Affiliation': 'University of Utah, P.O. Box 581289, Salt Lake City, UT, 84158, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'McCollum', 'Affiliation': 'Johns Hopkins School of Medicine, Rubenstein Child Health Building, #3150, 200 North Wolfe Street, Baltimore, MD, 21287, USA.'}]",BMC health services research,['10.1186/s12913-019-4364-y']
514,31919749,Adefovir Dipivoxil plus Chinese Medicine in HBeAg-Positive Chronic Hepatitis B Patients: A Randomized Controlled 48-Week Trial.,"OBJECTIVE


To evaluate the effects of a 48-week course of adefovir dipivoxil (ADV) plus Chinese medicine (CM) therapy, namely Tiaogan Jianpi Hexue () and Tiaogan Jiedu Huashi () fomulae, in hepatitis B e antigen (HBeAg)-positive Chinese patients.
METHODS


A total of 605 HBeAg-positive Chinese CHB patients were screened and 590 eligible participants were randomly assigned to 2 groups in 1:1 ratio including experimental group (EG, received ADV plus CM) and control group (CG, received ADV plus CM-placebo) for 48 weeks. The major study outcomes were the rates of HBeAg and HBV-DNA loss on week 12, 24, 36, 48, respectively. Secondary endpoints including liver functions (enzymes and bilirubin readings) were evaluated every 4 weeks at the beginning of week 24, 36, and 48. Routine blood, urine, and stool analyses in addition to electrocardiogram and abdominal B scan were monitored as safety evaluations. Adverse events (AEs) were documented.
RESULTS


The combination therapy demonstrated superior HBeAg loss at 48 weeks, without additional AEs. The full analysis population was 560 and 280 in each group. In the EG, population achieved HBeAg loss on week 12, 24, 36, and 48 were 25 (8.90%), 34 (12.14%), 52 (18.57%), and 83 (29.64%), respectively; the equivalent numbers in the CG were 20 (7.14%), 41 (14.64%), 54 (19.29%), and 50 (17.86%), respectively. There was a statistically significant difference between these group values on week 48 (P<0.01). No additional AEs were found in EG. Subgroup analysis suggested different outcomes among treatment patterns.
CONCLUSION


Combination of CM and ADV therapy demonstrated superior HBeAg clearance compared with ADV monotherapy. The finding indicates that this combination therapy may provide an improved therapeutic effect and safety profile (ChiCTR-TRC-11001263).",2020,No additional AEs were found in EG.,"['605 HBeAg-positive Chinese CHB patients were screened and 590 eligible participants', 'hepatitis B', 'e antigen (HBeAg)-positive Chinese patients', 'HBeAg-Positive Chronic Hepatitis B Patients']","['adefovir dipivoxil (ADV) plus Chinese medicine (CM) therapy, namely Tiaogan Jianpi Hexue () and Tiaogan Jiedu Huashi () fomulae', 'Adefovir Dipivoxil plus Chinese Medicine', 'ADV plus CM) and control group (CG, received ADV plus CM-placebo']","['rates of HBeAg and HBV-DNA loss', 'HBeAg loss', 'therapeutic effect and safety profile', 'superior HBeAg clearance', 'Adverse events (AEs', 'superior HBeAg loss', 'liver functions (enzymes and bilirubin readings']","[{'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0312906', 'cui_str': ""Blood group antigen rh''""}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}]","[{'cui': 'C0540694', 'cui_str': 'adefovir dipivoxil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C1527144'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}]",,0.27711,No additional AEs were found in EG.,"[{'ForeName': 'Xiao-Ke', 'Initials': 'XK', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Institute of Liver Disease, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Ming-Xiang', 'Initials': 'MX', 'LastName': 'Zhang', 'Affiliation': ""Department of Hepatology, the Sixth People's Hospital of Shenyang, Shenyang, 110006, China.""}, {'ForeName': 'Feng-Zhen', 'Initials': 'FZ', 'LastName': 'Shao', 'Affiliation': 'Department of Hepatology, the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300000, China.'}, {'ForeName': 'Da-Qiao', 'Initials': 'DQ', 'LastName': 'Zhou', 'Affiliation': 'Department of Hepatology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, 518033, China.'}, {'ForeName': 'Jing-Dong', 'Initials': 'JD', 'LastName': 'Xue', 'Affiliation': ""Department of Hepatology, Shaanxi Hospital of Traditional Chinese Medicine, Xi'an, 710003, China.""}, {'ForeName': 'Tie-Jun', 'Initials': 'TJ', 'LastName': 'Liu', 'Affiliation': 'Affiliated Hospital of Changchun University of Chinese Medicine, Changchun, 130021, China.'}, {'ForeName': 'Xiao-Ling', 'Initials': 'XL', 'LastName': 'Chi', 'Affiliation': 'Department of Hepatology, Guangdong Hospital of Traditional Chinese Medicine, Guangzhou, 510006, China.'}, {'ForeName': 'Bing-Jiu', 'Initials': 'BJ', 'LastName': 'Lu', 'Affiliation': 'Department of Hepatology, Liaoning Hospital of Traditional Chinese Medicine, Shenyang, 110032, China.'}, {'ForeName': 'Xian-Bo', 'Initials': 'XB', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatology, Beijing Ditan Hospital, Beijing, 100015, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Hepatology, Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, 350025, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Hepatology, the 302 Military Hospital of PLA, Beijing, 100039, China.'}, {'ForeName': 'De-Wen', 'Initials': 'DW', 'LastName': 'Mao', 'Affiliation': 'Department of Hepatology, the First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning, 530023, China.'}, {'ForeName': 'Hua-Sheng', 'Initials': 'HS', 'LastName': 'Yang', 'Affiliation': 'Department of Integrated Traditional Chinese Medicine and Western Medicine, Beijing YouAn Hospital, Capital Medical University, Beijing, 100069, China.'}, {'ForeName': 'Hong-Zhi', 'Initials': 'HZ', 'LastName': 'Yang', 'Affiliation': 'Department of Traditional Chinese Medicine, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, China.'}, {'ForeName': 'Wen-Xia', 'Initials': 'WX', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450000, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Hepatology, Shandong Hospital of Traditional Chinese Medicine, Jinan, 250011, China.'}, {'ForeName': 'Guo-Liang', 'Initials': 'GL', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Anhui Hospital of Traditional Chinese Medicine, Hefei, 230031, China.'}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Zhao', 'Affiliation': 'Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, 100191, China.'}, {'ForeName': 'Jian-Dong', 'Initials': 'JD', 'LastName': 'Zou', 'Affiliation': 'Clinical Research Center, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing, 210029, China.'}, {'ForeName': 'Meng-Yang', 'Initials': 'MY', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Institute of Liver Disease, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Ke-Ke', 'Initials': 'KK', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Institute of Liver Disease, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Xian-Zhao', 'Initials': 'XZ', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Institute of Liver Disease, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Da-Nan', 'Initials': 'DN', 'LastName': 'Gan', 'Affiliation': 'Department of Gastroenterology, Institute of Liver Disease, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Institute of Liver Disease, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Institute of Liver Disease, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Zhi-Guo', 'Initials': 'ZG', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Institute of Liver Disease, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Institute of Liver Disease, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Yong-An', 'Initials': 'YA', 'LastName': 'Ye', 'Affiliation': 'Department of Gastroenterology, Institute of Liver Disease, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China. yeyongan@vip.163.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3250-0']
515,27302671,"Sugary beverage and food consumption, and leukocyte telomere length maintenance in pregnant women.","Leukocyte telomere length (LTL) has been inversely associated with sugar-sweetened beverage (SSB) consumption in cross-sectional studies, but no studies have examined whether dietary intake influences LTL over time. This study examined longitudinal associations between sugary foods and beverages and LTL. Participants were 65 overweight and obese pregnant women, aged 18-45 years, from a mindfulness intervention study conducted from early pregnancy (⩽16 weeks gestation) and followed through 9 months postpartum. During pregnancy and postpartum, dietary intake was measured with 24-h diet recalls, and LTL was assessed using quantitative PCR. Adjusting for sociodemographic and health characteristics, decreased SSB consumption from baseline to 9 months postpartum was associated with greater concurrent LTL lengthening (β=-0.102, 95% confidence interval (CI) -0.192, -0.013). No associations between sugary foods and LTL were found in either period. The finding that reduced SSB consumption is associated with increased LTL warrants investigation in large cohort studies.",2016,"Leukocyte telomere length (LTL) has been inversely associated with sugar-sweetened beverage (SSB) consumption in cross-sectional studies, but no studies have examined whether dietary intake influences LTL over time.","['Participants were 65 overweight and obese pregnant women, aged 18-45 years, from a mindfulness intervention study conducted from early pregnancy (⩽16 weeks gestation) and followed through 9 months postpartum', 'pregnant women']","['sugary foods and beverages and LTL', 'Leukocyte telomere length (LTL']",['SSB consumption'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C0453425', 'cui_str': 'Sugary food (substance)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0085187'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}]",65.0,0.0738084,"Leukocyte telomere length (LTL) has been inversely associated with sugar-sweetened beverage (SSB) consumption in cross-sectional studies, but no studies have examined whether dietary intake influences LTL over time.","[{'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'Leung', 'Affiliation': 'Center for Health and Community, School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Laraia', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Coleman-Phox', 'Affiliation': 'Center for Health and Community, School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'N R', 'Initials': 'NR', 'LastName': 'Bush', 'Affiliation': 'Center for Health and Community, School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Biochemistry and Biophysics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'E H', 'Initials': 'EH', 'LastName': 'Blackburn', 'Affiliation': 'Department of Biochemistry and Biophysics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Adler', 'Affiliation': 'Center for Health and Community, School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Epel', 'Affiliation': 'Center for Health and Community, School of Medicine, University of California, San Francisco, CA, USA.'}]",European journal of clinical nutrition,['10.1038/ejcn.2016.93']
516,31760109,Integrated Behavioral Treatment for Veterans With Co-Morbid Chronic Pain and Hazardous Opioid Use: A Randomized Controlled Pilot Trial.,"Opioid prescription in the treatment of chronic pain is frequent and carries a risk of increased morbidity and mortality in a clinically significant number of patients, particularly those who are using opioids in a hazardous manner. Few treatment options are available that target both pain-related interference and hazardous opioid use among patients with chronic pain. In military Veterans, this issue is of particular importance as numerous reports indicate continued high rates of opioid prescription for chronic pain, as well as significant opioid-related problems. The overall aim of the present study was to determine the feasibility of an integrated psychosocial treatment in Veterans with chronic pain, who also have evidence of hazardous opioid use. To examine this aim, a random design was used to assess the feasibility and initial efficacy of integrating 2 empirically supported interventions: Acceptance and Commitment Therapy for chronic pain and Mindfulness Based Relapse Prevention for opioid misuse. Half of participants were randomized to the integrated treatment group and all participants received usual care through a Veteran's Administration co-occurring disorders medical clinic to treat chronic pain and opioid misuse. In total, 37 participants were randomized and included in intent-to-treat analyses and 32 individuals were included in per protocol analyses with 6-month follow-up serving as the primary study endpoint. Feasibility indicators included recruitment, retention, and treatment completion rates. Recruitment fell short of targeted enrollment, although retention and completion were excellent. Primary outcome measures were opioid misuse, pain interference, and pain behavior. Simultaneous multiple regression analyses controlled for pain duration, baseline opioid dose, and baseline value for outcome measures. Results of both the intent-to-treat and per protocol indicated a significant effect in favor of the integrated intervention for opioid misuse, pain interference, and pain behavior. Results support the feasibility of providing an integrated treatment for both opioid risk and pain interference. PERSPECTIVE: Opioid misuse occurs in some opioid-prescribed individuals with chronic pain. Few treatment options exist that target both pain interference and opioid misuse. This study examined feasibility and initial efficacy of an integrated behavioral treatment for Veterans. Feasibility was supported, except recruitment. Efficacy was supported compared to usual care.",2020,"Results of both the ITT and PP indicated a significant effect in favor of the integrated intervention for opioid misuse, pain interference, and pain behavior.","['military Veterans', 'Veterans with co-morbid chronic pain and hazardous opioid use', 'Veterans', '37 participants were randomized and included in intent to treat (ITT) analyses and 32 individuals were included in per protocol (PP) analyses with 6-month follow-up serving as the primary study endpoint', 'individuals with chronic pain', 'patients with chronic pain', 'Veterans with chronic pain, who also have evidence of hazardous opioid use']","['Opioid prescription', 'integrated behavioral treatment', 'integrated psychosocial treatment', 'Integrated behavioral treatment', ""usual care (UC) through a Veteran's Administration co-occurring disorders medical clinic to treat chronic pain and opioid misuse""]","['opioid misuse, pain interference, and pain behavior', 'recruitment, retention, and treatment completion rates', 'Efficacy', 'feasibility and initial efficacy']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0041735', 'cui_str': 'United States. Dept. of Veterans Affairs'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0338037', 'cui_str': ""Private physicians' group office (environment)""}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",37.0,0.0734594,"Results of both the ITT and PP indicated a significant effect in favor of the integrated intervention for opioid misuse, pain interference, and pain behavior.","[{'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Vowles', 'Affiliation': ""School of Psychology, Queen's University Belfast, Belfast, Northern Ireland, United Kingdom.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Cusack', 'Affiliation': ""Raymond G. Murphy Veteran's Affairs Medical Center, New Mexico VA Healthcare System, Albuquerque, New Mexico.""}, {'ForeName': 'Wesley P', 'Initials': 'WP', 'LastName': 'Gilliam', 'Affiliation': 'Pain Rehabilitation Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Cardon', 'Affiliation': ""Raymond G. Murphy Veteran's Affairs Medical Center, New Mexico VA Healthcare System, Albuquerque, New Mexico.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bowen', 'Affiliation': 'Department of Psychology, Pacific University, Forest Grove, Oregon.'}, {'ForeName': 'Karlyn A', 'Initials': 'KA', 'LastName': 'Edwards', 'Affiliation': ""School of Psychology, Queen's University Belfast, Belfast, Northern Ireland, United Kingdom.""}, {'ForeName': 'Mindy L', 'Initials': 'ML', 'LastName': 'McEntee', 'Affiliation': 'College of Health Solutions, Arizona State University, Tempe, Arizona.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Bailey', 'Affiliation': 'Swedish Pain Services, Swedish Health System, Seattle, Washington.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.11.007']
517,31760586,A comparison of ventilation with a non-invasive ventilator versus standard O 2  with a nasal cannula for colonoscopy with moderate sedation using propofol.,"The aim of this study was to test the effects of CPAP on moderately sedated patients undergoing colonoscopy. Our hypothesis was that CPAP can reduce the incidence and duration of obstructive apnea and hemoglobin oxygen desaturation in patients undergoing procedural sedation for colonoscopy. Two groups of consenting adult patients scheduled to undergo routine colonoscopy procedures and sedated with propofol and fentanyl were monitored in this study: control and intervention. Patients in the intervention group were connected via a facemask to a ventilator that delivered supplemental oxygen (100%) through a standard air-cushion mask. The mask had a built-in leak to facilitate CO 2  clearance during CPAP. Patients in the control group received 2-10 L/min of oxygen via nasal cannula or non-rebreather mask. Subjects in the control group were collected in a prior study and used as historical controls. The primary outcome measures were the number of apneic events and the cumulative duration of apneic events. An apneic event was defined as a period longer than 10 s without respiration. The secondary outcome was the area under the curve (AUC) for the arterial oxygen saturation less than 90% versus time during sedative and analgesic administration (time (s) below threshold multiplied by percent below threshold). A desaturation event was defined as a period of time during which arterial oxygen saturation was less than 90%. 29 patients were enrolled in the intervention group and 156 patients were previously enrolled in the control group as part of an earlier study. The median number of apneic events in the control group was 7 compared to 0 in the intervention group. The intervention group experienced apnea less than 1% of the total procedure time compared to 17% in the control group (p < 0.001). There were no desaturation events observed in the 29 patients in the intervention group. In contrast, 27 out of 156 patients in the control group experienced a desaturation event. Average AUC of patients in the control group was 70%-s (time (s) * oxygen saturation below < 90%) (95% CI 32.34-108.60%) whereas the average AUC in intervention group patients was 0%-s (% time (s) * oxygen saturation < 90%) (95% CI 0-0%), p = 0.01. This preliminary study found that CPAP via a tight-fitting mask may be an effective tool to reduce the incidence and duration of obstructive apneic events as well as hemoglobin oxygen desaturation during lower endoscopy procedures that use propofol and fentanyl for sedation.Clinical Trial Registration ClinicalTrials.gov ID: NCT02623270. https://clinicaltrials.gov/ct2/show/NCT02623270 .",2020,oxygen saturation below < 90%) (95% CI 32.34-108.60%) whereas the average AUC in intervention group patients was 0%-s,"['moderately sedated patients undergoing colonoscopy', 'consenting adult patients scheduled to undergo routine colonoscopy procedures and sedated with', 'patients undergoing procedural sedation for colonoscopy', '29 patients were enrolled in the intervention group and 156 patients were previously enrolled in the control group as part of an earlier study']","['ventilation with a non-invasive ventilator versus standard O 2  with a nasal cannula', 'connected via a facemask to a ventilator that delivered supplemental oxygen (100%) through a standard air-cushion mask', 'propofol and fentanyl', '2-10 L/min of oxygen via nasal cannula or non-rebreather mask', 'CPAP', 'propofol']","['desaturation event', 'area under the curve (AUC) for the arterial oxygen saturation less', 'total procedure time', 'apnea less', 'desaturation events', 'hemoglobin oxygen desaturation', 'number of apneic events and the cumulative duration of apneic events', 'incidence and duration of obstructive apnea and hemoglobin oxygen desaturation', 'oxygen saturation', 'median number of apneic events']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0180249', 'cui_str': 'Cushion'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439393', 'cui_str': 'liter/minute'}, {'cui': 'C1960093', 'cui_str': 'Non-rebreather mask'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C2711000', 'cui_str': 'SaO2 - Arterial oxygen saturation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",156.0,0.0291266,oxygen saturation below < 90%) (95% CI 32.34-108.60%) whereas the average AUC in intervention group patients was 0%-s,"[{'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Fogarty', 'Affiliation': 'Department of Anesthesiology and Bioengineering, University of Utah, Salt Lake City, UT, USA. m.fogarty@utah.edu.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Orr', 'Affiliation': 'Department of Anesthesiology and Bioengineering, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Sakata', 'Affiliation': 'Department of Anesthesiology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Brewer', 'Affiliation': 'Department of Anesthesiology and Bioengineering, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Johnson', 'Affiliation': 'Department of Anesthesiology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Fang', 'Affiliation': 'Department of Gastroenterology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Kuck', 'Affiliation': 'Department of Anesthesiology and Bioengineering, University of Utah, Salt Lake City, UT, USA.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-019-00426-5']
518,31919768,"Learnability and reproducibility of ACR Thyroid Imaging, Reporting and Data System (TI-RADS) in postgraduate freshmen.","PURPOSE


The Thyroid Imaging, Reporting and Data System (TI-RADS) from the American College of Radiology (ACR) has been used since 2017 for the evaluation of thyroid nodules. The purpose of this study is to assess the learnability and reproducibility of TI-RADS in postgraduate freshmen.
METHODS


This was a retrospective study involving 400 nodules with a final diagnosis following ultrasound (US) examination. The nodules were randomized into eight groups (50/group). Three postgraduate freshmen and three experts evaluated the nodules according to ACR TI-RADS without knowledge of the final diagnosis. After evaluating each group, training was carried out based on the inconsistencies of the freshmen/experts. Training was stopped after 200 nodules because the κ value showed almost perfect concordance. Three months later, the 50 nodules of Group 4 (the last evaluated group) were re-evaluated to assess the reproducibility of ACR TI-RADS.
RESULTS


The diagnostic accuracy of the three postgraduate freshmen increased from 60%, 48%, and 46% in Group 1 to 80%, 78%, and 72% in Group 4 (P= 0.029, 0.002, and 0.008), respectively. After training, the diagnostic accuracy of the postgraduate freshmen was close to that of the experts (84%). For the US features, the postgraduate freshmen were consistent with the experts (all κ > 0.6). When re-evaluating Group 4 three months later, the five features had substantial to almost perfect agreement for the same researcher (all κ > 0.7).
CONCLUSION


Based on experts' consensus, ACR TI-RADS can be learned well, and its reproducibility is excellent.",2020,"The diagnostic accuracy of the three postgraduate freshmen increased from 60%, 48%, and 46% in Group 1 to 80%, 78%, and 72% in Group 4 (P= 0.029, 0.002, and 0.008), respectively.",['400 nodules with a final diagnosis following ultrasound (US) examination'],['TI-RADS'],"['diagnostic accuracy of the postgraduate freshmen', 'reproducibility of ACR TI-RADS', 'diagnostic accuracy', 'Learnability and reproducibility of ACR Thyroid Imaging, Reporting and Data System']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C0332144', 'cui_str': 'Final diagnosis (discharge) (contextual qualifier) (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}]","[{'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C0373397', 'cui_str': 'Thyroid imaging (procedure)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",400.0,0.0188304,"The diagnostic accuracy of the three postgraduate freshmen increased from 60%, 48%, and 46% in Group 1 to 80%, 78%, and 72% in Group 4 (P= 0.029, 0.002, and 0.008), respectively.","[{'ForeName': 'Dengke', 'Initials': 'D', 'LastName': 'Teng', 'Affiliation': 'Department of Ultrasound, China-Japan Union Hospital of Jilin University, Changchun, 130000, Jilin, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Fu', 'Affiliation': 'Department of Ultrasound, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, Jiangxi, China.'}, {'ForeName': 'Wenjia', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Breast Surgery, China-Japan Union Hospital of Jilin University, Changchun, 130000, Jilin, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Guo', 'Affiliation': 'Department of Ultrasound, China-Japan Union Hospital of Jilin University, Changchun, 130000, Jilin, China. guofeng_tdk@163.com.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Ultrasound, China-Japan Union Hospital of Jilin University, Changchun, 130000, Jilin, China. wanghui_tdk@163.com.'}]",Endocrine,['10.1007/s12020-019-02161-y']
519,31154664,Maternal Serum Lipid Trajectories and Association with Pregnancy Loss and Length of Gestation.,"OBJECTIVE


We characterized lipid trajectories and investigated lipids and rate of pregnancy lipid change with the risk of pregnancy loss or preterm delivery <37 weeks.
STUDY DESIGN


In a secondary analysis of 337 women with one to two prior losses assigned to placebo in a randomized controlled trial at four centers (2007-2012), cholesterol, low- and high-density lipoprotein cholesterol (HDL-C), and triglycerides were measured up to 6 months prepregnancy (time 0) and pregnancy up to 7 visits. Trajectories were created using linear mixed models. Multivariable logistic regression with adjustment for maternal characteristics and cholesterol was performed.
RESULTS


Lipids decreased from prepregnancy to 4 to 5 weeks, followed by an increase, and were biphasic or triphasic depending on the lipid component. Between 4 and 8 weeks, for every 1-unit increase in HDL-C, there was a 22% decreased odds of loss <14 weeks (odds ratio: 0.78; 95% confidence interval: 0.60, 0.99) and 24% decreased odds of loss or preterm delivery 14 to <37 weeks (odds ratio: 0.76; 95% confidence interval: 0.60, 0.96).
CONCLUSION


There were no associations with other lipid components or other time points. An impaired rise of HDL-C early in pregnancy may signal maladaptation to pregnancy that is associated with pregnancy loss or preterm delivery.",2020,There were no associations with other lipid components or other time points.,['337 women with one to two prior losses assigned to'],['placebo'],"['HDL-C', 'Maternal Serum Lipid Trajectories and Association with Pregnancy Loss and Length of Gestation', 'cholesterol, low- and high-density lipoprotein cholesterol (HDL-C), and triglycerides']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",337.0,0.217667,There were no associations with other lipid components or other time points.,"[{'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Grantz', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Elmi', 'Affiliation': 'Biostatistics and Bioinformatics Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Pugh', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Catov', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Science and Department of Epidemiology, Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Sjaarda', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Albert', 'Affiliation': 'Biostatistics and Bioinformatics Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}]",American journal of perinatology,['10.1055/s-0039-1689000']
520,31754238,Exercise effects on arterial stiffness and heart health in children with excess weight: The SMART RCT.,"INTRODUCTION


Childhood obesity and inactivity are associated with cardiovascular risk. Evidence is limited for exercise effects on arterial health in children.
METHODS


One hundred and seventy-five inactive children with overweight or obesity (8-11 years, ≥85th percentile BMI, 61% female, 87% Black, 73% with obesity) were randomized to an 8-month daily after-school aerobic exercise program (40 min/day, n = 90) or a sedentary control condition (n = 85). Carotid-femoral pulse wave velocity (PWV, primary outcome, arterial stiffness), fitness, adiposity, blood pressure (BP), glucose, insulin resistance, lipids, and C-reactive protein were measured at baseline and posttest (8 months). Adiposity, fitness, and BP were measured again at follow-up, 8-12 months later. Intent-to-treat analyses were conducted using mixed models.
RESULTS


The study had 89% retention, with attendance of 59% in exercise and 64% in the control condition, and vigorous exercise participation (average heart rate 161 ± 7 beats/min). Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2  peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001). There was no group × time effect on other outcomes at 8 months, or on any outcomes at follow-up. The change in PWV at 8 months correlated with changes in insulin and insulin resistance (both r = 0.32), diastolic BP (r = 0.24), BMI (r = 0.22), and adiposity (r = 0.18).
CONCLUSIONS


Eight months of aerobic exercise training improved fitness, adiposity, and HDL-cholesterol levels, but did not reduce arterial stiffness in children with excess weight. PWV improved as a function of insulin resistance, BP, BMI, and adiposity. Weight loss may be required to improve arterial stiffness. Exercise benefits waned after discontinuing the program.",2020,"Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2  peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001).","['children', 'children with excess weight', 'The study had 89% retention, with attendance of 59% in exercise and 64% in the control condition, and vigorous exercise participation (average heart rate 161\u2009±\u20097 beats/min', 'One hundred and seventy-five inactive children with overweight or obesity (8-11 years, ≥85th percentile BMI, 61% female, 87% Black, 73% with obesity']","['school aerobic exercise program (40\u2009min/day, n\u2009=\u200990) or a sedentary control condition', 'aerobic exercise training']","['insulin and insulin resistance', 'Adiposity, fitness, and BP', 'arterial stiffness', 'function of insulin resistance, BP, BMI, and adiposity', 'fitness, adiposity, and HDL-cholesterol levels', 'Weight loss', 'HDL-cholesterol', 'adiposity', 'arterial stiffness and heart health', 'diastolic BP', 'BMI', 'Carotid-femoral pulse wave velocity (PWV, primary outcome, arterial stiffness), fitness, adiposity, blood pressure (BP), glucose, insulin resistance, lipids, and C-reactive protein', 'change in PWV']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439385', 'cui_str': 'beats per minute'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0556973', 'cui_str': 'mins/day'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",175.0,0.0968893,"Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2  peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001).","[{'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Davis', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA. katie.davis@augusta.edu.'}, {'ForeName': 'Sheldon E', 'Initials': 'SE', 'LastName': 'Litwin', 'Affiliation': 'Cardiology, Medicine, MCG, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Norman K', 'Initials': 'NK', 'LastName': 'Pollock', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Waller', 'Affiliation': 'Population Health Sciences, MCG, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Gaston', 'Initials': 'G', 'LastName': 'Kapuku', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jigar', 'Initials': 'J', 'LastName': 'Bhagatwala', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Harris', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Looney', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Celestine F', 'Initials': 'CF', 'LastName': 'Williams', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Armento', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Schmidt', 'Affiliation': 'Kinesiology, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Bassali', 'Affiliation': 'Pediatrics, MCG, Augusta University, Augusta, GA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0482-1']
521,31152372,A biased coin up-and-down sequential allocation trial to determine the optimum programmed intermittent epidural bolus time interval between 5 mL boluses of bupivacaine 0.125% with fentanyl 2 µg·mL -1 .,"PURPOSE


The optimal epidural mixtures and settings for programmed intermittent epidural bolus (PIEB) labour analgesia have yet to be determined. A previous study by our group demonstrated that 10 mL boluses of bupivacaine 0.0625% with fentanyl 2 µg·mL -1  administered every 40 min provided effective analgesia during the first stage of labour for 90% of women, without breakthrough pain. We wanted to determine the effective PIEB time interval of 5 mL boluses of bupivacaine 0.125% with fentanyl 2 µg·mL -1  under the same study circumstances, aiming at a future comparative study.
METHODS


This double-blind dose-finding study used the biased coin up-and-down sequential allocation method to determine the effective PIEB interval 90% (EI90) needed to provide effective analgesia without breakthrough pain during the first stage of labour. We used fixed 5 mL boluses of bupivacaine 0.125% with fentanyl 2 µg.mL -1  and studied time intervals of 60, 50, 40, and 30 min. The first patient was assigned an interval of 60 min and the remaining intervals were assigned as per the biased coin up-and-down method.
RESULTS


The estimated EI90 was 36.5 min (95% confidence interval [CI], 34.0 to 39.0) by the truncated Dixon and Mood method and 34.2 min (95% CI, 30.8 to 41.5) by the isotonic regression method. We found that 20/40 women had an upper sensory block to ice above T6, 34/40 women had no motor block, and no woman required treatment for hypotension.
CONCLUSION


The EI90 between 5 mL boluses of bupivacaine 0.125% with fentanyl 2 µg·mL -1  during the first stage of labour is approximately 35 min.
TRIAL REGISTRATION


www.clinicaltrials.gov (NCT #02758405); registered 2 May, 2016.",2019,"The EI90 between 5 mL boluses of bupivacaine 0.125% with fentanyl 2 µg·mL -1  during the first stage of labour is approximately 35 min.
","['20/40 women had an upper sensory block to ice above T6, 34/40 women had no motor block, and no woman required treatment for hypotension']",['bupivacaine'],['effective PIEB time interval'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0349714', 'cui_str': 'Icing (substance)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.171831,"The EI90 between 5 mL boluses of bupivacaine 0.125% with fentanyl 2 µg·mL -1  during the first stage of labour is approximately 35 min.
","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Bittencourt', 'Affiliation': 'Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada. ricardob22@hotmail.com.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Arzola', 'Affiliation': 'Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Zakus', 'Affiliation': 'Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Downey', 'Affiliation': 'Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Xiang Y', 'Initials': 'XY', 'LastName': 'Ye', 'Affiliation': 'Department of Pediatrics, Micare Research Centre, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jose Carlos Almeida', 'Initials': 'JCA', 'LastName': 'Carvalho', 'Affiliation': 'Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01407-7']
522,31119846,Effects of Sustained-Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis: CASSIOPEIR Study Results.,"TRK-100STP, a sustained-release preparation of the orally active prostacyclin analogue beraprost sodium, targets renal hypoxia. This study aimed to show the superiority of TRK-100STP over placebos in patients with chronic kidney disease (with either primary glomerular disease or nephrosclerosis) to determine the recommended dose. CASSIOPEIR (Chronic Renal Failure Asian Study with Oral PGI 2  Derivative for Evaluating Improvement of Renal Function) was a randomized, double-blind, placebo-controlled study conducted at 160 sites in seven Asia-Pacific countries and regions. Eligible patients (n = 892) were randomized to TRK-100STP 120, 240 μg, or placebo for a treatment period of up to 4 years. The primary efficacy endpoint was time to first occurrence of a renal composite: doubling of serum creatinine or occurrence of end-stage renal disease. No significant differences were observed in composite endpoints between TRK-100STP and placebo (P = 0.5674). Hazard ratios (95% CI) in the TRK-100STP 120 and 240 μg vs. placebo groups were 0.98 (0.78, 1.22) and 0.91 (0.72, 1.14), respectively. The overall incidence of adverse events and adverse drug reactions was comparable between treatment arms.",2020,No significant differences were observed in composite endpoints between TRK-100STP and placebo (P=0.5674).,"['patients with chronic kidney disease (with either primary glomerular disease or nephrosclerosis', 'Eligible patients (n=892', '160 sites in seven Asian-Pacific countries', 'patients with primary glomerular disease or nephrosclerosis']","['placebo', 'TRK-100STP and placebo', 'TRK-100STP over placebo', 'TRK-100STP', 'sustained-release beraprost']","['time to first occurrence of a renal composite: doubling of serum creatinine or occurrence of end-stage renal disease', 'overall incidence of adverse events and adverse drug reactions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0268731', 'cui_str': 'Glomerular disease (disorder)'}, {'cui': 'C0027719', 'cui_str': 'Nephrosclerosis'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0053336', 'cui_str': 'beraprost'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}]",892.0,0.179045,No significant differences were observed in composite endpoints between TRK-100STP and placebo (P=0.5674).,"[{'ForeName': 'Hidetomo', 'Initials': 'H', 'LastName': 'Nakamoto', 'Affiliation': 'Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Xue-Qing', 'Initials': 'XQ', 'LastName': 'Yu', 'Affiliation': 'The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou City, China.'}, {'ForeName': 'Suhnggwon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul K Clinic, Seoul, South Korea.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Origasa', 'Affiliation': 'The University of Toyama, Toyama, Japan.'}, {'ForeName': 'Hongguang', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'The General Hospital of Shenyang Military Command, Shenyang City, China.'}, {'ForeName': 'Jianghua', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Kwon Wook', 'Initials': 'KW', 'LastName': 'Joo', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Suchai', 'Initials': 'S', 'LastName': 'Sritippayawan', 'Affiliation': 'Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Qinkai', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Hung-Chun', 'Initials': 'HC', 'LastName': 'Chen', 'Affiliation': 'Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Tsubakihara', 'Affiliation': 'Graduate School of Health Care Sciences, Jikei Institute, Osaka, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tamai', 'Affiliation': 'Anjo Kosei Hospital, Aichi, Japan.'}, {'ForeName': 'Sang Heon', 'Initials': 'SH', 'LastName': 'Song', 'Affiliation': 'Pusan National University Hospital, Busan, South Korea.'}, {'ForeName': 'Indralingam', 'Initials': 'I', 'LastName': 'Vaithilingam', 'Affiliation': 'Hospital Taiping, Perak, Malaysia.'}, {'ForeName': 'Kang Wook', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Chungnam National University Hospital, Daejeon, South Korea.'}, {'ForeName': 'Kuo-Hsiung', 'Initials': 'KH', 'LastName': 'Shu', 'Affiliation': 'Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Hok-King Lo', 'Affiliation': 'Department of Medicine, Pamela Youde Nethersole Eastern Hospital, Chai Wan, Hong Kong.'}, {'ForeName': 'Masanao', 'Initials': 'M', 'LastName': 'Isono', 'Affiliation': 'Toray Industries, Inc., Tokyo, Japan.'}, {'ForeName': 'Hajimu', 'Initials': 'H', 'LastName': 'Kurumatani', 'Affiliation': 'Toray Industries, Inc., Tokyo, Japan.'}, {'ForeName': 'Kiyonobu', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'Toray Industries, Inc., Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kanoh', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kiriyama', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'The University of Tokyo, Tokyo, Japan.'}]","Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy",['10.1111/1744-9987.12840']
523,28826348,Home-Based and Technology-Centered Childhood Obesity Prevention for Chinese Mothers With Preschool-Aged Children.,"INTRODUCTION


Nearly a quarter of preschool-aged Chinese American children are overweight or obese. Children of overweight mothers are at higher risk for obesity. Efforts to prevent obesity among low-income minority children with overweight mothers should start in early childhood.
METHODOLOGY


This randomized pilot study consisted of 8 weekly sessions, examined feasibility of a tablet computer-based intervention among 32 mother-child dyads. The study estimated effect size of the intervention at baseline, 3 and 6 months on maternal outcomes including self-efficacy, eating behaviors, physical activity, child-feeding practices, and change in body mass index.
RESULTS


The tablet computer-based intervention is feasible among low-income Chinese mothers with low acculturation. A large-effect size was observed in reducing maternal body mass index, waist circumference, and improving maternal eating style and self-efficacy for promoting healthy eating.
DISCUSSION


Multimedia tablet-based education tailored for Chinese immigrant mothers was successful in short-term maternal behaviors changes related to diet and exercise.",2017,"DISCUSSION


Multimedia tablet-based education tailored for Chinese immigrant mothers was successful in short-term maternal behaviors changes related to diet and exercise.","['low-income Chinese mothers with low acculturation', 'Chinese immigrant mothers', 'preschool-aged Chinese American children are overweight or obese', '32 mother-child dyads', 'Children of overweight mothers', 'Chinese Mothers With Preschool-Aged Children']","['tablet computer-based intervention', 'Home-Based and Technology-Centered Childhood Obesity Prevention']","['maternal body mass index, waist circumference, and improving maternal eating style and self-efficacy', 'maternal outcomes including self-efficacy, eating behaviors, physical activity, child-feeding practices, and change in body mass index']","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0000943', 'cui_str': 'Acculturation'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0008121', 'cui_str': 'Chinese Americans'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}]","[{'cui': 'C4045980', 'cui_str': 'Tablet Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0259406,"DISCUSSION


Multimedia tablet-based education tailored for Chinese immigrant mothers was successful in short-term maternal behaviors changes related to diet and exercise.","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sun', 'Affiliation': '1 Chinese Community Health Resource Center, San Francisco, CA, USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': '1 Chinese Community Health Resource Center, San Francisco, CA, USA.'}, {'ForeName': 'Quynh', 'Initials': 'Q', 'LastName': 'Bui', 'Affiliation': '2 Kaiser Permanente, Oakland, CA, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': '1 Chinese Community Health Resource Center, San Francisco, CA, USA.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Ng', 'Affiliation': '1 Chinese Community Health Resource Center, San Francisco, CA, USA.'}, {'ForeName': 'Jyu-Lin', 'Initials': 'JL', 'LastName': 'Chen', 'Affiliation': '3 University of California, San Francisco, CA, USA.'}]",Journal of transcultural nursing : official journal of the Transcultural Nursing Society,['10.1177/1043659617719139']
524,31117882,Catheter-directed foam sclerotherapy with tumescence of the great saphenous vein versus ultrasound-guided foam sclerotherapy: A randomized controlled trial.,,2020,"CONCLUSIONS


Catheter-directed foam sclerotherapy with tumescence was better than usual ultrasound-guided foam sclerotherapy as it reached higher full success rate of the treated great saphenous vein and as a lower number of patients required retreatment sessions in the short-term.","['Fifty subjects with varicose veins, edema, and great saphenous vein incompetence (diameter 6-10 mm']","['sclerotherapy techniques: A (usual ultrasound-guided) and B (catheter-directed with tumescence', 'Concomitant phlebectomy', 'Catheter-directed foam sclerotherapy with tumescence of the great saphenous vein versus ultrasound-guided foam sclerotherapy']","['Complication rates', 'full success rate of the treated great saphenous vein and the number of patients who required retreatment sessions', 'full success rates of the treated great saphenous vein', 'Quality of life', 'success rates', 'quality of life', 'quality of life and side effects and complications of the intervention', 'Full success rate of the treated great saphenous vein']","[{'cui': 'C0042345', 'cui_str': 'Varices'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency (finding)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}]","[{'cui': 'C0036435', 'cui_str': 'Sclerotherapy'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0191017', 'cui_str': 'Excision of vein (procedure)'}, {'cui': 'C0991510', 'cui_str': 'Foam (basic dose form)'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0034380'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",50.0,0.150346,"CONCLUSIONS


Catheter-directed foam sclerotherapy with tumescence was better than usual ultrasound-guided foam sclerotherapy as it reached higher full success rate of the treated great saphenous vein and as a lower number of patients required retreatment sessions in the short-term.","[{'ForeName': 'Jorgete B', 'Initials': 'JB', 'LastName': 'Dos Santos', 'Affiliation': 'Department of Surgery, Vascular and Endovascular Division, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Walter Campos', 'Initials': 'WC', 'LastName': 'Júnior', 'Affiliation': 'Department of Surgery, Vascular and Endovascular Division, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rina Mp', 'Initials': 'RM', 'LastName': 'Porta', 'Affiliation': 'Department of Surgery, Vascular and Endovascular Division, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Puggina', 'Affiliation': 'Department of Surgery, Vascular and Endovascular Division, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela Ft', 'Initials': 'DF', 'LastName': 'da Silva', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho/UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Puech-Leão', 'Affiliation': 'Department of Surgery, Vascular and Endovascular Division, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'de Luccia', 'Affiliation': 'Department of Surgery, Vascular and Endovascular Division, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Erasmo S', 'Initials': 'ES', 'LastName': 'da Silva', 'Affiliation': 'Department of Surgery, Vascular and Endovascular Division, Universidade de São Paulo, São Paulo, Brazil.'}]",Phlebology,['10.1177/0268355519850651']
525,31641005,Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol.,"INTRODUCTION


Hypertensive disorders of pregnancy continue to be a major contributor to maternal and perinatal morbidity and mortality. Magnesium sulfate therapy is the standard of care for seizure prophylaxis and treatment for pre-eclampsia and eclampsia respectively, despite wide disparities in dosing regimens and routes of administration. This study compares the clinical efficacy of magnesium sulfate in the reduction of seizure occurrence or recurrence with the 12 hours versus 24 hours modified Pritchard regimens in the management of severe pre-eclampsia and eclampsia.
METHODS AND ANALYSIS


This study is an open labelled randomised controlled trial. The study participants are patients admitted to the Korle Bu Teaching Hospital (KBTH) in Accra, Ghana with a diagnosis of antepartum, intrapartum or postpartum eclampsia or pre-eclampsia with severe features. All study participants will be administered a loading dose of magnesium sulfate, followed by maintenance dosing. Participants in the control group will receive magnesium sulfate for 24 hours after diagnosis, while those in the treatment group will receive magnesium sulfate for 12 hours after diagnosis. The primary outcome of this study is the occurrence of a seizure any time after the completion of treatment in the assigned group. Secondary outcome measures include maternal health outcomes, magnesium sulfate toxicities and fetal health outcomes. Data collection was started in October 2018 with a target enrolment of 1245 participants with severe pre-eclampsia and 844 participants with eclampsia with a projected study period of 2-3 years.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the KBTH Institutional Review Board (IRB) in Ghana. University of Michigan involvement is limited to protocol development and statistical analysis of de-identified data, and has been granted a Not Regulated Determination by the University of Michigan IRB. Results of the study will be shared at clinical forums at the KBTH and will be submitted for publication in an international peer-reviewed journal.
TRIAL REGISTRATION NUMBER


Pan African Clinical Trial Registry through the South African Medical Research Council (PACTR201811515303983).",2019,The primary outcome of this study is the occurrence of a seizure any time after the completion of treatment in the assigned group.,"['October 2018 with a target enrolment of 1245 participants with severe pre-eclampsia and 844 participants with eclampsia with a projected study period of 2-3 years', 'eclampsia and pre-eclampsia in Ghana (MOPEP Study', 'participants are patients admitted to the Korle Bu Teaching Hospital (KBTH) in Accra, Ghana with a diagnosis of antepartum, intrapartum or postpartum eclampsia or pre-eclampsia with severe features']","['Magnesium sulfate therapy', 'magnesium sulfate']","['maternal health outcomes, magnesium sulfate toxicities and fetal health outcomes', 'seizure occurrence or recurrence', 'occurrence of a seizure any time']","[{'cui': 'C0341950', 'cui_str': 'Severe pre-eclampsia (disorder)'}, {'cui': 'C0013537', 'cui_str': 'Eclampsia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0456336', 'cui_str': 'Antepartum (qualifier value)'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum (qualifier value)'}, {'cui': 'C0156678', 'cui_str': 'Eclampsia in puerperium (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",1245.0,0.147551,The primary outcome of this study is the occurrence of a seizure any time after the completion of treatment in the assigned group.,"[{'ForeName': 'Titus', 'Initials': 'T', 'LastName': 'Beyuo', 'Affiliation': 'Obstetrics and Gynaecology, University of Ghana School of Medicine and Dentistry, Accra, Ghana.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Lawrence', 'Affiliation': 'Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan, USA emmarl@med.umich.edu.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Langen', 'Affiliation': 'Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Samuel A', 'Initials': 'SA', 'LastName': 'Oppong', 'Affiliation': 'Obstetrics and Gynaecology, University of Ghana School of Medicine and Dentistry, Accra, Ghana.'}]",BMJ open,['10.1136/bmjopen-2019-032799']
526,31124422,Improving Adherence to Ticagrelor in Patients After Acute Coronary Syndrome: Results from the PROGRESS Trial.,"BACKGROUND


Dual antiplatelet therapy (DAPT) with aspirin and ticagrelor is recommended for at least 12 months in patients after an acute coronary syndrome (ACS). However, its underuse and premature discontinuation are common in clinical practice. We aimed to investigate the impact of a dedicated follow-up strategy with clinical visits and counselling on adherence levels to ticagrelor in patients after ACS.
METHODS


PROGRESS (PROmotinG dual antiplatelet therapy adheREnce in the setting of acute coronary Syndromes) is a prospective, randomized trial enrolling 400 ACS patients treated with ticagrelor. Patients were randomized to be followed-up in a dedicated outpatient clinic (In-person follow-up group, [IN-FU], n=200), or with scheduled for phone interviews only (Telephone follow-up group [TEL-FU], n=200), to assess ticagrelor adherence and related complications. DAPT disruption was defined as an interruption of the administration of the drug due to complications or other reasons of non-adherence, and divided according to the duration into short (1-5 days), temporary (6-30 days) and permanent (≥30 days) disruption. The primary endpoint was the rate of DAPT disruption at 1-year follow-up.
RESULTS


The rate of ticagrelor disruption at 1 year follow-up was higher in the TEL-FU group than in the IN-FU group (19.6 vs 5.5%; p<0.0001). The IN-FU group reported a significantly lower rate of short (3.0 vs 8.5%; p=0.012) and permanent (2.0 vs 9.6%; p=0.012) disruption than TEL-FU group. The rate of major bleeding did not differ significantly between the 2 groups (p=0.450).
CONCLUSION


The PROGRESS trial showed a net reduction in DAPT disruption in patients followed-up with clinical (in-person) follow-up visits in a dedicated outpatient clinic compared with those scheduled for phone interviews only.",2020,The rate of ticagrelor disruption at 1-year follow-up was higher in the TEL-FU group than in the IN-FU group (19.6 vs. 5.5%; p<0.0001).,"['patients after ACS', 'patients after acute coronary syndrome', 'patients after an acute coronary syndrome (ACS', '400 ACS patients treated with']","['TEL-FU', 'aspirin and ticagrelor', 'dedicated outpatient clinic (In-person follow-up group, [IP-FU], n=200), or with scheduled for phone interviews only (Telephone follow-up group [TEL-FU', 'ticagrelor', 'Ticagrelor']","['rate of DAPT disruption', 'rate of major bleeding', 'DAPT disruption', 'ticagrelor adherence and related complications', 'rate of ticagrelor disruption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}]","[{'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",400.0,0.0896679,The rate of ticagrelor disruption at 1-year follow-up was higher in the TEL-FU group than in the IN-FU group (19.6 vs. 5.5%; p<0.0001).,"[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Crisci', 'Affiliation': 'Department of Cardiology, Division of Interventional Cardiology, A.O.R.N. dei Colli - Monaldi Hospital, Naples, Italy.'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Gragnano', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Di Maio', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Diana', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Moscarella', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Pariggiano', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Di Maio', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Concilio', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Taglialatela', 'Affiliation': 'Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Fimiani', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Cesaro', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}, {'ForeName': 'Plinio L', 'Initials': 'PL', 'LastName': 'Cirillo', 'Affiliation': 'Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Calabrò', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}]",Current vascular pharmacology,['10.2174/1570161117666190524123225']
527,31133457,Fully closed-loop insulin delivery improves glucose control of inpatients with type 2 diabetes receiving hemodialysis.,"Inpatient diabetes management of those on hemodialysis poses a major challenge. In a post hoc analysis of a randomized controlled clinical trial, we compared the efficacy of fully automated closed-loop insulin delivery vs. usual care in patients undergoing hemodialysis while in hospital. Compared to control patients receiving conventional subcutaneous insulin therapy, those patients receiving closed-loop insulin delivery significantly increased the proportion of time when a continuous glucose monitor was in the target range of 5.6-10.0 mmol/l by 37.6 percent without increasing the risk of hypoglycemia. Thus, closed-loop insulin delivery offers a novel way to achieve effective and safe glucose control in this vulnerable patient population.",2019,"Compared to control patients receiving conventional subcutaneous insulin therapy, those patients receiving closed-loop insulin delivery significantly increased the proportion of time when a continuous glucose monitor was in the target range of 5.6-10.0 mmol/l by 37.6 percent without increasing the risk of hypoglycemia.","['inpatients with type 2 diabetes receiving hemodialysis', 'patients undergoing hemodialysis while in hospital']","['conventional subcutaneous insulin therapy', 'fully automated closed-loop insulin delivery vs. usual care', 'Fully closed-loop insulin delivery']","['risk of hypoglycemia', 'proportion of time when a continuous glucose monitor']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]",,0.0225244,"Compared to control patients receiving conventional subcutaneous insulin therapy, those patients receiving closed-loop insulin delivery significantly increased the proportion of time when a continuous glucose monitor was in the target range of 5.6-10.0 mmol/l by 37.6 percent without increasing the risk of hypoglycemia.","[{'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Bally', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition & Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Gubler', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition & Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Hood', 'Initials': 'H', 'LastName': 'Thabit', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Manchester University Hospitals NHS Foundation, Manchester Academic Health Science Centre, Manchester, UK; Division of Diabetes, Endocrinology and Gastroenterology, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hartnell', 'Affiliation': 'Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Ruan', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, UK.'}, {'ForeName': 'Malgorzata E', 'Initials': 'ME', 'LastName': 'Wilinska', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Department of Paediatrics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Evans', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Semmo', 'Affiliation': 'Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vogt', 'Affiliation': 'Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Coll', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stettler', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition & Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hovorka', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Department of Paediatrics, University of Cambridge, Cambridge, UK. Electronic address: rh347@cam.ac.uk.'}]",Kidney international,['10.1016/j.kint.2019.03.006']
528,31129929,Biomarker guidance allows a more personalized allocation of patients for remote patient management in heart failure: results from the TIM-HF2 trial.,"AIMS


The TIM-HF2 study showed less days lost due to unplanned cardiovascular hospitalization or all-cause death and improved survival in patients randomly assigned to remote patient management (RPM) instead of standard of care.
METHODS AND RESULTS


This substudy explored whether the biomarkers mid-regional pro-adrenomedullin (MR-proADM) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) could be used to identify low-risk patients unlikely to benefit from RPM, thereby allowing more efficient allocation of the intervention. For 1538 patients of the trial (median age 73 years, interquartile range 64-78 years, 30% female), baseline biomarkers were used to select subpopulations recommended for RPM with various safety endpoints (100%, 98%, 95% sensitivity), and efficacy of RPM was assessed. Both biomarkers were strongly associated with events. The primary endpoint of lost days increased from 1.0% (1.4%) in the lowest to 17.3% (17.6%) in the highest quintile of NT-proBNP (MR-proADM). After combining biomarkers to identify patients recommended for RPM with 95% sensitivity, in the most efficient scenario (excluding 27% of patients; NT-proBNP < 413.7 pg/mL and MR-proADM < 0.75 nmol/L), the effect of RPM on patients was highly similar to the original trial (ratio of lost days: 0.78, hazard ratio for all-cause death: 0.68). Number needed to treat for all-cause death was lowered from 28 to 21. Rates of emergencies and telemedical efforts were significantly lower among patients not recommended for RPM. Biomarker guidance would have saved about 150 h effort/year per 100 patients of the eligible population.
CONCLUSIONS


The combined use of MR-proADM and NT-proBNP may allow safe, more precise, effective and cost-saving allocation of patients with heart failure to RPM and warrants further prospective studies.",2019,Rates of emergencies and telemedical efforts were significantly lower among patients not recommended for RPM.,"['1538 patients of the trial (median age 73\u2009years, interquartile range 64-78\u2009years, 30% female', 'patients for remote patient management in heart failure', 'patients with heart failure to RPM']","['biomarkers mid-regional pro-adrenomedullin (MR-proADM) and N-terminal pro-B-type natriuretic peptide (NT-proBNP', 'MR-proADM and NT-proBNP']","['efficacy of RPM', 'Rates of emergencies and telemedical efforts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0582523', 'cui_str': 'rpm'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0215825', 'cui_str': 'Adrenomedullin (1-52)'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}]","[{'cui': 'C0582523', 'cui_str': 'rpm'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}]",,0.110128,Rates of emergencies and telemedical efforts were significantly lower among patients not recommended for RPM.,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Möckel', 'Affiliation': 'Division of Emergency and Acute Medicine, Cardiovascular Process Research, Campus Mitte and Virchow, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Koehler', 'Affiliation': 'Centre for Cardiovascular Telemedicine, Department of Cardiology and Angiology, Campus Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK) and Berlin Institute of Health, Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) partner site Berlin Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jörn', 'Initials': 'J', 'LastName': 'Vollert', 'Affiliation': 'Clinical Diagnostics, Thermo Fisher Scientific, Hennigsdorf, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Moeller', 'Affiliation': 'Centre for Cardiovascular Telemedicine, Department of Cardiology and Angiology, Campus Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Koehler', 'Affiliation': 'Technical University Munich, Department of Prevention, Rehabilitation and Sports Medicine, Ludwig-Maximilians-Universität, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Gehrig', 'Affiliation': 'Clinical Diagnostics, Thermo Fisher Scientific, Hennigsdorf, Germany.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Wiemer', 'Affiliation': 'Clinical Diagnostics, Thermo Fisher Scientific, Hennigsdorf, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'von Haehling', 'Affiliation': 'Department of Cardiology and Pneumology, Universitätsmedizin Göttingen, Göttingen, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Koehler', 'Affiliation': 'Centre for Cardiovascular Telemedicine, Department of Cardiology and Angiology, Campus Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}]",European journal of heart failure,['10.1002/ejhf.1530']
529,31753429,The Electrical Isolation of the Left Atrial Posterior Wall in Catheter Ablation of Persistent Atrial Fibrillation.,"OBJECTIVES


This study explored whether complete electrical isolation of the left atrial (LA) posterior wall improves the rhythm outcome of catheter ablation of persistent atrial fibrillation (AF).
BACKGROUND


Although the STAR AF2 (Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial Part II) proved no additional benefit of empirical extra-pulmonary vein (PV) LA ablation, the long-term recurrence rate after circumferential PV isolation (CPVI) alone remains high.
METHODS


We randomly assigned 217 patients with persistent AF (83.1% men, age 58.7 ± 10.8 years, 73.3% long-standing persistent AF) to ablation with CPVI alone (CPVI group) or CPVI with a POsterior wall Box Isolation (POBI group). The endpoint of the POBI group was the elimination of the posterior atrial potentials by roof and posterior inferior lines and touch-up focal ablation.
RESULTS


After a mean follow-up of 16.2 ± 8.8 months, the clinical recurrence rate did not significantly differ between the 2 groups (23.8% vs. 26.5%; p = 0.779) in the CPVI and POBI groups. The recurrence rate for atrial tachycardias (16.0% vs. 11.1%; p = 0.913) and cardioversion rates (6.7% vs. 13.7%; p = 0.093) to control clinical recurrences also did not significantly differ between the 2 groups. At the final follow-up, sinus rhythm was maintained without antiarrhythmic drug in 50.5% and 55.9% in the CPVI and POBI groups, respectively (p = 0.522). No significant difference was found in the major complication rates between the 2 groups, but the total ablation time was significantly longer in the POBI group (4,289 ± 1,837 s vs. 5,365 ± 2,358 s; p < 0.001).
CONCLUSIONS


In patients with persistent AF, an empirical complete POBI did not improve the rhythm outcome of catheter ablation or influence the type of recurrent atrial arrhythmia. (Comparison of Circumferential Pulmonary Vein Isolation Alone Versus Linear Ablation in Addition to Circumferential Pulmonary Vein Isolation for Catheter Ablation in Persistent Atrial Fibrillation: Prospective Randomized Controlled Trial; NCT02721121).",2019,"No significant difference was found in the major complication rates between the 2 groups, but the total ablation time was significantly longer in the POBI group (4,289 ± 1,837 s vs. 5,365 ± 2,358 s;","['Persistent Atrial Fibrillation', '217 patients with persistent AF (83.1% men, age 58.7 ± 10.8 years, 73.3% long-standing persistent AF) to ablation with CPVI alone (CPVI group) or CPVI with a POsterior wall Box Isolation (POBI group']","['Circumferential Pulmonary Vein Isolation', 'Alone Versus Linear Ablation in Addition to Circumferential Pulmonary Vein Isolation for Catheter Ablation', 'STAR AF2 (Substrate and Trigger Ablation']","['cardioversion rates', 'elimination of the posterior atrial potentials by roof and posterior inferior lines and touch-up focal ablation', 'total ablation time', 'major complication rates', 'clinical recurrence rate', 'rhythm outcome of catheter ablation', 'control clinical recurrences', 'recurrence rate for atrial tachycardias']","[{'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442071', 'cui_str': 'Posterior wall (qualifier value)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0220862', 'cui_str': 'isolation'}]","[{'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0878311', 'cui_str': 'AF-2'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}]","[{'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0557685', 'cui_str': 'Roof'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0546959', 'cui_str': 'Atrial tachycardia (disorder)'}]",217.0,0.0326653,"No significant difference was found in the major complication rates between the 2 groups, but the total ablation time was significantly longer in the POBI group (4,289 ± 1,837 s vs. 5,365 ± 2,358 s;","[{'ForeName': 'Jung Myung', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Kyung Hee University Medical College, Seoul, Republic of Korea.'}, {'ForeName': 'Jaemin', 'Initials': 'J', 'LastName': 'Shim', 'Affiliation': 'Korea University Cardiovascular Center, Seoul, Republic of Korea.'}, {'ForeName': 'Junbeom', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Ewha Womans University, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Tae', 'Initials': 'HT', 'LastName': 'Yu', 'Affiliation': 'Yonsei University Health System, Seoul, Republic of Korea.'}, {'ForeName': 'Tae-Hoon', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Yonsei University Health System, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Kyu', 'Initials': 'JK', 'LastName': 'Park', 'Affiliation': 'Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Sun', 'Initials': 'JS', 'LastName': 'Uhm', 'Affiliation': 'Yonsei University Health System, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Bae', 'Initials': 'JB', 'LastName': 'Kim', 'Affiliation': 'Kyung Hee University Medical College, Seoul, Republic of Korea.'}, {'ForeName': 'Boyoung', 'Initials': 'B', 'LastName': 'Joung', 'Affiliation': 'Yonsei University Health System, Seoul, Republic of Korea.'}, {'ForeName': 'Moon-Hyoung', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Yonsei University Health System, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Hoon', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Korea University Cardiovascular Center, Seoul, Republic of Korea.'}, {'ForeName': 'Hui-Nam', 'Initials': 'HN', 'LastName': 'Pak', 'Affiliation': 'Yonsei University Health System, Seoul, Republic of Korea. Electronic address: hnpak@yuhs.ac.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2019.08.021']
530,31116017,Development of an audio and computer cognitive behavioral therapy for depression in older adults.,"Background:  The purpose of this paper is to discuss the development of two novel technology-based interventions for depression in older adults while comparing older adults' preferences for audio-based and computer-based cognitive behavioral therapy for depressive symptoms. The audio program consisted of eight compact discs and a workbook while the computer program consisted of 11 modules of similar duration provided on a tablet PC. Both interventions consisted of the following topics: 1) introduction, 2) identifying and changing unhelpful thoughts, 3) addressing feelings, 4) relaxation, 5) engaging in pleasant events, 6) assertiveness, and 7) problem-solving.  Methods :  Fifty-one older adults were recruited from medical settings and rural communities and randomly assigned to an immediate treatment group (computer or audio) with minimal contact or a four-week minimal contact delayed treatment control condition. Results: Participants rated computer-based and audio-based cognitive behavioral therapy fairly equally, with 75% of those who received audio treatment and 85% of those who received computer-based treatment indicating benefits to their mood. Discussion :  Computer-based or audio-based cognitive behavioral treatments may be valuable, low-cost modalities to deliver psychotherapy to older adults with depressive symptoms within a health care setting. Both modalities seem to be accepted by older adults.",2020,"Participants rated computer-based and audio-based cognitive behavioral therapy fairly equally, with 75% of those who received audio treatment and 85% of those who received computer-based treatment indicating benefits to their mood.  ","['older adults with depressive symptoms within a health care setting', 'Methods :  Fifty-one older adults were recruited from medical settings and rural communities', 'older adults']","['audio-based and computer-based cognitive behavioral therapy', 'audio and computer cognitive behavioral therapy', 'immediate treatment group (computer or audio) with minimal contact or a four-week minimal contact delayed treatment control condition', 'computer-based and audio-based cognitive behavioral therapy', 'introduction, 2) identifying and changing unhelpful thoughts, 3) addressing feelings, 4) relaxation, 5) engaging in pleasant events, 6) assertiveness, and 7) problem-solving', 'Computer-based or audio-based cognitive behavioral treatments', 'audio program consisted of eight compact discs and a workbook while the computer program consisted of 11 modules of similar duration provided on a tablet PC']",[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3693346', 'cui_str': 'Delayed Treatment'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0004077', 'cui_str': 'Assertivenesses'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0079141'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]",[],51.0,0.0125774,"Participants rated computer-based and audio-based cognitive behavioral therapy fairly equally, with 75% of those who received audio treatment and 85% of those who received computer-based treatment indicating benefits to their mood.  ","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Morthland', 'Affiliation': 'VAMC Tuscaloosa, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Avani', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'School of Social Work, University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Meadows', 'Affiliation': 'School of Social Work, University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Forrest', 'Initials': 'F', 'LastName': 'Scogin', 'Affiliation': 'Psychology Department, University of Alabama, Tuscaloosa, Alabama, USA.'}]",Aging & mental health,['10.1080/13607863.2019.1609901']
531,31078482,Outcomes and Effect of Treatment According to Etiology in HFrEF: An Analysis of PARADIGM-HF.,"OBJECTIVES


The purpose of this study was to compare outcomes (and the effect of sacubitril/valsartan) according to etiology in the PARADIGM-HF (Prospective comparison of angiotensin-receptor-neprilysin inhibitor [ARNI] with angiotensin-converting-enzyme inhibitor [ACEI] to Determine Impact on Global Mortality and morbidity in Heart Failure) trial.
BACKGROUND


Etiology of heart failure (HF) has changed over time in more developed countries and is also evolving in non-Western societies. Outcomes may vary according to etiology, as may the effects of therapy.
METHODS


We examined outcomes and the effect of sacubtril/valsartan according to investigator-reported etiology in PARADIGM-HF. The outcomes analyzed were the primary composite of cardiovascular death or HF hospitalization, and components, and death from any cause. Outcomes were adjusted for known prognostic variables including N terminal pro-B type natriuretic peptide.
RESULTS


Among the 8,399 patients randomized, 5,036 patients (60.0%) had an ischemic etiology. Among the 3,363 patients (40.0%) with a nonischemic etiology, 1,595 (19.0% of all patients; 47% of nonischemic patients) had idiopathic dilated cardiomyopathy, 968 (11.5% of all patients; 28.8% of nonischemic patients) had a hypertensive cause, and 800 (9.5% of all patients, 23.8% of nonischemic patients) another cause (185 infective/viral, 158 alcoholic, 110 valvular, 66 diabetes, 30 drug-related, 14 peripartum-related, and 237 other). Whereas the unadjusted rates of all outcomes were highest in patients with an ischemic etiology, the adjusted hazard ratios (HRs) were not different from patients in the 2 major nonischemic etiology categories; for example, for the primary outcome, compared with ischemic (HR: 1.00), hypertensive 0.87 (95% confidence interval [CI]: 0.75 to 1.02), idiopathic 0.92 (95% CI: 0.82 to 1.04) and other 1.00 (95% CI: 0.85 to 1.17). The benefit of sacubitril/valsartan over enalapril was consistent across etiologic categories (interaction for primary outcome; p = 0.11).
CONCLUSIONS


Just under one-half of patients in this global trial had nonischemic HF with reduced ejection fraction, with idiopathic and hypertensive the most commonly ascribed etiologies. Adjusted outcomes were similar across etiologic categories, as was the benefit of sacubitril/valsartan over enalapril. (Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure; NCT01035255).",2019,"Whereas the unadjusted rates of all outcomes were highest in patients with an ischemic etiology, the adjusted hazard ratios (HRs) were not different from patients in the 2 major nonischemic etiology categories; for example, for the primary outcome, compared with ischemic (HR: 1.00), hypertensive 0.87","['Patients With Chronic Heart\xa0Failure', 'another cause (185 infective/viral, 158 alcoholic, 110 valvular, 66 diabetes, 30 drug-related, 14 peripartum-related, and 237 other', '8,399 patients randomized, 5,036 patients (60.0%) had an ischemic etiology']","['enalapril', 'angiotensin-receptor-neprilysin inhibitor [ARNI', 'Enalapril', 'angiotensin-converting-enzyme inhibitor [ACEI', 'sacubitril/valsartan', 'LCZ696', 'sacubtril/valsartan']","['idiopathic dilated cardiomyopathy', 'hypertensive cause', 'cardiovascular death or HF hospitalization, and components, and death from any cause', 'Morbidity and Mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0687725', 'cui_str': 'Alcoholics'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C2936491', 'cui_str': 'Peripartum'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0015127', 'cui_str': 'causes'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}, {'cui': 'C0025250', 'cui_str': 'CALLA Antigen'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C2933615', 'cui_str': 'LCZ 696'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}]","[{'cui': 'C1449563', 'cui_str': 'Cardiomyopathy, Dilated, LMNA'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",8399.0,0.177835,"Whereas the unadjusted rates of all outcomes were highest in patients with an ischemic etiology, the adjusted hazard ratios (HRs) were not different from patients in the 2 major nonischemic etiology categories; for example, for the primary outcome, compared with ischemic (HR: 1.00), hypertensive 0.87","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Balmforth', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Simpson', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lefkowitz', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Adel R', 'Initials': 'AR', 'LastName': 'Rizkala', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Heart Institute and University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Shi', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina and Ralph H. Johnson Veterans Administration Medical Center, Charleston, South Carolina.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom. Electronic address: john.mcmurray@glasgow.ac.uk.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.02.015']
532,31090170,Potential Effects of Telbivudine Versus Entecavir on Renal Function in Patients With Chronic Hepatitis B Virus Receiving Glucocorticoids Therapy.,"Data remains limited about the optimal nucleos(t)ide analogue therapy for patients infected with hepatitis B virus (HBV) while treated with glucocorticoids because of kidney diseases. We aim to evaluate the safety and efficacy of long-term antiviral therapy with telbivudine (LdT) and entecavir (ETV) in this specific population. In this prospective randomized controlled study, a total of 60 patients with both kidney diseases and chronic hepatitis B were randomly divided into LdT group and ETV group. We analyzed changes in estimated glomerular filtration rate (eGFR), variation in HBV DNA, seroconversion of hepatitis B e antigen (HbeAg) and hepatitis B surface antigen (HBsAg). During the 18 month follow-up period, serum HBV DNA load was decreased significantly at 3, 6, 12, 18 months, compared to the pre-treatment value in both LdT and ETV cohorts. No patients achieved HBeAg loss-seroconversion or HBsAg loss-seroconversion with ETV therapy whilst one patient experienced HBeAg and HBsAg loss-seroconversion with LdT therapy. No significant changes in eGFR were seen in patients with ETV therapy compared to baseline. However, eGFR increased 7.43, 18.97 mL/min/1.73m 2  , respectively at 12 and 18 months in LdT group and the changes were significant compared to baseline. Further analysis also demonstrated that eGFR significantly improved 11.8, 23.25 mL/min/1.73m 2  at 12 and 18 months in LdT group for patients with impaired renal function. LdT is superior to ETV in patients with chronic hepatitis B and kidney diseases because of the renal protection it confers by increasing eGFR.",2020,"However, eGFR increased 7.43 ml/min/1.73m 2  , 18.97 ml/min/1.73","['patients with chronic hepatitis B virus receiving glucocorticoids therapy', 'patients with CHB and kidney diseases', '60 patients with both kidney diseases and chronic hepatitis B (CHB', 'patients infected with hepatitis B virus (HBV']","['long- term antiviral therapy with telbivudine® (LdT) and entecavir® (ETV', 'glucocorticoids®', 'LdT', 'telbivudine versus entecavir', 'LdT group and ETV']","['safety and efficacy', 'HBeAg loss-seroconversion or HBsAg loss-seroconversion', 'eGFR', 'serum HBV DNA load', 'renal function', 'estimated glomerular filtration rate (eGFR), variation in HBV DNA , seroconversion of hepatitis B e antigen (HbeAg) and hepatitis B surface antigen (HBsAg']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0227665', 'cui_str': 'Both kidneys (body structure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy (procedure)'}, {'cui': 'C1453933', 'cui_str': 'telbivudine'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C3811844'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}]",60.0,0.0195251,"However, eGFR increased 7.43 ml/min/1.73m 2  , 18.97 ml/min/1.73","[{'ForeName': 'Baolian', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of the Army Medical University, Chongqing, China.'}, {'ForeName': 'Bingbing', 'Initials': 'B', 'LastName': 'Shen', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of the Army Medical University, Chongqing, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Mei', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of the Army Medical University, Chongqing, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of the Army Medical University, Chongqing, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, The First Affiliated Hospital of the Army Medical University, Chongqing, China.'}, {'ForeName': 'Hongwen', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of the Army Medical University, Chongqing, China.'}]","Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy",['10.1111/1744-9987.12839']
533,31012238,Home-based 'exergaming' was safe and significantly improved 6-min walking distance in patients with prostate cancer: a single-blinded randomised controlled trial.,"OBJECTIVES


To explore the effects of 12 weeks of unsupervised home-based 'exergaming' (i.e., technology-driven exercise) compared to usual care on physical function, body composition, quality of life (QoL), and fatigue in patients with prostate cancer on androgen-deprivation therapy (ADT).
PATIENTS AND METHODS


In an assessor-blinded randomised controlled trial, 46 patients with prostate cancer (aged >65 years) with locally advanced or advanced stage disease undergoing ADT were randomised to 12 weeks of unsupervised home-based exergaming or usual care from two hospitals in Denmark. The primary outcome of the study was 6-min walking test (6MWT). Secondary outcomes were leg extensor power (LEP), body composition (lean- and fat-mass), self-reported physical functioning and global health status (European Organisation for Research and Treatment of Cancer quality of life questionnaire 30-item core [EORTC QLQ-C30]), QoL (Functional Assessment of Cancer Therapy - Prostate [FACT-P]) and fatigue (FACT - fatigue [FACT-F]).
RESULTS


There was significant improvement in the exergaming group compared to the usual care group in the primary outcome of 6MWT (mean difference: 21.5 m; 95% confidence interval ([CI]) 3.2-39.9; P = 0.023). There were no differences between the groups for LEP (P = 0.227), lean body mass (P = 0.100), fat body mass (P = 0.092), self-reported physical functioning (P = 0.084) and global health status (P = 0.113), QoL (P = 0.614), and fatigue (P = 0.147).
CONCLUSION


Unsupervised home-based exergaming for 12 weeks had an effect on the primary outcome of 6MWT in patients with prostate cancer receiving ADT. However, no significant effects were found in secondary outcomes. The exergaming intervention appeared safe and could be an alternative to traditional aerobic and resistance training in this patient group.",2019,There was significant improvement in the exergaming group compared to the usual care group in the primary outcome of 6MWT (mean difference: 21.5 m; 95% confidence interval ([CI]) 3.2-39.9; P = 0.023).,"['patients with prostate cancer', '46 patients with prostate cancer (aged >65\xa0years) with locally advanced or advanced stage disease undergoing ADT', 'patients with prostate cancer on androgen-deprivation therapy (ADT', 'patients with prostate cancer receiving ADT']","['unsupervised home-based exergaming or usual care from two hospitals in Denmark', ""unsupervised home-based 'exergaming' (i.e., technology-driven exercise"", '6MWT']","['fat body mass', 'LEP', 'physical function, body composition, quality of life (QoL), and fatigue', 'fatigue', '6-min walking distance', 'QoL', 'self-reported physical functioning', '6-min walking test (6MWT', 'leg extensor power (LEP), body composition (lean- and fat-mass), self-reported physical functioning and global health status (European Organisation for Research and Treatment of Cancer quality of', 'global health status', 'life questionnaire 30-item core [EORTC QLQ-C30]), QoL (Functional Assessment of Cancer Therapy - Prostate', 'lean body mass']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0015665', 'cui_str': 'Fat Body'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0034380'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0035168'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}]",46.0,0.141047,There was significant improvement in the exergaming group compared to the usual care group in the primary outcome of 6MWT (mean difference: 21.5 m; 95% confidence interval ([CI]) 3.2-39.9; P = 0.023).,"[{'ForeName': 'Brigitta R', 'Initials': 'BR', 'LastName': 'Villumsen', 'Affiliation': 'Department of Urology, Regional Hospital Holstebro, Holstebro, Denmark.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Jorgensen', 'Affiliation': 'Center for PREdiction and prevention of FALLs (PREFALL), Department of Geriatrics, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Frystyk', 'Affiliation': 'Medical Research Laboratory, Department of Clinical Medicine, Faculty of Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Hørdam', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Borre', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health, Aarhus University, Aarhus, Denmark.'}]",BJU international,['10.1111/bju.14782']
534,31099258,Comparing sleep quality in institutionalized and non-institutionalized elderly individuals.,"Objectives:  Sleep is a physiological function essential to general health and well-being. Insomnia is a sleep disorder frequently reported by older adults. Institutionalization in nursing care homes may contribute to increase the risk of sleep disorders in this population. The aim of this exploratory study was to compare sleep quality among a group of institutionalized (GI) and a group of non-institutionalized (GNI) elderly individuals. Method:  We selected 100 individuals over 65 years of age. Participants were divided into two groups ( N  = 50 in each group) according to their institutionalization status (GI and GNI). The following assessment instruments were used: Pittsburgh Sleep Quality Inventory (PSQI), Epworth Sonolence Scale (ESS) and Geriatric Depression Scale (GDS). Study groups were compared in their sociodemographic, social and clinical characteristics with statistical analysis performed to detect correlations between variables. Results:  GI elderly presented worse overall sleep quality and higher levels of daytime somnolence and depressive symptoms. A positive correlation was found between sleep quality, daytime sleepiness (ESS) ( p  < 0.01) and depressive symptoms (GDS) ( p  < 0.01). Conclusions:  Our results are consistent with the possibility that elderly individuals admitted to long-term care and residential institutions present with worse sleep quality. Higher levels of depressive symptoms, lower occupational activity and sunlight exposure are specifically associated with a worse sleep quality. Further studies with larger and more diverse samples, including community-dwelling individuals, may be important to consolidate these findings.",2020,"A positive correlation was found between sleep quality, daytime sleepiness (ESS) (p < 0.01) and depressive symptoms (GDS) (p < 0.01).
","['a group of institutionalized (GI) and a group of non-institutionalized (GNI) elderly individuals', '100 individuals over 65 years of age', 'institutionalized and non-institutionalized elderly individuals']",[],"['sleep quality, daytime sleepiness (ESS', 'daytime somnolence and depressive symptoms', 'depressive symptoms, lower occupational activity and sunlight exposure', 'overall sleep quality', 'sleep quality', 'Pittsburgh Sleep Quality Inventory (PSQI), Epworth Sonolence Scale (ESS) and Geriatric Depression Scale (GDS', 'depressive symptoms (GDS']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C2219848', 'cui_str': 'Daytime somnolence'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0222045'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}]",100.0,0.0157573,"A positive correlation was found between sleep quality, daytime sleepiness (ESS) (p < 0.01) and depressive symptoms (GDS) (p < 0.01).
","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Martins da Silva', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Afonso', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Fonseca', 'Affiliation': 'Center for Mathematics and Applications, Faculty of Sciences and Technology, New University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Teodoro', 'Affiliation': 'Department of Psychiatry, Lisbon Psychiatric Hospital Centre, Lisbon, Portugal.'}]",Aging & mental health,['10.1080/13607863.2019.1619168']
535,29901486,Weight Loss Maintenance and Cellular Aging in the Supporting Health Through Nutrition and Exercise Study.,"OBJECTIVE


The aim of the study was to determine, within a weight loss clinical trial for obesity, the impact of intervention arm, weight change, and weight loss maintenance on telomere length (TL).
METHODS


Adults (N = 194) with a body mass index between 30 and 45 were randomized to a 5.5-month weight loss program with (n = 100) or without (n = 94) mindfulness training and identical diet-exercise guidelines. We assessed TL at baseline and 3-, 6-, and 12-month postbaseline in immune cell populations (primarily in peripheral blood mononuclear cells [PBMCs], but also in granulocytes and T and B lymphocytes). We defined weight loss maintenance as having lost at least 5% or 10% of body weight (tested in separate models) from preintervention to postintervention, and having maintained this loss at 12 months. We predicted that greater weight loss and weight loss maintenance would be associated with TL lengthening.
RESULTS


Neither weight loss intervention significantly predicted TL change nor did amount of weight change, at any time point. Across all participants, weight loss maintenance of at least 10% was associated with longer PBMC TL (b = 239.08, 95% CI = 0.92 to 477.25, p = .049), CD8+ TL (b = 417.26, 95% CI = 58.95 to 775.57, p = .023), and longer granulocyte TL (b = 191.56, 95% CI = -4.23 to 387.35, p = .055) at 12 months after accounting for baseline TL. Weight loss maintenance of 5% or more was associated with longer PBMC TL (b = 163.32, 95% CI = 4.00 to 320.62, p = .045) at 12 months after accounting for baseline TL. These tests should be interpreted in light of corrections for multiple tests.
CONCLUSIONS


Among individuals with obesity, losing and maintaining a weight loss of 10% or more may lead to TL lengthening, which may portend improved immune and metabolic function. TL lengthening in this study is of unknown duration beyond 12 months and requires further study.
TRIAL REGISTRATION


Clinicaltrials.govidentifierNCT00960414; Open Science Framework (OSF) preregistration: https://osf.io/t3r2g/.",2018,"Weight loss maintenance of 5% or more was associated with longer PBMC TL (b = 163.32, 95% CI = 4.00 to 320.62, p = .045) at 12 months after accounting for baseline TL.",['Adults (N = 194) with a body mass index between 30 and 45'],"['5.5-month weight loss program with (n = 100) or without (n = 94) mindfulness training and identical diet-exercise guidelines', 'TL lengthening']","['weight loss and weight loss maintenance', 'weight loss', 'weight change, and weight loss maintenance on telomere length (TL', 'CD8+ TL', 'granulocytes and T and B lymphocytes', 'longer PBMC TL', 'Weight loss maintenance', 'longer granulocyte TL', 'weight loss maintenance', 'weight change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0392744', 'cui_str': 'Lengthened (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0085187'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",194.0,0.0982356,"Weight loss maintenance of 5% or more was associated with longer PBMC TL (b = 163.32, 95% CI = 4.00 to 320.62, p = .045) at 12 months after accounting for baseline TL.","[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Mason', 'Affiliation': 'From the UCSF Department of Psychiatry (Mason, Schleicher, Prather, Epel), Center for Health and Community, San Francisco, California; UCSF Osher Center for Integrative Medicine (Mason, Hecht, Moran, Schleicher, Acree, Epel), San Francisco, California; Department of Health Education (Daubenmier), SF State University, Institute of Holistic Health Studies, San Francisco, California; Department of Psychology (Sbarra), The University of Arizona, Tucson; and UCSF Department of Biochemistry and Biophysics (Lin), San Francisco, California.'}, {'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Hecht', 'Affiliation': ''}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Daubenmier', 'Affiliation': ''}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Sbarra', 'Affiliation': ''}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Moran', 'Affiliation': ''}, {'ForeName': 'Samantha G', 'Initials': 'SG', 'LastName': 'Schleicher', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Acree', 'Affiliation': ''}, {'ForeName': 'Aric A', 'Initials': 'AA', 'LastName': 'Prather', 'Affiliation': ''}, {'ForeName': 'Elissa S', 'Initials': 'ES', 'LastName': 'Epel', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000616']
536,30979507,Effects of ventilation mode and manual chest compression on flow bias during the positive end- and zero end-expiratory pressure manoeuvre in mechanically ventilated patients: a randomised crossover trial.,"OBJECTIVES


To investigate the effects of ventilation mode and manual chest compression (MCC) application on the flow bias generated during positive end-expiratory pressure-zero end-expiratory pressure (PEEP-ZEEP) in mechanically ventilated patients. PEEP-ZEEP is an airway clearance manoeuvre with the potential to exceed the flow bias required to remove secretions. However, the ventilation mode applied during the manoeuvre has not been standardised.
DESIGN


Randomised crossover trial.
PARTICIPANTS


Nineteen mechanically ventilated patients.
INTERVENTIONS


Patients were randomised to receive PEEP-ZEEP in volume-controlled and pressure-controlled modes, and with or without MCC.
MAIN OUTCOME MEASURES


The difference in flow bias - assessed by the peak expiratory flow (PEF) and peak inspiratory flow (PIF) ratio and difference - between PEEP-ZEEP applied in both ventilation modes, and with and without MCC.
RESULTS


The expiratory flow bias was significantly higher in the volume-controlled mode than the pressure-controlled mode. This result was caused by a lower PIF in the volume-controlled mode. PEEP-ZEEP applied in the pressure-controlled mode did not achieve the PEF-PIF difference threshold to clear mucus. Moreover, in the majority of cycles of PEEP-ZEEP applied in the pressure-controlled mode, an inspiratory flow bias was generated, which might embed mucus. PEF was 8l/minute higher with MCC compared with without MCC, which increased the PEF-PIF difference by the same amount. No haemodynamic or respiratory adverse effects were found.
CONCLUSIONS


If applied in the volume-controlled mode, PEEP-ZEEP can achieve the flow bias needed to expel pulmonary secretions. However, this is not the case in the pressure-controlled mode. MCC can augment the flow bias generated by PEEP-ZEEP, but its application may be dispensable.
CLINICAL TRIAL REGISTRATION


http://www.ensaiosclinicos.gov.br/rg/RBR-223xv8/.",2020,"PEF was 8l/minute higher with MCC compared with without MCC, which increased the PEF-PIF difference by the same amount.","['mechanically ventilated patients', 'Nineteen mechanically ventilated patients']","['RBR-223xv8', 'ventilation mode and manual chest compression', 'PEEP-ZEEP', 'ventilation mode and manual chest compression (MCC', 'MCC', 'PEEP-ZEEP in volume-controlled and pressure-controlled modes, and with or without MCC']","['flow bias - assessed by the peak expiratory flow (PEF) and peak inspiratory flow (PIF) ratio', 'haemodynamic or respiratory adverse effects', 'PEF', 'PEF-PIF difference', 'expiratory flow bias', 'flow bias generated during positive end-expiratory pressure-zero end-expiratory pressure (PEEP-ZEEP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}]","[{'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C0449972', 'cui_str': 'Volume control (attribute)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0428720', 'cui_str': 'End-expiratory pressure'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}]",19.0,0.0347613,"PEF was 8l/minute higher with MCC compared with without MCC, which increased the PEF-PIF difference by the same amount.","[{'ForeName': 'B L R', 'Initials': 'BLR', 'LastName': 'Amaral', 'Affiliation': 'Department of Applied Physiotherapy, Federal University of Triângulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'de Figueiredo', 'Affiliation': 'Department of Applied Physiotherapy, Federal University of Triângulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Lorena', 'Affiliation': 'Multiprofessional Integrated Residency Program in Adult Health, Federal University of Triângulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'A C O', 'Initials': 'ACO', 'LastName': 'Oliveira', 'Affiliation': 'Multiprofessional Integrated Residency Program in Adult Health, Federal University of Triângulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Carvalho', 'Affiliation': 'Laboratory for Medical Research 09, Medical School, University of Sao Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Volpe', 'Affiliation': 'Department of Sciences of Human Movement, Federal University of São Paulo, Santos, SP, Brazil. Electronic address: marciasvolpe@gmail.com.'}]",Physiotherapy,['10.1016/j.physio.2018.12.007']
537,31733362,The Context of Values in Pain Control: Understanding the Price Effect in Placebo Analgesia.,"The experience of pain relief arises from physiological and psychological factors, and attributes such as the commercial features of analgesic treatments have been shown to influence placebo analgesia by affecting treatment expectations. Therefore, treatment valuation from price information should influence the placebo analgesic effect. This hypothesis was tested in a functional magnetic resonance imaging study in which healthy subjects were enrolled in a 2-day experiment. On day 1, the participants (n = 19) had treatment experiences with 2 different placebo creams during a conditioning session without receiving information on treatment price. On day 2, placebo analgesia was tested after providing price information (high vs low) while functional magnetic resonance imaging was performed. The results showed that the higher priced placebo treatment leads to enhanced pain relief. Placebo analgesia in response to the higher priced treatment was associated with activity in the ventral striatum, ventromedial prefrontal cortex, and ventral tegmental area. The behavioral results indicate that the experience of pain was influenced by treatment valuation from price. Our findings reveal that the context of values in pain control is associated with activity in expectation- and reward-related circuitry. PERSPECTIVE: Treatment with higher price was associated with enhanced placebo analgesia, and this effect was influenced by activities in expectation and reward processing brain areas. The context of value such as medical cost influences cognitive evaluation processes to modulate pain. Our study may help evaluate a patient's preference toward high-priced drugs.",2020,"Placebo analgesia in response to the higher priced treatment was associated with activity in the ventral striatum, ventromedial prefrontal cortex and ventral tegmental area.",['healthy subjects'],"['placebo', 'placebo analgesia', 'placebo creams', 'Placebo analgesia']","['pain relief', 'pain']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.152627,"Placebo analgesia in response to the higher priced treatment was associated with activity in the ventral striatum, ventromedial prefrontal cortex and ventral tegmental area.","[{'ForeName': 'Ye-Seul', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Acupuncture and Meridian Science Research Center, College of Korean Medicine, Kyung Hee University, Seoul, South Korea; Department of Anatomy and Acupoint, College of Korean Medicine, Gachon University, Seongnam, South Korea.'}, {'ForeName': 'Won-Mo', 'Initials': 'WM', 'LastName': 'Jung', 'Affiliation': 'Acupuncture and Meridian Science Research Center, College of Korean Medicine, Kyung Hee University, Seoul, South Korea.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Bingel', 'Affiliation': 'Department of Neurology, Essen University Hospital, Essen, Germany.'}, {'ForeName': 'Younbyoung', 'Initials': 'Y', 'LastName': 'Chae', 'Affiliation': 'Acupuncture and Meridian Science Research Center, College of Korean Medicine, Kyung Hee University, Seoul, South Korea; Department of Neurology, Essen University Hospital, Essen, Germany. Electronic address: ybchae@khu.ac.kr.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.11.005']
538,30982748,Hydrogen-rich water reduces liver fat accumulation and improves liver enzyme profiles in patients with non-alcoholic fatty liver disease: a randomized controlled pilot trial.,"BACKGROUND AND AIMS


While non-alcoholic fatty liver disease (NAFLD) is rapidly becoming the most common liver disease worldwide, its treatment remains elusive. Since metabolic impairment plays a major role in NAFLD pathogenesis, any pharmaceuticals, such as molecular hydrogen (H 2 ), that advance lipid and glucose metabolism could be appropriate to tackle this complex condition. The aim of this study was to analyze the effects of 28-day hydrogen-rich water intake on liver fat deposition, body composition and lab chemistry profiles in overweight patients suffering from mild-to-moderate NAFLD.
METHODS


Twelve overweight outpatients with NAFLD (age 56.2 ± 10.0 years; body mass index 37.7 ± 5.3 kg/m 2 ; 7 women and 5 men) voluntarily participated in this double-blind, placebo-controlled, crossover trial. All patients were allocated to receive either 1 L per day of hydrogen-rich water (HRW) or placebo water for 28 days. The study was registered at ClinicalTrials.gov (ID NCT03625362).
RESULTS


Dual-echo MRI revealed that HRW significantly reduced liver fat accumulation in individual liver regions-of-interest at 28-day follow-up, as compared to placebo administration (P < 0.05). Baseline liver fat content was reduced from 284.0 ± 118.1 mM to 256.5 ± 108.3 mM after hydrogen treatment at 28-day follow-up (percent change 2.9%; 95% CI from 0.5 to 5.5). Serum aspartate transaminase levels dropped by 10.0% (95% CI; from -23.2 to 3.4) after hydrogen treatment at 28-day follow-up. No significant differences were observed between treatment groups in either weight or body composition among participants.
CONCLUSIONS


Although preliminary, the results of this trial perhaps nominate HRW as an adjuvant treatment for mild-to-moderate NAFLD. These observations provide a rationale for further clinical trials to establish safety and efficacy of molecular hydrogen in NAFLD.",2019,Serum aspartate transaminase levels dropped by 10.0% (95% CI; from -23.2 to 3.4) after hydrogen treatment at 28-day follow-up.,"['Twelve overweight outpatients with NAFLD (age 56.2\u2009±\u200910.0 years; body mass index 37.7\u2009±\u20095.3\u2009kg/m 2 ; 7 women and 5 men) voluntarily participated', 'overweight patients suffering from mild-to-moderate NAFLD', 'patients with non-alcoholic fatty liver disease']","['28-day hydrogen-rich water intake', 'Hydrogen-rich water', 'placebo', '1\u2009L per day of hydrogen-rich water (HRW) or placebo']","['weight or body composition', 'liver fat deposition, body composition and lab chemistry profiles', 'liver enzyme profiles', 'Baseline liver fat content', 'Serum aspartate transaminase levels', 'liver fat accumulation']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0013123', 'cui_str': 'Water Intake'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439505', 'cui_str': 'per day'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0333562', 'cui_str': 'Deposition (morphologic abnormality)'}, {'cui': 'C0201682', 'cui_str': 'Chemistry NOS'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0428339', 'cui_str': 'Aspartate transaminase level (finding)'}]",12.0,0.276334,Serum aspartate transaminase levels dropped by 10.0% (95% CI; from -23.2 to 3.4) after hydrogen treatment at 28-day follow-up.,"[{'ForeName': 'Darinka', 'Initials': 'D', 'LastName': 'Korovljev', 'Affiliation': 'Applied Bioenergetics Lab, Faculty of Sport and PE, University of Novi Sad, Novi Sad, Serbia. Electronic address: dara.korovljev@uns.ac.rs.'}, {'ForeName': 'Valdemar', 'Initials': 'V', 'LastName': 'Stajer', 'Affiliation': 'Applied Bioenergetics Lab, Faculty of Sport and PE, University of Novi Sad, Novi Sad, Serbia. Electronic address: stajervaldemar@yahoo.com.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Ostojic', 'Affiliation': 'Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark. Electronic address: jelena.ostojic@rsyd.dk.'}, {'ForeName': 'Tyler W', 'Initials': 'TW', 'LastName': 'LeBaron', 'Affiliation': 'Molecular Hydrogen Institute, Kissimmee, FL, USA; Institute for Heart Research, Slovak Academy of Sciences, Bratislava, Slovak Republic. Electronic address: LeBaronT@molecularhydrogeninstitute.com.'}, {'ForeName': 'Sergej M', 'Initials': 'SM', 'LastName': 'Ostojic', 'Affiliation': 'Applied Bioenergetics Lab, Faculty of Sport and PE, University of Novi Sad, Novi Sad, Serbia; Faculty of Health Sciences, University of Pécs, Pécs, Hungary. Electronic address: sergej.ostojic@chess.edu.rs.'}]",Clinics and research in hepatology and gastroenterology,['10.1016/j.clinre.2019.03.008']
539,30962815,Investigating the effect of group counseling on family stress and anxiety of primiparous mothers during delivery.,"Background


Family is considered as the first source of care and support for the mother. Family stress and anxiety can be transmitted to the pregnant mother and have negative effects on pregnancy, childbirth, postpartum, and even their fetus. Given that one of the policies of the World Health Organization is to emphasize ""safe family is safe with mother"" this study was aimed to determine the effect of group counseling on family stress and anxiety of primiparous mothers during delivery.
Methods


This quasi-experimental study was conducted in 2016 on 72 family members of pregnant women who were referred to midwifery clinics in two health centers in Saveh-Iran. In this research, two members of each family (husband and other family of the pregnant woman) were selected using convenience sampling and were randomly divided into two groups of 36 families. At the beginning of the third trimester of pregnancy, standard questionnaires of Cohen's Perceived Stress and Cattell Anxiety scale were completed by both groups. For the intervention group, six sessions of cognitive group counseling were held weekly and the control group did not receive the intervention. Then, at the time of hospitalizing pregnant women for childbirth, the questionnaires were completed again by the family of both groups and the two groups were compared in terms of stress and anxiety before and after the intervention. Data were analyzed by SPSS software version 16 using appropriate statistical tests.
Findings


The findings showed that there was no significant difference between mean scores of stress, anxiety, hidden anxiety and obvious anxiety before intervention in both intervention and control groups. In the intervention group, Perceived stress score ( p  < 0.001), anxiety score ( p  < 0.001), hidden anxiety score ( p  = 0.003) and obvious anxiety score ( p  < 0.001) after intervention, with a statistically significant difference were lower than the control group.
Conclusion


Group counseling can reduce the stress and anxiety of the family of primiparous mothers.",2019,"In the intervention group, Perceived stress score ( p  < 0.001), anxiety score ( p  < 0.001), hidden anxiety score ( p  = 0.003) and obvious anxiety score ( p  < 0.001) after intervention, with a statistically significant difference were lower than the control group.
","['primiparous mothers', 'two members of each family (husband and other family of the pregnant woman', '2016 on 72 family members of pregnant women who were referred to midwifery clinics in two health centers in Saveh-Iran', 'primiparous mothers during delivery']",[],"['hidden anxiety score', 'obvious anxiety score', 'anxiety score', 'Stress and Cattell Anxiety scale', 'stress and anxiety', 'Perceived stress score', 'mean scores of stress, anxiety, hidden anxiety and obvious anxiety']","[{'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0242664', 'cui_str': 'Husband (person)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",[],"[{'cui': 'C1719994', 'cui_str': 'Animal hide'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0157138,"In the intervention group, Perceived stress score ( p  < 0.001), anxiety score ( p  < 0.001), hidden anxiety score ( p  = 0.003) and obvious anxiety score ( p  < 0.001) after intervention, with a statistically significant difference were lower than the control group.
","[{'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Alaem', 'Affiliation': '1Student research committee, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Jalali', 'Affiliation': '2Psychiatric Nursing Department, School of Nursing and Midwifery, Substance Abuse Prevention Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Almasi', 'Affiliation': '3Research center of Environmental determinants of Health, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Abdi', 'Affiliation': '4Emergency and Critical Care Nursing Department, Nursing and Midwifery School, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Khalili', 'Affiliation': '5Midwifery Department, Nursing and Midwifery School, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",BioPsychoSocial medicine,['10.1186/s13030-019-0148-1']
540,31078475,Financial Incentives to Increase Cardiac Rehabilitation Participation Among Low-Socioeconomic Status Patients: A Randomized Clinical Trial.,"OBJECTIVES


This study sought to examine the efficacy of financial incentives to increase Medicaid patient participation in and completion of cardiac rehabilitation (CR).
BACKGROUND


Participation in CR reduces morbidity, mortality, and hospitalizations while improving quality of life. Lower-socioeconomic status (SES) patients are much less likely to attend and complete CR, despite being at increased risk for recurrent cardiovascular events.
METHODS


A total of 130 individuals enrolled in Medicaid with a CR-qualifying cardiac event were randomized 1:1 to receive financial incentives on an escalating schedule ($4 to $50) for completing CR sessions or to receive usual care. Primary outcomes were CR participation (number of sessions completed) and completion (≥30 sessions completed). Secondary outcomes included changes in sociocognitive measurements (depressive/anxious symptoms, executive function), body composition (waist circumference, body mass index), fitness (peak VO 2 ) over 4 months, and combined number of hospitalizations and emergency department (ED) contacts over 1 year.
RESULTS


Patients randomized to the incentive condition completed more sessions (22.4 vs. 14.7, respectively; p = 0.013) and were almost twice as likely to complete CR (55.4% vs. 29.2%, respectively; p = 0.002) as controls. Incentivized patients were also more likely to experience improvements in executive function (p < 0.001), although there were no significant effects on other secondary outcomes. Patients who completed ≥30 sessions had 47% fewer combined hospitalizations and ED visits (p = 0.014), as reflected by a nonsignificant trend by study condition with 39% fewer hospital contacts in the incentive condition group (p = 0.079).
CONCLUSIONS


Financial incentives improve CR participation among lower-SES patients following a cardiac event. Increasing participation among lower-SES patients in CR is critical for positive longer-term health outcomes. (Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees; NCT02172820).",2019,"Patients who completed ≥30 sessions had 47% fewer combined hospitalizations and ED visits (p = 0.014), as reflected by a nonsignificant trend by study condition with 39% fewer hospital contacts in the incentive condition group (p = 0.079).
","['A total of 130 individuals enrolled in Medicaid with a CR-qualifying cardiac event', 'Low-Socioeconomic Status Patients']",['financial incentives on an escalating schedule ($4 to $50) for completing CR sessions or to receive usual care'],"['hospital contacts', 'CR participation', 'morbidity, mortality, and hospitalizations while improving quality of life', 'CR participation (number of sessions completed) and completion', 'executive function', 'combined hospitalizations and ED visits', 'changes in sociocognitive measurements (depressive/anxious symptoms, executive function), body composition (waist circumference, body mass index), fitness (peak VO 2 ) over 4 months, and combined number of hospitalizations and emergency department (ED) contacts over 1 year']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",130.0,0.103883,"Patients who completed ≥30 sessions had 47% fewer combined hospitalizations and ED visits (p = 0.014), as reflected by a nonsignificant trend by study condition with 39% fewer hospital contacts in the incentive condition group (p = 0.079).
","[{'ForeName': 'Diann E', 'Initials': 'DE', 'LastName': 'Gaalema', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, Vermont; Department of Psychology, University of Vermont, Burlington, Vermont. Electronic address: dgaalema@uvm.edu.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Elliott', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'Savage', 'Affiliation': 'Division of Cardiology, University of Vermont Medical Center, Burlington, Vermont.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Rengo', 'Affiliation': 'Division of Cardiology, University of Vermont Medical Center, Burlington, Vermont.'}, {'ForeName': 'Alex Y', 'Initials': 'AY', 'LastName': 'Cutler', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Pericot-Valverde', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Priest', 'Affiliation': 'Department of Medical Biostatistics, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Donald S', 'Initials': 'DS', 'LastName': 'Shepard', 'Affiliation': 'Heller School for Social Policy and Management, Brandeis University, Waltham, Massachusetts.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Higgins', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, Vermont; Department of Psychology, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Ades', 'Affiliation': 'Division of Cardiology, University of Vermont Medical Center, Burlington, Vermont.'}]",JACC. Heart failure,['10.1016/j.jchf.2018.12.008']
541,31735996,Effect of eccentric-based rehabilitation on hand tremor intensity in Parkinson disease.,"BACKGROUND AND PURPOSE


Hand tremor is a disturbing yet sometimes resistant symptom in persons with Parkinson disease (PD). Although many exercise regimens for these people have gained attention in recent years, the effect of resistance training and especially eccentric training on parkinsonian tremor is still uncertain. This study was conducted to investigate the precise effect of upper limb eccentric training on hand tremor in PD.
METHODS


In this randomized controlled trial, a consecutive sample of 21 persons with PD recruited from general hospitals went through 6 weeks of upper limb pure eccentric training as the intervention group (n = 11) or no additional exercise during this period as the control group (n = 10). Resting and postural tremor amplitudes were measured with the cellphone-based accelerometer.
RESULTS


Comparing hand tremor amplitudes before and after the trial showed a significant reduction in resting tremor amplitude in the intervention group after exercise sessions (p < 0.05) while detecting no changes in the control group during 6 weeks of study. Meanwhile, postural tremor amplitude remained unchanged in both groups.",2020,"RESULTS


Comparing hand tremor amplitudes before and after the trial showed a significant reduction in resting tremor amplitude in the intervention group after exercise sessions (p < 0.05) while detecting no changes in the control group during 6 weeks of study.","['21 persons with PD recruited from general hospitals went through 6 weeks of', 'persons with Parkinson disease (PD', 'Parkinson disease']","['eccentric-based rehabilitation', 'eccentric training', 'upper limb pure eccentric training as the intervention group (n = 11) or no additional exercise', 'upper limb eccentric training']","['resting tremor amplitude', 'Resting and postural tremor amplitudes', 'Meanwhile, postural tremor amplitude']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0234379', 'cui_str': 'Resting Tremor'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234378', 'cui_str': 'Static Tremor'}]",21.0,0.0179724,"RESULTS


Comparing hand tremor amplitudes before and after the trial showed a significant reduction in resting tremor amplitude in the intervention group after exercise sessions (p < 0.05) while detecting no changes in the control group during 6 weeks of study.","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Kadkhodaie', 'Affiliation': 'Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences, Firoozgar Hospital, Behafarin St., Karim Khan St., Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sharifnezhad', 'Affiliation': 'Department of Sport Biomechanics and Technology, Sport Sciences Research Institute, No 3, Alley 5, Mir Emad St., Motahari St., Tehran, Iran. a.sharifnezhad@ssrc.ac.ir.'}, {'ForeName': 'Safoora', 'Initials': 'S', 'LastName': 'Ebadi', 'Affiliation': 'Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences, Firoozgar Hospital, Behafarin St., Karim Khan St., Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Marzban', 'Affiliation': 'Department of Biomedical Engineering, Amirkabir University of Technology, Tehran, Iran.'}, {'ForeName': 'Seyed Amirhassan', 'Initials': 'SA', 'LastName': 'Habibi', 'Affiliation': 'Department of Neurology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Ghaffari', 'Affiliation': 'School of Rehabilitation Science, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Forogh', 'Affiliation': 'Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences, Firoozgar Hospital, Behafarin St., Karim Khan St., Tehran, Iran. bijanfr@gmail.com.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-019-04106-9']
542,30978122,Effectiveness of a manualised group training intervention for memory dysfunction following stroke: a series of single case studies.,"Purpose:  Deficits in memory are common following stroke and have been independently linked with poorer outcomes. Outcomes and best-practice processes of post-stroke memory rehabilitation remain equivocal. Materials and method:  In this study an AB with follow up single-case design was repeated across four participants to explore the effectiveness of a compensatory memory skills group in patients with stroke. Target behaviour was subjective everyday and prospective memory failures, assessed weekly. Secondary outcomes included goal attainment and performance on neuropsychological tests of memory. Following three-week baseline, participants completed six weekly two-hour sessions of a manualised memory group. Data was analysed visually and statistically. Results and conclusion:  Frequency of everyday memory complaints reduced for all participants during the six-week post-intervention period. This change was significant for three participants. One of the four participants reported a significant reduction in the frequency of prospective memory failures during the maintenance period. All participants described attaining at least one memory specific goal following intervention. Group participation did not result in meaningful change on neuropsychological measures of memory. Taken together, results provided preliminary support for the effectiveness of group-based compensatory memory rehabilitation for reducing subjective everyday memory failures and functional goal attainment.IMPLICATIONS FOR REHABILITATIONMemory skills group training can improve subjective everyday memory and functional goal attainment in community dwelling survivors of stroke.Participants who are closer to date of injury may show greater changes in self-awareness as a consequence of group participation than those who are further from injury.Exploration of change following memory rehabilitation on standard neuropsychological tests may not be the best way to capture improvement following memory skills group training. A focus on functional memory outcomes is recommended to facilitate translation to person-centred clinical practice.",2020,IMPLICATIONS FOR REHABILITATION Memory skills group training can improve subjective everyday memory and functional goal attainment in community dwelling survivors of stroke.,"['patients with stroke', 'community dwelling survivors of stroke', 'memory dysfunction following stroke']","['manualised group training intervention', 'memory rehabilitation']","['self-awareness', 'subjective everyday memory and functional goal attainment', 'goal attainment and performance on neuropsychological tests of memory', 'neuropsychological measures of memory', 'frequency of prospective memory failures', 'everyday memory complaints']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C3887551', 'cui_str': 'Memory dysfunction'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C3146223', 'cui_str': 'Awareness of self (observable entity)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0589154', 'cui_str': 'Memory, Prospective'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}]",,0.0622371,IMPLICATIONS FOR REHABILITATION Memory skills group training can improve subjective everyday memory and functional goal attainment in community dwelling survivors of stroke.,"[{'ForeName': 'Toni D', 'Initials': 'TD', 'LastName': 'Withiel', 'Affiliation': 'Monash Institute of Cognitive and Clinical Neurosciences, School of Psychological Sciences, Monash University, Clayton, Australia.'}, {'ForeName': 'Renerus J', 'Initials': 'RJ', 'LastName': 'Stolwyk', 'Affiliation': 'Monash Institute of Cognitive and Clinical Neurosciences, School of Psychological Sciences, Monash University, Clayton, Australia.'}, {'ForeName': 'Jennie L', 'Initials': 'JL', 'LastName': 'Ponsford', 'Affiliation': 'Monash Institute of Cognitive and Clinical Neurosciences, School of Psychological Sciences, Monash University, Clayton, Australia.'}, {'ForeName': 'Dominique A', 'Initials': 'DA', 'LastName': 'Cadilhac', 'Affiliation': 'Stroke and Ageing Research, School of Clinical Sciences, Monash University, Clayton, Australia.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Wong', 'Affiliation': 'Monash Institute of Cognitive and Clinical Neurosciences, School of Psychological Sciences, Monash University, Clayton, Australia.'}]",Disability and rehabilitation,['10.1080/09638288.2019.1579260']
543,31005993,Prediction of the effect of dapagliflozin on kidney and heart failure outcomes based on short-term changes in multiple risk markers.,"BACKGROUND


Besides improving glucose control, sodium-glucose co-transporter 2 inhibition with dapagliflozin reduces blood pressure, body weight and urinary albumin:creatinine ratio (UACR) in patients with type 2 diabetes (T2DM). The parameter response efficacy (PRE) score was developed to predict how short-term drug effects on cardiovascular risk markers translate into long-term changes in clinical outcomes. We applied the PRE score to clinical trials of dapagliflozin to model the effect of the drug on kidney and heart failure (HF) outcomes in patients with T2DM and impaired kidney function.
METHODS


The relationships between multiple risk markers and long-term outcome were determined in a background population of patients with T2DM with a multivariable Cox model. These relationships were then applied to short-term changes in risk markers observed in a pooled database of dapagliflozin trials (n = 7) that recruited patients with albuminuria to predict the drug-induced changes to kidney and HF outcomes.
RESULTS


A total of 132 and 350 patients had UACR >200 mg/g and >30 mg/g at baseline, respectively, and were selected for analysis. The PRE score predicted a risk change for kidney events of -40.8% [95% confidence interval (CI) -51.7 to -29.4) and -40.4% (95% CI -48.4 to -31.1) with dapagliflozin 10 mg compared with placebo for the UACR >200 mg/g and >30 mg/g subgroups. The predicted change in risk for HF events was -27.3% (95% CI -47.7 to -5.1) and -21.2% (95% CI -35.0 to -7.8), respectively. Simulation analyses showed that even with a smaller albuminuria-lowering effect of dapagliflozin (10% instead of the observed 35% in both groups), the estimated kidney risk reduction was still 26.5 and 26.8%, respectively.
CONCLUSIONS


The PRE score predicted clinically meaningful reductions in kidney and HF events associated with dapagliflozin therapy in patients with diabetic kidney disease. These results support a large long-term outcome trial in this population to confirm the benefits of the drug on these endpoints.",2020,The PRE score predicted a risk change for kidney events of -40.8% [95% confidence interval (CI) -51.7 to -29.4) and -40.4% (95% CI -48.4 to -31.1) with dapagliflozin 10 mg compared with placebo for the UACR >200 mg/g and >30 ,"['patients with type 2 diabetes (T2DM', 'A total of 132 and 350 patients had UACR\u2009>200\u2009mg/g and >30\u2009mg/g at baseline, respectively, and were selected for analysis', 'patients with T2DM and impaired kidney function', 'patients with diabetic kidney disease']","['dapagliflozin therapy', 'placebo', 'dapagliflozin']","['parameter response efficacy (PRE) score', 'multiple risk markers', 'blood pressure, body weight and urinary albumin:creatinine ratio (UACR', 'risk for HF events', 'kidney risk reduction', 'kidney and heart failure (HF) outcomes', 'PRE score predicted a risk change for kidney events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0689993,The PRE score predicted a risk change for kidney events of -40.8% [95% confidence interval (CI) -51.7 to -29.4) and -40.4% (95% CI -48.4 to -31.1) with dapagliflozin 10 mg compared with placebo for the UACR >200 mg/g and >30 ,"[{'ForeName': 'Nienke M A', 'Initials': 'NMA', 'LastName': 'Idzerda', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Bergur V', 'Initials': 'BV', 'LastName': 'Stefansson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Pena', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Sjostrom', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'Department of Renal Medicine, University College London, London, UK.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz064']
544,31056441,"CFTR activity is enhanced by the novel corrector GLPG2222, given with and without ivacaftor in two randomized trials.","BACKGROUND


Several treatment approaches in cystic fibrosis (CF) aim to correct CF transmembrane conductance regulator (CFTR) function; the efficacy of each approach is dependent on the mutation(s) present. A need remains for more effective treatments to correct functional deficits caused by the F508del mutation.
METHODS


Two placebo-controlled, phase 2a studies evaluated GLPG2222, given orally once daily for 29 days, in subjects homozygous for F508del (FLAMINGO) or heterozygous for F508del and a gating mutation, receiving ivacaftor (ALBATROSS). The primary objective of both studies was to assess safety and tolerability. Secondary objectives included assessment of pharmacokinetics, and of the effect of GLPG2222 on sweat chloride concentrations, pulmonary function and respiratory symptoms.
RESULTS


Fifty-nine and 37 subjects were enrolled into FLAMINGO and ALBATROSS, respectively. Treatment-related treatment-emergent adverse events (TEAEs) were reported by 29.2% (14/48) of subjects in FLAMINGO and 40.0% (12/30) in ALBATROSS; most were mild to moderate in severity and comprised primarily respiratory, gastrointestinal, and infection events. There were no deaths or discontinuations due to TEAEs. Dose-dependent decreases in sweat chloride concentrations were seen in GLPG2222-treated subjects (maximum decrease in FLAMINGO: -17.6 mmol/L [GLPG2222 200 mg], p < 0.0001; ALBATROSS: -7.4 mmol/L [GLPG2222 300 mg], p < 0.05). No significant effects on pulmonary function or respiratory symptoms were reported. Plasma GLPG2222 concentrations in CF subjects were consistent with previous studies in healthy volunteers and CF subjects.
CONCLUSIONS


GLPG2222 was well tolerated. Sweat chloride reductions support on-target enhancement of CFTR activity in subjects with F508del mutation(s). Significant improvements in clinical endpoints were not demonstrated. Observed safety results support further evaluation of GLPG2222, including in combination with other CFTR modulators.
FUNDING


Galapagos NV. Clinical trial registration numbers FLAMINGO, NCT03119649; ALBATROSS, NCT03045523.",2019,"Treatment-related treatment-emergent adverse events (TEAEs) were reported by 29.2% (14/48) of subjects in FLAMINGO and 40.0% (12/30) in ALBATROSS; most were mild to moderate in severity and comprised primarily respiratory, gastrointestinal, and infection events.","['subjects homozygous for F508del (FLAMINGO) or heterozygous for F508del and a gating mutation, receiving ivacaftor (ALBATROSS', 'healthy volunteers and CF subjects', 'Fifty-nine and 37 subjects', 'subjects with F508del mutation(s', 'CF subjects', 'cystic fibrosis (CF']",['GLPG2222'],"['sweat chloride concentrations', 'safety and tolerability', 'tolerated', 'CFTR activity', 'Plasma GLPG2222 concentrations', 'sweat chloride concentrations, pulmonary function and respiratory symptoms', 'pulmonary function or respiratory symptoms']","[{'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C1006611', 'cui_str': 'Albatrosses'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]",[],"[{'cui': 'C0428295', 'cui_str': 'Cystic fibrosis sweat test (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}]",,0.067018,"Treatment-related treatment-emergent adverse events (TEAEs) were reported by 29.2% (14/48) of subjects in FLAMINGO and 40.0% (12/30) in ALBATROSS; most were mild to moderate in severity and comprised primarily respiratory, gastrointestinal, and infection events.","[{'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Bell', 'Affiliation': 'Department of Thoracic Medicine, The Prince Charles Hospital and QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia. Electronic address: scott.bell@health.qld.gov.au.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Barry', 'Affiliation': 'Manchester Adult Cystic Fibrosis Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'De Boeck', 'Affiliation': 'University Hospital Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Drevinek', 'Affiliation': 'Department of Medical Microbiology, Charles University, Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'J Stuart', 'Initials': 'JS', 'LastName': 'Elborn', 'Affiliation': ""Queen's University, Belfast, UK.""}, {'ForeName': 'Barry J', 'Initials': 'BJ', 'LastName': 'Plant', 'Affiliation': 'University College Cork, Cork, Ireland.'}, {'ForeName': 'Predag', 'Initials': 'P', 'LastName': 'Minić', 'Affiliation': 'Mother and Child Health Institute of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Van Braeckel', 'Affiliation': 'Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Verhulst', 'Affiliation': 'Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Muller', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Desirée', 'Initials': 'D', 'LastName': 'Kanters', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bellaire', 'Affiliation': 'Galapagos UBV, Leiden, the Netherlands.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'de Kock', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Geller', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Conrath', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Van de Steen', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Kors', 'Initials': 'K', 'LastName': 'van der Ent', 'Affiliation': 'UMC Utrecht, Utrecht, the Netherlands.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2019.04.014']
545,31042551,Bucindolol for the Maintenance of Sinus Rhythm in a Genotype-Defined HF Population: The GENETIC-AF Trial.,"OBJECTIVES


The purpose of this study was to compare the effectiveness of bucindolol with that of metoprolol succinate for the maintenance of sinus rhythm in a genetically defined heart failure (HF) population with atrial fibrillation (AF).
BACKGROUND


Bucindolol is a beta-blocker whose unique pharmacologic properties provide greater benefit in HF patients with reduced ejection fraction (HFrEF) who have the beta 1 -adrenergic receptor (ADRB1) Arg389Arg genotype.
METHODS


A total of 267 HFrEF patients with a left ventricular ejection fraction (LVEF) <0.50, symptomatic AF, and the ADRB1 Arg389Arg genotype were randomized 1:1 to receive bucindolol or metoprolol therapy and were up-titrated to target doses. The primary endpoint of AF or atrial flutter (AFL) or all-cause mortality (ACM) was evaluated by electrocardiogram (ECG) during a 24-week period.
RESULTS


The hazard ratio (HR) for the primary endpoint was 1.01 (95% confidence interval [CI]: 0.71 to 1.42), but trends for bucindolol benefit were observed in several subgroups. Precision therapeutic phenotyping revealed that a differential response to bucindolol was associated with the interval of time from the initial diagnoses of AF and HF to randomization and with the onset of AF relative to that of the initial HF diagnosis. In a cohort whose first AF and HF diagnoses were <12 years prior to randomization, in which AF onset did not precede HF by more than 2 years (n = 196), the HR was 0.54 (95% CI: 0.33 to 0.87; p = 0.011).
CONCLUSIONS


Pharmacogenetically guided bucindolol therapy did not reduce the recurrence of AF/AFL or ACM compared to that of metoprolol therapy in HFrEF patients, but populations were identified who merited further investigation in future phase 3 trials.",2019,"CONCLUSIONS


Pharmacogenetically guided bucindolol therapy did not reduce the recurrence of AF/AFL or ACM compared to that of metoprolol therapy in HFrEF patients, but populations were identified who merited further investigation in future phase 3 trials.","['sinus rhythm in a genetically defined heart failure (HF) population with atrial fibrillation (AF', 'HF patients with reduced ejection fraction (HFrEF) who have the beta 1 -adrenergic receptor (ADRB1', '267 HFrEF patients with a left ventricular ejection fraction (LVEF)\xa0<0.50, symptomatic AF, and the ADRB1']","['bucindolol', 'metoprolol succinate', 'Bucindolol', 'metoprolol', 'bucindolol or metoprolol therapy']","['bucindolol benefit', 'recurrence of AF/AFL or ACM', 'hazard ratio (HR', 'AF or atrial flutter (AFL) or all-cause mortality (ACM']","[{'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0001642', 'cui_str': 'Receptors, Adrenergic, beta-1'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C0054196', 'cui_str': 'bucindolol'}, {'cui': 'C0724633', 'cui_str': 'metoprolol succinate'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0054196', 'cui_str': 'bucindolol'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0004239', 'cui_str': 'Auricular Flutter'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",267.0,0.0335906,"CONCLUSIONS


Pharmacogenetically guided bucindolol therapy did not reduce the recurrence of AF/AFL or ACM compared to that of metoprolol therapy in HFrEF patients, but populations were identified who merited further investigation in future phase 3 trials.","[{'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Piccini', 'Affiliation': 'Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina. Electronic address: jonathan.piccini@duke.edu.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Abraham', 'Affiliation': 'Ohio State University Medical Center, Columbus, Ohio.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Dufton', 'Affiliation': 'ARCA Biopharma, Inc., Westminster, Colorado.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Carroll', 'Affiliation': 'ARCA Biopharma, Inc., Westminster, Colorado.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Sauer', 'Affiliation': 'University of Colorado, Boulder, Colorado.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'U.S. Department of Veterans Affairs, Washington, DC.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'White', 'Affiliation': 'Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Wilton', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Aleong', 'Affiliation': 'University of Colorado, Boulder, Colorado.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Rienstra', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Krueger', 'Affiliation': 'Bryan Heart Institute, Columbus, Nebraska.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Ayala-Paredes', 'Affiliation': 'Centre Hospitalier Universitaire de Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Yaariv', 'Initials': 'Y', 'LastName': 'Khaykin', 'Affiliation': 'Southlake Regional Health Centre, Newmarket, Ontario, Canada.'}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center of the Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Miloradović', 'Affiliation': 'University of Kragujevac and Clinical Center Kragujevac, Kragujevac, Serbia.'}, {'ForeName': 'Jerzy K', 'Initials': 'JK', 'LastName': 'Wranicz', 'Affiliation': 'Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Ilkhanoff', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Ziegler', 'Affiliation': 'Medtronic, Mounds View, Minnesota.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': 'ARCA Biopharma, Inc., Westminster, Colorado.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Emery', 'Affiliation': 'ARCA Biopharma, Inc., Westminster, Colorado.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Marshall', 'Affiliation': 'ARCA Biopharma, Inc., Westminster, Colorado.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Kao', 'Affiliation': 'University of Colorado, Boulder, Colorado.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Bristow', 'Affiliation': 'ARCA Biopharma, Inc., Westminster, Colorado; University of Colorado, Boulder, Colorado.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2019.04.004']
546,31025258,On-demand versus continuous rocuronium infusion for deep neuromuscular relaxation in patients undergoing thoraco-laparoscopic esophagectomy: a randomized-controlled clinical trial (DEPTH).,"PURPOSE


Deep neuromuscular blockade (NMB) can improve surgical conditions and possibly pain after low-risk laparoscopic surgery. We hypothesized that targeting a deep level of NMB by a continuous compared with an on-demand infusion of rocuronium could improve surgical conditions in patients undergoing thoraco-laparoscopic esophagectomy.
METHODS


In this single-centre, randomized-controlled, double-blind trial, patients received either a continuous infusion of rocuronium 0.6 mg·kg -1 ·hr -1  (intervention) or NaCl 0.9% (control). Both surgeon and anesthesiologist were blinded to group assignment and the train-of-four measurements. Open-label rocuronium was given if requested (i.e., on-demand) by the surgeon. At the end of surgery, sugammadex was given if necessary to reverse the NMB. The primary outcome was the quality of surgical conditions during the abdominal phase of the operation as measured by the surgical rating scale (SRS). Secondary outcomes included the thoracic SRS, number of on-demand boluses, intraoperative surgical events, pain scores (up to 12 hr postoperatively), and duration of surgery.
RESULTS


The median [interquartile range] abdominal SRS was not different between the intervention (4 [4-5]) and control (4 [4-5]) groups (median difference, 0; 95% confidence interval, 0 to 0; P = 0.45). The thoracic SRS was 4 [4-4] in both groups (P = 0.23). The median number of rocuronium bolus requests was higher in the control group compared with the intervention group (3 [3-6] vs 1 [0-2], respectively; P < 0.01). There were no between-group differences in intraoperative surgical events (P = 0.05), pain scores (overall P > 0.05), or duration of surgery (P = 0.95).
CONCLUSIONS


Continuous rocuronium infusion did not improve surgical conditions when boluses of rocuronium were available on-demand. No major benefits in other outcomes were seen.
TRIAL REGISTRATION


EUDRACT (2014-002147-18); registered 19 May, 2014 and clinicaltrials.gov (NCT02320734); registered 18 December, 2014.",2019,"There were no between-group differences in intraoperative surgical events (P = 0.05), pain scores (overall P > 0.05), or duration of surgery (P = 0.95).
",['patients undergoing thoraco-laparoscopic esophagectomy'],"['Open-label rocuronium', 'rocuronium infusion', 'rocuronium', 'Deep neuromuscular blockade (NMB', 'rocuronium 0.6 mg·kg -1 ·hr -1  (intervention) or NaCl 0.9% (control']","['surgical conditions', 'thoracic SRS', 'pain scores', 'thoracic SRS, number of on-demand boluses, intraoperative surgical events, pain scores (up to 12 hr postoperatively), and duration of surgery', 'duration of surgery', 'quality of surgical conditions during the abdominal phase of the operation as measured by the surgical rating scale (SRS', 'median [interquartile range] abdominal SRS', 'intraoperative surgical events', 'median number of rocuronium bolus requests']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1444752', 'cui_str': 'Status during (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]",,0.692189,"There were no between-group differences in intraoperative surgical events (P = 0.05), pain scores (overall P > 0.05), or duration of surgery (P = 0.95).
","[{'ForeName': 'Denise P', 'Initials': 'DP', 'LastName': 'Veelo', 'Affiliation': 'Department of Anesthesiology, Academic Medical Center, Meibergdreef 9, H1-158, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Suzanne S', 'Initials': 'SS', 'LastName': 'Gisbertz', 'Affiliation': 'Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Binnekade', 'Affiliation': 'Department of Intensive Care Medicine, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Rebekka A', 'Initials': 'RA', 'LastName': 'Hannivoort', 'Affiliation': 'Department of Anesthesiology, Academic Medical Center, Meibergdreef 9, H1-158, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Johanneke A', 'Initials': 'JA', 'LastName': 'Bosman', 'Affiliation': 'Department of Anesthesiology, Academic Medical Center, Meibergdreef 9, H1-158, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Bart F', 'Initials': 'BF', 'LastName': 'Geerts', 'Affiliation': 'Department of Anesthesiology, Academic Medical Center, Meibergdreef 9, H1-158, 1105 AZ, Amsterdam, The Netherlands. B.F.Geerts@amc.uva.nl.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Blobner', 'Affiliation': 'Klinik für Anästhesiologie der Technischen Universität München, Munich, Germany.'}, {'ForeName': 'Mark I', 'Initials': 'MI', 'LastName': 'van Berge Henegouwen', 'Affiliation': 'Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Department of Anesthesiology, Academic Medical Center, Meibergdreef 9, H1-158, 1105 AZ, Amsterdam, The Netherlands.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01373-0']
547,31074184,Acetazolamide to increase natriuresis in congestive heart failure at high risk for diuretic resistance.,"AIMS


To investigate the effects of acetazolamide on natriuresis, decongestion, kidney function and neurohumoral activation in acute heart failure (AHF).
METHODS AND RESULTS


This prospective, two-centre study included 34 AHF patients on loop diuretics with volume overload. All had a serum sodium concentration < 135 mmol/L and/or serum urea/creatinine ratio > 50 and/or an admission serum creatinine increase of > 0.3 mg/dL compared to baseline. Patients were randomised towards acetazolamide 250-500 mg daily plus bumetanide 1-2 mg bid vs. high-dose loop diuretics (bumetanide bid with daily dose twice the oral maintenance dose). The primary endpoint was natriuresis after 24 h. Natriuresis after 24 h was similar in the combinational treatment vs. loop diuretic only arm (264 ± 126 vs. 234 ± 133 mmol; P = 0.515). Loop diuretic efficiency, defined as natriuresis corrected for loop diuretic dose, was higher in the group receiving acetazolamide (84 ± 46 vs. 52 ± 42 mmol/mg bumetanide; P = 0.048). More patients in the combinational treatment arm had an increase in serum creatinine levels > 0.3 mg/dL (P = 0.046). N-terminal pro-B-type natriuretic peptide reduction and peak neurohumoral activation within 72 h were comparable among treatment arms. There was a non-significant trend towards lower all-cause mortality or heart failure readmissions in the group receiving acetazolamide with low-dose loop diuretics vs. high-dose loop diuretic monotherapy (P = 0.098).
CONCLUSION


Addition of acetazolamide increases the natriuretic response to loop diuretics compared to an increase in loop diuretic dose in AHF at high risk for diuretic resistance.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01973335.",2019,"There was a non-significant trend towards lower all-cause mortality or heart failure readmissions in the group receiving acetazolamide with low-dose loop diuretics vs. high-dose loop diuretic monotherapy (P = 0.098).
","['acute heart failure (AHF', 'congestive heart failure at high risk for diuretic resistance', '34 AHF patients on loop diuretics with volume overload']","['bumetanide', 'acetazolamide 250-500\u2009mg daily plus bumetanide', 'Acetazolamide', 'acetazolamide', 'loop diuretics (bumetanide']","['natriuresis, decongestion, kidney function and neurohumoral activation', 'natriuretic response', 'serum sodium concentration', 'cause mortality or heart failure readmissions', 'natriuresis after 24\u2009h. Natriuresis', 'serum creatinine levels ']","[{'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0354100', 'cui_str': 'Loop Diuretics'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia (disorder)'}]","[{'cui': 'C0006376', 'cui_str': 'Bumetanide'}, {'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}]","[{'cui': 'C0027477', 'cui_str': 'Natriuresis'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}]",34.0,0.257808,"There was a non-significant trend towards lower all-cause mortality or heart failure readmissions in the group receiving acetazolamide with low-dose loop diuretics vs. high-dose loop diuretic monotherapy (P = 0.098).
","[{'ForeName': 'Frederik H', 'Initials': 'FH', 'LastName': 'Verbrugge', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Martens', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Ameloot', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Haemels', 'Affiliation': 'Department of Cardiovascular Medicine, UZ Leuven, Leuven, Belgium.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Penders', 'Affiliation': 'Department of Laboratory Medicine, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Dupont', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Wai Hong Wilson', 'Initials': 'WHW', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Droogné', 'Affiliation': 'Department of Cardiovascular Medicine, UZ Leuven, Leuven, Belgium.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Mullens', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}]",European journal of heart failure,['10.1002/ejhf.1478']
548,32410684,A sex education program for teachers of preschool children: a quasi-experimental study in Iran.,"BACKGROUND


Sex education is an important educational dimension. Together with families, teachers play a significant role in providing sex education to children. However, in most cases, they do not have enough information on this topic. The present study aimed to determine the effects of a preschool sex education program on preschool teachers' knowledge and attitude.
METHODS


In this quasi-experimental study, 80 teachers working at preschools in Tehran, Iran, were randomly allocated to experimental and control groups. The educational program was provided in two 90-min sessions for the experimental group while the control group received no intervention. A self-designed knowledge and attitude questionnaire was completed by both groups before and 1 month after the intervention. This questionnaire evaluated knowledge and attitude in six domains of principles of sex education, sexual identity, stages of development and proper methods of sex education, sex-related questions, masturbation, and sexual abuse. Data were analysed in SPSS 18 using descriptive statistics as well as independent samples t-test, paired-samples t-test, chi-squared test, and ANCOVA at p < 0.05.
RESULTS


Mean scores of knowledge and attitude in all dimensions showed a significant increase in the experimental group following the educational intervention. However, no difference was observed in the control group. Following the educational intervention, mean scores of teachers' knowledge and attitude in all six domains showed a significant difference with that of the control group (p < 0.001).
CONCLUSIONS


Results revealed that the sex education program can promote the knowledge and attitude of preschool teachers in all domains.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials: IRCT2016122320854N5. Registered on 9 March 2017. ""Retrospectively registered"".",2020,"Following the educational intervention, mean scores of teachers' knowledge and attitude in all six domains showed a significant difference with that of the control group (p < 0.001).
","['80 teachers working at preschools in Tehran, Iran', 'teachers of preschool children']","['preschool sex education program', 'control group received no intervention']","[""preschool teachers' knowledge and attitude"", 'Mean scores of knowledge and attitude', ""mean scores of teachers' knowledge and attitude""]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}]","[{'cui': 'C0036879', 'cui_str': 'Sexuality education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",80.0,0.0143106,"Following the educational intervention, mean scores of teachers' knowledge and attitude in all six domains showed a significant difference with that of the control group (p < 0.001).
","[{'ForeName': 'Jeno', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Department of Midwifery and Reproductive Health, Student Research Committee, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hedyeh', 'Initials': 'H', 'LastName': 'Riazi', 'Affiliation': 'Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, ValiAsr Ave., Cross of Niayesh Highway and ValiAsr, Tehran, 1996835119, Iran. h.riazi@sbmu.ac.ir.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Firoozi', 'Affiliation': 'Department of Psychology, School of Psychology and Social Sciences, Islamic Azad University Roudehen branch, Tehran, Iran.'}, {'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'Department of Biostatics, School of Paramedical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",BMC public health,['10.1186/s12889-020-08826-y']
549,30990245,Two-year safety evaluation of a biodegradable polymer sirolimus-eluting stent with increased drug elution and polymer absorption kinetics in complex patient and lesion cohort.,"OBJECTIVES


The aim of the present report was to compare 2-year safety outcomes of two biodegradable polymer (BP) sirolimus-eluting stents (SESs) with different drug eluting and polymer absorption kinetics in a subgroup of complex patients and lesions.
BACKGROUND


The previously published PANDA III study showed the BuMA BP SES, with faster drug elution and polymer absorption, was non-inferior to the Excel SES in target lesion failure (TLF).
METHODS


In PANDA III trial, patients who fulfilled one or more of the following criteria were included: Small vessel disease (reference vessel diameter ≤ 2.5 mm); long lesion (lesion length ≥ 20 mm); chronic total occlusion lesion; and diabetic patients.
RESULTS


Among 2,348 patients randomly assigned to treatment with BuMA (n = 1,174) or Excel SES (n = 1,174) in the PANDA III study, 858 in the BuMA group and 855 in the Excel group satisfied the inclusion criteria. At 2-year follow-up, the incidence of definite/probable stent thrombosis (ST) was significantly lower with BuMA SES as compared with Excel SES (0.7% vs. 1.9%, p = 0.03). This difference was mainly caused by decreased subacute stent thrombosis rate (0% vs. 0.6%, p = 0.03). In patients who did not fulfill the complex patient and lesion criteria, there were no between-group difference in ST (0.7% vs. 0%, p = 0.50). Myocardial infarction and TLF rates were similar (5.7% vs. 6.0%, p = 0.79 and 8.8% vs. 7.5%, p = 0.34, respectively), whereas patient-oriented composite endpoint was higher with BuMA SES mainly due to high risk of revascularization (15.6% vs. 11.4%, p = 0.01; 8.4% vs. 4.6%, p < 0.01).
CONCLUSIONS


Two-year subgroup analysis of the all-comer PANDA III trial revealed the increased safety benefit of the BuMA SES is more prominently seen in complex patient and lesion population.
CLINICAL TRIAL


ClinicalTrial.gov, Identifier-NCT02017275.",2020,"Myocardial infarction and TLF rates were similar (5.7% vs. 6.0%, p = 0.79 and 8.8% vs. 7.5%, p = 0.34, respectively), whereas patient-oriented composite endpoint was higher with BuMA SES mainly due to high risk of revascularization (15.6% vs. 11.4%, p = 0.01; 8.4% vs. 4.6%, p < 0.01).
","['2,348 patients randomly assigned to treatment with', 'patients who fulfilled one or more of the following criteria were included: Small vessel disease (reference vessel diameter\u2009≤\u20092.5 mm); long lesion (lesion length\u2009≥\u200920\u2009mm); chronic total occlusion lesion; and diabetic patients', 'a subgroup of complex patients and lesions', 'complex patient and lesion cohort']","['biodegradable polymer (BP) sirolimus-eluting stents (SESs', 'BuMA', 'biodegradable polymer sirolimus-eluting stent', 'Excel SES']","['2-year safety outcomes', 'drug elution and polymer absorption kinetics', 'subacute stent thrombosis rate', 'ST', 'Myocardial infarction and TLF rates', 'incidence of definite/probable stent thrombosis (ST']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0225988', 'cui_str': 'Structure of small blood vessel (organ)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]","[{'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C2740529', 'cui_str': 'Excel'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}]",2348.0,0.144185,"Myocardial infarction and TLF rates were similar (5.7% vs. 6.0%, p = 0.79 and 8.8% vs. 7.5%, p = 0.34, respectively), whereas patient-oriented composite endpoint was higher with BuMA SES mainly due to high risk of revascularization (15.6% vs. 11.4%, p = 0.01; 8.4% vs. 4.6%, p < 0.01).
","[{'ForeName': 'Sida', 'Initials': 'S', 'LastName': 'Jia', 'Affiliation': 'Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Changdong', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': 'Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jinqing', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Xuebin', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiology, Chinese PLA 252 Hospital, Baoding, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': 'Department of Cardiology, Kaifeng Central Hospital, Kaifeng, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Yunnan St. John's Hospital, Kunming, China.""}, {'ForeName': 'Zhanquan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Liaoning Provincial People's Hospital, Shenyang, China.""}, {'ForeName': 'Shaoping', 'Initials': 'S', 'LastName': 'Nie', 'Affiliation': 'Department of Cardiology, Affiliated Anzhen Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Hou', 'Affiliation': 'Department of Statistical Analysis, China Cardiovascular Research Foundation Inc, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Statistical Analysis, China Cardiovascular Research Foundation Inc, Beijing, China.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Brouwer', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Suryapranata', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Runlin', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28288']
550,30955351,Does exposure to information about dementia change stigma? An experimental study.,"Objectives:  Educational programs on dementia may backfire, as recipients could feel more negatively about people with dementia after exposure to the alarming symptoms (e.g., behavioral and psychological symptoms of dementia, or BPSD). This study aimed to investigate whether such exposures had any effect on stigma. Methods:  200 adults aged 18-83 years were randomly assigned to three groups. The first group read vignettes describing fictitious older adults with  memory impairment . The second group read the same vignettes that were expanded to include descriptions of  BPSD  (i.e., memory impairment cum BPSD). After reading the vignettes, both groups answered questions about stigma, while the third group directly responded to this questionnaire without reading any vignette (i.e., not exposed to experimental manipulation). ANOVA was performed to analyze the effect of experimental manipulation, as well as that of age, education, whether having relatives with dementia, and belief about treatability of dementia. Results:  At posttest, the level of stigma was moderate and was comparable across the three groups, suggesting that exposures to information about cognitive and behavioral symptoms did not change people's stigmatizing attitude. The absence of group effect in stigma did not vary by age, education, whether having a relative with dementia, or belief about prognosis. Only the main effects of age and education were significant, where younger and least educated participants reported higher stigma. Conclusion:  There was no evidence that stigma would be affected by exposure to information about symptoms of dementia, including the more disturbed ones (i.e., BPSD).",2020,"There was no evidence that stigma would be affected by exposure to information about symptoms of dementia, including the more disturbed ones (i.e., BPSD).","['fictitious older adults with memory impairment', '200 adults aged 18-83\u2009years']",[],"['higher stigma', 'level of stigma']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0233794', 'cui_str': 'Memory Deficits'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",200.0,0.0514736,"There was no evidence that stigma would be affected by exposure to information about symptoms of dementia, including the more disturbed ones (i.e., BPSD).","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong, Tai Po, Hong Kong.'}, {'ForeName': 'Sheung-Tak', 'Initials': 'ST', 'LastName': 'Cheng', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong, Tai Po, Hong Kong.'}]",Aging & mental health,['10.1080/13607863.2019.1599817']
551,30907143,Mapping the Functional Independence Measure to a multi-attribute utility instrument for economic evaluations in rehabilitation: a secondary analysis of randomized controlled trial data.,"Purpose:  To test whether the Functional Independence Measure (FIM) could be mapped to the EQ-5D-3L to give researchers a viable but ""second-best"" option for calculating quality-adjusted life-years (QALYs) and conducting a cost-utility analysis when only clinical outcomes have been collected. Materials and methods:  Secondary analysis of repeated measures data collected during a randomized controlled trial ( n  = 3506 observations) at two inpatient rehabilitation centres. Participants had a mean age of 74 (SD 13) years, 63% were women and 58% were admitted with an orthopaedic diagnosis. Ordinary least-squares regression and adjusted limited dependent variable mixture models were used to estimate regression-based mappings. Performance was evaluated based on mean absolute error and the proportion of errors in excess of the minimally important difference. Results:  In orthopaedic and neurological patients, high mean absolute errors (0.2 on the quality-adjusted life years scale) and a high proportion of errors (60%) in excess of the minimally important difference suggest that predicted EQ-5D-3L values provided a poor substitute for observed EQ-5D-3L values. Conclusions:  Regression-based mappings from the FIM to the EQ-5D-3L are error-prone and unsuitable for calculating QALYs in rehabilitation patients. Researchers and rehabilitation professionals should therefore include a multi-attribute utility instrument such as the EQ-5D as well as the FIM to evaluate the effect of rehabilitation interventions and in rehabilitation registries. This will provide additional information on health-related quality of life and support cost-utility analyses.Implications for rehabilitationThe Functional Independence Measure (FIM) cannot be used to calculate quality-adjusted life-years (QALYs) for cost-utility analyses.Predicting QALYs from FIM data is a poor substitute for direct measurement of QALYs in orthopaedic or neurological rehabilitation populations.Multi-attribute utility instruments (MAUIs) allow direct measurement of QALYs, as well as providing a patient-reported measure of clinical quality and outcomes in rehabilitation.A MAUI should be included routinely in clinical practice by rehabilitation professionals as well as in rehabilitation trials and registries to track patient outcomes and improve clinical practice.",2020,"In orthopaedic and neurological patients, high mean absolute errors (0.2 on the quality-adjusted life years scale) and a high proportion of errors (60%) in excess of the minimally important difference suggest that predicted EQ-5D-3L values provided a poor substitute for observed EQ-5D-3L values.
","['Secondary analysis of repeated measures data collected during a randomized controlled trial (n\u2009=\u20093506 observations) at two inpatient rehabilitation centres', 'Participants had a mean age of 74 (SD 13) years, 63% were women and 58% were admitted with an orthopaedic diagnosis']",[],[],"[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",[],[],,0.0445893,"In orthopaedic and neurological patients, high mean absolute errors (0.2 on the quality-adjusted life years scale) and a high proportion of errors (60%) in excess of the minimally important difference suggest that predicted EQ-5D-3L values provided a poor substitute for observed EQ-5D-3L values.
","[{'ForeName': 'Casey L', 'Initials': 'CL', 'LastName': 'Peiris', 'Affiliation': 'Department of Rehabilitation, Nutrition and Sport, Allied Health, Physiotherapy, College of Science, Health and Engineering, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'Taylor', 'Affiliation': 'Department of Rehabilitation, Nutrition and Sport, Allied Health, Physiotherapy, College of Science, Health and Engineering, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Watts', 'Affiliation': 'Faculty of Health, School of Health and Social Development, Deakin University, Burwood, Australia.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Shields', 'Affiliation': 'Department of Rehabilitation, Nutrition and Sport, Allied Health, Physiotherapy, College of Science, Health and Engineering, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Natasha K', 'Initials': 'NK', 'LastName': 'Brusco', 'Affiliation': 'Department of Rehabilitation, Nutrition and Sport, Allied Health, Physiotherapy, College of Science, Health and Engineering, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Mortimer', 'Affiliation': 'Centre for Health Economics, Monash Business School, Monash University, Clayton, Australia.'}]",Disability and rehabilitation,['10.1080/09638288.2019.1582720']
552,32407148,DIABEO System Combining a Mobile App Software With and Without Telemonitoring Versus Standard Care: A Randomized Controlled Trial in Diabetic Patients Poorly Controlled with a Basal-Bolus Insulin Regimen.,"Background:  The DIABEO ®  system (DS) is a telemedicine solution that combines a mobile app for patients with a web portal for health care providers. DS allows real-time monitoring of basal-bolus insulin therapy as well as therapeutic decision-making, integrating both basal and bolus dose calculation. Real-life studies have shown a very low rate of use of mobile health applications by patients. Therefore, we conducted a large randomized controlled trial study to investigate the efficacy of DS in conditions close to real life (TELESAGE study).  Methods:  TELESAGE was a multicenter, randomized, open study with three parallel arms: arm 1 (standard care), arm 2 (DIABEO alone), and arm 3 (DIABEO+telemonitoring by trained nurses). The primary outcome assessed the reduction in HbA 1c  levels after a 12-month follow-up.  Results:  Six hundred sixty-five patients were included in the study. Participants who used DIABEO once or more times a day (DIABEO users) showed a significant and meaningful reduction of HbA 1c  versus standard care after a 12-month follow-up: mean difference -0.41% for arm 2-arm 1 ( P  = 0.001) and -0.51% for arm 3-arm 1 ( P  ≤ 0.001). DIABEO users included 25.1% of participants in arm 2 and 37.6% in arm 3. In the intention-to-treat population, HbA 1c  changes and incidence of hypoglycemia were comparable between arms.  Conclusions:  A clinical and statistically significant reduction in HbA 1c  levels was found in those patients who used DIABEO at least once a day.",2020,"CONCLUSIONS


A clinical and statistically significant reduction in HbA1c levels was found in those patients who used DIABEO® at least once a day.","['Six hundred sixty-five (665) patients were included in the study', 'patients with a web portal for health care providers', 'Diabetic Patients']",['Mobile App Software with and without Telemonitoring versus Standard Care'],"['HbA1c changes and incidence of hypoglycemia', 'reduction in HbA1c levels', 'HbA1c levels']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",665.0,0.181033,"CONCLUSIONS


A clinical and statistically significant reduction in HbA1c levels was found in those patients who used DIABEO® at least once a day.","[{'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Franc', 'Affiliation': ""Department of Diabetes, Sud-Francilien Hospital, Corbeil-Essonnes, and Centre d'étude et de Recherche pour l'Intensification du Traitement du Diabète (CERITD), Evry, France.""}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Hanaire', 'Affiliation': 'Department of Diabetology, Metabolic Diseases and Nutrition, CHU Toulouse, University of Toulouse, Toulouse, France.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Benhamou', 'Affiliation': 'Department of Diabetology, Pôle DigiDune, University Hospital, Grenoble, France.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Schaepelynck', 'Affiliation': 'Department of Nutrition-Endocrinology-Metabolic Disorders, Marseille University Hospital, Sainte Marguerite Hospital, Marseille, France.'}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Catargi', 'Affiliation': 'Department of Endocrinology and Diabetes, University Hospital, Bordeaux, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Farret', 'Affiliation': 'Department of Endocrinology, Diabetes and Nutrition, University Hospital, Montpellier, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Fontaine', 'Affiliation': 'Department of Diabetology, University Hospital, Lille, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Guerci', 'Affiliation': 'Endocrinology-Diabetes Care Unit, University of Lorraine, Vandoeuvre Lès Nancy, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Reznik', 'Affiliation': 'Department of Endocrinology, University of Caen Côte de Nacre Regional Hospital Center, Caen, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Jeandidier', 'Affiliation': 'Department of Endocrinology, Diabetes and Nutrition, CHU of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Penfornis', 'Affiliation': 'Department of Diabetology, Metabolic Diseases and Nutrition, CHU Toulouse, University of Toulouse, Toulouse, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Borot', 'Affiliation': ""Centre Hospitalier Universitaire Jean Minjoz, Service d'Endocrinologie-Métabolisme et Diabétologie-Nutrition, Besançon, France.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Chaillous', 'Affiliation': 'CHU de Nantes-Hospital Laennec, Saint-Herblain, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Serusclat', 'Affiliation': 'Endocrinology, Diabetology and Nutrition, Clinique Portes du Sud, Venissieux, France.'}, {'ForeName': 'Yacine', 'Initials': 'Y', 'LastName': 'Kherbachi', 'Affiliation': 'Sanofi-Diabetes, Gentilly, France.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': ""d'Orsay"", 'Affiliation': 'Voluntis, Suresnes, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Detournay', 'Affiliation': 'CEMKA-EVAL, Bourg-la-Reine, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'National Association of Telemedicine, Evry, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Charpentier', 'Affiliation': ""Department of Diabetes, Sud-Francilien Hospital, Corbeil-Essonnes, and Centre d'étude et de Recherche pour l'Intensification du Traitement du Diabète (CERITD), Evry, France.""}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0021']
553,30659420,Efficacy and Safety of Premixed Human Insulin Combined with Sulfonylureas in Type 2 Diabetic Patients Previously Poorly Controlled with Insulin.,"INTRODUCTION


Some type 2 diabetes (T2DM) patients treated with premixed insulin alone or in combination with oral glucose-lowering agents (without sulfonylureas) cannot reach the required glucose targets. Clinical studies have demonstrated that diabetes patients treated with sulfonylureas achieve stable glycemic control, with a low hypoglycemic rate. The aim of our study was to evaluate the efficacy and safety of therapy with the combination of premixed insulin and sulfonylureas.
METHODS


A total of 120 patients with T2DM who were unable to achieve glycemic control on premixed human insulin were randomized into four groups, namely, a control group (premixed human insulin only) and three groups receiving combination therapy with premixed human insulin and one of the following sulfonylureas: gliclazide sustained release tablets [Diamicron], glipizide extended release tablets [Glucotrol XL], and glimepiride medium-to-long-acting tablets [Amaryl], with 30 patients in each group. Hemoglobin A1c, blood glucose, and adverse events were assessed at baseline and at the end of the 12-week treatment period.
RESULTS


After treatment for 12 weeks, HbA1c, fasting glucose, and 2-h postprandial glucose levels in the four groups were significantly decreased when compared with baseline (P < 0.05). However, there was no difference between the four groups at the end of the study. In the control group, the daily insulin dose had been significantly increased at the end of the follow-up when compared with baseline (P  < 0.05), while there were no significant changes in premixed insulin dose in the three combination therapy groups. There were no significant differences in adverse events among the four groups.
CONCLUSION


Insulin combined with sulfonylureas could improve glycemic control without increasing daily insulin dose and adverse events. Based on our results, we consider the combination of premixed insulin and sulfonylureas to be effective and safe for the treatment of T2DM.
TRIAL REGISTRATION


This trial was registered as ChiCTR-TRC-14004751. Trial Registration Date: 5 June 2014.",2019,"There were no significant differences in adverse events among the four groups.
","['diabetes patients treated with', '120 patients with T2DM who were unable to achieve glycemic control on premixed human insulin', 'Type 2 Diabetic Patients Previously Poorly Controlled with Insulin']","['premixed insulin and sulfonylureas', 'sulfonylureas', 'glimepiride medium-to-long-acting tablets [Amaryl', 'control group (premixed human insulin only) and three groups receiving combination therapy with premixed human insulin and one of the following sulfonylureas: gliclazide sustained release tablets [Diamicron], glipizide extended release tablets [Glucotrol XL', 'Insulin combined with sulfonylureas', 'premixed insulin alone or in combination with oral glucose-lowering agents (without sulfonylureas', 'Premixed Human Insulin Combined with Sulfonylureas']","['HbA1c, fasting glucose, and 2-h postprandial glucose levels', 'adverse events', 'Hemoglobin A1c, blood glucose, and adverse events', 'Efficacy and Safety', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0795635', 'cui_str': 'insulin (human)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0595112', 'cui_str': 'Amaryl'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0795635', 'cui_str': 'insulin (human)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0017642', 'cui_str': 'Glipizide'}, {'cui': 'C0701228', 'cui_str': 'Glucotrol'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",120.0,0.0328155,"There were no significant differences in adverse events among the four groups.
","[{'ForeName': 'Ying-Hua', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': ""Department of Endocrinology, East Hospital, Tongji University, Shanghai, 200120, People's Republic of China.""}, {'ForeName': 'Hui-Zhi', 'Initials': 'HZ', 'LastName': 'Li', 'Affiliation': ""Department of Endocrinology, East Hospital, Tongji University, Shanghai, 200120, People's Republic of China.""}, {'ForeName': 'Zhao-Sheng', 'Initials': 'ZS', 'LastName': 'Tang', 'Affiliation': ""Department of Endocrinology, East Hospital, Tongji University, Shanghai, 200120, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Department of Endocrinology, East Hospital, Tongji University, Shanghai, 200120, People's Republic of China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Endocrinology, East Hospital, Tongji University, Shanghai, 200120, People's Republic of China. wh1762@easthospital.cn.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': ""Department of Endocrinology, East Hospital, Tongji University, Shanghai, 200120, People's Republic of China. fengbo2010@sohu.com.""}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-019-0564-z']
554,31713753,Transcranial direct current stimulation improves the swallowing function in patients with cricopharyngeal muscle dysfunction following a brainstem stroke.,"OBJECTIVE


This study investigated the effects of transcranial direct current stimulation (tDCS) combined with conventional swallowing training on the swallowing function in brainstem stroke patients with cricopharyngeal muscle dysfunction (CPD).
METHODS


Twenty-eight brainstem stroke patients with CPD were assigned randomly to an anodal tDCS group or a sham tDCS group. The patients received anodal tDCS or sham tDCS over the bilateral oesophageal cortical area combined with simultaneous catheter balloon dilatation and conventional swallowing therapy for 20 days. Swallowing function was assessed using the functional oral intake scale (FOIS) and the functional dysphagia scale (FDS) and by measuring the pharyngoesophageal Segment Opening (PESO) before and immediately after the intervention.
RESULTS


Both groups showed a significant improvement in the FDS, FOIS and PESO scores immediately after the intervention (all p < .005). However, compared with the sham stimulation group, the anodal tDCS group showed greater improvements in the FDS, FOIS and PESO scores immediately after the intervention (all p < .005).
CONCLUSION


The bihemispheric anodal tDCS combined with simultaneous catheter balloon dilatation and conventional swallowing therapy effectively improves the swallowing function in patients with CPD caused by a brainstem stroke. tDCS may be an effective adjuvant therapy in CPD rehabilitation.",2020,"Both groups showed a significant improvement in the FDS, FOIS and PESO scores immediately after the intervention (all p < .005).","['brainstem stroke patients with cricopharyngeal muscle dysfunction (CPD', 'patients with CPD caused by a brainstem stroke', 'Twenty-eight brainstem stroke patients with CPD', 'patients with cricopharyngeal muscle dysfunction following a brainstem stroke']","['bihemispheric anodal tDCS combined with simultaneous catheter balloon dilatation and conventional swallowing therapy', 'tDCS', 'anodal tDCS', 'anodal tDCS or sham tDCS', 'Transcranial direct current stimulation', 'bilateral oesophageal cortical area combined with simultaneous catheter balloon dilatation and conventional swallowing therapy', 'anodal tDCS group or a sham tDCS', 'transcranial direct current stimulation (tDCS) combined with conventional swallowing training']","['FDS, FOIS and PESO scores', 'swallowing function', 'Swallowing function', 'functional oral intake scale (FOIS) and the functional dysphagia scale (FDS) and by measuring the pharyngoesophageal Segment Opening (PESO']","[{'cui': 'C0521542', 'cui_str': 'Brainstem Stroke'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C2001794', 'cui_str': '(BMIM)(TFSI) cpd'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0011167', 'cui_str': 'Swallowing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0222045'}, {'cui': 'C4302242', 'cui_str': 'Functional dysphagia'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]",,0.0176615,"Both groups showed a significant improvement in the FDS, FOIS and PESO scores immediately after the intervention (all p < .005).","[{'ForeName': 'Zhi-Yong', 'Initials': 'ZY', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Fujian Medical University, 20 Chazhong Road, Fuzhou, 350005, China.'}, {'ForeName': 'Jian-Min', 'Initials': 'JM', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Fujian Medical University, 20 Chazhong Road, Fuzhou, 350005, China.'}, {'ForeName': 'Zheng-Kun', 'Initials': 'ZK', 'LastName': 'Lin', 'Affiliation': 'Department of Rehabilitation Medicine, The 909th Hospital, 269 Zhanghua Middle Road, Zhangzhou, 363000, China.'}, {'ForeName': 'Guo-Xin', 'Initials': 'GX', 'LastName': 'Ni', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Fujian Medical University, 20 Chazhong Road, Fuzhou, 350005, China. guoxinni@fjmu.edu.cn.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-019-04120-x']
555,30930051,Is strength training feasible for young people with Prader-Willi syndrome? A phase I randomised controlled trial.,"OBJECTIVE


To investigate the feasibility of progressive resistance training for people with Prader-Willi syndrome (PWS), who have muscle weakness and very low muscle mass.
DESIGN


Randomised controlled trial with concealed allocation, assessor blinding and intention-to-treat analysis.
SETTING


Community gymnasium.
PARTICIPANTS


Sixteen participants with PWS (eight female; mean age 25 years) were randomly assigned with 1:1 allocation to an experimental (n=8) or control group (n=8).
INTERVENTION


Progressive resistance training was performed twice a week for 10 weeks. The training was supervised one-to-one by a physiotherapist and comprised seven exercises. The control group continued their usual activities and were offered the training after follow-up assessment.
MAIN OUTCOME MEASURES


Three domains of feasibility were evaluated: implementation (attendance and adherence), practicality (safety) and limited efficacy testing. Muscle strength (one repetition maximum for chest and leg press), physical function (box stacking test, timed stairs climb), muscle composition (US) and body composition (whole-body DXA scan) were measured before and after the intervention.
RESULTS


Participants attended 92% of scheduled sessions and adhered by progressing their training resistance by 82% (range 60-140%). There was one unexpected serious adverse event unrelated to the intervention and several non-serious expected adverse events related to the intervention. Estimates of standardised mean differences indicated moderate to large effects in favour of the experimental group for arm (0.92, 95%CI -0.11 to 1.95) and leg strength (0.78, 95%CI -0.27 to 1.83). The effect was uncertain for secondary outcomes.
CONCLUSIONS


There is preliminary evidence showing progressive resistance training is feasible for people with Prader-Willi syndrome and may increase muscle strength. Clinical Trial Registration Australia New Zealand Clinical Trials Registry ACTRN12616000107426.",2020,There was one unexpected serious adverse event unrelated to the intervention and several non-serious expected adverse events related to the intervention.,"['Sixteen participants with PWS (eight female; mean age 25 years', 'Community gymnasium', 'people with Prader-Willi syndrome (PWS', 'young people with Prader-Willi syndrome']","['progressive resistance training', 'Progressive resistance training']","['Muscle strength (one repetition maximum for chest and leg press), physical function (box stacking test, timed stairs climb), muscle composition (US) and body composition (whole-body DXA scan', 'implementation (attendance and adherence), practicality (safety) and limited efficacy testing', 'leg strength']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442572', 'cui_str': 'Gymnasium (environment)'}, {'cui': 'C0032897', 'cui_str': 'Labhart-Willi-Prader-Fanconi Syndrome'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed (observable entity)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C2584976', 'cui_str': 'Whole body DXA scan'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}]",16.0,0.0905643,There was one unexpected serious adverse event unrelated to the intervention and several non-serious expected adverse events related to the intervention.,"[{'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Shields', 'Affiliation': 'La Trobe University, Kingsbury Drive, Bundoora, Victoria 3086, Australia. Electronic address: n.shields@latrobe.edu.au.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'The University of Melbourne, Grattan Street, Parkville, Victoria 3010, Australia. Electronic address: k.bennell@unimelb.edu.au.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Radcliffe', 'Affiliation': 'La Trobe University, Kingsbury Drive, Bundoora, Victoria 3086, Australia. Electronic address: J.Radcliffe@latrobe.edu.au.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'Taylor', 'Affiliation': 'La Trobe University, Kingsbury Drive, Bundoora, Victoria 3086, Australia; Eastern Health, 5 Arnold Street, Box Hill, Victoria 3128, Australia. Electronic address: n.taylor@latrobe.edu.au.'}]",Physiotherapy,['10.1016/j.physio.2019.01.016']
556,31887225,"A head-to-head comparison of ixekizumab vs. guselkumab in patients with moderate-to-severe plaque psoriasis: 12-week efficacy, safety and speed of response from a randomized, double-blinded trial.","BACKGROUND


Patients with psoriasis value rapid and complete skin clearance. No head-to-head studies have focused on early responses to interleukin (IL)-17 vs. IL-23 inhibitors.
OBJECTIVES


To compare early and complete skin clearance by the IL-17A inhibitor ixekizumab vs. the IL-23p19 inhibitor guselkumab.
METHODS


IXORA-R, a 24-week, randomized, double-blinded study, enrolled adults with moderate-to-severe plaque psoriasis [static Physician's Global Assessment of Disease (sPGA) score of ≥ 3, Psoriasis Area and Severity Index (PASI) ≥ 12, and ≥ 10% body surface area]. Patients were randomized (1 : 1) to receive the approved dose of subcutaneous ixekizumab or guselkumab. Primary end point was 100% improvement in PASI (PASI 100) at week 12. Major secondary end points included other levels of improved PASI and sPGA at different time points. Comparisons were made using the Cochran-Mantel-Haenszel test with a multiple testing strategy. Nonresponder imputation was used for missing data. After the completion of the study, the final secondary end point (PASI 100 at 24 weeks) and safety data through week 24 will be reported.
RESULTS


In total, 1027 patients were randomized. The primary end point PASI 100 at week 12 was met [215/520 ixekizumab (41%); 126/507 guselkumab (25%); P < 0·001]. All major secondary end points measured up to week 12 were met, including PASI 50 at week 1 and PASI 75 at week 2. Serious adverse event frequency was 3% for each group; no new safety signals were identified.
CONCLUSIONS


Ixekizumab was superior to guselkumab for rapidly improving signs and symptoms in patients with moderate-to-severe plaque psoriasis by week 12. Adverse events were similar to previous ixekizumab and guselkumab studies. Compared with the IL-23 inhibitor guselkumab, ixekizumab can offer complete skin clearance more rapidly to patients with moderate-to-severe plaque psoriasis. What's already known about this topic? Patients with plaque psoriasis desire both high levels of clearance and rapid onset of treatment effects. Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A, has demonstrated greater and faster skin clearance than etanercept and ustekinumab, with consistent long-term efficacy, safety and durability of response. Clinical trial data and systematic reviews have suggested that IL-17 inhibitors can improve a patient's psoriasis more rapidly than IL-23 inhibitors. What does this study add? The head-to-head study design directly compares the efficacy and speed of response of ixekizumab and the IL-23 inhibitor guselkumab in moderate-to-severe plaque psoriasis. The primary end point was met, showing superiority of ixekizumab over guselkumab for achieving complete skin clearance at week 12. The safety profile of ixekizumab was consistent with previous studies. Ixekizumab can deliver patients complete skin clearance and improved quality of life more rapidly than guselkumab.",2020,"No head-to-head studies have focused on early responses to interleukin (IL)-17 versus IL-23 inhibitors.
","['Patients with psoriasis value rapid and complete skin clearance', 'patients with moderate-to-severe plaque psoriasis', 'Patients with Moderate-to-Severe Plaque Psoriasis', ""enrolled adults with moderate-to-severe plaque psoriasis (static Physician's Global Assessment of Disease [sPGA] score of ≥3, Psoriasis Area and Severity Index [PASI] ≥12, and ≥10% body surface area"", '1027 patients were randomised']","['Ixekizumab Versus Guselkumab', 'IL-23 inhibitor guselkumab, ixekizumab', 'subcutaneous ixekizumab or guselkumab', 'Ixekizumab']","['levels of improved PASI and sPGA', 'PASI', 'Adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1027.0,0.26019,"No head-to-head studies have focused on early responses to interleukin (IL)-17 versus IL-23 inhibitors.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, U.S.A.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research, Inc., Waterloo, Ontario, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jarell', 'Affiliation': 'Northeast Dermatology Associates, Portsmouth, NH, U.S.A.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Maari', 'Affiliation': 'Innovaderm Research, Montreal, QC, Canada.'}, {'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Gordon', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, U.S.A.'}, {'ForeName': 'L K', 'Initials': 'LK', 'LastName': 'Ferris', 'Affiliation': 'Department of Dermatology, University of Pittsburgh, Pittsburgh, PA, U.S.A.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Langley', 'Affiliation': 'Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tada', 'Affiliation': 'Department of Dermatology, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Lima', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Elmaraghy', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Renda', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Burge', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bagel', 'Affiliation': 'Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, U.S.A.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of dermatology,['10.1111/bjd.18851']
557,30907155,"The three-dimensional shoulder pain alignment (3D-SPA) mobilization improves pain-free shoulder range, functional reach and sleep following stroke: a pilot randomized control trial.","Background and purpose:  Following a stroke, three-dimensional clavicular/scapular/humeral joint rotations may become restricted and contribute to post-stroke shoulder pain. This study examined whether a treatment group provided with current standard treatment plus the proposed ""Three-dimensional Shoulder Pain Alignment"" mobilization protocol demonstrated improved pain-free shoulder range, functional reach and sleep compared to a control group provided with standard treatment alone. Methods:  In this double-blinded parallel-group randomized control trial, treatment and control subjects with moderate/severe post-stroke upper extremity impairment and shoulder pain were treated 3x/week for 4 weeks. Outcome measures included changes in pain-free three-dimensional clavicular/scapular/humeral range (using computerized digitization), pain during sleep and functional reach (using the Pain Intensity-Numerical Rating Scale), and pain location/prognostic indicators (using the Chedoke-McMaster Stroke Assessment-Shoulder Pain Inventory). Results:  Compared to controls ( n  = 10) the treatment group ( n  = 10) demonstrated significantly improved three-dimensional clavicular/scapular/humeral pain-free range during shoulder flexion and abduction ( p  < 0.05; Hedges  g  > 0.80), large effect sizes for decreased pain during sleep and functional reach to the head and back (OR range: 5.44-21.00), and moderate effect size for improved pain/prognostic indicators (OR = 3.86). Conclusions:  The Three-Dimensional Shoulder Pain Alignment mobilization protocol significantly improved pain-free range of motion, functional reach and pain during sleep in shoulders with moderate/severe post-stroke upper-extremity impairment.Implications for rehabilitationAlthough three-dimensional clavicular/scapular/humeral rotations are an essential component of normal pain-free shoulder range of motion, current guidelines for treatment of post-stroke shoulder pain only includes uni-dimensional mobilizations for joint alignment and pain management.The Three-Dimensional Shoulder Pain Alignment (3D-SPA) mobilization protocol incorporates multi-dimensional mobilizations in various planes of shoulder movement.The current study results demonstrate proof-of-concept regarding the 3D-SPA mobilization, and this approach should be considered as an alternative to the uni-dimensional mobilizations currently used in clinical treatment guidelines for post-stroke shoulder pain.",2020,"The Three-Dimensional Shoulder Pain Alignment mobilization protocol significantly improved pain-free range of motion, functional reach and pain during sleep in shoulders with moderate/severe post-stroke upper-extremity impairment.",['control subjects with moderate/severe post-stroke upper extremity impairment and shoulder pain'],"['dimensional shoulder pain alignment (3D-SPA) mobilization', 'rehabilitation']","['changes in pain-free three-dimensional clavicular/scapular/humeral range (using computerized digitization), pain during sleep and functional reach (using the Pain Intensity-Numerical Rating Scale), and pain location/prognostic indicators (using the Chedoke-McMaster Stroke Assessment-Shoulder Pain Inventory', 'pain-free range of motion, functional reach and pain during sleep', 'pain during sleep and functional reach to the head and back', 'pain-free shoulder range, functional reach and sleep', 'three-dimensional clavicular/scapular/humeral pain-free range during shoulder flexion and abduction']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0587116', 'cui_str': 'During sleep (qualifier value)'}, {'cui': 'C1321055', 'cui_str': 'Functional reach'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}]",,0.0981937,"The Three-Dimensional Shoulder Pain Alignment mobilization protocol significantly improved pain-free range of motion, functional reach and pain during sleep in shoulders with moderate/severe post-stroke upper-extremity impairment.","[{'ForeName': 'Liza A M', 'Initials': 'LAM', 'LastName': 'Pain', 'Affiliation': 'Rehabilitation Sciences Institute, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Baker', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Qazi Zain', 'Initials': 'QZ', 'LastName': 'Sohail', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Hebert', 'Affiliation': 'Toronto Rehabilitation Institute (University Centre), University Health Network, Toronto, Canada.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Zabjek', 'Affiliation': 'Rehabilitation Sciences Institute, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Denyse', 'Initials': 'D', 'LastName': 'Richardson', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Anne M R', 'Initials': 'AMR', 'LastName': 'Agur', 'Affiliation': 'Rehabilitation Sciences Institute, University of Toronto, Toronto, Canada.'}]",Disability and rehabilitation,['10.1080/09638288.2019.1585487']
558,32113823,Effect of liraglutide therapy on serum fetuin A in patients with type 2 diabetes and non-alcoholic fatty liver disease.,"OBJECTIVE


We aimed to compare the effectiveness of liraglutide vs. pioglitazone on hepatic fat content and serum fetuin A levels in patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease.
METHODS


This was a single-center, open-label, prospective, and randomized trial using a parallel design and lasting 24 weeks. Sixty patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease were randomly assigned to the liraglutide and pioglitazone groups on a 1:1 basis using a computer-generated sequence. Fetuin-A levels were determined using enzyme-linked immunosorbent assay. Hepatic fat content was measured using proton  1 H-MRS on a 1.5T whole-body MRI scanner. All analyses were performed with SPSS version 13.0.
RESULTS


In the liraglutide group, fetuin-A levels decreased after 24 weeks (666.1±109.4 vs. 443.7±90.5μg/mL, P<0.05). In the pioglitazone group, fetuin-A levels also decreased after 24 weeks (659.3±111.8 vs. 538.1± 101.0μg/mL, P<0.05) but not to the level of the liraglutide group. The liraglutide treatment resulted in a decrease in  1 H-MRS (24.1±3.0 vs. 20.1±3.8, P<0.05). After 24 weeks, ΔFetuin-A was positively correlated with Δweight (r=0.756, P=0.035), ΔBMI (r=0.653, P=0.006), Δwaist circumference (r=0.767, P=0.010), and Δ 1 H-MRS (r=0.732, P=0.004) in the liraglutide group.
CONCLUSIONS


Liraglutide treatment resulted in a decrease in hepatic fat content and fetuin-A compared with pioglitazone treatment in patients with T2DM and NAFLD. Fetuin-A is positively correlated with weight and hepatic fat content. The reduction in the hepatic fat content may be attributed to weight loss rather than reduction of glucose.",2020,"In the pioglitazone group, fetuin-A levels also decreased after 24 weeks (659.3±111.8 vs. 538.1± 101.0μg/mL, P<0.05) but not to the level of the liraglutide group.","['patients with type 2 diabetes and non-alcoholic fatty liver disease', 'patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease', 'patients with T2DM and NAFLD', 'Sixty patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease']","['Liraglutide', 'liraglutide and pioglitazone', 'pioglitazone', 'liraglutide therapy', 'liraglutide vs. pioglitazone', 'liraglutide']","['ΔBMI', '1 H-MRS', 'Δwaist circumference', 'fetuin-A levels', 'hepatic fat content', 'Hepatic fat content', 'hepatic fat content and serum fetuin A levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0051477', 'cui_str': 'AHSG Protein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C3160817', 'cui_str': 'Serum fetuin-A'}]",60.0,0.0213034,"In the pioglitazone group, fetuin-A levels also decreased after 24 weeks (659.3±111.8 vs. 538.1± 101.0μg/mL, P<0.05) but not to the level of the liraglutide group.","[{'ForeName': 'Ling-Yun', 'Initials': 'LY', 'LastName': 'Zhang', 'Affiliation': 'Department of General Medicine, Yantai Affiliated Hospital of Binzhou Medical University, Yantai Shandong, China. Electronic address: dhbandzly0603@126.com.'}, {'ForeName': 'Xiao-Ning', 'Initials': 'XN', 'LastName': 'Qu', 'Affiliation': 'Department of General Medicine, Yantai Affiliated Hospital of Binzhou Medical University, Yantai Shandong, China.'}, {'ForeName': 'Zheng-Yao', 'Initials': 'ZY', 'LastName': 'Sun', 'Affiliation': 'Department of General Medicine, Yantai Affiliated Hospital of Binzhou Medical University, Yantai Shandong, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of General Medicine, Yantai Affiliated Hospital of Binzhou Medical University, Yantai Shandong, China.'}]",Clinics and research in hepatology and gastroenterology,['10.1016/j.clinre.2020.01.007']
559,31706460,Implementation and Evaluation of the Abriendo Caminos Program: A Randomized Control Trial Intervention for Hispanic Children and Families.,"OBJECTIVE


To describe the methodology of a family-focused, culturally tailored program, Abriendo Caminos, for the prevention of excess weight gain in children.
DESIGN


Randomized control trial with outcome assessment at pretest, posttest, and 6 months after intervention or abbreviated-attention control group.
SETTING


Community setting across 5 sites (Illinois, California, Iowa, Texas, and Puerto Rico).
PARTICIPANTS


Mexican American and Puerto Rican families (parent and 1 child aged 6-18 years). A sample size of 100 families (50 intervention and 50 control) per site (n = 500) will provide adequate power to detect intervention effects.
INTERVENTION


Families will participate in 6 weekly, 2-hour group workshops on nutrition education through combined presentations and activities, family wellness, and physical activity.
MAIN OUTCOME MEASURES


The primary outcome is prevention of excess weight gain in children; secondary outcomes include changes in child diet, specifically fruit, vegetable, and sugar-sweetened beverage consumption, and changes in parents' diets and improvement of family routines. Measures will be collected at baseline, postintervention, and 6 months after.
ANALYSIS


Modeling to assess changes within and between experimental groups will be checked using standard methods including assessment of model fit, influence diagnostics, adjusted R 2 , and multicollinearity. Significance of effects will be examined using Type III tests.",2019,"A sample size of 100 families (50 intervention and 50 control) per site (n = 500) will provide adequate power to detect intervention effects.
","['Mexican American and Puerto Rican families (parent and 1 child aged 6-18 years', 'Hispanic Children and Families', 'Community setting across 5 sites (Illinois, California, Iowa, Texas, and Puerto Rico', 'children', '100 families (50 intervention and 50 control) per site (n\u202f=\u202f500']","['abbreviated-attention control group', 'Abriendo Caminos Program']","[""prevention of excess weight gain in children; secondary outcomes include changes in child diet, specifically fruit, vegetable, and sugar-sweetened beverage consumption, and changes in parents' diets and improvement of family routines""]","[{'cui': 'C0025884', 'cui_str': 'Chicanas'}, {'cui': 'C0034043', 'cui_str': 'Puerto Ricans'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]",100.0,0.100795,"A sample size of 100 families (50 intervention and 50 control) per site (n = 500) will provide adequate power to detect intervention effects.
","[{'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Hannon', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Teran-Garcia', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL; Department of Human Development and Family Studies, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL; University of Illinois Extension, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL; Family Resiliency Center, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL. Electronic address: teranmd@illinois.edu.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Nickols-Richardson', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL; University of Illinois Extension, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL; Department of Food Science and Human Nutrition, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL.'}, {'ForeName': 'Salma M A', 'Initials': 'SMA', 'LastName': 'Musaad', 'Affiliation': 'Department of Human Development and Family Studies, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL; Family Resiliency Center, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Villegas', 'Affiliation': 'Department of Human Development and Family Studies, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Hammons', 'Affiliation': 'Child and Family Science, California State University, Fresno, CA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wiley', 'Affiliation': 'Department of Human Development and Family Studies, Auburn University, Auburn, AL; Child and Family Science, California State University, Fresno, CA.'}, {'ForeName': 'Barbara H', 'Initials': 'BH', 'LastName': 'Fiese', 'Affiliation': 'Department of Human Development and Family Studies, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL; Family Resiliency Center, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.08.011']
560,30902428,Changes in Weight and Health-Related Behavior Using Smartphone Applications in Patients With Colorectal Polyps.,"OBJECTIVE


To assess the effectiveness of using a smartphone application for weight loss as well as a change in health-related behavior in patients with colorectal polyps over 3 months.
DESIGN


Randomized, controlled pilot trial.
SETTING


The Department of Family Medicine, Myongji Hospital, Hanyang University College of Medicine, Goyang, Korea.
PARTICIPANTS


Adults aged 25-65 years who were diagnosed with colorectal polyps.
INTERVENTIONS


A comparison of smartphone application data, with exercise and food intake diary data over 3 months.
MAIN OUTCOME MEASURES


Primary outcomes were weight reduction and an increase in physical activity. Secondary outcomes included changes in dietary intake, such as that of vegetables, fruits, and fatty food.
ANALYSIS


Student t test was used for continuous variables, and chi-square test for categorical variables.
RESULTS


Participants using the smartphone application experienced significant weight reduction compared with participants in the control group (mean change = -1.25 vs -0.42 kg; SD = 0.42 vs 1.23 kg). Moreover, use of the application and strict adherence to it significantly increased the level of physical activity (mean change = 1.57 vs 0.71 strenuous exercises/wk; SD = 1.09 vs 0.96 strenuous exercise/wk).
CONCLUSIONS AND IMPLICATIONS


Smartphone applications could be potential tools for weight control and physical activity in patients with colorectal polyps. Future larger randomized, controlled trials over a prolonged period are warranted to confirm these findings.",2019,"RESULTS


Participants using the smartphone application experienced significant weight reduction compared with participants in the control group (mean change = -1.25 vs -0.42 kg;","['Patients With Colorectal Polyps', 'The Department of Family Medicine, Myongji Hospital, Hanyang University College of Medicine, Goyang, Korea', 'Adults aged 25-65 years who were diagnosed with colorectal polyps', 'patients with colorectal polyps over 3 months', 'patients with colorectal polyps']",['smartphone application'],"['level of physical activity', 'weight loss', 'changes in dietary intake, such as that of vegetables, fruits, and fatty food', 'weight reduction', 'weight reduction and an increase in physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0453819', 'cui_str': 'Fatty food (substance)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.103318,"RESULTS


Participants using the smartphone application experienced significant weight reduction compared with participants in the control group (mean change = -1.25 vs -0.42 kg;","[{'ForeName': 'Ki-Won', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Family Medicine, Myongji Hospital, Hanyang University College of Medicine, Goyang, Gyeonggi Province, Republic of Korea.'}, {'ForeName': 'Hong-Bae', 'Initials': 'HB', 'LastName': 'Kim', 'Affiliation': 'Department of Family Medicine, Myongji Hospital, Hanyang University College of Medicine, Goyang, Gyeonggi Province, Republic of Korea; Department of Family Medicine, School of Medicine, Yonsei University, Seoul, Republic of Korea. Electronic address: hongbai96@mjh.or.kr.'}, {'ForeName': 'Sang-Hwa', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Family Medicine, Myongji Hospital, Hanyang University College of Medicine, Goyang, Gyeonggi Province, Republic of Korea.'}, {'ForeName': 'Heon-Kyun', 'Initials': 'HK', 'LastName': 'Ha', 'Affiliation': 'Department of Surgery, Myongji Hospital, Goyang, Gyeonggi Province, Republic of Korea.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.02.002']
561,30848415,The Influence of Treatment Engagement on Positive Outcomes in the Context of a School-Based Intervention for Students with Externalizing Behavior Problems.,"We examined the stability of and cross-influences between externalizing behaviors and intervention engagement among children participating in a randomized clinical trial of an intervention for disruptive behavioral youth. Analyses also accounted for the influence of caregiver depression, family relationship quality, and sociodemographic factors (race, income) on the relationship between behaviors and intervention engagement. Analyses were based on 118 children participating in the Coping Power intervention. Composite variables were created to represent externalizing behaviors and intervention engagement constructs. Associations between these composite variables were examined over 24 treatment sessions. Findings indicated a regressive relationship among externalizing behaviors, i.e., baseline externalizing behaviors were positively associated with immediate follow-up behaviors. There were also dynamic relationships observed among engagement constructs. Notably, engagement with in-session activities during sessions 1-8 was positively associated with out-of-session activity engagement during the same treatment time period. Engagement with out-of-session activities during sessions 1-8 was positively associated with in-session activity engagement during sessions 9-16, indicating a complete mediation between early and middle in-session engagement through the mechanism of early out-of-session engagement. A crosslag relationship was observed: middle in-session engagement was negatively associated with externalizing behaviors at immediate follow-up. Finally, an interaction of race by income on immediate follow-up externalizing behaviors was observed, such that Black children's externalizing behaviors remain static regardless of income level while White children's behaviors decreased with higher income. Our findings support the contention that focusing on intervention engagement may be especially important in prevention interventions.",2019,A crosslag relationship was observed: middle in-session engagement was negatively associated with externalizing behaviors at immediate follow-up.,"['children participating in a randomized clinical trial of an intervention for disruptive behavioral youth', '118 children participating in the Coping Power intervention', 'Students with Externalizing Behavior Problems']",[],"['caregiver depression, family relationship quality, and sociodemographic factors (race, income', 'baseline externalizing behaviors', 'externalizing behaviors']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",[],"[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0015608', 'cui_str': 'Family Relationship'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",118.0,0.0222043,A crosslag relationship was observed: middle in-session engagement was negatively associated with externalizing behaviors at immediate follow-up.,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Lindsey', 'Affiliation': 'McSilver Institute for Poverty Policy and Research, Silver School of Social Work, New York University, New York, NY, USA. Michael.Lindsey@nyu.edu.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Romanelli', 'Affiliation': 'McSilver Institute for Poverty Policy and Research, Silver School of Social Work, New York University, New York, NY, USA.'}, {'ForeName': 'Mesha L', 'Initials': 'ML', 'LastName': 'Ellis', 'Affiliation': 'Ellis Evaluation & Consulting Services, Atlanta, GA, USA.'}, {'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Barker', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK.""}, {'ForeName': 'Caroline L', 'Initials': 'CL', 'LastName': 'Boxmeyer', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, The University of Alabama, Tuscaloosa, AL, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Lochman', 'Affiliation': 'Department of Psychology, The University of Alabama, Tuscaloosa, AL, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-019-00525-6']
562,30887050,Reduction in acute kidney injury stage predicts survival in patients with type-1 hepatorenal syndrome.,"BACKGROUND


Hepatorenal syndrome type 1 (HRS-1), a form of acute kidney injury (AKI) in cirrhosis, has a median survival of days to weeks if untreated. The impact of reduction in AKI stage on overall survival in cirrhosis, independent of HRS reversal, is unclear.
METHODS


The Randomized, placEbo-controlled, double-blind study to confirm the reVERSal of HRS-1 with terlipressin study assessed terlipressin versus placebo, both with albumin, as treatment for HRS-1 for ≤14 days. Renal dysfunction severity was categorized by AKI stage at enrollment. Baseline patient characteristics were evaluated as predictors of AKI improvement using a multivariate model; the association between AKI stage reduction and 90-day survival was assessed using linear regression.
RESULTS


A total of 184 patients (terlipressin: n = 91; placebo: n = 93) with similar numbers in AKI Stages 1-3 (terlipressin/placebo, Stage 1: n = 25/26; Stage 2: n = 35/33; Stage 3: n = 31/34) were included. Predictors of AKI improvement were absence of alcoholic hepatitis, baseline serum creatinine and male gender. Overall survival was not significantly different across AKI stages (range 53-65%). In patients with no AKI worsening, 90-day survival was consistently better when AKI improved independent of HRS reversal, regardless of the initial AKI stage, with patients with Stage 1 at initial diagnosis achieving the greatest clinical benefit. A significant association was observed between AKI reduction and overall 90-day survival (P = 0.0022).
CONCLUSIONS


A reduction in AKI stage, independent of HRS reversal, was sufficient to improve overall survival in patients with HRS-1. The goal for HRS-1 treatment should be less stringent than absolute HRS reversal.",2020,"A reduction in AKI stage, independent of HRS reversal, was sufficient to improve overall survival in patients with HRS-1.","['184 patients (terlipressin: n\xa0=\xa091', '35/33; Stage 3: n\xa0=\xa031/34) were included', '25/26; Stage 2: n\xa0', 'Hepatorenal syndrome type 1', 'HRS-1 for ≤14\u2009days', 'patients with HRS-1', 'patients with type-1 hepatorenal syndrome']","['terlipressin versus placebo, both with albumin', 'placEbo', 'placebo: n\xa0=\xa093) with similar numbers in AKI Stages 1-3 (terlipressin/placebo, Stage 1: n\xa0']","['AKI stage reduction and 90-day survival', 'Renal dysfunction severity', 'Overall survival', 'alcoholic hepatitis, baseline serum creatinine and male gender', '90-day survival', 'AKI reduction and overall 90-day survival', 'overall survival']","[{'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0145185', 'cui_str': 'terlipressin'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0019212', 'cui_str': 'Hepatorenal Syndrome'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0145185', 'cui_str': 'terlipressin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}]","[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019187', 'cui_str': 'Hepatitis, Alcoholic'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]",184.0,0.62913,"A reduction in AKI stage, independent of HRS reversal, was sufficient to improve overall survival in patients with HRS-1.","[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Boyer', 'Affiliation': 'Department of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Gastroenterology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Pappas', 'Affiliation': 'Scientific Affairs, Orphan Therapeutics, Lebanon, NJ, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Escalante', 'Affiliation': 'Biometrics, Mallinckrodt Pharmaceuticals, Bedminister, NJ, USA.'}, {'ForeName': 'Khurram', 'Initials': 'K', 'LastName': 'Jamil', 'Affiliation': 'Scientific Affairs, Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz048']
563,30900195,A Virtual Resiliency Intervention for Parents of Children with Autism: A Randomized Pilot Trial.,"Parents of children with Autism experience high levels of stress. Resiliency is the ability to cope and adapt when faced with stressful events. This randomized, waitlist controlled pilot trial examines the feasibility, acceptability, and preliminary efficacy of an adapted virtual mind-body group intervention for parents of children with ASD. The intervention was feasible and acceptable. The immediate treatment group showed no difference in distress and greater improvement in resiliency and stress reactivity/coping relative to the delayed treatment group, (M difference 5.78; p = .038 and M difference 7.78; p = .001 respectively). Findings showed promising feasibility, acceptability, and preliminary efficacy for parents of children with ASD.",2020,"The immediate treatment group showed no difference in distress and greater improvement in resiliency and stress reactivity/coping relative to the delayed treatment group, (M difference 5.78; p = .038 and M difference 7.78; p = .001 respectively).","['parents of children with ASD', 'Parents of children with Autism experience high levels of stress', 'Parents of Children with Autism']","['adapted virtual mind-body group intervention', 'Virtual Resiliency Intervention']","['resiliency and stress reactivity/coping relative', 'distress']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",,0.0497679,"The immediate treatment group showed no difference in distress and greater improvement in resiliency and stress reactivity/coping relative to the delayed treatment group, (M difference 5.78; p = .038 and M difference 7.78; p = .001 respectively).","[{'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Kuhlthau', 'Affiliation': 'Department of Pediatrics, Massachusetts General Hospital, 125 Nashua Street Suite 860, Boston, MA, 02114, USA. kkuhlthau@mgh.harvard.edu.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Luberto', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Traeger', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Millstein', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Giselle K', 'Initials': 'GK', 'LastName': 'Perez', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Olivia J', 'Initials': 'OJ', 'LastName': 'Lindly', 'Affiliation': 'Department of Pediatrics, Massachusetts General Hospital, 125 Nashua Street Suite 860, Boston, MA, 02114, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Chad-Friedman', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Proszynski', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-019-03976-4']
564,31375361,Effects of Culturally Tailored Nutrition Education on Dietary Quality of Hispanic Mothers: A Randomized Control Trial.,"OBJECTIVE


To assess whether participation in a culturally tailored nutrition education program increases diet quality of Hispanic mothers.
DESIGN


A randomized controlled trial.
SETTING


Community centers and universities.
PARTICIPANTS


Sixty-five mothers (35 in experimental group, 30 in control group) completed pre- and postworkshop surveys. Eligibility criteria included being of Mexican or Puerto Rican descent and having a child between the ages of 6 and 18 years who could participate in the workshops with the parent.
INTERVENTION


Families in the experimental group participated in a 6-week workshop series that included weekly nutrition education classes.
MAIN OUTCOME MEASURE


Diet quality was assessed by the Rate Your Plate questionnaire.
ANALYSIS


Repeated measures ANOVA was used to compare differences between the experimental and control groups. A Wilcoxon signed rank test was conducted to test for significant shifts in categorization pre- and postprogram.
RESULTS


There was a significant change in diet quality categorization after participating in the workshops (P < .001, effect size 0.39). No changes were found in the control group.
CONCLUSIONS AND IMPLICATIONS


Abriendo Caminos was effective at increasing the diet quality of Hispanic mothers who participated the most in the program. More research is needed in this at-risk population to determine the relationships among nutrition knowledge, diet quality, and achievement of healthy weight.",2019,"There was a significant change in diet quality categorization after participating in the workshops (P < .001, effect size 0.39).","['Hispanic mothers who participated the most in the program', 'Hispanic mothers', 'Community centers and universities', 'Eligibility criteria included being of Mexican or Puerto Rican descent and having a child between the ages of 6 and 18 years who could participate in the workshops with the parent', 'Hispanic Mothers', 'Sixty-five mothers (35 in experimental group, 30 in control group) completed pre- and postworkshop surveys']","['Culturally Tailored Nutrition Education', 'culturally tailored nutrition education program']","['diet quality', 'Diet quality', 'Rate Your Plate questionnaire', 'diet quality categorization']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0034043', 'cui_str': 'Puerto Ricans'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",65.0,0.0442626,"There was a significant change in diet quality categorization after participating in the workshops (P < .001, effect size 0.39).","[{'ForeName': 'Amber J', 'Initials': 'AJ', 'LastName': 'Hammons', 'Affiliation': 'Department of Child and Family Science, California State University, Fresno, CA. Electronic address: ahammons@csufresno.edu.'}, {'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Hannon', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Teran-Garcia', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL; Department of Human Development and Family Studies, University of Illinois, Urbana-Champaign, IL; University of Illinois Extension, University of Illinois, Urbana-Champaign, IL; Family Resiliency Center, University of Illinois, Urbana-Champaign, IL.'}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Barragan', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Villegas', 'Affiliation': 'Department of Human Development and Family Studies, University of Illinois, Urbana-Champaign, IL.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wiley', 'Affiliation': 'Department of Human Development and Family Studies, Auburn University, Auburn, AL.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Fiese', 'Affiliation': 'Department of Human Development and Family Studies, University of Illinois, Urbana-Champaign, IL; Family Resiliency Center, University of Illinois, Urbana-Champaign, IL.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.06.017']
565,31736187,Stress-related suppression of peripheral cytokines predicts future relapse in alcohol-dependent individuals with and without subclinical depression.,"Chronic alcohol abuse and depressive symptoms are both associated with peripheral cytokine changes. Despite this, cytokine adaptations have not been assessed in co-morbid populations or prospectively as predictors of relapse. We examine cytokine responses to stress in alcohol-dependent individuals and social drinkers, both with and without subclinical depression. We also examine the potential link between cytokine adaptations in response to stress and prospective alcohol relapse risk. Thirty-three, alcohol-dependent individuals (21 with and 12 without high depressive symptoms) and 37 controls (16 with and 21 without high depressive symptoms) were exposed to two 5-minute personalized guided imagery conditions (stress and neutral) across consecutive days in a randomized and counterbalanced order. Alcohol craving and serum measures of tumor necrosis factor alpha (TNFα), tumor necrosis factor receptor 1 (TNFR1), interleukin-6 (IL-6), and interleukin-1 receptor antagonist (IL-1ra) were collected prior to and following imagery exposure. Following treatment discharge, follow-up interviews were conducted over 90 days to assess relapse. Dampened IL-1ra and IL-6 in response to stress was observed as a function of alcohol dependence and not moderated by depressive symptoms. Lower levels of IL-6 following stress also predicted greater drinking days following treatment. Conversely, high depressive symptomatology was associated solely with pro-inflammatory adaptations. Stress-related suppression of TNFα predicted drinking severity only in alcohol-dependent individuals with subclinical depression, and suppressed TNFR1 following stress was only seen in individuals with subclinical depression. Stress-induced suppression of pro-inflammatory TNF markers may indicate a risk factor for alcohol-dependent individuals with co-occurring depressive symptoms.",2019,"Alcohol craving and serum measures of tumor necrosis factor alpha (TNFα), tumor necrosis factor receptor 1 (TNFR1), interleukin-6 (IL-6), and interleukin-1 receptor antagonist (IL-1ra) were collected prior to and following imagery exposure.","['alcohol-dependent individuals with and without subclinical depression', 'Thirty-three, alcohol-dependent individuals (21 with and 12 without high depressive symptoms) and 37 controls (16 with and 21 without high depressive symptoms', 'alcohol-dependent individuals and social drinkers, both with and without subclinical depression']",['5-minute personalized guided imagery conditions (stress and neutral'],"['Chronic alcohol abuse and depressive symptoms', 'Alcohol craving and serum measures of tumor necrosis factor alpha (TNFα), tumor necrosis factor receptor 1 (TNFR1), interleukin-6 (IL-6), and interleukin-1 receptor antagonist (IL-1ra']","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0337676', 'cui_str': 'Social drinker (finding)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0077503', 'cui_str': 'TNF Receptors'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2317059', 'cui_str': 'Interleukin 1 receptor antagonist product'}, {'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}]",,0.0329056,"Alcohol craving and serum measures of tumor necrosis factor alpha (TNFα), tumor necrosis factor receptor 1 (TNFR1), interleukin-6 (IL-6), and interleukin-1 receptor antagonist (IL-1ra) were collected prior to and following imagery exposure.","[{'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Fox', 'Affiliation': 'Department of Psychiatry, School of Medicine, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Verica', 'Initials': 'V', 'LastName': 'Milivojevic', 'Affiliation': 'The Yale Stress Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'MacDougall', 'Affiliation': 'The Yale Stress Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'LaVallee', 'Affiliation': 'The Yale Stress Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Simpson', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Gustavo A', 'Initials': 'GA', 'LastName': 'Angarita', 'Affiliation': 'Clinical Neuroscience Research Unit, The Connecticut Mental Health Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Rajita', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'The Yale Stress Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}]",Addiction biology,['10.1111/adb.12832']
566,32079999,The Influence of a Positive Empathetic Interaction on Conditioned Pain Modulation and Manipulation-induced Analgesia in People With Lateral Epicondylalgia.,"OBJECTIVE


Conditioned pain modulation (CPM) and manipulation-induced analgesia (MIA) are 2 forms of endogenous analgesia. Many forms of analgesia can be influenced by the nature of the patient-clinician interaction. The aim of this study was to evaluate the influence of an empathetic and supportive interaction on CPM and MIA in people with lateral epicondylalgia (LE).
MATERIAL AND METHODS


In a double-blind, randomized, controlled trial, 68 participants with LE were assigned to 2 groups: the empathetic and neutral interaction groups. The interactions were carried out by a trained, professional role-play actor, playing the part of a research assistant. The research assistant actor spent 15 minutes before CPM and MIA assessment interacting with the participants in an empathetic or neutral manner. Immediately after the interaction, a blinded assessor measured pressure pain threshold at the symptomatic elbow and ipsilateral wrist during CPM and MIA testing. Linear mixed models were used to evaluate differences in CPM and MIA responses between the interaction groups.
RESULTS


There was a significant difference in Consultation and Relational Empathy scores between the groups (P<0.001), indicating that the intervention group experienced a more empathic interaction. Both groups showed a significant increase in pressure pain threshold measures, indicative of a CPM and MIA analgesic response (P<0.001), however, the analgesic responses were greater in the group that had experienced a supportive, empathetic interaction (post CPM, wrist: P<0.001; elbow: P=0.001) (post MIA wrist: P<0.001; elbow: P=0.001).
DISCUSSION


A single session of empathetic interaction positively influenced both CPM and MIA responses in people with LE.",2020,"Both groups showed a significant increase in PPT measures, indicative of a CPM and MIA analgesic response (P<0.001), however the analgesic responses were greater in the group that had experienced a supportive, empathetic interaction (post CPM, wrist: P<0.001; elbow: P=0.001), (post MIA wrist: P=<0.001; elbow: P=0.001).
","['People with Lateral Epicondylalgia', 'people with LE', 'people with Lateral Epicondylalgia (LE', '68 participants with LE']","['Positive Empathetic Interaction', 'Conditioned pain modulation (CPM) and manipulation induced analgesia (MIA']","['pressure pain threshold (PPT', 'analgesic responses', 'empathic interaction', 'PPT measures, indicative of a CPM and MIA analgesic response', 'CARE scores', 'CPM and MIA responses']","[{'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",68.0,0.101625,"Both groups showed a significant increase in PPT measures, indicative of a CPM and MIA analgesic response (P<0.001), however the analgesic responses were greater in the group that had experienced a supportive, empathetic interaction (post CPM, wrist: P<0.001; elbow: P=0.001), (post MIA wrist: P=<0.001; elbow: P=0.001).
","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Muhsen', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Moss', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Gibson', 'Affiliation': 'School of Physiotherapy, University of Notre Dame Australia, Fremantle, WA, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Walker', 'Affiliation': 'Chiropractic program, College of Science, Health, Engineering and Education, Murdoch University.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jacques', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schug', 'Affiliation': 'Discipline of Anaesthesiology, University of Western Australia, Perth.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Wright', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000822']
567,30870136,Fenofibrate therapy to lower serum triglyceride concentrations in persons with spinal cord injury: A preliminary analysis of its safety profile.,"Context:  Fenofibrate is used to treat elevated serum triglyceride (TG) concentrations (e.g. ≥150 mg/dl). The lipoprotein profile of most individuals with spinal cord injury (SCI) would not satisfy conventional criteria to initiate lipid-lowering therapies. Serum TG concentrations of 115 and 137 mg/dl were recently identified as potential intervention thresholds for persons with a SCI proximal to the 4th and below the 5th thoracic vertebrae, respectively. Fenofibrate therapy has not been tested for safety in persons with SCI.  Methods:  An open-label trial was performed in 15 persons with SCI to determine the safety profile of 4 months of once-daily fenofibrate (145 mg tablet) treatment when initiated using modified intervention thresholds. Fasting blood tests and a review of systems were performed monthly to determine changes in liver and kidney function, as well as overall health status.  Results:  Fifteen subjects participated and 4 had an adverse event (e.g. 2 with gastrointestinal distress; 2 with elevated liver enzymes). Three subjects discontinued the trial within the first month and one participant remained in the trial with no further adverse events. Two participants were discontinued from fenofibrate after 2 months after not responding to treatment, as per protocol, and 10 participants completed the 4-month trial without experiencing an adverse event.  Conclusion:  In persons with SCI, 4 months of fenofibrate therapy initiated at lower threshold serum TG concentrations did not result in an increased incidence of adverse events compared to that reported in the general population. Fenofibrate therapy appears to be well tolerated in persons with SCI.",2020,"In persons with SCI, 4 months of fenofibrate therapy initiated at lower threshold serum TG concentrations did not result in an increased incidence of adverse events compared to that reported in the general population.","['15 persons with SCI', 'persons with SCI', 'persons with spinal cord injury', 'individuals with spinal cord injury (SCI', 'Fifteen subjects participated and 4 had an adverse event (e.g. 2 with gastrointestinal distress; 2 with elevated liver enzymes']","['Fenofibrate therapy', 'Fenofibrate', 'fenofibrate']","['serum TG concentrations', 'Fasting blood tests', 'adverse events', 'serum triglyceride concentrations', 'serum triglyceride (TG) concentrations', 'Serum TG concentrations']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0235996', 'cui_str': 'Hepatic enzyme increased'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}]",15.0,0.0333488,"In persons with SCI, 4 months of fenofibrate therapy initiated at lower threshold serum TG concentrations did not result in an increased incidence of adverse events compared to that reported in the general population.","[{'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'La Fountaine', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical, Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Cirnigliaro', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical, Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Hobson', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical, Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Lombard', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical, Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Adam F', 'Initials': 'AF', 'LastName': 'Specht', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical, Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Dyson-Hudson', 'Affiliation': 'Kessler Foundation, West Orange, New Jersey, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Bauman', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical, Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, New York, USA.'}]",The journal of spinal cord medicine,['10.1080/10790268.2019.1581694']
568,30870245,Predictors of Exercise Training and Physical Activity Adherence in People Recently Hospitalized With Heart Failure: A BRIEF REPORT.,"PURPOSE


For individuals with heart failure (HF), frequent attendance at exercise training programs and meeting physical activity (PA) guidelines are significantly associated with improvements in 6-min walk distance. Despite the evidence, adherence to exercise interventions remains poor. The aim of this study was to identify predictors of these 2 variables in patients recently hospitalized with HF.
METHODS


In this substudy of the Exercise Joins Education: Combined Therapy to Improve Outcomes in Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk. Intervention group participants additionally undertook twice weekly supervised exercise training. Primary outcomes were frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines (150 min/wk of moderate intensity exercise) at 12 wk. Participant and clinical characteristics were analyzed using a logistic regression model to identify significant predictors of each outcome.
RESULTS


A total of 278 participants provided PA data and 140 contributed attendance data. New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03). Predictors of meeting PA guidelines at follow-up included new HF diagnosis (OR = 2.4; 95% CI, 1.2-4.8, P = .013), and being physically active at baseline (OR = 2.7; 95% CI, 1.3-5.6; P = .007). Gender, symptom severity, multimorbidity, and disability were not significantly associated with either outcome in multivariate analysis.
CONCLUSION


To improve adherence, specific strategies may be required for patients with decompensated HF and those physically inactive at time of referral.",2019,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","['278 participants provided PA data and 140 contributed attendance data', 'Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk', 'individuals with heart failure (HF', 'patients with decompensated HF and those physically inactive at time of referral', 'People Recently Hospitalized With Heart Failure']","['Exercise Training and Physical Activity Adherence', 'supervised exercise training']","['Gender, symptom severity, multimorbidity, and disability', 'frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines', 'frequent program attendance']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0336969', 'cui_str': 'Ejection (qualifier value)'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0699752', 'cui_str': 'Review of (contextual qualifier) (qualifier value)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",278.0,0.0700865,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Adsett', 'Affiliation': ""Heart Support Service (Ms Adsett) and Departments of Physiotherapy (Ms Adsett) and Internal Medicine and Aged Care (Dr Mudge), Royal Brisbane and Women's Hospital, Brisbane, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Australia (Ms Adsett and Dr Morris); Menzies Health Institute, Queensland, Australia (Ms Adsett and Dr Morris); Metro North Hospital and Health Service, The Prince Charles Hospital, Allied Health Research Collaborative, Queensland, Australia (Dr Morris); and University of Queensland Faculty of Medicine, Brisbane, Queensland, Australia (Dr Mudge).""}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Mudge', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000407']
569,30822378,Economic evaluation of a tailored therapist-guided internet-based cognitive behavioural treatment for patients with psoriasis: a randomized controlled trial.,,2019,,['patients with psoriasis'],['tailored therapist-guided internet-based cognitive behavioural treatment'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.151877,,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'van Beugen', 'Affiliation': 'Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ferwerda', 'Affiliation': 'Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'van Middendorp', 'Affiliation': 'Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Smit', 'Affiliation': 'Department of Dermatology, Rijnstate Hospital, Velp, the Netherlands.'}, {'ForeName': 'M E J', 'Initials': 'MEJ', 'LastName': 'Zeeuwen-Franssen', 'Affiliation': 'Department of Dermatology, Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands.'}, {'ForeName': 'E B M', 'Initials': 'EBM', 'LastName': 'Kroft', 'Affiliation': 'Department of Dermatology, Ziekenhuisgroep Twente, Almelo, the Netherlands.'}, {'ForeName': 'E M G J', 'Initials': 'EMGJ', 'LastName': 'de Jong', 'Affiliation': 'Department of Dermatology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'P C M', 'Initials': 'PCM', 'LastName': 'van de Kerkhof', 'Affiliation': 'Department of Dermatology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Kievit', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'A W M', 'Initials': 'AWM', 'LastName': 'Evers', 'Affiliation': 'Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}]",The British journal of dermatology,['10.1111/bjd.17848']
570,30836013,Depression-related stigma: comparing laypersons' stigmatic attributions towards younger and older persons.,"Objectives:  A great amount of interest has been invested in the understanding of public stigma toward persons with depression. However, published studies were mostly restricted to the study of stigma toward a young person with depression. This study was aimed to compare public stigma towards a younger and an older person with depression among a sample of the Jewish adult population in Israel. Method:  Computerized phone interviews were conducted with 393 participants (aged 18+) who were randomly presented with one of two vignettes describing a younger or an older person with depression. Results:  Overall, the participants reported low levels of stigma towards a person with depression. With the exception of pity, the younger person elicited higher levels of stigmatic attributions in all dimensions (cognitive, emotional, and behavioral) in comparison to the older person. Regardless of the age of the person with depression, only emotional reactions - but not cognitive attributions-were associated with discriminatory attributions. Conclusion:  Our findings stress the importance of paying attention to the age of the person with depression in anti-stigma campaigns and studies to better understand the meaning and consequences of depression-stigma.",2020,"With the exception of pity, the younger person elicited higher levels of stigmatic attributions in all dimensions (cognitive, emotional, and behavioral) in comparison to the older person.","['public stigma towards a younger and an older person with depression among a sample of the Jewish adult population in Israel', 'persons with depression', 'younger and older persons', '393 participants (aged 18+) who were randomly presented with one of two vignettes describing a younger or an older person with depression']",[],"['Depression-related stigma', 'stigmatic attributions']","[{'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0178443', 'cui_str': 'Jewish, follower of religion (person)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C4517754', 'cui_str': 'Three hundred and ninety-three'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]",[],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]",393.0,0.0508273,"With the exception of pity, the younger person elicited higher levels of stigmatic attributions in all dimensions (cognitive, emotional, and behavioral) in comparison to the older person.","[{'ForeName': 'Perla', 'Initials': 'P', 'LastName': 'Werner', 'Affiliation': 'Department of Community Mental Health, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Dikla', 'Initials': 'D', 'LastName': 'Segel-Karpas', 'Affiliation': 'Department of Gerontology, University of Haifa, Haifa, Israel.'}]",Aging & mental health,['10.1080/13607863.2019.1584791']
571,30859218,One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism.,"BACKGROUND


Secondary hyperparathyroidism (sHPT), a common complication of chronic kidney disease, is characterized by elevated serum parathyroid hormone (PTH). Etelcalcetide is an intravenous calcimimetic that increases sensitivity of the calcium-sensing receptor to calcium and decreases PTH secretion. This open-label extension (OLE) trial evaluated the long-term effects of etelcalcetide for sHPT treatment in patients receiving hemodialysis.
METHODS


This 52-week, multicenter, single-arm OLE enrolled patients from three parent trials: two randomized, double-blind, placebo-controlled trials and one open-label, single-arm, 'switch' study from cinacalcet to etelcalcetide. The primary endpoint was to investigate the nature, frequency, severity and relation to treatment of all adverse events (AEs) reported throughout the trial. Secondary endpoints included the proportion of patients with >30% reduction from baseline in PTH and the percentage change from baseline in PTH, albumin-corrected calcium (Ca), phosphate (P) and the calcium-phosphate product (Ca × P).ClinicalTrials.gov identifier: NCT01785875; Amgen study: 20120231.
RESULTS


Overall, 89.8% of the patients experienced one or more treatment-emergent AE. The most common were decreased blood Ca (43.3%), diarrhea (10.8%), vomiting (10.4%) and nausea (9.6%); symptomatic hypocalcemia occurred in 3.7% of the patients. Approximately 68% of patients achieved >30% reduction in PTH, and ∼56% achieved PTH ≤300 pg/mL. Mean percent changes from baseline ranged from -25.4% to -26.1% for PTH, -8.3% to -9.1% for Ca, -3.6% to -4.1% for P and -12.0% to -12.6% for Ca × P.
CONCLUSIONS


Etelcalcetide effectively lowered PTH and its effect was sustained, while no new safety concerns emerged over a 1-year treatment period.",2020,"Approximately 68% of patients achieved >30% reduction in PTH, and ∼56% achieved PTH ≤300 pg/mL. Mean percent changes from baseline ranged from -25.4% to -26.1% for PTH, -8.3% to -9.1% for Ca, -3.6% to -4.1% for P and -12.0% to -12.6% for Ca × P.
","['patients on hemodialysis with secondary hyperparathyroidism', 'patients receiving hemodialysis']","['intravenous etelcalcetide', 'etelcalcetide', 'placebo']","['vomiting', 'proportion of patients with >30% reduction from baseline in PTH and the percentage change from baseline in PTH, albumin-corrected calcium (Ca), phosphate (P) and the calcium-phosphate product', 'symptomatic hypocalcemia', 'blood', 'nature, frequency, severity and relation to treatment of all adverse events (AEs', 'Ca', 'diarrhea', 'nausea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0020503', 'cui_str': 'Hyperparathyroidism, Secondary'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3713906', 'cui_str': 'velcalcetide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C2732404', 'cui_str': 'Corrected measurement of calcium (procedure)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0006711', 'cui_str': 'calcium phosphate'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0005768'}, {'cui': 'C1262865', 'cui_str': 'Natures (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.188422,"Approximately 68% of patients achieved >30% reduction in PTH, and ∼56% achieved PTH ≤300 pg/mL. Mean percent changes from baseline ranged from -25.4% to -26.1% for PTH, -8.3% to -9.1% for Ca, -3.6% to -4.1% for P and -12.0% to -12.6% for Ca × P.
","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Bushinsky', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of Rochester School of Medicine, Rochester, NY, USA.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Department of Medicine, Division of Nephrology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Sunfa', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Clinical Development, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Hongjie', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Biostatistics, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Kopyt', 'Affiliation': 'Department of Medicine, Division of Nephrology, Lehigh Valley Hospital, Allentown, PA, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Martin', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, Saint Louis University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Ureña-Torres', 'Affiliation': 'Department of Nephrology and Dialysis, Ramsay-Générale de Santé, Clinique du Landy, Saint Ouen, France and Necker Hospital, University of Paris Descartes, Paris, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Vervloet', 'Affiliation': 'Department of Nephrology and Amsterdam Cardiovascular Sciences, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'Denver Nephrology, Denver, CO, USA.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz039']
572,30809762,Evaluating the User Performance and Experience with a Re-Engineered 4 mm × 32G Pen Needle: A Randomized Trial with Similar Length/Gauge Needles.,"INTRODUCTION


Since insulin pens were first introduced in 1985, many advances have been made in pen needles (PNs). In this study we evaluated patient-reported outcomes of an investigational newly re-engineered 4 mm × 32G PN, the BD Nano™ 2nd Gen (also known by its ""PRO"" brand extension in many markets outside of the USA). In place of a conventional cylindrical posted hub, the investigational PN's hub is contoured with an expanded surface area. The investigational PN also includes a redesigned inner shield that includes tactile ridges and a remodeled outer cover with improved proportions and attachment grips.
METHODS


This was a multi-site, prospective, open-label, two-period crossover trial. Individuals with type 1 and type 2 diabetes using 32G PNs of ≤ 6 mm in length for ≥ 4 months were eligible. Subjects using     31G PNs of a similar length were eligible after a 2-week wash-in period. Subjects were assigned to one of four groups, with each group using a commercially available PN to which the investigational PN was compared. Each of the two study periods were 15 days: one with the investigational PN and the other with a comparator PN. After completing both study periods, subjects compared experiences between the two PN types. A 150-mm comparative visual analog scale (VAS) was used to evaluate overall preference (primary endpoint) and several secondary endpoints, including overall comfort, injection pain, and ease of use. Data from the four PN groups were combined after poolability was verified. Subgroup analyses were also conducted on each PN group. For VAS responses, a two-sided 95% confidence interval (CI) was calculated for average rating. Threshold for non-inferiority or superiority was established at the lower bound CI of >  - 10 mm or > 0 mm, respectively.
RESULTS


At baseline, average age of subjects was 55.6 years; 51.6% were female; and 85.1% has type 2 diabetes mellitus. Average diabetes duration was 14.2 years, and average duration of injecting was 7.8 years. The investigational PN demonstrated superiority for all outcomes, both primary and secondary, for all groups combined (p < 0.05).
CONCLUSIONS


The investigational PN was rated as being overall preferred, more comfortable, less painful, and easier to use when compared to comparator PNs of similar gauge and length, in all groups combined.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov (NCT03267264).
FUNDING


BD (Becton, Dickinson, and Company).",2019,"The investigational PN demonstrated superiority for all outcomes, both primary and secondary, for all groups combined (p < 0.05).
","['At baseline, average age of subjects was 55.6\xa0years; 51.6% were female; and 85.1% has type 2 diabetes mellitus', 'Individuals with type 1 and type 2 diabetes using 32G PNs of ≤ 6\xa0mm in length for\u2009≥\u20094\xa0months were eligible']","['Re-Engineered 4\xa0mm\u2009×', '32G Pen Needle', 'Similar Length/Gauge Needles']","['overall comfort, injection pain, and ease of use', 'Average diabetes duration']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2711872', 'cui_str': '32G'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0878517', 'cui_str': 'Engineer'}, {'cui': 'C2711872', 'cui_str': '32G'}, {'cui': 'C4319659', 'cui_str': 'Pen (unit of presentation)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.114217,"The investigational PN demonstrated superiority for all outcomes, both primary and secondary, for all groups combined (p < 0.05).
","[{'ForeName': 'Shahista', 'Initials': 'S', 'LastName': 'Whooley', 'Affiliation': 'BD (Becton, Dickinson and Company), Andover, MA\xa0, USA. shahista.whooley@bd.com.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Briskin', 'Affiliation': 'Rapid Medical Research, Cleveland, OH, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gibney', 'Affiliation': 'BD (Becton, Dickinson and Company), Franklin Lakes, NJ, USA.'}, {'ForeName': 'Lydia R', 'Initials': 'LR', 'LastName': 'Blank', 'Affiliation': 'BD (Becton, Dickinson and Company), Franklin Lakes, NJ, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Berube', 'Affiliation': 'BD (Becton, Dickinson and Company), Franklin Lakes, NJ, USA.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Pflug', 'Affiliation': 'BD (Becton, Dickinson and Company), Franklin Lakes, NJ, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-019-0585-7']
573,32080823,"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alirocumab in Healthy Chinese Subjects: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study.","BACKGROUND


The addition of alirocumab (a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 [PCSK9]) to background statin therapy provides significant incremental low-density lipoprotein cholesterol (LDL-C) lowering and cardiovascular event risk reduction.
OBJECTIVES


Our objectives were to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of alirocumab in healthy Chinese subjects.
METHODS


In this double-blind, placebo-controlled, phase I study, 35 Chinese subjects (aged 21-45 years) with baseline LDL-C > 100 mg/dL (2.59 mmol/L) were randomized to receive a single 1 mL subcutaneous injection of alirocumab 75, 150, or 300 mg, or placebo, and followed up for ~ 12 weeks.
RESULTS


Treatment-emergent adverse events, most frequently nasal congestion and dry throat, were reported in three of seven or eight subjects in each alirocumab dose group (two of seven in the placebo group). One patient receiving alirocumab 300 mg had a mild local injection-site reaction. No alirocumab recipients demonstrated antidrug antibodies. Maximum alirocumab serum concentrations (6-34 mg/dL) occurred at a median of 3-7 days across the dose groups. Maximum mean LDL-C reductions from baseline were observed on days 8, 15, and 22 with alirocumab 75 (55.3%), 150 (63.7%), and 300 mg (73.7%), respectively. Mean free PCSK9 levels were reduced to below the lower limit of quantification within 4 h of dosing. Total cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B were reduced with alirocumab.
CONCLUSIONS


In Chinese subjects, alirocumab 75, 150, and 300 mg was safe and well-tolerated. Pharmacokinetic/pharmacodynamic parameters, including clinically meaningful reductions in LDL-C and other lipids/lipoproteins, were consistent with data from Japanese and Western populations. Clinicaltrials.gov identifier: NCT02979015.",2020,"Total cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B were reduced with alirocumab.
","['healthy Chinese subjects', '35 Chinese subjects (aged 21-45\xa0years) with baseline LDL-C\u2009', 'Healthy Chinese Subjects']","['placebo', 'alirocumab', 'alirocumab 75, 150, or 300\xa0mg, or placebo', 'Placebo']","['Maximum mean LDL-C reductions', 'mild local injection-site reaction', 'Maximum alirocumab serum concentrations', 'Mean free PCSK9 levels', 'nasal congestion and dry throat', 'safety, tolerability, pharmacokinetics, and pharmacodynamics', 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alirocumab', 'antidrug antibodies', 'Total cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B', 'incremental low-density lipoprotein cholesterol (LDL-C) lowering and cardiovascular event risk reduction', 'safe and well-tolerated']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion (finding)'}, {'cui': 'C0235234', 'cui_str': 'Pharyngeal dryness (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C1273410', 'cui_str': 'Cardiovascular event risk'}]",35.0,0.492798,"Total cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B were reduced with alirocumab.
","[{'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Peking University Third Hospital, 49 North Garden Road, Haidian Distrct, Beijing, 100191, China. haiyanli1027@hotmail.com.'}, {'ForeName': 'Yudong', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Drug Clinical Trial Center, Peking University Third Hospital, 49 North Garden Road, Haidian Distrct, Beijing, 100191, China.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Drug Clinical Trial Center, Peking University Third Hospital, 49 North Garden Road, Haidian Distrct, Beijing, 100191, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Drug Clinical Trial Center, Peking University Third Hospital, 49 North Garden Road, Haidian Distrct, Beijing, 100191, China.'}, {'ForeName': 'Xiuxiu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Drug Clinical Trial Center, Peking University Third Hospital, 49 North Garden Road, Haidian Distrct, Beijing, 100191, China.'}, {'ForeName': 'Mengmeng', 'Initials': 'M', 'LastName': 'Shuai', 'Affiliation': 'Sanofi, Beijing, China.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Vitse', 'Affiliation': 'Clinical Development R&D, Sanofi, Montpellier, France.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Sanofi, Beijing, China.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Baccara-Dinet', 'Affiliation': 'Clinical Development R&D, Sanofi, Montpellier, France.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Jianyong', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Sanofi R&D, Shanghai, China.'}]","American journal of cardiovascular drugs : drugs, devices, and other interventions",['10.1007/s40256-020-00394-1']
574,30855743,Randomized Trial of Four Treatment Approaches for Actinic Keratosis.,"BACKGROUND


Actinic keratosis is the most frequent premalignant skin disease in the white population. In current guidelines, no clear recommendations are made about which treatment is preferred.
METHODS


We investigated the effectiveness of four frequently used field-directed treatments (for multiple lesions in a continuous area). Patients with a clinical diagnosis of five or more actinic keratosis lesions on the head, involving one continuous area of 25 to 100 cm 2 , were enrolled at four Dutch hospitals. Patients were randomly assigned to treatment with 5% fluorouracil cream, 5% imiquimod cream, methyl aminolevulinate photodynamic therapy (MAL-PDT), or 0.015% ingenol mebutate gel. The primary outcome was the proportion of patients with a reduction of 75% or more in the number of actinic keratosis lesions from baseline to 12 months after the end of treatment. Both a modified intention-to-treat analysis and a per-protocol analysis were performed.
RESULTS


A total of 624 patients were included from November 2014 through March 2017. At 12 months after the end of treatment, the cumulative probability of remaining free from treatment failure was significantly higher among patients who received fluorouracil (74.7%; 95% confidence interval [CI], 66.8 to 81.0) than among those who received imiquimod (53.9%; 95% CI, 45.4 to 61.6), MAL-PDT (37.7%; 95% CI, 30.0 to 45.3), or ingenol mebutate (28.9%; 95% CI, 21.8 to 36.3). As compared with fluorouracil, the hazard ratio for treatment failure was 2.03 (95% CI, 1.36 to 3.04) with imiquimod, 2.73 (95% CI, 1.87 to 3.99) with MAL-PDT, and 3.33 (95% CI, 2.29 to 4.85) with ingenol mebutate (P≤0.001 for all comparisons). No unexpected toxic effects were documented.
CONCLUSIONS


At 12 months after the end of treatment in patients with multiple actinic keratosis lesions on the head, 5% fluorouracil cream was the most effective of four field-directed treatments. (Funded by the Netherlands Organization for Health Research and Development; ClinicalTrials.gov number, NCT02281682.).",2019,"As compared with fluorouracil, the hazard ratio for treatment failure was 2.03 (95% CI, 1.36 to 3.04) with imiquimod, 2.73 (95% CI, 1.87 to 3.99) with MAL-PDT, and 3.33 (95% CI, 2.29 to 4.85) with ingenol mebutate (P≤0.001 for all comparisons).","['Actinic Keratosis', 'patients with multiple actinic keratosis lesions', 'Patients with a clinical diagnosis of five or more actinic keratosis lesions on the head, involving one continuous area of 25 to 100 cm 2 , were enrolled at four Dutch hospitals', '624 patients were included from November 2014 through March 2017']","['fluorouracil cream', 'fluorouracil', 'imiquimod', '5% fluorouracil cream, 5% imiquimod cream, methyl aminolevulinate photodynamic therapy (MAL-PDT), or 0.015% ingenol mebutate gel']","['proportion of patients with a reduction of 75% or more in the number of actinic keratosis lesions', 'MAL-PDT', 'toxic effects', 'hazard ratio for treatment failure', 'cumulative probability of remaining free from treatment failure']","[{'cui': 'C0022602', 'cui_str': 'Senile keratoma (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}, {'cui': 'C1134467', 'cui_str': 'methyl aminolevulinate'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C4517396', 'cui_str': 'Zero point zero one five'}, {'cui': 'C2825682', 'cui_str': 'ingenol mebutate'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0022602', 'cui_str': 'Senile keratoma (disorder)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0162643'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",624.0,0.266103,"As compared with fluorouracil, the hazard ratio for treatment failure was 2.03 (95% CI, 1.36 to 3.04) with imiquimod, 2.73 (95% CI, 1.87 to 3.99) with MAL-PDT, and 3.33 (95% CI, 2.29 to 4.85) with ingenol mebutate (P≤0.001 for all comparisons).","[{'ForeName': 'Maud H E', 'Initials': 'MHE', 'LastName': 'Jansen', 'Affiliation': 'From the Departments of Dermatology (M.H.E.J., J.P.H.M.K., N.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and Clinical Epidemiology and Medical Technology Assessment (B.A.B.E.), Maastricht University Medical Center, and the GROW School for Oncology and Developmental Biology (M.H.E.J., J.P.H.M.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and the Department of Epidemiology (P.J.N.), Maastricht University, Maastricht, the Department of Dermatology, Zuyderland Medical Center, Heerlen (J.P.H.M.K., P.J.F.Q.), the Department of Dermatology, Catharina Hospital, Eindhoven (A.H.M.M.A., P.M.S.), and the Department of Dermatology, VieCuri Medical Center, Venlo (H.P.A.P.) - all in the Netherlands.'}, {'ForeName': 'Janneke P H M', 'Initials': 'JPHM', 'LastName': 'Kessels', 'Affiliation': 'From the Departments of Dermatology (M.H.E.J., J.P.H.M.K., N.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and Clinical Epidemiology and Medical Technology Assessment (B.A.B.E.), Maastricht University Medical Center, and the GROW School for Oncology and Developmental Biology (M.H.E.J., J.P.H.M.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and the Department of Epidemiology (P.J.N.), Maastricht University, Maastricht, the Department of Dermatology, Zuyderland Medical Center, Heerlen (J.P.H.M.K., P.J.F.Q.), the Department of Dermatology, Catharina Hospital, Eindhoven (A.H.M.M.A., P.M.S.), and the Department of Dermatology, VieCuri Medical Center, Venlo (H.P.A.P.) - all in the Netherlands.'}, {'ForeName': 'Patty J', 'Initials': 'PJ', 'LastName': 'Nelemans', 'Affiliation': 'From the Departments of Dermatology (M.H.E.J., J.P.H.M.K., N.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and Clinical Epidemiology and Medical Technology Assessment (B.A.B.E.), Maastricht University Medical Center, and the GROW School for Oncology and Developmental Biology (M.H.E.J., J.P.H.M.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and the Department of Epidemiology (P.J.N.), Maastricht University, Maastricht, the Department of Dermatology, Zuyderland Medical Center, Heerlen (J.P.H.M.K., P.J.F.Q.), the Department of Dermatology, Catharina Hospital, Eindhoven (A.H.M.M.A., P.M.S.), and the Department of Dermatology, VieCuri Medical Center, Venlo (H.P.A.P.) - all in the Netherlands.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Kouloubis', 'Affiliation': 'From the Departments of Dermatology (M.H.E.J., J.P.H.M.K., N.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and Clinical Epidemiology and Medical Technology Assessment (B.A.B.E.), Maastricht University Medical Center, and the GROW School for Oncology and Developmental Biology (M.H.E.J., J.P.H.M.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and the Department of Epidemiology (P.J.N.), Maastricht University, Maastricht, the Department of Dermatology, Zuyderland Medical Center, Heerlen (J.P.H.M.K., P.J.F.Q.), the Department of Dermatology, Catharina Hospital, Eindhoven (A.H.M.M.A., P.M.S.), and the Department of Dermatology, VieCuri Medical Center, Venlo (H.P.A.P.) - all in the Netherlands.'}, {'ForeName': 'Aimee H M M', 'Initials': 'AHMM', 'LastName': 'Arits', 'Affiliation': 'From the Departments of Dermatology (M.H.E.J., J.P.H.M.K., N.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and Clinical Epidemiology and Medical Technology Assessment (B.A.B.E.), Maastricht University Medical Center, and the GROW School for Oncology and Developmental Biology (M.H.E.J., J.P.H.M.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and the Department of Epidemiology (P.J.N.), Maastricht University, Maastricht, the Department of Dermatology, Zuyderland Medical Center, Heerlen (J.P.H.M.K., P.J.F.Q.), the Department of Dermatology, Catharina Hospital, Eindhoven (A.H.M.M.A., P.M.S.), and the Department of Dermatology, VieCuri Medical Center, Venlo (H.P.A.P.) - all in the Netherlands.'}, {'ForeName': 'Han P A', 'Initials': 'HPA', 'LastName': 'van Pelt', 'Affiliation': 'From the Departments of Dermatology (M.H.E.J., J.P.H.M.K., N.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and Clinical Epidemiology and Medical Technology Assessment (B.A.B.E.), Maastricht University Medical Center, and the GROW School for Oncology and Developmental Biology (M.H.E.J., J.P.H.M.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and the Department of Epidemiology (P.J.N.), Maastricht University, Maastricht, the Department of Dermatology, Zuyderland Medical Center, Heerlen (J.P.H.M.K., P.J.F.Q.), the Department of Dermatology, Catharina Hospital, Eindhoven (A.H.M.M.A., P.M.S.), and the Department of Dermatology, VieCuri Medical Center, Venlo (H.P.A.P.) - all in the Netherlands.'}, {'ForeName': 'Patricia J F', 'Initials': 'PJF', 'LastName': 'Quaedvlieg', 'Affiliation': 'From the Departments of Dermatology (M.H.E.J., J.P.H.M.K., N.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and Clinical Epidemiology and Medical Technology Assessment (B.A.B.E.), Maastricht University Medical Center, and the GROW School for Oncology and Developmental Biology (M.H.E.J., J.P.H.M.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and the Department of Epidemiology (P.J.N.), Maastricht University, Maastricht, the Department of Dermatology, Zuyderland Medical Center, Heerlen (J.P.H.M.K., P.J.F.Q.), the Department of Dermatology, Catharina Hospital, Eindhoven (A.H.M.M.A., P.M.S.), and the Department of Dermatology, VieCuri Medical Center, Venlo (H.P.A.P.) - all in the Netherlands.'}, {'ForeName': 'Brigitte A B', 'Initials': 'BAB', 'LastName': 'Essers', 'Affiliation': 'From the Departments of Dermatology (M.H.E.J., J.P.H.M.K., N.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and Clinical Epidemiology and Medical Technology Assessment (B.A.B.E.), Maastricht University Medical Center, and the GROW School for Oncology and Developmental Biology (M.H.E.J., J.P.H.M.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and the Department of Epidemiology (P.J.N.), Maastricht University, Maastricht, the Department of Dermatology, Zuyderland Medical Center, Heerlen (J.P.H.M.K., P.J.F.Q.), the Department of Dermatology, Catharina Hospital, Eindhoven (A.H.M.M.A., P.M.S.), and the Department of Dermatology, VieCuri Medical Center, Venlo (H.P.A.P.) - all in the Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Steijlen', 'Affiliation': 'From the Departments of Dermatology (M.H.E.J., J.P.H.M.K., N.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and Clinical Epidemiology and Medical Technology Assessment (B.A.B.E.), Maastricht University Medical Center, and the GROW School for Oncology and Developmental Biology (M.H.E.J., J.P.H.M.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and the Department of Epidemiology (P.J.N.), Maastricht University, Maastricht, the Department of Dermatology, Zuyderland Medical Center, Heerlen (J.P.H.M.K., P.J.F.Q.), the Department of Dermatology, Catharina Hospital, Eindhoven (A.H.M.M.A., P.M.S.), and the Department of Dermatology, VieCuri Medical Center, Venlo (H.P.A.P.) - all in the Netherlands.'}, {'ForeName': 'Nicole W J', 'Initials': 'NWJ', 'LastName': 'Kelleners-Smeets', 'Affiliation': 'From the Departments of Dermatology (M.H.E.J., J.P.H.M.K., N.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and Clinical Epidemiology and Medical Technology Assessment (B.A.B.E.), Maastricht University Medical Center, and the GROW School for Oncology and Developmental Biology (M.H.E.J., J.P.H.M.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and the Department of Epidemiology (P.J.N.), Maastricht University, Maastricht, the Department of Dermatology, Zuyderland Medical Center, Heerlen (J.P.H.M.K., P.J.F.Q.), the Department of Dermatology, Catharina Hospital, Eindhoven (A.H.M.M.A., P.M.S.), and the Department of Dermatology, VieCuri Medical Center, Venlo (H.P.A.P.) - all in the Netherlands.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Mosterd', 'Affiliation': 'From the Departments of Dermatology (M.H.E.J., J.P.H.M.K., N.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and Clinical Epidemiology and Medical Technology Assessment (B.A.B.E.), Maastricht University Medical Center, and the GROW School for Oncology and Developmental Biology (M.H.E.J., J.P.H.M.K., A.H.M.M.A., P.M.S., N.W.J.K.-S., K.M.) and the Department of Epidemiology (P.J.N.), Maastricht University, Maastricht, the Department of Dermatology, Zuyderland Medical Center, Heerlen (J.P.H.M.K., P.J.F.Q.), the Department of Dermatology, Catharina Hospital, Eindhoven (A.H.M.M.A., P.M.S.), and the Department of Dermatology, VieCuri Medical Center, Venlo (H.P.A.P.) - all in the Netherlands.'}]",The New England journal of medicine,['10.1056/NEJMoa1811850']
575,30786792,A randomized controlled trial comparing the effect of fortification of human milk with an infant formula powder versus unfortified human milk on the growth of preterm very low birth weight infants.,,2020,,['preterm very low birth weight infants'],['fortification of human milk with an infant formula powder versus unfortified human milk'],[],"[{'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}]","[{'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0150589', 'cui_str': 'Baby Formula'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}]",[],,0.0900118,,"[{'ForeName': 'Viraraghavan Vadakkencherry', 'Initials': 'VV', 'LastName': 'Ramaswamy', 'Affiliation': 'Department of Neonatology, Nori Multi-Speciality Hospital, Vijayawada, India.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1580260']
576,30102652,Effect of oral fluconazole 1200 mg/day on QT interval in African adults with HIV-associated cryptococcal meningitis.,": We assessed the effect of fluconazole 1200 mg/day on the QT interval in cryptococcal meningitis patients. Mean corrected QT (QTc) change from baseline to day 7 was 10.1 ms (IQR: -28 to 46 ms) in the fluconazole treatment group and -12.6 ms (IQR: -39 to 13.5 ms) in those not taking fluconazole (P = 0.04). No significant increase in QTc measurements over 500 ms was observed with fluconazole. Nevertheless, it remains important to correct any electrolyte imbalance and avoid concomitant drugs that may increase QTc.",2018,Mean corrected QT (QTc) change from baseline to day 7 was 10.1 ms (IQR: -28 to 46 ms) in the fluconazole treatment group and -12.6 ms (IQR: -39 to 13.5 ms) in those not taking fluconazole (P = 0.04).,"['African adults with HIV-associated cryptococcal meningitis', 'cryptococcal meningitis patients']","['oral fluconazole', 'fluconazole']","['Mean corrected QT (QTc) change', 'QTc measurements']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0085436', 'cui_str': 'Meningitis, Cryptococcal'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",,0.0175403,Mean corrected QT (QTc) change from baseline to day 7 was 10.1 ms (IQR: -28 to 46 ms) in the fluconazole treatment group and -12.6 ms (IQR: -39 to 13.5 ms) in those not taking fluconazole (P = 0.04).,"[{'ForeName': 'Síle F', 'Initials': 'SF', 'LastName': 'Molloy', 'Affiliation': ""Centre for Global Health, Institute for Infection and Immunity, St George's University of London.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bradley', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Karunaharan', 'Affiliation': ""Centre for Global Health, Institute for Infection and Immunity, St George's University of London.""}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Mputu', 'Affiliation': 'University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Stone', 'Affiliation': ""Centre for Global Health, Institute for Infection and Immunity, St George's University of London.""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Phulusa', 'Affiliation': 'University of North Carolina Project-Malawi, Kamuzu Central Hospital, Lilongwe.'}, {'ForeName': 'Chimwemwe', 'Initials': 'C', 'LastName': 'Chawinga', 'Affiliation': 'University of North Carolina Project-Malawi, Kamuzu Central Hospital, Lilongwe.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Gaskell', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, College of Medicine, University of Malawi, Malawi.'}, {'ForeName': 'Dalitso', 'Initials': 'D', 'LastName': 'Segula', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, College of Medicine, University of Malawi, Malawi.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Ming', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, College of Medicine, University of Malawi, Malawi.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Peirse', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, College of Medicine, University of Malawi, Malawi.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Chanda', 'Affiliation': 'University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Shabir', 'Initials': 'S', 'LastName': 'Lakhi', 'Affiliation': 'University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Loyse', 'Affiliation': ""Centre for Global Health, Institute for Infection and Immunity, St George's University of London.""}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Kanyama', 'Affiliation': 'University of North Carolina Project-Malawi, Kamuzu Central Hospital, Lilongwe.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Heyderman', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, College of Medicine, University of Malawi, Malawi.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Harrison', 'Affiliation': ""Centre for Global Health, Institute for Infection and Immunity, St George's University of London.""}]","AIDS (London, England)",['10.1097/QAD.0000000000001961']
577,31696504,The efficacy of a mix of three probiotic strains in reducing abdominal pain and inflammatory biomarkers in acute uncomplicated diverticulitis.,"OBJECTIVE


Acute Uncomplicated Diverticulitis (AUD) is defined as the inflammation of a colon diverticulum, often involving colic wall and pericolic fat. Conventional treatment of AUD includes antibiotics, usually ciprofloxacin and metronidazole, fasting, and fluid therapy. The aim of this study was to test the efficacy of a mix of three probiotic strains (Bifidobacterium lactis LA 304, Lactobacillus salivarius LA 302, Lactobacillus acidophilus LA 201; Lactibiane Iki®, Biocure [PiLeJe Groupe], Italy/PiLeJe Laboratoire, France) in association with conventional antibiotics in treating AUD compared to conventional antibiotics used alone.
PATIENTS AND METHODS


We enrolled 84 (25M/59F mean age 61.5 ± 11.5 years) consecutive patients who came to the Emergency Department of the Fondazione Policlinico Universitario A. Gemelli - IRCCS, Rome, Italy, with a diagnosis of AUD confirmed by CT scan. After routine blood test and dosage of C-reactive protein (C-RP), patients were randomly divided into two groups: Probiotic group (42 patients, 10M/32F mean age 32.23 ± 10.3 years) was treated with ciprofloxacin 400 mg twice a day and metronidazole 500 mg three times a day for one week and simultaneously supplemented with the probiotic mix, 1 sachet twice a day for 10 days. Control group (42 patients, 15M/27F mean age 59.01 ± 11.3 years) received the same antibiotic treatment without the probiotic mix. All patients filled a daily Visual Analog Scale (VAS) for assessment of abdominal pain, with a range value from 0 (asymptomatic) to 10, and CRP value was determined on admission and at discharge.
RESULTS


As regards abdominal pain, on Day 3, Group A showed a significant decrease of 4.06 points (51.4%) in VAS score compared to a decrease of 2.79 points (34.9%) in Group B. On Day 5 the decrease was of 6.3 points (80%) in Group A and of 4.85 points (61%) in Group B. VAS score was reduced by 7.59 points (96%) in Group A and 6.1 points (76%) in Group B on Day 7 +, and by 7.8 points (99%) in Group A and 7.2 points (90%) in Group B on Day 10. About inflammation, Group A showed a decrease in C-RP value of 64%, compared to a decrease of only 35% in Group B. We also observed that the duration of hospitalization was significantly shorter for patients in Group A: 89 h (3.7 days) in Group A vs. 101 h (4.2 days) in Group B (p=0.03).
CONCLUSIONS


Our results indicated showed that the supplement with the probiotic mix of Bifidobacterium lactis LA 304, Lactobacillus salivarius LA 302, and Lactobacillus acidophilus LA 201 in combination with the standard antibiotic therapy for AUD reduced abdominal pain and inflammation significantly more than antibiotic treatment used alone. These findings could be due to the anti-inflammatory activity of the probiotic mix. Larger studies are needed to validate its use in the clinical practice.",2019,"On Day 5 the decrease was of 6.3 points (80%) in Group A and of 4.85 points (61%) in Group B. VAS score was reduced by 7.59 points (96%) in Group A and 6.1 points (76%) in Group B on Day 7 +, and by 7.8 points (99%) in Group A and 7.2 points (90%) in Group B on Day 10.","['Control group (42 patients, 15M/27F mean age 59.01 ± 11.3 years', 'We enrolled 84 (25M/59F mean age 61.5 ± 11.5 years) consecutive patients who came to the Emergency Department of the Fondazione Policlinico Universitario A. Gemelli - IRCCS, Rome, Italy, with a diagnosis of AUD confirmed by CT scan', 'acute uncomplicated diverticulitis', 'group (42 patients, 10M/32F mean age 32.23 ± 10.3 years']","['ciprofloxacin and metronidazole, fasting, and fluid therapy', 'ciprofloxacin 400 mg twice a day and metronidazole', 'antibiotic treatment without the probiotic mix', 'mix of three probiotic strains', 'Probiotic', 'C-reactive protein (C-RP', 'probiotic strains (Bifidobacterium lactis LA 304, Lactobacillus salivarius LA 302, Lactobacillus acidophilus LA 201; Lactibiane Iki®, Biocure [PiLeJe Groupe']","['abdominal pain', 'abdominal pain and inflammation', 'C-RP value', 'daily Visual Analog Scale (VAS', 'abdominal pain and inflammatory biomarkers', 'duration of hospitalization', 'VAS score']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0205115', 'cui_str': 'Afferent (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0012813', 'cui_str': 'Diverticulitis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517519', 'cui_str': 'Ten point three'}]","[{'cui': 'C3871468', 'cui_str': 'ciprofloxacin and metronidazole'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis subsp. lactis'}, {'cui': 'C0317593', 'cui_str': 'Lactobacillus salivarius'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0204159,"On Day 5 the decrease was of 6.3 points (80%) in Group A and of 4.85 points (61%) in Group B. VAS score was reduced by 7.59 points (96%) in Group A and 6.1 points (76%) in Group B on Day 7 +, and by 7.8 points (99%) in Group A and 7.2 points (90%) in Group B on Day 10.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Petruzziello', 'Affiliation': 'Emergency Department, Fondazione Policlinico Universitario A. Gemelli - IRCCS, Rome, Italy. veronica.ojetti@unicatt.it.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Marannino', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Migneco', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Brigida', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Saviano', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Piccioni', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Franceschi', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ojetti', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201910_19316']
578,30744396,Cognitive behaviour therapy for insomnia and depression: qualitative reflections from older adults who participated in a randomised controlled trial.,"Objectives:  To explore the experiences of older adults who participated in a randomised controlled trial (RCT) that tested cognitive behaviour therapy for insomnia and depression. Methods:  Focus groups were conducted post treatment for older adults ( M  age = 75 years; 61% female) who participated in a RCT that tested two experiential interventions targeting comorbid insomnia and depression (cognitive behaviour therapy for insomnia, CBT-I; cognitive behaviour therapy for insomnia plus positive mood strategies, CBT-I+). Six semi-structured focus group interviews ( N  = 31) were analysed using a qualitative thematic analysis. Results:  Interview data were transcribed into 424 sentences and 60 codes were extracted. Thirty-four initial themes emerged, which were transformed into 3 themes and 10 subthemes. The three primary themes were (1) positive experiences, (2) negative experiences, and (3) suggested modifications. The positive subthemes were (1a) therapists, (1b) togetherness, (1c) use of strategies reduced symptoms, and (1d) acceptance. The negative subthemes were (2a) persistent symptoms, (2b) program too condensed, and (2c) attendance obstacles. The suggested modifications were (3a) lengthen program, (3b) multi-dimensional learning, and (3c) multi-modal delivery options. Conclusion:  The experiences and suggestions identified in this study strengthen the foundation to advance therapeutic program development for older adults with comorbid insomnia and depression. Future CBT-I programs for older adults may be improved by increasing the length of therapy (e.g. 8 sessions to 12 sessions), adding multi-dimensional learning opportunities (e.g. visual/audio/mentorship), and offering various modes of treatment delivery (e.g. group, individual, internet, telephone).",2020,"METHODS


Focus groups were conducted post treatment for older adults (M age = 75 years; 61% female) who participated in a RCT that tested two experiential interventions targeting comorbid insomnia and depression (cognitive behaviour therapy for insomnia, CBT-I; cognitive behaviour therapy for insomnia plus positive mood strategies, CBT-I+).","['older adults', 'older adults (M age = 75\u2009years; 61% female) who participated in a', 'older adults with comorbid insomnia and depression', 'older adults who participated']","['RCT that tested two experiential interventions targeting comorbid insomnia and depression (cognitive behaviour therapy for insomnia, CBT-I; cognitive behaviour therapy for insomnia plus positive mood strategies, CBT-I', 'Cognitive behaviour therapy', 'cognitive behaviour therapy']",[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",[],,0.0254088,"METHODS


Focus groups were conducted post treatment for older adults (M age = 75 years; 61% female) who participated in a RCT that tested two experiential interventions targeting comorbid insomnia and depression (cognitive behaviour therapy for insomnia, CBT-I; cognitive behaviour therapy for insomnia plus positive mood strategies, CBT-I+).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sadler', 'Affiliation': 'School of Health and Life Sciences, Federation University Australia, Ballarat, Victoria, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'McLaren', 'Affiliation': 'School of Health and Life Sciences, Federation University Australia, Ballarat, Victoria, Australia.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Klein', 'Affiliation': 'Deputy Vice Chancellor-Research and Innovation Portfolio, Federation University Australia, Ballarat, Victoria, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Jenkins', 'Affiliation': 'School of Health and Life Sciences, Federation University Australia, Ballarat, Victoria, Australia.'}]",Aging & mental health,['10.1080/13607863.2019.1571013']
579,30744491,"Physical, cognitive and psychosocial effects of telerehabilitation-based motor imagery training in people with multiple sclerosis: A randomized controlled pilot trial.","INTRODUCTION


Motor imagery training delivered at home via telerehabilitation is a novel rehabilitation concept. The aim was to investigate the effects of telerehabilitation-based motor imaging training (Tele-MIT) on gait, balance and cognitive and psychosocial outcomes in people with multiple sclerosis (pwMS).
METHODS


This randomized, controlled pilot trial included pwMS and healthy individuals. pwMS were randomly divided into two groups, intervention and control. The intervention group received Tele-MIT twice a week for 8 weeks. The control group was a wait-list group without any additional specific treatment. Healthy participants served as a baseline comparison. The Dynamic Gait Index, used to assess dynamic balance during walking, was the primary outcome. Secondary outcomes included assessments of walking speed, endurance and perceived ability, balance performance assessed by a computerized posturography device, balance confidence, cognitive functions, fatigue, anxiety, depression and quality of life.
RESULTS


Baseline comparisons with healthy individuals revealed that motor imagery abilities were preserved in pwMS ( p  > 0.05). The intervention group exhibited significant improvements in dynamic balance during walking ( p  = 0.002), walking speed ( p  = 0.007), perceived walking ability ( p  = 0.008), balance confidence ( p  = 0.002), most cognitive functions ( p  = 0.001-0.008), fatigue ( p  = 0.001), anxiety ( p  = 0.001), depression ( p  = 0.005) and quality of life ( p  = 0.002). No significant changes were observed in the control group in any of the outcome measures ( p  > 0.05).
DISCUSSION


Tele-MIT is a novel method that proved feasible and effective in improving dynamic balance during walking, walking speed and perceived walking ability, balance confidence, cognitive functions, fatigue, anxiety, depression and quality of life in pwMS.",2020,"The intervention group exhibited significant improvements in dynamic balance during walking ( p = 0.002), walking speed ( p = 0.007), perceived walking ability ( p = 0.008), balance confidence ( p = 0.002), most cognitive functions ( p = 0.001-0.008), fatigue ( p = 0.001), anxiety ( p = 0.001), depression ( p = 0.005) and quality of life ( p = 0.002).","['Healthy participants', 'pwMS and healthy individuals', 'people with multiple sclerosis', 'people with multiple sclerosis (pwMS']","['Tele-MIT', 'telerehabilitation-based motor imagery training', 'telerehabilitation-based motor imaging training (Tele-MIT', 'wait-list group without any additional specific treatment']","['cognitive functions', 'walking speed', 'fatigue', 'dynamic balance during walking, walking speed and perceived walking ability, balance confidence, cognitive functions, fatigue, anxiety, depression and quality of life in pwMS', 'depression', 'gait, balance and cognitive and psychosocial outcomes', 'motor imagery abilities', 'Physical, cognitive and psychosocial effects', 'dynamic balance during walking', 'anxiety', 'Dynamic Gait Index', 'quality of life', 'assessments of walking speed, endurance and perceived ability, balance performance assessed by a computerized posturography device, balance confidence, cognitive functions, fatigue, anxiety, depression and quality of life', 'balance confidence', 'perceived walking ability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C2919794', 'cui_str': 'Dynamic gait index (assessment scale)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}]",,0.0614882,"The intervention group exhibited significant improvements in dynamic balance during walking ( p = 0.002), walking speed ( p = 0.007), perceived walking ability ( p = 0.008), balance confidence ( p = 0.002), most cognitive functions ( p = 0.001-0.008), fatigue ( p = 0.001), anxiety ( p = 0.001), depression ( p = 0.005) and quality of life ( p = 0.002).","[{'ForeName': 'Turhan', 'Initials': 'T', 'LastName': 'Kahraman', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Izmir Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'Savci', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylül University, Izmir, Turkey.'}, {'ForeName': 'Asiye Tuba', 'Initials': 'AT', 'LastName': 'Ozdogar', 'Affiliation': 'Institute of Health Sciences, Dokuz Eylül University, Izmir, Turkey.'}, {'ForeName': 'Zumrut', 'Initials': 'Z', 'LastName': 'Gedik', 'Affiliation': 'Department of Psychology, Izmir Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Egemen', 'Initials': 'E', 'LastName': 'Idiman', 'Affiliation': 'Department of Neurology, Dokuz Eylül University, Izmir, Turkey.'}]",Journal of telemedicine and telecare,['10.1177/1357633X18822355']
580,30511879,Apixaban to Prevent Venous Thromboembolism in Patients with Cancer.,"BACKGROUND


Patients with active cancer have an increased risk of venous thromboembolism, which results in substantial morbidity, mortality, and health care expenditures. The Khorana score (range, 0 to 6, with higher scores indicating a higher risk of venous thromboembolism) has been validated to identify patients with cancer at elevated risk for this complication and may help select those who could benefit from thromboprophylaxis.
METHODS


We conducted a randomized, placebo-controlled, double-blind clinical trial assessing the efficacy and safety of apixaban (2.5 mg twice daily) for thromboprophylaxis in ambulatory patients with cancer who were at intermediate-to-high risk for venous thromboembolism (Khorana score, ≥2) and were initiating chemotherapy. The primary efficacy outcome was objectively documented venous thromboembolism over a follow-up period of 180 days. The main safety outcome was a major bleeding episode.
RESULTS


Of the 574 patients who underwent randomization, 563 were included in the modified intention-to-treat analysis. Venous thromboembolism occurred in 12 of 288 patients (4.2%) in the apixaban group and in 28 of 275 patients (10.2%) in the placebo group (hazard ratio, 0.41; 95% confidence interval [CI], 0.26 to 0.65; P<0.001). In the modified intention-to-treat analysis, major bleeding occurred in 10 patients (3.5%) in the apixaban group and in 5 patients (1.8%) in the placebo group (hazard ratio, 2.00; 95% CI, 1.01 to 3.95; P = 0.046). During the treatment period, major bleeding occurred in 6 patients (2.1%) in the apixaban group and in 3 patients (1.1%) in the placebo group (hazard ratio, 1.89; 95% CI, 0.39 to 9.24).
CONCLUSIONS


Apixaban therapy resulted in a significantly lower rate of venous thromboembolism than did placebo among intermediate-to-high-risk ambulatory patients with cancer who were starting chemotherapy. The rate of major bleeding episodes was higher with apixaban than with placebo. (Funded by the Canadian Institutes of Health Research and Bristol-Myers Squibb-Pfizer Alliance; AVERT ClinicalTrials.gov number, NCT02048865.).",2019,"During the treatment period, major bleeding occurred in 6 patients (2.1%) in the apixaban group and in 3 patients (1.1%) in the placebo group (hazard ratio, 1.89; 95% CI, 0.39 to 9.24).
","['Patients with active cancer', '574 patients who underwent randomization', 'ambulatory patients with cancer who were at intermediate-to-high risk for venous thromboembolism (Khorana score, ≥2) and were initiating chemotherapy', 'Patients with Cancer']","['apixaban', 'Apixaban therapy', 'placebo', 'Apixaban']","['Venous Thromboembolism', 'major bleeding episode', 'Khorana score', 'rate of major bleeding episodes', 'Venous thromboembolism', 'major bleeding', 'rate of venous thromboembolism', 'efficacy and safety', 'venous thromboembolism']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",574.0,0.540304,"During the treatment period, major bleeding occurred in 6 patients (2.1%) in the apixaban group and in 3 patients (1.1%) in the placebo group (hazard ratio, 1.89; 95% CI, 0.39 to 9.24).
","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Abou-Nassar', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Tagalakis', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Sudeep', 'Initials': 'S', 'LastName': 'Shivakumar', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Ariah', 'Initials': 'A', 'LastName': 'Schattner', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Kuruvilla', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Hill', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Spadafora', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Katerine', 'Initials': 'K', 'LastName': 'Marquis', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Mateya', 'Initials': 'M', 'LastName': 'Trinkaus', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tomiak', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Agnes Y Y', 'Initials': 'AYY', 'LastName': 'Lee', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Gross', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lazo-Langner', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'El-Maraghi', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Glenwood', 'Initials': 'G', 'LastName': 'Goss', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Gregoire', 'Initials': 'G', 'LastName': 'Le Gal', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stewart', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Ramsay', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Rodger', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Witham', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Wells', 'Affiliation': ""From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l'Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) - all in Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1814468']
581,29269731,Twelve-month outcomes of a randomized trial of a moderate-carbohydrate versus very low-carbohydrate diet in overweight adults with type 2 diabetes mellitus or prediabetes.,"Dietary treatment is important in management of type 2 diabetes or prediabetes, but uncertainty exists about the optimal diet. We randomized adults (n = 34) with glycated hemoglobin (HbA1c) > 6.0% and elevated body weight (BMI > 25) to a very low-carbohydrate ketogenic (LCK) diet (n = 16) or a moderate-carbohydrate, calorie-restricted, low-fat (MCCR) diet (n = 18). All participants were encouraged to be physically active, get sufficient sleep, and practice behavioral adherence strategies based on positive affect and mindful eating. At 12 months, participants in the LCK group had greater reductions in HbA1c levels (estimated marginal mean (EMM) at baseline = 6.6%, at 12 mos = 6.1%) than participants in MCCR group (EMM at baseline = 6.9%, at 12 mos = 6.7%), p = .007. Participants in the LCK group lost more weight (EMM at baseline = 99.9 kg, at 12 mos = 92.0 kg) than participants in the MCCR group (EMM at baseline = 97.5 kg, at 12 mos = 95.8 kg), p < .001. The LCK participants experienced larger reductions in diabetes-related medication use; of participants who took sulfonylureas or dipeptidyl peptidase-4 inhibitors at baseline, 6/10 in the LCK group discontinued these medications compared with 0/6 in the MCCR group (p = .005). In a 12-month trial, adults with elevated HbA1c and body weight assigned to an LCK diet had greater reductions in HbA1c, lost more weight, and reduced more medications than those instructed to follow an MCCR diet.",2017,"Participants in the LCK group lost more weight (EMM at baseline = 99.9 kg, at 12 mos = 92.0 kg) than participants in the MCCR group (EMM at baseline = 97.5 kg, at 12 mos = 95.8 kg), p < .001.","['adults (n\u2009=\u200934) with glycated hemoglobin (HbA1c)\u2009>\u20096.0% and elevated body weight (BMI\u2009>\u200925) to a very', 'adults with elevated HbA1c and body weight assigned to an', 'overweight adults with type 2 diabetes mellitus or prediabetes']","['low-carbohydrate ketogenic (LCK) diet (n\u2009=\u200916) or a moderate-carbohydrate, calorie-restricted, low-fat (MCCR) diet', 'moderate-carbohydrate versus very low-carbohydrate diet', 'LCK', 'LCK diet']","['weight (EMM', 'HbA1c levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic Diet'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0301577', 'cui_str': 'Carbohydrate diet (finding)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",34.0,0.0460536,"Participants in the LCK group lost more weight (EMM at baseline = 99.9 kg, at 12 mos = 92.0 kg) than participants in the MCCR group (EMM at baseline = 97.5 kg, at 12 mos = 95.8 kg), p < .001.","[{'ForeName': 'Laura R', 'Initials': 'LR', 'LastName': 'Saslow', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA. saslowl@umich.edu.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Daubenmier', 'Affiliation': 'San Francisco State University, San Francisco, CA, USA.'}, {'ForeName': 'Judith T', 'Initials': 'JT', 'LastName': 'Moskowitz', 'Affiliation': 'Northwestern University, Evanston, IL, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Murphy', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Phinney', 'Affiliation': 'Virta Health, San Francisco, CA, 94105, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ploutz-Snyder', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Goldman', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Cox', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland, Oakland, CA, USA.""}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Mason', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Moran', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Hecht', 'Affiliation': 'University of California, San Francisco, CA, USA.'}]",Nutrition & diabetes,['10.1038/s41387-017-0006-9']
582,30475762,Maintain Your Brain: Protocol of a 3-Year Randomized Controlled Trial of a Personalized Multi-Modal Digital Health Intervention to Prevent Cognitive Decline Among Community Dwelling 55 to 77 Year Olds.,"BACKGROUND


Maintain Your Brain (MYB) is a randomized controlled trial of an online multi-modal lifestyle intervention targeting modifiable dementia risk factors with its primary aim being to reduce cognitive decline in an older age cohort.
METHODS


MYB aims to recruit 8,500 non-demented community dwelling 55 to 77 year olds from the Sax Institute's 45 and Up Study in New South Wales, Australia. Participants will be screened for risk factors related to four modules that comprise the MYB intervention: physical activity, nutrition, mental health, and cognitive training. Targeting risk factors will enable interventions to be personalized so that participants receive the most appropriate modules. MYB will run for three years and up to four modules will be delivered sequentially each quarter during year one. Upon completing a module, participants will continue to receive less frequent booster activities for their eligible modules (except for the mental health module) until the end of the trial.
DISCUSSION


MYB will be the largest internet-based trial to attempt to prevent cognitive decline and potentially dementia. If successful, MYB will provide a model for not just effective intervention among older adults, but an intervention that is scalable for broad use.",2019,"BACKGROUND


Maintain Your Brain (MYB) is a randomized controlled trial of an online multi-modal lifestyle intervention targeting modifiable dementia risk factors with its primary aim being to reduce cognitive decline in an older age cohort.
","['Community Dwelling 55 to 77 Year Olds', 'older age cohort', ""8,500 non-demented community dwelling 55 to 77 year olds from the Sax Institute's 45 and Up Study in New South Wales, Australia"", 'older adults', 'Maintain Your Brain']","['Personalized Multi-Modal Digital Health Intervention', 'online multi-modal lifestyle intervention']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]",[],8500.0,0.135194,"BACKGROUND


Maintain Your Brain (MYB) is a randomized controlled trial of an online multi-modal lifestyle intervention targeting modifiable dementia risk factors with its primary aim being to reduce cognitive decline in an older age cohort.
","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Heffernan', 'Affiliation': 'Centre for Healthy Brain Ageing, University of New South Wales, Australia.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Andrews', 'Affiliation': 'Clinical Research Unit for Anxiety and Depression, School of Psychiatry, University of New South Wales, Australia.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Fiatarone Singh', 'Affiliation': 'Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Valenzuela', 'Affiliation': 'Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Kaarin J', 'Initials': 'KJ', 'LastName': 'Anstey', 'Affiliation': 'School of Psychology, University of New South Wales, Australia.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Maeder', 'Affiliation': 'College of Nursing & Health Sciences, Flinders University, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McNeil', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Jorm', 'Affiliation': 'Centre for Big Data Research in Health, University of New South Wales, Australia.'}, {'ForeName': 'Nicola T', 'Initials': 'NT', 'LastName': 'Lautenschlager', 'Affiliation': 'University of Melbourne, Australia.'}, {'ForeName': 'Perminder S', 'Initials': 'PS', 'LastName': 'Sachdev', 'Affiliation': 'Centre for Healthy Brain Ageing, University of New South Wales, Australia.'}, {'ForeName': 'Jeewani A', 'Initials': 'JA', 'LastName': 'Ginige', 'Affiliation': 'Western Sydney University, Australia.'}, {'ForeName': 'Megan J', 'Initials': 'MJ', 'LastName': 'Hobbs', 'Affiliation': 'Clinical Research Unit for Anxiety and Depression, School of Psychiatry, University of New South Wales, Australia.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Boulamatsis', 'Affiliation': 'Western Sydney University, Australia.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Chau', 'Affiliation': 'Centre for Healthy Brain Ageing, University of New South Wales, Australia.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Cobiac', 'Affiliation': 'CSIRO Health and Biosecurity.'}, {'ForeName': 'Kay L', 'Initials': 'KL', 'LastName': 'Cox', 'Affiliation': 'Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Daniel', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences, University of Sydney, Australia.'}, {'ForeName': 'Victoria M', 'Initials': 'VM', 'LastName': 'Flood', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Australia.'}, {'ForeName': 'Yareni', 'Initials': 'Y', 'LastName': 'Guerrero', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences, University of Sydney, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Gunn', 'Affiliation': 'Department of General Practice, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences, University of Sydney, Australia.'}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Kochan', 'Affiliation': 'Centre for Healthy Brain Ageing, University of New South Wales, Australia.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Lampit', 'Affiliation': 'Brain and Mind Centre, University of Sydney, Australia.'}, {'ForeName': 'Yorgi', 'Initials': 'Y', 'LastName': 'Mavros', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences, University of Sydney, Australia.'}, {'ForeName': 'Jacinda', 'Initials': 'J', 'LastName': 'Meiklejohn', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences, University of Sydney, Australia.'}, {'ForeName': 'Yian', 'Initials': 'Y', 'LastName': 'Noble', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences, University of Sydney, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': ""O'Leary"", 'Affiliation': 'Nutrition and Dietetics Group, School of Life and Environmental Science, Faculty of Science & The Charles Perkins Centre, University of Sydney, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Radd-Vagenas', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences, University of Sydney, Australia.'}, {'ForeName': 'Courtney C', 'Initials': 'CC', 'LastName': 'Walton', 'Affiliation': 'Brain and Mind Centre, University of Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Brodaty', 'Affiliation': 'Centre for Healthy Brain Ageing, University of New South Wales, Australia.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-180572']
583,31691605,Efficacy of Repeat AbobotulinumtoxinA (Dysport®) Injections in Improving Gait in Children with Spastic Cerebral Palsy.,"Purpose : This secondary analysis of a randomized, double-blind study plus open-label extension (NCT01249417/NCT01251380) evaluated the efficacy of abobotulinumtoxinA versus placebo in improving gait pattern in children with dynamic equinus due to cerebral palsy (CP) as assessed by the observational gait scale (OGS).  Methods : Ambulatory children with CP (N = 241, aged 2-17) and dynamic equinus were randomized to treatment with abobotulinumtoxinA (10 or 15U/kg/leg) or placebo injected into the gastrocsoleus. All children received abobotulinumtoxinA in the open-label phase.  Results : In the double-blind phase, abobotulinumtoxinA significantly improved OGS total scores versus placebo at Week 4 (treatment effect vs. placebo: 10U/kg/leg: 1.5 [0.7, 2.3],  p  = .0003; 15U/kg/leg: 1.1 [0.3, 1.9],  p  = .01). In the open-label phase, treatment with abobotulinumtoxinA continued to improve the OGS score at the same magnitude as seen in the double-blind study.  Conclusion : Repeat treatment with abobotulinumtoxinA improved gait in children with dynamic equinus.",2020,"In the double-blind phase, abobotulinumtoxinA significantly improved OGS total scores versus placebo at Week 4 (treatment effect vs. placebo: 10U/kg/leg: 1.5 [0.7, 2.3],  p  = .0003; 15U/kg/leg: 1.1 [0.3, 1.9],  p  = .01).","['Children with Spastic Cerebral Palsy', 'children with dynamic equinus due to cerebral palsy (CP', 'Methods : Ambulatory children with CP', 'N\xa0=\xa0241, aged 2-17) and dynamic equinus', 'children with dynamic equinus']","['abobotulinumtoxinA', 'abobotulinumtoxinA versus placebo', 'placebo', 'Repeat AbobotulinumtoxinA (Dysport®', 'plus open-label extension (NCT01249417/NCT01251380']","['OGS score', 'OGS total scores', 'gait pattern']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy (disorder)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C2719424', 'cui_str': 'abobotulinumtoxinA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0591427', 'cui_str': 'Dysport'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",,0.247343,"In the double-blind phase, abobotulinumtoxinA significantly improved OGS total scores versus placebo at Week 4 (treatment effect vs. placebo: 10U/kg/leg: 1.5 [0.7, 2.3],  p  = .0003; 15U/kg/leg: 1.1 [0.3, 1.9],  p  = .01).","[{'ForeName': 'Nigar', 'Initials': 'N', 'LastName': 'Dursun', 'Affiliation': 'Kocaeli University , Kocaeli, Turkey.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Bonikowski', 'Affiliation': 'Mazovian Neuropsychiatry Center , Zagórze, Warsaw, Poland.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Dabrowski', 'Affiliation': 'Oakland University School of Medicine , Grosse Pointe, MI, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Matthews', 'Affiliation': ""Children's Hospital Colorado , Aurora, CO, USA.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gormley', 'Affiliation': ""Gillette Children's Speciality Healthcare , St Paul, MN, USA.""}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Tilton', 'Affiliation': ""LSUHSC and Children's Hospital New Orleans , New Orleans, LA, USA.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Carranza', 'Affiliation': 'Hospital San José Celaya , Celaya, Mexico.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Grandoulier', 'Affiliation': 'Ipsen Pharma , Les Ulis, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Picaut', 'Affiliation': 'Ipsen , Cambridge, MA, USA.'}, {'ForeName': 'Mauricio R', 'Initials': 'MR', 'LastName': 'Delgado', 'Affiliation': 'University of Texas Southwestern Medical Center and Texas Scottish Rite Hospital for Children , Dallas, TX, USA.'}]",Developmental neurorehabilitation,['10.1080/17518423.2019.1687602']
584,30720503,"Proving the Effectiveness of the Fundamentals of Robotic Surgery (FRS) Skills Curriculum: A Single-blinded, Multispecialty, Multi-institutional Randomized Control Trial.","MINI: Question: Is the Fundamentals of Robotic Surgery (FRS) proficiency-based progression curriculum effective for teaching basic robotic surgery skills?
FINDINGS


In an international multi-institutional, multispecialty, blinded, randomized control trial, implementation of the FRS skills curriculum using various simulation platforms led to improved performance of surgical trainees on a transfer test compared with controls.Meaning: The FRS is an effective simulation-based course for training to proficiency on basic robotic surgery skills before surgeons apply those skills clinically.
OBJECTIVE


To demonstrate the noninferiority of the fundamentals of robotic surgery (FRS) skills curriculum over current training paradigms and identify an ideal training platform.
SUMMARY BACKGROUND DATA


There is currently no validated, uniformly accepted curriculum for training in robotic surgery skills.
METHODS


Single-blinded parallel-group randomized trial at 12 international American College of Surgeons (ACS) Accredited Education Institutes (AEI). Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016. Benchmarks (proficiency levels) on the 7 FRS Dome tasks were established based on expert performance. Participants were then randomly assigned to 4 training groups: Dome (n = 29), dV-Trainer (n = 30), and DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula. The primary outcome was participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test). Secondary outcomes included cognitive test scores, GEARS ratings, and robot familiarity checklist scores.
RESULTS


All groups demonstrated significant performance improvement after skills training (P < 0.01). Participating residents and fellows performed tasks faster (DOME and DVSS groups) and with fewer errors than controls (DOME group; P < 0.01). Inter-rater reliability was high for the checklist scores (0.82-0.97) but moderate for GEARS ratings (0.40-0.67).
CONCLUSIONS


We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test. We therefore argue for its implementation across training programs before surgeons apply these skills clinically.",2019,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"['FRS) Skills Curriculum', 'Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016', '12 international American College of Surgeons (ACS']","['MINI', 'Robotic Surgery', 'robotic surgery (FRS) skills curriculum', 'DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula', 'FRS', 'dV-Trainer']","['GEARS ratings', 'cognitive test scores, GEARS ratings, and robot familiarity checklist scores', 'participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test']","[{'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0010478', 'cui_str': 'Curriculum'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0005595', 'cui_str': 'Aves'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]",,0.168174,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Satava', 'Affiliation': 'Department of Surgery, University of Washington Medical Center, Seattle, WA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Stefanidis', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Levy', 'Affiliation': 'Department of Ob/Gyn, Drexel University College of Medicine, Institute of Surgical Excellence, Philadelphia, PA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Florida Hospital Nicholson Center, University of Central Florida College of Medicine, Celebration, FL.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Martin', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Monfared', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Lava R', 'Initials': 'LR', 'LastName': 'Timsina', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Ara Wardkes', 'Initials': 'AW', 'LastName': 'Darzi', 'Affiliation': ""Department of Surgery, St. Mary's Hospital, Imperial College, London, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Moglia', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Brand', 'Affiliation': 'Andersen Simulation Center, Madigan Army Medical Center, Tacoma, WA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Dorin', 'Affiliation': 'Center for Education, Simulation and Innovation, Hartford Hospital, Hartford, CT.'}, {'ForeName': 'Kristoffel R', 'Initials': 'KR', 'LastName': 'Dumon', 'Affiliation': 'Penn Medicine Clinical Simulation Center, Philadelphia, PA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Francone', 'Affiliation': 'Department of Colon and Rectal Surgery, Lahey Health and Medical Center, Burlington, MA.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Georgiou', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Alvin C', 'Initials': 'AC', 'LastName': 'Goh', 'Affiliation': 'Houston Methodist Hospital, Methodist Institute for Technology, Innovation, and Education, Houston, TX.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Marcet', 'Affiliation': 'USF Health Center for Advanced Medical Learning and Simulation, Tampa, FL.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Martino', 'Affiliation': 'Lehigh Valley Health Network, Allentown, PA.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Sudan', 'Affiliation': 'Department of Surgery, Surgical Education and Activities Lab, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Vale', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Gallagher', 'Affiliation': 'Technology Enhanced Learning, ASSERT Centre, College of Medicine and Health, Brookfield Health Sciences Complex, University College Cork, Cork, Ireland.'}]",Annals of surgery,['10.1097/SLA.0000000000003220']
585,31690495,The NEURAPRO Biomarker Analysis: Long-Chain Omega-3 Fatty Acids Improve 6-Month and 12-Month Outcomes in Youths at Ultra-High Risk for Psychosis.,"BACKGROUND


NEURAPRO was a multicenter, placebo-controlled trial of long-chain omega-3 polyunsaturated fatty acids (n-3 PUFAs) (fish oil) in 304 individuals at ultra-high risk for psychotic disorders. The study failed to show benefits of n-3 PUFAs over placebo. Although the randomized controlled trial design is placed at the top of the evidence hierarchy, this methodology has limitations in fish oil randomized controlled trials, as not only is the test agent present in the intervention group, but also n-3 fats are present in the diet and the body tissue of all participants.
METHODS


Analysis of biomarker data (eicosapentaenoic acid [EPA], docosahexaenoic acid [DHA], n-3 index, EPA+DHA) collected as part of NEURAPRO was conducted on 218 participants with longitudinal biomarker data to determine if n-3 PUFAs measured in erythrocytes at baseline and month 6 predicted clinical outcomes.
RESULTS


Increases of the n-3 index, EPA, and DHA predicted less severe psychopathology and better functioning at both follow-up time points. Higher baseline levels and increases of n-3 index also predicted overall clinical improvement at month 6 (n-3 index baseline: adjusted odds ratio [95% confidence interval (CI)] = 1.79 [1.30-2.48]; n-3 PUFA increase: adjusted odds ratio [95% CI] = 1.43 [1.16-1.76]) and at month 12 (n-3 index baseline: adjusted odds ratio [95% CI] = 2.60 [1.71-3.97]; n-3 PUFA increase: adjusted odds ratio [95% CI] = 1.36 [1.06-1.74]).
CONCLUSIONS


These data suggest that n-3 PUFAs can exert therapeutic effects in ultra-high-risk individuals. This finding has implications for early intervention and treatment guidelines, as n-3 PUFA supplementation can easily and safely be used in a wide variety of settings, from primary care to specialist services.",2020,"Higher baseline levels and increases of n-3 index also predicted overall clinical improvement at month 6 (n-3 index baseline: adjusted odds ratio [95% confidence interval (CI)] = 1.79 [1.30-2.48]; n-3 PUFA increase: adjusted odds ratio [95% CI] = 1.43 [1.16-1.76]) and at month 12 (n-3 index baseline: adjusted odds ratio [95% CI] = 2.60 [1.71-3.97]; n-3 PUFA increase: adjusted odds ratio [95% CI] = 1.36 [1.06-1.74]).
","['304 individuals at ultra-high risk for psychotic disorders', '218 participants with longitudinal biomarker data to determine if n-3 PUFAs measured in erythrocytes at baseline and month 6 predicted clinical outcomes', 'Youths at Ultra-High Risk for Psychosis']","['Chain Omega-3 Fatty Acids', 'long-chain omega-3 polyunsaturated fatty acids (n-3 PUFAs) (fish oil', 'placebo', 'n-3 PUFA supplementation', 'n-3 PUFAs', 'n-3 PUFAs over placebo']","['n-3 index, EPA, and DHA predicted less severe psychopathology and better functioning', 'n-3 index']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]","[{'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",304.0,0.330701,"Higher baseline levels and increases of n-3 index also predicted overall clinical improvement at month 6 (n-3 index baseline: adjusted odds ratio [95% confidence interval (CI)] = 1.79 [1.30-2.48]; n-3 PUFA increase: adjusted odds ratio [95% CI] = 1.43 [1.16-1.76]) and at month 12 (n-3 index baseline: adjusted odds ratio [95% CI] = 2.60 [1.71-3.97]; n-3 PUFA increase: adjusted odds ratio [95% CI] = 1.36 [1.06-1.74]).
","[{'ForeName': 'G Paul', 'Initials': 'GP', 'LastName': 'Amminger', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; The Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia. Electronic address: amminger@unimelb.edu.au.'}, {'ForeName': 'Barnaby', 'Initials': 'B', 'LastName': 'Nelson', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; The Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Markulev', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; The Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Hok Pan', 'Initials': 'HP', 'LastName': 'Yuen', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; The Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Miriam R', 'Initials': 'MR', 'LastName': 'Schäfer', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; The Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Maximus', 'Initials': 'M', 'LastName': 'Berger', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; The Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Nilufar', 'Initials': 'N', 'LastName': 'Mossaheb', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Schlögelhofer', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Smesny', 'Affiliation': 'Department of Psychiatry, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Hickie', 'Affiliation': 'Brain and Mind Research Institute, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Gregor E', 'Initials': 'GE', 'LastName': 'Berger', 'Affiliation': 'Child and Adolescent Psychiatric Service of the Canton of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Eric Y H', 'Initials': 'EYH', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Lieuwe', 'Initials': 'L', 'LastName': 'de Haan', 'Affiliation': 'Department of Psychiatry, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Dorien H', 'Initials': 'DH', 'LastName': 'Nieman', 'Affiliation': 'Department of Psychiatry, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Nordentoft', 'Affiliation': 'Psychiatric Centre Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Riecher-Rössler', 'Affiliation': 'University Psychiatric Clinics Basel, Basel, Switzerland.'}, {'ForeName': 'Swapna', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Institute of Mental Health, Singapore.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; The Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Alison Ruth', 'Initials': 'AR', 'LastName': 'Yung', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; The Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; Institute of Brain, Behaviour, and Mental Health, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'McGorry', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; The Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia.'}]",Biological psychiatry,['10.1016/j.biopsych.2019.08.030']
586,30024798,Comprehensive Diabetes Self-Management Support From Food Banks: A Randomized Controlled Trial.,"OBJECTIVES


To determine whether food bank provision of self-management support and diabetes-appropriate food improves glycemic control among clients with diabetes.
METHODS


We screened 5329 adults for diabetes at food pantries (n = 27) affiliated with food banks in Oakland, California; Detroit, Michigan; and Houston, Texas, between October 2015 and September 2016. We individually randomized 568 participants with hemoglobin A1c (HbA1c) 7.5% or greater to waitlist control or 6-month intervention including food, diabetes education, health care referral, and glucose monitoring. The primary outcome was HbA1c at 6 months.
RESULTS


Food security (relative risk [RR] = 0.85; 95% confidence interval [CI] = 0.73, 0.98), food stability (RR = 0.77; 95% CI = 0.64, 0.93), and fruit and vegetable intake (risk difference [RD] = 0.34; 95% CI = 0.34, 0.34) significantly improved among intervention participants. There were no differences in self-management (depressive symptoms, diabetes distress, self-care, hypoglycemia, self-efficacy) or HbA1c (RD = 0.24; 95% CI = -0.09, 0.58).
CONCLUSIONS


Food banks are ideally situated to provide diabetes-appropriate food to food-insecure households. Effective strategies for food banks to support improvements in diabetes clinical outcomes require additional study. Public Health Implications. Moving chronic disease support from clinics into communities expands reach into vulnerable populations. However, it is unclear how community interventions should be integrated with clinical care to improve disease outcomes.
TRIAL REGISTRATION NUMBER


NCT02569060.",2018,"There were no differences in self-management (depressive symptoms, diabetes distress, self-care, hypoglycemia, self-efficacy) or HbA1c (RD = 0.24; 95% CI = -0.09, 0.58).
","['568 participants with hemoglobin A1c (HbA1c) 7.5% or greater to', '5329 adults for diabetes at food pantries (n\u2009=\u200927) affiliated with food banks in Oakland, California; Detroit, Michigan; and Houston, Texas, between October 2015 and September 2016', 'clients with diabetes']","['Comprehensive Diabetes Self-Management Support From Food Banks', 'waitlist control or 6-month intervention including food, diabetes education, health care referral, and glucose monitoring']","['HbA1c at 6 months', 'fruit and vegetable intake', 'self-management (depressive symptoms, diabetes distress, self-care, hypoglycemia, self-efficacy) or HbA1c', 'glycemic control', 'food stability']","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0442598', 'cui_str': 'Bank (environment)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0442598', 'cui_str': 'Bank (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}]",568.0,0.154038,"There were no differences in self-management (depressive symptoms, diabetes distress, self-care, hypoglycemia, self-efficacy) or HbA1c (RD = 0.24; 95% CI = -0.09, 0.58).
","[{'ForeName': 'Hilary K', 'Initials': 'HK', 'LastName': 'Seligman', 'Affiliation': 'Hilary K. Seligman and Sophie Rosenmoss are with the Division of General Internal Medicine and Center for Vulnerable Populations, University of California San Francisco. Hilary K. Seligman is also with, and Morgan Smith and Michelle Berger Marshall are with Feeding America. Elaine Waxman is with Urban Institute, Washington, DC.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': 'Hilary K. Seligman and Sophie Rosenmoss are with the Division of General Internal Medicine and Center for Vulnerable Populations, University of California San Francisco. Hilary K. Seligman is also with, and Morgan Smith and Michelle Berger Marshall are with Feeding America. Elaine Waxman is with Urban Institute, Washington, DC.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Rosenmoss', 'Affiliation': 'Hilary K. Seligman and Sophie Rosenmoss are with the Division of General Internal Medicine and Center for Vulnerable Populations, University of California San Francisco. Hilary K. Seligman is also with, and Morgan Smith and Michelle Berger Marshall are with Feeding America. Elaine Waxman is with Urban Institute, Washington, DC.'}, {'ForeName': 'Michelle Berger', 'Initials': 'MB', 'LastName': 'Marshall', 'Affiliation': 'Hilary K. Seligman and Sophie Rosenmoss are with the Division of General Internal Medicine and Center for Vulnerable Populations, University of California San Francisco. Hilary K. Seligman is also with, and Morgan Smith and Michelle Berger Marshall are with Feeding America. Elaine Waxman is with Urban Institute, Washington, DC.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Waxman', 'Affiliation': 'Hilary K. Seligman and Sophie Rosenmoss are with the Division of General Internal Medicine and Center for Vulnerable Populations, University of California San Francisco. Hilary K. Seligman is also with, and Morgan Smith and Michelle Berger Marshall are with Feeding America. Elaine Waxman is with Urban Institute, Washington, DC.'}]",American journal of public health,['10.2105/AJPH.2018.304528']
587,31688930,Five-Day Changes in Biomarkers of Exposure Among Adult Smokers After Completely Switching From Combustible Cigarettes to a Nicotine-Salt Pod System.,"INTRODUCTION


This study examined changes in biomarkers of exposure (BoE) after 5 days of nicotine-salt pod system (NSPS) use, compared with continuation of usual-cigarette smoking and cigarette abstinence, among adult combustible cigarette smokers.
AIMS AND METHODS


A randomized, open-label, parallel-cohort, confinement study of healthy adult smokers, naive to NSPS use, was conducted. Participants (N = 90) were randomized to six cohorts (n = 15 each): exclusive ad libitum use of NSPS (four flavors: Virginia Tobacco, Mint, Mango, Creme), continuation of usual-brand cigarette smoking, or cigarette abstinence. Total nicotine equivalents and BoE (NNN, NNAL, 3-HPMA, MHBMA, S-PMA, HMPMA, CEMA, 1-OHP, and COHb) were measured.
RESULTS


Eight non-nicotine BoEs, measured in urine, were reduced by an aggregate of 85.0% in the pooled NSPS cohort; increased by 14.4% in the cigarette cohort (p < .001 for pooled NSPS vs. cigarette); and reduced by 85.3% in the abstinence cohort (p > .05; 99.6% relative reduction between pooled NSPS vs. abstinence). Similar changes in individual BoEs were also observed (p < .001 for each BoE between pooled NSPS vs. cigarettes; and abstinence vs. pooled NSPS; p > .05 for each BoE between pooled NSPS vs. abstinence). Blood COHb decreased by 71.8% in the pooled NSPS cohort and 69.1% in the abstinence cohort (p > .05) and increased by 13.3% in the cigarette cohort (p < .001). Mean total urine nicotine equivalents increased in the pooled NSPS and cigarette cohorts by 9% and 26%, respectively, and did not significantly differ (p > .05).
CONCLUSION


Complete switching from cigarettes to NSPS produced significant reductions in key non-nicotine BoEs associated with cigarette smoking.
IMPLICATIONS


The results of this study concorded with evidence that complete switching from combustible cigarettes to tobacco and nontobacco-flavored vapor products may reduce exposure to key carcinogens and other toxicants known to be associated with tobacco-related diseases. Future research is needed to assess the long-term health effects of NSPS use. These results should not be interpreted to mean that the use of NSPS is without any risk, particularly for nonusers of tobacco products.",2020,"Mean total urine nicotine equivalents increased in the pooled NSPS and cigarette cohorts by 9% and 26%, respectively, and did not significantly differ (P>0.05).
","['healthy adult smokers, naive to NSPS use was conducted', 'Adult Smokers after Completely Switching from Combustible Cigarettes to a Nicotine-Salt Pod System', 'Participants (N=90) were randomized to 6 cohorts (n=15 each', 'adult combustible cigarette smokers']","['nicotine-salt pod system (NSPS', 'exclusive ad libitum use of NSPS (4 flavors: Virginia Tobacco, Mint, Mango, Creme), continuation of usual brand cigarette smoking, or cigarette abstinence']","['Blood COHb', 'Mean total urine nicotine equivalents', 'individual BoEs', 'Total nicotine equivalents and biomarkers of exposure (NNN, NNAL, 3-HPMA, MHBMA, S-PMA, HMPMA, CEMA, 1-OHP, and COHb']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0452249', 'cui_str': 'Mint - sweet'}, {'cui': 'C0330955', 'cui_str': 'Mangifera indica'}, {'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0005768'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0063186', 'cui_str': 'hydroxypropyl methacrylate'}, {'cui': 'C0048451', 'cui_str': 'p-methoxy-alpha-methylphenethylamine'}]",,0.0160007,"Mean total urine nicotine equivalents increased in the pooled NSPS and cigarette cohorts by 9% and 26%, respectively, and did not significantly differ (P>0.05).
","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Jay', 'Affiliation': 'JUUL Labs, Inc., San Francisco, CA.'}, {'ForeName': 'Erika L', 'Initials': 'EL', 'LastName': 'Pfaunmiller', 'Affiliation': 'Celerion, Inc., Lincoln, NE.'}, {'ForeName': 'Norman J', 'Initials': 'NJ', 'LastName': 'Huang', 'Affiliation': 'JUUL Labs, Inc., San Francisco, CA.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Cohen', 'Affiliation': 'JUUL Labs, Inc., San Francisco, CA.'}, {'ForeName': 'Donald W', 'Initials': 'DW', 'LastName': 'Graff', 'Affiliation': 'JUUL Labs, Inc., San Francisco, CA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz206']
588,30706365,Efficacy of Real-Time Continuous Glucose Monitoring to Improve Effects of a Prescriptive Lifestyle Intervention in Type 2 Diabetes: A Pilot Study.,"INTRODUCTION


Optimising patient adherence to prescribed lifestyle interventions to achieve improved blood glucose control remains a challenge. Combined use of real-time continuous glucose monitoring systems (RT-CGM) may promote improved glycaemic control. This pilot study examines the effects of a prescriptive lifestyle modification programme when combined with RT-CGM on blood glucose control and cardiovascular disease risk markers.
METHODS


Twenty adults (10 men, 10 women) with obesity and type-2 diabetes (T2D) (age 60.55 ± 8.38 years, BMI 34.22 ± 4.67 kg/m 2 ) were randomised to a prescriptive low-carbohydrate diet and lifestyle plan whilst continuously wearing either an RT-CGM or an 'offline-blinded' monitor (control) for 12 weeks. Outcomes were glycaemic control (HbA1c, fasting glucose, glycaemic variability [GV]), diabetes medication (MeS), weight, blood pressure and lipids assessed pre- and post-intervention.
RESULTS


Both groups experienced reductions in body weight (RT-CGM - 7.4 ± 4.5 kg vs. control - 5.5 ± 4.0 kg), HbA1c (- 0.67 ± 0.82% vs. - 0.68 ± 0.74%), fasting blood glucose (- 1.2 ± 1.9 mmol/L vs. - 1.0 ± 2.2 mmol/L), LDL-C (- 0.07 ± 0.34 mmol/L vs. - 0.26 ± 0.42 mmol/L) and triglycerides (- 0.32 ± 0.46 mmol/L vs. - 0.36 ± 0.53 mmol/L); with no differential effect between groups (P ≥ 0.10). At week 12, GV indices were consistently lower by at least sixfold in RT-CGM compared to control (CONGA-1 - 0.27 ± 0.36 mmol/L vs. 0.06 ± 0.19 mmol/L; CONGA-2 - 0.36 ± 0.54 mmol/L vs. 0.05 ± 2.88 mmol/L; CONGA-4 - 0.44 ± 0.67 mmol/L vs. - 0.02 ± 0.42 mmol/L; CONGA-8 - 0.36 ± 0.61 vs. 0.02 ± 0.52 mmol/L; MAGE - 0.69 ± 1.14 vs. - 0.09 ± 0.08 mmol/L, although there was insufficient power to achieve statistical significance (P ≥ 0.11). Overall, there was an approximately 40% greater reduction in blood glucose-lowering medication (MeS) in RT-CGM (- 0.30 ± 0.59) compared to control (0.02 ± 0.23).
CONCLUSION


This study provides preliminary evidence that RT-CGM may be an effective strategy to optimise glucose control whilst following a low-carbohydrate lifestyle programme that targets improved glycaemic control, with minimal professional support.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry identifier, ANZTR: 372898.
FUNDING


Grant funding was received for the delivery of the clinical trial only, by the Diabetes Australia Research Trust (DART).",2019,"Overall, there was an approximately 40% greater reduction in blood glucose-lowering medication (MeS) in RT-CGM (- 0.30 ± 0.59) compared to control (0.02 ± 0.23).
","['Twenty adults (10 men, 10 women) with obesity and type-2 diabetes (T2D) (age 60.55 ± 8.38 years, BMI 34.22 ± 4.67\xa0kg/m 2 ', 'Type 2 Diabetes']","['real-time continuous glucose monitoring systems (RT-CGM', 'prescriptive lifestyle modification programme', 'Real-Time Continuous Glucose Monitoring', ""prescriptive low-carbohydrate diet and lifestyle plan whilst continuously wearing either an RT-CGM or an 'offline-blinded' monitor (control"", 'RT-CGM', 'Prescriptive Lifestyle Intervention']","['blood glucose control and cardiovascular disease risk markers', 'glycaemic control (HbA1c, fasting glucose, glycaemic variability [GV]), diabetes medication (MeS), weight, blood pressure and lipids assessed pre- and post-intervention', 'glycaemic control', 'fasting blood glucose', 'blood glucose-lowering medication (MeS', 'body weight']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",20.0,0.0203725,"Overall, there was an approximately 40% greater reduction in blood glucose-lowering medication (MeS) in RT-CGM (- 0.30 ± 0.59) compared to control (0.02 ± 0.23).
","[{'ForeName': 'Penelope J', 'Initials': 'PJ', 'LastName': 'Taylor', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation, Health and Biosecurity, Adelaide, Australia. Pennie.Taylor@csiro.au.'}, {'ForeName': 'Campbell H', 'Initials': 'CH', 'LastName': 'Thompson', 'Affiliation': 'Discipline of Medicine, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Luscombe-Marsh', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation, Health and Biosecurity, Adelaide, Australia.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Wycherley', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, School of Health Sciences, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Wittert', 'Affiliation': 'Discipline of Medicine, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Grant D', 'Initials': 'GD', 'LastName': 'Brinkworth', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation, Health and Biosecurity, Sydney, Australia.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-019-0572-z']
589,30691328,Pharmacist-led telehealth disease management program for patients with diabetes and depression.,"INTRODUCTION


The aim of this study was to determine whether a pharmacist-led telehealth disease management program is superior to usual care of nurse-led telehealth in improving diabetes medication adherence, haemoglobin A1C (A1C), and depression scores in patients with concomitant diabetes and depression.
METHODS


Patients with diabetes and depression were randomized to pharmacist-led or nurse-led telehealth. Veterans with type 1 or type 2 diabetes, an A1C ≥ 7.5%, diagnosis of depression, and access to a landline phone were invited to participate. Patients were randomized to usual care of nurse-led telehealth or pharmacist-led telehealth. Patients were shown how to use the telehealth equipment by the nurse or pharmacist. In the pharmacist-led group, the patients received an in-depth medication review in addition to the instruction on the telehealth equipment.
RESULTS


After six months, the pharmacist-led telehealth arm showed significant improvements for cardiovascular medication adherence (14.0; 95% confidence interval (CI) 0.4 to 27.6), antidepressant medication adherence (26.0; 95% CI 0.9 to 51.2), and overall medication adherence combined (13.9; 95% CI 6.6 to 21.2) from baseline to six-month follow-up. There was a significant difference in A1C between each group at the six-month follow-up in the nurse-led telehealth group (6.9 ± 0.9) as compared to the pharmacist-led telehealth group (8.8 ± 2.0). There was no significance in the change in patient health questionnaire-9 (PHQ-9) and Center for Epidemiologic Studies Depression Scale (CES-D) from baseline to follow-up in both groups.
DISCUSSION


Pharmacist-led telehealth was efficacious in improving medication adherence for cardiovascular, antidepressants, and overall medications over a six-month period as compared to nurse-led telehealth. There was no significant improvement in overall depression scores.",2020,There was no significance in the change in patient health questionnaire-9,"['patients with concomitant diabetes and depression', 'patients with diabetes and depression', 'Veterans with type 1 or type 2 diabetes, an A1C\u2009≥\u20097.5%, diagnosis of depression, and access to a landline phone were invited to participate', 'Patients with diabetes and depression']","['pharmacist-led or nurse-led telehealth', 'pharmacist-led telehealth disease management program', 'Pharmacist-led telehealth disease management', 'usual care of nurse-led telehealth or pharmacist-led telehealth']","['diabetes medication adherence, haemoglobin A1C (A1C), and depression scores', 'overall medication adherence', 'cardiovascular medication adherence', 'A1C', 'patient health questionnaire-9', 'PHQ-9) and Center for Epidemiologic Studies Depression Scale (CES-D', 'antidepressant medication adherence', 'overall depression scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0376636', 'cui_str': 'Disease Management'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}]",,0.0341936,There was no significance in the change in patient health questionnaire-9,"[{'ForeName': 'Lisa B', 'Initials': 'LB', 'LastName': 'Cohen', 'Affiliation': 'Department of Pharmacy Practice, University of Rhode Island, Kingston, USA.'}, {'ForeName': 'Tracey H', 'Initials': 'TH', 'LastName': 'Taveira', 'Affiliation': 'Department of Pharmacy Practice, University of Rhode Island, Kingston, USA.'}, {'ForeName': 'Wen-Chih', 'Initials': 'WC', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Veterans Administration Medical Center, Providence, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Pirraglia', 'Affiliation': 'Alpert Medical School, Brown University, Providence, USA.'}]",Journal of telemedicine and telecare,['10.1177/1357633X18822575']
590,30138475,"High intensity, circuit-type integrated neuromuscular training alters energy balance and reduces body mass and fat in obese women: A 10-month training-detraining randomized controlled trial.","This randomized controlled trial examined body mass, body composition, energy balance and performance responses of previously sedentary overweight/obese women to a circuit-type integrated neuromuscular training program with alternative modalities. Forty-nine healthy overweight or class I obese females (36.4±4.4 yrs) were randomly assigned to either a control (N = 21), training (N = 14) or training-detraining (N = 14) group. In weeks 1-20, the training groups trained three times/week using 10-12 whole-body exercises of progressively increased intensity/volume, organized in timed interval circuit form. In weeks 21-40, the training group continued training whereas the training-detraining group not. Heart rate, perceived exertion, blood lactate, exertion, oxygen consumption and excess post-exercise oxygen consumption were measured for one session/phase/person and exercise energy expenditure was calculated. Energy intake, habitual physical activity, resting metabolic rate, body composition, body mass, strength and maximal oxygen consumption were measured at baseline, mid-intervention and post-intervention. A two-way repeated measures ANOVA was used to determine differences between three time points and three groups. In C, VO2max declined (p<0.013) and body fat (p<0.008), waist (p<0.059) and hip (p<0.012) circumferences increased after 40 weeks compared to baseline. Training reduced body mass (6%, p<0.001), body fat (~5.5%, p<0.001) and increased fat-free mass (1.2-3.4%, p<0.05), strength (27.2%, p<0.001) and endurance (26.8%, p<0.001) after a 10-month implementation period using a metabolic overload of only 5-12 metabolic equivalents of task-hours per week. Training induced a long-term negative energy balance during an exercise and a non-exercise day due to an elevation of resting metabolic rate (6%-10%, p<0.05) and exercise-related energy expenditure. Training had an 8% and 94% attrition and attendance rates, respectively. Training-induced gains were attenuated but not lost following a 5-month detraining. A 10-month implementation of a high-intensity interval type training program elicited both endurance and musculoskeletal gains and resulted in a long-term negative energy balance that induced a progressive and sustained reduction of body and fat mass.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03134781.",2018,"Training reduced body mass (6%, p<0.001), body fat (~5.5%, p<0.001) and increased fat-free mass (1.2-3.4%, p<0.05), strength (27.2%, p<0.001) and endurance (26.8%, p<0.001) after a 10-month implementation period using a metabolic overload of only 5-12 metabolic equivalents of task-hours per week.","['I obese females (36.4±4.4 yrs', 'previously sedentary overweight/obese women to a', 'obese women', 'Forty-nine healthy overweight or class']","['training-detraining', 'circuit-type integrated neuromuscular training program with alternative modalities', 'High intensity, circuit-type integrated neuromuscular training']","['VO2max declined (p<0.013) and body fat (p<0.008), waist (p<0.059) and hip (p<0.012) circumferences', 'fat-free mass', 'strength', 'Heart rate, perceived exertion, blood lactate, exertion, oxygen consumption and excess post-exercise oxygen consumption', 'body mass', 'body fat', 'Energy intake, habitual physical activity, resting metabolic rate, body composition, body mass, strength and maximal oxygen consumption']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}]",49.0,0.0768434,"Training reduced body mass (6%, p<0.001), body fat (~5.5%, p<0.001) and increased fat-free mass (1.2-3.4%, p<0.05), strength (27.2%, p<0.001) and endurance (26.8%, p<0.001) after a 10-month implementation period using a metabolic overload of only 5-12 metabolic equivalents of task-hours per week.","[{'ForeName': 'Alexios', 'Initials': 'A', 'LastName': 'Batrakoulis', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Karies, Trikala, Greece.'}, {'ForeName': 'Athanasios Z', 'Initials': 'AZ', 'LastName': 'Jamurtas', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Karies, Trikala, Greece.'}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Georgakouli', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Karies, Trikala, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Draganidis', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Karies, Trikala, Greece.'}, {'ForeName': 'Chariklia K', 'Initials': 'CK', 'LastName': 'Deli', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Karies, Trikala, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Papanikolaou', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Karies, Trikala, Greece.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Avloniti', 'Affiliation': 'School of Physical Education and Sport Sciences, Democritus University of Thrace, Komotini, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Chatzinikolaou', 'Affiliation': 'School of Physical Education and Sport Sciences, Democritus University of Thrace, Komotini, Greece.'}, {'ForeName': 'Diamanda', 'Initials': 'D', 'LastName': 'Leontsini', 'Affiliation': 'School of Physical Education and Sport Sciences, Democritus University of Thrace, Komotini, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Tsimeas', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Karies, Trikala, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Comoutos', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Karies, Trikala, Greece.'}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Bouglas', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Karies, Trikala, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Michalopoulou', 'Affiliation': 'School of Physical Education and Sport Sciences, Democritus University of Thrace, Komotini, Greece.'}, {'ForeName': 'Ioannis G', 'Initials': 'IG', 'LastName': 'Fatouros', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Karies, Trikala, Greece.'}]",PloS one,['10.1371/journal.pone.0202390']
591,31479537,Effect of a multicomponent intervention on achievement and improvements in quality-of-care indices among people with Type 2 diabetes in South Asia: the CARRS trial.,"AIMS


To evaluate whether and what combinations of diabetes quality metrics were achieved in a multicentre trial in South Asia evaluating a multicomponent quality improvement intervention that included non-physician care coordinators to promote adherence and clinical decision-support software to enhance physician practices, in comparision with usual care.
METHODS


Using data from the Centre for Cardiometabolic Risk Reduction in South Asia (CARRS) trial, we evaluated the proportions of trial participants achieving specific and combinations of five diabetes care targets (HbA 1c  <53 mmol/mol [7%], blood pressure <130/80 mmHg, LDL cholesterol <2.6 mmol/L, non-smoking status, and aspirin use). Additionally, we examined the proportions of participants achieving the following risk factor improvements from baseline: ≥11-mmol/mol (1%) reduction in HbA 1c  , ≥10-mmHg reduction in systolic blood pressure, and/or ≥0.26-mmol/l reduction in LDL cholesterol.
RESULTS


Baseline characteristics were similar in the intervention and usual care arms. Overall, 12.3%, 29.4%, 36.5%, 19.5% and 2.2% of participants in the intervention group and 16.2%, 38.3%, 31.6%, 11.3% and 0.8% of participants in the usual care group achieved any one, two, three, four or five targets, respectively. We noted sizeable improvements in HbA 1c  , blood pressure and cholesterol, and found that participants in the intervention group were twice as likely to achieve improvements in all three indices at 12 months that were sustained over 28 months of the study [relative risk 2.1 (95% CI 1.5,2.8) and 1.8 (95% CI 1.5,2.3), respectively].
CONCLUSIONS


The intervention was associated with significantly higher achievement of and greater improvements in composite diabetes quality care goals. However, among these higher-risk participants, very small proportions achieved the complete group of targets, which suggests that achievement of multiple quality-of-care goals is challenging and that other methods may be needed in closing care gaps.",2020,"We noted sizeable improvements in HbA 1c  , blood pressure and cholesterol, and found that participants in the intervention group were twice as likely to achieve improvements in all three indices at 12 months that were sustained over 28 months of the study [relative risk 2.1 (95% CI 1.5,2.8) and 1.8 (95% CI 1.5,2.3), respectively].
","['trial participants achieving specific and combinations of five diabetes care targets (HbA 1c  <53 mmol/mol [7%], blood pressure <130/80 mmHg, LDL cholesterol <2.6 mmol/L, non-smoking status, and aspirin use', 'people with Type 2 diabetes in South Asia', 'Using data from the Centre for Cardiometabolic Risk Reduction in South Asia']",['multicomponent intervention'],"['HbA 1c  , blood pressure and cholesterol', 'risk factor improvements from baseline: ≥11-mmol/mol (1%) reduction in HbA 1c  , ≥10-mmHg reduction in systolic blood pressure, and/or ≥0.26-mmol/l reduction in LDL cholesterol', 'composite diabetes quality care goals', 'quality-of-care indices']","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",[],"[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",53.0,0.0579011,"We noted sizeable improvements in HbA 1c  , blood pressure and cholesterol, and found that participants in the intervention group were twice as likely to achieve improvements in all three indices at 12 months that were sustained over 28 months of the study [relative risk 2.1 (95% CI 1.5,2.8) and 1.8 (95% CI 1.5,2.3), respectively].
","[{'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Shah', 'Affiliation': 'Department of Family and Preventive Medicine, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kondal', 'Affiliation': 'Centre of Excellence, Centre for Cardiometabolic Risk Reduction in South Asia, Public Health Foundation of India, Gurgaon, India.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Patel', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': 'Centre of Excellence, Centre for Cardiometabolic Risk Reduction in South Asia, Public Health Foundation of India, Gurgaon, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Devarajan', 'Affiliation': 'Centre of Excellence, Centre for Cardiometabolic Risk Reduction in South Asia, Public Health Foundation of India, Gurgaon, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Shivashankar', 'Affiliation': 'Centre for Chronic Disease Control India, Public Health Foundation of India, Gurgaon, India.'}, {'ForeName': 'V S', 'Initials': 'VS', 'LastName': 'Ajay', 'Affiliation': 'Centre of Excellence, Centre for Cardiometabolic Risk Reduction in South Asia, Public Health Foundation of India, Gurgaon, India.'}, {'ForeName': 'V U', 'Initials': 'VU', 'LastName': 'Menon', 'Affiliation': 'Department of Endocrinology and Diabetes, Amrita Institute of Medical Sciences, Kerala, India.'}, {'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Varthakavi', 'Affiliation': 'Department of Endocrinology, TNM College and BYL Nair Charity Hospital, Mumbai, India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Viswanathan', 'Affiliation': 'MV Hospital for Diabetes & Diabetes Research Centre, Chennai, India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dharmalingam', 'Affiliation': 'Bangalore Endocrinology and Diabetes Research Centre, Karnataka, India.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bantwal', 'Affiliation': ""Department of Endocrinology, St John's Medical College and Hospital, Karnataka, India.""}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Sahay', 'Affiliation': 'Department of Endocrinology, Osmania General Hospital, Hyderabad, India.'}, {'ForeName': 'M Q', 'Initials': 'MQ', 'LastName': 'Masood', 'Affiliation': 'Department of Medicine, Section of Endocrinology and Diabetes, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Khadgawat', 'Affiliation': 'Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Desai', 'Affiliation': 'Department of Medicine Endocrine Unit, Goa Medical College, Goa, India.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Department of Medicine Endocrine Unit, Goa Medical College, Goa, India.'}, {'ForeName': 'K M V', 'Initials': 'KMV', 'LastName': 'Narayan', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': 'Department of Medicine, Section of Endocrinology and Diabetes, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Ali', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14124']
592,31624297,Vitamin D Supplementation for Premenstrual Syndrome-Related inflammation and antioxidant markers in students with vitamin D deficient: a randomized clinical trial.,"Premenstrual syndrome (PMS) is a common disorder in the reproductive age that negatively significant impacts on women's quality of life. This randomized clinical trial study was undertaken to investigate the effect of vitamin D supplementation on inflammatory and antioxidant markers in 44 vitamin D deficient (25(OH)D < 20 ng/mL) students with PMS. Participants received either 50,000 IU vitamin D3 or a placebo pearl fortnightly for 4 months. At the baseline and in the last 2 months of intervention, participants were asked to complete the PMS Daily Symptoms Rating form along with taking the pearls and their blood samples were collected to assess serum levels of 25(OH)D 3 , Interleukin10 and 12 (IL-10, IL-12) and total antioxidant capacity (TAC). In vitamin D group, serum levels of IL-10 and IL-12 significantly decreased while TAC significantly increased post-intervention. There were significant differences regarding serum IL-12 and TAC levels between the two groups. Mean score of the total PMS symptoms showed significant improvement in 25(OH)D. Vitamin D supplementation seems to be an effective strategy to improve inflammation and antioxidant markers in vitamin D deficient women with PMS. This clinical trial was registered at Iranian Registry of Clinical Trials on 20/06/2018 (IRCT20180525039822N1).",2019,Mean score of the total PMS symptoms showed significant improvement in 25(OH)D. Vitamin D supplementation seems to be an effective strategy to improve inflammation and antioxidant markers in vitamin D deficient women with PMS.,"['vitamin D deficient women with PMS', '44 vitamin D deficient (25(OH)D\u2009<\u200920\u2009ng/mL) students with PMS', 'students with vitamin D deficient']","['vitamin D supplementation', 'vitamin D', '50,000 IU vitamin D3 or a placebo pearl', 'Vitamin D Supplementation']","['serum levels of IL-10 and IL-12', 'inflammatory and antioxidant markers', 'serum IL-12 and TAC levels', 'serum levels of 25(OH)D 3 , Interleukin10 and 12 (IL-10, IL-12) and total antioxidant capacity (TAC', 'inflammation and antioxidant markers', 'PMS Daily Symptoms Rating']","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0429688', 'cui_str': 'Symptom ratings (staging scale)'}]",44.0,0.522755,Mean score of the total PMS symptoms showed significant improvement in 25(OH)D. Vitamin D supplementation seems to be an effective strategy to improve inflammation and antioxidant markers in vitamin D deficient women with PMS.,"[{'ForeName': 'Hajar', 'Initials': 'H', 'LastName': 'Heidari', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Amani', 'Affiliation': 'Professor of Nutrition. Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. r_amani@nutr.mui.ac.ir.'}, {'ForeName': 'Awat', 'Initials': 'A', 'LastName': 'Feizi', 'Affiliation': 'Professor of Biostatistics, Department of Biostatistics and Epidemiology, School of Health, Psychosomatic Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Askari', 'Affiliation': 'Associate Professor of Nutrition, Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Kohan', 'Affiliation': 'Associate Professor of Reproductive Health, Nursing and Midwifery Care Research Center, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Parastoo', 'Initials': 'P', 'LastName': 'Tavasoli', 'Affiliation': 'Molecular Research Lab,, School of Nutrition and Food Sciences, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Scientific reports,['10.1038/s41598-019-51498-x']
593,31680183,Optimal placement of electrodes for treatment of post-stroke dysphagia by neuromuscular electrical stimulation combined with effortful swallowing.,"INTRODUCTION


We aimed to determine the optimal placement of electrodes for neuromuscular electrical stimulation (NMES) for post-stroke dysphagia therapy.
METHODS


31 patients with post-stroke dysphagia were randomised to three groups according to NMES electrode placement. In Group A (n = 10), two pairs of electrodes were attached horizontally on the suprahyoid and infrahyoid muscles. In Group B (n = 11), one pair of electrodes was attached horizontally on the suprahyoid muscles while the other was attached vertically on the infrahyoid muscles. In Group C (n = 10), the electrodes were attached vertically, with one pair above the hyoid bone and the other above the cricoid cartilage. All patients received rehabilitation treatment via NMES combined with effortful swallowing training five times weekly for four weeks. The effect of NMES electrode placement was assessed in terms of the Functional Dysphagia Scale (FDS) and Dysphagia Outcome and Severity Scale (DOSS) scores.
RESULTS


Group A showed significantly greater improvement than Group B in overall FDS (p = 0.009) and pharyngeal-phase FDS (FDS-P; p = 0.005) scores. Group A also showed significant improvement when compared with Group C in overall FDS (p = 0.001) and FDS-P (p = 0.001) scores.
CONCLUSION


Horizontal placement of the NMES electrodes on the suprahyoid and infrahyoid muscles for the treatment of post-stroke dysphagia by NMES combined with effortful swallowing was more effective than the horizontal and vertical placement of electrodes on the suprahyoid and infrahyoid muscles, respectively, and their vertical placement above the hyoid bone and cricoid cartilage.",2020,"Group A also showed significant improvement when compared with Group C in overall FDS (p = 0.001) and FDS-P (p = 0.001) scores.
CONCLUSION


",['31 patients with post-stroke dysphagia'],"['neuromuscular electrical stimulation combined with effortful swallowing', 'rehabilitation treatment via NMES combined with effortful swallowing training', 'NMES electrode placement', 'neuromuscular electrical stimulation (NMES']","['overall FDS', 'Functional Dysphagia Scale (FDS) and Dysphagia Outcome and Severity Scale (DOSS) scores', 'pharyngeal-phase FDS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]","[{'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0011167', 'cui_str': 'Swallowing'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4302242', 'cui_str': 'Functional dysphagia'}, {'cui': 'C0222045'}, {'cui': 'C4707950', 'cui_str': 'Dysphagia Outcome and Severity Scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]",31.0,0.0504669,"Group A also showed significant improvement when compared with Group C in overall FDS (p = 0.001) and FDS-P (p = 0.001) scores.
CONCLUSION


","[{'ForeName': 'Jae-Won', 'Initials': 'JW', 'LastName': 'Huh', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Eunhee', 'Initials': 'E', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Yu-Sun', 'Initials': 'YS', 'LastName': 'Min', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Ae Ryoung', 'Initials': 'AR', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Won-Jong', 'Initials': 'WJ', 'LastName': 'Yang', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Hyun-Min', 'Initials': 'HM', 'LastName': 'Oh', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Tae-Woo', 'Initials': 'TW', 'LastName': 'Nam', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Tae-Du', 'Initials': 'TD', 'LastName': 'Jung', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.'}]",Singapore medical journal,['10.11622/smedj.2019135']
594,32408413,"The effects of elastic band exercises and nutritional education on frailty, strength, and nutritional intake in elderly women.","PURPOSE


The purpose of this study was to examine the effects of elastic band exercises and nutritional education, as well as to identify the factors influencing frailty, strength, and nutritional intake of elderly women.
METHODS


The subjects in this study were 30 elderly women who were divided into four groups. All groups agreed to participate in four programs: health education only (HE), elastic band exercises only (EX), nutritional education only (NU), and elastic band exercises plus nutritional education (EX+NU). Frailty was evaluated by measuring the frailty factors according to Fried et al. Leg strength was measured using a leg-extension machine. Nutritional intake was assessed by the 24-hour recall method and food records. Nutritional intake was analyzed by CAN Pro 5.0 program.
RESULTS


After three months, the prevalence of frailty significantly decreased in the EX+NU group (P=0.013) compared with that of the HE group (P=0.088). There was significant improvement in leg strength in both the EX (P=0.012) and EX+NU groups (P=0.003) compared with that of the HE group (EX, P=0.005; EX+NU, P=0.002). The nutritional intake significantly decreased in the EX group compared with that of the HE group (P<0.05, P<0.05).
CONCLUSION


The combination of elastic exercises and nutrition education had positive effects on frailty and leg strength, while having negative effects on total calories, carbohydrate, sodium, and iron intake in elderly women. Elastic exercises only had positive effects on leg strength while having negative effects on nutritional intake in elderly women.",2020,"There was significant improvement in leg strength in both the EX (P=0.012) and EX+NU groups (P=0.003) compared with that of the HE group (EX, P=0.005; EX+NU, P=0.002).","['30 elderly women who were divided into four groups', 'elderly women']","['EX+NU', 'health education only (HE), elastic band exercises only (EX), nutritional education only (NU), and elastic band exercises plus nutritional education (EX+NU', 'elastic band exercises and nutritional education', 'Elastic exercises', 'elastic exercises and nutrition education']","['Leg strength', 'Nutritional intake', 'leg strength', 'prevalence of frailty', 'nutritional intake', 'frailty and leg strength', 'total calories, carbohydrate, sodium, and iron intake', 'frailty, strength, and nutritional intake']","[{'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0518043', 'cui_str': 'Iron intake'}]",30.0,0.0132178,"There was significant improvement in leg strength in both the EX (P=0.012) and EX+NU groups (P=0.003) compared with that of the HE group (EX, P=0.005; EX+NU, P=0.002).","[{'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Bong', 'Affiliation': ''}, {'ForeName': 'Wook', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': ''}]",Physical activity and nutrition,['10.20463/pan.2020.0007']
595,30489352,The Effect of Acute Glutamine Supplementation on Markers of Inflammation and Fatigue During Consecutive Days of Simulated Wildland Firefighting.,"OBJECTIVE


To examine the effect of oral glutamine supplementation on inflammation and fatigue during and after simulated wildland firefighting (WLFF) tasks in hot conditions over 2 consecutive days.
METHODS


Eleven men and women ingested a glutamine supplement or a placebo before and after simulated wildland firefighting in an environmental chamber (38 °C, 35% relative humidity). Subjective fatigue, markers of inflammation, and cellular stress were measured pre, post and 4 hours post-exercise on both days.
RESULTS


Gastrointestinal damage, subjective fatigue, and ratings of perceived exertion were lower after glutamine supplementation compared with placebo. Heat shock protein 70 (HSP70) and nuclear factor kappa-inhibitor alpha (IκBα) levels were higher on both days of the glutamine trial compared with placebo.
CONCLUSIONS


Glutamine supplementation may improve recovery after fire suppression in WLFFs. This may result from the upregulation of HSP70 which inhibits inflammation and protects against gastrointestinal (GI) barrier damage.",2019,"Heat shock protein 70 (HSP70) and nuclear factor kappa-inhibitor alpha (IκBα) levels were higher on both days of the glutamine trial compared with placebo.
","['Eleven men and women ingested a', 'before and after simulated wildland firefighting in an environmental chamber (38\u200a°C, 35% relative humidity', 'hot conditions over 2 consecutive days']","['Acute Glutamine Supplementation', 'placebo', 'glutamine supplement or a placebo', 'oral glutamine supplementation', 'Glutamine supplementation']","['Heat shock protein 70 (HSP70) and nuclear factor kappa-inhibitor alpha (IκBα) levels', 'Markers of Inflammation and Fatigue', 'Subjective fatigue, markers of inflammation, and cellular stress', 'Gastrointestinal damage, subjective fatigue, and ratings of perceived exertion']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0428696', 'cui_str': 'Relative humidity (observable entity)'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0243043', 'cui_str': 'HSP70 Heat-Shock Proteins'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}]",11.0,0.196751,"Heat shock protein 70 (HSP70) and nuclear factor kappa-inhibitor alpha (IκBα) levels were higher on both days of the glutamine trial compared with placebo.
","[{'ForeName': 'Roberto C', 'Initials': 'RC', 'LastName': 'Nava', 'Affiliation': 'Department of Health, Exercise, and Sport Science, College of Education, Exercise Physiology Lab, Johnson Center B143 MSC04 2610, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Micah N', 'Initials': 'MN', 'LastName': 'Zuhl', 'Affiliation': ''}, {'ForeName': 'Terence A', 'Initials': 'TA', 'LastName': 'Moriarty', 'Affiliation': ''}, {'ForeName': 'Fabiano T', 'Initials': 'FT', 'LastName': 'Amorim', 'Affiliation': ''}, {'ForeName': 'Kelsey C', 'Initials': 'KC', 'LastName': 'Bourbeau', 'Affiliation': ''}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Welch', 'Affiliation': ''}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'McCormick', 'Affiliation': ''}, {'ForeName': 'Kelli E', 'Initials': 'KE', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Mermier', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001507']
596,31688064,"Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study.","OBJECTIVES


To assess the efficacy and safety of vonoprazan on heartburn symptoms in patients with nonerosive reflux disease (NERD) (ClinicalTrials.gov: NCT02954848).
METHODS


This phase 3, double-blind, placebo-controlled study included Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn. Patients received placebo (n = 245) or vonoprazan 10 mg (n = 238) for 4 weeks. The primary efficacy outcome was frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn). Other outcomes included cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution in the fourth week of treatment, and safety.
RESULTS


Compared with placebo, the proportion of days without heartburn was not significantly higher in the vonoprazan group in the full analysis (primary end point, 72.55% vs 61.50%, vonoprazan vs placebo, P = 0.0643) but was significantly higher in the per-protocol-set sensitivity analysis (P = 0.0341). Early onset of response and significantly greater cumulative improvement rates of heartburn were observed in the vonoprazan group (P = 0.0003). In a post hoc analysis, a greater proportion of patients with complete heartburn resolution in the fourth week of treatment were reported in the vonoprazan group (P = 0.0023). Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
DISCUSSION


Although vonoprazan 10 mg was not superior to placebo with respect to proportion of days without heartburn in Japanese patients with NERD, vonoprazan had a significantly higher cumulative rate of heartburn resolution and was well tolerated.",2019,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","['Patients With Nonerosive Gastroesophageal Reflux Disease', 'Japanese patients with NERD', 'patients with nonerosive reflux disease (NERD', 'Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn']","['placebo', 'Placebo', 'Vonoprazan', 'vonoprazan']","['cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution', 'safety', 'tolerated', 'cumulative rate of heartburn resolution', 'Incidence of treatment-emergent adverse events', 'efficacy and safety', 'complete heartburn resolution', 'heartburn symptoms', 'cumulative improvement rates of heartburn', 'proportion of days without heartburn', 'Efficacy and Safety', 'frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}]","[{'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.488409,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan.'}, {'ForeName': 'Yuuichi', 'Initials': 'Y', 'LastName': 'Sakurai', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Takabayashi', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Araki', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Miyagi', 'Affiliation': 'Department of Internal Medicine, Fukuyama Daiichi Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ashida', 'Affiliation': 'Department of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto, Japan.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000101']
597,31619738,The dosing of aerobic exercise therapy on experimentally-induced pain in healthy female participants.,"Knowledge of efficacious dosing respective to exercise type and pain condition is extremely limited in the literature. This study aimed to determine the impact of dose of moderate intensity treadmill walking on experimentally-induced pain in healthy human participants. Forty females were divided into 4 groups: control (no exercise), low dose exercise (3×/wk), moderate dose exercise (5×/wk) or high dose exercise (10×/wk). Over a 7-day period, subjects performed treadmill walking during assigned exercise days. Both qualitative and quantitative measures of pain were measured at baseline, during the trial, and 24 hrs post-final intervention session via sensitivity thresholds to painful thermal and painful pressure stimulation. Significant effects of treatment were found post-intervention for constant pressure pain intensity (p = 0.0016) and pain unpleasantness ratings (p = 0.0014). Post-hoc tests revealed significant differences between control and moderate and control and high dose groups for constant pressure pain intensity (p = 0.0015), (p = 0.0094), respectively and constant pressure pain unpleasantness (p = 0.0040), (p = 0.0040), respectively. Moderate and high dose groups had the greatest reductions in ratings of pain, suggesting that our lowest dose of exercise was not sufficient to reduce pain and that the moderate dose of exercise may be a sufficient starting dose for exercise-based adjuvant pain therapy.",2019,Significant effects of treatment were found post-intervention for constant pressure pain intensity (p = 0.0016) and pain unpleasantness ratings (p = 0.0014).,"['Forty females', 'healthy female participants', 'healthy human participants']","['control (no exercise), low dose exercise (3×/wk), moderate dose exercise (5×/wk) or high dose exercise (10×/wk', 'moderate intensity treadmill walking', 'aerobic exercise therapy']","['ratings of pain', 'pain', 'constant pressure pain unpleasantness', 'constant pressure pain intensity', 'pain unpleasantness ratings']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.0969708,Significant effects of treatment were found post-intervention for constant pressure pain intensity (p = 0.0016) and pain unpleasantness ratings (p = 0.0014).,"[{'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Polaski', 'Affiliation': 'Department of Biological Sciences, Duquesne University, Pittsburgh, Pennsylvania, United States.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Phelps', 'Affiliation': 'Chronic Pain Research Consortium, Duquesne University, Pittsburgh, Pennsylvania, United States.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Szucs', 'Affiliation': 'Chronic Pain Research Consortium, Duquesne University, Pittsburgh, Pennsylvania, United States.'}, {'ForeName': 'Austin M', 'Initials': 'AM', 'LastName': 'Ramsey', 'Affiliation': 'Department of Biological Sciences, Duquesne University, Pittsburgh, Pennsylvania, United States.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Kostek', 'Affiliation': 'Chronic Pain Research Consortium, Duquesne University, Pittsburgh, Pennsylvania, United States.'}, {'ForeName': 'Benedict J', 'Initials': 'BJ', 'LastName': 'Kolber', 'Affiliation': 'Department of Biological Sciences, Duquesne University, Pittsburgh, Pennsylvania, United States. kolberb@duq.edu.'}]",Scientific reports,['10.1038/s41598-019-51247-0']
598,32408412,The effect of short-term creatine intake on blood lactic acid and muscle fatigue measured by accelerometer-based tremor response to acute resistance exercise.,"PURPOSE


The purpose of this study was to investigate the effects of short-term creatine intake on muscle fatigue induced by resistance exercise in healthy adolescent men, i.e., lactic acid concentration and wrist and head tremor measured by an accelerometer.
METHODS


Twelve healthy adolescent men who had no experience with creatine intake were included. The subjects were randomly assigned to the creatine group and the placebo group, followed by 5 days of creatine and placebo intake, and 5 times of 5 sets of leg press, leg extension, bench press, and arm curl exercises at 70% repetition maximum (RM). The lactic acid concentration before and after exercising, rate of perceived exertion (RPE), and accelerometer-based wrist tremor and head tremor during exercise were measured. Subsequently, after 7 days to allow for creatine washout, the same exercise treatment and measurement were performed in each group after switching drug and placebo between the groups.
RESULTS


The level of lactic acid before and after the acute resistance exercise trial was significantly lower in the creatine group than in the placebo group (P <0.05). The mean RPE during the resistance exercise was significantly lower in the creatine group than in the placebo group (P <0.05). There was no difference between the two groups in the mean wrist tremor during resistance exercise, but the mean head tremor values were significantly lower in the creatine group than in the placebo group in the arm curl, the last event of the exercise trials (P <0.05).
CONCLUSION


Short-term creatine intake reduces the blood fatigue factor increased by resistance exercise, and is thought to suppress fatigue, especially in the latter half of resistance exercise. Therefore, these findings indicate that short-term creatine intake can have an improved effect on anaerobic exercise performance.",2020,"There was no difference between the two groups in the mean wrist tremor during resistance exercise, but the mean head tremor values were significantly lower in the creatine group than in the placebo group in the arm curl, the last event of the exercise trials (P <0.05).
","['healthy adolescent men', 'Twelve healthy adolescent men who had no experience with creatine intake were included']","['short-term creatine intake', 'creatine', 'creatine and placebo intake, and 5 times of 5 sets of leg press, leg extension, bench press, and arm curl exercises at 70% repetition maximum (RM', 'placebo']","['mean wrist tremor during resistance exercise', 'rate of perceived exertion (RPE), and accelerometer-based wrist tremor and head tremor during exercise', 'level of lactic acid', 'mean head tremor values', 'mean RPE during the resistance exercise', 'anaerobic exercise performance', 'blood fatigue factor', 'lactic acid concentration', 'blood lactic acid and muscle fatigue', 'lactic acid concentration and wrist and head tremor']","[{'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0239882', 'cui_str': 'Head tremor'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0853170', 'cui_str': 'Blood lactic acid'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}]",12.0,0.0980171,"There was no difference between the two groups in the mean wrist tremor during resistance exercise, but the mean head tremor values were significantly lower in the creatine group than in the placebo group in the arm curl, the last event of the exercise trials (P <0.05).
","[{'ForeName': 'Sinwook', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Gyuseog', 'Initials': 'G', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'Wonil', 'Initials': 'W', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Jaeseong', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Nahyun', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hyejoon', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Jonghoon', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': ''}]",Physical activity and nutrition,['10.20463/pan.2020.0006']
599,30638880,mHealth Improved Fruit and Vegetable Accessibility and Intake in Young Children.,"OBJECTIVE


To explore the potential of mHealth using smartphones to improve fruit and vegetable intake in children.
DESIGN


A 10-week randomized control and intervention pilot study.
SETTING


Story time sessions at local libraries.
PARTICIPANTS


A convenience sample of 30 parents and children (aged 3-8 years).
INTERVENTION


Delivery of nutrition intervention through the mobile Jump2Health website, Facebook posts, and text messages.
MAIN OUTCOME MEASURES


Electronic food photos of children's meals and snacks, 10-question survey related to fruit and vegetable consumption, reflectance spectroscopy via Veggie Meter to measure skin carotenoid levels, body mass index percentiles, and a mobile learning survey.
ANALYSIS


Descriptive statistics and Wilcoxon matched-pairs signed-rank test.
RESULTS


Veggie Meter values for children and parents showed significant week × treatment interactions in the intervention group compared with the control group for both children (P < .001 and parents (P < .001).
CONCLUSIONS AND IMPLICATIONS


This pilot study offers a potentially effective program including a mobile Web site, social media, and test message components to increase fruit and vegetable intake of young children.",2019,"RESULTS


Veggie Meter values for children and parents showed significant week × treatment interactions in the intervention group compared with the control group for both children (P < .001 and parents (P < .001).
","['children', 'young children', 'A convenience sample of 30 parents and children (aged 3-8 years', 'Young Children']","['Delivery of nutrition intervention through the mobile Jump2Health website, Facebook posts, and text messages']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]",[],30.0,0.0527396,"RESULTS


Veggie Meter values for children and parents showed significant week × treatment interactions in the intervention group compared with the control group for both children (P < .001 and parents (P < .001).
","[{'ForeName': 'Ashlee Lane', 'Initials': 'AL', 'LastName': 'Bakırcı-Taylor', 'Affiliation': 'Department of Nutritional Sciences, Texas Tech University, Lubbock, TX. Electronic address: ashleebakircitaylor@gmail.com.'}, {'ForeName': 'Debra B', 'Initials': 'DB', 'LastName': 'Reed', 'Affiliation': 'Department of Nutritional Sciences, Texas Tech University, Lubbock, TX.'}, {'ForeName': 'Barent', 'Initials': 'B', 'LastName': 'McCool', 'Affiliation': 'Department of Restaurant, Hotel, and Institutional Management, Texas Tech University, Lubbock, TX.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Dawson', 'Affiliation': 'Department of Nutritional Sciences, Texas Tech University, Lubbock, TX.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2018.11.008']
600,31677046,The EffectiveNess of LIfestyle with Diet and Physical Activity Education ProGram Among Prehypertensives and Stage 1 HyperTENsives in an Urban Community Setting (ENLIGHTEN) Study.,"This study aims to determine the effectiveness of a monthly lifestyle education program, which included advice on nutritional changes and physical activity enhancement in the reduction of blood pressure and selected biochemical and anthropometric parameters among pre-hypertensive and stage 1 hypertensive participants in Manila, Philippines. Participants resided in two barangays (districts), in Manila, Philippines, and each barangay was assigned to either the intervention or attention-control group. The intervention group received monthly lectures on cardiovascular disease and organized classes on diet and exercise, while the attention-control group received monthly lectures on non-cardiovascular topics, with verbal advice that healthy diet and exercise are important. The primary outcome was systolic blood pressure, with secondary outcomes of BMI, waist circumference, and laboratory measures. Linear mixed effects models with an interaction between intervention group and time were used to estimate the 6-month change in each group. At 6 months, systolic blood pressure was lower in the intervention group compared to the attention-control group (- 12.7 mmHg (95% CI [- 14.5, - 10.9]) vs. - 0.24 mmHg (95% CI [- 1.87, 1.43]), p-value < 0.001). Waist circumference (p < 0.001), BMI (p < 0.001), and total cholesterol (p = 0.049) were also lower. However, no statistically significant difference in fasting glucose was observed between the two groups (p = 0.740). This study showed that participants receiving a non-pharmacological intervention, specifically a low-cost diet and active lifestyle education program, experienced a greater decrease in blood pressure, BMI, waist circumference, and total cholesterol than the attention-control group. Educational programs such as in ENLIGHTEN show promise for a developing country with limited resources to improve hypertension levels, and ultimately cardiovascular health. ENLIGHTEN deserves further study in randomized trials.",2020,"However, no statistically significant difference in fasting glucose was observed between the two groups (p = 0.740).","['pre-hypertensive and stage 1 hypertensive participants in Manila, Philippines', 'Prehypertensives and Stage 1 HyperTENsives in an Urban Community Setting (ENLIGHTEN) Study', 'participants receiving a non-pharmacological intervention, specifically a low-cost diet and active lifestyle education program']","['monthly lectures on cardiovascular disease and organized classes on diet and exercise, while the attention-control group received monthly lectures on non-cardiovascular topics, with verbal advice that healthy diet and exercise', 'LIfestyle with Diet and Physical Activity Education ProGram', 'intervention or attention-control group', 'monthly lifestyle education program']","['blood pressure, BMI, waist circumference, and total cholesterol', 'blood pressure and selected biochemical and anthropometric parameters', 'systolic blood pressure, with secondary outcomes of BMI, waist circumference, and laboratory measures', 'total cholesterol', 'Waist circumference', 'fasting glucose', 'BMI', 'systolic blood pressure']","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",,0.0292947,"However, no statistically significant difference in fasting glucose was observed between the two groups (p = 0.740).","[{'ForeName': 'Julieta', 'Initials': 'J', 'LastName': 'Gabiola', 'Affiliation': 'Division of Primary Care and Population Health, Stanford University School of Medicine, 1265 Welch Road, MC 5475, Stanford, CA, 94305, USA.'}, {'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Morales', 'Affiliation': 'Manila Doctors Hospital, Manila, Philippines.'}, {'ForeName': 'Olive', 'Initials': 'O', 'LastName': 'Quizon', 'Affiliation': 'Manila Doctors Hospital, Manila, Philippines.'}, {'ForeName': 'Ronald Ian', 'Initials': 'RI', 'LastName': 'Cadiz', 'Affiliation': 'Manila Doctors Hospital, Manila, Philippines.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Feliciano', 'Affiliation': 'Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Roberto L', 'Initials': 'RL', 'LastName': 'Ruiz', 'Affiliation': 'Manila Doctors Hospital, Manila, Philippines.'}, {'ForeName': 'Christine Joy', 'Initials': 'CJ', 'LastName': 'Aguatis', 'Affiliation': 'Manila Doctors Hospital, Manila, Philippines.'}, {'ForeName': 'Teresita', 'Initials': 'T', 'LastName': 'Mararac', 'Affiliation': 'Manila Doctors Hospital, Manila, Philippines.'}, {'ForeName': 'Jenssy', 'Initials': 'J', 'LastName': 'Rojina', 'Affiliation': 'Oregon Health and Science University School of Medicine, Portland, OR, USA.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Quantitative Sciences Unit, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Hedlin', 'Affiliation': 'Quantitative Sciences Unit, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cullen', 'Affiliation': 'Center for Population Health Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Latha', 'Initials': 'L', 'LastName': 'Palaniappan', 'Affiliation': 'Division of Primary Care and Population Health, Stanford University School of Medicine, 1265 Welch Road, MC 5475, Stanford, CA, 94305, USA. lathap@stanford.edu.'}]",Journal of community health,['10.1007/s10900-019-00764-0']
601,27966023,"Bismuth adjuvant ameliorates adverse effects of high-dose chemotherapy in patients with multiple myeloma and malignant lymphoma undergoing autologous stem cell transplantation: a randomised, double-blind, prospective pilot study.","PURPOSE


High-dose chemotherapy prior to autologous stem cell transplantation (ASCT) leads to adverse effects including mucositis, neutropenia and bacteremia. To reduce the toxicity, we treated myeloma and lymphoma patients with peroral bismuth as an adjuvant to chemotherapy to convey cytoprotection in non-malignant cells.
METHODS


This trial was a prospective, randomised, double-blind, placebo-controlled pilot study of hematological inpatients (n = 50) receiving bismuth or placebo tablets, in order to identify any potential superiority of bismuth on toxicity from chemotherapy.
RESULTS


We show for the first time that bismuth significantly reduces grade 2 stomatitis, febrile neutropenia and infections caused by melphalan in multiple myeloma, where adverse effects also were significantly linked to gender. In lymphoma patients, bismuth significantly reduces diarrhoea relative to placebo. Also, lymphoma patients' adverse effects were linked to gender. For the first time, bismuth is demonstrated as a safe strategy against chemotherapy's toxicity without interfering with intentional anti-cancer efficiency. Also, we show how gender significantly influences various adverse effects and response to treatment in both multiple myeloma and malignant lymphomas.
CONCLUSION


These results may impact clinical prevention of chemotherapy's cytotoxicity in certain patient groups, and also, this study may direct further attention towards the impact of gender during the course and treatment outcome of malignant disorders.",2017,"In lymphoma patients, bismuth significantly reduces diarrhoea relative to placebo.","['hematological inpatients (n\xa0=\xa050) receiving', 'patients with multiple myeloma and malignant lymphoma undergoing autologous stem cell transplantation']","['bismuth or placebo tablets', 'Bismuth adjuvant', 'placebo', 'autologous stem cell transplantation (ASCT', 'peroral bismuth']","['toxicity', 'mucositis, neutropenia and bacteremia', 'diarrhoea', 'grade 2 stomatitis, febrile neutropenia and infections']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",50.0,0.265311,"In lymphoma patients, bismuth significantly reduces diarrhoea relative to placebo.","[{'ForeName': 'Per Boye', 'Initials': 'PB', 'LastName': 'Hansen', 'Affiliation': 'Department of Hematology, Herlev Hospital, University of Copenhagen, 2720, Herlev, Denmark. pbhn@regionsjaelland.dk.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Penkowa', 'Affiliation': 'Section for Neuroprotection, Hjerneeksperten, 1718, Copenhagen, Denmark.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-016-3522-6']
602,31863245,Hierarchical Poincaré analysis for anaesthesia monitoring.,"Although the degree of dispersion in Poincaré plots of electroencephalograms (EEG), termed the Poincaré-index, detects the depth of anaesthesia, the Poincaré-index becomes estranged from the bispectral index (BIS) at lighter anaesthesia levels. The present study introduces Poincaré-index 20-30 Hz , targeting the 20- to 30-Hz frequency, as the frequency range reported to contain large electromyogram (EMG) portions in frontal EEG. We combined Poincaré-index 20-30 Hz  with the conventional Poincaré-index 0.5-47 Hz  using a deep learning technique to adjust to BIS values, and examined whether this layered Poincaré analysis can provide an index of anaesthesia level like BIS. A total of 83,867 datasets of these two Poincaré-indices and BIS-monitor-derived parameters were continuously obtained every 3 s from 30 patients throughout general anaesthesia, and were randomly divided into 75% for a training dataset and 25% for a test dataset. Two Poincaré-indices and two supplemental EEG parameters (EMG 70-110 Hz , suppression ratio) in the training dataset were trained in a multi-layer perceptron neural network (MLPNN), with reference to BIS as supervisor. We then evaluated the trained MLPNN model using the test dataset, by comparing the measured BIS (mBIS) with BIS predicted from the model (PredBIS). The relationship between mBIS and PredBIS using the two Poincaré-indices showed a tight linear regression equation: mBIS = 1.00 × PredBIS + 0.15, R = 0.87, p < 0.0001, root mean square error (RMSE) = 7.09, while the relationship between mBIS and PredBIS simply using the original Poincaré-index 0.5-47 Hz  was weaker (R = 0.82, p < 0.0001, RMSE = 7.32). This suggests the 20- to 30-Hz hierarchical Poincaré analysis has potential to improve on anaesthesia depth monitoring constructed by simple Poincaré analysis.",2020,"We combined Poincaré-index 20-30 Hz  with the conventional Poincaré-index 0.5-47 Hz  using a deep learning technique to adjust to BIS values, and examined whether this layered Poincaré analysis can provide an index of anaesthesia level like BIS.",['30 patients throughout general anaesthesia'],['combined Poincaré-index 20-30\xa0Hz  with the conventional Poincaré-index 0.5-47\xa0Hz  using a deep learning technique'],['measured BIS (mBIS) with BIS'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4704761', 'cui_str': 'Deep Learning'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}]",,0.0207323,"We combined Poincaré-index 20-30 Hz  with the conventional Poincaré-index 0.5-47 Hz  using a deep learning technique to adjust to BIS values, and examined whether this layered Poincaré analysis can provide an index of anaesthesia level like BIS.","[{'ForeName': 'Kazuma', 'Initials': 'K', 'LastName': 'Hayase', 'Affiliation': 'Department of Anesthesiology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Kazuko', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Department of Anesthesiology, Kyoto Chubu Medical Center, Kyoto, Japan. zukko@koto.kpu-m.ac.jp.'}, {'ForeName': 'Teiji', 'Initials': 'T', 'LastName': 'Sawa', 'Affiliation': 'Department of Anesthesiology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-019-00447-0']
603,31660360,Successful Fecal Microbiota Transplantation in a Patient Suffering From Irritable Bowel Syndrome and Recurrent Urinary Tract Infections.,"Background


Irritable bowel syndrome (IBS) is a chronic and debilitating functional gastrointestinal disorder affecting 9%-23% of the population across the world. The relative efficacy of fecal microbiota transplantation (FMT) on IBS symptoms was demonstrated in a double-blind, randomized study.
Methods


We describe the case of a 73-year-old woman suffering from IBS (abdominal pain, bloating, and abundant and disabling diarrhea, with 10-15 stools a day) and repetitive urinary tract infection (UTI; 5 episodes in 6 months, including 3 the last 2 months) for several years, generating an impaired quality of life. She received an FMT with 400 mL of fecal infusion from a healthy donor via a nasogastric tube after bowel lavage. Her digestive microbiota was analyzed using culturomic and metagenomic targeting 16S rRNA sequencing methods.
Results


Eight months after transplantation, we observed a significant reduction in frequency and improvement in stool consistency (3-4 molded stools a day against 10-15 before the transplant) and no recurrence of urinary infection (as previously reported). Using culturomics, we found 12 bacteria present in the fecal infusion and post-transplant stool; these were absent pretransplant. Three of them ( Intestinimonas massiliensis ,  Oscillibacter massiliensis , and  Provencibacter massiliensis ) were previously discovered and cultivated in our laboratory using culturomics. Using metagenomics, we also observed 12 bacteria, different from those observed during culture, that could have been transferred to the patient by FMT.
Conclusions


In this case report, IBS symptoms and UTI frequency decreased after FMT UTI. Further studies involving more patients would be relevant to confirm this work and develop bacteriotherapy.",2019,"Three of them ( Intestinimonas massiliensis ,  Oscillibacter massiliensis , and  Provencibacter massiliensis ) were previously discovered and cultivated in our laboratory using culturomics.","['73-year-old woman suffering from IBS (abdominal pain, bloating, and abundant and disabling diarrhea, with 10-15 stools a day) and repetitive urinary tract infection (UTI; 5 episodes in 6 months, including 3 the last 2 months) for several years, generating an impaired quality of life']","['FMT with 400 mL of fecal infusion', 'Successful Fecal Microbiota Transplantation', 'fecal microbiota transplantation (FMT']","['IBS symptoms', 'frequency and improvement in stool consistency', 'recurrence of urinary infection', 'IBS symptoms and UTI frequency']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4049260', 'cui_str': 'Impaired quality of life'}]","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C2242628', 'cui_str': 'Fecal Transplantation'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]",12.0,0.0577651,"Three of them ( Intestinimonas massiliensis ,  Oscillibacter massiliensis , and  Provencibacter massiliensis ) were previously discovered and cultivated in our laboratory using culturomics.","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hocquart', 'Affiliation': 'Aix Marseille Univ, IRD, MEPHI, Marseille, France.'}, {'ForeName': 'Thao', 'Initials': 'T', 'LastName': 'Pham', 'Affiliation': 'Aix Marseille Univ, IRD, MEPHI, Marseille, France.'}, {'ForeName': 'Edmond', 'Initials': 'E', 'LastName': 'Kuete', 'Affiliation': 'Aix Marseille Univ, IRD, MEPHI, Marseille, France.'}, {'ForeName': 'Enora', 'Initials': 'E', 'LastName': 'Tomei', 'Affiliation': 'IHU-Méditerranée Infection, Marseille, France.'}, {'ForeName': 'Jean Christophe', 'Initials': 'JC', 'LastName': 'Lagier', 'Affiliation': 'Aix Marseille Univ, IRD, MEPHI, Marseille, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Raoult', 'Affiliation': 'Aix Marseille Univ, IRD, MEPHI, Marseille, France.'}]",Open forum infectious diseases,['10.1093/ofid/ofz398']
604,30535101,Feasibility and potential efficacy of commercial mHealth/eHealth tools for weight loss in African American breast cancer survivors: pilot randomized controlled trial.,"Weight management after breast cancer (BC) treatment in African American (AA) women is crucial to reduce comorbid conditions and health disparities. We examined feasibility and potential efficacy of commercial eHealth/mHealth tools for weight management in AA BC survivors in New Jersey. Participants (N = 35) were randomized to an intervention (SparkPeople) plus activity tracker, Fitbit Charge (n = 18), or wait-list active control group (Fitbit only, n = 17). Anthropometric, behavioral, and quality of life (QOL) outcomes were collected at baseline, 3, 6, and 12 months. Differences in outcomes were assessed using intent-to-treat analysis. Retention was 97.1%. Both groups lost weight, with no significant differences between groups. At month 6, mean weight change was: intervention: -1.71 kg (SD 2.33; p = .006), 33.3% lost ≥3% of baseline weight; control: -2.54 kg (SD 4.00, p = .002), 23.5% lost ≥3% weight. Intervention participants achieved significant improvements in waist circumference (-3.56 cm, SD 4.70, p = .005), QOL (p = .030), and use of strategies for healthy eating (p = .025) and decreasing calories (p < .001). Number of days logged food per week was associated with decreases in waist circumference at 6 months (β -0.79, 95% CI, -1.49, -0.09, p = .030) and 12 months (β -2.16, 95% CI, -4.17, -0.15, p = .038). Weight loss was maintained at 12 months. This is the first study to demonstrate potential efficacy of commercial eHealth/mHealth tools for weight loss in AA BC survivors, without additional counseling from the research team. If effective, they may be convenient weight loss tools that can be easily and widely disseminated. Clinical Trials registration: ClinicalTrials.gov NCT02699983.",2020,"Intervention participants achieved significant improvements in waist circumference (-3.56 cm, SD 4.70, p = .005), QOL (p = .030), and use of strategies for healthy eating (p = .025) and decreasing calories (p < .001).","['AA BC survivors', 'AA BC survivors in New Jersey', 'after breast cancer (BC) treatment in African American (AA) women', 'African American breast cancer survivors', 'Participants (N = 35']","['commercial mHealth/eHealth tools', 'commercial eHealth/mHealth tools', 'Weight management', 'intervention (SparkPeople) plus activity tracker, Fitbit Charge (n = 18), or wait-list active control']","['QOL', 'waist circumference', 'mean weight change', 'weight loss', 'Weight loss', 'healthy eating', 'Anthropometric, behavioral, and quality of life (QOL) outcomes', 'decreasing calories']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0027971', 'cui_str': 'New Jersey'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0034380'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}]",35.0,0.138796,"Intervention participants achieved significant improvements in waist circumference (-3.56 cm, SD 4.70, p = .005), QOL (p = .030), and use of strategies for healthy eating (p = .025) and decreasing calories (p < .001).","[{'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Ferrante', 'Affiliation': 'Department of Family Medicine and Community Health, Rutgers Robert Wood Johnson Medical School, New Brunswick, USA.'}, {'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'Devine', 'Affiliation': 'Cancer Prevention, Control and Population Research, Rutgers Cancer Institute of New Jersey, New Brunswick, USA.'}, {'ForeName': 'Alicja', 'Initials': 'A', 'LastName': 'Bator', 'Affiliation': 'Department of Family Medicine and Community Health, Rutgers Robert Wood Johnson Medical School, New Brunswick, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'Department of Family Medicine and Community Health, Rutgers Robert Wood Johnson Medical School, New Brunswick, USA.'}, {'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Ohman-Strickland', 'Affiliation': 'Cancer Prevention, Control and Population Research, Rutgers Cancer Institute of New Jersey, New Brunswick, USA.'}, {'ForeName': 'Elisa V', 'Initials': 'EV', 'LastName': 'Bandera', 'Affiliation': 'Cancer Prevention, Control and Population Research, Rutgers Cancer Institute of New Jersey, New Brunswick, USA.'}, {'ForeName': 'Kevin O', 'Initials': 'KO', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, University of Texas Health Science Center at Houston, Houston, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby124']
605,30475306,Cardiovascular Risk Factor Reduction in First Responders Resulting From an Individualized Lifestyle and Blood Test Program: A Randomized Controlled Trial.,"OBJECTIVE


We tested the hypothesis that a lifestyle program would improve risk factors linked to cardiovascular disease (CVD) in first responders.
METHODS


A 1-year cluster-randomized controlled clinical trial in 10 cities. Participants were 175 first responders, with increased waist circumference and/or low levels of large (α1) high-density lipoprotein (HDL) particles. The intervention group received personalized online tools and access to telephonic coaching sessions.
RESULTS


At 1 year the intervention significantly reduced body weight (P = 0.004) and waist circumference (P = 0.002), increased α1 HDL (P = 0.01), and decreased triglyceride (P = 0.005) and insulin concentrations (P = 0.03). Program adherence was associated with weight loss (P = 0.0005) and increases in α1 HDL (P = 0.03).
CONCLUSIONS


In first responders, a personalized lifestyle intervention significantly improved CVD risk factors in proportion to program adherence. Changes in large HDL particles were more sensitive indicators of lifestyle changes than HDL-cholesterol measurement.
CLINICAL TRIAL REGISTRATION NUMBER


ClinicalTrials.gov: NCT03322046.",2019,"At 1 year the intervention significantly reduced body weight (P = 0.004) and waist circumference (P = 0.002), increased α1 HDL (P = 0.01), and decreased triglyceride (P = 0.005) and insulin concentrations (P = 0.03).",['10 cities'],"['personalized lifestyle intervention', 'personalized online tools and access to telephonic coaching sessions']","['risk factors linked to cardiovascular disease (CVD', 'Cardiovascular Risk Factor Reduction', 'increased α1 HDL', 'waist circumference', 'weight loss', 'insulin concentrations', 'α1 HDL', 'CVD risk factors', 'waist circumference and/or low levels of large (α1) high-density lipoprotein (HDL) particles', 'triglyceride', 'body weight']","[{'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",10.0,0.11167,"At 1 year the intervention significantly reduced body weight (P = 0.004) and waist circumference (P = 0.002), increased α1 HDL (P = 0.01), and decreased triglyceride (P = 0.005) and insulin concentrations (P = 0.03).","[{'ForeName': 'Rosalynn', 'Initials': 'R', 'LastName': 'Gill', 'Affiliation': ""Boston Heart Diagnostics, Framingham, Massachusetts (Dr Gill, Ms Jones, Ms Ghosh, Mr Gleason, Dr Dansinger); Cholesterol, Genetics, and Heart Disease Institute, Carmel, California (Dr Superko); Heart Fit for Duty, Gilbert, Arizona (Ms McCarthy, Ms Jack); Mesa Fire Services, Mesa, Arizona (Mr Richards); Children's Hospital of Oakland, Oakland (Dr Williams), California; Tufts Medical Center, Boston, Massachusetts (Dr Dansinger).""}, {'ForeName': 'Harold Robert', 'Initials': 'HR', 'LastName': 'Superko', 'Affiliation': ''}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'McCarthy', 'Affiliation': ''}, {'ForeName': 'Kepra', 'Initials': 'K', 'LastName': 'Jack', 'Affiliation': ''}, {'ForeName': 'Briana', 'Initials': 'B', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Debanjali', 'Initials': 'D', 'LastName': 'Ghosh', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Richards', 'Affiliation': ''}, {'ForeName': 'Joi A', 'Initials': 'JA', 'LastName': 'Gleason', 'Affiliation': ''}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dansinger', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001490']
606,31073880,A School-Based Comparison of Positive Search Training to Enhance Adaptive Attention Regulation with a Cognitive-Behavioural Intervention for Reducing Anxiety Symptoms in Children.,"Many children experience anxiety but have limited access to empirically-supported interventions. School-based interventions using brief, computer-assisted training provide a viable way of reaching children. Recent evidence suggests that computer-delivered 'positive search training' (PST) reduces anxiety in children. This multi-informant, randomised controlled trial compared classroom-based, computer-delivered PST (N = 116) to a classroom-based, therapist-delivered cognitive-behavioural intervention (CBI) (N = 127) and a curriculum-as-usual control condition (CAU) (N = 60) in 7-11 year old children. Primary outcomes were child and parent report of child anxiety symptoms. Secondary outcomes were child and parent report of child depressive symptoms and child attention biases. Outcomes were assessed before and after the interventions, and six- and 12-months post-intervention. Teacher report of children's social-emotional functioning was assessed at pre- and post-intervention. As expected, compared to CAU, children receiving PST and the CBI reported greater anxiety reductions by post-intervention and six-month follow-up but, unexpectedly, not at 12-month follow-up. Partially consistent with hypotheses, compared to CAU, parents reported greater anxiety reductions in children receiving PST, but not the CBI, at 12-month follow-up. Contrary to expectation, there was a pre- to post-intervention increase in threat attention bias in PST compared to the other conditions, with no significant differences at follow-up. In support of hypotheses, teachers reported higher post-intervention social-emotional functioning in Year 5 students receiving the CBI but, unexpectedly, lower post-intervention functioning in students receiving PST. There were no effects on depressive symptoms. Further research is needed on strategies to maintain long-term benefits and determine preventative versus early intervention effects.",2019,"In support of hypotheses, teachers reported higher post-intervention social-emotional functioning in Year 5 students receiving the CBI but, unexpectedly, lower post-intervention functioning in students receiving PST.","['children', 'Children']","['classroom-based, computer-delivered PST (N\u2009=\u2009116) to a classroom-based, therapist-delivered cognitive-behavioural intervention (CBI', 'curriculum-as-usual control condition (CAU', ""computer-delivered 'positive search training' (PST"", 'Cognitive-Behavioural Intervention']","['child and parent report of child depressive symptoms and child attention biases', 'child and parent report of child anxiety symptoms', 'depressive symptoms', 'anxiety reductions', 'threat attention bias', ""children's social-emotional functioning""]","[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0259095', 'cui_str': 'C(2)BI'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",,0.109875,"In support of hypotheses, teachers reported higher post-intervention social-emotional functioning in Year 5 students receiving the CBI but, unexpectedly, lower post-intervention functioning in students receiving PST.","[{'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Waters', 'Affiliation': 'School of Applied Psychology, Griffith University, Queensland, 4122, Australia. a.waters@griffith.edu.au.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Candy', 'Affiliation': 'Scandy Statistical Modelling Pty Ltd, Blackmans Bay, Australia.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Zimmer-Gembeck', 'Affiliation': 'School of Applied Psychology, Griffith University, Queensland, 4122, Australia.'}, {'ForeName': 'Trisha A', 'Initials': 'TA', 'LastName': 'Groth', 'Affiliation': 'School of Applied Psychology, Griffith University, Queensland, 4122, Australia.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Brendan P', 'Initials': 'BP', 'LastName': 'Bradley', 'Affiliation': 'Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Mogg', 'Affiliation': 'Psychology, University of Southampton, Southampton, UK.'}]",Journal of abnormal child psychology,['10.1007/s10802-019-00551-4']
607,30015637,Effects of Exercise on Sport Concussion Assessment Tool-Third Edition Performance in Women.,"OBJECTIVE


The purpose of this study was to examine the influence of a brief exercise protocol on Sport Concussion Assessment Tool-Third Edition (SCAT3) performance in amateur women athletes.
DESIGN


Cross-over repeated-measures design.
SETTING


Off-season, uninjured community amateur athletes.
PARTICIPANTS


We examined 87 amateur women athlete volunteers (age = 29.9, SD = 6.9 years).
INDEPENDENT VARIABLES


Participants were assessed using the SCAT3 under 2 conditions: at rest and after a 5-minute physical exertion protocol, completed in a counterbalanced order.
MAIN OUTCOME MEASURES


Participants' performance on the various components of the SCAT3 under the 2 conditions: at rest and after a 5-minute physical exertion protocol.
RESULTS


No significant differences were detected between at-rest and postexercise conditions for the balance, orientation, or cognitive components of the SCAT3. There were no significant differences in the proportion of participants who endorsed specific symptoms at rest compared with the postexercise condition (P > 0.05). However, women athletes who rated their exertion after exercise as ""hard"" or greater (Borg scale rating 13-20) reported significantly greater blurred vision (M = 0.25, SD = 0.62 vs M = 0.00, SD = 0.00; P = 0.006) and fatigue/low energy (M = 1.38, SD = 1.17 vs M = 0.66, SD = 0.91; P = 0.002) symptoms after exercise than those who rated their exertion as ""light"" or lower (Borg scale rating 6-12).
CONCLUSIONS


In this study of women athletes, a brief bout of exercise did not seem to adversely affect SCAT3 performance and had only small effects on self-reported symptoms. There were differences in symptom reporting, however, in the subgroup of women who rated their exertion levels as ""hard"" or greater; they reported more blurred vision and fatigue/low energy.",2020,"No significant differences were detected between at-rest and postexercise conditions for the balance, orientation, or cognitive components of the SCAT3.","['87 amateur women athlete volunteers (age = 29.9, SD = 6.9 years', 'Women', 'women athletes', 'amateur women athletes', 'Off-season, uninjured community amateur athletes']","['Exercise', 'exercise protocol']","['SCAT3 performance', 'Sport Concussion Assessment Tool-Third Edition Performance', 'blurred vision and fatigue/low energy', 'balance, orientation, or cognitive components of the SCAT3', 'endorsed specific symptoms', 'fatigue/low energy', 'Sport Concussion Assessment Tool-Third Edition (SCAT3) performance', 'blurred vision']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0006107', 'cui_str': 'Cerebral Concussion'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0441796', 'cui_str': 'Third edition (qualifier value)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",87.0,0.109219,"No significant differences were detected between at-rest and postexercise conditions for the balance, orientation, or cognitive components of the SCAT3.","[{'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Chung Pin Yong', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Jin H', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'School of Human Movement and Nutrition Sciences, University of Queensland, Saint Lucia, Queensland, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Howell', 'Affiliation': 'The Micheli Center for Sports Injury Prevention, Waltham, Massachusetts.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Meehan', 'Affiliation': ""Division of Emergency Medicine, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Grant L', 'Initials': 'GL', 'LastName': 'Iverson', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Gardner', 'Affiliation': 'Centre for Stroke and Brain Injury, School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000605']
608,31862830,Middle meningeal artery embolization as an adjuvant treatment to surgery for symptomatic chronic subdural hematoma: a pilot study assessing hematoma volume resorption.,"BACKGROUND


Chronic subdural hematoma (CSDH) is a common condition requiring surgical treatment; however, recurrence occurs in 15% of cases at 1 year. Middle meningeal artery (MMA) embolization has recently emerged as a promising treatment to prevent CSDH recurrence.
OBJECTIVE


To investigate the effect of MMA embolization on hematoma volume resorption (HVR) after surgery in symptomatic patients.
METHODS


From April 2018 to October 2018, participants with CSDH requiring surgery were prospectively randomized in a pilot study, and received either surgical treatment alone (ST group) or surgery and adjuvant MMA embolization (ST+MMAE group). The primary outcome was HVR measured on the 3 month CT scan compared with the immediate pre-embolization CT scan. Secondary outcomes were clinical recurrence of CSDH and safety measures.
RESULTS


46 patients were randomized and 41 of these achieved a 3 month follow-up . Twenty-one patients received MMA embolization. At 3 months, the HVR from postsurgical level was higher in the ST+MMAE group (mean difference 17.5 mL, 95% CI 3.87 to 31.16 mL; p=0.015). Two participants presented a CSDH recurrence (one in each group). One patient died (ST group). No MMA embolization-related adverse events were reported.
CONCLUSION


The addition of MMA embolization to surgery led to an increase in CSDH resorption at 3 months. One recurrence of CSDH was reported in each group, and there were no treatment-related complications.",2020,"At 3 months, the HVR from postsurgical level was higher in the ST+MMAE group (mean difference 17.5 mL, 95% CI 3.87 to 31.16 mL; p=0.015).","['46 patients', 'From April 2018 to October 2018, participants with CSDH requiring surgery', 'symptomatic patients', 'symptomatic chronic subdural hematoma']","['MMA embolization', 'surgical treatment alone (ST group) or surgery and adjuvant MMA embolization (ST+MMAE group', 'Middle meningeal artery embolization', 'Middle meningeal artery (MMA) embolization']","['MMA embolization-related adverse events', 'CSDH recurrence', 'recurrence of CSDH', 'clinical recurrence of CSDH and safety measures', 'CSDH resorption', 'hematoma volume resorption (HVR', 'HVR from postsurgical level', 'HVR measured on the 3\u2009month CT scan']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0749095', 'cui_str': 'Hemorrhage, Subdural, Chronic'}]","[{'cui': 'C0916871', 'cui_str': 'MMA(III)'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0226147', 'cui_str': 'Structure of middle meningeal artery'}]","[{'cui': 'C0916871', 'cui_str': 'MMA(III)'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}]",46.0,0.100507,"At 3 months, the HVR from postsurgical level was higher in the ST+MMAE group (mean difference 17.5 mL, 95% CI 3.87 to 31.16 mL; p=0.015).","[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Ng', 'Affiliation': 'Department of Neurosurgery, Montpellier University Medical Center, Montpellier, Occitanie, France s-ng@chu-montpellier.fr.'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Derraz', 'Affiliation': 'Department of Neuroradiology, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Boetto', 'Affiliation': 'Department of Neurosurgery, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Dargazanli', 'Affiliation': 'Department of Neuroradiology, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Poulen', 'Affiliation': 'Department of Neurosurgery, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Gascou', 'Affiliation': 'Department of Neuroradiology, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Pierre-Henri', 'Initials': 'PH', 'LastName': 'Lefevre', 'Affiliation': 'Department of Neuroradiology, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Molinari', 'Affiliation': 'Department of Statistics, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Lonjon', 'Affiliation': 'Department of Neurosurgery, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Costalat', 'Affiliation': 'Department of Neuroradiology, Montpellier University Medical Center, Montpellier, Occitanie, France.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2019-015421']
609,31931026,Seven-year-efficacy of proximal caries infiltration - Randomized clinical trial.,"OBJECTIVES


We report efficacy of resin infiltration to arrest progression of caries lesions as compared with non-invasive measures and oral hygiene education alone after a mean observation time of seven years.
MATERIALS AND METHODS


This randomized split-mouth placebo-controlled clinical trial included 22 young adults having 29 pairs of interproximal non-cavitated caries lesions with radiographic extensions into inner half of enamel (E2) or outer third of dentin (D1). Lesion pairs were randomly allocated to two treatment groups: infiltration (Icon, pre-product; DMG) or mock (control) treatment. All subjects received risk-related instructions for diet, flossing and fluoridation. The primary outcome was radiographic (digital subtraction radiography) lesion progression after seven years. Secondly, Kaplan-Meier-analyses were applied to analyze time-to-failure additionally including patients followed up for less than 54 months as well.
RESULTS


Two lesion pairs were excluded due to invasive treatment decision by another dentist, five lesion pairs were lost to follow-up prior to 54 months but included in the survival analysis. No unwanted effects could be observed. For the primary outcome in 17 patients followed up in mean for 84 months 2/22 infiltrated lesions (9 %) compared with 10/22 control lesions (45 %) progressed (p = 0.018). The relative risk reduction for test in relation to control was 80 % (CI 95 % = 19-95 %). For the survival analysis within a mean (SD) observation time of 73 (25) months mean failure rates of 1.3 % and 7.8 % could be observed for test and controls, respectively. Hazard risk (95 % CI) for caries progression was 6.6 (2-22) for the control compared with the test lesions (p = 0.002).
CONCLUSIONS


We conclude that resin infiltration of proximal caries lesions extending radiographically around the enamel dentin junction is efficacious to reduce lesion progression after a mean observation time of seven years.
CLINICAL SIGNIFICANCE


This randomized clinical trial proves that caries infiltration is highly efficacious compared with non-invasive measures and oral hygiene education alone after a considerably longer observation time of 7 years than studied so far before.",2020,The relative risk reduction for test in relation to control was 80% (CI 95% = 19-95%).,"['22 young adults having 29 pairs of interproximal non-cavitated caries lesions with radiographic extensions into inner half of enamel (E2) or outer third of dentin (D1', 'Lesion pairs']","['placebo', 'resin infiltration', 'infiltration (Icon, pre-product; DMG) or mock (control) treatment']","['radiographic (digital subtraction radiography) lesion progression', 'Hazard risk', 'caries progression', 'relative risk reduction', 'failure rates']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4039194', 'cui_str': 'Non-cavitated caries (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C4041253', 'cui_str': 'Inner half of enamel'}, {'cui': 'C4038556', 'cui_str': 'Outer third of dentin (body structure)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0562577', 'cui_str': 'Mocking (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",22.0,0.208919,The relative risk reduction for test in relation to control was 80% (CI 95% = 19-95%).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Paris', 'Affiliation': 'Department of Operative Dentistry and Preventive Dentistry, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bitter', 'Affiliation': 'Department of Operative Dentistry and Preventive Dentistry, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Krois', 'Affiliation': 'Department of Operative Dentistry and Preventive Dentistry, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Meyer-Lueckel', 'Affiliation': 'Department of Restorative, Preventive & Pediatric Dentistry, University of Bern, Bern, Switzerland. Electronic address: hendrik.meyer-lueckel@zmk.unibe.ch.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103277']
610,31654276,"Effects of a Web-Based, Evolutionary Mismatch-Framed Intervention Targeting Physical Activity and Diet: a Randomised Controlled Trial.","BACKGROUND


This study sought to test the effectiveness of a 12-week, novel online intervention (Evolife) aiming to increase physical activity level (PAL) and reduce energy intake (EI) among overweight/obese adults. The intervention used an evolutionary mismatch message to frame health information in an engaging way, incorporating evidence-based behaviour change techniques to promote autonomous motivation, self-efficacy and self-regulatory skills.
METHOD


Men and women aged 35-74 years with a BMI of 25-40 kg/m 2  were eligible. Participants were randomised to receive either the intervention (comprising a face-to-face introductory session, 12 weeks' access to the Evolife website and a pedometer) or a control condition (face-to-face introductory session and NHS online health resources). PAL was measured objectively and EI was self-reported using 3-day weighed food records. Secondary measures included BMI, waist circumference and blood pressure.
RESULTS


Sixty people met inclusion criteria; 59 (30 intervention) completed the trial (mean age = 50; 56% male). Differences between groups' change scores for PAL and EI were of small effect size but did not reach significance (d = 0.32 and d = - 0.49, respectively). Improvements were found in both groups for PAL (int: d = 0.33; control: d = 0.04), EI (int: d = - 0.81; control: d = - 0.16), waist circumference (int: d = - 0.30; control: d = - 0.17) and systolic blood pressure (int: d = - 0.67; control: d = - 0.28).
CONCLUSION


The intervention did not lead to significantly greater improvement in PAL or reduction in EI than a minimal intervention control, although the changes in the intervention group were of meaningful effect size and comparable with positive outcomes in larger intervention trials.
TRIAL REGISTRATION


This trail was registered on www.clinicaltrials.gov on 16 January 2017 (appeared online 26 January 2017), reference NCT03032731.",2019,"The intervention did not lead to significantly greater improvement in PAL or reduction in EI than a minimal intervention control, although the changes in the intervention group were of meaningful effect size and comparable with positive outcomes in larger intervention trials.
","['overweight/obese adults', 'Sixty people met inclusion criteria; 59 (30 intervention) completed the trial (mean age = 50; 56% male', '16 January 2017 (appeared online 26 January 2017', 'Men and women aged 35-74 years with a BMI of 25-40 kg/m 2  were eligible']","['Web-Based, Evolutionary Mismatch-Framed Intervention Targeting Physical Activity and Diet', 'novel online intervention (Evolife', 'evolutionary mismatch message to frame health information in an engaging way, incorporating evidence-based behaviour change techniques', ""intervention (comprising a face-to-face introductory session, 12 weeks' access to the Evolife website and a pedometer) or a control condition (face-to-face introductory session and NHS online health resources""]","['waist circumference (int', 'physical activity level (PAL) and reduce energy intake (EI', 'PAL', 'BMI, waist circumference and blood pressure', 'systolic blood pressure']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C1271922', 'cui_str': 'Target physical activity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}]","[{'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",60.0,0.0961243,"The intervention did not lead to significantly greater improvement in PAL or reduction in EI than a minimal intervention control, although the changes in the intervention group were of meaningful effect size and comparable with positive outcomes in larger intervention trials.
","[{'ForeName': 'Elisabeth B', 'Initials': 'EB', 'LastName': 'Grey', 'Affiliation': 'Centre for Motivation and Health Behaviour Change, Department for Health, University of Bath, Bath, BA2 7AY, UK. e.b.grey@bath.ac.uk.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Fiona B', 'Initials': 'FB', 'LastName': 'Gillison', 'Affiliation': 'Centre for Motivation and Health Behaviour Change, Department for Health, University of Bath, Bath, BA2 7AY, UK.'}]",International journal of behavioral medicine,['10.1007/s12529-019-09821-3']
611,30241517,"Methods for conducting a double-blind randomized controlled clinical trial of three days versus five days of amoxicillin dispersible tablets for chest indrawing childhood pneumonia among children two to 59 months of age in Lilongwe, Malawi: a study protocol.","BACKGROUND


Pneumonia is the leading infectious cause of death in children under 5 years of age around the globe. In addition to preventing pneumonia, there is a critical need to provide greater access to appropriate and effective treatment. Studies in Asia have evaluated the effectiveness of 3 days of oral amoxicillin for the treatment of fast-breathing pneumonia; however, further evidence is needed to determine if 3 days of oral amoxicillin is also effective for the treatment of chest indrawing pneumonia.
METHODS


This is a double-blind, randomized, non-inferiority trial with the objective to assess the effectiveness of shorter duration amoxicillin dispersible tablet (DT) treatment of chest indrawing childhood pneumonia in a malaria-endemic region of Malawi. The primary objective of this study is to determine whether 3 days of treatment with oral amoxicillin DT in HIV-uninfected Malawian children two to 59 months of age with chest indrawing pneumonia is as effective as 5 days of treatment. The study will enroll 2000 children presenting to Kamuzu Central or Bwaila District Hospitals in Lilongwe, Malawi. Each child will be randomized to either 3 days of amoxicillin DT followed by 2 days of placebo DT or 5 days of amoxicillin DT. Children in the study will be hospitalized for 48 h after enrollment and will have scheduled study visits at Days 2, 4, 6 and 14. Treatment failure by Day 6 is the primary outcome. We hypothesize that the rates of treatment failure will be similar in both arms and that 3 days of treatment will be non-inferior to 5 days of amoxicillin DT for chest indrawing pneumonia using a relative non-inferiority margin of 1.5. This trial was approved by the Western Institutional Review Board and Malawi College of Medicine Research and Ethics Committee.
DISCUSSION


Given the paucity of data from Africa, African-based research is necessary to establish appropriate duration of treatment with amoxicillin DT for chest indrawing childhood pneumonia in malaria-endemic settings in the region. An expanded evidence base will contribute to future iterations of World Health Organization Integrated Management of Childhood Illness guidelines.
TRIAL REGISTRATION


NCT02678195 : Pre-results. Date registered February 9, 2016.",2018,"Studies in Asia have evaluated the effectiveness of 3 days of oral amoxicillin for the treatment of fast-breathing pneumonia; however, further evidence is needed to determine if 3 days of oral amoxicillin is also effective for the treatment of chest indrawing pneumonia.
","['children under 5\xa0years of age around the globe', 'chest indrawing childhood pneumonia in a malaria-endemic region of Malawi', 'HIV-uninfected Malawian children two to 59\xa0months of age with chest indrawing pneumonia', '2000 children presenting to Kamuzu Central or Bwaila District Hospitals in Lilongwe, Malawi', 'chest indrawing childhood pneumonia among children two to 59\xa0months of age in Lilongwe, Malawi', 'Children in the study will be hospitalized for 48\xa0h after enrollment and will have scheduled study visits at Days 2, 4, 6 and 14']","['placebo DT', 'amoxicillin', 'amoxicillin DT', 'amoxicillin dispersible tablets', 'amoxicillin dispersible tablet (DT', 'oral amoxicillin DT']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0020006', 'cui_str': 'Hospitals, District'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",[],2000.0,0.300273,"Studies in Asia have evaluated the effectiveness of 3 days of oral amoxicillin for the treatment of fast-breathing pneumonia; however, further evidence is needed to determine if 3 days of oral amoxicillin is also effective for the treatment of chest indrawing pneumonia.
","[{'ForeName': 'Amy Sarah', 'Initials': 'AS', 'LastName': 'Ginsburg', 'Affiliation': 'Save the Children, Seattle, Washington, USA. aginsburg@savechildren.org.'}, {'ForeName': 'Susanne J', 'Initials': 'SJ', 'LastName': 'May', 'Affiliation': 'University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Evangelyn', 'Initials': 'E', 'LastName': 'Nkwopara', 'Affiliation': 'Save the Children, Seattle, Washington, USA.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Ambler', 'Affiliation': 'PATH, Seattle, Washington, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'McCollum', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Tisungane', 'Initials': 'T', 'LastName': 'Mvalo', 'Affiliation': 'University of North Carolina Project Lilongwe Trust, Lilongwe, Malawi.'}, {'ForeName': 'Ajib', 'Initials': 'A', 'LastName': 'Phiri', 'Affiliation': 'Malawi College of Medicine, Lilongwe, Malawi.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Lufesi', 'Affiliation': 'Malawi Ministry of Health, Lilongwe, Malawi.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Sadruddin', 'Affiliation': 'World Health Organization, Geneva, Switzerland.'}]",BMC infectious diseases,['10.1186/s12879-018-3379-z']
612,31335838,Vitamin D Supplementation and T Cell Regulation in Preterm Infants: A Randomized Controlled Trial.,"The objective of this study was to evaluate the effect of 2 different doses of vitamin D on the expression of T regulatory cells (Treg) in premature infants. A double-blind randomized controlled trial was conducted on preterm infants born with gestational age between 28 and 33 weeks. Subjects were randomly assigned to receive 400 or 800 IU/day of vitamin D3 when they achieved 100 mL/kg of enteral feeds. Percentage increase in Treg cell counts were measured by flow cytometry at enrollment, and after 1 and 4 weeks of oral vitamin D supplementation at the allotted doses in both groups. Short-term morbidity and mortality outcomes were also assessed. A total of 40 infants were enrolled, 20 in each group. The change in Treg count (%) was significantly less in the low-dose vitamin D3 supplementation group after 1 week (1.9 ± 5.5 vs 60 ± 5.6, P = 0.0005) and after 4 weeks (1.8 ± 5.7 vs 73.7 ± 5.6, P = 0.0028). The 2 groups did not differ in anthropometric measurements, duration of oxygen and respiratory support, and mortality. Length of hospital stay was longer in the low-dose group (24.9 ± 5.14 vs 22 ± 3.49, P = 0.04). Oral vitamin D supplementation has a dose and time dependent effect on percentage of Treg in infants born prematurely. The 800 IU dose of vitamin D3 did not have apparent short-term side effects. Larger studies are needed to explore the effect of vitamin D3 dosing on length of hospital stay.",2019,"The change in Treg count (%) was significantly less in the low-dose vitamin D3 supplementation group after one week (1.9 ± 5.5 vs 60 ± 5.6, p = 0.0005) and after four weeks (1.8 ± ","['premature infants', 'preterm infants born with gestational age (GA) between 28 and 33weeks', '40 infants were enrolled, 20 in each group', 'infants born prematurely', 'Preterm Infants']","['vitamin D3 supplementation', 'vitamin D3', 'Oral vitamin D supplementation', 'vitamin D', 'oral vitamin D supplementation', 'Vitamin D supplementation and T Cell Regulation']","['Length of hospital stay', 'Treg cell counts', 'anthropometric measurements, duration of oxygen and respiratory support, and mortality', 'Short-term morbidity and mortality outcomes']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0039198', 'cui_str': 'T-Cells, Regulatory'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.424594,"The change in Treg count (%) was significantly less in the low-dose vitamin D3 supplementation group after one week (1.9 ± 5.5 vs 60 ± 5.6, p = 0.0005) and after four weeks (1.8 ± ","[{'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Aly', 'Affiliation': ""Department of Neonatology, Cleveland Clinic Children's, Cleveland, OH.""}, {'ForeName': 'Lamiaa', 'Initials': 'L', 'LastName': 'Mohsen', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Cairo University.'}, {'ForeName': 'Indrani', 'Initials': 'I', 'LastName': 'Bhattacharjee', 'Affiliation': ""Department of Neonatology, Cleveland Clinic Children's, Cleveland, OH.""}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Malash', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Cairo University.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Atyia', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Cairo University.'}, {'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Elanwary', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Cairo University.'}, {'ForeName': 'Rabab', 'Initials': 'R', 'LastName': 'El Hawary', 'Affiliation': 'Clinical and Chemical Pathology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002448']
613,30004987,Outcomes in Patients with Vasodilatory Shock and Renal Replacement Therapy Treated with Intravenous Angiotensin II: Erratum.,,2018,,['Patients with Vasodilatory Shock and Renal Replacement Therapy Treated with'],['Intravenous Angiotensin II'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}]",[],,0.0282702,,[],Critical care medicine,['10.1097/CCM.0000000000003226']
614,29952839,Enhanced External Counterpulsation and Recovery From a Plyometric Exercise Bout.,"OBJECTIVE


To analyze the effectiveness of enhanced external counterpulsation (EECP) on recovery from exercise-induced muscle damage (EIMD).
DESIGN


This study followed a crossover, placebo-controlled, counterbalanced design.
PARTICIPANTS


Ten healthy active subjects (7 male; 27 ± 4 years).
INTERVENTIONS


Participants performed a plyometric exercise bout (10 sets of 10 jumps interspersed with 1-minute rests) and were then assigned to recover for 30 minutes with either EECP (cuff pressure = 80 mm Hg) or a Sham intervention (0 mm Hg) immediately after exercise and at 24 hours after exercise. Two weeks later, they repeated the protocol with the other recovery intervention.
MAIN OUTCOME MEASURES


Muscle soreness, creatine kinase (CK) activity, jump performance, and tensiomyographic variables were measured before exercise, and 24 and 48 hours after exercise.
RESULTS


The mean jump height of the plyometric bout did not differ between EECP and Sham (P > 0.05). Exercise resulted in increased muscle soreness (P < 0.001) and CK levels (P < 0.001), as well as in impaired jump performance (P < 0.05). No changes were observed in tensiomyographic variables. No significant differences were found between interventions for any of the study outcomes.
CONCLUSIONS


No benefits on recovery from EIMD after a plyometric exercise bout were observed with EECP.",2020,"Exercise resulted in increased muscle soreness (P < 0.001) and CK levels (P < 0.001), as well as in impaired jump performance (P < 0.05).",['Ten healthy active subjects (7 male; 27 ± 4 years'],"['enhanced external counterpulsation (EECP', 'placebo', 'EECP (cuff pressure = 80 mm Hg) or a Sham intervention', 'EECP', 'plyometric exercise bout', 'Plyometric Exercise Bout']","['tensiomyographic variables', 'impaired jump performance', 'muscle soreness', 'mean jump height of the plyometric bout', 'Muscle soreness, creatine kinase (CK) activity, jump performance, and tensiomyographic variables', 'CK levels']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0010217', 'cui_str': 'Counterpulsation, External'}, {'cui': 'C1640731', 'cui_str': 'Enhanced external counterpulsation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Training'}]","[{'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",10.0,0.115258,"Exercise resulted in increased muscle soreness (P < 0.001) and CK levels (P < 0.001), as well as in impaired jump performance (P < 0.05).","[{'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Valenzuela', 'Affiliation': 'Physiology Unit, Systems Biology Department, University of Alcalá, Madrid, Spain.'}, {'ForeName': 'Zigor', 'Initials': 'Z', 'LastName': 'Montalvo', 'Affiliation': 'Department of Sport and Health, Spanish Agency for Health Protection in Sport (AEPSAD), Madrid, Spain.'}, {'ForeName': 'Elaia', 'Initials': 'E', 'LastName': 'Torrontegi', 'Affiliation': 'Department of Sport and Health, Spanish Agency for Health Protection in Sport (AEPSAD), Madrid, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Sánchez-Martínez', 'Affiliation': 'Department of Sport and Health, Spanish Agency for Health Protection in Sport (AEPSAD), Madrid, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lucia', 'Affiliation': 'Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'de la Villa', 'Affiliation': 'Physiology Unit, Systems Biology Department, University of Alcalá, Madrid, Spain.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000620']
615,31261247,Evaluation of a Novel Educational Tool in Adolescents With Inflammatory Bowel Disease: The NEAT Study.,"OBJECTIVES


Among adolescents with inflammatory bowel disease (IBD), nonadherence rates are 50 to 88% across medications. Improving education in adults with IBD has been shown to improve coping and adherence to treatment in adults with IBD. Therapeutic patient education (TPE) has been used in patients with chronic diseases to train patients in skills to support treatment adaptation and condition management. This study tested the feasibility and preliminary efficacy of a novel TPE intervention in adolescents with IBD.
METHODS


In this pilot, mixed-methods study, we evaluated the feasibility and preliminary efficacy of TPE with the IBD Pocket Guide on medication adherence, IBD knowledge, and transition readiness in adolescents ages 11 to 18 years. Medication adherence was monitored using a MedMinder Pill Dispensing system. Participants who were <90% adherent during a 4-week pre-intervention monitoring period were randomized to either a usual care group or an educational intervention (EI) group. Participants were followed for an additional 4 weeks after intervention.
RESULTS


Trends were found in the EI group indicating improved medication adherence and IBD knowledge compared with the usual care group, though differences between groups did not reach statistical significance. Qualitative data showed that participants perceived that they had improved knowledge after the educational intervention.
CONCLUSIONS


Therapeutic patient education may be beneficial for improving patient medication adherence and IBD knowledge. Future directions include testing the effects of the intervention with a larger sample.",2019,"RESULTS


Trends were found in the EI group indicating improved medication adherence and IBD knowledge compared to the usual care group, though differences between groups did not reach statistical significance.","['adults with IBD', 'Participants who were <90% adherent during a 4 week pre-intervention monitoring period', 'patients with chronic diseases to train patients', 'adolescents aged 11-18 years', 'adolescents with IBD', 'adolescents with Inflammatory Bowel Disease (IBD', 'Adolescents with Inflammatory Bowel Disease']","['usual care group or an educational intervention (EI) group', 'novel TPE intervention', 'Therapeutic patient education (TPE', 'TPE', 'Novel Educational Tool']","['medication adherence and IBD knowledge', 'medication adherence, IBD knowledge and transition readiness', 'Medication adherence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0439087', 'cui_str': '<90 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}]",,0.0332146,"RESULTS


Trends were found in the EI group indicating improved medication adherence and IBD knowledge compared to the usual care group, though differences between groups did not reach statistical significance.","[{'ForeName': 'Karla K H', 'Initials': 'KKH', 'LastName': 'Vaz', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Schubert-Martin Inflammatory Bowel Disease Center.""}, {'ForeName': 'Julia K', 'Initials': 'JK', 'LastName': 'Carmody', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Bioinformatics and Biostatistics, School of Life Sciences and Biotechnology, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Denson', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Schubert-Martin Inflammatory Bowel Disease Center.""}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Hommel', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002431']
616,30372680,A Randomized Controlled Trial of Adherence to a 24-Month Home-Based Physical Activity Program and the Health Benefits for Older Adults at Risk of Alzheimer's Disease: The AIBL Active-Study.,"BACKGROUND


Previous studies have demonstrated that physical activity (PA) interventions can improve physical and cognitive outcomes in older adults, but most have been relatively short in duration (<1 year) with a few having specifically targeting individuals at risk of developing Alzheimer's disease.
OBJECTIVE


To examine adherence and physical health outcomes in a 24-month home-based PA intervention in older adults at risk of Alzheimer's disease.
METHODS


Participants 60 years and older with mild cognitive impairment (MCI) or subjective memory complaints (SMC) with at least 1 cerebrovascular risk factor recruited from The Australian Imaging Biomarkers and Lifestyle Flagship Study of Aging (AIBL) were randomized to a PA or control group (n = 106). The control group continued with their usual lifestyle. The PA group received a 24-month home-based program with a target of 150 minutes/week of moderate PA and a behavioral intervention. Retention (participants remaining) and PA adherence (PA group only, percent PA completed to the PA prescribed) were determined at 6, 12, 18, and 24 months. Assessments at baseline, 6, 12, and 24 months included, PA; fitness; body composition and fat distribution. Key outcome measures were PA adherence and PA.
RESULTS


The 24-month retention rate (97.2%) and the median PA adherence 91.67% (Q1-Q3, 81.96, 100.00) were excellent. In the long-term the intervention group achieved significantly better improvements in PA levels, leg strength, fat mass and fat distribution compared to the control.
CONCLUSION


This study demonstrates that in this target group, long-term PA adherence is achievable and has physical health benefits.",2019,"In the long-term the intervention group achieved significantly better improvements in PA levels, leg strength, fat mass and fat distribution compared to the control.
","[""older adults at risk of Alzheimer's disease"", 'Participants 60 years and older with mild cognitive impairment (MCI) or subjective memory complaints (SMC) with at least 1 cerebrovascular risk factor recruited from The Australian Imaging Biomarkers and Lifestyle Flagship Study of Aging (AIBL', ""Older Adults at Risk of Alzheimer's Disease"", 'older adults']","['physical activity (PA) interventions', '24-month home-based program with a target of 150 minutes/week of moderate PA and a behavioral intervention', 'home-based PA intervention', '24-Month Home-Based Physical Activity Program']","['median PA adherence', 'PA levels, leg strength, fat mass and fat distribution', 'PA; fitness; body composition and fat distribution', 'PA adherence and PA', '24-month retention rate']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",,0.0389063,"In the long-term the intervention group achieved significantly better improvements in PA levels, leg strength, fat mass and fat distribution compared to the control.
","[{'ForeName': 'Kay L', 'Initials': 'KL', 'LastName': 'Cox', 'Affiliation': 'Medical School University of Western Australia, Perth, Australia.'}, {'ForeName': 'Elizabeth V', 'Initials': 'EV', 'LastName': 'Cyarto', 'Affiliation': 'Bolton Clarke Research Institute, Melbourne, Australia.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Ellis', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ames', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Desmond', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Australia.'}, {'ForeName': 'Pramit', 'Initials': 'P', 'LastName': 'Phal', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Australia.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Sharman', 'Affiliation': 'School of Health Sciences, University of Tasmania, Launceston, Tasmania, Australia.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Szoeke', 'Affiliation': 'Department of Medicine (Royal Melbourne Hospital), University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Rowe', 'Affiliation': 'Department of Molecular Imaging & Therapy, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Colin L', 'Initials': 'CL', 'LastName': 'Masters', 'Affiliation': 'The Florey Institute, The University of Melbourne, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'You', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Burrows', 'Affiliation': 'Medical School University of Western Australia, Perth, Australia.'}, {'ForeName': 'Michelle M Y', 'Initials': 'MMY', 'LastName': 'Lai', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Nicola T', 'Initials': 'NT', 'LastName': 'Lautenschlager', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-180521']
617,31645229,Feasibility and efficacy of a hospital-based violence intervention program on reducing repeat violent injury in youth: a randomized control trial.,"OBJECTIVES


To determine feasibility and efficacy of an Emergency Department Violence Intervention Program (EDVIP) to reduce violence related injuries in youth.
METHODS


One hundred and thirty youth aged 14-24 presenting to an emergency with violence related injury were randomized in parallel to receive EDVIP for 1 year (n = 65) or a waitlist control (n = 65). The primary outcome was to determine feasibility. Secondary outcomes are incidence, number/severity of repeat violence related injury, justice and education systems interactions, substance misuse and mental health presentations, and ED length of stay (LOS).
RESULTS


This study established feasibility in recruitment, outcomes collection and safety. Fidelity and adherence measures required optimization during the study. Efficacy analysis of EDVIP vs. the control group demonstrates an absolute decrease of 10.4% in repeat violence related injury (13.7% vs. 24.1%) (p = 0.15), reduction in new interactions in the justice system (OR = 0.36 (0.07-1.77)), improved engagement in education (11.8% EDVIP vs. 7.6% control, p = 0.42) and no change in repeat visits for substance or mental health. LOS decreased by 59.5 min (p = 0.21).
CONCLUSIONS


This program is feasible for ED implementation and for completion of a future RCT to measure effectiveness.",2020,"Efficacy analysis of EDVIP vs. the control group demonstrates an absolute decrease of 10.4% in repeat violence related injury (13.7% vs. 24.1%) (p = 0.15), reduction in new interactions in the justice system (OR = 0.36 (0.07-1.77)), improved engagement in education (11.8% EDVIP vs. 7.6% control, p = 0.42) and no change in repeat visits for substance or mental health.","['youth', 'One hundred and thirty youth aged 14-24 presenting to an emergency with violence related injury', 'violence related injuries in youth']","['waitlist control', 'EDVIP', 'hospital-based violence intervention program', 'Emergency Department Violence Intervention Program (EDVIP']","['Feasibility and efficacy', 'LOS', 'incidence, number/severity of repeat violence related injury, justice and education systems interactions, substance misuse and mental health presentations, and ED length of stay (LOS', 'improved engagement in education']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0022437', 'cui_str': 'Justice'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",130.0,0.12209,"Efficacy analysis of EDVIP vs. the control group demonstrates an absolute decrease of 10.4% in repeat violence related injury (13.7% vs. 24.1%) (p = 0.15), reduction in new interactions in the justice system (OR = 0.36 (0.07-1.77)), improved engagement in education (11.8% EDVIP vs. 7.6% control, p = 0.42) and no change in repeat visits for substance or mental health.","[{'ForeName': 'Carolyn E', 'Initials': 'CE', 'LastName': 'Snider', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, ON.""}, {'ForeName': 'Depeng', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'College of Medicine, University of Manitoba, Winnipeg, MB.'}, {'ForeName': 'Sarvesh', 'Initials': 'S', 'LastName': 'Logsetty', 'Affiliation': 'College of Medicine, University of Manitoba, Winnipeg, MB.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Chernomas', 'Affiliation': 'College of Nursing, University of Manitoba, Winnipeg, MB.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Mordoch', 'Affiliation': 'College of Nursing, University of Manitoba, Winnipeg, MB.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Cochrane', 'Affiliation': 'First Nations Health and Social Secretariat of Manitoba, Winnipeg, MB.'}, {'ForeName': 'Jamil', 'Initials': 'J', 'LastName': 'Mahmood', 'Affiliation': 'Spence Neighbourhood Association, Winnipeg, MB.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Woodward', 'Affiliation': 'College of Medicine, University of Manitoba, Winnipeg, MB.'}, {'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Klassen', 'Affiliation': 'College of Medicine, University of Manitoba, Winnipeg, MB.'}]",CJEM,['10.1017/cem.2019.406']
618,31646339,Warrior Wellness: A Randomized Controlled Pilot Trial of the Effects of Exercise on Physical Function and Clinical Health Risk Factors in Older Military Veterans With PTSD.,"BACKGROUND


Military veterans living with post-traumatic stress disorder (PTSD) face significant physical and functional health disparities, which are often aggravated over time and in the context aging. Evidence has shown that physical activity can positively impact age-related health conditions, yet exercise trials in older adults with mental disorders are rare. Our study was a tailored and targeted pilot exercise intervention for older veterans with PTSD.
METHODS


Fifty-four older veterans with PTSD (mean age = 67.4 years, 90.7% male, 85.2% non-white) were randomized to supervised exercise (n = 38) or wait-list usual care (n = 18) for 12 weeks. Physical activity (MET-min/wk) and aerobic endurance (assessed with the 6-minute walk test) were primary outcomes. Secondary outcomes were physical performance (strength, mobility, balance), cardiometabolic risk factors (eg, waist circumference), and health-related quality of life.
RESULTS


At 12 weeks, a large effect of the intervention on physical activity levels (Cohen's d = 1.37) was observed compared to wait-list usual care. Aerobic endurance improved by 69 m in the exercise group compared to 10 m in wait-list group, reflecting a moderate between-group effect (Cohen's d = 0.50). Between-group differences on 12-week changes in physical performance, cardiometabolic risk factors, and health-related quality of life ranged from small to large effects (Cohen's d = 0.28-1.48), favoring the exercise arm.
CONCLUSION


Participation in supervised exercise improved aerobic endurance, physical performance, and health-related clinical factors in older veterans with PTSD; a medically complex population with multiple morbidity. Group exercise is a low-cost, low-stigma intervention, and implementation efforts among older veterans with PTSD warrants further consideration.",2020,"At 12 weeks, a large effect of the intervention on physical activity levels (Cohen's d=1.37) was observed compared to WL.","['Warrior Wellness', 'Fifty-four older veterans with PTSD (mean age = 67.4 years, 90.7% male, 85.2% non-white', 'Military veterans living with posttraumatic stress disorder (PTSD', 'older veterans with PTSD', 'older military veterans with PTSD', 'older adults with mental disorders']","['exercise', 'pilot exercise intervention', 'Participation in supervised exercise', 'supervised exercise (n=38) or wait-list usual care']","['physical performance (strength, mobility, balance), cardiometabolic risk factors (e.g., waist circumference), and health-related quality of life', 'physical function and clinical health risk factors', 'Aerobic endurance', 'physical activity levels', 'Physical activity (MET-min/wk) and aerobic endurance', 'aerobic endurance, physical performance, and health-related clinical factors', 'physical performance, cardiometabolic risk factors, and health-related quality of life']","[{'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C2607857'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",54.0,0.0263937,"At 12 weeks, a large effect of the intervention on physical activity levels (Cohen's d=1.37) was observed compared to WL.","[{'ForeName': 'Katherine S', 'Initials': 'KS', 'LastName': 'Hall', 'Affiliation': 'VA Durham Healthcare System, Geriatric Research, Education, and Clinical Center, North Carolina.'}, {'ForeName': 'Miriam C', 'Initials': 'MC', 'LastName': 'Morey', 'Affiliation': 'VA Durham Healthcare System, Geriatric Research, Education, and Clinical Center, North Carolina.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Beckham', 'Affiliation': 'VA Durham Healthcare System, Mental Illness Research, Education, and Clinical Center, North Carolina.'}, {'ForeName': 'Hayden B', 'Initials': 'HB', 'LastName': 'Bosworth', 'Affiliation': 'Department of Population Health Sciences, Duke University, Durham, North Carolina.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sloane', 'Affiliation': 'VA Durham Healthcare System, Geriatric Research, Education, and Clinical Center, North Carolina.'}, {'ForeName': 'Carl F', 'Initials': 'CF', 'LastName': 'Pieper', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Pebole', 'Affiliation': 'VA Durham Healthcare System, Geriatric Research, Education, and Clinical Center, North Carolina.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz255']
619,29359178,The Impact of Saffron on Symptoms of Withdrawal Syndrome in Patients Undergoing Maintenance Treatment for Opioid Addiction in Sabzevar Parish in 2017.,"Background and Objective


Drug dependence is one of the serious problems around the world. Saffron is one of those beneficial medicinal plants which is embedded with a similar mechanism to methadone (e.g., inhibition of serotonin reuptake). Thus, it can be helpful in reducing the withdrawal symptoms. The aim of this study was to reduce the daily dose of methadone usage and reduce its side effects using saffron in the form of medicinal supplements.
Methodology


This study was categorized as a clinical trial. Accordingly, 44 clients of addiction treatment centers in Sabzevar parish were randomly selected to participate in this study in 2016-2017. While the experimental group was treated with methadone syrup and self-made saffron capsules, the control group received methadone syrup and placebo capsules.
Results


The results showed that the use of saffron and methadone alleviated the symptoms of withdrawal syndrome ( p<0 .001).
Conclusion


Having reviewed the research participants, it was indicated that the introduction of saffron alleviated the symptoms of withdrawal syndrome in patients undergoing maintenance treatment for opioid addiction. Thus, it seems rational to make use of saffron in combination with methadone in order to alleviate the symptoms of withdrawal syndrome.",2017,"The results showed that the use of saffron and methadone alleviated the symptoms of withdrawal syndrome ( p<0 .001).
","['44 clients of addiction treatment centers in Sabzevar parish were randomly selected to participate in this study in 2016-2017', 'patients undergoing maintenance treatment for opioid addiction', 'Patients Undergoing Maintenance Treatment for Opioid Addiction in Sabzevar Parish in 2017']","['Saffron', 'methadone', 'methadone syrup and placebo capsules', 'methadone syrup and self-made saffron capsules']",['symptoms of withdrawal syndrome'],"[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0524662', 'cui_str': 'Opiate Dependence'}]","[{'cui': 'C2348128', 'cui_str': 'Saffron'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0458173', 'cui_str': 'Syrup (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038587', 'cui_str': 'Substance Withdrawal Syndrome'}]",,0.0243692,"The results showed that the use of saffron and methadone alleviated the symptoms of withdrawal syndrome ( p<0 .001).
","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Nemat Shahi', 'Affiliation': 'Sabzevar University of Medical Sciences, Abaresh, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Asadi', 'Affiliation': 'Health Department, Sabzevar University of Medical Sciences, Abaresh, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Behnam Talab', 'Affiliation': 'Sabzevar University of Medical Sciences, Abaresh, Iran.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Nemat Shahi', 'Affiliation': 'Sabzevar University of Medical Sciences, Abaresh, Iran.'}]",Advances in medicine,['10.1155/2017/1079132']
620,31347100,Simplifying Complex Insulin Regimens While Preserving Good Glycemic Control in Type 2 Diabetes.,"INTRODUCTION


Type 2 diabetic patients suffering from severe hyperglycemia are often assigned a regimen involving multiple daily injections (MDI) of insulin. If the glucose toxicity resolves, the regimen can potentially be simplified, but there are no guidelines for this, and many patients are left on the MDI regimen. We aimed to prospectively examine the safety and efficacy of switching from MDI to once-daily IDegLira, a fixed-ratio combination of insulin degludec and liraglutide, in relatively well controlled (HbA1c ≤ 7.5%) subjects with type 2 diabetes on a low total daily insulin dose (TDD).
METHODS


62 adults with type 2 diabetes (baseline age 64.06 ± 10.24 years, HbA 1c  6.42 ± 0.68%, BMI 33.53 ± 6.90 kg/m 2 , body weight 93.81 ± 19.26 kg, TDD 43.31 ± 10.99 IU/day, insulin requirement 0.47 ± 0.13 IU/kg, duration of diabetes 10.84 ± 7.50 years, mean ± SD) treated with MDI ± metformin were enrolled in our study. Previous insulins were stopped and once-daily IDegLira was started. IDegLira was titrated by the patients to achieve a self-measured pre-breakfast blood glucose concentration of < 6 mmol/L.
RESULTS


After a mean follow-up period of 99.2 days, mean HbA 1c  had decreased by 0.30% to 6.12 ± 0.65% (p < 0.0001), body weight had decreased by 3.11 kg to 90.70 ± 19.12 kg (p < 0.0001), and BMI had reduced to 32.39 ± 6.71 kg/m 2  (p < 0.0001). After 3 months of treatment, the mean dose of IDegLira was 20.76 ± 6.60 units and the mean insulin requirement had decreased to 0.23 ± 0.08 IU/kg. IDegLira ± metformin combination therapy was found to be safe and generally well tolerated. During the month before the baseline visit, 28 patients (45%) had at least one episode of documented or symptomatic hypoglycemia, while only 6 (9.67%) patients reported a total of 13 documented episodes during the follow-up.
CONCLUSION


In everyday clinical practice, switching from low-dose MDI to IDegLira in patients with well-controlled type 2 diabetes is safe, may result in weight loss and similar or better glycemic control, and substantially reduces the insulin requirement. Simplifying complex treatment regimens decreases treatment burden and may improve adherence to therapy.
CLINICAL TRIAL NUMBER


NCT04020445.",2019,IDegLira ± metformin combination therapy was found to be safe and generally well tolerated.,"['relatively well controlled (HbA1c\u2009≤\u20097.5%) subjects with type 2 diabetes on a low total daily insulin dose (TDD', 'patients with well-controlled type 2 diabetes', 'diabetic patients suffering from severe hyperglycemia', 'Type 2 Diabetes', '62 adults with type 2 diabetes (baseline age 64.06\u2009±\u200910.24\xa0years, HbA 1c  6.42\u2009±\u20090.68%, BMI 33.53\u2009±\u20096.90\xa0kg/m 2 , body weight 93.81\u2009±\u200919.26\xa0kg, TDD 43.31\u2009±\u200910.99\xa0IU/day, insulin requirement 0.47\u2009±\u20090.13\xa0IU/kg, duration of diabetes 10.84\u2009±\u20097.50\xa0years, mean\u2009±\u2009SD) treated with MDI\u2009±']","['metformin combination therapy', 'metformin', 'switching from MDI to once-daily IDegLira, a fixed-ratio combination of insulin degludec and liraglutide']","['IDegLira', 'mean dose of IDegLira', 'symptomatic hypoglycemia', 'mean insulin requirement', 'BMI', 'safe and generally well tolerated', 'mean HbA 1c', 'body weight', 'safety and efficacy']","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0183841', 'cui_str': 'Telecommunications Devices for the Deaf'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517473', 'cui_str': '0.68'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C4517428', 'cui_str': '0.13 (qualifier value)'}, {'cui': 'C0439463', 'cui_str': 'international unit/kilogram'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4059165', 'cui_str': 'insulin degludec / liraglutide'}]","[{'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",62.0,0.0433742,IDegLira ± metformin combination therapy was found to be safe and generally well tolerated.,"[{'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Taybani', 'Affiliation': '1st Department of Endocrinology, Dr. Réthy Pál Member Hospital, Békés County Central Hospital, Gyulai street 18, Békéscsaba, 5600, Hungary. taybanizoltan@gmail.com.'}, {'ForeName': 'Balázs', 'Initials': 'B', 'LastName': 'Bótyik', 'Affiliation': '1st Department of Endocrinology, Dr. Réthy Pál Member Hospital, Békés County Central Hospital, Gyulai street 18, Békéscsaba, 5600, Hungary.'}, {'ForeName': 'Mónika', 'Initials': 'M', 'LastName': 'Katkó', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Faculty of Medicine, University of Debrecen, Nagyerdei krt. 98, Debrecen, 4032, Hungary.'}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Gyimesi', 'Affiliation': '1st Department of Endocrinology, Dr. Réthy Pál Member Hospital, Békés County Central Hospital, Gyulai street 18, Békéscsaba, 5600, Hungary.'}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Várkonyi', 'Affiliation': '1st Department of Internal Medicine, University of Szeged, Korányi fasor 8, Szeged, 6720, Hungary.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-019-0673-8']
621,29455384,Novel Interventions to Reduce Stress and Overeating in Overweight Pregnant Women: A Feasibility Study.,"Background High stress and depression during pregnancy are risk factors for worsened health trajectories for both mother and offspring. This is also true for pre-pregnancy obesity and excessive gestational weight gain. Reducing stress and depression may be one path to prevent excessive caloric intake and gestational weight gain. Study Purpose We tested the feasibility of two novel interventions aimed at reducing stress and overeating during pregnancy. Reflecting different theoretical underpinnings, the interventions target different mechanisms. Mindful Moms Training (MMT) uses mindfulness to improve awareness and acceptance of experiences and promote conscious rather than automatic behavior choices. Emotional Brain Training (EBT) uses active coping to change perceptions of negative experience and promote positive affective states. Methods Forty-six overweight/obese low-income women were assigned to either MMT (n = 24) or EBT (n = 22) for an 8-week feasibility study. Pre-post changes in perceived stress, eating and presumed mechanisms were assessed. Results Women reported high levels of stress at baseline. Both interventions were well attended and demonstrated clinically significant pre-post reductions in stress, depressive symptoms, and improved eating behaviors. MMT significantly decreased experiential avoidance, whereas EBT significantly increased positive reappraisal; these changes were marginally significantly different by group. Conclusions This feasibility study found that both interventions promoted meaningful reductions in stress and depressive symptoms and improved reported eating behaviors in a high-risk group of pregnant women. Each intervention has a potentially different pathway-acceptance for MMT and reappraisal for EBT. Larger studies are needed to test efficacy on longer term reductions in stress and overeating.",2018,"Both interventions were well attended and demonstrated clinically significant pre-post reductions in stress, depressive symptoms, and improved eating behaviors.","['pregnant women', 'Overweight Pregnant Women', 'Methods Forty-six overweight/obese low-income women']","['Mindful Moms Training (MMT', 'MMT', 'EBT', 'Emotional Brain Training (EBT']","['experiential avoidance', 'excessive caloric intake and gestational weight gain', 'stress and depressive symptoms', 'eating behaviors', 'stress, depressive symptoms, and improved eating behaviors', 'Stress and Overeating']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0046370', 'cui_str': 'MMT'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",46.0,0.0333542,"Both interventions were well attended and demonstrated clinically significant pre-post reductions in stress, depressive symptoms, and improved eating behaviors.","[{'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Laraia', 'Affiliation': 'Public Health Nutrition, School of Public Health, University of California, Berkeley, 207-B University Hall, #7360, Berkeley, CA, 94720-7360, USA. blaraia@berkeley.edu.'}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Adler', 'Affiliation': 'Department of Psychiatry, UCSF School of Medicine, 3333 Calif. St, Laurel Heights, San Francisco, CA, 94118, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Coleman-Phox', 'Affiliation': 'Center for Health and Community, 3333 Calif. St, Laurel Heights, San Francisco, CA, 94118, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Vieten', 'Affiliation': 'Institute of Noetic Sciences, 101 San Antonio Road, Petaluma, CA, 94952, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mellin', 'Affiliation': 'Family & Community Medicine and Pediatrics, San Francisco, CA, USA.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Kristeller', 'Affiliation': 'Department of Psychology, Indiana State, Root Hall, B-216, Terre Haute, IN, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychiatry, UCSF School of Medicine, 3333 Calif. St, Laurel Heights, San Francisco, CA, 94118, USA.'}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Stotland', 'Affiliation': 'Department of Ob/Gyn, Reproductive Sciences, San Francisco General Hospital, UCSF School of Medicine, San Francisco, CA, USA.'}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Lustig', 'Affiliation': 'Department of Pediatrics, UCSF School of Medicine, 550 16th Street, 4th Fl., San Francisco, CA, 94143, USA.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Dallman', 'Affiliation': 'UCSF Department of Physiology, San Francisco, CA, USA.'}, {'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'Hecht', 'Affiliation': 'Osher Center for Integrative Medicine, San Francisco, CA, USA.'}, {'ForeName': 'N R', 'Initials': 'NR', 'LastName': 'Bush', 'Affiliation': 'Department of Psychiatry, UCSF School of Medicine, 3333 Calif. St, Laurel Heights, San Francisco, CA, 94118, USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'de Groat', 'Affiliation': 'Center for Health and Community, 3333 Calif. St, Laurel Heights, San Francisco, CA, 94118, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Epel', 'Affiliation': 'Department of Psychiatry, UCSF School of Medicine, 3333 Calif. St, Laurel Heights, San Francisco, CA, 94118, USA.'}]",Maternal and child health journal,['10.1007/s10995-018-2435-z']
622,31860360,Detecting Feigning in Adolescents on the Personality Assessment Inventory-Adolescent Form.,"Much of the research on identifying feigning in psychological assessment has focused on adults with less attention to adolescents. The purpose of the present study is to expand the limited literature on detecting feigning in adolescents using the Personality Assessment Inventory - Adolescent. The study included 114 nonclinical adolescents (ages 15 to 18) recruited from high schools in the Midwest who were randomly assigned to experimental groups: honest nonclinical, uncoached feigning, and coached feigning. 50 randomly selected individuals with depression from the PAI-A clinical standardization sample were included as the honest clinical group. Sample demographics included a mean age of 16.64 years; 51.2% young men, 48.2% young women; 85.4% Caucasian, 6.7% African American, 5.5% Hispanic, and 2.4% Asian. 80% of feigning profiles reported clinical levels of depression. MANOVA results showed strong support for the Rogers Discriminant Function (RDF;  d  range = 1.85-2.05). The Negative Impression Management (NIM) scale also demonstrated promise ( d  range = 0.77-1.08), while the smallest effects for detecting feigning were found for the Malingering Index ( d  range = 0.58-0.70). The negative distortion indices showed good utility in differentiating between groups. Cut-scores and pragmatic implications are presented.",2020,"The Negative Impression Management (NIM) scale also demonstrated promise ( d  range = 0.77-1.08), while the smallest effects for detecting feigning were found for the Malingering Index ( d  range = 0.58-0.70).","['adolescents using the Personality Assessment Inventory - Adolescent', 'Sample demographics included a mean age of 16.64\u2009years; 51.2% young men, 48.2% young women; 85.4% Caucasian, 6.7% African American, 5.5% Hispanic, and 2.4% Asian', '50 randomly selected individuals with depression from the PAI-A clinical standardization sample were included as the honest clinical group', 'Adolescents on the Personality Assessment Inventory-Adolescent Form', '114 nonclinical adolescents (ages 15 to 18) recruited from high schools in the Midwest who were randomly assigned to experimental groups', 'adults with less attention to adolescents']","['honest nonclinical, uncoached feigning, and coached feigning']","['Negative Impression Management (NIM) scale', 'clinical levels of depression']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0031209', 'cui_str': 'Personality Assessment'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0038136', 'cui_str': 'Standardization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",50.0,0.0215101,"The Negative Impression Management (NIM) scale also demonstrated promise ( d  range = 0.77-1.08), while the smallest effects for detecting feigning were found for the Malingering Index ( d  range = 0.58-0.70).","[{'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Malm', 'Affiliation': 'Peotone Community Unit School District 207-U, Peotone, IL, USA.'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Pierson', 'Affiliation': 'Department of Educational Psychology, Ball State University, Muncie, IN, USA.'}, {'ForeName': 'W Holmes', 'Initials': 'WH', 'LastName': 'Finch', 'Affiliation': 'Department of Educational Psychology, Ball State University, Muncie, IN, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Spengler', 'Affiliation': 'Department of Educational Psychology, Ball State University, Muncie, IN, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'Department of Educational Psychology, Ball State University, Muncie, IN, USA.'}, {'ForeName': 'Leslie C', 'Initials': 'LC', 'LastName': 'Morey', 'Affiliation': 'Department of Psychological & Brain Sciences, Texas A&M University, College Station, TX, USA.'}]",Journal of personality assessment,['10.1080/00223891.2019.1693389']
623,31932699,Effects of different aerobic exercise programs on cardiac autonomic modulation and hemodynamics in hypertension: data from EXERDIET-HTA randomized trial.,"The aims of the present study were to analyze the effects of 16 weeks of different aerobic exercise training (ExT) programs with diet on cardiac autonomic modulation and hemodynamics in nonphysically active and overweight/obese adults (n = 249, 53.7 ± 8.0 years) with primary hypertension, and the possible differences among ExT programs and their effects on heart rate (HR), blood pressure (BP), and long-term BP variability (BPV). Participants were randomly assigned into an attention control (AC) group (physical activity recommendations) or one of three supervised ExT groups: high volume of moderate-intensity continuous training, high-volume and high-intensity interval training (HIIT), and low-volume-HIIT. Twenty-four hours of ambulatory BP monitoring was used to analyze systolic (SBP) and diastolic (DBP) BP, HR, and BPV. A cardiopulmonary exercise test was performed to determine peak oxygen uptake (VO 2peak ). Following intervention, resting and submaximal exercise (HR, SBP, and DBP), along with diurnal and nocturnal SBP and DBP values decreased (P < 0.05) in all groups with no differences between groups. When the ExT groups were combined, submaximal SBP (P = 0.048) and DBP (P = 0.004), VO 2peak  (P = 0.014) and HR reserve (P = 0.030) were significantly improved compared with AC. Intervention did not have significant effects on BPV. In the present study better improvements in the autonomic nervous system were seen when the aerobic ExT was individually designed and supervised with pari passu effects irrespective of exercise intensity and volume. Low-volume-HIIT ExT combined with a healthy diet should be considered as a time efficient and safe mechanism for reducing the cardiovascular risk in hypertensive individuals.",2020,VO 2peak  (P = 0.014) and HR reserve (P = 0.030) were significantly improved compared with AC.,"['hypertension', 'nonphysically active and overweight/obese adults (n\u2009=\u2009249, 53.7\u2009±\u20098.0 years) with primary hypertension', 'hypertensive individuals']","['aerobic exercise training (ExT) programs with diet', 'aerobic exercise programs', 'attention control (AC) group (physical activity recommendations) or one of three supervised ExT groups: high volume of moderate-intensity continuous training, high-volume and high-intensity interval training (HIIT), and low-volume-HIIT']","['HR reserve', 'BPV', 'systolic (SBP) and diastolic (DBP) BP, HR, and BPV', 'resting and submaximal exercise (HR, SBP, and DBP), along with diurnal and nocturnal SBP and DBP values', 'VO 2peak', 'peak oxygen uptake (VO 2peak ', 'cardiac autonomic modulation and hemodynamics', 'heart rate (HR), blood pressure (BP), and long-term BP variability (BPV']","[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",,0.0235443,VO 2peak  (P = 0.014) and HR reserve (P = 0.030) were significantly improved compared with AC.,"[{'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'MartinezAguirre-Betolaza', 'Affiliation': 'Department of Physical Education and Sport. Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Mujika', 'Affiliation': 'Department of Physiology. Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa, Basque Country, Spain.'}, {'ForeName': 'Simon M', 'Initials': 'SM', 'LastName': 'Fryer', 'Affiliation': 'University of Gloucestershire, School of Sport and Exercise. Oxstalls Campus, Gloucester, GL2 9HW, UK.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Corres', 'Affiliation': 'Department of Physical Education and Sport. Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Ilargi', 'Initials': 'I', 'LastName': 'Gorostegi-Anduaga', 'Affiliation': 'Department of Physical Education and Sport. Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Iñaki', 'Initials': 'I', 'LastName': 'Arratibel-Imaz', 'Affiliation': 'Department of Physical Education and Sport. Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Pérez-Asenjo', 'Affiliation': 'Cardiology Unit. Igualatorio Médico Quirúrgico (IMQ-Amárica), Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Maldonado-Martín', 'Affiliation': 'Department of Physical Education and Sport. Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain. sara.maldonado@ehu.eus.'}]",Journal of human hypertension,['10.1038/s41371-020-0298-4']
624,31608373,The Effect of Community-Based Nutritional Interventions on Children of Women Living With Human Immunodeficiency Virus in Rural India: A 2 × 2 Factorial Intervention Trial.,"BACKGROUND


Malnutrition is a common clinical concern among children in low-income communities affected by human immunodeficiency virus (HIV). We examined the effect of a community-based nutritional intervention on anthropometric and clinical outcomes of children of women living with HIV in rural India.
METHODS


We assigned women living with HIV and their child (oldest 3-8 years) to 1 of 4 programs: (1) community-based HIV care program, (2) program 1 + nutrition education, (3) program 1 + food supplement, and (4) all elements of programs 1-3. Study data were collected at baseline and months 6, 12, and 18. We applied mixed-effects modeling with restricted maximum likelihood estimation to examine changes in weight (all children) and CD4+ T-cell counts (children with HIV only).
RESULTS


Overall, 600 mother-child pairs were enrolled (150/group) with 100% retention at follow-up visits. Approximately 20% of children were living with HIV. Children in program 4 had higher weight gain than those in programs 1, 2, and 3 at all time points (adjusted P < .001). We found a higher increase in CD4+ T cells across all time points among participants in programs 3 and 4 compared with program 1 (adjusted P < .001). Factorial analysis suggested a synergistic effect of combining nutrition education and food supplements for weight gain but not for increase in CD4+ T cells.
CONCLUSIONS


A combination of nutrition education and food supplements provided to women living with HIV significantly increased weight and CD4+ T cells, and such interventions can be integrated into HIV-care programs in low-income settings.",2020,"Children in Program 4 had higher weight gain compared to Programs 1, 2 and 3 at all time points (adjusted p < 0.001).","['children of women living with HIV in rural India', 'women living with HIV and their child (oldest 3-8 years) to one of the four programs: 1', '600 mother-child pairs were enrolled (150 per group) with 100% retention at follow-up visits', 'women living with HIV']","['community-based nutritional interventions', 'nutrition education and food supplements', 'community-based nutritional intervention', 'community-based HIV care program']","['CD4+ T cells', 'weight and CD4+ T cells', 'weight gain']","[{'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",600.0,0.0719227,"Children in Program 4 had higher weight gain compared to Programs 1, 2 and 3 at all time points (adjusted p < 0.001).","[{'ForeName': 'Sanghyuk S', 'Initials': 'SS', 'LastName': 'Shin', 'Affiliation': 'Sue & Bill Gross School of Nursing, University of California Irvine, Irvine, California, USA.'}, {'ForeName': 'Veena A', 'Initials': 'VA', 'LastName': 'Satyanarayana', 'Affiliation': 'Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Bengaluru, India.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Ekstrand', 'Affiliation': 'University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Carpenter', 'Affiliation': 'Department of Epidemiology, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Sue & Bill Gross School of Nursing, University of California Irvine, Irvine, California, USA.'}, {'ForeName': 'Kartik', 'Initials': 'K', 'LastName': 'Yadav', 'Affiliation': 'Sue & Bill Gross School of Nursing, University of California Irvine, Irvine, California, USA.'}, {'ForeName': 'Padma', 'Initials': 'P', 'LastName': 'Ramakrishnan', 'Affiliation': 'Department of Medicine, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Pamujula', 'Affiliation': 'A.C. Subba Reddy Government Medical College, Nellore, India.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'Department of Medicine, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Adeline M', 'Initials': 'AM', 'LastName': 'Nyamathi', 'Affiliation': 'Sue & Bill Gross School of Nursing, University of California Irvine, Irvine, California, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1009']
625,31523892,"Safety and efficacy of the partial adenosine A1 receptor agonist neladenoson bialanate in patients with chronic heart failure with reduced ejection fraction: a phase IIb, randomized, double-blind, placebo-controlled trial.","AIMS


Neladenoson bialanate is a partial adenosine A1 receptor agonist with demonstrated beneficial effects on cardiac function in animal models. We aimed to assess the dose-response effect of neladenoson bialanate on cardiac structure and function, clinical outcome, and safety in patients with heart failure (HF) with reduced ejection fraction (HFrEF).
METHODS AND RESULTS


PANTHEON was a dose-finding, phase IIb, randomized, double-blind, placebo-controlled trial conducted in 92 centres in 11 countries including 462 patients with chronic HFrEF, randomized to once daily oral dose of neladenoson bialanate (5, 10, 20, 30, and 40 mg) or placebo. The primary endpoints were change from baseline to 20 weeks in left ventricular ejection fraction (LVEF) (echocardiography) and in N-terminal pro-B-type natriuretic peptide (NT-proBNP). Mean age of the patients was 67 years, 17% were female, mean LVEF was 28%, mean NT-proBNP was 2085 ng/L. After 20 weeks of treatment, there was no dose-effect of neladenoson bialanate on changes in NT-proBNP or LVEF (primary endpoints). No effect of neladenoson bialanate was found on left ventricular volumes, high-sensitivity troponin T, or cardiovascular mortality, HF hospitalization, and urgent visits for HF (secondary endpoints). There was a dose-dependent increase in creatinine and cystatin C, and a dose-dependent decrease in estimated glomerular filtration rate and heart rate.
CONCLUSIONS


In patients with chronic HFrEF, treatment with neladenoson bialanate was not associated with dose-dependent favourable effects on cardiac structure and function, cardiac risk markers, or clinical outcome but was associated with a dose-dependent decrease in renal function.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT02992288.",2019,"No effect of neladenoson bialanate was found on left ventricular volumes, high-sensitivity troponin T, or cardiovascular mortality, HF hospitalization, and urgent visits for HF (secondary endpoints).","['92 centres in 11 countries including 462 patients with chronic HFrEF', 'patients with heart failure (HF) with reduced ejection fraction (HFrEF', 'patients with chronic heart failure with reduced ejection fraction', 'Mean age of the patients was 67\u2009years, 17% were female, mean LVEF was 28%, mean NT-proBNP was 2085']","['placebo', 'neladenoson bialanate', 'partial adenosine A1 receptor agonist neladenoson bialanate']","['creatinine and cystatin C', 'Safety and efficacy', 'left ventricular volumes, high-sensitivity troponin T, or cardiovascular mortality, HF hospitalization, and urgent visits for HF (secondary endpoints', 'cardiac structure and function, clinical outcome, and safety', 'renal function', 'estimated glomerular filtration rate and heart rate', 'change from baseline to 20\u2009weeks in left ventricular ejection fraction (LVEF) (echocardiography) and in N-terminal pro-B-type natriuretic peptide (NT-proBNP', 'cardiac structure and function, cardiac risk markers']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4519331', 'cui_str': 'neladenoson bialanate'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C2936550', 'cui_str': 'Adenosine A1 Receptor Agonists'}]","[{'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C3811844'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",462.0,0.557535,"No effect of neladenoson bialanate was found on left ventricular volumes, high-sensitivity troponin T, or cardiovascular mortality, HF hospitalization, and urgent visits for HF (secondary endpoints).","[{'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jeroen J', 'Initials': 'JJ', 'LastName': 'Bax', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Antonieta B', 'Initials': 'AB', 'LastName': 'Wirtz', 'Affiliation': 'Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Akos F', 'Initials': 'AF', 'LastName': 'Pap', 'Affiliation': 'Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Ferreira', 'Affiliation': 'Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'van der Laan', 'Affiliation': 'Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1591']
626,31487546,Community Health Workers Improve Linkage to Hypertension Care in Western Kenya.,"BACKGROUND


Elevated blood pressure (BP) is the leading global risk factor for mortality. Delay in seeking hypertension care is associated with increased mortality.
OBJECTIVES


This study investigated whether community health workers, equipped with behavioral communication strategies and smartphone technology, can increase linkage of individuals with elevated BP to a hypertension care program in western Kenya and significantly reduce BP.
METHODS


The study was a cluster randomized trial with 3 arms: 1) usual care (standard training); 2) ""paper-based"" (tailored behavioral communication, using paper-based tools); and 3) ""smartphone"" (tailored behavioral communication, using smartphone technology). The co-primary outcomes were: 1) linkage to care; and 2) change in systolic BP (SBP). A covariate-adjusted mixed-effects model was used, adjusting for differential time to follow-up. Bootstrap and multiple imputation were used to handle missing data.
RESULTS


A total of 1,460 individuals (58% women) were enrolled (491 usual care, 500 paper-based, 469 smartphone). Average baseline SBP was 159.4 mm Hg. Follow-up measures of linkage were available for 1,128 (77%) and BP for 1,106 (76%). Linkage to care was 49% overall, with significantly greater linkage in the usual care and smartphone arms of the trial. Average overall follow-up SBP was 149.9 mm Hg. Participants in the smartphone arm experienced a modestly greater reduction in SBP versus usual care (-13.1 mm Hg vs. -9.7 mm Hg), but this difference was not statistically significant. Mediation analysis revealed that linkage to care contributed to SBP change.
CONCLUSIONS


A strategy combining tailored behavioral communication and mobile health (mHealth) for community health workers led to improved linkage to care, but not statistically significant improvement in SBP reduction. Further innovations to improve hypertension control are needed. (Optimizing Linkage and Retention to Hypertension Care in Rural Kenya [LARK]; NCT01844596).",2019,"Participants in the smartphone arm experienced a modestly greater reduction in SBP vs. usual care (-13.1 mmHg vs. -9.7), but this difference was not statistically significant.","['individuals with elevated BP to a hypertension care program in western Kenya and significantly reduce BP', 'Community Health Workers Improve Linkage to Hypertension Care in Western Kenya', '1460 individuals (58% women) were enrolled (491 usual care, 500 paper-based, 469 smartphone', 'community health workers']","['usual care (standard training); 2) ""paper-based"" (tailored behavioral communication, using paper-based tools); and 3) ""smartphone"" (tailored behavioral communication, using smartphone technology']","['SBP reduction', 'SBP vs. usual care', '1) linkage to care, and 2) change in systolic BP (SBP']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",469.0,0.0333161,"Participants in the smartphone arm experienced a modestly greater reduction in SBP vs. usual care (-13.1 mmHg vs. -9.7), but this difference was not statistically significant.","[{'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Vedanthan', 'Affiliation': 'New York University School of Medicine, New York, New York. Electronic address: rajesh.vedanthan@nyulangone.org.'}, {'ForeName': 'Jemima H', 'Initials': 'JH', 'LastName': 'Kamano', 'Affiliation': 'Moi University College of Health Sciences, Eldoret, Kenya.'}, {'ForeName': 'Allison K', 'Initials': 'AK', 'LastName': 'DeLong', 'Affiliation': 'School of Public Health, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Violet', 'Initials': 'V', 'LastName': 'Naanyu', 'Affiliation': 'Moi University College of Health Sciences, Eldoret, Kenya.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Binanay', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Gerald S', 'Initials': 'GS', 'LastName': 'Bloomfield', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Stavroula A', 'Initials': 'SA', 'LastName': 'Chrysanthopoulou', 'Affiliation': 'School of Public Health, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Hogan', 'Affiliation': 'School of Public Health, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Carol R', 'Initials': 'CR', 'LastName': 'Horowitz', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Inui', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Menya', 'Affiliation': 'Moi University College of Health Sciences, Eldoret, Kenya.'}, {'ForeName': 'Vitalis', 'Initials': 'V', 'LastName': 'Orango', 'Affiliation': 'Academic Model Providing Access to Healthcare, Eldoret, Kenya.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Martin C', 'Initials': 'MC', 'LastName': 'Were', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Sylvester', 'Initials': 'S', 'LastName': 'Kimaiyo', 'Affiliation': 'Moi University College of Health Sciences, Eldoret, Kenya.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.08.003']
627,30786186,Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer.,"BACKGROUND


Ambulatory patients receiving systemic cancer therapy are at varying risk for venous thromboembolism. However, the benefit of thromboprophylaxis in these patients is uncertain.
METHODS


In this double-blind, randomized trial involving high-risk ambulatory patients with cancer (Khorana score of ≥2, on a scale from 0 to 6, with higher scores indicating a higher risk of venous thromboembolism), we randomly assigned patients without deep-vein thrombosis at screening to receive rivaroxaban (at a dose of 10 mg) or placebo daily for up to 180 days, with screening every 8 weeks. The primary efficacy end point was a composite of objectively confirmed proximal deep-vein thrombosis in a lower limb, pulmonary embolism, symptomatic deep-vein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, and death from venous thromboembolism and was assessed up to day 180. In a prespecified supportive analysis involving the same population, the same end point was assessed during the intervention period (first receipt of trial agent to last dose plus 2 days). The primary safety end point was major bleeding.
RESULTS


Of 1080 enrolled patients, 49 (4.5%) had thrombosis at screening and did not undergo randomization. Of the 841 patients who underwent randomization, the primary end point occurred in 25 of 420 patients (6.0%) in the rivaroxaban group and in 37 of 421 (8.8%) in the placebo group (hazard ratio, 0.66; 95% confidence interval [CI], 0.40 to 1.09; P = 0.10) in the period up to day 180. In the prespecified intervention-period analysis, the primary end point occurred in 11 patients (2.6%) in the rivaroxaban group and in 27 (6.4%) in the placebo group (hazard ratio, 0.40; 95% CI, 0.20 to 0.80). Major bleeding occurred in 8 of 405 patients (2.0%) in the rivaroxaban group and in 4 of 404 (1.0%) in the placebo group (hazard ratio, 1.96; 95% CI, 0.59 to 6.49).
CONCLUSIONS


In high-risk ambulatory patients with cancer, treatment with rivaroxaban did not result in a significantly lower incidence of venous thromboembolism or death due to venous thromboembolism in the 180-day trial period. During the intervention period, rivaroxaban led to a substantially lower incidence of such events, with a low incidence of major bleeding. (Funded by Janssen and others; CASSINI ClinicalTrials.gov number, NCT02555878.).",2019,"The primary efficacy end point was a composite of objectively confirmed proximal deep-vein thrombosis in a lower limb, pulmonary embolism, symptomatic deep-vein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, and death from venous thromboembolism and was assessed up to day 180.","['high-risk ambulatory patients with cancer (Khorana score of ≥2, on a scale from 0 to 6, with higher scores indicating a higher risk of venous thromboembolism', 'High-Risk Ambulatory Patients with Cancer', '1080 enrolled patients, 49 (4.5%) had thrombosis at screening and did not undergo randomization', 'high-risk ambulatory patients with cancer', 'Ambulatory patients receiving']","['rivaroxaban', 'systemic cancer therapy', 'placebo', 'Rivaroxaban']","['Major bleeding', 'major bleeding', 'composite of objectively confirmed proximal deep-vein thrombosis in a lower limb, pulmonary embolism, symptomatic deep-vein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, and death from venous thromboembolism', 'venous thromboembolism or death']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}]",1080.0,0.530441,"The primary efficacy end point was a composite of objectively confirmed proximal deep-vein thrombosis in a lower limb, pulmonary embolism, symptomatic deep-vein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, and death from venous thromboembolism and was assessed up to day 180.","[{'ForeName': 'Alok A', 'Initials': 'AA', 'LastName': 'Khorana', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Gerald A', 'Initials': 'GA', 'LastName': 'Soff', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Kakkar', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Saroj', 'Initials': 'S', 'LastName': 'Vadhan-Raj', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Riess', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Wun', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Streiff', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Garcia', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Howard A', 'Initials': 'HA', 'LastName': 'Liebman', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Chandra P', 'Initials': 'CP', 'LastName': 'Belani', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Jai N', 'Initials': 'JN', 'LastName': 'Patel', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Habte A', 'Initials': 'HA', 'LastName': 'Yimer', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wildgoose', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Burton', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Ujjwala', 'Initials': 'U', 'LastName': 'Vijapurkar', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Simrati', 'Initials': 'S', 'LastName': 'Kaul', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Eikelboom', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McBane', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Bauer', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Kuderer', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Gary H', 'Initials': 'GH', 'LastName': 'Lyman', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1814630']
628,29512972,Efficacy of a cosmetic phyto-caffeine shampoo in female androgenetic alopecia.,"BACKGROUND


Androgenetic alopecia (AGA) is the most common type of hair loss in both males as well as females, occurring in up to 57% of women by the age of 80 years. Androgenetic alopecia is associated with a high psychological burden and often results in substantially reduced quality of life, poor body image and low self-esteem, particularly in women. Caffeine-based products have shown promise, both in vitro and in vivo, as potential treatments for AGA. This study was performed to determine the efficacy of a phyto-caffeine-containing shampoo used over a 6-month period in female subjects with AGA.
METHODS


This was a single-center, double-blind parallel trial in which female subjects with AGA were randomized to either a phyto-caffeine-containing shampoo or a control shampoo. The primary endpoint was the change from baseline in the number of hairs pulled in a hair pull test at 6 months. Hair loss intensity, hair strength, subject satisfaction and tolerability were also assessed.
RESULTS


Subjects using the phyto-caffeine-containing shampoo had significantly fewer hairs pulled in a hair pull test at 6 months, compared with subjects using the control shampoo (-3.1 vs. -0.5 hairs; P<0.001). The majority of pre-specified secondary endpoints were also significantly improved for subjects using the phyto-caffeine-containing shampoo, compared with controls. Both products were very well tolerated.
CONCLUSIONS


Compared with a control shampoo, a phyto-caffeine-containing shampoo was more efficacious, with respect to the number of hairs being pulled out at 6 months, hair loss intensity and hair strength in subjects with AGA.",2020,"RESULTS


Subjects using the phyto-caffeine-containing shampoo had significantly fewer hairs pulled in a hair pull test at 6 months, compared with subjects using the control shampoo (-3.1 vs -0.5 hairs; p<0.001).","['female subjects with AGA', 'female androgenetic alopecia', 'males as well as females, occurring in up to 57% of women by the age of 80 years', 'subjects with AGA']","['control shampoo, a phyto-caffeine-containing shampoo', 'phyto-caffeine- containing shampoo', 'Caffeine', 'phyto-caffeine-containing shampoo or a control shampoo', 'cosmetic phyto-caffeine shampoo']","['quality of life, poor body image and low self-esteem', 'tolerated', 'number of hairs pulled in a hair pull test', 'Hair loss intensity, hair strength, subject satisfaction and tolerability', 'hair pull test']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0162311', 'cui_str': 'Pattern Baldness'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1554936', 'cui_str': 'Shampoo - dosing instruction imperative'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C2732632', 'cui_str': 'Poor body image'}, {'cui': 'C0679136', 'cui_str': 'Low self-esteem (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0580846', 'cui_str': 'Does pull (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0529652,"RESULTS


Subjects using the phyto-caffeine-containing shampoo had significantly fewer hairs pulled in a hair pull test at 6 months, compared with subjects using the control shampoo (-3.1 vs -0.5 hairs; p<0.001).","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Bussoletti', 'Affiliation': 'Research Center for Biotechnology Applied to Cosmetology, Sacred Heart Catholic University, Rome, Italy.'}, {'ForeName': 'Maria V', 'Initials': 'MV', 'LastName': 'Tolaini', 'Affiliation': 'Product Testing Department, Eurofins Biopharma, Rome, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Celleno', 'Affiliation': 'Research Center for Biotechnology Applied to Cosmetology, Sacred Heart Catholic University, Rome, Italy - lcelleno@libero.it.'}]","Giornale italiano di dermatologia e venereologia : organo ufficiale, Societa italiana di dermatologia e sifilografia",['10.23736/S0392-0488.18.05499-8']
629,29456507,"The Effects of Vitamin D Supplementation on Signaling Pathway of Inflammation and Oxidative Stress in Diabetic Hemodialysis: A Randomized, Double-Blind, Placebo-Controlled Trial.","Objective:  This study was carried out to determine the effects of vitamin D supplementation on signaling pathway of inflammation and oxidative stress in diabetic hemodialysis (HD) patients.  Methods:  This randomized double-blind placebo-controlled clinical trial was conducted among 60 diabetic HD patients. Subjects were randomly allocated into two groups to intake either vitamin D supplements at a dosage of 50,000 IU ( n  = 30) or placebo ( n  = 30) every 2 weeks for 12 weeks. Gene expression of inflammatory cytokines and biomarkers of oxidative stress were assessed in peripheral blood mononuclear cells (PBMCs) of diabetic HD patients with RT-PCR method.  Results:  Results of RT-PCR indicated that after the 12-week intervention, compared to the placebo, vitamin D supplementation downregulated gene expression of interleukin (IL)-1β ( P  = 0.02), tumor necrosis factor alpha (TNF-α) ( P  = 0.02) and interferon gamma (IFN-γ) ( P  = 0.03) in PBMCs of diabetic HD patients. Additionally, vitamin D supplementation, compared to the placebo, downregulated gene expression of transforming growth factor beta (TGF-β) ( P  = 0.04), protein kinase C (PKC) ( P  = 0.001), and mitogen-activated protein kinases 1 (MAPK1) ( P  = 0.02) in PBMCs of diabetic HD patients. Although not significant, vitamin D supplementation let to a reduction of nuclear factor kappa B (NF-kB) ( p  = 0.75) expression in PBMCs isolated from diabetic patients compared to the placebo group. There was no statistically significant change following supplementation with vitamin D on gene expression of interleukin (IL)-4, IL-6, and vascular endothelial growth factor (VEGF) in PBMCs of diabetic HD patients.  Conclusions:  Overall, we found that vitamin D supplementation for 12 weeks among diabetic HD patients had beneficial effects on few gene expression related to inflammation and oxidative stress.  Clinical trial registration:  IRCT201701035623N101. Registered on January 8, 2017.",2018,"Although not significant, vitamin D supplementation let to a reduction of nuclear factor kappa B","['diabetic HD patients with RT-PCR method', '60 diabetic HD patients', 'diabetic HD patients', 'Diabetic Hemodialysis', 'diabetic hemodialysis (HD) patients']","['vitamin D', 'vitamin D supplementation', 'placebo', 'Placebo', 'Vitamin D Supplementation', 'placebo, vitamin D supplementation', 'RT-PCR', 'vitamin D supplements']","['protein kinase C (PKC', 'nuclear factor kappa B', 'gene expression of interleukin (IL)-4, IL-6, and vascular endothelial growth factor (VEGF', 'tumor necrosis factor alpha (TNF-α', 'Signaling Pathway of Inflammation and Oxidative Stress', 'gene expression of interleukin (IL)-1β', 'mitogen-activated protein kinases 1 (MAPK1', 'peripheral blood mononuclear cells (PBMCs', 'Gene expression of inflammatory cytokines and biomarkers of oxidative stress', 'signaling pathway of inflammation and oxidative stress', 'interferon gamma (IFN-γ', 'gene expression of transforming growth factor beta (TGF-β']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}]","[{'cui': 'C0256371', 'cui_str': 'PKC-alpha Serine-Threonine Kinase'}, {'cui': 'C0256015', 'cui_str': 'PRKCG'}, {'cui': 'C0079904', 'cui_str': 'Nuclear Factor-Kappab'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0037080', 'cui_str': 'Signal Pathways'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0170168', 'cui_str': 'Mitogen-Activated Protein Kinase 2'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021745', 'cui_str': 'interferon gamma'}, {'cui': 'C0040690', 'cui_str': 'Bone-Derived Transforming Growth Factor'}]",60.0,0.3447,"Although not significant, vitamin D supplementation let to a reduction of nuclear factor kappa B","[{'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Haddad Kashani', 'Affiliation': 'Anatomical Sciences Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Seyed Hosseini', 'Affiliation': 'Anatomical Sciences Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Nikzad', 'Affiliation': 'Anatomical Sciences Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Soleimani', 'Affiliation': 'Department of Internal Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Soleimani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Tamadon', 'Affiliation': 'Department of Internal Medicine, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Keneshlou', 'Affiliation': 'Department of Urology, School of Medicine, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}]",Frontiers in pharmacology,['10.3389/fphar.2018.00050']
630,31618099,Entitled Due to Deprivation vs. Superiority: Evidence That Unidimensional Entitlement Scales Blend Distinct Entitlement Rationales across Psychological Dimensions.,"We aimed to corroborate the notion that the Psychological Entitlement Scale (PES), a popular unidimensional index of psychological entitlement, resembles a blend of vulnerable- and grandiose-based entitlement rationales across various psychological dimensions. College participants ( N  = 523) were randomly assigned to complete either the PES or a recently validated, multidimensional adaptation of the PES that purports to assess entitlement due to deprivation (vulnerable-based entitlement; ""PES-V"") and superiority (grandiose-based entitlement; ""PES-G"") claims. Participants then completed a battery of psychological dimensions including: narcissism constructs, interpersonal vulnerability and mood pathology, psychological health, normal personality and personality-disorder traits, motivation systems, a deprived identity, and status aspiration. Profile-similarity indices indicated that PES was more similar to PES-G than PES-V across psychological dimensions. Likewise, additional analyses revealed that indicators of ""narcissistic entitlement"" exhibited stronger profile similarity to PES-G than PES-V across psychological dimensions. In conclusion, profiles of the PES and narcissistic entitlement appear to blend grandiose- and vulnerable-based entitlement, but grandiose-based (vs. vulnerable-based) entitlement seems more prominent in the blend. As a result, unidimensional measures can create a somewhat misleading portrait of the psychologically entitled.",2020,Profile-similarity indices indicated that PES was more similar to PES-G than PES-V across psychological dimensions.,['College participants ( N \u2009=\u2009523'],"['PES or a recently validated, multidimensional adaptation of the PES that purports to assess entitlement due to deprivation (vulnerable-based entitlement; ""PES-V"") and superiority (grandiose-based entitlement; ""PES-G"") claims']","['Psychological Entitlement Scale (PES', 'narcissism constructs, interpersonal vulnerability and mood pathology, psychological health, normal personality and personality-disorder traits, motivation systems, a deprived identity, and status aspiration']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0027401', 'cui_str': 'Narcissism'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0031208', 'cui_str': 'Personality'}, {'cui': 'C0031212', 'cui_str': 'Personality Disorders'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}]",523.0,0.02893,Profile-similarity indices indicated that PES was more similar to PES-G than PES-V across psychological dimensions.,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hart', 'Affiliation': 'Department of Psychology, University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Tortoriello', 'Affiliation': 'Department of Psychology, University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Breeden', 'Affiliation': 'Department of Psychology, University of Alabama, Tuscaloosa, Alabama, USA.'}]",Journal of personality assessment,['10.1080/00223891.2019.1674319']
631,29565423,Short-term costs of integrating whole-genome sequencing into primary care and cardiology settings: a pilot randomized trial.,"PURPOSE


Great uncertainty exists about the costs associated with whole-genome sequencing (WGS).
METHODS


One hundred cardiology patients with cardiomyopathy diagnoses and 100 ostensibly healthy primary care patients were randomized to receive a family-history report alone or with a WGS report. Cardiology patients also reviewed prior genetic test results. WGS costs were estimated by tracking resource use and staff time. Downstream costs were estimated by identifying services in administrative data, medical records, and patient surveys for 6 months.
RESULTS


The incremental cost per patient of WGS testing was $5,098 in cardiology settings and $5,073 in primary care settings compared with family history alone. Mean 6-month downstream costs did not differ statistically between the control and WGS arms in either setting (cardiology: difference = -$1,560, 95% confidence interval -$7,558 to $3,866, p = 0.36; primary care: difference = $681, 95% confidence interval -$884 to $2,171, p = 0.70). Scenario analyses showed the cost reduction of omitting or limiting the types of secondary findings was less than $69 and $182 per patient in cardiology and primary care, respectively.
CONCLUSION


Short-term costs of WGS were driven by the costs of sequencing and interpretation rather than downstream health care. Disclosing additional types of secondary findings has a limited cost impact following disclosure.",2018,Mean 6-month downstream costs did not differ statistically between the control and WGS arms in either setting (cardiology: difference = ,['One hundred cardiology patients with cardiomyopathy diagnoses and 100 ostensibly healthy primary care patients'],['family-history report alone or with a WGS report'],"['Downstream costs', 'Mean 6-month downstream costs', 'WGS costs']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0522506', 'cui_str': 'Downstream (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",100.0,0.0633022,Mean 6-month downstream costs did not differ statistically between the control and WGS arms in either setting (cardiology: difference = ,"[{'ForeName': 'Kurt D', 'Initials': 'KD', 'LastName': 'Christensen', 'Affiliation': ""Division of Genetics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA. kchristensen@bwh.harvard.edu.""}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Vassy', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Phillips', 'Affiliation': 'Department of Clinical Pharmacy, Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Carrie L', 'Initials': 'CL', 'LastName': 'Blout', 'Affiliation': ""Division of Genetics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Danielle R', 'Initials': 'DR', 'LastName': 'Azzariti', 'Affiliation': 'Partners HealthCare Laboratory for Molecular Medicine, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Christine Y', 'Initials': 'CY', 'LastName': 'Lu', 'Affiliation': 'Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Jill O', 'Initials': 'JO', 'LastName': 'Robinson', 'Affiliation': 'Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Douglas', 'Affiliation': 'Department of Clinical Pharmacy, Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Yeh', 'Affiliation': 'Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kalotina', 'Initials': 'K', 'LastName': 'Machini', 'Affiliation': 'Partners HealthCare Laboratory for Molecular Medicine, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Natasha K', 'Initials': 'NK', 'LastName': 'Stout', 'Affiliation': 'Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Heidi L', 'Initials': 'HL', 'LastName': 'Rehm', 'Affiliation': 'Partners HealthCare Laboratory for Molecular Medicine, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'McGuire', 'Affiliation': 'Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Green', 'Affiliation': ""Division of Genetics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Dukhovny', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/gim.2018.35']
632,31596213,Clinical- and Cost-Effectiveness of a Mandibular Advancement Device Versus Continuous Positive Airway Pressure in Moderate Obstructive Sleep Apnea.,"STUDY OBJECTIVES


Limited evidence exists on the cost-effectiveness of mandibular advancement device (MAD) compared to continuous positive airway pressure (CPAP) therapy in moderate obstructive sleep apnea (OSA). Therefore, this study compares the clinical and cost-effectiveness of MAD therapy with CPAP therapy in moderate OSA.
METHODS


In a multicentre randomized controlled trial, patients with an apnea-hypopnea index (AHI) of 15 to 30 events/h were randomized to either MAD or CPAP. Incremental cost-effectiveness and cost-utility ratios (ICER/ICUR, in terms of AHI reduction and quality-adjusted life-years [QALYs, based on the EuroQol Five-Dimension Quality of Life questionnaire]) were calculated after 12 months, all from a societal perspective.
RESULTS


In the 85 randomized patients (n = 42 CPAP, n = 43 MAD), AHI reduction was significantly greater with CPAP (median reduction AHI 18.3 [14.8-22.6] events/h) than with MAD therapy (median reduction AHI 13.5 [8.5-18.4] events/h) after 12 months. Societal costs after 12 months were higher for MAD than for CPAP (mean difference €2.156). MAD was less cost-effective than CPAP after 12 months (ICER -€305 [-€3.003 to €1.572] per AHI point improvement). However, in terms of QALY, MAD performed better than CPAP after 12 months (€33.701 [-€191.106 to €562.271] per QALY gained).
CONCLUSIONS


CPAP was more clinically effective (in terms of AHI reduction) and cost-effective than MAD. However, costs per QALY was better with MAD as compared to CPAP. Therefore, CPAP is the first-choice treatment option in moderate OSA and MAD may be a good alternative.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Identifier: NCT01588275.",2019,"However, in terms of QALY, MAD performed better than CPAP after 12 months (€33.701 [-€191.106 to €562.271] per QALY gained).
","['patients with an apnea-hypopnea index (AHI) of 15 to 30 events/h', 'moderate obstructive sleep apnea (OSA', 'Moderate Obstructive Sleep Apnea']","['MAD or CPAP', 'Mandibular Advancement Device Versus Continuous Positive Airway Pressure', 'MAD therapy with CPAP therapy', 'mandibular advancement device (MAD', 'CPAP', 'continuous positive airway pressure (CPAP) therapy']","['Incremental cost-effectiveness and cost-utility ratios (ICER/ICUR', 'Societal costs', 'AHI reduction and quality-adjusted life-years [QALYs, based on the EuroQol Five-Dimension Quality of Life questionnaire', 'costs per QALY', 'AHI reduction', 'AHI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0376461', 'cui_str': 'Mandibular Advancement'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",85.0,0.0515504,"However, in terms of QALY, MAD performed better than CPAP after 12 months (€33.701 [-€191.106 to €562.271] per QALY gained).
","[{'ForeName': 'Grietje E', 'Initials': 'GE', 'LastName': 'de Vries', 'Affiliation': 'Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Aarnoud', 'Initials': 'A', 'LastName': 'Hoekema', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Johannes Q P J', 'Initials': 'JQPJ', 'LastName': 'Claessen', 'Affiliation': 'Department of Ear Nose and Throat surgery, Martini Hospital Groningen, The Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Jacobs', 'Affiliation': 'Department of Pulmonary Diseases, Martini Hospital Groningen, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'van der Maten', 'Affiliation': 'Department of Pulmonary Diseases, Medical Center Leeuwarden, The Netherlands.'}, {'ForeName': 'Johannes H', 'Initials': 'JH', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Clinical Neurophysiology, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'Stegenga', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Wijkstra', 'Affiliation': 'Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, The Netherlands.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7980']
633,31285303,Cardiovascular safety of nintedanib in subgroups by cardiovascular risk at baseline in the TOMORROW and INPULSIS trials.,"Nintedanib is a tyrosine kinase inhibitor used to treat idiopathic pulmonary fibrosis (IPF). We investigated the cardiovascular safety of nintedanib using pooled data from the TOMORROW and INPULSIS trials.Cardiovascular events were assessed  post hoc  in patients with a history of atherosclerotic cardiovascular disease (CVD) and/or one or more cardiovascular risk factors at baseline (""higher cardiovascular risk"") and patients with no history of atherosclerotic CVD and no cardiovascular risk factors at baseline (""lower cardiovascular risk"").Incidence rates were calculated for 1231 patients (n=723 nintedanib and n=508 placebo), of whom 89.9% had higher cardiovascular risk. Incidence rates of major adverse cardiovascular events were similar in the nintedanib and placebo groups in patients with higher cardiovascular risk (3.88 (95% CI 2.58-5.84) and 3.49 (95% CI 2.10-5.79) per 100 patient-years, respectively) and lower cardiovascular risk (4.78 (95% CI 1.54-14.82) and 5.37 (95% CI 1.73-16.65) per 100 patient-years, respectively). Incidence rates of myocardial infarction in the nintedanib and placebo groups, respectively, were 3.03 (95% CI 1.91-4.81) and 1.16 (95% CI 0.48-2.79) per 100 patient-years in patients with higher cardiovascular risk and 1.59 (95% CI 0.22-11.29) and 1.78 (95% CI 0.25-12.64) per 100 patient-years in patients with lower cardiovascular risk. Incidence rates of other ischaemic heart disease in the nintedanib and placebo groups, respectively, were 1.85 (95% CI 1.02-3.34) and 3.28 (95% CI 1.94-5.54) per 100 patient-years in patients with higher cardiovascular risk and 0 and 1.80 (95% CI 0.25-12.78) per 100 patient-years in patients with lower cardiovascular risk.These data help to establish the cardiovascular safety profile of nintedanib in IPF.",2019,"Incidence rates of other ischaemic heart disease in the nintedanib and placebo groups, respectively, were 1.85 (95% CI:1.02-3.34) and 3.28 (95% CI:1.94-5.54) per 100 patient-years in patients with higher CV risk and 0 and 1.80 (95% CI:0.25-12.78) per 100 patient-years in patients with lower CV risk.",[],['placebo'],"['atherosclerotic CV disease (CVD) and/or ≥1 CV risk factor', 'CV safety', 'CV risk"").Incidence rates', 'CV risk', 'CV events', 'lower CV risk', 'Incidence rates of other ischaemic heart disease', 'atherosclerotic CVD and no CV risk factors', 'Incidence rates of myocardial infarction', 'Incidence rates of major adverse cardiovascular events', 'cardiovascular (CV) safety']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2609430', 'cui_str': 'Other ischaemic heart disease (SMQ)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.250991,"Incidence rates of other ischaemic heart disease in the nintedanib and placebo groups, respectively, were 1.85 (95% CI:1.02-3.34) and 3.28 (95% CI:1.94-5.54) per 100 patient-years in patients with higher CV risk and 0 and 1.80 (95% CI:0.25-12.78) per 100 patient-years in patients with lower CV risk.","[{'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Noth', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Virginia School of Medicine, Charlottesville, VA, USA IN2C@hscmail.mcc.virginia.edu.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Wijsenbeek', 'Affiliation': 'Dept of Pulmonary Medicine, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kolb', 'Affiliation': 'Dept of Respiratory Medicine, Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bonella', 'Affiliation': 'Interstitial and Rare Lung Disease Unit, Ruhrlandklinik, University Hospital, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Lizette', 'Initials': 'L', 'LastName': 'Moros', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wachtlin', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Tamera J', 'Initials': 'TJ', 'LastName': 'Corte', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, Australia.'}]",The European respiratory journal,['10.1183/13993003.01797-2018']
634,31355924,Follow-up approaches to a health literacy intervention to increase colorectal cancer screening in rural community clinics: A randomized controlled trial.,"BACKGROUND


Significant disparities exist in colorectal cancer (CRC) screening rates among those of low socioeconomic status, with fewer years of education, lacking health insurance, or living in rural areas.
METHODS


A randomized controlled trial was conducted to compare the effectiveness of 2 follow-up approaches to a health literacy intervention to improve CRC screening: automated telephone call or personal call. Patients aged 50 to 75 years residing in 4 rural community clinics in Louisiana were given a structured interview that assessed demographic, health literacy and CRC screening barriers, knowledge, and attitudes. All were given health literacy-informed CRC education, a patient-friendly CRC screening pamphlet, simplified fecal immunochemical test (FIT) instructions, and a FIT kit, and a ""teach-back"" method was used to confirm understanding. Patients were randomized to 1 of 2 telephone follow-up arms. If they did not mail their FIT kit within 4 weeks, they received a reminder call and were called again at 8 weeks if the test still was not received.
RESULTS


A total of 620 patients were enrolled. Approximately 55% were female, 66% were African American, and 40% had limited literacy. The overall FIT completion rate was 68%: 69.2% in the automated telephone call arm and 67% in the personal call arm. Greater than one-half of the patients (range, 58%-60%) returned the FIT kit without receiving a telephone call. There was no difference noted with regard to the effectiveness of the follow-up calls; each increased the return rate by 9%.
CONCLUSIONS


Providing FIT kits and literacy-appropriate education at regularly scheduled clinic visits with a follow-up telephone call when needed was found to increase CRC screening among low-income, rural patients. The lower cost automated call was just as effective as the personal call.",2019,"There was no difference noted with regard to the effectiveness of the follow-up calls; each increased the return rate by 9%.
","['colorectal cancer (CRC) screening rates among those of low socioeconomic status, with fewer years of education, lacking health insurance, or living in rural areas', 'rural community clinics', 'Approximately 55% were female, 66% were African American, and 40% had limited literacy', 'Patients aged 50 to 75\xa0years residing in 4 rural community clinics in Louisiana were given a structured interview that assessed demographic, health literacy and CRC screening barriers, knowledge, and attitudes', '620 patients were enrolled']","['telephone call or personal call', 'health literacy intervention']","['return rate', 'overall FIT completion rate', 'colorectal cancer screening']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0024024', 'cui_str': 'Louisiana'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4708788', 'cui_str': '620'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",620.0,0.0966608,"There was no difference noted with regard to the effectiveness of the follow-up calls; each increased the return rate by 9%.
","[{'ForeName': 'Connie L', 'Initials': 'CL', 'LastName': 'Arnold', 'Affiliation': 'Department of Medicine, Louisiana State University Health Sciences Center-Shreveport, Shreveport, Louisiana.'}, {'ForeName': 'Alfred W', 'Initials': 'AW', 'LastName': 'Rademaker', 'Affiliation': 'Department of Preventive Medicine, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Morris', 'Affiliation': 'Department of Medicine, Louisiana State University Health Sciences Center-Shreveport, Shreveport, Louisiana.'}, {'ForeName': 'Laurie Anne', 'Initials': 'LA', 'LastName': 'Ferguson', 'Affiliation': 'College of Nursing and Health, Loyola University New Orleans, New Orleans, Louisiana.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Wiltz', 'Affiliation': 'Teche Action Clinic, Franklin, Louisiana.'}, {'ForeName': 'Terry C', 'Initials': 'TC', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Louisiana State University Health Sciences Center-Shreveport, Shreveport, Louisiana.'}]",Cancer,['10.1002/cncr.32398']
635,31628359,Manual versus Pump Infusion of Distending Media for Hysteroscopic Procedures: A Randomized Controlled Trial.,"Fluid overload is a potential complication of hysteroscopic procedures with the possibility of dangerous electrolyte changes. This prospective randomized controlled trial aimed to compare perioperative outcomes and changes in electrolytes after hysteroscopic procedures between the manual infusion (MI) and the pump infusion (PI) methods for distending media infusion. One hundred consecutive women who had hysteroscopic procedures between December 2013 and February 2017 were recruited and randomly allocated to either the MI or PI group. The PI group was associated with an increased volume of infused fluid and collected fluid compared with the volumes of the MI group. Almost all serum electrolyte levels differed significantly between the baseline and postoperative values in both groups; however, no significant differences were noted between the groups. The change in potassium level was positively correlated with the volume of fluid deficit (Spearman's rho = 0.24, P = 0.03), whereas the change in calcium level was negatively correlated with the volume of fluid deficit (Spearman's rho = -0.26, P = 0.046). With no between-group differences in the changes in the other perioperative parameters and electrolytes, the MI method can be a good alternative for delivering distending media for hysteroscopic procedures.",2019,"Almost all serum electrolyte levels differed significantly between the baseline and postoperative values in both groups; however, no significant differences were noted between the groups.","['Hysteroscopic Procedures', 'One hundred consecutive women who had hysteroscopic procedures between December 2013 and February 2017']","['manual infusion (MI) and the pump infusion (PI) methods', 'Manual versus Pump Infusion of Distending Media']","['serum electrolyte levels', 'change in potassium level', 'calcium level']","[{'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}]","[{'cui': 'C1287347', 'cui_str': 'Finding of serum electrolyte levels (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0428289', 'cui_str': 'Finding of potassium level (finding)'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement (procedure)'}]",100.0,0.0619477,"Almost all serum electrolyte levels differed significantly between the baseline and postoperative values in both groups; however, no significant differences were noted between the groups.","[{'ForeName': 'Wan-Hua', 'Initials': 'WH', 'LastName': 'Ting', 'Affiliation': 'Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital, New Taipei, Taiwan.'}, {'ForeName': 'Ho-Hsiung', 'Initials': 'HH', 'LastName': 'Lin', 'Affiliation': 'Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital, New Taipei, Taiwan.'}, {'ForeName': 'Sheng-Mou', 'Initials': 'SM', 'LastName': 'Hsiao', 'Affiliation': 'Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital, New Taipei, Taiwan. smhsiao2@gmail.com.'}]",Scientific reports,['10.1038/s41598-019-51252-3']
636,29288507,"Effectiveness of executive function training on mental set shifting, working memory and inhibition in healthy older adults: A double-blind randomized controlled trials.","AIMS


The aim of this study was to evaluate the effectiveness of executive function training on mental set shifting, working memory and inhibition for healthy older adults.
BACKGROUND


Executive functions control and guide individuals' behaviours through a top-down cognitive model and have been regarded as the exhibition and integration of various high-level cognitive functions. However, prior studies have rarely focused on the subcomponent indicators of executive function, such as mental set shifting, working memory and inhibition in healthy older adults.
DESIGN


Randomized controlled trial.
METHODS


A total of 62 participants were recruited between January 2015 - March 2017, with both groups attending a 30-min training session three times per week for 8 weeks. Executive function training group received the training content that focused on the mental set shifting, working memory and inhibition. Active control group engaged in passive information activities. The primary outcome was mental set shifting, measured by the Wisconsin card sort test. The secondary outcomes were working memory measured by digit span and inhibition measured by the Stroop color word test.
RESULTS


The executive function training group had statistically significant higher scores of mental set shifting and working memory at immediate follow-up and that its effect on mental set shifting could be maintained for 3-6 months. However, this training did not have any statistically significant results on inhibition.
CONCLUSION


The executive function training may be an effective preventive intervention for healthy older adults. Future studies are recommended to include a broader range of participants with different levels of cognitive function.",2018,The executive function training group had statistically significant higher scores of mental set shifting and working memory at immediate follow-up and that its effect on mental set shifting could be maintained for 3-6 months.,"['62 participants were recruited between January 2015 - March 2017', 'healthy older adults']","['Executive function training', 'executive function training']","['working memory measured by digit span and inhibition measured by the Stroop color word test', 'mental set shifting and working memory', 'mental set shifting, measured by the Wisconsin card sort test']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0589092', 'cui_str': 'Executive functions training (regime/therapy)'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0582675', 'cui_str': 'Stroop neuropsychological screening test (assessment scale)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",62.0,0.0872858,The executive function training group had statistically significant higher scores of mental set shifting and working memory at immediate follow-up and that its effect on mental set shifting could be maintained for 3-6 months.,"[{'ForeName': 'Huei-Ling', 'Initials': 'HL', 'LastName': 'Chiu', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Pi-Tuan', 'Initials': 'PT', 'LastName': 'Chan', 'Affiliation': 'Department of Nursing, En Chu Kong Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ching-Chiu', 'Initials': 'CC', 'LastName': 'Kao', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Hsin', 'Initials': 'H', 'LastName': 'Chu', 'Affiliation': 'Institute of Aerospace and Undersea Medicine, School of Medicine, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Pi-Chen', 'Initials': 'PC', 'LastName': 'Chang', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Shu-Tai Sheen', 'Initials': 'SS', 'LastName': 'Hsiao', 'Affiliation': 'Department of Nursing, Taipei Medical University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Doresses', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Institute of Aerospace and Undersea Medicine, School of Medicine, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Wen-Chi', 'Initials': 'WC', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, Taipei Veterans General Hospital Yuanshan Branches, Yilan, Taiwan.'}, {'ForeName': 'Kuei-Ru', 'Initials': 'KR', 'LastName': 'Chou', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}]",Journal of advanced nursing,['10.1111/jan.13519']
637,31621832,Chemoprophylaxis Vaccination: Phase I Study to Explore Stage-specific Immunity to Plasmodium falciparum in US Adults.,"BACKGROUND


Chemoprophylaxis vaccination with sporozoites (CVac) with chloroquine induces protection against a homologous Plasmodium falciparum sporozoite (PfSPZ) challenge, but whether blood-stage parasite exposure is required for protection remains unclear. Chloroquine suppresses and clears blood-stage parasitemia, while other antimalarial drugs, such as primaquine, act against liver-stage parasites. Here, we evaluated CVac regimens using primaquine and/or chloroquine as the partner drug to discern whether blood-stage parasite exposure impacts protection against homologous controlled human malaria infection.
METHODS


In a Phase I, randomized, partial double-blind, placebo-controlled study of 36 malaria-naive adults, all CVac subjects received chloroquine prophylaxis and bites from 12-15 P. falciparum-infected mosquitoes (CVac-chloroquine arm) at 3 monthly iterations, and some received postexposure primaquine (CVac-primaquine/chloroquine arm). Drug control subjects received primaquine, chloroquine, and uninfected mosquito bites. After a chloroquine washout, subjects, including treatment-naive infectivity controls, underwent homologous, PfSPZ controlled human malaria infection and were monitored for parasitemia for 21 days.
RESULTS


No serious adverse events occurred. During CVac, all but 1 subject in the study remained blood-smear negative, while only 1 subject (primaquine/chloroquine arm) remained polymerase chain reaction-negative. Upon challenge, compared to infectivity controls, 3/3 chloroquine arm subjects displayed delayed patent parasitemia (P = .01) but not sterile protection, while 3/11 primaquine/chloroquine subjects remained blood-smear negative.
CONCLUSIONS


CVac-primaquine/chloroquine is safe and induces sterile immunity to P. falciparum in some recipients, but a single 45 mg dose of primaquine postexposure does not completely prevent blood-stage parasitemia. Unlike previous studies, CVac-chloroquine did not produce sterile immunity.
CLINICAL TRIALS REGISTRATION


NCT01500980.",2020,No serious adverse events occurred.,"['36 malaria-naïve adults, all CVac subjects received', 'U.S. adults']","['primaquine, chloroquine, and uninfected mosquito bites', 'CVac-primaquine/chloroquine', 'Chemoprophylaxis vaccination', 'chloroquine or primaquine', 'placebo', 'primaquine/chloroquine', 'chloroquine prophylaxis and bites from 12-15 P. falciparum-infected mosquitoes (CVac-chloroquine arm) at 3 monthly iterations, and some received post-exposure primaquine (CVac-primaquine/chloroquine arm', 'primaquine', 'Chloroquine', 'CVac-chloroquine', 'chloroquine']","['blood smear-negative', 'blood-stage parasitemia', 'blood smear negative', 'delayed patent parasitemia']","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0417744', 'cui_str': 'Mosquito bite (disorder)'}, {'cui': 'C0282515', 'cui_str': 'Chemoprophylaxis'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0005658', 'cui_str': 'Bites'}, {'cui': 'C0026584', 'cui_str': 'Mosquitoes'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0005768'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0030650', 'cui_str': 'Patent'}]",,0.0560313,No serious adverse events occurred.,"[{'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Healy', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Murphy', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Jen C C', 'Initials': 'JCC', 'LastName': 'Hume', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shelton', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Kuntz', 'Affiliation': 'Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Wesley C', 'Initials': 'WC', 'LastName': 'Van Voorhis', 'Affiliation': 'Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Moodie', 'Affiliation': 'Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Metch', 'Affiliation': 'Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Ruobing', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Silver-Brace', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Fishbaugher', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kennedy', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Olivia C', 'Initials': 'OC', 'LastName': 'Finney', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Chaturvedi', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Sean R', 'Initials': 'SR', 'LastName': 'Marcsisin', 'Affiliation': 'Military Malaria Research Program, Division of Experimental Therapeutics, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Charlotte V', 'Initials': 'CV', 'LastName': 'Hobbs', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Warner-Lubin', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Angela K', 'Initials': 'AK', 'LastName': 'Talley', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Wong-Madden', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Stuart', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wald', 'Affiliation': 'Department of Laboratory Medicine and Microbiology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Kappe', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Patrick E', 'Initials': 'PE', 'LastName': 'Duffy', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1010']
638,31609433,Efficacy and Safety of Varenicline for Adolescent Smoking Cessation: A Randomized Clinical Trial.,"Importance


Cigarette smoking is the leading cause of preventable morbidity and mortality in the United States and worldwide, and most tobacco users begin smoking in adolescence. Although advances have yielded efficacious pharmacotherapies to complement smoking cessation counseling in adults, far less progress has been made in addressing tobacco use in adolescence.
Objective


To evaluate the efficacy and safety of varenicline tartrate for smoking cessation in adolescents and young adults.
Design, Setting, and Participants


This 2-group randomized, placebo-controlled, double-blind intention-to-treat clinical trial enrolled a volunteer sample of treatment-seeking adolescent and young adult cigarette smokers (n = 157) aged 14 to 21 years at an outpatient clinical site in Charleston, South Carolina, from August 15, 2012, to October 20, 2017. Follow-up was completed on January 25, 2018. Data were analyzed from March 19, 2018, to August 11, 2018, with further revisions completed April 10, 2019.
Interventions


Participants were randomized in a 1:1 ratio to a 12-week course of varenicline (n = 77) or placebo (n = 80). All participants received weekly smoking cessation counseling.
Main Outcomes and Measures


The preselected primary efficacy outcome was urine cotinine level-confirmed 7-day abstinence at the end of treatment. Secondary efficacy outcomes included weekly abstinence throughout active treatment, abstinence at posttreatment follow-up visits, and time to first 7-day abstinence. The primary safety outcome was the frequency of treatment-emergent adverse events.
Results


A total of 157 participants were enrolled (94 male [59.9%]; mean [SD] age, 19.1 [1.5] years). The varenicline and placebo groups did not differ in the primary outcome of cotinine-confirmed self-reported 7-day abstinence at the end of treatment (varenicline group, 4 of 45 [8.9%]; placebo group, 4 of 45 [8.9%]; risk ratio [RR], 0.97; 95% CI, 0.29-2.99; P = .96). However, among secondary outcomes, the varenicline group achieved self-reported earlier abstinence of at least 7 days (hazard ratio, 1.91; 95% CI, 1.12-3.27) and demonstrated higher rates of self-reported weekly abstinence during the full course of treatment (RR, 1.81; 95% CI, 1.09-2.99; P = .02) and at posttreatment follow-up (RR, 1.82; 95% CI, 1.01-3.28; P = .02). Study medication was generally well tolerated, and treatment-emergent adverse events did not differ between groups (any adverse events, 55 [71.4%] in the varenicline group vs 60 [75.0%] in the placebo group; RR, 0.95; 95% CI, 0.79-1.15; P = .61).
Conclusions and Relevance


When added to weekly cessation counseling for adolescent cigarette smokers, varenicline, compared with placebo, was well tolerated but did not improve end-of-treatment abstinence. However, varenicline may hasten abstinence and yield improvements in posttreatment abstinence outcomes.
Trial Registration


ClinicalTrials.gov identifier: NCT01509547.",2019,"The varenicline and placebo groups did not differ in the primary outcome of cotinine-confirmed self-reported 7-day abstinence at the end of treatment (varenicline group, 4 of 45 [8.9%]; placebo group, 4 of 45 [8.9%]; risk ratio [RR], 0.97; 95% CI, 0.29-2.99; P = .96).","['A total of 157 participants were enrolled (94 male [59.9', 'volunteer sample of treatment-seeking adolescent and young adult cigarette smokers (n\u2009=\u2009157) aged 14 to 21 years at an outpatient clinical site in Charleston, South Carolina, from August 15, 2012, to October 20, 2017', 'Adolescent Smoking Cessation', 'adolescent cigarette smokers', 'adolescents and young adults', 'Data were analyzed from March 19, 2018, to August 11, 2018, with further revisions completed April 10, 2019']","['weekly smoking cessation counseling', 'varenicline', 'varenicline tartrate', 'Varenicline', 'placebo', 'varenicline and placebo']","['rates of self-reported weekly abstinence', 'cotinine-confirmed self-reported 7-day abstinence', 'urine cotinine level-confirmed 7-day abstinence', 'tolerated, and treatment-emergent adverse events', 'frequency of treatment-emergent adverse events', 'weekly abstinence throughout active treatment, abstinence at posttreatment follow-up visits, and time to first 7-day abstinence', 'self-reported earlier abstinence', 'efficacy and safety', 'Efficacy and Safety']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0037716', 'cui_str': 'South Carolina'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C1711887', 'cui_str': 'varenicline tartrate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1278256', 'cui_str': 'Urine cotinine measurement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",157.0,0.469726,"The varenicline and placebo groups did not differ in the primary outcome of cotinine-confirmed self-reported 7-day abstinence at the end of treatment (varenicline group, 4 of 45 [8.9%]; placebo group, 4 of 45 [8.9%]; risk ratio [RR], 0.97; 95% CI, 0.29-2.99; P = .96).","[{'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Tomko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Squeglia', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Saladin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.3553']
639,31628482,"A double-blind, placebo-controlled, phase II, randomized study of lovastatin therapy in the treatment of mildly active rheumatoid arthritis.","OBJECTIVES


3-hydroxy-3-methylglutaryl coenzyme-A (HMG Co-A) reductase inhibitors (statins) are standard treatment for hyperlipidaemia. In addition to lipid-lowering abilities, statins exhibit multiple anti-inflammatory effects. The objectives of this study were to determine whether treatment of patients with RA with lovastatin decreased CRP or reduced disease activity.
METHODS


We conducted a randomized double-blind placebo-controlled 12 week trial of lovastatin vs placebo in 64 RA patients with mild clinical disease activity but an elevated CRP. The primary efficacy end point was the reduction in mean log CRP. Secondary end points included disease activity, RF and anti-CCP antibody titres. Mechanistic end points included levels of serum cytokines. Safety was assessed; hepatic and muscle toxicities were of particular interest.
RESULTS


Baseline features were similar between groups. No significant difference in mean log CRP reduction between the two groups was observed, and disease activity did not change from baseline in either treatment group. Mechanistic analyses did not reveal significant changes in any biomarkers. A post hoc analysis of subjects not using biologic therapy demonstrated a significantly greater proportion achieving ⩾20% reduction in CRP from baseline in the lovastatin group compared with placebo (P-value = 0.007). No difference was observed in subjects receiving biologics. Lovastatin was well tolerated with no serious safety concerns.
CONCLUSION


This study showed no anti-inflammatory or clinical effects on RA disease activity after 12 weeks of treatment with lovastatin. Lovastatin had a modest effect on CRP in subjects not using biologics, suggesting statins may be anti-inflammatory in selected patients.
TRIAL REGISTRATION


ClinicalTrials.gov, http://clinicaltrials.gov, NCT00302952.",2020,"No significant difference in mean log CRP reduction between the two groups was observed, and disease activity did not change from baseline in either treatment group.","['mildly active rheumatoid arthritis', 'hyperlipidaemia', 'patients with RA with', '64 RA patients with mild clinical disease activity but an elevated CRP']","['lovastatin', '3-hydroxy-3-methylglutaryl coenzyme-A (HMG Co-A) reductase inhibitors (statins', 'lovastatin therapy', 'placebo', 'lovastatin vs placebo', 'Lovastatin']","['mean log CRP', 'CRP', 'hepatic and muscle toxicities', 'mean log CRP reduction', 'disease activity, RF and anti-CCP antibody titres', 'RA disease activity', 'disease activity', 'levels of serum cytokines']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0024027', 'cui_str': 'Lovastatin'}, {'cui': 'C0047420', 'cui_str': 'S-(hydrogen 3-hydroxy-3-methylpentanedioate) coenzyme A'}, {'cui': 'C0025326', 'cui_str': 'Gonadotropins, Human Menopausal'}, {'cui': 'C0030016', 'cui_str': 'Reductases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4318437', 'cui_str': 'Anti-CCP'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}]",,0.344131,"No significant difference in mean log CRP reduction between the two groups was observed, and disease activity did not change from baseline in either treatment group.","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Aranow', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cush', 'Affiliation': 'Division of Rheumatology, Baylor University Medical Center, Dallas, USA.'}, {'ForeName': 'Marcy B', 'Initials': 'MB', 'LastName': 'Bolster', 'Affiliation': 'Division of Rheumatology, Massachusetts General Hospital, Boston, USA.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Striebich', 'Affiliation': 'Division of Rheumatology, University of Colorado, Denver, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""Dall'era"", 'Affiliation': 'Division of Rheumatology, University of California, San Francisco, USA.'}, {'ForeName': 'Meggan', 'Initials': 'M', 'LastName': 'Mackay', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Olech', 'Affiliation': 'Department of Internal Medicine, University of Nevada School of Medicine, Las Vegas, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Frech', 'Affiliation': 'Department of Internal Medicine, University of Utah, Internal Medicine, Salt Lake City, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Box', 'Affiliation': 'Box Arthritis & Rheumatology of the Carolinas, Charlotte, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Keating', 'Affiliation': 'Division of Rheumatology, Scripps Green Hospital, La Jolla, USA.'}, {'ForeName': 'Mary Chester', 'Initials': 'MC', 'LastName': 'Wasko', 'Affiliation': 'Division of Rheumatology, Western Pennsylvania Hospital, Pittsburgh, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'St Clair', 'Affiliation': 'Division of Rheumatology and Immunology, Duke University School of Medicine, Durham, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, USA.'}, {'ForeName': 'Weiquang', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'PetaGay', 'Initials': 'P', 'LastName': 'Ricketts', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Welch', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA.'}, {'ForeName': 'Sherrie', 'Initials': 'S', 'LastName': 'Callahan', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Spychala', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Boyle', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'York', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Keyes-Elstein', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Goldmuntz', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Diamond', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Davidson', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez471']
640,31862174,Effect of Intensive vs Standard Blood Pressure Treatment Upon Erectile Function in Hypertensive Men: Findings From the Systolic Blood Pressure Intervention Trial.,"INTRODUCTION


The effect of intensive blood pressure control upon erectile function in men with hypertension, but without diabetes, is largely unknown.
AIM


To examine the effects of intensive systolic blood pressure (SBP) lowering on erectile function in a multiethnic clinical trial of men with hypertension.
METHODS


We performed subgroup analyses from the Systolic Blood Pressure Intervention Trial ([SPRINT]; ClinicalTrials.gov: NCT120602, in a sample of 1255 men aged 50 years or older with hypertension and increased cardiovascular disease risk. Participants were randomly assigned to an intensive treatment group (SBP goal of <120 mmHg) or a standard treatment group (SBP goal of <140 mmHg).
MAIN OUTCOME MEASURE


The main outcome measure was change in erectile function from baseline, using the 5-item International Index of Erectile Function (IIEF-5) total score, and erectile dysfunction ([ED]; defined as IIEF-5 score ≤21) after a median follow-up of 3 years.
RESULTS


At baseline, roughly two-thirds (66.1%) of the sample had self-reported ED. At 48 months after randomization, we determined that the effects of more intensive blood pressure lowering were significantly moderated by race-ethnicity (p for interaction = 0.0016), prompting separate analyses stratified by race-ethnicity. In non-Hispanic whites, participants in the intensive treatment group reported slightly, but significantly better change in the IIEF-5 score than those in the standard treatment group (mean difference = 0.67; 95% CI = 0.03, 1.32; P = 0.041). In non-Hispanic blacks, participants in the intensive group reported slightly worse change in the IIEF-5 score than those in the standard group (mean difference = -1.17; 95% CI = -1.92, -0.41; P = 0.0025). However, in non-Hispanic whites and non-Hispanic blacks, further adjustment for the baseline IIEF-5 score resulted in nonsignificant differences (P > 0.05) according to the treatment group. In Hispanic/other participants, there were no significant differences in change in the IIEF-5 score between the two treatment groups (P = 0.40). In a subgroup of 280 participants who did not report ED at baseline, the incidence of ED did not differ in the two treatment groups (P = 0.53) and was without interaction by race-ethnicity.
CLINICAL IMPLICATIONS


The effect of intensive treatment of blood pressure on erectile function was very small overall and likely not of great clinical magnitude.
STRENGTH & LIMITATIONS


Although this study included a validated measure of erectile function, testosterone, other androgen, and estrogen levels were not assessed.
CONCLUSION


In a sample of male patients at high risk for cardiovascular events but without diabetes, targeting a SBP of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in statistically significant effects on erectile function that differed in accordance with race-ethnicity, although the clinical importance of the differences may be of small magnitude. Foy CG, Newman JC, Russell GB, et al. Effect of Intensive vs Standard Blood Pressure Treatment Upon Erectile Function in Hypertensive Men: Findings From the Systolic Blood Pressure Intervention Trial. J Sex Med 2020;17:238-248.",2020,"In non-Hispanic whites, participants in the intensive treatment group reported slightly, but significantly better change in the IIEF-5 score than those in the standard treatment group (mean difference = 0.67; 95% CI = 0.03, 1.32; P = 0.041).","['men with hypertension, but without diabetes', 'men with hypertension', '1255 men aged 50 years or older with hypertension and increased cardiovascular disease risk', 'Hypertensive Men']","['Intensive vs Standard Blood Pressure Treatment', 'intensive blood pressure control', 'intensive systolic blood pressure (SBP) lowering', 'intensive treatment group (SBP goal of <120 mmHg) or a standard treatment group (SBP goal of <140 mmHg']","['erectile function', 'erectile function, testosterone, other androgen, and estrogen levels', '5-item International Index of Erectile Function (IIEF-5) total score, and erectile dysfunction ([ED]; defined as IIEF-5 score ≤21', 'change in erectile function', 'incidence of ED', 'intensive blood pressure lowering', 'IIEF-5 score', 'cardiovascular events']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",1255.0,0.183276,"In non-Hispanic whites, participants in the intensive treatment group reported slightly, but significantly better change in the IIEF-5 score than those in the standard treatment group (mean difference = 0.67; 95% CI = 0.03, 1.32; P = 0.041).","[{'ForeName': 'Capri G', 'Initials': 'CG', 'LastName': 'Foy', 'Affiliation': 'Division of Public Health Sciences, Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: cfoy@wakehealth.edu.'}, {'ForeName': 'Jill C', 'Initials': 'JC', 'LastName': 'Newman', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistic and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Greg B', 'Initials': 'GB', 'LastName': 'Russell', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistic and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Dan R', 'Initials': 'DR', 'LastName': 'Berlowitz', 'Affiliation': 'Bedford VA Hospital, Bedford, MA, and Boston University School of Medicine and Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Bates', 'Affiliation': ""Michael E. DeBakey Veterans' Administration Medical Center, Houston, TX, USA.""}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Burgner', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Thaddeus Y', 'Initials': 'TY', 'LastName': 'Carson', 'Affiliation': 'Division of Internal Medicine, Department of Medicine, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Division of Nephrology, Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Doumas', 'Affiliation': 'Second Propedeutic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Robin Y', 'Initials': 'RY', 'LastName': 'Hughes', 'Affiliation': 'University Hospitals Case Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Kostis', 'Affiliation': 'Robert Wood Johnson Medical School, Rutgers University, University of Medicine and Dentistry of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Peter van', 'Initials': 'PV', 'LastName': 'Buren', 'Affiliation': ""Department of Internal Medicine, Dallas Veterans' Administration Medical Center and University of Texas Southwestern Medical Center, Dallas, TX, USA.""}, {'ForeName': 'Virginia G', 'Initials': 'VG', 'LastName': 'Wadley', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, Department of Medicine, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.11.256']
641,28393317,Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial.,"PURPOSE


To report the results of a randomized controlled trial using an electronic monitoring device (EM) plus a motivational interviewing (MI) intervention to enhance adherence to disease-modifying therapies (DMT) in pediatric MS.
METHODS


Fifty-two youth with MS (16.03 ± 2.2 years) were randomized to receive either MI (n = 25) (target intervention) or a MS medication video (n = 27) (attention control). Primary endpoint was change in adherence. Secondary outcomes included changes in quality of life, well-being and self-efficacy. Random effects modeling and Cohen's effect size computation evaluated intervention impact.
RESULTS


Longitudinal random effect models revealed that the MI group decreased their EM adherence (GroupxTime interaction = -0.19), while increasing frequency of parental DMT reminder (26.01)/administration (11.69). We found decreased EM use in the MI group at 6 months (Cohen's d = -0.61), but increased pharmacy refill adherence (d = 0.23). Parental reminders about medication increased in MI subjects vs controls (d = 0.59 at 3 months; d = 0.70 at 6 months). We found increases in self-reported adherence (d = 0.21) at 3 but not 6 months, fewer barriers to adherence at three (d = -0.58) and six months (d = -0.31), better physical (d = 0.23 at 3 months; d = 0.45 at 6 months), emotional (d = 0.25 at 3 months) and self-efficacy function (d = 0.55 at 3 months; 0.48 at 6 months), but worse well-being, including self-acceptance (d = -0.53 at 6 months) and environmental mastery (d = -0.42 at 3 and 6 months) in intervention as compared to control patients.
CONCLUSIONS


Participants receiving MI + EM experienced worsening on objective measures of adherence and increased parental involvement, but improved on some self- and parent-reported measures. MI participants reported improvements in quality of life and self-efficacy, but worsened well-being.",2017,"We found decreased EM use in the MI group at 6 months (Cohen's d = -0.61), but increased pharmacy refill adherence (d = 0.23).","['youth', 'youth with MS (16.03\xa0±\xa02.2\xa0years', 'Fifty-two']","['electronic monitoring device (EM) plus a motivational interviewing (MI) intervention', 'MI (n\xa0=\xa025) (target intervention) or a MS medication video (n\xa0=\xa027) (attention control', 'electronic monitoring device and behavioral feedback']","['self-reported adherence', 'quality of life and self-efficacy', 'pharmacy refill adherence', 'change in adherence', 'environmental mastery', 'frequency of parental DMT reminder', 'EM adherence', 'self-efficacy function', 'changes in quality of life, well-being and self-efficacy']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0027183', 'cui_str': 'Dimethyltryptamine'}, {'cui': 'C0031843', 'cui_str': 'function'}]",52.0,0.0664187,"We found decreased EM use in the MI group at 6 months (Cohen's d = -0.61), but increased pharmacy refill adherence (d = 0.23).","[{'ForeName': 'E Ann', 'Initials': 'EA', 'LastName': 'Yeh', 'Affiliation': 'Pediatric MS and Neuroinflammatory Disorders Program, Division of Neurology, Department of Pediatrics, Neuroscience and Mental Health, Hospital for Sick Children Research Institute, Hospital for Sick Children, 555 University Avenue, Rm 6D33, Toronto, ON, M5G1X8, Canada. ann.yeh@sickkids.ca.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Grover', 'Affiliation': 'Pediatric MS and Neuroinflammatory Disorders Program, Division of Neurology, Department of Pediatrics, Neuroscience and Mental Health, Hospital for Sick Children Research Institute, Hospital for Sick Children, 555 University Avenue, Rm 6D33, Toronto, ON, M5G1X8, Canada.'}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Powell', 'Affiliation': 'DeltaQuest Foundation Inc., 31 Mitchell Road, Concord, MA, 01742, USA.'}, {'ForeName': 'Gulay', 'Initials': 'G', 'LastName': 'Alper', 'Affiliation': ""Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, 4401 Penn Avenue, Pittsburgh, PA, 15224, USA.""}, {'ForeName': 'Brenda L', 'Initials': 'BL', 'LastName': 'Banwell', 'Affiliation': ""Division of Neurology, Children's Hospital of Philadelphia, 3401 Civic Center Blvd., Philadelphia, PA, 19104, USA.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Edwards', 'Affiliation': 'Department of Psychiatry, The Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G1X8, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gorman', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, 300 Longwood Avenue, Boston, MA, 02115, USA.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Graves', 'Affiliation': 'University of California San Francisco, 505 Parnassus Avenue, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Lotze', 'Affiliation': ""Texas Children's Hospital, Baylor College of Medicine, 6621 Fannin Street, Houston, TX, 77030, USA.""}, {'ForeName': 'Jean K', 'Initials': 'JK', 'LastName': 'Mah', 'Affiliation': ""Alberta Children's Hospital, 2888 Shanganappi Trail NW, Calgary, AB, T3B 6A8, Canada.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Mednick', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, 300 Longwood Avenue, Boston, MA, 02115, USA.""}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Ness', 'Affiliation': 'University of Alabama at Birmingham, 1720 2nd Avenue, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Obadia', 'Affiliation': 'ELLICSR: Health, Wellness, and Cancer Survivorship Centre, University Health Network, 585 University Avenue, Toronto, ON, M5G 2C4, Canada.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Slater', 'Affiliation': 'Department of Psychiatry, The Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G1X8, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Waldman', 'Affiliation': ""Division of Neurology, Children's Hospital of Philadelphia, 3401 Civic Center Blvd., Philadelphia, PA, 19104, USA.""}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Waubant', 'Affiliation': 'University of California San Francisco, 505 Parnassus Avenue, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Carolyn E', 'Initials': 'CE', 'LastName': 'Schwartz', 'Affiliation': 'DeltaQuest Foundation Inc., 31 Mitchell Road, Concord, MA, 01742, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-017-1571-z']
642,31487406,"Efficacy and safety of tildrakizumab for plaque psoriasis with continuous dosing, treatment interruption, dose adjustments and switching from etanercept: results from phase III studies.","BACKGROUND


Chronic psoriasis may require medication adjustments over time.
OBJECTIVES


To evaluate the efficacy/safety of tildrakizumab in subgroups from the reSURFACE studies (N = 1862) that received continuous dosing, higher/lower dosing, treatment interruption/reinitiation and initiation.
METHODS


Responders [Psoriasis Area and Severity Index (PASI) ≥ 75%] and partial responders (PASI ≥ 50% to < 75%) in Part 3 of the reSURFACE studies (weeks 28-52 or week 64) who received tildrakizumab 200 mg or 100 mg were rerandomized to the same dosage (T100/T100 or T200/T200), a higher/lower dosage (T100/T200 or T200/T100) or placebo (PBO) (T100/PBO or T200/PBO). Patients receiving PBO who relapsed were reinitiated to tildrakizumab. Etanercept (ETN) week-28 partial responders and nonresponders (PASI < 50%) received tildrakizumab 200 mg (ETN/T200).
RESULTS


Among T100/T100 and T200/T200 week-28 partial responders, the proportion of patients who achieved as-observed PASI 75 responses increased over time. Among T100/T200 week-28 partial responders, PASI 75 responses increased from week 32 (38·5%) to week 52 (63·2%) and remained consistent in T200/T100 week-28 responders. Among patients who relapsed in the T100/PBO and T200/PBO groups, 86% and 83% of those who reinitiated tildrakizumab achieved PASI 75 by week 64, respectively. Among ETN/T200 week-28 partial responders, PASI 75 responses (nonresponder imputation) increased from week 32 (24·1%) to week 52 (74·7%). PASI 90, PASI 100 and Physician's Global Assessment responses were consistent with PASI 75 results. Treatment was well tolerated.
CONCLUSIONS


Patients generally fared well with tildrakizumab maintenance, reinitiation, dose adjustment or initiation. What's already known about this topic? Tildrakizumab demonstrated significant efficacy vs. placebo with a positive safety profile during the first 28 weeks of treatment in two randomized double-blind trials. What does this study add? Treatment scenarios with tildrakizumab, such as long-term continuous dosing (up to 64 weeks), treatment interruption/reinitiation and switching from another biologic, can be part of the management of plaque psoriasis with a reasonable expectation of efficacy and tolerability.",2020,"Among ETN/T200 Week 28 partial-responders, PASI 75 responses (non-responder imputation) increased from Weeks 32 (24.1%) to 52 (74.7%).",['Responders (PASI ≥75%) and partial-responders (PASI ≥50%-<75%) in Part 3 (Weeks 28-52 or 64) receiving'],"['tildrakizumab 200 or 100 mg were re-randomised to the same dose (T100/T100 or T200/T200), higher/lower dose (T100/T200 or T200/T100), or placebo (T100/PBO or T200/PBO', 'Etanercept', 'tildrakizumab']","['PASI 90, PASI 100, and PGA responses', 'PASI 75 responses', 'Efficacy and safety', 'tolerated']","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C4043954', 'cui_str': 'tildrakizumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0289187,"Among ETN/T200 Week 28 partial-responders, PASI 75 responses (non-responder imputation) increased from Weeks 32 (24.1%) to 52 (74.7%).","[{'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Kimball', 'Affiliation': 'Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, U.S.A.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'K. Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': 'Skin Centre for Dermatology and Probity Medical Research, Peterborough, ON, Canada.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, U.S.A.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Cichanowitz', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, U.S.A.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'La Rosa', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.18484']
643,32412097,Comparison of the efficacy of electroconvulsive therapy (ECT) plus agomelatine to ECT plus placebo in treatment-resistant depression.,"OBJECTIVE


Electroconvulsive therapy (ECT) is commonly used to treat patients with treatment-resistant depression. We aimed to investigate whether combining an antidepressant agent with ECT might enhance therapeutic efficacy and prevent early relapse.
METHOD


During the acute ECT phase, patients (N = 97) with treatment-resistant depression were randomized to receive ECT plus agomelatine 50 mg/day (n = 48) or ECT plus placebo (n = 49). Symptom severity measures, including the 17-item Hamilton Depression Rating Scale (HAMD-17) and other scales, functional impairment, quality of life, neuropsychological tests, adverse events and attitudes toward ECT, were assessed regularly. Remission was defined as a HAMD-17 score ≤7. If patients achieved post-ECT remission, they were prescribed agomelatine 50 mg/day and participated in a 12-week follow-up trial. HAMD-17 was rated at 4-week intervals. Relapse was defined as a HAMD-17 score ≥14, or rehospitalization for a psychiatric reason.
RESULTS


The two treatment groups were comparable at (i) baseline variables; (ii) score changes in all symptom measures, functional impairment, quality of life, and neuropsychological tests; (iii) frequency of adverse events and attitudes toward ECT; and (iv) post-ECT response/remission rates. There were no statistically significant differences following ECT in relapse rates and time to relapse between these two groups.
CONCLUSION


Adding agomelatine to ECT yielded comparable response/remission rates to ECT without agomelatine in the acute ECT phase. Starting agomelatine in combination with ECT did not seem to be more efficacious in preventing relapse than starting agomelatine after the acute ECT course. More research is needed to guide clinical recommendations.",2020,Starting agomelatine in combination with ECT did not seem to be more efficacious in preventing relapse than starting agomelatine after the acute ECT course.,"['patients with treatment-resistant depression', 'patients (N = 97) with treatment-resistant depression']","['ECT', 'ECT plus agomelatine to ECT plus placebo', 'ECT plus agomelatine', 'Electroconvulsive therapy (ECT', 'ECT plus placebo']","['17-item Hamilton Depression Rating Scale (HAMD-17) and other scales, functional impairment, quality of life, neuropsychological tests, adverse events and attitudes toward ECT', 'response/remission rates', 'Remission', 'Relapse', 'symptom measures, functional impairment, quality of life, and neuropsychological tests, 3) frequency of adverse events and attitudes toward ECT, and 4) post-ECT response/remission rates', 'relapse rates and time to relapse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0971637', 'cui_str': 'agomelatine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",97.0,0.124056,Starting agomelatine in combination with ECT did not seem to be more efficacious in preventing relapse than starting agomelatine after the acute ECT course.,"[{'ForeName': 'C-H', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'W-C', 'Initials': 'WC', 'LastName': 'Yang', 'Affiliation': 'Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'C-C', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'W-R', 'Initials': 'WR', 'LastName': 'Cai', 'Affiliation': 'Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13183']
644,32412181,Live lectures and videos do not differ in relation to learning outcomes of dental ergonomics.,"OBJECTIVES


This study aimed to compare the knowledge attained by third-year dental students in physical ergonomics altering live lectures and videos in teaching. The second aim was to investigate implementation of the theoretical knowledge on ergonomics into practice.
MATERIAL AND METHODS


Forty-five students divided into two groups attended a live lecture (45 min) or viewed videos (45 min). After the first teaching session, the groups changed parts. All students answered a questionnaire with 13 true or false-questions on ergonomics at baseline and immediately after both teaching sessions. Friedman's test and Wilcoxon signed rank test were used to compare questionnaire scores of the student groups. Additionally, we photographed 17 randomly selected students 3 months after baseline during a simulation workshop on endodontics. We analyzed the photographs for ergonomic postures using a specific 12-point checklist.
RESULTS


At baseline, no difference in the knowledge between the two groups was discovered, when both scored 72%. After the first teaching session, significant improvement in both groups (p < .05) was found; and there was no statistically significant difference in the scores between the groups (88% in the lecture-first and 82% in the video-first group). After the second teaching session, the scores were similar in both groups. Overall all improvement in both groups was significant (p < .001). The photograph analysis showed half of the postures being in accord with the ergonomic guidelines.
CONCLUSIONS


Both live lectures and videos showed similar outcomes in teaching ergonomics. Implementation of the knowledge on ergonomics is insufficient. Videos provide an easy-to-organize alternative to live lectures in teaching dental ergonomics. New means are needed to have dental students implement their knowledge on ergonomics into practice.",2020,"After the first teaching session, significant improvement in both groups (p < .05) was found; and there was no statistically significant difference in the scores between the groups (88% in the lecture-first and 82% in the video-first group).","['Forty-five students divided into two groups attended a', 'third-year dental students in physical ergonomics altering live lectures and videos in teaching']",['live lecture (45\u2009min) or viewed videos'],['questionnaire scores'],"[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C4505395', 'cui_str': 'Physical Ergonomics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",17.0,0.0185547,"After the first teaching session, significant improvement in both groups (p < .05) was found; and there was no statistically significant difference in the scores between the groups (88% in the lecture-first and 82% in the video-first group).","[{'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Leinonen', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Marja-Liisa', 'Initials': 'ML', 'LastName': 'Laitala', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Pirttilahti', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Niskanen', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Pesonen', 'Affiliation': 'Infrastructure for Population Studies, Faculty of Medicine, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Vuokko', 'Initials': 'V', 'LastName': 'Anttonen', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}]",Clinical and experimental dental research,['10.1002/cre2.300']
645,28608744,Methylphenidate-Related Improvements in Math Performance Cannot Be Explained by Better Cognitive Functioning or Higher Academic Motivation: Evidence From a Randomized Controlled Trial.,"Objective:  This study investigated whether improvements in working memory, reaction time, lapses of attention, interference control, academic motivation, and perceived competence mediated effects of methylphenidate on math performance.  Method:  Sixty-three children (ADHD diagnosis; methylphenidate treatment; age 8-13; IQ > 70) were randomly allocated to a 7-day methylphenidate or placebo treatment in this double-blind placebo-controlled crossover study and compared with 67 controls. Data were collected at schools and analyzed using mixed-model analysis. Methylphenidate was hypothesized to improve all measures; all measures were evaluated as potential mediators of methylphenidate-related math improvements.  Results:  Controls mostly outperformed the ADHD group. Methylphenidate did not affect measures of cognitive functioning ( p  = .082-.641) or academic motivation ( p  = .199-.865). Methylphenidate improved parent ratings of their child's self-perceived competence ( p  < .01), which mediated methylphenidate efficacy on math productivity.  Conclusion:  These results question the necessity of improvements in specific cognitive and motivational deficits associated with ADHD for medication-related academic improvement. They also stimulate further study of perceived competence as a mediator.",2020,Methylphenidate did not affect measures of cognitive functioning ( p = .082-.641) or academic motivation ( p = .199-.865).,['Sixty-three children (ADHD diagnosis; methylphenidate treatment; age 8-13; IQ > 70'],"['methylphenidate', 'Methylphenidate', 'placebo', 'methylphenidate or placebo']","['specific cognitive and motivational deficits', 'methylphenidate efficacy on math productivity', 'academic motivation', 'potential mediators of methylphenidate-related math improvements', ""parent ratings of their child's self-perceived competence"", 'working memory, reaction time, lapses of attention, interference control, academic motivation', 'Math Performance', 'cognitive functioning']","[{'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0558078', 'cui_str': 'Low motivation (finding)'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",63.0,0.346772,Methylphenidate did not affect measures of cognitive functioning ( p = .082-.641) or academic motivation ( p = .199-.865).,"[{'ForeName': 'Anne Fleur', 'Initials': 'AF', 'LastName': 'Kortekaas-Rijlaarsdam', 'Affiliation': 'Vrije Universiteit Amsterdam, The Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Luman', 'Affiliation': 'Vrije Universiteit Amsterdam, The Netherlands.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Sonuga-Barke', 'Affiliation': ""King's College London, UK.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bet', 'Affiliation': 'VU University Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Oosterlaan', 'Affiliation': 'Vrije Universiteit Amsterdam, The Netherlands.'}]",Journal of attention disorders,['10.1177/1087054717713640']
646,28484915,Impact of marital status and comorbid disorders on health-related quality of life after cardiac surgery.,"PURPOSE


To explore associations between HRQL, marital status, and comorbid disorders in men and women following cardiac surgery.
METHOD


A secondary analysis was completed using data from a randomized controlled trial in which 416 individuals (23% women) scheduled for elective coronary artery bypass graft and/or valve surgery were recruited between March 2012 and September 2013. HRQL was assessed using the Health State Descriptive System (15D) preoperatively, then at 2 weeks, and at 3, 6, and 12 months following cardiac surgery. Linear mixed model analyses were performed to explore associations between HRQL, social support, and comorbid disorders.
RESULTS


The overall 15D scores for the total sample improved significantly from 2 weeks to 3 months post surgery, with only a gradual change observed from 3 to 12 months. Thirty percent (n = 92) of the total sample reported a lower 15D total score at 12 months compared to preoperative status, of whom 78% (n = 71) had a negative minimum important differences (MID), indicating a worse HRQL status. When adjusted for age and marital status, women had statistically significant lower 15D total scores compared to men at 3, 6, and 12 months post surgery. Compared to pre-surgery, improvement was demonstrated in 4 out of 15 dimensions of HRQL for women, and in 6 out of 15 dimensions for men at 12 months post surgery. Both men and women associated back/neck problems, depression, and persistent pain intensity with lower HRQL; for women, not living with a partner/spouse was associated with lower HRQL up to 12 months.
CONCLUSION


Women experienced decreased HRQL and a slower first-year recovery following cardiac surgery compared to men. This study demonstrates a need for follow-up and support to help women manage their symptoms and improve their function within the first year after cardiac surgery. This was particularly pronounced for those women living alone.",2017,"Compared to pre-surgery, improvement was demonstrated in 4 out of 15 dimensions of HRQL for women, and in 6 out of 15 dimensions for men at 12 months post surgery.","['416 individuals (23% women) scheduled for elective coronary artery bypass graft and/or valve surgery were recruited between March 2012 and September 2013', 'men and women following cardiac surgery']",[],"['overall 15D scores', '15D total scores', 'lower 15D total score', 'HRQL', 'back/neck problems, depression, and persistent pain intensity with lower HRQL']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.0601303,"Compared to pre-surgery, improvement was demonstrated in 4 out of 15 dimensions of HRQL for women, and in 6 out of 15 dimensions for men at 12 months post surgery.","[{'ForeName': 'Ann Kristin', 'Initials': 'AK', 'LastName': 'Bjørnnes', 'Affiliation': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Suite 130, Toronto, ON, M5T 1P8, Canada. ann-kristin.bjornnes@hioa.no.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Parry', 'Affiliation': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Suite 130, Toronto, ON, M5T 1P8, Canada.'}, {'ForeName': 'Ragnhild', 'Initials': 'R', 'LastName': 'Falk', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Watt-Watson', 'Affiliation': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Suite 130, Toronto, ON, M5T 1P8, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Lie', 'Affiliation': 'Division of Cardiovascular and Pulmonary Diseases, Department of Cardiothoracic Surgery, Ullevål/Center for Patient Centered Heart- and Lung Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Leegaard', 'Affiliation': 'Faculty of Health Sciences, Institute of Nursing, Oslo and Akershus University College of Applied Sciences, Oslo, Norway.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-017-1589-2']
647,29016544,"Investigation of the Efficacy and Safety of Topical Vibration Anesthesia to Reduce Pain From Cosmetic Botulinum Toxin A Injections in Chinese Patients: A Multicenter, Randomized, Self-Controlled Study.","BACKGROUND


Vibration has been proved to be effective to reduce pain during facial cosmetic injections, but it has not been studied in Chinese patients.
OBJECTIVE


To investigate the efficacy and safety of vibration for pain reduction associated with cosmetic botulinum toxin A (BTX-A) injections in Chinese patients.
MATERIALS AND METHODS


In this prospective, randomized, split-face and right-left, self-controlled study, 53 patients received BTX-A injections for rhytid reduction, lower face, shoulder, and leg reshaping. Injections were given in a split-face and right-left design randomly assigned. A vibration stimulus was coadministered with BTX-A injections on one side, whereas the other side received BTX-A injections only. Patients completed a questionnaire immediately after treatment and were followed up 2 weeks later. A visual analog scale of pain sensation was statistically analyzed.
RESULTS


The patients experienced both clinically and statistically significant pain reduction when a vibration was coadministered with injections. Patients reported less pain on the treated side compared with the control side. Overall, 75% of patients preferred to receive vibration with their next treatment. No adverse events were reported.
CONCLUSION


Vibration is an effective and safe way to reduce pain during cosmetic BTX-A injections and may have applications in other cosmetic procedures.",2017,"No adverse events were reported.
","['53 patients received', 'Chinese Patients', 'Chinese patients']","['Botulinum Toxin A Injections', 'Vibration', 'cosmetic botulinum toxin A', 'BTX-A injections', 'Topical Vibration Anesthesia']","['pain reduction', 'pain', 'adverse events', 'visual analog scale of pain sensation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}]",,0.0242798,"No adverse events were reported.
","[{'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': '*Department of Dermatology and Venereology, Huaxi Hospital, Chengdu, China; †Department of Dermatology, Sichuan FreSkin Hospital, Chengdu, China; ‡Department of Dermatology, Xian FreSkin Hospital, Xian, China; §Department of Dermatology, Chongqing FreSkin Hospital, Chongqing, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': ''}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': ''}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000001349']
648,28820855,Resistance exercise order does not affect the magnitude and duration of post-exercise blood pressure in older women.,"The aim of this study was to compare the effects of two resistance exercise order on post-exercise blood pressure (BP) in trained, non-hypertensive older women. Sixteen women (68.3 ± 3.3 years, 63.5 ± 11.6 kg, 157.5 ± 5.1 cm) performed two sessions witheight exercises (3 sets of 8-12 repetitions) in distinct orders (from multi- to single-joint exercises [MS] or from single- to multi-joint exercises [SM]) and a control session, without exercise. Blood pressure and heart rate were obtained pre and post-sessions (60 min). Post-exercise hypotension was observed for systolic and mean BP in both the MS session (systolic BP: -6.9 mmHg, mean BP: -3.3 mmHg, P< 0.05) and SM session (systolic BP: -4.6 mmHg; mean BP: -1.1 mmHg). Post-exercise heart rate was higher than pre-session values until 30 min of recovery in both training sessions. Furthermore, systolic and mean blood pressure, and heart rate were lower than the values obtained in the control session (30 to 60 min and 0 min, respectively; P<0.05). There were no differences between the SM and MS sessions in any variable or at any moment. In conclusion, resistance exercise order does not interfere in the magnitude and duration of post-exercise hypotension in trained, non-hypertensive older women.",2017,There were no differences between the SM and MS sessions in any variable or at any moment.,"['Sixteen women (68.3 ± 3.3 years, 63.5 ± 11.6 kg, 157.5 ± 5.1 cm) performed two', 'trained, non-hypertensive older women', 'older women', 'hypertensive older women']","['resistance exercise order on post-exercise blood pressure (BP', 'Resistance exercise', 'sessions witheight exercises (3 sets of 8-12 repetitions) in distinct orders (from multi- to single-joint exercises [MS] or from single- to multi-joint exercises [SM]) and a control session, without exercise']","['Post-exercise heart rate', 'Furthermore, systolic and mean blood pressure, and heart rate', 'Blood pressure and heart rate', 'magnitude and duration of post-exercise blood pressure', 'systolic and mean BP']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0338416,There were no differences between the SM and MS sessions in any variable or at any moment.,"[{'ForeName': 'Crisieli M', 'Initials': 'CM', 'LastName': 'Tomeleri', 'Affiliation': 'a Metabolism, Nutrition, and Exercise Laboratory. Londrina State University. Londrina, Brazil. b Department of Physical Education, Federal University of Vale do São Francisco, Petrolina, Brazil. c Department of Physical Education, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil. d Department of Physical Education, Faculty of Physical Education and Sport, State University of Londrina, Londrina, PR, Brazil.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': ''}, {'ForeName': 'Mariana F', 'Initials': 'MF', 'LastName': 'Souza', 'Affiliation': ''}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Gerage', 'Affiliation': ''}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Marcori', 'Affiliation': ''}, {'ForeName': 'Kessi Cassiane', 'Initials': 'KC', 'LastName': 'Iarosz', 'Affiliation': ''}, {'ForeName': 'Crivaldo Gomes', 'Initials': 'CG', 'LastName': 'Cardoso-Júnior', 'Affiliation': ''}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002177']
649,28762180,Optimum support by high-flow nasal cannula in acute hypoxemic respiratory failure: effects of increasing flow rates.,"PURPOSE


Limited data exist on the correlation between higher flow rates of high-flow nasal cannula (HFNC) and its physiologic effects in patients with acute hypoxemic respiratory failure (AHRF). We assessed the effects of HFNC delivered at increasing flow rate on inspiratory effort, work of breathing, minute ventilation, lung volumes, dynamic compliance and oxygenation in AHRF patients.
METHODS


A prospective randomized cross-over study was performed in non-intubated patients with patients AHRF and a PaO 2 /FiO 2  (arterial partial pressure of oxygen/fraction of inspired oxygen) ratio of ≤300 mmHg. A standard non-occlusive facial mask and HFNC at different flow rates (30, 45 and 60 l/min) were randomly applied, while maintaining constant FiO 2  (20 min/step). At the end of each phase, we measured arterial blood gases, inspiratory effort, based on swings in esophageal pressure (ΔPes) and on the esophageal pressure-time product (PTP Pes ), and lung volume, by electrical impedance tomography.
RESULTS


Seventeen patients with AHRF were enrolled in the study. At increasing flow rate, HFNC reduced ΔPes (p < 0.001) and PTP Pes  (p < 0.001), while end-expiratory lung volume (ΔEELV), tidal volume to ΔPes ratio (V  T /ΔPes, which corresponds to dynamic lung compliance) and oxygenation improved (p < 0.01 for all factors). Higher HFNC flow rate also progressively reduced minute ventilation (p < 0.05) without any change in arterial CO 2  tension (p = 0.909). The decrease in ΔPes, PTP Pes  and minute ventilation at increasing flow rates was better described by exponential fitting, while ΔEELV, V  T /ΔPes and oxygenation improved linearly.
CONCLUSIONS


In this cohort of patients with AHRF, an increasing HFNC flow rate progressively decreased inspiratory effort and improved lung aeration, dynamic compliance and oxygenation. Most of the effect on inspiratory workload and CO 2  clearance was already obtained at the lowest flow rate.",2017,Higher HFNC flow rate also progressively reduced minute ventilation (p < 0.05) without any change in arterial CO 2  tension (p = 0.909).,"['≤300\xa0mmHg', 'Seventeen patients with AHRF were enrolled in the study', 'AHRF patients', 'non-intubated patients with patients AHRF and a PaO 2 /FiO 2  ', 'acute hypoxemic respiratory failure', 'patients with acute hypoxemic respiratory failure (AHRF']","['HFNC', 'Optimum support by high-flow nasal cannula', 'high-flow nasal cannula (HFNC']","['flow rate on inspiratory effort, work of breathing, minute ventilation, lung volumes, dynamic compliance and oxygenation', 'ΔPes, PTP Pes  and minute ventilation at increasing flow rates', 'inspiratory effort and improved lung aeration, dynamic compliance and oxygenation', 'ΔEELV, V  T /ΔPes and oxygenation improved linearly', 'PTP Pes', 'inspiratory workload and CO 2  clearance', 'expiratory lung volume (ΔEELV), tidal volume to ΔPes ratio (V  T /ΔPes, which corresponds to dynamic lung compliance) and oxygenation', 'arterial partial pressure of oxygen/fraction of inspired oxygen) ratio', 'flow rate, HFNC reduced ΔPes', 'Higher HFNC flow rate', 'arterial blood gases, inspiratory effort, based on swings in esophageal pressure (ΔPes) and on the esophageal pressure-time product (PTP Pes ), and lung volume, by electrical impedance tomography']","[{'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C4039867', 'cui_str': 'Acute type 1 respiratory failure'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0043229', 'cui_str': 'Work of Breathing'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0231953', 'cui_str': 'Lung volume, function (observable entity)'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0024112', 'cui_str': 'Lung Compliance'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0232531', 'cui_str': 'Esophageal pressure (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]",17.0,0.0356759,Higher HFNC flow rate also progressively reduced minute ventilation (p < 0.05) without any change in arterial CO 2  tension (p = 0.909).,"[{'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Mauri', 'Affiliation': 'Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Alban', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine, Section of Anesthesia and Intensive Care, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Turrini', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine, Section of Anesthesia and Intensive Care, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cambiaghi', 'Affiliation': 'Department of Medicine and Surgery, University of Milan-Bicocca, Monza, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Carlesso', 'Affiliation': 'Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Taccone', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via F. Sforza 35, 20122, Milan, Italy.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Bottino', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via F. Sforza 35, 20122, Milan, Italy.""}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Lissoni', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via F. Sforza 35, 20122, Milan, Italy.""}, {'ForeName': 'Savino', 'Initials': 'S', 'LastName': 'Spadaro', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine, Section of Anesthesia and Intensive Care, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Carlo Alberto', 'Initials': 'CA', 'LastName': 'Volta', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine, Section of Anesthesia and Intensive Care, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Gattinoni', 'Affiliation': 'Department of Anesthesiology, Emergency and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': 'Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy. antonio.pesenti@unimi.it.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Grasselli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via F. Sforza 35, 20122, Milan, Italy.""}]",Intensive care medicine,['10.1007/s00134-017-4890-1']
650,28742529,Risk factors for early mortality on antiretroviral therapy in advanced HIV-infected adults.,"BACKGROUND


Many HIV-infected individuals present with advanced HIV disease. These patients are at high risk of death after antiretroviral therapy (ART) initiation, but risk factors for death in these patients are unclear.
METHODS


We used data from a multisite randomized trial comparing empiric vs. preventive tuberculosis therapy in HIV-infected adults initiating ART with CD4 T-cell counts less than 50 cells/μl to evaluate risk factors for death within 48 weeks after ART initiation. Cox proportional hazards models were fit to evaluate characteristics present at baseline and at 4 weeks after ART initiation, including the week 4 CD4 T-cell response and new opportunistic infections.
RESULTS


Of 850 enrolled, the median pre-ART CD4 T-cell count was 18 cells/μl and 67 (7.9%) died. Baseline risk factors for death included lymphadenopathy, lower CD4 T-cell count, lower serum albumin, high white blood cell count, elevated neutrophil percentage, and lower hemoglobin. Among 746 participants with data at week 4, the median changes in CD4 T-cell count and viral load for those who died (n = 43) vs. survived were 26 vs. 56 cells/μl and -2.7 vs. -2.7 log10 copies/ml, respectively. Each 20 cell/μl lower change in week 4 CD4 T-cell count was associated with a 20% increased risk of post week-4 mortality (adjusted hazard ratio 1.20, 1.01-1.42, P = .038).
CONCLUSION


Evidence of active infection and suboptimal immunologic response during the first month of ART are associated with death in the first year after ART initiation in those with advanced HIV disease taking tuberculosis preventive therapy. Strategies to reduce early mortality in this population warrant further investigation.",2017,"Baseline risk factors for death included lymphadenopathy, lower CD4 T-cell count, lower serum albumin, high white blood cell count, elevated neutrophil percentage, and lower hemoglobin.","['Of 850', '746 participants with data at week 4', 'Many HIV-infected individuals present with advanced HIV disease', 'advanced HIV-infected adults', 'HIV-infected adults initiating ART with CD4 T-cell counts less than 50 cells/μl to evaluate risk factors for death within 48 weeks after ART initiation']",['empiric vs. preventive tuberculosis therapy'],"['risk of post week-4 mortality', 'lymphadenopathy, lower CD4 T-cell count, lower serum albumin, high white blood cell count, elevated neutrophil percentage, and lower hemoglobin', 'median changes in CD4 T-cell count and viral load', 'median pre-ART CD4 T-cell count']","[{'cui': 'C3840657', 'cui_str': '850 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]","[{'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0497156', 'cui_str': 'Adenopathy'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C1171400', 'cui_str': 'Neutrophil percentage'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]",850.0,0.462736,"Baseline risk factors for death included lymphadenopathy, lower CD4 T-cell count, lower serum albumin, high white blood cell count, elevated neutrophil percentage, and lower hemoglobin.","[{'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Bisson', 'Affiliation': 'aPerelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania bHarvard T.H. Chan School of Public Health, Boston, Massachusetts, USA cDurban International CRS, Enhancing Care Foundation, Durban, South Africa dUNC Project, Lilongwe, Malawi eUniversity of Zimbabwe, Harare, Zimbabwe fKenya Medical Research Institute (KEMRI), Kericho, Kenya gSouth African MRC-CAPRISA HIV-TB Pathogenesis and Treatment Research Unit hClinical HIV Research Unit, Department of Medicine, University of Witwatersrand, Johannesburg, South Africa iJohns Hopkins Project, Blantyre jUniversity of Malawi, College of Medicine, Blantyre, Malawi kJohns Hopkins Clinical Trials Unit, B.J. Medical College, Pune, India lGHESKIO, Port-au-Prince, Haiti mCenter for Infectious Diseases Research, Lusaka, Zambia nJohns Hopkins University School of Medicine, Baltimore oHJF-DAIDS, Division of The Henry M. Jackson Foundation, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland pUniversity of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Ritesh', 'Initials': 'R', 'LastName': 'Ramchandani', 'Affiliation': ''}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Miyahara', 'Affiliation': ''}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Mngqibisa', 'Affiliation': ''}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Matoga', 'Affiliation': ''}, {'ForeName': 'McNeil', 'Initials': 'M', 'LastName': 'Ngongondo', 'Affiliation': ''}, {'ForeName': 'Wadzanai', 'Initials': 'W', 'LastName': 'Samaneka', 'Affiliation': ''}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Koech', 'Affiliation': ''}, {'ForeName': 'Kogieleum', 'Initials': 'K', 'LastName': 'Naidoo', 'Affiliation': ''}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Rassool', 'Affiliation': ''}, {'ForeName': 'Fredrick', 'Initials': 'F', 'LastName': 'Kirui', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Banda', 'Affiliation': ''}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Mave', 'Affiliation': ''}, {'ForeName': 'Dileep', 'Initials': 'D', 'LastName': 'Kadam', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Leger', 'Affiliation': ''}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Henestroza', 'Affiliation': ''}, {'ForeName': 'Yukari C', 'Initials': 'YC', 'LastName': 'Manabe', 'Affiliation': ''}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Bao', 'Affiliation': ''}, {'ForeName': 'Johnstone', 'Initials': 'J', 'LastName': 'Kumwenda', 'Affiliation': ''}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000001606']
651,28847853,Holistic needs assessment and care plans for women with gynaecological cancer: do they improve cancer-specific health-related quality of life? A randomised controlled trial using mixed methods.,"OBJECTIVES


Holistic needs assessment (HNA) and care planning are proposed to address unmet needs of people treated for cancer. We tested whether HNA and care planning by an allied health professional improved cancer-specific quality of life for women following curative treatment for stage I-III gynaecological cancer.
METHODS


Consecutive women were invited to participate in a randomised controlled study (HNA and care planning vs usual care) at a UK cancer centre. Data were collected by questionnaire at baseline, 3 and 6 months. The outcomes were 6-month change in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (version 3), global score (primary) and, in EORTC subscales, generic quality of life and self-efficacy (secondary). The study was blinded for data management and analysis. Differences in outcomes were compared between groups. Health service utilisation and quality-adjusted life years (QALY) (from Short Form-6) were gathered for a cost-effectiveness analysis. Thematic analysis was used to interpret data from an exit interview.
RESULTS


150 women consented (75 per group); 10 undertook interviews. For 124 participants (61 intervention, 63 controls) with complete data, no statistically significant differences were seen between groups in the primary endpoint. The majority of those interviewed reported important personal gains they attributed to the intervention, which reflected trends to improvement seen in EORTC functional and symptom scales. Economic analysis suggests a 62% probability of cost-effectiveness at a £30 000/QALY threshold.
CONCLUSION


Care plan development with an allied health professional is cost-effective, acceptable and useful for some women treated for stage I-III gynaecological cancer. We recommend its introduction early in the pathway to support person-centred care.",2020,"For 124 participants (61 intervention, 63 controls) with complete data, no statistically significant differences were seen between groups in the primary endpoint.","['150 women consented (75 per group); 10 undertook interviews', 'women following curative treatment for stage I-III gynaecological cancer', 'women with gynaecological cancer', 'Consecutive women were invited to participate in a randomised controlled study (HNA and care planning vs usual care) at a UK cancer centre']","['HNA and care planning', 'Holistic needs assessment (HNA) and care planning']","['European Organisation for Research and Treatment of Cancer (EORTC', 'Health service utilisation and quality-adjusted life years (QALY', 'EORTC functional and symptom scales', 'Quality of Life Questionnaire-C30 (version 3), global score (primary) and, in EORTC subscales, generic quality of life and self-efficacy (secondary', 'cancer-specific quality of life']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0558005', 'cui_str': 'Needs Assessment'}]","[{'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0035168'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",150.0,0.178407,"For 124 participants (61 intervention, 63 controls) with complete data, no statistically significant differences were seen between groups in the primary endpoint.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sandsund', 'Affiliation': 'Therapies Department, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Towers', 'Affiliation': 'Lead Nurse Counsellor, Psychological Support Services, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Senior Statistician Research Data Management and Statistics Unit, The Royal Marsden NHS Foundation Trust, Sutton, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Tigue', 'Affiliation': 'Therapies Department, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Amyn', 'Initials': 'A', 'LastName': 'Lalji', 'Affiliation': 'Therapies Department, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Fernandes', 'Affiliation': 'Gynaeoncology Unit, Clinical Services Division, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Doyle', 'Affiliation': 'Nurse Consultant in Living With and Beyond Cancer, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': 'Surrey Health Economics Centre, School of Economics, University of Surrey, Guildford, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gage', 'Affiliation': 'Surrey Health Economics Centre, School of Economics, University of Surrey, Guildford, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Shaw', 'Affiliation': 'Therapies Department, The Royal Marsden NHS Foundation Trust, London, UK.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2016-001207']
652,31851001,Are Postoperative Intravenous Antibiotics Indicated After Laparoscopic Appendicectomy for Simple Appendicitis? A Prospective Double-blinded Randomized Controlled Trial.,"BACKGROUND


There is limited evidence for the use of postoperative antibiotics for simple appendicitis (SA) in children. Our aim was to conduct a prospective double-blinded randomized controlled trial to investigate this after a laparoscopic appendicectomy.
METHODS


Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution. Patients were randomized intraoperatively to receive either 2 postoperative intravenous doses of placebo or antibiotics (Abx). All patients received a dose of Abx at induction of anesthesia. Primary outcome was the incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation. Data are reported as number of cases (%), median (range), relative risk, and analyzed using Mann Whitney U test, Chi-square test, as appropriate, a P-value ≤0.05 was considered significant.
RESULTS


A total of 304 patients were randomized. Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis. One hundred twenty-two patients received placebo and 121 Intravenous Abx. There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7). There was also no difference in the preoperative blood results. A total of 9 WIs occurred: 8/122 (6.6%) placebo versus 1/121 (0.8%) Abx, P = 0.01 [relative risk for WI 1.83 (95% confidence interval: 1.145-2.201)]. There were no intra-abdominal abscess in either groups.
CONCLUSIONS


This prospective randomized double blinded randomized controlled trial has revealed a significant decrease in WI rates by giving 2 postoperative intravenous doses of Abx, suggesting postoperative Abx are of benefit in SA.",2019,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","['simple appendicitis (SA) in children', '304 patients were randomized', 'One hundred twenty-two patients received', 'Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis', 'Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution']","['Laparoscopic Appendicectomy', 'placebo or antibiotics (Abx', 'placebo', 'laparoscopic appendicectomy']","['intra-abdominal abscess', 'WI rates', 'postoperative length of stay in a hospital', 'incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation']","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C0243001', 'cui_str': 'Abscess, Intra-Abdominal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",243.0,0.816238,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mennie', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Gayathri', 'Initials': 'G', 'LastName': 'Panabokke', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Sharman Tan', 'Initials': 'ST', 'LastName': 'Tanny', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Pediatrics, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pacilli', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ferguson', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Ramesh M', 'Initials': 'RM', 'LastName': 'Nataraja', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}]",Annals of surgery,['10.1097/SLA.0000000000003732']
653,28981460,The Impact of a School-Based Weight Management Program Involving Parents via mHealth for Overweight and Obese Children and Adolescents with Intellectual Disability: A Randomized Controlled Trial.,"There is a scarcity of resources and studies that utilize targeted weight management interventions to engage parents via mHealth tools targeting obese children and adolescents with mild intellectual disabilities (MIDs) extended from school to a home setting. To test the feasibility and acceptability of a school-based weight program (SBWMP) involving parents via mHealth tools designed to reduce weight, enhance knowledge and adopt healthy lifestyles, and thereby achieve better psychosocial well-being among children and adolescents with MIDs. Four special schools were randomly assigned as intervention or control schools. Students from the intervention group (n = 63) were compared to those in the control group (n = 52), which comprised those with usual school planned activities and no parental involvement. Demographics were considered as covariates in a general linear model, an ordinal regression model and a binary logistic regression model analyzing the relationships between the SBWMP and the outcome variables at baseline (T0) and six months later (T1). Body weight, body mass index, and triceps and subscapular skinfold thickness were lower in the intervention group compared to the control group, although the differences were not statistically significant. There was a positive and direct impact of the SBWMP on students' health knowledge and psychological impacts in the intervention group. The SBWMP extended to the home involving parents via mHealth tools is a feasible and acceptable program for this group with MIDs and their parents.",2017,There was a positive and direct impact of the SBWMP on students' health knowledge and psychological impacts in the intervention group.,"['children and adolescents with MIDs', 'Four special schools', 'Involving Parents via mHealth for Overweight and Obese Children and Adolescents with Intellectual Disability', 'obese children and adolescents with mild intellectual disabilities (MIDs) extended from school to a home setting']","['school-based weight program (SBWMP', 'School-Based Weight Management Program', 'SBWMP']","['Body weight, body mass index, and triceps and subscapular skinfold thickness', ""students' health knowledge and psychological impacts""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}, {'cui': 'C0026106', 'cui_str': 'Mild mental handicap'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037302', 'cui_str': 'Skinfold Thickness'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",63.0,0.0282377,There was a positive and direct impact of the SBWMP on students' health knowledge and psychological impacts in the intervention group.,"[{'ForeName': 'Regina Lai-Tong', 'Initials': 'RL', 'LastName': 'Lee', 'Affiliation': 'World Health Organization Collaborating Center for Community Health Services, School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China. regina.lee@polyu.edu.hk.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Leung', 'Affiliation': 'Department of Applied & Social Sciences, The Hong Kong Polytechnic University, Hong Kong, China. leung.cynthia@polyu.edu.hk.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Infection Control Branch, Centre for Health Protection, Hong Kong, China. hong.chenhi@gmail.com.'}, {'ForeName': 'Lobo H T', 'Initials': 'LHT', 'LastName': 'Louie', 'Affiliation': 'Department of Physical Education, Hong Kong Baptist University, Hong Kong, China. s62591@hkbu.edu.hk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': ""School of Nursing and Midwifery, Queen's University, Belfast B79 7BL, Northern Ireland, UK. m.j.brown@qub.ac.uk.""}, {'ForeName': 'Jyu-Lin', 'Initials': 'JL', 'LastName': 'Chen', 'Affiliation': 'Faculty of Nursing, University of California San Francisco, San Francisco, CA 94143, USA. Jyu-Lin.Chen@ucsf.edu.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cheung', 'Affiliation': 'Hong Kong Dietitians Association, Hong Kong, China. gclcheung@gmail.com.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China. paul.h.lee@polyu.edu.hk.'}]",International journal of environmental research and public health,['10.3390/ijerph14101178']
654,31594401,Can an app a day keep illiteracy away? Piloting the efficacy of Reading Doctor apps for preschoolers with developmental language disorder.,"Purpose:  This study investigated the efficacy of three Reading Doctor ®  (RD) apps in raising letter-sound aptitude, phoneme awareness and early decoding ability among children with heightened risk for reading difficulties due to developmental language disorder (DLD). Method:  Twenty-four 4-year-old children with DLD, identified through baseline speech-language assessments, in their final term of pre-school participated in this study. In the experimental condition, 14 children participated twice a week in three RD apps for 8 weeks. In the control condition, 10 children engaged in their usual pre-school programme inclusive of teacher-delivered small-group activities related to letters and sounds taught in a non-systematic and non-explicit fashion. Result:  No significant between-group differences were identified prior to the implementation of RD. Following instruction, pre-school children in the experimental condition performed significantly better than children in the control condition in phoneme blending ( p  < 0.001,  d =  1.86), phoneme segmentation ( p  < 0.001,  d =  1.15) and letter-sound recognition ( p<  0.001,  d =  1.92), as well as in the number of correct phoneme-grapheme conversions during early decoding attempts ( p =  0.025,  d =  1.08). Conclusion:  Initial evidence suggests that RD software may support code-based reading readiness among pre-school children with DLD prior to school entry.",2020,"Following instruction, pre-school children in the experimental condition performed significantly better than children in the control condition in phoneme blending ( p  < 0.001,  d =  1.86), phoneme segmentation ( p  < 0.001,  d =  1.15) and letter-sound recognition ( p<  0.001,  d =  1.92), as well as in the number of correct phoneme-grapheme conversions during early decoding attempts ( p =  0.025,  d =  1.08).  ","['preschoolers with developmental language disorder', 'pre-school children with DLD prior to school entry', '10 children engaged in their usual pre-school programme inclusive of', 'Method:  Twenty-four 4-year-old children with DLD, identified through baseline speech-language assessments, in their final term of pre-school participated in this study', 'children with heightened risk for reading difficulties due to developmental language disorder (DLD']","['three Reading Doctor ®  (RD', 'teacher-delivered small-group activities related to letters and sounds taught in a non-systematic and non-explicit fashion']","['letter-sound recognition', 'phoneme segmentation']","[{'cui': 'C0023014', 'cui_str': 'Speech or Language, Developmental Disorder'}, {'cui': 'C0424930', 'cui_str': 'Pre-school (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442803', 'cui_str': 'Heightened (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0220922', 'cui_str': 'systematics'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0700381', 'cui_str': 'Segmentation (qualifier value)'}]",14.0,0.0180509,"Following instruction, pre-school children in the experimental condition performed significantly better than children in the control condition in phoneme blending ( p  < 0.001,  d =  1.86), phoneme segmentation ( p  < 0.001,  d =  1.15) and letter-sound recognition ( p<  0.001,  d =  1.92), as well as in the number of correct phoneme-grapheme conversions during early decoding attempts ( p =  0.025,  d =  1.08).  ","[{'ForeName': 'Karyn L', 'Initials': 'KL', 'LastName': 'Carson', 'Affiliation': 'College of Education, Psychology and Social Work, Flinders University, Adelaide, Australia.'}]",International journal of speech-language pathology,['10.1080/17549507.2019.1667438']
655,28790131,A Team-Based Online Game Improves Blood Glucose Control in Veterans With Type 2 Diabetes: A Randomized Controlled Trial.,"OBJECTIVE


Rigorous evidence is lacking whether online games can improve patients' longer-term health outcomes. We investigated whether an online team-based game delivering diabetes self-management education (DSME) to patients via e-mail or mobile application (app) can generate longer-term improvements in hemoglobin A 1c  (HbA 1c ).
RESEARCH DESIGN AND METHODS


Patients ( n  = 456) on oral diabetes medications with HbA 1c  ≥58 mmol/mol were randomly assigned between a DSME game (with a civics booklet) and a civics game (with a DSME booklet). The 6-month games sent two questions twice weekly via e-mail or mobile app. Participants accrued points based on performance, with scores posted on leaderboards. Winning teams and individuals received modest financial rewards. Our primary outcome measure was HbA 1c  change over 12 months.
RESULTS


DSME game patients had significantly greater HbA 1c  reductions over 12 months than civics game patients (-8 mmol/mol [95% CI -10 to -7] and -5 mmol/mol [95% CI -7 to -3], respectively;  P  = 0.048). HbA 1c  reductions were greater among patients with baseline HbA 1c  >75 mmol/mol: -16 mmol/mol [95% CI -21 to -12] and -9 mmol/mol [95% CI -14 to -5] for DSME and civics game patients, respectively;  P  = 0.031.
CONCLUSIONS


Patients with diabetes who were randomized to an online game delivering DSME demonstrated sustained and meaningful HbA 1c  improvements. Among patients with poorly controlled diabetes, the DSME game reduced HbA 1c  by a magnitude comparable to starting a new diabetes medication. Online games may be a scalable approach to improve outcomes among geographically dispersed patients with diabetes and other chronic diseases.",2017,HbA 1c  reductions were greater among patients with baseline HbA 1c  >75 mmol/mol: -16,"['geographically dispersed patients with diabetes and other chronic diseases', 'Veterans With Type', 'Patients with diabetes', 'Patients ( n  = 456) on oral diabetes medications with HbA 1c  ≥58 mmol/mol', 'patients with poorly controlled diabetes', '2 Diabetes']","['mmol/mol ', 'online team-based game delivering diabetes self-management education (DSME) to patients via e-mail or mobile application (app', 'DSME game (with a civics booklet) and a civics game (with a DSME booklet', 'questions twice weekly via e-mail or mobile app']","['HbA 1c  change over 12 months', 'HbA 1c  reductions']","[{'cui': 'C4545472', 'cui_str': 'Disperse (transformation)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}]","[{'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.101762,HbA 1c  reductions were greater among patients with baseline HbA 1c  >75 mmol/mol: -16,"[{'ForeName': 'B Price', 'Initials': 'BP', 'LastName': 'Kerfoot', 'Affiliation': 'Veterans Affairs Boston Healthcare System, Boston, MA price.kerfoot@gmail.com.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Gagnon', 'Affiliation': 'Veterans Affairs Boston Healthcare System, Boston, MA.'}, {'ForeName': 'Graham T', 'Initials': 'GT', 'LastName': 'McMahon', 'Affiliation': 'Accreditation Council for Continuing Medical Education and Northwestern University, Chicago, IL.'}, {'ForeName': 'Jay D', 'Initials': 'JD', 'LastName': 'Orlander', 'Affiliation': 'Veterans Affairs Boston Healthcare System, Boston, MA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Kurgansky', 'Affiliation': 'Veterans Affairs Boston Healthcare System, Boston, MA.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Conlin', 'Affiliation': 'Veterans Affairs Boston Healthcare System, Boston, MA.'}]",Diabetes care,['10.2337/dc17-0310']
656,31568390,Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients: A Randomized Controlled Trial.,"BACKGROUND


New-onset diabetes is common after kidney transplantation, but the benefit of lifestyle intervention to improve glucose metabolism posttransplantation is unproven.
METHODS


We conducted a single-center, randomized controlled trial involving 130 nondiabetic kidney transplant recipients with stable function between 3 and 24 months post-transplantation. Participants were randomly assigned in a 1:1 ratio to receive active intervention (lifestyle advice delivered by renal dietitians using behavior change techniques) versus passive intervention (leaflet advice alone). Primary outcome was 6-month change in insulin secretion, insulin sensitivity, and disposition index. Secondary outcomes included patient-reported outcomes, cardiometabolic parameters, clinical outcomes, and safety endpoints.
RESULTS


Between August 17, 2015 and December 18, 2017, 130 individuals were recruited, of whom 103 completed the study (drop-out rate 20.8%). Active versus passive intervention was not associated with any change in glucose metabolism: insulin secretion (mean difference, -446; 95% confidence interval [CI], -3184 to 2292; P = 0.748), insulin sensitivity (mean difference, -0.45; 95% CI, -1.34 to 0.44; P = 0.319), or disposition index (mean difference, -940; 95% CI, -5655 to 3775; P = 0.693). Clinically, active versus passive lifestyle intervention resulted in reduced incidence of posttransplantation diabetes (7.6% versus 15.6%, respectively, P = 0.123), reduction in fat mass (mean difference, -1.537 kg; 95% CI, -2.947 to -0.127; P = 0.033), and improvement in weight (mean difference, -2.47 kg; 95% CI, -4.01 to -0.92; P = 0.002). No serious adverse events were noted.
CONCLUSIONS


Active lifestyle intervention led by renal dietitians did not improve surrogate markers of glucose metabolism. Further investigation is warranted to determine if clinical outcomes can be improved using this methodology.",2020,Active versus passive intervention was not associated with any change in glucose metabolism; insulin secretion (mean difference -446,"['130 nondiabetic kidney transplant recipients with stable function between 3-24 months post transplantation', 'Between August 17 2015 and December 18 2017, 130 individuals were recruited of whom 103 completed the study (drop-out rate 20.8', 'kidney allograft recipients (CAVIAR']","['active versus passive lifestyle intervention', 'active intervention (lifestyle advice delivered by renal dietitians using behaviour change techniques) versus passive intervention (leaflet advice alone']","['insulin sensitivity', 'six-month change in insulin secretion, insulin sensitivity and disposition index', 'reduced incidence of post transplantation diabetes', 'patient-reported outcomes, cardio-metabolic parameters, clinical outcomes and safety endpoints', 'disposition index', 'surrogate markers of glucose metabolism', 'glucose metabolism; insulin secretion', 'reduction in fat mass', 'weight', 'serious adverse events']","[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C2347573', 'cui_str': 'Caviar (substance)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0586938', 'cui_str': 'Renal dietitian (occupation)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0086589', 'cui_str': 'Surrogate Markers'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",130.0,0.460737,Active versus passive intervention was not associated with any change in glucose metabolism; insulin secretion (mean difference -446,"[{'ForeName': 'Kulli', 'Initials': 'K', 'LastName': 'Kuningas', 'Affiliation': 'Department of Nephrology and Transplantation, Queen Elizabeth Hospital, Edgbaston, Birmingham, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Driscoll', 'Affiliation': 'Department of Nutrition and Dietetics, Queen Elizabeth Hospital, Birmingham, United Kingdom.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Mair', 'Affiliation': 'Department of Nutrition and Dietetics, Queen Elizabeth Hospital, Birmingham, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Smith', 'Affiliation': 'Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dutton', 'Affiliation': 'Department of Nephrology and Transplantation, Queen Elizabeth Hospital, Edgbaston, Birmingham, United Kingdom.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Day', 'Affiliation': ""National Addiction Centre, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'And Adnan', 'Initials': 'AA', 'LastName': 'Sharif', 'Affiliation': 'Department of Nephrology and Transplantation, Queen Elizabeth Hospital, Edgbaston, Birmingham, United Kingdom.'}]",Transplantation,['10.1097/TP.0000000000002969']
657,28029852,Impact of a Mindfulness-Based Weight-Loss Intervention on Sleep Quality Among Adults with Obesity: Data from the SHINE Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVE


Sleep disturbance is a common problem among adults with obesity. Mindfulness interventions have been shown to improve sleep quality in various populations but have not been investigated in adults with obesity. The aim of this study was to compare the effects of a mindfulness-based weight-loss intervention with an active control on self-reported sleep quality among adults with obesity.
METHOD


This study was a secondary analysis of a randomized controlled trial and included 194 adults with a body mass index in the range 30-45 kg/m 2 . The treatment intervention included mindfulness-based eating and stress-management practices, and the active control intervention included training in progressive muscle relaxation (PMR). Both groups received identical diet and exercise guidelines in 17 group sessions conducted over 5.5 months that were matched for time, attention, and social support. The primary outcome of this analysis was between-group change in self-reported sleep quality, which was assessed using the Pittsburgh Sleep Quality Index (PSQI) global score at baseline and at 6, 12, and 18 months.
RESULTS


Between-group differences in mean PSQI change scores in the mindfulness group (n = 100) compared to the control group (n = 94) were -0.27 (-0.68, 1.22; p = 0.58) at 6 months, -0.57 (-0.35, 1.50; p = 0.22) at 12 months, and -0.50 (-0.53, 1.53; p = 0.34) at 18 months, all in the direction of more sleep improvement in the mindfulness group but none reaching statistical significance. In the mindfulness group, average weekly minutes of meditation practice time was associated with improved sleep quality from baseline to 6 months.
CONCLUSIONS


No statistically significant evidence was found that a weight-loss program that incorporates mindfulness improves self-reported sleep quality compared to a control diet/exercise intervention that included PMR. Within the mindfulness group, average weekly minutes of mindfulness practice was associated with improved sleep quality.",2017,No statistically significant evidence was found that a weight-loss program that incorporates mindfulness improves self-reported sleep quality compared to a control diet/exercise intervention that included PMR.,"['Adults with Obesity', 'adults with obesity', '194 adults with a body mass index in the range 30-45\u2009kg/m 2 ']","['identical diet and exercise guidelines', 'mindfulness-based weight-loss intervention', 'Mindfulness-Based Weight-Loss Intervention', 'mindfulness-based eating and stress-management practices, and the active control intervention included training in progressive muscle relaxation (PMR']","['Pittsburgh Sleep Quality Index (PSQI) global score', 'Sleep Quality', 'self-reported sleep quality', 'sleep improvement', 'mean PSQI change scores', 'sleep quality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}]","[{'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",194.0,0.0540476,No statistically significant evidence was found that a weight-loss program that incorporates mindfulness improves self-reported sleep quality compared to a control diet/exercise intervention that included PMR.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Adler', 'Affiliation': '1 UCSF Osher Center for Integrative Medicine, San Francisco, CA.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Dhruva', 'Affiliation': '1 UCSF Osher Center for Integrative Medicine, San Francisco, CA.'}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Moran', 'Affiliation': '1 UCSF Osher Center for Integrative Medicine, San Francisco, CA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Daubenmier', 'Affiliation': '1 UCSF Osher Center for Integrative Medicine, San Francisco, CA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Acree', 'Affiliation': '1 UCSF Osher Center for Integrative Medicine, San Francisco, CA.'}, {'ForeName': 'Elissa S', 'Initials': 'ES', 'LastName': 'Epel', 'Affiliation': '1 UCSF Osher Center for Integrative Medicine, San Francisco, CA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bacchetti', 'Affiliation': '3 Department of Epidemiology and Biostatistics, UCSF Osher Center for Integrative Medicine , San Francisco, CA.'}, {'ForeName': 'Aric A', 'Initials': 'AA', 'LastName': 'Prather', 'Affiliation': '4 Department of Psychiatry, UCSF Osher Center for Integrative Medicine , San Francisco, CA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Mason', 'Affiliation': '1 UCSF Osher Center for Integrative Medicine, San Francisco, CA.'}, {'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Hecht', 'Affiliation': '1 UCSF Osher Center for Integrative Medicine, San Francisco, CA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2016.0141']
658,28060186,Acupuncture for Pain in Chronic Pancreatitis: A Single-Blinded Randomized Crossover Trial.,"OBJECTIVES


Many patients with painful chronic pancreatitis (CP) have insufficient effect of treatment, and the prevalence of adverse effects is high. Consequently, alternatives to conventional management are needed. We aimed to study the effect of acupuncture in painful CP.
METHODS


This was a prospective, single-blinded, randomized crossover trial. Fifteen patients with CP were assigned to a session of acupuncture followed by sham stimulation or vice versa. Patients rated clinical pain scores daily on a 0 to 10 visual analogue scale (VAS) and completed the Patient Global Impression of Change. For mechanistic linkage, resting state electroencephalograms were recorded and quantified by spectral power analysis to explore effects on central pain processing.
RESULTS


Acupuncture, compared with sham stimulation, caused more pain relief (2.0 ± 1.5 VAS vs 0.7 ± 0.8 VAS; P = 0.009). The effect, however, was short, and after 1-week follow-up, there was no difference in clinical pain scores between groups (P = 1.0) or the rating of Patient Global Impression of Change (P = 0.8). Electroencephalogram spectral power distributions between sham and acupuncture were comparable between groups (all P > 0.6).
CONCLUSIONS


The study presents proof-of-concept for the analgesic effect of acupuncture in pancreatic pain. Although the effect was short lasting, the framework may be used to conceptualize future trials of acupuncture in visceral pain.",2017,"RESULTS


Acupuncture, compared with sham stimulation, caused more pain relief (2.0 ± 1.5 VAS vs 0.7 ± 0.8 VAS; P = 0.009).","['Fifteen patients with CP', 'painful CP', 'Chronic Pancreatitis', 'patients with painful chronic pancreatitis (CP', 'pancreatic pain']","['Acupuncture', 'acupuncture', 'acupuncture followed by sham stimulation or vice versa']","['clinical pain scores', 'clinical pain scores daily on a 0 to 10 visual analogue scale (VAS', 'pain relief', 'Electroencephalogram spectral power distributions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0149521', 'cui_str': 'Pancreatitis, Chronic'}, {'cui': 'C0522071', 'cui_str': 'Pancreatic pain (finding)'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}]",15.0,0.365537,"RESULTS


Acupuncture, compared with sham stimulation, caused more pain relief (2.0 ± 1.5 VAS vs 0.7 ± 0.8 VAS; P = 0.009).","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Juel', 'Affiliation': 'From the *Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark; †Istituto Paracelso; ‡Department of Anatomic, Histologic, Forensic Medicine and Locomotor System Sciences, Faculty of Pharmacy and Medicine, Sapienza University; §Department of Neurology, Pediatric Hospital Bambino Gesù, Rome, Italy; and ∥Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Liguori', 'Affiliation': ''}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Liguori', 'Affiliation': ''}, {'ForeName': 'Jakob L', 'Initials': 'JL', 'LastName': 'Poulsen', 'Affiliation': ''}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Valeriani', 'Affiliation': ''}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Graversen', 'Affiliation': ''}, {'ForeName': 'Søren S', 'Initials': 'SS', 'LastName': 'Olesen', 'Affiliation': ''}, {'ForeName': 'Asbjørn M', 'Initials': 'AM', 'LastName': 'Drewes', 'Affiliation': ''}]",Pancreas,['10.1097/MPA.0000000000000749']
659,28421384,The efficacy of Guolin-Qigong on the body-mind health of Chinese women with breast cancer: a randomized controlled trial.,"PURPOSE


This study was to evaluate the efficacy of a complementary Chinese treatment modality Guolin-Qigong (GLQG) for patients with breast cancer on the body-mind health.
METHODS


A randomized controlled clinical trial was conducted among 158 women with breast cancer. Subjects were randomized to receive GLQG (test group) versus a physical stretching program (control group) following conventional treatment for breast cancer. GLQG and stretching interventions were performed twice a week over 24 weeks. The primary outcome was the change in quality of life (QoL). Secondary outcome measures included anxiety, depression, and clinical indicators. All participants were assessed at four time-points, at the beginning of the study (T1), after 12 weeks of the intervention (T2), immediately after 24-week intervention (T3), and at 48-week follow-up visit (T4).
RESULTS


Improvements in QoL were evident in both groups but the test group fared better than the control group at the 12th week (P < 0.01) and particularly in emotional well-being (P < 0.01) and breast cancer-specific well-being (P < 0.001). The test group showed an improvement in anxiety levels (P < 0.01), whereas the control group showed improvements in depression (P < 0.05) but there was no significant difference between groups (P > 0.05). Both groups showed improvements in immunological function and the test group fared better than the control in TNF-α levels (P < 0.05). The results in subjects who practiced more than 4 times and 6 h per week were similar to that of all subjects; however, the improvement in anxiety in the GLQG group was more obvious. There are positive correlations between QoL and anxiety and depression.
CONCLUSIONS


Both GLQG and physical stretching are beneficial during recovery following breast cancer. GLQC was more effective in terms of Qol improvements than physical stretching. Both programs brought improvements in anxiety or depression but had were comparable. GLQC group had a greater effect on immunological function than physical exercise.",2017,"RESULTS


Improvements in QoL were evident in both groups but the test group fared better than the control group at the 12th week (P < 0.01) and particularly in emotional well-being (P < 0.01) and breast cancer-specific well-being (P ","['patients with breast cancer on the body-mind health', 'Chinese women with breast cancer', '158 women with breast cancer']","['GLQG and stretching interventions', 'complementary Chinese treatment modality Guolin-Qigong (GLQG', 'GLQG and physical stretching', 'Guolin-Qigong', 'GLQC', 'GLQG', 'physical stretching program (control group) following conventional treatment']","['anxiety, depression, and clinical indicators', 'QoL and anxiety and depression', 'depression', 'anxiety or depression', 'anxiety levels', 'change in quality of life (QoL', 'QoL', 'TNF-α levels', 'immunological function', 'anxiety', 'breast cancer-specific well-being (P']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282077', 'cui_str': ""Ch'i Kung""}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034380'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",158.0,0.0495292,"RESULTS


Improvements in QoL were evident in both groups but the test group fared better than the control group at the 12th week (P < 0.01) and particularly in emotional well-being (P < 0.01) and breast cancer-specific well-being (P ","[{'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Jieshu', 'Initials': 'J', 'LastName': 'You', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Wing T Y', 'Initials': 'WTY', 'LastName': 'Loo', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Youzhi', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Sit', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Meikuen', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Xia', 'Affiliation': ""School of Public Health, Peking University, Beijing, 100191, People's Republic of China.""}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Neng', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Lixing', 'Initials': 'L', 'LastName': 'Lao', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong. abchen@hku.hk.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-017-1576-7']
660,28213841,Sitagliptin down-regulates retinol-binding protein 4 and reduces insulin resistance in gestational diabetes mellitus: a randomized and double-blind trial.,"Gestational diabetes mellitus (GDM) is a condition that affects increasing number of pregnant women worldwide. Sitagliptin was reported to alleviate symptoms of type 2 diabetes mellitus by reducing serum levels of retinol-binding protein 4 (RBP-4). We investigated the effectiveness of sitagliptin on insulin sensitivity parameters in GDM patients. Pregnant GDM women in the 2nd trimester were recruited for this study. Participants were then assigned randomly to sitagliptin treatment group or placebo treatment group, and administered sitagliptin or placebo daily for 16 weeks. Glucose and insulin profiles, as well as serum RBP-4 level, were measured at both baseline and end of the study. After 16 weeks of treatment, participants in the STL group exhibited significantly improved levels of fasting plasma glucose and serum insulin, homeostasis model of assessment of β cell function (HOMA-β) and insulin resistance (HOMA-IR), compared with those in the placebo group. Serum levels of RBP-4 were also markedly decreased in the sitagliptin treatment group, and more importantly it was positively correlated with improved insulin resistance parameters. Our study supports a potentially promising role of sitagliptin in improving insulin resistance by decreasing RBP-4 in GDM-affected women.",2017,"After 16 weeks of treatment, participants in the STL group exhibited significantly improved levels of fasting plasma glucose and serum insulin, homeostasis model of assessment of β cell function (HOMA-β) and insulin resistance (HOMA-IR), compared with those in the placebo group.","['Gestational diabetes mellitus (GDM', 'GDM patients', 'Pregnant GDM women in the 2nd trimester', 'GDM-affected women', 'gestational diabetes mellitus']","['placebo', 'Sitagliptin', 'sitagliptin or placebo', 'sitagliptin treatment group or placebo', 'sitagliptin']","['Glucose and insulin profiles, as well as serum RBP-4 level', 'insulin resistance parameters', 'Serum levels of RBP-4', 'insulin sensitivity parameters', 'levels of fasting plasma glucose and serum insulin, homeostasis model of assessment of β cell function (HOMA-β) and insulin resistance (HOMA-IR']","[{'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032980', 'cui_str': 'Midtrimester'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.192084,"After 16 weeks of treatment, participants in the STL group exhibited significantly improved levels of fasting plasma glucose and serum insulin, homeostasis model of assessment of β cell function (HOMA-β) and insulin resistance (HOMA-IR), compared with those in the placebo group.","[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Qingdao Municipal Hospital, Rd. Donghaizhong #5, Shinan District, Qingdao, 266001, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Qingdao Municipal Hospital, Rd. Donghaizhong #5, Shinan District, Qingdao, 266001, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Ning', 'Affiliation': 'Qingdao Municipal Hospital, Rd. Donghaizhong #5, Shinan District, Qingdao, 266001, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Qingdao Municipal Hospital, Rd. Donghaizhong #5, Shinan District, Qingdao, 266001, China. sunhongsdqd@126.com.'}, {'ForeName': 'Xianghong', 'Initials': 'X', 'LastName': 'Ji', 'Affiliation': 'Qingdao Municipal Hospital, Rd. Donghaizhong #5, Shinan District, Qingdao, 266001, China. xianghongjig@126.com.'}]",Metabolic brain disease,['10.1007/s11011-017-9958-7']
661,28158982,Study protocol; Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism - a randomised placebo controlled Trial (TRUST).,"BACKGROUND


Subclinical hypothyroidism (SCH) is a common condition in elderly people, defined as elevated serum thyroid-stimulating hormone (TSH) with normal circulating free thyroxine (fT4). Evidence is lacking about the effect of thyroid hormone treatment. We describe the protocol of a large randomised controlled trial (RCT) of Levothyroxine treatment for SCH.
METHODS


Participants are community-dwelling subjects aged ≥65 years with SCH, diagnosed by elevated TSH levels (≥4.6 and ≤19.9 mU/L) on a minimum of two measures ≥ three months apart, with fT4 levels within laboratory reference range. The study is a randomised double-blind placebo-controlled parallel group trial, starting with levothyroxine 50 micrograms daily (25 micrograms in subjects <50Kg body weight or known coronary heart disease) with titration of dose in the active treatment group according to TSH level, and a mock titration in the placebo group. The primary outcomes are changes in two domains (hypothyroid symptoms and fatigue / vitality) on the thyroid-related quality of life questionnaire (ThyPRO) at one year. The study has 80% power (at p = 0.025, 2-tailed) to detect a change with levothyroxine treatment of 3.0% on the hypothyroid scale and 4.1% on the fatigue / vitality scale with a total target sample size of 750 patients. Secondary outcomes include general health-related quality of life (EuroQol), fatal and non-fatal cardiovascular events, handgrip strength, executive cognitive function (Letter Digit Coding Test), basic and instrumental activities of daily living, haemoglobin, blood pressure, weight, body mass index and waist circumference. Patients are monitored for specific adverse events of interest including incident atrial fibrillation, heart failure and bone fracture.
DISCUSSION


This large multicentre RCT of levothyroxine treatment of subclinical hypothyroidism is powered to detect clinically relevant change in symptoms / quality of life and is likely to be highly influential in guiding treatment of this common condition.
TRIAL REGISTRATION


Clinicaltrials.gov NCT01660126 ; registered 8th June 2012.",2017,"This large multicentre RCT of levothyroxine treatment of subclinical hypothyroidism is powered to detect clinically relevant change in symptoms / quality of life and is likely to be highly influential in guiding treatment of this common condition.
","['Untreated older adults with Subclinical hypothyroidism - a randomised', 'Participants are community-dwelling subjects aged ≥65\xa0years with SCH, diagnosed by elevated TSH levels (≥4.6 and ≤19.9\xa0mU/L) on a minimum of two measures\u2009≥\u2009three months apart, with fT4 levels within laboratory reference range', 'subjects <50Kg body weight or known coronary heart disease) with titration of dose in the active treatment group according to TSH level, and a mock titration in the placebo group']","['Thyroid hormone Replacement', 'placebo', 'levothyroxine', 'Levothyroxine']","['fatigue / vitality scale', 'incident atrial fibrillation, heart failure and bone fracture', 'changes in two domains (hypothyroid symptoms and fatigue / vitality) on the thyroid-related quality of life questionnaire (ThyPRO', 'general health-related quality of life (EuroQol), fatal and non-fatal cardiovascular events, handgrip strength, executive cognitive function (Letter Digit Coding Test), basic and instrumental activities of daily living, haemoglobin, blood pressure, weight, body mass index and waist circumference']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism (disorder)'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0439342', 'cui_str': 'uU/mL'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0086715', 'cui_str': 'Normal Range'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0562577', 'cui_str': 'Mocking (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4522017', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1881373', 'cui_str': ""L-3,5,3',5'-Tetraiodothyronine""}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0222045'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0589089', 'cui_str': 'Executive cognitive functions (observable entity)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]",,0.581707,"This large multicentre RCT of levothyroxine treatment of subclinical hypothyroidism is powered to detect clinically relevant change in symptoms / quality of life and is likely to be highly influential in guiding treatment of this common condition.
","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stott', 'Affiliation': 'Geriatric Medicine, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK. David.J.Stott@glasgow.ac.uk.'}, {'ForeName': 'Jacobijn', 'Initials': 'J', 'LastName': 'Gussekloo', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Kearney', 'Affiliation': 'Department of Epidemiology and Public Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Rudi G J', 'Initials': 'RG', 'LastName': 'Westendorp', 'Affiliation': 'Leyden Academy on Vitality and Ageing, Leiden, Netherlands.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Mooijaart', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Kean', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': 'Quinn', 'Affiliation': 'Geriatric Medicine, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Hendry', 'Affiliation': 'Geriatric Medicine, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Du Puy', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Wendy P J', 'Initials': 'WP', 'LastName': 'Den Elzen', 'Affiliation': 'Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Rosalinde K E', 'Initials': 'RK', 'LastName': 'Poortvliet', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Jan W A', 'Initials': 'JW', 'LastName': 'Smit', 'Affiliation': 'Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Olaf M', 'Initials': 'OM', 'LastName': 'Dekkers', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Blum', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Tinh-Hai', 'Initials': 'TH', 'LastName': 'Collet', 'Affiliation': 'Service of Endocrinology Diabetes and Metabolism, University Hospital of Laussanne, Lausanne, Switzerland.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'McCarthy', 'Affiliation': 'School of Nursing and Midwifery, University College Cork, Cork, Ireland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hurley', 'Affiliation': 'Department of Epidemiology and Public Health and Clinical Research Facility, University College Cork, Cork, Ireland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'School of Pharmacy, University College Cork, Cork, Ireland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Browne', 'Affiliation': 'Department of Epidemiology and Public Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Torquil', 'Initials': 'T', 'LastName': 'Watt', 'Affiliation': 'Department of Internal Medicine, Copenhagen University Hospital Herlev, Gentofte, Denmark.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Bauer', 'Affiliation': 'Department of Medicine, University of California, San Francisco, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}]",BMC endocrine disorders,['10.1186/s12902-017-0156-8']
662,32425482,Gall Bladder Empyema: Early Cholecystectomy during the Index Admission Improves Outcomes.,"Objectives


We aim to evaluate our policy of index admission management of gall bladder empyema and the effect of the timing of surgery on the outcomes.
Methods


We analyzed a series of 5400 laparoscopic cholecystectomies. Data were collected prospectively over 26 y. Patients were divided into two groups: group 1, intervention within 72 h, and group 2, intervention after 72 h of admission. We had a policy of intention to treat during the index admission, but delays sometimes occurred because of late referral, a need to optimize patients, availability of theater time, or the biliary surgeon being on leave. The groups were then compared with regard to the duration of surgery, the difficulty grading, complications, hospital stay, and conversion rate.
Results


A total of 372 patients were included; 160 (43%) operated on within 72 h (group 1) and 212 (57%) after 72 h (group 2). There was no statistically significant difference between the two groups with regard to the operation time, conversion rate, and complications rate. The difference in total hospital stay was, however, statistically significant.
Conclusion


Surgical management of empyema should be offered as soon as possible after admission as with any acute cholecystitis. Surgery carried out after 72 h of admission is only associated with longer hospital stay but no statistically significant differences in other outcome parameters. In the presence of specialist expertise, fitness for surgery should be the determining factor of whether or not to offer surgery to these patients, regardless of the interval since their admission.",2020,"There was no statistically significant difference between the two groups with regard to the operation time, conversion rate, and complications rate.","['5400 laparoscopic cholecystectomies', 'Gall Bladder Empyema', 'A total of 372 patients were included; 160 (43%) operated on within 72 h (group 1) and 212 (57%) after 72 h (group 2']",[],"['difficulty grading, complications, hospital stay, and conversion rate', 'longer hospital stay', 'operation time, conversion rate, and complications rate', 'total hospital stay']","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0014012', 'cui_str': 'Empyema of gallbladder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]",[],"[{'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",372.0,0.051755,"There was no statistically significant difference between the two groups with regard to the operation time, conversion rate, and complications rate.","[{'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'El Zanati', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Ahmad H M', 'Initials': 'AHM', 'LastName': 'Nassar', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Zino', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Katbeh', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Hwei Jene', 'Initials': 'HJ', 'LastName': 'Ng', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Abdellatif', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2020.00015']
663,32414580,"Osmotherapy for malignant cerebral edema in a phase 2 prospective, double blind, randomized, placebo-controlled study of IV glibenclamide.","BACKGROUND/OBJECTIVE


Malignant edema can be a life-threatening complication of large hemispheric infarction (LHI), and is often treated with osmotherapy. In this exploratory analysis of data from the GAMES-RP study, we hypothesized that patients receiving osmotherapy had symptomatic cerebral edema, and that treatment with intravenous (IV) glibenclamide would modify osmotherapy use as compared with placebo.
METHODS


GAMES-RP was a phase 2 multi-center prospective, double blind, randomized, placebo-controlled study in LHI. Patients were randomized to IV glibenclamide (e.g. IV glyburide) or placebo. Cerebral edema therapies included osmotherapy and/or decompressive craniectomy at the discretion of the treating team. Total bolus osmotherapy dosing was quantified by ""osmolar load"". Radiographic edema was defined by dichotomizing midline shift at 24 h. Clinical changes were defined as any increase in NIHSS1a.
RESULTS


Osmotherapy was administered to 40 of the 77 patients at a median of 39 [27-55] h after stroke onset. The median baseline DWI lesion volume was significantly larger in the osmotherapy treated group (167 [146-211] mL v. 139 [112-170] mL; P=0.046). Adjudicated malignant edema (75% v. 16%; P<0.001) was more common in the osmotherapy treated group. There were no differences in the proportion of patients receiving osmotherapy or the median total osmolar load between treatment arms. Most patients (76%) had a decrease in consciousness (NIHSS item 1A ≥1) on the day they began receiving osmotherapy.
CONCLUSIONS


In the GAMES-RP trial, osmolar therapies were most often administered in response to clinical symptoms of decreased consciousness. However, the optimal timing of administration and impact on outcome after LHI have yet to be defined.",2020,Adjudicated malignant edema (75% v. 16%; P<0.001) was more common in the osmotherapy treated group.,[],"['intravenous (IV) glibenclamide', 'Osmotherapy', 'osmotherapy and/or decompressive craniectomy', 'glibenclamide (e.g. IV glyburide) or placebo', 'glibenclamide', 'placebo']","['NIHSS1a', 'median baseline DWI lesion volume', 'symptomatic cerebral edema', 'consciousness (NIHSS item 1A ≥1', 'Radiographic edema', 'median total osmolar load', 'Adjudicated malignant edema']",[],"[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C4759300', 'cui_str': 'Osmotherapy'}, {'cui': 'C2717817', 'cui_str': 'Decompressive craniectomy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0598801', 'cui_str': 'Diffusion weighted magnetic resonance imaging'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0006114', 'cui_str': 'Cerebral edema'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439351', 'cui_str': 'osmol/L'}, {'cui': 'C0017105', 'cui_str': 'Gas gangrene'}]",,0.420017,Adjudicated malignant edema (75% v. 16%; P<0.001) was more common in the osmotherapy treated group.,"[{'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Hinson', 'Affiliation': 'Departments of Neurology and Emergency Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, CR-127, Portland, OR 97239, USA. Electronic address: hinson@ohsu.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Molyneaux', 'Affiliation': 'Department of Neurology, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: molyneauxbj@upmc.edu.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'von Kummer', 'Affiliation': 'Department of Neuroradiology, Universitätsklinikum Carl Gustav Carus, Dresden, Germany. Electronic address: Ruediger.vonKummer@uniklinikum-dresden.de.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Demchuk', 'Affiliation': 'Calgary Stroke Program, Department of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada. Electronic address: ademchuk@ucalgary.ca.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Romero', 'Affiliation': 'Division of Neuroradiology, Department of Radiology, Massachusetts General Hospital, Boston, MA, USA. Electronic address: JMROMERO@mgh.harvard.edu.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Taylor Kimberly', 'Affiliation': 'Department of Neurology, Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA. Electronic address: WTKIMBERLY@mgh.harvard.edu.'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Sheth', 'Affiliation': 'Division of Neurocritical Care and Emergency Neurology, Yale New Haven Hospital, New Haven, CT, USA. Electronic address: kevin.sheth@yale.edu.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104916']
664,32414888,Deep neuromuscular block improves angiographic image quality during endovascular coiling of unruptured cerebral aneurysm: a randomized clinical trial.,"BACKGROUND


Neuromuscular block (NMB) used during general anesthesia induces transient skeletal muscle paralysis, but patient movements during endovascular coiling still occur to some degree. Compared with moderate NMB, deep NMB may further improve the intervention condition during endovascular coiling for unruptured cerebral aneurysms; however, little research has focused on the angiographic image quality.
METHODS


This prospective, randomized, double-blind clinical trial included 58 patients treated for unruptured cerebral aneurysms with endovascular coiling under general anesthesia. Patients were randomly allocated to either the deep NMB group (post-tetanic count 1 or 2) or the moderate NMB group (train-of-four 1 or 2). The primary outcome was the proportion of patients with a satisfactory intervention condition assessed by surgeons after the procedure using a 5-point intervention condition rating scale (ICRS) from 1 (unable to obtain image) to 5 (optimal); ICRS 5 was defined as satisfactory.
RESULTS


There were significantly more cases of satisfactory intervention condition in the deep NMB group than in the moderate NMB group (82.1% vs 51.7%, p=0.015). The frequency of each ICRS score was significantly different between the groups (ICRS 5/4/3/2/1: 23/5/0/0/0 vs 15/9/2/3/0, p=0.035). The incidence of major patient movement requiring rescue muscle relaxant was 10.3% in the moderate NMB group and 0% in the deep NMB group (p=0.237). The drugs used to maintain hemodynamic stability were not significantly different between the two groups.
CONCLUSIONS


Deep NMB improves the intervention condition during endovascular coiling by improving the image quality.",2020,"The frequency of each ICRS score was significantly different between the groups (ICRS 5/4/3/2/1: 23/5/0/0/0 vs 15/9/2/3/0, p=0.035).","['58 patients treated for unruptured cerebral aneurysms with endovascular coiling under general anesthesia', 'endovascular coiling of unruptured cerebral aneurysm']","['Deep neuromuscular block', 'Deep NMB', 'Neuromuscular block (NMB', 'deep NMB group (post-tetanic count 1 or 2) or the moderate NMB']","['hemodynamic stability', 'angiographic image quality', 'proportion of patients with a satisfactory intervention condition assessed by surgeons after the procedure using a 5-point intervention condition rating scale (ICRS', 'frequency of each ICRS score', 'satisfactory intervention condition', 'incidence of major patient movement requiring rescue muscle relaxant']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0155730', 'cui_str': 'Cerebral aneurysm, nonruptured'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0235062', 'cui_str': 'Induction of neuromuscular blockade'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0428701', 'cui_str': 'Post-tetanic count'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0026827', 'cui_str': 'Decreased muscle tone'}]",58.0,0.137455,"The frequency of each ICRS score was significantly different between the groups (ICRS 5/4/3/2/1: 23/5/0/0/0 vs 15/9/2/3/0, p=0.035).","[{'ForeName': 'Bo Young', 'Initials': 'BY', 'LastName': 'Kim', 'Affiliation': 'Graduate School, Department of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Sung Hoon', 'Initials': 'SH', 'LastName': 'Chung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Seong-Joo', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Sung-Hee', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'O-Ki', 'Initials': 'OK', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurosurgery, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Chung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea anesing1@snu.ac.kr.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2020-015947']
665,29343078,Quality of life among HIV-infected individuals failing first-line antiretroviral therapy in resource-limited settings.,"We evaluated health-related quality of life (QoL) in HIV infection participants with virologic failure (VF) on first-line antiretroviral therapy (ART) in 9 resource-limited settings (RLS). ACTG SF-21 was completed by 512 participants at A5273 study entry; 8 domains assessed: general health perceptions (GHP), physical functioning (PF), role functioning (RF), social functioning (SF), cognitive functioning (CF), pain (P), mental health (MH), and energy/fatigue (E/F); each was scored between 0 (worst) to 100 (best). Mean QoL scores ranged from 67 (GHP) to 91 (PF, SF, CF). QoL varied by country; high VL and low CD4 were associated with worse QoL in most domains, except RF (VL only), SF (CD4 only) and CF (neither). Number of comorbidities, BMI and history of AIDS were associated with some domains. Relationships between QoL and VL varied among countries for all domains. The association of worse disease status with worse QoL may reflect low QoL when ART was initiated and/or deterioration associated with VF.",2018,"QoL varied by country; high VL and low CD4 were associated with worse QoL in most domains, except RF (VL only), SF (CD4 only) and CF (neither).","['HIV infection participants with virologic failure (VF) on first-line antiretroviral therapy (ART) in 9 resource-limited settings (RLS', 'HIV-infected individuals failing first-line antiretroviral therapy in resource-limited settings']",[],"['general health perceptions (GHP), physical functioning (PF), role functioning (RF), social functioning (SF), cognitive functioning (CF), pain (P), mental health (MH), and energy/fatigue (E/F', 'health-related quality of life (QoL', 'Number of comorbidities, BMI and history of AIDS', 'Quality of life', 'Mean QoL scores']","[{'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C1699206', 'cui_str': 'Virologic failure'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0150269', 'cui_str': 'Limit setting (procedure)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",512.0,0.0555239,"QoL varied by country; high VL and low CD4 were associated with worse QoL in most domains, except RF (VL only), SF (CD4 only) and CF (neither).","[{'ForeName': 'Thiago S', 'Initials': 'TS', 'LastName': 'Torres', 'Affiliation': 'a Center for Biostatistics in AIDS Research , Harvard T.\xa0H.\xa0Chan School of Public Health , Boston , MA , USA.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Harrison', 'Affiliation': 'a Center for Biostatistics in AIDS Research , Harvard T.\xa0H.\xa0Chan School of Public Health , Boston , MA , USA.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'La Rosa', 'Affiliation': 'c Asociación Civil Impacta Salud y Educación , Lima , Peru.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lavenberg', 'Affiliation': 'a Center for Biostatistics in AIDS Research , Harvard T.\xa0H.\xa0Chan School of Public Health , Boston , MA , USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'a Center for Biostatistics in AIDS Research , Harvard T.\xa0H.\xa0Chan School of Public Health , Boston , MA , USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Safren', 'Affiliation': 'd Department of Psychology , University of Miami , Miami , FL , USA.'}, {'ForeName': 'McNeil', 'Initials': 'M', 'LastName': 'Ngongondo', 'Affiliation': 'a Center for Biostatistics in AIDS Research , Harvard T.\xa0H.\xa0Chan School of Public Health , Boston , MA , USA.'}, {'ForeName': 'Selvamuthu', 'Initials': 'S', 'LastName': 'Poongulali', 'Affiliation': 'f YRGCARE Medical Centre, VHS , Chennai , India.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Matoga', 'Affiliation': 'e UNC Project Lilongwe , Lilongwe , Malawi.'}, {'ForeName': 'Wadzanai', 'Initials': 'W', 'LastName': 'Samaneka', 'Affiliation': 'g Department of Medicine , University of Zimbabwe-University of California Collaborative Research Programme , Harare , Zimbabwe.'}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Collier', 'Affiliation': 'h Department of Medicine , University of Washington , Seattle , WA , USA ; for AIDS Clinical Trials Group (ACTG) A5273 Study Group.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hughes', 'Affiliation': 'a Center for Biostatistics in AIDS Research , Harvard T.\xa0H.\xa0Chan School of Public Health , Boston , MA , USA.'}]",AIDS care,['10.1080/09540121.2018.1427207']
666,31907774,Home-Based Physical Activity and Diet Intervention to Improve Physical Function in Advanced Liver Disease: A Randomized Pilot Trial.,"INTRODUCTION


A decline in physical function is highly prevalent and a poor prognostic factor in cirrhosis. We assessed the benefits of a home-based physical activity program (HB-PAP) in patients with cirrhosis with a randomized pilot trial.
METHODS


All participants received a personal activity tracker to monitor daily activities and were given 12 g/day of an essential amino acid supplement. The HB-PAP intervention consisted of biweekly counseling sessions to increase physical activity for 12 weeks. Six-minute walk test (6MWT) and cardiopulmonary exercise testing (CPET) assessed changes in aerobic fitness. Different anthropometric measuring tools were used for skeletal muscle and adiposity assessment.
RESULTS


Seventeen patients (60% male; 29% nonalcoholic steatohepatitis/cryptogenic, 29% hepatitis C, 24% alcohol, 18% other) were randomized, 9 to HB-PAP group. There were no significant differences in MELD-sodium between HB-PAP and controls at baseline or after the 12-week intervention. By the end of study, there was a significant between-group difference in daily step count favoring the active group (2627 [992-4262], p = 0.001), with less sedentary patients in the active group (33-17% vs. 25-43%, p = 0.003). The 6MWT improved in the HB-PAP group (423 ± 26 m vs. 482 ± 35 m), while the controls had a nonsignificant drop (418 ± 26 m vs. 327 ± 74 m) with a significant between-group difference. CPET did not change. Other than an improvement in psoas muscle index, there were no differences in anthropometry, or in quality of life.
CONCLUSIONS


HB-PAP maintained physical performance and improved aerobic fitness according to 6MWT but not CPET, supporting the use of personal activity trackers to monitor/guide home-based prehabilitation programs in cirrhosis.",2020,"Other than an improvement in psoas muscle index, there were no differences in anthropometry, or in quality of life.
","['patients with cirrhosis with a randomized pilot trial', 'Seventeen patients (60% male; 29% nonalcoholic steatohepatitis/cryptogenic, 29% hepatitis C, 24% alcohol, 18% other) were randomized, 9 to HB-PAP group', 'Advanced Liver Disease']","['personal activity tracker to monitor daily activities and were given 12\xa0g/day of an essential amino acid supplement', 'CPET', 'home-based physical activity program (HB-PAP', 'Six-minute walk test (6MWT) and cardiopulmonary exercise testing (CPET', 'Home-Based Physical Activity and Diet Intervention']","['6MWT', 'psoas muscle index', 'quality of life', 'physical activity', 'daily step count', 'MELD-sodium', 'aerobic fitness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin) (qualifier value)'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}]","[{'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1318183', 'cui_str': '12G'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0002525', 'cui_str': 'Amino Acids, Essential'}, {'cui': 'C0055954', 'cui_str': 'CPET'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0085221', 'cui_str': 'Psoas Muscles'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034380'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}]",,0.064779,"Other than an improvement in psoas muscle index, there were no differences in anthropometry, or in quality of life.
","[{'ForeName': 'Hui Wei', 'Initials': 'HW', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Thomas E. Starzl Transplantation Institute, University of Pittsburgh Medical Center, 3471 Fifth Avenue, Suite 201, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Arny', 'Initials': 'A', 'LastName': 'Ferrando', 'Affiliation': 'Department of Geriatrics, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'White', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Dennis', 'Affiliation': 'Department of Geriatrics, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Pauly', 'Affiliation': 'Liver Transplant Program, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Sanghee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Geriatrics, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Thaddeus', 'Initials': 'T', 'LastName': 'Bartter', 'Affiliation': 'Division of Pulmonary Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Dunn', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Thomas E. Starzl Transplantation Institute, University of Pittsburgh Medical Center, 3471 Fifth Avenue, Suite 201, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Ruiz-Margain', 'Affiliation': 'Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'W Ray', 'Initials': 'WR', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Duarte-Rojo', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Thomas E. Starzl Transplantation Institute, University of Pittsburgh Medical Center, 3471 Fifth Avenue, Suite 201, Pittsburgh, PA, 15213, USA. duarterojoa@upmc.edu.'}]",Digestive diseases and sciences,['10.1007/s10620-019-06034-2']
667,31547752,"Agitation, Oxidative Stress, and Cytokines in Alzheimer Disease: Biomarker Analyses From a Clinical Trial With Nabilone for Agitation.","The endocannabinoid system has been a target of interest for agitation in Alzheimer disease (AD) because of potential behavioral effects and its potential impact on mechanisms implicated in AD such as oxidative stress (OS) and neuroinflammation. We explored whether serum markers of OS and neuroinflammation were associated with response to the cannabinoid nabilone in agitated patients with AD (N = 38). All participants were enrolled in a 14-week, double-blind, cross-over trial comparing nabilone to placebo (6 weeks each) with a 1-week washout between phases. Samples were collected at the start and end of each phase. The cross-sectional relationship agitation (Cohen Mansfield Agitation Inventory) and OS and inflammatory markers were investigated to select markers of interest. Significant markers were then explored for their relationship with response. The OS marker, 4-hydroxynonenal (4-HNE;  F 1, 35  = 6.41,  P  = .016), and the proinflammatory cytokine, tumor necrosis factor-α (TNF-α;  F 1, 29  = 3.97,  P  = .06), were associated with agitation severity, and TNF-α remained significantly associated ( F 2, 25  = 3.69,  P  = .04) after adjustment for cognition. In the placebo phase, lower baseline 4-HNE was associated with decreases in agitation severity only (b = 0.01,  P  = .01), while lower baseline TNF-α was associated with decreases in agitation severity in the nabilone phase only (b = 1.14,  P  = .045). Changes in 4-HNE were not associated with changes in agitation severity in either phase. In the nabilone phase, lower baseline TNF-α was associated with decreases in agitation severity (b = 1.14,  P  = .045), and decreases in TNF-α were associated with decreases in agitation severity (b = 1.12,  P  = .006). These findings suggest that OS and neuroinflammation may be associated with agitation severity, while nabilone may have anti-inflammatory effects.",2020,"In the placebo phase, lower baseline 4-HNE was associated with decreases in agitation severity only (b = 0.01,  P  = .01), while lower baseline TNF-α was associated with decreases in agitation severity in the nabilone phase only (b = 1.14,  P  = .045).","['Alzheimer Disease', 'agitated patients with AD (N = 38']",['placebo'],"['TNF-α', 'agitation severity', 'Agitation, Oxidative Stress, and Cytokines', 'agitation severity, and TNF-α', 'serum markers of OS and neuroinflammation', 'proinflammatory cytokine, tumor necrosis factor-α']","[{'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0162491', 'cui_str': 'Serum Markers'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}]",,0.190073,"In the placebo phase, lower baseline 4-HNE was associated with decreases in agitation severity only (b = 0.01,  P  = .01), while lower baseline TNF-α was associated with decreases in agitation severity in the nabilone phase only (b = 1.14,  P  = .045).","[{'ForeName': 'Myuri', 'Initials': 'M', 'LastName': 'Ruthirakuhan', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Herrmann', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Andreazza', 'Affiliation': 'Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Nicolaas Paul L G', 'Initials': 'NPLG', 'LastName': 'Verhoeff', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Gallagher', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Black', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Krista L', 'Initials': 'KL', 'LastName': 'Lanctôt', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}]",Journal of geriatric psychiatry and neurology,['10.1177/0891988719874118']
668,32417564,Sham Surgery Studies in Orthopaedic Surgery May Just Be a Sham: A Systematic Review of Randomized Placebo-Controlled Trials.,"PURPOSE


To determine the limitations of randomized sham surgery-controlled trials in orthopaedic sports medicine and fidelity of the trials' conclusions.
METHODS


Randomized placebo surgery-controlled trials in orthopaedic sports medicine were included in this Preferred Reporting Items for Systematic Reviews and Meta-Analyses-guided systematic review. Several aspects of investigation design and conduct were analyzed: genetic analysis for propensity to placebo response, equipoise of informed consent process, geography of trial subjects, percentage of eligible subjects willing to be randomized, changes from protocol publication to results publication, and perioperative complications.
RESULTS


Seven sham surgery-controlled trials (845 subjects [370 knees, 449 shoulders, 26 elbows]; 5 from Europe, 1 from North America, and 1 from Australia; all superiority model, efficacy design) were analyzed. There were consistent methodologic deficiencies across studies. No studies reported genetic analysis of susceptibility to placebo response. Three studies (43%) were underpowered. Crossover rates ranged from 8% to 36%, which led to un-blinding in up to 100% of subjects. There were low enrollment rates of eligible subjects (up to 57% refused randomization). Follow-up was short term (2 years or less in all but one study). Complication rates ranged from 0% to 12.5%, with complications occurring in both groups (no significant difference between groups in any study).
CONCLUSIONS


Randomized sham-controlled studies in orthopaedic sports medicine have significant methodologic deficiencies that may invalidate their conclusions. Randomized trial design (with or without placebo control) may be optimized through the inclusion of per-protocol analysis, blinding index, equivalence or noninferiority trial design, and a nontreatment group.
LEVEL OF EVIDENCE


Level II Systematic Review of Level II studies.",2020,"Complication rates ranged from 0% to 12.5% with complications occurring in both groups (no significant difference between groups in any study).
","['orthopedic sports medicine', 'Seven sham surgery-controlled trials (845 subjects [370 knees, 449 shoulders, 26 elbows]; five Europe, one North America, one Australia', 'Orthopedic Surgery']","['Placebo', 'placebo']",['Complication rates'],"[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038040', 'cui_str': 'Medicine, Sport'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}]",845.0,0.715691,"Complication rates ranged from 0% to 12.5% with complications occurring in both groups (no significant difference between groups in any study).
","[{'ForeName': 'Kyle R', 'Initials': 'KR', 'LastName': 'Sochacki', 'Affiliation': 'Houston Methodist Orthopedic and Sports Medicine, Houston, Texas, U.S.A.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Mather', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University School of Medicine, Durham, North Carolina, U.S.A.'}, {'ForeName': 'Benedict U', 'Initials': 'BU', 'LastName': 'Nwachukwu', 'Affiliation': 'Hospital for Special Surgery, New York, New York, U.S.A.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dong', 'Affiliation': 'Houston Methodist Orthopedic and Sports Medicine, Houston, Texas, U.S.A.'}, {'ForeName': 'Shane J', 'Initials': 'SJ', 'LastName': 'Nho', 'Affiliation': 'Section of Young Adult Hip Surgery, Division of Sports Medicine, Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Cote', 'Affiliation': 'UConn Musculoskeletal Institute at UConn Health, Farmington, Connecticut, U.S.A.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Harris', 'Affiliation': 'Houston Methodist Orthopedic and Sports Medicine, Houston, Texas, U.S.A.. Electronic address: joshuaharrismd@gmail.com.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.05.001']
669,32415575,"Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis: 52-Week Results from a Phase 3, Head-to-Head Study (IXORA-S).","INTRODUCTION


Patients with plaque psoriasis often have nail psoriasis, which is difficult to treat. Ixekizumab (IXE) and ustekinumab (UST) are biologics with established efficacy in nail psoriasis. We present post hoc data from a head-to-head trial of IXE and UST (IXORA-S) to examine the efficacy in nail psoriasis in patients with moderate-to-severe plaque psoriasis over 52 weeks.
METHODS


In IXORA-S,  randomised patients received IXE (N = 136) or UST (N = 166) per label for 52 weeks. Eighty-four (61.8%) and 105 (63.3%) of the patients treated with IXE or UST, respectively, had baseline fingernail psoriasis (Nail Psoriasis Severity Index [NAPSI] > 0); of these, 54 (64.3%) and 63 (60.0%) patients, respectively, had significant baseline fingernail psoriasis (defined as NAPSI ≥ 16 with ≥ 4 fingernails involved). The proportion of patients achieving NAPSI = 0, a NAPSI score change from baseline and correlations in Psoriasis Area of Severity Index (PASI) and NAPSI improvement over 52 weeks were examined.
RESULTS


Progressive improvement occurred in both treatment groups over 52 weeks. Statistically significantly more patients achieved NAPSI = 0 with IXE versus UST by week 16-20, and the proportions continued to increase through week 52 among patients with baseline nail psoriasis (61.9 vs. 28.6%, respectively; P < 0.001), including those with significant nail psoriasis (57.4 vs. 17.5%, respectively; P < 0.001). Similar results were observed for NAPSI score improvement from baseline to week 52. Interestingly, the presence of nail psoriasis was associated with lower skin response with UST but not with IXE.
CONCLUSIONS


Ixekizumab was superior to UST in the clearance of nail psoriasis, with earlier improvement continued through 52 weeks regardless of baseline nail severity.
TRIAL REGISTRATION


ClinicalTrials.gov identifier; NCT02561806.",2020,Ixekizumab (IXE) and ustekinumab (UST) are biologics with established efficacy in nail psoriasis.,"['patients with moderate-to-severe plaque psoriasis over 52\xa0weeks', 'Patients with plaque psoriasis often have nail psoriasis', 'nail psoriasis', 'Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis']","['IXE and UST (IXORA-S', 'IXE or UST', 'IXE', 'Ixekizumab', 'Ixekizumab (IXE) and ustekinumab (UST', 'UST']","['Psoriasis Area of Severity Index (PASI) and NAPSI improvement', 'nail psoriasis', 'NAPSI score improvement', 'baseline fingernail psoriasis (Nail Psoriasis Severity Index [NAPSI', 'Progressive improvement', 'skin response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0406322', 'cui_str': 'Psoriasis of nail'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0406322', 'cui_str': 'Psoriasis of nail'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0222001', 'cui_str': 'Fingernails'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0312646', 'cui_str': 'Finding related to response to skin test'}]",,0.0802576,Ixekizumab (IXE) and ustekinumab (UST) are biologics with established efficacy in nail psoriasis.,"[{'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wasel', 'Affiliation': 'Stratica Medical and Probity Medical Research, Edmonton, AB, Canada. nwasel@straticamedical.com.'}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Research Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Lars E', 'Initials': 'LE', 'LastName': 'French', 'Affiliation': 'Department of Dermatology and Allergy, University Hospital, Ludwig Maximilian University of Munich (LMU Munich), Munich, Germany.'}, {'ForeName': 'Curdin', 'Initials': 'C', 'LastName': 'Conrad', 'Affiliation': 'Department of Dermatology, Lausanne University Hospital (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dutronc', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Lovisa', 'Initials': 'L', 'LastName': 'Berggren', 'Affiliation': 'HaaPACS GmbH, Schriesheim, Germany.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': ""Department of Dermatology, University Hospital of Nice-Côte d'Azur, Nice, France.""}]",Dermatology and therapy,['10.1007/s13555-020-00383-x']
670,31519680,Investigating the impact of enhanced community case management and monthly screening and treatment on the transmissibility of malaria infections in Burkina Faso: study protocol for a cluster-randomised trial.,"INTRODUCTION


A large proportion of malaria-infected individuals in endemic areas do not experience symptoms that prompt treatment-seeking. These asymptomatically infected individuals may retain their infections for many months during which sexual-stage parasites (gametocytes) are produced that may be transmissible to mosquitoes. Reductions in malaria transmission could be achieved by detecting and treating these infections early. This study assesses the impact of enhanced community case management (CCM) and monthly screening and treatment (MSAT) on the prevalence and transmissibility of malaria infections.
METHODS AND ANALYSIS


This cluster-randomised trial will take place in Sapone, an area of intense, highly seasonal malaria in Burkina Faso. In total, 180 compounds will be randomised to one of three interventions: arm 1 - current standard of care with passively monitored malaria infections; arm 2 - standard of care plus enhanced CCM, comprising active weekly screening for fever, and detection and treatment of infections in fever positive individuals using conventional rapid diagnostic tests (RDTs); or arm 3 - standard of care and enhanced CCM, plus MSAT using RDTs. The study will be conducted over approximately 18 months covering two high-transmission seasons and the intervening dry season. The recruitment strategy aims to ensure that overall transmission and force of infection is not affected so we are able to continuously evaluate the impact of interventions in the context of ongoing intense malaria transmission. The main objectives of the study are to determine the impact of enhanced CCM and MSAT on the prevalence and density of parasitaemia and gametocytaemia and the transmissibility of infections. This will be achieved by molecular detection of infections in all study participants during start and end season cross-sectional surveys and routine sampling of malaria-positive individuals to assess their infectiousness to mosquitoes.
ETHICS AND DISSEMINATION


The study has been reviewed and approved by the London School of Hygiene and Tropical Medicine (LSHTM) (Review number: 14724) and The Centre National de Recherche et de Formation sur le Paludisme institutional review board (IRB) (Deliberation N° 2018/000002/MS/SG/CNRFP/CIB) and Burkina Faso national medical ethics committees (Deliberation N° 2018-01-010).Findings of the study will be shared with the community via local opinion leaders and community meetings. Results may also be shared through conferences, seminars, reports, theses and peer-reviewed publications; disease occurrence data and study outcomes will be shared with the Ministry of Health. Data will be published in an online digital repository.
TRIAL REGISTRATION NUMBER


NCT03705624.",2019,"This study assesses the impact of enhanced community case management (CCM) and monthly screening and treatment (MSAT) on the prevalence and transmissibility of malaria infections.
",[],"['enhanced community case management (CCM) and monthly screening and treatment (MSAT', 'conventional rapid diagnostic tests (RDTs); or arm 3 - standard of care and enhanced CCM, plus MSAT using RDTs', 'enhanced community case management and monthly screening and treatment']",['prevalence and density of parasitaemia and gametocytaemia and the transmissibility of infections'],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0086143'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",180.0,0.134834,"This study assesses the impact of enhanced community case management (CCM) and monthly screening and treatment (MSAT) on the prevalence and transmissibility of malaria infections.
","[{'ForeName': 'Katharine A', 'Initials': 'KA', 'LastName': 'Collins', 'Affiliation': 'Department or Medical Microbiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Alphonse', 'Initials': 'A', 'LastName': 'Ouedraogo', 'Affiliation': 'Department of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Wamdaogo Moussa', 'Initials': 'WM', 'LastName': 'Guelbeogo', 'Affiliation': 'Department of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Shehu S', 'Initials': 'SS', 'LastName': 'Awandu', 'Affiliation': 'Department or Medical Microbiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Stone', 'Affiliation': 'Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Issiaka', 'Initials': 'I', 'LastName': 'Soulama', 'Affiliation': 'Department of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Maurice S', 'Initials': 'MS', 'LastName': 'Ouattara', 'Affiliation': 'Department of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Apollinaire', 'Initials': 'A', 'LastName': 'Nombre', 'Affiliation': 'Department of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Amidou', 'Initials': 'A', 'LastName': 'Diarra', 'Affiliation': 'Department of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bradley', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Prashanth', 'Initials': 'P', 'LastName': 'Selvaraj', 'Affiliation': 'Institute for Disease Modeling, Bellevue, Washington, USA.'}, {'ForeName': 'Jaline', 'Initials': 'J', 'LastName': 'Gerardin', 'Affiliation': 'Institute for Disease Modeling, Bellevue, Washington, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Drakeley', 'Affiliation': 'Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'Bousema', 'Affiliation': 'Department or Medical Microbiology, Radboudumc, Nijmegen, The Netherlands teun.bousema@radboudumc.nl.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Tiono', 'Affiliation': 'Department of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.'}]",BMJ open,['10.1136/bmjopen-2019-030598']
671,31556447,Benefit-Finding Intervention Delivered Individually to Alzheimer Family Caregivers: Longer-Term Outcomes of a Randomized Double-Blind Controlled Trial.,"OBJECTIVES


To examine the longer-term effects of benefit-finding on caregivers' depressive symptoms (primary outcome), and global burden, role overload, psychological well-being, and positive aspects of caregiving (secondary outcomes).
METHOD


Ninety-six Hong Kong Chinese caregivers of relatives with Alzheimer's disease were randomly assigned to receive the benefit-finding intervention (BFT) or one of the two control conditions, namely, simplified psychoeducation (lectures only; SIM-PE) or standard psychoeducation (STD-PE). Caregivers received four biweekly one-to-one interventions of 3 hours each at their own homes. We focused on outcomes measured at 4- and 10-month follow-ups. The trajectories of intervention effects were modeled by BFT × time and BFT × time2 interaction terms.
RESULTS


Mixed-effects regression showed significant BFT × time2 interaction effects on depressive symptoms against both control conditions, suggesting diminishing BFT effects over time. Z tests showed that, compared with controls, BFT participants reported substantial reductions in depressive symptoms at 4-month follow-up (d = -0.85 and -0.75 vs. SIM-PE and STD-PE, respectively). For depressive symptoms measured at 10-month follow-up, BFT was indistinguishable from STD-PE, whereas a moderate effect was observed in comparison with SIM-PE (d = -0.52). Moreover, positive aspects of caregiving, but not other secondary outcomes, continued to show intervention effect up to 10-month follow-up.
DISCUSSION


Benefit-finding is an efficacious intervention for depressive symptoms in Alzheimer caregivers, with strong effects in the medium-term post-intervention and possible moderate effects in the longer-term post-intervention.",2020,"For depressive symptoms measured at 10-month follow-up, BFT was indistinguishable from STD-PE whereas a moderate effect was observed in the comparison with SIM-PE (d=-0.52).","[""96 Hong Kong Chinese caregivers of relatives with Alzheimer's disease"", 'Alzheimer Family Caregivers']","['benefit-finding intervention (BFT) or one of two control conditions, namely, simplified psychoeducation (lectures only; SIM-PE) or standard psychoeducation (STD-PE']","['BFT effects', ""caregivers' depressive symptoms (primary outcome), and global burden, role overload, psychological well-being, and positive aspects of caregiving (secondary outcomes"", 'depressive symptoms']","[{'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",,0.474899,"For depressive symptoms measured at 10-month follow-up, BFT was indistinguishable from STD-PE whereas a moderate effect was observed in the comparison with SIM-PE (d=-0.52).","[{'ForeName': 'Sheung-Tak', 'Initials': 'ST', 'LastName': 'Cheng', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong, Hong Kong.'}, {'ForeName': 'Emily P M', 'Initials': 'EPM', 'LastName': 'Mak', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong, Hong Kong.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Kwok', 'Affiliation': 'Department of Medicine and Therapeutics, Hong Kong.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Fung', 'Affiliation': 'Department of Psychology, Hong Kong.'}, {'ForeName': 'Linda C W', 'Initials': 'LCW', 'LastName': 'Lam', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbz118']
672,32109221,Side Effects of Intravenous Patient-Controlled Analgesia with Remifentanil Compared with Intermittent Epidural Bolus for Labour Analgesia - A Randomized Controlled Trial.,"INTRODUCTION


Epidural analgesia is considered a gold standard in obstetric anaesthesia and analgesia. However, in situation when it is contraindicated, unwanted by the patient or simply unavailable, remifentanil can be an excellent alternative. The goal of our study is to analyse the side effects of intravenous patient-controlled analgesia (IV PCA) with remifentanil compared with epidural analgesia during delivery.
MATERIAL AND METHODS


This study included 155 pregnant women in term for birth, divided into 2 groups: a remifentanil group (RG), and an epidural group (EG). Patients in the RG received intravenous PCA with remifentanil, while patients in the ЕG received epidural analgesia with programmed intermittent bolus dosing. Our primary outcome was maternal safety; the secondary outcome was neonatal safety.
RESULTS


The results present a significantly lower SaO2 value of the parturients in the RG (96.95 ± 1.4 vs 98.22 ± 0.6), and a significantly higher respiratory rate per minute in the EG at all time points after the onset of analgesia (20.85 ± 1.4 vs 18.67 ± 0.9). There was more frequent sedation, nausea and vomiting in the RG, while in the EG there was a more elevated temperature, itching and irregularities in the CTG record. Regarding the newborn, there was no significant difference between the two groups in the Apgar scores, pH, pCO2, pO2, and bicarbonate, while there was a significantly lower value of the base excess in the RG group.
CONCLUSION


PCA with remifentanil is safe for the mother, foetus and the newborn, with minimal side effects. Continuous respiratory monitoring, oxygen supply and following of all consensus recommendations are mandatory.",2019,"Regarding the newborn, there was no significant difference between the two groups in the Apgar scores, pH, pCO2, pO2, and bicarbonate, while there was a significantly lower value of the base excess in the RG group.
","['155 pregnant women in term for birth, divided into 2 groups: a']","['remifentanil group (RG', 'intravenous patient-controlled analgesia (IV PCA', 'remifentanil', 'PCA with remifentanil', 'Intravenous Patient-Controlled Analgesia with Remifentanil']","['SaO2 value', 'frequent sedation, nausea and vomiting', 'elevated temperature, itching and irregularities', 'Apgar scores, pH, pCO2, pO2, and bicarbonate', 'maternal safety; the secondary outcome was neonatal safety']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0030625', 'cui_str': 'PCA'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0391839', 'cui_str': 'PCO2'}, {'cui': 'C1283004', 'cui_str': 'PO>2< measurement (procedure)'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}]",155.0,0.0593108,"Regarding the newborn, there was no significant difference between the two groups in the Apgar scores, pH, pCO2, pO2, and bicarbonate, while there was a significantly lower value of the base excess in the RG group.
","[{'ForeName': 'Dafina', 'Initials': 'D', 'LastName': 'Karadjova', 'Affiliation': 'University Clinic for Gynaecology and Obstetrics, Skopje, North Macedonia.'}, {'ForeName': 'Mirjana', 'Initials': 'M', 'LastName': 'Shosholcheva', 'Affiliation': 'University Clinic for surgical diseases ""St. Naum Ohridski"", Skopje, North Macedonia.'}, {'ForeName': 'Еmilija', 'Initials': 'Е', 'LastName': 'Ivanov', 'Affiliation': 'University Clinic for Gynaecology and Obstetrics, Skopje, North Macedonia.'}, {'ForeName': 'Аtanas', 'Initials': 'А', 'LastName': 'Sivevski', 'Affiliation': 'University Clinic for Gynaecology and Obstetrics, Skopje, North Macedonia.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Kjaev', 'Affiliation': 'University Clinic for Gynaecology and Obstetrics, Skopje, North Macedonia.'}, {'ForeName': 'Adrijan', 'Initials': 'A', 'LastName': 'Kartalov', 'Affiliation': 'University Clinic for TOARILUC, Skopje, North Macedonia.'}, {'ForeName': 'Biljana', 'Initials': 'B', 'LastName': 'Kuzmanovska', 'Affiliation': 'University Clinic for TOARILUC, Skopje, North Macedonia.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Spasova', 'Affiliation': 'University Clinic for Gynaecology and Obstetrics, Skopje, North Macedonia.'}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Kocovski', 'Affiliation': 'University Clinic for Gynaecology and Obstetrics, Skopje, North Macedonia.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Aleksiovska-Papestiev', 'Affiliation': 'University Clinic for Gynaecology and Obstetrics, Skopje, North Macedonia.'}]",Prilozi (Makedonska akademija na naukite i umetnostite. Oddelenie za medicinski nauki),['10.2478/prilozi-2020-0009']
673,31482853,Family Separation and the Impact of Digital Technology on the Mental Health of Refugee Families in the United States: Qualitative Study.,"BACKGROUND


Conflicts around the world have resulted in a record high number of refugees. Family separation is a critical factor that impacts refugee mental health. Thus, it is important to explore refugees' ability to maintain contact with family members across the globe and the ways in which they attempt to do so. It is increasingly common for refugees to use information and communication technologies (ICTs), which include mobile phones, the internet, and social media sites, such as Facebook, WhatsApp, Skype, and Viber, for these purposes.
OBJECTIVE


The aim of this study was to explore refugees' perceptions of the impact of communication through ICTs on their mental health, the exercise of agency by refugees within the context of ICT use, especially their communication with their families, and logistical issues that affect their access to ICTs in the United States.
METHODS


We used a constructivist grounded theory approach to analyze in-depth interviews of 290 adult refugee participants from different countries, who were enrolled in a randomized controlled trial of a community-based mental health intervention.
RESULTS


Analyses showed that communication through ICTs had differing impacts on the mental health of refugee participants. ICTs, as channels of communication between separated families, were a major source of emotional and mental well-being for a large number of refugee participants. However, for some participants, the communication process with separated family members through digital technology was mentally and emotionally difficult. The participants also discussed ways in which they hide adversities from their families through selective use of different ICTs. Several participants noted logistical and financial barriers to communicating with their families through ICTs.
CONCLUSIONS


These findings are important in elucidating aspects of refugee agency and environmental constraints that need to be further explicated in theories related to ICT use as well as in providing insight for researchers and practitioners involved in efforts related to migration and mental health.",2019,"ICTs, as channels of communication between separated families, were a major source of emotional and mental well-being for a large number of refugee participants.",['290 adult refugee participants from different countries'],"['Digital Technology', 'community-based mental health intervention']",['mental health'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",290.0,0.0560477,"ICTs, as channels of communication between separated families, were a major source of emotional and mental well-being for a large number of refugee participants.","[{'ForeName': 'Sayyed Fawad Ali', 'Initials': 'SFA', 'LastName': 'Shah', 'Affiliation': 'Department of Communication, Jacksonville State University, Jacksonville, AL, United States.'}, {'ForeName': 'Julia Meredith', 'Initials': 'JM', 'LastName': 'Hess', 'Affiliation': 'Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, NM, United States.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Goodkind', 'Affiliation': 'Department of Sociology, University of New Mexico, Albuquerque, NM, United States.'}]",Journal of medical Internet research,['10.2196/14171']
674,31377056,Effect of bardoxolone methyl on the urine albumin-to-creatinine ratio in patients with type 2 diabetes and stage 4 chronic kidney disease.,"Bardoxolone methyl attenuates inflammation by inducing nuclear factor erythroid-derived 2-related factor 2 and suppressing nuclear factor κB. The Bardoxolone Methyl Evaluation in Patients With Chronic Kidney Disease and Type 2 Diabetes (BEACON) trial was a phase 3 placebo-controlled, randomized, double-blind, parallel-group, international, multicenter trial in 2185 patients with type 2 diabetes mellitus and stage 4 chronic kidney disease. BEACON was terminated because of safety concerns, largely related to a significant increase in early heart failure events in patients randomized to bardoxolone methyl. Bardoxolone methyl resulted in increased estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio. Herein, we present post hoc analyses characterizing the relation between the urine albumin-to-creatinine ratio and eGFR. The urine albumin-to-creatinine ratio and eGFR were assessed every four weeks through Week 12, followed by assessments every eight weeks thereafter, and 4 weeks after the last dose of bardoxolone methyl was administered. The initial increases in urine albumin-to-creatinine ratio observed in patients randomized to bardoxolone methyl were attenuated after six months. Multivariable regression analysis identified baseline eGFR and eGFR over time as the dominant factors associated with change in the urine albumin-to-creatinine ratio. Relative to placebo, bardoxolone methyl resulted in a significant decrease in albuminuria when indexed to eGFR (least-squared means: -0.035 [95% confidence interval -0.031 to -0.039]). Thus, among patients with type 2 diabetes mellitus and stage 4 chronic kidney disease treated with bardoxolone methyl, changes in albuminuria are directly related to changes in eGFR, challenging the conventional construct that increases in albuminuria universally reflect kidney injury and denote harm.",2019,Bardoxolone methyl resulted in increased estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio.,"['Patients With Chronic Kidney Disease and Type 2 Diabetes', '2185 patients with type 2 diabetes mellitus and stage 4 chronic kidney disease (CKD', 'patients with type 2 diabetes and stage 4 chronic kidney disease', 'patients with type 2 diabetes mellitus and stage 4 CKD treated with']","['bardoxolone methyl', 'placebo', 'placebo, bardoxolone methyl', 'Bardoxolone methyl']","['urine albumin-to-creatinine ratio', 'albuminuria when indexed to eGFR', 'early heart failure events', 'urine albumin-to-creatinine ratio and eGFR', 'glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1100924', 'cui_str': 'methyl 2-cyano-3,12-dioxoolean-1,9-dien-28-oate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042037'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}]",2185.0,0.0880907,Bardoxolone methyl resulted in increased estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio.,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, University of Copenhagen, Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'Department of Product Development, Reata Pharmaceuticals, Irving, Texas, USA.'}, {'ForeName': 'Melanie P', 'Initials': 'MP', 'LastName': 'Chin', 'Affiliation': 'Department of Product Development, Reata Pharmaceuticals, Irving, Texas, USA.'}, {'ForeName': 'Angie', 'Initials': 'A', 'LastName': 'Goldsberry', 'Affiliation': 'Department of Product Development, Reata Pharmaceuticals, Irving, Texas, USA.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'McCullough', 'Affiliation': 'Baylor Scott & White Heart and Vascular Hospital, Dallas, Texas, USA.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Meyer', 'Affiliation': 'Department of Product Development, Reata Pharmaceuticals, Irving, Texas, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Packham', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Pergola', 'Affiliation': 'Renal Associates PA, San Antonio, Texas; USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Spinowitz', 'Affiliation': 'Department of Medicine, New York Presbyterian Queens, Flushing, New York, USA.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Sprague', 'Affiliation': 'Department of Medicine, Northshore Medical University Health System-University of Chicago, Evanston, Illinois, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Warnock', 'Affiliation': 'Division of Nephrology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Division of Nephrology, Stanford University School of Medicine, Palo Alto, California, USA. Electronic address: gchertow@stanford.edu.'}]",Kidney international,['10.1016/j.kint.2019.04.027']
675,30244671,Inflammation and micronutrient biomarkers predict clinical HIV treatment failure and incident active TB in HIV-infected adults: a case-control study.,"BACKGROUND


Various individual biomarkers of inflammation and micronutrient status, often correlated with each other, are associated with adverse treatment outcomes in human immunodeficiency virus (HIV)-infected adults. The objective of this study was to conduct exploratory factor analysis (EFA) on multiple inflammation and micronutrient biomarkers to identify biomarker groupings (factors) and determine their association with HIV clinical treatment failure (CTF) and incident active tuberculosis (TB).
METHODS


Within a multicountry randomized trial of antiretroviral therapy (ART) efficacy (PEARLS) among HIV-infected adults, we nested a case-control study (n = 290; 124 cases, 166 controls) to identify underlying factors, based on EFA of 23 baseline (pre-ART) biomarkers of inflammation and micronutrient status. The EFA biomarker groupings results were used in Cox proportional hazards models to study the association with CTF (primary analysis where cases were incident World Health Organization stage 3, 4 or death by 96 weeks of ART) or incident active TB (secondary analysis).
RESULTS


In the primary analysis, based on eigenvalues> 1 in the EFA, three factors were extracted: (1) carotenoids), (2) other nutrients, and (3) inflammation. In multivariable-adjusted models, there was an increased hazard of CTF (adjusted hazard ratio (aHR) 1.47, 95% confidence interval (CI)1.17-1.84) per unit increase of inflammation factor score. In the secondary incident active TB case-control analysis, higher scores of the high carotenoids and low interleukin-18 factor was protective against incident active TB (aHR 0.48, 95% CI 0.26-0.87).
CONCLUSION


Factors identified through EFA were associated with adverse outcomes in HIV-infected individuals. Strategies focused on reducing adverse HIV outcomes through therapeutic interventions that target the underlying factor (e.g., inflammation) rather than focusing on an individual observed biomarker might be more effective and warrant further investigation.",2018,"In multivariable-adjusted models, there was an increased hazard of CTF (adjusted hazard ratio (aHR) 1.47, 95% confidence interval (CI)1.17-1.84) per unit increase of inflammation factor score.","['HIV-infected adults', 'HIV-infected adults, we nested a case-control study (n\u2009=\u2009290; 124 cases, 166 controls) to identify underlying factors, based on EFA of 23 baseline (pre-ART) biomarkers of inflammation and micronutrient status', 'human immunodeficiency virus (HIV)-infected adults']",['antiretroviral therapy (ART) efficacy (PEARLS'],"['hazard of CTF', 'adverse HIV outcomes', 'inflammation factor score']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007328', 'cui_str': 'Case-Referrent Studies'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.258761,"In multivariable-adjusted models, there was an increased hazard of CTF (adjusted hazard ratio (aHR) 1.47, 95% confidence interval (CI)1.17-1.84) per unit increase of inflammation factor score.","[{'ForeName': 'Rupak', 'Initials': 'R', 'LastName': 'Shivakoti', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. rs3895@cumc.columbia.edu.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Gupte', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Tripathy', 'Affiliation': 'National AIDS Research Institute, Pune, India.'}, {'ForeName': 'Selvamuthu', 'Initials': 'S', 'LastName': 'Poongulali', 'Affiliation': 'YR Gaitonde Center for AIDS Research and Education, Chennai, India.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Kanyama', 'Affiliation': 'UNC Lilongwe, Lilongwe, Malawi.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Berendes', 'Affiliation': 'Malawi College of Medicine-Johns Hopkins University Research Project, Blantyre, Malawi.'}, {'ForeName': 'Sandra W', 'Initials': 'SW', 'LastName': 'Cardoso', 'Affiliation': 'STD/AIDS Clinical Research Laboratory, Instituto de Pesquisa Clinica Evandro Chagas, Fundacao Oswaldo Cruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'Breno R', 'Initials': 'BR', 'LastName': 'Santos', 'Affiliation': 'Hospital Nossa Senhora de Conceiçã, Porto Alegre, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'La Rosa', 'Affiliation': 'Asociacion Civil Impacta Salud y Educacion, Lima, Peru.'}, {'ForeName': 'Noluthando', 'Initials': 'N', 'LastName': 'Mwelase', 'Affiliation': 'Department of Medicine, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Pillay', 'Affiliation': 'Durban International Clinical Research Site, Durban University of Technology, Durban, South Africa.'}, {'ForeName': 'Wadzanai', 'Initials': 'W', 'LastName': 'Samaneka', 'Affiliation': 'University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Riviere', 'Affiliation': 'Les Centres GHESKIO, Port-Au-Prince, Haiti.'}, {'ForeName': 'Patcharaphan', 'Initials': 'P', 'LastName': 'Sugandhavesa', 'Affiliation': 'Research Institute for Health Sciences, Chiang Mai, Thailand.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Bollinger', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Balagopal', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Semba', 'Affiliation': 'Department of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Christian', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC medicine,['10.1186/s12916-018-1150-3']
676,26333743,A Validated Orthopaedic Surgical Simulation Model for Training and Evaluation of Basic Arthroscopic Skills.,"BACKGROUND


To our knowledge, there is currently no validated educational model to evaluate and teach basic arthroscopic skills that is widely accessible to orthopaedic residency training programs. The primary objective was to design and to validate a surgical simulation model by demonstrating that subjects with increasing level of training perform better on basic arthroscopic simulation tasks. The secondary objective was to evaluate inter-rater and intra-rater reliability of the model.
METHODS


Prospectively recruited participants were divided by level of training into four groups. Subjects performed six basic arthroscopic tasks using a box model: (1) probing, (2) grasping, (3) tissue resection, (4) shaving, (5) tissue liberation and suture-passing, and (6) knot-tying. A score was calculated according to time required to complete each task and deductions for technical errors. A priori total global score, of a possible 100 points, was calculated by averaging scores from all six tasks using equal weights.
RESULTS


A total of forty-nine participants were recruited for this study. Participants were grouped by level of training: Group 1 (novice: fifteen medical students and interns), Group 2 (junior residents: twelve postgraduate year-2 or postgraduate year-3 residents), Group 3 (senior residents: sixteen postgraduate year-4 or postgraduate year-5 residents), and Group 4 (six arthroscopic surgeons). The mean total global score (and standard deviation) differed significantly between groups (p < 0.001): 29.0 ± 13.6 points for Group 1, 40.3 ± 12.1 points for Group 2, 57.6 ± 7.4 points for Group 3, and 72.4 ± 3.0 points for Group 4. Pairwise comparison with Tukey correction confirmed construct validity by showing significant improvement in overall performance by increasing level of training between all groups (p < 0.05). The model proved to be highly reliable with an intraclass correlation coefficient of 0.99 for both inter-rater and intra-rater reliability.
CONCLUSIONS


A simulation model was successfully designed to teach and evaluate basic arthroscopic skills showing good construct validity. This arthroscopic simulation model is inexpensive, valid, and reliable and has the potential to be implemented in other training programs.",2015,Pairwise comparison with Tukey correction confirmed construct validity by showing significant improvement in overall performance by increasing level of training between all groups (p < 0.05).,"['A total of forty-nine participants were recruited for this study', 'Participants were grouped by level of training: Group 1 (novice: fifteen medical students and interns), Group 2 (junior residents: twelve postgraduate year-2 or postgraduate year-3 residents), Group 3 (senior residents: sixteen postgraduate year-4 or postgraduate year-5 residents), and Group 4 (six arthroscopic surgeons', 'Prospectively recruited participants were divided by level of training into four groups']","['six basic arthroscopic tasks using a box model: (1) probing, (2) grasping, (3) tissue resection, (4) shaving, (5) tissue liberation and suture-passing, and (6) knot-tying']","['mean total global score (and standard deviation', 'overall performance', 'inter-rater and intra-rater reliability of the model']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0441876', 'cui_str': 'Group 4 (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",49.0,0.0252214,Pairwise comparison with Tukey correction confirmed construct validity by showing significant improvement in overall performance by increasing level of training between all groups (p < 0.05).,"[{'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Coughlin', 'Affiliation': 'Division of Orthopaedic Surgery, Montreal General Hospital, McGill University Health Centre, 1650 Cedar Avenue Room B5 159.6, Montreal, Quebec H3G 1A4, Canada. E-mail address for R.P. Coughlin: ryan.coughlin@mail.mcgill.ca. E-mail address for T. Pauyo: thierry.pauyo@mail.mcgill.ca. E-mail address for J.C. Sutton: joseph.sutton@mail.mcgill.ca.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Pauyo', 'Affiliation': 'Division of Orthopaedic Surgery, Montreal General Hospital, McGill University Health Centre, 1650 Cedar Avenue Room B5 159.6, Montreal, Quebec H3G 1A4, Canada. E-mail address for R.P. Coughlin: ryan.coughlin@mail.mcgill.ca. E-mail address for T. Pauyo: thierry.pauyo@mail.mcgill.ca. E-mail address for J.C. Sutton: joseph.sutton@mail.mcgill.ca.'}, {'ForeName': 'J Carl', 'Initials': 'JC', 'LastName': 'Sutton', 'Affiliation': 'Division of Orthopaedic Surgery, Montreal General Hospital, McGill University Health Centre, 1650 Cedar Avenue Room B5 159.6, Montreal, Quebec H3G 1A4, Canada. E-mail address for R.P. Coughlin: ryan.coughlin@mail.mcgill.ca. E-mail address for T. Pauyo: thierry.pauyo@mail.mcgill.ca. E-mail address for J.C. Sutton: joseph.sutton@mail.mcgill.ca.'}, {'ForeName': 'Larry P', 'Initials': 'LP', 'LastName': 'Coughlin', 'Affiliation': ""Division of Orthopaedic Surgery, St. Mary's Hospital Center, 3830 Avenue Lacombe, Montréal, Quebec H3T 1M7, Canada. E-mail address: lpcoughlin@hotmail.ca.""}, {'ForeName': 'Stephane G', 'Initials': 'SG', 'LastName': 'Bergeron', 'Affiliation': 'Department of Orthopaedic Surgery, Jewish General Hospital, 3755 Côte-Sainte-Catherine Road, Pavilion E, Room E-003, Montreal, Quebec H3T 1E2, Canada. E-mail address: stephane.bergeron@mail.harvard.edu.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.N.01140']
677,32417629,"Melatonin supplementation and the effects on clinical and metabolic status in Parkinson's disease: A randomized, double-blind, placebo-controlled trial.","OBJECTIVE


This study was performed to evaluate the impact of melatonin supplementation on clinical and metabolic profiles in people with Parkinson's disease (PD).
METHODS


This randomized, double-blind, placebo-controlled clinical trial was conducted among 60 patients with PD. Participants were randomly divided into two groups to intake either 10 mg melatonin (two melatonin capsules, 5 mg each) (n = 30) or placebo (n = 30) once a day, 1 h before bedtime for 12 weeks.
RESULTS


Melatonin supplementation significantly reduced the Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β -2.33; 95% CI, -3.57, -1.09; P < 0.001), Pittsburgh Sleep Quality Index (PSQI) (β -1.82; 95% CI, -3.36, -0.27; P = 0.02), Beck Depression Inventory (BDI) (β -3.32; 95% CI, -5.23, -1.41; P = 0.001) and Beck Anxiety Inventory (BAI) (β -2.22; 95% CI, -3.84, -0.60; P = 0.008) compared with the placebo treatment. Compared with the placebo, melatonin supplementation resulted in a significant reduction in serum high sensitivity C-reactive protein (hs-CRP) (β -0.94 mg/L; 95% CI, -1.55, -0.32; P = 0.003) and a significant elevation in plasma total antioxidant capacity (TAC) (β 108.09 mmol/L; 95% CI, 78.21, 137.97; P < 0.001) and total glutathione (GSH) levels (β 77.08 μmol/L; 95% CI, 44.29, 109.86; P < 0.001). Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β -13.16 mg/dL; 95% CI, -25.14, -1.17; P = 0.03) and LDL- (β -10.44 mg/dL; 95% CI, -20.55, -0.34; P = 0.04) compared with the placebo.
CONCLUSIONS


Overall, melatonin supplementation for 12 weeks to patients with PD had favorable effects on the UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR, but did not affect other metabolic profiles.",2020,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[""Parkinson's disease"", ""people with Parkinson's disease (PD"", '60 patients with PD']","['melatonin supplementation', 'Melatonin supplementation', 'placebo, melatonin supplementation', 'melatonin (two melatonin capsules', 'placebo']","['Pittsburgh Sleep Quality Index (PSQI', 'homeostasis model of assessment-insulin resistance (HOMA-IR', 'UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR', 'serum high sensitivity C-reactive protein (hs-CRP', 'plasma total antioxidant capacity (TAC', 'total glutathione (GSH) levels', 'LDL', 'Beck Anxiety Inventory (BAI) ', 'Beck Depression Inventory (BDI', 'serum insulin levels', ""Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β""]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0034821', 'cui_str': 'LDL receptor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}]",60.0,0.782673,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Daneshvar Kakhaki', 'Affiliation': 'Autoimmune Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Vahidreza', 'Initials': 'V', 'LastName': 'Ostadmohammadi', 'Affiliation': 'Infectious Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran; Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Kouchaki', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran; Department of Neurology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavod', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Omid Reza', 'Initials': 'OR', 'LastName': 'Tamtaji', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Russel', 'Initials': 'R', 'LastName': 'J Reiter', 'Affiliation': 'Department of Cellular and Structural Biology, University of Texas Health Science, Center, San Antonio, TX, USA.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mansournia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: asemi_z@Kaums.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105878']
678,31566030,An assessment of urine THC immunoassay in healthy volunteers receiving an oral proton-pump inhibitor.,"Introduction:  Limitations of urine drug-screening (UDS) by immunoassay include false-positive results. Pantoprazole, a proton-pump inhibitor (PPI), is reported to cause false-positive results for THC on UDS. The objective of this study was to determine if oral PPIs cause false-positive THC results using the THC One Step Marijuana Test Strip ® . Methods:  Eligible healthy volunteers completed a 5-day course of a PPI followed by urine testing using the THC One Step Marijuana Test Strip ® . Phase one included 3 subjects taking pantoprazole 40 mg once daily for 5 days. On day 5, urine specimens underwent THC screening. Phase two included 9 subjects randomized to 5-day supply of once-daily oral esomeprazole 20 mg, lansoprazole 15 mg, or omeprazole 20 mg. All study methods and testing mirrored those in phase one. Results:  All 12 subjects completed the study protocol. All urine samples collected on day 5 were negative for THC in all subjects. Discussion:  Our results demonstrate that oral PPIs did not cause a false-positive THC using the THC One Step Marijuana Test Strip ® . Limitations include small sample size, use of a single commercial immunoassay, and inability to confirm medication compliance. Further, large-scale research using other commercial urine immunoassays is warranted.",2020,Our results demonstrate that oral PPIs did not cause a false-positive THC using the THC One Step Marijuana Test Strip ® .,"['Eligible healthy volunteers completed a 5-day course of a PPI followed by urine testing using the THC One Step Marijuana Test Strip ® ', 'healthy volunteers receiving an oral proton-pump inhibitor', 'All 12 subjects completed the study protocol']","['pantoprazole', '5-day supply of once-daily oral esomeprazole 20\u2009mg, lansoprazole 15\u2009mg, or omeprazole', 'Pantoprazole, a proton-pump inhibitor (PPI', 'urine drug-screening (UDS']",['urine THC immunoassay'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0042037'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C1553116', 'cui_str': 'Test strip technique'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1146111', 'cui_str': 'Esomeprazole 20 MG'}, {'cui': 'C1145804', 'cui_str': 'lansoprazole 15 MG'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}]","[{'cui': 'C0042037'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0020980', 'cui_str': 'Immunoassay'}]",9.0,0.0394035,Our results demonstrate that oral PPIs did not cause a false-positive THC using the THC One Step Marijuana Test Strip ® .,"[{'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Vohra', 'Affiliation': 'Upstate New York Poison Center, SUNY Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Jeanna M', 'Initials': 'JM', 'LastName': 'Marraffa', 'Affiliation': 'Upstate New York Poison Center, SUNY Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Wojcik', 'Affiliation': 'Department of Emergency Medicine, SUNY Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Eggleston', 'Affiliation': 'Department of Emergency Medicine, SUNY Upstate Medical University, Syracuse, NY, USA.'}]","Clinical toxicology (Philadelphia, Pa.)",['10.1080/15563650.2019.1662917']
679,31551385,"SToP (See, Treat, Prevent) skin sores and scabies trial: study protocol for a cluster randomised, stepped-wedge trial for skin disease control in remote Western Australia.","INTRODUCTION


Skin is important in Australian Aboriginal culture informing kinship and identity. In many remote Aboriginal communities, scabies and impetigo are very common. Untreated skin infections are painful, itchy and frequently go untreated due to under-recognition and lack of awareness of their potential serious complications. We hypothesise that the skin infection burden in remote Aboriginal communities can be reduced by implementing streamlined training and treatment pathways integrated with environmental health and health promotion activities, tested in the See, Treat, Prevent (SToP skin sores and scabies) trial.
METHODS AND ANALYSIS


SToP will evaluate a skin control programme using a stepped-wedge, cluster randomised trial design with three intervention components (the 'SToP activities'): (1) seeing skin infections (development of training resources implemented within a community dermatology model); (2) treating skin infections (employing the latest evidence for impetigo, and scabies treatment); and (3) preventing skin infections (embedded, culturally informed health promotion and environmental health activities). Four community clusters in the remote Kimberley region of Western Australia will participate. Following baseline data collection, two clusters will be randomly allocated to the SToP activities. At 12 months, the remaining two clusters will transition to the SToP activities. The primary outcome is the diagnosis of impetigo in children (5-9 years) at school-based surveillance. Secondary outcome measures include scabies diagnosis, other child health indicators, resistance to cotrimoxazole in circulating pathogenic bacteria, determining the economic burden of skin disease and evaluating the cost effectiveness of SToP activities.
ETHICS AND DISSEMINATION


This study protocol was approved by the health ethics review committees at the Child and Adolescent Health Service (Approval number RGS0000000584), the Western Australian Aboriginal Health Ethics Committee (Reference number: 819) and the University of Western Australia (Reference RA/4/20/4123). Study findings will be shared with community members, academic and medical communities via publications and presentations, and in reports to funders. Authorship for all publications based on this study will be determined in line with the Uniform Requirements for Manuscripts Submitted to Biomedical Journals published by the International Committee of Medical Journal Editors. Sharing results with organisations and communities who contributed to the study is paramount. The results of the SToP trial will be shared with participants in a suitable format, such as a single summary page provided to participants or presentations to communities, the Kimberly Aboriginal Health Planning Forum Research Subcommittee and other stakeholders as appropriate and as requested. Communication and dissemination will require ongoing consultation with Aboriginal communities to determine appropriate formats.
TRIAL REGISTRATION NUMBER


ACTRN12618000520235.",2019,The primary outcome is the diagnosis of impetigo in children (5-9 years) at school-based surveillance.,['skin disease control in remote Western Australia'],"[""three intervention components (the 'SToP activities'): (1) seeing skin infections (development of training resources implemented within a community dermatology model); (2) treating skin infections (employing the latest evidence for impetigo, and scabies treatment); and (3) preventing skin infections (embedded, culturally informed health promotion and environmental health activities""]","['diagnosis of impetigo in children (5-9 years) at school-based surveillance', 'scabies diagnosis, other child health indicators, resistance to cotrimoxazole in circulating pathogenic bacteria, determining the economic burden of skin disease and evaluating the cost effectiveness of SToP activities']","[{'cui': 'C0037274', 'cui_str': 'Dermatoses'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0037278', 'cui_str': 'Skin Diseases, Infectious'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0021099', 'cui_str': 'Impetigo'}, {'cui': 'C0036262', 'cui_str': 'Scabies'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0014413', 'cui_str': 'Environmental Health Science'}]","[{'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0021099', 'cui_str': 'Impetigo'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0037274', 'cui_str': 'Dermatoses'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",819.0,0.0727153,The primary outcome is the diagnosis of impetigo in children (5-9 years) at school-based surveillance.,"[{'ForeName': 'Marianne J', 'Initials': 'MJ', 'LastName': 'Mullane', 'Affiliation': 'Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Barnett', 'Affiliation': 'Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Cannon', 'Affiliation': 'Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Carapetis', 'Affiliation': 'Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Christophers', 'Affiliation': 'Nirrumbuk Environmental Health & Services, Nirrumbuk Aboriginal Corporation, Broome, Western Australia, Australia.'}, {'ForeName': 'Juli', 'Initials': 'J', 'LastName': 'Coffin', 'Affiliation': 'Aboriginal Health, Telethon Kids Kimberley, Telethon Kids Institute, University of Western Australia, Broome, Western Australia, Australia.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Jones', 'Affiliation': 'Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Marsh', 'Affiliation': 'Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Frieda', 'Initials': 'F', 'LastName': 'Mc Loughlin', 'Affiliation': 'Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': ""O'Donnell"", 'Affiliation': 'Kimberley Aboriginal Medical Services, Broome, Western Australia, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Pavlos', 'Affiliation': 'Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Bec', 'Initials': 'B', 'LastName': 'Smith', 'Affiliation': 'Western Australian Country Health Services-Kimberley, Broome, Western Australia, Australia.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Steer', 'Affiliation': 'Tropical Diseases Research Group, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Steven Y C', 'Initials': 'SYC', 'LastName': 'Tong', 'Affiliation': 'Peter Doherty Institute for Infection and Immunity, Royal Melbourne Hospital and The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Roz', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Asha C', 'Initials': 'AC', 'LastName': 'Bowen', 'Affiliation': 'Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Nedlands, Western Australia, Australia asha.bowen@telethonkids.org.au.'}]",BMJ open,['10.1136/bmjopen-2019-030635']
680,31552526,Omalizumab versus intranasal steroids in the post-operative management of patients with allergic fungal rhinosinusitis.,"PURPOSE


Allergic fungal rhinosinusitis (AFRS) is a common disorder with a high prevalence and a very high incidence of recurrence. Management includes surgery and medical treatment in the form of local and/or systemic steroids. However, some cases are resistant to the action of steroids and further treatment is warranted. Being an immune-mediated disorder, targeting IgE seems a logical step. Immunotherapy drugs acting on the IgE (e.g. omalizumab) can modify the clinical course of the disease. This study aimed at evaluating the effect of omalizumab on the clinical course of patients undergoing surgery for AFRS.
MATERIALS AND METHODS


This is a two-arm prospective, randomized, single blind clinical trial among patients with AFRS. Twenty patients were included and randomly divided into two groups: Group A; 10 patients received a single subcutaneous injection of omalizumab (Xolair ' Novartis) (150 mg) 2 weeks postoperatively. Group B: 10 patients received local steroids nasal sprays (budesonide or mometasone furoate, 100 μg twice daily for 6 months, starting 2 weeks postoperatively. All patients underwent history, examination, CT scan and IgE level estimation and were submitted to endoscopic sinus surgery. They were evaluated at 4 weeks interval for 6 months.
RESULTS


In both groups there were highly significant differences between pre/post-operative SNOT-20 scores, TNSS scores, total IgE level and Philpott-Javer staging scores. Comparison between the two study groups at 24 weeks showed a highly significant difference (p = 0.001) between post-operative SNOT 20 and TNSS scores in favour of group A. There was no statistically significant difference between the two study groups as regarding postoperative total IgE or Philpott-Javer scores. There were two recurrences in both arms, but no significant side effects.
DISCUSSION


We compared a single post operative injection of omalizumab with twice daily intranasal steroid spray for 6 months. Both treatments were effective, but the omalizumab group showed a more significant clinical and endoscopic response. There were no significant side effects in both arms. This novel approach used a single low dose injection of omalizumab increased the compliance of the patients with minimal complications. Longer follow-up of the patients is ongoing to determine the optimal time for re-injection. The only downside was the higher cost of omalizumab compared to that of local steroids.",2020,There was no statistically significant difference between the two study groups as regarding postoperative total IgE or Philpott-Javer scores.,"['patients undergoing surgery for AFRS', 'patients with allergic fungal rhinosinusitis', '10 patients received', 'patients with AFRS', 'Allergic fungal rhinosinusitis (AFRS', 'Twenty patients', 'patients with minimal complications']","['endoscopic sinus surgery', 'omalizumab', 'Omalizumab versus intranasal steroids', ""single subcutaneous injection of omalizumab (Xolair ' Novartis"", 'omalizumab with twice daily intranasal steroid spray', 'local steroids nasal sprays (budesonide or mometasone furoate']","['side effects', 'TNSS scores', 'clinical and endoscopic response', 'pre/post-operative SNOT-20 scores, TNSS scores, total IgE level and Philpott-Javer staging scores', 'postoperative total IgE or Philpott-Javer scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0948780', 'cui_str': 'Rhinosinusitis'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C1174773', 'cui_str': 'Xolair'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0066700', 'cui_str': 'mometasone furoate'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",,0.0231268,There was no statistically significant difference between the two study groups as regarding postoperative total IgE or Philpott-Javer scores.,"[{'ForeName': 'Badr Eldin', 'Initials': 'BE', 'LastName': 'Mostafa', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Ain-Shams University, 75 El Nozha Street, Heliopolis-Cairo, 11351, Egypt. bemostafa@med.asu.edu.eg.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fadel', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Ain-Shams University, 75 El Nozha Street, Heliopolis-Cairo, 11351, Egypt.'}, {'ForeName': 'Mohammed Amir', 'Initials': 'MA', 'LastName': 'Mohammed', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Ain-Shams University, 75 El Nozha Street, Heliopolis-Cairo, 11351, Egypt.'}, {'ForeName': 'Tarek Abdel Hamid', 'Initials': 'TAH', 'LastName': 'Hamdi', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Ain-Shams University, 75 El Nozha Street, Heliopolis-Cairo, 11351, Egypt.'}, {'ForeName': 'Anas Mohammed', 'Initials': 'AM', 'LastName': 'Askoura', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Ain-Shams University, 75 El Nozha Street, Heliopolis-Cairo, 11351, Egypt.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-019-05650-y']
681,32418809,Effect of transspinal direct current stimulation on afferent pain signalling in humans.,"Anodal transspinal Direct Current Stimulation (tsDCS) has been suggested as a means to treat neuropathic pain by reducing pain signalling/processing and Laser Evoked Potentials (LEPs) likewise as a method to evaluate such reduction. However, results in previous studies are disagreeing. To evaluate these claims using rigorous methodology, LEPs were evoked from hands and feet in healthy volunteers. The N2 potential and three psychophysic parameters (general- and pinprick pain, warmth) were used to evaluate the signalling and appreciation of pain respectively. This was made at three time points; at baseline, directly- and 30 min after low thoracic tsDCS (20 min, 2.5 mA, cathode on shoulder). The study was randomized, cross over, double blinded and placebo controlled. At the group level, low thoracic anodal tsDCS produced reduced perceptions of all three tested pain qualities from the foot (p < 0.05 - p < 0.001). These reductions began during stimulation and became more pronounced during the 30 min after its cessation (p < 0.05 - p < 0.01). The LEP parameter alteration mirroring these changes was latency prolongation (p < 0.05 - p < 0.001) whereas amplitude reductions were in par with placebo stimulation. Similar but less pronounced and only transient (during stimulation, p < 0.05 - p < 0.001) changes, were seen for hand stimulation. The interindividual variation was large. The findings indicate that anodal tsDCS may become a technique to treat neuropathic pain by reducing pain signalling/processing and LEPs likewise a method to evaluate such reduction.",2020,"At the group level, low thoracic anodal tsDCS produced reduced perceptions of all three tested pain qualities from the foot (","['healthy volunteers', 'humans']","['placebo', 'anodal tsDCS', 'Anodal transspinal Direct Current Stimulation (tsDCS', 'transspinal direct current stimulation']","['pain qualities', 'latency prolongation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}]",,0.0976847,"At the group level, low thoracic anodal tsDCS produced reduced perceptions of all three tested pain qualities from the foot (","[{'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Thordstein', 'Affiliation': 'Department of Clinical Neurophysiology and Department of Biomedical and Clinical Science, Linköping University, Linköping, Sweden. Electronic address: magnus.thordstein@liu.se.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Svantesson', 'Affiliation': 'Department of Clinical Neurophysiology and Department of Biomedical and Clinical Science, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Hedayat', 'Initials': 'H', 'LastName': 'Rahin', 'Affiliation': 'Department of Clinical Neurophysiology and Department of Biomedical and Clinical Science, Linköping University, Linköping, Sweden.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.04.116']
682,32417119,Impact of a Capacity-Building Intervention on Food Marketing Features in Recreation Facilities.,"OBJECTIVE


To explore the impact of a capacity-building intervention (CBI) to support implementing provincial nutrition guidelines on food marketing in recreation facilities (RFs).
DESIGN


Randomized controlled trial within a natural experiment: food marketing in RFs from 3 guideline provinces randomly assigned to intervention (GL+CBI) or comparison (GL-ONLY) was compared with facilities in 1 province without guidelines (NO-GL). Food marketing was assessed by the Food and Beverage Marketing Assessment Tool for Settings.
SETTING


Canadian provinces with/without voluntary nutrition guidelines for RFs.
PARTICIPANTS


51 RFs.
INTERVENTION


18-month CBI.
MAIN OUTCOME MEASURES


Change in Food and Beverage Marketing Assessment Tool for Settings scores and marketing features between baseline and follow-up across groups.
ANALYSIS


Kruskal-Wallis with post hoc Mann-Whitney U tests.
RESULTS


No significant differences in food marketing features between baseline and follow-up across groups except for a change in food marketing frequency (P = 0.045). The increase in frequency in NO-GL (median, 6.0; interquartile range, -2.0 to 8.5) was significantly greater than changes in the GL+CBI (P = 0.033) and GL-ONLY sites (P = 0.049).
CONCLUSIONS AND IMPLICATIONS


Capacity-building was not associated with improved food marketing features potentially because of nonmandated nutrition guidelines, low priority for change, and vague or narrow facility goals and guidelines. Nutrition guidelines with specific unhealthy food marketing restrictions should be mandated and supported.",2020,No significant differences in food marketing features between baseline and follow-up across groups except for a change in food marketing frequency (P = .045).,"['51 RFs', 'recreation facilities (RFs', 'Recreation Facilities', 'Canadian provinces with/without voluntary nutrition guidelines for RFs']","['intervention (GL+CBI) or comparison (GL-ONLY', 'capacity-building intervention (CBI', 'Capacity-Building Intervention']","['food marketing features', 'frequency in NO-GL', 'food marketing frequency', 'Change in Food and Beverage Marketing Assessment Tool for Settings scores and marketing features']","[{'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C3658297', 'cui_str': 'Dietary Guidelines'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2718026', 'cui_str': 'Capacity Building'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0024826', 'cui_str': 'Marketing'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0524819', 'cui_str': 'Foods and drinks'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",51.0,0.0773804,No significant differences in food marketing features between baseline and follow-up across groups except for a change in food marketing frequency (P = .045).,"[{'ForeName': 'Rachel J L', 'Initials': 'RJL', 'LastName': 'Prowse', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada. Electronic address: prowse@ualberta.ca.'}, {'ForeName': 'Patti-Jean', 'Initials': 'PJ', 'LastName': 'Naylor', 'Affiliation': 'School of Exercise Science, Physical and Health Education, University of Victoria, Victoria, British Columbia, Canada.'}, {'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'Olstad', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Storey', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Carson', 'Affiliation': 'Faculty of Physical Education and Recreation, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Louise C', 'Initials': 'LC', 'LastName': 'Mâsse', 'Affiliation': ""BC Children's Hospital Research Institute, School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Sara F L', 'Initials': 'SFL', 'LastName': 'Kirk', 'Affiliation': 'Healthy Populations Institute, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Raine', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2020.03.009']
683,32063109,"Protective effect of N-acetylcysteine on oxaliplatin-induced neurotoxicity in patients with colorectal and gastric cancers: A randomized, double blind, placebo-controlled, clinical trial.","PURPOSE


Neuropathy is one of the most prevalent and dose-limiting side effects of platinum chemotherapeutic agents. N-acetylcysteine is an antioxidant thiol which is able to increase whole blood concentration of glutathione, which may be protective against chemotherapy-induced neuropathy. The aim of this study was to evaluate the effect of N-acetylcysteine on neurotoxicity induced by oxaliplatin in patients with gastric or colorectal cancers.
METHODS


During this randomized, double-blinded, placebo-controlled clinical trial, the preventive effect of N-acetylcysteine effervescent tablets was assessed in comparison with placebo, on neuropathy occurrence. Thirty-two patients with colorectal or gastric cancer randomly received N-acetylcysteine (two 600 mg tablets) or placebo tablets 1 h before receiving oxaliplatin in dose in XELOX (oxaliplatin and capecitabine regimen) for eight courses of chemotherapy. Neuropathy severity was assessed after eight courses of chemotherapy based on National Cancer Institute Common Terminology for Adverse Events (NCI-CTCAE) criteria neuropathy grading scale and also sensory and motor electrophysiological assessment was performed by a neurologist.
RESULTS


The NCI-CTCAE scale grade of patients in intervention group was significantly lower than placebo group after eight course of oxaliplatin ( P  = 0.01); however, the sensory electrophysiological assessment result was not significantly different ( P  = 0.501). No patient in both group had motor electrophysiological changes.
CONCLUSION


The results of this study showed that N-acetylcysteine could reduce the incidence of the neuropathy induced by oxaliplatin and delay its occurrence in patients with gastric or colorectal cancers.",2020,,['patients with colorectal and gastric cancers'],"['oxaliplatin-induced neurotoxicity', 'placebo', 'N-acetylcysteine']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]",[],,0.479953,,"[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Bondad', 'Affiliation': 'Department of Internal Medicine, Mashhad University of Medical sciences, Mashhad, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Boostani', 'Affiliation': 'Department of Neurology, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Barri', 'Affiliation': 'Department of Hematology and Medical Oncology, Imam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Elyasi', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Abolghasem', 'Initials': 'A', 'LastName': 'Allahyari', 'Affiliation': 'Department of Hematology and Medical Oncology, Imam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners,['10.1177/1078155219900788']
684,27703145,Biobank attributes associated with higher patient participation: a randomized study.,"The objectives of the study were to assess patients' intent to participate in a hospital-based biobank and to explore the factors associated with higher participation. A 23-item questionnaire was developed to survey a random sample of patients in a Swiss university hospital. Two vignettes describing hypothetical biobanks were incorporated in the survey and patients were asked whether they would agree to participate. Three factors were randomly manipulated in each vignette using a factorial design: cancer-oriented research vs general consent, one vs several reviews of the patient's chart, and genetic vs blood protein analyses (first vignette); blood sample vs oral swabbing, local vs international project, and a follow-up visit vs no visit (second vignette). Of the 1140 respondents, 73.6 and 69.6%, respectively, agreed to participate in the biobank. Biospecimen collection via oral swabbing, single chart review, and no follow-up were associated with higher participation. Participation was also higher among younger patients, Europeans, patients who had a positive opinion on research, and blood/organ donors. Biobanking was supported by a majority of patients, especially if biospecimens were collected through non-invasive techniques or if data collection was done once. The scope of consent, the scale of the project, or the tests performed on biospecimens did not influence participation.",2016,"Of the 1140 respondents, 73.6 and 69.6%, respectively, agreed to participate in the biobank.","['patients in a Swiss university hospital', 'younger patients, Europeans, patients who had a positive opinion on research, and blood/organ donors']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0241315', 'cui_str': 'Swiss (ethnic group)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0871010', 'cui_str': 'Opinions'}, {'cui': 'C0035168'}, {'cui': 'C0005768'}, {'cui': 'C0029206', 'cui_str': 'Organ donor (person)'}]",[],[],,0.0276934,"Of the 1140 respondents, 73.6 and 69.6%, respectively, agreed to participate in the biobank.","[{'ForeName': 'Angèle', 'Initials': 'A', 'LastName': 'Gayet-Ageron', 'Affiliation': 'Division of Clinical Epidemiology, Department of Health and Community Medicine, University of Geneva Hospitals and Faculty of Medicine, 6 Rue Gabrielle Perret-Gentil, Geneva 14, Switzerland. angele.gayet-ageron@hcuge.ch.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Rudaz', 'Affiliation': 'Division of Clinical Epidemiology, Department of Health and Community Medicine, University of Geneva Hospitals and Faculty of Medicine, 6 Rue Gabrielle Perret-Gentil, Geneva 14, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Perneger', 'Affiliation': 'Division of Clinical Epidemiology, Department of Health and Community Medicine, University of Geneva Hospitals and Faculty of Medicine, 6 Rue Gabrielle Perret-Gentil, Geneva 14, Switzerland.'}]",European journal of human genetics : EJHG,['10.1038/ejhg.2016.132']
685,31563272,"Antidepressant Efficacy of Prolonged Intermittent Theta Burst Stimulation Monotherapy for Recurrent Depression and Comparison of Methods for Coil Positioning: A Randomized, Double-Blind, Sham-Controlled Study.","BACKGROUND


Prolonged intermittent theta burst stimulation (piTBS) with triple doses of the standard protocol is an updated form of repetitive transcranial magnetic stimulation, and it is an effective add-on intervention for major depressive disorder. In the present study, our objective was to investigate the antidepressant efficacy of piTBS monotherapy. Efficacy between the standard 5-cm method and magnetic resonance imaging (MRI)-guided coil positioning to the left dorsolateral prefrontal cortex method was also compared.
METHODS


In the present double-blind, randomized, sham-controlled trial, 105 patients with recurrent depression who exhibited no responses to at least one adequate antidepressant treatment for the prevailing episode were assigned randomly to one of three groups: piTBS monotherapy (n = 35), repetitive transcranial magnetic stimulation monotherapy (n = 35), or sham stimulation (n = 35). The acute treatment period was 2 weeks. Half of the patients were randomized to MRI navigation in each group.
RESULTS


No serious adverse events were observed. The piTBS group exhibited significantly greater decreases in depression scores than the sham group at week 2 (-40.0% vs. -13.9%; p < .001 after correcting for multiple comparisons by Bonferroni [effect size (Cohen's d) = 1.12]), and the odds ratio for responses was high. The MRI navigation method (-32.4%) did not yield better antidepressant effects than the standard method (-40.6%). Brain stimulation and 17-item Hamilton Depression Rating Scale changes in the first week were the most important variables for predicting antidepressant responses.
CONCLUSIONS


Left prefrontal piTBS monotherapy is effective for the treatment of recurrent depression, and the MRI-guided method of coil targeting is not better than the standard method.",2020,"The piTBS group exhibited significantly greater decreases in depression scores than the sham group at week 2 (-40.0% vs. -13.9%; p < .001 after correcting for multiple comparisons by Bonferroni [effect size (Cohen's d) = 1.12]), and the odds ratio for responses was high.",['105 patients with recurrent depression who exhibited no responses to at least one adequate antidepressant treatment for the prevailing episode'],"['MRI navigation', 'magnetic resonance imaging (MRI)-guided coil positioning', 'repetitive transcranial magnetic stimulation monotherapy (n\xa0= 35), or sham stimulation', 'piTBS monotherapy', 'Prolonged Intermittent Theta Burst Stimulation Monotherapy', 'Prolonged intermittent theta burst stimulation (piTBS']","['Efficacy', 'Antidepressant Efficacy', 'Brain stimulation and 17-item Hamilton Depression Rating Scale changes', 'depression scores', 'serious adverse events']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression (disorder)'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3152857', 'cui_str': 'Prevail'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",105.0,0.171371,"The piTBS group exhibited significantly greater decreases in depression scores than the sham group at week 2 (-40.0% vs. -13.9%; p < .001 after correcting for multiple comparisons by Bonferroni [effect size (Cohen's d) = 1.12]), and the odds ratio for responses was high.","[{'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry and Institute of Brain Science, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Brain Research Center, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Institute of Cognitive Neuroscience, National Central University, Jhongli, Taiwan. Electronic address: ctil2@vghtpe.gov.tw.'}, {'ForeName': 'Chih-Ming', 'Initials': 'CM', 'LastName': 'Cheng', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry and Institute of Brain Science, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry and Institute of Brain Science, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chi-Hung', 'Initials': 'CH', 'LastName': 'Juan', 'Affiliation': 'Institute of Cognitive Neuroscience, National Central University, Jhongli, Taiwan.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry and Institute of Brain Science, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry and Institute of Brain Science, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Jia-Shyun', 'Initials': 'JS', 'LastName': 'Jeng', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry and Institute of Brain Science, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry and Institute of Brain Science, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry and Institute of Brain Science, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry and Institute of Brain Science, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Brain Research Center, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Cheng Hsin General Hospital, Taipei, Taiwan.'}]",Biological psychiatry,['10.1016/j.biopsych.2019.07.031']
686,26563148,"Effects of a mindfulness-based intervention on mindful eating, sweets consumption, and fasting glucose levels in obese adults: data from the SHINE randomized controlled trial.","We evaluated changes in mindful eating as a potential mechanism underlying the effects of a mindfulness-based intervention for weight loss on eating of sweet foods and fasting glucose levels. We randomized 194 obese individuals (M age = 47.0 ± 12.7 years; BMI = 35.5 ± 3.6; 78% women) to a 5.5-month diet-exercise program with or without mindfulness training. The mindfulness group, relative to the active control group, evidenced increases in mindful eating and maintenance of fasting glucose from baseline to 12-month assessment. Increases in mindful eating were associated with decreased eating of sweets and fasting glucose levels among mindfulness group participants, but this association was not statistically significant among active control group participants. Twelve-month increases in mindful eating partially mediated the effect of intervention arm on changes in fasting glucose levels from baseline to 12-month assessment. Increases in mindful eating may contribute to the effects of mindfulness-based weight loss interventions on eating of sweets and fasting glucose levels.",2016,"Increases in mindful eating were associated with decreased eating of sweets and fasting glucose levels among mindfulness group participants, but this association was not statistically significant among active control group participants.","['194 obese individuals (M age = 47.0 ± 12.7 years; BMI = 35.5 ± 3.6; 78% women', 'obese adults']","['diet-exercise program with or without mindfulness training', 'mindfulness-based intervention']","['mindful eating and maintenance of fasting glucose', 'mindful eating, sweets consumption, and fasting glucose levels', 'weight loss on eating of sweet foods and fasting glucose levels', 'eating of sweets and fasting glucose levels', 'fasting glucose levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517546', 'cui_str': '12.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0453865', 'cui_str': 'Sweet food (substance)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",194.0,0.0148886,"Increases in mindful eating were associated with decreased eating of sweets and fasting glucose levels among mindfulness group participants, but this association was not statistically significant among active control group participants.","[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Mason', 'Affiliation': 'Osher Center for Integrative Medicine, University of California - San Francisco (UCSF), 1545 Divisadero Street, 4th Floor, San Francisco, CA, 94115, USA. ashley.mason@ucsf.edu.'}, {'ForeName': 'Elissa S', 'Initials': 'ES', 'LastName': 'Epel', 'Affiliation': 'Osher Center for Integrative Medicine, University of California - San Francisco (UCSF), 1545 Divisadero Street, 4th Floor, San Francisco, CA, 94115, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Kristeller', 'Affiliation': 'Department of Psychology, Indiana State University, Terre Haute, IN, USA.'}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Moran', 'Affiliation': 'Osher Center for Integrative Medicine, University of California - San Francisco (UCSF), 1545 Divisadero Street, 4th Floor, San Francisco, CA, 94115, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dallman', 'Affiliation': 'Center for Health and Community, UCSF, San Francisco, CA, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Lustig', 'Affiliation': 'Department of Pediatrics, UCSF, San Francisco, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Acree', 'Affiliation': 'Osher Center for Integrative Medicine, University of California - San Francisco (UCSF), 1545 Divisadero Street, 4th Floor, San Francisco, CA, 94115, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bacchetti', 'Affiliation': 'Department of Epidemiology and Biostatistics, UCSF, San Francisco, CA, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Laraia', 'Affiliation': 'UC Berkeley School of Public Health, Berkeley, CA, USA.'}, {'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Hecht', 'Affiliation': 'Osher Center for Integrative Medicine, University of California - San Francisco (UCSF), 1545 Divisadero Street, 4th Floor, San Francisco, CA, 94115, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Daubenmier', 'Affiliation': 'Osher Center for Integrative Medicine, University of California - San Francisco (UCSF), 1545 Divisadero Street, 4th Floor, San Francisco, CA, 94115, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-015-9692-8']
687,26484407,"INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1 PREDICTS INSULIN SENSITIVITY AND INSULIN AREA-UNDER-THE-CURVE IN OBESE, NONDIABETIC ADOLESCENTS.","OBJECTIVE


To compare fasting insulin-like growth factor binding protein 1 (IGFBP-1) to other fasting indices as a surrogate marker of insulin sensitivity and resistance calculated from a 3-hour oral glucose tolerance test (oGTT).
METHODS


Fasting IGFBP-1 and oGTT were performed at 0 (n = 77), 52 (n = 54), and 100 (n = 38) weeks in a study investigating metformin treatment of obesity in adolescents. Insulin area-under-the-curve (IAUC) and the composite insulin sensitivity index (CISI) calculated from the oGTT were compared to fasting IGFBP-1, homeostasis model assessment-insulin resistance, and corrected insulin release at the glucose peak (CIRgp).
RESULTS


IGFBP-1 and the ratio of IGFBP-1 to fasting insulin were significantly correlated with indices based on timed sampling, including IAUC, CISI, and CIRgp. In addition, a significant effect of IGFBP-1, but not IGFBP-1 to insulin at time zero, was observed for IAUC and CISI.
CONCLUSION


Our results indicate that fasting IGFBP-1 may be a useful marker of insulin sensitivity and secretion.",2016,"RESULTS


IGFBP-1 and the ratio of IGFBP-1 to fasting insulin were significantly correlated with indices based on timed sampling, including IAUC, CISI, and CIRgp.",['treatment of obesity in adolescents'],"['IGFBP-1', 'INSULIN-LIKE GROWTH FACTOR', 'metformin']","['Insulin area-under-the-curve (IAUC) and the composite insulin sensitivity index (CISI', 'ratio of IGFBP-1 to fasting insulin']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0123256', 'cui_str': 'IGFBP-1'}, {'cui': 'C1328726', 'cui_str': 'Insulin-like growth factor'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0123256', 'cui_str': 'IGFBP-1'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]",,0.0215136,"RESULTS


IGFBP-1 and the ratio of IGFBP-1 to fasting insulin were significantly correlated with indices based on timed sampling, including IAUC, CISI, and CIRgp.","[{'ForeName': 'Phillip D K', 'Initials': 'PD', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Lustig', 'Affiliation': ''}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Lenders', 'Affiliation': ''}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Baillargeon', 'Affiliation': ''}, {'ForeName': 'Darrell M', 'Initials': 'DM', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP15885.OR']
688,31041883,Optimal designs for group randomized trials and group administered treatments with outcomes at the subject and group level.,"With group randomized trials complete groups of subject are randomized to treatment conditions. Such grouping also occurs in individually randomized trials where treatment is administered in groups. Outcomes may be measured at the level of the subject, but also at the level of the group. The optimal design determines the number of groups and the number of subjects per group in the intervention and control conditions. It is found by taking a budgetary constraint into account, where costs are associated with implementing the intervention and control, and with taking measurements on subject and groups. The optimal design is found such that the effect of treatment is estimated with highest efficiency, and the total costs do not exceed the budget that is available. The design that is optimal for the outcome at the subject level is not necessarily optimal for the outcome at the group level. Multiple-objective optimal designs consider both outcomes simultaneously. Their aim is to find a design that has high efficiencies for both outcome measures. An Internet application for finding the multiple-objective optimal design is demonstrated on the basis of an example from smoking prevention in primary education, and another example on consultation time in primary care.",2020,The design that is optimal for the outcome at the subject level is not necessarily optimal for the outcome at the group level.,[],[],[],[],[],[],,0.0287129,The design that is optimal for the outcome at the subject level is not necessarily optimal for the outcome at the group level.,"[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Moerbeek', 'Affiliation': 'Department of Methodology and Statistics, Utrecht University, Utrecht, the Netherlands.'}]",Statistical methods in medical research,['10.1177/0962280219846149']
689,26151090,"A Randomized, Placebo-controlled Trial of Roflumilast. Effect on Proline-Glycine-Proline and Neutrophilic Inflammation in Chronic Obstructive Pulmonary Disease.","RATIONALE


Roflumilast is a therapeutic agent in the treatment of chronic obstructive pulmonary disease (COPD). It has antiinflammatory effects; however, it is not known whether it can affect a biologic pathway implicated in COPD pathogenesis and progression. The self-propagating acetyl-proline-glycine-proline (AcPGP) pathway is a novel means of neutrophilic inflammation that is pathologic in the development of COPD. AcPGP is produced by extracellular matrix collagen breakdown with prolyl endopeptidase and leukotriene A4 hydrolase serving as the enzymes responsible for its production and degradation, respectively.
OBJECTIVES


We hypothesized that roflumilast would decrease AcPGP, halting the feed-forward cycle of inflammation.
METHODS


We conducted a single-center, placebo-controlled, randomized study investigating 12 weeks of roflumilast treatment added to current therapy in moderate-to-severe COPD with chronic bronchitis. Subjects underwent sputum and blood analyses, pulmonary function testing, exercise tolerance, and quality-of-life assessment at 0, 4, and 12 weeks.
MEASUREMENTS AND MAIN RESULTS


Twenty-seven patients were enrolled in the intention-to-treat analysis. Roflumilast treatment decreased sputum AcPGP by more than 50% (P < 0.01) and prolyl endopeptidase by 46% (P = 0.02), without significant improvement in leukotriene A4 hydrolase activity compared with placebo. Roflumilast also reduces other inflammatory markers. There were no significant changes in lung function, quality of life, or exercise tolerance between roflumilast- and placebo-treated groups.
CONCLUSIONS


Roflumilast reduces pulmonary inflammation through decreasing prolyl endopeptidase activity and AcPGP. As expected for lower AcPGP levels, markers of neutrophilic inflammation are blunted. Inhibiting this self-propagating pathway lessens the overall inflammatory burden, which may alter the natural history of COPD, including the risk of exacerbation. Clinical trial registered with www.clinicaltrials.gov (NCT 01572948).",2015,"Roflumilast treatment decreased sputum AcPGP by more than 50% (P < 0.01) and prolyl endopeptidase by 46% (P = 0.02), without significant improvement in leukotriene A4 hydrolase activity compared with placebo.","['chronic obstructive pulmonary disease (COPD', 'Twenty-seven patients were enrolled in the intention-to-treat analysis', 'moderate-to-severe COPD with chronic bronchitis', 'Chronic Obstructive Pulmonary Disease']","['Proline-Glycine-Proline', 'placebo', 'AcPGP', 'Placebo', 'roflumilast treatment added to current therapy', 'Roflumilast']","['prolyl endopeptidase', 'inflammatory markers', 'leukotriene A4 hydrolase activity', 'sputum and blood analyses, pulmonary function testing, exercise tolerance, and quality-of-life assessment', 'lung function, quality of life, or exercise tolerance', 'sputum AcPGP']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0008677', 'cui_str': 'Bronchitis, Chronic'}]","[{'cui': 'C0033382', 'cui_str': 'L-proline'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0965618', 'cui_str': 'Roflumilast'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}]","[{'cui': 'C0072132', 'cui_str': 'prolyl oligopeptidase'}, {'cui': 'C0064844', 'cui_str': 'LTA4 hydrolase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0005768'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}]",27.0,0.120889,"Roflumilast treatment decreased sputum AcPGP by more than 50% (P < 0.01) and prolyl endopeptidase by 46% (P = 0.02), without significant improvement in leukotriene A4 hydrolase activity compared with placebo.","[{'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Wells', 'Affiliation': '1 Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Jackson', 'Affiliation': '1 Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Viera', 'Affiliation': '1 Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine.'}, {'ForeName': 'Surya P', 'Initials': 'SP', 'LastName': 'Bhatt', 'Affiliation': '1 Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Gautney', 'Affiliation': '5 University of Alabama at Birmingham School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama; and.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Handley', 'Affiliation': '5 University of Alabama at Birmingham School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama; and.'}, {'ForeName': 'R Wilson', 'Initials': 'RW', 'LastName': 'King', 'Affiliation': '1 Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': '1 Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Gaggar', 'Affiliation': '1 Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Bailey', 'Affiliation': '1 Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': '1 Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine.'}, {'ForeName': 'J Edwin', 'Initials': 'JE', 'LastName': 'Blalock', 'Affiliation': '1 Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201503-0543OC']
690,32418142,Dual Antiplatelet Therapy Duration in Medically Managed Acute Coronary Syndrome Patients: Sub-Analysis of the OPT-CAD Study.,"INTRODUCTION


Optimal dual antiplatelet therapy (DAPT) duration for medically managed acute coronary syndrome (ACS) (MMACS) patients is still unknown. We explored the efficacy and safety of ≥ 12-month DAPT among MMACS patients.
METHODS


In this sub-analysis of the optimal antiplatelet therapy for Chinese Patients with Coronary Artery Disease study (NCT01735305), clinical outcomes among MMACS patients were compared between the < 12-month and ≥ 12-month DAPT groups. The primary efficacy endpoint was a composite of cardiac death, myocardial infarction, and stroke. Safety endpoints included the Bleeding Academic Research Consortium (BARC) 2-5, BARC 3-5, and all bleeding events. Propensity score matching (PSM) was used to compare baseline characteristics between the < 12-month and ≥ 12-month DAPT groups.
RESULTS


In this cohort of ACS patients (n = 10,016), MMACS patients (n = 2967) were less likely to use DAPT at 12 (31.64% vs. 67.47%, P < 0.0001) and 24 (13.82% vs. 18.71%, P < 0.0001) months and experienced more ischemic events at 12 (4.55% vs. 3.40%, P = 0.006) and 24 (6.88% vs. 5.08%, P = 0.0004) months than those treated with percutaneous coronary intervention (n = 7049). Among MMACS patients, the rate of primary efficacy endpoint occurring within the second year was significantly higher in the < 12-month DAPT group than in the ≥ 12-month group both before (2.88% vs. 1.60%, P = 0.040) and after (3.19% vs. 1.71%, P = 0.045) PSM. After PSM, no significant differences in all bleeding, BARC 2-5, and BARC 3-5 bleeding were found between the groups.
CONCLUSION


MMACS patients with insufficient DAPT management experienced relatively more ischemic events. DAPT for at least 1 year may be beneficial to this special population without significantly increasing the bleeding risks.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT01735305.",2020,"After PSM, no significant differences in all bleeding, BARC 2-5, and BARC 3-5 bleeding were found between the groups.
","['Medically Managed Acute Coronary Syndrome Patients', 'Chinese Patients with Coronary Artery Disease', 'medically managed acute coronary syndrome (ACS) (MMACS) patients']","['DAPT', 'antiplatelet therapy (DAPT) duration', 'percutaneous coronary intervention', 'MMACS']","['rate of primary efficacy endpoint', 'Bleeding Academic Research Consortium (BARC) 2-5, BARC 3-5, and all bleeding events', 'Propensity score matching (PSM', 'bleeding risks', 'ischemic events', 'all bleeding, BARC 2-5, and BARC 3-5 bleeding', 'efficacy and safety of\u2009≥', 'composite of cardiac death, myocardial infarction, and stroke']","[{'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.0365972,"After PSM, no significant differences in all bleeding, BARC 2-5, and BARC 3-5 bleeding were found between the groups.
","[{'ForeName': 'Sicong', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Zaixin', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Miaohan', 'Initials': 'M', 'LastName': 'Qiu', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Bian', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China. han1320288258@qq.com.'}]",Advances in therapy,['10.1007/s12325-020-01376-0']
691,25899314,"A single preoperative dose of diclofenac reduces the intensity of acute postcraniotomy headache and decreases analgesic requirements over five postoperative days in adults: A single center, randomized, blinded trial.","OBJECTIVE


Postcraniotomy headache causes considerable pain and can be difficult to treat. We therefore tested the hypothesis that a single 100-mg preoperative dose of diclofenac reduces the intensity of postcraniotomy headache, and reduces analgesic requirements.
METHODS


200 patients having elective craniotomies were randomly assigned to diclofenac (n = 100) or control (n = 100). Pain severity was assessed by an independent observer using a 10-cm-long visual analog scale the evening of surgery, and on the 1st and 5th postoperative days. Analgesics given during the first five postoperative days were converted to intramuscular morphine equivalents. Results were compared using Mann-Whitney-tests; P < 0.05 was considered statistically significant.
RESULTS


Baseline and surgical characteristics were comparable in the diclofenac and control groups. Visual analog pain scores were slightly, but significantly lower with diclofenac at all times (means and 95% confidence intervals): the evening of surgery, 2.47 (1.8-3.1) vs. 4. 37 (5.0-3.7), (P < 0.001); first postoperative day, 3.98 (3.4-4.6) vs. 5.6 (4.9-6.2) cm (P < 0.001) and 5th postoperative day: 2.8 (2.2-3.4) vs. 4.0 ± (3.3-4.7) cm (P = 0.013). Diclofenac reduced systemic analgesic requirements over the initial five postoperative days (mean and 95% CI): 3.3 (2.6-3.9) vs. 4.3 (3.5-5.1) mg morphine equivalents (P < 0.05).
CONCLUSIONS


Preoperative diclofenac administration reduces postcraniotomy headache and postoperative analgesic requirements - a benefit that persisted throughout five postoperative days.",2015,"Visual analog pain scores were slightly, but significantly lower with diclofenac at all times (means and 95% confidence intervals): the evening of surgery, 2.47 (1.8-3.1) vs. 4. 37 (5.0-3.7), (P < 0.001); first postoperative day, 3.98 (3.4-4.6) vs. 5.6 (4.9-6.2) cm (P < 0.001) and 5th postoperative day: 2.8 (2.2-3.4) vs. 4.0 ± (3.3-4.7) cm (P = 0.013).","['adults', '200 patients having elective craniotomies']","['Diclofenac', 'diclofenac']","['postcraniotomy headache and postoperative analgesic requirements', 'Visual analog pain scores', 'intensity of acute postcraniotomy headache', 'systemic analgesic requirements', 'intensity of postcraniotomy headache', 'analgesic requirements', 'Pain severity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.332795,"Visual analog pain scores were slightly, but significantly lower with diclofenac at all times (means and 95% confidence intervals): the evening of surgery, 2.47 (1.8-3.1) vs. 4. 37 (5.0-3.7), (P < 0.001); first postoperative day, 3.98 (3.4-4.6) vs. 5.6 (4.9-6.2) cm (P < 0.001) and 5th postoperative day: 2.8 (2.2-3.4) vs. 4.0 ± (3.3-4.7) cm (P = 0.013).","[{'ForeName': 'Csilla', 'Initials': 'C', 'LastName': 'Molnár', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University of Debrecen, Health and Medical Science Centre, Hungary. Electronic address: csmolnar@med.unideb.hu.'}, {'ForeName': 'Éva', 'Initials': 'É', 'LastName': 'Simon', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University of Debrecen, Health and Medical Science Centre, Hungary.'}, {'ForeName': 'Ágota', 'Initials': 'Á', 'LastName': 'Kazup', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University of Debrecen, Health and Medical Science Centre, Hungary.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Gál', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University of Debrecen, Health and Medical Science Centre, Hungary.'}, {'ForeName': 'Levente', 'Initials': 'L', 'LastName': 'Molnár', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University of Debrecen, Health and Medical Science Centre, Hungary.'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Novák', 'Affiliation': 'Department of Neurosurgery, University of Debrecen, Health and Medical Science Centre, Hungary.'}, {'ForeName': 'Dániel', 'Initials': 'D', 'LastName': 'Bereczki', 'Affiliation': 'Department of Neurology, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Michael Cudahy Professor and Chair, Department of Outcomes Research, Cleveland Clinic, Cleveland, USA.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Fülesdi', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University of Debrecen, Health and Medical Science Centre, Hungary; Outcomes Research Consortium, Hungary.'}]",Journal of the neurological sciences,['10.1016/j.jns.2015.04.005']
692,31402538,CONTROL: A randomized phase 2 study of obeticholic acid and atorvastatin on lipoproteins in nonalcoholic steatohepatitis patients.,"BACKGROUND & AIMS


Nonalcoholic steatohepatitis (NASH) is a chronic and severe form of nonalcoholic fatty liver disease that can progress to cirrhosis and hepatocellular carcinoma and is a risk factor for cardiovascular disease. Although NASH has no approved treatments, obeticholic acid (OCA), a synthetic bile acid and farnesoid X receptor (FXR) agonist, was shown to improve histological features of NASH and fibrosis. Considering that FXR activation influences plasma lipoprotein concentrations, the Combination OCA aNd sTatins for monitoRing Of Lipids (CONTROL) study evaluated how statins can regulate lipoprotein metabolism with OCA treatment in patients with NASH.
METHODS


This randomized, double-blind, placebo-controlled, phase 2 study began with a 5-week screening/statin washout; 84 patients with NASH were randomly assigned (1:1:1:1) to receive placebo or 5 mg, 10 mg or 25 mg OCA once daily during the 16-week double-blind phase. Concurrent once daily atorvastatin (10 mg/days) was initiated at Week 4 with subsequent titration. Enrolled patients had biopsy-confirmed diagnosis of NASH with no evidence of hepatic decompensation. Plasma was collected to analyse lipoprotein parameters.
RESULTS


At Week 4, all OCA groups had an increase from baseline in mean low-density lipoprotein cholesterol (LDLc) and mean LDL particle concentration (LDLpc), mostly owing to large, less atherogenic LDLc particles. Atorvastatin 10 mg decreased LDLc and LDLpc levels below baseline in all OCA groups by Week 8; higher doses did not provide additional clinical benefits.
CONCLUSIONS


The CONTROL study showed that OCA-induced increases in LDLc in patients with NASH were mitigated with atorvastatin. The combination of OCA and atorvastatin was generally safe and well tolerated (NCT02633956).",2019,The combination of OCA and atorvastatin was generally safe and well-tolerated (NCT02633956).,"['nonalcoholic steatohepatitis patients', '84 patients with NASH', 'patients with NASH', 'Enrolled patients had biopsy-confirmed diagnosis of NASH with no evidence of hepatic decompensation']","['obeticholic acid and atorvastatin', 'atorvastatin', 'Atorvastatin', 'placebo', 'OCA and atorvastatin', 'Nonalcoholic steatohepatitis (NASH', 'NASH', 'OCA']","['LDLc and LDLpc levels', 'mean low-density lipoprotein cholesterol (LDLc) and mean LDL particle concentration (LDLpc), mostly owing to large, less atherogenic LDLc particles', 'LDLc', 'safe and well-tolerated']","[{'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0332125', 'cui_str': 'No evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C1394798', 'cui_str': 'Hepatic decompensation'}]","[{'cui': 'C1143018', 'cui_str': 'obeticholic acid'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",84.0,0.35248,The combination of OCA and atorvastatin was generally safe and well-tolerated (NCT02633956).,"[{'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Pockros', 'Affiliation': 'Division of Gastroenterology/Hepatology, Scripps Clinic, and the Scripps Translational Science Institute, La Jolla, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'Division of Gastroenterology, Virginia Commonwealth University and Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Freilich', 'Affiliation': 'Kansas City Research Institute, Kansas City, MO, USA.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Schiff', 'Affiliation': 'Schiff Center for Liver Diseases, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Kohli', 'Affiliation': 'Institute for Liver Health, Chandler, AZ, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lawitz', 'Affiliation': 'Texas Liver Institute, University of Texas Health San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Hellstern', 'Affiliation': 'Nature Coast Clinical Research, Inverness, FL, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Owens-Grillo', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Van Biene', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Shringarpure', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'MacConell', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shapiro', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Cohen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, NY, USA.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14209']
693,24915259,Hydrolyzed infant formula and early β-cell autoimmunity: a randomized clinical trial.,"IMPORTANCE


The disease process leading to clinical type 1 diabetes often starts during the first years of life. Early exposure to complex dietary proteins may increase the risk of β-cell autoimmunity in children at genetic risk for type 1 diabetes. Extensively hydrolyzed formulas do not contain intact proteins.
OBJECTIVE


To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of diabetes-associated autoantibodies in young children.
DESIGN, SETTING, AND PARTICIPANTS


A double-blind randomized clinical trial of 2159 infants with HLA-conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007 in 78 study centers in 15 countries; 1078 were randomized to be weaned to the extensively hydrolyzed casein formula and 1081 were randomized to be weaned to a conventional cows' milk-based formula. The participants were observed to April 16, 2013.
INTERVENTIONS


The participants received either a casein hydrolysate or a conventional cows' milk formula supplemented with 20% of the casein hydrolysate.
MAIN OUTCOMES


AND MEASURES: Primary outcome was positivity for at least 2 diabetes-associated autoantibodies out of 4 analyzed. Autoantibodies to insulin, glutamic acid decarboxylase, and the insulinoma-associated-2 (IA-2) molecule were analyzed using radiobinding assays and islet cell antibodies with immunofluorescence during a median observation period of 7.0 years (mean, 6.3 years).
RESULTS


The absolute risk of positivity for 2 or more islet autoantibodies was 13.4% among those randomized to the casein hydrolysate formula (n = 139) vs 11.4% among those randomized to the conventional formula (n = 117). The unadjusted hazard ratio for positivity for 2 or more autoantibodies among those randomized to be weaned to the casein hydrolysate was 1.21 (95% CI, 0.94-1.54), compared with those randomized to the conventional formula, while the hazard ratio adjusted for HLA risk, duration of breastfeeding, vitamin D use, study formula duration and consumption, and region was 1.23 (95% CI, 0.96-1.58). There were no clinically significant differences in the rate of reported adverse events between the 2 groups.
CONCLUSIONS AND RELEVANCE


Among infants at risk for type 1 diabetes, the use of a hydrolyzed formula, when compared with a conventional formula, did not reduce the incidence of diabetes-associated autoantibodies after 7 years. These findings do not support a benefit from hydrolyzed formula. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00179777.",2014,"Among infants at risk for type 1 diabetes, the use of a hydrolyzed formula, when compared with a conventional formula, did not reduce the incidence of diabetes-associated autoantibodies after 7 years.","['children at genetic risk for type 1 diabetes', 'young children', '2159 infants with HLA-conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007 in 78 study centers in 15 countries; 1078']","['hydrolyzed casein formula', 'casein hydrolysate formula', ""casein hydrolysate or a conventional cows' milk formula supplemented with 20% of the casein hydrolysate"", ""conventional cows' milk-based formula"", 'Hydrolyzed infant formula and early β-cell autoimmunity']","['unadjusted hazard ratio for positivity', 'positivity for at least 2 diabetes-associated autoantibodies', 'incidence of diabetes-associated autoantibodies', 'cumulative incidence of diabetes-associated autoantibodies', 'hazard ratio adjusted for HLA risk, duration of breastfeeding, vitamin D use, study formula duration and consumption, and region', 'rate of reported adverse events', 'absolute risk of positivity for 2 or more islet autoantibodies']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0054845', 'cui_str': 'casein hydrolysate'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150589', 'cui_str': 'Baby Formula'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0004368', 'cui_str': 'Autoimmunity'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0004358', 'cui_str': 'Autoantibodies'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",2159.0,0.147124,"Among infants at risk for type 1 diabetes, the use of a hydrolyzed formula, when compared with a conventional formula, did not reduce the incidence of diabetes-associated autoantibodies after 7 years.","[{'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Knip', 'Affiliation': 'University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Hans K', 'Initials': 'HK', 'LastName': 'Åkerblom', 'Affiliation': 'University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Becker', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Hans-Michael', 'Initials': 'HM', 'LastName': 'Dosch', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Dupre', 'Affiliation': 'University of Western Ontario, London, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Fraser', 'Affiliation': 'University of Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Howard', 'Affiliation': ""Children's Hospital of Westmead, Sydney, Australia.""}, {'ForeName': 'Jorma', 'Initials': 'J', 'LastName': 'Ilonen', 'Affiliation': 'University of Turku, Turku, Finland.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Krischer', 'Affiliation': 'University of South Florida, Tampa.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Kordonouri', 'Affiliation': 'Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Lawson', 'Affiliation': ""Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Jerry P', 'Initials': 'JP', 'LastName': 'Palmer', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Erkki', 'Initials': 'E', 'LastName': 'Savilahti', 'Affiliation': 'University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Vaarala', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Suvi M', 'Initials': 'SM', 'LastName': 'Virtanen', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2014.5610']
694,24366582,Sputum PGP is reduced by azithromycin treatment in patients with COPD and correlates with exacerbations.,"RATIONALE


Proline-glycine-proline (PGP), a neutrophil chemoattractant derived from the enzymatic breakdown of collagen, is elevated in sputum of patients with chronic obstructive pulmonary disease (COPD) and may contribute to disease progression. Whether sputum levels of PGP respond to therapy for COPD or predict outcomes is unknown.
OBJECTIVES


We conducted a study ancillary to a multicenter trial of the efficacy of azithromycin treatment for 1 year in preventing COPD exacerbations to test whether sputum levels of PGP were altered by treatment or associated with exacerbation frequency.
METHODS


We collected remnant sputa from trial participants and assayed them in a blinded fashion for PGP, myeloperoxidase and matrix metalloproteinase (MMP)-9 and for the ability to generate PGP from collagen ex vivo. Once the parent trial was unblinded, the results were correlated with use of azithromycin or placebo and exacerbations in participants.
RESULTS


Azithromycin treatment significantly reduced sputum levels of PGP and myeloperoxidase in patients with COPD, particularly with increased duration of therapy. We found no difference in sputum MMP-9 or PGP generation between participants taking azithromycin or placebo. Sputum PGP levels were highest around the time of an exacerbation and declined with successful treatment.
CONCLUSIONS


These data support a role for PGP in the airway and parenchymal neutrophilic inflammation that drives COPD progression and exacerbations, and provide new information on the anti-inflammatory properties of macrolides. PGP may have potential as a target for novel anti-inflammatory therapies in COPD and as a biomarker for clinical trials.",2013,"RESULTS


Azithromycin treatment significantly reduced sputum levels of PGP and myeloperoxidase in patients with COPD, particularly with increased duration of therapy.","['patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD', 'patients with COPD and correlates with exacerbations']","['azithromycin', 'Azithromycin', 'PGP', 'azithromycin or placebo', 'glycine-proline (PGP']","['sputum MMP-9 or PGP generation', 'duration of therapy', 'Sputum PGP levels', 'COPD exacerbations', 'sputum levels of PGP and myeloperoxidase']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0033382', 'cui_str': 'L-proline'}]","[{'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0444917', 'cui_str': 'Duration of therapy (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}]",,0.131843,"RESULTS


Azithromycin treatment significantly reduced sputum levels of PGP and myeloperoxidase in patients with COPD, particularly with increased duration of therapy.","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': ""O'Reilly"", 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Jackson', 'Affiliation': ''}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Wells', 'Affiliation': ''}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': ''}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Scanlon', 'Affiliation': ''}, {'ForeName': 'J Edwin', 'Initials': 'JE', 'LastName': 'Blalock', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2013-004140']
695,24216218,Recruitment and retention of participants for an international type 1 diabetes prevention trial: a coordinators' perspective.,"BACKGROUND


The Trial to Reduce Insulin Dependent Diabetes Mellitus in the Genetically at Risk (TRIGR) is the first multicenter international type 1 diabetes (T1D) prevention trial to be undertaken. A unique feature of TRIGR has been recruitment of eligible pregnant women and enrollment of newborns for long-term follow-up assessments.
PURPOSE


Our purpose is to summarize the recruitment and retention strategies used to conduct TRIGR from the perspective of the study coordinators.
METHODS


TRIGR was designed to test whether weaning to formula containing hydrolyzed versus intact cow's milk protein would be efficacious in decreasing risk for development of T1D-associated autoantibodies and T1D among infants identified to be at increased risk for T1D based on their human leukocyte antigen (HLA) profile and family history. Multiple strategies tailored to local issues were required to enroll and follow the target number of infants.
RESULTS


This study was conducted in the United States, Canada, Australia, and 12 countries in Europe. Of the 5606 mothers registered worldwide, 5000 of their infants were randomized. Of these, 2159 were HLA eligible and enrolled in the 8-month intervention and 10-year follow-up phases of this study. The TRIGR study met the accrual goal after 4.7 years of recruitment, 2.7 years longer than projected initially. Challenges included difficulty in finding fathers with T1D, a higher than expected rate of premature delivery among T1D mothers, and implementation of new privacy regulations mid-trial. The majority of participants were recruited from primary care antenatal clinics located near the study centers and from a general hospital or pediatric center that was affiliated with a TRIGR Study center. Internet and magazine advertisements were found to be useful for recruitment of families. Alternative follow-up strategies are offered to families who wish to reduce or discontinue participation.
LIMITATIONS


Our experience is limited to a single international multicenter trial.
CONCLUSIONS


TRIGR coordinators played key roles in the recruitment and intervention periods and continue to be instrumental in retaining families and children during the 10-year follow-up period for each child.",2014,"BACKGROUND


The Trial to Reduce Insulin Dependent Diabetes Mellitus in the Genetically at Risk (TRIGR) is the first multicenter international type 1 diabetes (T1D) prevention trial to be undertaken.","['United States, Canada, Australia, and 12 countries in Europe', '2159 were HLA eligible and enrolled in the 8-month intervention and 10-year follow-up phases of this study', '5606 mothers registered worldwide, 5000 of their infants were randomized', 'participants were recruited from primary care antenatal clinics located near the study centers and from a general hospital or pediatric center that was affiliated with a TRIGR Study center', 'families who wish to reduce or discontinue participation', 'eligible pregnant women and enrollment of newborns for long-term follow-up assessments']",[],[],"[{'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C4319610', 'cui_str': '5000 (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",[],[],5606.0,0.0696763,"BACKGROUND


The Trial to Reduce Insulin Dependent Diabetes Mellitus in the Genetically at Risk (TRIGR) is the first multicenter international type 1 diabetes (T1D) prevention trial to be undertaken.","[{'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Franciscus', 'Affiliation': 'aDepartment of Pediatric Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Nucci', 'Affiliation': ''}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Bradley', 'Affiliation': ''}, {'ForeName': 'Heli', 'Initials': 'H', 'LastName': 'Suomalainen', 'Affiliation': ''}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Greenberg', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Laforte', 'Affiliation': ''}, {'ForeName': 'Paivi', 'Initials': 'P', 'LastName': 'Kleemola', 'Affiliation': ''}, {'ForeName': 'Mila', 'Initials': 'M', 'LastName': 'Hyytinen', 'Affiliation': ''}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Salonen', 'Affiliation': ''}, {'ForeName': 'Mary Jean', 'Initials': 'MJ', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Catte', 'Affiliation': ''}, {'ForeName': 'Jacki', 'Initials': 'J', 'LastName': 'Catteau', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical trials (London, England)",['10.1177/1740774513510070']
696,23705963,Effects of a brief Qigong-based stress reduction program (BQSRP) in a distressed Korean population: a randomized trial.,"BACKGROUND


Distressed individuals in Korea may benefit from the practice of mind-body exercises such as Qigong. However, the effectiveness of such techniques needs to be investigated.
METHODS


Fifty participants who were eligible to this study were randomized into a group receiving a 4-week intervention of a brief Qigong-based stress reduction program (BQSRP) or a wait-list control group. Before and after the intervention period, saliva samples were collected and questionnaires were completed on perceived stress, anxiety, ""Hwa-Byung"" (anger syndrome), and quality of life. Salivary cortisol has emerged in mind-body therapy research as an easy-to-collect, relatively inexpensive, biologic marker of stress. Salivary corisol were collected to evaluate physiological effect of BQSRP. Between-group comparisons of change from baseline to study completion were analyzed by analysis of covariance for the Perceived Stress Scale and independent two sample t-tests for other measures.
RESULTS


Compared with the control group, the BQSRP intervention group displayed significantly larger decreases in Perceived Stress Scale scores (p = 0.0006), State Anxiety scores (p = 0.0028), Trait Anxiety scores (p < 0.0001), personality subscale scores of the Hwa-Byung Scale (p = 0.0321), symptoms scores of the Hwa-Byung Scale (p = 0.0196), and a significantly larger increase in World Health Organization Quality of Life Abbreviated version scores (ps < .05). Salivary cortisol levels were not changed.
CONCLUSIONS


The BQSRP appears to be effective in reducing stress perception, anxiety, anger, and improving quality of life (KCT0000056).",2013,"Compared with the control group, the BQSRP intervention group displayed significantly larger decreases in Perceived Stress Scale scores (p = 0.0006), State Anxiety scores (p = 0.0028), Trait Anxiety scores (p < 0.0001), personality subscale scores of the Hwa-Byung Scale (p = 0.0321), symptoms scores of the Hwa-Byung Scale (p = 0.0196), and a significantly larger increase in World Health Organization Quality of Life Abbreviated version scores (ps < .05).","['Fifty participants who were eligible to this study', 'Distressed individuals in Korea', 'distressed Korean population']","['BQSRP', 'BQSRP intervention', 'brief Qigong-based stress reduction program (BQSRP', 'brief Qigong-based stress reduction program (BQSRP) or a wait-list control group']","['symptoms scores of the Hwa-Byung Scale', 'State Anxiety scores', 'World Health Organization Quality of Life Abbreviated version scores', 'Salivary cortisol levels', 'personality subscale scores of the Hwa-Byung Scale', 'perceived stress, anxiety, ""Hwa-Byung"" (anger syndrome), and quality of life', 'stress perception, anxiety, anger, and improving quality of life', 'Perceived Stress Scale scores', 'Trait Anxiety scores']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0282077', 'cui_str': ""Ch'i Kung""}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0520690', 'cui_str': 'Hwa-byung (disorder)'}, {'cui': 'C0222045'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0034380'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0031208', 'cui_str': 'Personality'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C4304048', 'cui_str': 'PSS (Perceived Stress Scale) score'}]",50.0,0.0385801,"Compared with the control group, the BQSRP intervention group displayed significantly larger decreases in Perceived Stress Scale scores (p = 0.0006), State Anxiety scores (p = 0.0028), Trait Anxiety scores (p < 0.0001), personality subscale scores of the Hwa-Byung Scale (p = 0.0321), symptoms scores of the Hwa-Byung Scale (p = 0.0196), and a significantly larger increase in World Health Organization Quality of Life Abbreviated version scores (ps < .05).","[{'ForeName': 'Eun-Young', 'Initials': 'EY', 'LastName': 'Hwang', 'Affiliation': 'Departments of Korean Neuropsychiatry, College of Korean Medicine and Institute of Korean Medicine, Kyung Hee University, 1 Hoegi-dong, Dongdaemun-gu, Seoul 130-701, Republic of Korea.'}, {'ForeName': 'Sun-Yong', 'Initials': 'SY', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Jae-Heung', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'Mi-Yeon', 'Initials': 'MY', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Sehyun', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jong-Woo', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': ''}]",BMC complementary and alternative medicine,['10.1186/1472-6882-13-113']
697,32427325,"Congruence Gaps Between Adolescents With Cancer and Their Families Regarding Values, Goals, and Beliefs About End-of-Life Care.","Importance


Lack of pediatric advance care planning has been associated with poor communication, increased hospitalization, poor quality of life, and legal actions. Clinicians presume that families understand adolescents' treatment preferences for end-of-life care.
Objective


To examine patient-reported end-of-life values and needs of adolescents with cancer and congruence with their families' understanding of these needs.
Design, Setting, and Participants


This cross-sectional survey was conducted among adolescent-family dyads from July 16, 2016, to April 30, 2019, at 4 tertiary care pediatric US hospitals. Participants included 80 adolescent-family dyads (160 participants) within a larger study facilitating pediatric advance care planning. Adolescent eligibility criteria included being aged 14 to 21 years, English speaking, being diagnosed with cancer at any stage, and knowing their diagnosis. Family included legal guardians for minors or chosen surrogate decision-makers for those aged 18 years or older. Data analysis was performed from April 2019 to November 2019.
Exposure


Session 1 of the 3-session Family Centered Pediatric Advance Care Planning for Teens With Cancer intervention.
Main Outcomes and Measures


The main outcome was congruence between adolescents with cancer and their families regarding adolescents' values, goals, and beliefs about end-of-life care. Prevalence-adjusted and bias-adjusted κ (PABAK) values were used to measure congruence on the Lyon Advance Care Planning Survey-Revised (Patient and Surrogate versions).
Results


A total of 80 adolescent-family dyads (160 participants) were randomized to the intervention group in the original trial. Among the adolescents, 44 (55.0%) were female and 60 (75.0%) were white, with a mean (SD) age of 16.9 (1.8) years. Among family members, 66 (82.5%) were female and 65 (81.3%) were white, with a mean (SD) age of 45.3 (8.3) years. Family members' understanding of their adolescent's beliefs about the best time bring up end-of-life decisions was poor: 86% of adolescents wanted early timing (before getting sick, while healthy, when first diagnosed, when first sick from a life-threatening illness, or all of the above), but only 39% of families knew this (PABAK, 0.18). Families' understanding of what was important to their adolescents when dealing with their own dying was excellent for wanting honest answers from their physician (PABAK, 0.95) and understanding treatment choices (PABAK, 0.95) but poor for dying a natural death (PABAK, 0.18) and being off machines that extend life, if dying (PABAK, 0).
Conclusions and Relevance


Many families had a poor understanding of their adolescent's values regarding their own end-of-life care, such as when to initiate end-of-life conversations and preference for being off machines that extend life. Pediatric advance care planning could minimize these misunderstandings with the potential for a substantial impact on quality of care.",2020,"Families' understanding of what was important to their adolescents when dealing with their own dying was excellent for wanting honest answers from their physician (PABAK, 0.95) and understanding treatment choices (PABAK, 0.95) but","['Family included legal guardians for minors or chosen surrogate decision-makers for those aged 18 years or older', 'Teens With Cancer intervention', 'Among the adolescents, 44 (55.0%) were female and 60 (75.0%) were white, with a mean (SD) age of 16.9 (1.8) years', 'Participants\n\n\nThis cross-sectional survey was conducted among adolescent-family dyads from July 16, 2016, to April 30, 2019, at 4 tertiary care pediatric US hospitals', 'adolescents with cancer and congruence with their families', 'Participants included 80 adolescent-family dyads (160 participants) within a larger study facilitating pediatric advance care planning', 'Among family members, 66 (82.5%) were female and 65 (81.3%) were white, with a mean (SD) age of 45.3 (8.3) years', 'Adolescent eligibility criteria included being aged 14 to 21 years, English speaking, being diagnosed with cancer at any stage, and knowing their diagnosis', '80 adolescent-family dyads (160 participants']",['3-session Family Centered Pediatric Advance Care Planning'],"['hospitalization, poor quality of life, and legal actions', 'Prevalence-adjusted and bias-adjusted κ (PABAK) values', ""adolescents with cancer and their families regarding adolescents' values, goals, and beliefs about end-of-life care""]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0554244', 'cui_str': 'Maker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C4517887', 'cui_str': '82.5'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205309', 'cui_str': 'Known'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1301860', 'cui_str': 'Legal'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0039548', 'cui_str': 'Terminal care'}]",80.0,0.0323796,"Families' understanding of what was important to their adolescents when dealing with their own dying was excellent for wanting honest answers from their physician (PABAK, 0.95) and understanding treatment choices (PABAK, 0.95) but","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Friebert', 'Affiliation': ""Haslinger Family Pediatric Palliative Care Center, Akron Children's Hospital, Akron, Ohio.""}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Grossoehme', 'Affiliation': ""Haslinger Family Pediatric Palliative Care Center, Akron Children's Hospital, Akron, Ohio.""}, {'ForeName': 'Justin N', 'Initials': 'JN', 'LastName': 'Baker', 'Affiliation': 'Division of Quality of Life and Palliative Care, St Jude Research Hospital, Memphis, Tennessee.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Needle', 'Affiliation': 'Center for Bioethics, Department of Pediatrics, University of Minnesota, Minneapolis.'}, {'ForeName': 'Jessica D', 'Initials': 'JD', 'LastName': 'Thompkins', 'Affiliation': ""Center for Translational Research, Children's Research Institute, Children's National Hospital, Washington, DC.""}, {'ForeName': 'Yao I', 'Initials': 'YI', 'LastName': 'Cheng', 'Affiliation': ""Division of Biostatistics and Study Methodology, Center for Translational Research, Children's Research Institute, Children's National Hospital, Washington, DC.""}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Division of Biostatistics and Study Methodology, Center for Translational Research, Children's Research Institute, Children's National Hospital, Washington, DC.""}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Lyon', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, DC.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.5424']
698,23039709,Implementing a simplified neonatal resuscitation protocol-helping babies breathe at birth (HBB) - at a tertiary level hospital in Nepal for an increased perinatal survival.,"BACKGROUND


Reducing neonatal death has been an emerging challenge in low and middle income countries in the past decade. The development of the low cost interventions and their effective delivery are needed to reduce deaths from birth asphyxia. This study will assess the impact of a simplified neonatal resuscitation protocol provided by Helping Babies Breathe (HBB) at a tertiary hospital in Nepal. Perinatal outcomes and performance of skilled birth attendants on management of intrapartum-related neonatal hypoxia will be the main measurements.
METHODS/DESIGN


The study will be carried out at a tertiary level maternity hospital in Nepal. A prospective cohort-study will include a six-month baseline a six month intervention period and a three-month post intervention period. A quality improvement process cycle will introduce the neonatal resuscitation protocol. A surveillance system, including CCD cameras and pulse oximeters, will be set up to evaluate the intervention.
DISCUSSION


Along with a technique to improve health workers performance on the protocol, the study will generate evidence on the research gap on the effectiveness of the simplified neonatal resuscitation protocol on intrapartum outcome and early neonatal survival. This will generate a global interest and inform policymaking in relation to delivery care in all income settings.
TRIAL REGISTRATION


ISRCTN97846009.",2012,This study will assess the impact of a simplified neonatal resuscitation protocol provided by Helping Babies Breathe (HBB) at a tertiary hospital in Nepal.,"['Babies Breathe (HBB) at a tertiary hospital in Nepal', 'tertiary level maternity hospital in Nepal']",[],"['health workers performance', 'intrapartum outcome and early neonatal survival']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0020010', 'cui_str': 'Hospitals, Maternity'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.070139,This study will assess the impact of a simplified neonatal resuscitation protocol provided by Helping Babies Breathe (HBB) at a tertiary hospital in Nepal.,"[{'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Ashish', 'Affiliation': ""International Maternal and Child Health, Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden. ashish.k.c@kbh.uu.se""}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Målqvist', 'Affiliation': ''}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Wrammert', 'Affiliation': ''}, {'ForeName': 'Sheela', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ''}, {'ForeName': 'Dhan Raj', 'Initials': 'DR', 'LastName': 'Aryal', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'P K C', 'Initials': 'PK', 'LastName': 'Naresh', 'Affiliation': ''}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Vitrakoti', 'Affiliation': ''}, {'ForeName': 'Kedar', 'Initials': 'K', 'LastName': 'Baral', 'Affiliation': ''}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Ewald', 'Affiliation': ''}]",BMC pediatrics,['10.1186/1471-2431-12-159']
699,32065620,Vascular effects of serelaxin in patients with stable coronary artery disease: a randomized placebo-controlled trial.,"AIMS


The effects of serelaxin, a recombinant form of human relaxin-2 peptide, on vascular function in the coronary microvascular and systemic macrovascular circulation remain largely unknown. This mechanistic, clinical study assessed the effects of serelaxin on myocardial perfusion, aortic stiffness, and safety in patients with stable coronary artery disease (CAD).
METHODS AND RESULTS


In this multicentre, double-blind, parallel-group, placebo-controlled study, 58 patients were randomized 1:1 to 48 h intravenous infusion of serelaxin (30 µg/kg/day) or matching placebo. The primary endpoints were change from baseline to 47 h post-initiation of the infusion in global myocardial perfusion reserve (MPR) assessed using adenosine stress perfusion cardiac magnetic resonance imaging, and applanation tonometry-derived augmentation index (AIx). Secondary endpoints were: change from baseline in AIx and pulse wave velocity, assessed at 47 h, Day 30, and Day 180; aortic distensibility at 47 h; pharmacokinetics and safety. Exploratory endpoints were the effect on cardiorenal biomarkers [N-terminal pro-brain natriuretic peptide (NT-proBNP), high-sensitivity troponin T (hsTnT), endothelin-1, and cystatin C]. Of 58 patients, 51 were included in the primary analysis (serelaxin, n = 25; placebo, n = 26). After 2 and 6 h of serelaxin infusion, mean placebo-corrected blood pressure reductions of -9.6 mmHg (P = 0.01) and -13.5 mmHg (P = 0.0003) for systolic blood pressure and -5.2 mmHg (P = 0.02) and -8.4 mmHg (P = 0.001) for diastolic blood pressure occurred. There were no between-group differences from baseline to 47 h in global MPR (-0.24 vs. -0.13, P = 0.44) or AIx (3.49% vs. 0.04%, P = 0.21) with serelaxin compared with placebo. Endothelin-1 and cystatin C levels decreased from baseline in the serelaxin group, and there were no clinically relevant changes observed with serelaxin for NT-proBNP or hsTnT. Similar numbers of serious adverse events were observed in both groups (serelaxin, n = 5; placebo, n = 7) to 180-day follow-up.
CONCLUSION


In patients with stable CAD, 48 h intravenous serelaxin reduced blood pressure but did not alter myocardial perfusion.",2020,"Endothelin-1 and cystatin C levels decreased from baseline in the serelaxin group, and there were no clinically relevant changes observed with serelaxin for NT-proBNP or hsTnT. Similar numbers of serious adverse events were observed in both groups (serelaxin, n = 5; placebo, n = 7) to 180-day follow-up.
","['patients with stable coronary artery disease', 'patients with stable coronary artery disease (CAD', 'Of 58 patients, 51 were included in the primary analysis (serelaxin, n\u2009=\u200925; placebo, n\u2009=\u200926', '58 patients']","['placebo', 'serelaxin', 'matching placebo']","['serious adverse events', 'cardiorenal biomarkers [N-terminal pro-brain natriuretic peptide (NT-proBNP), high-sensitivity troponin T (hsTnT), endothelin-1, and cystatin C', 'systolic blood pressure', 'diastolic blood pressure', 'myocardial perfusion', 'blood pressure reductions', 'Endothelin-1 and cystatin C levels', 'change from baseline in AIx and pulse wave velocity, assessed at 47\u2009h, Day 30, and Day 180; aortic distensibility at 47\u2009h; pharmacokinetics and safety', 'change from baseline to 47\u2009h post-initiation of the infusion in global myocardial perfusion reserve (MPR) assessed using adenosine stress perfusion cardiac magnetic resonance imaging, and applanation tonometry-derived augmentation index (AIx', 'blood pressure', 'global MPR', 'myocardial perfusion, aortic stiffness, and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C3700393'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3700393'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0999177', 'cui_str': 'Genus Aix (organism)'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0430862', 'cui_str': 'Applanation tonometry (procedure)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1701620', 'cui_str': 'mercaptopropionyl-phenylalanyl-cyclohexylalanyl-cyclohexylalanyl-arginyl-lysyl-prolyl-asparaginyl-aspartyl-lysinamide'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}]",58.0,0.617518,"Endothelin-1 and cystatin C levels decreased from baseline in the serelaxin group, and there were no clinically relevant changes observed with serelaxin for NT-proBNP or hsTnT. Similar numbers of serious adverse events were observed in both groups (serelaxin, n = 5; placebo, n = 7) to 180-day follow-up.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Corcoran', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Radjenovic', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Ify R', 'Initials': 'IR', 'LastName': 'Mordi', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Sheraz A', 'Initials': 'SA', 'LastName': 'Nazir', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and NIHR Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Wilson', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hinder', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Denise P', 'Initials': 'DP', 'LastName': 'Yates', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Surendra', 'Initials': 'S', 'LastName': 'Machineni', 'Affiliation': 'Novartis Healthcare Private Limited, Hyderabad, India.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Alcantara', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Margaret F', 'Initials': 'MF', 'LastName': 'Prescott', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gugliotta', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Yinuo', 'Initials': 'Y', 'LastName': 'Pang', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Niko', 'Initials': 'N', 'LastName': 'Tzemos', 'Affiliation': 'London Health Science Centre, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Scott I', 'Initials': 'SI', 'LastName': 'Semple', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Gerry P', 'Initials': 'GP', 'LastName': 'McCann', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and NIHR Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Squire', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and NIHR Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}]",Cardiovascular research,['10.1093/cvr/cvz345']
700,32422373,Add-On Omalizumab for Inadequately Controlled Severe Pollinosis Despite Standard-of-Care: A Randomized Study.,"BACKGROUND


Cedar pollinosis (CP), a common form of seasonal allergic rhinitis (AR), is a substantial medical problem in Japan due to its high prevalence and severe symptoms. Omalizumab (anti-IgE therapy) has previously proven to be effective in CP/AR, but no studies for inadequately controlled severe CP/AR despite standard-of-care (SoC) have been conducted.
OBJECTIVE


To determine the efficacy of omalizumab added to SoC in patients with inadequately controlled severe CP in a randomized, double-blinded, placebo-controlled, phase III study.
METHODS


Adult/adolescent patients with severe CP whose symptoms were inadequately controlled despite nasal corticosteroids plus 1 or more oral medications in the previous 2 seasons were randomized to receive omalizumab (n = 162) or placebo (n = 175). All patients received concomitant antihistamines and nasal corticosteroids as SoC. The primary endpoint was the mean nasal symptom score during the severe symptom period. Secondary endpoints included mean ocular symptom score, quality of life (QoL), and safety.
RESULTS


The SoC + omalizumab treatment had statistically significantly and clinically important lower nasal (least squares mean difference, -1.03, P < .001) and ocular (-0.87, P < .001) symptom scores compared with SoC + placebo, respectively. Differences in scores for individual components of nasal and ocular symptoms were also statistically and clinically significant. SoC + omalizumab also improved QoL scores as overall and in all domains. No unexpected safety signals were observed.
CONCLUSIONS


In patients with severe CP, omalizumab added to SoC demonstrated consistent efficacy in improving symptoms and QoL, and was well tolerated. These results indicate that omalizumab could be a promising therapeutic option for severe CP/AR.",2020,"The SoC + omalizumab treatment had statistically significantly and clinically important lower nasal (LS mean difference, -1.03, p<0.001) and ocular (-0.87, p<0.001) symptom scores compared with SoC + placebo respectively.","['Severe adult/adolescent CP patients whose symptoms were inadequately controlled despite nasal corticosteroids plus one or more oral medications in the previous two seasons', 'Cedar pollinosis (CP', 'patients with inadequately controlled severe CP']","['Omalizumab (anti-IgE therapy', 'concomitant antihistamines and nasal corticosteroids as SoC', 'SoC + Omalizumab', 'omalizumab', 'SoC + placebo', 'placebo']","['individual components of nasal and ocular symptoms', 'QoL scores', 'mean ocular symptom score, quality-of-life, and safety', 'mean nasal symptom score']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0051978', 'cui_str': 'Anti-Immunoglobulin E antibody'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}]",175.0,0.216499,"The SoC + omalizumab treatment had statistically significantly and clinically important lower nasal (LS mean difference, -1.03, p<0.001) and ocular (-0.87, p<0.001) symptom scores compared with SoC + placebo respectively.","[{'ForeName': 'Kimihiro', 'Initials': 'K', 'LastName': 'Okubo', 'Affiliation': 'Department of Otolaryngology, Nippon Medical School, Tokyo, Japan. Electronic address: ent-kimi@nms.ac.jp.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Okano', 'Affiliation': 'Department of Otorhinolaryngology, International University of Health and Welfare School of Medicine, Narita, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Sato', 'Affiliation': 'Novartis Pharma K.K., Tokyo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Tamaki', 'Affiliation': 'Novartis Pharma K.K., Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Novartis Pharma K.K., Tokyo, Japan.'}, {'ForeName': 'Alkaz', 'Initials': 'A', 'LastName': 'Uddin', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.04.068']
701,32423275,Pharmacokinetic Study of Epinephrine Hydrofluoroalkane (Primatene MIST) Metered-Dose Inhaler.,"Background :  Primatene ®  MIST CFC, an epinephrine metered-dose inhaler (MDI), was discontinued from the market owing to environmental concerns from its use of chlorofluorocarbon (CFC) propellant. As a result, a new epinephrine MDI was developed using hydrofluoroalkane (HFA) propellant. This article reports the pharmacokinetic (PK) profile of the newly Food and Drug Administration-approved epinephrine HFA MDI.  Methods :  A randomized, evaluator-blinded, active-controlled, single-dose, two-arm crossover study was conducted to evaluate the PK profile of epinephrine HFA (Primatene ®  MIST) and epinephrine CFC (Primatene ®  MIST CFC) in 23 healthy volunteers to characterize the epinephrine absorption extent and rate. The study was performed at a high dose of five times the normal dose to obtain measurable plasma epinephrine levels. Plasma epinephrine levels were measured and safety was assessed by adverse events (AEs), vital signs, clinical laboratory tests, and physical examinations.  Results : Epinephrine HFA demonstrated a greater systemic drug exposure (greater area under the curve) than that of epinephrine CFC (∼37% higher). The  C max  occurred at ∼2 minutes and was significantly higher in the epinephrine HFA group (0.18 ng/mL) compared with the CFC version (0.046 ng/mL) at normal dose. Within 20 minutes, both groups demonstrated comparable plasma epinephrine levels. No clinically significant adverse effects were found to be associated with epinephrine HFA, even after an ultrahigh dose (i.e., 10 inhalations).  Conclusions:  The systemic exposure of epinephrine HFA was found to be higher for the first 20 minutes, and then comparable with epinephrine CFC. Minimal AEs were found in this study despite the very high 1250-2200 μg inhaled doses (i.e., 10 inhalations) used for PK characterization.",2020,Epinephrine HFA demonstrated a greater systemic drug exposure (greater area under the curve) than that of epinephrine CFC (∼37% higher).,['23 healthy volunteers'],"['epinephrine metered-dose inhaler (MDI', 'chlorofluorocarbon (CFC) propellant', 'hydrofluoroalkane (HFA) propellant', 'epinephrine HFA (Primatene ®  MIST) and epinephrine CFC (Primatene ®  MIST CFC', 'epinephrine HFA', 'Epinephrine Hydrofluoroalkane (Primatene MIST', 'epinephrine CFC', 'Epinephrine HFA']","['adverse events (AEs), vital signs, clinical laboratory tests, and physical examinations', 'plasma epinephrine levels', 'systemic drug exposure', 'Plasma epinephrine levels', 'adverse effects', 'C max']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0162787', 'cui_str': 'Chlorofluorocarbon'}, {'cui': 'C0015458', 'cui_str': 'Facial hemiatrophy'}, {'cui': 'C0722799', 'cui_str': 'Primatene'}, {'cui': 'C1275081', 'cui_str': 'Cardio-facio-cutaneous syndrome'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1275469', 'cui_str': 'Plasma epinephrine measurement'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",23.0,0.141648,Epinephrine HFA demonstrated a greater systemic drug exposure (greater area under the curve) than that of epinephrine CFC (∼37% higher).,"[{'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Kerwin', 'Affiliation': 'Clinical Research Institute of Southern Oregon, Medford, Oregon, USA.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Marrs', 'Affiliation': 'Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California, USA.'}, {'ForeName': 'Mary Z', 'Initials': 'MZ', 'LastName': 'Luo', 'Affiliation': 'Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California, USA.'}, {'ForeName': 'Jack Y', 'Initials': 'JY', 'LastName': 'Zhang', 'Affiliation': 'Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California, USA.'}]",Journal of aerosol medicine and pulmonary drug delivery,['10.1089/jamp.2019.1577']
702,32422097,"In irritable bowel syndrome, fecal microbiota transplantation improved symptoms at 3 months.","SOURCE CITATION


El-Salhy M, Hatlebakk JG, Gilja OH, Bråthen Kristoffersen A, Hausken T.  Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study.  Gut. 2020;69:859-67. 31852769.",2020,"SOURCE CITATION


El-Salhy M, Hatlebakk JG, Gilja OH, Bråthen Kristoffersen A,",['patients with irritable bowel syndrome'],"['faecal microbiota transplantation', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0812731,"SOURCE CITATION


El-Salhy M, Hatlebakk JG, Gilja OH, Bråthen Kristoffersen A,","[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Talley', 'Affiliation': 'University of Newcastle, Newcastle, New South Wales, Australia (N.J.T., M.I.).'}, {'ForeName': 'Mudar', 'Initials': 'M', 'LastName': 'Irani', 'Affiliation': 'University of Newcastle, Newcastle, New South Wales, Australia (N.J.T., M.I.).'}]",Annals of internal medicine,['10.7326/ACPJ202005190-052']
703,22573418,Telephone-delivered health education and interpersonal counseling improve quality of life for Latinas with breast cancer and their supportive partners.,"OBJECTIVE


This study aims to test two telephone-delivered interventions for their efficacy in improving quality of life (QOL) (psychological, physical, social, and spiritual) among Latinas with breast cancer and their family members or friends (labeled supportive partners in this study).
METHODS


Latinas with breast cancer and their supportive partners (SPs) were randomly assigned to one of two telephone delivered 8-week interventions: (i) telephone interpersonal counseling (TIP-C) or (ii) telephone health education (THE). QOL assessments were made at baseline, immediately after the 8-week interventions ended, and at an 8-week follow-up. Seventy Latinas and their 70 SPs completed all assessments (36 in health education and 34 in counseling) and were included in the final analysis.
RESULTS


Both Latinas with breast cancer and their SPs had significant improvements in virtually all dimensions of QOL over the 16 weeks of the investigation. However, there was no evidence documenting the superiority of either intervention for improving QOL. Preliminary cost analysis found that the counseling intervention cost about $164.68 for one dyad compared with $107.03 for health education. The majority of participants reported benefit from the intervention and liked that the intervention was in Spanish, included SPs, and was delivered by telephone.
CONCLUSION


The results of this study show that relatively brief, culturally appropriate, and highly accessible telephone-delivered interventions that provide emotional and information support can bring about substantial improvements in QOL for both Latinas with breast cancer and their SPs.",2013,Both Latinas with breast cancer and their SPs had significant improvements in virtually all dimensions of QOL over the 16 weeks of the investigation.,"['Latinas with breast cancer and their family members or friends (labeled supportive partners in this study', 'Latinas with breast cancer and their supportive partners (SPs', 'Seventy Latinas and their 70 SPs completed all assessments (36 in health education and 34 in counseling) and were included in the final analysis', 'Latinas with breast cancer and their supportive partners']","['telephone-delivered interventions', 'Telephone-delivered health education and interpersonal counseling', 'telephone delivered 8-week interventions: (i) telephone interpersonal counseling (TIP-C) or (ii) telephone health education (THE']","['quality of life (QOL) (psychological, physical, social, and spiritual', 'QOL', 'quality of life', 'QOL assessments']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4255078', 'cui_str': 'SPS'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3539085', 'cui_str': 'All'}, {'cui': 'C0018701'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0018701'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",70.0,0.0210837,Both Latinas with breast cancer and their SPs had significant improvements in virtually all dimensions of QOL over the 16 weeks of the investigation.,"[{'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Badger', 'Affiliation': 'College of Nursing, The University of Arizona, Tucson, AZ 85721-0203, USA. tbadger@nursing.arizona.edu'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Segrin', 'Affiliation': ''}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Hepworth', 'Affiliation': ''}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Pasvogel', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Weihs', 'Affiliation': ''}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Lopez', 'Affiliation': ''}]",Psycho-oncology,['10.1002/pon.3101']
704,32423392,Effect of feeding mode on infant growth and cognitive function: study protocol of the Chilean infant Nutrition randomized controlled Trial (ChiNuT).,"BACKGROUND


A central aim for pediatric nutrition is to develop infant formula compositionally closer to human milk. Milk fat globule membranes (MFGM) have shown to have functional components that are found in human milk, suggesting that addition of bovine sources of MFGM (bMFGM) to infant formula may promote beneficial outcomes potentially helping to narrow the gap between infants who receive human breast milk or infant formula. The objective of the current study is to determine how the addition of bMFGM in infant formula and consumption in early infancy affects physical growth and brain development when compared to infants fed with a standard formula and a reference group of infants fed with mother's own milk.
METHODS


Single center, double-blind, and parallel randomized controlled trial. Planned participant enrollment includes: infants exclusively receiving breast milk (n = 200; human milk reference group; HM) and infants whose mothers chose to initiate exclusive infant formula feeding before 4 months of age (n = 340). The latter were randomized to receive one of two study formulas until 12 months of age: 1) cow's milk based infant formula that had docosahexaenoic (DHA) (17 mg/100 kcal) and arachidonic acid (ARA) (25 mg/100 kcal); 1.9 g protein/100 kcal; 1.2 mg Fe/100 kcal (Standard formula; SF) or 2) a similar infant formula with an added source of bovine MFGM (whey protein-lipid concentrate (Experimental formula; EF). Primary outcomes will be: 1) Physical growth (Body weight, length, and head circumference) at 730 days of age; and 2) Cognitive development (Auditory Event-Related Potential) at 730 days of age. Data will be analyzed for all participants allocated to each study feeding group.
DISCUSSION


The results of this study will complement the knowledge regarding addition of bMFGM in infant formula including support of healthy growth and improvement of neurodevelopmental outcomes.
TRIAL REGISTRATION


NCT02626143, registered on December 10th 2015.",2020,The latter were randomized to receive one of two study formulas until 12 months of age: 1) cow's milk based infant formula that had docosahexaenoic (DHA) (17 mg/100 kcal) and arachidonic acid (ARA) (25 mg/100 kcal); 1.9 g protein/100 kcal; 1.2 mg Fe/100 kcal (Standard formula; SF) or 2) a similar infant formula with an added source of bovine MFGM (whey protein-lipid concentrate (Experimental formula; EF).,"[""infants fed with a standard formula and a reference group of infants fed with mother's own milk"", 'infants who receive human breast milk or infant formula']","['arachidonic acid (ARA) (25\u2009mg/100\u2009kcal); 1.9\u2009g protein/100\u2009kcal; 1.2\u2009mg Fe/100\u2009kcal (Standard formula; SF) or 2) a similar infant formula with an added source of bovine MFGM (whey protein-lipid concentrate (Experimental formula; EF', 'Planned participant enrollment includes: infants exclusively receiving breast milk (n\u2009=\u2009200; human milk reference group; HM', ""cow's milk based infant formula that had docosahexaenoic (DHA"", 'Milk fat globule membranes (MFGM', 'feeding mode', 'bMFGM']","['infant growth and cognitive function', '1) Physical growth (Body weight, length, and head circumference) at 730\u2009days of age; and 2) Cognitive development (Auditory Event-Related Potential']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C3853255', 'cui_str': 'Standard formula'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}]","[{'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C3853255', 'cui_str': 'Standard formula'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0670751', 'cui_str': 'milk fat globule'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0388561', 'cui_str': 'MFGE8 protein, human'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}]",,0.14066,The latter were randomized to receive one of two study formulas until 12 months of age: 1) cow's milk based infant formula that had docosahexaenoic (DHA) (17 mg/100 kcal) and arachidonic acid (ARA) (25 mg/100 kcal); 1.9 g protein/100 kcal; 1.2 mg Fe/100 kcal (Standard formula; SF) or 2) a similar infant formula with an added source of bovine MFGM (whey protein-lipid concentrate (Experimental formula; EF).,"[{'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Toro-Campos', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Av El Libano 5524, Macul, Santiago, Chile. rosario.toro@inta.uchile.cl.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Algarín', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Av El Libano 5524, Macul, Santiago, Chile.'}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Peirano', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Av El Libano 5524, Macul, Santiago, Chile.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Peña', 'Affiliation': 'Psychology Department, Pontific Catholic University, Santiago, Chile.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Murguia-Peniche', 'Affiliation': 'Medical Affairs, Mead Johnson Nutrition, Evansville, IN, USA.'}, {'ForeName': 'Steven S', 'Initials': 'SS', 'LastName': 'Wu', 'Affiliation': 'Medical Affairs, Mead Johnson Nutrition, Evansville, IN, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Uauy', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Av El Libano 5524, Macul, Santiago, Chile.'}]",BMC pediatrics,['10.1186/s12887-020-02087-9']
705,32423396,Effects of journal therapy counseling with anxious pregnant women on their infants' sleep quality: a randomized controlled clinical trial.,"BACKGROUND


Sleep is especially important for infants, since it stimulates the development of neural connections in their brains. Psychological stress such as anxiety could affect sleep quality. This study investigated the effects of journal therapy counseling sessions on the infants' sleep quality based on mothers' perception (primary outcome), maternal anxiety, infants' anthropometric and developmental parameters, and the frequency of exclusive breastfeeding (secondary outcomes).
METHODS


A total of 70 healthy women with gestational age of 28-31 weeks participated in this randomized controlled trial. The participants were randomly allocated into intervention and control groups using randomized block design. Three in-person journal therapy sessions and three telephone counseling sessions (2 between in-person sessions and 1 one month postpartum) were provided to those in the intervention group, while the control group only received routine care. The Infant Sleep Questionnaire (ISQ), Exclusive Breastfeeding Checklist, and Infant Anthropometric Parameters Checklist were completed at two and four months postpartum. The Beck Anxiety Inventory (BAI) was completed during pregnancy, at the end of the intervention, and at two and four months postpartum, and the Ages and Stages Questionnaire (ASQ) was completed at 4 months postpartum. Data were analyzed using chi-square, independent t-test, ANCOVA and repeated measure ANOVA.
RESULTS


There was no significant difference between the two groups in demographic characteristics and baseline anxiety scores. The mean sleep quality score in infants two months of age (MD: -4.2; 95%CI: - 1.1 to - 7.2; P = 0.007) and four months of age (MD: -5.5; 95%CI: - 8.4 to - 2.7; P < 0.001) was significantly lower in the intervention group than that of those in the control group. Based on the repeated measure ANOVA results, the mean postpartum anxiety score of mothers in the intervention group was significantly lower than that of those in the control group (AMD: -7.7; 95%CI: - 5.5 to - 10.1; P < 0.001). There was no significant difference between the two groups regarding other outcomes including the frequency of exclusive breastfeeding, and anthropometric and developmental parameters (P > 0.05).
CONCLUSION


Journal therapy can decrease mothers' anxiety and improve the infants' sleep quality based on their perception. However, further studies are required before drawing any definitive conclusion.
TRIAL REGISTRATION NUMBER


Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N45. Date of registration: August 11, 2018. URL: https://en.irct.ir/trial/33211.",2020,"There was no significant difference between the two groups regarding other outcomes including the frequency of exclusive breastfeeding, and anthropometric and developmental parameters (P > 0.05).
","['infants two months of age (MD', '70 healthy women with gestational age of 28-31\u2009weeks', ""anxious pregnant women on their infants' sleep quality""]","['journal therapy counseling sessions', 'telephone counseling sessions', 'control group only received routine care', 'journal therapy counseling']","['Beck Anxiety Inventory (BAI', 'mean postpartum anxiety score', 'demographic characteristics and baseline anxiety scores', ""mothers' anxiety"", 'mean sleep quality score', ""infants' sleep quality based on mothers' perception (primary outcome), maternal anxiety, infants' anthropometric and developmental parameters, and the frequency of exclusive breastfeeding (secondary outcomes"", 'frequency of exclusive breastfeeding, and anthropometric and developmental parameters', 'Infant Sleep Questionnaire (ISQ), Exclusive Breastfeeding Checklist, and Infant Anthropometric Parameters Checklist', 'sleep quality']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]","[{'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4761105', 'cui_str': 'Postpartum anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",70.0,0.0872959,"There was no significant difference between the two groups regarding other outcomes including the frequency of exclusive breastfeeding, and anthropometric and developmental parameters (P > 0.05).
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Montazeri', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mirghafourvand', 'Affiliation': 'Social Determinants of Health Research Centre, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. mirghafourvand@gmail.com.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Esmaeilpour', 'Affiliation': 'Faculty of Education and Psychology, University of Tabriz, Tabriz, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Mohammad-Alizadeh-Charandabi', 'Affiliation': 'Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Paria', 'Initials': 'P', 'LastName': 'Amiri', 'Affiliation': 'School of Nursing and Midwifery, Tabriz University of Medical Science, Tabriz, Iran.'}]",BMC pediatrics,['10.1186/s12887-020-02132-7']
706,32427795,Feasibility Study of the Health Empowerment Intervention in Older Adults With Heart Failure.,"BACKGROUND


Of almost 5.7 million Americans with heart failure, 80% are 65 years and older. Empowerment approaches facilitating recognition of personal and social contextual resources may improve well-being in this vulnerable population.
OBJECTIVE


This research evaluated the feasibility of the Health Empowerment Intervention (HEI) in older adults with heart failure, including effects on health empowerment, purposeful participation, self-management, functional health, and well-being.
METHODS


Twenty older adults with heart failure were randomly assigned to HEI or Attention Control conditions. The HEI consisted of 6 weekly sessions based on the Health Empowerment Theory. Outcomes were measured at baseline and at 6 weeks.
RESULTS


Feasibility of the HEI was supported; participants realized significant improvement in health empowerment and purposeful participation in goal attainment.ConclusionsThis research supports the feasibility of the HEI and provides a basis for continued evaluation.",2020,"RESULTS


Feasibility of the HEI was supported; participants realized significant improvement in health empowerment and purposeful participation in goal attainment.
","['5.7 million Americans with heart failure', 'older adults with heart failure', 'Older Adults With Heart Failure', 'Twenty older adults with heart failure']","['HEI or Attention Control conditions', 'Health Empowerment Intervention (HEI', 'Health Empowerment Intervention']",['health empowerment and purposeful participation in goal attainment'],"[{'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",20.0,0.0373831,"RESULTS


Feasibility of the HEI was supported; participants realized significant improvement in health empowerment and purposeful participation in goal attainment.
","[{'ForeName': 'Ramesh Devi', 'Initials': 'RD', 'LastName': 'Thakur', 'Affiliation': ""Ramesh Devi Thakur, PhD, MSN, RN Assistant Professor, Mount Saint Mary's University, Los Angeles, California. Julie D. Fleury, PhD, RN, FAAN Professor, College of Nursing & Health Innovation, Arizona State University, Health North, Phoenix, Arizona. Nelma B. Crawford Shearer, PhD, RN, FAAN Associate Professor Emeritus, College of Nursing & Health Innovation, Arizona State University, Health North, Phoenix, Arizona. Michael Belyea, PhD Research Professor, College of Nursing & Health Innovation, Arizona State University.""}, {'ForeName': 'Julie D', 'Initials': 'JD', 'LastName': 'Fleury', 'Affiliation': ''}, {'ForeName': 'Nelma B', 'Initials': 'NB', 'LastName': 'Crawford Shearer', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Belyea', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000673']
707,21153533,"The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study: recruitment, intervention and follow-up.","AIMS/HYPOTHESIS


The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study was designed to establish whether weaning to a highly hydrolysed formula in infancy subsequently reduces the risk of type 1 diabetes.
METHODS


The study population comprises newborn infants who have first-degree relatives with type 1 diabetes and meet the increased risk HLA inclusion, but not exclusion criteria. The study is being performed in 15 countries in three continents. First-degree relatives of patients with type 1 diabetes were identified from diabetes clinics, diabetes registries, and from other endocrinology or obstetrics offices and websites. HLA typing was performed at birth from cord or heel stick blood, and the results sent to the study's Data Management Unit within 2 weeks for communication of eligibility to the clinical study centre. All mothers recruited were encouraged to breastfeed. The intervention lasted for 6 to 8 months, and weaning formulas based on hydrolysed casein and standard cow's milk were compared.
RESULTS


TRIGR recruited 5,606 infants, of whom 2,160 were enrolled as eligible participants, 6% more than the target of 2,032. Of those enrolled, 80% were exposed to the study formula. The overall retention rate over the first 5 years is 87%, with protocol compliance at 94%. The randomisation code will be opened when the last recruited child turns 10 years of age, i.e. in 2017.
CONCLUSIONS/INTERPRETATION


The TRIGR experience demonstrates the feasibility and successful implementation of an international dietary intervention study. TRIGR is the first ever primary prevention trial for type 1 diabetes and, if completed successfully, will provide a definite answer to the research question.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00179777
FUNDING


The study was funded by the National Institute of Child Health and Development (NICHD) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH) (grant numbers HD040364, HD042444 and HD051997), Canadian Institutes of Health Research, the Juvenile Diabetes Research Foundation International and the Commission of the European Communities (specific RTD programme 'Quality of Life and Management of Living Resources', contract number QLK1-2002-00372 'Diabetes Prevention'. Other funding came from the EFSD/JDRF/Novo Nordisk Focused Research Grant, Academy of Finland, Dutch Diabetes Research Foundation and Finnish Diabetes Research Foundation).",2011,"The overall retention rate over the first 5 years is 87%, with protocol compliance at 94%.","['TRIGR recruited 5,606 infants, of whom 2,160 were enrolled as eligible participants, 6% more than the target of 2,032', 'All mothers recruited were encouraged to breastfeed', '15 countries in three continents', 'newborn infants who have first-degree relatives with type 1 diabetes and meet the increased risk HLA inclusion, but not exclusion criteria']",[],['overall retention rate'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0443192', 'cui_str': 'Continent (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",5606.0,0.0286784,"The overall retention rate over the first 5 years is 87%, with protocol compliance at 94%.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Hospital for Children and Adolescents, University of Helsinki, Biomedicum Helsinki 2 U, PO Box\xa020, 00014, Helsinki, Finland.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Akerblom', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Krischer', 'Affiliation': ''}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Virtanen', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Berseth', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Becker', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dupré', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ilonen', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Trucco', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Savilahti', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Koski', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pajakkala', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fransiscus', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Lough', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bradley', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Koski', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Knip', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-010-1964-9']
708,32430272,Diagnostic efficacy of three suction techniques for endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic lesions: protocol for a multicenter randomized cross-over clinical trial.,"BACKGROUND


How suction technique affects endoscopic ultrasound-guided tissue acquisition (EUS-TA) remains unclear. A standardized protocol is currently lacking, with most previous studies being restricted to EUS-guided fine-needle aspiration (EUS-FNA). The research related to EUS-guided fine-needle biopsy (EUS-FNB) is sparse.
AIMS


The aim of this study is to evaluate the diagnostic efficacy, cellularity, tissue acquisition, blood contamination and adverse event rate of three common suction techniques (standard suction, slow-pull, and wet suction) used for EUS-FNB of solid pancreatic masses.
METHODS


This is a multicenter single-blind randomized cross-over superiority trial. A total of 300 patients with suspected pancreatic malignancy will be enrolled from digestive endoscopic centers at five large tertiary hospitals in China. All three suction techniques will be performed on each patient using a 25G ProCore needle, with the sequence of suction techniques determined by randomization. Cytological and histological specimens obtained with each of the three techniques will be assessed independently. Outcomes among the three suction techniques will be compared.
DISCUSSION


To the best of our knowledge, this is the largest multicenter randomized cross-over trial designed to determine the optimal suction technique for the diagnosis of solid pancreatic masses. This study may contribute to standardizing the suction technique for EUS-FNB.",2020,"All three suction techniques will be performed on each patient using a 25G ProCore needle, with the sequence of suction techniques determined by randomization.",['300 patients with suspected pancreatic malignancy will be enrolled from digestive endoscopic centers at five large tertiary hospitals in China'],"['endoscopic ultrasound-guided fine-needle biopsy', 'three common suction techniques (standard suction, slow-pull, and wet suction']","['diagnostic efficacy, cellularity, tissue acquisition, blood contamination and adverse event rate', 'Diagnostic efficacy']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0205381', 'cui_str': 'Wet'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",300.0,0.0776443,"All three suction techniques will be performed on each patient using a 25G ProCore needle, with the sequence of suction techniques determined by randomization.","[{'ForeName': 'Shi-Yu', 'Initials': 'SY', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Gastroenterology, Affiliated Hospital of Southwest Medical University, Southwest Medical University, Luzhou, Sichuan Province, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': 'Department of Gastroenterology, Wuhan Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei Province, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital, Second Clinical Medical Sciences of Jinan University, Shenzhen, Guangdong Province, China.""}, {'ForeName': 'Yue-Ping', 'Initials': 'YP', 'LastName': 'Jiang', 'Affiliation': 'Department of Gastroenterology, Affiliated Hospital of Qingdao University, Medical College of Qingdao University, Qingdao, Shandong Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Pathology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Pathology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China.'}, {'ForeName': 'Zhen-Dong', 'Initials': 'ZD', 'LastName': 'Jin', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China. Electronic address: zhendjin@126.com.'}, {'ForeName': 'Kai-Xuan', 'Initials': 'KX', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China. Electronic address: wangkaixuan224007@163.com.'}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2020.03.026']
709,19138933,Aberrant crypt foci in the adenoma prevention with celecoxib trial.,"Aberrant crypt foci (ACF) are the earliest visible neoplastic lesions in the colorectum. The natural history of these lesions and their role in the adenoma-carcinoma sequence are unknown. We studied ACF in a subset of patients randomized to placebo (n = 17), celecoxib (200 mg twice daily; n = 15), or celecoxib (400 mg twice daily; n = 13) in the Adenoma Prevention with Celecoxib (APC) trial. Magnification chromoendoscopy was done to identify, count, and biopsy ACF within the rectum at baseline and after 8 to 12 months of treatment. A total of 655 ACF were identified in 45 patients. We examined 70 of these ACF histologically, and all 70 were nondysplastic. Cohort characteristics and APC trial treatment results for substudy patients were similar to those of the overall APC trial. There was no significant modulation of ACF by celecoxib (versus placebo; P = 0.77). Immunohistochemical comparison of ACF with adjacent normal mucosa showed that ACF had an increased proliferative index as determined by Ki-67 (P < 0.0001), but lacked other features of neoplasia such as increased cyclooxygenase-2 expression and microvessel density, nuclear localization of beta-catenin, or decreased expression of the tumor suppressors SMAD4, Estrogen Receptor alpha, or MGMT. Only baseline SMAD4 expression in ACF correlated with posttreatment adenoma recurrence (independent of treatment arm; P = 0.01). The presence or number of nondysplastic ACF did not correlate with a higher risk of synchronous advanced or recurrent adenomas. Our overall results indicated that nondysplastic ACF were not accurate surrogate endpoint biomarkers of recurrent colorectal adenomas in the APC trial.",2008,The presence or number of nondysplastic ACF did not correlate with a higher risk of synchronous advanced or recurrent adenomas.,[],"['Celecoxib', 'placebo', 'celecoxib ', 'ACF', 'nondysplastic ACF', 'celecoxib']","['proliferative index', 'ACF', 'Aberrant crypt foci', 'cyclooxygenase-2 expression and microvessel density, nuclear localization of beta-catenin, or decreased expression of the tumor suppressors SMAD4, Estrogen Receptor alpha, or MGMT', 'Aberrant crypt foci (ACF']",[],"[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1171800', 'cui_str': '(18F)ACF'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1171800', 'cui_str': '(18F)ACF'}, {'cui': 'C1879526', 'cui_str': 'Aberrant Crypt Foci'}, {'cui': 'C0387583', 'cui_str': 'COX-2 Prostaglandin Synthase'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C2350570', 'cui_str': 'Microvessels'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0475264', 'cui_str': 'Localization - action (qualifier value)'}, {'cui': 'C0105770'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0665341', 'cui_str': 'Estrogen Receptor alpha'}]",655.0,0.177643,The presence or number of nondysplastic ACF did not correlate with a higher risk of synchronous advanced or recurrent adenomas.,"[{'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Cho', 'Affiliation': ""Department of Surgery, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Redston', 'Affiliation': ''}, {'ForeName': 'Ann G', 'Initials': 'AG', 'LastName': 'Zauber', 'Affiliation': ''}, {'ForeName': 'Adelaide M', 'Initials': 'AM', 'LastName': 'Carothers', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Hornick', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wilton', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sontag', 'Affiliation': ''}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Nishioka', 'Affiliation': ''}, {'ForeName': 'Francis M', 'Initials': 'FM', 'LastName': 'Giardiello', 'Affiliation': ''}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Saltzman', 'Affiliation': ''}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gostout', 'Affiliation': ''}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Eagle', 'Affiliation': ''}, {'ForeName': 'Ernest T', 'Initials': 'ET', 'LastName': 'Hawk', 'Affiliation': ''}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Bertagnolli', 'Affiliation': ''}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-07-0011']
710,31654434,In response to Dexmedetomidine versus propofol at different sedation depths during drug-induced sleep endoscopy: A randomized trial.,,2020,,[],"['propofol', 'Dexmedetomidine']",[],[],"[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]",[],,0.0283193,,"[{'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Tonsy', 'Initials': 'T', 'LastName': 'Pandiyara', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Gandhi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Bansal', 'Affiliation': 'Department of Otolaryngology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}]",The Laryngoscope,['10.1002/lary.28363']
711,20474068,Breastfeeding patterns of mothers with type 1 diabetes: results from an infant feeding trial.,"BACKGROUND


Both the initiation and maintenance of breastfeeding have been reported to be negatively affected by maternal type 1 diabetes (T1D). The aim of this study was to prospectively examine the breastfeeding patterns among mothers with and without T1D participating in a large international randomized infant feeding trial (TRIGR).
METHODS


Families with a member affected by T1D and with a newborn infant were invited into the study. Those who had HLA-conferred genetic susceptibility for T1D tested at birth with gestation > 35 weeks and were healthy were eligible to continue in the trial. Among the 2160 participating children, 1096 were born to women with T1D and 1064 to unaffected women. Information on infant feeding was acquired from the family by frequent prospective dietary interviews.
RESULTS


Most (>90%) of the infants of mothers with and without T1D were initially breastfed. Breastfeeding rates declined more steeply among mothers with than without T1D being 50 and 72% at 6 months, respectively. Mothers with T1D were younger, less educated and delivered earlier and more often by caesarean section than other mothers (p < 0.01). After adjusting for all these factors associated with the termination of breastfeeding, there was no difference in the duration of breastfeeding among mothers with and without T1D.
CONCLUSIONS


Maternal diabetes status per se was not associated with shorter breastfeeding. The lower duration of breastfeeding in mothers with T1D is largely explained by their more frequent caesarean sections, earlier delivery and lower age and education.",2010,"Mothers with T1D were younger, less educated and delivered earlier and more often by caesarean section than other mothers (p < 0.01).","['Those who had HLA-conferred genetic susceptibility for T1D tested at birth with gestation > 35 weeks and were healthy were eligible to continue in the trial', 'mothers with and without T1D participating in a large international randomized infant feeding trial (TRIGR', 'mothers with type 1 diabetes', '2160 participating children, 1096 were born to women with T1D and 1064 to unaffected women', 'Families with a member affected by T1D and with a newborn infant were invited into the study']",[],"['lower duration of breastfeeding', 'duration of breastfeeding', 'Breastfeeding rates']","[{'cui': 'C0314657', 'cui_str': 'Genetic Susceptibility'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}]",2160.0,0.0619341,"Mothers with T1D were younger, less educated and delivered earlier and more often by caesarean section than other mothers (p < 0.01).","[{'ForeName': 'Susa', 'Initials': 'S', 'LastName': 'Sorkio', 'Affiliation': 'Nutrition Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cuthbertson', 'Affiliation': ''}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Bärlund', 'Affiliation': ''}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Reunanen', 'Affiliation': ''}, {'ForeName': 'Anita M', 'Initials': 'AM', 'LastName': 'Nucci', 'Affiliation': ''}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Berseth', 'Affiliation': ''}, {'ForeName': 'Katriina', 'Initials': 'K', 'LastName': 'Koski', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ormisson', 'Affiliation': ''}, {'ForeName': 'Erkki', 'Initials': 'E', 'LastName': 'Savilahti', 'Affiliation': ''}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Uusitalo', 'Affiliation': ''}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Ludvigsson', 'Affiliation': ''}, {'ForeName': 'Dorothy J', 'Initials': 'DJ', 'LastName': 'Becker', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Dupré', 'Affiliation': ''}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Krischer', 'Affiliation': ''}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Knip', 'Affiliation': ''}, {'ForeName': 'Hans K', 'Initials': 'HK', 'LastName': 'Akerblom', 'Affiliation': ''}, {'ForeName': 'Suvi M', 'Initials': 'SM', 'LastName': 'Virtanen', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.1074']
712,32128615,"Randomized, double-blind, placebo-controlled study of aprepitant versus two dosages of olanzapine with ondansetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving high-emetogenic chemotherapy.","PURPOSE


We assessed the efficacy of aprepitant (APR) or 10 or 5 mg OLN (OLN10 or OLN5) plus ondansetron and dexamethasone for chemotherapy-induced nausea/vomiting (CINV) prophylaxis in patients receiving high-emetogenic chemotherapy (HEC).
METHODS


Patients who received doxorubicin + cyclophosphamide or cisplatin were given intravenous ondansetron and dexamethasone prior to chemotherapy and oral dexamethasone on days 2-4 and randomized 1:1:1 to receive APR125 on day 1 and APR80 on days 2-3 or OLN10 or OLN5 on days 1-4. Matched placebo controls were used. The primary endpoint was no nausea in ≤ 120 h. Secondary endpoints included CINV severity, complete response (CR) rate, adverse effects (AE), and quality of life.
RESULTS


Of 141 patients, 104 received AC and 37 received cisplatin. The no-nausea rates were 33% (APR), 43.2% (OLN10; p = 0.24), and 37% (OLN5; p = 0.87). Grades 2-4 nausea were experienced by fewer patients for OLN10 than for APR (24-120 h, 8.7% vs. 27.7%, respectively; p = 0.02; overall period, 19.6% vs. 40.4%, respectively; p = 0.03). The median visual analog scale nausea score from 24 to 120 h was significantly lower for OLN10 (2.3) than for APR (1.2, p = 0.03). The degrees of vomiting, CR, and AE were similar between the APR and OLN10 groups. CINV was similar between the OLN5 and APR groups.
CONCLUSIONS


Nausea was less severe for OLN10 than for APR in patients receiving HEC, but other measures were similar. CINV prevention efficacy was comparable between OLN5 and APR.",2020,"The median visual analog scale nausea score from 24 to 120 h was significantly lower for OLN10 (2.3) than for APR (1.2, p = 0.03).","['Of 141 patients, 104 received AC and 37 received', 'patients receiving high-emetogenic chemotherapy (HEC', 'Patients who received', 'patients receiving high-emetogenic chemotherapy']","['ondansetron and dexamethasone prior to chemotherapy and oral dexamethasone', 'placebo', 'cisplatin', 'olanzapine with ondansetron plus dexamethasone', 'aprepitant (APR) or 10 or 5\xa0mg OLN (OLN10 or OLN5) plus ondansetron and dexamethasone', 'APR125', 'OLN10 or OLN5', 'doxorubicin + cyclophosphamide or cisplatin']","['nausea and vomiting', 'median visual analog scale nausea score', 'CINV', 'degrees of vomiting, CR, and AE', 'CINV severity, complete response (CR) rate, adverse effects (AE), and quality of life', 'Grades 2-4 nausea', 'no-nausea rates', 'nausea/vomiting (CINV) prophylaxis', 'nausea', 'CINV prevention efficacy']","[{'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0318598', 'cui_str': 'Human enteric calicivirus (organism)'}]","[{'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0034380'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0423584', 'cui_str': 'No nausea'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]",141.0,0.4139,"The median visual analog scale nausea score from 24 to 120 h was significantly lower for OLN10 (2.3) than for APR (1.2, p = 0.03).","[{'ForeName': 'Suthinee', 'Initials': 'S', 'LastName': 'Ithimakin', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand. aesi105@yahoo.co.th.'}, {'ForeName': 'Pathra', 'Initials': 'P', 'LastName': 'Theeratrakul', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand.'}, {'ForeName': 'Apirom', 'Initials': 'A', 'LastName': 'Laocharoenkiat', 'Affiliation': 'Pharmacy Department, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Akarin', 'Initials': 'A', 'LastName': 'Nimmannit', 'Affiliation': 'Department of Research, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Charuwan', 'Initials': 'C', 'LastName': 'Akewanlop', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand.'}, {'ForeName': 'Nopadol', 'Initials': 'N', 'LastName': 'Soparattanapaisarn', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand.'}, {'ForeName': 'Sirisopa', 'Initials': 'S', 'LastName': 'Techawattanawanna', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand.'}, {'ForeName': 'Krittiya', 'Initials': 'K', 'LastName': 'Korphaisarn', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand.'}, {'ForeName': 'Pongwut', 'Initials': 'P', 'LastName': 'Danchaivijitr', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05380-6']
713,32330613,Comparison of Radiation Exposure Among 3 Different Endoscopic Diskectomy Techniques for Lumbar Disk Herniation.,"BACKGROUND


Lumbar disk herniation can be successfully treated by lumbar endoscopic spinal procedures. However, one of the most important disadvantages of the endoscopic methods used is radiation exposure. There are multiple endoscopic spinal procedures and this study aims to compare unilateral biportal endoscopic diskectomy (UBED), percutaneous endoscopic lumbar diskectomy (PELD), and microendoscopic diskectomy (MED) methods in terms of radiation exposure.
METHODS


A total of 75 people were included in this prospective and multicenter study. The demographic characteristics, operating times (minutes), levels of surgery, lumbar disk herniation types, radiation exposures (dose area product [DAP]), and fluoroscopy times (seconds) of the groups were compared.
RESULTS


Mean DAP values were 1.39 Gy·cm 2  in the UBED group, 2.46 Gy·cm 2  in the PELD group, and 1.01 Gy·cm 2  in the MED group. The UBED group had no statistically significant difference with the MED and PELD groups in terms of DAP (P = 0.281 and P = 0.058, respectively), whereas the PELD group had statistically significantly higher DAP values than the MED group (P = 0.016). The maximum mean duration of fluoroscopy usage time was 34.9 seconds in the PELD group, 19.3 seconds in the UBED group, and 4.6 seconds in the MED group. The differences between the groups were significant (P ≤ 0.001).
CONCLUSIONS


The more the level of invasiveness is reduced in spinal surgery, the greater the exposure to radiation. In this study, the groups are listed as PELD > UBED > MED according to the duration and level of radiation exposure.",2020,"Mean DAP values were 1.39 Gy·cm 2  in the UBED group, 2.46 Gy·cm 2  in the PELD group, and 1.01 Gy·cm 2  in the MED group.","['Lumbar Disk Herniation', 'A total of 75 people']","['unilateral biportal endoscopic diskectomy (UBED), percutaneous endoscopic lumbar diskectomy (PELD), and microendoscopic diskectomy (MED']","['maximum mean duration of fluoroscopy usage time', 'level of invasiveness', 'Mean DAP values', 'demographic characteristics, operating times (minutes), levels of surgery, lumbar disk herniation types, radiation exposures (dose area product [DAP]), and fluoroscopy times (seconds', 'DAP values']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301757', 'cui_str': 'Invasiveness'}, {'cui': 'C0045587', 'cui_str': '2,6-diaminopurine'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Studies'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",75.0,0.0289979,"Mean DAP values were 1.39 Gy·cm 2  in the UBED group, 2.46 Gy·cm 2  in the PELD group, and 1.01 Gy·cm 2  in the MED group.","[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Merter', 'Affiliation': 'Department of Orthopedics, Spine Section, School of Medicine, Ibn-i Sina Hospital, Ankara University, Ankara, Turkey. Electronic address: dr.merter@gmail.com.'}, {'ForeName': 'Oguz', 'Initials': 'O', 'LastName': 'Karaeminogullari', 'Affiliation': 'Department of Orthopedics, Spine Section, Bayindir Sogutozu Hospital, Ankara, Turkey.'}, {'ForeName': 'Motohide', 'Initials': 'M', 'LastName': 'Shibayama', 'Affiliation': 'Department of Orthopedics, Spine Section, Aichi Spine Hospital, Aichi Prefecture, Japan.'}]",World neurosurgery,['10.1016/j.wneu.2020.04.079']
714,28169875,Vitamin A and D Deficiencies Associated With Incident Tuberculosis in HIV-Infected Patients Initiating Antiretroviral Therapy in Multinational Case-Cohort Study.,"INTRODUCTION


Numerous micronutrients have immunomodulatory roles that may influence risk of tuberculosis (TB), but the association between baseline micronutrient deficiencies and incident TB after antiretroviral therapy (ART) initiation in HIV-infected individuals is not well characterized.
METHODS


We conducted a case-cohort study (n = 332) within a randomized trial comparing 3 ART regimens in 1571 HIV treatment-naive adults from 9 countries. A subcohort of 30 patients was randomly selected from each country (n = 270). Cases (n = 77; main cohort = 62, random subcohort = 15) included patients diagnosed with TB by 96 weeks post-ART initiation. We determined pretreatment concentrations of vitamin A, carotenoids, vitamin B6, vitamin B12, vitamin D, vitamin E, and selenium. We measured associations between pretreatment micronutrient deficiencies and incident TB using Breslow-weighted Cox regression models.
RESULTS


Median pretreatment CD4 T-cell count was 170 cells/mm; 47.3% were women; and 53.6% Black. In multivariable models after adjusting for age, sex, country, treatment arm, previous TB, baseline CD4 count, HIV viral load, body mass index, and C-reactive protein, pretreatment deficiency in vitamin A (adjusted hazard ratio, aHR 5.33, 95% confidence interval, CI: 1.54 to 18.43) and vitamin D (aHR 3.66, 95% CI: 1.16 to 11.51) were associated with TB post-ART.
CONCLUSIONS


In a diverse cohort of HIV-infected adults from predominantly low- and middle-income countries, deficiencies in vitamin A and vitamin D at ART initiation were independently associated with increased risk of incident TB in the ensuing 96 weeks. Vitamin A and D may be important modifiable risk factors for TB in high-risk HIV-infected patients starting ART in resource-limited highly-TB-endemic settings.",2017,"RESULTS


Median pretreatment CD4 T-cell count was 170 cells/mm; 47.3% were women; and 53.6% Black.","['30 patients was randomly selected from each country (n = 270', 'HIV-Infected Patients', '1571 HIV treatment-naive adults from 9 countries']","['Vitamin A and D Deficiencies', 'Vitamin A and D', 'vitamin A, carotenoids, vitamin B6, vitamin B12, vitamin D, vitamin E, and selenium']","['previous TB, baseline CD4 count, HIV viral load, body mass index, and C-reactive protein, pretreatment deficiency in vitamin A', 'Median pretreatment CD4 T-cell count']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0087162', 'cui_str': 'Vitamin B6'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}]","[{'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",1571.0,0.696354,"RESULTS


Median pretreatment CD4 T-cell count was 170 cells/mm; 47.3% were women; and 53.6% Black.","[{'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Tenforde', 'Affiliation': '*Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington School of Medicine, Seattle, WA; Departments of †International Health; ‡Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; §Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD; ‖Department of Medicine, Bridgeport Hospital, Yale New Haven Health, Bridgeport, CT; ¶Department of Medicine, University of Witwatersrand, Johannesburg, South Africa; #UNC Lilongwe, Lilongwe, Malawi; **Durban International Clinical Research Site, Durban University of Technology, Durban, South Africa; ††University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe; ‡‡Hospital Nossa Senhora de Conceição, Porto Alegre, Brazil; §§YR Gaitonde Centre for AIDS Research and Education, Chennai, India; ‖‖National AIDS Research Institute, Pune, India; ¶¶Les Centres GHESKIO, Port-Au-Prince, Haiti; ##Malawi College of Medicine, Johns Hopkins University Research Project, Blantyre, Malawi; ***Liverpool School of Tropical Medicine, Liverpool, United Kingdom; †††Asociacion Civil Impacta Salud y Educacion, Lima, Peru; ‡‡‡STD/AIDS Clinical Research Laboratory, Instituto de Pesquisa Clinica Evandro Chagas, Fundacao Oswaldo Cruz, Rio de Janeiro, Brazil; §§§Research Institute for Health Sciences, Chiang Mai, Thailand; ‖‖‖Department of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, MD; and ¶¶¶Division of Infectious Diseases, Department of Medicine, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Yadav', 'Affiliation': ''}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': ''}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Gupte', 'Affiliation': ''}, {'ForeName': 'Rupak', 'Initials': 'R', 'LastName': 'Shivakoti', 'Affiliation': ''}, {'ForeName': 'Wei-Teng', 'Initials': 'WT', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Noluthando', 'Initials': 'N', 'LastName': 'Mwelase', 'Affiliation': ''}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Kanyama', 'Affiliation': ''}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Pillay', 'Affiliation': ''}, {'ForeName': 'Wadzanai', 'Initials': 'W', 'LastName': 'Samaneka', 'Affiliation': ''}, {'ForeName': 'Breno', 'Initials': 'B', 'LastName': 'Santos', 'Affiliation': ''}, {'ForeName': 'Selvamuthu', 'Initials': 'S', 'LastName': 'Poongulali', 'Affiliation': ''}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Tripathy', 'Affiliation': ''}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Riviere', 'Affiliation': ''}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Berendes', 'Affiliation': ''}, {'ForeName': 'Javier R', 'Initials': 'JR', 'LastName': 'Lama', 'Affiliation': ''}, {'ForeName': 'Sandra W', 'Initials': 'SW', 'LastName': 'Cardoso', 'Affiliation': ''}, {'ForeName': 'Patcharaphan', 'Initials': 'P', 'LastName': 'Sugandhavesa', 'Affiliation': ''}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Christian', 'Affiliation': ''}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Semba', 'Affiliation': ''}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000001308']
715,31529471,Comparing the efficacy of field treatments for actinic keratosis: a critical appraisal of a randomized trial in the New England Journal of Medicine.,"AIM


Jansen et al. conducted a randomized trial to compare the efficacy of four field treatments for actinic keratosis (AK).
SETTING AND DESIGN


This was a multicentre, single-blind, randomized trial conducted in the dermatology departments of four Netherlands hospitals. Patients were not blinded. The investigator who evaluated the trial outcome was blinded.
STUDY EXPOSURE


This study included adult patients with at least five AKs on the face or vertex scalp. Patients were randomized to treatment with fluorouracil 5% cream, imiquimod 5% cream, methyl aminolaevulinate photodynamic therapy (MAL-PDT) or ingenol mebutate 0·015% gel.
OUTCOMES


The primary outcome was whether patients had ≥ 75% reduction in AK count 12 months after treatment.
RESULTS


In total 624 patients participated. The likelihood of having ≥ 75% reduction in AK count 12 months after treatment was significantly higher (twice as high or greater) for fluorouracil than for any other therapy. Approximately 75% of patients treated with fluorouracil experienced ≥ 75% reduction in AK count at 12 months.
CONCLUSIONS


Jansen et al. conclude that 1 year after treatment, fluorouracil was significantly more effective at AK reduction than imiquimod, MAL-PDT or ingenol mebutate.",2020,The likelihood of having at least a 75% reduction in AK count 12 months after treatment was significantly higher (twice as high or greater) for fluorouracil than for any other therapy.,"['624 patients participated', 'actinic keratosis (AK', 'dermatology departments of four Netherlands hospitals', 'adult patients with at least five AKs on the face or vertex scalp', 'actinic keratosis']","['5% fluorouracil cream, 5% imiquimod cream, methyl aminolevulinate photodynamic therapy (MAL-PDT), or 0.015% ingenol mebutate gel', 'fluorouracil']",['AK count'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022602', 'cui_str': 'Senile keratoma (disorder)'}, {'cui': 'C0587461', 'cui_str': 'Dermatology department (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0230003', 'cui_str': 'Vertex structure'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}, {'cui': 'C1134467', 'cui_str': 'methyl aminolevulinate'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C4517396', 'cui_str': 'Zero point zero one five'}, {'cui': 'C2825682', 'cui_str': 'ingenol mebutate'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",624.0,0.167952,The likelihood of having at least a 75% reduction in AK count 12 months after treatment was significantly higher (twice as high or greater) for fluorouracil than for any other therapy.,"[{'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Wehner', 'Affiliation': 'Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, 19104, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.18537']
716,30642386,Correction to: AMBIsome Therapy Induction OptimisatioN (AMBITION): High Dose AmBisome for Cryptococcal Meningitis Induction Therapy in sub-Saharan Africa: Study Protocol for a Phase 3 Randomised Controlled Non-Inferiority Trial.,"Following publication of the original article [1], we have been notified that one of the author names was listed incorrectly. Both incorrect and correct author names are presented below. The original publication has been corrected.",2019,"Following publication of the original article [1], we have been notified that one of the author names was listed incorrectly.",[],['AMBIsome Therapy'],[],[],"[{'cui': 'C0591076', 'cui_str': 'AmBisome'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0494773,"Following publication of the original article [1], we have been notified that one of the author names was listed incorrectly.","[{'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Lawrence', 'Affiliation': 'Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK. david.s.lawrence@lshtm.ac.uk.'}, {'ForeName': 'Nabila', 'Initials': 'N', 'LastName': 'Youssouf', 'Affiliation': 'Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Síle F', 'Initials': 'SF', 'LastName': 'Molloy', 'Affiliation': ""Research Centre for Infection and Immunity, St George's University of London, London, UK.""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Alanio', 'Affiliation': 'Molecular Mycology Unit and National Reference Centre for Invasive Mycoses, Institut Pasteur, Paris, France.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Alufandika', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Timothée', 'Initials': 'T', 'LastName': 'Boyer-Chammard', 'Affiliation': 'Molecular Mycology Unit and National Reference Centre for Invasive Mycoses, Institut Pasteur, Paris, France.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Sciences and International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Francoise', 'Initials': 'F', 'LastName': 'Dromer', 'Affiliation': 'Molecular Mycology Unit and National Reference Centre for Invasive Mycoses, Institut Pasteur, Paris, France.'}, {'ForeName': 'Admire', 'Initials': 'A', 'LastName': 'Hlupeni', 'Affiliation': 'Department of Medicine, University of Zimbabwe College of Health Sciences, Parirenyatwa Hospital, Harare, Zimbabwe.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hope', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'Lilongwe Medical Relief Trust (UNC Project), Lilongwe, Malawi.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Kanyama', 'Affiliation': 'Lilongwe Medical Relief Trust (UNC Project), Lilongwe, Malawi.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Lortholary', 'Affiliation': 'Molecular Mycology Unit and National Reference Centre for Invasive Mycoses, Institut Pasteur, Paris, France.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Loyse', 'Affiliation': ""Research Centre for Infection and Immunity, St George's University of London, London, UK.""}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Meya', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Mosepele', 'Initials': 'M', 'LastName': 'Mosepele', 'Affiliation': 'Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Muzoora', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Henry C', 'Initials': 'HC', 'LastName': 'Mwandumba', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Chiratidzo E', 'Initials': 'CE', 'LastName': 'Ndhlovu', 'Affiliation': 'Department of Medicine, University of Zimbabwe College of Health Sciences, Parirenyatwa Hospital, Harare, Zimbabwe.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Niessen', 'Affiliation': 'Department of Clinical Sciences and International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Schutz', 'Affiliation': 'Wellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, and Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Katharine E', 'Initials': 'KE', 'LastName': 'Stott', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Sciences and International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Lalloo', 'Affiliation': 'Department of Clinical Sciences and International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Meintjes', 'Affiliation': 'Wellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, and Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Shabbar', 'Initials': 'S', 'LastName': 'Jaffar', 'Affiliation': 'Department of Clinical Sciences and International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Harrison', 'Affiliation': ""Research Centre for Infection and Immunity, St George's University of London, London, UK.""}, {'ForeName': 'Joseph N', 'Initials': 'JN', 'LastName': 'Jarvis', 'Affiliation': 'Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.'}]",Trials,['10.1186/s13063-018-3155-9']
717,31668477,Dopaminergic D 1  Receptor Stimulation Affects Effort and Risk Preferences.,"BACKGROUND


Activation of D 1  receptors has been related to successful goal-directed behavior, but it remains unclear whether D 1  receptor activation causally tips the balance of weighing costs and benefits in humans. Here, we tested the impact of pharmacologically stimulated D 1  receptors on sensitivity to risk, delay, and effort costs in economic choice and investigated whether D 1  receptor stimulation would bias preferences toward options with increased costs in a cost-specific manner.
METHODS


In a randomized, double-blind, placebo-controlled, parallel-group phase 1 study, 120 healthy young volunteers received either placebo or 1 of 3 doses (6 mg, 15 mg, or 30 mg) of a novel, selective D 1  agonist (PF-06412562). After drug administration, participants performed decision tasks measuring their preferences for risky, delayed, and effortful outcomes.
RESULTS


Higher doses of the D 1  agonist increased the willingness to exert physical effort for reward as well as reduced the preference for risky outcomes. We observed no effects on preferences for delayed rewards.
CONCLUSIONS


The current results provide evidence that D 1  receptor stimulation causally affects core aspects of cost-benefit decision making in humans.",2020,"RESULTS


Higher doses of the D 1  agonist increased the willingness to exert physical effort for reward as well as reduced the preference for risky outcomes.",['120 healthy young volunteers'],"['placebo', 'novel, selective D 1  agonist (PF-06412562']",[],"[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]",[],120.0,0.320326,"RESULTS


Higher doses of the D 1  agonist increased the willingness to exert physical effort for reward as well as reduced the preference for risky outcomes.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Soutschek', 'Affiliation': 'Zurich Center for Neuroeconomics, Department of Economics, University of Zurich, Zurich, Switzerland; Department of Psychology, Ludwig Maximilian University Munich, Munich, Germany. Electronic address: alexander.soutschek@econ.uzh.ch.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Gvozdanovic', 'Affiliation': 'Zurich Center for Neuroeconomics, Department of Economics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Rouba', 'Initials': 'R', 'LastName': 'Kozak', 'Affiliation': 'Takeda Pharmaceuticals International, Cambridge, Massachusetts.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Duvvuri', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, Massachusetts.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'de Martinis', 'Affiliation': 'Takeda Pharmaceuticals International, Cambridge, Massachusetts.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Harel', 'Affiliation': 'Takeda Pharmaceuticals International, Cambridge, Massachusetts.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Gray', 'Affiliation': 'Cerevel Therapeutics, Boston, Massachusetts.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Fehr', 'Affiliation': 'Zurich Center for Neuroeconomics, Department of Economics, University of Zurich, Zurich, Switzerland; Neuroscience Center Zurich, University of Zurich, Swiss Federal Institute of Technology Zurich, Zurich, Switzerland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Jetter', 'Affiliation': 'Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Philippe N', 'Initials': 'PN', 'LastName': 'Tobler', 'Affiliation': 'Zurich Center for Neuroeconomics, Department of Economics, University of Zurich, Zurich, Switzerland; Neuroscience Center Zurich, University of Zurich, Swiss Federal Institute of Technology Zurich, Zurich, Switzerland.'}]",Biological psychiatry,['10.1016/j.biopsych.2019.09.002']
718,21653795,Early feeding and risk of type 1 diabetes: experiences from the Trial to Reduce Insulin-dependent diabetes mellitus in the Genetically at Risk (TRIGR).,"Short-term breastfeeding and early exposure to complex dietary proteins, such as cow milk proteins and cereals, or to fruit, berries, and roots have been implicated as risk factors for β cell autoimmunity, clinical type 1 diabetes, or both. The Trial to Reduce Insulin-dependent diabetes mellitus in the Genetically at Risk (TRIGR) is an international, randomized, double-blind, controlled intervention trial designed to answer the question of whether weaning to an extensively hydrolyzed formula in infancy will decrease the risk of type 1 diabetes later in childhood. In our pilot study, weaning to a highly hydrolyzed formula decreased by ≈ 50% the cumulative incidence of one or more diabetes-associated autoantibodies by a mean age of 4.7 y. This finding was confirmed in a recent follow-up analysis to 10 y of age. Currently, the full-scale TRIGR takes place in 77 centers in 15 countries. The TRIGR initially recruited 5606 newborn infants with a family member affected by type 1 diabetes and enrolled 2159 eligible subjects who carried a risk-conferring HLA genotype. All recruited mothers were encouraged to breastfeed. The intervention lasted for 6-8 mo with a minimum study formula exposure time of 2 mo, and hydrolyzed casein and standard cow milk-based weaning formulas were compared. Eighty percent of the participants were exposed to the study formula. The overall retention rate over the first 5 y was 87%, and protocol compliance was 94%. The randomization code will be opened when the last recruited child turns 10 y of age (ie, in 2017).",2011,"In our pilot study, weaning to a highly hydrolyzed formula decreased by ≈ 50% the cumulative incidence of one or more diabetes-associated autoantibodies by a mean age of 4.7 y.","['5606 newborn infants with a family member affected by type 1 diabetes and enrolled 2159 eligible subjects who carried a risk-conferring HLA genotype', 'dependent diabetes mellitus in the Genetically at Risk (TRIGR']","['Insulin', 'hydrolyzed casein and standard cow milk-based weaning formulas']","['overall retention rate', 'cumulative incidence of one or more diabetes-associated autoantibodies']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk (substance)""}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0004358', 'cui_str': 'Autoantibodies'}]",5606.0,0.0603649,"In our pilot study, weaning to a highly hydrolyzed formula decreased by ≈ 50% the cumulative incidence of one or more diabetes-associated autoantibodies by a mean age of 4.7 y.","[{'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Knip', 'Affiliation': 'Hospital for Children and Adolescents, University of Helsinki, Helsinki, Finland. mikael.knip@helsinki.fi'}, {'ForeName': 'Suvi M', 'Initials': 'SM', 'LastName': 'Virtanen', 'Affiliation': ''}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Becker', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Dupré', 'Affiliation': ''}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Krischer', 'Affiliation': ''}, {'ForeName': 'Hans K', 'Initials': 'HK', 'LastName': 'Åkerblom', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of clinical nutrition,['10.3945/ajcn.110.000711']
719,31615999,Analog Coupled Oscillator Based Weighted Ising Machine.,"We report on an analog computing system with coupled non-linear oscillators which is capable of solving complex combinatorial optimization problems using the weighted Ising model. The circuit is composed of a fully-connected 4-node LC oscillator network with low-cost electronic components and compatible with traditional integrated circuit technologies. We present the theoretical modeling, experimental characterization, and statistical analysis our system, demonstrating single-run ground state accuracies of 98% on randomized MAX-CUT problem sets with binary weights and 84% with 5-bit weight resolutions. Solutions are obtained within 5 oscillator cycles, and the time-to-solution has been demonstrated to scale directly with oscillator frequency. We present scaling analysis which suggests that large coupled oscillator networks may be used to solve computationally intensive problems faster and more efficiently than conventional algorithms. The proof-of-concept system presented here provides the foundation for realizing such larger scale systems using existing hardware technologies and could pave the way towards an entirely novel computing paradigm.",2019,We present scaling analysis which suggests that large coupled oscillator networks may be used to solve computationally intensive problems faster and more efficiently than conventional algorithms.,[],[],[],[],[],[],,0.0195964,We present scaling analysis which suggests that large coupled oscillator networks may be used to solve computationally intensive problems faster and more efficiently than conventional algorithms.,"[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Chou', 'Affiliation': 'Massachusetts Institute of Technology Lincoln Laboratory, Lexington, Massachusetts, USA.'}, {'ForeName': 'Suraj', 'Initials': 'S', 'LastName': 'Bramhavar', 'Affiliation': 'Massachusetts Institute of Technology Lincoln Laboratory, Lexington, Massachusetts, USA.'}, {'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Massachusetts Institute of Technology Lincoln Laboratory, Lexington, Massachusetts, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Herzog', 'Affiliation': 'Massachusetts Institute of Technology Lincoln Laboratory, Lexington, Massachusetts, USA. wherzog@ll.mit.edu.'}]",Scientific reports,['10.1038/s41598-019-49699-5']
720,31619756,Sub-optimality in motor planning is not improved by explicit observation of motor uncertainty.,"To make optimal decisions under risk, one must correctly weight potential rewards and penalties by the probabilities of receiving them. In motor decision tasks, the uncertainty in outcome is a consequence of motor uncertainty. When participants perform suboptimally as they often do in such tasks, it could be because they have insufficient information about their motor uncertainty: with more information, their performance could converge to optimal as they learn their own motor uncertainty. Alternatively, their suboptimal performance may reflect an inability to make use of the information they have or even to perform the correct computations. To discriminate between these two possibilities, we performed an experiment spanning two days. On the first day, all participants performed a reaching task with trial-by-trial feedback of motor error. At the end of the day, their aim points were still typically suboptimal. On the second day participants were divided into two groups one of which repeated the task of the first day and the other of which repeated the task but were intermittently given additional information summarizing their motor errors. Participants receiving additional information did not perform significantly better than those who did not.",2019,Participants receiving additional information did not perform significantly better than those who did not.,[],[],[],[],[],[],,0.0303025,Participants receiving additional information did not perform significantly better than those who did not.,"[{'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Ota', 'Affiliation': 'Department of Psychology, New York University, New York, USA. keiji.ota@nyu.edu.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Shinya', 'Affiliation': 'Department of Human Sciences, Graduate School of Integrated Arts and Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Laurence T', 'Initials': 'LT', 'LastName': 'Maloney', 'Affiliation': 'Department of Psychology, New York University, New York, USA.'}, {'ForeName': 'Kazutoshi', 'Initials': 'K', 'LastName': 'Kudo', 'Affiliation': 'Laboratory of Sports Sciences, Department of Life Sciences, Graduate School of Arts and Sciences, The University of Tokyo, Tokyo, Japan. kudo@idaten.c.u-tokyo.ac.jp.'}]",Scientific reports,['10.1038/s41598-019-50901-x']
721,31537332,Cardiac Resynchronization in Women: A Substudy of the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial.,"OBJECTIVES


This study sought to evaluate the effect of cardiac resynchronization therapy with defibrillator (CRT-D) as compared with implantable cardioverter-defibrillator (ICD) on mortality, heart failure (HF) hospitalization, and ventricular arrhythmia in women versus men.
BACKGROUND


CRT-D has demonstrated reduced mortality and HF hospitalizations with greater benefit observed in women compared with men. However, whether CRT-D prevented ventricular arrhythmias in women compared with men was unclear.
METHODS


The RAFT (Resynchronization-Defibrillation for Ambulatory Heart Failure Trial) study randomized 1,798 patients to an ICD or CRT-D. In this post hoc analysis, women and men were compared by randomized group. By using a multivariable model, the outcomes of death and HF hospitalization and incidence of ventricular arrhythmia were compared between men and women.
RESULTS


There were 1,490 (83%) men (732, ICD; 758, CRT-D) and 308 (17%) women (172, ICD; 136, CRT-D) included in the analysis. Women with CRT-D had a significantly reduced incidence of death and HF hospitalization compared with men with CRT-D (hazard ratio: 0.52; 95% confidence interval: 0.33 to 0.81; p < 0.001) on multivariable analysis. Women with a primary prevention indication and CRT-D had the lowest rate of ventricular arrhythmia compared with men (hazard ratio: 0.59; 95% confidence interval: 0.39 to 0.91; p = 0.016).
CONCLUSIONS


Women have improved rates of death and HF hospitalization with CRT-D and were less likely to experience ventricular arrhythmia when compared with men, after adjusting for differences in baseline characteristics over a prolonged follow-up. Whether these improved outcomes reflect inherent sex differences in the underlying myocardial substrate resulting in an enhanced response to CRT-D requires further research.",2019,Women with CRT-D had a significantly reduced incidence of death and HF hospitalization compared with men with CRT-D (hazard ratio: 0.52; 95% confidence interval: 0.33 to 0.81; p < 0.001) on multivariable analysis.,"['men and women', '1,798 patients to an ICD or CRT-D', 'Women', 'women versus men']","['Resynchronization-Defibrillation', 'RAFT (Resynchronization-Defibrillation', 'implantable cardioverter-defibrillator (ICD', 'Cardiac Resynchronization', 'cardiac resynchronization therapy with defibrillator (CRT-D', 'CRT-D']","['rates of death and HF hospitalization', 'lowest rate of ventricular arrhythmia', 'incidence of death and HF hospitalization', 'death and HF hospitalization and incidence of ventricular arrhythmia', 'mortality, heart failure (HF) hospitalization, and ventricular arrhythmia', 'mortality and HF hospitalizations', 'ventricular arrhythmias']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0336849', 'cui_str': 'Raft, device (physical object)'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}, {'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C0180307', 'cui_str': 'Defibrillators'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",1798.0,0.317147,Women with CRT-D had a significantly reduced incidence of death and HF hospitalization compared with men with CRT-D (hazard ratio: 0.52; 95% confidence interval: 0.33 to 0.81; p < 0.001) on multivariable analysis.,"[{'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'de Waard', 'Affiliation': 'Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Jaimie', 'Initials': 'J', 'LastName': 'Manlucu', 'Affiliation': 'London Health Sciences Center, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Gillis', 'Affiliation': 'Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sapp', 'Affiliation': 'Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Bernick', 'Affiliation': 'Ottawa Cardiovascular Research Methods Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Doucette', 'Affiliation': 'Research Methods Unit, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'London Health Sciences Center, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wells', 'Affiliation': 'Ottawa Cardiovascular Research Methods Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Ratika', 'Initials': 'R', 'LastName': 'Parkash', 'Affiliation': 'Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia, Canada. Electronic address: ratika.parkash@nshealth.ca.'}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2019.06.007']
722,31443958,"Re: Jonas Hugosson, Monique J. Roobol, Marianne Månsson, et al. A 16-yr Follow-up of the European Randomized Study of Screening for Prostate Cancer. Eur Urol 2019;76:43-51: Mortality in the Age Group ≥70 yr and the Case of Italy.",,2020,,[],[],[],[],[],[],,0.0347834,,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Donzelli', 'Affiliation': 'Fondazione Allineare Sanità e Salute, Milan, Italy. Electronic address: adonzelli1@libero.it.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Castelluzzo', 'Affiliation': 'Department of Hygiene, Public Health and Preventive Medicine, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Giudicatti', 'Affiliation': 'Department of Hygiene, Public Health and Preventive Medicine, University of Milano-Bicocca, Milan, Italy.'}]",European urology,['10.1016/j.eururo.2019.07.045']
723,32128614,"Transcutaneous electrical nerve stimulation for advanced cancer pain inpatients in specialist palliative care-a blinded, randomized, sham-controlled pilot cross-over trial.","PURPOSE


Transcutaneous electrical nerve stimulation (TENS) is a treatment option for cancer pain, but the evidence is inconclusive. We aimed to evaluate the efficacy and safety of TENS.
METHODS


A blinded, randomized, sham-controlled pilot cross-over trial (NCT02655289) was conducted on an inpatient specialist palliative care ward. We included adult inpatients with cancer pain ≥ 3 on an 11-point numerical rating scale (NRS). Intensity-modulated high TENS (IMT) was compared with placebo TENS (PBT). Patients used both modes according to their preferred application scheme during 24 h with a 24-h washout phase. The primary outcome was change in average pain intensity on the NRS during the preceding 24 h. Responders were patients with at least a ""slight improvement.""
RESULTS


Of 632 patients screened, 25 were randomized (sequence IMT-PBT = 13 and PBT-IMT = 12). Finally, 11 patients in IMT-PBT and 9 in PBT-IMT completed the study (N = 20). The primary outcome did not differ between groups (IMT minus PBT: - 0.2, 95% confidence interval - 0.9 to 0.6). However, responder rates were higher in IMT (17/20 [85%] vs. 10/20 [50%], p = 0.0428). Two patients experienced an uncomfortable feeling caused by the current, one after IMT and one after PBT. Seven patients (35%) desired a TENS prescription. Women and patients with incident pain were most likely to benefit from TENS.
CONCLUSION


TENS was safe, but IMT was unlikely to offer more analgesic effects than PBT. Even though many patients desired a TENS prescription, 50% still reported at least ""slight pain relief"" from PBT. Differences for gender and incident pain aspects demand future trials.",2020,"The primary outcome did not differ between groups (IMT minus PBT: - 0.2, 95% confidence interval - 0.9 to 0.6).","['11 patients in IMT-PBT and 9 in PBT-IMT completed the study (N\u2009=\u200920', '632 patients screened, 25', 'advanced cancer pain inpatients in specialist palliative care', 'adult inpatients with cancer pain ≥\u20093 on an 11-point numerical rating scale (NRS', 'inpatient specialist palliative care ward', 'Women and patients with incident pain']","['Transcutaneous electrical nerve stimulation (TENS', 'placebo TENS (PBT', 'Intensity-modulated high TENS (IMT', 'TENS', 'Transcutaneous electrical nerve stimulation']","['average pain intensity', 'uncomfortable feeling', 'slight improvement', 'analgesic effects', 'responder rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1273400', 'cui_str': 'Specialist palliative care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0222045'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C2937276', 'cui_str': 'Slight (qualifier value)'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",25.0,0.274577,"The primary outcome did not differ between groups (IMT minus PBT: - 0.2, 95% confidence interval - 0.9 to 0.6).","[{'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Siemens', 'Affiliation': 'Clinic for Palliative Care, Medical Center, Faculty of Medicine, University of Freiburg, Robert-Koch-Str 3, 79106, Freiburg, Germany. waldemar.siemens@googlemail.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Boehlke', 'Affiliation': 'Clinic for Palliative Care, Medical Center, Faculty of Medicine, University of Freiburg, Robert-Koch-Str 3, 79106, Freiburg, Germany.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Bennett', 'Affiliation': 'Academic Unit of Palliative Care, Leeds Institute of Health Sciences (LIHS), School of Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Offner', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Gerhild', 'Initials': 'G', 'LastName': 'Becker', 'Affiliation': 'Clinic for Palliative Care, Medical Center, Faculty of Medicine, University of Freiburg, Robert-Koch-Str 3, 79106, Freiburg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gaertner', 'Affiliation': 'Center for Palliative Care Hildegard, Basel, Switzerland.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05370-8']
724,31607613,Patient Involvement in the Design of a Randomised Trial of Proton Beam Radiotherapy Versus Standard Radiotherapy for Good Prognosis Glioma.,,2020,,[],['Proton Beam Radiotherapy Versus Standard Radiotherapy'],[],[],"[{'cui': 'C0729603', 'cui_str': 'Proton beam (physical force)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",[],,0.0774835,,"[{'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Powell', 'Affiliation': 'Department of Oncology, Velindre University NHS Trust, Cardiff, UK. Electronic address: james.powell2@wales.nhs.uk.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Murray', 'Affiliation': ""St James's Hospital and Leeds Institute of Medical Research, University of Leeds, Leeds, UK.""}, {'ForeName': 'N G', 'Initials': 'NG', 'LastName': 'Burnet', 'Affiliation': 'Division of Cancer Sciences, Manchester Cancer Research Centre, University of Manchester, Manchester, UK; Department of Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fernandez', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Lingard', 'Affiliation': 'Division of Cancer Sciences, Manchester Cancer Research Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'McParland', 'Affiliation': 'Department of Oncology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': ""O'Hara"", 'Affiliation': 'Clinical and Health Psychology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Whitfield', 'Affiliation': 'Division of Cancer Sciences, Manchester Cancer Research Centre, University of Manchester, Manchester, UK; Department of Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Short', 'Affiliation': ""St James's Hospital and Leeds Institute of Medical Research, University of Leeds, Leeds, UK.""}]",Clinical oncology (Royal College of Radiologists (Great Britain)),['10.1016/j.clon.2019.09.049']
725,32073800,[Morning or evening; What is the best time to take antihypertensive drugs?],"Various studies suggest that evening dosing of antihypertensive drugs may be more effective. In line, a randomized open-label trial in 19,084 hypertensive patients recently demonstrated that evening dosing of at least one antihypertensive drug resulted in a 3.3 mmHg lower systolic night-time blood pressure and 1.3 mmHg lower systolic 48-hour blood pressure when compared to morning dosing. Cardiovascular outcomes were reduced by 45% in the evening dosing group, which is remarkable as previous meta-analyses have shown that a systolic blood pressure reduction of 3 mmHg is associated with a 7% reduction in cardiovascular outcome. Although this discrepancy may be partly explained by specific beneficial effects related to evening dosing, it is likely that the open-label trial design may have affected the study outcome in different ways. Also, the safety of evening dosing in elderly hypertensive patients and the consequences for therapy compliance in the clinical setting remain to be established.",2020,"Cardiovascular outcomes were reduced by 45% in the evening dosing group, which is remarkable as previous meta-analyses have shown that a systolic blood pressure reduction of 3 mmHg is associated with a 7% reduction in cardiovascular outcome.","['elderly hypertensive patients', '19,084 hypertensive patients']",[],"['cardiovascular outcome', 'systolic night-time blood pressure and 1.3 mmHg lower systolic 48-hour blood pressure', 'Cardiovascular outcomes', 'systolic blood pressure reduction']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",19084.0,0.0507875,"Cardiovascular outcomes were reduced by 45% in the evening dosing group, which is remarkable as previous meta-analyses have shown that a systolic blood pressure reduction of 3 mmHg is associated with a 7% reduction in cardiovascular outcome.","[{'ForeName': 'Rik H G', 'Initials': 'RHG', 'LastName': 'Olde Engberink', 'Affiliation': 'Amsterdam UMC, locatie AMC, afd. Inwendige Geneeskunde, Amsterdam.'}, {'ForeName': 'Bert-Jan H', 'Initials': 'BH', 'LastName': 'van den Born', 'Affiliation': 'Amsterdam UMC, locatie AMC, afd. Inwendige Geneeskunde, Amsterdam.'}]",Nederlands tijdschrift voor geneeskunde,[]
726,31524502,Effects of Taichi exercise on knee and ankle proprioception among individuals with knee osteoarthritis.,"The study aimed to investigate the effects of 24 weeks Taichi intervention on knee and ankle proprioception amongst individuals with knee osteoarthritis (KOA). Ninety-two patients with KOA were included in the current study, involving 52 participants in the intervention group and 40 participants in the control group. The intervention group performed Taichi exercise for 24 weeks, the control group accepted the health education lectures. The main outcome of this study was the proprioception of the knee and ankle which was measured by an electric-driven movable frame. Between- and within-group differences were evaluated through the repeated-measurement ANOVA. For the Taichi group, the differences in the changes in ankle proprioception were significant on ankle plantarflexion (p = 0.03), ankle dorsiflexion (p = 0.043), ankle varus (p = 0.019) and knee flexion (p = 0.01) between the baseline and post-test measures. Twenty-four weeks Taichi exercise may improve the ankle and knee proprioception of patients with KOA.",2020,"For the Taichi group, the differences in the changes in ankle proprioception were significant on ankle plantarflexion (p = 0.03), ankle dorsiflexion (p = 0.043), ankle varus (p = 0.019) and knee flexion (p = 0.01) between the baseline and post-test measures.","['individuals with knee osteoarthritis (KOA', 'Ninety-two patients with KOA were included in the current study, involving 52 participants in the intervention group and 40 participants in the control group', 'individuals with knee osteoarthritis', 'patients with KOA']","['Taichi intervention', 'Taichi exercise', 'control group accepted the health education lectures']","['knee and ankle proprioception', 'ankle varus', 'knee flexion', 'ankle and knee proprioception', 'proprioception of the knee and ankle which was measured by an electric-driven movable frame', 'ankle proprioception', 'ankle dorsiflexion', 'ankle plantarflexion']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0018701'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0443345', 'cui_str': 'Varus (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}]",52.0,0.0303919,"For the Taichi group, the differences in the changes in ankle proprioception were significant on ankle plantarflexion (p = 0.03), ankle dorsiflexion (p = 0.043), ankle varus (p = 0.019) and knee flexion (p = 0.01) between the baseline and post-test measures.","[{'ForeName': 'Xiaoyue', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Key Laboratory of Exercise and Health Science of the Ministry of Education, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Zhangqi', 'Initials': 'Z', 'LastName': 'Lai', 'Affiliation': 'Key Laboratory of Exercise and Health Science of the Ministry of Education, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Exercise and Health Science of the Ministry of Education, Shanghai University of Sport, Shanghai, China.'}]",Research in sports medicine (Print),['10.1080/15438627.2019.1663520']
727,31927698,Real-World Data and Randomised Controlled Trials: The Salford Lung Study.,"Traditional efficacy double-blind randomised controlled trials (DBRCTs) measure the benefit a treatment produces under near-ideal test conditions in highly selected patient populations; however, the behaviour of patients and investigators in such trials is highly controlled, highly compliant and adherent, and non-representative of routine clinical practice. Pragmatic effectiveness trials measure the benefit a treatment produces in patients in everyday ""real-world"" practice. Ideally, effectiveness trials should recruit patients as similar as possible to those who will ultimately be prescribed the medicine, and create freedom within the study design to allow normal behaviours of patients and healthcare professionals (HCPs) to be expressed. The Salford Lung Study (SLS) was a world-first, prospective, phase III, pragmatic randomised controlled trial (RCT) programme in patients with chronic obstructive pulmonary disease and asthma to evaluate the effectiveness of a pre-licensed medication (fluticasone furoate/vilanterol) in real-world practice using electronic health records and through collaboratively engaging general practitioners and community pharmacists in clinical research. The real-world aspect of SLS was unique, requiring careful planning and attention to the goals of maximising the external validity of the trials while maintaining scientific rigour and securing suitable electronic processes for proper interpretation of safety data. Key learnings from SLS that may inform the design of future pragmatic effectiveness RCTs include: (1) ensuring the trial setting and operational infrastructure are aligned with routine clinical care; (2) recruiting a broad patient population with characteristics as close as possible to patients in routine clinical practice, to maximise the generalisability and applicability of trial results; (3) ensuring that patients and HCPs are suitably engaged in the trial, to maximise the chances of successful trial delivery; and (4) careful study design, incorporating outcomes of value to patients, HCPs, policymakers and payers, and using pre-planned analyses to address scientifically valid research hypotheses to ensure robustness of the trial data.",2020,"Traditional efficacy double-blind randomised controlled trials (DBRCTs) measure the benefit a treatment produces under near-ideal test conditions in highly selected patient populations; however, the behaviour of patients and investigators in such trials is highly controlled, highly compliant and adherent, and non-representative of routine clinical practice.","['patients with chronic obstructive pulmonary disease and asthma', 'highly selected patient populations', 'patients in everyday ""real-world"" practice']",['pre-licensed medication (fluticasone furoate/vilanterol'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0023636', 'cui_str': 'Permits'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}]",[],,0.228398,"Traditional efficacy double-blind randomised controlled trials (DBRCTs) measure the benefit a treatment produces under near-ideal test conditions in highly selected patient populations; however, the behaviour of patients and investigators in such trials is highly controlled, highly compliant and adherent, and non-representative of routine clinical practice.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Leather', 'Affiliation': 'Global Respiratory Franchise, GlaxoSmithKline plc., Brentford, Middlesex, UK. david.a.leather@gsk.com.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Community and Primary Health Care, Faculty of Health, Plymouth University, Plymouth, UK.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Woodcock', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Sciences Centre, The University of Manchester and Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Vestbo', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Sciences Centre, The University of Manchester and Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Jacques', 'Affiliation': 'Clinical Sciences, GlaxoSmithKline plc., Uxbridge, Middlesex, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}]",Advances in therapy,['10.1007/s12325-019-01192-1']
728,31960580,"Estimating the costs and cost-effectiveness of HIV self-testing among men who have sex with men, United States.","INTRODUCTION


HIV testing is an essential prerequisite for accessing treatment with antiretroviral therapy or prevention using pre-exposure prophylaxis. Internet distribution of HIV self-tests is a novel approach, and data on the programmatic cost of this approach are limited. We analyse the costs and cost-effectiveness of a self-testing programme.
METHODS


Men who have sex with men (MSM) reporting unknown or negative HIV status were enrolled from March to August 2015 into a 12-month trial of HIV self-testing in the United States. Participants were randomly assigned either to the self-testing arm or the control arm. All participants received information on HIV testing services and locations in their community. Self-testing participants received up to four self-tests each quarter, which they could use themselves or distribute to their social network associates. Quarterly follow-up surveys collected testing outcomes, including number of tests used and new HIV diagnoses. Using trial expenditure data, we estimated the cost of implementing a self-testing programme. Primary outcomes of this analysis included total programme implementation costs, cost per self-test completed, cost per person tested, cost per new HIV diagnosis among those self-tested and cost per quality adjusted life year (QALY) saved.
RESULTS


A total of 2665 men were assigned either to the self-testing arm (n = 1325) or the control arm (n = 1340). HIV testing was reported by 971 self-testing participants who completed a total of 5368 tests. In the control arm, 619 participants completed 1463 HIV tests. The self-testing participants additionally distributed 2864 self-tests to 2152 social network associates. Testing during the trial identified 59 participants and social network associates with newly diagnosed HIV infection in the self-testing arm; 11 control participants were newly diagnosed with HIV. The implementation cost of the HIV self-testing programme was $449,510. The cost per self-test completed, cost per person tested at least once, and incremental cost per new HIV diagnosis was $61, $145 and $9365 respectively. We estimated that self-testing programme potentially averted 3.34 transmissions, saved 14.86 QALYs and nearly $1.6 million lifetime HIV treatment costs.
CONCLUSIONS


The HIV self-testing programme identified persons with newly diagnosed HIV infection at low cost, and the programme is cost saving.",2020,"The HIV self-testing programme identified persons with newly diagnosed HIV infection at low cost, and the programme is cost saving.","['971 self-testing participants who completed a total of 5368 tests', '619 participants completed 1463 HIV tests', 'Men who have sex with men (MSM) reporting unknown or negative HIV status were enrolled from March to August 2015 into a 12-month trial of HIV self-testing in the United States', '59 participants and social network associates with newly diagnosed HIV infection in the self-testing arm; 11 control participants were newly diagnosed with HIV', 'men who have sex with men, United States', 'A total of 2665 men']",['HIV self-testing'],"['number of tests used and new HIV diagnoses', 'total programme implementation costs, cost per self-test completed, cost per person tested, cost per new HIV diagnosis among those self-tested and cost per quality adjusted life year (QALY) saved', 'costs and cost-effectiveness', 'incremental cost per new HIV diagnosis']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1321876', 'cui_str': 'Human immunodeficiency virus test (procedure)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",2665.0,0.0276086,"The HIV self-testing programme identified persons with newly diagnosed HIV infection at low cost, and the programme is cost saving.","[{'ForeName': 'Ram K', 'Initials': 'RK', 'LastName': 'Shrestha', 'Affiliation': 'Centers for Disease Control and Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Pollyanna R', 'Initials': 'PR', 'LastName': 'Chavez', 'Affiliation': 'Centers for Disease Control and Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Noble', 'Affiliation': 'Evidence Solutions Group, Hayes Inc., Dallas, TX, USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Sansom', 'Affiliation': 'Centers for Disease Control and Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Sullivan', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Mermin', 'Affiliation': 'Centers for Disease Control and Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'MacGowan', 'Affiliation': 'Centers for Disease Control and Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Atlanta, GA, USA.'}]",Journal of the International AIDS Society,['10.1002/jia2.25445']
729,32427675,Allogenic Fecal Microbiota Transplantation in Patients With Nonalcoholic Fatty Liver Disease Improves Abnormal Small Intestinal Permeability: A Randomized Control Trial.,"INTRODUCTION


Nonalcoholic fatty liver disease (NAFLD) is an obesity-related disorder that is rapidly increasing in incidence and is considered the hepatic manifestation of the metabolic syndrome. The gut microbiome plays a role in metabolism and maintaining gut barrier integrity. Studies have found differences in the microbiota between NAFLD and healthy patients and increased intestinal permeability in patients with NAFLD. Fecal microbiota transplantation (FMT) can be used to alter the gut microbiome. It was hypothesized that an FMT from a thin and healthy donor given to patients with NAFLD would improve insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability.
METHODS


Twenty-one patients with NAFLD were recruited and randomized in a ratio of 3:1 to either an allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum. IR was calculated by HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability was tested using the lactulose:mannitol urine test. Additional markers of metabolic syndrome and the gut microbiota were examined. Patient visits occurred at baseline, 2, 6 weeks, and 6 months post-FMT.
RESULTS


There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT. Allogenic FMT patients with elevated small intestinal permeability (>0.025 lactulose:mannitol, n = 7) at baseline had a significant reduction 6 weeks after allogenic FMT.
DISCUSSION


FMT did not improve IR as measured by HOMA-IR or hepatic PDFF but did have the potential to reduce small intestinal permeability in patients with NAFLD.",2020,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"['Patients With Nonalcoholic Fatty Liver Disease Improves', 'patients with NAFLD', 'Twenty-one patients with NAFLD', 'Abnormal Small Intestinal Permeability']","['Allogenic Fecal Microbiota Transplantation', 'Fecal microbiota transplantation (FMT', 'allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum', 'FMT', 'allogenic or autologous FMT', 'Allogenic FMT']","['HOMA-IR or hepatic PDFF', 'Patient visits', 'intestinal permeability', 'insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability', 'small intestinal permeability', 'HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",21.0,0.0335215,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Craven', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nair Parvathy', 'Affiliation': ""Division of Infectious Disease, St. Joseph's Health Care, London, Ontario, Canada.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Beaton', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Silverman', 'Affiliation': 'Program in Computational Biology and Bioinformatics, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Qumosani', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Hramiak', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Hegele', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Tisha', 'Initials': 'T', 'LastName': 'Joy', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Meddings', 'Affiliation': 'Department of Medicine, University of Calgary, Alberta, Canada.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Urquhart', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Harvie', 'Affiliation': 'The Canadian Centre for Microbiome and Probiotic Research, London, Ontario, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McKenzie', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Summers', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Reid', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Burton', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000661']
730,31522894,Impact of a Pilot School-Based Nutrition Intervention on Fruit and Vegetable Waste at School Lunches.,"OBJECTIVE


To determine the preliminary impact of the Brighter Bites nutrition intervention on decreasing fruit and vegetable (F&V) waste at school lunches among fourth- and fifth-grade children.
METHOD


This was a nonrandomized pre-post-controlled study in Houston and Dallas, TX. Two schools received the Brighter Bites intervention (n = 76), and 1 comparison school (n = 39), during the 2017-2018 school year. Brighter Bites is a 16-week school-based nutrition intervention providing weekly distribution of fresh F&V plus nutrition education. Main outcome measures were direct observation and weights to measure the number of F&V dishes selected at school lunches, amount of F&V wasted (gm), and related nutrient waste (4 time points/child). Mixed-effects linear regression analysis was used to determine change in F&V selection and waste over time.
RESULTS


There was a significant decrease over time in proportion of F&V selected among those in the comparison school, but not the intervention schools (P < .001). Compared with children in the comparison group, those receiving Brighter Bites showed a significant decrease in the amount of F&V wasted at each meal (P < .001) and per item (P < .05) at the end of both 8 and 16 weeks of intervention. There were significant decreases in waste of energy (kcal); dietary fiber (gm); vitamins B 1 , B 3 , and B 6  (mg); total folate (µg); and B 12  (µg) among those receiving Brighter Bites (P < .05).
CONCLUSIONS AND IMPLICATIONS


Although absolute food or nutrient changes were small even when significant, programs such as Brighter Bites may contribute to a healthy intake. Future studies are warranted that include a larger sample size with a stringent, cluster-randomized control trial design and consideration for other covariates.",2019,"There were significant decreases in waste of energy (kcal); dietary fiber (gm); vitamins B 1 , B 3 , and B 6  (mg); total folate (µg); and B 12  (µg) among those receiving Brighter Bites (P < .05).
","['Fruit and Vegetable Waste at School Lunches', 'at school lunches among fourth- and fifth-grade children']","['Pilot School-Based Nutrition Intervention', 'Brighter Bites intervention', 'Brighter Bites nutrition intervention']","['fruit and vegetable (F&V) waste', 'waste of energy (kcal); dietary fiber (gm); vitamins B 1 , B 3 , and B 6  (mg); total folate', 'amount of F&V', 'time in proportion of F&V', 'F&V selection and waste over time', 'direct observation and weights to measure the number of F&V dishes selected at school lunches, amount of F&V wasted (gm), and related nutrient waste (4 time points/child']","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0235394', 'cui_str': 'Wasting'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0423899', 'cui_str': 'Gifted (observable entity)'}, {'cui': 'C0005658', 'cui_str': 'Bites'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0235394', 'cui_str': 'Wasting'}, {'cui': 'C0012173', 'cui_str': 'Dietary Fiber'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0020498', 'cui_str': 'Vertebral Ankylosing Hyperostosis'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",,0.0211794,"There were significant decreases in waste of energy (kcal); dietary fiber (gm); vitamins B 1 , B 3 , and B 6  (mg); total folate (µg); and B 12  (µg) among those receiving Brighter Bites (P < .05).
","[{'ForeName': 'Shreela', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Epidemiology, Environmental Health, and Genetics, Michael and Susan Dell Center for Healthy Living, University of Texas School of Public Health, Houston, TX. Electronic address: Shreela.V.Sharma@uth.tmc.edu.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Marshall', 'Affiliation': 'Michael and Susan Dell Center for Healthy Living, University of Texas School of Public Health in Austin, Austin, TX.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Chow', 'Affiliation': 'Department of Health Promotion Behavioral Sciences, University of Texas School of Public Health, Houston, TX.'}, {'ForeName': 'Nalini', 'Initials': 'N', 'LastName': 'Ranjit', 'Affiliation': 'Michael and Susan Dell Center for Healthy Living, University of Texas School of Public Health in Austin, Austin, TX.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Bounds', 'Affiliation': 'Department of Health Promotion Behavioral Sciences, University of Texas School of Public Health, Houston, TX.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hearne', 'Affiliation': 'Department of Health Promotion Behavioral Sciences, University of Texas School of Public Health, Houston, TX.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Cramer', 'Affiliation': 'Houston Independent School District Food Service Support Facility, Houston, TX.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Oceguera', 'Affiliation': 'Houston Independent School District Food Service Support Facility, Houston, TX.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Farhat', 'Affiliation': 'Brighter Bites, Dallas, TX.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Markham', 'Affiliation': 'Department of Health Promotion Behavioral Sciences, University of Texas School of Public Health, Houston, TX.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.08.002']
731,31522082,Effects of timing of acute catechin-rich green tea ingestion on postprandial glucose metabolism in healthy men.,"Green tea polyphenols, particularly catechins, decrease fasting and postprandial glucose. However, no studies have compared the timing of green tea ingestion on glucose metabolism and changes in catechin concentrations. Here, we examined the effects of timing of acute catechin-rich green tea ingestion on postprandial glucose metabolism in young men. Seventeen healthy young men completed four trials involving blood collection in a fasting state and at 30, 60, 120, and 180 min after meal consumption in a random order: 1) morning placebo trial (09:00 h; MP trial), 2) evening placebo trial (17:00 h; EP trial), 3) morning catechin-rich green tea trial (09:00 h; MGT trial), and 4) evening catechin-rich green tea trial (17:00 h; EGT trial). The concentrations of glucose at 120 min (P=.031) and 180 min (P=.013) after meal intake were significantly higher in the MGT trials than in the MP trials. Additionally, the concentration of glucose was significantly lower in EGT trials than in the EP trials at 60 min (P=.014). Moreover, the concentrations of glucose-dependent insulinotropic polypeptide were significantly lower in the green tea trials than in the placebo trials at 30 min (morning: P=.010, evening: P=.006) and 60 min (morning: P=.001, evening: P=.006) after meal intake in both the morning and evening trials. Our study demonstrated that acute ingestion of catechin-rich green tea in the evening reduced postprandial plasma glucose concentrations.",2019,The concentrations of glucose at 120 min (P=.031) and 180 min (P=.013) after meal intake were significantly higher in the MGT trials than in the MP trials.,"['young men', 'healthy men', 'Seventeen healthy young men']","['placebo', 'acute catechin-rich green tea ingestion', 'catechin-rich green tea']","['postprandial plasma glucose concentrations', 'concentration of glucose', 'glucose metabolism and changes in catechin concentrations', 'concentrations of glucose', 'fasting and postprandial glucose', 'postprandial glucose metabolism', 'concentrations of glucose-dependent insulinotropic polypeptide']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0007404', 'cui_str': 'Catechin'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C1384640', 'cui_str': 'Green Tea'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0007404', 'cui_str': 'Catechin'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1305923', 'cui_str': 'Polypeptides'}]",17.0,0.268856,The concentrations of glucose at 120 min (P=.031) and 180 min (P=.013) after meal intake were significantly higher in the MGT trials than in the MP trials.,"[{'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Waseda Bioscience Research Institute in Singapore, Waseda University, 11 Biopolis Way, Singapore 138667, Singapore. Electronic address: m-takahashi@aoni.waseda.jp.'}, {'ForeName': 'Mamiho', 'Initials': 'M', 'LastName': 'Ozaki', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 1628480, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Miyashita', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, 2-579-15 Mikajima Tokorozawa, Saitama 3591192, Japan.'}, {'ForeName': 'Mayuko', 'Initials': 'M', 'LastName': 'Fukazawa', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 1628480, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nakaoka', 'Affiliation': ""Department of Medicine, Tokyo Women's Medical University, Medical Center East, 2-1-10 Nishiogu Arakawa, Tokyo 1168567, Japan.""}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Wakisaka', 'Affiliation': 'R&D, Core Technology, Biological Science Research, Kao Corporation, 2-1-3 Bunka Sumida, Tokyo 1318501, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Matsui', 'Affiliation': 'R&D, Core Technology, Biological Science Research, Kao Corporation, 2-1-3 Bunka Sumida, Tokyo 1318501, Japan.'}, {'ForeName': 'Masanobu', 'Initials': 'M', 'LastName': 'Hibi', 'Affiliation': 'R&D, Core Technology, Biological Science Research, Kao Corporation, 2-1-3 Bunka Sumida, Tokyo 1318501, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Osaki', 'Affiliation': 'R&D, Core Technology, Biological Science Research, Kao Corporation, 2-1-3 Bunka Sumida, Tokyo 1318501, Japan.'}, {'ForeName': 'Shigenobu', 'Initials': 'S', 'LastName': 'Shibata', 'Affiliation': 'Faculty of Science and Engineering, Waseda University, 2-2 Wakamatsu-cho, Shinjuku, Tokyo 1628480, Japan.'}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2019.108221']
732,32439135,"Effect of supportive counseling on pregnancy-specific stress, general stress, and prenatal health behaviors: A multicenter randomized controlled trial.","OBJECTIVE


The aim of this study was to investigate the effects of group supportive counseling (SC) on pregnancy-specific stress, general stress, and healthy behavior of pregnant women.
METHODS


This randomized controlled trial study was conducted on 80 pregnant women in two groups; SC for six sessions, once a week for two hours (n = 40), and antenatal usual care (AUC) (n = 40). All Participants completed questionnaires measuring pregnancy-specific stress, state anxiety, prenatal health behaviors, perceived stress, and provided a saliva sample for measurement of cortisol at pre-intervention and 6-week post-intervention.
RESULTS


The post-intervention results indicated that the outcome scores decreased more significantly in group SC than in the AUC for total NuPDQ, for state-anxiety, for PSS-14, and for unhealthy behaviors with a large effect size. Also, healthy behaviors were promoted more significantly in SC group than in AUC. However, salivary cortisol levels did not differ between group SC and AUC groups.
CONCLUSION


Group supportive counselling can promote pregnancy stress and healthy behaviors.
PRACTICE IMPLICATIONS


Addition of supportive counseling to prenatal usual care may be suggested for pregnant women with any gestational age who seek methods for improving pregnancy stress and healthy behaviors.",2020,"The post-intervention results indicated that the outcome scores decreased more significantly in group SC than in the AUC for total NuPDQ, for state-anxiety, for PSS-14, and for unhealthy behaviors with a large effect size.","['pregnant women with any gestational age', '80 pregnant women in two groups', 'pregnant women']","['group supportive counseling (SC', 'antenatal usual care (AUC', 'SC', 'supportive counseling']","['pregnancy stress and healthy behaviors', 'pregnancy-specific stress, general stress, and healthy behavior', 'total NuPDQ, for state-anxiety', 'pregnancy-specific stress, general stress, and prenatal health behaviors', 'salivary cortisol levels', 'questionnaires measuring pregnancy-specific stress, state anxiety, prenatal health behaviors, perceived stress, and provided a saliva sample for measurement of cortisol', 'healthy behaviors']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3697360', 'cui_str': 'Supportive counseling'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C1321108', 'cui_str': 'Prenatal health behavior'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",80.0,0.0769546,"The post-intervention results indicated that the outcome scores decreased more significantly in group SC than in the AUC for total NuPDQ, for state-anxiety, for PSS-14, and for unhealthy behaviors with a large effect size.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Esfandiari', 'Affiliation': 'Student Research Committee, Babol University of Medical Sciences, Babol, Iran. Electronic address: maryeikimm@gmail.com.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: mahbob330@yahoo.com.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Nasiri-Amiri', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, IR Iran. Electronic address: nasiri_fa@yahoo.com.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Parsian', 'Affiliation': 'Cellular and Molecular Biology Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: hadiparsian@yahoo.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Chehrazi', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, Babol University of Medical Sciences, Babol, Iran. Electronic address: mohamadchehrazi@gmail.com.'}, {'ForeName': 'Hajar', 'Initials': 'H', 'LastName': 'Pasha', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: dhajarpasha@gmail.com.'}, {'ForeName': 'Shabnam', 'Initials': 'S', 'LastName': 'Omidvar', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: shomidvar@yahoo.com.'}, {'ForeName': 'Hemmat', 'Initials': 'H', 'LastName': 'Gholinia', 'Affiliation': 'Social Determinants of Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: h_gholonia@yahoo.com.'}]",Patient education and counseling,['10.1016/j.pec.2020.04.024']
733,32073978,"Re: Ten-Year Mortality, Disease Progression, and Treatment-Related Side Effects in Men with Localised Prostate Cancer from the ProtecT Randomised Controlled Trial According to Treatment Received.",,2020,,['Men with Localised Prostate Cancer from the ProtecT Randomised Controlled Trial'],[],[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],[],,0.0747124,,"[{'ForeName': 'Samir S', 'Initials': 'SS', 'LastName': 'Taneja', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000000779.02']
734,32116155,"Recanalization following Endovascular treatment and imaging of PErfusion, Regional inFarction and atrophy to Understand Stroke Evolution-NA1 (REPERFUSE-NA1).","RATIONALE


Following endovascular treatment, poor clinical outcomes are more frequent if the initial infarct core or volume of irreversible brain damage is large. Clinical outcomes may be improved using neuroprotective agents that reduce stroke volume and improve recovery.
AIM


The aim of the REPERFUSE NA1 was to replicate the preclinical neuroprotection study that significantly reduced infarct volume in a primate model of ischemia reperfusion. Specifically, REPERFUSE NA1 will determine if administration of the neuroprotectant NA1 prior to endovascular therapy can significantly reduce early (Day 2 subtract Day 1 diffusion-weighted imaging volume) and delayed secondary infarct (90-day whole brain atrophy plus FLAIR volume-Day 1 diffusion-weighted imaging volume) growth, as measured by magnetic resonance imaging.
METHODS AND DESIGN


REPERFUSE-NA1 is a magnetic resonance imaging observational substudy of ESCAPE-NA1 (ClinicalTrialGov NCT02930018). A total of 150 acute stroke patients will be recruited (including 20% attrition) that have been randomized to either NA1 or placebo in the ESCAPE-NA1 trial.
STUDY OUTCOMES


Primary-Early infarct growth measured using diffusion-weighted imaging will be at least 30% smaller in patients receiving NA1 compared to placebo. Secondary-Delayed secondary stroke injury at 90 days will be significantly reduced in patients receiving NA1 compared to placebo, as well as delayed secondary growth at 90 days.
CONCLUSION


REPERFUSE-NA1 will demonstrate the effect of NA1 neuroprotection on reducing the early and delayed stroke injury after reperfusion treatment.",2020,Primary-Early infarct growth measured using diffusion-weighted imaging will be at least 30% smaller in patients receiving NA1 compared to placebo.,['150 acute stroke patients'],"['placebo', 'NA1 or placebo']",['stroke volume and improve recovery'],"[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",150.0,0.21528,Primary-Early infarct growth measured using diffusion-weighted imaging will be at least 30% smaller in patients receiving NA1 compared to placebo.,"[{'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Tariq', 'Affiliation': 'Department of Clinical Neurosciences, Foothills Medical Centre, Calgary, Canada.'}, {'ForeName': 'Rani Gupta', 'Initials': 'RG', 'LastName': 'Sah', 'Affiliation': 'Department of Clinical Neurosciences, Foothills Medical Centre, Calgary, Canada.'}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Chan', 'Affiliation': 'Department of Clinical Neurosciences, Foothills Medical Centre, Calgary, Canada.'}, {'ForeName': 'Deepthi', 'Initials': 'D', 'LastName': 'Rajashekar', 'Affiliation': 'Hotchkiss Brain Institute, Foothills Medical Center, Health Research Innovation Center, Calgary, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'McTaggart', 'Affiliation': 'Department of Neurology and Neurosurgery, Rhode Island Medical Imaging, Providence, RI, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Butcher', 'Affiliation': 'Division of Neurology, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Aviv', 'Affiliation': 'Department of Medical Imaging, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Swartz', 'Affiliation': 'Department of Medical Imaging, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Thalia', 'Initials': 'T', 'LastName': 'Field', 'Affiliation': 'Department of Neurology, Gordon and Leslie Diamond, Health Care Centre, Vancouver, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Tarpley', 'Affiliation': 'Pacific Neuroscience Institute, Providence Little Company of Mary Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Ruchir', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'UT Erlanger Neurology, Chattanooga, TN, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Department of Clinical Neurosciences, Foothills Medical Centre, Calgary, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Demchuk', 'Affiliation': 'Department of Clinical Neurosciences, Foothills Medical Centre, Calgary, Canada.'}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': 'Department of Clinical Neurosciences, Foothills Medical Centre, Calgary, Canada.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': ""d'Esterre"", 'Affiliation': 'Department of Clinical Neurosciences, Foothills Medical Centre, Calgary, Canada.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Barber', 'Affiliation': 'Department of Clinical Neurosciences, Foothills Medical Centre, Calgary, Canada.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493019895666']
735,32054652,Impact of idelalisib on health-related quality of life in patients with relapsed chronic lymphocytic leukemia in a phase 3 randomized trial.,,2020,,['patients with relapsed chronic lymphocytic leukemia'],['idelalisib'],['health-related quality of life'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}]","[{'cui': 'C2698692', 'cui_str': 'idelalisib'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.0582542,,"[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': 'Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milano, Italy; ghia.paolo@hsr.it.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Coutre', 'Affiliation': 'Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Georgetown University Hospital, Washington D.C., USA.'}, {'ForeName': 'Jacqueline C', 'Initials': 'JC', 'LastName': 'Barrientos', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""St. James's University Hospital, Leeds, UK.""}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Pettitt', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Zelenetz', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Sanatan', 'Initials': 'S', 'LastName': 'Shreay', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Dept. I of Internal Medicine, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Furman', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}]",Haematologica,['10.3324/haematol.2019.238808']
736,31517591,Clinical outcome measures in SPMS trials: An analysis of the IMPACT and ASCEND original trial data sets.,"BACKGROUND


Still too little is known about the natural history of clinical outcome measures beyond the Expanded Disability Status Scale (EDSS), such as the timed 25-foot walk (T25FW) and nine-hole peg test (9HPT) in secondary progressive multiple sclerosis (SPMS).
OBJECTIVE


To describe progression on the EDSS, T25FW, 9HPT, and their combinations. To investigate the association of the baseline characteristics age, sex, EDSS, T25FW, gadolinium-enhancing lesions, and relapse activity with EDSS and T25FW progression.
METHODS


Using original trial data from the placebo arms of the IMPACT and ASCEND randomized controlled trials, we describe disability progression (with and without 3- or 6-month confirmation). We investigated the association of selected baseline characteristics with EDSS and T25FW progression over 2 years using binary logistic regression.
RESULTS


T25FW was the single outcome measure with the largest proportion of patients progressing, followed by EDSS and 9HPT. EDSS and T25FW at baseline were associated with EDSS and T25FW progression in both data sets. Age and relapse activity were only mild and inconsistent predictors, while sex and gadolinium enhancement at baseline did not predict disability progression in either data set.
CONCLUSION


Our analyses inform the selection of primary outcome measures as well as inclusion criteria for clinical trials in SPMS.",2020,"RESULTS


T25FW was the single outcome measure with the largest proportion of patients progressing, followed by EDSS and 9HPT.",[],"['placebo', 'IMPACT and ASCEND', 'timed 25-foot walk (T25FW) and nine-hole peg test (9HPT']","['disability progression', 'Age and relapse activity', 'EDSS and T25FW progression']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test (assessment scale)'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.0690436,"RESULTS


T25FW was the single outcome measure with the largest proportion of patients progressing, followed by EDSS and 9HPT.","[{'ForeName': 'Marcus W', 'Initials': 'MW', 'LastName': 'Koch', 'Affiliation': 'Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada/Department of Community Health Sciences, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Jop', 'Initials': 'J', 'LastName': 'Mostert', 'Affiliation': 'Department of Neurology, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Uitdehaag', 'Affiliation': 'Department of Neurology, MS Center Amsterdam, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, The University of Alabama at Birmingham, Birmingham, AL, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519876701']
737,32436173,Evaluation of biochemical and clinical effects of hyaluronic acid on non-surgical periodontal treatment: a randomized controlled trial.,"BACKGROUND


Recent studies reported that hyaluronic acid (HA) has anti-inflammatory, anti-edematous, and anti-bacterial activities in dentistry, particularly in gingival disorders caused by subgingival plaque microorganisms.
AIMS


This study aimed to evaluate the early term effects of HA as an adjunct to scaling and root planing (SRP) on clinical parameters, periodontal inflamed surface area (PISA), and adenosine deaminase (ADA), catalase (CAT), and glutathione (GSH) levels in gingival crevicular fluid (GCF) in periodontitis.
METHODS


A total of 24 periodontitis patients per group were included in this randomized-controlled study. The study population was divided into four groups: in Group 1: SRP+ saline; in Group 2: SRP + HA gel; in Group 3: SRP+ HA mouth rinse; and in Group 4: SRP + HA mouth rinse + HA gingival gel were applied. At baseline and week 4, clinical parameters and PISA were calculated. Also, biochemicals' (ADA, CAT, and GSH) levels were determined by spectrophotometric analysis.
RESULTS


There was a statistically significant improvement in clinical parameters and PISA in all four groups in control sessions (p < 0.05). There was a significant decrease in ADA in GCF and significant increases in CAT and GSH levels after SRP (p < 0.05) in all four groups. The groups that were administered only gel (2nd and 4th) were different from other groups in terms of ADA, CAT, and GSH levels at 1st week (p < 0.05).
CONCLUSION


HA application as an adjunct to SRP did not affect the clinical results, although, in the control sessions following the application, the results were favorable for the biochemical data in gel-applied groups.
TRIAL REGISTRATION


ClinicalTrials.gov.tr (NCT03754010).",2020,There was a statistically significant improvement in clinical parameters and PISA in all four groups in control sessions (p < 0.05).,['24 periodontitis patients per group'],"['SRP+ saline', 'hyaluronic acid (HA', 'SRP\u2009+\u2009HA mouth rinse + HA gingival gel', 'HA', 'scaling and root planing (SRP', 'hyaluronic acid', 'SRP+ HA mouth rinse', 'SRP\u2009+\u2009HA gel']","[""biochemicals' (ADA, CAT, and GSH) levels"", 'clinical parameters, periodontal inflamed surface area (PISA), and adenosine deaminase (ADA), catalase (CAT), and glutathione (GSH) levels in gingival crevicular fluid (GCF', 'clinical parameters and PISA', 'CAT and GSH levels', 'ADA in GCF', 'ADA, CAT, and GSH levels']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C1276322', 'cui_str': 'Gingival gel'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}]",24.0,0.0471752,There was a statistically significant improvement in clinical parameters and PISA in all four groups in control sessions (p < 0.05).,"[{'ForeName': 'Hacer Sahin', 'Initials': 'HS', 'LastName': 'Aydinyurt', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Van Yuzuncu Yil University, Campus, 65080, Van, Turkey. hacersahinay@gmail.com.tr.'}, {'ForeName': 'Damla', 'Initials': 'D', 'LastName': 'Akbal', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Van Yuzuncu Yil University, Campus, 65080, Van, Turkey.'}, {'ForeName': 'Dicle', 'Initials': 'D', 'LastName': 'Altindal', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Van Yuzuncu Yil University, Campus, 65080, Van, Turkey.'}, {'ForeName': 'Alihan', 'Initials': 'A', 'LastName': 'Bozoglan', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Firat University, Elazig, Turkey.'}, {'ForeName': 'Abdullah Seckin', 'Initials': 'AS', 'LastName': 'Ertugrul', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Izmir Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Halit', 'Initials': 'H', 'LastName': 'Demir', 'Affiliation': 'Faculty of Art and Science, Department of Chemistry, Van Yuzuncu Yil University, Van, Turkey.'}]",Irish journal of medical science,['10.1007/s11845-020-02230-6']
738,32071913,Effects of Subsequent Systemic Anticancer Medication Following First-Line Lenvatinib: A Post Hoc Responder Analysis from the Phase 3 REFLECT Study in Unresectable Hepatocellular Carcinoma.,"Introduction


Understanding the relationship between subsequent-line therapies and overall survival (OS) is important for maximizing OS for patients with hepatocellular carcinoma.
Objective


In this post hoc analysis, we investigated OS in lenvatinib- and sorafenib-treated patients from the REFLECT study, who then received subsequent anticancer medication during the survival follow-up period.
Methods


The follow-up period commenced at the first off-treatment visit after stopping the study medication and continued until study termination, withdrawal of consent, or death. OS and objective response rate were calculated for patients who did or did not receive poststudy anticancer medication for both treatment arms, as well as for the overall cohort. We investigated the subset of patients who responded to first-line treatment and subsequently received anticancer medication.
Results


The OS for patients initially randomized to first-line lenvatinib (versus first-line sorafenib) and who then received any subsequent anticancer medication was 20.8 vs. 17.0 months (hazard ratio [HR] 0.87; 95% CI 0.67-1.14). The OS for patients who initially received first-line lenvatinib (versus first-line sorafenib) and who did not receive any subsequent anticancer medication was 11.5 vs. 9.1 months (HR 0.90; 95% CI 0.75-1.09). Responders to first-line lenvatinib who received subsequent medication had a median OS of 25.7 months (95% CI 18.5-34.6); responders to first line-sorafenib who received subsequent medication had a median OS of 22.3 months (95% CI 14.6-not evaluable).
Conclusions


In this post hoc analysis of all patients in the REFLECT study who received subsequent anticancer medication, OS was increased compared with patients who did not receive any subsequent anticancer medication. In a subset analysis of responders who had received subsequent anticancer medication, use of first-line lenvatinib led to a slightly longer median OS; more research is needed on the benefits of using first-line lenvatinib compared with sorafenib.",2020,"OS and objective response rate were calculated for patients who did or did not receive poststudy anticancer medication for both treatment arms, as well as for the overall cohort.","['Unresectable Hepatocellular Carcinoma', 'First-Line Lenvatinib', 'patients with hepatocellular carcinoma']","['sorafenib', 'anticancer medication', 'Subsequent Systemic Anticancer Medication']","['overall survival (OS', 'OS and objective response rate']","[{'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",,0.0458477,"OS and objective response rate were calculated for patients who did or did not receive poststudy anticancer medication for both treatment arms, as well as for the overall cohort.","[{'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Alsina', 'Affiliation': 'aTransplant and Specialty Services, Tampa General Hospital, Tampa, Florida, USA.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'bDepartment of Medicine, Kindai University, Osaka, Japan.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Vogel', 'Affiliation': 'cDepartment of Gastroenterology, Hepatology, and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'dDepartment of Medical Oncology, National Taiwan University Hospital, and National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Won Young', 'Initials': 'WY', 'LastName': 'Tak', 'Affiliation': 'eDepartment of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Baek-Yeol', 'Initials': 'BY', 'LastName': 'Ryoo', 'Affiliation': 'fDepartment of Oncology, Asan Medical Center, and University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Thomas R Jeffry', 'Initials': 'TRJ', 'LastName': 'Evans', 'Affiliation': 'gInstitute of Cancer Sciences, Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'López López', 'Affiliation': 'hOncology Service, Marqués de Valdecilla University Hospital, IDIVAL, Santander, Spain.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Daniele', 'Affiliation': 'iDepartment of Oncology, Azienda Ospedaliera G. Rummo, Benevento, Italy and Ospedale del Mare, Naples, Italy.'}, {'ForeName': 'Soamnauth', 'Initials': 'S', 'LastName': 'Misir', 'Affiliation': 'jFormerly of Eisai Inc., Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ren', 'Affiliation': 'kEisai Inc., Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Namiki', 'Initials': 'N', 'LastName': 'Izumi', 'Affiliation': 'lDepartment of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Musashino, Tokyo, Japan.'}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'mPLA Cancer Center, Nanjing Bayi Hospital, Nanjing, Jiangsu, China.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'nGeffen School of Medicine, Department of Medicine, UCLA Medical Center, Santa Monica, California, USA.'}]",Liver cancer,['10.1159/000504624']
739,31509451,Secondary Outcomes from a Randomized Controlled Trial of Yoga for Veterans with Chronic Low-Back Pain.,"Chronic low-back pain (cLBP) is a prevalent condition, and rates are higher among military veterans. cLBP is a persistent condition, and treatment options have either modest effects or a significant risk of side-effects, which has led to recent efforts to explore mind-body intervention options and reduce opioid medication use. Prior studies of yoga for cLBP in community samples, and the main results of a recent trial with military veterans, indicate that yoga can reduce back-related disability and pain intensity. Secondary outcomes from the trial of yoga with military veterans are presented here. In the study, 150 military veterans (Veterans Administration patients) with cLBP were randomized to either yoga or a delayed-treatment group receiving usual care between 2013 and 2015. Assessments occurred at baseline, 6 weeks, 12 weeks, and 6 months. Intent-to-treat analyses were conducted. Yoga classes lasting 60 minutes each were offered twice weekly for 12 weeks. Yoga sessions consisted of physical postures, movement, focused attention, and breathing techniques. Home practice guided by a manual was strongly recommended. The primary outcome measure was Roland-Morris Disability Questionnaire scores after 12 weeks. Secondary outcomes included pain intensity, pain interference, depression, fatigue, quality of life, self-efficacy, and medication usage. Yoga participants improved more than delayed-treatment participants on pain interference, fatigue, quality of life, and self-efficacy at 12 weeks and/or 6 months. Yoga participants had greater improvements across a number of important secondary health outcomes compared to controls. Benefits emerged despite some veterans facing challenges with attending yoga sessions in person. The findings support wider implementation of yoga programs for veterans, with attention to increasing accessibility of yoga programs in this population.",2020,"Secondary outcomes included pain intensity, pain interference, depression, fatigue, quality of life, self-efficacy, and medication usage.","['military veterans', 'Veterans with Chronic Low-Back Pain', '150 military veterans (Veterans Administration patients) with cLBP']","['cLBP', 'yoga or a delayed-treatment group receiving usual care', 'physical postures, movement, focused attention, and breathing techniques']","['Chronic low-back pain (cLBP', 'pain interference, fatigue, quality of life, and self-efficacy', 'Roland-Morris Disability Questionnaire scores', 'number of important secondary health outcomes', 'pain intensity, pain interference, depression, fatigue, quality of life, self-efficacy, and medication usage']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0589098', 'cui_str': 'Focused attention, function (observable entity)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}]",150.0,0.075649,"Secondary outcomes included pain intensity, pain interference, depression, fatigue, quality of life, self-efficacy, and medication usage.","[{'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Groessl', 'Affiliation': 'VA San Diego Healthcare System; and Department of Family Medicine and Public Health, University of California San Diego.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'VA San Diego Healthcare System; and Department of Family Medicine and Public Health, University of California San Diego.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Schmalzl', 'Affiliation': 'College of Science and Integrative Health, Southern California University of Health Sciences, Whittier; and Department of Family Medicine and Public Health, University of California San Diego.'}, {'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'Chang', 'Affiliation': 'VA San Diego Healthcare System; and Department of Orthopedic Surgery, University of California San Diego.'}, {'ForeName': 'Adhana', 'Initials': 'A', 'LastName': 'McCarthy', 'Affiliation': 'SDSU/UC San Diego Joint Doctoral Program in Public Health, La Jolla, Calif.; and Army Medical Department Center and Schools, San Antonio.'}, {'ForeName': 'Won I', 'Initials': 'WI', 'LastName': 'Chun', 'Affiliation': 'VA San Diego Healthcare System; and Department of Orthopedic Surgery, University of California San Diego.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Sinclair', 'Affiliation': 'VA San Diego Healthcare System.'}, {'ForeName': 'Jill E', 'Initials': 'JE', 'LastName': 'Bormann', 'Affiliation': 'Hahn School of Nursing & Health Sciences, University of San Diego; and VA Center of Excellence in Stress and Mental Health, San Diego.'}]",International journal of yoga therapy,['10.17761/2020-D-19-00036']
740,32436641,"Ultrarapid lispro lowers postprandial glucose and more closely matches normal physiological glucose response compared to other rapid insulin analogues: A phase 1 randomized, crossover study.","AIMS


To compare the pharmacokinetic (PK) and glucodynamic (GD) characteristics of ultra rapid lispro (URLi; Eli Lilly and Company, Indianapolis, Indiana), Fiasp® (Novo Nordisk, Bagsvaerd, Denmark), Humalog® (Eli Lilly and Company) and NovoRapid® (Novo Nordisk), in patients with type 1 diabetes (T1D).
MATERIALS AND METHODS


This was a randomized, double-blind, four-period, crossover study, conducted in 68 patients with T1D. Patients received the same individualized subcutaneous dose of each study drug immediately prior to a liquid test meal. For comparison, 12 healthy subjects received the same test meal.
RESULTS


URLi had a significantly faster insulin absorption compared to the other insulins tested. Early half-maximal drug concentration was reached 13 minutes after administration of URLi, which was 6 minutes faster than Fiasp, 13 minutes faster than Humalog, and 14 minutes faster than NovoRapid (all P <0.0001). Early insulin exposure was significantly greater and late insulin exposure was reduced after URLi compared to the other insulins. URLi achieved the greatest numerical reduction in postprandial glucose (PPG) at 2 hours post-meal (7 mg/dL vs Fiasp) and was significantly different from Humalog (21 mg/dL) and Novo Rapid (29 mg/dL). Additionally, glucose excursions over the first 3 hours post-meal with URLi were comparable to those in healthy subjects.
CONCLUSIONS


URLi demonstrated the fastest insulin absorption and the greatest numeric PPG-lowering effect compared to the other insulins tested. URLi more closely matched the early physiological glucose control observed in healthy subjects.",2020,URLi achieved the greatest numerical reduction in PPG at 2 hours post-meal (7 mg/dL vs Fiasp) and significant differences to Humalog (21 mg/dL) and Novo Rapid (29 mg/dL).,"['68 patients with T1D. Patients', 'patients with type 1 diabetes (T1D', '12 healthy subjects', 'healthy subjects']","['URLi', 'pharmacokinetics (PK) and glucocodynamics (GD) of URLi, Fiasp®, Humalog®, and NovoRapid®', 'Ultra rapid lispro (URLi']","['Ultra Rapid Lispro Lowers Postprandial Glucose and More Closely Matches Normal Physiological Glucose Response', 'insulin absorption', 'maximal drug concentration', 'glucose excursions', 'postprandial glucose (PPG) control', 'late insulin exposure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4529885', 'cui_str': 'Fiasp'}, {'cui': 'C0528249', 'cui_str': 'Humalog'}, {'cui': 'C0939412', 'cui_str': 'NovoRapid'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",68.0,0.0670366,URLi achieved the greatest numerical reduction in PPG at 2 hours post-meal (7 mg/dL vs Fiasp) and significant differences to Humalog (21 mg/dL) and Novo Rapid (29 mg/dL).,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Linnebjerg', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Coutant', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'LaBell', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zijlstra', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kapitza', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Bue-Valleskey', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Qianyi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Dellva', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Leohr', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14094']
741,31500679,"LSD acutely impairs working memory, executive functions, and cognitive flexibility, but not risk-based decision-making.","BACKGROUND


Psychiatric and neurodegenerative illnesses are characterized by cognitive impairments, in particular deficits in working memory, decision-making, and executive functions including cognitive flexibility. However, the neuropharmacology of these cognitive functions is poorly understood. The serotonin (5-HT) 2A receptor might be a promising candidate for the modulation of cognitive processes. However, pharmacological studies investigating the role of this receptor system in humans are rare. Recent evidence demonstrates that the effects of Lysergic acid diethylamide (LSD) are mediated via agonistic action at the 5-HT2A receptor. Yet, the effects of LSD on specific cognitive domains using standardized neuropsychological test have not been studied.
METHODS


We examined the acute effects of LSD (100 µg) alone and in combination with the 5-HT2A antagonist ketanserin (40 mg) on cognition, employing a double-blind, randomized, placebo-controlled, within-subject design in 25 healthy participants. Executive functions, cognitive flexibility, spatial working memory, and risk-based decision-making were examined by the Intra/Extra-Dimensional shift task (IED), Spatial Working Memory task (SWM), and Cambridge Gambling Task (CGT) of the Cambridge Neuropsychological Test Automated Battery.
RESULTS


Compared to placebo, LSD significantly impaired executive functions, cognitive flexibility, and working memory on the IED and SWM, but did not influence the quality of decision-making and risk taking on the CGT. Pretreatment with the 5-HT2A antagonist ketanserin normalized all LSD-induced cognitive deficits.
CONCLUSIONS


The present findings highlight the role of the 5-HT2A receptor system in executive functions and working memory and suggest that specific 5-HT2A antagonists may be relevant for improving cognitive dysfunctions in psychiatric disorders.",2020,"Compared to placebo, LSD significantly impaired executive functions, cognitive flexibility, and working memory on the IED and SWM, but did not influence the quality of decision-making and risk taking on the CGT.",['25 healthy participants'],"['LSD', 'LSD (100 µg) alone and in combination with the 5-HT2A antagonist ketanserin', 'placebo', 'placebo, LSD', 'Lysergic acid diethylamide (LSD', '5-HT2A antagonist ketanserin']","['executive functions, cognitive flexibility, and working memory on the IED and SWM', 'quality of decision-making and risk taking on the CGT', 'Executive functions, cognitive flexibility, spatial working memory, and risk-based decision-making', 'Intra/Extra-Dimensional shift task (IED), Spatial Working Memory task (SWM), and Cambridge Gambling Task (CGT) of the Cambridge Neuropsychological Test Automated Battery', 'working memory, executive functions, and cognitive flexibility']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2936524', 'cui_str': '5-HT2A Antagonist'}, {'cui': 'C0022616', 'cui_str': 'Ketanserin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C4505411', 'cui_str': 'Cambridge Neuropsychological Test Automated Battery'}]",25.0,0.0498576,"Compared to placebo, LSD significantly impaired executive functions, cognitive flexibility, and working memory on the IED and SWM, but did not influence the quality of decision-making and risk taking on the CGT.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pokorny', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Duerler', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Franz X', 'Initials': 'FX', 'LastName': 'Vollenweider', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Katrin H', 'Initials': 'KH', 'LastName': 'Preller', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}]",Psychological medicine,['10.1017/S0033291719002393']
742,32106135,CORR Insights®: Are There Differences in Micromotion on Radiostereometric Analysis Between Bicruciate- and Cruciate-retaining Designs in TKA? A Randomized Controlled Trial.,,2020,,[],['CORR Insights®'],[],[],[],[],,0.150622,,"[{'ForeName': 'Rémy S', 'Initials': 'RS', 'LastName': 'Nizard', 'Affiliation': 'R. S. Nizard, Professor of Orthopaedic Surgery, Hospital Lariboisiere, Orthopedique et Trumatologique, Paris, France.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001173']
743,31513079,"""Impact of HIV Self-Test Distribution to Male Partners of ANC Clients: Results of a Randomized Controlled Trial in Kenya: Erratum"".",,2019,,['Male Partners of ANC Clients'],[],[],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]",[],[],,0.0944046,,[],Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002152']
744,32103358,Pre-post analysis of a social capital-based exercise adherence intervention for breast cancer survivors with moderate fatigue: a randomized controlled trial.,"PURPOSE


This study assessed the effectiveness of the Better Life After Cancer: Energy, Strength, and Support (BLESS) program, a 12-week social capital-based exercise adherence program for breast cancer survivors (BCS), regarding cancer-related fatigue (CRF), quality of life (QOL), physical activity, and psychosocial characteristics.
METHODS


Forty-eight BCS with moderate or high (≥ 4) CRF participated in this randomized control trial (intervention group n = 23, control group n = 25). The intervention group participated in small group sessions to activate social capital while targeting CRF in supervised physical exercises supplemented by home-based physical exercises. The control group was only given written information on exercise. A questionnaire was used to assess CRF, QOL, physical activity, depression, anxiety, sleep quality, and social capital.
RESULTS


The majority of participants had undergone surgery less than 2 years ago. After participating in BLESS, the CRF behavioral/severity domain significantly decreased (t = 2.642, p = 0.011) and physical activity significantly increased (t = - 2.049, p = 0.046) in the intervention group, in comparison with the control group; there were no significant post-intervention differences in the control group. Both groups showed improvements in sleep quality, depression, anxiety, and QOL.
CONCLUSION


The BLESS program decreased behavioral/severity in the CRF and increased physical activity after 12 weeks among BCS. Future research needs to evaluate whether the promising results on physical activity and behavioral fatigue observed in the short term will persist over time. Also, longer-term effects should be examined.",2020,"After participating in BLESS, the CRF behavioral/severity domain significantly decreased (t = 2.642, p = 0.011) and physical activity significantly increased (t = - 2.049, p = 0.046) in the intervention group, in comparison with the control group; there were no significant post-intervention differences in the control group.","['breast cancer survivors with moderate fatigue', 'breast cancer survivors (BCS', 'Forty-eight BCS with moderate or high (≥\u20094']","['CRF', 'Strength, and Support (BLESS) program, a 12-week social capital-based exercise adherence program', 'social capital-based exercise adherence intervention', 'small group sessions to activate social capital while targeting CRF in supervised physical exercises supplemented by home-based physical exercises']","['physical activity', 'physical activity and behavioral fatigue', 'sleep quality, depression, anxiety, and QOL', 'cancer-related fatigue (CRF), quality of life (QOL), physical activity, and psychosocial characteristics', 'CRF behavioral/severity domain', 'behavioral/severity', 'CRF, QOL, physical activity, depression, anxiety, sleep quality, and social capital']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1510639', 'cui_str': 'Social Capital'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0034380'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1510639', 'cui_str': 'Social Capital'}]",48.0,0.0337544,"After participating in BLESS, the CRF behavioral/severity domain significantly decreased (t = 2.642, p = 0.011) and physical activity significantly increased (t = - 2.049, p = 0.046) in the intervention group, in comparison with the control group; there were no significant post-intervention differences in the control group.","[{'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Mo-Im Kim Nursing Research Institute, College of Nursing, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Yun Hee', 'Initials': 'YH', 'LastName': 'Ko', 'Affiliation': 'College of Nursing, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Yoonkyung', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Sports Industry Studies, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Min Jae', 'Initials': 'MJ', 'LastName': 'Kang', 'Affiliation': 'Department of Sports Industry Studies, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Hyojin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Sung Hae', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, College of Health. Welfare and Education, Tongmyong University, Busan, Korea.'}, {'ForeName': 'Justin Y', 'Initials': 'JY', 'LastName': 'Jeon', 'Affiliation': 'Department of Sports Industry Studies, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Young Up', 'Initials': 'YU', 'LastName': 'Cho', 'Affiliation': 'Formerly affiliated with Yonsei University Health System, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Gihong', 'Initials': 'G', 'LastName': 'Yi', 'Affiliation': 'Department of Sociology, Hallym University, 1, Hallymdaehak-gil, Chuncheon-si, Gangwon-do, 24252, Korea.'}, {'ForeName': 'Jeehee', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'College of Nursing, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea. hjihee1225@hanmail.net.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05363-7']
745,32077305,Join the Commune: A Controlled Study of Social Branding Influencers to Decrease Smoking Among Young Adult Hipsters.,"PURPOSE


To evaluate the impact of a Social Branding intervention in bars and nightclubs on smoking behavior.
DESIGN


Quasi-experimental controlled study.
SETTING


Bars and nightclubs in San Diego and San Francisco (intervention) and Los Angeles (control).
PARTICIPANTS


""Hipster"" young adults (age 18-26) attending bars and nightclubs.
INTERVENTION


Anti-tobacco messages delivered through monthly anti-tobacco music/social events, opinion leaders, original art, direct mail, promotional activities, and online media.
MEASURES


A total of 7240 surveys were collected in 3 cities using randomized time location sampling at baseline (2012-2013) and follow-up (2015-2016); data were analyzed in 2018. The primary outcome was current smoking.
ANALYSIS


Multivariable logistic regression assessed correlates of smoking, adjusting for covariates including electronic cigarette use; differences between cities were evaluated using location-by-time interactions.
RESULTS


Smoking in San Francisco decreased at a significantly faster rate (51.1%-44.1%) than Los Angeles (45.2%-44.5%) ( P  = .034). Smoking in San Diego (mean: 39.6%) was significantly lower than Los Angeles (44.8%,  P  < .001) at both time points with no difference in rate of change. Brand recall was not associated with smoking behavior, but recall was associated with anti-tobacco attitudes that were associated with smoking.
CONCLUSION


This is the first controlled study of Social Branding interventions. Intervention implementation was accompanied by decreases in smoking (San Francisco) and sustained lower smoking (San Diego) among young adult bar patrons over 3 years.",2020,Intervention implementation was accompanied by decreases in smoking (San Francisco) and sustained lower smoking (San Diego) among young adult bar patrons over 3 years.,"['Young Adult Hipsters', 'Hipster"" young adults (age 18-26) attending bars and nightclubs', 'A total of 7240 surveys were collected in 3 cities using randomized time location sampling at baseline (2012-2013) and follow-up (2015-2016); data were analyzed in 2018', 'Join the Commune', 'Bars and nightclubs in San Diego and San Francisco (intervention) and Los Angeles (control']","['Social Branding intervention', 'Anti-tobacco messages delivered through monthly anti-tobacco music/social events, opinion leaders, original art, direct mail, promotional activities, and online media']","['smoking (San Francisco) and sustained lower smoking (San Diego', 'faster rate', 'current smoking', 'Smoking in San Francisco']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0442567', 'cui_str': 'Nightclub (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0871010', 'cui_str': 'Opinions'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]",7240.0,0.0214507,Intervention implementation was accompanied by decreases in smoking (San Francisco) and sustained lower smoking (San Diego) among young adult bar patrons over 3 years.,"[{'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Ling', 'Affiliation': 'Division of General Internal Medicine and Center for Tobacco Control Research and Education, Department of Medicine, 8785University of California, San Francisco, CA, USA.'}, {'ForeName': 'Nadra E', 'Initials': 'NE', 'LastName': 'Lisha', 'Affiliation': 'Division of General Internal Medicine and Center for Tobacco Control Research and Education, Department of Medicine, 8785University of California, San Francisco, CA, USA.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Center for AIDS Prevention Studies, 8785University of California, San Francisco, CA, USA.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Jordan', 'Affiliation': 'Rescue Agency, San Diego, CA, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117120904917']
746,32028078,Assessing gait efficacy in older adults: An analysis using item response theory.,"BACKGROUND


Assessing confidence in walking in older adults is important, as mobility is a critical aspect of independence and function, and self-report provides complementary information to performance-based measures. The modified Gait Efficacy Scale (mGES) is a self-report measure used to examine confidence in walking.
RESEARCH QUESTION


What are the psychometric properties of the mGES at the item level? Are there opportunities for improvement?
METHODS


We performed a secondary analysis of baseline data from a cluster randomized trial of 424 community-dwelling older adults and reliability data from 123 participants. We fitted a graded response model to dissect the mGES to the item and individual response level and examined opportunities to improve and possible shorten the mGES. We examined psychometric characteristics such as internal consistency, test-retest reliability and construct validity with respect to other relevant measures.
RESULTS


Mobility tasks such as navigating stairs and curbs with separate items for going up and down largely provide the same information on confidence, with downward direction providing slightly more. It may be reasonable to consider removal of walking 1/2 mile, stepping down and/or stair tasks with railings items due to little or duplicate information contributed compared to other items. The shortened scales proposed by removing the above items had similar psychometric properties to mGES.
SIGNIFICANCE


The mGES has good psychometric properties, but can be potentially shortened to substantially reduce responder burden. The upward direction curb and stairs items can be removed to result in a 7-item scale with virtually no loss of desirable psychometrics. An alternative 3-item version, level surface walking, stepping down curb and climbing up stairs without a railing items, entails only a minimal loss in psychometric properties.",2020,"The shortened scales proposed by removing the above items had similar psychometric properties to mGES.
","['older adults', '424 community-dwelling older adults and reliability data from 123 participants']",[],"['gait efficacy', 'modified Gait Efficacy Scale (mGES']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",[],"[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}]",424.0,0.0239234,"The shortened scales proposed by removing the above items had similar psychometric properties to mGES.
","[{'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, 3471 Fifth Avenue, Suite 500, Pittsburgh, PA 15213, USA; Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: ksp9@pitt.edu.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'VanSwearingen', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Bridgeside Point 1, 100 Technology Drive, Suite 210, Pittsburgh, PA 15219, USA. Electronic address: jessievs@pitt.edu.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Shuman', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Bridgeside Point 1, 100 Technology Drive, Suite 210, Pittsburgh, PA 15219, USA. Electronic address: vls40@pitt.edu.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Brach', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Bridgeside Point 1, 100 Technology Drive, Suite 210, Pittsburgh, PA 15219, USA. Electronic address: jbrach@pitt.edu.'}]",Gait & posture,['10.1016/j.gaitpost.2020.01.028']
747,32435929,Effectiveness of the clinical decision support tool ESR eGUIDE for teaching medical students the appropriate selection of imaging tests: randomized cross-over evaluation.,"OBJECTIVES


To evaluate ESR eGUIDE-the European Society of Radiology (ESR) e-Learning tool for appropriate use of diagnostic imaging modalities-for learning purposes in different clinical scenarios.
METHODS


This anonymized evaluation was performed after approval of ESR Education on Demand leadership. Forty clinical scenarios were developed in which at least one imaging modality was clinically most appropriate, and the scenarios were divided into sets 1 and 2. These sets were provided to medical students randomly assigned to group A or B to select the most appropriate imaging test for each scenario. Statistical comparisons were made within and across groups.
RESULTS


Overall, 40 medical students participated, and 31 medical students (78%) answered both sets. The number of correctly chosen imaging methods per set in these 31 paired samples was significantly higher when answered with versus without use of ESR eGUIDE (13.7 ± 2.6 questions vs. 12.1 ± 3.2, p = 0.012). Among the students in group A, who first answered set 1 without ESR eGUIDE (11.1 ± 3.2), there was significant improvement when set 2 was answered with ESR eGUIDE (14.3 ± 2.5, p = 0.013). The number of correct answers in group B did not drop when set 2 was answered without ESR eGUIDE (12.4 ± 2.6) after having answered set 1 first with ESR eGUIDE (13.0 ± 2.7, p = 0.66).
CONCLUSION


The clinical decision support tool ESR eGUIDE is suitable for training medical students in choosing the best radiological imaging modality in typical scenarios, and its use in teaching radiology can thus be recommended.
KEY POINTS


• ESR eGUIDE improved the number of appropriately selected imaging modalities among medical students. • This improvement was also seen in the group of students which first selected imaging tests without ESR eGUIDE. • In the student group which used ESR eGUIDE first, appropriate selection remained stable even without the teaching tool.",2020,"The clinical decision support tool ESR eGUIDE is suitable for training medical students in choosing the best radiological imaging modality in typical scenarios, and its use in teaching radiology can thus be recommended.
","['40 medical students participated, and 31 medical students (78%) answered both sets', 'teaching medical students']",[],['number of correct answers'],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0039401', 'cui_str': 'Education'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",,0.0195978,"The clinical decision support tool ESR eGUIDE is suitable for training medical students in choosing the best radiological imaging modality in typical scenarios, and its use in teaching radiology can thus be recommended.
","[{'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Diekhoff', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Kainberger', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Oleaga', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dewey', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany. marc.dewey@charite.de.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}]",European radiology,['10.1007/s00330-020-06942-2']
748,14765721,Minimal intervention programs for weight loss in heart transplant candidates: a preliminary examination.,"CONTEXT


Overweight can be a contraindication for cardiac transplantation, and empirical findings suggest that obesity may pose serious posttransplant health risks that can increase morbidity and mortality.
OBJECTIVE


This study assessed the relative effectiveness of 2 minimal intervention programs to assist weight loss in heart transplant candidates.
DESIGN


A randomized trial was employed to assess changes in body weight.
SETTING


A large, tertiary care hospital in a Southern locale.
PATIENTS


Forty-three heart transplant candidates (74% men, 79% married, 86% white), with a mean pretreatment body mass index of 32.4 (SD = 4.4).
INTERVENTIONS


Patients were randomly assigned to a bibliotherapy weight-loss program or a bibliotherapy plus telephone contact weight-loss program.
MAIN OUTCOME MEASURES


Change in body weight over 3 months and return rate of measures of program adherence (3-day food diaries and self-monitoring postcards).
RESULTS


An intent-to-treat analysis showed a significant weight loss at posttreatment for the sample as a whole. Within-group analyses indicated that a significant weight change (P < .05) in the telephone contact group (mean [SD] = -2.76 [4.96] kg) but not the bibliotherapy-only group (mean [SD] = -1.02 [2.97] kg). Participants in the telephone contact group returned more 3-day food diaries and self-monitoring postcards, with pounds lost significantly correlated with the number of completed self-monitoring postcards. These findings suggest that a minimal intervention program involving information plus limited professional contact may represent a viable approach to assisting overweight transplant candidates in weight management.",2003,Within-group analyses indicated that a significant weight change (P < .05) in the telephone contact group (mean [SD] = -2.76 [4.96] kg) but not the bibliotherapy-only group (mean [SD] = -1.02 [2.97] kg).,"['heart transplant candidates', 'A large, tertiary care hospital in a Southern locale', 'Forty-three heart transplant candidates (74% men, 79% married, 86% white), with a mean pretreatment body mass index of 32.4 (SD = 4.4']","['bibliotherapy weight-loss program or a bibliotherapy plus telephone contact weight-loss program', 'Minimal intervention programs']","['body weight over 3 months and return rate of measures of program adherence (3-day food diaries and self-monitoring postcards', 'weight loss', 'weight change', 'number of completed self-monitoring postcards', '3-day food diaries and self-monitoring postcards']","[{'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517709', 'cui_str': '32.4 (qualifier value)'}, {'cui': 'C4517761', 'cui_str': '4.4'}]","[{'cui': 'C0005365', 'cui_str': 'Bibliotherapy'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C2717852', 'cui_str': 'Postcard'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",,0.031162,Within-group analyses indicated that a significant weight change (P < .05) in the telephone contact group (mean [SD] = -2.76 [4.96] kg) but not the bibliotherapy-only group (mean [SD] = -1.02 [2.97] kg).,"[{'ForeName': 'Tricia L', 'Initials': 'TL', 'LastName': 'Park', 'Affiliation': 'Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Perri', 'Affiliation': ''}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Rodrigue', 'Affiliation': ''}]","Progress in transplantation (Aliso Viejo, Calif.)",[]
749,31494820,"Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I-a randomized, placebo-controlled, double-blind, Asian-Pacific trial.","OBJECTIVE


To evaluate the safety and efficacy of Cerebrolysin as an add-on therapy to local standard treatment protocol in patients after moderate-to-severe traumatic brain injury.
METHODS


The patients received the study medication in addition to standard care (50 mL of Cerebrolysin or physiological saline solution daily for 10 days, followed by two additional treatment cycles with 10 mL daily for 10 days) in a prospective, randomized, double-blind, placebo-controlled, parallel-group, multi-centre phase IIIb/IV trial. The primary endpoint was a multidimensional ensemble of 14 outcome scales pooled to be analyzed by means of the multivariate, correlation-sensitive Wei-Lachin procedure.
RESULTS


In 46 enrolled TBI patients (Cerebrolysin 22, placebo 24), three single outcomes showed stand-alone statistically significant superiority of Cerebrolysin [Stroop Word/Dots Interference (p = 0.0415, Mann-Whitney(MW) = 0.6816, 95% CI 0.51-0.86); Color Trails Tests 1 and 2 (p = 0.0223/0.0170, MW = 0.72/0.73, 95% CI 0.53-0.90/0.54-0.91), both effect sizes lying above the benchmark for ""large"" superiority (MW > 0.71)]. While for the primary multivariate ensemble, statistical significance was just missed in the intention-to-treat population (p Wei-Lachin  < 0.1, MW combined  = 0.63, 95% CI 0.48-0.77, derived standardized mean difference (SMD) 0.45, 95% CI -0.07 to 1.04, derived OR 2.1, 95% CI 0.89-5.95), the per-protocol analysis showed a statistical significant superiority of Cerebrolysin (p Wei-Lachin  = 0.0240, MW combined  = 0.69, 95% CI 0.53 to 0.85, derived SMD 0.69, 95% CI 0.09 to 1.47, derived OR 3.2, 95% CI 1.16 to 12.8), with effect sizes of six single outcomes lying above the benchmark for ""large"" superiority. Safety aspects were comparable to placebo.
CONCLUSION


Our trial suggests beneficial effects of Cerebrolysin on outcome after TBI. Results should be confirmed by a larger RCT with a comparable multidimensional approach.",2020,"Safety aspects were comparable to placebo.
","['patients after moderate-to-severe traumatic brain injury', 'acute brain injury and neurorecovery']","['placebo', 'standard care (50\xa0mL of Cerebrolysin or physiological saline solution', 'Cerebrolysin']","['Safety and efficacy', 'safety and efficacy', 'multidimensional ensemble of 14 outcome scales pooled to be analyzed by means of the multivariate, correlation-sensitive Wei-Lachin procedure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0085742', 'cui_str': 'Injuries, Acute Brain'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0055108', 'cui_str': 'cerebrolysine'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0222045'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",46.0,0.740514,"Safety aspects were comparable to placebo.
","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Poon', 'Affiliation': 'Division of Neurosurgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong, China.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Matula', 'Affiliation': 'Department of Neurosurgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'P E', 'Initials': 'PE', 'LastName': 'Vos', 'Affiliation': 'Department of Neurology, Slingeland Hospital, Doetinchem, The Netherlands.'}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Muresanu', 'Affiliation': 'Department of Clinical Neurosciences, ""Iuliu Hatieganu"" University of Medicine and Pharmacy, Cluj-Napoca, Romania. dafinm@ssnn.ro.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'von Steinbüchel', 'Affiliation': 'Institute of Medical Psychology and Medical Sociology, University Medical Centre Göttingen, Göttingen, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'von Wild', 'Affiliation': ""Medical Faculty, Westphalia Wilhelm's University, Münster, Germany.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Hömberg', 'Affiliation': 'Department of Neurology, SRH Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, National Neuroscience Institute, Singapore, Singapore.'}, {'ForeName': 'T M C', 'Initials': 'TMC', 'LastName': 'Lee', 'Affiliation': 'State Key Laboratory of Brain and Cognitive Sciences and Laboratory of Neuropsychology, The University of Hong Kong, Pokfulam, Hong Kong, China.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Strilciuc', 'Affiliation': 'Department of Clinical Neurosciences, ""Iuliu Hatieganu"" University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Vester', 'Affiliation': 'Department of Biometry and Clinical Research, idv Data Analysis and Study Planning, Krailling, Germany.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-019-04053-5']
750,31538401,Pilot feasibility study of a home-based fall prevention exercise program (StandingTall) delivered through a tablet computer (iPad) in older people with dementia.,"OBJECTIVE


To assess the feasibility and safety of StandingTall-an individually tailored, progressive exercise program delivered through tablet computers-in community-dwelling older people with dementia.
METHODS


Fifteen community-dwelling older people with dementia (mean age = 83 ± 8 years; Montreal Cognitive Assessment 16 ± 5) received StandingTall for 12 weeks with caregiver assistance. Feasibility and safety were assessed using the System Usability Scale (SUS; scores = 0-100; a priori target >65), Physical Activity Enjoyment Scale (PACES-8; scores = 8-56), adherence (exercise minutes) and adverse events.
RESULTS


Mean SUS scores were 68 ± 21/69 ± 15 (participants/caregivers). The mean PACES-8 score was 44 ± 8. In week 2, week 7 and week 12, mean (bias-corrected and accelerated 95% CI) exercise minutes were 37 (25-51), 49 (30-69) and 65 (28-104), respectively. In week 12, five participants exercised >115 minutes. One participant fell while exercising, without sustained injury.
CONCLUSIONS


StandingTall had acceptable usability, scored well on enjoyment and was feasible for participants. These results provide support for further evaluation of StandingTall in a randomised controlled trial with falls as the primary outcome.",2020,"In week 2, week 7 and week 12, mean (bias-corrected and accelerated 95% CI) exercise minutes were 37 (25-51), 49 (30-69) and 65 (28-104), respectively.","['community-dwelling older people with dementia', 'older people with dementia', 'Fifteen community-dwelling older people with dementia (mean age\xa0=\xa083\xa0±\xa08\xa0years; Montreal Cognitive Assessment 16\xa0±\xa05) received']","['StandingTall for 12\xa0weeks with caregiver assistance', 'StandingTall-an individually tailored, progressive exercise program', 'home-based fall prevention exercise program (StandingTall) delivered through a tablet computer (iPad']","['System Usability Scale (SUS; scores', 'mean PACES-8 score', 'Mean SUS scores', 'Physical Activity Enjoyment Scale (PACES-8; scores\xa0=\xa08-56), adherence (exercise minutes) and adverse events', 'feasibility and safety', 'Feasibility and safety']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3496286'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}, {'cui': 'C4045980', 'cui_str': 'Tablet Computers'}]","[{'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",15.0,0.074222,"In week 2, week 7 and week 12, mean (bias-corrected and accelerated 95% CI) exercise minutes were 37 (25-51), 49 (30-69) and 65 (28-104), respectively.","[{'ForeName': 'Morag E', 'Initials': 'ME', 'LastName': 'Taylor', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Jacqueline C T', 'Initials': 'JCT', 'LastName': 'Close', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Lord', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Kurrle', 'Affiliation': 'Cognitive Decline Partnership Centre, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Lyndell', 'Initials': 'L', 'LastName': 'Webster', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Savage', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Delbaere', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, UNSW, Sydney, NSW, Australia.'}]",Australasian journal on ageing,['10.1111/ajag.12717']
751,28470086,A Reexamination of Child Problem Behaviors as Measured by ECBI: Factor Structure and Measurement Invariance Across Two Parent Training Interventions.,"The Eyberg Child Behavior Inventory (ECBI) is a widely used instrument that assesses disruptive problem behaviors via parent report. The present study compares three different conceptualizations of problem behaviors using traditional confirmatory factor analysis (CFA), a bifactor-CFA, and a bifactor exploratory structural equation model, whereof the latter two represent novel conceptualizations of disruptive problem behaviors. Data were derived from 353 Norwegian parents assigned to parent management training-the Oregon model (PMTO;  N  = 137) or brief parent training (BPT;  N  = 216), who rated their child's problem behavior (age 3-12 years). The factor models were estimated within the PMTO and BPT samples, and in the total sample. Results showed that the bifactor-CFA, with a general problem behavior factor and three specific factors representing oppositional defiant, conduct problem, and inattentive behavior provided the best model fit. Furthermore, factorial invariance across control/intervention groups and across time (pre/post intervention) was estimated within the PMTO and BPT samples. Results revealed properties of metric and intercept invariance across intervention/control groups and over time, within both interventions. Implications of the results are discussed.",2019,"Results revealed properties of metric and intercept invariance across intervention/control groups and over time, within both interventions.",['353 Norwegian parents assigned to'],['parent management training-the Oregon model (PMTO; N = 137) or brief parent training'],[],"[{'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0029195', 'cui_str': 'Oregon'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],,0.0327468,"Results revealed properties of metric and intercept invariance across intervention/control groups and over time, within both interventions.","[{'ForeName': 'Silje S', 'Initials': 'SS', 'LastName': 'Hukkelberg', 'Affiliation': 'University of Oslo, Oslo, Norway.'}]",Assessment,['10.1177/1073191117706022']
752,30907159,A qualitative exploration of the participants' experience of a web-based physiotherapy program for people with multiple sclerosis: Does it impact on the ability to increase and sustain engagement in physical activity?,"Background:  Web-based exercise and physical activity interventions are being developed as a potential way to help people with multiple sclerosis achieve and maintain increased physical activity levels. Seeking feedback from people who have used such interventions will help guide the development process. Methods:  In-depth interviews were used to explore the experiences of participants who used a web-based physiotherapy intervention as part of a feasibility randomized controlled trial. Interviews were audio-recorded, transcribed verbatim and analyzed using thematic analysis. Results:  Eleven people (age 28-68) were interviewed. Most perceived that their physical activity had increased, primarily due to completing twice-weekly web-based physiotherapy sessions. Three key themes were identified. 'It's all in one place' encompasses the value of having a convenient and portable program. 'Keeping an eye' captures people's thoughts regarding the supervision offered by the physiotherapist, through the website, and 'Hopes and expectations' reflects the importance of having opportunity to discuss what may be gained from using such a program. Conclusions:  This intervention offered a convenient, flexible and portable physiotherapy program which most people perceived helped them achieve and sustain increased levels of physical activity. Talking with people about expectations is important, particularly if a person's condition is deteriorating.IMPLICATIONS FOR REHABILITATIONWhen discussing the potential benefits of exercise programs with people with multiple sclerosis it is important to have honest and open conversations about the expectations of what may be achieved. This is particularly important for people with progressive disease.Web-based interventions may be most valuable to people who are technology literate, seek flexibility regarding where and when to exercise, prefer to exercise independently and have the confidence and skills to self-manage. Trial registration:  ClinicalTrials.gov identifier: NCT02508961.",2020,"This intervention offered a convenient, flexible and portable physiotherapy program which most people perceived helped them achieve and sustain increased levels of physical activity.","['people with progressive disease', 'people with multiple sclerosis', 'Eleven people (age 28-68']","['web-based physiotherapy program', 'web-based physiotherapy intervention']",[],"[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],,0.0662831,"This intervention offered a convenient, flexible and portable physiotherapy program which most people perceived helped them achieve and sustain increased levels of physical activity.","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dennett', 'Affiliation': 'School of Health Professions, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Coulter', 'Affiliation': 'School of Health and Life Science, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Paul', 'Affiliation': 'School of Health and Life Science, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'School of Health Professions, University of Plymouth, Plymouth, UK.'}]",Disability and rehabilitation,['10.1080/09638288.2019.1582717']
753,31616975,Changes in elastic properties of the nasal tip using Columellar strut graft versus tongue-in-groove method over one year after rhinoplasty.,"INTRODUCTION


In this study, we decided to investigate the changes in elasticity of the nasal tip using Columellar strut graft versus toung in groove method over a year after rhinoplasty.
MATERIALS AND METHODS


In this before-after randomized clinical trial study, 44 candidates for rhinoplasty were enrolled Columellar strut graft group (n = 22) and toung in groove group (n = 22). Also 22 patients who referred to ENT clinic without any previous rhinoplasty and without any decision for it during the next year, considered as control group. One group underwent columellar strut graft and the other one underwent tongue in groove rhinoplasty and in control group participants received no intervention. Nasolabial angle and elasticity of the nasal tip were recorded and compared before the surgery, immediately after the surgery, 3 months and one year after the surgery.
RESULT


There was no significant difference between the mean elasticity of the nose and the nasolabial angle before the surgery, immediately after the surgery and 3 months after the surgery between the groups. However, there was significant differences in the mean elasticity of the nose and the nasolabial angle between the groups one year after the surgery (P value < 0.05). Pearson correlation coefficient test showed a significant correlation between nasal tip elasticity 3 months and 1 year after rhinoplasty (P = 0.032, r = 0.459) and nasolabial angle 3 months and 1 year after rhinoplasty (P = 0.045, r = 0.431).
CONCLUSION


According to the results, it can be concluded that the both the Columellar strut graft and toung in groove methods improve elastic properties of the nasal tip and nasolabial angle after rhinoplasty compare to the control group.",2020,"There was no significant difference between the mean elasticity of the nose and the nasolabial angle before the surgery, immediately after the surgery and 3 months after the surgery between the groups.","['44 candidates for rhinoplasty were enrolled Columellar strut graft group (n\u2009=\u200922) and toung in groove group (n\u2009=\u200922', '22 patients who referred to ENT clinic without any previous rhinoplasty and without any decision for it during the next year, considered as control group']",['columellar strut graft and the other one underwent tongue in groove rhinoplasty and in control group participants received no intervention'],"['nasal tip elasticity', 'mean elasticity of the nose and the nasolabial angle', 'Nasolabial angle and elasticity of the nasal tip', 'elastic properties of the nasal tip and nasolabial angle']","[{'cui': 'C0035467', 'cui_str': 'Plastic operation on nose'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274038', 'cui_str': 'Ear, nose and throat surgery'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0035467', 'cui_str': 'Plastic operation on nose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0225409', 'cui_str': 'Structure of apex of nose'}, {'cui': 'C0013764'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0028429', 'cui_str': 'Nose'}, {'cui': 'C0429143', 'cui_str': 'Nasolabial angle (observable entity)'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}]",44.0,0.0343634,"There was no significant difference between the mean elasticity of the nose and the nasolabial angle before the surgery, immediately after the surgery and 3 months after the surgery between the groups.","[{'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Atighechi', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Otorhinolaryngology Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mohammadhossein', 'Initials': 'M', 'LastName': 'Dadgarnia', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Otorhinolaryngology Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Sedighe', 'Initials': 'S', 'LastName': 'Vaziribozorg', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Otorhinolaryngology Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mohammadhossein', 'Initials': 'M', 'LastName': 'Baradaranfar', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Otorhinolaryngology Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Zand', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Otorhinolaryngology Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Meybodian', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Otorhinolaryngology Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Mandegari', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Otorhinolaryngology Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Shirkhoda', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Otorhinolaryngology Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. shimashirkhoda2017@gmail.com.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-019-05662-8']
754,31858963,Tofacitinib in combination with methotrexate in patients with rheumatoid arthritis: patient-reported outcomes from the 24-month Phase 3 ORAL Scan study.,"OBJECTIVES


Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here we present data from the completed Phase 3 randomised controlled trial (RCT) ORAL Scan (NCT00847613), which evaluated the impact of tofacitinib on patient-reported outcomes (PROs) through 24 months in patients with active RA and inadequate responses to methotrexate (MTX-IR).
METHODS


Patients were randomised 4:4:1:1 to receive tofacitinib 5 or 10 mg twice daily (BID), or placebo advanced to tofacitinib 5 or 10 mg, plus background MTX. Patients receiving placebo advanced to tofacitinib at month 3 (non-responders) or month 6 (remaining patients). Mean changes from baseline in PROs, assessed at months 1-24, included Health Assessment Questionnaire-Disability Index, Patient Global Assessment of disease activity (visual analogue scale [VAS]), Patient Assessment of Arthritis Pain (VAS), health-related quality of life (Short Form-36 version 2), Functional Assessment of Chronic Illness Therapy-Fatigue and Medical Outcomes Study-Sleep.
RESULTS


Overall, 539/797 (67.6%) patients completed 24 months' treatment. At month 3, tofacitinib-treated patients reported signi cant (p<0.05) mean changes from baseline versus placebo across all PROs, and significantly more patients reported improvements ≥ minimum clinically important differences versus placebo. Improvements in PROs with tofacitinib were sustained to month 24. Following advancement to tofacitinib, placebo-treated patients generally reported changes of similar magnitude to tofacitinib-treated patients.
CONCLUSIONS


Patients with RA and MTX-IR receiving tofacitinib 5 or 10 mg BID plus MTX reported significant and clinically meaningful improvements in PROs versus placebo at month 3, which were sustained through 24 months.",2020,"At month 3, tofacitinib-treated patients reported signi cant (p<0.05) mean changes from baseline versus placebo across all PROs, and significantly more patients reported improvements ≥ minimum clinically important differences versus placebo.","['rheumatoid arthritis (RA', 'Patients', 'patients with active RA and inadequate responses to', 'patients with rheumatoid arthritis']","['Tofacitinib', 'methotrexate', 'placebo', 'MTX', 'tofacitinib 5 or 10 mg twice daily (BID), or placebo advanced to tofacitinib 5 or 10 mg, plus background MTX', 'methotrexate (MTX-IR', 'placebo advanced to tofacitinib']","['signi cant', 'Health Assessment Questionnaire-Disability Index, Patient Global Assessment of disease activity (visual analogue scale [VAS]), Patient Assessment of Arthritis Pain (VAS), health-related quality of life (Short Form-36 version 2), Functional Assessment of Chronic Illness Therapy-Fatigue and Medical Outcomes Study-Sleep']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]",,0.481424,"At month 3, tofacitinib-treated patients reported signi cant (p<0.05) mean changes from baseline versus placebo across all PROs, and significantly more patients reported improvements ≥ minimum clinically important differences versus placebo.","[{'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'First Department of Internal Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Japan.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Keystone', 'Affiliation': 'Mount Sinai Hospital, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Kremer', 'Affiliation': 'Albany Medical College, Albany, NY, USA.'}, {'ForeName': 'Cristiano A F', 'Initials': 'CAF', 'LastName': 'Zerbini', 'Affiliation': 'Centro Paulista de Investigação Clinica, São Paulo, Brazil.'}, {'ForeName': 'Mario H', 'Initials': 'MH', 'LastName': 'Cardiel', 'Affiliation': 'Centro de Investigacion Clinica de Morelia, Mexico.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Metroplex Clinical Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'University of Queensland, Australia.'}, {'ForeName': 'Yeong-Wook', 'Initials': 'YW', 'LastName': 'Song', 'Affiliation': 'Department of Internal Medicine, Medical Research Center, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Tegzová', 'Affiliation': 'Institute of Rheumatology, Prague, Czech Republic.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gruben', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Wallenstein', 'Affiliation': 'Pfizer Inc, Groton, CT, USA. genewallenstein@yahoo.com.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Connell', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'Metroplex Clinical Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical and experimental rheumatology,[]
755,31858966,Enhanced motivational interviewing for reducing weight and increasing physical activity in adults with high cardiovascular risk: the MOVE IT three-arm RCT.,"BACKGROUND


Motivational interviewing (MI) enhanced with behaviour change techniques (BCTs) and deployed by health trainers targeting multiple risk factors for cardiovascular disease (CVD) may be more effective than interventions targeting a single risk factor.
OBJECTIVES


The clinical effectiveness and cost-effectiveness of an enhanced lifestyle motivational interviewing intervention for patients at high risk of CVD in group settings versus individual settings and usual care (UC) in reducing weight and increasing physical activity (PA) were tested.
DESIGN


This was a three-arm, single-blind, parallel randomised controlled trial.
SETTING


A total of 135 general practices across all 12 South London Clinical Commissioning Groups were recruited.
PARTICIPANTS


A total of 1742 participants aged 40-74 years with a ≥ 20.0% risk of a CVD event in the following 10 years were randomised.
INTERVENTIONS


The intervention was designed to integrate MI and cognitive-behavioural therapy (CBT), delivered by trained healthy lifestyle facilitators in 10 sessions over 1 year, in group or individual format. The control group received UC.
RANDOMISATION


Simple randomisation was used with computer-generated randomisation blocks. In each block, 10 participants were randomised to the group, individual or UC arm in a 4 : 3 : 3 ratio. Researchers were blind to the allocation.
MAIN OUTCOME MEASURES


The primary outcomes are change in weight (kg) from baseline and change in PA (average number of steps per day over 1 week) from baseline at the 24-month follow-up, with an interim follow-up at 12 months. An economic evaluation estimates the relative cost-effectiveness of each intervention. Secondary outcomes include changes in low-density lipoprotein cholesterol and CVD risk score.
RESULTS


The mean age of participants was 69.75 years (standard deviation 4.11 years), 85.5% were male and 89.4% were white. At the 24-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA [mean 70.05 steps, 95% confidence interval (CI) -288 to 147.9 steps, and mean 7.24 steps, 95% CI -224.01 to 238.5 steps, respectively] or in reducing weight (mean -0.03 kg, 95% CI -0.49 to 0.44 kg, and mean -0.42 kg, 95% CI -0.93 to 0.09 kg, respectively). At the 12-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA (mean 131.1 steps, 95% CI -85.28 to 347.48 steps, and mean 210.22 steps, 95% CI -19.46 to 439.91 steps, respectively), but there were reductions in weight for the group and individual intervention arms compared with UC (mean -0.52 kg, 95% CI -0.90 to -0.13 kg, and mean -0.55 kg, 95% CI -0.95 to -0.14 kg, respectively). The group intervention arm was not more effective than the individual intervention arm in improving outcomes at either follow-up point. The group and individual interventions were not cost-effective.
CONCLUSIONS


Enhanced MI, in group or individual formats, targeted at members of the general population with high CVD risk is not effective in reducing weight or increasing PA compared with UC. Future work should focus on ensuring objective evidence of high competency in BCTs, identifying those with modifiable factors for CVD risk and improving engagement of patients and primary care.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN84864870.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 69. See the NIHR Journals Library website for further project information. This research was part-funded by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London.",2019,"At the 24-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA [mean 70.05 steps, 95% confidence interval (CI)","['adults with high cardiovascular risk', 'A total of 135 general practices across all 12 South London Clinical Commissioning Groups were recruited.\nPARTICIPANTS\n\n\nA total of 1742 participants aged 40-74 years with a ≥\u200920.0% risk of a CVD event in the following 10 years were randomised', 'patients at high risk of CVD in group settings versus', 'The mean age of participants was 69.75 years (standard deviation 4.11 years), 85.5% were male and 89.4% were white']","['Enhanced motivational interviewing', 'enhanced lifestyle motivational interviewing intervention', 'individual settings and usual care (UC', 'Motivational interviewing (MI) enhanced with behaviour change techniques (BCTs', 'integrate MI and cognitive-behavioural therapy (CBT), delivered by trained healthy lifestyle facilitators', 'UC']","['clinical effectiveness and cost-effectiveness', 'cost-effective', 'weight and increasing physical activity', 'weight and increasing physical activity (PA', 'changes in low-density lipoprotein cholesterol and CVD risk score', 'reductions in weight', 'change in weight (kg) from baseline and change in PA', 'reducing weight', 'PA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}]","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",1742.0,0.123281,"At the 24-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA [mean 70.05 steps, 95% confidence interval (CI)","[{'ForeName': 'Khalida', 'Initials': 'K', 'LastName': 'Ismail', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stahl', 'Affiliation': ""Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bayley', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Twist', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Kurtis', 'Initials': 'K', 'LastName': 'Stewart', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Ridge', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Britneff', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""Department of Primary Care and Public Health Sciences, King's College London, London, UK.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'de Zoysa', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rundle', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Cook', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Whincup', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, UK.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""Department of Health Services and Population Research, Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Section of Eating Disorders, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Greenough', 'Affiliation': ""Division of Asthma, Allergy and Lung Biology, King's College London, Guy's Hospital, London, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Winkley', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]","Health technology assessment (Winchester, England)",['10.3310/hta23690']
756,31483377,Impact of early antiretroviral treatment on sexual behaviour in the INSIGHT Strategic Timing of Anti-Retroviral Treatment (START) Trial.,"BACKGROUND


Antiretroviral treatment (ART) reduces HIV infectiousness, but the effect of early ART on sexual behaviour is unclear.
METHODS


We assessed, within the START randomised trial that enrolled HIV-positive adults with CD4>500/mm, the effect of early (immediate) versus deferred ART on: (i) condomless sex with HIV-serodifferent partners (CLS-D); (ii) all condomless sex (CLS); (iii) HIV transmission-risk-sex (CLS-D-HIV-risk, defined as CLS-D and: not on ART or started ART < 6 months ago or viral load(VL)>200c/mL or no VL in past 6 months), during two year follow-up. Month-12 CLS-D (2010-2014) was the primary outcome.
RESULTS


Among 2562 MSM, there was no difference between immediate and deferred arms in CLS-D at month 12 [12.6% versus 13.1%; difference (95% CI): -0.4% (-3.1%, 2.2%), p = 0.75] or month 24, or in CLS. Among 2010 heterosexual men and women, CLS-D at month 12 tended to be higher in the immediate versus deferred arm [10.8% versus 8.3%; difference:2.5% (-0.1%, 5.2%), p = 0.062]; the difference was greater at month 24 [9.3% versus 5.6%; difference:3.7%(1.0%, 6.4%), p = 0.007], at which time CLS was higher in the immediate arm [20.7% versus 15.7%, p = 0.013]. CLS-D-HIV-risk at month 12 was substantially lower in the immediate versus deferred arm for MSM [0.2% versus 11.0%; difference: -10.7% (-12.5%, -8.9%), p < 0.001] and heterosexuals [0.6% versus 7.7%; difference: -7.0% (-8.8%, -5.3%), p < 0.001], due to viral suppression on ART.
CONCLUSIONS


A strategy of early ART had no effect on condomless sex with HIV-serodifferent partners among MSM, but resulted in modestly higher prevalence among heterosexuals. However, among MSM and heterosexuals, early ART resulted in a substantial reduction in HIV-transmission-risk-sex, to a very low absolute level.",2019,"CLS-D-HIV-risk at month 12 was substantially lower in the immediate versus deferred arm for MSM [0.2% versus 11.0%; difference: -10.7% (-12.5%, -8.9%), p < 0.001] and heterosexuals [0.6% versus 7.7%; difference: -7.0% (-8.8%, -5.3%), p < 0.001], due to viral suppression on ART.
","['2010 heterosexual men', 'enrolled HIV-positive adults with CD4>500/mm, the effect of early (immediate) versus']","['deferred ART on: (i) condomless sex with HIV-serodifferent partners (CLS-D); (ii) all condomless sex (CLS); (iii) HIV transmission-risk-sex (CLS-D-HIV-risk, defined as CLS-D and: not on ART or started ART\u200a<\u200a6 months ago or viral load(VL)>200c/mL or no VL']","['CLS-D-HIV-risk', 'sexual behaviour', 'time CLS']","[{'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",2562.0,0.322822,"CLS-D-HIV-risk at month 12 was substantially lower in the immediate versus deferred arm for MSM [0.2% versus 11.0%; difference: -10.7% (-12.5%, -8.9%), p < 0.001] and heterosexuals [0.6% versus 7.7%; difference: -7.0% (-8.8%, -5.3%), p < 0.001], due to viral suppression on ART.
","[{'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Lampe', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Rodger', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Burman', 'Affiliation': 'Denver Public Health, University of Colorado Health Sciences Center, Denver CO, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Grulich', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Friedland', 'Affiliation': 'Departments of Medicine and Epidemiology, Yale School of Medicine, New Haven CT United States.'}, {'ForeName': 'Wafaa El', 'Initials': 'WE', 'LastName': 'Sadr', 'Affiliation': 'Columbia University, New York, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Neaton', 'Affiliation': 'University of Minnesota, Minnesota, United States.'}, {'ForeName': 'Giulio M', 'Initials': 'GM', 'LastName': 'Corbelli', 'Affiliation': 'European AIDS Treatment Group, Bruxelles, Belgium.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Emery', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jean Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Université de Paris Diderot, Paris, France.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Gatell', 'Affiliation': 'University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gerstoft', 'Affiliation': 'Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kiat', 'Initials': 'K', 'LastName': 'Ruxrungtham', 'Affiliation': 'Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Monica Barbosa de', 'Initials': 'MB', 'LastName': 'Souza', 'Affiliation': 'Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Phillips', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002359']
757,31483689,Effectiveness of Somatic Yoga and Meditation: A Pilot Study in a Multicultural Cancer Survivor Population with Chemotherapy-Induced Peripheral Neuropathy.,"Chemotherapy-induced peripheral neuropathy (CIPN) causes significant pain and is an adverse effect of treatment with chemotherapeutic agents. We explored a somatic yoga and meditation intervention in a predominantly minority population. Goals included describing strategies for minority inclusion and testing feasibility and effectiveness. Eight individuals with CIPN enrolled in a single-arm feasibility trial. Somatic yoga and meditation were provided weekly for 8 weeks, with an additional home program component. The primary outcomes were Sit and Reach, Functional Reach, and Timed Up and Go. Secondary outcomes were Patient Neurotoxicity Questionnaire, FACT-GOG-Ntx (for addressing patient concerns associated with neurological symptoms), Brief Pain Inventory, Perceived Stress Scale, Pittsburgh Sleep Quality Index, and Falls Efficacy Scale. Sensitivity to vibration was measured via biothesiometer. Participants with a mean age of 65 (49-73) years self-reported as 63% African-American and 37% Caucasian. They attended 81% of the sessions, and no adverse events we re re p o rted. CIPN symptoms (FAC T- G O G - N t x ) improved significantly (from 88.88 to 106.88, standard deviation = 20.03; p = 0.039). Fear of falling improved, approaching significance (from 39.26 to 34.38, standard deviation = 6.081; p = 0.058). Other measures showed improvement trends, with a slight increase in Brief Pain Inventory pain severity (from 3.50 to 3.75, p = 0.041) possibly reflecting comorbidities. Four qualitative themes emerged: (1) CIPN symptom variability, with musculoskeletal comorbidities; (2) utility of learned skills; (3) improvement in self-confidence, balance, and stability; and (4) social support, with CIPN experience validation and increasing health literacy. Challenges of recruitment and retention require specific outreach, community trust, and health literacy. Preliminary data suggest that somatic yoga and meditation may affect fear of falling and quality of life in cancer survivors with CIPN. A randomized controlled trial using inclusive recruitment and retention methods is indicated to establish the intervention's efficacy.",2020,"Fear of falling improved, approaching significance (from 39.26 to 34.38, standard deviation = 6.081;  p  = 0.058).","['Participants with a mean age of 65 (49-73) years self-reported as 63% African-American and 37% Caucasian', 'predominantly minority population', 'Multicultural Cancer Survivor Population with Chemotherapy-Induced Peripheral Neuropathy', 'cancer survivors with CIPN', 'Eight individuals with CIPN enrolled in a single-arm feasibility trial']","['somatic yoga and meditation', 'somatic yoga and meditation intervention', 'Somatic yoga and meditation', 'Somatic Yoga and Meditation']","['CIPN symptom variability, with musculoskeletal comorbidities; (2) utility of learned skills; (3) improvement in self-confidence, balance, and stability; and (4) social support, with CIPN experience validation and increasing health literacy', 'adverse events', 'Sit and Reach, Functional Reach, and Timed Up and Go', 'fear of falling and quality of life', 'Patient Neurotoxicity Questionnaire, FACT-GOG-Ntx (for addressing patient concerns associated with neurological symptoms), Brief Pain Inventory, Perceived Stress Scale, Pittsburgh Sleep Quality Index, and Falls Efficacy Scale', 'Brief Pain Inventory pain severity', 'CIPN symptoms (FACT-GOG-Ntx', 'Fear of falling', 'Sensitivity to vibration']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0150277'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0037438'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C1321055', 'cui_str': 'Functional reach'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034380'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0522474', 'cui_str': 'Patient concerned (contextual qualifier) (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0235031', 'cui_str': 'Neurologic Symptoms'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0222045'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}]",8.0,0.042035,"Fear of falling improved, approaching significance (from 39.26 to 34.38, standard deviation = 6.081;  p  = 0.058).","[{'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Galantino', 'Affiliation': 'Professor of Physical Therapy, Stockton University, Galloway, N.J.; University of Pennsylvania, Perelman School of Medicine, Philadelphia; and University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Brooks', 'Affiliation': 'Oncology Rehabilitation and Lymphedema Management, Bacharach Institute for Rehabilitation, Pomona, N.J.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Tiger', 'Affiliation': 'Yoga Heals 4 Life, Pomona, N.J.'}, {'ForeName': 'Shera', 'Initials': 'S', 'LastName': 'Jang', 'Affiliation': 'Stockton University, Galloway, N.J.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'Stockton University, Galloway, N.J.'}]",International journal of yoga therapy,['10.17761/2020-D-18-00030']
758,31415063,Effect of Home-Based Exercise and Weight Loss Programs on Breast Cancer-Related Lymphedema Outcomes Among Overweight Breast Cancer Survivors: The WISER Survivor Randomized Clinical Trial.,"Importance


To our knowledge, no randomized clinical trials have assessed the effects of the combination of weight loss and home-based exercise programs on lymphedema outcomes.
Objective


To assess weight loss, home-based exercise, and the combination of weight loss and home-based exercise with clinical lymphedema outcomes among overweight breast cancer survivors.
Design, Setting, and Participants


This randomized clinical trial (Women in Steady Exercise Research [WISER] Survivor clinical trial ) of 351 overweight breast cancer survivors with breast cancer-related lymphedema (BCRL) was conducted in conference rooms at academic and community hospitals and in the homes of participants from March 12, 2012, to May 28, 2016; follow-up was conducted for 1 year from the start of the intervention. Statistical analysis by intention to treat was performed from September 26, 2018, to October 28, 2018.
Interventions


A 52-week, home-based exercise program of strength/resistance training twice per week and 180 minutes of walking per week, a weight loss program of 20 weeks of meal replacements and 52 weeks of lifestyle modification counseling, and a combination of the home-based exercise and weight loss programs.
Main Outcomes and Measures


The 12-month change in the percentage of interlimb volume difference.
Results


Of 351 participants, 90 were randomized to the control group (facility-based lymphedema care with no home-based exercise or weight loss intervention), 87 to the exercise intervention group, 87 to the weight loss intervention group, and 87 to the combined exercise and weight loss intervention group; 218 (62.1%) were white, 122 (34.8%) were black, and 11 (3.1%) were of other races or ethnicities. Median time since breast cancer diagnosis was 6 years (range, 1-29 years). Mean (SD) total upper extremity score changes from the objective clinical evaluation were -1.40 (11.10) in the control group, -2.54 (13.20) in the exercise group, -3.54 (12.88) in the weight loss group, and -3.84 (10.09) in the combined group. Mean (SD) overall upper extremity score changes from the self-report survey were -0.39 (2.33) in the control group, -0.12 (2.14) in the exercise group, -0.57 (2.47) in the weight loss group, and -0.62 (2.38) in the combined group. Weight loss from baseline was -0.55% (95% CI, -2.22% to 1.11%) in the control group, -8.06% (95% CI, -9.82% to 6.29%) in the combined group, -7.37% (95% CI, -8.90% to -5.84%) in the weight loss group, and -0.44% (95% CI, -1.81% to 0.93%) in the exercise group.
Conclusions and Relevance


Study results indicate that weight loss, home-based exercise, and combined interventions did not improve BCRL outcomes; a supervised facility-based program of exercise may be more beneficial than a home-based program for improving lymphedema outcomes.
Trial Registration


ClinicalTrials.gov identifier: NCT01515124.",2019,"Weight loss from baseline was -0.55% (95% CI, -2.22% to 1.11%) in the control group, -8.06% (95% CI, -9.82% to 6.29%) in the combined group, -7.37% (95% CI,","['351 participants', 'Breast Cancer-Related Lymphedema Outcomes', 'Overweight Breast Cancer Survivors', '351 overweight breast cancer survivors with breast cancer-related lymphedema (BCRL) was conducted in conference rooms at academic and community hospitals and in the homes of participants from March 12, 2012, to May 28, 2016; follow-up was conducted for 1 year from the start of the intervention', 'group; 218 (62.1%) were white, 122 (34.8%) were black, and 11 (3.1%) were of other races or ethnicities', 'overweight breast cancer survivors']","['home-based exercise program of strength/resistance training twice per week and 180 minutes of walking per week, a weight loss program of 20 weeks of meal replacements and 52 weeks of lifestyle modification counseling, and a combination of the home-based exercise and weight loss programs', 'Home-Based Exercise and Weight Loss Programs', 'WISER', 'control group (facility-based lymphedema care with no home-based exercise or weight loss intervention), 87 to the exercise intervention group, 87 to the weight loss intervention group, and 87 to the combined exercise and weight loss intervention']","['Mean (SD) overall upper extremity score changes', 'Weight loss', 'Median time since breast cancer diagnosis', 'Mean (SD) total upper extremity score changes']","[{'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C4517683', 'cui_str': '3.1 (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2960599', 'cui_str': 'Lymphedema care'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",351.0,0.0590946,"Weight loss from baseline was -0.55% (95% CI, -2.22% to 1.11%) in the control group, -8.06% (95% CI, -9.82% to 6.29%) in the combined group, -7.37% (95% CI,","[{'ForeName': 'Kathryn H', 'Initials': 'KH', 'LastName': 'Schmitz', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State College of Medicine, Hershey.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Department of Biostatistics, New York University School of Medicine, New York.'}, {'ForeName': 'Lorraine T', 'Initials': 'LT', 'LastName': 'Dean', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'DeMichele', 'Affiliation': 'Department of Hematology/Oncology, Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Brown', 'Affiliation': 'Department of Population and Public Health Sciences, Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Sturgeon', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State College of Medicine, Hershey.'}, {'ForeName': 'Zi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Harlem Hospital Center, New York, New York.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Evangelisti', 'Affiliation': 'Department of Hematology/Oncology, Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Spinelli', 'Affiliation': 'Department of Physical Therapy, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Kallan', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Denlinger', 'Affiliation': 'Division of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cheville', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Renate M', 'Initials': 'RM', 'LastName': 'Winkels', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State College of Medicine, Hershey.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Chodosh', 'Affiliation': 'Department of Hematology/Oncology, Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Sarwer', 'Affiliation': 'Department of Social and Behavioral Sciences, Temple University, Philadelphia, Pennsylvania.'}]",JAMA oncology,['10.1001/jamaoncol.2019.2109']
759,31462735,MRD response in relapsed/refractory FL after obinutuzumab plus bendamustine or bendamustine alone in the GADOLIN trial.,"We report assessment of minimal residual disease (MRD) status and its association with outcome in rituximab-refractory follicular lymphoma (FL) in the randomized GADOLIN trial (NCT01059630). Patients received obinutuzumab (G) plus bendamustine (Benda) induction followed by G maintenance, or Benda induction alone. Patients with a clonal marker (t[14;18] translocation and/or immunoglobulin heavy or light chain rearrangement) detected at study screening were assessed for MRD at mid-induction (MI), end of induction (EOI), and every 6-24 months post-EOI/discontinuation by real-time quantitative PCR. At MI, 41/52 (79%) patients receiving G-Benda were MRD-negative vs. 17/36 (47%) patients receiving Benda alone (p = 0.0029). At EOI, 54/63 (86%) patients receiving G-Benda were MRD-negative vs. 30/55 (55%) receiving Benda alone (p = 0.0002). MRD-negative patients at EOI had improved progression-free survival (HR, 0.33, 95% CI, 0.19-0.56, p < 0.0001) and overall survival (HR, 0.39, 95% CI, 0.19-0.78, p = 0.008) vs. MRD-positive patients, and maintained their MRD-negative status for longer if they received G maintenance than if they did not. These results suggest that the addition of G to Benda-based treatment during induction can significantly contribute to the speed and depth of response, and G maintenance in MRD-negative patients potentially delays lymphoma regrowth.",2020,patients receiving Benda alone (p = 0.0029).,"['rituximab-refractory follicular lymphoma (FL', 'Patients with a clonal marker (t[14;18] translocation and/or immunoglobulin heavy or light chain rearrangement']","['obinutuzumab (G) plus bendamustine (Benda) induction followed by G maintenance, or Benda induction alone', 'bendamustine']","['MRD response', 'progression-free survival', 'overall survival']","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}]","[{'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0473059,patients receiving Benda alone (p = 0.0029).,"[{'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Pott', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany. c.pott@med2.uni-kiel.de.'}, {'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Sehn', 'Affiliation': 'British Columbia Cancer Agency and the University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Belada', 'Affiliation': 'Department of Internal Medicine-Haematology, Charles University, Hospital and Faculty of Medicine, Hradec Králové, Czech Republic.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gribben', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hoster', 'Affiliation': 'Hospital of the Ludwig-Maximilians University, Munich, Germany.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Kahl', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Kehden', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Nicolas-Virelizier', 'Affiliation': 'University of Lyon, Lyon, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Spielewoy', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Guenter', 'Initials': 'G', 'LastName': 'Fingerle-Rowson', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Harbron', 'Affiliation': 'Roche, Welwyn Garden City, UK.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Mundt', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Wassner-Fritsch', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Georgetown University Hospital, Washington, DC, USA.'}]",Leukemia,['10.1038/s41375-019-0559-9']
760,31949295,Changes in weight control behaviors and hedonic hunger in a commercial weight management program adapted for individuals with type 2 diabetes.,"BACKGROUND


A WW (formerly Weight Watchers) program adapted for persons with type 2 diabetes mellitus (T2DM) previously was found to be more effective than standard care (SC) intervention for weight loss, improved glycemic control, and weight- and diabetes-related quality of life measures. With data from the same national trial, this study examined whether WW adapted for persons with T2DM also increased engagement in weight control behaviors and decreased hedonic hunger, each of which could contribute to improved diabetes management.
INTERVENTION AND METHODS


Individuals with T2DM (n = 563) and overweight or obesity participated in a 12-month, 16-site, randomized trial of WW with diabetes counseling or SC. Hierarchical linear modeling (HLM) evaluated whether 12-month changes in weight control behaviors (Eating Behavior Inventory; EBI) and hedonic hunger (Power of Food Scale; PFS) differed by treatment condition. If a significant treatment effect was found, 12-month changes in EBI/PFS were regressed on 12-month changes in HbA 1c  and percent weight loss to explore potential treatment differences in these associations.
RESULTS


EBI scores increased significantly over the 12-months (p < 0.001), with greater improvements in WW than SC (p < 0.001). PFS decreased significantly in the 12-months (p < 0.001), with no differences between treatment groups (p = 0.15). HLM analyses that followed up on the significant treatment effect for 12-month change in EBI revealed no significant differences by treatment condition for the relationship between change in EBI scores and change in HbA 1c  (p = 0.14) or percent weight loss (p = 0.32). Across all participants, 12-month improvements in EBI and PFS were related to improved HbA 1c  (r = 0.22; -0.13, respectively) and greater percent weight loss (r = 0.41; -0.18, respectively) (ps < 0.01).
CONCLUSIONS


WW with diabetes counseling produced greater engagement in weight control behaviors in those with T2DM than did SC. Across both groups, improved weight control behaviors and hedonic hunger were related to improved glycemic control and weight loss.",2020,"PFS decreased significantly in the 12-months (p < 0.001), with no differences between treatment groups (p = 0.15).","['Individuals with T2DM (n\u2009=\u2009563) and overweight or obesity participated', 'individuals with type 2 diabetes', 'persons with type 2 diabetes mellitus (T2DM']","['diabetes counseling or SC', 'standard care (SC) intervention']","['weight control behaviors and hedonic hunger', 'EBI scores', 'glycemic control and weight loss', 'weight control behaviors (Eating Behavior Inventory; EBI) and hedonic hunger (Power of Food Scale; PFS', 'percent weight loss', 'EBI and PFS', 'weight control behaviors', 'EBI/PFS', 'EBI scores and change in HbA 1c', 'PFS']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1321111', 'cui_str': 'Weight control behavior'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0059818', 'cui_str': 'isothiocyanic acid ethylene ester'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0222045'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]",563.0,0.0155602,"PFS decreased significantly in the 12-months (p < 0.001), with no differences between treatment groups (p = 0.15).","[{'ForeName': 'Erica M', 'Initials': 'EM', 'LastName': 'Schulte', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Weight Management Center, Medical University of South Carolina, 67 President Street, Suite 410 South, Charleston, SC, 29425, USA. erica.schulte@pennmedicine.upenn.edu.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Tuerk', 'Affiliation': 'Department of Human Services, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'W Timothy', 'Initials': 'WT', 'LastName': 'Garvey', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weiss', 'Affiliation': 'Your Diabetes Endocrine Nutrition Group, Mentor, OH, USA.'}, {'ForeName': 'Kathie L', 'Initials': 'KL', 'LastName': 'Hermayer', 'Affiliation': 'Division of Endocrinology, Diabetes, & Medical Genetics, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Aronne', 'Affiliation': 'Division of Endocrinology, Diabetes, & Metabolism, Comprehensive Weight Center, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Lynne E', 'Initials': 'LE', 'LastName': 'Becker', 'Affiliation': 'TAIG, Inc, Reston, VA, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Fujioka', 'Affiliation': 'Scripps Clinical Research, San Diego, CA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Miller-Kovach', 'Affiliation': 'WW, New York, NY, USA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Kushner', 'Affiliation': 'Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Malcolm', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Weight Management Center, Medical University of South Carolina, 67 President Street, Suite 410 South, Charleston, SC, 29425, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Raum', 'Affiliation': 'Oregon Weight Loss Surgery, Portland, OR, USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Rost', 'Affiliation': 'WW, New York, NY, USA.'}, {'ForeName': 'Domenica M', 'Initials': 'DM', 'LastName': 'Rubino', 'Affiliation': 'Washington Center for Weight Management & Research, Arlington, VA, USA.'}, {'ForeName': 'Nicoleta D', 'Initials': 'ND', 'LastName': 'Sora', 'Affiliation': 'Division of Endocrinology, Diabetes, & Medical Genetics, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jan L', 'Initials': 'JL', 'LastName': 'Veliko', 'Affiliation': 'WW, New York, NY, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': ""O'Neil"", 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Weight Management Center, Medical University of South Carolina, 67 President Street, Suite 410 South, Charleston, SC, 29425, USA. oneilp@musc.edu.'}]",International journal of obesity (2005),['10.1038/s41366-020-0530-x']
761,31732174,The effects of intensive dietary weight loss and exercise on gait in overweight and obese adults with knee osteoarthritis. The Intensive Diet and Exercise for Arthritis (IDEA) trial.,"The Intensive Diet and Exercise for Arthritis (IDEA) trial was an 18-month randomized controlled trial that enrolled 454 overweight and obese older adults with symptomatic and radiographic knee osteoarthritis (OA). Participants were randomized to either exercise (E), intensive diet-induced weight loss (D), or intensive diet-induced weight loss plus exercise (D + E) interventions. We previously reported that the clinical benefits of D + E were significantly greater than with either intervention alone (e.g., greater pain reduction, and better function, mobility, and health-related quality of life). We now test the hypothesis that D + E has greater overall benefit on gait mechanics compared to either intervention alone. Knee joint loading was analyzed using inverse dynamics and musculoskeletal modeling. Analysis of covariance determined the interventions' effects on gait. The D + E group walked significantly faster at 18-month follow-up (1.35 m s -1 ) than E (1.29 m s -1 , p = 0.0004) and D (1.31 m s -1 , p = 0.0007). Tibiofemoral compressive impulse was significantly lower (p = 0.0007) in D (1069 N s) and D + E (1054 N s) compared to E (1130 N s). D had significantly lower peak hip external rotation moment (p = 0.01), hip abduction moment (p = 0.0003), and peak hip power production (p = 0.016) compared with E. Peak ankle plantar flexion moment was significantly less (p < 0.0001) in the two diet groups compared with E. There also was a significant dose-response to weight loss; participants that lost >10% of baseline body weight had significantly (p = 0.0001) lower resultant knee forces and lower muscle (quadriceps, hamstring, and gastrocnemius) forces than participants that had less weight loss. Compared to E, D produces significant load reductions at the hip, knee, and ankle; combining D with E attenuates these reductions, but most remain significantly better than with E alone.",2020,"D had significantly lower peak hip external rotation moment (p = 0.01), hip abduction moment (p = 0.0003), and peak hip power production (p = 0.016) compared with E. Peak ankle plantar flexion moment was significantly less (p < 0.0001) in the two diet groups compared with E. There also was a significant dose-response to weight loss; participants that lost >10% of baseline body weight had significantly (p = 0.0001) lower resultant knee forces and lower muscle (quadriceps, hamstring, and gastrocnemius) forces than participants that had less weight loss.","['overweight and obese adults with knee osteoarthritis', 'enrolled 454 overweight and obese older adults with symptomatic and radiographic knee osteoarthritis (OA']","['intensive dietary weight loss and exercise', 'exercise (E), intensive diet-induced weight loss (D), or intensive diet-induced weight loss plus exercise (D\u202f+\u202fE) interventions']","['Peak ankle plantar flexion moment', 'Tibiofemoral compressive impulse', 'peak hip power production', 'hip abduction moment', 'peak hip external rotation moment', 'pain reduction, and better function, mobility, and health-related quality of life', 'Knee joint loading', 'resultant knee forces and lower muscle (quadriceps, hamstring, and gastrocnemius) forces', 'weight loss']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C4517782', 'cui_str': '454 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion, function (observable entity)'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0033268'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0231462', 'cui_str': 'Lateral rotation - action (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",454.0,0.0468876,"D had significantly lower peak hip external rotation moment (p = 0.01), hip abduction moment (p = 0.0003), and peak hip power production (p = 0.016) compared with E. Peak ankle plantar flexion moment was significantly less (p < 0.0001) in the two diet groups compared with E. There also was a significant dose-response to weight loss; participants that lost >10% of baseline body weight had significantly (p = 0.0001) lower resultant knee forces and lower muscle (quadriceps, hamstring, and gastrocnemius) forces than participants that had less weight loss.","[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Messier', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA; Section on Gerontology and Geriatric Medicine, Wake Forest University School of Medicine, USA. Electronic address: messier@wfu.edu.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': 'Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC, USA. Electronic address: dbeavers@wakehealth.edu.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Mihalko', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA. Electronic address: mihalksl@wfu.edu.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Miller', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA. Electronic address: millergd@wfu.edu.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Lyles', 'Affiliation': 'Section on Gerontology and Geriatric Medicine, Wake Forest University School of Medicine, USA. Electronic address: mlyles@wakehealth.edu.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, Australia; Rheumatology Department, Royal North Shore Hospital, Australia. Electronic address: david.hunter@sydney.edu.au.'}, {'ForeName': 'J Jeffery', 'Initials': 'JJ', 'LastName': 'Carr', 'Affiliation': 'Department of Radiology, Vanderbilt School of Medicine, Nashville, TN, USA. Electronic address: j.jeffrey.carr@vanderbilt.edu.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Eckstein', 'Affiliation': 'Institute of Anatomy and Musculoskeletal Research, Paracelsus Medical University, Salzburg, Austria, & Chondrometrics GmbH, Ainring, Germany. Electronic address: felix.eckstein@pmu.ac.at.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Guermazi', 'Affiliation': 'Department of Radiology, Boston University School of Medicine, Boston, MA, USA. Electronic address: guermazi@bu.edu.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Loeser', 'Affiliation': 'Thurston Arthritis Research Center, University of North Carolina School of Medicine, Chapel Hill, NC, USA. Electronic address: richard_loeser@med.unc.edu.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'DeVita', 'Affiliation': 'Department of Kinesiology, East Carolina University, Greenville, NC, USA. Electronic address: DEVITAP@ecu.edu.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2019.109477']
762,32439503,Pressure-Support Ventilation vs T-Piece During Spontaneous Breathing Trials Before Extubation Among Patients at High Risk of Extubation Failure: A Post-Hoc Analysis of a Clinical Trial.,"BACKGROUND


Spontaneous breathing trial (SBT) using a T-piece remains the most frequently performed trial before extubation in ICUs.
RESEARCH QUESTION


We aimed at determining whether initial SBT using pressure-support ventilation (PSV) could increase successful extubation rates among patients at high risk of extubation failure.
STUDY DESIGN AND METHODS


Post hoc analysis of a multicenter trial focusing on reintubation in patients at high-risk of extubation failure. The initial SBT was performed using PSV or T-piece according to the physician/center decision. The primary outcome was the proportion of patients successfully extubated 72 hours after initial SBT, that is, extubated after initial SBT and not reintubated within the following 72 hours.
RESULTS


Among the 641 patients included in the original study, initial SBT was performed using PSV (7.0 cm H 2 O in median without positive end-expiratory pressure) in 243 patients (38%) and using a T-piece in 398 patients (62%). The proportion of patients successfully extubated 72 hours after initial SBT was 67% (162/243) using PSV and 56% (223/398) using T-piece (absolute difference 10.6%; 95% CI, 2.8 to 28.1; P = .0076). The proportion of patients extubated after initial SBT was 77% (186/283) using PSV and 63% (249/398) using T-piece (P = .0002), whereas reintubation rates within the following 72 hours did not significantly differ (13% vs 10%, respectively; P = .4259). Performing an initial SBT using PSV was independently associated with successful extubation (adjusted OR, 1.60; 95% CI, 1.30 to 2.18; P = .0061).
INTERPRETATION


In patients at high risk of extubation failure in the ICU, performing an initial SBT using PSV may hasten extubation without an increased risk of reintubation.",2020,"Performing an initial SBT using PSV was independently associated with successful extubation (adjusted odds ratio 1.60, 95% CI 1.30 to 2.18; p=0.0061).
","['641 patients included in the original study, initial SBT', 'patients at high-risk of extubation failure']","['Pressure-support ventilation versus T-piece', 'SBT using pressure-support ventilation (PSV']","['successful extubation', 'successful extubation rates', 'proportion of patients extubated after initial SBT', 'proportion of patients successfully extubated 72h after initial SBT', 'proportion of patients successfully extubated 72h after initial SBT, i.e. extubated after initial SBT', 'reintubation rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}]",641.0,0.20449,"Performing an initial SBT using PSV was independently associated with successful extubation (adjusted odds ratio 1.60, 95% CI 1.30 to 2.18; p=0.0061).
","[{'ForeName': 'Arnaud W', 'Initials': 'AW', 'LastName': 'Thille', 'Affiliation': ""Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France; INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France. Electronic address: aw.thille@gmail.com.""}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Coudroy', 'Affiliation': ""Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France; INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.""}, {'ForeName': 'Mai-Anh', 'Initials': 'MA', 'LastName': 'Nay', 'Affiliation': ""Centre Hospitalier Régional d'Orléans, Médecine Intensive Réanimation, Orléans, France.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Gacouin', 'Affiliation': 'Centre Hospitalier Universitaire de Rennes, Hôpital Ponchaillou, Service des Maladies Infectieuses et Réanimation Médicale, Rennes, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Demoule', 'Affiliation': 'Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine Intensive et Réanimation (Département R3S), UMRS1158 neurophysiologie respiratoire expérimentale et clinique, Sorbonne Université, Paris, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Sonneville', 'Affiliation': 'Hôpital Bichat-Claude Bernard, Médecine Intensive Réanimation, Université Paris Diderot, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Beloncle', 'Affiliation': ""Centre Hospitalier Universitaire d'Angers, Département de Médecine Intensive Réanimation, Université d'Angers, Angers, France.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Girault', 'Affiliation': 'Centre Hospitalier Universitaire de Rouen, Hôpital Charles Nicolle, Département de Réanimation Médicale, Normandie Université, Institute for Research and Innovation in Biomedicine (IRIB), Rouen, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Dangers', 'Affiliation': 'Centre Hospitalier Universitaire Félix Guyon, Service de Réanimation Polyvalente, Saint Denis de la Réunion, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lautrette', 'Affiliation': 'Centre Hospitalier Universitaire de Clermont-Ferrand, Hôpital Gabriel Montpied, Service de Réanimation Médicale, Clermont-Ferrand, France.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Levrat', 'Affiliation': 'Centre Hospitalier de La Rochelle, Service de Réanimation, La Rochelle, France.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Rouzé', 'Affiliation': 'Centre Hospitalier Universitaire de Lille, Centre de Réanimation, Université de Lille, Lille, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Vivier', 'Affiliation': 'Hôpital Saint-Joseph Saint-Luc, Réanimation Polyvalente, Lyon, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Lascarrou', 'Affiliation': 'Centre Hospitalier Universitaire de Nantes, Médecine Intensive Réanimation, Nantes, France.'}, {'ForeName': 'Jean-Damien', 'Initials': 'JD', 'LastName': 'Ricard', 'Affiliation': 'Hôpital Louis Mourier, Réanimation Médico-Chirurgicale, Université Paris Diderot, Sorbonne Paris Cité, Colombes, France.'}, {'ForeName': 'Keyvan', 'Initials': 'K', 'LastName': 'Razazi', 'Affiliation': 'Hôpitaux universitaires Henri Mondor, Service de Réanimation Médicale DHU A-TVB, Créteil, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Barberet', 'Affiliation': 'Groupe Hospitalier Régional Mulhouse Sud Alsace, site Emile Muller, Service de Réanimation Médicale, Mulhouse, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lebert', 'Affiliation': 'Centre Hospitalier Départemental de Vendée, Service de Médecine Intensive Réanimation, La Roche Sur Yon, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrmann', 'Affiliation': ""Centre Hospitalier Régional Universitaire de Tours, Médecine Intensive Réanimation, Réseau CRICS-Trigger SEP, Centre d'étude des pathologies respiratoires, Université de Tours, Tours, France.""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Massri', 'Affiliation': 'Centre Hospitalier de Pau, Service de Réanimation, Pau, France.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Bourenne', 'Affiliation': 'Centre Hospitalier Universitaire La Timone 2, Médecine Intensive Réanimation, Réanimation des Urgences, Aix-Marseille Université, Marseille, France.'}, {'ForeName': 'Gael', 'Initials': 'G', 'LastName': 'Pradel', 'Affiliation': ""Centre Hospitalier Henri Mondor d'Aurillac, Service de Réanimation, Aurillac, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bailly', 'Affiliation': 'Centre Hospitalier Universitaire de Brest, Médecine Intensive Réanimation, Brest, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Terzi', 'Affiliation': 'Centre Hospitalier Universitaire Grenoble Alpes, Médecine Intensive Réanimation, INSERM, Université Grenoble-Alpes, Grenoble, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Dellamonica', 'Affiliation': ""Centre Hospitalier Universitaire de Nice, Médecine Intensive Réanimation, Archet 1, Université Cote d'Azur, Nice, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lacave', 'Affiliation': 'Centre Hospitalier de Versailles, Service de Réanimation Médico-Chirurgicale, Le Chesnay, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Robert', 'Affiliation': ""Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France; INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.""}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Ragot', 'Affiliation': ""INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Frat', 'Affiliation': ""Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France; INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chest,['10.1016/j.chest.2020.04.053']
763,31422713,"Effects of vortioxetine on functional capacity across different levels of functional impairment in patients with major depressive disorder: a University of California, San Diego Performance-based Skills Assessment (UPSA) analysis.","Objective:  To evaluate the consistency of vortioxetine's effects on functional capacity in adults with major depressive disorder (MDD) and self-reported cognitive symptoms at different levels of functional impairment. Methods:  An exploratory analysis of data from a randomized, placebo-controlled, duloxetine-referenced study (NCT01564862) involving 529 patients with moderate to severe MDD treated once-daily with vortioxetine 10/20 mg, duloxetine 60 mg, or placebo for 8 weeks. Analysis of the University of California, San Diego Performance-based Skills Assessment (UPSA) composite scores stratified patients into subgroups by baseline functional impairment and assessed clinically important differences using several cutoffs for change from baseline (CFB) (least-square means) in UPSA composite score. A path analysis was also conducted to determine the proportion of direct versus indirect effects of vortioxetine on functional capacity. Results:  Vortioxetine significantly separated from placebo across different baseline levels of functional impairment, particularly at the ≤70 cutoff (mean difference = 5.9, 95% confidence interval, 1.5-10.4). A greater proportion of patients treated with vortioxetine than placebo exhibited UPSA composite score response at each threshold analyzed and were classified as responders based on UPSA CFB of ≥7 ( p  = 0.006) or ≥9 ( p  = 0.016). No significant effects were observed for duloxetine versus placebo for any baseline levels of functional impairment or response thresholds. Path analysis demonstrated that 96.9% of the effects on functional capacity can be directly attributed to the treatment effect of vortioxetine and are not mediated by improvements in depressive symptoms as measured by MADRS. Conclusion:  The effects of vortioxetine on functional capacity is robust across different level of functional impairment in patients with MDD. The effect on functional capacity was largely independent of the effect on depressive symptoms.  Trial Registration:  ClinicalTrials.gov identifier: NCT01564862: https://clinicaltrials.gov/ct2/show/NCT01564862; European Clinical Trials Database [EudraCT] Number 2011-005298-22: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-005298-22/DE.",2020,The effects of vortioxetine on functional capacity is robust across different level of functional impairment in patients with MDD.,"['patients with major depressive disorder', '529 patients with moderate to severe MDD treated once-daily with', 'patients with MDD', 'adults with major depressive disorder (MDD']","['duloxetine', 'placebo', 'vortioxetine', 'vortioxetine 10/20\u2009mg, duloxetine 60\u2009mg, or placebo', 'Vortioxetine', 'placebo-controlled, duloxetine']","['functional capacity', 'depressive symptoms', 'University of California, San Diego Performance-based Skills Assessment (UPSA) composite scores', 'UPSA composite score response', 'functional impairment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4517806', 'cui_str': '529 (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C1702579', 'cui_str': 'duloxetine 60 MG [Cymbalta]'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",529.0,0.625104,The effects of vortioxetine on functional capacity is robust across different level of functional impairment in patients with MDD.,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Jacobson', 'Affiliation': 'Clinical Science, Takeda Development Center Americas, Inc, Deerfield, IL, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': 'CNS Statistics, Takeda Development Center Americas, Inc, Deerfield, IL, USA.'}, {'ForeName': 'George G', 'Initials': 'GG', 'LastName': 'Nomikos', 'Affiliation': 'Clinical Science, Takeda Development Center Americas, Inc, Deerfield, IL, USA.'}, {'ForeName': 'Michael Cronquist', 'Initials': 'MC', 'LastName': 'Christensen', 'Affiliation': 'Trintellix® Medical Affairs, H. Lundbeck a/S, Copenhagen, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kurre Olsen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, FL, USA.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Harvey', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, FL, USA.'}]",Current medical research and opinion,['10.1080/03007995.2019.1657692']
764,30759467,Comparison between a rotatable sphincterotome and a conventional sphincterotome for selective bile duct cannulation.,"BACKGROUND


Selective biliary cannulation (SBC) is the first challenge of endoscopic retrograde cholangiopancreatography (ERCP), especially for trainees, and a rotatable sphincterotome may be useful to guide the directional axis of the scope and SBC.
METHODS


We performed a prospective randomized single-center trial, enrolling 200 patients with a native papilla who required therapeutic biliary ERCP. Patients were randomly assigned to the rotatable sphincterotome group (n = 100) or the conventional sphincterotome group (n = 100). The primary endpoint was successful SBC by the trainees within 10 minutes.
RESULTS


The early and late cannulation success rates did not differ significantly between the groups ( P  = 0.46 and  P  > 0.99, respectively). For the patients in whom trainees failed to achieve SBC, the rotatable sphincterotome was used as a rescue cannulation technique in four patients from the conventional group; in no patients in the rotatable group was the conventional sphincterotome used for SBC. Post-ERCP pancreatitis (PEP) occurred in 11 patients (5.5 %; 6 mild, 5 moderate); the incidence did not differ significantly between the two groups (rotatable group 3 %, conventional group 8 %;  P  = 0.21). The two groups were thus combined for evaluation of the factors relating to cannulation difficulty for trainees, which revealed that orientation of the papilla was a significant factor ( P  < 0.001).
CONCLUSIONS


The type of sphincterotome used did not affect the success of SBC by trainees. However, orientation of the papilla was revealed to be a significant factor relating to cannulation difficulty for trainees overall.",2019,"The early and late cannulation success rates did not differ significantly between the groups ( P  = 0.46 and  P  > 0.99, respectively).",['200 patients with a native papilla who required therapeutic biliary ERCP'],"['rotatable sphincterotome', 'rotatable sphincterotome and a conventional sphincterotome', 'Selective biliary cannulation (SBC', 'endoscopic retrograde cholangiopancreatography (ERCP', 'conventional sphincterotome']","['late cannulation success rates', 'successful SBC', 'Post-ERCP pancreatitis (PEP']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}]","[{'cui': 'C0183424', 'cui_str': 'Sphincterotome'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}]",200.0,0.040633,"The early and late cannulation success rates did not differ significantly between the groups ( P  = 0.46 and  P  > 0.99, respectively).","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kurita', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Kudo', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Innovative Clinical Research Center, Kanazawa University Hospital, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Tadamasa', 'Initials': 'T', 'LastName': 'Takemura', 'Affiliation': 'Graduate School of Applied Informatics, University of Hyogo, Kobe Chuo-ku, Hyogo, Japan.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Mori', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Shunjiro', 'Initials': 'S', 'LastName': 'Azuma', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Sono', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Yamakawa', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Koutarou', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Nishimura', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yamashita', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Akiyama', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Mayuki', 'Initials': 'M', 'LastName': 'Omatsu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Shujiro', 'Initials': 'S', 'LastName': 'Yazumi', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}]",Endoscopy,['10.1055/a-0835-5900']
765,31256116,"The Effectiveness of a Web-Based Health Education Tool, WESIHAT 2.0, among Older Adults: A Randomized Controlled Trial.","BACKGROUND


Intervention strategies, especially online based approaches, are considered to be beneficial in improving the health of the senior. The effectiveness of such approaches is yet to be determined.
OBJECTIVE


This study aims to determine the effectiveness of the web-based application, WESIHAT 2.0©, for improving cognitive function, physical fitness, biochemical indices, and psychosocial variables among older adults in Klang Valley, Malaysia. The cost analysis of WESIHAT 2.0© was also determined.
METHOD


The study utilized a two-arm randomized controlled trial with 25 subjects in each of the intervention and control groups. The participants chosen for the study included those who were 60 years and above with at least secondary education and had internet access using a computer at home. The intervention group was exposed to the website (30 minutes per day, 4 days per week) for six months, while the control group was given health education pamphlets. Activity-Based Costing method was used to determine the cost saved using WESIHAT 2.0© as compared to using the pamphlet.
RESULTS


Significant intervention effects were observed for self-perception of disability and informational support scores. WESIHAT 2.0© was able to save costs in improving the self-perception of disability score and the informational support score at MYR 6.92 and MYR 13.52, respectively, compared to the conventional method.
CONCLUSION


WESIHAT 2.0© was able to save costs in improving the self-perceived disability and informational support scores for the intervention group.",2019,WESIHAT 2.0© was able to save costs in improving the self-perceived disability and informational support scores for the intervention group.,"['25 subjects in each of the intervention and control groups', 'older adults in Klang Valley, Malaysia', 'Older Adults', 'participants chosen for the study included those who were 60 years and above with at least secondary education and had internet access using a computer at home']",['control group was given health education pamphlets'],"['self-perception of disability score and the informational support score', 'cognitive function, physical fitness, biochemical indices, and psychosocial variables', 'self-perception of disability and informational support scores', 'self-perceived disability and informational support scores']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0563004', 'cui_str': 'Valley (environment)'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4704731', 'cui_str': 'Internet Access'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0018701'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0242498', 'cui_str': 'Self-Perception'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",,0.0503029,WESIHAT 2.0© was able to save costs in improving the self-perceived disability and informational support scores for the intervention group.,"[{'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Vanoh', 'Affiliation': 'Nutrition and Dietetics Programme, School of Health Sciences, Universiti Sains Malaysia, Health Campus, Kubang Kerian, Kelantan.'}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Shahar', 'Affiliation': 'Centre for Healthy Ageing and Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Rosdinom', 'Initials': 'R', 'LastName': 'Razali', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Jalan Yaacob Latif, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Nazlena Mohamad', 'Initials': 'NM', 'LastName': 'Ali', 'Affiliation': 'Institute of Visual Informatics (IVI), Universiti Kebangsaan Malaysia, Bangi Selangor, Malaysia.'}, {'ForeName': 'Zahara Abdul', 'Initials': 'ZA', 'LastName': 'Manaf', 'Affiliation': 'Centre for Healthy Ageing and Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Shahrul Azman', 'Initials': 'SA', 'LastName': 'Mohd Noah', 'Affiliation': 'School of Information Technology, Faculty of Information Science and Technology, Universiti Kebangsaan Malaysia, Bangi Selangor, Malaysia.'}, {'ForeName': 'Amrizal Muhammad', 'Initials': 'AM', 'LastName': 'Nur', 'Affiliation': 'International Centre for Casemix and Clinical Coding, Universiti Kebangsaan Malaysia Medical Centre, Jalan Yaacob Latif, Kuala Lumpur, Malaysia.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-180464']
766,31789554,Female drinkers are more sensitive than male drinkers to alcohol-induced heart rate increase.,"The present study examined the acute effect of alcohol and its cues on autonomic and cardiovascular physiology, as indexed by changes in heart rate (HR), in a relatively large sample of healthy young adult men and women. Participants (27-31 years old, final  N  = 145) were administered an alcoholic beverage ( n  = 88; 52 women) or a placebo beverage ( n  = 57; 35 women) in a simulated bar. Target breath alcohol concentration (BrAC) was .08 g%. HR was recorded while participants were seated alone during an initial baseline assessment in a lab room; seated with others during preparation and administration of 2 beverages in a simulated bar; and seated alone in the lab room at ascending, peak, and descending BrAC. HR increased over time for participants in both beverage groups during beverage preparation. During beverage consumption, HR decreased over time in those who drank placebo whereas HR increased over time in those who drank alcohol, increasing at a faster rate in women compared to men. HR remained elevated at the ascending, peak, and descending limb assessments only in participants who drank alcohol with HR increasing over time at ascending BrAC in the women but not men. Sex differences in HR under alcohol were not explained by sex differences in body mass index, BrAC, recent alcohol use, or subjective stimulation. Our findings suggest that women may be more sensitive to alcohol-induced increases in HR, especially in environments where alcohol cues are abundant. This may have implications for cardiovascular risks associated with alcohol. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Sex differences in HR under alcohol were not explained by sex differences in body mass index, BrAC, recent alcohol use, or subjective stimulation.","['Participants (27-31 years old, final  N  = 145', 'healthy young adult men and women', 'Female drinkers']","['placebo', 'placebo beverage', 'alcoholic beverage']","['HR', 'Target breath alcohol concentration (BrAC', 'heart rate (HR']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic Beverages'}]","[{'cui': 'C0277982', 'cui_str': 'Smell of alcohol on breath (finding)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",2019.0,0.0349077,"Sex differences in HR under alcohol were not explained by sex differences in body mass index, BrAC, recent alcohol use, or subjective stimulation.","[{'ForeName': 'Roberto U', 'Initials': 'RU', 'LastName': 'Cofresí', 'Affiliation': 'Department of Psychological Sciences, The University of Missouri.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Bartholow', 'Affiliation': 'Department of Psychological Sciences, The University of Missouri.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Fromme', 'Affiliation': 'Department of Psychology, The University of Texas at Austin.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000338']
767,32437174,"A transdiagnostic minority stress intervention for gender diverse sexual minority women's depression, anxiety, and unhealthy alcohol use: A randomized controlled trial.","OBJECTIVE


To remedy the notable gap in evidence-based treatments for sexual minority women, this study tested the efficacy of a minority-stress-focused cognitive-behavioral treatment intended to improve this population's mental and behavioral health.
METHOD


The intervention, EQuIP (Empowering Queer Identities in Psychotherapy), was adapted from a transdiagnostic cognitive-behavioral treatment as also recently adapted for sexual minority men. Sexual minority women at risk of mental and behavioral health problems ( n  = 19) and expert providers with this population ( n  = 12) shaped the treatment's development, including by supporting its primary focus on universal and minority-stress-focused processes underlying this population's disproportionately poor mental and behavioral health. The resulting treatment was then delivered to young adult sexual minority women ( n  = 60;  M  age = 25.58; 41.67% racial/ethnic minority; 43.33% transgender/nonbinary) experiencing depression/anxiety and past 90-day heavy alcohol use.
RESULTS


Compared to waitlist ( n  = 30), participants randomized to immediately receive EQuIP ( n  = 30) experienced significantly reduced depression and anxiety ( d  = 0.85, 0.86, respectively); effects for alcohol use problems were smaller ( d  = 0.29) and marginally significant. In pre- to post-intervention pooled analyses, effect sizes for minority stress processes (mean  d  = .25) and universal risk factors (mean  d  = .48), through which the treatment was expected to work, were small and moderate, respectively, and in the expected direction.
CONCLUSIONS


This study provides initial support for a minority-stress-focused transdiagnostic cognitive-behavioral treatment for sexual minority women. These first results can launch exploration of other mechanisms and modalities through which to equip this population with evidence-based support. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"In pre- to post-intervention pooled analyses, effect sizes for minority stress processes (mean  d  = .25) and universal risk factors (mean  d  = .48), through which the treatment was expected to work, were small and moderate, respectively, and in the expected direction.
","['sexual minority men', ""Sexual minority women at risk of mental and behavioral health problems ( n  = 19) and expert providers with this population ( n  = 12) shaped the treatment's development, including by supporting its primary focus on universal and minority-stress-focused processes underlying this population's disproportionately poor mental and behavioral health"", ""gender diverse sexual minority women's depression, anxiety, and unhealthy alcohol use"", 'sexual minority women', 'young adult sexual minority women ( n  = 60;  M  age = 25.58; 41.67% racial/ethnic minority; 43.33% transgender/nonbinary) experiencing depression/anxiety and past 90-day heavy alcohol use']","['transdiagnostic minority stress intervention', 'EQuIP']","['universal risk factors', 'depression and anxiety']","[{'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}]","[{'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0292329,"In pre- to post-intervention pooled analyses, effect sizes for minority stress processes (mean  d  = .25) and universal risk factors (mean  d  = .48), through which the treatment was expected to work, were small and moderate, respectively, and in the expected direction.
","[{'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Pachankis', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'McConocha', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Kirsty A', 'Initials': 'KA', 'LastName': 'Clark', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Kriti', 'Initials': 'K', 'LastName': 'Behari', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Fetzner', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Cal D', 'Initials': 'CD', 'LastName': 'Brisbin', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Jillian R', 'Initials': 'JR', 'LastName': 'Scheer', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Lehavot', 'Affiliation': 'Denver-Seattle Center of Innovation for Veteran-Centered and Value-Driven Care.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000508']
768,32130593,Brief Report: Impact of a Physical Exercise Intervention on Emotion Regulation and Behavioral Functioning in Children with Autism Spectrum Disorder.,Problems with emotion regulation and behavior are often reported in children with autism spectrum disorders (ASD). This pilot study examined the effect of physical exercise on emotion regulation and behavioral functioning in children with ASD. Twenty-seven children aged 8-12 years were randomized into either an exercise intervention group (n = 15) or a control group (n = 12). The intervention group received a 12-week jogging intervention. Children's parents completed the Emotion Regulation Checklist and the Child Behavior Checklist pre- and post-intervention. The intervention group demonstrated significant improvement in emotion regulation and reduction in behavioral problems (ps < .05). Future studies should explore the mechanisms underlying the effects of physical exercise on emotion regulation and behavior in children with ASD.,2020,The intervention group demonstrated significant improvement in emotion regulation and reduction in behavioral problems (ps < .05).,"['children with ASD', 'Twenty-seven children aged 8-12\xa0years', 'children with autism spectrum disorders (ASD', 'Children with Autism Spectrum Disorder']","['exercise intervention', 'physical exercise', '12-week jogging intervention', 'Physical Exercise Intervention']","['emotion regulation and reduction in behavioral problems', 'emotion regulation and behavioral functioning', 'Emotion Regulation and Behavioral Functioning', 'Emotion Regulation Checklist and the Child Behavior Checklist pre']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0022400', 'cui_str': 'Jogging'}]","[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]",27.0,0.01996,The intervention group demonstrated significant improvement in emotion regulation and reduction in behavioral problems (ps < .05).,"[{'ForeName': 'Andy C Y', 'Initials': 'ACY', 'LastName': 'Tse', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong, Rm D4-2/F-07, Block D4, 10 Lo Ping Road, Tai Po, N.T., Hong Kong, China. andytcy@eduhk.hk.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04418-2']
769,32441875,Infant feeding beliefs and practices: Effects of maternal personal characteristics.,"PURPOSE


Information is limited about how mothers make food decisions on behalf of their children. Eating practices are established early in life and are difficult to change, so it is imperative to focus on the caregiver who influences a young child's food preferences and eating behaviors. The purpose of this secondary data analysis was to examine the relationship between maternal characteristics and infant feeding beliefs and practices in a sample of multiparous mothers with a history of a prior preterm infant birth.
DESIGN AND METHODS


Secondary analysis of a subset of data (n = 112) collected from women who participated in a randomized clinical trial (RCT) assessing the efficacy of a home-based intervention to improve maternal and child outcomes. Inclusion criteria for the RCT: women ≥18 years of age at enrollment with a prior preterm live birth >20 and <37 weeks gestation, <24 weeks gestation at enrollment, spoke/read English, and received prenatal care at a regional medical center. Criteria for the subset included: completed the Infant Feeding Questionnaire at 5 months postpartum and had reported a prenatal body mass index (BMI). Univariate correlations and multiple linear regression analyses were used to assess the associations between maternal personal characteristics and infant feeding practices.
RESULTS


Median age of the mothers was 27 years (interquartile range [IQR]: 23-32) with median education of 12 years (IQR: 12-16). More than two-thirds (68%) of the women breastfed their last baby. These women were less likely to be concerned about their infant's hunger (r = -.20; p = .035). After controlling for education, maternal BMI, breastfed last baby, self-esteem, locus of control, and depressive symptoms, decreased maternal age (β = -.35; p < .001) and higher levels of stress (β = .19; p = .042) were associated with greater concern about their infant's hunger. Maternal demographic and psychosocial variables were not found to be statistically significantly associated with either concern about infant overeating and becoming overweight or an awareness of infant's hunger and satiety cues.
PRACTICE IMPLICATIONS


Differences in maternal psychosocial variables and attitudes toward infant feeding may contribute to long term eating habits and weight outcomes in children. A better understanding of maternal variables that influence infant feeding attitudes and practices could improve the design of future intervention studies aimed at mothers at risk for having poor infant feeding practices.",2020,"Maternal demographic and psychosocial variables were not found to be statistically significantly associated with either concern about infant overeating and becoming overweight or an awareness of infant's hunger and satiety cues.
","['children', 'Median age of the mothers was 27\u2009years (interquartile range [IQR]: 23-32) with median education of 12 years (IQR: 12-16', 'Secondary analysis of a subset of data (n\u2009=\u2009112) collected from women who participated', 'multiparous mothers with a history of a prior preterm infant birth', 'women ≥18 years of age at enrollment with a prior preterm live birth >20 and <37 weeks gestation, <24 weeks gestation at enrollment, spoke/read English, and received prenatal care at a regional medical center', 'mothers at risk for having poor infant feeding practices']","['RCT', 'home-based intervention']","['education, maternal BMI, breastfed last baby, self-esteem, locus of control, and depressive symptoms', 'Maternal demographic and psychosocial variables', 'prenatal body mass index (BMI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026751', 'cui_str': 'Multiparous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C1277154', 'cui_str': 'Reads English'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0023953', 'cui_str': 'Locus of Control'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]",,0.112608,"Maternal demographic and psychosocial variables were not found to be statistically significantly associated with either concern about infant overeating and becoming overweight or an awareness of infant's hunger and satiety cues.
","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bushaw', 'Affiliation': ""Gillette Children's Specialty Healthcare, Nursing Administration, St. Paul, Minnesota.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Lutenbacher', 'Affiliation': 'Vanderbilt University, School of Nursing, Nashville, Tennessee.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Karp', 'Affiliation': 'Vanderbilt University, School of Nursing, Nashville, Tennessee.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dietrich', 'Affiliation': 'Statistics and Measurement, Vanderbilt University, School of Nursing, Nashville, Tennessee.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Graf', 'Affiliation': 'Vanderbilt University, School of Nursing, Nashville, Tennessee.'}]",Journal for specialists in pediatric nursing : JSPN,['10.1111/jspn.12294']
770,30537098,Neuroactive steroid levels and cocaine use chronicity in men and women with cocaine use disorder receiving progesterone or placebo.,"BACKGROUND AND OBJECTIVES


Neuroactive steroids (NAS) may play a role in addiction, with observed increases in response to acute stress and drug use, but decreases with chronic substance use, suggesting that NAS neuroadaptations may occur with chronic substance use. However, levels of NAS in addicted individuals have not been systematically examined. Here, we evaluated a panel of NAS in men and women with cocaine use disorder (CUD) who participated in a clinical laboratory study of progesterone.
METHODS


Forty six CUD individuals were enrolled in a randomized placebo-controlled laboratory study to evaluate progesterone effects on levels of various NAS. On day 5 of a 7-day inpatient treatment regimen of 400 mg/day progesterone (15M/8F) or placebo (14M/9F), plasma levels of NAS known to be downstream of progesterone (allopregnanolone, pregnanolone), and NAS not in the progesterone synthesis pathway (androstanediol, testosterone, dehydroepiandrosterone [DHEA] and the NAS precursor, pregnenolone) were analyzed using highly sensitive gas chromatography/mass spectrometry (GC/MS). The relationship between each of the NAS and chronicity of cocaine use was also assessed.
RESULTS


Progesterone versus placebo significantly increased the GABAergic NAS allopregnanolone and pregnanolone in both CUD men and women. Levels of pregnenolone, testosterone, its GABAergic metabolite androstanediol, and the non-GABAergic DHEA were unaffected by progesterone treatment, and testosterone and androstanediol levels were significantly higher in men than women. Importantly, lower pregnenolone and androstanediol levels were associated with greater years of cocaine use.
SCIENTIFIC SIGNIFICANCE


GABAergic NAS that are upstream from the progesterone synthesis pathway appear susceptible to chronic effects of cocaine use. (Am J Addict 2019;28:16-21).",2019,"RESULTS


Progesterone versus placebo significantly increased the GABAergic NAS allopregnanolone and pregnanolone in both CUD men and women.","['men and women with cocaine use disorder receiving', 'CUD men and women', 'men and women with cocaine use disorder (CUD) who participated in a clinical laboratory study of progesterone', 'Forty six CUD individuals']","['400\u2009mg/day progesterone (15M/8F) or placebo', 'progesterone (allopregnanolone, pregnanolone), and NAS not in the progesterone synthesis pathway (androstanediol, testosterone, dehydroepiandrosterone [DHEA] and the NAS precursor, pregnenolone', 'progesterone or placebo', 'placebo']","['levels of NAS', 'testosterone and androstanediol levels', 'GABAergic NAS allopregnanolone and pregnanolone', 'Levels of pregnenolone, testosterone, its GABAergic metabolite androstanediol, and the non-GABAergic DHEA', 'lower pregnenolone and androstanediol levels']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376202', 'cui_str': 'Allopregnanolone'}, {'cui': 'C0033008', 'cui_str': '3-Hydroxypregnan-20-one'}, {'cui': 'C0486333', 'cui_str': '3-alpha-Androstanediol'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0373704', 'cui_str': 'Pregnenolone'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0486333', 'cui_str': '3-alpha-Androstanediol'}, {'cui': 'C0376202', 'cui_str': 'Allopregnanolone'}, {'cui': 'C0033008', 'cui_str': '3-Hydroxypregnan-20-one'}, {'cui': 'C0373704', 'cui_str': 'Pregnenolone'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",,0.0781229,"RESULTS


Progesterone versus placebo significantly increased the GABAergic NAS allopregnanolone and pregnanolone in both CUD men and women.","[{'ForeName': 'Verica', 'Initials': 'V', 'LastName': 'Milivojevic', 'Affiliation': 'The Yale Stress Center, Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Covault', 'Affiliation': 'Alcohol Research Center, Department of Psychiatry, University of Connecticut School of Medicine, Farmington, Connecticut.'}, {'ForeName': 'Gustavo A', 'Initials': 'GA', 'LastName': 'Angarita', 'Affiliation': 'Connecticut Mental Health Center, Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Siedlarz', 'Affiliation': 'Alcohol Research Center, Department of Psychiatry, University of Connecticut School of Medicine, Farmington, Connecticut.'}, {'ForeName': 'Rajita', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'The Yale Stress Center, Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut.'}]",The American journal on addictions,['10.1111/ajad.12828']
771,32440977,Persistence of Inflammation After Uncomplicated Cataract Surgery: A 6-Month Laser Flare Photometry Analysis.,"PURPOSE


To evaluate, by laser photometry, the persistency of anterior chamber flare after uneventful phacoemulsification in asymptomatic patients with no signs of inflammation on slit lamp examination.
METHOD


Seventy-five patients previously enrolled in a randomized clinical trial that evaluated inflammation after uneventful phacoemulsification in eyes treated with dexamethasone 0.1% ophthalmic suspension (group 1) or bromfenac 0.09% ophthalmic solution (group 2) for 2 weeks. Anterior chamber inflammation was investigated by laser flare photometry. At 30 days after surgery, laser flare showed persistently elevated values. For this reason, patients were further analyzed at 3 and 6 months. Additionally, optical coherence tomography was used to measure the central macular thickness (CMT) and to assess for postoperative pseudophakic macular edema.
RESULTS


When compared to preoperative values, laser flare photometry demonstrated persistent ocular inflammation at postoperative days 90 and 180 in group 1, but not in group 2. Laser flare values showed a significant reduction in group 2 compared to group 1 throughout all the follow-up (p < 0.001). The increase in mean CMT at days 90 and 180 with respect to baseline was statistically significant in group 1 but not in group 2, in which it decreased to levels similar to preoperative value. Group 1 showed a higher increase in mean CMT compared to group 2 throughout all the follow-up (p < 0.001). The proportion of patients that developed pseudophakic cystoid macular edema (CME) was 14% (n = 5) and 0% (n = 0) in group 1 and group 2, respectively (p = 0.02). The bivariate analysis demonstrated a positive correlation between laser flare and CMT values in group 1 but not in group 2.
CONCLUSION


Anterior chamber inflammation persists for more than 30 days in a significant proportion of patients after uncomplicated cataract surgery and may be responsible for late onset of cystoid macular edema cases.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT03317847.",2020,Laser flare values showed a significant reduction in group 2 compared to group 1 throughout all the follow-up (p < 0.001).,"['asymptomatic patients with no signs of inflammation on slit lamp examination', 'Seventy-five patients previously enrolled']","['dexamethasone 0.1% ophthalmic suspension (group\xa01) or bromfenac 0.09% ophthalmic solution', 'optical coherence tomography']","['Anterior chamber inflammation', 'central macular thickness (CMT', 'pseudophakic cystoid macular edema (CME', 'Persistence of Inflammation', 'ocular inflammation', 'Laser flare values', 'mean CMT']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}, {'cui': 'C4319621', 'cui_str': '75'}]","[{'cui': 'C0706574', 'cui_str': 'Dexamethasone 1 MG/ML Ophthalmic Suspension [Maxidex]'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C1562105', 'cui_str': 'Bromfenac (as bromfenac sodium) 900 microgram/mL eye solution'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]","[{'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0024440', 'cui_str': 'Cystoid macular edema'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",75.0,0.0199933,Laser flare values showed a significant reduction in group 2 compared to group 1 throughout all the follow-up (p < 0.001).,"[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'De Maria', 'Affiliation': 'Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Coassin', 'Affiliation': 'Ophthalmology, University Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Mastrofilippo', 'Affiliation': 'Clinical Trials and Statistics Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cimino', 'Affiliation': 'Ocular Immunology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Iannetta', 'Affiliation': 'Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Fontana', 'Affiliation': 'Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy. luifonta@gmail.com.'}]",Advances in therapy,['10.1007/s12325-020-01383-1']
772,32057470,New surgical instrument for the treatment of condylar fractures: the digitised condylar retractor.,"Reduction is one of the most difficult steps in condylar fracture surgery, and a key factor governing the postoperative outcome. In this study we evaluated quantitatively the effects of a digitised condylar retractor on the duration and rate of reduction. In a prospective, randomised, controlled clinical trial, 48 patients with unilateral condylar fractures who were listed for surgical treatment were randomised to an experimental and a control group (n=24 in each). The experimental group was treated with a digitised condylar retractor, and the control group with traditional surgical instruments only. The primary outcome variables were duration and rate of reduction. The continuity correction chi squared test and independent samples t test were used for statistical analyses. The results showed that the mean reduction time was 21.3minutes in the experimental group and 42.4minutes in the control group (p=2.48*10 -8 , <0.001). The reduction rate was 21/24 in the experimental group and 17/24 in the control group (p=0.16). The results indicated that the mean duration of reduction was significantly shorter, and the reduction rate was higher, in the experimental group than among controls. In conclusion, the digitised condylar retractor can assist surgeons to improve efficiency and accuracy in the reduction of condylar fractures, so it merits promotion as an aid to their surgical treatment.",2020,The reduction rate was 21/24 in the experimental group and 17/24 in the control group (p=0.16).,"['condylar fractures', '48 patients with unilateral condylar fractures who were listed for surgical treatment']","['digitised condylar retractor, and the control group with traditional surgical instruments only', 'digitised condylar retractor']","['duration and rate of reduction', 'mean reduction time', 'reduction rate', 'mean duration of reduction']","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0183014', 'cui_str': 'Retractor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0038928', 'cui_str': 'Surgical Instruments'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",48.0,0.0188266,The reduction rate was 21/24 in the experimental group and 17/24 in the control group (p=0.16).,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Dept. of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Dept. of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Dept. of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Dept. of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Dept. of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, PR China. Electronic address: drliulei@163.com.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2020.01.027']
773,32441031,Electrocautery Needling and the 308-nm Excimer Lamp: A Synergistic Combination for the Treatment of Stable Non-segmental Vitiligo.,"INTRODUCTION


Vitiligo is an acquired chronic depigmentation disorder caused by the destruction of melanocytes. Although various treatments have been proposed for the management of vitiligo, achieving repigmentation and preventing relapse remains challenging. The aim of the study was to evaluate the effectiveness of electrocautery needling (EC needling) as a treatment for stable non-segmental vitiligo and to determine if the effectiveness of this treatment could be enhanced by combining it with the 308-nm excimer lamp (excimer lamp).
METHODS


Thirty patients with stable non-segmental vitiligo were enrolled in this self-controlled, non-blinded study. Three vitiligo lesions of similar size, location and disease duration were selected from each patient and randomly assigned to one of three groups treated weekly with EC needling, an excimer lamp or a combination of both (combination group), respectively. The effectiveness of treatment on the repigmentation percentage and the number of treatments required for initial pigmentation were assessed.
RESULTS


There was no significant difference in the repigmentation percentage between the EC needling group and the excimer lamp group (P = 0.789). The mean number of treatments required for initial repigmentation was lower in the EC needling group than in the excimer lamp group (P = 0.049). The repigmentation percentage was significantly higher in the combination group than in the EC needling group (P = 0.027) and excimer lamp group (P = 0.005). Evidence of initial pigmentation was obtained earlier in lesions treated with the combination therapy than in lesions treated with excimer lamp therapy alone (P = 0.019). Vitiligo lesions on the face and neck regions showed the highest repigmentation percentage among all anatomical regions, whereas lesions on the hands and feet showed the worst treatment response.
CONCLUSION


Electrocautery needling monotherapy was effective in treating vitiligo, and its efficacy was enhanced when combined with the 308-nm excimer lamp. This combined approach to treat vitiligo is safe and helps increase patient compliance.",2020,There was no significant difference in the repigmentation percentage between the EC needling group and the excimer lamp group (P = 0.789).,"['Thirty patients with stable non-segmental vitiligo', 'Stable Non-segmental Vitiligo', 'stable non-segmental vitiligo']","['excimer lamp therapy', 'Electrocautery needling monotherapy', 'Electrocautery Needling and the 308-nm Excimer Lamp', 'excimer lamp', '308-nm excimer lamp (excimer lamp', 'electrocautery needling (EC needling', 'EC needling, an excimer lamp or a combination of both (combination group']","['repigmentation percentage', 'Vitiligo lesions', 'mean number of treatments required for initial repigmentation', 'initial pigmentation']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1274648', 'cui_str': 'Segmental vitiligo'}]","[{'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332121', 'cui_str': 'Treatment required for'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}]",30.0,0.0265379,There was no significant difference in the repigmentation percentage between the EC needling group and the excimer lamp group (P = 0.789).,"[{'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Dermatology, Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Pui Mun', 'Initials': 'PM', 'LastName': 'Wong', 'Affiliation': 'Department of Dermatology, Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lingli', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Pigmentation Research and Therapeutics, Graduate School of Medicine, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Katayama', 'Affiliation': 'Department of Pigmentation Research and Therapeutics, Graduate School of Medicine, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Huali', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of TCM Chemistry, School of Pharmacy, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai, China. zhanghm@shutcm.edu.cn.'}]",Dermatology and therapy,['10.1007/s13555-020-00395-7']
774,32441474,Impact of Combined Hormonal Contraceptive Use on Weight Loss: A Secondary Analysis of a Behavioral Weight-Loss Trial.,"OBJECTIVE


This study aimed to perform a preliminary investigation of the impact of combined hormonal contraceptive (CHC) use on weight loss during an 18-month behavioral weight-loss trial.
METHODS


Adults (n = 170; 18-55 years; BMI 27-42 kg/m 2  ) received a weight-loss intervention that included a reduced-calorie diet, a progressive exercise prescription, and group-based behavioral support. Premenopausal women (n = 110) were classified as CHC users (CHC, n = 17) or non-CHC users (non-CHC, n = 93). Changes in weight were examined within groups using a linear mixed model, adjusted for age and randomized group assignment.
RESULTS


At 6 M, weight was reduced from baseline in both CHC (mean, -6.7 kg; 95% CI: -9.8 to -3.7 kg) and non-CHC (-9.1 kg; -9.1 to -6.4 kg). Between 6 and 18 M, CHC regained weight (4.9 kg; 0.9 to 8.9 kg), while weight remained relatively unchanged in non-CHC (-0.1 kg; -1.8 to 1.6 kg). At 18 M, weight was relatively unchanged from baseline in CHC (-1.8 kg; -7.3 to 3.6 kg) and was reduced from baseline in non-CHC (-7.9 kg; -10.2 to -5.5 kg).
CONCLUSIONS


In this secondary data analysis, CHC use was associated with weight regain after initial weight loss. Prospective studies are needed to further understand the extent to which CHC use influences weight loss and maintenance.",2020,"At 6 M, weight was reduced from baseline in both CHC (mean, -6.7 kg; 95% CI: -9.8 to -3.7 kg) and non-CHC (-9.1 kg; -9.1 to -6.4 kg).","['Adults (n\u2009=\u2009170; 18-55 years; BMI 27-42 kg/m 2  ', 'Premenopausal women (n\u2009=\u2009110) were classified as CHC users (CHC, n\u2009=\u200917) or non-CHC users (non-CHC, n\u2009=\u200993']","['combined hormonal contraceptive (CHC', 'Combined Hormonal Contraceptive', 'weight-loss intervention that included a reduced-calorie diet, a progressive exercise prescription, and group-based behavioral support']","['weight regain', 'weight loss', 'CHC regained weight', 'Weight Loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0588464', 'cui_str': 'Exercise on prescription'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]",,0.0745885,"At 6 M, weight was reduced from baseline in both CHC (mean, -6.7 kg; 95% CI: -9.8 to -3.7 kg) and non-CHC (-9.1 kg; -9.1 to -6.4 kg).","[{'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Caldwell', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Adnin', 'Initials': 'A', 'LastName': 'Zaman', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Ostendorf', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Zhaoxing', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Department of Biostatistics and Informatics, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Bryan B', 'Initials': 'BB', 'LastName': 'Swanson', 'Affiliation': 'Department of Chemistry and Biochemistry, Colorado College, Colorado Springs, Colorado, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Phelan', 'Affiliation': 'Kinesiology and Public Health Department, California Polytechnic State University, San Luis Obispo, California, USA.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Wyatt', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Bessesen', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Catenacci', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22787']
775,32133871,Motivational factors for initiating and maintaining physical activity among adults aged over fifty targeted by a tailored intervention.,"Objective:  To provide insight into the motivational working mechanisms (i.e. mediators) of an effective physical activity (PA) intervention for adults aged over fifty. Design:  The mediation model ( N  = 822) was investigated in an RCT for the total intervention population, participants who were not norm-active at baseline (targeting PA initiation) and norm-active participants (targeting PA maintenance) separately. Main Outcome Measures:  Potential mediators (attitude, self-efficacy, intention, action planning and coping planning) of the effect on PA (6-months) were assessed at baseline, 3 and/or 6 months. Results:  The intervention resulted in a decrease in intention ( B = -.209;  p =.017), and an increase in action planning ( B =.214;  p =.018) and PA ( B =.220;  p =.002). Intention and action planning did not mediate the effect on PA. Self-efficacy, although not significantly influenced by the intervention, was found to be the only motivational variable that predicted change in PA ( B =.164;  p =.007). These results were confirmed among participants initiating PA. Among norm-active participants no significant intervention effects were identified. Conclusion:  The motivational factors cannot explain the intervention effect on PA. Most likely, the effect can be explained by an interaction between the motivational factors together. Differences between participants initiating versus maintaining PA, highlight the importance of performing mediation analyses per subgroup.",2020,"The intervention resulted in a decrease in intention ( B = -.209;  p =.017), and an increase in action planning ( B =.214;  p =.018) and PA ( B =.220;  p =.002).","['adults aged over fifty', 'adults aged over fifty targeted by a tailored intervention', 'participants who were not norm-active at baseline (targeting PA initiation) and norm-active participants (targeting PA maintenance) separately']",['physical activity (PA) intervention'],"['Potential mediators (attitude, self-efficacy, intention, action planning and coping planning) of the effect on PA (6-months', 'increase in action planning', 'Self-efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0462906,"The intervention resulted in a decrease in intention ( B = -.209;  p =.017), and an increase in action planning ( B =.214;  p =.018) and PA ( B =.220;  p =.002).","[{'ForeName': 'Denise Astrid', 'Initials': 'DA', 'LastName': 'Peels', 'Affiliation': 'Department of Psychology, Open University, Heerlen, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Verboon', 'Affiliation': 'Department of Psychology, Open University, Heerlen, Netherlands.'}, {'ForeName': 'Maartje M', 'Initials': 'MM', 'LastName': 'van Stralen', 'Affiliation': 'Faculty of Science, Prevention and Public Health, Amsterdam Public Health Research Institute, VU University, Amsterdam, Netherlands.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bolman', 'Affiliation': 'Department of Psychology, Open University, Heerlen, Netherlands.'}, {'ForeName': 'Rianne H J', 'Initials': 'RHJ', 'LastName': 'Golsteijn', 'Affiliation': 'Department of Psychology, Open University, Heerlen, Netherlands.'}, {'ForeName': 'Aart N', 'Initials': 'AN', 'LastName': 'Mudde', 'Affiliation': 'Department of Psychology, Open University, Heerlen, Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'de Vries', 'Affiliation': 'Department of Health Promotion, Maastricht University Medical Centre+, Maastricht, Netherlands.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Lechner', 'Affiliation': 'Department of Psychology, Open University, Heerlen, Netherlands.'}]",Psychology & health,['10.1080/08870446.2020.1734202']
776,32139216,Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement: Results From the DIRECTAVI Trial.,"OBJECTIVES


The aim of this study was to evaluate device success of transcatheter aortic valve replacement (TAVR) using new-generation balloon-expandable prostheses with or without balloon aortic valvuloplasty (BAV).
BACKGROUND


Randomized studies are lacking comparing TAVR without BAV against the conventional technique of TAVR with BAV.
METHODS


DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) was an open-label noninferiority study that randomized patients undergoing TAVR using the Edwards SAPIEN 3 valve with or without prior balloon valvuloplasty. The primary endpoint was the device success rate according to Valve Academic Research Consortium-2 criteria, which was evaluated using a 7% noninferiority margin. The secondary endpoint included procedural and 30-day adverse events.
RESULTS


Device success was recorded for 184 of 236 included patients (78.0%). The rate of device success in the direct implantation group (n = 97 [80.2%]) was noninferior to that in the BAV group (n = 87 [75.7%]) (mean difference 4.5%; 95% confidence interval: -4.4% to 13.4%; p = 0.02 for noninferiority). No severe prosthesis-patient mismatch or severe aortic regurgitation occurred in any group. In the direct implantation group, 7 patients (5.8%) required BAV to cross the valve. Adverse events were related mainly to pacemaker implantation (20.9% in the BAV group vs. 19.0% in the direct implantation group; p = 0.70). No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation.
CONCLUSIONS


Direct TAVR without prior BAV was noninferior to the conventional strategy using BAV with new-generation balloon-expandable valves, but without procedural simplification. BAV was needed to cross the valve in a few patients, suggesting a need for upstream selection on the basis of patient anatomy. (TAVI Without Balloon Predilatation [of the Aortic Valve] SAPIEN 3 [DIRECTAVI]; NCT02729519).",2020,"No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation.
",['randomized patients undergoing TAVR using the Edwards SAPIEN 3 valve with or without prior balloon valvuloplasty'],"['new-generation balloon-expandable prostheses with or without balloon aortic valvuloplasty (BAV', 'TAVI Without Balloon Predilatation [of the Aortic Valve', 'transcatheter aortic valve replacement (TAVR', 'Transcatheter Aortic Valve Implantation', 'Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement']","['device success rate according to Valve Academic Research Consortium-2 criteria', 'BAV to cross the valve', 'Device success', 'BAV', 'Adverse events', 'procedural and 30-day adverse events', 'severe prosthesis-patient mismatch or severe aortic regurgitation', 'rate of device success', 'duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0004708', 'cui_str': 'Balloon Valvotomy'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0396949', 'cui_str': 'Valvuloplasty of aortic valve (procedure)'}, {'cui': 'C3509486', 'cui_str': 'Transcatheter Aortic Valve Implantation'}, {'cui': 'C0003501', 'cui_str': 'Aortic Valve'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0004708', 'cui_str': 'Balloon Valvotomy'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0035168'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003504', 'cui_str': 'Aortic Incompetence'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation (event)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]",236.0,0.0744625,"No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation.
","[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Leclercq', 'Affiliation': 'Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France. Electronic address: f-leclercq@chu-montpellier.fr.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Robert', 'Affiliation': 'Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France.'}, {'ForeName': 'Mariama', 'Initials': 'M', 'LastName': 'Akodad', 'Affiliation': 'Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France; PhyMedExp, INSERM U1046, CNRS UMR 9214, Montpellier, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Macia', 'Affiliation': 'Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gandet', 'Affiliation': 'Department of Cardiovascular Surgery, University Hospital of Montpellier, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Delseny', 'Affiliation': 'Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Chettouh', 'Affiliation': 'Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Schmutz', 'Affiliation': 'Department of Cardiology, CHU Nimes, Montpellier University, Nimes, France.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Robert', 'Affiliation': 'St. Pierre Clinic, Perpignan, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Levy', 'Affiliation': 'Millenaire Clinic, Montpellier, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Targosz', 'Affiliation': 'Perpignan Hospital, Perpignan, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Maupas', 'Affiliation': 'Franciscaines Clinic, Nimes, France.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': 'Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France; PhyMedExp, INSERM U1046, CNRS UMR 9214, Montpellier, France.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Marin', 'Affiliation': 'Department of Medical Information, University Hospital of Montpellier, Montpellier, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Nagot', 'Affiliation': 'Department of Medical Information, University Hospital of Montpellier, Montpellier, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Albat', 'Affiliation': 'Department of Cardiovascular Surgery, University Hospital of Montpellier, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lattuca', 'Affiliation': 'Department of Cardiology, CHU Nimes, Montpellier University, Nimes, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': 'Department of Cardiology, CHU Nimes, Montpellier University, Nimes, France.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.12.006']
777,32437664,"First-line pembrolizumab and trastuzumab in HER2-positive oesophageal, gastric, or gastro-oesophageal junction cancer: an open-label, single-arm, phase 2 trial.","BACKGROUND


Addition of trastuzumab to first-line chemotherapy improves overall survival in patients with HER2-positive metastatic gastric cancer. We assessed the safety and activity of pembrolizumab in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic oesophagogastric (gastric, oesophageal, or gastroesophageal junction) cancer.
METHODS


This study was an investigator-initiated, open-label, non-randomised, single-arm, single centre, phase 2 trial in patients aged 18 years or older with HER2-positive metastatic oesophagogastric cancer. Eligible patients had measurable or evaluable non-measurable disease, Eastern Cooperative Oncology Group performance status of 0, 1, or 2, and left ventricular ejection fraction of at least 53%. Patients were eligible to receive an initial induction cycle of 200 mg flat dose of intravenous pembrolizumab and 8 mg/kg loading dose of intravenous trastuzumab. For subsequent cycles, patients received 130 mg/m 2  of intravenous oxaliplatin or 80 mg/m 2  of cisplatin on day 1, 850 mg/m 2  of oral capecitabine twice a day for 2 weeks followed by 1 week off (or intravenous 5-fluorouracil, 800 mg/m 2  per day on days 1-5), and a 200 mg flat dose of intravenous pembrolizumab, and 6 mg/kg of trastuzumab, administered on day 1 of each 3-week cycle. The primary endpoint was 6-month progression-free survival, defined as the proportion of patients alive and free of progression at 6 months, assessed in patients who received at least one dose of trastuzumab and pembrolizumab. The regimen would be considered worthy of further investigation if 26 or more of 37 patients were progression-free at 6 months. This trial is registered with ClinicalTrials.gov, NCT02954536, and is ongoing, but closed to enrolment.
FINDINGS


Between Nov 11, 2016, and Jan 23, 2019, 37 patients were enrolled. At the time of data cutoff on Aug 6, 2019, median follow-up among survivors was 13·0 months (IQR 11·7-23·5). The primary endpoint was achieved; 26 (70%; 95% CI 54-83) of 37 patients were progression-free at 6 months. The most common treatment-related adverse event of any grade was neuropathy, which was reported in 36 (97%) of 37 patients. The most common grade 3 or 4 adverse events were lymphocytopenia (seven [19%] patients with grade 3 and two [5%] with grade 4), grade 3 decreased electrolytes (six [16%] patients), and grade 3 anaemia (four [11%] patients). Serious adverse events occurred in two patients patients (both grade 3 nephritis leading to treatment discontinuation). Four patients discontinued pembrolizumab because of immune-related adverse events. There were no treatment-related deaths.
INTERPRETATION


Pembrolizumab can be safely combined with trastuzumab and chemotherapy and has promising activity in HER2-positive metastatic oesophagogastric cancer. A randomised phase 3 clinical trial assessing the efficacy and safety of pembrolizumab versus placebo in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic oesophagogastric cancer is underway.
FUNDING


Merck & Co.",2020,The primary endpoint was achieved; 26 (70%; 95% CI 54-83) of 37 patients were progression-free at 6 months.,"['HER2-positive metastatic oesophagogastric cancer', 'Eligible patients had measurable or evaluable non-measurable disease, Eastern Cooperative Oncology Group performance status of 0, 1, or 2, and left ventricular ejection fraction of at least 53', 'patients aged 18 years or older with HER2-positive metastatic oesophagogastric cancer', 'first-line HER2-positive metastatic oesophagogastric cancer', 'HER2-positive oesophageal, gastric, or gastro-oesophageal junction cancer', 'Between Nov 11, 2016, and Jan 23, 2019, 37 patients were enrolled', 'first-line HER2-positive metastatic oesophagogastric (gastric, oesophageal, or gastroesophageal junction) cancer', 'patients with HER2-positive metastatic gastric cancer']","['oxaliplatin', 'intravenous pembrolizumab and 8 mg/kg loading dose of intravenous trastuzumab', 'trastuzumab and pembrolizumab', 'trastuzumab to first-line chemotherapy', 'trastuzumab and chemotherapy', 'capecitabine', 'cisplatin', 'pembrolizumab, and 6 mg/kg of trastuzumab', 'pembrolizumab versus placebo', 'First-line pembrolizumab and trastuzumab', '5-fluorouracil', 'pembrolizumab']","['safety and activity', '6-month progression-free survival, defined as the proportion of patients alive and free of progression', 'overall survival', 'grade 3 decreased electrolytes', 'grade 3 anaemia', 'efficacy and safety', 'Serious adverse events']","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0278498', 'cui_str': 'Gastric cancer stage IV'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0740464', 'cui_str': 'Electrolytes NOS decreased'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",37.0,0.193351,The primary endpoint was achieved; 26 (70%; 95% CI 54-83) of 37 patients were progression-free at 6 months.,"[{'ForeName': 'Yelena Y', 'Initials': 'YY', 'LastName': 'Janjigian', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA. Electronic address: janjigiy@mskcc.org.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Maron', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Walid K', 'Initials': 'WK', 'LastName': 'Chatila', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Tri-Institutional Program in Computational Biology and Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Brittanie', 'Initials': 'B', 'LastName': 'Millang', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Shweta S', 'Initials': 'SS', 'LastName': 'Chavan', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Alterman', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Joanne F', 'Initials': 'JF', 'LastName': 'Chou', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Michal F', 'Initials': 'MF', 'LastName': 'Segal', 'Affiliation': 'Department of Nursing, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marc Z', 'Initials': 'MZ', 'LastName': 'Simmons', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Momtaz', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Shcherba', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Geoffrey Y', 'Initials': 'GY', 'LastName': 'Ku', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Zervoudakis', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Won', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Kelsen', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Ilson', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Nagy', 'Affiliation': 'Guardant Health, Redwood City, CA, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lanman', 'Affiliation': 'Guardant Health, Redwood City, CA, USA.'}, {'ForeName': 'Ryan N', 'Initials': 'RN', 'LastName': 'Ptashkin', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mark T A', 'Initials': 'MTA', 'LastName': 'Donoghue', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marinela', 'Initials': 'M', 'LastName': 'Capanu', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Taylor', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Solit', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Schultz', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jaclyn F', 'Initials': 'JF', 'LastName': 'Hechtman', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30169-8']
778,32495208,Willingness to enroll in a surgical randomized controlled trial: patient and parent preferences regarding implant density for adolescent idiopathic scoliosis fusion.,"STUDY DESIGN


Prospective survey of adolescent idiopathic scoliosis (AIS) patients/parents with surgical magnitude curves.
OBJECTIVE


We hypothesized that patients and families considering fusion surgery would be willing to enroll in a randomized controlled trial (RCT) evaluating the effect of number of implants on curve correction. Surgical RCTs are infrequently performed, particularly in a pediatric population. Parental willingness to enroll affects both study design and trial feasibility. The Minimize Implants Maximize Outcomes (MIMO) Clinical Trial proposes to randomize patients to more versus fewer screws (high or low density) for Lenke 1A curve patterns, but it is unclear whether families and patients are willing to enroll in such a trial.
METHODS


This study was undertaken at 4 of the 14 sites participating in the MIMO Clinical Trial. AIS patients with Cobb > 45° were included. Implant density is defined as screws per level fused. Patients and families reviewed the MIMO education module describing proposed advantages and disadvantages of high (> 1.8) vs. low (< 1.4) density screw constructs and completed a custom survey regarding their preferences about the trial.
RESULTS


159 individuals were surveyed (78 families), including 82 parents/guardians, and 77 patients. Of those surveyed, 95% mostly or completely understood the trial (range 47-78%), and 63% agreed to enroll. Parents and patients who completely understood the trial were significantly more likely to enroll.
CONCLUSION


Randomization in the MIMO Trial was acceptable to the majority (63%) of patients and parents. Clear patient and parent education materials and access to the surgeon may facilitate enrollment in the trial. Parents afforded the child much autonomy when considering enrollment, although most families agree both child and parent should be in agreement before entering the trial.
LEVEL OF EVIDENCE


II.",2020,"Parents and patients who completely understood the trial were significantly more likely to enroll.
","['adolescent idiopathic scoliosis fusion', '14 sites participating in the MIMO Clinical Trial', 'adolescent idiopathic scoliosis (AIS) patients/parents with surgical magnitude curves', 'patients and families considering fusion surgery', '159 individuals were surveyed (78 families), including 82 parents/guardians, and 77 patients', 'AIS patients with Cobb\u2009>\u200945° were included']",[],"['Minimize Implants Maximize Outcomes (MIMO', 'Implant density']","[{'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}]",[],"[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",159.0,0.204835,"Parents and patients who completely understood the trial were significantly more likely to enroll.
","[{'ForeName': 'A Noelle', 'Initials': 'AN', 'LastName': 'Larson', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. larson.noelle@mayo.edu.'}, {'ForeName': 'Lorena V', 'Initials': 'LV', 'LastName': 'Floccari', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Sumeet', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': ""Children's Hospital Colorado, Aurora, CO, USA.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Erickson', 'Affiliation': ""Children's Hospital Colorado, Aurora, CO, USA.""}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Sponseller', 'Affiliation': 'Johns Hopkin University, Baltimore, MD, USA.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Brito', 'Affiliation': 'Mayo Clinic Shared Decision Making National Resource Center, Mayo Clinic, Rochester, USA.'}, {'ForeName': 'Carl-Eric', 'Initials': 'CE', 'LastName': 'Aubin', 'Affiliation': 'Polytechnique Montreal, Montreal, QC, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Polly', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Spine deformity,['10.1007/s43390-020-00143-z']
779,31427751,"Effects of immunomodulatory drugs on depressive symptoms: A mega-analysis of randomized, placebo-controlled clinical trials in inflammatory disorders.","Activation of the innate immune system is commonly associated with depression. Immunomodulatory drugs may have efficacy for depressive symptoms that are co-morbidly associated with inflammatory disorders. We report a large-scale re-analysis by standardized procedures (mega-analysis) of patient-level data combined from 18 randomized clinical trials conducted by Janssen or GlaxoSmithKline for one of nine disorders (N = 10,743 participants). Core depressive symptoms (low mood, anhedonia) were measured by the Short Form Survey (SF-36) or the Hospital Anxiety and Depression Scale (HADS), and participants were stratified into high (N = 1921) versus low-depressive strata based on baseline ratings. Placebo-controlled change from baseline after 4-16 weeks of treatment was estimated by the standardized mean difference (SMD) over all trials and for each subgroup of trials targeting one of 7 mechanisms (IL-6, TNF-α, IL-12/23, CD20, COX2, BLγS, p38/MAPK14). Patients in the high depressive stratum showed modest but significant effects on core depressive symptoms (SMD = 0.29, 95% CI [0.12-0.45]) and related SF-36 measures of mental health and vitality. Anti-IL-6 antibodies (SMD = 0.8, 95% CI [0.20-1.41]) and an anti-IL-12/23 antibody (SMD = 0.48, 95% CI [0.26-0.70]) had larger effects on depressive symptoms than other drug classes. Adjustments for physical health outcome marginally attenuated the average treatment effect on depressive symptoms (SMD = 0.20, 95% CI: 0.06-0.35), but more strongly attenuated effects on mental health and vitality. Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment. Novel immune-therapeutics can produce antidepressant effects in depressed patients with primary inflammatory disorders that are not entirely explained by treatment-related changes in physical health.",2020,Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment.,"['depressed patients with primary inflammatory disorders', 'for one of nine disorders (N\u2009=\u200910,743 participants']","['Placebo', 'placebo', 'immunomodulatory drugs', 'Janssen or GlaxoSmithKline']","['depressive symptoms', 'Anti-IL-6 antibodies', 'mental health and vitality', 'core depressive symptoms', 'related SF-36 measures of mental health and vitality', 'Core depressive symptoms (low mood, anhedonia', 'Hospital Anxiety and Depression Scale (HADS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1290884', 'cui_str': 'Inflammatory disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}]",,0.398153,Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment.,"[{'ForeName': 'Gayle M', 'Initials': 'GM', 'LastName': 'Wittenberg', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA. gwittenb@its.jnj.com.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Stylianou', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Bangalore, India.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Jagannatha', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Bangalore, India.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hsu', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Curran', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'ImmunoPsychiatry, Immuno-Inflammation Therapeutic Area Unit, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, La Jolla, CA, USA.'}, {'ForeName': 'Edward T', 'Initials': 'ET', 'LastName': 'Bullmore', 'Affiliation': 'ImmunoPsychiatry, Immuno-Inflammation Therapeutic Area Unit, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, La Jolla, CA, USA.'}]",Molecular psychiatry,['10.1038/s41380-019-0471-8']
780,32495381,Randomized controlled trial of multi-modular motion-assisted memory desensitization and reconsolidation (3MDR) for male military veterans with treatment-resistant post-traumatic stress disorder.,"OBJECTIVE


To explore the potential efficacy of multi-modular motion-assisted memory desensitization and reprocessing (3MDR) in British military veterans with treatment-resistant service-related PTSD.
METHODS


Exploratory single-blind, randomized, parallel arm, cross-over controlled trial with nested process evaluation to assess fidelity, adherence and factors that influence outcome.
RESULTS


A total of 42 participants (all male) were randomized with 83% retention at 12 weeks and 86% at 26 weeks. The difference in mean Clinician-Administered PTSD Scale for DSM-5 scores between the immediate and delayed 3MDR arms was -9.38 (95% CI -17.33 to -1.44, P = 0.021) at 12 weeks and -3.59 (-14.39 to 7.20, P = 0.513) at 26 weeks when both groups had received 3MDR. The likely effect size of 3MDR was found to be 0.65. Improvements were maintained at 26-week follow-up. 3MDR was found to be acceptable to most, but not all, participants. Several factors that may impact efficacy and acceptability of 3MDR were identified.
CONCLUSION


3MDR is a promising new intervention for treatment-resistant PTSD with emerging evidence of effect.",2020,"(-14.39 to 7.20, p= 0.513) at 26 weeks when both groups had received 3MDR.","['male military veterans with treatment-resistant post-traumatic stress disorder', 'British military veterans with treatment-resistant, service-related PTSD', '42 participants (all male']","['multi-modular motion-assisted memory desensitisation and reconsolidation (3MDR', 'multi-modular motion-assisted memory desensitisation and reprocessing (3MDR', '3MDR']","['3MDR', 'mean Clinician Administered PTSD Scale for DSM-5 scores']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.133104,"(-14.39 to 7.20, p= 0.513) at 26 weeks when both groups had received 3MDR.","[{'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Bisson', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'van Deursen', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hannigan', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kitchiner', 'Affiliation': ""Veterans' NHS Wales, Cardiff and Vale University Health Board, Cardiff, UK.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Barawi', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pickles', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Skipper', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Young', 'Affiliation': 'Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Abbott', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Gelderen', 'Affiliation': 'Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Nijdam', 'Affiliation': ""ARQ Centrum'45, ARQ National Psychotrauma Centre, Diemen, The Netherlands.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Vermetten', 'Affiliation': 'Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13200']
781,32496203,Feasibility and Acceptability of a Text Message-Based Intervention to Reduce Overuse of Alcohol in Emergency Department Patients: Controlled Proof-of-Concept Trial.,"BACKGROUND


Emergency department (ED) patients have high rates of risky alcohol use, and an ED visit offers an opportunity to intervene. ED-based screening, brief intervention, and referral to treatment (SBIRT) reduces alcohol use and health care costs. Mobile health (mHealth) interventions may expand the impact of SBIRTs but are understudied in low-resource ED populations.
OBJECTIVE


The objective of this study was to assess the feasibility of and patient satisfaction with a text-based mHealth extension of an ED screening program to reduce risky alcohol use in low-income, urban patients.
METHODS


Research assistants screened a convenience sample of ED patients in person for risky alcohol use via the Alcohol Use Disorders Identification Test (AUDIT). Patients who reported AUDIT scores ≥8 and <20 were informed of their AUDIT score and risk. RAs invited patients with SMS text message-capable phones to receive mROAD (mobilizing to Reduce Overuse of Alcohol in the ED), an SMS text message-based extension of the ED screening program. mROAD is a 7-day program of twice-daily SMS text messages based on the National Institutes of Health's Rethinking Drinking campaign. Participants were allocated to a control group (daily sham text messages without specific guidance on behaviors, such as ""Thanks for taking part!"") or to the mROAD intervention group. Patients were interviewed at 30 days to assess acceptability, satisfaction, and changes in drinking behavior. Satisfaction was examined descriptively. Pre and post measurements of drinking behaviors and motivation were compared, as were differences in change scores between the intervention arms.
RESULTS


Of 1028 patients screened, 95 (9.2%) exhibited risky alcohol use based on AUDIT, and 23/95 (24%) of those patients did not own an SMS text messaging-capable phone; this left 72/95 (76%) eligible patients. Among eligible participants, 48/72 (67%) agreed to enroll; 31/48 (65%) achieved follow-up (18/24 (75%) in the intervention group and 13/24 (55%) in the control group). Participants who completed follow-up reported high satisfaction. Changes in behavior were similar between the arms. Overall, the number of drinking days reported in the prior 30 days decreased by 5.0 (95% CI 1.7-8.3; P=.004), and the number of heavy drinking days decreased by 4.1 (95% CI 1.0 to 7.15, P=.01). Patients reported an 11-point increase (95% CI 2.6-20, P=.01, 10% overall increase) in motivation to change alcohol use via the Change Questionnaire. The were no statistical differences in drinking days, heavy drinking days, or motivation to change between the arms.
CONCLUSIONS


The mROAD trial was feasible. Over three-quarters of ED patients with risky alcohol use owned a text message-capable phone, and two-thirds of these patients were willing to participate; only 1 patient opted out of the intervention. Although 35% of patients were lost to follow-up at 30 days, those patients who did follow up had favorable impressions of the program; more than 90% reported that SMS text messages were a ""good way to teach,"" and 89% of intervention arm participants enjoyed the program and found that the messages were motivating. Both the mROAD and sham message groups showed promising changes in alcohol use and motivation to change. mROAD is a feasible intervention that may reduce rates of risky alcohol use in ED patients.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02158949; https://clinicaltrials.gov/ct2/show/NCT02158949.",2020,"Patients reported an 11-point increase (95% CI 2.6-20, P=.01, 10% overall increase) in motivation to change alcohol use via the Change Questionnaire.","['Research assistants screened a convenience sample of ED patients in person for risky alcohol use via the Alcohol Use Disorders Identification Test (AUDIT', 'ED patients', 'low-income, urban patients', 'Emergency Department Patients', '1028 patients screened, 95 (9.2%) exhibited risky alcohol use based on AUDIT, and 23/95 (24%) of those patients did not own an SMS text messaging-capable phone; this left 72/95 (76%) eligible patients']","['Text Message-Based Intervention', 'text-based mHealth extension of an ED screening program', 'Mobile health (mHealth) interventions', 'control group (daily sham text messages without specific guidance on behaviors, such as ""Thanks for taking part!"") or to the mROAD intervention group']","['drinking behaviors and motivation', 'Changes in behavior', 'drinking days, heavy drinking days, or motivation to change between the arms', 'acceptability, satisfaction, and changes in drinking behavior', 'Satisfaction', 'number of drinking days', 'number of heavy drinking days']","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0205091', 'cui_str': 'Left'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.101456,"Patients reported an 11-point increase (95% CI 2.6-20, P=.01, 10% overall increase) in motivation to change alcohol use via the Change Questionnaire.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Burner', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Terp', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ford Bench', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Chun Nok', 'Initials': 'CN', 'LastName': 'Lam', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Jesus R', 'Initials': 'JR', 'LastName': 'Torres', 'Affiliation': 'School of Medicine, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Menchine', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}]",JMIR mHealth and uHealth,['10.2196/17557']
782,31423712,"Safety, Tolerability and efficacy of Rapid Optimization, helped by NT-proBNP and GDF-15, of Heart Failure therapies (STRONG-HF): rationale and design for a multicentre, randomized, parallel-group study.","AIMS


Patients admitted for acute heart failure (HF) are at high risk of readmission and death, especially in the 90 days following discharge. We aimed to assess the safety and efficacy of early optimization of oral HF therapy with beta-blockers (BB), angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) or angiotensin receptor-neprilysin inhibitors (ARNi), and mineralocorticoid receptor antagonists (MRA) on 90-day clinical outcomes in patients admitted for acute HF.
METHODS


In a multicentre, randomized, open-label, parallel-group study, a total of 900 patients will be randomized in a 1:1 ratio to either 'usual care' or 'high-intensity care'. Patients enrolled in the usual care arm will be discharged and managed according to usual clinical practice at the site. In the high-intensity care arm, doses of oral HF medications - including a BB, ACEi or ARB, and MRA - will be up-titrated to 50% of recommended doses before discharge and to 100% of recommended doses within 2 weeks of discharge. Up-titration will be delayed if the patients develop worsening symptoms and signs of congestion, hyperkalaemia, hypotension, bradycardia, worsening of renal function or significant increase in N-terminal pro-B-type natriuretic peptide between visits. The primary endpoint is 90-day all-cause mortality or HF readmission.
CONCLUSIONS


STRONG-HF is the first study to assess whether rapid up-titration of evidence-based guideline-recommended therapies with close follow-up in a large cohort of patients discharged from an acute HF admission is safe and can affect adverse outcomes during the first 90 days after discharge.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT03412201.",2019,"Up-titration will be delayed if the patients develop worsening symptoms and signs of congestion, hyperkalaemia, hypotension, bradycardia, worsening of renal function or significant increase in N-terminal pro-B-type natriuretic peptide between visits.","[""900 patients will be randomized in a 1:1 ratio to either 'usual care' or 'high-intensity care"", 'patients admitted for acute HF', 'Patients admitted for acute heart failure (HF', 'Patients enrolled in the usual care arm will be discharged and managed according to usual clinical practice at the site']","['oral HF therapy with beta-blockers (BB), angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) or angiotensin receptor-neprilysin inhibitors (ARNi), and mineralocorticoid receptor antagonists (MRA']","['90-day all-cause mortality or HF readmission', 'Safety, Tolerability and efficacy', 'safety and efficacy']","[{'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}, {'cui': 'C0025250', 'cui_str': 'CALLA Antigen'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",900.0,0.0977579,"Up-titration will be delayed if the patients develop worsening symptoms and signs of congestion, hyperkalaemia, hypotension, bradycardia, worsening of renal function or significant increase in N-terminal pro-B-type natriuretic peptide between visits.","[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Kimmoun', 'Affiliation': 'INSERM UMR-S 942, St. Louis and Lariboisère University Hospitals, Paris University, Paris, France.'}, {'ForeName': 'Gad', 'Initials': 'G', 'LastName': 'Cotter', 'Affiliation': 'Momentum Research Inc., Durham, NC, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Davison', 'Affiliation': 'Momentum Research Inc., Durham, NC, USA.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Takagi', 'Affiliation': 'INSERM UMR-S 942, St. Louis and Lariboisère University Hospitals, Paris University, Paris, France.'}, {'ForeName': 'Faouzi', 'Initials': 'F', 'LastName': 'Addad', 'Affiliation': 'Department of Cardiology, Abderrahmen Mami University hospital, Ariana, Tunisia.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Celutkiene', 'Affiliation': 'Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Chioncel', 'Affiliation': ""Emergency Institute for Cardiovascular Diseases 'Prof. C.C. Iliescu', University of Medicine 'Carol Davila', Bucharest, Romania.""}, {'ForeName': 'Alain Cohen', 'Initials': 'AC', 'LastName': 'Solal', 'Affiliation': 'INSERM UMR-S 942, St. Louis and Lariboisère University Hospitals, Paris University, Paris, France.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina.'}, {'ForeName': 'Albertino', 'Initials': 'A', 'LastName': 'Damasceno', 'Affiliation': 'Eduardo Mondlane University Hospital, Maputo, Mozambique.'}, {'ForeName': 'Hans-Dirk', 'Initials': 'HD', 'LastName': 'Duengen', 'Affiliation': 'Department of Internal Medicine - Cardiology, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'Heart Failure Unit, Attikon University Hospital, National and Kapodistrian University of Athens, Greece; School of Medicine, University of Cyprus, Nicosia, Cyprus.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Goncalvesova', 'Affiliation': 'Department of Heart Failure and Transplantation, National Institute of Cardiovascular Diseases, Bratislava, Slovak Republic.'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Merai', 'Affiliation': 'Cardiac Care Unit, Moscow City Hospital, Moscow, Russia.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Privalov', 'Affiliation': 'Critical Cardiac Unit, City Clinical Hospital, Moscow, Russia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sliwa', 'Affiliation': 'Division of Cardiology, Department of Medicine, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mahmoud Umar', 'Initials': 'MU', 'LastName': 'Sani', 'Affiliation': 'Department of Medicine, Bayero University Kano, Kano, Nigeria.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Zaur', 'Initials': 'Z', 'LastName': 'Shogenov', 'Affiliation': 'Moscow SHI, City Clinical Hospital, Moscow, Russia.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mebazaa', 'Affiliation': 'INSERM UMR-S 942, St. Louis and Lariboisère University Hospitals, Paris University, Paris, France.'}]",European journal of heart failure,['10.1002/ejhf.1575']
783,31412001,Cost-effectiveness of Pembrolizumab as Second-line Therapy for the Treatment of Locally Advanced or Metastatic Urothelial Carcinoma in Sweden.,"BACKGROUND


Urothelial carcinoma (UC) is the most common subtype of bladder cancer. The randomized phase 3 KEYNOTE-045 trial showed that pembrolizumab, used as second-line therapy significantly prolonged overall survival with fewer treatment-related adverse events than chemotherapy for advanced UC. Pembrolizumab has been approved by the European Medicines Agency for the treatment of locally advanced or metastatic UC in adults who have received platinum-containing chemotherapy. Many European countries use cost-effectiveness analysis to inform reimbursement decisions.
OBJECTIVE


To assess the cost-effectiveness of pembrolizumab as second-line therapy for the treatment of advanced UC from a Swedish health care perspective.
DESIGN, SETTING, AND PARTICIPANTS


We developed a partitioned-survival model to assess the costs and effectiveness of pembrolizumab compared with vinflunine (base case), paclitaxel, or docetaxel monotherapy in patients with advanced UC over a 15-yr time horizon. We obtained Kaplan-Meier estimates for survival endpoints, adverse events, and utility data from KEYNOTE-045.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


We performed parametric extrapolations to estimate overall and progression-free survival beyond the clinical trial period. Swedish costs and utility weights were used to estimate total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). We performed deterministic and probabilistic sensitivity analyses to assess the robustness of the model results.
RESULTS AND LIMITATIONS


In the base-case analysis, pembrolizumab resulted in a mean survival gain of 1.66 years (1.38 QALYs) at an incremental cost of €69852 and an ICER of €50529/QALY gained versus vinflunine monotherapy. ICERs for other chemotherapies were €81356/QALY for pembrolizumab versus paclitaxel or docetaxel monotherapy, and €71924/QALY for pembrolizumab versus paclitaxel, docetaxel, or vinflunine monotherapy. Long-term follow-up from KEYNOTE-045 and real-world data are needed to validate the extrapolations.
CONCLUSIONS


The results indicate that pembrolizumab improves survival, increases QALYs, and is cost-effective as second-line therapy at a willingness-to-pay threshold of €100000/QALY for the treatment of advanced UC.
PATIENT SUMMARY


To date, pembrolizumab is the only treatment associated with a significant overall survival benefit compared with chemotherapy in a randomized controlled trial as second-line therapy for advanced urothelial carcinoma. Our trial-based cost-effectiveness analysis suggests that pembrolizumab is a cost-effective option over chemotherapy in patients with advanced urothelial carcinoma after platinum-based therapy in Sweden.",2020,"In the base-case analysis, pembrolizumab resulted in a mean survival gain of 1.66 years (1.38 QALYs) at an incremental cost of €69852 and an ICER of €50529/QALY gained versus vinflunine monotherapy.","['Urothelial carcinoma (UC', 'patients with advanced UC over a 15-yr time horizon', 'locally advanced or metastatic UC in adults who have received platinum-containing chemotherapy', 'advanced urothelial carcinoma', 'advanced UC from a Swedish health care perspective', 'patients with advanced urothelial carcinoma after platinum-based therapy in Sweden', 'Locally Advanced or Metastatic Urothelial Carcinoma in Sweden']","['Pembrolizumab', 'pembrolizumab', 'pembrolizumab versus paclitaxel, docetaxel, or vinflunine monotherapy', 'Pembrolizumab as Second-line Therapy', 'pembrolizumab versus paclitaxel or docetaxel monotherapy', 'vinflunine (base case), paclitaxel, or docetaxel monotherapy', 'chemotherapy']","['Swedish costs and utility weights', 'overall survival', 'survival, increases QALYs, and is cost-effective', 'mean survival gain', 'cost-effectiveness', 'total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs']","[{'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0672663', 'cui_str': 'vinflunine'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.10683,"In the base-case analysis, pembrolizumab resulted in a mean survival gain of 1.66 years (1.38 QALYs) at an incremental cost of €69852 and an ICER of €50529/QALY gained versus vinflunine monotherapy.","[{'ForeName': 'Tushar', 'Initials': 'T', 'LastName': 'Srivastava', 'Affiliation': 'Complete HEOR Solutions, North Wales, PA, USA.'}, {'ForeName': 'Vimalanand S', 'Initials': 'VS', 'LastName': 'Prabhu', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Haojie', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Ruifeng', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Zarabi', 'Affiliation': 'Merck Sharp & Dohme, Stockholm, Sweden.'}, {'ForeName': 'Yichen', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA. Electronic address: yichen.zhong@merck.com.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Pellissier', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Rodolfo F', 'Initials': 'RF', 'LastName': 'Perini', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'de Wit', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Ronac', 'Initials': 'R', 'LastName': 'Mamtani', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}]",European urology oncology,['10.1016/j.euo.2018.09.012']
784,31411972,Internal and External Validation of a 90-Day Percentage Erection Fullness Score Model Predicting Potency Recovery Following Robot-assisted Radical Prostatectomy.,"BACKGROUND


We previously reported a new post-radical prostatectomy (RP) prediction model for men with normal baseline erectile function (EF) using 90-d postoperative erection fullness to identify men who might benefit from early EF rehabilitation.
OBJECTIVE


To prospectively internally and externally validate the use of this risk assessment model in predicting 1- and 2-yr post-RP EF recovery.
DESIGN, SETTING, AND PARTICIPANTS


We randomly assigned 297 patients with a preoperative International Index of Erectile Function 5 score of 22-25 undergoing robot-assisted RP by a single surgeon to a training set and internal validation set at a ratio of 2:1. A prospective external validation set included 91 patients treated by five high-volume surgeons.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Potency was defined as erections sufficient for intercourse. To predict 1- and 2-yr potency recovery, logistic regression models were developed in the training set based on 90-d erection fullness of 0-24% or 25-100%. The resultant models were applied to the internal and external validation sets to calculate risk scores for 1- and 2-yr potency for each patient. Predictive validity was assessed using receiver operating characteristic (ROC) curves.
RESULTS AND LIMITATIONS


Percentage erection fullness was an independent predictor of 1- and 2-yr potency recovery in all data sets. Internal validation confirmed strong reliability in predicting 2-yr potency outcomes (area under the ROC curve [AUC] 0.87) and external validation illustrated similar reliability in predicting 1-yr potency outcomes (AUC 0.80). In the external validation, the model predicted a mean 1-yr potency recovery rate of 39.7% (standard deviation 3.2%), compared to the actual rate of 36.26%. Limitations include the short follow-up for this cohort.
CONCLUSIONS


We present internal and external validation of a 90-d percentage erection fullness score, confirming that this metric is a robust predictor of post-RP EF recovery.
PATIENT SUMMARY


Percentage erection fullness at 3 mo after radical prostatectomy discriminates patients with a low or a high probability of recovery of erectile function (EF), which can facilitate identification of a need for early EF rehabilitation.",2020,"RESULTS AND LIMITATIONS


Percentage erection fullness was an independent predictor of 1- and 2-yr potency recovery in all data sets.","['We randomly assigned 297 patients with a preoperative International Index of Erectile Function 5 score of 22-25 undergoing robot-assisted RP by a single surgeon to a training set and internal validation set at a ratio of 2:1', 'men with normal baseline erectile function (EF) using 90-d postoperative erection fullness to identify men who might benefit from early EF rehabilitation', '91 patients treated by five high-volume surgeons']","['radical prostatectomy (RP) prediction model', 'Robot-assisted Radical Prostatectomy']","['Predictive validity', 'mean 1-yr potency recovery rate', 'Percentage erection fullness']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}]",297.0,0.0434325,"RESULTS AND LIMITATIONS


Percentage erection fullness was an independent predictor of 1- and 2-yr potency recovery in all data sets.","[{'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Huynh', 'Affiliation': 'Department of Urology, University of California Irvine, Orange, CA, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Skarecky', 'Affiliation': 'Department of Urology, University of California Irvine, Orange, CA, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Wilson', 'Affiliation': 'Department of Urology, City of Hope National Medical Center, Duarte, CA, USA.'}, {'ForeName': 'Clayon', 'Initials': 'C', 'LastName': 'Lau', 'Affiliation': 'Department of Urology, City of Hope National Medical Center, Duarte, CA, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Wagner', 'Affiliation': 'Urology Department, St. Antonius-Hospital Gronau GmbH, Gronau, Germany.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Porter', 'Affiliation': 'Swedish Urology Group, Swedish Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Jorn H', 'Initials': 'JH', 'LastName': 'Witt', 'Affiliation': 'Urology Department, St. Antonius-Hospital Gronau GmbH, Gronau, Germany.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Ahlering', 'Affiliation': 'Department of Urology, University of California Irvine, Orange, CA, USA. Electronic address: tahlerin@uci.edu.'}]",European urology oncology,['10.1016/j.euo.2018.08.030']
785,31425577,"Testosterone for Androgen Deficiency-Like Symptoms in Men Without Pathologic Hypogonadism: A Randomized, Placebo-Controlled Cross-over With Masked Choice Extension Clinical Trial.","BACKGROUND


Off-label testosterone prescribing for androgen deficiency (AD)-like sexual and energy symptoms of older men without pathologic hypogonadism has increased dramatically without convincing evidence of efficacy.
METHODS


In a randomized, double-blind, placebo-controlled study with three phases, we entered 45 men aged at least 40 years without pathologic hypogonadism but with AD-like energy and/or sexual symptoms to either daily testosterone or placebo gel treatment for 6 weeks in a cross-over study design with a third, mandatory extension phase in which participants chose which previous treatment they preferred to repeat while remaining masked to their original treatment. Primary endpoints were energy and sexual symptoms as assessed by a visual analog scale (Lead Symptom Score [LSS]).
RESULTS


Increasing serum testosterone to the healthy young male range produced no significant benefit more than placebo for energy or sexual LSS. Covariate effects of age, body mass index, and pretreatment baseline serum testosterone on quality-of-life scales were detected. Only 1 out of 22 indices from seven quality-of-life scales was significantly improved by testosterone treatment over placebo. Participants did not choose testosterone significantly more than placebo as their preferred treatment in the third phase.
CONCLUSIONS


Six-week testosterone treatment does not improve energy or sexual symptoms more than placebo in symptomatic men without pathologic hypogonadism.",2020,"RESULTS


Increasing serum testosterone to the healthy young male range produced no significant benefit more than placebo for energy or sexual LSS.","['older men without pathologic hypogonadism', 'symptomatic men without pathologic hypogonadism', 'Men Without Pathologic Hypogonadism', '45 men aged at least 40 years without pathologic hypogonadism but with AD-like energy and/or sexual symptoms to either daily', 'treatment for 6 weeks in a cross-over study design with a third, mandatory extension phase in which participants chose which previous treatment they preferred to repeat while remaining masked to their original treatment']","['testosterone or placebo gel', 'Placebo', 'Testosterone', 'placebo']","['energy and sexual symptoms as assessed by a visual analog scale (Lead Symptom Score (LSS', 'energy or sexual symptoms', 'quality of life scales']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0020619', 'cui_str': 'Hypogonadism'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0425722', 'cui_str': 'Sexual symptom (finding)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0425722', 'cui_str': 'Sexual symptom (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}]",45.0,0.671427,"RESULTS


Increasing serum testosterone to the healthy young male range produced no significant benefit more than placebo for energy or sexual LSS.","[{'ForeName': 'Shao Feng', 'Initials': 'SF', 'LastName': 'Mok', 'Affiliation': 'Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Fennell', 'Affiliation': 'Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Savkovic', 'Affiliation': 'Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Turner', 'Affiliation': 'Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Jayadev', 'Affiliation': 'Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Conway', 'Affiliation': 'Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Handelsman', 'Affiliation': 'Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz195']
786,32140973,"Sense of coherence and its relationship to participation, cancer-related fatigue, symptom burden, and quality of life in women with breast cancer participating in the OptiTrain exercise trial.","PURPOSE


This study examined the Sense of Coherence (SOC) of patients participating in the randomized controlled 'Optimal Training for Women with Breast Cancer' (OptiTrain) study and assessed how patient characteristics were associated with SOC. Secondary aims were to assess the association between SOC and patients' participation in this study and to determine whether SOC moderates the effect of the 16-week exercise intervention on fatigue, quality of life (QoL), and symptom burden in women with breast cancer undergoing chemotherapy.
METHODS


Modified Poisson regression analyses were conducted to determine the relative risk of weak-normal SOC versus strong SOC in terms of exercise session attendance, study and intervention dropout, and long absence rates. Analyses of covariance were performed to assess whether SOC moderated the effect of the exercise intervention (p interaction  ≤ 0.10).
RESULTS


Two hundred and forty women with early breast cancer (mean age 53 ± 10) participated in the OptiTrain study. Women with strong SOC reported less fatigue, lower symptom burden, and higher QoL. Women with weak-normal SOC were significantly more likely to drop out from the OptiTrain study and tended to have slightly poorer exercise session attendance. Women with breast cancer and weaker SOC benefitted as much from the exercise intervention, in terms of fatigue and QoL, as those with stronger SOC (p interaction  > 0.10).
CONCLUSIONS


Strong SOC appears to be associated with a more positive subjective state of health. Women with weak-normal SOC may need additional support to encourage participation and adherence in exercise trials. Assessing SOC may assist clinicians to identify and provide extra support for participants with weak SOC, who may be less inclined to participate in exercise programs.",2020,"Women with breast cancer and weaker SOC benefitted as much from the exercise intervention, in terms of fatigue and QoL, as those with stronger SOC (p interaction  > 0.10).
","['women with breast cancer undergoing chemotherapy', 'Women with weak-normal SOC', 'Women with breast cancer and weaker SOC', 'women with breast cancer participating in the OptiTrain exercise trial', 'Two hundred and forty women with early breast cancer (mean age 53\u2009±\u200910) participated in the OptiTrain study', ""patients participating in the randomized controlled 'Optimal Training for Women with Breast Cancer' (OptiTrain"", 'participants with weak SOC']",['exercise intervention'],"['participation, cancer-related fatigue, symptom burden, and quality of life', 'fatigue, quality of life (QoL), and symptom burden']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",240.0,0.059464,"Women with breast cancer and weaker SOC benefitted as much from the exercise intervention, in terms of fatigue and QoL, as those with stronger SOC (p interaction  > 0.10).
","[{'ForeName': 'Anouk E', 'Initials': 'AE', 'LastName': 'Hiensch', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. a.e.hiensch-2@umcutrecht.nl.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Bolam', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mijwel', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'May', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Wengström', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05378-0']
787,31806719,Targeting treatable traits in severe asthma: a randomised controlled trial.,"RATIONALE


Treatable traits have been proposed as a new paradigm for airway disease management.
OBJECTIVES


To characterise treatable traits in a severe asthma population and to determine the efficacy of targeting treatments to these treatable traits in severe asthma.
METHODS


Participants (n=140) with severe asthma were recruited to a cross-sectional study and underwent a multidimensional assessment to characterise treatable traits. Eligible participants with severe asthma (n=55) participated in a 16-week parallel-group randomised controlled trial to determine the feasibility and efficacy of management targeted to predefined treatable traits, compared to usual care in a severe asthma clinic. The patient-reported outcome of health-related quality of life was the trial's primary end-point.
MAIN RESULTS


Participants with severe asthma had a mean±sd of 10.44±3.03 traits per person, comprising 3.01±1.54 pulmonary and 4.85±1.86 extrapulmonary traits and 2.58±1.31 behavioural/risk factors. Individualised treatment that targeted the traits was feasible and led to significantly improved health-related quality of life (0.86 units, p<0.001) and asthma control (0.73, p=0.01).
CONCLUSIONS


Multidimensional assessment enables detection of treatable traits and identifies a significant trait burden in severe asthma. Targeting these treatable traits using a personalised-medicine approach in severe asthma leads to improvements in health-related quality of life, asthma control and reduced primary care acute visits. Treatable traits may be an effective way to address the complexity of severe asthma.",2020,"Targeting these treatable traits using a personalised-medicine approach in severe asthma leads to improvements in health-related quality of life, asthma control and reduced primary care acute visits.","['Participants (n=140) with severe asthma were recruited to a cross-sectional study and underwent a multidimensional assessment to characterise treatable traits', 'Eligible participants with severe asthma (n=55', 'severe asthma', 'Participants with severe asthma']",[],['health-related quality of life'],"[{'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",140.0,0.144392,"Targeting these treatable traits using a personalised-medicine approach in severe asthma leads to improvements in health-related quality of life, asthma control and reduced primary care acute visits.","[{'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'McDonald', 'Affiliation': 'National Health and Medical Research Council, Centre of Excellence in Severe Asthma, Newcastle, Australia Vanessa.McDonald@newcastle.edu.au.'}, {'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Clark', 'Affiliation': 'National Health and Medical Research Council, Centre of Excellence in Severe Asthma, Newcastle, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cordova-Rivera', 'Affiliation': 'National Health and Medical Research Council, Centre of Excellence in Severe Asthma, Newcastle, Australia.'}, {'ForeName': 'Peter A B', 'Initials': 'PAB', 'LastName': 'Wark', 'Affiliation': 'National Health and Medical Research Council, Centre of Excellence in Severe Asthma, Newcastle, Australia.'}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Baines', 'Affiliation': 'National Health and Medical Research Council, Centre of Excellence in Severe Asthma, Newcastle, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Gibson', 'Affiliation': 'National Health and Medical Research Council, Centre of Excellence in Severe Asthma, Newcastle, Australia.'}]",The European respiratory journal,['10.1183/13993003.01509-2019']
788,32512380,Continuous Wound Infiltration With Ropivacaine After Mastectomy: A Randomized Controlled Trial.,"BACKGROUND


To evaluate the efficacy of continuous wound infiltration with ropivacaine to reduce acute postoperative pain in patients undergoing mastectomy for carcinoma of the breast.
MATERIALS AND METHODS


A randomized, double-blind, placebo-controlled trial was conducted. One hundred fifty patients were randomly assigned to receive continuous ropivacaine (0.2%) (group A, n = 74) or saline solution (0.9%) (group B, n = 76) at 10 mL/h for 48 h through a multilumen catheter placed during the surgical procedure. Postoperative morphine consumption and visual analog scale (VAS) pain scores were recorded. A quality of life score (Quality of life questionnaire Core 30) and a VAS score were obtained at 1, 3, and 6 mo after surgery.
RESULTS


The difference in mean morphine consumption between the two groups was close to significance during the first 48 h postsurgery (P = 0.056; 10.8 ± 16.5 versus 4.8 ± 10.4 mg). At day 1, patients in the ropivacaine-infusion group had lower morphine consumption than the control group (P = 0.0026). The link between local ropivacaine infiltration and a decrease in mean postoperative VAS scores reached significance for the first 24 h postsurgery (P = 0.039). No significant difference was found between the two arms for VAS pain scores (P = 0.36) or for quality of life (overall QLQ-C30 score, P = 0.09) at 1, 3, or 6 mo.
CONCLUSIONS


Continuous wound infiltration with ropivacaine is efficacious in reducing postoperative pain. Quality of life and chronic pain at 1, 3, and 6 mo were not improved by ropivacaine wound infiltration.",2020,"No significant difference was found between the two arms for VAS pain scores (P = 0.36) or for quality of life (overall QLQ-C30 score, P = 0.09) at 1, 3, or 6 mo.
","['patients undergoing mastectomy for carcinoma of the breast', 'One hundred fifty patients']","['ropivacaine-infusion', 'ropivacaine', 'Mastectomy', 'saline solution', 'continuous ropivacaine', 'Ropivacaine', 'placebo']","['Quality of life and chronic pain', 'acute postoperative pain', 'A quality of life score (Quality of life questionnaire Core 30) and a VAS score', 'postoperative pain', 'mean morphine consumption', 'mean postoperative VAS scores', 'morphine consumption', 'quality of life (overall QLQ-C30 score', 'VAS pain scores', 'Postoperative morphine consumption and visual analog scale (VAS) pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0238033', 'cui_str': 'Carcinoma of male breast'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",150.0,0.396965,"No significant difference was found between the two arms for VAS pain scores (P = 0.36) or for quality of life (overall QLQ-C30 score, P = 0.09) at 1, 3, or 6 mo.
","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Beguinot', 'Affiliation': ""Département d'oncologie, Médipôle Hôpital Mutualiste Lyon Villeurbanne, Villeurbanne, France.""}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Monrigal', 'Affiliation': 'Département de Chirurgie Sénologique, Montpellier Institut du Sein, Clinique Clémentville, Montpellier, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Kwiatkowski', 'Affiliation': 'Délégation Recherche Clinique & Innovation, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.'}, {'ForeName': 'Angeline', 'Initials': 'A', 'LastName': 'Ginzac', 'Affiliation': ""Délégation Recherche Clinique & Innovation, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France; Université Clermont Auvergne, Centre Jean Perrin, INSERM, U1240 Imagerie Moléculaire et Stratégies Théranostiques, Clermont-Ferrand, France; Centre d'Investigation Clinique, UMR501, Clermont-Ferrand, France. Electronic address: Angeline.ginzac@clermont.unicancer.fr.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Joly', 'Affiliation': ""Département d'anesthésie-réanimation, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Gayraud', 'Affiliation': ""Département d'anesthésie-réanimation, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Le Bouedec', 'Affiliation': 'Département de Chirurgie Oncologique, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gimbergues', 'Affiliation': 'Département de Chirurgie Oncologique, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.006']
789,31789348,Ergocalciferol improves endothelial vasodilatory and vasoconstrictor function in an in vivo model of mild uraemia.,"Endothelial dysfunction and vitamin D deficiency are prevalent in patients with cardiovascular disease (CVD) and chronic kidney disease (CKD). Both are risk factors for cardiovascular events in patients with CKD. No studies have investigated the effect of nutritional forms of vitamin D on endothelial function in earlier stages of CKD, when vascular endothelium may be more amenable to this therapy. We studied the effect of ergocalciferol in a pre-clinical model of mild uraemia. Male Wistar rats underwent either a 5/6th nephrectomy or sham surgery. Four weeks after the final stage of the surgery, these two groups were randomly allocated to placebo or an oral dose of 1000 iu of ergocalcfierol at day 7 and 2 pre sacrifice. Vascular responses to acetylcholine, Spermine NONOate and phenylephrine were determined in aortic rings. Blood pressure, calcium, phosphate and parathyroid hormone were measured in all groups. Ergocalciferol significantly improved the endothelium-dependent responses to acetylcholine and overcame the blunting of the contractile response to phenylephrine seen in uraemic animals. Ergocalciferol improved the contractile response to potassium chloride in uraemic, but not sham animals. All effects occurred independently of changes to calcium, phosphate, parathyroid hormone and systolic blood pressure. There were no differences in endothelium-independent relaxation to Spermine NONOate. In summary, in a model of mild uraemia, ergocalciferol improved vasodilator and vasoconstrictor tone independently of blood pressure and bone mineral parameters suggesting a direct effect of ergocalciferol on the endothelium.",2019,Ergocalciferol significantly improved the endothelium-dependent responses to acetylcholine and overcame the blunting of the contractile response to phenylephrine seen in uraemic animals.  ,"['patients with cardiovascular disease (CVD) and chronic kidney disease (CKD', 'Male Wistar rats', 'patients with CKD']","['acetylcholine, Spermine NONOate and phenylephrine', 'nephrectomy or sham surgery', 'placebo', 'Ergocalciferol', 'ergocalciferol', 'vitamin D']","['Blood pressure, calcium, phosphate and parathyroid hormone', 'contractile response', 'calcium, phosphate, parathyroid hormone and systolic blood pressure', 'blood pressure and bone mineral parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0034716', 'cui_str': 'Rats, Wistar'}]","[{'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0293944', 'cui_str': 'spermine NONOate'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0027695', 'cui_str': 'Nephrectomy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0014696', 'cui_str': 'Calciferols'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.122966,Ergocalciferol significantly improved the endothelium-dependent responses to acetylcholine and overcame the blunting of the contractile response to phenylephrine seen in uraemic animals.  ,"[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Dreyer', 'Affiliation': 'William Harvey Research Institute of Queen Mary University, John Vane Science Building, Charterhouse Square Campus, London EC1B 6BQ, U.K.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Kieswich', 'Affiliation': 'William Harvey Research Institute of Queen Mary University, John Vane Science Building, Charterhouse Square Campus, London EC1B 6BQ, U.K.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Harwood', 'Affiliation': 'William Harvey Research Institute of Queen Mary University, John Vane Science Building, Charterhouse Square Campus, London EC1B 6BQ, U.K.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Ahluwalia', 'Affiliation': 'Department of Vascular Pharmacology, William Harvey Research Institute of Queen Mary University, John Vane Science Building, Charterhouse Square Campus, London EC1B 6BQ, U.K.'}, {'ForeName': 'Muhammad M', 'Initials': 'MM', 'LastName': 'Yaqoob', 'Affiliation': 'William Harvey Research Institute of Queen Mary University, John Vane Science Building, Charterhouse Square Campus, London EC1B 6BQ, U.K.'}]",Bioscience reports,['10.1042/BSR20190711']
790,32499552,"Subjective versus objective, polymer bur-based selective carious tissue removal: 1-year interim analysis of a randomized clinical trial.","We aimed to compare subjective (S) vs. objective (O) selective carious tissue removal using hand-excavation versus a self-limiting polymer bur, respectively. A community-based single-blind cluster-randomized controlled superiority trial was performed. This is a 1-year-interim analysis. 115 children (age 7-8 years) with ≥1 vital primary molar with a deep dentin lesion (>1/2 dentin depth) were included (60 S/55 O). The cluster was the child, with eligible molars being treated identically (91 S/86 O). Cavities were prepared and carious tissue on pulpo-proximal walls selectively removed using hand instruments (S), or a self-limiting polymer bur (Polybur P1, Komet). Cavities were restored using glass-hybrid material (Equia Forte, GC). Treatment times and children's satisfaction were recorded. Generalized-linear models (GLM) and multi-level Cox-regression analysis were applied. Initial treatment times were not significantly different between protocols (mean; 95%CI S: 433; 404-462 sec; O: 412; 382-441 sec; p = 0.378/GLM). There was no significant difference in patients' satisfaction (p = 0.164). No pulpal exposures occurred. 113 children were re-examined. Failures occurred in 22/84 O-molars (26.2%) and 26/90 S-molars (28.9%). Pulpal complications occurred in 5(6%) O and 2(2.2%) S molars, respectively. Risk of failure was not significantly associated with the removal protocol, age, sex, dental arch or tooth type (p > 0.05/Cox), but was nearly 5-times higher in multi-surface than single-surface restorations (HR: 4.60; 95% CI: 1.70-12.4). Within the limitations of this interim analysis, there was no significant difference in treatment time, satisfaction and risk of failure between O and S.",2020,113 children were re-examined. Failures occurred in 22/84 O-molars (26.2%) and 26/90 S-molars (28.9%).,"['113 children', '115 children (age 7-8 years) with ≥1 vital primary molar with a deep dentin lesion (>1/2 dentin depth) were included (60\u2009S/55\u2009O']",['polymer bur-based selective carious tissue removal'],"[""Treatment times and children's satisfaction"", ""patients' satisfaction"", 'Risk of failure', 'Pulpal complications', 'treatment time, satisfaction and risk of failure between O and S']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",115.0,0.0819157,113 children were re-examined. Failures occurred in 22/84 O-molars (26.2%) and 26/90 S-molars (28.9%).,"[{'ForeName': 'Marta Gomes', 'Initials': 'MG', 'LastName': 'Marques', 'Affiliation': 'Graduate Program in Dentistry, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Leandro Augusto', 'Initials': 'LA', 'LastName': 'Hilgert', 'Affiliation': 'Department of Dentistry, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Larissa Ribeiro', 'Initials': 'LR', 'LastName': 'Silva', 'Affiliation': 'Graduate Program in Dentistry, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Karine Medeiros', 'Initials': 'KM', 'LastName': 'Demarchi', 'Affiliation': 'Graduate Program in Health Sciences, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Patrícia Magno', 'Initials': 'PM', 'LastName': 'Dos Santos Matias', 'Affiliation': 'Graduate Program in Dentistry, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Ana Paula Dias', 'Initials': 'APD', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Restorative Dental Sciences, University of Florida College of Dentistry, Gainesville, Florida, USA.'}, {'ForeName': 'Soraya Coelho', 'Initials': 'SC', 'LastName': 'Leal', 'Affiliation': 'Department of Dentistry, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Paris', 'Affiliation': 'Department of Oral Diagnostics, Digital Health, Health Services Research, Charité- Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Schwendicke', 'Affiliation': 'Department of Oral Diagnostics, Digital Health, Health Services Research, Charité- Universitätsmedizin, Berlin, Germany. falk.schwendicke@charite.de.'}]",Scientific reports,['10.1038/s41598-020-66074-x']
791,32507538,Vitamin D Supplementation Improves Health-Related Quality of Life and Physical Performance in Children with Sickle Cell Disease and in Healthy Children.,"INTRODUCTION


No study determined if vitamin D supplementation improves health-related quality of life (HRQL) using pediatric Patient-Reported Outcomes Measurement Information System or physical functioning in type SS sickle cell disease (HbSS).
METHOD


Subjects with HbSS (n = 21) and healthy subjects (n = 23) were randomized to daily oral doses (4,000 vs. 7,000 IU) of cholecalciferol (vitamin D 3 ) and evaluated at 6 and 12 weeks for changes in serum 25 hydroxyvitamin D (25(OH)D), HRQL, and physical functioning.
RESULTS


In subjects with HbSS, significant reductions in pain, fatigue, and depressive symptoms and improved upper-extremity function were observed. In healthy subjects, significant reductions in fatigue and improved upper-extremity function were observed. Significant improvements in peak power and dorsiflexion isometric maximal voluntary contraction torques were observed in both groups. In subjects with HbSS, improved plantar flexion isometric maximal voluntary contraction torques were observed. Both groups saw significant improvement in their total Bruininks-Oseretsky Test of Motor Proficiency score.
DISCUSSION


Daily high-dose vitamin D supplementation for African American children with and without HbSS improved HRQL and physical performance.",2020,Significant improvements in peak power and dorsiflexion isometric maximal voluntary contraction torques were observed in both groups.,"['African American children', 'type SS sickle cell disease (HbSS', 'Subjects with HbSS (n\u202f=\u202f21) and healthy subjects (n\u202f=\u202f23', 'Children with Sickle Cell Disease and in Healthy Children']","['Vitamin D Supplementation', 'cholecalciferol (vitamin D 3 ) and evaluated at 6 and 12 weeks for changes in serum 25 hydroxyvitamin D (25(OH)D), HRQL, and physical functioning', 'vitamin D supplementation']","['Health-Related Quality of Life and Physical Performance', 'health-related quality of life (HRQL', 'pain, fatigue, and depressive symptoms and improved upper-extremity function', 'HRQL and physical performance', 'total Bruininks-Oseretsky Test of Motor Proficiency score', 'peak power and dorsiflexion isometric maximal voluntary contraction torques', 'fatigue and improved upper-extremity function', 'plantar flexion isometric maximal voluntary contraction torques']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686744', 'cui_str': 'Well child'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion'}]",23.0,0.0773497,Significant improvements in peak power and dorsiflexion isometric maximal voluntary contraction torques were observed in both groups.,"[{'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Dougherty', 'Affiliation': ''}, {'ForeName': 'Joan I', 'Initials': 'JI', 'LastName': 'Schall', 'Affiliation': ''}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Bertolaso', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Smith-Whitley', 'Affiliation': ''}, {'ForeName': 'Virginia A', 'Initials': 'VA', 'LastName': 'Stallings', 'Affiliation': ''}]",Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners,['10.1016/j.pedhc.2020.04.007']
792,32510696,"Biomarkers of oxidative stress and inflammation in people witha physical disability treated with a standardized extract of Nasturtium officinale: A randomized, double-blind, and placebo-controlled trial.","It is well established that plants from the Brassicaceae family, particularly watercress, have been associated to reduce oxidative DNA damage. Nasturtium officinale R. Br (watercress) contains glucosinolates, with anti-inflammatory action and protective effect on human health against oxidative stress. We aimed to evaluate whether the standardized extract of Nasturtium officinale (SENO) is capable of changing biomarkers of oxidative stress and inflammation in people with physical disabilities. 65 people enrolled this study: as a control group composed by; 15 people with no physical disability assessed once, 25 people with physical disabilities using 750 mg/kg/day of SENO, and 25 people with physical disabilities using 750 mg/kg/day of placebo-control for 5 weeks. Biomarkers of oxidative stress and inflammation were analyzed on day 0 and 36. The results indicated that SENO was associated with decreasing levels of lipid peroxidation, protein carbonyl, catalase, superoxide dismutase, and C-reactive protein. Furthermore, the cytokine kit demonstrated below and out of invertible range, which was impossible to detect the inflammatory process. Despite the cytokine kit was not able to detect the inflammation; these data might provide supportive evidence that SENO, have affected positively people with physical disabilities decreasing their biomarkers of oxidative stress and C-reactive protein. Further studies are required.",2020,"The results indicated that SENO was associated with decreasing levels of lipid peroxidation, protein carbonyl, catalase, superoxide dismutase, and C-reactive protein.","['people witha physical disability treated with a standardized extract of Nasturtium officinale', 'people with physical disabilities', '65 people enrolled this study: as a control group composed by; 15 people with no physical disability assessed once, 25 people with physical disabilities using 750\u2009mg/kg/day of SENO, and 25 people with physical disabilities using 750\u2009mg/kg/day of']","['SENO', 'standardized extract of Nasturtium officinale (SENO', 'placebo-control for 5\u2009weeks', 'placebo']","['levels of lipid peroxidation, protein carbonyl, catalase, superoxide dismutase, and C-reactive protein']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0453151', 'cui_str': 'Watercress'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0453151', 'cui_str': 'Watercress'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",65.0,0.179116,"The results indicated that SENO was associated with decreasing levels of lipid peroxidation, protein carbonyl, catalase, superoxide dismutase, and C-reactive protein.","[{'ForeName': 'Mirna', 'Initials': 'M', 'LastName': 'Clemente', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Marilis D', 'Initials': 'MD', 'LastName': 'Miguel', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Karina B', 'Initials': 'KB', 'LastName': 'Felipe', 'Affiliation': 'Department of Biochemistry, Federal University of Parana, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gribner', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'F Moura', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Ana Angelica', 'Initials': 'AA', 'LastName': 'R Rigoni', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'B Parisotto', 'Affiliation': 'School of Pharmaceutical Sciences, Food and Nutrition, Federal University of Mato Grosso do Sul, Brazil.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'T Piltz', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Glaucio', 'Initials': 'G', 'LastName': 'Valdameri', 'Affiliation': 'Clinical Analysis Department, Federal University of Parana, Brazil.'}, {'ForeName': 'Railson', 'Initials': 'R', 'LastName': 'Henneberg', 'Affiliation': 'Clinical Analysis Department, Federal University of Parana, Brazil.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'B Schonhofen', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'João Luiz', 'Initials': 'JL', 'LastName': 'S Carvalho', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Luiz Claudio', 'Initials': 'LC', 'LastName': 'Fernandes', 'Affiliation': 'Department of Physiology, Federal University of Parana, Brazil.'}, {'ForeName': 'Obdúlio', 'Initials': 'O', 'LastName': 'G Miguel', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}]",Phytotherapy research : PTR,['10.1002/ptr.6718']
793,32513518,Combinatorial Pharmacogenomic Testing Improves Outcomes for Older Adults With Depression.,"OBJECTIVE


Evaluate the clinical utility of combinatorial pharmacogenomic testing for informing medication selection among older adults who have experienced antidepressant medication failure for major depressive disorder (MDD).
DESIGN


Post hoc analysis of data from a blinded, randomized controlled trial comparing two active treatment arms.
SETTING


Psychiatry specialty and primary care clinics across 60 U.S. community and academic sites.
PARTICIPANTS


Adults age 65 years or older at baseline (n = 206), diagnosed with MDD and inadequate response to at least one medication on the combinatorial pharmacogenomic test report during the current depressive episode.
INTERVENTION


Combinatorial pharmacogenomic testing to inform medication selection (guided-care), compared with treatment as usual (TAU).
OUTCOMES


Mean percent symptom improvement, response rate, and remission rateat week 8, measured using the 17-item Hamilton Depression Rating Scale; medication switching; and comorbidity moderator analysis.
RESULTS


At week 8, symptom improvement was not significantly different for guided-care than for TAU (∆ = 8.1%, t = 1.64, df = 187; p = 0.102); however, guided-care showed significantly improved response (∆ = 13.6%, t = 2.16, df = 187; p = 0.032) and remission (∆ = 12.7%, t = 2.49, df = 189; p = 0.014) relative to TAU. By week 8, more than twice as many patients in guided-care than in TAU were on medications predicted to have no gene-drug interactions (χ 2  = 19.3, df = 2; p <0.001). Outcomes in the guided-care arm showed consistent improvement through the end of the open-design 24-week trial, indicating durability of the effect. Differences in outcomes between arms were not significantly impacted by comorbidities.
CONCLUSIONS


Combinatorial pharmacogenomic test-informed medication selection improved outcomes over TAU among older adults with depression.",2020,"At week 8, symptom improvement was not significantly different for guided-care than for TAU (∆ = 8.1%, t = 1.64, df = 187; p = 0.102); however, guided-care showed significantly improved response (∆ = 13.6%, t = 2.16, df = 187; p = 0.032) and remission (∆ = 12.7%, t = 2.49, df = 189; p = 0.014) relative to TAU.","['older adults with depression', 'older adults who have experienced antidepressant medication failure for major depressive disorder (MDD', 'Psychiatry specialty and primary care clinics across 60 U.S. community and academic sites', 'Older Adults With Depression', 'Adults age 65 years or older at baseline (n\u202f=\u202f206), diagnosed with MDD and inadequate response to at least one medication on the combinatorial pharmacogenomic test report during the current depressive episode']","['combinatorial pharmacogenomic testing', 'Combinatorial PharmacogenomicTesting']","['Mean percent symptom improvement, response rate, and remission rateat', 'symptom improvement', '17-item Hamilton Depression Rating Scale; medication switching; and comorbidity moderator analysis', 'remission']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C2347501', 'cui_str': 'Pharmacogenomic Screening'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}]","[{'cui': 'C2347501', 'cui_str': 'Pharmacogenomic Screening'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",,0.0861888,"At week 8, symptom improvement was not significantly different for guided-care than for TAU (∆ = 8.1%, t = 1.64, df = 187; p = 0.102); however, guided-care showed significantly improved response (∆ = 13.6%, t = 2.16, df = 187; p = 0.032) and remission (∆ = 12.7%, t = 2.49, df = 189; p = 0.014) relative to TAU.","[{'ForeName': 'Brent P', 'Initials': 'BP', 'LastName': 'Forester', 'Affiliation': 'Division of Geriatric Psychiatry (BPF, IV), McLean Hospital, Harvard Medical School, Belmont, MA. Electronic address: bforester@mclean.harvard.edu.'}, {'ForeName': 'Sagar V', 'Initials': 'SV', 'LastName': 'Parikh', 'Affiliation': 'University of Michigan Comprehensive Depression Center and Department of Psychiatry (SVP, JFG), National Network of Depression Centers, Ann Arbor, MI.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Weisenbach', 'Affiliation': 'Stony Brook University, Department of Psychiatry & Behavioral Health (SW), Stony Brook, NY.'}, {'ForeName': 'Olusola', 'Initials': 'O', 'LastName': 'Ajilore', 'Affiliation': 'University of Illinois at Chicago, School of Public Health/Psychiatric Institute (OJ), Chicago, IL.'}, {'ForeName': 'Ipsit', 'Initials': 'I', 'LastName': 'Vahia', 'Affiliation': 'Division of Geriatric Psychiatry (BPF, IV), McLean Hospital, Harvard Medical School, Belmont, MA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Rothschild', 'Affiliation': 'University of Massachusetts Medical School and UMass Memorial Healthcare (AJR), Worcester, MA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, the Corporal Michael Crescenz VAMC (MET), Philadelphia, PA.'}, {'ForeName': 'Boadie W', 'Initials': 'BW', 'LastName': 'Dunlop', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences (BWD), Atlanta, GA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'DeBattista', 'Affiliation': 'Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences (CDB), Stanford, CA.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Conway', 'Affiliation': ""Washington University School of Medicine, Department of Psychiatry, and the John Cochran Veteran's Administration Hospital (CRC), St. Louis, MO.""}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'The University of Alabama at Birmingham, Department of Psychiatry and School of Medicine (RCS), Birmingham, AL.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Macaluso', 'Affiliation': 'University of Kansas School of Medicine-Wichita, Department of Psychiatry and Behavioral Sciences (MM), Wichita, KS.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Assurex Health, Inc./Myriad Neuroscience (PT, LB), Mason, OH.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Traxler', 'Affiliation': 'Assurex Health, Inc./Myriad Neuroscience (PT, LB), Mason, OH.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Logan', 'Affiliation': 'Myriad Genetics, Inc. (JL, BD), Salt Lake City, UT.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Assurex Health, Inc./Myriad Neuroscience (PT, LB), Mason, OH.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Dechairo', 'Affiliation': 'Myriad Genetics, Inc. (JL, BD), Salt Lake City, UT.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Greden', 'Affiliation': 'University of Michigan Comprehensive Depression Center and Department of Psychiatry (SVP, JFG), National Network of Depression Centers, Ann Arbor, MI.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.05.005']
794,32516094,Comparison of individual and group-based load-velocity profiling as a means to dictate training load over a 6-week strength and power intervention.,"This study compared the effects of dictating load using individual (ILVP) or group (GLVP) load-velocity profiles on lower-body strength and power. Nineteen trained males (23.6 ± 3.7 years) completed a back squat one-repetition maximum (1-RM), load-velocity profiling (LVP), and countermovement (CMJ), static-squat (SSJ) and standing-broad (SBJ) jump tests before and after 6 weeks of resistance training. Participants were randomly assigned to an ILVP, or GLVP intervention with intra-session load dictated through real-time velocity monitoring and prediction of current relative performance using either the participant's LVP (ILVP) or a LVP based on all participant data (GLVP). Training resulted in significant increases in back squat 1-RM for the ILVP and GLVP group ( p  < 0.01; 9.7% and 7.2%, respectively), with no group-by-time interaction identified between training groups ( p  = 0.06). All jump performance significantly increased for the ILVP group ( p  < 0.01; CMJ: 6.6%; SSJ: 4.6%; SBJ: 6.7%), with only CMJ and SSJ improving for the GLVP group ( p  < 0.05; 4.3%). Despite no significant group-by-time interaction across all variables, the ILVP intervention induced a greater magnitude of adaptation when compared to a GLVP approach. Additionally, an individualised approach may lead to greater positive transfer to power-based movements, specifically vertical and horizontal jumps.",2020,"All jump performance significantly increased for the ILVP group ( p  < 0.01; CMJ: 6.6%; SSJ: 4.6%; SBJ: 6.7%), with only CMJ and SSJ improving for the GLVP group ( p  < 0.05; 4.3%).",['Nineteen trained males (23.6\xa0±\xa03.7\xa0years) completed a'],"['dictating load using individual (ILVP) or group (GLVP) load-velocity profiles', 'ILVP', ""ILVP, or GLVP intervention with intra-session load dictated through real-time velocity monitoring and prediction of current relative performance using either the participant's LVP (ILVP) or a LVP based on all participant data (GLVP""]","['back squat one-repetition maximum (1-RM), load-velocity profiling (LVP), and countermovement (CMJ), static-squat (SSJ) and standing-broad (SBJ) jump tests', 'back squat 1-RM']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",19.0,0.0213899,"All jump performance significantly increased for the ILVP group ( p  < 0.01; CMJ: 6.6%; SSJ: 4.6%; SBJ: 6.7%), with only CMJ and SSJ improving for the GLVP group ( p  < 0.05; 4.3%).","[{'ForeName': 'Harry F', 'Initials': 'HF', 'LastName': 'Dorrell', 'Affiliation': 'School of Sport and Exercise Science, College of Social Sciences, University of Lincoln , Lincoln, UK.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Moore', 'Affiliation': 'School of Sport, Health and Exercise Science, Faculty of Science and Health, University of Portsmouth , Portsmouth, UK.'}, {'ForeName': 'Thomas I', 'Initials': 'TI', 'LastName': 'Gee', 'Affiliation': 'School of Sport and Exercise Science, College of Social Sciences, University of Lincoln , Lincoln, UK.'}]",Journal of sports sciences,['10.1080/02640414.2020.1767338']
795,32493344,"Linagliptin, when compared to placebo, improves CD34+ve endothelial progenitor cells in type 2 diabetes subjects with chronic kidney disease taking metformin and/or insulin: a randomized controlled trial.","BACKGROUND


Endothelial Progenitor cells (EPCs) has been shown to be dysfunctional in both type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) leading to poor regeneration of endothelium and renal perfusion. EPCs have been shown to be a robust cardiovascular disease (CVD) risk indicator. Cellular mechanisms of DPP4 inhibitors such as linagliptin (LG) on CVD risk, in patients with T2DM with established CKD has not been established. Linagliptin, a DPP4 inhibitor when added to insulin, metformin or both may improve endothelial dysfunction in a diabetic kidney disease (DKD) population.
METHODS


31 subjects taking metformin and/or Insulin were enrolled in this 12 weeks, double blind, randomized placebo matched trial, with 5 mg LG compared to placebo. Type 2 diabetes subjects (30-70 years old), HbA1c of 6.5-10%, CKD Stage 1-3 were included. CD34+ cell number, migratory function, gene expression along with vascular parameters such as arterial stiffness, biochemistry, resting energy expenditure and body composition were measured. Data were collected at week 0, 6 and 12. A mixed model regression analysis was done with p value < 0.05 considered significant.
RESULTS


A double positive CD34/CD184 cell count had a statistically significant increase (p < 0.02) as determined by flow cytometry in LG group where CD184 is SDF1a cell surface receptor. Though mRNA differences in CD34+ve was more pronounced CD34- cell mRNA analysis showed increase in antioxidants (superoxide dismutase 2 or SOD2, Catalase and Glutathione Peroxidase or GPX) and prominent endothelial markers (PECAM1, VEGF-A, vWF and NOS3). Arterial stiffness measures such as augmentation Index (AI) (p < 0.04) and pulse wave analysis (PWV) were improved (reduced in stiffness) in LG group. A reduction in LDL: HDL ratio was noted in treatment group (p < 0.04). Urinary exosome protein examining podocyte health (podocalyxin, Wilms tumor and nephrin) showed reduction or improvement.
CONCLUSIONS


In DKD subjects, Linagliptin promotes an increase in CXCR4 expression on CD34 + progenitor cells with a concomitant improvement in vascular and renal parameters at 12 weeks. Trial Registration Number NCT02467478 Date of Registration: 06/08/2015.",2020,Arterial stiffness measures such as augmentation Index (AI) (p < 0.04) and pulse wave analysis (PWV) were improved (reduced in stiffness) in LG group.,"['patients with T2DM with established CKD', 'Type 2 diabetes subjects (30-70\xa0years old), HbA1c of 6.5-10%, CKD Stage 1-3 were included', '31 subjects taking', 'type 2 diabetes subjects with chronic kidney disease taking']","['Linagliptin', 'linagliptin (LG', 'metformin', 'Endothelial Progenitor cells (EPCs', 'metformin and/or insulin', 'placebo']","['Arterial stiffness measures such as augmentation Index (AI', 'LDL: HDL ratio', 'endothelial dysfunction', 'CXCR4 expression', 'CD34+ cell number, migratory function, gene expression along with vascular parameters such as arterial stiffness, biochemistry, resting energy expenditure and body composition', 'pulse wave analysis (PWV', 'antioxidants (superoxide dismutase 2 or SOD2, Catalase and Glutathione Peroxidase or GPX) and prominent endothelial markers (PECAM1, VEGF-A, vWF and NOS3', 'CD34+ve endothelial progenitor cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C2316401', 'cui_str': 'Chronic kidney disease stage 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C2352110', 'cui_str': 'CXCR4 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0232901', 'cui_str': 'Migratory'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C3494430', 'cui_str': 'Pulse Wave Analysis'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0968147', 'cui_str': 'superoxide dismutase 2'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0669365', 'cui_str': 'NOS3 protein, human'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}]",,0.207918,Arterial stiffness measures such as augmentation Index (AI) (p < 0.04) and pulse wave analysis (PWV) were improved (reduced in stiffness) in LG group.,"[{'ForeName': 'Hassan B', 'Initials': 'HB', 'LastName': 'Awal', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA.'}, {'ForeName': 'Seshagiri Rao', 'Initials': 'SR', 'LastName': 'Nandula', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Cleyton C', 'Initials': 'CC', 'LastName': 'Domingues', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Fiona J', 'Initials': 'FJ', 'LastName': 'Dore', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Nabanita', 'Initials': 'N', 'LastName': 'Kundu', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Beda', 'Initials': 'B', 'LastName': 'Brichacek', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fakhri', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Elzarki', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Neeki', 'Initials': 'N', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Shauna', 'Initials': 'S', 'LastName': 'Safai', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Magan', 'Initials': 'M', 'LastName': 'Fosso', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Amdur', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA.'}, {'ForeName': 'Sabyasachi', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA. ssen1@gwu.edu.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01046-z']
796,31836250,Re: TVT Surgery versus Bulkamid Injection for Primary Stress Urinary Incontinence: A Randomized Clinical Trial.,,2020,,['Primary Stress Urinary Incontinence'],['Re: TVT Surgery versus Bulkamid Injection'],[],"[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2353119', 'cui_str': 'Bulkamid'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]",[],,0.1103,,"[{'ForeName': 'Dmitry Y', 'Initials': 'DY', 'LastName': 'Pushkar', 'Affiliation': 'Moscow State Medical University of Medicine and Dentistry, Moscow, Russian Federation.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Kasyan', 'Affiliation': 'Moscow State Medical University of Medicine and Dentistry, Moscow, Russian Federation. Electronic address: gkasyan@msmsu.ru.'}]",European urology,['10.1016/j.eururo.2019.11.028']
797,32493715,"Starch Digestion-Related Amylase Genetic Variants, Diet, and Changes in Adiposity: Analyses in Prospective Cohort Studies and a Randomized Dietary Intervention.","Salivary amylase, encoded by the  AMY1  gene, is responsible for the digestion of carbohydrates. We investigated associations of  AMY1  genetic variations with general and central adiposity changes considering dietary carbohydrate intake among 32,054 adults from four prospective cohort studies. A genetic risk score (GRS) was calculated based on nine  AMY1  single-nucleotide polymorphisms, with higher AMY1-GRS indicating higher activity of salivary amylase. We meta-analyzed interactions between AMY1-GRS and dietary intake for changes in general and central adiposity over 5.5-10 years. We found that carbohydrate food intake significantly altered associations of AMY1-GRS with changes in BMI ( P   interaction  = 0.001) and waist circumference ( P   interaction  < 0.001). Results were consistent and significant in female cohorts rather than in male cohorts. Among women, higher AMY1-GRS was associated with more increases in adiposity if dietary carbohydrate food intake was high, while higher AMY1-GRS was associated with less gains in adiposity when the dietary intake was low. Also, in a 2-year randomized dietary intervention trial, associations of AMY1-GRS with changes in weight ( P   interaction  = 0.023) and waist circumference ( P   interaction  = 0.037) were significantly modified by carbohydrate intake. Our results suggest the importance of precision nutrition strategies considering participants' genetic adaptation to carbohydrate-rich diets in regulating general and central adiposity.",2020,"Among women, higher AMY1-GRS was associated with more increases in adiposity if dietary carbohydrate food intake was high, while higher AMY1-GRS was associated with less gains in adiposity when the dietary intake was low.",['32054 adults from 4 prospective cohort studies'],[],"['genetic risk score (GRS', 'waist circumference', 'adiposity if dietary carbohydrate food intake', 'body mass index']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],"[{'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012170', 'cui_str': 'Carbohydrates, Dietary'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",32054.0,0.0265795,"Among women, higher AMY1-GRS was associated with more increases in adiposity if dietary carbohydrate food intake was high, while higher AMY1-GRS was associated with less gains in adiposity when the dietary intake was low.","[{'ForeName': 'Yoriko', 'Initials': 'Y', 'LastName': 'Heianza', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA nhyoh@channing.harvard.edu lqi1@tulane.edu luqi@hsph.harvard.edu.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yuhang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Walter C', 'Initials': 'WC', 'LastName': 'Willett', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Frank B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA nhyoh@channing.harvard.edu lqi1@tulane.edu luqi@hsph.harvard.edu.'}]",Diabetes,['10.2337/db19-1257']
798,32497524,"Single-shot live-attenuated chikungunya vaccine in healthy adults: a phase 1, randomised controlled trial.","BACKGROUND


Chikungunya disease, which results in incapacitating arthralgia, has been reported worldwide. We developed a live-attenuated chikungunya virus (CHIKV) vaccine candidate designed for active immunisation of the general population living in endemic regions, as well as serving as a prophylactic measure for travellers to endemic areas.
METHODS


This single-blind, randomised, dose-escalation, phase 1 study investigated as primary outcome safety of a live-attenuated CHIKV vaccine candidate. At two professional clinical trial centres in Illinois and Alabama, USA, healthy volunteers aged 18-45 years were randomly assigned (1:1:2) to one of three escalating dose groups (low dose 3·2 × 10 3  per 0·1 mL; medium dose 3·2 × 10 4  per 1 mL; or high dose 3·2 × 10 5  50% tissue culture infection dose per 1 mL) and received a single-shot immunisation on day 0. Individuals in all groups were revaccinated with the highest dose on either month 6 or 12, and followed up for 28 days after revaccination. The safety analysis included all individuals who received the single vaccination; the immunogenicity analysis, which was a secondary outcome, included all individuals who completed the study without major protocol deviations (per-protocol population). The study is registered with ClinicalTrials.gov, NCT03382964, and is complete.
FINDINGS


The study was done between March 5, 2018, and Jul 23, 2019, with 120 adults recruited and enrolled between March 5 and June 21, 2018, and assigned to receive a low (n=31), medium (n=30), or high (n=59) dose of the vaccine. The vaccine was safe in the high-dose group and well tolerated in the low-dose and medium-dose groups. Four (7%) of 59 vaccinees in the high-dose group reported any local reaction, and 11 (36%), 12 (40%), and 40 (68%) volunteers in the low-dose, medium-dose, and high-dose groups, respectively, reported any solicited systemic reaction. No vaccine-related serious adverse events were reported. Data up to month 12 after a single immunisation of the 120 healthy volunteers showed a good immunogenicity profile with 100% seroconversion rates achieved at day 14 (103 [100%] of 103) and sustained for 1 year across all dose groups. Mean peak antibody titres at day 28 ranged from 592·6 to 686·9 geometric mean titres from the low-dose to high-dose groups, respectively. A single vaccination was sufficient to induce sustaining high-titre neutralising antibodies, as shown by the absence of an anamnestic response after any revaccination ranging from 94% to 100% of participants. Following revaccination, vaccinees were protected from vaccine-induced viraemia.
INTERPRETATION


A novel live-attenuated CHIKV vaccine was well tolerated and highly immunogenic in an adult population and could be an effective intervention for prophylaxis of chikungunya disease worldwide.
FUNDING


Valneva, Vienna, Austria; Coalition for Epidemic Preparedness Innovation and EU Horizon 2020.",2020,"Mean peak antibody titres at day 28 ranged from 592·6 to 686·9 geometric mean titres from the low-dose to high-dose groups, respectively.","['120 healthy volunteers', 'individuals who received the single vaccination; the immunogenicity analysis, which was a secondary outcome, included all individuals who completed the study without major protocol deviations (per-protocol population', 'At two professional clinical trial centres in Illinois and Alabama, USA, healthy volunteers aged 18-45 years', 'healthy adults', 'March 5, 2018, and Jul 23, 2019, with 120 adults recruited and enrolled between March 5 and June 21, 2018, and assigned to receive a low (n=31), medium (n=30), or high (n=59) dose of the', '3·2\u2008×', 'active immunisation of the general population living in endemic regions']","['Single-shot live-attenuated chikungunya vaccine', 'live-attenuated CHIKV vaccine candidate', 'vaccine', 'medium dose\u20083·2', 'live-attenuated chikungunya virus (CHIKV) vaccine']","['local reaction', 'solicited systemic reaction', 'tolerated', 'seroconversion rates', 'Mean peak antibody titres', 'good immunogenicity profile']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205991', 'cui_str': 'Active immunization'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0008055', 'cui_str': 'Chikungunya fever'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0008056', 'cui_str': 'Chikungunya virus'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",120.0,0.316388,"Mean peak antibody titres at day 28 ranged from 592·6 to 686·9 geometric mean titres from the low-dose to high-dose groups, respectively.","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Wressnigg', 'Affiliation': 'Valneva, Vienna, Austria. Electronic address: nina.wressnigg@valneva.com.'}, {'ForeName': 'Romana', 'Initials': 'R', 'LastName': 'Hochreiter', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zoihsl', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fritzer', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bézay', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Klingler', 'Affiliation': 'Assign Data Management and Biostatistics, Innsbruck, Austria.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lingnau', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Lundberg', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Meinke', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Larcher-Senn', 'Affiliation': 'Assign Data Management and Biostatistics, Innsbruck, Austria.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Čorbic-Ramljak', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Eder-Lingelbach', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Dubischar', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Bender', 'Affiliation': 'Valneva, Vienna, Austria.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30238-3']
799,32524499,"PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta ® ): Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers.","INTRODUCTION


PF-06881894 is a proposed biosimilar to pegfilgrastim (Neulasta ® ). This study evaluated the pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity, and safety of PF-06881894 vs pegfilgrastim reference products (US- and EU-Neulasta ® ) in healthy volunteers.
METHODS


A phase 1, open-label, randomized, crossover study was conducted to assess the pharmacologic equivalence and safety of a single 6-mg dose of PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU. The primary PD endpoints were area under the effect-versus-time curve for absolute neutrophil count (ANC) from dose administration to 288 h postdose, and maximum observed ANC value among subjects confirmed negative for anti-pegfilgrastim antibodies. Primary PK variables included area under the serum pegfilgrastim-versus-time curve from the time of dose administration to time infinity and maximum observed serum pegfilgrastim concentration. A second phase 1, open-label, randomized (1:1), parallel-group, non-inferiority study was conducted to assess the immunogenicity and safety of multiple 6-mg doses of PF-06881894 versus pegfilgrastim-US. The primary endpoint for the immunogenicity study was the proportion of subjects with both negative baseline and confirmed positive postdose anti-pegfilgrastim antibodies at any time during the study.
RESULTS


Across the single- and multiple-dose studies (N = 153 and N = 420 treated subjects, respectively), demographics for age (18-65 years), male gender (n = 264/573), and white race (n = 423/573) were similar. Three-way PD/PK equivalence of PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU was demonstrated with the primary PD endpoints and primary PK variables being completely contained within the predefined 90% confidence interval acceptance limits (80-125%). The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%). Overall, there were no clinically meaningful differences in safety profiles among or between study groups.
CONCLUSIONS


Single-dose PF-06881894 demonstrated PD/PK equivalence and comparable safety with US- and EU-pegfilgrastim reference products. Multiple-dose PF-06881894 demonstrated immunogenicity non-inferiority to pegfilgrastim-US with comparable safety. Both studies contributed to the totality of evidence supporting biosimilarity.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers: NCT02629289; NCT03273842 (C1221005).",2020,The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%).,"['Healthy Volunteers', '420 treated subjects, respectively), demographics for age (18-65\xa0years), male gender (n\u2009=\u2009264/573), and white race (n\u2009=\u2009423/573', 'healthy volunteers']","['PF-06881894 vs pegfilgrastim reference products (US- and EU-Neulasta ® ', 'pegfilgrastim-US', 'PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU']","['area under the effect-versus-time curve for absolute neutrophil count (ANC', 'pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity, and safety', 'proportion of subjects with both negative baseline and confirmed positive postdose anti-pegfilgrastim antibodies', 'area under the serum pegfilgrastim-versus-time curve from the time of dose administration to time infinity and maximum observed serum pegfilgrastim concentration', 'pharmacologic equivalence and safety', 'PD/PK equivalence', 'immunogenicity and safety', 'confidence interval acceptance limits']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C1171279', 'cui_str': 'Neulasta'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",420.0,0.0810477,The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%).,"[{'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Moosavi', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Borema', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Ewesuedo', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Levy', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'May', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Summers', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Thomas', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA.'}, {'ForeName': 'Hsuan-Ming', 'Initials': 'HM', 'LastName': 'Yao', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA. hsuan-ming.yao@pfizer.com.'}]",Advances in therapy,['10.1007/s12325-020-01387-x']
800,32524500,"Denosumab Versus Zoledronic Acid in Bone Disease Treatment of Newly Diagnosed Multiple Myeloma: An International, Double-Blind, Randomized Controlled Phase 3 Study-Asian Subgroup Analysis.","INTRODUCTION


The primary analysis of a global phase 3 study that evaluated the efficacy and safety of denosumab versus zoledronic acid for preventing skeletal-related events (SREs) in adults with newly diagnosed multiple myeloma (MM) indicated that denosumab was noninferior to zoledronic acid for time to first on-study SREs. Here we present a subgroup analysis to evaluate efficacy and safety in Asian patients.
METHODS


Patients were randomized 1:1 to receive denosumab 120 mg subcutaneously or zoledronic acid intravenously 4 mg every 4 weeks in a double-blind, double-dummy fashion. All patients received standard-of-care first-line antimyeloma treatment. Each patient received either study drug until an estimated 676 patients experienced at least one on-study SRE and the primary efficacy and safety analyses were completed.
RESULTS


Of 1718 total enrolled patients, 196 Asian patients (denosumab, n = 103; zoledronic acid, n = 93) were included in this subgroup analysis. Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48-1.26]). All 194 patients receiving at least one dose of study drug experienced at least one treatment-emergent AE. The most common AEs reported in either group (denosumab, zoledronic acid) were diarrhea (51.0%, 51.1%), nausea (42.2%, 46.7%), and pyrexia (38.2%, 41.3%). Treatment-emergent renal toxicity occurred in 9/102 (8.8%) and 20/92 (21.7%) patients, respectively. Similar rates of positively adjudicated osteonecrosis of the jaw (7 [6.9%] vs 5 [5.4%]) and treatment-emergent hypocalcemia (19 [18.6%] vs 17 [18.5%]) were reported in the denosumab and zoledronic acid groups, respectively.
CONCLUSION


Efficacy and safety outcomes from this Asian subgroup were comparable to those of the full study population. Overall, this analysis supports denosumab as an additional treatment option for standard of care for Asian patients with newly diagnosed MM with lytic bone lesions.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT01345019.",2020,"Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48-1.26]).","['Newly Diagnosed Multiple Myeloma', 'adults with newly diagnosed multiple myeloma (MM', 'Asian patients', 'Patients', 'Asian patients with newly diagnosed MM with lytic bone lesions', '1718 total enrolled patients, 196 Asian patients (denosumab, n\u2009=\u2009103; zoledronic acid, n\u2009=\u200993', 'All 194 patients receiving at least one dose of study drug experienced at least one treatment-emergent AE']","['standard-of-care first-line antimyeloma treatment', 'zoledronic acid', 'Denosumab Versus Zoledronic Acid', 'denosumab versus zoledronic acid', 'denosumab 120\xa0mg subcutaneously or zoledronic acid']","['diarrhea', 'skeletal-related events (SREs', 'treatment-emergent hypocalcemia', 'renal toxicity', 'pyrexia', 'efficacy and safety', 'Efficacy and safety outcomes', 'crude incidence of SREs', 'nausea']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024348', 'cui_str': 'Lysis'}, {'cui': 'C0238792', 'cui_str': 'Bone lesion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",196.0,0.620923,"Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48-1.26]).","[{'ForeName': 'Shang-Yi', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Sung-Soo', 'Initials': 'SS', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Shimizu', 'Affiliation': 'Department of Hematology/Oncology, Higashi Nagoya National Hospital, Nagoya, Japan.'}, {'ForeName': 'Wee Joo', 'Initials': 'WJ', 'LastName': 'Chng', 'Affiliation': 'Department of Hematology-Oncology, National University Cancer Institute, Singapore, National University Health System, Singapore, Republic of Singapore.'}, {'ForeName': 'Cheng-Shyong', 'Initials': 'CS', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, Chang Bing Show Chwan Memorial Hospital, Changhua, Taiwan.'}, {'ForeName': 'Raymond Siu-Ming', 'Initials': 'RS', 'LastName': 'Wong', 'Affiliation': 'Sir Y.K. Pao Centre for Cancer and Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Seasea', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Amgen Asia Holding Ltd., Hong Kong SAR, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Steve W', 'Initials': 'SW', 'LastName': 'Gordon', 'Affiliation': 'Amgen Asia Holding Ltd., Hong Kong SAR, China.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Glennane', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Chang-Ki', 'Initials': 'CK', 'LastName': 'Min', 'Affiliation': ""Department of Hematology, Seoul St. Mary's Hospital, Seoul, Republic of Korea. ckmin@catholic.ac.kr.""}]",Advances in therapy,['10.1007/s12325-020-01395-x']
801,32512930,The Development and Effectiveness of a Clinical Training Violence Prevention Program for Nursing Students.,"The study aimed to develop and evaluate a violence prevention program for nursing students to improve communication self-efficacy, problem-focused coping style, emotion-focused coping style, and the ability to cope with violence. Using an eight-session violence prevention program, the study was designed as quasi experimental, with a pretest, posttest, and follow-up assessment with a nonequivalent control group. Nursing students from the fourth year of a university were selected as participants; 22 students were assigned to the experimental group and 23 to the control group. Data analysis included Chi-square, Fisher's exact test, Levene's Test, Mann-Whitney U-test, and repeated measures ANOVA. Results showed that the experimental group showed significantly higher posttest scores for the problem-focused coping style (F = 20.77,  p  < 0.001), intra-individual and interaction effects for the emotion-focused coping style (F = 12.03,  p  < 0.001), and the ability to cope with violence (U = 70,  p  < 0.001) than the control group. Thus, the workplace violence prevention program was effective for nursing students.",2020,"Results showed that the experimental group showed significantly higher posttest scores for the problem-focused coping style (F = 20.77,  p  < 0.001), intra-individual and interaction effects for the emotion-focused coping style (F = 12.03,  p  < 0.001), and the ability to cope with violence (U = 70,  p  < 0.001) than the control group.","['Nursing students from the fourth year of a university were selected as participants; 22 students', 'nursing students', 'Nursing Students']","['Clinical Training Violence Prevention Program', 'workplace violence prevention program', 'violence prevention program']","['coping style', ""Chi-square, Fisher's exact test, Levene's Test, Mann-Whitney U-test, and repeated measures ANOVA"", 'ability to cope with violence', 'intra-individual and interaction effects for the emotion-focused coping style']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3658335', 'cui_str': 'Workplace Violence'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}, {'cui': 'C0424097', 'cui_str': 'Ability to cope'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]",22.0,0.0137831,"Results showed that the experimental group showed significantly higher posttest scores for the problem-focused coping style (F = 20.77,  p  < 0.001), intra-individual and interaction effects for the emotion-focused coping style (F = 12.03,  p  < 0.001), and the ability to cope with violence (U = 70,  p  < 0.001) than the control group.","[{'ForeName': 'Yunhwa', 'Initials': 'Y', 'LastName': 'Jeong', 'Affiliation': 'Department of Nursing and Kyongbuk Science College, Gyeongsangbuk-do 39913, Korea.'}, {'ForeName': 'Kyunghee', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Keimyung University, Daegu 42601, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17114004']
802,32516769,Amount of Dentifrice and Fluoride Concentration Influence Salivary Fluoride Concentrations and Fluoride Intake by Toddlers.,"The present study evaluated fluoride (F) concentrations in saliva of toddlers after brushing with dentifrices containing different F concentrations, applied in different quantities, and estimated F intake from toothbrushing. The study comprised a double-blind, crossover protocol, in which toddlers (n = 18, 2-3 years old) were randomly assigned into six groups, according to possible combinations of dentifrices (0/550/1,100 ppm F, as NaF) and amounts (rice grain, pea size, and transverse technique). Volunteers used a F-free dentifrice during 1 week. On the 7th day, saliva samples were collected before (baseline), and at 5/15/30/60 min after toothbrushing. All dentifrice expectorated after brushing was collected. F concentrations (saliva and expectorate) were determined with an ion-specific electrode. Data were submitted to ANOVA or Kruskal-Wallis test, followed by Fisher's LSD or Student-Newman-Keuls' tests (p <0.05). Brushing with 550 ppm F dentifrice (pea size or transversal technique) increased the area under the curve (AUC) at similar levels compared to 1,100 ppm F (rice grain). The highest AUC and salivary F at 5 min after brushing were achieved by 1,100 ppm F (pea size), followed by 550 ppm F (transversal technique). Regarding F intake, the highest values were observed for 550 ppm F (transversal technique), followed by 1,100 ppm F (pea size). It is possible to conclude that the amount of dentifrice and F concentration in the product significantly affected both salivary F concentrations and F intake during toothbrushing.",2020,"Brushing with 550 ppm F dentifrice (pea size or transversal technique) increased the area under the curve (AUC) at similar levels compared to 1,100 ppm F (rice grain).","['toddlers (n = 18, 2-3 years old', 'Toddlers']","['Dentifrice and Fluoride', 'F-free dentifrice', 'Brushing with 550 ppm F dentifrice (pea size or transversal technique']","['salivary F concentrations and F intake', 'F concentrations (saliva and expectorate']","[{'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0232515', 'cui_str': 'Spitting'}]",,0.0436303,"Brushing with 550 ppm F dentifrice (pea size or transversal technique) increased the area under the curve (AUC) at similar levels compared to 1,100 ppm F (rice grain).","[{'ForeName': 'Caio', 'Initials': 'C', 'LastName': 'Sampaio', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Alberto Carlos Botazzo', 'Initials': 'ACB', 'LastName': 'Delbem', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Mayra Frasson', 'Initials': 'MF', 'LastName': 'Paiva', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Zen', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Marcelle', 'Initials': 'M', 'LastName': 'Danelon', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Robson Frederico', 'Initials': 'RF', 'LastName': 'Cunha', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Juliano Pelim', 'Initials': 'JP', 'LastName': 'Pessan', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil, juliano.pessan@unesp.br.'}]",Caries research,['10.1159/000503780']
803,32494060,The effect of Virtual Reality on evoked potentials following painful electrical stimuli and subjective pain.,"BACKGROUND


Virtual reality (VR) has been shown to reduce pain, however outcome parameters of previous studies have primarily been of a subjective nature and susceptible to bias. This study investigated the effect of VR on cortical processing of evoked potentials (EPs) and subjectively reported pain. Additionally, we explored whether subjects' demographic and personal characteristics modulated the effect of VR analgesia.
METHODS


Three VR conditions were compared in a randomized cross-over study of 30 healthy volunteers: Passive VR (i.e. no interaction possible with the virtual world), active VR (interactive virtual environment) and no VR (black screen). Subjects received noxious electrical stimuli at random intervals during all conditions. EPs, recorded at Cz, were extracted time locked to stimuli. Pain scores were reported after each condition.
RESULTS


Active VR significantly decreased pain scores and amplitudes of N1 and P3. Passive VR had no analgesic effect. Age was significantly correlated to pain scores, with older subjects demonstrating larger effects of VR. Gender, game experience, and susceptibility for immersion, did not influence VR analgesia.
CONCLUSION


Active VR decreases pre-perceptual and perceptual brain activity following painful electrical stimuli, corresponding with reduced pain experience. VR has potential to serve as a non-pharmacologic treatment for pain, particularly in elderly patients.",2020,"RESULTS


Active VR significantly decreased pain scores and amplitudes of N1 and P3.","['elderly patients', '30 healthy volunteers']","['noxious electrical stimuli', 'VR', 'Virtual Reality', 'Passive VR (i.e. no interaction possible with the virtual world), active VR (interactive virtual environment) and no VR (black screen']","['pain scores', 'pain scores and amplitudes of N1 and P3', 'Active VR decreases pre-perceptual and perceptual brain activity', 'Pain scores', 'cortical processing of evoked potentials (EPs) and subjectively reported pain']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",30.0,0.0186764,"RESULTS


Active VR significantly decreased pain scores and amplitudes of N1 and P3.","[{'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Lier', 'Affiliation': 'Department of Surgery, Radboud university medical center Nijmegen, Nijmegen, The Netherlands. janienkelier@gmail.com.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Oosterman', 'Affiliation': 'Radboud University, Donders Institute for Brain, Cognition and Behaviour, Nijmegen, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Assmann', 'Affiliation': 'Department of Surgery, Radboud university medical center Nijmegen, Nijmegen, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'de Vries', 'Affiliation': 'Department of Surgery, Radboud university medical center Nijmegen, Nijmegen, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'van Goor', 'Affiliation': 'Department of Surgery, Radboud university medical center Nijmegen, Nijmegen, The Netherlands.'}]",Scientific reports,['10.1038/s41598-020-66035-4']
804,32503608,"Efficacy and safety of YinQiSanHuang-antiviral decoction in chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trial.","INTRODUCTION


Chronic hepatitis B (CHB) is a global public health problem. Antiviral therapy is the primary treatment. Studies have shown that a combined therapy of traditional Chinese medicine (TCM) and conventional antiviral drugs has better efficacy than conventional antiviral for treatment of CHB. YinQiSanHuang-antiviral decoction (YQSH) is a TCM compound preparation that has shown an effect on anti-hepatitis B virus and on slowing progression of hepatitis B-related liver diseases. To evaluate the efficacy and safety of YQSH combined with entecavir and its preventive effect on hepatitis B cirrhosis, we designed this randomized, double-blind and placebo-controlled trial. The objective is that the combination of YinQiSanHuang-antiviral decoction with entecavir will reduce the annual incidence of liver fibrosis/cirrhosis to 1%.
METHODS


This is a multicenter, randomized, placebo-controlled, double-blinded trial involving five hospitals. A total of 802 patients are randomly allocated to two groups: the YQSH group (n = 401) or the placebo group (n = 401). The YQSH group receives YQSH with entecavir; the placebo group receives granules of placebo with entecavir. Patients receive treatment for 52 weeks and then are followed up for 52 ± 2 weeks. The primary outcome measure is the annual incidence of cirrhosis. The secondary outcome measures are hepatitis B virus DNA negative rate, hepatitis B surface antigen negative rate, hepatitis B e antigen seroconversion rate, liver function (alanine aminotransferase, aspartate aminotransferase , gamma-glutamyl transferase , alkaline phosphatase , serum albumin, and total bilirubin), spleen thickness, evaluation scores of patients' clinical symptoms, and safety assessment. Outcomes will be assessed at baseline and after treatment.
DISCUSSION


Combination therapy could become a trend for treatment of CHB, and this trial expects to provide credible clinical evidence for the future combination of TCM and conventional antiviral drugs for the treatment of CHB.
TRIAL REGISTRATION


Chinese Clinical Trial Registry: ChiCTR1900021521. Registered on 25 February 2019.",2020,"The secondary outcome measures are hepatitis B virus DNA negative rate, hepatitis B surface antigen negative rate, hepatitis B e antigen seroconversion rate, liver function (alanine aminotransferase, aspartate aminotransferase , gamma-glutamyl transferase , alkaline phosphatase , serum albumin, and total bilirubin), spleen thickness, evaluation scores of patients' clinical symptoms, and safety assessment.","['Chronic hepatitis B (CHB', 'hepatitis B cirrhosis', '802 patients', 'chronic hepatitis B']","['YQSH combined with entecavir', 'Antiviral therapy', 'YinQiSanHuang-antiviral decoction (YQSH', 'entecavir', 'YQSH', 'placebo with entecavir', 'traditional Chinese medicine (TCM', 'YinQiSanHuang-antiviral decoction with entecavir', 'YinQiSanHuang-antiviral decoction', 'placebo']","['efficacy and safety', ""hepatitis B virus DNA negative rate, hepatitis B surface antigen negative rate, hepatitis B e antigen seroconversion rate, liver function (alanine aminotransferase, aspartate aminotransferase , gamma-glutamyl transferase , alkaline phosphatase , serum albumin, and total bilirubin), spleen thickness, evaluation scores of patients' clinical symptoms, and safety assessment"", 'annual incidence of cirrhosis', 'Efficacy and safety']","[{'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0919711', 'cui_str': 'Hepatitis B surface antigen negative'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}]",5.0,0.721903,"The secondary outcome measures are hepatitis B virus DNA negative rate, hepatitis B surface antigen negative rate, hepatitis B e antigen seroconversion rate, liver function (alanine aminotransferase, aspartate aminotransferase , gamma-glutamyl transferase , alkaline phosphatase , serum albumin, and total bilirubin), spleen thickness, evaluation scores of patients' clinical symptoms, and safety assessment.","[{'ForeName': 'Qing-Juan', 'Initials': 'QJ', 'LastName': 'Wu', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Wen-Liang', 'Initials': 'WL', 'LastName': 'Lv', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China. wenlianglv@126.com.""}, {'ForeName': 'Juan-Mei', 'Initials': 'JM', 'LastName': 'Li', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Zhang', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Wen-Hui', 'Initials': 'WH', 'LastName': 'Zhou', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Jiu-Chong', 'Initials': 'JC', 'LastName': 'Wang', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Qing-Nan', 'Initials': 'QN', 'LastName': 'Wang', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Ruo-Xuan', 'Initials': 'RX', 'LastName': 'Zhang', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Si-Tong', 'Initials': 'ST', 'LastName': 'Chen', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Gao-Hui', 'Initials': 'GH', 'LastName': 'Li', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Zheng-Min', 'Initials': 'ZM', 'LastName': 'Cao', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}]",Trials,['10.1186/s13063-020-04395-y']
805,32506278,The effect of systemic erythropoietin and oral prednisolone on recent-onset non-arteritic anterior ischemic optic neuropathy: a randomized clinical trial.,"BACKGROUND


To evaluate the effect of systemic erythropoietin, as well as oral steroids, in the management of recent-onset non-arteritic anterior ischemic optic neuropathy (NAION).
METHOD


Patients diagnosed with NAION within 5 days were randomized into group A (systemic erythropoietin), group B (oral steroids), and group C (control). Group A received 10,000 units of erythropoietin twice a day for 3 days. Group B received oral prednisone 75 mg daily tapered off in 6 weeks.
RESULTS


The mean best-corrected visual acuity (± SD) at the time of presentation was 1 ± 0.56, 1.01 ± 0.6, and 0.94 ± 0.47 logMAR in groups A, B, and C, respectively (P = 0.140); corresponding values at 6-month follow-up were 0.70 ± 0.44, 0.73 ± 0.35, and 0.75 ± 0.39 logMAR, respectively (P = 0.597). Fifty-five percent of patients in group A versus 34.3% in group B and 31.2% in group C had an improvement of at least 3 lines in the best-corrected visual acuity values at the 6th month of follow-up visit (P = 0.04). Peripapillary retinal nerve fiber layers at presentation were 189 ± 58, 193 ± 64, and 199 ± 62 micrometers, respectively (P = 0.779), which decreased to 88 ± 12, 74 ± 25, and 71 ± 18, respectively at 6-month follow-up (P = 0.041).
CONCLUSION


The findings of our study indicate the beneficial effects of systemic erythropoietin in preserving the function and structure of the optic nerve in recent-onset NAION.
TRIAL REGISTRATION


Clinical registration number: IR.SBMU.ORC.REC.1397.18.",2020,Fifty-five percent of patients in group A versus 34.3% in group B and 31.2% in group C had an improvement of at least 3 lines in the best-corrected visual acuity values at the 6th month of follow-up visit (P = 0.04).,['Patients diagnosed with NAION within 5 days'],"['systemic erythropoietin), group B (oral steroids', 'systemic erythropoietin and oral prednisolone', 'erythropoietin', 'systemic erythropoietin', 'oral prednisone']","['visual acuity values', 'mean best-corrected visual acuity (± SD', 'Peripapillary retinal nerve fiber layers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2242711', 'cui_str': 'Arteritic anterior ischemic optic neuropathy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0358513', 'cui_str': 'Prednisolone-containing product in oral dose form'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0442163', 'cui_str': 'Peripapillary'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}]",,0.182408,Fifty-five percent of patients in group A versus 34.3% in group B and 31.2% in group C had an improvement of at least 3 lines in the best-corrected visual acuity values at the 6th month of follow-up visit (P = 0.04).,"[{'ForeName': 'Homayoun', 'Initials': 'H', 'LastName': 'Nikkhah', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahya', 'Initials': 'M', 'LastName': 'Golalipour', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Doozandeh', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Pakravan', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yaseri', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Esfandiari', 'Affiliation': 'Department of Ophthalmology, Northwestern University Feinberg School of Medicine, Chicago, USA. hmdesfandiary@gmail.com.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04781-x']
806,32514040,A registered replication study on oxytocin and trust.,"In an influential paper, Kosfeld et al. (2005) showed that intranasal administration of oxytocin (OT) increases the transfers made by investors in the trust game-suggesting that OT increases trust in strangers. Subsequent studies investigating the role of OT in the trust game found inconclusive effects on the trusting behaviour of investors but these studies deviated from the Kosfeld et al. study in an important way-they did not implement minimal social contact (MSC) between the investors and the trustees in the trust game. Here, we performed a large double-blind and placebo-controlled replication study of the effects of OT on trusting behaviour that yields a power of more than 95% and implements an MSC condition as well as a no-social-contact (NoC) condition. We find no effect of OT on trusting behaviour in the MSC condition. Exploratory post hoc analyses suggest that OT may increase trust in individuals with a low disposition to trust in the NoC condition, but this finding requires confirmation in future research. PROTOCOL REGISTRATION: The stage 1 protocol for this Registered Report was accepted in principle on 19 October 2018. The protocol, as accepted by the journal, can be found at https://doi.org/10.6084/m9.figshare.11980368.",2020,"Exploratory post hoc analyses suggest that OT may increase trust in individuals with a low disposition to trust in the NoC condition, but this finding requires confirmation in future research.",[],"['OT', 'oxytocin', 'oxytocin (OT', 'placebo']",[],[],"[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0573493,"Exploratory post hoc analyses suggest that OT may increase trust in individuals with a low disposition to trust in the NoC condition, but this finding requires confirmation in future research.","[{'ForeName': 'Carolyn H', 'Initials': 'CH', 'LastName': 'Declerck', 'Affiliation': 'Faculty of Business and Economics, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Boone', 'Affiliation': 'Faculty of Business and Economics, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Loren', 'Initials': 'L', 'LastName': 'Pauwels', 'Affiliation': 'Faculty of Business and Economics, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Bodo', 'Initials': 'B', 'LastName': 'Vogt', 'Affiliation': 'Chair in Empirical Economics and Health Economics, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Fehr', 'Affiliation': 'Laboratory for Social and Neural Systems Research, Department of Economics, University of Zurich, Zurich, Switzerland. ernst.fehr@econ.uzh.ch.'}]",Nature human behaviour,['10.1038/s41562-020-0878-x']
807,32515747,Feasibility of a Home-Based Tablet App for Dexterity Training in Multiple Sclerosis: Usability Study.,"BACKGROUND


Persons with multiple sclerosis (MS) often experience dexterous difficulties during the performance of activities of daily living, such as fastening buttons, handling coins, or writing, therefore impacting their health-related quality of life. Mobile health (mHealth) solutions, such as tablet apps, may be used to train impaired dexterous skills. The feasibility of a tablet app-based dexterity home-based intervention in MS (TAD-MS) has not been explored yet in persons with MS.
OBJECTIVE


The aim of this pilot study was to evaluate the feasibility and usability of home-based dexterity training with a tablet app in both persons with MS and healthy subjects.
METHODS


A total of 9 persons with MS, aged 35-71 years, with an Expanded Disability Status Scale score between 2 and 7.5, performed the TAD-MS for 4 weeks, five times a week, with each training session lasting approximately 30 minutes. Participants' impaired dexterity was measured by the Nine-Hole Peg Test. A total of 10 age-matched healthy subjects also tested and rated the usability of the app. Outcome measures were the adherence rate as well as usability measured by the System Usability Scale and a Custom User Engagement Questionnaire (CUEQ).
RESULTS


High feasibility of the tablet app-based dexterity training program was shown by a 97% adherence rate to the training protocol (ie, mean 19.4/20 sessions completed, SD 0.8). High system usability scores (ie, mean 85.39%, SD 11.67) and overall high scores given in the CUEQ (ie, mean 8.2/10, SD 1.4) further point to high usability of the app. Neither demographic variables nor dexterity levels affected the use of the app.
CONCLUSIONS


This pilot study is the first to demonstrate high feasibility and usability of a new tablet app-based dexterity home-based training program among both persons with MS and healthy individuals. Whether this kind of training improves dexterity will need to be evaluated in a randomized controlled trial.",2020,"RESULTS


High feasibility of the tablet app-based dexterity training program was shown by a 97% adherence rate to the training protocol (ie, mean 19.4/20 sessions completed, SD 0.8).","['A total of 10 age-matched healthy subjects', '9 persons with MS, aged 35-71 years', 'persons with MS', 'persons with MS and healthy subjects', 'Persons with multiple sclerosis (MS', 'persons with MS and healthy individuals', 'Multiple Sclerosis']","['new tablet app-based dexterity home-based training program', 'home-based dexterity training', 'tablet app-based dexterity home-based intervention in MS (TAD-MS', 'Home-Based Tablet App']","['Expanded Disability Status Scale score', 'High system usability scores', 'feasibility and usability', 'dexterity', 'adherence rate as well as usability measured by the System Usability Scale and a Custom User Engagement Questionnaire (CUEQ']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0057150', 'cui_str': 'DAT protocol 1'}]","[{'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",9.0,0.0233663,"RESULTS


High feasibility of the tablet app-based dexterity training program was shown by a 97% adherence rate to the training protocol (ie, mean 19.4/20 sessions completed, SD 0.8).","[{'ForeName': 'Judith Jantine Willemijn', 'Initials': 'JJW', 'LastName': 'van Beek', 'Affiliation': 'Neurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.'}, {'ForeName': 'Erwin Everardus Henri', 'Initials': 'EEH', 'LastName': 'van Wegen', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Multiple Sclerosis Center Amsterdam, Amsterdam University Medical Centers, Vrije Universiteit Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Marc Berend', 'Initials': 'MB', 'LastName': 'Rietberg', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Multiple Sclerosis Center Amsterdam, Amsterdam University Medical Centers, Vrije Universiteit Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Nyffeler', 'Affiliation': 'Neurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Bohlhalter', 'Affiliation': 'Neurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.'}, {'ForeName': 'Christian Philipp', 'Initials': 'CP', 'LastName': 'Kamm', 'Affiliation': 'Neurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Nef', 'Affiliation': 'Gerontechnology and Rehabilitation Group, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Vanbellingen', 'Affiliation': 'Neurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.'}]",JMIR mHealth and uHealth,['10.2196/18204']
808,32519221,The 'flash' adhesive study: a randomized crossover trial using an additional adhesive patch to prolong freestyle libre sensor life among youth with type 1 diabetes mellitus.,"AIMS


Although strategies to prevent premature sensor loss for flash glucose monitoring (FGM) systems may have substantial benefit, limited data are available. This study among youth with high-risk type 1 diabetes evaluated whether an additional adhesive patch over FGM sensors would reduce premature sensor loss frequency and not cause additional cutaneous adverse events (AEs).
METHODS


This is a six-month, open-label, randomized crossover trial. Participants were recruited at completion of prior 'Managing Diabetes in a Flash' randomized controlled trial and allocated to three months of Freestyle Libre FGM sensors with either standard adhesive (control) or additional adhesive patches (RockaDex, New Zealand) (intervention), before crossing over to the opposite study arm. Participants self-reported patch use or non-use, premature sensor loss and cutaneous AEs fortnightly via an electronic questionnaire.
RESULTS


Thirty-four participants were enrolled: mean age (± SD) 17.0 (± 2.2) years; mean HbA1c (± SD) 89 (± 16) mmol/mol (10.3% ± 1.4%). The response rate of questionnaires was 77% (314/408). Premature sensor loss was reported in 18% (58/314) of questionnaires: 20% (32/162) from intervention and 17% (26/152) from control (p = 0.56). Thirty-eight percent (118/314) of questionnaires were non-compliant to protocol allocation. However, per-protocol analysis showed similar findings. No significant difference in AEs was reported between compliant adhesive patch use and non-use (6% [5/78] and 3% [3/118], respectively, p = 0.27).
CONCLUSIONS


The adhesive patch investigated in this study does not appear to prevent premature FGM sensor loss. However, the low risk of AEs and low cost of an adhesive patch suggest an individualized approach to their use may still be warranted. Further research is needed to explore alternative strategies to prevent sensor loss.",2020,"No significant difference in AEs was reported between compliant adhesive patch use and non-use (6% [5/78] and 3% [3/118], respectively, p = 0.27).
","['youth with high-risk type 1 diabetes', 'mean age (±\u2009SD) 17.0 (±\u20092.2)\xa0years; mean', 'Thirty-four participants were enrolled', 'youth with type 1 diabetes mellitus']","['additional adhesive patch', 'additional adhesive patch over FGM sensors', 'Freestyle Libre FGM sensors with either standard adhesive (control) or additional adhesive patches (RockaDex, New Zealand) (intervention']","['Premature sensor loss', 'response rate of questionnaires', 'freestyle libre sensor life']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",34.0,0.0932723,"No significant difference in AEs was reported between compliant adhesive patch use and non-use (6% [5/78] and 3% [3/118], respectively, p = 0.27).
","[{'ForeName': 'Brooke L', 'Initials': 'BL', 'LastName': 'Marsters', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Boucher', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Galland', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'de Lange', 'Affiliation': 'Centre for Biostatistics, Division of Health Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Esko J', 'Initials': 'EJ', 'LastName': 'Wiltshire', 'Affiliation': 'Department of Paediatrics and Child Health, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Martin I', 'Initials': 'MI', 'LastName': 'de Bock', 'Affiliation': 'Department of Paediatrics, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Mona M', 'Initials': 'MM', 'LastName': 'Elbalshy', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Tomlinson', 'Affiliation': 'Paediatric Department, Southern District Health Board, Invercargill, New Zealand.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Rayns', 'Affiliation': 'Endocrinology Department, Southern District Health Board, Dunedin, New Zealand.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'MacKenzie', 'Affiliation': 'Paediatric Department, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chan', 'Affiliation': 'Department of Endocrinology and General Medicine, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Wheeler', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand. ben.wheeler@otago.ac.nz.""}]",Acta diabetologica,['10.1007/s00592-020-01556-y']
809,31611612,Nationwide randomised trial evaluating elective neck dissection for early stage oral cancer (SEND study) with meta-analysis and concurrent real-world cohort.,"BACKGROUND


Guidelines remain unclear over whether patients with early stage oral cancer without overt neck disease benefit from upfront elective neck dissection (END), particularly those with the smallest tumours.
METHODS


We conducted a randomised trial of patients with stage T1/T2 N0 disease, who had their mouth tumour resected either with or without END. Data were also collected from a concurrent cohort of patients who had their preferred surgery. Endpoints included overall survival (OS) and disease-free survival (DFS). We conducted a meta-analysis of all six randomised trials.
RESULTS


Two hundred fifty randomised and 346 observational cohort patients were studied (27 hospitals). Occult neck disease was found in 19.1% (T1) and 34.7% (T2) patients respectively. Five-year intention-to-treat hazard ratios (HR) were: OS HR = 0.71 (p = 0.18), and DFS HR = 0.66 (p = 0.04). Corresponding per-protocol results were: OS HR = 0.59 (p = 0.054), and DFS HR = 0.56 (p = 0.007). END was effective for small tumours. END patients experienced more facial/neck nerve damage; QoL was largely unaffected. The observational cohort supported the randomised findings. The meta-analysis produced HR OS 0.64 and DFS 0.54 (p < 0.001).
CONCLUSION


SEND and the cumulative evidence show that within a generalisable setting oral cancer patients who have an upfront END have a lower risk of death/recurrence, even with small tumours.
CLINICAL TRIAL REGISTRATION


NIHR UK Clinical Research Network database ID number: UKCRN 2069 (registered on 17/02/2006), ISCRTN number: 65018995, ClinicalTrials.gov Identifier: NCT00571883.",2019,"The meta-analysis produced HR OS 0.64 and DFS 0.54 (p < 0.001).
","['Two hundred fifty randomised and 346 observational cohort patients were studied (27 hospitals', 'patients with stage T1/T2 N0 disease, who had their mouth tumour resected either with or without END', 'patients with early stage oral cancer without overt neck disease benefit from upfront elective neck dissection (END']",['elective neck dissection'],"['overall survival (OS) and disease-free survival (DFS', 'facial/neck nerve damage; QoL', 'Occult neck disease', 'risk of death/recurrence']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026640', 'cui_str': 'Neoplasm of mouth'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}, {'cui': 'C0558385', 'cui_str': 'Disorder of neck'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0161479', 'cui_str': 'Nerve injury'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0558385', 'cui_str': 'Disorder of neck'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.620858,"The meta-analysis produced HR OS 0.64 and DFS 0.54 (p < 0.001).
","[{'ForeName': 'Iain L', 'Initials': 'IL', 'LastName': 'Hutchison', 'Affiliation': 'Barts Health NHS Trust, London, UK. hutch.london@googlemail.com.'}, {'ForeName': 'Fran', 'Initials': 'F', 'LastName': 'Ridout', 'Affiliation': 'Saving Faces-The Facial Surgery Research Foundation, London, UK.'}, {'ForeName': 'Sharon M Y', 'Initials': 'SMY', 'LastName': 'Cheung', 'Affiliation': 'Saving Faces-The Facial Surgery Research Foundation, London, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'Barking, Havering and Redbridge University Hospitals NHS Trust, Romford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hardee', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Surwald', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Janavikulam', 'Initials': 'J', 'LastName': 'Thiruchelvam', 'Affiliation': 'Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Tim K', 'Initials': 'TK', 'LastName': 'Mellor', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Brennan', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Baldwin', 'Affiliation': 'The Pennine Acute Hospitals NHS Trust, England, UK.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Shaw', 'Affiliation': 'Aintree University Hospital NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Halfpenny', 'Affiliation': 'Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Danford', 'Affiliation': 'Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Whitley', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': ""St George's University Hospitals NHS Foundation Trust, London, UK.""}, {'ForeName': 'Malcolm W', 'Initials': 'MW', 'LastName': 'Bailey', 'Affiliation': 'Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Woodwards', 'Affiliation': 'The Pennine Acute Hospitals NHS Trust, England, UK.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'University Hospital of South Manchester NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'McManners', 'Affiliation': 'NHS Forth Valley, Stirling, UK.'}, {'ForeName': 'Chi-Hwa', 'Initials': 'CH', 'LastName': 'Chan', 'Affiliation': 'Luton and Dunstable Hospital NHS Foundation Trust, Luton, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Burns', 'Affiliation': 'City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Prav', 'Initials': 'P', 'LastName': 'Praveen', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Camilleri', 'Affiliation': 'East and North Hertfordshire NHS Trust, Stevenage, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Avery', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Putnam', 'Affiliation': 'North Cumbria University Hospitals NHS Trust, Carlisle, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'Derby Teaching Hospitals NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Webster', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Smith', 'Affiliation': 'Northampton General Hospital NHS Trust, Northampton, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Edge', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'McVicar', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Grew', 'Affiliation': 'The Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Hislop', 'Affiliation': 'NHS Ayrshire & Arran, Kilmarnock, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Kalavrezos', 'Affiliation': 'University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ian C', 'Initials': 'IC', 'LastName': 'Martin', 'Affiliation': 'City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'University College London, Cancer Research UK & UCL Cancer Trials Centre, London, UK.'}]",British journal of cancer,['10.1038/s41416-019-0587-2']
810,32171812,Suberythemic and erythemic doses of a 308-nm excimer laser treatment of stable vitiligo in combination with topical tacrolimus: A randomized controlled trial.,,2020,,[],"['308-nm excimer laser treatment', 'topical tacrolimus']",[],[],"[{'cui': 'C0392265', 'cui_str': 'Lasers, Excimer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]",[],,0.160899,,"[{'ForeName': 'Jung Min', 'Initials': 'JM', 'LastName': 'Bae', 'Affiliation': ""Department of Dermatology, St Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.""}, {'ForeName': 'Soo Hyun', 'Initials': 'SH', 'LastName': 'Kwon', 'Affiliation': 'Department of Dermatology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Hyun Jeong', 'Initials': 'HJ', 'LastName': 'Ju', 'Affiliation': ""Department of Dermatology, St Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.""}, {'ForeName': 'Hee Young', 'Initials': 'HY', 'LastName': 'Kang', 'Affiliation': 'Department of Dermatology, Ajou University School of Medicine, Suwon, Korea. Electronic address: hykang@ajou.ac.kr.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.03.009']
811,32500194,CT fluoroscopy-guided transforaminal and intra-articular facet steroid injections for the treatment of cervical radiculopathy: injectate distribution patterns and association with clinical outcome.,"OBJECTIVES


To investigate injectate dispersal patterns and their association with therapeutic efficacy during a transforaminal (TFSI) or an intra-articular facet steroid injection (IFSI) to treat cervical radiculopathy.
METHODS


This retrospective study examined the post-intervention cervical spine CT of 56 patients randomized to receive one CT fluoroscopy-guided IFSI (29 patients; 10 (34.5%) males; mean age 45.0 years; SD 8.8 years; range 26-61 years) or TFSI (27 patients; 13 (48.2%) males; mean age 51.1 years; SD 11.2 years; range 29-72 years) (December 2010 to August 2013). The presence of contrast within the intra-articular facet, juxta-articular facet, retrodural, epidural, and foraminal and extraforaminal spaces during IFSI, and within the extraforaminal, foraminal, and epidural spaces during TFSI was assessed. Descriptive data are presented as frequencies. The association between injectate dispersal patterns and therapeutic efficacy, 4-week post-intervention, was assessed with ANCOVA models.
RESULTS


During IFSI, the injectate predominantly spread to the retrodural (62%; 18/29) or juxta-articular (21%; 6/29) space. During TFSI, the injectate predominantly spread to the extraforaminal/foraminal spaces (41%; 11/27) or to the extraforaminal/foraminal/epidural spaces (33%; 9/27). Injectate presence in the juxta-articular (p = .007) or extraforaminal (p < .001) space was a predictor of therapeutic efficacy but not in the foraminal (p = .54), epidural (p = .89), or retrodural (p = .75) space.
CONCLUSIONS


TFSI and IFSI led to preferential extraforaminal and retrodural injectate spread, respectively. Targeting the extraforaminal or juxta-articular facet space improved the clinical efficacy of steroid injections when treating cervical radiculopathy.
KEY POINTS


• During intra-articular facet injection, the injectate spreads from the facet joint to the retrodural space and rarely reaches the epidural and/or foraminal spaces. • Epidural spread of the injectate during an anterolateral transforaminal steroid injection is the least effective for pain relief in patients with cervical radiculopathy. • Injection techniques targeting the extraforaminal or juxta-articular facet space are safer than transforaminal injections and effectively relieve pain in patients with cervical radiculopathy.",2020,"Injectate presence in the juxta-articular (p = .007) or extraforaminal (p < .001) space was a predictor of therapeutic efficacy but not in the foraminal (p = .54), epidural (p = .89), or retrodural (p = .75) space.
","['56 patients randomized to receive one', 'patients with cervical radiculopathy', '29 patients; 10 (34.5%) males; mean age 45.0\xa0years; SD 8.8\xa0years; range 26-61\xa0years) or TFSI (27 patients; 13 (48.2%) males; mean age 51.1\xa0years; SD 11.2\xa0years; range 29-72\xa0years) (December 2010 to August 2013']","['transforaminal (TFSI) or an intra-articular facet steroid injection (IFSI', 'CT fluoroscopy-guided IFSI', 'transforaminal injections', 'steroid injections', 'CT fluoroscopy-guided transforaminal and intra-articular facet steroid injections']","['therapeutic efficacy', 'pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0742186', 'cui_str': 'Cervical radiculopathy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C5191314', 'cui_str': '48.2'}, {'cui': 'C4517531', 'cui_str': '11.2'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",56.0,0.0325887,"Injectate presence in the juxta-articular (p = .007) or extraforaminal (p < .001) space was a predictor of therapeutic efficacy but not in the foraminal (p = .54), epidural (p = .89), or retrodural (p = .75) space.
","[{'ForeName': 'Nathalie J', 'Initials': 'NJ', 'LastName': 'Bureau', 'Affiliation': ""Department of Radiology, Centre hospitalier de l'Université de Montréal (CHUM), 1000 rue Saint-Denis, Montreal, Quebec, H2X 0C1, Canada. nathalie.bureau@umontreal.ca.""}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Moser', 'Affiliation': ""Department of Radiology, Centre hospitalier de l'Université de Montréal (CHUM), 1000 rue Saint-Denis, Montreal, Quebec, H2X 0C1, Canada.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Gouvion', 'Affiliation': ""Department of Radiology, Centre hospitalier de l'Université de Montréal (CHUM), 1000 rue Saint-Denis, Montreal, Quebec, H2X 0C1, Canada.""}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Julien', 'Affiliation': 'Department of Mathematics and Statistics, Université Laval, 1045 avenue de la Médecine, Québec, G1V 0A6, Canada.'}]",European radiology,['10.1007/s00330-020-06974-8']
812,32497779,"Effects of a synbiotic on symptoms, and daily functioning in attention deficit hyperactivity disorder - A double-blind randomized controlled trial.","Some prebiotics and probiotics have been proposed to improve psychiatric symptoms in children with autism. However, few studies were placebo-controlled, and there is no study on persons with an attention deficit hyperactivity disorder (ADHD) diagnosis. Our aim was to study effects of Synbiotic 2000 on psychiatric symptoms and functioning in children and adults with ADHD without an autism diagnosis. Children and adults (n = 182) with an ADHD diagnosis completed the nine weeks randomized double-blind parallel placebo-controlled trial examining effects of Synbiotic 2000 on the primary endpoints ADHD symptoms, autism symptoms and daily functioning, and the secondary endpoint emotion regulation, measured using the questionnaires SNAP-IV, ASRS, WFIRS, SCQ, AQ and DERS-16. Levels at baseline of plasma C-reactive protein and soluble vascular cell adhesion molecule-1 (sVCAM-1), central to leukocyte-endothelial cell adhesion facilitating inflammatory responses in tissues, were measured using Meso Scale Discovery. Synbiotic 2000 and placebo improved ADHD symptoms equally well, and neither active treatment nor placebo had any statistically significant effect on functioning or sub-diagnostic autism symptoms. However, Synbiotic 2000, specifically, reduced sub-diagnostic autism symptoms in the domain restricted, repetitive and stereotyped behaviors in children, and improved emotion regulation in the domain of goal-directed behavior in adults. In children with elevated sVCAM-1 levels at baseline as well as in children without ADHD medication, Synbiotic 2000 reduced both the total score of autism symptoms, and the restricted, repetitive and stereotyped behaviors. In adults with elevated sVCAM-1 at baseline, Synbiotic 2000 significantly improved emotion regulation, both the total score and four of the five subdomains. To conclude, while no definite Synbiotic 2000-specific effect was detected, the analysis of those with elevated plasma sVCAM-1 levels proposed a reduction of autism symptoms in children and an improvement of emotion regulation in adults with ADHD. Trial registration number: ISRCTN57795429.",2020,"Levels at baseline of plasma C-reactive protein and soluble vascular cell adhesion molecule-1 (sVCAM-1), central to leukocyte-endothelial cell adhesion facilitating inflammatory responses in tissues, were measured using Meso Scale Discovery.","['children with autism', 'persons with an attention deficit hyperactivity disorder (ADHD) diagnosis', 'children and adults with ADHD without an autism diagnosis', 'Children and adults (n=182) with an ADHD diagnosis', 'Attention deficit hyperactivity disorder ', 'adults with ADHD']","['placebo', 'Synbiotic 2000 and placebo', 'Synbiotic 2000', 'synbiotic']","['psychiatric symptoms and functioning', 'plasma C-reactive protein and soluble vascular cell adhesion molecule-1 (sVCAM-1), central to leukocyte-endothelial cell adhesion facilitating inflammatory responses', 'emotion regulation', 'total score of autism symptoms', 'reduced sub-diagnostic autism symptoms', 'elevated sVCAM-1 levels', 'ADHD symptoms, autism symptoms and daily functioning, and the secondary endpoint emotion regulation, measured using the questionnaires SNAP-IV, ASRS, WFIRS, SCQ, AQ and DERS-16', 'ADHD symptoms', 'functioning or sub-diagnostic autism symptoms', 'psychiatric symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0470277', 'cui_str': '2000'}]","[{'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1177045', 'cui_str': 'Snap'}]",,0.53757,"Levels at baseline of plasma C-reactive protein and soluble vascular cell adhesion molecule-1 (sVCAM-1), central to leukocyte-endothelial cell adhesion facilitating inflammatory responses in tissues, were measured using Meso Scale Discovery.","[{'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Skott', 'Affiliation': 'Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm, Sweden; Karolinska University Hospital Solna, Center for Molecular Medicine, Stockholm, Sweden; PRIMA Child and Adult Psychiatry, Stockholm, Sweden.'}, {'ForeName': 'Liu L', 'Initials': 'LL', 'LastName': 'Yang', 'Affiliation': 'Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm, Sweden; Karolinska University Hospital Solna, Center for Molecular Medicine, Stockholm, Sweden.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Stiernborg', 'Affiliation': 'Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm, Sweden; Karolinska University Hospital Solna, Center for Molecular Medicine, Stockholm, Sweden.'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Söderström', 'Affiliation': 'PRIMA Child and Adult Psychiatry, Stockholm, Sweden.'}, {'ForeName': 'Joëlle', 'Initials': 'J', 'LastName': 'Rȕegg', 'Affiliation': 'Karolinska University Hospital Solna, Center for Molecular Medicine, Stockholm, Sweden; Uppsala University, Department of Organismal Biology, Uppsala, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schalling', 'Affiliation': 'Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm, Sweden; Karolinska University Hospital Solna, Center for Molecular Medicine, Stockholm, Sweden.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Forsell', 'Affiliation': 'Karolinska Institutet, Department of Global Public Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'MaiBritt', 'Initials': 'M', 'LastName': 'Giacobini', 'Affiliation': 'Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm, Sweden; PRIMA Child and Adult Psychiatry, Stockholm, Sweden.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Lavebratt', 'Affiliation': 'Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm, Sweden; Karolinska University Hospital Solna, Center for Molecular Medicine, Stockholm, Sweden. Electronic address: catharina.lavebratt@ki.se.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.05.056']
813,32504715,Rehabilitation Posture Does Not Affect the Outcome of Arthroscopically Treated Acromioclavicular Dislocation.,"PURPOSE


To assess the effect of the patient's posture (erect or supine) during rehabilitation sessions on pain, function, and the coracoclavicular (CC) distance after arthroscopic treatment of acromioclavicular joint dislocation.
METHODS


Sixty patients with acute type III or V acromioclavicular dislocation injuries were randomly allocated into 2 groups according to their posture during the rehabilitation phase: supine rehabilitation group (SRG) or erect rehabilitation group (ERG). Arthroscopic stabilization with a suspensory fixation device was used in all patients. The visual analog scale (VAS) score was assessed on the first postoperative day and at 1, 3, and 6 months postoperatively. The Constant-Murley score (CMS) was recorded preoperatively and at 3, 6, 12, and 24 months postoperatively. The CC distance was assessed preoperatively; on the first postoperative day; and at 6, 12, and 24 months postoperatively.
RESULTS


No significant differences were found between the 2 groups in terms of the VAS score, CMS, and CC distance changes. A significant improvement over the follow-up phase was identified in the VAS score and CMS in both groups. The CC distance in both groups was significantly reduced from preoperatively (29.34 mm in the ERG and 28.65 mm in the SRG) to the first postoperative day (10.44 mm and 10.11 mm, respectively). However, a statistically significant re-widening of the CC distance (P < .001) occurred within the first 6 months after surgery (13.55 mm in the ERG and 13.50 mm in the SRG) and at 12 months (15.51 mm and 15.80 mm, respectively).
CONCLUSIONS


The patient's posture during early postoperative rehabilitation does not affect the CC distance changes.
LEVEL OF EVIDENCE


Level I, randomized prospective comparative study.",2020,"No significant differences were found between the two groups in terms of the VAS, CMS scores, and CC distance changes.","['Sixty patients with acute AC dislocation injury types, III and V']","['Arthroscopic stabilization with a suspensory fixation device', ""patient's posture (erect or supine"", 'posture during the rehabilitation phase (Supine Rehabilitation Group; SRG, or Erect Rehabilitation Group; ERG']","['coracoclavicular (CC) distance', 'Constant-Murley Score (CMS', 'CC distance', 'Visual Analogue Scale (VAS', 'coracoclavicular distance changes', 'VAS, CMS scores, and CC distance changes', 'pain, function and the CC (Coracoclavicular) distance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0449499', 'cui_str': 'Type of injury'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0441254', 'cui_str': 'Fixation device'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",60.0,0.018762,"No significant differences were found between the two groups in terms of the VAS, CMS scores, and CC distance changes.","[{'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Gameel', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Abdelghafar', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Tarek Mohamed', 'Initials': 'TM', 'LastName': 'Ghandour', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt. Electronic address: tarekghndr@yahoo.com.'}, {'ForeName': 'Begad M', 'Initials': 'BM', 'LastName': 'Samy Abbas', 'Affiliation': 'Physical Medicine, Rheumatology and Rehabilitation Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.05.043']
814,32510754,Effect of Nigella sativa oil supplement on risk factors for cardiovascular diseases in patients with type 2 diabetes mellitus.,"This study aimed to evaluate the effects of Nigella sativa oil on serum level of systemic inflammation, oxidative stress, fasting blood glucose (FBG), and lipid profile in patients with type 2 diabetes mellitus (T2DM). This double-blind randomized clinical trial study was based on 50 patients with T2DM. Patients were allocated randomly to either N. sativa oil or placebo groups. The intervention group received 1,000 mg N. sativa oil as two capsules, daily for 8 weeks, whereas the placebo group received a corresponding placebo. At baseline and the end of the study, 5 ml blood was collected from each patient after 14-hour fasting for measuring serum C-reactive protein (hs-CRP), malondialdehyde (MDA), FBS, and lipid profile. Analyses covariance was performed to compare investigated parameters between two groups, controlled for relevant covariates. Using N. sativa supplement was significantly associated with decrease in FBS (p < .001), triglyceride (p < .001), total cholesterol (p < .001), low-density lipoprotein cholesterol (p < .001), serum hs-CRP, MDA (p < .001) and increase in serum level of high-density lipoprotein cholesterol (p < .001) in intervention group compared with placebo group. Nigella sativa oil supplement has cardiovascular protective effects in patients with T2DM, by improving the lipid profile and glycemia, by reducing the C-reactive protein level and the lipid peroxidation.",2020,"Using N. sativa supplement was significantly associated with decrease in FBS (p < .001), triglyceride (p < .001), total cholesterol (p < .001), low-density lipoprotein cholesterol (p < .001), serum hs-CRP, MDA (p < .001) and increase in serum level of high-density lipoprotein cholesterol (p < .001) in intervention group compared with placebo group.","['patients with T2DM', 'patients with type 2 diabetes mellitus', 'patients with type 2 diabetes mellitus (T2DM', '50 patients with T2DM']","['1,000\u2009mg N. sativa oil', 'Nigella sativa oil', 'Nigella sativa oil supplement', 'sativa oil or placebo', 'placebo']","['total cholesterol', 'serum C-reactive protein (hs-CRP), malondialdehyde (MDA), FBS, and lipid profile', 'low-density lipoprotein cholesterol', 'serum hs-CRP, MDA', 'triglyceride', 'serum level of systemic inflammation, oxidative stress, fasting blood glucose (FBG), and lipid profile', 'cardiovascular protective effects', 'FBS', 'serum level of high-density lipoprotein cholesterol', 'risk factors for cardiovascular diseases']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C3651714', 'cui_str': 'NIGELLA SATIVA SEED OIL'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",50.0,0.281672,"Using N. sativa supplement was significantly associated with decrease in FBS (p < .001), triglyceride (p < .001), total cholesterol (p < .001), low-density lipoprotein cholesterol (p < .001), serum hs-CRP, MDA (p < .001) and increase in serum level of high-density lipoprotein cholesterol (p < .001) in intervention group compared with placebo group.","[{'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Kooshki', 'Affiliation': 'Non-Communicable Diseases Research Center, Department of Nutrition & Biochemistry, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Tofighiyan', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Rastgoo', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mohammad Hassan', 'Initials': 'MH', 'LastName': 'Rakhshani', 'Affiliation': 'Iranian Research Center on Healthy Aging, Department of Biostatistics and Epidemiology, School of Health, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Miri', 'Affiliation': 'Non-Communicable Diseases Research Center, Department of Environmental Health, School of Health, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6707']
815,32514638,Invited Discussion on: Effect of Photobiomodulation on Ecchymosis After Rhinoplasty-A Randomized Single-Blind Controlled Trial.,,2020,,[],['Photobiomodulation'],['Ecchymosis'],[],[],"[{'cui': 'C0013491', 'cui_str': 'Ecchymosis'}]",,0.0949956,,"[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Hafezi', 'Affiliation': 'Iran University of Medical Sciences, St. Fatima Hospital and Burn Research Center, Suite 12, Number 33, Asef St., Zaferanieh, Tehran, 1988893337, Iran. fhafezi32@gmail.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01795-y']
816,32515543,Lower Risk for Severe Hypoglycaemia with Insulin Glargine 300 U/mL vs Glargine 100 U/mL in Participants with Type 1 Diabetes: a Meta-Analysis of 6-Month Phase 3 Clinical Trials.,"Severe hypoglycaemia (SH) remains a challenge to people with type 1 diabetes (T1DM) and new generation basal insulins may improve patient outcomes. This post-hoc meta-analysis explored the risk of SH with insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100) in a pooled population with T1DM from three randomised, multicentre, 6-month similarly designed phase 3 trials: EDITION 4, EDITION JP 1, and EDITION JUNIOR. Endpoints included incidence and time to first occurrence of SH. Among 629 and 626 participants randomised to Gla-300 and Gla-100, HbA 1c  reductions were similar. Fewer participants experienced ≥1 SH event with Gla-300 (6.2%) than Gla-100 (9.3%). From baseline to Month 6, the risk of a first SH event was lower with Gla-300: hazard ratio, 0.65 (95% confidence interval [CI] 0.44-0.98; stratified log-rank test, P = 0.038). SH event rates (relative risk [95% CI]) were numerically lower with Gla-300 versus Gla-100 from baseline to Month 6 (0.80 [0.49-1.29; P = 0.356]) and baseline to Week 8 (0.73 [0.37-1.44; P = 0.369]). Thus, Gla-300 demonstrated similar glycaemic control with lower risk of SH versus Gla-100, particularly during the titration period. This article is protected by copyright. All rights reserved.",2020,SH event rates (relative risk [95% CI]) were numerically lower with Gla-300 versus Gla-100 from baseline to Month 6 (0.80 [0.49-1.29; P = 0.356]) and baseline to Week 8 (0.73 [0.37-1.44; P = 0.369]).,['Participants with Type 1 Diabetes'],"['Glargine 100', 'SH with insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL', 'Insulin Glargine']","['incidence and time to first occurrence of SH', 'Severe hypoglycaemia (SH', '≥1 SH event with Gla-300', 'risk of a first SH event', 'SH event rates']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0663423,SH event rates (relative risk [95% CI]) were numerically lower with Gla-300 versus Gla-100 from baseline to Month 6 (0.80 [0.49-1.29; P = 0.356]) and baseline to Week 8 (0.73 [0.37-1.44; P = 0.369]).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': ""Children's Hospital Auf der Bult, Hannover Medical School, Hannover, Germany.""}, {'ForeName': 'Munehide', 'Initials': 'M', 'LastName': 'Matsuhisa', 'Affiliation': 'Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sussebach', 'Affiliation': 'Sanofi, Frankfurt am Main, Germany.'}, {'ForeName': 'Harmonie', 'Initials': 'H', 'LastName': 'Goyeau', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lauand', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Niemoeller', 'Affiliation': 'Sanofi, Frankfurt am Main, Germany.'}, {'ForeName': 'Geremia B', 'Initials': 'GB', 'LastName': 'Bolli', 'Affiliation': 'Section of Endocrinology and Metabolism, Department of Medicine, Perugia University Medical School, Perugia, PG, Italy.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14109']
817,32517192,Effect of Magnesium Supplementation on Circulating Biomarkers of Cardiovascular Disease.,"(1) Background: Magnesium supplementation may be effective for the prevention of cardiometabolic diseases, but the mechanisms are unclear. Proteomic approaches can assist in identifying the underlying mechanisms. (2) Methods: We collected repeated blood samples from 52 individuals enrolled in a double-blind trial which randomized participants 1:1 to oral magnesium supplementation (400 mg magnesium/day in the form of magnesium oxide) or a matching placebo for 10 weeks. Plasma levels of 91 proteins were measured at baseline with follow-up samples using the Olink Cardiovascular Disease III proximity extension assay panel and were modeled as arbitrary units in a log 2  scale. We evaluated the effect of oral magnesium supplementation for changes in protein levels and the baseline association between serum magnesium and protein levels. The Holm procedure was used to adjust for multiple comparisons. (3) Results: Participants were 73% women, 94% white, and had a mean age of 62. Changes in proteins did not significantly differ between the two intervention groups after correction for multiple comparisons. The most statistically significant effects were on myoglobin [difference -0.319 log 2  units, 95% confidence interval (CI) (-0.550, -0.088),  p =  0.008], tartrate-resistant acid phosphatase type 5 (-0.187, (-0.328, -0.045),  p =  0.011), tumor necrosis factor ligand superfamily member 13B (-0.181, (-0.332, -0.031),  p =  0.019), ST2 protein (-0.198, (-0.363, -0.032),  p =  0.020), and interleukin-1 receptor type 1 (-0.144, (-0.273, -0.015),  p =  0.029). Similarly, none of the associations of baseline serum magnesium with protein levels were significant after correction for multiple comparisons. (4) Conclusions: Although we did not identify statistically significant effects of oral magnesium supplementation in this relatively small study, this study demonstrates the value of proteomic approaches for the investigation of mechanisms underlying the beneficial effects of magnesium supplementation. Clinical Trials Registration: ClinicalTrials.gov NCT02837328.",2020,"The most statistically significant effects were on myoglobin [difference -0.319 log 2  units, 95% confidence interval (CI) (-0.550, -0.088),  p =  0.008], tartrate-resistant acid phosphatase type 5 (-0.187, (-0.328, -0.045),  p =  0.011), tumor necrosis factor ligand superfamily member 13B (-0.181, (-0.332, -0.031),  p =  0.019), ST2 protein (-0.198, (-0.363, -0.032),  p =  0.020), and interleukin-1 receptor type 1 (-0.144, (-0.273, -0.015),  p =  0.029).","['Participants were 73% women, 94% white, and had a mean age of 62', '52 individuals enrolled']","['Magnesium Supplementation', 'oral magnesium supplementation (400 mg magnesium/day in the form of magnesium oxide) or a matching placebo', 'oral magnesium supplementation', 'Magnesium supplementation']","['Plasma levels of 91 proteins', 'Circulating Biomarkers of Cardiovascular Disease', 'ST2 protein', 'tartrate-resistant acid phosphatase type']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1096534', 'cui_str': 'Magnesium supplement therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0024477', 'cui_str': 'Magnesium Oxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0450499', 'cui_str': 'ST2'}, {'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",73.0,0.469746,"The most statistically significant effects were on myoglobin [difference -0.319 log 2  units, 95% confidence interval (CI) (-0.550, -0.088),  p =  0.008], tartrate-resistant acid phosphatase type 5 (-0.187, (-0.328, -0.045),  p =  0.011), tumor necrosis factor ligand superfamily member 13B (-0.181, (-0.332, -0.031),  p =  0.019), ST2 protein (-0.198, (-0.363, -0.032),  p =  0.020), and interleukin-1 receptor type 1 (-0.144, (-0.273, -0.015),  p =  0.029).","[{'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Alonso', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Lin Y', 'Initials': 'LY', 'LastName': 'Chen', 'Affiliation': 'Cardiovascular Division, Department of Medicine, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Kyle D', 'Initials': 'KD', 'LastName': 'Rudser', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Faye L', 'Initials': 'FL', 'LastName': 'Norby', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN 55454, USA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Rooney', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21287, USA.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Lutsey', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN 55454, USA.'}]",Nutrients,['10.3390/nu12061697']
818,32529735,Re: Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy for the treatment of mild-to-moderate endometriosis: randomised controlled trial.,,2020,,['mild-to-moderate endometriosis'],['Re: Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy'],[],"[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0018880', 'cui_str': 'Helium'}]",[],,0.0688023,,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hirsch', 'Affiliation': ""Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'James M N', 'Initials': 'JMN', 'LastName': 'Duffy', 'Affiliation': ""Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Farquhar', 'Affiliation': 'Cochrane Gynaecology and Fertility Group, Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16330']
819,32533819,Lisdexamfetamine Alters BOLD-fMRI Activations Induced by Odor Cues in Impulsive Children.,"INTRODUCTION


Lisdexamfetamine (LDX) is a drug used to treat ADHD/impulsive patients. Impulsivity is known to affect inhibitory, emotional and cognitive function. On the other hand, smell and odor processing are known to be affected by neurological disorders, as they are modulators of addictive and impulsive behaviors specifically. We hypothesize that, after LDX ingestion, inhibitory pathways of the brain would change, and complementary behavioral regulation mechanisms would appear to regulate decision-making and impulsivity.
METHODS


20 children were studied in an aleatory crossover study. Imaging of BOLD-fMRI activity, elicited by olfactory stimulation in impulsive children, was performed after either LDX or placebo ingestion.
RESULTS


Findings showed that all subjects who underwent odor stimulation presented activations of similar intensities in the olfactory centers of the brain. This contrasted with inhibitory regions of the brain such as the cingulate cortex and frontal lobe regions, which demonstrated changed activity patterns and intensities. While some differences between the placebo and medicated states were found in motor areas, precuneus, cuneus, calcarine, supramarginal, cerebellum and posterior cingulate cortex, the main changes were found in frontal, temporal and parietal cortices. When comparing olfactory cues separately, pleasant food smells like chocolate seemed not to present large differences between the medicated and placebo scenarios, when compared to non-food-related smells.
CONCLUSION


It was demonstrated that LDX, first, altered the inhibitory pathways of the brain, secondly it increased activity in several brain regions which were not activated by smell in drug-naïve patients, and thirdly, it facilitated a complementary behavioral regulation mechanism, run by the cerebellum, which regulated decision-making and impulsivity in motor and frontal structures.",2020,"While some differences between the placebo and medicated states were found in motor areas, precuneus, cuneus, calcarine, supramarginal, cerebellum and posterior cingulate cortex, the main changes were found in frontal, temporal and parietal cortices.","['20 children', 'impulsive children']","['Lisdexamfetamine', 'Lisdexamfetamine (LDX', 'placebo']","['motor areas, precuneus, cuneus, calcarine, supramarginal, cerebellum and posterior cingulate cortex']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}]","[{'cui': 'C1873633', 'cui_str': 'Lisdexamfetamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0152307', 'cui_str': 'Structure of cuneus'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate Gyri'}]",20.0,0.0514171,"While some differences between the placebo and medicated states were found in motor areas, precuneus, cuneus, calcarine, supramarginal, cerebellum and posterior cingulate cortex, the main changes were found in frontal, temporal and parietal cortices.","[{'ForeName': 'Silvia S Hidalgo', 'Initials': 'SSH', 'LastName': 'Tobón', 'Affiliation': 'Imaging Department, Infant Hospital of Mexico, Federico Gómez, 06720 Ciudad de México, CDMX, Mexico.'}, {'ForeName': 'Pilar Dies', 'Initials': 'PD', 'LastName': 'Suárez', 'Affiliation': 'Imaging Department, Infant Hospital of Mexico, Federico Gómez, 06720 Ciudad de México, CDMX, Mexico.'}, {'ForeName': 'Eduardo Barragán', 'Initials': 'EB', 'LastName': 'Pérez', 'Affiliation': 'Neurology Department, Infant Hospital of Mexico, Federico Gómez, 06720 Ciudad de México, CDMX, Mexico.'}, {'ForeName': 'Javier M Hernández', 'Initials': 'JMH', 'LastName': 'López', 'Affiliation': 'Faculty of Mathematical and Physical Sciences, Benemérita Universidad Autónoma de Puebla (BUAP), C.P. 72570, Puebla, Mexico.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'García', 'Affiliation': 'Department of Cardiac Sciences, Stephenson Cardiac Imaging Centre, Calgary University, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'Benito', 'Initials': 'B', 'LastName': 'de Celis Alonso', 'Affiliation': 'Faculty of Mathematical and Physical Sciences, Benemérita Universidad Autónoma de Puebla (BUAP), C.P. 72570, Puebla, Mexico.'}]",CNS & neurological disorders drug targets,['10.2174/1871527319666200613222502']
820,32533949,Omidenepag Isopropyl Versus Latanoprost in Primary Open-Angle Glaucoma and Ocular Hypertension: The Phase 3 AYAME Study.,"PURPOSE


To evaluate the efficacy and safety of omidenepag isopropyl (OMDI), a selective, non-prostaglandin, prostanoid EP2 receptor agonist, in Japanese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).
DESIGN


Phase III, randomized, investigator-masked, active-controlled, parallel-group, noninferiority study (ClinicalTrials.govNCT02623738).
METHODS


After a washout period of 1-4 weeks, eligible patients were randomized (1:1) to OMDI 0.002% or latanoprost 0.005% once daily for 4 weeks. Intraocular pressure (IOP) was measured at 9:00 AM, 1:00 PM, and 5:00 PM at weeks 1, 2, and 4. The primary endpoint was the change from baseline in mean diurnal IOP at week 4. The noninferiority margin for OMDI versus latanoprost was 1.5 mm Hg. Adverse events (AEs) were recorded.
RESULTS


Of the 190 patients randomized, 189 had at least 1 post-baseline IOP measurement. At baseline, patients who received OMDI or latanoprost had a mean ± SD diurnal IOP of 23.78 ± 1.73 mm Hg and 23.40 ± 1.51 mm Hg, respectively. At week 4, least-squares mean ± SE reduction in IOP from baseline with OMDI (-5.93 ± 0.23 mm Hg) was noninferior to that of latanoprost (-6.56 ± 0.22 mm Hg; 95% confidence interval between groups: 0.01-1.26). The most frequently reported treatment-related ocular AEs (OMDI vs latanoprost) were conjunctival hyperemia (23/94 patients [24.5%] vs 10/96 patients [10.4%]), corneal thickening (11/94 patients [11.7%] vs 1/96 patients [1.0%]), and punctate keratitis (0/94 patients vs 5/96 patients [5.2%]). No serious AEs were observed in either group, and there were no discontinuations related to the study drug.
CONCLUSIONS


OMDI 0.002% was noninferior to latanoprost 0.005% in reducing IOP in patients with OHT or POAG and was well tolerated.",2020,The most frequently reported treatment-related ocular AEs (OMDI versus latanoprost) were conjunctival hyperemia (,"['190 patients randomized, 189 had at least 1 post-baseline IOP measurement', 'Primary Open-angle Glaucoma and Ocular Hypertension', 'Japanese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT']","['Omidenepag Isopropyl Versus Latanoprost', 'omidenepag isopropyl (OMDI', 'OMDI or latanoprost', 'OMDI 0.002% or latanoprost', 'latanoprost']","['mean diurnal IOP', 'conjunctival hyperemia ', 'serious AEs', 'corneal thickening', 'tolerated', 'punctate keratitis', 'mean diurnal IOP (±SD', 'Adverse events (AEs', 'Intraocular pressure (IOP']","[{'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C5139819', 'cui_str': 'omidenepag isopropyl'}, {'cui': 'C0090306', 'cui_str': 'latanoprost'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3160915', 'cui_str': 'Corneal thickening'}, {'cui': 'C0259799', 'cui_str': 'Superficial punctate keratitis'}]",190.0,0.21222,The most frequently reported treatment-related ocular AEs (OMDI versus latanoprost) were conjunctival hyperemia (,"[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Aihara', 'Affiliation': 'Department of Ophthalmology, University of Tokyo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Fenghe', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Santen Inc., Emeryville, California, USA. Electronic address: fenghe_lu@hotmail.com.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Kawata', 'Affiliation': 'Santen Pharmaceutical Co. Ltd., Osaka, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Iwata', 'Affiliation': 'Santen Inc., Emeryville, California, USA; Santen Pharmaceutical Co. Ltd., Osaka, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Odani-Kawabata', 'Affiliation': 'Santen Inc., Emeryville, California, USA; Santen Pharmaceutical Co. Ltd., Osaka, Japan.'}, {'ForeName': 'Naveed K', 'Initials': 'NK', 'LastName': 'Shams', 'Affiliation': 'Santen Inc., Emeryville, California, USA; Santen Pharmaceutical Co. Ltd., Osaka, Japan.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.003']
821,32539224,Efficacy and safety of sodium-glucose co-transporter 2 inhibition according to left ventricular ejection fraction in DAPA-HF.,"AIMS


The aim of this study was to examine whether left ventricular ejection fraction (LVEF) modified efficacy and safety of dapagliflozin 10 mg compared with placebo in the 4744 patients with LVEF ≤40% randomized in the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF).
METHODS AND RESULTS


We examined whether LVEF, analysed categorically or continuously, modified the effect of dapagliflozin. The primary efficacy outcome was the composite of a worsening heart failure (HF) event (unplanned HF hospitalization/an urgent HF visit requiring intravenous therapy) or cardiovascular death. Mean LVEF was 31.1% and LVEF categories analysed were: <26% (n = 1143), 26-30% (n = 1018), 31-35% (n = 1187), and >35% (n = 1396). Each 5% decrease in LVEF was associated with a higher risk of the primary outcome [hazard ratio (HR) 1.18; 95% confidence interval (CI) 1.13-1.24]. The benefit of dapagliflozin was consistent across the spectrum of LVEF: the dapagliflozin vs. placebo HR was 0.75 (95% CI 0.59-0.95) for LVEF <26%, 0.75 (0.57-0.98) for LVEF 26-30%, 0.67 (0.51-0.89) for LVEF 31-35%, and 0.83 (0.63-1.09) for LVEF >35% (P for interaction = 0.762). Similarly, the effect of dapagliflozin on the components of the primary endpoint was not modified by baseline LVEF (P for interaction for cardiovascular death = 0.974, and for worsening HF = 0.161). Safety of dapagliflozin was also consistent across the range of LVEF and neither efficacy nor safety were modified by diabetes status.
CONCLUSION


Left ventricular ejection fraction was a significant predictor of hospitalization and mortality in patients with HF with reduced ejection fraction but did not modify the beneficial effect of dapagliflozin, overall or separately, in patients with and without diabetes.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT03036124.",2020,"Safety of dapagliflozin was also consistent across the range of LVEF and neither efficacy nor safety were modified by diabetes status.
",['4744 patients with LVEF\u2009≤40% randomized in the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF'],"['sodium-glucose co-transporter 2 inhibition', 'dapagliflozin', 'LVEF', 'left ventricular ejection fraction (LVEF', 'placebo']","['hospitalization and mortality', 'LVEF', 'Mean LVEF', 'composite of a worsening heart failure (HF) event (unplanned HF hospitalization/an urgent HF visit requiring intravenous therapy) or cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0455142', 'cui_str': 'Intravenous therapy'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",4744.0,0.309689,"Safety of dapagliflozin was also consistent across the range of LVEF and neither efficacy nor safety were modified by diabetes status.
","[{'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Dewan', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'National University of Cordoba, Cordoba, Argentina.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics & Medical Informatics, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'VA Medical Center, University of Minnesota, MN, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bělohlávek', 'Affiliation': '2nd Department of Internal Medicine, Cardiovascular Medicine, General University Hospital, Charles University in Prague, Czech Republic.'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Chopra', 'Affiliation': 'Department of Cardiology, Max Super Specialty Hospital, New Delhi, India.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Dukát', 'Affiliation': 'Department of Internal Medicine, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kitakaze', 'Affiliation': 'Cardiovascular Division of Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Montreal Heart Institute and Université de Montreal, Montreal, Canada.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Clinical Medicine, Herlev-Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Pham Nguyen', 'Initials': 'PN', 'LastName': 'Vinh', 'Affiliation': 'Department of Internal Medicine, Tan Tao University, Tan Duc city, Vietnam.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1867']
822,32543439,Use of a Machine Learning Program to Correctly Triage Incoming Text Messaging Replies From a Cardiovascular Text-Based Secondary Prevention Program: Feasibility Study.,"BACKGROUND


SMS text messaging programs are increasingly being used for secondary prevention, and have been shown to be effective in a number of health conditions including cardiovascular disease. SMS text messaging programs have the potential to increase the reach of an intervention, at a reduced cost, to larger numbers of people who may not access traditional programs. However, patients regularly reply to the SMS text messages, leading to additional staffing requirements to monitor and moderate the patients' SMS text messaging replies. This additional staff requirement directly impacts the cost-effectiveness and scalability of SMS text messaging interventions.
OBJECTIVE


This study aimed to test the feasibility and accuracy of developing a machine learning (ML) program to triage SMS text messaging replies (ie, identify which SMS text messaging replies require a health professional review).
METHODS


SMS text messaging replies received from 2 clinical trials were manually coded (1) into ""Is staff review required?"" (binary response of yes/no); and then (2) into 12 general categories. Five ML models (Naïve Bayes, OneVsRest, Random Forest Decision Trees, Gradient Boosted Trees, and Multilayer Perceptron) and an ensemble model were tested. For each model run, data were randomly allocated into training set (2183/3118, 70.01%) and test set (935/3118, 29.98%). Accuracy for the yes/no classification was calculated using area under the receiver operating characteristics curve (AUC), false positives, and false negatives. Accuracy for classification into 12 categories was compared using multiclass classification evaluators.
RESULTS


A manual review of 3118 SMS text messaging replies showed that 22.00% (686/3118) required staff review. For determining need for staff review, the Multilayer Perceptron model had highest accuracy (AUC 0.86; 4.85% false negatives; and 4.63% false positives); with addition of heuristics (specified keywords) fewer false negatives were identified (3.19%), with small increase in false positives (7.66%) and AUC 0.79. Application of this model would result in 26.7% of SMS text messaging replies requiring review (true + false positives). The ensemble model produced the lowest false negatives (1.43%) at the expense of higher false positives (16.19%). OneVsRest was the most accurate (72.3%) for the 12-category classification.
CONCLUSIONS


The ML program has high sensitivity for identifying the SMS text messaging replies requiring staff input; however, future research is required to validate the models against larger data sets. Incorporation of an ML program to review SMS text messaging replies could significantly reduce staff workload, as staff would not have to review all incoming SMS text messages. This could lead to substantial improvements in cost-effectiveness, scalability, and capacity of SMS text messaging-based interventions.",2020,"SMS text messaging programs have the potential to increase the reach of an intervention, at a reduced cost, to larger numbers of people who may not access traditional programs.",[],"['machine learning (ML) program', 'Machine Learning Program']","['false negatives', 'receiver operating characteristics curve (AUC), false positives, and false negatives', 'false positives']",[],"[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0086858', 'cui_str': 'Programmed Learning'}]","[{'cui': 'C0205558', 'cui_str': 'False negative'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205557', 'cui_str': 'False positive'}]",,0.0500675,"SMS text messaging programs have the potential to increase the reach of an intervention, at a reduced cost, to larger numbers of people who may not access traditional programs.","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Lowres', 'Affiliation': 'Heart Research Institute, Sydney, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Duckworth', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Redfern', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Aravinda', 'Initials': 'A', 'LastName': 'Thiagalingam', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Clara K', 'Initials': 'CK', 'LastName': 'Chow', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}]",JMIR mHealth and uHealth,['10.2196/19200']
823,32207158,Portion-control intervention for people with serious mental illness: A feasibility study.,"PURPOSE


Portion control can be an effective weight-loss strategy for people with serious mental illnesses (SMI). This study aimed to examine the feasibility of portion-control intervention (PCI) for people with SMI.
DESIGN AND METHODS


A randomized experimental design was used. The PCI group received weekly, telephone-delivered behavioral counseling over 12 weeks. Newsletter group received monthly newsletters regarding healthy eating. Descriptive statistics were used to analyze data collected at baseline and at 12 weeks.
FINDINGS


The acceptability of the PCI and significant decreases in waist circumference among the participants of the PCI group were reported.
PRACTICE IMPLICATIONS


Simple and structured guidelines to manage portion size, akin to those featured in our PCI, can benefit those with SMI.",2020,"Simple and structured guidelines to manage portion size, akin to those featured in our PCI, can benefit those with SMI.","['people with serious mental illness', 'people with SMI', 'people with serious mental illnesses (SMI']","['Portion-control intervention', 'portion-control intervention (PCI', 'telephone-delivered behavioral counseling', 'monthly newsletters regarding healthy eating']",['waist circumference'],"[{'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling (procedure)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}]","[{'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]",,0.0618749,"Simple and structured guidelines to manage portion size, akin to those featured in our PCI, can benefit those with SMI.","[{'ForeName': 'Heeyoung', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Health and Community Systems, University of Pittsburgh School of Nursing, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Kane', 'Affiliation': 'Department of Health and Community Systems, University of Pittsburgh School of Nursing, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Sereika', 'Affiliation': 'Department of Health and Community Systems, University of Pittsburgh School of Nursing, Pittsburgh, Pennsylvania.'}]",Perspectives in psychiatric care,['10.1111/ppc.12502']
824,32500519,The impact of athletic clothing style and body awareness on motor performance in women.,"The type of clothing worn, revealing versus concealing, can affect the performance of women on cognitive tasks. This difference in performance may arise because of changes in body awareness that may draw cognitive resources from the goal task. The present study investigated the influence of the style of athletic clothing and body awareness on visual-motor performance in women. Participants (women ages 18-35 years) were randomly assigned to wear tight and revealing (TR group, n = 40) or loose and concealing (LC group, n = 40) athletic clothing. All participants completed the same visual-motor aiming task to assess spatiotemporal measures of motor performance. In addition to the clothing, participants were primed to be conscious of their bodies via measurements of height, weight, and waist circumference; photographs taken of their bodies; a computerized body-size distortion task; and a mirror in the testing chamber. Results revealed that the TR group had increased movement time variability and did not show performance improvements relative to the LC group. These differences suggest that style of clothing may influence motor performance in women by reallocating cognitive resources towards the body and away from the motor task at hand. This research highlights the interactions between cognitive and motor processes and, potentially, the importance of considering the impact of clothing on performance in many different contexts.",2020,Results revealed that the TR group had increased movement time variability and did not show performance improvements relative to the LC group.,"['Participants (women ages 18-35 years', 'women']","['wear tight and revealing (TR group, n = 40) or loose and concealing (LC group, n = 40) athletic clothing', 'athletic clothing and body awareness', 'athletic clothing style and body awareness']","['visual-motor performance', 'movement time variability', 'motor performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205407', 'cui_str': 'Loose'}, {'cui': 'C0443189', 'cui_str': 'Concealed'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",40.0,0.11005,Results revealed that the TR group had increased movement time variability and did not show performance improvements relative to the LC group.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Department of Psychology, Faculty of Arts & Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Sabiston', 'Affiliation': 'Mental Health and Physical Activity Research Centre, Faculty of Kinesiology & Physical Education, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Karlinsky', 'Affiliation': 'Centre for Motor Control, Faculty of Kinesiology & Physical Education, University of Toronto, 55 Harbord Street, Toronto, Ontario, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Manzone', 'Affiliation': 'Centre for Motor Control, Faculty of Kinesiology & Physical Education, University of Toronto, 55 Harbord Street, Toronto, Ontario, Canada.'}, {'ForeName': 'Heather F', 'Initials': 'HF', 'LastName': 'Neyedli', 'Affiliation': 'Kinesiology, School of Health and Human Performance, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Timothy N', 'Initials': 'TN', 'LastName': 'Welsh', 'Affiliation': 'Centre for Motor Control, Faculty of Kinesiology & Physical Education, University of Toronto, 55 Harbord Street, Toronto, Ontario, Canada. t.welsh@utoronto.ca.'}]",Psychonomic bulletin & review,['10.3758/s13423-020-01755-2']
825,32497454,The effect of low-volume high-intensity interval training on cardiometabolic health and psychological responses in overweight/obese middle-aged men.,"High-intensity interval training (HIIT) has been proposed as a time-efficient exercise protocol to improve metabolic health, but direct comparisons with higher-volume moderate-intensity continuous training (MICT) under unsupervised settings are limited. This study compared low-volume HIIT and higher-volume MICT interventions on cardiometabolic and psychological responses in overweight/obese middle-aged men. Twenty-four participants (age: 48.1±5.2yr; BMI: 25.8±2.3kg·m -2 ) were randomly assigned to undertake either HIIT (10 X 1-min bouts of running at 80-90% HR max  separated by 1-min active recovery) or MICT (50-min continuous jogging/brisk walking at 65-70% HR max ) for 3 sessions/week for 8 weeks (2-week supervised + 6-week unsupervised training). Both groups showed similar cardiovascular fitness (VO 2max ) improvement (HIIT: 32.5±5.6 to 36.0±6.2; MICT: 34.3±6.0 to 38.2±5.1mL kg -1  min -1 , p < 0.05) and %fat loss (HIIT: 24.5±3.4 to 23.2±3.5%; MICT: 23.0±4.3 to 21.5±4.1%, p< 0.05) over the 8-week intervention. Compared to baseline, MICT significantly decreased weight and waist circumference. No significant group differences were observed for blood pressure and cardiometabolic blood markers such as lipid profiles, fasting glucose and glycated haemoglobin. Both groups showed similar enjoyment levels and high unsupervised adherence rates (>90%). Our findings suggest that low-volume HIIT can elicit a similar improvement of cardiovascular fitness as traditional higher-volume MICT in overweight/obese middle-aged men.",2020,Both groups showed similar cardiovascular fitness (VO 2max ) improvement (HIIT: 32.5±5.6 to 36.0±6.2; MICT: 34.3±6.0 to 38.2±5.1mL ,"['overweight/obese middle-aged men', 'Twenty-four\xa0participants (age: 48.1±5.2yr; BMI:\xa025.8±2.3kg·m -2 ', 'overweight/obese middle-aged\xa0men']","['High-intensity\xa0interval training (HIIT', 'low-volume\xa0HIIT and higher-volume\xa0MICT interventions', 'HIIT (10 X 1-min bouts of running at\xa080-90', 'low-volume high-intensity interval training', 'MICT']","['fat loss ', 'cardiometabolic health and psychological responses', 'weight and waist circumference', 'cardiovascular fitness\xa0(VO 2max )\xa0improvement', 'cardiovascular fitness', 'enjoyment levels and high unsupervised adherence rates', 'blood pressure and cardiometabolic blood markers such as lipid profiles, fasting glucose and glycated haemoglobin', 'cardiometabolic and psychological responses']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",-2.0,0.0226287,Both groups showed similar cardiovascular fitness (VO 2max ) improvement (HIIT: 32.5±5.6 to 36.0±6.2; MICT: 34.3±6.0 to 38.2±5.1mL ,"[{'ForeName': 'Eric Tsz-Chun', 'Initials': 'ET', 'LastName': 'Poon', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong , Shatin, Hong Kong.'}, {'ForeName': 'Jonathan Peter', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia Okanagan , Kelowna, BC, Canada.'}, {'ForeName': 'Cindy Hui-Ping', 'Initials': 'CH', 'LastName': 'Sit', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong , Shatin, Hong Kong.'}, {'ForeName': 'Stephen Heung-Sang', 'Initials': 'SH', 'LastName': 'Wong', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong , Shatin, Hong Kong.'}]",Journal of sports sciences,['10.1080/02640414.2020.1766178']
826,32497489,Tranexamic Acid Is Associated With Improved Operative Field in Orthognathic Surgery.,"PURPOSE


In the past, both tranexamic acid and dexmedetomidine have been used separately to decrease intraoperative blood loss during orthognathic surgery. However, their combined use in the same setting has never been prospectively evaluated. The present study was conducted to evaluate the effect of tranexamic acid on operative field visibility and blood loss during orthognathic surgery after dexmedetomidine-induced hypotensive anesthesia.
PATIENTS AND METHODS


The present prospective, randomized clinical trial included patients who had undergone orthognathic surgery under general anesthesia. The patients were divided into 2 groups. The dexmedetomidine and tranexamic (DT) group received an intravenous bolus of tranexamic acid (15 mg/kg) and intravenous dexmedetomidine (0.25 to 0.7 μg/kg/hr) as maintenance infusion. The dexmedetomidine (DS) group received only intravenous dexmedetomidine at the same dosage. All the patients received a bolus dose of intravenous dexmedetomidine (1 μg/kg) before the start of anesthesia induction. The operating surgeon rated the quality of the surgical visual field every 15 minutes using the Fromme ordinal scale. Intraoperative blood loss was estimated using the modified gross formula. The operating surgeon's satisfaction was assessed using a Likert scale. Data were analyzed using SPSS, version 22.0 (IBM Corp, Armonk, NY). Kolmogorov-Smirnov tests were used to assess the normality of the measured data, and categorical variables were analyzed using the χ 2  or Fischer exact test.
RESULTS


The study sample included 36 patients, with a mean age of 23.67 ± 11.298 years in the DS group and 20.28 ± 3.286 years in the DT group. Of the patients in the DS and DT groups, 66.66 and 61.11% were male, respectively. No statistically significant differences were found in the baseline characteristics between the 2 treatment groups. The surgeon reported a significantly better surgical visual field in the DT group compared with that in the DS group (P = .001). Also, the intraoperative blood loss significantly less in the DT group (231.11 ± 137.64 mL vs 360.17 ± 187.86 mL; P = .025).
CONCLUSIONS


Tranexamic acid improved surgical field visibility and reduced intraoperative blood loss when administered in conjunction with dexmedetomidine during orthognathic surgery under controlled hypotensive anesthesia.",2020,"Also, the intraoperative blood loss significantly less in the DT group (231.11 ± 137.64 ","['orthognathic surgery after dexmedetomidine-induced hypotensive anesthesia', '36 patients, with a mean age of 23.67\xa0±\xa011.298\xa0years in the DS group and 20.28\xa0±\xa03.286\xa0years in the DT group', 'Orthognathic Surgery', 'patients who had undergone orthognathic surgery under general anesthesia']","['dexmedetomidine (DS', 'tranexamic acid and dexmedetomidine', 'Tranexamic Acid', 'dexmedetomidine and tranexamic (DT', 'tranexamic acid', 'dexmedetomidine', 'Tranexamic acid']","['operative field visibility and blood loss', 'surgical field visibility and reduced intraoperative blood loss', 'surgical visual field', 'intraoperative blood loss', 'Intraoperative blood loss']","[{'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}]",36.0,0.0629391,"Also, the intraoperative blood loss significantly less in the DT group (231.11 ± 137.64 ","[{'ForeName': 'Harjinder', 'Initials': 'H', 'LastName': 'Sharma', 'Affiliation': 'Junior Resident, Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Professor, Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Bhatia', 'Affiliation': 'Additional Professor, Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India. Electronic address: nidhi.bhatia75@gmail.com.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Rattan', 'Affiliation': 'Additional Professor, Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Sethi', 'Affiliation': 'Professor, Unit of Oral and Maxillofacial Surgery, Oral Health Sciences Centre, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.04.037']
827,32510462,Effectiveness of a 3-Month Mobile Phone-Based Behavior Change Program on Active Transportation and Physical Activity in Adults: Randomized Controlled Trial.,"BACKGROUND


Active transportation (AT; ie, walking and cycling as a mode for transportation) has been associated with decreased morbidity and mortality; however, low-cost and scalable intervention programs are lacking.
OBJECTIVE


The goal of the research was to determine the effectiveness of a 3-month behavior change program delivered via a mobile phone app to promote AT (TravelVu Plus) on time spent in moderate-to-vigorous physical activity (MVPA).
METHODS


For this 2-arm parallel randomized controlled trial, we recruited a population-based sample of 254 adults from Stockholm County who were aged 20 to 65 years and had access to a smartphone. On completion of 1-week baseline measures, the 254 participants were randomized to either the control or intervention group (1:1 ratio). Both groups had access to the standard TravelVu app (Trivector AB) for monitoring their AT for 6 months. The intervention group also received a 3-month behavior change program to promote AT (TravelVu Plus app). Assessors of outcomes were blinded to group allocation. Outcomes were objectively measured MVPA at 3 (primary) and 6 months. Secondary outcomes were AT, attitudes toward AT, and health-related quality of life at 3 and 6 months.
RESULTS


No effect on MVPA was observed after 3 months (P=.29); however, at 6 months the intervention group had a greater improvement in MVPA than the controls (6.05 minutes per day [95% CI 0.36 to 11.74; P=.04]). A Bayesian analyses showed that there was a 98% probability that the intervention had any effect at 6 months, and a 63% probability that this effect was >5 minute MVPA per day.
CONCLUSIONS


No effect on MVPA immediately after the intervention period (at 3 months) was observed; however, there was a delayed effect on MVPA (6 minutes per day) at 6 months, which corresponds to approximately 30% of the weekly MVPA recommendation. Our findings suggest that a behavior change program promoting AT delivered via an app may have a relevant effect on PA.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03086837; https://clinicaltrials.gov/ct2/show/NCT03086837.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s12889-018-5658-4.",2020,"No effect on MVPA was observed after 3 months (P=.29); however, at 6 months the intervention group had a greater improvement in MVPA than the controls (6.05 minutes per day [95% CI 0.36 to 11.74; P=.04]).","['254 adults from Stockholm County who were aged 20 to 65 years and had access to a smartphone', 'Adults', '254 participants']","['3-Month Mobile Phone-Based Behavior Change Program', '3-month behavior change program to promote AT (TravelVu Plus app', 'mobile phone app to promote AT (TravelVu Plus', 'MVPA']","['MVPA', 'Active Transportation and Physical Activity', 'AT, attitudes toward AT, and health-related quality of life at 3 and 6 months']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",254.0,0.218912,"No effect on MVPA was observed after 3 months (P=.29); however, at 6 months the intervention group had a greater improvement in MVPA than the controls (6.05 minutes per day [95% CI 0.36 to 11.74; P=.04]).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ek', 'Affiliation': 'Department of Clinical Science Intervention and Technology, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Alexandrou', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping, Sweden.'}, {'ForeName': 'Emmie', 'Initials': 'E', 'LastName': 'Söderström', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping, Sweden.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Bergman', 'Affiliation': 'eHealth Institute, Department of Medicine and Optometry, Linnaeus University, Kalmar, Sweden.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Delisle Nyström', 'Affiliation': 'Department of Biosciences and Nutrition, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Direito', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Eriksson', 'Affiliation': 'Strömstad Academy, Strömstad, Sweden.'}, {'ForeName': 'Pontus', 'Initials': 'P', 'LastName': 'Henriksson', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping, Sweden.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Maddison', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Trolle Lagerros', 'Affiliation': 'Department of Medicine, Clinical Epidemiology Unit, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Bendtsen', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Löf', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping, Sweden.'}]",JMIR mHealth and uHealth,['10.2196/18531']
828,32513313,Dried fruit consumption and cardiometabolic health: a randomised crossover trial.,"Fruit intake is associated with lower risk of cardiometabolic diseases. However, effects of dried fruits on cardiometabolic health are not well researched. We investigated the effect of daily dried fruit consumption compared with a carbohydrate-rich snack on cardiometabolic disease risk factors in adults with increased cardiometabolic risk. A two-period randomised crossover trial was conducted in adults (n 55) with elevated BMI and at least one additional risk factor for cardiometabolic disease to compare the effects of consuming 3/4 cup/d mixed dried fruits (plums, figs, dates and raisins) or an energy- and carbohydrate-matched control snack for 4 weeks. The primary outcome was LDL-cholesterol; secondary outcomes included other lipids and lipoproteins, glucose and insulin, C-reactive protein, blood pressure and vascular stiffness. Linear mixed models were used for data analysis. Lipid and lipoprotein concentrations did not differ between conditions; however, dried fruit increased LDL-cholesterol (0·10 mmol/l, 95 % CI 0·01, 0·20) compared with baseline. Compared with the control, dried fruit increased mean fasting glucose (0·08 mmol/l, 95 % CI 0·005, 0·16; P = 0·038). Vascular outcomes, fasting insulin and C-reactive protein did not differ between conditions. Mean weight changes did not differ (P = 0·55) but tended to increase after both conditions (dried fruit 0·3 kg, 95 % CI -0·09, 0·65; control 0·4 kg, 95 % CI 0·01, 0·75). Thus, short-term daily consumption of a large portion of mixed dried plums, figs, dates and raisins, without structured dietary guidance, did not improve cardiometabolic risk factors, compared with carbohydrate-rich snacks, in adults with increased baseline cardiometabolic risk.",2020,"Mean weight changes did not differ (P=0.55) but tended to increase after both conditions (dried fruit: 0.3 kg, 95% CI: -0.09, 0.65; control: 0.4 kg, 95% CI: 0.01, 0.75).","['adults (n=55) with elevated BMI and at least one additional risk factor for cardiometabolic disease to compare the effects of consuming 3/4 cup', 'adults with increased cardiometabolic risk']","['dried fruits', 'daily dried fruit consumption', 'carbohydrate-rich snack', 'd mixed dried fruits (plums, figs, dates, and raisins) or a calorie- and carbohydrate-matched control snack']","['Dried fruit consumption and cardiometabolic health', 'cardiometabolic health', 'mean fasting glucose', 'Vascular outcomes, fasting insulin, and C-reactive protein', 'baseline cardiometabolic risk', 'Lipid and lipoprotein concentrations', 'Mean weight changes', 'cardiometabolic risk factors', 'low-density lipoprotein cholesterol (LDL-C); secondary outcomes included other lipids and lipoproteins, glucose and insulin, C-reactive protein, blood pressure, and vascular stiffness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0453296', 'cui_str': 'Dried fruit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0330660', 'cui_str': 'Prunus domestica'}, {'cui': 'C0349966', 'cui_str': 'Figs'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0453310', 'cui_str': 'Raisins'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0453296', 'cui_str': 'Dried fruit'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C3178781', 'cui_str': 'Vascular Stiffness'}]",,0.0916874,"Mean weight changes did not differ (P=0.55) but tended to increase after both conditions (dried fruit: 0.3 kg, 95% CI: -0.09, 0.65; control: 0.4 kg, 95% CI: 0.01, 0.75).","[{'ForeName': 'Valerie K', 'Initials': 'VK', 'LastName': 'Sullivan', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA16802, USA.'}, {'ForeName': 'Kristina S', 'Initials': 'KS', 'LastName': 'Petersen', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA16802, USA.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA16802, USA.'}]",The British journal of nutrition,['10.1017/S0007114520002007']
829,32526195,"Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial.","BACKGROUND


Baloxavir marboxil (hereafter baloxavir), a selective inhibitor of influenza cap-dependent endonuclease, was approved in 2018 in the USA and Japan for the treatment of uncomplicated influenza in otherwise healthy individuals aged 12 years and older. We aimed to study the efficacy of baloxavir in outpatients at high risk of developing influenza-associated complications.
METHODS


We did a double-blind, placebo-controlled and oseltamivir-controlled trial in outpatients aged 12 years and older in 551 sites in 17 countries and territories. Eligible patients had clinically diagnosed influenza-like illness, at least one risk factor for influenza-associated complications (eg, age older than 65 years), and a symptom duration of less than 48 h. Patients were stratified by baseline symptom score (≤14 vs ≥15), pre-existing and worsened symptoms at onset of illness compared with pre-influenza (yes or no), region (Asia, North America and Europe, or southern hemisphere), and weight (<80 kg vs ≥80 kg), and randomly assigned (1:1:1) via an interactive web-response system to either a single weight-based dose of baloxavir (40 mg for patients weighing <80 kg and 80 mg for patients weighing ≥80 kg; baloxavir group), oseltamivir 75 mg twice daily for 5 days (oseltamivir group), or matching placebo (placebo group). All patients, investigators, study personnel, and data analysts were masked to treatment assignment until database lock. The primary endpoint was time to improvement of influenza symptoms (TTIIS) in the modified intention-to-treat population, which included all patients who received at least one dose of study drug and had RT-PCR-confirmed influenza virus infection. Safety was assessed in all patients who receved at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT02949011.
FINDINGS


2184 patients were enrolled from Jan 11, 2017, to March 30, 2018, and randomly assigned to receive baloxavir (n=730), placebo (n=729), or oseltamivir (n=725). The modified intention-to-treat population included 1163 patients: 388 in the baloxavir group, 386 in the placebo group, and 389 in the oseltamivir group. 557 (48%) of 1163 patients had influenza A H3N2, 484 (42%) had influenza B, 80 (7%) had influenza A H1N1, 14 patients had a mixed infection, and 28 had infections with non-typable viruses. The median TTIIS was shorter in the baloxavir group (73·2 h [95% CI 67·2 to 85·1]) than in the placebo group (102·3 h [92·7 to 113·1]; difference 29·1 h [95% CI 14·6 to 42·8]; p<0·0001). The median TTIIS in the oseltamivir group was 81·0 h (95% CI 69·4 to 91·5), with a difference from the baloxavir group of 7·7 h (-7·9 to 22·7). Adverse events were reported in 183 (25%) of 730 patients in the baloxavir group, 216 (30%) of 727 in the placebo group, and 202 (28%) of 721 in the oseltamivir group. Serious adverse events were noted in five patients in the baloxavir group, nine patients in the placebo group, and eight patients in the oseltamivir group; one case each of hypertension and nausea in the placebo group and two cases of transaminase elevation in the oseltamivir group were considered to be treatment related. Polymerase acidic protein variants with Ile38Thr, Ile38Met, or Ile38Asn substitutions conferring reduced baloxavir susceptibility emerged in 15 (5%) of 290 baloxavir recipients assessed for amino acid substitutions in the virus.
INTERPRETATION


Single-dose baloxavir has superior efficacy to placebo and similar efficacy to oseltamivir for ameliorating influenza symptoms in high-risk outpatients. The safety of baloxavir was comparable to placebo. This study supports early therapy for patients at high risk of complications of influenza to speed clinical recovery and reduce complications.
FUNDING


Shionogi.",2020,The median TTIIS was shorter in the baloxavir group (73·2 h [95% CI 67·2 to 85·1]) than in the placebo group (102·3 h [92·7 to 113·1]; difference 29·1 h [95% CI 14·6 to 42·8]; p<0·0001).,"['outpatients at high risk of developing influenza-associated complications', '1163 patients: 388 in the baloxavir group, 386 in the placebo group, and 389 in the oseltamivir group', 'Eligible patients had clinically diagnosed influenza-like illness, at least one risk factor for influenza-associated complications (eg, age older than 65 years), and a symptom duration of less than 48 h. Patients were stratified by baseline symptom score (≤14 vs ≥15), pre-existing and worsened symptoms at onset of illness compared with pre-influenza (yes or no), region (Asia, North America and Europe, or southern hemisphere), and weight (<80 kg vs ≥80 kg', 'n=729), or oseltamivir (n=725', '14 patients had a mixed infection, and 28 had infections with non-typable viruses', 'otherwise healthy individuals aged 12 years and older', '557 (48%) of 1163 patients had influenza A H3N2, 484 (42%) had influenza B, 80 (7', 'outpatients aged 12 years and older in 551 sites in 17 countries and territories', 'high-risk outpatients', 'patients at high risk of complications of influenza to speed clinical recovery and reduce complications', 'patients who receved at least one dose of study drug', 'high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2', '2184 patients were enrolled from Jan 11, 2017, to March 30, 2018']","['placebo-controlled and oseltamivir', 'interactive web-response system to either a single weight-based dose of baloxavir', 'oseltamivir', 'baloxavir', 'oseltamivir 75 mg twice daily for 5 days (oseltamivir group), or matching placebo (placebo', 'baloxavir marboxil', 'Baloxavir marboxil (hereafter baloxavir', 'placebo']","['Safety', 'Adverse events', 'baloxavir susceptibility', 'median TTIIS', 'hypertension and nausea', 'safety of baloxavir', 'time to improvement of influenza symptoms (TTIIS', 'transaminase elevation', 'Serious adverse events']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4734224', 'cui_str': 'baloxavir'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517752', 'cui_str': '389'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0277793', 'cui_str': 'Onset of illness'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1615607', 'cui_str': 'Influenza A virus subtype H1N1'}, {'cui': 'C0580267', 'cui_str': 'H3N2'}, {'cui': 'C0276353', 'cui_str': 'Influenza due to Influenza B virus'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4734224', 'cui_str': 'baloxavir'}, {'cui': 'C1126043', 'cui_str': 'Oseltamivir 75 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4688747', 'cui_str': 'Baloxavir marboxil'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4734224', 'cui_str': 'baloxavir'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",2184.0,0.618107,The median TTIIS was shorter in the baloxavir group (73·2 h [95% CI 67·2 to 85·1]) than in the placebo group (102·3 h [92·7 to 113·1]; difference 29·1 h [95% CI 14·6 to 42·8]; p<0·0001).,"[{'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Ison', 'Affiliation': 'Divisions of Infectious Diseases and Organ Transplantation, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. Electronic address: mgison@northwestern.edu.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Portsmouth', 'Affiliation': 'Shionogi, Florham Park, NJ, USA.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yoshida', 'Affiliation': 'Shionogi, Florham Park, NJ, USA.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Shishido', 'Affiliation': 'Shionogi and Company, Osaka, Japan.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mitchener', 'Affiliation': 'Shionogi, Florham Park, NJ, USA.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tsuchiya', 'Affiliation': 'Shionogi and Company, Osaka, Japan.'}, {'ForeName': 'Takeki', 'Initials': 'T', 'LastName': 'Uehara', 'Affiliation': 'Shionogi and Company, Osaka, Japan.'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia School of Medicine, Charlottesville, VA, USA.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30004-9']
830,32534080,Photographic assessment of postsurgical facial scars epidermally sutured with rapidly absorbable polyglactin 910 or nylon: A randomized clinical trial.,"BACKGROUND


Surgeons use absorbable and nonabsorbable sutures for epidermal wound closure. No large, randomized studies have compared the effect of these suture types on facial scar appearance.
OBJECTIVE


To assess postsurgical facial scar appearance using either rapidly absorbable polyglactin 910 or nylon for epidermal closure.
METHODS


Randomized, blinded, split-scar clinical trial. A total of 105 patients with facial wounds resulting from Mohs micrographic surgery excisions were randomly assigned for epidermal closure with rapidly absorbable 5-0 polyglactin 910 (Vicryl Rapide) on one half of the repair and 5-0 nylon (Ethilon) on the other half. Two physicians (1 dermatologist and 1 plastic surgeon), unaware of the original suture location, examined photographs of each healed wound at 6 months after surgery and graded the appearance of each half of the scar using the visual analog scale, wound evaluation scale, and Stony Brook Scar Evaluation Scale.
RESULTS


At 6 months, there was no significant difference in the combined mean (standard deviation) visual analog scale scores (83.1 [14.2] and 83.0 [13.7]), Stony Brook Scar Evaluation Scale scores (4.3 [0.9] and 4.4 [0.9]), or wound evaluation scale scores (5.3 [1.1] and 5.2 [1.1]) for rapidly absorbable polyglactin 910 versus nylon (P = .72, .57, and .21, respectively).
LIMITATIONS


Single institution.
CONCLUSIONS


Both rapidly absorbable polyglactin 910 and nylon sutures placed through the epidermis resulted in an equivalent photographic appearance of facial scars at 6 months after surgery.",2020,Both rapidly-absorbable polyglactin 910 and nylon sutures placed through epidermis resulted in an equivalent photographic appearance of facial scars at six-months postoperatively.,['105 patients with facial wounds resulting from MMS excisions'],"['rapidly-absorbable polyglactin 910 or nylon', 'absorbable and non-absorbable sutures', 'epidermal closure using rapidly-absorbable 5-0 polyglactin 910 (Vicryl Rapide™) on one half of the repair, and 5-0 nylon (Ethilon™) on the other half', 'Photographic assessment of post-surgical facial scars epidermally sutured with rapidly-absorbable polyglactin 910 or nylon']","['equivalent photographic appearance of facial scars', 'visual analog scale (VAS), wound evaluation scale (WES), and Stony Brook scar evaluation scale (SBSES', 'WES scores', 'combined mean (SD) VAS scores', 'facial scar appearance']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0025706', 'cui_str': 'Methylmesilate'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0032495', 'cui_str': 'Polygalactin 910'}, {'cui': 'C0028736', 'cui_str': 'Nylon'}, {'cui': 'C0461628', 'cui_str': 'Non-absorbable suture'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0947694', 'cui_str': 'Vicryl'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205863', 'cui_str': 'Ethilon'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2229249', 'cui_str': 'Scar of face'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C2229249', 'cui_str': 'Scar of face'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",105.0,0.110754,Both rapidly-absorbable polyglactin 910 and nylon sutures placed through epidermis resulted in an equivalent photographic appearance of facial scars at six-months postoperatively.,"[{'ForeName': 'Benvon', 'Initials': 'B', 'LastName': 'Moran', 'Affiliation': ""Department of Dermatology and Skin Science, University of British Columbia, Vancouver, Canada; Division of Dermatology, Queen's University, Kingston, Ontario, Canada. Electronic address: benvon.moran@queensu.ca.""}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Humphrey', 'Affiliation': 'Department of Dermatology and Skin Science, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Seal', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Berkowitz', 'Affiliation': 'Sauder School of Business, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zloty', 'Affiliation': 'Department of Dermatology and Skin Science, University of British Columbia, Vancouver, Canada.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.06.016']
831,32540842,One Drop App With an Activity Tracker for Adults With Type 1 Diabetes: Randomized Controlled Trial.,"BACKGROUND


In 2017, mobile app support for managing diabetes was available to 64% of the global population of adults with diabetes. One Drop's digital therapeutics solution includes an evidence-based mobile app with global reach, a Bluetooth-connected glucometer, and in-app coaching from Certified Diabetes Educators. Among people with type 1 diabetes and an estimated hemoglobin A 1c  level≥7.5%, using One Drop for 3 months has been associated with an improved estimated hemoglobin A 1c  level of 22.2 mg/dL (-0.80%). However, the added value of integrated activity trackers is unknown.
OBJECTIVE


We conducted a pragmatic, remotely administered randomized controlled trial to evaluate One Drop with a new-to-market activity tracker against One Drop only on the 3-month hemoglobin A 1c  level of adults with type 1 diabetes.
METHODS


Social media advertisements and online newsletters were used to recruit adults (≥18 years old) diagnosed (≥1 year) with T1D, naïve to One Drop's full solution and the activity tracker, with a laboratory hemoglobin A 1c  level≥7%. Participants (N=99) were randomized to receive One Drop and the activity tracker or One Drop only at the start of the study. The One Drop only group received the activity tracker at the end of the study. Multiple imputation, performed separately by group, was used to correct for missing data. Analysis of covariance models, controlling for baseline hemoglobin A 1c , were used to evaluate 3-month hemoglobin A 1c  differences in intent-to-treat (ITT) and per protocol (PP) analyses.
RESULTS


The enrolled sample (N=95) had a mean age of 41 (SD 11) years, was 73% female, 88% White, diagnosed for a mean of 20 (SD 11) years, and had a mean hemoglobin A 1c  level of 8.4% (SD 1.2%); 11% of the participants did not complete follow up. Analysis of covariance assumptions were met for the ITT and PP models. In ITT analysis, participants in the One Drop and activity tracker condition had a significantly lower 3-month hemoglobin A 1c  level (mean 7.9%, SD 0.60%, 95% CI 7.8-8.2) than that of the participants in the One Drop only condition (mean 8.4%, SD 0.62%, 95% CI 8.2-8.5). In PP analysis, participants in the One Drop and activity tracker condition also had a significantly lower 3-month hemoglobin A 1c  level (mean 7.9%, SD 0.59%, 95% CI 7.7-8.1) than that of participants in the One Drop only condition (mean 8.2%, SD 0.58%, 95% CI 8.0-8.4).
CONCLUSIONS


Participants exposed to One Drop and the activity tracker for the 3-month study period had a significantly lower 3-month hemoglobin A 1c  level compared to that of participants exposed to One Drop only during the same timeframe. One Drop and a tracker may work better together than alone in helping people with type 1 diabetes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03459573; https://clinicaltrials.gov/ct2/show/NCT03459573.",2020,"In ITT, participants with OD + tracker had a significantly lower three-month A1c (7.9% [95% CI 7.8 - 8.2]  .60%) than did participants with OD only (8.4% [95% CI 8.2 - 8.5]  .62%).","['Participants (N = 99', ""adults with T1D.\nMETHODS\n\n\nSocial media advertisements and online newsletters recruited adults (≥ 18 years old) diagnosed (≥ 1 year) with T1D, naïve to OD's full solution and the activity tracker with lab A1c ≥ 7"", 'The enrolled sample (n = 95) was 41 ± 11 years old, 73% female, 88% White, diagnosed for 20 ± 11 years with a mean A1c of 8.4% ± 1.2', 'Adults with Type 1 Diabetes']","['OD plus activity tracker', 'new-to-market activity tracker', 'Activity Tracker']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1318228', 'cui_str': 'Market'}]",[],99.0,0.0789327,"In ITT, participants with OD + tracker had a significantly lower three-month A1c (7.9% [95% CI 7.8 - 8.2]  .60%) than did participants with OD only (8.4% [95% CI 8.2 - 8.5]  .62%).","[{'ForeName': 'Chandra Y', 'Initials': 'CY', 'LastName': 'Osborn', 'Affiliation': 'Informed Data Systems Inc, New York, NY, United States.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Hirsch', 'Affiliation': 'Informed Data Systems Inc, New York, NY, United States.'}, {'ForeName': 'Lindsay E', 'Initials': 'LE', 'LastName': 'Sears', 'Affiliation': 'Informed Data Systems Inc, New York, NY, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Heyman', 'Affiliation': 'Informed Data Systems Inc, New York, NY, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Raymond', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Huddleston', 'Affiliation': 'Informed Data Systems Inc, New York, NY, United States.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Dachis', 'Affiliation': 'Informed Data Systems Inc, New York, NY, United States.'}]",JMIR mHealth and uHealth,['10.2196/16745']
832,32534578,"Rationale and design of an investigator-initiated, multicenter, prospective open-label, randomized trial to evaluate the effect of ipragliflozin on endothelial dysfunction in type 2 diabetes and chronic kidney disease: the PROCEED trial.","BACKGROUND


Type 2 diabetes (T2D) is associated with renal impairment and vascular endothelial dysfunction. Therefore, this pathological connection is an important therapeutic target. Recent cardiovascular and renal outcome trials demonstrated that sodium glucose cotransporter 2 inhibitors (SGLT2is) consistently reduced the risks of cardiovascular and renal events and mortality in patients with T2D and various other background risks including chronic kidney disease (CKD). However, the precise mechanisms by which SGLT2is accords these therapeutic benefits remain uncertain. It is also unknown whether these SGLT2is-associated benefits are associated with the amelioration of endothelial dysfunction in patients with T2D and CKD.
METHODS


The PROCEED trial is an investigator-initiated, prospective, multicenter, open-label, randomized-controlled trial. The target sample size is 110 subjects. After they furnish informed consent and their endothelial dysfunction is confirmed from their decreased reactive hyperemia indices (RHI), eligible participants with T2D (HbA1c, 6.0-9.0%) and established CKD (30 mL/min/1.73 m 2  ≤ estimated glomerular filtration ratio [eGFR] < 60 and/or ≥ urine albumin-to-creatinine ratio 30 mg/g Cr) will be randomized (1:1) to receive either 50 mg ipragliflozin daily or continuation of background treatment (non-SGLT2i). The primary endpoint is the change in RHI from baseline after 24 weeks. To compare the treatment effects between groups, the baseline-adjusted means and their 95% confidence intervals will be estimated by analysis of covariance adjusted for HbA1c (< 7.0% or ≥ 7.0%), age (< 70 y or ≥ 70 y), RHI (< 1.67 or ≥ 1.67), eGFR (< 45 mL/min/1.73 m 2  or ≥ 45 mL/min/1.73 m 2 ), and smoking status. Prespecified responder analyses will be also conducted to determine the proportions of patients with clinically meaningful changes in RHI at 24 weeks.
DISCUSSION


PROCEED is the first trial to examine the effects of ipragliflozin on endothelial dysfunction in patients with T2D and CKD. This ongoing trial will establish whether endothelial dysfunction is a therapeutic target of SGLT2is in this population. It will also provide deep insights into the potential mechanisms by which SGLT2is reduced the risks of cardiovascular and renal events in recent outcome trials. Trial registration Unique Trial Number, jRCTs071190054 (https://jrct.niph.go.jp/en-latest-detail/jRCTs071190054).",2020,"After they furnish informed consent and their endothelial dysfunction is confirmed from their decreased reactive hyperemia indices (RHI), eligible participants with T2D (HbA1c, 6.0-9.0%) and established CKD (30 mL","['110 subjects', 'patients with T2D and various other background risks including chronic kidney disease (CKD', 'type 2 diabetes and chronic kidney disease', 'patients with T2D and CKD']","['ipragliflozin daily or continuation of background treatment (non-SGLT2i', 'sodium glucose cotransporter 2 inhibitors (SGLT2is', 'ipragliflozin']","['glomerular filtration ratio [eGFR', 'change in RHI', 'and/or\u2009≥\u2009urine albumin-to-creatinine ratio 30', 'reactive hyperemia indices', 'risks of cardiovascular and renal events and mortality', 'endothelial dysfunction']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C3492889', 'cui_str': 'ipragliflozin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0232809', 'cui_str': 'Glomerular filtration'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}]",,0.113996,"After they furnish informed consent and their endothelial dysfunction is confirmed from their decreased reactive hyperemia indices (RHI), eligible participants with T2D (HbA1c, 6.0-9.0%) and established CKD (30 mL","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan. tanakaa2@cc.saga-u.ac.jp.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Shimabukuro', 'Affiliation': 'Department of Diabetes, Endocrinology, and Metabolism, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Sugimoto', 'Affiliation': 'Diabetes Center, Ohta Nishinouchi Hospital, Koriyama, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kurozumi', 'Affiliation': 'Wakamatsu Hospital of the University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Torimoto', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Hirai', 'Affiliation': 'Department of Diabetes, Endocrinology, and Metabolism, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan. node@cc.saga-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular diabetology,['10.1186/s12933-020-01065-w']
833,32542748,"Prospective, randomized trial of treatment for mild ulnar neuropathy at the elbow.",,2020,,['mild ulnar neuropathy at the elbow'],[],[],"[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0154743', 'cui_str': 'Ulnar neuropathy'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}]",[],[],,0.0211104,,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Podnar', 'Affiliation': 'Institute of Clinical Neurophysiology, Division of Neurology, University Medical Center, Ljubljana, Slovenia.'}]",Muscle & nerve,['10.1002/mus.27005']
834,32544297,Long-term safety and efficacy of N8-GP in previously treated adults and adolescents with hemophilia A: Final results from pathfinder2.,"BACKGROUND


N8-GP (turoctocog alfa pegol; Esperoct ®  , Novo Nordisk A/S, Bagsvaerd, Denmark) is a glycoPEGylated human recombinant factor VIII with a half-life of ~1.6-fold of standard FVIII products. pathfinder2 (NCT01480180) was a multi-national, open-label trial of N8-GP in previously treated adolescent and adult patients with severe hemophilia A.
OBJECTIVE


We report end-of-trial efficacy and safety of N8-GP from pathfinder2.
METHODS


pathfinder2 main phase and extension phase part 1 results have been previously reported. During extension phase part 2, patients could switch from N8-GP prophylaxis 50 IU/kg every fourth day (Q4D) or 75 IU/kg once weekly (Q7D), depending on bleeding status. Extension phase part 2 collected long-term safety and efficacy data for all regimens until trial end (first patient in main phase, 30 January 2012; trial end, 10 December 2018).
RESULTS


Overall, 186 patients were exposed to N8-GP for up to 6.6 years (median 5.4 years). The estimated annualized bleeding rate (ABR) was 2.14 (median 0.84) for the Q4D prophylaxis arm and 1.31 (median 1.67) for the Q7D prophylaxis arm. Nearly 30% of patients experienced zero bleeds throughout the entire duration of the trial, the hemostatic response was 83.2% across all treatment arms, and patient-reported outcomes were maintained or slightly improved. No safety concerns were detected.
CONCLUSION


Data from the completed pathfinder2 trial, one of the largest and longest-running clinical trials to investigate treatment of severe hemophilia A, demonstrate the efficacy and safety of N8-GP in previously treated adolescent and adult patients.",2020,The estimated annualized bleeding rate (ABR) was 2.14 (median 0.84) for the Q4D prophylaxis arm and 1.31 (median 1.67) for the Q7D prophylaxis arm.,"['previously treated adults and adolescents with hemophilia A', 'previously treated adolescent and adult patients', '186 patients were exposed to N8-GP for up to 6.6\xa0years (median 5.4\xa0years', 'previously treated adolescent and adult patients with severe hemophilia A']",['N8-GP'],"['hemostatic response', 'annualized bleeding rate (ABR']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}]",[],"[{'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",186.0,0.0938106,The estimated annualized bleeding rate (ABR) was 2.14 (median 0.84) for the Q4D prophylaxis arm and 1.31 (median 1.67) for the Q7D prophylaxis arm.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Giangrande', 'Affiliation': 'Department of Clinical and Laboratory Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Faraizah', 'Initials': 'F', 'LastName': 'Abdul Karim', 'Affiliation': 'National Blood Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Laszlo', 'Initials': 'L', 'LastName': 'Nemes', 'Affiliation': 'National Hemophilia Center and Hemostasis Department, Medical Center of the Hungarian Defence Forces, Budapest, Hungary.'}, {'ForeName': 'Chur Woo', 'Initials': 'CW', 'LastName': 'You', 'Affiliation': 'Pediatric Department, Eulji University Hospital, Daejeon, Korea.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Landorph', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Milan S', 'Initials': 'MS', 'LastName': 'Geybels', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Curry', 'Affiliation': 'Oxford Haemophilia and Thrombosis Centre and Oxford National Institute for Health Research Biomedical Research Centre, Churchill Hospital, Oxford, UK.'}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.14959']
835,32556518,Effect of high-dose vitamin D supplementation on peripheral arterial calcification: secondary analysis of a randomized controlled trial.,"Although high-dose vitamin D supplementation is common, effects on arterial calcification remain unexplored. Tibial artery calcification was identified and quantified over 3 years in participants randomized to 400, 4000, or 10,000 IU vitamin D 3  daily. High-dose vitamin D supplementation did not affect the development or progression of arterial calcification.
INTRODUCTION


To determine whether vitamin D supplementation has a dose-dependent effect on development and progression of arterial calcification.
METHODS


This was a secondary analysis of the Calgary Vitamin D Study, a 3-year, double-blind, randomized controlled trial conducted at a single-center in Calgary, Canada. Participants were community-dwelling adults aged 55-70 years with serum 25-hydroxyvitamin D 30-125 nmol/L. Participants were randomized 1:1:1 to receive vitamin D 3  400, 4000, or 10,000 IU/day for 3 years. Tibial artery calcification was identified and quantified (in milligrams of hydroxyapatite, mgHA) using high-resolution peripheral quantitative computed tomography (HR-pQCT) at baseline and 6, 12, 24, and 36 months. Changes in calcification over time and treatment group interaction were evaluated using a constrained linear mixed effects model.
RESULTS


Of 311 randomized participants, 302 (400: 105, 4000: 96, 10,000: 101) were eligible for analysis of arterial calcification (54% male, mean (SD) age 62 (4) years, mean (SD) 25-hydroxyvitamin D 78.9 (19.9) nmol/L). At baseline, 85 (28%) had tibial artery calcification, and mean (95% CI) calcification quantity was 2.8 mgHA (95% CI 1.7-3.9). In these 85 participants, calcification quantity increased linearly by 0.020 mgHA/month (95% CI 0.012-0.029) throughout the study, with no evidence of a treatment-group effect (p = 0.645 for interaction). No participants developed new arterial calcifications during the study.
CONCLUSIONS


In this population of community-dwelling adults who were vitamin D replete at baseline, supplementation with vitamin D 400, 4000, or 10,000 IU/day did not have differential effects on the development or progression of arterial calcification over 3 years.
TRIAL REGISTRATION


clinicaltrials.gov (NCT01900860).",2020,"In these 85 participants, calcification quantity increased linearly by 0.020 mgHA/month (95% CI 0.012-0.029) throughout the study, with no evidence of a treatment-group effect (p = 0.645 for interaction).","['Of 311 randomized participants, 302 (400: 105', '4000: 96, 10,000: 101) were eligible for analysis of arterial calcification (54% male, mean (SD) age 62 (4) years, mean (SD) 25-hydroxyvitamin', 'Participants were community-dwelling adults aged 55-70\xa0years with serum 25-hydroxyvitamin D 30-125\xa0nmol/L. Participants']","['high-dose vitamin D supplementation', 'vitamin D', 'vitamin D supplementation', 'High-dose vitamin D supplementation']","['Tibial artery calcification', 'calcification quantity', 'development or progression of arterial calcification', 'peripheral arterial calcification', 'new arterial calcifications', 'tibial artery calcification']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1168153', 'cui_str': 'Arterial calcification'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0085427', 'cui_str': 'Tibial artery'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1168153', 'cui_str': 'Arterial calcification'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205314', 'cui_str': 'New'}]",101.0,0.772187,"In these 85 participants, calcification quantity increased linearly by 0.020 mgHA/month (95% CI 0.012-0.029) throughout the study, with no evidence of a treatment-group effect (p = 0.645 for interaction).","[{'ForeName': 'E O', 'Initials': 'EO', 'LastName': 'Billington', 'Affiliation': 'McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, Canada. emma.billington@ahs.ca.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Burt', 'Affiliation': 'McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Plett', 'Affiliation': 'McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Rose', 'Affiliation': 'Research Facilitation, Alberta Health Services, Calgary, Canada.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Boyd', 'Affiliation': 'McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Hanley', 'Affiliation': 'McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05500-2']
836,32578850,A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes: the DAPA-LVH trial.,"AIM


We tested the hypothesis that dapagliflozin may regress left ventricular hypertrophy (LVH) in people with type 2 diabetes (T2D).
METHODS AND RESULTS


We randomly assigned 66 people (mean age 67 ± 7 years, 38 males) with T2D, LVH, and controlled blood pressure (BP) to receive dapagliflozin 10 mg once daily or placebo for 12 months. Primary endpoint was change in absolute left ventricular mass (LVM), assessed by cardiac magnetic resonance imaging. In the intention-to-treat analysis, dapagliflozin significantly reduced LVM compared with placebo with an absolute mean change of -2.82g [95% confidence interval (CI): -5.13 to -0.51, P = 0.018]. Additional sensitivity analysis adjusting for baseline LVM, baseline BP, weight, and systolic BP change showed the LVM change to remain statistically significant (mean change -2.92g; 95% CI: -5.45 to -0.38, P = 0.025). Dapagliflozin significantly reduced pre-specified secondary endpoints including ambulatory 24-h systolic BP (P = 0.012), nocturnal systolic BP (P = 0.017), body weight (P < 0.001), visceral adipose tissue (VAT) (P < 0.001), subcutaneous adipose tissue (SCAT) (P = 0.001), insulin resistance, Homeostatic Model Assessment of Insulin Resistance (P = 0.017), and high-sensitivity C-reactive protein (hsCRP) (P = 0.049).
CONCLUSION


Dapagliflozin treatment significantly reduced LVM in people with T2D and LVH. This reduction in LVM was accompanied by reductions in systolic BP, body weight, visceral and SCAT, insulin resistance, and hsCRP. The regression of LVM suggests dapagliflozin can initiate reverse remodelling and changes in left ventricular structure that may partly contribute to the cardio-protective effects of dapagliflozin.
CLINICALTRIALS.GOV IDENTIFIER


NCT02956811.",2020,"Dapagliflozin significantly reduced pre-specified secondary endpoints including ambulatory 24-h systolic BP (P = 0.012), nocturnal systolic BP (P = 0.017), body weight (P < 0.001), visceral adipose tissue (VAT) (P < 0.001), subcutaneous adipose tissue (SCAT) (P = 0.001), insulin resistance, Homeostatic Model Assessment of Insulin Resistance (P = 0.017), and high-sensitivity C-reactive protein (hsCRP) (P = 0.049).
","['66 people (mean age 67 ± 7 years, 38 males) with T2D, LVH, and controlled blood pressure (BP) to receive', 'people with type 2 diabetes (T2D', 'people with type two diabetes']","['placebo', 'Dapagliflozin', 'dapagliflozin', 'dapagliflozin 10 mg once daily or placebo']","['ambulatory 24-h systolic BP', 'subcutaneous adipose tissue (SCAT', 'systolic BP, body weight, visceral and SCAT, insulin resistance, and hsCRP', 'body weight', 'LVM', 'baseline LVM, baseline BP, weight, and systolic BP change', 'left ventricular hypertrophy (LVH', 'absolute left ventricular mass (LVM), assessed by cardiac magnetic resonance imaging', 'nocturnal systolic BP', 'left ventricular hypertrophy', 'visceral adipose tissue (VAT', 'insulin resistance, Homeostatic Model Assessment of Insulin Resistance', 'high-sensitivity C-reactive protein (hsCRP']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0270500', 'cui_str': 'Coprophilia'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0042427', 'cui_str': 'Vatican City'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",66.0,0.50898,"Dapagliflozin significantly reduced pre-specified secondary endpoints including ambulatory 24-h systolic BP (P = 0.012), nocturnal systolic BP (P = 0.017), body weight (P < 0.001), visceral adipose tissue (VAT) (P < 0.001), subcutaneous adipose tissue (SCAT) (P = 0.001), insulin resistance, Homeostatic Model Assessment of Insulin Resistance (P = 0.017), and high-sensitivity C-reactive protein (hsCRP) (P = 0.049).
","[{'ForeName': 'Alexander J M', 'Initials': 'AJM', 'LastName': 'Brown', 'Affiliation': 'Division of Molecular & Clinical Medicine, School of Medicine, Ninewells Hospital & Medical School, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gandy', 'Affiliation': 'Department of Medical Physics, Ninewells Hospital & Medical School, Dundee DD1 9SY, UK.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'McCrimmon', 'Affiliation': 'Division of Molecular & Clinical Medicine, School of Medicine, Ninewells Hospital & Medical School, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'John Graeme', 'Initials': 'JG', 'LastName': 'Houston', 'Affiliation': 'Department of Radiology, Ninewells Hospital & Medical School, Dundee DD1 9SY, UK.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Struthers', 'Affiliation': 'Division of Molecular & Clinical Medicine, School of Medicine, Ninewells Hospital & Medical School, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Chim C', 'Initials': 'CC', 'LastName': 'Lang', 'Affiliation': 'Division of Molecular & Clinical Medicine, School of Medicine, Ninewells Hospital & Medical School, University of Dundee, Dundee DD1 9SY, UK.'}]",European heart journal,['10.1093/eurheartj/ehaa419']
837,32442195,Antibody and cellular responses to HIV vaccine regimens with DNA plasmid as compared with ALVAC priming: An analysis of two randomized controlled trials.,"BACKGROUND


DNA plasmids promise a pragmatic alternative to viral vectors for prime-boost HIV-1 vaccines. We evaluated DNA plasmid versus canarypox virus (ALVAC) primes in 2 randomized, double-blind, placebo-controlled trials in southern Africa with harmonized trial designs. HIV Vaccine Trials Network (HVTN) 111 tested DNA plasmid prime by needle or needleless injection device (Biojector) and DNA plasmid plus gp120 protein plus MF59 adjuvant boost. HVTN 100 tested ALVAC prime and ALVAC plus gp120 protein plus MF59 adjuvant boost (same protein/adjuvant as HVTN 111) by needle.
METHODS AND FINDINGS


The primary endpoints for this analysis were binding antibody (bAb) responses to HIV antigens (gp120 from strains ZM96, 1086, and TV1; variable 1 and 2 [V1V2] regions of gp120 from strains TV1, 1086, and B.CaseA, as 1086 V1V2 and B.CaseA were correlates of risk in the RV144 efficacy trial), neutralizing antibody (nAb) responses to pseudoviruses TV1c8.2 and MW925.26, and cellular responses to vaccine-matched antigens (envelope [Env] from strains ZM96, 1086, and TV1; and Gag from strains LAI and ZM96) at month 6.5, two weeks after the fourth vaccination. Per-protocol cohorts included vaccine recipients from HVTN 100 (n = 186, 60% male, median age 23 years) enrolled between February 9, 2015, and May 26, 2015 and from HVTN 111 (n = 56, 48% male, median age 24 years) enrolled between June 21, 2016, and July 13, 2017. IgG bAb response rates were 100% to 3 Env gp120 antigens in both trials. Response rates to V1V2 were lower and similar in both trials except to vaccine-matched 1086 V1V2, with rates significantly higher for the DNA-primed regimen than the ALVAC-primed regimen: 96.6% versus 72.7% (difference = 23.9%, 95% CI 15.6%-32.2%, p < 0.001). Among positive responders, bAb net mean fluorescence intensity (MFI) was significantly higher with the DNA-primed regimen than ALVAC-primed for 1086 V1V2 (geometric mean [GM] 2,833.3 versus 1,200.9; ratio = 2.36, 95% CI 1.42-3.92, p < 0.001) and B.CaseA V1V2 (GM 2314.0 versus 744.6, ratio = 3.11, 95% CI 1.51-6.38, p = 0.002). nAb response rates were >98% in both trials, with significantly higher 50% inhibitory dilution (ID50) among DNA-primed positive responders (n = 53) versus ALVAC-primed (n = 182) to tier 1A MW965.26 (GM 577.7 versus 265.7, ratio = 2.17, 95% CI 1.67-2.83, p < 0.001) and to TV1c8.2 (GM 187.3 versus 100.4, ratio = 1.87, 95% CI 1.48-2.35, p < 0.001). CD4+ T-cell response rates were significantly higher with DNA plasmid prime via Biojector than ALVAC prime (91.4% versus 52.8%, difference = 38.6%, 95% CI 20.5%-56.6%, p < 0.001 for ZM96.C; 88.0% versus 43.1%, difference = 44.9%, 95% CI 26.7%-63.1%, p < 0.001 for 1086.C; 55.5% versus 2.2%, difference = 53.3%, 95% CI 23.9%-82.7%, p < 0.001 for Gag LAI/ZM96). The study's main limitations include the nonrandomized comparison of vaccines from 2 different trials, the lack of data on immune responses to other non-vaccine-matched antigens, and the uncertain clinical significance of the observed immunological effects.
CONCLUSIONS


In this study, we found that further investigation of DNA/protein regimens is warranted given enhanced immunogenicity to the V1V2 correlates of decreased HIV-1 acquisition risk identified in RV144, the only HIV vaccine trial to date to show any efficacy.",2020,"Response rates to V1V2 were lower and similar in both trials except to vaccine-matched 1086 V1V2, with rates significantly higher for the DNA-primed regimen than the ALVAC-primed regimen: 96.6% versus 72.7% (difference = 23.9%, 95% CI 15.6%-32.2%, p < 0.001).","['Per-protocol cohorts included vaccine recipients from HVTN 100', 'southern Africa with harmonized trial designs', 'n = 186, 60% male, median age 23 years) enrolled between February 9, 2015, and May 26, 2015 and from HVTN 111 (n = 56, 48% male, median age 24 years) enrolled between June 21, 2016, and July 13, 2017']","['placebo', 'ALVAC priming', 'DNA plasmid versus canarypox virus (ALVAC']","['IgG bAb response rates', 'nAb response rates', 'Response rates to V1V2', 'binding antibody (bAb) responses to HIV antigens (gp120 from strains ZM96, 1086, and TV1; variable 1 and 2 [V1V2] regions of gp120 from strains TV1, 1086, and B.CaseA, as 1086 V1V2 and B.CaseA were correlates of risk in the RV144 efficacy trial), neutralizing antibody (nAb) responses to pseudoviruses TV1c8.2 and MW925.26, and cellular responses to vaccine-matched antigens (envelope [Env] from strains ZM96, 1086, and TV1; and Gag from strains LAI and ZM96', 'bAb net mean fluorescence intensity (MFI', 'CD4+ T-cell response rates']","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001746', 'cui_str': 'Southern Africa'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0211671', 'cui_str': 'ALVAC vaccine'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0032136', 'cui_str': 'Plasmid'}, {'cui': 'C0282472', 'cui_str': 'Canarypox virus'}]","[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0019686', 'cui_str': 'AIDS Antigens'}, {'cui': 'C0019691', 'cui_str': 'env Protein gp120, HIV'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0443021', 'cui_str': 'Lai'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",,0.585483,"Response rates to V1V2 were lower and similar in both trials except to vaccine-matched 1086 V1V2, with rates significantly higher for the DNA-primed regimen than the ALVAC-primed regimen: 96.6% versus 72.7% (difference = 23.9%, 95% CI 15.6%-32.2%, p < 0.001).","[{'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Moodie', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': ""Division of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, United States of America.""}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Laher', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Maganga', 'Affiliation': 'NIMR-Mbeya Medical Research Center, Mbeya, Tanzania.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Herce', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Naidoo', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'UNC Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Innes', 'Affiliation': 'Aurum Institute, Klerksdorp, South Africa.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Grunenberg', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Mann', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Allan C', 'Initials': 'AC', 'LastName': 'deCamp', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Maurine D', 'Initials': 'MD', 'LastName': 'Miner', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Yates', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Heptinstall', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Nonhlanhla N', 'Initials': 'NN', 'LastName': 'Mkhize', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'One', 'Initials': 'O', 'LastName': 'Dintwe', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Frahm', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Kristen W', 'Initials': 'KW', 'LastName': 'Cohen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland United States of America.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Hutter', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland United States of America.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Wagner', 'Affiliation': 'Institute of Medical Microbiology and Hygiene, University of Regensberg, Regensberg, Germany.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'Swiss Vaccine Research Institute, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Morris', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Andersen-Nissen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Glenda E', 'Initials': 'GE', 'LastName': 'Gray', 'Affiliation': 'South African Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gilbert', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003117']
838,32444250,Variation of faecal calprotectin level within the first three months after bowel resection is predictive of endoscopic postoperative recurrence in Crohn's disease.,"BACKGROUND


Early prediction of postoperative recurrence (POR) remains a major concern in Crohn's disease (CD).
AIMS


To assess serial faecal calprotectin (Fcal) monitoring within the first three months to predict CD endoscopic POR.
METHODS


In a multicenter randomized controlled trial, CD patients received azathioprine 2.5 mg/kg/day with oral curcumin (3 g/day) or placebo. Fcal was measured at baseline, one month (M1) and M3. Endoscopic POR at M6 was defined as Rutgeerts' index ≥ i2b (central reading).
RESULTS


Among the 48 patients included, there was no significant difference of median Fcal levels at baseline (p = 0.15), M1 (p = 0.44) and M3 (p = 0.28) between patients with or without endoscopic POR at M6. Fcal kinetics during the first 3 months after surgery was significantly different between the patients with or without POR at M6 (p = 0.021). The median variation between Fcal level at baseline and M3 (ΔFcal M3-M0) was significantly higher in patients with endoscopic POR compared to those without POR (p = 0.01). ΔFcal M3-M0 >+10% demonstrated the best performances to predict endoscopic POR at M6 (AUC=0.73, sensitivity=64.7%[41.1-82.7], specificity=87.5%[68.0-96.3], negative predictive value=77.8%[57.5-91.4] and positive predictive value=78.6%[49.2-95.3]).
CONCLUSION


Fcal variation within the first three months after ileocolonic resection is a promising predictor of early endoscopic POR in CD patients.",2020,Fcal kinetics during the first 3 months after surgery was significantly different between the patients with or without POR at M6 (p = 0.021).,"[""Crohn's disease (CD"", ""Crohn's disease"", 'CD patients']","['azathioprine 2.5\u202fmg/kg/day with oral curcumin', 'ileocolonic resection', 'placebo']","['faecal calprotectin level', 'median variation between Fcal level at baseline and M3 (ΔFcal M3-M0', 'Fcal kinetics', 'serial faecal calprotectin (Fcal) monitoring', 'Endoscopic POR', 'Fcal', 'median Fcal levels']","[{'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",48.0,0.135478,Fcal kinetics during the first 3 months after surgery was significantly different between the patients with or without POR at M6 (p = 0.021).,"[{'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Boube', 'Affiliation': ""Université Clermont Auvergne, Inserm, 3iHP, CHU Clermont-Ferrand, Service d'Hépato-Gastro Entérologie, Clermont-Ferrand, France; Université Clermont Auvergne, Inserm U1071, M2iSH, USC-INRA 2018, F-63000 Clermont-Ferrand, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Laharie', 'Affiliation': 'Gastroenterology Department, University Hospital, Bordeaux, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Nancey', 'Affiliation': 'Hospices Civils de Lyon, Lyon-Sud hospital, Gastroenterology, Pierre Benite, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Hebuterne', 'Affiliation': 'Department of Gastroenterology and Clinical Nutrition, CHU of Nice and University of Nice Sophia-Antipolis, Nice, France.'}, {'ForeName': 'Mathurin', 'Initials': 'M', 'LastName': 'Fumery', 'Affiliation': 'Gastroenterology Department, University Hospital, Amiens, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Pariente', 'Affiliation': 'Gastroenterology Department, University Hospital, Lille, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Roblin', 'Affiliation': 'Gastroenterology Department, University Hospital, Saint-Etienne, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'Department of Gastroenterology, CHU Nancy Brabois, Vandoeuvre les Nancy, France.'}, {'ForeName': 'Régine', 'Initials': 'R', 'LastName': 'Minet-Quinard', 'Affiliation': 'CHU Clermont-Ferrand, Laboratoire de Biochimie, Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'CHU Clermont-Ferrand, DRCI, Unité de Biostatistiques, Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Bommelaer', 'Affiliation': ""Université Clermont Auvergne, Inserm, 3iHP, CHU Clermont-Ferrand, Service d'Hépato-Gastro Entérologie, Clermont-Ferrand, France; Université Clermont Auvergne, Inserm U1071, M2iSH, USC-INRA 2018, F-63000 Clermont-Ferrand, France.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Buisson', 'Affiliation': ""Université Clermont Auvergne, Inserm, 3iHP, CHU Clermont-Ferrand, Service d'Hépato-Gastro Entérologie, Clermont-Ferrand, France; Université Clermont Auvergne, Inserm U1071, M2iSH, USC-INRA 2018, F-63000 Clermont-Ferrand, France. Electronic address: a_buisson@hotmail.fr.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2020.03.020']
839,32445184,Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program.,"INTRODUCTION


Etrolizumab is a next-generation anti-integrin with dual action that targets two pathways of inflammation in the gut. A robust phase 3 clinical program in ulcerative colitis (UC) and Crohn's disease is ongoing and will evaluate the efficacy and safety of etrolizumab in well-defined patient populations in rigorous trials that include direct head-to-head comparisons against approved anti-tumor necrosis factor alpha agents (anti-TNF). The etrolizumab phase 3 clinical program consists of six randomized controlled trials (RCTs; UC: HIBISCUS I and II, GARDENIA, LAUREL, HICKORY; Crohn's disease: BERGAMOT) and two open-label extension trials (OLEs; UC: COTTONWOOD; Crohn's disease: JUNIPER) evaluating patients with moderately to severely active UC or Crohn's disease.
METHODS


In the UC RCTs, patients are randomly assigned according to each protocol to receive etrolizumab, adalimumab, infliximab, or placebo. In BERGAMOT, patients are randomly assigned to receive etrolizumab 105 mg, etrolizumab 210 mg, or placebo. The primary outcomes for the UC RCTs are Mayo Clinic score-based clinical response, remission, and clinical remission; for BERGAMOT, the co-primary outcomes are clinical remission (based on abdominal pain and stool frequency) and endoscopic improvement (based on the Simple Endoscopic Score for Crohn's disease). The OLEs will primarily assess long-term efficacy and safety. Secondary and exploratory endpoints include endoscopy, histology, quality of life, and biomarkers at various timepoints.
DISCUSSION


The etrolizumab phase 3 clinical program is the largest and most comprehensive in inflammatory bowel disease, enrolling more than 3000 patients. The program explores both induction and maintenance regimens. HIBISCUS I and II and GARDENIA are among the first head-to-head trials in UC against an anti-TNF and are the first registrational trials making that comparison. This program will also help address unanswered clinical questions on evaluation of treatment effects and treatment selection across a range of patients with varying treatment histories using an extensive repository of patient samples and data.
TRIAL REGISTRATION


ClinicalTrials.gov: HIBISCUS I (NCT02163759), HIBISCUS II (NCT02171429), GARDENIA (NCT02136069), LAUREL (NCT02165215), HICKORY (NCT02100696), COTTONWOOD (NCT02118584), BERGAMOT (NCT02394028), JUNIPER (NCT02403323).",2020,HIBISCUS ,"['3000 patients', ""Ulcerative Colitis and Crohn's Disease"", ""patients with moderately to severely active UC or Crohn's disease""]","['Etrolizumab', 'etrolizumab, adalimumab, infliximab, or placebo', 'etrolizumab 105\xa0mg, etrolizumab 210\xa0mg, or placebo', 'etrolizumab']","[""UC RCTs are Mayo Clinic score-based clinical response, remission, and clinical remission; for BERGAMOT, the co-primary outcomes are clinical remission (based on abdominal pain and stool frequency) and endoscopic improvement (based on the Simple Endoscopic Score for Crohn's disease"", 'endoscopy, histology, quality of life, and biomarkers at various timepoints']","[{'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3177463', 'cui_str': 'rhuMAb Beta7'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C3715207', 'cui_str': 'Bergamot orange extract'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.181287,HIBISCUS ,"[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Severine', 'Initials': 'S', 'LastName': 'Vermeire', 'Affiliation': 'University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Tyrrell', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Azra', 'Initials': 'A', 'LastName': 'Hassanali', 'Affiliation': 'F. Hoffmann-La Roche AG, Global Product Development Medical Affairs, 4070, Basel, Switzerland.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Lacey', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Tole', 'Affiliation': 'F. Hoffmann-La Roche AG, Global Product Development Medical Affairs, 4070, Basel, Switzerland.'}, {'ForeName': 'Amanda R', 'Initials': 'AR', 'LastName': 'Tatro', 'Affiliation': 'F. Hoffmann-La Roche AG, Global Product Development Medical Affairs, 4070, Basel, Switzerland. amanda.tatro@roche.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-020-01366-2']
840,32449414,Eye Care Utilization in A Community-oriented Mobile Screening Programme for Improving Eye Health in Iran: A Cluster Randomized Trial.,"PURPOSE


To evaluate the effect of a mobile-based screening programme on eye care utilization in Iran.
METHOD


In this cluster randomized community trial, a representative sample of residents aged≥50 years from urban and rural areas in four districts in Tehran province were enrolled. The clusters were randomly assigned to one of the three parallel arms; the mHealth arm with digital data collection, vision screening test and retina evaluation using an integrated mobile application, the conventional arm with manual data collection and screening tests using Snellen chart and Fundus photography at the local primary healthcare facility, and the control arm with manual data collection without screening tests. The main outcome measure was eye care utilization which was defined as at least one visit to an optometrist or ophthalmologist.
RESULTS


Of 3312 eligible individuals, 2520 (76.1%) participated. In the first 3 months after the screening programme, eye care utilization was higher among those who were referred by the mHealth method (35.6% 95%CI: 31.1-40.4%) compared to those referred by the conventional method (32.7%, 95%CI: 27.5-38.2%) and to those observed in the control arm (4.5%, 95%CI: 3.2-6.0). Eye care utilization improved (OR = 1.5, 95%CI: 1.2-1.9) among the referred people after the screening programme compared to the utilization before this programme; however, this improvement was significantly higher in the mHealth method (OR: 1.7, 95%CI: 1.2-2.4) compared to the conventional method (OR: 1.2, 95%CI: 0.8-1.8).
CONCLUSION AND RELEVANCE


The mobile-based screening programme can significantly improve eye care utilization at the community level.",2020,"Eye care utilization improved (OR = 1.5, 95%CI: 1.2-1.9) among the referred people after the screening programme compared to the utilization before this programme; however, this improvement was significantly higher in the mHealth method (OR: 1.7, 95%CI: 1.2-2.4) compared to the conventional method (OR: 1.2, 95%CI: 0.8-1.8).
","['Iran', 'Of 3312 eligible individuals, 2520 (76.1%) participated', 'representative sample of residents aged≥50\xa0years from urban and rural areas in four districts in Tehran province were enrolled']","['mHealth arm with digital data collection, vision screening test and retina evaluation using an integrated mobile application, the conventional arm with manual data collection and screening tests using Snellen chart and Fundus photography at the local primary healthcare facility, and the control arm with manual data collection without screening tests', 'mobile-based screening programme']","['Eye care utilization', 'eye care utilization', 'eye care utilization which was defined as at least one visit to an optometrist or ophthalmologist']","[{'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517667', 'cui_str': '2520'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0042792', 'cui_str': 'Vision screening'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0183370', 'cui_str': 'Snellen chart'}, {'cui': 'C0200189', 'cui_str': 'Ocular fundus photography'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0885957', 'cui_str': 'Eye care'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0029146', 'cui_str': 'Optometrist'}, {'cui': 'C1704292', 'cui_str': 'Ophthalmologist'}]",3312.0,0.0910638,"Eye care utilization improved (OR = 1.5, 95%CI: 1.2-1.9) among the referred people after the screening programme compared to the utilization before this programme; however, this improvement was significantly higher in the mHealth method (OR: 1.7, 95%CI: 1.2-2.4) compared to the conventional method (OR: 1.2, 95%CI: 0.8-1.8).
","[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Katibeh', 'Affiliation': 'Centre for Global Health, Department of Public Health, Aarhus University , Aarhus, Denmark.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Sabbaghi', 'Affiliation': 'Ophthalmic Research Centre, Shahid Beheshti University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Masomeh', 'Initials': 'M', 'LastName': 'Kalantarion', 'Affiliation': 'Ophthalmic Research Centre, Shahid Beheshti University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Homayoun', 'Initials': 'H', 'LastName': 'Nikkhah', 'Affiliation': 'Ophthalmic Research Centre, Shahid Beheshti University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Batool', 'Initials': 'B', 'LastName': 'Mousavi', 'Affiliation': 'Department of Prevention, Janbazan Medical and Engineering Research Centre , Tehran, Iran.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Beiranvand', 'Affiliation': 'Ophthalmic Research Centre, Shahid Beheshti University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Ahmadieh', 'Affiliation': 'Ophthalmic Research Centre, Shahid Beheshti University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Kallestrup', 'Affiliation': 'Centre for Global Health, Department of Public Health, Aarhus University , Aarhus, Denmark.'}]",Ophthalmic epidemiology,['10.1080/09286586.2020.1768552']
841,32452928,"Targeted Muscle Reinnervation Improves Residual Limb Pain, Phantom Limb Pain, and Limb Function: A Prospective Study of 33 Major Limb Amputees.","BACKGROUND


Targeted muscle reinnervation is an emerging surgical technique to treat neuroma pain whereby sensory and mixed motor nerves are transferred to nearby redundant motor nerve branches. In a recent randomized controlled trial, targeted muscle reinnervation was recently shown to reduce postamputation pain relative to conventional neuroma excision and muscle burying.
QUESTIONS/PURPOSES


(1) Does targeted muscle reinnervation improve residual limb pain and phantom limb pain in the period before surgery to 1 year after surgery? (2) Does targeted muscle reinnervation improve Patient-reported Outcome Measurement System (PROMIS) pain intensity and pain interference scores at 1 year after surgery? (3) After 1 year, does targeted muscle reinnervation improve functional outcome scores (Orthotics Prosthetics User Survey [OPUS] with Rasch conversion and Neuro-Quality of Life [Neuro-QOL])?
METHODS


Data on patients who were ineligible for randomization or declined to be randomized and underwent targeted muscle reinnervation for pain were gathered for the present analysis. Data were collected prospectively from 2013 to 2017. Forty-three patients were enrolled in the study, 10 of whom lacked 1-year follow-up, leaving 33 patients for analysis. The primary outcomes measured were the difference in residual limb and phantom limb pain before and 1 year after surgery, assessed by an 11-point numerical rating scale (NRS). Secondary outcomes were change in PROMIS pain measures and change in limb function, assessed by the OPUS Rasch for upper limbs and Neuro-QOL for lower limbs before and 1 year after surgery.
RESULTS


By 1 year after targeted muscle reinnervation, NRS scores for residual limb pain from 6.4 ± 2.6 to 3.6 ± 2.2 (mean difference -2.7 [95% CI -4.2 to -1.3]; p < 0.001) and phantom limb pain decreased from 6.0 ± 3.1 to 3.6 ± 2.9 (mean difference -2.4 [95% CI -3.8 to -0.9]; p < 0.001). PROMIS pain intensity and pain interference scores improved with respect to residual limb and phantom limb pain (residual limb pain intensity: 53.4 ± 9.7 to 44.4 ± 7.9, mean difference -9.0 [95% CI -14.0 to -4.0]; residual limb pain interference: 60.4 ± 9.3 to 51.7 ± 8.2, mean difference -8.7 [95% CI -13.1 to -4.4]; phantom limb pain intensity: 49.3 ± 10.4 to 43.2 ± 9.3, mean difference -6.1 [95% CI -11.3 to -0.9]; phantom limb pain interference: 57.7 ± 10.4 to 50.8 ± 9.8, mean difference -6.9 [95% CI -12.1 to -1.7]; p ≤ 0.012 for all comparisons). On functional assessment, OPUS Rasch scores improved from 53.7 ± 3.4 to 56.4 ± 3.7 (mean difference +2.7 [95% CI 2.3 to 3.2]; p < 0.001) and Neuro-QOL scores improved from 32.9 ± 1.5 to 35.2 ± 1.6 (mean difference +2.3 [95% CI 1.8 to 2.9]; p < 0.001).
CONCLUSIONS


Targeted muscle reinnervation demonstrates improvement in residual limb and phantom limb pain parameters in major limb amputees. It should be considered as a first-line surgical treatment option for chronic amputation-related pain in patients with major limb amputations. Additional investigation into the effect on function and quality of life should be performed.
LEVEL OF EVIDENCE


Level IV, therapeutic study.",2020,"PROMIS pain intensity and pain interference scores improved with respect to residual limb and phantom limb pain (residual limb pain intensity: 53.4 ± 9.7 to 44.4 ± 7.9, mean difference","['patients with major limb amputations', 'Data on patients who were ineligible for randomization or declined to be randomized and underwent targeted muscle reinnervation for pain were gathered for the present analysis', 'Forty-three patients were enrolled in the study, 10 of whom lacked 1-year follow-up, leaving 33 patients for analysis', '33 Major Limb Amputees', 'major limb amputees']",[],"['phantom limb pain', 'residual limb pain interference', 'PROMIS pain intensity and pain interference scores', 'phantom limb pain interference', 'Neuro-QOL scores', 'residual limb pain and phantom limb pain', 'muscle reinnervation improve Patient-reported Outcome Measurement System (PROMIS) pain intensity and pain interference scores', 'residual limb and phantom limb pain parameters', 'functional assessment, OPUS Rasch scores', 'Residual Limb Pain, Phantom Limb Pain, and Limb Function', 'change in PROMIS pain measures and change in limb function, assessed by the OPUS Rasch for upper limbs and Neuro-QOL for lower limbs', 'targeted muscle reinnervation improve functional outcome scores (Orthotics Prosthetics User Survey [OPUS] with Rasch conversion and Neuro-Quality of Life [Neuro-QOL', 'function and quality of life', 'residual limb and phantom limb pain before and 1 year after surgery, assessed by an 11-point numerical rating scale (NRS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002689', 'cui_str': 'Amputation of limb'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C5191671', 'cui_str': 'Targeted muscle reinnervation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0002695', 'cui_str': 'Amputee'}]",[],"[{'cui': 'C0031315', 'cui_str': 'Phantom limb'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0231508', 'cui_str': 'Reinnervation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C5191671', 'cui_str': 'Targeted muscle reinnervation'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0029365', 'cui_str': 'Orthotic device'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",43.0,0.349661,"PROMIS pain intensity and pain interference scores improved with respect to residual limb and phantom limb pain (residual limb pain intensity: 53.4 ± 9.7 to 44.4 ± 7.9, mean difference","[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Mioton', 'Affiliation': 'L. M. Mioton, G. A. Dumanian, N. Shah, C. S. Qiu, J. H. Ko, S. W. Jordan, Division of Plastic and Reconstructive Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL, USA W. J. Ertl, The Department of Orthopedic Surgery, The University of Oklahoma, Oklahoma City, OK, USA B. K. Potter, J. M. Souza, Department of Surgery, Walter Reed National Military Medical Center, Uniformed Services University of Health Sciences, Bethesda, MD, USA I. L. Valerio, The Department of Plastic Surgery, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Dumanian', 'Affiliation': ''}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'Cecil S', 'Initials': 'CS', 'LastName': 'Qiu', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Ertl', 'Affiliation': ''}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Potter', 'Affiliation': ''}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Souza', 'Affiliation': ''}, {'ForeName': 'Ian L', 'Initials': 'IL', 'LastName': 'Valerio', 'Affiliation': ''}, {'ForeName': 'Jason H', 'Initials': 'JH', 'LastName': 'Ko', 'Affiliation': ''}, {'ForeName': 'Sumanas W', 'Initials': 'SW', 'LastName': 'Jordan', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001323']
842,32453383,Effect of Academic Detailing on Promoting Appropriate Prescribing of Antipsychotic Medication in Nursing Homes: A Cluster Randomized Clinical Trial.,"Importance


Strategies to reduce the inappropriate prescription of antipsychotics have been the focus of recent attention but have shown considerable variation in their effectiveness.
Objective


To evaluate the effectiveness of academic detailing in nursing homes targeting appropriate prescribing of antipsychotics.
Design, Setting, and Participants


We conducted a pragmatic, cluster randomized clinical trial comparing the effect of academic detailing vs usual care on prescribing antipsychotics in 40 nursing homes with 5363 residents in Ontario, Canada. Data were collected from October 2015 to March 2016 and analyzed from April to August 2018. Primary analyses were conducted using intention to treat.
Intervention


Academic detailing delivered by health professionals (eg, nurses or pharmacists) who arranged meetings (with administrators, physicians, pharmacists, nurses, and support workers), presentations, group visits (with 2-6 clinicians), and 1-on-1 visits (traditional academic detailing visits). Academic detailers had direct and ongoing contact with the nursing homes from the time of launch.
Main Outcomes and Measures


The primary outcome, defined at the level of the resident, was whether continuous antipsychotics were dispensed in the past week. Secondary outcomes included prescribing of other psychotropic medications and clinical outcomes and scores. Prescribing outcomes were assessed at baseline and at 3, 6, and 12 months, and clinical outcomes and scores were assessed at baseline and 3 and 6 months.
Results


A total of 40 nursing homes with 5363 residents were randomized, with 18 intervention homes (45.0%; 2303 [42.9%] residents) and 22 control homes (55.0%; 3060 [57.1%] residents). Participants in the intervention and control groups had similar median (interquartile range) age (86 [79-91] years vs 85 [78-90] years) and sex (674 [29.3%] men vs 970 [31.7%] men). At 12 months, there was no statistically significant difference in the frequency of daily antipsychotic use (intervention: 569 patients [25.2%]; control: 769 [25.6%]; odds ratio, 1.06; 95% CI, 0.93-1.20; P = .49). There were no significant differences in the rates of health care utilization, but the intervention group did experience a statistically significant reduction in pain compared with the control group (mean [SD] pain score, 0.30 [0.59] vs 0.38 [0.66]; P < .001) and depression (mean [SD] Depression Rating Scale score, 2.18 [2.37] vs 2.81 [2.65]; P < .001) at 6 months.
Conclusions and Relevance


The intervention did not further reduce antipsychotic prescribing in nursing homes beyond system-level secular trends occurring alongside usual care. Our findings highlight the need for a more targeted approach to quality improvement strategies, including academic detailing, that account for the timing and topic of interventions.
Trial Registration


ClinicalTrials.gov Identifier: NCT02604056.",2020,"There were no significant differences in the rates of health care utilization, but the intervention group did experience a statistically significant reduction in pain compared with the control group (mean [SD] pain score, 0.30 [0.59] vs 0.38 [0.66]; P < .001) and depression (mean [SD] Depression Rating Scale score, 2.18 [2.37] vs 2.81 [2.65]; P < .001) at 6 months.
","['Participants in the intervention and control groups had similar median (interquartile range) age (86 [79-91] years vs 85 [78-90] years) and sex (674 [29.3%] men vs 970 [31.7%] men', '40 nursing homes with 5363 residents were randomized, with 18 intervention homes (45.0%; 2303 [42.9%] residents) and 22 control homes (55.0%; 3060 [57.1%] residents', 'Data were collected from October 2015 to March 2016 and analyzed from April to August 2018', 'Nursing Homes', '40 nursing homes with 5363 residents in Ontario, Canada']","['academic detailing vs usual care on prescribing antipsychotics', 'Antipsychotic Medication', 'Academic Detailing', 'Intervention\n\n\nAcademic detailing delivered by health professionals (eg, nurses or pharmacists) who arranged meetings (with administrators, physicians, pharmacists, nurses, and support workers), presentations, group visits (with 2-6 clinicians), and 1-on-1 visits (traditional academic detailing visits']","['depression (mean [SD] Depression Rating Scale score', 'prescribing of other psychotropic medications and clinical outcomes and scores', 'frequency of daily antipsychotic use', 'pain', 'rates of health care utilization']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4708784', 'cui_str': '31.7'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C4517773', 'cui_str': '42.9'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0085751', 'cui_str': 'Administrators'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1277251', 'cui_str': 'Has support worker'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}]",5363.0,0.142155,"There were no significant differences in the rates of health care utilization, but the intervention group did experience a statistically significant reduction in pain compared with the control group (mean [SD] pain score, 0.30 [0.59] vs 0.38 [0.66]; P < .001) and depression (mean [SD] Depression Rating Scale score, 2.18 [2.37] vs 2.81 [2.65]; P < .001) at 6 months.
","[{'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Tadrous', 'Affiliation': 'ICES, Toronto, Ontario, Canada.'}, {'ForeName': 'Kinwah', 'Initials': 'K', 'LastName': 'Fung', 'Affiliation': 'ICES, Toronto, Ontario, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Desveaux', 'Affiliation': ""Women's College Research Institute, Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Gomes', 'Affiliation': 'ICES, Toronto, Ontario, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Grimshaw', 'Affiliation': 'University of Ottawa School of Epidemiology, Public Health and Preventive Medicine, Ottawa, Ontario, Canada.'}, {'ForeName': 'Chaim M', 'Initials': 'CM', 'LastName': 'Bell', 'Affiliation': 'Department of Medicine, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Noah M', 'Initials': 'NM', 'LastName': 'Ivers', 'Affiliation': 'ICES, Toronto, Ontario, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.5724']
843,32451212,"Efficacy, immunogenicity and safety of a trivalent live human-lamb reassortant rotavirus vaccine (LLR3) in healthy Chinese infants: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


A randomized, double-blind, placebo-controlled multicenter trial was conducted in healthy Chinese infants to assess the efficacy, immunogenicity and safety of a novel trivalent live human-lamb reassortant rotavirus vaccine (LLR3) against rotavirus gastroenteritis (RVGE).
METHODS


Healthy children aged 6-13 weeks were enrolled and randomized (1:1) to either 3 oral doses of LLR3 or placebo according to a 0, 1, 2 month schedule. The objectives were to evaluate vaccine efficacy (VE) against RVGE of any-severity, severe RVGE (sRVGE) and inpatient caused by rotavirus serotypes contained in the vaccine and not contained in the vaccine after the third dose. Immunogenicity was also assayed in a subgroup. All adverse events (AEs) were collected from 30 min after each dose for immediate reaction, even to the entire study period, including the serious AEs (SAEs) and intussusception.
RESULTS


VE against RVGE of any-severity, sRVGE and inpatient caused by any serotype was 56.6% (95% CI: 50.7, 61.8), 70.3% (95% CI: 60.6, 77.6) and 74.0% (95% CI: 57.5, 84.1) respectively. VE against RVGE of any-severity, sRVGE caused by serotypes not contained in vaccine were 54.2% (95% CI: 47.5, 60.1) and 70.4% (95% CI: 60.4, 77.9). The rate of seroconversion and four-fold increase of rotavirus serotype G2-, G3-, and G4-specific IgA is 60.8%, 58.0%, and 60.6% in vaccine group, which was higher than 21.35%, 22.7%, and 23.1% in placebo group (p < 0.0001 for G2, G3, G4), as well as the Geometric Mean Titer (GMT). Through the entire trial, 65.91% and 67.79% of participants reported at least one AE, and 0.02% and 0.02% reported SAEs in the vaccine and placebo groups, respectively. Two intussusception cases were reported both in vaccine and placebo group.
CONCLUSIONS


In Chinese infants, LLR3 provided a substantial protection against RVGE of any-severity, sRVGE and inpatient caused by any serotype, and showed well immunogenicity and safety.",2020,"In Chinese infants, LLR3 provided a substantial protection against RVGE of any-severity, sRVGE and inpatient caused by any serotype, and showed well immunogenicity and safety.","['healthy Chinese infants', 'Healthy children aged 6-13\xa0weeks']","['trivalent live human-lamb reassortant rotavirus vaccine (LLR3', 'novel trivalent live human-lamb reassortant rotavirus vaccine (LLR3', 'LLR3 or placebo', 'placebo']","['efficacy, immunogenicity and safety', 'vaccine efficacy (VE) against RVGE of any-severity, severe RVGE (sRVGE) and inpatient caused by rotavirus serotypes', 'rotavirus serotype G2-, G3-, and G4-specific IgA', 'rate of seroconversion', 'Geometric Mean Titer (GMT', 'Efficacy, immunogenicity and safety', 'immunogenicity and safety', 'Immunogenicity']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0406810', 'cui_str': 'Carney complex'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus vaccine'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0343363', 'cui_str': 'Viral gastroenteritis due to Rotavirus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0035870', 'cui_str': 'Rotavirus'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",,0.734975,"In Chinese infants, LLR3 provided a substantial protection against RVGE of any-severity, sRVGE and inpatient caused by any serotype, and showed well immunogenicity and safety.","[{'ForeName': 'Shengli', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.'}, {'ForeName': 'Jialiang', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing 102629, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Su', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.'}, {'ForeName': 'Yueyue', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing 102629, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.'}, {'ForeName': 'Qingchuan', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing 102629, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.'}, {'ForeName': 'Jiamei', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing 102629, China.'}, {'ForeName': 'Bianli', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Lanzhou Institute of Biological Products Co Ltd, Lanzhou 730046, China.'}, {'ForeName': 'Tai', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing 102629, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing 102629, China. Electronic address: liuyan418@nifdc.org.cn.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Lanzhou Institute of Biological Products Co Ltd, Lanzhou 730046, China. Electronic address: kathzhou@sina.com.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China. Electronic address: 13691354049@163.com.'}]",Vaccine,['10.1016/j.vaccine.2020.04.038']
844,32451220,Effectiveness of a communication skills training program for medical students to identify patients communicative clues.,"OBJECTIVE


This study explores whether an Experiential Training Programme (ETP) in communication skills (CS) improves students' ability to identify patients clues compared to those who follow a non-experiential training throughout their medical studies.
METHOD


Intervention Group (IG): 85 4th-year medical students who received the ETP and Control Group (CG): 67 recently graduated students who did not receive it. Their immediate (written) response was requested to three expressions offered by patients containing communicative clues. The answers were grouped into 2 categories: Clue recognised and response patient-centred and the opposite. Three researchers analysed the answers.
RESULTS


Responses 366 (65 from the CG and 77 from the IG): 280 did not recognise clues: 131 (62%) in IG and 149 (96%) in CG and 86 recognised them: 80 (37.9%) in IG and 6 (3.9%) in CG (p = 0.000). Some clues were more elusive than others (p = 0,003).
CONCLUSIONS


The students who received the ETP in CS showed greater ability to explore patients perspective taking advantage of different types of communicative clues than those who did not receive it in a non-relational context.
PRACTICE IMPLICATIONS


Further research is needed to assess whether this ability is maintained in simulated or real clinical situations.",2020,"Some clues were more elusive than others (p = 0,003).
","['Intervention Group (IG): 85 4th-year medical students who received the', 'medical students to identify patients communicative clues']","['Experiential Training Programme (ETP) in communication skills (CS', 'ETP and Control Group (CG): 67 recently graduated students who did not receive it', 'communication skills training program', 'ETP in CS']",[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0212889,"Some clues were more elusive than others (p = 0,003).
","[{'ForeName': 'Roger Ruiz', 'Initials': 'RR', 'LastName': 'Moral', 'Affiliation': 'School of Medicine, Universidad Francisco de Vitoria, Madrid, Spain; Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, University, Córdoba, Spain. Electronic address: r.ruiz.prof@ufv.es.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Andrade-Rosa', 'Affiliation': 'Department of Primary Care, Los Castillos Health Centre, Alcorcón, Madrid, Spain.'}, {'ForeName': 'Juan D Molina', 'Initials': 'JDM', 'LastName': 'Martín', 'Affiliation': 'Department of Psychiatry, Villaverde Mental Health Centre, Hospital 12 De Octubre, Madrid, Spain.'}, {'ForeName': 'Emilio Cervera', 'Initials': 'EC', 'LastName': 'Barba', 'Affiliation': 'School of Medicine, Universidad Francisco De Vitoria, Madrid, Spain.'}, {'ForeName': 'Luis Pérula', 'Initials': 'LP', 'LastName': 'de Torres', 'Affiliation': 'Department of Primary Care Córdoba, Instituto Maimónides De Investigación Biomédica De Córdoba (IMIBIC), Córdoba University, Córdoba, Spain.'}, {'ForeName': 'Diana Monge', 'Initials': 'DM', 'LastName': 'Martín', 'Affiliation': 'School of Medicine, Universidad Francisco De Vitoria, Madrid, Spain.'}]",Patient education and counseling,['10.1016/j.pec.2020.05.018']
845,32467417,"A nebulised antitumour necrosis factor receptor-1 domain antibody in patients at risk of postoperative lung injury: A randomised, placebo-controlled pilot study.","BACKGROUND


Tumour necrosis factor receptor 1 (TNFR1) signalling mediates the cell death and inflammatory effects of TNF-α.
OBJECTIVE


The current clinical trial investigated the effects of a nebulised TNFR1 antagonist (GSK2862277) on signs of lung injury in patients undergoing oesophagectomy.
DESIGN


Randomised double-blind (sponsor unblind), placebo-controlled, parallel group study.
SETTING


Eight secondary care centres, the United Kingdom between April 2015 and June 2017.
PATIENTS


Thirty-three patients undergoing elective transthoracic oesophagectomy.
INTERVENTIONS


Patients randomly received a single nebulised dose (26 mg) of GSK2862277 (n = 17) or placebo (n = 16), given 1 to 5 h before surgery; 14 and 16, respectively competed the study.
MAIN OUTCOME MEASUREMENTS


Physiological and biochemical markers of lung injury, pharmacokinetic and safety endpoints were measured. The primary endpoint was the change from baseline in pulmonary vascular permeability index (PVPI) at completion of surgery, measured using single-indicator transpulmonary thermodilution. Adjusted point estimates and 95% credible intervals (analogous to conventional confidence intervals) were constructed for each treatment using Bayesian statistical models.
RESULTS


The mean change (with 95% credible intervals) from baseline in PVPI on completion of surgery was 0.00 (-0.23, 0.39) in the placebo and 0.00 (-0.24, 0.37) in the GSK2862277 treatment groups. There were no significant treatment-related differences in PaO2/FiO2 or Sequential Organ Failure Assessment score. Levels of free soluble TNFR1, Macrophage Inflammatory Protein-1 alpha and total protein were significantly reduced in the bronchoalveolar lavage fluid of patients treated with GSK2862277 (posterior probability of decrease with GSK2862277 vs. placebo:≥0.977; equivalent to P < 0.05). The frequency of adverse events and serious adverse events were distributed evenly across the two treatment arms.
CONCLUSION


Pre-operative treatment with a single 26 mg inhaled dose of GSK2862277 did not result in significantly lower postoperative alveolar capillary leak or extra vascular lung water. Unexpectedly small increases in transpulmonary thermodilution-measured PVPI and extra vascular lung water index at completion of surgery suggest less postoperative lung injury than historically reported, which may have also compromised a clear assessment of efficacy in this trial. GSK2862277 was well tolerated, resulted in expected lung exposure and reduced biomarkers of lung permeability and inflammation.
TRIAL REGISTRATION


clinicaltrials.gov: NCT02221037.",2020,"Levels of free soluble TNFR1, Macrophage Inflammatory Protein-1 alpha and total protein were significantly reduced in the bronchoalveolar lavage fluid of patients treated with GSK2862277 (posterior probability of decrease with GSK2862277 vs. placebo:≥0.977; equivalent to P < 0.05).","['patients undergoing oesophagectomy', 'patients at risk of postoperative lung injury', 'Thirty-three patients undergoing elective transthoracic oesophagectomy', 'Eight secondary care centres, the United Kingdom between April 2015 and June 2017']","['GSK2862277', 'nebulised TNFR1 antagonist (GSK2862277', 'nebulised antitumour necrosis factor receptor-1 domain antibody', 'placebo']","['Physiological and biochemical markers of lung injury, pharmacokinetic and safety endpoints', 'PaO2/FiO2 or Sequential Organ Failure Assessment score', 'postoperative alveolar capillary leak or extra vascular lung water', 'Levels of free soluble TNFR1, Macrophage Inflammatory Protein-1 alpha and total protein', 'lung exposure and reduced biomarkers of lung permeability and inflammation', 'frequency of adverse events and serious adverse events', 'pulmonary vascular permeability index (PVPI) at completion of surgery, measured using single-indicator transpulmonary thermodilution']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C4279387', 'cui_str': 'GSK2862277'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1382398', 'cui_str': 'Increased capillary permeability'}, {'cui': 'C0015380', 'cui_str': 'Lung Water, Extravascular'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0128546', 'cui_str': 'Small Inducible Cytokine A3'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0162337', 'cui_str': 'Blood vessel permeability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0039807', 'cui_str': 'Thermodilution'}]",33.0,0.589958,"Levels of free soluble TNFR1, Macrophage Inflammatory Protein-1 alpha and total protein were significantly reduced in the bronchoalveolar lavage fluid of patients treated with GSK2862277 (posterior probability of decrease with GSK2862277 vs. placebo:≥0.977; equivalent to P < 0.05).","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ryan', 'Affiliation': ""From The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough (JR), GlaxoSmithKline Research and Development, Stevenage (AIB, TJW, EM,WP, RW, AF), Centre for Experimental Medicine, Queen's University of Belfast (DFM), Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (DFM), Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry (JY, GDP), Birmingham Acute Care Research Group, Institute of Inflammation and Aging, School of Clinical and Experimental Medicine, University of Birmingham (DRT, PAH), University Hospitals Birmingham, NHS Foundation Trust, Birmingham (JY, DRT, PAH, GDP), Department of Anaesthesia, Royal Victoria Hospital, Belfast (COD, MOS), Department of Medicine, University of Cambridge, Cambridge (AMV, CS), GlaxoSmithKline R&D, Stockley Park (KH), Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK (CS) and GlaxoSmithKline Research and Development, Collegeville, Pennsylvania, USA (ALL).""}, {'ForeName': 'Andrew I', 'Initials': 'AI', 'LastName': 'Bayliffe', 'Affiliation': ''}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ''}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Yeung', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Thickett', 'Affiliation': ''}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Howells', 'Affiliation': ''}, {'ForeName': 'Ciara', 'Initials': 'C', 'LastName': ""O'Donnell"", 'Affiliation': ''}, {'ForeName': 'Arlette M', 'Initials': 'AM', 'LastName': 'Vassallo', 'Affiliation': ''}, {'ForeName': 'Tracey J', 'Initials': 'TJ', 'LastName': 'Wright', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McKie', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Hardes', 'Affiliation': ''}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Summers', 'Affiliation': ''}, {'ForeName': 'Martin O', 'Initials': 'MO', 'LastName': 'Shields', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Powley', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Aili L', 'Initials': 'AL', 'LastName': 'Lazaar', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fowler', 'Affiliation': ''}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001245']
846,32468646,"Nilotinib Effects on Safety, Tolerability, and Biomarkers in Alzheimer's Disease.","OBJECTIVE


Preclinical evidence with nilotinib, a US Food and Drug Administration (FDA)-approved drug for leukemia, indicates improvement in Alzheimer's disease phenotypes. We investigated whether nilotinib is safe, and detectable in cerebrospinal fluid, and alters biomarkers and clinical decline in Alzheimer's disease.
METHODS


This single-center, phase 2, randomized, double-blind, placebo-controlled study investigated the safety, tolerability, and pharmacokinetics of nilotinib, and measured biomarkers in participants with mild to moderate dementia due to Alzheimer's disease. The diagnosis was supported by cerebrospinal fluid or amyloid positron emission tomography biomarkers. Nilotinib 150 mg versus matching placebo was taken orally once daily for 26 weeks followed by nilotinib 300 mg versus placebo for another 26 weeks.
RESULTS


Of the 37 individuals enrolled, 27 were women and the mean (SD) age was 70.7 (6.48) years. Nilotinib was well-tolerated, although more adverse events, particularly mood swings, were noted with the 300 mg dose. In the nilotinib group, central nervous system (CNS) amyloid burden was significantly reduced in the frontal lobe compared to the placebo group. Cerebrospinal fluid Aβ40 was reduced at 6 months and Aβ42 was reduced at 12 months in the nilotinib group compared to the placebo. Hippocampal volume loss was attenuated (-27%) at 12 months and phospho-tau-181 was reduced at 6 months and 12 months in the nilotinib group.
INTERPRETATION


Nilotinib is safe and achieves pharmacologically relevant cerebrospinal fluid concentrations. Biomarkers of disease were altered in response to nilotinib treatment. These data support a larger, longer, multicenter study to determine the safety and efficacy of nilotinib in Alzheimer's disease. ANN NEUROL 2020 ANN NEUROL 2020;88:183-194.",2020,Cerebrospinal fluid Aβ40 was reduced at 6 months and Aβ42 was reduced at 12 months in the nilotinib group compared to the placebo.,"[""participants with mild to moderate dementia due to Alzheimer's disease"", ' 27 were women and the mean (SD) age was 70.7 (6.48) years', '37 individuals enrolled', ""Alzheimer's disease""]","['Nilotinib 150 mg versus matching placebo', 'nilotinib 300 mg versus placebo', 'placebo']","['safety, tolerability, and pharmacokinetics of nilotinib, and measured biomarkers', ""Safety, Tolerability, and Biomarkers in Alzheimer's Disease"", 'Hippocampal volume loss', 'central nervous system (CNS) amyloid burden', 'Cerebrospinal fluid Aβ40', 'safety and efficacy']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C3665464', 'cui_str': ""Dementia in Alzheimer's disease, unspecified""}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C2920193', 'cui_str': 'nilotinib 150 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1721377', 'cui_str': 'nilotinib'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1721377', 'cui_str': 'nilotinib'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",27.0,0.589561,Cerebrospinal fluid Aβ40 was reduced at 6 months and Aβ42 was reduced at 12 months in the nilotinib group compared to the placebo.,"[{'ForeName': 'Raymond S', 'Initials': 'RS', 'LastName': 'Turner', 'Affiliation': 'Memory Disorders Program, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Michaeline L', 'Initials': 'ML', 'LastName': 'Hebron', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Lawler', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Mundel', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Yusuf', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'J Nathan', 'Initials': 'JN', 'LastName': 'Starr', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Anjum', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pagan', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Yasar', 'Initials': 'Y', 'LastName': 'Torres-Yaghi', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Wangke', 'Initials': 'W', 'LastName': 'Shi', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Sanjana', 'Initials': 'S', 'LastName': 'Mulki', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Ferrante', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Matar', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Xiaoguang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Division of Nuclear Medicine, Washington, DC, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Radiology, MedStar Georgetown Hospital, Washington, DC, USA.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Neuroscience, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Jaeil', 'Initials': 'J', 'LastName': 'Ahn', 'Affiliation': 'Department of Biostatistics, Bioinformatics and Biomathematics, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Charbel', 'Initials': 'C', 'LastName': 'Moussa', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}]",Annals of neurology,['10.1002/ana.25775']
847,32468696,"Re: Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT).",,2020,,['women having repeat anterior or posterior prolapse surgery'],"['Re: Mesh inlay, mesh kit or native tissue repair']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",[],,0.19633,,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Maher', 'Affiliation': ""Royal Brisbane and Women's Hospital, University of Queensland, Brisbane, QLD, Australia.""}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'Hartel', 'Affiliation': 'Queensland Institute of Medical Research Berghofer Statistics Unit, Brisbane, QLD, Australia.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16301']
848,32469414,Assessment of Patient and Caregiver Attitudes and Approaches to Decision-Making Regarding Bone Marrow Transplant for Sickle Cell Disease: A Qualitative Study.,"Importance


Bone marrow transplant (BMT) is a potentially curative treatment for sickle cell disease (SCD). Patient and caregiver attitudes toward BMT for SCD and the willingness to accept risks of BMT vary, but these attitudes are not well understood.
Objective


To understand patient and caregiver perceptions of and attitudes toward BMT for SCD and decision-making about BMT.
Design, Setting, and Participants


Qualitative study of interview transcripts from a convenience sample. Transcripts were from adults with SCD and caregivers of patients with SCD recruited from national and regional SCD conferences, symposia, and sickle cell clinics in 2 cities. Interview transcripts were used from the needs assessment phase to develop a patient-decision aid in 2013 to 2014 (group 1) and from the baseline point in 2015 to 2016 (group 2) of the parent trial, a randomized clinical trial of adults and caregivers of patients with SCD to evaluate the effectiveness of a patient decision aid.
Main Outcomes and Measures


Participant perspectives on decision-making regarding BMT for SCD.
Results


Fifty-seven transcripts from adults with SCD and 50 transcripts from caregivers of patients with SCD were included. Median (interquartile range [IQR]) age of adults with SCD was 34 (21-50) years in group 1 and 30 (23-38) years in group 2. The median (IQR) age of caregivers was 42.5 (31-52) years in group 1 and 41 (35-46.5) years in group 2. Most transcripts from adults with SCD (75.0% in group 1 and 72.4% in group 2) and caregivers of patients with SCD (76.7% in group 1 and 85.0% in group 2) were from female participants. Bone marrow transplant was perceived as a treatment option associated with serious risks. Reported attitudes toward BMT occurred on a continuum ranging from unfavorable to favorable. Participants reported serious decisional dilemma regarding BMT for SCD. Most participants expressed interest in learning about BMT or curative treatments.
Conclusions and Relevance


This qualitative study found a continuum in attitudes toward BMT for SCD and highlights the complexity of decision-making in BMT for SCD. Patients and families with SCD expressed an interest in learning about BMT. Future prospective studies of patient decision-making regarding BMT, especially in the context of emerging curative and novel disease-modifying therapies for SCD, are warranted.",2020,Most transcripts from adults with SCD (75.0% in group 1 and 72.4% in group 2) and caregivers of patients with SCD (76.7% in group 1 and 85.0% in group 2) were from female participants.,"['adults with SCD and 50 transcripts from caregivers of patients with SCD', 'sickle cell disease (SCD', 'adults with SCD and caregivers of patients with SCD recruited from national and regional SCD conferences, symposia, and sickle cell clinics in 2 cities', 'Sickle Cell Disease']",['Importance\n\n\nBone marrow transplant (BMT'],['decision-making regarding BMT for SCD'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0221283', 'cui_str': 'Drepanocyte'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0005961', 'cui_str': 'Transplantation of bone marrow'}]","[{'cui': 'C0005961', 'cui_str': 'Transplantation of bone marrow'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}]",,0.0344463,Most transcripts from adults with SCD (75.0% in group 1 and 72.4% in group 2) and caregivers of patients with SCD (76.7% in group 1 and 85.0% in group 2) were from female participants.,"[{'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Bakshi', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Deeksha', 'Initials': 'D', 'LastName': 'Katoch', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Cynthia B', 'Initials': 'CB', 'LastName': 'Sinha', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Ross', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Maa-Ohui', 'Initials': 'MO', 'LastName': 'Quarmyne', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Social and Decision Sciences, Carnegie Mellon University, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Lakshmanan', 'Initials': 'L', 'LastName': 'Krishnamurti', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6742']
849,32521448,Design cues for tobacco communication: Heuristic interpretations and usability of online health information about harmful chemicals.,"OBJECTIVE


Many people have a poor understanding of the numerous chemicals in tobacco products that cause severe health harms. The US government must display a list of these harmful chemicals for the public. Online disclosures are one promising solution, but evidence is needed for effective design strategies to encourage interpretation and use of information as intended.
METHOD


To examine the impact of website designs for the activation of heuristics and usability perceptions, a national probability sample of US adolescents and adults (n = 1441) was randomized in a 3 (chemical format) × 2 (webpage layout) between-subjects online experiment. Chemicals were displayed as names only, with a visual risk indicator, or with numerical ranges. Layouts displayed health harms at the top of the webpage separate from chemicals or the chemicals grouped by associated health harms. Participants viewed a webpage and reported activated heuristics, usability (perceived ease of use and usefulness), and intentions to use the website.
RESULTS


Displaying risk indicators increased website usability by encouraging users to rely on colors to interpret the risk of the chemicals (all p < .01). Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
CONCLUSION


Assessing heuristics gives insights for how US adolescents and adults interpret chemical information and the impact of design strategies on usability. Public disclosures of chemicals in tobacco products could be optimized with color-coded risk indicators and layouts placing chemicals near the harms they cause.",2020,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
",['US adolescents and adults (n = 1441'],[],['website usability'],"[{'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],[],1441.0,0.0625486,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, NC 27599-3365, United States; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC 27599-3365, United States. Electronic address: lazard@unc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104177']
850,32531302,Wound eversion versus planar closure for wounds on the face or neck: A randomized split-wound comparative effectiveness trial.,,2020,,['Wounds on the Face or Neck'],['Wound Eversion Versus Planar Closure'],[],"[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0015211', 'cui_str': 'Eversion'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",[],,0.024742,,"[{'ForeName': 'Claire C', 'Initials': 'CC', 'LastName': 'Alexanian', 'Affiliation': 'Department of Dermatology, University of California, Davis, Sacramento, California; Georgetown University School of Medicine, Washington, DC.'}, {'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Zhuang', 'Affiliation': 'Department of Dermatology, University of California, Davis, Sacramento, California.'}, {'ForeName': 'Milene K', 'Initials': 'MK', 'LastName': 'Crispin', 'Affiliation': 'Department of Dermatology, University of California, Davis, Sacramento, California.'}, {'ForeName': 'April W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'Department of Dermatology, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Eisen', 'Affiliation': 'Department of Dermatology, University of California, Davis, Sacramento, California. Electronic address: deisen123@gmail.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.06.013']
851,32533013,"Local tissue electrical parameters predict oral mucositis in HNSCC patients: A diagnostic accuracy double-blind, randomized controlled trial.","Oral Mucositis (OM) is a common adverse effect of head and neck squamous cell carcinoma (HNSCC) treatment. The purpose of this study was to investigate the significance of early changes in tissue electrical parameters (TEPs) in predicting the development of OM in HNSCC patients receiving radiation therapy (RT). The current study combined two study designs. The first was a case-control study. The control group comprised of RT patients who did not receive head and neck RT, and patients with HNSCC who received RT comprised the case group. In the second part of the study, the case group was included in a parallel cohort. A total of 320 patients were assessed for eligibility, and 135 patients were enrolled. Double blinding was performed, and neither the patients nor the care providers knew the measured parameters. The primary outcome was the detection of between-group changes in local TEPs over the follow-up period. The secondary outcome was the appearance of OM grades II, III, or IV and the predictive value of local TEPs in determining the incidence of OM after RT. The variables, impedance module, resistance, reactance, phase angle, and capacitance, were analyzed by the receiver operator curves (ROC). The case and control groups did not differ in demographic and clinical characteristics. Radiation therapy increased the local impedance module, resistance, reactance, and phase angle and reduced the local tissue capacitance in both groups. Evaluation of TEPs in the first week of RT correlated with the development of OM lesions during cancer therapy. ROC analysis showed that local impedance module and resistance presented higher specificity than did other parameters in predicting OM. In conclusion, local tissue electrical parameters measured at the first RT week can be useful tools to predict oral mucositis.",2020,"Radiation therapy increased the local impedance module, resistance, reactance, and phase angle and reduced the local tissue capacitance in both groups.","['HNSCC patients receiving radiation therapy (RT', 'A total of 320 patients were assessed for eligibility, and 135 patients were enrolled', 'head and neck squamous cell carcinoma (HNSCC', 'HNSCC patients']","['Radiation therapy', 'TEPs']","['local tissue electrical parameters', 'local impedance module, resistance, reactance, and phase angle and reduced the local tissue capacitance', 'Oral Mucositis (OM', 'appearance of OM grades II, III, or IV and the predictive value of local TEPs', 'detection of between-group changes in local TEPs', 'variables, impedance module, resistance, reactance, phase angle, and capacitance', 'OM lesions']","[{'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4517566', 'cui_str': '135'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0242264', 'cui_str': 'Capacitance, Electrical'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",320.0,0.028312,"Radiation therapy increased the local impedance module, resistance, reactance, and phase angle and reduced the local tissue capacitance in both groups.","[{'ForeName': 'Gabriela Luize Guimarães', 'Initials': 'GLG', 'LastName': 'Sanches', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'Agna Soares', 'Initials': 'AS', 'LastName': 'da Silva Menezes', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'Laércio Ives', 'Initials': 'LI', 'LastName': 'Santos', 'Affiliation': 'Instituto Federal do Norte de Minas Gerais, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Cristina Paixão', 'Initials': 'CP', 'LastName': 'Durães', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'Larissa Lopes', 'Initials': 'LL', 'LastName': 'Fonseca', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'Marcelo Perim', 'Initials': 'MP', 'LastName': 'Baldo', 'Affiliation': 'Department of Pathophysiology, Universidade Estadual de Montes Claros, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Thais', 'Initials': 'T', 'LastName': 'de Oliveira Faria', 'Affiliation': 'Department of Pathophysiology, Universidade Estadual de Montes Claros, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Luciano Alves', 'Initials': 'LA', 'LastName': 'de Araújo Andrade', 'Affiliation': 'Dilson Godinho Hospital, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Petr Iakovlevitch', 'Initials': 'PI', 'LastName': 'Ekel', 'Affiliation': 'Pontifícia Universidade Católica de Minas Gerais, Programa de Pós-Graduação em Engenharia Elétrica, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Sérgio Henrique Sousa', 'Initials': 'SHS', 'LastName': 'Santos', 'Affiliation': 'Institute of Agricultural Sciences, Universidade Federal de Minas Gerais (UFMG), Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Alfredo Maurício Batista', 'Initials': 'AMB', 'LastName': 'de Paula', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'Lucyana Conceição', 'Initials': 'LC', 'LastName': 'Farias', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'Marcos Flávio Silveira Vasconcelos', 'Initials': 'MFSV', 'LastName': ""D'Angelo"", 'Affiliation': 'Department of Computer Science, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'André Luiz Sena', 'Initials': 'ALS', 'LastName': 'Guimarães', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil. andreluizguimaraes@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-66351-9']
852,32533015,Influence of the long-term use of oral hygiene products containing stannous ions on the salivary microbiome - a randomized controlled trial.,"Oral hygiene products containing tin are suitable to prevent erosive tooth wear, yet effects on the oral microbiota are not known yet. Therefore, this study determined the salivary microbiome of 16 participants using products with stannous ions for three years (TG) compared with a control group (CG) to assess their influence on the microbiota. Participants were included in a randomized controlled clinical trial (RCT) with biannual visits. Illumina Miseq sequencing revealed as most abundant genera: Streptococcus (TG 14.3%; CG 13.0%), Veillonella (TG 11.3%; CG 10.9%), Prevotella (TG 7.0%; CG 9.8%), Haemophilus (TG 6.6%; CG 7.2%), Porphyromonas (TG 5.9%, CG 5.1%), Leptotrichia (TG 5.8%; CG 4.9%), Actinomyces (TG 4.0%; CG 4.6%) and Neisseria (TG 5.4%; CG 4.2%). Beta-Diversity was not significantly different between groups at both time points, although significant differences between groups were found for certain taxa after three years. The genus Prevotella was found in higher abundance in CG whereas Neisseria and Granulicatella, health-associated taxa, were found more abundantly in TG. Salivary microbiota after three years reflected a composition associated with oral health, hence continual use as a preventive measure for dental erosion can be considered safe and benefitting oral health for patients with a high risk of erosion.",2020,"Beta-Diversity was not significantly different between groups at both time points, although significant differences between groups were found for certain taxa after three years.","['patients with a high risk of erosion', '16 participants using products with stannous ions for three years (TG']","['control group (CG', 'oral hygiene products containing stannous']","['Beta-Diversity', 'Salivary microbiota']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",16.0,0.0518899,"Beta-Diversity was not significantly different between groups at both time points, although significant differences between groups were found for certain taxa after three years.","[{'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Anderson', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. annette.anderson@uniklinik-freiburg.de.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Al-Ahmad', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Schlueter', 'Affiliation': 'Division for Cariology, Department of Operative Dentistry and Periodontology, Medical Center- University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Frese', 'Affiliation': 'Department of Conservative Dentistry, Clinic for Oral, Dental and Maxillofacial Diseases, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hellwig', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Binder', 'Affiliation': 'Institute for Prevention and Cancer Epidemiology, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}]",Scientific reports,['10.1038/s41598-020-66412-z']
853,32533085,Remote ischemic conditioning in active ulcerative colitis: An explorative randomized clinical trial.,"Remote ischemic conditioning (RIC) by repetitive brief periods of limb ischemia and reperfusion renders organs more resistant to ischemic injury. The protection is partly through down-regulation of the inflammatory response. Our aim was to investigate the clinical and anti-inflammatory effects of RIC in patients with active ulcerative colitis (UC). We included 22 patients with active UC in this explorative, randomized, sham-controlled clinical trial. The patients were randomly assigned 1:1 to RIC (induced in the arm through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff) or sham (incomplete inflation of the blood-pressure cuff) once daily for 10 days. Outcome variables were measured at baseline and on day 11. When compared with sham, RIC did not affect inflammation in the UC patients measured by fecal calprotectin, plasma C-reactive protein, Mayo Score, Mayo Endoscopic Subscore, Nancy Histological Index or inflammatory cytokines involved in UC and RIC. The mRNA and miRNA expression profiles in the UC patients were measured by RNA sequencing and multiplexed hybridization, respectively, but were not significantly affected by RIC. We used the Langendorff heart model to assess activation of the organ protective mechanism induced by RIC, but could not confirm activation of the organ protective mechanism in the UC patients.",2020,"When compared with sham, RIC did not affect inflammation in the UC patients measured by fecal calprotectin, plasma C-reactive protein, Mayo Score, Mayo Endoscopic Subscore, Nancy Histological Index or inflammatory cytokines involved in UC and RIC.","['22 patients with active UC', 'active ulcerative colitis', 'patients with active ulcerative colitis (UC']","['5-min inflation and 5-min deflation of a blood-pressure cuff) or sham (incomplete inflation of the blood-pressure cuff', 'Remote ischemic conditioning', 'RIC', 'Remote ischemic conditioning (RIC']","['fecal calprotectin, plasma C-reactive protein, Mayo Score, Mayo Endoscopic Subscore, Nancy Histological Index or inflammatory cytokines involved in UC and RIC', 'mRNA and miRNA expression profiles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0180208', 'cui_str': 'Blood pressure cuff'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",22.0,0.210465,"When compared with sham, RIC did not affect inflammation in the UC patients measured by fecal calprotectin, plasma C-reactive protein, Mayo Score, Mayo Endoscopic Subscore, Nancy Histological Index or inflammatory cytokines involved in UC and RIC.","[{'ForeName': 'Line E', 'Initials': 'LE', 'LastName': 'Godskesen', 'Affiliation': 'Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Lassen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Nichlas R', 'Initials': 'NR', 'LastName': 'Jespersen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Majken', 'Initials': 'M', 'LastName': 'Siersbæk', 'Affiliation': 'Department of Biochemistry and Molecular Biology, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Interdisciplinary Nanoscience Center (iNANO), Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Nielsen', 'Affiliation': 'Internal Medicine & Emergency Department, Odense University Hospital - Svendborg Sygehus, Svendborg, Denmark.'}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Tjønnfjord', 'Affiliation': 'Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Grøntved', 'Affiliation': 'Department of Biochemistry and Molecular Biology, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Gunvor', 'Initials': 'G', 'LastName': 'Madsen', 'Affiliation': 'Department of Pathology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Kjems', 'Affiliation': 'Interdisciplinary Nanoscience Center (iNANO), Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Hans E', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Schmidt', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Krag', 'Affiliation': 'Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark. aleksander.krag@rsyd.dk.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kjeldsen', 'Affiliation': 'Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark.'}]",Scientific reports,['10.1038/s41598-020-65692-9']
854,32541662,A Feedforward Loop within the Thyroid-Brown Fat Axis Facilitates Thermoregulation.,"Thyroid hormones (TH) control brown adipose tissue (BAT) activation and differentiation, but their subsequent homeostatic response following BAT activation remains obscure. This study aimed to investigate the relationship between cold- and capsinoids-induced BAT activation and TH changes between baseline and 2 hours post-intervention. Nineteen healthy subjects underwent  18 F-fluorodeoxyglucose positron-emission tomography ( 18 F-FDG PET) and whole-body calorimetry (WBC) after 2 hours of cold exposure (~14.5 °C) or capsinoids ingestion (12 mg) in a crossover design. Standardized uptake values (SUV-mean) of the region of interest and energy expenditure (EE) were measured. Plasma free triiodothyronine (FT3), free thyroxine (FT4) and thyroid stimulating hormone (TSH) were measured before and 2 hours after each intervention. Subjects were divided into groups based on the presence (n = 12) or absence (n = 7) of BAT after cold exposure. 12 of 19 subjects were classified as BAT-positive. Subjects with BAT had higher baseline FT3 concentration, baseline FT3/FT4 ratio compared with subjects without BAT. Controlling for body fat percentage, FT3 concentration at baseline was associated with EE change from baseline after cold exposure (P = 0.037) and capsinoids (P = 0.047). Plasma FT4 level significantly increased associated with reciprocal decline in TSH after acute cold exposure and capsinoids independently of subject and treatment status. Circulating FT3 was higher in BAT-positive subjects and was a stronger predictor of EE changes after cold exposure and capsinoids in healthy humans. BAT activation elevates plasma FT4 acutely and may contribute towards augmentation of thermogenesis via a positive feedback response.",2020,Circulating FT3 was higher in BAT-positive subjects and was a stronger predictor of EE changes after cold exposure and capsinoids in healthy humans.,"['12 of 19 subjects were classified as BAT-positive', 'healthy humans', 'Nineteen healthy subjects underwent']",['18 F-fluorodeoxyglucose positron-emission tomography ( 18 F-FDG PET) and whole-body calorimetry (WBC) after 2\u2009hours of cold exposure (~14.5\u2009°C) or capsinoids ingestion'],"['Plasma FT4 level', 'Thyroid hormones (TH) control brown adipose tissue (BAT) activation and differentiation', 'BAT activation and TH changes', 'body fat percentage, FT3 concentration', 'baseline FT3 concentration, baseline FT3/FT4 ratio', 'Standardized uptake values (SUV-mean) of the region of interest and energy expenditure (EE', 'Circulating FT3', 'Plasma free triiodothyronine (FT3), free thyroxine (FT4) and thyroid stimulating hormone (TSH']","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0302995', 'cui_str': 'Fluorine-18'}, {'cui': 'C3641247', 'cui_str': 'FDG PET scan'}, {'cui': 'C0046056', 'cui_str': 'Fluorodeoxyglucose F18'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0006779', 'cui_str': 'Calorimetry'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0231275', 'cui_str': 'Cold exposure'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0560014', 'cui_str': 'ft3'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0370097', 'cui_str': 'Free triiodothyronine'}, {'cui': 'C0202225', 'cui_str': 'T4 free measurement'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}]",19.0,0.0475415,Circulating FT3 was higher in BAT-positive subjects and was a stronger predictor of EE changes after cold exposure and capsinoids in healthy humans.,"[{'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Singapore Institute for Clinical Sciences, Agency for Science, Technology and Research (A*STAR), Singapore, Singapore.'}, {'ForeName': 'Hui Jen', 'Initials': 'HJ', 'LastName': 'Goh', 'Affiliation': 'Singapore Institute for Clinical Sciences, Agency for Science, Technology and Research (A*STAR), Singapore, Singapore.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Govindharajulu', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research (A*STAR), Singapore, Singapore.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Cardiovascular and Metabolic Disorders Program, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Christiani Jeyakumar', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research (A*STAR), Singapore, Singapore.'}, {'ForeName': 'Melvin Khee-Shing', 'Initials': 'MK', 'LastName': 'Leow', 'Affiliation': 'Singapore Institute for Clinical Sciences, Agency for Science, Technology and Research (A*STAR), Singapore, Singapore. melvin_leow@sics.a-star.edu.sg.'}]",Scientific reports,['10.1038/s41598-020-66697-0']
855,32534972,"Comparison of Clinical Performance of VectorFlow and Palindrome Symmetric-Tip Dialysis Catheters: A Multicenter, Randomized Trial.","PURPOSE


To compare clinical performance of 2 widely used symmetric-tip hemodialysis catheters.
MATERIALS AND METHODS


Patients with end-stage renal disease initiating or resuming hemodialysis were randomized to receive an Arrow-Clark VectorFlow (n = 50) or Palindrome catheter (n = 50). Primary outcome was 90-d primary unassisted catheter patency. Secondary outcomes were Kt/V ([dialyzer urea clearance × total treatment time]/total volume of urea distribution), urea reduction ratio (URR), and effective blood flow (Q B ).
RESULTS


Primary unassisted patency rates with the VectorFlow catheter at 30, 60, and 90 d were 95.5% ± 3.3, 87.2% ± 7.3, and 80.6% ± 9.8, respectively, compared with 89.1% ± 6.2, 79.4% ± 10.0, and 71.5% ± 12.6 with the Palindrome catheter (P = .20). Patients with VectorFlow catheters had a mean Kt/V of 1.5 at 30-, 60-, and 90-day time points, significantly higher than the mean Kt/V of 1.3 among those with Palindrome catheters (P = .0003). URRs were not significantly different between catheters. Catheter Q B  rates exceeded National Kidney Foundation-recommended thresholds of 300 mL/min at all time points for both catheters and were similar for both catheters (median, 373 mL/min). Catheter failure, ie, poor flow rate requiring guide-wire exchange or removal, within the 90-day primary outcome occurred in 3 VectorFlow subjects and 5 Palindrome subjects (P = .72). Infection rates were similar, with 0.98 infections per 1,000 catheter days for VectorFlow catheters compared with 2.62 per 1,000 catheter days for Palindrome catheters (P = .44).
CONCLUSIONS


The 90-day primary patency rates of Palindrome and VectorFlow catheters were not significantly different, and both achieved sustained high Q B  through 90 day follow-up. However, dialysis adequacy based on Kt/V was consistently better with the VectorFlow catheter versus the Palindrome.",2020,"Catheter Q B  rates exceeded National Kidney Foundation-recommended thresholds of 300 mL/min at all time points for both catheters and were similar for both catheters (median, 373 mL/min).",['Patients with end-stage renal disease initiating or resuming hemodialysis'],"['VectorFlow catheters', 'VectorFlow catheter versus the Palindrome', 'Arrow-Clark VectorFlow (n\xa0= 50) or Palindrome catheter', 'VectorFlow and Palindrome Symmetric-Tip Dialysis Catheters']","['Kt/V ([dialyzer urea clearance', '90-day primary patency rates of Palindrome and VectorFlow catheters', 'patency rates', '90-d primary unassisted catheter patency', 'Infection rates', 'Catheter failure, ie, poor flow rate requiring guide-wire exchange or removal', 'urea distribution), urea reduction ratio (URR), and effective blood flow (Q B ', 'URRs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0336721', 'cui_str': 'Arrow'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0179747', 'cui_str': 'Dialysis catheter'}]","[{'cui': 'C0429662', 'cui_str': 'kt/V'}, {'cui': 'C1318428', 'cui_str': 'Urea clearance measurement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0429664', 'cui_str': 'Urea reduction ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",,0.066622,"Catheter Q B  rates exceeded National Kidney Foundation-recommended thresholds of 300 mL/min at all time points for both catheters and were similar for both catheters (median, 373 mL/min).","[{'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Nadolski', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104. Electronic address: gregory.nadolski@pennmedicine.upenn.edu.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Redmond', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Shin', 'Affiliation': 'Penn State Health Radiology, Hershey, Pennsylvania.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Shamimi-Noori', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Ansar', 'Initials': 'A', 'LastName': 'Vance', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hammelman', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Timothy W I', 'Initials': 'TWI', 'LastName': 'Clark', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Cohen', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rudnick', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2020.02.001']
856,32535135,Induction of sustained unresponsiveness after egg oral immunotherapy compared to baked egg therapy in children with egg allergy.,"BACKGROUND


While desensitization and sustained unresponsiveness (SU) have been shown with egg oral immunotherapy (OIT), the benefits of baked egg (BE) therapy for egg allergy have not been well studied.
OBJECTIVES


This study sought to evaluate the safety and efficacy of BE ingestion compared with egg OIT in participants allergic to unbaked egg but tolerant to BE.
METHODS


Children who are BE-tolerant but unbaked egg reactive ages 3 to 16 years were randomized to 2 years of treatment with either BE or egg OIT. Double-blind, placebo-controlled food challenges were conducted after 1 and 2 years of treatment to assess for desensitization, and after 2 years of treatment followed by 8 to 10 weeks off of treatment to assess for SU. Mechanistic studies were conducted to assess for immune modulation. A cohort of participants who are BE-reactive underwent egg OIT and identical double-blind, placebo-controlled food challenges as a comparator group.
RESULTS


Fifty participants (median age 7.3 years) were randomized and initiated treatment. SU was achieved in 3 of 27 participants assigned to BE (11.1%) versus 10 of 23 participants assigned to egg OIT (43.5%) (P = .009). In the BE-reactive comparator group, 7 of 39 participants (17.9%) achieved SU. More participants who are BE-tolerant withdrew from BE versus from egg OIT (29.6% vs 13%). Dosing symptom frequency in participants who are BE-tolerant was similar with BE and egg OIT, but more frequent in participants who are BE-reactive. Egg white-specific IgE, skin testing, and basophil activation decreased similarly after BE and egg OIT.
CONCLUSIONS


Among children allergic to unbaked egg but tolerant to BE, those treated with egg OIT were significantly more likely to achieve SU than were children ingesting BE.",2020,"Egg white-specific IgE, skin testing and basophil activation decreased similarly after BE and egg OIT.
","['BE tolerant but unbaked egg reactive children ages 3-16 years', 'participants allergic to unbaked egg but tolerant to BE', 'egg-allergic children', 'Fifty participants (median age 7.3 years']","['baked egg therapy', 'egg oral immunotherapy (OIT', 'BE or egg OIT', 'placebo-controlled food challenges (DBPCFC', 'egg OIT and identical DBPCFCs']","['SU', 'Egg white-specific IgE, skin testing and basophil activation']","[{'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]","[{'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0205280', 'cui_str': 'Identical'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C1270739', 'cui_str': 'Egg white specific immunoglobulin E'}, {'cui': 'C0037296', 'cui_str': 'Hypersensitivity skin testing'}, {'cui': 'C0004827', 'cui_str': 'Basophils'}]",50.0,0.291217,"Egg white-specific IgE, skin testing and basophil activation decreased similarly after BE and egg OIT.
","[{'ForeName': 'Edwin H', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine and Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC. Electronic address: edwinkim@email.unc.edu.'}, {'ForeName': 'Tamara T', 'Initials': 'TT', 'LastName': 'Perry', 'Affiliation': ""Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wood', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Rockville.'}, {'ForeName': 'Donald Y M', 'Initials': 'DYM', 'LastName': 'Leung', 'Affiliation': 'Department of Pediatrics, National Jewish Health, Denver, Colo.'}, {'ForeName': 'M Cecilia', 'Initials': 'MC', 'LastName': 'Berin', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'A Wesley', 'Initials': 'AW', 'LastName': 'Burks', 'Affiliation': 'Department of Medicine and Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Christine B', 'Initials': 'CB', 'LastName': 'Cho', 'Affiliation': 'Department of Pediatrics, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Stacie M', 'Initials': 'SM', 'LastName': 'Jones', 'Affiliation': ""Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Scurlock', 'Affiliation': ""Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.""}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Sicherer', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Alice K', 'Initials': 'AK', 'LastName': 'Henning', 'Affiliation': 'Emmes, Rockville, Md.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'Emmes, Rockville, Md.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Lindblad', 'Affiliation': 'Emmes, Rockville, Md.'}, {'ForeName': 'Marshall', 'Initials': 'M', 'LastName': 'Plaut', 'Affiliation': 'National Institutes of Health/National Institutes of Allergy and Infectious Diseases, Bethesda, Md.'}, {'ForeName': 'Hugh A', 'Initials': 'HA', 'LastName': 'Sampson', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.05.040']
857,32554218,Potential benefits of environmental volunteering programs of the health of older adults: a pilot study.,"PURPOSE


To study the effects of participating in a 12-week environmental volunteering program on the physical performance of older adults across different age groups MATERIALS AND METHODS: We conducted a pretest-posttest pilot study with a single group. The intervention consisted of twice-weekly recycling activities and once-weekly rehabilitation exercise at community-based care centers. The recycling activities of the environmental volunteering program included sorting and handling paper products, plastics, and metals; disposing electronic products; and sorting clothes. The rehabilitation exercise program comprised a 90-min course for special needs and 30 min of health education. The evaluation tools were the handgrip strength, five-times-sit-to-stand test, sit-and-reach test, Timed Up and Go (TUG) test and usual and fast gait speeds.
RESULTS


In total, 45 participants completed the program. After the program, the participants showed significantly great improvements compared to baseline in all outcome measures. We further divided these participants into two age subgroups [65-75 years (n = 31) and >75 years (n = 14)]. The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed. However, the >75-year subgroup showed significant improvements in all outcome measures.
CONCLUSIONS


This innovative environmental volunteering program conducted in a local Taiwanese community can be a sustainable and feasible model to improve physical performance in the participants, the subgroup aged >75 years in particular. It also provides a potential avenue for researchers and policymakers to address environmental and aging-related issues.",2020,"The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed.","['older adults across different age groups', 'older adults', 'participants into two age subgroups [65-75 years (n\u2009=\u200931) and >75 years (n\u2009=\u200914', 'participants, the subgroup aged >75 years in particular', '45 participants completed the program']","['twice-weekly recycling activities and once-weekly rehabilitation exercise at community-based care centers', 'rehabilitation exercise program', 'environmental volunteering program', 'environmental volunteering programs']","['handgrip strength, TUG and usual gait speed', 'handgrip strength, five-times-sit-to-stand test, sit-and-reach test, Timed Up and Go (TUG) test and usual and fast gait speeds']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0282114', 'cui_str': 'Recycling'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",45.0,0.0265483,"The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed.","[{'ForeName': 'Jia-Ching', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Department of Physical Therapy, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Qi-Xing', 'Initials': 'QX', 'LastName': 'Chang', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Chung-Chao', 'Initials': 'CC', 'LastName': 'Liang', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Department of Medicine, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Jyh-Gang', 'Initials': 'JG', 'LastName': 'Hsieh', 'Affiliation': 'Department of Family Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Peter Pin-Sung', 'Initials': 'PP', 'LastName': 'Liu', 'Affiliation': 'Center for Aging and Health, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Chia-Feng', 'Initials': 'CF', 'LastName': 'Yen', 'Affiliation': 'Department of Public Health, Tzu Chi University, Hualien, Taiwan. Electronic address: mapleyeng@gmail.com.'}, {'ForeName': 'Ching-Hui', 'Initials': 'CH', 'LastName': 'Loh', 'Affiliation': 'Department of Family Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Center for Aging and Health, Buddhist Tzu Chi General Hospital, Hualien, Taiwan. Electronic address: twdoc1960@gmail.com.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104113']
858,32555432,Touching the social robot PARO reduces pain perception and salivary oxytocin levels.,"Human-human social touch improves mood and alleviates pain. No studies have so far tested the effect of human-robot emotional touch on experimentally induced pain ratings, on mood and on oxytocin levels in healthy young adults. Here, we assessed the effect of touching the robot PARO on pain perception, on mood and on salivary oxytocin levels, in 83 young adults. We measured their perceived pain, happiness state, and salivary oxytocin. For the 63 participants in the PARO group, pain was assessed in three conditions: Baseline, Touch (touching PARO) and No-Touch (PARO present). The control group (20 participants) underwent the same measurements without ever encountering PARO. There was a decrease in pain ratings and in oxytocin levels and an increase in happiness ratings compared to baseline only in the PARO group. The Touch condition yielded a larger decrease in pain ratings compared to No-Touch. These effects correlated with the participants' positive perceptions of the interaction with PARO. Participants with higher perceived ability to communicate with PARO experienced a greater hypoalgesic effect when touching PARO. We show that human-robot social touch is effective in reducing pain ratings, improving mood and - surprisingly - reducing salivary oxytocin levels in adults.",2020,There was a decrease in pain ratings and in oxytocin levels and an increase in happiness ratings compared to baseline only in the PARO group.,"['63 participants in the PARO group', 'adults', '83 young adults', 'healthy young adults']",['Human-human social touch'],"['salivary oxytocin levels', 'pain ratings and in oxytocin levels', 'mood and alleviates pain', 'perceived pain, happiness state, and salivary oxytocin', 'pain perception, on mood and on salivary oxytocin levels', 'pain', 'happiness ratings', 'pain ratings', 'pain perception and salivary oxytocin levels']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0152054', 'cui_str': 'Touch'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",83.0,0.0710033,There was a decrease in pain ratings and in oxytocin levels and an increase in happiness ratings compared to baseline only in the PARO group.,"[{'ForeName': 'Nirit', 'Initials': 'N', 'LastName': 'Geva', 'Affiliation': 'Recanati School for Community Health Professions, Department of Physical Therapy, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Florina', 'Initials': 'F', 'LastName': 'Uzefovsky', 'Affiliation': 'Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Levy-Tzedek', 'Affiliation': 'Recanati School for Community Health Professions, Department of Physical Therapy, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. shelly@bgu.ac.il.'}]",Scientific reports,['10.1038/s41598-020-66982-y']
859,32559123,Highlighting Prosocial Affordances of Science in Textbooks to Promote Science Interest.,"The prevalent stereotype that scientific fields do not afford opportunities to fulfill goals of helping others deters student interest and participation in science. We investigated whether introductory college science textbooks that highlight the prosocial utility value of science can be used to change beliefs about the affordances of scientific work. In study 1, undergraduate students who were randomly assigned to read a science textbook chapter with added prosocial utility value expressed greater beliefs that the science topic afforded prosocial goals and increased interest in the scientific topic, compared with two control conditions. Mediation analysis demonstrated that interest was enhanced through increased beliefs that the topic afforded prosocial opportunities. Multiple group comparison tests indicated that underrepresented minority students (i.e., African Americans, Latinos, and Native Americans) might benefit the most from efforts to strengthen prosocial affordance beliefs. In study 2, we conducted a brief landscape analysis of science textbooks and found that texts are missing opportunities to emphasize the prosocial utility value of science. We discuss recommendations for science educators, curriculum designers, and researchers who want to increase and broaden science participation.",2020,Mediation analysis demonstrated that interest was enhanced through increased beliefs that the topic afforded prosocial opportunities.,"['underrepresented minority students (i.e., African Americans, Latinos, and Native Americans', 'undergraduate students']",['science textbook chapter with added prosocial utility value expressed greater beliefs that the science topic afforded prosocial goals'],[],"[{'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}]","[{'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0039712', 'cui_str': 'Textbooks'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",[],,0.0293534,Mediation analysis demonstrated that interest was enhanced through increased beliefs that the topic afforded prosocial opportunities.,"[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Zambrano', 'Affiliation': 'Rossier School of Education, University of Southern California, Los Angeles, CA 90089-4035.'}, {'ForeName': 'Garam Ann', 'Initials': 'GA', 'LastName': 'Lee', 'Affiliation': 'College of Education, Michigan State University, East Lansing, MI 48824.'}, {'ForeName': 'Christina C', 'Initials': 'CC', 'LastName': 'Leal', 'Affiliation': 'Warner School of Education, University of Rochester, Rochester, NY 14627.'}, {'ForeName': 'Dustin B', 'Initials': 'DB', 'LastName': 'Thoman', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, CA 92182.'}]",CBE life sciences education,['10.1187/cbe.19-09-0176']
860,32561824,Semaphorin 3 C is a Novel Adipokine Representing Exercise-Induced Improvements of Metabolism in Metabolically Healthy Obese Young Males.,"This study investigated the endurance exercise-induced changes in lesser known adipokines (visfatin, chemerin, apelin, semaphorin 3 C) related to obesity and metabolism, and their correlations with the changes in the parameters of obesity and glucose homeostasis. Forty metabolically healthy obese young males were randomly assigned to control group (C, n = 12) or exercise group (Ex, n = 28). The subjects in Ex participated in a 8-week supervised endurance exercise training program, comprised of four sessions of treadmill running at 65-70% of VO 2max  per week. Serum levels of visfatin, chemerin, apelin, and semaphorin 3 C were significantly decreased in Ex. At baseline, apelin and semaphorin 3 C appeared to be correlated with obesity measures, including body mass index, % total fat and trunk fat, and waist circumference. Exercise-induced changes in these obesity measures significantly correlated with the changes in chemerin and semaphorin 3 C. Basal chemerin, apelin and semaphorin 3 C correlated with glucose homeostasis parameters, including fasting plasma glucose, fasting plasma insulin, homeostasis model assessment of insulin resistance and β-cell function, and quantitative insulin-sensitivity check index to different extents. Furthermore, the changes in apelin and semaphorin 3 C well predicted the improvements in glycemic parameters. We suggest that semaphorin 3 C is a novel adipokine involved in pathophysiology of obesity and metabolism, and that it is a biomarker representing an exercise-induced improvement in metabolically healthy obese young males.",2020,"Serum levels of visfatin, chemerin, apelin, and semaphorin 3 C were significantly decreased in Ex.","['Metabolically Healthy Obese Young Males', 'Forty metabolically healthy obese young males', 'metabolically healthy obese young males']","['supervised endurance exercise training program', 'control group (C, n\u2009=\u200912) or exercise']","['glycemic parameters', 'fasting plasma glucose, fasting plasma insulin, homeostasis model assessment of insulin resistance and β-cell function, and quantitative insulin-sensitivity check index', 'Serum levels of visfatin, chemerin, apelin, and semaphorin 3\u2009C', 'body mass index, % total fat and trunk fat, and waist circumference']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0068707', 'cui_str': 'Nicotinamide phosphoribosyltransferase'}, {'cui': 'C3542402', 'cui_str': 'Apelin'}, {'cui': 'C1136368', 'cui_str': 'Semaphorin-3'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}]",40.0,0.0146105,"Serum levels of visfatin, chemerin, apelin, and semaphorin 3 C were significantly decreased in Ex.","[{'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Nam', 'Affiliation': 'Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chul Woo', 'Initials': 'CW', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hye Jun', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Graduate School of Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yu Sik', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Severance Institute for Vascular and Metabolic Research, Yonsei University College of Medicine, Seoul, Korea. cromoton@yuhs.ac.'}]",Scientific reports,['10.1038/s41598-020-67004-7']
861,32561877,Effect of 9-month Pilates program on sagittal spinal curvatures and hamstring extensibility in adolescents: randomised controlled trial.,"The percentage of spine misalignment increases during the childhood and adolescence stages. The Pilates method has been associated with an improvement in the sagittal spine disposition, but no studies have been conducted on adolescents. Therefore, the present study aimed to evaluate the effectiveness of a 9-month Pilates exercise program (PEP) on hamstring extensibility and sagittal spinal curvatures on adolescents. This randomised controlled trial included 236 adolescents. The experimental group (EG) received a PEP (9 months, 2 sessions/week, 15 minutes/session). The control group (CG) did not receive any intervention. Hamstring extensibility was measured with the passive and active straight leg raise and toe-touch tests. Sagittal spinal curvatures and pelvic tilt was assessed in relaxed standing, active alignment and toe-touch test positions. The EG had significant changes in hamstring extensibility, lumbar curvature and pelvic tilt in standing sagittal curvature. The CG became significantly worse in thoracic kyphosis in standing. This study provides evidence of nine-months of a PEP increased the hamstring extensibility; averted the increase of the thoracic curvature, and decreased the curvature of the lumbar lordosis and pelvic tilt in standing position; avoided a greater increase of thoracic curvature in active alignment in standing position; and avoided the increase of thoracic curvature in trunk flexion.",2020,"The EG had significant changes in hamstring extensibility, lumbar curvature and pelvic tilt in standing sagittal curvature.","['hamstring extensibility and sagittal spinal curvatures on adolescents', '236 adolescents', 'adolescents']","['PEP', 'Pilates program', 'Pilates exercise program (PEP']","['Sagittal spinal curvatures and pelvic tilt', 'percentage of spine misalignment', 'Hamstring extensibility', 'hamstring extensibility, lumbar curvature and pelvic tilt in standing sagittal curvature', 'thoracic curvature', 'hamstring extensibility', 'sagittal spinal curvatures and hamstring extensibility']","[{'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0037932', 'cui_str': 'Curvature of spine'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C1321049', 'cui_str': 'Pilates exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0037932', 'cui_str': 'Curvature of spine'}, {'cui': 'C1629036', 'cui_str': 'Pelvic declination'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C1275957', 'cui_str': 'Misalignment'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}]",236.0,0.0207577,"The EG had significant changes in hamstring extensibility, lumbar curvature and pelvic tilt in standing sagittal curvature.","[{'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'González-Gálvez', 'Affiliation': 'Research Group on Health, Physical Activity, Fitness and Motor Behaviour (GISAFFCOM), Catholic University of San Antonio of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Pablo Jorge', 'Initials': 'PJ', 'LastName': 'Marcos-Pardo', 'Affiliation': 'Research Group on Health, Physical Activity, Fitness and Motor Behaviour (GISAFFCOM), Catholic University of San Antonio of Murcia (UCAM), Murcia, Spain. pmarcos@ucam.edu.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Trejo-Alfaro', 'Affiliation': 'Research Group on Health, Physical Activity, Fitness and Motor Behaviour (GISAFFCOM), Catholic University of San Antonio of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Vaquero-Cristóbal', 'Affiliation': 'Research Group on Prevention of Lesions in Sports, Catholic University of San Antonio of Murcia (UCAM), Murcia, Spain.'}]",Scientific reports,['10.1038/s41598-020-66641-2']
862,32569090,"Intrathecal delivery of hydromorphone vs morphine for refractory cancer pain: a multicenter, randomized, single-blind, controlled noninferiority trial.","Hydromorphone is an alternative to morphine for intrathecal drug delivery system to treat refractory cancer pain; however, there is not enough clinical evidence to prove it. In our study, 233 patients from 12 different pain management centers across China were enrolled, 121 and 112 in the intrathecal hydromorphone (ITHM) and intrathecal morphine (ITMO) groups, respectively. The primary outcome was the clinical success rate, which was defined as ratio of patients achieving ≥50% pain relief. The noninferiority margin was defined as -0.15. Other outcomes included daily visual analogue scale score, breakthrough pain (BTP) incidence, intrathecal dose change, and patient-controlled analgesia bolus count change, GAD-7/PHQ-9. Clinical success was achieved in 85 and 79 of the 121 ITHM patients (70.2%) and 112 ITMO patients (70.5%), respectively. Compared to the corresponding baseline findings, significantly decreased visual analogue scale scores and BTP incidence were noted in both groups. The dose change rate decreased and increased with time in the ITHM and ITMO groups, respectively (ITHM -3.33% vs ITMO 35.4%, P < 0.01, t test) from the third week. The patient-controlled analgesia bolus change rate was lower in the ITHM group than in the ITMO group (ITHM -19.88% vs ITMO 7.79%, P < 0.01, t test) from first week. Our result shows that ITHM is noninferior to ITMO on pain relief to treat refractory cancer pain, however, at different doses and that the doses of morphine tended to increase, whereas those of hydromorphone decreased over time. Hydromorphone offers advantage over morphine in controlling BTP.",2020,"The PCA bolus change rate was lower in the ITHM group than in the ITMO group (ITHM - 19.88% vs ITMO 7.79%, P < .01, t-test) from first week.","['233 patients from 12 different pain management centers across China were enrolled, 121 and 112 in the', 'refractory cancer pain']","['hydromorphone', 'ITMO', 'ITHM', 'Hydromorphone', 'intrathecal morphine', 'intrathecal hydromorphone (ITHM) and intrathecal morphine (ITMO', 'hydromorphone vs morphine', 'intrathecal hydromorphone', 'morphine']","['PCA bolus change rate', 'pain relief', 'Clinical success', 'clinical success rate, which was defined as ratio of patients achieving ≥ 50% pain relief', 'VAS scores and BTP incidence', 'daily visual analog scale (VAS) score, breakthrough pain (BTP) incidence, intrathecal dose change and PCA bolus count change, GAD-7/PHQ-9', 'change rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0677936', 'cui_str': 'Refractory cancer'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1135120', 'cui_str': 'Breakthrough pain'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}]",233.0,0.0995406,"The PCA bolus change rate was lower in the ITHM group than in the ITMO group (ITHM - 19.88% vs ITMO 7.79%, P < .01, t-test) from first week.","[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Ma', 'Affiliation': 'Department of Pain Medicine, Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Pain Management Center, Nanjing General Hospital, Nanjing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Pain Medicine, The Affiliated Hospital of Guizhou Medical University, Guiyang, China.'}, {'ForeName': 'Zhi-Ying', 'Initials': 'ZY', 'LastName': 'Feng', 'Affiliation': 'Department of Pain Medicine, the First Affiliated Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Department of Pain Medicine, the First Affiliated Hospital, China Medical University, Heping, Shenyang, China.'}, {'ForeName': 'Xiao-Qiu', 'Initials': 'XQ', 'LastName': 'Yang', 'Affiliation': 'Department of Pain Medicine, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Fu-Qiang', 'Initials': 'FQ', 'LastName': 'Chen', 'Affiliation': 'Department of Pain Medicine, Qingdao Municipal Hospital, Qingdao, China.'}, {'ForeName': 'Bao-Lin', 'Initials': 'BL', 'LastName': 'Duan', 'Affiliation': ""Department of Pain Medicine, Qinghai Provincial People's Hospital, Xi'ning, China.""}, {'ForeName': 'You-Qing', 'Initials': 'YQ', 'LastName': 'Huang', 'Affiliation': 'Department of Pain Medicine, The 2nd Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Guang-Lun', 'Initials': 'GL', 'LastName': 'Xie', 'Affiliation': 'Department of Pain Medicine, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Hong-Guang', 'Initials': 'HG', 'LastName': 'Bao', 'Affiliation': 'Department of Pain Medicine, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmacometrics, Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jiang-Tao', 'Initials': 'JT', 'LastName': 'Xu', 'Affiliation': 'Department of Pain Medicine, Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Pain Medicine, Xijing Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yan-Qing', 'Initials': 'YQ', 'LastName': 'Liu', 'Affiliation': 'Department of Pain Medicine, Beijing Tiantan Hospital, Capital Medical University, Tiantan, Dongcheng, Beijing, China.'}]",Pain,['10.1097/j.pain.0000000000001957']
863,32570178,Effects of a 10-week multimodal dance and art intervention program leading to a public performance in persons with multiple sclerosis - A controlled pilot-trial.,"BACKGROUND


Dance therapy is increasingly reported in neurological diseases for improving several motor and cognitive functions, but was mostly studied in partner dance. No individual choreo-based dance program has ever been reported in MS.
OBJECTIVES


The aim of this pilot study is to investigate effects of a ten-week choreo-based dance intervention on different impairments in MS.
PARTICIPANTS


Seventeen participants with MS were allocated to a dance group (DG) or an art group (AG) for a ten-week intervention program, with a public live performance at the end of the intervention.
METHODS


The DG received choreo-based dance courses twice a week for 90 min, while the active control AG weekly contributed to the production by painting, music, spoken word and photo- or videography. Measurements for fatigue and fatigability, physical capacity and coordination, sensory function, cognitive capacity, quality of life and dual task performance took place before and after the intervention. Differences were analysed with Wilcoxon Signed Rank test.
RESULTS


Both groups improved significantly on executive cognitive performance during dual task and fatigue. Only the DG improved significantly on functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT). The AG showed significant improvements in on cognitive function (SDMT).
CONCLUSION


A ten-week multimodal dance intervention has positive effects on impact of fatigue, physical capacity and coordination, and cognitive performance during a dual task. Larger samples, follow-up measurements and research in different disability groups is recommended.",2020,"Only the DG improved significantly on functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT).","['persons with multiple sclerosis', 'Seventeen participants with MS']","['active control AG weekly contributed to the production by painting, music, spoken word and photo- or videography', 'ten-week choreo-based dance intervention', 'multimodal dance and art intervention program', 'dance group (DG) or an art group (AG']","['functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT', 'impact of fatigue, physical capacity and coordination, and cognitive performance', 'executive cognitive performance', 'fatigue and fatigability, physical capacity and coordination, sensory function, cognitive capacity, quality of life and dual task performance took place', 'cognitive function (SDMT']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0450331', 'cui_str': '17'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0030208', 'cui_str': 'Paintings'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231230', 'cui_str': 'Fatigability'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}]",17.0,0.0172608,"Only the DG improved significantly on functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT).","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Van Geel', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Belgium. Electronic address: fanny.vangeel@uhasselt.be.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Van Asch', 'Affiliation': 'Fit Up Neurological and Sport Physiotherapy, Antwerp, Belgium; Move to Sport Foundation, Mechelsesteenweg, Kontich, Belgium.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Veldkamp', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Belgium. Electronic address: renee.veldkamp@uhasselt.be.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Feys', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Belgium. Electronic address: peter.feys@uhasselt.be.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102256']
864,32470389,Intensity of Renal Replacement Therapy and Duration of Mechanical Ventilation: Secondary Analysis of the Acute Renal Failure Trial Network Study.,"BACKGROUND


Randomized clinical trials have failed to show benefit from increasing intensity of renal replacement therapy (RRT) for acute kidney injury, but continue to be frequently used. In addition, intensive RRT is associated with an increase in adverse events potentially secondary to small solute losses, such as phosphate. We hypothesized that, compared with less-intensive RRT, intensive RRT would lead to longer duration of mechanical ventilation.
RESEARCH QUESTION


Does more-intensive renal replacement therapy in critically ill patients with acute kidney injury increase time to extubation from mechanical ventilation when compared with less-intensive therapy?
STUDY DESIGN AND METHODS


The Acute Renal Failure Trial Network study was a randomized multicenter trial of more-intensive (hemodialysis or sustained low-efficiency dialysis six times per week or continuous venovenous hemodiafiltration at 35 mL/kg per hour) vs less-intensive (hemodialysis or sustained low-efficiency dialysis three times per week or continuous venovenous hemodiafiltration at 20 mL/kg per hour) RRT in critically ill patients with acute kidney injury. Of 1124 patients, 907 who were supported by mechanical ventilation on study initiation were included in this Cox-proportional hazards analysis. The primary outcome was the time to first successful extubation off mechanical ventilation.
RESULTS


Patients who were assigned randomly to more-intensive RRT had a 33.3% lower hazard rate of successful extubation (hazard ratio, 0.67; 95% CI, 0.52-0.88; P < .001) when compared with patients who were assigned to less-intensive RRT. Patients who were assigned to more-intensive RRT had, on average, 2.07 ventilator-free days, compared with 3.08 days in those who were assigned to less-intensive RRT (P < .001) over 14 days from start of the study.
INTERPRETATION


Critically ill mechanically ventilated patients who were assigned randomly to more-intensive RRT had longer duration of mechanical ventilation compared with those who were assigned to less-intensive RRT. The reasons for this, such as excessive phosphate loss from more-intensive RRT, deserve further study to optimize the safety and effectiveness of CRRT delivery. This was a post hoc analysis of the Acute Renal Failure Trial Network study; clinical trial registration of the original trial is NCT00076219.",2020,"RESULTS


Patients randomized to more intensive RRT had a 33.3% lower hazard rate of successful extubation (HR 0.67, 95% CI 0.52 - 0.88, P<0.001) when compared to patients randomized to less-intensive RRT.","['Of 1124 patients, 907 who were supported by mechanical ventilation on study initiation', 'critically ill patients', 'critically ill patients with AKI']","['renal replacement therapy (RRT', 'intensive (hemodialysis or sustained low-efficiency dialysis six times per week or continuous venovenous hemodiafiltration at 35 ml/kg per hour) versus less-intensive (hemodialysis or sustained low-efficiency dialysis three times per week or continuous venovenous hemodiafiltration', 'intensive RRT', 'RRT', 'Renal Replacement Therapy and Duration of Mechanical Ventilation']","['time to first successful extubation off mechanical ventilation', 'hazard rate of successful extubation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]","[{'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0472688', 'cui_str': 'Continuous venovenous hemodiafiltration'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",1124.0,0.192189,"RESULTS


Patients randomized to more intensive RRT had a 33.3% lower hazard rate of successful extubation (HR 0.67, 95% CI 0.52 - 0.88, P<0.001) when compared to patients randomized to less-intensive RRT.","[{'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Division of Nephrology, David Geffen School of Medicine at UCLA, Los Angeles, CA; Veterans Affairs, Greater Los Angeles Healthcare System, Los Angeles, CA. Electronic address: shilpasharma@mail.harvard.edu.""}, {'ForeName': 'Yvelynne P', 'Initials': 'YP', 'LastName': 'Kelly', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Palevsky', 'Affiliation': 'Renal Section, Veterans Affairs Pittsburgh Healthcare System, and the Renal-Electrolyte Division, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Sushrut S', 'Initials': 'SS', 'LastName': 'Waikar', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Section of Nephrology, Boston University School of Medicine and Boston Medical Center, Boston, MA.""}]",Chest,['10.1016/j.chest.2020.05.542']
865,32539832,"Treatment with anagliptin, a DPP-4 inhibitor, decreases FABP4 concentration in patients with type 2 diabetes mellitus at a high risk for cardiovascular disease who are receiving statin therapy.","BACKGROUND


Fatty acid-binding protein 4 (FABP4) acts as a novel adipokine, and elevated FABP4 concentration is associated with obesity, insulin resistance and atherosclerosis. Dipeptidyl peptidase-4 (DPP-4) inhibitors, a class of antidiabetic drugs, have distinct structures among the drugs, possibly leading to a drug class effect and each drug effect. Sitagliptin, a DPP-4 inhibitor, has been reported to decrease FABP4 concentration in drug-naïve and sulfonylurea-treated patients with type 2 diabetes mellitus. Anagliptin, another DPP-4 inhibitor, was shown to decrease low-density lipoprotein cholesterol (LDL-C) level to a greater extent than that by sitagliptin in the Randomized Evaluation of Anagliptin vs. Sitagliptin On low-density lipoproteiN cholesterol in diabetes (REASON) trial.
AIM AND METHODS


As a sub-analysis study using data obtained from the REASON trial, we investigated the effects of treatment with anagliptin (n = 148, male/female: 89/59) and treatment with sitagliptin (n = 159, male/female: 93/66) for 52 weeks on FABP4 concentration in patients with type 2 diabetes mellitus at a high risk for cardiovascular events who were receiving statin therapy.
RESULTS


The DPP-4 inhibitor had been administered in 82% of the patients in the anagliptin group and 81% of the patients in sitagliptin group prior to randomization. Serum FABP4 level was significantly decreased by 7.9% by treatment with anagliptin (P = 0.049) and was not significantly decreased by treatment with sitagliptin (P = 0.660). Change in FABP4 level was independently associated with basal FABP4 level and changes in waist circumference and creatinine after adjustment of age, sex and the treatment group.
CONCLUSION


Anagliptin decreases serum FABP4 concentration independent of change in hemoglobin A1c or LDL-C in patients with type 2 diabetes mellitus and dyslipidemia who are on statin therapy. Trial registration ClinicalTrials.gov number NCT02330406. Registered January 5, 2015, https://clinicaltrials.gov/ct2/show/NCT02330406.",2020,Anagliptin decreases serum FABP4 concentration independent of change in hemoglobin A1c or LDL-C in patients with type 2 diabetes mellitus and dyslipidemia who are on statin therapy.,"['patients with type 2 diabetes mellitus at a high risk for cardiovascular disease who are receiving statin therapy', 'patients with type 2 diabetes mellitus and dyslipidemia who are on statin therapy', 'n\u2009=\u2009148, male/female: 89/59) and treatment with sitagliptin (n\u2009=\u2009159, male/female: 93/66) for 52\xa0weeks on FABP4 concentration in patients with type 2 diabetes mellitus at a high risk for cardiovascular events who were receiving statin therapy', 'treated patients with type 2 diabetes mellitus']","['anagliptin, a DPP-4 inhibitor', 'Dipeptidyl peptidase-4 (DPP-4) inhibitors', 'Anagliptin vs. Sitagliptin', 'anagliptin', 'sulfonylurea']","['basal FABP4 level and changes in waist circumference and creatinine', 'serum FABP4 concentration', 'low-density lipoprotein cholesterol (LDL-C) level', 'FABP4 level', 'Serum FABP4 level', 'FABP4 concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1312689', 'cui_str': 'FABP4 protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C3272640', 'cui_str': 'anagliptin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C1312689', 'cui_str': 'FABP4 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",,0.0896455,Anagliptin decreases serum FABP4 concentration independent of change in hemoglobin A1c or LDL-C in patients with type 2 diabetes mellitus and dyslipidemia who are on statin therapy.,"[{'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Furuhashi', 'Affiliation': 'Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, South 1, West 16, Sapporo, 060-8543, Japan. furuhasi@sapmed.ac.jp.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Sakuma', 'Affiliation': 'Caress Sapporo Hokko Memorial Clinic, Sapporo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Yukimura', 'Initials': 'Y', 'LastName': 'Higashiura', 'Affiliation': 'Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, South 1, West 16, Sapporo, 060-8543, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Sakai', 'Affiliation': 'Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, South 1, West 16, Sapporo, 060-8543, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, South 1, West 16, Sapporo, 060-8543, Japan.'}, {'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Sakuma', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Shimabukuro', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nomiyama', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, International University of Health and Welfare Ichikawa Hospital, Ichikawa, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Arasaki', 'Affiliation': 'Department of Cardiology, Tomishiro Central Hospital, Tomigusuku, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Ueda', 'Affiliation': 'Department of Pharmacology and Therapeutics, University of the Ryukyus, Nishihara, Japan.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01061-0']
866,32541773,Inhaled nitric oxide therapy in acute bronchiolitis: A multicenter randomized clinical trial.,"Currently, there are no approved treatments for infants with acute bronchiolitis, the leading cause for hospitalization of infants worldwide, and thus the recommended approach is supportive. Inhaled Nitric oxide (iNO), possesses anti-viral properties, improves oxygenation, and was shown to be safe in infants with respiratory conditions. Hospitalized infants with acute bronchiolitis were therefore recruited to a prospective double-blinded, multi-center, randomized controlled pilot study. They received intermittent high dose iNO (160 ppm) plus oxygen/air for 30 min or oxygen/air alone (control), five times/day, up to 5 days. Sixty-nine infants were enrolled. No difference was observed in frequencies of subjects with at least one Adverse Event (AE) in iNO (44.1%) vs. control (55.9%); neither was Methemoglobin >7% safety threshold. No drug-related serious AEs (SAEs) were reported. Analysis of Per-Protocol population revealed that length of stay (LOS), time to SpO 2  ≥92%, and time to mTal clinical score ≤5 improved by 26.7 ± 12.7 (Welch's t-test p = 0.04), 20.8 ± 8.9 (p = 0.023), and 14.6 ± 9.1 (p = 0.118) hours, respectively, in the iNO group compared to the control. Overall, high dose iNO (160ppm) was safe, well-tolerated, reduced LOS and showed rapid improvement of oxygen saturation, compared to the standard therapy. Further investigation in larger cohorts is warranted to validate these encouraging efficacy outcomes. (Trial registration: NCT03053388).",2020,"Overall, high dose iNO (160ppm) was safe, well-tolerated, reduced LOS and showed rapid improvement of oxygen saturation, compared to the standard therapy.","['infants with acute bronchiolitis', 'Sixty-nine infants were enrolled', 'infants with respiratory conditions', 'Hospitalized infants with acute bronchiolitis', 'acute bronchiolitis']","['Inhaled nitric oxide therapy', 'Inhaled Nitric oxide (iNO', 'intermittent high dose iNO (160 ppm) plus oxygen/air for 30\u2009min or oxygen/air alone (control']","['oxygen saturation', 'safe, well-tolerated, reduced LOS', 'length of stay (LOS), time to SpO 2  ≥92%, and time to mTal clinical score']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",69.0,0.266451,"Overall, high dose iNO (160ppm) was safe, well-tolerated, reduced LOS and showed rapid improvement of oxygen saturation, compared to the standard therapy.","[{'ForeName': 'Aviv', 'Initials': 'A', 'LastName': 'Goldbart', 'Affiliation': 'Saban Pediatric Medical Center, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University, Beer Sheva, Israel. avivgold@bgu.ac.il.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Golan-Tripto', 'Affiliation': 'Saban Pediatric Medical Center, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University, Beer Sheva, Israel.'}, {'ForeName': 'Giora', 'Initials': 'G', 'LastName': 'Pillar', 'Affiliation': 'Carmel Medical Center, Haifa, Israel.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Livnat-Levanon', 'Affiliation': 'Carmel Medical Center, Haifa, Israel.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Efrati', 'Affiliation': 'Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Spiegel', 'Affiliation': 'Haemek Medical Center, Afula, Israel.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Lubetzky', 'Affiliation': ""Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Moran', 'Initials': 'M', 'LastName': 'Lavie', 'Affiliation': ""Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Carmon', 'Affiliation': 'Saban Pediatric Medical Center, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University, Beer Sheva, Israel.'}, {'ForeName': 'Abdi', 'Initials': 'A', 'LastName': 'Ghaffari', 'Affiliation': ""Department of Pathology and Molecular Medicine, Queen's University, Kingston, ON, (K7L 3N6), Canada.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Nahum', 'Affiliation': 'Saban Pediatric Medical Center, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University, Beer Sheva, Israel.'}]",Scientific reports,['10.1038/s41598-020-66433-8']
867,32541837,Anticipatory control of human gait following simulated slip exposure.,"A cautious gait (CG), marked by wider and shorter steps, is typically employed to mitigate expected perturbations proactively. However, it is not well understood if and how CG is informed by the task requirements. Therefore, we assessed how CG is adjusted to these requirements. Three groups of ten healthy young adults were exposed to a single uninterrupted protocol of treadmill walking that consisted of three distinct phases. Spatiotemporal step characteristics and margins of stability of the unperturbed strides were compared when participants were (i) only warned of a perturbation, (ii) exposed to fifty unilateral (right) slip-like perturbations and (iii) kept unaware of perturbation removal. Only the perturbation intensity predictability differed between groups. This was either kept consistent or pseudo-randomly or randomly varied. Participants walked with wider and shorter steps following the perturbation warning. However, this extinguished in continuing perturbation absence. Next, during perturbation exposure, participants shortened the step of the perturbed but increased the step of the unperturbed leg. This did not differ between groups. Finally, participants persisted in displaying CG on perturbation removal, but this extinguished over time. Collectively, we show that CG is functionally adjusted to the task requirements. These findings may have practical implications for fall-prevention training.",2020,Only the perturbation intensity predictability differed between groups.,"['participants were (i) only warned of a perturbation, (ii) exposed to fifty unilateral (right) slip-like perturbations and (iii) kept unaware of perturbation removal', 'Three groups of ten healthy young adults']",['Anticipatory control of human gait following simulated slip exposure'],['perturbation intensity predictability'],"[{'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",10.0,0.0212785,Only the perturbation intensity predictability differed between groups.,"[{'ForeName': 'Sander B', 'Initials': 'SB', 'LastName': 'Swart', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Department of Human Movement Sciences, Groningen, The Netherlands. s.b.swart@umcg.nl.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'den Otter', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Department of Human Movement Sciences, Groningen, The Netherlands.'}, {'ForeName': 'Claudine J C', 'Initials': 'CJC', 'LastName': 'Lamoth', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Department of Human Movement Sciences, Groningen, The Netherlands.'}]",Scientific reports,['10.1038/s41598-020-66305-1']
868,32541874,Abduction treatment in stable hip dysplasia does not alter the acetabular growth: results of a randomized clinical trial.,"Background The effect of bracing over natural history of stable dysplastic hips is not well known. This multicenter randomized trial aimed at objectifying the effect of abduction treatment versus active surveillance in infants of 3 to 4 months of age. Methods Patients were randomized to either Pavlik harness or active surveillance group. Ultrasound was repeated at 6 and 12 weeks post randomization. The primary outcome was the degree of dysplasia using the Graf α-angle at 6 months of age. The measurement of the acetabular index (AI) on plain pelvis X-rays was used to identify persistent dysplasia after 9 months and walking age (after 18 months). Findings The Pavlik harness group (n = 55) and active surveillance group (n = 49) were comparable for predictors of outcome. At 12 weeks follow-up the mean α-angle was 60.5° ± 3.8° in the Pavlik harness group and 60.0° ± 5.6° in the active surveillance group. (p = 0.30). Analysis of secondary outcomes (standard of care) showed no treatment differences for acetabular index at age 10 months (p = 0.82) and walking age (p = 0.35). Interpretation Pavlik harness treatment of stable but sonographic dysplastic hips has no effect on acetabular development. Eighty percent of the patients will have a normal development of the hip after twelve weeks. Therefore, we recommend observation rather than treatment for stable dysplastic hips.",2020,At 12 weeks follow-up the mean α-angle was 60.5° ± 3.8° in the Pavlik harness group and 60.0° ± 5.6° in the active surveillance group.,['infants of 3 to 4 months of age'],"['abduction treatment versus active surveillance', 'Pavlik harness or active surveillance group', 'Abduction treatment']","['acetabular growth', 'acetabular index', 'degree of dysplasia using the Graf α-angle']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C1319734', 'cui_str': 'Pavlik harness'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",,0.20056,At 12 weeks follow-up the mean α-angle was 60.5° ± 3.8° in the Pavlik harness group and 60.0° ± 5.6° in the active surveillance group.,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Pollet', 'Affiliation': ""Royal Manchester Children's hospital, Department of Pediatric Orthopedics and Traumatology, Manchester, United Kingdom. virginie.pollet@nhs.net.""}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Castelein', 'Affiliation': 'University Medical Center Utrecht, Department of Orthopedics, Utrecht, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van de Sande', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Witbreuk', 'Affiliation': 'Amsterdam Medical University Center, Amsterdam, The Netherlands.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Mostert', 'Affiliation': 'Isala Hospital, Zwolle, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Besselaar', 'Affiliation': 'Maxima Medical Center, Eindhoven, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'van Bergen', 'Affiliation': 'University Medical Center Utrecht, Department of Orthopedics, Utrecht, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Beek', 'Affiliation': 'University Medical Center Utrecht, Department of Radiology, Utrecht, The Netherlands.'}, {'ForeName': 'C S P M', 'Initials': 'CSPM', 'LastName': 'Uiterwaal', 'Affiliation': 'University Medical Center Utrecht, Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands.'}, {'ForeName': 'R J B', 'Initials': 'RJB', 'LastName': 'Sakkers', 'Affiliation': 'University Medical Center Utrecht, Department of Orthopedics, Utrecht, The Netherlands.'}]",Scientific reports,['10.1038/s41598-020-66634-1']
869,32537740,The ECG Belt for CRT response trial: Design and clinical protocol.,"The ECG Belt for CRT response trial is designed to test the hypothesis that in patients traditionally less likely to respond to cardiac resynchronization therapy (CRT), an individualized approach utilizing the electrocardiogram (ECG) Belt to guide lead placement, vector selection, and device programming is superior to current standard of care. The ECG Belt is a noninvasive mapping technology designed to measure beat by beat electrical activation of the left ventricle by utilizing unipolar measurements from multiple ECG electrodes on the body surface. The ECG Belt for CRT response trial is a multicenter, prospective, randomized, investigational pre-market research study conducted at 48 centers in the United States, Canada, and Europe and will randomize approximately 400 subjects. The trial has three arms (enrollment will be 2:1:1, respectively): utilization of the Belt to guide implant as well as postimplant programming, utilizing the Belt to guide postimplant programming alone, and a non-Belt control arm. AdaptivCRT will be an option in the treatment arm but not the control arms. The primary endpoint is change in left ventricular end-systolic volume between preimplant and at 6 months. This paper describes the design and analytic plan for the trial.",2020,The ECG Belt is a noninvasive mapping technology designed to measure beat by beat electrical activation of the left ventricle by utilizing unipolar measurements from multiple ECG electrodes on the body surface.,"['48 centers in the United States, Canada, and Europe and will randomize approximately 400 subjects']",['cardiac resynchronization therapy (CRT'],['change in left ventricular end-systolic volume'],"[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455832', 'cui_str': 'Left ventricular end-systolic cavity size'}]",,0.0379119,The ECG Belt is a noninvasive mapping technology designed to measure beat by beat electrical activation of the left ventricle by utilizing unipolar measurements from multiple ECG electrodes on the body surface.,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rickard', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Jackson', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Biffi', 'Affiliation': ""Policlinico Sant'Orsola-Malpighi, University of Bologna, Bologna, Italy.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Vernooy', 'Affiliation': 'Department of Cardiology, Maastricht Universitair Medisch Centrum, Maastricht, The Netherlands.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Bank', 'Affiliation': 'United Heart and Vascular Clinic, St Paul, Minnesota.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Cerkvenik', 'Affiliation': 'Medtronic, Plc, Fridley, Minnesota.'}, {'ForeName': 'Subham', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Medtronic, Plc, Fridley, Minnesota.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Gold', 'Affiliation': 'Department of Medicine, Division of Cardiology, Medical University of South Carolina, Charleston, South Carolina.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.13985']
870,32536177,Effect of N-acetylcysteine against Vancomycin-Induced Nephrotoxicity: A Randomized Controlled Clinical Trial.,"BACKGROUND


The proposed mechanism of vancomycin-induced nephrotoxicity (VIN) is indirect production of reactive oxygen species in the kidney tissue. This study aimed to investigate the effectiveness of N-acetylcysteine (NAC), an anti-oxidant agent, in the prevention of VIN.
METHODS


Patients who received vancomycin for any indication were randomly divided to drug (NAC) and control groups. The patients in the drug group received oral NAC 600 mg every 12 hours for 10 days, starting concurrently with vancomycin. Serum creatinine (SCr) levels and blood urea nitrogen (BUN) as well as creatinine clearance (CrCl) and 12-hour urine volume were recorded at baseline, every other day during the study, and 12 hours after the last dose of vancomycin on the 10th day. Furthermore, the cases of acute kidney injury (AKI; ≥ 0.5 mg/dL or at least 50% increase in serum creatinine from baseline) were recorded in the two groups.
RESULTS


Over the study period, 84 and 95 patients completed the study in drug and control groups, respectively. SCr and CrCl were significantly lower and higher, respectively, at all-time points (except for baseline) in the NAC compared to the control group. Furthermore, although not statistically significant, 12 cases of vancomycin-induced AKI were observed in the control group (12.63%), while 4 cases (4.76%) were reported from drug group (P = 0.066; relative risk [RR] = 0.377, 95% CI: 0.126-1.124).
CONCLUSION


NAC has the potential for reduction of VIN. However, more studies are necessary to confirm this effect.",2020,"SCr and CrCl were significantly lower and higher, respectively, at all-time points (except for baseline) in the NAC compared to the control group.","['84 and 95 patients completed the study in drug and control groups, respectively', 'Patients who received']","['N-acetylcysteine (NAC', 'vancomycin', 'N-acetylcysteine against Vancomycin-Induced Nephrotoxicity', 'oral NAC', 'drug (NAC', 'NAC', 'vancomycin-induced nephrotoxicity (VIN']","['Serum creatinine (SCr) levels and blood urea nitrogen (BUN) as well as creatinine clearance (CrCl) and 12-hour urine volume', 'serum creatinine', 'SCr and CrCl', 'vancomycin-induced AKI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]",,0.0396664,"SCr and CrCl were significantly lower and higher, respectively, at all-time points (except for baseline) in the NAC compared to the control group.","[{'ForeName': 'Shirinsadat', 'Initials': 'S', 'LastName': 'Badri', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Rasool', 'Initials': 'R', 'LastName': 'Soltani', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Sayadi', 'Affiliation': 'Students Research Committee, Faculty of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Khorvash', 'Affiliation': 'Department of Infectious Diseases, Faculty of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Meidani', 'Affiliation': 'Department of Infectious Diseases, Faculty of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Taheri', 'Affiliation': 'Isfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Archives of Iranian medicine,['10.34172/aim.2020.33']
871,32558989,"Effects of danicamtiv, a novel cardiac myosin activator, in heart failure with reduced ejection fraction: experimental data and clinical results from a phase 2a trial.","AIMS


Both left ventricular (LV) and left atrial (LA) dysfunction and remodelling contribute to adverse outcomes in heart failure with reduced ejection fraction (HFrEF). Danicamtiv is a novel, cardiac myosin activator that enhances cardiomyocyte contraction.
METHODS AND RESULTS


We studied the effects of danicamtiv on LV and LA function in non-clinical studies (ex vivo: skinned muscle fibres and myofibrils; in vivo: dogs with heart failure) and in a randomized, double-blind, single- and multiple-dose phase 2a trial in patients with stable HFrEF (placebo, n = 10; danicamtiv, n = 30; 50-100 mg twice daily for 7 days). Danicamtiv increased ATPase activity and calcium sensitivity in LV and LA myofibrils/muscle fibres. In dogs with heart failure, danicamtiv improved LV stroke volume (+10.6 mL, P < 0.05) and LA emptying fraction (+10.7%, P < 0.05). In patients with HFrEF (mean age 60 years, 25% women, ischaemic heart disease 48%, mean LV ejection fraction 32%), treatment-emergent adverse events, mostly mild, were reported in 17 patients (57%) receiving danicamtiv and 4 patients (40%) receiving placebo. Danicamtiv (at plasma concentrations ≥2000 ng/mL) increased stroke volume (up to +7.8 mL, P < 0.01), improved global longitudinal (up to -1.0%, P < 0.05) and circumferential strain (up to -3.3%, P < 0.01), decreased LA minimal volume index (up to -2.4 mL/m 2  , P < 0.01) and increased LA function index (up to 6.1, P < 0.01), when compared with placebo.
CONCLUSIONS


Danicamtiv was well tolerated and improved LV systolic function in patients with HFrEF. A marked improvement in LA volume and function was also observed in patients with HFrEF, consistent with pre-clinical findings of direct activation of LA contractility.",2020,"In dogs with heart failure, danicamtiv improved LV stroke volume (+10.6 mL; p<0.05) and LA emptying fraction (+10.7%, p<0.05).","['heart failure with reduced ejection fraction', 'heart failure with reduced ejection fraction (HFrEF', 'vivo: dogs with heart failure', 'patients with stable', 'patients with HFrEF']","['danicamtiv, a novel cardiac myosin activator', 'HFrEF (placebo', 'placebo']","['circumferential strain', 'LA function index', 'LA volume and function', 'stroke volume', 'tolerated and improved LV systolic function', 'LV and LA function', 'LA minimal volume index', 'LA emptying fraction', 'LV stroke volume', 'global longitudinal', 'ATPase activity and calcium sensitivity']","[{'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0949656', 'cui_str': 'Cardiac Myosin'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0078995', 'cui_str': 'Left Atrial Function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0001473', 'cui_str': 'Adenosinetriphosphatase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.144767,"In dogs with heart failure, danicamtiv improved LV stroke volume (+10.6 mL; p<0.05) and LA emptying fraction (+10.7%, p<0.05).","[{'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Tamby', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Cleland', 'Affiliation': 'Robertson Centre for Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koren', 'Affiliation': 'Jacksonville Center for Clinical Research, Jacksonville, FL, USA.'}, {'ForeName': 'Leslie B', 'Initials': 'LB', 'LastName': 'Forgosh', 'Affiliation': 'HealthEast Heart Care, Saint Paul, MN, USA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Tennova Healthcare-Harton, Tullahoma, TN, USA.'}, {'ForeName': 'Lars H', 'Initials': 'LH', 'LastName': 'Lund', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Camacho', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Karra', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Henk P', 'Initials': 'HP', 'LastName': 'Swart', 'Affiliation': 'Antonius Ziekenhuis Sneek, Sneek, The Netherlands.'}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Pellicori', 'Affiliation': 'Robertson Centre for Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wagner', 'Affiliation': 'Charité Research Organization, Berlin, Germany.'}, {'ForeName': 'Ray E', 'Initials': 'RE', 'LastName': 'Hershberger', 'Affiliation': 'Divisions of Human Genetics and Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Narayana', 'Initials': 'N', 'LastName': 'Prasad', 'Affiliation': ""Cardiovascular Imaging Core Laboratory, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Anto', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Kaylyn', 'Initials': 'K', 'LastName': 'Bell', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Edelberg', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Henze', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Kurio', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Wanying', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Wells', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Sam L', 'Initials': 'SL', 'LastName': 'Teichman', 'Affiliation': 'Teichman Drug Development Consulting, Oakland, CA, USA.'}, {'ForeName': 'Carlos L', 'Initials': 'CL', 'LastName': 'Del Rio', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",European journal of heart failure,['10.1002/ejhf.1933']
872,32553411,Usefulness of the alpha maneuver in the peritoneal catheter displacement: review and experience.,"INTRODUCTION AND OBJECTIVES


Peritoneal catheter displacement is one of the most common complications of peritoneal dialysis. The alpha manoeuvre has been proposed as a repositioning technique, which involves returning the catheter to its correct position using rigid guidewires under fluoroscopic guidance. The aim of this study is to analyse the 107 procedures performed at our Centre to identify factors that may predict the success of the technique.
MATERIAL AND METHODS


The alpha manoeuvre method was used in 86 patients, with a total of 107 procedures (70 patients underwent one manoeuvre only, 16 patients underwent two or more manoeuvres).
RESULTS


The overall success rate of the technique was 60%. There were no differences in success rate in terms of gender (60% male vs. 40% female, p = 0.104), time of catheter failure (early 60% vs. late 62%, p = 0.849), type of catheter (75% self-locating vs. 58% spiral, p = 0.633) or the initial position of the catheter. There was only one case of peritonitis related to the procedure.
CONCLUSIONS


The alpha manoeuvre is an effective and safe method for correcting peritoneal catheter displacement.",2020,"There were no differences in success rate in terms of gender (60% male vs. 40% female, p = 0.104), time of catheter failure (early 60% vs. late 62%, p = 0.849), type of catheter (75% self-locating vs. 58% spiral, p = 0.633) or the initial position of the catheter.","['86 patients, with a total of 107 procedures (70 patients underwent one manoeuvre only, 16 patients underwent two or more manoeuvres']",[],"['time of catheter failure', 'success rate', 'overall success rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",16.0,0.0223798,"There were no differences in success rate in terms of gender (60% male vs. 40% female, p = 0.104), time of catheter failure (early 60% vs. late 62%, p = 0.849), type of catheter (75% self-locating vs. 58% spiral, p = 0.633) or the initial position of the catheter.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Del Río García', 'Affiliation': 'Hospital San Agustín, Avilés, España. Electronic address: lauri_rio@hotmail.com.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Merino Bueno', 'Affiliation': 'Hospital de Cabueñes, Gijón, España.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Alcuria Ledo', 'Affiliation': 'Hospital San Agustín, Avilés, España.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Álvarez Santamarta', 'Affiliation': 'Hospital Universitario Central de Asturias, Oviedo, España.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Rodríguez Suárez', 'Affiliation': 'Hospital Universitario Central de Asturias, Oviedo, España.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Sánchez Álvarez', 'Affiliation': 'Hospital de Cabueñes, Gijón, España.'}]",Nefrologia : publicacion oficial de la Sociedad Espanola Nefrologia,['10.1016/j.nefro.2020.03.006']
873,32560724,"Effect of saroglitazar 2 mg and 4 mg on glycemic control, lipid profile and cardiovascular disease risk in patients with type 2 diabetes mellitus: a 56-week, randomized, double blind, phase 3 study (PRESS XII study).","BACKGROUND


The potential for PPAR agonists to positively affect risk of cardiovascular disease in patients with type 2 diabetes (T2DM) is of persistent attention. The PRESS XII study primarily aimed to evaluate the efficacy and safety of saroglitazar (2 mg and 4 mg) as compared to pioglitazone 30 mg on glycemic control in patients with type 2 diabetes mellitus.
METHODS


In this randomized double-blind study, patients with T2DM [glycosylated hemoglobin (HbA1c) ≥ 7.5%] were enrolled from 39 sites in India. Patients received once-daily doses of either saroglitazar or pioglitazone (1:1:1 allocation ratio) for a total of 24 weeks. Patients were continued in a double blind extension period for an additional 32 weeks. Efficacy evaluations of glycemic parameters [HbA1c (Primary endpoint at week 24), FPG and PPG] and other lipid parameters (TG, LDL-C, VLDL-C, HDL-C, TC, Non HDL-C, Apo A1 and Apo B) were conducted at week 12, 24 and 56 and compared to the baseline levels. The efficacy analyses were performed by using paired t-test and ANCOVA model.
RESULTS


A total of 1155 patients were enrolled in this study. The baseline characteristics were similar between the three treatment groups. The within group mean (± SD) change in HbA1c (%) from baseline of the saroglitazar (2 mg and 4 mg) and pioglitazone treatment groups at week 24 were: - 1.38 ± 1.99 for saroglitazar 2 mg; - 1.47 ± 1.92 for saroglitazar 4 mg and - 1.41 ± 1.86 for pioglitazone, respectively. Statistically significant reduction from baseline in HbA1c was observed in each treatment group at week 24 with p-value < 0.016. There was a significant reduction in TG, LDL-C, VLDL-C, TC and Non HDL-C with a significant increase in HDL-C from baseline levels (< 0.016). Most of the AE's were 'mild' to 'moderate' in severity and were resolved by the completion of the study.
CONCLUSIONS


Saroglitazar effectively improved glycemic control and lipid parameters over 56 weeks in patients of T2DM receiving background metformin therapy and has a promising potential to reduce the cardiovascular risk in T2DM patients. Trial registration CTRI/2015/09/006203, dated 22/09/2015.",2020,"There was a significant reduction in TG, LDL-C, VLDL-C, TC and Non HDL-C with a significant increase in HDL-C from baseline levels (< 0.016).","['patients with type 2 diabetes mellitus', 'patients with T2DM [glycosylated hemoglobin (HbA1c)\u2009≥\u20097.5%] were enrolled from 39 sites in India', 'patients with type 2 diabetes (T2DM', 'A total of 1155 patients were enrolled in this study', 'T2DM patients']","['pioglitazone', 'saroglitazar or pioglitazone', 'saroglitazar 2\xa0mg and 4\xa0mg', 'saroglitazar']","['FPG and PPG] and other lipid parameters (TG, LDL-C, VLDL-C, HDL-C, TC, Non HDL-C, Apo A1 and Apo B', 'cardiovascular risk', 'TG, LDL-C, VLDL-C, TC and Non HDL-C', 'glycemic control, lipid profile and cardiovascular disease risk', 'glycemic control and lipid parameters', 'HDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}]","[{'cui': 'C0049716', 'cui_str': ""6-thioguanosine 5'-diphosphate""}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1155.0,0.113944,"There was a significant reduction in TG, LDL-C, VLDL-C, TC and Non HDL-C with a significant increase in HDL-C from baseline levels (< 0.016).","[{'ForeName': 'Manjunath', 'Initials': 'M', 'LastName': 'Krishnappa', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India. manjunath.k@zyduscadila.com.'}, {'ForeName': 'Kishor', 'Initials': 'K', 'LastName': 'Patil', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Krupi', 'Initials': 'K', 'LastName': 'Parmar', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Purav', 'Initials': 'P', 'LastName': 'Trivedi', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Nirali', 'Initials': 'N', 'LastName': 'Mody', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Chintan', 'Initials': 'C', 'LastName': 'Shah', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Khushboo', 'Initials': 'K', 'LastName': 'Faldu', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Maroo', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Deven', 'Initials': 'D', 'LastName': 'Parmar', 'Affiliation': 'Zydus Discovery DMCC, Dubai, UAE.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01073-w']
874,32566980,Partial resection of the infrapatellar fat pad during anterior cruciate ligament reconstruction has no effect on clinical outcomes including anterior knee pain.,"BACKGROUND


Anterior knee pain (AKP) is a major complication that occurs after anterior cruciate ligament reconstruction (ACLR), even when hamstring tendon (HT) grafts are used. Damage to the infrapatellar fat pad (IPFP) during arthroscopy can cause AKP. The purpose of this study was to evaluate the influence of IPFP preservation on clinical outcomes, including AKP, in patients who underwent ACLR with HT autografts using the inside-out technique.
METHODS


Forty-two patients who underwent primary ACLR with HT autografts were prospectively assessed for 2 years after surgery. They were randomly selected to undergo treatment with as much intercondylar IPFP preservation as possible or with intercondylar IPFP resection to confirm the ACL origin on the femoral and tibial sides, especially the femoral footprint in deep flexion of the knee joint. The total IPFP volume was calculated using sagittal MR images before and 6 months after surgery. The patients completed a subjective knee score questionnaire and were assessed for patellar tendon tenderness and pain with the half-squat test or single-leg hop test at 6 months and 2 years postoperatively.
RESULTS


There were no differences in the patient characteristics, including age, sex, BMI, time from injury to surgery, and meniscus tear. The difference in the total size of the IPFP preserved was significant (P = 0.004). However, there were no significant differences in the subjective knee scores. Moreover, there were no differences in the clinical assessment parameters between the IPFP preservation and resection groups.
CONCLUSIONS


The size of the IPFP decreased more in the resection group than in the preservation group at 6 months after surgery. However, partial IPFP resection, which was used to better visualize the origin of the ACL, had no effect on the clinical outcomes, including AKP.
LEVEL OF EVIDENCE


Level II.",2020,The difference in the total size of the IPFP preserved was significant (P = 0.004).,"['Forty-two patients who underwent primary ACLR with HT autografts were prospectively assessed for 2\xa0years after surgery', 'patients who underwent ACLR with HT autografts using the inside-out technique', 'anterior knee pain']","['IPFP', 'intercondylar IPFP preservation as possible or with intercondylar IPFP resection to confirm the ACL origin', 'anterior cruciate ligament reconstruction (ACLR', 'anterior cruciate ligament reconstruction']","['total IPFP volume', 'size of the IPFP', 'subjective knee score questionnaire', 'subjective knee scores', 'patellar tendon tenderness and pain', 'total size of the IPFP']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain'}]","[{'cui': 'C0224706', 'cui_str': 'Structure of infrapatellar fat pad'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0224706', 'cui_str': 'Structure of infrapatellar fat pad'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",42.0,0.0175713,The difference in the total size of the IPFP preserved was significant (P = 0.004).,"[{'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Asai', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8641, Japan.'}, {'ForeName': 'Junsuke', 'Initials': 'J', 'LastName': 'Nakase', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8641, Japan. nakase1007@yahoo.co.jp.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Oshima', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8641, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Shimozaki', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8641, Japan.'}, {'ForeName': 'Rikuto', 'Initials': 'R', 'LastName': 'Yoshimizu', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8641, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8641, Japan.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03520-5']
875,32564093,"Effects of progesterone therapy on serum sclerostin levels in healthy menopausal women: a 3-month randomized, placebo-controlled clinical trial.","Sclerostin, a natural hormone made in bone, suppresses bone formation. Sclerostin is also decreased by estrogen. Progesterone, estrogen's menstrual partner, stimulates bone formation. It is unclear whether progesterone influences sclerostin. This study showed that progesterone did not change sclerostin using serum remaining from a randomized progesterone hot flush therapy trial.
INTRODUCTION


Progesterone and sclerostin are both endogenous hormones acting through osteoblast-origin cells and promote or suppress bone formation, respectively. Estradiol suppresses sclerostin, but progesterone, its menstrual cycle partner hormone, has unclear sclerostin relationships. We postulated that progesterone therapy would influence serum sclerostin levels.
METHODS


We obtained sclerostin levels for an ethics-approved post hoc analysis. Fasting sclerostin was measured in all remaining sera from a previous 12-week randomized controlled trial (RCT) of oral micronized progesterone (progesterone) for menopausal (> 1 year after last flow) vasomotor symptoms (VMS). Women in the RCT took 300 mg progesterone at bedtime or placebo (1:1) in a trial showing progesterone significantly decreased VMS.
RESULTS


Participants were healthy menopausal, primarily Caucasian (91.2%) community-dwelling women (± SD), 55.2 ± 4.6 years old with BMI 24.9 ± 2.9 kg/m 2 . The baseline sclerostin level in 60 women was 28.41 ± 10.47 pmol/L. Baseline sclerostin was not correlated with the run-in VMS score (r = 0.143, P = 0.294). Paired baseline and 12-week RCT data for 52 women showed serum sclerostin levels did not change related to experimental therapy (P = 0.504). Changes in final sclerostin values adjusted for baseline were progesterone (- 1.07 ± 7.96 pmol/L) and placebo (- 2.64 ± 8.70 pmol/L). In observational data (n = 60), baseline sclerostin levels correlated with the General Framingham Cardiovascular (CVD) Risk score (r = - 0.398, P = 0.003) and self-reported health by SF-36 quality of life instrument (QoL, r = - 0.331, P = 0.016).
CONCLUSION


Physiological oral micronized progesterone did not stimulate nor suppress serum sclerostin levels based on post hoc analysis of RCT data. Exploratory results, however, showed sclerostin negatively correlated with CVD risk and QoL. ClinicalTrials.gov #NCT0146469.",2020,Physiological oral micronized progesterone did not stimulate nor suppress serum sclerostin levels based on post hoc analysis of RCT data.,"['Participants were healthy menopausal, primarily Caucasian (91.2%) community-dwelling women (±\u2009SD), 55.2\u2009±\u20094.6\xa0years old with BMI 24.9\u2009±\u20092.9\xa0kg/m 2 ', 'healthy menopausal women']","['oral micronized progesterone (progesterone', 'progesterone', 'progesterone therapy', 'Physiological oral micronized progesterone', 'placebo']","['baseline sclerostin levels', 'final sclerostin values', 'General Framingham Cardiovascular (CVD) Risk score', 'Fasting sclerostin', 'serum sclerostin levels', ""Progesterone, estrogen's menstrual partner, stimulates bone formation"", 'baseline sclerostin level', 'VMS']","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517641', 'cui_str': '2.9'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0279495', 'cui_str': 'Progestogen hormone therapy'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",60.0,0.0755792,Physiological oral micronized progesterone did not stimulate nor suppress serum sclerostin levels based on post hoc analysis of RCT data.,"[{'ForeName': 'Y B', 'Initials': 'YB', 'LastName': 'Yang', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Centre for Menstrual Cycle and Ovulation Research (CeMCOR), University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goshtasebi', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Centre for Menstrual Cycle and Ovulation Research (CeMCOR), University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'van Lierop', 'Affiliation': 'Center for Bone Quality, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kalidasan', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Centre for Menstrual Cycle and Ovulation Research (CeMCOR), University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Hitchcock', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Centre for Menstrual Cycle and Ovulation Research (CeMCOR), University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Prior', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Centre for Menstrual Cycle and Ovulation Research (CeMCOR), University of British Columbia, Vancouver, British Columbia, Canada. Jerilynn.prior@ubc.ca.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05505-x']
876,32569395,Fast effectiveness of a solubilized low-dose budesonide nasal spray in allergic rhinitis.,"BACKGROUND


Budesonide, a poorly water-soluble corticosteroid, is currently marketed as a suspension. Budesolv is a novel aqueous formulation containing dissolved budesonide showing increased local availability in preclinical models. Budesolv contains ~85% less corticosteroid than the marketed comparator.
OBJECTIVE


The study (EudraCT:2018-001324-19) was designed to assess non-inferiority of Budesolv compared to Rhinocort® Aqua 64 (RA) and early onset of action.
METHODS


In a three-way cross-over double-blinded randomized trial, Budesolv 10 was compared to RA and placebo in grass pollen allergic rhinoconjunctivitis volunteers (n = 83 (ITT); n = 75 (PP)). On day 1, participants entered the Vienna Challenge Chamber (VCC) for 6 hours; first treatment took place at 1:45 hours after entry. Participants treated themselves for further 6 days; on day 8, the last treatment was applied before entering the VCC. Subjective symptom scores, nasal airflow and nasal secretion were measured regularly during allergen challenge.
RESULTS


Budesolv 10 was equally effective compared to RA with respect to TNSS and nasal airflow after eight days of treatment with a strongly reduced dose (more than 80% reduction). After first dose, only Budesolv 10 showed a significant reduction of nasal and respiratory symptoms starting 90 minutes (P < .05) and 15 minutes (P < .05) after application onwards, respectively, demonstrating an early onset of efficacy. A clinically significant 1 point reduction in nasal symptom score was reached at 195 minutes (P < .05) after application.
CONCLUSIONS AND CLINICAL RELEVANCE


The novel preservative-free, aqueous low-dose budesonide formulation is highly efficacious even after an initial single treatment. Thus, Budesolv 10 appears to be an effective acute treatment for allergic rhinitis as well as for AR comorbidities like mild asthma and conjunctivitis.",2020,"A clinically significant 1 point reduction in nasal symptom score was reached at 195 minutes (p<0.05) after application.
","['allergic rhinitis', 'grass pollen allergic rhinoconjunctivitis volunteers (n=83 (ITT); n=75 (PP']","['Budesonide', 'RA and placebo', 'solubilized low-dose budesonide nasal spray']","['TNSS and nasal airflow', 'Subjective symptom scores, nasal airflow and nasal secretion', 'nasal symptom score', 'nasal and respiratory symptoms']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0440307', 'cui_str': 'grass pollen'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0678163', 'cui_str': 'Rhinocort'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1245189', 'cui_str': 'Budesonide Nasal Spray'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}]",,0.0434773,"A clinically significant 1 point reduction in nasal symptom score was reached at 195 minutes (p<0.05) after application.
","[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Schmutz', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lemell', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Unger-Manhart', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Nakowitsch', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goessl', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Savli', 'Affiliation': 'Biostatistik & Consulting, Hartberg, Austria.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Prieschl-Grassauer', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13691']
877,32576901,An optimized test bolus for computed tomography pulmonary angiography and its application at 80 kV with 10 ml contrast agent.,"Computed tomography pulmonary angiography (CTPA) is usually used for pulmonary embolism (PE) detection. However, the determination of scan timing remains a challenge due to the short scan duration of CTPA. We aimed to develop an optimized test bolus to determine scan delay in CTPA. The time-enhancement curves were obtained by measuring the enhancement within a region of interest in the main pulmonary artery and vein. A total of 70 patients were randomly divided into two groups (n = 35 each): the control group underwent CTPA using the test bolus approach and the test group underwent CTPA using the biphasic time-enhancement curves approach. Tube voltages of 100 kVp and 80 kVp and 20 ml and 10 ml contrast agent were adopted in the control and test groups, respectively. The CT numbers, image quality, PE detection was evaluated. There was a point of intersection between the pulmonary artery and vein test bolus enhancement curves. The scan delay time (T DELAY ) was obtained based on the time at intersection (T CROSS ) and the scan duration (T SD ): T DELAY  = T CROSS  - T SD . The mean CT numbers for pulmonary vein in the control were higher than those in the test group (all p < 0.001). The image quality for the pulmonary arteries in the test group was better than that in the control group (p < 0.01), with artifact reduction in the superior vena cava. Segmental PE could be detected using the optimized protocol. The radiation dose and iodine load in the test group were all lower than those in the control (p < 0.01). We established an approach to calculate the scan delay of CTPA, and this approach could be used for CTPA at 80 kVp with 10 ml contrast agent.",2020,"The image quality for the pulmonary arteries in the test group was better than that in the control group (p < 0.01), with artifact reduction in the superior vena cava.",['A total of 70 patients'],"['control group underwent CTPA', 'Tube voltages of 100 kVp and 80 kVp and 20', 'Computed tomography pulmonary angiography (CTPA', 'CTPA']","['image quality for the pulmonary arteries', 'mean CT numbers for pulmonary vein', 'time-enhancement curves', 'radiation dose and iodine load', 'CT numbers, image quality, PE detection', 'scan delay time (T DELAY ']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0677490', 'cui_str': 'Angiogram pulmonary'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary artery structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}]",70.0,0.0231022,"The image quality for the pulmonary arteries in the test group was better than that in the control group (p < 0.01), with artifact reduction in the superior vena cava.","[{'ForeName': 'Huiming', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Radiology, the Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, the Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiology, the Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Qin', 'Affiliation': 'Department of Radiology, the Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Radiology, the Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Zhaochun', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Department of Radiology, the Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Zhongqiu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, the Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China. zhqwang001@126.com.'}]",Scientific reports,['10.1038/s41598-020-67145-9']
878,32574587,"Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11 years old with severe atopic dermatitis: A randomized, double-blinded, placebo-controlled phase 3 trial.","BACKGROUND


Children with severe atopic dermatitis (AD) have limited treatment options.
OBJECTIVE


We report the efficacy and safety of dupilumab + topical corticosteroids (TCS) in children aged 6-11 years with severe AD inadequately controlled with topical therapies.
METHODS


In this double-blind, 16-week, phase 3 trial (NCT03345914), 367 patients were randomized 1:1:1 to 300 mg dupilumab every 4 weeks (300 mg q4w), a weight-based regimen of dupilumab every 2 weeks (100 mg q2w, baseline weight <30 kg; 200 mg q2w, baseline weight ≥30 kg), or placebo; with concomitant medium-potency TCS.
RESULTS


Both the q4w and q2w dupilumab + TCS regimens resulted in clinically meaningful and statistically significant improvement in signs, symptoms, and quality of life (QOL) versus placebo + TCS in all prespecified endpoints. For q4w, q2w, and placebo, 32.8%, 29.5%, and 11.4% of patients, respectively, achieved Investigator's Global Assessment scores of 0 or 1; 69.7%, 67.2%, and 26.8% achieved ≥75% improvement in Eczema Area and Severity Index scores; and 50.8%, 58.3%, and 12.3% achieved ≥4-point reduction in worst itch score. Response to therapy was weight-dependent: optimal dupilumab doses for efficacy and safety were 300 mg q4w in children <30 kg and 200 mg q2w in children ≥30 kg. Conjunctivitis and injection-site reactions were more common with dupilumab + TCS than with placebo + TCS.
LIMITATIONS


Short-term 16-week treatment period; severe AD only.
CONCLUSION


Dupilumab + TCS is efficacious and well tolerated in children with severe AD, significantly improving signs, symptoms, and QOL.",2020,"Both the q4w and q2w dupilumab+TCS regimens resulted in clinically meaningful and statistically significant improvement in signs, symptoms, and quality of life (QoL) versus placebo+TCS in all prespecified endpoints.","['children aged 6-11 years with severe AD inadequately controlled with topical therapies', 'Children with severe atopic dermatitis (AD', '367 patients', 'children with severe AD', 'children 6 to 11 years old with severe atopic dermatitis']","['Dupilumab+TCS', 'dupilumab with concomitant topical corticosteroids', 'placebo; with concomitant medium-potency TCS', 'dupilumab+TCS', 'dupilumab + topical corticosteroids (TCS', 'placebo']","['signs, symptoms, and quality of life (QoL', 'Eczema Area and Severity Index scores', 'Efficacy and safety', 'efficacy and safety', 'Conjunctivitis and injection-site reactions', ""Investigator's Global Assessment scores""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}]","[{'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",367.0,0.54447,"Both the q4w and q2w dupilumab+TCS regimens resulted in clinically meaningful and statistically significant improvement in signs, symptoms, and quality of life (QoL) versus placebo+TCS in all prespecified endpoints.","[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Paller', 'Affiliation': ""Northwestern University Feinberg School of Medicine, Chicago, Illinois; Ann and Robert H. Lurie Children's Hospital, Chicago, Illinois.""}, {'ForeName': 'Elaine C', 'Initials': 'EC', 'LastName': 'Siegfried', 'Affiliation': ""Saint Louis University, St. Louis, Missouri; Cardinal Glennon Children's Hospital, St. Louis, Missouri.""}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Ludwig-Maximilian University, Munich, Germany.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Cork', 'Affiliation': 'University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Arkwright', 'Affiliation': 'Lydia Becker Institute of Immunology and Inflammation, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': ""Probity Medical Research, Peterborough, Ontario, Canada; SKiN Centre for Dermatology, Peterborough, Ontario, Canada; Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Beck', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Boguniewicz', 'Affiliation': 'National Jewish Health, Denver, Colorado; University of Colorado School of Medicine, Denver, Colorado.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Sher', 'Affiliation': 'Peninsula Research Associates, Rolling Hills Estates.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Weisman', 'Affiliation': 'Advanced Medical Research, PC, Atlanta, California.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': ""O'Malley"", 'Affiliation': 'Sanofi, Cambridge, Massachusetts.'}, {'ForeName': 'Naimish', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Sanofi, Cambridge, Massachusetts.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hardin', 'Affiliation': 'Sanofi, Cambridge, Massachusetts.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Davis', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Kamal', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'Faisal A', 'Initials': 'FA', 'LastName': 'Khokhar', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Weinreich', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Beazley', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Shumel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York. Electronic address: Brad.shumel@regeneron.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.06.054']
879,32482534,"""Decision for adjuvant treatment in stage II colon cancer based on circulating tumor DNA:The CIRCULATE-PRODIGE 70 trial"".","BACKGROUND


Adjuvant treatment for stage II colon cancer remains debated. Finding a tool to select patients at risk for disease recurrence may help the clinical decision. Circulating tumor DNA (ctDNA) has been reported recently as a potential predictive marker for disease recurrence. We thus aim to test its ability to better select stage II colon cancer patients for adjuvant therapy.
METHODS


This national, phase III trial (NCT00002019-000935-15) conducted in more than 100 centers in France, plans to screen around 2640 patients in order to randomize (2:1; minimization method) 198 ctDNA positive patients. Patients aged 18 to 75 years with ECOG performance status ≤1 with R0 surgical resection of a pT3-T4aN0 colon or high rectum adenocarcinoma will be randomized within 63 days after curative-intent surgery, to adjuvant mFOLFOX6 (oxaliplatin 85 mg/m², leucovorin 400 mg/m², and 5-FU bolus 400 mg/m2 then 5FU Continuous infusion 2.4 g/m²) every two weeks for 12 cycles or observation. Patients will be followed for maximum 7 years. A gain of 17.5% in 3-yr disease free survival (DFS) is expected (42.5% in the experimental arm vs. 25% in the control arm; HR:0.62; α, 5% [two-sided log-rank test]; 1-β, 80%). Secondary endpoints include 2-yr DFS, overall survival, and toxicity. Recruitement began End of January 2020.",2020,"A gain of 17.5% in 3-yr disease free survival (DFS) is expected (42.5% in the experimental arm vs. 25% in the control arm; HR:0.62; α, 5% [two-sided log-rank test];","['Patients aged 18 to 75 years with ECOG performance status ≤1 with R0 surgical resection of a pT3-T4aN0 colon or high rectum adenocarcinoma', '000935-15) conducted in more than 100 centers in France, plans to screen around 2640 patients in order to randomize (2:1; minimization method) 198 ctDNA positive patients', 'stage II colon cancer', 'stage II colon cancer patients for adjuvant therapy', 'stage II colon cancer based on circulating tumor DNA']","['curative-intent surgery, to adjuvant mFOLFOX6 (oxaliplatin 85 mg/m², leucovorin 400 mg/m², and 5-FU bolus 400 mg/m2 then 5FU Continuous infusion 2.4 g/m²']","['survival (DFS', '2-yr DFS, overall survival, and toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332393', 'cui_str': 'pT3 category'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278479', 'cui_str': 'Carcinoma of colon, stage II'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C4517631', 'cui_str': '2.4'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.265571,"A gain of 17.5% in 3-yr disease free survival (DFS) is expected (42.5% in the experimental arm vs. 25% in the control arm; HR:0.62; α, 5% [two-sided log-rank test];","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taïeb', 'Affiliation': 'Department of gastroenterology and GI Oncology, Georges-Pompidou European Hospital, AP-HP; Sorbonne Paris cité, Université de Paris, Paris, France. Electronic address: jtaieb75@gmail.com.'}, {'ForeName': 'Léonor', 'Initials': 'L', 'LastName': 'Benhaim', 'Affiliation': 'Département de chirurgie viscérale oncologique, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Laurent Puig', 'Affiliation': 'Pole biologie, Hospital European George Pompidou, Paris, Île-de-France, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Le Malicot', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive; EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France.'}, {'ForeName': 'Jean François', 'Initials': 'JF', 'LastName': 'Emile', 'Affiliation': 'EA4340, Ambroise Pare Hospital, Beuvry, Hauts-de-France, France.'}, {'ForeName': 'Flore', 'Initials': 'F', 'LastName': 'Geillon', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive; EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tougeron', 'Affiliation': 'Gastroenterology Department and Medical Oncology Department, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Manfredi', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive; EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France; Centre de Recherche des Cordeliers, INSERM, CNRS, Sorbonne Université, USPC, Université de Paris, Equipe labellisée Ligue Nationale contre le cancer, Paris, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Chauvenet', 'Affiliation': 'Department of Gastroenterology, Groupement hospitalier Sud, Hospices civils de Lyon, Pierre Bénite, France.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Taly', 'Affiliation': 'Centre de Recherche des Cordeliers, INSERM, CNRS, Sorbonne Université, USPC, Université de Paris, Equipe labellisée Ligue Nationale contre le cancer, Paris, France.'}, {'ForeName': 'Côme', 'Initials': 'C', 'LastName': 'Lepage', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive; EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France; Department of digestive oncology University hospital Dijon; University of Burgundy and Franche Comté, Dijon, France; Centre de Recherche des Cordeliers, INSERM, CNRS, Sorbonne Université, USPC, Université de Paris, Equipe labellisée Ligue Nationale contre le cancer, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'André', 'Affiliation': 'Sorbonne Université and Hôpital Saint Antoine, Paris, France.'}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2020.04.010']
880,32548702,"Association of diabetes-related autoantibodies with the incidence of asthma, eczema and allergic rhinitis in the TRIGR randomised clinical trial.","AIMS/HYPOTHESIS


This paper presents the relationship between islet autoantibodies, precursors of type 1 diabetes, and the development of persistent asthma, allergic rhinitis and atopic eczema.
METHODS


A total of 2159 newborns who had a first-degree relative with type 1 diabetes and selected HLA genotypes were followed until the youngest participant reached 10 years of age. Islet cell antibodies (ICA) were detected using indirect immunofluorescence. Autoantibodies to insulin (IAA), GAD (GADA), the tyrosine phosphatase-related insulinoma-associated 2 molecule (IA-2A) and zinc transporter 8 (ZnT8A) were quantified with the use of specific radiobinding assays. As an ancillary study, the incidence of asthma, allergic rhinitis and eczema was assessed in 1106 of these children using the International Study of Asthma and Allergies in Childhood (ISAAC) core questionnaire when the children were 9-11 years old. HRs with 95% CIs were calculated to depict the incidence of these diseases following seroconversion to autoantibody positivity.
RESULTS


The cumulative incidence of atopic eczema, allergic rhinitis and persistent asthma were 22%, 9% and 7.5%, respectively, by 9-11 years of age. The occurrence of diabetes-related autoantibodies showed a protective association with subsequently reported incidence of asthma and eczema. The incidence of rhinitis was not significantly related to the occurrence of IAA or GADA (statistical power was limited), but demonstrated the same inverse relationship as did the other diseases with ICA or when multiple autoantibodies first appeared together.
CONCLUSIONS/INTERPRETATION


The findings add evidence to the relationships between these atopic diseases and diabetes-related autoimmunity and also suggest that, for eczema, the interaction depends upon which autoantibody appeared first.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00179777 Graphical abstract.",2020,"The incidence of rhinitis was not significantly related to the occurrence of IAA or GADA (statistical power was limited), but demonstrated the same inverse relationship as did the other diseases with ICA or when multiple autoantibodies first appeared together.
","['2159 newborns who had a first-degree relative with type 1 diabetes and selected HLA genotypes were followed until the youngest participant reached 10\xa0years of age', '1106 of these children using the International Study of Asthma and Allergies in Childhood (ISAAC) core questionnaire when the children were 9-11\xa0years old']",[],"['occurrence of IAA or GADA', 'cumulative incidence of atopic eczema, allergic rhinitis and persistent asthma', 'incidence of asthma, allergic rhinitis and eczema', 'Autoantibodies to insulin (IAA), GAD (GADA', 'incidence of rhinitis', 'Islet cell antibodies (ICA']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0444502', 'cui_str': 'First degree'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0004358', 'cui_str': 'Autoantibody'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}, {'cui': 'C0063900', 'cui_str': 'Anti-pancreatic islet cell antibody'}]",2159.0,0.0442462,"The incidence of rhinitis was not significantly related to the occurrence of IAA or GADA (statistical power was limited), but demonstrated the same inverse relationship as did the other diseases with ICA or when multiple autoantibodies first appeared together.
","[{'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Krischer', 'Affiliation': 'Health Informatics Institute, Morsani College of Medicine, University of South Florida, 3650 Spectrum Boulevard, Suite 100, Tampa, FL, 33612, USA. jeffrey.krischer@epi.usf.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cuthbertson', 'Affiliation': 'Health Informatics Institute, Morsani College of Medicine, University of South Florida, 3650 Spectrum Boulevard, Suite 100, Tampa, FL, 33612, USA.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Couluris', 'Affiliation': 'Department of Pediatrics, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Knip', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Suvi M', 'Initials': 'SM', 'LastName': 'Virtanen', 'Affiliation': 'Unit of Public Health Promotion, National Institute for Health and Welfare, Helsinki, Finland.'}]",Diabetologia,['10.1007/s00125-020-05188-3']
881,32554385,Supplemental Text Message Support With the National Diabetes Prevention Program: Pragmatic Comparative Effectiveness Trial.,"BACKGROUND


The evidence-based National Diabetes Prevention Program (NDPP) is now widely disseminated, yet strategies to increase its effectiveness are needed, especially for underserved populations. The yearlong program promotes lifestyle changes for weight loss and can be offered in-person, online, via distance learning, or a combination of modalities. Less is known about which delivery features are optimal and may help address disparities in outcomes for subgroups. We previously demonstrated the efficacy of a stand-alone text messaging intervention based on the NDPP (SMS4PreDM) in a randomized controlled trial in a safety net health care system. Upon broader dissemination, we then showed that SMS4PreDM demonstrated high retention and modest weight loss at a relatively low cost, suggesting the potential to improve in-person NDPP delivery.
OBJECTIVE


In this study, we aim to compare the effectiveness of in-person NDPP classes with and without supplementary SMS4PreDM on attendance and weight loss outcomes to determine whether text messaging can enhance in-person NDPP delivery for a safety net patient population.
METHODS


From 2015 to 2017, patients with diabetes risks were identified primarily from provider referrals and enrolled in NDPP classes, SMS4PreDM, or both per their preference and availability. Participants naturally formed three groups: in-person NDPP with SMS4PreDM (n=236), in-person NDPP alone (n=252), and SMS4PreDM alone (n=285). This analysis compares the first two groups to evaluate whether supplemental text messaging may improve in-person NDPP outcomes. Outcomes for SMS4PreDM-only participants were previously reported. NDPP classes followed standard delivery guidelines, including weekly-to-monthly classes over a year. SMS4PreDM delivery included messages promoting lifestyle change and modest weight loss, sent 6 days per week for 12 months. Differences in characteristics between intervention groups were assessed using chi-square and t tests. Differences in NDPP attendance and weight loss outcomes were analyzed with multivariable linear and logistic regressions.
RESULTS


The mean age was 50.4 years (SD 13.9). Out of a total of 488 participants, 76.2% (n=372) were female and 59.0% (n=288) were Hispanic. An additional 17.2% (n=84) were non-Hispanic white and 12.9% (n=63) were non-Hispanic black. A total of 48.4% (n=236) of participants elected to receive supplemental text message support in addition to NDPP classes. Participants who chose supplemental text message support were on average 5.7 (SD 1.2) years younger (P<.001) than the 252 participants who preferred in-person classes alone. Relatively more women and Hispanic individuals enrolled in the NDPP with supplemental text messages than in NDPP classes alone, 83.9% (n=198) vs 69.0% (n=174, P<.001) and 68.6% (n=162) vs 50.0% (n=126, P=.001), respectively. Attendance and weight loss outcomes were comparable between groups.
CONCLUSIONS


Despite its appeal among priority populations, supplemental text messaging did not significantly increase attendance and weight loss for the in-person NDPP. Further research is needed to identify optimal strategies to improve the effectiveness of the NDPP.",2020,"Despite its appeal among priority populations, supplemental text messaging did not significantly increase attendance and weight loss for the in-person NDPP.","['An additional 17.2% (n=84) were non-Hispanic white and 12.9% (n=63) were non-Hispanic black', 'patients with diabetes risks were identified primarily from provider referrals and enrolled in NDPP classes, SMS4PreDM, or both per their preference and availability', 'From 2015 to 2017', 'Participants naturally formed three groups: in-person NDPP with SMS4PreDM (n=236), in-person NDPP alone (n=252), and SMS4PreDM alone (n=285', 'Out of a total of 488 participants, 76.2% (n=372) were female and 59.0% (n=288) were Hispanic', 'The mean age was 50.4 years (SD 13.9', 'Participants who chose supplemental text message support were on average 5.7 (SD 1.2) years younger (P<.001) than the 252 participants who preferred in-person classes alone']","['SMS4PreDM', 'NDPP (SMS4PreDM', 'supplemental text messaging', 'Supplemental Text Message Support With the National Diabetes Prevention Program', 'stand-alone text messaging intervention', 'person NDPP classes with and without supplementary SMS4PreDM']","['weight loss', 'NDPP attendance and weight loss outcomes', 'Attendance and weight loss outcomes', 'attendance and weight loss']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",488.0,0.157848,"Despite its appeal among priority populations, supplemental text messaging did not significantly increase attendance and weight loss for the in-person NDPP.","[{'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Ritchie', 'Affiliation': 'Denver Health, Denver, CO, United States.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Gutiérrez-Raghunath', 'Affiliation': 'Denver Health, Denver, CO, United States.'}, {'ForeName': 'Michael Josh', 'Initials': 'MJ', 'LastName': 'Durfee', 'Affiliation': 'Denver Health, Denver, CO, United States.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Fischer', 'Affiliation': 'Denver Health, Denver, CO, United States.'}]",JMIR mHealth and uHealth,['10.2196/15478']
882,32572100,Traditional versus blended CPR training program: A randomized controlled non-inferiority study.,"Cardiopulmonary resuscitation (CPR) training and its quality are critical in improving the survival rate of cardiac arrest. This randomized controlled study investigated the efficacy of a newly developed CPR training program for the public in a Taiwanese setting. A total of 832 adults were randomized to either a traditional or blended (18-minute e-learning plus 30-minute hands-on) compression-only CPR training program. The primary outcome was compression depth. Secondary outcomes included CPR knowledge test, practical test, quality of CPR performance, and skill retention. The mean compression depth was 5.21 cm and 5.24 cm in the blended and traditional groups, respectively. The mean difference in compression depth between groups was -0.04 (95% confidence interval -0.13 to infinity), demonstrating that the blended CPR training program was non-inferior to the traditional CPR training program in compression depth after initial training. Secondary outcome results were comparable between groups. Although the mean compression depth and rate were guideline-compliant, only half of the compressions were delivered with adequate depth and rate in both groups. CPR knowledge and skill retained similarly in both groups at 6 and 12 months after training. The blended CPR training program was non-inferior to the traditional CPR training program. However, there is still room for improvement in optimizing initial skill performance as well as skill retention. Clinical Trial Registration: NCT03586752; www.clinicaltrial.gov.",2020,The mean difference in compression depth between groups was -0.04,['832 adults'],"['traditional or blended (18-minute e-learning plus 30-minute hands-on) compression-only CPR training program', 'Traditional versus blended CPR training program', 'blended CPR training program', 'CPR training program', 'Cardiopulmonary resuscitation (CPR) training']","['compression depth', 'mean compression depth', 'CPR knowledge and skill', 'CPR knowledge test, practical test, quality of CPR performance, and skill retention', 'mean compression depth and rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",832.0,0.0353797,The mean difference in compression depth between groups was -0.04,"[{'ForeName': 'Cheng-Yu', 'Initials': 'CY', 'LastName': 'Chien', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Shao-Yu', 'Initials': 'SY', 'LastName': 'Fang', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital Taipei Branch, Taipei, 105, Taiwan.'}, {'ForeName': 'Li-Heng', 'Initials': 'LH', 'LastName': 'Tsai', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Shang-Li', 'Initials': 'SL', 'LastName': 'Tsai', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Chen-Bin', 'Initials': 'CB', 'LastName': 'Chen', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Chen-June', 'Initials': 'CJ', 'LastName': 'Seak', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Weng', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Chi-Chun', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Wei-Che', 'Initials': 'WC', 'LastName': 'Chien', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Chien-Hsiung', 'Initials': 'CH', 'LastName': 'Huang', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Cheng-Yu', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Department of Emergency Medicine, Ton-Yen General Hospital, Zhubei, 302, Taiwan.'}, {'ForeName': 'Chung-Hsien', 'Initials': 'CH', 'LastName': 'Chaou', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Peng-Huei', 'Initials': 'PH', 'LastName': 'Liu', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Hsiao-Jung', 'Initials': 'HJ', 'LastName': 'Tseng', 'Affiliation': 'Biostatistics Unit, Clinical Trial Center, Chang Gung Memorial Hospital, Linkou, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Jih-Chang', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Shu-Yuan', 'Initials': 'SY', 'LastName': 'Peng', 'Affiliation': 'Department of nursing, Ton-Yen General Hospital, Zhubei, 302, Taiwan.'}, {'ForeName': 'Tsung-Hsuan', 'Initials': 'TH', 'LastName': 'Cheng', 'Affiliation': 'Department of nursing, Ton-Yen General Hospital, Zhubei, 302, Taiwan.'}, {'ForeName': 'Kuang-Hung', 'Initials': 'KH', 'LastName': 'Hsu', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Chip-Jin', 'Initials': 'CJ', 'LastName': 'Ng', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan. ngowl@ms3.hinet.net.'}]",Scientific reports,['10.1038/s41598-020-67193-1']
883,32568876,Effect of temperature maintenance by forced-air warming blankets of different temperatures on changes in inflammatory factors in children undergoing congenital hip dislocation surgery.,"BACKGROUND


Hypothermia is associated with many adverse clinical outcomes in pediatric patients, and thus, it is important to find an effective and safe method for preventing peri-operative hypothermia and its associated adverse outcomes in pediatric patients. This study aimed to investigate the effect of forced-air warming blankets with different temperatures on changes in the transforming growth factor-β (TGF-β), tumor necrosis factor (TNF)-α, interleukin (IL)-1β, and IL-10 levels in children undergoing surgical treatment for developmental displacement of the hip (DDH).
METHODS


The study included 123 children undergoing surgery for DDH under general anesthesia. The patients were randomly assigned to three groups, using a random number table: the 32, 38, and 43°C groups according to the temperature setting of the forced-air warming blankets. For each patient, body temperature was recorded immediately after anesthesia induction and intubation (T0), at initial incision (T1), at 1 h after incision (T2), at 2 h after incision (T3), at the end of surgery (T4), immediately upon return to the ward after surgery (T5), and then at 12 h (T6), 24 h (T7), 36 h (T8), and 48 h (T9) after the surgery. The serum levels of TGF-β, TNF-α, IL-1β, and IL-10 were measured at T0 and T4 for all groups.
RESULTS


The number of patients with fever in the 38°C group was significantly less than those in the 32 and 43°C groups (χ = 6.630, P = 0.036). At T0, the body temperatures in the 38 and 43°C groups were significantly higher than that in the 32°C group (F = 17.992, P < 0.001). At T2, the body temperature was significantly higher in the 43°C group than those in the 32 and 38°C groups (F = 12.776, P < 0.001). Moreover, at T4, the serum levels of TGF-β (F = 3286.548, P < 0.001) and IL-10 (F = 4628.983, P < 0.001) were significantly increased in the 38°C group, and the serum levels of TNF-α (F = 911.415, P < 0.001) and IL-1β (F = 322.191, P < 0.001) were significantly decreased in the 38°C group, compared with the levels in the 32 and 43°C groups.
CONCLUSION


Force-air warming blankets set at 38°C maintained stable body temperature with less adverse outcome and effectively inhibited the inflammatory response in pediatric patients undergoing surgery for DDH.
CLINICAL TRIAL REGISTRATION


ChiCTR1800014820; http://www.chictr.org.cn/showproj.aspx?proj=25240.",2020,"The serum levels of TGF-β, TNF-α, IL-1β, and IL-10 were measured at T0 and T4 for all groups.
","['pediatric patients', 'pediatric patients undergoing surgery for DDH', 'children undergoing congenital hip dislocation surgery', 'children undergoing surgical treatment for developmental displacement of the hip (DDH', '123 children undergoing surgery for DDH under general anesthesia']","['temperature maintenance by forced-air warming blankets', 'forced-air warming blankets']","['IL-1β', 'serum levels of TGF-β, TNF-α, IL-1β, and IL-10', 'serum levels of TGF-β', 'body temperature', 'transforming growth factor-β (TGF-β), tumor necrosis factor (TNF)-α, interleukin (IL)-1β, and IL-10 levels', 'serum levels of TNF-α', 'number of patients with fever', 'IL-10', 'body temperatures', 'inflammatory response']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019555', 'cui_str': 'Congenital dislocation of hip'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0184351', 'cui_str': 'Warming blanket'}]","[{'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",123.0,0.057569,"The serum levels of TGF-β, TNF-α, IL-1β, and IL-10 were measured at T0 and T4 for all groups.
","[{'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'He', 'Affiliation': ""Department of Operation Room, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, Guangdong 510623, China.""}, {'ForeName': 'Pei-Zhen', 'Initials': 'PZ', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Yuan-Ming', 'Initials': 'YM', 'LastName': 'Wen', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ''}]",Chinese medical journal,['10.1097/CM9.0000000000000846']
884,32569678,Ovulation inhibition with a new vaginal ring containing trimegestone.,"OBJECTIVES


The primary objective was to determine the lowest trimegestone (TMG) dose, administered via a vaginal ring, that effectively inhibited ovulation.
STUDY DESIGN


Single-centre, open-label, single-dose, parallel-group clinical trial with adaptive design. Eighty healthy female volunteers with proven ovulatory cycles were allocated to treatment with a vaginal ring during 28 days, with an average daily release rate of either 46 µg, 94 µg, 147 µg, or 184 µg TMG (20 women/group). Ultrasound measurements of follicular growth and endometrial thickness, and blood sampling for follicle-stimulating hormone, luteinizing hormone, estradiol and progesterone determinations were performed every 3rd (±1) day from treatment day 4 (±1) until day 28 (±1), and in a follow-up phase after ring removal, until study day 39 (±1). Trimegestone concentrations were measured at each visit in the treatment phase.
RESULTS


Mean age and body mass index were 28.8 years and 23.15 kg/m 2 . One subject in the lowest dose group (46 µg/day) ovulated, no ovulations were seen in the higher dose groups. The degree of ovarian suppression increased with the dose. Median estradiol levels were 119, 36.5, 33.2 and 27.2 pg/mL in the 46, 94, 147 and 184 µg/day groups, respectively. Ovarian activity was resumed in the follow-up phase. Plasma TMG levels gradually declined over the treatment period and showed dose proportionality. The study treatment was safe and well tolerated.
CONCLUSION


The release rate of 94 µg TMG per day was the lowest effective dose for ovulation inhibition. The study results justify further development of the TMG-ring as progestogen-only contraceptive.
IMPLICATIONS


The vaginal ring releasing TMG seems to be an effective new progestogen-only contraceptive preparation, having the advantage of once-a-month vaginal insertion.",2020,"One subject in the lowest dose group (46 µg/day) ovulated, no ovulations were seen in the higher dose groups.","['Mean age and body mass index were 28.8 years and 23.15 kg/m 2 ', 'Eighty healthy female volunteers with proven ovulatory cycles']","['TMG-ring as progestogen-only contraceptive', 'lowest trimegestone (TMG', 'trimegestone']","['Plasma TMG levels', 'Ovulation inhibition', 'degree of ovarian suppression', 'Median estradiol levels', 'Trimegestone concentrations', 'release rate', 'safe and well tolerated', 'Ovarian activity', 'Ultrasound measurements of follicular growth and endometrial thickness, and blood sampling for follicle-stimulating hormone, luteinizing hormone, estradiol and progesterone determinations']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}]","[{'cui': 'C0628822', 'cui_str': 'trimegestone'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0628822', 'cui_str': 'trimegestone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029968', 'cui_str': 'Ovulation Suppression'}, {'cui': 'C0677922', 'cui_str': 'Ovarian ablation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}]",80.0,0.0599633,"One subject in the lowest dose group (46 µg/day) ovulated, no ovulations were seen in the higher dose groups.","[{'ForeName': 'Ingrid J M', 'Initials': 'IJM', 'LastName': 'Duijkers', 'Affiliation': 'Dinox Consultancy BV, Marktstraat 19, 9712 PB Groningen, the Netherlands. Electronic address: id@dinoxconsultancy.com.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Klipping', 'Affiliation': 'Dinox Consultancy BV, Marktstraat 19, 9712 PB Groningen, the Netherlands; Dinox GmbH, Anklamer Strasse 38, 10115 Berlin, Germany. Electronic address: ck@dinoxconsultancy.com.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Draeger', 'Affiliation': 'Dinox GmbH, Anklamer Strasse 38, 10115 Berlin, Germany. Electronic address: corinna.draeger@dinox.de.'}, {'ForeName': 'Barbara S', 'Initials': 'BS', 'LastName': 'Schug', 'Affiliation': 'SocraTec R&D GmbH, Im Setzling 35, 61440 Oberursel, Germany. Electronic address: Barbara.Schug@socratec-pharma.de.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Dax', 'Affiliation': 'SocraTec R&D GmbH, Im Setzling 35, 61440 Oberursel, Germany. Electronic address: Annika.Dax@socratec-pharma.de.'}, {'ForeName': 'Maika', 'Initials': 'M', 'LastName': 'Friedrich', 'Affiliation': 'Evestra GmbH, Britzer Straße 26, 12439 Berlin, Germany. Electronic address: mfriedrich@evestra.com.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Nickisch', 'Affiliation': 'Evestra GmbH, Britzer Straße 26, 12439 Berlin, Germany. Electronic address: knickisch@evestra.com.'}]",Contraception,['10.1016/j.contraception.2020.06.006']
885,32442384,Cycling reduces blood glucose excursions after an oral glucose tolerance test in pregnant women: a randomized crossover trial.,"The aim of this study was to evaluate the effect of an acute bout of cycling immediately after oral glucose intake on glucose metabolism in pregnant women at risk for gestational diabetes mellitus (GDM). Fifteen pregnant women with BMI ≥ 27 kg/m 2  were enrolled in a randomized crossover controlled study and underwent two oral glucose tolerance tests (OGTTs) ingesting 75 g of glucose followed by either 20 min of stationary cycling at moderate intensity (65%-75% maximal heart rate) or rest. Using continuous glucose monitors, glucose was measured up to 48 h after the OGTT. Glucose, insulin, and C-peptide were determined at baseline and after 1 and 2 h. One hour after glucose intake, mean blood glucose was significantly lower after cycling compared with rest ( p  = 0.002). Similarly, mean glucose peak level was significantly lower after cycling compared with after rest ( p =  0.039). Lower levels of insulin and C-peptide were observed after 1 h ( p  < 0.01). Differences in glucose measurements after 2 h and up to 48 h were not statistically different. We found that 20 min of cycling at moderate intensity after glucose intake reduced blood glucose excursions in pregnant women at risk for GDM. ClinicalTrials.gov Identifier: NCT03644238.  Novelty Bullets  In pregnant women, we found that cycling after glucose intake resulted in significantly lower glucose levels compared with rest. The exercise intervention studied is feasible for pregnant women and could be readily used to reduce glucose excursions.",2020,"One hour after glucose intake, mean blood glucose was significantly lower after cycling compared to rest (p=0.002).","['pregnant women at risk for GDM. Novelty Bullets: •', 'pregnant women at risk for gestational diabetes mellitus (GDM', 'Fifteen pregnant women with BMI ≥ 27kg/m2', 'pregnant women']","['oral glucose tolerance tests (OGTTs) ingesting 75-gram glucose followed by either 20 minutes of stationary cycling', 'exercise intervention', 'oral glucose intake']","['Glucose, insulin and C-peptide', 'blood glucose excursions', 'glucose measurements', 'glucose levels', 'mean blood glucose', 'glucose metabolism', 'mean glucose peak level', 'Lower levels of insulin and C-peptide']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0336699', 'cui_str': 'Bullet'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439835', 'cui_str': 'Stationary'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556133', 'cui_str': 'Glucose intake'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",15.0,0.0364558,"One hour after glucose intake, mean blood glucose was significantly lower after cycling compared to rest (p=0.002).","[{'ForeName': 'Mette Bisgaard', 'Initials': 'MB', 'LastName': 'Andersen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N., Denmark.'}, {'ForeName': 'Per Glud', 'Initials': 'PG', 'LastName': 'Ovesen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N., Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Daugaard', 'Affiliation': 'Department of Obstetrics and Gynecology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N., Denmark.'}, {'ForeName': 'Eva Bjerre', 'Initials': 'EB', 'LastName': 'Ostenfeld', 'Affiliation': 'Department of Obstetrics and Gynecology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N., Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Fuglsang', 'Affiliation': 'Department of Obstetrics and Gynecology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N., Denmark.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0020']
886,32446323,Estimating lifetime benefits of comprehensive disease-modifying pharmacological therapies in patients with heart failure with reduced ejection fraction: a comparative analysis of three randomised controlled trials.,"BACKGROUND


Three drug classes (mineralocorticoid receptor antagonists [MRAs], angiotensin receptor-neprilysin inhibitors [ARNIs], and sodium/glucose cotransporter 2 [SGLT2] inhibitors) reduce mortality in patients with heart failure with reduced ejection fraction (HFrEF) beyond conventional therapy consisting of angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) and β blockers. Each class was previously studied with different background therapies and the expected treatment benefits with their combined use are not known. Here, we used data from three previously reported randomised controlled trials to estimate lifetime gains in event-free survival and overall survival with comprehensive therapy versus conventional therapy in patients with chronic HFrEF.
METHODS


In this cross-trial analysis, we estimated treatment effects of comprehensive disease-modifying pharmacological therapy (ARNI, β blocker, MRA, and SGLT2 inhibitor) versus conventional therapy (ACE inhibitor or ARB and β blocker) in patients with chronic HFrEF by making indirect comparisons of three pivotal trials, EMPHASIS-HF (n=2737), PARADIGM-HF (n=8399), and DAPA-HF (n=4744). Our primary endpoint was a composite of cardiovascular death or first hospital admission for heart failure; we also assessed these endpoints individually and assessed all-cause mortality. Assuming these relative treatment effects are consistent over time, we then projected incremental long-term gains in event-free survival and overall survival with comprehensive disease-modifying therapy in the control group of the EMPHASIS-HF trial (ACE inhibitor or ARB and β blocker).
FINDINGS


The hazard ratio (HR) for the imputed aggregate treatment effects of comprehensive disease-modifying therapy versus conventional therapy on the primary endpoint of cardiovascular death or hospital admission for heart failure was 0·38 (95% CI 0·30-0·47). HRs were also favourable for cardiovascular death alone (HR 0·50 [95% CI 0·37-0·67]), hospital admission for heart failure alone (0·32 [0·24-0·43]), and all-cause mortality (0·53 [0·40-0·70]). Treatment with comprehensive disease-modifying pharmacological therapy was estimated to afford 2·7 additional years (for an 80-year-old) to 8·3 additional years (for a 55-year-old) free from cardiovascular death or first hospital admission for heart failure and 1·4 additional years (for an 80-year-old) to 6·3 additional years (for a 55-year-old) of survival compared with conventional therapy.
INTERPRETATION


Among patients with HFrEF, the anticipated aggregate treatment effects of early comprehensive disease-modifying pharmacological therapy are substantial and support the combination use of an ARNI, β blocker, MRA, and SGLT2 inhibitor as a new therapeutic standard.
FUNDING


None.",2020,HRs were also favourable for cardiovascular death alone (HR 0·50 [,"['patients with heart failure with reduced ejection fraction (HFrEF) beyond conventional therapy consisting of', '2·7 additional years (for an 80-year-old) to 8·3 additional years (for a 55-year-old) free from cardiovascular death or first hospital admission for heart failure and 1·4 additional years (for an 80-year-old) to 6·3 additional years (for a 55-year-old) of survival compared with conventional therapy', 'patients with HFrEF', 'patients with heart failure with reduced ejection fraction', 'patients with chronic HFrEF.\nMETHODS', 'patients with chronic HFrEF by making indirect comparisons of three pivotal trials, EMPHASIS-HF (n=2737), PARADIGM-HF (n=8399), and DAPA-HF (n=4744']","['comprehensive disease-modifying pharmacological therapy', 'angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) and β blockers', 'comprehensive disease-modifying pharmacological therapies', 'comprehensive therapy versus conventional therapy', 'comprehensive disease-modifying pharmacological therapy (ARNI, β blocker, MRA, and SGLT2 inhibitor) versus conventional therapy (ACE inhibitor or ARB and β blocker']","['cardiovascular death or hospital admission for heart failure', 'hospital admission for heart failure alone (0·32', 'hazard ratio (HR', 'composite of cardiovascular death or first hospital admission for heart failure', 'cardiovascular death alone (HR 0·50 ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4280934', 'cui_str': 'Reduced ejection fraction co-occurrent and due to chronic heart failure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0243032', 'cui_str': 'Magnetic resonance imaging (MRI) of vessels'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",,0.181843,HRs were also favourable for cardiovascular death alone (HR 0·50 [,"[{'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Cunningham', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Pedro Ferreira', 'Affiliation': ""Université de Lorraine INSERM, Centre d'Investigations Cliniques Plurithématique 1433, INSERM U1116, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, France; Department of Physiology and Cardiothoracic Surgery, University of Porto, Porto, Portugal.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine INSERM, Centre d'Investigations Cliniques Plurithématique 1433, INSERM U1116, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA; Imperial College, London, UK.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Division of Cardiology, David Geffen School of Medicine, University of California, Los Angeles Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: ssolomon@bwh.harvard.edu.""}]","Lancet (London, England)",['10.1016/S0140-6736(20)30748-0']
887,32446470,"Effect of State Immunization Information System Based Reminder/Recall for Influenza Vaccinations: A Randomized Trial of Autodialer, Text, and Mailed Messages.","OBJECTIVE


To evaluate the effect of different modalities of centralized reminder/recall (autodialer, text, mailed reminders) on increasing childhood influenza vaccination.
STUDY DESIGN


Two simultaneous randomized clinical trials conducted from October 2017 to April 1, 2018, in New York State and Colorado. There were 61 931 children in New York (136 practices) and 23 845 children in Colorado (42 practices) who were randomized to different centralized reminder/recall modalities-4 arms in New York (autodialer, text, mailed, and no reminder control) and 3 arms in Colorado (autodialer, mailed, and no reminder control). The message content was similar across modalities. Up to 3 reminders were sent for intervention arms. The main outcome measure was receipt of ≥1 influenza vaccine.
RESULTS


In New York, compared with the control arm (26.6%), postintervention influenza vaccination rates in the autodialer arm (28.0%) were 1.4 percentage points higher (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10), but the rates for text (27.6%) and mail (26.8%) arms were not different from controls. In Colorado, compared with the control arm (29.9%), postintervention influenza vaccination rates for the autodialer (32.9%) and mail (31.5%) arms were 3.0 percentage points (adjusted risk ratio, 1.08; 95% CI, 1.03-1.12) and 1.6 percentage points (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10) higher, respectively. Compared with the control arm, the incremental cost per additional vaccine delivered was $20 (New York) and $16 (Colorado) for autodialer messages.
CONCLUSIONS


Centralized reminder/recall for childhood influenza vaccine was most effective via autodialer, less effective via mail, and not effective via text messages. The impact of each modality was modest. Compared with no reminders, the incremental cost per additional vaccine delivered was also modest for autodialer messages.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03294473 and NCT03246100.",2020,"In Colorado, compared with the control arm (29.9%), postintervention influenza vaccination rates for the autodialer (32.9%) and mail (31.5%) arms were 3.0 percentage points (adjusted risk ratio, 1.08; 95% CI, 1.03-1.12) and 1.6 percentage points (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10) higher, respectively.","['Influenza Vaccinations', '61 931 children in New York (136 practices) and 23 845 children in Colorado (42 practices', 'October 2017 to April 1, 2018, in New York State and Colorado']","['centralized reminder/recall (autodialer, text, mailed reminders', 'centralized reminder/recall modalities-4 arms in New York (autodialer, text, mailed, and no reminder control) and 3 arms in Colorado (autodialer, mailed, and no reminder control']","['postintervention influenza vaccination rates', 'receipt of ≥1 influenza vaccine']","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}]","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]",61931.0,0.279722,"In Colorado, compared with the control arm (29.9%), postintervention influenza vaccination rates for the autodialer (32.9%) and mail (31.5%) arms were 3.0 percentage points (adjusted risk ratio, 1.08; 95% CI, 1.03-1.12) and 1.6 percentage points (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10) higher, respectively.","[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Szilagyi', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA. Electronic address: pszilagyi@mednet.ucla.edu.""}, {'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'Albertin', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Alison W', 'Initials': 'AW', 'LastName': 'Saville', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Valderrama', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Breck', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Helmkamp', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Xinkai', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, CA.'}, {'ForeName': 'Sitaram', 'Initials': 'S', 'LastName': 'Vangala', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, CA.'}, {'ForeName': 'L Miriam', 'Initials': 'LM', 'LastName': 'Dickinson', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, CA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Campbell', 'Affiliation': 'Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Melanie D', 'Initials': 'MD', 'LastName': 'Whittington', 'Affiliation': 'Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Roth', 'Affiliation': 'Colorado Immunization Information System, Colorado Department of Public Health and Environment, Denver, CO.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Rand', 'Affiliation': 'Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, NY.'}, {'ForeName': 'Sharon G', 'Initials': 'SG', 'LastName': 'Humiston', 'Affiliation': ""Department of Pediatrics, Children's Mercy, Kansas City, MO.""}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Hoefer', 'Affiliation': 'New York State Immunization Information System, New York State Department of Health, New York, NY.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kempe', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.02.020']
888,32452588,"A Phase II, Single-Arm, Open-Label, Bayesian Adaptive Efficacy and Safety Study of PBI-05204 in Patients with Stage IV Metastatic Pancreatic Adenocarcinoma.","LESSONS LEARNED


This trial evaluating a novel plant extract, PBI-05204, did not meet its primary endpoint of overall survival but did show signals of efficacy in heavily pretreated mPDA. PBI-05204 was generally well tolerated, with the most common side effects related to treatment being vomiting (23.7%), nausea (18.4%), decreased appetite (18.4%), and diarrhea (15.8%). Additional trials are needed to explore the role of PBI-05204 in cancer treatment.
BACKGROUND


Survival for metastatic pancreatic ductal adenocarcinoma (mPDA) is dismal, and novel agents are needed. PBI-05204 is a modified supercritical carbon dioxide extract of Nerium oleander leaves. Oleandrin, the extract's major cytotoxic component, is a cardiac glycoside that has demonstrated antitumor activity in various tumor cell lines with a mechanism involving inhibition of Akt phosphorylation and through downregulation of mTOR.
METHODS


A phase II, single-arm, open-label study to determine the efficacy of PBI-05204 in patients with refractory mPDA therapy was conducted. The primary endpoint was overall survival (OS), with the hypothesis that 50% of patients would be alive at 4.5 months. Secondary objectives included safety, progression-free survival (PFS), and overall response rate. Patients received oral PBI-05204 daily until progressive disease (PD), unacceptable toxicity, or patient withdrawal. Radiographic response was assessed every two cycles.
RESULTS


Forty-two patients were enrolled, and 38 were analyzed. Ten patients were alive at 4.5 months (26.3%) with a median PFS of 56 days. One objective response (2.6%) was observed for 162 days. Grade ≥ 3 treatment-emergent adverse events occurred in 63.2% of patients with the most common being fatigue, vomiting, nausea, decreased appetite, and diarrhea.
CONCLUSION


PBI-05204 did not meet its primary endpoint for OS in this study. Recent preclinical data indicate a role for PBI-05204 against glioblastoma multiforme when combined with chemotherapy and radiotherapy. A randomized phase II trial is currently being designed.",2020,"3 treatment-emergent adverse events occurred in 63.2% of patients with the most common being fatigue, vomiting, nausea, decreased appetite, and diarrhea.
","['patients with refractory mPDA therapy was conducted', 'metastatic pancreatic ductal adenocarcinoma (mPDA', 'Forty-two patients were enrolled, and 38 were analyzed', 'Patients with Stage IV Metastatic Pancreatic Adenocarcinoma']","['PBI-05204', 'chemotherapy and radiotherapy', 'Oleandrin']","['diarrhea', 'fatigue, vomiting, nausea, decreased appetite, and diarrhea', 'overall survival', 'Radiographic response', 'vomiting', 'Grade ≥', 'safety, progression-free survival (PFS), and overall response rate', 'adverse events', 'nausea', 'overall survival (OS', 'decreased appetite']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0861727', 'cui_str': 'Pancreatic adenocarcinoma metastatic'}]","[{'cui': 'C2987707', 'cui_str': 'PBI-05204'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0069397', 'cui_str': 'Oleandrin'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",10.0,0.0807327,"3 treatment-emergent adverse events occurred in 63.2% of patients with the most common being fatigue, vomiting, nausea, decreased appetite, and diarrhea.
","[{'ForeName': 'Marc T', 'Initials': 'MT', 'LastName': 'Roth', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Dana Backlund', 'Initials': 'DB', 'LastName': 'Cardin', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Erkut Hasan', 'Initials': 'EH', 'LastName': 'Borazanci', 'Affiliation': 'HonorHealth Research Institute, Scottsdale, Arizona, USA.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Steinbach', 'Affiliation': 'HonorHealth Research Institute, Scottsdale, Arizona, USA.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Picozzi', 'Affiliation': 'Virginia Mason Hospital and Medical Center, Seattle, Washington, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rosemury', 'Affiliation': 'AdventHealth Tampa, Tampa, Florida, USA.'}, {'ForeName': 'Raymond Couric', 'Initials': 'RC', 'LastName': 'Wadlow', 'Affiliation': 'Virginia Cancer Specialists, Fairfax, Virginia, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Newman', 'Affiliation': 'MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Berlin', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, USA.'}]",The oncologist,['10.1634/theoncologist.2020-0440']
889,32452659,"Pharmacokinetics and Bioequivalence of Clopidogrel Hydrogen Sulfate Tablets in Fed and Fasted Conditions: An Open-Label, Randomized, Semireplicated Crossover Study in Healthy Chinese Volunteers.","Clopidogrel is an antiplatelet drug with high intraindividual variability in systemic exposure and efficacy. It has been used for treating atherosclerosis and acute coronary syndrome and in preventing stent restenosis and thrombotic complications after stent implantation in clinical practice for nearly 20 years. In this study we aimed to evaluate the bioequivalence of 2 clopidogrel hydrogen sulfate formulations (75-mg tablets) under fed (n = 66) and fasted (n = 66) conditions by using the reference-scaled average bioequivalence method. An open-label, randomized, 3-sequence and 3-period crossover (3×3), semireplicated study was designed and conducted. Clopidogrel concentration of plasma samples was measured by high-precision liquid chromatography and tandem mass spectrometry. The pharmacokinetic parameters were derived by a noncompartmental model. In the fed condition the geometric least-squares mean ratios of peak concentration (C max  ) and area under the concentration-time curve (AUC 0-t  ) were, respectively, 103.38% and 98.97%, and the corresponding 90%CIs were 95.68% to 111.70% and 94.67% to 103.47%. In the fasted condition the geometric least squares mean ratios of C max  and AUC 0-t  were, respectively, 106.53% and 105.77%, and the corresponding 90%CIs were 97.62% to 116.25% and 96.96% to 115.38%. According to the criteria for bioequivalence (80.00% to 125.00%), the test formulations of clopidogrel and Plavix were determined to be bioequivalent.",2020,"According to the criteria for bioequivalence (80.00% to 125.00%), the test formulations of clopidogrel and Plavix were determined to be bioequivalent.","['Fed and Fasted Conditions', 'Healthy Chinese Volunteers']","['clopidogrel hydrogen sulfate formulations', 'Clopidogrel Hydrogen Sulfate Tablet', 'Clopidogrel']","['geometric least squares mean ratios of C max  and AUC 0-t', 'Clopidogrel concentration of plasma samples', 'geometric least-squares mean ratios of peak concentration (C max  ) and area under the concentration-time curve (AUC 0-t  ']","[{'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0772326', 'cui_str': 'Clopidogrel bisulfate'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",66.0,0.0275802,"According to the criteria for bioequivalence (80.00% to 125.00%), the test formulations of clopidogrel and Plavix were determined to be bioequivalent.","[{'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Pei', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Chaoying', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Shili', 'Initials': 'S', 'LastName': 'Gong', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.804']
890,32449919,Orthostatic Blood Pressure Recovery Is Associated With the Rate of Cognitive Decline and Mortality in Clinical Alzheimer's Disease.,"BACKGROUND


Impaired recovery of blood pressure (BP) after standing has been shown to be related to cognitive function and mortality in people without dementia, but its role in people with Alzheimer's disease (AD) is unknown. The aim of this study was to investigate the association of the orthostatic BP response with cognitive decline and mortality in AD.
METHODS


In this post hoc analysis of a randomized controlled trial (Nilvad), we measured the beat-to-beat response of BP upon active standing in mild-to-moderate AD. This included the initial drop (nadir within 40 seconds) and recovery after 1 minute, both expressed relative to resting values. We examined the relationship between a small or large initial drop (median split) and unimpaired (≥100%) or impaired recovery (<100%) with 1.5-year change in Alzheimer's Disease Assessment-cognitive subscale (ADAS-cog) scores and all-cause mortality.
RESULTS


We included 55 participants (age 73.1 ± 6.2 years). Impaired BP recovery was associated with higher increases in ADAS-cog scores (systolic: β [95% confidence interval] = 5.6 [0.4-10.8], p = .035; diastolic: 7.6 [2.3-13.0], p = .006). During a median follow-up time of 49 months, 20 participants died. Impaired BP recovery was associated with increased mortality (systolic: HR [95% confidence interval] = 2.9 [1.1-7.8], p = .039; diastolic: HR [95% confidence interval] = 5.5 [1.9-16.1], p = .002). The initial BP drop was not associated with any outcome. Results were adjusted for age, sex, and intervention group.
CONCLUSIONS


Failure to fully recover BP after 1 minute of standing is associated with cognitive decline and mortality in AD. As such, BP recovery can be regarded as an easily obtained marker of progression rate of AD.",2020,"Impaired BP recovery was associated with increased mortality (systolic: HR [95% CI]=2.9 [1.1-7.8], p=0.039; diastolic: HR [95%","[""people with Alzheimer's disease (AD"", '55 participants (age 73.1±6.2 years']",[],"['mortality (systolic: HR', 'orthostatic BP response', 'Impaired BP recovery', 'ADAS-cog scores (systolic: β', 'blood pressure (BP', 'Orthostatic blood pressure recovery', ""Alzheimer's Disease Assessment-cognitive subscale (ADAS-cog) scores and all-cause mortality""]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",55.0,0.363489,"Impaired BP recovery was associated with increased mortality (systolic: HR [95% CI]=2.9 [1.1-7.8], p=0.039; diastolic: HR [95%","[{'ForeName': 'Rianne A A', 'Initials': 'RAA', 'LastName': 'de Heus', 'Affiliation': 'Department of Geriatric Medicine, Radboudumc Alzheimer Center, Radboud University Medical Center, Donders Institute for Brain Cognition and Behaviour, Nijmegen, The Netherlands.'}, {'ForeName': 'Daan L K', 'Initials': 'DLK', 'LastName': 'de Jong', 'Affiliation': 'Department of Geriatric Medicine, Radboudumc Alzheimer Center, Radboud University Medical Center, Donders Institute for Brain Cognition and Behaviour, Nijmegen, The Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rijpma', 'Affiliation': 'Department of Geriatric Medicine, Radboudumc Alzheimer Center, Radboud University Medical Center, Donders Institute for Brain Cognition and Behaviour, Nijmegen, The Netherlands.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Lawlor', 'Affiliation': ""Mercer's Institute for Research on Ageing, St. James's Hospital, Dublin, Ireland.""}, {'ForeName': 'Marcel G M', 'Initials': 'MGM', 'LastName': 'Olde Rikkert', 'Affiliation': 'Department of Geriatric Medicine, Radboudumc Alzheimer Center, Radboud University Medical Center, Donders Institute for Brain Cognition and Behaviour, Nijmegen, The Netherlands.'}, {'ForeName': 'Jurgen A H R', 'Initials': 'JAHR', 'LastName': 'Claassen', 'Affiliation': 'Department of Geriatric Medicine, Radboudumc Alzheimer Center, Radboud University Medical Center, Donders Institute for Brain Cognition and Behaviour, Nijmegen, The Netherlands.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa129']
891,32454841,The Restorative Effect of the Natural Environment on University Students' Psychological Health.,"The present study evaluated the effect of a three-week intervention aimed at improving psychological health in university students. Participants included 200 Australian students randomly assigned to an experimental or waitlist control group, with 42 adhering to intervention instructions. Participants in the experimental group read a story about someone who used the natural environment to decrease stress and burnout levels and to increase their perceived satisfaction with life. They were then instructed to spend 20 minutes each week, for three weeks, in any chosen natural environment. Waitlist control participants received intervention instructions three weeks later. Restorativeness was positively associated with life satisfaction and negatively related to stress and burnout. Experimental participants, compared to waitlist control participants, experienced a significant decrease in stress; however, the intervention had no effect on life satisfaction or burnout. More research is still needed to determine the practical significance of nature exposure on university students' psychological health.",2020,"Experimental participants, compared to waitlist control participants, experienced a significant decrease in stress; however, the intervention had no effect on life satisfaction or burnout.","['university students', 'Participants included 200 Australian students randomly assigned to an', ""University Students' Psychological Health""]","['experimental or waitlist control group, with 42 adhering to intervention instructions', 'Natural Environment']","['psychological health', 'stress', 'life satisfaction']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0557745', 'cui_str': 'Natural environment'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",200.0,0.0230612,"Experimental participants, compared to waitlist control participants, experienced a significant decrease in stress; however, the intervention had no effect on life satisfaction or burnout.","[{'ForeName': 'Emma A', 'Initials': 'EA', 'LastName': 'Payne', 'Affiliation': 'University of New England, Armidale, Australia.'}, {'ForeName': 'Natasha M', 'Initials': 'NM', 'LastName': 'Loi', 'Affiliation': 'University of New England, Armidale, Australia.'}, {'ForeName': 'Einar B', 'Initials': 'EB', 'LastName': 'Thorsteinsson', 'Affiliation': 'University of New England, Armidale, Australia.'}]",Journal of environmental and public health,['10.1155/2020/4210285']
892,32458640,Sequential Chemoradiotherapy Compared to Radiotherapy in Endometrial Carcinoma.,"BACKGROUND


The role of combined modality in the adjuvant treatment of Endometrial Cancer has not been established. This study aims to assess the benefits of Sequential Chemoradiotherapy (SCRT) compared to Radiotherapy (RT) alone in the treatment of patients with Endometrial Cancer.
METHODS


Retrospective analysis of patients with Endometrial Cancer stage I to stage III C at King Abdullah Medical city, Makkah. Each group of patients was assigned to receive External pelvic RT, brachytherapy or both. While a second group received SCRT consisting of six cycles of Carboplatin (AUC 5) and Paclitaxel 175 mg/m2 followed by radiotherapy.
RESULTS


Fifty-six women were treated of which 26 received SCRT and 30 received RT. The two groups had a median age of 58 years old ranging from 34 - 84 years old with no other statistically significant difference. Patients who received SCRT had poorer prognostic tumor characteris-tics. Median follow-up was 29.6 months (95% CI: 19.6-39.5 months). All deaths (n=5) were exclusively in the RT group. The 2 and 4-year OS rates were 100% and 100% in SCRT group versus 87.3% and 64.9% in RT group (hazard ratio [HR] 0.018 [95% CI: 0-24.4; p= 0.038); The 2- and 4-year DFS were 100% and 100% in SCRT group versus 78.1% and 43.9% in RT group (HR 0.102 [95% CI: 0.103-0.805; p= 0.008).
CONCLUSION


Adjuvant chemotherapy given before radiotherapy for Endometrial Cancer may lessen the effect of high-risk features on the DFS and OS. Randomized clinical trials are needed to determine the benefits of early Systemic Therapy.",2020,Adjuvant chemotherapy given before radiotherapy for Endometrial Cancer may lessen the effect of high-risk features on the DFS and OS.,"['patients with Endometrial Cancer', 'Endometrial Carcinoma', 'patients with Endometrial Cancer stage I to stage III C at King Abdullah Medical city, Makkah', 'Fifty-six women']","['RT', 'External pelvic RT, brachytherapy or both', 'Adjuvant chemotherapy', 'Sequential Chemoradiotherapy', 'Radiotherapy (RT) alone', 'SCRT', 'Sequential Chemoradiotherapy (SCRT', 'Carboplatin (AUC 5) and Paclitaxel 175 mg/m2 followed by radiotherapy', 'Radiotherapy']","['2- and 4-year DFS', 'prognostic tumor characteris-tics', '4-year OS rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0476089', 'cui_str': 'Endometrial carcinoma'}, {'cui': 'C0278798', 'cui_str': 'Endometrial cancer stage I'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}]",56.0,0.160064,Adjuvant chemotherapy given before radiotherapy for Endometrial Cancer may lessen the effect of high-risk features on the DFS and OS.,"[{'ForeName': 'Omima', 'Initials': 'O', 'LastName': 'Elemam', 'Affiliation': 'Oncology Center, King Abdullah Medical City, Makkah, Saudi Arabia.'}, {'ForeName': 'Seham', 'Initials': 'S', 'LastName': 'Abdelkhalek', 'Affiliation': 'Oncology Center, King Abdullah Medical City, Makkah, Saudi Arabia.'}, {'ForeName': 'Doaa', 'Initials': 'D', 'LastName': 'Abdelmoety', 'Affiliation': 'Research Center, King Abdullah Medical City, Makkah, Saudi Arabia.'}, {'ForeName': 'Engy', 'Initials': 'E', 'LastName': 'Aboelnaga', 'Affiliation': 'Department of Radiotherapy , Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Baraka', 'Affiliation': 'Department of Biology, Colorado State University, Fort Collins, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Zeeneldine', 'Affiliation': 'Oncology Center, King Abdullah Medical City, Makkah, Saudi Arabia.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.5.1327']
893,32458647,"A Prospective Randomized Trial to Compare Safety, Acceptability and Efficacy of Thermal Ablation and Cryotherapy in a Screen and Treat Setting.","BACKGROUND


The prospective randomized study aimed to compare the safety, acceptability and efficacy of thermal ablation (TA) to that of cryotherapy in screen and treat setting.
METHODS


The participants were recruited prospectively in a community-based screening clinic in India. Women positive on visual inspection with acetic acid (VIA) test and/or Human Papillomavirus (HPV) test were assessed for eligibility for ablative treatment. Total 286 eligible women were randomized to receive either cryotherapy (N=150) or TA (N=136) performed by health workers. Colposcopy and cervical biopsy were performed on all, prior to treatment. Post-treatment follow-up was after one year with colposcopy and biopsy.
RESULTS


Both the treatment methods had high acceptability. Significantly higher proportion of women treated by cryotherapy reported pain compared to women treated by TA, though intensity was mild in vast majority of them. Approximately 30% of women in both arms had histologic abnormalities, mainly CIN 1, and among those who attended follow-up 74.1% and 81.0% didn't have any CIN after cryotherapy and TA respectively.
CONCLUSION


TA is as acceptable and safe as cryotherapy in screen and treat setting. TA has the logistic advantages for the low-resourced settings as the machines are more portable, do not require costly refrigerant gas and battery-driven models are available. The cure rates for CIN 1+ lesions in our study were comparable between cryotherapy and TA.",2020,"Significantly higher proportion of women treated by cryotherapy reported pain compared to women treated by TA, though intensity was mild in vast majority of them.","['N=136) performed by health workers', 'participants were recruited prospectively in a community-based screening clinic in India', 'Total 286 eligible women']","['thermal ablation (TA', 'Thermal Ablation and Cryotherapy', 'acetic acid (VIA) test and/or Human Papillomavirus (HPV', 'TA', 'cryotherapy (N=150) or TA']","['safety, acceptability and efficacy', 'histologic abnormalities', 'cure rates', 'pain']","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0677798', 'cui_str': 'Thermal ablation'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",286.0,0.0659985,"Significantly higher proportion of women treated by cryotherapy reported pain compared to women treated by TA, though intensity was mild in vast majority of them.","[{'ForeName': 'Dipanwita', 'Initials': 'D', 'LastName': 'Banerjee', 'Affiliation': 'Chittaranjan National Cancer Institute, Kolkata, West Bengal, India.'}, {'ForeName': 'Ranajit', 'Initials': 'R', 'LastName': 'Mandal', 'Affiliation': 'Chittaranjan National Cancer Institute, Kolkata, West Bengal, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Mandal', 'Affiliation': 'Chittaranjan National Cancer Institute, Kolkata, West Bengal, India.'}, {'ForeName': 'Ishita', 'Initials': 'I', 'LastName': 'Ghosh', 'Affiliation': 'Chittaranjan National Cancer Institute, Kolkata, West Bengal, India.'}, {'ForeName': 'Srabani', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Chittaranjan National Cancer Institute, Kolkata, West Bengal, India.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Muwonge', 'Affiliation': 'International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lucas', 'Affiliation': 'International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Partha', 'Initials': 'P', 'LastName': 'Basu', 'Affiliation': 'International Agency for Research on Cancer, Lyon, France.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.5.1391']
894,32482455,Does exercising before or after a meal affect energy balance in adolescents with obesity?,"BACKGROUND AND AIM


Exercise timing has been suggested to affect appetite and energy intake (EI). The aim of this study was to examine the impact of exercising immediately before or after a meal on EI, appetite sensations and food reward (FR) in adolescents with obesity.
METHODS AND RESULTS


Seventeen adolescents with obesity completed 3 experimental sessions (randomized controlled trial): rest + lunch (CON); exercise + lunch (EX-MEAL); lunch + exercise (MEAL-EX). The exercise consisted of cycling 30 min at 65%V̇O 2peak . Outcomes included ad libitum EI (weighed lunch and dinner), FR (Leeds Food Preference Questionnaire at pre- and post-combination of exercise/rest and lunch, and pre-dinner) and appetite sensations (visual analogue scales). EI was not different between conditions. Compared with CON, relative EI at lunch was lower in EX-MEAL and MEAL-EX (p ≤ 0.05) and daily only in MEAL-EX (p < 0.01). Postprandial fullness was higher in EX-MEAL compared to CON. Compared with CON, both EX-MEAL and MEAL-EX attenuated the increase in wanting for sweet food and reduced explicit liking for fat.
CONCLUSIONS


These preliminary results suggest that exercising immediately before or after a meal produce few differences in appetite and have small beneficial effects on overall energy balance in adolescents with obesity, as well as on FR.
CLINICAL TRIALS


NCT03967782.",2020,"Compared with CON, relative EI at lunch was lower in EX-MEAL and MEAL-EX (p ≤ 0.05) and daily only in MEAL-EX (p < 0.01).","['adolescents with obesity', 'Seventeen adolescents with obesity completed 3 experimental sessions (randomized controlled trial']","['rest\xa0+\xa0lunch (CON); exercise\xa0+\xa0lunch (EX-MEAL); lunch\xa0+\xa0exercise (MEAL-EX', 'CON, both EX-MEAL and MEAL-EX']","['Postprandial fullness', 'EI, appetite sensations and food reward (FR', 'wanting for sweet food and reduced explicit liking', 'overall energy balance', 'ad libitum EI (weighed lunch and dinner), FR (Leeds Food Preference Questionnaire at pre- and post-combination of exercise/rest and lunch, and pre-dinner) and appetite sensations (visual analogue scales', 'appetite and energy intake (EI']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0453865', 'cui_str': 'Sweet food'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",17.0,0.0334859,"Compared with CON, relative EI at lunch was lower in EX-MEAL and MEAL-EX (p ≤ 0.05) and daily only in MEAL-EX (p < 0.01).","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Fillon', 'Affiliation': 'Université Clermont Auvergne, AME2P, F-63000, Clermont-Ferrand, France; UGECAM Obesity Hospital, Clermont-Ferrand, France. Electronic address: fillonalicia@gmail.com.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Beaulieu', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Miguet', 'Affiliation': 'Université Clermont Auvergne, AME2P, F-63000, Clermont-Ferrand, France.'}, {'ForeName': 'Mélina', 'Initials': 'M', 'LastName': 'Bailly', 'Affiliation': 'Université Clermont Auvergne, AME2P, F-63000, Clermont-Ferrand, France.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Julian', 'Affiliation': 'CHU, Clermont-Ferrand, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Masurier', 'Affiliation': 'UGECAM Obesity Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Mathieu', 'Affiliation': 'Department of Kinesiology, University of Montreal, 2100 Edouard-Montpetit, Montreal, H3C 3J7, Canada; Sainte-Justine UHC Research Center, 5757 Decelles, Montreal, H3T 1C5, Canada.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'CHU, Biostatistics unit, Clermont-Ferrand, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Université Clermont Auvergne, AME2P, F-63000, Clermont-Ferrand, France; CHU, Clermont-Ferrand, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Boirie', 'Affiliation': 'Université Clermont Auvergne, AME2P, F-63000, Clermont-Ferrand, France; CHU, Clermont-Ferrand, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thivel', 'Affiliation': 'Université Clermont Auvergne, AME2P, F-63000, Clermont-Ferrand, France; School of Psychology, University of Leeds, Leeds, UK.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.04.015']
895,32486007,No Significant Differences in Muscle Growth and Strength Development When Consuming Soy and Whey Protein Supplements Matched for Leucine Following a 12 Week Resistance Training Program in Men and Women: A Randomized Trial.,"There are conflicting reports regarding the efficacy of plant versus animal-derived protein to support muscle and strength development with resistance training. The purpose of this study was to determine whether soy and whey protein supplements matched for leucine would comparably support strength increases and muscle growth following 12 weeks of resistance training. Sixty-one untrained young men ( n  = 19) and women ( n  = 42) (18-35 year) enrolled in this study, and 48 completed the trial (17 men, 31 women). All participants engaged in supervised resistance training 3×/week and consumed 19 grams of whey protein isolate or 26 grams of soy protein isolate, both containing 2 g (grams) of leucine. Multi-level modeling indicated that total body mass (0.68 kg; 95% CI: 0.08, 1.29 kg;  p  < 0.001), lean body mass (1.54 kg; 95% CI: 0.94, 2.15 kg;  p  < 0.001), and peak torque of leg extensors (40.27 Nm; 95% CI: 28.98, 51.57 Nm,  p  < 0.001) and flexors (20.44 Nm; 95% CI: 12.10, 28.79 Nm;  p  < 0.001) increased in both groups. Vastus lateralis muscle thickness tended to increase, but this did not reach statistical significance (0.12 cm; 95% CI: -0.01, 0.26 cm;  p  = 0.08). No differences between groups were observed ( p  > 0.05). These data indicate that increases in lean mass and strength in untrained participants are comparable when strength training and supplementing with soy or whey matched for leucine.",2020,"Vastus lateralis muscle thickness tended to increase, but this did not reach statistical significance (0.12 cm; 95% CI: -0.01, 0.26 cm;  p  = 0.08).","['Sixty-one untrained young men ( n  = 19) and women ( n  = 42) (18-35 year) enrolled in this study, and 48 completed the trial (17 men, 31 women', 'untrained participants', 'Men and Women']","['Resistance Training Program', 'soy and whey protein supplements matched for leucine', 'supervised resistance training 3×/week and consumed 19 grams of whey protein isolate or 26 grams of soy protein isolate, both containing 2 g (grams) of leucine', 'Consuming Soy and Whey Protein Supplements Matched for Leucine']","['lean mass and strength', 'total body mass', 'lean body mass', 'Vastus lateralis muscle thickness', 'Muscle Growth and Strength Development', 'peak torque of leg extensors']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0677666', 'cui_str': 'soy protein isolate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",61.0,0.0891844,"Vastus lateralis muscle thickness tended to increase, but this did not reach statistical significance (0.12 cm; 95% CI: -0.01, 0.26 cm;  p  = 0.08).","[{'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Lynch', 'Affiliation': 'Department of Kinesiology, Point Loma Nazarene University, San Diego, CA 92106, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Buman', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Dickinson', 'Affiliation': 'Health Sciences, Central Washington University, Ellensburg, WA, 98926, USA.'}, {'ForeName': 'Lynda B', 'Initials': 'LB', 'LastName': 'Ransdell', 'Affiliation': 'College of Health and Human Services, Northern Arizona University, Flagstaff, AZ 86011, USA.'}, {'ForeName': 'Carol S', 'Initials': 'CS', 'LastName': 'Johnston', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Wharton', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85004, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17113871']
896,32543056,Are high fresh gas flow rates necessary during the wash-in period in low-flow anesthesia?,"In low-flow anesthesia (LFA), there is a wash-in period in which usually high fresh gas flow (FGF) rates are used to achieve the required initial concentration of anesthetic agent in the alveoli. The aim of this study was to compare the efficiency, safety and the consumption of desflurane in LFA using constant FGF (1 L/min) and conventional LFA using high FGF (4 L/min) during the wash-in period. Eighty patients, who were scheduled for elective surgery under general anesthesia with endotracheal intubation, were enrolled in the study. Wash-in was accomplished with 1 L/min FGF (50% O2, 50% air) and 18% desflurane in group 1; and by 4 L/min FGF (50% O2, 50% air) and 6% desflurane in group 2. Throughout the surgery, the vaporizer was adjusted to maintain 0.6 to 0.8 minimum alveolar concentration (MAC). The time required to reach 0.7 MAC was shorter in group 1 (160 seconds [135-181] vs 288 seconds [240-500], P < .001). In 6 patients in group 1 and 13 in group 2, vaporizer settings were adjusted to maintain 0.6 to 0.8 MAC (P = .048). Desflurane consumption in the first hour and total desflurane consumption were higher in group 2 (P < .001 and P = .012, respectively). The efficiency of anesthesia in both the first hour and in total was higher in group 1 (P < .001). It is safe, more efficient, and economical to use 1 L/min FGF during the wash-in period in LFA.",2020,The efficiency of anesthesia in both the first hour and in total was higher in group 1 (P < .001).,"['Eighty patients, who were scheduled for elective surgery under general anesthesia with endotracheal intubation, were enrolled in the study']","['desflurane', 'low-flow anesthesia (LFA']","['total desflurane consumption', 'efficiency of anesthesia', 'Desflurane consumption', 'efficiency, safety', 'time required to reach 0.7 MAC']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0293921,The efficiency of anesthesia in both the first hour and in total was higher in group 1 (P < .001).,"[{'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Arslan', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}, {'ForeName': 'Gökçe', 'Initials': 'G', 'LastName': 'Gişi', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}, {'ForeName': 'Gözen', 'Initials': 'G', 'LastName': 'Öksüz', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}, {'ForeName': 'Hafize', 'Initials': 'H', 'LastName': 'Öksüz', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Bilal', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}, {'ForeName': 'Ömer Faruk', 'Initials': 'ÖF', 'LastName': 'Boran', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}, {'ForeName': 'Feyza', 'Initials': 'F', 'LastName': 'Çalışır', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}]",The Kaohsiung journal of medical sciences,['10.1002/kjm2.12251']
897,32537853,Authors' reply re: Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy for the treatment of mild-to-moderate endometriosis: randomised controlled trial.,,2020,,['mild-to-moderate endometriosis'],['Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy'],[],"[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0018880', 'cui_str': 'Helium'}]",[],,0.0726803,,"[{'ForeName': 'Gourab', 'Initials': 'G', 'LastName': 'Misra', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Staffordshire, UK.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Sim', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Staffordshire, UK.'}, {'ForeName': 'Keira', 'Initials': 'K', 'LastName': 'Watts', 'Affiliation': 'Research and Innovation, University Hospitals of North Midlands, Royal Stoke University Hospital, Staffordshire, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Coia', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Staffordshire, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16333']
898,32546796,Physical deterioration and adaptive recovery in physically inactive breast cancer patients during adjuvant chemotherapy: a randomised controlled trial.,"Cardiorespiratory fitness is an independent risk factor for cardiovascular disease and shortened life expectancy in breast cancer survivors. This randomised controlled trial (n = 153) was designed for patients with a physically inactive lifestyle prediagnosis and concurrently referred to adjuvant chemotherapy. We compared two 12-week exercise interventions aimed at physiological and patient-reported outcomes (cardiorespiratory fitness, muscle strength, metabolic markers, physical activity, pain, fatigue), including a 39-week follow-up. A supervised hospital-based moderate to high intensity group exercise intervention was compared to an instructed home-based individual pedometer intervention. The two 12-week interventions included oncologists' recommendations and systematic health counselling. Outcomes were measured at baseline and week 6, 12 and 39. Primary outcome cardiorespiratory fitness declined significantly during chemotherapy and was restored in both interventions at follow-up. The interventions effectively engaged breast cancer patients in sustaining physical activities during and following adjuvant treatment. A composite metabolic score improved significantly. Positive cardiorespiratory fitness responders had improved clinical effects on fatigue, pain and dyspnoea versus negative responders. We conclude that a loss of cardiorespiratory fitness among physically inactive breast cancer patients may be restored by early initiated interventions and by adapting to physical activity recommendations, leading to a decreased cardiovascular risk profile in breast cancer survivors.",2020,"Positive cardiorespiratory fitness responders had improved clinical effects on fatigue, pain and dyspnoea versus negative responders.","['breast cancer survivors', 'physically inactive breast cancer patients']","['adjuvant chemotherapy', 'physically inactive lifestyle prediagnosis and concurrently referred to adjuvant chemotherapy', 'supervised hospital-based moderate to high intensity group exercise intervention was compared to an instructed home-based individual pedometer intervention', ""oncologists' recommendations and systematic health counselling""]","['composite metabolic score', 'outcomes (cardiorespiratory fitness, muscle strength, metabolic markers, physical activity, pain, fatigue', 'fatigue, pain and dyspnoea', 'Physical deterioration and adaptive recovery', 'cardiorespiratory fitness']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0509229,"Positive cardiorespiratory fitness responders had improved clinical effects on fatigue, pain and dyspnoea versus negative responders.","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Møller', 'Affiliation': 'The University Hospitals Centre for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet, Department, 9701, Copenhagen, Denmark. tommoel@icloud.com.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Andersen', 'Affiliation': 'The University Hospitals Centre for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet, Department, 9701, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lillelund', 'Affiliation': 'The University Hospitals Centre for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet, Department, 9701, Copenhagen, Denmark.'}, {'ForeName': 'Kira', 'Initials': 'K', 'LastName': 'Bloomquist', 'Affiliation': 'The University Hospitals Centre for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet, Department, 9701, Copenhagen, Denmark.'}, {'ForeName': 'Karl Bang', 'Initials': 'KB', 'LastName': 'Christensen', 'Affiliation': 'University of Copenhagen, Faculty of Health and Medical Sciences, Department of Public Health, Copenhagen, Denmark.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Ejlertsen', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Department of Oncology, 7301, Copenhagen, Denmark.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Tuxen', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Department of Oncology, 7301, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Oturai', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET, Copenhagen, Denmark.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Breitenstein', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Department of Oncology, 7301, Copenhagen, Denmark.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Kolind', 'Affiliation': 'Copenhagen University Hospital, Herlev Hospital, Department of Oncology, Herlev, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Travis', 'Affiliation': 'Copenhagen University Hospital, Herlev Hospital, Department of Oncology, Herlev, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Bjerg', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Department of Oncology, 7301, Copenhagen, Denmark.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Rørth', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Department of Oncology, 7301, Copenhagen, Denmark.'}, {'ForeName': 'Lis', 'Initials': 'L', 'LastName': 'Adamsen', 'Affiliation': 'The University Hospitals Centre for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet, Department, 9701, Copenhagen, Denmark.'}]",Scientific reports,['10.1038/s41598-020-66513-9']
899,32559335,Phase II Study of Low-Dose Afatinib Maintenance Treatment Among Patients with EGFR-Mutated Non-Small Cell Lung Cancer: North Japan Lung Cancer Study Group Trial 1601 (NJLCG1601).,"LESSONS LEARNED


Low-dose afatinib maintenance treatment among patients with EGFR-mutated NSCLC achieved long-time to treatment failure with fewer treatment-related AEs without detracting from the therapeutic efficacy. This modified regimen represents a practical usage that balances effectiveness and safety.
BACKGROUND


Although afatinib is an effective therapy for patients with EGFR-mutated non-small cell lung cancer (NSCLC), drug-related adverse events (AEs) have often necessitated dose reductions. In a post hoc analysis of the LUX-Lung 3 and 6 trials, there was no difference in median progression-free survival (PFS) between patients who had the dose of afatinib reduced and those who did not. We thus evaluated the efficacy and tolerability of low-dose afatinib maintenance treatment among patients with NSCLC harboring EGFR mutations who had not been previously treated.
METHODS


Eligible patients received afatinib 40 mg orally once daily. When prescribed grade ≥ 2 AEs, rash of grade ≥ 3, or unacceptable toxicity occurred, the afatinib dose was reduced from 40 to 30 mg and if needed from 30 to 20 mg. The primary endpoint was the 1-year PFS rate. Secondary endpoints were PFS, overall response rate (ORR), and toxicity.
RESULTS


Among 30 patients, 93% had adenocarcinoma, 53% had exon 19 deletion, 37% had L858R, and 10% had minor mutations. The 1-year PFS rate was 50% (95% confidence interval [CI], 31.3-66.1) and the median PFS was 11.8 months (95% CI, 7.1-21.4). The incidence rate of grade ≥ 3 toxicities was 57%, including elevated aspartate aminotransferase/alanine aminotransferase level (13%), diarrhea (10%), and paronychia (10%).
CONCLUSION


Low-dose afatinib maintenance treatment reduced treatment-related AEs without detracting from the therapeutic efficacy.",2020,"The 1-year PFS rate was 50% (95% confidence interval [CI], 31.3-66.1) and the median PFS was 11.8 months (95% CI, 7.1-21.4).","['Eligible patients received', 'patients with EGFR-mutated non-small cell lung cancer (NSCLC', 'patients with EGFR-mutated NSCLC', 'Patients with EGFR-Mutated Non-Small Cell Lung Cancer', 'patients with NSCLC harboring EGFR mutations who had not been previously treated']","['afatinib 40 mg orally once daily', 'Low-Dose Afatinib Maintenance Treatment']","['diarrhea', 'incidence rate of grade ≥\u20093 toxicities', 'paronychia', '1-year PFS rate', 'PFS, overall response rate (ORR), and toxicity', 'elevated aspartate aminotransferase/alanine aminotransferase level', 'efficacy and tolerability', 'median progression-free survival (PFS', 'unacceptable toxicity', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C3652037', 'cui_str': 'Afatinib 40 MG [Gilotrif]'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0030578', 'cui_str': 'Paronychia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.240061,"The 1-year PFS rate was 50% (95% confidence interval [CI], 31.3-66.1) and the median PFS was 11.8 months (95% CI, 7.1-21.4).","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Department of Respiratory Medicine, Hirosaki University, Hirosaki, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Saito', 'Affiliation': 'Department of Respiratory Medicine, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Suzuki', 'Affiliation': 'Department of Respiratory Medicine, Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Department of Respiratory Medicine, JCHO Hokkaido Hospital, Sapporo, Japan.'}, {'ForeName': 'Sumito', 'Initials': 'S', 'LastName': 'Inoue', 'Affiliation': 'Department of Cardiology, Pulmonology, and Nephrology, Yamagata University Faculty of Medicine, Yamagata, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'First Department of Internal Medicine, Toyama University Hospital, Toyama, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Nakagawa', 'Affiliation': 'Dapartment of Thoracic Surgery, Omagari Kosei Medical Center, Daisen, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Jingu', 'Affiliation': 'Department of Respiratory Medicine, Saka General Hospital, Shiogama, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.'}]",The oncologist,['10.1634/theoncologist.2020-0545']
900,32567234,"The impact of negative-pressure wound therapy with instillation on wounds requiring operative debridement: Pilot randomised, controlled trial.","Presence of bacteria in wounds can delay healing. Addition of a regularly instilled topical solution over the wound during negative-pressure wound therapy (NPWT) may reduce bioburden levels compared with standard NPWT alone. We performed a prospective, randomised, multi-centre, post-market trial to compare effects of NPWT with instillation and dwell of polyhexamethylene biguanide solution vs NPWT without instillation therapy in wounds requiring operative debridement. Results showed a significantly greater mean decrease in total bacterial counts from time of initial surgical debridement to first dressing change in NPWT plus instillation (n = 69) subjects compared with standard NPWT (n = 63) subjects (-0.18 vs 0.6 log 10  CFU/g, respectively). There was no significant difference between the groups in the primary endpoint of required inpatient operating room debridements after initial debridement. Time to readiness for wound closure/coverage, proportion of wounds closed, and incidence of wound complications were similar. NPWT subjects had 3.1 times the risk of re-hospitalisation compared with NPWT plus instillation subjects. This study provides a basis for exploring research options to understand the impact of NPWT with instillation on wound healing.",2020,NPWT subjects had 3.1 times the risk of re-hospitalisation compared with NPWT plus instillation subjects.,['wounds requiring operative debridement'],"['negative-pressure wound therapy with instillation', 'NPWT with instillation and dwell of polyhexamethylene biguanide solution vs NPWT without instillation therapy', 'standard NPWT', 'negative-pressure wound therapy (NPWT']","['total bacterial counts', 'bioburden levels', 'Time to readiness for wound closure/coverage, proportion of wounds closed, and incidence of wound complications', 'risk of re-hospitalisation']","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0376892', 'cui_str': 'polihexanide'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",69.0,0.0491176,NPWT subjects had 3.1 times the risk of re-hospitalisation compared with NPWT plus instillation subjects.,"[{'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Kim', 'Affiliation': 'Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Lavery', 'Affiliation': 'Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Galiano', 'Affiliation': 'Northwestern Memorial Hospital, Chicago, Illinois, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Salgado', 'Affiliation': 'University of Miami Health System, Miami, Florida, USA.'}, {'ForeName': 'Dennis P', 'Initials': 'DP', 'LastName': 'Orgill', 'Affiliation': ""Division of Plastic Surgery, Brigham & Women's Hospital Wound Care Center, Boston, Massachusetts, USA.""}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Kovach', 'Affiliation': 'Penn Plastic Surgery University City, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Brent H', 'Initials': 'BH', 'LastName': 'Bernstein', 'Affiliation': ""St. Luke's University Health Network, Bethlehem, Pennsylvania, USA.""}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Attinger', 'Affiliation': 'Department of Plastic Surgery, MedStar Georgetown University Hospital, Washington, District of Columbia, USA.'}]",International wound journal,['10.1111/iwj.13424']
901,32564453,Profiling ocular surface responses to preserved and non-preserved topical glaucoma medications: A 2-year randomized evaluation study.,"BACKGROUND


Use of topical glaucoma medications has been reported to cause ocular surface (OS) discomfort and inflammation. This study explores the profile of inflammatory cytokines and OS symptoms induced in response to preserved and non-preserved drops.
METHODS


Prospective, randomized evaluation on 36 treatment-naïve patients over 24 months of three differently preserved glaucoma drop preparations: Preservative-free (PF), polyquad (PQ) and benzalkonium chloride (BAK). Study participants were evaluated at baseline and then at 1, 3, 6, 12 and 24 months while on medication. At each visit, participants completed the OS disease index (OSDI) questionnaire, had basal tear sampling and impression cytology (IC) of the conjunctival epithelium. Quantitative polymerase chain reaction was performed to measure the gene expression of inflammatory cytokines [interleukin (IL)-6, IL-8, IL-10, IL-12A, IL-12B, IL-17A, IL-1β and tumour necrosis factor-α] in the IC samples. Corresponding protein expression of cytokines in tear samples was assessed by the Becton-Dickinson cytometric bead arrays.
RESULTS


Compared to PF and PQ groups, mRNA and protein expression of IL-6, IL-8 and IL-1β increased in samples from the BAK group in a time-dependent fashion, whereas all other cytokines showed a non-significant increase. In the BAK group, there was a strong correlation between OSDI and the levels of IC/IL-1β (r = .832, R 2  = .692 and P = .040); IC/IL-10 (r = .925, R 2  = .856 and P = .008) and tear/IL-1β (r = .899, R 2  = .808 and P = .014).
CONCLUSIONS


BAK-preserved topical drops stimulate a sterile inflammatory response on the OS within 3 months which is maintained thereafter, whereas PF-drops and PQ-preserved drops showed no significant OS inflammation.",2020,"In the BAK group, there was a strong correlation between OSDI and the levels of IC/IL-1β (r=0.832, R squared=0.692 and p=0.040); IC/IL-10 (r=0.925, R squared=0.856 and p=0.008) and tear/IL-1β",['thirty-six treatment-naïve patients over 24 months of three differently preserved glaucoma drop preparations'],"['Preservative-free (PF), Polyquad (PQ), and Benzalkonium chloride (BAK']","['mRNA and protein expression of IL-6, IL-8, and IL-1β', 'tear/IL-1β', 'OSDI and the levels of IC/IL-1β', 'OS inflammation', 'gene expression of inflammatory cytokines (Interleukin (IL)-6, IL-8, IL-10, IL-12A, IL-12B, IL-17A, IL-1β, and tumour necrosis factor (TNF)-α', 'Ocular Surface disease index (OSDI) questionnaire, had basal tear sampling and impression cytology (IC) of the conjunctival epithelium']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}]","[{'cui': 'C0033086', 'cui_str': 'Drug preservative'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0071668', 'cui_str': 'polyquaternium 1'}, {'cui': 'C0005026', 'cui_str': 'Benzalkonium chloride'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1121403', 'cui_str': 'IL-12p35'}, {'cui': 'C1099914', 'cui_str': 'IL12B protein, human'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0014609', 'cui_str': 'Epithelium'}]",,0.0697721,"In the BAK group, there was a strong correlation between OSDI and the levels of IC/IL-1β (r=0.832, R squared=0.692 and p=0.040); IC/IL-10 (r=0.925, R squared=0.856 and p=0.008) and tear/IL-1β","[{'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Mohammed', 'Affiliation': 'Academic Ophthalmology, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Bina', 'Initials': 'B', 'LastName': 'Kulkarni', 'Affiliation': 'Academic Ophthalmology, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Lana A', 'Initials': 'LA', 'LastName': 'Faraj', 'Affiliation': 'Academic Ophthalmology, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Abbas', 'Affiliation': 'Academic Ophthalmology, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Harminder S', 'Initials': 'HS', 'LastName': 'Dua', 'Affiliation': 'Academic Ophthalmology, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'King', 'Affiliation': 'Academic Ophthalmology, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}]",Clinical & experimental ophthalmology,['10.1111/ceo.13814']
902,32569258,Clearance of Mycoplasma genitalium and Trichomonas vaginalis Among Adolescents and Young Adults With Pelvic Inflammatory Disease: Results From the Tech-N Study.,"Current pelvic inflammatory disease (PID) treatment effectively treats Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT). However, coverage may be inadequate for Mycoplasma genitalium (MG)/Trichomonas vaginalis (TV) infections. We compared the longitudinal MG and TV outcomes with NG/CT outcomes for women enrolled in a longitudinal randomized controlled trial to optimize outcomes after PID. The prevalences of CT and NG were lower at 30- and 90-day follow-up compared with the prevalence at the time of diagnosis. No significant difference was observed for MG (odds ratio, 0.95; 0.86-1.04; P = 0.265) and TV (odds ratio, 0.89; 0.75-1.04; P = 0.146) over time for both treatment groups, showing that persistence and/or reinfection with MG and TV occurs more frequently than with CT or NG after treatment of PID using current national treatment guidelines.",2020,The prevalence of CT and NG were lower at 30 days and 90 days follow-up compared to the prevalence at time of diagnosis.,['VAGINALIS AMONG ADOLESCENTS AND YOUNG ADULTS WITH PELVIC INFLAMMATORY DISEASE'],['CT'],['prevalence of CT and NG'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0242172', 'cui_str': 'Female pelvic inflammatory disease'}]","[{'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C0027573', 'cui_str': 'Neisseria gonorrhoeae'}]",,0.0621644,The prevalence of CT and NG were lower at 30 days and 90 days follow-up compared to the prevalence at time of diagnosis.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Trent', 'Affiliation': 'From the Departments of Pediatrics.'}, {'ForeName': 'Hasiya E', 'Initials': 'HE', 'LastName': 'Yusuf', 'Affiliation': 'From the Departments of Pediatrics.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Perin', 'Affiliation': 'From the Departments of Pediatrics.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Anders', 'Affiliation': 'From the Departments of Pediatrics.'}, {'ForeName': 'Shang-En', 'Initials': 'SE', 'LastName': 'Chung', 'Affiliation': 'From the Departments of Pediatrics.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tabacco-Saeed', 'Affiliation': 'From the Departments of Pediatrics.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Rowell', 'Affiliation': 'From the Departments of Pediatrics.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Huettner', 'Affiliation': 'From the Departments of Pediatrics.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rothman', 'Affiliation': 'Adult Emergency Medicine.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Butz', 'Affiliation': 'From the Departments of Pediatrics.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Gaydos', 'Affiliation': 'Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001221']
903,32577707,Effect of fluoride varnish with functionalized tri-calcium phosphate on post-orthodontic white spot lesions: an investigator-blinded controlled trial.,"OBJECTIVE


To investigate the effect of a 5% sodium fluoride varnish with functionalized tri-calcium phosphate (fTCP) on post-orthodontic white spot lesions. A secondary aim was to study if the patients and their clinicians perceived clinical improvements.
METHOD AND MATERIALS


Fifty-nine patients with at least two visible WSLs on their maxillary incisors, canines, or first premolars present at the debonding of fixed appliances (baseline) were enrolled and assigned to a Varnish group (Clinpro White Varnish, 3M Espe) receiving topical applications at baseline and after 8 weeks, or a Control group treated with a fluoride-free mock product. The primary endpoint was white spot lesion appearance after 16 weeks, assessed from photographs using the modified ICDAS white spot lesion score (0 to 3). The patients and the dental examiners rated the white spot lesions subjectively with aid of a visual analog scale.
RESULTS


Fifty-seven patients completed the study. After 16 weeks, 62% of the white spot lesions in the Varnish group were completely reversed (score 0) compared to 39% in the Control group. The treatment effect was statistically significant (OR 0.22; 95% CI 0.08 to 0.59, P = .003) after adjusting for baseline oral hygiene index and type of tooth. A significant correlation (P < .05) was observed between patients' and orthodontists' perception of the lesions.
CONCLUSION


The 5% sodium fluoride varnish with fTCP appeared clinically effective in reversing post-orthodontic white spot lesions 16 weeks after debonding. The patients and the clinicians agreed on the obtained esthetic improvements.",2020,"A significant correlation (P < .05) was observed between patients' and orthodontists' perception of the lesions.
","['Sixty-four patients with at least two visible WSLs on their maxillary incisors, canines, or first premolars present at the debonding of fixed appliances (baseline', 'Fifty-three patients completed the study', 'post-orthodontic white spot lesions']","['sodium fluoride varnish with fTCP', '5% sodium fluoride varnish with functionalized tri-calcium phosphate (fTCP', 'Varnish group (Clinpro White Varnish, 3M Espe) receiving topical applications at baseline and after 8 weeks, or a Control group treated with a fluoride-free mock product', 'fluoride varnish with functionalized tri-calcium phosphate']","['white spot lesion appearance', 'white spot lesions subjectively with aid of a visual analog scale', 'modified ICDAS white spot lesion score']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spots'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0006711', 'cui_str': 'calcium phosphate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0562577', 'cui_str': 'Mocking'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}]","[{'cui': 'C0043154', 'cui_str': 'Dental White Spots'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",64.0,0.103072,"A significant correlation (P < .05) was observed between patients' and orthodontists' perception of the lesions.
","[{'ForeName': 'Olympia', 'Initials': 'O', 'LastName': 'Salamara', 'Affiliation': ''}, {'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Papadimitriou', 'Affiliation': ''}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Mortensen', 'Affiliation': ''}, {'ForeName': 'Svante', 'Initials': 'S', 'LastName': 'Twetman', 'Affiliation': ''}, {'ForeName': 'Despina', 'Initials': 'D', 'LastName': 'Koletsi', 'Affiliation': ''}, {'ForeName': 'Sotiria', 'Initials': 'S', 'LastName': 'Gizani', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a44810']
904,32442971,Thick and diffuse cisternal clot independently predicts vasospasm-related morbidity and poor outcome after aneurysmal subarachnoid hemorrhage.,"OBJECTIVE


Aneurysmal subarachnoid hemorrhage (aSAH) is associated with significant morbidity and mortality. The presence of thick, diffuse subarachnoid blood may portend a worse clinical course and outcome, independently of other known prognostic factors such as age, aneurysm size, and initial clinical grade.
METHODS


In this post hoc analysis, patients with aSAH undergoing surgical clipping (n = 383) or endovascular coiling (n = 189) were pooled from the placebo arms of the Clazosentan to Overcome Neurological Ischemia and Infarction Occurring After Subarachnoid Hemorrhage (CONSCIOUS)-2 and CONSCIOUS-3 randomized, double-blind, placebo-controlled phase 3 studies, respectively. Patients without and with thick, diffuse SAH (≥ 4 mm thick and involving ≥ 3 basal cisterns) on admission CT scans were compared. Clot size was centrally adjudicated. All-cause mortality and vasospasm-related morbidity at 6 weeks and Glasgow Outcome Scale-Extended (GOSE) scores at 12 weeks after aSAH were assessed. The effect of the thick and diffuse cisternal aSAH on vasospasm-related morbidity and mortality, and on poor clinical outcome at 12 weeks, was evaluated using logistic regression models.
RESULTS


Overall, 294 patients (51.4%) had thick and diffuse aSAH. Compared to patients with less hemorrhage burden, these patients were older (median age 55 vs 50 years) and more often had World Federation of Neurosurgical Societies (WFNS) grade III-V SAH at admission (24.1% vs 16.5%). At 6 weeks, all-cause mortality and vasospasm-related morbidity occurred in 36.1% (95% CI 30.6%-41.8%) of patients with thick, diffuse SAH and in 14.7% (95% CI 10.8%-19.5%) of those without thick, diffuse SAH. Individual event rates were 7.5% versus 2.5% for all-cause death, 19.4% versus 6.8% for new cerebral infarct, 28.2% versus 9.4% for delayed ischemic neurological deficit, and 24.8% versus 10.8% for rescue therapy due to cerebral vasospasm, respectively. Poor clinical outcome (GOSE score ≥ 4) was observed in 32.7% (95% CI 27.3%-38.3%) and 16.2% (95% CI 12.1%-21.1%) of patients with and without thick, diffuse SAH, respectively.
CONCLUSIONS


In a large, centrally adjudicated population of patients with aSAH, WFNS grade at admission and thick, diffuse SAH independently predicted vasospasm-related morbidity and poor 12-week clinical outcome. Patients with thick, diffuse cisternal SAH may be an important cohort to target in future clinical trials of treatment for vasospasm.",2020,All-cause mortality and vasospasm-related morbidity at 6 weeks and Glasgow Outcome Scale-Extended (GOSE) scores at 12 weeks after aSAH were assessed.,"['After Subarachnoid Hemorrhage', 'Patients with thick, diffuse cisternal', 'patients with aSAH undergoing surgical clipping (n = 383) or', '294 patients (51.4%) had thick and diffuse aSAH']","['Clazosentan', 'endovascular coiling', 'placebo']","['Clot size', 'Individual event rates', 'World Federation of Neurosurgical Societies (WFNS) grade III-V SAH at admission', 'Neurological Ischemia and Infarction Occurring', 'All-cause mortality and vasospasm-related morbidity at 6 weeks and Glasgow Outcome Scale-Extended (GOSE) scores', 'mortality and vasospasm-related morbidity', 'delayed ischemic neurological deficit', 'admission CT scans']","[{'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C1721268', 'cui_str': 'clazosentan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0036001', 'cui_str': 'S-Adenosyl homocysteine'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4285772', 'cui_str': 'Delayed ischaemic neurological deficit'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]",189.0,0.207046,All-cause mortality and vasospasm-related morbidity at 6 weeks and Glasgow Outcome Scale-Extended (GOSE) scores at 12 weeks after aSAH were assessed.,"[{'ForeName': 'E François', 'Initials': 'EF', 'LastName': 'Aldrich', 'Affiliation': '1Department of Neurosurgery, University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Higashida', 'Affiliation': '2Department of Neurointerventional Radiology, University of California San Francisco Medical Center, San Francisco, California.'}, {'ForeName': 'Abdel', 'Initials': 'A', 'LastName': 'Hmissi', 'Affiliation': '3Global Clinical Development, Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Le', 'Affiliation': '1Department of Neurosurgery, University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'R Loch', 'Initials': 'RL', 'LastName': 'Macdonald', 'Affiliation': '4Department of Neurological Surgery, University of California San Francisco, Fresno, California.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Marr', 'Affiliation': '3Global Clinical Development, Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Stephan A', 'Initials': 'SA', 'LastName': 'Mayer', 'Affiliation': '6Department of Neurology, Henry Ford Neuroscience Institute, Wayne State School of Medicine, Detroit, Michigan; and.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Roux', 'Affiliation': '3Global Clinical Development, Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bruder', 'Affiliation': '7Department of Anesthesia and Critical Care, Hôpital de la Timone, Aix-Marseille Université, Marseille, France.'}]",Journal of neurosurgery,['10.3171/2020.3.JNS193400']
905,32446245,"Me, myself, bye: regional alterations in glutamate and the experience of ego dissolution with psilocybin.","There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression. Accumulating preclinical evidence emphasizes the role of the glutamate system in the acute action of the drug on brain and behavior; however this has never been tested in humans. Following a double-blind, placebo-controlled, parallel group design, we utilized an ultra-high field multimodal brain imaging approach and demonstrated that psilocybin (0.17 mg/kg) induced region-dependent alterations in glutamate, which predicted distortions in the subjective experience of one's self (ego dissolution). Whereas higher levels of medial prefrontal cortical glutamate were associated with negatively experienced ego dissolution, lower levels in hippocampal glutamate were associated with positively experienced ego dissolution. Such findings provide further insights into the underlying neurobiological mechanisms of the psychedelic, as well as the baseline, state. Importantly, they may also provide a neurochemical basis for therapeutic effects as witnessed in ongoing clinical trials.",2020,"There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression.",[],"['psilocybin', 'placebo']","['medial prefrontal cortical glutamate', 'hippocampal glutamate']",[],"[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}]",,0.0862072,"There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression.","[{'ForeName': 'N L', 'Initials': 'NL', 'LastName': 'Mason', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. natasha.mason@maastrichtuniversity.nl.'}, {'ForeName': 'K P C', 'Initials': 'KPC', 'LastName': 'Kuypers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Reckweg', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'D H Y', 'Initials': 'DHY', 'LastName': 'Tse', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Toennes', 'Affiliation': 'Institute of Legal Medicine, University of Frankfurt, Kennedyallee 104, D-60596, Frankfurt/Main, Germany.'}, {'ForeName': 'N R P W', 'Initials': 'NRPW', 'LastName': 'Hutten', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'J F A', 'Initials': 'JFA', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center+ (MUMC+), Maastricht, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stiers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Feilding', 'Affiliation': 'The Beckley Foundation, Beckley Park, Oxford, OX3 9SY, UK.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. j.ramaekers@maastrichtuniversity.nl.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0718-8']
906,32247794,Subperiosteal versus Subdural Drain After Burr-hole Drainage Under Blood Thinners: A Subanalysis of the cSDH-Drain RCT.,"OBJECTIVE


The chronic subdural hematoma (cSDH)-Drain trial compared recurrence rates and clinical outcome associated with the use of subperiosteal drain (SPD) and subdural drain (SDD) after burr-hole drainage for cSDH. This subgroup analysis aimed to determine whether one drain type is preferable for patients treated with platelet inhibitors (PI) or anticoagulants (AC).
METHODS


This subanalysis included 133 patients treated with PI/AC of the 220 patients from the preceding cSDH-Drain trial. For these patients the association between the drain type used and recurrence rates, mortality, as well as clinical outcome at 6 weeks and 12 months follow-up were analyzed using a logistic regression analysis model. Additionally, recurrence rates, clinical outcome, and mortality were assessed for each PI or AC type separately.
RESULTS


The insertion of SPD was associated with 7.35% recurrence rates compared to 13.85% with SDD in patients treated with PI or AC (OR 0.41, 95% CI 0.06-2.65, P = 0.36). Outcome measurements and mortality did not differ significantly between both groups at 6-week and 12-month follow-up. In addition, there was no statistically significant association between drain type and recurrence rate or mortality when comparing data for each PI or AC type. At 24 hours postoperatively, significantly more patients under phenprocoumon and natrium-dalteparin had a Glasgow Coma Scale score between 13 and 15 in the SDD group compared with the SPD group (P = 0.006), whereaas at 6-week follow-up significantly more patients in the SDD group treated with ASA had a good modified Rankin scale score (P = 0.01). At 12 months, no significant difference in outcome measurements was seen for all PI and AC types.
CONCLUSIONS


In patients treated with PI or AC, the insertion of SPD after burr-hole drainage of cSDH showed comparable recurrence, mortality, and long term outcome rates when compared with SDD.",2020,"The insertion of SPD was associated with 7.35% recurrence rates compared to 13.85% with SDD in patients treated with PI or AC (OR 0.41, 95% CI 0.06-2.65, P = 0.36).","['133 patients treated with PI/AC of the 220 patients from the preceding cSDH-Drain trial', 'After Burr-hole Drainage Under Blood Thinners']","['Subperiosteal versus Subdural Drain', 'ASA', 'subperiosteal drain (SPD) and subdural drain (SDD', 'cSDH-Drain RCT', 'platelet inhibitors (PI) or anticoagulants (AC']","['good modified Rankin scale score', 'Glasgow Coma Scale score', 'recurrence, mortality', 'recurrence rates, mortality', 'mortality', 'recurrence rates', 'recurrence rates, clinical outcome, and mortality', 'drain type and recurrence rate or mortality']","[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0032188', 'cui_str': 'Platelet Inhibitors'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0749095', 'cui_str': 'Subdural Hematoma, Chronic'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0040836', 'cui_str': 'Trephination of cranium'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0038541', 'cui_str': 'Subdural space structure'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0749095', 'cui_str': 'Subdural Hematoma, Chronic'}, {'cui': 'C0032188', 'cui_str': 'Platelet Inhibitors'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",220.0,0.201965,"The insertion of SPD was associated with 7.35% recurrence rates compared to 13.85% with SDD in patients treated with PI or AC (OR 0.41, 95% CI 0.06-2.65, P = 0.36).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kamenova', 'Affiliation': 'Department of Neurosurgery, University Hospital of Basel, Basel, Switzerland.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Lutz', 'Affiliation': 'Faculty of Medicine, University of Basel, Basel, Switzerland; Department of Neurosurgery, Inselspital Bern, Bern, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schaedelin', 'Affiliation': 'Clinical Trial Unit, University of Basel, Switzerland.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Fandino', 'Affiliation': 'Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Mariani', 'Affiliation': 'Department of Neurosurgery, University Hospital of Basel, Basel, Switzerland; Faculty of Medicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Jehuda', 'Initials': 'J', 'LastName': 'Soleman', 'Affiliation': 'Department of Neurosurgery, University Hospital of Basel, Basel, Switzerland; Faculty of Medicine, University of Basel, Basel, Switzerland. Electronic address: jehuda.soleman@gmail.com.'}]",World neurosurgery,['10.1016/j.wneu.2020.03.134']
907,32453167,Infraglottic versus supraglottic jet-ventilation for endobronchial ultrasound-guided transbronchial needle aspiration: A randomised controlled trial.,"BACKGROUND


For endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) under general anaesthesia, both rigid bronchoscopy and laryngeal masks (LMAs) with superimposed high-frequency jet ventilation can be used. Despite the fact that in Europe rigid bronchoscopy for EBUS-TBNA is still widely used, an increasing number of centres use jet ventilation via the LMA for this procedure. To our knowledge no clinical trials have ever been made to compare these two methods. This trial aimed to evaluate whether patients recover from the procedure more quickly when a LMA is used for ventilation compared with rigid bronchoscopy where muscle relaxants and deep anaesthesia are required.
OBJECTIVES


We wanted to test the hypothesis that there is no difference in the postoperative recovery of patients in the postanaesthesia care unit (PACU) after EBUS-TBNA with jet ventilation via a rigid bronchoscope and a LMA. Secondary outcomes were the difference of duration of anaesthesia, the diagnostic outcome of the procedure and drug quantities for both groups.
DESIGN


Prospective randomised single blinded two centre controlled trial.
SETTING


Two centres in Austria participated. Patients were enrolled from December 2016 until January 2018.
PATIENTS


Ninety patients for elective EBUS-TBNA were enrolled and assigned to one of two intervention groups. Two patients were excluded before and eleven patients were excluded after EBUS-TBNA. Seventy-seven were analysed.
INTERVENTIONS


Patients assigned to group 1 were ventilated with a LMA; those assigned to group 2 were ventilated via a rigid bronchoscope. Vital signs, drug dosage, duration of anaesthesia, recovery, PACU stay and Aldrete score at the PACU were recorded.
MAIN OUTCOME MEASURES


The primary endpoint was an integral over time of a modified Aldrete score. Secondary endpoints were the durations of the interventions, the recovery from anaesthesia and PACU stay, initial and mean Aldrete values at PACU, the effect site concentration of Propofol according to the Schnider pharmacokinetic model, the peak ultiva rates and the diagnostic outcome.
RESULTS


We were not able to show any significant difference regarding the postoperative recovery criteria based on the Aldrete score, the durations measured and the diagnostic outcomes. Vital signs remained stable and in an equal range in both groups. There were no differences in the mean effect site propofol concentration and the peak ultiva rates.
CONCLUSION


EBUS-TBNA under general anaesthesia using a LMA with SHJV is equal to rigid bronchoscopy with superimposed high-frequency jet ventilation for the variables analysed.
TRIAL REGISTRATION


ISRCTN (ISRCTN58911367).",2020,"We were not able to show any significant difference regarding the postoperative recovery criteria based on the Aldrete score, the durations measured and the diagnostic outcomes.","['Patients were enrolled from December 2016 until January 2018', 'Seventy-seven were analysed', 'Ninety patients for elective EBUS-TBNA', 'Two patients were excluded before and eleven patients were excluded after EBUS-TBNA', 'Two centres in Austria participated']","['ventilated via a rigid bronchoscope', 'endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA', 'LMA with SHJV', 'endobronchial ultrasound-guided transbronchial needle aspiration', 'Infraglottic versus supraglottic jet-ventilation', 'LMA']","['Vital signs, drug dosage, duration of anaesthesia, recovery, PACU stay and Aldrete score at the PACU', 'mean effect site propofol concentration and the peak ultiva rates', 'integral over time of a modified Aldrete score', 'durations of the interventions, the recovery from anaesthesia and PACU stay, initial and mean Aldrete values at PACU, the effect site concentration of Propofol according to the Schnider pharmacokinetic model, the peak ultiva rates and the diagnostic outcome', 'duration of anaesthesia, the diagnostic outcome of the procedure and drug quantities for both groups']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004348', 'cui_str': 'Austria'}]","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0179435', 'cui_str': 'Rigid bronchoscope'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0442192', 'cui_str': 'Supraglottic'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1821424', 'cui_str': 'Post Anesthetic Recovery score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0594510', 'cui_str': 'Ultiva'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3164884', 'cui_str': 'Modified Aldrete score'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",2.0,0.127212,"We were not able to show any significant difference regarding the postoperative recovery criteria based on the Aldrete score, the durations measured and the diagnostic outcomes.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Anwar', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fritze', 'Affiliation': ''}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Base', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wasserscheid', 'Affiliation': ''}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Wolfram', 'Affiliation': ''}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Koinig', 'Affiliation': ''}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hackner', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lambers', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schweiger', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Errhalt', 'Affiliation': ''}, {'ForeName': 'Mir A', 'Initials': 'MA', 'LastName': 'Hoda', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001220']
908,32454920,"Perioperative Dexmedetomidine Fails to Improve Postoperative Analgesic Consumption and Postoperative Recovery in Patients Undergoing Lateral Thoracotomy for Thoracic Esophageal Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial.","Objectives


Dexmedetomidine is widely used as an adjunct to general anesthesia. In this study, we evaluated the effects of perioperative dexmedetomidine infusion on postoperative analgesia in patients undergoing lateral thoracotomy for thoracic esophageal cancer.
Methods


A total of 62 patients undergoing lateral thoracotomy for thoracic esophageal cancer were randomized to receive adjuvant therapy with either dexmedetomidine (0.5  μ g/kg intravenous bolus injection for 10 min before induction of anesthesia, followed by continuous infusion of 0.2-0.4  μ g/kg/h until the end of surgery, and 0.06  μ g/kg/h for 5 days after surgery) or equal volumes of saline. Acute postoperative pain was treated with patient-controlled intravenous sufentanil and flurbiprofen axetil. The primary outcomes of this study were the numbers of analgesic requirements in the first postoperative 72 h.
Results


Perioperative dexmedetomidine did not decrease the numbers of analgesic requirements in the first postoperative 72 h (dexmedetomidine group: 12.14 ± 4.76, saline group: 10.89 ± 5.66;  p =0.367). Likewise, the groups did not differ with respect to total postoperative analgesic requirements, postoperative pain, perioperative inflammation, blood cell count, incidence of adverse events, surgical recovery (assessed at postoperative days 2 and 5 using the surgical recovery scale), length of hospital stay, hospital cost, incidence of chronic pain, or quality of life. Notably, dexmedetomidine had beneficial effects on decreasing intraoperative opioid consumption and improving postoperative sleep quality.  Discussion . Perioperative dexmedetomidine has limited analgesic benefits in lateral thoracotomy for esophageal cancer when added to an opioid-based multimodal anesthetic regimen but can reduce opioid consumption.",2020,"Likewise, the groups did not differ with respect to total postoperative analgesic requirements, postoperative pain, perioperative inflammation, blood cell count, incidence of adverse events, surgical recovery (assessed at postoperative days 2 and 5 using the surgical recovery scale), length of hospital stay, hospital cost, incidence of chronic pain, or quality of life.","['62 patients undergoing lateral thoracotomy for thoracic esophageal cancer', 'Patients Undergoing Lateral Thoracotomy for Thoracic Esophageal Cancer', 'patients undergoing lateral thoracotomy for thoracic esophageal cancer']","['Placebo', 'flurbiprofen axetil', 'sufentanil', 'Dexmedetomidine', 'Perioperative Dexmedetomidine', 'Perioperative dexmedetomidine', 'perioperative dexmedetomidine infusion', 'dexmedetomidine']","['numbers of analgesic requirements', 'total postoperative analgesic requirements, postoperative pain, perioperative inflammation, blood cell count, incidence of adverse events, surgical recovery (assessed at postoperative days 2 and 5 using the surgical recovery scale), length of hospital stay, hospital cost, incidence of chronic pain, or quality of life', 'Postoperative Analgesic Consumption and Postoperative Recovery', 'postoperative sleep quality', 'Acute postoperative pain', 'intraoperative opioid consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1610514', 'cui_str': 'flurbiprofen axetil'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",62.0,0.395807,"Likewise, the groups did not differ with respect to total postoperative analgesic requirements, postoperative pain, perioperative inflammation, blood cell count, incidence of adverse events, surgical recovery (assessed at postoperative days 2 and 5 using the surgical recovery scale), length of hospital stay, hospital cost, incidence of chronic pain, or quality of life.","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Jixi Road 218, Hefei City, Anhui Province, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Jixi Road 218, Hefei City, Anhui Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Si', 'Affiliation': 'Department of Laboratory, First Affiliated Hospital of Anhui Medical University, Jixi Road 218, Hefei City, Anhui Province, China.'}, {'ForeName': 'Lijian', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Jixi Road 218, Hefei City, Anhui Province, China.'}, {'ForeName': 'Xuesheng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Jixi Road 218, Hefei City, Anhui Province, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'School of Life Sciences, University of Science and Technology of China, Huangshan Road 443, Hefei City, Anhui Province, China.'}, {'ForeName': 'Erwei', 'Initials': 'E', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Jixi Road 218, Hefei City, Anhui Province, China.'}]",Pain research & management,['10.1155/2020/4145893']
909,32457012,Metoclopramide Reduces Fluoroscopy and Procedure Time during Gastrojejunostomy Tube Placement: A Placebo-Controlled Trial.,"PURPOSE


To determine whether a single 10-mg intravenous dose of the promotility agent metoclopramide reduces the fluoroscopy time, radiation dose, and procedure time required for gastrojejunostomy (GJ) tube placement.
METHODS


This prospective, randomized, double-blind, placebo-controlled trial enrolled consecutive patients who underwent primary GJ tube placement at a single institution from April 10, 2018, to October 3, 2019. Exclusion criteria included age less than 18 years, inability to obtain consent, metoclopramide allergy or contraindication, and altered pyloric anatomy. Average fluoroscopy times, radiation doses, and procedure times were compared using t-tests. The full study protocol can be found at www.clinicaltrials.gov (NCT03331965).
RESULTS


Of 110 participants randomized 1:1, 45 received metoclopramide and 51 received placebo and underwent GJ tube placement (38 females and 58 males; mean age, 55 ± 18 years). Demographics of the metoclopramide and placebo groups were similar. The fluoroscopy time required to advance a guide wire through the pylorus averaged 1.6 minutes (range, 0.3-10.1 minutes) in the metoclopramide group versus 4.1 minutes (range, 0.2-27.3 minutes) in the placebo group (P = .002). Total procedure fluoroscopy time averaged 5.8 minutes (range, 1.5-16.2 minutes) for the metoclopramide group versus 8.8 minutes (range, 2.8-29.7 minutes) for the placebo group (P = .002). Air kerma averaged 91 mGy (range, 13-354 mGy) for the metoclopramide group versus 130 mGy (range, 24-525 mGy) for the placebo group (P = .04). Total procedure time averaged 16.4 minutes (range, 8-51 minutes) for the metoclopramide group versus 19.9 minutes (range, 6-53 minutes) for the placebo group (P = .04). There were no drug-related adverse events and no significant differences in procedure-related complications.
CONCLUSIONS


A single dose of metoclopramide reduced fluoroscopy time by 34%, radiation dose by 30%, and procedure time by 17% during GJ tube placement.",2020,"Air kerma averaged 91 mGy (range, 13-354 mGy) for the metoclopramide group versus 130 mGy (range, 24-525 mGy) for the placebo group (P = .04).","['consecutive patients who underwent primary GJ tube placement at a single institution from April 10, 2018, to October 3, 2019', '110 participants randomized 1:1, 45 received', 'Exclusion criteria included age less than 18 years, inability to obtain consent, metoclopramide allergy or contraindication, and altered pyloric anatomy', '38 females and 58 males; mean age, 55 ± 18 years']","['metoclopramide and placebo', 'Placebo', 'Metoclopramide', 'metoclopramide', 'GJ tube placement', 'placebo']","['procedure-related complications', 'fluoroscopy time, radiation dose, and procedure time required for gastrojejunostomy (GJ) tube placement', 'Total procedure time', 'Average fluoroscopy times, radiation doses, and procedure times', 'fluoroscopy time', 'Total procedure fluoroscopy time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3880870', 'cui_str': 'Gastrojejunostomy tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1532670', 'cui_str': 'Obtaining consent'}, {'cui': 'C0570599', 'cui_str': 'Allergy to metoclopramide'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034196', 'cui_str': 'Pyloric structure of stomach'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3880870', 'cui_str': 'Gastrojejunostomy tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3880870', 'cui_str': 'Gastrojejunostomy tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",110.0,0.369738,"Air kerma averaged 91 mGy (range, 13-354 mGy) for the metoclopramide group versus 130 mGy (range, 24-525 mGy) for the placebo group (P = .04).","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'DuRocher', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Tony P', 'Initials': 'TP', 'LastName': 'Smith', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gazda', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Olivas', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Whited', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Langston', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Martin', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Charles Y', 'Initials': 'CY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ronald', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710. Electronic address: james.ronald@duke.edu.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2020.02.028']
910,32587397,The effect of 17% EDTA and QMiX ultrasonic activation on smear layer removal and sealer penetration: ex vivo study.,"This study aimed to compare the effect of conventional irrigation (CI) and passive ultrasonic irrigation (PUI) with 17% EDTA and QMiX on the maximum depth and percentage of sealer penetration into the dentinal tubules by confocal laser scanning microscopy (CLSM) and to describe the cleaning of root canal walls by scanning electron microscopy (SEM). Eighty single-rooted human mandibular premolars were instrumented and randomly assigned to four groups (n = 20): EDTA + CI, QMiX + CI, EDTA + PUI, and QMiX + PUI. Ten samples from each group were examined by SEM (2,000×) and the remaining 40 roots were filled with a single gutta-percha cone and AH Plus sealer mixed with 0.1% rhodamine B for analysis by CLSM (10×). Images were assessed at distances of 2 mm (apical), 5 mm (middle), and 8 mm (coronal) from the apex with the Leica Application Suite V4.10 software. The EDTA + PUI and QMiX + PUI protocols presented higher rates of debris/smear layer removal in the apical and middle thirds. The PUI was superior to CI in the maximum depth of sealer penetration at the middle third. The QMiX + PUI group had a higher percentage of sealer penetration at the apical third. The PUI and QMiX protocol improved debris/smear layer removal and tubular dentin sealer penetration.",2020,The PUI and QMiX protocol improved debris/smear layer removal and tubular dentin sealer penetration.,"['Ten samples from each group were examined by SEM (2,000×) and the remaining 40 roots were filled with a', 'Eighty single-rooted human mandibular premolars']","['conventional irrigation (CI) and passive ultrasonic irrigation (PUI) with 17% EDTA and QMiX', '17% EDTA and QMiX ultrasonic activation', 'single gutta-percha cone and AH Plus sealer mixed with 0.1% rhodamine B for analysis by CLSM']","['sealer penetration', 'rates of debris/smear layer removal', 'debris/smear layer removal and tubular dentin sealer penetration']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0026019', 'cui_str': 'Electron microscopic study'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0440200', 'cui_str': 'Gutta percha cone'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0073194', 'cui_str': 'Rhodamine B'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0242841', 'cui_str': 'Confocal Laser Scanning Microscopy'}]","[{'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0085070', 'cui_str': 'Smear Layer'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]",80.0,0.0357585,The PUI and QMiX protocol improved debris/smear layer removal and tubular dentin sealer penetration.,"[{'ForeName': 'Felipe de Souza', 'Initials': 'FS', 'LastName': 'Matos', 'Affiliation': 'Postgraduate Program in Dentistry, School of Dentistry, Federal University of Uberlândia (UFU), Uberlândia, MG, Brazil. felipe_smatos@hotmail.com.'}, {'ForeName': 'Fabrício Rutz', 'Initials': 'FR', 'LastName': 'da Silva', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa (UEPG), Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Luiz Renato', 'Initials': 'LR', 'LastName': 'Paranhos', 'Affiliation': 'Department of Preventive and Social Dentistry, School of Dentistry, Federal University of Uberlândia (UFU), Uberlândia, MG, Brazil.'}, {'ForeName': 'Camilla Christian Gomes', 'Initials': 'CCG', 'LastName': 'Moura', 'Affiliation': 'Department of Endodontics, School of Dentistry, Federal University of Uberlândia (UFU), Uberlândia, MG, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bresciani', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University (Unesp), São José dos Campos, SP, Brazil.'}, {'ForeName': 'Marcia Carneiro', 'Initials': 'MC', 'LastName': 'Valera', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University (Unesp), São José dos Campos, SP, Brazil.'}]",Scientific reports,['10.1038/s41598-020-67303-z']
911,32590520,"Radiographical Comparison of Superior and Inferior Gluteal Vessels in ""Jackknife"" Versus Prone Positions: A Prospective, Self-Controlled Trial.","BACKGROUND


Mortality after gluteal augmentation with fat transfer techniques is extremely high. Placement of fat subcutaneously versus in the gluteal musculature, or both, are considerably debated. The purpose of this study was to radiographically show the anatomical difference in live subjects in different procedural positions: the flexed or ""Jack-knife"" versus prone positions.
METHODS


A total of ten females underwent Computerized Tomography (CT) scanning of the pelvis with venous phase run-off in both the ""Jack-knife"" and prone positions. A CT specialized radiologist then reviewed images and measured distances from the inferior and superior gluteal veins (IGV and SGV, respectively) to the skin and muscle. Three-dimensional (3D) imaging and analysis were also performed.
RESULTS


Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions. 3D modeling showed a significant reduction in the volume and SGV and IGV diameters when in the ""Jack-knife"" position.
CONCLUSIONS


When placed in the ""Jack-knife"" position for gluteal augmentation with fat transfer, extreme caution should be taken with the injecting cannula as the underlying muscle is only 2-3 centimeters deep. 3D analysis showed narrowed and reduced volume of gluteal vasculature when in the ""Jack-knife"" position; a possible indication of torsion or stretch on the vessel around the pelvic rim that could cause vein avulsion injury from the pressurized fat within the piriform space.",2020,"RESULTS


Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions.","['Jackknife"" Versus Prone Positions']","['Computerized Tomography (CT) scanning', 'flexed or ""Jack-knife"" versus prone positions']","['volume of gluteal vasculature', 'volume and SGV and IGV diameters']","[{'cui': 'C0033422', 'cui_str': 'Prone body position'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0181467', 'cui_str': 'Knife'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005839', 'cui_str': 'blood supply'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",10.0,0.0267786,"RESULTS


Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions.","[{'ForeName': 'Connor W', 'Initials': 'CW', 'LastName': 'Barnes', 'Affiliation': ''}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Ford', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Harrington', 'Affiliation': ''}, {'ForeName': 'Rajendra P', 'Initials': 'RP', 'LastName': 'Kedar', 'Affiliation': ''}, {'ForeName': 'Thanh Q', 'Initials': 'TQ', 'LastName': 'Tran', 'Affiliation': ''}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Karlnoski', 'Affiliation': ''}, {'ForeName': 'Summer J', 'Initials': 'SJ', 'LastName': 'Decker', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Smith', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007151']
912,32590521,Effect of Cyclic Compressive Forces on New Bone Formation during the Distraction Period in Mandibular Distraction Osteogenesis Using a Microactuator-Generated Distractor.,"BACKGROUND


The traditional method of distraction required a long period until the new bone was fully fused. This study aimed to evaluate the effect of cyclic and repetitive compressive force on new bone formation by applying a newly designed microactuator-generated distractor compared with the traditional distraction protocol.
METHODS


The distraction devices were applied to the right and left mandibles of eight mature beagles, four of which were allocated to the experimental group and the other four to the control group. After a 5-day latency period, in the experimental group, 1.5-mm distraction and 0.5-mm compression were alternately applied every 12 hours; and in the control group, 0.5-mm distraction was repeated every 12 hours to perform a total of 7-mm mandibular lengthening. After an 8-week consolidation period, microstructure analysis using micro-computed tomography and histologic evaluations were performed.
RESULTS


Bone volume fraction and trabecular number were significantly higher in the experimental group. Trabecular thickness did not show a significant difference, and trabecular separation was significantly higher in the control group. The measurement of new bone was significantly higher in the experimental group, but the difference in mineral apposition rate between the experimental and control groups was not statistically significant.
CONCLUSIONS


This study has revealed that applying cyclic compressive and tensile forces during the distraction period induces better new bone formation than repetitive distraction alone. In addition, the new distraction device produced reliable distraction results during the experiment.",2020,"The measurement of new bone area showed significantly higher in the experimental group, but the difference in mineral apposition rate between the experimental and control groups was not statistically significant.
",[],"['cyclic compressive forces', 'cyclic and repetitive compressive force']","['mineral apposition rate', 'measurement of new bone area', 'new bone formation', 'Bone volume fraction and trabecular number', 'Trabecular thickness', 'And trabecular separation']",[],"[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]","[{'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0334168', 'cui_str': 'New bone formation'}, {'cui': 'C0560268', 'cui_str': 'Volume fraction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0036679', 'cui_str': 'Separation'}]",,0.0166226,"The measurement of new bone area showed significantly higher in the experimental group, but the difference in mineral apposition rate between the experimental and control groups was not statistically significant.
","[{'ForeName': 'Hyun-Jin', 'Initials': 'HJ', 'LastName': 'Kwon', 'Affiliation': 'Seoul and Cheonan, Republic of Korea From the Division in Anatomy and Developmental Biology, Department of Oral Biology, Human Identification Research Institute, the Department of Orthodontics, Institute of Craniofacial Deformity, BK21 PLUS Project, and the Department of Oral and Maxillofacial Surgery, Yonsei University College of Dentistry; the Department of Anatomy, Yonsei University College of Medicine; and the Department of Oral Anatomy, Dankook University College of Dentistry.'}, {'ForeName': 'Jung-Yul', 'Initials': 'JY', 'LastName': 'Cha', 'Affiliation': ''}, {'ForeName': 'Jong-Tae', 'Initials': 'JT', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hyung Jun', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hee-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007152']
913,32552207,"Re: Long-Term Oncological Outcomes from an Early Phase Randomised Controlled Three-Arm Trial of Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL).",,2020,,[],"['Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL']",[],[],"[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0324034', 'cui_str': 'Coral'}]",[],,0.0947995,,"[{'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Cadeddu', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001166']
914,32555211,The effects of environmental enrichment on skin barrier recovery in humans: a randomised trial.,"This study investigated whether environmental enrichment (EE) could reduce stress and improve wound healing in humans. 120 participants underwent a standardised tape-stripping procedure and were then randomised to interact for 30 minutes with one of three EE interventions (comfort blankets as tactile enrichment, music as auditory enrichment or a Paro robot as multi-sensory enrichment) or to a control group. Skin barrier recovery (SBR) was measured using transepidermal water loss at baseline, after tape-stripping and after the intervention. Psychological variables, cortisol and alpha-amylase were measured at the three time-points. SBR did not significantly differ between the EE conditions and the control condition. The music condition had higher stimulation levels than the control condition, and the comfort condition had significantly lower relaxation levels than the control condition after the intervention. The EE interventions tested were not beneficial for wound healing compared to a control group. Limitations were that the sample were not stressed and an active control condition was used.",2020,SBR did not significantly differ between the EE conditions and the control condition.,"['120 participants underwent a', 'humans']","['environmental enrichment (EE', 'standardised tape-stripping procedure', 'environmental enrichment', 'EE interventions (comfort blankets as tactile enrichment, music as auditory enrichment or a Paro robot as multi-sensory enrichment) or to a control group']","['stimulation levels', 'SBR', 'skin barrier recovery', 'Skin barrier recovery (SBR', 'wound healing', 'relaxation levels', 'Psychological variables, cortisol and alpha-amylase']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0179330', 'cui_str': 'Blanket'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}]",120.0,0.0391175,SBR did not significantly differ between the EE conditions and the control condition.,"[{'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Law', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Jarrett', 'Affiliation': 'Department of Dermatology, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Urs M', 'Initials': 'UM', 'LastName': 'Nater', 'Affiliation': 'Faculty of Psychology, University of Vienna, Vienna, 1010, Austria.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Skoluda', 'Affiliation': 'Faculty of Psychology, University of Vienna, Vienna, 1010, Austria.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Broadbent', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand. e.broadbent@auckland.ac.nz.'}]",Scientific reports,['10.1038/s41598-020-66687-2']
915,32569033,Treatment for Clubfoot: Stockinette Versus Webril Cast Padding in the Ponseti Method.,"BACKGROUND


The Ponseti method of serial manipulation and casting revolutionized the treatment of one of the most common congenital orthopaedic conditions-clubfoot-resulting in less surgical morbidity and better functional results. Several studies have examined aspects of nonoperative treatment but none have explored the effect of different types of undercast padding.
METHODS


The authors performed a randomized controlled trial comparing cotton Stockinette and Webril undercast padding using the Ponseti method. They included 56 patients under the age of 6 months who had an untreated idiopathic clubfoot. For treatment, the padding was randomized to double-layer Stockinette (29 patients) or standard 2- to 3-layer Webril (27 patients). The primary analysis consisted of a 2-sample t test comparing the mean number of casts required for correction in each group. Secondary outcomes included initial and final standardized clubfoot scores (Pirani and Dimeglio scores) and adverse events.
RESULTS


Baseline demographics were not statistically different between groups, with respect to mean age, sex, and side being treated, nor were the baseline Dimeglio and Pirani scores. The primary outcome analysis revealed an equivalent number of casts (about 4) required before tenotomy. The secondary analysis on complications did not show any significant difference, with 10 events documented in the Webril group and 9 in the Stockinette group (P=1.00). At the end of the study, the mean Dimeglio (3.9±2.1 vs. 3.9±1.8, P=0.99) and Pirani (2.1±0.8 vs. 2.2±0.8, P=0.70) scores were not significantly different. Subjectively, parents and doctors indicated a substantially more positive experience for the Stockinette group.
CONCLUSIONS


Webril and Stockinette paddings provide equivalent clubfoot deformity correction while applying a similar number of casts before tenotomy. Although minor skin complications were observed, these were not significantly different between groups.",2020,"RESULTS


Baseline demographics were not statistically different between groups, with respect to mean age, sex, and side being treated, nor were the baseline Dimeglio and Pirani scores.",['56 patients under the age of 6 months who had an untreated idiopathic clubfoot'],"['double-layer Stockinette (29 patients) or standard 2- to 3-layer Webril', 'cotton Stockinette and Webril undercast padding using the Ponseti method']","['mean Dimeglio', 'equivalent number of casts (about 4) required before tenotomy', 'skin complications', 'mean number of casts required for correction', 'initial and final standardized clubfoot scores (Pirani and Dimeglio scores) and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0009081', 'cui_str': 'Talipes equinovarus'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0183614', 'cui_str': 'Stockinette'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010196', 'cui_str': 'Gossypium'}, {'cui': 'C0441601', 'cui_str': 'Padding'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0407093', 'cui_str': 'Adductor tenotomy of hip'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009081', 'cui_str': 'Talipes equinovarus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",56.0,0.130679,"RESULTS


Baseline demographics were not statistically different between groups, with respect to mean age, sex, and side being treated, nor were the baseline Dimeglio and Pirani scores.","[{'ForeName': 'Meaghan', 'Initials': 'M', 'LastName': 'Marien', 'Affiliation': ""Division of Orthopaedic Surgery, Children's Hospital of Eastern Ontario, Ottawa, ON.""}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Abouassaly', 'Affiliation': ""Division of Orthopaedic Surgery, Alberta Children's Hospital, Calgary, AL, Canada.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Jarvis', 'Affiliation': ""Division of Orthopaedic Surgery, Children's Hospital of Eastern Ontario, Ottawa, ON.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Smit', 'Affiliation': ""Division of Orthopaedic Surgery, Children's Hospital of Eastern Ontario, Ottawa, ON.""}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kontio', 'Affiliation': ""Division of Orthopaedic Surgery, Children's Hospital of Eastern Ontario, Ottawa, ON.""}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001617']
916,32579120,Elderly Medication Adherence Intervention Using the My Interventional Drug-Eluting Stent Educational App: Multisite Randomized Feasibility Trial.,"BACKGROUND


A lifesaving treatment for myocardial infarction is the placement of a stent in a closed or obstructed coronary artery. The largest modifiable risk factor after receiving a stent is medication adherence to Dual AntiPlatelet Therapy, a combination of P2Y12 inhibitors and aspirin.
OBJECTIVE


This study aimed to determine the acceptability of a protocol and an intervention using the My Interventional Drug-Eluting Stent Educational App (MyIDEA) and to evaluate medication adherence using the proportion of days covered (PDC) and platelet activation tests in a multisite randomized controlled trial.
METHODS


Potential participants who received a post percutaneous coronary intervention (PCI) procedure with a drug-eluting stent were approached. All patients older than 50 years and who spoke English were recruited. Participants were recruited, baseline demographics were collected, and the Hospital Anxiety and Depression Scale (HADS), Rapid Estimate of Adult Literacy in Medicine-Short Form, Burden-Benefit questionnaire, 36-Item Short Form Health Survey, and PCI knowledge questionnaire were administered. Block randomization was used to randomize participants to either usual care or MyIDEA supplementation. MyIDEA is a personalized educational intervention based on the Kolb experiential learning theory using patient narratives for education. During the visits, participants' blood was collected to measure platelet suppression from medication. During the second and third encounters, the Morisky medication adherence score and cardiology outcomes were measured. The study was conducted at the University of Illinois Hospital and John H Stroger Jr Cook County Hospital with appropriate ethical approvals. Platelet suppression was measured through aspirin reactive units and P2Y12 reactive units. Medication adherence was measured using the PDC. The analysis team was blinded to the participants' group membership. The primary outcome was a feasibility analysis of recruitment and retention.
RESULTS


The mean age of participants was 60.4 years (SD 7.1); the majority of patients were black and non-Hispanic. The majority of patients' reading levels were seventh grade or above, and they were not very familiar with other electronic devices for information and communication. The number of control subjects was 21, and the number of participants in the interventional arm was 24. The interventional group was able to use MyIDEA in both the hospital and outpatient setting. However, there was no significant difference in platelet suppression or medication adherence between groups. There were also differences between the groups in terms of depression and anxiety, initially, as measured by HADS. No documented adverse event associated with the intervention was found.
CONCLUSIONS


Elderly patients are willing to use tablet devices to be educated about health conditions. Additional studies are required to measure the effectiveness and determine the most suitable timing and location for patient education.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04439864; https://clinicaltrials.gov/ct2/show/NCT04439864.",2020,"However, there was no significant difference in platelet suppression or medication adherence between groups.","['The mean age of participants was 60.4 years (SD 7.1); the majority of patients were black and non-Hispanic', 'University of Illinois Hospital and John H Stroger Jr Cook County Hospital with appropriate ethical approvals', 'Potential participants who received a post percutaneous coronary intervention (PCI) procedure with a drug-eluting stent were approached', 'Elderly patients', 'All patients older than 50 years and who spoke English were recruited']","['usual care or MyIDEA supplementation', 'My Interventional Drug-Eluting Stent Educational App (MyIDEA', 'P2Y12 inhibitors and aspirin']","['Medication adherence', 'Platelet suppression', 'feasibility analysis of recruitment and retention', 'Morisky medication adherence score and cardiology outcomes', 'platelet suppression or medication adherence', 'Burden-Benefit questionnaire, 36-Item Short Form Health Survey, and PCI knowledge questionnaire', 'Hospital Anxiety and Depression Scale (HADS', 'depression and anxiety']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0020005', 'cui_str': 'County Hospitals'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0376245', 'cui_str': 'English language'}]","[{'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.112566,"However, there was no significant difference in platelet suppression or medication adherence between groups.","[{'ForeName': 'Andrew Dallas', 'Initials': 'AD', 'LastName': 'Boyd', 'Affiliation': 'Department of Biomedical and Health Information Science, University of Illinois at Chicago, Chicago, United States.'}, {'ForeName': 'Chioma Iheanyi', 'Initials': 'CI', 'LastName': 'Ndukwe', 'Affiliation': 'Department of Biomedical and Health Information Science, University of Illinois at Chicago, Chicago, United States.'}, {'ForeName': 'Anandu', 'Initials': 'A', 'LastName': 'Dileep', 'Affiliation': 'Department of Biomedical and Health Information Science, University of Illinois at Chicago, Chicago, United States.'}, {'ForeName': 'Olivia Frances', 'Initials': 'OF', 'LastName': 'Everin', 'Affiliation': 'Department of Biomedical and Health Information Science, University of Illinois at Chicago, Chicago, United States.'}, {'ForeName': 'Yingwei', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Biobehavioral Nursing Science, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Welland', 'Affiliation': 'Patient Advisor, Department of Biomedical and Health Information Sciences, University of Illinois at Chicago, Chicago, IL, United States.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Field', 'Affiliation': 'Patient Advisor, Department of Biomedical and Health Information Sciences, University of Illinois at Chicago, Chicago, IL, United States.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Baumann', 'Affiliation': 'Patient Advisor, Department of Biomedical and Health Information Sciences, University of Illinois at Chicago, Chicago, IL, United States.'}, {'ForeName': 'Jose D', 'Initials': 'JD', 'LastName': 'Flores', 'Affiliation': 'Patient Advisor, Department of Biomedical and Health Information Sciences, University of Illinois at Chicago, Chicago, IL, United States.'}, {'ForeName': 'Adhir', 'Initials': 'A', 'LastName': 'Shroff', 'Affiliation': 'Department of Biomedical and Health Information Science, University of Illinois at Chicago, Chicago, United States.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Groo', 'Affiliation': 'Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, IL, United States.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Dickens', 'Affiliation': 'Department of Biomedical and Health Information Science, University of Illinois at Chicago, Chicago, United States.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Doukky', 'Affiliation': 'Divison of Cardiology, Cook County Health, Chicago, IL, United States.'}, {'ForeName': 'Regeena', 'Initials': 'R', 'LastName': 'Francis', 'Affiliation': 'Divison of Cardiology, Cook County Health, Chicago, IL, United States.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Peacock', 'Affiliation': 'Divison of Cardiology, Cook County Health, Chicago, IL, United States.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Wilkie', 'Affiliation': 'Biobehavioral Nursing Science, University of Florida, Gainesville, FL, United States.'}]",JMIR mHealth and uHealth,['10.2196/15900']
917,32442154,Feasibility and Utility of mHealth for the Remote Monitoring of Parkinson Disease: Ancillary Study of the PD_manager Randomized Controlled Trial.,"BACKGROUND


Mobile health, predominantly wearable technology and mobile apps, have been considered in Parkinson disease to provide valuable ecological data between face-to-face visits and improve monitoring of motor symptoms remotely.
OBJECTIVE


We explored the feasibility of using a technology-based mHealth platform comprising a smartphone in combination with a smartwatch and a pair of smart insoles, described in this study as the PD_manager system, to collect clinically meaningful data. We also explored outcomes and disease-related factors that are important determinants to establish feasibility. Finally, we further validated a tremor evaluation method with data collected while patients performed their daily activities.
METHODS


PD_manager trial was an open-label parallel group randomized study.The mHealth platform consists of a wristband, a pair of sensor insoles, a smartphone (with dedicated mobile Android apps) and a knowledge platform serving as the cloud backend. Compliance was assessed with statistical analysis and the factors affecting it using appropriate regression analysis. The correlation of the scores of our previous algorithm for tremor evaluation and the respective Unified Parkinson's Disease Rating Scale estimations by clinicians were explored.
RESULTS


Of the 75 study participants, 65 (87%) completed the protocol. They used the PD_manager system for a median 11.57 (SD 3.15) days. Regression analysis suggests that the main factor associated with high use was caregivers' burden. Motor Aspects of Experiences of Daily Living and patients' self-rated health status also influence the system's use. Our algorithm provided clinically meaningful data for the detection and evaluation of tremor.
CONCLUSIONS


We found that PD patients, regardless of their demographics and disease characteristics, used the system for 11 to 14 days. The study further supports that mHealth can be an effective tool for the ecologically valid, passive, unobtrusive monitoring and evaluation of symptoms. Future studies will be required to demonstrate that an mHealth platform can improve disease management and care.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN17396879; http://www.isrctn.com/ISRCTN17396879.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s13063-018-2767-4.",2020,"The correlation of the scores of our previous algorithm for tremor evaluation and the respective Unified Parkinson's Disease Rating Scale estimations by clinicians were explored.
","['Of the 75 study participants, 65 (87%) completed the protocol', 'Parkinson Disease']",['technology-based mHealth platform'],[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]",[],75.0,0.0514528,"The correlation of the scores of our previous algorithm for tremor evaluation and the respective Unified Parkinson's Disease Rating Scale estimations by clinicians were explored.
","[{'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Gatsios', 'Affiliation': 'Department of Neurology, Medical School, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Antonini', 'Affiliation': 'Department of Neuroscience, University of Padua, Padua, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Gentile', 'Affiliation': 'Department of Neuroscience, University of Padua, Padua, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Marcante', 'Affiliation': 'San Camillo Hospital Istituto Di Ricovero e Cura a Carattere Scientifico, Venice, Italy.'}, {'ForeName': 'Clelia', 'Initials': 'C', 'LastName': 'Pellicano', 'Affiliation': 'Laboratory of Neuropsychiatry, Fondazione Santa Lucia Istituto Di Ricovero e Cura a Carattere Scientifico, Rome, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Macchiusi', 'Affiliation': 'Laboratory of Neuropsychiatry, Fondazione Santa Lucia Istituto Di Ricovero e Cura a Carattere Scientifico, Rome, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Assogna', 'Affiliation': 'Laboratory of Neuropsychiatry, Fondazione Santa Lucia Istituto Di Ricovero e Cura a Carattere Scientifico, Rome, Italy.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Spalletta', 'Affiliation': 'Laboratory of Neuropsychiatry, Fondazione Santa Lucia Istituto Di Ricovero e Cura a Carattere Scientifico, Rome, Italy.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gage', 'Affiliation': 'Surrey Health Economics Centre, Department of Clinical and Experimental Medicine, University of Surrey, Guildford, United Kingdom.'}, {'ForeName': 'Morro', 'Initials': 'M', 'LastName': 'Touray', 'Affiliation': 'Surrey Health Economics Centre, Department of Clinical and Experimental Medicine, University of Surrey, Guildford, United Kingdom.'}, {'ForeName': 'Lada', 'Initials': 'L', 'LastName': 'Timotijevic', 'Affiliation': 'School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, United Kingdom.'}, {'ForeName': 'Charo', 'Initials': 'C', 'LastName': 'Hodgkins', 'Affiliation': 'School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, United Kingdom.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Chondrogiorgi', 'Affiliation': 'Department of Neurology, Medical School, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Rigas', 'Affiliation': 'Unit of Medical Technology and Intelligent Information System, Department of Materials Science and Engineering, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Dimitrios I', 'Initials': 'DI', 'LastName': 'Fotiadis', 'Affiliation': 'Unit of Medical Technology and Intelligent Information System, Department of Materials Science and Engineering, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Spyridon', 'Initials': 'S', 'LastName': 'Konitsiotis', 'Affiliation': 'Department of Neurology, Medical School, University of Ioannina, Ioannina, Greece.'}]",JMIR mHealth and uHealth,['10.2196/16414']
918,32449542,Should We Consider Deep Brain Stimulation Discontinuation in Late-Stage Parkinson's Disease?,"BACKGROUND


Subthalamic deep brain stimulation (STN-DBS) effects may decrease with Parkinson's disease (PD) progression. There is no indication if, when, and how to consider the interruption of DBS treatment in late-stage PD. The objective of the current study was to investigate the percentage of ""poor stimulation responders"" among late-stage PD patients for elaborating an algorithm to decide whether and when DBS discontinuation may be considered.
METHODS


Late-stage PD patients (Hoehn Yahr stage ≥4 and Schwab and England Scale <50 in medication on/stimulation on condition) treated with STN-DBS for at least 5 years underwent a crossover, double-blind, randomized evaluation of acute effects of stimulation. Physicians, caregivers, and patients were blinded to stimulation conditions. Poor stimulation responders (MDS-UPDRS part III change <10% between stimulation on/medication off and stimulation off/medication off) maintained the stimulation off/medication on condition for 1 month for open-label assessment.
RESULTS


Thirty-six patients were included. The acute effect of stimulation was significant (17% MDS-UPDRS part III), with 80% of patients classified as ""good responders."" Seven patients were classified as ""poor stimulation responders,"" and the stimulation was switched off, but in 4 cases the stimulation was switched back ""on"" because of worsening of parkinsonism and dysphagia with a variable time delay (up to 10 days). No serious adverse effects occurred.
CONCLUSIONS


The vast majority of late-stage PD patients (92%) show a meaningful response to STN-DBS. Effects of stimulation may take days to disappear after its discontinuation. We present a safe and effective decisional algorithm that could guide physicians and caregivers in making challenging therapeutic decisions in late-stage PD. © 2020 International Parkinson and Movement Disorder Society.",2020,"No serious adverse effects occurred.
","['Thirty-six patients were included', 'Late-stage PD patients (Hoehn Yahr stage ≥4 and Schwab and England Scale <50 in medication on/stimulation on condition) treated with STN-DBS for at least 5\u2009years']","['Deep Brain Stimulation Discontinuation', 'Subthalamic deep brain stimulation (STN-DBS']",[],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0038427', 'cui_str': 'Bruneomycin'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0038427', 'cui_str': 'Bruneomycin'}]",[],36.0,0.041704,"No serious adverse effects occurred.
","[{'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Fabbri', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Zibetti', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}, {'ForeName': 'Mario Giorgio', 'Initials': 'MG', 'LastName': 'Rizzone', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Giannini', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Borellini', 'Affiliation': ""U.O. Neurofisiopatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Stefani', 'Affiliation': 'Department of System Medicine, UOSD Parkinson, University of Rome ""Tor Vergata,"", Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bove', 'Affiliation': 'U.O.C. Neurologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bruno', 'Affiliation': 'IRCCS Neuromed, Pozzilli, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Calandra-Buonaura', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Modugno', 'Affiliation': 'IRCCS Neuromed, Pozzilli, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Piano', 'Affiliation': 'U.O.C. Neurologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Peppe', 'Affiliation': 'IRCCS Santa Lucia Foundation, Rome, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Ardolino', 'Affiliation': ""U.O. Neurofisiopatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Romagnolo', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}, {'ForeName': 'Carlo Alberto', 'Initials': 'CA', 'LastName': 'Artusi', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Berchialla', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Montanaro', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Cortelli', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.'}, {'ForeName': 'Romito', 'Initials': 'R', 'LastName': 'Luigi', 'Affiliation': 'Department of Clinical Neurosciences, Movement Disorders Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Eleopra', 'Affiliation': 'Department of Clinical Neurosciences, Movement Disorders Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Brigida', 'Initials': 'B', 'LastName': 'Minafra', 'Affiliation': 'Parkinson and Movement Disorder Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Pacchetti', 'Affiliation': 'Parkinson and Movement Disorder Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Tufo', 'Affiliation': 'U.O.C. Neurochirurgia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Cogiamanian', 'Affiliation': ""U.O. Neurofisiopatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.""}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Lopiano', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28091']
919,32448935,Is it time to abandon episiotomy use? A randomized controlled trial (EPITRIAL).,"INTRODUCTION AND HYPOTHESIS


The objective of this trial was to evaluate whether avoidance of episiotomy can decrease the risk of advanced perineal tears.
METHODS


In this randomized (1:1) parallel-group superiority trial, primiparous women underwent randomization into ""avoidance of episiotomy"" (the study group in which episiotomy was allowed only in cases of fetal distress) or ""standard care."" The primary outcome was the incidence of advanced (3rd- and 4th-degree) perineal tears.
RESULTS


The participants were randomized into ""standard care"" (n = 337) vs. ""no episiotomy"" (n = 339) groups, not differing in any demographic or obstetric characteristics. Episiotomy rates were significantly lower in the study group (19.6%) compared with the standard care group (29.8%, p = 0.004). Five (1.5%) advanced tears were diagnosed in the study group vs. ten = 3.0% in the controls, yielding an odds ratio of 0.50 (95% CI 0.17-1.50) in favor of the ""no episiotomy"" group (p = 0.296). No differences were noted in any secondary outcomes. By per protocol analysis (omitting cases in which episiotomy was performed for indications other than fetal distress in the study group), a trend to decreased risk of advanced tears in the study group was noted (p = 0.0956). By per protocol analyses, no severe tears were noted in the 53 vacuum deliveries in the study group vs. 4/65 (6.2%) tears in the controls (p = 0.126).
CONCLUSIONS


Since decreased use of episiotomy was not associated with higher rates of severe tears or any other adverse outcomes, we believe this procedure can be avoided in spontaneous as well as vacuum-assisted deliveries. Trial registration no. NCT02356237.",2020,"Episiotomy rates were significantly lower in the study group (19.6%) compared with the standard care group (29.8%, p = 0.004).",['primiparous women underwent'],"['standard care"" (n\u2009=\u2009337) vs. ""no episiotomy', 'randomization into ""avoidance of episiotomy']","['Episiotomy rates', 'severe tears', 'incidence of advanced (3rd- and 4th-degree) perineal tears', 'risk of advanced tears']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0240713', 'cui_str': 'Laceration of perineum'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.150924,"Episiotomy rates were significantly lower in the study group (19.6%) compared with the standard care group (29.8%, p = 0.004).","[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Sagi-Dain', 'Affiliation': 'Department of Obstetrics and Gynecology, Carmel Medical Center, 7 Michal St., Haifa, Israel. lena2303@gmail.com.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Kreinin-Bleicher', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Bahous', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Noga', 'Initials': 'N', 'LastName': 'Gur Arye', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Shema', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Eshel', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Orna', 'Initials': 'O', 'LastName': 'Caspin', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Gonen', 'Affiliation': 'The Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Shlomi', 'Initials': 'S', 'LastName': 'Sagi', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.'}]",International urogynecology journal,['10.1007/s00192-020-04332-2']
920,32451528,Emotional Awareness and Expression Therapy Achieves Greater Pain Reduction than Cognitive Behavioral Therapy in Older Adults with Chronic Musculoskeletal Pain: A Preliminary Randomized Comparison Trial.,"OBJECTIVE


Emotional awareness and expression therapy (EAET) emphasizes the importance of the central nervous system and emotional processing in the etiology and treatment of chronic pain. Prior trials suggest EAET can substantially reduce pain; however, only one has compared EAET with an established alternative, demonstrating some small advantages over cognitive behavioral therapy (CBT) for fibromyalgia. The current trial compared EAET with CBT in older, predominately male, ethnically diverse veterans with chronic musculoskeletal pain.
DESIGN


Randomized comparison trial.
SETTING


Outpatient clinics at the West Los Angeles VA Medical Center.
SUBJECTS


Fifty-three veterans (mean age = 73.5 years, 92.4% male) with chronic musculoskeletal pain.
METHODS


Patients were randomized to EAET or CBT, each delivered as one 90-minute individual session and eight 90-minute group sessions. Pain severity (primary outcome), pain interference, anxiety, and other secondary outcomes were assessed at baseline, post-treatment, and three-month follow-up.
RESULTS


EAET produced significantly lower pain severity than CBT at post-treatment and follow-up; differences were large (partial η2 = 0.129 and 0.157, respectively). At post-treatment, 41.7% of EAET patients had >30% pain reduction, one-third had >50%, and 12.5% had >70%. Only one CBT patient achieved at least 30% pain reduction. Secondary outcomes demonstrated small to medium effect size advantages of EAET over CBT, although only post-treatment anxiety reached statistical significance.
CONCLUSIONS


This trial, although preliminary, supports prior research suggesting that EAET may be a treatment of choice for many patients with chronic musculoskeletal pain. Psychotherapy may achieve substantial pain reduction if pain neuroscience principles are emphasized and avoided emotions are processed.",2020,"RESULTS


EAET produced significantly lower pain severity than CBT at post-treatment and follow-up; differences were large (partial η2 = 0.129 and 0.157, respectively).","['Fifty-three veterans (mean age\u2009=\u200973.5\u2009years, 92.4% male) with chronic musculoskeletal pain', 'patients with chronic musculoskeletal pain', 'Patients', 'older, predominately male, ethnically diverse veterans with chronic musculoskeletal pain', 'chronic pain', 'Older Adults with Chronic Musculoskeletal Pain', 'Outpatient clinics at the West Los Angeles VA Medical Center']","['Emotional awareness and expression therapy (EAET', 'EAET with CBT', 'Cognitive Behavioral Therapy', 'Psychotherapy', 'cognitive behavioral therapy (CBT']","['pain reduction', 'Pain Reduction', 'Pain severity (primary outcome), pain interference, anxiety, and other secondary outcomes', 'small to medium effect size advantages of EAET over CBT, although only post-treatment anxiety reached statistical significance', 'pain', 'pain severity', 'Emotional Awareness and Expression Therapy']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",,0.074013,"RESULTS


EAET produced significantly lower pain severity than CBT at post-treatment and follow-up; differences were large (partial η2 = 0.129 and 0.157, respectively).","[{'ForeName': 'Brandon C', 'Initials': 'BC', 'LastName': 'Yarns', 'Affiliation': 'Department of Mental Health, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Lumley', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Justina T', 'Initials': 'JT', 'LastName': 'Cassidy', 'Affiliation': 'Department of Mental Health, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'W Neil', 'Initials': 'WN', 'LastName': 'Steers', 'Affiliation': 'VA HSR&D Center for the Study of Healthcare Innovation, Implementation & Policy (CSHIIP), VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Osato', 'Affiliation': 'Department of Mental Health, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Schubiner', 'Affiliation': 'Department of Internal Medicine, Ascension Providence Hospital, Southfield, Michigan.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Sultzer', 'Affiliation': 'Department of Psychiatry and Human Behavior, University of California, Irvine School of Medicine, Irvine, California, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa145']
921,32456272,Optimizing the Interaction of Exercise Volume and Metformin to Induce a Clinically Significant Reduction in Metabolic Syndrome Severity: A Randomised Trial.,"Insulin resistance is a central mediating factor of the metabolic syndrome (MetS), with exercise training and metformin proven antidotes to insulin resistance. However, when the two therapies are combined there is conflicting data regarding whether metformin blunts or improves exercise training-induced adaptations. The volume of exercise (duration, intensity, and frequency) on the interaction of exercise training and metformin has yet to be investigated. The aim of this study is therefore to explore the impact of a combination of different exercise volumes and metformin on MetS severity. This is a secondary analysis of data from one of the sites of the 'Exercise in Prevention of Metabolic Syndrome' (EX-MET) study. Ninety-nine adults with MetS were randomized into a 16-week exercise program completing either: (i) moderate-intensity continuous training (MICT) at 60-70% of peak heart rate (HRpeak) for 30 min/session ( n  = 34, 150 min/week); (ii) high-volume high-intensity interval training (HIIT) consisting of 4 × 4 min bouts at 85-95% HRpeak, interspersed with 3 min of active recovery at 50-70% HRpeak ( n  = 34, 38 min/session, 114 min/week); or (iii) low volume HIIT, 1 × 4 min bout of HIIT at 85-95% HRpeak ( n  = 31, 17 min/session, 51 min/week). Metformin intake was monitored and recorded throughout the trial. MetS severity was calculated as z-scores derived from MetS risk factors assessed at pre- and post-intervention. Sixty-five participants had complete pre- and post-intervention data for MetS z-score, of which 18 participants (28%) were taking metformin. Over the 16-week intervention, a similar proportion of participants clinically improved MetS severity (Δ ≥ -0.87) with metformin (8/18, 44%) or without metformin (23/47, 49%) ( p  = 0.75). While there were no between-group differences ( p  = 0.24), in those who did not take metformin low-volume HIIT had more likely responders (10/15, 67%) compared to MICT (6/16, 38%) and high-volume HIIT (7/16, 44%). In those taking metformin, there was a lower proportion of participants who clinically improved MetS severity following high-volume HIIT (1/6, 17%) compared to MICT (2/4, 50%) and low-volume HIIT (5/8, 63%), but with no between-group difference ( p  = 0.23). Moreover, in those who performed high-volume HIIT, there was a statistically significantly higher proportion ( p  = 0.03) of likely non-responders with improved MetS severity in participants taking metformin (4/6, 67%) compared to those not taking metformin (3/16, 19%). In individuals with MetS, the effect of high volume HIIT on MetS severity may be blunted in those taking metformin. These findings need to be confirmed in a larger study.",2020,"Over the 16-week intervention, a similar proportion of participants clinically improved MetS severity (Δ ≥ -0.87) with metformin (8/18, 44%) or without metformin (23/47, 49%) ( p  = 0.75).","['Ninety-nine adults with MetS', 'Sixty-five participants had complete pre- and post-intervention data for MetS z-score, of which 18 participants (28%) were taking']","['exercise training and metformin', 'Metformin', 'metformin', 'exercise program completing either: (i) moderate-intensity continuous training (MICT', 'MICT', 'high-volume high-intensity interval training (HIIT) consisting of 4 × 4 min bouts at 85-95% HRpeak, interspersed with 3 min of active recovery at 50-70% HRpeak']","['MetS severity', 'volume of exercise (duration, intensity, and frequency']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",99.0,0.0481252,"Over the 16-week intervention, a similar proportion of participants clinically improved MetS severity (Δ ≥ -0.87) with metformin (8/18, 44%) or without metformin (23/47, 49%) ( p  = 0.75).","[{'ForeName': 'Joyce S', 'Initials': 'JS', 'LastName': 'Ramos', 'Affiliation': 'Caring Futures Institute & SHAPE Research Centre, Exercise Science and Clinical Exercise Physiology, College of Nursing and Health Sciences, Flinders University, Room S268, South Wing, Sturt Building, Bedford Park, Adelaide 5042, South Australia, Australia.'}, {'ForeName': 'Lance C', 'Initials': 'LC', 'LastName': 'Dalleck', 'Affiliation': 'Caring Futures Institute & SHAPE Research Centre, Exercise Science and Clinical Exercise Physiology, College of Nursing and Health Sciences, Flinders University, Room S268, South Wing, Sturt Building, Bedford Park, Adelaide 5042, South Australia, Australia.'}, {'ForeName': 'Caitlin E', 'Initials': 'CE', 'LastName': 'Keith', 'Affiliation': 'Caring Futures Institute & SHAPE Research Centre, Exercise Science and Clinical Exercise Physiology, College of Nursing and Health Sciences, Flinders University, Room S268, South Wing, Sturt Building, Bedford Park, Adelaide 5042, South Australia, Australia.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Fennell', 'Affiliation': 'Caring Futures Institute & SHAPE Research Centre, Exercise Science and Clinical Exercise Physiology, College of Nursing and Health Sciences, Flinders University, Room S268, South Wing, Sturt Building, Bedford Park, Adelaide 5042, South Australia, Australia.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Lee', 'Affiliation': 'Caring Futures Institute & SHAPE Research Centre, Exercise Science and Clinical Exercise Physiology, College of Nursing and Health Sciences, Flinders University, Room S268, South Wing, Sturt Building, Bedford Park, Adelaide 5042, South Australia, Australia.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Drummond', 'Affiliation': 'Caring Futures Institute & SHAPE Research Centre, Exercise Science and Clinical Exercise Physiology, College of Nursing and Health Sciences, Flinders University, Room S268, South Wing, Sturt Building, Bedford Park, Adelaide 5042, South Australia, Australia.'}, {'ForeName': 'Shelley E', 'Initials': 'SE', 'LastName': 'Keating', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Fassett', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane 4072, Queensland, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17103695']
922,32462509,Effect of a geriatric intervention aiming to improve polypharmacy in nursing homes.,"PURPOSE


To examine the effect of an intervention comprising professional support by a geriatrician engaged in a quality care indicators' audit for nursing home (NH) staff on reducing polypharmacy.
METHODS


Of a total of 3709 NH residents, 90 NHs (2026 residents) were allocated to a light intervention and 85 NHs (1683 residents) to a strong intervention group.
RESULTS


Mixed-effect linear model found no significant variation in the total number of medications over time (β-coefficient for interaction 0.007, 95% CI - 0.15, 0.16). Within-group-adjusted mean differences showed a statistical decline in the psychotropic medication class (- 0.04 SE 0.02 p 0.03 for the strong intervention group and - 0.06 SE 0.02 p 0.001 for the light intervention group) and a statistically significant increase in the analgesics use.
CONCLUSION


The possibility that a simple audit intervention might reduce psychotropic prescriptions deserves further investigation.",2020,Within-group-adjusted mean differences showed a statistical decline in the psychotropic medication class (- 0.04 SE 0.02,"['nursing homes', 'Of a total of 3709 NH residents', '90 NHs (2026 residents']","['light intervention and 85 NHs (1683 residents) to a strong intervention group', 'geriatric intervention']","['analgesics use', 'total number of medications over time (β-coefficient']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",3709.0,0.0270268,Within-group-adjusted mean differences showed a statistical decline in the psychotropic medication class (- 0.04 SE 0.02,"[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'El Haddad', 'Affiliation': 'Gérontopôle, Department of Internal Medicine and Geriatrics, Toulouse University Hospital, 31059, Toulouse, France. kamal.elhaddad@hotmail.com.'}, {'ForeName': 'Philipe', 'Initials': 'P', 'LastName': 'de Souto Barreto', 'Affiliation': 'Gérontopôle, Department of Internal Medicine and Geriatrics, Toulouse University Hospital, 31059, Toulouse, France.'}, {'ForeName': 'Clarisse Laffon', 'Initials': 'CL', 'LastName': 'de Mazieres', 'Affiliation': 'Gérontopôle, Department of Internal Medicine and Geriatrics, Toulouse University Hospital, 31059, Toulouse, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Gérontopôle, Department of Internal Medicine and Geriatrics, Toulouse University Hospital, 31059, Toulouse, France.'}]",European geriatric medicine,['10.1007/s41999-019-00279-w']
923,32463470,Bupropion for the Treatment of Apathy in Alzheimer Disease: A Randomized Clinical Trial.,"Importance


Apathy is a frequent neuropsychiatric symptom in dementia of Alzheimer type and negatively affects the disease course and patients' and caregivers' quality of life. Effective treatment options are needed.
Objective


To examine the efficacy and safety of the dopamine and noradrenaline reuptake inhibitor bupropion in the treatment of apathy in patients with dementia of Alzheimer type.
Design, Setting, and Participants


This 12-week, multicenter, double-blind, placebo-controlled, randomized clinical trial was conducted in a psychiatric and neurological outpatient setting between July 2010 and July 2014 in Germany. Patients with mild-to-moderate dementia of Alzheimer type and clinically relevant apathy were included. Patients with additional clinically relevant depressed mood were excluded. Data analyses were performed between August 2018 and August 2019.
Interventions


Patients received either bupropion or placebo (150 mg for 4 weeks plus 300 mg for 8 weeks). In case of intolerability of 300 mg, patients continued to receive 150 mg throughout the study.
Main Outcomes and Measures


Change on the Apathy Evaluation Scale-Clinician Version (AES-C) (score range, 18-72 points) between baseline and week 12 was the primary outcome parameter. Secondary outcome parameters included measures of neuropsychiatric symptoms, cognition, activities of daily living, and quality of life. Outcome measures were assessed at baseline and at 4, 8, and 12 weeks.
Results


A total of 108 patients (mean [SD] age, 74.8 [5.9] years; 67 men [62%]) were included in the intention-to-treat analysis, with 54 randomized to receive bupropion and 54 randomized to receive placebo. The baseline AES-C score was comparable between the bupropion group and the placebo group (mean [SD], 52.2 [8.7] vs 50.4 [8.2]). After controlling for the baseline AES-C score, site, and comedication with donepezil or galantamine, the mean change in the AES-C score between the bupropion and placebo groups was not statistically significant (mean change, 2.22; 95% CI, -0.47 to 4.91; P = .11). Results on secondary outcomes showed statistically significant differences between bupropion and placebo in terms of total neuropsychiatric symptoms (mean change, 5.52; 95% CI, 2.00 to 9.04; P = .003) and health-related quality of life (uncorrected for multiple comparisons; mean change, -1.66; 95% CI, -3.01 to -0.31; P = .02) with greater improvement in the placebo group. No statistically significant changes between groups were found for activities of daily living (mean change, -2.92; 95% CI, -5.89 to 0.06; P = .05) and cognition (mean change, -0.27; 95% CI, -3.26 to 2.73; P = .86). The numbers of adverse events (bupropion group, 39 patients [72.2%]; placebo group, 33 patients [61.1%]) and serious adverse events (bupropion group, 5 patients [9.3%]; placebo group, 2 patients [3.7%]) were comparable between groups.
Conclusions and Relevance


Although it is safe, bupropion was not superior to placebo for the treatment of apathy in patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood.
Trial Registration


EU Clinical Trials Register Identifier: 2007-005352-17.",2020,"Although it is safe, bupropion was not superior to placebo for the treatment of apathy in patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood.
","['Apathy in Alzheimer Disease', '108 patients (mean [SD] age, 74.8 [5.9] years', 'Patients with additional clinically relevant depressed mood were excluded', 'psychiatric and neurological outpatient setting between July 2010 and July 2014 in Germany', ' 67 men [62%]) were included in the intention-to-treat analysis, with 54 randomized to receive', 'patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood', 'Patients with mild-to-moderate dementia of Alzheimer type and clinically relevant apathy were included', 'patients with dementia of Alzheimer type']","['Bupropion', 'dopamine and noradrenaline reuptake inhibitor bupropion', 'donepezil or galantamine', 'bupropion or placebo', 'bupropion', 'placebo']","['AES-C score', 'numbers of adverse events', 'health-related quality of life', 'total neuropsychiatric symptoms', 'neuropsychiatric symptoms, cognition, activities of daily living, and quality of life', 'Apathy Evaluation Scale-Clinician Version (AES-C', 'efficacy and safety', 'serious adverse events', 'baseline AES-C score', 'cognition', 'activities of daily living']","[{'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C3665464', 'cui_str': ""Dementia in Alzheimer's disease, unspecified""}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C1319313', 'cui_str': 'Norepinephrine reuptake inhibitor-containing product'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0016967', 'cui_str': 'Galantamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",108.0,0.521266,"Although it is safe, bupropion was not superior to placebo for the treatment of apathy in patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood.
","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Maier', 'Affiliation': 'Department of Psychiatry, University Hospital Cologne, Medical Faculty, Cologne, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Spottke', 'Affiliation': 'German Center for Neurodegenerative Diseases, Bonn, Germany.'}, {'ForeName': 'Jan-Philipp', 'Initials': 'JP', 'LastName': 'Bach', 'Affiliation': 'Department of Geriatric Medicine, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bartels', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Goettingen, Georg-August-University, Goettingen, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Buerger', 'Affiliation': 'Institute for Stroke and Dementia Research, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Dodel', 'Affiliation': 'Department of Geriatric Medicine, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fellgiebel', 'Affiliation': 'Center for Mental Health in Old Age, Landeskrankenhaus, Mainz, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Fliessbach', 'Affiliation': 'German Center for Neurodegenerative Diseases, Bonn, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Frölich', 'Affiliation': 'Department of Geriatric Psychiatry, Zentralinstitut für Seelische Gesundheit Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Lucrezia', 'Initials': 'L', 'LastName': 'Hausner', 'Affiliation': 'Department of Geriatric Psychiatry, Zentralinstitut für Seelische Gesundheit Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klöppel', 'Affiliation': 'University Hospital of Old Age Psychiatry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Klostermann', 'Affiliation': 'German Center for Neurodegenerative Diseases, Berlin, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kornhuber', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Friedrich Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Laske', 'Affiliation': 'German Center for Neurodegenerative Diseases, Tübingen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Peters', 'Affiliation': 'German Center for Neurodegenerative Diseases, Berlin, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Priller', 'Affiliation': 'German Center for Neurodegenerative Diseases, Berlin, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Richter-Schmidinger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Friedrich Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Schneider', 'Affiliation': 'German Center for Neurodegenerative Diseases, Bonn, Germany.'}, {'ForeName': 'Kija', 'Initials': 'K', 'LastName': 'Shah-Hosseini', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Teipel', 'Affiliation': 'German Center for Neurodegenerative Diseases, Rostock, Germany.'}, {'ForeName': 'Christine A F', 'Initials': 'CAF', 'LastName': 'von Arnim', 'Affiliation': 'Department of Neurology, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Wiltfang', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Goettingen, Georg-August-University, Goettingen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Jessen', 'Affiliation': 'Department of Psychiatry, University Hospital Cologne, Medical Faculty, Cologne, Germany.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6027']
924,32459724,Increasing Fusion Rate Between 1 and 2 Years After Instrumented Posterolateral Spinal Fusion and the Role of Bone Grafting.,"STUDY DESIGN


Two-year clinical and radiographic follow-up of a double-blind, multicenter, randomized, intra-patient controlled, non-inferiority trial comparing a bone graft substitute (AttraX Putty) with autograft in instrumented posterolateral fusion (PLF) surgery.
OBJECTIVES


The aim of this study was to compare PLF rates between 1 and 2 years of follow-up and between graft types, and to explore the role of bone grafting based on the location of the PLF mass.
SUMMARY OF BACKGROUND DATA


There are indications that bony fusion proceeds over time, but it is unknown to what extent this can be related to bone grafting.
METHODS


A total of 100 adult patients underwent a primary, single- or multilevel, thoracolumbar PLF. After instrumentation and preparation for grafting, the randomized allocation side of AttraX Putty was disclosed. The contralateral posterolateral gutters were grafted with autograft. At 1-year follow-up, and in case of no fusion at 2 years, the fusion status of both sides of each segment was blindly assessed on CT scans. Intertransverse and facet fusion were scored separately. Difference in fusion rates after 1 and 2 years and between grafts were analyzed with a Generalized Estimating Equations (GEE) model (P < 0.05).
RESULTS


The 2-year PLF rate (66 patients) was 70% at the AttraX Putty and 68% at the autograft side, compared to 55% and 52% after 1 year (87 patients). GEE analysis demonstrated a significant increase for both conditions (odds ratio 2.0, 95% confidence interval 1.5-2.7, P < 0.001), but no difference between the grafts (P = 0.595). Ongoing bone formation was only observed between the facet joints.
CONCLUSION


This intra-patient controlled trial demonstrated a significant increase in PLF rate between 1 and 2 years after instrumented thoracolumbar fusion, but no difference between AttraX Putty and autograft. Based on the location of the PLF mass, this increase is most likely the result of immobilization instead of grafting.
LEVEL OF EVIDENCE


1.",2020,"GEE-analysis demonstrated a significant increase for both conditions (Odds ratio 2.0, 95% confidence interval 1.5 - 2.7, p < 0.001), but no difference between the grafts (p = 0.595).","['100 adult patients underwent a primary, single- or multilevel, thoracolumbar PLF']",['bone graft substitute (AttraX® Putty) with autograft in instrumented posterolateral fusion (PLF) surgery'],"['2-year PLF rate', 'Intertransverse and facet fusion', 'PLF rates', 'PLF rate', 'fusion rates', 'Increasing Fusion Rate', 'Ongoing bone formation']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]","[{'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]",100.0,0.0881156,"GEE-analysis demonstrated a significant increase for both conditions (Odds ratio 2.0, 95% confidence interval 1.5 - 2.7, p < 0.001), but no difference between the grafts (p = 0.595).","[{'ForeName': 'A Mechteld', 'Initials': 'AM', 'LastName': 'Lehr', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'F Cumhur', 'Initials': 'FC', 'LastName': 'Oner', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Diyar', 'Initials': 'D', 'LastName': 'Delawi', 'Affiliation': 'Department of Orthopaedic Surgery, St. Antonius Hospital, Utrecht, The Netherlands.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Stellato', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Hoebink', 'Affiliation': 'Department of Orthopaedic Surgery, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Diederik H R', 'Initials': 'DHR', 'LastName': 'Kempen', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Job L C', 'Initials': 'JLC', 'LastName': 'van Susante', 'Affiliation': 'Department of Orthopaedic Surgery, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'René M', 'Initials': 'RM', 'LastName': 'Castelein', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Moyo C', 'Initials': 'MC', 'LastName': 'Kruyt', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Spine,['10.1097/BRS.0000000000003558']
925,32461050,Hamstring strength and architectural adaptations following inertial flywheel resistance training.,"OBJECTIVES


To investigate the architectural and strength adaptations of the hamstrings following 6-weeks of inertial flywheel resistance training.
DESIGN


Randomised, stratified training intervention METHODS: Twenty healthy males undertook 6-weeks of a conventional (n=10) or eccentrically biased (n=10) flywheel leg-curl training intervention as well as a subsequent 4-week detraining period. Biceps femoris long head (BFlh) architecture was assessed weekly, whilst assessments of eccentric and isometric knee flexor strength and rate of force development (RFD) were conducted prior to and following the intervention and detraining periods.
RESULTS


The participants who undertook the eccentrically biased flywheel intervention showed a significant 14±5% (p<0.001, d=1.98) increase in BFlh fascicle length after 6-weeks of training. These improvements in fascicle length subsequently declined by 13±4% (p<0.001. d=-2.04) following the 4-week detraining period. The conventional flywheel leg-curl training group saw no changes in BFlh fascicle length after the intervention (-0.5%±0.8%, p=0.939, d=-0.04) or detraining (-1.1%±1%, p=0.984, d=-0.03) periods. Both groups saw no changes in any of the strength or RFD variables after the intervention or the detraining period.
CONCLUSIONS


Flywheel leg-curl training performed with an eccentric bias led to significant lengthening of BFlh fascicles without a change in RFD, eccentric or isometric strength. These increases in fascicle length were lost following a 4-week detraining period. Conventional flywheel leg-curl training resulted in no changes in fascicle length, strength and RFD. These findings suggest that additional eccentric bias is required during inertial flywheel resistance training to promote fascicle lengthening in the BFlh, however this may still be insufficient to cause alterations to strength and RFD.",2020,"The conventional flywheel leg-curl training group saw no changes in BFlh fascicle length after the intervention (-0.5%±0.8%, p=0.939, d=-0.04) or detraining (-1.1%±1%, p=0.984, d=-0.03) periods.",['Twenty healthy males undertook 6-weeks of a'],"['Conventional flywheel leg-curl training', 'conventional (n=10) or eccentrically biased (n=10) flywheel leg-curl training intervention', 'inertial flywheel resistance training']","['Biceps femoris long head (BFlh) architecture', 'Hamstring strength and architectural adaptations', 'fascicle length, strength and RFD', 'BFlh fascicle length', 'strength or RFD variables', 'RFD, eccentric or isometric strength', 'fascicle length', 'eccentric and isometric knee flexor strength and rate of force development (RFD']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0224449', 'cui_str': 'Biceps femoris muscle structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",20.0,0.0167128,"The conventional flywheel leg-curl training group saw no changes in BFlh fascicle length after the intervention (-0.5%±0.8%, p=0.939, d=-0.04) or detraining (-1.1%±1%, p=0.984, d=-0.03) periods.","[{'ForeName': 'Joel D', 'Initials': 'JD', 'LastName': 'Presland', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Opar', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia; Sports Performance, Recovery, Injury and New Technologies (SPRINT) Research Centre, Australian Catholic University, Fitzroy, Victoria, Australia.'}, {'ForeName': 'Morgan D', 'Initials': 'MD', 'LastName': 'Williams', 'Affiliation': 'School of Health, Sport and Professional Practice, University of South Wales, Pontypridd, Wales, UK.'}, {'ForeName': 'Jack T', 'Initials': 'JT', 'LastName': 'Hickey', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Nirav', 'Initials': 'N', 'LastName': 'Maniar', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Lee Dow', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Matthew N', 'Initials': 'MN', 'LastName': 'Bourne', 'Affiliation': 'School of Allied Health Sciences and Menzies Health Institute Queensland, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Ryan G', 'Initials': 'RG', 'LastName': 'Timmins', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia; Sports Performance, Recovery, Injury and New Technologies (SPRINT) Research Centre, Australian Catholic University, Fitzroy, Victoria, Australia. Electronic address: Ryan.Timmins@acu.edu.au.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.04.007']
926,32466710,Effects of acute alcohol consumption on emotion recognition in high and low trait aggressive drinkers.,"BACKGROUND


Research suggests that acute alcohol consumption impairs processing of emotional faces. As emotion processing plays a key role in effective social interaction, these impairments may be one mechanism by which alcohol changes social behaviour. This study investigated the effect of individual differences on this relationship by comparing emotion recognition performance after acute alcohol consumption in individuals with high and low trait aggression.
METHODS


Regular non-dependent drinkers, either high or low in trait aggression participated in a double-blind placebo-controlled experiment ( N  = 88, 50% high trait aggressive). Participants attended two sessions. In one they consumed an alcoholic drink (0.4 g/kg) and in the other they consumed a matched placebo. They then completed two computer-based tasks: one measured global and emotion-specific recognition performance across six primary emotions (anger, sadness, happiness, disgust, fear, surprise), the other measured processing bias of two ambiguously expressive faces (happy-angry/happy-sad).
RESULTS


There was evidence of poorer global emotion recognition after alcohol. In addition, there was evidence of poorer sensitivity to sadness and fear after alcohol. There was also evidence for a reduced bias towards happiness following alcohol and weak evidence for an increased bias towards sadness.
CONCLUSIONS


These findings suggest that alcohol impairs global emotion recognition. They also highlight a reduced ability to detect sadness and fearful facial expressions. As sadness and fear are cues of submission and distress (i.e. function to curtail aggression), failure to successfully detect these emotions when intoxicated may increase the likelihood of aggressive responding. This coupled with a reduced bias towards seeing happiness may collectively contribute to aggressive behaviour.",2020,There was evidence of poorer global emotion recognition after alcohol.,"['individuals with high and low trait aggression', 'Regular non-dependent drinkers, either high or low in trait aggression participated in a double-blind placebo-controlled experiment ( N  = 88, 50% high trait aggressive', 'high and low trait aggressive drinkers']","['acute alcohol consumption', 'alcoholic drink', 'placebo']","['poorer global emotion recognition', 'global and emotion-specific recognition performance across six primary emotions (anger, sadness, happiness, disgust, fear, surprise), the other measured processing bias of two ambiguously expressive faces (happy-angry/happy-sad', 'global emotion recognition', 'emotion recognition', 'emotion recognition performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}]",,0.189109,There was evidence of poorer global emotion recognition after alcohol.,"[{'ForeName': 'Andrew Pr', 'Initials': 'AP', 'LastName': 'Eastwood', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Penton-Voak', 'Affiliation': 'UK Centre for Tobacco and Alcohol Studies, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}, {'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'Attwood', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120922951']
927,32593960,Functional recovery in multiple sclerosis patients undergoing rehabilitation programs is associated with plasma levels of hemostasis inhibitors.,"BACKGROUND


Increasing evidence for contribution of hemostasis components in multiple sclerosis (MS) has been reported. Hemostasis protein inhibitors display key regulatory roles, extending to regulation of innate immune response and inflammation, and promotion of blood-brain barrier integrity. Whereas the effects on hemostasis of exercise and rehabilitation strategies have been extensively investigated, relationships between MS rehabilitation strategies and hemostasis have not been previously reported.
OBJECTIVES


To investigate in MS patients the association between outcomes of rehabilitative exercise and plasma levels of selected hemostasis inhibitors.
METHODS


Sixty-one severely disabled progressive-MS (P-MS) patients were randomized in the RAGTIME trial to receive 12 walking session of robot-assisted gait training (RAGT) or conventional overground therapy (CT). Outcome parameters were: timed 25-foot walk test (T25FWT) speed, 6-minute walking test (6MWT), Berg Balance Scale (BBS), and MS impact scale-29 (MSIS-29). Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI) were assayed by multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3). Descriptive analysis, trend analysis, Spearman's rank and Pearson's correlations, and multiple regression models were used.
RESULTS


Rehabilitative exercises moderately modified plasma protein concentrations. A significant trend to increase was observed for PS (p=0.015) and TFPI (p=0.047) in the whole population, and for PS (p=0.011) in the CT group. Correlation between TFPI and sTM levels was detectable at all time points in the whole P-MS patients and in RAGT group. The correlation between TFPI and PS, present at T0, was lost during the rehabilitation, and recovered at T3 in the whole population and CT group. During rehabilitation, positive variations of TFPI were inversely related with changes in 6MWT in the whole population (r=-0.309, p=0.021), and in the RAGT group (r=-0.51, p=0.004). In all P-MS, PS T0 levels were associated (r=0.379, p=0.004) with increased gait speed, which in the RAGT group was associated both with PS T0 (r=0.378, p=0.040), and sTM T0 (r=0.453, p=0.012). Accordingly, in the regression model including age, sex and EDSS and the stepwise enter of PS T0, higher PS T0 levels predicted increased gait speed in all P-MS (F=3.4, p=0.016) The regression model in the RAGT group indicated that higher PS and sTM T0 levels were both predictors of increased gait speed (F=5.7, p=0.001).
CONCLUSIONS


Plasma levels of coagulation inhibitors were related to variations of outcome measurements after high-intensity walking rehabilitation programs. Patients with decreased TFPI levels from T0 to T2 displayed the most significant functional recovery following rehabilitation, and particularly after RAGT. Higher baseline total PS levels were associated with favorable outcomes of rehabilitation therapies in MS. These novel findings, which suggest that plasma levels of hemostasis inhibitors might have implication for rehabilitative therapy options in MS, warrant further investigation.",2020,"Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI) were assayed by multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3).","['Sixty-one severely disabled progressive-MS (P-MS) patients', 'multiple sclerosis patients undergoing rehabilitation programs', 'multiple sclerosis (MS']",['12 walking session of robot-assisted gait training (RAGT) or conventional overground therapy (CT'],"['PS T0 levels', 'TFPI levels', 'Higher baseline total PS levels', 'gait speed', 'Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI', 'timed 25-foot walk test (T25FWT) speed, 6-minute walking test (6MWT), Berg Balance Scale (BBS), and MS impact scale-29 (MSIS-29', 'plasma protein concentrations', 'PS', 'TFPI', 'PS and sTM T0 levels', 'TFPI and sTM levels', 'multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0072393', 'cui_str': 'Protein S'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0164707', 'cui_str': 'Tissue factor pathway inhibitor'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1168441', 'cui_str': 'Protein S total'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",61.0,0.0295241,"Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI) were assayed by multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ziliotto', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara; School of Medicine and Surgery, University of Milano - Bicocca, Monza, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lamberti', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Manfredini', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy; Department of Neurosciences/Rehabilitation, Unit of Physical and Rehabilitation Medicine, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Straudi', 'Affiliation': 'Department of Neurosciences/Rehabilitation, Unit of Physical and Rehabilitation Medicine, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Baroni', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tisato', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Carantoni', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Secchiero', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Basaglia', 'Affiliation': 'Department of Neurosciences/Rehabilitation, Unit of Physical and Rehabilitation Medicine, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Marchetti', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bernardi', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara. Electronic address: ber@unife.it.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102319']
928,32594135,Co-administration of 5α-reductase Inhibitors Worsens the Adverse Metabolic Effects of Prescribed Glucocorticoids.,"CONTEXT


Glucocorticoids (GCs) are commonly prescribed, but their use is associated with adverse metabolic effects. 5α-reductase inhibitors (5α-RI) are also frequently prescribed, mainly to inhibit testosterone conversion to dihydrotestosterone. However, they also prevent the inactivation of GCs.
OBJECTIVE


We hypothesized that 5α-RI may worsen the adverse effects of GCs.
DESIGN


Prospective, randomized study.
PATIENTS


A total of 19 healthy male volunteers (age 45 ± 2 years; body mass index 27.1 ± 0.7kg/m2).
INTERVENTIONS


Participants underwent metabolic assessments; 2-step hyperinsulinemic, euglycemic clamp incorporating stable isotopes, adipose tissue microdialysis, and biopsy. Participants were then randomized to either prednisolone (10 mg daily) or prednisolone (10 mg daily) plus a 5α-RI (finasteride 5 mg daily or dutasteride 0.5 mg daily) for 7 days; metabolic assessments were then repeated.
MAIN OUTCOME MEASURES


Ra glucose, glucose utilization (M-value), glucose oxidation, and nonesterified fatty acids (NEFA) levels.
RESULTS


Co-administration of prednisolone with a 5α-RI increased circulating prednisolone levels (482 ± 96 vs 761 ± 57 nmol/L, P = 0.029). Prednisolone alone did not alter Ra glucose (2.55 ± 0.34 vs 2.62 ± 0.19 mg/kg/minute, P = 0.86), M-value (3.2 ± 0.5 vs 2.7 ± 0.7 mg/kg/minute, P = 0.37), or glucose oxidation (0.042 ± 0.007 vs 0.040 ± 0.004 mmol/hr/kg/minute, P = 0.79). However, co-administration with a 5α-RI increased Ra glucose (2.67 ± 0.16 vs 3.05 ± 0.18 mg/kg/minute, P < 0.05) and decreased M-value (4.0 ± 0.5 vs 2.6 ± 0.4 mg/kg/minute, P < 0.05), and oxidation (0.043 ± 0.003 vs 0.036 ± 0.002 mmol/hr/kg, P < 0.01). Similarly, prednisolone did not impair insulin-mediated suppression of circulating NEFA (43.1 ± 28.9 vs 36.8 ± 14.3 μmol/L, P = 0.81), unless co-administered with a 5α-RI (49.8 ± 8.6 vs 88.5 ± 13.5 μmol/L, P < 0.01).
CONCLUSIONS


We have demonstrated that 5α-RIs exacerbate the adverse effects of prednisolone. This study has significant translational implications, including the need to consider GC dose adjustments, but also the necessity for increased vigilance for the development of adverse effects.",2020,"Similarly, prednisolone did not impair insulin-mediated suppression of circulating NEFA (43.1±28.9 vs. 36.8±14.3μmol/L, p=0.81), unless co-administered with a 5aRI (49.8±8.6 vs. 88.5±13.5μmol/L, p<0.01).
","['19 healthy male volunteers (age; 45±2 years, BMI; 27.1±0.7kg/m2']","['5α-reductase inhibitors', '5aRI (finasteride 5mg daily or dutasteride', 'hyperinsulinemic, euglycemic clamp incorporating stable-isotopes, adipose tissue microdialysis and biopsy', 'Prednisolone', 'prednisolone']","['adverse metabolic effects', 'M-value', 'Ra glucose', 'Ra glucose, glucose utilization (M-value), glucose oxidation, non-esterified fatty acids (NEFA) levels', 'circulating prednisolone levels', 'glucose oxidation', 'insulin-mediated suppression of circulating NEFA']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0986066', 'cui_str': 'Finasteride 5 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0754659', 'cui_str': 'Dutasteride'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0302918', 'cui_str': 'Stable isotope'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0206056', 'cui_str': 'Microdialysis'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",19.0,0.0933746,"Similarly, prednisolone did not impair insulin-mediated suppression of circulating NEFA (43.1±28.9 vs. 36.8±14.3μmol/L, p=0.81), unless co-administered with a 5aRI (49.8±8.6 vs. 88.5±13.5μmol/L, p<0.01).
","[{'ForeName': 'Nantia', 'Initials': 'N', 'LastName': 'Othonos', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Marjot', 'Affiliation': 'Translational Gastroenterology Unit, NIHR Oxford Biomedical Research Centre, University of Oxford, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Woods', 'Affiliation': 'Department of Endocrinology, Naas General Hospital, Kildare and Tallaght Hospital, Dublin, Ireland.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Hazlehurst', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Edgbaston, Birmingham, UK.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Nikolaou', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Pofi', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, 00161, Italy.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'White', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Bonaventura', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, 00161, Italy.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Webster', 'Affiliation': 'Department of Pathology, University Hospitals Birmingham, NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Duffy', 'Affiliation': 'Department of Pathology, University Hospitals Birmingham, NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cornfield', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Moolla', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Isidori', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, 00161, Italy.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hodson', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Jeremy W', 'Initials': 'JW', 'LastName': 'Tomlinson', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa408']
929,32601985,The effects of suppressing the biological stress systems on social threat-assessment following acute stress.,"RATIONALE


Stress is associated with increased sensitivity to threat. Previous investigations examining how stress affects threat processing have largely focused on biomarker responses associated with either the sympathetic-nervous-system (SNS) or the hypothalamus-pituitary-adrenal (HPA) axis.
OBJECTIVES


We pharmacologically suppressed activations of SNS, HPA, or both, prior to stress and investigated how each stress system modulates social threat assessment.
METHODS


One hundred sixty-one healthy men and women were randomized in a between-subject design, to one of four pharmacological or placebo conditions: dexamethasone-placebo, placebo-propranolol, dexamethasone-propranolol, or placebo-placebo. Participants provided threat assessments for angry and neutral human faces on a baseline day, and immediately after stress induction on a testing day.
RESULTS


With both systems responding normally to stress (placebo-placebo), threat assessment was higher for neutral faces compared with angry. Compared with placebo, SNS suppression resulted in increased threat assessment for angry faces. HPA suppression resulted in decreased threat assessment for neutral and angry faces. When both systems were suppressed, there was an increase in threat assessment for angry faces, and no difference from placebo for neutral.
CONCLUSION


Our findings demonstrated that when intact, the biological stress systems adaptively support organisms during stress by focusing attention towards specific stimuli that are relevant to the threat. Dysregulations of the stress systems result in important system specific consequences on threat evaluation, such that suppression of either stress system alone resulted in reduced threat assessment for contextually relevant threatening stimuli, whereas when both systems were suppressed, individuals appear indiscriminately attentive to all potential threats in the environment, resulting in increased threat processing of both contextually relevant and irrelevant stimuli. Given that stress-related psychopathologies have been associated with dysregulations of the stress systems and biased responses to social threat, a systematic understanding of the mechanisms that underlie how stress systems modulate social threat assessment is needed, and can provide important insights into the cognitive processes that are involved in the development and maintenance of stress-related psychopathologies.",2020,"When both systems were suppressed, there was an increase in threat assessment for angry faces, and no difference from placebo for neutral.
","['acute stress', 'One hundred sixty-one healthy men and women']","['stress (placebo-placebo', 'placebo, SNS suppression', 'placebo', 'placebo conditions: dexamethasone-placebo, placebo-propranolol, dexamethasone-propranolol, or placebo-placebo']","['threat assessment for neutral and angry faces', 'HPA suppression', 'threat assessment for angry faces']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0271738', 'cui_str': 'Hypocortisolism secondary to another disorder'}]",161.0,0.0668689,"When both systems were suppressed, there was an increase in threat assessment for angry faces, and no difference from placebo for neutral.
","[{'ForeName': 'Nida', 'Initials': 'N', 'LastName': 'Ali', 'Affiliation': 'Department of Psychology, McGill University, 2001 Avenue McGill College, Montreal, H3A 1G1, Canada. nida.ali@mail.mcgill.ca.'}, {'ForeName': 'Cory', 'Initials': 'C', 'LastName': 'Cooperman', 'Affiliation': 'Department of Psychology, McGill University, 2001 Avenue McGill College, Montreal, H3A 1G1, Canada.'}, {'ForeName': 'Jonas P', 'Initials': 'JP', 'LastName': 'Nitschke', 'Affiliation': 'Department of Psychology, McGill University, 2001 Avenue McGill College, Montreal, H3A 1G1, Canada.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Baldwin', 'Affiliation': 'Department of Psychology, McGill University, 2001 Avenue McGill College, Montreal, H3A 1G1, Canada.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Pruessner', 'Affiliation': 'Faculty of Medicine, McGill Centre for Studies in Aging, McGill University, Montreal, Canada.'}]",Psychopharmacology,['10.1007/s00213-020-05591-z']
930,32470863,The effect of Korean Red Ginseng on sarcopenia biomarkers in type 2 diabetes patients.,"BACKGROUND


The elderly population is growing rapidly worldwide and sarcopenia, which is considered as a new geriatric syndrome has become an important issue. In particular, diabetes is known to be an important risk factor for sarcopenia. In this study, we investigated the effects of Korean Red Ginseng (KRG) on biomarkers of sarcopenia in middle and old age diabetes patients.
PATIENTS AND METHODS


This study was a randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to either the placebo or KRG group and took corresponding tablets for 24 weeks. The primary outcomes were changes in sarcopenia biomarkers at week 24. Secondary outcomes were changes in inflammatory and antioxidant markers and lean body mass at week 24.
RESULTS


Fifty-nine patients completed the study. Follistatin and sex hormone binding globulin (SHBG) were significantly improved in KRG group. In the subgroup analysis, female postmenopausal patients over the age of 55 showed a significant improvement in serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT) after the administration of KRG.
CONCLUSION


Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women. A further, larger population study with a longer follow-up period is warranted to verify and understand the effects of KRG on sarcopenia.",2020,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","['type 2 diabetes patients', 'Fifty-nine patients completed the study', 'middle and old age diabetes patients', 'old postmenopausal women']","['placebo or KRG', 'Korean Red Ginseng (KRG', 'KRG', 'Korean Red Ginseng', 'placebo']","['serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT', 'sarcopenia biomarkers', 'changes in inflammatory and antioxidant markers and lean body mass', 'changes in sarcopenia biomarkers', 'follistatin and SHBG levels', 'Follistatin and sex hormone binding globulin (SHBG']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}]","[{'cui': 'C0455307', 'cui_str': 'Serum sex hormone binding globulin measurement'}, {'cui': 'C0060623', 'cui_str': 'Activin-Binding Protein'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}]",59.0,0.135337,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","[{'ForeName': 'Kahui', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea.'}, {'ForeName': 'Chul Woo', 'Initials': 'CW', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea.'}, {'ForeName': 'YuSik', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: cromoton@yuhs.ac.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Nam', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: jisunn@yuhs.ac.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104108']
931,32473556,Functional training with blood occlusion influences muscle quality indices in older adults.,"OBJECTIVES


This study aimed to determine if functional training with blood flow restriction (BFR) has a greater effect on muscle quality indices and performance of older men when compared to functional training without BFR.
MATERIALS AND METHODS


Thirty men (67.7 ± 5.8 years) were randomly assigned to one of the following three groups: functional training (FT), functional training with blood flow restriction (FTBFR), and control (C). Participants in both experimental groups trained three sessions per week for six weeks. The training program included eleven body exercises, which were performed in 2-4 sets of 10 repetitions. FTBFR group wore pneumatic cuffs on their extremities that begun with 50 % of estimated arterial occlusion pressure and increased by 10 % every 2 weeks. Before and after the intervention period, subjects completed a series of tests to assess physical performances along with changes serum muscle quality indices.
RESULTS


A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05). In addition, the levels of CAF in FTBFR group was significantly lower compared to control group. Moreover, the circulatory levels of N-terminal propeptide type III collagen (P3NP) were reduced significantly in FT and C groups (p ≤ 0.05) but did not statistically differ from baseline in FTBFR group (p > 0.05). These changes were accompanied by significant improvements in dynamic strength, flexibility, static, and dynamic balance in both training groups (p ≤ 0.01).
CONCLUSIONS


The finding showed greater improvements in muscle quality indices and functional performance of older men when exercises performed with BFR.",2020,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"['Thirty men (67.7\u202f±\u202f5.8 years', 'older adults', 'older men']","['Functional training with blood occlusion', 'FTBFR group wore pneumatic cuffs', 'functional training with blood flow restriction (BFR', 'functional training (FT), functional training with blood flow restriction (FTBFR), and control (C']","['circulatory levels of N-terminal propeptide type III collagen (P3NP', 'dynamic strength, flexibility, static, and dynamic balance', 'serum C-terminal Agrin Fragment (CAF) levels', 'arterial occlusion pressure', 'muscle quality indices and functional performance', 'levels of CAF']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009332', 'cui_str': 'Collagen type III'}, {'cui': 'C0072054', 'cui_str': 'procollagen Type III-N-terminal peptide'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4077009', 'cui_str': 'C-terminal agrin fragment'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0143913,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"[{'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Bigdeli', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Dehghaniyan', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran. Electronic address: amani_sadegh@khu.ac.ir.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rajabi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Gahreman', 'Affiliation': 'College of Health and Human Sciences, Charles Darwin University, Darwin, Northern Territory, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104110']
932,32473654,Endometrial scratch vs no intervention in egg donation cycles: the ENDOSCRATCH trial protocol.,"BACKGROUND


The effects of endometrial scratching (ES) on embryo implantation have been studied for many years. Several studies have shown better outcomes when performed on patients undergoing intrauterine insemination and in vitro fertilization (IVF) cycles, but many other reports have not been able to find these differences. As far as cycles with donor eggs are concerned, reported evidence is scarce. Our aim in this trial is to determine if ES is useful for those patients undergoing IVF cycles with donor eggs, in order to assure a greater homogeneity in embryo quality and endometrial preparation.
METHODS


This single centre randomized controlled trial will include patients undergoing an egg donation cycle, meeting the inclusion criteria and who accept to participate in the study. Once informed consent is signed, patients will be randomly allocated to the study arm (group A) and then receive ES in the luteal phase of the cycle prior to embryo transfer, or the control arm (group B) without any intervention. All cycle data will be collected and analyzed to obtain the clinical pregnancy and the live birth rates in the two groups.
DISCUSSION


Several studies have tried to determine the effectiveness of an ES in IVF cycles, but it is still unclear due to the heterogeneity of these reports. The aim of this study is to determine if there are differences in clinical pregnancy rate and live birth rate in egg donor cycles, when comparing an ES performed in the preceding luteal phase versus no intervention, given that embryo quality and endometrial preparation protocols will be comparable.
TRIAL REGISTRATION


Ethical approval of version 2.0 of this trial was obtained on the 13th January 2017. It was retrospectively registered on the 5th April 2017 as the ENDOSCRATCH Trial (NCT03108157) in ClinicalTrials.gov.",2020,"Our aim in this trial is to determine if ES is useful for those patients undergoing IVF cycles with donor eggs, in order to assure a greater homogeneity in embryo quality and endometrial preparation.
","['patients undergoing intrauterine insemination and in vitro fertilization (IVF) cycles', 'patients undergoing IVF cycles with donor eggs', 'patients undergoing an egg donation cycle, meeting the inclusion criteria and who accept to participate in the study']","['Endometrial scratch vs no intervention', 'endometrial scratching (ES']","['live birth rates', 'clinical pregnancy rate and live birth rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4049214', 'cui_str': 'Endometrial scratching'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",,0.165196,"Our aim in this trial is to determine if ES is useful for those patients undergoing IVF cycles with donor eggs, in order to assure a greater homogeneity in embryo quality and endometrial preparation.
","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Izquierdo', 'Affiliation': 'ProcreaTec Fertility Clinic, Madrid, Spain. izquierdo.alexandra@yahoo.es.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'de la Fuente', 'Affiliation': 'Human Reproduction Unit, Department of Obstetrics and Gynecology, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Spies', 'Affiliation': 'ProcreaTec Fertility Clinic, Madrid, Spain.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rayward', 'Affiliation': 'ProcreaTec Fertility Clinic, Madrid, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'López', 'Affiliation': 'ProcreaTec Fertility Clinic, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lora', 'Affiliation': 'Clinical Research Unit (imas12-CIBERESP). University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Galindo', 'Affiliation': 'Fetal Medicine Unit - Maternal and Child Health and Development Network (Red SAMID-RD12/0026/0016). Department of Obstetrics and Gynecology. University Hospital 12 de Octubre. 12 de Octubre Research Institute (imas12), Complutense University of Madrid, Madrid, Spain.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-02958-0']
933,32483056,Acupuncture of different treatment frequencies in knee osteoarthritis: a pilot randomised controlled trial.,"This 16-week randomised controlled trial (8-week treatment followed by 8-week follow-up) evaluated the symptomatic improvement in patients with knee osteoarthritis on 3 sessions per week of acupuncture (TSWA) compared to 1 session per week of acupuncture (OSWA). Sixty participants were randomised to either the TSWA or the OSWA group in a 1:1 ratio. The primary outcome was response rate, defined as the percentage of participants achieving ≥2 points decrease on the numerical rating scale (NRS) and ≥6 points decrease in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score at week 8 compared with baseline. Additional outcomes included response rates at weeks 4 and 16, NRS, WOMAC, Patient Global Assessment, 12-item Short Form Health Survey (SF-12), and treatment credibility and expectancy. No significant difference was seen in response rate between TSWA and OSWA groups at week 8 (64.7% vs 50.0%; difference, 14.7 percentage points [95% CI, -10.1 to 39.4 percentage points], P = 0.435). At weeks 4 and 16, the TSWA group had higher response rates than the OSWA group (week-4: difference, 44.7 percentage points [95% CI, 23.2-66.1 percentage points], P = 0.001; week-16: difference, 46.0 percentage points [95% CI, 24.4-67.6 percentage points], P < 0.001). Participants in the TSWA group experienced significantly greater improvements in NRS, WOMAC function, and Patient Global Assessment than those in the OSWA group. There were no significant between-group differences in WOMAC stiffness and SF-12. In summary, TSWA immediately improved knee pain and dysfunction compared with OSWA. In addition, the benefit of TSWA persists throughout follow-up.",2020,"Participants in TSWA group experienced significantly greater improvements in NRS, WOMAC function and PGA than OSWA group.","['knee osteoarthritis', 'Sixty participants', 'patients with knee osteoarthritis (KOA']","['OSWA', 'acupuncture (OSWA', 'Acupuncture', 'TSWA', 'acupuncture (TSWA']","['response rate, defined as the percentage of participants achieving ≥2 points decrease on the numerical rating scale (NRS) and ≥6 points decrease in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score', 'response rates', 'response rates at weeks 4 and 16, NRS, WOMAC, Patient Global Assessment (PGA), 12-item', 'knee pain and dysfunction', 'NRS, WOMAC function and PGA', 'response rate', 'WOMAC stiffness and SF-12']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",60.0,0.126622,"Participants in TSWA group experienced significantly greater improvements in NRS, WOMAC function and PGA than OSWA group.","[{'ForeName': 'Lu-Lu', 'Initials': 'LL', 'LastName': 'Lin', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Tu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, affiliated with Capital Medical University, Beijing, China.'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jing-Wen', 'Initials': 'JW', 'LastName': 'Yang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Guang-Xia', 'Initials': 'GX', 'LastName': 'Shi', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jin-Ling', 'Initials': 'JL', 'LastName': 'Li', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jia-Kai', 'Initials': 'JK', 'LastName': 'Shao', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, affiliated with Capital Medical University, Beijing, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}]",Pain,['10.1097/j.pain.0000000000001940']
934,32487971,"Effects of Trunk Stabilization Exercise While Wearing a Pelvic Compression Belt on Walking and Balancing Abilities in Patients With Stroke: An Assessor Blinded, Preliminary, Randomized, Controlled Study.","OBJECTIVE


The aim of this study was to investigate the effects of wearing a pelvic compression belt during trunk stability exercise on balance and gait ability in patients with stroke.
DESIGN


Thirty-six patients with stroke participated and were randomly allocated to three groups: the paretic group (trunk stability exercise wearing a pelvic belt on the paretic side), the nonparetic group (trunk stability exercise wearing a pelvic belt on the nonparetic side), or the control group (trunk stability exercise without a pelvic belt). Walking and balancing abilities were assessed before and after trunk stabilization exercise.
RESULTS


Significantly larger gains were identified in the paretic group than in the control group for all variables (P < 0.017). In addition, significantly larger gains were observed in the paretic group than in the nonparetic group (P < 0.017) (limit of stability, 15.6%; stance phase of paretic side, 4.1%; 10-m walking test, -10.1%; 6-min walking test, 4.6%).
CONCLUSION


Wearing a pelvic belt on the paretic side during trunk stabilization exercise seems to be more effective at improving the balancing and walking abilities of patients with stroke than wearing a pelvic compression belt on the nonparetic side or not wearing a pelvic belt.",2020,Significantly larger gains were identified in the paretic group than in the control group for all variables (p < .017).,"['patients whit stroke', 'Thirty-six patients with stroke participated', 'patients with stroke']","['wearing a pelvic compression belt during trunk stability exercise', 'paretic group (trunk stability exercise wearing a pelvic belt on paretic side), the non-paretic group (trunk stability exercise wearing a pelvic belt on non-paretic side), or the control group (trunk stability exercise without a pelvic belt', 'trunk stabilization exercise']","['walking and balancing abilities', 'Walking and balancing abilities', 'larger gains', 'balance and gait ability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4319606', 'cui_str': '36'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",36.0,0.0276591,Significantly larger gains were identified in the paretic group than in the control group for all variables (p < .017).,"[{'ForeName': 'Yoon-Hee', 'Initials': 'YH', 'LastName': 'Choi', 'Affiliation': 'From the Department of Physical Therapy, Graduate School of Daejeon University, Daejeon, Republic of Korea (Y-HC, N-HK); Department of Physical Therapy, College of Health and Medical Science, Cheongju University, Cheongju, Republic of Korea (S-MS); and Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Daejeon, Republic of Korea (Y-JC).'}, {'ForeName': 'Nan-Hyang', 'Initials': 'NH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Sung-Min', 'Initials': 'SM', 'LastName': 'Son', 'Affiliation': ''}, {'ForeName': 'Yong-Jun', 'Initials': 'YJ', 'LastName': 'Cha', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001484']
935,32583013,(Lack of) Effects of noradrenergic stimulation on human working memory performance.,"RATIONALE


Working memory depends on prefrontal cortex functioning, which is particularly sensitive to levels of noradrenaline. Studies in non-human primates have shown that modest levels of noradrenaline improve working memory, and that higher levels of noradrenaline impair working memory performance. However, research in humans provided inconsistent findings concerning noradrenergic effects on working memory.
OBJECTIVE


The present study aimed at assessing dose-dependent effects of yohimbine, an alpha-2 adrenoceptor antagonist, on working memory performance in healthy humans. We further aimed to explore a potential interactive effect between noradrenergic arousal and lack of control over aversive events on working memory performance.
METHODS


We used a double-blind, fully crossed, placebo-controlled, between-subject design. Participants (N = 121) performed an adaptive n-back task before and after oral administration of either a placebo, 20 mg, or 40 mg yohimbine and a manipulation of controllability, during which participants could either learn to avoid electric shocks (controllability groups), had no instrumental control over shock administration (uncontrollability groups), or did not receive any shocks (no-shock control group).
RESULTS


While no significant results of noradrenergic stimulation through yohimbine were obtained using conventional frequentist analyses, additional Bayesian analyses provided strong evidence for the absence of an association between pharmacological treatment and working memory performance. We further observed no effect of controllability and no interaction between noradrenergic stimulation and the manipulation of controllability.
CONCLUSIONS


Our results suggest that noradrenergic stimulation through yohimbine does not affect (non-spatial) working memory in healthy human participants.",2020,Our results suggest that noradrenergic stimulation through yohimbine does not affect (non-spatial) working memory in healthy human participants.,"['healthy humans', 'healthy human participants']","['yohimbine', 'placebo, 20\xa0mg, or 40\xa0mg yohimbine and a manipulation of controllability, during which participants could either learn to avoid electric shocks (controllability groups), had no instrumental control over shock administration (uncontrollability groups), or did not receive any shocks (no-shock control group', 'noradrenergic stimulation']","['noradrenergic stimulation', 'human working memory performance']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0724441', 'cui_str': 'yohimbine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0013781', 'cui_str': 'Exposure to electric current, with passage of current through tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",,0.15747,Our results suggest that noradrenergic stimulation through yohimbine does not affect (non-spatial) working memory in healthy human participants.,"[{'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Wanke', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, 20146, Hamburg, Germany.'}, {'ForeName': 'Jana Christina', 'Initials': 'JC', 'LastName': 'Müller', 'Affiliation': 'Department of Psychiatry, University Clinic Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Wiedemann', 'Affiliation': 'Department of Psychiatry, University Clinic Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Schwabe', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, 20146, Hamburg, Germany. Lars.Schwabe@uni-hamburg.de.'}]",Psychopharmacology,['10.1007/s00213-020-05590-0']
936,32583295,Evaluating the Incidence of Opioid-Induced Respiratory Depression Associated with Oliceridine and Morphine as Measured by the Frequency and Average Cumulative Duration of Dosing Interruption in Patients Treated for Acute Postoperative Pain.,"BACKGROUND AND OBJECTIVE


Opioid-induced respiratory depression (OIRD) is a potentially fatal complication associated with conventional opioids. Currently, there is a paucity of validated endpoints available to measure respiratory safety. Oliceridine, an investigational intravenous (IV) opioid, is a G-protein selective μ-agonist with limited activity on β-arrestin2, a signaling pathway associated with adverse events including OIRD. In controlled phase III trials, oliceridine 0.35 mg and 0.5 mg demand doses demonstrated comparable analgesia to morphine 1 mg with favorable improvements in respiratory safety. In this exploratory analysis, we report dosing interruption (DI) and average cumulative duration of DI (CDDI) for both oliceridine and morphine.
METHODS


Patients requiring analgesia after bunionectomy or abdominoplasty were randomized to IV demand doses of placebo, oliceridine (0.1 mg, 0.35 mg, or 0.5 mg), or morphine (1 mg), administered via patient-controlled analgesia (PCA), following a loading dose (oliceridine 1.5 mg, morphine 4 mg, volume-matched placebo) with a 6-min lockout interval. Certified nurse anesthetists monitored each patient and withheld study medication according to the patient's respiratory status. For each patient, the duration of all DIs was summed and reported as CDDI. A zero-inflated gamma mixture model was used to compute the mean CDDI for each treatment.
RESULTS


Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%). The CDDI was also lower across all demand doses of oliceridine versus morphine.
CONCLUSION


Using DI as a surrogate for OIRD indicates improved respiratory safety with oliceridine versus morphine that merits further investigation.",2020,"RESULTS


Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%).","['Patients requiring analgesia after bunionectomy or abdominoplasty', 'Patients Treated for Acute Postoperative Pain']","['Oliceridine and Morphine', 'oliceridine', 'placebo, oliceridine', 'morphine (1\xa0mg), administered via patient-controlled analgesia (PCA), following a loading dose (oliceridine 1.5\xa0mg, morphine 4\xa0mg, volume-matched placebo', 'oliceridine and morphine', 'Oliceridine', 'morphine']","['respiratory safety', 'average cumulative duration of DI (CDDI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1542057', 'cui_str': 'Silver bunionectomy'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]",,0.0289906,"RESULTS


Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%).","[{'ForeName': 'Sabry', 'Initials': 'S', 'LastName': 'Ayad', 'Affiliation': 'Department of Anesthesiology, Cleveland Clinic, Outcomes Research, Anesthesiology Institute, Fairview Hospital, 18101 Lorain Avenue, Cleveland, OH, 44111, USA. Saayad@ccf.org.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Demitrack', 'Affiliation': 'Clinical Operations and Medical Affairs, Trevena Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Burt', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Michalsky', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wase', 'Affiliation': 'Clinical Operations and Medical Affairs, Trevena Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fossler', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'Department of Anesthesiology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}]",Clinical drug investigation,['10.1007/s40261-020-00936-0']
937,32591590,Effects of combining constraint-induced movement therapy and action-observation training on upper limb kinematics in children with unilateral cerebral palsy: a randomized controlled trial.,"Modified constraint-induced movement therapy (mCIMT) improves upper limb (UL) motor execution in unilateral cerebral palsy (uCP). As these children also show motor planning deficits, action-observation training (AOT) might be of additional value. Here, we investigated the combined value of AOT to mCIMT on UL kinematics in children with uCP in a randomized controlled trial. Thirty-six children with uCP completed an UL kinematic and clinical evaluation after participating in a 9-day mCIMT camp wearing a splint for 6 h/day. The experimental group (mCIMT + AOT, n = 20) received 15 h of AOT, i.e. video-observation and execution of unimanual tasks. The control group (mCIMT + placebo, n = 16) watched biological-motion free videos and executed the same tasks. We examined changes in motor control (movement duration, peak velocity, time-to-peak velocity, and trajectory straightness) and kinematic movement patterns (using Statistical Parametric Mapping) during the execution of three unimanual, relevant tasks before the intervention, after and at 6 months follow-up. Adding AOT to mCIMT mainly affected movement duration during reaching, whereas little benefit is seen on UL movement patterns. mCIMT, with or without AOT, improved peak velocity and trajectory straightness, and proximal movement patterns. Clinical and kinematic improvements are poorly related. Although there seem to be limited benefits of AOT to CIMT on UL kinematics, our results support the inclusion of kinematics to capture changes in motor control and movement patterns of the proximal joints.",2020,"The control group (mCIMT + placebo, n = 16) watched biological-motion free videos and executed the same tasks.","['children with unilateral cerebral palsy', 'children with uCP', 'unilateral cerebral palsy (uCP', 'Thirty-six children with uCP completed an UL kinematic and clinical evaluation after participating in a 9-day mCIMT camp wearing a splint for 6\xa0h/day']","['15\xa0h of AOT, i.e. video-observation and execution of unimanual tasks', 'control group (mCIMT\u2009+\u2009placebo, n\u2009=\u200916) watched biological-motion free videos and executed the same tasks', 'combining constraint-induced movement therapy and action-observation training', 'AOT to mCIMT', 'Modified constraint-induced movement therapy (mCIMT']","['peak velocity and trajectory straightness, and proximal movement patterns', 'motor control (movement duration, peak velocity, time-to-peak velocity, and trajectory straightness) and kinematic movement patterns', 'upper limb kinematics', 'upper limb (UL) motor execution']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0038009', 'cui_str': 'Splint'}]","[{'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0427096', 'cui_str': 'Patterning of movement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}]",36.0,0.0555808,"The control group (mCIMT + placebo, n = 16) watched biological-motion free videos and executed the same tasks.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Simon-Martinez', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven, 3000, Leuven, Belgium. cristina.simon@kuleuven.be.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Mailleux', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven, 3000, Leuven, Belgium.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Jaspers', 'Affiliation': 'Neural Control of Movement Lab, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Ortibus', 'Affiliation': 'Department of Development and Regeneration, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Kaat', 'Initials': 'K', 'LastName': 'Desloovere', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven, 3000, Leuven, Belgium.'}, {'ForeName': 'Katrijn', 'Initials': 'K', 'LastName': 'Klingels', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven, 3000, Leuven, Belgium.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Feys', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven, 3000, Leuven, Belgium.'}]",Scientific reports,['10.1038/s41598-020-67427-2']
938,32591594,Cold atmospheric plasma as an effective method to treat diabetic foot ulcers: A randomized clinical trial.,"Cold atmospheric plasma (CAP) was shown to decrease bacterial load in chronic wounds. It was also presented as a novel approach to healing wounds in both in vitro and in vivo experiments. We aimed to examine the first randomized clinical trial for the use of CAP in diabetic foot ulcers. Patients (n = 44) were randomly double-blinded, and assigned to receive standard care (SC, n = 22) without or with CAP, to be applied three times a week for three consecutive weeks (SC + CAP, n = 22), using block randomization with mixing block sizes of four. The trial was conducted at the Diabetes Research Center in Tehran, Iran. CAP was generated from ionized helium gas in ambient air, and driven by a high voltage (10 kV) and high frequency (6 kHz) power supply. Primary outcomes were wound size, number of cases reaching wound size of <0.5, and a bacterial load after over three weeks of treatment. CAP treatment effectively reduced the fraction of wound size (p = 0.02). After three weeks, the wounds to reach fraction wound size of ≤0.5 was significantly greater in the SC + CAP group (77.3%) compared to the SC group (36.4%) (p = 0.006). The mean fraction of bacterial load counted in each session 'after CAP exposure' was significantly less than 'before exposure' measures. CAP can be an efficient method to accelerate wound healing in diabetic foot ulcers, with immediate antiseptic effects that do not seem to last long.",2020,The mean fraction of bacterial load counted in each session 'after CAP exposure' was significantly less than 'before exposure' measures.,"['Diabetes Research Center in Tehran, Iran', 'diabetic foot ulcers', 'Patients (n\u2009=\u200944']","['Cold atmospheric plasma (CAP', 'Cold atmospheric plasma', 'CAP', 'standard care (SC, n\u2009=\u200922) without or with CAP']","['mean fraction of bacterial load', 'wound size, number of cases reaching wound size of <0.5, and a bacterial load', 'fraction of wound size']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0444500', 'cui_str': '0.5'}]",44.0,0.0759249,The mean fraction of bacterial load counted in each session 'after CAP exposure' was significantly less than 'before exposure' measures.,"[{'ForeName': 'Shahriar', 'Initials': 'S', 'LastName': 'Mirpour', 'Affiliation': 'Department of Applied physics, Eindhoven university of Technology, Eindhoven, The Netherlands.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Fathollah', 'Affiliation': 'Department of Applied physics, Amirkabir university of Technology, Tehran, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Mansouri', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran. mansorip@sina.tums.ac.ir.'}, {'ForeName': 'Bagher', 'Initials': 'B', 'LastName': 'Larijani', 'Affiliation': 'Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Ghoranneviss', 'Affiliation': 'Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohajeri Tehrani', 'Affiliation': 'Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran. mrmohajeri@tums.ac.ir.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Amini', 'Affiliation': 'Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran. mramini@tums.ac.ir.'}]",Scientific reports,['10.1038/s41598-020-67232-x']
939,32596938,Re: Incidence and characteristics of pregnancy-related death across ten low- and middle-income geographical regions: secondary analysis of a cluster randomised controlled trial: The underestimated scourge of eclampsia in low-income countries.,,2020,,[],[],[],[],[],[],,0.361711,,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Scioscia', 'Affiliation': 'Department of Obstetrics and Gynaecology, Policlinico Hospital, Abano Terme, Padua, Italy.'}, {'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Somigliana', 'Affiliation': ""Università degli Studi di Milano and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Sartie', 'Initials': 'S', 'LastName': 'Kenneh', 'Affiliation': 'Ministry of Health and Sanitation, Government of Sierra Leone, Freetown, Sierra Leone.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Robillard', 'Affiliation': ""Service de Néonatologie-Centre d'Etudes Périnatales Océan Indien (CEPOI), Centre Hospitalier Universitaire Sud Réunion, Saint-Pierre Cedex, La Réunion, France.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Dalle Carbonare', 'Affiliation': 'Department of Obstetrics and Gynaecology, Policlinico Hospital, Abano Terme, Padua, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Putoto', 'Affiliation': 'Operational Research Unit, Doctors with Africa CUAMM, Padua, Italy.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16351']
940,32593293,"The Promotoer, a brain-computer interface-assisted intervention to promote upper limb functional motor recovery after stroke: a study protocol for a randomized controlled trial to test early and long-term efficacy and to identify determinants of response.","BACKGROUND


Stroke is a leading cause of long-term disability. Cost-effective post-stroke rehabilitation programs for upper limb are critically needed. Brain-Computer Interfaces (BCIs) which enable the modulation of Electroencephalography (EEG) sensorimotor rhythms are promising tools to promote post-stroke recovery of upper limb motor function. The ""Promotoer"" study intends to boost the application of the EEG-based BCIs in clinical practice providing evidence for a short/long-term efficacy in enhancing post-stroke hand functional motor recovery and quantifiable indices of the participants response to a BCI-based intervention. To these aims, a longitudinal study will be performed in which subacute stroke participants will undergo a hand motor imagery (MI) training assisted by the Promotoer system, an EEG-based BCI system fully compliant with rehabilitation requirements.
METHODS


This longitudinal 2-arm randomized controlled superiority trial will include 48 first ever, unilateral, subacute stroke participants, randomly assigned to 2 intervention groups: the BCI-assisted hand MI training and a hand MI training not supported by BCI. Both interventions are delivered (3 weekly session; 6 weeks) as add-on regimen to standard intensive rehabilitation. A multidimensional assessment will be performed at: randomization/pre-intervention, 48 h post-intervention, and at 1, 3 and 6 month/s after end of intervention. Primary outcome measure is the Fugl-Meyer Assessment (FMA, upper extremity) at 48 h post-intervention. Secondary outcome measures include: the upper extremity FMA at follow-up, the Modified Ashworth Scale, the Numeric Rating Scale for pain, the Action Research Arm Test, the National Institute of Health Stroke Scale, the Manual Muscle Test, all collected at the different timepoints as well as neurophysiological and neuroimaging measures.
DISCUSSION


We expect the BCI-based rewarding of hand MI practice to promote long-lasting retention of the early induced improvement in hand motor outcome and also, this clinical improvement to be sustained by a long-lasting neuroplasticity changes harnessed by the BCI-based intervention. Furthermore, the longitudinal multidimensional assessment will address the selection of those stroke participants who best benefit of a BCI-assisted therapy, consistently advancing the transfer of BCIs to a best clinical practice.
TRIAL REGISTRATION


Name of registry: BCI-assisted MI Intervention in Subacute Stroke (Promotoer).
TRIAL REGISTRATION NUMBER


NCT04353297 ; registration date on the ClinicalTrial.gov platform: April, 15/2020.",2020,"Primary outcome measure is the Fugl-Meyer Assessment (FMA, upper extremity) at 48 h post-intervention.","['48 first ever, unilateral, subacute stroke participants', 'subacute stroke participants']","['hand motor imagery (MI) training assisted by the Promotoer system, an EEG-based BCI system fully compliant with rehabilitation requirements', 'Brain-Computer Interfaces (BCIs', 'BCI-assisted MI Intervention', 'BCI-assisted hand MI training and a hand MI training not supported by BCI']","['Fugl-Meyer Assessment (FMA, upper extremity', ' the upper extremity FMA at follow-up, the Modified Ashworth Scale, the Numeric Rating Scale for pain, the Action Research Arm Test, the National Institute of Health Stroke Scale, the Manual Muscle Test, all collected at the different timepoints as well as neurophysiological and neuroimaging measures']","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2742590', 'cui_str': '2-benzylidene-3-(cyclohexylamino)-2,3-dihydro-1H-inden-1-one'}, {'cui': 'C0566588', 'cui_str': 'Compliant'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C3494288', 'cui_str': 'Brain-Computer Interface'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0451362', 'cui_str': 'Oxford grading scale for muscle strength'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",48.0,0.0693517,"Primary outcome measure is the Fugl-Meyer Assessment (FMA, upper extremity) at 48 h post-intervention.","[{'ForeName': 'Donatella', 'Initials': 'D', 'LastName': 'Mattia', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy. d.mattia@hsantalucia.it.'}, {'ForeName': 'Floriana', 'Initials': 'F', 'LastName': 'Pichiorri', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Colamarino', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Masciullo', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Morone', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Jlenia', 'Initials': 'J', 'LastName': 'Toppi', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Iolanda', 'Initials': 'I', 'LastName': 'Pisotta', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Tamburella', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lorusso', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Paolucci', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Puopolo', 'Affiliation': 'Istituto Superiore di Sanità, Rome, Italy.'}, {'ForeName': 'Febo', 'Initials': 'F', 'LastName': 'Cincotti', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Molinari', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}]",BMC neurology,['10.1186/s12883-020-01826-w']
941,32601731,Metformin use in prediabetes: is earlier intervention better?,"AIM


The aim of this study was to investigate the effectiveness of metformin in diabetes prevention in a prediabetic population across a range of fasting plasma glucose (FPG) levels at baseline. A secondary aim was to assess the effectiveness of metformin in preventing diabetes in those participants where impaired fasting glucose (IFG) was relatively more pronounced as opposed to impaired glucose tolerance (IGT).
METHODS


Participants randomised to metformin and placebo arms in the Diabetes Prevention Program study were stratified into cohorts according to level of FPG at baseline. Cumulative incidence of diabetes for the different cohorts was assessed. Change in FPG, insulin sensitivity, and levels of fasting insulin and proinsulin for the different cohorts were also calculated.
RESULTS


The largest reductions in incidence of diabetes and FPG occurred within prediabetic persons with a higher level of FPG at baseline. Metformin was able to stabilise insulin sensitivity in every stratified sub-cohort except one. Sub-cohorts which had higher levels of insulin sensitivity at baseline experienced the largest increases in insulin sensitivity. Metformin reduced the incidence of diabetes by 43% (RR 0.57, CI 0.4-0.9) in those prediabetic persons whose IFG was more pronounced compared to a 26% (RR 0.74 CI 0.7-0.8) when all participants in the study were included.
CONCLUSION


The largest reductions in both incidence of diabetes and FPG occurred in prediabetic persons with a higher level of FPG at baseline. Metformin was able to stabilise insulin sensitivity and was more effective in persons with more pronounced IFG.",2020,"Metformin reduced the incidence of diabetes by 43% (RR 0.57, CI 0.4-0.9) in those prediabetic persons whose IFG was more pronounced compared to a 26% (RR 0.74 CI 0.7-0.8) when all participants in the study were included.
",['prediabetes'],"['Metformin', 'metformin and placebo', 'metformin']","['incidence of diabetes and FPG', 'incidence of diabetes', 'stabilise insulin sensitivity', 'Cumulative incidence of diabetes', 'Change in FPG, insulin sensitivity, and levels of fasting insulin and proinsulin', 'insulin sensitivity', 'glucose tolerance (IGT', 'diabetes and FPG', 'fasting plasma glucose (FPG) levels', 'fasting glucose (IFG']","[{'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0033362', 'cui_str': 'Proinsulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.0413712,"Metformin reduced the incidence of diabetes by 43% (RR 0.57, CI 0.4-0.9) in those prediabetic persons whose IFG was more pronounced compared to a 26% (RR 0.74 CI 0.7-0.8) when all participants in the study were included.
","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Warrilow', 'Affiliation': 'University of Canberra, Locked Bag 1, Canberra, ACT, 2601, Australia. andrew.warrilow@canberra.edu.au.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Somerset', 'Affiliation': 'University of Canberra, Locked Bag 1, Canberra, ACT, 2601, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Pumpa', 'Affiliation': 'University of Canberra, Locked Bag 1, Canberra, ACT, 2601, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fleet', 'Affiliation': 'The Australian National University, Canberra, ACT, 2600, Australia.'}]",Acta diabetologica,['10.1007/s00592-020-01559-9']
942,32609186,Effects of desensitizing products on the reduction of pain sensitivity caused by in-office tooth bleaching: a 24-week follow-up.,"OBJECTIVE


To clinically assess the effect of desensitizing gels and dentifrices on the reduction in pain sensitivity and color variation during tooth bleaching.
METHODOLOGY


A total of 108 volunteers were randomly separated into the following groups of n=12: GT/S-glycerine and thickener/sucralose; NF/S-potassium nitrate and sodium fluoride/sucralose; NA/S-potassium nitrate and arginine/sucralose; GT/AC-glycerine and thickener/arginine and calcium carbonate; NF/AC-potassium nitrate and sodium fluoride/arginine and calcium carbonate; NA/AC-potassium nitrate and arginine/arginine and calcium carbonate; GT/PN-glycerine and thickener/potassium nitrate; NF/PN-potassium nitrate and sodium fluoride/potassium nitrate; and NA/PN-potassium nitrate and arginine/potassium nitrate. Sensitivity was assessed with the numerical analogue scale, and color variation (ΔE) was measured with a spectrophotometer. The sensitivity values obtained were subjected to a multivariate analysis of variance (MANOVA) and color variation values were subjected to a randomized analysis of variance (p<0.05).
RESULTS


The NF/AC, NA/AC, NF/PN, and NA/PN groups presented lower sensitivity values and reduced sensitivity compared to those of the other groups throughout the clinical sessions. None of the groups showed sensitivity at the 24-week assessment. Statistically, no significant difference were observed in the color values among the groups four weeks after the beginning of bleaching (p=0.074). Additionally, the color assessment of all groups was statistically similar four weeks (p=0.084) and 24 weeks (p=0.118) after the beginning.
CONCLUSION


Our results indicate that adding NF/S, NA/S, NF/AC, and NA/AC desensitizers to tooth bleaching protocols reduces pain sensitivity without affecting its effectiveness.",2020,"Additionally, the color assessment of all groups was statistically similar four weeks (p=0.084) and 24 weeks (p=0.118) after the beginning.
",['108 volunteers were randomly separated into the following groups of n=12'],"['desensitizing gels and dentifrices', 'fluoride/sucralose; NA/S-potassium nitrate and arginine/sucralose; GT/AC-glycerine and thickener/arginine and calcium carbonate; NF/AC-potassium nitrate and sodium fluoride/arginine and calcium carbonate; NA/AC-potassium nitrate and arginine/arginine and calcium carbonate; GT/PN-glycerine and thickener/potassium nitrate; NF/PN-potassium nitrate and sodium fluoride/potassium nitrate', 'desensitizing products', 'GT/S-glycerine and thickener/sucralose; NF/S-potassium nitrate and sodium']","['color values', 'numerical analogue scale, and color variation (ΔE', 'sensitivity values and reduced sensitivity', 'pain sensitivity', 'pain sensitivity and color variation', 'Sensitivity']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C0071772', 'cui_str': 'potassium nitrate'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}]",108.0,0.0167949,"Additionally, the color assessment of all groups was statistically similar four weeks (p=0.084) and 24 weeks (p=0.118) after the beginning.
","[{'ForeName': 'Josué Junior Araujo', 'Initials': 'JJA', 'LastName': 'Pierote', 'Affiliation': 'Universidade Estadual de Campinas, Faculdade de Odontologia de Piracicaba, Departamento de Dentística Restauradora, Piracicaba, Brasil.'}, {'ForeName': 'Lucia Trazzi', 'Initials': 'LT', 'LastName': 'Prieto', 'Affiliation': 'Universidade Estadual de Campinas, Faculdade de Odontologia de Piracicaba, Departamento de Dentística Restauradora, Piracicaba, Brasil.'}, {'ForeName': 'Carlos Tadeu Dos Santos', 'Initials': 'CTDS', 'LastName': 'Dias', 'Affiliation': 'Universidade de São Paulo, Escola Superior de Agricultura Luiz de Queiroz, Departamento de Engenharia Agronômica, Piracicaba, Brasil.'}, {'ForeName': 'João Victor Frazão', 'Initials': 'JVF', 'LastName': 'CÂmara', 'Affiliation': 'Universidade de São Paulo, Faculdade de Odontologia de Bauru, Departamento de Ciências Biológicas, Bauru, Brasil.'}, {'ForeName': 'Débora Alves Nunes Leite', 'Initials': 'DANL', 'LastName': 'Lima', 'Affiliation': 'Universidade Estadual de Campinas, Faculdade de Odontologia de Piracicaba, Departamento de Dentística Restauradora, Piracicaba, Brasil.'}, {'ForeName': 'Flávio Henrique Baggio', 'Initials': 'FHB', 'LastName': 'Aguiar', 'Affiliation': 'Universidade Estadual de Campinas, Faculdade de Odontologia de Piracicaba, Departamento de Dentística Restauradora, Piracicaba, Brasil.'}, {'ForeName': 'Luis Alexandre Maffei Sartini', 'Initials': 'LAMS', 'LastName': 'Paulillo', 'Affiliation': 'Universidade Estadual de Campinas, Faculdade de Odontologia de Piracicaba, Departamento de Dentística Restauradora, Piracicaba, Brasil.'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2019-0755']
943,32616309,"Neutrophil extracellular trapping and angiogenesis biomarkers after intravenous or inhalation anaesthesia with or without intravenous lidocaine for breast cancer surgery: a prospective, randomised trial.","BACKGROUND


Experimental and, retrospective, clinical data indicate that anaesthetic technique might influence the risk of metastasis after cancer surgery. Neutrophil extracellular trapping (NETosis) is an immunological mechanism strongly linked with increased metastatic risk. Similarly, vascular endothelial growth factor A is linked to angiogenesis implicated in recurrence. Therefore, we investigated the effect of four anaesthetic techniques on NETosis and angiogenic factors expression in women undergoing breast cancer resection.
METHODS


Women (n=120) undergoing primary breast tumour resection were randomly assigned to receive one of four anaesthetics: sevoflurane (S), sevoflurane plus i.v. lidocaine (SL), propofol (P), and propofol plus i.v. lidocaine (PL). Venous blood was collected before induction and 20-28 h after operation. Neutrophil myeloperoxidase and citrullinated histone H3, biomarkers of NETosis, and biomarkers of angiogenesis were measured by enzyme-linked immunosorbent assay.
RESULTS


Patient characteristic data and perioperative management did not differ between study groups. The anaesthetic technique including lidocaine decreased expression of citrullinated histone H3 compared with no lidocaine (109 [23] vs 125 [22] ng ml -1 , P=0.01 for SL and S and 98 [14] vs 130 [32] mg ml -1 , P=0.007, for PL and P, respectively). Similarly, myeloperoxidase was decreased by lidocaine (8.5 [3.4] vs 10.8 [1.8] ng ml -1 , P=0.03 for SL and S and 8.6 [3.1] vs 11.6 [2.5] ng ml -1 , P=0.01 for PL and P, respectively). Lidocaine also decreased expression of matrix metalloproteinase 3 (MMP3) but not MMP9, whichever anaesthetic was used. Vascular endothelial growth factor A concentrations were not significantly influenced by the anaesthetic technique.
CONCLUSIONS


I.V. perioperative lidocaine decreased postoperative expression of NETosis and MMP3, regardless of general anaesthetic technique. This supports the hypothesis that i.v. lidocaine during cancer surgery of curative intent might reduce recurrence.
CLINICAL TRIAL REGISTRATION


NCT02839668.",2020,"Lidocaine also decreased expression of matrix metalloproteinase 3 (MMP3) but not MMP9, whichever anaesthetic was used.","['Women (n=120) undergoing primary breast tumour resection', 'breast cancer surgery', 'women undergoing breast cancer resection']","['Lidocaine', 'lidocaine', 'anaesthetics: sevoflurane (S), sevoflurane plus i.v', 'lidocaine (SL), propofol (P), and propofol plus i.v', 'Neutrophil extracellular trapping (NETosis', 'inhalation anaesthesia with or without intravenous lidocaine', 'lidocaine (PL']","['expression of matrix metalloproteinase 3 (MMP3', 'Vascular endothelial growth factor', 'Neutrophil myeloperoxidase and citrullinated histone H3, biomarkers of NETosis, and biomarkers of angiogenesis', 'NETosis and angiogenic factors expression', 'postoperative expression of NETosis and MMP3', 'Venous blood', 'myeloperoxidase']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1458155', 'cui_str': 'Neoplasm of breast'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0164371', 'cui_str': 'Stromelysin 1'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0443783', 'cui_str': 'Neutrophil myeloperoxidase'}, {'cui': 'C0019647', 'cui_str': 'Histone H3'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002976', 'cui_str': 'Angiogenic Factor'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}]",,0.113979,"Lidocaine also decreased expression of matrix metalloproteinase 3 (MMP3) but not MMP9, whichever anaesthetic was used.","[{'ForeName': 'Elena V', 'Initials': 'EV', 'LastName': 'Galoș', 'Affiliation': '1st Department of Anaesthesiology and Intensive Care, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania; EU COST Action 15204: European Cooperation in Science and Technology, The European Platform for Outcomes Research into Perioperative Interventions during Surgery for Cancer: The EURO-PERISCOPE Network.'}, {'ForeName': 'Tiberiu-Florin', 'Initials': 'TF', 'LastName': 'Tat', 'Affiliation': 'Prof. Dr. Ion Chiricuta Institute of Oncology, Cluj-Napoca, Romania.'}, {'ForeName': 'Răzvan', 'Initials': 'R', 'LastName': 'Popa', 'Affiliation': 'Prof. Dr. Ion Chiricuta Institute of Oncology, Cluj-Napoca, Romania.'}, {'ForeName': 'Catalin-Iulian', 'Initials': 'CI', 'LastName': 'Efrimescu', 'Affiliation': 'Department of Anaesthesiology & Perioperative Medicine, Mater Misericordiae University Hospital, School of Medicine, University College Dublin, Dublin, Ireland; EU COST Action 15204: European Cooperation in Science and Technology, The European Platform for Outcomes Research into Perioperative Interventions during Surgery for Cancer: The EURO-PERISCOPE Network.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Finnerty', 'Affiliation': 'Department of Anaesthesiology & Perioperative Medicine, Mater Misericordiae University Hospital, School of Medicine, University College Dublin, Dublin, Ireland; EU COST Action 15204: European Cooperation in Science and Technology, The European Platform for Outcomes Research into Perioperative Interventions during Surgery for Cancer: The EURO-PERISCOPE Network.'}, {'ForeName': 'Donal J', 'Initials': 'DJ', 'LastName': 'Buggy', 'Affiliation': 'Department of Anaesthesiology & Perioperative Medicine, Mater Misericordiae University Hospital, School of Medicine, University College Dublin, Dublin, Ireland; Department of Outcomes Research, Anaesthesiology Institute, Cleveland Clinic, Cleveland, OH, USA; EU COST Action 15204: European Cooperation in Science and Technology, The European Platform for Outcomes Research into Perioperative Interventions during Surgery for Cancer: The EURO-PERISCOPE Network.'}, {'ForeName': 'Daniela C', 'Initials': 'DC', 'LastName': 'Ionescu', 'Affiliation': '1st Department of Anaesthesiology and Intensive Care, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania; Department of Outcomes Research, Anaesthesiology Institute, Cleveland Clinic, Cleveland, OH, USA; EU COST Action 15204: European Cooperation in Science and Technology, The European Platform for Outcomes Research into Perioperative Interventions during Surgery for Cancer: The EURO-PERISCOPE Network. Electronic address: daniela_ionescu@umfcluj.ro.'}, {'ForeName': 'Carmen M', 'Initials': 'CM', 'LastName': 'Mihu', 'Affiliation': 'Department of Histology, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.05.003']
944,32617646,The catechol-O-methyltransferase inhibitor tolcapone modulates alcohol consumption and impulsive choice in alcohol use disorder.,"RATIONALE


Individuals suffering from alcohol use disorder (AUD) demonstrate difficulty with decision-making and impulsivity that may be associated with impaired frontal cortical function. Therapeutics that enhance frontal dopamine tone could decrease impulsivity and in turn reduce alcohol consumption in individuals with AUD.
OBJECTIVES


To determine if the catechol-O-methyltransferase (COMT) inhibitor tolcapone can attenuate alcohol consumption in individuals with AUD and whether this attenuation correlates with tolcapone-induced changes in laboratory-based decision-making tasks.
METHODS


We used daily self-report and a novel group laboratory bar task to assess the effects of randomized double-blind crossover administration of tolcapone (100 mg TID for 5 days) on alcohol consumption and laboratory tasks assessing impulsivity in 55 non-treatment-seeking subjects with AUD.
RESULTS


Tolcapone significantly reduced self-reported alcohol consumption (t (54) = 2.05, p = 0.045). The effects of tolcapone on drinking significantly correlated with changes in impulsive decision-making, such that subjects with the greatest decrease in impulsive choice on tolcapone also reported the greatest decrease in alcohol consumption (r (45) = 0.40, p = 0.0053). We did not see effects of tolcapone on laboratory bar consumption. Adverse event (AE) reporting was low, with no significant difference in frequency or severity of AEs on tolcapone versus placebo.
CONCLUSIONS


These data demonstrate that COMT inhibitors such as tolcapone may be useful therapeutics for AUD.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02740582.",2020,"Adverse event (AE) reporting was low, with no significant difference in frequency or severity of AEs on tolcapone versus placebo.
","['individuals with AUD', '55 non-treatment-seeking subjects with AUD', 'Individuals suffering from alcohol use disorder (AUD']","['catechol-O-methyltransferase (COMT) inhibitor tolcapone', 'tolcapone']","['alcohol consumption and laboratory tasks assessing impulsivity', 'frequency or severity of AEs', 'self-reported alcohol consumption', 'Adverse event (AE) reporting', 'alcohol consumption']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0246330', 'cui_str': 'tolcapone'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.221006,"Adverse event (AE) reporting was low, with no significant difference in frequency or severity of AEs on tolcapone versus placebo.
","[{'ForeName': 'Allison R', 'Initials': 'AR', 'LastName': 'Coker', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA. allison.coker@ucsf.edu.'}, {'ForeName': 'Dawn N', 'Initials': 'DN', 'LastName': 'Weinstein', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Taylor A', 'Initials': 'TA', 'LastName': 'Vega', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Catriona S', 'Initials': 'CS', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Kayser', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Mitchell', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05599-5']
945,32473974,"Bimekizumab for patients with moderate to severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled, phase 2b extension study.","BACKGROUND


Dual neutralization of both interleukin 17A and 17F with the monoclonal antibody bimekizumab may have greater efficacy in psoriasis than neutralization of interleukin 17A alone.
OBJECTIVE


To provide longer-term efficacy and safety data for bimekizumab from a phase 2b extension study in patients with moderate to severe psoriasis (BE ABLE 2).
METHODS


After the 12-week initial study (BE ABLE 1), patients who had a 90% improvement in Psoriasis Area and Severity Index (PASI 90) at week 12 received bimekizumab 64, 160, or 320 mg for an additional 48 weeks (60 weeks in total). The primary objective was safety.
RESULTS


Across all dose groups (N = 217), initial PASI 90 responders generally maintained high levels of efficacy through week 60: PASI 90, 80% to 100%; 100% improvement in PASI, 69% to 83%; Investigator's Global Assessment score 0 or 1, 78% to 100% (all nonresponder imputation). Incidence of serious treatment-emergent adverse events was 15/217 (6.9%). No cases of inflammatory bowel disease, major adverse cardiovascular events, or suicidal ideation or behavior were reported.
LIMITATIONS


Low numbers in the bimekizumab 64 mg group (n = 15). The majority of 60-week data reported here are primarily for the week 12 PASI 90 responders only.
CONCLUSION


Bimekizumab response rates were maintained through week 60. A substantial proportion of patients achieved complete skin clearance. Bimekizumab was generally well tolerated.",2020,"Across all dose groups (N = 217), initial PASI90 responders generally maintained high levels of efficacy through week 60: PASI90, 80-100%; PASI100, 69-83%; Investigator's Global Assessment 0/1, 78-100% (all non-responder imputation).","['patients with moderate-to-severe plaque psoriasis', 'patients who had a Psoriasis Area and Severity Index (PASI) 90 response at week 12 received', 'patients with moderate-to-severe psoriasis (BE ABLE 2, NCT03010527']","['Bimekizumab', 'bimekizumab', 'PASI90', 'placebo']","['tolerated', 'complete skin clearance', 'safety', 'Bimekizumab response rates', 'Incidence of serious treatment-emergent adverse events', 'inflammatory bowel disease, MACE, or suicidal ideation/behavior']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]","[{'cui': 'C4519734', 'cui_str': 'bimekizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4519734', 'cui_str': 'bimekizumab'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.165099,"Across all dose groups (N = 217), initial PASI90 responders generally maintained high levels of efficacy through week 60: PASI90, 80-100%; PASI100, 69-83%; Investigator's Global Assessment 0/1, 78-100% (all non-responder imputation).","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, Oregon. Electronic address: ablauvelt@oregonmedicalresearch.com.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research and K. Papp Clinical Research, Waterloo, and University of Toronto, Toronto, Ontario.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Merola', 'Affiliation': ""Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Cross', 'Affiliation': 'UCB Biosciences Inc, Raleigh, North Carolina.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Madden', 'Affiliation': 'UCB Biosciences Inc, Raleigh, North Carolina.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'UCB Biosciences Inc, Raleigh, North Carolina.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cioffi', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Christopher E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'Salford Royal Hospital, University of Manchester, Manchester NIHR Biomedical Research Centre, Manchester, United Kingdom.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.05.105']
946,32482645,Tapering towards DMARD-free remission in established rheumatoid arthritis: 2-year results of the TARA trial.,"OBJECTIVES


To evaluate the 2-year clinical effectiveness of two gradual tapering strategies. The first strategy consisted of tapering the conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) first (i.e., methotrexate in ~90%), followed by the tumour necrosis factor inhibitor (TNF-inhibitor), the second strategy consisted of tapering the TNF-inhibitor first, followed by the csDMARD.
METHODS


This multicentre single-blinded randomised controlled trial included patients with rheumatoid arthritis (RA) with well-controlled disease for ≥3 consecutive months, defined as a Disease Activity Score (DAS) measured in 44 joints ≤2.4 and a swollen joint count ≤1, which was achieved with a csDMARD and a TNF-inhibitor. Eligible patients were randomised into gradual tapering the csDMARD followed by the TNF-inhibitor, or vice versa. The primary outcome was the number of disease flares. Secondary outcomes were DMARD-free remission (DFR), DAS, functional ability (Health Assessment Questionnaire Disability Index (HAQ-DI)) and radiographic progression.
RESULTS


189 patients were randomly assigned to tapering their csDMARD (n=94) or TNF-inhibitor (n=95) first. The cumulative flare rate after 24 months was, respectively, 61% (95% CI 50% to 71%) and 62% (95% CI 52% to 72%). The patients who tapered their csDMARD first were more often able to go through the entire tapering protocol and reached DFR more often than the group that tapered the TNF-inhibitor first (32% vs 20% (p=0.12) and 21% vs 10% (p=0.07), respectively). Mean DAS and HAQ-DI over time, and radiographic progression did not differ between groups (p=0.45, p=0.17, p=0.8, respectively).
CONCLUSION


The order of tapering did not affect flare rates, DAS or HAQ-DI. DFR was achievable in 15% of patients with established RA, slightly more frequent in patients that first tapered csDMARDs. Because of similar effects from a clinical viewpoint, financial arguments may influence the decision to taper TNF-inhibitors first.",2020,"Mean DAS and HAQ-DI over time, and radiographic progression did not differ between groups (p=0.45, p=0.17, p=0.8, respectively).
","['189 patients were randomly assigned to tapering their csDMARD (n=94) or', 'patients with rheumatoid arthritis (RA) with well-controlled disease for ≥3 consecutive months, defined as a Disease Activity Score (DAS) measured in 44 joints ≤2.4\u2009and a swollen joint count ≤1, which was achieved with a csDMARD and a TNF-inhibitor', 'Eligible patients']","['gradual tapering the csDMARD followed by the TNF-inhibitor, or vice versa', 'conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) first (i.e., methotrexate', 'TNF-inhibitor']","['DFR', 'flare rates, DAS or HAQ-DI', 'DMARD-free remission (DFR), DAS, functional ability (Health Assessment Questionnaire Disability Index (HAQ-DI)) and radiographic progression', 'cumulative flare rate', 'Mean DAS and HAQ-DI over time, and radiographic progression', 'number of disease flares']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}]","[{'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0102923', 'cui_str': 'ametantrone'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",189.0,0.0797802,"Mean DAS and HAQ-DI over time, and radiographic progression did not differ between groups (p=0.45, p=0.17, p=0.8, respectively).
","[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'van Mulligen', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands elise.vanmulligen@erasmusmc.nl.'}, {'ForeName': 'Angelique E', 'Initials': 'AE', 'LastName': 'Weel', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Hazes', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'van der Helm-van Mil', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Pascal Hendrik Pieter', 'Initials': 'PHP', 'LastName': 'de Jong', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217485']
947,32482095,Post-exercise provision of 40 g of protein during whole body resistance training further augments strength adaptations in elderly males.,"BACKGROUND


In the elderly, low protein intake exacerbates the effects of sarcopenia and anabolic resistance.  Protein supplementation to maximise muscle protein synthesis, may be an effective intervention. Aim: To determine the effects of a low/high dose of protein, ingested immediately post-exercise, during resistance training in novice elderly males. Method: 24 elderly (70.5±5.1, years) males were recruited (body mass: 92.4±14.9 kg; fat free mass: 61.4±7.6 kg).  After exclusion criteria, 18 males participated. Participants continued their normal dietary intake and were allocated into two matched groups, then randomly assigned to either a 20 g or 40 g dose intervention. Following determination of 1 repetition maximum (1RM), participants completed 10 x 3d -1  wk resistance training and consumed protein supplements immediately following exercise. Results: Significant improvements in chest press (p = 0.014, ɳp 2  0.34) shoulder press (p = 0.005, ɳp 2  0.43) and leg extension strength (p = 0.014, ɳp 2  0.34), were observed following the 40 g dose, resulting in performance improvements of 19.1, 21.1, and 16.1% respectively, compared to the 20 g dose. Conclusion:Findings suggest that ingesting 40 g of protein following resistance exercise, produces greater responses to training and may be an important nutritional strategy when prescribing resistance exercise in the elderly.",2020,"Significant improvements in chest press (p = 0.014, ɳp 2  0.34) shoulder press (p = 0.005, ɳp 2  0.43) and leg extension strength (p = 0.014, ɳp 2  0.34), were observed following the 40 g dose, resulting in performance improvements of 19.1, 21.1, and 16.1% respectively, compared to the 20 g dose. ","['novice elderly males', '24 elderly (70.5±5.1, years', 'elderly males', 'males were recruited (body mass: 92.4±14.9 kg; fat free mass: 61.4±7.6 kg', '18 males participated', 'Participants continued their normal dietary intake', 'participants completed 10 x 3d -1']","['wk resistance training and consumed protein supplements', 'Post-exercise provision of 40 g of protein during whole body resistance training', 'low/high dose of protein, ingested immediately post-exercise, during resistance training']","['leg extension strength', 'chest press']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205548', 'cui_str': 'Stat'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}]",18.0,0.0632351,"Significant improvements in chest press (p = 0.014, ɳp 2  0.34) shoulder press (p = 0.005, ɳp 2  0.43) and leg extension strength (p = 0.014, ɳp 2  0.34), were observed following the 40 g dose, resulting in performance improvements of 19.1, 21.1, and 16.1% respectively, compared to the 20 g dose. ","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Atherton', 'Affiliation': 'Department of Sport and Physical Activity, Edge Hill University, Sports Nutrition and Performance Research Group , Ormskirk, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Lars R', 'Initials': 'LR', 'LastName': 'McNaughton', 'Affiliation': 'Department of Sport and Physical Activity, Edge Hill University, Sports Nutrition and Performance Research Group , Ormskirk, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Graeme L', 'Initials': 'GL', 'LastName': 'Close', 'Affiliation': 'School of Sport and Exercise Sciences, Liverpool John Moores University , Liverpool, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Sparks', 'Affiliation': 'Department of Sport and Physical Activity, Edge Hill University, Sports Nutrition and Performance Research Group , Ormskirk, United Kingdom of Great Britain and Northern Ireland.'}]",Research in sports medicine (Print),['10.1080/15438627.2020.1770251']
948,32488988,"Authors' reply re: Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT).",,2020,,['women having repeat anterior or posterior prolapse surgery'],['mesh kit or native tissue repair'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",[],,0.201418,,"[{'ForeName': 'Cathryn Ma', 'Initials': 'CM', 'LastName': 'Glazener', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Breeman', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hagen', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Aucott', 'Affiliation': 'University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'Gynaecology, Aberdeen Royal Infirmary, Aberdeen, UK.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Reid', 'Affiliation': ""St Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.""}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16302']
949,32488989,Phase 1 Study to Evaluate the Effect of the Investigational Anticancer Agent Sapanisertib on the QTc Interval in Patients With Advanced Solid Tumors.,"The aim of this phase 1 study was to determine the effects of sapanisertib on the heart rate-corrected QT (QTc) interval in patients with advanced solid tumors. Adult patients with advanced solid tumors were enrolled to receive a single sapanisertib 40-mg dose. Blood samples for pharmacokinetic analysis were collected and electrocardiogram readings were recorded at baseline and up to 48 hours after dosing. Patients could continue to receive sapanisertib 30 mg once weekly in 28-day cycles for up to 12 months. The primary objective was to characterize the effect of a single dose of sapanisertib (40 mg) on the QT interval. Secondary objectives were to evaluate safety, tolerability, and pharmacokinetics. Following a single sapanisertib 40-mg dose in 44 patients, the maximum least squares mean (upper bound of 1-sided 95% confidence interval) changes from time-matched baseline were 7.1 milliseconds (11.4 milliseconds) for individual rate-corrected QT interval at 24 hours after dosing, and 1.8 milliseconds (5.6 milliseconds) for Fridericia-corrected QTc at 1 hour post-dose. There was no sapanisertib plasma concentration-dependent increase in the change from time-matched baseline individual rate-corrected QTc interval or Fridericia-corrected QTc. The most common adverse events following sapanisertib 30 mg once-weekly dosing were nausea (80%), fatigue (61%), vomiting (57%), and decreased appetite (45%). A single sapanisertib 40 mg dose did not produce clinically relevant effects on QTc interval in patients with advanced solid tumors. The safety profile of sapanisertib 30 mg once weekly was favorable, and no new safety signals were observed (NCT02197572, clinicaltrials.gov).",2020,A single sapanisertib 40 mg dose did not produce clinically relevant effects on QTc interval in patients with advanced solid tumors.,"['Adult patients with advanced solid tumors', 'Patients With Advanced Solid Tumors', 'patients with advanced solid tumors']",['sapanisertib'],"['QTc interval', 'fatigue', 'safety, tolerability, and pharmacokinetics', 'sapanisertib plasma concentration', 'appetite', 'vomiting', 'nausea', 'heart rate-corrected QT (QTc) interval']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]",[],"[{'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",,0.278022,A single sapanisertib 40 mg dose did not produce clinically relevant effects on QTc interval in patients with advanced solid tumors.,"[{'ForeName': 'Chirag', 'Initials': 'C', 'LastName': 'Patel', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Goel', 'Affiliation': 'Montefiore Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Manish R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, Florida, USA.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Rangachari', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Jayson D', 'Initials': 'JD', 'LastName': 'Wilbur', 'Affiliation': 'Metrum Research Group, LCC, Connecticut, USA.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Shou', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Venkatakrishnan', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'A Craig', 'Initials': 'AC', 'LastName': 'Lockhart', 'Affiliation': 'Sylvester Comprehensive Cancer Center, Miller School of Medicine, University of Miami, Miami, Florida, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.808']
950,32581313,Effect of an antioxidant supplement containing high dose lutein and zeaxanthin on macular pigment and skin carotenoid levels.,"The effect of a high dose lutein/zeaxanthin supplement on macular pigment optical density (MPOD) and skin carotenoid (SC) levels in healthy subjects was investigated. This is a prospective, single-arm, open-label study. Subjects were 16 Japanese, age 26-57 years. Subjects took a supplement containing 20 mg/day of lutein, 4 mg/day of zeaxanthin, and other antioxidants (vitamin C, vitamin E, zinc, copper) for 16 weeks. MPOD levels were measured by a two-wavelength autofluorescence imaging technique. SC levels were measured by reflection spectroscopy. Total volume of MPOD within 9° eccentricity significantly increased by week 8 and continued to increase until week 16 (p < 0.0001, two-way factorial ANOVA). The increase rate of MPOD was significantly higher in subjects with body mass index (BMI) less than 25 kg/m 2  (n = 13) compared to those of 25 kg/m 2  and higher (n = 3). SC levels increased significantly by week 4 and continued to increase until week 16 (p < 0.0001, two-way factorial ANOVA). All subjects completed the study without any serious adverse events. These results demonstrated the effectiveness of a high dose lutein/zeaxanthin supplement for MPOD volume and SC levels without serious adverse events.",2020,The increase rate of MPOD was significantly higher in subjects with body mass index,"['subjects with body mass index', 'healthy subjects', 'Subjects were 16 Japanese, age 26-57 years']","['lutein/zeaxanthin supplement', 'antioxidant supplement containing high dose lutein and zeaxanthin', 'supplement containing 20\u2009mg/day of lutein, 4\u2009mg/day of zeaxanthin, and other antioxidants (vitamin C, vitamin E, zinc, copper', 'lutein/zeaxanthin']","['macular pigment and skin carotenoid levels', 'rate of MPOD', 'macular pigment optical density (MPOD) and skin carotenoid (SC) levels', 'SC levels', 'Total volume of MPOD within 9° eccentricity', 'MPOD levels', 'MPOD volume and SC levels']","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2929534', 'cui_str': 'Lutein / zeaxanthin'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0009968', 'cui_str': 'Copper'}]","[{'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0233047,The increase rate of MPOD was significantly higher in subjects with body mass index,"[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Obana', 'Affiliation': 'Department of Ophthalmology, Seirei Hamamatsu General Hospital, Hamamatsu, Shizuoka, Japan. obana@sis.seirei.or.jp.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Gohto', 'Affiliation': 'Department of Ophthalmology, Seirei Hamamatsu General Hospital, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Nakazawa', 'Affiliation': 'Department of Ophthalmology, Seirei Hamamatsu General Hospital, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Moriyama', 'Affiliation': 'Department of Ophthalmology, Seirei Hamamatsu General Hospital, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Gellermann', 'Affiliation': 'Longevity Link Corporation, Salt Lake City, UT, United States of America.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Bernstein', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Moran Eye Center, University of Utah School of Medicine, Salt Lake City, Utah, United States of America.'}]",Scientific reports,['10.1038/s41598-020-66962-2']
951,32586176,"Re: Health Care Hotspotting-A Randomized, Controlled Trial.",,2020,,[],[],[],[],[],[],,0.217515,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Resnick', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001171.02']
952,32586177,Re: Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression among Men with Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial.,,2020,,['Men with Early-Stage Prostate Cancer'],['Behavioral Intervention to Increase Vegetable Consumption'],['Cancer Progression'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0178874', 'cui_str': 'Tumor progression'}]",,0.0490649,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Resnick', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001171']
953,32586190,"Re: The Daily Therapy with L-Arginine 2,500 mg and Tadalafil 5 mg in Combination and in Monotherapy for the Treatment of Erectile Dysfunction: A Prospective, Randomized Multicentre Study.",,2020,,['Erectile Dysfunction'],"['L-Arginine 2,500 mg and Tadalafil 5 mg in Combination and in Monotherapy']",[],"[{'cui': 'C0242350', 'cui_str': 'Impotence'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C1331168', 'cui_str': 'tadalafil 5 MG'}]",[],,0.018511,,"[{'ForeName': 'Allen D', 'Initials': 'AD', 'LastName': 'Seftel', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001167.03']
954,32588971,A randomized controlled trial of amyloid positron emission tomography results disclosure in mild cognitive impairment.,"INTRODUCTION


Recent studies suggest that Alzheimer's disease (AD) biomarker disclosure has no discernable psychological impact on cognitively healthy persons. Far less is known about how such results affect symptomatic individuals and their caregivers.
METHODS


Randomized controlled trial of 82 mild cognitive impairment (MCI) patient and caregiver dyads (total n = 164) to determine the effect of receiving amyloid positron emission tomography results on understanding of, and perceived efficacy to cope with, MCI over 52 weeks of follow-up.
RESULTS


Gains in the primary outcomes were not consistently observed. Amyloid negative patients reported greater perceived ambiguity regarding MCI at follow-up, while moderate and sustained emotional distress was observed in patients, and to a lesser extent, caregivers, of those who were amyloid positive. There was no corresponding increase in depressive symptoms.
DISCUSSION


These findings point to the possibility that both MCI patients and caregivers may need emotional support after the disclosure of amyloid scan results.",2020,"Amyloid negative patients reported greater perceived ambiguity regarding MCI at follow-up, while moderate and sustained emotional distress was observed in patients, and to a lesser extent, caregivers, of those who were amyloid positive.","['mild cognitive impairment', '82 mild cognitive impairment (MCI) patient and caregiver dyads (total n = 164', 'cognitively healthy persons']",['amyloid positron emission tomography'],"['sustained emotional distress', 'depressive symptoms']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",82.0,0.143392,"Amyloid negative patients reported greater perceived ambiguity regarding MCI at follow-up, while moderate and sustained emotional distress was observed in patients, and to a lesser extent, caregivers, of those who were amyloid positive.","[{'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Lingler', 'Affiliation': 'Department of Health and Community Systems, School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'Department of Health and Community Systems, School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Meryl A', 'Initials': 'MA', 'LastName': 'Butters', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Ann D', 'Initials': 'AD', 'LastName': 'Cohen', 'Affiliation': ""Alzheimer's Disease Research Center, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Klunk', 'Affiliation': ""Alzheimer's Disease Research Center, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Knox', 'Affiliation': 'Department of Health and Community Systems, School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'McDade', 'Affiliation': 'Department of Neurology, School of Medicine, Washington University, St. Louis, Missouri, USA.'}, {'ForeName': 'Neelesh K', 'Initials': 'NK', 'LastName': 'Nadkarni', 'Affiliation': ""Alzheimer's Disease Research Center, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Roberts', 'Affiliation': 'University of Michigan School of Public Health, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Tamres', 'Affiliation': 'Department of Health and Community Systems, School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Oscar L', 'Initials': 'OL', 'LastName': 'Lopez', 'Affiliation': ""Alzheimer's Disease Research Center, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1002/alz.12129']
955,32590482,Comparative study of topical steroids vs nonsteroidal anti-inflammatory drugs to control postcataract surgery inflammation.,"PURPOSE


To evaluate the efficacy of bromfenac ophthalmic solution 0.09% in comparison with topical steroids after phacoemulsification cataract surgery, while specifically looking at differences in visual acuities, anterior chamber reaction, and central retinal thickness changes.
SETTING


Mission Nethralaya, India.
DESIGN


Prospective, randomized, investigator-masked, comparative clinical trial.
METHODS


Patients were randomly assigned to 3 treatment groups: In group I, bromfenac was prescribed 3 times a day for 1 month; in group II, prednisolone acetate 1% eye suspension was prescribed 4 times a day for 1 month; and in group III, prednisolone acetate 1% was prescribed 4 times a day for 2 weeks and bromfenac 2 times a day for 1 month. All patients received anti-infective preoperative and postoperative standards of care. Study visit assessments included corrected distance visual acuity, biomicroscopy, intraocular pressure, adverse events, and concomitant medication review. Optical coherence tomography was performed on postoperative days 7, 21, and 60.
RESULTS


Each group included 150 eyes. All treatment groups had similar baseline measurements. There was a significant difference in anterior chamber reaction observed between group I and group II (P < .001) and group I and group III (P < .001) on postoperative days 1 and 7. On postoperative day 21, thickening of the central fovea was observed in group II as compared with group I and group III. This difference was statistically significant (P < .001).
CONCLUSIONS


The combination of topical nonsteroidal anti-inflammatory drugs and topical steroids resulted in positive clinical outcomes after cataract surgery.",2020,There was a significant difference in anterior chamber reaction observed between Group I and Group II (P < 0.001) and Group I and Group III (P < 0.001) on postoperative days 1 and 7.,"['cataract surgery', 'control post-cataract surgery inflammation', 'Patients', 'Mission Nethralaya, India']","['Optical coherence tomography', 'topical steroids', 'bromfenac ophthalmic solution', 'prednisolone acetate', 'topical NSAIDs and topical steroids', 'topical steroids vs nonsteroidal anti-inflammatory drugs', 'prednisolone acetate 1% eye suspension']","['corrected distance visual acuity, biomicroscopy, intraocular pressure, adverse events, and concomitant medication review', 'anterior chamber reaction', 'positive clinical outcomes', 'thickening of the central fovea', 'visual acuities, anterior chamber reaction, and central retinal thickness changes']","[{'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026219', 'cui_str': 'Missions'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C1618765', 'cui_str': 'bromfenac Ophthalmic Solution'}, {'cui': 'C0071839', 'cui_str': 'Prednisolone acetate'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0991532', 'cui_str': 'Eye suspension'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016622', 'cui_str': 'Structure of fovea centralis'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",150.0,0.0427647,There was a significant difference in anterior chamber reaction observed between Group I and Group II (P < 0.001) and Group I and Group III (P < 0.001) on postoperative days 1 and 7.,"[{'ForeName': 'Amarendra', 'Initials': 'A', 'LastName': 'Deka', 'Affiliation': 'From the Mission Nethralaya, Shillong, India.'}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000291']
956,32591562,"Effect of palmitoylethanolamide on inner retinal function in glaucoma: a randomized, single blind, crossover, clinical trial by pattern-electroretinogram.","Glaucoma is a neurodegenerative disease, our study aimed to evaluate the potential effects of Palmitoylethanolamide (PEA) supplementation on RGCs function by PERG examination, and to record effects on intraocular pressure, visual field and quality of life. It was a single centre, randomized, prospective, single blind, two treatment, two period crossover study on stable glaucoma patients on topical monotherapy comparing current topical therapy alone or additioned with PEA 600 mg one tablet a day. At baseline, at 4 and at 8 months, all patients underwent to complete ophthalmic examination, pattern electroretinogram, visual field, and quality of life evaluation. 40 patients completed the study: mean age 66.6 ± 7.6 years; 21 (52.5%) male; 35 POAG (87.5%). At baseline, most patients had an early visual field defect, the IOP was well controlled. At the end of the PEA 600 mg supplementation, a significantly higher (mean 0.56 μV, 95% CI 0.30-0.73, p < 0.001) in the P50-wave amplitude was observed; in the PEA period a significantly lower IOP (- 1.6 mmHg, 95% CI - 2 to 1.2, p < 0.001) and higher quality of life scores (+ 6.7, 95% CI 4-9.9, p < 0.001) were observed. Our study is the first to show promising effects of PEA on PERG and on quality of life in glaucoma patients.",2020,"At the end of the PEA 600 mg supplementation, a significantly higher (mean 0.56 μV, 95% CI 0.30-0.73, p < 0.001) in the P50-wave amplitude was observed; in the PEA period a significantly lower IOP (- 1.6 mmHg, 95% CI - 2 to 1.2, p < 0.001) and higher quality of life scores (+ 6.7, 95% CI 4-9.9, p < 0.001) were observed.","['40 patients completed the study: mean age 66.6\u2009±\u20097.6\xa0years; 21 (52.5%) male; 35 POAG (87.5', 'stable glaucoma patients on topical monotherapy comparing current', 'glaucoma', 'glaucoma patients']","['PEA', 'topical therapy alone or additioned with PEA 600\xa0mg one tablet a day', 'palmitoylethanolamide', 'Palmitoylethanolamide (PEA) supplementation']","['quality of life', 'higher quality of life scores', 'IOP', 'complete ophthalmic examination, pattern electroretinogram, visual field, and quality of life evaluation', 'intraocular pressure, visual field and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517802', 'cui_str': '52.5'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C4517896', 'cui_str': '87.5'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0069964', 'cui_str': 'palmidrol'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",,0.275603,"At the end of the PEA 600 mg supplementation, a significantly higher (mean 0.56 μV, 95% CI 0.30-0.73, p < 0.001) in the P50-wave amplitude was observed; in the PEA period a significantly lower IOP (- 1.6 mmHg, 95% CI - 2 to 1.2, p < 0.001) and higher quality of life scores (+ 6.7, 95% CI 4-9.9, p < 0.001) were observed.","[{'ForeName': 'Gemma Caterina Maria', 'Initials': 'GCM', 'LastName': 'Rossi', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy. gemma.rossi.md@gmail.com.'}, {'ForeName': 'Luigia', 'Initials': 'L', 'LastName': 'Scudeller', 'Affiliation': 'Clinical Epidemiology and Biometric Unit, Scientific Direction, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Lumini', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Bettio', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Picasso', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Ruberto', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Aba', 'Initials': 'A', 'LastName': 'Briola', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Mirabile', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Paviglianiti', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Gian Maria', 'Initials': 'GM', 'LastName': 'Pasinetti', 'Affiliation': 'Eye Unit, Istituto Beato Palazzolo, Bergamo, Italy.'}, {'ForeName': 'Paolo Emilio', 'Initials': 'PE', 'LastName': 'Bianchi', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}]",Scientific reports,['10.1038/s41598-020-67527-z']
957,32600489,Volunteers' experiences of providing telephone-based breast-feeding peer support in the RUBY randomised controlled trial.,"OBJECTIVE


The Ringing Up About Breastfeeding earlY (RUBY) randomised controlled trial (RCT) found that a telephone-based peer volunteer support intervention increased breast-feeding duration in a setting with high breast-feeding initiation. This sub-study of the RUBY RCT describes the motivation, preparation and experiences of volunteers who provided the peer support intervention.
DESIGN


An online survey was completed by 154 (67 %) volunteers after ceasing volunteering.
SETTING


Volunteers provided peer support to primiparous women (n 574) who birthed at one of three public hospitals in Melbourne, Australia, between February 2013 and December 2015.
PARTICIPANTS


Volunteers (n 230) had themselves breastfed for at least 6 months and received 4 h of training for the role.
RESULTS


The median number of mothers supported was two (range 1-11), and two-thirds of respondents supported at least one mother for 6 months. Volunteers were motivated by a strong desire to support new mothers to establish and continue breast-feeding. Most (93 %) considered the training session adequate. The majority (60 %) reported following the call schedule 'most of the time', but many commented that 'it depends on the mother'. Overall, 84 % of volunteers were satisfied with the role and reported that the experience was enjoyable (85 %) and worthwhile (90 %). Volunteers agreed that telephone support for breast-feeding was valued by women (88 %) and that the programme would be effective in helping women to breastfeed (93 %).
CONCLUSIONS


These findings are important for those developing similar peer support programmes in which recruiting volunteers and developing training requirements are an integral and recurrent part of volunteer management.",2020,found that a telephone-based peer volunteer support intervention increased breast-feeding duration in a setting with high breast-feeding initiation.,"['Volunteers provided peer support to primiparous women (n 574) who birthed at one of three public hospitals in Melbourne, Australia, between February 2013 and December 2015', 'Volunteers (n 230) had themselves breastfed for at least 6 months and received 4 h of training for the role']","['RUBY RCT', 'telephone-based breast-feeding peer support', 'telephone-based peer volunteer support intervention', 'Ringing Up']","['breast-feeding duration', 'median number of mothers']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0035820', 'cui_str': 'Role'}]","[{'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",,0.031904,found that a telephone-based peer volunteer support intervention increased breast-feeding duration in a setting with high breast-feeding initiation.,"[{'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Grimes', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Melbourne, Victoria3000, Australia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Shafiei', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Melbourne, Victoria3000, Australia.'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'McLachlan', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Melbourne, Victoria3000, Australia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Forster', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Melbourne, Victoria3000, Australia.'}]",Public health nutrition,['10.1017/S136898002000124X']
958,32607949,The efficacy and mechanism for action of iguratimod in primary Sjögren's syndrome patients.,"PURPOSE


Primary Sjögren's syndrome (pSS) has been proven as a systemic autoimmune disorder (such as Sjogren's syndrome dry eye). This research aimed to evaluate potential treating effects of Iguratimod on pSS.
METHODS


Fifty pSS patients were enrolled and randomly divided into Conventional group and Iguratimod group. Improvement in pSS was evaluated every 4 weeks. pSS disease activity was evaluated with European League Against Rheumatism (EULAR) Sjögren's syndrome disease activity index (ESSDAI). Symptoms were evaluated by determining EULAR Sjögren's syndrome patient-reported index (ESSPRI), platelet (PLT), IgG and Schirmer I test. Peripheral blood B cell molecules (CD135, IgD, CD38, CD20) and human B cell-activating factor-receptor (BAFF-R) were analyzed with flow cytometry.
RESULTS


After treating for 12-weeks, pSS patients in Iguratimod and Conventional group showed a significant decrease in disease activity (ESSPRI, ESSDAI, PLT, IgG and Schirmer I test) comparing with baselines. Patients' ESSPRI (2.92 ± 0.19) and disease activity of ESSDAI (4.32 ± 0.29), PLT (95.64 ± 1.86), IgG (13.0 ± 0.45) and Schirmer I test (4.67 ± 0.31) in Iguratimod group were significantly lower compared to Conventional group (4.64 ± 0.15, 5.8 ± 2.08, 77.44 ± 1.41, 16.5 ± 0.44 and 2.25 ± 0.11) (p < 0.0001). Changes of ESSPRI, ESSDAI, PLT, IgG and Schirmer I test were remarkable observed between two groups (p < 0.001). Iguratimod and Conventional treatment demonstrated a significant reduction in total B cells in pSS patients compared with pre-treatment. The pSS patients from Iguratimod and Conventional group showed a significant decreased BAFF-R (61.82 ± 1.52, 74.07 ± 1.11) and CD38 + IgD +  (48.08 ± 0.92, 62.66 ± 1.12) on B cells after treatment compared with baseline (92.26 ± 0.32, 91.53 ± 0.45, 84.39 ± 0.59, 85.04 ± 0.46) (p < 0.001). After treating 12 weeks, BAFF-R, CD38 + IgD +  expression in Iguratimod group decreased significantly compared to Conventional group (p < 0.001).
CONCLUSIONS


Iguratimod alleviated symptoms and mediated adaptive-immunity balance by suppressing BAFF-R positive B cell in pSS patients.",2020,Iguratimod and Conventional treatment demonstrated a significant reduction in total B cells in pSS patients compared with pre-treatment.,"['pSS patients', ""Primary Sjögren's syndrome (pSS"", 'Fifty pSS patients', ""primary Sjögren's syndrome patients""]","['Conventional group and Iguratimod group', 'pSS']","['disease activity', ""Sjögren's syndrome disease activity index (ESSDAI"", 'disease activity of ESSDAI', 'total B cells', 'BAFF-R, CD38 + IgD +  expression', ""EULAR Sjögren's syndrome patient-reported index (ESSPRI), platelet (PLT), IgG and Schirmer"", 'Peripheral blood B cell molecules (CD135, IgD, CD38, CD20) and human B cell-activating factor-receptor (BAFF-R', 'disease activity (ESSPRI, ESSDAI, PLT, IgG and Schirmer', 'BAFF-R', 'European League Against Rheumatism (EULAR', 'Changes of ESSPRI, ESSDAI, PLT, IgG and Schirmer']","[{'cui': 'C0151449', 'cui_str': ""Primary Sjögren's syndrome""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1872427', 'cui_str': 'iguratimod'}, {'cui': 'C0151449', 'cui_str': ""Primary Sjögren's syndrome""}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1527336', 'cui_str': ""Sjögren's syndrome""}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C1384654', 'cui_str': 'TNFRSF13C protein, human'}, {'cui': 'C0075742', 'cui_str': 'Lymphocyte antigen CD38'}, {'cui': 'C0020843', 'cui_str': 'Immunoglobulin D'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0054946', 'cui_str': 'Lymphocyte antigen CD20'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",50.0,0.0365604,Iguratimod and Conventional treatment demonstrated a significant reduction in total B cells in pSS patients compared with pre-treatment.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': ""Department of Integrated Traditional Chinese and Western Medicine, The Ninth People's Hospital of Chongqing, Chongqing, China.""}, {'ForeName': 'Lingshu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology and Immunology, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Wuhou District, Chengdu, 610041, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Rheumatology and Immunology, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Wuhou District, Chengdu, 610041, China.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ""Department of Integrated Traditional Chinese and Western Medicine, The Ninth People's Hospital of Chongqing, Chongqing, China.""}, {'ForeName': 'Chunrong', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': ""Department of Integrated Traditional Chinese and Western Medicine, The Ninth People's Hospital of Chongqing, Chongqing, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology and Immunology, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Wuhou District, Chengdu, 610041, China. Liuyi2020huaxi@163.com.'}]",International ophthalmology,['10.1007/s10792-020-01490-6']
959,32612104,Evaluation of enhanced recovery after surgery program components implemented in laparoscopic appendectomy: prospective randomized clinical study.,"BACKGROUND


Laparoscopic appendectomy (LA) is a widely used surgical procedure. Patients often suffer from considerable postoperative pain and indigestion, which prolongs their in-hospital stay. Almost 10% of patients develop postoperative complications. The enhanced recovery after surgery (ERAS) program has proven its efficacy in elective surgery and could hypothetically improve LA outcomes. Currently, there is no ERAS program for LA.
METHODS


A modified ERAS (mERAS) protocol was studied in a prospective, randomized nonblinded clinical trial. The mERAS group consisted of 50 patients; the control group, of 54 patients. The mERAS protocol included a patient information brochure; minimizing drain use; local anesthesia; low-pressure pneumoperitoneum; early mobilization and oral diet. The primary outcome was postoperative length of stay (pLOS).
RESULTS


Modified protocol reduced median pLOS to 1.25 days vs 2 days in the controls (p < 0.0001). Twenty-one (42%) mERAS patients and 4 (7.4%) controls were discharged within 24 h (p < 0.001) after surgery; 0 readmissions were reported. Postoperative pain intensity assessed on the visual analogue scale was significantly lower in the mERAS group [mERAS vs control 0 h, 2 h, 6 h, 12 h and 24 h after surgery: 2.33 ± 2.12 vs 4.19 ± 2.08 (p < 0.0001), 2.27 ± 1.91 vs 4.02 ± 1.89 (p < 0.0001), 2.28 ± 1.98 vs 3.70 ± 1.57 (p = 0.0001), 1.98 ± 1.72 vs 3.43 ± 1.54 (p < 0.0001) and 1.80 ± 1.74 vs 3.00 ± 1.27 (p = 0.032), respectively)]. The severity of shoulder and neck pain was lower but its incidence was similar. Peristalsis recovery was achieved earlier in the study group (median (min-max))-mERAS 7 (2-34) h vs control 11 (3-43) h; p = 0.009) but did not affect the time of the first flatus 23 (2-72) h vs 29 (6-70) h, respectively; p = 0.499).
CONCLUSIONS


The modified ERAS program for LA has advantages over the traditional approach.
REGISTRATION


This trial was registered at ClinicalTrials.gov as NCT03754777 (27/11/2018).",2020,Postoperative pain intensity assessed on the visual analogue scale was significantly lower in the mERAS group [mERAS vs control 0 ,['laparoscopic appendectomy'],"['patient information brochure; minimizing drain use; local anesthesia; low-pressure pneumoperitoneum; early mobilization and oral diet', 'Laparoscopic appendectomy (LA']","['Peristalsis recovery', 'postoperative length of stay (pLOS', 'postoperative complications', 'Postoperative pain intensity assessed on the visual analogue scale', 'severity of shoulder and neck pain', 'postoperative pain and indigestion', 'median pLOS']","[{'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}]","[{'cui': 'C0031133', 'cui_str': 'Peristalsis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.166543,Postoperative pain intensity assessed on the visual analogue scale was significantly lower in the mERAS group [mERAS vs control 0 ,"[{'ForeName': 'Taras', 'Initials': 'T', 'LastName': 'Nechay', 'Affiliation': 'Pirogov Russian National Research Medical University, State Clinical Hospital #1, Moscow, Russia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sazhin', 'Affiliation': 'Pirogov Russian National Research Medical University, State Clinical Hospital #1, Moscow, Russia.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Titkova', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Tyagunov', 'Affiliation': 'Pirogov Russian National Research Medical University, State Clinical Hospital #1, Moscow, Russia.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Anurov', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'Kirill', 'Initials': 'K', 'LastName': 'Melnikov-Makarchuk', 'Affiliation': 'Pirogov Russian National Research Medical University, State Clinical Hospital Named After V.M. Buyanov, Moscow, Russia. worker.gq@yandex.ru.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Tyagunov', 'Affiliation': 'Pirogov Russian National Research Medical University, State Clinical Hospital Named After V.M. Buyanov, Moscow, Russia.'}]",Scientific reports,['10.1038/s41598-020-67591-5']
960,32612186,"Avocado (Persea americana) pulp improves cardiovascular and autonomic recovery following submaximal running: a crossover, randomized, double-blind and placebo-controlled trial.","Previous studies have demonstrated that regular avocado consumption presents advantageous effects on cardiovascular system. However, little attention has been paid to the use of avocado as a dietary supplement, in particular, for individuals involved in physical exercise training. Therefore, this study aims to evaluate the effect of acute avocado pulp intake on cardiovascular and autonomic recovery subsequent to moderate exercise. Using a crossover, randomized, double-blind and placebo-controlled trial design, 16 healthy female adults underwent two protocols: Avocado pulp (600 mg in capsule) and placebo (600 mg starch in capsule). After the ingestion of Avocado pulp or placebo, the subjects were seated for 60 min at rest, followed by running on a treadmill at a submaximal level and then remained seated for 60 min during recovery from the exercise. Heart rate (HR), heart rate variability (HRV) [rMSSD, SD1, HF (ms 2 )] and skin conductance were evaluated before and during exercise, as well as during recovery. HR, systolic blood pressure, HRV and skin conductance recovered faster when subjects were given avocado pulp prior to exercise. In conclusion, avocado pulp improved cardiovascular and autonomic recovery after exercise, suggesting a reduced risk of cardiovascular events after exertion. The current results support the beneficial effects of ingestion of avocado prior to submaximal treadmill running.",2020,"HR, systolic blood pressure, HRV and skin conductance recovered faster when subjects were given avocado pulp prior to exercise.",['16 healthy female adults underwent two protocols'],"['placebo', 'Avocado pulp or placebo', 'Avocado pulp (600\xa0mg in capsule) and placebo', 'Avocado (Persea americana) pulp', 'acute avocado pulp intake']","['HR, systolic blood pressure, HRV and skin conductance', 'Heart rate (HR), heart rate variability (HRV) [rMSSD, SD1, HF (ms 2 )] and skin conductance', 'risk of cardiovascular events', 'cardiovascular and autonomic recovery']","[{'cui': 'C0686752', 'cui_str': 'Well female adult'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0330230', 'cui_str': 'Avocado'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0949120', 'cui_str': 'Persea americana'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1861380', 'cui_str': 'Syndactyly, Type I'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}]",16.0,0.480823,"HR, systolic blood pressure, HRV and skin conductance recovered faster when subjects were given avocado pulp prior to exercise.","[{'ForeName': 'Fernando H', 'Initials': 'FH', 'LastName': 'Sousa', 'Affiliation': 'Department of Morphology and Physiology, University Health Center ABC, Santo Andre, SP, Brazil.'}, {'ForeName': 'Vitor E', 'Initials': 'VE', 'LastName': 'Valenti', 'Affiliation': 'Autonomic Nervous System Center (CESNA), Sao Paulo State University (UNESP), Av. Hygino Muzzi Filho, 737, Mirante, 17, Marilia, SP, 525-900, Brazil. vitor.valenti@marilia.unesp.br.'}, {'ForeName': 'Leticia C', 'Initials': 'LC', 'LastName': 'Pereira', 'Affiliation': 'Autonomic Nervous System Center (CESNA), Sao Paulo State University (UNESP), Av. Hygino Muzzi Filho, 737, Mirante, 17, Marilia, SP, 525-900, Brazil.'}, {'ForeName': 'Rafaela R', 'Initials': 'RR', 'LastName': 'Bueno', 'Affiliation': 'Autonomic Nervous System Center (CESNA), Sao Paulo State University (UNESP), Av. Hygino Muzzi Filho, 737, Mirante, 17, Marilia, SP, 525-900, Brazil.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Prates', 'Affiliation': 'Autonomic Nervous System Center (CESNA), Sao Paulo State University (UNESP), Av. Hygino Muzzi Filho, 737, Mirante, 17, Marilia, SP, 525-900, Brazil.'}, {'ForeName': 'Amanda N', 'Initials': 'AN', 'LastName': 'Akimoto', 'Affiliation': 'Post-Graduate Program in Physical Therapy, Sao Paulo State University (UNESP), Presidente Prudente, SP, Brazil.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Kaviani', 'Affiliation': 'Autonomic Nervous System Center (CESNA), Sao Paulo State University (UNESP), Av. Hygino Muzzi Filho, 737, Mirante, 17, Marilia, SP, 525-900, Brazil.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Garner', 'Affiliation': 'Autonomic Nervous System Center (CESNA), Sao Paulo State University (UNESP), Av. Hygino Muzzi Filho, 737, Mirante, 17, Marilia, SP, 525-900, Brazil.'}, {'ForeName': 'Joice A T', 'Initials': 'JAT', 'LastName': 'Amaral', 'Affiliation': 'Department of Pediatric, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luiz Carlos', 'Initials': 'LC', 'LastName': 'de Abreu', 'Affiliation': 'Department of Morphology and Physiology, University Health Center ABC, Santo Andre, SP, Brazil.'}]",Scientific reports,['10.1038/s41598-020-67577-3']
961,32614482,A brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating: a feasibility study.,"AIM


To examine the feasibility and acceptability of a brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating behaviour.
METHODS


Twenty-seven adolescents with type 1 diabetes were recruited and randomized to receive the brief (two 2.5-h sessions) self-compassion intervention, either in the intervention group (n=11) or in a waitlist control group (n=8). The intervention was adapted from the standardized eight-session 'Making Friends with Yourself' programme, and sessions were delivered 1 week apart. Acceptability was assessed through qualitative questionnaires and feasibility was assessed based on session attendance and recruitment metrics. Possible changes to disordered eating behaviour, self-care behaviours, diabetes-related distress, self-compassion, stress and glycaemic control were also assessed.
RESULTS


Nineteen participants completed the study, and they reported an increased sense of common humanity (acknowledging that we are not alone), mindfulness, and coping resources. In terms of feasibility, recruitment took longer than expected (8 months) and not all participants were able to attend both sessions (nine could only attend one of the two sessions).
CONCLUSIONS


While self-compassion is a strong conceptual fit for the issues of type 1 diabetes and disordered eating behaviour in adolescence, and the intervention content appears acceptable, feasibility issues were such that brief self-compassion programmes will probably need to be adapted into digital interventions for future research. (Trial registration number: ANZCTR 12619000541101).",2020,"Possible changes to disordered eating behaviour, self-care behaviours, diabetes-related distress, self-compassion, stress and glycaemic control were also assessed.
","['Twenty-seven adolescents with type 1 diabetes', 'adolescents with type 1 diabetes and disordered eating', 'adolescents with type 1 diabetes and disordered eating behaviour', 'Nineteen participants']","['brief self-compassion intervention', 'self-compassion intervention']","['feasibility and acceptability', 'disordered eating behaviour, self-care behaviours, diabetes-related distress, self-compassion, stress and glycaemic control', 'Acceptability']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",27.0,0.0257097,"Possible changes to disordered eating behaviour, self-care behaviours, diabetes-related distress, self-compassion, stress and glycaemic control were also assessed.
","[{'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Boggiss', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Consedine', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Schache', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jefferies', 'Affiliation': ""Starship Children's Health, Auckland City Hospital, Auckland, New Zealand.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bluth', 'Affiliation': 'Department of Psychiatry, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Hofman', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Serlachius', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14352']
962,32609465,Neck-Related Headache in Patients With Cervical Disc Disease After Surgery and Physiotherapy: A 1-Year Follow-up of a Prospective Randomized Study.,"STUDY DESIGN


A prospective randomized multicenter trial.
OBJECTIVE


To investigate the effects of surgery with either structured postoperative physiotherapy or standard postoperative approach on neck-related headache in patients with cervical radiculopathy. Secondary, to investigate associations between change in neck-related headache and change in neck muscle endurance, neck mobility, or neck pain.
SUMMARY OF BACKGROUND DATA


The effect of physiotherapy on individuals with neck-related headache after surgery for cervical radiculopathy due to magnetic resonance imaging-verified disc disease is unknown.
METHODS


One hundred six patients with neck-related headache and participating in a randomized controlled trial evaluating the additional effects of physiotherapy after surgery for cervical radiculopathy were included. Patients were randomized preoperatively to structured postoperative physiotherapy (n = 51) or the standard postoperative approach (n = 55). Outcome measures were headache intensity and neck pain intensity, neck muscle endurance, and neck mobility. Measures were obtained preoperatively and at 6 weeks, 3 months, 6 months, and 1 year postoperatively.
RESULTS


Headache intensity significantly changed from baseline to 1 year postoperatively (P < 0.001) in both groups. Post-hoc tests showed a significant difference between baseline and 6 weeks (P ≤ 0.05). No significant differences were found between groups (P > 0.05) or between-group differences in changes over time (P > 0.05). The change in current headache intensity over time was associated with a change in current neck pain intensity over time (P = 0.003, β = 0.40).
CONCLUSION


There was a significant improvement in headache intensity 1 year postoperatively in patients with cervical radiculopathy and neck-related headache, but there were no differences between groups over time. Change in current headache intensity was only associated with a change in current neck pain intensity.
LEVEL OF EVIDENCE


2.",2020,"There was a significant improvement in headache intensity 1 year postoperatively in patients with cervical radiculopathy and neck-related headache, but there were no differences between groups over time.","['patients with cervical radiculopathy', 'individuals with neck-related headache after surgery for cervical radiculopathy due to magnetic resonance imaging-verified disc disease', 'after surgery for cervical radiculopathy were included', 'One hundred six patients with neck-related headache and participating', 'Patients With Cervical Disc Disease']","['surgery with either structured postoperative physiotherapy or standard postoperative approach', 'physiotherapy', 'Physiotherapy', 'structured postoperative physiotherapy (n\u200a=\u200a51) or the standard postoperative approach']","['neck-related headache and change in neck muscle endurance, neck mobility, or neck pain', 'current neck pain intensity', 'headache intensity and neck pain intensity, neck muscle endurance, and neck mobility', 'headache intensity', 'current headache intensity', 'Headache intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0742186', 'cui_str': 'Cervical radiculopathy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0477633', 'cui_str': 'Cervical disc disorder'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027532', 'cui_str': 'Skeletal muscle structure of neck'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",106.0,0.221291,"There was a significant improvement in headache intensity 1 year postoperatively in patients with cervical radiculopathy and neck-related headache, but there were no differences between groups over time.","[{'ForeName': 'Jard', 'Initials': 'J', 'LastName': 'Svensson', 'Affiliation': 'aDepartment of Health, Medicine and Caring Sciences, Physiotherapy, Linköping University, Linköping, Sweden bDepartment of Neurosurgery, Linköping University Hospital, Linköping, Sweden cDepartment of Activity and Health, Region Östergötland, Linköping, Sweden dDepartment of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden eNeuro-Orthopedic Center, Region Jönköping County, Jönköping, Sweden fDivision of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden gDepartment of Occupational Therapy and Physiotherapy, Allied Health Professionals Function, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hermansen', 'Affiliation': ''}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Wibault', 'Affiliation': ''}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Löfgren', 'Affiliation': ''}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Dedering', 'Affiliation': ''}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Öberg', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zsigmond', 'Affiliation': ''}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Peolsson', 'Affiliation': ''}]",Spine,['10.1097/BRS.0000000000003430']
963,32621073,"Conscious perception and the modulatory role of dopamine: no effect of the dopamine D2 agonist cabergoline on visual masking, the attentional blink, and probabilistic discrimination.","RATIONALE


Conscious perception is thought to depend on global amplification of sensory input. In recent years, striatal dopamine has been proposed to be involved in gating information and conscious access, due to its modulatory influence on thalamocortical connectivity.
OBJECTIVES


Since much of the evidence that implicates striatal dopamine is correlational, we conducted a double-blind crossover pharmacological study in which we administered cabergoline-a dopamine D2 agonist-and placebo to 30 healthy participants. Under both conditions, we subjected participants to several well-established experimental conscious-perception paradigms, such as backward masking and the attentional blink task.
RESULTS


We found no evidence in support of an effect of cabergoline on conscious perception: key behavioral and event-related potential (ERP) findings associated with each of these tasks were unaffected by cabergoline.
CONCLUSIONS


Our results cast doubt on a causal role for dopamine in visual perception. It remains an open possibility that dopamine has causal effects in other tasks, perhaps where perceptual uncertainty is more prominent.",2020,"We found no evidence in support of an effect of cabergoline on conscious perception: key behavioral and event-related potential (ERP) findings associated with each of these tasks were unaffected by cabergoline.
",['30 healthy participants'],"['cabergoline-a dopamine D2 agonist-and placebo', 'dopamine D2 agonist cabergoline', 'backward masking and the attentional blink task', 'cabergoline', 'dopamine']","['visual masking, the attentional blink, and probabilistic discrimination']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0107994', 'cui_str': 'cabergoline'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C1955945', 'cui_str': 'Attentional Blink'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1955945', 'cui_str': 'Attentional Blink'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}]",30.0,0.0541971,"We found no evidence in support of an effect of cabergoline on conscious perception: key behavioral and event-related potential (ERP) findings associated with each of these tasks were unaffected by cabergoline.
","[{'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Boonstra', 'Affiliation': 'Department of Experimental and Applied Psychology, Institute for Brain and Behavior Amsterdam (iBBA) Vrije Universiteit, Amsterdam, Netherlands. evertboonstra@gmail.com.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'van Schouwenburg', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam Brain and Cognition (ABC), Amsterdam, Netherlands.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Seth', 'Affiliation': 'Department of Informatics Sackler Centre for Consciousness Science, University of Sussex, Brighton, BN1 9QJ, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bauer', 'Affiliation': 'School of Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Zantvoord', 'Affiliation': 'Department of Child and Adolescent Psychiatry, The Bascule, Academic Centre for Child and Adolescent Psychiatry Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Kemper', 'Affiliation': 'Department of Pharmacy, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Lansink', 'Affiliation': 'Swammerdam Institute for Life Sciences, University of Amsterdam, Amsterdam Brain and Cognition (ABC), Amsterdam, Netherlands.'}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Slagter', 'Affiliation': 'Department of Experimental and Applied Psychology, Institute for Brain and Behavior Amsterdam (iBBA) Vrije Universiteit, Amsterdam, Netherlands.'}]",Psychopharmacology,['10.1007/s00213-020-05579-9']
964,32624575,Vitamin D supplementation: a potential therapeutic agent for metastatic colorectal cancer.,"Preclinical and epidemiological evidence suggests that vitamin D may have anti-cancer activities in patients with colorectal cancer. A recently completed, randomised Phase 2 trial of vitamin D 3  supplementation in patients with metastatic colorectal cancer has shown promising results, and a Phase 3 trial is currently underway.",2020,"A recently completed, randomised Phase 2 trial of vitamin D 3  supplementation in patients with metastatic colorectal cancer has shown promising results, and a Phase 3 trial is currently underway.","['patients with colorectal cancer', 'metastatic colorectal cancer', 'patients with metastatic colorectal cancer']","['vitamin D 3  supplementation', 'vitamin D', 'Vitamin D supplementation']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]",[],3.0,0.117711,"A recently completed, randomised Phase 2 trial of vitamin D 3  supplementation in patients with metastatic colorectal cancer has shown promising results, and a Phase 3 trial is currently underway.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA. kimme_ng@dfci.harvard.edu.'}]",British journal of cancer,['10.1038/s41416-020-0958-8']
965,32484446,Promoting Antenatal Care Attendance Through a Text Messaging Intervention in Samoa: Quasi-Experimental Study.,"BACKGROUND


Antenatal care (ANC) has the potential to improve maternal health, but it remains underutilized and unevenly implemented in many low- and middle-income countries. Increasingly, text messaging programs for pregnant women show evidence that they can improve the utilization of ANC during pregnancy; however, gaps remain regarding how implementation affects outcomes.
OBJECTIVE


This study aimed to assess facilitators and barriers to implementation of an SMS text messaging intervention for pregnant women in Samoa and to assess its impact on ANC attendance.
METHODS


This study took place in Upolu, Samoa, from March to August 2014 and employed a quasi-experimental design. Half (n=3) of the public antenatal clinics on the island offered adult pregnant women the SMS text messaging intervention, with 552 women registering for the messages. At the comparison clinics (n=3), 255 women registered and received usual care. The intervention consisted of unidirectional text messages containing health tips and appointment reminders. The outcome of interest was the number of attended antenatal visits. Implementation data were also collected through a survey of the participating midwives (n=7) and implementation notes. Data analysis included a comparison of women's baseline characteristics between the two groups, followed by the use of negative binomial regressions to test for associations between participation in the intervention and increased ANC attendance, controlling for individual characteristics and accounting for the clustering of women within clinics.
RESULTS


The comparison of ANC attendance rates found that women receiving the SMS text messaging intervention attended 15% fewer ANC visits than the comparison group (P=.004), controlling for individual characteristics and clustering. Data analysis of the implementation process suggests that barriers to successful implementation include women registering very late in pregnancy, sharing their phone with others, and inconsistent explanation of the intervention to women.
CONCLUSIONS


These results suggest that unidirectional text messages do not encourage, and might even discourage, ANC attendance in Samoa. Interpreted with other evidence in the literature, these results suggest that SMS text messaging interventions are more effective when they facilitate better communication between patients and health workers. This study is an important contribution to our understanding of when SMS text messaging interventions are and are not effective in improving maternal health care utilization.",2020,"The comparison of ANC attendance rates found that women receiving the SMS text messaging intervention attended 15% fewer ANC visits than the comparison group (P=.004), controlling for individual characteristics and clustering.","['pregnant women in Samoa', 'Half (n=3) of the public antenatal clinics on the island offered adult pregnant women the', '255 women registered and received usual care', '552 women registering for the messages', 'pregnant women']","['SMS text messaging intervention', 'unidirectional text messages containing health tips and appointment reminders', 'SMS text messaging interventions']","['ANC attendance rates', 'number of attended antenatal visits']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0242537', 'cui_str': 'Navigator Islands'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}]",255.0,0.0661568,"The comparison of ANC attendance rates found that women receiving the SMS text messaging intervention attended 15% fewer ANC visits than the comparison group (P=.004), controlling for individual characteristics and clustering.","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Watterson', 'Affiliation': 'School of Public Health, University of California, Berkeley, Berkeley, CA, United States.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Castaneda', 'Affiliation': 'Facebook Research, Menlo Park, CA, United States.'}, {'ForeName': 'Caricia', 'Initials': 'C', 'LastName': 'Catalani', 'Affiliation': 'Design for Health, IDEO, San Francisco, CA, United States.'}]",JMIR mHealth and uHealth,['10.2196/15890']
966,32484448,"Comparing a Social and Communication App, Telephone Intervention, and Usual Care for Diabetes Self-Management: 3-Arm Quasiexperimental Evaluation Study.","BACKGROUND


Many technology-assisted innovations have been used to manage disease. However, most of these innovations are not broadly used by older adults due to their cost. Additionally, disease management through technology-assisted innovations has not been compared with other interventions.
OBJECTIVE


In this study, we tested the employment of a free and widely used social and communication app to help older adults with diabetes manage their distress and glycemic control. We also compared the effectiveness of the app with 2 other methods, namely telephone and conventional health education, and determined which subgroup experiences the most effects within each intervention.
METHODS


Adults aged ≥50 years with type 2 diabetes were recruited from Southern Taiwan (N=231) and were allocated to different 3-month interventions. Informed consent was obtained at the Ministry of Science and Technology and approved by the National Cheng Kung University Hospital Institutional Review Board (No. A-ER-102-425).
RESULTS


Participants in the mobile-based group had significant reductions in hemoglobin A1c compared with the telephone-based and usual care groups (mean changes of -0.4%, 0.1%, and 0.03%, respectively; P=.02). Diabetes-specific distress decreased to a greater extent in the mobile-based group compared to the other 2 groups (mean changes of -5.16, -3.49, and -2.44, respectively, P=.02). Subgroup analyses further revealed that the effects on reducing blood glucose levels in the social and communication app groups were especially evident in patients with lower distress scores, and diabetes-related distress was especially evident in participants who were younger than 60 years or had higher educational levels.
CONCLUSIONS


The findings of this study inform more flexible use of social and communication apps with in-person diabetes education and counselling.",2020,"RESULTS


Participants in the mobile-based group had significant reductions in hemoglobin A1c compared with the telephone-based and usual care groups (mean changes of -0.4%, 0.1%, and 0.03%, respectively; P=.02).","['Adults aged ≥50 years with type 2 diabetes were recruited from Southern Taiwan (N=231', 'older adults with diabetes manage their distress and glycemic control']","['Social and Communication App, Telephone Intervention, and Usual Care']","['blood glucose levels', 'hemoglobin A1c', 'diabetes-related distress', 'Diabetes-specific distress']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.0432114,"RESULTS


Participants in the mobile-based group had significant reductions in hemoglobin A1c compared with the telephone-based and usual care groups (mean changes of -0.4%, 0.1%, and 0.03%, respectively; P=.02).","[{'ForeName': 'Ching-Ju', 'Initials': 'CJ', 'LastName': 'Chiu', 'Affiliation': 'Institute of Gerontology, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yung-Chen', 'Initials': 'YC', 'LastName': 'Yu', 'Affiliation': 'Department of Nursing, National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Ye-Fong', 'Initials': 'YF', 'LastName': 'Du', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Yi-Ching', 'Initials': 'YC', 'LastName': 'Yang', 'Affiliation': 'Department of Family Medicine, National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Jou-Yin', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Department of Public Health, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Wong', 'Affiliation': 'Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Chanuantong', 'Initials': 'C', 'LastName': 'Tanasugarn', 'Affiliation': 'Faculty of Public Health, Mahidol University, Bangkok, Thailand.'}]",JMIR mHealth and uHealth,['10.2196/14024']
967,32480319,Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial.,"OBJECTIVE


The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression.
METHOD


A non-blinded parallel-group randomized controlled trial was conducted. The study population consisted of women attended to three health care centers in Kerman, Iran. Participants were recruited between September and November 2018, and randomized 1:1 to either the intervention group (mobile application access) or control group (no mobile application access). All participants completed the Edinburgh Postnatal Depression Scale (EPDS) at the baseline and 2 months after baseline. Data were analyzed using inferential statistics including chi-square, independent sample t-test, paired t-test and linear regression.
RESULTS


A total of 75 women with an average age of 27 years participated in this study. Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001). However, in the intervention group, the average EPDS score after intervention was 8.18 and in the control group was 15.05, which was statistically significant (p < 0.001).
CONCLUSION


These findings provide proof that providing a CBT program using a mobile application can lead to clinically important improvements in outcomes for mothers who suffer from postpartum depression.",2020,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","['Participants were recruited between September and November 2018', 'postpartum depression in primary care', 'women attended to three health care centers in Kerman, Iran', 'mothers who suffer from postpartum depression', '75 women with an average age of 27 years participated in this study']","['intervention group (mobile application access) or control group (no mobile application access', 'app-based cognitive behavioral therapy program', 'mobile phone applications (App) based cognitive behavioral therapy (CBT']","['Edinburgh Postnatal Depression Scale (EPDS', 'average EPDS score', 'EPDS score']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}]",75.0,0.174326,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Jannati', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Mazhari', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ahmadian', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: ahmadianle@yahoo.com.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Epidemiology and Biostatistics, Kerman University of Medical Sciences, Kerman, Iran.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104145']
968,32485917,Tibial Nerve Block: Supramalleolar or Retromalleolar Approach? A Randomized Trial in 110 Participants.,"Of the five nerves that innervate the foot, the one in which anesthetic blocking presents the greatest difficulty is the tibial nerve. The aim of this clinical trial was to establish a protocol for two tibial nerve block anesthetic techniques to later compare the anesthetic efficiency of retromalleolar blocking and supramalleolar blocking in order to ascertain whether the supramalleolar approach achieved a higher effective blocking rate. A total of 110 tibial nerve blocks were performed. Location of the injection site was based on a prior ultrasound assessment of the tibial nerve. The block administered was 3 mL of 2% mepivacaine. The two anesthetic techniques under study provided very similar clinical results. The tibial nerve success rate was 81.8% for the retromalleolar technique and 78.2% for the supramalleolar technique. No significant differences in absolute latency time ( p  = 0.287), percentage of effective nerve blocks ( p  = 0.634), anesthetic block duration ( p  = 0.895), or pain level during puncture ( p  = 0.847) were found between the two techniques. The greater ease in locating the tibial nerve at the retromalleolar approach could suggest that this is the technique of choice for tibial nerve blocking, especially in the case of professionals new to the field. The supramalleolar technique could be worth considering for those more experienced professionals.",2020,"No significant differences in absolute latency time ( p  = 0.287), percentage of effective nerve blocks ( p  = 0.634), anesthetic block duration ( p  = 0.895), or pain level during puncture ( p  = 0.847) were found between the two techniques.",['110 Participants'],['mepivacaine'],"['absolute latency time', 'pain level', 'tibial nerve success rate', 'anesthetic block duration', 'percentage of effective nerve blocks']","[{'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0025384', 'cui_str': 'Mepivacaine'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}]",110.0,0.0376973,"No significant differences in absolute latency time ( p  = 0.287), percentage of effective nerve blocks ( p  = 0.634), anesthetic block duration ( p  = 0.895), or pain level during puncture ( p  = 0.847) were found between the two techniques.","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Benimeli-Fenollar', 'Affiliation': 'Department of Nursing, University of Valencia, c/Jaume Roig s/n, 46010 Valencia, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Montiel-Company', 'Affiliation': 'Department of Stomatology, University of Valencia, c/Gascó Oliag, 1, 46010 Valencia, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Almerich-Silla', 'Affiliation': 'Department of Stomatology, University of Valencia, c/Gascó Oliag, 1, 46010 Valencia, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Cibrián', 'Affiliation': 'Department of Physiology, University of Valencia, c/Blasco Ibánez, 15, 46010 Valencia, Spain.'}, {'ForeName': 'Cecili', 'Initials': 'C', 'LastName': 'Macián-Romero', 'Affiliation': 'Department of Nursing, University of Valencia, c/Jaume Roig s/n, 46010 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17113860']
969,32485945,"Sprint Interval Running and Continuous Running Produce Training Specific Adaptations, Despite a Similar Improvement of Aerobic Endurance Capacity-A Randomized Trial of Healthy Adults.","The purpose of the present study was to investigate training-specific adaptations to eight weeks of moderate intensity continuous training (CT) and sprint interval training (SIT). Young healthy subjects ( n  = 25; 9 males and 16 females) performed either continuous training (30-60 min, 70-80% peak heart rate) or sprint interval training (5-10 near maximal 30 s sprints, 3 min recovery) three times per week for eight weeks. Maximal oxygen consumption, 20 m shuttle run test and 5·60 m sprint test were performed before and after the intervention. Furthermore, heart rate, oxygen pulse, respiratory exchange ratio, lactate and running economy were assessed at five submaximal intensities, before and after the training interventions. Maximal oxygen uptake increased after CT (before: 47.9 ± 1.5; after: 49.7 ± 1.5 mL·kg -1 ·min -1 ,  p  < 0.05) and SIT (before: 50.5 ± 1.6; after: 53.3 ± 1.5 mL·kg -1 ·min -1 ,  p  < 0.01), with no statistically significant differences between groups. Both groups increased 20 m shuttle run performance and 60 m sprint performance, but SIT performed better than CT at the 4th and 5th 60 m sprint after the intervention ( p  < 0.05). At submaximal intensities, CT, but not SIT, reduced heart rate ( p  < 0.05), whereas lactate decreased in both groups. In conclusion, both groups demonstrated similar improvements of several performance measures including VO 2max , but sprint performance was better after SIT, and CT caused training-specific adaptations at submaximal intensities.",2020,"Both groups increased 20 m shuttle run performance and 60 m sprint performance, but SIT performed better than CT at the 4th and 5th 60 m sprint after the intervention ( p  < 0.05).","['Healthy Adults', 'Young healthy subjects ( n  = 25; 9 males and 16 females']","['continuous training', 'moderate intensity continuous training (CT) and sprint interval training (SIT', 'Sprint Interval Running and Continuous Running Produce Training Specific Adaptations', 'sprint interval training']","['Maximal oxygen consumption, 20 m shuttle run test and 5·60 m sprint test', 'lactate', 'Maximal oxygen uptake', 'heart rate', 'Furthermore, heart rate, oxygen pulse, respiratory exchange ratio, lactate and running economy', '20 m shuttle run performance and 60 m sprint performance', 'several performance measures including VO 2max , but sprint performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",,0.025306,"Both groups increased 20 m shuttle run performance and 60 m sprint performance, but SIT performed better than CT at the 4th and 5th 60 m sprint after the intervention ( p  < 0.05).","[{'ForeName': 'Sigbjørn', 'Initials': 'S', 'LastName': 'Litleskare', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Eystein', 'Initials': 'E', 'LastName': 'Enoksen', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Sandvei', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Støen', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Stensrud', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Egil', 'Initials': 'E', 'LastName': 'Johansen', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}]",International journal of environmental research and public health,['10.3390/ijerph17113865']
970,32490838,The Use of a Smartphone App and an Activity Tracker to Promote Physical Activity in the Management of Chronic Obstructive Pulmonary Disease: Randomized Controlled Feasibility Study.,"BACKGROUND


Chronic obstructive pulmonary disease (COPD) is highly prevalent and significantly affects the daily functioning of patients. Self-management strategies, including increasing physical activity, can help people with COPD have better health and a better quality of life. Digital mobile health (mHealth) techniques have the potential to aid the delivery of self-management interventions for COPD. We developed an mHealth intervention (Self-Management supported by Assistive, Rehabilitative, and Telehealth technologies-COPD [SMART-COPD]), delivered via a smartphone app and an activity tracker, to help people with COPD maintain (or increase) physical activity after undertaking pulmonary rehabilitation (PR).
OBJECTIVE


This study aimed to determine the feasibility and acceptability of using the SMART-COPD intervention for the self-management of physical activity and to explore the feasibility of conducting a future randomized controlled trial (RCT) to investigate its effectiveness.
METHODS


We conducted a randomized feasibility study. A total of 30 participants with COPD were randomly allocated to receive the SMART-COPD intervention (n=19) or control (n=11). Participants used SMART-COPD throughout PR and for 8 weeks afterward (ie, maintenance) to set physical activity goals and monitor their progress. Questionnaire-based and physical activity-based outcome measures were taken at baseline, the end of PR, and the end of maintenance. Participants, and health care professionals involved in PR delivery, were interviewed about their experiences with the technology.
RESULTS


Overall, 47% (14/30) of participants withdrew from the study. Difficulty in using the technology was a common reason for withdrawal. Participants who completed the study had better baseline health and more prior experience with digital technology, compared with participants who withdrew. Participants who completed the study were generally positive about the technology and found it easy to use. Some participants felt their health had benefitted from using the technology and that it assisted them in achieving physical activity goals. Activity tracking and self-reporting were both found to be problematic as outcome measures of physical activity for this study. There was dissatisfaction among some control group members regarding their allocation.
CONCLUSIONS


mHealth shows promise in helping people with COPD self-manage their physical activity levels. mHealth interventions for COPD self-management may be more acceptable to people with prior experience of using digital technology and may be more beneficial if used at an earlier stage of COPD. Simplicity and usability were more important for engagement with the SMART-COPD intervention than personalization; therefore, the intervention should be simplified for future use. Future evaluation will require consideration of individual factors and their effect on mHealth efficacy and use; within-subject comparison of step count values; and an opportunity for control group participants to use the intervention if an RCT were to be carried out. Sample size calculations for a future evaluation would need to consider the high dropout rates.",2020,mHealth interventions for COPD self-management may be more acceptable to people with prior experience of using digital technology and may be more beneficial if used at an earlier stage of COPD.,"['Chronic obstructive pulmonary disease (COPD', '30 participants with COPD', 'Participants, and health care professionals involved in PR delivery, were interviewed about their experiences with the technology', 'Chronic Obstructive Pulmonary Disease', 'Participants who completed the study had better baseline health and more prior experience with digital technology, compared with participants who withdrew']","['SMART-COPD intervention', 'Smartphone App and an Activity Tracker to Promote Physical Activity']","['Simplicity and usability', 'Questionnaire-based and physical activity-based outcome measures']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}]","[{'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1454365', 'cui_str': 'Simplicity (adhesive)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",30.0,0.0578692,mHealth interventions for COPD self-management may be more acceptable to people with prior experience of using digital technology and may be more beneficial if used at an earlier stage of COPD.,"[{'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Bentley', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Powell', 'Affiliation': 'School of Education, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Potter', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'School of Human Sciences, The University of Derby, Derby, United Kingdom.'}, {'ForeName': 'Gail A', 'Initials': 'GA', 'LastName': 'Mountain', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Yvonne Kiera', 'Initials': 'YK', 'LastName': 'Bartlett', 'Affiliation': 'Manchester Centre for Health Psychology, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Farwer', 'Affiliation': 'Library, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Cath', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust, Integrated Community Care Team, Sheffield, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Burns', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Cresswell', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Heather D', 'Initials': 'HD', 'LastName': 'Dunn', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Hawley', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}]",JMIR mHealth and uHealth,['10.2196/16203']
971,32581088,Rituximab as therapy to induce remission after relapse in ANCA-associated vasculitis.,"OBJECTIVES


Evaluation of rituximab and glucocorticoids as therapy to induce remission after relapse in ANCA-associated vasculitis (AAV) in a prospective observational cohort of patients enrolled into the induction phase of the RITAZAREM trial.
METHODS


Patients relapsing with granulomatosis with polyangiitis or microscopic polyangiitis were prospectively enrolled and received remission-induction therapy with rituximab (4×375 mg/m 2 ) and a higher or lower dose glucocorticoid regimen, depending on physician choice: reducing from either 1 mg/kg/day or 0.5 mg/kg/day to 10 mg/day by 4 months. Patients in this cohort achieving remission were subsequently randomised to receive one of two regimens to prevent relapse.
RESULTS


188 patients were studied: 95/188 (51%) men, median age 59 years (range 19-89), prior disease duration 5.0 years (range 0.4-34.5). 149/188 (79%) had previously received cyclophosphamide and 67/188 (36%) rituximab. 119/188 (63%) of relapses had at least one major disease activity item, and 54/188 (29%) received the higher dose glucocorticoid regimen. 171/188 (90%) patients achieved remission by 4 months. Only six patients (3.2% of the study population) did not achieve disease control at month 4. Four patients died in the induction phase due to pneumonia (2), cerebrovascular accident (1), and active vasculitis (1). 41 severe adverse events occurred in 27 patients, including 13 severe infections.
CONCLUSIONS


This large prospective cohort of patients with relapsing AAV treated with rituximab in conjunction with glucocorticoids demonstrated a high level of efficacy for the reinduction of remission in patients with AAV who have relapsed, with a similar safety profile to previous studies.",2020,"41 severe adverse events occurred in 27 patients, including 13 severe infections.
","['Patients relapsing with granulomatosis with polyangiitis or microscopic polyangiitis', 'patients with relapsing AAV treated with', 'patients enrolled into the induction phase of the RITAZAREM trial', '188 patients were studied: 95/188 (51%) men, median age 59 years (range 19-89), prior disease duration 5.0 years', 'patients with AAV who have relapsed, with a similar safety profile to previous studies']","['cyclophosphamide', 'rituximab and glucocorticoids', 'Rituximab', 'remission-induction therapy with rituximab (4×375\u2009mg/m 2 ) and a higher or lower dose glucocorticoid regimen', 'rituximab in conjunction with glucocorticoids', 'rituximab']",['41 severe adverse events'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C3495801', 'cui_str': 'Granulomatosis with polyangiitis'}, {'cui': 'C2347126', 'cui_str': 'Microscopic polyarteritis nodosa'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0035052', 'cui_str': 'Induction of Remission'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",188.0,0.0880274,"41 severe adverse events occurred in 27 patients, including 13 severe infections.
","[{'ForeName': 'Rona M', 'Initials': 'RM', 'LastName': 'Smith', 'Affiliation': 'University of Cambridge, Cambridge, UK ronasmith@doctors.net.uk.'}, {'ForeName': 'Rachel Bronwen', 'Initials': 'RB', 'LastName': 'Jones', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Specks', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Nodale', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Aljayyousi', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, Leicester, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Andrews', 'Affiliation': 'NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds, UK.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Bruchfeld', 'Affiliation': 'Department of Renal Medicine, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Camilleri', 'Affiliation': 'Ipswich Hospital NHS Trust, Ipswich, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Carette', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Chee Kay', 'Initials': 'CK', 'LastName': 'Cheung', 'Affiliation': 'University of Leicester, Leicester, UK.'}, {'ForeName': 'Vimal', 'Initials': 'V', 'LastName': 'Derebail', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Doulton', 'Affiliation': 'East Kent Hospitals University NHS Foundation Trust, Canterbury, Kent, UK.'}, {'ForeName': 'Lindsy', 'Initials': 'L', 'LastName': 'Forbess', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Shouichi', 'Initials': 'S', 'LastName': 'Fujimoto', 'Affiliation': 'University of Miyazaki, Miyazaki, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Furuta', 'Affiliation': 'Chiba University, Chiba, Japan.'}, {'ForeName': 'Ora', 'Initials': 'O', 'LastName': 'Gewurz-Singer', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Harper', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Toshiko', 'Initials': 'T', 'LastName': 'Ito-Ihara', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Khalidi', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Klocke', 'Affiliation': 'Dudley Group NHS Foundation Trust, Dudley, West Midlands, UK.'}, {'ForeName': 'Curry', 'Initials': 'C', 'LastName': 'Koening', 'Affiliation': 'University of Utah Vasculitis Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Komagata', 'Affiliation': 'Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Langford', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lanyon', 'Affiliation': 'Rheumatology, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'Raashid Ahmed', 'Initials': 'RA', 'LastName': 'Luqmani', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science (NDORMs), University of Oxford, Oxford, UK.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Makino', 'Affiliation': 'Okayama Universty Hospital, Okayama, Japan.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'McAlear', 'Affiliation': 'Division of Rheumatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Monach', 'Affiliation': 'Division of Rheumatology, VA Boston Healthcare System, West Roxbury, Massachusetts, USA.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Moreland', 'Affiliation': 'University of Pittsburg, Pittsburg, Pennsylvania, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Mynard', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Nachman', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pagnoux', 'Affiliation': 'Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Pearce', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, Nottingham, UK.'}, {'ForeName': 'Chen Au', 'Initials': 'CA', 'LastName': 'Peh', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Pusey', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Dwarakanathan', 'Initials': 'D', 'LastName': 'Ranganathan', 'Affiliation': ""Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.""}, {'ForeName': 'Rennie L', 'Initials': 'RL', 'LastName': 'Rhee', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spiera', 'Affiliation': 'HSS, New York, New York, USA.'}, {'ForeName': 'Antoine G', 'Initials': 'AG', 'LastName': 'Sreih', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Tesar', 'Affiliation': 'Department of Nephrology, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Walters', 'Affiliation': 'Canberra Hospital, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Weisman', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Wroe', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, Middlesbrough, Middlesbrough, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Merkel', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jayne', 'Affiliation': 'University of Cambridge, Cambridge, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216863']
972,32588071,Invited Discussion on: Evaluation of the Sensitivity of the Nipple-Areola Complex in Patients Undergoing Breast Ptosis Correction with Periareolar Dermis Release: A Randomized Controlled Trial.,,2020,,['Patients Undergoing Breast Ptosis Correction with Periareolar Dermis Release'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",[],[],,0.0915365,,"[{'ForeName': 'Maurice Y', 'Initials': 'MY', 'LastName': 'Nahabedian', 'Affiliation': 'Virginia Commonwealth University, Inova Branch, National Center for Plastic Surgery, 7601 Lewinsville Dr., #400, McLean, VA, 22102, USA. DrNahabedian@aol.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01839-3']
973,32592335,Treatment of oral lichen planus with mucoadhesive mycophenolate mofetil patch: A randomized clinical trial.,"OBJECTIVES


Oral lichen planus (OLP) is a chronic inflammatory disease of unknown etiology which is known as a premalignant disease. A complete cure has not been found for this condition. Mycophenolate mofetil (MMF) is a new drug that seems to be effective in improving OLP lesions. But there are no studies on the efficacy of mucoadhesive form of MMF in ulcerative OLP. Therefore, this study was performed to determine the therapeutic effect of MMF mucoadhesive on OLP lesions.
MATERIAL AND METHODS


Twenty-seven patients with OLP, were enrolled in two groups. All the patients were instructed to place the MMF 2% mucoadhesive on the lesion twice daily for 4 weeks. Lesion size was measured by a sterile digital caulis (mm) and the severity of burning sensation and pain by visual analogue scale (VAS; cm) at baseline and weekly follow-ups.
RESULTS


There was no significant difference in burning sensation and lesion size at Weeks 1, 2, and 3 in both groups. In Group A, at Week 4, there was significant reduction in pain and burning sensation and lesion size on both sides (p = .048, .012). The difference in lesion size on control sides was not significant. In Group B, at Week 4, there was significant reduction in pain and burning sensation and lesion size (p = .004). No side effects were reported by the patients.
CONCLUSIONS


Based on the results, 2% MMF mucoadhesive was effective in decreasing burning sensation and pain severity and ulcer size of ulcerative OLP and the effect was time-dependent.",2020,"In Group A, at Week 4, there was significant reduction in pain and burning sensation and lesion size on both sides (p = .048, .012).","['Twenty-seven patients with OLP, were enrolled in two groups']","['Mycophenolate mofetil (MMF', 'Oral lichen planus (OLP', 'MMF mucoadhesive', 'mucoadhesive mycophenolate mofetil patch']","['burning sensation and lesion size', 'lesion size on control sides', 'burning sensation and pain severity and ulcer size of ulcerative OLP', 'severity of burning sensation and pain by visual analogue scale (VAS; cm', 'Lesion size', 'pain and burning sensation and lesion size', 'side effects']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",27.0,0.0435425,"In Group A, at Week 4, there was significant reduction in pain and burning sensation and lesion size on both sides (p = .048, .012).","[{'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Samiee', 'Affiliation': 'Post Graduate Student of Oral and Maxillofacial Medicine, Oral and Maxillofacial Medicine Department, Mashhad Dental Faculty, Mashhad, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Taghavi Zenuz', 'Affiliation': 'Department of Oral and Maxillofacial Medicine, School of Dentistry, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Masumeh', 'Initials': 'M', 'LastName': 'Mehdipour', 'Affiliation': 'Department of Oral and Maxillofacial Medicine, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Shokri', 'Affiliation': 'Department of Pharmaceutics, School of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Clinical and experimental dental research,['10.1002/cre2.302']
974,32602170,Genetic Variant in CHRNA5 and Response to Varenicline and Combination Nicotine Replacement in a Randomized Placebo-Controlled Trial.,"It is unclear if genetic variants affect smoking cessation treatment response. This study tested whether variants in the cholinergic receptor nicotinic alpha 5 subunit (CHRNA5) predict response to smoking cessation medication by directly comparing the two most effective smoking cessation pharmacotherapies. In this genotype-stratified randomized, double-blind, placebo-controlled clinical trial (May 2015-August 2019 in St Louis, Missouri), smokers were randomized by genotype in blocks of six (1:1:1 ratio) to three conditions: 12 weeks of placebo (n = 273), combination nicotine patch and lozenge (combination nicotine replacement therapy, cNRT, n = 275), or varenicline (n = 274). All participants received counseling and were followed for 12 months. The primary end point was biochemically verified 7-day point prevalence abstinence at the end of treatment (EOT, week 12). Trial registration and eligibility criteria are on clinicaltrials.gov (https://clinicaltrials.gov/) (NCT02351167). We conducted the genetic analyses separately for 516 European ancestry (EA) smokers and 306 non-EA smokers (including 270 African American smokers). In African American smokers, there was a genotype-by-treatment interaction for EOT abstinence (χ 2   = 10.7, degrees of freedom = 2. P = 0.0049): specifically, cNRT was more effective in smokers with rs16969968 GG genotype than was placebo, while varenicline was more effective in smokers of GA/AA genotypes. In EA ancestry smokers, there was no significant genotype-by-treatment interaction. In the whole sample, although both were effective at EOT, only varenicline, and not cNRT, was significantly effective relative to placebo at 6-month follow-up. Importantly, this study suggests that genetic information can further enhance smoking cessation treatment effectiveness.",2020,"In the whole sample, only varenicline, and not cNRT, produced higher abstinence at 6-month follow-up.","['African American smokers', '516 European American (EA) smokers and 306 non-EA smokers (including 270 African American smokers']","['varenicline, and not cNRT', 'placebo', 'cholinergic receptor nicotinic alpha 5 subunit (CHRNA5', 'Varenicline and Combination Nicotine Replacement', 'varenicline', 'combination nicotine patch and lozenge (cNRT, n=275), or varenicline', 'cNRT']",['7-day point prevalence abstinence'],"[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319603', 'cui_str': '270'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034792', 'cui_str': 'Cholinergic receptor'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",,0.197091,"In the whole sample, only varenicline, and not cNRT, produced higher abstinence at 6-month follow-up.","[{'ForeName': 'Li-Shiun', 'Initials': 'LS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bray', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Smock', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Jingling', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Stoneking', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Culverhouse', 'Affiliation': 'John T. Milliken Department of Medicine, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Saccone', 'Affiliation': 'Department of Genetics, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Amos', 'Affiliation': 'Department of Biomedical Data Science, Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Carney', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Jorenby', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Bierut', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1971']
975,32601329,Suture type used for perineal injury repair and sexual function: a randomised controlled trial.,"The type of suture used to repair perineal injury may be associated with this healing process and subsequent sexual function. This study aims to assess whether the suture technique used (continuous or interrupted) has an impact on a woman's sexual function following childbirth. A single-blind randomised clinical trial was conducted with primiparous women who had experienced a perineal injury during childbirth. A computer-generated random number table was applied to allocate women to each group. Data were collected on sociodemographic variables, variables associated with childbirth, and outcomes during the 3 months after childbirth. Mean difference was used to assess the influence of the suture type on outcomes. Multivariate analyses were carried out to adjust for unbalanced variables after randomisation. Seventy women participated in the intervention group (continuous suture) and 64 women in the control group (interrupted suture). The women in the intervention group scored high for sexual desire, adjusted mean difference (aMD) = 1.8, 95% CI = 1.1-2.6 (p < 0.001); the same happened with arousal (aMD = 1.7, 95% CI = 0.8-2.5, p < 0.001). In the intervention group, orgasm was more easily reached, aMD = 0.8, 95% CI = 0.4-1.1 (p < 0.001). Women who received a continuous suture indicated they felt less discomfort (p < 0.001). Women who had a continuous suture reported better postpartum sexual function.Trial registration: ClinicalTrials.gov NCT03825211 posted 31/01/ 2019.",2020,"In the intervention group, orgasm was more easily reached, aMD = 0.8, 95% CI = 0.4-1.1 (p < 0.001).","['primiparous women who had experienced a perineal injury during childbirth', 'Seventy women participated in the intervention group (continuous suture) and 64 women in the', ""woman's sexual function following childbirth""]","['suture technique used (continuous or interrupted', 'control group (interrupted suture', 'Suture type used for perineal injury repair and sexual function']","['discomfort', 'sexual desire', 'postpartum sexual function']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C3544174', 'cui_str': 'Perineal injury'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0038968', 'cui_str': 'Suturing techniques'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0502420', 'cui_str': 'Suture structure'}, {'cui': 'C3544174', 'cui_str': 'Perineal injury'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}]",70.0,0.282807,"In the intervention group, orgasm was more easily reached, aMD = 0.8, 95% CI = 0.4-1.1 (p < 0.001).","[{'ForeName': 'Juan Miguel', 'Initials': 'JM', 'LastName': 'Martínez-Galiano', 'Affiliation': 'Department of Nursing, University of Jaen, Jaén, Spain. juanmimartinezg@hotmail.com.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Arredondo-López', 'Affiliation': 'Andalusian Health Service, Andalucia, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Hidalgo-Ruiz', 'Affiliation': 'Andalusian Health Service, Andalucia, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Narvaez-Traverso', 'Affiliation': 'Andalusian Health Service, Andalucia, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Lopez-Morón', 'Affiliation': 'Andalusian Health Service, Andalucia, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Delgado-Rodriguez', 'Affiliation': 'CIBER Epidemiology and Public Health (CIBERESP), Madrid, Spain.'}]",Scientific reports,['10.1038/s41598-020-67659-2']
976,32610351,Impact of Navigated Task-specific fMRI on Direct Cortical Stimulation.,"BACKGROUND AND STUDY AIMS


Cortical mapping (CM) with direct cortical stimulation (DCS) in awake craniotomy is used to preserve cognitive functions such as language. Nevertheless, patient collaboration during this procedure is influenced by previous neurological symptoms and growing discomfort with DCS duration. Our study aimed to evaluate the impact of navigated task-specific functional magnetic resonance imaging (nfMRI) on the practical aspects of DCS.
MATERIAL AND METHODS


We recruited glioma patients scheduled for awake craniotomy for prior fMRI-based CM, acquired during motor and language tasks (i.e., verb generation, semantic and syntactic decision tasks). Language data was combined to generate a probabilistic map indicating brain regions activated with more than one paradigm. Presurgical neurophysiological language tests (i.e., verb generation, picture naming, and semantic tasks) were also performed. We considered for subsequent study only the patients with a minimum rate of correct responses of 50% in all tests. These patients were then randomized to perform intraoperative language CM either using the multimodal approach (mCM), using nfMRI and DCS combined, or electrical CM (eCM), with DCS alone. DCS was done while the patient performed picture naming and nonverbal semantic decision tasks. Methodological features such as DCS duration, number of stimuli, total delivered stimulus duration per task, and frequency of seizures were analyzed and compared between groups. The correspondence between positive responses obtained with DCS and nfMRI was also evaluated.
RESULTS


Twenty-one surgeries were included, thirteen of which using mCM (i.e., test group). Patients with lower presurgical neuropsychological performance (correct response rate between 50 and 80% in language tests) showed a decreased DCS duration in comparison with the control group. None of the compared methodological features showed differences between groups. Correspondence between DCS and nfMRI was 100/84% in the identification of the precentral gyrus for motor function/opercular frontal inferior gyrus for language function, respectively.
CONCLUSION


Navigated fMRI data did not influence DCS in practice. Presurgical language disturbances limited the applicability of DCS mapping in awake surgery.",2020,"Correspondence between DCS and nfMRI was 100/84% in the identification of the precentral gyrus for motor function/opercular frontal inferior gyrus for language function, respectively.
","['awake surgery', 'We recruited glioma patients scheduled for awake craniotomy for prior fMRI-based CM, acquired during motor and language tasks (i.e., verb generation, semantic and syntactic decision tasks', 'Twenty-one surgeries were included, thirteen of which using mCM (i.e., test group']","['navigated task-specific functional magnetic resonance imaging (nfMRI', 'direct cortical stimulation (DCS', 'Navigated Task-specific fMRI', 'intraoperative language CM either using the multimodal approach (mCM), using nfMRI and DCS combined, or electrical CM (eCM), with DCS alone']","['presurgical neuropsychological performance (correct response rate', 'Presurgical neurophysiological language tests (i.e., verb generation, picture naming, and semantic tasks', 'DCS duration, number of stimuli, total delivered stimulus duration per task, and frequency of seizures', 'DCS duration']","[{'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0439201', 'cui_str': 'um'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0023016', 'cui_str': 'Language Tests'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449802', 'cui_str': 'Number of stimuli'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}]",21.0,0.173939,"Correspondence between DCS and nfMRI was 100/84% in the identification of the precentral gyrus for motor function/opercular frontal inferior gyrus for language function, respectively.
","[{'ForeName': 'Joao', 'Initials': 'J', 'LastName': 'Leote', 'Affiliation': 'Faculdade de Ciências da Universidade de Lisboa, Instituto de Biofísica e Engenharia Biomédica, Lisboa, Portugal.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Loução', 'Affiliation': 'Institute of Neurosciences and Medicine, INM 4, Julich, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Viegas', 'Affiliation': 'Department of Neurosurgery and Critical Care, Hospital Garcia de Orta EPE, Almada, Portugal.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lauterbach', 'Affiliation': 'Department of Neuroradiology, Sociedade Portuguesa de Ressonância Magnética, Lisboa, Portugal.'}, {'ForeName': 'António', 'Initials': 'A', 'LastName': 'Perez-Hick', 'Affiliation': 'Department of Neurosurgery and Critical Care, Hospital Garcia de Orta EPE, Almada, Portugal.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Monteiro', 'Affiliation': 'Department of Neurosurgery and Critical Care, Hospital Garcia de Orta EPE, Almada, Portugal.'}, {'ForeName': 'Rita G', 'Initials': 'RG', 'LastName': 'Nunes', 'Affiliation': 'Department of Bioengineering and Institute for Systems and Robotics (ISR/IST), LARSyS, Universidade de Lisboa Instituto Superior Técnico Campus Alameda, Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Hugo A', 'Initials': 'HA', 'LastName': 'Ferreira', 'Affiliation': 'Faculdade de Ciências da Universidade de Lisboa, Instituto de Biofísica e Engenharia Biomédica, Lisboa, Portugal.'}]","Journal of neurological surgery. Part A, Central European neurosurgery",['10.1055/s-0040-1712496']
977,32615392,The effects of 6 mo of supplementation with probiotics and synbiotics on gut microbiota in the adults with prediabetes: A double blind randomized clinical trial.,"OBJECTIVES


The evidence of 16S rRNA genes in the gut microbiota distinguished a higher Firmicutes-to-Bacteroidetes ratio in individuals who were obese and had diabetes than in a healthy cohort. So, it seems that the modulation of intestinal microbial ecology by pro-/pre-/synbiotics may contribute to the progression and prevention of metabolic diseases. The aim of this study was to assess the effects of probiotics and synbiotic supplementation on the modification of the intestinal microbiome in adults with prediabetes.
METHODS


In a randomized, double-blinded, placebo-controlled clinical trial, 120 patients with prediabetes were randomly assigned to consume 6 g/d of either a placebo containing maltodextrin (control) or multispecies probiotic or inulin-based synbiotic for 6 mo. Fecal samples were obtained at baseline and after 6 mo of supplementation. Dietary intake was assessed throughout the study (at baseline and after 3 and 6 mo). Total energy, macronutrients, and dietary fiber were calculated using a dietary program Nutritionist 4. DNA was extracted from fecal samples and the numbers of Clostridium perfringens (the represent of phylum Firmicutes), Bacteroides fragilis (the representative of Bacteroidetes) and Escherichia coli (as universal bacteria) were determined by quantitative real-time polymerase chain reactions (qPCR). The changes in the relative abundance of the two fecal bacteria before and after supplementation were analyzed and compared within and between groups.
RESULTS


There were no significant changes in dietary intake during the study. Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02). Synbiotic had no significant effect on the changes in the bacteria. There were no significant differences between the three groups.
CONCLUSION


The results of this study suggest that manipulation of the human gut microbiome by using probiotics could provide a potential therapeutic approach in the prevention and management of obesity and metabolic disorders such as diabetes.",2020,"Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02).","['120 patients with prediabetes', 'adults with prediabetes']","['dietary program', 'probiotics and synbiotic supplementation', 'placebo containing maltodextrin (control) or multispecies probiotic or inulin-based synbiotic', 'Synbiotic', 'supplementation with probiotics and synbiotics', 'placebo']","['dietary intake', 'gut microbiota', 'bacteria', 'Total energy, macronutrients, and dietary fiber', 'abundance of the B. fragilis-to-E.coli ratio', 'Dietary intake', 'Fecal samples']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",120.0,0.249584,"Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02).","[{'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Kassaian', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: nkassaian@gmal.com.'}, {'ForeName': 'Awat', 'Initials': 'A', 'LastName': 'Feizi', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center and Department of Biostatistics and Epidemiology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: awat_feiz@hlth.mui.ac.ir.'}, {'ForeName': 'Soodabeh', 'Initials': 'S', 'LastName': 'Rostami', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: srostami1876@gmail.com.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Aminorroaya', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: aminorroaya@med.mui.ac.ir.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Yaran', 'Affiliation': 'Nosocomial Infection Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: yaranmajid@yahoo.com.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Amini', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: M_amini@med.mui.ac.ir.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110854']
978,32618032,The role of novelty and fat and sugar concentration in food selection by captive tufted capuchins (Sapajus apella).,"Capuchins, like other primates, use feedback from sensory cues and digestion to make decisions about which foods to consume and which to avoid. However, little is known about how capuchins make consumption decisions when simultaneously presented with novel and familiar foods, or how food familiarity and macronutrient concentration together influence food choice, topics with potential implications for developmental and health research. In this study, we evaluated the role of familiarity, as well as fat and sugar concentration, in the food selections of captive tufted capuchins (Sapajus apella). In the first experiment, over 10 sessions, subjects were assigned to either a group that chose between one familiar and one novel food item both high in fat or sugar (high condition), or to a group that chose between one familiar and one novel food item both low in fat or sugar (low condition). In the second experiment, subjects were divided into three groups, familiarized with food over five feeding sessions, and then offered the familiarized food and a novel food that varied in fat or sugar for 10 sessions. When offered foods high in fat, capuchins showed no clear signs of neophobia, forming an initial preference for the novel food, rejecting foods less frequently, and selecting foods faster than when offered foods low in fat. These trends were generally not observed in response to foods with sugar. When presented with options that varied in macronutrient concentration, subjects showed an initial interest in the novel food irrespective of whether it was high in fat or sugar, yet formed a final preference for the higher-concentration item. Findings suggest that the concentration of fat or sugar in novel foods may be an important mediator of exploratory behavior and that capuchins rely on immediate feedback from taste and other sensory cues to make consumption decisions.",2020,"When offered foods high in fat, capuchins showed no clear signs of neophobia, forming an initial preference for the novel food, rejecting foods less frequently, and selecting foods faster than when offered foods low in fat.",[],"['familiarized with food over five feeding sessions, and then offered the familiarized food and a novel food that varied in fat or sugar for 10 sessions', 'one familiar and one novel food item both high in fat or sugar (high condition), or to a group that chose between one familiar and one novel food item both low in fat or sugar (low condition']",[],[],"[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",[],,0.0156631,"When offered foods high in fat, capuchins showed no clear signs of neophobia, forming an initial preference for the novel food, rejecting foods less frequently, and selecting foods faster than when offered foods low in fat.","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Heuberger', 'Affiliation': 'Center on Social Dynamics and Policy, The Brookings Institution, Washington, District of Columbia.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Paukner', 'Affiliation': 'School of Social Sciences, Nottingham Trent University, Nottingham, Nottingham, UK.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Wooddell', 'Affiliation': 'Laboratory of Comparative Ethology, National Institute of Child Health and Human Development, Poolesville, Maryland.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Kasman', 'Affiliation': 'Center on Social Dynamics and Policy, The Brookings Institution, Washington, District of Columbia.'}, {'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Hammond', 'Affiliation': 'Center on Social Dynamics and Policy, The Brookings Institution, Washington, District of Columbia.'}]",American journal of primatology,['10.1002/ajp.23165']
979,32639280,Predictive and prognostic value of magnesium serum level in FOLFIRI plus cetuximab or bevacizumab treated patients with stage IV colorectal cancer: results from the FIRE-3 (AIO KRK-0306) study.,"Magnesium wasting is a frequent side effect of epidermal growth factor receptor (EGFR)-antibody treatment as magnesium-absorption mechanisms are dependent on EGFR signaling. EGFR-inhibition results in decreased renal reabsorption. There is evidence that hypomagnesemia during cetuximab treatment correlates with response. The prognostic role of hypomagnesemia during bevacizumab treatment has not been studied yet. Here, we evaluate the prognostic value of hypomagnesemia in patients with metastatic colorectal cancer treated with FOLFIRI plus cetuximab or bevacizumab as first-line therapy. A total of 391 of 752 patients of the firstline irinotecan study population had magnesium levels measured at baseline and for the first three cycles (6 weeks) of treatment. Of those, 240 had Rat Sarkoma wildtype tumors. Overall hypomagnesemia was more common in the cetuximab compared to the bevacizumab arm (80 vs. 43%, P < 0.005). During therapy, magnesium showed a time-dependent decrease to 80% of baseline in the cetuximab and to 89% in the bevacizumab arm. Whereas magnesium continued to decrease over time in the cetuximab-treated patients, it remained stable in the bevacizumab-treated. Overall response rate (ORR) was associated with higher magnesium at week 6 (20.9 vs. 79.1%, P = 0.041). Bevacizumab-treated patients with magnesium levels below the median value at week 6 had a significantly longer progression-free survival (PFS; 11.7 vs. 9.9 months, P = 0.034; hazard ratio 0.73) and a trend towards longer overall survival (OS) (29.6 vs. 23.2 months, P = 0.089; hazard ratio 0.77). Hypomagnesemia at predefined time points and magnesium nadir had no significant effect on ORR, OS and PFS in the cetuximab arm. Our data show different magnesium kinetics in patients with metastatic colorectal cancer treated with cetuximab or bevacizumab. For patients treated with cetuximab, hypomagnesemia did not have an impact on response and survival. Hypomagnesemia might have a prognostic value in bevacizumab treatment.",2020,"Hypomagnesemia at predefined time points and magnesium nadir had no significant effect on ORR, OS and PFS in the cetuximab arm.","['treated patients with stage IV colorectal cancer', 'A total of 391 of 752 patients of the firstline irinotecan study population had', 'patients with metastatic colorectal cancer treated with', '240 had Rat Sarkoma wildtype tumors']","['FOLFIRI plus cetuximab or bevacizumab', 'cetuximab or bevacizumab', 'bevacizumab', 'Bevacizumab']","['ORR, OS and PFS', 'Overall response rate (ORR', 'renal reabsorption', 'progression-free survival', 'overall survival (OS', 'hypomagnesemia', 'Hypomagnesemia', 'Overall hypomagnesemia', 'prognostic value of hypomagnesemia', 'response and survival', 'magnesium levels']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0677950', 'cui_str': 'Colorectal cancer stage IV'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2610986', 'cui_str': 'Renal Absorption'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}]",,0.154894,"Hypomagnesemia at predefined time points and magnesium nadir had no significant effect on ORR, OS and PFS in the cetuximab arm.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schulz', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Heinrich', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haas', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Julian W', 'Initials': 'JW', 'LastName': 'Holch', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Fraccaroli', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'ClinAssess GmbH, Leverkusen.'}, {'ForeName': 'Jobst C', 'Initials': 'JC', 'LastName': 'von Einem', 'Affiliation': 'Division of Hematology, Oncology and Tumor Immunology (CCM), Department of Medicine, Charité - Universitaetsmedizin Berlin, Berlin.'}, {'ForeName': 'Dominik P', 'Initials': 'DP', 'LastName': 'Modest', 'Affiliation': 'Division of Hematology, Oncology and Tumor Immunology (CCM), Department of Medicine, Charité - Universitaetsmedizin Berlin, Berlin.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Fischer von Weikersthal', 'Affiliation': 'Department of Hematology and Oncology, Gesundheitszentrum St. Marien, Amberg.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kullmann', 'Affiliation': 'Department of Medicine I, Klinikum Weiden, Weiden.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': 'Department of Medicine II, University Hospital, Johannes Gutenberg University Clinic Mainz, Mainz, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Scheithauer', 'Affiliation': 'Department of Internal Medicine I and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Jung', 'Affiliation': 'Institute of Pathology, University of Munich, Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Division of Hematology, Oncology and Tumor Immunology (CCM), Department of Medicine, Charité - Universitaetsmedizin Berlin, Berlin.'}]",Anti-cancer drugs,['10.1097/CAD.0000000000000965']
980,32638095,Predictors of complete miscarriage after expectant management or misoprostol treatment of non-viable early pregnancy in women with vaginal bleeding.,"PURPOSE


To identify predictors of complete miscarriage after expectant management or misoprostol treatment of non-viable early pregnancy in women with vaginal bleeding.
METHODS


This was a planned secondary analysis of data from a published randomized controlled trial comparing expectant management with vaginal single dose of 800 µg misoprostol treatment of women with embryonic or anembryonic miscarriage. Predefined variables-serum-progesterone, serum-β-human chorionic gonadotropin, parity, previous vaginal deliveries, gestational age, clinical symptoms (bleeding and pain), mean diameter and shape of the gestational sac, crown-rump-length, type of miscarriage, and presence of blood flow in the intervillous space-were tested as predictors of treatment success (no gestational sac in the uterine cavity and maximum anterior-posterior intracavitary diameter was ≤ 15 mm as measured with transvaginal ultrasound on a sagittal view) in univariable and multivariable logistic regression.
RESULTS


Variables from 174 women (83 expectant management versus 91 misoprostol) were analyzed for prediction of complete miscarriage at ≤ 17 days. In patients managed expectantly, the rate of complete miscarriage was 62.7% (32/51) in embryonic miscarriages versus 37.5% (12/32) in anembryonic miscarriages (P = 0.02). In multivariable logistic regression, the likelihood of success increased with increasing gestational age, increasing crown-rump-length and decreasing gestational sac diameter. Misoprostol treatment was successful in 80.0% (73/91). No variable predicted success of misoprostol treatment.
CONCLUSIONS


Complete miscarriage after expectant management is significantly more likely in embryonic miscarriage than in anembryonic miscarriage. Gestational age, crown-rump-length, and gestational sac diameter are independent predictors of success of expectant management. Predictors of treatment success may help counselling women with early miscarriage.",2020,"CONCLUSIONS


Complete miscarriage after expectant management is significantly more likely in embryonic miscarriage than in anembryonic miscarriage.","['women with vaginal bleeding', '174 women (83 expectant management versus 91', 'women with embryonic or anembryonic miscarriage', 'counselling women with early miscarriage']","['expectant management with vaginal single dose of 800\xa0µg misoprostol', 'Misoprostol', 'misoprostol']","['Predefined variables-serum-progesterone, serum-β-human chorionic gonadotropin, parity, previous vaginal deliveries, gestational age, clinical symptoms (bleeding and pain), mean diameter and shape of the gestational sac, crown-rump-length, type of miscarriage, and presence of blood flow', 'rate of complete miscarriage', 'embryonic miscarriage']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C4324508', 'cui_str': 'Early miscarriage'}]","[{'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0428410', 'cui_str': 'Serum progesterone measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0553498', 'cui_str': 'Gestation Sac'}, {'cui': 'C2825540', 'cui_str': 'Crown rump length'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C1306041', 'cui_str': 'Complete miscarriage'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}]",,0.09524,"CONCLUSIONS


Complete miscarriage after expectant management is significantly more likely in embryonic miscarriage than in anembryonic miscarriage.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fernlund', 'Affiliation': 'Department of Obstetrics and Gynecology, Skåne University Hospital, Jan Waldenströms gata 47, 20502, Malmö, SE, Sweden. anna.fernlund@skane.se.'}, {'ForeName': 'Ligita', 'Initials': 'L', 'LastName': 'Jokubkiene', 'Affiliation': 'Department of Obstetrics and Gynecology, Skåne University Hospital, Jan Waldenströms gata 47, 20502, Malmö, SE, Sweden.'}, {'ForeName': 'Povilas', 'Initials': 'P', 'LastName': 'Sladkevicius', 'Affiliation': 'Department of Obstetrics and Gynecology, Skåne University Hospital, Jan Waldenströms gata 47, 20502, Malmö, SE, Sweden.'}, {'ForeName': 'Lil', 'Initials': 'L', 'LastName': 'Valentin', 'Affiliation': 'Department of Obstetrics and Gynecology, Skåne University Hospital, Jan Waldenströms gata 47, 20502, Malmö, SE, Sweden.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05672-6']
981,32580739,"The impact of gravidity, symptomatology and timing of infection on placental malaria.","BACKGROUND


Placental malaria is associated with increased risk of adverse perinatal outcomes. While primigravidity has been reported as a risk factor for placental malaria, little is known regarding the relationship between gravidity, symptomatology and timing of Plasmodium falciparum infection and the development of placental malaria.
METHODS


The aim of this study was to investigate the relationship between the development of placental malaria and gravidity, timing of infection, and presence of symptoms. This is a secondary analysis of data from a double-blind randomized control trial of intermittent preventive therapy during pregnancy in Uganda. Women were enrolled from 12 to 20 weeks gestation and followed through delivery. Exposure to malaria parasites was defined as symptomatic (fever with positive blood smear) or asymptomatic (based on molecular detection of parasitaemia done routinely every 4 weeks). The primary outcome was placental malaria diagnosed by histopathology, placental blood smear, and/or placental blood loop-mediated isothermal amplification. Multivariate analyses were performed using logistic regression models. Subgroup analysis was performed based on the presence of symptomatic malaria, gravidity, and timing of infection.
RESULTS


Of the 228 patients with documented maternal infection with malaria parasites during pregnancy, 101 (44.3%) had placental malaria. Primigravidity was strongly associated with placental malaria (aOR 8.90, 95% CI 4.34-18.2, p < 0.001), and each episode of malaria was associated with over a twofold increase in placental malaria (aOR 2.35, 95% CI 1.69-3.26, p < 0.001). Among multigravid women, the odds of placental malaria increased by 14% with each advancing week of gestation at first documented infection (aOR 1.14, 95% CI 1.02-1.27, p = 0.02). When stratified by the presence of symptoms, primigravidity was only associated with placental malaria in asymptomatic women, who had a 12-fold increase in the odds of placental malaria (aOR 12.19, 95% CI 5.23-28.43, p < 0.001).
CONCLUSIONS


Total number of P. falciparum infections in pregnancy is a significant predictor of placental malaria. The importance of timing of infection on the development of placental malaria varies based on gravidity. In primigravidas, earlier asymptomatic infections were more frequently identified in those with placental malaria, whereas in multigravidas, parasitaemias detected later in gestation were associated with placental malaria. Earlier initiation of an effective intermittent preventive therapy may help to prevent placental malaria and improve birth outcomes, particularly in primigravid women.",2020,"Primigravidity was strongly associated with placental malaria (aOR 8.90, 95% CI 4.34-18.2, p < 0.001), and each episode of malaria was associated with over a twofold increase in placental malaria (aOR 2.35, 95% CI 1.69-3.26, p < 0.001).","['228 patients with documented maternal infection with malaria parasites during pregnancy, 101 (44.3%) had placental malaria', 'pregnancy in Uganda', 'Women were enrolled from 12 to 20\xa0weeks gestation and followed through delivery']",['intermittent preventive therapy'],"['placental malaria and improve birth outcomes', 'placental malaria diagnosed by histopathology, placental blood smear, and/or placental blood loop-mediated isothermal amplification', 'placental malaria', 'placental malaria and gravidity, timing of infection, and presence of symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0239997', 'cui_str': 'Maternal infection'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243140', 'cui_str': 'histopathology'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",228.0,0.148916,"Primigravidity was strongly associated with placental malaria (aOR 8.90, 95% CI 4.34-18.2, p < 0.001), and each episode of malaria was associated with over a twofold increase in placental malaria (aOR 2.35, 95% CI 1.69-3.26, p < 0.001).","[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Tran', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics Gynecology & Reproductive Sciences, University of California San Francisco, 513 Parnassus Ave. HSE16, Box 0556, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Morgan L', 'Initials': 'ML', 'LastName': 'Cheeks', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics Gynecology & Reproductive Sciences, University of California San Francisco, 513 Parnassus Ave. HSE16, Box 0556, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Kakuru', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Muhindo', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Natureeba', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Nakalembe', 'Affiliation': 'Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ategeka', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Patience', 'Initials': 'P', 'LastName': 'Nayebare', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Kamya', 'Affiliation': 'Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Havlir', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Feeney', 'Affiliation': 'Division of Pediatric Infectious Diseases, Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Dorsey', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Gaw', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics Gynecology & Reproductive Sciences, University of California San Francisco, 513 Parnassus Ave. HSE16, Box 0556, San Francisco, CA, 94143, USA. stephanie.gaw@ucsf.edu.'}]",Malaria journal,['10.1186/s12936-020-03297-3']
982,32589153,Evaluation of the Tobbstop Mobile App for Smoking Cessation: Cluster Randomized Controlled Clinical Trial.,"BACKGROUND


Mobile apps provide an accessible way to test new health-related methodologies. Tobacco is still the primary preventable cause of death in industrialized countries, constituting an important public health issue. New technologies provide novel opportunities that are effective in the cessation of smoking tobacco.
OBJECTIVE


This paper aims to evaluate the efficacy and usage of a mobile app for assisting adult smokers to quit smoking.
METHODS


We conducted a cluster randomized clinical trial. We included smokers older than 18 years who were motivated to stop smoking and used a mobile phone compatible with our mobile app. We carried out follow-up visits at 15, 30, and 45 days, and at 2, 3, 6, and 12 months. Participants of the intervention group had access to the Tobbstop mobile app designed by the research team. The primary outcomes were continuous smoking abstinence at 3 and 12 months.
RESULTS


A total of 773 participants were included in the trial, of which 602 (77.9%) began the study on their D-Day. Of participants in the intervention group, 34.15% (97/284) did not use the app. The continuous abstention level was significantly larger in the intervention group participants who used the app than in those who did not use the app at both 3 months (72/187, 38.5% vs 13/97, 13.4%; P<.001) and 12 months (39/187, 20.9% vs 8/97, 8.25%; P=.01). Participants in the intervention group who used the app regularly and correctly had a higher probability of not being smokers at 12 months (OR 7.20, 95% CI 2.14-24.20; P=.001) than the participants of the CG.
CONCLUSIONS


Regular use of an app for smoking cessation is effective in comparison with standard clinical practice.
TRIAL REGISTRATION


Clinicaltrials.gov NCT01734421; https://clinicaltrials.gov/ct2/show/NCT01734421.",2020,"The continuous abstention level was significantly larger in the intervention group participants who used the app than in those who did not use the app at both 3 months (72/187, 38.5% vs 13/97, 13.4%; P<.001) and 12 months (39/187, 20.9% vs 8/97, 8.25%; P=.01).","['A total of 773 participants were included in the trial, of which 602 (77.9%) began the study on their D-Day', 'smokers older than 18 years who were motivated to stop smoking and used a mobile phone compatible with our mobile app']",[],"['higher probability of not being smokers', 'continuous smoking abstinence', 'continuous abstention level']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439228', 'cui_str': 'day'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",773.0,0.193476,"The continuous abstention level was significantly larger in the intervention group participants who used the app than in those who did not use the app at both 3 months (72/187, 38.5% vs 13/97, 13.4%; P<.001) and 12 months (39/187, 20.9% vs 8/97, 8.25%; P=.01).","[{'ForeName': 'Meritxell', 'Initials': 'M', 'LastName': 'Pallejà-Millán', 'Affiliation': ""Unitat de Suport a la Recerca Camp de Tarragona, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Reus, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Rey-Reñones', 'Affiliation': 'Departament de Ciències Mèdiques Bàsiques, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Barrera Uriarte', 'Affiliation': 'Institut Català de la Salut, Unitat de Suport a la Recerca Camp de Tarragona, Reus, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Granado-Font', 'Affiliation': 'Institut Català de la Salut, Unitat de Suport a la Recerca Camp de Tarragona, Reus, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Basora', 'Affiliation': ""Unitat de Suport a la Recerca Camp de Tarragona, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Reus, Spain.""}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Flores-Mateo', 'Affiliation': ""Unitat de Suport a la Recerca Camp de Tarragona, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Reus, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Duch', 'Affiliation': ""Departament d'Enginyeria Informàtica i Matemàtiques, Universitat Rovira i Virgili, Tarragona, Spain.""}]",JMIR mHealth and uHealth,['10.2196/15951']
983,32591170,"Targeting Cognitive Control Deficits With Neuroplasticity-Based Computerized Cognitive Remediation in Patients With Geriatric Major Depression: A Randomized, Double-Blind, Controlled Trial.","Late life major depression (LLD) is often accompanied by cognitive deficits. When patients have specific deficits in cognitive control functions (CCD), they are not only distressing and debilitating, they often predict poor clinical outcomes such as reduced response to SSRI/SNRI antidepressants, increased disability, suicide and all-cause mortality. We recently reported that in an open label trial, our treatment designed to target these specific CCD with neuroplasticity-based computerized cognitive remediation (nCCR) improved depression and CCD in patients who failed to remit with conventional antidepressant treatment. This study tested the hypothesis that in patients with LLD who have failed at least one trial of an SSRI/SNRI antidepressant at an adequate dose for at least 8 weeks, nCCR will improve both depressive symptoms and the CCD associated with poor antidepressant response (i.e. semantic strategy, inhibition of prepotent responses) more than an active control group. Participants were randomized (1:1) to receive either 30 hours/ 4 weeks of neuroplasticity based computerized cognitive remediation (nCCR) designed to target CCD, or the active control condition matched for duration, engagement, reward, computer presentation, and contact with study staff. All participants and raters were blinded. Mixed effects model analysis the time effect (week) (F(1,71.22)=25.2, p<0.0001) and treatment group X time interaction (F(1,61.8)=11.37, p=.002) reached significance indicating that the slope of decline in MADRS was steeper in the nCCR-GD group. Further, the nCCR group improved their semantic clustering strategy(t(28)=9.5; p=.006), as well as performance on the Stroop interference condition, and cognitive flexibility (Trails B). Further, results transferred to memory performance, which was not a function trained by nCCR. clinicaltrials.gov.",2020,"Further, the nCCR group improved their semantic clustering strategy(t(28)=9.5; p=.006), as well as performance on the Stroop interference condition, and cognitive flexibility (Trails B).","['With Geriatric Major Depression', 'patients who failed to remit with conventional antidepressant treatment', 'patients with LLD who have failed at least one trial of an', 'Patients']","['neuroplasticity-based computerized cognitive remediation (nCCR', '30 hours/ 4 weeks of neuroplasticity based computerized cognitive remediation (nCCR) designed to target CCD, or the active control condition matched for duration, engagement, reward, computer presentation, and contact with study staff', 'Neuroplasticity-Based Computerized Cognitive Remediation', 'SSRI/SNRI antidepressant']","['Stroop interference condition, and cognitive flexibility (Trails B', 'MADRS', 'Late life major depression (LLD']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008928', 'cui_str': 'Cleidocranial dysostosis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C1579361', 'cui_str': 'SSRIs and NRIs'}]","[{'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]",,0.145174,"Further, the nCCR group improved their semantic clustering strategy(t(28)=9.5; p=.006), as well as performance on the Stroop interference condition, and cognitive flexibility (Trails B).","[{'ForeName': 'Sarah Shizuko', 'Initials': 'SS', 'LastName': 'Morimoto', 'Affiliation': 'Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City UT; Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT. Electronic address: sarah.morimoto@hsc.utah.edu.'}, {'ForeName': 'Roger Alan', 'Initials': 'RA', 'LastName': 'Altizer', 'Affiliation': 'Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City UT; Therapeutic Games and Apps Lab, Department of Entertainment Arts and Engineering, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Faith M', 'Initials': 'FM', 'LastName': 'Gunning', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT.'}, {'ForeName': 'Willie', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT.'}, {'ForeName': 'Jiacheng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Zhongda Hospital, Medical School of Southeast University, Nanjing, China.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Cote', 'Affiliation': 'Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City UT.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Nitis', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Alexopoulos', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.05.023']
984,32593895,Effect of administration of β-hydroxy-β-methyl butyrate-enriched formula after liver transplantation: A pilot randomized controlled trial.,"OBJECTIVE


Most patients undergoing liver transplantation (LT) have decreased skeletal muscle mass, malnutrition, and decreased physical activity levels. These comorbidities may prevent early recovery after surgery. The aim of this study was to examine the effects of oral nutritional formula-enriched β-hydroxy-β-methyl-butyrate (HMB), a leucine metabolite that promotes muscle synthesis and suppresses proteolysis, on postoperative sarcopenia and other outcomes after adult-to-adult living donor LT (LDLT).
METHODS


Thirty-three consecutive patients who underwent adult LDLT between March 2017 and October 2018 and who met inclusion criteria were randomly assigned in a 1:1 ratio to the HMB or control group. Patients in the HMB group received two packs of HMB-rich nutrients per day, which contained calcium-HMB (1500 mg), l-arginine (7000 mg), and l -glutamine (7000 mg) per pack orally or enterally from postoperative day 1 to 30 with postoperative rehabilitation. The primary endpoint was grip strength (GS) at 2 mo after LDLT. Secondary endpoints included GS at 1 mo after LDLT, skeletal muscle mass index (SMI) at 1 and 2 mo after LDLT, laboratory findings, incidence of postoperative bacteremia, and postoperative hospital length of stay (LOS).
RESULTS


Twelve patients in the HMB group and 11 in the control group were included in the final analysis. GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04). In the HMB group, white blood cell count 3 wk after LDLT was significantly lower (P = 0.005), and postoperative hospital LOS was significantly shorter (P = 0.028) compared with the control group. The incidence of postoperative bacteremia was lower in the HMB group.
CONCLUSIONS


Postoperative administration of HMB-enriched formula with rehabilitation significantly increased GS at 1 and 2 mo and SMI at 2 mo and shortened postoperative hospital LOS after LDLT.",2020,"GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04).","['patients undergoing liver transplantation (LT', 'after liver transplantation', 'adult-to-adult living donor LT (LDLT', 'Thirty-three consecutive patients who underwent adult LDLT between March 2017 and October 2018 and who met inclusion criteria', 'Twelve patients in the HMB group and 11 in the control group were included in the final analysis']","['HMB', 'oral nutritional formula-enriched β-hydroxy-β-methyl-butyrate (HMB), a leucine metabolite', 'HMB or control group', 'HMB-rich nutrients per day, which contained calcium-HMB (1500 mg), l-arginine (7000 mg), and l -glutamine', 'β-hydroxy-β-methyl butyrate-enriched formula']","['SMI values', 'grip strength (GS', 'white blood cell count', 'incidence of postoperative bacteremia', 'postoperative hospital LOS', 'GS at 1 mo after LDLT, skeletal muscle mass index (SMI) at 1 and 2 mo after LDLT, laboratory findings, incidence of postoperative bacteremia, and postoperative hospital length of stay (LOS', 'GS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0066231', 'cui_str': 'Methyl butyrate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0066231', 'cui_str': 'Methyl butyrate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C4708914', 'cui_str': '7000'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]","[{'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",33.0,0.0731392,"GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04).","[{'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kamo', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Kaido', 'Affiliation': ""Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Department of Gastroenterological and General Surgery, St Luke's International University and Hospital, Tokyo, Japan. Electronic address: kaido@kuhp.kyoto-u.ac.jp.""}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Uozumi', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Yagi', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Hata', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Taura', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Uemoto', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110871']
985,32600949,A nomogram for prediction of distant metastasis in children with wilms tumor: A study based on SEER database.,"INTRODUCTION


Accurate diagnosis of distant metastasis especially uncommon site of metastasis (UCM) in patients with Wilms tumor (WTs) is a demanding prerequisite for administration of appropriate therapy and achieving better survival outcome.
OBJECTIVE


To develop and validate a nomogram to predict probability of distant metastasis, and identify population demanded for rigorous imaging evaluations in children with WTs.
MATERIAL AND METHODS


Data of patients diagnosed with unilateral WTs and aged under 18 years old, were extracted from the Surveillance, Epidemiology, and End Results (SEER) database. The included patients were randomly allocated to the training and the validation cohort. Logistic regression analyses were performed to identify the independent risk factors and develop a predicting model of distant metastasis in WTs. The model-based nomogram was created and internally validated. Cut-off value of nomogram points was derived by using the receiver operating characteristics (ROC) curve analysis. Performance of the nomogram was evaluated in terms of discrimination, calibration and clinical usefulness.
RESULTS


A total 717 WTs patients were included in the study. Age at diagnosis (OR 1.173, 95%CI: 1.079-1.279), LND (OR 8.260, 95%CI: 2.837-24.814) and tumor size (OR 2.141, 95%CI: 1.378-3.329) were identified as the independent risk factors of distant metastasis in WTs. These three factors were incorporated to develop a model and a nomogram. The nomogram presented with good discriminative ability in the training cohort (C-statistics, 0.703) and validation cohort (C-statistics, 0.764), respectively. The calibration curves demonstrated adequate agreement between predicted probability and observed probability of distant metastasis. The nomogram also revealed its clinical usefulness by application of decision curve analysis (DCA). Cut-off value of nomogram points was 58 and its corresponding probability of distant metastasis was 0.22. The value was applied in risk stratification dividing the general cohort into high-risk and low-risk group.
DISCUSSION


Our study for the first time developed and validated a model and a visualized nomogram for individualized prediction of distant metastasis in WTs. C-statistics, calibration curves and DCA demonstrated good performance and clinical usefulness of the nomogram. Patients stratified as high-risk group were demanded for rigorous imaging evaluations to accurately identify UCM.
CONCLUSION


The nomogram, developed by incorporation of three independent risk factors, which are age at diagnosis, LND and tumor size, is used to facilitate individualized prediction of distant metastasis in WTs. Rigorous imaging evaluations are recommended for patients in high-risk group to identify UCM.",2020,"The nomogram presented with good discriminative ability in the training cohort (C-statistics, 0.703) and validation cohort (C-statistics, 0.764), respectively.","['children with wilms tumor', 'children with WTs', 'A total 717 WTs patients were included in the study', 'Data of patients diagnosed with unilateral WTs and aged under 18 years old, were extracted from the Surveillance, Epidemiology, and End Results (SEER) database', 'patients in high-risk group to identify UCM', 'patients with Wilms tumor (WTs']",[],['tumor size '],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027708', 'cui_str': 'Nephroblastoma'}, {'cui': 'C1839736', 'cui_str': 'Wilson-Turner X-linked mental retardation syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0522498', 'cui_str': 'Rare'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",[],"[{'cui': 'C0475440', 'cui_str': 'Tumor size'}]",717.0,0.03782,"The nomogram presented with good discriminative ability in the training cohort (C-statistics, 0.703) and validation cohort (C-statistics, 0.764), respectively.","[{'ForeName': 'Yangyue', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Pediatric Urology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, 100045, China.""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Pediatric Urology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, 100045, China.""}, {'ForeName': 'Hongcheng', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': ""Department of Pediatric Urology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, 100045, China.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Sun', 'Affiliation': ""Department of Pediatric Urology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, 100045, China. Electronic address: drsunningbch@sina.com.""}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.05.158']
986,32608989,Integrated Yoga Practice in Cardiac Rehabilitation Program: A Randomized Control Trial.,"Background:  Coronary artery disease (CAD) is a detrimental noncommunicable disease, which is increasing due to sedentary lifestyle and urbanization in the young population. It is further elevated with risk factors such as stress, anxiety, depression, an increase in triglycerides, dyslipidemia, hyperglycemia, hypertension, and so on, which manifests as atherosclerotic disease. Yoga-based lifestyle intervention is a noninvasive effective treatment method to control and prevent cardiac risk factors in CAD patients. Yoga has been used in India as a therapeutic method to manage hypertension and other chronic disorders and is fast gaining popularity as an effective means for the alleviation of stress, improvement of fitness, and enhancement of well-being. This study aimed to determine the feasibility of introducing the integrated approach of yoga therapy (IAYT) in a cardiac rehabilitation center in India and understand its usefulness in improving the cardiac function and managing the cardiac risk factors in acute myocardial infarction patients with left ventricular dysfunction.  Methods and Design:  Cardiac patients were randomized to a yoga-practicing group ( n  = 33) and a control group ( n  = 33). The yoga-practicing group was instructed to attend three supervised IAYT classes 3 days per week for 12 weeks at the hospital yoga center. The control group received standard care that included pharmacologic treatment and the instructions of the cardiologist. The outcome measures were assessed at baseline (T1 = 0) and completion (T2 = 3 months). The primary outcome measure was the left ventricular ejection fraction (LVEF).  Results:  There was no statistically significant difference in LVEF ( U  = 420.500,  p  value = 0.218) between the two groups. However, the yoga-practicing group showed significant reduction in depression (Cardiac Depression Scale [CDS],  U  = 71,  p  value = 0.0), anxiety (Hamilton Anxiety Rating Scale [HAM-A],  U  = 128,  p  value = 0.0), and a significant increase in quality of life (QOL) scores (Duke Activity Status Index [DASI],  U  = 146,  p  value = 0.0; and metabolic equivalents (METs),  U  = 136,  p  value = 0.0) at 3 months compared to control. Overall, the CAD patients practicing yoga showed a favorable profile compared to control individuals on CDS, HAM-A, DASI, and MET outcomes. Control and yoga practicing groups did not differ significantly in the lipid levels.  Conclusion:  This study indicated that the integration of yoga practice in a cardiac rehabilitation program is feasible and has no added benefit in improving the cardiac function. However, the addition of yoga to cardiac rehabilitation may be beneficial in reducing depression and anxiety and improving QOL in patients.",2020,"There was no statistically significant difference in LVEF ( U  = 420.500,  p  value = 0.218) between the two groups.","['Cardiac Rehabilitation Program', 'acute myocardial infarction patients with left ventricular dysfunction', 'CAD patients']","['Yoga-based lifestyle intervention', 'yoga-practicing group', 'standard care that included pharmacologic treatment and the instructions of the cardiologist', 'yoga therapy (IAYT']","['LVEF', 'CDS, HAM-A, DASI, and MET outcomes', 'quality of life (QOL) scores (Duke Activity Status Index [DASI', 'depression and anxiety and improving QOL', 'cardiac risk factors', 'left ventricular ejection fraction (LVEF', 'triglycerides, dyslipidemia, hyperglycemia, hypertension', 'depression (Cardiac Depression Scale [CDS],  U \u2009=\u200971,  p  value\u2009=\u20090.0), anxiety (Hamilton Anxiety Rating Scale', 'lipid levels']","[{'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242973', 'cui_str': 'Ventricular dysfunction'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0175906', 'cui_str': 'Cardiologist'}]","[{'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4720913', 'cui_str': 'Duke activity status index'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}]",,0.0233143,"There was no statistically significant difference in LVEF ( U  = 420.500,  p  value = 0.218) between the two groups.","[{'ForeName': 'K N Srihari', 'Initials': 'KNS', 'LastName': 'Sharma', 'Affiliation': 'Division of Yoga and Life Sciences, Swami Vivekananda Yoga University (SVYASA), Bangalore, India.'}, {'ForeName': 'Subramanya', 'Initials': 'S', 'LastName': 'Pailoor', 'Affiliation': 'Division of Yoga and Life Sciences, Swami Vivekananda Yoga University (SVYASA), Bangalore, India.'}, {'ForeName': 'Nidhi Ram', 'Initials': 'NR', 'LastName': 'Choudhary', 'Affiliation': 'Division of Yoga and Life Sciences, Swami Vivekananda Yoga University (SVYASA), Bangalore, India.'}, {'ForeName': 'Prabhavathi', 'Initials': 'P', 'LastName': 'Bhat', 'Affiliation': 'Department of Cardiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore, India.'}, {'ForeName': 'Smeeta', 'Initials': 'S', 'LastName': 'Shrestha', 'Affiliation': 'School of Basic and Applied Sciences, Dayananda Sagar University, Bangalore, India.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0250']
987,32609001,Examining Identity Shift Effects in Virtual Reality.,"Identity shift describes how individuals commit to self-presentations made in public computer-mediated contexts. This study attempts to expand identity shift effects to virtual reality. Participants were randomly assigned to present themselves as extraverted or introverted in pilot tested public or private virtual environments. The hypotheses and data analysis strategy were preregistered, and the study had sufficient  a priori  statistical power. The results did not support identity shift effects. Baseline extraversion predicted postmanipulation extraversion scores, thus suggesting identity stability. The discussion focuses on the empirical consistency of the identity shift effect and avenues for future research.",2020,Participants were randomly assigned to present themselves as extraverted or introverted in pilot tested public or private virtual environments.,[],['extraverted or introverted in pilot tested public or private virtual environments'],[],[],"[{'cui': 'C0557871', 'cui_str': 'Extrovert'}, {'cui': 'C0557869', 'cui_str': 'Introvert'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]",[],,0.0168884,Participants were randomly assigned to present themselves as extraverted or introverted in pilot tested public or private virtual environments.,"[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Peña', 'Affiliation': 'University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Dillon', 'Initials': 'D', 'LastName': 'Hill', 'Affiliation': 'University of California, Davis, Davis, California, USA.'}]","Cyberpsychology, behavior and social networking",['10.1089/cyber.2020.0010']
988,32615237,Influence of different clinical criteria on the decision to replace restorations in primary teeth.,"OBJECTIVES


This cross-sectional study is nested in a randomized clinical trial. It was designed to evaluate the influence of using two different clinical criteria to assess caries lesion around restorations on the decision to replace restorations in primary posterior teeth. Variables that might influence this decision were also considered.
METHODS


One trained and calibrated examiner assessed 550 restorations of 160 children (3-10 years old). Children were randomized to have their restorations evaluated and subsequently treated according to World Dental Federation (FDI) or Caries Associated with Restorations and Sealants (CARS) criteria. After reaching the treatment decision, the same examiner performed another evaluation using the other criteria. Spearman's correlation coefficients and 95 % confidence intervals (95 %CI) between the scores obtained with both criteria and respective treatment decisions were calculated. Poisson multilevel regression analysis were performed between the exploratory variables related to children, restored tooth and restoration assessment; the outcome variables were decisions related to restoration replacement, any operative intervention and presence of secondary caries.
RESULTS


The strongest correlation observed between the methods was for recurrence of caries. A total of 94 restorations (17.1 %) were indicated for replacement with FDI criteria and 30 (5.5 %) were indicated for replacement with CARS. Besides the diagnostic method used, number of decayed teeth and restorations with two and three restored surfaces were associated with the decision of replacement and presence of recurrent caries lesions.
CONCLUSIONS


The decision to replace posterior restorations in primary teeth is influenced by the criteria used for the restorations assessment and also by the children's caries experience and multisurface restorations. The restoration material did not influence the decision of restorations replacement.
CLINICAL SIGNIFICANCE


The decision to replace posterior restoration in primary teeth is strongly related to the evaluation method and not only by patients' risk factors.",2020,"Besides the diagnostic method used, number of decayed teeth and restorations with two and three restored surfaces were associated with the decision of replacement and presence of recurrent caries lesions.
","['One trained and calibrated examiner assessed 550 restorations of 160 children (3-10 years old', 'Children were randomized to have their restorations evaluated and subsequently treated according to World Dental Federation (FDI) or Caries Associated with Restorations and Sealants (CARS) criteria', 'primary posterior teeth', 'primary teeth']",[],"['operative intervention and presence of secondary caries', 'recurrence of caries']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}]",[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1882989', 'cui_str': 'Secondary caries'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]",160.0,0.0402393,"Besides the diagnostic method used, number of decayed teeth and restorations with two and three restored surfaces were associated with the decision of replacement and presence of recurrent caries lesions.
","[{'ForeName': 'Bruna Lorena Pereira', 'Initials': 'BLP', 'LastName': 'Moro', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: bruna.moro@usp.br.'}, {'ForeName': 'Raiza Dias', 'Initials': 'RD', 'LastName': 'Freitas', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: raizafreitas@usp.br.'}, {'ForeName': 'Laura Regina Antunes', 'Initials': 'LRA', 'LastName': 'Pontes', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: laura.pontes@usp.br.'}, {'ForeName': 'Ana Laura', 'Initials': 'AL', 'LastName': 'Pássaro', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: ana.passaro@usp.br.'}, {'ForeName': 'Tathiane Larissa', 'Initials': 'TL', 'LastName': 'Lenzi', 'Affiliation': 'School of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil. Electronic address: tathiane.lenzi@ufrgs.br.'}, {'ForeName': 'Tamara Kerber', 'Initials': 'TK', 'LastName': 'Tedesco', 'Affiliation': 'Graduation Program in Dentistry, Ibirapuera University, São Paulo, Brazil. Electronic address: tamarakt@usp.br.'}, {'ForeName': 'Kim Rud', 'Initials': 'KR', 'LastName': 'Ekstrand', 'Affiliation': 'Section of Cariology and Endodontics, University of Copenhagen, Copenhagen, Denmark. Electronic address: kek@sund.ku.dk.'}, {'ForeName': 'Mariana Minatel', 'Initials': 'MM', 'LastName': 'Braga', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: mmbraga@usp.br.'}, {'ForeName': 'Daniela Prócida', 'Initials': 'DP', 'LastName': 'Raggio', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: danielar@usp.br.'}, {'ForeName': 'Maximiliano Sérgio', 'Initials': 'MS', 'LastName': 'Cenci', 'Affiliation': 'Federal University of Pelotas, Graduate Program in Dentistry, Pelotas, Rio Grande do Sul, Brazil. Electronic address: maximiliano.cenci@ufpel.edu.br.'}, {'ForeName': 'Fausto Medeiros', 'Initials': 'FM', 'LastName': 'Mendes', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: fmmendes@usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103421']
989,32619792,Human urine  1 H NMR metabolomics reveals alterations of the protein and carbohydrate metabolism when comparing habitual Average Danish diet vs. healthy New Nordic diet.,"OBJECTIVES


The aim of this study was to investigate the alteration of the human urine metabolome by means of diet and to compare the metabolic effects of the nutritionally healthy New Nordic Diet (NND) with an Average Danish Diet (ADD). The NND was designed a decade ago by scientists and chefs, based on local and sustainable foods, including fish, shellfish, vegetables, roots, fruit, and berries. The NND has been proven to lower blood pressure, reduce glycemia, and lead to weight loss.
METHODS


The human urine metabolome was measured by untargeted proton nuclear magnetic resonance spectroscopy in samples from 142 centrally obese Danes (20-66 years old), randomized to consume the ADD or the NND. The resulting metabolomics data was processed and analyzed using advanced multivariate data analysis methods to reveal effects related to the design factors, including diet, season, sex, and changes in body weight.
RESULTS


Exploration of the nuclear magnetic resonance profiles revealed unique metabolite markers reflecting changes in protein and carbohydrate metabolism between the two diets. Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased. Propylene glycol had a strong association with the homeostatic model assessment for insulin resistance in the NND group. The food intake biomarkers found in this study confirm the importance of these as tools for nutritional research.
CONCLUSIONS


Findings from this study provided new insights into the effects of a healthy diet on glycemia, reduction of inflammation, and weight loss among obese individuals, and alteration of the gut microbiota metabolism.",2020,"Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased.",['in samples from 142 centrally obese Danes (20-66 years old'],"['nutritionally healthy New Nordic Diet (NND) with an Average Danish Diet (ADD', 'Propylene glycol', 'untargeted proton nuclear magnetic resonance spectroscopy']","['relative concentrations of tartrate, dimethyl sulfone, and propylene glycol', 'glycemia, reduction of inflammation, and weight loss', 'Glycine betaine, glucose, trimethylamine N-oxide and creatinine']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0337800', 'cui_str': 'Danes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0877853', 'cui_str': 'Spectroscopy, NMR'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039328', 'cui_str': 'Tartrates'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",142.0,0.027383,"Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased.","[{'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Trimigno', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bekzod', 'Initials': 'B', 'LastName': 'Khakimov', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Savorani', 'Affiliation': 'Department of Applied Science and Technology, Polytechnic of Turin, Turin, Italy.'}, {'ForeName': 'Sanne Kellebjerg', 'Initials': 'SK', 'LastName': 'Poulsen', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars O', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Søren Balling', 'Initials': 'SB', 'LastName': 'Engelsen', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark. Electronic address: se@food.ku.dk.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110867']
990,32620866,Spa therapy with physical rehabilitation is an alternative to usual spa therapy protocol in symptomatic knee osteoarthritis.,"The objective of the study was to demonstrate the non-inferiority of low-frequency spa therapy combined with rehabilitation (Spa-rehab) versus standard spa therapy at 6 months for symptomatic knee osteoarthritis (KOA). A prospective, randomized, monocenter, non-inferiority trial with recruitment of community-based symptomatic KOA patients was performed. Standard spa therapy comprised standardized spa treatment, 6 days a week for 3 weeks, and Spa-rehab therapy comprised spa sessions, 3 days a week for 3 weeks, followed by a dedicated rehabilitation program, 3 days a week for 3 weeks. The primary endpoint was achieving at 6 months a minimal clinically important improvement (MCII) for pain on a visual analog scale and/or an MCII for function on the WOMAC index and no knee surgery (composite MCII). Secondary endpoints were composite MCII at 3 months and achieving a Patient Acceptable Symptom State (PASS) for pain and function at 3 and 6 months. Among 283 patients included, 145 were allocated to standard spa therapy and 138 to Spa-rehab therapy. We could not demonstrate the non-inferiority of Spa-rehab therapy for the primary endpoint: difference for responders - 0.08 [90% CI (- 0.18 to 0.02), p = 0.14]. However, the difference test between the groups was not significant (p = 0.18). Spa-rehab therapy was not inferior to standard spa therapy for the composite MCII at 3 months or the PASS at 3 and 6 months. Spa-rehab therapy can reasonably be proposed to patients with symptomatic KOA. This protocol may be more cost-effective than standard spa therapy and avoid absenteeism from work and accommodation costs for patients who live close to a centre.",2020,Spa-rehab therapy was not inferior to standard spa therapy for the composite MCII at 3 months or the PASS at 3 and 6 months.,"['patients with symptomatic KOA', 'symptomatic knee osteoarthritis (KOA', '283 patients included, 145 were allocated to', 'patients who live close to a centre', 'symptomatic knee osteoarthritis']","['Spa therapy with physical rehabilitation', 'Spa-rehab therapy', 'standard spa therapy', 'low-frequency spa therapy combined with rehabilitation (Spa-rehab) versus standard spa therapy']","['achieving at 6\xa0months a minimal clinically important improvement (MCII) for pain on a visual analog scale and/or an MCII for function on the WOMAC index and no knee surgery (composite MCII', 'composite MCII at 3\xa0months and achieving a Patient Acceptable Symptom State (PASS) for pain and function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}]",283.0,0.040187,Spa-rehab therapy was not inferior to standard spa therapy for the composite MCII at 3 months or the PASS at 3 and 6 months.,"[{'ForeName': 'Anne-Christine', 'Initials': 'AC', 'LastName': 'Rat', 'Affiliation': 'EA 4360 APEMAC, Université de Lorraine, 54500, Nancy, France. rat-ac@chu-caen.fr.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Loeuille', 'Affiliation': 'Department of Rheumatology, Nancy University Hospital, 54511, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Vallata', 'Affiliation': 'EA 4360 APEMAC, Université de Lorraine, 54500, Nancy, France.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Bernard', 'Affiliation': 'Inserm CIC-EC 1433, Nancy, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Spitz', 'Affiliation': 'Department of Rheumatology, Nancy University Hospital, 54511, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Desvignes', 'Affiliation': 'Department of Rheumatology, Nancy University Hospital, 54511, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Boulange', 'Affiliation': 'Université de Lorraine, Nancy, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Paysant', 'Affiliation': 'Regional Institute for Physical and Rehabilitation Medicine-Louis Pierquin Center of Nancy, 54500, Nancy, France.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Guillemin', 'Affiliation': 'EA 4360 APEMAC, Université de Lorraine, 54500, Nancy, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chary-Valckenaere', 'Affiliation': 'Department of Rheumatology, Nancy University Hospital, 54511, Vandoeuvre-les-Nancy, France.'}]",Scientific reports,['10.1038/s41598-020-67436-1']
991,32623487,A single dose of zoledronate preserves bone mineral density for up to 2 years after a second course of romosozumab.,"This phase 2 study evaluated the efficacy and safety of transitioning to zoledronate following romosozumab treatment in postmenopausal women with low bone mass. A single dose of 5 mg zoledronate generally maintained the robust BMD gains accrued with romosozumab treatment and was well tolerated.
INTRODUCTION


Follow-on therapy with an antiresorptive agent is necessary to maintain the skeletal benefits of romosozumab therapy. We evaluated the use of zoledronate following romosozumab treatment.
METHODS


This phase 2, dose-finding study enrolled postmenopausal women with low bone mineral density (BMD). Subjects who received various romosozumab doses or placebo from months 0-24 were rerandomized to denosumab (60 mg SC Q6M) or placebo for 12 months, followed by open-label romosozumab (210 mg QM) for 12 months. At month 48, subjects who had received active treatment for 48 months were assigned to no further active treatment and all other subjects were assigned to zoledronate 5 mg IV. Efficacy (BMD, P1NP, and β-CTX) and safety were evaluated for 24 months, up to month 72.
RESULTS


A total of 141 subjects entered the month 48-72 period, with 51 in the no further active treatment group and 90 in the zoledronate group. In subjects receiving no further active treatment, lumbar spine (LS) BMD decreased by 10.8% from months 48-72 but remained 4.2% above the original baseline. In subjects receiving zoledronate, LS BMD was maintained (percentage changes: - 0.8% from months 48-72; 12.8% from months 0-72). Similar patterns were observed for proximal femur BMD in both groups. With no further active treatment, P1NP and β-CTX decreased but remained above baseline at month 72. Following zoledronate, P1NP and β-CTX levels initially decreased but approached baseline by month 72. No new safety signals were observed.
CONCLUSION


A zoledronate follow-on regimen can maintain robust BMD gains achieved with romosozumab treatment.",2020,"Following zoledronate, P1NP and β-CTX levels initially decreased but approached baseline by month 72.","['141 subjects entered the month 48-72 period, with 51 in the no further active treatment group and 90 in the zoledronate group', 'postmenopausal women with low bone mass', 'enrolled postmenopausal women with low bone mineral density (BMD', 'At month 48, subjects who had received active treatment for 48\xa0months']","['zoledronate 5\xa0mg IV', 'romosozumab treatment', 'various romosozumab doses or placebo', 'denosumab', 'zoledronate', 'placebo']","['bone mineral density', 'proximal femur BMD', 'P1NP and β-CTX', 'β-CTX levels', 'tolerated', 'BMD gains', 'efficacy and safety', 'Efficacy (BMD, P1NP, and β-CTX) and safety', 'LS BMD', 'lumbar spine (LS) BMD']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]","[{'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C3661283', 'cui_str': 'romosozumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",141.0,0.0281302,"Following zoledronate, P1NP and β-CTX levels initially decreased but approached baseline by month 72.","[{'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'McClung', 'Affiliation': 'Oregon Osteoporosis Center, 2881 NW Cumberland Road, Portland, OR 97210, USA. mmcclung.ooc@gmail.com.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Bolognese', 'Affiliation': 'Bethesda Health Research Center, Bethesda, MD, USA.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Brown', 'Affiliation': 'Laval University and CHU de Québec (CHUL) Research Centre, Québec City, QC, Canada.'}, {'ForeName': 'J-Y', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'University of Liège, Liège, Belgium.'}, {'ForeName': 'B L', 'Initials': 'BL', 'LastName': 'Langdahl', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Maddox', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rojeski', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Meisner', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Grauer', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05502-0']
992,32623510,"Bencycloquidium bromide nasal spray is effective and safe for persistent allergic rhinitis: a phase III, multicenter, randomized, double-blinded, placebo-controlled clinical trial.","PURPOSE


To investigate the efficacy and safety of bencycloquidium bromide nasal spray (BCQB) in patients with persistent allergic rhinitis (PAR).
METHODS


We enrolled 720 patients from 15 hospitals across China and randomly assigned them into BCQB group or placebo group (90 μg per nostril qid) to receive a 4-week treatment. Visual analog scale (VAS) for rhinorrhea, sneezing, nasal congestion, itching and overall symptoms were recorded by patients every day. Anterior rhinoscopy scoring was completed by doctors on every visit. Adverse events were recorded in detail.
RESULTS


A total of 354 and 351 patients were included in BCQB group and in placebo group. Baseline information was comparable. At the end of the trial, the decrease of VAS for rhinorrhea from baseline was 4.83 ± 2.35 and 2.46 ± 2.34 in BCQB group and placebo group, respectively (P < 0.001). The change ratio from baseline of VAS for rhinorrhea in BCQB group was 72.32%, higher than 31.03% in placebo group (P < 0.001). VAS for other symptoms and overall symptoms also improved significantly in the BCQB group, while no inter-group difference was found in anterior rhinoscopy scoring. The incidence of adverse reaction was similar between the two groups. Most reactions were mild and no severe reactions happened.
CONCLUSION


90 μg BCQB per nostril four times daily is effective and safe in the treatment of rhinorrhea as well as sneezing, nasal congestion and itching for patients with PAR.
RETROSPECTIVELY REGISTERED


ChiCTR2000030924, 2020/3/17.",2020,"Visual analog scale (VAS) for rhinorrhea, sneezing, nasal congestion, itching and overall symptoms were recorded by patients every day.","['A total of 354 and 351 patients were included in BCQB group and in placebo group', 'persistent allergic rhinitis', 'patients with PAR', '720 patients from 15 hospitals across China and randomly assigned them into', 'patients with persistent allergic rhinitis (PAR']","['BCQB', 'VAS', 'Bencycloquidium bromide nasal spray', 'BCQB group or placebo', 'bencycloquidium bromide nasal spray (BCQB', 'placebo']","['change ratio from baseline of VAS for rhinorrhea', 'Adverse events', 'VAS for rhinorrhea', 'incidence of adverse reaction', 'Visual analog scale (VAS) for rhinorrhea, sneezing, nasal congestion, itching and overall symptoms']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1870334', 'cui_str': 'bencycloquidium bromide'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332286', 'cui_str': 'Into'}]","[{'cui': 'C1870334', 'cui_str': 'bencycloquidium bromide'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0037383', 'cui_str': 'Sneezing'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",720.0,0.566384,"Visual analog scale (VAS) for rhinorrhea, sneezing, nasal congestion, itching and overall symptoms were recorded by patients every day.","[{'ForeName': 'Zihan', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': ""Department of Otorhinolaryngology, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': ""Department of Otorhinolaryngology, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Shixi', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Otorhinolaryngology, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'He', 'Affiliation': ""Department of Otorhinolaryngology, Sichuan Provincial People's Hospital, Chengdu, 610072, People's Republic of China.""}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': ""Department of Otolaryngology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, People's Republic of China.""}, {'ForeName': 'Xueyuan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Otolaryngology, Southwest Hospital, Army Medical University, 30 Gaotan Yan St, Chongqing, 400038, People's Republic of China.""}, {'ForeName': 'Qinna', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Otorhinolaryngology Head and Neck Surgery, First Hospital of Shanxi Medical University, Taiyuan, 030001, People's Republic of China.""}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Otorhinolaryngology, Daping Hospital, Army Medical University, Chongqing, 400042, People's Republic of China.""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': ""Department of Otolaryngology, The First Affiliated Hospital, Fujian Medical University, Fuzhou, 350005, People's Republic of China.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': ""Department of Otolaryngology, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, 530021, People's Republic of China.""}, {'ForeName': 'Mingli', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': ""Department of Otorhinolaryngology, Hebei General Hospital, Shijiazhuang, Hebei, 050051, People's Republic of China.""}, {'ForeName': 'Xuping', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': ""Department of Otorhinolaryngology Head and Neck Surgery, Hunan Provincial People's Hospital, Changsha, 410005, People's Republic of China.""}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': ""Department of Otolaryngology, Qingdao Municipal Hospital, Qingdao, Shandong, 266011, People's Republic of China.""}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Dong', 'Affiliation': ""Department of Otorhinolaryngology Head and Neck Surgery, Shanghai General Hospital, College of Medicine, Shanghai Jiao Tong University, Shanghai, 200080, People's Republic of China.""}, {'ForeName': 'Yongwang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Otolaryngology, The Second Hospital of Tianjin Medical University, Tianjin, 300211, People's Republic of China.""}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Lian', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery, The First People's Hospital, Yangzhou, 225001, People's Republic of China.""}, {'ForeName': 'Guolin', 'Initials': 'G', 'LastName': 'Tan', 'Affiliation': ""Department of Otorhinolaryngology Head and Neck Surgery, Third Xiangya Hospital, Central South University, Changsha, 410013, People's Republic of China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Department of Health, Statistics, Faculty of Medical Service, Second Military Medical University, Shanghai, 200433, People's Republic of China.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ""Yingu Pharmaceutical Co., Ltd, Beijing, 100190, People's Republic of China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Meng', 'Affiliation': ""Department of Otorhinolaryngology, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu, 610041, People's Republic of China. mjmelinda@163.com.""}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06183-5']
993,32632643,The Impact of Surgical Boot Camp and Subsequent Repetitive Practice on the Surgical Skills and Confidence of Residents.,"BACKGROUND


Boot camp can enable residents to acquire surgical skills and confidence, but they can lose these skills over time if they do not use them. The purpose of this study was to explore whether boot camp and subsequent repetitive practice could strengthen residents' clinical skills and self-confidence.
METHODS


This is a comparative study of surgical residents who were enrolled in our institution from 2016 to 2017. The residents in the experimental group (enrolled in 2017) received boot camp training and a year of repetitive practice. The control group (enrolled in 2016) only received routine residency training. The rotation assessment pass rates of the two groups during the first year of the residency training were compared. A survey was conducted at different points in time to investigate the influence of boot camp and repetitive practice on the confidence of the residents.
RESULTS


The assessment pass rate of the experimental group was significantly higher than that of the control group (p < 0.05). The residents' confidence in themselves improved significantly after the boot camp, and it was comparable to that of the residents in the control group after their first year of residency. The level of self-confidence of the experimental group was further improved after repetitive practice. Finally, residents in the experimental group received better evaluations by their colleagues than the control group received.
CONCLUSIONS


This study showed that boot camp can improve the surgical skills and confidence of residents and that repetitive practice can further strengthen them. Residents in the experimental group developed their self-confidence in boot camp, and it increased after repetitive practice.",2020,The assessment pass rate of the experimental group was significantly higher than that of the control group (p < 0.05).,"['surgical residents who were enrolled in our institution from 2016 to 2017', 'Residents']","['boot camp and subsequent repetitive practice', 'boot camp training', 'routine residency training', 'Surgical Boot Camp and Subsequent Repetitive Practice']","['level of self-confidence', 'rotation assessment pass rates', 'self-confidence', 'assessment pass rate']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0729274', 'cui_str': 'Boots - surgical'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0270523,The assessment pass rate of the experimental group was significantly higher than that of the control group (p < 0.05).,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, No. 321 Zhongshan Road, Nanjing, 210008, Jiangsu, People's Republic of China.""}, {'ForeName': 'Hucheng', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': ""Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, No. 321 Zhongshan Road, Nanjing, 210008, Jiangsu, People's Republic of China.""}, {'ForeName': 'Haozhen', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': ""Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, No. 321 Zhongshan Road, Nanjing, 210008, Jiangsu, People's Republic of China.""}, {'ForeName': 'Zhongxia', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, No. 321 Zhongshan Road, Nanjing, 210008, Jiangsu, People's Republic of China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Mao', 'Affiliation': ""Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, No. 321 Zhongshan Road, Nanjing, 210008, Jiangsu, People's Republic of China.""}, {'ForeName': 'Ningning', 'Initials': 'N', 'LastName': 'He', 'Affiliation': ""Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, No. 321 Zhongshan Road, Nanjing, 210008, Jiangsu, People's Republic of China. 2015455752@qq.com.""}]",World journal of surgery,['10.1007/s00268-020-05669-x']
994,32639518,Effect of C-Reactive Protein on Lipoprotein(a)-Associated Cardiovascular Risk in Optimally Treated Patients With High-Risk Vascular Disease: A Prespecified Secondary Analysis of the ACCELERATE Trial.,"Importance


Although lipoprotein(a) (Lp[a]) is a causal genetic risk factor for atherosclerotic cardiovascular disease, it remains unclear which patients with established atherosclerotic cardiovascular disease stand to benefit the most from Lp(a) lowering. Whether inflammation can modulate Lp(a)-associated cardiovascular (CV) risk during secondary prevention is unknown.
Objective


To examine whether Lp(a)-associated CV risk is modulated by systemic inflammation in optimally treated patients at high risk of CV disease.
Design, Setting, and Participants


A prespecified secondary post hoc analysis of the double-blind, multicenter randomized clinical Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High Risk for Vascular Outcomes (ACCELERATE) trial was conducted between October 1, 2012, and December 31, 2013; the study was terminated October 12, 2015. The study was conducted at 543 academic and community hospitals in 36 countries among 12 092 patients at high risk of CV disease (acute coronary syndrome, stroke, peripheral arterial disease, or type 2 diabetes with coronary artery disease) with measurable Lp(a) and high-sensitivity C-reactive protein (hsCRP) levels during treatment. Statistical analysis for this post hoc analysis was performed from September 26, 2018, to March 28, 2020.
Interventions


Participants received evacetrapib, 130 mg/d, or matching placebo.
Main Outcomes and Measures


The ACCELERATE trial found no significant benefit or harm of evacetrapib on 30-month major adverse cardiovascular events (CV death, myocardial infarction [MI], stroke, coronary revascularization, or hospitalization for unstable angina). This secondary analysis evaluated rates of CV death, MI, and stroke across levels of Lp(a).
Results


High-sensitivity C-reactive protein and Lp(a) levels were measured in 10 503 patients (8135 men; 8561 white; 10 134 received concurrent statins; mean [SD] age, 64.6 [9.4] years). In fully adjusted analyses, in patients with hsCRP of 2 mg/L or more but not less than 2 mg/L, increasing quintiles of Lp(a) were significantly associated with greater rates of death, MI, and stroke (P = .006 for interaction). Each unit increase in log Lp(a) levels was associated with a 13% increased risk of CV death, nonfatal MI, or stroke only in those with hsCRP levels of 2 mg/L or more (P = .008 for interaction). There was also a significant stepwise relationship between increasing Lp(a) quintiles and time to first CV death, MI, or stroke (log-rank P < .001) when hsCRP levels were 2 mg/L or more but not less than 2 mg/L. Sensitivity analyses in the ACCELERATE placebo-treated group yielded similar significant associations exclusively in the group with hsCRP of 2 mg/L or more.
Conclusions and Relevance


Elevated Lp(a) levels during treatment are related to CV death, MI, and stroke when hsCRP levels are 2 mg/L or more but not less than 2mg/L. This finding suggests a potential benefit of lowering Lp(a) in patients with residual systemic inflammation despite receipt of optimal medical therapy.
Trial Registration


ClinicalTrials.gov Identifier: NCT01687998.",2020,".001) when hsCRP levels were 2 mg/L or more but not less than 2 mg/L. Sensitivity analyses in the ACCELERATE placebo-treated group yielded similar significant associations exclusively in the group with hsCRP of 2 mg/L or more.
","['Optimally Treated Patients With High-Risk Vascular Disease', '10 503 patients (8135 men; 8561 white; 10 134 received concurrent statins; mean [SD] age, 64.6 [9.4] years', 'Patients at a High Risk for Vascular Outcomes (ACCELERATE) trial was conducted between October 1, 2012, and December 31, 2013; the study was terminated October 12, 2015', '543 academic and community hospitals in 36 countries among 12 092 patients at high risk of CV disease (acute coronary syndrome, stroke, peripheral arterial disease, or type 2 diabetes with coronary artery disease) with measurable Lp(a) and high-sensitivity C-reactive protein (hsCRP) levels during treatment', 'patients with residual systemic inflammation despite receipt of optimal medical therapy', 'optimally treated patients at high risk of CV disease', 'patients with established atherosclerotic cardiovascular disease']","['C-Reactive Protein', 'lipoprotein(a) (Lp[a', 'Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib', 'evacetrapib, 130 mg/d, or matching placebo']","['30-month major adverse cardiovascular events (CV death, myocardial infarction [MI], stroke, coronary revascularization, or hospitalization for unstable angina', 'quintiles of Lp(a', 'hsCRP levels', 'Lipoprotein(a)-Associated Cardiovascular Risk', 'log Lp(a', 'High-sensitivity C-reactive protein and Lp(a) levels', 'rates of CV death, MI, and stroke across levels of Lp(a', 'Lp(a) quintiles and time to first CV death, MI, or stroke (log-rank P\u2009', 'rates of death, MI, and stroke', 'risk of CV death, nonfatal MI, or stroke']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0055538', 'cui_str': 'Cholesterol ester transfer protein'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C3252279', 'cui_str': 'evacetrapib'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",12092.0,0.296263,".001) when hsCRP levels were 2 mg/L or more but not less than 2 mg/L. Sensitivity analyses in the ACCELERATE placebo-treated group yielded similar significant associations exclusively in the group with hsCRP of 2 mg/L or more.
","[{'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Puri', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Benoit J', 'Initials': 'BJ', 'LastName': 'Arsenault', 'Affiliation': 'Québec Heart & Lung Institute, Université de Laval, Québec, Québec, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'St John', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Riesmeyer', 'Affiliation': 'Eli Lilly, Indianapolis, Indiana.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Ruotolo', 'Affiliation': 'Eli Lilly, Indianapolis, Indiana.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'McErlean', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Menon', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Cho', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Wolski', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Lincoff', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'MonashHeart, Department of Cardiology, Monash University, Clayton, Victoria, Australia.'}]",JAMA cardiology,['10.1001/jamacardio.2020.2413']
995,32645162,Patterns of Antiretroviral Therapy Use and Immunologic Profiles at Enrollment in the REPRIEVE Trial.,"BACKGROUND


Patterns of antiretroviral therapy (ART) use and immunologic correlates vary globally, and contemporary trends are not well described.
METHODS


The REPRIEVE trial (Randomized Trial to Prevent Vascular Events in HIV) enrolled persons with human immunodeficiency virus (HIV) who were aged 40-75 years, receiving ART, and had low-to-moderate cardiovascular disease risk. ART use was summarized within Global Burden of Disease (GBD) super-regions, with adjusted linear and logistic regression analyses examining associations with immune parameters and key demographics.
RESULTS


A total of 7770 participants were enrolled, with a median age of 50 years (interquartile range, 45-55 years); 31% were female, 43% were black or African American, 15% were Asian, 56% had a body mass index >25 (calculated as weight in kilograms divided by height in meters squared), and 49% were current or former smokers. The median CD4 T-cell count was 620/µL (interquartile range, 447-826/ µ L), and the median duration of prior ART use, 9.5 years (5.3-14.8) years. The most common ART regimens were nucleoside/nucleotide reverse-transcriptase inhibitor (NRTI) plus nonnucleoside reverse-transcriptase inhibitor (43%), NRTI plus integrase strand transfer inhibitor (25%), and NRTI plus protease inhibitor (19%). Entry ART varied by GBD region, with shifts during the trial enrollment period. In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
CONCLUSIONS


There were substantial variations in ART use by geographic region and over time, likely reflecting the local availability of specific medications, changes in treatment guidelines and provider/patient preferences. The analyses of CD4 cell counts and CD4/CD8 ratios may provide valuable insights regarding immune correlates and outcomes in people living with HIV.
CLINICAL TRIALS REGISTRATION


NCT02344290.",2020,"In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
","['HIV) enrolled persons with human immunodeficiency virus (HIV) who were aged 40-75 years, receiving ART, and had low-to-moderate cardiovascular disease risk', 'people living with HIV', '7770 participants were enrolled, with a median age of 50 years (interquartile range, 45-55 years); 31% were female, 43% were black or African American, 15% were Asian, 56% had a body mass index >25 (calculated as weight in kilograms divided by height in meters squared), and 49% were current or former smokers']",['nucleoside/nucleotide reverse-transcriptase inhibitor (NRTI)\u2005plus nonnucleoside reverse-transcriptase inhibitor'],"['GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts', 'entry CD4 cell count and CD4/CD8 ratio', 'median CD4 T-cell count']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}]","[{'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0028630', 'cui_str': 'Nucleotide'}, {'cui': 'C0282519', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C4277729', 'cui_str': 'Global Burden of Disease'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",7770.0,0.18883,"In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
","[{'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Fichtenbaum', 'Affiliation': 'Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Leon-Cruz', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.'}, {'ForeName': 'Markella V', 'Initials': 'MV', 'LastName': 'Zanni', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Carlos D', 'Initials': 'CD', 'LastName': 'Malvestutto', 'Affiliation': 'Division of Infectious Diseases, Ohio State University Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Kileel', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Van Schalkwyk', 'Affiliation': 'Family Centre for Research with Ubuntu, Division of Adult Infectious Diseases, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa.'}, {'ForeName': 'Nagalingeswaran', 'Initials': 'N', 'LastName': 'Kumarasamy', 'Affiliation': 'Infectious Diseases Medical Centre, Voluntary Health Services, Chennai, India.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': 'Hospital Clinic and University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Breno Riegel', 'Initials': 'BR', 'LastName': 'Santos', 'Affiliation': 'Infectious Diseases Service, Hospital Nossa, Senhora da Conceição/GHC, Porto Alegre, Brazil.'}, {'ForeName': 'Yvetot', 'Initials': 'Y', 'LastName': 'Joseph', 'Affiliation': 'Les Centres GHESKIO, Port-au-Prince, Haiti.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Siminski', 'Affiliation': 'Frontier Science and Technology Foundation, Amherst, Massachusetts, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Melbourne', 'Affiliation': 'HIV Medical Sciences, Gilead Sciences, Foster City, California, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Sponseller', 'Affiliation': 'Kowa Pharmaceuticals America, Montgomery, Alabama, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'National Heart, Lung and Blood Institute, Baltimore, Maryland, USA.'}, {'ForeName': 'Gerald S', 'Initials': 'GS', 'LastName': 'Bloomfield', 'Affiliation': 'Department of Medicine, Duke Global Health Institute and Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, University of California-Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jiaa259']
996,32646850,Prostate Imaging Quality (PI-QUAL): A New Quality Control Scoring System for Multiparametric Magnetic Resonance Imaging of the Prostate from the PRECISION trial.,"The PRECISION trial was a multicentre randomised study that demonstrated that multiparametric magnetic resonance imaging (mpMRI)-targeted biopsy is superior to standard transrectal ultrasound-guided biopsy for the detection of prostate cancer. The outcomes of studies reporting mpMRI-targeted biopsies are dependent on the quality of the mpMRI but there are currently no scoring systems available for evaluating this. We introduced a novel scoring system, the Prostate Imaging Quality (PI-QUAL) score, to assess the quality of scans in the PRECISION trial. PI-QUAL is a score on a Likert scale from 1 to 5, where 1 means that no mpMRI sequences are of diagnostic quality and 5 implies that each sequence is independently of optimal diagnostic quality. Fifty-eight out of 252 (23%) mpMRI scans chosen at random from each of the 22 centres in this trial were evaluated by two experienced radiologists from the coordinating trial centre, in consensus, blinded to pathology results. Overall, the mpMRI quality in the centres participating in PRECISION was good. MpMRI quality was of sufficient diagnostic quality (PI-QUAL ≥3) for 55 scans (95%) and of good or optimal diagnostic quality (PI-QUAL ≥4) for 35 scans (60%). Fifty-five out of 58 (95%) scans were of diagnostic quality for T2WI, followed by DWI (46/58 scans; 79%), and DCE (38/58 scans; 66%). Further validation of this scoring system is warranted. PATIENT SUMMARY: In this study we developed a scoring system (PI-QUAL) to assess the quality of multiparametric magnetic resonance imaging (mpMRI) in prostate cancer detection. We used scans from 22 centres that participated in the PRECISION trial. Although there was room for improvement in images that used intravenous contrast, we found that mpMRI in the PRECISION trial was of sufficient diagnostic quality (PI-QUAL score ≥3) for 95% of the scans.",2020,In this study we developed a scoring system (PI-QUAL) to assess the quality of multiparametric magnetic resonance imaging (mpMRI) in prostate cancer detection.,"['prostate cancer detection', 'Fifty-eight out of 252 (23']","['multiparametric magnetic resonance imaging (mpMRI)-targeted biopsy', 'standard transrectal ultrasound-guided biopsy', 'Prostate Imaging Quality (PI-QUAL', 'multiparametric magnetic resonance imaging (mpMRI']","['diagnostic quality', 'MpMRI quality', 'mpMRI quality', 'Prostate Imaging Quality (PI-QUAL) score']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",252.0,0.0461845,In this study we developed a scoring system (PI-QUAL) to assess the quality of multiparametric magnetic resonance imaging (mpMRI) in prostate cancer detection.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giganti', 'Affiliation': 'Department of Radiology, University College London Hospital NHS Foundation Trust, London, UK; Division of Surgery & Interventional Science, University College London, London, UK. Electronic address: f.giganti@ucl.ac.uk.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Allen', 'Affiliation': 'Department of Radiology, University College London Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Emberton', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, London, UK; Department of Urology, University College London Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Moore', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, London, UK; Department of Urology, University College London Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Veeru', 'Initials': 'V', 'LastName': 'Kasivisvanathan', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, London, UK; Department of Urology, University College London Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology oncology,['10.1016/j.euo.2020.06.007']
997,32652012,A Chicken Production Intervention and Additional Nutrition Behavior Change Component Increased Child Growth in Ethiopia: A Cluster-Randomized Trial.,"BACKGROUND


Chicken production in the context of nutrition-sensitive agriculture may benefit child nutrition in low-income settings.
OBJECTIVES


This study evaluated effects of 1) a chicken production intervention [African Chicken Genetic Gains (ACGG)], and 2) the ACGG intervention with nutrition-sensitive behavior change communication (BCC) [ACGG + Agriculture to Nutrition (ATONU)], on child nutrition and health outcomes and hypothesized intermediaries.
METHODS


Forty ACGG villages received 25 genetically improved chickens and basic husbandry guidance; of these, 20 ACGG + ATONU villages in addition received a nutrition-sensitive behavior change and homegardening intervention; 20 control clusters received no intervention. We assessed effects of the interventions on height-for-age z scores (HAZ), weight-for-age z scores (WAZ), and weight-for-height z scores (WHZ) at 9 (midline) and 18 mo (endline) through unadjusted and adjusted ordinary least squares (OLS) regressions. We examined the interventions' effects on hypothesized intermediaries including egg production and consumption, dietary diversity, women's empowerment, income, child morbidities, anemia, and chicken management practices through OLS and log binomial models.
RESULTS


Data included 829 children aged 0-36 mo at baseline. ACGG + ATONU children had higher midline HAZ [mean difference (MD): 0.28; 95% CI: 0.02, 0.54] than controls. The ACGG group had higher HAZ (MD: 0.28; 95% CI: 0.05, 0.50) and higher WAZ (MD: 0.18; 95% CI: 0.01, 0.36) at endline than controls; after adjusting for potential baseline imbalance, effects were similar but not statistically significant. At endline, differences in ACGG + ATONU children's HAZ and WAZ compared with controls were similar in magnitude to those of ACGG, but not statistically significant. There were no differences in anthropometry between the intervention groups. ACGG + ATONU children had higher dietary diversity and egg consumption than ACGG children at endline. Both interventions showed improvements in chicken management practices. The interventions did not increase anemia, diarrhea, fever, or vomiting, and the ACGG + ATONU group at midline showed reduced risk of fever.
CONCLUSIONS


A chicken production intervention with or without nutrition-sensitive BCC may have benefited child nutrition and did not increase morbidity.This trial was registered at clinicaltrials.gov as NCT03152227.",2020,"The ACGG group had higher HAZ (MD: 0.28; 95% CI: 0.05, 0.50) and higher WAZ (MD: 0.18; 95% CI: 0.01, 0.36) at endline than controls; after adjusting for potential baseline imbalance, effects were similar but not statistically significant.","['Increased Child Growth in Ethiopia', 'Forty ACGG villages received 25 genetically improved chickens and basic husbandry guidance; of these, 20\xa0ACGG\xa0+\xa0ATONU villages in addition received a', '829 children aged 0-36 mo at baseline']","['nutrition-sensitive behavior change and homegardening intervention; 20 control clusters received no intervention', 'Chicken Production Intervention and Additional Nutrition Behavior Change Component', 'chicken production intervention [African Chicken Genetic Gains (ACGG', 'ACGG intervention with nutrition-sensitive behavior change communication (BCC) [ACGG\xa0+ Agriculture to Nutrition (ATONU']","['anemia, diarrhea, fever, or vomiting', 'chicken management practices', 'height-for-age z scores (HAZ), weight-for-age z scores (WAZ), and weight-for-height z scores (WHZ', 'risk of fever', ""egg production and consumption, dietary diversity, women's empowerment, income, child morbidities, anemia, and chicken management practices through OLS and log binomial models"", 'morbidity']","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0008051', 'cui_str': 'Gallus gallus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008051', 'cui_str': 'Gallus gallus'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0001829', 'cui_str': 'Farming'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0008051', 'cui_str': 'Gallus gallus'}, {'cui': 'C0600585', 'cui_str': 'Practice Management'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424670', 'cui_str': 'Weight for height'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0026338', 'cui_str': 'Models, Binomial'}]",829.0,0.130307,"The ACGG group had higher HAZ (MD: 0.28; 95% CI: 0.05, 0.50) and higher WAZ (MD: 0.18; 95% CI: 0.01, 0.36) at endline than controls; after adjusting for potential baseline imbalance, effects were similar but not statistically significant.","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Passarelli', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Ambikapathi', 'Affiliation': 'Department of Public Health, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Nilupa S', 'Initials': 'NS', 'LastName': 'Gunaratna', 'Affiliation': 'Department of Public Health, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Madzorera', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Chelsey R', 'Initials': 'CR', 'LastName': 'Canavan', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Abdallah R', 'Initials': 'AR', 'LastName': 'Noor', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Amare', 'Initials': 'A', 'LastName': 'Worku', 'Affiliation': 'Addis Continental Institute of Public Health, Addis Ababa, Ethiopia.'}, {'ForeName': 'Yemane', 'Initials': 'Y', 'LastName': 'Berhane', 'Affiliation': 'Addis Continental Institute of Public Health, Addis Ababa, Ethiopia.'}, {'ForeName': 'Semira', 'Initials': 'S', 'LastName': 'Abdelmenan', 'Affiliation': 'Addis Continental Institute of Public Health, Addis Ababa, Ethiopia.'}, {'ForeName': 'Simbarashe', 'Initials': 'S', 'LastName': 'Sibanda', 'Affiliation': 'Food, Agriculture and Natural Resources Policy Analysis Network, Pretoria, South Africa.'}, {'ForeName': 'Bertha', 'Initials': 'B', 'LastName': 'Munthali', 'Affiliation': 'Food, Agriculture and Natural Resources Policy Analysis Network, Pretoria, South Africa.'}, {'ForeName': 'Tshilidzi', 'Initials': 'T', 'LastName': 'Madzivhandila', 'Affiliation': 'Food, Agriculture and Natural Resources Policy Analysis Network, Pretoria, South Africa.'}, {'ForeName': 'Lindiwe M', 'Initials': 'LM', 'LastName': 'Sibanda', 'Affiliation': 'Food, Agriculture and Natural Resources Policy Analysis Network, Pretoria, South Africa.'}, {'ForeName': 'Kumlachew', 'Initials': 'K', 'LastName': 'Geremew', 'Affiliation': 'International Livestock Research Institute, Addis Ababa, Ethiopia.'}, {'ForeName': 'Tadelle', 'Initials': 'T', 'LastName': 'Dessie', 'Affiliation': 'International Livestock Research Institute, Addis Ababa, Ethiopia.'}, {'ForeName': 'Solomon', 'Initials': 'S', 'LastName': 'Abegaz', 'Affiliation': 'Ethiopian Institute of Agricultural Research, Addis Ababa, Ethiopia.'}, {'ForeName': 'Getnet', 'Initials': 'G', 'LastName': 'Assefa', 'Affiliation': 'Ethiopian Institute of Agricultural Research, Addis Ababa, Ethiopia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sudfeld', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McConnell', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Davison', 'Affiliation': 'Boston College School of Social Work, Boston, MA, USA.'}, {'ForeName': 'Wafaie', 'Initials': 'W', 'LastName': 'Fawzi', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa181']
998,32654022,Two different therapies for the middle turbinate during endoscopic sinus surgery for chronic rhinosinusitis.,"BACKGROUND


The population of patients with chronic rhinosinusitis (CRS) has greatly increased. When medical treatment fails, endoscopic sinus surgery (ESS) is considered. In the present study, the value of two different therapies for the middle turbinate to optimize surgical outcomes was observed. Our objective was to determine a better management approach for the middle turbinate to effectively preserve the middle turbinate mucosa and function and avoid complications following ESS, such as nasal adhesions on the operative side.
METHODS


Thirty patients [group A; treated prior to 2015 (primary surgery)] undergoing resection of the middle turbinate bone during complete ESS for CRS and 30 patients [group B; treated after 2015 (later surgery)] undergoing middle turbinate preservation and multiapproach therapy during complete ESS for CRS were observed. Nasal cavities were compared using perioperative sinus endoscopy (POSE) and Lund-Kennedy (LKES) scores preoperatively and at 15 days, 2 months and 1 year after ESS.
RESULTS


Preoperatively, the POSE (8.83 ± 3.81 vs 9.15 ± 3.85, p = 0.45, for groups A and B, respectively) and LKES (4.23 ± 0.74 vs 4.13 ± 0.70, p = 0.34) scores were similar between groups. In group A, anterior adhesions were reported on six sides of the middle turbinate, severe adhesions were observed on two sides, mild adhesions were observed on one side, and adhesions occurred on two sides during follow-up. After retreatment, adhesions were still observed on two sides at 1 year. In group B, only mild anterior adhesions were observed on two sides. There was no difference between group A and group B at 15 days, and the POSE (4.31 ± 1.19 vs 4.07 ± 1.42, p = 0.11, for groups A and B, respectively) and LKES (3.35 ± 0.82 vs 3.33 ± 0.90, p = 0.91) scores were similar between groups. There was no significant difference in LKES (0.22 ± 0.49 vs 0.10 ± 0.35, p = 0.15) scores at 1 year between the two groups. There was a significant difference in the nasal cavities between group A and group B at 2 months and 1 year, where group B showed a better endoscopic appearance than group A at 2 months and 1 year (with POSE scores of 3.48 ± 0.83 vs 2.43 ± 1.38 (p = 0.00) and LKES scores of 1.35 ± 0.86 vs 1.15 ± 0.90 (p = 0.02) at 2 months for groups A and B, respectively, and POSE scores of 1.00 ± 0.96 vs 0.62 ± 0.87 (p = 0.001) at 1 year for groups A and B, respectively).
CONCLUSIONS


Our results show that middle turbinate preservation and combined therapy was a better ESS method for CRS. Multiapproach middle conchoplasty, which is predominately a submucoperiosteal surgery, can preserve more of the mucosa and functions of the middle turbinate. Unlike the single-approach middle conchoplasty described in previous research, multiapproach middle conchoplasty is achieved by combining a three-step surgical procedure (""surgery, packing and removal"") with ""cocktail-style"" postoperative packing and removal.",2020,"There was a significant difference in the nasal cavities between group A and group B at 2 months and 1 year, where group B showed a better endoscopic appearance than group A at 2 months and 1 year (with POSE scores of 3.48 ± 0.83 vs 2.43 ± 1.38 (p = 0.00) and LKES scores of 1.35 ± 0.86 vs 1.15 ± 0.90 (p = 0.02) at 2 months for groups A and B, respectively, and POSE scores of 1.00 ± 0.96 vs 0.62 ± 0.87 (p = 0.001) at 1 year for groups A and B, respectively).
","['patients with chronic rhinosinusitis (CRS', 'chronic rhinosinusitis', 'Thirty patients [group A']","['endoscopic sinus surgery', 'treated prior to 2015 (primary surgery)] undergoing resection of the middle turbinate bone during complete ESS for CRS and 30 patients [group B; treated after 2015 (later surgery)] undergoing middle turbinate preservation and multiapproach therapy', 'endoscopic sinus surgery (ESS']","['nasal cavities', 'endoscopic appearance', 'LKES', 'LKES scores', 'severe adhesions', 'mild anterior adhesions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0225435', 'cui_str': 'Middle nasal turbinate structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0027423', 'cui_str': 'Nasal cavity structure'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}]",,0.0319759,"There was a significant difference in the nasal cavities between group A and group B at 2 months and 1 year, where group B showed a better endoscopic appearance than group A at 2 months and 1 year (with POSE scores of 3.48 ± 0.83 vs 2.43 ± 1.38 (p = 0.00) and LKES scores of 1.35 ± 0.86 vs 1.15 ± 0.90 (p = 0.02) at 2 months for groups A and B, respectively, and POSE scores of 1.00 ± 0.96 vs 0.62 ± 0.87 (p = 0.001) at 1 year for groups A and B, respectively).
","[{'ForeName': 'Meichan', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': ""Department of Otorhinolaryngology, Guangzhou Twelfth People's Hospital (Guangzhou Otolarynology-Head and Neck Surgery Hospital), Tianhe District, No 1. Tianqiang Road, Guangzhou, 510620, Guangdong, China. zhumeichan@126.com.""}, {'ForeName': 'Yongyi', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': ""Department of Otorhinolaryngology, Guangzhou Twelfth People's Hospital (Guangzhou Otolarynology-Head and Neck Surgery Hospital), Tianhe District, No 1. Tianqiang Road, Guangzhou, 510620, Guangdong, China. yungyi@188.com.""}, {'ForeName': 'Huicheng', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': ""Department of Otorhinolaryngology, Guangzhou Twelfth People's Hospital (Guangzhou Otolarynology-Head and Neck Surgery Hospital), Tianhe District, No 1. Tianqiang Road, Guangzhou, 510620, Guangdong, China.""}, {'ForeName': 'Yunwen', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Otorhinolaryngology, Guangzhou Twelfth People's Hospital (Guangzhou Otolarynology-Head and Neck Surgery Hospital), Tianhe District, No 1. Tianqiang Road, Guangzhou, 510620, Guangdong, China.""}, {'ForeName': 'Guojie', 'Initials': 'G', 'LastName': 'Tan', 'Affiliation': ""Department of Otorhinolaryngology, Guangzhou Twelfth People's Hospital (Guangzhou Otolarynology-Head and Neck Surgery Hospital), Tianhe District, No 1. Tianqiang Road, Guangzhou, 510620, Guangdong, China.""}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06184-4']
999,32658497,Treatment effects on pain catastrophizing and cutaneous allodynia symptoms in women with migraine and overweight/obesity.,"OBJECTIVE


Pain catastrophizing and cutaneous allodynia represent two risk factors for greater headache-related disability. Yet, there is limited knowledge of the extent to which these risk factors are modifiable and whether nonpharmacological treatment-related changes are associated with migraine improvements. Using data from the Women's Health and Migraine (WHAM) study, a randomized controlled trial that compared effects of behavioral weight loss (BWL) and migraine education (ME) in women with migraine and overweight/obesity, we tested whether: (a) BWL versus ME produced greater changes in pain catastrophizing and allodynia from baseline across posttreatment and follow-up time points, and (b) whether these improvements were associated with improvements in headache disability.
METHOD


Women ( N  = 110) were randomly assigned to 16 weeks of either BWL or ME and assessed at baseline, posttreatment, and follow up (32 weeks). Multilevel mixed effects modeling tested: (a) for between-groups differences in pain catastrophizing and allodynia changes over time, and (b) associations of changes in pain catastrophizing and allodynia with changes in headache disability, adjusting for migraine severity and weight loss.
RESULTS


Both BWL and ME had significant reductions in pain catastrophizing and allodynia from baseline to posttreatment and follow up, and the improvements were comparable across conditions. Reductions in pain catastrophizing and cutaneous allodynia were associated with significant reductions in headache disability, even when controlling for intervention-related improvements in migraine and weight loss.
CONCLUSION


Pain catastrophizing and allodynia are not only reduced after nonpharmacologic treatments for migraine, but greater improvements are associated with greater reductions in headache-related disability, independent of migraine severity. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Both BWL and ME had significant reductions in pain catastrophizing and allodynia from baseline to posttreatment and follow up, and the improvements were comparable across conditions.","['women with migraine and overweight/obesity', 'Women ( N  = 110']","['BWL or ME', 'behavioral weight loss (BWL) and migraine education (ME']","['pain catastrophizing and cutaneous allodynia symptoms', 'headache-related disability', 'pain catastrophizing and allodynia changes over time, and (b) associations of changes in pain catastrophizing and allodynia with changes in headache disability, adjusting for migraine severity and weight loss', 'headache disability', 'pain catastrophizing and cutaneous allodynia', 'pain catastrophizing and allodynia', 'migraine and weight loss']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C1274924', 'cui_str': 'Cutaneous allodynia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",110.0,0.102198,"Both BWL and ME had significant reductions in pain catastrophizing and allodynia from baseline to posttreatment and follow up, and the improvements were comparable across conditions.","[{'ForeName': 'Samantha G', 'Initials': 'SG', 'LastName': 'Farris', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'J Graham', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychiatry and Human Behavior.'}, {'ForeName': 'Mindy M', 'Initials': 'MM', 'LastName': 'Kibbey', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jelena M', 'Initials': 'JM', 'LastName': 'Pavlovic', 'Affiliation': 'Department of Neurology.'}, {'ForeName': 'Kristine J', 'Initials': 'KJ', 'LastName': 'Steffen', 'Affiliation': 'School of Pharmacy.'}, {'ForeName': 'Dale S', 'Initials': 'DS', 'LastName': 'Bond', 'Affiliation': 'Department of Psychiatry and Human Behavior.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000920']
1000,32609653,Baseline pain characteristics predict pain reduction after physical therapy in women with chronic pelvic pain. Secondary analysis of data from a randomized controlled trial.,"Background and aims Women with chronic pelvic pain represent a heterogeneous group, and it is suggested that the existence of sub-groups can explain varying results and inconclusiveness in clinical trials. Some predictors of treatment outcome are suggested, but the evidence is limited. The primary aim of this study was to explore if selected pre-treatment characteristics of the participants in a recently conducted randomized controlled trial were associated with treatment outcome. Methods In this study secondary analysis of data collected in a randomized trial were conducted. The participants were women with chronic pelvic pain randomized to two different physical therapy treatments. Analyses in this study were performed for the whole group as a cohort. The primary outcome measure was change in pain intensity from baseline to 12 months, measured with the numeric rating scale (0-10). The women were asked to rate their mean pelvic pain intensity during the last 7 days. Based on previous research and on available variables from the randomized controlled trial four potential predictive factors were derived from the baseline data and assessed one by one in a linear regression model, adjusted for age and treatment group. The variables with strongest association (p < 0.10) with the primary outcome were further included in a multivariable linear regression model with backward selection, adjusted for age and treatment group. Results Fifty women (mean age 38.1, SD = 12.2) were included in the analysis. For these women the mean change in pain intensity was -1.2 points (95% CI -1.8 to -0.7) from baseline to 12 months. The multivariable regression model showed that pelvic pain duration of 6 years or more was associated with less decrease in pain intensity with a regression coefficient of 1.3 (95% CI 0.3-2.4). Baseline pain intensity was associated with higher pain reduction after PT treatment with a regression coefficient per SD increase in baseline pain of -0.6 (95% CI -1.1 to -0.1). None of the women with main pain site other places than in the pelvis reported any pain reduction after physical therapy treatment, but due to the small numbers the predictor was not included in the regression analysis. Conclusions We identified that pelvic pain duration of 6 years or more was associated with less pain reduction, and that higher baseline pain intensity was associated with higher pain reduction after physical therapy treatment in this sample of women with chronic pelvic pain. For the variable main pain site other places than the pelvis the results are unsure due to small numbers. Implications Based on our finding of long pain duration as a negative predictor for pain reduction, we emphasize that early intervention is important. Many of the participants in our RCT reported pelvic surgeries or other treatments prior to referral for PT, and we suggest that referral to a non-invasive intervention such as PT should be considered at an earlier stage. In order to tailor interventions to the individual women's needs, thorough baseline assessments, preferably in a multidisciplinary setting, should be performed.",2020,Baseline pain intensity was associated with higher pain reduction after PT treatment with a regression coefficient per SD increase in baseline pain of -0.6 (95% CI -1.1 to -0.1).,"['Results Fifty women (mean age 38.1, SD\u2009=\u200912.2) were included in the analysis', 'participants were women with chronic pelvic pain randomized to two different', 'women with chronic pelvic pain']","['physical therapy treatments', 'physical therapy']","['pain reduction', 'change in pain intensity', 'pain intensity', 'pelvic pain duration', 'numeric rating scale', 'Baseline pain intensity', 'pelvic surgeries', 'mean pelvic pain intensity']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}]","[{'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",50.0,0.245129,Baseline pain intensity was associated with higher pain reduction after PT treatment with a regression coefficient per SD increase in baseline pain of -0.6 (95% CI -1.1 to -0.1).,"[{'ForeName': 'Ane S', 'Initials': 'AS', 'LastName': 'Nygaard', 'Affiliation': 'Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Gro K', 'Initials': 'GK', 'LastName': 'Haugstad', 'Affiliation': 'Institute of Physical Therapy, Oslo Met-Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Wilsgaard', 'Affiliation': 'Department of Community Medicine, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Øian', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Stedenfeldt', 'Affiliation': ""Norwegian Advisory Unit on Complex Symptom Disorders, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.""}]",Scandinavian journal of pain,['10.1515/sjpain-2020-0026']
1001,32611217,Public Perceptions of Artificial Intelligence and Robotics in Medicine.,"Objective:  To understand better the public perception and comprehension of medical technology such as artificial intelligence (AI) and robotic surgery. In addition to this, to identify sensitivity to their use to ensure acceptability and quality of counseling.  Subjects and Methods:  A survey was conducted on a convenience sample of visitors to the MN Minnesota State Fair ( n  = 264). Participants were randomized to receive one of two similar surveys. In the first, a diagnosis was made by a physician and in the second by an AI application to compare confidence in human and computer-based diagnosis.  Results:  The median age of participants was 45 (interquartile range 28-59), 58% were female ( n  = 154)  vs  42% male ( n  = 110), 69% had completed at least a bachelor's degree, 88% were Caucasian ( n  = 233)  vs  12% ethnic minorities ( n  = 31) and were from 12 states, mostly from the Upper Midwest. Participants had nearly equal trust in AI  vs  physician diagnoses. However, they were significantly more likely to trust an AI diagnosis of cancer over a doctor's diagnosis when responding to the version of the survey that suggested that an AI could make medical diagnoses ( p  = 9.32e-06). Though 55% of respondents ( n  = 145) reported that they were uncomfortable with automated robotic surgery, the majority of the individuals surveyed (88%) mistakenly believed that partially autonomous surgery was already happening. Almost all (94%,  n  = 249) stated that they would be willing to pay for a review of medical imaging by an AI if available.  Conclusion:  Most participants express confidence in AI providing medical diagnoses, sometimes even over human physicians. Participants generally express concern with surgical AI, but they mistakenly believe that it is already being performed. As AI applications increase in medical practice, health care providers should be cognizant of the potential amount of misinformation and sensitivity that patients have to how such technology is represented.",2020,"Almost all (94%, n=249) stated they would be willing to pay for a review of medical imaging by an AI if available.
","[""The median age of participants was 45 (IQR 28-59), 58% were female (n=154) vs. 42% male (n=110), 69% had completed at least a bachelor's degree, 88% were Caucasian (n=233) vs. 12% ethnic minorities (n=31) and were from 12 states, most from the Upper Midwest"", 'convenience sample of visitors to the MN Minnesota State Fair (n= 264']",[],['acceptability and quality of counseling'],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C2911689', 'cui_str': 'Fair'}]",[],"[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",88.0,0.0315296,"Almost all (94%, n=249) stated they would be willing to pay for a review of medical imaging by an AI if available.
","[{'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Stai', 'Affiliation': 'Department of Computer Science and Engineering, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Heller', 'Affiliation': 'Department of Computer Science and Engineering, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'McSweeney', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Rickman', 'Affiliation': 'Department of Computer Science and Engineering, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Blake', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Ranveer', 'Initials': 'R', 'LastName': 'Vasdev', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Zach', 'Initials': 'Z', 'LastName': 'Edgerton', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Resha', 'Initials': 'R', 'LastName': 'Tejpaul', 'Affiliation': 'Department of Computer Science and Engineering, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Peterson', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Arveen', 'Initials': 'A', 'LastName': 'Kalapara', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Regmi', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Papanikolopoulos', 'Affiliation': 'Department of Computer Science and Engineering, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Weight', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}]",Journal of endourology,['10.1089/end.2020.0137']
1002,32616883,Exercise intervention lowers aberrant serum WISP-1 levels with insulin resistance in breast cancer survivors: a randomized controlled trial.,"Insulin resistance is associated with increased risk for and recurrence of breast cancer. Recently, Wnt1-inducible signaling pathway protein-1 (WISP-1) was reported to impair glucose metabolism and insulin sensitivity. In various cancer tissues, Wnt signaling is upregulated and induces further oncogenic and metastatic activity. However, the effects of exercise on serum levels of WISP-1 and its upstream β-catenin have not been studied in cancer patients. We investigated the effects of exercise training on Wnt signaling and insulin sensitivity in breast cancer survivors (BCS). This single-center trial randomized 46 BCS into either 12-week exercise or control groups (1:1), and included an additional 12 age-matched healthy women. Kinanthropometric parameters, serum Wnt signaling markers, and gluco-lipid profiles were evaluated before and after the intervention. Serum β-catenin and WISP-1 concentrations were significantly higher in BCS than in healthy subjects. There was a positive correlation between β-catenin and WISP-1 levels. Exercise training in BCS significantly reduced body fat and waist circumference and enhanced aerobic and muscular fitness. Exercise decreased β-catenin and WISP-1 levels and improved gluco-lipid profiles. There was a notable correlation between changes in HOMA-IR indexes and serum WISP-1, but not with β-catenin during the exercise intervention. In conclusion, a 12-week community-based exercise intervention resulted in significant reductions in serum β-catenin and WISP-1 levels, accompanied by favorable improvements in body composition, physical fitness, and biochemical parameters in BCS. We also highlight that this is the first report concerning effects of exercise on circulating β-catenin and WISP-1 levels and correlations between WISP-1 and insulin sensitivity, which could be important for determining prognoses for BCS.",2020,Serum β-catenin and WISP-1 concentrations were significantly higher in BCS than in healthy subjects.,"['12 age-matched healthy women', 'breast cancer survivors', 'breast cancer survivors (BCS', 'cancer patients']","['exercise training', 'Exercise intervention', 'Exercise training', 'community-based exercise intervention']","['body composition, physical fitness, and biochemical parameters in BCS', 'Kinanthropometric parameters, serum Wnt signaling markers, and gluco-lipid profiles', 'Serum β-catenin and WISP-1 concentrations', 'body fat and waist circumference and enhanced aerobic and muscular fitness', 'HOMA-IR indexes and serum WISP-1', 'β-catenin and WISP-1 levels and improved gluco-lipid profiles', 'serum β-catenin and WISP-1 levels', 'β-catenin and WISP-1 levels']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1564904', 'cui_str': 'Catenin Proteins'}, {'cui': 'C1449212', 'cui_str': 'WISP1 protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",46.0,0.0220849,Serum β-catenin and WISP-1 concentrations were significantly higher in BCS than in healthy subjects.,"[{'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Chang', 'Affiliation': 'Mitohormesis Research Center, Wonju College of Medicine, Yonsei University, Wonju, Korea.'}, {'ForeName': 'Tae Ho', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Department of Physiology, Wonju College of Medicine, Yonsei University, Wonju, Korea.'}, {'ForeName': 'In Deok', 'Initials': 'ID', 'LastName': 'Kong', 'Affiliation': 'Department of Physiology, Wonju College of Medicine, Yonsei University, Wonju, Korea. kong@yonsei.ac.kr.'}]",Scientific reports,['10.1038/s41598-020-67794-w']
1003,32618258,Impact of Different Strategies for Delivering Supplemental Zinc on Selected Fecal Markers of Environmental Enteric Dysfunction among Young Laotian Children: A Randomized Controlled Trial.,"The objective of this study was to assess the impact of different strategies for delivering supplemental zinc on fecal myeloperoxidase (MPO), neopterin (NEO), and calprotectin (CAL) among young Laotian children. In a double-blind controlled trial, children aged 6-23 months were randomized to receive either daily preventive zinc (PZ) tablets (7 mg/day), daily micronutrient powder (MNP; containing 10 mg zinc and 14 other micronutrients), therapeutic zinc (TZ) supplements for diarrhea treatment (20 mg/day for 10 days), or daily placebo powder and followed for ∼36 weeks. Stool samples were collected at baseline and endline. Fecal MPO, NEO, and CAL concentrations were determined in a randomly selected subsample of 720 children using commercially available ELISA kits. At baseline, the mean age was 14.1 ± 4.9 months and prevalence of stunting was 39%. The endline prevalence of stunting was 43%; there was no overall treatment effect on physical growth in the parent trial. At endline, the mean (95% CI) MPO in the PZ group was 1,590 [1,396; 1,811] ng/mL and did not differ from that in the MNP (1,633 [1,434; 1,859] ng/mL), TZ (1,749 [1,535; 1,992] ng/mL), and control (1,612 [1,415; 1,836] ng/mL) groups ( P  = 0.749). Similarly, there was no overall treatment effect on NEO and CAL concentrations ( P  = 0.226 and 0.229, respectively). In this population, the provision of PZ or TZ supplements or MNP had no impact on growth or environmental enteric dysfunction (EED) as assessed by fecal MPO, NEO, and CAL. Additional research is needed to better understand the etiology and proposed mechanisms of EED pathogenesis.",2020,"Similarly, there was no overall treatment effect on NEO and CAL concentrations ( P  = 0.226 and 0.229, respectively).","['young Laotian children', 'Young Laotian Children', 'children aged 6-23 months']","['daily micronutrient powder (MNP; containing 10 mg zinc and 14 other micronutrients), therapeutic zinc (TZ) supplements for diarrhea treatment', 'placebo powder', 'daily preventive zinc (PZ) tablets', 'TZ', 'PZ or TZ supplements or MNP', 'MNP']","['prevalence of stunting', 'fecal myeloperoxidase (MPO), neopterin (NEO), and calprotectin (CAL', 'physical growth', 'Fecal MPO, NEO, and CAL concentrations', 'growth or environmental enteric dysfunction (EED', 'NEO and CAL concentrations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0023033', 'cui_str': 'Lao language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C3541396', 'cui_str': 'Zinc'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0068527', 'cui_str': 'Neopterin'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",720.0,0.568268,"Similarly, there was no overall treatment effect on NEO and CAL concentrations ( P  = 0.226 and 0.229, respectively).","[{'ForeName': 'Guy-Marino', 'Initials': 'GM', 'LastName': 'Hinnouho', 'Affiliation': 'Helen Keller International, Washington, District of Columbia.'}, {'ForeName': 'K Ryan', 'Initials': 'KR', 'LastName': 'Wessells', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Maxwell A', 'Initials': 'MA', 'LastName': 'Barffour', 'Affiliation': 'Public Health Program, College of Health and Human Services, Missouri State University, Springfield, Missouri.'}, {'ForeName': 'Somphou', 'Initials': 'S', 'LastName': 'Sayasone', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Sengchanh', 'Initials': 'S', 'LastName': 'Kounnavong', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}, {'ForeName': 'Sonja Y', 'Initials': 'SY', 'LastName': 'Hess', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0106']
1004,32620260,Effects of anaesthesia method and tourniquet use on recovery following total knee arthroplasty: a randomised controlled study.,"BACKGROUND


We investigated the effects of spinal and general anaesthesia and surgical tourniquet on acute pain and early recovery after total knee arthroplasty (TKA).
METHODS


Patients (n=413) were randomised to four parallel groups: spinal anaesthesia with or without tourniquet, and general anaesthesia with or without tourniquet. The primary outcome was patient-controlled i.v. oxycodone consumption over 24 postoperative hours.
RESULTS


Results from 395 subjects were analysed. Median i.v. oxycodone consumption did not differ between the four groups (spinal anaesthesia without [36.6 mg] and with tourniquet [38.0 mg], general anaesthesia without [42.3 mg] and with tourniquet [42.5 mg], P=0.42), between spinal (37.7 mg) and general anaesthesia (42.5 mg) groups (median difference -3.1, 95% confidence interval [CI] -7.4 to 1.2, P=0.15) and between tourniquet and no-tourniquet groups (40.0 vs 40.0 mg, median difference -0.8, CI -5.1 to 3.5, P=0.72). Vomiting incidence was higher with spinal than with general anaesthesia (21% [42/200] vs 13% [25/194], CI 1.05 to 3.1, P=0.034). The mean haemoglobin decrease was greater without than with tourniquet (-3.0 vs -2.5 g dl -1 , mean difference -0.48, CI -0.65 to -0.32, P<0.001). No differences were observed in pain, pain management, incidences of blood transfusions, in-hospital complications, or length of hospital stay.
CONCLUSIONS


For TKA, spinal and general anaesthesia with or without tourniquet did not differ in 24-h postoperative opioid consumption, pain management, blood transfusions, in-hospital complications, and length of hospital stay. Vomiting incidence was higher in the spinal than in the general anaesthesia group. Tourniquet use caused smaller decreases in haemoglobin levels.
CLINICAL TRIAL REGISTRATION


EudraCT 2016-002035-15.",2020,"No differences were observed in pain, pain management, incidences of blood transfusions, in-hospital complications, or length of hospital stay.
","['395 subjects were analysed', 'total knee arthroplasty', 'Patients (n=413', 'after total knee arthroplasty (TKA']","['anaesthesia method and tourniquet', 'spinal anaesthesia with or without tourniquet, and general anaesthesia with or without tourniquet', 'spinal and general anaesthesia and surgical tourniquet', 'EudraCT', 'oxycodone']","['acute pain and early recovery', 'mean haemoglobin decrease', 'pain, pain management, incidences of blood transfusions, in-hospital complications, or length of hospital stay', 'haemoglobin levels', 'Vomiting incidence', '24-h postoperative opioid consumption, pain management, blood transfusions, in-hospital complications, and length of hospital stay', 'consumption']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}]","[{'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",395.0,0.127039,"No differences were observed in pain, pain management, incidences of blood transfusions, in-hospital complications, or length of hospital stay.
","[{'ForeName': 'Riku', 'Initials': 'R', 'LastName': 'Palanne', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, Peijas Hospital, HUS Helsinki University Hospital, Helsinki, Finland; Department of Anaesthesiology and Intensive Care, Central Finland Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Rantasalo', 'Affiliation': 'Department of Orthopaedics and Traumatology, Arthroplasty Center, Peijas Hospital, HUS Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Vakkuri', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, Peijas Hospital, HUS Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Madanat', 'Affiliation': 'Department of Orthopaedics and Traumatology, Arthroplasty Center, Peijas Hospital, HUS Helsinki University Hospital, Helsinki, Finland; Terveystalo Kamppi, Helsinki, Finland.'}, {'ForeName': 'Klaus T', 'Initials': 'KT', 'LastName': 'Olkkola', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, University of Helsinki and HUS Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Lahtinen', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, Peijas Hospital, HUS Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Reponen', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, Peijas Hospital, HUS Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Linko', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, Peijas Hospital, HUS Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Vahlberg', 'Affiliation': 'Department of Clinical Medicine, Biostatistics, University of Turku and Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Noora', 'Initials': 'N', 'LastName': 'Skants', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, Peijas Hospital, HUS Helsinki University Hospital, Helsinki, Finland. Electronic address: noora.skants@hus.fi.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.03.036']
1005,32621885,Low-Molecular-Weight Heparin vs Warfarin for Thromboprophylaxis in Children With Coronary Artery Aneurysms After Kawasaki Disease: A Pragmatic Registry Trial.,"BACKGROUND


The substantial risk of thrombosis in large coronary artery aneurysms (CAAs) (maximum z-score ≥ 10) after Kawasaki disease (KD) mandates effective thromboprophylaxis. We sought to determine the effectiveness of anticoagulation (low-molecular-weight heparin [LMWH] or warfarin) for thromboprophylaxis in large CAAs.
METHODS


Data from 383 patients enrolled in the International KD Registry (IKDR) were used. Time-to-event analysis was used to account for differences in treatment duration and follow-up.
RESULTS


From diagnosis onward (96% received acetylsalicylic acid concomitantly), 114 patients received LMWH (median duration 6.2 months, interquartile range [IQR] 2.5-12.7), 80 warfarin (median duration 2.2 years, IQR 0.9-7.1), and 189 no anticoagulation. Cumulative incidence of coronary artery thrombosis with LMWH was 5.7 ± 3.0%, with warfarin 6.7 ± 3.7%, and with no anticoagulation 20.6 ± 3.0% (P < 0.001) at 2.5 years after the start of thromboprophylaxis (LMWH vs warfarin HR 1.5, 95% confidence interval [CI] 0.4-5.1; P = 0.56). A total of 51/63 patients with coronary artery thrombosis received secondary thromboprophylaxis (ie, thromboprophylaxis after a previous thrombus): 27 LMWH, 24 warfarin. There were no differences in incidence of further coronary artery thrombosis between strategies (HR 2.9, 95% CI 0.6-13.5; P = 0.19). Severe bleeding complications were generally rare (1.6 events per 100 patient-years) and were noted equally for patients on LMWH and warfarin (HR 2.3, 95% CI 0.6-8.9; P = 0.25).
CONCLUSIONS


LMWH and warfarin appear to have equivalent effectiveness for preventing thrombosis in large CAAs after KD, although event rates for secondary thromboprophylaxis and safety outcomes were low. Based on our findings, all patients with CAA z-score ≥ 10 should receive anticoagulation, but the choice of agent might be informed by secondary risk factors and patient preferences.",2020,"There were no differences in incidence of further coronary artery thrombosis between strategies (HR 2.9, 95% CI 0.6-13.5; P = 0.19).","['51/63 patients with coronary artery thrombosis received secondary thromboprophylaxis (ie, thromboprophylaxis after a previous thrombus): 27 LMWH, 24', 'Children with Coronary Artery Aneurysms', 'Data from 383 patients enrolled in the International KD Registry (IKDR) were used']","['LMWH', 'acetylsalicylic acid', 'warfarin', 'anticoagulation (low-molecular-weight heparin [LMWH] or warfarin', 'LMWH and warfarin', 'Low-Molecular-Weight Heparin vs Warfarin']","['Cumulative incidence of coronary artery thrombosis', 'Severe bleeding complications', 'incidence of further coronary artery thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010072', 'cui_str': 'Coronary artery thrombosis'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010051', 'cui_str': 'Aneurysm of coronary vessels'}, {'cui': 'C0026691', 'cui_str': 'Acute febrile mucocutaneous lymph node syndrome'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0010072', 'cui_str': 'Coronary artery thrombosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",383.0,0.190654,"There were no differences in incidence of further coronary artery thrombosis between strategies (HR 2.9, 95% CI 0.6-13.5; P = 0.19).","[{'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Manlhiot', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Jane W', 'Initials': 'JW', 'LastName': 'Newburger', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Tisiana', 'Initials': 'T', 'LastName': 'Low', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Nagib', 'Initials': 'N', 'LastName': 'Dahdah', 'Affiliation': 'Division of Pediatric Cardiology, Centre Hospitalier Universitaire Ste-Justine, University of Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Mackie', 'Affiliation': ""Stollery Children's Hospital, Edmonton, Alberta, Canada.""}, {'ForeName': 'Geetha', 'Initials': 'G', 'LastName': 'Raghuveer', 'Affiliation': ""Children's Mercy Hospital, Kansas City, Missouri, USA.""}, {'ForeName': 'Therese M', 'Initials': 'TM', 'LastName': 'Giglia', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Dallaire', 'Affiliation': 'Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec, Canada.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Mathew', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Runeckles', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Elfriede', 'Initials': 'E', 'LastName': 'Pahl', 'Affiliation': ""Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.""}, {'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Harahsheh', 'Affiliation': ""Pediatrics-Cardiology, Children's National Health System/George Washington University, Washington, District of Columbia, USA.""}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Norozi', 'Affiliation': 'Department of Paediatrics, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sarah D', 'Initials': 'SD', 'LastName': 'de Ferranti', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Friedman', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Anji T', 'Initials': 'AT', 'LastName': 'Yetman', 'Affiliation': ""Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, USA.""}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Kutty', 'Affiliation': ""Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, USA.""}, {'ForeName': 'Tapas', 'Initials': 'T', 'LastName': 'Mondal', 'Affiliation': ""McMaster Children's Hospital, Hamilton, Ontario, Canada.""}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'McCrindle', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada. Electronic address: brian.mccrindle@sickkids.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Canadian journal of cardiology,['10.1016/j.cjca.2020.01.016']
1006,32623343,"""Sushi roll"" technique for precise total tongue functional reconstruction using a pre-sutured femoral anterolateral myocutaneous flap.","OBJECTIVES


Reconstruction of the total tongue after cancer resection remains one of the challenges in head and neck surgery. Inadequate reconstruction after subtotal or total glossectomy defects leads to poor quality of life. The aim of this study was to explore an economical, practical and effective flap design for functional tongue reconstruction.
MATERIAL AND METHODS


Sixty patients were randomly divided into two groups, namely, a ""Sushi roll"" technique group (30 patients) and a conventional surgery group (30 patients). Then, the patients underwent total or subtotal tongue reconstruction. Swallowing function, speech intelligibility, cosmetic results, and quality of life were assessed with the appropriate scales. Outcomes were analysed, and a p-value <0.05 was considered significant.
RESULTS


The perioperative recovery of the ""Sushi roll"" group was superior to that of the conventional group. Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
CONCLUSION


The innovative ""Sushi roll"" anterolateral thigh myocutaneous flap approach for total tongue reconstruction creates a free neotongue tip with adequate volume and protuberance and causes minimal damage to the donor site, producing acceptable swallowing function and speech intelligibility.",2020,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","['head and neck surgery', 'Sixty patients']","['Sushi roll"" technique group', 'conventional surgery', 'Sushi roll"" technique', 'subtotal tongue reconstruction']","['speech intelligibility', 'swallowing function', 'Swallowing function, speech intelligibility, cosmetic results, and quality of life', 'perioperative recovery', 'cosmetic results']","[{'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0399188', 'cui_str': 'Tongue reconstruction'}]","[{'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0201308,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: drzhouxi0504@csu.edu.cn.'}, {'ForeName': 'Zhi-Jing', 'Initials': 'ZJ', 'LastName': 'He', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yu-Xiong', 'Initials': 'YX', 'LastName': 'Su', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, Faculty of Dentistry, the University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhao Jian', 'Initials': 'ZJ', 'LastName': 'Gong', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Han Jiang', 'Initials': 'HJ', 'LastName': 'Wu', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104866']
1007,32645310,A Randomized Controlled Trial Comparing Subconjunctival Injection to Direct Scleral Application of Mitomycin C in Trabeculectomy.,"PURPOSE


To compare the efficacy of intraoperative scleral application with subconjunctival injection of mitomycin C (MMC) in trabeculectomy.
DESIGN


Prospective, randomized, interventional study.
METHODS


This study took place in a single clinical practice in an academic setting. Patients had medically uncontrolled glaucoma as indicated by high intraocular pressure (IOP), worsening visual field, or optic nerve head changes in whom primary trabeculectomy was indicated. Patients were older than 18 years with medically uncontrolled glaucoma and no history of incisional glaucoma surgery. Patients were randomized to MMC delivered by preoperative subconjunctival injection or by intraoperative direct scleral application using surgical sponges during trabeculectomy. Comprehensive eye examinations were conducted at 1 day, 1 week, 6 weeks, 3 months, and 6 months postoperatively. Subconjunctival 5-fluorouracil injections were given postoperatively, as needed. The primary outcome was the proportion of patients who demonstrated IOP of <21 mm Hg and ≥30% reduction in IOP from baseline. Secondary outcome measures included the number of IOP-lowering medications, bleb morphology using the Indiana Bleb Appearance Grading Scale, and complication rates.
RESULTS


Participants (n = 100) were randomized into groups matched for baseline demographics, glaucoma status, and baseline IOP. At 6 months, there were no significant differences between the injection (n = 38) and sponge (n = 40) groups in surgical success (P = .357), mean IOP (P = .707), number of glaucoma medications (P = 1.000), bleb height (P = .625), bleb extension (P = .216), bleb vascularity (P = .672), or complications rates.
CONCLUSION


Both techniques of MMC delivery (subconjunctival injection and direct scleral application) resulted in comparable surgical outcomes and bleb morphologies.",2020,"At six months, there were no significant differences between the injection (n = 38) and sponge (n = 40) group in surgical success (p = 0.357), mean IOP (p = 0.707), number of glaucoma medications (p = 1.000), bleb height (p = 0.625), bleb extension (p = 0.216), bleb vascularity (p = 0.672), or complications rates.
","['Participants (n=100', 'academic setting Patient or Study Population: Patients older than 18 years with medically uncontrolled glaucoma and no previous history of incisional glaucoma surgery Intervention or Observation Procedure(s): Subjects', 'Trabeculectomy', 'Subjects with medically uncontrolled glaucoma as indicated by high intraocular pressure (IOP), worsening visual field, or optic nerve head changes in whom primary trabeculectomy is indicated']","['Subconjunctival Injection', 'MMC delivery (subconjunctival injection and direct scleral application', 'mitomycin C (MMC', 'Subconjunctival 5-fluorouracil injections', 'preoperative subconjunctival injection or intraoperative direct scleral application using surgical sponges during trabeculectomy', 'Mitomycin C', 'MMC']","['number of glaucoma medications', 'bleb height', 'bleb vascularity', 'bleb extension', 'number of IOP lowering medications, bleb morphology using the Indiana Bleb Appearance Grading Scale, and complication rates', 'mean IOP', 'surgical success', 'surgical outcomes and bleb morphologies']","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0197489', 'cui_str': 'Operation for glaucoma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0029127', 'cui_str': 'Optic disc structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0197180', 'cui_str': 'Subconjunctival injection'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0442183', 'cui_str': 'Subconjunctival'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0038937', 'cui_str': 'Surgical sponge'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0021206', 'cui_str': 'Indiana'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",100.0,0.153502,"At six months, there were no significant differences between the injection (n = 38) and sponge (n = 40) group in surgical success (p = 0.357), mean IOP (p = 0.707), number of glaucoma medications (p = 1.000), bleb height (p = 0.625), bleb extension (p = 0.216), bleb vascularity (p = 0.672), or complications rates.
","[{'ForeName': 'Jiun L', 'Initials': 'JL', 'LastName': 'Do', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Benjamin Y', 'Initials': 'BY', 'LastName': 'Xu', 'Affiliation': 'USC Roski Eye Institute, Department of Ophthalmology, Keck School of Medicine at the University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Wong', 'Affiliation': 'USC Roski Eye Institute, Department of Ophthalmology, Keck School of Medicine at the University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Camp', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Ngai', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Long', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Proudfoot', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Sasan', 'Initials': 'S', 'LastName': 'Moghimi', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Diya', 'Initials': 'D', 'LastName': 'Yan', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Derek S', 'Initials': 'DS', 'LastName': 'Welsbie', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Weinreb', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA. Electronic address: rweinreb@health.ucsd.edu.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.07.002']
1008,32651047,Do peer social relationships mediate the harmful effects of a housing mobility experiment on boys' risky behaviors?,"PURPOSE


The purpose of this study was to understand why a housing mobility experiment caused harmful effects on adolescent boys' risky behaviors.
METHODS


Moving to Opportunity (MTO) (1994-2010) randomly assigned volunteer families to a treatment group receiving a Section 8 rental voucher or a public housing control group. Our outcome was a global risky behavior index (RBI; measured in 2002, n = 750 boys) measuring the fraction of 10 items the youth engaged in, 6 measuring past 30-day substance use and 4 measuring recent risky sexual behavior. Potential mediators (measured in 2002) included peer social relationships (e.g., peer drug use, peer gang membership).
RESULTS


The voucher treatment main effect on boys' RBI was harmful (B (SE) = 0.05 (0.02), 95% CI 0.01, 0.08), and treatment marginally increased having friends who used drugs compared to controls (B (SE) = 0.67 (0.23), 95% CI 0.22, 1.12). Having friends who used drugs marginally mediated the MTO treatment effect on RBI (indirect effect: B (SE) = 0.02(.01), 95% CI -0.002, 0.04), reducing the total treatment effect by 39%.
CONCLUSIONS


Incorporating additional supports into housing voucher programs may help support teenage boys who experience disruptions to their social networks, to buffer potential adverse consequences of residential mobility.",2020,"Having friends who used drugs marginally mediated the MTO treatment effect on RBI (indirect effect: B (SE) = 0.02(.01), 95% CI -0.002, 0.04), reducing the total treatment effect by 39%.
","[""adolescent boys' risky behaviors""]",['Section 8 rental voucher or a public housing control group'],"['total treatment effect', 'risky sexual behavior', 'global risky behavior index (RBI', 'peer social relationships (e.g., peer drug use, peer gang membership']","[{'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0034028', 'cui_str': 'Public Housing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}]",,0.0719186,"Having friends who used drugs marginally mediated the MTO treatment effect on RBI (indirect effect: B (SE) = 0.02(.01), 95% CI -0.002, 0.04), reducing the total treatment effect by 39%.
","[{'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Schmidt', 'Affiliation': 'Minnesota Population Center, University of Minnesota, Minneapolis. Electronic address: schmidtn@umn.edu.'}, {'ForeName': 'Naomi Harada', 'Initials': 'NH', 'LastName': 'Thyden', 'Affiliation': 'Department of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis.'}, {'ForeName': 'Huiyun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Minnesota Population Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Theresa L', 'Initials': 'TL', 'LastName': 'Osypuk', 'Affiliation': 'Minnesota Population Center, University of Minnesota, Minneapolis; Department of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis.'}]",Annals of epidemiology,['10.1016/j.annepidem.2020.05.007']
1009,32653074,"Once-daily, single-inhaler mometasone-indacaterol-glycopyrronium versus mometasone-indacaterol or twice-daily fluticasone-salmeterol in patients with inadequately controlled asthma (IRIDIUM): a randomised, double-blind, controlled phase 3 study.","BACKGROUND


Patients with asthma who are inadequately controlled on inhaled corticosteroid-long-acting β 2 -adrenoceptor agonist (ICS-LABA) combinations might benefit from the addition of a long-acting muscarinic receptor antagonist. The aim of the IRIDIUM study was to assess the efficacy and safety of a once-daily, single-inhaler combination of mometasone furoate, indacaterol acetate, and glycopyrronium bromide (MF-IND-GLY) versus ICS-LABA in patients with inadequately controlled asthma.
METHODS


In this 52-week, double-blind, double-dummy, parallel-group, active-controlled phase 3 study, patients were recruited from 415 sites across 41 countries. Patients aged 18 to 75 years with symptomatic asthma despite treatment with medium-dose or high-dose ICS-LABA, at least one exacerbation in the previous year, and a percentage of predicted FEV 1  of less than 80% were included. Enrolled patients were randomly assigned (1:1:1:1:1) via interactive response technology to receive medium-dose or high-dose MF-IND-GLY (80 μg, 150 μg, 50 μg; 160 μg, 150 μg, 50 μg) or MF-IND (160 μg, 150 μg; 320 μg, 150 μg) once daily via Breezhaler, or high-dose fluticasone-salmeterol (FLU-SAL; 500 μg, 50 μg) twice daily via Diskus. The primary outcome was change from baseline in trough FEV 1  with MF-IND-GLY versus MF-IND at week 26 in patients in the full analysis set, analysed by means of a mixed model for repeated measures. Safety was assessed in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, NCT02571777, and is completed.
FINDINGS


Between Dec 8, 2015, and Jun 14, 2019, 3092 of 4851 patients screened were randomly assigned (medium-dose MF-IND-GLY, n=620; high-dose MF-IND-GLY, n=619; medium-dose MF-IND, n=617; high-dose MF-IND, n=618; high-dose FLU-SAL, n=618). 2747 (88·8%) patients completed the 52-week treatment and 321 (10·4%) started but discontinued study treatment prematurely. Medium-dose MF-IND-GLY (treatment difference [Δ] 76 mL [95% CI 41-111]; p<0·001) and high-dose MF-IND-GLY (Δ 65 mL [31-99]; p<0·001) showed superior improvement in trough FEV 1  versus corresponding doses of MF-IND at week 26. Improvements in trough FEV 1  were greater for both medium-dose MF-IND-GLY (99 mL [64-133]; p<0·001) and high-dose MF-IND-GLY (119 mL [85-154]; p<0·001) than for high-dose FLU-SAL at week 26. Overall, the incidence of adverse events was balanced across the treatment groups. Seven deaths were reported (one with medium-dose MF-IND-GLY, two with high-dose MF-IND-GLY, and four with high-dose MF-IND) during the study; none of these deaths was considered by the investigators to be caused by study drugs or other study-related factors.
INTERPRETATION


Once-daily, single-inhaler MF-IND-GLY improved lung function versus ICS-LABA combinations (MF-IND and FLU-SAL) in patients with inadequately controlled asthma. The safety profile was similar across treatment groups. MF-IND-GLY therefore constitutes a good treatment option in these patients.
FUNDING


Novartis Pharmaceuticals.",2020,[31-99]; p<0·001) showed superior improvement in trough FEV 1  versus corresponding doses of MF-IND at week 26.,"['2747', 'Between Dec 8, 2015, and Jun 14, 2019, 3092 of 4851 patients screened', 'Patients with asthma who are inadequately controlled on inhaled corticosteroid-long-acting β 2', 'Patients aged 18 to 75 years with symptomatic asthma despite treatment with medium-dose or high-dose ICS-LABA, at least one exacerbation in the previous year, and a percentage of predicted FEV 1  of less than 80% were included', 'patients with inadequately controlled asthma (IRIDIUM', 'patients with inadequately controlled asthma', 'patients were recruited from 415 sites across 41 countries']","['Medium-dose MF-IND-GLY', 'interactive response technology to receive medium-dose or high-dose MF-IND-GLY', 'adrenoceptor agonist (ICS-LABA', 'MF-IND', 'daily via Breezhaler, or high-dose fluticasone-salmeterol (FLU-SAL', 'mometasone furoate, indacaterol acetate, and glycopyrronium bromide (MF-IND-GLY', 'ICS-LABA combinations (MF-IND and FLU-SAL', 'mometasone-indacaterol-glycopyrronium versus mometasone-indacaterol or twice-daily fluticasone-salmeterol', 'ICS-LABA']","['Safety', 'superior improvement in trough FEV', 'change from baseline in trough FEV 1  with MF-IND-GLY versus MF-IND', 'safety profile', 'efficacy and safety', 'adverse events']","[{'cui': 'C0162508', 'cui_str': 'jun Oncogene'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022071', 'cui_str': 'Iridium'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0939232', 'cui_str': 'salmeterol and fluticasone'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1.0,0.468901,[31-99]; p<0·001) showed superior improvement in trough FEV 1  versus corresponding doses of MF-IND at week 26.,"[{'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, and Groningen Research Institute for Asthma and COPD, Groningen, Netherlands. Electronic address: h.a.m.kerstjens@umcg.nl.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Maspero', 'Affiliation': 'Allergy and Respiratory Research Unit, Fundación Centro Investigacion de Enfermedades Alergicas y Respiratorias, Buenos Aires, Argentina.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Chapman', 'Affiliation': 'Division of Respiratory Medicine, Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'van Zyl-Smit', 'Affiliation': 'Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Motoi', 'Initials': 'M', 'LastName': 'Hosoe', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Tanase', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Lavecchia', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Pethe', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Shu', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""D'Andrea"", 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30190-9']
1010,32653075,"Once-daily mometasone plus indacaterol versus mometasone or twice-daily fluticasone plus salmeterol in patients with inadequately controlled asthma (PALLADIUM): a randomised, double-blind, triple-dummy, controlled phase 3 study.","BACKGROUND


Fixed-dose combinations (FDCs) of inhaled corticosteroids (ICS) and long-acting β 2 -adrenoceptor agonists (LABA) are considered safe and efficacious in asthma management. Most available FDCs require twice-daily dosing to achieve optimum therapeutic effect. The objective of the PALLADIUM study was to assess the efficacy and safety of once-daily FDC of mometasone furoate plus indacaterol acetate (MF-IND) versus mometasone furoate (MF) monotherapy in patients with inadequately controlled asthma.
METHODS


This 52-week, double-blind, triple-dummy, parallel-group, phase 3 study recruited patients from 316 centres across 24 countries. Patients aged 12 to 75 years with a documented diagnosis of asthma for at least 1 year, percentage of predicted FEV 1  of 50-85%, and an Asthma Control Questionnaire 7 score of at least 1·5 despite treatment with medium-dose or high-dose ICS or low-dose ICS plus LABA were included. A history of asthma exacerbations was not a study requirement. Participants were randomily assigned (1:1:1:1:1) via interactive response technology to receive one of the following treatments for 52 weeks: high-dose MF-IND (320 μg, 150 μg) or medium-dose MF-IND (160 μg, 150 μg) once daily via Breezhaler; high-dose MF (800 μg [400 μg twice daily]) or medium-dose MF (400 μg once daily) via Twisthaler; or high-dose fluticasone propionate-salmeterol xinafoate (FLU-SAL; 500 μg, 50 μg) twice daily via Diskus. Participants received placebo via inhalation through the Breezhaler, Twisthaler, or Diskus devices in the mornings and evenings, as appropriate. The primary endpoint was improvement in trough FEV 1  with high-dose and medium-dose MF-IND versus respective MF doses from baseline at 26 weeks, analysed in the full analysis set by means of a mixed model for repeated measures. High-dose MF-IND once daily was compared with high-dose FLU-SAL twice daily for non-inferiority on improving trough FEV 1  at week 26 with a margin of -90 mL using mixed model for repeated measures as one of the secondary endpoints. Safety was assessed in all patients who had received at least one dose of study drug. This study is registered with ClinicalTrials.gov, NCT02554786, and is completed.
FINDINGS


Between Dec 29, 2015, and May 4, 2018, 2216 patients were randomly assigned (high-dose MF-IND, n=445; medium-dose MF-IND, n=439; high-dose MF, n=442; medium-dose MF, n=444; high-dose FLU-SAL, n=446), of which 1973 (89·0%) completed the study treatment and 234 (10·6%) prematurely discontinued study treatment. High-dose MF-IND (treatment difference [Δ] 132 mL [95% CI 88 to 176]; p<0·001) and medium-dose MF-IND (Δ 211 mL [167 to 255]; p<0·001) showed superiority in improving trough FEV 1  over corresponding MF doses from baseline at week 26. High-dose MF-IND was non-inferior to high-dose FLU-SAL in improving trough FEV 1  from baseline at week 26 (Δ 36 mL [-7 to 80]; p=0·101). Overall, the incidence of adverse events was similar across the treatment groups.
INTERPRETATION


Once-daily FDC of ICS and LABA (MF-IND) significantly improved lung function over ICS monotherapy (MF) at week 26; high-dose MF-IND was non-inferior to twice-daily combination of ICS and LABA (high-dose FLU-SAL) for improvement in trough FEV 1 . The combination of MF-IND provides a novel once-daily dry powder option for asthma control.
FUNDING


Novartis Pharmaceuticals.",2020,High-dose MF-IND was non-inferior to high-dose FLU-SAL in improving trough FEV 1  from baseline at week 26,"['Between Dec 29, 2015, and May 4, 2018', 'patients with inadequately controlled asthma ', 'Patients aged 12 to 75 years with a documented diagnosis of asthma for at least 1 year, percentage of predicted FEV 1  of 50-85%, and an Asthma Control Questionnaire 7 score of at least 1·5 despite treatment with medium-dose or high-dose ICS or low-dose ICS plus LABA were included', 'patients who had received at least one dose of study drug', '2216 patients', '3 study recruited patients from 316 centres across 24 countries', 'patients with inadequately controlled asthma']","['mometasone furoate plus indacaterol acetate (MF-IND', 'mometasone furoate (MF) monotherapy', 'MF-IND (320 μg, 150 μg) or medium-dose MF-IND (160 μg, 150 μg) once daily via Breezhaler; high-dose MF (800 μg [400 μg twice daily]) or medium-dose MF (400 μg once daily) via Twisthaler; or high-dose fluticasone propionate-salmeterol xinafoate (FLU-SAL; 500 μg, 50 μg) twice daily via Diskus', 'mometasone plus indacaterol versus mometasone', 'inhaled corticosteroids (ICS) and long-acting', 'fluticasone plus salmeterol', 'adrenoceptor agonists (LABA', 'placebo']","['Safety', 'trough FEV 1  with high-dose and medium-dose MF-IND', 'efficacy and safety', 'superiority in improving trough FEV', 'incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1622832', 'cui_str': 'Fluticasone Propionate-Salmeterol Xinafoate Drug Combination'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2216.0,0.644787,High-dose MF-IND was non-inferior to high-dose FLU-SAL in improving trough FEV 1  from baseline at week 26,"[{'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'van Zyl-Smit', 'Affiliation': 'Division of Pulmonology and UCT Lung Institute, Department of Medicine, University of Cape Town, Cape Town, South Africa. Electronic address: richard.vanzyl-smit@uct.ac.za.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Krüll', 'Affiliation': 'Institut für Allergie- und Asthmaforschung Berlin, IAAB, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gessner', 'Affiliation': 'Universitätsklinikum Leipzig, Leipzig, Germany; POIS Leipzig, Leipzig, Germany.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Gon', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Noga', 'Affiliation': 'Institut für Allergie- und Asthmaforschung Berlin, IAAB, Berlin, Germany.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Richard', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'de Los Reyes', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, US.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Shu', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, US.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Pethe', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, US.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Tanase', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""D'Andrea"", 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, US.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30178-8']
1011,32662220,Clinical and radiographic comparative study to evaluate the efficacy of restoring destroyed primary incisors using two different techniques-A pilot study.,"OBJECTIVE


The restoration of destroyed maxillary primary incisors is difficult because of the insufficient amount of coronal structure. This pilot study aimed to compare the efficacy of composite posts technique and glass fiber posts technique in restoring destroyed primary incisors.
MATERIALS AND METHODS


Thirty-six destroyed maxillary primary incisors in 11 children with early childhood caries were randomly assigned after endodontic treatment into two groups: glass fiber posts (n = 18) and composite resin posts (n = 18). Blinded clinical evaluation was made at 3, 6, 9, and 12 months and Blinded radiographic evaluation was made at 6 and 12 months. The evaluation was according to the FDI criteria. Data were analyzed with Fisher's exact test (α = .05).
RESULT


After 12 months post-treatment, the success rates were 88.2% in glass fiber posts group and 70.6% in composite resin posts group. There was no statistically significant difference between the two groups according to the evaluation criteria (p-value >.05).
CONCLUSION


Glass fiber posts technique and Composite posts technique may be used in the restoration of destroyed primary incisors.",2020,"There was no statistically significant difference between the two groups according to the evaluation criteria (p-value >.05).
",['Thirty-six destroyed maxillary primary incisors in 11 children with early childhood caries'],"['composite resin posts', 'composite posts technique and glass fiber posts technique', 'glass fiber posts']",['success rates'],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}]","[{'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0080038', 'cui_str': 'Post Technic'}, {'cui': 'C0060317', 'cui_str': 'Fiberglass'}]",[],11.0,0.0235983,"There was no statistically significant difference between the two groups according to the evaluation criteria (p-value >.05).
","[{'ForeName': 'Seba', 'Initials': 'S', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Paediatric Dentistry, Faculty of Dentistry, Tishreen University, Syria.'}, {'ForeName': 'Abdul Wahab', 'Initials': 'AW', 'LastName': 'Nourallah', 'Affiliation': 'Department of Paediatric Dentistry, Faculty of Dentistry, Tishreen University, Syria.'}]",Clinical and experimental dental research,['10.1002/cre2.307']
1012,32666599,"Human Fetal Cell Therapy in Huntington's Disease: A Randomized, Multicenter, Phase II Trial.","BACKGROUND


Huntington's disease is a rare, severe, inherited neurodegenerative disease in which we assessed the safety and efficacy of grafting human fetal ganglionic eminence intrastriatally.
METHODS


Patients at the early stage of the disease were enrolled in the Multicentric Intracerebral Grafting in Huntington's Disease trial, a delayed-start phase II randomized study. After a run-in period of 12 months, patients were randomized at month 12 to either the treatment group (transplanted at month 13-month 14) or the control group and secondarily treated 20 months later (month 33-month 34). The primary outcome was total motor score compared between both groups 20 months postrandomization (month 32). Secondary outcomes included clinical, imaging, and electrophysiological findings and a comparison of pregraft and postgraft total motor score slopes during the entire study period (month 0-month 52) regardless of the time of transplant.
RESULTS


Of 54 randomized patients, 45 were transplanted; 26 immediately (treatment) and 19 delayed (control). Mean total motor score at month 32 did not differ between groups (treated controls difference in means adjusted for M12: +2.9 [95% confidence interval, -2.8 to 8.6]; P = 0.31). Its rate of decline after transplantation was similar to that before transplantation. A total of 27 severe adverse events were recorded in the randomized patients, 10 of which were related to the transplant procedure. Improvement of procedures during the trial significantly decreased the frequency of surgical events.We found antihuman leucocytes antigen antibodies in 40% of the patients.
CONCLUSION


No clinical benefit was found in this trial. This may have been related to graft rejection. Ectopia and high track number negatively influence the graft outcome. Procedural adjustments substantially improved surgical safety. (ClinicalTrials.gov NCT00190450.) © 2020 International Parkinson and Movement Disorder Society.",2020,"Mean total motor score at month 32 did not differ between groups (treated controls difference in means adjusted for M12: +2.9 [95% confidence interval, -2.8 to 8.6]; P = 0.31).","[""Huntington's Disease"", ""Patients at the early stage of the disease were enrolled in the Multicentric Intracerebral Grafting in Huntington's Disease trial, a delayed-start phase II randomized study"", '54 randomized patients', '40% of the patients']",['Human Fetal Cell Therapy'],"['total motor score', 'antihuman leucocytes antigen antibodies', 'surgical safety', 'frequency of surgical events', 'Mean total motor score', 'clinical, imaging, and electrophysiological findings and a comparison of pregraft and postgraft total motor score slopes']","[{'cui': 'C0020179', 'cui_str': ""Huntington's chorea""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439743', 'cui_str': 'Multicentric'}, {'cui': 'C0442111', 'cui_str': 'Intracerebral'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0439170', 'cui_str': '% fetal cells'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023516', 'cui_str': 'Leukocyte'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]",54.0,0.162444,"Mean total motor score at month 32 did not differ between groups (treated controls difference in means adjusted for M12: +2.9 [95% confidence interval, -2.8 to 8.6]; P = 0.31).","[{'ForeName': 'Anne-Catherine', 'Initials': 'AC', 'LastName': 'Bachoud-Lévi', 'Affiliation': ""Assistance Publique-Hôpitaux de Paris, National Reference Center for Huntington's Disease, Neurology Department, Henri Mondor-Albert Chenevier Hospital, Créteil, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28201']
1013,32665529,Abaloparatide followed by alendronate in women ≥80 years with osteoporosis: post hoc analysis of ACTIVExtend.,"OBJECTIVE


Fracture risk increases with age, but few studies focus on persons ≥80 years. In the ACTIVE trial, treatment with abaloparatide for 18 months reduced osteoporotic fracture risk and increased bone mineral density. These effects were maintained with 24 months alendronate treatment in ACTIVExtend. We postulated that similar improvements in bone mineral density and safety would be demonstrated in women ≥80 years.
METHODS


Post hoc analyses of bone mineral density and fracture incidence in women with osteoporosis at high risk of fracture ≥80 years from ACTIVExtend.
RESULTS


In total, 56 women aged ≥80 years at ACTIVE baseline entered the ACTIVExtend study; 46 of these completed the study. Mean age was 83.3 years; other baseline characteristics were similar. At the end of ACTIVE, bone mineral density increased at all sites for abaloparatide versus placebo. Bone mineral density increased in parallel in both groups during alendronate therapy (19 to 43 months) in ACTIVExtend. At month 43, mean percent change in bone mineral density from baseline was 17.2% abaloparatide/alendronate versus 8.6% placebo/alendronate (P < 0.0001) at the lumbar spine, 5.3% abaloparatide/alendronate versus 3.0% placebo/alendronate (P = 0.024) at the total hip, and 4.6% abaloparatide/alendronate versus 3.1% placebo/alendronate (P = 0.044) at the femoral neck. Fracture incidence was low and did not differ significantly between groups. Sequential treatment with abaloparatide followed by alendronate was well tolerated; the proportion of participants reporting adverse events was similar between groups.
CONCLUSIONS


Sequential treatment with abaloparatide followed by alendronate (43 months follow-up) in this small subgroup of ACTIVExtend participants suggests abaloparatide is well tolerated and effective in women aged ≥80 years. : Video Summary:http://links.lww.com/MENO/A618.",2020,"At month 43, mean percent change in bone mineral density from baseline was 17.2% abaloparatide/alendronate versus 8.6% placebo/alendronate (P < 0.0001) at the lumbar spine, 5.3% abaloparatide/alendronate versus 3.0% placebo/alendronate (P = 0.024) at the total hip, and 4.6% abaloparatide/alendronate versus 3.1% placebo/alendronate (P = 0.044) at the femoral neck.","['56 women aged ≥80 years at ACTIVE baseline entered the ACTIVExtend study; 46 of these completed the study', 'persons ≥80 years', 'women ≥80 years', 'women ≥80 years with osteoporosis', 'women with osteoporosis at high risk of fracture ≥80 years from ACTIVExtend', 'women aged ≥80 years']","['Abaloparatide followed by alendronate', 'alendronate', ' Video Summary:http://links.lww.com/MENO/A618', 'placebo/alendronate', 'placebo']","['bone mineral density', 'bone mineral density and safety', 'tolerated; the proportion of participants reporting adverse events', 'Bone mineral density', 'osteoporotic fracture risk and increased bone mineral density', 'Fracture incidence', 'bone mineral density and fracture incidence']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0029464', 'cui_str': 'Osteosclerosis'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",56.0,0.236803,"At month 43, mean percent change in bone mineral density from baseline was 17.2% abaloparatide/alendronate versus 8.6% placebo/alendronate (P < 0.0001) at the lumbar spine, 5.3% abaloparatide/alendronate versus 3.0% placebo/alendronate (P = 0.024) at the total hip, and 4.6% abaloparatide/alendronate versus 3.1% placebo/alendronate (P = 0.044) at the femoral neck.","[{'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Greenspan', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Lorraine A', 'Initials': 'LA', 'LastName': 'Fitzpatrick', 'Affiliation': 'Radius Health, Inc., Waltham, MA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Mitlak', 'Affiliation': 'Radius Health, Inc., Waltham, MA.'}, {'ForeName': 'Yamei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Radius Health, Inc., Waltham, MA.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Harvey', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Deal', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McClung', 'Affiliation': 'Oregon Osteoporosis Center, Portland, OR.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001593']
1014,32663699,A randomized control trial of activity scheduling for caring for older adults with dementia and its impact on their spouse care-givers.,"INTRODUCTION


Participating in meaningful activities is important for any individual's wellbeing. Activity scheduling enables older adults with dementia and their spouse caregivers to structure their activities in accordance with the things they value.
METHODS


In examining the effectiveness of activity scheduling, this report details the results of a 12-week single-blinded randomized control trial using a parallel group experimental design.
RESULTS


From August 2018 to August 2019, 100 community-dwelling older adults with mild to moderate dementia and their spouses completed this study. The experimental group (n = 50) practicing activity scheduling showed improvements than in control group (n = 50), with respect to alleviating the impact of the caregiving role, reducing the behavioural and psychological symptoms of dementia, decreasing the caring demand and generally improving the quality of life, with Cohen's d = .61, .45, .50 and 43 respectively. Moreover, there were significant differences between the groups indicated that over time, the experimental group showed an improvement with regard to alleviating the role of caring, with Cohen's d = .64, and alleviating disruptive and depressive behavior, with an effect size of .45 and .50 respectively. The number of caring hours needed dropped from 6.98 to 5.98 h in the experimental group.
DISCUSSION & CONCLUSION


There were more activities that older adults with dementia and their spouse caregivers would like to do, and could participate in, than we had expected. Activity scheduling can facilitate their participation. This is a very important topic as non-pharmacological interventions are needed for this even-growing segment of the population.",2020,"The experimental group (n = 50) practicing activity scheduling showed improvements than in control group (n = 50), with respect to alleviating the impact of the caregiving role, reducing the behavioural and psychological symptoms of dementia, decreasing the caring demand and generally improving the quality of life, with Cohen's d = .61, .45, .50 and 43 respectively.","['older adults with dementia and its impact on their spouse care-givers', 'older adults with dementia and their spouse caregivers', 'From August 2018 to August 2019, 100 community-dwelling older adults with mild to moderate dementia and their spouses completed this study']",[],"['number of caring hours needed', 'alleviating disruptive and depressive behavior']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0087015', 'cui_str': 'Spouse Caregivers'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0283988,"The experimental group (n = 50) practicing activity scheduling showed improvements than in control group (n = 50), with respect to alleviating the impact of the caregiving role, reducing the behavioural and psychological symptoms of dementia, decreasing the caring demand and generally improving the quality of life, with Cohen's d = .61, .45, .50 and 43 respectively.","[{'ForeName': 'Frank Ho-Yin', 'Initials': 'FH', 'LastName': 'Lai', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong. Electronic address: frank.hy.lai@polyu.edu.hk.'}, {'ForeName': 'Elaine Wai-Hung', 'Initials': 'EW', 'LastName': 'Yan', 'Affiliation': 'Occupational Therapy Department, Kowloon Hospital, Hong Kong.'}, {'ForeName': 'Wing-Sze', 'Initials': 'WS', 'LastName': 'Tsui', 'Affiliation': ""Chung Hok Elderly Centre, Women's Welfare Club Western District, Hong Kong.""}, {'ForeName': 'Kathy Ka-Ying', 'Initials': 'KK', 'LastName': 'Yu', 'Affiliation': 'Tai Po Integrated Service for Senior Citizens, The Salvation Army Hong Kong & Macau Command, Hong Kong.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104167']
1015,32663820,Design and Baseline Characteristics of the Chlorthalidone in Chronic Kidney Disease (CLICK) Trial.,"BACKGROUND


Hypertension often accompanies chronic kidney disease (CKD), and diuretics are widely prescribed to reduce blood pressure (BP). Chlorthalidone (CTD) is a thiazide-like diuretic and an effective antihypertensive drug, yet little data exist to support its use in treating hypertension in individuals with advanced CKD.
METHODS


Chlorthalidone in Chronic Kidney Disease (CLICK) is a phase II, single-institution, multicenter, double-blind randomized control trial to test the hypothesis that CTD improves BP, through reduction of extracellular fluid volume, and results in target organ protection in patients with stage 4 CKD and poorly controlled hypertension. After a single-blind placebo run-in for 2 weeks and confirmation of hypertension by 24-h ambulatory blood pressure (ABP), patients are randomized to either placebo or CTD 12.5 mg once daily (QD) followed by dose escalation. Randomization is stratified by prior loop diuretic use, and the double-blind phase lasts 12 weeks. With a total of 160 patients, the study will have ≥80% power to detect a 6 mm Hg difference in systolic 24-h ABP between the 2 treatment groups.
RESULTS


Between June 2016 and October 2019, 131 patients have been randomized. The baseline characteristics are as follows: average age 65.8 years, 79% men, 36% Black, 79% with diabetes, mean eGFR 23.2 mL/min/1.73 m2, median urine albumin/creatinine ratio 923 mg/g, average number of BP medications 3.4, 60% on loop diuretics, and 24-h ABP averaged 141.7/73.8 mm Hg.
CONCLUSION


Among patients with stage 4 CKD and uncontrolled hypertension, CLICK should answer the question whether CTD is safe and effective.",2020,"median urine albumin/creatinine ratio 923 mg/g, average number of BP medications 3.4, 60% on loop diuretics, and 24-h ABP averaged 141.7/73.8 mm Hg.
","['patients with stage 4 CKD and poorly controlled hypertension', '160 patients', 'individuals with advanced CKD', 'patients with stage 4 CKD and uncontrolled hypertension', 'Chronic Kidney Disease (CLICK) Trial', 'Between June 2016 and October 2019, 131 patients have been randomized', 'follows: average age 65.8 years, 79% men, 36% Black, 79% with diabetes, mean eGFR 23.2 mL/min/1.73 m2', 'Chronic Kidney Disease (CLICK']","['Chlorthalidone (CTD', 'CTD', 'placebo or CTD', 'Chlorthalidone', 'placebo']","['blood pressure (BP', 'systolic 24-h ABP', 'median urine albumin/creatinine ratio 923 mg/g, average number of BP medications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2317473', 'cui_str': 'Chronic kidney disease stage 4'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]","[{'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0455271', 'cui_str': 'Urine albumin/creatinine ratio measurement'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",160.0,0.405279,"median urine albumin/creatinine ratio 923 mg/g, average number of BP medications 3.4, 60% on loop diuretics, and 24-h ABP averaged 141.7/73.8 mm Hg.
","[{'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Division of Nephrology, Department of Medicine, Indiana University School of Medicine and Richard L. Roudebush Veterans Administration Medical Center, Indianapolis, Indiana, USA, ragarwal@iu.edu.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Cramer', 'Affiliation': 'Division of Nephrology, Department of Medicine, Indiana University School of Medicine and Richard L. Roudebush Veterans Administration Medical Center, Indianapolis, Indiana, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Balmes-Fenwick', 'Affiliation': 'Division of Nephrology, Department of Medicine, Indiana University School of Medicine and Richard L. Roudebush Veterans Administration Medical Center, Indianapolis, Indiana, USA.'}, {'ForeName': 'Arjun D', 'Initials': 'AD', 'LastName': 'Sinha', 'Affiliation': 'Division of Nephrology, Department of Medicine, Indiana University School of Medicine and Richard L. Roudebush Veterans Administration Medical Center, Indianapolis, Indiana, USA.'}, {'ForeName': 'Fangqian', 'Initials': 'F', 'LastName': 'Ouyang', 'Affiliation': 'Department of Biostatistics, Richard M. Fairbanks School of Public Health, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Wanzhu', 'Initials': 'W', 'LastName': 'Tu', 'Affiliation': 'Department of Biostatistics, Richard M. Fairbanks School of Public Health, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}]",American journal of nephrology,['10.1159/000508700']
1016,32668833,"Randomized, controlled trial comparing respiratory and analgesic effects of interscalene, anterior suprascapular, and posterior suprascapular nerve blocks for arthroscopic shoulder surgery.","Background


Interscalene brachial plexus block (ISB) provides excellent analgesia for arthroscopic shoulder surgeries but is associated with adverse effects including hemidiaphragmatic paresis. We aimed to compare the respiratory effects, forced vital capacity (FVC), and forced expiratory volume in 1 second (FEV1) between suprascapular nerve block (SSB) and ISB.
METHODS


Sixty patients were recruited and randomized into ISB, anterior SSB, and posterior SSB groups. FVC, FEV1, and diaphragmatic excursion were evaluated at baseline and 30 minutes after intervention. Blocks were performed under ultrasound guidance with 15 ml of 0.5% ropivacaine. Pain scores were assessed at 6, 12, and 24 hours postoperatively.
RESULTS


The ISB group showed a reduced FVC of 31.2% ± 17.5% (mean ± SD), while the anterior and posterior SSB groups had less reduction of 3.6% ± 18.6% and 6.8% ± 6.5%, respectively (P < 0.001). The ISB group showed more reduction in diaphragmatic excursion than the anterior and posterior SSB groups (median [IQR]): -85.7% (-95.3% to -63.3%) vs. -1.8% (-13.1% to 2.3%) and -1.2% (-8.8% to 16.8%), respectively (P < 0.001). The median pain scores (IQR) in the ISB and anterior SSB groups were lower than those in the posterior SSB group at 6 hours on movement: 0 (0-2), 1.8 (0-4.5) vs. 5 (2.5-8), respectively (P = 0.002). There was no significant difference in oxycodone consumption postoperatively.
CONCLUSIONS


Anterior SSB preserves lung function and has a comparable analgesic effect as ISB. Thus, it is recommended for arthroscopic shoulder surgeries, especially in patients who have reduced lung function.",2020,"Median pain scores (IQR) in ISB and anterior SSB groups were lower than the posterior SSB group at 6 hours on movement, 0","['patients who have reduced lung function', 'arthroscopic shoulder surgeries', 'Methods\n\n\nSixty patients']","['interscalene block, anterior suprascapular, and posterior suprascapular nerve block', 'posterior SSB', 'ropivacaine', '\n\n\nInterscalene brachial plexus block (ISB']","['oxycodone consumption', 'diaphragmatic excursion', 'Median pain scores (IQR', 'respiratory effects, forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1), of suprascapular nerve block (SSB', 'forced vital capacity of mean (SD', 'Pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0232086', 'cui_str': 'Diaphragmatic excursion'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",60.0,0.0807569,"Median pain scores (IQR) in ISB and anterior SSB groups were lower than the posterior SSB group at 6 hours on movement, 0","[{'ForeName': 'Yean Chin', 'Initials': 'YC', 'LastName': 'Lim', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Changi General Hospital, Singapore.'}, {'ForeName': 'Zhao Kun', 'Initials': 'ZK', 'LastName': 'Koo', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Changi General Hospital, Singapore.'}, {'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Ho', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Changi General Hospital, Singapore.'}, {'ForeName': 'See Seong', 'Initials': 'SS', 'LastName': 'Chang', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Changi General Hospital, Singapore.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Manohara', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Changi General Hospital, Singapore.'}, {'ForeName': 'Qian Jun', 'Initials': 'QJ', 'LastName': 'Tong', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Changi General Hospital, Singapore.'}]",Korean journal of anesthesiology,['10.4097/kja.20141']
1017,32619458,"Acute psychological stress, autonomic function, and arterial stiffness among women.","This study aimed to investigate the effect of acute psychological stress on autonomic function and arterial stiffness, and to test a mediating role of changes in autonomic function between acute stress and arterial stiffness. Eighty-five healthy female adults were randomized into either an experimental or control group. The Trier Social Stress Test (TSST) was used to induce acute psychological stress. Autonomic function (measured by pre-ejection period [PEP] from cardiac impedance and high frequency [HF] of heart rate variability [HRV]) and arterial stiffness (measured by carotid and femoral pulse wave velocity [cfPWV] and augmentation index [AIx]) were assessed before and after the TSST. The mean age of the participants was 28.78 (±9.84) years old. Experimental group participants had a significant increase in cfPWV (p = .025) and AIx (p = .017) following the stressor, compared with those in the control group, after controlling for age, body mass index, and systolic blood pressure. However, no significant group differences were observed in changes in PEP (p = .181) and HF (p = .058). Changes in PEP and HF were neither associated with changes in cfPWV (p = .975 and p = .654, respectively), nor in AIx (p = .376 and p = .323, respectively). The results suggest that even a brief period of mild to moderate stress, which does not cause sustainable changes in autonomic function, may still exert significant adverse effects on arterial stiffness. The changes in arterial stiffness were not related to changes in autonomic function. Future experimental studies with several measurement points are recommended to identify distinct effects of stress on autonomic function and arterial stiffness.",2020,"Experimental group participants had a significant increase in cfPWV (p = .025) and AIx (p = .017) following the stressor, compared with those in the control group, after controlling for age, body mass index, and systolic blood pressure.","['The mean age of the participants was 28.78 (±9.84) years old', 'Eighty-five healthy female adults', 'women']",['Trier Social Stress Test (TSST'],"['heart rate variability [HRV]) and arterial stiffness (measured by carotid and femoral pulse wave velocity [cfPWV] and augmentation index [AIx', 'cfPWV', 'Autonomic function', 'Acute psychological stress, autonomic function, and arterial stiffness', 'arterial stiffness', 'autonomic function and arterial stiffness', 'systolic blood pressure', 'autonomic function', 'changes in PEP']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0686752', 'cui_str': 'Well female adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0999177', 'cui_str': 'Aix'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031642', 'cui_str': 'Phosphoenolpyruvate'}]",85.0,0.0168326,"Experimental group participants had a significant increase in cfPWV (p = .025) and AIx (p = .017) following the stressor, compared with those in the control group, after controlling for age, body mass index, and systolic blood pressure.","[{'ForeName': 'Jeongok G', 'Initials': 'JG', 'LastName': 'Logan', 'Affiliation': 'University of Virginia, School of Nursing, McLeod Hall 4011, 225 Jeanette Lancaster Way, Charlottesville, VA 22903, United States. Electronic address: jl3zj@virginia.edu.'}, {'ForeName': 'Bethany A', 'Initials': 'BA', 'LastName': 'Teachman', 'Affiliation': 'University of Virginia, Department of Psychology, 207 Gilmer Hall, Charlottesville, VA 22903, United States. Electronic address: bat5x@virginia.edu.'}, {'ForeName': 'Xiaoyue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'University of Virginia, School of Nursing, McLeod Hall 4034, 225 Jeanette Lancaster Way, Charlottesville, VA 22903, United States. Electronic address: xl5tb@virginia.edu.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Farber', 'Affiliation': 'University of Virginia, Public Health Sciences, OMS 3817B, Charlottesville, VA 22908, United States. Electronic address: crf2s@virginia.edu.'}, {'ForeName': 'Zhenqi', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'University of Virginia, School of Medicine, Suite 2100, 450 Ray C. Hunt Drive, Charlottesville, VA 22903, United States. Electronic address: zl3e@virginia.edu.'}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Annex', 'Affiliation': 'Augusta University, Medical College of Georgia, 1120 15th St. Augusta, GA 30912, United States. Electronic address: bannex@augusta.edu.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.06.015']
1018,32620810,Effect of occlusal splint on oxidative stress markers and psychological aspects of chronic temporomandibular pain: a randomized controlled trial.,"Temporomandibular disorders (TMD), when progress to a chronic state, might contribute to psychosocial or psychological distress. This study aimed to evaluate the effect of stabilization splint (SS) therapy on pain, pain-related disability and psychological traits of chronic TMD patients, as well as to assess selected oxidative stress (OS) biomarkers during 6-month treatment and associate them with the symptoms of anxiety and depression. Thirty-four participants were randomly assigned into two treatment groups [SS and placebo splint (PS)]. Primary outcomes were pain intensity and pain-related disability while secondary outcomes included depressive and anxiety symptoms. The influence of the treatment type was analyzed with regards to the levels of OS biomarkers in saliva. Participants treated with SS demonstrated significantly greater improvement in pain-related disability (Pain-free mouth opening: p = 0.018, η 2  = 0.166; Number of disability days: p = 0.023, η 2  = 0.155) and greater reduction of depressive symptoms scores (p = 0.007, η 2  = 0.207). When compared to the PS group, participants in the SS group showed a significant reduction of oxidant/antioxidant ratio (p = 0.018, η 2  = 0.167) at a 3-month follow-up. A stabilization splint provides advantages over PS in the treatment of depressive symptoms and pain-related disability. Furthermore, clinical success in terms of reduction of depressive symptoms, which correlates with the reduction of oxidative stress markers in the SS group, indicates that oxidative stress is related to psychological factors in chronic TMD patients.",2020,"Participants treated with SS demonstrated significantly greater improvement in pain-related disability (Pain-free mouth opening: p = 0.018, η 2  = 0.166; Number of disability days: p = 0.023, η 2  = 0.155) and greater reduction of depressive symptoms scores (p = 0.007, η 2  = 0.207).","['Thirty-four participants', 'chronic temporomandibular pain', 'chronic TMD patients', 'Temporomandibular disorders (TMD']","['occlusal splint', 'stabilization splint (SS) therapy', 'SS', 'placebo splint (PS', 'stabilization splint']","['oxidative stress markers', 'depressive symptoms scores', 'pain intensity and pain-related disability', 'oxidative stress (OS) biomarkers', 'depressive and anxiety symptoms', 'pain, pain-related disability and psychological traits', 'pain-related disability', 'oxidant/antioxidant ratio']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",34.0,0.0633455,"Participants treated with SS demonstrated significantly greater improvement in pain-related disability (Pain-free mouth opening: p = 0.018, η 2  = 0.166; Number of disability days: p = 0.023, η 2  = 0.155) and greater reduction of depressive symptoms scores (p = 0.007, η 2  = 0.207).","[{'ForeName': 'Iva Z', 'Initials': 'IZ', 'LastName': 'Alajbeg', 'Affiliation': 'Department of Removable Prosthodontics, School of Dental Medicine, University of Zagreb, Gundulićeva 5, 10 000, Zagreb, Croatia.'}, {'ForeName': 'Ema', 'Initials': 'E', 'LastName': 'Vrbanović', 'Affiliation': 'Department of Removable Prosthodontics, School of Dental Medicine, University of Zagreb, Gundulićeva 5, 10 000, Zagreb, Croatia. evrbanovic@sfzg.hr.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Lapić', 'Affiliation': 'Medical Biochemistry and Laboratory Medicine, Department of Laboratory Diagnostics, University Hospital Centre Zagreb (KBCZ), Zagreb, Croatia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Alajbeg', 'Affiliation': 'Department of Oral Medicine, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Vuletić', 'Affiliation': 'Department of Physiology, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}]",Scientific reports,['10.1038/s41598-020-67383-x']
1019,32624282,"Erratum to 'Ten-year Mortality, Disease Progression, and Treatment-related Side Effects in Men with Localised Prostate Cancer from the ProtecT Randomised Controlled Trial According to Treatment Received' [European Urology 77 (2020) 320-330].",,2020,,['Men with Localised Prostate Cancer'],[],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",[],[],,0.0635376,,"[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Neal', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK Professor Emeritus of Surgical Oncology, Universities of Cambridge and Oxford, UK. Electronic address: David.Neal@nds.ox.ac.uk.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eleanor I', 'Initials': 'EI', 'LastName': 'Walsh', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Mason', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bryant', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Bollina', 'Affiliation': 'Department of Urology & Surgery, Western General Hospital, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Catto', 'Affiliation': 'Academic Urology Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Doherty', 'Affiliation': 'Department of Urology, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillatt', 'Affiliation': 'Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gnanapragasam', 'Affiliation': 'Academic Urology Group, Department of Surgery & Cambridge Urology Translational Research and Clinical Trials, Cambridge Biomedical Campus, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Holding', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK Professor Emeritus of Surgical Oncology, Universities of Cambridge and Oxford, UK.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Hughes', 'Affiliation': 'Department of Urology, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Kockelbergh', 'Affiliation': 'Department of Urology, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Kynaston', 'Affiliation': 'Division of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Oxley', 'Affiliation': 'Department of Cellular Pathology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Paul', 'Affiliation': 'Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Paez', 'Affiliation': 'Department of Urology, Freeman Hospital, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Rosario', 'Affiliation': 'Department of Urology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Rowe', 'Affiliation': 'Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'Division of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Doug G', 'Initials': 'DG', 'LastName': 'Altman', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Freddie C', 'Initials': 'FC', 'LastName': 'Hamdy', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK Professor Emeritus of Surgical Oncology, Universities of Cambridge and Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2020.05.030']
1020,32633157,Wound healing adverse events in kidney transplant recipients receiving everolimus with reduced calcineurin inhibitor exposure or current standard-of-care: insights from the 24-month TRANSFORM study.,"OBJECTIVES


In TRANSFORM,  de novo  kidney transplant recipients received either everolimus in combination with reduced-exposure calcineurin inhibitor (EVR+rCNI) at standard EVR pre-dose concentrations of 3-8 ng/mL or mycophenolic acid plus standard-exposure CNI (MPA+sCNI). The authors analyzed the incidence of wound healing adverse events (WHAEs) over the 2-year study period 15.
METHODS


Patients were randomized to either EVR+rCNI or MPA+sCNI, both combined with induction therapy and steroids 19.
RESULTS


The safety population consisted of 2,026 patients (EVR+rCNI: 1,014, MPA+sCNI: 1,012). The proportion of patients with at least 1 WHAE was comparable between EVR+rCNI and MPA+sCNI treatment groups [20.6% vs. 17.3%; risk ratio (RR): 1.19; 95% confidence interval (CI): 0.99, 1.43] at month 24. The numerical difference between EVR+rCNI and MPA+sCNI was mainly caused by an increased proportion of EVR patients with lymphocele and wound dehiscence [7.5% vs. 5.1% (RR: 1.46; 95% CI: 1.04, 2.05) and 3.9% vs. 1.8% (RR: 2.22; 95%CI: 1.28, 3.84), respectively] 20.
CONCLUSION


The immediate introduction of EVR+rCNI after kidney transplantation was associated with an overall comparable incidence of WHAEs versus current standard-of-care over the 24-month study period. There was an increased relative risk of experiencing lymphocele and wound dehiscence but the absolute risks were rather low in both groups 21.
CT.GOV IDENTIFIER


NCT01950819.",2020,"There was an increased relative risk of experiencing lymphocele and wound dehiscence but the absolute risks were rather low in both groups.
","['2,026 patients (EVR+rCNI: 1,014, MPA+sCNI: 1,012', 'kidney transplant recipients receiving everolimus with reduced calcineurin inhibitor exposure or current standard-of-care', 'Patients']","['everolimus in combination with reduced-exposure calcineurin inhibitor (EVR+rCNI', 'EVR+rCNI', 'EVR+rCNI or MPA+sCNI, both combined with induction therapy and steroids', 'mycophenolic acid plus standard-exposure CNI (MPA+sCNI']","['proportion of EVR patients with lymphocele and wound dehiscence', 'relative risk of experiencing lymphocele and wound dehiscence', 'Wound healing adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1431767', 'cui_str': 'cni protein, Drosophila'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024248', 'cui_str': 'Lymphocele'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2026.0,0.0583234,"There was an increased relative risk of experiencing lymphocele and wound dehiscence but the absolute risks were rather low in both groups.
","[{'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Citterio', 'Affiliation': 'Department of Surgery, Fondazione Policlinico Universitario A. Gemelli, IRCCS , Rome, Italy.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Henry', 'Affiliation': 'Department of Surgery, The Comprehensive Transplant Center, The Ohio State University, Wexner Medical Center , Columbus, OH, USA.'}, {'ForeName': 'Dean Y', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Department of Transplant and Hepatobiliary Surgery, Henry Ford Hospital , Detroit, USA.'}, {'ForeName': 'Myoung Soo', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Yonsei University College of Medicine , Seoul, Republic of Korea.'}, {'ForeName': 'Duck-Jong', 'Initials': 'DJ', 'LastName': 'Han', 'Affiliation': 'Department of Surgery, Asan Medical Center , Seoul, Republic of South Korea.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kenmochi', 'Affiliation': 'Department of Transplant Surgery, Fujita Health University , Toyoake, Japan.'}, {'ForeName': 'Eytan', 'Initials': 'E', 'LastName': 'Mor', 'Affiliation': 'Department of Surgery, Transplant Center at Sheba Medical Center , Ramat-Gan, Israel.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tisone', 'Affiliation': 'Department of Surgery HPB and Transplant Unit, University of Tor Vergata , Rome, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bernhardt', 'Affiliation': 'Department of Research and Development, Novartis Pharma AG , Basel, Switzerland.'}, {'ForeName': 'Maria Pilar', 'Initials': 'MP', 'LastName': 'Hernandez Gutierrez', 'Affiliation': 'Department of Research and Development, Novartis Pharma AG , Basel, Switzerland.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Watarai', 'Affiliation': 'Department of Transplant Surgery and Nephrology, Nagoya Daini Red Cross Hospital , Nagoya-City, Japan.'}]",Expert opinion on drug safety,['10.1080/14740338.2020.1792441']
1021,32636109,Repeat Doses of Dexamethasone up to 48 Hours Further Reduce Pain and Inflammation After Total Hip Arthroplasty: A Randomized Controlled Trial.,"BACKGROUND


The optimal dose regimen of dexamethasone in total hip arthroplasty (THA) is unclear. This study was conducted to compare the effects among 1-dose, 2-dose, and 3-dose dexamethasone in THA.
METHODS


One hundred fifty patients were randomized to receive a single preoperative dose of 10-mg dexamethasone (group A, 50 patients), or another dose of 10-mg dexamethasone 24 hours later (group B, 50 patients), or another 2 doses of 10-mg dexamethasone 24 and 48 hours later (group C, 50 patients). The primary outcome was postoperative pain level. The use of analgesic and antiemetic rescue; incidence of postoperative nausea and vomiting; C-reactive protein and interleukin-6 levels; range of motion; and complications were also compared.
RESULTS


The dynamic pain scores were lower for groups B and C compared to group A on postoperative days 2 and 3. Such difference was also detected between groups B and C on postoperative day 3. C-reactive protein and interleukin-6 levels were lower in groups B and C than in group A at 48 and 72 hours postoperatively. Such difference was also observed between groups B and C at 72 hours postoperatively. Patients in groups B and C had reduced rescue analgesic use, and improved range of motion compared to patients in group A. There were no differences among 3 groups regarding the rescue antiemetic use, postoperative nausea and vomiting occurrence, and complications.
CONCLUSION


Additional administrations of dexamethasone after THA could provide sustained pain relief and inflammatory control. Besides, the 3-dose regimen was more effective than the 2-dose regimen in terms of the analgesic and anti-inflammatory effects.
LEVEL OF EVIDENCE


I.",2020,C-reactive protein and interleukin-6 levels were lower in groups B and C than in group A at 48 and 72 hours postoperatively.,"['After Total Hip Arthroplasty', 'total hip arthroplasty (THA', 'One hundred fifty patients']","['dexamethasone', 'Dexamethasone', '10-mg dexamethasone']","['dynamic pain scores', 'postoperative pain level', 'rescue antiemetic use, postoperative nausea and vomiting occurrence, and complications', 'C-reactive protein and interleukin-6 levels', 'Pain and Inflammation', 'sustained pain relief and inflammatory control', 'range of motion']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",150.0,0.182866,C-reactive protein and interleukin-6 levels were lower in groups B and C than in group A at 48 and 72 hours postoperatively.,"[{'ForeName': 'Yiting', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, People's Republic of China; Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Zeyu', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Fuxing', 'Initials': 'F', 'LastName': 'Pei', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}]",The Journal of arthroplasty,['10.1016/j.arth.2020.06.023']
1022,32647911,Single-Inhaler Triple Therapy and Health-Related Quality of Life in COPD: The IMPACT Study.,"INTRODUCTION


The phase 3 InforMing the PAthway of COPD (chronic obstructive pulmonary disease) Treatment (IMPACT) trial, single-inhaler therapy with fluticasone furoate (FF) 100 μg, umeclidinium (UMEC) 62.5 μg, and vilanterol (VI) 25 μg demonstrated a reduction in the rate of moderate or severe exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic COPD at risk of exacerbations. This article reports additional evidence of improvements in symptoms and health-related quality of life (HRQoL) with FF/UMEC/VI compared with either FF/VI or UMEC/VI from the IMPACT study.
METHODS


Patient-reported HRQoL assessments and symptom measures included as pre-specified IMPACT end points were the St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Baseline Dyspnea Index (BDI) as the anchor for the Transitional Dyspnea Index (TDI) focal score (BDI/TDI) in a subset of patients enrolled at study sites in North America and Europe. Change from baseline was assessed at weeks 4, 28, and 52.
RESULTS


The intent-to-treat population included 10,355 patients (TDI population: 5058 patients). Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI (- 1.8 units, p < 0.001) and UMEC/VI (- 1.8 units, p < 0.001). Similar improvements in the CAT and TDI focal score were also observed with FF/UMEC/VI versus FF/VI or UMEC/VI.
CONCLUSIONS


This study demonstrates that in patients with symptomatic COPD at risk of exacerbations, once-daily FF/UMEC/VI, compared with FF/VI or UMEC/VI, improves patient-perceived HRQoL and symptoms.
TRIAL REGISTRATION NUMBER


NCT02164513.",2020,Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI,"['10,355 patients (TDI population: 5058 patients', 'COPD', 'patients enrolled at study sites in North America and Europe', 'patients with symptomatic COPD at risk of exacerbations']","['fluticasone furoate (FF) 100\xa0μg, umeclidinium (UMEC) 62.5\xa0μg, and vilanterol (VI']","[""St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Baseline Dyspnea Index (BDI) as the anchor for the Transitional Dyspnea Index (TDI) focal score (BDI/TDI"", 'SGRQ total score', 'rate of moderate or severe exacerbations', 'CAT and TDI focal score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",10355.0,0.664861,Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI,"[{'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Tabberer', 'Affiliation': 'GlaxoSmithKline plc, Stockley Park West, Uxbridge, Middlesex, UK. margaret.x.tabberer@gsk.com.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'GlaxoSmithKline plc, Research Triangle Park, NC, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'GlaxoSmithKline plc, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Pascoe', 'Affiliation': 'GlaxoSmithKline plc, Collegeville, PA, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'The Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'The Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'The Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'University of Michigan, Pulmonary and Critical Care, Ann Arbor, MI, USA.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Morrys C', 'Initials': 'MC', 'LastName': 'Kaisermann', 'Affiliation': 'GlaxoSmithKline plc, Collegeville, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline plc, Collegeville, PA, USA.'}]",Advances in therapy,['10.1007/s12325-020-01409-8']
1023,32646498,"Tofogliflozin does not delay progression of carotid atherosclerosis in patients with type 2 diabetes: a prospective, randomized, open-label, parallel-group comparative study.","BACKGROUND


This study aimed to investigate the preventive effects of tofogliflozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, on atherosclerosis progression in type 2 diabetes (T2DM) patients without apparent cardiovascular disease (CVD) by monitoring carotid intima-media thickness (IMT).
METHODS


This prospective, randomized, open-label, blinded-endpoint, multicenter, parallel-group, comparative study included 340 subjects with T2DM and no history of apparent CVD recruited at 24 clinical units. Subjects were randomly allocated to either the tofogliflozin treatment group (n = 169) or conventional treatment group using drugs other than SGLT2 inhibitors (n = 171). Primary outcomes were changes in mean and maximum common carotid IMT measured by echography during a 104-week treatment period.
RESULTS


In a mixed-effects model for repeated measures, the mean IMT of the common carotid artery (mean-IMT-CCA), along with the right and left maximum IMT of the CCA (max-IMT-CCA), significantly declined in both the tofogliflozin (- 0.132 mm, SE 0.007; - 0.163 mm, SE 0.013; - 0.170 mm, SE 0.020, respectively) and the control group (- 0.140 mm, SE 0.006; - 0.190 mm, SE 0.012; - 0.190 mm, SE 0.020, respectively). Furthermore, the tofogliflozin and the conventional treatment group did not significantly differ in the progression of the mean-IMT-CCA (mean change (95% CI) 0.008 (- 0.009, 0.025) mm, P = 0.34), along with the right (mean change (95% CI) 0.027 (- 0.005, 0.059) mm, P = 0.10) and the left max-IMT-CCA (mean change (95% CI) 0.020 (- 0.030, 0.070), P = 0.43). Similar findings were obtained even after adjusting for traditional CV risk factors and/or administration of drugs at baseline. Relative to the control treatment effects, tofogliflozin significantly reduced the HbA1c, blood glucose level, body weight/body mass index, abdominal circumference, and systolic blood pressure, and significantly increased the HDL-C. The total and serious adverse events incidences did not significantly vary between the treatment groups.
CONCLUSIONS/INTERPRETATION


No IMT changes were observed between the tofogliflozin and the conventional treatment groups. However, tofogliflozin is a safe and effective treatment option for managing primary CVD risk factors in this population. Clinical Trial Registration UMIN000017607 ( https://www.umin.ac.jp/icdr/index.html ).",2020,"Relative to the control treatment effects, tofogliflozin significantly reduced the HbA1c, blood glucose level, body weight/body mass index, abdominal circumference, and systolic blood pressure, and significantly increased the HDL-C.","['340 subjects with T2DM and no history of apparent CVD recruited at 24 clinical units', 'type 2 diabetes (T2DM) patients without apparent cardiovascular disease (CVD) by monitoring carotid intima-media thickness (IMT', 'patients with type 2 diabetes']","['tofogliflozin', 'Tofogliflozin', 'tofogliflozin treatment group (n\u2009=\u2009169) or conventional treatment group using drugs other than SGLT2 inhibitors', 'tofogliflozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor']","['carotid atherosclerosis', 'changes in mean and maximum common carotid IMT', 'HbA1c, blood glucose level, body weight/body mass index, abdominal circumference, and systolic blood pressure, and significantly increased the HDL-C', 'progression of the mean-IMT-CCA', 'mean IMT of the common carotid artery', 'left max-IMT-CCA', 'IMT changes', 'total and serious adverse events incidences']","[{'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0220668', 'cui_str': 'Congenital contractural arachnodactyly'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",340.0,0.0458559,"Relative to the control treatment effects, tofogliflozin significantly reduced the HbA1c, blood glucose level, body weight/body mass index, abdominal circumference, and systolic blood pressure, and significantly increased the HDL-C.","[{'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Katakami', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. katakami@endmet.med.osaka-u.ac.jp.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Mita', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Hongo 2-1-1, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Yoshii', 'Affiliation': 'Department of Medicine, Diabetology & Endocrinology, Juntendo Tokyo Koto Geriatric Medical Center, Koto-ku, Tokyo, 136-0075, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Shiraiwa', 'Affiliation': 'Shiraiwa Medical Clinic, 4-10-24 Hozenji, Kashiwara City, Osaka, 582-0005, Japan.'}, {'ForeName': 'Tetsuyuki', 'Initials': 'T', 'LastName': 'Yasuda', 'Affiliation': 'Department of Diabetes and Endocrinology, Osaka Police Hospital, 10-31, Kitayama-cho, Tennoji-ku, Osaka, 543-0035, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Torimoto', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Umayahara', 'Affiliation': 'Department of Diabetes and Endocrinology, Osaka General Medical Center, 3-1-56, Bandai-Higashi, Sumiyoshi-ku, Osaka, 558-8558, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kaneto', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Osonoi', 'Affiliation': 'Nakakinen Clinic, 745-5, Nakadai, Naka City, Ibaraki, 311-0113, Japan.'}, {'ForeName': 'Tsunehiko', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Diabetes and Endocrinology, Kansai Rosai Hospital, 3-1-69, Inabaso, Amagasaki City, Hyogo, Japan.'}, {'ForeName': 'Nobuichi', 'Initials': 'N', 'LastName': 'Kuribayashi', 'Affiliation': 'Misaki Naika Clinic, 6-44-9, Futawa-higashi, Funabashi City, Chiba, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'Kitasenri Maeda Clinic, 4-119 Furuedai, Suita, Osaka, 565-0874, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yokoyama', 'Affiliation': 'Jiyugaoka Medical Clinic, West 6, South 6-4-3, Obihiro, Hokkaido, 080-0016, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Kosugi', 'Affiliation': 'Kosugi Medical Clinic, 3-9, Tamatsukurimoto-cho, Tennoji-ku, Osaka, 543-0014, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ohtoshi', 'Affiliation': 'Otoshi Medical Clinic, 8-47, Kakudacho, Osaka Kita-ku, Osaka, 530-0017, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Hayashi', 'Affiliation': 'Hayashi Clinic, 3-9-23 Koshienguchi, Nishinomiya, Hyogo, 663-8113, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Sumitani', 'Affiliation': 'Center for Diabetes and Endocrinology, Nippon Life Hospital, 2-1-54 Enokojima, Nishi-ku, Osaka, 550-0006, Japan.'}, {'ForeName': 'Mamiko', 'Initials': 'M', 'LastName': 'Tsugawa', 'Affiliation': 'Department of Endocrinology and Metabolism, Ikeda Municipal Hospital, 3-1-18, Jonan, Ikeda, Osaka, 563-8510, Japan.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Ryomoto', 'Affiliation': 'Center for Diabetes Mellitus, Osaka Rosai Hospital, 1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, 591-8025, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Taki', 'Affiliation': 'Diabetes Center, National Hospital Organization Osaka National Hospital, 2-1-14, Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Department of Internal Medicine, Kawasaki Hospital, 3-3-1, Higashiyamacho, Kobe Hyogo-ku, Hyogo, 652-0042, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kawashima', 'Affiliation': 'Kanda Naika Clinic, 5-21-3, Hannancho, Osaka Abeno-ku, Osaka, 545-0021, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, 45 Shinanomachi Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Hongo 2-1-1, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Iichiro', 'Initials': 'I', 'LastName': 'Shimomura', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular diabetology,['10.1186/s12933-020-01079-4']
1024,32649961,The effect of platelet-rich plasma on female androgenetic alopecia: A randomized controlled trial.,"BACKGROUND


Platelet-rich plasma (PRP) may be a useful treatment for androgenetic alopecia (AGA), although objective studies are needed.
OBJECTIVE


To determine whether PRP injections improve female AGA.
METHOD


Prospective randomized controlled trial of 30 women diagnosed with AGA. Patients received subdermal scalp injections of Eclipse system PRP or placebo saline at weeks 0, 4, and 8. Outcome measures were changes in hair density (hair/cm 2 ), hair caliber (mm), and blinded global photographic assessment (improved or not improved) at week 24.
RESULTS


Blinded global photographic assessment indicated that 57% of patients receiving PRP versus 7% of patients receiving saline improved at week 24 from baseline (P < .01). Compared to baseline, there was improvement in mean density in the PRP group versus the placebo group at week 8 (+71.1 vs -26.7 hairs/cm 2 ; P < .01) and week 24 (+105.9 vs -52.4 hairs/cm 2 ; P < .01). Compared to baseline, there was improvement in mean caliber in the PRP group versus the placebo group at week 8 (+0.0043 vs -0.0034 mm; P < .01) and week 24 (+0.0053 vs -0.0060 mm; P < .01). Adverse effects included headache, scalp tightness, swelling, redness, and postinjection bleeding.
LIMITATIONS


Two patients lost to follow-up.
CONCLUSIONS


PRP with the Eclipse system is a safe and effective intervention for female AGA.",2020,"Compared to baseline, there was improvement in mean caliber in the PRP group vs. the placebo group at week 8 (+0.0043 vs. -0.0034 mm, p<0.01) and week 24 (+0.0053 vs. -0.0060 mm, p<0.01).","['30 females diagnosed with AGA', 'female androgenetic alopecia', 'androgenetic alopecia (AGA']","['subdermal scalp injections of Eclipse system PRP or placebo saline', 'PRP injections', 'platelet-rich plasma', 'placebo']","['mean caliber', 'headache, scalp tightness, swelling, redness, and post-injection bleeding', 'mean density', 'changes in hair density (hair/cm 2 ), hair caliber (mm), and blinded global photographic assessment']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}]","[{'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",30.0,0.356908,"Compared to baseline, there was improvement in mean caliber in the PRP group vs. the placebo group at week 8 (+0.0043 vs. -0.0034 mm, p<0.01) and week 24 (+0.0053 vs. -0.0060 mm, p<0.01).","[{'ForeName': 'Danielle P', 'Initials': 'DP', 'LastName': 'Dubin', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: DPDubin121@gmail.com.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Lin', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Hayley M', 'Initials': 'HM', 'LastName': 'Leight', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Aaron S', 'Initials': 'AS', 'LastName': 'Farberg', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York; Arkansas Dermatology, Little Rock, Arkansas.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Torbeck', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Burton', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Khorasani', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.06.1021']
1025,32650033,Effect of clinical inertia and trial participation in younger and older adults with diabetes having comorbidities and progressive complications.,"AIM


Clinical inertia is a multifactorial phenomenon, with contributing factors from people with diabetes and their healthcare team. It is widely cited that clinical inertia is minimised by participation in clinical trials. We assessed whether trial participation per se improves metabolic parameters in people with diabetes, or a specific focus on glycaemia is required.
METHODS


We compared improvement in glycaemic control in a pooled set of people assigned to the ""placebo"" arm from 25 glycaemia-focused trials with a pooled group of people with diabetes allocated to sham or non-pharmacological intervention for the treatment of diabetic retinal disease. Mean change in HbA1c (ANCOVA) was evaluated.
RESULTS


The overall placebo effect in studies focused on glucose control (N = 3081) was comparable between strata groups with and without complications. Adjusted least square mean change in HbA1c at 24 weeks was between -0.23% (-2.50 mmol/mol) and -0.32% (-3.50 mmol/mol). In studies focused on retinal disease (N = 288), the change from baseline in HbA1c was +0.10% (1.10 mmol/mol) and fasting plasma glucose was +0.50 mmol/L showing no improvement in metabolic parameters at 12 months.
CONCLUSIONS


Clinical trial participation alone does not seem to improve metabolic parameters in people living with diabetes. The benefits observed in glycaemia-focused studies were independent of age and comorbidities.",2020,The overall placebo effect in studies focused on glucose control (N=3081) was comparable between strata groups with and without complications.,"['people with diabetes and their healthcare team', 'people with diabetes', 'younger and older adults with diabetes having comorbidities and progressive complications', 'people living with diabetes']","['sham or non-pharmacological intervention', 'placebo']","['metabolic parameters', 'fasting plasma glucose', 'Mean change in HbA1c (ANCOVA']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086390', 'cui_str': 'Health Care Team'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.202893,The overall placebo effect in studies focused on glucose control (N=3081) was comparable between strata groups with and without complications.,"[{'ForeName': 'William David', 'Initials': 'WD', 'LastName': 'Strain', 'Affiliation': 'University of Exeter Medical School, Exeter, United Kingdom; Academic Department of Healthcare for the Elderly, Royal Devon & Exeter NHS Foundation Trust, Exeter, United Kingdom. Electronic address: d.strain@exeter.ac.uk.'}, {'ForeName': 'Päivi Maria', 'Initials': 'PM', 'LastName': 'Paldánius', 'Affiliation': ""Children's Hospital, Helsinki University Hospital, Helsinki, Finland; Program for Clinical and Molecular Metabolism, Helsinki University, Helsinki, Finland.""}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108310']
1026,32661522,Comparative clinical and radiographic evaluation of demineralized freeze-dried bone allograft with and without decortication in the treatment of periodontal intrabony defects: a randomized controlled clinical study.,"OBJECTIVES


Regeneration of intrabony defects is a challenging target of periodontal therapy. The biologic rationale for regeneration not only is based on incorporating the regenerative material, but also takes into consideration the defect's inherent healing capacity. The present study was carried out to evaluate the efficacy of decortication or intramarrow penetration performed with demineralized freeze-dried bone allograft (DFDBA) in the management of intrabony defects.
METHOD AND MATERIALS


Forty chronic periodontitis (stage II and III periodontitis) patients having 40 intrabony defects were randomly assigned into test group (intrabony defect filled with DFDBA after intramarrow penetration along with open flap debridement [OFD+IMP+ DFDBA]) and control group (DFDBA along with open flap debridement [OFD+DFDBA]). Primary outcome measures included probing pocket depth, clinical attachment level, and percentage bone fill (%BF). All parameters were recorded at baseline, 6 months, and 9 months postsurgical follow-up.
RESULTS


Mean reduction in probing depth and gain in clinical attachment level was statistically significantly higher at the interdental defect site in the test group compared to the control group at 9 months follow-up (P = .02 and .04, respectively). In radiographic parameters, statistically significant improvements in defect depth and gain in defect area were found in the test group (P = .00 and .03, respectively). Statistically significant improvements in %BF and linear bone growth (P = .02 and .00, respectively) were also observed in the experimental group (39.47 ± 13.92% and 1.41 ± 0.54 mm) in comparison with the control group (19.29 ± 14.24%, 0.62 ± 0.49 mm).
CONCLUSION


Addition of intramarrow penetration with DFDBA in surgical periodontal therapy may enhance the healing potential of periodontal intrabony defects, as observed by greater improvement in clinical and radiographic outcomes.",2020,"RESULTS


Mean reduction in probing depth and gain in clinical attachment level was statistically significantly higher at the interdental defect site in the test group compared to the control group at 9 months follow-up (P = .02 and .04, respectively).","['Forty chronic periodontitis (stage II and III periodontitis) patients having 40 intrabony defects', 'periodontal intrabony defects']","['demineralized freeze-dried bone allograft (DFDBA', 'demineralized freeze-dried bone allograft with and without decortication', 'test group (intrabony defect filled with DFDBA after intramarrow penetration along with open flap debridement [OFD+IMP+ DFDBA]) and control group (DFDBA along with open flap debridement [OFD+DFDBA']","['healing potential of periodontal intrabony defects', 'BF and linear bone growth', 'probing pocket depth, clinical attachment level, and percentage bone fill (%BF', 'defect depth and gain in defect area', 'probing depth and gain in clinical attachment level']","[{'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}]","[{'cui': 'C0016698', 'cui_str': 'Lyophilization'}, {'cui': 'C0407564', 'cui_str': 'Allogeneic bone graft'}, {'cui': 'C0007778', 'cui_str': 'Brain decortication'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0971859', 'cui_str': 'Bone Growth'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",40.0,0.0385302,"RESULTS


Mean reduction in probing depth and gain in clinical attachment level was statistically significantly higher at the interdental defect site in the test group compared to the control group at 9 months follow-up (P = .02 and .04, respectively).","[{'ForeName': 'Amanpreet Kaur', 'Initials': 'AK', 'LastName': 'Saini', 'Affiliation': ''}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Tewari', 'Affiliation': ''}, {'ForeName': 'Satish Chander', 'Initials': 'SC', 'LastName': 'Narula', 'Affiliation': ''}, {'ForeName': 'Rajinder Kumar', 'Initials': 'RK', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Nishi', 'Initials': 'N', 'LastName': 'Tanwar', 'Affiliation': ''}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Sangwan', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a44921']
1027,32667383,"Effectiveness of kinesio taping on postoperative morbidity after impacted mandibular third molar surgery: a prospective, randomized, placebo-controlled clinical study.","Objective Our study seeks to investigate the effectiveness of kinesio taping (KT) on postoperative morbidity compared to placebo and control groups after impacted third molar surgery. Methodology Sixty patients with impacted mandibular third molar were included in this prospective, randomized, placebo-controlled clinical study. After surgical extraction of the impacted tooth, patients were allocated into three groups (20 patients each): group 1 received KT (kinesio), group 2 received placebo taping (placebo), and group 3 received no taping (control). The groups were compared regarding facial swelling, pain and trismus. Swelling was evaluated using a tape measuring method. Pain was assessed by a visual analog scale and the number of analgesic tablets taken. Trismus was determined by measuring maximum mouth opening. Results In the KT group, all parameters reduced significantly on 2nd and 4th postoperative days compared to other groups; however, placebo and control groups revealed comparable outcomes. On 7th day, all groups showed comparable results. Conclusions The KT application is an effective method for reducing morbidity after impacted mandibular third molar surgery. However, placebo taping is not as effective as proper taping. Placebo taping shows similar results compared to no taping regarding facial swelling percentage, pain and trismus.",2020,"In the KT group, all parameters reduced significantly on 2nd and 4th postoperative days compared to other groups; however, placebo and control groups revealed comparable outcomes.","['after impacted mandibular third molar surgery', 'Methodology Sixty patients with impacted mandibular third molar', 'and control groups after impacted third molar surgery']","['kinesio taping (KT', 'Placebo', 'kinesio taping', 'placebo taping (placebo), and group 3 received no taping (control', 'KT (kinesio', 'placebo']","['visual analog scale and the number of analgesic tablets taken', 'Swelling', 'Pain', 'postoperative morbidity', 'facial swelling percentage, pain and trismus', 'morbidity', 'Trismus', 'facial swelling, pain and trismus']","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling'}]",60.0,0.249748,"In the KT group, all parameters reduced significantly on 2nd and 4th postoperative days compared to other groups; however, placebo and control groups revealed comparable outcomes.","[{'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Tatli', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Ilke Coskun', 'Initials': 'IC', 'LastName': 'Benlidayi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, School of Medicine, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Fariz', 'Initials': 'F', 'LastName': 'Salimov', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Rengin', 'Initials': 'R', 'LastName': 'Guzel', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, School of Medicine, Cukurova University, Adana, Turkey.'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2020-0159']
1028,32669215,Effect of Puppet Show on Children's anxiety and pain levels during the circumcision operation: A randomized controlled trial.,"INTRODUCTION


Surgical procedures are the most common causes of anxiety and pain in hospitalized children. One of the most common surgical procedures for children is circumcision. Surgical procedures such as circumcision in hospitals are the most common causes of pain, fear, and anxiety in children. Therapeutic play methods as non-pharmacological applications are being developed recently for children who use analgesics in the treatment of pain and anxiety. Nurses can use the game in three areas such as a care strategy for hospitalized children during daily routine practices, surgery, and invasive or painful treatment procedures. An extensive literature review revealed that there were therapeutic game plays performed before and after the surgical procedure. Nonetheless, no therapeutic game play performed during the surgical procedure were reported. In addition, no reported study of puppet show which is one of the therapeutic game methods were found.
OBJECTIVE


The aim of this study was to investigate the effect of the puppet show demonstrated to 7-11 years old children during circumcision on the anxiety and pain level of children.
DESIGN


The study was designed as a randomized controlled experiment.
MATERIALS AND METHODS


The population of the study was the children between 7 and 11 years of old and being circumcised in the urology clinic at Research and Training Hospital in Karabük Turkey between 1 May and 1 September 2017. A total of 81 (experimental group: 40, control group: 41) children were included in the study. ""Participant Information Form"", ""Wong Baker Faces Pain Rating Scale"" and ""State-Trait Anxiety Inventory for Children"" were used as implemented in the literature.
RESULTS


The median pain score of the experimental group during and after the procedure was statistically lower than the control group. The level of anxiety during and after the procedure in the experimental group showed a statistically significant decrease compared to the pre-treatment level and the level of anxiety after the procedure showed a statistically significant decrease compared to the procedure. In the control group, while the level of anxiety during the procedure showed a statistically significant increase compared to the pre-treatment level, the level of anxiety after the procedure showed a statistically significant decrease compared to the one during the procedure.
CONCLUSION


It was concluded that the puppet show performed during the circumcision procedure was effective in reducing the pain and anxiety that developed during the circumcision and continued after the procedure.",2020,The level of anxiety during and after the procedure in the experimental group showed a statistically significant decrease compared to the pre-treatment level and the level of anxiety after the procedure showed a statistically significant decrease compared to the procedure.,"['children between 7 and 11 years of old and being circumcised in the urology clinic at Research and Training Hospital in Karabük Turkey between 1 May and 1 September 2017', 'hospitalized children during daily routine practices, surgery, and invasive or painful treatment procedures', '7-11 years old children during circumcision on the anxiety and pain level of children', 'hospitalized children', 'children who use analgesics in the treatment of pain and anxiety', 'A total of 81 (experimental group: 40, control group: 41) children were included in the study. ']",['Puppet'],"['median pain score', 'level of anxiety', ""Children's anxiety and pain levels"", 'Participant Information Form"", ""Wong Baker Faces Pain Rating Scale"" and ""State-Trait Anxiety Inventory', 'pain and anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0920194', 'cui_str': 'Circumcised'}, {'cui': 'C3812395', 'cui_str': 'Urology clinic'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0034125', 'cui_str': 'Puppets'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0332306,The level of anxiety during and after the procedure in the experimental group showed a statistically significant decrease compared to the pre-treatment level and the level of anxiety after the procedure showed a statistically significant decrease compared to the procedure.,"[{'ForeName': 'Özge Karakaya', 'Initials': 'ÖK', 'LastName': 'Suzan', 'Affiliation': 'Department of Pediatric Nursing, Faculty of Health Sciences, University of Sakarya, Esentepe Campus, 54187, Turkey. Electronic address: ozgekarakayasuzan@sakarya.edu.tr.'}, {'ForeName': 'Özlem Öztürk', 'Initials': 'ÖÖ', 'LastName': 'Şahin', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Karabuk University, Demir-Celik Kampusu, 78050, Karabuk, Turkey. Electronic address: zlemzturk@hotmail.com.'}, {'ForeName': 'Özer', 'Initials': 'Ö', 'LastName': 'Baran', 'Affiliation': 'Department of Urology, Faculty of Medical, Karabuk University, Demir-Celik Kampusu, 78050, Karabuk, Turkey. Electronic address: ozerbaran@karabuk.edu.tr.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.06.016']
1029,32679537,Blood pressure postpartum (BP 2 ) RCT protocol: Follow-up and lifestyle behaviour change strategies in the first 12 months after hypertensive pregnancy.,"OBJECTIVES


Women who had hypertensive disorders of pregnancy (HDP) are twice as likely to experience maternal cardiovascular disease later in life. The primary aim of this study (BP 2 ) is to compare outcomes of 3 different management strategies, including lifestyle behaviour change (LBC), in the first 12 months postpartum in women who had HDP in their preceding pregnancy. Secondary aims include assessing the effects on other cardiometabolic parameters.
STUDY DESIGN


Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480. Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2) Brief intervention: information package as per group 1, plus assessment and brief LBC counselling at a specialised clinic with an obstetric physician and dietitian 6 months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6 month telephone-based LBC program from 6 to 12 months postpartum. All women have an outcome assessment at 12 months.
MAIN OUTCOME MEASURES


Primary outcomes: (a) BP change or (b) weight change and/or waist circumference change.
SECONDARY OUTCOMES


maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios. The study is powered to detect a 4 mmHg difference in systolic BP between groups, or a 4 kg weight loss difference/2cm waist circumference change.
CONCLUSIONS


BP 2  will provide evidence regarding the feasibility and effectiveness of postpartum LBC interventions and structured clinical follow-up in improving cardiovascular health markers after HDP.",2020,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"['women who had HDP in their preceding pregnancy', 'Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480', 'Women who had hypertensive disorders of pregnancy (HDP']","['LBC counselling at a specialised clinic with an obstetric physician and dietitian 6\xa0months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6\xa0month telephone-based LBC program', 'Optimised usual care: information package and family doctor follow-up 6\xa0months postpartum 2']","['Blood pressure postpartum (BP 2 ', 'BP change or (b) weight change and/or waist circumference change', 'maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios', 'systolic BP', 'lifestyle behaviour change (LBC']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4319609', 'cui_str': '480'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0589124', 'cui_str': 'Follow-up 6 months'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4704805', 'cui_str': 'Weight Trajectory'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",480.0,0.118249,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Henry', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; The George Institute for Global Health, Sydney, Australia. Electronic address: Amanda.Henry@unsw.edu.au.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia; Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Faculty of Medicine, University of New South Wales, Sydney, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Makris', 'Affiliation': 'Faculty of Medicine, University of New South Wales, Sydney, Australia; School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Hennessy', 'Affiliation': 'School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Beech', 'Affiliation': 'Royal Hospital for Women, Randwick, New South Wales, Australia.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Pettit', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Se Homer', 'Affiliation': 'Burnet Institute, Melbourne, Victoria, Australia; Faculty of Health, University of Technology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Craig', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.""}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Hyett', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Chambers', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Oisin', 'Initials': 'O', 'LastName': 'Fitzgerald', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Gow', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mann', 'Affiliation': 'General Practitioner, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Challis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Royal Hospital for Women, Randwick, New South Wales, Australia.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Gale', 'Affiliation': 'New South Wales Ministry of Health, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Ruhotas', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Emilee', 'Initials': 'E', 'LastName': 'Kirwin', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Denney-Wilson', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.07.001']
1030,32638035,"The effects of acute serotonin challenge on executive planning in patients with obsessive-compulsive disorder (OCD), their first-degree relatives, and healthy controls.","RATIONALE


Obsessive-compulsive disorder (OCD) is characterized by executive function impairment and by clinical responsivity to selective serotonin reuptake inhibitors (SSRIs). Executive planning deficits constitute a candidate endophenotype for OCD. It is not known whether this endophenotype is responsive to acute serotonin manipulation.
OBJECTIVE


The study aimed to investigate the effects of acute SSRI administration on executive function in patients with OCD, first-degree relatives of patients with OCD, and healthy controls.
METHODS


A randomized double-blind cross-over study assessed the effects of single-dose escitalopram (20 mg) and placebo on executive planning in 24 patients with OCD, 13 clinically unaffected first-degree relatives of patients with OCD, and 28 healthy controls. Performance on a Tower of London task measuring executive planning was assessed 4 h after oral administration of the pharmacological challenge/placebo and compared across and within groups using a mixed model analysis of variance.
RESULTS


On the outcome measure of interest, i.e., the mean number of choices to obtain the correct solution, there was a marginally significant effect of group (F(2, 59) = 3.1; p = 0.052), with patients (least square (LS) mean 1.43; standard error [SE] 0.06; 95% confidence interval (CI), 1.31-1.55) and their relatives (LS mean 1.46; SE 0.08; 95% CI, 1.30-1.62) performing worse than matched healthy controls (LS mean 1.26; SE 0.05; 95% CI, 1.15-1.37) on placebo. There was a trend towards a significant group × treatment interaction (F(2, 58) = 2.8, p = 0.069), with post hoc tests showing (i) patients (p = 0.009; LS mean difference 0.23; SE 0.08) and relatives (p = 0.03; LS mean difference 0.22; SE 0.10) were more impaired compared to controls and (ii) escitalopram was associated with improved executive planning in patients with OCD (p = 0.013; LS mean difference 0.1; SE 0.04), but not other groups (both p > 0.1; controls: LS mean difference - 0.03; SE 0.04; relatives: LS mean difference 0.02; SE 0.05).
CONCLUSION


Our findings are consistent with a view that there is impaired executive planning in OCD and that this constitutes a behavioural endophenotype. In patients with OCD, but not in relatives, acute SSRI administration ameliorated this deficit. Further investigation is needed to understand common and differential involvement of neurochemical systems in patients with OCD and their relatives.",2020,"Performance on a Tower of London task measuring executive planning was assessed 4 h after oral administration of the pharmacological challenge/placebo and compared across and within groups using a mixed model analysis of variance.
","['patients with obsessive-compulsive disorder (OCD), their first-degree relatives, and healthy controls', 'Obsessive-compulsive disorder (OCD', 'patients with OCD and their relatives', 'patients with OCD, first-degree relatives of patients with OCD, and healthy controls', '24 patients with OCD, 13 clinically unaffected first-degree relatives of patients with OCD, and 28 healthy controls']","['acute serotonin challenge', 'acute SSRI administration', 'single-dose escitalopram (20\xa0mg) and placebo', 'placebo']","['executive planning', 'executive function', 'mean number of choices to obtain the correct solution']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0444502', 'cui_str': 'First degree'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]",24.0,0.0857476,"Performance on a Tower of London task measuring executive planning was assessed 4 h after oral administration of the pharmacological challenge/placebo and compared across and within groups using a mixed model analysis of variance.
","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lochner', 'Affiliation': 'SAMRC Unit on Risk and Resilience in Mental Disorders, Department of Psychiatry, Stellenbosch University, Stellenbosch, South Africa. cl2@sun.ac.za.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Chamberlain', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kidd', 'Affiliation': 'Centre for Statistical Consultation, Department of Statistics and Actuarial Sciences, University of Stellenbosch, Stellenbosch, South Africa.'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Taljaard', 'Affiliation': 'SAMRC Unit on Risk and Resilience in Mental Disorders, Department of Psychiatry, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Naomi A', 'Initials': 'NA', 'LastName': 'Fineberg', 'Affiliation': 'National Treatment Service for OCD, Hertfordshire, UK.'}, {'ForeName': 'Trevor W', 'Initials': 'TW', 'LastName': 'Robbins', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Stein', 'Affiliation': 'SAMRC Unit on Risk & Resilience in Mental Disorders, Department of Psychiatry & Neuroscience Institute, University of Cape Town, Cape Town, South Africa.'}]",Psychopharmacology,['10.1007/s00213-020-05597-7']
1031,32640286,Deconstructing the effects of concentration meditation practice on interference control: The roles of controlled attention and inflammatory activity.,"Prior work has linked meditation practice to improvements in interference control. However, the mechanisms underlying these improvements are relatively unknown. In the context of meditation training, improvements in interference control could result eitherfrom increases in controlled attention to goal-relevant stimuli, or from reductions in automatic capture by goal-irrelevant stimuli. Moreover, few studies have linked training-related changes in attention to physiological processes, such as inflammatory activity, that are thought to influence cognitive function. This study addresses these gaps by examining associations between cognitive performance and cytokines in the context of an intensive meditation retreat. Participants were randomly assigned to complete 3 months of meditation training first, or to serve as waitlist controls. The waitlist-control participants then later completed a separate 3-month training intervention. We assessed participants' interference control with a flanker task and used computational modeling to derive component processes of controlled and automatic attention. We also collected blood samples at the beginning, middle, and end of training to quantify changes in cytokine activity. Participants who completed training evidenced better controlled attention than waitlist controls during the first retreat intervention, and controls showed significant improvements in controlled attention when they completed their own, second retreat. Importantly, inflammatory activity was inversely associated with controlled attention during both interventions. Our results suggest that practice of concentration meditation influences interference control by enhancing controlled attention to goal-relevant task elements, and that inflammatory activity relates to individual differences in controlled attention.",2020,"Participants who completed training evidenced better controlled attention than waitlist controls during the first retreat intervention, and controls showed significant improvements in controlled attention when they completed their own, second retreat.",[],"['concentration meditation practice', 'concentration meditation', 'meditation training', 'meditation training first, or to serve as waiting-list controls']","['inflammatory activity', 'interference control']",[],"[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0134664,"Participants who completed training evidenced better controlled attention than waitlist controls during the first retreat intervention, and controls showed significant improvements in controlled attention when they completed their own, second retreat.","[{'ForeName': 'Grant S', 'Initials': 'GS', 'LastName': 'Shields', 'Affiliation': 'Department of Psychological Science, University of Arkansas, Fayetteville, AR, USA. Electronic address: gshields@uark.edu.'}, {'ForeName': 'Alea C', 'Initials': 'AC', 'LastName': 'Skwara', 'Affiliation': 'Center for Mind and Brain, University of California, Davis, CA, USA; Department of Psychology, University of California, Davis, CA, USA.'}, {'ForeName': 'Brandon G', 'Initials': 'BG', 'LastName': 'King', 'Affiliation': 'Center for Mind and Brain, University of California, Davis, CA, USA.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Zanesco', 'Affiliation': 'Department of Psychology, University of Miami, Coral Gables, FL, USA.'}, {'ForeName': 'Firdaus S', 'Initials': 'FS', 'LastName': 'Dhabhar', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Department of Microbiology & Immunology, and The Sylvester Comprehensive Cancer Center, Miller School of Medicine, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Clifford D', 'Initials': 'CD', 'LastName': 'Saron', 'Affiliation': 'Center for Mind and Brain, University of California, Davis, CA, USA. Electronic address: cdsaron@ucdavis.edu.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.06.034']
1032,32643358,Efficacy of dexmedetomidine as an adjuvant to Quadratus lumborum block for pediatrics undergoing laparoscopic pyeloplasty. A prospective randomized double blinded study.,"BACKGROUND


We designed this study to evaluate dexmedetomidine as an adjuvant to local anesthetics in Quadratus lumborum block (QLB) in pediatrics either interfascial versus intravenous on the quality of postoperative analgesia and incidence of side effects.
METHODS


Fifty pediatric patients ASA I and II, from eight to thirteen years old posted for laparoscopic pyeloplasty were randomized either to: QLB dexmedetomidine intravenous (QD IV) group or QLB dexmedetomidine interfascial (QD IF) group. A 24-h postoperative morphine consumption (primary outcome), time to first analgesic request, postoperative pain and sedation scores were compared. The recovery time after anesthesia and the incidences of intraoperative and postoperative hypotension or bradycardia were recorded.
RESULTS


The median [IQR] 24 h postoperative morphine consumption in QD IF group [0.05 (0.05-0.10) mg/kg] was lower compared with QD IV group [0.15 (0.10-0.20) mg/kg] (P<0.001). Longer time to first analgesic request was noted in QD IF group [505 (395-583) min] in comparison to QD IV group [306 (258-388) min] (P<0.001). Pain scores were lower in QD IF group at six and eight hours postoperatively. Sedation scores were lower in QD IF group on admission to PACU and two hours postoperatively. Intraoperative hypotension and bradycardia were lower in QD IF group. Longer recovery time in QD IV group.
CONCLUSIONS


Interfascial dexmedetomidine adjuvant to QLB provided better postoperative analgesia in terms of less morphine consumption, better pain scores and longer time to first analgesic request when compared with the IV dexmedetomidine.",2020,Longer time to first analgesic request was noted in QD IF group [505 (395 - 583) min] in comparison to QD IV group [306 (258 - 388) min] (P ˂ 0.001).,"['paediatrics undergoing laparoscopic pyeloplasty', 'Fifty paediatric patients ASA I and II, from eight to thirteen years old posted for']","['QLB', 'QLB dexmedetomidine intravenous (QD IV', 'dexmedetomidine interfascial (QD IF', 'laparoscopic pyeloplasty', 'dexmedetomidine']","['Intraoperative hypotension and bradycardia', 'pain scores', 'Longer recovery time', 'median [IQR] 24 h postoperative morphine consumption', 'time to first analgesic request, postoperative pain and sedation scores', 'Sedation scores', 'recovery time after anaesthesia and the incidences of intraoperative and postoperative hypotension or bradycardia', 'postoperative analgesia', 'Longer time to first analgesic request', 'Pain scores']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0812509', 'cui_str': 'Laparoscopic pyeloplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0812509', 'cui_str': 'Laparoscopic pyeloplasty'}]","[{'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0865752', 'cui_str': 'Postoperative hypotension'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",50.0,0.133798,Longer time to first analgesic request was noted in QD IF group [505 (395 - 583) min] in comparison to QD IV group [306 (258 - 388) min] (P ˂ 0.001).,"[{'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Abdellatif', 'Affiliation': 'Department of Anesthesiology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Amr A', 'Initials': 'AA', 'LastName': 'Kasem', 'Affiliation': 'Department of Anesthesiology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Bestarous', 'Affiliation': 'Department of Anesthesiology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Tamer N', 'Initials': 'TN', 'LastName': 'Toaima', 'Affiliation': 'Department of Anesthesiology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Ali', 'Affiliation': 'Department of Anesthesiology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Shokri', 'Affiliation': 'Department of Anesthesiology, Ain Shams University, Cairo, Egypt - Drhoda10@yahoo.com.'}]",Minerva anestesiologica,['10.23736/S0375-9393.20.14298-6']
1033,32648429,Editorial Comment: Cardiovascular Morbi-dity in a Randomized Trial Comparing GnRH Agonist and GnRH Antagonist among Pati-ents with Advanced Prostate Cancer and Preexisting Cardiovascular Disease.,,2020,,['Pati-ents with Advanced Prostate Cancer and Preexisting Cardiovascular Disease'],['GnRH Agonist and GnRH Antagonist'],[],"[{'cui': 'C0150934', 'cui_str': 'Ear, nose and throat structure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}]",[],,0.0524597,,"[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lott', 'Affiliation': 'Instituto Nacional do Câncer - INCA, Rio de Janeiro, RJ, Brasil.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2020.05.09']
1034,32648430,Editorial Comment: Randomised Trial of Adjuvant Radiotherapy Following Radical Pros-tatectomy Versus Radical Prostatectomy Alone in Prostate Cancer Patients with Posi-tive Margins or Extracapsular Extension.,,2020,,['Prostate Cancer Patients with Posi-tive Margins or Extracapsular Extension'],"['Adjuvant Radiotherapy Following Radical Pros', 'tatectomy Versus Radical Prostatectomy Alone']",[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C3899187', 'cui_str': 'Extracapsular Extension'}]","[{'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]",[],,0.0471933,,"[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lott', 'Affiliation': 'Instituto Nacional do Câncer - INCA, Rio de Janeiro, RJ, Brasil.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2020.05.10']
1035,32645143,Smell-Based Memory Training: Evidence of Olfactory Learning and Transfer to the Visual Domain.,"Human and non-human animal research converge to suggest that the sense of smell, olfaction, has a high level of plasticity and is intimately associated with visual-spatial orientation and memory encoding networks. We investigated whether olfactory memory (OM) training would lead to transfer to an untrained visual memory (VM) task, as well as untrained olfactory tasks. We devised a memory intervention to compare transfer effects generated by olfactory and non-olfactory (visual) memory training. Adult participants were randomly assigned to daily memory training for about 40 days with either olfactory or visual tasks that had a similar difficulty level. Results showed that while visual training did not produce transfer to the OM task, olfactory training produced transfer to the untrained VM task. Olfactory training also improved participants' performance on odor discrimination and naming tasks, such that they reached the same performance level as a high-performing group of wine professionals. Our results indicate that the olfactory system is highly responsive to training, and we speculate that the sense of smell may facilitate transfer of learning to other sensory domains. Further research is however needed in order to replicate and extend our findings.",2020,"Results showed that while visual training did not produce transfer to the olfactory memory task, olfactory training produced transfer to the untrained visual memory task.",['Adult participants'],"['olfactory memory training', 'olfactory and non-olfactory (visual) memory training', 'Smell-based memory training', 'Olfactory training', 'daily memory training']","['olfactory memory task, olfactory training produced transfer to the untrained visual memory task', ""participants' performance on odor discrimination and naming tasks""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0729377', 'cui_str': 'Memory skills training'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}]",,0.0220731,"Results showed that while visual training did not produce transfer to the olfactory memory task, olfactory training produced transfer to the untrained visual memory task.","[{'ForeName': 'Jonas K', 'Initials': 'JK', 'LastName': 'Olofsson', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Ekström', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Lindström', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Elmeri', 'Initials': 'E', 'LastName': 'Syrjänen', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Stigsdotter-Neely', 'Affiliation': 'Department of Social and Psychological Studies, Karlstad University, Karlstad, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nyberg', 'Affiliation': 'Umeå Center for Functional Brain Imaging, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Jonsson', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Larsson', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}]",Chemical senses,['10.1093/chemse/bjaa049']
1036,32650261,Efficacy and safety of systemic tranexamic acid administration in total knee arthroplasty: A case series.,"INTRODUCTION


Total knee arthroplasty (TKA) are associated with significant postoperative blood loss. Tranexamic acid (TXA) is a potent agent with antifibrinolytic activity, that can be administered via the intravenous (IV) and/or topical (intra-articular, IA) route, which can possibly interrupt the cascade of events due to hemostatic irregularities close to the source of bleeding. However, the literature contains scarce scientific evidence related to IV only TXA usage in TKA. The current study aims to compare the outcome between patients who were administered IV TXA and a control group in terms of blood loss, transfusion rate, and incidence of deep vein thrombosis (DVT) and thromboembolism (TE).
METHODS


110 patients, who underwent TKA were placed into two groups: 1) 34 patients who received IV TXA; and 2) 76 patients in the control group. In the TXA group, patients received an IV TXA dose of 1 g, 30 min before incision. Two drains were placed.
RESULTS


Usage of IV TXA showed better results when compared to the control group in terms of mean blood transfusion (0.5 less transfusion during hospital stay), hemoglobin drop (10%). No cases of DVT or TE were noted among the two study groups.
CONCLUSION


Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA. Moreover, TXA use is safe in terms of incidence of symptomatic DVT and TE.",2020,Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA.,"['total knee arthroplasty', '110 patients, who underwent TKA were placed into two groups: 1) 34 patients who received']","['IV TXA', 'TXA', 'systemic tranexamic acid', 'Tranexamic acid (TXA', 'Total knee arthroplasty (TKA']","['mean blood transfusion', 'DVT or TE', 'Efficacy and safety', 'blood loss, transfusion rate, and incidence of deep vein thrombosis (DVT) and thromboembolism (TE']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",110.0,0.0314014,Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA.,"[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Maalouly', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Josephmaalouly2@gmail.com.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'El Assaad', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Donna.elassaad@lau.edu.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Ayoubi', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: rami.ayoubi1@gmail.com.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Tawk', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Antoniostawk@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Darwish', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Mohammaddarwish2@gmail.com.'}, {'ForeName': 'Dany', 'Initials': 'D', 'LastName': 'Aouad', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Dany_aouad@hotmail.com.'}, {'ForeName': 'Georgio', 'Initials': 'G', 'LastName': 'Lati', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Georgio.lati@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Darwish', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Mohammaddarwish2@gmail.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'El Rassi', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: gselrassi@gmail.com.'}]",International journal of surgery case reports,['10.1016/j.ijscr.2020.06.077']
1037,32658147,A digital health psychological intervention (WebMAP Mobile) for children and adolescents with chronic pain: results of a hybrid effectiveness-implementation stepped-wedge cluster randomized trial.,"Although psychological treatments benefit youth with chronic pain, treatment is not accessible in most communities. Digital health interventions offer promise for expanding access and reach to this population. Using a stepped-wedge cluster randomized trial design, we evaluated effectiveness and implementation of a digital health delivered psychological intervention for pediatric chronic pain. One hundred forty-three youth, aged 10 to 17 years, with chronic pain and a caregiver were recruited from 8 clinics in the United States. Active intervention included access to the Web-based Management of Adolescent Pain (WebMAP) Mobile app and the WebMAP parent web site to learn pain self-management skills. Effectiveness outcomes included pain intensity, disability, and patient global impression of change, while Reach, Adoption, Implementation, and Maintenance were implementation outcomes. Results showed that youth in both treatment conditions (WebMAP vs Usual Care) had similar changes over time in pain and disability. Youth in the WebMAP condition perceived greater improvement (patient global impression of change) at post-treatment and follow-up (d's = 0.54 and 0.44, P < 0.05) compared with youth receiving usual care. Use of the digital health intervention was modest and variable; approximately 30% of youth and parents completed treatment. Greater engagement (number of completed modules) was associated with significantly greater reductions in pain and disability from pre-treatment to follow-up (d's = -0.57 and -0.38, P < 0.05). Parents, youth, and providers found treatment acceptable; providers had positive attitudes and demonstrated referrals over a maintenance period. Further research is needed to understand how to enhance treatment engagement with digital health interventions and optimize implementation.",2020,Youth in the WebMAP condition perceived greater improvement (PGIC) at post-treatment and follow-up,"['143 youth, ages 10-17 with chronic pain and a caregiver were recruited from 8 clinics in the United States', 'children and adolescents with chronic pain', 'pediatric chronic pain']","['digital health intervention', 'digital health delivered psychological intervention', 'Digital health interventions', 'digital health psychological intervention (WebMAP Mobile']","['pain intensity, disability, and patient global impression of change (PGIC), while Reach, Adoption, Implementation, and Maintenance were implementation outcomes', 'improvement (PGIC', 'pain and disability']","[{'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.138307,Youth in the WebMAP condition perceived greater improvement (PGIC) at post-treatment and follow-up,"[{'ForeName': 'Tonya M', 'Initials': 'TM', 'LastName': 'Palermo', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, United States.""}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'de la Vega', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, United States.""}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Murray', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, United States.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Law', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, United States.""}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, United States.""}]",Pain,['10.1097/j.pain.0000000000001994']
1038,32653577,Evaluation of platelet-rich plasma as a treatment for androgenetic alopecia: A randomized controlled trial.,"BACKGROUND


Platelet-rich plasma (PRP) shows promise as an androgenetic alopecia (AGA) treatment.
OBJECTIVE


To conduct a randomized placebo-controlled split-scalp study to investigate the effects of PRP on hair regrowth and thickness.
METHODS


Two 7.6-cm × 7.6-cm squares were tattooed on the scalps of 35 study participants with AGA. Areas were randomly assigned to intradermal injection with PRP or saline. Participants received 3 monthly treatment sessions with evaluation 3 months after the final treatment.
RESULTS


Hair density in the PRP-treated area was significantly increased compared with baseline at all visits. At the final assessment, hair density in PRP-treated areas increased from 151 ± 39.82 hairs/cm 2  at baseline to 170.96 ± 37.14 hairs/cm 2 , a mean increase of approximately 20 hairs/cm 2  (P < .05). However, hair density in placebo-treated areas also increased from 151.04 ± 41.99 hairs/cm 2  to 166.72 ± 37.13 hairs/cm 2  (P < .05). There was no significant difference in hair density change between the 2 groups (P > .05). No serious adverse events were reported.
LIMITATIONS


Possible PRP diffusion due to split-scalp study design as well as microinjections causing microinjury to both sides.
CONCLUSION


PRP may have benefit in increasing hair density.",2020,"At the final assessment, hair density in PRP-treated areas increased from 151 ± 39.82 hairs/cm 2  at baseline to 170.96 ± 37.14 hairs/cm 2 , a mean increase of approximately 20 hairs/cm 2  (p < 0.05).","['35 study participants with AGA had two 7.6-centimeter x 7.6-centimeter squares tattooed on their scalps', 'androgenetic alopecia']","['intradermal injection with PRP or saline', 'platelet-rich plasma', 'placebo']","['hair regrowth and thickness', 'hair density in PRP-treated areas', 'serious adverse events', 'Hair density', 'hair density', 'hair density change']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0475210', 'cui_str': 'cm'}, {'cui': 'C0439479', 'cui_str': 'sq. cm'}, {'cui': 'C0039343', 'cui_str': 'Tattooing'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}]","[{'cui': 'C0021489', 'cui_str': 'Intradermal injection'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",35.0,0.0990235,"At the final assessment, hair density in PRP-treated areas increased from 151 ± 39.82 hairs/cm 2  at baseline to 170.96 ± 37.14 hairs/cm 2 , a mean increase of approximately 20 hairs/cm 2  (p < 0.05).","[{'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Shapiro', 'Affiliation': 'Ronald O. Perelman Department of Dermatology, New York University Grossman School of Medicine, New York, New York. Electronic address: Jerry.Shapiro@nyulangone.org.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ho', 'Affiliation': 'Ronald O. Perelman Department of Dermatology, New York University Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Sukhdeo', 'Affiliation': 'Pilaris Dermatology, New York, New York.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Ronald O. Perelman Department of Dermatology, New York University Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Lo Sicco', 'Affiliation': 'Ronald O. Perelman Department of Dermatology, New York University Grossman School of Medicine, New York, New York.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.07.006']
1039,32659755,Prophylactic Ligature of AV Fistula Prevents High Output Heart Failure after Kidney Transplantation.,"BACKGROUND


Arteriovenous (AV) fistulas are considered the gold standard for ensuring safe and long-term vascular access in patients with haemodialysis-dependent end-stage renal disease. However, previous studies demonstrated that high-flow AV fistulas might add additional cardiovascular burden in the post-transplant setting, leading to frequent fistula closure in this population. Currently, there is no consensus regarding management of high-flow fistulas in post-transplant patients with stable kidney function. The present randomized controlled trial examines the effect of prophylactic AV fistula closure on high-output heart failure.
METHODS


Twenty-eight kidney transplant patients with stable graft function, absence of pre-existing severe cardiac failure, and brachial arterial flow rate of at least 1,500 mL/min were recruited and randomized in a 1:1 ratio to an intervention and control group, respectively. The intervention group was subject to immediate fistula ligature. Patients within the control group were referred to fistula ligature only if the main study endpoint high-output heart failure was reached. The latter was defined by the presence of at least 1 clinical sign (i.e., worsening NYHA score) and at least 2 of the following echocardiographic parameters: diameter of right atrium (major) >53 mm, right atrium (minor) >44 mm, inferior vena cava ≥21 mm, right pulmonary artery >20 mm, TAPSE <16 mm, systolic pulmonal artery pressure >40 mm Hg, and/or left ventricular eccentricity index <1. During a 24-month follow-up period, quarterly measurements of kidney function, NT-proBNP, and lactate dehydrogenase as well as a biannual echocardiographic check-up were performed.
RESULTS


High-output heart failure attributable to high-flow fistula was reported in 5 of 13 control patients (38.5%), whereas no patient in the intervention group presented with clinical and echocardiographic signs of high-output heart failure during the follow-up period. Thus, prophylactic ligature of high-flow fistulas avoided high-output heart failure in our patient population (p = 0.013). Three patients in the control group, however, had to undergo fistula ligature due to aneurysm formation (n = 2) and steal phenomenon (n = 1). Median NT-proBNP levels decreased from 317 ng/L pre-ligature to 223 ng/L post-ligature (p = 0.003). Serum creatinine levels did not significantly differ before and after AV fistula ligature (1.69 vs. 1.60 mg/dL, respectively, p = 0.059). Improvement of echocardiographic findings (e.g., a decrease in systolic pulmonary arterial pressure) was found in 7 of 8 ligature patients but did not reach statistical significance.
CONCLUSION


Prophylactic ligature of high-flow AV fistulas after kidney transplantation can avoid high-output heart failure, and a more liberal approach to close AV fistulas might be justified.",2020,"Serum creatinine levels did not significantly differ before and after AV fistula ligature (1.69 vs. 1.60 mg/dL, respectively, p = 0.059).","['patients with haemodialysis-dependent end-stage renal disease', 'Twenty-eight kidney transplant patients with stable graft function, absence of pre-existing severe cardiac failure, and brachial arterial flow rate of at least 1,500 mL/min', 'Kidney Transplantation', 'post-transplant patients with stable kidney function']","['prophylactic AV fistula closure', 'Prophylactic Ligature of AV Fistula']","['clinical and echocardiographic signs of high-output heart failure', 'Serum creatinine levels', 'systolic pulmonary arterial pressure', 'systolic pulmonal artery pressure', 'Median NT-proBNP levels', 'kidney function, NT-proBNP, and lactate dehydrogenase']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0429856', 'cui_str': 'Arterial flow'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0023692', 'cui_str': 'Ligature'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0221045', 'cui_str': 'High output heart failure'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1168098', 'cui_str': 'Pulmonary arterial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}]",28.0,0.0372347,"Serum creatinine levels did not significantly differ before and after AV fistula ligature (1.69 vs. 1.60 mg/dL, respectively, p = 0.059).","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Hetz', 'Affiliation': 'Department of Internal Medicine IV - Nephrology and Hypertension, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Pirklbauer', 'Affiliation': 'Department of Internal Medicine IV - Nephrology and Hypertension, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Müller', 'Affiliation': 'Department of Internal Medicine III - Cardiology and Angiology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Posch', 'Affiliation': 'Department for Surgery, University Hospital for Vascular Surgery, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gummerer', 'Affiliation': 'Department for Surgery, University Hospital for Vascular Surgery, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tiefenthaler', 'Affiliation': 'Department of Internal Medicine IV - Nephrology and Hypertension, Medical University Innsbruck, Innsbruck, Austria, martin.tiefenthaler@i-med.ac.at.'}]",American journal of nephrology,['10.1159/000508957']
1040,32662280,Integrating the Early Start Denver Model into Israeli community autism spectrum disorder preschools: Effectiveness and treatment response predictors.,"LAY ABSTRACT


Early intensive intervention has been shown to significantly affect the development of children with Autism. However, the costly implementation of such interventions limits their wide dissemination in the community. This study examined an integration of a research-supported early intensive intervention model called the Early Start Denver Model into community preschool programs for children with Autism in Israel. Four community preschools implemented the preschool-based Early Start Denver Model and four implemented the existing multidisciplinary developmental intervention which is widely applied in Israeli community preschools for children with autism. Fifty-one children (aged 33-57 months) participated in the study. Twenty-six attended the preschool-based Early Start Denver Model preschools and twenty-five attended the multidisciplinary developmental intervention preschools. Before the intervention began, groups were comparable on children's age and developmental functioning and on families' socio-economic status. Results showed that, compared to the multidisciplinary developmental intervention group, children in the preschool-based Early Start Denver Model treatment group made greater gains on measures of overall cognitive development, language skills, as well as on parent- and teacher-reported adaptive communication and socialization abilities. Children who had lower autism symptom severity, higher adaptive functioning and better language understanding abilities before taking part in the preschool-based Early Start Denver Model program showed greater improvements following it. This study documents the successful implementation of an intensive early intervention program in pre-existing community preschools, underlining the importance of the integration of research-supported intervention programs into community settings.",2020,"Before the intervention began, groups were comparable on children's age and developmental functioning and on families' socio-economic status.","['children with Autism in Israel', 'children with autism', 'children with Autism', 'Fifty-one children (aged 33-57\u2009months) participated in the study', 'Twenty-six attended the preschool-based Early Start Denver Model preschools and twenty-five attended the multidisciplinary developmental intervention preschools']",['intensive early intervention program'],"['overall cognitive development, language skills, as well as on parent- and teacher-reported adaptive communication and socialization abilities', 'adaptive functioning and better language understanding abilities']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0037447', 'cui_str': 'Socialization'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",51.0,0.0150567,"Before the intervention began, groups were comparable on children's age and developmental functioning and on families' socio-economic status.","[{'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Sinai-Gavrilov', 'Affiliation': 'Bar-Ilan University, Israel.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Gev', 'Affiliation': 'Bar-Ilan University, Israel.'}, {'ForeName': 'Irit', 'Initials': 'I', 'LastName': 'Mor-Snir', 'Affiliation': 'The Association for Children at Risk, Israel.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Vivanti', 'Affiliation': 'Drexel University, USA.'}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Golan', 'Affiliation': 'Bar-Ilan University, Israel.'}]",Autism : the international journal of research and practice,['10.1177/1362361320934221']
1041,32665197,Sutureless versus interrupted sutures techniques for neonatal circumcision; a randomized clinical trial.,"INTRODUCTION


and objective: Male circumcision is a common procedure all over the world; in Saudi Arabia, circumcision is the most frequent elective surgical procedure performed on males. The use of sutures for neonatal circumcision may decrease bleeding; however, it may lead to skin sinus formation. The objective of this study was to compare the sutureless to the interrupted sutures technique for neonatal circumcision with Gamco clamp.
PATIENTS AND METHODS


We performed a randomized controlled clinical trial between 2017 and 2018. The study included 182 newborns assigned into two groups. Group 1 (n = 94) included neonates who had sutureless circumcision, and group 2 (n = 89) included neonates who underwent circumcision using interrupted absorbable 6/0 sutures. Study endpoints were bleeding, wound gaping, skin tunneling or sinus, and cyst formation.
RESULTS


There was no significant difference in patients' age and weight between groups. The procedure was significantly longer in group 2 (12.24 ± 2.17 vs. 6.54 ± 1.42 min; p < 0.001). There was no difference in bleeding between both groups (4 (4.26%) vs. 2 (2.27%) in groups 1 and 2, respectively, p = 0.683). Cyst formation was significantly reduced in group 1 (2 (2.13%) vs. 13 (14.77%); p = 0.002) and skin sinus formation increased in group 2 (14 (15.91%) vs. 0 in group 2 and 1, respectively; p < 0.001).
DISCUSSION


Circumcision can be performed with several techniques, and the superiority of one approach over the other is still debated. Many surgeons use interrupted sutures to oppose the skin edges, and in some reports, tissue glue was used for skin edges re-approximation with acceptable cosmetic results. In our study, the mean time taken for sutureless circumcision was about 7 min, and for the suture circumcision, it took around 11 min. In addition, the formation of a skin tunnel or sinuses rate was high despite the use of very thin sutures.
CONCLUSION


Male circumcision is a common and safe technique with minor and treatable complications. Risks of bleeding and sinus track formation are low with the sutureless method. The sutureless technique is recommended after Gamco circumcision as the standard technique for male circumcision in the newborn.",2020,"Cyst formation was significantly reduced in group 1 (2 (2.13%) vs. 13 (14.77%); p = 0.002) and skin sinus formation increased in group 2 (14 (15.91%) vs. 0 in group 2 and 1, respectively; p < 0.001).
","['182 newborns assigned into two groups', '2017 and 2018', 'Group 1 (n\xa0=\xa094) included neonates who had sutureless circumcision, and group 2 (n\xa0=\xa089) included neonates who underwent']","['Sutureless versus interrupted sutures techniques', 'circumcision using interrupted absorbable 6/0 sutures']","['formation of a skin tunnel or sinuses rate', 'Risks of bleeding and sinus track formation', 'mean time taken for sutureless circumcision', 'bleeding, wound gaping, skin tunneling or sinus, and cyst formation', 'skin sinus formation', 'bleeding', 'Cyst formation']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0038968', 'cui_str': 'Suturing techniques'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0423772', 'cui_str': 'External fistula'}]",182.0,0.0270562,"Cyst formation was significantly reduced in group 1 (2 (2.13%) vs. 13 (14.77%); p = 0.002) and skin sinus formation increased in group 2 (14 (15.91%) vs. 0 in group 2 and 1, respectively; p < 0.001).
","[{'ForeName': 'Osama A', 'Initials': 'OA', 'LastName': 'Bawazir', 'Affiliation': 'Department of Surgery, Faculty of medicine Umm Al-Qura University, Makkah& King Faisal Specialist Hospital & Research Centre, Saudi Arabia. Electronic address: obawazir@yahoo.com.'}, {'ForeName': 'Abdulaziz M', 'Initials': 'AM', 'LastName': 'Banaja', 'Affiliation': 'Department of Surgery, Faculty of medicine Umm Al-Qura University, Makkah& King Faisal Specialist Hospital & Research Centre, Saudi Arabia. Electronic address: Azizbanaja@hotmail.com.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.06.025']
1042,32586100,Prognostic evaluation of serum long non-coding RNA H19 for endoscopic keyhole surgery or craniotomy in glioma.,"BACKGROUND


Our study aims to explore the effect of serum long non-coding RNA (lncRNA) H19 level on the long-term prognosis of endoscopic keyhole surgery or craniotomy for glioma.
METHODS


A total of 264 glioma patients were selected. Patients were randomly divided into the Craniotomy-high H19 group, the Craniotomy-low H19 group, the Endoscopic keyhole surgery-high H19 group and the Endoscopic keyhole surgery-low H19 group.
RESULTS


Compared with adjacent tissues (5.19 ± 1.42), H19 level in cancer tissues (7.45 ± 1.60) and serum (6.44 ± 1.57) was significantly increased ( P  <   0.05). Compared with serum, H19 level in cancer tissues was significantly increased ( P  <   0.05). Pearson correlation analysis found that the relative expression level of serum H19 in glioma patients was positively correlated with cancer tissues ( r Pearson  = 0.547,  P  <   0.001), but had no significant correlation with adjacent tissues ( r Pearson  = 0.126,  P   =    0.207). The expression of H19 in serum was significantly related to WHO grade ( r Pearson  = 0.514,  P  <   0.001). Compared with the Endoscopic keyhole surgery-high H19 group and the Endoscopic keyhole surgery-low H19 group, the survival rate of patients in the Craniotomy-high H19 group (χ 2  = 17.115 and log-rank  P  <   0.001; χ 2  = 18.406 and log-rank  P  <   0.001) and the Craniotomy-low H19 group was significantly reduced (χ 2  = 15.007 and log-rank  P  <   0.001; χ 2  = 16.121 and log-rank  P  <   0.001). Cox regression results showed that serum H19 level, craniotomy and WHO grade were risk factors for glioma. When H19 level was lower than 6.28, the 30-month survival rate of patients with the endoscopic keyhole surgery was 100%.
CONCLUSION


For patients with low H19 level (<5.36), both endoscopic keyhole surgery and craniotomy are available, otherwise, endoscopic keyhole surgery is more recommended.",2020,<   0.001) and the Craniotomy-low H19 group was significantly reduced (χ 2  = 15.007 and log-rank  P  ,"['endoscopic keyhole surgery or craniotomy in glioma', '264 glioma patients were selected']","['Craniotomy-high H19 group, the Craniotomy-low H19 group, the Endoscopic keyhole surgery-high H19 group and the Endoscopic keyhole surgery-low H19 group', 'serum long non-coding RNA (lncRNA', 'endoscopic keyhole surgery or craniotomy']","['survival rate', 'serum H19 level, craniotomy and WHO grade were risk factors for glioma', 'H19 level in cancer tissues', 'expression of H19 in serum', '30-month survival rate']","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",264.0,0.043746,<   0.001) and the Craniotomy-low H19 group was significantly reduced (χ 2  = 15.007 and log-rank  P  ,"[{'ForeName': 'Likui', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Neurosurgery & Brain and Nerve Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Neurosurgery, Kunshan Hospital of Traditional Chinese Medicine, Kunshan Affiliated Hospital of Nanjing University of Chinese Medicine, Suzhou, China.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Suzhou Kowloon Hospital, Shanghai Jiaotong University School of Medicine, Suzhou, China.'}, {'ForeName': 'Zhengquan', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Neurosurgery & Brain and Nerve Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou, China.'}]",Annals of clinical biochemistry,['10.1177/0004563220941888']
1043,32679045,Predictors of severe pain during insertion of the levonorgestrel 52 mg intrauterine system among nulligravid women.,"OBJECTIVE


To identify sociodemographic and clinical variables associated with severe pain with levonorgestrel 52 mg intrauterine system (IUS) placement among nulligravid women.
STUDY DESIGN


We performed a secondary analysis of a randomized trial that evaluated intracervical anesthesia before IUS insertion. We assessed factors associated with severe pain (visual analog scale pain score ≥7) immediately after insertion using bivariate and multiple regression analyses.
RESULTS


Overall, 137/300 (45.7%) subjects reported severe pain. In multiple regression analysis, only intracervical anesthesia [RR 0.55, 95% CI 0.37-0.80] and a history of dysmenorrhea [RR 1.36, 95% CI 1.08-1.72)] were associated with severe pain.
CONCLUSIONS


Among nulligravid women, a history of dysmenorrhea increases, and intracervical block decreases severe pain during levonorgestrel IUS insertion.
IMPLICATIONS


Dysmenorrhea increases the risk of severe pain at levonorgestrel intrauterine system insertion, while receiving an intracervical lidocaine block decreases this risk. This information can be useful for counseling women prior to device placement and for selecting candidates who may particularly benefit from interventions to reduce pain.",2020,"In multiple regression analysis, only intracervical anesthesia [RR 0.55, 95% CI 0.37-0.80] and a history of dysmenorrhea [RR 1.36, 95%CI 1.08-1.72)] were associated with severe pain.
",['nulligravid women'],"['lidocaine block', 'levonorgestrel 52mg intrauterine system (IUS) placement', 'levonorgestrel']","['severe pain', 'history of dysmenorrhea', 'severe pain (visual analog scale pain score']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0937459', 'cui_str': 'Levonorgestrel 833 nanogram/hour prolonged-release intrauterine drug delivery system'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}]","[{'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0475168', 'cui_str': 'H/O: dysmenorrhea'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",,0.301743,"In multiple regression analysis, only intracervical anesthesia [RR 0.55, 95% CI 0.37-0.80] and a history of dysmenorrhea [RR 1.36, 95%CI 1.08-1.72)] were associated with severe pain.
","[{'ForeName': 'Letícia Sanchez', 'Initials': 'LS', 'LastName': 'Ferreira', 'Affiliation': 'Department of Obstetrics and Gynecology, Ribeirao Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900 - Campus Universitário - Monte Alegre, CEP: 14049-900 Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Mariane Nunes', 'Initials': 'MN', 'LastName': 'de Nadai', 'Affiliation': 'Department of Obstetrics and Gynecology, Ribeirao Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900 - Campus Universitário - Monte Alegre, CEP: 14049-900 Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Omero B', 'Initials': 'OB', 'LastName': 'Poli-Neto', 'Affiliation': 'Department of Obstetrics and Gynecology, Ribeirao Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900 - Campus Universitário - Monte Alegre, CEP: 14049-900 Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Silvio A', 'Initials': 'SA', 'LastName': 'Franceschini', 'Affiliation': 'Department of Obstetrics and Gynecology, Ribeirao Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900 - Campus Universitário - Monte Alegre, CEP: 14049-900 Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Cássia R T', 'Initials': 'CRT', 'LastName': 'Juliato', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medical Science, University of Campinas, Caixa Postal 6181, CEP 13084-971 Campinas, SP, Brazil.'}, {'ForeName': 'Ilza Maria U', 'Initials': 'IMU', 'LastName': 'Monteiro', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medical Science, University of Campinas, Caixa Postal 6181, CEP 13084-971 Campinas, SP, Brazil.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Bahamondes', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medical Science, University of Campinas, Caixa Postal 6181, CEP 13084-971 Campinas, SP, Brazil.'}, {'ForeName': 'Carolina Sales', 'Initials': 'CS', 'LastName': 'Vieira', 'Affiliation': 'Department of Obstetrics and Gynecology, Ribeirao Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900 - Campus Universitário - Monte Alegre, CEP: 14049-900 Ribeirão Preto, SP, Brazil. Electronic address: carol.sales@uol.com.br.'}]",Contraception,['10.1016/j.contraception.2020.07.004']
1044,32681460,Reduced Hypoglycemia Risk in Type 2 Diabetes Patients Switched to/Initiating Insulin Glargine 300 vs 100 U/ml: A European Real-World Study.,"INTRODUCTION


Randomized controlled trials and real-world data from the USA have shown similar glycemic control with insulin glargine 300 U/ml (Gla-300) and insulin glargine 100 U/ml (Gla-100) and reduced hypoglycemia risk with Gla-300. This real-world study describes the efficacy and safety of Gla-300 and Gla-100 in patients with type 2 diabetes (T2D) in France, Spain, and Germany.
METHODS


This retrospective chart review analysis used anonymized data for adults with T2D switching basal insulin analog (BIA) therapy to Gla-300 or Gla-100, or insulin-naïve patients initiating Gla-300 or Gla-100. Outcomes included change from baseline to 6-month follow-up in glycated hemoglobin A1c (A1C), total and severe hypoglycemia incidences and events, insulin dose, and reasons for BIA choice.
RESULTS


Six hundred sixty-five physicians (33.8% Spain, 31.7% France, 34.4% Germany) provided chart data for patients switching to Gla-300 (n = 679) or Gla-100 (n = 429) or initiating Gla-300 (n = 719) or Gla-100 (n = 711). After adjustment for baseline characteristics, A1C reductions from baseline were similar for patients switching to Gla-300 or Gla-100 (- 0.87% vs. - 0.93%; p = 0.326) while those switched to Gla-300 vs. Gla-100 had a significantly greater mean reduction in hypoglycemic events (- 1.29 vs. - 0.81 events during 6 months; p = 0.012). Mean insulin doses after titration were 0.43 ± 0.36 and 0.40 ± 0.28 U/kg in Gla-300 and Gla-100 switchers, respectively. Factors that significantly influenced BIA choice included a lower risk of hypoglycemia (for Gla-300) and physician familiarity (for Gla-100). Outcomes for insulin-naïve patients were broadly similar to those of switchers.
CONCLUSIONS


In this real-world European study, patients with T2D who switched therapy to Gla-300 or Gla-100 had improved glycemic control and reduced hypoglycemia at 6 months, with significant hypoglycemia advantages with Gla-300.",2020,"Outcomes for insulin-naïve patients were broadly similar to those of switchers.
","['Six hundred sixty-five physicians', '300 vs 100 U', 'adults with T2D switching basal insulin analog (BIA) therapy to Gla-300 or Gla-100, or insulin-naïve patients initiating Gla-300 or Gla-100', 'patients with type 2 diabetes (T2D) in France, Spain, and Germany']","['Gla-300 and Gla-100', 'Insulin Glargine']","['glycated hemoglobin A1c (A1C), total and severe hypoglycemia incidences and events, insulin dose, and reasons for BIA choice', 'risk of hypoglycemia (for Gla-300) and physician familiarity (for Gla-100', 'Hypoglycemia Risk', 'Mean insulin doses', 'glycemic control and reduced hypoglycemia', 'hypoglycemic events', 'hypoglycemia risk']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}]",,0.0204853,"Outcomes for insulin-naïve patients were broadly similar to those of switchers.
","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escalada', 'Affiliation': 'Clinic University of Navarra, Pamplona, Spain. fjavier.escalada@gmail.com.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Bonnet', 'Affiliation': 'CHU de Rennes, Université Rennes 1, Rennes, France.'}, {'ForeName': 'Jasmanda', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Bonnemaire', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Shaloo', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Kantar, New York, NY, USA.'}, {'ForeName': 'Janelle M', 'Initials': 'JM', 'LastName': 'Cambron-Mellott', 'Affiliation': 'Kantar, New York, NY, USA.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Nicholls', 'Affiliation': 'Sanofi, Reading, UK.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Müller-Wieland', 'Affiliation': 'Department of Medicine, University Hospital Aachen, Aachen, Germany.'}]",Advances in therapy,['10.1007/s12325-020-01436-5']
1045,33065729,Exposure to Short Wavelength-enriched White Light and Exercise Improves Alertness and Performance in Operational NASA Flight Controllers Working Overnight Shifts.,"OBJECTIVE


We evaluated the efficacy of a combined short-wavelength-enriched white light and exercise fatigue countermeasure during breaks for flight controllers working overnight shifts.
METHODS


Twenty NASA flight controllers were studied for two blocks of nightshifts in ISS mission control, randomized to either the control or countermeasure condition. The countermeasure constituted passive exposure to blue-enriched polychromatic lighting for three 20-minute intervals, which included 10 minutes of exercise and occurred before and twice during their shifts. Alertness, performance and mood were evaluated.
RESULTS


Flight controllers reported being significantly more alert (p < 0.0001) and happy (p = 0.003) and had faster reaction times (10% slowest responses; p < 0.05) during the countermeasure condition compared to control.
CONCLUSIONS


The combined light and exercise countermeasure improved alertness, performance and mood in shift workers overnight. Further research is necessary to determine their relative contribution.",2020,"RESULTS


Flight controllers reported being significantly more alert (p < 0.0001) and happy (p = 0.003) and had faster reaction times (10% slowest responses; p < 0.05) during the countermeasure condition compared to control.
",['Twenty NASA flight controllers were studied for two blocks of nightshifts in ISS mission control'],"['Short Wavelength-enriched White Light and Exercise', 'combined short-wavelength-enriched white light and exercise fatigue countermeasure', 'combined light and exercise countermeasure', 'control or countermeasure condition']","['faster reaction times', 'alertness, performance and mood', 'Alertness, performance and mood']","[{'cui': 'C0242776', 'cui_str': 'National Aeronautics and Space Administration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C1740819', 'cui_str': 'Idiopathic short stature'}, {'cui': 'C0026219', 'cui_str': 'Missions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.0459039,"RESULTS


Flight controllers reported being significantly more alert (p < 0.0001) and happy (p = 0.003) and had faster reaction times (10% slowest responses; p < 0.05) during the countermeasure condition compared to control.
","[{'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Barger', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA (Laura K. Barger, Jason P. Sullivan, Steven W. Lockley, Charles A. Czeisler); Division of Sleep Medicine, Harvard Medical School, Boston, MA (Laura K. Barger, Steven W. Lockley, Charles A. Czeisler).""}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Sullivan', 'Affiliation': ''}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': ''}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Czeisler', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000002054']
1046,33065786,"Effects of ozone autohemotherapy on blood VEGF, TGF-β and PDGF levels after finger replantation.","BACKGROUND


The study aimed to confirm the important role of ozone autologous blood therapy (autohemotherapy) in promoting successful finger replantation and its possible influence mechanism.
METHODS


A total of 150 patients with severed finger replantation admitted to our hospital from March 2018 to March 2019 were selected. Patients were divided into observation group and control group according to different treatment methods. The observation group received additional ozone autologous blood treatment in the control group. We compared the number of white blood cells, visual analogue scale (VAS) scores, and the expression levels of vascular endothelial growth factor (VEGF), transforming growth factor-β (TGF-β), and platelet-derived growth factor (PDGF) in the two groups of patients before and after intervention. We also assessed the hospitalization time and survival time of the replanted finger in the two groups, as well as blood flow values (Vbcf).
RESULTS


Compared with the observation group on the 1st day after the operation and the control group on the 7th day after the operation, the average white blood cell count of the observation group on the 7th day after the operation was significantly increased (P<0.05), and the VAS score was significantly decreased (P<0.05).48 hours after the operation, the average Vbcf value of the replanted finger was lower than that of the contralateral healthy finger (P<0.05). Compared with the control group, the Vbcf value of the replanted fingers in the observation group was higher, and the hospitalization time and finger survival time were shorter (P<0.05). At 7 days after operation, the serum VEGF, TGF-β and PDGF levels in the observation group were significantly higher than the 1 day after operation, before the operation and the control group (P<0.05).
CONCLUSIONS


Intervention with ozone autohemotherapy after severed finger replantation can significantly increase the number of white blood cells, relieve postoperative pain, and improve the survival rate of the finger body. Ozone autohemotherapy also improves the microcirculation after anastomosis of the severed finger by up-regulating the expression of VEGF, TGF-β and PDGF in blood.",2020,"At 7 days after operation, the serum VEGF, TGF-β and PDGF levels in the observation group were significantly higher than the 1 day after operation, before the operation and the control group (P<0.05).
",['150 patients with severed finger replantation admitted to our hospital from March 2018 to March 2019 were selected'],"['additional ozone autologous blood treatment', 'ozone autohemotherapy', 'ozone autologous blood therapy (autohemotherapy', 'Ozone autohemotherapy']","['hospitalization time and finger survival time', 'blood flow values (Vbcf', 'blood VEGF, TGF-β and PDGF levels', 'number of white blood cells, visual analogue scale (VAS) scores, and the expression levels of vascular endothelial growth factor (VEGF), transforming growth factor-β (TGF-β), and platelet-derived growth factor (PDGF', 'average white blood cell count', 'VAS score', 'serum VEGF, TGF-β and PDGF levels', 'number of white blood cells, relieve postoperative pain', 'hospitalization time and survival time', 'survival rate']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264097', 'cui_str': 'Calcaneal apophysitis'}, {'cui': 'C0408894', 'cui_str': 'Reattachment of finger'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2239222', 'cui_str': 'Vascular endothelial growth factor assay'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0032200', 'cui_str': 'Platelet-derived growth factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",150.0,0.0136631,"At 7 days after operation, the serum VEGF, TGF-β and PDGF levels in the observation group were significantly higher than the 1 day after operation, before the operation and the control group (P<0.05).
","[{'ForeName': 'Shaoyi', 'Initials': 'S', 'LastName': 'He', 'Affiliation': ""Department of Anesthesiology, The Third People's Hospital of Cixi City, Cixi, China.""}, {'ForeName': 'Weiting', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Hand Surgery, The Third People's Hospital of Cixi City, Cixi, China.""}, {'ForeName': 'Jingzhao', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': ""Department of Anesthesiology, The Third People's Hospital of Cixi City, Cixi, China.""}, {'ForeName': 'Zhongbin', 'Initials': 'Z', 'LastName': 'Lai', 'Affiliation': ""Department of Anesthesiology, The Third People's Hospital of Cixi City, Cixi, China.""}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': ""Department of Anesthesiology, The Third People's Hospital of Cixi City, Cixi, China.""}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': ""Department of Anesthesiology, The Third People's Hospital of Cixi City, Cixi, China.""}, {'ForeName': 'Shuiqi', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': ""Department of Orthopedics, The Third People's Hospital of Cixi City, Cixi, China. caishuiqi123@hotmail.com.""}]",Annals of palliative medicine,['10.21037/apm-20-1467']
1047,33065791,"Effects of xipayi mouth rinse combined with minocycline on localized aggressive periodontitis' therapeutic effect and the levels of CRP, TNF-α, IL-6 in serum.","BACKGROUND


Localized aggressive periodontitis is rare periodontitis in clinical practice, which often occurs in young adults under 35 years old, seriously affecting patients' quality of life. As a tetracycline antibacterial drug, minocycline is also considered an essential choice to treat periodontal disease. However, few reports focused on the effect of xipayi mouth rinse combined with minocycline on periodontal pathogens. The goal of this study was to investigate the clinical effect of xipayi mouth rinse combined with minocycline in the treatment of localized aggressive periodontitis and its effect on the levels of CRP, TNF-α, and IL-6.
METHODS


Ninety-six patients with limited aggressive periodontitis were selected and randomly divided into two groups. Forty-eight patients in the control group were treated with xipayi mouth rinse after primary periodontal treatment. Then, 48 patients in the experimental group were treated with xipayi mouth rinse combined with minocycline after primary periodontal treatment. The periodontal probe was applied to detect periodontal plaque index (PLI), periodontal pocket depth (PD), sulcus bleeding index (SBI), gingival index (GL), and clinical attachment loss (CAL) before and after treatment in both groups of patients. ELISA was used for detecting the expression levels of CRP, TNF-α, and IL-6 in the serum of patients in two groups before and after treatment. We compared the recurrence rates of the two groups after a 1-year follow-up.
RESULTS


Compared with the control group, the PLI, PD, SBI, GL, CAL, and total masticatory efficiency of the experimental group were significantly better than those of the control group. The levels of inflammatory factors CRP, TNF-α, and IL-6 were significantly declined, and the total effective rate of treatment was significantly elevated. After follow-up, it was found there was no noticeable difference in the recurrence rate between the two groups.
CONCLUSIONS


Xipayi mouth rinse, combined with minocycline in the treatment of localized aggressive periodontitis, can significantly improve the periodontal gingival condition and reduce the level of inflammatory factors. Also, the efficacy of the treatment was significant. This experiment has provided ideas for improving the clinical treatment of patients with localized aggressive periodontitis.",2020,"The levels of inflammatory factors CRP, TNF-α, and IL-6 were significantly declined, and the total effective rate of treatment was significantly elevated.","['young adults under 35 years old', 'patients with localized aggressive periodontitis', 'Ninety-six patients with limited aggressive periodontitis', '48 patients in the experimental group']","['ELISA', 'xipayi mouth rinse combined with minocycline', 'minocycline', 'tetracycline antibacterial drug, minocycline', 'xipayi mouth rinse']","['periodontal plaque index (PLI), periodontal pocket depth (PD), sulcus bleeding index (SBI), gingival index (GL), and clinical attachment loss (CAL', 'expression levels of CRP, TNF-α, and IL-6', 'PLI, PD, SBI, GL, CAL, and total masticatory efficiency', 'recurrence rates', 'level of inflammatory factors', ""localized aggressive periodontitis' therapeutic effect and the levels of CRP, TNF-α, IL-6 in serum"", 'periodontal gingival condition', 'levels of inflammatory factors CRP, TNF-α, and IL-6', 'total effective rate of treatment', 'recurrence rate']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0001342', 'cui_str': 'Acute periodontitis'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C1744619', 'cui_str': 'Tetracycline antibiotic product'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0031094', 'cui_str': 'Periodontal pocket'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0001342', 'cui_str': 'Acute periodontitis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",96.0,0.0274725,"The levels of inflammatory factors CRP, TNF-α, and IL-6 were significantly declined, and the total effective rate of treatment was significantly elevated.","[{'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Prosthodontics, Handan Stomatological Hospital, Handan, China. fernandes2010@163.com.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': '2Department of Pediatric Dentistry, Handan Stomatological Hospital, Handan, China.'}, {'ForeName': 'Zhifang', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': '3Department of Periodontology, Handan Stomatological Hospital, Handan, China.'}, {'ForeName': 'Haijiao', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Prosthodontics, Handan Stomatological Hospital, Handan, China.'}, {'ForeName': 'Yehua', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Department of Periodontology, Handan Stomatological Hospital, Handan, China.'}, {'ForeName': 'Shanglin', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Clinical Laboratory, Handan Stomatological Hospital, Handan, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Prosthodontics, Handan Stomatological Hospital, Handan, China. 23878024@qq.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1653']
1048,33065813,Major depressive disorder with mixed features and treatment response to lurasidone: A symptom network model.,"BACKGROUND


To investigate the symptom network structure of major depressive disorder (MDD) with mixed features and implications for treatment.
METHODS


In this post-hoc analysis of a previously reported randomized trial, patients meeting DSM-IV-TR criteria for MDD presenting with two or three manic symptoms (DSM-5 mixed features specifier) were randomized to 6 weeks of double-blind treatment with lurasidone 20-60 mg/d (N = 109) or placebo (N = 100). The network structure of symptoms at baseline and their treatment moderating effects were investigated.
RESULTS


Network analyses showed that both ``elevated mood'' (YMRS item 1) and ``increased motor activity-energy'' (YMRS item 2) were associated with ``sleep disturbance'' (""bridge"" symptom) and the depressive symptom cluster. Presence of both ""elevated mood"" and ""increased motor activity-energy"" at baseline predicted significantly less improvement in MADRS and CGI-S score at week 6 with lurasidone (vs. placebo) compared to patients without these manic symptoms at baseline. The network model also showed ""rapid/pressured speech"" (YMRS item 6) at baseline predicted improvement in both manic and depressive symptoms with lurasidone vs. placebo treatment.
LIMITATIONS


This was a post-hoc analysis where findings need to be confirmed by prospective controlled studies.
CONCLUSIONS


This post-hoc analysis describes the symptom network structure of MDD with mixed features in a patient sample at study baseline. Specific manic symptoms were found to be linked to sleep disturbance (characterized as a ""bridge"" symptom), which in turn linked the manic and depressive symptom clusters. The presence (vs. absence) of the specific manic symptoms we identified moderated the antidepressant and antimanic effects of lurasidone in the treatment of MDD with mixed (subthreshold hypomanic) features.",2020,"Presence of both ""elevated mood"" and ""increased motor activity-energy"" at baseline predicted significantly less improvement in MADRS and CGI-S score at week 6 with lurasidone (vs. placebo) compared to patients without these manic symptoms at baseline.",['patients meeting DSM-IV-TR criteria for MDD presenting with two or three manic symptoms (DSM-5 mixed features specifier'],"['lurasidone', 'lurasidone 20-60\xa0mg', 'placebo', 'lurasidone (vs. placebo', 'lurasidone vs. placebo']","['motor activity-energy', 'MADRS and CGI-S score', 'sleep disturbance\'\' (""bridge"" symptom) and the depressive symptom cluster']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]",2.0,0.315016,"Presence of both ""elevated mood"" and ""increased motor activity-energy"" at baseline predicted significantly less improvement in MADRS and CGI-S score at week 6 with lurasidone (vs. placebo) compared to patients without these manic symptoms at baseline.","[{'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Goldberg', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: joseph.goldberg@mssm.edu.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Siu', 'Affiliation': 'COS and Associates Ltd., Central, Hong Kong.'}, {'ForeName': 'Yongcai', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA and Fort Lee, NJ.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Tsai', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA and Fort Lee, NJ.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Pikalov', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA and Fort Lee, NJ.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'University Hospitals Case Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Loebel', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA and Fort Lee, NJ.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.048']
1049,33066130,"Designing an Effective Front-of-Package Warning Label for Food and Drinks High in Added Sugar, Sodium, or Saturated Fat in Colombia: An Online Experiment.","Policies to require warnings on the front of food and drinks high in nutrients of concern (e.g., added sugar, sodium, or saturated fat) are becoming increasingly common as an obesity prevention strategy. Colombia, a country with growing prevalence of obesity, is considering implementing a similar policy. The objective of this study was to assess perceptions and reactions to different warning designs. We conducted a randomized experiment in an online panel of adults age > 18y ( n  = 1997). Participants were randomized to view one of four labels: a control label (barcode), an octagon warning, a circle warning, and a triangle warning. Participants viewed their randomly assigned label on a series of products and answered questions (continuous outcomes ranged from 1-4). Compared to the control, all warnings led to higher perceived message effectiveness (increase in mean from 1.79 in the control to 2.59-2.65 in the warning conditions,  p  < 0.001), a higher percentage of participants who correctly identified products high in nutrients of concern (from 48% in the control condition to 84-89% in the warning conditions,  p  < 0.001), and reduced intentions to purchases these products (decrease in mean from 2.59 to 1.99-2.01 in the warning conditions,  p  < 0.001). Relative to the control, warnings performed similarly across education levels, suggesting this policy would be equitable in Colombia. Looking at differences by warning type, the pattern of results suggested that the octagon warnings performed best. After viewing all label types, 49% of participants selected the octagon warning as the one that most discouraged them from consuming products high in nutrients of concern, while 21% and 27% selected the circle and triangle warning. Colombian policymakers should consider the octagon warning as part of a front-of-package labeling policy to help consumers identify and reduce consumption of foods and drinks high in nutrients of concern.",2020,"Compared to the control, all warnings led to higher perceived message effectiveness (increase in mean from 1.79 in the control to 2.59-2.65 in the warning conditions,  p  < 0.001), a higher percentage of participants who correctly identified products high in nutrients of concern (from 48% in the control condition to 84-89% in the warning conditions,  p  < 0.001), and reduced intentions to purchases these products (decrease in mean from 2.59 to 1.99-2.01 in the warning conditions,  p  < 0.001).",['online panel of adults age '],"['control label (barcode), an octagon warning, a circle warning, and a triangle warning']",['message effectiveness'],"[{'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0350172,"Compared to the control, all warnings led to higher perceived message effectiveness (increase in mean from 1.79 in the control to 2.59-2.65 in the warning conditions,  p  < 0.001), a higher percentage of participants who correctly identified products high in nutrients of concern (from 48% in the control condition to 84-89% in the warning conditions,  p  < 0.001), and reduced intentions to purchases these products (decrease in mean from 2.59 to 1.99-2.01 in the warning conditions,  p  < 0.001).","[{'ForeName': 'Lindsey Smith', 'Initials': 'LS', 'LastName': 'Taillie', 'Affiliation': 'Carolina Population Center and Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, Lineberger Comprehensive Cancer Center, Carolina Population Center, University of North Carolina, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Luis Fernando', 'Initials': 'LF', 'LastName': 'Gómez', 'Affiliation': 'Facultad de Medicina, Pontificia Universidad Javeriana, 110231 Bogotá, Colombia.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Higgins', 'Affiliation': 'Carolina Population Center, University of North Carolina, Chapel Hill, NC 27516, USA.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Bercholz', 'Affiliation': 'Carolina Population Center, University of North Carolina, Chapel Hill, NC 27516, USA.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Murukutla', 'Affiliation': 'Vital Strategies, New York, NY 27599, USA.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Mora-Plazas', 'Affiliation': 'Departamento de Nutrición Humana, Universidad Nacional de Colombia, 11001 Bogotá, Colombia.'}]",Nutrients,['10.3390/nu12103124']
1050,33066213,Oxygenation before Endoscopic Sedation Reduces the Hypoxic Event during Endoscopy in Elderly Patients: A Randomized Controlled Trial.,"BACKGROUND


Sedation endoscopy increases patient and examiner satisfaction but involves complications. The most serious complication is hypoxia, the risk factors for which are old age, obesity, and American Society of Anesthesiologists physical status of 3 or greater. However, clear evidence of oxygenation during sedation endoscopy for elderly people is lacking in US, European, and Korean guidelines.
METHOD


This study was conducted for 1 year starting in August 2018 to evaluate whether pre-oxygenation use 1 min before sedation endoscopy could reduce the incidence of hypoxia in patients older than 65 years of age. A total of 70 patients were divided into the non-oxygenated group ( n  = 35; control group) and oxygen-treated group ( n  = 35; experimental group) during endoscopy.
RESULT


The incidence of hypoxia was 28 (80%) in the control group versus 0 (0%) in the pre-oxygenated group. Factors related to hypoxia in the non-oxygenated group were a relatively high dose of midazolam and concomitant injection with narcotic analgesics such as pethidine.
CONCLUSION


The incidence of hypoxia during sedation endoscopy is high in patients over 65 years, but oxygenation during endoscopic sedation in elderly people can significantly reduce the incidence of intraprocedural hypoxic events.",2020,The incidence of hypoxia was 28 (80%) in the control group versus 0 (0%) in the pre-oxygenated group.,"['70 patients', 'Elderly Patients', 'patients older than 65 years of age']","['oxygen-treated group ( n  = 35; experimental group) during endoscopy', 'pre-oxygenation use 1 min before sedation endoscopy', 'midazolam']",['incidence of hypoxia'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]",70.0,0.0672732,The incidence of hypoxia was 28 (80%) in the control group versus 0 (0%) in the pre-oxygenated group.,"[{'ForeName': 'Hyunil', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Ilsan-ro 20, Wonju 26426, Korea.'}, {'ForeName': 'Jeong Nam', 'Initials': 'JN', 'LastName': 'Hyun', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Ilsan-ro 20, Wonju 26426, Korea.'}, {'ForeName': 'Kyong Joo', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Ilsan-ro 20, Wonju 26426, Korea.'}, {'ForeName': 'Hyun-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Ilsan-ro 20, Wonju 26426, Korea.'}, {'ForeName': 'Hong Jun', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Ilsan-ro 20, Wonju 26426, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9103282']
1051,33066237,"Efficacy and Patient Tolerability Profiles of Probiotic Solution with Bisacodyl Versus Conventional Cleansing Solution for Bowel Preparation: A Prospective, Randomized, Controlled Trial.","Although adequate bowel preparation is essential in screening colonoscopy, patient intolerability to bowel cleansing agents is problematic. Recently, a probiotic mixture solution with bisacodyl emerged to improve patient tolerability. We investigated the efficacy, safety, and patient tolerability profiles of probiotics with bisacodyl versus conventional polyethylene glycol (PEG) solution for bowel preparation for screening colonoscopies in healthy patients in this prospective, randomized, case-control study. In total, 385 volunteers were randomly assigned to receive 2 L of water + 200 mL of probiotic solution (case group,  n  = 195) or 4 L of PEG solution (control group,  n  = 190). The efficacy of the bowel cleansing was evaluated using the Ottawa scale system, polyp detection rate, and adenoma detection rate, and the patient tolerability profiles were assessed using a questionnaire. The demographics were not significantly different between groups. When the Ottawa score for each bowel segment was stratified into an adequate vs. inadequate level (Ottawa score ≤ 3 vs. >3), there were no statistical differences between groups in each segment of the colon. There were no significant differences in the polyp and adenoma detection rates between groups (38.42% vs. 32.42,  p  = 0.30; 25.79% vs. 18.97%,  p  = 0.11). The case group showed significantly fewer events than the control group, especially nausea, vomiting, and abdominal bloating events. Regarding the overall satisfaction grade, the case group reported significantly more ""average"" scores (95% vs. 44%,  p <  0.001) and were more willing to use the same agents again (90.26% vs. 61.85%,  p <  0.001). As patient compliance with bowel preparation agents is associated with an adequate level of bowel cleansing, a probiotic solution with bisacodyl might be a new bowel preparation candidate, especially in patients who show a poor compliance with conventional bowel preparation agents.",2020,"There were no significant differences in the polyp and adenoma detection rates between groups (38.42% vs. 32.42,  p  = 0.30; 25.79% vs. 18.97%,  p  = 0.11).","['patients who show a poor compliance with conventional bowel preparation agents', '385 volunteers', 'Bowel Preparation', 'healthy patients']","['Probiotic Solution with Bisacodyl Versus Conventional Cleansing Solution', '2 L of water + 200 mL of probiotic solution (case group,  n  = 195) or 4 L of PEG solution', 'probiotics with bisacodyl versus conventional polyethylene glycol (PEG) solution']","['patient tolerability', 'nausea, vomiting, and abdominal bloating events', 'Ottawa scale system, polyp detection rate, and adenoma detection rate, and the patient tolerability profiles', 'efficacy, safety, and patient tolerability profiles', 'polyp and adenoma detection rates', 'average"" scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0005632', 'cui_str': 'Bisacodyl'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",385.0,0.0465274,"There were no significant differences in the polyp and adenoma detection rates between groups (38.42% vs. 32.42,  p  = 0.30; 25.79% vs. 18.97%,  p  = 0.11).","[{'ForeName': 'Youn I', 'Initials': 'YI', 'LastName': 'Choi', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Jong-Joon', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Jun-Won', 'Initials': 'JW', 'LastName': 'Chung', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Kyoung Oh', 'Initials': 'KO', 'LastName': 'Kim', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Yoon Jae', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Jung Ho', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Dong Kyun', 'Initials': 'DK', 'LastName': 'Park', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Kwang An', 'Initials': 'KA', 'LastName': 'Kwon', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9103286']
1052,33066334,"A Randomized, Double-Blinded, Placebo-Controlled, Clinical Study of the Effects of a Nutraceutical Combination (LEVELIP DUO ® ) on LDL Cholesterol Levels and Lipid Pattern in Subjects with Sub-Optimal Blood Cholesterol Levels (NATCOL Study).","Phytosterols and red yeast rice are largely studied cholesterol-lowering nutraceuticals, respectively inhibiting the bowel absorption and liver synthesis of cholesterol. Our aim was to test the effect of combined nutraceutical-containing phytosterols and red yeast rice vs. a placebo on the lipid profile. We performed a parallel arms, double-blind, placebo-controlled clinical trial, randomizing 88 moderately hypercholesterolemic subjects to treatment with a combined nutraceutical containing phytosterols (800 mg) and red yeast rice, standardized to contain 5 mg of monacolins from  Monascus purpureus , with added niacin (27 mg) and policosanols (10 mg) (LEVELIP DUO ® ) ,  or placebo. The mean LDL-Cholesterol (LDL-C) change at Week 8 was -32.5 ± 30.2 mg/dL (-19.8%) in the combined nutraceutical group and 2.5 ± 19.4 mg/dL (2.3%) in the placebo group. The estimated between-group difference of -39.2 mg/dL (95% CI: -48.6; -29.8) indicates a statistically significant difference between treatments in favor of the combined nutraceutical ( p  < 0.0001). Total Cholesterol (TC), non-HDL cholesterol (non-HDL-C), Apolipoprotein B, TC/HDL-C and LDL-C/HDL-C improved in a similar way in the combined nutraceutical group only. No significant changes in other clinical and laboratory parameters were observed. In conclusion, the tested combined nutraceutical was well tolerated, while significantly reducing the plasma levels of LDL-C, TC, non-HDL-C, ApoB, TC/HDL-C and LDL-C/HDL-C ratios in mildly hypercholesterolemic patients. Trial registration (ClinicalTrials.gov): NCT03739242.",2020,"Apolipoprotein B, TC/HDL-C and LDL-C/HDL-C improved in a similar way in the combined nutraceutical group only.","['mildly hypercholesterolemic patients', 'Subjects with Sub-Optimal Blood Cholesterol Levels (NATCOL Study', '88 moderately hypercholesterolemic subjects']","['Nutraceutical Combination (LEVELIP DUO ® ', 'combined nutraceutical containing phytosterols (800 mg) and red yeast rice, standardized to contain 5 mg of monacolins from  Monascus purpureus , with added niacin (27 mg) and policosanols (10 mg) (LEVELIP DUO ® ) ,  or placebo', 'combined nutraceutical-containing phytosterols and red yeast rice vs. a placebo', 'placebo', 'Placebo']","['plasma levels of LDL-C, TC, non-HDL-C, ApoB, TC/HDL-C and LDL-C/HDL-C ratios', 'Total Cholesterol (TC), non-HDL cholesterol (non-HDL-C', 'lipid profile', 'Apolipoprotein B, TC/HDL-C and LDL-C/HDL-C', 'mean LDL-Cholesterol (LDL-C) change', 'LDL Cholesterol Levels and Lipid Pattern']","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0763533', 'cui_str': 'red yeast rice'}, {'cui': 'C0997449', 'cui_str': 'Monascus purpureus'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0215278', 'cui_str': 'policosanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",88.0,0.389198,"Apolipoprotein B, TC/HDL-C and LDL-C/HDL-C improved in a similar way in the combined nutraceutical group only.","[{'ForeName': 'Arrigo F G', 'Initials': 'AFG', 'LastName': 'Cicero', 'Affiliation': 'Medical an Surgery Sciences Department, Dyslipidemia and Atherosclerosis Research Unit, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': ""D'Addato"", 'Affiliation': 'Medical an Surgery Sciences Department, Dyslipidemia and Atherosclerosis Research Unit, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Borghi', 'Affiliation': 'Medical an Surgery Sciences Department, Dyslipidemia and Atherosclerosis Research Unit, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.'}]",Nutrients,['10.3390/nu12103127']
1053,33066761,"A parallel-group, multicenter randomized, double-blinded, placebo-controlled, phase 2/3, clinical trial to test the efficacy of pyridostigmine bromide at low doses to reduce mortality or invasive mechanical ventilation in adults with severe SARS-CoV-2 infection: the Pyridostigmine In Severe COvid-19 (PISCO) trial protocol.","BACKGROUND


Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the causative agent of coronavirus disease 2019 (COVID-19), may lead to severe systemic inflammatory response, pulmonary damage, and even acute respiratory distress syndrome (ARDS). This in turn may result in respiratory failure and in death. Experimentally, acetylcholine (ACh) modulates the acute inflammatory response, a neuro-immune mechanism known as the inflammatory reflex. Recent clinical evidence suggest that electrical and chemical stimulation of the inflammatory reflex may reduce the burden of inflammation in chronic inflammatory diseases. Pyridostigmine (PDG), an ACh-esterase inhibitor (i-ACh-e), increases the half-life of endogenous ACh, therefore mimicking the inflammatory reflex. This clinical trial is aimed at evaluating if add-on of PDG leads to a decrease of invasive mechanical ventilation and death among patients with severe COVID-19.
METHODS


A parallel-group, multicenter, randomized, double-blinded, placebo-controlled, phase 2/3 clinical trial to test the efficacy of pyridostigmine bromide 60 mg/day P.O. to reduce the need for invasive mechanical ventilation and mortality in hospitalized patients with severe COVID-19.
DISCUSSION


This study will provide preliminary evidence of whether or not -by decreasing systemic inflammation- add-on PDG can improve clinical outcomes in patients with severe COVID-19.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04343963 (registered on April 14, 2020).",2020,"This study will provide preliminary evidence of whether or not -by decreasing systemic inflammation- add-on PDG can improve clinical outcomes in patients with severe COVID-19.
","['Severe acute respiratory syndrome coronavirus 2', 'patients with severe COVID-19', 'hospitalized patients with severe COVID-19', 'adults with severe SARS-CoV-2 infection']","['acetylcholine (ACh', 'Pyridostigmine', 'pyridostigmine bromide', 'placebo', 'Pyridostigmine (PDG']","['invasive mechanical ventilation and death', 'mortality or invasive mechanical ventilation']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0034261', 'cui_str': 'Pyridostigmine'}, {'cui': 'C0034262', 'cui_str': 'Pyridostigmine bromide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.747485,"This study will provide preliminary evidence of whether or not -by decreasing systemic inflammation- add-on PDG can improve clinical outcomes in patients with severe COVID-19.
","[{'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Fragoso-Saavedra', 'Affiliation': 'Programa de Estudios Combinados en Medicina (MD/PhD program), Universidad Nacional Autónoma de Mexico, Mexico City, Mexico.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Iruegas-Nunez', 'Affiliation': 'Departamento de Neurología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Quintero-Villegas', 'Affiliation': 'Internal Medicine Residency Training Program, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'H Benjamín', 'Initials': 'HB', 'LastName': 'García-González', 'Affiliation': 'Internal Medicine Residency Training Program, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Nuñez', 'Affiliation': 'Internal Medicine Residency Training Program, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Sergio L', 'Initials': 'SL', 'LastName': 'Carbajal-Morelos', 'Affiliation': 'Internal Medicine Residency Training Program, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Belem M', 'Initials': 'BM', 'LastName': 'Audelo-Cruz', 'Affiliation': 'Departamento de Neurología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Sarahi', 'Initials': 'S', 'LastName': 'Arias-Martínez', 'Affiliation': 'Departamento de Neurología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Yanink', 'Initials': 'Y', 'LastName': 'Caro-Vega', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Calva', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Luqueño-Martínez', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'González-Duarte', 'Affiliation': 'Departamento de Neurología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Crabtree-Ramírez', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Crispín', 'Affiliation': 'Departamento de e Inmunología y Reumatología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Sierra-Madero', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Pablo F', 'Initials': 'PF', 'LastName': 'Belaunzarán-Zamudio', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Sergio I', 'Initials': 'SI', 'LastName': 'Valdés-Ferrer', 'Affiliation': 'Departamento de Neurología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico. sergio.valdesf@incmnsz.mx.'}]",BMC infectious diseases,['10.1186/s12879-020-05485-7']
1054,33066773,Effectiveness of a family-centered behavioral and educational counselling approach to improve periodontal health of pregnant women: a randomized controlled trial.,"BACKGROUND


Poor oral hygiene and high hormone levels during pregnancy can lead to a deterioration in periodontal health. This study assessed the effectiveness of a family-centered behavioral and educational counselling program on improving the periodontal health of women during pregnancy and postpartum.
METHODS


A randomized controlled trial was conducted among pregnant women (10th-22nd gestational week) and their husbands. Participating families were randomized into test and control groups. Intervention in the test group included explanation of oral health education (OHE) pamphlets, oral hygiene instruction, individualized feedback, and proposed solutions to overcome barriers in self-care. Reinforcements were implemented in the 3rd trimester of pregnancy and six months postpartum. In the control group, only OHE pamphlets were distributed. The assessed outcomes were bleeding on probing (BOP), periodontal pocket (Poc), loss of clinical attachment (LoA), and Visible Plaque Index (VPI). The data collection was carried out at baseline (T 0 ), in the 32nd gestational week (T 1 ), and 12 months postpartum (T 2 ).
RESULTS


Altogether 589 pregnant women were recruited, and 369 attended all three visits (test:188; control:181). In the test group, the mean VPI score at T 0  was 0.19, which decreased to 0.14 at T 1  and 0.15 at T 2 . In the control group, the mean VPI decreased from 0.19 at T 0  to 0.16 at T 1 , but increased to 0.22 at T 2 . A main effect of time and intervention and an interaction between time and intervention were detected (all p < 0.05), indicating that the intervention effect differed between T 1  and T 2 . The test group showed a significantly greater decrease over time than the control group did. Similarly, the mean BOP% decreased more significantly over time in the test group (T 0 :57%, T 1 :46%, T 2 :35%) than in the control group (T 0 :58%, T 1 :52%, T 2 :46%). For Poc and LoA, there were improvements in both study groups at 12 months postpartum, compared with during pregnancy (p < 0.001).
CONCLUSIONS


Providing family-centered, behavioral, and educational counselling to pregnant women at an early stage of pregnancy and with reinforcements can improve their oral hygiene and reduce gingival inflammation. The effect can be sustained over an extended period and is greater than that of distributing oral health leaflets alone.
TRIAL REGISTRATION


Clinicaltrials.gov , #NCT02937194. Registered 18 October 2016. Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02937194?cond=Family-centered+oral+health+promotion+for+new+parents+and+their+infants&draw=2&rank=1.",2020,"A main effect of time and intervention and an interaction between time and intervention were detected (all p < 0.05), indicating that the intervention effect differed between T 1  and T 2 .","['pregnant women', 'women during pregnancy and postpartum', 'Altogether 589 pregnant women were recruited, and 369 attended all three visits (test:188; control:181', 'pregnant women (10th-22nd gestational week) and their husbands']","['family-centered behavioral and educational counselling approach', 'family-centered behavioral and educational counselling program', 'oral health education (OHE) pamphlets, oral hygiene instruction, individualized feedback, and proposed solutions to overcome barriers in self-care']","['mean VPI', 'mean VPI score', 'periodontal health', 'mean BOP', 'Poc), loss of clinical attachment (LoA), and Visible Plaque Index (VPI', 'bleeding on probing (BOP), periodontal pocket', 'oral hygiene and reduce gingival inflammation']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0242664', 'cui_str': 'Husband'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018703', 'cui_str': 'Oral health education'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0031094', 'cui_str': 'Periodontal pocket'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}]",589.0,0.0573875,"A main effect of time and intervention and an interaction between time and intervention were detected (all p < 0.05), indicating that the intervention effect differed between T 1  and T 2 .","[{'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Dental Public Health, Faculty of Dentistry, The University of Hong Kong, Pokfulam, Hong Kong, SAR, China.'}, {'ForeName': 'Weiye', 'Initials': 'W', 'LastName': 'Wen', 'Affiliation': 'Dental Public Health, Faculty of Dentistry, The University of Hong Kong, Pokfulam, Hong Kong, SAR, China.'}, {'ForeName': 'Ka Fung', 'Initials': 'KF', 'LastName': 'Yu', 'Affiliation': 'Dental Public Health, Faculty of Dentistry, The University of Hong Kong, Pokfulam, Hong Kong, SAR, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Dental Public Health, Faculty of Dentistry, The University of Hong Kong, Pokfulam, Hong Kong, SAR, China.'}, {'ForeName': 'Edward Chin Man', 'Initials': 'ECM', 'LastName': 'Lo', 'Affiliation': 'Dental Public Health, Faculty of Dentistry, The University of Hong Kong, Pokfulam, Hong Kong, SAR, China.'}, {'ForeName': 'May Chun Mei', 'Initials': 'MCM', 'LastName': 'Wong', 'Affiliation': 'Dental Public Health, Faculty of Dentistry, The University of Hong Kong, Pokfulam, Hong Kong, SAR, China. mcmwong@hku.hk.'}]",BMC oral health,['10.1186/s12903-020-01265-6']
1055,33066794,Ticagrelor monotherapy in patients with concomitant diabetes mellitus and chronic kidney disease: a post hoc analysis of the GLOBAL LEADERS trial.,"BACKGROUND


Patients with both diabetes mellitus (DM) and chronic kidney disease (CKD) are a subpopulation characterized by ultrahigh ischemic and bleeding risk after percutaneous coronary intervention. There are limited data on the impact of ticagrelor monotherapy among these patients.
METHODS


In this post hoc analysis of the GLOBAL-LEADERS trial, the treatment effects of the experimental (one-month dual-antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus the reference regimen (12-month DAPT followed by 12-month aspirin alone) were analyzed according to DM/CKD status. The primary endpoint was a composite endpoint of all-cause death or new Q-wave myocardial infarction at 2-years. The patient-oriented composite endpoint (POCE) was defined as the composite of all-cause death, any stroke, site-reported MI and any revascularization, whereas net adverse clinical events (NACE) combined POCE with BARC type 3 or 5 bleeding events.
RESULTS


At 2 years, the DM + /CKD + patients had significantly higher incidences of the primary endpoint (9.5% versus 3.1%, adjusted HR 2.16; 95% CI [1.66-2.80], p < 0.001), BARC type 3 or 5 bleeding events, stroke, site-reported myocardial infraction, all revascularization, POCE, and NACE, compared with the DM-/CKD- patients. Among the DM + /CKD + patients, after adjustment, there were no significant differences in the primary endpoints between the experimental and reference regimen; however, the experimental regimen was associated with lower rates of POCE (20.6% versus 25.9%, HR 0.74; 95% CI [0.55-0.99], p = 0.043, p interaction  = 0.155) and NACE (22.7% versus 28.3%, HR 0.75; 95% CI [0.56-0.99], p = 0.044, p interaction  = 0.310), which was mainly driven by a lower rate of all revascularization, as compared with the reference regimen. The landmark analysis showed that while the experimental and reference regimen had similar rates of all the clinical endpoints during the first year, the experimental regimen was associated with significantly lower rates of POCE (5.8% versus 11.0%, HR 0.49; 95% CI [0.29-0.82], p = 0.007, p interaction  = 0.040) and NACE (5.8% versus 11.2%, HR 0.48; 95% CI [0.29-0.82], p = 0.007, p interaction  = 0.013) in the second year.
CONCLUSION


Among patients with both DM and CKD, ticagrelor monotherapy was not associated with lower rates of all-cause death or new Q-wave, or major bleeding complications; however, it was associated with lower rates of POCE and NACE. These findings should be interpreted as hypothesis-generating.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov (NCT01813435).",2020,"ticagrelor monotherapy was not associated with lower rates of all-cause death or new Q-wave, or major bleeding complications; however, it was associated with lower rates of POCE and NACE.","['Patients with both diabetes mellitus (DM) and chronic kidney disease (CKD', 'patients with concomitant diabetes mellitus and chronic kidney disease', 'patients with both DM and CKD']","['Ticagrelor monotherapy', 'ticagrelor monotherapy']","['net adverse clinical events (NACE) combined POCE with BARC type 3 or 5 bleeding events', 'rates of POCE', 'BARC type 3 or 5 bleeding events, stroke, site-reported myocardial infraction, all revascularization, POCE, and NACE', 'composite endpoint of all-cause death or new Q-wave myocardial infarction at 2-years', 'NACE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0429089', 'cui_str': 'Electrocardiogram Q waves'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.144396,"ticagrelor monotherapy was not associated with lower rates of all-cause death or new Q-wave, or major bleeding complications; however, it was associated with lower rates of POCE and NACE.","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ""Department of Cardiology, Xijing hospital, Xi'an, China.""}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Xijing hospital, Xi'an, China.""}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne University, ACTION Study Group, Institute of Cardiology, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Department of Cardiology, Royal Blackburn Hospital, Blackburn, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haude', 'Affiliation': 'Department of Cardiology, Rheinland Klinikum Neuss, Lukaskrankenhaus, Neuss, Germany.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Slagboom', 'Affiliation': 'OLVG, Amsterdam, Netherlands.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'van Geuns', 'Affiliation': 'Department of Cardiology, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heart Center, Bad Nauheim, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT, French Alliance for Cardiovascular Trials, Paris, France.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland. patrick.w.j.c.serruys@gmail.com.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01153-x']
1056,33066857,"Effectiveness and safety of electrical moxibustion for knee osteoarthritis: A multicenter, randomized, assessor-blinded, parallel-group clinical trial.","BACKGROUND


The prevalence of knee osteoarthritis (KOA) is increasing, and it has emerged as a major health issue. Studies have been reported that moxibustion is effective for treating KOA, but conventional moxibustion is difficult to control the intensity of stimulation and causes smoke, harmful gases, or odors. An electrical moxibustion (EM) device was developed to solve these problems, so we conducted this study to evaluate the effectiveness and safety of EM as a treatment for KOA.
METHODS


This is a multicenter, randomized, assessor-blinded, parallel-group clinical trial. Participants with KOA were randomly allocated into EM, traditional indirect moxibustion (TIM), or usual care groups. The moxibustion groups were received 12 sessions of moxibustion treatment at six acupuncture points (ST36, ST35, ST34, SP9, EX-LE4, SP10) over a period of 6 weeks. The usual care group was received usual treatment and self-care. The primary outcome was the degree of pain measured by numerical rating scale (NRS). The second outcomes were measured using visual analog scale, Korean version of the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life five dimension five level scale, and warm sense threshold and heat pain threshold. For safety assessment, laboratory test and adverse events (AEs) were recorded.
RESULTS


A total of 138 participants were assigned. While there was no significant NRS change in the usual care, EM and TIM showed significant decrease after treatment. Compared to the usual care, the mean change of NRS in the EM and TIM was significantly different, but there was no significance between two groups. Regarding secondary outcomes, EM and TIM also showed significant difference compared to the usual care, but there was no significance between two groups. Regarding safety assessment, while usual care showed significant safety among three groups, EM showed seven treatment-related AEs by four participants compared TIM's 10 events by 10 participants. In addition, there was no blister caused by burns in the EM, which occurred four cases in the TIM.
CONCLUSION


This study shows that EM is effective to improve the pain and function by KOA with a certain level of safety.",2020,"Regarding secondary outcomes, EM and TIM also showed significant difference compared to the usual care, but there was no significance between two groups.","['A total of 138 participants were assigned', 'knee osteoarthritis', 'Participants with KOA']","['electrical moxibustion', 'electrical moxibustion (EM) device', 'EM, traditional indirect moxibustion (TIM), or usual care groups', 'moxibustion treatment at six acupuncture points (ST36, ST35, ST34, SP9, EX-LE4, SP10', 'usual treatment and self-care']","['For safety assessment, laboratory test and adverse events (AEs', 'Effectiveness and safety', 'visual analog scale, Korean version of the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life five dimension five level scale, and warm sense threshold and heat pain threshold', 'degree of pain measured by numerical rating scale (NRS', 'mean change of NRS in the EM and TIM']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0450533', 'cui_str': 'ST36'}, {'cui': 'C0450532', 'cui_str': 'ST35'}, {'cui': 'C0450531', 'cui_str': 'ST34'}, {'cui': 'C0450551', 'cui_str': 'SP9'}, {'cui': 'C0450552', 'cui_str': 'SP10'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}]",138.0,0.0803553,"Regarding secondary outcomes, EM and TIM also showed significant difference compared to the usual care, but there was no significance between two groups.","[{'ForeName': 'Ha-Ra', 'Initials': 'HR', 'LastName': 'Kang', 'Affiliation': 'Department of Korean Medicine, Dongguk University Graduate School, Goyang, Republic of Korea. Electronic address: gkfk29@hanmail.net.'}, {'ForeName': 'Yeon-Sun', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Acupuncture & Moxibustion, Dongguk University Ilsan Oriental Hospital, Goyang, Republic of Korea. Electronic address: ewslys@naver.com.'}, {'ForeName': 'Seon-Hye', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, Seongnam, Republic of Korea. Electronic address: seonhye620@hanmail.net.'}, {'ForeName': 'Won-Suk', 'Initials': 'WS', 'LastName': 'Sung', 'Affiliation': 'Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, Seongnam, Republic of Korea. Electronic address: 1984sws@hanmail.net.'}, {'ForeName': 'Chan-Yung', 'Initials': 'CY', 'LastName': 'Jung', 'Affiliation': 'Institute of Oriental Medicine, College of Korean Medicine, Dongguk University, Goyang, Republic of Korea. Electronic address: yyoung81@hanmail.net.'}, {'ForeName': 'Hyun-Seok', 'Initials': 'HS', 'LastName': 'Cho', 'Affiliation': 'Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, Seongnam, Republic of Korea. Electronic address: good-doctor@hanmail.net.'}, {'ForeName': 'Seung-Deok', 'Initials': 'SD', 'LastName': 'Lee', 'Affiliation': 'Institute of Oriental Medicine, College of Korean Medicine, Dongguk University, Goyang, Republic of Korea. Electronic address: chunkman@dongguk.edu.'}, {'ForeName': 'Kyung-Ho', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': 'Department of Acupuncture & Moxibustion, Dongguk University Ilsan Oriental Hospital, Goyang, Republic of Korea. Electronic address: omdkkh@hanmail.net.'}, {'ForeName': 'Eun-Jung', 'Initials': 'EJ', 'LastName': 'Kim', 'Affiliation': 'Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, Seongnam, Republic of Korea. Electronic address: hanijjung@naver.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102523']
1057,33066859,Evaluation of the effect of vitamin D3 supplementation on quantitative and qualitative parameters of spermograms and hormones in infertile men: A Randomized controlled trial.,"BACKGROUND


25-Hydroxy Vitamin D3 is known to have an effect on reproductive system in both genders and may change the semen parameters in men.
OBJECTIVE


Our study aimed to evaluate the effect of oral vitamin D3 supplementation on spermogram quantitative and qualitative parameters in infertile men.
MATERIALS AND METHODS


This study was a triple-blind randomized controlled trial involving 62 infertile men with impaired spermatogonial tests. They were randomly divided into placebo and D3-supplemented groups. Spermograms and tests for LH (Luteinizing Hormone), FSH (Follicle Stimulating Hormone), TT (Total Testosterone), FT (Free Testosterone), SHBG (Sex Hormone Bonding Globulin), FAI (Free Androgen Index) and vitamin D3 levels were performed before and after the intervention.
RESULTS


There were no significant differences between the two groups in parameters of the spermograms or serum levels of LH, FSH, TT, and FAI. In the intervention group, SHBG was significantly decreased after intervention (p = 0.01) and there was a significant increase in FT in the placebo group (p = 0.03).
CONCLUSION


The intake of vitamin D3 did not change the quality and quantity of spermograms and serum levels of LH, FSH, TT, and FAI but affected FT and SHBG. Further studies are still needed to clarify the biological role of vitamin D3 on fertility particularly on male fertility. This study lays a foundation for more extensive studies on male infertility.",2020,"The intake of vitamin D3 did not change the quality and quantity of spermograms and serum levels of LH, FSH, TT, and FAI but affected FT and SHBG.","['men', 'male infertility', 'infertile men', '62 infertile men with impaired spermatogonial tests']","['oral vitamin D3 supplementation', 'LH', 'vitamin D3', 'placebo', 'vitamin D3 supplementation']","['quality and quantity of spermograms and serum levels of LH, FSH, TT, and FAI but affected FT and SHBG', 'spermogram quantitative and qualitative parameters', 'FT', 'Luteinizing Hormone), FSH (Follicle Stimulating Hormone), TT (Total Testosterone), FT (Free Testosterone), SHBG (Sex Hormone Bonding Globulin), FAI (Free Androgen Index) and vitamin D3 levels', 'spermograms or serum levels of LH, FSH, TT, and FAI', 'SHBG']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0021364', 'cui_str': 'Male infertility'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0017649', 'cui_str': 'Globulin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",62.0,0.172834,"The intake of vitamin D3 did not change the quality and quantity of spermograms and serum levels of LH, FSH, TT, and FAI but affected FT and SHBG.","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Amini', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran. Electronic address: amini.l@iums.ac.ir.'}, {'ForeName': 'Robabe', 'Initials': 'R', 'LastName': 'Mohammadbeigi', 'Affiliation': 'Clinical Research Development Unit (ShACkRDU), Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Vafa', 'Affiliation': 'School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Haghani', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Vahedian-Azimi', 'Affiliation': 'Trauma Research Center, Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Karimi', 'Affiliation': 'Behavioral Sciences Research Center, Life Style Institute, Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shayesteh', 'Initials': 'S', 'LastName': 'Jahanfar', 'Affiliation': 'MPH Program, Central Michigan University, USA.'}, {'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Jamialahmadi', 'Affiliation': 'Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Food Science and Technology, Quchan Branch, Islamic Azad University, Quchan, Iran; Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Talebi', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran. Electronic address: afsanehtalebi68@gmail.com.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': ""Halal Research Center of IRI, FDA, Tehran, Iran; Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad 9177948564, Iran; Polish Mother's Memorial Hospital Research Institute (PMMHRI), 93338 Lodz, Poland. Electronic address: sahebkara@mums.ac.ir.""}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102529']
1058,33066862,Efficacy of Nardostachys jatamansi (D.Don) DC in essential hypertension: A randomized controlled study.,"BACKGROUND


Nardostachys jatamansi (D.Don) DC, commonly known as muskroot and Indian spikenard, is a small, perennial, flowering, rhizomatous species of the Caprifoliaceae family. Nardostachys jatamansi (D.Don) DC (Sumbul-ut-teeb) has been used in Unani Medicine since antiquity. It is one of the important drugs mentioned by Ibn-e-Sina (Avicenna) in his treatise ""Kitab al-Adwiya al- Qalbiya"" for cardiac diseases. The drug has been shown to exhibit anxiolytic, sedative, antispasmodic, tranquillizing, and anti hypertensive activity.
AIM


The aim of the present study was to examine the efficacy of Nardostachys jatamansi in reducing blood pressure in hypertensive patients.
METHODS


The single blind randomized, placebo controlled study was conducted with 40 patients aged between 35-70 years. The participants were randomly allocated to receive either a total of 3 g of N. Jatamansi (1capsule 3 times a day) or placebo for 4 weeks. Patients using ≤ 2 antihypertensive drugs with stage 1 hypertension were included in the study. Systolic and diastolic Blood pressure was recorded at baseline and at every week for four weeks. MINICHAL score (for Quality of Life) was recorded at baseline and at the end of the trial.
RESULTS


After the four weeks of treatment, there was a statistically significant reduction in average systolic blood pressure 144.20 ± 11.35 mmHg (CI, 138.89-149.51) to 134.30 ± 10.08 mmHg (CI, 129.58-139.02), p < 0.001) and diastolic blood pressure (94.9. ± 3.4 mmHg (CI 93.30-96.49) to 83.10 ± 5.29 mmHg (CI 80.62-85.57), p < 0.001) in the N. Jatamansi group whereas there was no significant difference in systolic blood pressure (143.40 ± 8.39 mmHg (CI, 139.47-147.33) to 142. ± 11.68 mmHg (CI, 136.53-147.47) p = 0.148) and diastolic blood pressure 95.10 ± 3.70 mmHg (CI, 93.37-96.83) to 94.80 ± 3.69 mmHg, (CI93.07-96.52) p = 0.186) in placebo group. A comparison between baseline and post treatment, MINICHAL score in N. Jatamansi group showed significant reduction 10.85 ± 1.27 (CI, 10.25-11.44) to 6.20 ± 1.77, (CI, 5.37-7.02) p < 0.001) whereas there was no significant difference in placebo group 11.05 ± 1.50 (CI, 10.34-11.75) to 10.85 ± 1.26, 95 % (CI, 10.25-11.44) p = 0.103).
CONCLUSION


The present findings suggest that N. Jatamansi is effective in reducing both systolic and diastolic blood pressure in essential hypertension. Moreover studies on efficacy of different doses and treatment duration of test drug are required to finetune these observations.",2020,"After the four weeks of treatment, there was a statistically significant reduction in average systolic blood pressure 144.20 ± 11.35 mmHg (CI, 138.89-149.51) to 134.30 ± 10.08 mmHg (CI, 129.58-139.02), p < 0.001) and diastolic blood pressure (94.9. ± 3.4 mmHg (CI 93.30-96.49) to 83.10 ± 5.29 mmHg (CI 80.62-85.57), p < 0.001) in the N. Jatamansi group whereas there was no significant difference in systolic blood pressure (143.40 ± 8.39 mmHg (CI, 139.47-147.33) to 142.","['Patients using ≤ 2 antihypertensive drugs with stage 1 hypertension were included in the study', '40 patients aged between 35-70 years', 'essential hypertension', 'hypertensive patients']","['Nardostachys jatamansi', 'placebo', 'Nardostachys jatamansi (D.Don) DC']","['systolic and diastolic blood pressure', 'blood pressure', 'systolic blood pressure', 'Systolic and diastolic Blood pressure', 'diastolic blood pressure', 'average systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C1021351', 'cui_str': 'Nardostachys'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1282151', 'cui_str': 'Average systolic blood pressure'}]",40.0,0.25321,"After the four weeks of treatment, there was a statistically significant reduction in average systolic blood pressure 144.20 ± 11.35 mmHg (CI, 138.89-149.51) to 134.30 ± 10.08 mmHg (CI, 129.58-139.02), p < 0.001) and diastolic blood pressure (94.9. ± 3.4 mmHg (CI 93.30-96.49) to 83.10 ± 5.29 mmHg (CI 80.62-85.57), p < 0.001) in the N. Jatamansi group whereas there was no significant difference in systolic blood pressure (143.40 ± 8.39 mmHg (CI, 139.47-147.33) to 142.","[{'ForeName': 'Muzafar Din Ahmad', 'Initials': 'MDA', 'LastName': 'Bhat', 'Affiliation': 'Dept. of Moalajat (Medicine), National Institute of Unani Medicine Bangalore 560091, India. Electronic address: drmuzaffar79@gmail.com.'}, {'ForeName': 'Shah Agaz', 'Initials': 'SA', 'LastName': 'Malik', 'Affiliation': 'Dept. of Moalajat (Medicine), National Institute of Unani Medicine Bangalore 560091, India. Electronic address: draghaz.malik@gmail.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102532']
1059,33066865,Tai Chi training for attention deficit hyperactivity disorder: A feasibility trial in college students.,"OBJECTIVE


Many young adults are affected by attention deficit hyperactivity disorder (ADHD) and often desire non-pharmacological treatment options. Mind-body techniques might serve as complementary therapies to first-line stimulant medications, but studies are limited. Tai Chi is an increasingly popular practice that integrates movement with cognitive skills relevant to ADHD. We performed a feasibility trial of Tai Chi training in undergraduates to inform the design of a fully powered randomized controlled trial (RCT).
METHOD


Undergraduates with ADHD were recruited, screened, enrolled, and assessed at baseline. They were assigned to three parallel seven-week intervention arms, Tai Chi, Active Control (cardio-aerobic fitness), and Inactive Control (no contact), with follow-up assessments. Feasibility of a larger clinical trial was evaluated, especially with respect to enrollment and retention. Additionally, potential clinical outcome measures were examined for practicality and reliability.
RESULTS


21 participants were assessed at baseline and 19 at follow-up (90 % retention). The primary clinical outcome measure, self-reported inattention symptoms (Conners' CAARS-S:L DSM-IV Inattentive Symptoms subscale), exhibited good test-retest reliability in controls (r = 0.87, n = 10) and correlated with reduced mindfulness (FFMQ acting with awareness subscale) at baseline (r = -0.74, n = 20). Class attendance and self-reported daily practice time were variable. Randomization to group classes was hindered by the college students' restricted schedules.
CONCLUSION


The high retention rate and good data quality suggest that an RCT of Tai Chi for ADHD is feasible. Further measures are identified to improve enrollment rates, adherence, and randomization procedures. Future work might extend to other young adult populations and high school students.",2020,"They were assigned to three parallel seven-week intervention arms, Tai Chi, Active Control (cardio-aerobic fitness), and Inactive Control (no contact), with follow-up assessments.","['college students', 'attention deficit hyperactivity disorder', 'young adults', 'young adult populations and high school students', 'Undergraduates with ADHD were recruited, screened, enrolled, and assessed at baseline']","['Tai Chi, Active Control (cardio-aerobic fitness), and Inactive Control (no contact), with follow-up assessments', 'Tai Chi training']","[""self-reported inattention symptoms (Conners' CAARS-S:L DSM-IV Inattentive Symptoms subscale), exhibited good test-retest reliability"", 'Class attendance and self-reported daily practice time', 'practicality and reliability', 'reduced mindfulness (FFMQ acting with awareness subscale']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",21.0,0.0515994,"They were assigned to three parallel seven-week intervention arms, Tai Chi, Active Control (cardio-aerobic fitness), and Inactive Control (no contact), with follow-up assessments.","[{'ForeName': 'Alexander K', 'Initials': 'AK', 'LastName': 'Converse', 'Affiliation': 'Waisman Center, University of Wisconsin-Madison, United States. Electronic address: akconverse@wisc.edu.'}, {'ForeName': 'Bruce P', 'Initials': 'BP', 'LastName': 'Barrett', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, United States.'}, {'ForeName': 'Betty A', 'Initials': 'BA', 'LastName': 'Chewning', 'Affiliation': 'School of Pharmacy, University of Wisconsin-Madison, United States.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Osher Center for Integrative Medicine, Harvard Medical School and Brigham and Women's Hospital, United States.""}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102538']
1060,33066868,A Longitudinal Training Study to Delineate the Specific Causal Effects of Open Monitoring Versus Focused Attention Techniques on Emotional Health.,"BACKGROUND


Emotional dysregulation is a core mechanism of mood disorders. Meditation-based interventions can ameliorate a wide range of psychological problems. However, in order to develop structured treatment and preventative protocols for emotional disorders, it is crucial to understand how different types of specific meditation practices improve emotion regulation abilities. Mindfulness-based techniques are broadly separated into two practices - open monitoring (OM) and focused attention (FA). This study directly investigated the potential practice-specific benefits of OM versus FA techniques as tools for improving emotion regulation skills from pre-to-post training.
METHOD


Novice participants were randomized into an 8-week long OM or FA intervention that was previously developed through a science of behavior change approach. Healthy emotional skills were assessed using experience sampling methodology and inventories. Participants were assessed before, during, and after the interventions to investigate if the type of training may explain longitudinal changes in emotional skills.
RESULTS


Both OM and FA attentional training practices improved acceptance of stressors and reduced distress and rumination. We also found divergent effects of OM versus FA training: Compared to OM, FA training improved abilities to use reappraisal strategy to regulate emotions in naturalistic settings at the end of 8-weeks training. FA training (versus OM) also led to greater self-regulation abilities.
CONCLUSION


Our findings suggest that a FA training has specific causal impacts on emotion regulatory skills, and it can be selectively implemented in interventions to target emotional disorders.",2020,"Compared to OM, FA training improved abilities to use reappraisal strategy to regulate emotions in naturalistic settings at the end of 8-weeks training.",['Novice participants'],"['Meditation-based interventions', 'FA training (versus OM', 'Open Monitoring Versus Focused Attention Techniques', 'OM, FA training', 'OM versus FA training', 'OM and FA attentional training practices', 'OM or FA intervention', 'OM versus FA techniques', 'FA training']","['Healthy emotional skills', 'acceptance of stressors and reduced distress and rumination', 'emotion regulation skills']",[],"[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0589098', 'cui_str': 'Focused attention'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.0188353,"Compared to OM, FA training improved abilities to use reappraisal strategy to regulate emotions in naturalistic settings at the end of 8-weeks training.","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Lohani', 'Affiliation': 'Department of Educational Psychology, University of Utah, United States. Electronic address: Monika.Lohani@utah.edu.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'McElvaine', 'Affiliation': 'Human Development and Family Studies, Oregon State University, United States.'}, {'ForeName': 'Brennan', 'Initials': 'B', 'LastName': 'Payne', 'Affiliation': 'Department of Psychology, University of Utah, United States.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Mitcheom', 'Affiliation': 'Mindfulness Center, Brown University School of Public Health, United States.'}, {'ForeName': 'Willoughby', 'Initials': 'W', 'LastName': 'Britton', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School, Brown University, United States.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102525']
1061,33066869,Folic acid and vitamin B12 supplementation in subjects with type 2 diabetes mellitus: A multi-arm randomized controlled clinical trial.,"OBJECTIVE


This study was conducted to investigate and compare the effects of add-on folic acid and vitamin B12 supplementation on glycaemic control, insulin resistance and serum lipid profile in subjects with type 2 diabetes mellitus.
STUDY DESIGN & INTERVENTION


This study was a randomized, multi-arm, open-label clinical trial. 80 patients with type 2 diabetes and on stable oral antidiabetics were enrolled and 20 patients each were randomly allocated to one of the four groups - Group A: add-on Folic acid (5 mg/day); Group B: add-on Methylcobalamin (500 mcg/day); Group C: add-on Folic acid (5 mg/day) + Methylcobalamin (500 mcg/day) and Group D: Standard oral anti-diabetic drugs. The patients were followed up after 8 weeks.
RESULTS


HbA1c improved significantly in Groups B and C [median changes from baseline - 1.2 % (- 13 mmol/mol) and - 1.5 % (- 16 mmol/mol) respectively, p values 0.04 and 0.02 respectively] compared to Group D. Groups B and C also showed significant improvements in plasma insulin, insulin resistance and serum adiponectin compared to Group D. Serum homocysteine declined significantly in all three groups with add-on supplementation compared to standard treatment. No improvement in the lipid profile was noted in any of the groups.
CONCLUSIONS


Add-on supplementation with vitamin B12 improved glycaemic control and insulin resistance in patients with type 2 diabetes mellitus.",2020,"No improvement in the lipid profile was noted in any of the groups.
","['patients with type 2 diabetes mellitus', 'subjects with type 2 diabetes mellitus', '80 patients with type 2 diabetes and on stable oral antidiabetics were enrolled and 20 patients each']","['Folic acid and vitamin B12 supplementation', 'vitamin B12', 'Folic acid (5\u202fmg/day); Group B: add-on Methylcobalamin', 'folic acid and vitamin B12 supplementation', 'Folic acid (5\u202fmg/day) + Methylcobalamin (500 mcg/day) and Group D: Standard oral anti-diabetic drugs']","['glycaemic control, insulin resistance and serum lipid profile', 'plasma insulin, insulin resistance and serum adiponectin', 'lipid profile', 'Serum homocysteine', 'glycaemic control and insulin resistance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C4524262', 'cui_str': 'Vitamin B12 supplementation'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0065844', 'cui_str': 'mecobalamin'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439426', 'cui_str': 'ug/day'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}]",80.0,0.0647814,"No improvement in the lipid profile was noted in any of the groups.
","[{'ForeName': 'Swayamjeet', 'Initials': 'S', 'LastName': 'Satapathy', 'Affiliation': 'All India Institute of Medical Sciences, Bhubaneswar, 751019, India.'}, {'ForeName': 'Debapriya', 'Initials': 'D', 'LastName': 'Bandyopadhyay', 'Affiliation': 'Department of Biochemistry, All India Institute of Medical Sciences, Bhubaneswar, 751019, India. Electronic address: debudoc2000@gmail.com.'}, {'ForeName': 'Binod Kumar', 'Initials': 'BK', 'LastName': 'Patro', 'Affiliation': 'Department of Community Medicine and Family Medicine, All India Institute of Medical Sciences, Bhubaneswar, 751019, India.'}, {'ForeName': 'Shahnawaz', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'All India Institute of Medical Sciences, Bhubaneswar, 751019, India.'}, {'ForeName': 'Sanjukta', 'Initials': 'S', 'LastName': 'Naik', 'Affiliation': 'Department of Biochemistry, All India Institute of Medical Sciences, Bhubaneswar, 751019, India.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102526']
1062,33066879,Exploring the Economic Benefits of Modafinil for Post-Stroke Fatigue in Australia: A Cost-Effectiveness Evaluation.,"BACKGROUND


In stroke survivors, post-stroke fatigue predicts dependency in daily living and failure to return to work. Modafinil shows promise as a pharmacotherapy to reduce post-stroke fatigue and related sequelae, e.g., poorer functional and clinical outcomes.
AIMS


This study explored the cost-effectiveness of modafinil in treating post-stroke fatigue in the Australian context, by determining its incremental cost-effectiveness ratio (ICER) and by simulating the potential cost-savings on a national scale, through a re-analysis of MIDAS trial data.
METHODS


A post hoc cost-effectiveness analysis was undertaken. Part A: patient-level cost and health effect data (Multidimensional Fatigue Inventory (MFI) scores) were derived from the MIDAS trial and analysis undertaken from a health-system perspective. Part B: a secondary analysis simulated the societal impact of modafinil therapy in terms of national productivity costs.
RESULTS


Part A: Mean cost of modafinil treatment was AUD$3.60/day/patient for a minimally clinically important change (10 points) in total MFI fatigue score, i.e., AUD$0.36/day/unit change in fatigue score per patient. For the base case scenario, the ICER of using modafinil (versus placebo) was AUD$131.73 ($90.17 - 248.15, for minimum and maximum costs, respectively). Part B: The potential productivity cost-savings to society were calculated as nearly AUD$467 million over 1 year, and up to $383,471,991,248 over 10 years, from the widespread use of modafinil treatment in the Australian population of working-age stroke-survivors, representing a significant societal benefit.
CONCLUSIONS


Modafinil is a highly cost-effective treatment for post-stroke fatigue, offering significant productivity gains and potential cost-savings to society from the widespread use of modafinil treatment in the Australian population of working-age stroke-survivors.",2020,"Modafinil shows promise as a pharmacotherapy to reduce post-stroke fatigue and related sequelae, e.g., poorer functional and clinical outcomes.
","['Part B', 'Post-Stroke Fatigue in Australia']","['Modafinil', 'modafinil', 'modafinil therapy', 'modafinil (versus placebo']","['total MFI fatigue score, i.e., AUD$0.36/day/unit change in fatigue score', 'level cost and health effect data (Multidimensional Fatigue Inventory (MFI) scores', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0066677', 'cui_str': 'modafinil'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.169519,"Modafinil shows promise as a pharmacotherapy to reduce post-stroke fatigue and related sequelae, e.g., poorer functional and clinical outcomes.
","[{'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Bajorek', 'Affiliation': 'Academic Pharmacist - Graduate School of Health, University of Technology Sydney, Broadway, New South Wales 2007, Australia; Research Affiliate - Hunter Medical Research Institute, New South Wales, Australia. Electronic address: beata.bajorek@uts.edu.au.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Senior Lecturer - Deakin Health Economics, Institute for Health Transformation, Deakin University, Geelong, Victoria 3127, Australia. Electronic address: lan.gao@deakin.edu.au.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Lillicrap', 'Affiliation': 'Academic Pharmacist - Graduate School of Health, University of Technology Sydney, Broadway, New South Wales 2007, Australia; Clinical Scientist - Neurology Department, John Hunter Hospital, New Lambton Heights, New South Wales 2305, Australia. Electronic address: tom.lillicrap@newcastle.edu.au.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bivard', 'Affiliation': 'Research Affiliate - Hunter Medical Research Institute, New South Wales, Australia; Principle Research Fellow - Melbourne School of Health Sciences - Faculty of Medicine, Dentistry and Health Sciences, Victoria, Australia. Electronic address: abivard@unimelb.edu.au.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Garcia-Esperon', 'Affiliation': 'Research Affiliate - Hunter Medical Research Institute, New South Wales, Australia; Stroke Neurologist - Department of Neurology, John Hunter Hospital, New Lambton Heights, New South Wales 2305, Australia. Electronic address: Carlos.GarciaEsperon@health.nsw.gov.au.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Parsons', 'Affiliation': 'Research Affiliate - Hunter Medical Research Institute, New South Wales, Australia; Director of Neurology - Department of Neurology, Royal Melbourne Hospital, Parkville, Victoria 3052, Australia. Electronic address: Mark.Parsons@mh.org.au.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Spratt', 'Affiliation': 'Research Affiliate - Hunter Medical Research Institute, New South Wales, Australia; Stroke Neurologist - Department of Neurology, John Hunter Hospital, New Lambton Heights, New South Wales 2305, Australia; School of Biomedical Sciences, University of Newcastle, Australia. Electronic address: neil.spratt@health.nsw.gov.au.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Holliday', 'Affiliation': 'Research Affiliate - Hunter Medical Research Institute, New South Wales, Australia; School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales 2308, Australia. Electronic address: liz.holliday@newcastle.edu.au.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Levi', 'Affiliation': 'Research Affiliate - Hunter Medical Research Institute, New South Wales, Australia; The Sydney Partnership for Health, Education, Research, and Enterprise (SPHERE), Liverpool, New South Wales 2170, Australia. Electronic address: christopher.levi@unsw.edu.au.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105213']
1063,33066893,Ipsilateral Nonstenotic Carotid Disease in Minor Ischemic Stroke: an Exploratory Analysis of The POINT Randomized Clinical Trial.,"BACKGROUND AND AIM


Ipsilateral nonstenotic carotid disease is increasingly recognized as an etiology of ischemic stroke, however tailored treatment strategies are lacking. We aimed to examine clinical characteristics and treatment effects in patients with minor ischemic stroke associated with ipsilateral nonstenotic carotid disease in the Platelet Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial.
METHODS


We performed an exploratory analysis of the interaction of the treatment effects of aspirin plus clopidogrel versus aspirin monotherapy, stratified by presence of ipsilateral nonstenotic carotid disease in patients with minor ischemic stroke in the POINT trial.
RESULTS


For this exploratory analysis, 167 patients presenting with ischemic stroke and ipsilateral nonstenotic carotid disease, defined as 1%-49% carotid stenosis ipsilateral to the corresponding territory of ischemic stroke, and 833 patients no carotid disease were included. Compared to patients with no carotid disease, patients with ipsilateral nonstenotic carotid disease were older (68.5 ± 11.3 years versus 61.3 ± 12.8 years; P < 0.001), and had a higher prevalence of hypertension (76.6% versus 59.2%, P < 0.001), ischemic heart disease (13.8% versus 5.4%, P < 0.001), and tobacco use (past: 34.1% versus 25.2%, P = 0.005; present: 27.5% versus 22.8%, P = 0.005). 5.4% of patients with ipsilateral nonstenotic carotid disease had recurrent ischemic stroke within 14 days. Patients receiving dual antiplatelet therapy had a numerical reduction in recurrent ischemic stroke compared to patients receiving aspirin monotherapy, however the exploratory analysis was underpowered to detect a statistically significant difference in treatment effect (HR 0.50, 95% CI 0.18-1.40, P = 0.19).
CONCLUSION


Patients with minor ischemic stroke and ipsilateral nonstenotic carotid disease had a high risk of early stroke recurrence in the POINT trial. Dual antiplatelet therapy provided a non-statistically significant reduction in recurrent ischemic stroke with no difference in safety outcomes compared to aspirin monotherapy. Further study is needed to determine if early and short duration dual antiplatelet therapy is beneficial for all patients with ipsilateral nonstenotic carotid disease.",2020,Dual antiplatelet therapy provided a non-statistically significant reduction in recurrent ischemic stroke with no difference in safety outcomes compared to aspirin monotherapy.,"['Minor Ischemic Stroke', 'patients with minor ischemic stroke in the POINT trial', '167 patients presenting with ischemic stroke and ipsilateral nonstenotic carotid disease, defined as 1%-49% carotid stenosis ipsilateral to the corresponding territory of ischemic stroke, and 833 patients no carotid disease were included', 'patients with ipsilateral nonstenotic carotid disease', 'patients with minor ischemic stroke associated with ipsilateral nonstenotic carotid disease in the Platelet Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial', 'Patients with minor ischemic stroke and ipsilateral nonstenotic carotid disease']","['aspirin plus clopidogrel', 'aspirin monotherapy', 'dual antiplatelet therapy']","['recurrent ischemic stroke', 'high risk of early stroke recurrence', 'ipsilateral nonstenotic carotid disease', 'prevalence of hypertension', 'ischemic heart disease']","[{'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0007282', 'cui_str': 'Carotid artery stenosis'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C5191298', 'cui_str': '833'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}]",167.0,0.156056,Dual antiplatelet therapy provided a non-statistically significant reduction in recurrent ischemic stroke with no difference in safety outcomes compared to aspirin monotherapy.,"[{'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Bulwa', 'Affiliation': 'Department of Neurology, University of Chicago Medical Center, 5841 South Maryland Avenue MC 2030, Chicago, IL 60637, USA. Electronic address: zachary.bulwa@uchospitals.edu.'}, {'ForeName': 'Faddi G', 'Initials': 'FG', 'LastName': 'Saleh Velez', 'Affiliation': 'Department of Neurology, University of Chicago Medical Center, 5841 South Maryland Avenue MC 2030, Chicago, IL 60637, USA. Electronic address: faddi.salehvelez@uchospitals.edu.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Brorson', 'Affiliation': 'Department of Neurology, University of Chicago Medical Center, 5841 South Maryland Avenue MC 2030, Chicago, IL 60637, USA. Electronic address: jbrorson@neurology.bsd.uchicago.edu.'}, {'ForeName': 'Camila B', 'Initials': 'CB', 'LastName': 'Pinto', 'Affiliation': 'University of Sao Paulo, Institute of Psychology, Sao Paulo, Brazil. Electronic address: cboninpinto@gmail.com.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105115']
1064,33066895,Remote Ischemic Post-Conditioning may Improve Post-Stroke Cognitive Impairment: A Pilot Single Center Randomized Controlled Trial.,"BACKGROUND AND PURPOSE


We aimed to demonstrate the tolerability and feasibility and the effect of remote ischemic post-conditioning on cognitive functioning in patients with post-stroke cognitive impairment.
METHODS


This was a single-center, randomized, outcome-blinded, placebo-controlled trial, randomized 1:1 to receive 4 cycles of remote ischemic post-conditioning or a sham procedure for 7 days. The primary outcome measure was tolerability and feasibility of remote ischemic post-conditioning. Secondary outcomes to measure the neurological function with national institute of health stroke scale and the cognitive impairment with Montreal Cognitive Assessment scale and Alzheimer's disease assessment scale-cognitive (at baseline, 90 days, 180 days).
RESULTS


48 patients (24 RIPC and 24 Control) were recruited. remote ischemic post-conditioning was well tolerated with 90 out of 96 cycles completed in full. 4 patients experienced vascular events in the control group: 3 cerebrovascular and 1 cardiovascular event versus only 2 cerebrovascular events in the RIPC group. We showed the similar result in the neurological function with national institute of health stroke scale score with no statistically significant differences between RIPC and control group at baseline (P = 0.796) and 90 days (P = 0.401) and 180 days (P = 0.695). But compare with baseline, it was significantly difference in the control and RIPC group at 90 days (P < 0.05) and 180 days (P < 0.05). The comparison of Montreal Cognitive Assessment scale between two groups both showed that P > 0.05 at baseline which was no statistical difference, but P < 0.05 at 90 days and 180 days which were significant statistical difference. The comparison of Alzheimer's disease assessment scale-cognitive between two groups showed that P > 0.05 at baseline (P = 0.955) and 90 days (P = 0.138) was no statistical difference, but P = 0.005<0.05 at 180 days was significant statistical difference.
CONCLUSIONS


The remote ischemic post-conditioning for post-stroke cognitive impairment was well tolerated, safe and feasible. The remote ischemic post-conditioning may improve neurological and cognitive outcomes in patients with post-stroke cognitive impairment. A larger trial is warranted. (Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: ChiCTR1800015231.).",2020,"The comparison of Alzheimer's disease assessment scale-cognitive between two groups showed that P > 0.05 at baseline (P = 0.955) and 90 days (P = 0.138) was no statistical difference, but P = 0.005<0.05 at 180 days was significant statistical difference.
","['patients with post-stroke cognitive impairment', 'Post-Stroke Cognitive Impairment', '48 patients (24 RIPC and 24 Control']","['Remote Ischemic Post-Conditioning', 'placebo', 'remote ischemic post-conditioning']","['Montreal Cognitive Assessment scale', 'neurological and cognitive outcomes', 'neurological function with national institute of health stroke scale score', 'cognitive functioning', 'tolerability and feasibility of remote ischemic post-conditioning', ""neurological function with national institute of health stroke scale and the cognitive impairment with Montreal Cognitive Assessment scale and Alzheimer's disease assessment scale-cognitive"", 'vascular events', ""Alzheimer's disease assessment scale-cognitive"", 'tolerated, safe and feasible', 'cerebrovascular and 1 cardiovascular event versus only 2 cerebrovascular events', 'tolerability and feasibility']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C2936234', 'cui_str': 'Ischemic Post-Conditioning'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C2936234', 'cui_str': 'Ischemic Post-Conditioning'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.221334,"The comparison of Alzheimer's disease assessment scale-cognitive between two groups showed that P > 0.05 at baseline (P = 0.955) and 90 days (P = 0.138) was no statistical difference, but P = 0.005<0.05 at 180 days was significant statistical difference.
","[{'ForeName': 'Yue-Juan', 'Initials': 'YJ', 'LastName': 'Li', 'Affiliation': 'Yellow River Central Hospital of Yellow River Conservany Commission, Zhengzhou 450003, China.'}, {'ForeName': 'Ke-Ke', 'Initials': 'KK', 'LastName': 'Liang', 'Affiliation': ""The Department of Neurology, Zheng-Zhou University Province People's Hospital, Zhengzhou 450000, China.""}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""The Department of Neurology, Zheng-Zhou University Province People's Hospital, Zhengzhou 450000, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Pan', 'Affiliation': ""The Department of Neurology, Zheng-Zhou University Province People's Hospital, Zhengzhou 450000, China.""}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Hu', 'Affiliation': ""Director of Department. The Department of Neurology, Zheng-Zhou University Province People's Hospital, Zhengzhou 450000, China.""}, {'ForeName': 'Jian-Hua', 'Initials': 'JH', 'LastName': 'Zhao', 'Affiliation': ""The Department of Neurology, Zheng-Zhou University Province People's Hospital, Zhengzhou 450000, China. Electronic address: sjnk2011@163.com.""}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105217']
1065,33066921,Clinical Trial Based Rationale for the Successful Use of DOAC in the Treatment of Cerebral Venous Sinus Thrombosis (CVST): A Case Report.,"In cerebral venous sinus thrombosis (CVST), venous sinus occlusion increases venous pressure and disrupts venous return, resulting in progression to venous infarction and venous hemorrhage, with poor neurologic outcome. Therefore, early recanalization of the major venous sinus is critical. Anticoagulant therapy with continuous intravenous infusion of heparin and subsequent oral anticoagulant administration is the recommended first line of treatment for CVST. Some large clinical trials for venous thromboembolism (VTE) have shown that direct oral anticoagulant (DOAC) is non-inferior to the standard therapy with heparin or warfarin and causes less bleeding. In contrast, there are only a few reports on CVST treatment with DOAC such as Dabigatran, Rivaroxaban and Edoxaban describing good efficacy and safety. And there is one randomized clinical trial on DOAC treatment for CVST after acute phase. We report a successfully treated case of CVST in acute phase with progressive neurologic symptoms that achieved early recanalization of the obstructed sinus by an early switch from continuous intravenous infusion of heparin to oral Edoxaban.",2020,Some large clinical trials for venous thromboembolism (VTE) have shown that direct oral anticoagulant (DOAC) is non-inferior to the standard therapy with heparin or warfarin and causes less bleeding.,['Cerebral Venous Sinus Thrombosis (CVST'],"['CVST', 'Rivaroxaban and Edoxaban', 'heparin or warfarin', 'DOAC', 'heparin to oral Edoxaban', 'heparin']",[],"[{'cui': 'C0338573', 'cui_str': 'Cerebral venous sinus thrombosis'}]","[{'cui': 'C0338573', 'cui_str': 'Cerebral venous sinus thrombosis'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]",[],,0.0255968,Some large clinical trials for venous thromboembolism (VTE) have shown that direct oral anticoagulant (DOAC) is non-inferior to the standard therapy with heparin or warfarin and causes less bleeding.,"[{'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Bando', 'Affiliation': 'Department of Neurosurgery and Stroke Center, Shinko Hospital, 1-4-47 Wakinohamacho, Chuo-ku, Kobe, Hyogo 651-0073, Japan. Electronic address: toshiakibando4@gmail.com.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Ueno', 'Affiliation': 'Department of Neurosurgery and Stroke Center, Shinko Hospital, 1-4-47 Wakinohamacho, Chuo-ku, Kobe, Hyogo 651-0073, Japan. Electronic address: yweno@hotmail.co.jp.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Shimo', 'Affiliation': 'Department of Neurosurgery and Stroke Center, Shinko Hospital, 1-4-47 Wakinohamacho, Chuo-ku, Kobe, Hyogo 651-0073, Japan. Electronic address: dmail.smail.com@gmail.com.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kuroyama', 'Affiliation': 'Department of Neurosurgery and Stroke Center, Shinko Hospital, 1-4-47 Wakinohamacho, Chuo-ku, Kobe, Hyogo 651-0073, Japan. Electronic address: s02m025@yahoo.co.jp.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Mikami', 'Affiliation': 'Department of Neurosurgery and Stroke Center, Shinko Hospital, 1-4-47 Wakinohamacho, Chuo-ku, Kobe, Hyogo 651-0073, Japan. Electronic address: k.co28vit.puls31@gmail.com.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Hori', 'Affiliation': 'Department of Neurosurgery and Stroke Center, Shinko Hospital, 1-4-47 Wakinohamacho, Chuo-ku, Kobe, Hyogo 651-0073, Japan. Electronic address: js_ely_5050@yahoo.co.jp.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Hirai', 'Affiliation': 'Department of Neurosurgery and Stroke Center, Shinko Hospital, 1-4-47 Wakinohamacho, Chuo-ku, Kobe, Hyogo 651-0073, Japan. Electronic address: hiraio@shinkohp.or.jp.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105261']
1066,33066944,Comprehensive Use of Dynamic Electrical Neurostimulation and Botulinum Toxin Therapy in Patients with Post-Stroke Spasticity.,"BACKGROUND


Acute cerebrovascular accident poses a threat to the health of the nation. Dynamic electric neurostimulation decreases the excitability of the receptor apparatus, optimize microcirculatory processes, analgesic and antispasmodic effects.
METHODS


This article discusses the rehabilitation of 96 men and women with post-stroke spasticity, mean age of 60.51 ± 4.9 years, in the early recovery period after ischemic stroke, randomized into 4 equal groups: Group 1 received botulinum toxin therapy in combination with dynamic electric neurostimulation and basic therapy, including massage and therapeutic exercises; Group 2 -botulinum toxin therapy and basic therapy; Group 3 - dynamic electric neurostimulation and basic therapy; Group 4 - basic therapy only. Study methods included the use of the Modified Asworth Scale to assess spasticity, the Rivemead Motor Assessment test, and goniometry to assess the range of joint movements.
RESULTS


During a three-week observation, it was found that the inclusion of botulinum toxin therapy and dynamic electrical neurostimulation in the standard therapy of post-stroke spasticity in patients after ischemic stroke in the early recovery period contributed to patients' recovery.
CONCLUSIONS


Botulinum toxin therapy and dynamic electrical neurostimulation contributed to a more significant decrease in spasticity in the proximal and distal parts of the paretic upper extremity. It is also increased the amplitude of voluntary movements in the affected shoulder, elbow, and wrist joints, compared to the separate use of botulinum toxin therapy and dynamic electric neurostimulation as part of basic rehabilitation.",2020,"CONCLUSIONS


Botulinum toxin therapy and dynamic electrical neurostimulation contributed to a more significant decrease in spasticity in the proximal and distal parts of the paretic upper extremity.","['96 men and women with post-stroke spasticity, mean age of 60.51 ± 4.9 years, in the early recovery period after ischemic stroke', 'Patients with Post-Stroke Spasticity']","['botulinum toxin therapy', 'Botulinum toxin therapy', 'botulinum toxin therapy in combination with dynamic electric neurostimulation and basic therapy, including massage and therapeutic exercises; Group 2 -botulinum toxin therapy and basic therapy; Group 3 - dynamic electric neurostimulation and basic therapy; Group 4 - basic therapy only', 'botulinum toxin therapy and dynamic electrical neurostimulation', 'Dynamic Electrical Neurostimulation and Botulinum Toxin Therapy']","['amplitude of voluntary movements', 'spasticity']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0521307', 'cui_str': 'Neurostimulation procedure'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}]",96.0,0.0191548,"CONCLUSIONS


Botulinum toxin therapy and dynamic electrical neurostimulation contributed to a more significant decrease in spasticity in the proximal and distal parts of the paretic upper extremity.","[{'ForeName': 'Stanislav G', 'Initials': 'SG', 'LastName': 'Abramovich', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Irkutsk State Medical Academy of Postgraduate Education - Branch of the FGBOU DPO RMANPO of the Ministry of Health of Russia, 664049, 100 Yubileynyy Microdistrict, Irkutsk, Russian Federation. Electronic address: abramovich5456@uoel.uk.'}, {'ForeName': 'Viktor A', 'Initials': 'VA', 'LastName': 'Drobyshev', 'Affiliation': 'Department of Hospital Therapy and Medical Rehabilitation, Novosibirsk State Medical University, 630091, 52 Krasnyy Ave., Novosibirsk, Russian Federation.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Pyatova', 'Affiliation': 'City Center for the Rehabilitation of Patients with the Consequences of Cerebrovascular Accident, City Clinical Hospital No. 2, 630075, 21 Polzunov Str., Novosibirsk, Russian Federation.'}, {'ForeName': 'Alexei V', 'Initials': 'AV', 'LastName': 'Yumashev', 'Affiliation': 'Department of Prosthetic Dentistry, I.M. Sechenov First Moscow State Medical University (Sechenov University), 119991, 8-2 Trubetskaya Str., Moscow, Russian Federation.'}, {'ForeName': 'Elizaveta S', 'Initials': 'ES', 'LastName': 'Koneva', 'Affiliation': 'Department of Sports Medicine and Medical Rehabilitation, I.M. Sechenov First Moscow State Medical University (Sechenov University), 119991, 8-2 Trubetskaya Str., Moscow, Russian Federation.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105189']
1067,33066972,"The PREVENNT randomised, double-blind, controlled trial of preoperative intravenous iron to treat anaemia before major abdominal surgery: an independent discussion.","Anaemia is a common finding in patients presenting for major elective surgery and is associated with poor outcomes including death and complications. Iron deficiency is the leading cause of perioperative anaemia. Intravenous (i.v.) iron is considered to be an effective and safe treatment for iron deficiency anaemia and is recommended by expert opinion for treatment of preoperative anaemia, although evidence from clinical trials is lacking. The PREVENTT trial was a large multicentre trial investigating the effects of i.v. iron on red cell transfusion, death, complications and quality of life in 487 patients undergoing major abdominal surgery. The principal finding of this multicentre randomised placebo controlled trial was that there was no difference in the co-primary outcomes of blood transfusion or death, or the number of transfusion episodes, within 30 days after surgery, in patients that received preoperative i.v. iron therapy compared to placebo. The major inferential differences in this independent discussion relate to the limitations of the PREVENTT trial and its implications for future practice. Although PREVENTT represents the best evidence available to guide perioperative use of i.v. iron, it is likely that the study was underpowered. In the context of already widespread adoption of preoperative i.v. iron therapy, many clinicians may have felt they lacked equipoise. In light of the PREVENTT study routine use of i.v. iron in patients undergoing elective abdominal surgery cannot be recommended. Further research should define the optimum red cell transfusion strategy for patients undergoing surgery and idenify other surgical groups who may benefit from this intervention.",2020,"The principal finding of this multicentre randomised placebo controlled trial was that there was no difference in the co-primary outcomes of blood transfusion or death, or the number of transfusion episodes, within 30 days after surgery, in patients that received preoperative i.v.","['to treat anaemia before major abdominal surgery', '487 patients undergoing major abdominal surgery', 'patients undergoing surgery and idenify other surgical groups who may benefit from this intervention', 'patients undergoing elective abdominal surgery', 'patients presenting for major elective surgery']","['placebo', 'preoperative intravenous iron']","['blood transfusion or death, or the number of transfusion episodes', 'red cell transfusion, death, complications and quality of life']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",487.0,0.370634,"The principal finding of this multicentre randomised placebo controlled trial was that there was no difference in the co-primary outcomes of blood transfusion or death, or the number of transfusion episodes, within 30 days after surgery, in patients that received preoperative i.v.","[{'ForeName': 'Tom E F', 'Initials': 'TEF', 'LastName': 'Abbott', 'Affiliation': 'William Harvey Research Institute, Queen Mary University of London, London, UK. Electronic address: t.abbott@qmul.ac.uk.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gillies', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, Royal Infirmary of Edinburgh, Edinburgh, UK. Electronic address: Michael.Gillies@ed.ac.uk.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.08.053']
1068,33066973,Responsiveness and thresholds for clinically meaningful changes in worst pain numerical rating scale for dysmenorrhea and nonmenstrual pelvic pain in women with moderate to severe endometriosis.,"OBJECTIVE


To evaluate the utility, responsiveness, and thresholds for clinically meaningful change of a numerical rating scale for worst pain associated with dysmenorrhea (NRS-DYS) and nonmenstrual pelvic pain (NRS-NMPP) in women with moderate to severe endometriosis-associated pain.
DESIGN


Analysis of data from two phase III randomized clinical trials (EM-I [NCT01620528] and EM-II [NCT01931670]).
SETTING


Not applicable.
PATIENT(S)


Premenopausal women ages 18-49 years with moderate to severe endometriosis-associated pain.
INTERVENTION(S)


Participants in both trials were randomized 3:2:2 to receive placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily for 6 months.
MAIN OUTCOME MEASURE(S)


NRS-DYS and NRS-NMPP.
RESULT(S)


EM-I enrolled 871 women and EM-II enrolled 815 women. For patients with a global impression of improvement at month 3, the least-squares mean change between baseline and month 3 was -3.6 (EM-I and EM-II) for NRS-DYS and -1.9 (EM-I) and -2.0 (EM-II) for NRS-NMPP. Standard errors of measurement were 2.99 (EM-I) and 2.86 (EM-II) for NRS-DYS and 1.74 (EM-I) and 1.71 (EM-II) for NRS-NMPP. Baseline half standard deviations were 0.78 (EM-I) and 0.85 (EM-II) for NRS-DYS and 0.92 (EM-I) and 0.96 (EM-II) for NRS-NMPP. Based on these results, clinically meaningful changes were defined as a reduction of 4 points for NRS-DYS and 2 points for NRS-NMPP.
CONCLUSION(S)


This study demonstrated the utility and responsiveness of separate numerical rating scales to assess worst pain for dysmenorrhea and NMPP in women with moderate to severe endometriosis-associated pain and identified initial thresholds for clinically meaningful change.",2020,Standard errors of measurement were 2.99 (EM-I) and 2.86 (EM-II) for NRS-DYS and 1.74 (EM-I) and 1.71 (EM-II) for NRS-NMPP.,"['871 women and EM-II enrolled 815 women', 'women with moderate to severe endometriosis-associated pain and identified initial thresholds for clinically meaningful change', 'women with moderate to severe endometriosis-associated pain', '\n\n\nPremenopausal women ages 18-49 years with moderate to severe endometriosis-associated pain', 'women with moderate to severe endometriosis']","['nonmenstrual pelvic pain (NRS-NMPP', 'placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily for 6 months']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4704593', 'cui_str': 'elagolix 150 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4704604', 'cui_str': 'elagolix 200 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],871.0,0.0907509,Standard errors of measurement were 2.99 (EM-I) and 2.86 (EM-II) for NRS-DYS and 1.74 (EM-I) and 1.71 (EM-II) for NRS-NMPP.,"[{'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Pokrzywinski', 'Affiliation': 'Evidera, Bethesda, Maryland. Electronic address: robin.pokrzywinski@evidera.com.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Soliman', 'Affiliation': 'AbbVie, North Chicago, Illinois.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Snabes', 'Affiliation': 'AbbVie, North Chicago, Illinois.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Evidera, Bethesda, Maryland.'}, {'ForeName': 'Hugh S', 'Initials': 'HS', 'LastName': 'Taylor', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Coyne', 'Affiliation': 'Evidera, Bethesda, Maryland.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.07.013']
1069,33066974,Urinary selective serotonin reuptake inhibitors across critical windows of pregnancy establishment: a prospective cohort study of fecundability and pregnancy loss.,"OBJECTIVE


To prospectively investigate the association of selective serotonin reuptake inhibitor (SSRI) exposure through critical windows of pregnancy establishment with fecundability and pregnancy loss.
DESIGN


Prospective cohort study using longitudinal urine measurements of common SSRIs while women are actively trying to conceive.
SETTING


Four clinical sites.
PATIENT(S)


A total of 1,228 women without uncontrolled depression/anxiety, attempting natural conception while participating in a randomized trial of preconception-initiated low-dose aspirin.
INTERVENTIONS(S)


Not applicable.
MAIN OUTCOME MEASURE(S)


Urinary SSRIs (fluoxetine, sertraline, escitalopram/citalopram) were measured while trying to conceive and, for women who became pregnant, at weeks 0, 4, and 8 of pregnancy. Fecundability odds ratios and incidence of pregnancy loss and live birth were estimated.
RESULT(S)


A total of 172 women (14%) were exposed to SSRIs while trying to conceive. SSRI exposure was associated with 24% reduced fecundability, and accordingly, a nonsignificant 9% lower live birth incidence, with significantly lower live birth in fluoxetine-exposed women. SSRI exposure was not associated with subsequent pregnancy loss, whether exposure was before conception or at 0, 4, or 8 weeks of gestation, although estimates varied by specific SSRI drug.
CONCLUSION(S)


Women using SSRIs may have more difficulty becoming pregnant, and although SSRI exposure overall was not associated with pregnancy loss, fluoxetine deserves caution and future study.
CLINICAL TRIAL REGISTRATION NUMBER


NCT00467363.",2020,"SSRI exposure was associated with 24% reduced fecundability, and accordingly, a nonsignificant 9% lower live birth incidence, with significantly lower live birth in fluoxetine-exposed women.","['1,228 women without uncontrolled depression/anxiety, attempting natural conception while participating in a randomized trial of', '172 women (14%) were exposed to SSRIs while trying to conceive', 'Four clinical sites']","['fluoxetine', 'preconception-initiated low-dose aspirin', 'selective serotonin reuptake inhibitor (SSRI']","['SSRI exposure', 'live birth', 'Urinary SSRIs (fluoxetine, sertraline, escitalopram/citalopram', 'live birth incidence', 'Fecundability odds ratios and incidence of pregnancy loss and live birth']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0420843', 'cui_str': 'Trying to conceive'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}]","[{'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0156543', 'cui_str': 'Pregnancy with abortive outcome'}]",1228.0,0.0428474,"SSRI exposure was associated with 24% reduced fecundability, and accordingly, a nonsignificant 9% lower live birth incidence, with significantly lower live birth in fluoxetine-exposed women.","[{'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Sjaarda', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland. Electronic address: lindsey.sjaarda@nih.gov.'}, {'ForeName': 'Jeannie G', 'Initials': 'JG', 'LastName': 'Radoc', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Kerry S', 'Initials': 'KS', 'LastName': 'Flannagan', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Keewan', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah; Intermountain Healthcare, Salt Lake City, Utah.'}, {'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.06.037']
1070,33066980,[Efficacy of magnetotherapy in hand erosive osteoarthritis. A clinical trial].,"INTRODUCTION


Erosive arthritis is an unusual pathology. Despite using magnetotherapy as a treatment, there is no evidence supporting its use. The aim of the study is to evaluate magnetotherapy efficacy in patients suffering from hand erosive arthritis, compared to placebo, in terms of pain. Treatment safety will be also evaluated.
METHOD


Prospective experimental double-blind randomized study consisting of an intervention group (IG: treatment with magnetotherapy: 15 20-minute-sesions 5 consecutive days per week) and a control group (CG: placebo). Treatment efficacy was evaluated at the end and 3 months after. We used Visual Analog Scale (VAS) for assess pain. Secondarily, functionality (The Disabilities of the Arm, Shoulder and Hand (DASH) score), rigidity (Modified Kapandji Index), grip strength (dynamometry) and quality of life (SF-36 questionnaire) were assessed.
RESULTS


29 patients were evaluated. Due to exclusion criteria, there were 19 patients left, all women with an average age of 59. After randomization, 10 were awarded to IG and 9 to CG, being both comparable groups. A higher percentage of patients with pain controlled (VAS<6) was found in IG post treatment and after 3-months (77.8% vs 33.3%, p=0.1 y 83.3% vs 33.3%, p=0.2; respectively). A tendency to decrease VAS for IG at 3-months (regression coefficient: -2.1 (95% CI: -5.7-1.5; p=0.2) was showed. There were no other statistically significant differences, except a higher dynamometry results in IG, in both hands (p<0.01 and p<0.04 respectively). There were neither adverse effects nor secondary effects.
CONCLUSION


Magnetotherapy treatment for hand erosive arthritis patients is safe and probably leads to clinical improvement.",2020,"There were no other statistically significant differences, except a higher dynamometry results in IG, in both hands (p<0.01 and p<0.04 respectively).","['hand erosive osteoarthritis', '29 patients were evaluated', 'hand erosive arthritis patients', 'patients suffering from hand erosive arthritis', '19 patients left, all women with an average age of 59']","['intervention group (IG: treatment with magnetotherapy', 'magnetotherapy', 'placebo', 'Magnetotherapy', 'control group (CG: placebo']","['Secondarily, functionality (The Disabilities of the Arm, Shoulder and Hand (DASH) score), rigidity (Modified Kapandji Index), grip strength (dynamometry) and quality of life (SF-36 questionnaire', 'magnetotherapy efficacy', 'Visual Analog Scale (VAS) for assess pain', 'Treatment efficacy']","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0451840', 'cui_str': 'Erosive osteoarthrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4285959', 'cui_str': 'Erosive arthritis'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",29.0,0.116592,"There were no other statistically significant differences, except a higher dynamometry results in IG, in both hands (p<0.01 and p<0.04 respectively).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Boada-Pladellorens', 'Affiliation': 'Servicio de Medicina Física y Rehabilitación del Hospital Nostra Senyora de Meritxell, Andorra. Electronic address: annaboada@gmail.com.'}, {'ForeName': 'À', 'Initials': 'À', 'LastName': 'Jaén Manzanera', 'Affiliation': 'Fundació Docència i Recerca MútuaTerrassa. Hospital Universitari Mútua de Terrassa, Barcelona, España.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bertran Garcia', 'Affiliation': 'Servicio de Medicina Física y Rehabilitación, Hospital Universitari Dr.Josep Trueta, Girona, España.'}, {'ForeName': 'À', 'Initials': 'À', 'LastName': 'Abril Carreras', 'Affiliation': 'Servicio de Medicina Física y Rehabilitación, Hospital Universitari Mútua de Terrassa, Barcelona, España.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Salvador Alarcón', 'Affiliation': 'Servicio de Reumatología, Hospital Universitari Mútua de Terrassa, Barcelona, España.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Martínez Pardo', 'Affiliation': 'Servicio de Reumatología, Hospital Universitari Mútua de Terrassa, Barcelona, España.'}]",Rehabilitacion,['10.1016/j.rh.2020.06.001']
1071,33067118,Comparison Between Combination of Resonant Voice Therapy and Vocal Hygiene Education and Vocal Hygiene Education Only for Female Elementary School Teachers.,"OBJECTIVE


The study compares the rehabilitation outcome of two voice intervention methods for female elementary school teachers with self-reported voice disorders.
METHODS


A total of 34 female teachers from two primary schools volunteered in the study. Participants from one school were assigned to the experimental group (16 teachers), who received the combination of vocal hygiene education and resonant voice therapy. Participants from the other school were assigned to the control group (18 teachers), who received vocal hygiene education only. Pre- and post-treatment data were compared.
RESULT


The total score of the Voice Handicap Index (VHI) decreased significantly from 12.19 ± 8.58 to 8.63 ± 7.27 (P < 0.05); the functional score of VHI significantly decreased from 5.38 ± 3.9 to 3.81 ± 3.62 (P < 0.05). No statistical significance was found in physiological and emotional scores of VHI. No statistical significance was found in the control group. In the experimental group, the maximum phonation time was increased from 14.34 ± 6.80s to 17.21 ± 6.06s (P < 0.05), Jitter decreased from 0.45% ± 0.13% to 0.26% ± 0.05% (P < 0.05), and Shimmer decreased from 0.21 ± 0.10. to 0.12 ± 0.03 (P < 0.05). Furthermore, the harmonic to noise ratio increased from 23.06 ± 2.99 to 25.23 ± 1.92 (P < 0.05), Spectrum Convergence Ratio increased from 0.53 ± 0.12 to 0.60 ± 0.11 (P < 0.05), yet no statistical significance was found in Nonlinear Energy Difference Ratio data for the experimental group. No statistical significance was found in the control group. In the auditory perception assessment (GRBAS), the G score decreased from 1.19 ± 0.54 to 0.81 ± 0.40 (P < 0.05), and the R score decreased from 1.19 ± 0.54 to 0.75 ± 0.45 (P < 0.05) in the experimental group. No statistical significance was found in the B, A, and S scores in the experimental group; moreover, none of the GRBAS scores in the control group demonstrated statistical significance. In the voice type component profile (VTC), the proportion of VTC1 of the experimental group increased significantly, while the proportions of VTC3 and VTC4 decreased significantly, indicating the improvement of voice quality was obvious after the intervention. The proportions of VTC of the control group did not demonstrate significant change.
CONCLUSION


The results of this study show that a combination of vocal hygiene education and resonant voice therapy can significantly improve the voice function of professional voice users and effectively improve their voice quality. In this study, the professional voice users receiving vocal hygiene education only did not show significant improvement of their voice quality.",2020,"In the voice type component profile (VTC), the proportion of VTC1 of the experimental group increased significantly, while the proportions of VTC3 and VTC4 decreased significantly, indicating the improvement of voice quality was obvious after the intervention.","['female elementary school teachers with self-reported voice disorders', 'Female Elementary School Teachers', 'Participants from one school', '34 female teachers from two primary schools volunteered in the study']","['vocal hygiene education only', 'voice intervention methods', 'vocal hygiene education and resonant voice therapy', 'Resonant Voice Therapy and Vocal Hygiene Education and Vocal Hygiene Education']","['Jitter', 'auditory perception assessment (GRBAS), the G score', 'maximum phonation time', 'total score of the Voice Handicap Index (VHI', 'proportions of VTC3 and VTC4', 'voice quality', 'physiological and emotional scores of VHI', 'GRBAS scores', 'functional score of VHI', 'harmonic to noise ratio', 'Spectrum Convergence Ratio', 'voice function of professional voice users and effectively improve their voice quality']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870482', 'cui_str': 'Elementary School Teachers'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0042940', 'cui_str': 'Voice Disorders'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0204945', 'cui_str': 'Hygiene education'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0577554', 'cui_str': 'Resonant'}, {'cui': 'C2202690', 'cui_str': 'Voice therapy'}]","[{'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234778', 'cui_str': 'Maximum phonation time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0443193', 'cui_str': 'Convergence'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",34.0,0.0160247,"In the voice type component profile (VTC), the proportion of VTC1 of the experimental group increased significantly, while the proportions of VTC3 and VTC4 decreased significantly, indicating the improvement of voice quality was obvious after the intervention.","[{'ForeName': 'Hengxin', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Minzu University of China, Beijing, China.'}, {'ForeName': 'ShengHwa', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Asia University.'}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Beijing Language and Culture University.'}, {'ForeName': 'Jinrang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The Sixth Medical Center of PLA General Hospital.'}, {'ForeName': 'Boquan', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Shanghai Jiao Tong University; University of Wisconsin-Madison.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Raj', 'Affiliation': 'University of Wisconsin-Madison.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': 'Beijing Language and Culture University.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Duan', 'Affiliation': 'Minzu University of China, Beijing, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Central Conservatory of Music.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The Sixth Medical Center of PLA General Hospital.'}, {'ForeName': 'Bangqi', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'CHEN Speech-Language Training Studio.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Minzu University of China, Beijing, China. Electronic address: 804934531@qq.com.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'University of Wisconsin-Madison.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2020.09.028']
1072,33067121,Mobile health technology-supported atrial fibrillation screening and integrated care: A report from the mAFA-II trial Long-term Extension Cohort.,"BACKGROUND


In the mobile Atrial Fibrillation App (mAFA)-II trial, the use of mobile health (mHealth) technology, incorporating AF screening and integrated management strategy, was associated with improved short-term clinical outcomes. The aim of this study was to report adherence/persistence and long term (≥1 year) clinical outcomes of the mAFA-II trial, with mHealth-supported optimised stroke prevention, symptom control and comorbidity management.
METHODS


We studied an adult population screened for AF, where identified patients could enter a structured program of holistic and integrated care based on the ABC (Atrial fibrillation Better Care) pathway using mHealth with a mAFA intervention. In this cluster randomised trial, comparing mHeath intervention to usual care, the primary composite outcome was 'stroke/thromboembolism, all-cause death and rehospitalization'.
RESULTS


The 1261 subjects (mean age 67.0 years, 38.0% female) who were followed up over one year (mean follow-up 687 (standard deviation, SD 191) days) in the intervention arm, had a lower risk of the composite outcome of 'ischaemic stroke/systemic thromboembolism, death, and rehospitalization' (hazard ratio, HR 0.18, 95% confidence interval, CI: 0.13-0.25, P < 0.001), compared to usual care (1212 subjects, mean age 70.1 years, 42.1% female). Of 842 patients using their smart devices for 'Better symptom management', 70.8% had good management adherence (monitoring time/follow-up since initial monitoring ≥ 70%), with the persistence of use of 91.7%.
CONCLUSION


Amongst AF patients with long term use (≥1 year) of mHealth technology for optimising stroke prevention, symptom control and comorbidity management, adherence/persistence was good and associated with a reduction in adverse clinical outcomes.",2020,"Amongst AF patients with long term use (≥1 year) of mHealth technology for optimising stroke prevention, symptom control and comorbidity management, adherence/persistence was good and associated with a reduction in adverse clinical outcomes.","[""842 patients using their smart devices for 'Better symptom management', 70.8% had"", '1261 subjects (mean age 67.0 years, 38.0% female', 'hazard ratio, HR 0.18, 95% confidence interval, CI: 0.13-0.25, P < 0.001), compared to usual care (1212 subjects, mean age 70.1 years, 42.1% female', 'adult population screened for AF, where identified patients could enter a structured program of holistic and integrated care based on the ABC (Atrial fibrillation Better Care) pathway using mHealth with a mAFA intervention']",['Mobile health technology-supported atrial fibrillation screening and integrated care'],"['stroke/thromboembolism, all-cause death and rehospitalization', 'good management adherence', ""lower risk of the composite outcome of 'ischaemic stroke/systemic thromboembolism, death, and rehospitalization""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4517433', 'cui_str': '0.18'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C4517428', 'cui_str': '0.13'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C4517385', 'cui_str': '0.001'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]",,0.11083,"Amongst AF patients with long term use (≥1 year) of mHealth technology for optimising stroke prevention, symptom control and comorbidity management, adherence/persistence was good and associated with a reduction in adverse clinical outcomes.","[{'ForeName': 'Yutao', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China; Liverpool Centre for Cardiovascular Sciences, University of Liverpool, Liverpool, United Kingdom; and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address: dor_guoyt@hotmail.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Xiangmin', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Institute for Hospital Management Research, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yundai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China; Liverpool Centre for Cardiovascular Sciences, University of Liverpool, Liverpool, United Kingdom; and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address: gregory.lip@liverpool.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of internal medicine,['10.1016/j.ejim.2020.09.024']
1073,33067129,A Novel Fortified Dairy Product and Sarcopenia Measures in Sarcopenic Older Adults: A Double-Blind Randomized Controlled Trial.,"OBJECTIVES


To evaluate the efficacy of daily consumption of fortified yogurt with beta-Hydroxy beta-Methyl Butyrate (HMB) and vitamins D and C on measures of sarcopenia, inflammation, and quality of life in sarcopenic older adults.
DESIGN


In this 12-week randomized double-blind controlled trial, participants received either yogurt fortified with 3 g HMB, 1000 IU vitamin D, and 500 mg vitamin C in the intervention group (n = 33) or plain yogurt in the control group (n = 33).
SETTING AND PARTICIPANTS


A total of 66 older adults with sarcopenia recruited from the community in Shiraz, Iran.
MEASURES


Body composition, muscle strength, and functionality were measured using Dual-energy-X-ray Absorptiometry (DXA), hydraulic handgrip dynamometer, and usual gait speed, respectively. Serum concentrations of vitamin D, insulin-like growth factor-1 (IGF-1), C-reactive protein (hs-CRP), malondialdehyde, and insulin were measured at baseline and after 12 weeks. Health-related quality of life (HRQoL) was also evaluated using SF-12 questionnaire.
RESULTS


Consumption of fortified yogurt was associated with improvement in handgrip strength [mean change (95% confidence interval) 4.36 (3.35-5.37) vs. 0.97 (-0.04 to 1.99)] and gait speed [0.10 (0.07-0.13) vs. 0.01 (0.00-0.04)] in the intervention group compared with the control group (P < .001). In addition, the results revealed a significant increase in vitamin D and IGF-1 levels in the intervention group (P < .001). The nutritional intervention significantly prevented any increase in the serum concentration of hs-CRP compared with the control group (P = .033). The results also showed a more significant decrease in the malondialdehyde level in the intervention group compared with the control (P = .008). Moreover, there were significant differences between the 2 groups regarding physical aspects of HRQoL (P = .035).
CONCLUSIONS AND IMPLICATIONS


A novel dairy product fortified with HMB, vitamin D, and vitamin C not only could enhance muscle strength and functionality, but also modulate anabolic and inflammatory conditions as well as quality of life. This study suggested that specific nutritional interventions alone could be beneficial, especially for those who are unable to exercise.",2020,The results also showed a more significant decrease in the malondialdehyde level in the intervention group compared with the control (P = .008).,"['Sarcopenic Older Adults', 'A total of 66 older adults with sarcopenia recruited from the community in Shiraz, Iran', 'sarcopenic older adults']","['HMB, vitamin D, and vitamin C', 'fortified yogurt with beta-Hydroxy beta-Methyl Butyrate (HMB) and vitamins D and C', 'Fortified Dairy Product and Sarcopenia Measures', 'yogurt fortified with 3\xa0g HMB, 1000 IU vitamin D, and 500\xa0mg vitamin C']","['Body composition, muscle strength, and functionality were measured using Dual-energy-X-ray Absorptiometry (DXA), hydraulic handgrip dynamometer, and usual gait speed, respectively', 'Health-related quality of life (HRQoL', 'serum concentration of hs-CRP', 'malondialdehyde level', 'handgrip strength', 'physical aspects of HRQoL', 'vitamin D and IGF-1 levels', 'gait speed', 'Serum concentrations of vitamin D, insulin-like growth factor-1 (IGF-1), C-reactive protein (hs-CRP), malondialdehyde, and insulin', 'sarcopenia, inflammation, and quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0066231', 'cui_str': 'Methyl butyrate'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0010947', 'cui_str': 'Dairy foods'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",66.0,0.268904,The results also showed a more significant decrease in the malondialdehyde level in the intervention group compared with the control (P = .008).,"[{'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Nasimi', 'Affiliation': 'Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Sohrabi', 'Affiliation': 'Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: zahra_2043@yahoo.com.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Dabbaghmanesh', 'Affiliation': 'Shiraz Endocrinology and Metabolism Research Center, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: dabbaghm@sums.ac.ir.'}, {'ForeName': 'Mohammad Hadi', 'Initials': 'MH', 'LastName': 'Eskandari', 'Affiliation': 'Department of Food Science and Technology, School of Agriculture, Shiraz University, Shiraz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Bedeltavana', 'Affiliation': 'Dairy Expert at Research and Development of Zarrin Ghazal Company (DAITY), Shiraz, Iran.'}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Famouri', 'Affiliation': 'Dairy Expert at Research and Development of Zarrin Ghazal Company (DAITY), Shiraz, Iran.'}, {'ForeName': 'Pedram', 'Initials': 'P', 'LastName': 'Talezadeh', 'Affiliation': 'Shiraz Endocrinology and Metabolism Research Center, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.08.035']
1074,33067169,"Effect of N-acetylcysteine on remission maintenance in patients with ulcerative colitis: A randomized, double-blind controlled clinical trial.","BACKGROUND


The use of antioxidant agents is suggested as a complementary therapy in UC patients for the prevention of flares. Considering the potent antioxidant activity of N-acetylcysteine (NAC), in the present study we aimed to assess the effect of this supplement on remission maintenance in patients with ulcerative colitis (UC).
METHODS


In the present double-blind randomized controlled clinical trial, 168 volunteer UC patients who were on high dose corticosteroid and Mesalamine for flare-up management, were recruited. The patients received 800 mg NAC or placebo for 16 weeks. Simultaneously, the prednisolone dose was tapered. The patients were followed up six more weeks post-intervention. The primary efficacy of the treatment was remaining in remission. The secondary outcomes were the endoscopic relapse, serum level of hs-CRP, hemoglobin, and fecal calprotectin level.
RESULTS


During 22 weeks follow up, 25 patients experienced relapses, six of them were in the NAC group and 19 of them were in the placebo group. There was a significant difference between the NAC and placebo groups regarding the relapse-free period (P = 0.007). Compared with the NAC group, significantly more patients in the placebo group had an endoscopic relapse (p < 0.001). At the end of the intervention period (16 weeks) and 6 weeks post-intervention, the mean fecal calprotectin, serum erythrocyte sedimentation rate, and hs-CRP levels were significantly lower in the NAC group compared with the placebo group (p < 0.05).
CONCLUSION


The findings indicated that NAC had a significantly more positive effect on the maintenance of remission compared with placebo in UC patients that were in the steroid-tapering phase of therapy.",2020,"Compared with the NAC group, significantly more patients in the placebo group had an endoscopic relapse (p < 0.001).","['168 volunteer UC patients who were on high dose', 'patients with ulcerative colitis (UC', 'for flare-up management, were recruited', 'UC patients', 'patients with ulcerative colitis']","['corticosteroid and Mesalamine', 'placebo', 'NAC', 'prednisolone', '800\u202fmg NAC or placebo', 'N-acetylcysteine', 'N-acetylcysteine (NAC']","['mean fecal calprotectin, serum erythrocyte sedimentation rate, and hs-CRP levels', 'endoscopic relapse', 'remission maintenance', 'endoscopic relapse, serum level of hs-CRP, hemoglobin, and fecal calprotectin level', 'maintenance of remission']","[{'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C3844106', 'cui_str': '800'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",168.0,0.580065,"Compared with the NAC group, significantly more patients in the placebo group had an endoscopic relapse (p < 0.001).","[{'ForeName': 'Kourosh', 'Initials': 'K', 'LastName': 'Masnadi Shirazi', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Sotoudeh', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Masnadi Shirazi', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Seyyed-Yaghoub', 'Initials': 'SY', 'LastName': 'Moaddab', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Nourpanah', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Nikniaz', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: znikniaz@hotmail.com.'}]",Clinics and research in hepatology and gastroenterology,['10.1016/j.clinre.2020.08.010']
1075,33067278,Effect of 12-week pulmonary rehabilitation on cognitive function in patients with stable chronic obstructive pulmonary disease: study protocol for a single-center randomised controlled trial.,"INTRODUCTION


Cognitive impairment, an important complication in patients with chronic obstructive pulmonary disease (COPD), seriously affects self-management of the disease and quality of life (QoL). As an exercise-based intervention programme, pulmonary rehabilitation (PR)-especially aerobic exercise (mainly mind-body exercise) and resistance exercise (RE)-has been proposed for its potential effectiveness in improving cognitive function. However, there is still a lack of strong evidence for PR's effectiveness. In this study, we expect to clarify the effects of pulmonary-based Qigong exercise and elastic band-based RE on cognitive function in patients with COPD and to fill in the relevant evidence blanks.
METHODS AND ANALYSIS


This study is a single-centre randomised controlled trial with assessor and data analyst blinding. We will recruit 108 participants with stable COPD starting on 23 December 2019, and randomly allocate them into the pulmonary-based Qigong exercise group, elastic band-based RE group, pulmonary-based Qigong exercise and elastic band-based RE combined group, or control group at a 1:1:1:1 ratio. Participants in intervention groups will perform 30 min of exercise two times per day, 5 days a week, for 12 weeks. The primary outcome will be the global cognitive function as assessed by the Montreal Cognitive Assessment and auditory event-related potential P300. Secondary outcomes will include the specific cognitive domains-attention, memory, executive function, verbal fluency and mental-processing speed; psychological functions and QoL. Exploratory outcomes will include grey matter volume and levels of inflammatory mediators. Outcomes will be measured before and after the interventions.
ETHICS AND DISSEMINATION


Ethics approval has been granted by the Ethics Committee of Yue-Yang Integrative Medicine Hospital, an affiliate of Shanghai University of Traditional Chinese Medicine, Shanghai, China (Grant No. 2019-141). Written informed consent will be obtained from each participant before any procedures are performed. The findings will be published in peer-reviewed journals and presented at academic conferences.
TRIAL REGISTRATION NUMBER


ChiCTR1900026869; pre-results.",2020,"Secondary outcomes will include the specific cognitive domains-attention, memory, executive function, verbal fluency and mental-processing speed; psychological functions and QoL. Exploratory outcomes will include grey matter volume and levels of inflammatory mediators.","['108 participants with stable COPD starting on 23 December 2019', 'patients with stable chronic obstructive pulmonary disease', 'patients with COPD and to fill in the relevant evidence blanks', 'patients with chronic obstructive pulmonary disease (COPD']","['pulmonary-based Qigong exercise and elastic band-based RE', 'pulmonary-based Qigong exercise group, elastic band-based RE group, pulmonary-based Qigong exercise and elastic band-based RE combined group, or control group', 'pulmonary rehabilitation', 'exercise-based intervention programme, pulmonary rehabilitation (PR)-especially aerobic exercise (mainly mind-body exercise) and resistance exercise (RE)-has']","['specific cognitive domains-attention, memory, executive function, verbal fluency and mental-processing speed; psychological functions and QoL. Exploratory outcomes will include grey matter volume and levels of inflammatory mediators', 'global cognitive function as assessed by the Montreal Cognitive Assessment and auditory event-related potential P300', 'cognitive function']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0233398', 'cui_str': 'Psychological function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}]",108.0,0.121401,"Secondary outcomes will include the specific cognitive domains-attention, memory, executive function, verbal fluency and mental-processing speed; psychological functions and QoL. Exploratory outcomes will include grey matter volume and levels of inflammatory mediators.","[{'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Duan', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Peijun', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Zhenwei', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, Shanghai University of Traditional Chinese Medicine Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai, China.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Weibing', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, Shanghai, China hzhp403@126.com.'}]",BMJ open,['10.1136/bmjopen-2020-037307']
1076,33067279,Effects of sulforaphane on cognitive function in patients with frontal brain damage: study protocol for a randomised controlled trial.,"INTRODUCTION


Many patients with frontal brain damage show serious cognitive function deficits, which hamper their quality of life and result in poor clinical outcomes. Preclinical research has shown that sulforaphane can significantly improve spatial localisation and working memory impairment after brain injury. The primary aim of this double-blind randomised controlled clinical trial is to assess the efficacy of sulforaphane for improving cognitive function in patients with frontal brain damage.
METHODS AND ANALYSIS


Ninety eligible patients will be randomly allocated to an active treatment or a placebo group in a 2:1 ratio. Participants will undergo a series of cognitive and neuropsychiatric tests at baseline (week 0) and after 12 weeks to determine the effect of sulforaphane on cognition. Magnetic resonance spectrum of the brain will be studied using the 3T MRIs of the brain to detect brain metabolites markers, including N-acetyl aspartate, glutamate (Glu), glutathione (GSH) and γ-aminobutyric acid (GABA). Blood brain-derived neurotrophic factor, Glu, GSH and GABA levels and gut microbiota will also be assessed over this period. This study will also evaluate long-term outcomes of brain trauma, brain tumours and cerebrovascular disease via exploratory analyses. The primary outcome will be the difference in scores of a battery of cognitive tests after 12 weeks of sulforaphane treatment. The secondary outcomes will be changes in the Functional Activities Questionnaire (FAQ), the Patient Health Questionnaire (PHQ-9), the Self-Rating Anxiety Scale, the changes in T1-weighted MRI and resting-state functional MRI findings, and changes in brain and blood metabolic markers and gut microbiota at weeks 0 and 12. We expect that sulforaphane will yield favourable results in treating memory and learning deficits for patients with frontal brain damage. Cognitive functional treatment may also improve brain trauma, brain tumours and cerebrovascular outcomes.
ETHICS AND DISSEMINATION


The study protocol has been approved by the Medical Ethics committee of the Xiangya Hospital of Central South University (No. 2017121019). The results will be disseminated in peer-reviewed journals and at international conferences.
TRIAL REGISTRATION NUMBER


This trial was registered on Clinicaltrials.gov on 31 January 2020 (NCT04252261). The protocol version is V.1.0 (20 December 2019).",2020,The primary outcome will be the difference in scores of a battery of cognitive tests after 12 weeks of sulforaphane treatment.,"['Xiangya Hospital of Central South University', 'patients with frontal brain damage', 'Ninety eligible patients']","['placebo', 'sulforaphane']","['Blood brain-derived neurotrophic factor, Glu, GSH and GABA levels and gut microbiota', 'N-acetyl aspartate, glutamate (Glu), glutathione (GSH) and γ-aminobutyric acid (GABA', 'scores of a battery of cognitive tests', 'cognitive function', 'brain trauma, brain tumours and cerebrovascular outcomes', 'Functional Activities Questionnaire (FAQ), the Patient Health Questionnaire (PHQ-9), the Self-Rating Anxiety Scale, the changes in T1-weighted MRI and resting-state functional MRI findings, and changes in brain and blood metabolic markers and gut microbiota']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0163159', 'cui_str': 'sulforafan'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}]",90.0,0.269977,The primary outcome will be the difference in scores of a battery of cognitive tests after 12 weeks of sulforaphane treatment.,"[{'ForeName': 'Fangkun', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Neurosurgery, Central South University (CSU), 410008, Changsha, Hunan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, the Second Xiangya Hospital, Central South University, 410011, Changsha, Hunan, China; Mental Health Institute of the Second Xiangya Hospital, Central South University, Chinese National Clinical Research Center on Mental Disorders (Xiangya), Chinese National Technology Institute on Mental Disorders, Hunan Key Laboratory of Psychiatry and Mental Health, 410011, Changsha, Hunan, China.'}, {'ForeName': 'Gangrui', 'Initials': 'G', 'LastName': 'Hei', 'Affiliation': 'Department of Psychiatry, the Second Xiangya Hospital, Central South University, 410011, Changsha, Hunan, China; Mental Health Institute of the Second Xiangya Hospital, Central South University, Chinese National Clinical Research Center on Mental Disorders (Xiangya), Chinese National Technology Institute on Mental Disorders, Hunan Key Laboratory of Psychiatry and Mental Health, 410011, Changsha, Hunan, China.'}, {'ForeName': 'Renrong', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, the Second Xiangya Hospital, Central South University, 410011, Changsha, Hunan, China; Mental Health Institute of the Second Xiangya Hospital, Central South University, Chinese National Clinical Research Center on Mental Disorders (Xiangya), Chinese National Technology Institute on Mental Disorders, Hunan Key Laboratory of Psychiatry and Mental Health, 410011, Changsha, Hunan, China zhixiongliu@csu.edu.cn wurenrong@csu.edu.cn.'}, {'ForeName': 'Zhixiong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Neurosurgery, Central South University (CSU), 410008, Changsha, Hunan, China zhixiongliu@csu.edu.cn wurenrong@csu.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2020-037543']
1077,33067294,Uptake and effectiveness of a tailor-made online lifestyle programme targeting modifiable risk factors for dementia among middle-aged descendants of people with recently diagnosed dementia: study protocol of a cluster randomised controlled trial (Demin study).,"INTRODUCTION


Descendants of patients with dementia have a higher risk to develop dementia. This study aims to investigate the uptake and effectiveness of an online tailor-made lifestyle programme for dementia risk reduction (DRR) among middle-aged descendants of people with recently diagnosed late-onset dementia.
METHODS AND ANALYSIS


Demin is a cluster randomised controlled trial, aiming to include 21 memory clinics of which 13 will be randomly allocated to the passive (poster and flyer in a waiting room) and 8 to the active recruitment strategy (additional personal invitation by members of the team of the memory clinic). We aim to recruit 378 participants (40-60 years) with a parent who is recently diagnosed with Alzheimer's disease or vascular dementia at one of the participating memory clinics. All participants receive a dementia risk assessment (online questionnaire, physical examination and blood sample) and subsequently an online tailor-made lifestyle advice regarding protective (Mediterranean diet, low/moderate alcohol consumption and high cognitive activity) and risk factors (physical inactivity, smoking, loneliness, cardiovascular diseases (CVD), hypertension, high cholesterol, diabetes, obesity, renal dysfunction and depression) for dementia. The primary outcome is the difference in uptake between the two recruitment strategies. Secondary outcomes are change(s) in (1) the Lifestyle for Brain Health score, (2) individual health behaviours, (3) health beliefs and attitudes towards DRR and (4) compliance to the tailor-made lifestyle advice. Outcomes will be measured at 3, 6, 9 and 12 months after baseline. The effectiveness of this online tailor-made lifestyle programme will be evaluated by comparing Demin participants to a matched control group (lifelines cohort).
ETHICS AND DISSEMINATION


This study has been approved by the Dutch Ministry of Health, Welfare and Sport according to the Population Screening Act. All participants have to give online informed consent using SMS-tan (transaction authentication number delivered via text message). Findings will be disseminated through peer-reviewed journals and (inter)national conferences.
TRIAL REGISTRATION NUMBER


NTR7434.",2020,"The effectiveness of this online tailor-made lifestyle programme will be evaluated by comparing Demin participants to a matched control group (lifelines cohort).
","['dementia risk reduction (DRR) among middle-aged descendants of people with recently diagnosed late-onset dementia', 'Demin participants to a matched control group (lifelines cohort', 'dementia among middle-aged descendants of people with recently diagnosed dementia', 'patients with dementia have a higher risk to develop dementia', ""378 participants (40-60 years) with a parent who is recently diagnosed with Alzheimer's disease or vascular dementia at one of the participating memory clinics"", '21 memory clinics of which 13 will be randomly allocated to the']","['tailor-made online lifestyle programme', 'dementia risk assessment (online questionnaire, physical examination and blood sample) and subsequently an online tailor-made lifestyle advice regarding protective (Mediterranean diet, low/moderate alcohol consumption and high cognitive activity', 'passive (poster and flyer in a waiting room) and 8 to the active recruitment strategy (additional personal invitation by members of the team of the memory clinic', 'online tailor-made lifestyle programme']","['Uptake and effectiveness', 'change(s) in (1) the Lifestyle for Brain Health score, (2) individual health behaviours, (3) health beliefs and attitudes towards DRR and (4) compliance to the tailor-made lifestyle advice', 'risk factors (physical inactivity, smoking, loneliness, cardiovascular diseases (CVD), hypertension, high cholesterol, diabetes, obesity, renal dysfunction and depression']","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0011269', 'cui_str': 'Vascular dementia'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0814098', 'cui_str': 'Health belief'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",378.0,0.198922,"The effectiveness of this online tailor-made lifestyle programme will be evaluated by comparing Demin participants to a matched control group (lifelines cohort).
","[{'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Vrijsen', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands j.vrijsen@umcg.nl.'}, {'ForeName': 'Ameen', 'Initials': 'A', 'LastName': 'Abu-Hanna', 'Affiliation': 'Department of Medical Informatics, University of Amsterdam, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Els Lm', 'Initials': 'EL', 'LastName': 'Maeckelberghe', 'Affiliation': 'Wenckebach Institute for Training and Education, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Peter Paul', 'Initials': 'PP', 'LastName': 'De Deyn', 'Affiliation': 'Department of Neurology and Alzheimer Centre Groningen, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Andrea F', 'Initials': 'AF', 'LastName': 'de Winter', 'Affiliation': 'Department of Health Sciences, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Fransje E', 'Initials': 'FE', 'LastName': 'Reesink', 'Affiliation': 'Department of Neurology and Alzheimer Centre Groningen, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Oude Voshaar', 'Affiliation': 'Department of Psychiatry, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Buskens', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sophia E', 'Initials': 'SE', 'LastName': 'de Rooij', 'Affiliation': 'Medical School Twente, Medical Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Nynke', 'Initials': 'N', 'LastName': 'Smidt', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-039439']
1078,33067295,Internet-based patient- primary care physician-cardiologist integrated management model of hypertension in China: study protocol for a multicentre randomised controlled trial.,"INTRODUCTION


The control rate of hypertension is low in China, especially in rural, western and minority areas. This is related to poor medical skills among physicians in primary care institutions and low levels of trust among patients. However, primary healthcare institutions are the main battleground for the prevention and treatment of hypertension. It is worth exploring how to most effectively integrate patients, primary care physicians and cardiologists in tertiary hospitals, to build a long-term mechanism for the prevention and treatment of hypertension. In this study, we aim to evaluate the clinical effectiveness and conduct a health economic evaluation of an internet-based patient-primary care physician-cardiologist integrated management model of hypertension in areas of China with different socioeconomic levels.
METHODS AND ANALYSIS


This is a 12-month, multicentre, randomised controlled trial involving patients with hypertension in urban communities and rural areas of Sichuan Province, China. Each primary healthcare institution will cooperate with their tertiary hospital through the Red Shine Chronic Disease Management System (RSCDMS). Patients will be randomly assigned 1:1 to two groups: (1) a traditional care group; (2) an intervention group in which primary care physicians and cardiologists can share patient data and manage patients together through the RSCDMS. Patients can upload their blood pressure (BP) values and communicate with physicians using the system. The primary outcome is the change in systolic BP over a 12-month period. Secondary outcomes are changes in diastolic BP, BP control rate, values of 24-hour ambulatory BP monitoring, difference in cost-effectiveness between the groups, patient satisfaction, medication adherence and home BP monitoring compliance. All data will be recorded and stored in the RSCDMS and analysed using IBM SPSS V.26.0.
ETHICS AND DISSEMINATION


This study has been approved by the Biomedical Research Ethics Committee of the West China Hospital of Sichuan University in Sichuan, China (No. 2020-148). Written informed consent will be obtained from all participants. The results of this study will be disseminated to the public through academic conferences and peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ChiCTR2000030677.",2020,Each primary healthcare institution will cooperate with their tertiary hospital through the Red Shine Chronic Disease Management System (RSCDMS).,"['hypertension in China', 'patients with hypertension in urban communities and rural areas of Sichuan Province, China', 'West China Hospital of Sichuan University in Sichuan, China (No. 2020-148', 'hypertension in areas of China with different socioeconomic levels']","['traditional care group; (2) an intervention group in which primary care physicians and cardiologists can share patient data and manage patients together through the RSCDMS', 'internet-based patient-primary care physician-cardiologist integrated management model', 'Internet-based patient- primary care physician-cardiologist integrated management model']","['changes in diastolic BP, BP control rate, values of 24-hour ambulatory BP monitoring, difference in cost-effectiveness between the groups, patient satisfaction, medication adherence and home BP monitoring compliance', 'change in systolic BP', 'blood pressure (BP) values']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0175906', 'cui_str': 'Cardiologist'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0005825', 'cui_str': 'Sphygmomanometers, Continuous'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.0735516,Each primary healthcare institution will cooperate with their tertiary hospital through the Red Shine Chronic Disease Management System (RSCDMS).,"[{'ForeName': 'Runyu', 'Initials': 'R', 'LastName': 'Ye', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Rufeng', 'Initials': 'R', 'LastName': 'Shi', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Liao', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Xinran', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Qiling', 'Initials': 'Q', 'LastName': 'Gou', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Rong', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Zhipeng', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Changqiang', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China xiaopingchen15@126.com.'}]",BMJ open,['10.1136/bmjopen-2020-039447']
1079,33067298,Protocol for a definitive randomised controlled trial and economic evaluation of a community-based rehabilitation programme following hip fracture: fracture in the elderly multidisciplinary rehabilitation-phase III (FEMuR III).,"INTRODUCTION


Proximal femoral (hip) fracture is common, serious and costly. Rehabilitation may improve functional recovery but evidence of effectiveness and cost-effectiveness are lacking. An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT). The objectives are to compare the effectiveness and cost-effectiveness of the enhanced rehabilitation programme following surgical repair of proximal femoral fracture in older people compared with usual care.
METHODS AND ANALYSIS


Protocol for phase III, parallel-group, two-armed, superiority, pragmatic RCT with 1:1 allocation ratio; allocation sequence by minimisation programme with a built-in random element; secure web-based allocation concealment. The two treatments will be usual care (control) and usual care plus an enhanced rehabilitation programme (intervention). The enhanced rehabilitation will consist of a patient-held information workbook, goal setting diary and up to six additional therapy sessions. Outcome assessment and statistical analysis will be performed blind; patient and carer participants will be unblinded. Outcomes will be measured at baseline, 17 and 52 weeks' follow-up. Primary outcome at 52 weeks will be the Nottingham Extended Activities of Daily Living scale. Secondary outcomes will measure anxiety and depression, health utility, cognitive status, hip pain intensity, falls self-efficacy, fear of falling, grip strength and physical function. Carer strain, anxiety and depression will be measured in carers. All safety events will be recorded, and serious adverse events will be assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be a cost-utility analysis from a health service and personal social care perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the enhanced rehabilitation programme.
ETHICS AND DISSEMINATION


National Health Service research ethics approval reference 18/NE/0300. Results will be disseminated by peer-reviewed publication.
TRIAL REGISTRATION NUMBER


ISRCTN28376407; Pre-results registered on 23 November 2018.",2020,An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT).,"['older people compared with usual care', 'hip fracture: fracture in the elderly multidisciplinary rehabilitation-phase III (FEMuR III']","['pragmatic RCT with 1:1 allocation ratio; allocation sequence by minimisation programme with a built-in random element; secure web-based allocation concealment', 'enhanced rehabilitation programme', 'community-based rehabilitation programme', 'usual care (control) and usual care plus an enhanced rehabilitation programme (intervention']","['effectiveness and cost-effectiveness', 'Carer strain, anxiety and depression', 'anxiety and depression, health utility, cognitive status, hip pain intensity, falls self-efficacy, fear of falling, grip strength and physical function', 'Nottingham Extended Activities of Daily Living scale']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.127749,An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT).,"[{'ForeName': 'Nefyn', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Department of Primary Care and Mental Health, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK nefyn.williams@liverpool.ac.uk.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Hardwick', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Dannii', 'Initials': 'D', 'LastName': 'Clayton', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Rhiannon Tudor', 'Initials': 'RT', 'LastName': 'Edwards', 'Affiliation': 'Centre for Health Economics & Medicines Evaluation, Bangor University College of Human Sciences, Bangor, Gwynedd, UK.'}, {'ForeName': 'Joanna Mary', 'Initials': 'JM', 'LastName': 'Charles', 'Affiliation': 'Centre for Health Economics & Medicines Evaluation, Bangor University College of Human Sciences, Bangor, Gwynedd, UK.'}, {'ForeName': 'Phillipa', 'Initials': 'P', 'LastName': 'Logan', 'Affiliation': 'Division of Rehabilitation and Ageing, University of Nottingham Faculty of Medicine and Health Sciences, Nottingham, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Busse', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'North Wales Centre for Primary Care Research, Bangor University College of Human Sciences, Bangor, Gwynedd, UK.'}, {'ForeName': 'Toby O', 'Initials': 'TO', 'LastName': 'Smith', 'Affiliation': 'School of Health Sciences, University of East Anglia Faculty of Medicine and Health Sciences, Norwich, Norfolk, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sackley', 'Affiliation': 'University of Nottingham Faculty of Medicine and Health Sciences, Nottingham, UK.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Morrison', 'Affiliation': 'School of Psychology, Bangor University College of Human Sciences, Bangor, Gwynedd, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Lemmey', 'Affiliation': 'School of Sports, Health and Exercise Science, Bangor University College of Human Sciences, Bangor, Gwynedd, UK.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Masterson-Algar', 'Affiliation': 'School of Healthcare Sciences, Bangor University College of Human Sciences, Bangor, Gwynedd, UK.'}, {'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Howard', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Hennessy', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Soady', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Ralph', 'Affiliation': 'Department of Primary Care and Mental Health, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Dobson', 'Affiliation': 'Department of Primary Care and Mental Health, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Shanaz', 'Initials': 'S', 'LastName': 'Dorkenoo', 'Affiliation': 'Involving People Network, Health and Care Research Wales, Cardiff, UK.'}]",BMJ open,['10.1136/bmjopen-2020-039791']
1080,33067301,Effect of wheelchair-modified rowing exercise on cardiometabolic risk factors in spinal cord injured wheelchair users: protocol for a randomised controlled trial.,"INTRODUCTION


Cardiovascular and metabolic diseases are a growing concern for individuals with spinal cord injury (SCI). Physical inactivity contributes to cardiometabolic morbidity and mortality in the SCI population. However, previous studies have shown mixed results regarding the effects of exercise on cardiometabolic risk factors in individuals with SCI. This discrepancy could be influenced by insufficient exercise stimuli. Recent guidelines recommend 30 min of moderate-to-vigorous intensity aerobic exercise, three times per week, for improvement in cardiometabolic health in individuals with SCI. However, to date, no studies have implemented an exercise intervention matching the new recommendations to examine the effects on cardiometabolic risk factors. Therefore, the primary objective of this study is to determine the effects of 12 weeks of wheelchair user-modified upper-body rowing exercise on both traditional (constituents of the metabolic syndrome) and novel (eg, vascular structure and function) cardiometabolic risk factors in manual wheelchair users with SCI.
METHODS AND ANALYSIS


A randomised controlled trial will compare 12 weeks of upper-body rowing exercise, 30 min three times per week, with a control group continuing their normal lifestyle. Outcome measurements will be performed immediately before (baseline), after 6 weeks (halfway), 12 weeks of training (post) and 6 months after the termination of the intervention period (follow-up). Outcomes will include inflammatory (eg, C reactive protein) and metabolic biomarkers determined from venous blood (with serum fasting insulin as primary outcome), body composition, arterial blood pressure, cardiorespiratory fitness level, brachial artery vascular structure and function and autonomic nervous system function.
ETHICS AND DISSEMINATION


This trial is reported to the Danish Data Protection Agency (J.nr. 2019-899/10-0406) and approved by the Committees on Health Research Ethics in The North Denmark Region on 12 December 2019 (J.nr. N-20190053). The principal investigator will collect written informed consent from all participants prior to inclusion. Irrespective of study outcomes, the results will be submitted to peer-reviewed scientific journals for publication.
TRIAL REGISTRATION NUMBER


NCT04390087.",2020,"A randomised controlled trial will compare 12 weeks of upper-body rowing exercise, 30 min three times per week, with a control group continuing their normal lifestyle.","['individuals with SCI', 'manual wheelchair users with SCI', 'individuals with spinal cord injury (SCI', 'spinal cord injured wheelchair users']","['wheelchair user-modified upper-body rowing exercise', 'wheelchair-modified rowing exercise', 'upper-body rowing exercise']","['cardiometabolic risk factors', 'novel (eg, vascular structure and function) cardiometabolic risk factors', 'cardiometabolic health', 'inflammatory (eg, C reactive protein) and metabolic biomarkers determined from venous blood (with serum fasting insulin as primary outcome), body composition, arterial blood pressure, cardiorespiratory fitness level, brachial artery vascular structure and function and autonomic nervous system function', 'cardiometabolic morbidity and mortality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0184423', 'cui_str': 'Manual wheelchair'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0853966', 'cui_str': 'Wheelchair user'}]","[{'cui': 'C0853966', 'cui_str': 'Wheelchair user'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043143', 'cui_str': 'Wheelchair'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0234593', 'cui_str': 'Autonomic nervous system function'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0895916,"A randomised controlled trial will compare 12 weeks of upper-body rowing exercise, 30 min three times per week, with a control group continuing their normal lifestyle.","[{'ForeName': 'Rasmus Kopp', 'Initials': 'RK', 'LastName': 'Hansen', 'Affiliation': 'Sport Sciences - Performance and Technology, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark rkopp@hst.aau.dk.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Samani', 'Affiliation': 'Sport Sciences - Performance and Technology, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Uffe', 'Initials': 'U', 'LastName': 'Laessoe', 'Affiliation': 'Department of Research and Development, University College of Northern Jutland (UCN), Aalborg, Denmark.'}, {'ForeName': 'Aase', 'Initials': 'A', 'LastName': 'Handberg', 'Affiliation': 'Department of Clinical Biochemistry, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Ryan Godsk', 'Initials': 'RG', 'LastName': 'Larsen', 'Affiliation': 'Sport Sciences - Performance and Technology, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}]",BMJ open,['10.1136/bmjopen-2020-040727']
1081,33067310,Impact of oral corticosteroids on respiratory outcomes in acute preschool wheeze: a randomised clinical trial.,"OBJECTIVE


To determine if administration of oral prednisolone to preschool children with acute wheeze alters respiratory outcomes.
DESIGN


Double-blind, randomised, placebo-controlled equivalence trial.
SETTING


Three hospitals in New Zealand.
PATIENTS


477 children aged 24-59 months with acute wheeze associated with respiratory illness.
INTERVENTIONS


2 mg/kg (maximum 40 mg) oral prednisolone or similar placebo, once daily for 3 days.
MAIN OUTCOME MEASURES


Primary outcome was change in Preschool Respiratory Assessment Measure (PRAM) score 24 hours after intervention. Secondary outcomes included PRAM score at 4 hours, length of emergency department and inpatient stays, admission and representation rates, time to return to normal activities and use of additional oral prednisolone or intravenous medications. Analysis was by intention-to-treat.
RESULTS


There was no difference between groups for change in PRAM score at 24 hours (difference between means -0.39, 95% CI -0.84 to 0.06, p=0.09). Absolute PRAM score was lower in the prednisolone group at 4 hours (median (IQR) 1 (0-2) vs 2 (0-3), p=0.01) and 24 hours (0 (0-1) vs 0 (0-1), p=0.01), when symptoms had resolved for most children regardless of initial treatment. Admission rate, requirement for additional oral prednisolone and use of intravenous medication were lower in the prednisolone group, although there were no differences between groups for time taken to return to normal activities or rates of representation within 7 days.
CONCLUSION


Oral prednisolone does not alter respiratory outcomes at 24 hours or beyond in preschool children presenting with acute wheeze.",2020,"CONCLUSION


Oral prednisolone does not alter respiratory outcomes at 24 hours or beyond in preschool children presenting with acute wheeze.","['acute preschool wheeze', 'Three hospitals in New Zealand', 'preschool children presenting with acute wheeze', 'preschool children with acute wheeze alters respiratory outcomes', '477 children aged 24-59 months with acute wheeze associated with respiratory illness']","['oral corticosteroids', 'placebo', 'oral prednisolone or similar placebo', 'prednisolone', 'oral prednisolone']","['PRAM score at 4 hours, length of emergency department and inpatient stays, admission and representation rates, time to return to normal activities and use of additional oral prednisolone or intravenous medications', 'respiratory outcomes', 'time taken to return to normal activities or rates of representation', 'change in Preschool Respiratory Assessment Measure (PRAM) score', 'Absolute PRAM score', 'Admission rate, requirement for additional oral prednisolone and use of intravenous medication', 'PRAM score']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0358513', 'cui_str': 'Prednisolone-containing product in oral dose form'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0549075', 'cui_str': 'Respiratory assessment'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0420512', 'cui_str': 'Inpatient stay'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0358513', 'cui_str': 'Prednisolone-containing product in oral dose form'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",477.0,0.727444,"CONCLUSION


Oral prednisolone does not alter respiratory outcomes at 24 hours or beyond in preschool children presenting with acute wheeze.","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Wallace', 'Affiliation': 'Department of Paediatrics, Waikato Hospital, Hamilton, New Zealand.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Sinclair', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Shepherd', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Neutze', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Trenholme', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Eunicia', 'Initials': 'E', 'LastName': 'Tan', 'Affiliation': 'Emergency Department, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Brabyn', 'Affiliation': 'Emergency Department, Waikato Hospital, Hamilton, New Zealand.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Bonisch', 'Affiliation': ""Children's Emergency Department, Starship Children's Health, Auckland, New Zealand.""}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Grey', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': 'Departments of Paediatrics, Emergency Medicine, and Pharmacology and Physiology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McNamara', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'John M D', 'Initials': 'JMD', 'LastName': 'Thompson', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Innes', 'Initials': 'I', 'LastName': 'Asher', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Dalziel', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand s.dalziel@auckland.ac.nz.'}]",Archives of disease in childhood,['10.1136/archdischild-2020-318971']
1082,33067319,"Axitinib plus avelumab in the treatment of recurrent glioblastoma: a stratified, open-label, single-center phase 2 clinical trial (GliAvAx).","BACKGROUND


No treatment demonstrated to improve survival in patients with recurrent glioblastoma (rGB) in a randomized trial. Combining axitinib with the programmed cell death ligand 1 blocking monoclonal antibody avelumab may result in synergistic activity against rGB.
METHODS


Adult patients with rGB following prior surgery, radiation therapy and temozolomide chemotherapy were stratified according to their baseline use of corticosteroids. Patients with a daily dose of ≤8 mg of methylprednisolone (or equivalent) initiated treatment with axitinib (5 mg oral two times per day) plus avelumab (10 mg/kg intravenous every 2 weeks) (Cohort-1). Patients with a higher baseline corticosteroid dose initiated axitinib monotherapy; avelumab was added after 6 weeks of therapy if the corticosteroid dose could be tapered to ≤8 mg of methylprednisolone (Cohort-2). Progression-free survival at 6 months (6-m-PFS%), per immunotherapy response assessment for neuro-oncology criteria, served as the primary endpoint.
RESULTS


Between June 2017 and August 2018, 54 patients (27 per cohort) were enrolled and initiated study treatment (median age: 55 years; 63% male; 91% Eastern Cooperative Oncology Group Performance Status 0-1). Seventeen (63%) patients treated in Cohort-2 received at least one dose of avelumab. The 6-m-PFS% was 22.2% (95% CI 6.5% to 37.9%) and 18.5% (95% CI 3.8% to 33.2%) in Cohort-1 and Cohort-2, respectively; median overall survival was 26.6 weeks (95% CI 20.8 to 32.4) in Cohort-1 and 18.0 weeks (95% CI 12.5 to 23.5) in Cohort-2. The best objective response rate was 33.3% and 22.2% in Cohort-1 and Cohort-2, respectively, with a median duration of response of 17.9 and 19.0 weeks. The most frequent treatment-related adverse events were dysphonia (67%), lymphopenia (50%), arterial hypertension and diarrhea (both 48%). There were no grade 5 adverse events.
CONCLUSION


The combination of avelumab plus axitinib has an acceptable toxicity profile but did not meet the prespecified threshold for activity justifying further investigation of this treatment in an unselected population of patients with rGB.",2020,"The best objective response rate was 33.3% and 22.2% in Cohort-1 and Cohort-2, respectively, with a median duration of response of 17.9 and 19.0 weeks.","['Adult patients with rGB following prior surgery', 'patients with recurrent glioblastoma (rGB', 'recurrent glioblastoma', 'Between June 2017 and August 2018, 54 patients (27 per cohort) were enrolled and initiated study treatment (median age: 55 years; 63% male; 91% Eastern Cooperative Oncology Group Performance Status 0-1']","['radiation therapy and temozolomide chemotherapy', 'methylprednisolone', 'Axitinib plus avelumab', 'avelumab', 'avelumab plus axitinib', 'axitinib']","['lymphopenia', '6-m-PFS', 'Progression-free survival', 'arterial hypertension and diarrhea', 'median overall survival', 'objective response rate', 'survival']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0455610', 'cui_str': 'H/O: surgery'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4055417', 'cui_str': 'avelumab'}]","[{'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.226783,"The best objective response rate was 33.3% and 22.2% in Cohort-1 and Cohort-2, respectively, with a median duration of response of 17.9 and 19.0 weeks.","[{'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Awada', 'Affiliation': 'Medical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Ben Salama', 'Affiliation': 'Medical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'De Cremer', 'Affiliation': 'Psychology, Vrije Universiteit Brussel, Brussels, Brussels, Belgium.'}, {'ForeName': 'Julia Katharina', 'Initials': 'JK', 'LastName': 'Schwarze', 'Affiliation': 'Medical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Fischbuch', 'Affiliation': 'Medical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Seynaeve', 'Affiliation': 'Neurology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Du Four', 'Affiliation': 'Neurosurgery, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Vanbinst', 'Affiliation': 'Radiology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Michotte', 'Affiliation': 'Pathology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Everaert', 'Affiliation': 'Nuclear Medicine, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rogiers', 'Affiliation': 'Psychiatry, Centre Hospitalier Universitaire Brugmann, Brussels, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Theuns', 'Affiliation': 'Psychology, Vrije Universiteit Brussel, Brussels, Brussels, Belgium.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Duerinck', 'Affiliation': 'Neurosurgery, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Neyns', 'Affiliation': 'Medical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium bart.neyns@uzbrussel.be.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-001146']
1083,33067493,Resistance exercise training for anxiety and worry symptoms among young adults: a randomized controlled trial.,"This trial quantified the effects of ecologically-valid resistance exercise training (RET) on anxiety and worry symptoms among young adults. Young adults not meeting criteria for subclinical, or analogue Generalized Anxiety Disorder (AGAD) were randomized to an eight-week RET intervention, or eight-week wait-list. AGAD status was determined using validated cut-scores for both the Psychiatric Diagnostic Screening Questionnaire-Generalized Anxiety Disorder subscale (≥ 6) and Penn State Worry Questionnaire (≥ 45). The primary outcome was anxiety symptoms measured with the Trait Anxiety subscale of the State-Trait Anxiety Inventory. The RET was designed according to World Health Organization and American College of Sports Medicine guidelines. RM-ANCOVA examined differences between RET and wait-list over time. Significant interactions were decomposed with simple effects analysis. Hedges' d effect sizes quantified magnitude of differences in change between RET and wait-list. Twenty-eight participants (64% female) fully engaged in the trial (mean age: 26.0 ± 6.2y, RET: n = 14; Wait-list: n = 14). A significant group X time interaction was found for anxiety symptoms (F (3,66)  = 3.60, p ≤ 0.019; d = 0.85, 95%CI: 0.06 to 1.63). RET significantly reduced anxiety symptoms from baseline to post-intervention (mean difference =  - 7.89, p ≤ 0.001). No significant interaction was found for worry (F (3,69)  = 0.79, p ≥ 0.50; d =  - 0.22, 95%CI: - 0.96 to 0.53). Ecologically-valid RET significantly improves anxiety symptoms among young adults.Trial Registration: Clinicaltrials.gov Identifier: NCT04116944, 07/10/2019.",2020,"RET significantly reduced anxiety symptoms from baseline to post-intervention (mean difference =  - 7.89, p ≤ 0.001).","['Twenty-eight participants (64% female) fully engaged in the trial (mean age: 26.0\u2009±\u20096.2y, RET: n\u2009=\u200914; Wait-list: n\u2009=\u200914', 'young adults', 'Young adults not meeting criteria for subclinical, or analogue Generalized Anxiety Disorder (AGAD']","['Resistance exercise training', 'RET', 'ecologically-valid resistance exercise training (RET']","['anxiety symptoms measured with the Trait Anxiety subscale of the State-Trait Anxiety Inventory', 'Psychiatric Diagnostic Screening Questionnaire-Generalized Anxiety Disorder subscale (≥\u20096) and Penn State Worry Questionnaire', 'anxiety and worry symptoms', 'anxiety symptoms']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C2959752', 'cui_str': 'Penn State worry questionnaire'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",28.0,0.108717,"RET significantly reduced anxiety symptoms from baseline to post-intervention (mean difference =  - 7.89, p ≤ 0.001).","[{'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Gordon', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Limerick, Limerick, Ireland. brg5334@psu.edu.'}, {'ForeName': 'Cillian P', 'Initials': 'CP', 'LastName': 'McDowell', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lyons', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Herring', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Limerick, Limerick, Ireland.'}]",Scientific reports,['10.1038/s41598-020-74608-6']
1084,33067624,"An epitope-based approach to use of HLA matched platelets for transfusion: a noninferiority, cross-over, randomised trial.","Platelet transfusion refractoriness results in adverse outcomes and increased healthcare costs. Managing refractoriness due to HLA alloimmunization necessitates the use of HLA antigen matched platelets, but requires a large platelet donor pool, and does not guarantee full matching. We report the first ever randomized, double-blind, non-inferiority, cross-over trial comparing HLA epitope-matched (HEM) platelets with HLA standard antigen-matched (HSM) platelet transfusions. Eligibility criteria were alloimmunized, platelet refractory, thrombocytopenic patients with aplastic anemia, myelodysplastic syndrome or acute myeloid leukemia. HEM platelets were selected using HLAMatchMaker epitope (specifically eplet) matching. Patients received up to eight prophylactic HEM and HSM transfusions provided in random order. Primary outcome was one-hour post transfusion platelet count increment (PCI). 49 patients were randomized at 14 UK hospitals. For intention-to-treat, number of evaluable transfusions was 107 and 112 for HEM and HSM, respectively. Unadjusted mean (SD) PCI for HEM and HSM was 23.9 (15) and 23.5 (14.1) respectively (adjusted mean difference -0.1, 95% CI -2.9, 2.8). As the lower limit of 95% CI was not greater than pre-defined non-inferiority limit, HEM was declared non-inferior to HSM. There were no differences in secondary outcomes of platelet counts, transfusion requirements and bleeding events. Adequate one-hour PCI was more frequently observed with a mean number of 3.2 of epitope mismatches compared to 5.5 epitope mismatches for inadequate one-hour increments. For every additional one epitope mismatch, the likelihood of an adequate PCI decreased by 15%. Epitope matched platelets should be considered to support HLA alloimmunized patients. Funded by NHS Blood and Transplant, ISRCTN23996532.",2020,"There were no differences in secondary outcomes of platelet counts, transfusion requirements and bleeding events.","['49 patients were randomized at 14 UK hospitals', 'thrombocytopenic patients with aplastic anemia, myelodysplastic syndrome or acute myeloid leukemia']","['prophylactic HEM and HSM transfusions', 'HLA epitope-matched (HEM) platelets with HLA standard antigen-matched (HSM) platelet transfusions']","['hour post transfusion platelet count increment (PCI', 'Unadjusted mean (SD) PCI for HEM and HSM', 'healthcare costs', 'adequate PCI', 'platelet counts, transfusion requirements and bleeding events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002874', 'cui_str': 'Aplastic anemia'}, {'cui': 'C2347761', 'cui_str': 'Childhood myelodysplastic syndrome'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0003316', 'cui_str': 'Epitope'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0086818', 'cui_str': 'Platelet transfusion'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0003316', 'cui_str': 'Epitope'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",49.0,0.201413,"There were no differences in secondary outcomes of platelet counts, transfusion requirements and bleeding events.","[{'ForeName': 'Judith C', 'Initials': 'JC', 'LastName': 'Marsh', 'Affiliation': ""King's College Hospital, London, United Kingdom.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Stanworth', 'Affiliation': 'University of Oxford, United Kingdom.'}, {'ForeName': 'Laura Anne', 'Initials': 'LA', 'LastName': 'Pankhurst', 'Affiliation': 'NHS Blood and Transplant, Bristol, United Kingdom.'}, {'ForeName': 'Delordson', 'Initials': 'D', 'LastName': 'Kallon', 'Affiliation': 'Barts and The London Hospital, London, United Kingdom.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Gilbertson', 'Affiliation': ""Guy's Hospital, London, United Kingdom.""}, {'ForeName': 'Collette', 'Initials': 'C', 'LastName': 'Pigden', 'Affiliation': ""King's College, London.""}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Deary', 'Affiliation': 'NHS Blood and Transplant, Cambridge, United Kingdom.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Mora', 'Affiliation': 'NHS Blood and Transplant, Cambridge, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'NHS Blood and Transplant, Cambridge, United Kingdom.'}, {'ForeName': 'Emma S', 'Initials': 'ES', 'LastName': 'Laing', 'Affiliation': 'NHS Blood and Transplant, Cambridge, United Kingdom.'}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Choo', 'Affiliation': 'University College London, London, United Kingdom.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Hodge', 'Affiliation': 'NHS Blood and Transplant, Cambridge, United Kingdom.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Llewelyn', 'Affiliation': 'NHS Blood and Transplant, Cambridge, United Kingdom.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Harding', 'Affiliation': 'NHS Blood and Transplant, Cambridge, United Kingdom.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Sage', 'Affiliation': 'NHS Blood and Transplant, London, United Kingdom.'}, {'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Mijovic', 'Affiliation': ""King's College Hospital NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Ghulam J', 'Initials': 'GJ', 'LastName': 'Mufti', 'Affiliation': ""Guy's, King's and St. Thomas' School of Medicine, London, United Kingdom.""}, {'ForeName': 'Cristina V', 'Initials': 'CV', 'LastName': 'Navarrete', 'Affiliation': 'NHS Blood and Transplant, London, United Kingdom.'}, {'ForeName': 'Colin Joseph', 'Initials': 'CJ', 'LastName': 'Brown', 'Affiliation': 'NHS Blood and Transplant, London, United Kingdom.'}]",Blood,['10.1182/blood.2020007199']
1085,33067675,Changes in gut microbial flora after Roux-en-Y gastric bypass and sleeve gastrectomy and their effects on post-operative weight loss.,"Bariatric surgery affects gut microbial flora due to the anatomical and physiological changes it causes in the gastrointestinal tract. Understanding the interaction between the gut flora, the type of bariatric surgery and weight loss may help improve bariatric surgery outcomes. This study was designed to compare the effects of Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) on two main phyla of the gut microbiota in humans and evaluate their potential effect on weight changes. Thirty morbidly obese patients were divided into two groups and underwent laparoscopic SG or laparoscopic RYGB. The patients' weight changes and fecal samples were evaluated at baseline and 6 months after the surgery. A microbial flora count was carried out of the phyla Bacteroidetes and Firmicutes and Bacteroides Fragilis. Changes in the abundance of the flora and their correlation with weight loss were analyzed. After 6 months, the patients with a history of RYGB showed a significant decrease in stool Bacteroidetes while the reduction in the SG group was insignificant. Firmicutes abundance was almost unchanged following SG and RYGB. There was no significant change in Bacteroides Fragilis abundance in either of the two groups, but a positive correlation was observed between Bacteroides Fragilis and weight loss after SG and RYGB. Bariatric surgery can affect gut microbiota. It can be concluded that these changes are dependent on many factors and may play a role in weight loss.",2020,"There was no significant change in Bacteroides Fragilis abundance in either of the two groups, but a positive correlation was observed between Bacteroides Fragilis and weight loss after SG and RYGB.",['Thirty morbidly obese patients'],"['Bariatric surgery', 'Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG', 'Roux-en-Y gastric bypass and sleeve gastrectomy', 'laparoscopic SG or laparoscopic RYGB']","['weight loss', 'weight changes', 'Bacteroides Fragilis and weight loss', 'weight changes and fecal samples', 'Bacteroides Fragilis abundance', 'stool Bacteroidetes', 'Firmicutes abundance']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",30.0,0.0128524,"There was no significant change in Bacteroides Fragilis abundance in either of the two groups, but a positive correlation was observed between Bacteroides Fragilis and weight loss after SG and RYGB.","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Karami', 'Affiliation': 'Minimally Invasive Surgery Research Center, Iran University of Medical Sciences, Rasool-E-Akram Hospital, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kermansaravi', 'Affiliation': 'Minimally Invasive Surgery Research Center, Iran University of Medical Sciences, Rasool-E-Akram Hospital, Tehran, Iran. mkermansaravi@yahoo.com.'}, {'ForeName': 'Mohaddese', 'Initials': 'M', 'LastName': 'Pishgahroudsari', 'Affiliation': 'BS, Statistics Analyzer, Minimally Invasive Surgery Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Talebi', 'Affiliation': 'Department of Microbiology, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Mohammadzadeh', 'Affiliation': 'Department of Microbiology, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Pazouki', 'Affiliation': 'Minimally Invasive Surgery Research Center, Iran University of Medical Sciences, Rasool-E-Akram Hospital, Tehran, Iran.'}]",Updates in surgery,['10.1007/s13304-020-00900-9']
1086,33067692,Scalp Topography of Lower Urinary Tract Sensory Evoked Potentials.,"Impaired lower urinary tract (LUT) afferents often cause LUT symptoms. Assessment of LUT afferent pathways is possible using bipolar cortical sensory evoked potential (SEP) recordings with the active electrode at the vertex during electrical stimulation in the LUT. This study aimed to investigate the topographical distribution and microstates of lower urinary tract sensory evoked potentials (LUTSEPs) using different stimulation frequencies. Ninety healthy subjects (18-36 years old, 40 women) were randomly assigned to one of five stimulation locations [bladder dome; trigone; proximal, membranous (men only) or distal urethra]. Cycles of 0.5 Hz/1.1 Hz/1.6 Hz electrical stimulation were applied using a custom-made catheter. Cortical activity was recorded from 64 surface electrodes. Marker setting was performed manually on an individual subject-level for the P1, N1, and P2 components of vertex recordings. N1 and P2 topographies presented with central negativities and positivities around the vertex. Regarding topographical distribution, Randomization Graphical User interface (RAGU) analyses revealed consistent frequency effects and microstates for N1/P2. Higher stimulation frequencies resulted in decreasing map strength for P1, N1, and P2. LUTSEP topographies suggest central generators in the somatosensory cortex, which are not detectable in a bipolar set-up. The observed frequency effect indicates fiber refractoriness at higher frequencies. The multichannel approach allows more comprehensive assessment of LUTSEPs and might therefore be sensitive to pathological changes. Examinations in patients with LUT symptoms are needed to further investigate this biomarker.",2020,"Higher stimulation frequencies resulted in decreasing map strength for P1, N1, and P2.","['patients with LUT symptoms', 'Ninety healthy subjects (18-36\xa0years old, 40 women']","['Hz electrical stimulation', 'five stimulation locations [bladder dome; trigone; proximal, membranous (men only) or distal urethra']","['map strength for P1, N1, and P2', 'Cortical activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0444914', 'cui_str': 'Domed'}, {'cui': 'C0447586', 'cui_str': 'Trigonal structure'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}]","[{'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",90.0,0.0382707,"Higher stimulation frequencies resulted in decreasing map strength for P1, N1, and P2.","[{'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'van der Lely', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Forchstrasse 340, 8008, Zürich, Switzerland.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kessler', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Forchstrasse 340, 8008, Zürich, Switzerland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mehnert', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Forchstrasse 340, 8008, Zürich, Switzerland.'}, {'ForeName': 'Martina D', 'Initials': 'MD', 'LastName': 'Liechti', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Forchstrasse 340, 8008, Zürich, Switzerland. martina.liechti@balgrist.ch.'}]",Brain topography,['10.1007/s10548-020-00796-z']
1087,33067735,Transrectus sheath pre-peritoneal (TREPP) procedure versus totally extraperitoneal (TEP) procedure and Lichtenstein technique: a propensity-score-matched analysis in Dutch high-volume regional hospitals.,"PURPOSE


Results of the most commonly used inguinal hernia repair techniques often originate from expert centers or from randomized controlled studies. In this study, we portray daily-practice results of a high-volume, regional surgical group in the Netherlands, comparing TREPP (open (posterior) transrectus sheath pre-peritoneal) with Lichtenstein (open anterior) and TEP (endoscopic (posterior) totally extraperitoneal). We hypothesize that the TREPP shows more favorable outcome compared to the current gold standard procedures: TEP and Lichtenstein.
METHODS


Between January 2016 and December 2018, 3285 consecutive patients underwent surgical treatment and were included for analysis. The outcome measures were postoperative pain, recurrence rate and other surgical complications. Propensity-score matching was used to address potential selection bias.
RESULTS


After propensity-score matching, there was no statistically significant difference in postoperative pain in the TREPP group compared to the Lichtenstein group (TREPP 7.3% versus Lichtenstein 6.3%; p = 0.67) nor in TREPP compared to TEP (TREPP 7.4% versus TEP 4.1%; p = 0.064). There was no statistically significant difference in recurrences in the TREPP group compared to Lichtenstein (3.8% vs 2.5%; p = 0.42), nor in the TREPP versus TEP comparison (3.9% vs 2.8%; p = 0.55) CONCLUSION: This study compares TREPP with Lichtenstein and TEP in the presence of postoperative pain, recurrences and other adverse outcomes. After propensity-score matching, no statistically significant difference in postoperative pain or recurrences remained between either TREPP compared to Lichtenstein, or TREPP compared to TEP. Based on these results, TREPP, Lichtenstein and TEP showed comparable results in postoperative pain, recurrences and other surgical site complications.",2020,"After propensity-score matching, no statistically significant difference in postoperative pain or recurrences remained between either TREPP compared to Lichtenstein, or TREPP compared to TEP.","['Dutch high-volume regional hospitals', 'Between January 2016 and December 2018, 3285 consecutive patients underwent surgical treatment and were included for analysis']","['inguinal hernia repair techniques', 'TREPP with Lichtenstein and TEP', 'Lichtenstein', 'TREPP', 'TREPP, Lichtenstein and TEP', 'Transrectus sheath pre-peritoneal (TREPP) procedure versus totally extraperitoneal (TEP) procedure and Lichtenstein technique', 'TREPP (open (posterior) transrectus sheath pre-peritoneal) with Lichtenstein (open anterior) and TEP (endoscopic (posterior) totally extraperitoneal']","['recurrences', 'postoperative pain, recurrences and other surgical site complications', 'postoperative pain or recurrences', 'postoperative pain, recurrence rate and other surgical complications', 'postoperative pain']","[{'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0145334', 'cui_str': 'tetraethylpyrazine'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0198588', 'cui_str': 'Procedure on peritoneum'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",3285.0,0.0712531,"After propensity-score matching, no statistically significant difference in postoperative pain or recurrences remained between either TREPP compared to Lichtenstein, or TREPP compared to TEP.","[{'ForeName': 'T L R', 'Initials': 'TLR', 'LastName': 'Zwols', 'Affiliation': 'Department of Surgery, Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands. thomas.zwols@znb.nl.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Slagter', 'Affiliation': 'Department of Surgery, Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'N J G M', 'Initials': 'NJGM', 'LastName': 'Veeger', 'Affiliation': 'Department of Clinical Epidemiology, Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'M J W', 'Initials': 'MJW', 'LastName': 'Möllers', 'Affiliation': 'Department of Surgery, Nij Smellinghe, Drachten, The Netherlands.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Hess', 'Affiliation': 'Department of Surgery, Antonius Ziekenhuis, Sneek, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jutte', 'Affiliation': 'Department of Surgery, Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'H T', 'Initials': 'HT', 'LastName': 'Brandsma', 'Affiliation': 'Department of Surgery, Antonius Ziekenhuis, Sneek, The Netherlands.'}, {'ForeName': 'P H J M', 'Initials': 'PHJM', 'LastName': 'Veldman', 'Affiliation': 'Department of Surgery, Tjongerschans Heerenveen, Heerenveen, The Netherlands.'}, {'ForeName': 'G G', 'Initials': 'GG', 'LastName': 'Koning', 'Affiliation': 'Department of Surgery, Ikazia Ziekenhuis, Rotterdam, The Netherlands.'}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Eker', 'Affiliation': 'Department of Surgery, Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'J P E N', 'Initials': 'JPEN', 'LastName': 'Pierie', 'Affiliation': 'Department of Surgery, Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands.'}]",Hernia : the journal of hernias and abdominal wall surgery,['10.1007/s10029-020-02291-7']
1088,33067755,Retraction Note to: The efficacy of Guolin-Qigong on the body-mind health of Chinese women with breast cancer: a randomized controlled trial.,This article has been retracted. Please see the Retraction Notice for more detail: https://doi.org/10.1007/s11136-017-1576-7.,2020,Please see the Retraction Notice for more detail: https://doi.org/10.1007/s11136-017-1576-7.,['Chinese women with breast cancer'],['Guolin-Qigong'],[],"[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0282077', 'cui_str': 'Qigong'}]",[],,0.0386953,Please see the Retraction Notice for more detail: https://doi.org/10.1007/s11136-017-1576-7.,"[{'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Jieshu', 'Initials': 'J', 'LastName': 'You', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Wing T Y', 'Initials': 'WTY', 'LastName': 'Loo', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Youzhi', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Sit', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Meikuen', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Xia', 'Affiliation': ""School of Public Health, Peking University, Beijing, 100191, People's Republic of China.""}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Neng', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Lixing', 'Initials': 'L', 'LastName': 'Lao', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong. abchen@hku.hk.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02672-6']
1089,33067767,Feeling scared or worried self-report in children receiving cancer treatments using the Symptom Screening in Pediatrics Tool (SSPedi).,"INTRODUCTION


The objectives of this study were to describe reports of bother for feeling scared or worried among children with cancer and pediatric hematopoietic stem cell transplant (HSCT) recipients, and to identify factors associated with it.
METHODS


We included children receiving cancer treatments who were 8-18 years of age. Three patient types were enrolled: inpatients receiving active cancer treatment, outpatients receiving maintenance acute lymphoblastic leukemia chemotherapy, and outpatients in survivorship. Amount of bother due to feeling scared or worried yesterday or today was self-reported using the Symptom Screening in Pediatrics Tool (SSPedi) on a 0-4 scale. Risk factors were evaluated using logistic regression.
RESULTS


Among the 502 children included, 225 (45.0%) reported any degree of bother (score ≥ 1) and 29 (5.8%) reported severe bother (score ≥ 3) for feeling scared or worried. In multiple regression evaluating any bother, boys were less likely to be bothered (odds ratio (OR) 0.60, 95% confidence interval (CI) 0.41-0.87) and inpatients receiving active cancer treatment were more likely to be bothered compared to outpatients in survivorship (OR 3.58, 95% CI 2.00-6.52). The only factor associated with being severely bothered by feeling scared or worried was clinic visit or admission due to fever (OR 4.57, 95% CI 1.24-13.60).
DISCUSSION


We found 45% of children receiving cancer treatments reported being bothered by feeling scared or worried. Girls and inpatients receiving active treatment experienced more bother of any degree, while visiting the hospital due to fever was associated with being severely bothered. Future work should identify interventions to prevent or alleviate this symptom.",2020,"In multiple regression evaluating any bother, boys were less likely to be bothered (odds ratio (OR) 0.60, 95% confidence interval (CI) 0.41-0.87) and inpatients receiving active cancer treatment were more likely to be bothered compared to outpatients in survivorship (OR 3.58, 95% CI 2.00-6.52).","['children receiving cancer treatments who were 8-18\xa0years of age', 'Three patient types were enrolled: inpatients receiving active cancer treatment, outpatients receiving maintenance acute lymphoblastic leukemia chemotherapy, and outpatients in survivorship', '502 children', 'children with cancer and pediatric hematopoietic stem cell transplant (HSCT) recipients', 'children receiving cancer treatments using the Symptom Screening in Pediatrics Tool (SSPedi']",[],"['feeling scared or worried was clinic visit or admission due to fever', 'feeling scared or worried', 'severe bother', 'bother of any degree, while visiting the hospital due to fever']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]",[],"[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",502.0,0.0457444,"In multiple regression evaluating any bother, boys were less likely to be bothered (odds ratio (OR) 0.60, 95% confidence interval (CI) 0.41-0.87) and inpatients receiving active cancer treatment were more likely to be bothered compared to outpatients in survivorship (OR 3.58, 95% CI 2.00-6.52).","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Hyslop', 'Affiliation': 'Program in Child Health Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning, 686 Bay Street, Toronto, Ontario, M5G 0A4, Canada.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Tomlinson', 'Affiliation': 'Program in Child Health Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning, 686 Bay Street, Toronto, Ontario, M5G 0A4, Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Baggott', 'Affiliation': 'Pediatric Hematology/Oncology, Stanford University Cancer Clinical Trials Office, 800 Welch Road, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dix', 'Affiliation': ""Division of Hematology/Oncology/BMT, Department of Pediatrics, BC Children's Hospital, 4480 Oak Street Room B315, Vancouver, V6H 3V4, Canada.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gibson', 'Affiliation': 'Haematology/Oncology, Department of Pediatrics, London Health Sciences Centre, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Donna L', 'Initials': 'DL', 'LastName': 'Johnston', 'Affiliation': ""Division of Hematology/Oncology, Children's Hospital of Eastern Ontario, 401 Smyth Road, Ottawa, Ontario, K1H 8L1, Canada.""}, {'ForeName': 'Andrea D', 'Initials': 'AD', 'LastName': 'Orsey', 'Affiliation': ""Division of Pediatric Hematology/Oncology, Connecticut Children's Medical Center, 282 Washington Street, Hartford, CT, 06106, USA.""}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Portwine', 'Affiliation': ""Division of Haematology/Oncology, McMaster Children's Hospital, Health Sciences Centre, 1280 Main Street West, Hamilton, Ontario, L8S 4K1, Canada.""}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Price', 'Affiliation': 'Division of Pediatric Hematology/Oncology, Department of Pediatrics, IWK Health Centre, 5850/5980 University Avenue, Halifax, Nova Scotia, B3K 6R8, Canada.'}, {'ForeName': 'Magimairajan', 'Initials': 'M', 'LastName': 'Vanan', 'Affiliation': 'Pediatric Hematology/Oncology/BMT, CancerCare Manitoba, Research Institute in Oncology and Hematology, Departments of Pediatrics & Child Health and Biochemistry & Medical Genetics, University of Manitoba, 675 McDermot Avenue, Winnipeg, Manitoba, R3E 0V9, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kuczynski', 'Affiliation': 'Ontario Parents Advocating for Children with Cancer (OPACC), 99 Citation Drive, Toronto, Ontario, M2K 1S9, Canada.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Spiegler', 'Affiliation': 'Department of Psychology, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, M5G 1X8, Canada.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Tomlinson', 'Affiliation': 'Department of Medicine, Toronto General Hospital, 200 Elizabeth Street, Toronto, Ontario, M5G 2C4, Canada.'}, {'ForeName': 'L Lee', 'Initials': 'LL', 'LastName': 'Dupuis', 'Affiliation': 'Program in Child Health Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning, 686 Bay Street, Toronto, Ontario, M5G 0A4, Canada.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Sung', 'Affiliation': 'Program in Child Health Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning, 686 Bay Street, Toronto, Ontario, M5G 0A4, Canada. lillian.sung@sickkids.ca.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05818-x']
1090,33067769,The Effect of Family Member Attendance at Bariatric Surgery Appointments on Patient and Family Weight-Related Outcomes.,"PURPOSE


To assess the effect of family member attendance at routine pre- and postoperative appointments on early postoperative patients' weight loss and physical activity levels and family members' weight control practices.
MATERIALS AND METHODS


As part of a RCT, patients were randomized to (1) invite a romantic partner or cohabitating family member to attend routine appointments (FA arm) or (2) proceed with treatment as usual (TAU arm). Patients in FA arm were asked to invite their family member to attend four routine appointments (T1 = pre-surgery class, T2 = 1 month pre-surgery, T3 = 2 weeks post-surgery, T4 = 2 months post-surgery). Assessments of patients' percent excess weight loss (%EWL), change in body mass index (ΔBMI), and levels of physical activity and family members' weight control practices (dietary control, self-monitoring, physical activity, and psychological coping) were conducted at T1-T4 with all dyads, and attendance was documented. Of the 213 dyads approached, 63 dyads consented to participate.
RESULTS


There were no significant differences in patient outcomes between FA and TAU arms or based on consistent attendance of family members. There were no significant differences in weight control practices between FA and TAU dyads. At T3 and T4, family members with consistent attendance reported higher self-monitoring, physical activity, and psychological control practices. Family members with consistent attendance reported significant increases in physical activity and psychological control practices from T1 to T4.
CONCLUSIONS


Family member attendance at routine appointments had greater positive effects on family members rather than on patient outcomes.",2020,"At T3 and T4, family members with consistent attendance reported higher self-monitoring, physical activity, and psychological control practices.","['213 dyads approached, 63 dyads consented to participate']","['Family Member Attendance at Bariatric Surgery Appointments', 'romantic partner or cohabitating family member to attend routine appointments (FA arm) or (2) proceed with treatment as usual (TAU arm']","['weight control practices', 'self-monitoring, physical activity, and psychological control practices', 'physical activity and psychological control practices', ""excess weight loss (%EWL), change in body mass index (ΔBMI), and levels of physical activity and family members' weight control practices (dietary control, self-monitoring, physical activity, and psychological coping""]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}]",213.0,0.0314503,"At T3 and T4, family members with consistent attendance reported higher self-monitoring, physical activity, and psychological control practices.","[{'ForeName': 'Megan Ferriby', 'Initials': 'MF', 'LastName': 'Ferber', 'Affiliation': 'Department of Human Sciences, Human Development and Family Science Program, The Ohio State University, Columbus, OH, USA. megan.ferber@health.slu.edu.'}, {'ForeName': 'Sabrena', 'Initials': 'S', 'LastName': 'Noria', 'Affiliation': 'Department of Surgery, Division of General and GI Surgery, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Focht', 'Affiliation': 'Department of Human Sciences, Kinesiology Program, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Wallace', 'Affiliation': 'Department of Family Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Needleman', 'Affiliation': 'Department of Surgery, Division of General and GI Surgery, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Keeley J', 'Initials': 'KJ', 'LastName': 'Pratt', 'Affiliation': 'Department of Human Sciences, Human Development and Family Science Program, The Ohio State University, Columbus, OH, USA.'}]",Obesity surgery,['10.1007/s11695-020-05041-x']
1091,33067856,"Evaluating the effectiveness of the smartphone app, Drink Less, compared with the NHS alcohol advice webpage, for the reduction of alcohol consumption among hazardous and harmful adult drinkers in the UK at six-month follow-up: protocol for a randomised controlled trial.","BACKGROUND AND AIMS


Digital interventions are effective for reducing alcohol consumption but evidence is limited regarding smartphone apps. Drink Less is a theory- and evidence-informed app to help people reduce their alcohol consumption that has been refined in terms of its content and design for usability across the socio-demographic spectrum. We aim to evaluate the effectiveness and cost-effectiveness of recommending Drink Less at reducing alcohol consumption compared with usual digital care.
DESIGN


Two-arm individually randomised controlled trial.
SETTING


Online trial in the UK.
PARTICIPANTS


Hazardous or harmful drinkers (Alcohol Use Disorders Identification Test [AUDIT] score >=8) aged 18+ who want to drink less alcohol (n=5,562). Participants will be recruited from July 2020 to May 2022 using multiple strategies with a focus on remote digital methods.
INTERVENTION AND COMPARATOR


Participants will be randomised to receive either an email recommending that they use Drink Less (intervention) or view the NHS webpage on alcohol advice (comparator).
MEASUREMENTS


The primary outcome is change in self-reported weekly alcohol consumption, assessed using the extended AUDIT-Consumption, between baseline and 6-month follow-up. Secondary outcomes include change in self-reported weekly alcohol consumption assessed at 1 and 3-month follow-ups, and the proportion of hazardous drinkers; alcohol-related problems and injury; health-related quality of life; and use of health services assessed at 6-month follow-up. Effectiveness will be examined with adjusted regression models, adjusting for baseline alcohol consumption and using an intention-to-treat approach. A mixed-methods process evaluation will assess engagement, acceptability and mechanism of action. Economic evaluations will be conducted using both a short- and longer-term time horizon.
COMMENTS


This study will establish the effectiveness and cost-effectiveness of the Drink Less app at reducing alcohol consumption among hazardous and harmful adult drinkers and will be the first randomised controlled trial of an alcohol reduction app for the general population in the UK. This study will inform the decision on whether it is worth investing resources in large-scale implementation.",2020,"Secondary outcomes include change in self-reported weekly alcohol consumption assessed at 1 and 3-month follow-ups, and the proportion of hazardous drinkers; alcohol-related problems and injury; health-related quality of life; and use of health services assessed at 6-month follow-up.","['Participants will be recruited from July 2020 to May 2022 using multiple strategies with a focus on remote digital methods', 'Hazardous or harmful drinkers (Alcohol Use Disorders Identification Test [AUDIT] score >=8) aged 18+ who want to drink less alcohol (n=5,562', 'hazardous and harmful adult drinkers']",['email recommending that they use Drink Less (intervention) or view the NHS webpage on alcohol advice (comparator'],"['alcohol consumption', 'effectiveness and cost-effectiveness', 'change in self-reported weekly alcohol consumption assessed at 1 and 3-month follow-ups, and the proportion of hazardous drinkers; alcohol-related problems and injury; health-related quality of life; and use of health services', 'change in self-reported weekly alcohol consumption, assessed using the extended AUDIT-Consumption']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C2732658', 'cui_str': 'Alcohol use disorders identification test score'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.143132,"Secondary outcomes include change in self-reported weekly alcohol consumption assessed at 1 and 3-month follow-ups, and the proportion of hazardous drinkers; alcohol-related problems and injury; health-related quality of life; and use of health services assessed at 6-month follow-up.","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Garnett', 'Affiliation': 'University College London, Gower Street, London, WC1E 6BT.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Oldham', 'Affiliation': 'University College London, Gower Street, London, WC1E 6BT.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Angus', 'Affiliation': 'University of Sheffield, Western Bank, Sheffield, S10 2TN.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Beard', 'Affiliation': 'University College London, Gower Street, London, WC1E 6BT.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Burton', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Field', 'Affiliation': 'University of Sheffield, Western Bank, Sheffield, S10 2TN.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Greaves', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hickman', 'Affiliation': 'University of Bristol, Beacon House, Queens Road, Bristol, BS8 1QU.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kaner', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, NE1 7RU.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Loebenberg', 'Affiliation': 'University College London, Gower Street, London, WC1E 6BT.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Michie', 'Affiliation': 'University College London, Gower Street, London, WC1E 6BT.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Munafò', 'Affiliation': 'University of Bristol, Beacon House, Queens Road, Bristol, BS8 1QU.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pizzo', 'Affiliation': 'University College London, Gower Street, London, WC1E 6BT.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'University College London, Gower Street, London, WC1E 6BT.'}]","Addiction (Abingdon, England)",['10.1111/add.15287']
1092,33067919,Effectiveness of a Low-dose Mindfulness-based Intervention for Alleviating Distress in Young Unemployed Adults.,"While the effectiveness of mindfulness-based interventions (MBIs) with respect to distress has been widely researched, unemployed individuals, who often suffer from high levels of distress, have largely been neglected in MBI research. The present study aimed to investigate the effects of a low-dose MBI on distress in a sample of young unemployed adults. The sample included 239 young unemployed adults enrolled for a six-week long employability-related training camp. Participants were allocated into an intervention group that received weekly one-hour mindfulness training over 4 weeks, and a control group. Dispositional mindfulness, distress and well-being were assessed in the entire sample prior to the start and upon completion of the mindfulness training. A mixed-model ANCOVA showed that distress was inversely and significantly predicted by baseline levels of mindfulness and well-being. After accounting for the baseline levels of mindfulness and well-being, a significant effect of the mindfulness intervention was evident. This result shows that a low-dose MBI can decrease distress in a sample of young unemployed adults and its effectiveness is positively associated with initial levels of dispositional mindfulness and well-being. This article is protected by copyright. All rights reserved.",2020,"Dispositional mindfulness, distress and well-being were assessed in the entire sample prior to the start and upon completion of the mindfulness training.","['239 young unemployed adults enrolled for a six-week long employability-related training camp', 'young unemployed adults', 'Young Unemployed Adults']","['mindfulness-based interventions (MBIs', 'Low-dose Mindfulness-based Intervention', 'low-dose MBI']","['distress', 'Dispositional mindfulness, distress and well-being']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",239.0,0.0182494,"Dispositional mindfulness, distress and well-being were assessed in the entire sample prior to the start and upon completion of the mindfulness training.","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Roemer', 'Affiliation': 'University of Waikato, School of Psychology, Hamilton, 3240, New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sutton', 'Affiliation': 'University of Waikato, School of Psychology, Hamilton, 3240, New Zealand.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Grimm', 'Affiliation': 'New Zealand Defence Force.'}, {'ForeName': 'Oleg N', 'Initials': 'ON', 'LastName': 'Medvedev', 'Affiliation': 'University of Waikato, School of Psychology, Hamilton, 3240, New Zealand.'}]",Stress and health : journal of the International Society for the Investigation of Stress,['10.1002/smi.2997']
1093,33068016,Effects of family nursing conversations on families in home health care: A controlled before-and-after study.,"AIM


To assess the effects of family nursing conversations on family caregiver burden, patients' quality of life, family functioning and the amount of professional home health care.
DESIGN


A controlled before-and-after design.
METHODS


Intervention group families participated in two family nursing conversations incorporated in home health care; control group families received usual home health care. Patients and family members completed a set of questionnaires on entering the study and 6 months later to assess family caregiver burden, family functioning and patients' quality of life. The amount of home health care was extracted from patient files. Data were collected between January 2018-June 2019.
RESULTS


Data of 51 patients (mean age 80; 47% male) and 61 family members (mean age 67; 38% male) were included in the results. Family caregiver burden remained stable in the intervention group whereas it increased in the control group. Family functioning improved significantly compared with the control group for patients and family members in the intervention group. No significant effects on patients' quality of life emerged. The amount of professional home health care decreased significantly in the intervention group whereas it remained equal in the control group.
CONCLUSION


Family nursing conversations prevented family caregiver burden, improved family functioning, but did not affect patients' quality of life. In addition, the amount of home health care decreased following the family nursing conversations.
IMPACT


Countries with ageing populations seek to reduce professional and residential care and therefore encourage family caregiving. Intensive family caregiving, however, places families at risk for caregiver burden which may lead to increased professional care and admission into residential care. This study demonstrates that family nursing conversations help nurses to prevent family caregiver burden and improve family functioning while decreasing the amount of home health care.",2020,Family functioning improved significantly compared with the control group for patients and family members in the intervention group.,"['families in home health care', 'Intervention group families participated in two family', '51 patients (mean age 80; 47% male) and 61 family members (mean age 67; 38% male']","['nursing conversations incorporated in home health care; control group families received usual home health care', 'family nursing conversations']","[""family caregiver burden, family functioning and patients' quality of life"", 'Family functioning', 'Family caregiver burden', ""patients' quality of life emerged"", ""patients' quality of life"", 'amount of professional home health care']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0019855', 'cui_str': 'Services, Home Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0019855', 'cui_str': 'Services, Home Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0596559', 'cui_str': 'Family-Centered Nursing'}]","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0019855', 'cui_str': 'Services, Home Care'}]",,0.0226266,Family functioning improved significantly compared with the control group for patients and family members in the intervention group.,"[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Broekema', 'Affiliation': 'Research Group Nursing Diagnostics, Hanze University of Applied Sciences, Groningen, The Netherlands.'}, {'ForeName': 'Wolter', 'Initials': 'W', 'LastName': 'Paans', 'Affiliation': 'Research Group Nursing Diagnostics, Hanze University of Applied Sciences, Groningen, The Netherlands.'}, {'ForeName': 'Petrie F', 'Initials': 'PF', 'LastName': 'Roodbol', 'Affiliation': 'Faculty of Medical Sciences, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Marie Louise A', 'Initials': 'MLA', 'LastName': 'Luttik', 'Affiliation': 'Research Group Nursing Diagnostics, Hanze University of Applied Sciences, Groningen, The Netherlands.'}]",Journal of advanced nursing,['10.1111/jan.14599']
1094,33068037,Safety and Efficacy of Omaveloxolone in Friedreich's Ataxia (MOXIe Study).,"OBJECTIVE


Friedreich's ataxia (FRDA) is a progressive genetic neurodegenerative disorder with no approved treatment. Omaveloxolone, an Nrf2 activator, improves mitochondrial function, restores redox balance, and reduces inflammation in models of FRDA. We investigated the safety and efficacy of omaveloxolone in patients with FRDA.
METHODS


We conducted an international, double-blind, randomized, placebo-controlled parallel-group, registrational phase 2 trial at 11 institutions in the United States, Europe, and Australia (NCT02255435, EudraCT2015-002762-23). Eligible patients, 16 to 40 years of age with genetically confirmed FRDA and baseline modified Friedreich's Ataxia Rating Scale (mFARS) scores between 20 and 80, were randomized 1:1 to placebo or 150 mg per day of omaveloxolone. The primary outcome was change from baseline in the mFARS score in those treated with omaveloxolone compared with those on placebo at 48 weeks.
RESULTS


155 patients were screened and 103 were randomly assigned to receive omaveloxolone (n=51) or placebo (n=52), with 40 omaveloxolone patients and 42 placebo patients analyzed in the full analysis set. Changes from baseline in mFARS scores in omaveloxolone (-1.55 ± 0.69) and placebo (0.85 ± 0.64) patients showed a difference between treatment groups of -2.40 ± 0.96; p=0.014). Transient reversible increases in aminotransferase levels were observed with omaveloxolone without increases in total bilirubin or other signs of liver injury. Headache, nausea, and fatigue were also more common among patients receiving omaveloxolone.
INTERPRETATION


In the MOXIe trial, omaveloxolone significantly improved neurological function compared to placebo and was generally safe and well tolerated. It represents a potential therapeutic agent in FRDA. This article is protected by copyright. All rights reserved.",2020,Transient reversible increases in aminotransferase levels were observed with omaveloxolone without increases in total bilirubin or other signs of liver injury.,"['patients with FRDA', '155 patients were screened and 103', ""Eligible patients, 16 to 40\u2009years of age with genetically confirmed FRDA and baseline modified Friedreich's Ataxia Rating Scale (mFARS) scores between 20 and 80"", '11 institutions in the United States, Europe, and Australia (NCT02255435, EudraCT2015-002762-23']","['omaveloxolone patients and 42 placebo', 'placebo', 'Omaveloxolone', 'omaveloxolone']","['mFARS scores', 'total bilirubin', 'Safety and Efficacy', 'safety and efficacy', 'Headache, nausea, and fatigue', 'safe and well tolerated', 'mitochondrial function, restores redox balance', 'aminotransferase levels', 'mFARS score', 'neurological function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016719', 'cui_str': ""Friedreich's ataxia""}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016719', 'cui_str': ""Friedreich's ataxia""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}]",155.0,0.684078,Transient reversible increases in aminotransferase levels were observed with omaveloxolone without increases in total bilirubin or other signs of liver injury.,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lynch', 'Affiliation': ""Division of Neurology, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Melanie P', 'Initials': 'MP', 'LastName': 'Chin', 'Affiliation': 'Reata Pharmaceuticals, Dallas, TX, USA.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Delatycki', 'Affiliation': ""Victorian Clinical Genetics Services, Murdoch Children's Research Institute, Parkville, 3052, Victoria, Australia.""}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Subramony', 'Affiliation': 'Department of Neurology, McKnight Brain Institute, University of Florida Health System, Gainesville, FL, USA.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Corti', 'Affiliation': 'Department of Pediatrics, University of Florida Health System, Gainesville, FL, USA.'}, {'ForeName': 'J Chad', 'Initials': 'JC', 'LastName': 'Hoyle', 'Affiliation': 'Department of Neurology, Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Boesch', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck, AU.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Nachbauer', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck, AU.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Mariotti', 'Affiliation': 'IRCCS - Istituto Neurologico Carlo Besta, Milano, Lombardy, IT.'}, {'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Mathews', 'Affiliation': 'Department of Neurology, University of Iowa Carver College of Medicine, Iowa City, IA, USA.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Giunti', 'Affiliation': 'University College London Hospital, Bloomsbury, London, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wilmot', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Zesiewicz', 'Affiliation': 'Department of Neurology, University of South Florida Ataxia Research Center, Tampa, FL, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Perlman', 'Affiliation': 'Department of Neurology, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Angie', 'Initials': 'A', 'LastName': 'Goldsberry', 'Affiliation': 'Reata Pharmaceuticals, Dallas, TX, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': ""O'Grady"", 'Affiliation': 'Reata Pharmaceuticals, Dallas, TX, USA.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Meyer', 'Affiliation': 'Reata Pharmaceuticals, Dallas, TX, USA.'}]",Annals of neurology,['10.1002/ana.25934']
1095,33068056,Targeting the sensory feedback within the swallowing network-Reversing artificially induced pharyngolaryngeal hypesthesia by central and peripheral stimulation strategies.,"Pharyngolaryngeal hypesthesia is a major reason for dysphagia in various neurological diseases. Emerging neuromodulation devices have shown potential to foster dysphagia rehabilitation, but the optimal treatment strategy is unknown. Because functional imaging studies are difficult to conduct in severely ill patients, we induced a virtual sensory lesion in healthy volunteers and evaluated the effects of central and peripheral neurostimulation techniques. In a sham-controlled intervention study with crossover design on 10 participants, we tested the potential of (peripheral) pharyngeal electrical stimulation (PES) and (central) transcranial direct current stimulation (tDCS) to revert the effects of lidocaine-induced pharyngolaryngeal hypesthesia on central sensorimotor processing. Changes were observed during pharyngeal air-pulse stimulation and voluntary swallowing applying magnetoencephalography before and after the interventions. PES induced a significant (p < .05) increase of activation during swallowing in the bihemispheric sensorimotor network in alpha and low gamma frequency ranges, peaking in the right premotor and left primary sensory area, respectively. With pneumatic stimulation, significant activation increase was found after PES in high gamma peaking in the left premotor area. Significant changes of brain activation after tDCS could neither be detected for pneumatic stimulation nor for swallowing. Due to the peripheral cause of dysphagia in this model, PES was able to revert the detrimental effects of reduced sensory input on central processing, whereas tDCS was not. Results may have implications for therapeutic decisions in the clinical context.",2020,"PES induced a significant (p < .05) increase of activation during swallowing in the bihemispheric sensorimotor network in alpha and low gamma frequency ranges, peaking in the right premotor and left primary sensory area, respectively.","['severely ill patients', '10 participants', 'healthy volunteers']","['lidocaine-induced pharyngolaryngeal hypesthesia', 'peripheral) pharyngeal electrical stimulation (PES) and (central) transcranial direct current stimulation (tDCS']",['brain activation'],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}]",10.0,0.0267589,"PES induced a significant (p < .05) increase of activation during swallowing in the bihemispheric sensorimotor network in alpha and low gamma frequency ranges, peaking in the right premotor and left primary sensory area, respectively.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Muhle', 'Affiliation': 'Department of Neurology with Institute of Translational Neurology, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Bendix', 'Initials': 'B', 'LastName': 'Labeit', 'Affiliation': 'Department of Neurology with Institute of Translational Neurology, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wollbrink', 'Affiliation': 'Institute for Biomagnetism and Biosignalanalysis, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Claus', 'Affiliation': 'Department of Neurology with Institute of Translational Neurology, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Warnecke', 'Affiliation': 'Department of Neurology with Institute of Translational Neurology, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Carsten H', 'Initials': 'CH', 'LastName': 'Wolters', 'Affiliation': 'Institute for Biomagnetism and Biosignalanalysis, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Gross', 'Affiliation': 'Institute for Biomagnetism and Biosignalanalysis, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Dziewas', 'Affiliation': 'Department of Neurology with Institute of Translational Neurology, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Suntrup-Krueger', 'Affiliation': 'Department of Neurology with Institute of Translational Neurology, University Hospital Muenster, Muenster, Germany.'}]",Human brain mapping,['10.1002/hbm.25233']
1096,33068100,Time-efficient physical activity interventions to reduce blood pressure in older adults: a randomised controlled trial.,"BACKGROUND


Hypertension is a risk factor for both cardiovascular and cerebrovascular disease, with an increasing incidence with advancing patient age. Exercise interventions have the potential to reduce blood pressure in older adults, however, rates of exercise uptake and adherence are low, with 'lack of time' a commonly cited reason. As such, there remains the need for time-efficient physical activity interventions to reduce blood pressure in older adults.
OBJECTIVE


To compare the effect of three, novel time-efficient physical activity interventions on resting blood pressure in older adults.
METHODS


Forty-eight, healthy, community-dwelling older adults (mean age: 71 years) were recruited to a 6-week randomised control trial. Resting blood pressure was measured before and after one of three supervised, time-efficient interventions: high-intensity interval training (HIIT) on a cycle ergometer; isometric handgrip training (IHG); unilateral, upper limb remote ischaemic preconditioning (RIPC) or non-intervention control.
RESULTS


Both HIIT and IHG led to a statistically significant reduction in resting systolic blood pressure (SBP) of 9 mmHg, with no significant change in the RIPC or control groups. There was no change in diastolic blood pressure or pulse pressure in any group.
CONCLUSIONS


Supervised HIIT or IHG using the protocols described in this study can lead to statistically significant and clinically relevant reductions in resting SBP in healthy older adults in just 6 weeks.",2020,"Both HIIT and IHG led to a statistically significant reduction in resting systolic blood pressure (SBP) of 9 mmHg, with no significant change in the RIPC or control groups.","['older adults', 'Forty-eight, healthy, community-dwelling older adults (mean age: 71\xa0years', 'healthy older adults']","['novel time-efficient physical activity interventions', 'intensity interval training (HIIT) on a cycle ergometer; isometric handgrip training (IHG); unilateral, upper limb remote ischaemic preconditioning (RIPC) or non-intervention control', 'Exercise interventions', 'Time-efficient physical activity interventions']","['blood pressure', 'resting systolic blood pressure (SBP', 'Resting blood pressure', 'diastolic blood pressure or pulse pressure']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442799', 'cui_str': 'Efficient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}]",,0.0348103,"Both HIIT and IHG led to a statistically significant reduction in resting systolic blood pressure (SBP) of 9 mmHg, with no significant change in the RIPC or control groups.","[{'ForeName': 'Philip J J', 'Initials': 'PJJ', 'LastName': 'Herrod', 'Affiliation': 'Medical Research Council-Versus Arthritis Centre for Musculoskeletal Ageing Research, and NIHR Nottingham Biomedical Research Centre, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}, {'ForeName': 'Jonathan N', 'Initials': 'JN', 'LastName': 'Lund', 'Affiliation': 'Medical Research Council-Versus Arthritis Centre for Musculoskeletal Ageing Research, and NIHR Nottingham Biomedical Research Centre, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}, {'ForeName': 'Bethan E', 'Initials': 'BE', 'LastName': 'Phillips', 'Affiliation': 'Medical Research Council-Versus Arthritis Centre for Musculoskeletal Ageing Research, and NIHR Nottingham Biomedical Research Centre, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}]",Age and ageing,['10.1093/ageing/afaa211']
1097,33068157,Six months vitamin K treatment does not affect systemic arterial calcification or bone mineral density in diabetes mellitus 2.,"PURPOSE


Vitamin K-dependent proteins are involved in (patho)physiological calcification of the vasculature and the bones. Type 2 diabetes mellitus (DM2) is associated with increased arterial calcification and increased fractures. This study investigates the effect of 6 months vitamin K2 supplementation on systemic arterial calcification and bone mineral density (BMD) in DM2 patients with a history of cardiovascular disease (CVD).
METHODS


In this pre-specified, post hoc analysis of a double-blind, randomized, controlled clinical trial, patients with DM2 and CVD were randomized to a daily, oral dose of 360 µg vitamin K2 or placebo for 6 months. CT scans were made at baseline and follow-up. Arterial calcification mass was quantified in several large arterial beds and a total arterial calcification mass score was calculated. BMD was assessed in all non-fractured thoracic and lumbar vertebrae.
RESULTS


68 participants were randomized, 35 to vitamin K2 (33 completed follow-up) and 33 to placebo (27 completed follow-up). The vitamin K group had higher arterial calcification mass at baseline [median (IQR): 1694 (812-3584) vs 1182 (235-2445)] for the total arterial calcification mass). Six months vitamin K supplementation did not reduce arterial calcification progression (β [95% CI]: - 0.02 [- 0.10; 0.06] for the total arterial calcification mass) or slow BMD decline (β [95% CI]: - 2.06 [- 11.26; 7.30] Hounsfield units for all vertebrae) when compared to placebo.
CONCLUSION


Six months vitamin K supplementation did not halt progression of arterial calcification or decline of BMD in patients with DM2 and CVD. Future clinical trials may want to pre-select patients with very low vitamin K status and longer follow-up time might be warranted. This trial was registered at clinicaltrials.gov as NCT02839044.",2020,Six months vitamin K supplementation did not reduce arterial calcification progression (β [95% CI]: - 0.02,"['68 participants were randomized, 35 to', 'patients with DM2 and CVD', 'DM2 patients with a history of cardiovascular disease (CVD', 'Type 2 diabetes mellitus (DM2']","['vitamin K2 or placebo', 'vitamin K2', 'vitamin K', 'vitamin K supplementation', 'placebo', 'vitamin K treatment', 'vitamin K2 supplementation']","['systemic arterial calcification or bone mineral density', 'systemic arterial calcification and bone mineral density (BMD', 'arterial calcification and increased fractures', 'arterial calcification mass', 'Arterial calcification mass', 'total arterial calcification mass) or slow BMD decline', 'progression of arterial calcification or decline of BMD', 'arterial calcification progression', 'BMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1300562', 'cui_str': 'dm2'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0455539', 'cui_str': 'H/O: cardiovascular disease'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1168153', 'cui_str': 'Arterial calcification'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",68.0,0.769215,Six months vitamin K supplementation did not reduce arterial calcification progression (β [95% CI]: - 0.02,"[{'ForeName': 'Jonas W', 'Initials': 'JW', 'LastName': 'Bartstra', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Fieke', 'Initials': 'F', 'LastName': 'Draaisma', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Sabine R', 'Initials': 'SR', 'LastName': 'Zwakenberg', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Nikolas', 'Initials': 'N', 'LastName': 'Lessmann', 'Affiliation': 'Diagnostic Image Analysis Group, Department of Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Jelmer M', 'Initials': 'JM', 'LastName': 'Wolterink', 'Affiliation': 'Department of Applied Mathematics, Technical Medical Centre, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Yvonne T', 'Initials': 'YT', 'LastName': 'van der Schouw', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Pim A', 'Initials': 'PA', 'LastName': 'de Jong', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Joline W J', 'Initials': 'JWJ', 'LastName': 'Beulens', 'Affiliation': 'Department of Epidemiology and Data Science, Amsterdam University Medical Centers, Location VUmc, Amsterdam Public Health and Amsterdam Cardiovascular Sciences Research Institutes, Postbox 7057, 1007 MB, Amsterdam, The Netherlands. j.beulens@amsterdamumc.nl.'}]",European journal of nutrition,['10.1007/s00394-020-02412-z']
1098,33068165,Higher rate of complications with uncemented compared to cemented total hip arthroplasty for displaced intracapsular hip fractures: A randomised controlled trial of 50 patients.,"BACKGROUND


The primary aim of this study was to compare the functional outcome of uncemented with cemented total hip arthroplasty (THA) for displaced intracapsular hip fractures. The secondary aims were to assess length of surgery, blood loss, complications and revision rate between the two groups.
METHODS


A prospective double-blind randomised control trial was conducted. Fifty patients with an intracapsular hip fracture meeting the inclusion criteria were randomised to either an uncemented (n = 25) or cemented (n = 25) THA. There were no differences (p > 0.45) in age, gender, health status or preinjury hip function between the groups. The Oxford hip score (OHS), Harris Hip score (HHS), EuroQol 5-dimensional (EQ5D), timed get up-and-go (TUG), pain and patient satisfaction were used to assess outcome. These were assessed at 4, 12 and 72 months after surgery, apart from the TUG which as only assessed as 6 months.
RESULTS


The study was terminated early due to the significantly (n = 8, p = 0.004) higher rate of intraoperative complications in the uncemented group: three fractures of the proximal femur and five conversions to a cemented acetabular component. There were no significant (p ≥ 0.09) differences in the functional measures (OHS, HSS, EQ5D, TUG and pain) or patient satisfaction between the groups. There was no difference in operative time (p = 0.75) or blood loss (p = 0.66) between the groups. There were two early revisions prior to 3 months post-operatively in the uncemented group and none in the cemented group, but this was not significant (log rank p = 0.16).
CONCLUSION


There was a high rate of intraoperative complications, which may be due to poor bone quality in this patient group. There were no ergonomic or functional advantages demonstrated between uncemented and cemented THA. Cemented THA should remain as the preferred choice for the treatment of intracapsular hip fractures for patients that meet the criteria for this procedure.",2020,There was no difference in operative time (p = 0.75) or blood loss (p = 0.66) between the groups.,"['displaced intracapsular hip fractures', 'Fifty patients with an\xa0intracapsular hip fracture meeting the inclusion criteria were randomised to either an uncemented (n\u2009=\u200925) or cemented (n\u2009=\u200925', '50 patients']","['Cemented THA', 'cemented total hip arthroplasty', 'uncemented with cemented total hip arthroplasty (THA']","['length of surgery, blood loss, complications and revision rate', 'operative time', 'Oxford hip score (OHS), Harris Hip score (HHS), EuroQol 5-dimensional', 'ergonomic or functional advantages', 'EQ5D), timed get up-and-go (TUG), pain and patient satisfaction', 'functional measures (OHS, HSS, EQ5D, TUG and pain) or patient satisfaction', 'rate of intraoperative complications', 'blood loss']","[{'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}]","[{'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1998079', 'cui_str': 'Oxford hip score'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018522', 'cui_str': 'Hallermann-Streiff syndrome'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}]",50.0,0.0973662,There was no difference in operative time (p = 0.75) or blood loss (p = 0.66) between the groups.,"[{'ForeName': 'N D', 'Initials': 'ND', 'LastName': 'Clement', 'Affiliation': 'Department of Orthopaedics and Trauma, The Royal Infirmary of Edinburgh, Little France, Edinburgh, EH16 4SA, UK. nickclement@doctors.org.uk.'}, {'ForeName': 'Marietta', 'Initials': 'M', 'LastName': 'van der Linden', 'Affiliation': 'Centre for Health Activity and Rehabilitation Research, Queen Margaret University, Edinburgh, EH21 6UU, UK.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Keating', 'Affiliation': 'Department of Orthopaedics and Trauma, The Royal Infirmary of Edinburgh, Little France, Edinburgh, EH16 4SA, UK.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-020-02808-x']
1099,33068178,Comparison of low-level light therapy and combination therapy of 5% minoxidil in the treatment of female pattern hair loss.,"This study was conducted in order to compare the safety and efficacy of LLLT, 5% minoxidil, and combination therapy in the treatment of FPHL. A randomized controlled trial was developed to study the effect of LLLT on FPHL using a device called iHelmet®, which is equipped with 200 5mW laser diode source (650 nm) arrays. Ninety Ludwig's types II-III FPHL patients were randomly divided into 3 groups: LLLT group (A), 5% minoxidil group (B), and combination group(C). Hair density, hair diameter, and scalp oil-secretion were detected to evaluate the treatment effect. Significant improvement of hair density and hair diameter was observed in all stages of FPHL after treatment. Oil-secretion of the three groups was decreased after treatment. The effectiveness of reducing oil-secretion in LLLT group and combination group was higher than minoxidil group (P < 0.05). For improving hair diameter and hair density, combination group was better than LLLT and minoxidil groups. No side effects were reported. Our study illustrated that LLLT is a safe and effective treatment for FPHL. Besides, LLLT can significantly improve its efficacy when used in combination with 5% minoxidil.",2020,The effectiveness of reducing oil-secretion in LLLT group and combination group was higher than minoxidil group (P < 0.05).,"[""Ninety Ludwig's types II-III FPHL patients"", 'female pattern hair loss']","['LLLT', 'LLLT and minoxidil', 'low-level light therapy and combination therapy of 5% minoxidil', 'minoxidil']","['Hair density, hair diameter, and scalp oil-secretion', 'hair diameter and hair density', 'Oil-secretion', 'hair density and hair diameter', 'safety and efficacy', 'oil-secretion']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0024081', 'cui_str': ""Ludwig's angina""}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0149217,The effectiveness of reducing oil-secretion in LLLT group and combination group was higher than minoxidil group (P < 0.05).,"[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Plastic and Aesthetic Surgery, Nan Fang Hospital of Southern Medical University, 1838 North Guangzhou AV, Guangzhou, 510515, Guangdong, People's Republic of China.""}, {'ForeName': 'Lin-Lang', 'Initials': 'LL', 'LastName': 'Jiang', 'Affiliation': ""Affiliated Hospital of Xiangnan University, Chenzhou, 423099, Hunan Province, People's Republic of China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Department of Plastic and Aesthetic Surgery, Nan Fang Hospital of Southern Medical University, 1838 North Guangzhou AV, Guangzhou, 510515, Guangdong, People's Republic of China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Qu', 'Affiliation': ""Department of Plastic and Aesthetic Surgery, Nan Fang Hospital of Southern Medical University, 1838 North Guangzhou AV, Guangzhou, 510515, Guangdong, People's Republic of China.""}, {'ForeName': 'Zhe-Xiang', 'Initials': 'ZX', 'LastName': 'Fan', 'Affiliation': ""Department of Plastic and Aesthetic Surgery, Nan Fang Hospital of Southern Medical University, 1838 North Guangzhou AV, Guangzhou, 510515, Guangdong, People's Republic of China.""}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': ""Department of Plastic and Aesthetic Surgery, Nan Fang Hospital of Southern Medical University, 1838 North Guangzhou AV, Guangzhou, 510515, Guangdong, People's Republic of China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Miao', 'Affiliation': ""Department of Plastic and Aesthetic Surgery, Nan Fang Hospital of Southern Medical University, 1838 North Guangzhou AV, Guangzhou, 510515, Guangdong, People's Republic of China. miaoyong123@i.smu.edu.cn.""}, {'ForeName': 'Zhi-Qi', 'Initials': 'ZQ', 'LastName': 'Hu', 'Affiliation': ""Department of Plastic and Aesthetic Surgery, Nan Fang Hospital of Southern Medical University, 1838 North Guangzhou AV, Guangzhou, 510515, Guangdong, People's Republic of China. huzhiqidr@163.com.""}]",Lasers in medical science,['10.1007/s10103-020-03157-1']
1100,33068185,Identification of high-risk carotid plaque with MRI-based radiomics and machine learning.,"OBJECTIVES


We sought to build a high-risk plaque MRI-based model (HRPMM) using radiomics features and machine learning for differentiating symptomatic from asymptomatic carotid plaques.
MATERIALS AND METHODS


One hundred sixty-two patients with carotid stenosis were randomly divided into training and test cohorts. Multi-contrast MRI including time of flight (TOF), T1- and T2-weighted imaging, and contrast-enhanced imaging was done. Radiological characteristics of the carotid plaques were recorded and calculated to build a traditional model. After extracting the radiomics features on these images, we constructed HRPMM with least absolute shrinkage and selection operator algorithm in the training cohort and evaluated its performance in the test cohort. A combined model was also built using both the traditional and radiomics features. The performance of all the models in the identification of high-risk carotid plaque was compared.
RESULTS


Intraplaque hemorrhage and lipid-rich necrotic core were independently associated with clinical symptoms and were used to build the traditional model, which achieved an area under the curve (AUC) of 0.825 versus 0.804 in the training and test cohorts. The HRPMM and the combined model achieved an AUC of 0.988 versus 0.984 and of 0.989 versus 0.986 respectively in the two cohorts. Both the radiomics model and combined model outperformed the traditional model, whereas the combined model showed no significant difference with the HRPMM.
CONCLUSIONS


Our MRI-based radiomics model can accurately distinguish symptomatic from asymptomatic carotid plaques. It is superior to the traditional model in the identification of high-risk plaques.
KEY POINTS


• Carotid plaque multi-contrast MRI stores other valuable information to be further exploited by radiomics analysis. • Radiomics analysis can accurately distinguish symptomatic from asymptomatic carotid plaques. • The radiomics model is superior to the traditional model in the identification of high-risk plaques.",2020,"Both the radiomics model and combined model outperformed the traditional model, whereas the combined model showed no significant difference with the HRPMM.
",['One hundred sixty-two patients with carotid stenosis'],"['high-risk plaque MRI-based model (HRPMM) using radiomics features and machine learning', 'MRI-based radiomics and machine learning']","['Radiological characteristics of the carotid plaques', 'time of flight (TOF), T1- and T2-weighted imaging']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007282', 'cui_str': 'Carotid artery stenosis'}]","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]",162.0,0.0279538,"Both the radiomics model and combined model outperformed the traditional model, whereas the combined model showed no significant difference with the HRPMM.
","[{'ForeName': 'Ranying', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Zhongshan Hospital, Fudan University and Shanghai Institute of Medical Imaging, 180 Fenglin Road, Shanghai, 200032, China.'}, {'ForeName': 'Qingwei', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, 145 Middle Shandong Road, Shanghai, China.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Ji', 'Affiliation': 'Department of Radiology, Zhongshan Hospital, Fudan University and Shanghai Institute of Medical Imaging, 180 Fenglin Road, Shanghai, 200032, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Lv', 'Affiliation': 'Department of Radiology, Zhongshan Hospital, Fudan University and Shanghai Institute of Medical Imaging, 180 Fenglin Road, Shanghai, 200032, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Zhongshan Hospital, Fudan University and Shanghai Institute of Medical Imaging, 180 Fenglin Road, Shanghai, 200032, China.'}, {'ForeName': 'Caixia', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'MR Application Development, Siemens Shenzhen Magnetic Resonance Ltd., Gaoxin C. Ave, 2nd, Hi-Tech Industrial Park, Shenzhen, 518057, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Radiology, Zhongshan Hospital, Fudan University and Shanghai Institute of Medical Imaging, 180 Fenglin Road, Shanghai, 200032, China. lin.jiang@zs-hospital.sh.cn.'}]",European radiology,['10.1007/s00330-020-07361-z']
1101,33068301,Saxagliptin and Vildagliptin Lowered Albuminuria in Patients with Diabetes and Hypertension Independent on Glycemic Control.,"BACKGROUND


Preclinical data illustrated that the dipeptidyl peptidase-4(DPP-4) inhibitors did lower urinary albumin excretion in diabetes-induced rats. We evaluated the effects of saxagliptin and vildagliptin on albuminuria in patients with diabetic nephropathy on top of renin-angiotensin-aldosterone system (RAAS) blockade therapy.
METHODS


This study included 120 patients with type 2 diabetes (T2D), hypertension and prevalent albuminuria [defined as urine albumin-to-creatinine ratio (UACR) 30-3000mg/g creatinine] on stable dose of olmesartan as a standard RAAS blocker for diabetic nephropathy. Patients were assigned to receive either of saxagliptin 5mg/day (n=40), vildagliptin 100mg/day (n=40), or traditional antidiabetic therapy as control patients (n=40) for 12 weeks.
RESULTS


Each of saxagliptin and vildagliptin significantly reduced albuminuria after 12 weeks, with mean percentage changes (%) of -57.9% [95% confidence interval (CI) -66.1to -49.8], and -55.2% (95% CI -64.9 to -45.4); p <0.001, respectively, compared to the control group. Significantly, saxagliptin shifted higher proportions of patients towards lower albuminuria categories (p <0.001) compared to vildagliptin despite similar UACR rate of changes. Results of binary logistic models confirmed that the change in UACR due to saxagliptin was independent on changes in systolic blood pressure (SBP), glycated hemoglobin (HbA 1c  ), estimated glomerular filtration rate (eGFR), or body weight (overall regression: p=0.002, R 2  =0.398) versus control. Likewise, vildagliptin reduced UACR independently on other confounders (overall regression: p =0.002, R 2  =0.388). Furthermore, no significant correlation was observed between the change in UACR and changes in HbA1c, SBP or eGFR with either saxagliptin or vildagliptin (Pearson coefficients: 0.203, 0.143, -0.190; p>0.05, and 0.003, 0.241, 0.019; p>0.05, respectively).
CONCLUSIONS


DPP-4 inhibitors, saxagliptin and vildagliptin, resulted in substantial reductions in albuminuria in patients with T2D and hypertension on top of RAAS blockade after short term therapy independently on glycemic or hemodynamic changes. Saxagliptin was superior to vildagliptin in albuminuria-categorical shifting.",2020,"Significantly, saxagliptin shifted higher proportions of patients towards lower albuminuria categories (p <0.001) compared to vildagliptin despite similar UACR rate of changes.","['patients with diabetic nephropathy on top of renin-angiotensin-aldosterone system (RAAS) blockade therapy', '120 patients with type 2 diabetes (T2D), hypertension and prevalent albuminuria [defined as urine albumin-to-creatinine ratio (UACR', 'diabetes-induced rats', 'patients with T2D and hypertension', 'diabetic nephropathy', 'Patients with Diabetes and Hypertension Independent on Glycemic Control']","['olmesartan', 'Saxagliptin and Vildagliptin', 'RAAS blocker', 'vildagliptin', 'saxagliptin and vildagliptin', 'Saxagliptin', 'saxagliptin', 'traditional antidiabetic therapy']","['albuminuria categories', 'systolic blood pressure (SBP), glycated hemoglobin (HbA 1c  ), estimated glomerular filtration rate (eGFR), or body weight', 'urinary albumin excretion', 'albuminuria', 'UACR and changes in HbA1c, SBP or eGFR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1098320', 'cui_str': 'olmesartan'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]",120.0,0.0219221,"Significantly, saxagliptin shifted higher proportions of patients towards lower albuminuria categories (p <0.001) compared to vildagliptin despite similar UACR rate of changes.","[{'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Mohsen', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Elberry', 'Affiliation': 'Clinical Pharmacology Department, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Mohamed Rabea', 'Affiliation': 'Internal Medicine and Nephrology Department, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Mohamed Ea', 'Initials': 'ME', 'LastName': 'Abdelrahim', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Raghda R S', 'Initials': 'RRS', 'LastName': 'Hussein', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}]",International journal of clinical practice,['10.1111/ijcp.13769']
1102,33068342,[Acupuncture technique of  Jingou Diaoyu  combined with speech rehabilitation training for post-stroke motor aphasia].,"OBJECTIVE


To compare the clinical efficacy of the acupuncture technique of  Jingou Diaoyu  combined with speech rehabilitation training and speech rehabilitation training alone for post-stroke motor aphasia.
METHODS


A total of 70 patients with post-stroke motor aphasia were randomly divided into an observation group and a control group, 35 cases in each group. The patients in the control group were treated with basic treatment and speech rehabilitation training; on the basis of the control group, the patients in the observation group were treated with the acupuncture technique of  Jingou Diaoyu  at Yamen (GV 15), Jinjin (EX-HN 12), Yuye (EX-HN 13), and Hegu (LI 4) etc., once a day, 6 days per week, for a total of 4 weeks. The speech function score, aphasia grade, daily life speech ability score of the two groups before and after treatment were observed, and the clinical efficacy was evaluated.
RESULTS


The total effective rate was 94.3% (33/35) in the observation group, which was superior to 80.0% (28/35) in the control group ( P <0.05). In addition to listening comprehension, each score of speech function in the two groups was significantly increased after treatment ( P <0.05), and the increasing in the observation group was greater than that in the control group ( P <0.05). After treatment, the aphasia grade of the two groups were improved ( P <0.05), and the aphasia grade in the observation group was significantly better than that in the control group ( P <0.05). After treatment, the scores of daily life speech ability in the two groups were significantly improved ( P <0.05), and the increasing in the observation group was greater than that in the control group ( P <0.05).
CONCLUSION


The acupuncture technique of  Jingou Diaoyu  combined with speech rehabilitation training could improve the speech function of patients with post-stroke motor aphasia, and its curative effect is superior to the speech rehabilitation training alone.",2020,"After treatment, the scores of daily life speech ability in the two groups were significantly improved ( P <0.05), and the increasing in the observation group was greater than that in the control group ( P <0.05).
","['70 patients with post-stroke motor aphasia', 'patients with post-stroke motor aphasia', 'post-stroke motor aphasia']","['acupuncture technique of  Jingou Diaoyu  at Yamen (GV 15), Jinjin (EX-HN 12), Yuye (EX-HN 13), and Hegu', 'basic treatment and speech rehabilitation training', 'Acupuncture technique of  Jingou Diaoyu  combined with speech rehabilitation training', 'acupuncture technique of  Jingou Diaoyu  combined with speech rehabilitation training and speech rehabilitation training alone', 'speech rehabilitation training']","['total effective rate', 'clinical efficacy', 'scores of daily life speech ability', 'score of speech function', 'speech function score, aphasia grade, daily life speech ability score', 'speech function', 'aphasia grade']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0003550', 'cui_str': 'Motor aphasia'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0919925', 'cui_str': 'Speech rehabilitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",70.0,0.0230044,"After treatment, the scores of daily life speech ability in the two groups were significantly improved ( P <0.05), and the increasing in the observation group was greater than that in the control group ( P <0.05).
","[{'ForeName': 'Chao-Zhan', 'Initials': 'CZ', 'LastName': 'Ren', 'Affiliation': 'First Department of Acupuncture and Moxibustion, Gansu Hospital of TCM, Lanzhou 730050, China.'}, {'ForeName': 'Xi-Yan', 'Initials': 'XY', 'LastName': 'Lv', 'Affiliation': 'Department of Rehabilitation Medicine, Gansu Hospital of TCM, Lanzhou 730050, China.'}, {'ForeName': 'Xi-Juan', 'Initials': 'XJ', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Therapy, Gansu Rehabilitation Center Hospital.'}, {'ForeName': 'Xing-Hua', 'Initials': 'XH', 'LastName': 'Zhang', 'Affiliation': 'First Department of Acupuncture and Moxibustion, Gansu Hospital of TCM, Lanzhou 730050, China.'}, {'ForeName': 'Hong-Tao', 'Initials': 'HT', 'LastName': 'Zhang', 'Affiliation': 'First Department of Acupuncture and Moxibustion, Gansu Hospital of TCM, Lanzhou 730050, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190811-k0002']
1103,33068343,[Impact of abdominal moxibustion in a period of day from 7 am to 9 am on improvement in post-stroke lower limb spasticity and muscle architecture parameter].,"OBJECTIVE


To compare the therapeutic effect on post-stroke lower limb spasticity between the combined treatment of abdominal moxibustion from 7 am to 9 am and rehabilitation training and the simple rehabilitation training.
METHODS


A total of 100 patients with post-stroke lower limb spasticity were randomized into an observation group (50 cases, 3 cases dropped off) and a control group (50 cases, 4 cases dropped off ). In the control group, the basic treatment of internal medicine and rehabilitation training of the limbs were adopted. In the observation group, on the basis of the treatment in the control group, at the time zone from 7 am to 9 am, moxibustion on the abdomen with ""eight-trigram"" moxa box [the central moxa box accurately facing Shenque (CV 8)] was given, lasting for 2 h, once every two days. Both groups were treated for 6 weeks. Separately, before and after treatment, the score of Fugl-Meyer assessment of the lower extremity (FMA-LE) and the grade of modified Ashworth scale (MAS) of ankle joint were evaluated on the affected side in patients of the two groups. Muscle skeleton ultrasound (MSUS) was adopted to determine the first layer muscle thickness (MT) anterior to the tibia, the number of pennation angle (PA) and the length of muscle fibers in the medial head of gastrocnemius muscle on the affected side. Besides, after treatment, the therapeutic effect was evaluated in the two groups.
RESULTS


After treatment, the score of FMA-LE and the grade of MAS of ankle joint on the affected side were both improved as compared with those before treatment in patients of the two groups ( P <0.01,  P <0.05). The improvements in the observation group were better than those in the control group ( P <0.01,  P <0.05). After treatment, MT anterior to the tibia, the number of PA and the length of muscle fibers in the medial head of gastrocnemius muscle on the affected side were all increased as compared with before treatment in patients of the two groups ( P <0.01). The increase degree in the observation group was larger than that in the control group ( P <0.01). The total effective rate was 93.6% (44/47) in the observation group, better than 80.4% (37/46) in the control group ( P <0.05).
CONCLUSION


The combined treatment of abdominal moxibustion from 7 am to 9 am and rehabilitation training effectively relieves post-stroke lower limb spasticity and improves the limb functions and muscle structure. The total effective rate of this combined treatment is better than that of simple rehabilitation training.",2020,"The improvements in the observation group were better than those in the control group ( P <0.01,  P <0.05).",['100 patients with post-stroke lower limb spasticity'],"['Muscle skeleton ultrasound (MSUS', 'abdominal moxibustion', 'abdominal moxibustion from 7 am to 9 am and rehabilitation training and the simple rehabilitation training', 'abdominal moxibustion from 7 am to 9 am and rehabilitation training']","['limb functions and muscle structure', 'therapeutic effect', 'total effective rate', 'score of Fugl-Meyer assessment of the lower extremity (FMA-LE) and the grade of modified Ashworth scale (MAS) of ankle joint', 'score of FMA-LE and the grade of MAS of ankle joint', 'number of PA and the length of muscle fibers in the medial head of gastrocnemius muscle on the affected side']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1271100', 'cui_str': 'Lower limb spasticity'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205352', 'cui_str': 'Simple'}]","[{'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1305763', 'cui_str': 'Muscle structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0224460', 'cui_str': 'Structure of medial head of gastrocnemius muscle'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}]",100.0,0.0224451,"The improvements in the observation group were better than those in the control group ( P <0.01,  P <0.05).","[{'ForeName': 'Zi-Han', 'Initials': 'ZH', 'LastName': 'Lin', 'Affiliation': 'Department of Acupuncture-Moxibustion and Rehabilitation, Quanzhou Hospital of TCM Affiliated to Fujian University of TCM, Quanzhou 362000, China.'}, {'ForeName': 'Chuan-Liang', 'Initials': 'CL', 'LastName': 'Ruan', 'Affiliation': 'Department of Acupuncture-Moxibustion and Rehabilitation, Quanzhou Hospital of TCM Affiliated to Fujian University of TCM, Quanzhou 362000, China.'}, {'ForeName': 'Wen-Qiang', 'Initials': 'WQ', 'LastName': 'Zhou', 'Affiliation': 'Department of Acupuncture-Moxibustion and Rehabilitation, Quanzhou Hospital of TCM Affiliated to Fujian University of TCM, Quanzhou 362000, China.'}, {'ForeName': 'Li-Rong', 'Initials': 'LR', 'LastName': 'Zeng', 'Affiliation': 'Department of Acupuncture-Moxibustion and Rehabilitation, Quanzhou Hospital of TCM Affiliated to Fujian University of TCM, Quanzhou 362000, China.'}, {'ForeName': 'Chun-Yan', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture-Moxibustion and Rehabilitation, Quanzhou Hospital of TCM Affiliated to Fujian University of TCM, Quanzhou 362000, China.'}, {'ForeName': 'Ping-Ping', 'Initials': 'PP', 'LastName': 'Zeng', 'Affiliation': 'Department of Acupuncture-Moxibustion and Rehabilitation, Quanzhou Hospital of TCM Affiliated to Fujian University of TCM, Quanzhou 362000, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190904-k0001']
1104,33068344,[Immediate effect of acupuncture and moxibustion at Guanyuan (CV 4) and Zusanli (ST 36) on heart rate variability in patients with  qi  deficiency syndrome].,"OBJECTIVE


To compare the immediate effect of acupuncture and moxibustion at Guanyuan (CV 4) and Zusanli (ST 36) on heart rate variability index in patients with  qi  deficiency syndrome.
METHODS


Ninety patients with  qi  deficiency syndrome were randomly divided into an acupuncture group, a moxibustion group and a blank group, 30 patients in each group. The patients in the acupuncture group were treated with acupuncture at Guanyuan (CV 4) and Zusanli (ST 36) for 15 min; acupuncture was given once. The patients in the moxibustion group were treated with moxibustion with identical acupoints and treatment duration. The patients in the blank group received no intervention. The symptom scores of  qi  deficiency syndrome in each group before and after treatment were recorded. The average heart rate and index of heart rate variability including total power, low frequency (LF), high frequency (HF) and logarithm of LF/HF (log LF/HF) were tested 5 min before treatment, 5 min, 10 min, 15 min into treatment, and 5 min after treatment.
RESULTS


The symptom scores of  qi  deficiency syndrome were reduced in the acupuncture group and moxibustion group after treatment ( P <0.05). Compared before treatment, in the acupuncture group, the HF was increased 5 min into treatment ( P <0.05), but was reduced 15 min into treatment and 5 min after treatment ( P <0.05,  P <0.01). The log LF/HF was increased 5 min and 10 min into treatment and 5 min after treatment ( P <0.01). The difference of average heart rate between 5 min before treatment and 5 min after treatment in the acupuncture group was higher than that in the moxibustion group and blank group ( P <0.05), and the difference of log LF/HF was higher than that in the moxibustion group and blank group ( P <0.05,  P <0.01).
CONCLUSION


Acupuncture and moxibustion has immediate effects on heart rate variability in patients with  qi  deficiency syndrome, and the effect of acupuncture is superior to moxibustion, which may be related to the benign regulation of acupuncture on autonomic nervous system.",2020,"Compared before treatment, in the acupuncture group, the HF was increased 5 min into treatment ( P <0.05), but was reduced 15 min into treatment and 5 min after treatment ( P <0.05,  P <0.01).","['patients with  qi  deficiency syndrome', 'Ninety patients with  qi  deficiency syndrome']","['Acupuncture and moxibustion', 'moxibustion with identical acupoints and treatment duration', 'acupuncture and moxibustion at Guanyuan (CV 4) and Zusanli (ST 36', 'acupuncture', 'acupuncture at Guanyuan (CV 4) and Zusanli (ST 36) for 15 min; acupuncture', 'moxibustion group and a blank group']","['log LF/HF', 'symptom scores of  qi  deficiency syndrome', 'average heart rate', 'heart rate variability index', 'average heart rate and index of heart rate variability including total power, low frequency (LF), high frequency (HF) and logarithm of LF/HF', 'HF', 'heart rate variability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]",90.0,0.0477659,"Compared before treatment, in the acupuncture group, the HF was increased 5 min into treatment ( P <0.05), but was reduced 15 min into treatment and 5 min after treatment ( P <0.05,  P <0.01).","[{'ForeName': 'Yan-Juan', 'Initials': 'YJ', 'LastName': 'Song', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}, {'ForeName': 'Feng-Xia', 'Initials': 'FX', 'LastName': 'Liang', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}, {'ForeName': 'Litscher', 'Initials': 'L', 'LastName': 'Gerhard', 'Affiliation': 'Traditional Medicine Research Center, Medical University of Graz, Graz 8036, Austria.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}, {'ForeName': 'Ru-Feng', 'Initials': 'RF', 'LastName': 'Teng', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}, {'ForeName': 'Xiang-Lin', 'Initials': 'XL', 'LastName': 'Chen', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190727-k0003']
1105,33068345,[Scraping on head and face combined with stepping technique of  tuina  along lower limbs for chronic fatigue syndrome].,"OBJECTIVE


To observe the effect of scraping on head and face combined with stepping technique of  tuina  along lower limbs on fatigue symptom and mental state in patients with chronic fatigue syndrome.
METHODS


A total of 100 patients with chronic fatigue syndrome were randomized into an observation group (50 cases, 2 cases dropped off) and a control group (50 cases, 2 cases dropped off). In the control group, oryzanol tablets and compound vitamin B tablets were taken orally, both 2 tablets every time, 3 times every day for 30 days. On the basis of the treatment in the control group, scraping on head and face combined with stepping technique of  tuina  along lower limbs of three  yin  meridians of foot were applied in the observation group, once every 3 days, 10 times were required. Before and after treatment, the scores of fatigue scale-14 (FS-14) and somatic and psychological health report (SPHERE) were observed, and the clinical therapeutic effect was evaluated in the two groups.
RESULTS


After treatment, the scores of FS-14 and SPHERE were reduced in the two groups ( P <0.05), and the changes of those indexes in the observation group were larger than the control group ( P <0.05). The total effective rate was 91.7% (44/48) in the observation group, which was superior to 54.2% (26/48) in the control group ( P <0.05).
CONCLUSION


Scraping on head and face combined with stepping technique of  tuina  along lower limbs can improve fatigue symptom and mental state in patients with chronic fatigue syndrome.",2020,"After treatment, the scores of FS-14 and SPHERE were reduced in the two groups ( P <0.05), and the changes of those indexes in the observation group were larger than the control group ( P <0.05).","['100 patients with chronic fatigue syndrome', 'patients with chronic fatigue syndrome', 'chronic fatigue syndrome']","['stepping technique of  tuina  along lower limbs', 'oryzanol tablets and compound vitamin B tablets', 'Scraping on head and face combined with stepping technique of  tuina']","['total effective rate', 'clinical therapeutic effect', 'fatigue symptom and mental state', 'scores of FS-14 and SPHERE', 'scores of fatigue scale-14 (FS-14) and somatic and psychological health report (SPHERE']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0061081', 'cui_str': 'gamma-oryzanol'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",100.0,0.0230917,"After treatment, the scores of FS-14 and SPHERE were reduced in the two groups ( P <0.05), and the changes of those indexes in the observation group were larger than the control group ( P <0.05).","[{'ForeName': 'Long-Ming', 'Initials': 'LM', 'LastName': 'Lei', 'Affiliation': 'Department of Tuina, First Affiliated Hospital of Guangxi University of CM, Nanning 530023, China.'}, {'ForeName': 'Qiong-Yuan', 'Initials': 'QY', 'LastName': 'Wu', 'Affiliation': 'First Clinical Medical College, Guangxi University of CM.'}, {'ForeName': 'Yu-Feng', 'Initials': 'YF', 'LastName': 'He', 'Affiliation': 'Department of Tuina, First Affiliated Hospital of Guangxi University of CM, Nanning 530023, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190801-k0006']
1106,33068346,"[Acupuncture of ""Zhibian (BL 54) through Shuidao (ST 28)"" for female stress urinary incontinence: a randomized controlled trial].","OBJECTIVE


To observe effect of ""Zhibian (BL 54) through Shuidao (ST 28)"" acupuncture for quality of life of female patients with stress urinary incontinence.
METHODS


A total of 90 female patients were randomly divided into an observation group and a control group, 45 cases in each group. The patients in the observation group were treated with ""Zhibian (BL 54) through Shuidao (ST 28)"" acupuncture method, and the patients in the control group were treated with non-permeable sham acupuncture at Zhibian (BL 54). The needles were retained for 30 min in both groups, once a day, and the treatment was totally given 10 times. The score of urinary incontinence quality of life questionnaire (I-QOL) was recorded before and after treatment and during the follow-up 1 month after treatment in the two groups, and the 1 h urine pad test and the 72 h urination diary card were used to evaluate the 1 h urine leakage and the 24 h urine leakage frequency of the two groups.
RESULTS


After treatment and during follow-up, the I-QOL scores in the observation group were higher than those before treatment ( P <0.05), and were higher than those in the control group ( P <0.05). After treatment and during follow-up, the 1 h urine leakage and the 24 h urine leakage frequency in the observation group were lower than those before treatment ( P <0.05), and less than those in the control group ( P <0.05).
CONCLUSION


Acupuncture of ""Zhibian (BL 54) through Shuidao (ST 28)"" can improve the quality of life of female patients with stress urinary incontinence, and improve the volume and frequency of urine leakage.",2020,"After treatment and during follow-up, the I-QOL scores in the observation group were higher than those before treatment ( P <0.05), and were higher than those in the control group ( P <0.05).","['female patients with stress urinary incontinence', 'female stress urinary incontinence', '90 female patients']","['Acupuncture of ""Zhibian (BL 54) through Shuidao (ST 28', 'non-permeable sham acupuncture', 'Zhibian (BL 54) through Shuidao (ST 28)"" acupuncture', 'Zhibian (BL 54) through Shuidao (ST 28)"" acupuncture method']","['quality of life', 'QOL scores', 'score of urinary incontinence quality of life questionnaire (I-QOL', 'urine leakage frequency']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0332242', 'cui_str': 'Non-permeable'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0152245', 'cui_str': 'Extravasation of urine'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",90.0,0.0210558,"After treatment and during follow-up, the I-QOL scores in the observation group were higher than those before treatment ( P <0.05), and were higher than those in the control group ( P <0.05).","[{'ForeName': 'Hai-Jun', 'Initials': 'HJ', 'LastName': 'Wang', 'Affiliation': 'Third Clinical College of Shanxi University of CM, Jinzhong 030619, China.'}, {'ForeName': 'Yu-Xia', 'Initials': 'YX', 'LastName': 'Cao', 'Affiliation': 'Third Department of Acupuncture and Moxibustion, Acupuncture Hospital of Shanxi Province.'}, {'ForeName': 'Jun-Qiang', 'Initials': 'JQ', 'LastName': 'Ji', 'Affiliation': 'Department of Neurology, Shanxi Province Hospital of Integrated Traditional and Western Medcine.'}, {'ForeName': 'Pei-Rui', 'Initials': 'PR', 'LastName': 'Nie', 'Affiliation': 'Third Department of Acupuncture and Moxibustion, Acupuncture Hospital of Shanxi Province.'}, {'ForeName': 'Jian-Chao', 'Initials': 'JC', 'LastName': 'Wang', 'Affiliation': 'Third Department of Acupuncture and Moxibustion, Acupuncture Hospital of Shanxi Province.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Chen', 'Affiliation': 'Third Department of Acupuncture and Moxibustion, Acupuncture Hospital of Shanxi Province.'}, {'ForeName': 'Rang-Qian', 'Initials': 'RQ', 'LastName': 'Li', 'Affiliation': 'Third Department of Acupuncture and Moxibustion, Acupuncture Hospital of Shanxi Province.'}, {'ForeName': 'Xiao-Ying', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': 'Third Department of Acupuncture and Moxibustion, Acupuncture Hospital of Shanxi Province.'}, {'ForeName': 'Lai-Xi', 'Initials': 'LX', 'LastName': 'Ji', 'Affiliation': 'Third Clinical College of Shanxi University of CM, Jinzhong 030619, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20200410-k0005']
1107,33068347,[Medicated plaster at Dazhui (GV 14) for preventing perioperative hypothermia in patients undergoing PKRP and ureteroscopic laser lithotripsy].,"OBJECTIVE


To observe the preventive effect of medicated plaster at Dazhui (GV 14) on preventing perioperative hypothermia in patients undergoing plasmakinetic resection of prostate (PKRP) and ureteroscopic laser lithotripsy.
METHODS


A total of 300 patients with ASA gradeⅠorⅡreceiving ureteroscopic laser lithotripsy or PKRP under total intravenous anesthesia (TIVA) were randomly divided into an observation group and a control group, 150 cases in each group. The patients in the control group received routine heat preservation measures, while on the basis of the control group, the patients in the observation group were treated with medicated plaster at Dazhui (GV 14) 30 min before operation. The temperature (ear temperature), mean arterial pressure (MAP), heart rate and blood oxygen saturation (SpO 2 ) at each time point (resting state before operation, 5, 10 min into operation, at the end of operation, 5 and 10 min after operation) were recorded; the number of hypothermia, the classification of postoperative shivering degree, operation time, propofol dosage, intraoperative infusion volume and intraoperative flushing fluid volume were recorded.
RESULTS


The temperature at 5 and 10 min into operation as well as at the end of operation in the two groups was all lower than that before operation and at previous time point ( P <0.01). The temperature at 5 and 10 min after operation in the two groups was all higher than that at previous time point ( P <0.01), but still lower than that before operation ( P <0.01). The temperature at 10 min into operation, at the end of operation, 5 and 10 min after operation in the observation group was higher than that in the control group ( P <0.01,  P <0.05). The total incidence rate of hypothermia in the observation group was 2.0% (3/150), which was significantly lower than 13.3% (20/150) in the control group ( P <0.01). The total incidence rate of shivering was 18.0% (27/150) in the observation group and 28.7% (43/150) in the control group ( P >0.05).
CONCLUSION


The medicated plaster at Dazhui (GV 14) can effectively prevent perioperative hypothermia and improve comfort in patients undergoing PKRP and ureteroscopic laser lithotripsy.",2020,The medicated plaster at Dazhui (GV 14) can effectively prevent perioperative hypothermia and improve comfort in patients undergoing PKRP and ureteroscopic laser lithotripsy.,"['300 patients with ASA gradeⅠorⅡreceiving ureteroscopic laser lithotripsy or PKRP under total intravenous anesthesia (TIVA', 'patients undergoing PKRP and', 'patients undergoing PKRP and ureteroscopic laser lithotripsy', 'patients undergoing plasmakinetic resection of prostate (PKRP) and ureteroscopic laser lithotripsy']","['Medicated plaster at Dazhui (GV 14', 'medicated plaster at Dazhui (GV 14', 'routine heat preservation measures', 'ureteroscopic laser lithotripsy', 'medicated plaster at Dazhui (GV 14) 30 min before operation']","['temperature (ear temperature), mean arterial pressure (MAP), heart rate and blood oxygen saturation (SpO 2 ) at each time point (resting state before operation, 5, 10 min into operation', 'total incidence rate of shivering', 'total incidence rate of hypothermia', 'perioperative hypothermia', 'number of hypothermia, the classification of postoperative shivering degree, operation time, propofol dosage, intraoperative infusion volume and intraoperative flushing fluid volume']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}]","[{'cui': 'C0460977', 'cui_str': 'Plasters'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1736186', 'cui_str': 'Postoperative shivering'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}, {'cui': 'C0449971', 'cui_str': 'Volume of fluid used'}]",300.0,0.0127513,The medicated plaster at Dazhui (GV 14) can effectively prevent perioperative hypothermia and improve comfort in patients undergoing PKRP and ureteroscopic laser lithotripsy.,"[{'ForeName': 'Gui-Jie', 'Initials': 'GJ', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of TCM, Shanghai 200021, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of TCM, Shanghai 200021, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of TCM, Shanghai 200021, China.'}, {'ForeName': 'Ya-Lan', 'Initials': 'YL', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of TCM, Shanghai 200021, China.'}, {'ForeName': 'Xiao-Hui', 'Initials': 'XH', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of TCM, Shanghai 200021, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of TCM, Shanghai 200021, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of TCM, Shanghai 200021, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190915-0001']
1108,33068348,[Different needling depth for benign prostatic hyperplasia: a randomized controlled trial].,"OBJECTIVE


To observe the therapeutic effect of different needling depth for benign prostatic hyperplasia.
METHODS


A total of 70 patients with benign prostatic hyperplasia were randomized into an elongated needle group (35 cases, 1 case dropped off) and a filiform needle group (35 cases, 2 cases dropped off). Basic treatment combined with acupuncture were adopted in both groups, acupuncture was applied at Guanyuan (CV 4), Zhongji (CV 3), Shuidao (ST 28), Sanyinjiao (SP 6), Taixi (KI 3), Zhigou (TE 6). In the elongated needle group, acupuncture was performed at Guanyuan (CV 4), Zhongji (CV 3), Shuidao (ST 28) by elongated needle, the needling depth was 60-73 mm. In the filiform needle group, acupuncture was performed at Guanyuan (CV 4), Zhongji (CV 3), Shuidao (ST 28) by filiform needle, the needling depth was 25-30 mm. The treatment was given once a day (except Sunday), 2 weeks as one course, 1 course was required in both groups. Before and after treatment, the international prostate symptom score(IPSS), quality of life (QOL) score and prostate volume were observed in the two groups, and the therapeutic effect was evaluated.
RESULTS


Compared before treatment, the IPSS and QOL scores after 1, 2-week treatment were reduced ( P <0.01), and the IPSS and QOL scores after 2-week treatment were lower than those after 1-week treatment in the two groups ( P <0.01); the IPSS and QOL scores after 2-week treatment in the elongated needle group were lower than the filiform needle group ( P <0.05,  P <0.01). After 2-week treatment, the prostate volume was reduced in the two groups ( P <0.01,  P <0.05). The total effective rate was 91.2% (31/34) in the elongated needle group, which was superior to 72.7% (24/33) in the filiform needle group ( P <0.05).
CONCLUSION


Both elongated needle and filiform needle can improve the symptom and quality of life in patients with benign prostatic hyperplasia, and elongated needle has the better therapeutic effect.",2020,"After 2-week treatment, the prostate volume was reduced in the two groups ( P <0.01,  P <0.05).","['benign prostatic hyperplasia', 'patients with benign prostatic hyperplasia', '70 patients with benign prostatic hyperplasia']","['filiform needle group', 'acupuncture', 'elongated needle and filiform needle']","['international prostate symptom score(IPSS), quality of life (QOL) score and prostate volume', 'total effective rate', 'prostate volume', 'symptom and quality of life', 'IPSS and QOL scores']","[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332226', 'cui_str': 'Filiform'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205166', 'cui_str': 'Long'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}]",70.0,0.0162849,"After 2-week treatment, the prostate volume was reduced in the two groups ( P <0.01,  P <0.05).","[{'ForeName': 'Mu-Fu', 'Initials': 'MF', 'LastName': 'Li', 'Affiliation': 'First Teaching Hospital of Tianjin University of TCM, National Clinical Medical Research Center of Acupuncture-Moxibustion in TCM, Tianjin 300193, China.'}, {'ForeName': 'Jin-Miao', 'Initials': 'JM', 'LastName': 'Lv', 'Affiliation': 'First Teaching Hospital of Tianjin University of TCM, National Clinical Medical Research Center of Acupuncture-Moxibustion in TCM, Tianjin 300193, China.'}, {'ForeName': 'Ling-Fei', 'Initials': 'LF', 'LastName': 'Zhao', 'Affiliation': 'First Teaching Hospital of Tianjin University of TCM, National Clinical Medical Research Center of Acupuncture-Moxibustion in TCM, Tianjin 300193, China.'}, {'ForeName': 'Hong-Yue', 'Initials': 'HY', 'LastName': 'Niu', 'Affiliation': 'First Teaching Hospital of Tianjin University of TCM, National Clinical Medical Research Center of Acupuncture-Moxibustion in TCM, Tianjin 300193, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190923-0001']
1109,33068349,[Acupuncture at Sifeng (EX-UE 10) as adjuvant treatment for pneumonia of phlegm-heat blocking lung type in children: a randomized controlled trial].,"OBJECTIVE


To observe the clinical therapeutic effect of acupuncture at Sifeng (EX-UE 10) as adjuvant treatment for pneumonia of phlegm-heat blocking lung type in children.
METHODS


A total of 80 children with pneumonia of phlegm-heat blocking lung type were randomized into an observation group (40 cases, 1 case dropped off) and a control group (40 cases). In the control group, routine anti-infection and symptomatic and supportive treatment were given. On the basis of the treatment in the control group, acupuncture was applied at Sifeng (EX-UE 10) in the observation group, once every 2 days, 4 times were required. Before and after treatment, the score of clinical symptoms and signs and level of serum hypersensitive C-reactive protein (hs-CRP) were observed in the two groups. The antifebrile time, lung moist rale disappearance time, duration of antibacterial drugs and hospital stays were recorded, and the clinical therapeutic effect was evaluated in the two groups.
RESULTS


After treatment, the scores of clinical symptoms and signs and levels of serum hs-CRP were reduced in the two groups ( P <0.01), and the changes of scores of fever, cough and lung moist rale, secondary symptom score, total score of clinical symptoms and signs and level of serum hs-CRP in the observation group were larger than those in the control group ( P <0.05,  P <0.01). The antifebrile time, lung moist rale disappearance time, duration of antibacterial drugs and hospital stays in the observation group were shorter than those in the control group ( P <0.05). The total effective rate was 87.2% (34/39) in the observation group, which was superior to 65.0% (26/40) in the control group ( P <0.05).
CONCLUSION


Acupuncture at Sifeng (EX-UE 10) as adjuvant treatment can relieve clinical symptoms, shorten duration of antibacterial drugs and hospital stays for children with pneumonia of phlegm-heat blocking lung type.",2020,"After treatment, the scores of clinical symptoms and signs and levels of serum hs-CRP were reduced in the two groups ( P <0.01), and the changes of scores of fever, cough and lung moist rale, secondary symptom score, total score of clinical symptoms and signs and level of serum hs-CRP in the observation group were larger than those in the control group ( P <0.05,  P <0.01).","['pneumonia of phlegm-heat blocking lung type in children', '80 children with pneumonia of phlegm-heat blocking lung type', 'children with pneumonia of phlegm-heat blocking lung type']","['acupuncture at Sifeng (EX-UE 10', 'acupuncture', 'Acupuncture at Sifeng (EX-UE 10']","['changes of scores of fever, cough and lung moist rale, secondary symptom score, total score of clinical symptoms and signs and level of serum hs-CRP', 'total effective rate', 'clinical therapeutic effect', 'score of clinical symptoms and signs and level of serum hypersensitive C-reactive protein (hs-CRP', 'scores of clinical symptoms and signs and levels of serum hs-CRP', 'antifebrile time, lung moist rale disappearance time, duration of antibacterial drugs and hospital stays']","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0225378', 'cui_str': 'Upper respiratory tract mucus'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0858640', 'cui_str': 'Moist rales'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",80.0,0.018728,"After treatment, the scores of clinical symptoms and signs and levels of serum hs-CRP were reduced in the two groups ( P <0.01), and the changes of scores of fever, cough and lung moist rale, secondary symptom score, total score of clinical symptoms and signs and level of serum hs-CRP in the observation group were larger than those in the control group ( P <0.05,  P <0.01).","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qiao', 'Affiliation': 'Second Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing 210023, Jiangsu Province, China; Department of Acupuncture and Moxibustion, Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing 211101, Jiangsu Province.'}, {'ForeName': 'Lan-Ying', 'Initials': 'LY', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Hospital of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Dan-Yan', 'Initials': 'DY', 'LastName': 'Xu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing 211101, Jiangsu Province.'}, {'ForeName': 'Zhi-Qin', 'Initials': 'ZQ', 'LastName': 'Luo', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing 211101, Jiangsu Province.'}, {'ForeName': 'Yi-Huang', 'Initials': 'YH', 'LastName': 'Gu', 'Affiliation': 'Second Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing 210023, Jiangsu Province, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20200302-k0001']
1110,33068350,[Therapeutic effect of acupoint injection as adjuvant treatment on dry eyes of convalescent herpes simplex keratitis].,"OBJECTIVE


To evaluate the clinical effect of acupoint injection of  houttuynia cordata  as the accessory treatment on dry eyes of convalescent herpes simplex keratitis (HSK).
METHODS


A total of 60 patients with dry eyes of convalescent HSK were randomized into an observation group and a control group, 30 cases in each one. In the control group, the artificial tears and anti-inflammatory drugs were combined in treatment. In the observation group, on the base of the treatment as the control group, the acupoint injection of  houttuynia cordata  at Neiqiuhou (Extra) was combined, 3 mL each time, once a day. After consecutive 3 injections, the injection was adjusted to be once every two days, consecutively for 3 times. The treatment for 6 times was as one course and one course of treatment was required. Separately, before treatment and in 7, 15 and 30 days after treatment, the changes of the scores of visual analogue scale (VAS), theresults of SchirmerⅠtest (SⅠT), the tear break-up time (BUT) and the score of corneal fluorescein staining (CFS) were observed and analyzed in the patients of the two groups.
RESULTS


In 7, 15 and 30 days after treatment, VAS scores and CFS scores were all reduced as compared with those before treatment in the patients of the two groups ( P <0.05), and the scores of VAS and CFS in the observation group were lower than those in the control group ( P <0.05). In 7, 15 and 30 days after treatment, the values of SⅠT and BUT were all increased as compared with those before treatment in the patients of the two groups ( P <0.05), and the values in the observation group were higher than the control group in 15 and 30 days after treatment ( P <0.05).
CONCLUSION


Acupoint injection of  houttuynia cordata  promotes corneal epithelial recovery, reduces the discomfort symptoms as well as increases tear secretion and the stability of tear film in dry eyes of convalescent herpes simplex keratitis.",2020,"In 7, 15 and 30 days after treatment, VAS scores and CFS scores were all reduced as compared with those before treatment in the patients of the two groups ( P <0.05), and the scores of VAS and CFS in the observation group were lower than those in the control group ( P <0.05).","['dry eyes of convalescent herpes simplex keratitis', '60 patients with dry eyes of convalescent HSK', 'dry eyes of convalescent herpes simplex keratitis (HSK']","['acupoint injection of  houttuynia cordata  at Neiqiuhou (Extra', 'acupoint injection', 'acupoint injection of  houttuynia cordata']","['scores of VAS and CFS', 'scores of visual analogue scale (VAS), theresults of SchirmerⅠtest (SⅠT), the tear break-up time (BUT) and the score of corneal fluorescein staining (CFS', 'VAS scores and CFS scores', 'values of SⅠT and BUT', 'corneal epithelial recovery']","[{'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0022568', 'cui_str': 'Keratitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1001040', 'cui_str': 'Dokudami'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.0300676,"In 7, 15 and 30 days after treatment, VAS scores and CFS scores were all reduced as compared with those before treatment in the patients of the two groups ( P <0.05), and the scores of VAS and CFS in the observation group were lower than those in the control group ( P <0.05).","[{'ForeName': 'Guang-Hong', 'Initials': 'GH', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Hubei Provincial Hospital of TCM, Wuhan 430061, China; Department of Ophthalmology, Hubei Province Academy of TCM, Wuhan 430074, China.'}, {'ForeName': 'Xiao-Yu', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Hubei Provincial Hospital of TCM, Wuhan 430061, China; Department of Ophthalmology, Hubei Province Academy of TCM, Wuhan 430074, China.'}, {'ForeName': 'Du-Jun', 'Initials': 'DJ', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Hubei Provincial Hospital of TCM, Wuhan 430061, China; Department of Ophthalmology, Hubei Province Academy of TCM, Wuhan 430074, China.'}, {'ForeName': 'Ke-Hu', 'Initials': 'KH', 'LastName': 'Wu', 'Affiliation': 'Department of Ophthalmology, Hubei Provincial Hospital of TCM, Wuhan 430061, China; Department of Ophthalmology, Hubei Province Academy of TCM, Wuhan 430074, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Ophthalmology, Central China Normal University Hospital.'}, {'ForeName': 'Ji-Hong', 'Initials': 'JH', 'LastName': 'Luo', 'Affiliation': 'Department of Ophthalmology, Hubei Provincial Hospital of TCM, Wuhan 430061, China; Department of Ophthalmology, Hubei Province Academy of TCM, Wuhan 430074, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20191230-k0008']
1111,32973120,Socioeconomic Status and Long-term Outcomes in Single Ventricle Heart Disease.,"BACKGROUND


Low socioeconomic status (SES) has emerged as an important risk factor for higher short-term mortality and neurodevelopmental outcomes in children with hypoplastic left heart syndrome and related anomalies; yet little is known about how SES affects these outcomes over the long-term.
METHODS


We linked data from the Single Ventricle Reconstruction trial to US Census Bureau data to analyze the relationship of neighborhood SES tertiles with mortality and transplantation, neurodevelopment, quality of life, and functional status at 5 and 6 years post-Norwood procedure ( N  = 525). Cox proportional hazards regression and linear regression were used to assess the association of SES with mortality and neurodevelopmental outcomes, respectively.
RESULTS


Patients in the lowest SES tertile were more likely to be racial minorities, older at stage 2 and Fontan procedures, and to have more complications and fewer cardiac catheterizations over follow-up (all  P  < .05) compared with patients in higher SES tertiles. Unadjusted mortality was highest for patients in the lowest SES tertile and lowest in the highest tertile (41% vs 29%, respectively; log-rank  P  = .027). Adjustment for patient birth and Norwood factors attenuated these differences slightly ( P  = .055). Patients in the lowest SES tertile reported lower functional status and lower fine motor, problem-solving, adaptive behavior, and communication skills at 6 years (all  P  < .05). These differences persisted after adjustment for baseline and post-Norwood factors. Quality of life did not differ by SES.
CONCLUSIONS


Among patients with hypoplastic left heart syndrome, those with low SES have worse neurodevelopmental and functional status outcomes at 6 years. These differences were not explained by other patient or clinical characteristics.",2020,"Patients in the lowest SES tertile reported lower functional status and lower fine motor, problem-solving, adaptive behavior, and communication skills at 6 years (all  P  < .05).","['children with hypoplastic left heart syndrome and related anomalies', 'patients with hypoplastic left heart syndrome']",[],"['mortality and transplantation, neurodevelopment, quality of life, and functional status', 'cardiac catheterizations', 'neurodevelopmental and functional status outcomes', 'Quality of life', 'functional status and lower fine motor, problem-solving, adaptive behavior, and communication skills', 'Unadjusted mortality']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0225809', 'cui_str': 'Structure of left side of heart'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0085880', 'cui_str': 'Adaptation behavior'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]",,0.0503862,"Patients in the lowest SES tertile reported lower functional status and lower fine motor, problem-solving, adaptive behavior, and communication skills at 6 years (all  P  < .05).","[{'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Bucholz', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Lynn A', 'Initials': 'LA', 'LastName': 'Sleeper', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Caren S', 'Initials': 'CS', 'LastName': 'Goldberg', 'Affiliation': ""Department of Pediatrics, University of Michigan and C.S. Mott Children's Hospital, Ann Arbor, Michigan.""}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Pasquali', 'Affiliation': ""Department of Pediatrics, University of Michigan and C.S. Mott Children's Hospital, Ann Arbor, Michigan.""}, {'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Anderson', 'Affiliation': ""Division of Pediatric Cardiology, Department of Pediatrics, Columbia University Irving Medical Center and NewYork-Presbyterian Morgan Stanley Children's Hospital, New York City, New York.""}, {'ForeName': 'J William', 'Initials': 'JW', 'LastName': 'Gaynor', 'Affiliation': ""Division of Pediatric Cardiac Surgery, Cardiac Center, Children's Hospital of Pennsylvania, Philadelphia, Pennsylvania; and.""}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Cnota', 'Affiliation': ""Department of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Jane W', 'Initials': 'JW', 'LastName': 'Newburger', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts; jane.newburger@cardio.chboston.org.""}]",Pediatrics,['10.1542/peds.2020-1240']
1112,30979941,Sleep Preserves Physiological Arousal in Emotional Memory.,"Traumatic experiences are associated with increased emotional arousal. Overnight consolidation strengthens the episodic content of emotional memories, but it is still unclear how sleep influences the associated arousal response. To investigate this question, we compared the effects of sleep and wake on psychophysiological and subjective reactivity during emotional memory retrieval. Participants provided affective ratings for negative and neutral images while heart rate deceleration (HRD) and skin conductance responses (SCRs) were monitored. Following a 12-hour delay of sleep or wakefulness, participants completed an image recognition task where HRD, SCRs and affective ratings were recorded again. HRD responses to previously-encoded (""old"") negative images were preserved after sleep but diminished after wakefulness. No between-group difference in HRD was observed for novel negative images at recognition, indicating that the effects of sleep for old images were not driven by a generalised overnight increase in visceral activity, or circadian factors. No significant effects of sleep were observed for SCRs or subjective ratings. Our data suggest that cardiac arousal experienced at the time of encoding is sensitive to plasticity-promoting processes during sleep in a similar manner to episodic aspects of emotional memory.",2019,"HRD responses to previously-encoded (""old"") negative images were preserved after sleep but diminished after wakefulness.",[],[],"['emotional arousal', 'HRD, SCRs and affective ratings', 'HRD responses', 'visceral activity, or circadian factors', 'HRD', 'SCRs or subjective ratings', 'affective ratings for negative and neutral images while heart rate deceleration (HRD) and skin conductance responses (SCRs']",[],[],"[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",,0.0369166,"HRD responses to previously-encoded (""old"") negative images were preserved after sleep but diminished after wakefulness.","[{'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Ashton', 'Affiliation': 'Department of Psychology, University of York, Heslington, York, YO10 5DD, UK.'}, {'ForeName': 'Marcus O', 'Initials': 'MO', 'LastName': 'Harrington', 'Affiliation': 'Department of Psychology, University of York, Heslington, York, YO10 5DD, UK.'}, {'ForeName': 'Anna Á Váli', 'Initials': 'AÁV', 'LastName': 'Guttesen', 'Affiliation': 'Department of Psychology, University of York, Heslington, York, YO10 5DD, UK.'}, {'ForeName': 'Anika K', 'Initials': 'AK', 'LastName': 'Smith', 'Affiliation': 'Department of Psychology, University of York, Heslington, York, YO10 5DD, UK.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Cairney', 'Affiliation': 'Department of Psychology, University of York, Heslington, York, YO10 5DD, UK. scott.cairney@york.ac.uk.'}]",Scientific reports,['10.1038/s41598-019-42478-2']
1113,31319018,A mixed methods comparative evaluation of a low cost otoscope (Arclight) with a traditional device in twenty-one clinicians.,,2019,,['twenty-one clinicians'],['low cost otoscope (Arclight'],[],"[{'cui': 'C3715213', 'cui_str': '21'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0182098', 'cui_str': 'Otoscope'}]",[],,0.0231405,,"[{'ForeName': 'Shi Ying', 'Initials': 'SY', 'LastName': 'Hey', 'Affiliation': 'Department of Otolaryngology, NHS Tayside, Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'Joanna C', 'Initials': 'JC', 'LastName': 'Buckley', 'Affiliation': 'Department of Otolaryngology, NHS Tayside, Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'Somayyeh', 'Initials': 'S', 'LastName': 'Shahsavari', 'Affiliation': 'Department of Otolaryngology, NHS Tayside, Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'Obaid', 'Initials': 'O', 'LastName': 'Kousha', 'Affiliation': 'Department of Ophthalmology, NHS Fife, Queen Margaret Hospital, Dunfermline, UK.'}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'Haddow', 'Affiliation': 'Department of Otolaryngology, NHS Tayside, Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blaikie', 'Affiliation': 'Department of Ophthalmology, NHS Fife, Queen Margaret Hospital, Dunfermline, UK.'}, {'ForeName': 'Frank David Lathangie', 'Initials': 'FDL', 'LastName': 'Walker', 'Affiliation': 'Department of Otolaryngology, NHS Fife, Victoria Hospital, Kirkcaldy, UK.'}]",Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery,['10.1111/coa.13403']
1114,31380579,"Sex differences in cardiac function, biomarkers and exercise performance in heart failure with preserved ejection fraction: findings from the RELAX trial.",,2019,,['heart failure with preserved ejection fraction'],[],"['cardiac function, biomarkers and exercise performance']","[{'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}]",[],"[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0452451,,"[{'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Mauricio', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Kershaw V', 'Initials': 'KV', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Agusala', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Kavisha', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Colby', 'Initials': 'C', 'LastName': 'Ayers', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Grodin', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Jarett D', 'Initials': 'JD', 'LastName': 'Berry', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Ambarish', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]",European journal of heart failure,['10.1002/ejhf.1554']
1115,31537327,Left Ventricular Reverse Remodeling in Cardiac Resynchronization Therapy and Long-Term Outcomes.,"OBJECTIVES


The aim of this study was to evaluate the association between improvement in left ventricular end-systolic volume (LVESV) with cardiac resynchronization therapy (CRT) and mortality and whether this relationship was modified by the presence of a left bundle branch block (LBBB) electrocardiographic pattern.
BACKGROUND


Left ventricular reverse remodeling in patients receiving CRT has been shown to predict outcomes. However, the extent to which reverse remodeling contributes to long-term survival is not well understood.
METHODS


Changes in LVESV were assessed in MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) patients receiving CRT with a defibrillator (CRT-D) and echocardiograms available at 1 year (n = 752), stratified by LBBB, relative to long-term all-cause mortality, compared with those with implantable cardioverter-defibrillators (ICDs) only (n = 684).
RESULTS


In patients with LBBB, a reduction in LVESV of >35% (median) translated into significantly lower risk for long-term mortality (hazard ratio [HR]: 0.34; p < 0.001), heart failure (HF) events (HR: 0.21; p < 0.001), and HF or death (HR: 0.27; p < 0.001) compared with patients with ICDs only. Patients with reductions in LVESV ≤35% had a significantly lower risk for HF, and HF or death, and a nonsignificantly lower rate of death compared with those with ICDs only (HR: 0.74; p = 0.13). Risk reduction in HF events was uniform across all LVESV quartiles. In patients without LBBB, there was no survival benefit (HR: 0.68; p = 0.271) despite an LVESV reduction greater than the median (>27.6%). CRT-D patients without LBBB with the least reverse remodeling (quartile 1) had a more than 3-fold increased risk for death compared with those with ICDs only (HR: 3.11; p < 0.001).
CONCLUSIONS


In patients with LBBB, CRT-D-induced reduction in LVESV at 1 year is associated with long-term survival benefit. Despite left ventricular reverse remodeling with CRT-D, there is no survival benefit and potential harm in patients without LBBB.",2019,"Patients with reductions in LVESV ≤35% had a significantly lower risk for HF, and HF or death, and a nonsignificantly lower rate of death compared with those with ICDs only (HR: 0.74; p = 0.13).",['patients receiving'],"['CRT', 'implantable cardioverter-defibrillators (ICDs', 'cardiac resynchronization therapy (CRT', 'Cardiac Resynchronization Therapy']","['Risk reduction in HF events', 'heart failure (HF) events', 'risk for death', 'risk for HF, and HF or death', 'HF or death', 'survival benefit', 'left ventricular end-systolic volume (LVESV', 'rate of death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}]","[{'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}]",,0.101783,"Patients with reductions in LVESV ≤35% had a significantly lower risk for HF, and HF or death, and a nonsignificantly lower rate of death compared with those with ICDs only (HR: 0.74; p = 0.13).","[{'ForeName': 'Syed Y', 'Initials': 'SY', 'LastName': 'Naqvi', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'Jawaid', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Vermilye', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Biering-Sørensen', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Goldenberg', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Zareba', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McNitt', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Bronislava', 'Initials': 'B', 'LastName': 'Polonsky', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Kutyifa', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York. Electronic address: valentina.kutyifa@heart.rochester.edu.'}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2019.07.012']
1116,32024228,How Much Sugar is in My Drink? The Power of Visual Cues.,"Despite widespread attempts to educate consumers about the dangers of sugar, as well as the advent of nutritional labeling, individuals still struggle to make educated decisions about the foods they eat, and/or to use the Nutrition Facts Panel. This study examined the effect of visual aids on judgments of sugar quantity in popular drinks, and choices. 261 volunteers at four different locations evaluated 11 common beverages. Key measures were estimates of sugar in the drinks, nutrition knowledge, and desire to consume them. In the experimental condition, participants viewed beverages along with test tubes filled with the total amount of sugar in each drink; the control condition had no sugar display. Both groups were encouraged to examine the Nutrition Facts Panel when making their evaluations. Correlational analyses revealed that consumers exposed to the visual aid overestimated sugar content and the length of time needed to exercise to burn off the calories; they also had lower intentions to consume any of the beverages. Individuals asserting to use the Nutrition Facts Panel (NFP) in general were also less likely to admit using it in this particular study ( r  = -2,  p  = 0.001). This study suggests that a simple visual aid intervention affected judgments and choices towards curtailing sugar intake. This has implications for labeling format implementation.",2020,Individuals asserting to use the Nutrition Facts Panel (NFP) in general were also less likely to admit using it in this particular study (,['261 volunteers at four different locations evaluated 11 common beverages'],"['Nutrition Facts Panel (NFP', 'visual aids']","['Power of Visual Cues', 'estimates of sugar in the drinks, nutrition knowledge, and desire to consume them']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0042813', 'cui_str': 'Visual Aids'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",261.0,0.0184918,Individuals asserting to use the Nutrition Facts Panel (NFP) in general were also less likely to admit using it in this particular study (,"[{'ForeName': 'Bethany D', 'Initials': 'BD', 'LastName': 'Merillat', 'Affiliation': 'Ohio University, Athens, OH 45701, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'González-Vallejo', 'Affiliation': 'Ohio University, Athens, OH 45701, USA.'}]",Nutrients,['10.3390/nu12020394']
1117,33067287,Treatment success of internet-based vestibular rehabilitation in general practice: development and internal validation of a prediction model.,"OBJECTIVES


To develop and internally validate prediction models to assess treatment success of both stand-alone and blended online vestibular rehabilitation (VR) in patients with chronic vestibular syndrome.
DESIGN


Secondary analysis of a randomised controlled trial.
SETTING


59 general practices in The Netherlands.
PARTICIPANTS


202 adults, aged 50 years and older with a chronic vestibular syndrome who received either stand-alone VR (98) or blended VR (104). Stand-alone VR consisted of a 6-week, internet-based intervention with weekly online sessions and daily exercises. In blended VR, the same intervention was supplemented with physiotherapy support.
MAIN OUTCOME MEASURES


Successful treatment was defined as: clinically relevant improvement of (1) vestibular symptoms (≥3 points improvement Vertigo Symptom Scale-Short Form); (2) vestibular-related disability (>11 points improvement Dizziness Handicap Inventory); and (3) both vestibular symptoms and vestibular-related disability. We assessed performance of the predictive models by applying calibration plots, Hosmer-Lemeshow statistics, area under the receiver operating characteristic curves (AUC) and applied internal validation.
RESULTS


Improvement of vestibular symptoms, vestibular-related disability or both was seen in 121, 81 and 64 participants, respectively. We generated predictive models for each outcome, resulting in different predictors in the final models. Calibration for all models was adequate with non-significant Hosmer-Lemeshow statistics, but the discriminative ability of the final predictive models was poor (AUC 0.54 to 0.61). None of the identified models are therefore suitable for use in daily general practice to predict treatment success of online VR.
CONCLUSION


It is difficult to predict treatment success of internet-based VR and it remains unclear who should be treated with stand-alone VR or blended VR. Because we were unable to develop a useful prediction model, the decision to offer stand-alone or blended VR should for now be based on availability, cost effectiveness and patient preference.
TRIAL REGISTRATION NUMBER


The Netherlands Trial Register NTR5712.",2020,"RESULTS


Improvement of vestibular symptoms, vestibular-related disability or both was seen in 121, 81 and 64 participants, respectively.","['patients with chronic vestibular syndrome', '59 general practices in The Netherlands', '202 adults, aged 50 years and older with a chronic vestibular syndrome who received either stand-alone VR (98) or blended VR (104']","['internet-based vestibular rehabilitation', 'stand-alone and blended online vestibular rehabilitation (VR']","['vestibular symptoms, vestibular-related disability', 'Dizziness Handicap Inventory); and (3) both vestibular symptoms and vestibular-related disability', 'clinically relevant improvement of (1) vestibular symptoms (≥3 points improvement Vertigo Symptom Scale-Short Form); (2) vestibular-related disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",202.0,0.0271032,"RESULTS


Improvement of vestibular symptoms, vestibular-related disability or both was seen in 121, 81 and 64 participants, respectively.","[{'ForeName': 'Vincent A', 'Initials': 'VA', 'LastName': 'van Vugt', 'Affiliation': 'Department of General Practice, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands v.vanvugt@amsterdamumc.nl.'}, {'ForeName': 'Martijn W', 'Initials': 'MW', 'LastName': 'Heymans', 'Affiliation': 'Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'van der Wouden', 'Affiliation': 'Department of General Practice, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Henriëtte E', 'Initials': 'HE', 'LastName': 'van der Horst', 'Affiliation': 'Department of General Practice, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Otto R', 'Initials': 'OR', 'LastName': 'Maarsingh', 'Affiliation': 'Department of General Practice, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2020-038649']
1118,33067293,"School-based, two-arm, parallel, controlled trial of a culturally adapted resilience intervention to improve adolescent mental health in Vietnam: study protocol.","INTRODUCTION


The Resourceful Adolescent Program (RAP) is an evidence-based resilience intervention for adolescents. Operating in a strength-focused paradigm, the programme uses an integration of cognitive behavioural therapy and interpersonal psychotherapy to improve coping skills and build resilience. This study aims to establish whether a culturally and linguistically adapted intervention informed by RAP principles is effective in increasing resilience, enhancing coping skills and preventing symptoms of depression and anxiety.
METHODS AND ANALYSIS


We will translate, back-translate and culturally adapt the RAP for adolescents and training materials for facilitators, and the adapted intervention will be called Happy House. A two-arm parallel controlled trial will be conducted in eight high schools in the north of Vietnam. In each of the selected schools, all students from four randomly selected grade 10 classes (an estimation of about 1204 students) will be invited to participate. The control group will receive the usual curriculum. The intervention group will receive six weekly 90 min school-based group sessions of Happy House in addition to the usual curriculum. The primary outcome, depressive symptoms, will be measured using a locally validated version of the Centre for Epidemiologic Studies Depression Scale Revised. Secondary outcomes are mental well-being, coping self-efficacy, school connectedness, anger management and health risk behaviours. Data will be collected at recruitment, and at two weeks and six months post intervention. Mixed-effect logistic regression for the main outcome and mixed-effect linear and logistic regression models for the secondary outcomes will be conducted to estimate the effects of the intervention on the outcomes.
ETHICS AND DISSEMINATION


This trial has been approved by Monash University Human Research Ethics Committee (No. 21455) and the Institutional Review Board of the Hanoi School of Public Health (488/2019/YTCC-HD3). Dissemination of findings will include peer-reviewed publications, international and national conferences, seminar and media presentations, national policy briefings in Vietnam, local language reports and lay language summaries for participants.
TRIAL REGISTRATION NUMBERS


Registered with the Australian New Zealand Clinical Trials Registry, registration number: ACTRN12620000088943 (3/2/2020).WHO Universal Trial Number: U1111-1246-4079.",2020,"The primary outcome, depressive symptoms, will be measured using a locally validated version of the Centre for Epidemiologic Studies Depression Scale Revised.","['adolescent mental health in Vietnam', 'adolescents', 'eight high schools in the north of Vietnam', 'selected schools, all students from four randomly selected grade 10 classes (an estimation of about 1204 students']","['culturally adapted resilience intervention', 'cognitive behavioural therapy and interpersonal psychotherapy', 'Resourceful Adolescent Program (RAP']","['mental well-being, coping self-efficacy, school connectedness, anger management and health risk behaviours', 'depressive symptoms, will be measured using a locally validated version of the Centre for Epidemiologic Studies Depression Scale Revised']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0557992', 'cui_str': 'Anger management therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]",4.0,0.126691,"The primary outcome, depressive symptoms, will be measured using a locally validated version of the Centre for Epidemiologic Studies Depression Scale Revised.","[{'ForeName': 'Thach', 'Initials': 'T', 'LastName': 'Tran', 'Affiliation': ""Global and Women's Health, Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.""}, {'ForeName': 'Huong Thanh', 'Initials': 'HT', 'LastName': 'Nguyen', 'Affiliation': 'Department of Health Education, Faculty of Social Science, Behavior and Health Education, Hanoi University of Public Health, Hanoi, Vietnam.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Shochet', 'Affiliation': 'School of Psychology and Counselling, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Wurfl', 'Affiliation': 'School of Psychology and Counselling, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Orr', 'Affiliation': 'School of Psychology and Counselling, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Nga', 'Initials': 'N', 'LastName': 'Nguyen', 'Affiliation': 'Department of Health Education, Faculty of Social Science, Behavior and Health Education, Hanoi University of Public Health, Hanoi, Vietnam.'}, {'ForeName': 'Nga', 'Initials': 'N', 'LastName': 'La', 'Affiliation': 'Department of Health Education, Faculty of Social Science, Behavior and Health Education, Hanoi University of Public Health, Hanoi, Vietnam.'}, {'ForeName': 'Hau', 'Initials': 'H', 'LastName': 'Nguyen', 'Affiliation': ""Global and Women's Health, Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.""}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Stocker', 'Affiliation': ""Global and Women's Health, Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.""}, {'ForeName': 'Trang', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': ""Global and Women's Health, Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.""}, {'ForeName': 'Minh', 'Initials': 'M', 'LastName': 'Le', 'Affiliation': ""Global and Women's Health, Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Fisher', 'Affiliation': ""Global and Women's Health, Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia jane.fisher@monash.edu.""}]",BMJ open,['10.1136/bmjopen-2020-039343']
1119,31160658,Associations between Blood Pressure Indices and Brachial-ankle Pulse Wave Velocity in Treated Hypertensive Adults: results from the China Stroke Primary Prevention Trial (CSPPT).,"Brachial-ankle pulse wave velocity (baPWV), as a marker of arterial stiffness, has been demonstrated to be associated with blood pressure (BP) and onset of hypertension. However, little information is available on the associations between baPWV and BP indices [systolic BP (SBP), diastolic BP (DBP), pulse pressure (PP), mean arterial pressure (MAP)] in treated hypertensive patients. We aimed to assess the associations between BP indices and baPWV. In this cross-sectional study, 14,598 hypertensive patients from China Stroke Primary Prevention Trial (CSPPT) at the exit visit of the trial were analyzed. Elevated baPWV was defined as ≥18.3 m/s. Multivariate linear and logistic regression analyses were performed to evaluate the associations of BP indices with baPWV and elevated baPWV. Moreover, the smooth curve fitting (penalized spline method) was conducted. Multivariate linear regression analyses showed that continuous SBP, DBP, PP and MAP were independently and positively associated with baPWV (β = 0.081, 0.084, 0.078 and 0.115, respectively, all P < 0.001). Compared with controlled SBP group (<140 mm Hg), uncontrolled SBP (≥140 mm Hg) was significantly associated with higher baPWV [β = 2.234, 95% confidence interval (CI): 2.137-2.332]. Similarly, compared with controlled DBP group (<90 mm Hg), uncontrolled DBP (≥90 mm Hg) was significantly associated with higher baPWV (β = 1.466, 95%CI: 1.341-1.590). Multiple logistic analyses also showed that SBP, DBP, PP and MAP were significantly and positively associated with elevated baPWV (OR = 1.056, 1.049, 1.052, and 1.075, respectively, all P < 0.001). The fully-adjusted smooth curve fitting presented a linear association between BP indices with baPWV. In conclusion, among treated hypertensive patients, SBP, DBP, PP and MAP levels were independently and positively associated with baPWV and elevated baPWV, suggesting that baPWV might be a way to predict uncontrolled BP.",2019,"Compared with controlled SBP group (<140 mm Hg), uncontrolled SBP (≥140 mm Hg) was significantly associated with higher baPWV [β = 2.234, 95% confidence interval (CI): 2.137-2.332].","['treated hypertensive patients', '14,598 hypertensive patients from China Stroke Primary Prevention Trial (CSPPT) at the exit visit of the trial were analyzed', 'Treated Hypertensive Adults']","['controlled SBP', 'controlled DBP']","['baPWV and BP indices [systolic BP (SBP), diastolic BP (DBP), pulse pressure (PP), mean arterial pressure (MAP', 'Brachial-ankle pulse wave velocity (baPWV', 'Elevated baPWV', 'uncontrolled SBP', 'uncontrolled DBP', 'BP indices and baPWV', 'continuous SBP, DBP, PP and MAP', 'blood pressure (BP) and onset of hypertension', 'BP indices with baPWV and elevated baPWV', 'Blood Pressure Indices and Brachial-ankle Pulse Wave Velocity', 'SBP, DBP, PP and MAP', 'SBP, DBP, PP and MAP levels', 'elevated baPWV']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]","[{'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",14598.0,0.0299388,"Compared with controlled SBP group (<140 mm Hg), uncontrolled SBP (≥140 mm Hg) was significantly associated with higher baPWV [β = 2.234, 95% confidence interval (CI): 2.137-2.332].","[{'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang of Jiangxi, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Study Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang of Jiangxi, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'National Clinical Research Study Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'National Clinical Research Study Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Study Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology and Heart Center, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Genfu', 'Initials': 'G', 'LastName': 'Tang', 'Affiliation': 'School of Health Administration, Anhui University, Hefei, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology and Heart Center, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang of Jiangxi, China.'}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Bao', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang of Jiangxi, China. huihui_bao77@126.com.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology and Heart Center, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang of Jiangxi, China. xiaoshumenfan126@163.com.'}]",Scientific reports,['10.1038/s41598-019-44740-z']
1120,33068366,"A double-blinded, randomized, split-side, vehicle-controlled study of the efficacy of cleanser containing Acanthus ebracteatus Vahl., Suregada multiflora, and Acacia concinna in patients with atopic dermatitis: A pilot study.","BACKGROUND


Barrier repair therapy is the key management approach for both eczematous and non-lesional skin of atopic dermatitis. The use of appropriate cleansers to enhance skin hydration is an adjunctive treatment that increases topical drug penetration. Anti-inflammatory properties of various medicinal plants in tropical Asia have been reported.
OBJECTIVE


Investigate the efficacy of herbal cleanser containing a combination of herbal extracts from Acanthus ebracteatus Vahl., Suregada multiflora, and Acacia concinna on seemingly intact skin in patients with atopic dermatitis by measuring improvements in the skin barrier function.
METHODS


This 2-week pilot study was a split-side, randomized, double-blinded, vehicle-controlled trial. All patients (n = 30) were asked to use both a cleanser with an active formulation containing the herbal extracts and a vehicle- controlled cleanser on each side of mid-volar forearm. Biophysical assessments including transepidermal water loss (TEWL), skin hydration, skin pH, and skin roughness were performed at baseline and upon study completion.
RESULTS


Compared to baseline, the median percentage change in TEWL at the end of the study was significantly greater for the active side 10.4 (-19, 20.7) g/m2h than the control side -13.2 (-28.7, 9.1) g/m2h; p = 0.01. The median percentage change of skin hydration, skin pH, and skin roughness of the active side compared to the control side had no a statistical significance.
CONCLUSIONS


This cleanser is beneficial when used as adjunctive therapy. Further studies should evaluate its anti- sinflammatory properties in the remedy or active phase of atopic dermatitis or other inflammatory skin diseases.",2020,"The median percentage change of skin hydration, skin pH, and skin roughness of the active side compared to the control side had no a statistical significance.
","['All patients (n = 30', 'patients with atopic dermatitis']","['Barrier repair therapy', 'cleanser with an active formulation containing the herbal extracts and a vehicle- controlled cleanser', 'cleanser containing Acanthus ebracteatus Vahl., Suregada multiflora, and Acacia concinna', 'herbal cleanser']","['median percentage change of skin hydration, skin pH, and skin roughness of the active side', 'transepidermal water loss (TEWL), skin hydration, skin pH, and skin roughness', 'median percentage change in TEWL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1000628', 'cui_str': 'Acanthus'}, {'cui': 'C0950046', 'cui_str': 'Gelonium multiflora'}, {'cui': 'C0000869', 'cui_str': 'Acacia'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0232445', 'cui_str': 'Acid mantle'}, {'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",30.0,0.127699,"The median percentage change of skin hydration, skin pH, and skin roughness of the active side compared to the control side had no a statistical significance.
","[{'ForeName': 'Waranaree', 'Initials': 'W', 'LastName': 'Winayanuwattikun', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Supenya', 'Initials': 'S', 'LastName': 'Varothai', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Papapit', 'Initials': 'P', 'LastName': 'Tuchinda', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kanokvalai', 'Initials': 'K', 'LastName': 'Kulthanan', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Nuntida', 'Initials': 'N', 'LastName': 'Prasertworonun', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Phongphimon', 'Initials': 'P', 'LastName': 'Dasri', 'Affiliation': 'Center of Applied Thai Traditional Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kwanjeera', 'Initials': 'K', 'LastName': 'Wanichthanarak', 'Affiliation': 'Center of Applied Thai Traditional Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pravit', 'Initials': 'P', 'LastName': 'Akarasereenont', 'Affiliation': 'Center of Applied Thai Traditional Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Asian Pacific journal of allergy and immunology,['10.12932/AP-050519-0554']
1121,33068371,The comparison of nasal irrigation outcome between 3% NaCl and 0.9% NaCl in adults majority with intermittent allergic rhinitis: A randomized double-blind study.,"BACKGROUND


Management of allergic rhinitis with oral antihistamine and steroid nasal spray are the standard treatment which is recommended by Allergic Rhinitis and its Impact on Asthma guidelines. In addition, nasal irrigation as an adjuvant therapy also provides a satisfactory result.
OBJECTIVE


To compare the treatment outcome in adults majority with intermittent allergic rhinitis who receive different concentrations of nasal irrigation.
METHODS


The prospective randomized double-blind study was performed in 80 patients. All patients were prescribed oral antihistamine and nasal irrigated solution between 3% NaCl and 0.9% NaCl. Nasal congestion and rhinorrhea were evaluated at baseline, first and second weeks after treatment. Assessments were measured by nasal congestion visual analog scale rhinorrhea visual analog scale, inferior turbinate size, and peak nasal expiratory flow rate (PNEFR). A p value of < 0.05 was considered statistically significant.
RESULTS


There were 40 patients in each group of the study. Patients reported satisfactory experience after using saline irrigation at first and second weeks in both solutions (p value < 0.001). However, when compared between groups, no significant differences for all parameters were reported. PNEFR showed good results after the first week of 3% NaCl irrigation (p value = 0.001), while 0.9% NaCl had good results after the second week (p value < 0.001).
CONCLUSIONS


Both add-on treatments have a significant improvement of all 4 parameters assessed in the study: nasal congestion, rhinorrhea, inferior turbinate size and PNEFR. Of note, 3% NaCl but not 0.9 NaCl had improved the PNEFR earlier from 1 week of the treatment.",2020,"PNEFR showed good results after the first week of 3% NaCl irrigation (p value = 0.001), while 0.9% NaCl had good results after the second week (p value < 0.001).
","['80 patients', 'adults majority with intermittent allergic rhinitis', 'adults majority with intermittent allergic rhinitis who receive different concentrations of nasal irrigation', '40 patients in each group of the study']","['NaCl and 0.9% NaCl', 'antihistamine and nasal irrigated solution between 3% NaCl and 0.9% NaCl', 'oral antihistamine and steroid nasal spray']","['nasal congestion, rhinorrhea, inferior turbinate size and PNEFR', 'PNEFR earlier', 'Nasal congestion and rhinorrhea', 'nasal irrigation outcome', 'nasal congestion visual analog scale rhinorrhea visual analog scale, inferior turbinate size, and peak nasal expiratory flow rate (PNEFR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C1959973', 'cui_str': 'Percent sodium chloride'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}]","[{'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0225434', 'cui_str': 'Inferior nasal turbinate bone structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",80.0,0.068579,"PNEFR showed good results after the first week of 3% NaCl irrigation (p value = 0.001), while 0.9% NaCl had good results after the second week (p value < 0.001).
","[{'ForeName': 'Kedsaraporn', 'Initials': 'K', 'LastName': 'Yata', 'Affiliation': 'Otolaryngology unit, Phayao Hospital, Phayao, Thailand.'}, {'ForeName': 'Chonticha', 'Initials': 'C', 'LastName': 'Srivanitchapoom', 'Affiliation': 'Otolaryngology unit, Phayao Hospital, Phayao, Thailand.'}]",Asian Pacific journal of allergy and immunology,['10.12932/AP-140520-0844']
1122,32641226,Sacubitril/Valsartan in Advanced Heart Failure With Reduced Ejection Fraction: Rationale and Design of the LIFE Trial.,"The PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial reported that sacubitril/valsartan (S/V), an angiotensin receptor-neprilysin inhibitor, significantly reduced mortality and heart failure (HF) hospitalization in HF patients with a reduced ejection fraction (HFrEF). However, fewer than 1% of patients in the PARADIGM-HF study had New York Heart Association (NYHA) functional class IV symptoms. Accordingly, data that informed the use of S/V among patients with advanced HF were limited. The LIFE (LCZ696 in Hospitalized Advanced Heart Failure) study was a 24-week prospective, multicenter, double-blinded, double-dummy, active comparator trial that compared the safety, efficacy, and tolerability of S/V with those of valsartan in patients with advanced HFrEF. The trial planned to randomize 400 patients ≥18 years of age with advanced HF, defined as an EF ≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP] ≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP] ≥800 pg/ml), and ≥1 objective finding of advanced HF. Following a 3- to 7-day open label run-in period with S/V (24 mg/26 mg twice daily), patients were randomized 1:1 to S/V titrated to 97 mg/103 mg twice daily versus 160 mg of V twice daily. The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24. Secondary and tertiary endpoints included clinical outcomes and safety and tolerability. Because of the COVID-19 pandemic, enrollment in the LIFE trial was stopped prematurely to ensure patient safety and data integrity. The primary analysis consists of the first 335 randomized patients whose clinical follow-up examination results were not severely impacted by COVID-19. (Entresto [LCZ696] in Advanced Heart Failure [LIFE STUDY] [HFN-LIFE]; NCT02816736).",2020,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"['400 patients\xa0≥18 years of age with advanced HF, defined as an EF\xa0≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP]\xa0≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP]\xa0≥800 pg/ml), and\xa0≥1 objective finding of advanced HF', 'patients with advanced HF', 'Failure With Reduced Ejection Fraction', 'Heart\xa0Failure', 'Advanced Heart\xa0Failure [LIFE STUDY', 'HF patients with a reduced ejection fraction (HFrEF', 'Advanced Heart', 'patients with advanced HFrEF']","['Entresto [LCZ696', 'valsartan', 'Angiotensin II Receptor Blocker Neprilysin Inhibitor', 'Angiotensin-Converting Enzyme Inhibitor', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'LIFE (LCZ696']","['mortality and heart failure (HF) hospitalization', 'proportional change from baseline in the area under the curve for NT-proBNP levels', 'Global Mortality and Morbidity', 'safety, efficacy, and tolerability', 'clinical outcomes and safety and tolerability']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4033616', 'cui_str': 'Entresto'}, {'cui': 'C2933615', 'cui_str': 'LCZ 696'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C4760695', 'cui_str': 'Neprilysin inhibitor'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",335.0,0.331951,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"[{'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Mann', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri. Electronic address: dmann@wustl.edu.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Vader', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Palak', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Mahr', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Selma F', 'Initials': 'SF', 'LastName': 'Mohammed', 'Affiliation': 'MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Nisha A', 'Initials': 'NA', 'LastName': 'Gilotra', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eiran Z', 'Initials': 'EZ', 'LastName': 'Gorodeski', 'Affiliation': 'Department of Medicine, Harrington Heart and Vascular Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Baltimore, Maryland.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2020.05.005']
1123,32643265,Multi-focal electro-retinogram response following sub-threshold nano-second laser intervention in age-related macular degeneration.,"IMPORTANCE


The effect of sub-threshold nano-second laser (SNL) treatment on retinal function remains unknown.
BACKGROUND


SNL treatment has been studied as a potential intervention in intermediate age-related macular degeneration (iAMD). This study investigated the longitudinal effect of SNL treatment on retinal function.
DESIGN


This was a sub-study of the LEAD trial; a 36-month, multi-centre, randomized and sham-controlled trial.
PARTICIPANTS


Subjects with iAMD.
METHODS


Eligible participants were assigned randomly to receive SNL or sham treatment to the study eye at 6-monthly visits. Multi-focal electro-retinography (mfERG) was performed at each study visit from a study site. The mfERG responses were grouped into three regions (central, middle and outer rings) and compared between the SNL and sham group.
MAIN OUTCOME MEASURES


mfERG P1 response amplitude and implicit time.
RESULTS


Data were collected from 50 subjects (26 in the SNL group, 24 in the sham group). At baseline, the P1 amplitudes of both the study eyes and the fellow eyes were similar between the groups at all rings. In the sham group, the P1 amplitude gradually decreased over time (P < .05). In the SNL group, there was an improvement in P1 amplitude which became statistically significant at the 36-month visit, detected in both the treated and fellow eyes at the central (P = .005) and middle ring (P = .007) but not at the outer ring (P = .070). No difference in P1 implicit time detected between the groups (P > .05).
CONCLUSIONS AND RELEVANCE


SNL treatment improved electro-physiological function. mfERG could be useful for monitoring AMD progression and evaluating the efficacy of SNL treatment.",2020,"At baseline, the P1 amplitudes of both the study eyes and the fellow eyes were similar between the groups at all rings.","['age-related macular degeneration', 'Eligible participants', 'Subjects with iAMD', '50 subjects (26 in the SNL group, 24 in the sham group']","['subthreshold nanosecond laser intervention', 'SNL', 'subthreshold nanosecond laser (SNL', 'Multifocal electroretinography (mfERG']","['P1 implicit time', 'mfERG P1 response amplitude and implicit time', 'P1 amplitudes', 'Multifocal electroretinogram response', 'P1 amplitude', 'retinal function', 'electrophysiological function']","[{'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0439225', 'cui_str': 'ns'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0439225', 'cui_str': 'ns'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1627756', 'cui_str': 'Multifocal electroretinography'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1627756', 'cui_str': 'Multifocal electroretinography'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C0456358', 'cui_str': 'ERG response'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",50.0,0.0750606,"At baseline, the P1 amplitudes of both the study eyes and the fellow eyes were similar between the groups at all rings.","[{'ForeName': 'Chi D', 'Initials': 'CD', 'LastName': 'Luu', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Makeyeva', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Caruso', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Baglin', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Pyrawy', 'Initials': 'P', 'LastName': 'Sivarajah', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Robyn H', 'Initials': 'RH', 'LastName': 'Guymer', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}]",Clinical & experimental ophthalmology,['10.1111/ceo.13823']
1124,32645640,The ocrelizumab phase II extension trial suggests the potential to improve the risk: Benefit balance in multiple sclerosis.,"OBJECTIVE


Ocrelizumab inhibits relapsing multiple sclerosis when administered every six months. Based on potential similar memory B cell depletion mechanisms with cladribine and alemtuzumab, we hypothesised that CD20-depletion of B cells by ocrelizumab may exhibit a duration of response exceeding the current licenced treatment interval.
METHODS


Internet-located information from regulatory submissions and meeting reports relating to the unpublished open-label, phase II ocrelizumab extension trial (NCT00676715) were reviewed. This followed people (54-55/arm) with MS, who switched from placebo or interferon-beta to ocrelizumab for three 600 mg treatment cycles (week 24, 48, 72) or people treated with ocrelizumab for four 600 mg treatment cycles (week 0-72), followed by an 18 month treatment-free period.
RESULTS


CD19+ B cells were rapidly depleted within 2 weeks and slow CD19+ B cell repopulation began about 6 months after the last infusion with median-repletion of over 15 months. The reduced annualized relapse rate during the published efficacy study appeared to be maintained in the extension study and there were no new T1 gadolinium-enhancing or T2 lesions detected in the treatment-free period. Importantly, within these extension cohorts, there appeared to be fewer adverse events and infections events.
CONCLUSIONS


Ocrelizumab appears to induce durable relapsing disease inhibition, within 3 treatment cycles Therefore, it may be possible to reduce the frequency of dosing to maintain efficacy, whilst limiting infection and other risks associated with continuous immunosuppression and could allow more effective vaccination against new pathogens. Further studies are now clearly required to determine whether this data is robust.",2020,"CONCLUSIONS


Ocrelizumab appears to induce durable relapsing disease inhibition, within 3 treatment cycles",[],"['placebo or interferon-beta to ocrelizumab', 'cladribine and alemtuzumab', 'Ocrelizumab', 'ocrelizumab']","['annualized relapse rate', 'new T1 gadolinium-enhancing or T2 lesions']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015980', 'cui_str': 'Interferon-beta'}, {'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0383429', 'cui_str': 'alemtuzumab'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",,0.0255681,"CONCLUSIONS


Ocrelizumab appears to induce durable relapsing disease inhibition, within 3 treatment cycles","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baker', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom. Electronic address: david.baker@qmul.ac.uk.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Pryce', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom.'}, {'ForeName': 'Louisa K', 'Initials': 'LK', 'LastName': 'James', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Marta', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom; Clinical Board:Medicine (Neuroscience), The Royal London Hospital, Barts Health NHS Trust, London E1 1BB, United Kingdom.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Schmierer', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom; Clinical Board:Medicine (Neuroscience), The Royal London Hospital, Barts Health NHS Trust, London E1 1BB, United Kingdom.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102279']
1125,32650074,A break-even analysis of benzoyl peroxide and hydrogen peroxide for infection prevention in shoulder arthroplasty.,"BACKGROUND


Newer strategies to decolonize the shoulder of Cutibacterium acnes may hold promise in minimizing the occurrence of infections after shoulder arthroplasty, but little is known about their cost-effectiveness. Break-even models can determine the economic viability of interventions in settings with low outcome event rates that would realistically preclude a randomized clinical trial. We used such modeling to determine the economic viability of benzoyl peroxide and hydrogen peroxide for infection prevention in shoulder arthroplasty.
METHODS


Skin decolonization protocol costs ($11.76 for benzoyl peroxide; $0.96 for hydrogen peroxide), baseline infection rates for shoulder arthroplasty (0.70%), and infection-related care costs ($50,230) were derived from institutional records and the literature. A break-even equation incorporating these variables was developed to determine the absolute risk reduction (ARR) in the infection rate to make prophylactic use economically justified. The number needed to treat was calculated from the ARR.
RESULTS


Topical benzoyl peroxide is considered economically justified if it prevents at least 1 infection out of 4348 shoulder arthroplasties (ARR = 0.023%). Hydrogen peroxide is economically justified if it prevents at least 1 infection out of 50,000 cases (ARR = 0.002%). These protocols remained economically viable at varying unit costs, initial infection rates, and infection-related care costs.
CONCLUSIONS


The use of topical benzoyl peroxide and skin preparations with hydrogen peroxide are highly economically justified practices for infection prevention in shoulder arthroplasty. Efforts to determine drawbacks of routine skin decolonization strategies are warranted as they may change the value analysis.",2020,"These protocols remained economically viable at varying unit costs, initial infection rates, and infection-related care costs.
","['shoulder arthroplasty', 'shoulder arthroplasty (0.70%), and infection-related care costs ($50,230', 'Shoulder Arthroplasty']","['benzoyl peroxide and hydrogen peroxide', 'Hydrogen peroxide', 'topical benzoyl peroxide and skin preparations with hydrogen peroxide', 'benzoyl peroxide; $0.96 for hydrogen peroxide', 'Benzoyl Peroxide and Hydrogen Peroxide']","['initial infection rates, and infection-related care costs']","[{'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]","[{'cui': 'C0005088', 'cui_str': 'Benzoyl Peroxide'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0455085', 'cui_str': 'Skin preparation'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",50230.0,0.0321727,"These protocols remained economically viable at varying unit costs, initial infection rates, and infection-related care costs.
","[{'ForeName': 'Mariano E', 'Initials': 'ME', 'LastName': 'Menendez', 'Affiliation': 'Department of Orthopaedic Surgery, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA; Department of Orthopaedic Surgery, Newton-Wellesley Hospital, Newton, MA, USA. Electronic address: marianofurrer@gmail.com.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Moverman', 'Affiliation': 'Department of Orthopaedic Surgery, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA; Department of Orthopaedic Surgery, Newton-Wellesley Hospital, Newton, MA, USA.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Puzzitiello', 'Affiliation': 'Department of Orthopaedic Surgery, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA; Department of Orthopaedic Surgery, Newton-Wellesley Hospital, Newton, MA, USA.'}, {'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Pagani', 'Affiliation': 'Department of Orthopaedic Surgery, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA; Department of Orthopaedic Surgery, Newton-Wellesley Hospital, Newton, MA, USA.'}, {'ForeName': 'Surena', 'Initials': 'S', 'LastName': 'Namdari', 'Affiliation': 'Rothman Institute, Thomas Jefferson University, Philadelphia, PA, USA.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.06.019']
1126,32650077,Deltopectoral vs. deltoid split approach for proximal HUmerus fracture fixation with locking plate: a prospective RAndomized study (HURA).,"BACKGROUND


This study aimed to compare the functional and clinical outcomes between the deltoid split (DS) approach and the classic deltopectoral (DP) approach for locking plate fixation of proximal humerus fractures (PHF) in a prospective randomized multicenter study.
METHODS


From 2007 to 2015, all patients with a PHF Neer II/III were invited to participate. Exclusion criteria were pre-existing pathology to the limb, patient refusing or too ill to undergo surgery, patient needing another type of treatment (nail, arthroplasty), and axillary nerve impairment. After consent, patients were randomized to one of the 2 treatments using the dark envelope method. Functional outcome was evaluated by validated questionnaires (12-Item Short Form Health Survey: version 2, Quick-DASH) with a minimum follow-up of 12 months. Complications were noted.
RESULTS


A total of 85 patients (44 DS, 41 DP) were randomized (mean age of 62). Groups were equivalent in terms of age, gender, body mass index, severity of fracture, and preinjury scores. The mean follow-up was 26 months. All clinical outcome measures were in favor of the deltopectoral approach. Specifically, the Q-DASH and SF-12v2 were better in the DP group (12 vs. 26, P = .003 and 56 vs. 51, P = .049, respectively). There were more complications in DS patients, but they did not reach statistical significance.
CONCLUSIONS


The primary hypothesis on the superiority of the deltoid split incision was rebutted. On the basis of our study, the DP approach seems to offer better function compared with the DS approach for fixation of Neer 2 and 3 PHF fractures fixed with a locking plate.",2020,"Specifically, the Q-DASH, was better in the DP group (12 vs 26, p=0,003) and SF-12v2: 56 vs 51, p=0,049, respectively).","['85 patients (44 DS, 41 DP', 'From 2007 to 2015, all patients with a PHF Neer II/III, were invited to participate', 'proximal humerus fractures (PHF', 'Exclusion criteria were: pre-existing pathology to the limb, patient refusing or too ill to undergo surgery, patient needing another type of treatment (nail, arthroplasty), and axillary nerve impairment']","['Delto-Pectoral vs Deltoid split approach', 'deltoid split (DS) approach and the classic deltopectoral (DP) approach']",['Complications'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0450110', 'cui_str': 'Deltopectoral approach'}, {'cui': 'C0588209', 'cui_str': 'Bone structure of proximal humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0228885', 'cui_str': 'Structure of axillary nerve'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]","[{'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0450110', 'cui_str': 'Deltopectoral approach'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0329204,"Specifically, the Q-DASH, was better in the DP group (12 vs 26, p=0,003) and SF-12v2: 56 vs 51, p=0,049, respectively).","[{'ForeName': 'Dominique M', 'Initials': 'DM', 'LastName': 'Rouleau', 'Affiliation': 'CIUSS, Hopital Sacré Coeur de Montréal, Montréal, QC, Canada; Faculty of Medicine, Université de Montréal, Montréal, QC, Canada. Electronic address: dominique.rouleau@umontreal.ca.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Balg', 'Affiliation': 'Department of surgery, Centre universitaire de santé de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Benoit', 'Affiliation': 'CIUSS, Hopital Sacré Coeur de Montréal, Montréal, QC, Canada; Faculty of Medicine, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Leduc', 'Affiliation': 'CIUSS, Hopital Sacré Coeur de Montréal, Montréal, QC, Canada; Faculty of Medicine, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Malo', 'Affiliation': 'CIUSS, Hopital Sacré Coeur de Montréal, Montréal, QC, Canada; Faculty of Medicine, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Vézina', 'Affiliation': 'Department of surgery, Centre universitaire de santé de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'G Yves', 'Initials': 'GY', 'LastName': 'Laflamme', 'Affiliation': 'CIUSS, Hopital Sacré Coeur de Montréal, Montréal, QC, Canada; Faculty of Medicine, Université de Montréal, Montréal, QC, Canada.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.06.020']
1127,32650155,Comparative effects of water- and land-based combined exercise training in hypertensive older adults.,"OBJECTIVES


A randomized controlled trial was designed to compare water- and land-based combined (aerobic and resistance) exercise training programs on cardiometabolic parameters, functional fitness, and quality-of-life (QoL) in hypertensive older adults.
METHODS


Fifty-three participants were divided into three groups: 1) land-based exercise group (LET, n=17), 2) water-based exercise group (WET, n=16), and 3) control group (CON, n=20). All programs comprised of a 12-week supervised training program (three 1-hr sessions per week), followed by a 12-week self-supervised training program. Blood pressure (BP), glutathione peroxidase (GPx), total nitrite/nitrate (NOx-), malondialdehyde (MDA), high-sensitive C-reactive protein (hs-CRP), blood lipids, functional fitness, and QoL were assessed before and after each period.
RESULTS


Following the supervised period, systolic BP, rate-pressure product, GPx, NOx-, MDA, hs-CRP concentrations, physical and psychological domains, and overall QoL significantly improved in both training groups. Only the WET improved LDL-C and lipoprotein combine index. Meanwhile, the 30s chair-stand test and 2-min step test improved only in the LET. Succeeding the self-supervised period, systolic BP and NOx- concentration significantly improved in both training groups. Notwithstanding, the 30s chair-standing and arm curl tests improved only in the LET.
CONCLUSIONS


Both training programs rendered ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL with a higher progression in the LET. Nevertheless, metabolic variables were greater improved in the WET. Additionally, due to greater exercise participation, the WET program may be a useful tool in motivating hypertensive older adults to continuously exercise on their own.",2020,"Both training programs rendered ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL with a higher progression in the LET.","['hypertensive older adults', 'motivating hypertensive older adults', 'Fifty-three participants were divided into three groups: 1']","['water- and land-based combined (aerobic and resistance) exercise training programs', 'land-based exercise group (LET, n=17), 2) water-based exercise group (WET, n=16), and 3) control group (CON', 'supervised training program', 'water- and land-based combined exercise training']","['metabolic variables', 'ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL', 'cardiometabolic parameters, functional fitness, and quality-of-life (QoL', 'systolic BP and NOx- concentration', 'Blood pressure (BP), glutathione peroxidase (GPx), total nitrite/nitrate (NOx-), malondialdehyde (MDA), high-sensitive C-reactive protein (hs-CRP), blood lipids, functional fitness, and QoL', 'LDL-C and lipoprotein combine index', 'systolic BP, rate-pressure product, GPx, NOx-, MDA, hs-CRP concentrations, physical and psychological domains, and overall QoL']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0086562', 'cui_str': 'Energy Transfer, Linear'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",53.0,0.0142118,"Both training programs rendered ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL with a higher progression in the LET.","[{'ForeName': 'Ratree', 'Initials': 'R', 'LastName': 'Ruangthai', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Jatuporn', 'Initials': 'J', 'LastName': 'Phoemsapthawee', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand. Electronic address: jatuporn.w@ku.th.'}, {'ForeName': 'Niromlee', 'Initials': 'N', 'LastName': 'Makaje', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Phornphon', 'Initials': 'P', 'LastName': 'Phimphaphorn', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104164']
1128,32657920,Banded Versus Nonbanded Sleeve Gastrectomy: A Randomized Controlled Trial With 3 Years of Follow-up.,"OBJECTIVE


The aim of this study was to compare silicone-banded sleeve gastrectomy (BSG) to nonbanded sleeve gastrectomy (SG) regarding weight loss, obesity-related comorbidities, and complications.
SUMMARY BACKGROUND DATA


As a primary bariatric procedure, SG leads to excellent weight loss, yet weight regain is a relevant issue in mid- to long-term follow-up. Retrospective analyses suggest that banding a sleeve using a silicone ring may decrease weight regain and improve weight loss.
METHODS


The banded versus nonbanded sleeve gastrectomy single-center, randomized controlled trial was conducted from January 2015 to August 2019. The primary endpoint was defined as excess weight loss 3 years after surgery. Secondary endpoints included the surgery's impact on obesity-related comorbidities, quality of life, and complications. The study was registered under DRKS00007729.
RESULTS


Among 94 patients randomized, 97% completed 3-year follow-up. Mean initial body mass index was 50.9 kg/m [95% confidence interval (CI), 49.6-52.2]. Mean adjusted excess weight loss 3 years after SG amounted to 62.3% (95% CI, 56.2-68.5) and 73.9% ( 95% CI, 67.8-80.0) after BSG (difference 11.6%, P = 0.0073). Remission of type 2 diabetes occurred in 66.7% (4/6) after SG and in 91.0% (10/11) following BSG (P = 0.21). Three years after surgery, ring implantation correlated with decreased frequency of symptomatic reflux episodes (P = 0.01) but increased frequency of regurgitation (P = 0.03). The rate of major complications was not different between the study groups (BSG, n = 3; SG, n = 2; P = 0.63). Quality of life was better following BSG (P = 0.001).
CONCLUSIONS


BSG provided better weight loss than nonbanded SG 3 years after surgery. Regurgitation was the main clinically relevant negative effect after BSG.",2020,"Quality of life was better following BSG (P = 0.001).
","['94 patients randomized, 97% completed 3-year follow-up']","['banded versus nonbanded sleeve gastrectomy single-center', 'Banded Versus Nonbanded Sleeve Gastrectomy', 'silicone-banded sleeve gastrectomy (BSG', 'nonbanded sleeve gastrectomy (SG']","['Remission of type 2 diabetes', 'frequency of symptomatic reflux episodes', 'Mean initial body mass index', 'weight regain and improve weight loss', 'Mean adjusted excess weight loss 3 years after SG', 'frequency of regurgitation', 'weight loss', ""surgery's impact on obesity-related comorbidities, quality of life, and complications"", 'excess weight loss 3 years after surgery', 'Quality of life', 'rate of major complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",94.0,0.15993,"Quality of life was better following BSG (P = 0.001).
","[{'ForeName': 'Jodok M', 'Initials': 'JM', 'LastName': 'Fink', 'Affiliation': 'Department of General and Visceral Surgery, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hetzenecker', 'Affiliation': ''}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Seifert', 'Affiliation': ''}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Runkel', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Laessle', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Fichtner-Feigl', 'Affiliation': ''}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Marjanovic', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004174']
1129,32653895,Optimizing behavior therapy for youth with Tourette's disorder.,"Tourette's Disorder (TD) is characterized by tics that cause distress and impairment. While treatment guidelines recommend behavior therapy as a first-line intervention, patients with TD may exhibit limited therapeutic response. Given the need to improve treatment outcomes, this study examined the efficacy of augmenting behavior therapy with D-cycloserine (DCS) to reduce tic severity in a placebo-controlled quick-win/fast-fail trial. Twenty youth with TD completed a baseline assessment to characterize tic severity, premonitory urges, medical history, and psychiatric comorbidity. Youth were randomly assigned to receive a single session of habit reversal training (HRT) augmented by either 50 mg of DCS or placebo. Two bothersome tics on the Hopkins Motor/Vocal Tic Scale (HM/VTS) were targeted for treatment during HRT. One week after the HRT session, youth completed a posttreatment assessment to evaluate change in the severity of bothersome tics. All assessments were completed by independent evaluators masked to treatment group. There was a Treatment Group by Time Interaction in favor of DCS-augmented HRT (p < 0.01), controlling for baseline tic severity, tic medication, and attention deficit hyperactivity disorder. Follow-up comparisons revealed small group differences at the treatment visit (d = 0.27), with the DCS group exhibiting slightly greater severity for targeted tics. There was a large group difference at posttreatment, in which the DCS group exhibited lower severity for targeted tics (d = 1.30, p < 0.001) relative to the placebo group. Findings demonstrate the preliminary enhancement of tic severity reductions by augmenting HRT with DCS compared with placebo augmentation.",2020,"There was a Treatment Group by Time Interaction in favor of DCS-augmented HRT (p < 0.01), controlling for baseline tic severity, tic medication, and attention deficit hyperactivity disorder.","[""youth with Tourette's disorder"", 'Twenty youth with TD completed a baseline assessment to characterize tic severity, premonitory urges, medical history, and psychiatric comorbidity']","['placebo', 'habit reversal training (HRT) augmented by either 50\u2009mg of DCS or placebo', 'DCS', 'behavior therapy with D-cycloserine (DCS']","['Hopkins Motor/Vocal Tic Scale (HM/VTS', 'targeted tics', 'severity of bothersome tics']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0040517', 'cui_str': ""Gilles de la Tourette's syndrome""}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0751901', 'cui_str': 'Tic, Vocal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",20.0,0.322576,"There was a Treatment Group by Time Interaction in favor of DCS-augmented HRT (p < 0.01), controlling for baseline tic severity, tic medication, and attention deficit hyperactivity disorder.","[{'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'McGuire', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA. jfmcguire@jhmi.edu.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Ginder', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Kesley', 'Initials': 'K', 'LastName': 'Ramsey', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Joey Ka-Yee', 'Initials': 'JK', 'LastName': 'Essoe', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Ricketts', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'McCracken', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0762-4']
1130,32654588,Effects of aerobic exercise and cognitively engaging exercise on cardiorespiratory fitness and motor skills in primary school children: A cluster randomized controlled trial.,"This paper examined effects of two interventions on cardiorespiratory fitness and motor skills, and whether these effects are influenced by baseline levels, and dose of moderate-to-vigorous physical activity (MVPA) during the intervention. A cluster randomized controlled trial was implemented in 22 schools (n = 891; 9.2 ± 07 years). Intervention groups received aerobic or cognitively engaging exercise (14-weeks, four lessons per week). Control groups followed their regular physical education programme. Cardiorespiratory fitness, motor skills and MVPA were assessed. Multilevel analysis showed no main effects on cardiorespiratory fitness and motor skills although the amount of MVPA was higher in the aerobic than in the cognitively engaging and control group. Intervention effects did not depend on baseline cardiorespiratory fitness and motor skills. Children with a higher dose of MVPA within the intervention groups had better cardiorespiratory fitness after both interventions and better motor skills after the cognitively engaging intervention. In conclusion, the interventions were not effective to enhance cardiorespiratory fitness and motor skills at a group level, possibly due to large individual differences and to a total dose of MVPA too low to find effects. However, the amount of MVPA is an important factor that influence the effectiveness of interventions.",2020,Children with a higher dose of MVPA within the intervention groups had better cardiorespiratory fitness after both interventions and better motor skills after the cognitively engaging intervention.,"['primary school children', '22 schools (n\xa0=\xa0891; 9.2\xa0±\xa007\xa0years']","['MVPA', 'aerobic exercise and cognitively engaging exercise', 'aerobic or cognitively engaging exercise', 'regular physical education programme']","['Cardiorespiratory fitness, motor skills and MVPA', 'MVPA', 'motor skills', 'cardiorespiratory fitness and motor skills', 'baseline cardiorespiratory fitness and motor skills', 'cardiorespiratory fitness']","[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.0403646,Children with a higher dose of MVPA within the intervention groups had better cardiorespiratory fitness after both interventions and better motor skills after the cognitively engaging intervention.,"[{'ForeName': 'Irene M J', 'Initials': 'IMJ', 'LastName': 'van der Fels', 'Affiliation': 'Center for Human Movement Sciences, University of Groningen, University Medical Center Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Hartman', 'Affiliation': 'Center for Human Movement Sciences, University of Groningen, University Medical Center Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Roel J', 'Initials': 'RJ', 'LastName': 'Bosker', 'Affiliation': 'Groningen Institute for Educational Research, University of Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Johannes W', 'Initials': 'JW', 'LastName': 'de Greeff', 'Affiliation': 'Center for Human Movement Sciences, University of Groningen, University Medical Center Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Anne G M', 'Initials': 'AGM', 'LastName': 'de Bruijn', 'Affiliation': 'Groningen Institute for Educational Research, University of Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Meijer', 'Affiliation': 'Clinical Neuropsychology Section, Vrije Universiteit , Amsterdam, The Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Oosterlaan', 'Affiliation': ""Amsterdam Medical Center, Emma Children's Hospital , Amsterdam, The Netherlands.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Center for Human Movement Sciences, University of Groningen, University Medical Center Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Visscher', 'Affiliation': 'Center for Human Movement Sciences, University of Groningen, University Medical Center Groningen , Groningen, The Netherlands.'}]",Journal of sports sciences,['10.1080/02640414.2020.1765464']
1131,32660716,Comparing erector spinae plane block with serratus anterior plane block for minimally invasive thoracic surgery: a randomised clinical trial.,"BACKGROUND


Minimally invasive thoracic surgery causes significant postoperative pain. Erector spinae plane (ESP) block and serratus anterior plane (SAP) block promise effective thoracic analgesia compared with systemically administered opioids, but have never been compared in terms of terms of quality of recovery and overall morbidity after minimally invasive thoracic surgery.
METHODS


Sixty adult patients undergoing minimally invasive thoracic surgery were randomly assigned to receive either single-shot ESP or SAP block before surgery using levobupivacaine 0.25%, 30 ml. The primary outcome was quality of patient recovery at 24 h, using the Quality of Recovery-15 (QoR-15) scale. Secondary outcomes included area under the curve (AUC) of pain verbal rating scale (VRS) over time, time to first opioid analgesia, postoperative 24 h opioid consumption, in-hospital comprehensive complication index (CCI) score and hospital stay.
RESULTS


The QoR-15 score was higher among ESP patients compared with those in the SAP group, mean (standard deviation): 114 (16) vs 102 (22) (P=0.02). Time (min) to first i.v. opioid analgesia in recovery was 32.6 (20.6) in ESP vs 12.7 (9.5) in SAP (P=0.003). AUC at rest was 92 (31) mm h -1 vs 112 (35) in ESP and SAP (P=0.03), respectively, whereas AUC on deep inspiration was 107 mm h -1  (32) vs 129 (32) in ESP and SAP (P=0.01), respectively. VRS pain on movement in ESP and SAP at 24 h was, median (25-75% range): 4 (2-4) vs 5 (3-6) (P=0.04), respectively. Opioid consumption at 24 h postoperatively was 29 (31) vs 39 (34) (P=0.37). Median (25-75%) CCI in ESP and SAP was 1 (0-2) vs 4 (0-26) (P=0.03), whereas hospital stay was 3 (2-6) vs 6 (3-9) days (P=0.17), respectively.
CONCLUSION


Compared with SAP, ESP provides superior quality of recovery at 24 h, lower morbidity, and better analgesia after minimally invasive thoracic surgery.
CLINICAL TRIAL REGISTRATION


NCT03862612.",2020,Opioid consumption at 24 h postoperatively was 29 (31) vs 39 (34) (P=0.37).,"['minimally invasive thoracic surgery', 'Sixty adult patients undergoing minimally invasive thoracic surgery']","['Erector spinae plane (ESP) block and serratus anterior plane (SAP) block', 'SAP, ESP', 'erector spinae plane block with serratus anterior plane block', 'single-shot ESP or SAP block before surgery using levobupivacaine']","['QoR-15 score', 'opioid analgesia in recovery', 'CCI in ESP and SAP', 'lower morbidity, and better analgesia', 'VRS pain on movement in ESP and SAP', 'area under the curve (AUC) of pain verbal rating scale (VRS) over time, time to first opioid analgesia, postoperative 24 h opioid consumption, in-hospital comprehensive complication index (CCI) score and hospital stay', 'postoperative pain', 'quality of recovery and overall morbidity', 'quality of patient recovery at 24 h, using the Quality of Recovery-15 (QoR-15) scale', 'hospital stay', 'Opioid consumption', 'AUC on deep inspiration']","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]",60.0,0.312774,Opioid consumption at 24 h postoperatively was 29 (31) vs 39 (34) (P=0.37).,"[{'ForeName': 'Dylan T', 'Initials': 'DT', 'LastName': 'Finnerty', 'Affiliation': 'Division of Anaesthesiology, Mater Misericordiae University Hospital, Dublin, Ireland; School of Medicine, University College Dublin, Dublin, Ireland; EU COST Action 15204 Euro-Periscope, Brussels, Belgium. Electronic address: dylantfinnerty@gmail.com.'}, {'ForeName': 'Aisling', 'Initials': 'A', 'LastName': 'McMahon', 'Affiliation': 'Division of Anaesthesiology, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'McNamara', 'Affiliation': 'Division of Anaesthesiology, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Hartigan', 'Affiliation': 'Division of Anaesthesiology, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Griffin', 'Affiliation': 'Division of Anaesthesiology, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Donal J', 'Initials': 'DJ', 'LastName': 'Buggy', 'Affiliation': 'Division of Anaesthesiology, Mater Misericordiae University Hospital, Dublin, Ireland; School of Medicine, University College Dublin, Dublin, Ireland; EU COST Action 15204 Euro-Periscope, Brussels, Belgium; Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.06.020']
1132,32665460,Twelve-Month Outcomes of Community-Based Differentiated Models of Multimonth Dispensing of ART Among Stable HIV-Infected Adults in Lesotho: A Cluster-Randomized Noninferiority Trial.,"BACKGROUND


Lesotho adopted the test-and-treat approach for HIV treatment in June 2016, which increased antiretroviral treatment (ART) clinic volume. We evaluated community-based vs. facility-based differentiated models of multimonth dispensing of ART among stable HIV-infected adults in Lesotho.
METHODS


Thirty facilities were randomized to 3 arms, facility 3-monthly ART (3MF) (control), community ART groups (3MC), and 6-monthly community distribution points (6MCD). We estimated risk differences (RDs) between arms using population-averaged generalized estimating equations, controlling for baseline imbalances and specifying for clustering. The primary outcome was retention in ART care by intention-to-treat and virologic suppression as a secondary outcome (ClinicalTrials.gov: NCT03438370).
RESULTS


A total of 5,336 participants were enrolled, with 1898, 1558, and 1880 in 3MF, 3MC, and 6MCD, respectively. Retention in ART care was not different across arms and achieved the prespecified noninferiority limit (-3.25%) between 3MC vs. 3MF (control); 6MCD vs. 3MF; and 6MCD vs. 3MC, adjusted RD = -0.1% [95% confidence interval (CI): -1.6% to 1.5%], adjusted RD = -1.3% (95% CI: -3.0% to 0.5%), and adjusted RD = -1.2% (95% CI: -2.9% to 0.5%), respectively. After 12 months, 98.6% (n = 1503), 98.1% (n = 1126), and 98.3% (n = 1285) were virally load (VL) suppressed in 3MF, 3MC, and 6MCD, respectively. There were no differences in VL between 3MC vs. control and 6MCD vs. control, risk ratio (RR) = 1.00 (95% CI: 0.98 to 1.01) and RR = 1.00 (95% CI: 0.98 to 1.01), respectively.
CONCLUSIONS


There were no differences in retention and VL suppression for stable HIV-infected participants receiving multimonth dispensing of ART within community-based differentiated models when compared with the facility-based standard-of-care model.",2020,"Retention in ART care was not different across arms and achieved the pre-specified non-inferiority limit (-3.25%) between 3MC vs. 3MF (control); 6MCD vs. 3MF; and 6MCD vs. 3MC, adjusted RD= -0.1% (95% CI: -1.6% to 1.5%), adjusted RD= -1.3% (95% CI: -3.0% to 0.5%), and adjusted RD= -1.2% (95% CI:","['stable HIV-infected adults in Lesotho', '5,336 participants were enrolled, 1,898 3MF, 1,558 3MC and 1,880 in 3MF, 3MC and 6MCD respectively', 'Thirty facilities']","['facility 3-monthly ART (3MF) (control), community ART groups (3MC); and 6-monthly community distribution points (6MCD']","['VL between 3MC vs. control, and 6MCD vs. control, risk ratio (RR) ', 'retention and VL suppression', 'retention in ART care by intention-to-treat, and virologic suppression']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023376', 'cui_str': 'Lesotho'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}]",5336.0,0.280292,"Retention in ART care was not different across arms and achieved the pre-specified non-inferiority limit (-3.25%) between 3MC vs. 3MF (control); 6MCD vs. 3MF; and 6MCD vs. 3MC, adjusted RD= -0.1% (95% CI: -1.6% to 1.5%), adjusted RD= -1.3% (95% CI: -3.0% to 0.5%), and adjusted RD= -1.2% (95% CI:","[{'ForeName': 'Betty B', 'Initials': 'BB', 'LastName': 'Tukei', 'Affiliation': 'Right to Care/EQUIP Health, Maseru, Lesotho.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Fatti', 'Affiliation': ""Kheth'Impilo AIDS Free Living, Cape Town, South Africa.""}, {'ForeName': 'Appolinaire', 'Initials': 'A', 'LastName': 'Tiam', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Ngorima-Mabhena', 'Affiliation': ""Kheth'Impilo AIDS Free Living, Cape Town, South Africa.""}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Tukei', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC.'}, {'ForeName': 'Itumeleng', 'Initials': 'I', 'LastName': 'Tshabalala', 'Affiliation': 'Lesotho Ministry of Health Maseru, Lesotho.'}, {'ForeName': 'Veronica M', 'Initials': 'VM', 'LastName': 'Sejana', 'Affiliation': 'Right to Care/EQUIP Health, Maseru, Lesotho.'}, {'ForeName': 'Trish', 'Initials': 'T', 'LastName': 'Muzenda', 'Affiliation': ""Kheth'Impilo AIDS Free Living, Cape Town, South Africa.""}, {'ForeName': 'Lincoln M', 'Initials': 'LM', 'LastName': 'Mokoroane', 'Affiliation': 'Right to Care/EQUIP Health, Maseru, Lesotho.'}, {'ForeName': 'Lebelang', 'Initials': 'L', 'LastName': 'Sehlabo', 'Affiliation': 'Right to Care/EQUIP Health, Maseru, Lesotho.'}, {'ForeName': 'Thapelo', 'Initials': 'T', 'LastName': 'Maotoe', 'Affiliation': 'Right to Care/EQUIP Health, South Africa.'}, {'ForeName': 'Justine K', 'Initials': 'JK', 'LastName': 'Mirembe', 'Affiliation': 'Division of Prevention Care and Treatment, U.S. Agency for International Development, Washington, DC.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Membe', 'Affiliation': 'Division of Prevention Care and Treatment, U.S. Agency for International Development, Washington, DC.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Akpan', 'Affiliation': 'Right to Care/EQUIP Health, South Africa.'}, {'ForeName': 'Khotso', 'Initials': 'K', 'LastName': 'Maile', 'Affiliation': 'Right to Care/EQUIP Health, Maseru, Lesotho.'}, {'ForeName': 'Iyiola', 'Initials': 'I', 'LastName': 'Faturiyele', 'Affiliation': 'Division of Prevention Care and Treatment, U.S. Agency for International Development, Washington, DC.'}, {'ForeName': 'Thembi', 'Initials': 'T', 'LastName': 'Xulu', 'Affiliation': 'Right to Care/EQUIP Health, South Africa.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Minior', 'Affiliation': 'Division of Prevention Care and Treatment, U.S. Agency for International Development, Washington, DC.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Sanne', 'Affiliation': 'Right to Care/EQUIP Health, South Africa.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Chasela', 'Affiliation': 'Right to Care/EQUIP Health, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002439']
1133,32671664,"An Investigation of the Skin Barrier Restoring Effects of a Cream and Lotion Containing Ceramides in a Multi-vesicular Emulsion in People with Dry, Eczema-Prone, Skin: The RESTORE Study Phase 1.","INTRODUCTION


The replenishment of skin lipids depleted in the dry skin state is a desirable therapeutic target to restore skin moisturization; however, there is limited evidence demonstrating the success of this approach through the use of topical emollients. The purpose of this study was to provide evidence of the benefits of a cream and equivalent lotion containing skin lipids in a multi-vesicular emulsion for the management of dry skin. The hypothesis was that the test cream and test lotion could sustain skin moisturization for longer than traditional emollients by sustainably delivering skin lipids.
METHODS


A double-blind intra-subject vehicle-controlled single open-application test on the lower legs in people with dry, atopic dermatitis (atopic eczema)-prone, skin was conducted. There were six treatment sites, three per lower leg in each participant, which were treated with the test cream, the test lotion, three reference creams commonly prescribed in the UK and no treatment as a control. After baseline measurements of skin hydration, 100 μl of the test/reference creams was applied to each of the relevant treatment sites (random site allocation). Following treatment, measurements of skin hydration and scoring of visual dryness was conducted at timed intervals (3, 6, 12 and 24 h post-product application).
RESULTS


The test cream and lotion both significantly increased skin hydration and reduced skin dryness for at least 24 h following a single application compared to a no treatment control site. Compared to three reference emollient creams the test cream and test lotion were the only products capable of sustaining clinically meaningful improvements in skin moisturization for 24 h.
CONCLUSION


The sustained moisturization imparted by the test products reduces the need for frequent emollient application, often requiring 3-4 applications per day for traditional emollients, and should reduce the high burden of managing dry skin conditions like atopic dermatitis.",2020,The test cream and lotion both significantly increased skin hydration and reduced skin dryness for at least 24 h following a single application compared to a no treatment control site.,"['People with Dry, Eczema-Prone, Skin', 'people with dry, atopic dermatitis (atopic eczema)-prone, skin was conducted', 'dry skin']","['cream and equivalent lotion containing skin lipids', 'Cream and Lotion Containing Ceramides', 'double-blind intra-subject vehicle-controlled single open-application test']","['skin hydration and scoring of visual dryness', 'skin hydration and reduced skin dryness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}]","[{'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}]",,0.0643835,The test cream and lotion both significantly increased skin hydration and reduced skin dryness for at least 24 h following a single application compared to a no treatment control site.,"[{'ForeName': 'Simon G', 'Initials': 'SG', 'LastName': 'Danby', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK. s.danby@sheffield.ac.uk.'}, {'ForeName': 'Paul V', 'Initials': 'PV', 'LastName': 'Andrew', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Brown', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chittock', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Kay', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Cork', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}]",Dermatology and therapy,['10.1007/s13555-020-00426-3']
1134,32677216,A randomized controlled trial of internet-delivered cognitive behaviour therapy for adolescent anxiety disorders in a routine clinical care setting with and without parent sessions.,"BACKGROUND


Computerized treatments have been shown to be effective in young people with anxiety disorders within research settings. The aims of this study were to evaluate a self-completed, therapist-supported online treatment for adolescent anxiety disorders in a routine clinical care setting and examine whether additional sessions for parents improved treatment outcome.
METHOD


Sixty adolescents (13-18 years) referred by primary and secondary care services for treatment of an anxiety disorder and their parent(s) were randomly allocated to begin treatment immediately or after a 16-week waitlist. Half the parents (receiving treatment immediately or after a waitlist) were allocated to receive sessions themselves. Assessments were conducted pre- and posttreatment and at 6-month follow-up.
RESULTS


There was no significant difference posttreatment between the immediate treatment and waitlist groups in remission of primary anxiety disorder (Odds Ratio (OR) = 2.19, 95% CI: 0.72-6.70). Parent sessions did not significantly improve adolescent outcomes immediately or at 6-month follow-up (OR = 0.75, 95% CI: 0.26-2.15; OR = 1.14, 95% CI: 0.42-3.15).
CONCLUSIONS


Within a routine clinical care setting, a therapist-supported online treatment failed to deliver significantly better outcomes for adolescents with anxiety disorders than a waitlist. Further research is needed to develop more effective treatments for this population.",2019,"Parent sessions did not significantly improve adolescent outcomes immediately or at 6-month follow-up (OR = 0.75, 95% CI: 0.26-2.15; OR = 1.14, 95% CI: 0.42-3.15).
","['adolescent anxiety disorders', 'Sixty adolescents (13-18\xa0years) referred by primary and secondary care services for treatment of an anxiety disorder and their parent(s', 'adolescent anxiety disorders in a routine clinical care setting with and without parent sessions', 'young people with anxiety disorders within research settings', 'adolescents with anxiety disorders']","['therapist-supported online treatment', 'internet-delivered cognitive behaviour therapy']","['adolescent outcomes', 'remission of primary anxiety disorder']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0553514', 'cui_str': 'Referral source'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]",,0.0586422,"Parent sessions did not significantly improve adolescent outcomes immediately or at 6-month follow-up (OR = 0.75, 95% CI: 0.26-2.15; OR = 1.14, 95% CI: 0.42-3.15).
","[{'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Waite', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK.'}, {'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'Marshall', 'Affiliation': 'CAMHS Anxiety & Depression Pathway, Berkshire Healthcare Foundation Trust, School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Creswell', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK.'}]",Child and adolescent mental health,['10.1111/camh.12311']
1135,32673215,Sun Safe Partners Online: Pilot Randomized Controlled Clinical Trial.,"BACKGROUND


Harnessing supportive influences in close relationships is an innovative and potentially effective strategy to improve sun protection behaviors.
OBJECTIVE


This pilot randomized controlled clinical trial evaluates the feasibility and impact of Sun Safe Partners Online, a web-based, couples-focused intervention to improve sun protection behavior.
METHODS


A total of 75 couples reporting suboptimal levels of sun protection recruited from Facebook advertisements were randomized to receive a web-based intervention called Sun Safe Partners Online or a Generic Online Sun Safety Information intervention. Sun Safe Partners Online had 4 individual-focused modules and 4 couples-focused modules. Feasibility was assessed by study enrollment, engagement, follow-up survey completion, and intervention evaluation. Participants completed baseline and a 1-month postintervention survey assessing sun protection and exposure, along with individual and relationship attitudes about the importance of sun protection.
RESULTS


Using Facebook as a recruitment strategy resulted in rapid enrollment and higher acceptance than for the prior telephone and print trial. The follow-up survey completion was higher in the Generic Online condition (100%) than in the Sun Safe Partners Online condition (87.2%). Engagement in Sun Safe Partners Online was high, with more than two-thirds of participants completing all modules. Evaluations of Sun Safe Partners Online content and features as well as ease of navigation were excellent. Sun Safe Partners Online showed small effects on sun protection behaviors and sun exposure on weekends compared with the Generic Online intervention and moderate effect size increases in the Sun Safe Partners Online condition.
CONCLUSIONS


This study uses a novel approach to facilitate engagement in sun protection by harnessing the influence of relationships among spouses and cohabiting partners. A couples-focused intervention may hold promise as a means to improve sun protection behaviors beyond interventions focused solely on individuals by leveraging the concern, collaboration, and support among intimate partners and addressing relationship-based barriers to sun protection.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04549675; https://clinicaltrials.gov/ct2/show/NCT04549675.",2020,"Sun Safe Partners Online showed small effects on sun protection behaviors and sun exposure on weekends compared with the Generic Online intervention and moderate effect size increases in the Sun Safe Partners Online condition.
","['Sun Safe Partners Online', 'spouses and co-habiting partners', 'Seventy five couples reporting suboptimal levels of sun protection recruited from Facebook advertisements']","['web-based intervention called Sun Safe Partners Online or a Generic Online Sun Safety Information intervention', 'Sun Safe Partners Online, an online, couple-focused intervention']",[],"[{'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]",[],75.0,0.170333,"Sun Safe Partners Online showed small effects on sun protection behaviors and sun exposure on weekends compared with the Generic Online intervention and moderate effect size increases in the Sun Safe Partners Online condition.
","[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Manne', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc, Golden, CO, United States.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Devine', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, United States.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Heckman', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, United States.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Pagoto', 'Affiliation': 'University of Connecticut, Storrs, CT, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Frederick', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, United States.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mitarotondo', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, United States.'}]",Journal of medical Internet research,['10.2196/18037']
1136,33068669,"The effect of transcranial direct current stimulation (tDCS) on food craving, reward and appetite in a healthy population.","The ability to control hedonic appetite is associated with executive functioning originating in the prefrontal cortex (PFC). The rewarding components of food can override homeostatic mechanisms, potentiating obesogenic behaviours. Indeed, those susceptible to overconsumption appear to have PFC hypo-activation. Transcranial direct current stimulation (tDCS) over the dorsolateral PFC (DLPFC) has been shown to reduce food craving and consumption, potentially via attenuating this reward response. We examined the effects of stimulation on food reward and craving using a healthy-weight cohort. This study is amongst the first to explore the effects of tDCS on explicit and implicit components of reward for different food categories. Twenty-one healthy-weight participants (24 ± 7 years, 22.8 ± 2.3 kg·m -2 ) completed two sessions involving double-blind, randomised and counterbalanced anodal or sham tDCS over the right DLPFC, at 2 milliampere for 20 minutes. Food craving (Food Craving Questionnaire-State), reward (Leeds Food Preference Questionnaire), and subjective appetite (100 mm visual analogue scales) were measured pre- and post-tDCS. Eating behaviour trait susceptibility was assessed using the Three Factor Eating Questionnaire-Short Form, Control of Eating Questionnaire, and Food Craving Questionnaire-Trait-reduced. Stimulation did not alter food craving, reward or appetite in healthy-weight participants who displayed low susceptibility to overconsumption, with low trait craving, good craving control, and low uncontrolled eating and emotional eating behaviour. Implicit and explicit reward were reliable measures of hedonic appetite, suggesting these are robust targets for future tDCS research. These findings suggest that applying tDCS over the DLPFC does not change food reward response in individuals not at risk for overconsumption, and future work should focus on those at risk of overconsumption who may be more responsive to the effects of tDCS on hedonic appetite.",2020,"Stimulation did not alter food craving, reward or appetite in healthy-weight participants who displayed low susceptibility to overconsumption, with low trait craving, good craving control, and low uncontrolled eating and emotional eating behaviour.","['healthy-weight cohort', 'healthy population', 'Twenty-one healthy-weight participants (24 ± 7 years, 22.8 ± 2.3 kg·m -2 ', 'healthy-weight participants who displayed low susceptibility to overconsumption, with low trait craving, good craving control, and low uncontrolled eating and emotional eating behaviour']","['Transcranial direct current stimulation (tDCS', 'dorsolateral PFC (DLPFC', 'transcranial direct current stimulation (tDCS', 'counterbalanced anodal or sham tDCS', 'tDCS']","['food reward and craving', 'Factor Eating Questionnaire-Short Form, Control of Eating Questionnaire, and Food Craving Questionnaire-Trait-reduced', 'Food craving (Food Craving Questionnaire-State), reward (Leeds Food Preference Questionnaire), and subjective appetite (100 mm visual analogue scales', 'hedonic appetite', 'food craving, reward and appetite', 'Eating behaviour trait susceptibility', 'food craving, reward or appetite']","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C2983598', 'cui_str': 'Dorsolateral'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]",21.0,0.0334459,"Stimulation did not alter food craving, reward or appetite in healthy-weight participants who displayed low susceptibility to overconsumption, with low trait craving, good craving control, and low uncontrolled eating and emotional eating behaviour.","[{'ForeName': 'Jordan D', 'Initials': 'JD', 'LastName': 'Beaumont', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, LS18 5HD, UK. Electronic address: j.beaumont@leedstrinity.ac.uk.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Davis', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, LS18 5HD, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Dalton', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, LS18 5HD, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nowicky', 'Affiliation': 'Centre for Cognitive Neuroscience, Department of Clinical Sciences, College of Health and Life Sciences, Brunel University London, Uxbridge, UB8 3PH, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Russell', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, LS18 5HD, UK.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Barwood', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, LS18 5HD, UK.'}]",Appetite,['10.1016/j.appet.2020.105004']
1137,33068691,Resveratrol and exercise combined to treat functional limitations in late life: A pilot randomized controlled trial.,"PURPOSE


To evaluate the safety and feasibility of combining exercise (EX) and resveratrol to treat older adults with physical function limitations.
METHODS


Three-arm, two-site pilot randomized, controlled trial (RCT) for community-dwelling adults (N = 60), 71.8 ± 6.3 years of age with functional limitations. Participants were randomized to receive either 12 weeks of (1) EX + placebo [EX0], (2) EX + 500 mg/day resveratrol [EX500], or (3) EX + 1000 mg/day resveratrol [EX1000]. EX consisted of two sessions a week for 12 weeks of center-based walking and whole-body resistance training. Safety was assessed through adverse events and feasibility through exercise session and supplement (placebo, or resveratrol) protocol adherence. Outcome measures included a battery of indices of physical function as well as skeletal muscle mitchondrial function. Data were adjusted for age and gender using the Intent-To-Treat approach.
RESULTS


Adverse event frequency and type were similar between groups (n = 8 EX0, n = 12 EX500, and n = 7 EX1000). Overall, 85% of participants met the supplement adherence via pill counts while 82% met the exercise session adherence. Adjusted within group mean differences (95% confidence interval) from week 0 to 12 for gait speed ranged from -0.04 (EX0: -0.1, 0.03) m/s to 0.04 (EX1000: -0.02, 0.11) and the six-minute walk test mean differences were 9.45 (EX0: -9.02, 27.7), 22.9 (EX500: 4.18, 41.6), and 33.1 (EX1000: 13.8, 52.4) meters. Unadjusted mean differences for citrate synthase were -0.80 (EX0: -15.45, 13.84), -1.38 (EX500: -12.16, 9.39), and 7.75 (EX1000: -4.68, 20.18) mU/mg. COX activity mean within group changes ranged from -0.05 (EX0) to 0.06 (EX500) k/s/mg. Additional outcomes are detailed in the text.
CONCLUSION


The pilot RCT indicated that combined EX + resveratrol was safe and feasible for older adults with functional limitations and may improve skeletal muscle mitochondrial function and mobility-related indices of physical function. A larger trial appears warranted and is needed to formally test these hypotheses.",2020,the six-minute walk test mean differences were 9.45,"['older adults with physical function limitations', 'late life', 'older adults with functional limitations', 'community-dwelling adults (N\u202f=\u202f60), 71.8\u202f±\u202f6.3\u202fyears of age with functional limitations']","['Resveratrol and exercise combined', 'EX + placebo [EX0], (2) EX + 500\u202fmg/day resveratrol [EX500], or (3) EX + 1000\u202fmg/day resveratrol [EX1000', 'combined EX + resveratrol', 'exercise session and supplement (placebo, or resveratrol) protocol adherence', 'combining exercise (EX']","['citrate synthase', 'battery of indices of physical function as well as skeletal muscle mitchondrial function', 'supplement adherence via pill counts', 'COX activity mean']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C0008855', 'cui_str': 'Citrate(si)-synthase'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.205006,the six-minute walk test mean differences were 9.45,"[{'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Harper', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; Kinesiology and Health Science Department, Utah State University, Logan, UT, USA; Sorenson Legacy Foundation Center for Clinical Excellence, Utah State University, Logan, UT, USA. Electronic address: sara.harper@usu.edu.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Bassler', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, AL, USA. Electronic address: jbassle1@uab.edu.'}, {'ForeName': 'Sujitha', 'Initials': 'S', 'LastName': 'Peramsetty', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; Integrative Center for Aging Research, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: gperam@uab.edu.'}, {'ForeName': 'Youfeng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; Integrative Center for Aging Research, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: youfengyang@uabmc.edu.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Roberts', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; Integrative Center for Aging Research, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: lmroberts@uabmc.edu.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Drummer', 'Affiliation': 'Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; Department of Cell, Developmental and Integrative Biology, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: drummerd@uab.edu.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Mankowski', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA. Electronic address: r.mankowski@uflu.edu.'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'Leeuwenburgh', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA. Electronic address: cleeuwen@flu.edu.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Ricart', 'Affiliation': 'Department of Pathology, University of Alabama at Birmingham, Birmingham, AL, USA; Center for Free Radical Biology, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: karinaricart@uabmc.edu.'}, {'ForeName': 'Rakesh P', 'Initials': 'RP', 'LastName': 'Patel', 'Affiliation': 'Department of Pathology, University of Alabama at Birmingham, Birmingham, AL, USA; Center for Free Radical Biology, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: rakeshpatel@uabmc.edu.'}, {'ForeName': 'Marcas M', 'Initials': 'MM', 'LastName': 'Bamman', 'Affiliation': 'Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; Department of Cell, Developmental and Integrative Biology, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: mbamman@uab.edu.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Anton', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA. Electronic address: santon@ufl.edu.'}, {'ForeName': 'Byron C', 'Initials': 'BC', 'LastName': 'Jaeger', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, AL, USA. Electronic address: bcjaeger@uab.edu.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Buford', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; Integrative Center for Aging Research, University of Alabama at Birmingham, Birmingham, AL, USA; UAB Nathan Shock Center on the Basic Biology of Aging, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: twbuford@uabmc.edu.'}]",Experimental gerontology,['10.1016/j.exger.2020.111111']
1138,33068707,Feasibility trial of cognitive behavioural therapy for fatigue in haemodialysis (BReF intervention).,"OBJECTIVE


Fatigue affects at least half of patients who are on haemodialysis with considerable repercussions on their functioning, quality of life, and clinical outcomes. This study assessed the feasibility, acceptability, and potential benefits of a cognitive-behavioural therapy (CBT) intervention for fatigue (BReF intervention).
METHODS


This was a feasibility randomised-controlled trial of the BReF intervention versus waiting-list control. Outcomes included recruitment, retention, and adherence rates. Exploratory estimates of treatment effect were computed. The statistician was blinded to allocation.
RESULTS


Twenty-four prevalent haemodialysis patients experiencing clinical levels of fatigue were individually randomised (1:1) to BReF (N=12) or waiting-list control arms (N=12). 53 (16.6% 95% CI 12.7% to 21.1%) out of 320 patients approached consented and completed the screening questionnaire. It was necessary to approach 13 patients for screening for every 1 patient randomised. The rate of retention at follow-up was 75% (95% CI 53.29% to 90.23%). Moderate to large treatment effects were observed in favour of BReF on fatigue severity, fatigue-related functional impairment, depression, and anxiety SMD g= 0.81, SMD g= 0.93, SMD g= 0.38, SMD g= 0.42, respectively), but not sleep quality (SMD g =-0.31). No trial adverse events occurred.
CONCLUSION


There was promising evidence in support of the need and benefits of a CBT-based intervention for fatigue in haemodialysis. However, uptake was low, possibly as a result of an already high treatment burden in this setting. Considerations on the context of delivery are necessary before pursuing a definitive trial.",2020,"Moderate to large treatment effects were observed in favour of BReF on fatigue severity, fatigue-related functional impairment, depression, and anxiety SMD g= 0.81, SMD g= 0.93, SMD g= 0.38, SMD g= 0.42, respectively), but not sleep quality (SMD g =-0.31).","['fatigue in haemodialysis (BReF intervention', 'Twenty-four prevalent haemodialysis patients experiencing clinical levels of fatigue', '53']","['cognitive-behavioural therapy (CBT) intervention', 'BReF intervention versus waiting-list control', 'cognitive behavioural therapy', 'CBT-based intervention', 'BReF']","['recruitment, retention, and adherence rates', 'fatigue severity, fatigue-related functional impairment, depression, and anxiety SMD', 'sleep quality', 'rate of retention']","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4759767', 'cui_str': 'Spondylometaphyseal dysplasia'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",320.0,0.171225,"Moderate to large treatment effects were observed in favour of BReF on fatigue severity, fatigue-related functional impairment, depression, and anxiety SMD g= 0.81, SMD g= 0.93, SMD g= 0.38, SMD g= 0.42, respectively), but not sleep quality (SMD g =-0.31).","[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Picariello', 'Affiliation': ""Health Psychology Section, Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK. Electronic address: federica.picariello@kcl.ac.uk.""}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""Health Psychology Section, Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Norton', 'Affiliation': ""Health Psychology Section, Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Iain C', 'Initials': 'IC', 'LastName': 'Macdougall', 'Affiliation': ""Department of Renal Medicine, King's College Hospital, London, UK.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Da Silva-Gane', 'Affiliation': 'Department of Renal Medicine, Lister Hospital, Stevenage, UK; University of Hertfordshire, Hertfordshire, UK.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Farrington', 'Affiliation': 'Department of Renal Medicine, Lister Hospital, Stevenage, UK; University of Hertfordshire, Hertfordshire, UK.'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Clayton', 'Affiliation': 'Department of Renal Medicine, Lister Hospital, Stevenage, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Chilcot', 'Affiliation': ""Health Psychology Section, Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK. Electronic address: joseph.chilcot@kcl.ac.uk.""}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.10.005']
1139,33068751,Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder: Cognitive and Electrophysiological Predictors of Treatment Response.,"OBJECTIVE


The current study applies a precision medicine approach to Trigeminal Nerve Simulation (TNS), an FDA approved, neuromodulation treatment for attention-deficit/hyperactivity disorder (ADHD) by testing secondary outcomes of cognitive and electrophysiological (EEG) predictors of treatment response among subjects from the original randomized controlled trial.
METHOD


Children aged 8-12 years with ADHD, were randomized to four weeks of active or sham TNS treatment; after which, the sham group crossed over into four weeks of open-label treatment. TNS treatment responders (RESP) had an ADHD Rating Scale (ADHD-RS) Total score reduction of >25%, while non-responders (NR) had <25% reduction post-treatment. Assessments included weekly behavioral ratings and pre-/post-treatment cognitive and EEG measures.
RESULTS


The final sample was 25 RESP and 26 NR (34 male children, mean age 10.3 (1.4) years). Baseline measures that significantly differentiated RESP from NR include: lower working memory, lower spelling and math achievement, deficits on behavioral ratings of executive function (BRIEF), and lower resting state EEG power in the right frontal (F4) region (all p's <.05). Compared to NRs, responders showed significantly increased right frontal EEG power with TNS treatment, which was predictive of improved executive functions and ADHD symptomatology (β=.65, p<.001). When EEG and behavior were modeled together, the area under the curve (AUC) for BRIEF Working Memory scale was .83 (p=.003), indicating moderate prediction of treatment response.
CONCLUSION


show modulation of right frontal brain activity, improved/normalized executive functions, and ADHD symptom reduction.",2020,"Baseline measures that significantly differentiated RESP from NR include: lower working memory, lower spelling and math achievement, deficits on behavioral ratings of executive function (BRIEF), and lower resting state EEG power in the right frontal (F4) region (all p's <.05).","['subjects from the original randomized controlled trial', 'The final sample was 25 RESP and 26 NR (34 male children, mean age 10.3 (1.4) years', 'Children aged 8-12 years with ADHD']","['active or sham TNS', 'Trigeminal Nerve Simulation (TNS']","['right frontal EEG power', 'ADHD Rating Scale (ADHD-RS', 'normalized executive functions, and ADHD symptom reduction', 'weekly behavioral ratings and pre-/post-treatment cognitive and EEG measures', 'working memory, lower spelling and math achievement, deficits on behavioral ratings of executive function (BRIEF), and lower resting state EEG power in the right frontal (F4) region', 'area under the curve (AUC) for BRIEF Working Memory scale', 'executive functions and ADHD symptomatology', 'Total score reduction']","[{'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}]","[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",34.0,0.0251203,"Baseline measures that significantly differentiated RESP from NR include: lower working memory, lower spelling and math achievement, deficits on behavioral ratings of executive function (BRIEF), and lower resting state EEG power in the right frontal (F4) region (all p's <.05).","[{'ForeName': 'Sandra K', 'Initials': 'SK', 'LastName': 'Loo', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at UCLA, Los Angeles, California. Electronic address: sloo@mednet.ucla.edu.'}, {'ForeName': 'Giulia C', 'Initials': 'GC', 'LastName': 'Salgari', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Ellis', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cowen', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Dillon', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'McGough', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at UCLA, Los Angeles, California.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.09.021']
1140,33069063,Reliability of ultrasound measurement for isolated control of the transversus abdominis muscle during abdominal hollowing: A secondary analysis.,"Ultrasonography (US) measurements of the transversus abdominis muscle (TrA) during abdominal hollowing (AH) are conducted at the maximum AH, which would be unable to evaluate isolated control of the TrA to the internal or external oblique muscles (outer muscles). The present study aimed to establish a reliable method to evaluate the skills of isolated control of the TrA to the outer muscles using US. The datasets of two follow-ups were analyzed with 1-week interval of a wait-and-see control group comprising 20 participants with LBP in a randomized controlled trial. The primary measures were; % change in the thickness of the TrA at 1 cm lateral to the muscle-fascia junction of the TrA, and changes in horizontal distance of the superior edge of the TrA fascia. The measurement time points were immediately before AH during resting and when outer muscle thickness above 1 cm lateral to the muscle-fascia junction of the TrA increased by 10%. Consequently, five repetitions were required to obtain a stable mean value and good reliability (intraclass correlation coefficient [ICC] (1,5)  = 0.65-0.68 for the % change, and 0.84-0.88 for the change in horizontal distance; ICC (2,5)  = 0.82 for the % change, and 0.93 for the change in horizontal distance).",2020,The present study aimed to establish a reliable method to evaluate the skills of isolated control of the TrA to the outer muscles using US.,[],"['ICC', 'Ultrasonography (US) measurements of the transversus abdominis muscle (TrA) during abdominal hollowing (AH']","['thickness of the TrA at 1\xa0cm lateral to the muscle-fascia junction of the TrA, and changes in horizontal distance of the superior edge of the TrA fascia']",[],"[{'cui': 'C0242349', 'cui_str': 'Immunocytochemical procedure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0224378', 'cui_str': 'Structure of transversus abdominis muscle'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}]",20.0,0.0294516,The present study aimed to establish a reliable method to evaluate the skills of isolated control of the TrA to the outer muscles using US.,"[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takasaki', 'Affiliation': 'Department of Physical Therapy, Saitama Prefectural University, Koshigaya, Saitama, Japan. Electronic address: physical.therapy.takasaki@gmail.com.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Kawazoe', 'Affiliation': 'Department of Physical Therapy, Saitama Prefectural University, Koshigaya, Saitama, Japan.'}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2020.102476']
1141,33069106,Brief mindfulness training for smoking cessation in Chinese women in workplaces: A pilot randomized controlled trial.,"INTRODUCTION


Mindfulness training (MT) has shown preliminary efficacy as a behavioral treatment for smoking cessation. We examined the effect of a brief-MT intervention on smoking cessation for Chinese women in workplaces in Hong Kong, China.
METHODS


In this pilot randomized controlled trial, 213 daily smokers were recruited from workplaces and computer-randomized into the intervention (n = 114) or control (n = 99) groups. Participants in both groups received a self-help booklet. Participants in the intervention group additionally attended 2 sessions of a brief-MT workshop. The primary outcome was self-reported 7-day point-prevalence abstinence (PPA) at 6 months. Secondary outcomes were biochemically validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/mL) and smoking reduction at 6 months. Analyses were done by intention to treat. We conducted a post-trial qualitative evaluation on participants in the intervention group (n = 14). Data were analyzed thematically.
RESULTS


At 6-month follow-up, self-reported 7-day PPA were similar between the intervention and control groups (18.4% vs. 21.2%; P = 0.61). Very few participated in biochemical validation (n = 17), and validated abstinence and smoking reduction rates showed no significant difference (5.3% vs. 11.1%, P = 0.12 and 20.2% vs. 20.2%, P = 1.00, respectively). A posteriori analysis showed that brief-MT participants who were psychologically engaged with the intervention had greater 6-month PPA. Qualitative evaluation showed brief-MT reduced stress but its effectiveness was restrained by the insufficient home practice.
CONCLUSIONS


This pilot trial on a brief-MT intervention for smoking cessation on Chinese women in workplaces showed feasibility, but improving compliance is needed to maximize the efficacy in future fully powered trials.",2020,"At 6-month follow-up, self-reported 7-day PPA were similar between the intervention and control groups (18.4% vs. 21.2%; P = 0.61).","['Chinese women in workplaces', 'participants in the intervention group (n\xa0=\xa014', 'Chinese women in workplaces in Hong Kong, China', '213 daily smokers were recruited from workplaces and computer-randomized into the intervention (n\xa0=\xa0114) or control (n\xa0=\xa099) groups']","['self-help booklet', 'Mindfulness training (MT', 'MT intervention', 'brief-MT intervention', 'Brief mindfulness training']","['validated abstinence and smoking reduction rates', 'smoking reduction', '6-month PPA', 'smoking cessation', '7-day PPA', 'self-reported 7-day point-prevalence abstinence (PPA', 'salivary cotinine']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}]",213.0,0.102459,"At 6-month follow-up, self-reported 7-day PPA were similar between the intervention and control groups (18.4% vs. 21.2%; P = 0.61).","[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Tzu Tsun', 'Initials': 'TT', 'LastName': 'Luk', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Oi Sze', 'Initials': 'OS', 'LastName': 'Lau', 'Affiliation': 'The Lok Sin Tong Benevolent Society Kowloon, Hong Kong SAR, China.'}, {'ForeName': 'Yi Nam', 'Initials': 'YN', 'LastName': 'Suen', 'Affiliation': 'Department of Psychiatry, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Jung Jae', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'William Ho-Cheung', 'Initials': 'WH', 'LastName': 'Li', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Jojo Yan Yan', 'Initials': 'JYY', 'LastName': 'Kwok', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China. Electronic address: mpwang@hku.hk.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106677']
1142,33069109,Behavioral modification decreases approach bias in young adults with internet gaming disorder.,"BACKGROUND


One of the key symptoms of Internet gaming disorder is the impulsive pursuit of Internet games, which causes individuals with this disorder to have a tendency to approach gaming cues. Dual processing theory states that this approach bias is caused by the suppression of reflective processing and the hyperactivity of impulsive processing. Therefore, reverse modification training for approach bias can suppress impulsive processing, thereby reducing or treating the disorder.
METHOD


In this study, 48 individuals with Internet gaming disorder were selected and randomly assigned to the following two groups: the experimental group and the control group. The 24 participants in the experimental group received a 4-day stimulus-response compatibility (SRC) approach bias modification treatment, whereas the 24 participants in the control group received a corresponding SRC pseudomodification training.
RESULTS


The approach response time of both groups to the gaming cues was significantly shorter than that to the neutral cues at baseline. After the modification, the response time of the experimental group to the gaming cues significantly increased, whereas the scores for Internet gaming disorder severity, anxiety level and craving significantly decreased. However, the control group subjects did not show these effects.
CONCLUSION


The current results imply that individuals with Internet gaming disorder show approach bias toward Internet gaming cues, and SRC reverse modification training can significantly correct this bias and therefore have therapeutic effects to some extent.",2020,"After the modification, the response time of the experimental group to the gaming cues significantly increased, whereas the scores for Internet gaming disorder severity, anxiety level and craving significantly decreased.","['young adults with internet gaming disorder', 'individuals with Internet gaming disorder', '48 individuals with Internet gaming disorder']","['4-day stimulus-response compatibility (SRC) approach bias modification treatment', 'corresponding SRC pseudomodification training', 'Behavioral modification']","['scores for Internet gaming disorder severity, anxiety level and craving', 'response time', 'gaming cues']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4760905', 'cui_str': 'Internet gaming disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4760905', 'cui_str': 'Internet gaming disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",48.0,0.0253849,"After the modification, the response time of the experimental group to the gaming cues significantly increased, whereas the scores for Internet gaming disorder severity, anxiety level and craving significantly decreased.","[{'ForeName': 'Jinbo', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China. Electronic address: hjb@mail.ccnu.edu.cn.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Pan', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Nie', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Suqing', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106686']
1143,33069121,Add-on memantine may improve cognitive functions and attenuate inflammation in middle- to old-aged bipolar II disorder patients.,"OBJECTIVES


Chronic inflammation and neuroprogression underlie bipolar disorder (BP) and associated cognitive deficits. Memantine (MM) exerts neuroprotective effects by reducing neuroinflammation. Therefore, we investigated whether add-on low-dose MM (5 mg/day) in BP-II patients may improve cognition and inflammation.
METHODS


We combined two 12-week randomized, double-blind, placebo-controlled studies (NCT01188148 and NCT03039842) for analysis. Each participant was allocated to the MM or placebo group. Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1 (TGF-β1), and brain-derived neurotrophic factor (BDNF)] were evaluated at baseline and endpoint. A subgroup analysis of middle- to old-aged BP-II patients was also performed.
RESULTS


We recruited 155 BP-II patients (23 of which were middle- to old-aged) for the MM group and 170 patients (20 of which were middle- to old-aged) for the placebo group. Add-on MM did not result in significant improvements in cognitive functions in all BP-II patients, but a group difference in TNF-α levels was found in the MM group (P=0.04). Specifically, in middle- to old-aged BP-II patients, there was a significant time and group interaction effect on omission T-scores, hit reaction time T-scores, and hit reaction time standard error T-scores on continuous performance tests (CPTs) in the MM group (P=0.007, 0.02, and 0.01, respectively), and a decrease in plasma TNF-α levels (P=0.04).
LIMITATIONS


The sample size of middle- to old-aged BP-II patients were limited.
CONCLUSION


Add-on MM may attenuate inflammation in BP-II and improve cognition in middle- to old-aged BP-II patients.",2020,"Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1","['155 BP-II patients (23 of which were middle- to old-aged) for the MM group and 170 patients (20 of which were middle- to old-aged) for the placebo group', 'sample size of middle- to old-aged BP-II patients were limited', 'middle- to old-aged bipolar II disorder patients']","['MM or placebo', 'placebo', 'Memantine (MM', 'memantine']","['TGF-β1), and brain-derived neurotrophic factor (BDNF', 'omission T-scores, hit reaction time T-scores, and hit reaction time standard error T-scores on continuous performance tests (CPTs', 'TNF-α levels', 'cognition and inflammation', 'cognitive functions', 'plasma TNF-α levels', 'Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1']","[{'cui': 'C0236788', 'cui_str': 'Bipolar II disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]","[{'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}]",,0.407349,"Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1","[{'ForeName': 'Ru-Band', 'Initials': 'RB', 'LastName': 'Lu', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Yanjiao Furen Hospital, Hebei, China.'}, {'ForeName': 'Tzu-Yun', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan. Electronic address: wangty@mail.ncku.edu.tw.'}, {'ForeName': 'Sheng-Yu', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Yun-Hsuan', 'Initials': 'YH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychology, Asia University, Taichung, Taiwan; Department of Medical Research, China Medical University Hospital, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Shiou-Lan', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Lipid Science and Aging Research Center, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Tsung-Yu', 'Initials': 'TY', 'LastName': 'Tsai', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Po See', 'Initials': 'PS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Institute of Behavioral Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'San-Yuan', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Nian-Sheng', 'Initials': 'NS', 'LastName': 'Tzeng', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan; Student Counseling Center, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'I Hui', 'Initials': 'IH', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Kao Chin', 'Initials': 'KC', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yen Kuang', 'Initials': 'YK', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Institute of Behavioral Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Psychiatry, Tainan Hospital, Ministry of Health and Welfare, Tainan, Taiwan.'}, {'ForeName': 'Jau-Shyong', 'Initials': 'JS', 'LastName': 'Hong', 'Affiliation': 'Neurobiology Laboratory, NIH/NIEHS, Research Triangle Park, NC, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.003']
1144,32666291,Comparison of middle ear function and hearing thresholds in children with adenoid hypertrophy after microdebrider and conventional adenoidectomy: a randomised controlled trial.,"BACKGROUND


Microdebrider has superior efficacy in clearing the adenoids, compared to curettage. We compared the improvement in middle ear function and hearing thresholds after adenoidectomy, by both methods.
MATERIALS AND METHODS


126 patients (median age-9 years) were randomized into groups A and B, where adenoidectomy was done by microdebrider and curettage, respectively. Middle ear function parameters and hearing thresholds were measured serially.
RESULTS


The mean improvement in middle ear pressure, compliance and hearing thresholds were 92.5 ± 67.6 and 84.2 ± 71.4 daPa; (p = 0.40), 0.19 ± 0.34 and 0.27 ± 0.27 mL; (p = 0.07) and 3.20 ± 4.95 and 2.54 ± 3.98 dB; (p = 0.27), in groups A and B, respectively. Reversal of type B tympanograms was noted in both groups.
CONCLUSIONS


Middle ear function and hearing thresholds improved in both groups after adenoidectomy. More improvement was noted in the microdebrider group, which, however, was not significant.",2020,Middle ear function and hearing thresholds improved in both groups after adenoidectomy.,"['children with adenoid hypertrophy after microdebrider and', '126 patients (median age-9\xa0years']",['conventional adenoidectomy'],"['Middle ear function parameters and hearing thresholds', 'middle ear function and hearing thresholds', 'mean improvement in middle ear pressure, compliance and hearing thresholds', 'Middle ear function and hearing thresholds']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0149825', 'cui_str': 'Hypertrophy of adenoids'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}]","[{'cui': 'C0457585', 'cui_str': 'Middle ear function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0234732', 'cui_str': 'Threshold of hearing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0457587', 'cui_str': 'Middle ear pressure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",126.0,0.110676,Middle ear function and hearing thresholds improved in both groups after adenoidectomy.,"[{'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Rajan', 'Affiliation': 'Department of Otorhinolaryngology, All India Institute of Medical Sciences, Jodhpur, 342005, India. rajannikhil3@gmail.com.'}, {'ForeName': 'Sunil Kumar', 'Initials': 'SK', 'LastName': 'Saxena', 'Affiliation': 'Department of Otorhinolaryngology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Pradipta Kumar', 'Initials': 'PK', 'LastName': 'Parida', 'Affiliation': 'Department of Otorhinolaryngology, All India Institute of Medical Sciences, Bhubaneswar, India.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Alexander', 'Affiliation': 'Department of Otorhinolaryngology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Sivaraman', 'Initials': 'S', 'LastName': 'Ganesan', 'Affiliation': 'Department of Otorhinolaryngology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06197-z']
1145,32675772,Brief Report: Durable Suppression and Low Rate of Virologic Failure 3 Years After Switch to Dolutegravir + Rilpivirine 2-Drug Regimen: 148-Week Results From the SWORD-1 and SWORD-2 Randomized Clinical Trials.,"BACKGROUND


The SWORD trials showed that in participants who achieved virologic suppression taking 3-drug or 4-drug regimens, switching to the 2-drug regimen dolutegravir plus rilpivirine was noninferior in maintaining HIV-1 RNA <50 copies/mL at the week 48 primary endpoint. We present pooled week 148 analysis results from both studies.
SETTING


SWORD-1: 65 centers, 13 countries; SWORD-2: 60 centers, 11 countries.
METHODS


SWORD-1 and SWORD-2 are identical, open-label, phase III studies. Participants with screening HIV-1 RNA <50 copies/mL for ≥6 months; no prior virologic failure; and no documented resistance-associated major protease inhibitor, integrase inhibitor, nucleoside reverse transcriptase inhibitor (NRTI), or non-NRTI mutations or integrase resistance-associated substitution R263K were randomly assigned 1:1 to switch to once-daily dolutegravir 50 mg plus rilpivirine 25 mg on day 1 (early-switch group) or to continue their current antiretroviral regimen and, if virologically suppressed at week 48, switch to dolutegravir plus rilpivirine at week 52 (late-switch group) until week 148.
RESULTS


Using snapshot algorithm at week 148, 432 of 513 (84%) early-switch participants (148 weeks of exposure) and 428 of 477 (90%) late-switch participants (96 weeks of exposure) maintained HIV-1 RNA <50 copies/mL. Eleven participants (1%) on dolutegravir plus rilpivirine met the confirmed virologic withdrawal criterion through week 148 (early-switch group, n = 8; late-switch group, n = 3) with no integrase resistance identified. Non-NRTI resistance-associated mutations were identified in 6 participants (<1%). Drug-related adverse events (grades 2-4) were observed in 31 (6%) early-switch and 16 (3%) late-switch participants. Significant improvements in bone biomarkers were observed. Significant improvements were observed in renal biomarkers in participants taking tenofovir disoproxil fumarate pre-switch.
CONCLUSION


Switching to the 2-drug regimen dolutegravir plus rilpivirine maintained virologic suppression for a high proportion of participants through 3 years, with low rates of virologic failure and a well-tolerated safety profile.",2020,"Significant improvements were observed in renal biomarkers in participants taking tenofovir disoproxil fumarate pre-switch.
CONCLUSION


Switching to the 2-drug regimen dolutegravir plus rilpivirine maintained virologic suppression for a high proportion of participants through 3 years, with low rates of virologic failure and a well-tolerated safety profile.","['65 centers, 13 countries; SWORD-2', 'SWORD-1', 'R263K', 'Early-Switch participants (148 weeks of exposure) and 428/477 (90', '60 centers, 11 countries']","['Dolutegravir + Rilpivirine', 'rilpivirine', 'tenofovir disoproxil fumarate', 'dolutegravir 50 mg plus rilpivirine', 'dolutegravir plus rilpivirine']","['virologic failure', 'renal biomarkers', 'Durable Suppression and Low Rate of Virologic Failure', 'virologic suppression', 'bone biomarkers', 'resistance-associated major PI, INI, NRTI, or NNRTI mutations or integrase resistance-associated substitution', 'NNRTI resistance-associated mutations']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0522656', 'cui_str': 'Sword'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C4530989', 'cui_str': 'dolutegravir and rilpivirine'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}]","[{'cui': 'C1699206', 'cui_str': 'Virologic failure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0063690', 'cui_str': 'Integrase'}]",,0.0523723,"Significant improvements were observed in renal biomarkers in participants taking tenofovir disoproxil fumarate pre-switch.
CONCLUSION


Switching to the 2-drug regimen dolutegravir plus rilpivirine maintained virologic suppression for a high proportion of participants through 3 years, with low rates of virologic failure and a well-tolerated safety profile.","[{'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'van Wyk', 'Affiliation': 'Global Medical, ViiV Healthcare, Brentford, United Kingdom.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Centre for Immunobiology, Blizard Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Rubio', 'Affiliation': 'HIV Unit, Department of Internal Medicine, Hospital Universitario 12 de Octubre, UCM, Madrid, Spain.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bogner', 'Affiliation': 'Division of Infectious Diseases, Munich University Hospital, Med IV, Munich, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baker', 'Affiliation': 'East Sydney Doctors, Darlinghurst, Sydney, Australia.'}, {'ForeName': 'Marie-Aude', 'Initials': 'MA', 'LastName': 'Khuong-Josses', 'Affiliation': 'Infectious Disease Unit, CHG-Hôpital Delafontaine, Saint Denis Cedex, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Parks', 'Affiliation': 'Central West Clinical Research, St Louis, MO.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Angelis', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Uxbridge, United Kingdom.'}, {'ForeName': 'Lesley P', 'Initials': 'LP', 'LastName': 'Kahl', 'Affiliation': 'Clinical Development, ViiV Healthcare, Brentford, United Kingdom.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Matthews', 'Affiliation': 'Clinical Development, ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Ruolan', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Clinical Virology, ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Clinical Virology, ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Wynne', 'Affiliation': 'Medicine Development, ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Maria-Claudia', 'Initials': 'MC', 'LastName': 'Nascimento', 'Affiliation': 'Clinical Development, ViiV Healthcare, Brentford, United Kingdom.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Vandermeulen', 'Affiliation': 'Global Regulatory and Compound Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gartland', 'Affiliation': 'Medicine Development, ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Kimberly Y', 'Initials': 'KY', 'LastName': 'Smith', 'Affiliation': 'Research and Development, ViiV Healthcare, Research Triangle Park, NC.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002449']
1146,32679403,"Commentary on Liu, K. et al. (2018). 'Handgrip exercise reduces peripherally-inserted central catheter-related venous thrombosis in patients with solid cancers: A randomized controlled trial'.",,2020,,['patients with solid cancers'],['Handgrip exercise reduces peripherally-inserted central catheter-related venous thrombosis'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}]",[],,0.162369,,"[{'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangxi Medical University, No. 6, Shuangyong Road, 530021 Nanning, Guangxi, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Ying', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangxi Medical University, No. 6, Shuangyong Road, 530021 Nanning, Guangxi, China. Electronic address: yanpingying0116@126.com.'}, {'ForeName': 'Jianpeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, The First Affiliated Hospital of Guangxi Medical University, No. 6, Shuangyong Road, 530021 Nanning, Guangxi, China.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103691']
1147,32679405,A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311.,"PURPOSE


Understanding the role of transoral surgery in oropharyngeal cancer (OPC) requires prospective, randomized multi-institutional data. Meticulous evaluation of surgeon expertise and surgical quality assurance (QA) will be critical to the validity of such trials. We describe a novel surgeon credentialing and QA process developed to support the ECOG-ACRIN Cancer Research Group E3311 (E3311) and report outcomes related to QA.
PATIENTS AND METHODS


E3311 was a phase II randomized clinical trial of transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC. In order to be credentialed to accrue to this trial, surgeons were required to demonstrate active hospital credentials and technique-specific surgical expertise with ≥20 cases of transoral resection for OPC. In addition, 10 paired operative and surgical pathology reports from the preceding 24 months were reviewed by an expert panel. Ongoing QA required <10% rate of positive margins, low oropharyngeal bleeding rates, and accrual of at least one patient per 12 months. Otherwise surgeons were placed on hold and not permitted to accrue until re-credentialed using a new series of transoral resections.
RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers. During QA on E3311, positive final pathologic margins were reported in 19 (3.8%) patients. Grade III/IV and grade V oropharyngeal bleeding was reported in 29 (5.9%) and 1 (0.2%) of patients.
CONCLUSIONS


We provide proof of concept that a comprehensive credentialing process can support multicenter transoral head and neck surgical oncology trials, with low incidence of positive margins and *grade III/V oropharyngeal bleeding.",2020,"RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","['120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers', 'oropharyngeal cancer (OPC']","['surgeon expertise and surgical quality assurance (QA', 'transoral surgery', 'transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC']","['positive final pathologic margins', 'positive margins, low oropharyngeal bleeding rates', 'Grade III/IV and grade V oropharyngeal bleeding']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0010298', 'cui_str': 'Credentialing'}, {'cui': 'C0030768', 'cui_str': 'Peer review'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",120.0,0.0606723,"RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States. Electronic address: Ferrisrl@upmc.edu.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Flamand', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'F Christopher', 'Initials': 'FC', 'LastName': 'Holsinger', 'Affiliation': 'Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Weinstein', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Joaquin J', 'Initials': 'JJ', 'LastName': 'Garcia', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Hinni', 'Affiliation': 'Mayo Clinic in Arizona, Phoenix, AZ, United States.'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Gross', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Erich M', 'Initials': 'EM', 'LastName': 'Sturgis', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Umamaheswar', 'Initials': 'U', 'LastName': 'Duvvuri', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Méndez', 'Affiliation': 'University of Washington, Seattle, WA, United States.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ridge', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Magnuson', 'Affiliation': 'Florida Hospital Orlando, Celebration, FL, United States.'}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'Higgins', 'Affiliation': 'ECOG-ACRIN Cancer Research Group, Boston, MA, United States.'}, {'ForeName': 'Mihir R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Russel B', 'Initials': 'RB', 'LastName': 'Smith', 'Affiliation': 'University of Nebraska, Omaha, NE, United States.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Karakla', 'Affiliation': 'Sentara Norfolk General Hospital, Norfolk, VA, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Kupferman', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Malone', 'Affiliation': 'UPMC Pinnacle Cancer Center, Harrisburg, PA, United States.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Judson', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Richmon', 'Affiliation': 'Massachusetts Eye and Ear, Harvard University, Boston, MA, United States.'}, {'ForeName': 'Jay O', 'Initials': 'JO', 'LastName': 'Boyle', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Bayon', 'Affiliation': 'University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Bert W', 'Initials': 'BW', 'LastName': ""O'Malley"", 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Enver', 'Initials': 'E', 'LastName': 'Ozer', 'Affiliation': 'The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Giovana R', 'Initials': 'GR', 'LastName': 'Thomas', 'Affiliation': 'University of Miami Leonard Miller School of Medicine, Miami, FL, United States.'}, {'ForeName': 'Wayne M', 'Initials': 'WM', 'LastName': 'Koch', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'R Bryan', 'Initials': 'RB', 'LastName': 'Bell', 'Affiliation': 'Providence Cancer Institute, Portland, OR, United States.'}, {'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'Elin R', 'Initials': 'ER', 'LastName': 'Sigurdson', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104797']
1148,32681922,Fecal Microbiota Transplantation Reduces Symptoms in Some Patients With Irritable Bowel Syndrome With Predominant Abdominal Bloating: Short- and Long-term Results From a Placebo-Controlled Randomized Trial.,"BACKGROUND & AIMS


Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder associated with intestinal dysbiosis. Given the reported promising results of open-label fecal microbiota transplantation (FMT) therapy in patients with predominant abdominal bloating, we studied efficacy of this treatment in a randomized, placebo-controlled trial.
METHODS


Patients with refractory IBS, defined as failure of ≥3 conventional therapies, were randomly assigned to single-dose nasojejunal administration of donor stools (n = 43) or autologous stools (n = 19) in a double-blind study, performed from December 2015 through October 2017, and were followed up for 1 year. IBS-related symptoms were assessed by using a daily symptom diary to determine general abdominal discomfort, abdominal bloating, abdominal pain, and flatulence on a scale of 1-6. Number of daily bowel movements, consistency of the stools, and abdominal circumference were also recorded. Patients completed the IBS-specific quality of life questionnaire. Primary endpoints were improvement of IBS symptoms and bloating at 12 weeks (response). Secondary endpoints were changes in IBS symptom scores and quality of life. Stool samples were collected for microbiota amplicon sequencing. Open-label retransplantation was offered after the trial.
RESULTS


At week 12, 56% of patients given donor stool reported improvement in both primary endpoints compared with 26% of patients given placebo (P = .03). Patients given donor stool had significant improvements in level of discomfort (mean reduction, 19%; median score before FMT, 3.98; range, 2.13-6.00; median score after FMT, 3.1; range, 951.29-5.90), stool frequency (mean reduction, 13%; median score before FMT, 2.10; range, 0.57-14.29; median score after FMT 1.7; range, 0.71-4.29), urgency (mean reduction, 38%; median score before FMT, 0.61; range, 0.00-1.00; median score after FMT, 0.37; range, 0.00-1.00), abdominal pain (mean reduction, 26%; median score before FMT, 3.88; range, 1.57-5.17; median score after FMT, 2.80; range, 1.14-4.94), flatulence (mean reduction, 10%; median score before FMT, 3.42; range, 0.71-6.00; median score after FMT, 3.07; range, 0.79-4.23), and quality of life (mean increase, 16%; median score before FMT 32.6; range, 11-119; median score after FMT, 43.1; range, 32.25-99). A significantly higher proportion of women given donor stool (69%) had a response than men (29%) (P = .01). Fecal samples from responders had higher diversity of microbiomes before administration of donor material than fecal samples from nonresponders (P = .04) and distinct baseline composition (P = .04), but no specific marker taxa were associated with response. After single FMT, 21% of patients given donor stool reported effects that lasted for longer than 1 year compared with 5% of patients given placebo stool. A second FMT reduced symptoms in 67% of patients with an initial response to donor stool but not in patients with a prior nonresponse.
CONCLUSIONS


In a randomized trial of patients with treatment-refractory IBS with predominant bloating, FMT relieved symptoms compared with placebo (autologous transplant), although the effects decreased over 1 year. A second FMT restored the response patients with a prior response. Response was associated with composition of the fecal microbiomes before FMT; this might be used to as a biomarker to select patients for this treatment. ClinicalTrials.gov, Number: NCT02299973.",2020,"Patients given donor stool had significant improvements in level of discomfort (mean reduction of 19%; median score preFMT, 3.98; range, 2.13-6.00; median score post-FMT, 3.1; range, 951.29-5.90), stool frequency (mean reduction of 13%, median score preFMT, 2.10; range, 0.57-14.29; median score postFMT 1.7; range, 0.71-4.29), urgency (mean reduction of 38%; median score preFMT, 0.61; range, 0.00-1.00; median score postFMT, 0.37; range, 0.00-1.00), abdominal pain (mean reduction of 26%; median score preFMT, 3.88; range, 1.57-5.17; median score postFMT, 2.80; range, 1.14-4.94), flatulence (mean reduction of 10%; median score preFMT, 3.42; range, 0.71-6.00; median score postFMT, 3.07; range, 0.79-4.23), and quality of life (mean increase of 16%; median score preFMT 32.6; range, 11-119; median score postFMT, 43.1; range, 32.25-99).","['patients with treatment-refractory IBS with predominant bloating, FMT relieved symptoms compared with', 'Irritable Bowel Syndrome with Predominant Abdominal Bloating', 'Patients with refractory IBS, defined as failure of ≥ 3 conventional therapies', 'patients with predominant abdominal bloating']","['open-label fecal microbiota transplantation (FMT) therapy', 'single-dose nasojejunal administration of donor stools (n=43) or autologous stools', 'Placebo', 'placebo (autologous transplant', 'Fecal Microbiota Transplantation', 'placebo']","['quality of life', 'IBS symptoms and bloating', 'Number of daily bowel movements, consistency of the stools, and the abdominal circumference', 'level of discomfort', 'stool frequency', 'IBS-specific quality of life questionnaire', 'urgency', 'general abdominal discomfort, abdominal bloating, abdominal pain and flatulence', 'flatulence', 'abdominal pain', 'changes in IBS-symptom-scores and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0232487', 'cui_str': 'Abdominal discomfort'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.524345,"Patients given donor stool had significant improvements in level of discomfort (mean reduction of 19%; median score preFMT, 3.98; range, 2.13-6.00; median score post-FMT, 3.1; range, 951.29-5.90), stool frequency (mean reduction of 13%, median score preFMT, 2.10; range, 0.57-14.29; median score postFMT 1.7; range, 0.71-4.29), urgency (mean reduction of 38%; median score preFMT, 0.61; range, 0.00-1.00; median score postFMT, 0.37; range, 0.00-1.00), abdominal pain (mean reduction of 26%; median score preFMT, 3.88; range, 1.57-5.17; median score postFMT, 2.80; range, 1.14-4.94), flatulence (mean reduction of 10%; median score preFMT, 3.42; range, 0.71-6.00; median score postFMT, 3.07; range, 0.79-4.23), and quality of life (mean increase of 16%; median score preFMT 32.6; range, 11-119; median score postFMT, 43.1; range, 32.25-99).","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Holvoet', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, Ghent, Belgium; Faculty of Health Sciences, Ghent University, Ghent, Belgium. Electronic address: tholvoet@hotmail.com.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Joossens', 'Affiliation': 'KU Leuven, Department of Microbiology, Immunology and Transplantation, Rega Institute, Leuven, Belgium; VIB, Center for Microbiology, Leuven, Belgium.'}, {'ForeName': 'Jorge F', 'Initials': 'JF', 'LastName': 'Vázquez-Castellanos', 'Affiliation': 'KU Leuven, Department of Microbiology, Immunology and Transplantation, Rega Institute, Leuven, Belgium; VIB, Center for Microbiology, Leuven, Belgium.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Christiaens', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Lander', 'Initials': 'L', 'LastName': 'Heyerick', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Jerina', 'Initials': 'J', 'LastName': 'Boelens', 'Affiliation': 'Department of Medical Microbiology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Verhasselt', 'Affiliation': 'Department of Medical Microbiology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'van Vlierberghe', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'De Vos', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Raes', 'Affiliation': 'KU Leuven, Department of Microbiology, Immunology and Transplantation, Rega Institute, Leuven, Belgium; VIB, Center for Microbiology, Leuven, Belgium.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'De Looze', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, Ghent, Belgium; Faculty of Health Sciences, Ghent University, Ghent, Belgium.'}]",Gastroenterology,['10.1053/j.gastro.2020.07.013']
1149,32682552,"Evaluation of the intratidal compliance profile at different PEEP levels in children with healthy lungs: a prospective, crossover study.","BACKGROUND


Optimal intraoperative lung protective ventilation (LPV) strategies in young children are largely under-explored. Individualised PEEP levels are likely to contribute to optimal lung protection. We determined optimal PEEP levels in young children during general anaesthesia by evaluating changes in intratidal compliance with varying PEEP.
METHODS


Children aged ≤6 yr were enrolled in this prospective interventional study. After induction of general anaesthesia and neuromuscular block (rocuronium), children were randomly assigned to be mechanically ventilated at each of three PEEP levels for 15 min each: 5, 8, and 12 cm H 2 O PEEP (PEEP 5/8/12 ). Haemodynamic and respiratory data were recorded at each PEEP level. Intratidal volume-compliance was classified into one of six compliance profiles (increasing/decreasing/horizontal [plateau]/increasing-horizontal/horizontal-decreasing/increasing-horizontal-decreasing) at each PEEP level. The primary outcome was intratidal compliance at different PEEP levels.
RESULTS


Forty-seven children were enrolled (40% female; median age: 2.5 yr [0.9-3.7]). Mean airway pressure progressively increased from 7.6 cm H 2 O (0.5) at PEEP 5 , 10.5 cm H 2 O (0.9) at PEEP 8  to 14.3 cm H 2 O (0.5) PEEP 12  (P<0.001). Mean driving pressure was lower at PEEP 12  (6.3 cm H 2 O [1.1]), compared with PEEP 8  (6.5 cm H 2 O [1.1]) and PEEP 5  (7.0 cm H 2 O [1.5]; P=0.004 for trend). Intratidal compliance increased in 31/47 (66%) children at PEEP 5 , but was less likely with PEEP 8  (9/47; 19.1%) and was absent at PEEP 12 . At PEEP 8 , plateaued compliance was most frequent (16/46; 34.8%). At PEEP 12 , decreasing compliance occurred most frequently (32/46; 69.6%).
CONCLUSIONS


Intratidal compliance at different PEEP levels varied widely in young children under general anaesthesia. These data suggest that individualised PEEP levels are required for optimal lung protection in children.
CLINICAL TRIAL REGISTRATION


NCT03533296.",2020,"Mean airway pressure progressively increased from 7.6 cm H 2 O (0.5) at PEEP 5 , 10.5 cm H 2 O (0.9) at PEEP 8  to 14.3 cm","['young children under general anaesthesia', 'young children', 'Forty-seven children were enrolled (40% female; median age: 2.5 yr [0.9-3.7', 'children with healthy lungs', 'Children aged ≤6 yr']","['general anaesthesia and neuromuscular block (rocuronium', 'intraoperative lung protective ventilation (LPV']","['Intratidal compliance', 'Mean airway pressure progressively', 'Haemodynamic and respiratory data', 'Mean driving pressure', 'intratidal compliance at different PEEP levels']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0235062', 'cui_str': 'Induction of neuromuscular blockade'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",47.0,0.0709234,"Mean airway pressure progressively increased from 7.6 cm H 2 O (0.5) at PEEP 5 , 10.5 cm H 2 O (0.9) at PEEP 8  to 14.3 cm","[{'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-Hwan', 'Initials': 'SH', 'LastName': 'Ji', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyung-Chul', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea; Department of Anaesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Jang', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Eun-Hee', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hee-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea; Department of Anaesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea; Department of Anaesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: jintae73@gmail.com.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.06.046']
1150,32682554,Evaluation of an enhanced pulse oximeter auditory display: a simulaion study.,"BACKGROUND


We compared anaesthetists' ability to identify haemoglobin oxygen saturation (SpO 2 ) levels using two auditory displays: one based on a standard pulse oximeter display (varying pitch plus alarm) and the other enhanced with additional sound properties (varying pitch plus tremolo and acoustic brightness) to differentiate SpO 2  ranges.
METHODS


In a counter-balanced crossover study in a simulator, 20 experienced anaesthetists supervised a junior colleague (an actor) managing two airway surgery scenarios: once while using the enhanced auditory display and once while using a standard auditory display. Participants were distracted with other tasks such as paperwork and workplace interruptions, but were required to identify when SpO 2  transitioned between pre-set ranges (target, low, critical) and when other vital signs transitioned out of a target range. They also identified the range once a transition had occurred. Visual displays were available for all monitored vital signs, but the numerical value for SpO 2  was excluded.
RESULTS


Participants were more accurate and faster at detecting transitions to and from the target SpO 2  range when using the enhanced display (100.0%, 3.3 s) than when using the standard display plus alarm (73.2%, 27.4 s) (P<0.001 and P=0.004, respectively). They were also more accurate at identifying the SpO 2  range once a transition had occurred when using the enhanced display (100.0%) than when using the standard display plus alarm (57.1%; P<0.001).
CONCLUSIONS


The enhanced auditory display helps anaesthetists judge SpO 2  levels more effectively than current auditory displays and may facilitate 'eyes-free' monitoring.",2020,"RESULTS


Participants were more accurate and faster at detecting transitions to and from the target SpO 2  range when using the enhanced display (100.0%, 3.3 s) than when using the standard display plus alarm (73.2%, 27.4 s) (P<0.001 and P=0.004, respectively).",[],['anaesthetists supervised a junior colleague (an actor) managing two airway surgery scenarios'],['haemoglobin oxygen saturation (SpO 2 ) levels'],[],"[{'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0651879,"RESULTS


Participants were more accurate and faster at detecting transitions to and from the target SpO 2  range when using the enhanced display (100.0%, 3.3 s) than when using the standard display plus alarm (73.2%, 27.4 s) (P<0.001 and P=0.004, respectively).","[{'ForeName': 'Estrella', 'Initials': 'E', 'LastName': 'Paterson', 'Affiliation': 'School of Psychology, The University of Queensland, St Lucia, Queensland, Australia. Electronic address: estrella.paterson@uqconnect.edu.au.'}, {'ForeName': 'Penelope M', 'Initials': 'PM', 'LastName': 'Sanderson', 'Affiliation': 'School of Psychology, The University of Queensland, St Lucia, Queensland, Australia; School of Information Technology and Electrical Engineering, The University of Queensland, St Lucia, Queensland, Australia; School of Clinical Medicine, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Isaac S', 'Initials': 'IS', 'LastName': 'Salisbury', 'Affiliation': 'School of Psychology, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Felicity P', 'Initials': 'FP', 'LastName': 'Burgmann', 'Affiliation': 'School of Psychology, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Mohamed', 'Affiliation': 'School of Psychology, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Loeb', 'Affiliation': 'School of Psychology, The University of Queensland, St Lucia, Queensland, Australia; Department of Anesthesiology, University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Neil A B', 'Initials': 'NAB', 'LastName': 'Paterson', 'Affiliation': ""School of Clinical Medicine, The University of Queensland, St Lucia, Queensland, Australia; Anaesthesia and Pain Management Services, Queensland Children's Hospital, South Brisbane, Queensland, Australia.""}]",British journal of anaesthesia,['10.1016/j.bja.2020.05.038']
1151,33065817,Utilizing placebos to leverage effects of cognitive-behavioral therapy in patients with depression.,"BACKGROUND


Patients with depression often experience difficulties with completing homework assignments during cognitive-behavioral therapy (CBT). In the present study, we investigated the effects of a specific placebo which aimed at improving the practice of a daily relaxation exercise during a four-week outpatient program.
METHODS


A total of 126 patients diagnosed with major depressive disorder were randomly assigned to one of three groups: 'Coping with Depression' course, 'Coping with Depression' course with additional daily placebo treatment, and waiting-list group. The placebo (sunflower oil) was introduced as a natural medicine to help the patients focus on their inner strengths and to mobilize their bodies' natural healing powers. The placebo was taken orally before the daily relaxation exercise.
RESULTS


The placebo improved homework quantity and quality (both p < .001). The placebo group practiced more often and experienced greater relaxation effects than the no-placebo group. Additionally, the placebo group showed a greater reduction of depression symptoms (p < .001).
LIMITATIONS


The primary limitation of the study is the lack of a psychophysiological measure of relaxation.
CONCLUSIONS


Placebos can be used to leverage CBT effects in patients with depression.",2020,The placebo improved homework quantity and quality (both p < .001).,"['patients with depression', '126 patients diagnosed with major depressive disorder']","['cognitive-behavioral therapy (CBT', 'specific placebo', 'placebo', 'cognitive-behavioral therapy', 'Placebos', ""Coping with Depression' course, 'Coping with Depression' course with additional daily placebo treatment, and waiting-list group"", 'placebo (sunflower oil']","['reduction of depression symptoms', 'leverage CBT effects', 'relaxation effects', 'homework quantity and quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0589414', 'cui_str': 'Homework'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",126.0,0.205786,The placebo improved homework quantity and quality (both p < .001).,"[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Jurinec', 'Affiliation': 'University of Graz, Department of Clinical Psychology, Graz, Austria; Community Health Center Gornja Radgona, Gornja Radgona, Slovenia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schienle', 'Affiliation': 'University of Graz, Department of Clinical Psychology, Graz, Austria. Electronic address: anne.schienle@uni-graz.at.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.087']
1152,33065818,Differential effects of cranial electrotherapy stimulation on changes in anxiety and depression symptoms over time in patients with generalized anxiety disorder.,"BACKGROUND


Cranial electrotherapy stimulation (CES) is a safe and well-tolerated 6-12 week treatment that is clinically and cost effective on both anxiety and depression symptoms resulting in sustained remission of these symptoms at 12 and 24 weeks in generalized anxiety disorder (GAD) patients. The aim of the current report was to explore whether the effectiveness of CES was related to its effects on depression or anxiety over time METHODS: A consecutive sample of 161 eligible patients with GAD was recruited from two publicly funded services in England while they waited for individual cognitive behaviour therapy (CBT) after failing to achieve remission on the GAD-7 with computerised CBT. They received 60 minutes per day Alpha-Stim CES for 6-12 weeks. Outcomes were changes in PHQ-9, GAD-7 score from baseline to 4, 6, 8, 12 and 24 weeks. Latent variable cross-lagged panel analysis permitted an analysis of the differential effects of anxiety and depression with CES treatment over time.
RESULTS


Anxiety at baseline significantly predicted depression at week 4 (standardized regression weight = .40, p<0.001). Depression at week 12 significantly predicted anxiety at week 24 (standardized regression weight = .28, p<0.05).
LIMITATIONS


Not a randomized controlled trial but further analysis of a prospective observational cohort. High rates of loss to follow up by 24 weeks.
CONCLUSION


Sustained effectiveness required a CES response to anxiety symptoms in first 4 weeks and improvement in depression symptoms by 12 weeks.",2020,"Depression at week 12 significantly predicted anxiety at week 24 (standardized regression weight = .28, p<0.05).
","['patients with generalized anxiety disorder', ' A consecutive sample of 161 eligible patients with GAD was recruited from two publicly funded services in England while they waited for individual cognitive behaviour therapy (CBT) after failing to achieve remission on the GAD-7 with computerised CBT']","['CES', 'cranial electrotherapy stimulation', 'Cranial electrotherapy stimulation (CES']","['Depression', 'anxiety', 'PHQ-9, GAD-7 score', 'depression symptoms', 'anxiety and depression symptoms', 'CES response to anxiety symptoms', 'depression or anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0542399', 'cui_str': 'Patient waiting for'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",161.0,0.0584754,"Depression at week 12 significantly predicted anxiety at week 24 (standardized regression weight = .28, p<0.05).
","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Morriss', 'Affiliation': 'Professor of Psychiatry, Institute of Mental Health and NIHR MindTech MTEC, University of Nottingham, Triumph Road, Nottingham, NG7 2TU, United Kingdom. Electronic address: richard.morriss@nottingham.ac.uk.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Price', 'Affiliation': 'Professor/Director Methodology, Measurement and Statistical Analysis, Texas State University, Texas, US.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.006']
1153,33065820,Cognitive behavioral social rhythm group therapy versus present centered group therapy for veterans with posttraumatic stress disorder and major depressive disorder: A randomized controlled pilot trial.,"BACKGROUND


Cognitive Behavioral Social Rhythm Group Therapy (CBSRT) is a chronobiologically-informed group therapy designed to stabilize social rhythms in veterans with comorbid combat-related PTSD and major depressive disorder (MDD). This randomized controlled pilot trial is the first to examine feasibility and preliminary efficacy of group CBSRT as compared to group Present Centered Therapy (PCT), a well-characterized active attention, psychotherapy condition.
METHODS


A total of 43 male veterans with combat-related PTSD, MDD, and disruptions in sleep or daily routine were randomly assigned to CBSRT or PCT. Therapy was provided weekly in a group modality for 12 weeks. Follow-up feasibility and gold-standard PTSD, MDD, and subjective/objective sleep assessments were conducted at post-treatment, 3 months, and 6 months post-treatment.
RESULTS


Feasibility results demonstrated that veterans assigned to CBSRT had higher rates of attendance than veterans assigned to PCT. Both CBSRT and PCT were associated with improvements in PTSD and MDD symptoms, sleep efficiency, and number of awakenings; there were no differences between group therapies on these indices. Veterans in the CBSRT group had a greater reduction in the number of nightmares than veterans in the PCT group.
LIMITATIONS


Preliminary results must be qualified by the small sample size.
CONCLUSIONS


Group CBSRT may be more feasible for veterans than PCT. Both CBSRT and PCT were associated with improvements in psychiatric symptoms with few differences between conditions. CBSRT is a promising new group therapy that may help address the high-rate of PTSD therapy attrition in combat veterans.
CLINICAL TRIAL REGISTRATION


NCT00984698.",2020,"Veterans in the CBSRT group had a greater reduction in the number of nightmares than veterans in the PCT group.
","['veterans with comorbid combat-related PTSD and major depressive disorder (MDD', '43 male veterans with combat-related PTSD, MDD, and disruptions in sleep or daily routine', 'veterans with posttraumatic stress disorder and major depressive disorder']","['Cognitive Behavioral Social Rhythm Group Therapy (CBSRT', 'CBSRT', 'Centered Therapy (PCT', 'CBSRT or PCT', 'Cognitive behavioral social rhythm group therapy']","['number of nightmares', 'PTSD and MDD symptoms, sleep efficiency, and number of awakenings', 'rates of attendance', 'psychiatric symptoms']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0028084', 'cui_str': 'Nightmares'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}]",43.0,0.0336254,"Veterans in the CBSRT group had a greater reduction in the number of nightmares than veterans in the PCT group.
","[{'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Haynes', 'Affiliation': 'Department of Health Promotion Sciences, University of Arizona, Tucson, USA; Department of Psychiatry, University of Arizona, Tucson, USA; Southern Arizona VA Health Care System, Tucson, USA. Electronic address: thaynes@email.arizona.edu.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Burger', 'Affiliation': 'Department of Health Promotion Sciences, University of Arizona, Tucson, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kelly', 'Affiliation': 'Department of Psychiatry, University of Arizona, Tucson, USA; Southern Arizona VA Health Care System, Tucson, USA; Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Emert', 'Affiliation': 'Department of Psychiatry, University of Arizona, Tucson, USA; Biomedical Research Foundation of Southern Arizona, Tucson, USA; Department of Psychology, University of Alabama, Tuscaloosa, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Perkins', 'Affiliation': 'Southern Arizona VA Health Care System, Tucson, USA.'}, {'ForeName': 'M Tracie', 'Initials': 'MT', 'LastName': 'Shea', 'Affiliation': 'Providence VA Medical Center, Rhode Island, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Rhode Island, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.009']
1154,33065822,A tailored online intervention to improve parenting risk and protective factors for child anxiety and depression: Medium-term findings from a randomized controlled trial.,"BACKGROUND


Despite considerable evidence on parenting risk and protective factors for child anxiety and depressive disorders, the development of interventions based on this evidence is still lagging behind. To address this gap, the web-based Parenting Resilient Kids (PaRK) program was developed to target these risk and protective factors. This study evaluated the effects of the program at 12-month follow-up.
METHODS


A randomized controlled trial was conducted with a community sample of 355 parents and 342 children (M child age  = 9.79). Parents randomized into the web-based PaRK intervention condition received a personalized feedback report about their parenting and were recommended a tailored course of up to 12 interactive modules. Parents in the control condition received a standard set of web-based educational factsheets.
RESULTS


Parents in the intervention group demonstrated significantly greater improvement in self-reported parenting compared to control group parents from baseline to 12-month follow-up, d = 0.24, 95% CI [0.03, 0.45]. Both groups showed reductions in child anxiety and depressive symptoms, parental psychological control and unhealthy family functioning; and improvements in parental acceptance, child- and parent- health-related quality of life.
LIMITATIONS


The PaRK intervention was tailored based on the parents' own report of their parenting behaviors. There was an over-representation of highly-educated mothers and only one parent-child dyad was included per family.
CONCLUSIONS


PaRK improved parenting for up to 12 months, but had no superior effect on children's mental health outcomes compared with an educational-factsheet intervention. Further follow-up is needed to assess longer-term effects.",2020,"RESULTS


Parents in the intervention group demonstrated significantly greater improvement in self-reported parenting compared to control group parents from baseline to 12-month follow-up, d ","['child anxiety and depressive disorders', 'community sample of 355 parents and 342 children (M child age \u202f=\u202f9.79']","['standard set of web-based educational factsheets', 'PaRK intervention', 'web-based PaRK intervention condition received a personalized feedback report about their parenting']","[""children's mental health outcomes"", 'child anxiety and depressive symptoms, parental psychological control and unhealthy family functioning; and improvements in parental acceptance, child- and parent- health-related quality of life', 'self-reported parenting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]",355.0,0.105364,"RESULTS


Parents in the intervention group demonstrated significantly greater improvement in self-reported parenting compared to control group parents from baseline to 12-month follow-up, d ","[{'ForeName': 'Wan Hua', 'Initials': 'WH', 'LastName': 'Sim', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Victoria, Australia.'}, {'ForeName': 'Luwishennadige Madhawee N', 'Initials': 'LMN', 'LastName': 'Fernando', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Victoria, Australia.'}, {'ForeName': 'Anthony F', 'Initials': 'AF', 'LastName': 'Jorm', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Rapee', 'Affiliation': 'Centre for Emotional Health, Macquarie University, New South Wales, Australia.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Lawrence', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Victoria, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Mackinnon', 'Affiliation': 'Black Dog Institute, University of New South Wales, New South Wales, Australia.'}, {'ForeName': 'Marie B H', 'Initials': 'MBH', 'LastName': 'Yap', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Victoria, Australia; Melbourne School of Population and Global Health, University of Melbourne, Victoria, Australia. Electronic address: marie.yap@monash.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.019']
1155,33066061,How does the Execution of the Pilates Method and Therapeutic Exercise Influence Back Pain and Postural Alignment in Children Who Play String Instruments? A Randomized Controlled Pilot Study.,"BACKGROUND


Inappropriate posture in children while playing some string instruments can cause back pain and alterations of the spine. To date, there is no research on the effect of exercise on children who play a musical instrument, although it is known that transversus abdominis muscle control through the Pilates method has shown pain reduction and posture improvement in this population.
OBJECTIVE


To assess the effectiveness of the Pilates method combined with therapeutic exercise with respect to therapeutic exercise exclusively in reducing pain and improving postural alignment in children playing string instruments applying a protocol of low dose to increase children's adherence to training.
METHODS


A randomized controlled pilot study was designed with two parallel intervention groups. Twenty-five children (10-14 years old) were randomized in two intervention groups: Pilates method with therapeutic exercise (experimental) and therapeutic exercise (control) for 4 weeks (50 min per day, one day per week). Two assessments were performed (before and after treatment) to assess back pain and shoulders and hips alignment using a visual analog scale and the Kinovea program.
RESULTS


Statistically significant differences were obtained for pain reduction before ( p  = 0.04) and after ( p  = 0.01) playing the instrument in the experimental group. There were no significant changes in alignment improvement in any of the two groups.
CONCLUSION


The application of a low dose of the Pilates method combined with therapeutic exercise could be a beneficial intervention for pain reduction before and after musical practice in children who play string instruments.",2020,Statistically significant differences were obtained for pain reduction before ( p  = 0.04) and after ( p  = 0.01) playing the instrument in the experimental group.,"['children playing string instruments', 'children who play string instruments', 'Children', 'Twenty-five children (10-14 years old']","['Pilates method with therapeutic exercise (experimental) and therapeutic exercise (control', 'Pilates method combined with therapeutic exercise']","['Back Pain and Postural Alignment', 'pain reduction', 'back pain and shoulders and hips alignment using a visual analog scale', 'pain and improving postural alignment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0443313', 'cui_str': 'Stringing'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",25.0,0.0647546,Statistically significant differences were obtained for pain reduction before ( p  = 0.04) and after ( p  = 0.01) playing the instrument in the experimental group.,"[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Poncela-Skupien', 'Affiliation': 'Integral Rehabilitation Center, CRI. 38001, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pinero-Pinto', 'Affiliation': 'Department of Physical Therapy, Faculty of Nursery, Physiotherapy and Podiatry, University of Seville, 41004 Seville, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Martínez-Cepa', 'Affiliation': 'Department of Physiotherapy, Faculty of Medicine, CEU-San Pablo University, 28003 Madrid, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Zuil-Escobar', 'Affiliation': 'Department of Physiotherapy, Faculty of Medicine, CEU-San Pablo University, 28003 Madrid, Spain.'}, {'ForeName': 'Rita Pilar', 'Initials': 'RP', 'LastName': 'Romero-Galisteo', 'Affiliation': 'Department of Physiotherapy, Faculty of Science Health, University of Málaga, 29016 Málaga, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Palomo-Carrión', 'Affiliation': 'Department of Nursery, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursery, University of Castilla-La Mancha, 45071 Toledo, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17207436']
1156,33066081,Leukocyte Activation and Antioxidative Defense Are Interrelated and Moderately Modified by n-3 Polyunsaturated Fatty Acid-Enriched Eggs Consumption-Double-Blind Controlled Randomized Clinical Study.,"This placebo-controlled, double-blind, randomized, interventional study investigated the effects of low/intermediate doses of n-3 polyunsaturated fatty acids (PUFAs) on the endothelial function, markers of leukocyte activation, and oxidative status following dietary intake of n-3 PUFA-enriched hen eggs in young healthy individuals. Twenty young healthy adults of both sexes who consumed n-3 PUFA-enriched hen eggs (two eggs per day, for three weeks, total of approximately 407 mg/day n-3 PUFAs) or regular eggs (two eggs per day for three weeks, total of approximately 75 mg/day n-3 PUFAs) participated in this study. Skin microvascular endothelium-independent and endothelium-dependent vasodilation were assessed by laser Doppler flowmetry. Serum lipid profile and content of free fatty acids, markers of leukocyte activation, biochemical parameters of oxidative stress, as well as antioxidative enzymes serum activity were measured before and after respective dietary protocol. The results of this study revealed significant differences in the markers of leukocyte activation (such as CD11a/LFA-1) and antioxidative defense, which are related to increased intake of n-3 PUFAs, providing the evidence that consumption of nutritionally enriched hen eggs may affect physiological processes related to oxidative balance. The absence of significant changes in microvascular reactivity following supplementation with a low-intermediate dose of n-3 PUFAs, unlike in our previous studies where functional eggs contained ~1 g of n-3 PUFA, suggests the existence of a dose-dependent effect.",2020,"Serum lipid profile and content of free fatty acids, markers of leukocyte activation, biochemical parameters of oxidative stress, as well as antioxidative enzymes serum activity were measured before and after respective dietary protocol.","['young healthy individuals', 'Twenty young healthy adults of both sexes who consumed n-3 PUFA-enriched hen eggs (two eggs per day, for three weeks, total of approximately 407 mg/day n-3 PUFAs) or regular eggs (two eggs per day for three weeks, total of approximately 75 mg/day n-3 PUFAs) participated in this study']","['n-3 PUFA-enriched hen eggs', 'n-3 polyunsaturated fatty acids (PUFAs', 'placebo']","['endothelial function, markers of leukocyte activation, and oxidative status', 'Skin microvascular endothelium-independent and endothelium-dependent vasodilation', 'Serum lipid profile and content of free fatty acids, markers of leukocyte activation, biochemical parameters of oxidative stress, as well as antioxidative enzymes serum activity', 'microvascular reactivity']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0440466', 'cui_str': ""Hen's egg""}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0440466', 'cui_str': ""Hen's egg""}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",20.0,0.195935,"Serum lipid profile and content of free fatty acids, markers of leukocyte activation, biochemical parameters of oxidative stress, as well as antioxidative enzymes serum activity were measured before and after respective dietary protocol.","[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mihalj', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Stupin', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Nikolina', 'Initials': 'N', 'LastName': 'Kolobarić', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Ivana Tartaro', 'Initials': 'IT', 'LastName': 'Bujak', 'Affiliation': 'Radiation Chemistry and Dosimetry Laboratory, Division of Materials Chemistry, IRB, 10000 Zagreb, Croatia.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Matić', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Zlata', 'Initials': 'Z', 'LastName': 'Kralik', 'Affiliation': 'Department of Animal Production and Biotechnology, Faculty of Agrobiotechnical Sciences, Vladimira Preloga 1, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Jukić', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Stupin', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Drenjančević', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}]",Nutrients,['10.3390/nu12103122']
1157,33066103,Transcutaneous Spinal Cord Stimulation Enhances Quadriceps Motor Evoked Potential in Healthy Participants: A Double-Blind Randomized Controlled Study.,"Transcutaneous electrical spinal cord stimulation (tSCS) is a non-invasive technique for neuromodulation and has therapeutic potential for motor rehabilitation following spinal cord injury. The main aim of the present study is to quantify the effect of a single session of tSCS on lower limb motor evoked potentials (MEPs) in healthy participants. A double-blind, sham-controlled, randomized, crossover, clinical trial was carried out in 15 participants. Two 10-min sessions of tSCS (active-tSCS and sham-tSCS) were applied at the T11-T12 vertebral level. Quadriceps (Q) and tibialis anterior (TA) muscle MEPs were recorded at baseline, during and after tSCS. Q and TA isometric maximal voluntary contraction was also recorded. A significant increase of the Q-MEP amplitude was observed during active-tSCS (1.96 ± 0.3 mV) when compared from baseline (1.40 ± 0.2 mV;  p  = 0.01) and when compared to sham-tSCS at the same time-point (1.13 ± 0.3 mV;  p  = 0.03). No significant modulation was identified for TA-MEP amplitude or for Q and TA isometric maximal voluntary isometric strength. In conclusion, tSCS applied over the T11-T12 vertebral level increased Q-MEP but not TA-MEP compared to sham stimulation. The specific neuromodulatory effect of tSCS on Q-MEP may reflect optimal excitation of this motor response at the interneuronal or motoneuronal level.",2020,No significant modulation was identified for TA-MEP amplitude or for Q and TA isometric maximal voluntary isometric strength.,"['15 participants', 'healthy participants', 'Healthy Participants']","['tSCS', 'Transcutaneous Spinal Cord Stimulation', 'tSCS (active-tSCS and sham-tSCS', 'Transcutaneous electrical spinal cord stimulation (tSCS']","['TA-MEP amplitude or for Q and TA isometric maximal voluntary isometric strength', 'Q-MEP amplitude', 'lower limb motor evoked potentials (MEPs', 'T11-T12 vertebral level increased Q-MEP', 'Q and TA isometric maximal voluntary contraction', 'Quadriceps (Q) and tibialis anterior (TA) muscle MEPs']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0054967', 'cui_str': 'Lymphocyte antigen CD6'}, {'cui': 'C0446409', 'cui_str': 'Vertebral level'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",15.0,0.247662,No significant modulation was identified for TA-MEP amplitude or for Q and TA isometric maximal voluntary isometric strength.,"[{'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Megía-García', 'Affiliation': 'Biomechanical and Technical Aids Unit, National Hospital for Paraplegia, SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Serrano-Muñoz', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing, Castilla La Mancha University, 45071 Toledo, Spain.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Sensorimotor Function Group, National Hospital for Paraplegia, SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Avendaño-Coy', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing, Castilla La Mancha University, 45071 Toledo, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Comino-Suárez', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing, Castilla La Mancha University, 45071 Toledo, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Gómez-Soriano', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing, Castilla La Mancha University, 45071 Toledo, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9103275']
1158,33066107,Effects of  Bifidobacterium animalis  Subsp.  lactis  (BPL1) Supplementation in Children and Adolescents with Prader-Willi Syndrome: A Randomized Crossover Trial.,"Prader-Willi syndrome (PWS) is a rare genetic disorder characterized by a wide range of clinical manifestations, including obesity, hyperphagia, and behavioral problems.  Bifidobacterium animalis  subsp.  lactis  strain BPL1 has been shown to improve central adiposity in adults with simple obesity. To evaluate BPL1's effects in children with PWS, we performed a randomized crossover trial among 39 patients (mean age 10.4 years). Participants were randomized to placebo-BPL1 ( n  = 19) or BPL1-placebo ( n  = 20) sequences and underwent a 12-week period with placebo/BPL1 treatments, a 12-week washout period, and a 12-week period with the crossover treatment. Thirty-five subjects completed the study. The main outcome was changes in adiposity, measured by dual-energy X-ray absorptiometry. Secondary outcomes included lipid and glucose metabolism, hyperphagia, and mental health symptoms. Generalized linear modeling was applied to assess differences between treatments. While BPL1 did not modify total fat mass compared to placebo, BPL1 decreased abdominal adiposity in a subgroup of patients older than 4.5 years ( n  = 28). BPL1 improved fasting insulin concentration and insulin sensitivity. Furthermore, we observed modest improvements in some mental health symptoms. A follow-up trial with a longer treatment period is warranted to determine whether BPL1 supplementation can provide a long-term therapeutic approach for children with PWS (ClinicalTrials.gov NCT03548480).",2020,"While BPL1 did not modify total fat mass compared to placebo, BPL1 decreased abdominal adiposity in a subgroup of patients older than 4.5 years ( n  = 28).","['Children and Adolescents with Prader-Willi Syndrome', 'children with PWS', '39 patients (mean age 10.4 years', 'adults with simple obesity', 'Thirty-five subjects completed the study']","['lactis  strain', 'BPL1-placebo', 'lactis  (BPL1) Supplementation', 'placebo/BPL1 treatments', 'placebo-BPL1', 'BPL1', 'placebo, BPL1', 'BPL1 supplementation']","['fasting insulin concentration and insulin sensitivity', 'abdominal adiposity', 'total fat mass', 'lipid and glucose metabolism, hyperphagia, and mental health symptoms', 'mental health symptoms', 'central adiposity', 'changes in adiposity, measured by dual-energy X-ray absorptiometry']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0032897', 'cui_str': 'Prader-Willi syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0451819', 'cui_str': 'Simple obesity'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0020505', 'cui_str': 'Overeating'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551560', 'cui_str': 'Central obesity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]",39.0,0.241297,"While BPL1 did not modify total fat mass compared to placebo, BPL1 decreased abdominal adiposity in a subgroup of patients older than 4.5 years ( n  = 28).","[{'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Amat-Bou', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Sonika', 'Initials': 'S', 'LastName': 'Garcia-Ribera', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Climent', 'Affiliation': 'Archer Daniels Midland Co-Biopolis, 46980 Valencia, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Piquer-Garcia', 'Affiliation': 'Department of Endocrinology and Nutrition, Germans Trias i Pujol Research Institute, 08916 Barcelona, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Corripio', 'Affiliation': ""Service of Pediatric Endocrinology, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, 08208 Sabadell, Spain.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanchez-Infantes', 'Affiliation': 'Department of Endocrinology and Nutrition, Germans Trias i Pujol Research Institute, 08916 Barcelona, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Villalta', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Elias', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Josep C', 'Initials': 'JC', 'LastName': 'Jiménez-Chillarón', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Empar', 'Initials': 'E', 'LastName': 'Chenoll', 'Affiliation': 'Archer Daniels Midland Co-Biopolis, 46980 Valencia, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ramón', 'Affiliation': 'Archer Daniels Midland Co-Biopolis, 46980 Valencia, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Ibañez', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ramon-Krauel', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Carles', 'Initials': 'C', 'LastName': 'Lerin', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}]",Nutrients,['10.3390/nu12103123']
1159,32678677,"Curcumagalactomannoside/Glucosamine Combination Improved Joint Health Among Osteoarthritic Subjects as Compared to Chondroitin Sulfate/Glucosamine: Double-Blinded, Randomized Controlled Study.","Objective:  A combination of curcumagalactomannosides (CGM) (400 mg) with glucosamine hydrochloride (GLN) (500 mg) was evaluated against a standard dietary supplement combination chondroitin sulfate (CHN) (415 mg)/GLN (500 mg) for their effectiveness in alleviating the pain and symptoms among osteoarthritic subjects.  Design:  Randomized, double-blinded and active-controlled study.  Settings/Location:  The study was conducted in a hospital-based research center in Vadodara, Gujarat, India.  Subjects:  Eighty subjects (38 males and 42 females), with confirmed osteoarthritis (OA) (Class I-III), were randomized into two parallel groups designated as Group I (CGM-GLN) and Group II (CHN-GLN).  Interventions:  All the study subjects were supplemented with their corresponding intervention capsules (ether CGM along with GLN or CHN along with GLN), as a single oral dose twice a day, once in the morning 10-15 min before breakfast and again in the evening before dinner, for 84 days.  Outcome measures:  A validated treadmill uphill walking protocol was used for the study, and the efficiency of supplementation was evaluated using visual analogue scale (VAS) score, Karnofsky Performance Scale (KPS) score, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire at the baseline, 28th, and 84th day following the treatment. Mechanism of action of CGM-GLN combination was analyzed by measuring the levels of serum inflammatory markers interleukin 1 beta (IL-1β), interleukin 6 (IL-6), and soluble vascular cell adhesion molecule-1 (sVCAM) at the baseline and 84th day.  Results:  CGM-GLN was found to offer significant beneficial effects to pain, stiffness, and physical function of OA subjects compared with CHN-GLN, which was evident from the improvement in walking performance, VAS score, KPS score, and WOMAC score. The efficiency of CGM-GLN was almost double compared with the CHN-GLN by the end of the study (84th day). A significant reduction of inflammatory serum marker levels was observed among CGM-GLN subjects compared with CHN-GLN subjects. Compared with the baseline, CGM-GLN produced 54.52%, 59.08%, and 22.03% reduction in IL-1β, IL-6, and sVCAM levels, respectively. Whereas CHN-GLN group of subjects expressed only 23.17%, 21.38%, and 6.82% reduction in IL-1β, IL-6, and sVCAM levels, respectively.  Conclusions:  In conclusion, the present study demonstrated the potential benefits of CGM-GLN supplements in alleviating the symptoms and function of OA subjects compared with the standard CHN-GLN treatment. The augmented efficacy of CGM-GLN combination could be attributed to the enhanced anti-inflammatory effect of CGM.",2020,A significant reduction of inflammatory serum marker levels was observed among CGM-GLN subjects compared with CHN-GLN subjects.,"['hospital-based research center in Vadodara, Gujarat, India', 'osteoarthritic subjects', 'Subjects:  Eighty subjects (38 males and 42 females), with confirmed osteoarthritis (OA) (Class I-III']","['glucosamine hydrochloride (GLN', 'Curcumagalactomannoside/Glucosamine', 'CHN-GLN', 'CGM-GLN', 'Chondroitin Sulfate/Glucosamine', 'standard dietary supplement combination chondroitin sulfate (CHN', 'Group I (CGM-GLN) and Group II (CHN-GLN', 'curcumagalactomannosides (CGM', 'CGM-GLN supplements', 'corresponding intervention capsules (ether CGM along with GLN or CHN along with GLN']","['efficiency of CGM-GLN', 'levels of serum inflammatory markers interleukin 1 beta (IL-1β), interleukin 6 (IL-6), and soluble vascular cell adhesion molecule-1 (sVCAM', 'efficiency of supplementation was evaluated using visual analogue scale (VAS) score, Karnofsky Performance Scale (KPS) score, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire', 'IL-1β, IL-6, and sVCAM levels', 'pain, stiffness, and physical function', 'Joint Health', 'pain and symptoms', 'inflammatory serum marker levels', 'walking performance, VAS score, KPS score, and WOMAC score']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0771903', 'cui_str': 'Glucosamine hydrochloride'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0017718', 'cui_str': 'Glucosamine'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C2929470', 'cui_str': 'Chondroitin Sulfates / Glucosamine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0014994', 'cui_str': 'ethyl ether'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0162491', 'cui_str': 'Marker, Serum'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0878425,A significant reduction of inflammatory serum marker levels was observed among CGM-GLN subjects compared with CHN-GLN subjects.,"[{'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Khanna', 'Affiliation': 'Aman Hospital and Research Center, Vadodara, India.'}, {'ForeName': 'Sivadasan Syam', 'Initials': 'SS', 'LastName': 'Das', 'Affiliation': 'R&D Centre, Akay Natural Ingredients Pvt. Ltd., Cochin, India.'}, {'ForeName': 'Thozhuthum Parambil', 'Initials': 'TP', 'LastName': 'Smina', 'Affiliation': 'R&D Centre, Akay Natural Ingredients Pvt. Ltd., Cochin, India.'}, {'ForeName': 'Jestin V', 'Initials': 'JV', 'LastName': 'Thomas', 'Affiliation': 'Leads Clinical Research & Bio Services Pvt. Ltd., Bangalore, India.'}, {'ForeName': 'Ajaikumar B', 'Initials': 'AB', 'LastName': 'Kunnumakkara', 'Affiliation': 'Department of Biosciences and Bioengineering, Indian Institute of Technology Guwahati, India.'}, {'ForeName': 'Balu', 'Initials': 'B', 'LastName': 'Maliakel', 'Affiliation': 'R&D Centre, Akay Natural Ingredients Pvt. Ltd., Cochin, India.'}, {'ForeName': 'Illathu Madhavamenon', 'Initials': 'IM', 'LastName': 'Krishnakumar', 'Affiliation': 'R&D Centre, Akay Natural Ingredients Pvt. Ltd., Cochin, India.'}, {'ForeName': 'Ratheesh', 'Initials': 'R', 'LastName': 'Mohanan', 'Affiliation': 'Department of Biochemistry, St. Thomas College, Kottayam, India.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0128']
1160,32687161,"A Phase IIa Controlled Human Malaria Infection and Immunogenicity Study of RTS,S/AS01E and RTS,S/AS01B Delayed Fractional Dose Regimens in Malaria-Naive Adults.","BACKGROUND


A previous RTS,S/AS01B vaccine challenge trial demonstrated that a 3-dose (0-1-7-month) regimen with a fractional third dose can produce high vaccine efficacy (VE) in adults challenged 3 weeks after vaccination. This study explored the VE of different delayed fractional dose regimens of adult and pediatric RTS,S/AS01 formulations.
METHODS


A total of 130 participants were randomized into 5 groups. Four groups received 3 doses of RTS,S/AS01B or RTS,S/AS01E on a 0-1-7-month schedule, with the final 1 or 2 doses being fractional (one-fifth dose volume). One group received 1 full (month 0) and 1 fractional (month 7) dose of RTS,S/AS01E. Immunized and unvaccinated control participants underwent Plasmodium falciparum-infected mosquito challenge (controlled human malaria infection) 3 months after immunization, a timing chosen to potentially discriminate VEs between groups.
RESULTS


The VE of 3-dose formulations ranged from 55% (95% confidence interval, 27%-72%) to 76% (48%-89%). Groups administered equivalent formulations of RTS,S/AS01E and RTS,S/AS01B demonstrated comparable VE. The 2-dose group demonstrated lower VE (29% [95% confidence interval, 6%-46%]). All regimens were well tolerated and immunogenic, with trends toward higher anti-circumsporozoite antibody titers in participants protected against infection.
CONCLUSIONS


RTS,S/AS01E can provide VE comparable to an equivalent RTS,S/AS01B regimen in adults, suggesting a universal formulation may be considered. Results also suggest that the 2-dose regimen is inferior to the 3-dose regimens evaluated.
CLINICAL TRIAL REGISTRATION


NCT03162614.",2020,"Groups administered equivalent formulations of RTS,S/AS01E and RTS,S/AS01B demonstrated comparable VE.","['Malaria-Naïve Adults', '130 subjects']","['RTS,S/AS01E. Immunized and unvaccinated control participants underwent Plasmodium falciparum-infected mosquito challenge (CHMI) 3M post-immunization', 'RTS,S/AS01E and RTS,S/AS01B Delayed Fractional Dose Regimens', 'RTS,S/AS01B or RTS,S/AS01E']",['lower VE'],"[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032150', 'cui_str': 'Plasmodium falciparum'}, {'cui': 'C0026584', 'cui_str': 'Family Culicidae'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",130.0,0.0363794,"Groups administered equivalent formulations of RTS,S/AS01E and RTS,S/AS01B demonstrated comparable VE.","[{'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Moon', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ockenhouse', 'Affiliation': 'PATH-Malaria Vaccine Initiative, Washington, DC, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Regules', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vekemans', 'Affiliation': 'GSK Biologicals, Rixensart, Belgium.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'PATH-Malaria Vaccine Initiative, Washington, DC, USA.'}, {'ForeName': 'Ilin', 'Initials': 'I', 'LastName': 'Chuang', 'Affiliation': 'Naval Medical Research Center, Silver Spring, Maryland, USA.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Traskine', 'Affiliation': 'GSK Biologicals, Rixensart, Belgium.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jongert', 'Affiliation': 'GSK Biologicals, Rixensart, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Ivinson', 'Affiliation': 'PATH-Malaria Vaccine Initiative, Washington, DC, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Morelle', 'Affiliation': 'GSK Biologicals, Rixensart, Belgium.'}, {'ForeName': 'Jack L', 'Initials': 'JL', 'LastName': 'Komisar', 'Affiliation': 'Naval Medical Research Center, Silver Spring, Maryland, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lievens', 'Affiliation': 'GSK Biologicals, Rixensart, Belgium.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sedegah', 'Affiliation': 'Naval Medical Research Center, Silver Spring, Maryland, USA.'}, {'ForeName': 'Lindsey S', 'Initials': 'LS', 'LastName': 'Garver', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'April K', 'Initials': 'AK', 'LastName': 'Sikaffy', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Norman C', 'Initials': 'NC', 'LastName': 'Waters', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'William Ripley', 'Initials': 'WR', 'LastName': 'Ballou', 'Affiliation': 'GSK Biologicals, Rixensart, Belgium.'}, {'ForeName': 'Opokua', 'Initials': 'O', 'LastName': 'Ofori-Anyinam', 'Affiliation': 'GSK Biologicals, Rixensart, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jiaa421']
1161,33065552,Effect of ticagrelor versus clopidogrel on platelet reactivity measured by thrombelastography in patients with minor stroke or TIA.,"In this study, we tested the effect of ticagrelor versus clopidogrel on platelet reactivity in patients with minor stroke or transient ischemic attack (TIA). A pre-specified subgroup analysis of a randomized controlled trial was conducted. Platelet reactivity was assessed by thrombelastography (TEG) platelet mapping. Patients were divided into carriers and non-carriers according to the carrier status of  CYP2C19  loss-of-function (LOF) alleles. The primary outcome was the proportion of patients with high on-treatment platelet reactivity (HOPR) (defined as maximum amplitude induced by adenosine diphosphate > 47mm) at 90±7 days. Clinical outcomes within 90±7 days were followed up. Among 339 patients, 170 were randomized to ticagrelor/aspirin and 169 to clopidogrel/aspirin. Compared with clopidogrel/aspirin, the proportion of HOPR at 90±7 days in ticagrelor/aspirin was significantly lower (12.2% versus 30.0%,  P  < 0.001). Ticagrelor/aspirin had a lower proportion of HOPR among carriers (11.0% versus 35.6%,  P  < 0.001), but not among non-carriers (13.5% versus 22.4%,  P  = 0.17). Ticagrelor was superior to clopidogrel in inhibiting platelet reactivity measured by TEG platelet mapping among patients with acute minor stroke or TIA, particularly in carriers of the  CYP2C19  LOF alleles. Large randomised controlled trials are needed to confirm our findings.",2020,"Ticagrelor was superior to clopidogrel in inhibiting platelet reactivity measured by TEG platelet mapping among patients with acute minor stroke or TIA, particularly in carriers of the  CYP2C19  LOF alleles.","['patients with minor stroke or TIA', 'patients with minor stroke or transient ischemic attack (TIA', 'Patients were divided into carriers and non-carriers according to the carrier status of  CYP2C19  loss-of-function (LOF) alleles', '339 patients, 170 were randomized to']","['Ticagrelor', 'clopidogrel/aspirin', 'Ticagrelor/aspirin', 'ticagrelor/aspirin', 'clopidogrel', 'ticagrelor versus clopidogrel', 'ticagrelor']","['HOPR', 'proportion of patients with high on-treatment platelet reactivity (HOPR', 'Platelet reactivity', 'proportion of HOPR', 'platelet reactivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0449439', 'cui_str': 'Carrier status'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C4517599', 'cui_str': '170'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",339.0,0.0541763,"Ticagrelor was superior to clopidogrel in inhibiting platelet reactivity measured by TEG platelet mapping among patients with acute minor stroke or TIA, particularly in carriers of the  CYP2C19  LOF alleles.","[{'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Weiqi', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuesong', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hongyi', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}]",Aging,['10.18632/aging.103452']
1162,33065589,Randomized Trial of 2 Delayed-Release Formulations of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation.,"INTRODUCTION


Immediate-release (IR) formulation of linaclotide 290 μg improves abdominal pain and constipation (APC) in patients with irritable bowel syndrome (IBS) with constipation. Delayed-release (DR) formulations were developed on the premise that targeting the ileum (delayed-release formulation 1 [DR1]) or ileocecal junction and cecum (MD-7246, formerly DR2) would modulate linaclotide's secretory effects while preserving pain relief effects.
METHODS


This phase 2b study randomized patients with IBS with constipation to placebo or 1 of 7 once-daily linaclotide doses (DR1 30, 100, or 300 μg; MD-7246 30, 100, or 300 μg; or IR 290 μg) for 12 weeks. Key efficacy endpoints were change from baseline in abdominal pain and complete spontaneous bowel movement frequency, and 6/12-week combined APC+1 responder rate.
RESULTS


Overall, 532 patients were randomized; mean age was 45.1 years, and most were women (83.3%) and White (64.7%). All linaclotide DR1 and MD-7246 groups experienced greater improvements in abdominal pain from baseline and vs placebo throughout treatment. Linaclotide DR1 and IR led to numerically greater improvements from baseline in complete spontaneous bowel movement frequency and higher APC+1 responder rates compared with placebo; MD-7246 results were similar to placebo. Diarrhea was the most common adverse event with DR1 and IR; rates were similar between MD-7246 and placebo.
DISCUSSION


Altering the site of drug delivery in the intestine might uncouple linaclotide's pain relief from secretory effects. Persistent, modest abdominal pain improvement with limited impact on bowel symptom parameters, as seen across MD-7246 doses, warrants further study of MD-7246 as a novel treatment for abdominal pain, regardless of IBS subtype.",2020,All linaclotide DR1 and MD-7246 groups experienced greater improvements in abdominal pain from baseline and vs placebo throughout treatment.,"['patients with IBS with constipation to', '532 patients were randomized; mean age was 45.1 years, and most were women (83.3%) and White (64.7', 'Patients With Irritable Bowel Syndrome With Constipation', 'patients with irritable bowel syndrome (IBS) with constipation']","['placebo', 'placebo or 1 of 7 once-daily linaclotide', '2 Delayed-Release Formulations of Linaclotide', 'linaclotide 290 μg']","['Delayed-release (DR) formulations', 'Diarrhea', 'abdominal pain and complete spontaneous bowel movement frequency, and 6/12-week combined APC+1 responder rate', 'abdominal pain', 'abdominal pain and constipation (APC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C2000261', 'cui_str': 'linaclotide'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C5191218', 'cui_str': '290'}]","[{'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0426642', 'cui_str': 'Frequency of bowel action'}, {'cui': 'C0442752', 'cui_str': 'Distance vision 6/12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0003315', 'cui_str': 'Immunologic Accessory Cells'}]",532.0,0.32261,All linaclotide DR1 and MD-7246 groups experienced greater improvements in abdominal pain from baseline and vs placebo throughout treatment.,"[{'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Chey', 'Affiliation': 'Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Sayuk', 'Affiliation': 'Division of Gastroenterology, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Wilmin', 'Initials': 'W', 'LastName': 'Bartolini', 'Affiliation': 'Ironwood Pharmaceuticals, Inc., Boston, Massachusetts, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Reasner', 'Affiliation': 'Imbria Pharmaceuticals, Boston, Massachusetts, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Fox', 'Affiliation': 'AbbVie, Inc., Madison, New Jersey, USA.'}, {'ForeName': 'Wieslaw', 'Initials': 'W', 'LastName': 'Bochenek', 'Affiliation': 'AbbVie, Inc., Madison, New Jersey, USA.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Boinpally', 'Affiliation': 'AbbVie, Inc., Madison, New Jersey, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Shea', 'Affiliation': 'Ironwood Pharmaceuticals, Inc., Boston, Massachusetts, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Tripp', 'Affiliation': 'Cyclerion Therapeutics, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Borgstein', 'Affiliation': 'Ironwood Pharmaceuticals, Inc., Boston, Massachusetts, USA.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000967']
1163,33065642,Cost-Effectiveness of Restrictive Strategy Versus Usual Care for Cholecystectomy in Patients With Gallstones and Abdominal Pain (SECURE-Trial).,"OBJECTIVE


To perform a cost-effectiveness analysis (CEA) of restrictive strategy versus usual care in patients with gallstones and abdominal pain.
SUMMARY BACKGROUND DATA


A restrictive selection strategy for surgery in patients with gallstones reduces cholecystectomies, but the impact on overall costs and cost-effectiveness is unknown.
METHODS


Data of a multicentre, randomized-controlled trial (SECURE-trial) were used. Adult patients with gallstones and abdominal pain were included. Restrictive strategy was economically evaluated against usual care from a societal perspective. Hospital-use of resources was gathered with case-report forms and out-of-hospital consultations, out-of-pocket expenses, and productivity loss were collected with questionnaires. National unit costing was applied. The primary outcome was the cost per pain-free patient after 12 months.
RESULTS


All 1067 randomized patients (49.0 years, 73.7% females) were included. After 12 months, 56.2% of patients was pain-free in restrictive strategy versus 59.8% after usual care. The restrictive strategy significantly reduced the cholecystectomy rate with 7.7% and reduced surgical costs with &OV0556;160 per patient, &OV0556;162 was saved from a societal perspective. The cost-effectiveness plane showed that restrictive strategy was cost saving in 89.1%, but resulted in less pain-free patients in 88.5%. Overall, the restrictive strategy saved &OV0556;4563 from a societal perspective per pain-free patient lost.
CONCLUSIONS


A restrictive selection strategy for cholecystectomy saves &OV0556;162 compared to usual care, but results in fewer pain-free patients. The incremental cost per pain-free patient are savings of &OV0556;4563 per pain-free patient lost. The higher societal willingness to pay for one extra pain-free patient, the lower the probability that the restrictive strategy will be cost-effective.
TRIAL REGISTRATION


The Netherlands National Trial Register NTR4022. Registered on 5 June 2013.",2020,"The restrictive strategy significantly reduced the cholecystectomy rate with 7.7% and reduced surgical costs with &OV0556;160 per patient, &OV0556;162 was saved from a societal perspective.","['patients with gallstones reduces cholecystectomies', 'Adult patients with gallstones and abdominal pain were included', 'All 1067 randomized patients (49.0 years, 73.7% females) were included', 'Patients With Gallstones and Abdominal Pain (SECURE-Trial', 'patients with gallstones and abdominal pain']","['Restrictive Strategy Versus Usual Care for Cholecystectomy', 'restrictive strategy versus usual care']","['pain-free in restrictive strategy', 'cost-effectiveness plane', 'cost per pain-free patient after 12 months', 'surgical costs', 'cholecystectomy rate', 'overall costs and cost-effectiveness', 'cost saving']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}]","[{'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}]",1067.0,0.122366,"The restrictive strategy significantly reduced the cholecystectomy rate with 7.7% and reduced surgical costs with &OV0556;160 per patient, &OV0556;162 was saved from a societal perspective.","[{'ForeName': 'Carmen S S', 'Initials': 'CSS', 'LastName': 'Latenstein', 'Affiliation': 'Departments of Surgery.'}, {'ForeName': 'Sarah Z', 'Initials': 'SZ', 'LastName': 'Wennmacker', 'Affiliation': 'Departments of Surgery.'}, {'ForeName': 'Aafke H', 'Initials': 'AH', 'LastName': 'van Dijk', 'Affiliation': 'Departments of Surgery and.'}, {'ForeName': 'Joost P H', 'Initials': 'JPH', 'LastName': 'Drenth', 'Affiliation': 'Departments of Gastroenterology and Hepatology and.'}, {'ForeName': 'Gert P', 'Initials': 'GP', 'LastName': 'Westert', 'Affiliation': 'IQ healthcare, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Cornelis J H M', 'Initials': 'CJHM', 'LastName': 'van Laarhoven', 'Affiliation': 'Departments of Surgery.'}, {'ForeName': 'Marja A', 'Initials': 'MA', 'LastName': 'Boermeester', 'Affiliation': 'Departments of Surgery and.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'de Reuver', 'Affiliation': 'Departments of Surgery.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Epidemiology and Data Science, Amsterdam UMC - location AMC, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004532']
1164,33065643,Multicenter Randomized Phase 2 Trial Comparing Chemoradiotherapy and Docetaxel Plus 5-Fluorouracil and Cisplatin (DCF) Chemotherapy as Initial Induction Therapy for Subsequent Conversion Surgery in Patients with Clinical T4b Esophageal Cancer: Short-term Results.,"OBJECTIVE


We conducted a multicenter randomized prospective phase 2 trial of chemoradiotherapy (CRT) versus chemotherapy (CT) as initial induction therapy for conversion surgery (CS) in clinical T4b esophageal cancer. We compared treatment effects and adverse events.
SUMMARY BACKGROUND DATA


Although induction followed by CS is potentially curative for T4b esophageal cancer, the optimal initial induction treatment is unclear.
METHODS


Ninety-nine patients with T4b esophageal cancer were randomly allocated to chemoradiotherapy (Group A, n = 49) or CT (Group B, n = 50) as initial induction treatment. CRT consisted of radiation (50.4 Gy) with cisplatin and 5-fluorouracil. CT consisted of 2 cycles of docetaxel plus cisplatin and 5-fluorouracil (DCF). CRT or CT was followed by CS if resectable. If unresectable, the patient received the other treatment as secondary treatment. CS was performed if resectable after secondary treatment. The primary end point was 2-year overall survival.
RESULTS


In Group A, CS was performed in 34 (69%) and 7 patients (14%) after initial and secondary treatment. In Group B, CS was performed in 25 (50%) and 17 patients (34%) after initial and secondary treatment. The R0 resection rate after initial and secondary treatment was similar (78% vs 76%, P = 1.000). Adverse events including leukopenia, neutropenia, febrile neutropenia, and diarrhea were significantly more frequent in Group B. Group A had better histological complete response of the primary tumor (40% vs 17%, P = 0.028) and histological nodal status (P = 0.038).
CONCLUSIONS


Upfront CRT was superior to upfront CT in terms of pathological effects and adverse events. The Japan Registry of Clinical Trials (s051180164).",2020,"Adverse events including leukopenia, neutropenia, febrile neutropenia, and diarrhea were significantly more frequent in Group B. Group A had better histological complete response of the primary tumor (40% vs 17%, P = 0.028) and histological nodal status (P = 0.038).
","['Patients with Clinical T4b Esophageal Cancer', 'clinical T4b esophageal cancer', 'Ninety-nine patients with T4b esophageal cancer', 'T4b esophageal cancer']","['CRT or CT', 'chemoradiotherapy', 'chemoradiotherapy (CRT) versus chemotherapy (CT', 'CT', 'cisplatin and 5-fluorouracil', 'Chemoradiotherapy and Docetaxel Plus 5-Fluorouracil and Cisplatin (DCF) Chemotherapy', 'CS', 'docetaxel plus cisplatin and 5-fluorouracil (DCF']","['histological nodal status', 'histological complete response', 'R0 resection rate', 'leukopenia, neutropenia, febrile neutropenia, and diarrhea', '2-year overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0475396', 'cui_str': 'Tumor stage T4b'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C3828813', 'cui_str': '99'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",99.0,0.0874203,"Adverse events including leukopenia, neutropenia, febrile neutropenia, and diarrhea were significantly more frequent in Group B. Group A had better histological complete response of the primary tumor (40% vs 17%, P = 0.028) and histological nodal status (P = 0.038).
","[{'ForeName': 'Keijiro', 'Initials': 'K', 'LastName': 'Sugimura', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Miyata', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Departments of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Makino', 'Affiliation': 'Departments of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takeno', 'Affiliation': 'Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Surgery, Kindai University Faculty of Medicine, Osaka Sayama, Osaka, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Motoori', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Yamasaki', 'Affiliation': 'Departments of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kimura', 'Affiliation': 'Department of Surgery, Kindai University Faculty of Medicine, Osaka Sayama, Osaka, Japan.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Hirao', 'Affiliation': 'Department of Surgery, National Hospital Organization, Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Fujitani', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Takusi', 'Initials': 'T', 'LastName': 'Yasuda', 'Affiliation': 'Department of Surgery, Kindai University Faculty of Medicine, Osaka Sayama, Osaka, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyusyu University, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Eguchi', 'Affiliation': 'Departments of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Yano', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Doki', 'Affiliation': 'Departments of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.'}]",Annals of surgery,['10.1097/SLA.0000000000004564']
1165,33065650,"Comment on ""ALPPS Improves Survival Compared with TSH in Patients Affected of CRLM. Survival Analysis from the Randomized Controlled Trial LIGRO"" by K. Hasselgren, et al., Annals of Surgery 2020 The Jury is Still Out.",,2020,,['Surgery 2020'],[],['Survival'],"[{'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.144463,,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bomze', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel Ella Lemelbaum Institute for Immuno-oncology, Sheba Medical Center, Ramat-Gan 526260, Israel Department of Clinical Microbiology and Immunology, Sackler Faculty of Medicine, Tel Aviv University, Tel-Aviv, Israel Ella Lemelbaum Institute for Immuno-oncology, Sheba Medical Center, Ramat-Gan 526260, Israel The Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel Department of Hepatobiliary and Pancreatic Surgery and Transplantation, Sheba Medical Center, Faculty of Medicine Tel Aviv University, Tel Aviv, Israel Centre Hépato-Biliaire, Department of Hepatobiliary and Pancreatic Surgery and Transplantation, Paul Brousse Hospital, Assistance Publique-Hôpitaux de Paris, Université Paris-Sud, Villejuif, France.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Markel', 'Affiliation': ''}, {'ForeName': 'Tomer', 'Initials': 'T', 'LastName': 'Meirson', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Azoulay', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004537']
1166,33065840,Strategies for augmentation of high-frequency left-sided repetitive transcranial magnetic stimulation treatment of major depressive disorder.,"BACKGROUND


Repetitive Transcranial Magnetic Stimulation (rTMS) is an effective intervention for treatment-resistant Major Depressive Disorder (MDD). Early improvement during high-frequency left-sided (HFL) stimulation of the dorsolateral prefrontal cortex (DLPFC) is an important predictor of longer-term outcome, but most patients benefit later in their treatment course. We examined patients without early improvement with HFL to determine whether augmentation with additional stimulation approaches improved treatment outcome.
METHODS


139 participants received HFL in a measurement-based care paradigm. Participants who achieved < 20% improvement by treatment 10 could continue with HFL (N = 17) or receive one of two augmentation strategies: bilateral stimulation (BL; HFL followed by low-frequency stimulation of right DLPFC) (N = 69) or intermittent theta-burst priming of left DLPFC (iTBS-P) (N = 17) for their remaining treatment sessions. The primary outcome was the percent reduction in depressive symptoms at treatment 30.
RESULTS


Participants who achieved < 20% improvement by treatment 10 and continued with HFL showed limited benefit. iTBS-P participants had significantly greater improvement, while those receiving BL trended toward improved outcomes. Ten sessions of either augmentation strategy appeared necessary to determine the likelihood of benefit.
CONCLUSIONS


Augmentation of early non-response to HFL appears to improve rTMS outcomes, with a novel iTBS-P strategy surpassing both continued HFL or BL treatment in participants with < 20% improvement after 10 treatments. These findings suggest that measurement-based care with addition of augmented stimulation for those not showing early improvement may yield superior rTMS treatment outcomes.",2020,"iTBS-P participants had significantly greater improvement, while those receiving BL trended toward improved outcomes.","['major depressive disorder', '139 participants received', 'Participants who achieved < 20% improvement by treatment 10 could continue with HFL (N\xa0=\xa017) or receive one of two']","['repetitive transcranial magnetic stimulation treatment', 'intermittent theta-burst priming of left DLPFC (iTBS-P', 'augmentation strategies: bilateral stimulation (BL; HFL followed by low-frequency stimulation of right DLPFC', 'Repetitive Transcranial Magnetic Stimulation (rTMS', 'HFL in a measurement-based care paradigm']","['rTMS outcomes', 'depressive symptoms']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0205091', 'cui_str': 'Left'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",139.0,0.0501479,"iTBS-P participants had significantly greater improvement, while those receiving BL trended toward improved outcomes.","[{'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Lee', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.. Electronic address: JonathanCLee@mednet.ucla.edu.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Wilson', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Corlier', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Tadayonnejad', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.; California Institute of Technology, Division of the Humanities and Social Sciences, 1200 E California Blvd, Pasadena, CA, 91125, United States.'}, {'ForeName': 'Katharine G', 'Initials': 'KG', 'LastName': 'Marder', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Pleman', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Krantz', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Wilke', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Levitt', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.'}, {'ForeName': 'Nathaniel D', 'Initials': 'ND', 'LastName': 'Ginder', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.; VA Greater Los Angeles Healthcare System, 11301 Wilshire Blvd, Los Angeles, CA 90073, United States.'}, {'ForeName': 'Andrew F', 'Initials': 'AF', 'LastName': 'Leuchter', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.011']
1167,33065952,"Comparing Injectable DaxibotulinumtoxinA and OnabotulinumtoxinA in Moderate and Severe Glabellar Lines: Additional Analyses From a Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Study.","BACKGROUND


Injectable daxibotulinumtoxinA (RT002) is an investigational botulinum toxin Type A. Published Phase 2 data show that, compared with 20U onabotulinumtoxinA, 40U daxibotulinumtoxinA is associated with a significantly greater response rate and significantly longer duration of response (median 24 weeks), and appears generally safe and well tolerated (www.clinicaltrials.gov NCT02303002).
OBJECTIVE


To evaluate whether these efficacy and safety findings are influenced by baseline glabellar line severity.
MATERIALS AND METHODS


In the Phase 2, randomized, dose-ranging, parallel-group, double-blind, multicenter study, subjects with moderate or severe glabellar lines at maximum frown were randomly assigned to 20U, 40U, or 60U daxibotulinumtoxinA, 20U onabotulinumtoxinA, or placebo. Efficacy was evaluated by investigators for ≥24 weeks.
RESULTS


Data from the per protocol population (n = 191) stratified by baseline glabellar line severity (125 moderate, 66 severe) suggest that the clinical advantage of 40U daxibotulinumtoxinA over 20U onabotulinumtoxinA is maintained for a range of efficacy outcomes regardless of whether glabellar lines are moderate or severe at baseline. Statistical evaluations were not completed due to the limited size of each subgroup.
CONCLUSION


40U daxibotulinumtoxinA appears to offer a clinical efficacy advantage over 20U onabotulinumtoxinA in both moderate and severe glabellar lines-with a greater advantage observed in severe glabellar lines.",2017,40U daxibotulinumtoxinA appears to offer a clinical efficacy advantage over 20U onabotulinumtoxinA in both moderate and severe glabellar lines-with a greater advantage observed in severe glabellar lines.,"['Data from the per protocol population (n = 191) stratified by baseline glabellar line severity (125 moderate, 66 severe', 'Moderate and Severe Glabellar Lines', 'subjects with moderate or severe glabellar lines at maximum frown']","['Injectable DaxibotulinumtoxinA and OnabotulinumtoxinA', 'daxibotulinumtoxinA (RT002', 'daxibotulinumtoxinA, 20U onabotulinumtoxinA, or placebo']","['Efficacy', 'safe and well tolerated']","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0442019', 'cui_str': 'Glabellar'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",191.0,0.432342,40U daxibotulinumtoxinA appears to offer a clinical efficacy advantage over 20U onabotulinumtoxinA in both moderate and severe glabellar lines-with a greater advantage observed in severe glabellar lines.,"[{'ForeName': 'Vince', 'Initials': 'V', 'LastName': 'Bertucci', 'Affiliation': '*Division of Dermatology, University of Toronto, Toronto, Ontario, Canada; Departments of †Dermatology and Skin Science, and ‡Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada; §Faculty of Medicine, McMaster University, Hamilton, Ontario, Canada; ‖Dermetics, Burlington, Ontario, Canada; ¶The Westmount Institute of Plastic Surgery, Montreal, Québec, Canada; #Clinical Development Department, Revance Therapeutics, Inc., Newark, California; **Write on Target Ltd., Leighton Buzzard, United Kingdom.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Humphrey', 'Affiliation': ''}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Carruthers', 'Affiliation': ''}, {'ForeName': 'Nowell', 'Initials': 'N', 'LastName': 'Solish', 'Affiliation': ''}, {'ForeName': 'Channy', 'Initials': 'C', 'LastName': 'Muhn', 'Affiliation': ''}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Swift', 'Affiliation': ''}, {'ForeName': 'Roman G', 'Initials': 'RG', 'LastName': 'Rubio', 'Affiliation': ''}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Shears', 'Affiliation': ''}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Rosen', 'Affiliation': ''}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000001364']
1168,33065953,Forehead Line Treatment With OnabotulinumtoxinA in Subjects With Forehead and Glabellar Facial Rhytids: A Phase 3 Study.,"BACKGROUND


Effacement of horizontal forehead lines (FHL) with onabotulinumtoxinA has not been investigated in prospective Phase 3 studies.
OBJECTIVE


To evaluate safety and efficacy of onabotulinumtoxinA treatment of FHL together with glabellar lines (GL).
MATERIALS AND METHODS


A 12-month, Phase 3 study randomized subjects with moderate-to-severe FHL and GL to onabotulinumtoxinA 40 U or placebo, distributed between the frontalis (20 U) and glabellar complex (20 U). After Day 180, subjects could receive up to 2 additional open-label onabotulinumtoxinA treatments. Efficacy was assessed using the Facial Wrinkle Scale (FWS) and Facial Line Outcomes questionnaire.
RESULTS


The intent-to-treat (ITT) population included 391 subjects, and the modified ITT (mITT) population (subjects with psychological impact) included 254 subjects. After 30 days, onabotulinumtoxinA significantly improved the investigator- and subject-assessed appearance of FHL severity by at least 2 FWS grades in 61.4% of ITT subjects versus 0% of placebo subjects (p < .0001). In the mITT population, 94.8% of onabotulinumtoxinA subjects and 1.7% of placebo subjects achieved investigator- and subject-assessed FWS ratings of none/mild (p = .0003). Patient-reported outcomes were consistent with FWS ratings. OnabotulinumtoxinA was well tolerated.
CONCLUSION


OnabotulinumtoxinA 40 U distributed between the frontalis and glabellar complex was safe and effective for treatment of moderate-to-severe FHL.",2017,"After 30 days, onabotulinumtoxinA significantly improved the investigator- and subject-assessed appearance of FHL severity by at least 2 FWS grades in 61.4% of ITT subjects versus 0% of placebo subjects (p < .0001).","['A 12-month, Phase 3 study randomized subjects with moderate-to-severe FHL and GL to onabotulinumtoxinA 40 U or placebo, distributed between the frontalis (20 U) and glabellar complex (20 U', '391 subjects, and the modified ITT (mITT) population (subjects with psychological impact) included 254 subjects', 'Subjects With Forehead and Glabellar Facial Rhytids']","['onabotulinumtoxinA', 'placebo', 'FHL together with glabellar lines (GL', 'Forehead Line Treatment With OnabotulinumtoxinA', 'OnabotulinumtoxinA', 'horizontal forehead lines (FHL) with onabotulinumtoxinA']","['Facial Wrinkle Scale (FWS) and Facial Line Outcomes questionnaire', 'Efficacy', 'investigator- and subject-assessed FWS ratings', 'investigator- and subject-assessed appearance of FHL severity']","[{'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0442019', 'cui_str': 'Glabellar'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0442019', 'cui_str': 'Glabellar'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",391.0,0.0339966,"After 30 days, onabotulinumtoxinA significantly improved the investigator- and subject-assessed appearance of FHL severity by at least 2 FWS grades in 61.4% of ITT subjects versus 0% of placebo subjects (p < .0001).","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fagien', 'Affiliation': '*Aesthetic Eyelid Plastic Surgery, Boca Raton, Florida; †AboutSkin Dermatology and DermSurgery, Greenwood Village, Colorado; ‡Coleman Center for Cosmetic Dermatologic Surgery, Metairie, Louisiana; §Total Skin and Beauty Dermatology Center, Birmingham, Alabama; ‖Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada; ¶Peloton Advantage, Parsippany, New Jersey; #Allergan plc, Irvine, California.'}, {'ForeName': 'Joel L', 'Initials': 'JL', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Coleman', 'Affiliation': ''}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Monheit', 'Affiliation': ''}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Carruthers', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Street', 'Affiliation': ''}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'Larsen', 'Affiliation': ''}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Yushmanova', 'Affiliation': ''}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': ''}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Vitarella', 'Affiliation': ''}, {'ForeName': 'Cheri', 'Initials': 'C', 'LastName': 'Mao', 'Affiliation': ''}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000001414']
1169,33065954,IncobotulinumtoxinA Is an Effective and Well-Tolerated Treatment for Upper Facial Lines: Results From an Open-Label Extension Period of a Phase III Study.,"BACKGROUND


In clinical practice, different upper facial areas are commonly treated together.
OBJECTIVE


To evaluate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper facial lines (UFL) in a 3-month open-label extension (OLEX) period.
MATERIALS AND METHODS


In the main study period (randomized, double blind, placebo controlled; n = 156), subjects with moderate-to-severe UFL (glabellar frown lines [GFL], horizontal forehead lines [HFL], and lateral periorbital lines [LPL]) on the 5-point Merz Aesthetics Scales (MAS) received 54 to 64 U incobotulinumtoxinA or placebo. In the OLEX, all subjects (n = 139) received 1 treatment with 54 to 64 U incobotulinumtoxinA. Investigator- and subject-assessed MAS scores were evaluated at rest and maximum contraction. Response was defined either as a MAS score of ""none"" or ""mild"" or a ≥1-point improvement in MAS scores.
RESULTS


A clear, rapid treatment response was seen in each individual treated area and for all areas combined. At Day 30, a response of none or mild at maximum contraction (investigator's rating) was reported for 80.1%, 77.2%, and 66.9% of subjects for GFL, HFL, and LPL, respectively. IncobotulinumtoxinA was well tolerated, with no evidence of an increase in adverse events with repeat injection.
CONCLUSION


IncobotulinumtoxinA is highly effective for the simultaneous treatment of UFL with a good safety profile (EudraCT Number: 2011-005887-20).",2017,"IncobotulinumtoxinA was well tolerated, with no evidence of an increase in adverse events with repeat injection.
","['subjects with moderate-to-severe UFL (glabellar frown lines [GFL], horizontal forehead lines [HFL], and lateral periorbital lines [LPL]) on the 5-point Merz Aesthetics Scales (MAS) received 54 to 64 U', 'Upper Facial Lines']","['incobotulinumtoxinA injections', 'placebo', 'IncobotulinumtoxinA', 'incobotulinumtoxinA or placebo']","['efficacy and safety', 'adverse events', ""response of none or mild at maximum contraction (investigator's rating"", 'MAS scores']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0948887', 'cui_str': 'Glabellar frown lines'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0230064', 'cui_str': 'Periorbital'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0961667,"IncobotulinumtoxinA was well tolerated, with no evidence of an increase in adverse events with repeat injection.
","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Trevidic', 'Affiliation': '*Expert2Expert, Paris, France; †Regency Medical Clinic, Glasgow, United Kingdom; ‡Private Practice for Skin Diseases, Allergology and Aesthetic Dermatology, Ludwigshafen, Germany; §Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany; ‖Ogilvy Healthworld, Oxford, United Kingdom; ¶Clinique Esthétique St George, Nice, France; #Department for Plastic, Reconstructive and Aesthetic Surgery, Red Cross Hospital, Kassel, Germany; **Rosenparkklinik, Darmstadt, Germany; and ††Division of Cosmetic Science, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Simon A', 'Initials': 'SA', 'LastName': 'Connolly', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Biwer', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ellers-Lenz', 'Affiliation': ''}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Harrington', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Kestemont', 'Affiliation': ''}, {'ForeName': 'Ernst M', 'Initials': 'EM', 'LastName': 'Noah', 'Affiliation': ''}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Sattler', 'Affiliation': ''}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Weissenberger', 'Affiliation': ''}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kerscher', 'Affiliation': ''}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000001416']
1170,33066338,"Effect of a Short-Time Probiotic Supplementation on the Abundance of the Main Constituents of the Gut Microbiota of Term Newborns Delivered by Cesarean Section-A Randomized, Prospective, Controlled Clinical Trial.","The gut microbiota plays a pivotal role in the maintenance of human health. Numerous factors, including the mode of delivery, impact early gut colonization in newborns. Recent research focuses on the use of probiotics in the prevention of gut dysbiosis in newborns delivered by cesarean section (CS). The objective of this study was to determine whether a probiotic supplement given to newborns delivered by CS during their stay in the maternity ward alters the pattern of early gut colonization by lactic acid bacteria versus potential pathogens. A prospective, randomized trial was conducted. In total, 150 newborns, born at 38-40 weeks gestational age and delivered by CS, were included in the study. They were randomized into the intervention group, supplemented orally with a probiotic containing  Bifidobacterium breve  PB04 and  Lactobacillus rhamnosus  KL53A, and the control group. Stool samples were obtained on days 5 and 6 of life and after one month of life and were analyzed for the presence and abundance of the main groups of bacteria. An application of two probiotic bacteria during the first days of life after CS resulted in quick and abundant colonization by days 5 and 6, with high populations of  L. rhamnosus  and  B. breve . The applied bacterial strains were present in the majority of neonates one month after. The supplementation of term neonates delivered by cesarean section immediately after birth with a mixture of  L. rhamnosus  and  B. breve  enriched the gut microbiota composition with lactic acid bacteria.",2020,Recent research focuses on the use of probiotics in the prevention of gut dysbiosis in newborns delivered by cesarean section (CS).,"['In total, 150 newborns, born at 38-40 weeks gestational age and delivered by CS, were included in the study', 'newborns delivered by cesarean section (CS', 'newborns']","['probiotic supplement', 'Short-Time Probiotic Supplementation', 'cesarean section immediately after birth with a mixture of', 'probiotic containing  Bifidobacterium breve  PB04 and  Lactobacillus rhamnosus  KL53A, and the control group', 'L. rhamnosus  and  B']",['quick and abundant colonization'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}]",150.0,0.035509,Recent research focuses on the use of probiotics in the prevention of gut dysbiosis in newborns delivered by cesarean section (CS).,"[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Hurkala', 'Affiliation': 'Neonatology Clinic, University Hospital, Medical College, Jagiellonian University, Kopernika 23 Str, 31-501 Kraków, Poland.'}, {'ForeName': 'Ryszard', 'Initials': 'R', 'LastName': 'Lauterbach', 'Affiliation': 'Neonatology Clinic, University Hospital, Medical College, Jagiellonian University, Kopernika 23 Str, 31-501 Kraków, Poland.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Radziszewska', 'Affiliation': 'Neonatology Clinic, University Hospital, Medical College, Jagiellonian University, Kopernika 23 Str, 31-501 Kraków, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Strus', 'Affiliation': 'Chair of Microbiology, Medical College, Jagiellonian University, Kraków, Czysta 18 Str, 31-121 Kraków, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Heczko', 'Affiliation': 'Chair of Microbiology, Medical College, Jagiellonian University, Kraków, Czysta 18 Str, 31-121 Kraków, Poland.'}]",Nutrients,['10.3390/nu12103128']
1171,33066348,An Acute Application of Cerebellar Transcranial Direct Current Stimulation Does Not Improve Motor Performance in Parkinson's Disease.,"Transcranial direct current stimulation of the cerebellum (c-tDCS) improves motor performance in young and old adults. Based on the cerebellar involvement in Parkinson's disease (PD), c-tDCS could have potential to improve motor function in PD. The purpose was to determine the effects of c-tDCS on motor performance in PD while participants were on medications. The study was a randomized, double-blind, SHAM-controlled, between-subjects design. Twenty-two participants with PD were allocated to either a c-tDCS group or a SHAM group. All participants completed one experimental session and performed two motor tasks with their most affected hand in a Baseline condition (no stimulation) and an Experimental condition. The motor tasks were a visuomotor isometric precision grip task (PGT) and a rapid arm movement task (AMT). The primary dependent variables were force error and endpoint error in the PGT and AMT, respectively. There were no significant differences in force error or endpoint error in the Experimental condition between the c-tDCS and SHAM groups. These results indicate that an acute application of c-tDCS does not enhance motor performance in hand and arm tasks in PD. Longer-term c-tDCS application over multiple days may be needed to enhance motor function in PD.",2020,There were no significant differences in force error or endpoint error in the Experimental condition between the c-tDCS and SHAM groups.,"[""Parkinson's Disease"", 'Twenty-two participants with PD', 'young and old adults']","['SHAM', 'Transcranial direct current stimulation of the cerebellum (c-tDCS', 'c-tDCS', 'Cerebellar Transcranial Direct Current Stimulation']","['Motor Performance', 'visuomotor isometric precision grip task (PGT) and a rapid arm movement task (AMT', 'force error and endpoint error', 'motor performance']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",22.0,0.189365,There were no significant differences in force error or endpoint error in the Experimental condition between the c-tDCS and SHAM groups.,"[{'ForeName': 'Lidio', 'Initials': 'L', 'LastName': 'Lima de Albuquerque', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Pantovic', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Mitchel', 'Initials': 'M', 'LastName': 'Clingo', 'Affiliation': 'School of Medicine, University of Nevada Las Vegas, Las Vegas, NV 89102, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Jalene', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Merrill', 'Initials': 'M', 'LastName': 'Landers', 'Affiliation': 'Department of Physical Therapy, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Zoltan', 'Initials': 'Z', 'LastName': 'Mari', 'Affiliation': 'Movement Disorders Program, Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV 89106, USA.'}, {'ForeName': 'Brach', 'Initials': 'B', 'LastName': 'Poston', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}]",Brain sciences,['10.3390/brainsci10100735']
1172,33066469,Chemically Activated Cooling Vest's Effect on Cooling Rate Following Exercise-Induced Hyperthermia: A Randomized Counter-Balanced Crossover Study.,"Background and objectives:  Exertional heat stroke (EHS) is a potentially lethal, hyperthermic condition that warrants immediate cooling to optimize the patient outcome. The study aimed to examine if a portable cooling vest meets the established cooling criteria (0.15 °C·min -1  or greater) for EHS treatment. It was hypothesized that a cooling vest will not meet the established cooling criteria for EHS treatment.  Materials and Methods:  Fourteen recreationally active participants (mean ± SD; male,  n  = 8; age, 25 ± 4 years; body mass, 86.7 ± 10.5 kg; body fat, 16.5 ± 5.2%; body surface area, 2.06 ± 0.15 m 2 . female,  n  = 6; 22 ± 2 years; 61.3 ± 6.7 kg; 22.8 ± 4.4%; 1.66 ± 0.11 m 2 ) exercised on a motorized treadmill in a hot climatic chamber (ambient temperature 39.8 ± 1.9 °C, relative humidity 37.4 ± 6.9%) until they reached rectal temperature (T RE ) >39 °C (mean T RE , 39.59 ± 0.38 °C). Following exercise, participants were cooled using either a cooling vest (VEST) or passive rest (PASS) in the climatic chamber until T RE  reached 38.25 °C. Trials were assigned using randomized, counter-balanced crossover design.  Results:  There was a main effect of cooling modality type on cooling rates (F[1, 24] = 10.46,  p  < 0.01, η 2 p  = 0.30), with a greater cooling rate observed in VEST (0.06 ± 0.02 °C·min -1 ) than PASS (0.04 ± 0.01 °C·min -1 ) (MD = 0.02, 95% CI = [0.01, 0.03]). There were also main effects of sex (F[1, 24] = 5.97,  p  = 0.02, η 2 p  = 0.20) and cooling modality type (F[1, 24] = 4.38,  p  = 0.047, η 2 p  = 0.15) on cooling duration, with a faster cooling time in female (26.9 min) than male participants (42.2 min) (MD = 15.3 min, 95% CI = [2.4, 28.2]) and faster cooling duration in VEST than PASS (MD = 13.1 min, 95% CI = [0.2, 26.0]). An increased body mass was associated with a decreased cooling rate in PASS (r = -0.580,  p  = 0.03); however, this association was not significant in vest (r = -0.252,  p  = 0.39).  Conclusions:  Although VEST exhibited a greater cooling capacity than PASS, VEST was far below an acceptable cooling rate for EHS treatment. VEST should not replace immediate whole-body cold-water immersion when EHS is suspected.",2020,"There was a main effect of cooling modality type on cooling rates (F[1, 24] = 10.46,  p  < 0.01, η 2 p  = 0.30), with a greater cooling rate observed in VEST (0.06 ± 0.02","['female,  n  = 6; 22 ± 2 years; 61.3 ± 6.7 kg; 22.8 ± 4.4%; 1.66 ± 0.11 m 2 ) exercised on a', 'Fourteen recreationally active participants (mean ± SD; male,  n  = 8; age, 25 ± 4 years; body mass, 86.7 ± 10.5 kg; body fat, 16.5 ± 5.2%; body surface area, 2.06 ± 0.15 m 2 ']","['VEST', '°C·min -1 ', 'cooling vest (VEST) or passive rest (PASS', 'Exercise-Induced Hyperthermia', 'motorized treadmill in a hot climatic chamber']","['cooling rate', 'cooling rates', 'faster cooling duration', 'cooling rate in PASS', 'Cooling Rate', 'faster cooling time in female', 'cooling capacity', 'cooling duration', 'body mass']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C4517510', 'cui_str': '1.66'}, {'cui': 'C4517425', 'cui_str': '0.11'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C4068886', 'cui_str': '0.15'}]","[{'cui': 'C0453884', 'cui_str': 'Vest'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0444519', 'cui_str': 'Hot'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",,0.144512,"There was a main effect of cooling modality type on cooling rates (F[1, 24] = 10.46,  p  < 0.01, η 2 p  = 0.30), with a greater cooling rate observed in VEST (0.06 ± 0.02","[{'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Hosokawa', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Saitama 359-1192, Japan.'}, {'ForeName': 'Luke N', 'Initials': 'LN', 'LastName': 'Belval', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX 75231, USA.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Adams', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC 27412, USA.'}, {'ForeName': 'Lesley W', 'Initials': 'LW', 'LastName': 'Vandermark', 'Affiliation': 'Department of Health, Human Performance, and Recreation, University of Arkansas, Fayetteville, AR 72701, USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Casa', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, Storrs, CT 06269, USA.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56100539']
1173,33066554,The Impact of Time-Restricted Diet on Sleep and Metabolism in Obese Volunteers.,"Background and objectives:  A time-restricted diet is one of the various ways to improve metabolic condition and weight control. However, until now, there have been few pieces of evidence and research to verify the methods and effectiveness of time-restricted diets on metabolic improvement and health promoting. We designed this study to make a healthy diet program and to verify the effectiveness of a time-restricted diet on general health, including sleep and metabolism, in healthy volunteers.  Materials and Methods : This study was conducted in healthy adults who are obese but do not have related metabolic disease. Fifteen participants were recruited. Before and after this program, serologic tests including ketone level, questionnaires-daytime sleepiness evaluation such as the Epworth sleepiness scale and the Stanford sleepiness scale, the Korean version of the Pittsburgh sleep questionnaire index, STOP BANG to evaluate sleep apnea, the Hospital Anxiety and Depression Scale for emotion/sleep-and polysomnography (PSG) were conducted to evaluate the effects on sleep of the program. They were divided into two groups based on ketone levels that could reflect the constancy of participation in this study. We analyzed the before and after results of each group.  Results:  Fifteen participants (nine males and six females) completed this program without significant adverse events. Body weight after this program decreased to 78.2 ± 14.1 from 82.0 ± 15.6 kg ( p  = 0.539), and BMI decreased to 27.9 ± 3.8 from 29.3 ± 4.6 kg/m 2  ( p  = 0.233). Weight loss was observed in 14 subjects except 1 participant. The results from questionnaires before and after this were not significant changes. They were classified into high/low-ketone groups according to the ketone level of the participants. In the results of the PSG, the apnea hypopnea index (25.27 ± 12.67→15.11 ± 11.50/hr,  p  = 0.25) and oxygen desaturation (18.43 ± 12.79→10.69 ± 10.0/hr,  p  = 0.004), which are indicators of sleep apnea, also improved in the high-ketone group, compared with the low-ketone group. Satisfaction interviews for this restricted diet program showed that 86% of the participants were willing to participate in the same program again.  Conclusion:  The time-restricted diet was successful in weight loss for a period of 4 weeks in obese participants, which did not affect the efficiency and architecture of sleep. In addition, successful weight loss and significant improvement of sleep apnea were showed in the high-ketone group. Further research is needed to demonstrate mechanisms for weight loss, sleep apnea, and time-restricted diets.",2020,"The time-restricted diet was successful in weight loss for a period of 4 weeks in obese participants, which did not affect the efficiency and architecture of sleep.","['14 subjects except 1 participant', 'Fifteen participants (nine males and six females', 'healthy volunteers', 'healthy adults who are obese but do not have related metabolic disease', 'Fifteen participants were recruited', 'Obese Volunteers']","['healthy diet program', 'Materials and Methods ', 'Time-Restricted Diet', 'time-restricted diet']","['BMI', 'Sleep and Metabolism', 'weight loss', 'apnea hypopnea index', 'sleep apnea', 'oxygen desaturation', 'successful weight loss', 'efficiency and architecture of sleep', 'ketone level, questionnaires-daytime sleepiness evaluation such as the Epworth sleepiness scale and the Stanford sleepiness scale, the Korean version of the Pittsburgh sleep questionnaire index, STOP BANG to evaluate sleep apnea, the Hospital Anxiety and Depression Scale for emotion/sleep-and polysomnography (PSG', 'Weight loss', 'Body weight']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025517', 'cui_str': 'Metabolic disease'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0302363', 'cui_str': 'Infection due to Brucella abortus'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",15.0,0.0125746,"The time-restricted diet was successful in weight loss for a period of 4 weeks in obese participants, which did not affect the efficiency and architecture of sleep.","[{'ForeName': 'Hyeyun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': ""The Convergence Institute of Healthcare and Medical Science, Department of Neurology, Catholic Kwandong University, International St. Mary's Hospital, Incheon 22711, Korea.""}, {'ForeName': 'Bong Jin', 'Initials': 'BJ', 'LastName': 'Jang', 'Affiliation': 'Department of Medical Business Administration, Daegu Hanny University, Gyeongsangbuk-Do 38610, Korea.'}, {'ForeName': 'A Ram', 'Initials': 'AR', 'LastName': 'Jung', 'Affiliation': ""Department of Nutrition Management, Catholic Kwandong University, International St. Mary's Hospital, Incheon 22711, Korea.""}, {'ForeName': 'Jayoung', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': ""Department of Laboratory Medicine, Catholic Kwandong University, International St. Mary's Hospital, Incheon 22711, Korea.""}, {'ForeName': 'Hyo Jin', 'Initials': 'HJ', 'LastName': 'Ju', 'Affiliation': 'The Convergence Institute of Healthcare and Medical Science, College of Medicine, Catholic Kwandong University, Incheon 22711, Korea.'}, {'ForeName': 'Yeong In', 'Initials': 'YI', 'LastName': 'Kim', 'Affiliation': ""The Convergence Institute of Healthcare and Medical Science, Department of Neurology, Catholic Kwandong University, International St. Mary's Hospital, Incheon 22711, Korea.""}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56100540']
1174,33066593,Exercise Intensity May Not Moderate the Acute Effects of Functional Circuit Training on Cognitive Function: A Randomized Crossover Trial.,"Functional circuit training (FCT) has been demonstrated to acutely enhance cognitive performance (CP). However, the moderators of this observation are unknown. This study aimed to elucidate the role of exercise intensity. According to an a priori sample size calculation,  n  = 24 healthy participants (26 ± 3 years, 13 females), in randomized order, performed a single 15-min bout of FCT with low (20-39% of the heart rate reserve/HRR), moderate (40-59% HRR) or high intensity (maximal effort). Immediately pre- and post-workout, CP was measured by use of the Digit Span test, Stroop test and Trail Making test. Non-parametric data analyses did not reveal significant differences between conditions ( p  > 0.05) although parameter-free 95% confidence intervals showed pre-post improvements in some outcomes at moderate and high intensity only. The effort level does not seem to be a major effect modifier regarding short-term increases in CP following HCT in young active adults.",2020,The effort level does not seem to be a major effect modifier regarding short-term increases in CP following HCT in young active adults.,"['24 healthy participants (26 ± 3 years, 13 females', 'young active adults']","['Functional Circuit Training', 'Functional circuit training (FCT']",['Cognitive Function'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",24.0,0.0300091,The effort level does not seem to be a major effect modifier regarding short-term increases in CP following HCT in young active adults.,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wilke', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt, 60488 Frankfurt am Main, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Royé', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt, 60488 Frankfurt am Main, Germany.'}]",Brain sciences,['10.3390/brainsci10100738']
1175,33065651,Sentinel Node Biopsy alone or with Axillary Dissection in Breast Cancer Patients after Primary Chemotherapy: Long-term Results of a Prospective Interventional Study.,"OBJECTIVE


To ascertain, in cN0/1 breast cancer patients given primary chemotherapy followed by sentinel node biopsy (SNB), whether SNB alone is adequate axillary treatment if the sentinel nodes (SNs) are clear (pN0).
SUMMARY BACKGROUND DATA


2020 guidelines do not recommend SNB in most cN1 patients with clear SNs after primary chemotherapy because the high SNB false negative rate might lead to poorer outcomes.
METHODS


We prospectively assigned SNB after primary chemotherapy to 353 consecutive cT2 cN0/1 patients, median age 47 years (range 22-76) treated from 2007 to 2015. If the SNs were pN0, patients generally received no further axillary treatment (SNB only); if the SNs were pN1, completion AD (SNB + AD) was usually performed. Primary outcomes were overall (OS) and disease-free (DFS) survival in SNB only vs SNB + AD patients, assessed by Kaplan-Meier and compared using log-rank test, with use of propensity scores to account for bias due to non-random assignment to SNB vs SNB + AD.
RESULTS


Median follow-up was 108 months, interquartile range 66-136. OS and DFS did not differ significantly between the groups by propensity score-weighted comparison: 10-year OS 89% (95%CI: 81-99%) in SNB only patients vs 86% (95%CI: 78-95%) in SNB + AD patients; 10-year DFS 79% (95%CI: 68-92%) vs 69% (95%CI: 58-81%). No SNB-only patient developed axillary failure.
CONCLUSIONS


cT2 cN0/1 patients whose SNs are disease-free (pN0) after primary chemotherapy can be offered SNB (with no further axillary treatment if the SNs are negative), irrespective of axillary status beforehand, without affecting OS or DFS.",2020,OS and DFS did not differ significantly between the groups by propensity score-weighted comparison: 10-year OS 89% (95%CI: 81-99%) in SNB only patients vs 86% (95%CI: 78-95%) in SNB + AD patients; 10-year DFS 79% (95%CI: 68-92%) vs 69% (95%CI: 58-81%).,"['353 consecutive cT2 cN0/1 patients, median age 47 years (range 22-76) treated from 2007 to 2015', 'Breast Cancer Patients after Primary Chemotherapy', 'cN0/1 breast cancer patients given primary chemotherapy followed by sentinel node biopsy (SNB), whether']","['Sentinel Node Biopsy alone or with Axillary Dissection', 'SNB alone']","['overall (OS) and disease-free (DFS) survival', 'axillary failure', 'OS and DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}]","[{'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",,0.0564777,OS and DFS did not differ significantly between the groups by propensity score-weighted comparison: 10-year OS 89% (95%CI: 81-99%) in SNB only patients vs 86% (95%CI: 78-95%) in SNB + AD patients; 10-year DFS 79% (95%CI: 68-92%) vs 69% (95%CI: 58-81%).,"[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Martelli', 'Affiliation': 'Breast Unit, Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Barretta', 'Affiliation': 'Unit of Clinical Epidemiology and Trial Organization, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Miceli', 'Affiliation': 'Unit of Clinical Epidemiology and Trial Organization, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Secondo', 'Initials': 'S', 'LastName': 'Folli', 'Affiliation': 'Breast Unit, Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Maugeri', 'Affiliation': 'Breast Unit, Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Listorti', 'Affiliation': 'Breast Unit, Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Scaperrotta', 'Affiliation': 'Breast Unit, Imaging, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Baili', 'Affiliation': 'Analytical Epidemiology and Health Impact Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Pruneri', 'Affiliation': 'Breast Unit, Pathology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Capri', 'Affiliation': 'Breast Unit, Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ferraris', 'Affiliation': 'Breast Unit, Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}]",Annals of surgery,['10.1097/SLA.0000000000004562']
1176,33065663,Taylor Spatial Frame or Reamed Intramedullary Nailing for Closed Fractures of the Tibial Shaft: A Randomized Controlled Trial.,"OBJECTIVES


To compare a modern ring fixator [Taylor Spatial Frame (TSF)] and reamed intramedullary nailing (IMN) for the treatment of closed tibial shaft fractures.
DESIGN


Randomized controlled trial.
SETTING


Two university hospitals.
PATIENTS


Patients between 18 and 70 years of age surgically treated for an acute tibial shaft fracture.
INTERVENTION


TSF (n = 31) versus a reamed intramedullary nail (n = 32). The patients were followed up for 2 years.
MAIN OUTCOME MEASUREMENTS


The physical component summary of Short Form 36 (SF-36) at 2 years was the primary outcome measure. Secondary outcomes included the other components of the SF-36, pain assessed by a visual analogue scale (VAS), complications, and resource consumption.
RESULTS


The mean age was 43 years (SD 14.0), and 42 (67%) were men. The physical component summary at 2 years was 52.4 (SD 6.3) in the TSF group and 53.3 (SD 8.0) in the IMN group (P = 0.35). There were modest differences in the other SF-36 scores during the follow-up period. Up to and including 12 months, the TSF group had less knee pain [at 12 months: VAS 0.5 (SD 1.2) vs. VAS 2.4 (SD 2.2; P < 0.001)], but this was not statistically significant at 24 months [VAS 0.7 (SD 1.4) vs. VAS 1.5 (SD 2.0; P = 0.11)]. Superficial skin infections were more frequent in the TSF group [22 (71%) vs. 4 (13%); P < 0.001]. The number of other complications was similar between the groups.
CONCLUSIONS


Both TSF and IMN provided good clinical results. TSF had more pin-track infections but less knee pain the first year.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,Superficial skin infections were more frequent in the TSF group [22 (71%) vs. 4 (13%); P < 0.001].,"['Closed Fractures of the Tibial Shaft', 'Patients between 18 and 70 years of age surgically treated for an acute tibial shaft fracture', 'The mean age was 43 years (SD 14.0), and 42 (67%) were men', 'closed tibial shaft fractures', 'Two university hospitals']","['Taylor Spatial Frame or Reamed Intramedullary Nailing', 'reamed intramedullary nail', 'modern ring fixator [Taylor Spatial Frame (TSF', 'TSF', 'reamed intramedullary nailing (IMN']","['pin-track infections', 'other components of the SF-36, pain assessed by a visual analogue scale (VAS), complications, and resource consumption', 'number of other complications', 'knee pain', 'Superficial skin infections', 'SF-36 scores']","[{'cui': 'C0016659', 'cui_str': 'Fracture, closed'}, {'cui': 'C0588199', 'cui_str': 'Bone structure of shaft of tibia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C2606415', 'cui_str': 'ZDHHC2 protein, human'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0441254', 'cui_str': 'Fixation device'}]","[{'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.112105,Superficial skin infections were more frequent in the TSF group [22 (71%) vs. 4 (13%); P < 0.001].,"[{'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Frihagen', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jan E', 'Initials': 'JE', 'LastName': 'Madsen', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Sundfeldt', 'Affiliation': 'Orthopaedic Department, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Gunnar B', 'Initials': 'GB', 'LastName': 'Flugsrud', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Joakim S', 'Initials': 'JS', 'LastName': 'Andreassen', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Mette R', 'Initials': 'MR', 'LastName': 'Andersen', 'Affiliation': 'Department of Orthopaedic Surgery, Baerum Hospital, Vestre Viken Hospital Trust, Norway.'}, {'ForeName': 'Geir S', 'Initials': 'GS', 'LastName': 'Andreassen', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001802']
1177,33065702,Compression Socks Reduce Running-Induced Intestinal Damage.,"Zadow, EK, Edwards, KH, Kitic, CM, Fell, JW, Adams, MJ, Singh, I, Kundur, A, Johnstone, ANB, Crilly, J, Bulmer, AC, Halson, SL, and, and Wu, SSX. Compression socks reduce running-induced intestinal damage. J Strength Cond Res XX(X): 000-000, 2020-Exercise is associated with a reduction in splanchnic blood flow that leads to the disruption of intestinal epithelium integrity, contributing to exercise-induced gastrointestinal syndrome. Strategies that promote intestinal blood flow during exercise may reduce intestinal damage, which may be advantageous for subsequent recovery and performance. This study aimed to explore if exercise-associated intestinal damage was influenced by wearing compression garments, which may improve central blood flow. Subjects were randomly allocated to wear compression socks (n = 23) or no compression socks (control, n = 23) during a marathon race. Blood samples were collected 24 hours before and immediately after marathon and analyzed for intestinal fatty acid-binding protein (I-FABP) concentration as a marker of intestinal damage. The magnitude of increase in postmarathon plasma I-FABP concentration was significantly greater in control group (107%; 95% confidence interval [CI], 72-428%) when compared with runners wearing compression socks (38%; 95% CI, 20-120%; p = 0.046; d = 0.59). Wearing compression socks during a marathon run reduced exercise-associated intestinal damage. Compression socks may prove an effective strategy to minimize the intestinal damage component of exercise-induced gastrointestinal syndrome.",2020,"The magnitude of increase in postmarathon plasma I-FABP concentration was significantly greater in control group (107%; 95% confidence interval [CI], 72-428%) when compared with runners wearing compression socks (38%; 95% CI, 20-120%; p = 0.046; d = 0.59).",[],"['wear compression socks (n = 23) or no compression socks (control, n = 23) during a marathon race', 'J Strength Cond Res XX(X', 'Compression socks']","['postmarathon plasma I-FABP concentration', 'Blood samples', 'central blood flow']",[],"[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0445269', 'cui_str': 'Socks'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168374', 'cui_str': 'Marathon composite resin'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",,0.0504263,"The magnitude of increase in postmarathon plasma I-FABP concentration was significantly greater in control group (107%; 95% confidence interval [CI], 72-428%) when compared with runners wearing compression socks (38%; 95% CI, 20-120%; p = 0.046; d = 0.59).","[{'ForeName': 'Emma K', 'Initials': 'EK', 'LastName': 'Zadow', 'Affiliation': 'Holsworth Research Initiative, College Science Health and Engineering, La Trobe Rural Health School, La Trobe University, Bendigo, Australia.'}, {'ForeName': 'Kate H', 'Initials': 'KH', 'LastName': 'Edwards', 'Affiliation': 'School of Health Sciences, Sports Performance Optimization Research Team, University of Tasmania, Launceston, Australia.'}, {'ForeName': 'Cecilia M', 'Initials': 'CM', 'LastName': 'Kitic', 'Affiliation': 'School of Health Sciences, Sports Performance Optimization Research Team, University of Tasmania, Launceston, Australia.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Fell', 'Affiliation': 'School of Health Sciences, Sports Performance Optimization Research Team, University of Tasmania, Launceston, Australia.'}, {'ForeName': 'Murray J', 'Initials': 'MJ', 'LastName': 'Adams', 'Affiliation': 'School of Health Sciences, Sports Performance Optimization Research Team, University of Tasmania, Launceston, Australia.'}, {'ForeName': 'Indu', 'Initials': 'I', 'LastName': 'Singh', 'Affiliation': 'Menzies Health Institute Queensland and School of Medical Science, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Kundur', 'Affiliation': 'Menzies Health Institute Queensland and School of Medical Science, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Amy N B', 'Initials': 'ANB', 'LastName': 'Johnston', 'Affiliation': 'Department of Emergency Medicine, Gold Coast Health, Gold Coast, Australia.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Crilly', 'Affiliation': 'School of Nursing and Midwifery and Menzies Health Institute, Queensland, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Bulmer', 'Affiliation': 'Menzies Health Institute Queensland and School of Medical Science, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Shona L', 'Initials': 'SL', 'LastName': 'Halson', 'Affiliation': 'Department of Physiology, Australian Institute of Sport, Belconnen, Australia.'}, {'ForeName': 'Sam S X', 'Initials': 'SSX', 'LastName': 'Wu', 'Affiliation': 'School of Health Sciences, Sports Performance Optimization Research Team, University of Tasmania, Launceston, Australia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003870']
1178,33065708,Effects of Combined Strength and Resisted Sprint Training on Physical Performance in U-19 Elite Soccer Players.,"Ben Brahim, M, Bougatfa, R, Makni, E, Gonzalez, PP, Yasin, H, Tarwneh, R, Moalla, W, and Elloumi, M. Effects of combined strength and resisted sprint training on physical performance in U-19 elite soccer players. J Strength Cond Res XX(X): 000-000, 2020-This study assessed the effects of combined muscular strength and resisted sprint training using both sled and weight vest compared with regular soccer training on physical fitness of lower limbs in U-19 elite soccer players. Thirty-four male soccer players (age: 18.8 ± 0.8 years, height: 1.81 ± 0.05 m, body mass: 76.4 ± 4.9 kg, and body fat mass: 11.3 ± 4.2%) were randomly assigned into a resisted sprint training group (RSTG, n = 20), using both weight vest and sled, and a control group (CONTG, n = 14). Sprinting ability (5 m and 20 m), squat jump (SJ) and counter-movement jump (CMJ) tests, 1 repetition maximum of half-back squat (1RM half-back squat), and soccer ball-shooting speed were assessed before and after a 6-week training program. Within-group interactions showed significant combined muscular strength and resisted sprint training effects were observed for all the tests' measurements (effect sizes = 0.97 and 3.69 for 20-m sprint and SJ, respectively). However, significant increases of performances were observed for 5-m and 20-m sprinting time ( = 0.25, p < 0.01 and = 0.22, p < 0.01, respectively), SJ and CMJ ( = 0.78, p < 0.0001 and = 0.34, p < 0.001, respectively), 1 repetition maximum (1-RM) half-back squat ( = 0.45, p < 0.0001), and soccer ball-shooting speed ( = 0.41, p < 0.0001) in RSTG with large effect size, whereas the CONTG showed significant performances increase only for CMJ (p < 0.05), 1RM half-back squat (p < 0.01), and soccer ball-shooting speed (p < 0.05). We conclude that combined strength and both horizontal (weighted sled) and vertical (weighted vest) resisted sprint training are more effective than regular soccer training for enhancing sprinting and jumping abilities as well as ball-shooting speed in soccer.",2020,"Within-group interactions showed significant combined muscular strength and resisted sprint training effects were observed for all the tests' measurements (effect sizes = 0.97 and 3.69 for 20-m sprint and SJ, respectively).","['U-19 Elite Soccer Players', 'U-19 elite soccer players', 'Thirty-four male soccer players (age: 18.8 ± 0.8 years, height: 1.81 ± 0.05 m, body mass: 76.4 ± 4.9 kg, and body fat mass: 11.3 ± 4.2']","['combined strength and both horizontal (weighted sled) and vertical (weighted vest) resisted sprint training', 'regular soccer training', 'Combined Strength and Resisted Sprint Training', 'resisted sprint training', 'J Strength Cond Res XX(X', 'combined muscular strength and resisted sprint training using both sled and weight vest compared with regular soccer training', 'sprint training']","['Ben Brahim, M, Bougatfa, R, Makni, E, Gonzalez, PP, Yasin, H, Tarwneh, R, Moalla, W, and Elloumi, M. Effects of combined strength', 'Physical Performance', 'CMJ', '1RM half-back squat', 'Sprinting ability (5 m and 20 m), squat jump (SJ) and counter-movement jump (CMJ) tests, 1 repetition maximum of half-back squat (1RM half-back squat), and soccer ball-shooting speed', 'soccer ball-shooting speed', '1 repetition maximum (1-RM) half-back squat', 'combined muscular strength and resisted sprint training effects']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C4517758', 'cui_str': '4.2'}]","[{'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0336980', 'cui_str': 'Sledding'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0453884', 'cui_str': 'Vest'}, {'cui': 'C0454374', 'cui_str': 'Sprint training'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]","[{'cui': 'C0004698', 'cui_str': 'Balkan nephropathy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0336986', 'cui_str': 'Soccer ball'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0454374', 'cui_str': 'Sprint training'}]",34.0,0.0254505,"Within-group interactions showed significant combined muscular strength and resisted sprint training effects were observed for all the tests' measurements (effect sizes = 0.97 and 3.69 for 20-m sprint and SJ, respectively).","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Ben Brahim', 'Affiliation': 'Health and Physical Education Department, Prince Sultan University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Rim', 'Initials': 'R', 'LastName': 'Bougatfa', 'Affiliation': 'Department of Basic Medical Sciences, Alfarabi College of Medicine, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Emna', 'Initials': 'E', 'LastName': 'Makni', 'Affiliation': 'University of Sousse, Laboratory of Cardio-circulatory, Respiratory, and Hormonal Adaptations to Muscular Exercise, Faculty of Medicine Ibn El Jazzar, Sousse, Tunisia.'}, {'ForeName': 'Pablo Prieto', 'Initials': 'PP', 'LastName': 'Gonzalez', 'Affiliation': 'Health and Physical Education Department, Prince Sultan University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Hussain', 'Initials': 'H', 'LastName': 'Yasin', 'Affiliation': 'Health and Physical Education Department, Prince Sultan University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Raghad', 'Initials': 'R', 'LastName': 'Tarwneh', 'Affiliation': 'Health and Physical Education Department, Prince Sultan University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Wassim', 'Initials': 'W', 'LastName': 'Moalla', 'Affiliation': 'UR15JS01, Education, Motricity, Sport and Health, High Institute of Sport and Physical Education, Sfax University, Tunisia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elloumi', 'Affiliation': 'Health and Physical Education Department, Prince Sultan University, Riyadh, Kingdom of Saudi Arabia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003829']
1179,33065955,"Safety of IncobotulinumtoxinA in the Treatment of Facial Lines: Results From a Pooled Analysis of Randomized, Prospective, Controlled Clinical Studies.","BACKGROUND


The safety and efficacy of incobotulinumtoxinA in aesthetics has been established in multiple studies. Although individual studies have been reported, a combined assessment of incobotulinumtoxinA safety across studies is not available.
OBJECTIVE


To assess the frequency of adverse events (AEs) across prospective incobotulinumtoxinA studies in aesthetics.
MATERIALS AND METHODS


Safety data were assessed from 9 placebo-controlled or active-controlled single-dose studies on glabellar frown lines (GFL), crow's feet (CF), and upper facial lines (UFL). Analyses by treatment cycle included 4 repeat-dose studies on GFL and UFL.
RESULTS


One thousand three hundred seventy-seven subjects received incobotulinumtoxinA (GFL, n = 1,189; CF, n = 83; UFL, n = 105) in single-dose studies (placebo-controlled studies: incobotulinumtoxinA, n = 866; placebo, n = 395). Over 1,000 subjects received incobotulinumtoxinA in repeat-dose studies (GFL, n = 880; UFL, n = 290). In placebo-controlled single-dose studies, incidences of treatment-related AEs ranged from 5.4% (GFL) to 22.9% (UFL). The most frequent treatment-related AE in single-dose studies was headache (GFL, 4.8%; UFL, 11.4%). In repeat-dose studies, incidence of AEs was highest during cycle 1 (GFL, 8.9%; UFL, 17.2%) and decreased across treatment cycles. No serious treatment-related AEs were observed.
CONCLUSION


Results confirm the favorable safety and tolerability of incobotulinumtoxinA. The frequency of treatment-related AEs was low and may decrease with subsequent treatments.",2017,"No serious treatment-related AEs were observed.
","['One thousand three hundred seventy-seven subjects received', 'Facial Lines']","['incobotulinumtoxinA', 'placebo', 'IncobotulinumtoxinA', 'incobotulinumtoxinA (GFL', 'placebo-controlled or active-controlled single-dose studies']","['favorable safety and tolerability', 'incidence of AEs', ""glabellar frown lines (GFL), crow's feet (CF), and upper facial lines (UFL""]","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0948887', 'cui_str': 'Glabellar frown lines'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0948887', 'cui_str': 'Glabellar frown lines'}, {'cui': 'C0277939', 'cui_str': ""Crow's feet""}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]",1377.0,0.0805992,"No serious treatment-related AEs were observed.
","[{'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Coleman', 'Affiliation': '*Coleman Cosmetic Dermatologic Surgery Center, Metairie, Louisiana; †Rosenpark Klinik, Darmstadt, Germany; ‡Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany; §Merz North America, Inc., Raleigh, North Carolina.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Sattler', 'Affiliation': ''}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Weissenberger', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Hast', 'Affiliation': ''}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Hanschmann', 'Affiliation': ''}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000001409']
1180,33065990,Socio-Demographic Characteristics and Body Weight Perceptions of Study Participants Benefitting Most from the Feel4Diabetes Program Based on Their Anthropometric and Glycaemic Profile Changes.,"The Feel4Diabetes program was comprised of a community-based screening and a two-year intervention phase aiming to prevent type 2 diabetes (T2D) in families at risk for diabetes across Europe. The current work aimed to identify the socio-demographic characteristics and body weight perceptions of participants who benefitted the most, achieving at least a 5% reduction in body weight, waist circumference and glycaemic indices (fasting plasma glucose, insulin, glycosylated haemoglobin levels), over two-year period. Following a two-stage screening procedure, 2294 high-risk parents were randomly allocated to standard care or more intensive intervention. The participants who benefitted most were living in Southern (OR 2.39-3.67,  p  < 0.001) and Eastern Europe (OR 1.55-2.47,  p  < 0.05), received more intensive intervention (OR 1.53-1.90,  p  = 0.002) and were younger (<40 years old) adults (OR 1.48-1.51,  p  < 0.05). Furthermore, individuals with tertiary education (OR 2.06,  p  < 0.001), who were unemployed (OR 1.62-1.68,  p  < 0.05) and perceived their body weight to be higher than normal (OR 1.58-3.00,  p  < 0.05) were more likely to benefit from the program. Lastly, males were more likely to show improvements in their glycaemic profiles compared to females (OR 1.40,  p  = 0.024). These findings point out the regions in Europe and the sociodemographic profile of individuals that benefitted the most in the current study, highlighting the need to prioritise regions in greater need for such interventions and also tailor future interventions to the characteristics and perceptions of the target populations.",2020,"The participants who benefitted most were living in Southern (OR 2.39-3.67,  p  < 0.001) and Eastern Europe (OR 1.55-2.47,  p  < 0.05), received more intensive intervention (OR 1.53-1.90,  p  = 0.002) and were younger (<40 years old) adults (OR 1.48-1.51,  p  < 0.05).",['2294 high-risk parents'],"['standard care or more intensive intervention', 'Feel4Diabetes Program']","['glycaemic profiles', 'body weight, waist circumference and glycaemic indices (fasting plasma glucose, insulin, glycosylated haemoglobin levels', 'body weight', 'Socio-Demographic Characteristics and Body Weight Perceptions']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",2294.0,0.0350729,"The participants who benefitted most were living in Southern (OR 2.39-3.67,  p  < 0.001) and Eastern Europe (OR 1.55-2.47,  p  < 0.05), received more intensive intervention (OR 1.53-1.90,  p  = 0.002) and were younger (<40 years old) adults (OR 1.48-1.51,  p  < 0.05).","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Moschonis', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, VIC 3086, Australia.'}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Karatzi', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 17671 Athens, Greece.'}, {'ForeName': 'Kyriaki', 'Initials': 'K', 'LastName': 'Apergi', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 17671 Athens, Greece.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Liatis', 'Affiliation': 'National and Kapodistrian University of Athens Medical School, 11527 Athens, Greece.'}, {'ForeName': 'Jemina', 'Initials': 'J', 'LastName': 'Kivelä', 'Affiliation': 'Department of Public Health Solutions, Finnish Institute for Health and Welfare, 00271 Helsinki, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wikström', 'Affiliation': 'Department of Public Health Solutions, Finnish Institute for Health and Welfare, 00271 Helsinki, Finland.'}, {'ForeName': 'Alelí M', 'Initials': 'AM', 'LastName': 'Ayala-Marín', 'Affiliation': 'Growth, Exercise, Nutrition and Development (GENUD) Research Group, Instituto Agroalimentario de Aragón (IA2), Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Mateo-Gallego', 'Affiliation': 'Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Kaloyan', 'Initials': 'K', 'LastName': 'Tsochev', 'Affiliation': 'Department of Paediatrics, Medical University Varna, 9002 Varna, Bulgaria.'}, {'ForeName': 'Nevena', 'Initials': 'N', 'LastName': 'Chakarova', 'Affiliation': 'Clinical Center of Endocrinology, Department of Diabetology, Medical University Sofia, 1431 Sofia, Bulgaria.'}, {'ForeName': 'Emese', 'Initials': 'E', 'LastName': 'Antal', 'Affiliation': 'Hungarian Society of Nutrition, 1088 Budapest, Hungary.'}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Rurik', 'Affiliation': 'Hungarian Society of Nutrition, 1088 Budapest, Hungary.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Iotova', 'Affiliation': 'Department of Paediatrics, Medical University Varna, 9002 Varna, Bulgaria.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Cardon', 'Affiliation': 'Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, 9000 Gent, Belgium.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Lindstrom', 'Affiliation': 'Department of Public Health Solutions, Finnish Institute for Health and Welfare, 00271 Helsinki, Finland.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Moreno', 'Affiliation': 'Growth, Exercise, Nutrition and Development (GENUD) Research Group, Instituto Agroalimentario de Aragón (IA2), Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Makrilakis', 'Affiliation': 'National and Kapodistrian University of Athens Medical School, 11527 Athens, Greece.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 17671 Athens, Greece.'}]",Nutrients,['10.3390/nu12103117']
1181,33066009,Choline Intake as Supplement or as a Component of Eggs Increases Plasma Choline and Reduces Interleukin-6 without Modifying Plasma Cholesterol in Participants with Metabolic Syndrome.,"Metabolic syndrome (MetS) is characterized by low-grade inflammation and insulin resistance, which increase the risk of heart disease. Eggs have numerous nutrients including choline, carotenoids, and fat-soluble vitamins that may protect against these conditions. Egg phosphatidylcholine (PC) is a major contributor of dietary choline in the American diet. However, uncertainty remains regarding eggs due to their high concentration of cholesterol. In this study, we evaluated the effect of two sources of choline, whole eggs (a source of PC) and a choline supplement (choline bitartrate, CB), on plasma lipids, glucose, insulin resistance, and inflammatory biomarkers. We recruited 23 subjects with MetS to participate in this randomized cross-over intervention. After a 2-week washout, with no choline intake, participants were randomly allocated to consume three eggs/day or CB (~400 mg choline/d for both) for 4 weeks. After a 3-week washout period, they were allocated to the alternate treatment. Dietary records indicated higher concentrations of vitamin E and selenium during the egg period ( p  < 0.01). Interestingly, there were no changes in plasma total, low density lipoprotein (LDL)- or high density lipoprotein (HDL)-cholesterol, triglycerides, or glucose, compared either to baseline or between treatments. In contrast, interleukin-6 was reduced, with both sources of choline compared to baseline, while eggs also had an effect on lowering C-reactive protein, insulin, and insulin resistance compared to baseline. This study demonstrates that in a MetS population, intake of three eggs per day does not increase plasma LDL cholesterol, and has additional benefits on biomarkers of disease compared to a choline supplement, possibly due to the presence of other antioxidants in eggs.",2020,Dietary records indicated higher concentrations of vitamin E and selenium during the egg period ( p  < 0.01).,"['Participants with Metabolic Syndrome', '23 subjects with MetS to participate in this randomized cross-over intervention']","['Egg phosphatidylcholine (PC', 'CB', 'choline, whole eggs (a source of PC) and a choline supplement (choline bitartrate, CB']","['concentrations of vitamin E and selenium', 'Metabolic syndrome (MetS', 'lowering C-reactive protein, insulin, and insulin resistance', 'plasma total, low density lipoprotein (LDL)- or high density lipoprotein (HDL)-cholesterol, triglycerides, or glucose', 'plasma lipids, glucose, insulin resistance, and inflammatory biomarkers', 'plasma LDL cholesterol']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C1959616', 'cui_str': 'Lecithin'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0008408', 'cui_str': 'Choline bitartrate'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1278149', 'cui_str': 'Plasma LDL cholesterol measurement'}]",23.0,0.0838643,Dietary records indicated higher concentrations of vitamin E and selenium during the egg period ( p  < 0.01).,"[{'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'DiBella', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Minu S', 'Initials': 'MS', 'LastName': 'Thomas', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Alyousef', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Millar', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Blesso', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Malysheva', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Caudill', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Maria Luz', 'Initials': 'ML', 'LastName': 'Fernandez', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}]",Nutrients,['10.3390/nu12103120']
1182,33066040,Effect of a Nutritional Support System (Diet and Supplements) for Improving Gross Motor Function in Cerebral Palsy: An Exploratory Randomized Controlled Clinical Trial.,"BACKGROUND


Most patients with cerebral palsy (CP) do not respond to physical therapy due to deterioration in their nutritional status, secondary to gastrointestinal disorders and the catabolic state of the disease itself. However, basic treatments only contemplate the energy requirements and do not consider supplementation with glutamine, zinc, selenium, colecalciferol, spirulina, omega 3 or even vegetal proteins.
OBJECTIVE


In this study, we determined the effect of using a nutritional support system (NSS): diet and supplements, on the gross motor function in children with CP with spastic diparesic and Gross Motor Function Classification System III (GMFCS III).
METHODS


An exploratory study was performed. Thirty patients (from 4 to 12 years old) were randomly assigned to: (1) dietary surveillance (FG), (2) deworming and WHO diet (CG), or (3) deworming and the NSS (IG). Gross motor function was evaluated using the gross motor function measure (GMFM) scale.
RESULTS


The IG-treated group presented a significant improvement in standing and walking parameters analyzed in the GMFM compared with FG and CG groups. Fifty percent of the IG-treated patients managed to walk, while in the other groups, no patients were able to walk.
CONCLUSIONS


The NSS used in the present work improves gross motor function and promotes walking in patients with CP.",2020,The IG-treated group presented a significant improvement in standing and walking parameters analyzed in the GMFM compared with FG and CG groups.,"['patients with cerebral palsy (CP', 'Thirty patients (from 4 to 12 years old', 'Cerebral Palsy', 'children with CP with spastic diparesic and Gross Motor Function Classification System III (GMFCS III', 'patients with CP']","['Nutritional Support System (Diet and Supplements', 'dietary surveillance (FG), (2) deworming and WHO diet (CG), or (3) deworming and the NSS (IG', 'nutritional support system (NSS): diet and supplements']","['standing and walking parameters', 'gross motor function measure (GMFM) scale', 'Gross motor function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0199859', 'cui_str': 'Deworming'}]","[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",30.0,0.017051,The IG-treated group presented a significant improvement in standing and walking parameters analyzed in the GMFM compared with FG and CG groups.,"[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Leal-Martínez', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Franco', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Peña-Ruiz', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Castro-Silva', 'Affiliation': 'Departamento de Terapia Física, Centro de Rehabilitación e Inclusión Infantil Teletón (CRIT), Tlalnepantla de Baz 54010, Mexico.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Escudero-Espinosa', 'Affiliation': 'Departamento de Terapia Física, Centro de Rehabilitación e Inclusión Infantil Teletón (CRIT), Tlalnepantla de Baz 54010, Mexico.'}, {'ForeName': 'Oscar G', 'Initials': 'OG', 'LastName': 'Rolón-Lacarrier', 'Affiliation': 'Departamento de Investigación y Enseñanza, Centro de Rehabilitación e Inclusión Infantil Teletón (CRIT), Tlalnepantla de Baz 54010, Mexico.'}, {'ForeName': 'Mardia', 'Initials': 'M', 'LastName': 'López-Alarcón', 'Affiliation': 'Unidad de Investigación Médica en Nutrición, Hospital de Pediatría CMN siglo XXI, Ciudad de Mexico 06720, Mexico.'}, {'ForeName': 'Ximena', 'Initials': 'X', 'LastName': 'De León', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Linares-Eslava', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ibarra', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}]","Foods (Basel, Switzerland)",['10.3390/foods9101449']
1183,33066601,Acute Effects of Self-Selected Music Intervention on Golf Performance and Anxiety Level in Collegiate Golfers: A Crossover Study.,"Music has been reported as a positive intervention for improving psychophysiological conditions and exercise performance. However, the effects of music intervention on golf performance in association with psychophysiological responses have not been well examined in the literature. The purpose of the study was to investigate the acute effects of self-selected music intervention on golf swing and putting performance, heart rate (HR), HR variability (HRV), and anxiety. Twenty collegiate golfers voluntarily participated in this study (age = 20.2 ± 1.4 years, height = 171.7 ± 8.0 cm, body weight = 69.5 ± 14.6 kg, golf experience = 7.5 ± 2.1 years). A cross-over and within-subject design was used in this study. Participants performed a non-music trial (T1), pre-exercise music trial (T2), and simultaneous music trial (T3) in a randomized order with 48-72 h apart. The participants were attached to a HR monitor to record the HR and HRV during the measurement. The golf swing and putting performance was assessed by using the Golfzon golf simulator system. The state-trait anxiety inventory-state questionnaire (STAI-S) was used to evaluate anxiety state. All measurements were taken during baseline (phase one) and after resting or music intervention (phase two). Repeated measurement of analysis of variance (ANOVA) and Cohen's effect size (ES) were used for statistical analyses. The results show no significant differences in golf swing and putting performance ( p  > 0.05). However, significant decrease in STAI-S score was found in T2 ( p  = 0.047, ES = 0.32). A significant increase in the standard deviation of normal R-R interval (SDNN), low-frequency power spectrum (LF), standard deviation of along the line-of-identity (SD2) in T2 and T3 were observed ( p  < 0.05). In conclusion, a single pre-exercise or simultaneous self-selected music intervention contributes minor effects to golf performance in collegiate golfers. The positive benefits of self-selected music intervention on the psychological condition and cardia-related modulation while practicing golf is warranted.",2020,"A significant increase in the standard deviation of normal R-R interval (SDNN), low-frequency power spectrum (LF), standard deviation of along the line-of-identity (SD2) in T2 and T3 were observed ( p  < 0.05).","['Twenty collegiate golfers voluntarily participated in this study (age = 20.2 ± 1.4 years, height = 171.7 ± 8.0 cm, body weight = 69.5 ± 14.6 kg, golf experience = 7.5 ± 2.1 years', 'Collegiate Golfers']","['Self-Selected Music Intervention', 'self-selected music intervention', 'music intervention']","['STAI-S score', 'golf swing and putting performance', 'standard deviation of normal R-R interval (SDNN), low-frequency power spectrum (LF), standard deviation of along the line-of-identity (SD2', 'Golf Performance and Anxiety Level', 'golf swing and putting performance, heart rate (HR), HR variability (HRV), and anxiety', 'state-trait anxiety inventory-state questionnaire (STAI-S']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517642', 'cui_str': '20.2'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018041', 'cui_str': 'Golfing'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4068876', 'cui_str': '2.1'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018041', 'cui_str': 'Golfing'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0512171,"A significant increase in the standard deviation of normal R-R interval (SDNN), low-frequency power spectrum (LF), standard deviation of along the line-of-identity (SD2) in T2 and T3 were observed ( p  < 0.05).","[{'ForeName': 'Hung-Tsung', 'Initials': 'HT', 'LastName': 'Wang', 'Affiliation': 'Graduate Institute of Sports Training, University of Taipei, Taipei 11153, Taiwan.'}, {'ForeName': 'Hsia-Ling', 'Initials': 'HL', 'LastName': 'Tai', 'Affiliation': 'Department of Physical Education, University of Taipei, Taipei 10048, Taiwan.'}, {'ForeName': 'Chia-Chen', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'Graduate Institute of Sports Training, University of Taipei, Taipei 11153, Taiwan.'}, {'ForeName': 'Yung-Sheng', 'Initials': 'YS', 'LastName': 'Chen', 'Affiliation': 'Department of Exercise and Health Sciences, University of Taipei, Taipei 11153, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17207478']
1184,33066723,"Exploratory Cross-Over, Trial of Augmented RLS with the Dopamine Receptor 1/5 Antagonist Ecopipam.","Restless legs syndrome is a common condition that initially responds dramatically to dopaminergic therapy. Over time, however, dopaminergics cause augmentation, where symptoms occur earlier and intensify. Animal models suggest this may result from increased dopamine receptor type-1 affinity in the spinal cord. Ecopipam is a potent, specific dopamine-1/5 receptor antagonist. We performed an small (N = 10) exploratory placebo controlled, cross-over safety trial of ecopipam (25-100mg/day) for patients with augmented restless legs syndrome currently taking dopamine agonists. Ecopipam was well tolerated with sedation being the most common adverse event in drug and placebo. Safety scales and serology data were similar to placebo.  The study was not powered to demonstrate efficacy and exploratory efficacy data showed no significant improvement compared to placebo, but RLS diaries, the international RLS rating scale, and clinical global impressions all favored drug . No subject worsened on drug or demonstrated rebound worsening after drug discontinuation. Ecopipam was safe and well tolerated in this initial study for restless legs syndrome. Given the lack of alternate options, larger efficacy studies for augmented restless legs syndrome, and potentially de novo restless legs syndrome are justified.",2020,"The study was not powered to demonstrate efficacy and exploratory efficacy data showed no significant improvement compared to placebo, but RLS diaries, the international RLS rating scale, and clinical global impressions all favored drug .",['patients with augmented restless legs syndrome currently taking'],"['dopamine agonists', 'Ecopipam', 'placebo', 'ecopipam']","['RLS diaries, the international RLS rating scale, and clinical global impressions', 'safe and well tolerated', 'Safety scales and serology data']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C1099053', 'cui_str': 'ecopipam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}]",,0.186238,"The study was not powered to demonstrate efficacy and exploratory efficacy data showed no significant improvement compared to placebo, but RLS diaries, the international RLS rating scale, and clinical global impressions all favored drug .","[{'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Ondo', 'Affiliation': 'Movement Disorders - Methodist Neurological Institute, Houston TX.'}, {'ForeName': 'Titilayo', 'Initials': 'T', 'LastName': 'Olubajo', 'Affiliation': 'Movement Disorders - Methodist Neurological Institute, Houston TX.'}]",The International journal of neuroscience,['10.1080/00207454.2020.1838515']
1185,33066735,The skill of tracheal intubation with rigid scopes - a randomised controlled trial comparing learning curves in 740 intubations.,"BACKGROUND


Rigid scopes are successfully used for management of difficult airways, but learning curves have not been established.
METHODS


This randomised controlled trial was performed at the University Hospital Bern in Switzerland to establish learning curves for the rigid scopes Bonfils and SensaScope and to assess their performance. Fifteen consultant anaesthetists and 15 anaesthesia registrars performed a total of 740 intubations (10 to 20 intubations with each device per physician) in adult patients without predictors of a difficult airway under general anaesthesia. According to randomisation, physicians intubated the patient's trachea with either the Bonfils or the SensaScope. A maximum of three intubation attempts was allowed. Primary outcome was overall time to successful intubation. Secondary outcome parameters included first attempt success, first attempt success within 60 s, failures and adverse events.
RESULTS


A clear learning effect was demonstrated: Over 20 trials, intubations became 2.5-times quicker and first attempt intubation success probability increased by 21-28 percentage points. Fourteen and 20 trials were needed with the Bonfils and the SensaScope, respectively, to reach a 90% first attempt success probability. Intubation times were 23% longer (geometric mean ratio 1.23, 95% confidence interval 1.12-1.36, p < 0.001) and first attempt success was less likely (odds ratio 0.64, 95% confidence interval 0.45-0.92, p = 0.016) with the SensaScope. Consultants showed a tendency for a better first attempt success compared to registrars. Overall, 23 intubations (10 Bonfils, 13 SensaScope) failed. Adverse events were rare and did not differ between devices.
CONCLUSIONS


A clear learning effect was demonstrated for both rigid scopes. Fourteen intubations with the Bonfils and 20 intubations with the SensaScope were required to reach a 90% first attempt success probability. Learning of the technique seemed more complex with the SensaScope compared to the Bonfils.
TRIAL REGISTRATION


Current Controlled Trials, ISRCTN14429285 . Registered 28 September 2011, retrospectively registered.",2020,"Intubation times were 23% longer (geometric mean ratio 1.23, 95% confidence interval 1.12-1.36, p < 0.001) and first attempt success was less likely (odds ratio 0.64, 95% confidence interval 0.45-0.92, p = 0.016) with the SensaScope.","['Fifteen consultant anaesthetists and 15 anaesthesia registrars performed a total of 740 intubations (10 to 20 intubations with each device per physician) in adult patients without predictors of a difficult airway under general anaesthesia', '740 intubations']",[],"['overall time to successful intubation', 'Intubation times', 'intubation success probability', 'Adverse events', 'first attempt success, first attempt success within 60\u2009s, failures and adverse events']","[{'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0557514', 'cui_str': 'Registrar'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",,0.176883,"Intubation times were 23% longer (geometric mean ratio 1.23, 95% confidence interval 1.12-1.36, p < 0.001) and first attempt success was less likely (odds ratio 0.64, 95% confidence interval 0.45-0.92, p = 0.016) with the SensaScope.","[{'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Theiler', 'Affiliation': 'Department of Anaesthesia, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Greif', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, 3010, Bern, Switzerland.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Bütikofer', 'Affiliation': 'CTU Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Kristopher', 'Initials': 'K', 'LastName': 'Arheart', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Kleine-Brueggeney', 'Affiliation': ""Department of Anaesthesia, University Children's Hospital Zurich - Eleonore Foundation and University of Zurich, Steinwiesstrasse 75, 8032, Zurich, Switzerland. maren.kleinebrueggeney@gmail.com.""}]",BMC anesthesiology,['10.1186/s12871-020-01181-w']
1186,33066746,Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trial.,"BACKGROUND


Knee Osteoarthritis (OA) is a leading cause of global disability. The Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals (CONNACT) Model of Care (MoC) was developed by optimizing evidence-based non-surgical treatments to deliver value-based care for people with knee OA. The primary aim of this study is to determine the clinical effectiveness of the CONNACT MoC (3 months) compared to usual care. The secondary aims are: a) To determine the cost-effectiveness and b) To develop an evaluation and implementation framework to inform large scale implementation for this MoC.
METHODOLOGY


Type 1 Effectiveness-Implementation Hybrid Trial using an explanatory sequential mixed-method approach. The study consists of 3 components. The first component is the pragmatic, parallel-arm, single-blinded randomized control trial. Inclusion criteria are patients with knee OA based on the National Institute of Health and Care Excellence (NICE) criteria with radiographic severity of greater than Kellgren-Lawrence 1, and Knee Injury and OA Outcome Score (KOOS 4 ) of equal or less than 75. Exclusion criteria include other forms of arthritis, history of previous knee arthroplasty or wheelchair-bound patient. KOOS 4  is the primary outcome measure at 3 months, 6 months and 1 year. Secondary outcomes include KOOS individual subscales, quality of life scoring, functional performance, global, diet and psychological related outcomes. The second component is an economic evaluation of the cost-effectiveness of the CONNACT MoC using a societal perspective. The third component is an implementation and evaluation framework using process evaluation under the RE-AIM framework using a mixed-method approach. Sample size of 100 patients has been calculated.
DISCUSSION


CONNACT MoC is a complex intervention. In line with the MRC guidance for developing and evaluating complex interventions, a pilot feasibility study was completed and a comprehensive approach including an RCT, economic evaluation and process evaluation is described in this study protocol. Results from this study will help clinicians, healthcare administrators and policymakers guide the sustainable and effective implementation of the CONNACT MoC for knee OA and serve as a basis for similar multidisciplinary MoC for chronic degenerative musculoskeletal conditions to be developed.
TRIAL REGISTRATION


Clinicaltrials.gov Identifier: NCT03809975 . Registered January 182,019.",2020,The Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals (CONNACT),"['Knee Osteoarthritis (OA', 'patients with knee OA based on the National Institute of Health and Care Excellence (NICE) criteria with radiographic severity of greater than Kellgren-Lawrence 1, and Knee Injury and OA Outcome Score (KOOS 4 ) of equal or less than 75', 'knee osteoarthritis (CONNACT', 'people with knee OA']","['CONNACT MoC', 'Allied Healthcare Professionals (CONNACT']","['KOOS individual subscales, quality of life scoring, functional performance, global, diet and psychological related outcomes']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0937334,The Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals (CONNACT),"[{'ForeName': 'Bryan Yijia', 'Initials': 'BY', 'LastName': 'Tan', 'Affiliation': 'Department of Orthopaedic Surgery, Woodlands Health Campus, National Healthcare Group, Singapore, Singapore. btanyj@hotmail.com.'}, {'ForeName': 'Michelle Jessica', 'Initials': 'MJ', 'LastName': 'Pereira', 'Affiliation': 'Health Services Outcome Research, National Healthcare Group, Singapore City, Singapore.'}, {'ForeName': 'Su-Yin', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopaedic Surgery, Woodlands Health Campus, National Healthcare Group, Singapore, Singapore.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute, University of Sydney and Rheumatology Department, Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'Soren Thorgaard', 'Initials': 'ST', 'LastName': 'Skou', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, Research Unit for Musculoskeletal Function and Physiotherapy, University of Southern Denmark, Odense M, Denmark.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Thumboo', 'Affiliation': 'Singapore General Hospital, Singapore City, Singapore.'}, {'ForeName': 'Josip', 'Initials': 'J', 'LastName': 'Car', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore City, Singapore.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03695-3']
1187,33066805,Improving adherence to an online intervention for low mood with a virtual coach: study protocol of a pilot randomized controlled trial.,"BACKGROUND


Internet-based cognitive-behavioral therapy (iCBT) is more effective when it is guided by human support than when it is unguided. This may be attributable to higher adherence rates that result from a positive effect of the accompanying support on motivation and on engagement with the intervention. This protocol presents the design of a pilot randomized controlled trial that aims to start bridging the gap between guided and unguided interventions. It will test an intervention that includes automated support delivered by an embodied conversational agent (ECA) in the form of a virtual coach.
METHODS/DESIGN


The study will employ a pilot two-armed randomized controlled trial design. The primary outcomes of the trial will be (1) the effectiveness of iCBT, as supported by a virtual coach, in terms of improved intervention adherence in comparison with unguided iCBT, and (2) the feasibility of a future, larger-scale trial in terms of recruitment, acceptability, and sample size calculation. Secondary aims will be to assess the virtual coach's effect on motivation, users' perceptions of the virtual coach, and general feasibility of the intervention as supported by a virtual coach. We will recruit N = 70 participants from the general population who wish to learn how they can improve their mood by using Moodbuster Lite, a 4-week cognitive-behavioral therapy course. Candidates with symptoms of moderate to severe depression will be excluded from study participation. Included participants will be randomized in a 1:1 ratio to either (1) Moodbuster Lite with automated support delivered by a virtual coach or (2) Moodbuster Lite without automated support. Assessments will be taken at baseline and post-study 4 weeks later.
DISCUSSION


The study will assess the preliminary effectiveness of a virtual coach in improving adherence and will determine the feasibility of a larger-scale RCT. It could represent a significant step in bridging the gap between guided and unguided iCBT interventions.
TRIAL REGISTRATION


Netherlands Trial Register (NTR) NL8110 . Registered on 23 October 2019.",2020,"It will test an intervention that includes automated support delivered by an embodied conversational agent (ECA) in the form of a virtual coach.
","['N\u2009=\u200970 participants from the general population who wish to learn how they can improve their mood by using Moodbuster Lite, a 4-week cognitive-behavioral therapy course']","['online intervention', 'Internet-based cognitive-behavioral therapy (iCBT', 'virtual coach', 'Moodbuster Lite with automated support delivered by a virtual coach or (2) Moodbuster Lite without automated support']","['effectiveness of iCBT, as supported by a virtual coach, in terms of improved intervention adherence in comparison with unguided iCBT, and (2) the feasibility of a future, larger-scale trial in terms of recruitment, acceptability, and sample size calculation']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}]",70.0,0.168878,"It will test an intervention that includes automated support delivered by an embodied conversational agent (ECA) in the form of a virtual coach.
","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Provoost', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Clinical Psychology Section, VU University and Amsterdam Public Health Research Institute, Amsterdam, Netherlands. s.j.provoost@vu.nl.'}, {'ForeName': 'Annet', 'Initials': 'A', 'LastName': 'Kleiboer', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Clinical Psychology Section, VU University and Amsterdam Public Health Research Institute, Amsterdam, Netherlands.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Ornelas', 'Affiliation': 'Institute for Systems and Computer Engineering, Technology and Science, Porto, Portugal.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Bosse', 'Affiliation': 'Behavioural Science Institute, Radboud University, Nijmegen, Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Ruwaard', 'Affiliation': 'Department of Psychiatry, Amsterdam UMC, Location VU University Medical Centre, and Amsterdam Public Health Research Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Rocha', 'Affiliation': 'Institute for Systems and Computer Engineering, Technology and Science, Porto, Portugal.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Clinical Psychology Section, VU University and Amsterdam Public Health Research Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Riper', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Clinical Psychology Section, VU University and Amsterdam Public Health Research Institute, Amsterdam, Netherlands.'}]",Trials,['10.1186/s13063-020-04777-2']
1188,33066811,"Therapeutic benefits of music-based synchronous finger tapping in Parkinson's disease-an fNIRS study protocol for randomized controlled trial in Dalian, China.","BACKGROUND


Music therapy improves neuronal activity and connectivity of healthy persons and patients with clinical symptoms of neurological diseases like Parkinson's disease, Alzheimer's disease, and major depression. Despite the plethora of publications that have reported the positive effects of music interventions, little is known about how music improves neuronal activity and connectivity in afflicted patients.
METHODS


For patients suffering from Parkinson's disease (PD), we propose a daily 25-min music-based synchronous finger tapping (SFT) intervention for 8 weeks. Eligible participants with PD are split into two groups: an intervention group and a control arm. In addition, a third cohort of healthy controls will be recruited. Assessment of finger tapping performances, the Unified Parkinson's Disease Rating Scale (UPDRS), an n-back test, the Montreal Cognitive Assessment (MoCA), as well as oxygenated hemoglobin (HbO 2 ), deoxygenated hemoglobin (HbR), and total hemoglobin activation collected by functional near-infrared spectroscopy (fNIRS) are measured at baseline, week 4 (during), week 8 (post), and week 12 (retention) of the study. Data collected from the two PD groups are compared to baseline performances from healthy controls.
DISCUSSION


This exploratory prospective trial study investigates the cortical neuronal activity and therapeutic effects associated with an auditory external cue used to induce automatic and implicit synchronous finger tapping in patients diagnosed with PD. The extent to which the intervention is effective may be dependent on the severity of the disease. The study's findings are used to inform larger clinical studies for optimization and further exploration of the therapeutic effects of movement-based music therapy on neural activity in neurological diseases.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04212897 . Registered on December 30, 2019. The participant recruitment and study protocol have received ethical approval from the First Affiliated Hospital of Dalian Medical University. The hospital Protocol Record number is PJ-KY-2019-123. The protocol was named ""fNIRS Studies of Music Intervention of Parkinson's Disease."" The current protocol is version 1.1, revised on September 1, 2020.",2020,"Assessment of finger tapping performances, the Unified Parkinson's Disease Rating Scale (UPDRS), an n-back test, the Montreal Cognitive Assessment (MoCA), as well as oxygenated hemoglobin (HbO 2 ), deoxygenated hemoglobin (HbR), and total hemoglobin activation collected by functional near-infrared spectroscopy (fNIRS) are measured at baseline, week 4 (during), week 8 (post), and week 12 (retention) of the study.","['Eligible participants with PD', ""healthy persons and patients with clinical symptoms of neurological diseases like Parkinson's disease, Alzheimer's disease, and major depression"", ""patients suffering from Parkinson's disease (PD"", ""Parkinson's disease-an fNIRS study protocol for randomized controlled trial in Dalian, China"", 'patients diagnosed with PD']","['auditory external cue used to induce automatic and implicit synchronous finger tapping', 'music-based synchronous finger tapping', 'Music therapy', 'daily 25-min music-based synchronous finger tapping (SFT) intervention']","['neuronal activity and connectivity', ""Assessment of finger tapping performances, the Unified Parkinson's Disease Rating Scale (UPDRS), an n-back test, the Montreal Cognitive Assessment (MoCA), as well as oxygenated hemoglobin (HbO 2 ), deoxygenated hemoglobin (HbR), and total hemoglobin activation collected by functional near-infrared spectroscopy (fNIRS""]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}]",,0.0567397,"Assessment of finger tapping performances, the Unified Parkinson's Disease Rating Scale (UPDRS), an n-back test, the Montreal Cognitive Assessment (MoCA), as well as oxygenated hemoglobin (HbO 2 ), deoxygenated hemoglobin (HbR), and total hemoglobin activation collected by functional near-infrared spectroscopy (fNIRS) are measured at baseline, week 4 (during), week 8 (post), and week 12 (retention) of the study.","[{'ForeName': 'Lanlan', 'Initials': 'L', 'LastName': 'Pu', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, China.'}, {'ForeName': 'Nauman Khalid', 'Initials': 'NK', 'LastName': 'Qureshi', 'Affiliation': 'School of Biomedical Engineering, Faculty of Electronic Information and Electrical Engineering, Dalian University of Technology, Dalian, Liaoning Province, China.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Ly', 'Affiliation': 'Department of Biomedical Engineering, University of California, Irvine, CA, USA.'}, {'ForeName': 'Bingwei', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, China.'}, {'ForeName': 'Fengyu', 'Initials': 'F', 'LastName': 'Cong', 'Affiliation': 'School of Biomedical Engineering, Faculty of Electronic Information and Electrical Engineering, Dalian University of Technology, Dalian, Liaoning Province, China.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Tang', 'Affiliation': 'Department of Biomedical Engineering, University of California, Irvine, CA, USA. wctang@uci.edu.'}, {'ForeName': 'Zhanhua', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, China. zhanhualiang@163.com.'}]",Trials,['10.1186/s13063-020-04770-9']
1189,33066812,A blended eHealth intervention for insomnia following acquired brain injury: study protocol for a randomized controlled trial.,"BACKGROUND


Up to a third of stroke patients and patients with traumatic brain injury suffer from insomnia, including problems to fall asleep or stay asleep at night. Insomnia may exacerbate other brain damage-related problems, for example regarding cognitive functioning and emotional well-being; may lead to poorer quality of life; and may complicate recovery processes. Cognitive behavioral therapy for insomnia, delivered face-to-face or online, is found to be effective in the general population. However, despite the high prevalence and serious consequences of insomnia following acquired brain injury, studies on the efficacy of face-to-face cognitive behavioral treatment in this population are scarce, and this applies even more for studies on online cognitive behavioral therapy. Therefore, this study aims to evaluate the efficacy of a newly developed guided online cognitive behavioral therapy for insomnia following acquired brain injury.
METHODS


A multicenter, prospective, randomized, open-label, blinded end point study (PROBE) will be conducted, in which 48 patients diagnosed with stroke or traumatic brain injury and insomnia will be randomly allocated to the online cognitive behavioral therapy for insomnia treatment group or the treatment as usual group. The treatment consists of 6 online cognitive behavioral therapy sessions given on a weekly basis and personalized feedback after each session, combined with 2 face-to-face sessions. Outcomes will be assessed at baseline, immediately after the intervention period and at 6-week follow-up. The primary outcome is the insomnia severity assessed with the Insomnia Severity Index. Secondary outcome measures include sleep quality, sleep features derived from the sleep diary, fatigue, anxiety and depression, subjective cognitive functioning, and societal participation.
DISCUSSION


This study will provide insight on the efficacy of online cognitive behavioral therapy for insomnia following stroke and traumatic brain injury.
TRIAL REGISTRATION


Netherlands Trial Register NTR7082 . Registered on 12 March 2018.",2020,"Cognitive behavioral therapy for insomnia, delivered face-to-face or online, is found to be effective in the general population.","['stroke patients and patients with traumatic brain injury suffer from insomnia, including problems to fall asleep or stay asleep at night', '48 patients diagnosed with stroke or traumatic brain injury and insomnia']","['guided online cognitive behavioral therapy', 'blended eHealth intervention', 'online cognitive behavioral therapy for insomnia treatment group or the treatment as usual group', 'Cognitive behavioral therapy', 'online cognitive behavioral therapy']","['insomnia severity assessed with the Insomnia Severity Index', 'sleep quality, sleep features derived from the sleep diary, fatigue, anxiety and depression, subjective cognitive functioning, and societal participation']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",48.0,0.0795238,"Cognitive behavioral therapy for insomnia, delivered face-to-face or online, is found to be effective in the general population.","[{'ForeName': 'Marthe E', 'Initials': 'ME', 'LastName': 'Ford', 'Affiliation': 'Department of Psychology, Heliomare Rehabilitation, Wijk aan Zee, The Netherlands. m.e.ford@vu.nl.'}, {'ForeName': 'Gert J', 'Initials': 'GJ', 'LastName': 'Geurtsen', 'Affiliation': 'Department of Medical Psychology, Amsterdam UMC, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Erny', 'Initials': 'E', 'LastName': 'Groet', 'Affiliation': 'Department of Psychology, Heliomare Rehabilitation, Wijk aan Zee, The Netherlands.'}, {'ForeName': 'Coen A M', 'Initials': 'CAM', 'LastName': 'Van Bennekom', 'Affiliation': 'Department of Medical Psychology, Amsterdam UMC, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Eus J W', 'Initials': 'EJW', 'LastName': 'Van Someren', 'Affiliation': 'Department of Sleep and Cognition, Netherlands Institute for Neuroscience, Amsterdam, The Netherlands.'}]",Trials,['10.1186/s13063-020-04789-y']
1190,33066856,Effect of Turmacin supplementation on joint discomfort and functional outcome among healthy participants - A randomized placebo-controlled trial.,"OBJECTIVE


Curcuma longa has been widely used in Ayurveda for its medicinal properties and Turmacin was developed from C. longa as a standardized extract containing turmerosaccharides. In this clinical trial, the effect of Turmacin on knee joint discomfort in healthy adults subjected to strenuous physical activity was evaluated.
DESIGN


Double-blind, triple-arm, parallel-group, randomized placebo-controlled trial.
SETTING


Healthy participants from an urban tertiary care teaching hospital.
INTERVENTION


Healthy participants were randomized in 1:1:1 ratio to receive either Turmacin 0.5 g/1 g or placebo once daily for 84 days. The participants were subjected to 10-minute strenuous exercise.
OUTCOME MEASURES


Time to initial pain, final pain score on a visual analogue scale, range of movement (ROM) of knee and the force of contractions of muscles around the knee joint.
RESULTS


A total of n = 90 participants were recruited. The mean final pain scores were significantly lower in the Turmacin 1 g and Turmacin 0.5 g when compared with the placebo from day-7 and day-5 onwards respectively. The survival analysis consistently showed a decreased hazard for early onset of pain in both the Turmacin groups. On day-84, the difference in mean ROM between Turmacin 0.5 g and placebo was 4.79 degrees (p = 0.008) and that for Turmacin 1 g and placebo was 2.34 degrees (p = 0.306). The difference in muscle force for isokinetic contractions of the quadriceps at angular velocities of 120 and 180 was significant between Turmacin 0.5 g and placebo (p = 0.002 and p = 0.005 respectively) while that for Turmacin 1 g & Turmacin 0.5 g (p = 0.206 and p = 0.414 respectively) and Turmacin 1 g & Placebo (p = 0.046 and p = 0.037) were not significant. However, in the within group analysis participants in Turmacin 1 g group had better preserved muscle functions than Turmacin 0.5 g group at angular velocities of 120 and 180 when compared with placebo.
CONCLUSION


Turmacin (0.5 g and 1 g) was efficacious when compared to placebo in increasing the pain threshold and knee ROM in healthy participants with minor adverse events.",2020,The mean final pain scores were significantly lower in the Turmacin 1 g and Turmacin 0.5 g when compared with the placebo from day-7 and day-5 onwards respectively.,"['healthy adults', 'healthy participants with minor adverse events', 'A total of n\u2009=\u200990 participants were recruited', 'Healthy participants from an urban tertiary care teaching hospital', 'healthy participants - A randomized', 'Healthy participants']","['10-minute strenuous exercise', 'Turmacin supplementation', 'Turmacin', 'placebo', 'Placebo', 'Turmacin 0.5\u2009g/1\u2009g or placebo']","['muscle functions', 'muscle force for isokinetic contractions of the quadriceps at angular velocities', 'Time to initial pain, final pain score on a visual analogue scale, range of movement (ROM) of knee and the force of contractions of muscles around the knee joint', 'joint discomfort and functional outcome', 'mean final pain scores', 'pain threshold and knee ROM', 'mean ROM', 'knee joint discomfort']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}]",90.0,0.572943,The mean final pain scores were significantly lower in the Turmacin 1 g and Turmacin 0.5 g when compared with the placebo from day-7 and day-5 onwards respectively.,"[{'ForeName': 'Jeffrey Pradeep', 'Initials': 'JP', 'LastName': 'Raj', 'Affiliation': ""Department of Clinical Pharmacology, St. John's Medical College, Bangalore 560 034, India. Electronic address: jpraj.m07@gmail.com.""}, {'ForeName': 'Shreeraam', 'Initials': 'S', 'LastName': 'Venkatachalam', 'Affiliation': ""Department of Orthopaedics, St. John's Medical College, Bangalore 560 034, India.""}, {'ForeName': 'Pranathi', 'Initials': 'P', 'LastName': 'Racha', 'Affiliation': ""Department of Physiology, St. John's Medical College, Bangalore 560 034, India.""}, {'ForeName': 'Sreejith', 'Initials': 'S', 'LastName': 'Bhaskaran', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, Bangalore 560 034, India.""}, {'ForeName': 'Rajkumar S', 'Initials': 'RS', 'LastName': 'Amaravati', 'Affiliation': ""Department of Orthopaedics, St. John's Medical College, Bangalore 560 034, India.""}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102522']
1191,32697145,Re: Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 mL): 6-Month Results from the WATER II Trial.,,2020,,['Benign Prostatic Hyperplasia in Large Prostates (80-150 mL'],[],[],"[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0426732', 'cui_str': 'Large prostate'}, {'cui': 'C4321486', 'cui_str': '150'}]",[],[],,0.0279485,,"[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001205']
1192,32698260,Effects of leucine-enriched essential amino acid supplementation on muscular fatigue and inflammatory cytokines in wheelchair basketball players.,"PURPOSE


This study aimed to investigate the effects of leucine-enriched essential amino acid (LEAA) supplementation on muscle fatigue and the level of inflammatory cytokines in wheelchair basketball players after a basketball game and interval training.
METHODS


Of the ten recruited wheelchair basketball players (aged 34.5±8.9 years; lean body mass of 34.3±10.0 kg) who had spinal cord injury (SCI) and had undergone amputation, nine participated in the final test. These nine athletes received LEAA supplements (3 times 4.0 g/day) or placebo treatment in a double-blind, randomized, crossover study. We measured variables related to muscular fatigue and inflammatory response before the intense exercise and 4 days after recovery.
RESULTS


The significant effect of LEAA supplementation was inhibition of circulating IL-6 levels in the LEAA-treated group compared with the placebo group (P < .05). However, no changes were observed in the TNF-α and creatinine kinase levels. Moreover, analysis of variance analysis showed no significant difference in the relative values of muscle soreness. However, the effect size analysis with Cohen's d reported a significant improvement in the relative values of whole body and back muscle soreness.
CONCLUSION


Our results revealed that LEAA supplementation before and after intense exercise could help reduce muscle soreness and IL-6 levels in wheelchair basketball players.",2020,Our results revealed that LEAA supplementation before and after intense exercise could help reduce muscle soreness and IL-6 levels in wheelchair basketball players.,"['wheelchair basketball players', 'wheelchair basketball players after a basketball game and interval training', 'Of the ten recruited wheelchair basketball players (aged 34.5±8.9 years; lean body mass of 34.3±10.0 kg) who had spinal cord injury (SCI) and had undergone amputation, nine participated in the final test']","['LEAA supplements', 'leucine-enriched essential amino acid supplementation', 'LEAA', 'leucine-enriched essential amino acid (LEAA) supplementation', 'placebo']","['muscular fatigue and inflammatory cytokines', 'muscle soreness and IL-6 levels', 'muscle fatigue and the level of inflammatory cytokines', 'relative values of muscle soreness', 'relative values of whole body and back muscle soreness', 'circulating IL-6 levels', 'TNF-α and creatinine kinase levels', 'muscular fatigue and inflammatory response']","[{'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0556083', 'cui_str': 'Essential amino acid supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205345', 'cui_str': 'Relative'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0224334', 'cui_str': 'Skeletal muscle structure of back'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}]",10.0,0.524042,Our results revealed that LEAA supplementation before and after intense exercise could help reduce muscle soreness and IL-6 levels in wheelchair basketball players.,"[{'ForeName': 'Young Hwan', 'Initials': 'YH', 'LastName': 'An', 'Affiliation': ''}, {'ForeName': 'Jisu', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hee-Jae', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Kiwon', 'Initials': 'K', 'LastName': 'Lim', 'Affiliation': ''}]",Physical activity and nutrition,['10.20463/pan.2020.0013']
1193,33068425,Hydroxychloroquine as pre-exposure prophylaxis for COVID-19 in healthcare workers: a randomized trial.,"BACKGROUND


Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging virus causing the ongoing Covid-19 pandemic with no known effective prophylaxis. We investigated whether hydroxychloroquine could prevent SARS-CoV-2 in healthcare workers at high risk of exposure.
METHODS


We conducted a randomized, double-blind, placebo-controlled clinical trial of healthcare workers with ongoing exposure to persons with SARS-CoV-2, including those working in emergency departments, intensive care units, Covid-19 hospital wards, and first responders. Participants across the United States and in the Canadian province of Manitoba were randomized to hydroxychloroquine 400mg once weekly or twice weekly for 12 weeks. The primary endpoint was confirmed or probable Covid-19-compatible illness. We measured hydroxychloroquine whole blood concentrations.
RESULTS


We enrolled 1483 healthcare workers, of which 79% reported performing aerosol-generating procedures. The incidence of Covid-19 (laboratory-confirmed or symptomatic compatible illness) was 0.27 events per person-year with once-weekly and 0.28 events per person-year with twice-weekly hydroxychloroquine compared with 0.38 events per person-year with placebo. For once weekly hydroxychloroquine prophylaxis, the hazard ratio was 0.72 (95%CI 0.44 to 1.16; P=0.18), and for twice-weekly was 0.74 (95%CI 0.46 to 1.19; P=0.22) as compared with placebo. Median hydroxychloroquine concentrations in whole blood were 98 ng/mL (IQR, 82-120) with once-weekly and 200 ng/mL (IQR, 159-258) with twice-weekly dosing. Hydroxychloroquine concentrations did not differ between participants who developed Covid-19-compatible illness (154 ng/mL) versus participants without Covid-19 (133 ng/mL; P=0.08).
CONCLUSIONS


Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed Covid-19 or Covid-19-compatible illness among healthcare workers.",2020,Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed Covid-19 or Covid-19-compatible illness among healthcare workers.,"['healthcare workers', 'healthcare workers at high risk of exposure', 'Participants across the United States and in the Canadian province of Manitoba', 'We enrolled 1483 healthcare workers, of which 79% reported performing aerosol-generating procedures', 'healthcare workers with ongoing exposure to persons with SARS-CoV-2, including those working in emergency departments, intensive care units, Covid-19 hospital wards, and first responders']","['placebo', 'hydroxychloroquine', 'Hydroxychloroquine']","['Covid-19-compatible illness', 'probable Covid-19-compatible illness', 'Hydroxychloroquine concentrations', 'Median hydroxychloroquine concentrations', 'incidence of Covid-19 (laboratory-confirmed or symptomatic compatible illness']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0024726', 'cui_str': 'Manitoba'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C3178988', 'cui_str': 'Emergency First Responders'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",1483.0,0.743112,Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed Covid-19 or Covid-19-compatible illness among healthcare workers.,"[{'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Axelrod', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Darlisha A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'Section of Infectious Diseases, Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Balko', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Dunlop', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Katherine H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1571']
1194,33068444,"Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomised, controlled trial.","BACKGROUND


Secukinumab has demonstrated sustained long-term efficacy with a favourable safety profile in various psoriatic disease manifestations in adults.
OBJECTIVES


Here, the efficacy and safety of two secukinumab dosing regimens (low dose [LD] and high dose [HD]) in paediatric patients with severe chronic plaque psoriasis over one year are reported.
METHODS


In this multicentre, double-blind study (NCT02471144), patients aged 6 to <18 years with severe chronic plaque psoriasis were stratified and randomised by weight (<25 kg, 25 to <50 kg, ≥50 kg) and age (6 to <12 years, 12 to <18 years) to receive low-dose (LD: 75/75/150 mg) or high-dose (HD: 75/150/300 mg) subcutaneous secukinumab or placebo or etanercept 0.8 mg/kg (up to a max of 50 mg).
RESULTS


Overall, 162 patients were randomised to receive secukinumab LD (n=40) or HD (n=40), etanercept (n=41) or placebo (n=41). The co-primary objectives of the study were met with both secukinumab doses (LD and HD) showing superior efficacy compared to placebo (P < 0.0001) with respect to PASI 75 response (80.0%, 77.5% vs. 14.6%) and IGA mod 2011, 0 or 1 response (70%, 60% vs. 4.9%) at Week 12. Both secukinumab doses were superior to placebo (P < 0.0001) with respect to PASI 90 response at Week 12 (72.5%, 67.5% vs 2.4%). The efficacy of both doses was sustained to Week 52 with secukinumab achieving higher responses vs. etanercept (PASI 75/90/100: LD, 87.5%/75.0%/40.0% and HD, 87.5%/80.0%/47.5.% vs. etanercept, 68.3%/51.2%/22.0% and IGA 0 or 1: LD, 72.5% and HD, 75.0% vs. etanercept, 56.1%). The safety profile of secukinumab was consistent with the adult Phase 3 studies, with no new safety signals identified.
CONCLUSIONS


Both doses of secukinumab demonstrated high and sustained efficacy up to Week 52 with a favourable safety profile in paediatric patients with severe chronic plaque psoriasis.",2020,Both doses of secukinumab demonstrated high and sustained efficacy up to Week 52 with a favourable safety profile in paediatric patients with severe chronic plaque psoriasis.,"['patients aged 6 to <18 years with severe chronic plaque psoriasis were stratified and randomised by weight (<25 kg, 25 to <50 kg, ≥50 kg) and age (6 to <12 years, 12 to <18 years) to', 'paediatric patients with severe chronic plaque psoriasis', 'various psoriatic disease manifestations in adults', 'paediatric patients with severe chronic plaque psoriasis over one year are reported', '162 patients']","['etanercept', 'secukinumab dosing regimens (low dose [LD] and high dose [HD', 'secukinumab', 'secukinumab LD', 'placebo', 'Secukinumab', 'receive low-dose (LD: 75/75/150 mg) or high-dose (HD: 75/150/300 mg) subcutaneous secukinumab or placebo or etanercept', 'HD']",['efficacy and safety'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C5191360', 'cui_str': '162'}]","[{'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",162.0,0.48739,Both doses of secukinumab demonstrated high and sustained efficacy up to Week 52 with a favourable safety profile in paediatric patients with severe chronic plaque psoriasis.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bodemer', 'Affiliation': 'Department of Dermatology, Paris centre university, Hôpital Necker-Enfants Malades, APHP Paris, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kaszuba', 'Affiliation': 'DERMED Medical Services, Lodz, Poland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kingo', 'Affiliation': 'Tartu University Hospital and University of Tartu, Tartu, Estonia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tsianakas', 'Affiliation': 'Fachklinik Bad Bentheim, Bad Bentheim, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Morita', 'Affiliation': 'Nagoya City University Hospital, Nagoya city, Aichi, Japan.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rivas', 'Affiliation': 'Dermos, Guatemala City, Guatemala.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Papanastasiou', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Keefe', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Patekar', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Charef', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cafoncelli', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Papavassilis', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.17002']
1195,33068445,Different injection patterns of incobotulinumtoxinA for crow's feet: a split-face comparative study.,"BACKGROUND


IncobotulinumtoxinA has been previously used for the treatment of lateral periorbital lines (crow's feet). However, a standardized injection technique has not been established.
OBJECTIVES


To compare the efficacy and effect duration of two injection techniques of incobotulinumtoxinA for crow's feet treatment.
METHODS


Forty-eight patients with crow's feet were recruited and randomly assigned to receive bilateral treatments using either a 3-point intramuscular or a 6-point intradermal injection technique (8-12 units of incobotulinumtoxinA on each side). Improvement was assessed at 1, 2, 4, 8, 12, 16, 20, and 24 weeks postinjection. An objective evaluation was assessed by the indentation index using a 3D camera and a subjective evaluation was assessed by a blinded dermatologist using the Flynn validated assessment scale for the upper face (FVAS). The patients assessed the results using the Global Aesthetic Improvement Scale (GAIS). Side effects were evaluated at each visit.
RESULTS


After treatment, a significantly greater reduction in the indentation index of periorbital wrinkles on the 3-point intramuscular injection side compared to the 6-point intradermal injection side was observed at 8, 12, and 16 weeks. The results from the FVAS and GAIS scores showed significantly longer median times to relapse of the periorbital wrinkle for the 3-point intramuscular injection compared to the 6-point intradermal injection. Pain and bruising were slightly greater with the 6-point intradermal technique.
CONCLUSIONS


This study reaffirmed the efficacy of incobotulinumtoxinA for the treatment of crow's feet. The 3-point intramuscular injection technique yielded greater efficacy and longer duration of action than the 6-point intradermal injection technique.",2020,The 3-point intramuscular injection technique yielded greater efficacy and longer duration of action than the 6-point intradermal injection technique.,"[""Forty-eight patients with crow's feet"", ""crow's feet""]","['3-point intramuscular or a 6-point intradermal injection technique', 'incobotulinumtoxinA']","['Pain and bruising', 'indentation index of periorbital wrinkles', 'Side effects', 'FVAS and GAIS scores', 'efficacy and longer duration of action', 'Global Aesthetic Improvement Scale (GAIS']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0277939', 'cui_str': ""Crow's feet""}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332467', 'cui_str': 'Indentation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0230064', 'cui_str': 'Periorbital'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0441472', 'cui_str': 'Action'}]",48.0,0.0175267,The 3-point intramuscular injection technique yielded greater efficacy and longer duration of action than the 6-point intradermal injection technique.,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Vachiramon', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Subpayasarn', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Triyangkulsri', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Jurairattanaporn', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rattananukrom', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16997']
1196,33068631,"Recovery of reward function in problematic substance users using a combination of robotics, electrophysiology, and TMS.","BACKGROUND


Theoretical and empirical work suggest that addictive drugs potentiate dopaminergic reinforcement learning signals and disrupt the reward function of its neural targets, including the anterior midcingulate cortex (aMCC) and the basal ganglia. Here, we aim to use prefrontal 10-Hz TMS to enhance aMCC reward activity and reward learning by the basal ganglia in problematic substance users.
METHODS


22 problematic substance users were randomized into an Active and SHAM (coil flipped) TMS group. We recorded the reward positivity-an electrophysiological signal believed to index sensitivity of the aMCC to rewards-while participants engaged in 4 blocks (100 trials per block) of a reward-based choice task. A robotic arm positioned a TMS coil over a prefrontal cortex target, and 50 pulses were delivered at 10-Hz before every 10 trials of blocks 2-4 (1500 pulses, 400 trials). Participants then completed a decision-making task that is diagnostic of striatal dopamine dysfunction.
RESULTS


The present study revealed three main findings. First, both groups failed to elicit a reward positivity during the first two task blocks. Second, applying robot-assisted TMS enhanced the amplitude of the reward positivity in the Active group, but not the SHAM group, across the last two task blocks. Third, the Active group performed relatively better at reward-based learning than the SHAM group.
CONCLUSION


These results demonstrate that 10-Hz TMS is successful in modulating the reward function of the aMCC and basal ganglia in problematic substance users, which may have utility in the treatment of reward-related neural dysfunction commonly associated with substance use disorders.",2020,"Second, applying robot-assisted TMS enhanced the amplitude of the reward positivity in the Active group, but not the SHAM group, across the last two task blocks.","['22 problematic substance users', 'problematic substance users']","['10-Hz', 'TMS', 'robotics, electrophysiology, and TMS', 'Active and SHAM (coil flipped', 'robot-assisted TMS', 'prefrontal 10-Hz TMS']",['amplitude of the reward positivity'],"[{'cui': 'C0338666', 'cui_str': 'Misuses drugs'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0013865', 'cui_str': 'Electrophysiology'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}]",,0.128632,"Second, applying robot-assisted TMS enhanced the amplitude of the reward positivity in the Active group, but not the SHAM group, across the last two task blocks.","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Biernacki', 'Affiliation': 'Center for Molecular and Behavioral Neuroscience, Rutgers University-Newark, Newark, NJ 07102, United States of America.'}, {'ForeName': 'Mei-Heng', 'Initials': 'MH', 'LastName': 'Lin', 'Affiliation': 'Center for Molecular and Behavioral Neuroscience, Rutgers University-Newark, Newark, NJ 07102, United States of America.'}, {'ForeName': 'Travis E', 'Initials': 'TE', 'LastName': 'Baker', 'Affiliation': 'Center for Molecular and Behavioral Neuroscience, Rutgers University-Newark, Newark, NJ 07102, United States of America. Electronic address: travis.e.baker@rutgers.edu.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.08.008']
1197,33068667,"Mindfulness, Mood, and Food: The Mediating Role of Positive Affect.","With rates of overweight and obesity rising worldwide, it is important to examine psychological factors associated with food intake. Previous research has shown that mindfulness may serve as a protective factor against overconsumption of food. Some studies have posited that mindfulness addresses unhealthy eating by promoting the increased awareness of, and decreased responsiveness to, internal emotional cues. The present study investigated the effects of a brief mindfulness induction on positive and negative affect and subsequent energy intake in a sample of undergraduate students (N = 126). After exposure to a negative mood induction, 63 participants were randomly assigned to a brief mindfulness intervention, while the remaining participants listened to a news article. Subsequently all participants were offered healthful and unhealthful snack foods. Although there was not a significant between-group difference in intake, a multiple mediation model indicated that positive affect, but not negative affect, significantly mediated the association between condition and food intake. Relative to controls, those in the experimental condition reported higher positive affect after the mindfulness induction, which in turn reduced their energy intake. Further exploratory analyses indicated that positive affect in the experimental group was associated with reduced consumption of unhealthful food. These findings provide insight into how mindfulness-based interventions may target unhealthy eating behaviors.",2020,"Although there was not a significant between-group difference in intake, a multiple mediation model indicated that positive affect, but not negative affect, significantly mediated the association between condition and food intake.","['63 participants', 'a sample of undergraduate students (N = 126']","['brief mindfulness intervention, while the remaining participants listened to a news article']","['positive and negative affect and subsequent energy intake', 'Mindfulness, Mood, and Food']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0470256', 'cui_str': '126'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0282425', 'cui_str': 'News'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",63.0,0.0206694,"Although there was not a significant between-group difference in intake, a multiple mediation model indicated that positive affect, but not negative affect, significantly mediated the association between condition and food intake.","[{'ForeName': 'Ti', 'Initials': 'T', 'LastName': 'Hsu', 'Affiliation': 'Department of Psychological Sciences, William & Mary, P.O. Box 8795, Williamsburg, VA, 23187-8795, U.S.A.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Forestell', 'Affiliation': 'Department of Psychological Sciences, William & Mary, P.O. Box 8795, Williamsburg, VA, 23187-8795, U.S.A. Electronic address: caforestell@wm.edu.'}]",Appetite,['10.1016/j.appet.2020.105001']
1198,33068770,Benefits of using a simulator in the initial training for transvaginal ultrasound examination in gynecologic emergency unit.,"PURPOSE


Transvaginal ultrasound examination is decisive in Gynecologic emergency unit. This study's aim was to evaluate benefits of using a simulator for initial training of medical student for transvaginal ultrasound examination.
METHOD


A multicenter randomized trial was conducted. Medical student were randomized in two groups: in the intervention group, students took part in a simulation session in addition to the companionship-training while in the control group, they were only trained by companionship. To evaluate their progression, the quality of ultrasound pictures performed in real conditions before (pre-test) and after (post-test) the training by the students of both groups were evaluated and compared. Evaluation was performed according to predefined quality criterias for each ultrasound examination using a score of 20 points. Mean scores of students in both groups were compared for the pre and post-test.
RESULTS


Fifty six medical students were included. Mean scores of the 56 students were significantly better at the post-test than at the pre-test: 10,61/20 [9,62-11, 59] vs 6,35/20 [5,48-7,24], p < 0,001. Mean scores were significantly better at the post-test for students in the intervention group (n = 29) than in the control group (n = 27) 11,79/20 [7,72-10,94] vs 9,33/20 [7,72-10,94], p = 0,01. All the students in the intervention group were satisfied or highly satisfied to take part in this program.
CONCLUSIONS


Using a simulator for medical student was beneficial in the initial training of transvaginal ultrasound examination.",2020,"Mean scores were significantly better at the post-test for students in the intervention group (n = 29) than in the control group (n = 27) 11,79/20","['Gynecologic emergency unit', 'six medical students were included', 'Fifty', 'gynecologic emergency unit']","['students took part in a simulation session in addition to the companionship-training while in the control group, they were only trained by companionship', 'Transvaginal ultrasound examination']",['Mean scores'],"[{'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",56.0,0.0271445,"Mean scores were significantly better at the post-test for students in the intervention group (n = 29) than in the control group (n = 27) 11,79/20","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Etienne', 'Affiliation': 'Department of obstetrics and gynecology, Hôpital Bicêtre, GHU Sud, AP-HP, F-94276, Le Kremlin Bicêtre, France; Faculty of medicine, Univ Paris Sud, F-94276, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Gabay', 'Affiliation': 'Department of obstetrics and gynecology, Hôpital Bicêtre, GHU Sud, AP-HP, F-94276, Le Kremlin Bicêtre, France; Faculty of medicine, Univ Paris Sud, F-94276, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Levaillant', 'Initials': 'L', 'LastName': 'Jean-Marc', 'Affiliation': 'Department of obstetrics and gynecology, Hôpital Bicêtre, GHU Sud, AP-HP, F-94276, Le Kremlin Bicêtre, France; Faculty of medicine, Univ Paris Sud, F-94276, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Vivanti', 'Initials': 'V', 'LastName': 'Alexandre', 'Affiliation': 'Department of obstetrics and gynecology, Hôpital Pitié-Salpêtrière, AP-HP, 75013, Paris, France; Faculty of medicine, Univ Paris Sud, F-94276, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Dommergues', 'Initials': 'D', 'LastName': 'Marc', 'Affiliation': 'Department of obstetrics and gynecology, Hopital Antoine Bécère, GHU Sud, AP-HP, 92140, Clamart, France; Faculty of medicine, Univ Paris Sud, F-94276, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Fernandez', 'Initials': 'F', 'LastName': 'Hervé', 'Affiliation': 'Department of obstetrics and gynecology, Hôpital Bicêtre, GHU Sud, AP-HP, F-94276, Le Kremlin Bicêtre, France; Department of obstetrics and gynecology, Hopital Antoine Bécère, GHU Sud, AP-HP, 92140, Clamart, France; Inserm, Centre of research in Epidemiology and population health (CESP), U1018, F-94276, Le Kremlin Bicêtre, France; Faculty of medicine, Univ Paris Sud, F-94276, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Capmas', 'Initials': 'C', 'LastName': 'Perrine', 'Affiliation': 'Department of obstetrics and gynecology, Hôpital Bicêtre, GHU Sud, AP-HP, F-94276, Le Kremlin Bicêtre, France; Department of obstetrics and gynecology, Hopital Antoine Bécère, GHU Sud, AP-HP, 92140, Clamart, France; Inserm, Centre of research in Epidemiology and population health (CESP), U1018, F-94276, Le Kremlin Bicêtre, France; Faculty of medicine, Univ Paris Sud, F-94276, Le Kremlin Bicêtre, France. Electronic address: perrine.capmas@aphp.fr.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101938']
1199,33068792,Impact of Treating Physician on Radiotherapy Related Severe Toxicities in Men with Prostate Cancer.,"BACKGROUND


The impact of treating physician on radiotherapy-related toxicity is unclear. We carried out a secondary analysis of a randomized controlled study to determine if the risk of radiotherapy-related late toxicities in prostate cancer (PCa) patients varies depending on the treating radiation oncologist.
PATIENTS AND METHODS


This is a secondary analysis of a phase III randomized controlled study in which PCa patients with Gleason score ≤7, clinical stage T1b-T3a and prostate-specific antigen <30 ng/mL were randomized to receive androgen suppression for 6 months starting either 4 months before or concurrently with definitive prostate radiotherapy. Incidence of late radiotherapy-related toxicity was estimated using Kaplan-Meier methods. We applied multivariable semiparametric shared frailty models with gamma distribution to determine the between-physician variation in the hazard of late radiotherapy-related grade ≥3 gastrointestinal, genitourinary, or overall toxicity. Patient level covariables included age, risk group, year of enrollment and treatment regimen. Frailty variance, a measure of unexplained heterogeneity, was estimated with 95% confidence intervals (CI). Statistical significance was suggested when the lower limit of the 95% CI for the frailty variance was > 0. Commenges-Andersen test was used for p-value estimation.
RESULTS


Overall, 426 patients were treated by 9 radiation oncologists. On log-rank test, there was a significant difference in the cumulative incidence of overall grade ≥3 toxicities (p=0.001) and grade ≥3 gastrointestinal (p=0.01) among the physician-based clusters. The frailty variance for overall late grade ≥3 toxicity was 0.31 (95% CI: 0.02-1.39)(p=0.01). The frailty variance for the grade ≥3 gastrointestinal and genitourinary toxicity was 0.84 (95% CI: 0.00-4.20)(p=0.11) and 0.11 (95% CI: 0.00-1.13)(p=0.31), respectively.
CONCLUSIONS


In our study, the hazard of overall radiotherapy-related late grade ≥3 toxicity varied significantly depending on treating radiation oncologist. Further studies are required to explore the underlying processes that lead to such variations in clinical trials involving radiotherapy in prostate cancer.",2020,The frailty variance for the grade ≥3 gastrointestinal and genitourinary toxicity was 0.84,"['prostate cancer (PCa) patients', 'Men with Prostate Cancer', 'PCa patients with Gleason score ≤7, clinical stage T1b-T3a and prostate-specific', '426 patients were treated by 9 radiation oncologists']","['androgen suppression', 'definitive prostate radiotherapy', 'radiotherapy', 'Radiotherapy']","['grade ≥3 gastrointestinal', 'grade ≥3 gastrointestinal and genitourinary toxicity', 'hazard of overall radiotherapy-related late grade ≥3 toxicity', 'Incidence of late radiotherapy-related toxicity', 'cumulative incidence of overall grade ≥3 toxicities', 'Frailty variance', 'frailty variance for overall late grade ≥3 toxicity']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332326', 'cui_str': 'Gleason grading system for prostatic cancer'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0475385', 'cui_str': 'Tumor stage T1b'}, {'cui': 'C0475390', 'cui_str': 'Tumor stage T3a'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1514693', 'cui_str': 'Radiation oncologist'}]","[{'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0948317', 'cui_str': 'Radiotherapy to prostate'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}]",426.0,0.201391,The frailty variance for the grade ≥3 gastrointestinal and genitourinary toxicity was 0.84,"[{'ForeName': 'Soumyajit', 'Initials': 'S', 'LastName': 'Roy', 'Affiliation': 'New York Medical College, New York, NY, USA; The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada; Division of Radiation Oncology, Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Grimes', 'Affiliation': 'The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Morgan', 'Affiliation': 'The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada; Division of Radiation Oncology, Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Spratt', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Libni', 'Initials': 'L', 'LastName': 'Eapen', 'Affiliation': 'The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada; Division of Radiation Oncology, Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Mac Rae', 'Affiliation': 'The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada; Division of Radiation Oncology, Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Malone', 'Affiliation': 'The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Craig', 'Affiliation': 'The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Malone', 'Affiliation': 'The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada; Division of Radiation Oncology, Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada. Electronic address: smalone@toh.ca.'}]",Practical radiation oncology,['10.1016/j.prro.2020.09.013']
1200,33068819,In vitro effect of antimicrobial photodynamic therapy with phycocyanin on Aggregatibacter actinomycetemcomitans biofilm on SLA titanium discs.,"BACKGROUND AND PURPOSE


The aim of this in vitro study was to evaluate the antimicrobial photodynamic therapy (aPDT) with phycocyanin on Aggregatibacter actinomycetemcomitans biofilm formed on sandblasted, large-grit, and acid-etched (SLA) titanium discs.
MATERIALS AND METHODS


In this in vitro experimental study, the minimum inhibitory concentration (MIC), sublethal dose of diode laser irradiation time, and sublethal dose of aPDT were first determined. Next, 30 SLA titanium discs with 8 mm diameter and 2 mm thickness were incubated with A. actinomycetemcomitans in order for the bacterial biofilm to form, and were randomly divided into 5 groups (n = 6): (I) negative control with no treatment, (II) positive control, immersed in 0.2% chlorhexidine (CHX) for 5 min, (III) phycocyanin alone with ×2 MIC concentration for 5 min, (IV) diode laser alone (635 nm wavelength, 220 mW power), and (V) PDT with diode laser and phycocyanin. The samples were then sonicated, and the number of colony-forming units (CFUs) on each disc was calculated. Data were analyzed using one-way ANOVA, t-test, and a post-hoc test.
RESULTS


aPDT with 125 μg/mL phycocyanin and 4 min irradiation of 635 nm diode laser decreasedA. actinomycetemcomitans biofilm by 40.07%. The lowest mean colony count (CFUs/mL) was noted in 0.2% CHX group (0.0 × 10 5  CFU/mL) while the highest mean was observed in the negative control group (4.55 ± 0.08 × 10 5  CFUs/mL). Using phycocyanin alone significantly decreased the A. actinomycetemcomitans count by 27.54% (3.29 ± 0.6 × 10 5  CFUs/mL) compared with the negative control group (P < 0.0001). Significant differences were noted between the negative control and other groups (P < 0.0001).
CONCLUSION


aPDT with phycocyanin and diode laser can decrease the A. actinomycetemcomitans biofilm on SLA titanium implant surfaces and can be used as a safe and non-invasive decontamination method for reduction of A. actinomycetemcomitans biofilm on implant surfaces.",2020,Using phycocyanin alone significantly decreased the A. actinomycetemcomitans count by 27.54% (3.29 ± 0.6 × 10 5  CFUs/mL) compared with the negative control group (P < 0.0001).,[],"['phycocyanin alone with ×2 MIC concentration for 5\u2009min, (IV) diode laser alone', 'PDT with diode laser and phycocyanin', 'antimicrobial photodynamic therapy with phycocyanin', 'phycocyanin', 'CHX', 'antimicrobial photodynamic therapy (aPDT) with phycocyanin', 'negative control with no treatment, (II) positive control, immersed in 0.2% chlorhexidine (CHX', 'phycocyanin and diode laser']","['lowest mean colony count (CFUs/mL', 'minimum inhibitory concentration (MIC), sublethal dose of diode laser irradiation time, and sublethal dose of aPDT', 'A. actinomycetemcomitans count']",[],"[{'cui': 'C0031788', 'cui_str': 'Phycocyanin'}, {'cui': 'C0427978', 'cui_str': 'MIC'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0368993', 'cui_str': 'Colony count'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2945590', 'cui_str': 'U/mL'}, {'cui': 'C0427978', 'cui_str': 'MIC'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",,0.0211032,Using phycocyanin alone significantly decreased the A. actinomycetemcomitans count by 27.54% (3.29 ± 0.6 × 10 5  CFUs/mL) compared with the negative control group (P < 0.0001).,"[{'ForeName': 'Ardavan', 'Initials': 'A', 'LastName': 'Etemadi', 'Affiliation': 'Department of Periodontics, Faculty of Dentistry, Tehran Medical Sciences, Islamic Azad University, Laser Research Center of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Eftfkhari Bayati', 'Affiliation': 'Dental Student, Faculty of Dentistry, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Pourhajibagher', 'Affiliation': 'Dental Research Center, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Chiniforoush', 'Affiliation': 'Dental Implant Research Center, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: n-chiniforush@sina.tums.ac.ir.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.102062']
1201,33068901,"Facilitating Activity and Self-management for people with Arthritic knee, hip or lower back pain (FASA): A cluster randomised controlled trial.","BACKGROUND


Chronic musculoskeletal pain including osteoarthritis (OA) can significantly limit the functional independence of individuals. The spine and hip and knee are predominantly affected; management guidelines for each recommend exercise and education to support self-management.
OBJECTIVES


This study investigated the effectiveness of a generic exercise and self-management intervention for people over-50 with hip/knee OA and/or lower back pain compared to continued GP management.
DESIGN


Single blind, cluster randomised controlled trial.
METHOD


Participants who had previously consulted with hip/knee OA and/or chronic lower back pain were recruited from 45 GP practices in SW England. Practices were randomly allocated to receive continued GP care (control) or continued GP care and a 6-week group exercise and self-management intervention facilitated by a physiotherapist and located in a community-based physiotherapy department. The primary outcome measure was the Dysfunction Index of the Short Musculoskeletal Functional Assessment (DI-SMFA) measured at six month post-rehabilitation.
RESULTS


349 participants were recruited and allocated to the intervention (n = 170) or control (n = 179) arms; the attrition rate was 13% at the 6 month primary end-point. One minor adverse event in the intervention group that required no medical input was reported. Intervention arm participants reported better function at 6 months compared with continued GP management alone (-3.01 difference in DI-SMFA [95%CI -5.25, -0.76], p = 0.01).
CONCLUSIONS


A generic exercise and self-management intervention resulted in statistically significant changes in function after six-months compared with GP management alone, but clinical significance of these findings is less clear. This may be an effective way of managing group interventions for lower limb OA and chronic lower back pain.",2020,"A generic exercise and self-management intervention resulted in statistically significant changes in function after six-months compared with GP management alone, but clinical significance of these findings is less clear.","['people with Arthritic knee, hip or lower back pain (FASA', 'people over-50 with hip/knee OA and/or lower back pain', '349 participants', 'Participants who had previously consulted with hip/knee OA and/or chronic lower back pain were recruited from 45\xa0GP practices in SW England', 'Chronic musculoskeletal pain including osteoarthritis (OA']","['generic exercise and self-management intervention', 'continued GP care (control) or continued GP care and a 6-week group exercise and self-management intervention facilitated by a physiotherapist and located in a community-based physiotherapy department', 'continued GP management alone']","['Dysfunction Index of the Short Musculoskeletal Functional Assessment (DI-SMFA', 'attrition rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0587975', 'cui_str': 'Physiotherapy department'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",349.0,0.105192,"A generic exercise and self-management intervention resulted in statistically significant changes in function after six-months compared with GP management alone, but clinical significance of these findings is less clear.","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Walsh', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK. Electronic address: Nicola.walsh@uwe.ac.uk.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Phillips', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': ""Lang'o"", 'Initials': 'L', 'LastName': 'Odondi', 'Affiliation': 'Division of Cardiovascular Medicine, University of Nottingham, UK.'}, {'ForeName': 'Shea', 'Initials': 'S', 'LastName': 'Palmer', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Cramp', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Pollock', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Hurley', 'Affiliation': ""Faculty for Health, Social Care and Education. St George's University of London & Kingston University, UK.""}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102271']
1202,33069163,Mid-pregnancy weight gain is associated with offspring adiposity outcomes in early childhood.,"BACKGROUND


Gestational weight gain (GWG) has been linked to childhood obesity. However, it is unclear if the timing of weight gain influences offspring body composition. A secondary analysis of a clinical trial examined the influence of total, early, and mid-pregnancy GWG on adiposity outcomes in 186 children at birth, 1, 3, and 5 years.
METHODS


Early (<15 weeks) and mid-pregnancy GWG (15-32 weeks) were assessed. Anthropometrics and abdominal ultrasound were measured annually in children from birth to 5 years. MRI was performed in a sub-group of 44 children at 5 years to estimate abdominal fat.
RESULTS


Almost half of the women (n = 86/186) gained excess weight in pregnancy, and women with a BMI ≥ 25 kg/m 2  (n = 33) were more likely to gain in excess. Mid-pregnancy GWG predicted higher weight (g) and subcutaneous fat (mm 2 ) by ultrasound and MRI (cm 3 ) at 5 years [β: 139.34 g (95% CI: -0.22; 278.90), p = 0.050; β: 1.42 mm 2  (95% CI: 0.06; 2.78), p = 0.041; and β: 18.56 cm 3  (95% CI: 1.30; 35.82) p = 0.036, respectively].
CONCLUSIONS


Mid-pregnancy weight gain was associated with greater fat depots at 5 years, which suggests that the timing of GWG has differential effects on offspring adiposity outcomes.
IMPACT


What is the key message of this article? Gestational weight gained in mid-pregnancy is associated with growth and adipose tissue development at 5 years. What does it add to existing literature? We observed that maternal weight gain in early and mid-gestation has differential effects on offspring body composition.Mid-pregnancy weight gain (15-32 weeks gestation) appears to influence child growth and abdominal fat accretion which may have implications for long-term metabolic health. What is its impact? Interventions that prevent excessive gestational weight gain in mid-pregnancy may affect obesity risk in early childhood.Prenatal care should stress the importance of optimal weight gain throughout pregnancy.",2020,pregnancy GWG predicted higher weight (g) and subcutaneous fat (mm 2 ) by ultrasound and MRI (cm 3 ) at 5 years [β:,"['Early (<15 weeks) and mid-pregnancy GWG (15-32 weeks', '186 children at birth, 1, 3, and 5 years', '25', 'children from birth to 5 years']",[],"['Anthropometrics and abdominal ultrasound', 'gain in excess. Mid', 'excessive gestational weight gain', 'weight (g) and subcutaneous fat', 'Gestational weight', 'maternal weight gain']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",[],"[{'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}]",186.0,0.0947749,pregnancy GWG predicted higher weight (g) and subcutaneous fat (mm 2 ) by ultrasound and MRI (cm 3 ) at 5 years [β:,"[{'ForeName': 'Dorothy Marie', 'Initials': 'DM', 'LastName': 'Meyer', 'Affiliation': 'Else Kröner-Fresenius-Centre for Nutritional Medicine, School of Medicine, Klinikum rechts der Isar, Technical University of Munich, Georg-Brauchle-Ring 62, 80992, Munich, Germany.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Stecher', 'Affiliation': 'Else Kröner-Fresenius-Centre for Nutritional Medicine, School of Medicine, Klinikum rechts der Isar, Technical University of Munich, Georg-Brauchle-Ring 62, 80992, Munich, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Brei', 'Affiliation': 'Else Kröner-Fresenius-Centre for Nutritional Medicine, School of Medicine, Klinikum rechts der Isar, Technical University of Munich, Georg-Brauchle-Ring 62, 80992, Munich, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Hauner', 'Affiliation': 'Else Kröner-Fresenius-Centre for Nutritional Medicine, School of Medicine, Klinikum rechts der Isar, Technical University of Munich, Georg-Brauchle-Ring 62, 80992, Munich, Germany. hans.hauner@tum.de.'}]",Pediatric research,['10.1038/s41390-020-01202-x']
1203,33069172,Intensive versus guideline-recommended blood pressure reduction in acute lacunar stroke with intravenous thrombolysis therapy: the ENCHANTED trial.,"BACKGROUND


Investigation of differential effects of early intensive versus guideline-recommended blood pressure (BP) lowering between lacunar and non-lacunar acute ischemic stroke (AIS) in the BP arm of Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED).
METHODS


In 1632 participants classified as having definite or probable lacunar (n=454 [27.8%]) or non-lacunar AIS according to pre-specified definitions based upon clinical and adjudicated imaging findings, mean BP changes over Days 0 to 7 were plotted, and systolic BP differences by treatment between subgroups estimated in generalized linear models. Logistic regression models were used to estimate the BP treatment effects on 90-day outcomes (primary, an ordinal shift of modified Rankin scale [mRS] scores) across lacunar and non-lacunar AIS after adjustment for baseline covariables.
RESULTS


Most baseline characteristics, acute BP and other management, differed between lacunar and non-lacunar AIS, but mean systolic BP difference by treatment were comparable at each time point (all P interaction  >0.12) and over 24 hours post-randomization (-5.5 [95% CI -6.5, -4.4] mmHg in lacunar AIS vs. -5.6 [95% CI -6.3, -4.8] mmHg in non-lacunar AIS, P interaction  =0.93). The neutral effect of intensive BP lowering on functional outcome and beneficial effect on intracranial hemorrhage were similar for the two subgroups (all P interaction  >0.19).
CONCLUSIONS


There were no differences in the treatment effect of early intensive versus guideline-recommended BP lowering across lacunar and non-lacunar AIS.",2020,There were no differences in the treatment effect of early intensive versus guideline-recommended BP lowering across lacunar and non-lacunar AIS.,"['1632 participants classified as having definite or probable lacunar (n=454 [27.8%]) or non-lacunar AIS', 'acute lacunar stroke with intravenous thrombolysis therapy']","['Intensive versus guideline-recommended blood pressure reduction', 'early intensive versus guideline-recommended blood pressure (BP) lowering between lacunar']","['ordinal shift of modified Rankin scale [mRS] scores) across lacunar and non-lacunar AIS', 'mean systolic BP difference', 'intracranial hemorrhage']","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C3178801', 'cui_str': 'Lacunar stroke'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]","[{'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}]",1632.0,0.0837521,There were no differences in the treatment effect of early intensive versus guideline-recommended BP lowering across lacunar and non-lacunar AIS.,"[{'ForeName': 'Zien', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xia', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Carcel', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Sohei', 'Initials': 'S', 'LastName': 'Yoshimura', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Delcourt', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Malavera', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Mair', 'Affiliation': 'Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences, University of Edinburgh, UK, Edinburgh.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Demchuk', 'Affiliation': 'Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'The George Institute for Global Health and University of Sydney, Sydney, Australia.'}, {'ForeName': 'Thompson G', 'Initials': 'TG', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center, University of Leicester, Leicester, UK.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'South Western Clinical School, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Wardlaw', 'Affiliation': 'Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences, University of Edinburgh, UK, Edinburgh.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}]",European journal of neurology,['10.1111/ene.14598']
1204,30137250,"Human Immunodeficiency Virus Type 1 and Tuberculosis Coinfection in Multinational, Resource-limited Settings: Increased Neurological Dysfunction.","BACKGROUND


AIDS Clinical Trial Group 5199 compared neurological and neuropsychological test performance of human immunodeficiency virus type 1 (HIV-1)-infected participants in resource-limited settings treated with 3 World Health Organization-recommended antiretroviral (ART) regimens. We investigated the impact of tuberculosis (TB) on neurological and neuropsychological outcomes.
METHODS


Standardized neurological and neuropsychological examinations were administered every 24 weeks. Generalized estimating equation models assessed the association between TB and neurological/neuropsychological performance.
RESULTS


Characteristics of the 860 participants at baseline were as follows: 53% female, 49% African; median age, 34 years; CD4 count, 173 cells/μL; and plasma HIV-1 RNA, 5.0 log copies/mL. At baseline, there were 36 cases of pulmonary, 9 cases of extrapulmonary, and 1 case of central nervous system (CNS) TB. Over the 192 weeks of follow-up, there were 55 observations of pulmonary TB in 52 persons, 26 observations of extrapulmonary TB in 25 persons, and 3 observations of CNS TB in 2 persons. Prevalence of TB decreased with ART initiation and follow-up. Those with TB coinfection had significantly poorer performance on grooved pegboard (P < .001) and fingertapping nondominant hand (P < .01). TB was associated with diffuse CNS disease (P < .05). Furthermore, those with TB had 9.27 times (P < .001) higher odds of reporting decreased quality of life, and had 8.02 times (P = .0005) higher odds of loss of productivity.
CONCLUSIONS


TB coinfection was associated with poorer neuropsychological functioning, particularly the fine motor skills, and had a substantial impact on functional ability and quality of life.
CLINICAL TRIALS REGISTRATION


NCT00096824.",2019,Those with TB coinfection had significantly poorer performance on grooved pegboard (P < .001) and fingertapping nondominant hand (P < .01).,"['860 participants at baseline were as follows: 53% female, 49% African; median age, 34 years; CD4 count, 173 cells/μL; and plasma HIV-1 RNA, 5.0 log copies/mL', 'human immunodeficiency virus type 1 (HIV-1)-infected participants in resource-limited settings treated with 3 World Health Organization-recommended antiretroviral (ART) regimens', 'Human Immunodeficiency Virus Type 1 and Tuberculosis Coinfection in Multinational, Resource-limited Settings']",[],"['Prevalence of TB', 'quality of life', 'Neurological Dysfunction', 'central nervous system (CNS) TB', 'functional ability and quality of life']","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}]",[],"[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",,0.404807,Those with TB coinfection had significantly poorer performance on grooved pegboard (P < .001) and fingertapping nondominant hand (P < .01).,"[{'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Robertson', 'Affiliation': 'AIDS Neurological Center, Neurology, University of North Carolina, Chapel Hill.'}, {'ForeName': 'Bibilola', 'Initials': 'B', 'LastName': 'Oladeji', 'Affiliation': 'University of Ibadan, Nigeria.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Johnstone', 'Initials': 'J', 'LastName': 'Kumwenda', 'Affiliation': 'Queen Elizabeth, Blantyre, Malawi.'}, {'ForeName': 'Khuanchai', 'Initials': 'K', 'LastName': 'Supparatpinyo', 'Affiliation': 'Chiang Mai University, Thailand.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Campbell', 'Affiliation': 'University of Colorado Health Sciences Center, Denver.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hakim', 'Affiliation': 'University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Tripathy', 'Affiliation': 'National AIDS Research Institute, Pune, India.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'Lilongwe, Malawi.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Marra', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Nagalingeswaran', 'Initials': 'N', 'LastName': 'Kumarasamy', 'Affiliation': 'Gaitonde Centre for AIDS Research and Education, Chennai, India.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Evans', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Vecchio', 'Affiliation': 'Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'La Rosa', 'Affiliation': 'Asociacion Civil Impacta Salud y Educacion,Lima, Peru.'}, {'ForeName': 'Breno', 'Initials': 'B', 'LastName': 'Santos', 'Affiliation': 'Hospital Conceicao, Porto Alegre Porto Alegre.'}, {'ForeName': 'Marcus T', 'Initials': 'MT', 'LastName': 'Silva', 'Affiliation': 'Fiocruz, Rio De Janeiro, Brazil.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Montano', 'Affiliation': 'Asociacion Civil Impacta Salud y Educacion,Lima, Peru.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Kanyama', 'Affiliation': 'Lilongwe, Malawi.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Firnhaber', 'Affiliation': 'Johannesburg, South Africa.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Price', 'Affiliation': 'University of California San Francisco.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Marcus', 'Affiliation': 'AIDS Neurological Center, Neurology, University of North Carolina, Chapel Hill.'}, {'ForeName': 'Baida', 'Initials': 'B', 'LastName': 'Berzins', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Masih', 'Affiliation': 'Social Scientific Systems, Silver Springs, Maryland.'}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Lalloo', 'Affiliation': 'Durban, South Africa.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Sanne', 'Affiliation': 'Johannesburg, South Africa.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Yosief', 'Affiliation': 'AIDS Neurological Center, Neurology, University of North Carolina, Chapel Hill.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Walawander', 'Affiliation': 'Frontier Science & Technology Research Foundation, Buffalo, New York.'}, {'ForeName': 'Aspara', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'Frontier Science & Technology Research Foundation, Buffalo, New York.'}, {'ForeName': 'Ned', 'Initials': 'N', 'LastName': 'Sacktor', 'Affiliation': 'Johns Hopkins University, Baltimore.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Hall', 'Affiliation': 'AIDS Neurological Center, Neurology, University of North Carolina, Chapel Hill.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy718']
1205,32703634,A Randomised Controlled Trial Assessing the Effects of Peri-operative Fenofibrate Administration on Abdominal Aortic Aneurysm Pathology: Outcomes From the FAME Trial.,"OBJECTIVE


Experimental studies suggest that fenofibrate prevents abdominal aortic aneurysm (AAA) development by lowering aortic osteopontin (OPN) concentration and reducing the number of macrophages infiltrating the aortic wall. The current study examined the effects of a short course of fenofibrate on AAA pathology in people with large AAAs awaiting aortic repair.
METHODS


This randomised double blind parallel trial included male and female participants aged ≥ 60 years who had an asymptomatic AAA measuring ≥ 50 mm and were scheduled to undergo open AAA repair. Participants were allocated to fenofibrate (145 mg/day) or matching placebo for at least two weeks before elective AAA repair. Blood samples were collected at recruitment and immediately prior to surgery. AAA biopsies were obtained during aortic surgery. The primary outcomes were (1) AAA OPN concentration; (2) serum OPN concentration; and (3) number of AAA macrophages. Exploratory outcomes included circulating and aortic concentrations of other proteins previously associated with AAA. Outcomes assessed at a single time point were compared using logistic regression. Longitudinal outcomes were compared using linear mixed effects models.
RESULTS


Forty-three participants were randomised. After three withdrawals, 40 were followed until the time of surgery (21 allocated fenofibrate and 19 allocated placebo). As expected, serum triglycerides reduced significantly from recruitment to the time of surgery in participants allocated fenofibrate. No differences in any of the primary and exploratory outcomes were observed between groups.
CONCLUSION


A short course of 145 mg of fenofibrate/day did not lower concentrations of OPN or aortic macrophage density in people with large AAAs.",2020,A short course of 145 mg of fenofibrate/day did not lower concentrations of OPN or aortic macrophage density in people with large AAAs.,"['Forty-three participants were randomised', 'people with large AAAs', 'male and female participants aged ≥ 60 years who had an asymptomatic AAA measuring ≥ 50\xa0mm and were scheduled to undergo open AAA repair', 'people with large AAAs awaiting aortic repair', 'Abdominal Aortic Aneurysm Pathology']","['fenofibrate and 19 allocated placebo', 'fenofibrate', 'Peri-operative Fenofibrate Administration', 'matching placebo']","['serum triglycerides', 'Blood samples', 'AAA OPN concentration; (2) serum OPN concentration; and (3) number of AAA macrophages', 'concentrations of OPN or aortic macrophage density', 'circulating and aortic concentrations of other proteins previously associated with AAA']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0271742', 'cui_str': 'Glucocorticoid deficiency with achalasia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0450400', 'cui_str': '50mm'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0741152', 'cui_str': 'Repair of aneurysm of abdominal aorta'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0069676', 'cui_str': 'Osteopontin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",43.0,0.5654,A short course of 145 mg of fenofibrate/day did not lower concentrations of OPN or aortic macrophage density in people with large AAAs.,"[{'ForeName': 'Joseph V', 'Initials': 'JV', 'LastName': 'Moxon', 'Affiliation': 'The Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia; Centre for Molecular Therapeutics, The Australian Institute of Tropical Health and Medicine, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': 'Rowbotham', 'Affiliation': ""The University of Queensland, UQ Centre for Clinical Research, Herston, Queensland, Australia; Department of Vascular Surgery, The Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.""}, {'ForeName': 'Jenna L', 'Initials': 'JL', 'LastName': 'Pinchbeck', 'Affiliation': 'The Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Lazzaroni', 'Affiliation': 'The Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Susan K', 'Initials': 'SK', 'LastName': 'Morton', 'Affiliation': 'The Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Corey S', 'Initials': 'CS', 'LastName': 'Moran', 'Affiliation': 'The Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Quigley', 'Affiliation': 'Mater Medical Centre, Pimlico, Queensland, Australia.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Jenkins', 'Affiliation': ""Department of Vascular Surgery, The Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.""}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia; School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Cavaye', 'Affiliation': ""St Vincent's Private Hospital Northside, Chermside, Queensland, Australia.""}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Jaeggi', 'Affiliation': 'The Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Golledge', 'Affiliation': 'The Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia; Centre for Molecular Therapeutics, The Australian Institute of Tropical Health and Medicine, James Cook University, Townsville, Queensland, Australia; Department of Vascular and Endovascular Surgery, Townsville University Hospital, Townsville, Queensland, Australia. Electronic address: jonathan.golledge@jcu.edu.au.'}]",European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery,['10.1016/j.ejvs.2020.06.006']
1206,32701826,Body Composition Changes in Response to Moderate- or High-Intensity Exercise Among Older Adults With or Without HIV Infection.,"BACKGROUND


People with HIV (PWH) are at an increased risk for adiposity and sarcopenia, despite effective antiretroviral therapy. Our objective was to compare the effects of prescribed exercise on body composition in older PWH and uninfected controls.
SETTING


Academic medical center.
METHODS


Sedentary PWH (n = 27) and uninfected controls (n = 28) aged 50-75 years completed 24 weeks of cardiovascular and resistance exercise. Participants completed 12 weeks of moderate-intensity exercise and then were randomized to moderate- or high-intensity exercise for 12 additional weeks. Total lean (LEAN) and fat mass (FAT), and visceral adipose tissue area (VAT) were measured using dual-energy x-ray absorptiometry at baseline and 24 weeks; baseline and intervention differences were compared by HIV serostatus using multivariable regression analyses adjusted for baseline values, age, and exercise adherence.
RESULTS


At baseline, PWH had significantly lower FAT (P = 0.003), but no significant differences in LEAN or VAT compared with controls (P > 0.20). Changes over 24 weeks were not significantly different by HIV serostatus, although controls tended to gain more LEAN (0.8 kg; range, 0-1.6 kg; P = 0.04] than PWH (0.6 kg; range, -0.2 to 1.4 kg; P = 0.12) and lose less FAT and VAT (controls: (-0.9 kg; range, -1.8 to 0.0 kg and -10.3 cm; range, -19.6, 1.0) cm; both P = 0.03 vs PWH: -2.0 kg; range, -2.9 to -1.1 kg and -17.7 cm; range, -27.1 to -8.2 cm; both P < 0.001). Exercise intensity differences were not apparent for LEAN, FAT, or VAT.
CONCLUSIONS


Exercise reduced total and visceral fat in older PWH and controls. Minimal gains in lean mass suggest that greater emphasis on resistance exercise may be needed to more effectively increase muscle in PWH.",2020,"At baseline, PWH had significantly lower FAT (P=0.003), but no significant differences in LEAN or VAT compared to controls (P>0.20).","['Participants completed 12 weeks of moderate-intensity exercise', 'People with HIV (PWH', 'Academic medical center METHODS:: Sedentary PWH (n=27) and uninfected controls (n=28) aged 50-75 completed 24 weeks of', 'Older Adults with or without HIV Infection', 'older PWH and uninfected controls']","['moderate- or high-intensity exercise', 'Exercise', 'cardiovascular and resistance exercise']","['Total lean (LEAN) and fat mass (FAT) and visceral adipose tissue area (VAT', 'LEAN or VAT', 'FAT and VAT', 'FAT', 'total and visceral fat']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0042427', 'cui_str': 'Vatican City'}]",,0.152703,"At baseline, PWH had significantly lower FAT (P=0.003), but no significant differences in LEAN or VAT compared to controls (P>0.20).","[{'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Jankowski', 'Affiliation': 'University of Colorado College of Nursing, Aurora, CO.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Mawhinney', 'Affiliation': 'Department of Biostatistics, University of Colorado Anschutz Medical Campus, School of Public Health, Aurora, CO.'}, {'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'Wilson', 'Affiliation': 'Department of Biostatistics, University of Colorado Anschutz Medical Campus, School of Public Health, Aurora, CO.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Kohrt', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Schwartz', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Todd T', 'Initials': 'TT', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Diabetes, & Metabolism, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Kristine M', 'Initials': 'KM', 'LastName': 'Erlandson', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Colorado Anschutz Medical Campus, Aurora, CO.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002443']
1207,32692358,A Randomized Controlled Trial of Long-Term (R)-α-Lipoic Acid Supplementation Promotes Weight Loss in Overweight or Obese Adults without Altering Baseline Elevated Plasma Triglyceride Concentrations.,"BACKGROUND


α-Lipoic acid (LA) is a dietary supplement for maintaining energy balance, but well-controlled clinical trials in otherwise healthy, overweight adults using LA supplementation are lacking.
OBJECTIVES


The primary objective was to evaluate whether LA supplementation decreases elevated plasma triglycerides in overweight or obese adults. Secondary aims examined if LA promotes weight loss and improves oxidative stress and inflammation.
METHODS


Overweight adults [n = 81; 57% women; 21-60 y old; BMI (in kg/m2) ≥ 25] with elevated plasma triglycerides ≥100 mg/dL were enrolled in a 24-wk, randomized, double-blind, controlled trial, assigned to either (R)-α-lipoic acid (R-LA; 600 mg/d) or matching placebo, and advised not to change their diet or physical activity. Linear models were used to evaluate treatment effects from baseline for primary and secondary endpoints.
RESULTS


R-LA did not decrease triglyceride concentrations, but individuals on R-LA had a greater reduction in BMI at 24 wk than the placebo group (-0.8; P = 0.04). The effect of R-LA on BMI was correlated to changes in plasma triglycerides (r = +0.50, P = 0.004). Improvement in body weight was greater at 24 wk in R-LA subgroups than in placebo subgroups. Women and obese participants (BMI ≥ 35) showed greater weight loss (-5.0% and -4.8%, respectively; both P < 0.001) and loss of body fat (-9.4% and -8.6%, respectively; both P < 0.005). Antioxidant gene expression in mononuclear cells at 24 wk was greater in the R-LA group (Heme oxygenase 1 [HMOX1] : +22%; P = 0.02) than in placebo. Less urinary F2-isoprostanes (-25%; P = 0.005), blood leukocytes (-10.1%; P = 0.01), blood thrombocytes (-5.1%; P = 0.03), and ICAM-1 (-7.4%; P = 0.04) at 24 wk were also observed in the R-LA group than in placebo.
CONCLUSIONS


Long-term LA supplementation results in BMI loss, greater antioxidant enzyme synthesis, and less potential for inflammation in overweight adults. Improved cellular bioenergetics is also evident in some individuals given R-LA.This trial was registered at clinicaltrials.gov as NCT00765310.",2020,"Less urinary F2-isoprostanes (-25%; P = 0.005), blood leukocytes (-10.1%; P = 0.01), blood thrombocytes (-5.1%; P = 0.03), and ICAM-1 (-7.4%; P = 0.04) at 24 wk were also observed in the R-LA group than in placebo.
","['overweight adults', 'overweight or obese adults', 'Overweight or Obese Adults without Altering Baseline Elevated Plasma Triglyceride Concentrations', 'Overweight adults [n\xa0=\xa081; 57% women; 21-60 y old; BMI (in kg/m2)\xa0≥\xa025] with elevated plasma triglycerides ≥100']","['Long-term LA supplementation', 'α-Lipoic acid (LA', 'R-LA', 'Long-Term (R)-α-Lipoic Acid Supplementation', 'R)-α-lipoic acid (R-LA; 600\xa0mg/d) or matching placebo', 'LA supplementation', 'LA', 'placebo']","['Antioxidant gene expression in mononuclear cells', 'triglyceride concentrations', 'Weight Loss', 'oxidative stress and inflammation', 'body weight', 'Less urinary F2-isoprostanes', 'BMI', 'weight loss', 'blood leukocytes', 'blood thrombocytes', 'ICAM-1', 'loss of body fat', 'cellular bioenergetics', 'plasma triglycerides', 'BMI loss, greater antioxidant enzyme synthesis']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0949861', 'cui_str': 'F2-Isoprostane'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0023516', 'cui_str': 'Leukocyte'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0424630', 'cui_str': 'Loss of body fat - finding'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0005486', 'cui_str': 'Bioenergetics'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",,0.697621,"Less urinary F2-isoprostanes (-25%; P = 0.005), blood leukocytes (-10.1%; P = 0.01), blood thrombocytes (-5.1%; P = 0.03), and ICAM-1 (-7.4%; P = 0.04) at 24 wk were also observed in the R-LA group than in placebo.
","[{'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Bobe', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Michels', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Wei-Jian', 'Initials': 'WJ', 'LastName': 'Zhang', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Jonathan Q', 'Initials': 'JQ', 'LastName': 'Purnell', 'Affiliation': 'Department of Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Woffendin', 'Affiliation': 'Oregon Clinical and Translational Research Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Cliff', 'Initials': 'C', 'LastName': 'Pereira', 'Affiliation': 'Department of Statistics, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Vita', 'Affiliation': 'Evans Department of Medicine and the Whitaker Cardiovascular Institute, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Nicholas O', 'Initials': 'NO', 'LastName': 'Thomas', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Maret G', 'Initials': 'MG', 'LastName': 'Traber', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Balz', 'Initials': 'B', 'LastName': 'Frei', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Tory M', 'Initials': 'TM', 'LastName': 'Hagen', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa203']
1208,32693116,Topical therapy with rhubarb navel plasters in patients with chronic constipation: Results from a prospective randomized multicenter study.,"ETHNOPHARMACOLOGICAL RELEVANCE


Constipation is a functional gastrointestinal disorder and one of the most prevalent conditions encountered in primary care settings. Rhubarb navel dressings have been used for more than 2,000 years in Chinese medicine to treat constipation. However, the effect of topical rhubarb administration has still not been well recognized and this strategy is not yet established as an evidence-based approach.
AIM OF THE STUDY


In this study, we performed a prospective multicentric randomized controlled trial to evaluate the efficacy and safety of rhubarb navel plasters for patients with chronic constipation.
MATERIALS AND METHODS


A total of 374 patients from six teaching hospitals were prospectively included between 09/2016 and 10/2017 in the study based on Rome III criteria. All participants were randomly assigned (1:1) into verum/placebo group and given either Rheum officinale rhubarb powder or a placebo flour stick on the navel for 6 h/day/8 days. Primary outcome measures were the Cleveland Constipation Score (CCS) for the feces condition and Bristol Stool Scale (BSS) for stool consistency and 24 h defecation frequency.
RESULTS


The groups demonstrated no statistical differences in demographic data, clinical diagnoses and concomitant medication at baseline. In patients treated with the verum CCS was 5.61 (day 8, 95% CI 5.15-6.07) compared to 8.62 (95% CI 8.07-9.18) in placebo-treated controls (P < 0.001). The mean change of CCS at the end of treatment (day 8 versus [vs] day 0) was 6.04 in verum-treated vs 2.73 in placebo-treated controls (P < 0.001). Also 24 h defecation frequency (BSS) showed superior results (day 5: 0.84 vs 0.62, 95% CI 0.67-0.80, P < 0.001; day 6: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01 and day 8: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01) and better BSS type classification during treatment than controls (P < 0.05). No significant differences in adverse events between both groups became obvious.
CONCLUSION


Rhubarb navel plaster administration over an 8-day-treatment period resulted in significantly improved bowel function as demonstrated by the CCS, 24 h defecating frequency and BSS. Our results suggest that rhubarb navel plasters represent a feasible, safe and efficient application route for the treatment of patients suffering from chronic constipation.",2020,"Also 24 h defecation frequency (BSS) showed superior results (day 5: 0.84 vs 0.62, 95% CI 0.67-0.80, P < 0.001; day 6: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01 and day 8: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01) and better BSS type classification during treatment than controls (P < 0.05).","['patients with chronic constipation', 'patients suffering from chronic constipation', '374 patients from six teaching hospitals were prospectively included between 09/2016 and 10/2017 in the study based on Rome III criteria']","['verum/placebo group and given either Rheum officinale rhubarb powder or a placebo flour stick', 'Rhubarb navel dressings', 'Topical therapy', 'rhubarb navel plasters', 'verum CCS']","['demographic data, clinical diagnoses and concomitant medication', 'bowel function', 'BSS type classification', 'efficacy and safety', 'adverse events', 'defecation frequency (BSS', 'Cleveland Constipation Score (CCS) for the feces condition and Bristol Stool Scale (BSS) for stool consistency and 24\u202fh defecation frequency', 'mean change of CCS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0035509', 'cui_str': 'Rhubarb'}, {'cui': 'C1815861', 'cui_str': 'Rhubarb powder'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C1706582', 'cui_str': 'Stick'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0460977', 'cui_str': 'Plasters'}, {'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0457570', 'cui_str': 'Scale type'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",374.0,0.207116,"Also 24 h defecation frequency (BSS) showed superior results (day 5: 0.84 vs 0.62, 95% CI 0.67-0.80, P < 0.001; day 6: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01 and day 8: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01) and better BSS type classification during treatment than controls (P < 0.05).","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: weilin22@126.com.'}, {'ForeName': 'Yueming', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'The fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China. Electronic address: 314851488@qq.com.'}, {'ForeName': 'Xiaopei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: xingyunxing021@163.com.'}, {'ForeName': 'Yangchen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: morning924@126.com.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gasser', 'Affiliation': 'University of Wuerzburg, Wuerzburg, Germany. Electronic address: gasser_m@t-online.de.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: tangtang56love@126.com.'}, {'ForeName': 'Wen-Wei', 'Initials': 'WW', 'LastName': 'Ouyang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: yudexin1984@163.com.'}, {'ForeName': 'Hengqiu', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. Electronic address: 1131968978@qq.com.'}, {'ForeName': 'Shengzhen', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Jiangxi Integrated Traditional Chinese and Western Medicine Hospital, Nanchang, China. Electronic address: 982121880@qq.com.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, Nanchang, China. Electronic address: 64243156@qq.com.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Waaga-Gasser', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: awaaga@bwh.harvard.edu.""}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Guangzhou University of Traditional Chinese Medicine, Guangzhou, China. Electronic address: gzdtcm@gzucm.edu.cn.'}, {'ForeName': 'Meizhen', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: linmeizhen@gzucm.edu.cn.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113096']
1209,32697476,The Effect of Sunflower Seed and Almond Oil on Preterm Infant Skin: A Randomized Controlled Trial.,"OBJECTIVE


To investigate the effect of sunflower seed oil (SSO) and almond oil (AO) on stratum corneum hydration and Neonatal Skin Condition Scores (NSCSs) of preterm infants.
METHODS


This randomized controlled trial recruited 90 preterm infants whose gestational ages were between 32 and 37 weeks in the neonatal ICU. Infants were randomly assigned to three groups (SSO, AO, or control). The oils were applied to the whole body of each infant except for the head and face by a nurse researcher four times a day (4 mL/kg) for 5 days.
MAIN OUTCOME MEASURES


Skin condition of the infants as evaluated with the NSCS; hydration as measured by a skin moisture meter before and after application.
MAIN RESULTS


When average stratum corneum hydration was compared, infants in the SSO and AO groups had better hydration than infants in the control group. The NSCS scores in the control group were significantly higher than in the intervention groups, but there was no difference between the SSO and AO groups.
CONCLUSIONS


Neither SSO nor AO has harmful effects on the skin, and their use may improve stratum corneum hydration. These oils can be used by nurses to hydrate the skin of preterm infants. Further studies are needed to evaluate the efficacy of natural oils on infant skin.",2020,"The NSCS scores in the control group were significantly higher than in the intervention groups, but there was no difference between the SSO and AO groups.
","['90 preterm infants whose gestational ages were between 32 and 37 weeks in the neonatal ICU', 'preterm infants', 'Preterm Infant Skin']","['Sunflower Seed and Almond Oil', 'sunflower seed oil (SSO) and almond oil (AO']","['skin moisture meter', 'stratum corneum hydration and Neonatal Skin Condition Scores (NSCSs', 'NSCS scores']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]","[{'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0102271', 'cui_str': 'almond oil'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0221921', 'cui_str': 'Stratum corneum structure'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C1274236', 'cui_str': 'Neonatal dermatosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",90.0,0.037843,"The NSCS scores in the control group were significantly higher than in the intervention groups, but there was no difference between the SSO and AO groups.
","[{'ForeName': 'Seda', 'Initials': 'S', 'LastName': 'Caglar', 'Affiliation': 'Seda Caglar, PhD, RN, is Assistant Professor, Pediatric Nursing Department, Florence Nightingale Faculty of Nursing, İstanbul University-Cerrahpaşa, İstanbul, Turkey. Gizem Kerimoglu Yildiz, PhD, RN, is Assistant Professor, Hatay School of Health, Hatay Mustafa Kemal University. Ilkay Bakoglu, RN, is Clinical Nurse, and Ozgul Salihoglu, MD, is Associate Professor, Neonatal Intensive Care Unit, Bakirköy Dr. Sadi Konuk Training and Research Hospital, İstanbul. The authors have disclosed no financial relationships related to this article. Submitted August 8, 2019; accepted in revised form October 2, 2019.'}, {'ForeName': 'Gizem Kerimoglu', 'Initials': 'GK', 'LastName': 'Yildiz', 'Affiliation': ''}, {'ForeName': 'Ilkay', 'Initials': 'I', 'LastName': 'Bakoglu', 'Affiliation': ''}, {'ForeName': 'Ozgul', 'Initials': 'O', 'LastName': 'Salihoglu', 'Affiliation': ''}]",Advances in skin & wound care,['10.1097/01.ASW.0000672500.18525.2e']
1210,32702360,Comparison of Long-Term Rotational Stability of Three Commonly Implanted Intraocular Lenses.,"PURPOSE


To compare rotational stability and its influencing factors in 3 different widely used hydrophobic acrylic intraocular lenses (IOLs) from the end of surgery (EoS) to 4-7 months (6 months) in over 380 eyes.
DESIGN


Prospective interventional comparative clinical study.
METHODS


Setting: Department of Ophthalmology, Medical University of Vienna.
PATIENT POPULATION


A total of 381 eyes of 199 patients with age-related cataract received an IOL Acrysof SN60WF, Tecnis ZCB00, or Envista MX60 in a consecutive order.
INTERVENTION


Implantation of an Acrysof, Tecnis, or Envista IOL randomized to the 0 ± 10, 45 ± 10, 90 ± 10, or 135 ± 10° axis in 1 or both eyes. Baseline measurement was performed with patients supine still on the operating table. Postoperative follow-ups were conducted after 1 hour, 1 week, 1 month, and 6 months.
MAIN OUTCOME MEASURES


Difference of absolute rotation from the EoS to 6 months.
RESULTS


Absolute rotations from the EoS to 6 months were 1.65 ± 2.1, 2.65 ± 4.1, and 3.18 ± 5.8° for the Acrysof, Tecnis, and Envista group, respectively. Rotational stability was statistically significantly superior in the Acrysof compared with the Envista group (P = .014), but not compared with the Tecnis group (P = .10). No significant difference was found between the Tecnis and Envista groups (P = .761). Maximum values of 15.8, 38.6, and 44.9° were observed for the Acrysof, Tecnis, and Envista group, respectively.
CONCLUSION


The Acrysof IOL showed the least amount of absolute rotation compared with the Tecnis and Envista IOLs. Outliers possibly requiring secondary intervention were observed in all groups. The amount of rotation was greatest during the first postoperative hour.",2020,"Rotational stability was statistically significantly superior in the Acrysof compared to the Envista group (p=0.014), but not compared to the Tecnis group (p=0.10).",['Medical University of Vienna PATIENT POPULATION: 381 eyes of 199 patients with age-related cataract received an'],"['hydrophobic acrylic intraocular lenses (IOL', 'IOL Acrysof SN60WF, Tecnis ZCB00 or Envista MX60']",['Rotational stability'],"[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4708787', 'cui_str': '381'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}]","[{'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]","[{'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",199.0,0.0268413,"Rotational stability was statistically significantly superior in the Acrysof compared to the Envista group (p=0.014), but not compared to the Tecnis group (p=0.10).","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schartmüller', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Schwarzenbacher', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Elias Laurin', 'Initials': 'EL', 'LastName': 'Meyer', 'Affiliation': 'Section for Medical Statistics, Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schriefl', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. Electronic address: rupert.menapace@meduniwien.ac.at.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.07.019']
1211,32701372,Re: Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial.,,2020,,['Frail Patients Undergoing Resection of Colorectal Cancer'],['Multimodal Prehabilitation vs Postoperative Rehabilitation'],['30-Day Postoperative Complications'],"[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",,0.10665,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Resnick', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001215.02']
1212,32710204,PKPD Modeling and Dosing Considerations in Advanced Ovarian Cancer Patients Treated with Cisplatin-Based Intraoperative Intraperitoneal Chemotherapy.,"Intraperitoneal chemoperfusion (IPEC) of cisplatin is a popular treatment for advanced ovarian cancer, typically under hyperthermia (HIPEC). The use of cisplatin under (H)IPEC is off-label, and the role of hyperthermia is unknown. The aim of this study was to characterize the pharmacokinetic/pharmacodynamic (PKPD) properties of cisplatin under (H)IPEC and to predict the optimal treatment regimen. Using a randomized design, data on intact cisplatin perfusate and plasma concentrations, leukocyte counts-a hematotoxicity marker-and serum creatinine-a nephrotoxicity marker-were collected from 50 patients treated with a combination of cytoreductive surgery (CRS) and either normothermic or hyperthermic IPEC of cisplatin dosed at 75, 100, and 120 mg/m 2 . The non-linear mixed effects modeling technique was used to construct the PKPD models. The PK of intact cisplatin was characterized by a two-compartment model. A semi-physiological myelosuppression model for the leukopenia was modified to account for the CRS-induced leukocytosis and the residual myelosuppression effect of neoadjuvant chemotherapy. The incidence and severity of nephrotoxicity were described by a discrete-time Markov model. Hyperthermia increased the absorption rate of cisplatin by 16.3% but did not show a clinically relevant impact on the investigated toxicities compared with normothermia. Leukopenia was not severe, but nephrotoxicity can become severe or life-threatening and was affected by the dose and IPEC duration. The model predicted that nephrotoxicity is minimal at a cisplatin dose of 75 mg/m 2  with an IPEC duration of 1-2 h and an 1-h duration is favored for doses between 100 and 120 mg/m 2 . Graphical abstract.",2020,Hyperthermia increased the absorption rate of cisplatin by 16.3% but did not show a clinically relevant impact on the investigated toxicities compared with normothermia.,"['advanced ovarian cancer, typically under hyperthermia (HIPEC', '50 patients treated with a combination of cytoreductive surgery (CRS) and either', 'Advanced Ovarian Cancer Patients Treated with']","['Intraperitoneal chemoperfusion (IPEC) of cisplatin', 'cisplatin under (H)IPEC', 'normothermic or hyperthermic IPEC of cisplatin', 'Cisplatin-Based Intraoperative Intraperitoneal Chemotherapy']","['incidence and severity of nephrotoxicity', 'toxicities', 'Leukopenia', 'plasma concentrations, leukocyte counts-a hematotoxicity marker-and serum creatinine-a nephrotoxicity marker', 'absorption rate of cisplatin']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}]","[{'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0920103', 'cui_str': 'Haematotoxicity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]",,0.0393438,Hyperthermia increased the absorption rate of cisplatin by 16.3% but did not show a clinically relevant impact on the investigated toxicities compared with normothermia.,"[{'ForeName': 'Feifan', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Division of Biopharmaceutics and Pharmacokinetics, Xiangya School of Pharmaceutical Sciences, Central South University, Tongzipo Road 172, Changsha, 410013, China. feifan.xie@csu.edu.cn.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Van Bocxlaer', 'Affiliation': 'Laboratory of Medical Biochemistry and Clinical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000, Ghent, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Colin', 'Affiliation': 'Laboratory of Medical Biochemistry and Clinical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000, Ghent, Belgium.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Carlier', 'Affiliation': 'Department of GI Surgery, Ghent University Hospital, 9000, Ghent, Belgium.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Van Kerschaver', 'Affiliation': 'Department of Surgery, St. Lucas Andreas Hospital, 9000, Ghent, Belgium.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Weerts', 'Affiliation': 'Department of Surgery, CHC, Liège, Belgium.'}, {'ForeName': 'Hannelore', 'Initials': 'H', 'LastName': 'Denys', 'Affiliation': 'Cancer Research Institute Ghent (CRIG), 9000, Ghent, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Tummers', 'Affiliation': 'Department of Gynecology, Ghent University Hospital, 9000, Ghent, Belgium.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Willaert', 'Affiliation': 'Department of GI Surgery, Ghent University Hospital, 9000, Ghent, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Ceelen', 'Affiliation': 'Department of GI Surgery, Ghent University Hospital, 9000, Ghent, Belgium.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Vermeulen', 'Affiliation': 'Laboratory of Medical Biochemistry and Clinical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000, Ghent, Belgium.'}]",The AAPS journal,['10.1208/s12248-020-00489-2']
1213,32611638,Minimal manifestation status and prednisone withdrawal in the MGTX trial.,"OBJECTIVE


To examine whether sustained minimal manifestation status (MMS) with complete withdrawal of prednisone is better achieved in thymectomized patients with myasthenia gravis (MG).
METHODS


This study is a post hoc analysis of data from a randomized trial of thymectomy in MG (Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy [MGTX]). MGTX was a multicenter, randomized, rater-blinded 3-year trial that was followed by a voluntary 2-year extension for patients with acetylcholine receptor (AChR) antibody-positive MG without thymoma. Patients were randomized 1:1 to thymectomy plus prednisone vs prednisone alone. Participants were age 18-65 years at enrollment with disease duration less than 5 years. All patients received oral prednisone titrated up to 100 mg on alternate days until they achieved MMS, which prompted a standardized prednisone taper as long as MMS was maintained. The achievement rate of sustained MMS (no symptoms of MG for 6 months) with complete withdrawal of prednisone was compared between the thymectomy plus prednisone and prednisone alone groups.
RESULTS


Patients with MG in the thymectomy plus prednisone group achieved sustained MMS with complete withdrawal of prednisone more frequently (64% vs 38%) and quickly compared to the prednisone alone group (median time 30 months vs no median time achieved,  p  < 0.001) over the 5-year study period. Prednisone-associated adverse symptoms were more frequent in the prednisone alone group and distress level increased with higher doses of prednisone.
CONCLUSIONS


Thymectomy benefits patients with MG by increasing the likelihood of achieving sustained MMS with complete withdrawal of prednisone.
CLINICALTRIALSGOV IDENTIFIER


NCT00294658.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that for patients with generalized MG with AChR antibody, those receiving thymectomy plus prednisone are more likely to attain sustained MMS and complete prednisone withdrawal than those on prednisone alone.",2020,"Prednisone associated adverse symptoms were more frequent in the prednisone alone group and distress level increased with higher doses of prednisone.
","['generalized MG patients with AChR antibody, those receiving', 'thymectomized myasthenia gravis (MG) patients', 'patients with acetylcholine receptor (AChR) antibody positive MG without thymoma', 'Participants were age 18-65 years at enrollment with disease duration less than 5 years', 'myasthenia gravis (MGTX']","['prednisone', 'thymectomy plus prednisone', 'Prednisone', 'MGTX', 'thymectomy', 'oral prednisone', 'thymectomy plus prednisone versus prednisone alone']","['achievement rate of sustained MMS', 'distress level', 'sustained MMS', 'adverse symptoms']","[{'cui': 'C0472367', 'cui_str': 'Generalized myasthenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0236516', 'cui_str': 'Acetylcholine receptor antibody'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}, {'cui': 'C0034792', 'cui_str': 'Cholinergic receptor'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C0040100', 'cui_str': 'Thymoma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0174725', 'cui_str': 'margatoxin'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0040071', 'cui_str': 'Excision of thymus'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0174725', 'cui_str': 'margatoxin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.173208,"Prednisone associated adverse symptoms were more frequent in the prednisone alone group and distress level increased with higher doses of prednisone.
","[{'ForeName': 'Ikjae', 'Initials': 'I', 'LastName': 'Lee', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY. leeij15@gmail.com.'}, {'ForeName': 'Hui-Chien', 'Initials': 'HC', 'LastName': 'Kuo', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Inmaculada B', 'Initials': 'IB', 'LastName': 'Aban', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Tarrant', 'Initials': 'T', 'LastName': 'McPherson', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Kaminski', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Sussman', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Ströbel', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Oger', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Cea', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Jeannine M', 'Initials': 'JM', 'LastName': 'Heckmann', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Evoli', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Wilfred', 'Initials': 'W', 'LastName': 'Nix', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Ciafaloni', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Antonini', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Rawiphan', 'Initials': 'R', 'LastName': 'Witoonpanich', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'John O', 'Initials': 'JO', 'LastName': 'King', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Said R', 'Initials': 'SR', 'LastName': 'Beydoun', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Colin H', 'Initials': 'CH', 'LastName': 'Chalk', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Alexandru C', 'Initials': 'AC', 'LastName': 'Barboi', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Amato', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Aziz I', 'Initials': 'AI', 'LastName': 'Shaibani', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Bashar', 'Initials': 'B', 'LastName': 'Katirji', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Bryan R F', 'Initials': 'BRF', 'LastName': 'Lecky', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Buckley', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Vincent', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Elza', 'Initials': 'E', 'LastName': 'Dias-Tosta', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Yoshikawa', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Waddington-Cruz', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Pulley', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Rivner', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kostera-Pruszczyk', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Pascuzzi', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Carlayne E', 'Initials': 'CE', 'LastName': 'Jackson', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Jan J G', 'Initials': 'JJG', 'LastName': 'Verschuuren', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Massey', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Kissel', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Lineu C', 'Initials': 'LC', 'LastName': 'Werneck', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Benatar', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Barohn', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Rup', 'Initials': 'R', 'LastName': 'Tandan', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Tahseen', 'Initials': 'T', 'LastName': 'Mozaffar', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Conwit', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Minisman', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Sonett', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Gil I', 'Initials': 'GI', 'LastName': 'Wolfe', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000010031']
1214,32611643,Suitability of external controls for drug evaluation in Duchenne muscular dystrophy.,"OBJECTIVE


To evaluate the suitability of real-world data (RWD) and natural history data (NHD) for use as external controls in drug evaluations for ambulatory Duchenne muscular dystrophy (DMD).
METHODS


The consistency of changes in the 6-minute walk distance (Δ6MWD) was assessed across multiple clinical trial placebo arms and sources of NHD/RWD. Six placebo arms reporting 48-week Δ6MWD were identified via literature review and represented 4 sets of inclusion/exclusion criteria (n = 383 patients in total). Five sources of RWD/NHD were contributed by Universitaire Ziekenhuizen Leuven, DMD Italian Group, The Cooperative International Neuromuscular Research Group, ImagingDMD, and the PRO-DMD-01 study (n = 430 patients, in total). Mean Δ6MWD was compared between each placebo arm and RWD/NHD source after subjecting the latter to the inclusion/exclusion criteria of the trial for baseline age, ambulatory function, and steroid use. Baseline covariate adjustment was investigated in a subset of patients with available data.
RESULTS


Analyses included ∼1,200 patient-years of follow-up. Differences in mean Δ6MWD between trial placebo arms and RWD/NHD cohorts ranged from -19.4 m (i.e., better outcomes in RWD/NHD) to 19.5 m (i.e., worse outcomes in RWD/NHD) and were not statistically significant before or after covariate adjustment.
CONCLUSIONS


We found that Δ6MWD was consistent between placebo arms and RWD/NHD subjected to equivalent inclusion/exclusion criteria. No evidence for systematic bias was detected. These findings are encouraging for the use of RWD/NHD to augment, or possibly replace, placebo controls in DMD trials. Multi-institution collaboration through the Collaborative Trajectory Analysis Project rendered this study feasible.",2020,The consistency of changes in the six-minute walk distance (Δ6MWD) was compared across multiple clinical trial placebo arms and sources of NHD/RWD.,"['ambulatory Duchenne muscular dystrophy (DMD', 'Duchenne muscular dystrophy']","['real-world data (RWD) and natural history data (NHD', 'Six placebo', 'placebo']","['Mean Δ6MWD', 'mean Δ6MWD']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}]","[{'cui': 'C0175860', 'cui_str': 'Natural History'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}]",430.0,0.447587,The consistency of changes in the six-minute walk distance (Δ6MWD) was compared across multiple clinical trial placebo arms and sources of NHD/RWD.,"[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Goemans', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Signorovitch', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy.""}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Sajeev', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy.""}, {'ForeName': 'Zhiwen', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy.""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gordish-Dressman', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy.""}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'McDonald', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy.""}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Vandenborne', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy.""}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy.""}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Ward', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy.""}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Mercuri', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy. eugeniomaria.mercuri@unicatt.it.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000010170']
1215,32690404,"Re: Michael S. Hofman, Nathan Lawrentschuk, Roslyn J. Francis, et al. Prostate-specific Membrane Antigen PET-CT in Patients with High-risk Cancer Before Curative-intent Surgery or Radiotherapy (proPSMA): A Prospective, Randomized, Multicenter Study. Lancet 2020;395:1208-16.",,2020,,['Patients with High-risk Cancer'],"['Curative-intent Surgery or Radiotherapy (proPSMA', 'Prostate-specific Membrane Antigen PET-CT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}]",[],,0.0238972,,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Evangelista', 'Affiliation': 'Nuclear Medicine Unit, Department of Medicine, University of Padua, Padua, Italy. Electronic address: laura.evangelista@unipd.it.'}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'De Salvo', 'Affiliation': 'Clinical Trials and Biostatistics Unit, IRCCS Istituto Oncologico Veneto, Padova, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Zattoni', 'Affiliation': 'Urology Unit, Academic Medical Centre Hospital, Udine, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Novara', 'Affiliation': 'Department of Surgery, Oncology, and Gastroenterology, Urology Clinic, University of Padua, Padua, Italy.'}]",European urology oncology,['10.1016/j.euo.2020.06.013']
1216,32715915,"Re: Evaluating the Safety and Potential Activity of URO-902 (hMaxi-K) Gene Transfer by Intravesical Instillation or Direct Injection into the Bladder Wall in Female Participants with Idiopathic (Non-Neurogenic) Overactive Bladder Syndrome and Detrusor Overactivity from Two Double-Blind, Imbalanced, Placebo-Controlled Randomized Phase 1 Trials.",,2020,,['Female Participants with Idiopathic (Non-Neurogenic) Overactive Bladder Syndrome and Detrusor Overactivity'],"['URO-902', 'hMaxi-K) Gene Transfer by Intravesical Instillation or Direct Injection']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0268849', 'cui_str': 'Detrusor overactivity'}]","[{'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0021917', 'cui_str': 'Instillation of bladder'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",[],,0.212251,,"[{'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001223.02']
1217,32717713,"Effect of lifetime antiepileptic drug treatment history on efficacy and tolerability of adjunctive brivaracetam in adults with focal seizures: Post-hoc analysis of a randomized, placebo-controlled trial.","OBJECTIVE


To evaluate the efficacy and tolerability of adjunctive brivaracetam (BRV) in adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs).
METHODS


Post-hoc analysis of data from N01358 (NCT01261325), a randomized, double-blind, placebo (PBO)-controlled Phase III trial evaluating BRV 100 and 200 mg/day in patients ≥16 years of age with uncontrolled focal seizures. Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
RESULTS


764 patients received at least one dose of trial medication (BRV: 503; PBO: 261; Safety Set), of whom 14.3% had 1-2, 20.8% had 3-4, 21.3% had 5-6, and 43.6% had ≥7 lifetime AEDs. In all lifetime AED subgroups, >85% of patients completed the trial. Patients with a higher number of lifetime AEDs had a younger age at epilepsy onset, longer epilepsy duration, and higher baseline seizure frequency. In patients on BRV, 50% responder rates were 49.3%, 44.4%, 47.2% and 27.4% in patients with 1-2 (n = 75), 3-4 (n = 99), 5-6 (n = 108) and ≥7 (n = 219) lifetime AEDs; 75% responder rates were 36.0%, 21.2%, 22.2% and 12.3%. In patients on PBO, 50% responder rates were 35.3%, 25.9%, 20.4% and 15.9% in patients with 1-2 (n = 34), 3-4 (n = 58), 5-6 (n = 54) and ≥7 (n = 113) lifetime AEDs; 75% responder rates were 26.5%, 6.9%, 3.7% and 4.4%. The Kaplan-Meier estimated probability of patients achieving a sustained 50% or 75% response from the first day of treatment was generally higher in patients with a lower number of lifetime AEDs (both in patients on BRV and PBO). In patients on adjunctive BRV, the incidence of drug related treatment-emergent adverse events (TEAEs) was 34.7%, 26.0%, 44.4% and 47.7% in patients with 1-2 (n = 75), 3-4 (n = 100), 5-6 (n = 108) and ≥7 (n = 220) lifetime AEDs; the incidence of discontinuations due to TEAEs was 1.3%, 3.0%, 8.3% and 10.5%.
CONCLUSIONS


This post-hoc analysis suggests a numerically higher response to adjunctive BRV in patients with fewer lifetime AEDs. The lowest response was observed in patients with ≥7 lifetime AEDs, although these patients could also benefit from adjunctive BRV treatment. Patients with fewer lifetime AEDs had lower discontinuation of BRV due to TEAEs.",2020,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","['adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs', 'adults with focal seizures', 'subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs', 'patients ≥16 years of age with uncontrolled focal seizures']","['adjunctive brivaracetam (BRV', 'adjunctive brivaracetam', 'placebo']","['Efficacy and tolerability outcomes', 'responder rates', 'incidence of drug related treatment-emergent adverse events (TEAEs', 'efficacy and tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}]","[{'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",764.0,0.103758,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, 6410 Rockledge Drive, Suite 610, Bethesda, MD 20817, USA. Electronic address: kleinp@epilepsydc.com.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McLachlan', 'Affiliation': 'Western University, 339 Windermere Road, London, ON N6A 5A5, Canada. Electronic address: rsmcl@uwo.ca.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Foris', 'Affiliation': 'UCB Pharma, 2060 Winston Park Drive, Suite 401, Oakville, ON L6H 5R7, Canada. Electronic address: kforis@sympatico.ca.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Nondonfaz', 'Affiliation': ""UCB Pharma, Chemin du Foriest, 1420 Braine-l'Alleud, Belgium. Electronic address: xavier.nondonfaz@ucb.com.""}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: sami.elmoufti@ucb.com.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Dimova', 'Affiliation': 'UCB Pharma, Allée de la Recherche 60, 1070 Brussels, Belgium. Electronic address: svetlana.dimova@ucb.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Center, Mara Hospital, Maraweg 21, 33617 Bielefeld, Germany. Electronic address: christian.brandt@mara.de.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106369']
1218,32729763,The effects of moderate alterations in adrenergic activity on acute appetite regulation in obese women: A randomised crossover trial.,"BACKGROUND


Previous evidence has demonstrated that serum leptin is correlated with appetite in combination with, but not without, modest exercise.
AIM


The present experiments investigated the effects of exogenous adrenaline and α/β adrenoceptor blockade in combination with moderate exercise on serum leptin concentrations, appetite/satiety sensations and subsequent food intake in obese women.
METHODS


A total of 10 obese women ((mean ± SEM), age: 50 (1.9) years, body mass index 36 (4.1) kg/m 2 , waist 104.8 (4.1) cm) participated in two separate, double-blind randomised experimental trials. Experiment 1: moderate exercise after α/β adrenergic blocker (labetalol, 100 mg orally) versus moderate exercise plus placebo; experiment 2: adrenaline infusion for 20 minutes versus saline infusion. Appetite/satiety and biochemistry were measured at baseline, pre- and immediately post-intervention, then 1 hour post-intervention (i.e., before dinner). Food intake was assessed via ad libitum buffet-style dinner.
RESULTS


No differences were found in appetite/satiety, subsequent food intake or serum leptin in any of the studies (experiment 1 or experiment 2). In experiment 1, blood glucose was higher ( p  < 0.01) and plasma free fatty acids lower ( p  = 0.04) versus placebo. In experiment 2, plasma free fatty acids ( p  < 0.05) increased after adrenaline versus saline infusion.
CONCLUSIONS


Neither inhibition of exercise-induced adrenergic activity by combined α/β adrenergic blockade nor moderate increases in adrenergic activity induced by intravenous adrenaline infusion affected acute appetite regulation.",2020,"No differences were found in appetite/satiety, subsequent food intake or serum leptin in any of the studies (experiment 1 or experiment 2).","['10 obese women ((mean ± SEM), age: 50 (1.9) years, body mass index 36 (4.1) kg/m 2 , waist 104.8 (4.1) cm', 'obese women']","['adrenaline infusion', 'moderate exercise after α/β adrenergic blocker (labetalol, 100 mg orally) versus moderate exercise plus placebo', 'exogenous adrenaline and α/β adrenoceptor blockade', 'adrenaline', 'placebo']","['Appetite/satiety and biochemistry', 'blood glucose', 'plasma free fatty acids lower', 'plasma free fatty acids', 'Food intake', 'appetite/satiety, subsequent food intake or serum leptin', 'serum leptin concentrations, appetite/satiety sensations and subsequent food intake', 'adrenergic activity']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242889', 'cui_str': 'Substance with adrenergic receptor antagonist mechanism of action'}, {'cui': 'C0022860', 'cui_str': 'Labetalol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",10.0,0.382086,"No differences were found in appetite/satiety, subsequent food intake or serum leptin in any of the studies (experiment 1 or experiment 2).","[{'ForeName': 'Fotini', 'Initials': 'F', 'LastName': 'Tsofliou', 'Affiliation': 'Human Nutrition, School of Medicine, 3526University of Glasgow, United Kingdom.'}, {'ForeName': 'Yannis P', 'Initials': 'YP', 'LastName': 'Pitsiladis', 'Affiliation': 'College of Medical Veterinary and Life Science, Institute of Cardiovascular & Medical Sciences, 3526University of Glasgow, United Kingdom.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lara', 'Affiliation': 'Department of Applied Sciences, Faculty of Health and Life Sciences, 5995Northumbria University, United Kingdom.'}, {'ForeName': 'Marios', 'Initials': 'M', 'LastName': 'Hadjicharalambous', 'Affiliation': 'College of Medical Veterinary and Life Science, Institute of Cardiovascular & Medical Sciences, 3526University of Glasgow, United Kingdom.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Macdonald', 'Affiliation': ""School of Life Sciences, 6123University of Nottingham Medical School, Queen's Medical Centre, United Kingdom.""}, {'ForeName': 'Mike A', 'Initials': 'MA', 'LastName': 'Wallace', 'Affiliation': 'University Department of Pathological Biochemistry, Glasgow Royal Infirmary, United Kingdom.'}, {'ForeName': 'Mike E J', 'Initials': 'MEJ', 'LastName': 'Lean', 'Affiliation': 'Human Nutrition, School of Medicine, 3526University of Glasgow, United Kingdom.'}]",Nutrition and health,['10.1177/0260106020942117']
1219,32701823,Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) From Dolutegravir (DTG)+F/TAF or DTG+F/Tenofovir Disoproxil Fumarate (TDF) in the Presence of Pre-existing NRTI Resistance.,"BACKGROUND


Study 4030 was a phase 3, randomized, double-blinded study of 565 HIV-1 RNA-suppressed participants switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) or dolutegravir (DTG)+F/TAF. Nucleoside reverse transcriptase inhibitor (NRTI), non-NRTI, and protease inhibitor resistance (-R) was allowed, but integrase strand transfer inhibitor-R was excluded. Here, we describe the detailed resistance analysis.
METHODS


Historical plasma HIV-1 RNA genotypes and baseline proviral DNA genotypes were analyzed. Documented or investigator-suspected NRTI-R was grouped for stratification into 3 categories of level of resistance. Viral blips were assessed through week 48. Virologic failures had genotypic and phenotypic resistance analyses at week 48, confirmed failure, or last visit, if HIV-1 RNA did not resuppress to <50 copies/mL while on study drug.
RESULTS


In total, 83% (470/565) of participants had baseline genotypic data available with NRTI-R detected in 24% (138/565), including 5% (30/565) with K65R/E/N or ≥3 thymidine analog mutations and 19% (108/565) with other NRTI-R mutations. M184V/I was present in 14% (81/565). Pre-existing integrase strand transfer inhibitor-R mutations were found in 4% (20/565) of participants. Primary non-NRTI-R and protease inhibitor-R mutations were present in 21% (118/565) and 7% (38/565) of participants. High rates of viral suppression were maintained in all groups through week 48; blips were observed in only 15 participants (2.7%). Three participants met criteria for resistance analysis (all in DTG+F/TAF arm); none developed treatment-emergent resistance to study drugs.
CONCLUSIONS


Participants with baseline NRTI resistance, much of which was previously undocumented, maintained suppression 48 weeks after switching to B/F/TAF or DTG+F/TAF triple therapy. Blips and virologic failure were uncommon using either regimen, with no treatment-emergent resistance.",2020,High rates of viral suppression were maintained in all groups through Week 48; blips were observed in only 15 participants (2.7%).,"['Three participants met criteria for resistance analysis (all in DTG+F/TAF arm); none developed treatment-emergent resistance to study drugs', '565 HIV-1 RNA suppressed participants switching to']","['bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) or dolutegravir (DTG)+F/TAF', 'Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) from Dolutegravir (DTG)+F/TAF or DTG+F/Tenofovir Disoproxil Fumarate (TDF']","['NRTI, NNRTI, and PI resistance (-R', 'High rates of viral suppression', 'Primary NNRTI-R and PI-R mutations', 'Viral blips', 'Blips and virologic failure']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1450557', 'cui_str': 'IGFBP7 protein, human'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}]","[{'cui': 'C4542162', 'cui_str': 'emtricitabine, tenofovir alafenamide and bictegravir'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1450557', 'cui_str': 'IGFBP7 protein, human'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1699206', 'cui_str': 'Virologic failure'}]",565.0,0.237309,High rates of viral suppression were maintained in all groups through Week 48; blips were observed in only 15 participants (2.7%).,"[{'ForeName': 'Rima K', 'Initials': 'RK', 'LastName': 'Acosta', 'Affiliation': 'Gilead Sciences, Foster City, CA.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Willkom', 'Affiliation': ''}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Andreatta', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Aiyappa', 'Initials': 'A', 'LastName': 'Parvangada', 'Affiliation': ''}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'White', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002454']
1220,32712103,Progression of Fatty Liver Disease in Children Receiving Standard of Care Lifestyle Advice.,"BACKGROUND & AIMS


Nonalcoholic fatty liver disease (NAFLD) is the most common pediatric chronic liver disease. Little is known about outcomes in recognized youth.
METHODS


We compared paired liver biopsies from 122 of 139 children with NAFLD (74% male; 64% white; 71% Hispanic; mean age, 13 ± 3 years; age range, 8-17 years) who received placebo and standard of care lifestyle advice in 2 double-blind, randomized clinical trials within the nonalcoholic steatohepatitis (NASH) clinical research network from 2005 through 2015. We analyzed histologic changes with respect to baseline and longitudinal change in clinical variables using regression analysis.
RESULTS


At enrollment, 31% of the children had definite NASH, 34% had borderline zone 1 NASH, 13% had borderline zone 3 NASH, and 21% had fatty liver but not NASH. Over a mean period of 1.6 ± 0.4 years, borderline or definite NASH resolved in 29% of the children, whereas 18% of the children with fatty liver or borderline NASH developed definite NASH. Fibrosis improved in 34% of the children but worsened in 23%. Any progression to definite NASH or in fibrosis occurred in 36% of the children, and both occurred in 11% of the children. Any improvement in NASH or fibrosis occurred in 52%, and both occurred in 20% of children. Type 2 diabetes developed in 5% of the cohort. Any progression to NASH and/or fibrosis was associated with adolescent age, higher waist circumference, levels of alanine or aspartate aminotransferase, total and low-density lipoprotein-cholesterol at baseline, increasing level of alanine aminotransferase, and hemoglobin A1C (P < .05). Progression to NASH and/or fibrosis were also associated with increasing level of gamma-glutamyl transferase and development of type 2 diabetes (P < .01). Increasing level of gamma-glutamyl transferase also associated with reduced odds of any improvement (P = .003).
CONCLUSIONS


One-third of children with NAFLD enrolled in placebo groups of clinical trials had histologic features of progression within 2 years, in association with increasing obesity and serum levels of aminotransferases and loss of glucose homeostasis.",2020,"Increasing level of gamma-glutamyl transferase also associated with reduced odds of any improvement (P=.003).
","['We compared paired liver biopsies from 122 of 139 children with NAFLD (74% male; 64% white; 71% Hispanic; mean age, 13±3 years; age range, 8-17 years) who received', 'Children Receiving Standard of Care Lifestyle Advice']","['placebo and standard of care lifestyle advice', 'placebo', 'NASH']","['Increasing level of gamma-glutamyl transferase', 'Fibrosis', 'borderline or definite NASH', 'level of gamma-glutamyl transferase and development of type 2 diabetes', 'obesity and serum levels of aminotransferases and loss of glucose homeostasis', 'NASH or fibrosis', 'waist circumference, levels of alanine or aspartate aminotransferase, total and low density lipoprotein cholesterol at baseline, increasing level of alanine aminotransferase, hemoglobin A1C (P<.05']","[{'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",139.0,0.180644,"Increasing level of gamma-glutamyl transferase also associated with reduced odds of any improvement (P=.003).
","[{'ForeName': 'Stavra A', 'Initials': 'SA', 'LastName': 'Xanthakos', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Lavine', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Columbia Vagelos College of Physicians and Surgeons, New York, New York. Electronic address: jl3553@columbia.edu.'}, {'ForeName': 'Katherine P', 'Initials': 'KP', 'LastName': 'Yates', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Schwimmer', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California San Diego School of Medicine, La Jolla, California.'}, {'ForeName': 'Jean P', 'Initials': 'JP', 'LastName': 'Molleston', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Indiana University School of Medicine/Riley Hospital for Children, Indianapolis, Indiana.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Rosenthal', 'Affiliation': ""Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California, Benioff Children's Hospital, San Francisco, California.""}, {'ForeName': 'Karen F', 'Initials': 'KF', 'LastName': 'Murray', 'Affiliation': ""Pediatrics Institute, Cleveland Clinic Children's, Cleveland, Ohio.""}, {'ForeName': 'Miriam B', 'Initials': 'MB', 'LastName': 'Vos', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, Georgia.""}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Jain', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, St. Louis University, St. Louis, Missouri.'}, {'ForeName': 'Ann O', 'Initials': 'AO', 'LastName': 'Scheimann', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Tamir', 'Initials': 'T', 'LastName': 'Miloh', 'Affiliation': 'Miami Transplant Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Fishbein', 'Affiliation': 'Department of Pediatrics, Feinberg Medical School of Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Behling', 'Affiliation': 'Department of Pathology, Sharp Memorial Hospital; Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California, San Diego, California.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Brunt', 'Affiliation': 'Department of Pathology and Immunology, Washington University, St. Louis, Missouri.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastroenterology,['10.1053/j.gastro.2020.07.034']
1221,32719096,Effect of random deferral of percutaneous coronary intervention in patients with diabetes and stable ischaemic heart disease.,"BACKGROUND


In stable ischaemic heart disease (SIHD), measurement of fractional flow reserve (FFR) to guide selection of lesions for percutaneous coronary intervention (PCI) reduces death and myocardial infarction (MI) compared with angiographic guidance. However, it is unknown if the improved outcomes are due to avoidance of stenting of physiologically insignificant lesions or are a by-product of placing fewer stents.
METHODS


We developed a Monte Carlo simulation using the PCI strata of the Bypass Angioplasty Revascularization Investigation 2 Diabetes study to investigate how random deferral of PCI impacts outcomes. To simulate deferral, a randomly selected group of patients randomised to PCI were removed and replaced by an equal number of randomly selected patients randomised to intensive medical therapy (IMT) using a random number generator in Python's NumPy module. The primary endpoint was the rate of death or non-fatal MI at 1 year.
RESULTS


Death/MI at 1 year occurred in 8.3% of 798 patients in the PCI group and 5.1% of 807 patients in the IMT control group (p=0.02). Following 10 000 iterations of random replacement of 10%, 20%, 30% or 40% of PCI patients with randomly selected IMT patients, the rate of death/MI at 1 year progressively declined from 8.3% to 8.0%, 7.6%, 7.3% and 7.0%, respectively.
CONCLUSIONS


In this simulation model, random deferral of PCI procedures in SIHD progressively reduced death/MI as the percentage of procedures deferred increases. FFR-guided deferral of PCI may improve outcomes as a result of placing fewer stents and be unrelated to the haemodynamic severity of lesions.",2020,"RESULTS


Death/MI at 1 year occurred in 8.3% of 798 patients in the PCI group and 5.1% of 807 patients in the IMT control group (p=0.02).",['patients with diabetes and stable ischaemic heart disease'],"['percutaneous coronary intervention (PCI', ""intensive medical therapy (IMT) using a random number generator in Python's NumPy module"", 'percutaneous coronary intervention', 'PCI']","['rate of death or non-fatal MI', 'death and myocardial infarction (MI', 'Death/MI', 'rate of death/MI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0206304', 'cui_str': 'Genus Python'}, {'cui': 'C3542953', 'cui_str': 'Module'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]",,0.0477253,"RESULTS


Death/MI at 1 year occurred in 8.3% of 798 patients in the PCI group and 5.1% of 807 patients in the IMT control group (p=0.02).","[{'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Department of Medicine, Washington University in St Louis, St Louis, Missouri, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Brown', 'Affiliation': 'Cardiovascular Division, Washington University in St Louis, St Louis, Missouri, USA d.brown@wustl.edu.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2019-316432']
1222,32720367,Comparison of pleural effusion between fenestrated and nonfenestrated extracardiac Fontan: A prospective randomized study.,"BACKGROUND


Fenestration of the baffle/conduit is believed to reduce pleural effusion following the Fontan operation. However, equivocal results have been observed with or without fenestration. This study aims to evaluate the efficacy of fenestration on the amount and duration of pleural effusion following the Fontan operation.
METHODS


About 40 patients undergoing extracardiac Fontan (ECF) were randomized into two groups: one with fenestration (ECF-F; n = 20) or without fenestration (ECF-NF; n = 20). Primary outcome was the amount and duration of pleural effusions. Secondary outcomes were time to removal of the chest tubes, hospital stay, and readmission to the hospital because of recurrent pleural within 30 days of the operation.
RESULTS


Mean age was 11.5 ± 5.07 (range, 8.7-13.5) years in the ECF-F group and 13.6 ± 0.4 years (range, 10.5-15.5) in the (ECF-NF) group. The total drain output was 7.89 mL/kg/d in ECF-NF compared with 6.9 mL/kg/d in the ECF-group (P = .14). Time for removal of pleural tubes was 14.6 ± 0.95 days in the ECF-NF group compared with 11.6 ± days in the ECF-F group. Total duration of hospital stay was higher but not significant in the ECF-NF group compared with the ECF-F group. Two patients in ECF-NF required readmission to the hospital within 30 days following discharge, while there were no readmissions in the ECF-F group.
CONCLUSION


Contrary to the literature, the creation of a fenestration in the ECF circuit was not clearly associated with a reduction in the amount and duration of pleural effusion compared with a non-fenestrated Fontan. These findings may be debatable in high risks versus low risk candidates. However in the present study, in a low risk canditates undergoing the Fontan operation, the daily amount of pleural drainage was no different. Larger studies are needed to confirm these findings.",2020,Total duration of hospital stay was higher but not significant in the ECF-NF group compared with the ECF-F group.,"['Mean age was 11.5\u2009±\u20095.07 (range, 8.7-13.5) years in the ECF-F group and 13.6\u2009±\u20090.4 years (range, 10.5-15.5) in the (ECF-NF) group', 'pleural effusion between fenestrated and nonfenestrated extracardiac Fontan', '40 patients undergoing extracardiac Fontan (ECF']",['fenestration (ECF-F; n\u2009=\u200920) or without fenestration (ECF-NF'],"['Time for removal of pleural tubes', 'amount and duration of pleural effusions', 'total drain output', 'time to removal of the chest tubes, hospital stay, and readmission to the hospital because of recurrent pleural within 30 days of the operation', 'Total duration of hospital stay']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C4517559', 'cui_str': '13.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441840', 'cui_str': 'Group F'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015825', 'cui_str': 'Inner ear fenestration'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1522720', 'cui_str': 'Pleural'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",40.0,0.0456897,Total duration of hospital stay was higher but not significant in the ECF-NF group compared with the ECF-F group.,"[{'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Talwar', 'Affiliation': 'Department of Biostatistics, Cardiothoracic Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Adarsh', 'Initials': 'A', 'LastName': 'Paidi', 'Affiliation': 'Department of Biostatistics, Cardiothoracic Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vishnubhatla', 'Initials': 'V', 'LastName': 'Sreeniwas', 'Affiliation': 'Department of Biostatistics, Cardiothoracic Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Dutt Upadhyay', 'Affiliation': 'Department of Biostatistics, Cardiothoracic Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sambhunath', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Department of Biostatistics, Cardiothoracic Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Shiv K', 'Initials': 'SK', 'LastName': 'Choudhary', 'Affiliation': 'Department of Biostatistics, Cardiothoracic Center, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of cardiac surgery,['10.1111/jocs.14886']
1223,32725772,"Associations between muscle measures, survival, and toxicity in patients with limited stage small cell lung cancer.","BACKGROUND


Standard treatment for patients with limited stage small cell lung cancer (LS SCLC) is concurrent platinum-etoposide chemotherapy and thoracic radiotherapy (TRT). Up to 30% of patients are cured, but severe toxicity is common, and we are not able to identify those who are cured or those who experience severe toxicity before chemoradiotherapy commences. Studies of other cancer patients show that low muscle mass and muscle radiodensity are associated with inferior survival and that a high drug dose per kilogram lean body mass (LBM) is associated with more toxicity, but this has not been investigated in LS SCLC. We analysed patients from a randomized trial comparing two schedules of TRT (n = 157) to investigate the prognostic and predictive role of these muscle measures in LS SCLC.
METHODS


Patients from a trial comparing once daily hypofractionated with twice daily hyperfractionated TRT were analysed. The skeletal muscle index (SMI), skeletal muscle radiodensity (SMD), and LBM were assessed from baseline computed tomography scans at the L3 level using the SliceOMatic software.
RESULTS


Images at the L3 level were available for 122 patients (77.7%). Median age was 64 years, 18% had performance status 2, and 38% had stage III. Grade 3-4 toxicity was observed in 89%, and 5% died from treatment-related side effects. Overall, the median overall survival was 23 months, and the 5 year survival was 25%. Median LBM was 45.2 (range: 16-65) kg, the median SMI 44.8 (range: 29-77) cm 2  /m 2  , and the median SMD 39.3 (range 16-62) HU. There were no significant associations between survival and any of the muscle measures in the univariable analyses (SMI: P = 0.906, SMD: P = 0.829) or in multivariable analyses adjusting for baseline characteristics (SMI: P = 0.836, SMD: P = 0.260). A higher cisplatin dose per kilogram LBM in the first course significantly increased the risk of grade 3-4 haematological toxicity (P = 0.011) and neutropenic infections (P = 0.012).
CONCLUSIONS


Patients who received a high dose of cisplatin per kilogram LBM had more haematological toxicity and neutropenic infections than other patients. None of the muscle measures were independent prognostic factors for survival in our cohort of LS SCLC patients who underwent standard chemoradiotherapy.",2020,"There were no significant associations between survival and any of the muscle measures in the univariable analyses (SMI: P = 0.906, SMD: P = 0.829) or in multivariable analyses adjusting for baseline characteristics (SMI: P = 0.836, SMD: P = 0.260).","['Patients from a trial comparing once', 'patients with limited stage small cell lung cancer (LS SCLC', 'Median age was 64\xa0years, 18% had performance status 2, and 38% had stage III', 'patients with limited stage small cell lung cancer']","['TRT', 'cisplatin per kilogram LBM', 'platinum-etoposide chemotherapy and thoracic radiotherapy (TRT', 'cisplatin', 'standard chemoradiotherapy', 'daily hypofractionated with twice daily hyperfractionated TRT']","['skeletal muscle index (SMI), skeletal muscle radiodensity (SMD), and LBM', 'severe toxicity', 'survival', 'survival, and toxicity', 'median overall survival', 'haematological toxicity and neutropenic infections', 'Median LBM', 'Grade 3-4 toxicity', 'risk of grade 3-4 haematological toxicity', 'neutropenic infections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0278725', 'cui_str': 'Small cell lung cancer limited stage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1167779', 'cui_str': 'Neutropenic infection'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.376505,"There were no significant associations between survival and any of the muscle measures in the univariable analyses (SMI: P = 0.906, SMD: P = 0.829) or in multivariable analyses adjusting for baseline characteristics (SMI: P = 0.836, SMD: P = 0.260).","[{'ForeName': 'Tarje Onsøien', 'Initials': 'TO', 'LastName': 'Halvorsen', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, 7491, Norway.'}, {'ForeName': 'Christine Damgaard', 'Initials': 'CD', 'LastName': 'Valan', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, 7491, Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Slaaen', 'Affiliation': 'Department of Internal Medicine, Innlandet Hospital Trust, Hamar, Norway.'}, {'ForeName': 'Bjørn Henning', 'Initials': 'BH', 'LastName': 'Grønberg', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, 7491, Norway.'}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12583']
1224,32696183,Letter to the editor: Is it time to abandon episiotomy use? A randomized controlled trial (EPITRIAL).,,2020,,[],[],[],[],[],[],,0.0788517,,"[{'ForeName': 'Melania Maria', 'Initials': 'MM', 'LastName': 'Amorim', 'Affiliation': 'Instituto de Medicina Integral Prof. Fernando Figueira, Recife, Brazil. profmelania.amorim@gmail.com.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Delgado', 'Affiliation': 'Instituto de Medicina Integral Prof. Fernando Figueira, Recife, Brazil.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Katz', 'Affiliation': 'Instituto de Medicina Integral Prof. Fernando Figueira, Recife, Brazil.'}]",International urogynecology journal,['10.1007/s00192-020-04421-2']
1225,32702259,Re: Home-Based 'Exergaming' Was Safe and Significantly Improved 6-Min Walking Distance in Patients with Prostate Cancer: A Single-Blinded Randomised Controlled Trial.,,2020,,['Patients with Prostate Cancer'],[],['6-Min Walking Distance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",[],"[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",,0.10883,,"[{'ForeName': 'Tomas L', 'Initials': 'TL', 'LastName': 'Griebling', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001207.03']
1226,32701652,Intradural artery dilation during experimentally induced migraine attacks.,"The middle meningeal artery is a proposed surrogate marker for activation of trigeminal nociceptors during migraine. Previous studies focused on the extracranial part of the artery; hence, vasoreactivity in the intradural arteries during migraine is unknown. Thirty-four patients with migraine without aura were given sildenafil on one day and calcitonin gene-related peptide on another in double-blind crossover fashion. Patients were scanned with 3.0 T MR angiography before drug administration and again 6 hours later during induced attacks of migraine. We measured circumference of the intradural segment of the middle meningeal artery before and during induced migraine attacks. The middle cerebral and superficial temporal arteries were also examined. Fourteen patients had attacks during the second scan after both study drugs and 11 had a migraine after either one or the other, resulting in a total of 39 attacks included in the final analysis. Mean circumference of the intradural middle meningeal artery at baseline was 3.18 mm with an increase of 0.11 mm during attacks (P = 0.005), corresponding to a relative dilation of 3.6% [95% CI: 1.4%-5.7%]. Middle cerebral artery dilated by 9.4% [95% CI: 7.1%-11.7%] and superficial temporal artery by 2.3% [95% CI: 0.2%-4.4%]. Our study shows that the intradural middle meningeal artery and the middle cerebral artery are dilated during migraine induced by calcitonin gene-related peptide as well as sildenafil. We propose that intradural vasculature is affected by migraine-driven activation of trigeminal afferents during migraine attacks.",2020,Middle cerebral artery dilated by 9.4 % [95% CI: 7.1 to 11.7 %] and superficial temporal artery by 2.3 % [95% CI: 0.2 to 4.4 %].Our,"['Thirty-four patients with migraine without aura', 'Fourteen patients had attacks during the second scan after both study drugs and 11 had a migraine after either one or the other, resulting in a total of 39 attacks included in the final analysis']","['calcitonin gene-related peptide', 'sildenafil']","['Mean circumference of the intradural middle meningeal artery', 'superficial temporal artery', 'Middle cerebral artery dilated']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338480', 'cui_str': 'Migraine without aura'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0226147', 'cui_str': 'Structure of middle meningeal artery'}, {'cui': 'C0226130', 'cui_str': 'Structure of superficial temporal artery'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0700124', 'cui_str': 'Ectatic'}]",,0.0474213,Middle cerebral artery dilated by 9.4 % [95% CI: 7.1 to 11.7 %] and superficial temporal artery by 2.3 % [95% CI: 0.2 to 4.4 %].Our,"[{'ForeName': 'Casper E', 'Initials': 'CE', 'LastName': 'Christensen', 'Affiliation': 'Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Samaira', 'Initials': 'S', 'LastName': 'Younis', 'Affiliation': 'Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Lindberg', 'Affiliation': 'Functional Imaging Unit, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'de Koning', 'Affiliation': 'Division of Image Processing, Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tolnai', 'Affiliation': 'Department of Radiology, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Olaf B', 'Initials': 'OB', 'LastName': 'Paulson', 'Affiliation': 'Neurobiology Research Unit, Department of Neurology, Rigshospitalet Blegdamsvej, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henrik B W', 'Initials': 'HBW', 'LastName': 'Larsson', 'Affiliation': 'Functional Imaging Unit, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Faisal M', 'Initials': 'FM', 'LastName': 'Amin', 'Affiliation': 'Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",Pain,['10.1097/j.pain.0000000000002008']
1227,32716241,"Re: Prostate-Specific Membrane Antigen PET-CT in Patients with High-Risk Prostate Cancer before Curative-Intent Surgery or Radiotherapy (proPSMA): A Prospective, Randomised, Multicentre Study.",,2020,,['Patients with High-Risk Prostate Cancer before Curative-Intent Surgery or Radiotherapy (proPSMA'],['Re: Prostate-Specific Membrane Antigen PET-CT'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}]",[],,0.0402414,,"[{'ForeName': 'Samir S', 'Initials': 'SS', 'LastName': 'Taneja', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001220.01']
1228,32716270,Re: Prospective Randomized Trial Comparing the Safety and Clarity of Water versus Saline Irrigant in Ureteroscopy.,,2020,,[],['Water versus Saline Irrigant'],[],[],"[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}]",[],,0.0542995,,"[{'ForeName': 'Dean G', 'Initials': 'DG', 'LastName': 'Assimos', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001217.04']
1229,32721104,Improvement in inner retinal function in glaucoma with nicotinamide (vitamin B3) supplementation: A crossover randomized clinical trial.,"IMPORTANCE


Retinal ganglion cells endure significant metabolic stress in glaucoma but maintain capacity to recover function. Nicotinamide, a precursor of NAD +  , is low in serum of glaucoma patients and its supplementation provides robust protection of retinal ganglion cells in preclinical models. However, the potential of nicotinamide in human glaucoma is unknown.
BACKGROUND


To examine the effects of nicotinamide on inner retinal function in glaucoma, in participants receiving concurrent glaucoma therapy.
DESIGN


Crossover, double-masked, randomized clinical trial. Participants recruited from two tertiary care centres.
PARTICIPANTS


Fifty-seven participants, diagnosed and treated for glaucoma.
METHODS


Participants received oral placebo or nicotinamide and reviewed six-weekly. Participants commenced 6 weeks of 1.5 g/day then 6 weeks of 3.0 g/day followed by crossover without washout. Visual function measured using electroretinography and perimetry.
MAIN OUTCOME MEASURES


Change in inner retinal function, determined by photopic negative response (PhNR) parameters: saturated PhNR amplitude (Vmax), ratio of PhNR/b-wave amplitude (Vmax ratio).
RESULTS


PhNR Vmax improved beyond 95% coefficient of repeatability in 23% of participants following nicotinamide vs 9% on placebo. Overall, Vmax improved by 14.8% [95% CI: 2.8%, 26.9%], (P = .02) on nicotinamide and 5.2% [-4.2%, 14.6%], (P = .27) on placebo. Vmax ratio improved by 12.6% [5.0%, 20.2%], (P = .002) following nicotinamide, 3.6% [-3.4%, 10.5%], (P = .30) on placebo. A trend for improved visual field mean deviation was observed with 27% improving ≥1 dB on nicotinamide and fewer deteriorating (4%) compared to placebo (P = .02).
CONCLUSIONS


Nicotinamide supplementation can improve inner retinal function in glaucoma. Further studies underway to elucidate the effects of long-term nicotinamide supplementation.",2020,"Overall, Vmax improved by 14.8% [95% CI: 2.8%, 26.9%], (P = .02) on nicotinamide and 5.2% [-4.2%, 14.6%], (P = .27) on placebo.","['Fifty-seven participants, diagnosed and treated for glaucoma', 'Participants recruited from two tertiary care centres', 'participants receiving concurrent glaucoma therapy']","['oral placebo or nicotinamide', 'Nicotinamide supplementation', 'nicotinamide (vitamin B3) supplementation', 'nicotinamide', 'placebo']","['Overall, Vmax', 'Change in inner retinal function, determined by photopic negative response (PhNR) parameters: saturated PhNR amplitude (Vmax), ratio of PhNR/b-wave amplitude (Vmax ratio', 'Vmax ratio', 'visual field mean deviation', 'Visual function', 'PhNR Vmax improved beyond 95% coefficient of repeatability']","[{'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C1828170', 'cui_str': 'Mean deviation'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",57.0,0.649578,"Overall, Vmax improved by 14.8% [95% CI: 2.8%, 26.9%], (P = .02) on nicotinamide and 5.2% [-4.2%, 14.6%], (P = .27) on placebo.","[{'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Hui', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Pete A', 'Initials': 'PA', 'LastName': 'Williams', 'Affiliation': 'Department of Clinical Neuroscience, Division of Eye and Vision, St. Erik Eye Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Myra B', 'Initials': 'MB', 'LastName': 'McGuinness', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Hadoux', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Casson', 'Affiliation': 'Ophthalmic Research Laboratories, Discipline of Ophthalmology and Visual Sciences, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Coote', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Trounce', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Martin', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van Wijngaarden', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Crowston', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}]",Clinical & experimental ophthalmology,['10.1111/ceo.13818']
1230,32721845,Implementation of magnesium sulphate as an adjunct to multimodal analgesic approach for perioperative pain control in lumbar laminectomy surgery: A randomized placebo-controlled clinical trial.,"OBJECTIVE


To investigate the effect of systemic intraoperative administration of magnesium sulphate when used in the context of a multimodal pain management plan on analgesics consumption and pain scores, and perioperative outcomes after lumbar laminectomy surgery.
METHODS


Seventy-four patients undergoing lumbar laminectomy were enrolled in this randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to receive magnesium (20 mg/kg iv given as bolus before anesthesia induction followed by 20 mg/kg/h civ until surgery completion) or saline. Hemodynamic variables and desflurane consumption were noted at predefined time-intervals intraoperatively. Primary outcome was postoperative cumulative analgesic consumption over 24 h, while pain intensity (assessed by Visual Analogue Scale [VAS] at 1, 2, 4, 6 and 24 h), intraoperative hemodynamics and opioid requirements, recovery profile, time to first analgesic request, and adverse effects constituted secondary end-points.
RESULTS


Demographics, surgery duration, desflurane requirements, and recovery profile were comparable between groups. Magnesium attenuated hemodynamic response during incision and emergence from anesthesia. Postoperative analgesics consumption in morphine iv equivalents (mean difference -9.24 [95 %CI -13.31, -5.17] mg; p = 0.001) and VAS scores at all-time points of assessment were lower in magnesium group; this effect peaked at 4 h (mean difference -2.15 [95 %CI -3.21,-1.09; p = 0.001]. Magnesium reduced intraoperative remifentanil consumption and prolonged the time-interval to first rescue analgesia (p < 0.01). No notable adverse effects were recorded.
CONCLUSION


It occurs that magnesium infusion during lumbar laminectomy surgery potentiates perioperative analgesia and reduces analgesic requirements up to 24 h postoperatively. No profound adverse effect on either intraoperative hemodynamics or any other clinically relevant endpoints becomes evident.",2020,Magnesium reduced intraoperative remifentanil consumption and prolonged the time-interval to first rescue analgesia (p < 0.01).,"['lumbar laminectomy surgery', 'Seventy-four patients undergoing lumbar laminectomy']","['Magnesium', 'placebo', 'magnesium (20\u202fmg/kg iv given as bolus before anesthesia induction followed by 20\u202fmg/kg/h civ until surgery completion) or saline', 'magnesium sulphate', 'magnesium', 'morphine']","['adverse effects', 'time-interval to first rescue analgesia', 'intraoperative remifentanil consumption', 'analgesics consumption and pain scores, and perioperative outcomes', 'postoperative cumulative analgesic consumption over 24\u202fh, while pain intensity (assessed by Visual Analogue Scale [VAS] at 1, 2, 4, 6 and 24\u202fh), intraoperative hemodynamics and opioid requirements, recovery profile, time to first analgesic request, and adverse effects constituted secondary end-points', 'analgesic requirements', 'hemodynamic response', 'Postoperative analgesics consumption', 'Hemodynamic variables and desflurane consumption', 'Demographics, surgery duration, desflurane requirements, and recovery profile', 'VAS scores']","[{'cui': 'C1112614', 'cui_str': 'Lumbar laminectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1320755', 'cui_str': 'mg/kg/hr'}, {'cui': 'C0022326', 'cui_str': 'Ivory Coast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",74.0,0.791883,Magnesium reduced intraoperative remifentanil consumption and prolonged the time-interval to first rescue analgesia (p < 0.01).,"[{'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Tsaousi', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: tsaousig@otenet.gr.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Nikopoulou', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: anastasian1991@windowslive.com.'}, {'ForeName': 'Ioakeim', 'Initials': 'I', 'LastName': 'Pezikoglou', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: makispez@gmail.com.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Birba', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: bsbvasso@yahoo.gr.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Grosomanidis', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: grosoman@otenet.gr.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106091']
1231,32734366,"A Multicentre, Randomised Clinical Trial to Compare a Topical Nitrizinc ®  Complex Solution Versus Cryotherapy for the Treatment of Anogenital Warts.","INTRODUCTION


Anogenital warts (AGW) are a relevant clinical issue in the field of sexually transmitted disease, and to date no treatment provides a satisfactory clearance rate. Treatment can be both medical and surgical, and be provided by a healthcare provider or by the patient. Cryotherapy (CRYO) is among the most common treatments for AGW. Nitrizinc® Complex solution (NZCS) is a solution containing organic acids, nitric acid and zinc and copper salts that is applied topically to warts, producing mummification of the damaged tissue. It is considered to be an effective and well-tolerated treatment for genital and common warts. The aim of our study was to compare NZCS to CRYO in the treatment of AGW.
METHODS


We performed a prospective, multicentre, single-blind, randomised, superiority clinical study involving 120 patients, aged 18-55 years, diagnosed with a first episode of AGW, with each patient having from three to ten AGW. The patients were treated either with NZCS or CRYO for a maximum of four treatments. Primary endpoints were: (1) comparison of the clinical efficacy of CRYO and NZCS, based on response to treatment (clearance of AGW) within four treatment sessions; and (2) tolerability, assessed via a short questionnaire at the end of each treatment session. Secondary endpoints were: (1) number of treatments needed for clearance; and (2) recurrence at 1 and 3e months after confirmed clearance. The results were analysed on an intention-to-treat basis.
RESULTS


A complete response was achieved in 89.7% of the NZCS group and in 75.4% of the CRYO group (p = 0.0443). NZCS was found to be better tolerated. There was no difference between the NZCS and CRYO treatment arms in the number of sessions needed to clear the lesions. Recurrence occurred after 1 month in 18.4% of the NZCS group and 38.1% of the CRYO group (p = 0.0356), and after 3 months in 25 and 40.6% of these groups, respectively (p = 0.1479).
CONCLUSIONS


Nitrizinc® Complex solution can be considered to be as effective as CRYO for the treatment of small (< 5 mm) external AGW, with a better tolerability profile and lower rate of recurrence.
TRIAL REGISTRATION


ISRCTN identifier, ISRCTN36102369.",2020,"Recurrence occurred after 1 month in 18.4% of the NZCS group and 38.1% of the CRYO group (p = 0.0356), and after 3 months in 25 and 40.6% of these groups, respectively (p = 0.1479).
","['120 patients, aged 18-55\xa0years, diagnosed with a first episode of AGW, with each patient having from three to ten AGW', 'Anogenital Warts']","['Nitrizinc® Complex solution (NZCS', 'Topical Nitrizinc ®  Complex Solution Versus Cryotherapy', 'Cryotherapy (CRYO', 'NZCS or CRYO', 'NZCS']","['number of sessions needed to clear the lesions', 'tolerated', 'Recurrence', 'clinical efficacy of CRYO and NZCS, based on response to treatment (clearance of AGW) within four treatment sessions; and (2) tolerability, assessed via a short questionnaire', '1) number of treatments needed for clearance; and (2) recurrence']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0009663', 'cui_str': 'Genital warts'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0009663', 'cui_str': 'Genital warts'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}]",120.0,0.0861442,"Recurrence occurred after 1 month in 18.4% of the NZCS group and 38.1% of the CRYO group (p = 0.0356), and after 3 months in 25 and 40.6% of these groups, respectively (p = 0.1479).
","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pontini', 'Affiliation': ""Unit of Dermatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Pace 9, 20122, Milan, Italy. pontini.p@gmail.com.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Mastorino', 'Affiliation': 'Dermatology Clinic, Department of Medical Sciences, Azienda Ospedaliera Universitaria Città della Salute e della Scienza-University of Turin, Turin, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Gaspari', 'Affiliation': ""Unit of Dermatology, Head and Neck Department, Sant'Orsola Malpighi University Hospital, Bologna, Italy.""}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Granger', 'Affiliation': 'Innovation and Development, ISDIN, Barcelona, Spain.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ramoni', 'Affiliation': ""Unit of Dermatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Pace 9, 20122, Milan, Italy.""}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Delmonte', 'Affiliation': 'Dermatology Clinic, Department of Medical Sciences, Azienda Ospedaliera Universitaria Città della Salute e della Scienza-University of Turin, Turin, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Evangelista', 'Affiliation': ""Unit of Dermatology, Head and Neck Department, Sant'Orsola Malpighi University Hospital, Bologna, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cusini', 'Affiliation': ""Unit of Dermatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Pace 9, 20122, Milan, Italy.""}]",Dermatology and therapy,['10.1007/s13555-020-00430-7']
1232,32731786,Improving cognitive and physical function through 12-weeks of resistance training in older adults: Randomized controlled trial.,"We performed a randomized, controlled trial to analyse the effects of resistance training (RT) on cognitive and physical function among older adults. Fifty participants (mean age 67 years, ~60% woman) were randomly assigned to an RT program or a control group. Participants allocated to RT performed three sets of 10-15RM in nine exercises, three times per week, for 12-weeks. Control group did not perform any exercise. Variables included cognitive (global and executive function) and physical function (gait, mobility and strength) outcomes. At completion of the intervention, RT was shown to have significantly mitigated the drop in selective attention and conflict resolution performance (Stroop test: -494.6; 95%CI: -883.1; -106.1) and promoted a significant improvement in working memory (digit span forward: -0.6; 95%CI: -1.0; -0.1 and forward minus backward: -0.9; 95% CI: -1.6; -0.2) and verbal fluency (animal naming: +1.4, 95%CI 0.3, 2.5). No significant between-group differences were observed for other cognitive outcomes. Regarding physical function, at completion of the intervention, the RT group demonstrated improved fast-pace gait performance (-0.3; 95% CI: -0.6; -0.0) and 1-RM (+21.4 kg; 95%CI: 16.6; 26.2). No significant between-group differences were observed for other mobility-related outcomes. In conclusion, RT improves cognitive and physical function of older adults.",2020,"At completion of the intervention, RT was shown to have significantly mitigated the drop in selective attention and conflict resolution performance (Stroop test:","['Fifty participants (mean age 67 years, ~60% woman', 'older adults']","['RT program or a control group', 'RT', 'resistance training (RT', 'resistance training', '95%CI']","['verbal fluency', 'working memory (digit span forward', 'cognitive and physical function', 'selective attention and conflict resolution performance (Stroop test', 'cognitive outcomes', 'fast-pace gait performance', 'cognitive (global and executive function) and physical function (gait, mobility and strength) outcomes']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention'}, {'cui': 'C0150526', 'cui_str': 'Conflict Resolution'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",50.0,0.0643416,"At completion of the intervention, RT was shown to have significantly mitigated the drop in selective attention and conflict resolution performance (Stroop test:","[{'ForeName': 'Paulo Ricardo Pereira Dos', 'Initials': 'PRPD', 'LastName': 'Santos', 'Affiliation': 'Clinical Exercise Lab (LABEC), Physical Education Department, Federal University of Vale Do São Francisco (UNIVASF) , Petrolina, Brazil.'}, {'ForeName': 'Bruno Remígio', 'Initials': 'BR', 'LastName': 'Cavalcante', 'Affiliation': 'Clinical Exercise Lab (LABEC), Physical Education Department, Federal University of Vale Do São Francisco (UNIVASF) , Petrolina, Brazil.'}, {'ForeName': 'Andreya Karolyne Dos Santos', 'Initials': 'AKDS', 'LastName': 'Vieira', 'Affiliation': 'Clinical Exercise Lab (LABEC), Physical Education Department, Federal University of Vale Do São Francisco (UNIVASF) , Petrolina, Brazil.'}, {'ForeName': 'Marcos Duarte', 'Initials': 'MD', 'LastName': 'Guimarães', 'Affiliation': 'Department of Medicine, Federal University of Vale Do São Francisco (UNIVASF), Petrolina , Pernambuco, Brazil.'}, {'ForeName': 'Antônio Marconi', 'Initials': 'AM', 'LastName': 'Leandro Da Silva', 'Affiliation': 'Department of Medicine, Federal University of Vale Do São Francisco (UNIVASF), Petrolina , Pernambuco, Brazil.'}, {'ForeName': 'Anderson Da Costa', 'Initials': 'ADC', 'LastName': 'Armstrong', 'Affiliation': 'Department of Medicine, Federal University of Vale Do São Francisco (UNIVASF), Petrolina , Pernambuco, Brazil.'}, {'ForeName': 'Rodrigo Gustavo Da Silva', 'Initials': 'RGDS', 'LastName': 'Carvalho', 'Affiliation': 'Physical Education Department, Federal University of Vale Do São Francisco (UNIVASF), Petrolina , Pernambuco, Brazil.'}, {'ForeName': 'Ferdinando Oliveira De', 'Initials': 'FO', 'LastName': 'Carvalho', 'Affiliation': 'Physical Education Department, Federal University of Vale Do São Francisco (UNIVASF), Petrolina , Pernambuco, Brazil.'}, {'ForeName': 'Mariana Ferreira De', 'Initials': 'MF', 'LastName': 'Souza', 'Affiliation': 'Clinical Exercise Lab (LABEC), Physical Education Department, Federal University of Vale Do São Francisco (UNIVASF) , Petrolina, Brazil.'}]",Journal of sports sciences,['10.1080/02640414.2020.1763740']
1233,32702255,"Re: Long-Term Effect of Community-Based Continence Promotion on Urinary Symptoms, Falls and Health Active Life Expectance among Older Women: Cluster Randomised Trial.",,2020,,['Older Women'],['Community-Based Continence Promotion'],"['Urinary Symptoms, Falls and Health Active Life Expectance']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",,0.0837289,,"[{'ForeName': 'Tomas L', 'Initials': 'TL', 'LastName': 'Griebling', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001207.01']
1234,32702256,"Re: Testosterone for Androgen Deficiency-Like Symptoms in Men without Pathologic Hypogonadism: A Randomized, Placebo-Controlled Cross-Over with Masked Choice Extension Clinical Trial.",,2020,,['Men without Pathologic Hypogonadism'],"['Re: Testosterone', 'Placebo']",[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0020619', 'cui_str': 'Hypogonadism'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.745346,,"[{'ForeName': 'Tomas L', 'Initials': 'TL', 'LastName': 'Griebling', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001207.04']
1235,32702258,"Re: A Group-Based Yoga Program for Urinary Incontinence in Ambulatory Women: Feasibility, Tolerability, and Change in Incontinence Frequency over 3 Months in a Single-Center Randomized Trial.",,2020,,['Ambulatory Women'],['Re: A Group-Based Yoga Program'],[],"[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0157535,,"[{'ForeName': 'Tomas L', 'Initials': 'TL', 'LastName': 'Griebling', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001207.02']
1236,32706184,"The use of collagen porcine dermal matrix and connective tissue graft with modified coronally advanced tunnel technique in the treatment of multiple adjacent type I gingival recessions: A randomized, controlled clinical trial.","OBJECTIVE


To assess the clinical efficacy and esthetic outcome of porcine-derived dermal collagen matrix in comparison with connective tissue graft in the treatment of multiple adjacent gingival recessions (MAGR), 6 and 12 months after the surgery.
MATERIALS AND METHODS


Twenty patients with bilateral type I MAGR were treated randomly with porcine-derived dermal collagen matrix (test site) or connective tissue graft (control site) in combination with a modified coronally advanced tunnel technique. The primary objectives were to evaluate the mean and complete root coverage. The secondary objectives were to assess keratinized tissue width, gingival thickness gain, and root coverage esthetic score.
RESULTS


Six and 12 months postoperatively, both groups achieved significant improvements in all clinical parameters compared to baseline, with no statistically significant differences between the groups. Mean root coverage change (Δ12m - 6 m) was statistically significant between the groups in favor of connective tissue graft, and twice as many patients exhibited a complete coverage of all recessions in the control group than the test group.
CONCLUSION


The porcine-derived dermal collagen matrix combined with a modified coronally advanced tunnel technique resulted in satisfactory clinical and esthetic outcomes, which were similar to connective tissue graft.
CLINICAL SIGNIFICANCE


Porcine-derived dermal collagen matrix (XDM) may be proposed as a substitute for connective tissue graft in multiple adjacent recession treatment due to successful root coverage, a significant increase of gingival thickness, and high esthetic outcomes. The clinical benefits for the use of XDM could be: (a) second surgical wound avoidance, (b) patient discomfort decrease, and (c) lower complications' rate.",2020,"Mean root coverage change (Δ12m - 6 m) was statistically significant between the groups in favor of connective tissue graft, and twice as many patients exhibited a complete coverage of all recessions in the control group than the test group.
","['multiple adjacent type I gingival recessions', 'multiple adjacent gingival recessions (MAGR), 6 and 12\u2009months after the surgery', 'Twenty patients with bilateral type I MAGR']","['porcine-derived dermal collagen matrix (test site) or connective tissue graft (control site) in combination with a modified coronally advanced tunnel technique', 'porcine-derived dermal collagen matrix', 'collagen porcine dermal matrix and connective tissue graft with modified coronally advanced tunnel technique', 'Porcine-derived dermal collagen matrix (XDM']","['mean and complete root coverage', 'keratinized tissue width, gingival thickness gain, and root coverage esthetic score', 'satisfactory clinical and esthetic outcomes', 'Mean root coverage change']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3486131', 'cui_str': 'Pork collagen preparation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",20.0,0.0471807,"Mean root coverage change (Δ12m - 6 m) was statistically significant between the groups in favor of connective tissue graft, and twice as many patients exhibited a complete coverage of all recessions in the control group than the test group.
","[{'ForeName': 'Dragana L', 'Initials': 'DL', 'LastName': 'Rakasevic', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Iva Z', 'Initials': 'IZ', 'LastName': 'Milinkovic', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Sasa M', 'Initials': 'SM', 'LastName': 'Jankovic', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Ivan A', 'Initials': 'IA', 'LastName': 'Soldatovic', 'Affiliation': 'Institute for Biostatistics, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Zoran M', 'Initials': 'ZM', 'LastName': 'Aleksic', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Natasa S', 'Initials': 'NS', 'LastName': 'Nikolic-Jakoba', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Belgrade, Belgrade, Serbia.'}]",Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.],['10.1111/jerd.12624']
1237,32707325,"Eclipse stemless shoulder prosthesis vs. Univers II shoulder prosthesis: a multicenter, prospective randomized controlled trial.","BACKGROUND


Total shoulder arthroplasty is an accepted treatment for glenohumeral osteoarthritis. The Arthrex Eclipse shoulder prosthesis is a stemless, canal-sparing humeral prosthesis with bone ingrowth capacity on the trunnion, as well as through the fenestrated hollow screw, that provides both diaphyseal and metaphyseal load sharing and fixation.
METHODS


Between 2013 and 2018, 16 sites in the United States enrolled 327 patients (Eclipse in 237 and Arthrex Univers II in 90). All patients had glenohumeral arthritis refractory to nonsurgical care. Strict exclusion criteria were applied to avoid confounding factors such as severe patient comorbidities, arthritis not consistent with osteoarthritis, and medical or prior surgical treatments that may have affected outcomes. Patients were randomized to the Eclipse or Univers II group via block randomization.
RESULTS


In total, 149 Eclipse and 76 Univers II patients reached 2-year follow-up (139 Eclipse patients [93.3%] and 68 Univers II patients [89.5%] had complete data). The success rate using the Composite Clinical Success score was 95% in the Eclipse group vs. 89.7% in the Univers II group. No patient exhibited radiographic evidence of substantial humeral radiolucency, humeral migration, or subsidence at any point. Reoperations were performed in 7 patients (3.2%) in the Eclipse group and 3 (3.8%) in the Univers II group.
CONCLUSION


The Arthrex Eclipse shoulder prosthesis is a safe and effective humeral implant for patients with glenohumeral arthritis at 2-year follow-up, with no differences in outcomes compared with the Univers II shoulder prosthesis.",2020,"The Arthrex Eclipse shoulder prosthesis is a safe and effective humeral implant for patients with glenohumeral arthritis at two-year follow-up with no differences in outcomes when compared to the Univers II.
","['16 sites in the United States enrolled 327 patients (237 Eclipse, 90 Univers II) between 2013-2019', 'glenohumeral osteoarthritis', 'All patients had glenohumeral arthritis refractory to non-surgical care']",['Eclipse Stemless Shoulder Prosthesis versus Univers II Shoulder Prosthesis'],['success rate using the composite clinical success (CCS) score'],"[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C1961833', 'cui_str': 'Artificial Shoulder Joint'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",327.0,0.112073,"The Arthrex Eclipse shoulder prosthesis is a safe and effective humeral implant for patients with glenohumeral arthritis at two-year follow-up with no differences in outcomes when compared to the Univers II.
","[{'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Romeo', 'Affiliation': 'Department of Orthopaedic Surgery, Rothman Orthopaedic Institute-New York, New York, NY, USA.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Erickson', 'Affiliation': 'Department of Orthopaedic Surgery, Rothman Orthopaedic Institute-New York, New York, NY, USA. Electronic address: brandon.j.erickson@gmail.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Costouros', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Long', 'Affiliation': 'Bone and Joint Center, Columbus, OH, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Klassen', 'Affiliation': 'Essentia Health Duluth, Duluth, MN, USA.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Araghi', 'Affiliation': 'Banner Research, Sun City, AZ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Banner Research, Sun City, AZ, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Setter', 'Affiliation': 'The Research Foundation for The State University of New York, Syracuse, NY, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Port', 'Affiliation': 'Altoona Regional Health System, Altoona, PA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tyndall', 'Affiliation': 'Altoona Regional Health System, Altoona, PA, USA.'}, {'ForeName': 'Nikhil N', 'Initials': 'NN', 'LastName': 'Verma', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Sears', 'Affiliation': 'Rose Medical Center, Denver, CO, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Brandon', 'Affiliation': 'Peninsula Regional Medical Center, Salisbury, MD, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': 'Ellis and Badenhausen Orthopedics, Louisville, KY, USA.'}, {'ForeName': 'Earl', 'Initials': 'E', 'LastName': 'McFadden', 'Affiliation': 'Palmetto Health Orthopedics, Columbia, SC, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Patterson', 'Affiliation': 'Excelsior Orthopedics, Buffalo, NY, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Stein', 'Affiliation': 'Union Memorial Hospital, Baltimore, MD, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Cohen', 'Affiliation': 'Adena Regional Medical Center, Chillicothe, OH, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Abboud', 'Affiliation': 'Department of Orthopaedic Surgery, Rothman Orthopaedic Institute, Philadelphia, PA, USA.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.07.004']
1238,32716061,Impact of different surgical protocols on dimensional changes of free soft tissue autografts. A randomized controlled trial.,"BACKGROUND


To determine if there is a difference in the amount of shrinkage during healing of free soft tissue autografts (FSTAs) using different surgical techniques-suturing the vestibular flap margin apically to the base of the recipient bed versus leaving the flap margin free and unsutured.
METHODS


Twenty-eight patients with mucogingival defects requiring FSTAs were recruited and enrolled in the study. Patients were randomized into test and control groups (14 per group) and received ≥1 FSTAs on non-molar mandibular teeth. In the test group the mucosal flap margin was sutured apically to the periosteum at the base of the graft; whereas, the mucosal flap margin in the control group was left free. Graft dimensional measurements were taken at time of surgery, then at 1, 3, and 6 months post-surgery.
RESULTS


Thirty-five grafts were performed (15 test, 20 control). All FSTAs experienced vertical shrinkage after 6 months, but there was no significant difference (P = 0.51) in the mean amount of shrinkage after 6 months between the test (23.20% ± 20.88%) and control (21.10% ± 21.88%) groups. There was significantly greater horizontal shrinkage in the test (loss of 7.59% ± 10.20%) compared with the control (small gain of 0.32% ± 4.20%) group (P = 0.01).
CONCLUSIONS


The findings suggest that there is similar vertical shrinkage when performing FSTA surgery when the mucosal flap margin is left free and unsutured when compared with leaving the flap margin free.",2020,"All FSTAs experienced vertical shrinkage after 6 months, but there was no significant difference (P = 0.51) in the mean amount of shrinkage after 6 months between the test (23.20 ± 20.88%) and control (21.10 ± 21.88%) groups.",['Twenty-eight patients with mucogingival defects requiring FSTAs were recruited and enrolled in the study'],['one or more FSTAs on non-molar mandibular teeth'],"['dimensional changes of free soft tissue autografts', 'mean amount of shrinkage', 'vertical shrinkage', 'mucosal flap margin', 'horizontal shrinkage']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0227029', 'cui_str': 'Structure of mandibular teeth'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0729268', 'cui_str': 'Mucosal flap'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}]",35.0,0.0387735,"All FSTAs experienced vertical shrinkage after 6 months, but there was no significant difference (P = 0.51) in the mean amount of shrinkage after 6 months between the test (23.20 ± 20.88%) and control (21.10 ± 21.88%) groups.","[{'ForeName': 'Akemi', 'Initials': 'A', 'LastName': 'Arzouman', 'Affiliation': 'Department of Periodontics, UT Health San Antonio School of Dentistry, San Antonio, TX.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Deas', 'Affiliation': 'Department of Periodontics, UT Health San Antonio School of Dentistry, San Antonio, TX.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Mills', 'Affiliation': 'Department of Periodontics, UT Health San Antonio School of Dentistry, San Antonio, TX.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Huynh-Ba', 'Affiliation': 'Department of Periodontics, UT Health San Antonio School of Dentistry, San Antonio, TX.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Prihoda', 'Affiliation': 'Department of Pathology, UT Health San Antonio, San Antonio, TX.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Mealey', 'Affiliation': 'Department of Periodontics, UT Health San Antonio School of Dentistry, San Antonio, TX.'}]",Journal of periodontology,['10.1002/JPER.20-0033']
1239,32719963,In reply: Letter to the editor: Is it time to abandon episiotomy use? A randomized controlled trial (epitrial).,,2020,,[],[],[],[],[],[],,0.0830738,,"[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Sagi-Dain', 'Affiliation': 'Department of Obstetrics and Gynecology, Carmel Medical Center, 7 Michal St., Haifa, Israel. lena2303@gmail.com.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Kreinin-Bleicher', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Bahous', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Shlomi', 'Initials': 'S', 'LastName': 'Sagi', 'Affiliation': 'Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}]",International urogynecology journal,['10.1007/s00192-020-04453-8']
1240,32721437,"Budesonide Orodispersible Tablets Maintain Remission in a Randomized, Placebo-Controlled Trial of Patients With Eosinophilic Esophagitis.","BACKGROUND & AIMS


Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder. Swallowed topical-acting corticosteroids are effective in bringing active EoE into remission. However, it is not clear whether these drugs are effective for long-term maintenance of remission.
METHODS


We performed a double-blind trial to compare the efficacy and safety of 2 dosages of a budesonide orodispersible tablet (BOT) vs placebo in maintaining remission of EoE. Maintenance of remission was defined as absence of clinical and histologic relapse and no premature withdrawal for any reason. Two hundred and four adults with EoE in clinical and histologic remission, from 29 European study sites, were randomly assigned to groups given BOT 0.5 mg twice daily (n = 68), BOT 1.0 mg twice daily (n = 68), or placebo twice daily (n = 68) for up to 48 weeks.
RESULTS


At end of treatment, 73.5% of patients receiving BOT 0.5 mg twice daily and 75% receiving BOT 1.0 mg twice daily were in persistent remission compared with 4.4% of patients in the placebo group (P < .001 for both comparisons of BOT with placebo). Median time to relapse in the placebo group was 87 days. The frequency of adverse events was similar in the BOT and placebo groups. Morning serum levels of cortisol were in the normal range at baseline and did not significantly change during treatment. Four patients receiving BOT developed asymptomatic, low serum levels of cortisol. Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment.
CONCLUSIONS


In a phase 3 trial, up to 48 weeks of treatment with BOT (0.5 mg or 1.0 mg twice daily) was superior to placebo in maintaining remission of EoE. Both dosages were equally effective and well tolerated. EudraCT number; 2014-001485-99; ClinicalTrials.gov number, NCT02434029.",2020,"Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment.
","['Patients With Eosinophilic Esophagitis', 'Two hundred and four adults with EoE in clinical and histologic remission, from 29 European study sites']","['budesonide orodispersible tablet (BOT) vs placebo', 'Placebo', 'Budesonide Orodispersible Tablets', 'Swallowed topical-acting corticosteroids', 'BOT 0.5 mg twice daily (n=68), BOT 1.0 mg twice daily (n=68), or placebo', 'BOT', 'placebo']","['Median time to relapse', 'Morning serum levels of cortisol', 'asymptomatic, low serum levels of cortisol', 'frequency of adverse events', 'efficacy and safety', 'effective and well tolerated', 'Clinically manifested candidiasis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341106', 'cui_str': 'Eosinophilic esophagitis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C2960508', 'cui_str': 'Orodispersible tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0006840', 'cui_str': 'Candidiasis'}]",204.0,0.627341,"Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment.
","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Straumann', 'Affiliation': 'Swiss Eosinophilic Esophagitis Research Group, Olten, Switzerland; Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland. Electronic address: alex.straumann@hin.ch.'}, {'ForeName': 'Alfredo J', 'Initials': 'AJ', 'LastName': 'Lucendo', 'Affiliation': 'Department of Gastroenterology, Hospital General de Tomelloso, Tomelloso, Spain; Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Madrid, Spain; Instituto de Investigación Sanitaria Princesa, Madrid, Spain.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Miehlke', 'Affiliation': 'Center for Digestive Diseases, Internal Medicine Center Eppendorf, Hamburg, Germany; Center for Esophageal Disorders, University Hospital Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vieth', 'Affiliation': 'Institute for Pathology, Klinikum Bayreuth, Bayreuth, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schlag', 'Affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Biedermann', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Cecilio Santander', 'Initials': 'CS', 'LastName': 'Vaquero', 'Affiliation': 'Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Madrid, Spain; Instituto de Investigación Sanitaria Princesa, Madrid, Spain; Servicio de Aparato Digestivo, Hospital Universitario de La Princesa, Madrid, Spain.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'Ciriza de Los Rios', 'Affiliation': 'Department of Gastroenterology, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schmoecker', 'Affiliation': 'Department of Gastroenterology, Sana Klinikum Lichtenberg, Berlin, Germany.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Madisch', 'Affiliation': 'Department of Gastroenterology, CRH Clinic Siloah, Hannover, Germany.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Hruz', 'Affiliation': 'Department of Gastroenterology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Hayat', 'Affiliation': ""Department of Gastroenterology, Saint George's University Hospitals National Health Service Trust, London, UK.""}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'von Arnim', 'Affiliation': 'Department of Gastroenterology, Hepatology and Infectious Diseases, University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Albert Jan', 'Initials': 'AJ', 'LastName': 'Bredenoord', 'Affiliation': 'Department of Gastroenterology and Hepatology, Academic Medical Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schubert', 'Affiliation': 'Private Practice, Berlin, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Mueller', 'Affiliation': 'Department of Clinical Research and Development, Dr Falk Pharma GmbH, Freiburg, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Greinwald', 'Affiliation': 'Department of Clinical Research and Development, Dr Falk Pharma GmbH, Freiburg, Germany.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Schoepfer', 'Affiliation': 'Department of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Attwood', 'Affiliation': 'Department of Health Services Research, Durham University, Durham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastroenterology,['10.1053/j.gastro.2020.07.039']
1241,32729820,"Pharmacokinetics, pharmacodynamics, and tolerability of JY09 in healthy Chinese subjects: A titrating, dose-escalating study.","OBJECTIVES


To evaluate the pharmacokinetics, pharmacodynamics, and tolerability of JY09, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist, in healthy subjects.
MATERIALS AND METHODS


Healthy subjects were enrolled into 5 cohorts (0.3, 0.7, 1.5, 3.0, and 6.0 mg JY09) and received subcutaneous JY09 or placebo according to a randomized, double-blind, placebo-controlled, single-center, dose-escalating phase I trial design. Blood samples were collected over a 42-day period, and JY09 in plasma was determined by an electrochemical luminescence method. For the pharmacodynamic evaluation, oral glucose tolerance tests (OGTTs) were conducted predose and on day 5 after the target dose, during which plasma glucose, insulin, C-peptide, and glucagon concentrations were analyzed. Tolerability was assessed using physical examination and queries, vital sign measurements, laboratory analysis, and detection of immunogenicity.
RESULTS


In healthy Chinese subjects, JY09 exhibited a dose-dependent increase in AUC 0-inf  and C max  from 0.7 to 6.0 mg JY09. The half-life of JY09 was ~ 9.3 days, and the peak concentration was reached at ~ 60 - 72 hours. Following the OGTT, an increase in C-peptide concentration was observed after exposure to JY09 at the dose of 6.0 mg compared to the placebo group. JY09 was well tolerated in healthy Chinese subjects following a single dose of up to 6.0 mg. No symptomatic hypoglycemia was reported, and the most commonly observed adverse event was suppressed appetite, and its incidence was dose-dependent. Four subjects (13%) developed anti-JY09 antibodies.
CONCLUSION


JY09 has a long half-life of ~ 9.3 days, with an acceptable safety profile.",2020,"In healthy Chinese subjects, JY09 exhibited a dose-dependent increase in AUC 0-inf  and C max  from 0.7 to 6.0 mg JY09.","['Healthy subjects were enrolled into 5 cohorts (0.3, 0.7, 1.5, 3.0, and 6.0 mg JY09) and received', 'healthy Chinese subjects', 'healthy subjects']","['subcutaneous JY09 or placebo', 'placebo']","['symptomatic hypoglycemia', 'tolerated', 'plasma glucose, insulin, C-peptide, and glucagon concentrations', 'Blood samples', 'AUC 0-inf  and C max', 'peak concentration', 'C-peptide concentration', 'pharmacokinetics, pharmacodynamics, and tolerability', 'physical examination and queries, vital sign measurements, laboratory analysis, and detection of immunogenicity', 'Tolerability', 'Pharmacokinetics, pharmacodynamics, and\xa0tolerability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",,0.236705,"In healthy Chinese subjects, JY09 exhibited a dose-dependent increase in AUC 0-inf  and C max  from 0.7 to 6.0 mg JY09.","[{'ForeName': 'Guangyu', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': ''}, {'ForeName': 'Yuanxun', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Geng', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Junyi', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Zuyi', 'Initials': 'Z', 'LastName': 'Weng', 'Affiliation': ''}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': ''}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203730']
1242,32729824,Multiple-dose pharmacokinetics and safety of amoxicillin/clavulanate in healthy elderly subjects.,"BACKGROUND


Amoxicillin/clavulanate is a widely used oral formulation of penicillin combined with a β-lactamase inhibitor. When using amoxicillin/clavulanate in the elderly, the risk of adverse drug reaction may be greater. This study aimed to evaluate the pharmacokinetics (PKs) and safety of multiple-dose amoxicillin/clavulanate administration in healthy elderly subjects and to compare the observed PK profiles with those in healthy younger adults. An open-label, one-sequence, multiple administration study was conducted in 16 healthy elderly subjects.
MATERIALS AND METHODS


Subjects orally received amoxicillin and clavulanate 750/187.5 twice daily for 9 days. For PK analysis, serial blood samples were collected up to 12 hours after the last administration of amoxicillin/clavulanate. The demographic and PK data of this study were compared to those of healthy young adults from a separate study with a similar design. Safety assessments including clinical laboratory tests, physical examination, vital signs, and adverse event (AE) monitoring were performed throughout the study.
RESULTS


All AEs were mild, and no serious AEs were reported in this study. The systemic exposure of amoxicillin and clavulanate was ~ 90% and 60% higher, respectively, in the elderly subjects than in the younger subjects. However, the time required to reach maximum concentration at steady state and the elimination half-life were similar in the two age groups.
CONCLUSION


Although multiple administration of amoxicillin/clavulanate 750/187.5 mg was safe and well-tolerated, the systemic exposure of amoxicillin and clavulanate was higher in elderly subjects than in younger subjects.",2020,"The systemic exposure of amoxicillin and clavulanate was ~ 90% and 60% higher, respectively, in the elderly subjects than in the younger subjects.","['healthy young adults', 'healthy younger adults', 'healthy elderly subjects', '16 healthy elderly subjects', 'healthy elderly subjects\u2029', 'elderly subjects than in younger subjects', 'Subjects orally received']","['Amoxicillin/clavulanate', 'amoxicillin/clavulanate', 'amoxicillin and clavulanate']","['systemic exposure of amoxicillin and clavulanate', 'clinical laboratory tests, physical examination, vital signs, and adverse event (AE) monitoring', 'safe and well-tolerated, the systemic exposure of amoxicillin and clavulanate']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",16.0,0.0121701,"The systemic exposure of amoxicillin and clavulanate was ~ 90% and 60% higher, respectively, in the elderly subjects than in the younger subjects.","[{'ForeName': 'Sang Won', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Yewon', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Kyungho', 'Initials': 'K', 'LastName': 'Jang', 'Affiliation': ''}, {'ForeName': 'Seo Hyun', 'Initials': 'SH', 'LastName': 'Yoon', 'Affiliation': ''}, {'ForeName': 'Jae-Yong', 'Initials': 'JY', 'LastName': 'Chung', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203773']
1243,32734691,"Genetic variation in lean body mass, changes of appetite and weight loss in response to diet interventions: The POUNDS Lost trial.","AIM


To investigate whether the genetic risk score (GRS) for lean body mass (LBM) modified the effects of weight-loss diets on changes in appetite and adiposity among overweight and obese individuals.
PARTICIPANTS AND METHODS


In the 2-year Preventing Overweight Using Novel Dietary Strategies (POUNDS Lost) trial, we included 692 adults who were randomly assigned to one of four diets varying in macronutrient intake. A GRS was calculated using five single nucleotide polymorphisms associated with LBM.
RESULTS


The LBM-GRS was not associated with the baseline LBM measured by dual-energy x-ray absorptiometry in a subgroup (50%) of the study population. We found that the LBM-GRS had significantly different associations with changes in appetite from baseline to 6 months according to low- or high-fat diet group (P-interaction < 0.001, 0.021, 0.005 and 0.024 for total appetite score, hunger, fullness and prospective consumption, respectively). Lower LBM-GRS (indicating a greater genetic predisposition to LBM) was associated with greater decreases in the total appetite score (P < 0.001), hunger (P = 0.01), fullness (P = 0.001) and prospective consumption (P = 0.019) in participants in the low-fat diet group, whereas no significant associations with these appetite measures were observed in the high-fat diet group. In addition, lower LBM-GRS was associated with greater reduction in body weight (P = 0.003) and waist circumference (P = 0.011) among participants in the low-fat diet group, while no associations were observed in the high-fat diet group. The interactions attenuated, along with weight regain, from 6 months to 2 years.
CONCLUSIONS


Our findings suggest that genetic variation in LBM may be differentially associated with appetite changes, and may subsequently be related to changes in body weight and waist circumference, according to dietary fat intake.",2020,The LBM-GRS was not associated with the baseline LBM measured by dual-energy x-ray absorptiometry in a subgroup (50%) of the study population.,"['overweight and obese individuals', '692 adults who were randomly assigned to 1 of 4']","['weight-loss diets', 'LBM-GRS', 'diets varying in macronutrient intake']","['appetite and adiposity', 'hunger', 'appetite measures', 'waist circumference', 'fullness', 'body weight', 'total appetite score', 'appetite', 'total appetite score, hunger, fullness, and prospective consumption, respectively', 'genetic risk score (GRS']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",692.0,0.0282244,The LBM-GRS was not associated with the baseline LBM measured by dual-energy x-ray absorptiometry in a subgroup (50%) of the study population.,"[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Yoriko', 'Initials': 'Y', 'LastName': 'Heianza', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Champagne', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Williamson', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14155']
1244,32738409,Acute effects of adaptive Deep Brain Stimulation in Parkinson's disease.,"BACKGROUND


Beta-based adaptive Deep Brain Stimulation (aDBS) is effective in Parkinson's disease (PD), when assessed in the immediate post-implantation phase. However, the potential benefits of aDBS in patients with electrodes chronically implanted, in whom changes due to the microlesion effect have disappeared, are yet to be assessed.
METHODS


To determine the acute effectiveness and side-effect profile of aDBS in PD compared to conventional continuous DBS (cDBS) and no stimulation (NoStim), years after DBS implantation, 13 PD patients undergoing battery replacement were pseudo-randomised in a crossover fashion, into three conditions (NoStim, aDBS or cDBS), with a 2-min interval between them. Patient videos were blindly evaluated using a short version of the Unified Parkinson's Disease Rating Scale (subUPDRS), and the Speech Intelligibility Test (SIT).
RESULTS


Mean disease duration was 16 years, and the mean time since DBS-implantation was 6.9 years. subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p = .001), when compared to NoStim. Bradykinesia subscores were significantly lower in aDBS (p = .002), and did not achieve significance during cDBS (p = .08), when compared to NoStim. Two patients demonstrated re-emerging tremor during aDBS. SIT scores of patients who presented stimulation-induced dysarthria significantly worsened in cDBS (p = .009), but not in aDBS (p = .407), when compared to NoStim. Overall, stimulation was applied 48.8% of the time during aDBS.
CONCLUSION


Beta-based aDBS is effective in PD patients with bradykinetic phenotypes, delivers less stimulation than cDBS, and potentially has a more favourable speech side-effect profile. Patients with prominent tremor may require a modified adaptive strategy.",2020,"subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p=.001), when compared to NoStim.","[""Parkinson's disease"", 'PD patients with bradykinetic phenotypes', '13 PD patients undergoing battery replacement', 'Patients with prominent tremor', ""Parkinson's disease (PD""]","['aDBS', 'Adaptive Deep Brain Stimulation', 'Beta-based aDBS', 'Beta-based adaptive Deep Brain Stimulation (aDBS', 'conventional continuous DBS (cDBS) and no stimulation (NoStim), years after DBS implantation']","['Mean disease duration', 'subUPDRS scores', 'SIT scores', ""Unified Parkinson's Disease Rating Scale (subUPDRS), and the Speech Intelligibility Test (SIT"", 'mean time since DBS-implantation', 'Bradykinesia subscores']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0445093', 'cui_str': 'No stimulation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}]",,0.0348207,"subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p=.001), when compared to NoStim.","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Piña-Fuentes', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands; Medical Research Council Brain Network Dynamics Unit at the University of Oxford, United Kingdom; Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom; Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'J Marc C', 'Initials': 'JMC', 'LastName': 'van Dijk', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'van Zijl', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'Harmen R', 'Initials': 'HR', 'LastName': 'Moes', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'Teus', 'Initials': 'T', 'LastName': 'van Laar', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'D L Marinus', 'Initials': 'DLM', 'LastName': 'Oterdoom', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Little', 'Affiliation': 'Department of Movement Disorders and Neuromodulation, University of California San Francisco, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'Medical Research Council Brain Network Dynamics Unit at the University of Oxford, United Kingdom; Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Beudel', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans. Electronic address: m.beudel@amsterdamumc.nl.'}]",Brain stimulation,['10.1016/j.brs.2020.07.016']
1245,32743789,"Evaluation of BepanGel Hydrogel Efficacy and Tolerability Using an Abrasive Wound Model in a Within-Person, Single-Center, Randomized, Investigator-Blind Clinical Investigation.","INTRODUCTION


Over the last few years, it has been demonstrated that a moist environment enhances the healing process and reduces scar formation of wounds. Such moist conditions can be created and maintained using hydrogels. The aim of this study was to evaluate wound healing, cooling efficacy, local tolerability, and cosmetic appearance of abrasive wounds treated with BepanGel wound care hydrogel.
METHODS


This study was designed as a within-person, single-center, randomized, investigator-blind clinical investigation comparing a hydrogel-treated test field with an untreated test field in an abrasive wound model. In 33 subjects, two small superficial wounds were induced on the non-dominant forearms. Wounds were treated with BepanGel and covered with a standard semi-occlusive wound plaster or covered with a plaster alone for 11 consecutive days. Wound healing efficacy, cooling effect, and tolerability of the treatment were assessed over 12 investigational days. During follow-up at day 31, the cosmetic appearance of the wounds was evaluated.
RESULTS


On day 12, the test field treated with BepanGel was completely healed in nearly all subjects (97.0%) in contrast with the test field treated with a plaster alone (18.2%, AUC days 2-12  p < 0.0001) as assessed by a blinded investigator. Two-thirds of the unblinded subjects indicated an immediate cooling effect of the hydrogel (p = 0.0555). At the end of the investigation, the cosmetic appearance of the BepanGel-treated test fields scored superior to the fields treated with a plaster alone as evaluated by a blinded investigator (p = 0.0005) and the unblinded subjects (p = 0.0078). The hydrogel was generally well tolerated and no signs of infection or adverse events (AEs) related to the treatment were observed.
CONCLUSION


This evaluation shows that treatment of superficial cutaneous wounds with BepanGel results in improved wound healing as demonstrated by faster wound closure and a considerably better cosmetic appearance, while providing immediate cooling.
TRIAL REGISTRATION NUMBER


EUDAMED-No.: CIV-19-09-029744.",2020,"The hydrogel was generally well tolerated and no signs of infection or adverse events (AEs) related to the treatment were observed.
","['33 subjects, two small superficial wounds were induced on the non-dominant forearms']","['BepanGel and covered with a standard semi-occlusive wound plaster or covered with a plaster alone', 'BepanGel wound care hydrogel']","['cosmetic appearance', 'Wound healing efficacy, cooling effect, and tolerability', 'wound healing, cooling efficacy, local tolerability, and cosmetic appearance', 'tolerated and no signs of infection or adverse events (AEs', 'wound healing', 'immediate cooling effect']","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0332804', 'cui_str': 'Superficial wound'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}]","[{'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0460977', 'cui_str': 'Plasters'}, {'cui': 'C0886052', 'cui_str': 'Wound care'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}]","[{'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]",,0.0224654,"The hydrogel was generally well tolerated and no signs of infection or adverse events (AEs) related to the treatment were observed.
","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Bayer Consumer Care AG, Peter Merian-Strasse 84, 4002, Basel, Switzerland.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'de Salvo', 'Affiliation': 'Bayer Consumer Care AG, Peter Merian-Strasse 84, 4002, Basel, Switzerland.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Trapp', 'Affiliation': 'Bayer Consumer Care AG, Peter Merian-Strasse 84, 4002, Basel, Switzerland.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Wigger-Alberti', 'Affiliation': 'Bioskin GmbH, Messberg 4, 20095, Hamburg, Germany.'}, {'ForeName': 'Ragna', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Bioskin GmbH, Messberg 4, 20095, Hamburg, Germany.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Delcour', 'Affiliation': 'Oystershell Laboratories, Nijverheidsweg 10, 9820, Merelbeke, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Rossel', 'Affiliation': 'Oystershell Laboratories, Nijverheidsweg 10, 9820, Merelbeke, Belgium.'}, {'ForeName': 'Maarten T', 'Initials': 'MT', 'LastName': 'Huisman', 'Affiliation': 'Oystershell Laboratories, Nijverheidsweg 10, 9820, Merelbeke, Belgium. mh@oystershell.be.'}]",Dermatology and therapy,['10.1007/s13555-020-00432-5']
1246,32743813,Local prolonged release of antibiotic for prevention of sternal wound infections postcardiac surgery-A novel technology.,"INTRODUCTION


Sternal wound infection (SWI) is a devastating postcardiac surgical complication. D-PLEX 100  (D-PLEX) is a localized prolonged release compound applied as a prophylactic at the completion of surgery to prevent SWI. The D-PLEX technology platform is built as a matrix of alternating layers of polymers and lipids, entrapping an antibiotic (doxycycline). The objective of this study was to assess the safety profile and pharmacokinetics of D-PLEX in reducing SWI rates postcardiac surgery.
METHOD


Eighty-one patients were enrolled in a prospective single-blind randomized controlled multicenter study. Sixty patients were treated with both D-PLEX and standard of care (SOC) and 21 with SOC alone. Both groups were followed 6 months for safety endpoints. SWI was assessed at 90 days.
RESULTS


No SWI-related serious adverse events (SAEs) occurred in either group. The mean plasma C max  in patients treated with D-PLEX was about 10 times lower than the value detected following the oral administration of doxycycline hyclate with an equivalent overall dose, and followed by a very low plasma concentration over the next 30 days. There were no sternal infections in the D-PLEX group (0/60) while there was one patient with a sternal infection in the control group (1/21, 4.8%).
CONCLUSION


D-PLEX was found to be safe for use in cardiac surgery patients. By providing localized prophylactic prolonged release of broad-spectrum antibiotics, D-PLEX has the potential to prevent SWI postcardiac surgery and long-term postoperative hospitalization, reducing high-treatment costs, morbidity, and mortality.",2020,"RESULTS


No SWI-related serious adverse events (SAEs) occurred in either group.","['cardiac surgery patients', 'Eighty-one patients', 'Sixty patients were treated with both D-PLEX and standard of care (SOC) and 21 with SOC alone']","['doxycycline', 'D-PLEX', 'antibiotic (doxycycline']","['sternal infection', 'sternal infections', 'mean plasma C max', 'SWI', 'serious adverse events (SAEs']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.0487843,"RESULTS


No SWI-related serious adverse events (SAEs) occurred in either group.","[{'ForeName': 'Erez', 'Initials': 'E', 'LastName': 'Kachel', 'Affiliation': 'Department of Cardiac Surgery, Poriya Medical Center, Tiberias, Israel.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Moshkovitz', 'Affiliation': 'Department of Cardiothoracic Surgery, Assuta Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Sternik', 'Affiliation': 'Department of Cardiac Surgery, Sheba Medical Centre, Tel Hashomer, Israel.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Sahar', 'Affiliation': 'Department of Cardiothoracic Surgery, Soroka Medical Center, Beer Sheva, Israel.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Grosman-Rimon', 'Affiliation': 'Department of Cardiac Surgery, Poriya Medical Center, Tiberias, Israel.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Belotserkovsky', 'Affiliation': 'PolyPid Ltd, Petach-Tikva, Israel.'}, {'ForeName': 'Malka', 'Initials': 'M', 'LastName': 'Reichart', 'Affiliation': 'PolyPid Ltd, Petach-Tikva, Israel.'}, {'ForeName': 'Yafit', 'Initials': 'Y', 'LastName': 'Stark', 'Affiliation': 'PolyPid Ltd, Petach-Tikva, Israel.'}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Emanuel', 'Affiliation': 'PolyPid Ltd, Petach-Tikva, Israel.'}]",Journal of cardiac surgery,['10.1111/jocs.14890']
1247,32739611,Changes in technology acceptance among older people with dementia: the role of social robot engagement.,"OBJECTIVE


Emerging technologies such as social robots have shown to be effective in reducing loneliness and agitation for older people with dementia. However, the acceptance of technology (specifically social robots) was found to be low for older people with dementia. The current understanding of changes in technology acceptance following direct exposure is limited and lacks rigorous study design. This study examined the change in technology acceptance after a direct interaction with a humanoid social robot (Kabochan) that was deployed for long-term care facilities' residents with dementia.
METHODS


The technology acceptance was assessed using randomised control trials for a time frame of 32 weeks. A total of 103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong and were randomly allocated to either Kabochan-engagement group or control group. Participants in the engagement group interacted with Kabochan in an individual, non-facilitated approach. The behavioural engagement with Kabochan was observed by care workers and recorded into constructive engagement and non-engagement. Questionnaire surveys were taken placed at pre- and post-exposure with Kabochan to measure attitudes and beliefs towards technology. The questionnaire was based on previous studies on technology acceptance and included attitudes towards technology, perceived usefulness, perceived ease of use, technology self-efficacy, technology anxiety, and facilitating conditions.
RESULTS


Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group. Results further demonstrated that the magnitude of belief changes was related to the intensity of constructive behavioural engagement. Specifically, resident-robot behavioural engagement moderately improved attitudes towards technology (F = 11.62, p < 0.001, η p 2  = 0.11) and perceived usefulness (F = 5.75, p = 0.02, η p 2  = 0.06).
CONCLUSIONS


The study tentatively supports that exposure to Kabochan has potential for changing perceived ease of use but not for other beliefs and attitudes towards technology among long-term care residents with dementia. Direct engagement with a humanoid social robot might be promising in improving the perceived ease of use towards technology.",2020,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group.","['103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong', ""long-term care facilities' residents with dementia"", 'older people with dementia']","['humanoid social robot (Kabochan', 'humanoid social robot', 'Kabochan-engagement group or control group', 'Kabochan']","['Perceived ease of use', 'attitudes towards technology']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]",103.0,0.0256322,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ke', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong. Electronic address: kechen@hku.hk.'}, {'ForeName': 'Vivian Wei-Qun', 'Initials': 'VW', 'LastName': 'Lou', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong; Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: wlou@hku.hk.'}, {'ForeName': 'Kelvin Cheng-Kian', 'Initials': 'KC', 'LastName': 'Tan', 'Affiliation': 'Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: u3004055@connect.hku.hk.'}, {'ForeName': 'Man Yi', 'Initials': 'MY', 'LastName': 'Wai', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: gwai@skhwc.org.hk.'}, {'ForeName': 'Lai Lok', 'Initials': 'LL', 'LastName': 'Chan', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: llchan@skhwc.org.hk.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104241']
1248,32739044,Fully automated postoperative ventilation in cardiac surgery patients: a randomised clinical trial.,"BACKGROUND


Ensuring that lung-protective ventilation is achieved at scale is challenging in perioperative practice. Fully automated ventilation may be more effective in delivering lung-protective ventilation. Here, we compared automated lung-protective ventilation with conventional ventilation after elective cardiac surgery in haemodynamically stable patients.
METHODS


In this single-centre investigator-led study, patients were randomly assigned at the end of cardiac surgery to receive either automated (adaptive support ventilation) or conventional ventilation. The primary endpoint was the proportion of postoperative ventilation time characterised by exposure to predefined optimal, acceptable, and critical (injurious) ventilatory parameters in the first three postoperative hours. Secondary outcomes included severe hypoxaemia (Spo 2  <85%) and resumption of spontaneous breathing. Data are presented as mean (95% confidence intervals [CIs]).
RESULTS


We randomised 220 patients (30.4% females; age: 62-76 yr). Subjects randomised to automated ventilation (n=109) spent a 29.7% (95% CI: 22.1-37.4) higher mean proportion of postoperative ventilation time receiving optimal postoperative ventilation after surgery (P<0.001) compared with subjects receiving conventional postoperative ventilation (n=111). Automated ventilation also reduced the proportion of postoperative ventilation time that subjects were exposed to injurious ventilatory settings by 2.5% (95% CI: 1-4; P=0.003). Severe hypoxaemia was less likely in subjects randomised to automated ventilation (risk ratio: 0.26 [0.22-0.31]; P<0.01). Subjects resumed spontaneous breathing more rapidly when randomised to automated ventilation (hazard ratio: 1.38 [1.05-1.83]; P=0.03).
CONCLUSIONS


Fully automated ventilation in haemodynamically stable patients after cardiac surgery optimised lung-protective ventilation during postoperative ventilation, with fewer episodes of severe hypoxaemia and an accelerated resumption of spontaneous breathing.
CLINICAL TRIAL REGISTRATION


NCT03180203.",2020,"Subjects resumed spontaneous breathing more rapidly when randomised to automated ventilation (hazard ratio: 1.38 [1.05-1.83]; P=0.03).
","['cardiac surgery patients', '220 patients (30.4% females; age: 62-76 yr', 'haemodynamically stable patients']","['automated lung-protective ventilation with conventional ventilation', 'cardiac surgery to receive either automated (adaptive support ventilation) or conventional ventilation', 'postoperative ventilation time receiving optimal postoperative ventilation', 'automated ventilation', 'conventional postoperative ventilation']","['severe hypoxaemia (Spo 2  <85%) and resumption of spontaneous breathing', 'proportion of postoperative ventilation time characterised by exposure to predefined optimal, acceptable, and critical (injurious) ventilatory parameters', 'proportion of postoperative ventilation time', 'spontaneous breathing', 'Severe hypoxaemia', 'severe hypoxaemia']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0578150', 'cui_str': 'Hemodynamically stable'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4285752', 'cui_str': 'Adaptive servo-ventilation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",220.0,0.205065,"Subjects resumed spontaneous breathing more rapidly when randomised to automated ventilation (hazard ratio: 1.38 [1.05-1.83]; P=0.03).
","[{'ForeName': 'Ashley J R', 'Initials': 'AJR', 'LastName': 'De Bie', 'Affiliation': 'Department of Intensive Care Unit, Catharina Hospital Eindhoven, Eindhoven, Netherlands; Department of Electrical Engineering, Eindhoven University of Technology, Eindhoven, Netherlands. Electronic address: ashleydebiedekker@gmail.com.'}, {'ForeName': 'Ary Serpa', 'Initials': 'AS', 'LastName': 'Neto', 'Affiliation': 'Department of Intensive Care and Laboratory of Experimental Intensive Care and Anesthesiology, Amsterdam University Medical Centers, Amsterdam, Netherlands; Department of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'van Meenen', 'Affiliation': 'Department of Intensive Care and Laboratory of Experimental Intensive Care and Anesthesiology, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'Arthur R', 'Initials': 'AR', 'LastName': 'Bouwman', 'Affiliation': 'Department of Intensive Care Unit, Catharina Hospital Eindhoven, Eindhoven, Netherlands.'}, {'ForeName': 'Arnout N', 'Initials': 'AN', 'LastName': 'Roos', 'Affiliation': 'Department of Intensive Care Unit, Catharina Hospital Eindhoven, Eindhoven, Netherlands.'}, {'ForeName': 'Joost R', 'Initials': 'JR', 'LastName': 'Lameijer', 'Affiliation': 'Department of Radiology, Catharina Hospital Eindhoven, Eindhoven, Netherlands.'}, {'ForeName': 'Erik H M', 'Initials': 'EHM', 'LastName': 'Korsten', 'Affiliation': 'Department of Intensive Care Unit, Catharina Hospital Eindhoven, Eindhoven, Netherlands; Department of Electrical Engineering, Eindhoven University of Technology, Eindhoven, Netherlands.'}, {'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Schultz', 'Affiliation': 'Department of Intensive Care and Laboratory of Experimental Intensive Care and Anesthesiology, Amsterdam University Medical Centers, Amsterdam, Netherlands; Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alexander J G H', 'Initials': 'AJGH', 'LastName': 'Bindels', 'Affiliation': 'Department of Intensive Care Unit, Catharina Hospital Eindhoven, Eindhoven, Netherlands.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.06.037']
1249,32748181,Comparable effects on tear film parameters after femtosecond laser-assisted and conventional cataract surgery.,"PURPOSE


Dry eye symptoms after conventional cataract surgery are a very common problem. Until now, only few data are available on objective tear film parameters in regard to femtosecond laser-assisted cataract surgery (LCS). Aim of this study was therefore to analyze and compare tear film parameter changes between LCS and conventional cataract surgery.
METHODS


A consecutive group of 34 patients, scheduled for cataract surgery, were randomly selected for either LCS or conventional cataract surgery (17 patients/group). Tear film assessments including tear film osmolarity, Schirmer test, MMP-9 analysis via quantitative ELISA, corneal sensitivity, corneal fluorescein staining, and conjunctival fluorescein staining were sequentially evaluated pre- as well as 1 and 3 months postoperatively.
RESULTS


Both groups showed no significant difference in baseline characteristics. All surgeries were performed without any complications. After 1 and 3 months, there was no statistically significant difference in regard to tear film osmolarity (1 month: p = 0.81, 3 months: p = 1.0), Schirmer test (1 month: p = 0.35, 3 month: p = 0.08), and MMP-9 concentration (1 month: p = 0.36, 3 month: p = 0.28) between the two groups.
CONCLUSIONS


Neither LCS nor conventional cataract surgery affected objective tear film parameters significantly during our 3-month postoperative observation period. Hence, both surgical techniques can be equally used to treat patients without prior dry eye symptoms.",2020,"After 1 and 3 months, there was no statistically significant difference in regard to tear film osmolarity (1 month:","['34 patients, scheduled for cataract surgery']","['conventional cataract surgery', 'LCS', 'femtosecond laser-assisted and conventional cataract surgery', 'femtosecond laser-assisted cataract surgery (LCS', 'LCS or conventional cataract surgery', 'LCS and conventional cataract surgery']","['Tear film assessments including tear film osmolarity, Schirmer test, MMP-9 analysis via quantitative ELISA, corneal sensitivity, corneal fluorescein staining, and conjunctival fluorescein staining', 'MMP-9 concentration', 'tear film osmolarity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",34.0,0.01766,"After 1 and 3 months, there was no statistically significant difference in regard to tear film osmolarity (1 month:","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Schargus', 'Affiliation': 'Department of Ophthalmology, Heinrich-Heine-University Düsseldorf, Moorenstraße 5, 40225, Düsseldorf, Germany. marc.schargus@gmx.de.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Ivanova', 'Affiliation': 'Institute for Vision Science, University Eye Clinic, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Gesa', 'Initials': 'G', 'LastName': 'Stute', 'Affiliation': 'Experimental Eye Research Institute, University Eye Clinic, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'H Burkhard', 'Initials': 'HB', 'LastName': 'Dick', 'Affiliation': 'Institute for Vision Science, University Eye Clinic, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Stephanie C', 'Initials': 'SC', 'LastName': 'Joachim', 'Affiliation': 'Experimental Eye Research Institute, University Eye Clinic, Ruhr-University Bochum, Bochum, Germany.'}]",International ophthalmology,['10.1007/s10792-020-01532-z']
1250,32749459,"Intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR): a randomized, placebo-controlled, double-blinded trial.","AIMS


Cardiosphere-derived cells (CDCs) are cardiac progenitor cells that exhibit disease-modifying bioactivity in various models of cardiomyopathy and in previous clinical studies of acute myocardial infarction (MI), dilated cardiomyopathy, and Duchenne muscular dystrophy. The aim of the study was to assess the safety and efficacy of intracoronary administration of allogeneic CDCs in the multicentre, randomized, double-blinded, placebo-controlled, intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR) trial.
METHODS AND RESULTS


We enrolled patients 4 weeks to 12 months after MI, with left ventricular ejection fraction (LVEF) ≤45% and LV scar size ≥15% of LV mass by magnetic resonance imaging (MRI). A pre-specified interim analysis was performed when 6-month MRI data were available. The trial was subsequently stopped due to the low probability of detecting a significant treatment effect of CDCs based on the primary endpoint. Patients were randomly allocated in a 2:1 ratio to receive CDCs or placebo in the infarct-related artery by stop-flow technique. The primary safety endpoint was the occurrence, during 1-month post-intracoronary infusion, of acute myocarditis attributable to allogeneic CDCs, ventricular tachycardia- or ventricular fibrillation-related death, sudden unexpected death, or a major adverse cardiac event (death or hospitalization for heart failure or non-fatal MI or need for left ventricular assist device or heart transplant). The primary efficacy endpoint was the relative percentage change in infarct size at 12 months post-infusion as assessed by contrast-enhanced cardiac MRI. We randomly allocated 142 eligible patients of whom 134 were treated (90 to the CDC group and 44 to the placebo group). The mean baseline LVEF was 40% and the mean scar size was 22% of LV mass. No primary safety endpoint events occurred. There was no difference in the percentage change from baseline in scar size (P = 0.51) between CDCs and placebo groups at 6 months. Compared with placebo, there were significant reductions in LV end-diastolic volume (P = 0.02), LV end-systolic volume (P = 0.02), and N-terminal pro b-type natriuretic peptide (NT-proBNP) (P = 0.02) at 6 months in CDC-treated patients.
CONCLUSION


Intracoronary infusion of allogeneic CDCs in patients with post-MI LV dysfunction was safe but did not reduce scar size relative to placebo at 6 months. Nevertheless, the reductions in LV volumes and NT-proBNP reveal disease-modifying bioactivity of CDCs.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT01458405.",2020,There was no difference in the percentage change from baseline in scar size (P = 0.51) between CDCs and placebo groups at 6 months.,"['142 eligible patients of whom 134 were treated (90 to the CDC group and 44 to the placebo group', 'enrolled patients 4\u2009weeks to 12\u2009months after MI, with left ventricular ejection fraction (LVEF) ≤45% and LV scar size ≥15% of LV mass by magnetic resonance imaging (MRI', 'patients with post-MI LV dysfunction']","['Cardiosphere-derived cells (CDCs', 'placebo', 'CDCs or placebo', 'placebo-controlled, intracoronary ALLogeneic heart STem cells', 'Intracoronary ALLogeneic heart STem cells', 'allogeneic CDCs']","['relative percentage change in infarct size', 'mean baseline LVEF', 'scar size', 'LV volumes and NT-proBNP reveal disease-modifying bioactivity of CDCs', 'scar size relative', 'safety and efficacy', 'mean scar size', 'LV end-systolic volume', 'LV end-diastolic volume', 'occurrence, during 1-month post-intracoronary infusion, of acute myocarditis attributable to allogeneic CDCs, ventricular tachycardia- or ventricular fibrillation-related death, sudden unexpected death, or a major adverse cardiac event (death or hospitalization for heart failure or non-fatal MI or need for left ventricular assist device or heart transplant']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]","[{'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0155686', 'cui_str': 'Acute myocarditis'}, {'cui': 'C0042514', 'cui_str': 'Ventricular tachycardia'}, {'cui': 'C0042510', 'cui_str': 'Ventricular fibrillation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1276802', 'cui_str': 'Sudden'}, {'cui': 'C0277591', 'cui_str': 'Unexpected death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}]",142.0,0.688567,There was no difference in the percentage change from baseline in scar size (P = 0.51) between CDCs and placebo groups at 6 months.,"[{'ForeName': 'Raj R', 'Initials': 'RR', 'LastName': 'Makkar', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, CA 90048, USA.'}, {'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Kereiakes', 'Affiliation': 'The Christ Hospital, Cincinnati, 2139 Auburn Ave, Cincinnati, OH 45219, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Aguirre', 'Affiliation': 'Prairie/St. Johns Hospital, Springfield, 800 E Carpenter St, Springfield, IL 62769, USA.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Kowalchuk', 'Affiliation': 'Sanger Heart & Vascular, Charlotte, 1001 Blythe Blvd Ste 300, Charlotte, NC 28203, USA.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Chakravarty', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, CA 90048, USA.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Malliaras', 'Affiliation': 'University of Athens, 17 Agiou Thoma street, 11527, Athens, Greece.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Francis', 'Affiliation': 'University of Minnesota Heart Care, Minneapolis, 6405 France Ave S, Edina, MN 55435, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Povsic', 'Affiliation': 'Duke University Hospital, Durham, 2301 Erwin Rd, Durham, NC 27710, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schatz', 'Affiliation': 'Scripps Green Hospital, 10666 N Torrey Pines Rd, La Jolla, CA 92037, USA.'}, {'ForeName': 'Jay H', 'Initials': 'JH', 'LastName': 'Traverse', 'Affiliation': 'Minneapolis Heart Institute Foundation, 920 E 28th St Ste 100, Minneapolis, MN 55407, USA.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Pogoda', 'Affiliation': '10Capricor Therapeutics, Los Angeles, 8840 Wilshire Blvd Ste 2, Beverly Hills, CA 90211, USA.'}, {'ForeName': 'Rachel R', 'Initials': 'RR', 'LastName': 'Smith', 'Affiliation': '10Capricor Therapeutics, Los Angeles, 8840 Wilshire Blvd Ste 2, Beverly Hills, CA 90211, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Marbán', 'Affiliation': '10Capricor Therapeutics, Los Angeles, 8840 Wilshire Blvd Ste 2, Beverly Hills, CA 90211, USA.'}, {'ForeName': 'Deborah D', 'Initials': 'DD', 'LastName': 'Ascheim', 'Affiliation': '10Capricor Therapeutics, Los Angeles, 8840 Wilshire Blvd Ste 2, Beverly Hills, CA 90211, USA.'}, {'ForeName': 'Mohammad R', 'Initials': 'MR', 'LastName': 'Ostovaneh', 'Affiliation': 'J ohns Hopkins University, 3400 N Charles St, Baltimore, MD 21218, USA.'}, {'ForeName': 'João A C', 'Initials': 'JAC', 'LastName': 'Lima', 'Affiliation': 'J ohns Hopkins University, 3400 N Charles St, Baltimore, MD 21218, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'DeMaria', 'Affiliation': 'University of California San Diego Medical Center, 200 W. Arbor Drive, San Diego, CA 92103, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Marbán', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, CA 90048, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, CA 90048, USA.'}]",European heart journal,['10.1093/eurheartj/ehaa541']
1251,32745703,"Randomized controlled trial of the COPE-P intervention to improve mental health, healthy lifestyle behaviors, birth and post-natal outcomes of minority pregnant women: Study protocol with implications.","BACKGROUND


Emotionally distressed pregnant minority women experience multiple adverse outcomes, including pre-eclampsia, preterm birth, operative deliveries and low birth weight. Although the United States Preventive Services Task Force recommends screening in pregnant women, many practices do not screen because efficacious interventions and systems are not in place to treat them.
AIM


Purpose of this randomized controlled trial (RCT) is to test a group delivered manualized cognitive-behavioral skills building intervention entitled COPE-P versus an attention control program on the mental health, birth and postpartum outcomes of minority pregnant women experiencing depressive, anxiety and stress symptoms.
METHODS


Design is a longitudinal randomized block RCT with repeated measures (beginning with screening prior to 18 weeks, group prenatal care in both groups from 16 + 1 to 31 + 1 weeks and ending at 6 months postpartum) at two study sites (New York city and Columbus, Ohio). Race/ethnicity is being blocked to ensure equal numbers of Hispanic and Black women. 384 women are being recruited from antenatal clinics if they are: between 18 and 40 years; in an uncomplicated singleton pregnancy <18 weeks; and self-identify as Black or Hispanic. Valid and reliable measures are being used to assess healthy lifestyle behaviors and mental health outcomes immediately following the interventions, six - eight weeks postpartum and at the children's six-month well baby visit. Birth and delivery outcomes also are being assessed.
CONCLUSION


If found to be efficacious, the COPE-P intervention could be a key solution to managing those with emotional distress and improving their outcomes.",2020,"If found to be efficacious, the COPE-P intervention could be a key solution to managing those with emotional distress and improving their outcomes.","['minority pregnant women experiencing depressive, anxiety and stress symptoms', 'minority pregnant women', '384 women are being recruited from antenatal clinics if they are: between 18 and 40\u202fyears; in an uncomplicated singleton pregnancy <18\u202fweeks; and self-identify as Black or Hispanic', 'pregnant women']","['COPE-P intervention', 'COPE-P versus an attention control program']","['healthy lifestyle behaviors and mental health outcomes', 'mental health, healthy lifestyle behaviors, birth and post-natal outcomes']","[{'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0454729', 'cui_str': 'Natal'}]",384.0,0.137281,"If found to be efficacious, the COPE-P intervention could be a key solution to managing those with emotional distress and improving their outcomes.","[{'ForeName': 'Bernadette Mazurek', 'Initials': 'BM', 'LastName': 'Melnyk', 'Affiliation': 'Health Promotion and Wellness, The Ohio State University, the Helene Fuld Health Trust National Institute for Evidence-based Practice in Nursing and Healthcare, College of Nursing, Pediatrics & Psychiatry, College of Medicine, The Ohio State University, 1585 Neil Ave, Columbus, OH 43210, United States of America. Electronic address: melnyk.15@osu.edu.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gennaro', 'Affiliation': 'William F. Connell School of Nursing, Boston College, Chestnut Hill, MA, United States of America.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Szalacha', 'Affiliation': 'Research Methodology and Biostatistics Core, USF Health Morsani College of Medicine, College of Nursing, University of South Florida, United States of America.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Hoying', 'Affiliation': 'Consumer Core, the Helene Fuld Health Trust National Institute for Evidence-based Practice in Nursing and Healthcare, The Ohio State University College of Nursing, Columbus, OH, United States of America.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'William F. Connell School of Nursing, Boston College, Chestnut Hill, MA, United States of America.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cooper', 'Affiliation': 'The Ohio State University College of Nursing, Columbus, OH, United States of America.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gibeau', 'Affiliation': 'Midwifery, Jacobi Medical Center, Bronx, NY, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106090']
1252,32749942,Efficacy of Maintenance Olaparib for Patients With Newly Diagnosed Advanced Ovarian Cancer With a BRCA Mutation: Subgroup Analysis Findings From the SOLO1 Trial.,"PURPOSE


In SOLO1, maintenance olaparib (300 mg twice daily) significantly improved progression-free survival (PFS) for patients with newly diagnosed  BRCA1 - and/or  BRCA2 -mutated advanced ovarian cancer compared with placebo (hazard ratio [HR], 0.30; 95% CI, 0.23 to 0.41; median not reached  v  13.8 months). We investigated PFS in SOLO1 for subgroups of patients based on preselected baseline factors.
PATIENTS AND METHODS


Investigator-assessed PFS subgroup analyses of SOLO1 included clinical response after platinum-based chemotherapy (complete [CR] or partial response [PR]), surgery type (upfront or interval surgery), disease status after surgery (residual or no gross residual disease), and BRCA mutation status ( BRCA1  or  BRCA2 ). Additionally, we evaluated PFS in patients with stage III disease who underwent upfront surgery and had no gross residual disease. We also report objective response rate.
RESULTS


The risk of disease progression or death was reduced with olaparib compared with placebo by 69% (HR, 0.31; 95% CI, 0.21 to 0.46) and 63% (HR, 0.37; 95% CI, 0.24 to 0.58) in patients undergoing upfront or interval surgery; 56% (HR, 0.44; 95% CI, 0.25 to 0.77) and 67% (HR, 0.33; 95% CI, 0.23 to 0.46) in patients with residual or no residual disease after surgery; 66% (HR, 0.34; 95% CI, 0.24 to 0.47) and 69% in women with clinical CR or PR at baseline (HR, 0.31; 95% CI, 0.18 to 0.52); and 59% (HR, 0.41; 95% CI, 0.30 to 0.56) and 80% (HR 0.20; 95% CI, 0.10 to 0.37) in patients with a  BRCA1  or  BRCA2  mutation, respectively.
CONCLUSION


Patients with newly diagnosed advanced ovarian cancer achieve substantial benefit from maintenance olaparib treatment regardless of baseline surgery outcome, response to chemotherapy, or BRCA mutation type.",2020,"The risk of disease progression or death was reduced with olaparib compared with placebo by 69% (HR, 0.31; 95% CI, 0.21 to 0.46) and 63% (HR, 0.37; 95% CI, 0.24 to 0.58) in patients undergoing upfront or interval surgery; 56% (HR, 0.44; 95% CI, 0.25 to 0.77) and 67% (HR, 0.33; 95% CI, 0.23 to 0.46) in patients with residual or no residual disease after surgery; 66% (HR, 0.34; 95% CI, 0.24 to 0.47) and 69% in women with clinical CR or PR at baseline (HR, 0.31; 95% CI, 0.18 to 0.52); and 59% (HR, 0.41; 95% CI, 0.30 to 0.56) and 80% (HR 0.20; 95% CI, 0.10 to 0.37) in patients with a  BRCA1  or  BRCA2  mutation, respectively.
","['Patients With Newly Diagnosed Advanced Ovarian Cancer', 'Patients with newly diagnosed advanced ovarian cancer', 'patients with stage III disease who underwent upfront surgery and had no gross residual disease']","['Maintenance Olaparib', 'platinum-based chemotherapy (complete [CR] or partial response [PR]), surgery type (upfront or interval surgery', 'placebo']","['progression-free survival (PFS', 'risk of disease progression or death', 'disease status after surgery (residual or no gross residual disease), and BRCA mutation status ( BRCA1  or  BRCA2 ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C2973986', 'cui_str': 'BRCA2 protein, human'}]",,0.426993,"The risk of disease progression or death was reduced with olaparib compared with placebo by 69% (HR, 0.31; 95% CI, 0.21 to 0.46) and 63% (HR, 0.37; 95% CI, 0.24 to 0.58) in patients undergoing upfront or interval surgery; 56% (HR, 0.44; 95% CI, 0.25 to 0.77) and 67% (HR, 0.33; 95% CI, 0.23 to 0.46) in patients with residual or no residual disease after surgery; 66% (HR, 0.34; 95% CI, 0.24 to 0.47) and 69% in women with clinical CR or PR at baseline (HR, 0.31; 95% CI, 0.18 to 0.52); and 59% (HR, 0.41; 95% CI, 0.30 to 0.56) and 80% (HR 0.20; 95% CI, 0.10 to 0.37) in patients with a  BRCA1  or  BRCA2  mutation, respectively.
","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'DiSilvestro', 'Affiliation': 'Women & Infants Hospital, Providence, RI.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), University of Milan-Bicocca, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Fondazione Policlinico Universitario A Gemelli, IRCCS, Università Cattolica, Rome, Italy.'}, {'ForeName': 'Byoung-Gie', 'Initials': 'BG', 'LastName': 'Kim', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oaknin', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'University of New South Wales Clinical School, Prince of Wales Hospital, Randwick, New South Wales, Australia.'}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Lisyanskaya', 'Affiliation': 'St Petersburg City Oncology Dispensary, St Petersburg, Russia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Floquet', 'Affiliation': 'Institut Bergonié, Comprehensive Cancer Centre, Bordeaux, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Leary', 'Affiliation': 'Gustave-Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Gabe S', 'Initials': 'GS', 'LastName': 'Sonke', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Gourley', 'Affiliation': 'Cancer Research UK Edinburgh Centre, Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'The Royal Marsden National Health Service Foundation Trust and Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Oza', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'González-Martín', 'Affiliation': 'Clínica Universidad de Navarra, Madrid, Spain.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, NY.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Bradley', 'Affiliation': 'Froedtert and the Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Cara A', 'Initials': 'CA', 'LastName': 'Mathews', 'Affiliation': 'Women & Infants Hospital, Providence, RI.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Lowe', 'Affiliation': 'AstraZeneca, Gaithersburg, MD.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Bloomfield', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Kathleen N', 'Initials': 'KN', 'LastName': 'Moore', 'Affiliation': 'Stephenson Cancer Center, University of Oklahoma, Oklahoma City, OK.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00799']
1253,32756067,Feasibility of a Cognitive Training Game in Parkinson's Disease: The Randomized Parkin'Play Study.,"Cognitive training (CT) shows modest positive effects on cognitive function in patients with Parkinson's disease (PD). Gamification may enhance adherence to traditional CT, but this has not been studied yet. Here, we investigated the feasibility of a gamified CT. We performed a randomized controlled trial including PD patients with mild cognitive impairment. Participants were randomly allocated to a 12-week home-based gamified CT intervention or waiting-list control group. Assessments were performed at baseline and at weeks 12 and 24. Forty-one patients were included (21 intervention and 20 waiting-list controls). Sixty-three percent of the intervention group trained >50% of the recommended sessions, while 81% voluntarily continued training after 12 weeks. After 24 weeks, 87.5% graded the game to be satisfactory. Global cognition scores improved after 24 weeks. Home-based gamified CT shows acceptable feasibility in patients with PD, and we observed preliminary indications for efficacy. Larger trials are needed to establish this efficacy.",2020,Global cognition scores improved after 24 weeks.,"[""patients with Parkinson's disease (PD"", ""Parkinson's Disease"", 'PD patients with mild cognitive impairment', 'patients with PD', 'Forty-one patients were included (21 intervention and 20 waiting-list controls']","['gamified CT', 'Cognitive Training Game', '12-week home-based gamified CT intervention or waiting-list control group', 'Cognitive training (CT']","['cognitive function', 'Global cognition scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",41.0,0.0472378,Global cognition scores improved after 24 weeks.,"[{'ForeName': 'Sjors C F', 'Initials': 'SCF', 'LastName': 'van de Weijer', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands, sjors.vande.weijer@mumc.nl.'}, {'ForeName': 'Annelien A', 'Initials': 'AA', 'LastName': 'Duits', 'Affiliation': 'Department of Psychiatry and Psychology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Department of Neurology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'de Vries', 'Affiliation': 'Department of Neurology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Roy P C', 'Initials': 'RPC', 'LastName': 'Kessels', 'Affiliation': 'Department of Medical Psychology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Köhler', 'Affiliation': 'School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Tissingh', 'Affiliation': 'Department of Neurology, Zuyderland Medical Center, Heerlen, The Netherlands.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Kuijf', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.'}]",European neurology,['10.1159/000509685']
1254,32716280,Cardiac rehabilitation in the paediatric Fontan population: development of a home-based high-intensity interval training programme.,"INTRODUCTION


We evaluated the safety and feasibility of high-intensity interval training via a novel telemedicine ergometer (MedBIKE™) in children with Fontan physiology.
METHODS


The MedBIKE™ is a custom telemedicine ergometer, incorporating a video game platform and live feed of patient video/audio, electrocardiography, pulse oximetry, and power output, for remote medical supervision and modulation of work. There were three study phases: (I) exercise workload comparison between the MedBIKE™ and a standard cardiopulmonary exercise ergometer in 10 healthy adults. (II) In-hospital safety, feasibility, and user experience (via questionnaire) assessment of a MedBIKE™ high-intensity interval training protocol in children with Fontan physiology. (III) Eight-week home-based high-intensity interval trial programme in two participants with Fontan physiology.
RESULTS


There was good agreement in oxygen consumption during graded exercise at matched work rates between the cardiopulmonary exercise ergometer and MedBIKE™ (1.1 ± 0.5 L/minute versus 1.1 ± 0.5 L/minute, p = 0.44). Ten youth with Fontan physiology (11.5 ± 1.8 years old) completed a MedBIKE™ high-intensity interval training session with no adverse events. The participants found the MedBIKE™ to be enjoyable and easy to navigate. In two participants, the 8-week home-based protocol was tolerated well with completion of 23/24 (96%) and 24/24 (100%) of sessions, respectively, and no adverse events across the 47 sessions in total.
CONCLUSION


The MedBIKE™ resulted in similar physiological responses as compared to a cardiopulmonary exercise test ergometer and the high-intensity interval training protocol was safe, feasible, and enjoyable in youth with Fontan physiology. A randomised-controlled trial of a home-based high-intensity interval training exercise intervention using the MedBIKE™ will next be undertaken.",2020,"The MedBIKE™ resulted in similar physiological responses as compared to a cardiopulmonary exercise test ergometer and the high-intensity interval training protocol was safe, feasible, and enjoyable in youth with Fontan physiology.","['two participants with Fontan physiology', '10 healthy adults', 'Ten youth with Fontan physiology (11.5 ± 1.8 years old) completed a MedBIKE™ high-intensity interval training session with no adverse events', 'children with Fontan physiology', 'paediatric Fontan population']","['high-intensity interval training via a novel telemedicine ergometer (MedBIKE™', 'exercise workload comparison between the MedBIKE™ and a standard cardiopulmonary exercise ergometer', 'home-based high-intensity interval training exercise intervention', 'Cardiac rehabilitation', 'MedBIKE™ high-intensity interval training protocol']",['oxygen consumption'],"[{'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C1963761', 'cui_str': 'No adverse event'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",2.0,0.0310135,"The MedBIKE™ resulted in similar physiological responses as compared to a cardiopulmonary exercise test ergometer and the high-intensity interval training protocol was safe, feasible, and enjoyable in youth with Fontan physiology.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Khoury', 'Affiliation': ""Division of Pediatric Cardiology, Department of Pediatrics, Stollery Children's Hospital, University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Devin B', 'Initials': 'DB', 'LastName': 'Phillips', 'Affiliation': 'Division of Pulmonary Medicine, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Wood', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Mott', 'Affiliation': 'Department of Computing Science, Faculty of Science, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Stickland', 'Affiliation': 'Division of Pulmonary Medicine, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boulanger', 'Affiliation': 'Department of Computing Science, Faculty of Science, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Gwen R', 'Initials': 'GR', 'LastName': 'Rempel', 'Affiliation': 'Faculty of Health Disciplines, Athabasca University, Alberta, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Conway', 'Affiliation': ""Division of Pediatric Cardiology, Department of Pediatrics, Stollery Children's Hospital, University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Mackie', 'Affiliation': ""Division of Pediatric Cardiology, Department of Pediatrics, Stollery Children's Hospital, University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Nee S', 'Initials': 'NS', 'LastName': 'Khoo', 'Affiliation': ""Division of Pediatric Cardiology, Department of Pediatrics, Stollery Children's Hospital, University of Alberta, Edmonton, Alberta, Canada.""}]",Cardiology in the young,['10.1017/S1047951120002097']
1255,32729141,Comparison of surgical outcomes using Gyrus PKS™ vs LigaSure™ in total laparoscopic hysterectomy: A randomised controlled trial.,"BACKGROUND


Advanced vessel sealing devices are widely used in laparoscopic surgery. However, there remains a lack of adequately powered trials comparing laparoscopic advanced vessel sealing devices in the clinical setting, especially in gynaecology.
AIMS


This single-blinded randomised controlled trial aims to compare the surgical outcomes of total laparoscopic hysterectomy (TLH) using either the Gyrus PKS™ LYONS dissecting forceps or the LigaSure™ Maryland jaw vessel sealer/divider.
MATERIALS AND METHODS


Women who required TLHs for benign indications were randomised to having their surgeries performed using either Gyrus PKS™ or LigaSure™. Time to haemostasis (from initial skin incision to detachment of the uterus with secured haemostasis) was the primary outcome; a 20% difference in time was considered clinically significant. Secondary outcomes measured were intra-operative blood loss, complications, conversions, post-operative analgesia use, and length of stay. This study was registered with the Australia New Zealand Clinical Trials Registry ACTRN12615000639516.
RESULTS


Sixty-four women were included in the study - 33 and 31 in the Gyrus PKS™ and LigaSure™ arms, respectively. TLHs performed by LigaSure™ had statistically significantly shorter time to haemostasis compared to Gyrus PKS™ by 10.6 min (95% CI 1.3-2.0, P = 0.03). There were no differences in any of the other secondary outcomes measured.
CONCLUSIONS


This trial suggests there is no difference between using either device. TLHs performed using LigaSure™ have statistically significantly shorter time to haemostasis than those using Gyrus PKS™; however, the difference is not considered clinically significant as it was only 14.2%. No other differences in surgical outcomes were detected.",2020,"TLHs performed by LigaSure™ had statistically significantly shorter time to haemostasis compared to Gyrus PKS™ by 10.6 min (95% CI 1.3-2.0, P = 0.03).","['total laparoscopic hysterectomy', 'Women who required TLHs for benign indications', 'Sixty-four women were included in the study - 33 and 31 in the Gyrus PKS™ and LigaSure™ arms, respectively']","['Gyrus PKS™ vs LigaSure', 'Gyrus PKS™ or LigaSure™', 'total laparoscopic hysterectomy (TLH']","['Time to haemostasis', 'intra-operative blood loss, complications, conversions, post-operative analgesia use, and length of stay', 'shorter time to haemostasis', 'surgical outcomes']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0265449', 'cui_str': 'Tetrasomy 12p'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0265449', 'cui_str': 'Tetrasomy 12p'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",64.0,0.336996,"TLHs performed by LigaSure™ had statistically significantly shorter time to haemostasis compared to Gyrus PKS™ by 10.6 min (95% CI 1.3-2.0, P = 0.03).","[{'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Sydney West Advanced Pelvic Surgery Unit, Sydney, New South Wales, Australia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Goh', 'Affiliation': 'Sydney West Advanced Pelvic Surgery Unit, Sydney, New South Wales, Australia.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Merkur', 'Affiliation': 'Sydney West Advanced Pelvic Surgery Unit, Sydney, New South Wales, Australia.'}]",The Australian & New Zealand journal of obstetrics & gynaecology,['10.1111/ajo.13217']
1256,32732105,Effect of self-administered vaginal dinoprostone on pain perception during copper intrauterine device insertion in parous women: a randomized controlled trial.,"OBJECTIVE(S)


To assess efficacy and safety of self-administered 3 mg dinoprostone vaginally in reducing pain during copper intrauterine device (IUD) insertion in parous women.
DESIGN


Randomized, double-blinded, placebo-controlled trial.
SETTING


Family planning clinic in a tertiary referral hospital.
PATIENT(S)


Multiparous women who were attending a family planning clinic and requesting copper IUD insertion.
INTERVENTIONS(S)


We randomly assigned 160 participants into two groups: The dinoprostone group (n = 80) received 3 mg dinoprostone vaginally, and the placebo group (n = 80) received placebo vaginally.
MAIN OUTCOME MEASURE(S)


Our primary outcome was mean pain scores during IUD insertion. Our secondary outcomes were mean pain scores during tenaculum application, during uterine sounding, and 15 minutes after insertion, ease of insertion, satisfaction score, need for additional analgesics, and side-effects.
RESULT(S)


Both groups showed no significant difference in anticipated pain score (P=.41), pain during tenaculum placement (P=.22), and pain during sound insertion (P=.07). The dinoprostone group had significantly lower pain scores during IUD insertion (34.8 ± 10.1 vs. 57.8 ± 11.8) and 15 minutes after insertion (20.6 ± 6.4 vs. 29.6 ± 6.2), easier IUD insertion (43.6 ± 21.9 vs. 64.7 ± 18.1), and higher satisfaction (83.9 ± 11.6 vs. 63.0 ± 9.1) compared with the placebo group. Fewer patients required additional analgesics in the dinoprostone group compared with the placebo group (P=.01). Side-effects were similar between the groups.
CONCLUSION(S)


Self-administered 3 mg dinoprostone vaginally before copper IUD insertion in parous women reduces pain scores during IUD insertion, making insertion easier and increasing women's satisfaction, with tolerable side-effects.
CLINICAL TRIAL REGISTRATION NUMBER


NCT04046302.",2020,"Both groups showed no significant difference in anticipated pain score (P=.41), pain during tenaculum placement (P=.22), and pain during sound insertion (P=.07).","['parous women', 'Multiparous women who were attending a family planning clinic and requesting copper IUD insertion', 'Family planning clinic in a tertiary referral hospital']","['dinoprostone', 'self-administered vaginal dinoprostone', 'placebo vaginally', 'placebo']","['pain during tenaculum placement (P=.22), and pain', 'pain scores', 'Side-effects', 'additional analgesics', 'pain during copper intrauterine device (IUD) insertion', 'easier IUD insertion', 'mean pain scores', 'anticipated pain score', 'mean pain scores during tenaculum application, during uterine sounding, and 15 minutes after insertion, ease of insertion, satisfaction score, need for additional analgesics, and side-effects', 'pain perception']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026751', 'cui_str': 'Multiparous'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C3840184', 'cui_str': 'Family planning clinic'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0180964', 'cui_str': 'Tenaculum'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",160.0,0.854206,"Both groups showed no significant difference in anticipated pain score (P=.41), pain during tenaculum placement (P=.22), and pain during sound insertion (P=.07).","[{'ForeName': 'Ahmed Sa', 'Initials': 'AS', 'LastName': 'Ashour', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Nabil', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed F', 'Initials': 'MF', 'LastName': 'Yosif', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hussein', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Mageed A Allah', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hossam', 'Initials': 'H', 'LastName': 'Abdou', 'Affiliation': 'Obstetrics and Gynecology, Helwan University, Cairo, Egypt.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Kholaif', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed Mahmoud', 'Initials': 'MM', 'LastName': 'Mohamed Kotb', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Sharkawy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Mohamed', 'Initials': 'AM', 'LastName': 'Abdelhakim', 'Affiliation': 'Kasr Al-Ainy Faculty of Medicine, Cairo University, Cairo, Egypt. Electronic address: ahmed.m.rohei@students.kasralainy.edu.eg.'}, {'ForeName': 'Ahmed Said', 'Initials': 'AS', 'LastName': 'Ali', 'Affiliation': 'Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Salma Ashraf', 'Initials': 'SA', 'LastName': 'Nassar', 'Affiliation': 'Obstetrics and Gynecology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Amr Hazim', 'Initials': 'AH', 'LastName': 'Abbassy', 'Affiliation': 'Obstetrics and Gynecology, National Research Center, Cairo, Egypt.'}, {'ForeName': 'Nevein Kamal', 'Initials': 'NK', 'LastName': 'Ghamry', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ali Abdelhafeez', 'Initials': 'AA', 'LastName': 'Abdel-Latif', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Taher', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Mahy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.05.004']
1257,32737482,Switching from boosted PIs to dolutegravir in HIV-infected patients with high cardiovascular risk: 48 week effects on subclinical cardiovascular disease.,"BACKGROUND


Switching from boosted PIs to dolutegravir in virologically suppressed HIV-infected patients with high cardiovascular risk significantly decreased total cholesterol and other proatherogenic lipid fractions at 48 weeks. The impact of this strategy on subclinical cardiovascular disease is unknown.
METHODS


NEAT022 is a European, multicentre, open-label, randomized, non-inferiority trial. HIV-infected adults aged >50 years or with a Framingham score >10% were eligible if plasma HIV RNA was <50 copies/mL for >24 weeks on a boosted PI-based regimen. Patients were randomized 1:1 to switch from boosted PIs to dolutegravir or to continue on boosted PIs. Common carotid arteries intima-media thickness (CIMT) and pulse wave velocity (PWV) were measured following a standardized protocol in a subgroup of NEAT022 study participants at baseline and at Week 48.
RESULTS


One hundred and fifty-six patients participated in the ultrasonography and arterial stiffness substudies, respectively. In each substudy, population characteristics did not differ between arms and matched those of the main study. At 48 weeks, patients who switched to dolutegravir had lower mean progression of both right (+4 versus +14.6 μm) and left (-6.1 versus +1.6 μm) CIMT and also a smaller increase in mean PWV (+0.18 versus +0.39 m/s) than patients continuing on boosted PIs, although differences were not statistically significant. CIMT trends were consistent across Framingham score, age and country. Inconsistent effects were seen in arterial stiffness.
CONCLUSIONS


Relative to continuing on boosted PIs, switching to dolutegravir in virologically suppressed patients with high cardiovascular risk showed consistent favourable although non-significant trends on CIMT progression at 48 weeks.",2020,"Common carotid arteries intima-media thickness (CIMT) and pulse wave velocity (PWV) were measured following a standardized protocol in a subgroup of NEAT022 study participants at baseline and at Week 48.
","['HIV-infected patients with high cardiovascular risk', 'HIV-infected adults aged >50\u2009years or with a Framingham score', 'One hundred and fifty-six patients participated in the ultrasonography and arterial stiffness substudies, respectively']",[],"['Common carotid arteries intima-media thickness (CIMT) and pulse wave velocity (PWV', 'arterial stiffness', 'mean PWV', 'mean progression of both right', 'total cholesterol and other proatherogenic lipid fractions', 'CIMT progression']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}]",[],"[{'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",156.0,0.107148,"Common carotid arteries intima-media thickness (CIMT) and pulse wave velocity (PWV) were measured following a standardized protocol in a subgroup of NEAT022 study participants at baseline and at Week 48.
","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Gonzalez-Cordon', 'Affiliation': 'Hospital Clínic-IDIBAPS, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Lambert', 'Initials': 'L', 'LastName': 'Assoumou', 'Affiliation': ""Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, F75013 Paris, France.""}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Camafort', 'Affiliation': 'Hospital Clínic-IDIBAPS, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Domenech', 'Affiliation': 'Hospital Clínic-IDIBAPS, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Guaraldi', 'Affiliation': 'University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Domingo', 'Affiliation': 'Hospital de Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Rusconi', 'Affiliation': 'DIBIC Luigi Sacco, University of Milan, Milan, Italy.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Raffi', 'Affiliation': 'Hotel-Dieu University Hospital, Nantes, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Katlama', 'Affiliation': 'Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Masia', 'Affiliation': 'Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Bernardino', 'Affiliation': 'Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Saumoy', 'Affiliation': 'Hospital Universitari de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Pozniak', 'Affiliation': 'Chelsea and Westminster Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Gatell', 'Affiliation': 'Hospital Clínic-IDIBAPS, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': 'Hospital Clínic-IDIBAPS, University of Barcelona, Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa292']
1258,32738599,Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial.,"OBJECTIVES


IRX-2 is a primary-cell-derived immune-restorative consisting of multiple human cytokines that act to overcome tumor-mediated immunosuppression and provide an in vivo tumor vaccination to increase tumor infiltrating lymphocytes (TILs). A randomized phase II trial was conducted of the IRX regimen 3 weeks prior to surgery consisting of an initial dose of cyclophosphamide followed by 10 days of regional perilymphatic IRX-2 cytokine injections and daily oral indomethacin, zinc and omeprazole (Regimen 1) compared to the identical regimen without IRX-2 cytokines (Regimen 2).
METHODS


A total of 96 patients with previously untreated, stage II-IV oral cavity SCC were randomized 2:1 to experimental (1) or control (2) regimens (64:32). Paired biopsy and resection specimens from 62 patients were available for creation of tissue microarray (n = 39), and multiplex immunohistology (n = 54). Increases in CD8+ TIL infiltrate scores of at least 10 cells/mm 2  were used to characterize immune responders (IR).
RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2. In p16 negative cancers (n = 26), significant increases in CD8+ and overall TILs were evident in Regimen 1 (p = 0.004, and 0.04 respectively). IRs were more frequent in Regimen 1 (74% vs 31%, p = 0.01). Multiplex immunohistology for PD-L1 expression confirmed an increase in PD-L1 H score for Regimen 1 compared to Regimen 2 (p = 0.11).
CONCLUSIONS


The findings demonstrate significant increases in TILs after perilymphatic IRX-2 injections. Three quarters of patients showed significant immune responses to IRX-2. (NCT02609386).",2020,"RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","['96 patients with previously untreated, stage II-IV oral cavity SCC', 'oral squamous cell carcinoma']","['indomethacin, zinc and omeprazole', 'cyclophosphamide', 'neoadjuvant IRX-2 immunotherapy']","['PD-L1 H score', 'CD8+ TIL infiltrate scores', 'CD8+ infiltrates', 'CD8+ and overall TILs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0585362', 'cui_str': 'Squamous cell carcinoma of mouth'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0758290', 'cui_str': 'IRX 2'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",96.0,0.0184539,"RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","[{'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Wolf', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States. Electronic address: gregwolf@umich.edu.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bellile', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Sartor', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rozek', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Dafydd', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Zarins', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'McHugh', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Oral oncology,['10.1016/j.oraloncology.2020.104928']
1259,32739846,Comparison of topical capsaicin and topical piroxicam in the treatment of acute trauma-induced pain: A randomized double-blind trial.,"BACKGROUND


This study aimed to compare the analgesic efficacy of topical capsaicin and topical piroxicam in acute musculoskeletal injuries.
METHODS


This is a prospective, randomized, controlled, double-blinded study. The data for the 67 patients in the piroxicam group and the 69 in the capsaicin group were examined. The initial visual analog scale (VAS) scores were compared with the 60th and 120th minute as well as the 24th and 72nd hour values. Differences between the VAS scores, clinical effectiveness of the treatment and side effects were evaluated.
RESULTS


In the capsaicin group, the mean difference in the delta VAS scores was significantly higher at each measurement time. The mean of the percentage of reduction in the VAS scores of the topical capsaicin group was significantly higher than that in the topical piroxicam group. The highest difference in terms of both outcomes was determined at the 72nd hour VAS change. Mean differences were 1.53 (95% CI: 0.85-2.221) and 19.7 (95% CI: 12.4-27.2) respectively (p < 0.001). In the capsaicin group, the clinical effect of the treatment was found significantly higher (p < 0.01). The difference between the clinical effectiveness of the groups regarding the treatment outcomes was also statistically significant (p < 0.001). There was no significant difference between the patient groups regarding the presence of side effects.
CONCLUSION


Topical capsaicin can be used as an alternative to topical piroxicam initially and at follow-up in patients presenting to the emergency department with acute pain as there were no observable differences in side-effects between the two groups.",2020,"In the capsaicin group, the clinical effect of the treatment was found significantly higher (p < 0.01).","['patients presenting to the emergency department with acute pain', 'acute musculoskeletal injuries', 'acute trauma-induced pain', '67 patients in the']","['topical capsaicin', 'topical capsaicin and topical piroxicam', 'piroxicam', 'capsaicin', 'Topical capsaicin', 'topical piroxicam']","['VAS scores, clinical effectiveness of the treatment and side effects', 'side effects', 'delta VAS scores', 'analgesic efficacy', 'initial visual analog scale (VAS) scores', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0272448', 'cui_str': 'Injury of musculoskeletal system'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C3210186', 'cui_str': 'Capsaicin-containing product in transdermal dose form'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0031990', 'cui_str': 'Piroxicam'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0861012,"In the capsaicin group, the clinical effect of the treatment was found significantly higher (p < 0.01).","[{'ForeName': 'Abdullah Osman', 'Initials': 'AO', 'LastName': 'Kocak', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey. Electronic address: abdullahmrym86@gmail.com.'}, {'ForeName': 'Sinem', 'Initials': 'S', 'LastName': 'Dogruyol', 'Affiliation': 'Department of Emergency Medicine, Manisa Merkez Efendi State Hospital, Manisa, Turkey.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Akbas', 'Affiliation': 'Department of Emergency Medicine, Bingol State Hospital, Bingol, Turkey.'}, {'ForeName': 'Tugba Sanalp', 'Initials': 'TS', 'LastName': 'Menekse', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Sultan Tuna Akgol', 'Initials': 'STA', 'LastName': 'Gur', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Meryem Betos', 'Initials': 'MB', 'LastName': 'Kocak', 'Affiliation': 'Department of Familiy Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Cekmen', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Karabuk University, Karabuk, Turkey.'}, {'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Orun', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Namik Kemal University, Tekirdağ, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Cakir', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.05.104']
1260,32740807,Use of neoadjuvant versus adjuvant chemotherapy for hormone receptor-positive breast cancer: a National Cancer Database (NCDB) study.,"INTRODUCTION


Neoadjuvant chemotherapy (NAC) is a well-established therapeutic option for patients with locally advanced disease often allowing downstaging and facilitation of breast conserving therapy. With evolution of better targeted treatment regimens and awareness of improved outcomes for significant responders, use of NAC has expanded particularly for triple negative and HER2-positive (HER2+) breast cancer. In this study, we explore utility of neoadjuvant chemotherapy for hormone receptor-positive HER2-negative (HR+ HER2-) patients.
METHODS


Patients with HR+ HER2- breast cancer treated with chemotherapy before or after surgery were identified from 2010 to 2015 in the NCDB. Multivariable regression models adjusted for covariates were used to determine associations within these groups.
RESULTS


Among 134,574 patients (clinical stage 2A, 64%; 2B, 21%; 3, 15%), 105,324 (78%) had adjuvant chemotherapy (AC) and 29,250 (22%) received NAC. Use of NAC increased over time (2010-2015; 13.2-19.4% and PR = 1.34 for 2015; p < 0.0001). Patients were more likely to receive NAC with cT3, cT4, and cN+ disease. Patients less likely to receive NAC were age ≥ 50, lobular carcinoma, increased Charlson-Deyo score, and government insurance. Complete response (pCR) was noted in 8.3% of NAC patients. Axillary downstaging occurred in 21% of patients, and predictors included age < 50 years, black race, poorly differentiated grade, invasive ductal histology, and either ER or PR negativity.
CONCLUSIONS


NAC use among HR+ HER2- breast cancer patients has expanded over time and offers downstaging of disease for some patients, with pCR seen in only a small subset, but downstaging of the axilla in 21%. Further analysis is warranted to determine the subgroup of patients with HR+ HER2- disease who benefit from this approach.",2020,Use of NAC increased over time (2010-2015; 13.2-19.4% and PR = 1.34 for 2015; p < 0.0001).,"['Patients with HR+\u2009HER2- breast cancer treated with chemotherapy before or after surgery were identified from 2010 to 2015 in the NCDB', '134,574 patients (clinical stage 2A, 64%; 2B, 21%; 3, 15%), 105,324 (78%) had adjuvant chemotherapy (AC) and 29,250 (22%) received', 'HR+\u2009HER2- breast cancer patients', 'patients with locally advanced disease', 'hormone receptor-positive breast cancer']","['NAC', 'neoadjuvant versus adjuvant chemotherapy', 'Neoadjuvant chemotherapy (NAC', 'neoadjuvant chemotherapy']","['Complete response (pCR', 'Axillary downstaging']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}]",134574.0,0.0330664,Use of NAC increased over time (2010-2015; 13.2-19.4% and PR = 1.34 for 2015; p < 0.0001).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zeidman', 'Affiliation': 'Mount Sinai Health System, New York, USA. mikezeidman@gmail.com.'}, {'ForeName': 'J Jaime', 'Initials': 'JJ', 'LastName': 'Alberty-Oller', 'Affiliation': 'Mount Sinai Health System, New York, USA.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Ru', 'Affiliation': 'Mount Sinai Health System, New York, USA.'}, {'ForeName': 'Kereeti V', 'Initials': 'KV', 'LastName': 'Pisapati', 'Affiliation': 'Mount Sinai Health System, New York, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Moshier', 'Affiliation': 'Mount Sinai Health System, New York, USA.'}, {'ForeName': 'Soojin', 'Initials': 'S', 'LastName': 'Ahn', 'Affiliation': 'Mount Sinai Health System, New York, USA.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Mazumdar', 'Affiliation': 'Mount Sinai Health System, New York, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Port', 'Affiliation': 'Mount Sinai Health System, New York, USA.'}, {'ForeName': 'Hank', 'Initials': 'H', 'LastName': 'Schmidt', 'Affiliation': 'Mount Sinai Health System, New York, USA.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05809-w']
1261,32748293,Association Between Vomiting and QT Hysteresis: Data from a TQT Study with the Endothelin A Receptor Antagonist Clazosentan.,"This study investigated the potential QT liability of the selective endothelin-1 A receptor antagonist clazosentan at a therapeutic (20 mg/h) and supratherapeutic (60 mg/h) intravenous (i.v.) dose. A randomized, placebo- and moxifloxacin-controlled, double-blind, 3-period, crossover study was conducted in 36 healthy subjects receiving clazosentan (20 mg/h followed by 60 mg/h i.v. for 3 h each), placebo (i.v. for 6 h), and moxifloxacin (single oral dose of 400 mg concomitantly with placebo i.v. for 6 h). At least three replicate ECGs were extracted from Holter recordings at predefined time points from 1 h pre-dose to 24 h after end of infusion. Pharmacokinetic blood sampling was performed for concentration/QT analysis (primary endpoint). For moxifloxacin, the lower bound of the 90% confidence interval (CI) of baseline- and placebo-corrected QTcF (ΔΔQTcF) was > 5 ms at its maximum plasma concentration together with a positive slope of the concentration/QT regression line demonstrating assay sensitivity. For clazosentan, time of peak exposure preceded maximum ΔΔQTcF by 4 h indicating delayed QT-prolonging effects leading to invalidity of the concentration/QT analysis. The secondary by-time-point analysis revealed QT liability of clazosentan (i.e., upper bound of 90% CI ∆∆QTcF > 10 ms). Delayed QT prolongation (i.e., hysteresis) was predominantly observed in subjects with nausea and vomiting, potentially caused by vagal reaction and/or decreases in potassium concentration. By contrast, there was no association with other adverse events, food intake, or concomitant medication. In conclusion, clazosentan at therapeutic and supratherapeutic doses has QT liability with hysteresis effects being associated with nausea and vomiting.",2020,"By contrast, there was no association with other adverse events, food intake, or concomitant medication.",['36 healthy subjects receiving clazosentan (20\xa0mg/h followed by 60\xa0mg/h i.v'],"['moxifloxacin', 'moxifloxacin (single oral dose of 400\xa0mg concomitantly with placebo', 'supratherapeutic', 'placebo']","['adverse events, food intake, or concomitant medication', 'Delayed QT prolongation', 'nausea and vomiting', 'potassium concentration', 'QT liability of clazosentan']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1721268', 'cui_str': 'clazosentan'}, {'cui': 'C0439421', 'cui_str': 'mg/h'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1721268', 'cui_str': 'clazosentan'}]",36.0,0.136815,"By contrast, there was no association with other adverse events, food intake, or concomitant medication.","[{'ForeName': 'Pierre-Eric', 'Initials': 'PE', 'LastName': 'Juif', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123, Allschwil, Switzerland. pierre-eric.juif@idorsia.com.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123, Allschwil, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Voors-Pette', 'Affiliation': 'QPS Netherlands B.V., Groningen, The Netherlands.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Ufer', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123, Allschwil, Switzerland.'}]",The AAPS journal,['10.1208/s12248-020-00485-6']
1262,32751446,Effect of an Integrated Healthcare Program for Korean Rural Older Adults: A Quasi-Experimental Study.,"Studies have been conducted on the development of healthcare programs for older adults in rural areas, not only in Asia but also in Europe and the United States. However, these reports have been limited by largely non-comprehensive results, lack of demand surveys, or programs with no systematic development. The purpose of this study was to develop an integrated healthcare program for rural older adults and investigate the effects of the program. A nonequivalent control group pretest-posttest design was used. Subjects were aged over 65 and lived in the rural community. The integrated healthcare program involved 12 three-hour sessions over 12 weeks. Compared with the control group, the experimental group demonstrated significant differences in both upper extremities strengths (t = 2.74,  p  = 0.008; t = 2.03,  p  = 0.047), static balance (z = -2.38,  p  = 0.017), dynamic balance (t = -4.82,  p  < 0.001), loneliness (t = -3.02,  p  = 0.003), and role self-efficacy (t = 2.39,  p  = 0.020), but no differences for ego integration (t = 1.51,  p  = 0.137). To improve physical, mental, and social health of the rural older adults, we developed an integrated healthcare program. The program improved physical functions, loneliness, and role self-efficiency of the rural older adults. Therefore, it is recommended that healthcare professionals actively apply this program in primary healthcare institutes and elsewhere.",2020,"Compared with the control group, the experimental group demonstrated significant differences in both upper extremities strengths (t = 2.74,  p  = 0.008; t = 2.03,  p  = 0.047), static balance","['rural older adults', 'older adults in rural areas', 'Korean Rural Older Adults', 'Subjects were aged over 65 and lived in the rural community']","['Integrated Healthcare Program', 'integrated healthcare program']","['static balance', 'physical, mental, and social health', 'physical functions, loneliness, and role self-efficiency', 'loneliness', 'upper extremities strengths', 'role self-efficacy', 'dynamic balance']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}]","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",,0.0155838,"Compared with the control group, the experimental group demonstrated significant differences in both upper extremities strengths (t = 2.74,  p  = 0.008; t = 2.03,  p  = 0.047), static balance","[{'ForeName': 'Hyuk Joon', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Research Institute of Nursing Science, College of Nursing, Jeonbuk National University, Jeonju 54896, Korea.'}, {'ForeName': 'Hye Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Research Institute of Nursing Science, College of Nursing, Jeonbuk National University, Jeonju 54896, Korea.'}, {'ForeName': 'Youngran', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Research Institute of Nursing Science, College of Nursing, Jeonbuk National University, Jeonju 54896, Korea.'}, {'ForeName': 'Eun', 'Initials': 'E', 'LastName': 'Ko', 'Affiliation': 'Department of Nursing, College of Life Science and Natural Resources, Sunchon National University, Suncheon 57922, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8030244']
1263,32757413,Non-Motor Symptoms in Parkinson's Disease are Reduced by Nabilone.,"OBJECTIVE


The objective of this study was to assess the efficacy and safety of nabilone, a synthetic tetrahydrocannabinol analogue, as a treatment for non-motor symptoms (NMS) in Parkinson's disease (PD).
METHODS


This was a phase II placebo-controlled, double-blind, parallel-group, enriched enrollment randomized withdrawal trial conducted at the Medical University Innsbruck. A random sample of 47 patients with PD with stable motor disease and disturbing NMS defined by a score of ≥4 points on the Movement Disorder Society - Unified PD Rating Scale-I (MDS-UPDRS-I) underwent open-label nabilone titration (0.25 mg once daily to 1 mg twice daily, phase I). Responders were randomized 1:1 to continue with nabilone or switch to placebo for 4 weeks (phase II). The primary efficacy criterion was the change of the MDS-UPDRS-I between randomization and week 4. Safety was analyzed in all patients who received at least one nabilone dose.
RESULTS


Between October 2017 and July 2019, 19 patients received either nabilone (median dose = 0.75 mg) or placebo. At week 4, mean change of the MDS-UPDRS-I was 2.63 (95% confidence interval [CI] 1.53 to 3.74, p = 0.002, effect size = 1.15) in the placebo versus 1.00 (95% CI -0.16 to 2.16, p = 0.280, effect size = 0.42) in the nabilone-group (difference: 1.63, 95% CI 0.09 to 3.18, p = 0.030, effect size = 0.66). Seventy-seven percent of patients had adverse events (AEs) during open-label titration, most of them were transient. In the double-blind phase, similar proportions of patients in each group had AEs (42% in the placebo group and 32% in the nabilone group). There were no serious AEs.
INTERPRETATION


Our results highlight the potential efficacy of nabilone for patients with PD with disturbing NMS, which appears to be driven by positive effects on anxious mood and night-time sleep problems.
TRIAL REGISTRY


ClinicalTrials.gov (NCT03769896) and EudraCT (2017-000192-86). ANN NEUROL 2020;88:712-722.",2020,"I was 2.63 (95%CI 1.53-3.74, p=0.002, effect","['Between October 2017 and July 2019', '47 PD patients with stable motor disease and disturbing NMS defined by a score of ≥4 points on the Movement Disorder Society-Unified PD Rating Scale-I (MDS-UPDRS-I) underwent', '2017-000192-86', 'non-motor symptoms (NMS) in Parkinson´s Disease (PD']","['nabilone or switch to placebo', 'open-label nabilone titration', 'EudraCT', 'placebo']","['Safety', 'effect', 'mean change of the MDS-UPDRS', 'adverse events (AEs', 'change of the MDS-UPDRS']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}]","[{'cui': 'C0068333', 'cui_str': 'nabilone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.706771,"I was 2.63 (95%CI 1.53-3.74, p=0.002, effect","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Peball', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krismer', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Hans-Günther', 'Initials': 'HG', 'LastName': 'Knaus', 'Affiliation': 'Department for Medical Genetics, Molecular, and Clinical Pharmacology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Atbin', 'Initials': 'A', 'LastName': 'Djamshidian', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Werkmann', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Carbone', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Ellmerer', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Heim', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Marini', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Valent', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Goebel', 'Affiliation': 'Department of Medical Statistics, Informatics, and Health Economics, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Ulmer', 'Affiliation': 'Department of Medical Statistics, Informatics, and Health Economics, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Stockner', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Gregor K', 'Initials': 'GK', 'LastName': 'Wenning', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Raphaela', 'Initials': 'R', 'LastName': 'Stolz', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Krejcy', 'Affiliation': 'AOP Orphan Pharmaceuticals AG, Vienna, Austria.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Poewe', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Seppi', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of neurology,['10.1002/ana.25864']
1264,32759193,Prevention of benign paroxysmal positional vertigo with vitamin D supplementation: A randomized trial.,"OBJECTIVE


To assess the effect of vitamin D and calcium supplementation in preventing recurrences of benign paroxysmal positional vertigo (BPPV).
METHODS


We performed an investigator-initiated, blinded-outcome assessor, parallel, multicenter, randomized controlled trial in 8 hospitals between December 2013 and May 2017. Patients with confirmed BPPV were randomly assigned to the intervention (n = 518) or the observation (n = 532) group after successful treatment with canalith repositioning maneuvers. The primary outcome was the annual recurrence rate (ARR). Patients in the intervention group had taken vitamin D 400 IU and 500 mg of calcium carbonate twice a day for 1 year when serum vitamin D level was lower than 20 ng/mL. Patients in the observation group were assigned to follow-ups without further vitamin D evaluation or supplementation.
RESULTS


The intervention group showed a reduction in the ARR (0.83 [95% confidence interval (CI), 0.74-0.92] vs 1.10 [95% CI, 1.00-1.19] recurrences per 1 person-year) with an incidence rate ratio of 0.76 (95% CI, 0.66-0.87,  p  < 0.001) and an absolute rate ratio of -0.27 (-0.40 to -0.14) from intention-to-treat analysis. The number needed to treat was 3.70 (95% CI, 2.50-7.14). The proportion of patients with recurrence was also lower in the intervention than in the observation group (37.8 vs 46.7%,  p  = 0.005).
CONCLUSIONS


Supplementation of vitamin D and calcium may be considered in patients with frequent attacks of BPPV, especially when serum vitamin D is subnormal.
CLASSIFICATION OF EVIDENCE


This study provides Class III evidence that for patients with BPPV, vitamin D and calcium supplementation reduces recurrences of BPPV.",2020,The intervention group showed a reduction in the ARR [0.83,"['8 hospitals between December 2013 and May 2017', 'patients with frequent attacks of BPPV', 'Patients with confirmed BPPV', 'patients with BPPV']","['vitamin D 400 IU and 500 mg of calcium carbonate', 'Vit D Supplementation', 'vitamin D evaluation or supplementation', 'canalith repositioning maneuvers', 'vitamin D and calcium', 'vitamin D and calcium supplementation']","['proportion of patients with recurrence', 'absolute rate ratio', 'serum vitamin D level', 'annual recurrence rate (ARR', 'recurrences of benign paroxysmal positional vertigo (BPPV']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0155502', 'cui_str': 'Benign paroxysmal positional vertigo'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0155502', 'cui_str': 'Benign paroxysmal positional vertigo'}]",8.0,0.503458,The intervention group showed a reduction in the ARR [0.83,"[{'ForeName': 'Seong-Hae', 'Initials': 'SH', 'LastName': 'Jeong', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Ji-Soo', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital. jisookim@snu.ac.kr.'}, {'ForeName': 'Hyo-Jung', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital. jisookim@snu.ac.kr.'}, {'ForeName': 'Jeong-Yoon', 'Initials': 'JY', 'LastName': 'Choi', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Ja-Won', 'Initials': 'JW', 'LastName': 'Koo', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Kwang-Dong', 'Initials': 'KD', 'LastName': 'Choi', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Ji-Yun', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Seung-Han', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Seo-Young', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Sun-Young', 'Initials': 'SY', 'LastName': 'Oh', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Tae-Ho', 'Initials': 'TH', 'LastName': 'Yang', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Jae Han', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Ileok', 'Initials': 'I', 'LastName': 'Jung', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Soyeon', 'Initials': 'S', 'LastName': 'Ahn', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Sooyeon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital. jisookim@snu.ac.kr.'}]",Neurology,['10.1212/WNL.0000000000010343']
1265,32759203,Randomized controlled trial in support of vitamin D and calcium supplementation for BPPV.,,2020,,[],['Vitamin D and calcium supplementation'],[],[],"[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}]",[],,0.374233,,"[{'ForeName': 'Robin T', 'Initials': 'RT', 'LastName': 'Bigelow', 'Affiliation': 'From the Department of Otolaryngology-Head and Neck Surgery, School of Medicine, Johns Hopkins University, Baltimore, MD. rbigelow@jhmi.edu.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Carey', 'Affiliation': 'From the Department of Otolaryngology-Head and Neck Surgery, School of Medicine, Johns Hopkins University, Baltimore, MD.'}]",Neurology,['10.1212/WNL.0000000000010349']
1266,32762882,A randomized controlled trial of pegylated interferon-alpha with tenofovir disoproxil fumarate for hepatitis B e antigen-negative chronic hepatitis B: A 48-week follow-up study.,"BACKGROUND


Recent studies report incongruent finds regarding the addition of pegylated interferon -alpha (Peg- IFNα) to nucleos(t)ide analogues. This study was designed to compare the efficacy of Peg- IFNα and tenofovir disoproxil fumarate (TDF) combination therapy with each of the treatments separately.
METHODS


In this open-label, randomized clinical trial, treatment-naive hepatitis B e antigen (HBeAg)-negative patients were randomly assigned to three treatment groups: Group A: Peg- IFNα (180 mcg/week) with TDF (300 mg/day); Group B: TDF (300 mg/day); and Group C: Peg- IFNα (180 mcg/week). The intervention spanned 48 weeks and patients were followed up every 12 weeks. The primary end-point was HBV DNA load <20 IU/mL.
RESULTS


Groups A, B and C each comprised of 22, 23 and 22 patients, respectively. The number of patients with HBV DNA suppression in group A was significantly higher compared to groups B and C (P = 0.034). No significant difference was observed in the normalization trends of serum ALT levels between the three groups (P = 0.082). At week 48, combination therapy was significantly more effective in suppressing HBV DNA concentration to below the level of detection than TDF monotherapy (OR = 2.1, 95%CI: 1.18-4.15; P = 0.034). Furthermore, a comparison between monotherapy arms revealed that both interventions had similar effects on the overall outcome (OR = 1.24, 95%CI: 1.02-5.8; P = 0.062).
CONCLUSION


A Peg- IFNα and TDF combination therapy resulted in improved virologic response and was safe in HBeAg negative patients. Monotherapy with Peg-IFNα or TDF procured limited benefits in comparison.
TRIAL REGISTRATION


This study was registered in the Iranian Registry of Clinical Trials (IRCT20181113041635N1).",2020,No significant difference was observed in the normalization trends of serum ALT levels between the three groups (P = 0.082).,"['hepatitis B e antigen-negative chronic hepatitis B', 'treatment-naive hepatitis B e antigen (HBeAg)-negative patients']","['pegylated interferon-alpha with tenofovir disoproxil fumarate', 'TDF', 'Monotherapy with Peg-IFNα or TDF', 'pegylated interferon -alpha', 'TDF combination therapy', 'Peg- IFNα and tenofovir disoproxil fumarate (TDF) combination therapy', 'Peg- IFNα']","['serum ALT levels', 'number of patients with HBV DNA suppression', 'virologic response', 'HBV DNA load <20 IU/mL', 'suppressing HBV DNA concentration']","[{'cui': 'C0948827', 'cui_str': 'Hepatitis B e antigen negative'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0036828', 'cui_str': 'SGPT'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0439458', 'cui_str': 'IU/mL'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.094267,No significant difference was observed in the normalization trends of serum ALT levels between the three groups (P = 0.082).,"[{'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Bahardoust', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran; Department of Epidemiology, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mokhtare', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Barati', 'Affiliation': 'Pediatric Infectious Diseases Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Bagheri-Hosseinabadi', 'Affiliation': 'Department of Clinical Biochemistry, Faculty of Medicine, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Karimi Behnagh', 'Affiliation': 'Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Keyvani', 'Affiliation': 'Department of Virology, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Agah', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran. Electronic address: agah.sh@iums.ac.ir.'}]",Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy,['10.1016/j.jiac.2020.07.005']
1267,32725107,Predictors of recurrence of atrial fibrillation within the first 3 months after ablation.,"AIMS


Freedom from atrial fibrillation (AF) at 1 year can be achieved in 50-70% of patients undergoing catheter ablation. Recurrent AF early after ablation most commonly terminates spontaneously without further interventional treatment but is associated with later recurrent AF. The aim of this investigation is to identify clinical and procedural factors associated with recurrence of AF early after ablation.
METHODS AND RESULTS


We retrospectively analysed data for recurrence of AF within the first 3 months after catheter ablation from the randomized controlled AXAFA-AFNET 5 trial, which demonstrated that continuous anticoagulation with apixaban is as safe and as effective compared to vitamin K antagonists in 678 patients undergoing first AF ablation. The primary outcome of first recurrent AF within 90 days was observed in 163 (28%) patients, in which 78 (48%) patients experienced an event within the first 14 days post-ablation. After multivariable adjustment, a history of stroke/transient ischaemic attack [hazard ratio (HR) 1.54, 95% confidence interval (CI) 0.93-2.6; P = 0.11], coronary artery disease (HR 1.85, 95% CI 1.20-2.86; P = 0.005), cardioversion during ablation (HR 1.78, 95% CI 1.26-2.49; P = 0.001), and an age:sex interaction for older women (HR 1.01, 95% CI 1.00-1.01; P = 0.04) were associated with recurrent AF. The P-wave duration at follow-up was significantly longer for patients with AF recurrence (129 ± 31 ms vs. 122 ± 22 ms in patients without AF, P = 0.03).
CONCLUSION


Half of all early AF recurrences within the first 3 months post-ablation occurred within the first 14 days post-ablation. Vascular disease and cardioversion during the procedure are strong predictors of recurrent AF. P-wave duration at follow-up was longer in patients with recurrent AF.
TRIAL REGISTRATION


Clinicaltrials.gov identifier NCT02227550.",2020,The P-wave duration at follow-up was significantly longer for patients with AF recurrence (129 ± 31 ,"['678 patients undergoing first AF ablation', 'patients with AF recurrence (129\u2009±\u200931']","['apixaban', 'vitamin K antagonists']","['recurrence of atrial fibrillation', 'coronary artery disease', 'Vascular disease and cardioversion', 'history of stroke/transient ischaemic attack', 'first recurrent AF within 90\u2009days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0741282', 'cui_str': 'Recurrent atrial fibrillation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",678.0,0.0706953,The P-wave duration at follow-up was significantly longer for patients with AF recurrence (129 ± 31 ,"[{'ForeName': 'Matthias Daniel', 'Initials': 'MD', 'LastName': 'Zink', 'Affiliation': 'Department of Internal Medicine I, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Winnie', 'Initials': 'W', 'LastName': 'Chua', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Stef', 'Initials': 'S', 'LastName': 'Zeemering', 'Affiliation': 'Department of Physiology, Cardiovascular Research Institute Maastricht (CARIM), Universiteitsingel 50, 6229 ER Maastricht, Netherlands.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'di Biase', 'Affiliation': 'Department of Medicine (Cardiology), Albert Einstein College of Medicine at Montefiore Hospital, Montefiore-Einstein Center for Heart & Vascular Care New York, NY, USA.'}, {'ForeName': 'Bayes de Luna', 'Initials': 'BL', 'LastName': 'Antoni', 'Affiliation': 'Autonomous University of Barcelona and Institut Català Ciències Cardiovasculars (ICCC)-St. Pau Hospital, Barcelona, Spain.'}, {'ForeName': 'Callans', 'Initials': 'C', 'LastName': 'David', 'Affiliation': 'Cardiology Division, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hindricks', 'Affiliation': 'University of Leipzig, Heart Center Leipzig, Leipzig, Germany.'}, {'ForeName': 'Karl Georg', 'Initials': 'KG', 'LastName': 'Haeusler', 'Affiliation': 'Department of Neurology, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Department of Cardiac Electrophysiology, Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Piccini', 'Affiliation': 'Department of Cardiac Electrophysiology, Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Mont', 'Affiliation': 'Arrhythmia Section, Universitat de Barcelona, Hospital Clinic, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Jens Cosedis', 'Initials': 'JC', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Luis Alberto', 'Initials': 'LA', 'LastName': 'Escobar', 'Affiliation': 'Autonomous University of Barcelona and Institut Català Ciències Cardiovasculars (ICCC)-St. Pau Hospital, Barcelona, Spain.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'de Bono', 'Affiliation': 'Department of Cardiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Van Gelder', 'Affiliation': 'Department of Cardiology and Thorax Surgery, UMCG Thorax Center, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'de Potter', 'Affiliation': 'Department of Cardiology, Electrophysiology section, Cardiovascular Center, OLV Hospital, Aalst, Belgium.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Scherr', 'Affiliation': 'Department of Physiology, Cardiovascular Research Institute Maastricht (CARIM), Universiteitsingel 50, 6229 ER Maastricht, Netherlands.'}, {'ForeName': 'Sakis', 'Initials': 'S', 'LastName': 'Themistoclakis', 'Affiliation': ""Unit of Electrophysiology and Cardiac Pacing, Dell'Angelo Hospital, Mestre-Venice, Italy.""}, {'ForeName': 'Derick', 'Initials': 'D', 'LastName': 'Todd', 'Affiliation': 'Department of EP, Devices and ICC, Liverpool Heart and Chest Hospital, Liverpool, UK.'}, {'ForeName': 'Paulus', 'Initials': 'P', 'LastName': 'Kirchhof', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schotten', 'Affiliation': 'Department of Physiology, Cardiovascular Research Institute Maastricht (CARIM), Universiteitsingel 50, 6229 ER Maastricht, Netherlands.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euaa132']
1268,32723187,"Bempegaldesleukin plus nivolumab in untreated, unresectable or metastatic melanoma: Phase III PIVOT IO 001 study design.","Nivolumab, a PD-1 inhibitor, has demonstrated prolonged survival benefit in patients with advanced melanoma. Bempegaldesleukin (BEMPEG; NKTR-214), a first-in-class CD122-preferential IL-2 pathway agonist, provides sustained signaling through the IL-2βγ receptor, which activates effector T and natural killer cells. In the Phase I/II PIVOT-02 trial, the combination of bempegaldesleukin plus nivolumab was well-tolerated and demonstrated clinical activity as first-line therapy in metastatic melanoma. Here, we describe the design of and rationale for the Phase III, global, randomized, open-label PIVOT IO 001 trial comparing bempegaldesleukin plus nivolumab with nivolumab alone in patients with previously untreated, unresectable or metastatic melanoma. Primary end points include objective response rate, progression-free survival and overall survival. Key secondary end points include further investigation of safety/tolerability, previously assessed in the PIVOT-02 trial.  Clinical Trial Registration:  NCT03635983 (ClinicalTrials.gov).",2020,"Primary end points include objective response rate, progression-free survival and overall survival.","['patients with advanced melanoma', 'untreated, unresectable or metastatic melanoma', 'patients with previously untreated, unresectable or metastatic melanoma']","['bempegaldesleukin plus nivolumab with nivolumab alone', 'Bempegaldesleukin plus nivolumab']","['objective response rate, progression-free survival and overall survival', 'safety/tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.541218,"Primary end points include objective response rate, progression-free survival and overall survival.","[{'ForeName': 'Nikhil I', 'Initials': 'NI', 'LastName': 'Khushalani', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL 33612, USA.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Diab', 'Affiliation': 'Department of Melanoma Medical Oncology, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX 77030, USA.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Unit of Medical Oncology and Innovative Therapy, Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale IRCCS, Napoli, Italy.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Department of Medical Oncology, Royal Marsden Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'Peter MacCallum Cancer Centre, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Sznol', 'Affiliation': 'Yale Cancer Center, Yale-New Haven Hospital, New Haven, CT 06511, USA.'}, {'ForeName': 'Henry B', 'Initials': 'HB', 'LastName': 'Koon', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ 08543, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Jarkowski', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ 08543, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ 08543, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Statkevich', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ 08543, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Geese', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ 08543, USA.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Royal North Shore & Mater Hospital, St Leonards, NSW, Australia.'}]","Future oncology (London, England)",['10.2217/fon-2020-0351']
1269,32740976,Alertness Training Improves Spatial Bias and Functional Ability in Spatial Neglect.,"OBJECTIVE


We conducted a multisite, randomized, double-blinded, controlled trial to examine the effectiveness of a digital health intervention targeting the intrinsic regulation of goal-directed alertness in patients with chronic hemispatial neglect.
METHODS


Forty-nine participants with hemispatial neglect, who demonstrated significant spatially biased attention after acquired brain injury, were randomly assigned to the experimental attention remediation treatment or the active control group. The participants engaged with the remotely administered interventions for 12 weeks. The primary outcome was spatial bias on the Posner cueing task (response time difference: left minus right target trials). Secondary outcomes included functional abilities (measured via the Catherine Bergego scale and Barthel index), spatial cognition, executive function, quality of life, and sleep. Assessments were conducted before and immediately after participation in the experimental intervention or control condition, and again after a 3-month no-contact period.
RESULTS


Compared with the active control group, the intervention group exhibited a significant improvement in the primary outcome, a reduction in spatially biased attention on the Posner cueing task (p = 0.010, Cohen's d = 0.96), in addition to significant improvements in functional abilities as measured on the Catherine Bergego and Barthel indices (p = 0.027, Cohen's d = 0.24).
INTERPRETATION


Our results demonstrate that our attention training program was effective in improving the debilitating attention deficits common to hemispatial neglect. This benefit generalized to improvements in real-world functional abilities. This safe, highly scalable, and self-administered treatment for hemispatial neglect might serve as a useful addition to the existing standard of care. ANN NEUROL 2020;88:747-758.",2020,"Compared with the active control group, the intervention group exhibited a significant improvement in the primary outcome-a reduction in spatially biased attention on the Posner cueing task (p=0.010, Cohen's d=0.96)-as well as significant improvements in functional abilities as measured on the Catherine Bergego and Barthel indices (p=0.027, Cohen's d=0.24).
","['patients with chronic hemispatial neglect', 'Forty-nine participants with hemispatial neglect that demonstrated significant spatially biased attention following acquired brain injury']","['experimental attention remediation treatment or active control group', 'digital health intervention', 'Alertness Training']","['spatial bias on the Posner cueing task (response time difference: left - right target trials', 'spatially biased attention on the Posner cueing task', 'Spatial Bias and Functional Ability in Spatial Neglect', 'functional abilities', 'Catherine Bergego and Barthel indices', 'debilitating attention deficits', 'functional abilities (measured via the Catherine Bergego scale and Barthel index), spatial cognition, executive function, quality of life and sleep']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0751421', 'cui_str': 'Hemispatial Neglect'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",49.0,0.274797,"Compared with the active control group, the intervention group exhibited a significant improvement in the primary outcome-a reduction in spatially biased attention on the Posner cueing task (p=0.010, Cohen's d=0.96)-as well as significant improvements in functional abilities as measured on the Catherine Bergego and Barthel indices (p=0.027, Cohen's d=0.24).
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Van Vleet', 'Affiliation': 'Department of Research and Development, Posit Science Inc, San Francisco, CA, USA.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bonato', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Harvard Medical School, Spaulding Rehabilitation Hospital, Boston, MA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Fabara', 'Affiliation': 'Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Sawsan', 'Initials': 'S', 'LastName': 'Dabit', 'Affiliation': 'Department of Research and Development, Posit Science Inc, San Francisco, CA, USA.'}, {'ForeName': 'Sarah-Jane', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Research and Development, Posit Science Inc, San Francisco, CA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chiu', 'Affiliation': 'Department of Psychology, University of Massachusetts, Boston, MA, USA.'}, {'ForeName': 'Antonio Luigi', 'Initials': 'AL', 'LastName': 'Bisogno', 'Affiliation': 'Clinica Neurologica, Department of Neuroscience, and Padova Neuroscience Center (PNC), University of Padova, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Merzenich', 'Affiliation': 'Department of Research and Development, Posit Science Inc, San Francisco, CA, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Corbetta', 'Affiliation': 'Clinica Neurologica, Department of Neuroscience, and Padova Neuroscience Center (PNC), University of Padova, Italy.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'DeGutis', 'Affiliation': 'Boston Attention and Learning Laboratory, VA Boston Healthcare System, Boston, MA, USA.'}]",Annals of neurology,['10.1002/ana.25862']
1270,32753348,Oxidation of dietary linoleate occurs to a greater extent than dietary palmitate in vivo in humans.,"BACKGROUND


It has been suggested that dietary polyunsaturated fatty acids (PUFA) are partitioned into oxidation pathways to a greater extent than dietary saturated fatty acids (SFA). Whilst this has been demonstrated in animal models, evidence in humans is lacking. The potential divergence in the metabolic fate of these dietary fatty acids (FA) may explain some of the reported differences in ectopic fat deposition with SFA and PUFA enriched diets.
AIMS


To compare whole-body oxidation of dietary palmitate and linoleate after consumption of a single test meal.
METHODS


In a randomized, crossover design 24 healthy volunteers (12 males and 12 females, matched for age and BMI) underwent two study days separated by 2-week washout period. During each study day participants consumed a standardized test meal which contained [U 13 C]palmitate or [U 13 C]linoleate. Blood and breath samples were collected over the 6 h postprandial period and the  13 C enrichment in breath CO 2  samples and plasma lipid fractions was determined.
RESULTS


Appearance of  13 C in expired CO 2  was significantly (p < 0.05) increased after consumption of the meal containing [U 13 C]linoleate compared to the meal containing [U 13 C]palmitate. The recovery of tracer was 8.9 ± 1.2% [U 13 C]linoleate vs. 5.6 ± 0.4% [U 13 C]palmitate (p < 0.05). The incorporation of  13 C from [U 13 C]palmitate was greater in plasma triacylglycerol and non-esterified fatty acids than [U 13 C]linoleate, whereas the incorporation of  13 C from [U 13 C]linoleate was greater than [U 13 C]palmitate in plasma phospholipids. Although  13 CO 2  was significantly (p < 0.05) higher in females compared to males after consumption of [U 13 C]palmitate, there was no difference in  13 CO 2  between sexes after consumption of [U 13 C]linoleate.
CONCLUSIONS


We demonstrate that whole-body oxidation of dietary linoleate is comparatively higher than that of dietary palmitate in humans following consumption of a single mixed-test meal. We found indications of sexual dimorphism for dietary palmitate but not dietary linoleate.
STUDY REGISTRATION


http://www.clinicaltrials.org/ ID number NCT03587753.",2020,"RESULTS


Appearance of  13 C in expired CO 2  was significantly (p < 0.05) increased after consumption of the meal containing [U 13 C]linoleate compared to the meal containing [U 13 C]palmitate.","['24 healthy volunteers (12 males and 12 females, matched for age and BMI']","['dietary polyunsaturated fatty acids (PUFA', 'dietary palmitate and linoleate', 'dietary palmitate']","['recovery of tracer', 'Blood and breath samples', 'plasma triacylglycerol and non-esterified fatty acids']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0220871', 'cui_str': 'linoleate'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}]",24.0,0.0206381,"RESULTS


Appearance of  13 C in expired CO 2  was significantly (p < 0.05) increased after consumption of the meal containing [U 13 C]linoleate compared to the meal containing [U 13 C]palmitate.","[{'ForeName': 'Siôn A', 'Initials': 'SA', 'LastName': 'Parry', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Rosqvist', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, UK; Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cornfield', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Barrett', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hodson', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, UK; Oxford NIHR Biomedical Research Centre, Churchill Hospital, Oxford, UK. Electronic address: leanne.hodson@ocdem.ox.ac.uk.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.07.013']
1271,32761316,Using automated pump-delivery devices to reduce the incidence of excessive fluid administration during pediatric dental surgery: a randomized-controlled trial.,"PURPOSE


The harms caused by excessive perioperative intravenous (IV) fluid administration are both well recognized and avoidable. The purpose of this study was to compare the incidence of excess intraoperative fluid administration in pediatric dental surgery patients when either an automated pump-delivery device or a manual gravity-drip device is used.
METHODS


We randomly assigned American Society of Anesthesiologists physical status I and II pediatric dental surgery patients to receive IV fluid via either a manual gravity-drip or automated pump-delivery device. Prior to each case, the attending anesthesiologist determined the target volume of maintenance IV fluid to be administered based on patient weight, estimated fluid deficits, and expected case length. The intraoperative IV fluid delivered was determined at the end of the case by the change in the IV bag weight. The primary outcome was the proportion of procedures that delivered ≥ 10% of the target IV fluid volume.
RESULTS


We recruited 105 children aged two to 12 yr (n = 49 in the automated pump-delivery device; n = 53 in the manual gravity-drip device). The proportion of excessive fluid administration was 8/49 (16%) in the automated pump-delivery device group compared with 33/53 (62%) in the gravity-drip group (relative risk of excessive fluid administration, 0.26; 95% confidence interval, 0.13 to 0.51; P < 0.001).
CONCLUSION


Intraoperative fluid administration using an automated pump-delivery device decreased the incidence of excessive IV fluid administration in pediatric dental surgery patients.
TRIAL REGISTRATION


www.clinicaltrials.gov (NCT03312452); registered 17 October 2017.",2020,"CONCLUSION


Intraoperative fluid administration using an automated pump-delivery device decreased the incidence of excessive IV fluid administration in pediatric dental surgery patients.
","['I and II pediatric dental surgery patients', 'pediatric dental surgery', 'pediatric dental surgery patients', '105 children aged two to 12 yr (n = 49 in the automated pump-delivery device; n = 53 in the manual gravity-drip device']","['IV fluid via either a manual gravity-drip or automated pump-delivery device', 'automated pump-delivery device or a manual gravity-drip device']","['proportion of excessive fluid administration', 'proportion of procedures that delivered ≥ 10% of the target IV fluid volume']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0204324', 'cui_str': 'Dental surgical procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0452837', 'cui_str': 'Dripping'}]","[{'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0452837', 'cui_str': 'Dripping'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",105.0,0.554494,"CONCLUSION


Intraoperative fluid administration using an automated pump-delivery device decreased the incidence of excessive IV fluid administration in pediatric dental surgery patients.
","[{'ForeName': 'Duncan E', 'Initials': 'DE', 'LastName': 'Bowes', 'Affiliation': 'Department of Anesthesiology, Perioperative Medicine and Pain Management, Royal University Hospital, University of Saskatchewan, G525-103 Hospital Drive, Saskatoon, SK, S7N 0W8, Canada. Duncan.Bowes@usask.ca.'}, {'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Gamble', 'Affiliation': 'Department of Anesthesiology, Perioperative Medicine and Pain Management, Royal University Hospital, University of Saskatchewan, G525-103 Hospital Drive, Saskatoon, SK, S7N 0W8, Canada.'}, {'ForeName': 'Jagmeet S', 'Initials': 'JS', 'LastName': 'Bajwa', 'Affiliation': 'Department of Anesthesiology, Perioperative Medicine and Pain Management, Royal University Hospital, University of Saskatchewan, G525-103 Hospital Drive, Saskatoon, SK, S7N 0W8, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01776-4']
1272,32759258,Safety and tolerability of nintedanib in patients with systemic sclerosis-associated interstitial lung disease: data from the SENSCIS trial.,"OBJECTIVES


To characterise the safety and tolerability of nintedanib and the dose adjustments used to manage adverse events in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
METHODS


In the SENSCIS trial, patients with SSc-ILD were randomised to receive nintedanib 150 mg two times per day or placebo. To manage adverse events, treatment could be interrupted or the dose reduced to 100 mg two times per day. We assessed adverse events and dose adjustments over 52 weeks.
RESULTS


A total of 576 patients received nintedanib (n=288) or placebo (n=288). The most common adverse event was diarrhoea, reported in 75.7% of patients in the nintedanib group and 31.6% in the placebo group; diarrhoea led to permanent treatment discontinuation in 6.9% and 0.3% of patients in the nintedanib and placebo groups, respectively. In the nintedanib and placebo groups, respectively, 48.3% and 12.2% of patients had ≥1 dose reduction and/or treatment interruption, and adverse events led to permanent discontinuation of the trial drug in 16.0% and 8.7% of patients. The adverse events associated with nintedanib were similar across subgroups defined by age, sex, race and weight. The rate of decline in forced vital capacity in patients treated with nintedanib was similar irrespective of dose adjustments.
CONCLUSIONS


The adverse event profile of nintedanib in patients with SSc-ILD is consistent with its established safety and tolerability profile in patients with idiopathic pulmonary fibrosis. Dose adjustment is important to minimise the impact of adverse events and help patients remain on therapy.",2020,"The most common adverse event was diarrhoea, reported in 75.7% of patients in the nintedanib group and 31.6% in the placebo group; diarrhoea led to permanent treatment discontinuation in 6.9% and 0.3% of patients in the nintedanib and placebo groups, respectively.","['576 patients received nintedanib (n=288) or', 'patients with systemic sclerosis-associated interstitial lung disease', 'patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD', 'patients with SSc-ILD', 'patients with idiopathic pulmonary fibrosis']","['nintedanib', 'nintedanib 150\u2009mg two times per day or placebo', 'placebo']","['Safety and tolerability', 'safety and tolerability', 'diarrhoea', 'diarrhoea led to permanent treatment discontinuation', 'rate of decline in forced vital capacity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0036429', 'cui_str': 'Sclerosis'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}]","[{'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C3859348', 'cui_str': 'nintedanib 150 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}]",576.0,0.200888,"The most common adverse event was diarrhoea, reported in 75.7% of patients in the nintedanib group and 31.6% in the placebo group; diarrhoea led to permanent treatment discontinuation in 6.9% and 0.3% of patients in the nintedanib and placebo groups, respectively.","[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Seibold', 'Affiliation': 'Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA jamesrseibold@gmail.com.'}, {'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Kristin B', 'Initials': 'KB', 'LastName': 'Highland', 'Affiliation': 'Respiratory Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Assassi', 'Affiliation': 'University of Texas Houston Medical School, Houston, Texas, USA.'}, {'ForeName': 'Arata', 'Initials': 'A', 'LastName': 'Azuma', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Laura Kathleen', 'Initials': 'LK', 'LastName': 'Hummers', 'Affiliation': 'Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Costabel', 'Affiliation': 'Interstitial and Rare Lung Disease Unit, Department of Pneumology, Ruhrlandklinik, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'von Wangenheim', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Kohlbrenner', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, Connecticut, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Gahlemann', 'Affiliation': 'Boehringer Ingelheim (Schweiz) GmbH, Basel, Switzerland.'}, {'ForeName': 'Margarida', 'Initials': 'M', 'LastName': 'Alves', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Distler', 'Affiliation': 'Department of Rheumatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217331']
1273,32744221,Targeting fear of positive evaluation in patients with social anxiety disorder via a brief cognitive behavioural therapy protocol: a proof-of-principle study.,"BACKGROUND


Our aim was to develop a brief cognitive behavioural therapy (CBT) protocol to augment treatment for social anxiety disorder (SAD). This protocol focused specifically upon fear of positive evaluation (FPE). To our knowledge, this is the first protocol that has been designed to systematically target FPE.
AIMS


To test the feasibility of a brief (two-session) CBT protocol for FPE and report proof-of-principle data in the form of effect sizes.
METHOD


Seven patients with a principal diagnosis of SAD were recruited to participate. Following a pre-treatment assessment, patients were randomized to either (a) an immediate CBT condition (n = 3), or (b) a comparable wait-list (WL) period (2 weeks; n = 4). Two WL patients also completed the CBT protocol following the WL period (delayed CBT condition). Patients completed follow-up assessments 1 week after completing the protocol.
RESULTS


A total of five patients completed the brief, FPE-specific CBT protocol (two of the seven patients were wait-listed only and did not complete delayed CBT). All five patients completed the protocol and provided 1-week follow-up data. CBT patients demonstrated large reductions in FPE-related concerns as well as overall social anxiety symptoms, whereas WL patients demonstrated an increase in FPE-related concerns.
CONCLUSIONS


Our brief FPE-specific CBT protocol is feasible to use and was associated with large FPE-specific and social anxiety symptom reductions. To our knowledge, this is the first treatment report that has focused on systematic treatment of FPE in patients with SAD. Our protocol warrants further controlled evaluation.",2020,"CBT patients demonstrated large reductions in FPE-related concerns as well as overall social anxiety symptoms, whereas WL patients demonstrated an increase in FPE-related concerns.
","['Seven patients with a principal diagnosis of SAD were recruited to participate', 'patients with social anxiety disorder via a brief', 'patients with SAD', 'social anxiety disorder (SAD']","['CBT', 'FPE', 'cognitive behavioural therapy protocol', 'immediate CBT condition', 'FPE-specific CBT protocol', 'cognitive behavioural therapy (CBT) protocol']","['FPE-related concerns', 'overall social anxiety symptoms']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",7.0,0.0246387,"CBT patients demonstrated large reductions in FPE-related concerns as well as overall social anxiety symptoms, whereas WL patients demonstrated an increase in FPE-related concerns.
","[{'ForeName': 'Justin W', 'Initials': 'JW', 'LastName': 'Weeks', 'Affiliation': 'Nebraska Medicine, Department of Psychology, University of Nebraska Medical Center, Department of Psychiatry, Omaha, NE68198-4185, USA.'}, {'ForeName': 'M Taylor', 'Initials': 'MT', 'LastName': 'Wilmer', 'Affiliation': 'Adult Anxiety Clinic of Temple, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Carrie M', 'Initials': 'CM', 'LastName': 'Potter', 'Affiliation': 'Adult Anxiety Clinic of Temple, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Waldron', 'Affiliation': 'Adult Anxiety Clinic of Temple, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Versella', 'Affiliation': 'Adult Anxiety Clinic of Temple, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Simona C', 'Initials': 'SC', 'LastName': 'Kaplan', 'Affiliation': 'Adult Anxiety Clinic of Temple, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Dane', 'Initials': 'D', 'LastName': 'Jensen', 'Affiliation': 'Adult Anxiety Clinic of Temple, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Heimberg', 'Affiliation': 'Adult Anxiety Clinic of Temple, Temple University, Philadelphia, PA, USA.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465820000491']
1274,32749863,Treatment With Oral Versus Intravenous Acetaminophen in Elderly Trauma Patients With Rib Fractures: A Prospective Randomized Trial.,"BACKGROUND


Rib fractures are common injuries among traumatically injured patients, and elderly patients with rib fractures are at increased risk for adverse events and death. The purpose of this study was to determine if oral  Per os  (PO) acetaminophen is as effective as intravenous (IV) acetaminophen in treating the pain associated with rib fractures.
METHODS


We performed a single-center, randomized, placebo-controlled, double-blinded study. Trauma patients who were ≥65 years old and had ≥1 rib fracture were included in this study. Patients were randomized into IV acetaminophen and oral placebo (n = 63) or IV placebo and oral solution acetaminophen (n = 75) groups. The primary outcome was a mean reduction in pain score at 24 hours, and secondary outcomes included opioid use, intensive care unit (ICU) length of stay (LOS), hospital LOS, hospital mortality, the difference in incentive spirometry, and development of pneumonia.
RESULTS


Among the 138 patients included, there was no statistically significant difference between the 2 study groups in a mean reduction in pain score at 24 hours after injury (PO: 3.24, IV: 2.49;  P  = .230). Opioid pain medication use was equivalent between groups ( P  = .212), and there was no significant difference in hospital mortality rate between groups ( P  = .827). There was no statistically significant difference in ICU LOS, hospital LOS, or development of pneumonia.
DISCUSSION


In elderly trauma patients (age ≥65 years) with 1 or more rib fractures, PO acetaminophen is equivalent to IV acetaminophen for pain control, with no difference in morbidity or mortality. Oral acetaminophen should be preferentially used over IV acetaminophen when treating the elderly trauma patient with rib fractures.",2020,"Among the 138 patients included, there was no statistically significant difference between the 2 study groups in a mean reduction in pain score at 24 hours after injury (PO: 3.24, IV: 2.49;  P  = .230).","['elderly trauma patient with rib fractures', 'elderly trauma patients (age ≥65 years) with 1 or more rib fractures', 'Trauma patients who were ≥65 years old and had ≥1 rib fracture', '138 patients', 'Elderly Trauma Patients With Rib Fractures', 'traumatically injured patients, and elderly patients with rib fractures']","['PO acetaminophen', 'oral  Per os  (PO) acetaminophen', 'Oral Versus Intravenous Acetaminophen', 'placebo and oral solution acetaminophen', 'acetaminophen and oral placebo', 'acetaminophen', 'Oral acetaminophen', 'placebo']","['hospital mortality rate', 'morbidity or mortality', 'opioid use, intensive care unit (ICU) length of stay (LOS), hospital LOS, hospital mortality, the difference in incentive spirometry, and development of pneumonia', 'mean reduction in pain score', 'ICU LOS, hospital LOS, or development of pneumonia', 'pain score', 'Opioid pain medication use']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035522', 'cui_str': 'Fracture of rib'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}]","[{'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0454512', 'cui_str': 'Incentive spirometry'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",138.0,0.177722,"Among the 138 patients included, there was no statistically significant difference between the 2 study groups in a mean reduction in pain score at 24 hours after injury (PO: 3.24, IV: 2.49;  P  = .230).","[{'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Antill', 'Affiliation': '21823 Department of Surgery, University of Tennessee Medical Center, Knoxville, TN, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Frye', 'Affiliation': 'Department of Pharmacy, Spartanburg Medical Center, SC, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'McMillen', 'Affiliation': 'Department of Pharmacy, University of Tennessee Medical Center, Knoxville, TN, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Haynes', 'Affiliation': 'Department of Surgery, WellStar North Fulton Hospital, Roswell, GA, USA.'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Ford', 'Affiliation': 'Department of Surgery, Roper Saint Francis Healthcare, Charleston, SC, USA.'}, {'ForeName': 'Reagan W', 'Initials': 'RW', 'LastName': 'Bollig', 'Affiliation': '21823 Department of Surgery, University of Tennessee Medical Center, Knoxville, TN, USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Daley', 'Affiliation': '21823 Department of Surgery, University of Tennessee Medical Center, Knoxville, TN, USA.'}]",The American surgeon,['10.1177/0003134820940268']
1275,32758672,Beneficial Effects of Role Reversal in Comparison to role-playing on negative cognitions about Other's Judgments for Social Anxiety Disorder.,"BACKGROUND AND OBJECTIVES


Negative beliefs about other's judgments play an important role in the development and maintenance of social anxiety disorder. The present experiment examined the effects of role-playing followed by role reversal compared to role-playing twice on altering these negative cognitions.
METHODS


Thirty-six adult social anxiety patients were randomized into two conditions: a role-playing condition in which 18 participants role-played an anxiety-provoking social situation twice, or a role reversal condition in which 18 participants role-played an anxiety-provoking social situation followed by enacting the same situation using role reversal. Before the start of the experiment, patients were asked to report their negative cognitions about the other's judgments. Next, they were asked to rate the believability of these negative cognitions, as well as the probability and cost estimates of negative judgments by the other person, at three time-points: before the first block of role-playing, after the first block of role-playing, and after the second block of the experiment.
RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
LIMITATIONS


The most important limitation of the present study is that there was no control group to assess the effects of role-playing alone. Moreover, the second block of the experiment was repetitive in role-playing, however, it was a new task in role reversal.
CONCLUSIONS


The results support the hypothesis that role reversal is an effective technique that can be used to correct negative cognitions about other's judgments in SAD.",2020,"RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
","['Thirty-six adult social anxiety patients', ""negative cognitions about Other's Judgments for Social Anxiety Disorder""]","['role-playing condition in which 18 participants role-played an anxiety-provoking social situation twice, or a role reversal condition in which 18 participants role-played an anxiety-provoking social situation followed by enacting the same situation using role reversal']",[],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]","[{'cui': 'C0035822', 'cui_str': 'Role play technique'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",[],36.0,0.0134432,"RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
","[{'ForeName': 'Hanieh', 'Initials': 'H', 'LastName': 'Abeditehrani', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands. Electronic address: H.Abeditehrani@uva.nl.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Dijk', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands.'}, {'ForeName': 'Mohsen Dehghani', 'Initials': 'MD', 'LastName': 'Neyshabouri', 'Affiliation': 'University of Social Welfare and Rehabilitation Sciences, Department of Clinical Psychology, Tehran, Iran.'}, {'ForeName': 'Arnoud', 'Initials': 'A', 'LastName': 'Arntz', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101599']
1276,32760093,Pain during pars plana vitrectomy following sub-Tenon versus peribulbar anesthesia: A randomized trial.,"PURPOSE


To compare pain during pars plana vitrectomy (PPV) following topical lidocaine jelly and sub-Tenon anesthesia versus peribulbar anesthesia.
METHODS


Prospective, single-center, randomized study. Patients scheduled for PPV for macular hole (MH) or epiretinal membrane (ERM) at the Retina and Vitreous Section of the Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo were randomly assigned to one of two groups in a 1:1 allocation ratio. Patients assigned to Group ST received topical anesthesia with 2% lidocaine jelly followed by sub-Tenon anesthesia with 2-4 ml of 1% ropivacaine. Patients assigned to PB received peribulbar anesthesia with 4-6 ml of 1% ropivacaine. After PPV, patients in both groups were asked to rate the level of pain they felt during the entire procedure (including anesthesia administration and PPV) by pointing at a 0-100 Visual Analogue Pain Scale (VAS). Data regarding demographics, patient characteristics and surgical features were also collected.
RESULTS


Fifty-four patients were enrolled in the study (26 in Group ST and 28 in Group PB). Baseline characteristics, including age, gender, and presence of comorbidities, were similar in both groups. The surgery performed was PPV alone in 10 and 14 patients in the ST and PB groups, respectively, and combined phacoemulsification and PPV in 16 and 14 patients in the ST and PB groups, respectively (p = 0.39, Pearson). Surgery duration (mean ± SD minutes) was similar in the two groups (62 ± 12 for ST and 70 ± 20 for PB, p = 0.09, t-Test). No patients needed supplemental topical or intravenous anesthesia during surgery. No sight- or life-threatening complication was observed in either group. VAS score was significantly lower in the ST compared to the PB group (median (interquartile range) was 1 (2.25-0) in the ST group compared to 11.5 (29.75-5) in the PB group, p< 0.0001, Wilcoxon).
CONCLUSION


In this study of patients who underwent PPV for MH or ERM, topical followed by sub-Tenon anesthesia was more effective in controlling pain during the whole vitrectomy procedure than peribulbar anesthesia. Compared to peribulbar anesthesia which is administered with a sharp needle, sub-Tenon anesthesia administered with a blunt cannula may be associated with a reduced risk of such adverse events as globe perforation, retrobulbar hemorrhage, and inadvertent injection of anesthesia into the optic nerve sheath.",2020,No sight- or life-threatening complication was observed in either group.,"['Fifty-four patients were enrolled in the study (26 in Group ST and 28 in Group PB', 'Patients scheduled for PPV for macular hole (MH) or epiretinal membrane (ERM) at the Retina and Vitreous Section of the Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo', 'patients who underwent PPV for MH or']","['pars plana vitrectomy following sub-Tenon versus peribulbar anesthesia', 'peribulbar anesthesia', 'ERM, topical followed by sub-Tenon anesthesia', 'pars plana vitrectomy (PPV', 'topical anesthesia with 2% lidocaine jelly followed by sub-Tenon anesthesia with 2-4 ml of 1% ropivacaine', 'peribulbar anesthesia with 4-6 ml of 1% ropivacaine', 'topical lidocaine jelly and sub-Tenon anesthesia']","['VAS score', 'sight- or life-threatening complication', 'Pain', 'Surgery duration (mean ± SD minutes', 'Visual Analogue Pain Scale (VAS']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0024441', 'cui_str': 'Macular hole'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0036378', 'cui_str': 'Medical School'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0472473', 'cui_str': 'Topical local anesthetic'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439232', 'cui_str': 'min'}]",54.0,0.0335394,No sight- or life-threatening complication was observed in either group.,"[{'ForeName': 'Jefferson A S', 'Initials': 'JAS', 'LastName': 'Ribeiro', 'Affiliation': 'Superior School of Health Sciences, Amazonas State University, Manaus, AM, Brazil.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Ingrid U', 'Initials': 'IU', 'LastName': 'Scott', 'Affiliation': 'Department of Ophthalmology, Penn State College of Medicine, Hershey, Pennsylvania, United States of America.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Abrão', 'Affiliation': 'Department of Biomechanics, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Jorge', 'Affiliation': 'Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}]",PloS one,['10.1371/journal.pone.0236624']
1277,32764524,Associations of Lifestyle Intervention Effect with Blood Pressure and Physical Activity among Community-Dwelling Older Americans with Hypertension in Southern California.,"A healthy lifestyle and regular physical activity are highly recommended for older adults. However, there has been limited research into testing lifestyle intervention effects on physical activity in older adults with hypertension. The purpose of this study was to assess the association of lifestyle intervention effects with physical activity and blood pressure in older adults with hypertension, accounting for social support and perceived stress as control variables. This study performed a secondary analysis of a two-arm randomized controlled trial. A total of 196 participants were randomly assigned to a six-month lifestyle intervention group or a control group. Hierarchical multiple regression analyses demonstrated that lifestyle intervention effects were not significantly associated with improvements in physical activity and blood pressure, but the final regression models were statistically significant (all  p  < 0.001). The result revealed that only physical activity frequency at baseline was significantly related to improvement in physical activity. Systolic blood pressure (SBP) at baseline and monthly income were significantly associated with change in SBP, while age and diastolic blood pressure (DBP) at baseline were significantly related to change in DBP. The findings provide empirical evidence for developing and optimizing lifestyle interventions for future research and clinical practice in this population.",2020,"Hierarchical multiple regression analyses demonstrated that lifestyle intervention effects were not significantly associated with improvements in physical activity and blood pressure, but the final regression models were statistically significant (all  p  < 0.001).","['older adults with hypertension', 'Community-Dwelling Older Americans with Hypertension in Southern California', 'A total of 196 participants', 'older adults']","['lifestyle intervention group or a control group', 'physical activity and blood pressure', 'Blood Pressure and Physical Activity']","['physical activity frequency', 'physical activity', 'physical activity and blood pressure', 'Systolic blood pressure (SBP', 'diastolic blood pressure (DBP']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517625', 'cui_str': '196'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",196.0,0.0192055,"Hierarchical multiple regression analyses demonstrated that lifestyle intervention effects were not significantly associated with improvements in physical activity and blood pressure, but the final regression models were statistically significant (all  p  < 0.001).","[{'ForeName': 'Mei-Lan', 'Initials': 'ML', 'LastName': 'Chen', 'Affiliation': 'Byrdine F. Lewis College of Nursing and Health Professions, Georgia State University, Atlanta, GA 30303, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'College of Nursing, The Ohio State University, Columbus, OH 43210, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'McCoy', 'Affiliation': 'School of Nursing, University of North Carolina at Greensboro, Greensboro, NC 27402, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Letvak', 'Affiliation': 'School of Nursing, University of North Carolina at Greensboro, Greensboro, NC 27402, USA.'}, {'ForeName': 'Luba', 'Initials': 'L', 'LastName': 'Ivanov', 'Affiliation': 'College of Nursing, Chamberlain University, Downers Grove, IL 60515, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17165673']
1278,32772246,Increased fascicle length but not patellar tendon stiffness after accentuated eccentric-load strength training in already-trained men.,"PURPOSE


This study examined whether additional external load during the eccentric phase of lower limb strength training exercises led to greater adaptations in knee extensor strength, muscle architecture, and patellar tendon properties than traditional concentric-eccentric training in already-trained men.
METHODS


Twenty-eight men accustomed to strength training were randomized to undertake 10 weeks of supervised traditional (TRAD) or accentuated eccentric loading (AEL) or continue their habitual unsupervised (CON) strength training. TRAD and AEL trained 2∙week -1  with a six-repetition maximum (RM) session and a ten-RM session. TRAD used the same external load in both concentric and eccentric phases, while AEL used 40% greater load during the eccentric than concentric phase. Tests were performed at pre- and post-training, including: maximum unilateral isokinetic (30°·s -1 ) concentric, eccentric and isometric torques by isokinetic dynamometry, unilateral isometric ramp contractions with muscle-tendon ultrasound imaging to measure tendon stiffness and hysteresis, and resting vastus lateralis and medialis fascicle angle and length measured by extended-field-of-view ultrasound.
RESULTS


After training, both TRAD and AEL significantly increased maximum concentric and isometric torque (p < 0.05), but only AEL increased eccentric torque (AEL: + 10 ± 9%, TRAD: + 4 ± 9%) and vastus lateralis (AEL: + 14 ± 14%, TRAD: + 1 ± 10%) and medialis (AEL: + 19 ± 8%, TRAD: + 5 ± 11%) fascicle length.
CONCLUSION


Both TRAD and AEL increased maximum knee extensor strength but only AEL increased VL and VM fascicle length. Neither training program promoted changes in fascicle angle or changes in patellar tendon properties in our already-trained men.",2020,"After training, both TRAD and AEL significantly increased maximum concentric and isometric torque (p < 0.05), but only AEL increased eccentric torque (AEL: + 10 ± 9%, TRAD: + 4 ± 9%) and vastus lateralis (AEL: + 14 ± 14%, TRAD: + 1 ± 10%) and medialis (AEL: + 19 ± 8%, TRAD: + 5 ± 11%) fascicle length.
CONCLUSION


","['already-trained men', 'Twenty-eight men accustomed to strength training']","['supervised traditional (TRAD) or accentuated eccentric loading (AEL) or continue their habitual unsupervised (CON) strength training', 'maximum unilateral isokinetic (30°·s -1 ) concentric, eccentric and isometric torques by isokinetic dynamometry, unilateral isometric ramp contractions with muscle-tendon ultrasound imaging to measure tendon stiffness and hysteresis, and resting vastus lateralis and medialis fascicle angle and length measured by extended-field-of-view ultrasound', 'traditional concentric-eccentric training']","['maximum knee extensor strength', 'eccentric torque (AEL', 'maximum concentric and isometric torque', 'Increased fascicle length', 'fascicle angle or changes in patellar tendon properties', 'knee extensor strength, muscle architecture, and patellar tendon properties', 'VL and VM fascicle length']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1997416', 'cui_str': 'Accentuated'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}]",,0.0128459,"After training, both TRAD and AEL significantly increased maximum concentric and isometric torque (p < 0.05), but only AEL increased eccentric torque (AEL: + 10 ± 9%, TRAD: + 4 ± 9%) and vastus lateralis (AEL: + 14 ± 14%, TRAD: + 1 ± 10%) and medialis (AEL: + 19 ± 8%, TRAD: + 5 ± 11%) fascicle length.
CONCLUSION


","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'NeuroMuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Room VIV223, 40014, Jyväskylä, Finland. simon.walker@jyu.fi.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Trezise', 'Affiliation': 'School of Medical and Health Sciences, Centre for Exercise and Sports Science Research, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Guy Gregory', 'Initials': 'GG', 'LastName': 'Haff', 'Affiliation': 'School of Medical and Health Sciences, Centre for Exercise and Sports Science Research, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Robert U', 'Initials': 'RU', 'LastName': 'Newton', 'Affiliation': 'School of Medical and Health Sciences, Centre for Exercise and Sports Science Research, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Keijo', 'Initials': 'K', 'LastName': 'Häkkinen', 'Affiliation': 'NeuroMuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Room VIV223, 40014, Jyväskylä, Finland.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Blazevich', 'Affiliation': 'School of Medical and Health Sciences, Centre for Exercise and Sports Science Research, Edith Cowan University, Joondalup, WA, Australia.'}]",European journal of applied physiology,['10.1007/s00421-020-04462-x']
1279,32772268,PICSI vs. MACS for abnormal sperm DNA fragmentation ICSI cases: a prospective randomized trial.,"PURPOSE


To know which sperm selection technique, physiological intracytoplasmic sperm injection (PICSI) or magnetic-activated cell sorting (MACS), is better for the selection of sperm with abnormal sperm DNA fragmentation (SDF) in patients undergoing intracytoplasmic sperm injection (ICSI).
METHODS


A prospective randomized trial included 413 ICSI cases with abnormal SDF (> 20.3%) by TUNEL assay. Patients with at least 1 million total progressive motile sperm count were randomized to PICSI or MACS groups on the day of ICSI. PICSI depends on the hyaluronan binding of better SDF sperm where individual sperm was selected, while MACS selects non-apoptotic sperm population using Annexin V magnetic beads. All pre-implantation embryogenic parameters were observed and the main outcome was the ongoing pregnancy rate.
RESULTS


There were no significant differences between patients allocated to PICSI and MACS in the studied parameters including pre-implantation embryological data, implantation, clinical pregnancy, and ongoing pregnancy rates. Meanwhile, sub-analysis according to the female age has shown that female patients with less than 30 years of age in the MACS group had significantly higher good-quality blastocyst, clinical pregnancy, and ongoing pregnancy rates than the PICSI group. However, the higher implantation (p = 0.051), clinical pregnancy (p = 0.078), and ongoing pregnancy (p = 0.097) rates observed in females between 30 and 35 years of age in the PICSI group did not reach significance level.
CONCLUSIONS


PICSI and MACS are efficient techniques for sperm selection in cases with abnormal sperm DNA fragmentation. However, MACS is preferred when the females are younger than 30 years, while PICSI is preferred in older females.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03398317 (retrospectively registered).",2020,"There were no significant differences between patients allocated to PICSI and MACS in the studied parameters including pre-implantation embryological data, implantation, clinical pregnancy, and ongoing pregnancy rates.","['Patients with at least 1 million total progressive motile sperm count', '413 ICSI cases with abnormal SDF (>\u200920.3%) by TUNEL assay', 'patients undergoing intracytoplasmic sperm injection (ICSI', 'female patients with less than 30\xa0years of age in the']","['physiological intracytoplasmic sperm injection (PICSI) or magnetic-activated cell sorting ', 'PICSI or MACS', 'PICSI and MACS', 'PICSI vs. MACS', 'MACS']","['ongoing pregnancy', 'good-quality blastocyst, clinical pregnancy, and ongoing pregnancy rates', 'pre-implantation embryological data, implantation, clinical pregnancy, and ongoing pregnancy rates', 'clinical pregnancy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0600528', 'cui_str': 'In Situ Nick End Labeling'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0007616', 'cui_str': 'Cell Isolation'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",413.0,0.0907136,"There were no significant differences between patients allocated to PICSI and MACS in the studied parameters including pre-implantation embryological data, implantation, clinical pregnancy, and ongoing pregnancy rates.","[{'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Hasanen', 'Affiliation': 'IVF Laboratory, Ganin Fertility Center, Cairo, 11728, Egypt. em.saberh@gmail.com.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Elqusi', 'Affiliation': 'IVF Laboratory, Ganin Fertility Center, Cairo, 11728, Egypt.'}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'ElTanbouly', 'Affiliation': 'IVF Laboratory, Ganin Fertility Center, Cairo, 11728, Egypt.'}, {'ForeName': 'Abd ElGhafar', 'Initials': 'AE', 'LastName': 'Hussin', 'Affiliation': 'IVF Laboratory, Ganin Fertility Center, Cairo, 11728, Egypt.'}, {'ForeName': 'Hanaa', 'Initials': 'H', 'LastName': 'AlKhadr', 'Affiliation': 'IVF Laboratory, Ganin Fertility Center, Cairo, 11728, Egypt.'}, {'ForeName': 'Hosam', 'Initials': 'H', 'LastName': 'Zaki', 'Affiliation': 'IVF Laboratory, Ganin Fertility Center, Cairo, 11728, Egypt.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Henkel', 'Affiliation': 'University of the Western Cape, Cape Town, South Africa.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'American Center for Reproductive Medicine, Cleveland Clinic, Cleveland, OH, USA.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-020-01913-4']
1280,32739411,Apple polyphenol-rich drinks dose-dependently decrease early-phase postprandial glucose concentrations following a high-carbohydrate meal: a randomized controlled trial in healthy adults and in vitro studies.,"BACKGROUND


Previous research demonstrated that a high dose of phlorizin-rich apple extract (AE) can markedly inhibit early-phase postprandial glycemia, but efficacy of lower doses of the AE is unclear.
OBJECTIVE


To determine whether lower AE doses reduce early-phase postprandial glycemia in healthy adults and investigate mechanisms.
DESIGN


In a randomized, controlled, double-blinded, cross-over acute trial, drinks containing 1.8 g (HIGH), 1.35 g (MED), 0.9 g (LOW), or 0 g (CON) of a phlorizin-rich AE were consumed before 75 g starch/sucrose meal. Postprandial blood glucose, insulin, C-peptide, glucose-dependent insulinotropic polypeptide (GIP) and polyphenol metabolites concentrations were measured 0-240 min, acetaminophen concentrations to assess gastric emptying rate, and 24 h urinary glucose excretion. Effects of AE on intestinal glucose transport were investigated in Caco-2/TC7 cells.
RESULTS


AE significantly reduced plasma glucose iAUC 0-30 min at all doses: mean differences (95% CI) relative to CON were -15.6 (-23.3, -7.9), -11.3 (-19.6, -3.0) and -8.99 (-17.3, -0.7) mmol/L per minute for HIGH, MEDIUM and LOW respectively, delayed T max  (HIGH, MEDIUM and LOW 45 min vs. CON 30 min), but did not lower C max . Similar dose-dependent treatment effects were observed for insulin, C-peptide, and GIP. Gastric emptying rates and urinary glucose excretion did not differ. Serum phloretin, quercetin and epicatechin metabolites were detected postprandially. A HIGH physiological AE dose equivalent decreased total glucose uptake by 48% in Caco-2/TC7 cells.
CONCLUSIONS


Phlorizin-rich AE, even at a low dose, can slightly delay early-phase glycemia without affecting peak and total glycemic response.",2020,"RESULTS


AE significantly reduced plasma glucose iAUC 0-30 min at all doses: mean differences (95% CI) relative to CON were-15.6 (-23.3, -7.9), -11.3 (-19.6, -3.0)",['healthy adults'],"['Apple polyphenol-rich drinks', 'phlorizin-rich apple extract (AE', 'AE', 'phlorizin-rich AE were consumed before 75 g starch/sucrose meal']","['Postprandial blood glucose, insulin, C-peptide, glucose-dependent insulinotropic polypeptide (GIP) and polyphenol metabolites concentrations', 'gastric emptying rate, and 24 h urinary glucose excretion', 'total glucose uptake', 'Serum phloretin, quercetin and epicatechin metabolites', 'Gastric emptying rates and urinary glucose excretion', 'total glycaemic response', 'insulin, C-peptide, and GIP', 'early-phase postprandial glucose concentrations', 'plasma glucose iAUC', 'delayed T max  ', 'intestinal glucose transport']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0031562', 'cui_str': 'Phlorhizin'}, {'cui': 'C3257517', 'cui_str': 'Apple extract'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031560', 'cui_str': 'Phloretin'}, {'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C0014485', 'cui_str': '(-)-Epicatechin'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}]",,0.233603,"RESULTS


AE significantly reduced plasma glucose iAUC 0-30 min at all doses: mean differences (95% CI) relative to CON were-15.6 (-23.3, -7.9), -11.3 (-19.6, -3.0)","[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Prpa', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Corpe', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Atkinson', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Blackstone', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Leftley', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Parekh', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Philo', 'Affiliation': 'Quadram Institute Bioscience, Norwich Research Park, Norwich, UK.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Kroon', 'Affiliation': 'Quadram Institute Bioscience, Norwich Research Park, Norwich, UK.'}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Hall', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK. Electronic address: wendy.hall@kcl.ac.uk.""}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2020.108466']
1281,32740676,Effect of lurasidone versus olanzapine on cardiometabolic parameters in unmedicated patients with schizophrenia: a randomized controlled trial.,"OBJECTIVE


Patients with schizophrenia are at higher risk of cardiovascular morbidity and mortality than healthy individuals. This study was conducted to compare the effect of lurasidone and olanzapine on cardiometabolic parameters in unmedicated patients with schizophrenia.
METHODS


The present study was a randomized open-label, parallel design, active-controlled clinical trial. After recruitment and randomization of 101 patients, a baseline assessment was done by PANSS, SOFAS, lipid profile, fasting blood glucose, HbA 1c , serum insulin and serum hs-CRP. HOMA-IR, atherogenic index, coronary risk index and cardiovascular risk indices were calculated as derived parameters. Patients received either lurasidone 80 mg or olanzapine 10 mg as monotherapy and followed up after 6 weeks.
RESULTS


There was a significant increase in fasting blood glucose (p < 0.001), HbA 1c  (p < 0.001) and serum insulin (p < 0.001) after 6 weeks of therapy in both the treatment groups but the difference between the groups was not significant (FBS, p = 0.209; HbA1c, p = 0.209; serum insulin, p = 0.720). Olanzapine showed worsening of lipid profile (p < 0.001) while the same improved with lurasidone (p < 0.001) and the difference between the groups was found to be significant (p < 0.001). Serum HDL level decreased in both the treatment groups (olanzapine, p < 0.001; lurasidone, p < 0.001) but the difference between the groups was not significant (p = 0.333). There was an increase in hs-CRP levels in both the treatment groups (olanzapine, p < 0.001; lurasidone, p < 0.001) with no significant difference between them (p = 0.467). Atherogenic index, coronary risk index and cardiovascular risk index increased significantly in the olanzapine group as compared with the lurasidone group (p < 0.001).
CONCLUSION


Lurasidone showed a favourable effect on lipid profile and cardiovascular risk indices over olanzapine. However, long-term studies are needed to establish and generalize the findings.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03304457.",2020,"There was a significant increase in fasting blood glucose (p < 0.001), HbA 1c  (p < 0.001) and serum insulin (p < 0.001) after 6 weeks of therapy in both the treatment groups but the difference between the groups was not significant (FBS, p = 0.209; HbA1c, p = 0.209; serum insulin, p = 0.720).","['unmedicated patients with schizophrenia', 'Patients with schizophrenia']","['olanzapine', 'lurasidone', 'Olanzapine', 'lurasidone and olanzapine', 'lurasidone 80 mg or olanzapine 10 mg as monotherapy']","['fasting blood glucose', 'cardiometabolic parameters', 'serum insulin', 'Serum HDL level', 'Atherogenic index, coronary risk index and cardiovascular risk index', 'lipid profile and cardiovascular risk indices', 'PANSS, SOFAS, lipid profile, fasting blood glucose, HbA 1c , serum insulin and serum hs-CRP', 'cardiovascular morbidity and mortality', 'hs-CRP levels', 'HOMA-IR, atherogenic index, coronary risk index and cardiovascular risk indices', 'worsening of lipid profile']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0988260', 'cui_str': 'olanzapine 10 MG'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}]",101.0,0.0355811,"There was a significant increase in fasting blood glucose (p < 0.001), HbA 1c  (p < 0.001) and serum insulin (p < 0.001) after 6 weeks of therapy in both the treatment groups but the difference between the groups was not significant (FBS, p = 0.209; HbA1c, p = 0.209; serum insulin, p = 0.720).","[{'ForeName': 'Monalisa', 'Initials': 'M', 'LastName': 'Jena', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Mishra', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Biswa Ranjan', 'Initials': 'BR', 'LastName': 'Mishra', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India.'}, {'ForeName': 'Santanu', 'Initials': 'S', 'LastName': 'Nath', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India.'}, {'ForeName': 'Rituparna', 'Initials': 'R', 'LastName': 'Maiti', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India. pharm_rituparna@aiimsbhubaneswar.edu.in.'}]",Psychopharmacology,['10.1007/s00213-020-05628-3']
1282,32747522,Effect of fremanezumab on quality of life and productivity in patients with chronic migraine.,"OBJECTIVE


To evaluate fremanezumab quarterly or monthly vs placebo on health-related quality of life, health status, patients' global impression of change, and productivity in patients with chronic migraine (CM).
METHODS


HALO CM was a double-blind, placebo-controlled trial in patients with CM. Patients were randomized 1:1:1 to treatment with fremanezumab quarterly (675 mg at baseline, placebo at weeks 4 and 8), fremanezumab monthly (225 mg at baseline, weeks 4 and 8), or placebo. This article assessed the effect of treatment with fremanezumab on health-related quality of life and productivity using the following prespecified assessments: the Migraine-Specific Quality of Life (MSQoL) questionnaire at baseline and weeks 4, 8, and 12; Patient Global Impression of Change (PGIC) questionnaire at weeks 4, 8, and 12; and EuroQoL 5-dimension, 5-response level (EQ-5D-5L) questionnaire and Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire at baseline and week 12.
RESULTS


The full analysis set included 1,121 patients: 375 patients with quarterly dosing, 375 with monthly dosing, and 371 with placebo. Fremanezumab quarterly and monthly was associated with significant improvements over placebo in change from baseline mean scores in MSQoL domains (all,  p  < 0.05) to week 12. At week 12, fremanezumab also showed significant improvements in EQ-5D-5L visual analog scale ( p  < 0.05) and PGIC scores ( p  < 0.0001) as well as significant reductions from baseline in WPAI:GH scores ( p  < 0.01) and presenteeism (impairment while working;  p  < 0.05) vs placebo.
CONCLUSIONS


Fremanezumab quarterly or monthly was associated with improvement over placebo in migraine-specific quality of life, overall health status, patients' global impression of change with treatment, and productivity in patients with CM.
CLINICALTRIALSGOV IDENTIFIER


NCT02621931.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that in patients with CM, treatment with fremanezumab quarterly or monthly is associated with improvements in health-related quality of life and productivity.",2020,"Fremanezumab quarterly and monthly was associated with significant improvements over placebo in change from baseline mean scores in MSQoL domains (all,  p  < 0.05) to week 12.","['patients with chronic migraine (CM', 'Patients With Chronic Migraine', '1121 patients: 375 patients with quarterly dosing, 375 with monthly dosing, and 371 with', 'patients with CM']","['fremanezumab', 'fremanezumab quarterly (675 mg at baseline, placebo', 'Fremanezumab', 'fremanezumab quarterly or monthly vs placebo', 'placebo']","[""health-related quality of life, health status, patients' global impression of change, and productivity"", 'Quality of Life and Productivity', 'health-related quality of life and productivity', 'migraine-specific quality of life, overall health status', 'EuroQoL 5-dimension, 5-response level (EQ-5D-5L) questionnaire and Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire', 'Migraine-Specific Quality of Life (MSQoL) questionnaire', 'PGIC scores', 'WPAI:GH scores', 'Patient Global Impression of Change (PGIC) questionnaire', 'EQ-5D-5L visual analog scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C4517854', 'cui_str': '675'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",1121.0,0.33054,"Fremanezumab quarterly and monthly was associated with significant improvements over placebo in change from baseline mean scores in MSQoL domains (all,  p  < 0.05) to week 12.","[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA. Richard.Lipton@einstein.yu.edu.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Sanjay K', 'Initials': 'SK', 'LastName': 'Gandhi', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Yeung', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Dawn C', 'Initials': 'DC', 'LastName': 'Buse', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}]",Neurology,['10.1212/WNL.0000000000010000']
1283,32747931,"Characterization of Clostridioides difficile isolates recovered from two Phase 3 surotomycin treatment trials by restriction endonuclease analysis, PCR ribotyping and antimicrobial susceptibilities.","OBJECTIVES


To investigate the molecular epidemiology and antimicrobial susceptibility of Clostridioides difficile isolates from patients with C. difficile infection (CDI) from two Phase 3 clinical trials of surotomycin.
METHODS


In both trials [Protocol MK-4261-005 (NCT01597505) conducted across Europe, North America and Israel; and Protocol MK-4261-006 (NCT01598311) conducted across North America, Asia-Pacific and South America], patients with CDI were randomized (1:1) to receive oral surotomycin (250 mg twice daily) or oral vancomycin (125 mg four times per day) for 10 days. Stool samples were collected at baseline and C. difficile isolates were characterized by restriction endonuclease analysis (REA) and PCR ribotyping. Susceptibility testing was performed by agar dilution, according to CLSI recommendations.
RESULTS


In total, 1147 patients were included in the microbiological modified ITT population. Of 992 recovered isolates, 922 (92.9%) were typed. There was a high association between REA groups and their corresponding predominant PCR ribotype (RT) for BI, DH, G and CF strains. REA group A showed more diverse PCR RTs. Overall, the most common strain was BI/RT027 (20.3%) followed by Y/RT014/020 (15.0%) and DH/RT106 (7.2%). The BI/RT027 strain was particularly prevalent in Europe (29.9%) and Canada (23.6%), with lower prevalence in the USA (16.8%) and Australia/New Zealand (3.4%). Resistance was most prevalent in the BI/RT027 strain, particularly to metronidazole, vancomycin and moxifloxacin.
CONCLUSIONS


A wide variation in C. difficile strains, both within and across different geographical regions, was documented by both REA and ribotyping, which showed overall good correlation.",2020,"There was a high association between REA groups and their corresponding predominant PCR ribotype (RT) for BI, DH, G and CF strains.","['patients with C. difficile infection (CDI', '1147 patients were included in the microbiological modified ITT population', 'Europe, North America and Israel; and Protocol MK-4261-006 (NCT01598311) conducted across North America, Asia-Pacific and South America], patients with CDI']","['oral surotomycin', 'oral vancomycin', 'metronidazole, vancomycin and moxifloxacin', 'REA']",['diverse PCR RTs'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0037713', 'cui_str': 'South America'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0360373', 'cui_str': 'Vancomycin-containing product in oral dose form'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0012906', 'cui_str': 'DNA Restriction Enzyme'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}]",1147.0,0.0890204,"There was a high association between REA groups and their corresponding predominant PCR ribotype (RT) for BI, DH, G and CF strains.","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Cheknis', 'Affiliation': 'Edward Hines, Jr. VA Hospital, Hines, IL, USA.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Devaris', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Chesnel', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Dale', 'Affiliation': 'ACM Global Laboratories, Rochester, NY, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Nary', 'Affiliation': 'ACM Global Laboratories, Rochester, NY, USA.'}, {'ForeName': 'Susan P', 'Initials': 'SP', 'LastName': 'Sambol', 'Affiliation': 'Edward Hines, Jr. VA Hospital, Hines, IL, USA.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': 'Citron', 'Affiliation': 'R.M. Alden Research Laboratory, Culver City, CA, USA.'}, {'ForeName': 'Richard V', 'Initials': 'RV', 'LastName': 'Goering', 'Affiliation': 'Creighton University, Omaha, NE, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Edward Hines, Jr. VA Hospital, Hines, IL, USA.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa297']
1284,32758684,Is it worth using low-cost glass ionomer cements for occlusal ART restorations in primary molars? 2-year survival and cost analysis of a Randomized clinical trial.,"OBJECTIVE


To evaluate the 2-year survival rate and the cost-effectiveness of Atraumatic Restorative Treatment (ART) using three different glass ionomer cements (GICs) for restoring occlusal dentin caries lesions in primary molars.
METHODS


One hundred and fifty (150) 4-8-year-old children were selected, randomly allocated and treated in school tables according to the restorative material: Fuji IX Gold Label (GC Corp), Vitro Molar (nova DFL) and Maxxion R (FGM), the latter two being low-cost brands. Materials and professionals' costs were considered to analyse baseline total cost, and from this the cumulative cost of each treatment was calculated. Restoration assessments were performed after 2, 6, 12 and 24 months by an independent calibrated examiner. Restoration survival was estimated using Kaplan-Meier survival analysis and Cox regression was used to test association with clinical factors. Bootstrap regression (1,000 replications) compared material´s cost over time and Monte-Carlo simulation was used to build cost-effectiveness scatter plots.
RESULTS


The overall survival rate of occlusal ART restorations after 2 years was 53% (Fuji IX = 72.7%; Vitro Molar = 46.5%; Maxxion R = 39.6%). Restorations performed with Vitro Molar and Maxxion R were more likely to fail when compared to Fuji IX. At baseline, Fuji IX was the more expensive option (p < 0.001), however, considering the simulation of accumulated cost caused by failures until 2-year evaluation, no difference was found between the groups.
CONCLUSIONS


After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).",2020,"After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).","['150 4-8-year-old children', 'primary molars']","['glass ionomer cements (GICs', 'restorative material: Fuji IX Gold Label (GC Corp), Vitro Molar (nova DFL) and Maxxion R (FGM', 'Atraumatic Restorative Treatment (ART', 'Fuji IX']","['overall survival rate of occlusal ART restorations', 'Restoration survival', '2-year survival rate']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}, {'cui': 'C0671561', 'cui_str': 'fuji IX'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C3529286', 'cui_str': 'Maxxion'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.0977731,"After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).","[{'ForeName': 'Isabel Cristina', 'Initials': 'IC', 'LastName': 'Olegário', 'Affiliation': 'Department of Public and Child Dental Health, Dublin Dental University Hospital, University of Dublin, Trinity College, Dublin, Ireland; Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Nathalia de Miranda', 'Initials': 'NM', 'LastName': 'Ladewig', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hesse', 'Affiliation': 'Department of Cariology, Endodontics and Pedodontology, Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, the Netherlands.'}, {'ForeName': 'Clarissa Calil', 'Initials': 'CC', 'LastName': 'Bonifácio', 'Affiliation': 'Department of Cariology, Endodontics and Pedodontology, Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, the Netherlands.'}, {'ForeName': 'Mariana Minatel', 'Initials': 'MM', 'LastName': 'Braga', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'José Carlos Pettorossi', 'Initials': 'JCP', 'LastName': 'Imparato', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fausto Medeiros', 'Initials': 'FM', 'LastName': 'Mendes', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela Prócida', 'Initials': 'DP', 'LastName': 'Raggio', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: danielar@usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103446']
1285,32763240,"A Phase 1b safety study of SER-287, a spore-based microbiome therapeutic, for active mild to moderate ulcerative colitis.","BACKGROUND & AIMS


Firmicutes bacteria produce metabolites that maintain the intestinal barrier and mucosal immunity. Firmicutes are reduced in the intestinal microbiota of patients with ulcerative colitis (UC). In a phase 1b trial of patients with UC, we evaluated the safety and efficacy of SER-287, an oral formulation of Firmicutes spores, and the effects of vancomycin preconditioning on expansion (engraftment) of SER-287 species in the colon.
METHODS


We conducted a double-blind trial of SER-287 in 58 adults with active mild-to-moderate UC (modified Mayo scores 4-10, endoscopic subscores ≥1). Participants received 6 days of preconditioning with oral vancomycin (125 mg, 4 times daily) or placebo followed by 8 weeks of oral SER-287 or placebo. Patients were randomly assigned (2:3:3:3) to groups that received placebo followed by either placebo or SER-287 once weekly, or vancomycin followed by SER-287 once weekly or SER-287 once daily. Clinical endpoints included safety and clinical remission (modified Mayo score ≤ 2; endoscopic subscores 0 or 1). Microbiome endpoints included SER-287 engraftment (dose species detected in stool after, but not before, SER-287 administration). Engraftment of SER-287 and changes in microbiome composition and associated metabolites were measured by analyses of stool specimens collected at baseline, after preconditioning, and during and 4 weeks after administration of SER-287 or placebo.
RESULTS


Proportions of patients with adverse events did not differ significantly among groups. A higher proportion of patients in the vancomycin/SER-287 daily group (40%) achieved clinical remission at week 8 than patients in the placebo/placebo group (0), placebo/SER-287 weekly group (13.3%), or vancomycin/SER-287 weekly group (17.7%) (P=.024 for vancomycin/SER-287 daily vs placebo/placebo). By day 7, higher numbers of SER-287 dose species were detected in stool samples from all SER-287 groups compared with the placebo group (P<.05), but this difference was not maintained beyond day 7 in the placebo/SER-287 weekly group. In the vancomycin groups, a greater number of dose species were detected in stool collected on day 10 and all subsequent time points, through 4 weeks post-dosing, compared with the placebo group (P<.05). A higher number of SER-287 dose species were detected in stool samples on days 7 and 10 from subjects who received daily vs weekly SER-287 doses (P<.05). Changes in fecal microbiome composition and metabolites were associated with both vancomycin/SER-287 groups.
CONCLUSIONS


In this small phase 1b trial of limited duration, the safety and tolerability of SER-287 were similar to placebo. SER-287 following vancomycin was significantly more effective than placebo for induction of remission in patients with active mild-to-moderate UC. Engraftment of dose species was facilitated by vancomycin preconditioning and daily dosing of SER-287.",2020,"By day 7, higher numbers of SER-287 dose species were detected in stool samples from all SER-287 groups compared with the placebo group (P<.05), but this difference was not maintained beyond day 7 in the placebo/SER-287 weekly group.","['patients with active mild-to-moderate UC', '58 adults with active mild-to-moderate UC (modified Mayo scores 4-10, endoscopic subscores ≥1', 'active mild to moderate ulcerative colitis', 'patients with ulcerative colitis (UC', 'patients with UC']","['placebo or SER-287', 'vancomycin', 'oral SER-287 or placebo', 'placebo/placebo', 'vancomycin/SER-287 daily vs placebo/placebo', 'preconditioning with oral vancomycin', 'vancomycin followed by SER-287 once weekly or SER-287 once daily', 'placebo/SER-287', 'vancomycin/SER-287', 'vancomycin preconditioning', 'vancomycin preconditioning and daily dosing of SER-287', 'SER-287', 'placebo']","['numbers of SER-287 dose species', 'safety and efficacy of SER-287', 'safety and clinical remission (modified Mayo score ≤ 2; endoscopic subscores 0 or 1', 'microbiome composition and associated metabolites', 'intestinal microbiota', 'SER-287 engraftment', 'number of dose species', 'safety and tolerability of SER-287', 'fecal microbiome composition and metabolites', 'adverse events', 'clinical remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036720', 'cui_str': 'Serine'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1709632', 'cui_str': 'Precondition'}, {'cui': 'C0360373', 'cui_str': 'Vancomycin-containing product in oral dose form'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036720', 'cui_str': 'Serine'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",58.0,0.414313,"By day 7, higher numbers of SER-287 dose species were detected in stool samples from all SER-287 groups compared with the placebo group (P<.05), but this difference was not maintained beyond day 7 in the placebo/SER-287 weekly group.","[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Henn', 'Affiliation': ''}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': ""O'Brien"", 'Affiliation': ''}, {'ForeName': 'Liyang', 'Initials': 'L', 'LastName': 'Diao', 'Affiliation': ''}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': ''}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Huttenhower', 'Affiliation': ''}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Wortman', 'Affiliation': ''}, {'ForeName': 'Barbara H', 'Initials': 'BH', 'LastName': 'McGovern', 'Affiliation': ''}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Wang-Weigand', 'Affiliation': ''}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Lichter', 'Affiliation': ''}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Chafee', 'Affiliation': ''}, {'ForeName': 'Chris B', 'Initials': 'CB', 'LastName': 'Ford', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bernardo', 'Affiliation': ''}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Simmons', 'Affiliation': ''}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Tomlinson', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cook', 'Affiliation': ''}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Pomerantz', 'Affiliation': ''}, {'ForeName': 'Bharat K', 'Initials': 'BK', 'LastName': 'Misra', 'Affiliation': ''}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Auninš', 'Affiliation': ''}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Trucksis', 'Affiliation': ''}]",Gastroenterology,['10.1053/j.gastro.2020.07.048']
1286,32769533,Does Virtual Reality Improve Procedural Completion and Accuracy in an Intramedullary Tibial Nail Procedure? A Randomized Control Trial.,"BACKGROUND


Artificial reality technologies are currently being explored as potential options to improve surgical education. Previous studies have primarily examined the efficacy of artificial reality in laparoscopic procedures, but to our knowledge, none have been performed in orthopaedically relevant procedures such as intramedullary tibial nailing, which calls for more versatile large-scale movements.
QUESTIONS/PURPOSES


Does a virtual reality simulator with or without a standard technique guide result in (1) a higher proportion of participants who completed the insertion of an intramedullary tibial nail in a synthetic bones model and (2) greater procedural accuracy than does training with a technique guide alone?
METHODS


Twenty-five first- and second-year medical students without prior exposure to intramedullary tibial nail insertion were recruited. Participants were randomly assigned to the technique guide control group (n = 8), the virtual reality group (n = 8), or the virtual reality and technique guide group (n = 9). The technique guide was adapted from a commercially available technique guide, which participants in the assigned groups could use to prepare as much as desired. The virtual reality simulation was based on the same procedure, and we used a commercially available virtual reality simulator that we purchased for this task. Participants in the virtual reality experimental groups completed the simulation on three separate sessions, at a set interval of 3 to 4 days apart. After 10 to 14 days of preparation, all participants attempted to insert an intramedullary nail into an intact, compact bone-model tibia that lacked surrounding soft tissue. Participants were given written hints if requested, but no other assistance was given. A procedure was considered complete if the nail and screw were properly placed. Procedural accuracy was defined as the number of incorrect steps normalized out of the 16 possible performed. After the procedure, one orthopaedic surgeon assessed a blinded video of the participant performing it so the assessor could not recognize the individual or that individual's gender. Additionally, the assessor was unaware of which group each participant had been randomized to during the evaluation.
RESULTS


A higher proportion of participants in the virtual reality group (6 of 8) and the virtual reality and technique guide group (7 of 9) completed the intramedullary nail than did participants in the technique guide group (2 of 8; p = 0.01). There was no difference in completion between the virtual reality groups (p = 0.89). Participants in the virtual reality and virtual reality and technique guide had fewer normalized incorrect steps than did participants in the technique guide group (3.2 ± 0.1 of 16 and 3.1 ± 0.1 of 16 versus 5.7 ± 0.2 of 16, respectively; p = 0.02 for comparisons of virtual reality groups to technique guide, p = 0.63 between the virtual reality group).
CONCLUSIONS


Virtual reality increased both procedural accuracy and the completion proportion compared with a technique guide in medical students. Based on our findings, virtual reality may help residents learn the procedural workflow and movements required to perform surgical procedures. Future studies should examine how and when exactly the technology can be applied to residencies and its impact on residents.
LEVEL OF EVIDENCE


Level I, therapeutic study.",2020,"Participants in the virtual reality and virtual reality and technique guide had fewer normalized incorrect steps than did participants in the technique guide group (3.2 ± 0.1 of 16 and 3.1 ± 0.1 of 16 versus 5.7 ± 0.2 of 16, respectively; p = 0.02 for comparisons of virtual reality groups to technique guide, p = 0.63 between the virtual reality group).
","['Twenty-five', 'first- and second-year medical students without prior exposure to intramedullary tibial nail insertion were recruited']","['virtual reality group (n = 8), or the virtual reality and technique guide group']","['intramedullary nail', 'Procedural accuracy', 'normalized incorrect steps']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1512957', 'cui_str': 'Intramedullary route'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]",,0.0343419,"Participants in the virtual reality and virtual reality and technique guide had fewer normalized incorrect steps than did participants in the technique guide group (3.2 ± 0.1 of 16 and 3.1 ± 0.1 of 16 versus 5.7 ± 0.2 of 16, respectively; p = 0.02 for comparisons of virtual reality groups to technique guide, p = 0.63 between the virtual reality group).
","[{'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Orland', 'Affiliation': 'M. D. Orland, M. J. Patetta, E. Kayupoy, M. H. Gonzalez, Department of Orthopaedic Surgery, University of Illinois, Chicago, IL, USA M. Wieser, Institute for Orthopaedic Surgery, Lima, OH, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Patetta', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wieser', 'Affiliation': ''}, {'ForeName': 'Erdan', 'Initials': 'E', 'LastName': 'Kayupov', 'Affiliation': ''}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Gonzalez', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001362']
1287,32768792,The emotion regulatory function of online social networking: Preliminary experimental evidence.,"Correlational research suggests that emotion regulation deficits, which are known risk factors for substance addictions, may also play a role in the development of problem behaviors such as excessive or maladaptive use of social networking sites (SNS). This study sought to experimentally assess the hypothesized emotion regulatory function of SNS use. 139 undergraduates (53.2% female) were randomized to view brief movie clips known to reliably induce positive (37.4%), negative (29.5%), or neutral mood (33.1%) and then to browse a SNS (46.8%) or control website (53.2%). Mood and subjective urge to access SNS and the Internet were assessed before and after viewing the movie clips and browsing the websites. Participants meeting criteria for ""moderate"" levels of disordered SNS use self-reported significantly greater deficits in emotion regulation (p = .02, η p 2  = 0.14). Increases in positive and negative affect following the mood induction were associated with a decrease in subjective urge to access SNS (r = -0.22, p = .02, r = -0.28, p = .002, respectively). Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09). We replicate previous findings of greater emotion regulation deficits in individuals endorsing problematic SNS use. Increased positive and negative affect resulted in decreased urge to access SNS, suggesting that social networking may primarily serve to counter low-arousal emotions like boredom. Data provide initial experimental evidence to support the hypothesized emotion regulatory function of SNS, with SNS exposure resulting in increased positive affect. Findings suggest that interventions targeting problematic SNS use should incorporate strategies for improved emotion regulation.",2020,"Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09).","['individuals endorsing problematic SNS use', '139 undergraduates (53.2% female']",[],"['subjective urge to access SNS', 'deficits in emotion regulation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.0379552,"Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09).","[{'ForeName': 'Rae D', 'Initials': 'RD', 'LastName': 'Drach', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, United States.'}, {'ForeName': 'Natalia C', 'Initials': 'NC', 'LastName': 'Orloff', 'Affiliation': ""Department of Psychology, University at Albany, State University of New York, United States; Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, United States.""}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Hormes', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, United States. Electronic address: jhormes@albany.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106559']
1288,32772244,"Isokinetic eccentric exercise substantially improves mobility, muscle strength and size, but not postural sway metrics in older adults, with limited regression observed following a detraining period.","INTRODUCTION


Eccentric exercise can reverse age-related decreases in muscle strength and mass; however, no data exist describing its effects on postural sway. As the ankle may be more important for postural sway than hip and knee joints, and with older adults prone to periods of inactivity, the effects of two 6-week seated isokinetic eccentric exercise programmes, and an 8-week detraining period, were examined in 27 older adults (67.1 ± 6.0 years).
METHODS


Neuromuscular parameters were measured before and after training and detraining periods with subjects assigned to ECC (twice-weekly eccentric-only hip and knee extensor contractions) or ECC PF  (identical training with additional eccentric-only plantarflexor contractions) training programmes.
RESULTS


Significant (P < 0.05) increases in mobility (decreased timed-up-and-go time [- 7.7 to - 12.0%]), eccentric strength (39.4-58.8%) and vastus lateralis thickness (9.8-9.9%) occurred after both training programmes, with low-to-moderate weekly rate of perceived exertion (3.3-4.5/10) reported. No significant change in any postural sway metric occurred after either training programme. After 8 weeks of detraining, mobility (- 8.2 to - 11.3%), eccentric strength (30.5-50.4%) and vastus lateralis thickness (6.1-7.1%) remained significantly greater than baseline in both groups.
CONCLUSION


Despite improvements in functional mobility, muscle strength and size, lower-limb eccentric training targeting hip, knee and ankle extensor muscle groups was not sufficient to influence static balance. Nonetheless, as the beneficial functional and structural adaptations were largely maintained through an 8-week detraining period, these findings have important implications for clinical exercise prescription as the exercise modality, low perceived training intensity, and adaptive profile are well suited to the needs of older adults.",2020,", lower-limb eccentric training targeting hip, knee and ankle extensor muscle groups was not sufficient to influence static balance.","['27 older adults (67.1\u2009±\u20096.0 years', 'older adults']","['Eccentric exercise', 'seated isokinetic eccentric exercise programmes', 'ECC (twice-weekly eccentric-only hip and knee extensor contractions) or ECC PF  (identical training with additional eccentric-only plantarflexor contractions) training programmes', 'Isokinetic eccentric exercise']","['postural sway metric', 'vastus lateralis thickness', 'mobility, muscle strength and size, but not postural sway metrics', 'functional mobility, muscle strength and size', 'mobility', 'eccentric strength']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C4077283', 'cui_str': '67Ga-ethylenecysteamine cysteine'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}]",27.0,0.0138365,", lower-limb eccentric training targeting hip, knee and ankle extensor muscle groups was not sufficient to influence static balance.","[{'ForeName': 'Anthony David', 'Initials': 'AD', 'LastName': 'Kay', 'Affiliation': 'Centre for Physical Activity and Life Sciences, Faculty of Art, Science and Technology, University of Northampton, Northamptonshire, UK. tony.kay@northampton.ac.uk.'}, {'ForeName': 'Anthony John', 'Initials': 'AJ', 'LastName': 'Blazevich', 'Affiliation': 'Centre for Exercise and Sports Science Research (CESSR), School of Exercise and Health Sciences, Edith Cowan University, Joondalup, Australia.'}, {'ForeName': 'Millie', 'Initials': 'M', 'LastName': 'Fraser', 'Affiliation': 'Centre for Physical Activity and Life Sciences, Faculty of Art, Science and Technology, University of Northampton, Northamptonshire, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Ashmore', 'Affiliation': 'Centre for Physical Activity and Life Sciences, Faculty of Art, Science and Technology, University of Northampton, Northamptonshire, UK.'}, {'ForeName': 'Mathew William', 'Initials': 'MW', 'LastName': 'Hill', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, School of Life Sciences, Coventry University, Warwickshire, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04466-7']
1289,32778416,"Letter to the Editor on ""A Randomized Control Trial Comparing a Medial Stabilized Total Prosthesis to a Cruciate Retaining and Posterior Stabilized Design: A Report of the Clinical and Functional Outcome Following Total Knee Replacement"".",,2020,,[],"['Medial Stabilized Total Prosthesis to a Cruciate Retaining and Posterior Stabilized Design', 'Total Knee Replacement']",[],[],"[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",[],,0.0283064,,"[{'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Kulshrestha', 'Affiliation': 'Department of Orthopaedics and Joint Replacement Surgery, Command Hospital Air Force, Bengaluru, India.'}, {'ForeName': 'Munish', 'Initials': 'M', 'LastName': 'Sood', 'Affiliation': 'Department of Orthopaedics, Command Hospital, Chandimandir, India.'}, {'ForeName': 'Santhosh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Orthopaedics and Joint Replacement Surgery, Command Hospital Air Force, Bengaluru, India.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.07.040']
1290,32778417,"Response to Letter to the Editor on ""A Randomized Controlled Trial Comparing a Medial Stabilized Total Knee Prosthesis to a Cruciate Retaining and Posterior Stabilized Design: A Report of the Clinical and Functional Outcomes Following Total Knee Replacement"".",,2020,,[],"['Medial Stabilized Total Knee Prosthesis to a Cruciate Retaining and Posterior Stabilized Design', 'Total Knee Replacement']",[],[],"[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0182477', 'cui_str': 'Total knee joint prosthesis'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",[],,0.0552925,,"[{'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Dowsey', 'Affiliation': ""Department of Surgery, The University of Melbourne, St Vincent's Hospital, Melbourne, Victoria, Australia; Department of Orthopaedics, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Tim D', 'Initials': 'TD', 'LastName': 'Spelman', 'Affiliation': ""Department of Surgery, The University of Melbourne, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Choong', 'Affiliation': ""Department of Surgery, The University of Melbourne, St Vincent's Hospital, Melbourne, Victoria, Australia; Department of Orthopaedics, St Vincent's Hospital, Melbourne, Victoria, Australia.""}]",The Journal of arthroplasty,['10.1016/j.arth.2020.07.042']
1291,32773365,Effects of Aerobic Training Versus Breathing Exercises on Asthma Control: A Randomized Trial.,"BACKGROUND


Aerobic training and breathing exercises are interventions that improve asthma control. However, the outcomes of these 2 interventions have not been compared.
OBJECTIVE


To compare the effects of aerobic training versus breathing exercises on clinical control (primary outcome), quality of life, exercise capacity, and airway inflammation in outpatients with moderate-to-severe asthma.
METHODS


Fifty-four asthmatics were randomized into either the aerobic training group (AG, n = 29) or the breathing exercise group (BG, n = 25). Both interventions lasted for 24 sessions (2/week, 40 minutes/session). Asthma clinical control (Asthma Control Questionnaire [ACQ]), quality of life (Asthma Quality of Life Questionnaire), asthma symptom-free days (ASFD), airway inflammation, exercise capacity, psychological distress (Hospital Anxiety and Depression Scale), daily-life physical activity (DLPA), and pulmonary function were evaluated before, immediately after, and 3 months after the intervention.
RESULTS


Both interventions presented similar results regarding the ACQ score, psychological distress, ASFD, DLPA, and airway inflammation (P > .05). However, participants in the AG were 2.6 times more likely to experience clinical improvement at the 3-month follow-up than participants in the BG (P = .02). A greater proportion of participants in the AG also presented a reduction in the number of days without rescue medication use compared with BG (34% vs 8%; P = .04).
CONCLUSIONS


Outpatients with moderate-to-severe asthma who participated in aerobic training or breathing exercise programs presented similar results in asthma control, quality of life, asthma symptoms, psychological distress, physical activity, and airway inflammation. However, a greater proportion of participants in the AG presented improvement in asthma control and reduced use of rescue medication.",2020,"Both interventions presented similar results regarding the ACQ score, psychological distress, ASFD, DLPA, and airway inflammation (P > .05).","['Asthma Control', 'Fifty-four asthmatics', 'outpatients with moderate-to-severe asthma', 'Outpatients with moderate-to-severe asthma who participated in']","['Aerobic Training versus Breathing Exercises', 'aerobic training group (AG, n\xa0= 29) or the breathing exercise', 'aerobic training or breathing exercise programs', 'aerobic training versus breathing exercises', 'Aerobic training and breathing exercises']","['asthma control, quality of life, asthma symptoms, psychological distress, physical activity, and airway inflammation', 'ACQ score, psychological distress, ASFD, DLPA, and airway inflammation', 'quality of life, exercise capacity, and airway inflammation', 'asthma control and reduced use of rescue medication', 'Asthma clinical control (Asthma Control Questionnaire [ACQ]), quality of life (Asthma Quality of Life Questionnaire), asthma symptom-free days (ASFD), airway inflammation, exercise capacity, psychological distress (Hospital Anxiety and Depression Scale), daily-life physical activity (DLPA), and pulmonary function']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0436342', 'cui_str': 'Free of symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",54.0,0.0434033,"Both interventions presented similar results regarding the ACQ score, psychological distress, ASFD, DLPA, and airway inflammation (P > .05).","[{'ForeName': 'Karen B', 'Initials': 'KB', 'LastName': 'Evaristo', 'Affiliation': 'Department of Physical Therapy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Felipe Augusto Rodrigues', 'Initials': 'FAR', 'LastName': 'Mendes', 'Affiliation': 'Department of Physical Therapy, School of Medicine, University of São Paulo, São Paulo, Brazil; Department of Physical Therapy, Universidade Ibirapuera, São Paulo, Brazil.'}, {'ForeName': 'Milene G', 'Initials': 'MG', 'LastName': 'Saccomani', 'Affiliation': 'Department of Physical Therapy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Cukier', 'Affiliation': 'Department of Pulmonary Division (InCor), School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Regina M', 'Initials': 'RM', 'LastName': 'Carvalho-Pinto', 'Affiliation': 'Department of Pulmonary Division (InCor), School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marcos R', 'Initials': 'MR', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Sports, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Danilo F', 'Initials': 'DF', 'LastName': 'Santaella', 'Affiliation': 'Department of Sports, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Beatriz M', 'Initials': 'BM', 'LastName': 'Saraiva-Romanholo', 'Affiliation': 'Department of Medicine, School of Medicine, University of São Paulo, São Paulo, Brazil; Department of Physical Therapy, University City of Sao Paulo (UNICID), São Paulo, Brazil.'}, {'ForeName': 'Milton A', 'Initials': 'MA', 'LastName': 'Martins', 'Affiliation': 'Department of Sports, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Celso R F', 'Initials': 'CRF', 'LastName': 'Carvalho', 'Affiliation': 'Department of Physical Therapy, School of Medicine, University of São Paulo, São Paulo, Brazil. Electronic address: cscarval@usp.br.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.06.042']
1292,32773366,A Model of Intervention and Implementation of Quality Building and Quality Control in Childcare Centers to Strengthen the Mental Health and Development of 1-3-Year Olds: Protocol for a Randomized Controlled Trial of Thrive by Three.,"BACKGROUND


Universal, high-quality childcare offers a unique opportunity to prevent developmental trajectories leading to mental health problems. Yet, growing evidence has shown that the process quality of Norwegian childcare centers varies considerably, and that research-based models for quality building are significantly lacking.
OBJECTIVE


To examine whether a model for quality building in childcare centers, Thrive by Three, increases the quality of child-caregiver interactions, and promotes child development, well-being, and mental health.
METHODS


The Thrive by Three study is a clustered randomized controlled trial involving 187 toddler groups in childcare centers across 7 municipalities within southern and central Norway. Each center is randomly allocated to the intervention or wait-list control group. Data are collected at 4 points: preintervention (T1), midway (T2), postintervention (T3), and 1-year postintervention (T4). Primary outcomes are changes in childcare quality measured by the Classroom Assessment Scoring System toddler version (CLASS), Student-Teacher Relationship Scale, Short Form (STRS-SF), and Life in Early Childhood Programs (LECP), as well as child development and mental health measured by The Brief Infant Toddler Social and Emotional Assessment (BITSEA, parent and teacher report), the Caregiver-Teacher Report Form (C-TRF), and Child Behavior Checklist (parent report) from the Achenbach System of Empirically Based Assessment (ASEBA) from 1.5 to 5 years, and child well-being measured by the Leiden Inventory for Child's Well-Being in Day Care (LICW-D). Secondary outcomes are child cortisol levels, assessed in a subsample of 372 children.
RESULTS


As of August 2020, a total of 1531 children and 769 staff from 187 toddler groups were recruited. Because of turnover, the recruitment of staff will be ongoing until August 2020. As of January 2020, the intervention group has been working with Thrive by Three for 1.5 years. Data at T1, T2, and T3 from both the intervention and control groups have been completed and T4 will be completed in August 2020.
CONCLUSIONS


This study makes an important contribution to the field of quality building in childcare centers. The results will provide greater insight into how high quality can be obtained and the effects of high-quality early childcare on child mental health. This in turn will be significant for policymakers and to the Norwegian society at large.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03879733; https://clinicaltrials.gov/ct2/show/NCT03879733 and Norwegian Research Council 260624/H10; https://prosjektbanken.forskningsradet.no/#/project/NFR/260624/Sprak=en.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17726.",2020,"Data at T1, T2 and T3 from both the intervention and control group has been completed and T4 will be completed in June 2020.
","['187 toddler groups in childcare centers across seven municipalities within southern and central Norway', 'childcare centers', 'As of November 2018, a total of 1531 children and 769 staff, from 187 toddler-groups were recruited']",['intervention or waitlist (control) group'],"[""changes in childcare quality measured by the Classroom Assessment Scoring System (CLASS) toddler version, Student-Teacher Relationship Scale short form (STRS-SF), and Life in Early Childhood Programs (LECP), as well as child development and mental health, measured by The Brief Infant Toddler Social and Emotional Assessment (BITSEA, parent and teacher report), the Caregiver-Teacher Report Form (C-TRF) and Child Behavior Checklist (CBCL, parent report) from the Achenbach ASEBA from 1.5-5 years, and child well-being measured by the Leiden Inventory for Child's Well-Being in Day Care (LICW-D"", 'Child cortisol levels']","[{'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",1531.0,0.0912925,"Data at T1, T2 and T3 from both the intervention and control group has been completed and T4 will be completed in June 2020.
","[{'ForeName': 'Ratib', 'Initials': 'R', 'LastName': 'Lekhal', 'Affiliation': 'Department of Communication and Culture, Norwegian Business School, Oslo, Norway.'}, {'ForeName': 'May Britt', 'Initials': 'MB', 'LastName': 'Drugli', 'Affiliation': 'The Regional Centre for Child and Youth Mental Health and Child Welfare - Central Norway Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Turid Suzanne', 'Initials': 'TS', 'LastName': 'Berg-Nielsen', 'Affiliation': 'Regional Centre for Child and Adolescent Mental Health Eastern and Southern Norway, Oslo, Norway.'}, {'ForeName': 'Elisabet Solheim', 'Initials': 'ES', 'LastName': 'Buøen', 'Affiliation': 'Regional Centre for Child and Adolescent Mental Health Eastern and Southern Norway, Oslo, Norway.'}]",JMIR research protocols,['10.2196/17726']
1293,32782181,Text-only and picture conversation aids both supported shared decision making for breast cancer surgery: Analysis from a cluster randomized trial.,"OBJECTIVES


To determine if two encounter conversation aids for early-stage breast cancer surgery increased observed and patient-reported shared decision making (SDM) compared with usual care and if observed and patient-reported SDM were associated.
METHODS


Surgeons in a cluster randomized trial at four cancer centers were randomized to use an Option Grid, Picture Option Grid, or usual care. We used bivariate statistics, linear regression, and multilevel models to evaluate the influence of trial arm, patient socioeconomic status and health literacy on observed SDM (via OPTION-5) and patient-reported SDM (via collaboRATE).
RESULTS


From 311 recordings, OPTION-5 scores were 73/100 for Option Grid (n = 40), 56.3/100 for Picture Option Grid (n = 144), and 41.0/100 for usual care (n = 127; p < 0.0001). Top collaboRATE scores were 81.6 % for Option Grid, 80.0 % for Picture Option Grid, and 56.4 % for usual care (p < 0.001). Top collaboRATE scores correlated with an 8.60 point (95 %CI 0.66, 13.7) higher OPTION-5 score (p = 0.008) with no correlation in the multilevel analysis. Patients of lower socioeconomic status had lower OPTION-5 scores before accounting for clustering.
CONCLUSIONS


Both conversation aids led to meaningfully higher observed and patient-reported SDM. Observed and patient-reported SDM were not strongly correlated.
PRACTICE IMPLICATIONS


Healthcare providers could implement these conversation aids in real-world settings.",2020,"Top collaboRATE scores correlated with an 8.60 point (95 %CI 0.66, 13.7) higher OPTION-5 score (p = 0.008) with no correlation in the multilevel analysis.","['Surgeons in a cluster randomized trial at four cancer centers', 'breast cancer surgery']","['Option Grid, Picture Option Grid, or usual care', 'Text-only and picture conversation aids both supported shared decision making']",[],"[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}]",[],,0.13711,"Top collaboRATE scores correlated with an 8.60 point (95 %CI 0.66, 13.7) higher OPTION-5 score (p = 0.008) with no correlation in the multilevel analysis.","[{'ForeName': 'Renata W', 'Initials': 'RW', 'LastName': 'Yen', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Durand', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA; Université Toulouse III Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Harris', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Ward', 'Affiliation': 'Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'A James', 'Initials': 'AJ', 'LastName': ""O'Malley"", 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Schubbe', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Catherine H', 'Initials': 'CH', 'LastName': 'Saunders', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA; Centers for Health and Aging, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Elwyn', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA. Electronic address: glynelwyn@gmail.com.'}]",Patient education and counseling,['10.1016/j.pec.2020.07.015']
1294,32739670,"The effects of a transitional care program on discharge readiness, transitional care quality, health services utilization and satisfaction among Chinese kidney transplant recipients: A randomized controlled trial.","BACKGROUND


Kidney transplantation is the major treatment for end-stage renal disease (ESRD). However, kidney transplant recipients (KTRs) face severe challenges during the transition period from hospital discharge to home, increasing the risk of early hospital readmission (EHR) and affecting patient safety. Nevertheless, knowledge of effective transitional care for KTRs is limited in China.
OBJECTIVE


To evaluate the effectiveness of an innovative transitional care program in improving discharge readiness, transitional care quality, health services utilization and patient satisfaction among KTRs in China.
DESIGN


A prospective randomized controlled trial.
SETTINGS AND PARTICIPANTS


Patients admitted to undergo kidney transplantation were recruited in a general tertiary hospital in Chengdu, China.
METHODS


A total of 220 eligible patients were recruited and randomly assigned to the intervention and control groups. Participants in the intervention group received a transitional care intervention developed by the research team, including a risk assessment for early readmission, health education from admission to predischarge, individualized discharge planning, and a telephone follow-up once per week for one month and WeChat follow-up postdischarge. The control group received routine care of comparable length and follow-up contact. A trained research assistant collected all patients' baseline data on admission (T0), evaluated the discharge readiness (by the Readiness for Hospital Discharge Scale) on the day of discharge (T1), collected data on transitional care quality (by the Care Transition Measure-15) and patients' satisfaction with transitional care services (by a self-developed patient satisfaction scale) on the 30th day postdischarge (T2), and collected data on hospital readmission, unscheduled outpatient department visits, and emergency room visits on the 30th and 90th days (by a self-developed health services utilization record table) (T3) postdischarge. Intervention effects were analyzed using independent samples t-tests, Wilcoxon-Mann-Whitney U tests, Chi-square tests or Fisher's exact test.
RESULTS


Compared with the control group, the intervention group showed significantly better discharge readiness (personal status, P<0.001; knowledge, P = 0.010; coping ability, P<0.001; expected support, P = 0.007; total score, P<0.001), better transitional care quality (importance of preferences, P<0.001; management preparation, P<0.001; critical understanding, P = 0.003; written and understandable care plan, P = 0.012; total score, P<0.001), lower readmission rate at T2 (P = 0.033) and at T3 (P = 0.013), lower emergency room visit rate at T3 (P = 0.014), and better satisfaction with transitional care services (P<0.001).
CONCLUSIONS


This study provides evidence that an innovative transitional care program is effective in promoting KTRs' discharge readiness, transitional care quality, reducing hospital readmission and emergency room visits, and improving their satisfaction with transitional care services.
TRIAL REGISTRATION


Clinical Trials ChiCTR1800014971.",2020,"Compared with the control group, the intervention group showed significantly better discharge readiness (personal status, P<0.001; knowledge, P = 0.010; coping ability, P<0.001; expected support, P = 0.007; total score, P<0.001), better transitional care quality (importance of preferences, P<0.001; management preparation, P<0.001; critical understanding, P = 0.003; written and understandable care plan, P = 0.012; total score, P<0.001), lower readmission rate at T2 (P = 0.033) and at T3 (P = 0.013), lower emergency room visit rate at T3 (P = 0.014), and better satisfaction with transitional care services (P<0.001).
","['A total of 220 eligible patients', 'KTRs in China', 'Chinese kidney transplant recipients', 'Patients admitted to undergo kidney transplantation were recruited in a general tertiary hospital in Chengdu, China']","['transitional care program', 'transitional care intervention developed by the research team, including a risk assessment for early readmission, health education from admission to predischarge, individualized discharge planning, and a telephone follow-up once per week for one month and WeChat follow-up postdischarge', 'routine care of comparable length and follow-up contact', 'innovative transitional care program']","['discharge readiness', ""discharge readiness (by the Readiness for Hospital Discharge Scale) on the day of discharge (T1), collected data on transitional care quality (by the Care Transition Measure-15) and patients' satisfaction with transitional care services (by a self-developed patient satisfaction scale) on the 30th day postdischarge (T2), and collected data on hospital readmission, unscheduled outpatient department visits, and emergency room visits on the 30th and 90th days (by a self-developed health services utilization record table) (T3) postdischarge"", 'lower emergency room visit rate', 'lower readmission rate', 'discharge readiness, transitional care quality, health services utilization and satisfaction', 'discharge readiness, transitional care quality, health services utilization and patient satisfaction', 'risk of early hospital readmission (EHR) and affecting patient safety', 'transitional care quality', ""samples t-tests, Wilcoxon-Mann-Whitney U tests, Chi-square tests or Fisher's exact test""]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0012622', 'cui_str': 'Discharge planning'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}, {'cui': 'C0008041', 'cui_str': 'Chi-Square Test'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}]",220.0,0.0555818,"Compared with the control group, the intervention group showed significantly better discharge readiness (personal status, P<0.001; knowledge, P = 0.010; coping ability, P<0.001; expected support, P = 0.007; total score, P<0.001), better transitional care quality (importance of preferences, P<0.001; management preparation, P<0.001; critical understanding, P = 0.003; written and understandable care plan, P = 0.012; total score, P<0.001), lower readmission rate at T2 (P = 0.033) and at T3 (P = 0.013), lower emergency room visit rate at T3 (P = 0.014), and better satisfaction with transitional care services (P<0.001).
","[{'ForeName': 'Rujun', 'Initials': 'R', 'LastName': 'Hu', 'Affiliation': 'West China School of Nursing/West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China; Emergency Department, Affiliated Hospital of Zunyi Medical University, Zunyi Medical University, Zunyi 563000, Guizhou, China; School of Nursing, Zunyi Medical University, Zunyi 563000, Guizhou, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Gu', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Qiling', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'KaiZhi', 'Initials': 'K', 'LastName': 'Xiao', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Xiaoyi', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Nephrology, Hemodialysis Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Turun', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Xiaolian', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'West China School of Nursing/West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China. Electronic address: jiangxiaolianhl@163.com.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103700']
1295,32739671,Effects and mediating mechanisms of a structured limbs-exercise program on general cognitive function in older adults with mild cognitive impairment: A randomized controlled trial.,"BACKGROUND


Exercise is known to prevent cognitive decline. Sleep quality and depression symptoms, which are associated with processing speed, are considered as common mediators in the exercise-cognition putative model. However, these mediating mechanisms have not been empirically tested in an intervention study.
OBJECTIVE


The aim of this study was to evaluate the effects of a structured limbs-exercise program on general cognitive function, and to test the mediating effects and mediating pathways of depressive symptoms, sleep quality and processing speed in the relationship of exercise-induced cognitive benefits.
DESIGN


A two-arm and assessor-blinded randomized controlled trial.
SETTINGS AND PARTICIPANTS


Community-dwelling older adults with mild cognitive impairment living in an urban area in Chifeng, China.
METHODS


Participants (N=116) were randomly allocated to one of the two arms: (1) a 24-week structured limbs-exercise program (3 supervised limb exercise sessions /week, 60 min /session for the first 12 weeks and 3 unsupervised practice sessions /week, 60 min /session for the following 12 weeks) or (2) health promotion classes alone. Measures of depressive symptoms, sleep quality, processing speed, and general cognitive function were collected at baseline, 12-week, and 24-week. Multivariate analysis of variance and structural equation modeling was used to test the effectiveness and mechanisms of structured limbs-exercise-induced cognitive improvement respectively.
RESULTS


The structured limbs-exercise program was beneficial for maintaining general cognitive function at 12 weeks (mean difference = 1.20, 95% CI [0.354, 2.054], p = 0.006) and at 24 weeks (mean difference = 1.59, 95% CI [0.722, 2.458], p = 0.001) in the intervention group. The results from the goodness-of-fit indices of structural equation modeling show as following: (1) The effect of structured limbs-exercise program on cognitive function was partially mediated by depressive symptoms, sleep quality, and processing speed, with 69.22% of joint mediation proportion; (2) Relative to the combined Z values of depressive symptoms and processing speed, sleep quality was more strongly related to cognitive function in the structured limbs-exercise program (Z= 9.294, p<0.01); (3) Processing speed was affected by depressive symptoms, sleep quality, and in turn, yielding a significant effect on cognitive function; and (4) Five potential mediating pathways for improvement in general cognitive function in the structured limbs-exercise intervention were identified.
CONCLUSION


This study shows that this exercise program can maintain general cognitive function for older adults with mild cognitive impairment. Mediating variables include depressive symptoms, sleep quality and processing speed. Future research should continue to incorporate path-oriented intervention strategies in the exercise intervention to maximize improvements in cognitive function. Registration number: ChiCTR1800016299.",2020,"The structured limbs-exercise program was beneficial for maintaining general cognitive function at 12 weeks (mean difference = 1.20, 95% CI [0.354, 2.054], p = 0.006) and at 24 weeks (mean difference = 1.59, 95% CI [0.722, 2.458], p = 0.001) in the intervention group.","['Community-dwelling older adults with mild cognitive impairment living in an urban area in Chifeng, China', 'Participants (N=116', 'older adults with mild cognitive impairment']","['exercise program', '24-week structured limbs-exercise program (3 supervised limb exercise sessions /week, 60\xa0min /session for the first 12 weeks and 3 unsupervised practice sessions /week, 60\xa0min /session for the following 12 weeks) or (2) health promotion classes alone', 'structured limbs-exercise program']","['general cognitive function', 'depressive symptoms, sleep quality, and processing speed', 'depressive symptoms, sleep quality', 'depressive symptoms and processing speed, sleep quality', 'cognitive function', 'depressive symptoms, sleep quality, processing speed, and general cognitive function', 'depressive symptoms, sleep quality and processing speed', 'Sleep quality and depression symptoms']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",116.0,0.141098,"The structured limbs-exercise program was beneficial for maintaining general cognitive function at 12 weeks (mean difference = 1.20, 95% CI [0.354, 2.054], p = 0.006) and at 24 weeks (mean difference = 1.59, 95% CI [0.722, 2.458], p = 0.001) in the intervention group.","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, Zhejiang 313000, China. Electronic address: aring2000@163.com.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, NY 10010, USA. Electronic address: bei.wu@nyu.edu.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Tao', 'Affiliation': 'AdventHealth Whole-Person Research, Orlando, FL 32804, USA. Electronic address: Hong.Tao@AdventHealth.com.'}, {'ForeName': 'Nannan', 'Initials': 'N', 'LastName': 'Chai', 'Affiliation': 'School of Nursing, Chifeng University, Chifeng, Inner Mongolia 024000, China. Electronic address: 151606873@qq.com.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, Zhejiang 313000, China. Electronic address: 17858368692@163.com.'}, {'ForeName': 'Xueting', 'Initials': 'X', 'LastName': 'Zhen', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, Zhejiang 313000, China. Electronic address: zhenxueting1029@163.com.'}, {'ForeName': 'Xianglian', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, Zhejiang 313000, China. Electronic address: 18777119676@163.com.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103706']
1296,32746950,Investigating cultural differences in the effects of expressive suppression when processing traumatic distressing material.,"BACKGROUND


While suppression is associated with detrimental post-traumatic psychological adjustment, research has not considered the effect of culture on this relationship.
AIMS


This study investigated cultural differences in the effects of expressive suppression, whilst watching a traumatic film, on subjective distress, psychophysiological responses and intrusive memory.
METHOD


Australians of European heritage or East Asian Australian participants (n = 82) were randomly assigned to either a suppression group (instructed to suppress their emotions during the film) or a control group (no instructions regarding emotion management). Electrodermal activity, heart rate and heart rate variability (root mean square of the successive differences; RMSSD) were measured pre-, during and post-film. Participants reported the number of film-related intrusions in the 5 min and 7 days post-viewing.
RESULTS


While the European Australian group did not differ significantly on RMSSD, the East Asian suppression group scored significantly higher on RMSSD during the film than the East Asian control group. Second, those in the suppression groups, regardless of cultural background, reported significantly fewer intrusions immediately post-film than controls. Third, we found that for the European Australian group, change in heart rate interacted with group (control versus suppression) when predicting weekly intrusions. However, for the East Asian group change in heart rate did not interact with group when predicting weekly intrusions.
CONCLUSIONS


The findings are discussed in the context of current research on culture and emotion regulation and implications for post-traumatic stress disorder.",2020,"While the European Australian group did not differ significantly on RMSSD, the East Asian suppression group scored significantly higher on RMSSD during the film than the East Asian control group.",['Australians of European heritage or East Asian Australian participants (n = 82'],['suppression group (instructed to suppress their emotions during the film) or a control group (no instructions regarding emotion management'],"['Electrodermal activity, heart rate and heart rate variability (root mean square of the successive differences; RMSSD', 'number of film-related intrusions', 'heart rate', 'RMSSD', 'subjective distress, psychophysiological responses and intrusive memory']","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0424129', 'cui_str': 'Suppressed emotion'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0561837', 'cui_str': 'Intrusive memories'}]",82.0,0.0302343,"While the European Australian group did not differ significantly on RMSSD, the East Asian suppression group scored significantly higher on RMSSD during the film than the East Asian control group.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Nagulendran', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Norton', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jobson', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465820000508']
1297,32746956,Health literacy and caregiver understanding in the CHD population.,"BACKGROUND


CHD is the most common birth defect type, with one-fourth of patients requiring intervention in the first year of life. Caregiver understanding of CHD may vary. Health literacy may be one factor contributing to this variability.
METHODS


The study occurred at a large, free-standing children's hospital. Recruitment occurred at a free-of-charge CHD camp and during outpatient cardiology follow-up visits. The study team revised the CHD Guided Questions Tool from an eighth- to a sixth-grade reading level. Caregivers of children with CHD completed the ""Newest Vital Sign"" health literacy screen and demographic surveys. Health literacy was categorised as ""high"" (Newest Vital Sign score 4-6) or ""low"" (score 0-3). Caregivers were randomised to read either the original or revised Guided Questions Tool and completed a validated survey measuring understandability and actionability of the Guided Questions Tool. Understandability and actionability data analysis used two-sample t-testing, and within demographic group differences in these parameters were assessed via one-way analysis of variance.
RESULTS


Eighty-two caregivers participated who were largely well educated with a high income. The majority (79.3%) of participants scored ""high"" for health literacy. No differences in understanding (p = 0.43) or actionability (p = 0.11) of the original and revised Guided Questions Tool were noted. There were no socio-economic-based differences in understandability or actionability (p > 0.05). There was a trend towards improved understanding of the revised tool (p = 0.06).
CONCLUSIONS


This study demonstrated that readability of the Guided Questions Tool could be improved. Future work is needed to expand the study population and further understand health literacy's impact on the CHD community.",2020,No differences in understanding (p = 0.43) or actionability (p = 0.11) of the original and revised Guided Questions Tool were noted.,"['Eighty-two caregivers participated who were largely well educated with a high income', 'Caregivers of children with CHD completed the ""Newest Vital Sign"" health literacy screen and demographic surveys']",[],"['Health literacy', 'understandability or actionability']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0524327', 'cui_str': 'Well educated'}, {'cui': 'C0948433', 'cui_str': 'High income'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0011296', 'cui_str': 'Demographic Survey'}]",[],"[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}]",82.0,0.0751818,No differences in understanding (p = 0.43) or actionability (p = 0.11) of the original and revised Guided Questions Tool were noted.,"[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Rodts', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Ndidi I', 'Initials': 'NI', 'LastName': 'Unaka', 'Affiliation': ""Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Statile', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College Of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Nicolas L', 'Initials': 'NL', 'LastName': 'Madsen', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College Of Medicine, Cincinnati, OH, USA.'}]",Cardiology in the young,['10.1017/S1047951120002243']
1298,32751064,"Effects of Mulligan Mobilization and Low-Level Laser Therapy on Physical Disability, Pain, and Range of Motion in Patients with Chronic Low Back Pain: A Pilot Randomized Controlled Trial.","This study aimed to determine the combined treatment effects of Mulligan sustained natural apophyseal glides (SNAGs) and low-level laser therapy (LLLT) on function, pain, and range of motion (ROM) in patients with chronic low back pain. A total of 49 adults participated in this study and were randomly divided into three groups (SNAGs with LLLT group, SNAGs group, and control group). The participants in the SNAGs with LLLT group received SNAGs for 10 min, LLLT for 10 min, and electrotherapy for 10 min. The SNAGs group received SNAGs for 10 min and electrotherapy for 20 min. The control group received electrotherapy for 30 min. All participants received the assigned treatment for 30 min a day, 3 times a week, for 4 weeks. We used the visual analogue scale (VAS) to measure pain, the modified-modified Schober test (MMST) to measure ROM, and the Roland Morris disability questionnaire (RMDQ) to measure physical disability. Compared to the pre-intervention values, the VAS and MMST scores significantly increased after the intervention in the SNAGs with LLLT group ( p  = 0.000) and the SNAGs group ( p  = 0.000). The RMDQ score significantly improved in the SNAGs with LLLT ( p  = 0.000), SNAGs ( p  = 0.000) and control ( p  = 0.025) group after the intervention. The inter-group differences were greater for the SNAGs with LLLT and SNAGs groups than for the control group ( p  = 0.001), and the difference was greater for the SNAGs with LLLT than for the SNAGs ( p  = 0.001) with respect to the VAS, MMST, and RMDQ scores. These results indicate that significant improvement in pain, function, and ROM may be achieved by a combination of SNAGs and LLLT to treat chronic low back pain.",2020,"The RMDQ score significantly improved in the SNAGs with LLLT ( p  = 0.000), SNAGs ( p  = 0.000) and control ( p  = 0.025) group after the intervention.","['Patients with Chronic Low Back Pain', '49 adults', 'patients with chronic low back pain']","['Mulligan sustained natural apophyseal glides (SNAGs) and low-level laser therapy (LLLT', 'Mulligan Mobilization and Low-Level Laser Therapy', 'electrotherapy', 'LLLT']","['VAS, MMST, and RMDQ scores', 'pain, function, and ROM', 'VAS and MMST scores', 'function, pain, and range of motion (ROM', 'RMDQ score', 'visual analogue scale (VAS) to measure pain, the modified-modified Schober test (MMST) to measure ROM, and the Roland Morris disability questionnaire (RMDQ) to measure physical disability', 'Physical Disability, Pain, and Range of Motion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0430750', 'cui_str': 'Modified Schober test'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}]",49.0,0.0393352,"The RMDQ score significantly improved in the SNAGs with LLLT ( p  = 0.000), SNAGs ( p  = 0.000) and control ( p  = 0.025) group after the intervention.","[{'ForeName': 'U-Hyeok', 'Initials': 'UH', 'LastName': 'Seo', 'Affiliation': 'Graduate School of Physical Therapy, Sahmyook University, Seoul 01795, Korea.'}, {'ForeName': 'Jung-Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Andong Science College, Andong 36616, Korea.'}, {'ForeName': 'Byoung-Hee', 'Initials': 'BH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Sahmyook University, Seoul 01795, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8030237']
1299,31611625,The relative importance of factors predicting outcome for myeloma patients at different ages: results from 3894 patients in the Myeloma XI trial.,"Disease factors such as tumor burden and molecular risk affect myeloma patient outcomes as well as patient factors that impact the capacity to deliver treatment. How the relative importance of these factors changes with patient age has not previously been investigated comprehensively. We analyzed data from 3894 patients of all ages uniformly treated in a large clinical trial of myeloma patients, Myeloma XI. Even with novel therapeutic approaches progression-free survival (PFS) and overall survival (OS) are affected by age with a stepwise reduction in PFS and OS with each decade increase. Renal function deteriorated with increasing age whilst the frequency of t(4;14) and del(17p) decreased and gain(1q) increased. The relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival varied by age group. Molecular events have a larger effect on outcome in younger patients with their relative contribution diminishing in the elderly. Performance status is important for patient outcome at all ages suggesting that physical frailty may be a more important predictor of outcome than age itself. Significant differences in the factors driving patient outcomes at different ages are important to consider as we design disease segmentation strategies to deliver personalized treatment approaches.",2020,"The relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival varied by age group.","['myeloma patients at different ages: results from 3894 patients in the Myeloma XI trial', 'younger patients with their relative contribution diminishing in the elderly', '3894 patients of all ages uniformly treated in a large clinical trial of myeloma patients, Myeloma XI']",[],"['relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival', 'progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0549177', 'cui_str': 'Large'}]",[],"[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0547204,"The relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival varied by age group.","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Pawlyn', 'Affiliation': 'The Institute of Cancer Research, London, UK. charlotte.pawlyn@icr.ac.uk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cairns', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kaiser', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Striha', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Vallari', 'Initials': 'V', 'LastName': 'Shah', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jenner', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Drayson', 'Affiliation': 'Clinical Immunology Service, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Owen', 'Affiliation': ""Haematological Malignancy Diagnostic Service (HMDS), St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Gregory', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': 'Section of Experimental Haematology, Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Morgan', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Jackson', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Davies', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, UK.'}]",Leukemia,['10.1038/s41375-019-0595-5']
1300,32755802,Distance to white matter trajectories is associated with treatment response to internal capsule deep brain stimulation in treatment-refractory depression.,"BACKGROUND


Deep brain stimulation (DBS) is an innovative treatment for treatment-refractory depression. DBS is usually targeted at specific anatomical landmarks, with patients responding to DBS in approximately 50% of cases. Attention has recently shifted to white matter tracts to explain DBS response, with initial open-label trials targeting white matter tracts yielding much higher response rates (>70%).
OBJECTIVE/HYPOTHESIS


Our aim was to associate distance to individual white matter tracts around the stimulation target in the ventral anterior limb of the internal capsule to treatment response.
METHODS


We performed diffusion magnetic resonance tractography of the superolateral branch of the medial forebrain bundle and the anterior thalamic radiation in fourteen patients that participated in our randomized clinical trial. We combined the tract reconstructions with the postoperative images to identify the DBS leads and estimated the distance between tracts and leads, which we subsequently associated with treatment response.
RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial. Biophysical modelling indicated that 37.5% of tracts were even outside the volume of activated tissue. There was no difference in lead placement with respect to anatomical landmarks, which could mean that differences in treatment response were driven by individual differences in white matter anatomy.
CONCLUSIONS


Our results suggest that deep brain stimulation of the ventral anterior limb of the internal capsule could benefit from targeting white matter bundles. We recommend acquiring diffusion magnetic resonance data for each individual patient.",2020,"RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial.",['fourteen patients that participated in our randomized clinical trial'],"['DBS', 'Deep brain stimulation (DBS', 'diffusion magnetic resonance tractography of the superolateral branch of the medial forebrain bundle and the anterior thalamic radiation']",['lead placement'],"[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0025055', 'cui_str': 'Structure of median forebrain bundle'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",,0.085274,"RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial.","[{'ForeName': 'Luka C', 'Initials': 'LC', 'LastName': 'Liebrand', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam UMC, University of Amsterdam, Department of Biomedical Engineering and Physics, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands. Electronic address: L.C.Liebrand@amsterdamumc.nl.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Natarajan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Matthan W A', 'Initials': 'MWA', 'LastName': 'Caan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Biomedical Engineering and Physics, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'P Richard', 'Initials': 'PR', 'LastName': 'Schuurman', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Neurosurgery, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Pepijn', 'Initials': 'P', 'LastName': 'van den Munckhof', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Neurosurgery, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'de Kwaasteniet', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Luigjes', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Isidoor O', 'Initials': 'IO', 'LastName': 'Bergfeld', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Damiaan', 'Initials': 'D', 'LastName': 'Denys', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands; Netherlands Institute for Neuroscience, Royal Academy of Arts and Sciences, Meibergdreef 47, Amsterdam, Netherlands.'}, {'ForeName': 'Guido A', 'Initials': 'GA', 'LastName': 'van Wingen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102363']
1301,32763623,Effect of exogenous progesterone administration on smoking topography.,"INTRODUCTION


Progesterone has been implicated as protective against drug taking behaviors, including combustible cigarettes. While prior research indicates higher endogenous progesterone levels are associated with a reduction in smoking intensity (as measured by smoking topography), it is unknown if exogenous delivery of progesterone may have the same effect.
METHODS


This double-blind, counterbalanced, cross-over randomized trial enrolled women between the ages of 18 and 40 who smoked at least five cigarettes per day and were currently using oral contraceptives. After overnight abstinence participants attended two topography lab sessions. One lab session was conducted during progesterone (200 mg twice per day) treatment and the other was during placebo treatment. Analyses included linear mixed effect models to examine the effect of exogenous progesterone administration and endogenous progesterone values on topography outcomes.
RESULTS


Participants (n = 43) were 23.8 (standard deviation [SD] ± 4.5) years old, smoked 10.5 (SD ± 3.7) cigarettes per day. Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL (95% confidence interval [CI]: -536, -65; p-value = 0.01) with additional trends indicating possible reductions in the number of puffs, average puff volume, and average flow. There were no significant effects of endogenous progesterone on smoking topography outcomes.
CONCLUSIONS


Progesterone administration has the potential to reduce smoking intensity after overnight abstinence in women of reproductive age. Additional research is needed to explore how this may relate to smoking cessation outcomes in women of reproductive age.",2020,"Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL","['Participants (n\xa0=\xa043) were 23.8 (standard deviation [SD]\xa0±\xa04.5) years old, smoked 10.5 (SD\xa0±\xa03.7) cigarettes per day', 'trial enrolled women between the ages of 18 and 40 who smoked at least five cigarettes per day and were currently using oral contraceptives', 'women of reproductive age']","['progesterone', 'exogenous progesterone', 'Progesterone', 'placebo']","['cumulative puff volume', 'number of puffs, average puff volume, and average flow', 'smoking intensity', 'smoking topography']","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",43.0,0.178407,"Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Allen', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, United States. Electronic address: aliciaallen@arizona.edu.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Petersen', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, United States.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Harrison', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, United States.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Nair', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, United States.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106570']
1302,32763625,Evaluation of impact-shock on gait after the implementation of two different training programs in older adults.,"BACKGROUND


Gait is negatively affected with increasing age. It is widely accepted that training produces physical-functional improvements in older adults, which can be assessed with numerous physical-functional tests. However, very few studies have been carried out using accelerometry to analyse the training effect on kinetic and kinematic variables in older adults, and there is no one that investigate the effects of two different training programs. Therefore, the aim of this study is to analyse the effects of an interval-walking program and a multicomponent program on the acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed in older adults.
METHODS


23 participants were divided into multicomponent training group [n = 12, 7 female, 71.58 (4.56) years] and interval-walking group [n = 11, 6 female, 69.64 (3.56) years]. We evaluated the participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead.
FINDINGS


After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group. The maximum acceleration values for the head and the stride frequency also increased in the interval-walking group. Lower limb strength improved in both groups.
INTERPRETATION


Given the benefits we found for each of these programs, we encourage their consideration when planning older adults training programs and suggest that multicomponent programs should be introduced prior to the start of walking-based programs.",2020,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","['participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead', 'group [n\xa0=\xa012, 7 female, 71.58 (4.56) years] and interval-walking group [n\xa0=\xa011, 6 female, 69.64 (3.56) years', 'older adults', '23 participants']","['multicomponent training', 'interval-walking program and a multicomponent program']","['Lower limb strength', 'maximum acceleration values', 'stride frequency', 'acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed']","[{'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517763', 'cui_str': '4.56'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",23.0,0.0172172,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sanchis-Sanchis', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Camacho-García', 'Affiliation': 'Departamento de Comunicaciones, Universitat Politècnica de València, Alcoy, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Encarnación-Martínez', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Pérez-Soriano', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain. Electronic address: pedro.perez-soriano@uv.es.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105131']
1303,32768592,Efficacy and safety of basiliximab as initial immunosuppression in liver transplantation: A single center study.,"INTRODUCTION AND AIM


The interleukin-2 receptor antagonist; basiliximab is used to allow delayed introduction of Calcineurin inhibitors (CNI) after liver transplantation and thus delay their renal insult. However, there is only little evidence for the safety and the efficacy of this regimen. This study aimed to evaluate the effectiveness and safety of basiliximab induction in liver transplantation.
MATERIALS AND METHODS


This study included 89 patients who were classified into two groups: standard triple immunosuppression (IS) regimen of steroid, tacrolimus (TAC) and mycophenolate mofetil (MMF) (n = 47) and induction IS regimen of basiliximab, low dose steroids and MMF with delayed introduction of CNI (n = 42). All patients were followed after liver transplantation for at least six months or until death.
RESULTS


There were no significant differences in patient survival, graft dysfunction, infection rate or type, or wound healing between both groups. The acute rejection rate was equivalent in both groups. Renal dysfunction in the first six months post-transplant was less in the basiliximab group in comparison to the other group (7.1% and 19.1% respectively).
CONCLUSION


Basiliximab-induced IS protocol is a safe regimen that reduces medium-term renal dysfunction and achieves similar survival without increasing the acute rejection or infection rate in liver transplantation recipients.",2020,"There were no significant differences in patient survival, graft dysfunction, infection rate or type, or wound healing between both groups.","['liver transplantation recipients', '89 patients who were classified into two groups', 'Liver Transplantation']","['interleukin-2 receptor antagonist', 'Basiliximab', 'standard triple immunosuppression (IS) regimen of steroid, tacrolimus (TAC) and mycophenolate mofetil (MMF) (n\u2009=\u200947) and induction IS regimen of basiliximab, low dose steroids and MMF with delayed introduction of CNI', 'Basiliximab-induced IS protocol']","['Efficacy and Safety', 'Renal dysfunction', 'acute rejection rate', 'patient survival, graft dysfunction, infection rate or type, or wound healing']","[{'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0034819', 'cui_str': 'Interleukin-2 receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0676831', 'cui_str': 'basiliximab'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1167870', 'cui_str': 'Transplant dysfunction'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",89.0,0.0258293,"There were no significant differences in patient survival, graft dysfunction, infection rate or type, or wound healing between both groups.","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hashim', 'Affiliation': 'Department of Hepatology, National Liver Institute, Menoufiya University, Shebin Elkom, Egypt. Electronic address: msaadhh@hotmail.com.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Alsebaey', 'Affiliation': 'Department of Hepatology, National Liver Institute, Menoufiya University, Shebin Elkom, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Ragab', 'Affiliation': 'Department of Hepatology, National Liver Institute, Menoufiya University, Shebin Elkom, Egypt.'}, {'ForeName': 'Hossam Eldeen', 'Initials': 'HE', 'LastName': 'Soliman', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, National Liver Institute, Menoufiya University, Shebin Elkom, Egypt.'}, {'ForeName': 'Imam', 'Initials': 'I', 'LastName': 'Waked', 'Affiliation': 'Department of Hepatology, National Liver Institute, Menoufiya University, Shebin Elkom, Egypt.'}]",Annals of hepatology,['10.5604/01.3001.0012.2246']
1304,32770667,Pharmacokinetics and Bioequivalence Estimation of Two Formulations of Alfuzosin Extended-Release Tablets.,"Alfuzosin is a medication approved by the US Food and Drug Administration to treat benign prostatic hyperplasia symptoms. Bioequivalence studies are demanded by regulatory authorities to evaluate the expected in vivo biological similarity of 2 formulations of a medication. The aim of this study is to assess the bioavailability of the generic (test) and branded (reference) formulations of 10-mg alfuzosin extended-release tablets after oral administration to healthy adults under fed conditions. The study used a comparative randomized, single-dose, 2-way crossover open-label study design. Thirty-three participants were recruited and completed the clinical assessment. The pharmacokinetic parameters maximum plasma concentration (C max  ), area under the plasma concentration-time curve (AUC 0-t  ), AUC extrapolated to infinity (AUC 0-∞  ), time to maximum concentration, and elimination half-life were estimated to prove bioequivalence. The confidence intervals for the log-transformed test/reference ratios for alfuzosin 110.7% (98.0-124.9) and 112.0% (101.9-123.1) for C max  and AUC 0-t  respectively, which are within the allowed limits specified by the regulatory authorities (80-125% for C max  and AUC 0-t  ). The test formulation can therefore be prescribed as an alternative to the reference for symptomatic treatment of benign prostatic hyperplasia.",2020,Bioequivalence studies are demanded by regulatory authorities to evaluate the expected in vivo biological similarity of 2 formulations of a medication.,"['Thirty-three participants were recruited and completed the clinical assessment', 'healthy adults under fed conditions']","['Alfuzosin Extended-Release Tablets', '10-mg alfuzosin', 'Alfuzosin', 'alfuzosin']","['pharmacokinetic parameters maximum plasma concentration (C max  ), area under the plasma concentration-time curve (AUC 0-t  ), AUC extrapolated to infinity (AUC 0-∞  ), time to maximum concentration, and elimination half-life']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0051150', 'cui_str': 'alfuzosin'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",33.0,0.0447721,Bioequivalence studies are demanded by regulatory authorities to evaluate the expected in vivo biological similarity of 2 formulations of a medication.,"[{'ForeName': 'Abdel Qader', 'Initials': 'AQ', 'LastName': 'Al Bawab', 'Affiliation': 'Faculty of Pharmacy, Al-Zaytoonah University of Jordan, Amman, Jordan.'}, {'ForeName': 'Bashar A', 'Initials': 'BA', 'LastName': 'Alkhalidi', 'Affiliation': 'School of Pharmacy, The University of Jordan, Amman, Jordan.'}, {'ForeName': ""Esra'a"", 'Initials': 'E', 'LastName': 'Albarahmieh', 'Affiliation': 'School of Applied Medical Sciences, German Jordanian University, Amman, Jordan.'}, {'ForeName': 'Sami M A', 'Initials': 'SMA', 'LastName': 'Qassim', 'Affiliation': 'Tabuk Pharmaceuticals, Tabuk, Kingdom of Saudi Arabia.'}, {'ForeName': 'Mohammad A D', 'Initials': 'MAD', 'LastName': 'Al-Saifi', 'Affiliation': 'Tabuk Pharmaceuticals, Tabuk, Kingdom of Saudi Arabia.'}, {'ForeName': 'Bashar', 'Initials': 'B', 'LastName': 'Al-Saifi', 'Affiliation': 'Tabuk Pharmaceuticals, Tabuk, Kingdom of Saudi Arabia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'University of Sunderland, Sunderland, UK.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Al-Qerem', 'Affiliation': 'Faculty of Pharmacy, Al-Zaytoonah University of Jordan, Amman, Jordan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.860']
1305,32770686,A Randomized Controlled Trial of Novel Loop Drainage Technique Versus Standard Incision and Drainage in the Treatment of Skin Abscesses.,"OBJECTIVES


The objective was to compare the failure rate of incision and drainage (I&D) with LOOP technique versus I&D with standard packing technique in adults and children presenting to the emergency department (ED) with subcutaneous abscess.
METHODS


This prospective, randomized controlled trial (NCT03398746) enrolled a convenience sample of patients presenting to two Level 1 trauma centers over 12 months with skin abscesses. Of 256 patients screened, 217 patients were enrolled, 109 randomized to I&D with packing (50%) and 108 (50%) to I&D with LOOP. The primary outcome was treatment failure defined by admission, IV antibiotics, or repeat drainage within 10-day follow-up. The secondary outcomes included ease of procedure, ease of care, pain, and satisfaction using a 10-point numeric rating scale.
RESULTS


There were no differences in patient characteristics between groups. Follow-up data were available in 196 (90%). Treatment failure occurred in 20% (range = 12%-28%) of packing patients and 13% (range = 6%-20%) of LOOP patients (p = 0.25). There were no significant differences in failure rates in adults (p = 0.82), but there was a significant difference in children (age ≤ 18 years) at 21% (range = 8%-34%) in the packing group and 0 (0%) in the LOOP group (p = 0.002). Operators reported no significant differences in ease of procedure between techniques (p = 0.221). There was significantly less pain at follow-up in the LOOP group versus packing (p = 0.004). The wound was much easier to care for over the first 36 hours in the LOOP group (p = 0.002). Patient satisfaction at 10 days postprocedure was significantly higher in the LOOP group (p = 0.005).
CONCLUSIONS


The LOOP and packing techniques had similar failure rates for treatment of subcutaneous abscesses in adults, but the LOOP technique had significantly fewer failures in children. Overall, pain and patient satisfaction were significantly better in patients treated using the LOOP technique.",2020,There was significantly less pain at follow-up in the LOOP group versus packing (p=0.004).,"['adults and children presenting to the ED with subcutaneous abscess', 'Skin Abscesses', '256 patients screened, 217 patients were enrolled, 109 randomized to I&D with packing (50%) and 108 (50%) to I&D with', 'patients presenting to two Level 1 trauma centers over 12-months with skin abscesses']","['LOOP', 'Novel Loop Drainage Technique versus Standard Incision and Drainage', 'incision and drainage (I&D) with LOOP technique versus I&D with standard packing technique']","['Patient satisfaction', 'Overall, pain and patient satisfaction', 'Treatment failure', 'treatment failure defined by admission, IV antibiotics, or repeat drainage within 10-day follow-up', 'ease of procedure, ease of care, pain and satisfaction using a 10-point numeric rating scale', 'pain', 'failure rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0149777', 'cui_str': 'Abscess of skin and/or subcutaneous tissue'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0152277', 'cui_str': 'Incision AND drainage'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0152277', 'cui_str': 'Incision AND drainage'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",217.0,0.152555,There was significantly less pain at follow-up in the LOOP group versus packing (p=0.004).,"[{'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Ladde', 'Affiliation': 'From the, Department of Emergency Medicine, Orlando Regional Medical Center, Orlando, FL, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': 'From the, Department of Emergency Medicine, Orlando Regional Medical Center, Orlando, FL, USA.'}, {'ForeName': 'Natali', 'Initials': 'N', 'LastName': 'Lilburn', 'Affiliation': 'the, Pasco County Emergency Physicians, Morton Plant North Bay Hospital, New Port Richey, FL, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Wan', 'Affiliation': 'and the, Department of Emergency Medicine, Dekalb Medical Center, Atlanta, GA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Papa', 'Affiliation': 'From the, Department of Emergency Medicine, Orlando Regional Medical Center, Orlando, FL, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14106']
1306,32771678,Gamma transcranial alternating current stimulation improves mood and cognition in patients with major depression.,"Major depression is one of the most common psychiatric disorders with a high rate of treatment resistance where new treatment options are urgently warranted. One of these new options are non-invasive brain stimulation techniques like transcranial magnetic or electric stimulation. One of the latter is transcranial Alternating Current Stimulation (tACS) in various frequencies. Here, we report a case series of six patients suffering from major depression treated with tACS in gamma (40 Hz) frequency. Patients were randomized to two groups, receiving either two 10-min stimulations (group 1) or a 20-min stimulation or per day (group 2) over ten days. Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2). Results also showed an improvement in cognitive functions assessed by word fluency and n-back test. It is hypothesized that gamma tACS could help to synchronize disturbed frequency bands in frontal and prefrontal cortex areas and thus restore dysbalanced neural connectivity in psychiatric disorders.",2020,"Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2).","['six patients suffering from major depression treated with tACS in gamma (40\xa0Hz) frequency', 'patients with major depression']","['Gamma transcranial alternating current stimulation', 'transcranial Alternating Current Stimulation (tACS', 'gamma tACS']","['Hamilton Depression Rating Scale and Beck Depression Inventory', 'cognitive functions assessed by word fluency and n-back test', 'mood and cognition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.0221377,"Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2).","[{'ForeName': 'Nikolas', 'Initials': 'N', 'LastName': 'Haller', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Senner', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany; Institute of Psychiatric Phenomics and Genomics (IPPG), Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Andre R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Department and Institute of Psychiatry, Laboratory of Neurosciences (LIM-27), University of Sao Paulo, Brazil.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Palm', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany; Medical Park Chiemseeblick, Bernau, Felden, Germany. Electronic address: u.palm@medicalpark.de.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.009']
1307,32776220,Multiple short bouts of exercise are better than a single continuous bout for cardiometabolic health: a randomised crossover trial.,"PURPOSE


To compare cardiometabolic responses to five consecutive days of daily postprandial exercise accumulated in three 10-min bouts or a single 30-min bout to a no-exercise control.
METHODS


Ten insufficiently active adults completed three trials in a randomised order. Each trial comprised five consecutive days of 30 min of exercise either accumulated in three separate 10-min bouts (ACC) after main meals; a single 30-min bout after dinner (CONT); or a no-exercise control (NOEX). Glucose regulation was assessed from an oral glucose tolerance test. Applanation tonometry was used to assess pulse wave velocity approximately 12 h following completion of the final trial.
RESULTS


Area under the 2-h glucose curve was similar for CONT (mean; 95% CI 917 mmol L -1  2 h -1 ; 815 to 1019) and ACC (931 mmol L -1  2 h -1 ; 794 to 1068, p = 0.671). Area under the 2-h insulin curve was greater following NOEX (70,328 pmol L -1  2 h -1 ; 30,962 to 109,693) than ACC (51,313 pmol L -1  2 h -1 : 21,822 to 80,806, p = 0.007). Pulse wave velocity was lower for ACC (5.96 m s -1 : 5.38 to 6.53) compared to CONT (6.93 m s -1 : 5.92 to 7.94, p = 0.031) but not significantly lower for ACC compared to NOEX (6.52 m s -1 : 5.70 to 7.34, p = 0.151).
CONCLUSION


Accumulating 30 min of moderate-intensity walking in three bouts throughout the day is more effective at reducing markers of cardiometabolic health risk in insufficiently active, apparently healthy adults than a single daily bout. Both accumulated and single-bout walking were equally as effective at reducing postprandial glucose concentrations compared to a no-exercise control. Therefore, accumulating exercise in short bouts after each main meal might be more advantageous for overall cardiometabolic health.",2020,Both accumulated and single-bout walking were equally as effective at reducing postprandial glucose concentrations compared to a no-exercise control.,['Ten insufficiently active adults'],"['CONT ', 'NOEX', 'NOEX ', 'Applanation tonometry', 'single 30-min bout after dinner (CONT); or a no-exercise control (NOEX', 'ACC', 'L']","['postprandial glucose concentrations', 'Glucose regulation', 'cardiometabolic responses', 'Pulse wave velocity', 'Area under the 2-h glucose curve', 'cardiometabolic health risk']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0430862', 'cui_str': 'Applanation tonometry'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C1879671', 'cui_str': 'After dinner'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",10.0,0.121961,Both accumulated and single-bout walking were equally as effective at reducing postprandial glucose concentrations compared to a no-exercise control.,"[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Shambrook', 'Affiliation': 'Holsworth Research Initiative, La Trobe Rural Health School, La Trobe University, P.O. Box 199, Bendigo, VIC, 3552, Australia.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Kingsley', 'Affiliation': 'Holsworth Research Initiative, La Trobe Rural Health School, La Trobe University, P.O. Box 199, Bendigo, VIC, 3552, Australia.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'Taylor', 'Affiliation': 'School of Allied Health, Human Services and Sport, La Trobe University, Bundoora, Australia.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Wundersitz', 'Affiliation': 'Holsworth Research Initiative, La Trobe Rural Health School, La Trobe University, P.O. Box 199, Bendigo, VIC, 3552, Australia.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Wundersitz', 'Affiliation': 'Angliss Hospital Community Rehabilitation Programme, Eastern Health, Melbourne, Australia.'}, {'ForeName': 'Brett A', 'Initials': 'BA', 'LastName': 'Gordon', 'Affiliation': 'Holsworth Research Initiative, La Trobe Rural Health School, La Trobe University, P.O. Box 199, Bendigo, VIC, 3552, Australia. b.gordon@latrobe.edu.au.'}]",European journal of applied physiology,['10.1007/s00421-020-04461-y']
1308,32777156,Improving the quality of preclinical simulation training for dental students using a new digital real-time evaluation system.,"BACKGROUND


With the rapid development of technology, traditional dental education has undergone a transition with the active incorporation of digital technology into curricula. DCARER is a recently developed digital real-time evaluation system for the digital assessment of student preclinical simulation practice performance. The system provides supplementary feedback on process analysis in addition to an objective final result. This study evaluated the grading validity of the DCARER system and its effect on dental preclinical practice skills training.
METHODS


Seventy-three residents of Grade 2018, all of whom had completed their 3-year term residencies in standardised and systematic training, were recruited into this study to examine the system's grading validity. All performed crown preparations with the adoption of the DCARER system, which generated both process and final scores. Three experts gave their own grade anonymously according to the final work. The differences between the digital system and the expert scores were analysed. In addition, 60 dental students in Grade 4 and 10 dental faculty members were randomly divided into traditional and digital groups. The students in the traditional group prepared the tooth with the guidance of supervisors, whilst the digital group used the DCARER system. After the class, the students' tooth preparations were scored by the same three experts in a blinded manner. The students and faculty members completed two different sets of questionnaires to evaluate the effects of teaching, acceptance, satisfaction, and evaluation accuracy of the digital system and the traditional method.
RESULTS


The grading validity assessment showed no significant difference between the tooth preparation scores given by the DCARER system and the experts (P> .05). The unique process scores given by the DCARER system were weakly correlated with the final scores given by both the digital system and the experts. The main characteristics of the 60 students and 10 faculty members were homogeneous at baseline (P> .05). The tooth preparations of the traditional group scored significantly lower than those of the digital group (P < .01). More students in the digital group (93.3%) believed the judgement to be objective than in the traditional group (73.3%). All students guided by the DCARER system (100%) and 80% of students taught in a traditional manner felt that the assessment reinforced the learning process. Faculty members reported that use of the digital system did not significantly increase their workload and reinforced the learning process for the internship.
CONCLUSION


The results presented here indicate the validity of grading using the digital real-time evaluation system. Students and faculty could benefit from application of the system in tooth preparation practice, which may provide effective clinical interaction training for dental education.",2020,The tooth preparations of the traditional group scored significantly lower than those of the digital group (P < 0.01).,"['60 dental students in Grade 4 and 10 dental faculty members', 'Seventy-three residents of Grade 2018, all of whom had completed their 3-year term residencies in standardized and systematic training', 'dental students']",[],[],"[{'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0015536', 'cui_str': 'Dental Faculties'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],[],,0.0241957,The tooth preparations of the traditional group scored significantly lower than those of the digital group (P < 0.01).,"[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology, Haidian District, PR China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology, Haidian District, PR China.'}, {'ForeName': 'Zhongning', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology, Haidian District, PR China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Qian', 'Affiliation': 'Department of General Dentistry, Peking University School and Hospital of Stomatology, #22, Zhongguancun South Avenue, Haidian District, Beijing, 100081, PR China.'}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology, Haidian District, PR China.'}, {'ForeName': 'Yunsong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology, Haidian District, PR China.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology, Haidian District, PR China.'}]",European journal of dental education : official journal of the Association for Dental Education in Europe,['10.1111/eje.12580']
1309,32783547,Vitamin D: does it help Tregs in active rheumatoid arthritis patients.,"Background Regulatory T cells (Tregs) play an important role in the maintenance of immunological tolerance. Tregs deficiency or suppressor functions reduction may be associated with autoimmune diseases development. Objectives To estimate the effect of vitamin D supplementation on Tregs level in the peripheral blood of active rheumatoid arthritis (RA) patients. Methods 40 active RA patients were randomly assigned into two groups. Group I received methotrexate (MTX) plus hydroxychloroquine, group II received MTX, hydroxychloroquine plus vitamin D supplementation for 3 months, and 30 healthy volunteers as control group. Peripheral blood Tregs were measured at baseline and after 3 months by Flow Cytometry. Results At baseline, Tregs percentage was significantly decreased (p<0.001) in both RA patient groups (13.52±1.95%, 13.65±2.98% respectively), compared to controls (28.44±7.37%) with no significant difference between the two patient groups (p=0.866). After 3 months, there was a significant elevation in Tregs percentage in group II compared to group I (p<0.001). Tregs elevation was associated with significant DAS-28 score reduction (p<0.001). Conclusion Vitamin D appears to have important immunomodulatory functions. Vitamin D supplementation can be combined safely with traditional DMARDs to regulate the immune system. Clinical trial registration Tanta University Protocol Record 33846, Vitamin D Effect in Rheumatoid Arthritis, http://www.clinicaltrials.gov, NCT04472481.",2020,"At baseline, the percentage of Tregs was significantly decreased (p<0.001) in both groups of RA patients (13.52 ±1.95 % and 13.65 ±2.98 % respectively), in comparison to controls (28.44 ±7.37%) with no significant difference between the two patient groups (p=0.866).","['active rheumatoid arthritis patients', '40 patients with active RA', 'active rheumatoid arthritis (RA) patients', 'Rheumatoid Arthritis', '30 healthy volunteers as a control group']","['Vitamin D', 'vitamin D supplementation', 'methotrexate (MTX) plus hydroxychloroquine', 'MTX and hydroxychloroquine plus vitamin D supplementation']","['percentage of Tregs', 'Peripheral blood Tregs', 'DAS-28 score reduction']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",30.0,0.223212,"At baseline, the percentage of Tregs was significantly decreased (p<0.001) in both groups of RA patients (13.52 ±1.95 % and 13.65 ±2.98 % respectively), in comparison to controls (28.44 ±7.37%) with no significant difference between the two patient groups (p=0.866).","[{'ForeName': 'Hanaa Samy', 'Initials': 'HS', 'LastName': 'El-Banna', 'Affiliation': 'Faculty of Medicine, Tanta University , Tanta, Egypt.'}, {'ForeName': 'Souzan Ezzat', 'Initials': 'SE', 'LastName': 'Gado', 'Affiliation': 'Faculty of Medicine, Tanta University , Tanta, Egypt.'}]",Expert review of clinical immunology,['10.1080/1744666X.2020.1805317']
1310,32783585,Small and large cutaneous fibers display different excitability properties to slowly increasing ramp pulses.,"The excitability of large nerve fibers is reduced when their membrane potential is slowly depolarizing, i.e., the fibers display accommodation. The aim of this study was to assess accommodation in small (mainly Aδ) and large (Aβ) cutaneous sensory nerve fibers using the perception threshold tracking (PTT) technique. Linearly increasing ramp currents (1 ms-200 ms) were used to assess the excitability of the nerve fibers by cutaneous electrical stimulation. To investigate the PPT technique's ability to preferentially activate different fiber types, topical application of lidocaine/prilocaine (EMLA) or a placebo cream was applied. By means of computational modeling, the underlying mechanisms governing the perception threshold in the two fiber types was studied. The axon models included the voltage-gated ion channels: transient TTX-sensitive sodium current, transient TTX-resistant sodium current (Na TTXr ), persistent sodium current, delayed rectifier potassium channel (K Dr ), slow potassium channel, and hyperpolarization-activated current. Large fibers displayed accommodation, whereas small fibers did not display accommodation ( P  < 0.05). For the pin electrode, a significant interaction was observed between cream (EMLA or placebo) and pulse duration ( P  < 0.05); for the patch electrode, there was no significant interaction between cream and duration, which supports the pin electrode's preferential activation of small fibers. The results from the computational model suggested that differences in accommodation between the two fiber types may originate from selective expression of voltage-gated ion channels, particularly the transient Na TTXr  and/or K Dr . The PTT technique could assess the excitability changes during accommodation in different nerve fibers. Therefore, the PTT technique may be a useful tool for studying excitability in nerve fibers in both healthy and pathological conditions. NEW & NOTEWORTHY  When large nerve fibers are stimulated by long, slowly increasing electrical pulses, interactive mechanisms counteract the stimulation, which is called accommodation. The perception threshold tracking technique was able to assess accommodation in both small and large fibers. The novelty of this study is that large fibers displayed accommodation, whereas small fibers did not. Additionally, the difference in accommodation between the fiber could be linked to expression of voltage-gated ion channels by means of computational modeling.",2020,"Large fibers displayed accommodation, whereas small fibers did not display accommodation (p<0.05).",[],"['placebo cream', 'lidocaine/prilocaine (EMLA', 'cream (EMLA or placebo', 'perception threshold tracking (PTT) technique']",['excitability changes'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0617623', 'cui_str': 'Lidocaine- and prilocaine-containing product'}, {'cui': 'C0059079', 'cui_str': 'Eutectic Mixture of Local Anesthetics'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0246953,"Large fibers displayed accommodation, whereas small fibers did not display accommodation (p<0.05).","[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Tigerholm', 'Affiliation': 'Integrative Neuroscience Group, Center for Neuroplasticity and Pain (CNAP), Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Tatiana Nielson', 'Initials': 'TN', 'LastName': 'Hoberg', 'Affiliation': 'Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Dorthe', 'Initials': 'D', 'LastName': 'Brønnum', 'Affiliation': 'Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Vittinghus', 'Affiliation': 'Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Ken Steffen', 'Initials': 'KS', 'LastName': 'Frahm', 'Affiliation': 'Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Carsten Dahl', 'Initials': 'CD', 'LastName': 'Mørch', 'Affiliation': 'Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}]",Journal of neurophysiology,['10.1152/jn.00629.2019']
1311,32787352,Evaluation of the effects of applying the ventricular care bundle (VCB) method for reducing ventilator-associated pneumonia (VAP) in the intensive care unit of a general Chinese tertiary hospital.,"BACKGROUND


Ventilator-associated pneumonia (VAP) is a severe complication that occurs within patients who must use ventilators in the intensive care unit (ICU). Ventilator care bundles (VCB) have been applied across many developed regions and have produced positive results in controlling VAP. In this study, we report on the implementation and effects of using VCBs to manage VAP in a general tertiary hospital in the Inner Mongolia Autonomous Region of China.
METHODS


A targeted surveillance method was used to survey all the patients (n=4,716) in the ICU from June 1, 2017 to May 31, 2019. Patients from June 1, 2017 to May 31, 2018, and June 1, 2018, to May 31, 2019, were respectively divided into 2 groups: the control group (2,029 patients) and intervention group (2,687 patients). These dates were selected because VCB was implemented from June 1, 2018, in our institution. The variables that were associated with VCB and observed were the head-of-bed elevation, oral care, maintenance of the pressure for the cuff of the endotracheal tube, aspiration of subglottic secretion, daily sedation vacation protocol, daily extubation assessment results, and hand hygiene. After collecting the data, the compliance of VCB, ventilator use ratio, and the incidence rate of VAP in these 2 groups were compared.
RESULTS


We observed that compliance with all of the intervention measures for VCB improved results in the intervention group compared to the control. Furthermore, the compliance rate of hand hygiene increased from 71.99% to 91.97%, and the head-of-bed elevation of 30°-45° increased from 62.02% to 85.96%. All differences between these two groups were statistically significant, according to the χ 2 -test. The ventilator use ratio was statistically and significantly lower in the intervention group (34.86%) compared to the control group (40.29%) (χ 2 =95.513, P<0.001). The incidence rate of VAP was statistically and significantly lower in the intervention group (13.70‰) compared to the control group (18.85‰) (χ 2 =5.471, P=0.019).
CONCLUSIONS


Our results show that VCB prevents VAP. Therefore, personnel training, clinical supervision, and surveillance feedback could promote a reduction in intervention measures.",2020,The ventilator use ratio was statistically and significantly lower in the intervention group (34.86%) compared to the control group (40.29%),"['ventilator-associated pneumonia (VAP) in the intensive care unit of a general Chinese tertiary hospital', 'Patients from June 1, 2017 to May 31, 2018, and June 1, 2018, to May 31, 2019, were respectively divided into 2 groups: the control group (2,029 patients) and intervention group (2,687 patients', 'patients (n=4,716) in the ICU from June 1, 2017 to May 31, 2019', 'general tertiary hospital in the Inner Mongolia Autonomous Region of China', 'patients who must use ventilators in the intensive care unit (ICU']","['VCBs', 'VCB', 'ventricular care bundle (VCB) method', 'Ventilator care bundles (VCB']","['compliance rate of hand hygiene', 'head-of-bed elevation, oral care, maintenance of the pressure for the cuff of the endotracheal tube, aspiration of subglottic secretion, daily sedation vacation protocol, daily extubation assessment results, and hand hygiene', 'incidence rate of VAP', 'ventilator use ratio', 'compliance of VCB, ventilator use ratio, and the incidence rate of VAP']","[{'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021515', 'cui_str': 'Inner Mongolia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0184634', 'cui_str': 'Ventilator care'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C3658308', 'cui_str': 'Care Bundles'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0184634', 'cui_str': 'Ventilator care'}]",,0.0316688,The ventilator use ratio was statistically and significantly lower in the intervention group (34.86%) compared to the control group (40.29%),"[{'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Yongfang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Yueying', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Yunting', 'Initials': 'Y', 'LastName': 'Hai', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Haoxue', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Xing', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Bai', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Bao', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ren', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Huijun', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Junwei', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Tianhui', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China. tianhui0409@126.com.""}]",Annals of palliative medicine,['10.21037/apm-20-289']
1312,32787361,Effects of the prolong life with nine turn method (Yan Nian Jiu Zhuan) Qigong on patients with chronic fatigue syndrome: study protocol for a randomized controlled trial.,"BACKGROUND


Chronic fatigue syndrome (CFS) is characterized by persistent fatigue, which often leads to physical and psychological damage. Cognitive behavioral therapy (CBT) is considered to be one of the most effective treatments. Prolong life with nine turn method (PLWNT) Qigong is a combination of complex two-way traffic path connecting the cognitive center and the enteric nerves. In this study protocol, we will explore the effectiveness of PLWNT for physical and mental fatigue, gastrointestinal function, depression, and sleep quality in patients with CFS using clinical effectiveness scales and functional magnetic imaging (fMRI).
METHODS


A randomized controlled trial (RCT) consisting of 90 patients will be divided into a CBT and PLWNT group. Both of the groups will include a supervised intervention at the Shanghai University of Traditional Chinese Medicine once a week, and the remaining six days will be completed at home over 12 consecutive weeks. The primary outcome variable will be the Multidimensional Fatigue Inventory (MFI20). Secondary outcomes will evaluate the Short Form 36-item Health Survey (SF-36), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and brain activation will be explored using fMRI.
RESULTS


This will be the first randomized controlled clinical trial to introduce the PLWNT method for the treatment of CFS. If these results demonstrate that CBT or PLWNT interventions are effective, they will provide a quality treatment plan for patients with chronic fatigue and optimize their guidance.
TRIAL REGISTRATION


Clinical Trials Registry, NCT03496961, Registered on April 12, 2018.",2020,"Secondary outcomes will evaluate the Short Form 36-item Health Survey (SF-36), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and brain activation will be explored using fMRI.
","['patients with CFS', 'patients with chronic fatigue syndrome', '90 patients', 'patients with chronic fatigue and optimize their guidance', 'Chronic fatigue syndrome (CFS']","['Qigong', 'CBT or PLWNT interventions', 'CBT and PLWNT', 'nine turn method (Yan Nian Jiu Zhuan', 'functional magnetic imaging (fMRI', 'Cognitive behavioral therapy (CBT', 'nine turn method (PLWNT']","['physical and mental fatigue, gastrointestinal function, depression, and sleep quality', 'Multidimensional Fatigue Inventory (MFI20', 'Short Form 36-item Health Survey (SF-36), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and brain activation will be explored using fMRI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0518656', 'cui_str': 'Chronic fatigue'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0044523', 'cui_str': '1-nitrosoindole-3-acetonitrile'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]",90.0,0.127951,"Secondary outcomes will evaluate the Short Form 36-item Health Survey (SF-36), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and brain activation will be explored using fMRI.
","[{'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Ziji', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yao', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China. doctoryaofei@126.com.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'Department of Traditional Chinese Medicine, Changhai Hospital, Naval Medical University, Shanghai, China. youyanli2005@163.com.'}]",Annals of palliative medicine,['10.21037/apm-19-461']
1313,32794334,Prognostic value of MRI-determined cervical lymph node size in nasopharyngeal carcinoma.,"OBJECTIVES


To investigate the prognostic value of magnetic resonance imaging (MRI)-determined cervical lymph node (CLN) size in nasopharyngeal carcinoma (NPC).
METHODS


We retrospectively reviewed 2066 patients with NPC treated with intensity-modulated radiotherapy, and randomly divided them into two groups, in a 1:1 ratio. One group was used for training (the training group), and the other one was for internal validation (the validation group). All patients had undergone MRI examination and the maximal axial diameters (MAD) of the axial plane of all positive nodes had been measured and recorded.
RESULTS


Of 683 patients with CLN metastases in the training group (n = 1033), MAD = 4 cm was associated with worse OS (64.7% vs 84.6%, P < .001), DFS (55.9% vs 76.3%, P = .001), and DMFS (67.6% vs 86.1%, P = .001). Multivariate analysis showed that MAD = 4 cm was a significant negative prognostic factor for OS (HR = 2.058; P = .025), DFS (HR = 1.727; P = .049), and DMFS (HR = 2.034; P = .036). When MRI-determined MAD = 4 cm was classified as N3 in the N classification, the OS, DFS, DMFS, and RRFS survival curves were well separated. The OS, DFS, DMFS, and RRFS concordance indexes were not statistically different between the proposed N staging system and the UICC/AJCC staging system in the training group, or between the training group and the validation group (all P = .05).
CONCLUSION


MAD = 4 cm on axial MRI slices can be recommended as a prognostic factor in future versions of the UICC/AJCC NPC staging system.",2020,"The OS, DFS, DMFS, and RRFS concordance indexes were not statistically different between the proposed N staging system and the UICC/AJCC staging system in the training group, or between the training group and the validation group (all P = .05).
","['683 patients with CLN metastases in the training group (n\xa0=\xa01033', '2066 patients with NPC treated with intensity-modulated', 'nasopharyngeal carcinoma', 'nasopharyngeal carcinoma (NPC']","['radiotherapy', 'magnetic resonance imaging (MRI)-determined cervical lymph node (CLN']","['DFS', 'undergone MRI examination and the maximal axial diameters (MAD', 'DMFS', 'OS, DFS, DMFS, and RRFS concordance indexes', 'worse OS', 'OS, DFS, DMFS, and RRFS survival curves']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588054', 'cui_str': 'Cervical lymph node group'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0588054', 'cui_str': 'Cervical lymph node group'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0254792', 'cui_str': 'ribosome releasing factor'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",2066.0,0.0325976,"The OS, DFS, DMFS, and RRFS concordance indexes were not statistically different between the proposed N staging system and the UICC/AJCC staging system in the training group, or between the training group and the validation group (all P = .05).
","[{'ForeName': 'Cheng-Long', 'Initials': 'CL', 'LastName': 'Huang', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yan-Ping', 'Initials': 'YP', 'LastName': 'Mao', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Imaging Diagnosis and Interventional Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Li-Zhi', 'Initials': 'LZ', 'LastName': 'Liu', 'Affiliation': 'Imaging Diagnosis and Interventional Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ai-Hua', 'Initials': 'AH', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ling-Long', 'Initials': 'LL', 'LastName': 'Tang', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}]",Cancer medicine,['10.1002/cam4.3392']
1314,32791499,Use of a Supportive Kidney Care Video Decision Aid in Older Patients: A Randomized Controlled Trial.,"BACKGROUND


There are few studies of patient-facing decision aids that include supportive kidney care as an option. We tested the efficacy of a video decision aid on knowledge of supportive kidney care among older patients with advanced CKD.
METHODS


Participants (age ≥ 65 years with advanced CKD) were randomized to receive verbal or video education. Primary outcome was knowledge of supportive kidney care (score range 0-3). Secondary outcomes included preference for supportive kidney care, and satisfaction and acceptability of the video.
RESULTS


Among all participants (n = 100), knowledge of supportive kidney care increased significantly after receiving education (p < 0.01); however, there was no difference between study arms (p = 0.68). There was no difference in preference for supportive kidney care between study arms (p = 0.49). In adjusted analyses, total health literacy score (aOR 1.08 [95% CI: 1.003-1.165]) and nephrologists' answer of ""No"" to the Surprise Question (aOR 4.87 [95% CI: 1.22-19.43]) were associated with preference for supportive kidney care. Most felt comfortable watching the video (96%), felt the content was helpful (96%), and would recommend the video to others (96%).
CONCLUSIONS


Among older patients with advanced CKD, we did not detect a significant difference between an educational verbal script and a video decision aid in improving knowledge of supportive kidney care or preferences. However, patients who received video education reported high satisfaction and acceptability ratings. Future research will determine the effectiveness of a supportive kidney care video decision aid on real-world patient outcomes.
TRIAL REGISTRATION


NCT02698722 (ClinicalTrials.gov).",2020,"In adjusted analyses, total health literacy score (aOR 1.08 [95% CI: 1.003-1.165]) and nephrologists' answer of ""No"" to the Surprise Question (aOR 4.87 [95% CI: 1.22-19.43]) were associated with preference for supportive kidney care.","['Participants (age ≥ 65 years with advanced CKD', 'Older Patients', 'older patients with advanced CKD']","['verbal or video education', 'video decision aid', 'Supportive Kidney Care Video Decision Aid']","['knowledge of supportive kidney care', 'satisfaction and acceptability ratings', 'total health literacy score', 'preference for supportive kidney care', 'educational verbal script', 'knowledge of supportive kidney care (score range 0-3', 'preference for supportive kidney care, and satisfaction and acceptability of the video']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0042655', 'cui_str': 'Video'}]",100.0,0.12439,"In adjusted analyses, total health literacy score (aOR 1.08 [95% CI: 1.003-1.165]) and nephrologists' answer of ""No"" to the Surprise Question (aOR 4.87 [95% CI: 1.22-19.43]) were associated with preference for supportive kidney care.","[{'ForeName': 'Nwamaka D', 'Initials': 'ND', 'LastName': 'Eneanya', 'Affiliation': 'Renal-Electrolyte Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA, nwamaka.eneanya@pennmedicine.upenn.edu.'}, {'ForeName': 'Shananssa G', 'Initials': 'SG', 'LastName': 'Percy', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Massachusetts General Hospital, Harvard Medical School Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Taylor L', 'Initials': 'TL', 'LastName': 'Stallings', 'Affiliation': 'Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'David J R', 'Initials': 'DJR', 'LastName': 'Steele', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Massachusetts General Hospital, Harvard Medical School Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Germain', 'Affiliation': 'Division of Nephrology, Baystate Medical Center, University of Massachusetts Medical School - Baystate, Springfield, Massachusetts, USA.'}, {'ForeName': 'Jane O', 'Initials': 'JO', 'LastName': 'Schell', 'Affiliation': 'Division of Renal-Electrolyte, Department of General Medicine, Section of Palliative Care and Medical Ethics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Paasche-Orlow', 'Affiliation': 'Section of General Internal Medicine, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Angelo E', 'Initials': 'AE', 'LastName': 'Volandes', 'Affiliation': 'Division of General Medicine, Department of Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}]",American journal of nephrology,['10.1159/000509711']
1315,32764818,"Does type of active workstation matter? A randomized comparison of cognitive and typing performance between rest, cycling, and treadmill active workstations.","Active workstations are associated with improved health outcomes, but differences in cognitive and typing outcomes between the types of active workstations are unclear. We addressed two main questions: (1) Are there differences in cognitive and typing performance between seated and active workstations? (2) Are there differences in cognitive and typing performance between cycling and treadmill workstations, specifically? Participants included 137 healthy young adults (74 female, mean age = 20.8 years) who completed two sessions. At session one (baseline), all participants completed cognitive and typing tests including the Rey-Auditory Verbal Learning Test, Paced Auditory Serial Addition Test, a typing test, and a flanker task while sitting at rest. At session two, participants were randomized to an active workstation group (treadmill or cycling desk) during which they performed the tests listed above in a randomized fashion, using alternate versions when available. Participants showed significantly better attention and cognitive control scores during the active session as compared to the seated session, but worse verbal memory scores during the active session. Participants were faster and more accurate at typing during the active session relative to the seated session. There were no significant differences between cycling or treadmill workstations on any cognitive or typing outcomes. Improvements during active sessions may be influenced by practice effects, although alternate forms were used when possible. We conclude that active workstations do not seem to largely impact cognitive abilities, with the exception of a slight decrease in verbal memory performance. Findings suggest active workstations, whether walking or cycling, are useful to improve physical activity, particularly when completing tasks that do not require verbal memory recall.",2020,"Active workstations are associated with improved health outcomes, but differences in cognitive and typing outcomes between the types of active workstations are unclear.","['Participants included 137 healthy young adults (74 female, mean age = 20.8 years) who completed two sessions']",['active workstation group (treadmill or cycling desk'],"['verbal memory performance', 'verbal memory scores', 'better attention and cognitive control scores', 'health outcomes']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1736830', 'cui_str': 'Workstation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",137.0,0.0902228,"Active workstations are associated with improved health outcomes, but differences in cognitive and typing outcomes between the types of active workstations are unclear.","[{'ForeName': 'Kayla M', 'Initials': 'KM', 'LastName': 'Frodsham', 'Affiliation': 'Department of Psychology, Brigham Young University, Provo, UT, United States of America.'}, {'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Randall', 'Affiliation': 'Department of Psychology, Brigham Young University, Provo, UT, United States of America.'}, {'ForeName': 'Kaylie A', 'Initials': 'KA', 'LastName': 'Carbine', 'Affiliation': 'Department of Psychology, Brigham Young University, Provo, UT, United States of America.'}, {'ForeName': 'Rebekah E', 'Initials': 'RE', 'LastName': 'Rodeback', 'Affiliation': 'Department of Psychology, Brigham Young University, Provo, UT, United States of America.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'LeCheminant', 'Affiliation': 'Department of Nutrition, Dietetics, and Food Science, Brigham Young University, Provo, UT, United States of America.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Larson', 'Affiliation': 'Department of Psychology, Brigham Young University, Provo, UT, United States of America.'}]",PloS one,['10.1371/journal.pone.0237348']
1316,32765876,Oral intake of royal jelly improves anti-cancer effects and suppresses adverse events of molecular targeted therapy by regulating TNF-α and TGF-β in renal cell carcinoma: A preliminary study based on a randomized double-blind clinical trial.,"Molecular targeted therapies are commonly used in patients with metastatic renal cell carcinoma (RCC). However, the efficacy and safety of these therapeutic interventions require enhancement to improve prognosis in these patients. Royal jelly (RJ) has anti-cancer effects and adverse events across a variety of types of malignancy. The present study investigated the detailed mechanism underlying the effects of oral administration of RJ in patients with advanced RCC that were treated with molecular targeted agents in a randomized clinical trial. The study cohort comprised 16 patients treated with RJ and 17 patients treated with a placebo. Serum levels of tumor necrosis factor (TNF)-α and transforming growth factor (TGF)-β were measured using enzyme-linked immunosorbent assays. The results of the present study demonstrated a larger decrease in tumor size upon supplementing patients with RJ following molecular targeted therapy compared with that in patients administered with the placebo. Patients exhibited reduced anorexia and fatigue in the RJ group compared with the placebo group. The relative dose intensity for patients in the RJ group was higher than that in patients in the placebo group. Post- and pre-treatment ratios of the serum levels of TNF-α and TGF-β in patients in the RJ group were lower than those in patients in the placebo group, and these ratios correlated with decreasing tumor size and frequency of anorexia or fatigue in patients. In conclusion, the results of the present study indicated that oral intake of RJ improved the efficacy and safety of molecular targeted therapy in patients with RCC and changed the levels of TNF-α and TGF-β in the serum of patients, which is speculated to serve an important role in RJ-induced biological activities.",2020,"Post- and pre-treatment ratios of the serum levels of TNF-α and TGF-β in patients in the RJ group were lower than those in patients in the placebo group, and these ratios correlated with decreasing tumor size and frequency of anorexia or fatigue in patients.","['patients with RCC', 'patients with advanced RCC', 'renal cell carcinoma', 'patients with metastatic renal cell carcinoma (RCC', '16 patients treated with RJ and 17 patients treated with a']","['TNF-α and TGF-β', 'Royal jelly (RJ', 'RJ', 'royal jelly', 'placebo']","['efficacy and safety', 'serum levels of TNF-α and TGF-β', 'anorexia and fatigue', 'anti-cancer effects', 'Serum levels of tumor necrosis factor (TNF)-α and transforming growth factor ', 'tumor size and frequency of anorexia or fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0073603', 'cui_str': 'royal jelly'}]","[{'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0073603', 'cui_str': 'royal jelly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.135046,"Post- and pre-treatment ratios of the serum levels of TNF-α and TGF-β in patients in the RJ group were lower than those in patients in the placebo group, and these ratios correlated with decreasing tumor size and frequency of anorexia or fatigue in patients.","[{'ForeName': 'Yasuyoshi', 'Initials': 'Y', 'LastName': 'Miyata', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Kyohei', 'Initials': 'K', 'LastName': 'Araki', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Ohba', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Tomhiro', 'Initials': 'T', 'LastName': 'Mastuo', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Yuno', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Mukai', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Asato', 'Initials': 'A', 'LastName': 'Otsubo', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Mitsunari', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Mochizuki', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Sakai', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}]",Molecular and clinical oncology,['10.3892/mco.2020.2099']
1317,32778992,Integrating Tobacco Prevention Skills into an Evidence-Based Intervention for Adolescents with ADHD: Results from a Pilot Efficacy Randomized Controlled Trial.,"Adolescents with attention-deficit/hyperactivity disorder (ADHD) are at high risk for tobacco use, but tobacco use prevention strategies are not regularly incorporated into evidence-based ADHD interventions. We conducted a pilot randomized-controlled trial to determine the feasibility of integrating tobacco use prevention skills into a behavioral treatment for ADHD and to provide preliminary efficacy data comparing a combined (ADHD + tobacco) intervention (N = 40) to an ADHD only intervention (N = 23) on tobacco risk outcomes. Sixty-three adolescents (72% male; 13-17 years) with ADHD and their caregivers were randomly assigned to condition and families were masked to condition. Parent and adolescent ratings were collected at baseline, immediate post-intervention, and at 3- and 9-month follow-up assessments. The combined intervention was (1) implemented with high fidelity (94%), (2) well received by parents and adolescents as evidenced by high levels of treatment attendance (82%) and satisfaction with the intervention, and (3) associated with parent- and adolescent-reported reductions in tobacco use risk. Relative to the ADHD intervention, the combined intervention buffered against increases in tobacco risk, including reduced intentions to smoke and maladaptive social normative beliefs, and increased parental control, family cohesion, and family communication about substance use. Effect sizes at post-treatment were in the small to moderate range. Overall, this study provides preliminary support for a parent-adolescent behavioral treatment supplemented with family-based tobacco prevention strategies. This approach targets families already in treatment for ADHD, reducing barriers that occur when families attend multi-session prevention programs in addition to ADHD treatment.",2020,"The combined intervention was (1) implemented with high fidelity (94%), (2) well received by parents and adolescents as evidenced by high levels of treatment attendance (82%) and satisfaction with the intervention, and (3) associated with parent- and adolescent-reported reductions in tobacco use risk.","['Adolescents with ADHD', 'Adolescents with attention-deficit/hyperactivity disorder (ADHD', 'Sixty-three adolescents (72% male; 13-17\xa0years) with ADHD and their caregivers']",['combined (ADHD + tobacco) intervention'],"['tobacco risk, including reduced intentions to smoke and maladaptive social normative beliefs, and increased parental control, family cohesion, and family communication about substance use', 'Parent and adolescent ratings']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",,0.0726723,"The combined intervention was (1) implemented with high fidelity (94%), (2) well received by parents and adolescents as evidenced by high levels of treatment attendance (82%) and satisfaction with the intervention, and (3) associated with parent- and adolescent-reported reductions in tobacco use risk.","[{'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Corona', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA. racorona@vcu.edu.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Dvorsky', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Romo', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Parks', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Elizaveta', 'Initials': 'E', 'LastName': 'Bourchtein', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Zoe R', 'Initials': 'ZR', 'LastName': 'Smith', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Avila', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Langberg', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-020-00689-6']
1318,32777383,"Rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B).","OBJECTIVE


To describe the rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B).
METHOD


This phase 2 clinical trial was designed to evaluate the use of intranasal oxytocin treatment to improve social difficulties in individuals with autism spectrum disorder (ASD). In total, 290 participants ages 3 to 17 years with a DSM-5 diagnosis of ASD were enrolled to receive 24 weeks of treatment with either oxytocin or a matched placebo at one of seven collaborating sites. Participants were subsequently treated with open-label oxytocin for 24 additional weeks. Post-treatment assessments were done approximately 4 weeks after treatment discontinuation. Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level were measured at baseline, and week 8, 24 and 36 to explore potential relationships between these biomarkers and treatment response.
RESULTS


This report describes the rationale, design, and methods of the SOARS-B clinical trial.
CONCLUSIONS


There is a tremendous unmet need for safe and effective pharmacological treatment options that target the core symptoms of ASD. Several studies support the hypothesis that intranasal oxytocin could improve social orienting and the salience of social rewards in ASD, thereby enhancing reciprocal social behaviors. However, due to conflicting results from a number of pilot studies on the prosocial effects of exogenous oxytocin, this hypothesis remains controversial and inconclusive. SOARS-B is the best powered study to date to address this hypothesis and promises to improve our understanding of the safety and efficacy of intranasal oxytocin in the treatment of social deficits in children with ASD.",2020,"Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level were measured at baseline, week 8, 24 and 36 to explore potential relationships between these biomarkers and treatment response.
","['individuals with autism spectrum disorder (ASD', 'children with ASD', '290 participants ages 3 to 17\u202fyears with a DSM-5 diagnosis of ASD']","['oxytocin', 'intranasal oxytocin', 'Oxytocin', 'open-label oxytocin', 'oxytocin or a matched placebo']","['Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level', 'Reciprocal Social Behaviors (SOARS-B', 'reciprocal social behaviors (SOARS-B', 'social orienting', 'social difficulties']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0069841', 'cui_str': 'Oxytocin Receptor'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",290.0,0.0611497,"Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level were measured at baseline, week 8, 24 and 36 to explore potential relationships between these biomarkers and treatment response.
","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Spanos', 'Affiliation': 'Duke Center for Autism and Brain Development, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America. Electronic address: marina.spanos@duke.edu.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Chandrasekhar', 'Affiliation': 'Duke Center for Autism and Brain Development, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Soo-Jeong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': ""Seattle Children's Autism Center, Department of Psychiatry and Behavioral Sciences, University of Washington; Seattle, WA, United States of America.""}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Hamer', 'Affiliation': 'Departments of Psychiatry and Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Bryan H', 'Initials': 'BH', 'LastName': 'King', 'Affiliation': ""Department of Psychiatry and Weill Institute for Neurosciences, University of California San Francisco, UCSF Benioff Children's Hospitals, San Francisco, CA, United States of America.""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'McDougle', 'Affiliation': 'Lurie Center for Autism, Massachusetts General Hospital; Department of Psychiatry, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Sanders', 'Affiliation': 'Neuroscience Product Development, F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Simon G', 'Initials': 'SG', 'LastName': 'Gregory', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University School of Medicine, Durham, NC, United States of America; Department of Neurology, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kolevzon', 'Affiliation': 'Seaver Autism Center for Research and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Veenstra-VanderWeele', 'Affiliation': 'Department of Psychiatry, Columbia University; New York State Psychiatric Institute; Center for Autism and the Developing Brain, New York-Presbyterian Hospital, United States of America.'}, {'ForeName': 'Linmarie', 'Initials': 'L', 'LastName': 'Sikich', 'Affiliation': 'Duke Center for Autism and Brain Development, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106103']
1319,32773519,CORR Insights®: Does Virtual Reality Improve Procedural Completion and Accuracy in an Intramedullary Tibial Nail Procedure? A Randomized Control Trial.,,2020,,[],['CORR Insights®'],[],[],"[{'cui': 'C0233820', 'cui_str': 'Insight'}]",[],,0.0649477,,"[{'ForeName': 'Brian B', 'Initials': 'BB', 'LastName': 'Gilmer', 'Affiliation': 'B. B. Gilmer, Mammoth Orthopedic Institute, Mammoth Lakes, CA, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001432']
1320,32783178,Treatment effect of palbociclib plus endocrine therapy by prognostic and intrinsic subtype and biomarker analysis in patients with bone-only disease: a joint analysis of PALOMA-2 and PALOMA-3 clinical trials.,"PURPOSE


This analysis evaluated the relationship between treatment-free interval (TFI, in PALOMA-2)/disease-free interval (DFI, in PALOMA-3) and progression-free survival (PFS) and overall survival (OS, in PALOMA-3), treatment effect in patients with bone-only disease, and whether intrinsic subtype affects PFS in patients receiving palbociclib.
METHODS


Data were from phase 3, randomized PALOMA-2 and PALOMA-3 clinical studies of hormone receptor‒positive/human epidermal growth factor receptor 2‒negative (HR+ /HER2-) advanced breast cancer (ABC) patients receiving endocrine therapy plus palbociclib or placebo. Subpopulation treatment effect pattern plot (STEPP) analysis evaluated the association between DFI and PFS and OS. PFS by luminal subtype and cyclin-dependent kinase (CDK) 4/6 or endocrine pathway gene expression levels were evaluated in patients with bone-only disease; median PFS and OS were estimated by the Kaplan-Meier method.
RESULTS


Median durations of TFI were 37.1 and 30.9 months (PALOMA-2) and DFI were 49.2 and 52.0 months (PALOMA-3) in the palbociclib and placebo groups, respectively. Among the PALOMA-2 biomarker population (n = 454), 23% had bone-only disease; median PFS was longer with palbociclib versus placebo (31.3 vs 11.2 months; hazard ratio, 0.41; 95% CI 0.25‒0.69). The interaction effect of bone-only versus visceral disease subgroups on median PFS with palbociclib was not significant (P = 0.262). Among the PALOMA-3 biomarker population (n = 302), 27% had bone-only disease. STEPP analyses showed that palbociclib PFS benefit was not affected by DFI, and that palbociclib OS effect may be smaller in patients with short DFIs. Among patients who provided metastatic tumor tissues (n = 142), regardless of luminal A (hazard ratio, 0.23; 95% CI 0.11‒0.47; P = 0.0000158) or luminal B (hazard ratio, 0.26; 95% CI 0.12‒0.56; P = 0.000269) subtype, palbociclib improved PFS versus placebo.
CONCLUSIONS


These findings support palbociclib plus endocrine therapy as standard of care for HR+ /HER2- ABC patients, regardless of baseline TFI/DFI or intrinsic molecular subtype, including patients with bone-only disease.
TRIAL REGISTRATION


Pfizer (clinicaltrials.gov:NCT01740427, NCT01942135).",2020,The interaction effect of bone-only versus visceral disease subgroups on median PFS with palbociclib was not significant (P = 0.262).,"['advanced breast cancer (ABC) patients receiving', 'patients with short DFIs', 'patients with bone-only disease']","['palbociclib plus endocrine therapy', 'endocrine therapy plus palbociclib or placebo', 'plot (STEPP', 'hormone receptor‒positive/human epidermal growth factor receptor 2‒negative (HR+\u2009/HER2', 'placebo']","['bone-only disease; median PFS', 'DFI and PFS and OS', '4/6 or endocrine pathway gene expression levels', 'bone-only disease', 'median PFS with palbociclib', 'PFS by luminal subtype and cyclin-dependent kinase (CDK', 'treatment-free interval (TFI, in PALOMA-2)/disease-free interval (DFI, in PALOMA-3) and progression-free survival (PFS) and overall survival', 'Median durations of TFI', 'palbociclib PFS benefit']","[{'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C1509244', 'cui_str': 'human epidermal growth factor'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0243045', 'cui_str': 'cdk Proteins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.323609,The interaction effect of bone-only versus visceral disease subgroups on median PFS with palbociclib was not significant (P = 0.262).,"[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, 2825 Santa Monica Blvd, Suite 200, Santa Monica, CA, USA. RFinn@mednet.ucla.edu.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Cristofanilli', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, 710 N Fairbanks Ct, Suite 8-250A, Chicago, IL, USA.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Ettl', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Klinikum Rechts der Isar, Technical University of Munich, Ismaninger Str 22, 81675, Munich, Germany.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Gelmon', 'Affiliation': 'British Columbia Cancer Agency, 675 West 10th Ave, Vancouver, BC, Canada.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'IEO European Institute of Oncology, IRCCS, Via Ripamonti 435, Milan, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Giorgetti', 'Affiliation': 'Pfizer Italia, Via Anna Maria Mozzoni, 12, Milan, Italy.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Gauthier', 'Affiliation': 'Pfizer Inc, 525 Market Street, San Francisco, CA, USA.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Pfizer Inc, 10646 Science Center Dr, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Dongrui R', 'Initials': 'DR', 'LastName': 'Lu', 'Affiliation': 'Pfizer Inc, 10646 Science Center Dr, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Inc, 10646 Science Center Dr, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Cynthia Huang', 'Initials': 'CH', 'LastName': 'Bartlett', 'Affiliation': 'Pfizer Inc, 500 Arcola Rd, Collegeville, PA, USA.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Slamon', 'Affiliation': 'Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, 2825 Santa Monica Blvd, Suite 200, Santa Monica, CA, USA.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Turner', 'Affiliation': 'Royal Marsden Hospital and Institute of Cancer Research, Fulham Rd, London, SW3 6JJ, UK.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California San Francisco Comprehensive Center, 1600 Divisadero St, San Francisco, CA, USA.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05782-4']
1321,32788567,Levosimendan in the treatment of patients with acute cardiac conditions: an expert opinion of the Association of Intensive Cardiac Care of the Polish Cardiac Society.,"Levosimendan is a new inodilator which involves 3 main mechanisms: increases the calcium sensitivity of cardiomyocytes, acts as a vasodilator due to the opening of potassium channels, and has a cardioprotective effect. Levosimendan is mainly used in the treatment of acute decompensated heart failure (class IIb recommendation according to the European Society of Cardiology guidelines). However, numerous clinical trials indicate the validity of repeated infusions of levosimendan in patients with stable heart failure as a bridge therapy to heart transplantation, and in patients with accompanying right ventricular heart failure and pulmonary hypertension. Due to the complex mechanism of action, including the cardioprotective and anti- -aggregating effect, the use of levosimendan may be particularly beneficial in acute coronary syndromes, preventing the occurrence of acute heart failure. There are data indicating that levosimendan administered prior to cardiac surgery may improve outcomes in patients with severely impaired left ventricular function. The multidirectional mechanism of action also affects other organs and systems. The positive effect of levosimendan in the treatment of cardiorenal and cardiohepatic syndromes has been shown. It has a safe and predictable profile of action, does not induce tolerance, and shows no adverse effects affecting patients survival or prognosis. However, with inconclusive results of previous studies, there is aneed for awell-designed multicenter randomized placebo-‑controlled study, including an adequately large group of outpatients with chronic advanced systolic heart failure.",2020,"Levosimendan has a safe and predictable profile of action, does not induce tolerance, and shows no adverse effects affecting patients survival or prognosis.","['patients with accompanying right ventricle heart failure and pulmonary hypertension', 'patients with stable heart failure', 'patients with acute coronary syndromes', 'patients with severely impaired left ventricle function', 'patients with acute cardiac conditions', 'outpatients with chronic advanced systolic heart failure']","['levosimendan', 'Levosimendan', 'levosimandan', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225883', 'cui_str': 'Right cardiac ventricular structure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0225897', 'cui_str': 'Left cardiac ventricular structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1135191', 'cui_str': 'Systolic heart failure'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0197177,"Levosimendan has a safe and predictable profile of action, does not induce tolerance, and shows no adverse effects affecting patients survival or prognosis.","[{'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Tycińska', 'Affiliation': 'Department of Cardiology, Medical University of Białystok, Białystok, Poland. agnieszka.tycinska@gmail.com'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Gierlotka', 'Affiliation': 'Department of Cardiology, University Hospital in Opole, Institute of Medical Sciences, University of Opole, Opole, Poland'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Bugajski', 'Affiliation': 'Department of Cardiology, University Hospital in Opole, Institute of Medical Sciences, University of Opole, Opole, Poland'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Deja', 'Affiliation': 'Department of Cardiac Surgery, Faculty of Medical Sciences in Katowice, Medical University of Silesia, Katowice, Poland'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Depukat', 'Affiliation': 'Department of Cardiology and Cardiovascular Interventions, University Hospital, Kraków, Poland'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Gruchała', 'Affiliation': '1st Department of Cardiology, Medical University of Gdańsk, Gdańsk, Poland'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Grześk', 'Affiliation': 'Department of Cardiology and Clinical Pharmacology, Faculty of Health Sciences Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland'}, {'ForeName': 'Jarosław D', 'Initials': 'JD', 'LastName': 'Kasprzak', 'Affiliation': 'I Department and Chair of Cardiology, Bieganski Hospital, Medical University of Lodz, Łódź, Poland'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kubica', 'Affiliation': 'Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Kucewicz-Czech', 'Affiliation': 'Department of Cardiac Anaesthesiology and Intensive Therapy, Medical University of Silesia, Katowice, Poland'}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Leszek', 'Affiliation': 'Department of Heart Failure and Transplantology, National Institute of Cardiology, Warsaw, Poland'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Płonka', 'Affiliation': 'Department of Cardiology, University Hospital in Opole, Institute of Medical Sciences, University of Opole, Opole, Poland'}, {'ForeName': 'Bożena', 'Initials': 'B', 'LastName': 'Sobkowicz', 'Affiliation': 'Department of Cardiology, Medical University of Białystok, Białystok, Poland'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Straburzyńska-Migaj', 'Affiliation': '1st Department of Cardiology, University of Medical Sciences in Poznan, University Hospital of Lord’s Transfiguration, Poznań, Poland'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Wilk', 'Affiliation': 'Department of Cardiology, Medical University of Białystok, Białystok, Poland'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Zawiślak', 'Affiliation': 'Intensive Cardiac Care Unit, University Hospital, Kraków, Poland'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zymliński', 'Affiliation': 'Department of Heart Diseases, Wroclaw Medical University, Wrocław, Poland; Centre for Heart Diseases, University Hospital, Wrocław, Poland'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Stępińska', 'Affiliation': 'Department of Intensive Cardiac Therapy, National Institute of Cardiology, Warsaw, Poland'}]",Kardiologia polska,['10.33963/KP.15551']
1322,32784346,"Intravenous vortioxetine to accelerate onset of effect in major depressive disorder: a 7-day randomized, double-blind, placebo-controlled exploratory study.","This 7-day randomized, double-blind, placebo-controlled fixed-dose study (NCT03766867) explored the potential for accelerating the onset of antidepressant efficacy of single-dose intravenous (IV) vortioxetine at oral vortioxetine treatment initiation. Patients (ages 18-65 years) hospitalized per standard-of-care with major depressive disorder, who were currently treated with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor for a major depressive episode [Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 30], received one dose of single-blind IV placebo (1-day placebo lead-in period) before being randomly switched to either single-dose IV vortioxetine 25 mg plus daily oral vortioxetine 10 mg (n = 39), or IV placebo plus daily oral placebo (n = 41). In the placebo lead-in period, patients improved slightly by 0.6 MADRS-6 point; however, at day 1 after randomization, both treatment groups had improved by approximately 3 MADRS-6 points (mean difference = -0.8; P = 0.263), the study thus not meeting its primary endpoint. Similar results were seen for other outcomes except a numerically larger improvement in anxiety symptoms with vortioxetine vs placebo. Pharmacokinetic data confirmed that IV vortioxetine facilitated reaching steady-state plasma concentration within 24 h. IV plus oral vortioxetine was well tolerated, with low levels of nausea as the most common adverse event.",2020,Similar results were seen for other outcomes except a numerically larger improvement in anxiety symptoms with vortioxetine vs placebo.,"['Patients (ages 18-65\u2009years) hospitalized per standard-of-care with major depressive disorder, who were currently treated with a', 'for a major depressive episode [Montgomery-Åsberg Depression Rating Scale (MADRS) total score\u2009≥\u200930', 'major depressive disorder']","['vortioxetine 25\u2009mg plus daily oral vortioxetine', 'vortioxetine', 'vortioxetine vs placebo', 'placebo (1-day placebo lead-in period', 'Intravenous vortioxetine', 'selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor', 'placebo plus daily oral placebo', 'single-dose intravenous (IV) vortioxetine', 'placebo']","['nausea', 'anxiety symptoms', 'reaching steady-state plasma concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C1319313', 'cui_str': 'Norepinephrine reuptake inhibitor-containing product'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.68684,Similar results were seen for other outcomes except a numerically larger improvement in anxiety symptoms with vortioxetine vs placebo.,"[{'ForeName': 'Elmars', 'Initials': 'E', 'LastName': 'Rancans', 'Affiliation': 'Department of Psychiatry and Narcology, Riga Stradins University, Riga, Latvia.'}, {'ForeName': 'Janos', 'Initials': 'J', 'LastName': 'Zambori', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Dalsgaard', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Baayen', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Areberg', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ettrup', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Florea', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}]",International clinical psychopharmacology,['10.1097/YIC.0000000000000326']
1323,32784956,Pilot Testing of a Nudge-Based Digital Intervention (Welbot) to Improve Sedentary Behaviour and Wellbeing in the Workplace.,"Welbot is a nudge-based digital intervention that aims to reduce sedentary behaviour and improve physical and mental wellbeing at work. The purpose of this study was to pilot test the Welbot intervention. Forty-one (6M/35F) University staff ( M  age = 43-years) participated in this study, which was a single arm repeated measures trial conducted over three weeks of intervention. The primary outcome was sedentary behaviour (measured subjectively and objectively) and secondary outcomes included: mental wellbeing, procrastination, depression, anxiety and stress, and work engagement. A subset of participants ( n  = 6) wore an ActivPAL to objectively measure activity data, while another subset of participants ( n  = 6) completed a qualitative semi-structured interview to ascertain experiences of using Welbot. Following the intervention, a Friedman non-parametric test revealed that participants self-reported significantly less time sitting and more time standing and objectively recorded more steps at the week-1 follow-up. A series of paired  t -tests exhibited that changes in all secondary outcomes were in the expected direction. However, only improvements in depression, anxiety, and stress were significant. After using Welbot, thematic analysis demonstrated that participants perceived they had a positive behaviour change, increased awareness of unhealthy behaviours at work, and provided suggestions for intervention improvement. Overall, findings provided indications of the potential positive impact Welbot may have on employees' wellbeing, however, limitations are noted. Recommendations for intervention improvement including personalisation (e.g., individual preferences for nudges and the option to sync Welbot with online calendars) and further research into how users engage with Welbot are provided.",2020,"Following the intervention, a Friedman non-parametric test revealed that participants self-reported significantly less time sitting and more time standing and objectively recorded more steps at the week-1 follow-up.","['Forty-one (6M/35F', 'University staff ( M  age']",['Nudge-Based Digital Intervention (Welbot'],"['sedentary behaviour and improve physical and mental wellbeing', 'depression, anxiety, and stress', 'time sitting and more time standing', 'Sedentary Behaviour and Wellbeing', 'sedentary behaviour (measured subjectively and objectively) and secondary outcomes included: mental wellbeing, procrastination, depression, anxiety and stress, and work engagement', 'positive behaviour change, increased awareness of unhealthy behaviours']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0871142', 'cui_str': 'Procrastination'}, {'cui': 'C4505268', 'cui_str': 'Employee Engagement'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",,0.0571395,"Following the intervention, a Friedman non-parametric test revealed that participants self-reported significantly less time sitting and more time standing and objectively recorded more steps at the week-1 follow-up.","[{'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Haile', 'Affiliation': 'Psychological Sciences and Health, Graham Hills Building, University of Strathclyde, Glasgow G1 1QX, Scotland, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Kirk', 'Affiliation': 'Psychological Sciences and Health, Graham Hills Building, University of Strathclyde, Glasgow G1 1QX, Scotland, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Cogan', 'Affiliation': 'Psychological Sciences and Health, Graham Hills Building, University of Strathclyde, Glasgow G1 1QX, Scotland, UK.'}, {'ForeName': 'Xanne', 'Initials': 'X', 'LastName': 'Janssen', 'Affiliation': 'Psychological Sciences and Health, Graham Hills Building, University of Strathclyde, Glasgow G1 1QX, Scotland, UK.'}, {'ForeName': 'Ann-Marie', 'Initials': 'AM', 'LastName': 'Gibson', 'Affiliation': 'Psychological Sciences and Health, Graham Hills Building, University of Strathclyde, Glasgow G1 1QX, Scotland, UK.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'MacDonald', 'Affiliation': 'Psychological Sciences and Health, Graham Hills Building, University of Strathclyde, Glasgow G1 1QX, Scotland, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17165763']
1324,32786112,Is pelvic floor muscle training able to alter the response of cardiovascular autonomic modulation and provide a possible cardiovascular benefit to pregnant women?,"AIMS


To evaluate the acute and chronic effect of an exercise protocol of pelvic floor muscles (PFMs) contraction on the heart period (HP) and systolic arterial pressure (SAP) variabilities and baroreflex sensitivity (BRS) at rest in pregnant women; and to evaluate if this progressive exercise protocol was well-tolerated by the pregnant women studied.
METHODS


We evaluated 48 women at 18 weeks of pregnancy by vaginal palpation, vaginal manometry, and cardiopulmonary exercise test. They were divided in control (CG; 31.75 ± 3.91 years) and training groups (TG; 30.71 ± 3.94 years). At 19 and 36 weeks of pregnancy, electrocardiogram and noninvasive peripheral SAP data were collected at rest before and after 10 PFM contractions. TG performed PFMT from the 20th to the 36th week. HP and SAP variabilities were analyzed by spectral and symbolic analysis. The baroreflex was evaluated by cross-spectral analysis between the HP and SAP series.
RESULTS


The groups did not differ in relation to VO 2  , HP and SAP variabilities, and BRS at the beginning of the protocol. TG increased the endurance of the PFM after training. PFM contraction did not change the HP and SAP variabilities, and BRS at the 18th week. After the training, the TG presented lower SAP mean, lower BF of SAP variability, and higher BRS than CG.
CONCLUSIONS


Acute PFM contractions did not alter HP and SAP variabilities and BRS, but PFMT resulted in a lower SAP mean and higher BRS in trained pregnant when compared to the untrained.",2020,"After the training, the TG presented lower SAP mean, lower BF of SAP variability, and higher BRS than CG.
","['pregnant women studied', '48 women at 18\u2009weeks of pregnancy by vaginal palpation, vaginal manometry, and cardiopulmonary exercise test', 'pregnant women']","['progressive exercise protocol', 'exercise protocol of pelvic floor muscles (PFMs) contraction']","['HP and SAP variabilities, and BRS', 'pregnancy, electrocardiogram and noninvasive peripheral SAP data', 'relation to VO 2  , HP and SAP variabilities, and BRS', 'HP and SAP variabilities', 'heart period (HP) and systolic arterial pressure (SAP) variabilities and baroreflex sensitivity (BRS', 'HP and SAP variabilities and BRS', 'SAP mean and higher BRS', 'PFM contraction', 'SAP mean, lower BF of SAP variability']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0024751', 'cui_str': 'Manometry'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1868598', 'cui_str': 'Enlarged parietal foramina'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",48.0,0.0360243,"After the training, the TG presented lower SAP mean, lower BF of SAP variability, and higher BRS than CG.
","[{'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'da Silva Corrêa', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Rodovia Washington Luís, km 235, Monjolinho, São Carlos, São Paulo, Brazil.""}, {'ForeName': 'Aparecida M', 'Initials': 'AM', 'LastName': 'Catai', 'Affiliation': 'Cardiovascular Physiotherapy Laboratory, Physical Therapy Department, Rodovia Washington Luís, km 235, Monjolinho, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Juliana C', 'Initials': 'JC', 'LastName': 'Milan-Mattos', 'Affiliation': 'Cardiovascular Physiotherapy Laboratory, Physical Therapy Department, Rodovia Washington Luís, km 235, Monjolinho, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Porta', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Driusso', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Rodovia Washington Luís, km 235, Monjolinho, São Carlos, São Paulo, Brazil.""}]",Neurourology and urodynamics,['10.1002/nau.24481']
1325,32791086,Proteinuria Reduction and Kidney Survival in Focal Segmental Glomerulosclerosis.,"RATIONALE & OBJECTIVE


Remission of proteinuria has been shown to be associated with lower rates of kidney disease progression among people with focal segmental glomerulosclerosis (FSGS). The goal of this study was to evaluate whether reductions in proteinuria after treatment are associated with greater kidney survival.
STUDY DESIGN


Cohort analysis of clinical trial participants.
SETTING & PARTICIPANTS


Patients with steroid-resistant FSGS enrolled in a randomized treatment trial that compared cyclosporine with mycophenolate mofetil plus dexamethasone.
PREDICTORS


Reduction in proteinuria measured during 26 weeks after initiating treatment.
OUTCOMES


Repeated assessments of estimated glomerular filtration rate (eGFR) and time to a composite outcome of kidney failure or death assessed between 26 weeks and 54 months after randomization.
ANALYTICAL APPROACH


Multivariable linear mixed-effects models with participant-specific slope and intercept to estimate the association of change in proteinuria over 26 weeks while receiving treatment with the subsequent slope of change in eGFR. Multivariable time-varying Cox proportional hazards models were used to estimate the association of changes in proteinuria with time to the composite outcome.
RESULTS


138 of 192 trial participants were included. Changes in proteinuria over 26 weeks were significantly related to eGFR slope. A 1-unit reduction in log-transformed urinary protein-creatinine ratio was associated with a 3.90mL/min/1.73m 2  per year increase in eGFR (95% CI, 2.01-5.79). This difference remained significant after adjusting for complete remission. There was an analogous relationship between time-varying proteinuria and time to the composite outcome: the HR per 1-unit reduction in log-transformed urinary protein-creatinine ratio was 0.23 (95% CI, 0.12-0.44).
LIMITATIONS


Limited to individuals with steroid-resistant FSGS followed up for a maximum of 5 years.
CONCLUSIONS


These findings provide evidence for the benefit of urinary protein reduction in FSGS. Reductions in proteinuria warrant further evaluation as a potential surrogate for preservation of kidney function that may inform the design of future clinical trials.",2020,"There was an analogous relationship between time-varying proteinuria and time to end-stage kidney disease: the HR for ESKD or death per 1 unit reduction in log-transformed urinary protein-creatinine ratio was 0.23 (95% CI=0.12 to 0.44).
","['people with focal segmental glomerulosclerosis (FSGS', 'individuals with steroid-resistant FSGS followed for a maximum of five-years', '138 of 192 trial participants were included', 'Patients with steroid resistant FSGS enrolled']",['cyclosporine to mycophenolate mofetil plus dexamethasone'],"['glomerular filtration rate (eGFR) and, time to end-stage kidney disease (ESKD) or death', 'log-transformed urinary protein:creatinine ratio', 'Proteinuria Reduction and Kidney Survival', 'Changes in proteinuria']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017668', 'cui_str': 'Focal glomerular sclerosis'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.167968,"There was an analogous relationship between time-varying proteinuria and time to end-stage kidney disease: the HR for ESKD or death per 1 unit reduction in log-transformed urinary protein-creatinine ratio was 0.23 (95% CI=0.12 to 0.44).
","[{'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Troost', 'Affiliation': 'Michigan Institute for Clinical and Health Research, University of Michigan, Ann Arbor, MI. Electronic address: troostj@med.umich.edu.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Trachtman', 'Affiliation': 'Division of Nephrology, Department of Pediatrics, New York University Langone Health, New York, NY.'}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Kaskel', 'Affiliation': ""Division of Pediatric Nephrology, Children's Hospital at Montefiore, Bronx, NY.""}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Friedman', 'Affiliation': 'Division of Nephrology, Department of Pediatrics, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Marva M', 'Initials': 'MM', 'LastName': 'Moxey-Mims', 'Affiliation': ""Division of Nephrology, Children's National Hospital, Department of Pediatrics, The George Washington University School of Medicine, Washington, DC.""}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Fine', 'Affiliation': 'Stony Brook University Medical Center, School of Medicine, Stony Brook, NY.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Gassman', 'Affiliation': 'Department of Quantitative Health Sciences at the Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Kopp', 'Affiliation': 'Kidney Disease Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Liron', 'Initials': 'L', 'LastName': 'Walsh', 'Affiliation': 'Goldfinch Bio, Cambridge, MA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc, New York, NY.'}, {'ForeName': 'Debbie S', 'Initials': 'DS', 'LastName': 'Gipson', 'Affiliation': 'Division of Nephrology, Department of Pediatrics, University of Michigan, Ann Arbor, MI.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2020.04.014']
1326,32798022,Resection following concurrent chemotherapy and high-dose radiation for stage IIIA non-small cell lung cancer.,"OBJECTIVE


Concern exists regarding surgery after thoracic radiation. We aimed to assess early results of anatomic resection following induction therapy with platinum-based chemotherapy and full-dose thoracic radiation for resectable N2+ stage IIIA non-small cell lung cancer.
METHODS


Two prospective trials were recently conducted by NRG Oncology in patients with resectable N2+ stage IIIA non-small cell lung cancer with the primary end point of mediastinal node sterilization following concurrent full-dose chemoradiotherapy (Radiation Therapy Oncology Group trials 0229 and 0839). All surgeons demonstrated postinduction resection expertise. Induction consisted of weekly carboplatin (area under the curve, 2.0) and paclitaxel (50 mg/m 2 ) and concurrent thoracic radiation 60 Gy (0839)/61.2 Gy (0229) in 30 fractions. Patients in study 0839 were randomized 2:1 to weekly panitumumab + chemoradiotherapy or chemoradiotherapy alone during induction. Primary results were similar in all treatment arms and reported previously. Short-term surgical outcomes are reported here.
RESULTS


One hundred twenty-six patients enrolled; 93 (74%) had anatomic resection, 77 underwent lobectomy, and 16 underwent extended resection. Microscopically margin-negative resections occurred in 85 (91%). Fourteen (15%) resections were attempted minimally invasively, including 2 converted without event. Grade 3 or 4 surgical adverse events were reported in 26 (28%), 30-day mortality in 4 (4%) and 90-day mortality in 5 (5%). Patients undergoing extended resection experienced similar rates of grade 3 or 4 adverse events (odds ratio, 0.95; 95% confidence interval, 0.42-3.8) but higher 30-day (1.3% vs 18.8%) (odds ratio, 17.54; 95% confidence interval, 1.75-181.8) and 90-day mortality (2.6% vs 18.8%) (odds ratio, 8.65; 95% confidence interval, 1.3-56.9).
CONCLUSIONS


Lobectomy was performed safely following full-dose concurrent chemoradiotherapy in these multi-institutional prospective trials; however, increased mortality was noted with extended resections.",2020,"Patients undergoing extended resection experienced similar rates of grade 3 or 4 adverse events (odds ratio, 0.95; 95% confidence interval, 0.42-3.8) but higher 30-day (1.3% vs 18.8%) (odds ratio, 17.54; 95% confidence interval, 1.75-181.8) and 90-day mortality (2.6% vs 18.8%) (odds ratio, 8.65; 95% confidence interval, 1.3-56.9).
","['patients with resectable N2+ stage IIIA non-small cell lung cancer with the primary end point of mediastinal node sterilization following concurrent full-dose chemoradiotherapy (Radiation Therapy Oncology Group trials 0229 and 0839', 'One hundred twenty-six patients enrolled; 93 (74%) had anatomic resection, 77 underwent lobectomy, and 16 underwent extended resection', 'stage IIIA non-small cell lung cancer']","['anatomic resection following induction therapy with platinum-based chemotherapy and full-dose thoracic radiation', 'paclitaxel', 'carboplatin', 'concurrent chemotherapy and high-dose radiation', 'panitumumab\xa0+\xa0chemoradiotherapy or chemoradiotherapy']","['90-day mortality', 'Microscopically margin-negative resections', 'rates of grade 3 or 4 adverse events', 'mortality', '30-day mortality', 'Grade 3 or 4 surgical adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278983', 'cui_str': 'Non-small cell lung cancer stage IIIA'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0588055', 'cui_str': 'Mediastinal lymph node group'}, {'cui': 'C0038280', 'cui_str': 'Sterilization'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",839.0,0.482473,"Patients undergoing extended resection experienced similar rates of grade 3 or 4 adverse events (odds ratio, 0.95; 95% confidence interval, 0.42-3.8) but higher 30-day (1.3% vs 18.8%) (odds ratio, 17.54; 95% confidence interval, 1.75-181.8) and 90-day mortality (2.6% vs 18.8%) (odds ratio, 8.65; 95% confidence interval, 1.3-56.9).
","[{'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Donington', 'Affiliation': 'Department of Department of Surgery, University of Chicago Medicine and Biologic Sciences, Chicago, Ill. Electronic address: jdonington@uchicago.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Paulus', 'Affiliation': 'Department of Department of Surgery, University of Chicago Medicine and Biologic Sciences, Chicago, Ill.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Edelman', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, University of Maryland Medical Center, Baltimore, Md.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Krasna', 'Affiliation': 'Department of Surgery, Jersey Shore University Medical Center, Neptune City, NJ.'}, {'ForeName': 'Quynh-Thu', 'Initials': 'QT', 'LastName': 'Le', 'Affiliation': 'Department of Radiation Oncology, Stanford Cancer Institute, Stanford, Calif.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Suntharalingam', 'Affiliation': 'Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Md.'}, {'ForeName': 'Billy W', 'Initials': 'BW', 'LastName': 'Loo', 'Affiliation': 'Department of Radiation Oncology, Stanford Cancer Institute, Stanford, Calif.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, Pa; Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Bradley', 'Affiliation': 'Department of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, Ga.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2020.03.171']
1327,32804282,Shoulder amplitude movement does not influence postoperative wound complications after breast cancer surgery: a randomized clinical trial.,"PURPOSE


The goal of this study is to evaluate the influence of shoulder exercises with restricted amplitude movement (RAM) or free amplitude movement (FAM) performed from the first postoperative day (1st POD) on the incidence of surgical wound complications (SWC) in breast cancer.
METHODS


This study comprises a randomized clinical trial with an intention-to-treat analysis including 465 women aged 18 to 79, who underwent curative surgery for breast cancer. Participants were submitted to perform free amplitude movement (FAM) or restricted amplitude movement (RAM) shoulder exercises, until the 30th postoperative day. The outcome measures were the SWC: seroma, dehiscence, necrosis, infection, hematoma and bruise.
RESULTS


461 participants completed the follow-up. Thirty days after surgery, 63.8% of the women presented some surgical wound complication, with necrosis (39.3%) and seroma (30.8%) as the most frequent. No statistically significant differences in SWC according to postoperative amplitude shoulder exercise (FAM vs RAM), even after a stratified analysis by type of surgery (segmentectomy vs mastectomy) or axillary approach (axillary lymphadenectomy versus sentinel lymph node biopsy) were observed.
CONCLUSION


FAM exercises do not increase the incidence of postoperative wound complications compared to RAM exercises.
TRIAL REGISTRATION


NCT03796845.",2020,"No statistically significant differences in SWC according to postoperative amplitude shoulder exercise (FAM vs RAM), even after a stratified analysis by type of surgery (segmentectomy vs mastectomy) or axillary approach (axillary lymphadenectomy versus sentinel lymph node biopsy) were observed.
","['breast cancer', '465 women aged 18 to 79, who underwent curative surgery for breast cancer', 'breast cancer surgery', '461 participants completed the follow-up']","['free amplitude movement (FAM) or restricted amplitude movement (RAM) shoulder exercises', 'FAM exercises', 'Shoulder amplitude movement', 'shoulder exercises with restricted amplitude movement (RAM) or free amplitude movement (FAM']","['postoperative wound complications', 'seroma', 'surgical wound complications (SWC', 'surgical wound complication, with necrosis', 'SWC: seroma, dehiscence, necrosis, infection, hematoma and bruise']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0454323', 'cui_str': 'Shoulder exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]","[{'cui': 'C0877305', 'cui_str': 'Postoperative wound complication'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0009938', 'cui_str': 'Contusion'}]",465.0,0.162905,"No statistically significant differences in SWC according to postoperative amplitude shoulder exercise (FAM vs RAM), even after a stratified analysis by type of surgery (segmentectomy vs mastectomy) or axillary approach (axillary lymphadenectomy versus sentinel lymph node biopsy) were observed.
","[{'ForeName': 'Clarice Gomes Chagas', 'Initials': 'CGC', 'LastName': 'Teodózio', 'Affiliation': 'Clinical Research Division, Brazilian National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Liz de Oliveira', 'Initials': 'LO', 'LastName': 'Marchito', 'Affiliation': 'Clinical Research Division, Brazilian National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Erica Alves Nogueira', 'Initials': 'EAN', 'LastName': 'Fabro', 'Affiliation': 'Physiotherapy Department, Brazilian National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Flávia Oliveira', 'Initials': 'FO', 'LastName': 'Macedo', 'Affiliation': 'Physiotherapy Department, Brazilian National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Suzana Sales', 'Initials': 'SS', 'LastName': 'de Aguiar', 'Affiliation': 'Clinical Research Division, Brazilian National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Luiz Claudio Santos', 'Initials': 'LCS', 'LastName': 'Thuler', 'Affiliation': 'Clinical Research Division, Brazilian National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Bergmann', 'Affiliation': 'Clinical Research Division, Brazilian National Cancer Institute, Rio de Janeiro, Brazil. abergmann@inca.gov.br.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05826-9']
1328,32799849,"Protocol for Minute Calisthenics: a randomized controlled study of a daily, habit-based, bodyweight resistance training program.","BACKGROUND


Resistance-training (RT) provides significant health benefits. However, roughly 3/4 of adults in the United States do not meet current Physical Activity Guidelines in this regard. There has been a call for research examining the effectiveness of interventions to increase participation in physical activity and to better understand the dose response relationship upon health outcomes. Studies are needed that assess the effectiveness of RT programs that are time-efficient and simple to perform. This fully-powered, randomized controlled study will assess a habit-based RT program consisting of one set of push-ups, angled-rows, and bodyweight-squats performed every weekday for 12-24 weeks in untrained individuals.
METHODS


Forty-60 untrained osteopathic medical students and college/university employees who work in an office setting will be recruited and randomized (1:1) to an intervention or waitlist control group. After 12-week follow-up assessment, the intervention group will continue the program and the control group will initiate the program for 12 weeks. In addition to the equipment and training needed to safely perform the exercises, all participants will receive training in the Tiny Habits® Method (THM) and digital coaching for the duration of the study. Participants will complete weekly assessments regarding the program during their initial 12-week intervention phase. The primary outcome is the change from baseline to 12 weeks in the intervention group versus the control group, in the combined number of repetitions performed in one set of each of the three exercises (composite repetitions) under a standardized protocol. Secondary outcomes include adherence to and satisfaction with the program, and change from baseline to 12- and 24-week follow-up in blood pressure, fasting lipid panel, hemoglobin A1c, body mass index, anthropometry, body composition, mid-thigh muscle thickness, and habit strength.
DISCUSSION


This study will evaluate a simple, habit-based RT intervention in untrained individuals. The approach is unique in that it utilizes brief but frequent bodyweight exercises and, via the THM, focuses on consistency and habit formation first, with effort being increased as participants are motivated and able. If effective, the program can be easily scaled for wider adoption.
TRIAL REGISTRATION


This study was prospectively registered at ClinicalTrials.gov, identifier NCT04207567 , on December 23rd, 2019.",2020,"The primary outcome is the change from baseline to 12 weeks in the intervention group versus the control group, in the combined number of repetitions performed in one set of each of the three exercises (composite repetitions) under a standardized protocol.","['Forty-60 untrained osteopathic medical students and college/university employees who work in an office setting will be recruited and randomized (1:1) to an', 'untrained individuals']","['intervention or waitlist control group', 'habit-based, bodyweight resistance training program', 'habit-based RT intervention', 'training in the Tiny Habits® Method (THM) and digital coaching', 'Resistance-training (RT']","['adherence to and satisfaction with the program, and change from baseline to 12- and 24-week follow-up in blood pressure, fasting lipid panel, hemoglobin A1c, body mass index, anthropometry, body composition, mid-thigh muscle thickness, and habit strength']","[{'cui': 'C0419203', 'cui_str': 'Osteopathy'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0430044', 'cui_str': 'Fasting lipid profile'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0224416', 'cui_str': 'Skeletal muscle structure of thigh'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",,0.037425,"The primary outcome is the change from baseline to 12 weeks in the intervention group versus the control group, in the combined number of repetitions performed in one set of each of the three exercises (composite repetitions) under a standardized protocol.","[{'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Hollingsworth', 'Affiliation': 'Edward Via College of Osteopathic Medicine - Auburn Campus, 910 South Donahue Drive, Auburn, AL, 36832, USA. jhollingsworth@auburn.vcom.edu.'}, {'ForeName': 'Kaelin C', 'Initials': 'KC', 'LastName': 'Young', 'Affiliation': 'Edward Via College of Osteopathic Medicine - Auburn Campus, 910 South Donahue Drive, Auburn, AL, 36832, USA.'}, {'ForeName': 'Siraj F', 'Initials': 'SF', 'LastName': 'Abdullah', 'Affiliation': 'Edward Via College of Osteopathic Medicine - Auburn Campus, 910 South Donahue Drive, Auburn, AL, 36832, USA.'}, {'ForeName': 'Danielle D', 'Initials': 'DD', 'LastName': 'Wadsworth', 'Affiliation': 'Auburn University, School of Kinesiology, 301 Wire Road, Auburn, AL, 36849, USA.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Abukhader', 'Affiliation': 'Edward Via College of Osteopathic Medicine - Auburn Campus, 910 South Donahue Drive, Auburn, AL, 36832, USA.'}, {'ForeName': 'Bari', 'Initials': 'B', 'LastName': 'Elfenbein', 'Affiliation': 'Edward Via College of Osteopathic Medicine - Auburn Campus, 910 South Donahue Drive, Auburn, AL, 36832, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Holley', 'Affiliation': 'Edward Via College of Osteopathic Medicine - Auburn Campus, 910 South Donahue Drive, Auburn, AL, 36832, USA.'}]",BMC public health,['10.1186/s12889-020-09355-4']
1329,32777710,Community-level interventions for pre-eclampsia (CLIP) in Pakistan: A cluster randomised controlled trial.,"OBJECTIVES


To reduce all-cause maternal and perinatal mortality and major morbidity through Lady Health Worker (LHW)-facilitated community engagement and early diagnosis, stabilization and referral of women with preeclampsia, an important contributor to adverse maternal and perinatal outcomes given delays in early detection and initial management.
STUDY DESIGN


In the Pakistan Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomized controlled trial (NCT01911494), LHWs engaged the community, recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization.
MAIN OUTCOME MEASURES


The primary outcome was a composite of maternal, fetal and newborn mortality and major morbidity.
FINDINGS


We recruited 39,446 women in intervention (N = 20,264) and control clusters (N = 19,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively). The primary outcome did not differ between intervention (26·6%) and control (21·9%) clusters (adjusted odds ratio, aOR, 1∙20 [95% confidence interval 0∙84-1∙72]; p = 0∙31). There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77); early (0·95 [0·82-1·09]; p = 0·46) or late neonatal deaths (1·23 [0·97-1·55]; p = 0·09); or neonatal morbidity (1·22 [0·77, 1·96]; p = 0·40). Improvements in outcome rates were observed with 4-7 (p = 0·015) and ≥8 (p < 0·001) (vs. 0) CLIP contacts.
INTERPRETATION


The CLIP intervention was well accepted by the community and implemented by LHWs. Lack of effects on adverse outcomes could relate to quality care for mothers with pre-eclampsia in health facilities. Future strategies for community outreach must also be accompanied by health facility strengthening.
FUNDING


The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77);","['39,446 women in intervention (N\xa0=\xa020,264) and control clusters (N\xa0=\xa019,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively', 'mothers with pre-eclampsia in health facilities', 'recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization', 'pre-eclampsia (CLIP) in Pakistan', 'women with preeclampsia']","['Community-level interventions', 'CLIP intervention']","['late neonatal deaths', 'neonatal morbidity', 'outcome rates', 'maternal death', 'reduction in stillbirths', 'composite of maternal, fetal and newborn mortality and major morbidity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}]","[{'cui': 'C0455987', 'cui_str': 'Late neonatal death'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",39446.0,0.261501,"There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77);","[{'ForeName': 'Rahat N', 'Initials': 'RN', 'LastName': 'Qureshi', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Hoodbhoy', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan; Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto, ON M5G 2L3, Canada. Electronic address: zulfiqar.bhutta@aku.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'the CLIP Pakistan Trial Working Group (Table S1).'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.07.011']
1330,32777737,Evaluation of efficacy and safety of rituximab in combination with mycophenolate mofetil in patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD): A double-blind placebo-controlled randomized trial.,"INTRODUCTION


Nonspecific interstitial pneumonia (NSIP) are rare but severe diseases, with high mortality and morbidity, with no effective pharmacological treatment allowing for long-term remission, and therefore no clear therapeutic recommendations. Classic immunosuppressants are used as first-line treatment, with only one third of patients being responders and no clear recommendations exist for the choice of the second-line therapy. The EvER-ILD study is the first one to prospectively evaluate the efficacy and safety of rituximab and mycophenolate mofetil (MMF) versus placebo and MMF in a broad range of NSIP patients that did not respond to a first-line therapy. A pharmacokinetic-pharmacodynamic analysis based on rituximab serum concentrations will allow identification of potential factors associated with therapeutic response and/or adverse effects.
METHODS


EvER-ILD study is a French multicenter, prospective, randomized, double blind, placebo-controlled, superiority trial. Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment will be randomized in 2 groups of treatment: one course of rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group). The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months. Several clinical, biological, and quality of life secondary outcomes will be measured at 3, 6 and 12 months. A sample size of 122 patients (61 patients per group) would allow to show a point difference between groups in the change of FVC at 6 months, based on a common standard deviation for FVC change of 8% with a power of 90%, alpha 5% two-sided, and anticipating an extreme 10% drop-out rate.
ETHICS AND DISSEMINATION


The protocol was approved by the French Research Ethics Committee (CPP Tours Ouest 1 2016-R28) on November 10, 2016, and by the French competent authority (ANSM, reference 160771A-22) on December 1st, 2016. This article refers to protocol V2, dated November 18, 2016. An independent data safety monitoring board will review safety and tolerability data for the duration of the trial. Results will be disseminated via peer reviewed publication and presentation at international conferences.
TRIAL REGISTRATION NUMBER


NCT02990286 (clinicaltrials.gov), EudraCT 2016-003026-16 (European Medicines agency).",2020,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","['2016-003026-16 (European Medicines agency', '122 patients (61 patients per group', 'patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD', 'Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment']","['EudraCT', 'mycophenolate mofetil', 'rituximab and mycophenolate mofetil (MMF) versus placebo and MMF', 'rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group', 'rituximab', 'placebo']","['change in Forced Vital Capacity (FVC, % of predicted']","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1290344', 'cui_str': 'Nonspecific interstitial pneumonia'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0073081', 'cui_str': 'resiniferatoxin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]",,0.378227,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bejan-Angoulvant', 'Affiliation': 'Service de Pharmacologie médicale, CHRU de Tours, Hôpital Bretonneau, Université de Tours, Tours, France.'}, {'ForeName': 'J-Marc', 'Initials': 'JM', 'LastName': 'Naccache', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caille', 'Affiliation': 'Inserm CIC1415, CHRU Tours, Université de Tours, Université de Nantes, SPHERE, U1246, Tours, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Borie', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nunes', 'Affiliation': 'Service de pneumologie, centre constitutif pour les maladies pulmonaires rares, hôpital Avicenne, CHU Paris Seine-Saint-Denis, Bobigny, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ferreira', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cadranel', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Crestani', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'Service de Pneumologie, Centre national coordonnateur de référence des maladies pulmonaires rares, Hôpital Louis Pradel, Hospices civils de Lyon, UMR 754, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Marchand-Adam', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France. Electronic address: s.marchandadam@univ-tours.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiratory medicine and research,['10.1016/j.resmer.2020.100770']
1331,32772873,Intranasal Ketamine as an Adjunct to Fentanyl for the Prehospital Treatment of Acute Traumatic Pain: Design and Rationale of a Randomized Controlled Trial.,"OBJECTIVE


Acute pain management is fundamental in prehospital trauma care. Early pain control may decrease the risk of developing post-traumatic stress disorder (PTSD) and chronic pain. Fentanyl and ketamine are frequently used off-label, but there is a paucity of comparative data to guide decision-making about treatment of prehospital severe, acute pain. This trial will determine whether the addition of single dose of intranasal ketamine to fentanyl is more effective for the treatment of acute traumatic pain than administration of fentanyl alone.
METHODS


This two-part study consists of prehospital and 90-day follow-up components (NCT02866071). The prehospital trial is a blinded, randomized, controlled trial of adult men (age 18-65 years) rating pain ≥7/10 after an acute traumatic injury of any type. Women will be excluded due to inability to confirm pregnancy status and unknown fetal risk. Paramedics will screen patients receiving standard of care fentanyl and, after obtaining standard informed consent, administer 50 mg intranasal ketamine or matching volume saline as placebo. Upon emergency department (ED) arrival, research associates will serially assess pain, concomitant treatments, and adverse side effects. Enrolled subjects will be approached for consent to participate in the 90-day follow-up study to determine rates of PTSD and chronic pain development. The primary outcome of the prehospital study is reduction in pain on the Verbal Numerical Rating Scale between baseline and 30-minutes after study drug administration. The proportion achieving a reduction of ≥2-points will be compared between study arms using a Chi-square test. Secondary outcomes of the prehospital trial include reduction in reported pain at the time of ED arrival and at 30 minutes intervals for up to three hours of ED care, the incidence of adverse events, and additional opiate requirements prior to ED arrival and within the first three hours of ED care. The outcomes in the follow-up study are satisfaction with life and development of PTSD or chronic pain at 90 days after injury. An intention-to-treat approach will be used.
CONCLUSION


These studies will test the hypotheses that ketamine plus fentanyl, when compared to fentanyl alone, effectively manages pain, decreases opiate requirements, and decreases PTSD at 90 days.",2020,The outcomes in the follow-up study are satisfaction with life and development of PTSD or chronic pain at 90 days after injury.,"['adult men (age 18-65 years) rating pain ≥7/10 after an acute traumatic injury of any type', 'Acute Traumatic Pain']","['Fentanyl and ketamine', 'ketamine plus fentanyl', 'Fentanyl', 'Intranasal Ketamine', 'ketamine or matching volume saline as placebo', 'intranasal ketamine']","['acute traumatic pain', 'reported pain at the time of ED arrival and at 30\u2009minutes intervals for up to three hours of ED care, the incidence of adverse events, and additional opiate requirements prior to ED arrival and within the first three hours of ED care', 'satisfaction with life and development of PTSD or chronic pain', 'pain on the Verbal Numerical Rating Scale', 'risk of developing post-traumatic stress disorder (PTSD) and chronic pain', 'rates of PTSD and chronic pain development']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.232566,The outcomes in the follow-up study are satisfaction with life and development of PTSD or chronic pain at 90 days after injury.,"[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'McMullan', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Droege', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Strilka', 'Affiliation': ''}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Hart', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lindsell', 'Affiliation': ''}]",Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors,['10.1080/10903127.2020.1808746']
1332,32781283,Efficacy of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in treatment of COVID-19: A randomized controlled trial.,"BACKGROUND


With the global epidemic of coronavirus disease (COVID-19), China has made progress in the prevention and control of the epidemic, and traditional Chinese medicine (TCM) has played a key role in dealing with the disease's effects on the respiratory system. This randomized controlled clinical trial evaluated the clinical efficacy and prognosis of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in patients with COVID-19.
METHODS


A total of 283 patients participated in this clinical trial, and participants were randomly assigned to receive either 1) Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules or 2) Linahua granules, both combined with western medicine, or 3) western medicine alone for 14 days. At the end of the trial, the improvement and resolution rates of clinical symptoms and the rate of patients who progressed to severe disease status were evaluated.
RESULTS


After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05). Huoxiang Zhengqi dropping pills combined with Lianhua Qingwen granules has advantages in the treatment of nausea, vomiting and limb soreness. During treatment, all participants were treated with western medicine, and there was a significant difference in the use of macrolides among the three groups (P < 0.05). Specifically, the utilization rate of antibiotics in the western medicine group was significantly greater than that of the other two groups. Among the 182 diagnosed patients who completed this clinical trial, 13 patients progressed to severe disease, including one case in the Huoxiang + Lianhua group (1.6 %), five cases in the Lianhua group (8.6 %), and seven cases in the western medicine group (11.1 %). There was no statistical differences in this rate among the three groups (P >  0.05). However, the proportion of patients who progressed to severe disease in the Huoxiang + Lianhua group was the lowest, suggesting that the combination of TCM with western medicine has a potential advantage in improving the prognosis of patients with COVID-19.
CONCLUSION


The use of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine may have clinical advantages for COVID-19 patients in improving clinical symptoms, reducing utilization rate of anti-infective drugs, and improving patient prognosis, which could pave the way for the use of complementary medicine in treating this infection.",2020,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","['patients with COVID-19', 'COVID-19', '283 patients participated in this clinical trial, and participants', '182 diagnosed patients']","['Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules', 'Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine']","['utilization rate of antibiotics', 'improvement rate of clinical symptoms', 'nausea, vomiting and limb soreness', 'severe disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C1871293', 'cui_str': 'Huoxiang-zhengqi'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",283.0,0.0509695,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","[{'ForeName': 'Mingzhong', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: xmz0001@sohu.com.'}, {'ForeName': 'Jiaxing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tina_yai@126.com.""}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: nana680@sina.com.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 510247444@qq.com.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Min', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Mxj922@sohu.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 562163610@qq.com.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 719834165@qq.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 10029, China. Electronic address: novelzhang@sina.com.'}, {'ForeName': 'Dengying', 'Initials': 'D', 'LastName': 'Yan', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: yandengying@outlook.com.'}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Lang', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: suping.lang@gcp-clinplus.com.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: r.e.x@163.com.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Fan', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: an.fan@gcp-clinplus.com.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Ke', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 24929135@qq.com.'}, {'ForeName': 'Xiuyang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: leexiuyang@126.com.""}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 291560898@qq.com.'}, {'ForeName': 'Manhong', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 43166472@qq.com.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 48302079@qq.com.'}, {'ForeName': 'Jinyue', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 627525649@qq.com.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 491193488@qq.com.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 87068066@qq.com.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zeng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 309452513@qq.com.'}, {'ForeName': 'Chengyin', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 40691534@qq.com.'}, {'ForeName': 'Yujiao', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: luoyuorz@163.com.""}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: dr-whr@foxmail.com.""}, {'ForeName': 'Jiaran', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: 502230253@qq.com.""}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Lian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: lfm565@sohu.com.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Lixiaodong555@126.com.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tongxiaolin@vip.163.com.""}]",Pharmacological research,['10.1016/j.phrs.2020.105126']
1333,32781397,Parental sensitivity mediates the sustained effect of Attachment and Biobehavioral Catch-up on cortisol in middle childhood: A randomized clinical trial.,"IMPORTANCE


Parenting interventions have been found to normalize cortisol regulation among high-risk children early in development; it is important to investigate the sustainability of these effects and their mechanisms, given the maladaptive outcomes associated with cortisol dysregulation.
OBJECTIVE


To determine whether the Attachment and Biobehavioral Catch-up (ABC) intervention, implemented in infancy, predicts cortisol regulation in middle childhood via changes in early parental sensitivity.
DESIGN


Double blind randomized clinical trial design; started January 2006, the follow-up for this project concluded March 2016.
SETTING


Parents of children under age 2 referred from child protective services agencies in a large, mid-Atlantic city.
PARTICIPANTS


103 parent-child dyads (45.6% female children) with histories of child protective services involvement, randomly assigned to receive ABC (n = 45) or a control intervention (n = 58); in infancy, the children's ages ranged from 1.60 to 25.30 months (M = 9.87 months); at the middle childhood follow-up, they ranged from 8.0 to 11.0 years old (M = 8.52 years).
INTERVENTIONS


Both conditions included 10-week, in-home, manualized interventions. The experimental condition, ABC, has 3 primary targets for parents: increasing nurturance to child distress, increasing following the child's lead, and decreasing frightening behavior. The control intervention, Developmental Education for Families (DEF), is an adaptation of a program focused on enhancing cognitive and language development.
MAIN OUTCOMES AND MEASURES


Parental sensitivity was coded from a semi-structured interaction task between the parent and child in early childhood. Middle childhood diurnal cortisol slopes were modeled by collecting salivary cortisol samples from children at wake-up and bedtime over the course of 3 consecutive days.
RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002. The indirect effect of ABC on cortisol regulation via sensitivity was significant, β = -0.15, p = .038.
CONCLUSIONS AND RELEVANCE


ABC has an indirect effect on middle childhood diurnal cortisol regulation via parental sensitivity; future research should seek to determine how this enhanced neurobiological regulation relates to children's behavioral, socioemotional, and psychological outcomes.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT02093052.",2020,"RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002.","['Parents of children under age 2 referred from child protective services agencies in a large, mid-Atlantic city', ""n = 58); in infancy, the children's ages ranged from 1.60 to 25.30 months (M = 9.87 months); at the middle childhood follow-up, they ranged from 8.0 to 11.0 years old (M = 8.52 years"", 'middle childhood', '103 parent-child dyads (45.6% female children) with histories of child protective services involvement']","['control intervention, Developmental Education for Families (DEF', 'Attachment and Biobehavioral Catch-up (ABC) intervention', 'ABC', 'control intervention']","['Middle childhood diurnal cortisol slopes', 'cortisol regulation via sensitivity']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0231617', 'cui_str': 'Catch'}]","[{'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0395333,"RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002.","[{'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Garnett', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States. Electronic address: mgarnett@udel.edu.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Bernard', 'Affiliation': 'Stony Brook University, Psychology B Building, Stony Brook, NY, 11794, United States.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hoye', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Zajac', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104809']
1334,32784446,Influence of a Six-Week Swimming Training with Added Respiratory Dead Space on Respiratory Muscle Strength and Pulmonary Function in Recreational Swimmers.,"The avoidance of respiratory muscle fatigue and its repercussions may play an important role in swimmers' health and physical performance. Thus, the aim of this study was to investigate whether a six-week moderate-intensity swimming intervention with added respiratory dead space (ARDS) resulted in any differences in respiratory muscle variables and pulmonary function in recreational swimmers. A sample of 22 individuals (recreational swimmers) were divided into an experimental (E) and a control (C) group, observed for maximal oxygen uptake (VO 2 max). The intervention involved 50 min of front crawl swimming performed at 60% VO 2 max twice weekly for six weeks. Added respiratory dead space was induced via tube breathing (1000 mL) in group E during each intervention session. Respiratory muscle strength variables and pulmonary and respiratory variables were measured before and after the intervention. The training did not increase the inspiratory or expiratory muscle strength or improve spirometric parameters in any group. Only in group E, maximal tidal volume increased by 6.3% ( p  = 0.01). The ARDS volume of 1000 mL with the diameter of 2.5 cm applied in moderate-intensity swimming training constituted too weak a stimulus to develop respiratory muscles and lung function measured in the spirometry test.",2020,"Only in group E, maximal tidal volume increased by 6.3% ( p  = 0.01).","['Recreational Swimmers', '22 individuals (recreational swimmers', 'recreational swimmers']","['Six-Week Swimming Training with Added Respiratory Dead Space', 'six-week moderate-intensity swimming intervention with added respiratory dead space (ARDS']","['inspiratory or expiratory muscle strength or improve spirometric parameters', 'Respiratory muscle strength variables and pulmonary and respiratory variables', 'Respiratory Muscle Strength and Pulmonary Function', 'maximal tidal volume']","[{'cui': 'C0450068', 'cui_str': 'Swimmer'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0035218', 'cui_str': 'Respiratory dead space'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}]",,0.0169109,"Only in group E, maximal tidal volume increased by 6.3% ( p  = 0.01).","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Szczepan', 'Affiliation': 'Department of Swimming, Faculty of Physical Education, University School of Physical Education in Wroclaw, Ignacego Jana Paderewskiego 35, Swimming Pool, 51-612 Wroclaw, Poland.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Danek', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Physical Education, University School of Physical Education in Wroclaw, Ignacego Jana Paderewskiego 35, P-3 Building, 51-612 Wroclaw, Poland.'}, {'ForeName': 'Kamil', 'Initials': 'K', 'LastName': 'Michalik', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Physical Education, University School of Physical Education in Wroclaw, Ignacego Jana Paderewskiego 35, P-3 Building, 51-612 Wroclaw, Poland.'}, {'ForeName': 'Zofia', 'Initials': 'Z', 'LastName': 'Wróblewska', 'Affiliation': 'Faculty of Pure and Applied Mathematics, Wroclaw University of Science and Technology, Zygmunta Janiszewskiego 14a, C-11 Building, 50-372 Wroclaw, Poland.'}, {'ForeName': 'Krystyna', 'Initials': 'K', 'LastName': 'Zatoń', 'Affiliation': 'Department of Swimming, Faculty of Physical Education, University School of Physical Education in Wroclaw, Ignacego Jana Paderewskiego 35, Swimming Pool, 51-612 Wroclaw, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17165743']
1335,32784613,"""Moving Forward with Life"": Acceptability of a Brief Alcohol Reduction Intervention for People Receiving Antiretroviral Therapy in South Africa.","BACKGROUND


In South Africa, interventions are needed to address the impact of hazardous drinking on antiretroviral therapy among people living with HIV (PLWH). Participant feedback about these interventions can identify ways to enhance their acceptability. We interviewed participants in a randomized controlled trial of a brief motivational interviewing and problem-solving therapy (MI-PST) intervention about their perceptions of this alcohol-reduction intervention.
METHODS


The trial was conducted in HIV treatment clinics operating from six hospitals in the Tshwane region of South Africa. We conducted qualitative in-depth interviews with a random selection of participants. Twenty-four participants were interviewed after the final intervention session and 25 at the six-month follow up.
RESULTS


Participants believed that it was acceptable to offer PLWH, an alcohol reduction intervention during HIV treatment. They described how the MI-PST intervention had helped them reduce their alcohol consumption. Intervention components providing information on the health benefits of reduced consumption and building problem-solving and coping skills were perceived as most beneficial. Despite these perceived benefits, participants suggested minor modifications to the dosage, content, and delivery of the intervention for greater acceptability and impact.
CONCLUSIONS


Findings highlight the acceptability and usefulness of this MI-PST intervention for facilitating reductions in alcohol consumption among PLWH.",2020,Intervention components providing information on the health benefits of reduced consumption and building problem-solving and coping skills were perceived as most beneficial.,"['People Receiving Antiretroviral Therapy in South Africa', 'people living with HIV (PLWH', 'HIV treatment clinics operating from six hospitals in the Tshwane region of South Africa']","['brief motivational interviewing and problem-solving therapy (MI-PST) intervention', 'alcohol-reduction intervention', 'MI-PST intervention', 'Alcohol Reduction Intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454727', 'cui_str': 'Region of South Africa'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",[],24.0,0.0743292,Intervention components providing information on the health benefits of reduced consumption and building problem-solving and coping skills were perceived as most beneficial.,"[{'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Myers', 'Affiliation': 'Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Tygerberg 7505, South Africa.'}, {'ForeName': 'Charles D H', 'Initials': 'CDH', 'LastName': 'Parry', 'Affiliation': 'Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Tygerberg 7505, South Africa.'}, {'ForeName': 'Neo K', 'Initials': 'NK', 'LastName': 'Morojele', 'Affiliation': 'Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Tygerberg 7505, South Africa.'}, {'ForeName': 'Sebenzile', 'Initials': 'S', 'LastName': 'Nkosi', 'Affiliation': 'Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Tygerberg 7505, South Africa.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Shuper', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, ON M5T1R8, Canada.'}, {'ForeName': 'Connie T', 'Initials': 'CT', 'LastName': 'Kekwaletswe', 'Affiliation': 'Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Tygerberg 7505, South Africa.'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Sorsdahl', 'Affiliation': 'Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry & Mental Health, University of Cape Town, Cape Town 7701, South Africa.'}]",International journal of environmental research and public health,['10.3390/ijerph17165706']
1336,32787371,The application of thromboelastography in risk stratification for selective thromboembolism prophylaxis after total joint arthroplasty in Chinese: a randomized controlled trial.,"BACKGROUND


As Asian populations, Chinese have a lower rate of high-risk gene mutations in venous thrombosis. Therefore, individual patient risk assessment, rather than a ""blanket policy"", is considered the best thromboembolism prophylaxis for Chinese. The purpose of this study was to evaluate the effectiveness and safety of selective thromboembolism prophylaxis compared with conventional thromboembolism prophylaxis by risk stratification with thromboelastography (TEG) after joint arthroplasty in Chinese.
METHODS


Between August 2016 to August 2017, Chinese patients who underwent hip or knee arthroplasty were randomly divided into a selective anticoagulation group (SAG) and a conventional anticoagulation group (CAG). Participants and outcome assessors were blinded. In the SAG, an anticoagulant was used when TEG indicated hypercoagulability; while in the CAG, an anticoagulant was regularly used until one month after surgery. Outcome evaluation included effectiveness (defined as the incidence of VTE), and safety (defined as the incidence of bleeding events, poor wound healing, blood loss, and infection).
RESULTS


A total of 197 patients (79 in the SAG and 118 in the CAG) were included in the study. There was 1 case of deep vein thrombosis (DVT) in the SAG and 2 cases of DVT in the CAG, but there was no significant difference between the two groups. Hidden blood loss in the SAG was 707.4±539.8 mL and hidden blood loss in the CAG was 617±565.0 mL, respectively (P>0.05). No significant difference was observed in perioperative blood loss between the SAG and the CAG (1,024.9±597.9 and 1,139.3±620.9 mL, respectively). Volume of blood transfusion was 92.4±270.2 mL in the SAG and 224.6±416.3 mL in the CAG, respectively, while rate of transfusion was 13.9% in the SAG and 33.9% in the CAG, respectively, which were significantly different between the two groups (P<0.05).
CONCLUSIONS


In Chinese patients who underwent hip or knee arthroplasty, the efficacy of selective anticoagulation using TEG in risk stratification was comparable to that of conventional anticoagulation. Furthermore, the safety of selective anticoagulant prophylaxis was superior to that of conventional anticoagulant prophylaxis.",2020,"In Chinese patients who underwent hip or knee arthroplasty, the efficacy of selective anticoagulation using TEG in risk stratification was comparable to that of conventional anticoagulation.","['197 patients (79 in the SAG and 118 in the CAG) were included in the study', 'selective thromboembolism prophylaxis after total joint arthroplasty in Chinese', 'Between August 2016 to August 2017, Chinese patients who underwent hip or knee arthroplasty', 'Chinese patients who underwent hip or knee arthroplasty', 'joint arthroplasty in Chinese']","['thromboelastography (TEG', 'selective thromboembolism prophylaxis', 'conventional thromboembolism prophylaxis', 'selective anticoagulation group (SAG) and a conventional anticoagulation group (CAG', 'thromboelastography']","['deep vein thrombosis (DVT', 'Hidden blood loss', 'effectiveness and safety', 'rate of transfusion', 'Volume of blood transfusion', 'hypercoagulability', 'perioperative blood loss', 'effectiveness (defined as the incidence of VTE), and safety (defined as the incidence of bleeding events, poor wound healing, blood loss, and infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199242', 'cui_str': 'Anticoagulant prophylaxis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0199242', 'cui_str': 'Anticoagulant prophylaxis'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0205262', 'cui_str': 'Occult'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0398623', 'cui_str': 'Thrombophilia'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",197.0,0.0498045,"In Chinese patients who underwent hip or knee arthroplasty, the efficacy of selective anticoagulation using TEG in risk stratification was comparable to that of conventional anticoagulation.","[{'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopedics, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China; Centre for Orthopaedic Translational Research, Medical School, University of Western Australia, Nedlands, Australia.""}, {'ForeName': 'Yuanchen', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Department of Orthopedics, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Qingtian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Orthopedics, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Zhantao', 'Initials': 'Z', 'LastName': 'Deng', 'Affiliation': ""Department of Orthopedics, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China. dengzhantao_med@163.com.""}, {'ForeName': 'Qiujian', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': ""Department of Orthopedics, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China. ZQJzqj666@yeah.net.""}]",Annals of palliative medicine,['10.21037/apm-19-385']
1337,32790451,Mobile enhancement of motivation in schizophrenia: A pilot randomized controlled trial of a personalized text message intervention for motivation deficits.,"OBJECTIVE


Motivation deficits remain an unmet treatment need in schizophrenia. Recent research has identified mechanisms underlying motivation deficits (i.e., impaired effort-cost computations, reduced future reward-value representation maintenance) that may be effective treatment targets to improve motivation. This study tested the feasibility and preliminary effectiveness of Mobile Enhancement of Motivation in Schizophrenia (MEMS), an intervention that leverages mobile technology to target these mechanisms with text messages.
METHOD


Fifty-six participants with a schizophrenia-spectrum disorder were randomized to MEMS (n = 27) or a control condition (n = 29). All participants set recovery goals to complete over 8 weeks. Participants in the MEMS group additionally received personalized, interactive text messages on their personal cellphones each weekday.
RESULTS


Retention and engagement in MEMS were high: 92.6% completed 8 weeks of MEMS, with an 86.1% text message response rate, and 100% reported being satisfied with the text messages. Compared to participants in the control condition, the participants in the MEMS condition had significantly greater improvements in interviewer-rated motivation and anticipatory pleasure and attained significantly more recovery-oriented goals at 8 weeks. There were no significant group differences in purported mechanisms (performance-based effort-cost computations and future reward-value representations) or in self-reported motivation, quality of life, or functioning.
CONCLUSION


Results demonstrate that MEMS is feasible as a brief, low-intensity mobile intervention that could effectively improve some aspects of motivation (i.e., initiation and maintenance of goal-directed behaviors) and recovery goal attainment for those with schizophrenia-spectrum disorders. More work is needed with larger samples and to understand the mechanisms of change in MEMS. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Compared to participants in the control condition, the participants in the MEMS condition had significantly greater improvements in interviewer-rated motivation and anticipatory pleasure and attained significantly more recovery-oriented goals at 8 weeks.","['schizophrenia', 'Fifty-six participants with a schizophrenia-spectrum disorder']","['Mobile Enhancement of Motivation in Schizophrenia (MEMS', 'personalized text message intervention', 'MEMS', 'personalized, interactive text messages on their personal cellphones each weekday', 'control condition']","['Retention and engagement in MEMS', 'interviewer-rated motivation and anticipatory pleasure', 'purported mechanisms (performance-based effort-cost computations and future reward-value representations) or in self-reported motivation, quality of life, or functioning']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1136359', 'cui_str': 'Cellular Phone'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0021821', 'cui_str': 'Interviewers'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",56.0,0.174855,"Compared to participants in the control condition, the participants in the MEMS condition had significantly greater improvements in interviewer-rated motivation and anticipatory pleasure and attained significantly more recovery-oriented goals at 8 weeks.","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Luther', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital.'}, {'ForeName': 'Melanie W', 'Initials': 'MW', 'LastName': 'Fischer', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Annalee V', 'Initials': 'AV', 'LastName': 'Johnson-Kwochka', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Kyle S', 'Initials': 'KS', 'LastName': 'Minor', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Holden', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine.'}, {'ForeName': 'Chris L', 'Initials': 'CL', 'LastName': 'Lapish', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'McCormick', 'Affiliation': 'Department of Health and Rehabilitation Sciences in the College of Public Health, Temple University.'}, {'ForeName': 'Michelle P', 'Initials': 'MP', 'LastName': 'Salyers', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000599']
1338,32790453,Internet-based self-help for psychosis: Findings from a randomized controlled trial.,"OBJECTIVE


Cognitive-behavioral therapy (CBT) for psychosis is recommended in many national guidelines, but dissemination into routine health care remains poor. This study tests whether an 8-week, CBT-oriented, Internet-based intervention (IBI) for people with psychosis is feasible, effective, and safe compared to care as usual.
METHOD


A sample of 101 people diagnosed with schizophrenia-spectrum disorders (age: M = 40.0, SD = 9.60; sex: 58% female) was randomly assigned to either an IBI for psychosis or a wait-list control condition. The primary outcome was a composite score of the positive factor of the Positive and Negative Syndrome Scale, the Launay Slade Hallucination Scale, and the paranoia checklist (clinicaltrials.gov, NCT02974400).
RESULTS


The composite score of psychotic symptom severity decreased more in the IBI condition than in the wait-list condition, reflected in the significant interaction of Time × Condition, F(1, 87.28) = 4.04, p = .047, dbetween = 0.24, 95% CI [-0.15, 0.63]. In the combined sample of participants who received immediate or delayed access to the intervention, the outcome improved further during the 6-month follow up period with a significant main effect of time, F(1, 69.35) = 9.59, p = .003, d = -0.37, 95% CI [-0.66, -0.07]. Participants were satisfied with the intervention (89%), and many used the intervention as defined per protocol (52%; at least four completed modules). Adverse events were infrequent (4.9%).
CONCLUSIONS


Internet-based, CBT-oriented interventions provide an add-on effect to care as usual and have the potential to narrow the psychological treatment gap in psychosis. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"The composite score of psychotic symptom severity decreased more in the IBI condition than in the wait-list condition, reflected in the significant interaction of Time × Condition, F(1, 87.28) =","['people with psychosis', '101 people diagnosed with schizophrenia-spectrum disorders (age: M = 40.0, SD = 9.60; sex: 58% female']","['IBI for psychosis or a wait-list control condition', 'CBT-oriented, Internet-based intervention (IBI', 'Cognitive-behavioral therapy (CBT']","['composite score of psychotic symptom severity', 'Adverse events', 'composite score of the positive factor of the Positive and Negative Syndrome Scale, the Launay Slade Hallucination Scale, and the paranoia checklist (clinicaltrials.gov, NCT02974400']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",101.0,0.101073,"The composite score of psychotic symptom severity decreased more in the IBI condition than in the wait-list condition, reflected in the significant interaction of Time × Condition, F(1, 87.28) =","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Westermann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Rüegg', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern.'}, {'ForeName': 'Thies', 'Initials': 'T', 'LastName': 'Lüdtke', 'Affiliation': 'Department of Psychology, UiT-The Arctic University of Norway.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000602']
1339,32790492,PARP Inhibitors in the Management of Ovarian Cancer: ASCO Guideline.,"PURPOSE


To provide recommendations on the use of poly(ADP-ribose) polymerase inhibitors (PARPis) for management of epithelial ovarian, tubal, or primary peritoneal cancer (EOC).
METHODS


Randomized, controlled, and open-labeled trials published from 2011 through 2020 were identified in a literature search. Guideline recommendations were based on the review of the evidence, US Food and Drug Administration approvals, and consensus when evidence was lacking.
RESULTS


The systematic review identified 17 eligible trials.
RECOMMENDATIONS


The guideline pertains to patients who are PARPi naïve. All patients with newly diagnosed, stage III-IV EOC whose disease is in complete or partial response to first-line, platinum-based chemotherapy with high-grade serous or endometrioid EOC should be offered PARPi maintenance therapy with niraparib. For patients with germline or somatic pathogenic or likely pathogenic variants in  BRCA1  (g/s BRCA 1) or  BRCA2  (g/s BRCA 2) genes should be treated with olaparib. The addition of olaparib to bevacizumab may be offered to patients with stage III-IV EOC with g/s BRCA1/ 2 and/or genomic instability and a partial or complete response to chemotherapy plus bevacizumab combination. Maintenance therapy (second line or more) with single-agent PARPi may be offered for patients with EOC who have not received a PARPi and have responded to platinum-based therapy regardless of  BRCA  mutation status. Treatment with a PARPi should be offered to patients with recurrent EOC that has not recurred within 6 months of platinum-based therapy, who have not received a PARPi and have a g/s BRCA1/2 , or whose tumor demonstrates genomic instability. PARPis are not recommended for use in combination with chemotherapy, other targeted agents, or immune-oncology agents in the recurrent setting outside the context of a clinical trial. Recommendations for managing specific adverse events are presented. Data to support reuse of PARPis in any setting are needed.Additional information is available at www.asco.org/gynecologic-cancer-guidelines.",2020,(g/s BRCA 1) or  BRCA2  ,"['patients with EOC who have not received a PARPi and have responded to platinum-based therapy regardless of  BRCA  mutation status', 'patients with germline or somatic pathogenic or likely pathogenic variants in  BRCA1', 'All patients with newly diagnosed, stage III-IV EOC whose disease is in complete or partial response to first-line, platinum-based chemotherapy with high-grade serous or endometrioid EOC']","['Maintenance therapy (second line or more) with single-agent PARPi', 'PARP Inhibitors', 'PARPi', 'poly(ADP-ribose) polymerase inhibitors (PARPis', 'bevacizumab']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0440743', 'cui_str': 'Serous'}]","[{'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]",[],,0.0750957,(g/s BRCA 1) or  BRCA2  ,"[{'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Tew', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lacchetti', 'Affiliation': 'American Society of Clinical Oncology, Alexandria, VA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Ellis', 'Affiliation': 'SHARE Cancer Support, New York, NY.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Maxian', 'Affiliation': 'Ovarian Cancer Project, Williamsville, NY.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bookman', 'Affiliation': 'Kaiser Permanente, San Francisco, CA.'}, {'ForeName': 'Monica Brown', 'Initials': 'MB', 'LastName': 'Jones', 'Affiliation': 'DeCesaris Cancer Institute, Anne Arundel Medical Center, Annapolis, MD.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Lheureux', 'Affiliation': 'University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Joyce F', 'Initials': 'JF', 'LastName': 'Liu', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Kathleen N', 'Initials': 'KN', 'LastName': 'Moore', 'Affiliation': 'Stephenson Cancer Center, Oklahoma City, OK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Muller', 'Affiliation': 'University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Rodriguez', 'Affiliation': 'Virginia Cancer Specialists, Arlington, VA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Walsh', 'Affiliation': 'Cedars-Sinai, West Hollywood, CA.'}, {'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Westin', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Elise C', 'Initials': 'EC', 'LastName': 'Kohn', 'Affiliation': 'National Cancer Institute, Bethesda, MD.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01924']
1340,32797070,Learning new sport actions: Pilot study to investigate the imitative and the verbal instructive teaching methods in motor education.,"The aim of the project was to investigate the effects of two strategies of teaching new sport actions on performance of eight-year-old children: observational-imitative method (OIM) and descriptive-directive method (DDM). The OIM group was provided with a pre-practice instruction in the form of expert modeling observation by an expert athlete. The DDM group received only verbal explanations of few selected static images. Thirty-six children (18 males and 18 females, mean age = 8,8) participated in the experiment. Subjects were randomly assigned to the OIM or DDM groups. Participants were instructed to perform four sport motor sequences never performed before (shoulder stand, soccer action, vortex howler throw, step action). Actions were videotaped and 2D kinematic analysis performed. A 10-point Likert questionnaire was administered to blind sport experts to assess the correctness and accuracy of each action. Results suggest that the OIM is the most effective instruction method when participants have no experience with the sport action to be performed. On the contrary, if the athlete needs to learn specific aspects of an exercise (such as grasping a tool) the best method is the DDM. In fact, detailed information on how to grab the vortex helped children in throwing it. We also found gender differences which might reflect cultural influences in specific sports (e.g. soccer). Finally, repetition of the exercise also improved the DDM group's performance. This has potential applications in sport teaching, suggesting that in the absence of a model performing the action to be imitated, the DDM can be as effective as the OIM if the observer repeats the sport action many times.",2020,Results suggest that the OIM is the most effective instruction method when participants have no experience with the sport action to be performed.,"['eight-year-old children', 'Thirty-six children (18 males and 18 females, mean age = 8,8) participated in the experiment']","['teaching new sport actions', 'OIM or DDM']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",[],36.0,0.0155288,Results suggest that the OIM is the most effective instruction method when participants have no experience with the sport action to be performed.,"[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'De Stefani', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Rodà', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Elio', 'Initials': 'E', 'LastName': 'Volta', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Pincolini', 'Affiliation': 'Giocampus Steering Committee, Parma, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Farnese', 'Affiliation': 'Giocampus Steering Committee, Parma, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Rossetti', 'Affiliation': 'Giocampus Steering Committee, Parma, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Pedretti', 'Affiliation': 'Giocampus Steering Committee, Parma, Italy.'}, {'ForeName': 'Pier Francesco', 'Initials': 'PF', 'LastName': 'Ferrari', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}]",PloS one,['10.1371/journal.pone.0237697']
1341,32777605,"The psychological impact of a nurse-led proactive self-care program on independent, non-frail community-dwelling older adults: A randomized controlled trial.","BACKGROUND


Poor mental health is common later in life and is a crucial factor in determining older adults' ability to live independently in the community. Existing nurse-led proactive self-care programs for older adults focus on physical health, since many are living with chronic diseases. Little is known about their effectiveness on the psychological outcomes of independent, non-frail community-dwelling older adults.
AIM


The aim of this study was to examine the impact of a nurse-led proactive self-care program with a health-social partnership model for community-dwelling older adults on depressive symptoms, life satisfaction, and the mental component of health-related quality of life.
DESIGN AND METHODS


This was a single-blinded, randomized controlled trial. Adults aged 60 or over who lived within the service areas and scored ≥ 18 in the Mini-Mental Status Examination were included. Data were collected using questionnaires pre- (T1), post- (T2), and three month after the intervention (T3). The program provided a comprehensive assessment, health and self-management information, and empowerment, and promoted the accessibility of community services by building a health-social partnership network in the community. Generalized Estimating Equation was used to calculate the group, time, and interaction effects. Intention-to-treat was employed as the primary analysis in this study.
RESULTS


Of the 843 potential community-dwelling older adults who were assessed for eligibility, 457 eligible participants were randomized into the intervention (n = 230) or control group (n = 227). Among them, 175 (76.0%) participants in the intervention group and 190 (83.7%) participants in the control group completed data collection at T3, 6 months after T2 at the completion of the program. The results showed a significant time effect between T1 and T2 (Wald χ2 = 25.7, p < .001) and T1 and T3 (Wald χ2 = 7.40, p = .007) in terms of the presence of depressive symptoms.
CONCLUSIONS


Interprofessional care addressing health and social needs improves the depressive symptoms among older adults dwelling in the community.",2020,"The results showed a significant time effect between T1 and T2 (Wald χ2 = 25.7, p < .001) and T1 and T3 (","['older adults', 'non-frail community-dwelling older adults', 'older adults dwelling in the community', 'community-dwelling older adults', 'frail community-dwelling older adults', '457 eligible participants', 'Adults aged 60 or over who lived within the service areas and scored ≥ 18 in the Mini-Mental Status Examination were included', '843 potential community-dwelling older adults who were assessed for eligibility']","['Existing nurse-led proactive self-care programs', 'nurse-led proactive self-care program', 'nurse-led proactive self-care program with a health-social partnership model']","['depressive symptoms, life satisfaction, and the mental component of health-related quality of life', 'depressive symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",457.0,0.0758161,"The results showed a significant time effect between T1 and T2 (Wald χ2 = 25.7, p < .001) and T1 and T3 (","[{'ForeName': 'Arkers Kwan Ching', 'Initials': 'AKC', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong. Electronic address: Arkers.wong@polyu.edu.hk.'}, {'ForeName': 'Frances Kam Yuet', 'Initials': 'FKY', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong. Electronic address: Frances.wong@polyu.edu.hk.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103724']
1342,32777664,Digital application developed to evaluate functional results following robot-assisted radical prostatectomy: App for prostate cancer.,"INTRODUCTION


Mobile applications (""apps"") developed for smartphones and tablets are increasingly used in healthcare, allowing remote patient support or promoting self-health care. Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy. The main complications following surgery are urinary incontinence and erectile dysfunction. However, the exact numbers related to these morbidities are often missing due to brief interviews during consultations in the medical office. Therefore, the aim of this study was to create an app to determine whether response rates to pre- and post-surgical PC questionnaires will increase.
METHODS


The app was built using the IONIC framework system and provided to patients through a prospective randomized study. We included 100 patients divided into two groups: 1. first group used the app (n = 50); and 2. second group responded via validated printed questionnaires (control group) (n = 50). All patients received discharge counseling to respond to the questionnaires 1, 3, 6 and 12 months after the procedure. The app group received verbal guidance on how monitoring would occur, received an SMS containing a username and password providing access to the system and received reminder alerts to respond to the questionnaires.
RESULTS


The new app is called UroHealth and is available for download in the Apple App Store or at www.urohealth.com.br. When we evaluated the response rates, we found that 42.9% of the patients answered the preoperative questionnaire in the app group, while 16% responded in the control group (p = 0.003). By the end of the follow-up, we found that 24.5% of the patients answered the questionnaire in the app group, while 4% responded in the control group (p = 0.003).
CONCLUSION


This app enabled almost 6 times more patients to answer long-term follow-up questions after surgical procedures, providing high-quality information regarding morbidity related to treatment. Although our initial results indicate that this app may become a useful tool in obtaining more frequent and realistic answers, thus helping to improve surgical techniques, other ways of reaching the patient should be tested to achieve higher response rates.",2020,"Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy.",['100 patients divided into two groups: 1. first group used the app (n\xa0=\xa050); and'],"['robot-assisted radical prostatectomy', 'SMS containing a username and password providing access to the system and received reminder alerts to respond to the questionnaires', 'verbal guidance', '2. second group responded via validated printed questionnaires (control group', 'discharge counseling']","['response rates', 'preoperative questionnaire', 'urinary incontinence and erectile dysfunction']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}]",100.0,0.0209113,"Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy.","[{'ForeName': 'Leandro F', 'Initials': 'LF', 'LastName': 'Faria', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: lfaria83@gmail.com.'}, {'ForeName': 'Sabrina T', 'Initials': 'ST', 'LastName': 'Reis', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil; Faculdade Atenas - Campus Passos, Minas Gerais, 37900-380, Brazil. Electronic address: sasareis@gmail.com.'}, {'ForeName': 'Katia R', 'Initials': 'KR', 'LastName': 'Leite', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: katiaramos@usp.br.'}, {'ForeName': 'José Arnaldo Shiomi', 'Initials': 'JAS', 'LastName': 'da Cruz', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: arnadolshiomi@yahoo.com.br.'}, {'ForeName': 'Ruan', 'Initials': 'R', 'LastName': 'Pimenta', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: ruanpimenta22@gmail.com.'}, {'ForeName': 'Nayara I', 'Initials': 'NI', 'LastName': 'Viana', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: nayara_viana_2@hotmail.com.'}, {'ForeName': 'Gabriela Q', 'Initials': 'GQ', 'LastName': 'Amaral', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: gabriela.queiroz.amaral@gmail.com.'}, {'ForeName': 'Gabriel A G D', 'Initials': 'GAGD', 'LastName': 'Santos', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: arantes_gabriel@hotmail.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ilias', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: daniel.ilias22@gmail.com.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fakhouri', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: ffakhouri@gmail.com.'}, {'ForeName': 'Geraldo', 'Initials': 'G', 'LastName': 'Xavier', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: geraldoxaviermed@gmail.com.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Srougi', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: srougi@uol.com.br.'}, {'ForeName': 'Carlo Camargo', 'Initials': 'CC', 'LastName': 'Passerotti', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil; Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: carlopasserotti@hotmail.com.'}]",Computer methods and programs in biomedicine,['10.1016/j.cmpb.2020.105683']
1343,32773608,Femtosecond laser-assisted cataract surgery compared with phacoemulsification cataract surgery: randomized noninferiority trial with 1-year outcomes.,"PURPOSE


To report the 1-year outcomes of a randomized trial comparing femtosecond laser-assisted cataract surgery (FLACS) and phacoemulsification cataract surgery (PCS).
SETTING


Moorfields Eye Hospital, New Cross Hospital, and Sussex Eye Hospital, United Kingdom.
DESIGN


Multicenter, randomized controlled noninferiority trial.
METHODS


Patients undergoing cataract surgery were randomized to FLACS or PCS. Postoperative assessments were masked. Outcomes included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), complications, corneal endothelial cell count, and patient-reported outcomes measures.
RESULTS


The study enrolled 785 participants. A total of 311 of 392 (79%) participants were allocated to FLACS and 292 of 393 (74%) participants were allocated to PCS attended follow-up at 1 year. Mean UDVA was 0.14 (SD = 0.22) for FLACS and 0.17 (0.25) for PCS with difference of -0.03 logarithm of the minimum angle of resolution (logMAR) (95%, -0.06 to 0.01, P = .17). Mean CDVA was 0.003 (0.18) for FLACS and 0.03 (0.23) for PCS with difference of -0.03 logMAR (95% CI, -0.06 to 0.01, P = .11); 75% of both FLACS (230/307) and PCS (218/290) cases were within ±0.5 diopters (D) refractive target, and 292 (95%) of 307 eyes of FLACS and 279 (96%) of 290 eyes of PCS groups were within ±1.0 D. There were no significant differences between arms for all other outcomes with the exception of binocular CDVA mean difference -0.02 (-0.05 to 0.002) logMAR (P = .036) favoring FLACS. Mean cost difference was £167.62 per patient greater for FLACS (95% iterations between -£14.12 and £341.67).
CONCLUSIONS


PCS is not inferior to FLACS regarding vision, patient-reported health, and safety outcomes after 1-year follow-up. A difference was found for binocular CDVA, which, although statistically significant, was not clinically important. FLACS was not cost-effective.",2020,There were no significant differences between arms for all other outcomes with the exception of binocular CDVA mean difference -0.02 (-0.05 to 0.002) logMAR,"['Moorfields Eye Hospital, New Cross Hospital and Sussex Eye Hospital, UK DESIGN', '311 of 392 (79']","['phacoemulsification cataract surgery (FACT', 'femtosecond laser assisted cataract surgery (FLACS) and phacoemulsification cataract surgery (PCS', 'logMAR', 'FLACS', 'Femtosecond laser-assisted cataract surgery']","['mean cost difference', 'UDVA, CDVA, complications, corneal endothelial cell count and patient reported outcomes measures', 'Mean CDVA', 'Mean UDVA', 'binocular CDVA']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}]",,0.253575,There were no significant differences between arms for all other outcomes with the exception of binocular CDVA mean difference -0.02 (-0.05 to 0.002) logMAR,"[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Day', 'Affiliation': ""From the NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust (Day, Wilkins), London, Moorfields Eye Hospital (Day, Wilkins), London, UCL Institute of Ophthalmology (Day), London, School of Medicine, University of St. Andrews (Burr), St. Andrews, UCL Comprehensive Clinical Trials Unit (Bennett, Dore, Hunter), London, Department of Primary Care & Public Health Sciences, King's College London (Bunce), London, Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust (Nanavaty), Brighton, Wolverhampton and Midlands Eye Infirmary, New Cross Hospital, Royal Wolverhampton NHS Trust (Balaggan), Wolverhampton, United Kingdom.""}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Burr', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Bennett', 'Affiliation': ''}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Doré', 'Affiliation': ''}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': ''}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': ''}, {'ForeName': 'Mayank A', 'Initials': 'MA', 'LastName': 'Nanavaty', 'Affiliation': ''}, {'ForeName': 'Kamaljit S', 'Initials': 'KS', 'LastName': 'Balaggan', 'Affiliation': ''}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Wilkins', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000257']
1344,32789761,"Non-dispensing pharmacist integrated in the primary care team: effect on the quality of physician's prescribing, a non-randomised comparative study.","Background Especially in elderly with polypharmacy, medication can do harm. Clinical pharmacists integrated in primary care teams might improve quality of pharmaceutical care. Objective To assess the effect of non-dispensing clinical pharmacists integrated in primary care teams on general practitioners' prescribing quality. Setting This study was conducted in 25 primary care practices in the Netherlands. Methods Non-randomised, controlled, multi-centre, complex intervention study with pre-post comparison. First, we identified potential prescribing quality indicators from the literature and assessed their feasibility, validity, acceptability, reliability and sensitivity to change. Also, an expert panel assessed the indicators' health impact. Next, using the final set of indicators, we measured the quality of prescribing in practices where non-dispensing pharmacists were integrated in the team (intervention group) compared to usual care (two control groups). Data were extracted anonymously from the healthcare records. Comparisons were made using mixed models correcting for potential confounders. Main outcome measure Quality of prescribing, measured with prescribing quality indicators. Results Of 388 eligible indicators reported in the literature we selected 8. In addition, two more indicators relevant for Dutch general practice were formulated by an expert panel. Scores on all 10 indicators improved in the intervention group after introduction of the non-dispensing pharmacist. However, when compared to control groups, prescribing quality improved solely on the indicator measuring monitoring of the renal function in patients using antihypertensive medication: relative risk of a monitored renal function in the intervention group compared to usual care: 1.03 (95% CI 1.01-1.05, p-value 0.010) and compared to usual care plus: 1.04 (1.01-1.06, p-value 0.004). Conclusion This study did not demonstrate a consistent effect of the introduction of non-dispensing clinical pharmacists in the primary care team on the quality of physician's prescribing.This study is part of the POINT-study, which was registered at The Netherlands National Trial Register with trial registration number NTR-4389.",2020,This study did not demonstrate a consistent effect of the introduction of non-dispensing clinical pharmacists in the primary care team on the quality of physician's prescribing.,"['388 eligible indicators reported in the literature we selected 8', '25 primary care practices in the Netherlands']",[],"['feasibility, validity, acceptability, reliability and sensitivity to change', 'renal function', 'Quality of prescribing, measured with prescribing quality indicators']","[{'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0023866', 'cui_str': 'Literature'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]",[],"[{'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",388.0,0.0839224,This study did not demonstrate a consistent effect of the introduction of non-dispensing clinical pharmacists in the primary care team on the quality of physician's prescribing.,"[{'ForeName': 'Vivianne M', 'Initials': 'VM', 'LastName': 'Sloeserwij', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands. v.sloeserwij@umcutrecht.nl.'}, {'ForeName': 'Dorien L M', 'Initials': 'DLM', 'LastName': 'Zwart', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands.'}, {'ForeName': 'Ankie C M', 'Initials': 'ACM', 'LastName': 'Hazen', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Poldervaart', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands.'}, {'ForeName': 'Anne J', 'Initials': 'AJ', 'LastName': 'Leendertse', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands.'}, {'ForeName': 'Antoinette A', 'Initials': 'AA', 'LastName': 'de Bont', 'Affiliation': 'Erasmus School of Health Policy and Management, Erasmus University, Burgemeester Oudlaan 50, 3062 PA, Rotterdam, The Netherlands.'}, {'ForeName': 'Marcel L', 'Initials': 'ML', 'LastName': 'Bouvy', 'Affiliation': 'Department of Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, 3584 CG, Utrecht, The Netherlands.'}, {'ForeName': 'Niek J', 'Initials': 'NJ', 'LastName': 'de Wit', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands.'}, {'ForeName': 'Han J', 'Initials': 'HJ', 'LastName': 'de Gier', 'Affiliation': 'Department of Pharmacotherapy, -Epidemiology and -Economics, University of Groningen, Antonius Deusinglaan 1, Building 3214, 9713 AV, Groningen, The Netherlands.'}]",International journal of clinical pharmacy,['10.1007/s11096-020-01075-4']
1345,32785245,Impact of an acceptance facilitating intervention on psychotherapists' acceptance of blended therapy.,"Blended therapy is a new approach combining advantages of face-to-face psychotherapy and Internet- and mobile-based interventions. Acceptance is a fundamental precondition for its implementation. The aim of this study was to assess 1) the acceptance of psychotherapists towards blended therapy, 2) the effectiveness of an acceptance facilitating intervention (AFI) on psychotherapists' acceptance towards blended therapy and 3) to identify potential effect moderators. Psychotherapists (N = 284) were randomly assigned to a control (CG) or an intervention group (IG). The IG received a short video showing an example of blended therapy, the CG an attention placebo video. Both groups received a reliable online questionnaire assessing acceptance, effort expectancy, performance expectancy, facilitating conditions, social influence and internet anxiety. Between group differences were examined using t-tests and Mann-Whitney tests. Exploratory analysis was conducted to identify moderators. Psychotherapists in CG showed mixed baseline acceptance towards blended therapy (low = 40%, moderate = 33%, high = 27%). IG showed significantly higher acceptance compared to CG (d = .27, pone-sided = .029; low = 24%, moderate = 47%, high = 30%). Bootstrapped confidence intervals were overlapping. Performance expectancy (d = .35), effort expectancy (d = .44) and facilitating conditions (d = .28) were significantly increased (p < .05). No effects on social influence and internet anxiety were found (p>.05). Exploratory analysis indicated psychodynamic oriented psychotherapists profiting particularly from the AFI. Blended therapy is a promising approach to improve healthcare. Psychotherapists show mixed acceptance, which might be improvable by AFIs, particularly in subpopulations of initially rather skeptical psychotherapists. Forthcoming studies should extend the present study by shifting focus from attitudes to the impact of different forms of AFIs on uptake.",2020,"IG showed significantly higher acceptance compared to CG (d = .27, pone-sided = .029; low = 24%, moderate = 47%, high = 30%).",['Psychotherapists (N = 284'],"['control (CG', 'acceptance facilitating intervention (AFI', 'acceptance facilitating intervention']","['social influence and internet anxiety', 'effort expectancy', 'Performance expectancy', 'reliable online questionnaire assessing acceptance, effort expectancy, performance expectancy, facilitating conditions, social influence and internet anxiety']","[{'cui': 'C0557555', 'cui_str': 'Psychotherapist'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",284.0,0.0280326,"IG showed significantly higher acceptance compared to CG (d = .27, pone-sided = .029; low = 24%, moderate = 47%, high = 30%).","[{'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Yannik', 'Initials': 'Y', 'LastName': 'Terhorst', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'Grässle', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Freudenstein', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Nübling', 'Affiliation': 'Chamber of Psychotherapists Baden-Württemberg, Stuttgart, Germany.'}, {'ForeName': 'David Daniel', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Faculty of Behavioural and Movement Sciences, Clinical, Neuro- & Developmental Psychology, VU Amsterdam, Amsterdam, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0236995']
1346,32796502,Effects of a Physical Activity Program Potentiated with ICTs on the Formation and Dissolution of Friendship Networks of Children in a Middle-Income Country.,"This paper assesses the potential cohesion effect of a physical activity (PA) school-based intervention potentiated using text messages (SMS) through analyzing longitudinally the friendship network structure and the mechanisms of the formation and dissolution of friendships. Three schools ( n  = 125 participants) in Bogotá, Colombia, were randomly assigned into three groups: Modulo Activo Recreo Activo (MARA) + SMS (networks 1 and 2), MARA (networks 3 and 4), and control (no intervention: networks 5-7). We collected socio-economic, health-related, network structure, and intervention satisfaction variables in the baseline and after 10 weeks on July-November 2013. For each classroom network, we conducted four models using a temporal and static network approach to assess (1) temporal social network changes, (2) friendship homophily, (3) friendship formation and dissolution mechanisms, and (4) effect of SMS on the networks' cohesion. We found that (1) social cohesion emerged in the four intervened networks that were measured over time with transitivity and homophily driven by clustering, (2) the intervention affected the mechanisms of friendship formation and dissolution, and (3) MARA + SMS on average created more social cohesion and 3.8 more friendships than the program alone. Potentially, school-based interventions with information and communication technologies (ICT) such as MARA + SMS could encourage social cohesion among children. The particular characteristics of each school network need to be considered when developing school-based interventions.",2020,"We found that (1) social cohesion emerged in the four intervened networks that were measured over time with transitivity and homophily driven by clustering, (2) the intervention affected the mechanisms of friendship formation and dissolution, and (3) MARA + SMS on average created more social cohesion and 3.8 more friendships than the program alone.","['Children in a Middle-Income Country', 'Three schools ( n  = 125 participants) in Bogotá, Colombia', 'children']","['Modulo Activo Recreo Activo (MARA) + SMS (networks 1 and 2), MARA (networks 3 and 4), and control (no intervention: networks 5-7', 'physical activity (PA) school-based intervention potentiated using text messages (SMS', 'information and communication technologies (ICT) such as MARA + SMS', 'Physical Activity Program Potentiated with ICTs']",['Formation and Dissolution of Friendship Networks'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}]","[{'cui': 'C0445579', 'cui_str': 'Recreo'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0324975', 'cui_str': 'Dolichotis patagonum'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",,0.0241644,"We found that (1) social cohesion emerged in the four intervened networks that were measured over time with transitivity and homophily driven by clustering, (2) the intervention affected the mechanisms of friendship formation and dissolution, and (3) MARA + SMS on average created more social cohesion and 3.8 more friendships than the program alone.","[{'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Guerra', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Montes', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Andrés F', 'Initials': 'AF', 'LastName': 'Useche', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'Jaramillo', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Silvia A', 'Initials': 'SA', 'LastName': 'González', 'Affiliation': ""Healthy Active Living and Obesity Research Group, Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON K1H 8L1, Canada.""}, {'ForeName': 'Jose D', 'Initials': 'JD', 'LastName': 'Meisel', 'Affiliation': 'Social and Health Complexity Center, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Obando', 'Affiliation': 'INRIA, Institut du Cerveau et de la Moelle épinière, ICM, Inserm U 1127, CNRS UMR 7225, Sorbonne Université, 75013 Paris, France.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Cardozo', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Ruth F', 'Initials': 'RF', 'LastName': 'Hunter', 'Affiliation': ""Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast BT7 1NN, UK.""}, {'ForeName': 'Olga L', 'Initials': 'OL', 'LastName': 'Sarmiento', 'Affiliation': 'School of Medicine, Universidad de los Andes, Bogotá 111711, Colombia.'}]",International journal of environmental research and public health,['10.3390/ijerph17165796']
1347,32798840,Mouse nerve growth factor promotes neurological recovery in patients with acute intracerebral hemorrhage: A proof-of-concept study.,"BACKGROUND


ew drugs were confirmed to be effective in the treatments of neurological dysfunction caused by acute intracerebral hemorrhage (ICH). The present prospective clinical trial aims to evaluate the effect of mouse nerve growth factor (mNGF) on neurological function in patients with acute ICH.
METHODS


60 patients with acute spontaneous ICH were randomized to receive mNGF (mNGF group) and citicoline (control group) for 4 weeks within 24-72 h after onset, respectively. The primary outcome was difference in the neurological functional outcome at 3 months by the modified Rankin Scale score (mRS). The secondary outcomes were the changes in hematoma volume at 4 weeks and 3 months.
RESULTS


There were 55 patients receiving treatment (29 patients in the mNGF group, 26 patients in the control group). Among the patients, 46 patients finished the trial at 3 months; the odds of a shift towards death or dependence (mRS > 3) at 3 months in the mNGF group were lower than that in the control group with adjustment for age, sex, NIHSS at admission, and hematoma volume at admission (adjusted OR, 0.185; 95%CI, 0.059-0.582; P = 0.0039). The hematoma was gradually reduced in all 46 patients and absorbed after non-surgical treatment at 3 months. There was no significant difference in hematoma volume between the two groups. No serious adverse event was found.
CONCLUSIONS


The administration of mNGF and citicoline was well-tolerated in patients with acute ICH. mNGF was associated with improved neurological function and less disability in patients with ICH. Therefore, the quality of life of patients with ICH may be improved by mNGF.
TRIAL REGISTRATION


The trial is registered with the Chinese Clinical Trial Registry, number ChiCTR1800020258.",2020,There was no significant difference in hematoma volume between the two groups.,"['patients with acute ICH', 'patients with acute intracerebral hemorrhage', '55 patients receiving treatment (29 patients in the mNGF group, 26 patients in the control group', '60 patients with acute spontaneous ICH', 'patients with ICH']","['mNGF and citicoline', 'mNGF', 'mNGF (mNGF group) and citicoline (control group', 'mouse nerve growth factor (mNGF', 'Mouse nerve growth factor']","['quality of life', 'neurological functional outcome', 'hematoma', 'modified Rankin Scale score (mRS', 'changes in hematoma volume', 'neurological function', 'hematoma volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]","[{'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}]",60.0,0.0533032,There was no significant difference in hematoma volume between the two groups.,"[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'An', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Rehabilitation Medicine, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Yingsheng', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Shuyuan', 'Initials': 'S', 'LastName': 'Yue', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yongyue', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Biostatistics, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lei', 'Affiliation': 'Laboratory of Neuro-Trauma and Neurodegenerative Disorders, Tianjin Geriatrics Institute, Tianjin Medical University General Hospital, Tianjin, China; Department of Geriatrics, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jianning', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China. Electronic address: jianningzhang@hotmail.com.'}, {'ForeName': 'Rongcai', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China. Electronic address: jiang116216@163.com.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117069']
1348,32800842,Treating Home Versus Predialysis Blood Pressure Among In-Center Hemodialysis Patients: A Pilot Randomized Trial.,"RATIONALE & OBJECTIVE


Observational studies have reported a U-shaped association between blood pressure (BP) before a hemodialysis session and death. In contrast, because a linear association between out-of-dialysis-unit BP and death has been reported, home BP may be a better target for treatment. To test the feasibility of this approach, we conducted a pilot trial of treating home versus predialysis BP in hemodialysis patients.
STUDY DESIGN


A 4-month, parallel, randomized, controlled trial.
SETTINGS & PARTICIPANTS


50 prevalent hemodialysis patients in San Francisco and Seattle. Participants were randomly assigned using 1:1 block randomization, stratified by site.
INTERVENTIONS


To target home systolic BP (SBP) of 100-<140 mm Hg versus predialysis SBP of 100-<140mm Hg. Home and predialysis SBPs were ascertained every 2 weeks. Dry weight and BP medications were adjusted to reach the target SBP.
OUTCOMES


Primary outcomes were feasibility, adherence, safety. and tolerability.
RESULTS


50 of 70 (71%) patients who were approached agreed to participate. All enrollees completed the study except for 1 who received a kidney transplant. In the home BP treatment group, adherence to obtaining/reporting home BP was 97.4% (and consistent over the 4 months). There was no increased frequency of high (defined as SBP>200mm Hg; 0.2% vs 0%) or low (defined as<90mm Hg; 1.8% vs 1.2%) predialysis BP readings in the home versus predialysis treatment arms, respectively. However, participants in the home BP arm had higher frequency of fatigue (32% vs 16%).
LIMITATIONS


Small sample size.
CONCLUSIONS


This pilot trial demonstrates feasibility and high adherence to home BP measurement and treatment in hemodialysis patients. Larger trials to test the long-term feasibility, efficacy, and safety of home BP treatment in hemodialysis patients should be conducted.
FUNDERS


National Institutes of Health, Satellite Healthcare, and Northwest Kidney Centers.
TRIAL REGISTRATION


Registered at ClinicalTrials.gov with study number NCT03459807.",2020,"There was no increased frequency of high (defined as SBP>200 mmHg, 0.2% vs. 0%) or low (defined as <90 mmHg, 1.8% vs.1.2%) pre-dialysis BP readings in the home vs. pre-dialysis treatment arms, respectively.","['All enrollees completed the study except one who received a kidney transplant', 'Fifty out of seventy patients who were approached agreed to participate (71.4', 'Center Hemodialysis Patients', 'Fifty prevalent hemodialysis patients in San Francisco and Seattle', 'hemodialysis patients']","['Target home systolic BP (SBP', 'Treating Home Versus Predialysis Blood Pressure', 'treating home vs. pre-dialysis BP']","['pre-dialysis BP readings', 'Dry weight and BP medications', 'frequency of fatigue', 'frequency of high', 'adherence to obtaining/reporting home BP', 'feasibility, adherence, safety and tolerability']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1264634', 'cui_str': 'Pre-dialysis'}]","[{'cui': 'C1264634', 'cui_str': 'Pre-dialysis'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",50.0,0.0430896,"There was no increased frequency of high (defined as SBP>200 mmHg, 0.2% vs. 0%) or low (defined as <90 mmHg, 1.8% vs.1.2%) pre-dialysis BP readings in the home vs. pre-dialysis treatment arms, respectively.","[{'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Bansal', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, University of Washington, Seattle, WA. Electronic address: nbansal@nephrology.washington.edu.'}, {'ForeName': 'David V', 'Initials': 'DV', 'LastName': 'Glidden', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Rajnish', 'Initials': 'R', 'LastName': 'Mehrotra', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Raymond R', 'Initials': 'RR', 'LastName': 'Townsend', 'Affiliation': 'Division of Nephrology, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Jordana', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': 'Division of Nephrology, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Linke', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, University of Washington, Seattle, WA.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Palad', 'Affiliation': 'Division of Nephrology, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Larson', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, University of Washington, Seattle, WA.'}, {'ForeName': 'Chi-Yuan', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'Division of Nephrology, University of California, San Francisco, San Francisco, CA.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2020.06.014']
1349,32805428,Prophylactic action of lipid and non-lipid tear supplements in adverse environmental conditions: A randomised crossover trial.,"PURPOSE


To evaluate the prophylactic benefits of lipid-based and non-lipid-based artificial tear lubricants, in dry eye disease, after adverse environmental exposure.
METHODS


Twenty-eight participants with dry eye disease were recruited in a prospective, double-masked, randomised crossover trial. On separate days, participants were randomised to receive a single application of a lipid-containing tear supplement (Systane Complete) to one eye, and a non-lipid containing eye drop (Systane Ultra) to the contralateral eye. Participants were then exposed to a previously validated simulated adverse environment. Symptoms, non-invasive tear film breakup time, lipid layer grade, and tear meniscus height were assessed at three time points; baseline, following eye drop instillation, and after exposure to the adverse environment.
RESULTS


Both treatments effected improvements in symptoms and non-invasive tear film stability following instillation (all p < 0.05), although an improvement in lipid layer quality was limited to the lipid-containing nano-emulsion tear supplement (p = 0.003). Although protective effects were conferred by both treatments following exposure to the simulated adverse environment, more favourable symptomology scores, non-invasive tear film stability, and lipid layer quality were observed in the lipid-containing tear supplement group (all p < 0.05). No significant changes were observed in tear meniscus height in both treatment groups (all p > 0.05).
CONCLUSIONS


Both the lipid and non-lipid-based artificial tear supplement demonstrated prophylactic benefits in a simulated adverse environment. However, the ability to preserve tear film quality and reduce dry eye symptomology was greater with the lipid-containing eye drop.
TRIAL REGISTRATION NUMBER


ACTRN12619000361101.",2020,"Both treatments effected improvements in symptoms and non-invasive tear film stability following instillation (all p < 0.05), although an improvement in lipid layer quality was limited to the lipid-containing tear supplement (p = 0.003).","['Twenty-eight participants with dry eye disease', 'adverse environmental conditions']","['lipid-containing tear supplement (Systane® Complete) to one eye, and a non-lipid containing eye drop (Systane® Ultra) to the contralateral eye', 'lipid-based and non-lipid-based artificial tear lubricants', 'lipid and non-lipid containing tear supplements']","['lipid layer quality', 'symptoms and non-invasive tear film stability', 'favourable symptomology scores, non-invasive tear film stability, and lipid layer quality', 'tear meniscus height', 'Symptoms, non-invasive tear film break-up time, lipid layer grade, and tear meniscus height', 'tear film quality and reduce dry eye symptomology']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1655274', 'cui_str': 'Systane'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C0282222', 'cui_str': 'Lubricant'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1827565', 'cui_str': 'Tear meniscus height'}, {'cui': 'C0429495', 'cui_str': 'Tear film break-up time'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}]",28.0,0.0859293,"Both treatments effected improvements in symptoms and non-invasive tear film stability following instillation (all p < 0.05), although an improvement in lipid layer quality was limited to the lipid-containing tear supplement (p = 0.003).","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Muntz', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Marasini', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Michael T M', 'Initials': 'MTM', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Jennifer P', 'Initials': 'JP', 'LastName': 'Craig', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand. Electronic address: jp.craig@auckland.ac.nz.'}]",The ocular surface,['10.1016/j.jtos.2020.08.004']
1350,32805520,Blunted salivary cortisol response to psychosocial stress in women with posttraumatic stress disorder.,"Posttraumatic stress disorder (PTSD) is characterized by alterations in the hypothalamic-pituitary-adrenal (HPA) axis and sympathetic nervous system (SNS). There is evidence for a blunted HPA axis reactivity to psychosocial stress. Less is known about how the SNS reacts to psychosocial stress. Here, we compared the HPA axis and SNS responses to psychosocial stress and a non-stressful condition in patients with PTSD and in healthy individuals. Twenty-one women with PTSD and 32 healthy women participated in the Trier social stress test (TSST) and placebo TSST (P-TSST). We measured salivary cortisol, alpha amylase activity and blood pressure before and after the tests. Subjective perceived stress response was also assessed. We found a blunted cortisol response to the TSST in patients with PTSD compared with healthy participants 10 min (t (51) = -2.58, p = .01) and 25 min (t (51) = -2.16, p = .04) after TSST. We found no evidence for an increased SNS reactivity after psychosocial stress in patients with PTSD (all p > .05). Patients with PTSD, but not healthy participants, reported more dissociative symptoms (t (20) = -2.31, p = .03) and being more tired (t (20) = 2.90, p = .01) directly after TSST compared with the placebo condition. Our results suggest a blunted HPA stress reactivity and an increased subjective perceived stress response in female patients with PTSD. Longitudinal studies could test if these altered stress responses constitute a predisposition to or a cause of PTSD. Future studies should investigate whether these results are transferable to men.",2020,We found no evidence for an increased SNS reactivity after psychosocial stress in patients with PTSD (all p > .05).,"['Posttraumatic stress disorder (PTSD', 'patients with PTSD and in healthy individuals', 'women with posttraumatic stress disorder', 'patients with PTSD compared with healthy participants 10\xa0min (t (51)\xa0', 'female patients with PTSD', 'Twenty-one women with PTSD and 32 healthy women participated in the']","['TSST', 'Trier social stress test (TSST) and placebo TSST (P-TSST']","['blunted cortisol response', 'blunted HPA stress reactivity', 'Subjective perceived stress response', 'SNS reactivity', 'dissociative symptoms', 'salivary cortisol, alpha amylase activity and blood pressure', 'Blunted salivary cortisol response']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3715213', 'cui_str': '21'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",21.0,0.0110716,We found no evidence for an increased SNS reactivity after psychosocial stress in patients with PTSD (all p > .05).,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany. Electronic address: sophie.metz@charite.de.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Duesenberg', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Hellmann-Regen', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Institute of Cognitive Neuroscience, Faculty of Psychology, Ruhr University, Bochum, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.014']
1351,32813842,Evaluation of reservoirs in bleaching trays for at-home bleaching: a split-mouth single-blind randomized controlled equivalence trial.,"Objectives This randomized, split-mouth, single-blinded trial assessed whether the use of reservoirs in at-home bleaching trays is equivalent to non-reservoir trays. Our choice of an equivalence trial was based on the expectation that a non-reservoir tray is sufficient to produce a color change. Secondary outcomes such as tooth sensitivity (TS) and gingival irritation (GI) were also assessed. Methodology Forty-six patients were selected with canines shade A2 or darker. In half of the patient's arch, bleaching trays were made with reservoirs and the other half, without reservoirs. At-home bleaching was performed with carbamide peroxide (CP) 10% (3 h daily; 21 days). Color change was evaluated with a digital spectrophotometer (ΔE, ΔE00, and Whiteness Index) and shade guide units (ΔSGU) at baseline, during and one-month post-bleaching. TS and GI were assessed with a numeric scale (NRS) and a visual analog scale (VAS). Results After one month, the equivalence of reservoir and non-reservoir groups were observed in all color instruments (p>0.05). Fifteen and sixteen patients presented pain (absolute risk: 33% and 35%, 95%, confidence interval (CI) 21-46% and 23-49%) in the reservoir and non-reservoir side, respectively. The odds ratio for pain was 0.8 (95%CI 0.2-3.0) and the p-value was non-significant (p=1.0). TS intensity was similar between both groups in any of the pain scales (p>0.05). No difference in the GI was observed (p>0.05). Conclusions The protocol with reservoirs is equivalent in color change to the non-reservoir, although no superiority of the latter was observed in terms of reduced TS and GI with at-home 10% carbamide peroxide bleaching. Clinical Relevance The presence of reservoirs in a bleaching tray did not improve color change or affect tooth sensitivity and gingival irritation.",2020,"The protocol with reservoirs is equivalent in color change to the non-reservoir, although no superiority of the latter was observed in terms of reduced TS and GI with at-home 10% carbamide peroxide bleaching.",['Methodology Forty-six patients were selected with canines shade A2 or darker'],['carbamide peroxide (CP'],"['digital spectrophotometer (ΔE, ΔE00, and Whiteness Index) and shade guide units (ΔSGU', 'color change or affect tooth sensitivity and gingival irritation', 'tooth sensitivity (TS) and gingival irritation (GI', 'numeric scale (NRS) and a visual analog scale (VAS', 'TS intensity', 'GI', 'pain', 'odds ratio for pain']","[{'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}]","[{'cui': 'C0108342', 'cui_str': 'carbamide peroxide'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0475330', 'cui_str': 'Color change'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",46.0,0.0970237,"The protocol with reservoirs is equivalent in color change to the non-reservoir, although no superiority of the latter was observed in terms of reduced TS and GI with at-home 10% carbamide peroxide bleaching.","[{'ForeName': 'Eveline Claudia', 'Initials': 'EC', 'LastName': 'Martini', 'Affiliation': 'Departamento de Dentística Restauradora, Universidade Estadual de Ponta Grossa, Ponta Grossa, Paraná, Brasil.'}, {'ForeName': 'Michael Willian', 'Initials': 'MW', 'LastName': 'Favoreto', 'Affiliation': 'Departamento de Dentística Restauradora, Universidade Estadual de Ponta Grossa, Ponta Grossa, Paraná, Brasil.'}, {'ForeName': 'Fabiana Madalozzo', 'Initials': 'FM', 'LastName': 'Coppla', 'Affiliation': 'Departamento de Dentística Restauradora, Centro de Ensino Superior dos Campos Gerais, Ponta Grossa, Paraná, Brasil.'}, {'ForeName': 'Alessandro Dourado', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': 'Departamento de Dentística Restauradora, Universidade Estadual de Ponta Grossa, Ponta Grossa, Paraná, Brasil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': 'Departamento de Dentística Restauradora, Universidade Estadual de Ponta Grossa, Ponta Grossa, Paraná, Brasil.'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2020-0332']
1352,32814123,Application of continuous passive motion in patients with distal radius fractures: A randomized clinical trial.,"The aim of this study was to know if applying continuous passive motion (CPM) in addition to routine exercises is more effective than routine exercises alone in pain reduction, range of motion (ROM) and function improvement after distal radius fractures (DRFs). In this randomized controlled trial, 21 patients with non-stabilized DRF after pin removal were randomly assigned to experimental and control groups. The experimental group received stretching exercises with CPM machine for 2×15min per session. Both groups received routine exercises for 1h, three times a week for 4 weeks. The primary outcome measure was pain evaluated on a visual analog scale (VAS), and the secondary outcome measures were disability evaluated by the patient-rated wrist/hand evaluation and ROM (goniometry) at 4, 6, and 12 weeks. Univariate analysis of covariance (ANCOVA) and a one-way repeated measure mixed model analysis of variance (ANOVA) were used for data analysis. Twenty-one participants completed the 12-week follow-up. Pain relief, ROM and functional improvement revealed that the treatment was successful in both groups. We detected no significant differences (p>0.05) between the two groups at the end of the follow-up period regarding pain, ROM, and function. Using a CPM machine had no additional effect on pain reduction, ROM and function improvement compared with routine exercises in patients with DRF.",2020,"Using a CPM machine had no additional effect on pain reduction, ROM and function improvement compared with routine exercises in patients with DRF.","['patients with DRF', '21 patients with non-stabilized DRF after pin removal', 'patients with distal radius fractures']","['routine exercises', 'CPM machine', 'continuous passive motion', 'stretching exercises with CPM machine', 'continuous passive motion (CPM']","['pain, ROM, and function', 'Pain relief, ROM and functional improvement', 'pain evaluated on a visual analog scale (VAS', 'pain reduction, range of motion (ROM) and function improvement after distal radius fractures (DRFs', 'pain reduction, ROM and function improvement', 'disability evaluated by the patient-rated wrist/hand evaluation and ROM (goniometry']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",21.0,0.0547275,"Using a CPM machine had no additional effect on pain reduction, ROM and function improvement compared with routine exercises in patients with DRF.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shirzadi', 'Affiliation': 'Occupational Therapy, University of Social Welfare and Rehabilitation Sciences, Daneshjoo Blvd, Tehran, Iran. Electronic address: ashirzadi71@gmail.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Farzad', 'Affiliation': 'Occupational Therapy, University of Social Welfare and Rehabilitation Sciences, Daneshjoo Blvd, Tehran, Iran; Physical therapy, University of Western Ontario, London, Ontario, Canada. Electronic address: mfarzad@uwo.ca.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Farhoud', 'Affiliation': 'Orthopedic Surgery, Imam Hospital Complex, Tehran University of Medical Sciences, Joint Reconstruction Research Center, Iran. Electronic address: am_farhoud@yahoo.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Shafiee', 'Affiliation': 'Physical therapy, University of Western Ontario, London, Ontario, Canada. Electronic address: eshafiee@uwo.ca.'}]",Hand surgery & rehabilitation,['10.1016/j.hansur.2020.08.001']
1353,32816094,A 2 year physical activity and dietary intervention attenuates the increase in insulin resistance in a general population of children: the PANIC study.,"AIMS/HYPOTHESIS


We studied for the first time the long-term effects of a combined physical activity and dietary intervention on insulin resistance and fasting plasma glucose in a general population of predominantly normal-weight children.
METHODS


We carried out a 2 year non-randomised controlled trial in a population sample of 504 children aged 6-9 years at baseline. The children were allocated to a combined physical activity and dietary intervention group (306 children at baseline, 261 children at 2-year follow-up) or a control group (198 children, 177 children) without blinding. We measured fasting insulin and fasting glucose, calculated HOMA-IR, assessed physical activity and sedentary time by combined heart rate and body movement monitoring, assessed dietary factors by a 4 day food record, used the Finnish Children Healthy Eating Index (FCHEI) as a measure of overall diet quality, and measured body fat percentage (BF%) and lean body mass by dual-energy x-ray absorptiometry. The intervention effects on insulin, glucose and HOMA-IR were analysed using the intention-to-treat principle and linear mixed-effects models after adjustment for sex, age at baseline, and pubertal status at baseline and 2 year follow-up. The measures of physical activity, sedentary time, diet and body composition at baseline and 2 year follow-up were entered one-by-one as covariates into the models to study whether changes in these variables might partly explain the observed intervention effects.
RESULTS


Compared with the control group, fasting insulin increased 4.65 pmol/l less (absolute change +8.96 vs +13.61 pmol/l) and HOMA-IR increased 0.18 units less (+0.31 vs +0.49 units) over 2 years in the combined physical activity and dietary intervention group. The intervention effects on fasting insulin (regression coefficient β for intervention effect -0.33 [95% CI -0.62, -0.04], p = 0.026) and HOMA-IR (β for intervention effect -0.084 [95% CI -0.156, -0.012], p = 0.023) were statistically significant after adjustment for sex, age at baseline, and pubertal status at baseline and 2 year follow-up. The intervention had no effect on fasting glucose, BF% or lean body mass. Changes in total physical activity energy expenditure, light physical activity, moderate-to-vigorous physical activity, total sedentary time, the reported consumption of high-fat (≥60%) vegetable oil-based spreads, and FCHEI, but not a change in BF% or lean body mass, partly explained the intervention effects on fasting insulin and HOMA-IR.
CONCLUSIONS/INTERPRETATION


The combined physical activity and dietary intervention attenuated the increase in insulin resistance over 2 years in a general population of predominantly normal-weight children. This beneficial effect was partly mediated by changes in physical activity, sedentary time and diet but not changes in body composition.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01803776 Graphical abstract.",2020,"Compared with the control group, fasting insulin increased 4.65 pmol/l less (absolute change +8.96 vs +13.61 pmol/l) and HOMA-IR increased 0.18 units less (+0.31 vs +0.49 units) over 2 years in the combined physical activity and dietary intervention group.","['general population of children', '2\xa0years in a general population of predominantly normal-weight children', 'a general population of predominantly normal-weight children', '2\xa0year non-randomised controlled trial in a population sample of 504 children aged 6-9\xa0years at baseline', 'group (306 children at baseline, 261 children at 2-year follow-up) or a control group (198 children, 177 children) without blinding']","['combined physical activity and dietary intervention', 'dietary intervention']","['insulin, glucose and HOMA-IR', 'HOMA-IR', 'insulin resistance', 'physical activity, sedentary time, diet and body composition', 'fasting insulin and fasting glucose, calculated HOMA-IR, assessed physical activity and sedentary time by combined heart rate and body movement monitoring, assessed dietary factors by a 4\xa0day food record, used the Finnish Children Healthy Eating Index (FCHEI) as a measure of overall diet quality, and measured body fat percentage (BF%) and lean body mass by dual-energy x-ray absorptiometry', 'fasting glucose, BF% or lean body mass', 'fasting insulin and HOMA-IR', 'physical activity, sedentary time and diet', 'fasting insulin', 'total physical activity energy expenditure, light physical activity, moderate-to-vigorous physical activity, total sedentary time, the reported consumption of high-fat', 'insulin resistance and fasting plasma glucose']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442751', 'cui_str': 'Distance vision 6/9'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}]",504.0,0.0393305,"Compared with the control group, fasting insulin increased 4.65 pmol/l less (absolute change +8.96 vs +13.61 pmol/l) and HOMA-IR increased 0.18 units less (+0.31 vs +0.49 units) over 2 years in the combined physical activity and dietary intervention group.","[{'ForeName': 'Timo A', 'Initials': 'TA', 'LastName': 'Lakka', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland. timo.lakka@uef.fi.'}, {'ForeName': 'Niina', 'Initials': 'N', 'LastName': 'Lintu', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Juuso', 'Initials': 'J', 'LastName': 'Väistö', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Viitasalo', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Taisa', 'Initials': 'T', 'LastName': 'Sallinen', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Eero A', 'Initials': 'EA', 'LastName': 'Haapala', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Tuomo T', 'Initials': 'TT', 'LastName': 'Tompuri', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Soininen', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Panu', 'Initials': 'P', 'LastName': 'Karjalainen', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Theresia M', 'Initials': 'TM', 'LastName': 'Schnurr', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Santtu', 'Initials': 'S', 'LastName': 'Mikkonen', 'Affiliation': 'Department of Applied Physics, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Atalay', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Tuomas O', 'Initials': 'TO', 'LastName': 'Kilpeläinen', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tomi', 'Initials': 'T', 'LastName': 'Laitinen', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Kuopio University Hospital, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Laaksonen', 'Affiliation': 'Department of Medicine, Endocrinology and Clinical Nutrition, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Savonen', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Kuopio University Hospital, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Soren', 'Initials': 'S', 'LastName': 'Brage', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Schwab', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Jarmo', 'Initials': 'J', 'LastName': 'Jääskeläinen', 'Affiliation': 'Department of Pediatrics, Institute of Clinical Medicine, Kuopio University Hospital and University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Virpi', 'Initials': 'V', 'LastName': 'Lindi', 'Affiliation': 'University of Eastern Finland Library Kuopio, Kuopio, Finland.'}, {'ForeName': 'Aino-Maija', 'Initials': 'AM', 'LastName': 'Eloranta', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}]",Diabetologia,['10.1007/s00125-020-05250-0']
1354,32818546,Consumers' reactions to nutrition and ingredient labelling for wine - A cross-country discrete choice experiment.,"The purpose of this study is to examine consumers' reactions to the introduction of nutrition and ingredient labelling for wine, a product that is so far still exempt from mandatory nutrition and ingredient labelling. It also analyses the effect of positive and negative information about the use of ingredients in wine on consumers' choice. Representative samples for wine consumers from three distinctly different countries representing old and new wine markets (Australia, n = 745; Germany, n = 716; Italy, n = 715) completed a discrete choice experiment (DCE) with graphically simulated wine back labels. For each country, respondents were randomly allocated to a reference group and two different treatment conditions where they received newspaper-like information (positive, negative) before making choices. Results for the reference condition show that consumers across all three countries have a significant positive utility for detailed nutrition information. Instead, ingredient information only receives a positive utility in Italy, whereas German and Australian respondents do not receive utility from ingredient labelling. When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine. The treatment effect of positive media information on consumers' wine choice is lower than that of negative information. The results of the study have implications for the pending new regulation of wine labelling and for communication strategies of the wine industry that should actively inform consumers about the necessity of ingredients in wine production.",2020,"When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine.","['Representative samples for wine consumers from three distinctly different countries representing old and new wine markets (Australia, n\u202f=\u202f745; Germany, n\u202f=\u202f716; Italy, n\u202f=\u202f715) completed a']",['discrete choice experiment (DCE) with graphically simulated wine back labels'],[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1318228', 'cui_str': 'Market'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0043188', 'cui_str': 'Wine'}]",[],745.0,0.025423,"When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine.","[{'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Pabst', 'Affiliation': 'Geisenheim University, Von-Lade-Str. 1, 65395, Geisenheim, Germany. Electronic address: Evelyn.Pabst@hs-gm.de.'}, {'ForeName': 'Armando Maria', 'Initials': 'AM', 'LastName': 'Corsi', 'Affiliation': 'Adelaide Business School, The University of Adelaide, SA, 5005, Australia. Electronic address: Armando.Corsi@adelaide.edu.au.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Vecchio', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Via Università, 100, 80055, Portici (Naples), Italy. Electronic address: riccardo.vecchio@unina.it.'}, {'ForeName': 'Azzurra', 'Initials': 'A', 'LastName': 'Annunziata', 'Affiliation': 'Department of Economic and Legal Studies, University of Naples ""Parthenope"", Via G. Parisi, 13, 80133, Naples, Italy. Electronic address: azzurra.annunziata@uniparthenope.it.'}, {'ForeName': 'Simone Mueller', 'Initials': 'SM', 'LastName': 'Loose', 'Affiliation': 'Geisenheim University, Von-Lade-Str. 1, 65395, Geisenheim, Germany; Ehrenberg-Bass Instiute for Marketing Science, University of South, North Terrace, Adelaide, SA, 5000, Australia. Electronic address: Simone.Loose@hs-gm.de.'}]",Appetite,['10.1016/j.appet.2020.104843']
1355,32818573,"Clinical evaluation of the pharmacological impact of ashwagandha root extract on sleep in healthy volunteers and insomnia patients: A double-blind, randomized, parallel-group, placebo-controlled study.","ETHNOPHARMACOLOGICAL RELEVANCE


Ashwagandha (Withania somnifera (L.) Dunal.) is long known for its sleep-inducing effects. Ashwagandha can be proposed as an alternative to the recommended present treatments for insomnia. This study aimed to evaluate the pharmacological effect of Ashwagandha root extract on sleep in healthy subjects and also in the subjects having insomnia.
MATERIAL AND METHODS


We performed a randomized, parallel-group, stratified design, placebo-controlled study. A total of 80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia) were assigned to two groups, either Ashwagandha or placebo and studied for 8-weeks. The assessment was done based on the sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake After Sleep Onset, Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire. Safety and adverse events along with the concomitant medication were also assessed.
RESULTS


In both healthy and insomnia subjects, there was a significant improvement in the sleep parameters in the Ashwagandha root extract supplemented group. The improvement was found more significant in insomnia subjects than healthy subjects. Repeat measure Analysis of variance (ANOVA) confirmed the significant improvement in SOL (p 0.013), HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients. A two-way ANOVA was used to confirm the outcomes that denoted sleep onset latency (p < 0.0001) and sleep efficiency (p < 0.0001) as the most improved parameters, followed by TST (p < 0.002) and WASO(p < 0.040). All these parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality) were also statistically assessed for the significant improvement within the group both for the treatment, and the placebo groups in the healthy and the insomnia datasets. Obtained results suggest statistically significant (p < 0.0001) changes between the baseline values and the end of the study results except for the HAM-A and the mental alertness scoresn the healthy subject group.
CONCLUSION


The present study confirms that Ashwagandha root extract can improve sleep quality and can help in managing insomnia. Ashwagandha root extract was well tolerated by all the participants irrespective of their health condition and age. Additional clinical trials are required to generalize the outcome.",2020,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","['80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia', 'healthy subjects and also in the subjects having insomnia', 'healthy volunteers and insomnia patients']","['Ashwagandha root extract', 'ashwagandha root extract', 'Ashwagandha or placebo', 'placebo']","['parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality', 'sleep parameters', 'insomnia subjects', 'mental alertness', 'sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake', 'sleep efficiency', 'Safety and adverse events', 'sleep quality', 'SOL', 'Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0549164', 'cui_str': 'Mental alertness'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",80.0,0.0352543,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","[{'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Langade', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India. Electronic address: deepak.langade@dypatil.edu.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Thakare', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India. Electronic address: vaishali.thakare@dypatil.edu.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Kanchi', 'Affiliation': 'NAMO Medical Education and Research Institute, Silvassa, DNH&DD, India. Electronic address: rksubodh@gmail.com.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kelgane', 'Affiliation': 'Maharashtra Emergency Medical Services, Defence Area, Pimple Gurav, Pimpri-Chinchwad, 411027, Maharashtra, India. Electronic address: sunildrkelgane@gmail.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113276']
1356,32819465,Pulmonary Artery Denervation for Patients With Residual Pulmonary Hypertension After Pulmonary Endarterectomy.,"BACKGROUND


Pulmonary artery denervation (PADN) procedure has not been applied to patients with residual chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary endarterectomy (PEA).
OBJECTIVES


This study sought to assess the safety and efficacy of PADN using remote magnetic navigation in patients with residual CTEPH after PEA.
METHODS


Fifty patients with residual CTEPH despite medical therapy at least 6 months after PEA, who had mean pulmonary artery pressure ≥25 mm Hg or pulmonary vascular resistance (PVR) > 400 dyn‧s‧cm -5  based on right heart catheterization were randomized to treatment with PADN (PADN group; n = 25) using remote magnetic navigation for ablation or medical therapy with riociguat (MED group; n = 25). In the MED group, a sham procedure with mapping but no ablation was performed. The primary endpoint was PVR at 12 months after randomization. Key secondary endpoint included 6-min walk test.
RESULTS


After PADN procedure, 2 patients (1 in each group) developed groin hematoma that resolved without any consequences. At 12 months, mean PVR reduction was 258 ± 135 dyn‧s‧cm -5  in the PADN group versus 149 ± 73 dyn‧s‧cm -5  in the MED group, mean between-group difference was 109 dyn‧s‧cm -5  (95% confidence interval: 45 to 171; p = 0.001). The 6-min walk test distance was significantly increased in the PADN group as compared to distance in the MED group (470 ± 84 m vs. 399 ± 116 m, respectively; p = 0.03).
CONCLUSIONS


PADN in patients with residual CTEPH resulted in substantial reduction of PVR at 12 months of follow-up, accompanied by improved 6-min walk test.",2020,"The 6-min walk test distance was significantly increased in the PADN group as compared to distance in the MED group (470 ± 84 m vs. 399 ± 116 m, respectively; p = 0.03).
","['Fifty patients with residual CTEPH despite medical therapy at least 6\xa0months after PEA, who had mean pulmonary artery pressure\xa0≥25', 'patients with residual chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary endarterectomy (PEA', 'patients with residual CTEPH after PEA', ' 400 dyn‧s‧cm -5  based on right heart catheterization', 'Patients With Residual Pulmonary Hypertension']","['PADN (PADN group; n\xa0=\xa025) using remote magnetic navigation for ablation or medical therapy with riociguat (MED group; n\xa0=\xa025', 'PADN', 'Pulmonary artery denervation (PADN) procedure']","['6-min walk test', '6-min walk test distance', 'substantial reduction of PVR', 'groin hematoma', 'safety and efficacy', 'Hg or pulmonary vascular resistance', 'mean PVR reduction', 'PVR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C2363973', 'cui_str': 'Chronic thromboembolic pulmonary hypertension'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2066034', 'cui_str': 'Pulmonary endarterectomy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0189896', 'cui_str': 'Catheterization of right heart'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}]","[{'cui': 'C0034052', 'cui_str': 'Pulmonary artery structure'}, {'cui': 'C0011307', 'cui_str': 'Denervation - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C2717561', 'cui_str': 'riociguat'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0585249', 'cui_str': 'Hematoma of groin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",50.0,0.0567703,"The 6-min walk test distance was significantly increased in the PADN group as compared to distance in the MED group (470 ± 84 m vs. 399 ± 116 m, respectively; p = 0.03).
","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Romanov', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation. Electronic address: abromanov@mail.ru.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Cherniavskiy', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Nataliya', 'Initials': 'N', 'LastName': 'Novikova', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Edemskiy', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Ponomarev', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Vitaliy', 'Initials': 'V', 'LastName': 'Shabanov', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Losik', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Elesin', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Ilya', 'Initials': 'I', 'LastName': 'Stenin', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Mikheenko', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Zhizhov', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Kretov', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Pokushalov', 'Affiliation': 'Russian Scientific Society of Clinical Electrophysiology, Arrhythmology, and Cardiac Pacing, Moscow, Russian Federation.'}, {'ForeName': 'Sunny S', 'Initials': 'SS', 'LastName': 'Po', 'Affiliation': 'Heart Rhythm Institute, University of Oklahoma Health Science Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Tamila V', 'Initials': 'TV', 'LastName': 'Martynyuk', 'Affiliation': 'A.L. Myasnikov Institute of Clinical Cardiology, Russian Cardiology Research and Production Complex, Ministry of Health of the Russian Federation, Moscow, Russian Federation.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Steinberg', 'Affiliation': 'Clinical Cardiovascular Research Center, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.06.064']
1357,32789625,"Awareness, Willingness, and Perceived Efficacy of Pre-exposure Prophylaxis among Adolescent Sexual Minority Males.","Despite the approval of PrEP for adolescents by the FDA in 2018, little is known about the awareness and attitudes about PrEP use among adolescent sexual minority males, who are at the greatest risk for HIV. We analyzed baseline data from the MyPEEPS Mobile study, a multi-site randomized controlled trial evaluating the effectiveness of a mobile behavioral HIV prevention intervention. A substantial proportion (68.2%) of study participants (ages 13-18) had previously heard about PrEP, and an overwhelming majority (90.8%) reported willingness to take PrEP, to prevent HIV. On the other hand, only about one third (34.6%) of participants indicated that taking a daily HIV pill would be ""very"" or ""completely"" effective in preventing HIV when having sex without a condom. These findings suggest that high awareness and willingness to use PrEP across various adolescent subgroups present opportunities for increased PrEP advocacy among this young age group.",2020,"A substantial proportion (68.2%) of study participants (ages 13-18) had previously heard about PrEP, and an overwhelming majority (90.8%) reported willingness to take PrEP, to prevent HIV.","['adolescent sexual minority males', 'Adolescent Sexual Minority Males']",['mobile behavioral HIV prevention intervention'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0544438,"A substantial proportion (68.2%) of study participants (ages 13-18) had previously heard about PrEP, and an overwhelming majority (90.8%) reported willingness to take PrEP, to prevent HIV.","[{'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Gordián-Arroyo', 'Affiliation': 'Columbia University, Mailman School of Public Health, New York, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': ""Department of Pediatrics, Northwestern's Feinberg School of Medicine, Chicago, IL, USA.""}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Kuhns', 'Affiliation': ""Department of Pediatrics, Northwestern's Feinberg School of Medicine, Chicago, IL, USA.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Pearson', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Birmingham AIDS Outreach, Birmingham, AL, USA.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Batey', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Asa', 'Initials': 'A', 'LastName': 'Radix', 'Affiliation': 'Callen-Lorde Community Health Center, New York, NY, USA.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Belkind', 'Affiliation': 'Callen-Lorde Community Health Center, New York, NY, USA.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Hidalgo', 'Affiliation': ""Keck School of Medicine of the University of Southern California/Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Hirshfield', 'Affiliation': 'SUNY Downstate Health Sciences University, Department of Medicine, Brooklyn, NY, USA.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Schrimshaw', 'Affiliation': 'University of Central Florida, College of Medicine, Orlando, FL, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Schnall', 'Affiliation': 'Columbia University, School of Nursing, New York, NY, USA. rb897@columbia.edu.'}]",Journal of urban health : bulletin of the New York Academy of Medicine,['10.1007/s11524-020-00447-5']
1358,32783799,Baseline Characteristics of Study Participants in the Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Trial.,"Recurrent enteric infections and micronutrient deficiencies, including deficiencies in the tryptophan-kynurenine-niacin pathway, have been associated with environmental enteric dysfunction, potentially contributing to poor child growth and development. We are conducting a randomized, placebo-controlled, 2 × 2 factorial interventional trial in a rural population in Haydom, Tanzania, to determine the effect of 1) antimicrobials (azithromycin and nitazoxanide) and/or 2) nicotinamide, a niacin vitamer, on attained length at 18 months. Mother/infant dyads were enrolled within 14 days of the infant's birth from September 2017 to September 2018, with the follow-up to be completed in February 2020. Here, we describe the baseline characteristics of the study cohort, risk factors for low enrollment weight, and neonatal adverse events (AEs). Risk factors for a low enrollment weight included being a firstborn child (-0.54 difference in weight-for-age  z -score [WAZ] versus other children, 95% CI: -0.71, -0.37), lower socioeconomic status (-0.28, 95% CI: -0.43, -0.12 difference in WAZ), and birth during the preharvest season (November to March) (-0.22, 95% CI: -0.33, -0.11 difference in WAZ). The most common neonatal serious AEs were respiratory tract infections and neonatal sepsis (2.2 and 1.4 events per 100 child-months, respectively). The study cohort represents a high-risk population for whom interventions to improve child growth and development are urgently needed. Further analyses are needed to understand the persistent impacts of seasonal malnutrition and the interactions between seasonality, socioeconomic status, and the study interventions.",2020,"The most common neonatal serious AEs were respiratory tract infections and neonatal sepsis (2.2 and 1.4 events per 100 child-months, respectively).","[""Mother/infant dyads were enrolled within 14 days of the infant's birth from September 2017 to September 2018, with the follow-up to be completed in February 2020"", 'rural population in Haydom, Tanzania', 'Study Participants in the Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Trial']","['antimicrobials (azithromycin and nitazoxanide) and/or 2) nicotinamide, a niacin vitamer', 'placebo']","['lower socioeconomic status', 'respiratory tract infections and neonatal sepsis']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035962', 'cui_str': 'Rural Population'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0068788', 'cui_str': 'nitazoxanide'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0456103', 'cui_str': 'Sepsis of the newborn'}]",,0.15935,"The most common neonatal serious AEs were respiratory tract infections and neonatal sepsis (2.2 and 1.4 events per 100 child-months, respectively).","[{'ForeName': 'Tarina C', 'Initials': 'TC', 'LastName': 'Parpia', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Elwood', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Scharf', 'Affiliation': 'Department of Pediatrics, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Joann M', 'Initials': 'JM', 'LastName': 'McDermid', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Anne W', 'Initials': 'AW', 'LastName': 'Wanjuhi', 'Affiliation': 'Department of Pediatrics, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Rogawski McQuade', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gratz', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Erling', 'Initials': 'E', 'LastName': 'Svensen', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Swann', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Donowitz', 'Affiliation': ""Division of Infectious Disease, Children's Hospital of Richmond at Virginia Commonwealth University, Richmond, Virginia.""}, {'ForeName': 'Samwel', 'Initials': 'S', 'LastName': 'Jatosh', 'Affiliation': 'Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania.'}, {'ForeName': 'Siphael', 'Initials': 'S', 'LastName': 'Katengu', 'Affiliation': 'Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania.'}, {'ForeName': 'Paschal', 'Initials': 'P', 'LastName': 'Mdoe', 'Affiliation': 'Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania.'}, {'ForeName': 'Sokoine', 'Initials': 'S', 'LastName': 'Kivuyo', 'Affiliation': 'National Institute for Medical Research, Muhimbili Medical Research Centre, Dar es Salaam, Tanzania.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Houpt', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'DeBoer', 'Affiliation': 'Department of Pediatrics, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Estomih', 'Initials': 'E', 'LastName': 'Mduma', 'Affiliation': 'Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Platts-Mills', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0918']
1359,32785044,Be Health e  for Your Heart: A Pilot Randomized Controlled Trial Evaluating a Web-Based Behavioral Intervention to Improve the Cardiovascular Health of Women with a History of Preeclampsia.,"This pilot randomized controlled trial (RCT) aimed to determine the acceptability and preliminary efficacy of a web-based cardiovascular disease (CVD) prevention intervention for women following preeclampsia. Australian women with a recent history (≤4 years post diagnosis) of preeclampsia were randomized into two study arms: (1) Be Health e  for your Heart, a web-based behavioral intervention or; (2) Control, access to the National Heart Foundation website. Assessments were conducted at baseline, and after three months. Intervention acceptability and impact on absolute CVD 30-year risk score, CVD risk markers and health behaviors were assessed. Twenty-four of 31 (77.4%) women completed the three-month assessment. Eleven out of 13 intervention participants (84.6%) agreed/strongly agreed they were satisfied with the program, with a mean score of 4.2 ± 0.9 (maximum of five). There were no significant between or within group differences in absolute CVD risk, CVD risk markers or health behaviors from baseline to three months. Women with a history of preeclampsia were successfully recruited and retained and they reported high levels of acceptability with the Be Health e  for your Heart program. Further research is therefore needed from powered trials to determine the impact of web-based lifestyle interventions on CVD risk in this at-risk group.",2020,"There were no significant between or within group differences in absolute CVD risk, CVD risk markers or health behaviors from baseline to three months.","['Australian women with a recent history (≤4 years post diagnosis) of preeclampsia', 'Twenty-four of 31 (77.4', 'Women with a History of Preeclampsia', 'Women with a history of preeclampsia', 'women following preeclampsia', 'Your Heart']","['Web-Based Behavioral Intervention', 'web-based cardiovascular disease (CVD) prevention intervention']","['absolute CVD risk, CVD risk markers or health behaviors', 'absolute CVD 30-year risk score, CVD risk markers and health behaviors', 'Cardiovascular Health']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C4076023', 'cui_str': 'History of pre-eclampsia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",,0.218305,"There were no significant between or within group differences in absolute CVD risk, CVD risk markers or health behaviors from baseline to three months.","[{'ForeName': 'Melinda J', 'Initials': 'MJ', 'LastName': 'Hutchesson', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Vanessa A', 'Initials': 'VA', 'LastName': 'Shrewsbury', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Vincze', 'Affiliation': 'School of Allied Health Sciences & Menzies Health Institute Queensland, Griffith University, Gold Coast, QLD 4222, Australia.'}, {'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'Campbell', 'Affiliation': 'School of Psychology, Faculty of Science, The University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Callister', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Biomedical Sciences and Pharmacy, Faculty of Health and Medicine, The University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Felicity', 'Initials': 'F', 'LastName': 'Park', 'Affiliation': 'Department of Maternal Foetal Medicine, John Hunter Hospital, Newcastle, NSW 2305, Australia.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Schumacher', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, NSW 2308, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17165779']
1360,32785881,Calcipotriol/Betamethasone Dipropionate Cutaneous Foam Treatment for Psoriasis in Patients With BSA 5-15% and PGA ≥ 3: Post-Hoc Analysis From Three Randomized Controlled Trials.,"INTRODUCTION


Psoriasis is a chronic, inflammatory disease, which ranges in severity from mild to severe. Although topical therapies are frequently used to treat mild disease, they are not routinely used to treat patients with moderate-to-severe disease who have a larger proportion of their body surface area (BSA) affected (≥ 5% BSA). Based on well-controlled trials in adults with mild-to-severe disease, fixed-dose combination calcipotriol 50 μg/g + betamethasone dipropionate 0.5 mg/g (Cal/BD) cutaneous foam has been approved (Enstilar®, LEO Pharma) in the USA and EU for the treatment of psoriasis vulgaris for up to 4 weeks in adults. In this post-hoc subgroup analysis, we used pooled data from phase II/III trials to investigate the efficacy and safety of Cal/BD cutaneous foam in patients with moderate-to-severe psoriasis.
METHODS


Patients included in this analysis had psoriasis affecting 5-15% BSA and a physician's global assessment (PGA) ≥ 3. Endpoints included: treatment success by PGA (rating: clear/almost clear), patient's global assessment (PaGA) at week 4 (rating: clear/very mild) and safety.
RESULTS


A total of 340 patients in the three randomized trials met the BSA/PGA inclusion criteria, of whom 254 were treated with Cal/BD foam and 86 with vehicle foam. Treatment success by PGA and PaGA at week 4 was achieved in 143 (58.1%) and 138 (56.1%) patients receiving Cal/BD foam, respectively, versus three (3.6%) and 14 (16.7%) patients receiving vehicle foam. Sixty-six adverse events (AEs) occurred in 47 (18.5%) patients receiving Cal/BD foam and 11 AEs occurred in 11 (12.8%) patients receiving vehicle foam. Three severe AEs and 15 non-serious treatment-related AEs occurred in patients receiving Cal/BD foam.
CONCLUSION


The results from three clinical trials analyzed together show that topical Cal/BD foam is well tolerated and efficacious for treating patients with moderate-to-severe disease. Data support Cal/BD foam as a potential topical therapy for moderate-to-severe psoriasis.
TRIAL REGISTRATIONS


ClinicalTrials.gov registration numbers: NCT01866163, NCT02132936, NCT01536886.",2020,"Treatment success by PGA and PaGA at week 4 was achieved in 143 (58.1%) and 138 (56.1%) patients receiving Cal/BD foam, respectively, versus three (3.6%) and 14 (16.7%) patients receiving vehicle foam.","[""Patients included in this analysis had psoriasis affecting 5-15% BSA and a physician's global assessment (PGA)\u2009≥\u20093"", '340 patients in the three randomized trials met the BSA/PGA inclusion criteria, of whom 254 were treated with Cal/BD foam and 86 with vehicle foam', 'adults with mild-to-severe disease, fixed-dose combination calcipotriol 50 μg', 'patients with moderate-to-severe psoriasis', 'Psoriasis in Patients With BSA 5-15% and PGA\u2009≥\u20093', 'patients with moderate-to-severe disease', 'patients with moderate-to-severe disease who have a larger proportion of their body surface area (BSA) affected (≥\u20095% BSA']","['g + betamethasone dipropionate 0.5', 'Calcipotriol/Betamethasone Dipropionate Cutaneous Foam']","[""treatment success by PGA (rating: clear/almost clear), patient's global assessment (PaGA) at week 4 (rating: clear/very mild) and safety"", 'tolerated and efficacious']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3653162', 'cui_str': 'calcipotriol, combinations'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0549177', 'cui_str': 'Large'}]","[{'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C1160727', 'cui_str': 'Cutaneous foam'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",340.0,0.163511,"Treatment success by PGA and PaGA at week 4 was achieved in 143 (58.1%) and 138 (56.1%) patients receiving Cal/BD foam, respectively, versus three (3.6%) and 14 (16.7%) patients receiving vehicle foam.","[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Iversen', 'Affiliation': 'Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark. lars.iversen@clin.au.dk.'}, {'ForeName': 'Merle', 'Initials': 'M', 'LastName': 'Kurvits', 'Affiliation': 'Biostatistics Department, LEO Pharma, Ballerup, Denmark.'}, {'ForeName': 'Anja Marieke', 'Initials': 'AM', 'LastName': 'Snel-Prentø', 'Affiliation': 'Global Medical Affairs, LEO Pharma, Ballerup, Denmark.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Division of Dermatology, Baylor Scott & White Health, Dallas, TX, USA.'}]",Dermatology and therapy,['10.1007/s13555-020-00419-2']
1361,32790734,"Comparison of the MultiViewScope Stylet Scope and the direct laryngoscope with the Miller blade for the intubation in normal and difficult pediatric airways: A randomized, crossover, manikin study.","BACKGROUND


Managing difficult pediatric airway is challenging. The MultiViewScope (MVS) Stylet Scope is reported to be useful in difficult pediatric airway. In this randomized crossover study, we compared the effectiveness of the MVS Stylet Scope to a standard direct laryngoscope with Miller #1 blade in simulated normal and difficult airways.
METHODS


Fifteen expert anesthesiologists and Fifteen anesthesiology residents participated in the study. Participants were asked to perform intubation with the Airsim Baby manikin first, and then with the Airsim Pierre Robin manikin. Participants in each group used the intubation devices in a randomized order. The primary outcome was the time of successful intubation. The secondary outcomes were the force exerted on the incisors during intubation, Cormack-Lehane scale, the difficulty of intubation.
RESULTS


There were no differences between MVS Stylet Scope and Direct laryngoscope in the time of successful intubation by the expert anesthesiologists or the anesthesiology residents in a normal or difficult pediatric airway. MVS Stylet Scope significantly improved the force exerted on the incisors during intubation in the expert anesthesiologists or the anesthesiology residents in a normal or difficult pediatric airway. MVS Stylet Scope significantly improved Cormack-Lehane scale, and the difficulty of intubation with difficult pediatric airway situation in both expert anesthesiologists and anesthesiology residents.
CONCLUSIONS


Although less forces on the incisors and improved view of glottis were observed with the MVS Stylet Scope, MVS Stylet Scope did not shorten the time of intubation. The results of this study mean that the MVS Stylet Scope may be a less invasive airway devise than the direct laryngoscope with the Miller blade in the pediatric airway management. For the next step, we need to evaluate the MVS Stylet Scope in the real patients as an observational study.",2020,There were no differences between MVS Stylet Scope and Direct laryngoscope in the time of successful intubation by the expert anesthesiologists or the anesthesiology residents in a normal or difficult pediatric airway.,"['Fifteen expert anesthesiologists and Fifteen anesthesiology residents participated in the study', 'normal and difficult pediatric airways']","['MultiViewScope', 'direct laryngoscope with the Miller blade', 'MVS Stylet Scope']","['time of intubation', 'time of successful intubation', 'MultiViewScope (MVS', 'Cormack-Lehane scale', 'force exerted on the incisors during intubation, Cormack-Lehane scale, the difficulty of intubation']","[{'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C0183663', 'cui_str': 'Stylet'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",,0.0337827,There were no differences between MVS Stylet Scope and Direct laryngoscope in the time of successful intubation by the expert anesthesiologists or the anesthesiology residents in a normal or difficult pediatric airway.,"[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Godai', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Moriyama', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Kanmura', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan.'}]",PloS one,['10.1371/journal.pone.0237593']
1362,32795597,Racial disparities in out-of-hospital cardiac arrest interventions and survival in the Pragmatic Airway Resuscitation Trial.,"BACKGROUND


Prior studies have reported racial disparities in survival from out-of-hospital cardiac arrest (OHCA). However, these studies did not evaluate the association of race with OHCA course of care and outcomes. The purpose of this study was to evaluate racial disparities in OHCA airway placement success and patient outcomes in the multicenter Pragmatic Airway Resuscitation Trial (PART).
METHOD


We conducted a secondary analysis of adult OHCA patients enrolled in PART. The parent trial randomized subjects to initial advanced airway management with laryngeal tube or endotracheal intubation. For this analysis, the primary independent variable was patient race categorized by emergency medical services (EMS) as white, black, Hispanic, other, and unknown. We used general estimating equations to examine the association of race with airway attempt success, 72-h survival, and survival to hospital discharge, adjusting for sex, age, witness status, bystander cardiopulmonary resuscitation (CPR), initial rhythm, arrest location, and PART randomization cluster.
RESULTS


Of 3002 patients, EMS-assessed race as 1537 white, 860 black, 163 Hispanic, 90 other, and 352 unknown. Initial shockable rhythms (13.8% vs. 21.5%, p < 0.001), bystander CPR (35.6% vs. 51.4%, p < 0.001), and survival to hospital discharge (7.6% vs. 10.8%, p = 0.011) were lower for black compared to white patients. After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
CONCLUSIONS


In one of the largest studies evaluating differences in prehospital airway interventions and outcomes by EMS-assessed race for OHCA patients, we found no significant adjusted differences between airway success or survival outcomes.",2020,"After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
","[' EMS-assessed race as 1537 white, 860 black, 163 Hispanic, 90 other, and 352 unknown', '3002 patients', 'adult OHCA patients enrolled in PART']",['initial advanced airway management with laryngeal tube or endotracheal intubation'],"['association of race with airway attempt success, 72-h survival, and survival to hospital discharge, adjusting for sex, age, witness status, bystander cardiopulmonary resuscitation (CPR), initial rhythm, arrest location, and PART randomization cluster', 'airway success, 72-h survival, and survival to hospital discharge by race', 'Initial shockable rhythms', 'survival to hospital discharge', 'bystander CPR', 'airway success or survival outcomes']","[{'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",3002.0,0.089249,"After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lupton', 'Affiliation': 'Oregon Health & Science University, United States. Electronic address: lupton@ohsu.edu.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Schmicker', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Medical College of Wisconsin, United States.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Blewer', 'Affiliation': 'Duke University School of Medicine, United States.'}, {'ForeName': 'Clifton', 'Initials': 'C', 'LastName': 'Callaway', 'Affiliation': 'University of Pittsburgh School of Medicine, United States.'}, {'ForeName': 'Jestin N', 'Initials': 'JN', 'LastName': 'Carlson', 'Affiliation': 'Allegheny Health Network, United States.'}, {'ForeName': 'M Riccardo', 'Initials': 'MR', 'LastName': 'Colella', 'Affiliation': 'Medical College of Wisconsin, United States.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Oregon Health & Science University, United States.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Herren', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Nichol', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'University of Texas Health Science Center at Houston, United States.'}, {'ForeName': 'Mohamud R', 'Initials': 'MR', 'LastName': 'Daya', 'Affiliation': 'Oregon Health & Science University, United States.'}]",Resuscitation,['10.1016/j.resuscitation.2020.08.004']
1363,32795738,Predictors of receptivity to an alcohol intervention among mandated students.,"OBJECTIVE


Students in violation of campus alcohol policy often must participate in an alcohol risk reduction intervention, and some mandated students express overt resistance to change. This study tested a priori hypotheses about psychological variables that might predict receptivity to an online brief alcohol intervention.
METHOD


Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations. Before their mandated online alcohol intervention, they completed a baseline assessment consisting of demographics and questionnaires about their alcohol use, attitudes toward moderate and heavy drinking, beliefs about the centrality of alcohol in college life, perceived descriptive and injunctive drinking norms, trait defensiveness, social desirability and response to the event leading to their sanction. They also responded to a set of questions about how interested in, open-minded, and likely to benefit they were from the computer-delivered alcohol intervention they were about to take.
RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
CONCLUSIONS


Among students mandated to participate in an alcohol intervention, openness to benefitting from the intervention varies in predictable ways. Because intervention receptiveness is associated with post-intervention change, we offer suggestions to tailor mandated interventions in ways that might improve outcomes.",2020,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","['Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations', 'mandated students']",['alcohol intervention'],"['heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242456', 'cui_str': 'Policy'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",193.0,0.0120224,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","[{'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Carey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Behavioral and Social Sciences, Brown University School of Public Health, United States. Electronic address: Kate_Carey@Brown.edu.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'DiBello', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Psychology, City University of New York, Brooklyn College, United States.'}, {'ForeName': 'Elora E', 'Initials': 'EE', 'LastName': 'Orazio', 'Affiliation': 'College of Community and Public Affairs, Binghamton University, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Hatch', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States.'}, {'ForeName': 'Nadine R', 'Initials': 'NR', 'LastName': 'Mastroleo', 'Affiliation': 'Department of Psychology, Binghamton University, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106605']
1364,32803636,Influence of green tea consumption on endoxifen steady-state concentration in breast cancer patients treated with tamoxifen.,"BACKGROUND


Many cancer patients use additional herbs or supplements in combination with their anti-cancer therapy. Green tea-active ingredient epigallocatechin-3-gallate (EGCG)-is one of the most commonly used dietary supplements among breast cancer patients. EGCG may alter the metabolism of tamoxifen. Therefore, the aim of this study was to investigate the influence of green tea supplements on the pharmacokinetics of endoxifen; the most relevant active metabolite of tamoxifen.
METHODS


In this single-center, randomized cross-over trial, effects of green tea capsules on endoxifen levels were evaluated. Patients treated with tamoxifen for at least 3 months were eligible for this study. After inclusion, patients were consecutively treated with tamoxifen monotherapy for 28 days and in combination with green tea supplements (1 g twice daily; containing 300 mg EGCG) for 14 days (or vice versa). Blood samples were collected on the last day of monotherapy or combination therapy. Area under the curve (AUC 0-24h ), maximum concentration (C max ) and minimum concentration (C trough ) were obtained from individual plasma concentration-time curves.
RESULTS


No difference was found in geometric mean endoxifen AUC 0-24h  in the period with green tea versus tamoxifen monotherapy (- 0.4%; 95% CI - 8.6 to 8.5%; p = 0.92). Furthermore, no differences in C max  (- 2.8%; - 10.6 to 5.6%; p = 0.47) nor C trough  (1.2%; - 7.3 to 10.5%; p = 0.77) were found. Moreover, no severe toxicity was reported during the whole study period.
CONCLUSIONS


This study demonstrated the absence of a pharmacokinetic interaction between green tea supplements and tamoxifen. Therefore, the use of green tea by patients with tamoxifen does not have to be discouraged.",2020,No difference was found in geometric mean endoxifen AUC 0-24h  in the period with green tea versus tamoxifen monotherapy (- 0.4%; 95% CI - 8.6 to 8.5%; p = 0.92).,"['breast cancer patients treated with', 'breast cancer patients']","['tamoxifen monotherapy', 'EGCG', 'green tea consumption', 'additional herbs or supplements in combination with their anti-cancer therapy', 'green tea capsules', 'green tea supplements (1\xa0g twice daily; containing 300\xa0mg EGCG', 'green tea supplements', 'Green tea-active ingredient epigallocatechin-3-gallate (EGCG)-is', 'tamoxifen']","['metabolism of tamoxifen', 'Area under the curve (AUC 0-24h ), maximum concentration (C max ) and minimum concentration (C trough ', 'severe toxicity', 'endoxifen steady-state concentration', 'C max', 'geometric mean endoxifen AUC', 'endoxifen levels']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1292749', 'cui_str': 'Has active ingredient'}]","[{'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0048311', 'cui_str': '4-hydroxy-N-desmethyltamoxifen'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.137654,No difference was found in geometric mean endoxifen AUC 0-24h  in the period with green tea versus tamoxifen monotherapy (- 0.4%; 95% CI - 8.6 to 8.5%; p = 0.92).,"[{'ForeName': 'C Louwrens', 'Initials': 'CL', 'LastName': 'Braal', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands. c.braal@erasmusmc.nl.'}, {'ForeName': 'Koen G A M', 'Initials': 'KGAM', 'LastName': 'Hussaarts', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Lieke', 'Initials': 'L', 'LastName': 'Seuren', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Oomen-de Hoop', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Bruijn', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Stefan A J', 'Initials': 'SAJ', 'LastName': 'Buck', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Monique E M M', 'Initials': 'MEMM', 'LastName': 'Bos', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Martine F', 'Initials': 'MF', 'LastName': 'Thijs-Visser', 'Affiliation': 'Department of Medical Oncology, Ikazia Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Hanneke J M', 'Initials': 'HJM', 'LastName': 'Zuetenhorst', 'Affiliation': 'Department of Internal Medicine, Franciscus Gasthuis & Vlietland, Schiedam, The Netherlands.'}, {'ForeName': 'Daniëlle', 'Initials': 'D', 'LastName': 'Mathijssen-van Stein', 'Affiliation': 'Department of Internal Medicine, Franciscus Gasthuis & Vlietland, Schiedam, The Netherlands.'}, {'ForeName': 'Mijntje B', 'Initials': 'MB', 'LastName': 'Vastbinder', 'Affiliation': 'Department of Internal Medicine, IJsselland Hospital, Capelle aan den IJssel, The Netherlands.'}, {'ForeName': 'Roelof W F', 'Initials': 'RWF', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'van Gelder', 'Affiliation': 'Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Stijn L W', 'Initials': 'SLW', 'LastName': 'Koolen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Jager', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Ron H J', 'Initials': 'RHJ', 'LastName': 'Mathijssen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05829-6']
1365,32798568,Effect of exercise and grape juice on epigenetic modulation and functional outcomes in PD: A randomized clinical trial.,"OBJECTIVE


This study aimed to investigate the impact of an aquatic physical training program associated with grape juice (Vitis labrusca) consumption on functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels in peripheral blood from individuals with Parkinson's disease.
METHODS


Nineteen participants were randomized to Aquatic Exercise (AQ, n = 9) and Aquatic Exercise + Grape Juice (AQ+GJ, n = 10) groups and performed to 4 weeks of an aquatic intervention (twice a week, approximately 60 min/session). The AQ+GJ groups also consumed 400 mL of grape juice per day during this period. Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS) were evaluated before and after intervention. In addition, blood collections were carried out for biomarker analysis (e.g. BDNF and global histone H4).
RESULTS


The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity. In addition, enhanced levels of BDNF and histone H4 acetylation were found after the intervention. Grape juice consumption did not potentiate these effects, since any significant differences between the AQ and AQ+GJ groups were not found in all analysed variables.
CONCLUSIONS


The present study provides important insights about aquatic exercise-modulated BDNF levels in individuals with Parkinson's disease in combination with functional improvements, suggesting that histone acetylation status may interact to dictate the molecular mechanisms involved in this response. Parkinson disease, aquatic exercise, BDNF, epigenetic, grape juice.",2020,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","['PD', ""individuals with Parkinson's disease"", ""peripheral blood from individuals with Parkinson's disease"", 'Nineteen participants']","['exercise and grape juice', 'AQ+GJ', 'aquatic exercise program', 'aquatic exercise-modulated BDNF levels', 'Aquatic Exercise (AQ, n=9) and Aquatic Exercise\u202f+\u202fGrape Juice (AQ+GJ, n=10) groups and performed to 4 weeks of an aquatic intervention', 'aquatic physical training program associated with grape juice (Vitis labrusca) consumption']","['functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels', 'enhanced levels of BDNF and histone H4 acetylation', 'Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS', 'epigenetic modulation and functional outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452455', 'cui_str': 'Grape juice'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0949819', 'cui_str': 'Vitis'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0019648', 'cui_str': 'Histone H4'}, {'cui': 'C0001038', 'cui_str': 'Acetylation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",19.0,0.0396303,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","[{'ForeName': 'Grazielle Silva De', 'Initials': 'GS', 'LastName': 'Oliveira', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Iraci', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Gislaine Siqueira', 'Initials': 'GS', 'LastName': 'Pinheiro', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Marcela Zimmermann', 'Initials': 'MZ', 'LastName': 'Casal', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Aline Nogueira', 'Initials': 'AN', 'LastName': 'Haas', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pochmann', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil.'}, {'ForeName': 'Flavia Gomes', 'Initials': 'FG', 'LastName': 'Martinez', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Elsner', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil; Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil; Programa de Pós-Graduação em Ciências Biológicas: Fisiologia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dani', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil. Electronic address: carolinedani@yahoo.com.br.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113135']
1366,32798570,Perceptual responses: Clinical versus practical blood flow restriction resistance exercise.,"The purpose of the current investigation was to compare the acute perceptual responses during low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE), to determine if these responses differed between young males and females. Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2  and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design: 1) cBFR-RE, 2) pBFR-RE, 3) HL-RE, and 4) LL-RE. Low-load conditions consisted of 30-15-15-15 repetitions of two-leg press (LP) and knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE consisted of 3 sets of 10 repetitions at 80% 1-RM, all with 60s rest intervals. Ratings of perceived exertion (RPE) and discomfort were assessed before exercise and immediately following each set. RPE was significantly higher in HL-RE compared to all low-load conditions for both exercises after each set (all p<0.05). cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05). Levels of discomfort were similar between cBFR-RE and HL-RE, which tended to be significantly higher than pBFR-RE and LL-RE (p<0.05). Men reported significantly greater RPE than women following sets 2-4 during KE with cBFR-RE and sets 2 and 3 during KE for HL-RE (all p<0.05). Males also reported significantly greater discomfort than women following sets 2-4 for KE LL-RE (p<0.05). Altogether, these data suggest that pBFR-RE may provide a more favorable BFR condition based on perceptual responses and that perceptual responses may differ between sexes across varying resistance exercise conditions.",2020,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"['Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2  and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design', 'young males and females']","['low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE', 'knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE']","['Levels of discomfort', 'Ratings of perceived exertion (RPE) and discomfort', 'acute perceptual responses', 'discomfort', 'RPE']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",,0.0352726,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"[{'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Miller', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA. Electronic address: ryanmiller1@ou.edu.'}, {'ForeName': 'Bianca A R', 'Initials': 'BAR', 'LastName': 'Galletti', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Karolina J', 'Initials': 'KJ', 'LastName': 'Koziol', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Eduardo D S', 'Initials': 'EDS', 'LastName': 'Freitas', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Heishman', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA; Department of Athletics, Basketball Strength and Performance, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Black', 'Affiliation': 'Department of Health and Exercise Science, Sensory and Muscle Function Research Laboratory, University of Oklahoma, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Larson', 'Affiliation': 'Departmeny of Health and Exercise Science, Sport, Health, and Exercise Data Analytics Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Bemben', 'Affiliation': 'Departmeny of Health and Exercise Science, Bone Density Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Bemben', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113137']
1367,32798588,Anti-erosive effect of rinsing before or after toothbrushing with a Fluoride/Stannous Ions solution: an in situ investigation: Application order of Fluoride/Tin products for erosive tooth wear.,"OBJECTIVE


To evaluate the impact of the application of a F - /Sn 2+ -containing mouthrinse before or after toothbrushing with a F - /Sn 2+ /chitosan toothpaste on the progression of erosion/abrasion on enamel and dentin.
METHODS


This crossover in situ study had five arms: Control (toothbrushing without toothpaste), Brushing (toothbrushing with toothpaste), Brushing + Rinsing, Rinsing + Brushing, and Rinsing (without toothbrushing). Fifteen subjects used removable mandibular appliances containing 3 enamel and 3 dentin specimens, which were subjected to erosion-abrasion cycling of 60 min salivary pellicle formation followed by 5 min extra-oral erosion with 1% citric acid (4x/day for 5 days). Treatments were performed in situ after first and last erosive challenges with rinse (10 ml; 30 s) and/or toothbrushing with/without toothpaste (with electric toothbrush; 5 s per specimen; total 2 min contact with slurry). Surface loss (SL) was evaluated with an optical profilometer. Data were analyzed by two-way repeated measures ANOVA and Tukey tests (α = 0.05).
RESULTS


The Control showed the highest SL (mean ± SD for enamel: 24.58 ± 11.32; dentin: 32.32 ± 10.10; all μm). Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing. None of the arms that underwent toothbrushing with the toothpaste differed from each other (p > 0.05). Dentin specimens showed significantly higher SL values than enamel (p < 0.001).
CONCLUSION


The order of treatment applications had no influence on their anti-erosive effect; however, toothbrushing with F - /Sn 2+ /chitosan toothpaste reduced enamel surface loss. Additional rinsing with F - /Sn 2+  mouthrinse did not offer improved protection.
CLINICAL SIGNIFICANCE


The use of fluoride- and stannous- containing toothpastes and mouthrinses is an important approach in the prevention of erosive tooth wear. Further evidence is needed to support the benefit of combining these products against this condition.",2020,"Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing.","['Fifteen subjects used removable mandibular appliances containing 3 enamel and 3 dentin specimens, which were subjected to']","['Rinsing', 'erosion-abrasion cycling of 60\u2009min salivary pellicle formation followed by 5\u2009min extra-oral erosion with 1% citric acid', 'fluoride- and stannous- containing toothpastes and mouthrinses', 'Fluoride/stannous Ions Solution', 'F-/Sn2+/chitosan toothpaste', 'F-/Sn2+ mouthrinse', 'Fluoride/Tin products', 'Control (toothbrushing without toothpaste), Brushing (toothbrushing with toothpaste), Brushing\u2009+\u2009Rinsing, Rinsing\u2009+\u2009Brushing, and Rinsing (without toothbrushing', 'toothbrushing with/without toothpaste (with electric toothbrush; 5\u2009s per specimen; total 2\u2009min contact with slurry', 'F-/Sn2+-containing mouthrinse']","['Surface loss (SL', 'progression of erosion/abrasion on enamel and dentin', 'protection', 'enamel surface loss', 'SL values', 'SL value']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C1292488', 'cui_str': 'Dentin specimen'}]","[{'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1257926', 'cui_str': 'Salivary Acquired Pellicle'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0040238', 'cui_str': 'Tin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0225144,"Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing.","[{'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Machado', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: alanam@usp.br.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Sakae', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: leticia.sakae@usp.br.'}, {'ForeName': 'Samira Helena', 'Initials': 'SH', 'LastName': 'Niemeyer', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Freiburgstrasse 7 CH-3010, Bern, Switzerland. Electronic address: samira.joaosouza@gmail.com.'}, {'ForeName': 'Thiago Saads', 'Initials': 'TS', 'LastName': 'Carvalho', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Freiburgstrasse 7 CH-3010, Bern, Switzerland. Electronic address: thiago.saads@zmk.univbe.ch.'}, {'ForeName': 'Bennett', 'Initials': 'B', 'LastName': 'Amaechi', 'Affiliation': 'Department of Comprehensive Dentistry, University of Texas Health Science Center of San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States. Electronic address: amaechi@uthscsa.edu.'}, {'ForeName': 'Taís', 'Initials': 'T', 'LastName': 'Scaramucci', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: tais.sca@usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103450']
1368,32805205,"Lubiprostone in patients with non-alcoholic fatty liver disease: a randomised, double-blind, placebo-controlled, phase 2a trial.","BACKGROUND


The laxative drug lubiprostone improves intestinal permeability in healthy volunteers. We aimed to assess efficacy and safety of lubiprostone in patients with non-alcoholic fatty liver disease (NAFLD) with constipation via attenuation of intestinal permeability.
METHODS


This randomised, double-blind, placebo-controlled, phase 2a study in Yokohama City University Hospital, Japan, recruited patients (aged 20-85 years) with NAFLD and constipation, alanine aminotransferase (ALT) at least 40 U/L, liver stiffness (≤6·7 kPa), and hepatic fat fraction at least 5·2% when assessed by MRI-proton density fat fraction. Eligible patients were randomly assigned (11:10:9) by a computer-based system and stratified by age and sex to receive 24 μg lubiprostone, 12 μg lubiprostone, or placebo, orally, once per day for 12 weeks. The primary endpoint was the absolute changes in ALT at 12 weeks. Efficacy analysis was done by intention to treat. Safety was assessed in all treated patients. This trial was registered with University Hospital Medical Information Network Clinical Trials Registry (UMIN000026635).
FINDINGS


Between March 24, 2017, and April 3, 2018, we screened 288 patients, of whom 150 (52%) were randomly assigned to treatment: 55 patients were assigned to receive 24 μg lubiprostone, 50 to receive 12 μg lubiprostone, and 45 to receive placebo. A greater decrease in the absolute ALT levels from baseline to 12 weeks was seen in the 24 μg lubiprostone group (mean -13 U/L [SD 19]) than in the placebo group (1 U/L [24]; mean difference -15 U/L [95% CI -23 to -6], p=0·0007) and in the 12 μg lubiprostone group (-12 U/L [21]) than in the placebo group (mean difference -13 U/L [-22 to -5], p=0·0023). 18 (33%) of 55 patients in the 24 μg group had at least one adverse event, as did three (6%) of 47 patients in the 12 μg group and three (7%) of 43 in the placebo group. The most common adverse event was diarrhoea (17 [31%] of patients in the 24 μg group, three [6%] in the 12 μg group, none in the placebo group). No life-threatening events or treatment-related deaths occurred.
INTERPRETATION


Lubiprostone was well tolerated and reduced the levels of liver enzymes in patients with NAFLD and constipation. Further studies are necessary to better define the efficacy and tolerability of lubiprostone in patients with NAFLD without constipation.
FUNDING


Mylan EPD G.K.",2020,"No life-threatening events or treatment-related deaths occurred.
","['288 patients, of whom 150 (52%) were randomly assigned to treatment: 55 patients', 'healthy volunteers', 'patients with NAFLD without constipation', 'Yokohama City University Hospital, Japan, recruited patients (aged 20-85 years) with NAFLD and constipation, alanine aminotransferase (ALT', 'patients with non-alcoholic fatty liver disease', 'patients with non-alcoholic fatty liver disease (NAFLD) with constipation via attenuation of intestinal permeability', 'Between March 24, 2017, and April 3, 2018', 'patients with NAFLD and constipation', 'Eligible patients']","['computer-based system and stratified by age and sex to receive 24 μg lubiprostone, 12 μg lubiprostone, or placebo', 'U/L', 'Lubiprostone', 'laxative drug lubiprostone', '24 μg lubiprostone, 50 to receive 12 μg lubiprostone, and 45 to receive placebo', 'lubiprostone', 'placebo']","['absolute ALT levels', 'Safety', 'intestinal permeability', 'diarrhoea', 'adverse event', 'efficacy and tolerability', 'efficacy and safety', 'absolute changes in ALT', 'levels of liver enzymes', 'liver stiffness (≤6·7 kPa), and hepatic fat fraction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1684405', 'cui_str': 'lubiprostone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C0282090', 'cui_str': 'Laxative'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0263428', 'cui_str': 'Ulerythema ophryogenes'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",55.0,0.708799,"No life-threatening events or treatment-related deaths occurred.
","[{'ForeName': 'Takaomi', 'Initials': 'T', 'LastName': 'Kessoku', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Palliative Medicine, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Kento', 'Initials': 'K', 'LastName': 'Imajo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ozaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Iwaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Honda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Palliative Medicine, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Gastroenterology, International University of Health and Welfare Atami Hospital, Atami, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Tomeno', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Gastroenterology, International University of Health and Welfare Atami Hospital, Atami, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Higurashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Yoneda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kirikoshi', 'Affiliation': 'Clinical Laboratory Department, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Taguri', 'Affiliation': 'Department of Data Science, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Usuda', 'Affiliation': 'Department of Pharmacology, Shimane University Faculty of Medicine, Izumo, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Wada', 'Affiliation': 'Department of Pharmacology, Shimane University Faculty of Medicine, Izumo, Japan.'}, {'ForeName': 'Noritoshi', 'Initials': 'N', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Oncology, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakajima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan. Electronic address: nakajima-tky@umin.ac.jp.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30216-8']
1369,32805259,Neonatal Abstinence Syndrome Severity Index Predicts 18-Month Neurodevelopmental Outcome in Neonates Randomized to Morphine or Methadone.,"OBJECTIVE


To develop an index to determine which opioid-exposed neonates have the most severe neonatal abstinence syndrome (NAS).
STUDY DESIGN


Full-term neonates with NAS (n = 116) from mothers maintained on methadone or buprenorphine were enrolled from 8 sites into a randomized clinical trial of morphine vs methadone. Ninety-nine (85%) were evaluated at hospital discharge using the NICU Network Neurobehavioral Scale (NNNS). At 18 months, 83 of 99 (83.8%) were evaluated with the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), and 77 of 99 (77.7%) were evaluated with the Child Behavior Checklist (CBCL).
RESULTS


Cluster analysis was used to define high (n = 21) and low (n = 77) NAS severity. Compared with infants in the low NAS severity cluster, infants in the high NAS severity cluster had a longer length of stay (P < .001), longer length of stay due to NAS (P < .001), longer duration of treatment due to NAS (P < .001), and higher total dose of the study drug (P < .001) and were more likely to have received phenobarbital (P < .001), to have been treated with morphine (P = .020), and to have an atypical NNNS profile (P = .005). The 2 groups did not differ in terms of maximum Finnegan score. At 18 months, in unadjusted analyses, compared with the high-severity cluster, the low-severity cluster had higher scores on the Bayley-III Cognitive (P = .013), Language (P < .001), and Motor (P = .041) composites and less total behavior problems on the CBCL (P = .028). In adjusted analyses, the difference in the Bayley-III Language composite remained (P = .013).
CONCLUSIONS


Presumptive measures of NAS severity can be aggregated to develop an index that predicts developmental outcomes at age 18 months.",2020,"Infants in the high NAS severity cluster had a longer length of stay (P<.001), longer length of stay due to NAS (P < .001), longer length of treatment due to NAS (P<.001), higher total dose of study drug (P<.001), were more likely to have received phenobarbital (P<.001), be treated with morphine (P=.020) and have an atypical NNNS profile (P=.005) than infants in the low NAS severity group.",['Full-term neonates with NAS (n=116) from mothers maintained on'],"['morphine vs methadone', 'Morphine or Methadone', 'morphine', 'methadone or buprenorphine']","['longer length of treatment due to NAS', 'Neonatal Abstinence Syndrome Severity Index Predicts', 'maximum Finnegan score', 'Bayley-III Cognitive (P=.013), Language (P<.001) and Motor (P=.041) Composites and less total behavior problems', 'Bayley Scales of Infant and Toddler Development-Third Edition', 'longer length of stay', 'Language Composite', 'hospital discharge using the NICU Network Neurobehavioral Scale (NNNS', 'Child Behavior Checklist (CBCL', 'longer length of stay due to NAS']","[{'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0027609', 'cui_str': 'Neonatal Abstinence Syndrome'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0027609', 'cui_str': 'Neonatal Abstinence Syndrome'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",,0.126136,"Infants in the high NAS severity cluster had a longer length of stay (P<.001), longer length of stay due to NAS (P < .001), longer length of treatment due to NAS (P<.001), higher total dose of study drug (P<.001), were more likely to have received phenobarbital (P<.001), be treated with morphine (P=.020) and have an atypical NNNS profile (P=.005) than infants in the low NAS severity group.","[{'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Flannery', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Department of Pediatrics, The Floating Hospital for Children at Tufts Medical Center, Boston, MA; Tufts Clinical and Translational Science Institute, Boston, MA; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Czynski', 'Affiliation': 'Department of Pediatrics, Warren Alpert Medical School of Brown University and Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Dansereau', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Oliveira', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Samantha A', 'Initials': 'SA', 'LastName': 'Camardo', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Barry M', 'Initials': 'BM', 'LastName': 'Lester', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI; Department of Pediatrics, Warren Alpert Medical School of Brown University and Women and Infants Hospital, Providence, RI; Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI. Electronic address: Barry_Lester@Brown.edu.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.08.034']
1370,32824040,Interactive Low Back Pain Intervention Module Based on the Back School Program: A Cluster-Randomized Experimental Study Evaluating Its Effectiveness among Nurses in Public Hospitals.,"The prevalence of low back pain (LBP) among nurses is high. The main aim of this study was to evaluate the effectiveness of an interactive LBP module based on the Back School Program in improving Oswestry Disability Scores (ODSs) among nurses in government hospitals in Penang, Malaysia. A cluster-randomized experimental study was conducted within four public hospitals. These hospitals were randomized to intervention and control groups. A total of 284 nurses from the selected hospitals were randomly selected (142 in each group). An interactive LBP intervention module based on the Back School Program was designed and prescribed. Both the intervention and control groups were assessed using the Oswestry Disability Questionnaire at baseline and at the end of the third and sixth weeks. Out of 284 participants, 281 completed this study. A between-group comparison revealed that ODSs were significantly lower in the intervention group than in the control group at the ends of the third ( p  = 0.006) and sixth weeks ( p  < 0.001). Within-group changes revealed a significant reduction in ODSs within the intervention group from baseline to the third ( p  < 0.001) and sixth weeks ( p  < 0.001) of the intervention. This simple interactive LBP module was effective in reducing symptoms of LBP among nurses as early as three weeks, and this effect was sustained until the sixth week of the intervention.",2020,"This simple interactive LBP module was effective in reducing symptoms of LBP among nurses as early as three weeks, and this effect was sustained until the sixth week of the intervention.","['Back School Program', 'nurses in government hospitals in Penang, Malaysia', 'four public hospitals', '284 nurses from the selected hospitals were randomly selected (142 in each group', '284 participants, 281 completed this study', 'Nurses in Public Hospitals']","['Interactive Low Back Pain Intervention Module', 'interactive LBP module based on the Back School Program']","['Oswestry Disability Scores (ODSs', 'Oswestry Disability Questionnaire', 'ODSs', 'low back pain (LBP']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0337960', 'cui_str': 'Government hospital'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]",284.0,0.0391314,"This simple interactive LBP module was effective in reducing symptoms of LBP among nurses as early as three weeks, and this effect was sustained until the sixth week of the intervention.","[{'ForeName': 'Mohd Ismail', 'Initials': 'MI', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Community Medicine, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kubang Kerian, Kelantan 16150, Malaysia.'}, {'ForeName': 'Izani Uzair', 'Initials': 'IU', 'LastName': 'Zubair', 'Affiliation': 'Penang Health State Department, 33 Pengkalan Weld, George Town, Penang 10300, Malaysia.'}, {'ForeName': 'Mohd Nazri', 'Initials': 'MN', 'LastName': 'Shafei', 'Affiliation': 'Department of Community Medicine, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kubang Kerian, Kelantan 16150, Malaysia.'}, {'ForeName': 'Mohd Izmi', 'Initials': 'MI', 'LastName': 'Ahmad', 'Affiliation': 'Hospital Pulau Pinang, Jalan Residensi, George Town, Penang 10990, Malaysia.'}, {'ForeName': 'Najib Majdi', 'Initials': 'NM', 'LastName': 'Yaacob', 'Affiliation': 'Units of Biostatistics and Research Methodology, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kubang Kerian, Kelantan 16150, Malaysia.'}]",International journal of environmental research and public health,['10.3390/ijerph17165916']
1371,32827953,The strap intermuscular approach can significantly increase the exposure rate of the external branch of the superior laryngeal nerve during thyroid surgery.,"BACKGROUND


Avoiding injury to the external branch of the superior laryngeal nerve (EBSLN) is a major challenge during thyroid surgery. EBSLN injury can have an impact on the quality of life of patients. The aim of this study was to introduce the strap intermuscular approach, to dissect the EBSLN with two different approaches in thyroid surgery, to compare the differences between these two approaches, and to describe a way for surgeons to treat the upper thyroid gland to find the EBSLN.
METHODS


A prospective study of hemithyroidectomy was performed. In total, 104 patients were included and randomly divided into two groups: one group used the traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach. We described the surgical procedure for the strap intermuscular approach and compared the differences in the rates of EBSLN exposure, injury, and classification to illustrate the advantages of the intermuscular approach in thyroid surgery.
RESULTS


The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630). The exposure rate of EBSLNs classified as type 1 was higher in the strap intermuscular approach than in the traditional approach (30.77% vs. 13.46%, p = 0.033), with an OR and 95% CI of 0.350 (0.130-0.942).
CONCLUSIONS


The exposure rate of the EBSLN was significantly higher with the strap intermuscular approach method than with the traditional approach during thyroid surgery. This approach allows for better identification of the EBSLN during thyroidectomy.",2020,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).",['104 patients'],"['traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach', 'hemithyroidectomy']",['exposure rate of the EBSLN'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183631', 'cui_str': 'Strap'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}]",104.0,0.0387604,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Hei', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Songtao', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chuang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Runfang', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Jianwu', 'Initials': 'J', 'LastName': 'Qin', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. Electronic address: qinjianwu_62@163.com.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.004']
1372,32833128,Influence of Prenatal Aerobic Exercise on Fetal Morphometry.,"OBJECTIVE


The purpose of this study was to determine the effects of supervised prenatal aerobic exercise on fetal morphometrics at 36 weeks of gestation.
METHODS


This study used data from a, 24-week, two-arm randomized controlled trial: aerobic exercise (EX) and stretching/breathing comparison group (CON). Singleton pregnancies (< 16 weeks pregnant) and women aged 18 to 40 years, BMI between 18.5 and 34.99 kg/m 2 , and no preexisting chronic health conditions were eligible. The EX group participated in 150 min of moderate-intensity weekly exercise while CON group participated in low-intensity stretching/breathing. Fetal morphometric outcomes included estimated fetal weight (EFW), ponderal index (PI), abdominal circumference (AC), anterior abdominal wall thickness (AAWT), fat mass, percent body fat, fat-free mass, assessed at 36 weeks gestation. Partial spearman rank correlations were performed, adjusting for 3 rd  trimester weight gain.
RESULTS


Of the 128 pregnant women randomized, 83 (EX [n = 46] and CON [n = 37]) were eligible for analyses. Intention-to-treat analysis showed no differences in EFW (rho s  = - 0.13; p = 0.28), PI (rho s  = 0.03; p = 0.81), AC (rho s  = - 0.22; p = 0.09), AAWT (rho s  = - 0.11; p = 0.40), fat mass (rho s  = - 0.16; p = 0.23), percent body fat (rho s  = - 0.10; p = 0.43), and fat-free mass (rho s  = - 0.22; p = 0.08), after adjusting for 3rd trimester weight gain. Similar results were observed in the per protocol analyses.
CONCLUSIONS


For Practice Moderate-intensity aerobic exercise during pregnancy was not associated with select fetal morphometrics at 36 weeks gestation. Potential differences in offspring morphometrics may only appear in the postnatal period, as previously documented. Further research into offspring tissue composition after birth is encouraged, specifically studies investigating differences in cellular signaling pathways related to adipose and skeletal muscle tissue development.",2020,"Intention-to-treat analysis showed no differences in EFW (rho s  = - 0.13; p = 0.28), PI (","['128 pregnant women randomized, 83 (EX [n\u2009=\u200946] and CON [n\u2009=\u200937]) were eligible for analyses', 'Singleton pregnancies (<\u200916\xa0weeks pregnant) and women aged 18 to 40\xa0years, BMI between 18.5 and 34.99\xa0kg/m 2 , and no preexisting chronic health conditions were eligible']","['supervised prenatal aerobic exercise', 'moderate-intensity weekly exercise while CON group participated in low-intensity stretching/breathing', 'aerobic exercise (EX) and stretching/breathing comparison group (CON', 'Prenatal Aerobic Exercise']","['EFW', 'Fetal Morphometry', 'fat mass', 'fetal morphometrics', 'percent body fat', 'estimated fetal weight (EFW), ponderal index (PI), abdominal circumference (AC), anterior abdominal wall thickness (AAWT), fat mass, percent body fat, fat-free mass']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0460089', 'cui_str': 'Finding of length of gestation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0751992', 'cui_str': 'Body Weight, Fetal'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0200760', 'cui_str': 'Morphometric analysis'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0424670', 'cui_str': 'Weight for height'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0230193', 'cui_str': 'Anterior abdominal wall structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0836916', 'cui_str': 'Abdominal wall structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}]",128.0,0.191963,"Intention-to-treat analysis showed no differences in EFW (rho s  = - 0.13; p = 0.28), PI (","[{'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'McDonald', 'Affiliation': 'Department of Foundational Science and Research, ECU, 1851 MacGregor Downs Rd, Greenville, NC, 27834, USA.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Newton', 'Affiliation': 'Department of Obstetrics and Gynecology, ECU, Greenville, NC, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Strickland', 'Affiliation': 'Department of Obstetrics and Gynecology, ECU, Greenville, NC, USA.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Isler', 'Affiliation': 'Department of Obstetrics and Gynecology, ECU, Greenville, NC, USA.'}, {'ForeName': 'Kelley', 'Initials': 'K', 'LastName': 'Haven', 'Affiliation': 'Department of Obstetrics and Gynecology, ECU, Greenville, NC, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Kelley', 'Affiliation': 'Department of Biostatistics, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Chasan-Taber', 'Affiliation': 'Department of Biostatistics & Epidemiology, University of Massachusetts, Amherst, MA, USA.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Kuehn', 'Affiliation': 'Department of Clinical Pediatrics, ECU, Greenville, NC, USA.'}, {'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'May', 'Affiliation': 'Department of Foundational Science and Research, ECU, 1851 MacGregor Downs Rd, Greenville, NC, 27834, USA. mayl@ecu.edu.'}]",Maternal and child health journal,['10.1007/s10995-020-03000-7']
1373,32809261,Serum potassium in the PARADIGM-HF trial.,"AIMS


The associations between potassium level and outcomes, the effect of sacubitril-valsartan on potassium level, and whether potassium level modified the effect of sacubitril-valsartan in patients with heart failure and a reduced ejection fraction were studied in PARADIGM-HF. Several outcomes, including cardiovascular death, sudden death, pump failure death, non-cardiovascular death and heart failure hospitalization, were examined.
METHODS AND RESULTS


A total of 8399 patients were randomized to either enalapril or sacubitril-valsartan. Potassium level at randomization and follow-up was examined as a continuous and categorical variable (≤3.5, 3.6-4.0, 4.1-4.9, 5.0-5.4 and ≥5.5 mmol/L) in various statistical models. Hyperkalaemia was defined as K +   ≥5.5 mmol/L and hypokalaemia as K +   ≤3.5 mmol/L. Compared with potassium 4.1-4.9 mmol/L, both hypokalaemia [hazard ratio (HR) 2.40, 95% confidence interval (CI) 1.84-3.14] and hyperkalaemia (HR 1.42, 95% CI 1.10-1.83) were associated with a higher risk for cardiovascular death. However, potassium abnormalities were similarly associated with sudden death and pump failure death, as well as non-cardiovascular death and heart failure hospitalization. Sacubitril-valsartan had no effect on potassium overall. The benefit of sacubitril-valsartan over enalapril was consistent across the range of baseline potassium levels.
CONCLUSIONS


Although both higher and lower potassium levels were independent predictors of cardiovascular death, potassium abnormalities may mainly be markers rather than mediators of risk for death.",2020,"However, potassium abnormalities were similarly associated with sudden death and pump failure death, as well as non-cardiovascular death and heart failure hospitalization.","['patients with heart failure and a reduced ejection fraction in PARADIGM-HF', '8399 patients']","['Sacubitril/valsartan', 'sacubitril/valsartan', 'enalapril', 'enalapril or sacubitril/valsartan', 'Potassium']","['non-cardiovascular death and heart failure hospitalization', 'Hyperkalemia', 'hyperkalemia', 'hypokalemia', 'cardiovascular death, sudden-death, pump-failure death, non-cardiovascular death and heart failure hospitalization', 'potassium overall', 'sudden death and pump failure death', 'Serum Potassium', 'risk of cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",8399.0,0.162291,"However, potassium abnormalities were similarly associated with sudden death and pump failure death, as well as non-cardiovascular death and heart failure hospitalization.","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'National Institute of Health and Medical Research, Centre for Clinical Multidisciplinary Research, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Nancy, France.'}, {'ForeName': 'Ulrik M', 'Initials': 'UM', 'LastName': 'Mogensen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jean-Lucien', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Heart Institute, Montreal, QC, Canada.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina and Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': 'National Institute of Health and Medical Research, Centre for Clinical Multidisciplinary Research, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Nancy, France.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'National Institute of Health and Medical Research, Centre for Clinical Multidisciplinary Research, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Nancy, France.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}]",European journal of heart failure,['10.1002/ejhf.1987']
1374,32806584,Stopping the Drop: Examining the Impact of a Pilot Physical Literacy-Based Intervention Program on Physical Activity Behaviours and Fitness during the Transition into University.,"The move to university is a major life transition associated with precipitous declines in physical activity (PA). While it remains unclear how these declines can be best attenuated, the concept of physical literacy (PL) or enhancements of PL may be a promising modality to promote PA during life transitions. The purpose of the current study was to evaluate the impact of a pilot PL-based intervention on PA and fitness for students transitioning into university. Participants included 65 first-year students ( M age  = 17.85 ± 0.51;  n  = 46 females), enrolled in a quasi-experimental study. Intervention participants ( n  = 26) participated in a 12-week novel movement skills program conducted in a group-based environment. Results from the 2 × 2 repeated measures ANOVA found moderate effects in the time by condition interaction  F (1,56) = 2.70,  p  = 0.11, η p 2  = 0.08 for PA behaviors as well as for estimated cardiorespiratory fitness  F (1,61) = 8.35,  p  = 0.005, η p 2  = 0.12. Findings from our pilot program suggest that PL may be an effective modality to help first-year university students maintain fitness and attenuate the declines in PA behaviors when transitioning into university. Similar trials with larger samples are required.",2020,Findings from our pilot program suggest that PL may be an effective modality to help first-year university students maintain fitness and attenuate the declines in PA behaviors when transitioning into university.,"['Participants included 65 first-year students ( M age  = 17.85 ± 0.51;  n  = 46 females), enrolled in a quasi-experimental study', 'Intervention participants ( n  = 26) participated in a 12-week', 'students transitioning into university']","['novel movement skills program conducted in a group-based environment', 'Pilot Physical Literacy-Based Intervention Program', 'pilot PL-based intervention']",['PA behaviors'],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",65.0,0.0154813,Findings from our pilot program suggest that PL may be an effective modality to help first-year university students maintain fitness and attenuate the declines in PA behaviors when transitioning into university.,"[{'ForeName': 'Matthew Y W', 'Initials': 'MYW', 'LastName': 'Kwan', 'Affiliation': 'Department of Family Medicine, David Braley Health Sciences Centre, McMaster University, 100 Main St W, 5th Floor Research, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Graham', 'Affiliation': 'Department of Family Medicine, David Braley Health Sciences Centre, McMaster University, 100 Main St W, 5th Floor Research, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Cierra', 'Initials': 'C', 'LastName': 'Healey', 'Affiliation': 'Department of Family Medicine, David Braley Health Sciences Centre, McMaster University, 100 Main St W, 5th Floor Research, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Paolucci', 'Affiliation': 'Department of Family Medicine, David Braley Health Sciences Centre, McMaster University, 100 Main St W, 5th Floor Research, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Denver M', 'Initials': 'DM', 'LastName': 'Brown', 'Affiliation': 'Department of Family Medicine, David Braley Health Sciences Centre, McMaster University, 100 Main St W, 5th Floor Research, Hamilton, ON L8S 4K1, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17165832']
1375,32812025,"Evaluation of the efficacy of sofosbuvir plus daclatasvir in combination with ribavirin for hospitalized COVID-19 patients with moderate disease compared with standard care: a single-centre, randomized controlled trial.","BACKGROUND


New therapeutic options are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). Repurposing existing pharmaceuticals provides an immediate treatment opportunity. We assessed the efficacy of sofosbuvir and daclatasvir with ribavirin for treating patients with COVID-19.
METHODS


This was a single-centre, randomized controlled trial in adults with moderate COVID-19 admitted to the Ghaem Shahr Razi Hospital in Mazandaran Province, Iran. Patients were randomly assigned to 400 mg sofosbuvir, 60 mg daclatasvir and 1200 mg ribavirin (intervention group) or to standard care (control group). The primary endpoint of this study was length of hospital stay. This study is registered by IRCT.ir under the ID: IRCT20200328046886N1.
RESULTS


Between 20 March 2020 and 8 April 2020, 48 patients were recruited; 24 patients were randomly assigned to the intervention group and 24 to the control group. The median duration of hospital stay was 6 days in both groups (P = 0.398). The number of ICU admissions in the sofosbuvir/daclatasvir/ribavirin group was not significantly lower than the control group (0 versus 4, P = 0.109). There was no difference in the number of deaths between the groups (0 versus 3, P = 0.234). The cumulative incidence of recovery was higher in the sofosbuvir/daclatasvir/ribavirin arm (Gray's P = 0.033).
CONCLUSIONS


This randomized trial was too small to make definitive conclusions. There were trends in favour of the sofosbuvir/daclatasvir/ribavirin arm for recovery and lower death rates. However, there was an imbalance in the baseline characteristics between the arms. Larger randomized trials should be conducted to investigate this treatment further.",2020,"There was no difference in the number of deaths between the groups (0 versus 3, P = 0.234).","['adults with moderate COVID-19 admitted to the Ghaem Shahr Razi Hospital in Mazandaran Province, Iran', 'hospitalized COVID-19 patients with moderate disease compared with standard care', 'treating patients with COVID-19', 'Between 20 March 2020 and 8 April 2020, 48 patients were recruited; 24 patients']","['sofosbuvir plus daclatasvir', 'daclatasvir and 1200\u2009mg ribavirin (intervention group) or to standard care (control group', 'ribavirin']","['median duration of hospital stay', 'recovery and lower death rates', 'number of ICU admissions', 'length of hospital stay', 'number of deaths', 'cumulative incidence of recovery']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",48.0,0.112652,"There was no difference in the number of deaths between the groups (0 versus 3, P = 0.234).","[{'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Abbaspour Kasgari', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Siavash', 'Initials': 'S', 'LastName': 'Moradi', 'Affiliation': 'Education Development Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Amir Mohammad', 'Initials': 'AM', 'LastName': 'Shabani', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Farhang', 'Initials': 'F', 'LastName': 'Babamahmoodi', 'Affiliation': 'Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Davoudi Badabi', 'Affiliation': 'Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Lotfollah', 'Initials': 'L', 'LastName': 'Davoudi', 'Affiliation': 'Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alikhani', 'Affiliation': 'Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Hedayatizadeh Omran', 'Affiliation': 'Gastrointestinal Cancer Research Center, Cancer Research Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Saeedi', 'Affiliation': 'Pharmaceutical Sciences Research Center, Hemoglobinopathy Research Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Merat', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Wentzel', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Garratt', 'Affiliation': 'Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Levi', 'Affiliation': 'Accident and Emergency Department, Homerton University Hospital NHS Trust, London, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Simmons', 'Affiliation': 'Department of Infectious Disease, Imperial College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Department of Translational Medicine, University of Liverpool, UK.'}, {'ForeName': 'Hafez', 'Initials': 'H', 'LastName': 'Tirgar Fakheri', 'Affiliation': 'Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa332']
1376,32812039,Sofosbuvir and daclatasvir compared with standard of care in the treatment of patients admitted to hospital with moderate or severe coronavirus infection (COVID-19): a randomized controlled trial.,"BACKGROUND


Currently no effective antiviral therapy has been found to treat COVID-19. The aim of this trial was to assess if the addition of sofosbuvir and daclatasvir improved clinical outcomes in patients with moderate or severe COVID-19.
METHODS


This was an open-label, multicentre, randomized controlled clinical trial in adults with moderate or severe COVID-19 admitted to four university hospitals in Iran. Patients were randomized into a treatment arm receiving sofosbuvir and daclatasvir plus standard care, or a control arm receiving standard care alone. The primary endpoint was clinical recovery within 14 days of treatment. The study is registered with IRCT.ir under registration number IRCT20200128046294N2.
RESULTS


Between 26 March and 26 April 2020, 66 patients were recruited and allocated to either the treatment arm (n = 33) or the control arm (n = 33). Clinical recovery within 14 days was achieved by 29/33 (88%) in the treatment arm and 22/33 (67%) in the control arm (P = 0.076). The treatment arm had a significantly shorter median duration of hospitalization [6 days (IQR 4-8)] than the control group [8 days (IQR 5-13)]; P = 0.029. Cumulative incidence of hospital discharge was significantly higher in the treatment arm versus the control (Gray's P = 0.041). Three patients died in the treatment arm and five in the control arm. No serious adverse events were reported.
CONCLUSIONS


The addition of sofosbuvir and daclatasvir to standard care significantly reduced the duration of hospital stay compared with standard care alone. Although fewer deaths were observed in the treatment arm, this was not statistically significant. Conducting larger scale trials seems prudent.",2020,The addition of sofosbuvir and daclatasvir to standard care significantly reduced the duration of hospital stay compared with standard care alone.,"['adults with moderate or severe COVID-19 admitted to four university hospitals in Iran', 'patients admitted to hospital with moderate or severe coronavirus infection (COVID-19', '66 patients', 'Between 26 March and 26 April 2020', 'patients with moderate or severe COVID-19']","['sofosbuvir and daclatasvir plus standard care, or a control arm receiving standard care alone', 'Sofosbuvir and daclatasvir']","['median duration of hospitalization', 'duration of hospital stay', 'Clinical recovery', 'serious adverse events', 'deaths', 'clinical recovery', 'Cumulative incidence of hospital discharge']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206750', 'cui_str': 'Coronavirus infection'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",66.0,0.111872,The addition of sofosbuvir and daclatasvir to standard care significantly reduced the duration of hospital stay compared with standard care alone.,"[{'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ali Asgari', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Norouzi', 'Affiliation': 'Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Science, Gorgan, Iran.'}, {'ForeName': 'Zahedin', 'Initials': 'Z', 'LastName': 'Kheiri', 'Affiliation': 'Department of Internal Medicine, Baharloo hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Anushirvani', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Montazeri', 'Affiliation': 'Department of infectious diseases, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hadiseh', 'Initials': 'H', 'LastName': 'Hosamirudsai', 'Affiliation': 'Department of Infectious Diseases, Baharloo Hospital, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Afhami', 'Affiliation': 'Department of infectious diseases, Shariati Hospital, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Akbarpour', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Rasoul', 'Initials': 'R', 'LastName': 'Aliannejad', 'Affiliation': 'Department of Pulmonary and Critical Care, Shariati Hospital, Thoracic Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Reza', 'Initials': 'AR', 'LastName': 'Radmard', 'Affiliation': 'Department of Radiology, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Davarpanah', 'Affiliation': 'Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Levi', 'Affiliation': 'Department of Emergency Medicine, Homerton University Hospital, London, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Wentzel', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Ambar', 'Initials': 'A', 'LastName': 'Qavi', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Garratt', 'Affiliation': 'Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Simmons', 'Affiliation': 'Department of Infectious Disease, Imperial College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Merat', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa334']
1377,32813928,Can abdominal hypropressive technique improve stress urinary incontinence? an assessor-blinded randomized controlled trial.,"AIM


To verify which one improves better stress urinary incontinence (SUI) symptoms: abdominal hypopressive technique (AHT) or pelvic floor muscle training (PFMT).
METHODS


Randomized controlled trial. Women with SUI who had not participated of physiotherapy program before were invited. The outcome measures were 7-day bladder diary, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and pelvic floor muscles (PFM) function measured by Modified Oxford grading System with vaginal palpation and manometry with Peritron. Intervention consisted by 12 weeks of exercises program including PFMT or AHT program, in groups of maximum three women, twice a week, with physiotherapist supervision.
RESULTS


AHT and PFMT groups reduced urinary leakage episodes in 7 days, -0.64 and -1.91, respectively, but PFMT was superior, whit mean difference -1.27 (95% confidence interval [CI]: -1.92 to -0,62) and effect size was 0.94 in favor to PFMT. Regarding to total score of ICIQ-SF, both groups improved, with mean difference between groups -4.7 (95% CI: -6.90 to -2.50) and effect size was 1.04 in favor to PFMT. Manometry also presented improvement after treatment for both groups with mean difference between them of 11 (95% CI: 6.33-15.67) and effect size was 1.15 also in favor to PFMT.
CONCLUSION


Regarding to SUI symptoms, quality of life impact and PFM function both groups presented improvement, however, PFMT was superior to AHT among all of them.",2020,"Regarding to SUI symptoms, quality of life impact and PFM function both groups presented improvement, however, PFMT was superior to AHT among all of them.",['Women with SUI who had not participated of physiotherapy program before were invited'],"['PFMT', 'exercises program including PFMT or AHT program', 'hypopressive technique (AHT) or pelvic floor muscle training (PFMT']","['urinary leakage episodes', '7-day bladder diary, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and pelvic floor muscles (PFM) function measured by Modified Oxford grading System with vaginal palpation and manometry with Peritron', 'SUI symptoms, quality of life impact and PFM function']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1273712', 'cui_str': 'Grading system used'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0024751', 'cui_str': 'Manometry'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}]",,0.168795,"Regarding to SUI symptoms, quality of life impact and PFM function both groups presented improvement, however, PFMT was superior to AHT among all of them.","[{'ForeName': 'Luciene A', 'Initials': 'LA', 'LastName': 'Jose-Vaz', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Carine L', 'Initials': 'CL', 'LastName': 'Andrade', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Cardoso', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Bruno T', 'Initials': 'BT', 'LastName': 'Bernardes', 'Affiliation': 'Gynecology and Obstetrics Department, Urogynaecology Ambulatory Unit, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Vanessa S', 'Initials': 'VS', 'LastName': 'Pereira-Baldon', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Ana Paula M', 'Initials': 'APM', 'LastName': 'Resende', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}]",Neurourology and urodynamics,['10.1002/nau.24489']
1378,32816144,Effects of a cooling vest with sham condition on walking capacity in heat-sensitive people with Multiple Sclerosis.,"PURPOSE


Heat sensitivity is a common contraindication in people with Multiple Sclerosis (pwMS), and physical fatigue is one of the most frequently reported symptoms that can affect quality of life. Increases in body temperature may exacerbate fatigue and heat-related symptoms. Decreasing body temperature via cooling devices may mitigate disease symptoms and improve physical abilities and quality of life. This study evaluates the effects of a cooling vest with sham condition on walking capacity using a commercially-available cooling vest specifically designed for pwMS.
METHODS


A counter-balanced, cross-over design was used to assess the effects of a cooling vest (CryoVest Comfort, CryoInnov, France) (COLD) from a menthol-induced sham condition (CON) on ground walking time to exhaustion (T ex , s) and distance at exhaustion (D ex , m) in ambulatory pwMS. Secondary outcomes were heart rate (HR, bpm), thermal sensation (Tsens), skin chest (Tchest) and back (Tback) temperature.
RESULTS


Ten females with Multiple Sclerosis (59 ± 9 years, EDSS 3.0-5.5) participated to the study. During COLD, pwMS walked significantly longer (1896 ± 602 vs. 1399 ± 404 s, p < 0.001) and farther (1879 ± 539 vs. 1302 ± 318 m, p < 0.001) than CON. Importantly, Tsens and HR at exhaustion were not significantly different between conditions, although Tchest (- 2.7 ± 1.8 °C, p < 0.01) and Tback (- 3.9 ± 1.8 °C, p < 0.001) were lower at volitional fatigue during COLD.
CONCLUSION


The lightweight cooling vest improved total walking time and distance in heat-sensitive pwMS. These physiological improvements were likely due to feeling perceptually cooler in the COLD trial, compared to the corresponding point of fatigue in the CON condition.",2020,"During COLD, pwMS walked significantly longer (1896 ± 602 vs. 1399 ± 404 s, p < 0.001) and farther (1879 ± 539 vs. 1302 ± 318 m, p < 0.001) than CON.","['people with Multiple Sclerosis (pwMS', 'Ten females with Multiple Sclerosis (59\u2009±\u20099\xa0years, EDSS 3.0-5.5) participated to the study', 'heat-sensitive people with Multiple Sclerosis']","['cooling vest (CryoVest Comfort, CryoInnov, France) (COLD) from a menthol-induced sham condition (CON', 'cooling vest with sham condition', 'lightweight cooling vest']","['total walking time and distance', 'walking capacity', 'Tsens and HR at exhaustion', 'ground walking time to exhaustion (T ex , s) and distance at exhaustion (D ex , m) in ambulatory pwMS', 'heart rate (HR, bpm), thermal sensation (Tsens), skin chest (Tchest) and back (Tback) temperature', 'physical abilities and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231274', 'cui_str': 'Intolerant of heat'}]","[{'cui': 'C0453884', 'cui_str': 'Vest'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0222149', 'cui_str': 'Skin structure of chest'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",10.0,0.0289915,"During COLD, pwMS walked significantly longer (1896 ± 602 vs. 1399 ± 404 s, p < 0.001) and farther (1879 ± 539 vs. 1302 ± 318 m, p < 0.001) than CON.","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Buoite Stella', 'Affiliation': 'Clinical Unit of Neurology, Department of Medicine, Surgery and Health Sciences, Cattinara University Hospital ASUGI, University of Trieste, Strada Di Fiume, 447, 34149, Trieste, Italy. abuoitestella@units.it.'}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Pasquin', 'Affiliation': 'Clinical Unit of Neurology, Department of Medicine, Surgery and Health Sciences, Cattinara University Hospital ASUGI, University of Trieste, Strada Di Fiume, 447, 34149, Trieste, Italy.'}, {'ForeName': 'Shawnda A', 'Initials': 'SA', 'LastName': 'Morrison', 'Affiliation': 'Faculty of Sport, University of Ljubljana, Gortanova 22, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'Maria Elisa', 'Initials': 'ME', 'LastName': 'Morelli', 'Affiliation': 'Clinical Unit of Neurology, Department of Medicine, Surgery and Health Sciences, Cattinara University Hospital ASUGI, University of Trieste, Strada Di Fiume, 447, 34149, Trieste, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Dinoto', 'Affiliation': 'Clinical Unit of Neurology, Department of Medicine, Surgery and Health Sciences, Cattinara University Hospital ASUGI, University of Trieste, Strada Di Fiume, 447, 34149, Trieste, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Bratina', 'Affiliation': 'Clinical Unit of Neurology, Department of Medicine, Surgery and Health Sciences, Cattinara University Hospital ASUGI, University of Trieste, Strada Di Fiume, 447, 34149, Trieste, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bosco', 'Affiliation': 'Clinical Unit of Neurology, Department of Medicine, Surgery and Health Sciences, Cattinara University Hospital ASUGI, University of Trieste, Strada Di Fiume, 447, 34149, Trieste, Italy.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Sartori', 'Affiliation': 'Clinical Unit of Neurology, Department of Medicine, Surgery and Health Sciences, Cattinara University Hospital ASUGI, University of Trieste, Strada Di Fiume, 447, 34149, Trieste, Italy.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Giudici', 'Affiliation': 'Statistics Unit, Department of Medicine, Surgery and Health Sciences, Cattinara University Hospital ASUGI, University of Trieste, Strada Di Fiume, 447, 34149, Trieste, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Manganotti', 'Affiliation': 'Clinical Unit of Neurology, Department of Medicine, Surgery and Health Sciences, Cattinara University Hospital ASUGI, University of Trieste, Strada Di Fiume, 447, 34149, Trieste, Italy.'}]",European journal of applied physiology,['10.1007/s00421-020-04478-3']
1379,32816189,Exercise training affects hemodynamics not cardiac function during anthracycline-based chemotherapy.,"INTRODUCTION


Preclinical data demonstrate the potential for exercise training to protect against anthracycline-related cardiotoxicity, but this remains to be shown in humans.
PURPOSE


To assess whether exercise training during anthracycline-based chemotherapy for treatment of breast cancer affects resting cardiac function and hemodynamics.
METHODS


In this prospective, non-randomized controlled study, 26 women who participated in aerobic and resistance training 3×/wk during chemotherapy were compared to 11 women receiving usual care. Two-dimensional echocardiography was performed before and 7-14 days after completion of anthracycline-based chemotherapy. Pre- and post-anthracycline cardiac function and hemodynamic variables were compared within each group with paired t-tests; the change was compared between groups using ANCOVA with adjustment for baseline values.
RESULTS


Left ventricular longitudinal strain, volumes, ejection fraction, E/A ratio, and mass did not change in either group. Hemoglobin, hematocrit, and mean arterial pressure decreased significantly from baseline in both groups (all p < 0.05) with no differences between groups. Cardiac output increased in the usual care group only (+ 0.27 ± 0.24 L/min/m 2 , p < 0.01), which differed significantly from the exercise group (p = 0.03). Systemic vascular resistance (SVR) decreased in both groups (usual care: - 444, p < 0.01; exercise: - 265, dynes/s/cm 5 , p = 0.01). However, the reduction in SVR was significantly attenuated in the exercise group (p = 0.03) perhaps due to a compensatory decrease in estimated vessel lumen radius.
CONCLUSION


Exercise training during anthracycline chemotherapy treatment had no effect on resting cardiac function but appeared to modify hemodynamic responses. Specifically, exercise training attenuated the drop in SVR in response to chemotherapy-related reductions in hematocrit potentially by increasing vessel lumen radius.",2020,"Systemic vascular resistance (SVR) decreased in both groups (usual care: - 444, p < 0.01; exercise: - 265, dynes/s/cm 5 , p = 0.01).","['11 women receiving usual care', '26 women who participated in']","['exercise training', 'aerobic and resistance training 3×/wk during chemotherapy', 'Exercise training', 'anthracycline-based chemotherapy', 'exercise training during anthracycline-based chemotherapy']","['Hemoglobin, hematocrit, and mean arterial pressure', 'Cardiac output', 'reduction in SVR', 'Pre- and post-anthracycline cardiac function and hemodynamic variables', 'resting cardiac function', 'Left ventricular longitudinal strain, volumes, ejection fraction, E/A ratio, and mass', 'Systemic vascular resistance (SVR']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",26.0,0.0287775,"Systemic vascular resistance (SVR) decreased in both groups (usual care: - 444, p < 0.01; exercise: - 265, dynes/s/cm 5 , p = 0.01).","[{'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Kirkham', 'Affiliation': 'University of Alberta, 1098 Research Transition Facility, 8308 114 Street NW, Edmonton, AB, T6G 2V2, Canada.'}, {'ForeName': 'Sean A', 'Initials': 'SA', 'LastName': 'Virani', 'Affiliation': 'University of British Columbia, 212-2177 Wesbrook Mall, Vancouver, V6T 1Z3, Canada.'}, {'ForeName': 'Kelcey A', 'Initials': 'KA', 'LastName': 'Bland', 'Affiliation': 'Australian Catholic University, 115 Victoria Parade, Fitzroy, VIC, 3065, Australia.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'McKenzie', 'Affiliation': 'University of British Columbia, 212-2177 Wesbrook Mall, Vancouver, V6T 1Z3, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Gelmon', 'Affiliation': 'University of British Columbia, 212-2177 Wesbrook Mall, Vancouver, V6T 1Z3, Canada.'}, {'ForeName': 'Darren E R', 'Initials': 'DER', 'LastName': 'Warburton', 'Affiliation': 'University of British Columbia, 212-2177 Wesbrook Mall, Vancouver, V6T 1Z3, Canada.'}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Campbell', 'Affiliation': 'University of British Columbia, 212-2177 Wesbrook Mall, Vancouver, V6T 1Z3, Canada. Kristin.Campbell@ubc.ca.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05824-x']
1380,32825556,"Acute Epigallocatechin-3-Gallate Supplementation Alters Postprandial Lipids after a Fast-Food Meal in Healthy Young Women: A Randomized, Double-Blind, Placebo-Controlled Crossover Study.","A high-fat fast-food meal negatively impacts postprandial metabolism even in healthy young people. In experimental studies, epigallocatechin-3-gallate (EGCG), a bioactive compound present in green tea, has been described as a potent natural inhibitor of fatty acid synthase. Thus, we sought to evaluate the effects of acute EGCG supplementation on postprandial lipid profile, glucose, and insulin levels following a high-fat fast-food meal. Fourteen healthy young women 21 ± 1 years and body mass index 21.4 ± 0.41 kg/m 2  were enrolled in a randomized, double-blind, placebo-controlled crossover study. Participants ingested capsules containing 800 mg EGCG or placebo immediately before a typical fast-food meal rich in saturated fatty acids. Blood samples were collected at baseline and then at 90 and 120 min after the meal. The EGCG treatment attenuated postprandial triglycerides ( p  = 0.029) and decreased high-density lipoprotein cholesterol (HDL-c) ( p  = 0.016) at 120 min. No treatment × time interaction was found for total cholesterol, low-density lipoprotein (LDL-c), and glucose or insulin levels. The incremental area under the curve (iAUC) for glucose was decreased by EGCG treatment ( p  < 0.05). No difference was observed in the iAUC for triglycerides and HDL-c. In healthy young women, acute EGCG supplementation attenuated postprandial triglycerides and glucose but negatively impacted HDL-c following a fast-food meal.",2020,"No treatment × time interaction was found for total cholesterol, low-density lipoprotein (LDL-c), and glucose or insulin levels.","['Healthy Young Women', 'healthy young people', 'Fourteen healthy young women 21 ± 1 years and body mass index 21.4 ± 0.41 kg/m 2', 'healthy young women']","['Placebo', 'EGCG', 'acute EGCG supplementation', 'EGCG or placebo', 'epigallocatechin-3-gallate (EGCG', 'Acute Epigallocatechin-3-Gallate Supplementation', 'placebo']","['incremental area under the curve (iAUC) for glucose', 'high-density lipoprotein cholesterol (HDL-c', 'iAUC for triglycerides and HDL-c', 'postprandial triglycerides', 'Blood samples', 'postprandial lipid profile, glucose, and insulin levels', 'total cholesterol, low-density lipoprotein (LDL-c), and glucose or insulin levels', 'postprandial triglycerides and glucose']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",14.0,0.329711,"No treatment × time interaction was found for total cholesterol, low-density lipoprotein (LDL-c), and glucose or insulin levels.","[{'ForeName': 'Alcides C', 'Initials': 'AC', 'LastName': 'de Morais Junior', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goiás (UFG), Goiania 74690-900, GO, Brazil.'}, {'ForeName': 'Raquel M', 'Initials': 'RM', 'LastName': 'Schincaglia', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goiás (UFG), Goiania 74690-900, GO, Brazil.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Passarelli', 'Affiliation': 'Laboratório de Lípides (LIM 10), Hospital das Clínicas (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo 05403-900, Brazil.'}, {'ForeName': 'Gustavo D', 'Initials': 'GD', 'LastName': 'Pimentel', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goiás (UFG), Goiania 74690-900, GO, Brazil.'}, {'ForeName': 'João F', 'Initials': 'JF', 'LastName': 'Mota', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goiás (UFG), Goiania 74690-900, GO, Brazil.'}]",Nutrients,['10.3390/nu12092533']
1381,32822968,"Improvement in overall survival with Apalutamide, Darolutamide and Enzalutamide in patients with non-metastatic castration-resistant prostate cancer.","Since 2018, apalutamide, darolutamide, and enzalutamide have been approved for the treatment of men with non-metastatic castration-resistant prostate cancer (M0CRPC). These approvals were based on the results of three separate randomized, placebo-controlled, phase III trials: SPARTAN (apalutamide), ARAMIS (darolutamide) and PROSPER (enzalutamide). These trials included men with M0CRPC and a short PSA doubling time (≤10 months). Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone. Updated results of these trials presented in the 2020 annual meeting of American Society of Oncology (ASCO) showed significantly improved overall survival with these agents. Based on these results, apalutamide, darolutamide, and enzalutamide can now be considered the standard of care treatment options for the treatment of men with M0CRPC.",2020,"Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone.","['men with M0CRPC and a short PSA doubling time (≤10 months', 'men with non-metastatic castration-resistant prostate cancer (M0CRPC', 'men with M0CRPC', 'patients with non-metastatic castration-resistant prostate cancer']","['Apalutamide, Darolutamide and Enzalutamide', 'ARAMIS (darolutamide) and PROSPER (enzalutamide', 'androgen deprivation therapy (ADT', 'placebo']","['overall survival', 'longer metastasis-free survival']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.0449496,"Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone.","[{'ForeName': 'Umang', 'Initials': 'U', 'LastName': 'Swami', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA. Electronic address: umang.swami@hci.utah.edu.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2020.100205']
1382,32824190,The Smartphone-Assisted Intervention Improved Perception of Nutritional Status among Middle School Students.,"Misperception of nutritional status is common and hinders the progress of childhood obesity prevention. This study aimed to examine the effectiveness of a smartphone-assisted intervention to improve student and parental perception of students' nutritional status (underweight, normal weight, overweight, obese). We conducted a parallel-group controlled trial with a non-randomized design in three junior middle schools of Beijing, China in 2019. One school was allocated to the intervention group and two schools to the control group. A total of 573 students (aged 13.1 ± 0.4 years) participated in the trial. The 3-month intervention included three components: health education sessions for students and parents, regular monitoring of students' weight, and the provision of feedback via a smartphone application. Schools in the control group continued their usual practice. Primary outcomes included the student and parental accurate perception of students' nutritional status. The percentage of students' accurate perception of their own nutritional status in the intervention group increased from 49.0% to 59.2% from baseline to three months, whereas it decreased from 64.1% to 58.1% in the control group; the adjusted odds ratio (OR) between the two groups was 1.71 (95% confidence interval (CI): 1.13, 2.59). The intervention did not significantly improve parental perception of students' nutritional status ( p  > 0.05). The study findings provided a brief approach for improving perception of nutritional status among middle school students.",2020,The intervention did not significantly improve parental perception of students' nutritional status ( p  > 0.05).,"['Middle School Students', 'middle school students', 'three junior middle schools of Beijing, China in 2019', 'A total of 573 students (aged 13.1 ± 0.4 years) participated in the trial', ""students' nutritional status (underweight, normal weight, overweight, obese""]","['Smartphone-Assisted Intervention', 'smartphone-assisted intervention', ""health education sessions for students and parents, regular monitoring of students' weight, and the provision of feedback via a smartphone application""]","[""student and parental accurate perception of students' nutritional status"", ""parental perception of students' nutritional status"", ""percentage of students' accurate perception of their own nutritional status""]","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",3.0,0.0150395,The intervention did not significantly improve parental perception of students' nutritional status ( p  > 0.05).,"[{'ForeName': 'Yan-Hui', 'Initials': 'YH', 'LastName': 'Shen', 'Affiliation': 'Department of School Health, Beijing Haidian District Center for Diseases Prevention and Control, Beijing 100095, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Wen-Hao', 'Initials': 'WH', 'LastName': 'Li', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Jin-Hui', 'Initials': 'JH', 'LastName': 'Xu', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Chu', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Department of School Health, Beijing Haidian District Center for Diseases Prevention and Control, Beijing 100095, China.'}, {'ForeName': 'Hai-Jun', 'Initials': 'HJ', 'LastName': 'Wang', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17165932']
1383,32824920,Can Creatine Supplementation Interfere with Muscle Strength and Fatigue in Brazilian National Level Paralympic Powerlifting?,"The aim of the present study was to analyze the effect of creatine (Cr) supplementation on peak torque (PT) and fatigue rate in Paralympic weightlifting athletes. Eight Paralympic powerlifting athletes participated in the study, with 25.40 ± 3.30 years and 70.30 ± 12.15 kg. The measurements of muscle strength, fatigue index (FI), peak torque (PT), force (kgf), force (N), rate of force development (RFD), and time to maximum isometric force (time) were determined by a Musclelab load cell. The study was performed in a single-blind manner, with subjects conducting the experiments first with placebo supplementation and then, following a 7-day washout period, beginning the same protocol with creatine supplementation for 7 days. This sequence was chosen because of the lengthy washout of creatine. Regarding the comparison between conditions, Cr supplementation did not show effects on the variables of muscle force, peak torque, RFD, and time to maximum isometric force ( p  > 0.05). However, when comparing the results of the moments with the use of Cr and placebo, a difference was observed for the FI after seven days (U 3 : 1.12; 95% CI: (0.03, 2.27);  p  = 0.02); therefore, the FI was higher for placebo. Creatine supplementation has a positive effect on the performance of Paralympic powerlifting athletes, reducing fatigue index, and keeping the force levels as well as PT.",2020,"Regarding the comparison between conditions, Cr supplementation did not show effects on the variables of muscle force, peak torque, RFD, and time to maximum isometric force ( p  > 0.05).","['Paralympic weightlifting athletes', 'Eight Paralympic powerlifting athletes participated in the study, with 25.40 ± 3.30 years and 70.30 ± 12.15 kg']","['placebo', 'Creatine supplementation', 'creatine (Cr) supplementation', 'placebo supplementation']","['muscle strength, fatigue index (FI), peak torque (PT), force (kgf), force (N), rate of force development (RFD), and time to maximum isometric force (time', 'muscle force, peak torque, RFD, and time to maximum isometric force', 'peak torque (PT) and fatigue rate']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",,0.0998311,"Regarding the comparison between conditions, Cr supplementation did not show effects on the variables of muscle force, peak torque, RFD, and time to maximum isometric force ( p  > 0.05).","[{'ForeName': 'Carlos Rodrigo', 'Initials': 'CR', 'LastName': 'Soares Freitas Sampaio', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Felipe J', 'Initials': 'FJ', 'LastName': 'Aidar', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Alexandre R P', 'Initials': 'ARP', 'LastName': 'Ferreira', 'Affiliation': 'College of Physical Education and Exercise Science, University of Brasília (UnB), Brasília 70910-900, Brazil.'}, {'ForeName': 'Jymmys Lopes Dos', 'Initials': 'JLD', 'LastName': 'Santos', 'Affiliation': 'Program in Biotechnology, Northeast Network in Biotechnology (RENORBIO), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Anderson Carlos', 'Initials': 'AC', 'LastName': 'Marçal', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Dihogo Gama de', 'Initials': 'DG', 'LastName': 'Matos', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Raphael Fabrício de', 'Initials': 'RF', 'LastName': 'Souza', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Osvaldo Costa', 'Initials': 'OC', 'LastName': 'Moreira', 'Affiliation': 'Institute of Biological Sciences and Health, Federal University of Viçosa, Campus Florestal, Minas Gerais 35690-000, Brazil.'}, {'ForeName': 'Ialuska', 'Initials': 'I', 'LastName': 'Guerra', 'Affiliation': 'Federal Institute of Education, Science and Technology of Ceará (IFCE), Campus of Juazeiro do Norte, Ceará 63040-540, Brazil.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Fernandes Filho', 'Affiliation': 'Brazilian Paralympic Academy, Brazilian Paralympic Committee, São Paulo 04329-000, SP, Brazil.'}, {'ForeName': 'Lucas Soares', 'Initials': 'LS', 'LastName': 'Marcucci-Barbosa', 'Affiliation': 'Laboratory of Inflammation and Exercise Immunology, Sports Center, Physical Education Scholl, Federal University of OuroPreto (UFOP), OuroPreto, Minas Gerais 35400-000, Brazil.'}, {'ForeName': 'Albená', 'Initials': 'A', 'LastName': 'Nunes-Silva', 'Affiliation': 'Laboratory of Inflammation and Exercise Immunology, Sports Center, Physical Education Scholl, Federal University of OuroPreto (UFOP), OuroPreto, Minas Gerais 35400-000, Brazil.'}, {'ForeName': 'Paulo Francisco de', 'Initials': 'PF', 'LastName': 'Almeida-Neto', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte (UFRN), Natal, Rio Grande do Norte 59078-970, Brazil.'}, {'ForeName': 'Breno Guilherme Araújo Tinoco', 'Initials': 'BGAT', 'LastName': 'Cabral', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte (UFRN), Natal, Rio Grande do Norte 59078-970, Brazil.'}, {'ForeName': 'Victor Machado', 'Initials': 'VM', 'LastName': 'Reis', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), Trásos Montes and Alto Douro University, 5001-801 Vila Real, Portugal.'}]",Nutrients,['10.3390/nu12092492']
1384,32829925,[Effects of music therapy on pain and oxidative stress in oocyte pick-up: a randomized clinical trial].,"BACKGROUND AND OBJECTIVE


The aim was to investigate the effects of Turkish classical music on pain and oxidative stress in patients undergoing oocyte pick-up.
METHODS


The study was a randomized, controlled trial. The groups included were Group NM (Non-Music), control group; Group PM, which comprised patients who listened to music before the operation; and Group CM, which comprised patients who listened to music both before and during the operation. Blood was drawn prior to the operation to measure the oxidative stress values. Pain, hemodynamic parameters, oxidative stress values were assessed postoperatively.
RESULTS


The number of patients requiring additional propofol was higher in Group PM than in Groups NM and CM (p=0.003). The postoperative Visual Analog Scale (VAS) score were lower in Groups PM and CM than in Group NM (p=0.001, p=0.007) in the 1 st  and 60 th  minutes. The postoperative VAS score was lower in Group CM than in Group NM (p=0.045) in the 5 th  minute. The postoperative additional analgesic requirements were lower in Groups PM and CM than in Group NM (p=0.045). The postoperative blood glutathione peroxidase values were significantly higher in Groups PM and CM than in Group NM (p=0.001). The postoperative catalase values were significantly higher in Groups PM and CM than in Group NM (p=0.008 and p ≤0.001). The preoperative malondialdehyde values were significantly lower in Groups PM and CM than in Group NM. The preoperative nitric oxide values were higher in Groups PM and CM than in Group NM (p ≤0.001), whereas the postoperative nitric oxide values were lower in Groups PM and CM than in Group NM (p ≤0.001).
CONCLUSION


Turkish classical music has beneficial effects on pain and oxidative stress in oocyte pick-up patients.",2020,The postoperative additional analgesic requirements were lower in Groups PM and CM than in Group NM (p=0.045).,"['patients undergoing oocyte pick-up', 'oocyte pick-up']","['control group; Group PM, which comprised patients who listened to music before the operation; and Group CM', 'music therapy', 'Turkish classical music']","['postoperative VAS score', 'postoperative blood glutathione peroxidase values', 'oxidative stress values', 'postoperative catalase values', 'preoperative malondialdehyde values', 'Pain, hemodynamic parameters, oxidative stress values', 'number of patients requiring additional propofol', 'postoperative additional analgesic requirements', 'postoperative nitric oxide values', 'preoperative nitric oxide values', 'postoperative Visual Analog Scale (VAS) score', 'pain and oxidative stress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0356329,The postoperative additional analgesic requirements were lower in Groups PM and CM than in Group NM (p=0.045).,"[{'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Orak', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Onikişubat, Turquia. Electronic address: dryavuzorak@hotmail.com.'}, {'ForeName': 'Suleyman Murat', 'Initials': 'SM', 'LastName': 'Bakacak', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Department of Obstetrics and Gynecology, Onikişubat, Turquia.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Yaylali', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Histology Department, Onikişubat, Turquia.'}, {'ForeName': 'Fatma Inanc', 'Initials': 'FI', 'LastName': 'Tolun', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Department of Biochemistry, Onikişubat, Turquia.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Kiran', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Department of Obstetrics and Gynecology, Onikişubat, Turquia.'}, {'ForeName': 'Omer Faruk', 'Initials': 'OF', 'LastName': 'Boran', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Onikişubat, Turquia.'}, {'ForeName': 'Akif Hakan', 'Initials': 'AH', 'LastName': 'Kurt', 'Affiliation': 'Bolu Abant Izzet Baysal University, Faculty of Medicine, Medical Pharmacology, Bolu, Turquia.'}, {'ForeName': 'Adem', 'Initials': 'A', 'LastName': 'Doganer', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Biostatistics and Medical Informatics, Onikişubat, Turquia.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.04.015']
1385,32837750,The Efficacy and Safety of Triazavirin for COVID-19: A Trial Protocol.,"The coronavirus disease 2019 (COVID-19), a pneumonia caused by a novel coronavirus, was reported in December 2019. COVID-19 is highly contagious and has rapidly developed from a regional epidemic into a global pandemic. As yet, no effective drugs have been found to treat this virus. This study, an ongoing multicenter and blind randomized controlled trial (RCT), is being conducted at ten study sites in Heilongjiang Province, China, to investigate the efficacy and safety of Triazavirin (TZV) versus its placebo in COVID-19 patients. A total of 240 participants with COVID-19 are scheduled to be enrolled in this trial. Participants with positive tests of throat swab virus nucleic acid are randomized (1:1) into two groups: standard therapy plus TZV or standard therapy plus placebo for a 7-day treatment with a 21-day follow-up. The primary outcome is the time to clinical improvement of the subjects. Secondary outcomes include clinical improvement rate, time to alleviation of fever, mean time and proportion of obvious inflammatory absorption in the lung, conversion rate of repeated negative virus nucleic acid tests, mortality rate, and conversion rate to severe and critically severe patients. Adverse events, serious adverse events, liver function, kidney function and concurrent treatments will be monitored and recorded throughout the trial. The results of this trial should provide evidence-based recommendations to clinicians for the treatment of COVID-19.",2020,"The coronavirus disease 2019 (COVID-19), a pneumonia caused by a novel coronavirus, was reported in December 2019.","['240 participants with COVID-19 are scheduled to be enrolled in this trial', 'COVID-19 patients', 'Participants with positive tests of throat swab virus nucleic acid']","['placebo', 'Triazavirin (TZV', 'Triazavirin for COVID-19', 'standard therapy plus TZV or standard therapy plus placebo']","['clinical improvement rate, time to alleviation of fever, mean time and proportion of obvious inflammatory absorption in the lung, conversion rate of repeated negative virus nucleic acid tests, mortality rate, and conversion rate to severe and critically severe patients', 'Adverse events, serious adverse events, liver function, kidney function', 'time to clinical improvement of the subjects']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2714695', 'cui_str': 'triazavirin'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",240.0,0.261526,"The coronavirus disease 2019 (COVID-19), a pneumonia caused by a novel coronavirus, was reported in December 2019.","[{'ForeName': 'Xiaoke', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'College of Pharmacology, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Kaijiang', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': 'The First Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Yongchen', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The Second Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Wanhai', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'The Fourth Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'College of Pharmacology, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Benzhi', 'Initials': 'B', 'LastName': 'Cai', 'Affiliation': 'The Second Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'The Fourth Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Heilongjiang Provincial Hospital, Harbin Institute of Technology, Harbin 150030, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Heilongjiang Provincial Hospital, Harbin Institute of Technology, Harbin 150030, China.'}, {'ForeName': 'Jingshu', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China.'}, {'ForeName': 'Huichao', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China.'}, {'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'The First Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'College of Pharmacology, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'College of Pharmacology, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Du', 'Affiliation': 'The Second Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Baofeng', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'College of Pharmacology, Harbin Medical University, Harbin 150001, China.'}]","Engineering (Beijing, China)",['10.1016/j.eng.2020.06.011']
1386,32837847,"A Randomized, Open-label, Controlled Clinical Trial of Azvudine Tablets in the Treatment of Mild and Common COVID-19, A Pilot Study.","Coronavirus disease 2019 (COVID-19) has spread worldwide. To date, no specific drug for COVID-19 has been developed. Thus we performed this randomized, open-label, controlled clinical trial (ChiCTR2000029853) in China. A total of 20 mild and common COVID-19 patients were enrolled and randomly assigned to receive azvudine and symptomatic treatment (FNC group), or standard antiviral and symptomatic treatments (control group). The mean times of the first nucleic acid negative conversion (NANC) of 10 patients in the FNC group and 10 patients in the control group were 2.60 (SD 0.97; range 1-4) days and 5.60 (SD 3.06; range 2-13) days, respectively (p = 0.08). The mean times of the first NANC of 4 newly diagnosed subjects in the FNC group and 10 subjects in the control group were 2.50 (SD 1.00; range 2-4) days and 9.80 (SD 4.73; range 3-19) days, respectively (starting from the initial treatment) (p = 0.01). No adverse events occurred in the FNC group, while 3 adverse events occurred in the control group (p = 0.06). The preliminary results showed that FNC treatment in the mild and common COVID-19 may shorten the NANC time versus standard antiviral treatment. Therefore, clinical trials of FNC treating COVID-19 with larger sample size are warranted.",2020,"No adverse events occurred in the FNC group, while 3 adverse events occurred in the control group (p = 0.06).",['A total of 20 mild and common COVID-19 patients'],"['Azvudine Tablets', 'azvudine and symptomatic treatment (FNC group), or standard antiviral and symptomatic treatments (control group', 'FNC']","['NANC time', 'mean times of the first nucleic acid negative conversion (NANC', 'adverse events', 'mean times of the first NANC']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4045536', 'cui_str': 'azvudine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",20.0,0.0744737,"No adverse events occurred in the FNC group, while 3 adverse events occurred in the control group (p = 0.06).","[{'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Department of Infectious Diseases the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Zujiang', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Infectious Diseases the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China.'}, {'ForeName': 'Jingchao', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Thoracic Surgery Henan Provincial Chest Hospital Zhengzhou 450008 China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Henan Key Laboratory of Organic Functional Molecule and Drug Innovation School of Chemistry and Chemical Engineering Henan Normal University Xinxiang 453007 China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Haiyu', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China.'}, {'ForeName': 'Guangying', 'Initials': 'G', 'LastName': 'Cui', 'Affiliation': 'Department of Infectious Diseases the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Henan Genuine Biotech Co., Ltd. 10 Fuxing Road, Xincheng District Pingdingshan Henan 467036 P. R. China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedics Huangchuan County People's Hospital Huangchuan County Xinyang 465150 China.""}, {'ForeName': 'Qingquan', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Medical Department Xixian people's Hospital Xixian Xinyang 464300 China.""}, {'ForeName': 'Zhaohai', 'Initials': 'Z', 'LastName': 'Zeng', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Shengkun', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Guangzhong', 'Initials': 'G', 'LastName': 'Pei', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Yonghui', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Thoracic Surgery Henan Provincial Chest Hospital Zhengzhou 450008 China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Wenquan', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Henan new drug creation and drug safety evaluation Collaborative Innovation Center Zhengzhou University Zhengzhou 450001 China.'}, {'ForeName': 'Chuanjun', 'Initials': 'C', 'LastName': 'Song', 'Affiliation': 'Henan new drug creation and drug safety evaluation Collaborative Innovation Center Zhengzhou University Zhengzhou 450001 China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Henan new drug creation and drug safety evaluation Collaborative Innovation Center Zhengzhou University Zhengzhou 450001 China.'}, {'ForeName': 'Chuansong', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Jinfa', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Henan Genuine Biotech Co., Ltd. 10 Fuxing Road, Xincheng District Pingdingshan Henan 467036 P. R. China.'}, {'ForeName': 'Junbiao', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Henan Key Laboratory of Organic Functional Molecule and Drug Innovation School of Chemistry and Chemical Engineering Henan Normal University Xinxiang 453007 China.'}]","Advanced science (Weinheim, Baden-Wurttemberg, Germany)",['10.1002/advs.202001435']
1387,32840891,Randomized controlled trial on the effectiveness of web-based Genomics Nursing Education Intervention for undergraduate nursing students: a study protocol.,"AIM


To describe a randomized controlled trial protocol that will evaluate the effectiveness of two web-based genomic nursing education interventions.
BACKGROUND


Preparing future nurses to be competent in genetic and genomic concepts is fundamental to ensure appropriate clinical application. However, genetics-genomics concepts are still new in the field of nursing. Little is known about what type and kind of web-based nursing education is effective in improving the knowledge of nursing students. To address these knowledge gaps, a web-based 'Genomic Nursing Education Intervention' will be developed and compared with an existing online education programme.
DESIGN


A randomized controlled trial of two groups with pre-test and repeated posttesting.
METHODS


The Genomic Nursing Concept Inventory, a validated tool, will be used to assess the genetics-genomics knowledge of nursing students. Participants will be randomly allocated to either a control or an intervention group. The control group will receive the standard web-based nursing education, while the intervention group will receive a newly developed web-based education intervention. Outcome measures include the students' knowledge level of nursing genetics-genomics concepts. Participants will be retested at 3 and 6 months.
CONCLUSION


Current evidence shows that ensuring nurses have adequate education in genetic-genomic concepts is challenging. This study will demonstrate which of two web-based nursing education methods is more effective in teaching genetic-genomic concepts. This research project will better prepare the nursing profession in their careers for the emerging advance technologies in genetics-genomics and personalized health care.
IMPACT


Current evidence shows major challenges in ensuring that nurses have adequate education in genetics-genomics concepts. Less is known about what approaches to web-based education are effective to improve the knowledge gaps of nursing students in genetics-genomics concepts. This study will determine which type of web-based nursing education is effective in improving the genetics-genomics knowledge of nursing students. This research project will help better prepare nurses in dealing with advances in genetics-genomics in their careers.
TRIAL REGISTRATION


This study is registered in ClinicalTrials.gov (ID number NCT03963687) https://clinicaltrials.gov/show/NCT03963687.",2020,Little is known about what type and kind of web-based nursing education is effective in improving the knowledge of nursing students.,"['nursing students', 'undergraduate nursing students']","['standard web-based nursing education, while the intervention group will receive a newly developed web-based education intervention', 'web-based Genomics Nursing Education Intervention']","[""students' knowledge level of nursing genetics-genomics concepts""]","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013636', 'cui_str': 'Nursing Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0017428', 'cui_str': 'Genome'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0871796', 'cui_str': 'Knowledge level'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0017428', 'cui_str': 'Genome'}]",,0.117689,Little is known about what type and kind of web-based nursing education is effective in improving the knowledge of nursing students.,"[{'ForeName': 'Anndra Margareth', 'Initials': 'AM', 'LastName': 'Dumo', 'Affiliation': 'University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Bobbi', 'Initials': 'B', 'LastName': 'Laing', 'Affiliation': 'School of Nursing, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anecita Gigi', 'Initials': 'AG', 'LastName': 'Lim', 'Affiliation': 'School of Nursing, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Erlinda', 'Initials': 'E', 'LastName': 'Palaganas', 'Affiliation': 'University of the Philippines, Baguio, Philippines.'}, {'ForeName': 'Peter James', 'Initials': 'PJ', 'LastName': 'Abad', 'Affiliation': 'College of Nursing, University of the Philippines, Manila, Philippines.'}, {'ForeName': 'Ofelia', 'Initials': 'O', 'LastName': 'Valdehueza', 'Affiliation': 'Don Mariano Marcos Memorial State University, La Union, Philippines.'}, {'ForeName': 'Marjo', 'Initials': 'M', 'LastName': 'Palovaara', 'Affiliation': 'Jyväskylä University of Applied Sciences, Jyväskylä, Finland.'}, {'ForeName': 'Hannele', 'Initials': 'H', 'LastName': 'Saunders', 'Affiliation': 'South-Eastern Finland University of Applied Sciences, Kouvola, Finland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Estola', 'Affiliation': 'University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Mandysova', 'Affiliation': 'Department of Nursing, Faculty of Health Studies, University of Pardubice, Pardubice, Czech Republic.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Maguire', 'Affiliation': 'Faculty of Health, University of Technology, Sydney, Australia.'}, {'ForeName': 'Linda D', 'Initials': 'LD', 'LastName': 'Ward', 'Affiliation': 'Clemson University School of Nursing, Clemson, SC, USA.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Carlberg', 'Affiliation': 'University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Katri', 'Initials': 'K', 'LastName': 'Vehviläinen-Julkunen', 'Affiliation': 'University of Eastern Finland, Kuopio, Finland.'}]",Journal of advanced nursing,['10.1111/jan.14477']
1388,32833763,"3D Versus 4K Display System - Influence of ""State-of-the-art""-Display Technique on Surgical Performance (IDOSP-study) in Minimally Invasive Surgery: A Randomized Cross-over Trial.","OBJECTIVE


To evaluate if ""state-of-the-art"" 3D- versus 4K-display techniques could influence surgical performance.
BACKGROUND


High quality minimally invasive surgery is challenging. Therefore excellent vision is crucial. 3D display technique (3D) and 2D-4K technique (4K) are designed to facilitate surgical performance, either due to spatial resolution (3D) or due to very high resolution (4K).
METHODS


In randomized cross-over trial the surgical performance of medical students (MS), non-board certified surgeons (NBC), and board certified surgeons (BC) was compared using 3D versus 4K display technique at a minimally invasive training Parkour.
RESULTS


One hundred twenty-eight participants were included (February 2018 through October 2019, 49 MS, 39 NBC, 40 BC). The overall Parkour time (s) 3D versus 4K was 712.5 s ± 17.5 s versus 999.5 s ± 25.1 s (P < 0.001) for all levels of experience. It was (3D vs 4K) for MS (30 tasks) 555.4 s ± 28.9 s versus 858.7 s ± 41.6 s, (P < 0.0001), for NBC (42 tasks) 935.9 s ± 31.5 s versus 1274.1 s ± 45.1 s (P =< 0.001) and for BC (42 task) 646.3 s ± 30.9 s versus 865.7 s ± 43.7 s (P < 0.001). The overall number of mistakes was (3D vs 4K) 10.0 ± 0.5 versus 13.3 ± 0.7 (P < 0.001), for MS 8.9 ± 0.9 versus 13.1 ± 1.1 (P < 0.001), for NBC 12.45 ± 1.0 versus 16.7 ± 1.2 (P < 0.001) and for BC 8.8 ± 1.0 versus 10.0 ± 1.2 (P = 0.18). MS, BC, and NBC showed shorter performance time in 100% of the task with 3D (significantly in 6/7 tasks). For number of mistakes the effect was less pronounced for more experienced surgeons. The National Aeronautics and Space Administration-task load index was lower with 3D.
CONCLUSION


3D laparoscopic display technique optimizes surgical performance compared to the 4K technique. Surgeons benefit from the improved visualization regardless of their individual surgical expertise.",2020,"The National Aeronautics and Space Administration-task load index was lower with 3D.
CONCLUSION


","['One hundred twenty-eight participants were included (February 2018 through October 2019, 49 MS, 39 NBC, 40 BC', 'medical students (MS), non-board certified surgeons (NBC), and board certified surgeons (BC', 'Minimally Invasive Surgery']",['3D display technique (3D) and 2D-4K technique (4K'],"['overall number of mistakes', 'MS, BC, and NBC showed shorter performance time', 'overall Parkour time (s']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",128.0,0.079681,"The National Aeronautics and Space Administration-task load index was lower with 3D.
CONCLUSION


","[{'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Wahba', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Rabi', 'Initials': 'R', 'LastName': 'Datta', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Bußhoff', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruns', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hedergott', 'Affiliation': 'Department of Ophthalmology, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gietzelt', 'Affiliation': 'Department of Ophthalmology, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Dieplinger', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Fuchs', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Morgenstern', 'Affiliation': 'Department of Gynecology and Gynecologic Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Desdemona', 'Initials': 'D', 'LastName': 'Möller', 'Affiliation': 'Faculty of Management, Economics and Social Sciences, Department of Business Administration and Health Care Management, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Christiane J', 'Initials': 'CJ', 'LastName': 'Bruns', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Dirk L', 'Initials': 'DL', 'LastName': 'Stippel', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}]",Annals of surgery,['10.1097/SLA.0000000000004328']
1389,32833767,Surgical Morbidity and Mortality From the Multicenter Randomized Controlled NeoRes II Trial: Standard Versus Prolonged Time to Surgery After Neoadjuvant Chemoradiotherapy for Esophageal Cancer.,"OBJECTIVE


To investigate if prolonged TTS after completed nCRT improves postoperative outcomes for esophageal and esophagogastric junction cancer.
SUMMARY OF BACKGROUND DATA


TTS has traditionally been 4-6 weeks after completed nCRT. However, the optimal timing is not known.
METHODS


A multicenter clinical trial was performed with randomized allocation of TTS of 4-6 or 10-12 weeks. The primary endpoint of this sub-study was overall postoperative complications defined as Clavien-Dindo grade II-V. Secondary endpoints included complication severity according to Clavien-Dindo grade IIIb-V, postoperative 90-day mortality, and length of hospital stay. The study was registered in Clinicaltrials.gov (NCT02415101).
RESULTS


In total 249 patients were randomized. There were no significant differences between standard TTS and prolonged TTS with regard to overall incidence of complications Clavien-Dindo grade II-V (63.2% vs 72.6%, P = 0.134) or regarding Clavien-Dindo grade IIIb-V complications (31.6% vs 34.9%, P = 0.603). There were no statistically significant differences between standard and prolonged TTS regarding anastomotic leak (P = 0.596), conduit necrosis (P = 0.524), chyle leak (P = 0.427), pneumonia (P = 0.548), and respiratory failure (P = 0.723). In the standard TTS arm 5 patients (4.3%) died within 90 days of surgery, compared to 4 patients (3.8%) in the prolonged TTS arm (P = 1.0). Median length of hospital stay was 15 days in the standard TTS arm and 17 days in the prolonged TTS arm (P = 0.234).
CONCLUSION


The timing of surgery after completed nCRT for carcinoma of the esophagus or esophagogastric junction, is not of major importance with regard to short-term postoperative outcomes.",2020,"There were no significant differences between standard TTS and prolonged TTS with regard to overall incidence of complications Clavien-Dindo grade II-V (63.2% vs 72.6%, P = 0.134) or regarding Clavien-Dindo grade IIIb-V complications (31.6% vs 34.9%, P = 0.603).","['Esophageal Cancer', 'esophageal and esophagogastric junction cancer', 'In total 249 patients']","['Prolonged Time to Surgery', 'nCRT', 'Neoadjuvant Chemoradiotherapy', 'TTS']","['standard and prolonged TTS regarding anastomotic leak', 'pneumonia', 'conduit necrosis', 'Surgical Morbidity and Mortality', 'Median length of hospital stay', 'overall postoperative complications defined as Clavien-Dindo grade II-V. Secondary endpoints included complication severity according to Clavien-Dindo grade IIIb-V, postoperative 90-day mortality, and length of hospital stay', 'Clavien-Dindo grade IIIb-V complications', 'respiratory failure', 'chyle leak', 'overall incidence of complications Clavien-Dindo grade II-V']","[{'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0441247', 'cui_str': 'Conduit'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0008730', 'cui_str': 'Chyle'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",249.0,0.272683,"There were no significant differences between standard TTS and prolonged TTS with regard to overall incidence of complications Clavien-Dindo grade II-V (63.2% vs 72.6%, P = 0.134) or regarding Clavien-Dindo grade IIIb-V complications (31.6% vs 34.9%, P = 0.603).","[{'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Nilsson', 'Affiliation': 'Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Klevebro', 'Affiliation': 'Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Rouvelas', 'Affiliation': 'Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lindblad', 'Affiliation': 'Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Szabo', 'Affiliation': 'Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Ingvar', 'Initials': 'I', 'LastName': 'Halldestam', 'Affiliation': 'Department of Surgery, University Hospital of Linköping, Linköping, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Smedh', 'Affiliation': 'Department of Surgery, Sahlgrenska University Hospital, Gothenburg Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Wallner', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Umeå University Hospital, Umeå, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Johansson', 'Affiliation': 'Department of Surgery, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Gjermund', 'Initials': 'G', 'LastName': 'Johnsen', 'Affiliation': ""Department of Gastrointestinal Surgery, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.""}, {'ForeName': 'Eirik Kjus', 'Initials': 'EK', 'LastName': 'Aahlin', 'Affiliation': 'Department of GI and HPB Surgery, University Hospital of Northern Norway, Tromsø, Norway.'}, {'ForeName': 'Hans-Olaf', 'Initials': 'HO', 'LastName': 'Johannessen', 'Affiliation': 'Department of Gastrointestinal Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Geir Olav', 'Initials': 'GO', 'LastName': 'Hjortland', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Bartella', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schröder', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Bruns', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Nilsson', 'Affiliation': 'Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.'}]",Annals of surgery,['10.1097/SLA.0000000000004340']
1390,32833851,Ultrasound-guided interscalene block combined with intermediate or superficial cervical plexus block for clavicle surgery: A randomised double blind study.,"BACKGROUND


The complex innervation of the clavicle makes general anaesthesia a preferred technique for clavicular surgeries in current practice. The role and approach of regional anaesthesia remains unanswered.
OBJECTIVES


This study aims to delineate the relative effectiveness between interscalene brachial plexus block with either intermediate cervical plexus or superficial cervical plexus block (CPB) as the anaesthetics for clavicular surgery.
DESIGN


A randomised, double-blind prospective study.
SETTING


Single-centre, tertiary care medical college and research institute.
PATIENTS


Fifty patients with American Society of Anesthesiologist's (ASA) grade I to III, aged 18 to 70 years, scheduled for clavicular surgery, during May 2018 to April 2019 were enrolled in this study.
INTERVENTION


All patients received interscalene block with 10 ml of 0.5% bupivacaine. Patients were randomised to undergo additional ultrasound-guided intermediate CPB (Group-1) or superficial CPB (Group-2) with 10 ml of 0.5% bupivacaine.
MAIN OUTCOME MEASURES


The block success rate, sensory block onset time, haemodynamic parameters, duration of postoperative analgesia and complications were noted. Categorical data were analysed using the chi-square test and Fisher's exact test. Continuous data were analysed using Student's t-test.
RESULT


In Group 1, block success was 100%. In Group 2, five patients failed to achieve adequate surgical anaesthesia (P = 0.02). The average sensory block onset time in Group 1 was 2.5 ± 0.4 min and was longer in Group 2, 4.3 ± 0.5 min (P < 0.001). There was no difference between the groups with respect to haemodynamic parameters and complications. The mean duration of postoperative analgesia was longer in Group 1 (7.5 ± 0.8 h) as compared with Group 2 (5.7 ± 0.4 h, P < 0.001).
CONCLUSION


Ultrasound-guided combined interscalene and intermediate CPB had a better success rate, with faster sensory block onset time and prolonged postoperative analgesia as compared with interscalene and superficial CPB in patients undergoing clavicle surgery.
TRIAL REGISTRATION


Clinical trial registry of India (www.ctri.nic.in) - CTRI/2018/05/013785.",2020,"The mean duration of postoperative analgesia was longer in Group 1 (7.5 ± 0.8 h) as compared with Group 2 (5.7 ± 0.4 h, P < 0.001).
","['clavicle surgery', 'Single-centre, tertiary care medical college and research institute', ""Fifty patients with American Society of Anesthesiologist's (ASA) grade I to III, aged 18 to 70 years, scheduled for clavicular surgery, during May 2018 to April 2019 were enrolled in this study"", 'patients undergoing clavicle surgery']","['interscalene block with 10\u200aml of 0.5% bupivacaine', 'Ultrasound-guided interscalene block combined with intermediate or superficial cervical plexus block', 'interscalene brachial plexus block with either intermediate cervical plexus or superficial cervical plexus block (CPB', 'interscalene and superficial CPB', 'additional ultrasound-guided intermediate CPB (Group-1) or superficial CPB (Group-2) with 10\u200aml of 0.5% bupivacaine', 'Ultrasound-guided combined interscalene and intermediate CPB']","['mean duration of postoperative analgesia', 'block success rate, sensory block onset time, haemodynamic parameters, duration of postoperative analgesia and complications', 'average sensory block onset time', 'adequate surgical anaesthesia', 'haemodynamic parameters and complications', 'block success']","[{'cui': 'C0008913', 'cui_str': 'Bone structure of clavicle'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035172', 'cui_str': 'Research Institutes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0394691', 'cui_str': 'Superficial cervical plexus block'}, {'cui': 'C0007854', 'cui_str': 'Cervical plexus structure'}, {'cui': 'C0394689', 'cui_str': 'Injection of anesthetic agent into cervical plexus'}, {'cui': 'C0589495', 'cui_str': 'Interscalene approach'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]",50.0,0.119153,"The mean duration of postoperative analgesia was longer in Group 1 (7.5 ± 0.8 h) as compared with Group 2 (5.7 ± 0.4 h, P < 0.001).
","[{'ForeName': 'B Krishna', 'Initials': 'BK', 'LastName': 'Arjun', 'Affiliation': 'Department of Anaesthesiology, Kempegowda Institute of Medical Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Chinnamaregowda N', 'Initials': 'CN', 'LastName': 'Vinod', 'Affiliation': ''}, {'ForeName': 'Jayanna', 'Initials': 'J', 'LastName': 'Puneeth', 'Affiliation': ''}, {'ForeName': 'Madappa C', 'Initials': 'MC', 'LastName': 'Narendrababu', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001300']
1391,32804742,Effect of pimavanserin on anxious depression in patients with major depression and an inadequate response to previous therapy: secondary analysis of the clarity study.,"In a post hoc analysis, the effect of pimavanserin on anxious depression was determined from CLARITY, a randomized, double-blind, placebo-controlled study in patients with major depression and an inadequate response to previous therapy. Patients were randomized in a 3:1 ratio to placebo or pimavanserin 34 mg daily added to ongoing antidepressant therapy. At 5 weeks, placebo nonresponders were rerandomized to placebo or pimavanserin for an additional 5 weeks. Mean change from baseline to week 5 for the Hamilton depression rating scale (HAMD) anxiety/somatization (AS) factor was examined for all patients and those with a score ≥7 at baseline. Least squares (LS) mean [standard error (SE)] difference between placebo and pimavanserin for the AS factor score was -1.5 (0.41) [95% confidence interval (CI) -2.4 to -0.7; P = 0.0003; effect size: 0.634]. Among patients with an AS factor score ≥7 at baseline, LS mean (SE) difference was -2.2 (0.66) (95% CI -3.5 to -0.9; P = 0.0013; effect size: 0.781). Response rates (≥50% reduction in HAMD-17 from baseline) were 22.4 and 55.2% (P = 0.0012) and remission rates (HAMD-17 total score <7) were 5.3 and 24.1% (P = 0.0047), respectively, with placebo and pimavanserin among patients with a baseline AS factor score ≥7. Among patients with anxious major depressive disorder at baseline, adjunctive pimavanserin was associated with a significant improvement.",2020,Mean change from baseline to week 5 for the Hamilton depression rating scale (HAMD) anxiety/somatization (AS) factor was examined for all patients and those with a score ≥7 at baseline.,"['patients with major depression and an inadequate response to previous therapy', 'patients with anxious major depressive disorder']","['placebo or pimavanserin', 'placebo and pimavanserin', 'pimavanserin', 'placebo']","['Least squares (LS) mean [standard error (SE)] difference', 'remission rates', 'Hamilton depression rating scale (HAMD) anxiety/somatization (AS) factor', 'anxious depression', 'Response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1722267', 'cui_str': 'pimavanserin'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}]",,0.419589,Mean change from baseline to week 5 for the Hamilton depression rating scale (HAMD) anxiety/somatization (AS) factor was examined for all patients and those with a score ≥7 at baseline.,"[{'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry and Behavioral Neurobiology, The University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, the University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Dirks', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, California, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, California, USA.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Stankovic', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, California, USA.'}]",International clinical psychopharmacology,['10.1097/YIC.0000000000000328']
1392,32805700,"The effect of circadian-adjusted LED-based lighting on sleep, daytime sleepiness and biomarkers of inflammation in a randomized controlled cross-over trial by pragmatic design in elderly care home dwellers.","AIM


Elderly multimorbid care home dwellers are a heterogenic group of frail individuals that exhibit sleep disturbances and a range of co-morbidities. The project aimed to study the possible effect of indoor circadian-adjusted LED-lighting (CaLED) in the elderly residents' care home on their sleeping patterns and systemic biomarkers associated with inflammation.
METHODS


A 16-week trial study was performed to follow the intervention and control groups using the Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) to monitor sleep and daytime sleepiness, and biomarkers IL-6, TNF-α and suPAR, to estimate the levels of inflammation.
RESULTS


There was no significant impact on sleep improvement after the short intervention time when analyzing the PSQI and ESS results. However, we found several challenges using these tools for this specific group of individuals. Thus, important knowledge was gained for future studies in elderly care home dwellers. The inflammation state throughout the entire study period was stable for most of the elderly and no significant change was detected from before to after the intervention. This study represents a first-to-date attempt to ameliorate the adverse effects of sleep disturbances that characterize a randomly chosen group of elderly multimorbid subjects, by using circadian-adjusted LED-lighting in a natural care home environment.
CONCLUSION


In this pragmatic randomized study of home dwelling individuals we were not able to demonstrate an improved sleep pattern as judged by PSQI, ESS or a change in inflammatory state.",2020,The inflammation state throughout the entire study period was stable for most of the elderly and no significant change was detected from before to after the intervention.,"['elderly care home dwellers', ""elderly residents' care home on their sleeping patterns and systemic biomarkers associated with inflammation"", 'elderly multimorbid subjects, by using circadian-adjusted LED-lighting in a natural care home environment', 'Elderly multimorbid care home dwellers are a heterogenic group of frail individuals that exhibit sleep disturbances and a range of co-morbidities', 'home dwelling individuals']","['indoor circadian-adjusted LED-lighting (CaLED', 'circadian-adjusted LED-based lighting']","['sleep improvement', 'inflammation state', 'sleep, daytime sleepiness and biomarkers of inflammation', 'Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) to monitor sleep and daytime sleepiness, and biomarkers IL-6, TNF-α and suPAR, to estimate the levels of inflammation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0167666,The inflammation state throughout the entire study period was stable for most of the elderly and no significant change was detected from before to after the intervention.,"[{'ForeName': 'Christine Borgen', 'Initials': 'CB', 'LastName': 'Linander', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: christine.borgen.linander@regionh.dk.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kallemose', 'Affiliation': 'The Emergency Department, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: thomas.kallemose@regionh.dk.'}, {'ForeName': 'Lillian Moerch', 'Initials': 'LM', 'LastName': 'Joergensen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark; The Emergency Department, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: lillian.moerch.joergensen@regionh.dk.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Andersen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark; The Emergency Department, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: ove.andersen@regionh.dk.'}, {'ForeName': 'Jan O', 'Initials': 'JO', 'LastName': 'Nehlin', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: jan.nehlin@regionh.dk.'}, {'ForeName': 'Baker Nawfal', 'Initials': 'BN', 'LastName': 'Jawad', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: baker.jawad@regionh.dk.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104223']
1393,32813947,Evinacumab for Homozygous Familial Hypercholesterolemia.,"BACKGROUND


Homozygous familial hypercholesterolemia is characterized by premature cardiovascular disease caused by markedly elevated levels of low-density lipoprotein (LDL) cholesterol. This disorder is associated with genetic variants that result in virtually absent (null-null) or impaired (non-null) LDL-receptor activity. Loss-of-function variants in the gene encoding angiopoietin-like 3 ( ANGPTL3 ) are associated with hypolipidemia and protection against atherosclerotic cardiovascular disease. Evinacumab, a monoclonal antibody against ANGPTL3, has shown potential benefit in patients with homozygous familial hypercholesterolemia.
METHODS


In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned in a 2:1 ratio 65 patients with homozygous familial hypercholesterolemia who were receiving stable lipid-lowering therapy to receive an intravenous infusion of evinacumab (at a dose of 15 mg per kilogram of body weight) every 4 weeks or placebo. The primary outcome was the percent change from baseline in the LDL cholesterol level at week 24.
RESULTS


The mean baseline LDL cholesterol level in the two groups was 255.1 mg per deciliter, despite the receipt of maximum doses of background lipid-lowering therapy. At week 24, patients in the evinacumab group had a relative reduction from baseline in the LDL cholesterol level of 47.1%, as compared with an increase of 1.9% in the placebo group, for a between-group least-squares mean difference of -49.0 percentage points (95% confidence interval [CI], -65.0 to -33.1; P<0.001); the between-group least-squares mean absolute difference in the LDL cholesterol level was -132.1 mg per deciliter (95% CI, -175.3 to -88.9; P<0.001). The LDL cholesterol level was lower in the evinacumab group than in the placebo group in patients with null-null variants (-43.4% vs. +16.2%) and in those with non-null variants (-49.1% vs. -3.8%). Adverse events were similar in the two groups.
CONCLUSIONS


In patients with homozygous familial hypercholesterolemia receiving maximum doses of lipid-lowering therapy, the reduction from baseline in the LDL cholesterol level in the evinacumab group, as compared with the small increase in the placebo group, resulted in a between-group difference of 49.0 percentage points at 24 weeks. (Funded by Regeneron Pharmaceuticals; ELIPSE HoFH ClinicalTrials.gov number, NCT03399786.).",2020,The LDL cholesterol level was lower in the evinacumab group than in the placebo group in patients with null-null variants (-43.4% vs. +16.2%) and in those with non-null variants (-49.1% vs. -3.8%).,"['patients with homozygous familial hypercholesterolemia receiving maximum doses of', '65 patients with homozygous familial hypercholesterolemia who were receiving stable lipid-lowering therapy to receive an', 'Homozygous Familial Hypercholesterolemia', 'patients with homozygous familial hypercholesterolemia']","['lipid-lowering therapy', 'intravenous infusion of evinacumab', 'Evinacumab', 'placebo']","['Adverse events', 'mean baseline LDL cholesterol level', 'LDL cholesterol level', 'low-density lipoprotein (LDL) cholesterol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0342881', 'cui_str': 'Familial hypercholesterolemia - homozygous'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}]","[{'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C4508522', 'cui_str': 'evinacumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",65.0,0.54859,The LDL cholesterol level was lower in the evinacumab group than in the placebo group in patients with null-null variants (-43.4% vs. +16.2%) and in those with non-null variants (-49.1% vs. -3.8%).,"[{'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Raal', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Rosenson', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Laurens F', 'Initials': 'LF', 'LastName': 'Reeskamp', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'G Kees', 'Initials': 'GK', 'LastName': 'Hovingh', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'John J P', 'Initials': 'JJP', 'LastName': 'Kastelein', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Rubba', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Poulabi', 'Initials': 'P', 'LastName': 'Banerjee', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Kuo-Chen', 'Initials': 'KC', 'LastName': 'Chan', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Gipe', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Nagwa', 'Initials': 'N', 'LastName': 'Khilla', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Weinreich', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gaudet', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2004215']
1394,32815077,The Effect of a General Healthy Lifestyle Intervention Delivered Around Pregnancy on Gestational Weight Gain and Infant Growth.,"OBJECTIVES


A life-course perspective emphasizes healthy behaviors before, during, and after pregnancy to support a multi-generational risk reduction in obesity for mothers and infants. Optimal timing, content, and dose of such interventions is not well defined.
METHODS


We conducted a nested cohort within a randomized trial to evaluate whether a healthy lifestyle intervention around pregnancy led to a ""spill-over effect,"" including a healthier rate (kg/week) of maternal gestational weight gain, and infant growth during the first year. Study enrollment began in 2012, follow-up data collection completed in 2018, and the data were analyzed in 2019. The intervention focused on healthy maternal diet and physical activity but not pregnancy weight or infant feeding. Outcome data were abstracted from electronic medical records.
RESULTS


Of the 165 women who became pregnant, 114 enrolled in the nested cohort. The average pre-pregnancy BMI was 29.6 (SD 5.1) kg/m 2 . Mixed effects models suggested clinically insignificant differences in both the rate of gestational weight gain (-0.02 kg/week; 95% CI -0.09, 0.06) and the rate of infant growth (difference at 1 year: -0.002 kg/cm; 95% CI -0.009, 0.005).
CONCLUSIONS FOR PRACTICE


A behavioral intervention that focused on overall maternal health delivered in the time around pregnancy did not result in a ""spill-over effect"" on healthy gestational weight gain or healthy infant growth during the first year of life.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT01316653.",2020,"Mixed effects models suggested clinically insignificant differences in both the rate of gestational weight gain (-0.02 kg/week; 95% CI -0.09, 0.06) and the rate of infant growth (difference at 1 year: -0.002 kg/cm; 95% CI -0.009, 0.005).
","['165 women who became pregnant', 'Study enrollment began in 2012, follow-up data collection completed in 2018, and the data were analyzed in 2019', 'mothers and infants', '114 enrolled in the nested cohort']","['General Healthy Lifestyle Intervention Delivered Around Pregnancy', 'healthy lifestyle intervention', 'healthy maternal diet and physical activity but not pregnancy weight or infant feeding']","['rate of gestational weight gain', 'maternal gestational weight gain, and infant growth', 'healthy gestational weight gain or healthy infant growth', 'Gestational Weight Gain and Infant Growth', 'average pre-pregnancy BMI', 'rate of infant growth', 'overall maternal health']","[{'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}]",,0.301696,"Mixed effects models suggested clinically insignificant differences in both the rate of gestational weight gain (-0.02 kg/week; 95% CI -0.09, 0.06) and the rate of infant growth (difference at 1 year: -0.002 kg/cm; 95% CI -0.009, 0.005).
","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Heerman', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, 2146 Belcourt Ave, 2nd Floor, Nashville, TN, 37212, USA. Bill.Heerman@vumc.org.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Samuels', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Barr', 'Affiliation': 'Vanderbilt University Medical School, Nashville, TN, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Burgess', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, 2146 Belcourt Ave, 2nd Floor, Nashville, TN, 37212, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Hartmann', 'Affiliation': 'Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Barkin', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, 2146 Belcourt Ave, 2nd Floor, Nashville, TN, 37212, USA.'}]",Maternal and child health journal,['10.1007/s10995-020-02998-0']
1395,32815101,Simultaneous en bloc endotracheal tube insertion with GlideScope® Titanium™ video laryngoscope use: a randomized-controlled trial.,"PURPOSE


Intubation-associated trauma with the GlideScope is rare, but when it occurs, it is likely due to advancing the endotracheal tube (ETT) blindly between the direct view of the oropharynx and the video view of the glottis. It is also occasionally difficult to advance the ETT to the glottic aperture despite a good view of the glottis on the monitor. One technique to potentially address both issues is to introduce the ETT en bloc with the GlideScope, thus visualizing the ETT tip throughout its entire path. We hypothesized that this en bloc technique could be faster and potentially easier than the standard technique.
METHODS


Fifty patients with normal-appearing airways who required orotracheal intubation for elective surgery were randomly allocated to intubation with either the en bloc or the standard (GlideScope-first-then-ETT) technique. A three-dimensional printed clip was utilized to secure the ETT to the GlideScope during en bloc insertion. The primary outcome was time to intubation, defined from mask removal to first end-tidal carbon dioxide detection, recorded by a blinded observer. Secondary outcomes were subjective ease of intubation (100-mm visual analogue scale [VAS], 0 = easy; 100 = difficult), number of intubation attempts/failures, and incidence of oropharyngeal trauma (bleeding).
RESULTS


The median [interquartile range (IQR)] intubation time was 36 [31-42] sec with the en bloc technique vs 41 [37-50] sec with the standard technique (difference in medians, 5 sec; 95% confidence interval [CI], 2 to 11; P = 0.008). The median [IQR] ease of intubation VAS was 11 [9-21] mm with the en bloc technique, and 15 [11-24] mm with the standard technique (difference in medians, 4 mm; 95% CI, -2 to 8; P = 0.19). Laryngoscopic grade and number of intubation attempts were similar between the groups; there was no oropharyngeal trauma noted.
CONCLUSION


In this study of video laryngoscopy, intubation was slightly faster with the en bloc technique than with the standard GlideScope intubation technique, although the clinical importance of this difference is unknown.
TRIAL REGISTRATION


www.clinicaltrials.gov (NCT02787629); registered 1 June 2016.",2020,"In this study of video laryngoscopy, intubation was slightly faster with the en bloc technique than with the standard GlideScope intubation technique, although the clinical importance of this difference is unknown.
",['Fifty patients with normal-appearing airways who required orotracheal intubation for elective surgery'],"['intubation with either the en bloc or the standard (GlideScope-first-then-ETT) technique', 'Simultaneous en bloc endotracheal tube insertion with GlideScope® Titanium']","['time to intubation, defined from mask removal to first end-tidal carbon dioxide detection', 'Laryngoscopic grade and number of intubation attempts', 'median [IQR] ease of intubation VAS', 'subjective ease of intubation (100-mm visual analogue scale [VAS], 0 = easy; 100 = difficult), number of intubation attempts/failures, and incidence of oropharyngeal trauma (bleeding', 'median [interquartile range (IQR', 'intubation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",50.0,0.120902,"In this study of video laryngoscopy, intubation was slightly faster with the en bloc technique than with the standard GlideScope intubation technique, although the clinical importance of this difference is unknown.
","[{'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Turkstra', 'Affiliation': 'Department of Anesthesia & Perioperative Medicine, Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Turkstra', 'Affiliation': 'Department of Mechanical Engineering, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Alexander W', 'Initials': 'AW', 'LastName': 'Pavlosky', 'Affiliation': 'Department of Family Medicine, Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Jones', 'Affiliation': 'Department of Anesthesia & Perioperative Medicine, Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01778-2']
1396,32819145,General Versus Local Anesthesia With Conscious Sedation in Transcatheter Aortic Valve Implantation: The Randomized SOLVE-TAVI Trial.,"BACKGROUND


In clinical practice, local anesthesia with conscious sedation (CS) is performed in roughly 50% of patients undergoing transcatheter aortic valve replacement. However, no randomized data assessing the safety and efficacy of CS versus general anesthesia (GA) are available.
METHODS


The SOLVE-TAVI (Comparison of Second-Generation Self-Expandable Versus Balloon-Expandable Valves and General Versus Local Anesthesia in Transcatheter Aortic Valve Implantation) trial is a multicenter, open-label, 2×2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement comparing CS versus GA. The primary efficacy end point was powered for equivalence (equivalence margin 10% with significance level 0.05) and consisted of the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury at 30 days.
RESULTS


The primary composite end point occurred in 27.2% of CS and 26.4% of GA patients (rate difference, 0.8 [90% CI, -6.2 to 7.8];  P equivalence =0.015). Event rates for the individual components were as follows: all-cause mortality, 3.2% versus 2.3% (rate difference, 1.0 [90% CI, -2.9 to 4.8];  P equivalence <0.001); stroke, 2.4% versus 2.8% (rate difference, -0.4 [90% CI, -3.8 to 3.8];  P equivalence <0.001); myocardial infarction, 0.5% versus 0.0% (rate difference, 0.5 [90% CI, -3.0 to 3.9];  P equivalence <0.001), infection requiring antibiotics 21.1% versus 22.0% (rate difference, -0.9 [90% CI, -7.5 to 5.7];  P equivalence =0.011); acute kidney injury, 9.0% versus 9.2% (rate difference, -0.2 [90% CI, -5.2 to 4.8];  P equivalence =0.0005). There was a lower need for inotropes or vasopressors with CS (62.8%) versus GA (97.3%; rate difference, -34.4 [90% CI, -41.0 to -27.8]).
CONCLUSIONS


Among patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement, use of CS compared with GA resulted in similar outcomes for the primary efficacy end point. These findings suggest that CS can be safely applied for transcatheter aortic valve replacement. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02737150.",2020,"Event rates for the individual components were as follows: all-cause mortality 3.2% versus 2.3% (rate difference 1.0 [90%CI - 2.9 to 4.8]; P equivalence <0.001), stroke 2.4% versus 2.8% (rate difference -0.4 [90%CI -3.8 to 3.8]; P equivalence <0.001), myocardial infarction 0.5% versus 0.0% (rate difference 0.5 [90%CI -3.0 to 3.9]; P equivalence <0.001), infection requiring antibiotics 21.1% versus 22.0% (rate difference -0.9","['447 patients with aortic stenosis undergoing transfemoral TAVR comparing CS versus GA', 'Transcatheter Aortic Valve Implantation', 'patients with aortic stenosis undergoing transfemoral TAVR, use of', 'patients undergoing transcatheter aortic valve replacement (TAVR']","['GA', 'local anesthesia with conscious sedation (CS', 'CS', 'Local Anesthesia with Conscious Sedation']","['infection requiring antibiotics', 'acute kidney injury', 'myocardial infarction', 'equivalence (equivalence margin 10% with significance level 0.05) and consisted of the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury at 30 days', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",447.0,0.244605,"Event rates for the individual components were as follows: all-cause mortality 3.2% versus 2.3% (rate difference 1.0 [90%CI - 2.9 to 4.8]; P equivalence <0.001), stroke 2.4% versus 2.8% (rate difference -0.4 [90%CI -3.8 to 3.8]; P equivalence <0.001), myocardial infarction 0.5% versus 0.0% (rate difference 0.5 [90%CI -3.0 to 3.9]; P equivalence <0.001), infection requiring antibiotics 21.1% versus 22.0% (rate difference -0.9","[{'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kurz', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Germany (T.K., I.E., C.M., R.M.-S., A.E.B., M.H., S.d.W.-T.).'}, {'ForeName': 'Hans-Josef', 'Initials': 'HJ', 'LastName': 'Feistritzer', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Stachel', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Hartung', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Lurz', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Eitel', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Germany (T.K., I.E., C.M., R.M.-S., A.E.B., M.H., S.d.W.-T.).'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Marquetand', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Germany (T.K., I.E., C.M., R.M.-S., A.E.B., M.H., S.d.W.-T.).'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Nef', 'Affiliation': 'Universitätsklinikum Marburg/Gießen, Gießen, Germany (H.N., O.D., U.V.-R.).'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Doerr', 'Affiliation': 'Universitätsklinikum Marburg/Gießen, Gießen, Germany (H.N., O.D., U.V.-R.).'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Vigelius-Rauch', 'Affiliation': 'Universitätsklinikum Marburg/Gießen, Gießen, Germany (H.N., O.D., U.V.-R.).'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lauten', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Germany (T.K., I.E., C.M., A.L., U.L., R.M.-S., N.F., I.R.K., S.D., S.d.W.-T.).'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Germany (T.K., I.E., C.M., A.L., U.L., R.M.-S., N.F., I.R.K., S.D., S.d.W.-T.).'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Treskatsch', 'Affiliation': 'Universitätsklinikum Charité, Campus Benjamin Franklin, Berlin, Germany (A.L., U.L., S.T.).'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Sandri', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Holzhey', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Borger', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Ender', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).'}, {'ForeName': 'Hüseyin', 'Initials': 'H', 'LastName': 'Ince', 'Affiliation': 'Universitätsklinikum Rostock, Germany (H.I., A.Ö.).'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Öner', 'Affiliation': 'Universitätsklinikum Rostock, Germany (H.I., A.Ö.).'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Meyer-Saraei', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Germany (T.K., I.E., C.M., R.M.-S., A.E.B., M.H., S.d.W.-T.).'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Hambrecht', 'Affiliation': 'Klinikum Links der Weser, Bremen, Germany (R.H., A.F., T.A.).'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fach', 'Affiliation': 'Klinikum Links der Weser, Bremen, Germany (R.H., A.F., T.A.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Augenstein', 'Affiliation': 'Klinikum Links der Weser, Bremen, Germany (R.H., A.F., T.A.).'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Frey', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Germany (T.K., I.E., C.M., A.L., U.L., R.M.-S., N.F., I.R.K., S.D., S.d.W.-T.).'}, {'ForeName': 'Inke R', 'Initials': 'IR', 'LastName': 'König', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Germany (T.K., I.E., C.M., A.L., U.L., R.M.-S., N.F., I.R.K., S.D., S.d.W.-T.).'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Vonthein', 'Affiliation': 'Institut für Medizinische Biometrie und Statistik, University of Lübeck, Germany (I.R.K., R.V.).'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Rückert', 'Affiliation': 'Leipzig Heart Institute, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., Y.R., A.-K.F., S.D.).'}, {'ForeName': 'Anne-Kathrin', 'Initials': 'AK', 'LastName': 'Funkat', 'Affiliation': 'Leipzig Heart Institute, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., Y.R., A.-K.F., S.D.).'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).'}, {'ForeName': 'Astrid E', 'Initials': 'AE', 'LastName': 'Berggreen', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Germany (T.K., I.E., C.M., R.M.-S., A.E.B., M.H., S.d.W.-T.).'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Heringlake', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Germany (T.K., I.E., C.M., R.M.-S., A.E.B., M.H., S.d.W.-T.).'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Germany (T.K., I.E., C.M., R.M.-S., A.E.B., M.H., S.d.W.-T.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.046451']
1397,32820334,Effect of dapagliflozin according to baseline systolic blood pressure in the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF).,"AIMS


Concern about hypotension often leads to withholding of beneficial therapy in patients with heart failure and reduced ejection fraction (HFrEF). We evaluated the efficacy and safety of dapagliflozin, which lowers systolic blood pressure (SBP),according to baseline SBP in Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF).
METHODS AND RESULTS


Key inclusion criteria were: New York Heart Association Class II-IV, left ventricular ejection fraction ≤ 40%, elevated N-terminal pro-B-type natriuretic peptide level, and SBP ≥95 mmHg. The primary outcome was a composite of worsening heart failure or cardiovascular death. The efficacy and safety of dapagliflozin were examined using SBP as both a categorical and continuous variable. A total of 1205 patients had a baseline SBP <110 mmHg; 981 ≥ 110 < 120; 1149 ≥ 120 < 130; and 1409 ≥ 130 mmHg. The placebo-corrected reduction in SBP from baseline to 2 weeks with dapagliflozin was -2.54 (-3.33 to -1.76) mmHg (P < 0.001), with a smaller between-treatment difference in patients in the lowest compared to highest SBP category. Patients in the lowest SBP category had a much higher rate (per 100 person-years) of the primary outcome [20.6, 95% confidence interval (95% CI) 17.6-24.2] than those in the highest SBP category (13.8, 11.7-16.4). The benefit and safety of dapagliflozin was consistent across the range of SBP; hazard ratio (95% CI) in each SBP group, lowest to highest: 0.76 (0.60-0.97), 0.76 (0.57-1.02), 0.81 (0.61-1.08), and 0.67 (0.51-0.87), P interaction = 0.78. Study drug discontinuation did not differ between dapagliflozin and placebo across the SBP categories examined.
CONCLUSION


Dapagliflozin had a small effect on SBP in patients with HFrEF and was superior to placebo in improving outcomes, and well tolerated, across the range of SBP included in DAPA-HF.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT03036124.",2020,"Dapagliflozin had a small effect on SBP in patients with HFrEF and was superior to placebo in improving outcomes, and well tolerated, across the range of SBP included in DAPA-HF.
","['Key inclusion criteria were: New York Heart Association Class II-IV, left ventricular ejection fraction ≤ 40%, elevated N-terminal pro-B-type natriuretic peptide level, and SBP ≥95\u2009mmHg', 'patients with heart failure and reduced ejection fraction (HFrEF', '1205 patients had a baseline SBP <110\u2009mmHg; 981\u2009≥\u2009110\u2009<\u2009120; 1149\u2009≥\u2009120\u2009<\u2009130; and 1409\u2009≥\u2009130\u2009mmHg']","['Dapagliflozin', 'dapagliflozin', 'dapagliflozin and placebo', 'placebo']","['composite of worsening heart failure or cardiovascular death', 'SBP', 'baseline systolic blood pressure', 'systolic blood pressure']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}]",1205.0,0.177517,"Dapagliflozin had a small effect on SBP in patients with HFrEF and was superior to placebo in improving outcomes, and well tolerated, across the range of SBP included in DAPA-HF.
","[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Serenelli', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Klinik für Innere Medizin III, Universität des Saarlandes, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'National University of Cordoba, Cordoba, Argentina.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics & Medical Informatics, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'Department of Cardiology, University of Minnesota, Minneaspolis, MN, USA.'}, {'ForeName': 'Chern-En', 'Initials': 'CE', 'LastName': 'Chiang', 'Affiliation': 'General Clinical Research Center and Division of Cardiology, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Chopra', 'Affiliation': 'Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India.'}, {'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'Department of Cardiology, University Medical Center and University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Diez', 'Affiliation': 'Division of Cardiology, Institute Cardiovascular de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Dukát', 'Affiliation': 'Department of Internal Medicine, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Department of Cardiology, Shanghai Institute of Cardiovascular Disease and Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Howlett', 'Affiliation': 'Cardiac Sciences and Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Tzvetana', 'Initials': 'T', 'LastName': 'Katova', 'Affiliation': 'Clinic of Cardiology, National Cardiology Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kitakaze', 'Affiliation': 'Cardiovascular Division of Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Charlotta E A', 'Initials': 'CEA', 'LastName': 'Ljungman', 'Affiliation': 'Department of Molecular and Clinical Medicine and Cardiology, Sahlgrenska Academy, Gothenburg, Sweden.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, ON, Canada.""}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}]",European heart journal,['10.1093/eurheartj/ehaa496']
1398,32820473,Influence of the Chelating Solutions in the Resistance of Glass Fiber Posts to the Root Dentin.,"OBJECTIVE


This study aimed to evaluate the influence of chelating agents (EDTA, citric acid and Tetraclean) on glass fiber posts adhesion to root dentin.
MATERIALS AND METHODS


Forty mandibular premolars single canals, with complete apical root, straight, circular cross sections were selected, accessed and had the cervical third prepared with Gates-Glidden drills, then included in resin, instrumented with ProTaper Universal and the root canal obturation was carried out. After, the samples were randomly divided into 4 groups (n = 10) to test the final irrigation solutions: G1:17% EDTA; G2:10% citric acid; G3: Tetraclean and G4: saline solution (control). After 30 days of storage (36.5° C and 100% humidity), the post preparation was performed leaving 4 mm of apical endodontic filling. Then, a fiber-glass post previously selected was coated with ED Primer adhesive system and resin sealer Panavia, installed and stored for 24 hours at 37°C. The samples were subjected to a tensile test with a constant speed of 1 mm/min with 2000 Kgf. The results were analyzed with the ANOVA test.
RESULTS


The statistical analyzes indicated no significant differences between the groups (p > 0.05).
CONCLUSION


The type of chelating agent used in the final irrigation of the endodontic treatment did not influence the tensile strength of the fixation system used to sealer the glass fiber posts to the intracanal dentin.",2020,The type of chelating agent used in the final irrigation of the endodontic treatment did not influence the tensile strength of the fixation system used to sealer the glass fiber posts to the intracanal dentin.,"['Forty mandibular premolars single canals, with complete apical root, straight, circular cross sections were selected, accessed and had the cervical third prepared with Gates-Glidden drills, then included in resin, instrumented with ProTaper Universal and the root canal obturation was carried out']","['chelating agents (EDTA, citric acid and Tetraclean', 'final irrigation solutions: G1:17% EDTA; G2:10% citric acid; G3: Tetraclean and G4: saline solution (control']",['tensile strength'],"[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C1282913', 'cui_str': 'Circular'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C4082130', 'cui_str': 'Prepared'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0035848', 'cui_str': 'Root canal obturation'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}]","[{'cui': 'C0007974', 'cui_str': 'Chelating agent'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C2974342', 'cui_str': 'Tetraclean'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1540845', 'cui_str': 'Tensile strength'}]",,0.0228196,The type of chelating agent used in the final irrigation of the endodontic treatment did not influence the tensile strength of the fixation system used to sealer the glass fiber posts to the intracanal dentin.,"[{'ForeName': 'Eduardo Fernandes', 'Initials': 'EF', 'LastName': 'Marques', 'Affiliation': 'Department of Endodontics, São Leopoldo Mandic Dental Research Center, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Marília Fagury Videira', 'Initials': 'MFV', 'LastName': 'Marceliano-Alves', 'Affiliation': 'Postgraduation Program, Iguaçu University, Nova Iguaçu, Brazil.'}, {'ForeName': 'Rina Andrea', 'Initials': 'RA', 'LastName': 'Pelegrine', 'Affiliation': 'Department of Endodontics, São Leopoldo Mandic Dental Research Center, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Sérgio Luiz', 'Initials': 'SL', 'LastName': 'Pinheiro', 'Affiliation': 'Department of Dentistry, Pontifícia Universidade Católica de Campinas (PUC-Campinas), São Paulo, Brazil.'}, {'ForeName': 'Carlos Eduardo Da Silveira', 'Initials': 'CEDS', 'LastName': 'Bueno', 'Affiliation': 'Department of Endodontics, São Leopoldo Mandic Dental Research Center, Campinas, São Paulo, Brazil.'}]",European journal of dentistry,['10.1055/s-0040-1714761']
1399,32824722,The Impact of a Multi-Pronged Intervention on Students' Perceptions of School Lunch Quality and Convenience and Self-Reported Fruit and Vegetable Consumption.,"School lunch programs provide an opportunity to improve students' diets. We sought to determine the impact of a multifaceted intervention (cafeteria redesigns, increased points-of-sale and teacher education) on secondary students' perceptions of school-lunch quality and convenience and fruit and vegetable intake. Surveys ( n  = 12,827) from middle and high school students in 12 intervention and 11 control schools were analyzed. We investigated change in school-lunch perceptions and lunchtime and daily fruit and vegetable consumption from 2016 to 2018. Among 8th graders, perceptions that school lunch tastes good and that school lunch was enough to make students feel full increased 0.2 points (on a 5-point scale;  p  < 0.01) in intervention schools relative to control schools. Among 10th graders, lunchtime fruit and vegetable consumption increased 6% in intervention relative to control schools ( p  < 0.05 and  p  < 0.01 respectively). Daily fruit intake increased 0.1 cups/day in intervention relative to control schools among 9th graders ( p  < 0.01). This study provides important evidence on the limited effect of design approaches in the absence of meal changes. We observed only modest changes in school lunch perceptions and fruit and vegetable consumption that were not consistent across grades, suggesting that additional efforts are needed to improve school-lunch uptake.",2020,Daily fruit intake increased 0.1 cups/day in intervention relative to control schools among 9th graders ( p  < 0.01).,"['Surveys ( n  = 12,827) from middle and high school students in 12 intervention and 11 control schools were analyzed', ""students' diets""]","['Multi-Pronged Intervention', 'multifaceted intervention (cafeteria redesigns, increased points-of-sale and teacher education']","['lunchtime fruit and vegetable consumption', 'school-lunch uptake', 'Daily fruit intake', 'school-lunch perceptions and lunchtime and daily fruit and vegetable consumption', 'school lunch perceptions and fruit and vegetable consumption', 'school-lunch quality and convenience and fruit and vegetable intake', 'School Lunch Quality and Convenience and Self-Reported Fruit and Vegetable Consumption']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036070', 'cui_str': 'Sales'}, {'cui': 'C0871930', 'cui_str': 'Teacher Education'}]","[{'cui': 'C0585039', 'cui_str': 'Lunch time'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0556227', 'cui_str': 'Fruit intake'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",,0.0183678,Daily fruit intake increased 0.1 cups/day in intervention relative to control schools among 9th graders ( p  < 0.01).,"[{'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': 'Machado', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA 94704, USA.'}, {'ForeName': 'Lorrene D', 'Initials': 'LD', 'LastName': 'Ritchie', 'Affiliation': 'Nutrition Policy Institute, University of California Agriculture and Natural Resources, Berkeley, CA 94704, USA.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Thompson', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA 94704, USA.'}, {'ForeName': 'Kristine A', 'Initials': 'KA', 'LastName': 'Madsen', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA 94704, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17165987']
1400,32824731,A Guide to Nature Immersion: Psychological and Physiological Benefits.,"Nature exposure has been renowned for its positive physiological and psychological benefits. Recent years have seen a rise in nature immersion programs that make use of Guided Forest Therapy walks in a standard sequence of sensory awareness activities to expose participants to natural environments in a safe but effective manner. The study aimed to compare the efficacy of guided versus unguided nature immersion, upon three dependent variables of mood, nature connectedness and heartrate. 51 participants were assigned to either guided or unguided nature immersion. Nature connectedness (Connectedness to Nature Scale, CNS), Environmental Identity Scale, EID short form) and mood (Positive and Negative Affect Scale, PANAS) were assessed before and after nature immersion, while heart rate was tracked continuously by a wristwatch heart rate tracker throughout the 2-h experience. Demographics and general health practice (GHP) information were also collected. A mixed model ANOVA revealed that nature connectedness and mood (but not heart rate) improved post-immersion for all participants. Comparing the guided/unguided conditions, there were no significant differences in the change in nature connectedness, mood or heart rate. Comparing within the five segments within the standard sequence in the guided condition, the third and fifth segments revealed a significantly lower heart rate compared to the baseline heart rate.",2020,"Comparing the guided/unguided conditions, there were no significant differences in the change in nature connectedness, mood or heart rate.",['51 participants'],"['guided or unguided nature immersion', 'guided versus unguided nature immersion']","['Nature connectedness (Connectedness to Nature Scale, CNS), Environmental Identity Scale, EID short form) and mood (Positive and Negative Affect Scale, PANAS', 'Demographics and general health practice (GHP) information', 'nature connectedness, mood or heart rate', 'heart rate']",[],"[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}]","[{'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",51.0,0.0195299,"Comparing the guided/unguided conditions, there were no significant differences in the change in nature connectedness, mood or heart rate.","[{'ForeName': 'Pei Yi', 'Initials': 'PY', 'LastName': 'Lim', 'Affiliation': 'Psychology Department, James Cook University, Singapore 387380, Singapore.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Dillon', 'Affiliation': 'Psychology Department, James Cook University, Singapore 387380, Singapore.'}, {'ForeName': 'Peter K H', 'Initials': 'PKH', 'LastName': 'Chew', 'Affiliation': 'Psychology Department, James Cook University, Singapore 387380, Singapore.'}]",International journal of environmental research and public health,['10.3390/ijerph17165989']
1401,32824771,High-Flow Oxygen through Nasal Cannula vs. Non-Invasive Ventilation in Hypercapnic Respiratory Failure: A Randomized Clinical Trial.,"High-flow oxygen through nasal cannula (HFNC) provides adequate oxygenation and can be an alternative to noninvasive ventilation (NIV) for patients with hypoxemic respiratory failure. The aim of the present study was to assess the efficacy of HFNC versus NIV in hypercapnic respiratory failure. Patients (n = 40) who were admitted to the Emergency Department of Alexandra Hospital due to hypercapnic respiratory failure (PaCO 2  ≥ 45 mmHg) were randomized assigned into two groups, i.e., an intervention group (use of HFNC, n = 20) and a control group (use of NIV, n = 20). During their hospitalization in the Intensive Care Unit, vital signs (respiratory and heart rate, arterial blood pressure) and arterial blood gases (ABG) were closely monitored on admission, after 24 h and at discharge. No difference between the two groups regarding the duration of hospitalization and the use of HFNC or NIV was observed ( p  > 0.05). On admission, the two groups did not differ in terms of gender, age, body mass index, APACHE score, predicted death rate, heart rate, arterial blood pressure and arterial blood gases ( p  > 0.05). Respiratory rate in the HFNC group was lower than in the NIV group ( p  = 0.023). At discharge, partial carbon dioxide arterial pressure (PaCO 2 ) in the HFNC group was lower than in the NIV group (50.8 ± 9.4 mmHg versus 59.6 ± 13.9 mmHg,  p  = 0.024). The lowerPaCO 2  in the HFNC group than in the NIV group indicated that HFNC was superior to NIV in the management of hypercapnic respiratory failure.",2020,The lowerPaCO 2  in the HFNC group than in the NIV group indicated that HFNC was superior to NIV in the management of hypercapnic respiratory failure.,"['patients with hypoxemic respiratory failure', '45 mmHg', 'Hypercapnic Respiratory Failure', 'hypercapnic respiratory failure', 'Patients (n = 40) who were admitted to the Emergency Department of Alexandra Hospital due to hypercapnic respiratory failure (PaCO 2  ≥']","['High-flow oxygen through nasal cannula (HFNC', 'High-Flow Oxygen through Nasal Cannula vs. Non-Invasive Ventilation', 'HFNC']","['partial carbon dioxide arterial pressure (PaCO 2 ', 'duration of hospitalization and the use of HFNC or NIV', 'vital signs (respiratory and heart rate, arterial blood pressure) and arterial blood gases (ABG', 'body mass index, APACHE score, predicted death rate, heart rate, arterial blood pressure and arterial blood gases', 'Respiratory rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0398353', 'cui_str': 'Hypercapnic respiratory failure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0243030', 'cui_str': 'Acute physiology and chronic health evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",,0.0542864,The lowerPaCO 2  in the HFNC group than in the NIV group indicated that HFNC was superior to NIV in the management of hypercapnic respiratory failure.,"[{'ForeName': 'Yiannis', 'Initials': 'Y', 'LastName': 'Papachatzakis', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Alexandra Hospital, 11527 Athens, Greece.'}, {'ForeName': 'Pantelis Theodoros', 'Initials': 'PT', 'LastName': 'Nikolaidis', 'Affiliation': 'Department of Occupational Therapy, School of Health and Caring Sciences, University of West Attica, 12243 Athens, Greece.'}, {'ForeName': 'Sofoklis', 'Initials': 'S', 'LastName': 'Kontogiannis', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Alexandra Hospital, 11527 Athens, Greece.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Trakada', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Alexandra Hospital, 11527 Athens, Greece.'}]",International journal of environmental research and public health,['10.3390/ijerph17165994']
1402,32842722,"The relative analgesic value of a femoral nerve block versus adductor canal block following total knee arthroplasty: a randomized, controlled, double-blinded study.","BACKGROUND


Multiple comparative studies report that adductor canal blocks provide similar pain relief to femoral nerve blocks following total knee arthroplasty. However, adductor canal blockade fails to anesthetize several important femoral nerve branches that contribute to knee innervation. We sought to clarify this anatomic discrepancy by performing both blocks in sequence, using patients as their own controls. We hypothesized that patients would experience additional pain relief following a superimposed femoral nerve block, demonstrating that these techniques are not equivalent.
METHODS


Sixteen patients received continuous adductor canal block before undergoing knee arthroplasty under general anesthesia. In the recovery room, patients reported their pain score on a numeric scale of 0-10. Once a patient reached a score of five or greater, he/she was randomized to receive an additional femoral nerve block using 2% chloroprocaine or saline sham, and pain scores recorded every 5 min for 30 min. Patients received opioid rescue as needed. Anesthesiologists performing and assessing block efficacy were blinded to group allocation.
RESULTS


Patients randomized to chloroprocaine versus saline reported significantly improved median pain scores 30 min after the femoral block (2.0 vs. 5.5, P = 0.0001). Patients receiving chloroprocaine also required significantly fewer morphine equivalents during the 30 min post-femoral block (1.0 vs. 4.5 mg, P = 0.03).
CONCLUSIONS


Adductor canal block is a useful technique for postoperative pain following total knee arthroplasty, but it does not provide equivalent analgesic efficacy to femoral nerve block. Future studies comparing efficacy between various block sites along the thigh are warranted.",2020,"Results


Patients randomized to chloroprocaine versus saline reported significantly improved median pain scores 30 minutes after the femoral block (2.0 vs. 5.5, p=0.0001).",['total knee arthroplasty'],"['additional femoral nerve block using 2% chloroprocaine', 'femoral nerve block versus adductor canal block', 'adductor canal blocks', 'continuous adductor canal block prior to undergoing total knee arthroplasty under general anesthesia', 'chloroprocaine']","['pain score', 'morphine equivalents', 'pain scores', 'median pain scores']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C0055443', 'cui_str': 'chloroprocaine'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.56845,"Results


Patients randomized to chloroprocaine versus saline reported significantly improved median pain scores 30 minutes after the femoral block (2.0 vs. 5.5, p=0.0001).","[{'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Gadsden', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Sata', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'W Michael', 'Initials': 'WM', 'LastName': 'Bullock', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Amanda H', 'Initials': 'AH', 'LastName': 'Kumar', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Grant', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Dooley', 'Affiliation': 'Department of Anesthesiology, University of North Carolina Medical Center, University of North Carolina, Chapel Hill, NC, USA.'}]",Korean journal of anesthesiology,['10.4097/kja.20269']
1403,32843703,Naltrexone modulates contextual processing in depression.,"Context, the information surrounding an experience, can significantly alter the meaning and the affective responses to events. Yet the biological mechanisms through which context modulate experiences are not entirely understood. Here, we hypothesized that the µ-opioid system-extensively implicated in placebo effects, a clinical phenomenon thought to rely on contextual processing-modulates the effects of contextual information on emotional attributions in patients with depression. To test this hypothesis, 20 unmedicated patients with depression completed a randomized, double-blind, placebo-controlled, crossover study of one dose of 50 mg of naltrexone, or placebo immediately before completing two sessions of the Contextual Framing fMRI task. This task captures effects of valenced contextual cues (pleasant vs. unpleasant) on emotional attribution (the rating of subtle emotional faces: fearful, neutral, or happy). Behaviorally, we found that emotional attribution was significantly moderated by the interaction between contextual cues and subtle emotional faces, such that participants' ratings of valenced faces (fearful and happy), compared to neutral, were more negative during unpleasant, compared to pleasant context cues. At a neural level, context-induced blood-oxygen-level-dependent responses in the ventromedial prefrontal cortex, the dorsal anterior cingulate, the dorsolateral prefrontal cortex, and the lateral orbitofrontal cortex, significantly moderated the effects of context on emotional attribution, and were blunted by naltrexone. Furthermore, the effects of naltrexone on emotional attribution were partially abolished in more severely depressed patients. Our results provide insights into the molecular alterations underlying context representation in patients with depression, providing pivotal early data for future treatment studies.",2020,"At a neural level, context-induced blood-oxygen-level-dependent responses in the ventromedial prefrontal cortex, the dorsal anterior cingulate, the dorsolateral prefrontal cortex, and the lateral orbitofrontal cortex, significantly moderated the effects of context on emotional attribution, and were blunted by naltrexone.","['patients with depression', '20 unmedicated patients with depression', 'depression']","['placebo', 'Naltrexone', 'naltrexone, or placebo', 'naltrexone', 'valenced contextual cues (pleasant vs. unpleasant']","[""contextual cues and subtle emotional faces, such that participants' ratings of valenced faces (fearful and happy"", 'emotional attribution']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}]",20.0,0.0755192,"At a neural level, context-induced blood-oxygen-level-dependent responses in the ventromedial prefrontal cortex, the dorsal anterior cingulate, the dorsolateral prefrontal cortex, and the lateral orbitofrontal cortex, significantly moderated the effects of context on emotional attribution, and were blunted by naltrexone.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mizuno', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lyew', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'H T', 'Initials': 'HT', 'LastName': 'Karim', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Dombrovski', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peciña', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA. pecinam@upmc.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00809-2']
1404,32816320,Primaquine alternative dosing schedules for preventing malaria relapse in people with Plasmodium vivax.,"BACKGROUND


Plasmodium vivax liver stages (hypnozoites) may cause relapses, prolonging morbidity, and impeding malaria control and elimination. The World Health Organization (WHO) recommends three schedules for primaquine: 0.25 mg/kg/day (standard), or 0.5 mg/kg/day (high standard) for 14 days, or 0.75 mg/kg once weekly for eight weeks, all of which can be difficult to complete. Since primaquine can cause haemolysis in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency, clinicians may be reluctant to prescribe primaquine without G6PD testing, and recommendations when G6PD status is unknown must be based on an assessment of the risks and benefits of prescribing primaquine. Alternative safe and efficacious regimens are needed.
OBJECTIVES


To assess the efficacy and safety of alternative primaquine regimens for radical cure of P vivax malaria compared to the standard or high-standard 14-day courses.
SEARCH METHODS


We searched the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (PubMed); Embase (Ovid); LILACS (BIREME); WHO International Clinical Trials Registry Platform and ClinicalTrials.gov up to 2 September 2019, and checked the reference lists of all identified studies.
SELECTION CRITERIA


Randomized controlled trials (RCTs) of adults and children with P vivax malaria using either chloroquine or artemisinin-based combination therapy plus primaquine at a total adult dose of at least 210 mg, compared with the WHO-recommended regimens of 0.25 or 0.5 mg/kg/day for 14 days.
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed trial eligibility and quality, and extracted data. We calculated risk ratios (RRs) with 95% confidence intervals (CIs) for dichotomous data. We grouped efficacy data according to length of follow-up, partner drug, and trial location. We analysed safety data where included.
MAIN RESULTS


0.5 mg/kg/day for seven days versus standard 0.25 mg/kg/day for 14 days There may be little or no difference in P vivax recurrences at six to seven months when using the same total dose (210 mg adult dose) over seven days compared to 14 days (RR 0.96, 95% CI 0.66 to 1.39; 4 RCTs, 1211 participants; low-certainty evidence). No serious adverse events were reported. We do not know if there is any difference in the number of adverse events resulting in discontinuation of primaquine (RR 1.04, 95% CI 0.15 to 7.38; 5 RCTs, 1427 participants) or in the frequency of anaemia (RR 3.00, 95% CI 0.12 to 72.91, 1 RCT, 240 participants) between the shorter and longer regimens (very low-certainty evidence). Three trials excluded people with G6PD deficiency; two did not provide this information. Pregnant and lactating women were either excluded or no details were provided. High-standard 0.5 mg/kg/day for 14 days versus standard 0.25 mg/kg/day for 14 days There may be little or no difference in P vivax recurrences at six months with 0.5 mg/kg/day primaquine for 14 days compared to 0.25 mg/kg/day for 14 days (RR 0.84 (95% CI 0.49 to 1.43; 2 RCTs, 677 participants, low-certainty evidence). No serious adverse events were reported. We do not know whether there is a difference in adverse events resulting in discontinuation of treatment with the high-standard dosage (RR 4.19, 95% CI 0.90 to 19.60; 1 RCT, 778 participants, very low-certainty evidence). People with G6PD deficiency and pregnant or lactating women were excluded. 0.75 mg/kg/week for eight weeks versus high-standard 0.5 mg/kg/day for 14 days We do not know whether weekly primaquine increases or decreases recurrences of P vivax compared to high-standard 0.5 mg/kg/day for 14 days, at 11 months' follow-up (RR 3.18, 95% CI 0.37 to 27.60; 1 RCT, 122 participants; very low-certainty evidence). No serious adverse events and no episodes of anaemia were reported. G6PD-deficient patients were not randomized but included in the weekly primaquine group (only one patient detected). 1 mg/kg/day for seven days versus high standard 0.5 mg/kg/day for 14 days There is probably little or no difference in P vivax recurrences at 12 months between 1.0 mg/kg/day primaquine for seven days and the high-standard 0.5 mg/kg/day for 14 days (RR 1.03, 95% CI 0.82 to 1.30; 2 RCTs, 2526 participants; moderate-certainty evidence). There may be moderate to large increase in serious adverse events in the 1.0 mg/kg/day primaquine for seven days compared with the high-standard 0.5 mg/kg/day for 14 days, during 42 days follow-up (RR 12.03, 95% CI 1.57 to 92.30; 1 RCT, 1872 participants, low-certainty evidence). We do not know if there is a difference between 1.0 mg/kg/day primaquine for seven days and high-standard 0.5 mg/kg/day for 14 days in adverse events that resulted in discontinuation of treatment (RR 2.50, 95% CI 0.49 to 12.87; 1 RCT, 2526 participants, very low-certainty evidence), nor if there is difference in frequency of anaemia by 42 days (RR 0.93, 95% CI 0.62 to 1.41; 2 RCTs, 2440 participants, very low-certainty evidence). People with G6PD deficiency were excluded. Other regimens Two RCTs evaluated other rarely-used doses of primaquine, one of which had very high loss to follow-up. Adverse events were not reported. People with G6PD deficiency and pregnant or lactating women were excluded.
AUTHORS' CONCLUSIONS


Trials available to date do not detect a difference in recurrence between the following regimens: 1) 0.5 mg/kg/day for seven days versus standard 0.25 mg/kg/day for 14 days; 2) high-standard 0.5 mg/kg/day for 14 days versus standard 0.25 mg/kg/day for 14 days; 3) 0.75 mg/kg/week for eight weeks versus high-standard 0.5 mg/kg/day for 14 days; 4) 1 mg/kg/day for seven days versus high-standard 0.5 mg/kg/day for 14 days. There were no differences detected in adverse events for Comparisons 1, 2 or 3, but there may be more serious adverse events with the high seven-day course in Comparison 4. The shorter regimen of 0.5 mg/kg/day for seven days versus standard 0.25 mg/kg/day for 14 days may suit G6PD-normal patients. Further research will help increase the certainty of the findings and applicability in different settings.",2020,"We do not know whether there is a difference in adverse events resulting in discontinuation of treatment with the high-standard dosage (RR 4.19, 95% CI 0.90 to 19.60; 1 RCT, 778 participants, very low-certainty evidence).","['G6PD-deficient patients', 'Pregnant and lactating women', 'individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency', 'People with G6PD deficiency were excluded', 'People with G6PD deficiency and pregnant or lactating women were excluded', 'adults and children with P vivax malaria using either', 'People with G6PD deficiency and pregnant or lactating women', 'people with Plasmodium vivax']","['primaquine', 'Primaquine', 'chloroquine or artemisinin-based combination therapy plus primaquine']","['malaria relapse', 'P vivax recurrences', 'recurrences of P vivax', 'radical cure of P vivax malaria', 'Adverse events', 'efficacy and safety', 'serious adverse events', 'serious adverse events and no episodes of anaemia', 'adverse events', 'frequency of anaemia', 'calculated risk ratios (RRs']","[{'cui': 'C0017757', 'cui_str': 'Glucose-6-phosphate dehydrogenase'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2939465', 'cui_str': 'Deficiency of glucose-6-phosphate dehydrogenase'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0858321', 'cui_str': 'Plasmodium vivax infection'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0032154', 'cui_str': 'Plasmodium vivax'}]","[{'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0746365', 'cui_str': 'Malaria relapse'}, {'cui': 'C0858321', 'cui_str': 'Plasmodium vivax infection'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",2526.0,0.184528,"We do not know whether there is a difference in adverse events resulting in discontinuation of treatment with the high-standard dosage (RR 4.19, 95% CI 0.90 to 19.60; 1 RCT, 778 participants, very low-certainty evidence).","[{'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Milligan', 'Affiliation': 'Cochrane Infectious Diseases Group, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Daher', 'Affiliation': 'Vice-Presidency of Research and Biological Collections, Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, Brazil.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Villanueva', 'Affiliation': 'Cochrane Response, Cochrane, London, UK.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Bergman', 'Affiliation': 'Cochrane Response, Cochrane, London, UK.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Graves', 'Affiliation': 'College of Public Health, Medical and Veterinary Sciences, James Cook University, Cairns, Australia.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012656.pub3']
1405,32815416,"Anti-Thrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC): Study design and methodology for an international, adaptive Bayesian randomized controlled trial.","BACKGROUND


Mortality from COVID-19 is high among hospitalized patients and effective therapeutics are lacking. Hypercoagulability, thrombosis and hyperinflammation occur in COVID-19 and may contribute to severe complications. Therapeutic anticoagulation may improve clinical outcomes through anti-thrombotic, anti-inflammatory and anti-viral mechanisms. Our primary objective is to evaluate whether therapeutic-dose anticoagulation with low-molecular-weight heparin or unfractionated heparin prevents mechanical ventilation and/or death in patients hospitalized with COVID-19 compared to usual care.
METHODS


An international, open-label, adaptive randomized controlled trial. Using a Bayesian framework, the trial will declare results as soon as pre-specified posterior probabilities for superiority, futility, or harm are reached. The trial uses response-adaptive randomization to maximize the probability that patients will receive the more beneficial treatment approach, as treatment effect information accumulates within the trial. By leveraging a common data safety monitoring board and pooling data with a second similar international Bayesian adaptive trial (REMAP-COVID anticoagulation domain), treatment efficacy and safety will be evaluated as efficiently as possible. The primary outcome is an ordinal endpoint with three possible outcomes based on the worst status of each patient through day 30: no requirement for invasive mechanical ventilation, invasive mechanical ventilation or death.
CONCLUSION


Using an adaptive trial design, the Anti-Thrombotic Therapy To Ameliorate Complications of COVID-19 trial will establish whether therapeutic anticoagulation can reduce mortality and/or avoid the need for mechanical ventilation in patients hospitalized with COVID-19. Leveraging existing networks to recruit sites will increase enrollment and mitigate enrollment risk in sites with declining COVID-19 cases.",2020,"Using a Bayesian framework, the trial will declare results as soon as pre-specified posterior probabilities for superiority, futility, or harm are reached.","['patients hospitalized with COVID-19 compared to usual care', 'patients hospitalized with COVID-19']","['ATTACC', 'low-molecular-weight heparin or unfractionated heparin']","['mechanical ventilation and/or death', 'worst status of each patient through day 30: no requirement for invasive mechanical ventilation, invasive mechanical ventilation or death', 'Complications of COVID-19']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",,0.254399,"Using a Bayesian framework, the trial will declare results as soon as pre-specified posterior probabilities for superiority, futility, or harm are reached.","[{'ForeName': 'Brett L', 'Initials': 'BL', 'LastName': 'Houston', 'Affiliation': 'Max Rady Faculty of Health Sciences, Max Rady College of Medicine, Department of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Lawler', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ewan C', 'Initials': 'EC', 'LastName': 'Goligher', 'Affiliation': 'Toronto General Hospital Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Farkouh', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Bradbury', 'Affiliation': 'Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Dzavik', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fergusson', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Fowler', 'Affiliation': 'Department of Medicine, Sunnybrook Health Sciences Centre and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jean-Phillippe', 'Initials': 'JP', 'LastName': 'Galanaud', 'Affiliation': 'Department of Medicine, Sunnybrook Health Sciences Centre and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Gross', 'Affiliation': 'Thrombosis and Atherosclerosis Research Institute, Department of Medicine, McMaster University & Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Clinical Practice Assessment Unit, Department of Medicine, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Kahn', 'Affiliation': 'Center for Clinical Epidemiology, Jewish General Hospital/Lady Davis Institute, Division of Internal Medicine, Department of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Max Rady Faculty of Health Sciences, Max Rady College of Medicine, Department of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': ""Department of Surgery, St Michael's Hospital and the University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': 'The University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Arthur S', 'Initials': 'AS', 'LastName': 'Slutsky', 'Affiliation': ""Keenan Research Centre at the Li Ka Shing Knowledge Institute, St. Michael's Hospital and Departments of Medicine, Surgery, and Biomedical Engineering, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Alexis F', 'Initials': 'AF', 'LastName': 'Turgeon', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, Faculty of Medicine, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants, LLC, Austin, TX, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Rosenson', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Mount Sinai Hospital, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Escobedo', 'Affiliation': 'Medical Research Unit on Clinical Epidemiology, Mexican Social Security Institute, Mexico City, Mexico.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Bond', 'Affiliation': 'Ozmosis Research Inc., Toronto, ON, Canada.'}, {'ForeName': 'Bridget-Anne', 'Initials': 'BA', 'LastName': 'Kirwan', 'Affiliation': 'Department of Clinical Research, SOCAR Research SA, Nyon, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'de Brouwer', 'Affiliation': 'Department of Clinical Research, SOCAR Research SA, Nyon, Switzerland.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'Max Rady Faculty of Health Sciences, Max Rady College of Medicine, Department of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada.'}]","Clinical trials (London, England)",['10.1177/1740774520943846']
1406,32817701,Within-trial cost-effectiveness of lifestyle intervention using a 3-tier shared care approach for pregnancy outcomes in Chinese women with gestational diabetes.,"This study assessed within-trial cost-effectiveness of a shared care program (SC, n = 339) for pregnancy outcomes compared to usual care (UC, n = 361), as implemented in a randomized trial of Chinese women with gestational diabetes (GDM). SC consisted of an individualized dietary advice and physical activity counseling program. The UC was a one-time group education program. The effectiveness was measured by number needed to treat (NNT) to prevent one macrosomia/large for gestational age (LGA) infant. The cost-effectiveness was measured by incremental cost-effectiveness ratio in terms of cost (2012 Chinese Yuan/US dollar) per case of macrosomia and LGA prevented. The study took both a health care system and a societal perspective. This study found that the NNT was 16/14 for macrosomia/LGA. The incremental cost for treating a pregnant woman was ¥1,877 ($298) from a health care system perspective and ¥2,056 ($327) from a societal perspective. The cost of preventing a case of macrosomia/LGA from the two corresponding perspectives were ¥30,032/¥26,278 ($4,775/$4,178) and ¥32,896/¥28,784 ($5,230/$4,577), respectively. Considering the potential severe adverse health and economic consequences of a macrosomia/LGA infant, our findings suggest that implementing this lifestyle intervention for women with GDM is an efficient use of health care resources.",2020,"This study assessed within-trial cost-effectiveness of a shared care program (SC, n = 339) for pregnancy outcomes compared to usual care (UC, n = 361), as implemented in a randomized trial of Chinese women with gestational diabetes (GDM).","['women with GDM', 'Chinese women with gestational diabetes (GDM', 'Chinese women with gestational diabetes', 'pregnant woman was ¥1,877 ($298) from a health care system perspective and ¥2,056 ($327) from a societal perspective']","['NNT', 'shared care program (SC', 'lifestyle intervention using a 3-tier shared care approach', 'individualized dietary advice and physical activity counseling program']","['cost-effectiveness', 'cost of preventing a case of macrosomia/LGA']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]","[{'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}]",,0.0234859,"This study assessed within-trial cost-effectiveness of a shared care program (SC, n = 339) for pregnancy outcomes compared to usual care (UC, n = 361), as implemented in a randomized trial of Chinese women with gestational diabetes (GDM).","[{'ForeName': 'Weiqin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Cuiping', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Leng', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Shao', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Huiguang', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Fuxia', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Population Cancer Research Program and Department of Pediatrics, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Juliana C N', 'Initials': 'JCN', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine and Therapeutics, Hong Kong Institute of Diabetes and Obesity and The Chinese University of Hong Kong-Prince of Wales Hospital-International Diabetes Federation Centre of Education, Hong Kong SAR, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': 'Chronic Disease Epidemiology Laboratory, Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States of America.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Xilin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}]",PloS one,['10.1371/journal.pone.0237738']
1407,32817703,Effect of ventilation rate on recovery after cardiac arrest in a pediatric animal model.,"AIMS


To assess the impact of two different respiratory rates in hemodynamic, perfusion and ventilation parameters in a pediatric animal model of cardiac arrest (CA).
METHODS


An experimental randomized controlled trial was carried out in 50 piglets under asphyxial CA. After ROSC, they were randomized into two groups: 20 and 30 respirations per minute (rpm). Hemodynamic, perfusion and ventilation parameters were measured 10 minutes after asphyxia, just before ROSC and at 5, 15, 30 and 60 minutes after ROSC. Independent medians test, Kruskal-Wallis test and χ2 test, were used to compare continuous and categorical variables, respectively. Spearman's Rho was used to assess correlation between continuous variables. A p-value <0.05 was considered significant.
RESULTS


Arterial partial pressure of carbon dioxide (PaCO2) was significantly lower in the 30 rpm group after 15 minutes (41 vs. 54.5 mmHg, p <0.01), 30 minutes (39.5 vs. 51 mmHg, p < 0.01) and 60 minutes (36.5 vs. 48 mmHg, p = 0.02) of ROSC. The percentage of normoventilated subjects (PaCO2 30-50 mmHg) was significantly higher in the 30 rpm group throughout the experiment. pH normalization occurred faster in the 30 rpm group with significant differences at 60 minutes (7.40 vs. 7.34, p = 0.02). Lactic acid levels were high immediately after ROSC in both groups, but were significantly lower in the 20 rpm group at 30 (3.7 vs. 4.7 p = 0.04) and 60 minutes (2.6 vs. 3.6 p = 0.03).
CONCLUSIONS


This animal model of asphyxial CA shows that a respiratory rate of 30 rpm is more effective to reach normoventilation than 20 rpm in piglets after ROSC. This ventilation strategy seems to be safe, as it does not cause hyperventilation and does not affect hemodynamics or cerebral tissue perfusion.",2020,"Lactic acid levels were high immediately after ROSC in both groups, but were significantly lower in the 20 rpm group at 30 (3.7 vs. 4.7 p = 0.04) and 60 minutes (2.6 vs. 3.6 p = 0.03).
",['50 piglets under asphyxial CA'],['ventilation rate'],"['Arterial partial pressure of carbon dioxide (PaCO2', 'Lactic acid levels', 'pH normalization', 'Hemodynamic, perfusion and ventilation parameters']","[{'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.046131,"Lactic acid levels were high immediately after ROSC in both groups, but were significantly lower in the 20 rpm group at 30 (3.7 vs. 4.7 p = 0.04) and 60 minutes (2.6 vs. 3.6 p = 0.03).
","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'López', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañón General University Hospital, Madrid, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Arias', 'Affiliation': 'School of Medicine, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Domenech', 'Affiliation': 'School of Medicine, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Horcajo', 'Affiliation': 'School of Medicine, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Nocete', 'Affiliation': 'Gregorio Marañón Health Research Institute, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zamora', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañón General University Hospital, Madrid, Spain.'}, {'ForeName': 'Sarah Nicole', 'Initials': 'SN', 'LastName': 'Fernández', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañón General University Hospital, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'López-Herce', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañón General University Hospital, Madrid, Spain.'}]",PloS one,['10.1371/journal.pone.0237736']
1408,32822131,Editorial Comment: Flexible ureterorenoscopy and laser lithotripsy with regional anesthesia vs general anesthesia: A prospective randomized study.,,2020,,[],"['Flexible ureterorenoscopy and laser lithotripsy with regional anesthesia vs general anesthesia', 'Editorial Comment']",[],[],"[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}]",[],,0.018115,,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Denstedt', 'Affiliation': 'Division of Urology, Western University, Ontario, Canada.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2019.0770.1']
1409,32822130,Flexible ureterorenoscopy and laser lithotripsy with regional anesthesia vs general anesthesia: A prospective randomized study.,"PURPOSE


To compare the effect of general anesthesia (GA) and regional anesthesia (RA) on f-URS outcomes and surgeon comfort.
MATERIAL AND METHODS


The study was conducted between June 2017 to January 2018 and data collection was applied in a prospective, randomized fashion. 120 patients participated in the study and were divided into RA group (n=56) and GA group (n=64). Demographic, operative and post-operative parameters of patients were analysed. The end point of this study was the effect of two anesthesia regimens on the comfort of the surgeon, and the comparability of feasibility and safety against perioperative complications.
RESULTS


The study including 120 randomized patients, 14 patients were excluded from the study and completed with 106 patients (45 in RA group and 61 in GA group). No difference was detected between the two groups in terms of preoperative data. During the monitorization of operative vital signs, 3 patients in RA group experienced bradycardia, and this finding was significant when compared with GA group (p=0.041). Additionally, 2 patients in RA group experienced mucosal tears and 1 patient experienced hemorrhage during the operation, but no complications were observed in the GA group (p=0.041). Postoperative surgeon comfort evaluation revealed statistically significant results in favor of GA group (p=0.001).
CONCLUSIONS


Both GA and RA are equally effective and safe anesthesia methods for f-URS procedures. However, RA group showed significantly increased likelihood of bradycardia and mucosal injury during surgery, and significantly decreased surgeon comfort during surgery.",2020,"Postoperative surgeon comfort evaluation revealed statistically significant results in favor of GA group (p=0.001).
","['June 2017 to January 2018 and data collection', '120 randomized patients, 14 patients were excluded from the study and completed with 106 patients (45 in RA group and 61 in GA group', '120 patients participated in the study and were divided into RA group (n=56) and GA group (n=64']","['general anesthesia (GA) and regional anesthesia (RA', 'Flexible ureterorenoscopy and laser lithotripsy with regional anesthesia vs general anesthesia']","['bradycardia', 'likelihood of bradycardia and mucosal injury', 'surgeon comfort', 'mucosal tears and 1 patient experienced hemorrhage']","[{'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}]","[{'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",120.0,0.0376006,"Postoperative surgeon comfort evaluation revealed statistically significant results in favor of GA group (p=0.001).
","[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Sahan', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Sarilar', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mehmet Fatih', 'Initials': 'MF', 'LastName': 'Akbulut', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Eren', 'Initials': 'E', 'LastName': 'Demir', 'Affiliation': 'Department of Anesthesiology and Reanimation, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Metin', 'Initials': 'M', 'LastName': 'Savun', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Oznur', 'Initials': 'O', 'LastName': 'Sen', 'Affiliation': 'Department of Anesthesiology and Reanimation, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Faruk', 'Initials': 'F', 'LastName': 'Ozgor', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2019.0770']
1410,32822141,"Editorial Comment: Ultra-hypofractionated versus conventionally fractionated radiothe-rapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial.",,2020,,['prostate cancer'],['Editorial Comment: Ultra-hypofractionated versus conventionally fractionated radiothe-rapy'],[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0282411', 'cui_str': 'Editorial Comment'}]",[],,0.109669,,"[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lott', 'Affiliation': 'Instituto Nacional do Câncer - INCA, Rio de Janeiro, RJ, Brasil.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2020.06.09']
1411,32824394,"Effects of Virtual Reality versus Exercise on Pain, Functional, Somatosensory and Psychosocial Outcomes in Patients with Non-specific Chronic Neck Pain: A Randomized Clinical Trial.","Background : Virtual reality (VR) applied to patients with neck pain is a promising intervention to produce positive effects when used alone or combined with exercise. Therefore, the objective of this manuscript is to compare the effects of VR versus exercise treatment on pain intensity, conditioned pain modulation (CPM), temporal summation (TS) and functional and somatosensory outcomes in patients with non-specific chronic neck pain (NS-CNP).  Methods : A single-blinded, randomized clinical trial was carried out. A total sample of 44 patients with NS-CNP was randomized into a VR treatment group or neck exercises group. The intervention consisted of two treatment sessions per week, for four weeks and eight sessions. Four measurement moments (at baseline, immediately, 1 month, and 3 months after intervention) were considered. Pain intensity, CPM, TS, functional and somatosensory outcomes were measured.  Results : Statistically significant differences were revealed for time factor (F = 16.40,  p  < 0.01, η p 2  = 0.28) and group*time interaction for kinesiophobia (F = 3.89,  p  = 0.01, η p 2  = 0.08) showing post-hoc differences in favor of the VR group at 3 months ( p  < 0.05, d = 0.65). Significant effects were shown for time factor ( p  < 0.05) but not for the group*time interaction ( p  > 0.05) for pain intensity, rotation range of motion (ROM), Neck Disability Index, pain catastrophizing, fear-avoidance beliefs, left side pressure pain threshold (PPT) and anxiety. Statistically significant differences were not found for time factor ( p  > 0.05) and neither in group*time interaction ( p  > 0.05) for CPM, TS, right side PPT, flexo-extension and lateral-flexion ROM.  Conclusions : Kinesiophobia was the only outcome that showed differences between VR and exercise at 3 months. Nevertheless, pain intensity, CPM, TS, ROM, neck disability, pain catastrophizing, fear-avoidance beliefs, PPT and anxiety did not show differences between both interventions.",2020,"Statistically significant differences were not found for time factor ( p  > 0.05) and neither in group*time interaction ( p  > 0.05) for CPM, TS, right side PPT, flexo-extension and lateral-flexion ROM.  ","['Patients with Non-specific Chronic Neck Pain', 'patients with non-specific chronic neck pain (NS-CNP', '44 patients with NS-CNP', 'patients with neck pain']","[' ', 'Kinesiophobia', 'Virtual Reality versus Exercise', 'Virtual reality (VR', 'VR treatment group or neck exercises group', 'VR versus exercise']","['CPM, TS, right side PPT, flexo-extension and lateral-flexion ROM', 'pain intensity, CPM, TS, ROM, neck disability, pain catastrophizing, fear-avoidance beliefs, PPT and anxiety', 'pain intensity, rotation range of motion (ROM), Neck Disability Index, pain catastrophizing, fear-avoidance beliefs, left side pressure pain threshold (PPT) and anxiety', 'time factor', 'group*time interaction for kinesiophobia', 'pain intensity, conditioned pain modulation (CPM), temporal summation (TS) and functional and somatosensory outcomes', 'Pain intensity, CPM, TS, functional and somatosensory outcomes', 'Pain, Functional, Somatosensory and Psychosocial Outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]","[{'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0454347', 'cui_str': 'Neck exercises'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0040225', 'cui_str': 'Time Factors'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",44.0,0.113865,"Statistically significant differences were not found for time factor ( p  > 0.05) and neither in group*time interaction ( p  > 0.05) for CPM, TS, right side PPT, flexo-extension and lateral-flexion ROM.  ","[{'ForeName': 'David Morales', 'Initials': 'DM', 'LastName': 'Tejera', 'Affiliation': 'Escuela Internacional de Doctorado, Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, 28032 Alcorcón, Spain.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Beltran-Alacreu', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, 28043 Madrid, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cano-de-la-Cuerda', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine. Rey Juan Carlos University, 28922 Madrid, Spain.'}, {'ForeName': 'Jose Vicente', 'Initials': 'JV', 'LastName': 'Leon Hernández', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, 28043 Madrid, Spain.'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Martín-Pintado-Zugasti', 'Affiliation': 'Departamento de Fisioterapia, Facultad de Medicina, Universidad San Pablo-CEU, CEU Universities, Madrid 28008, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Calvo-Lobo', 'Affiliation': 'Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Gil-Martínez', 'Affiliation': 'CranioSpain Research Group, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, 28043 Madrid, Spain.'}, {'ForeName': 'Josué', 'Initials': 'J', 'LastName': 'Fernández-Carnero', 'Affiliation': 'CranioSpain Research Group, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, 28043 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17165950']
1412,32827458,Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and design of a cluster-randomized trial.,"BACKGROUND


The Systolic Blood Pressure Intervention Trial (SPRINT) reported that intensive blood pressure (BP) treatment reduced cardiovascular disease and mortality compared to standard BP treatment in hypertension patients. The next important question is how to implement more intensive BP treatment in real-world clinical practice. We designed an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multifaceted intervention for intensive BP treatment and its feasibility, fidelity, and sustainability in underserved hypertension patients.
METHODS


Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS) is a cluster randomized trial conducted in 36 Federally Qualified Health Center clinics in Louisiana and Mississippi. Federally Qualified Health Center clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care. Difference in mean systolic BP change from baseline to 18 months is the primary clinical effectiveness outcome, and intervention fidelity, measured by treatment intensification and medication adherence, is the primary implementation outcome. The planned sample size of 1,260 participants (36 clinics with 35 participants each) has 90% power to detect a 5.0-mm Hg difference in systolic BP at a .05 significance level and 80% follow-up rate.
CONCLUSIONS


IMPACTS will generate critical data on the effectiveness and implementation of a multifaceted intervention for intensive BP treatment in real-world clinical practice and could directly impact the BP-related disease burden in minority and low-income populations in the United States.",2020,"FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care.","['hypertension patients', '36 Federally Qualified Health Center (FQHC) clinics in Louisiana and Mississippi', 'FQHC clinics', 'underserved hypertension patients', '1,260 participants (36 clinics with 35 participants each']","['Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS', 'multifaceted intervention', 'multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care', 'intensive blood pressure (BP']","['feasibility, fidelity, and sustainability', 'systolic BP', 'mean systolic BP change', 'cardiovascular disease and mortality']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0024024', 'cui_str': 'Louisiana'}, {'cui': 'C0026221', 'cui_str': 'Mississippi'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1272452', 'cui_str': 'Blood pressure taking management'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1260.0,0.0928859,"FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care.","[{'ForeName': 'Katherine T', 'Initials': 'KT', 'LastName': 'Mills', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Peacock', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, New Orleans, LA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Department of Medicine, Tulane University School of Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Brooks', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Cyprian', 'Affiliation': 'Southeast Community Health Systems, Greensburg, LA.'}, {'ForeName': 'Gerrelda', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': 'Louisiana Primary Care Association, Baton Rouge, LA.'}, {'ForeName': 'Sonja R', 'Initials': 'SR', 'LastName': 'Fuqua', 'Affiliation': 'Community Health Center Association of Mississippi, Jackson, MS.'}, {'ForeName': 'Angelique', 'Initials': 'A', 'LastName': 'Greer', 'Affiliation': 'Coastal Family Health Center, Biloxi, MS.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Gray-Winfrey', 'Affiliation': 'EXCELth, Inc., New Orleans, LA.'}, {'ForeName': 'Shondra', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'InclusivCare, Avondale, LA.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Wiltz', 'Affiliation': 'Teche Action Board, Inc., Franklin, LA.'}, {'ForeName': 'Keith L', 'Initials': 'KL', 'LastName': 'Winfrey', 'Affiliation': 'NOELA Community Health Center, New Orleans, LA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Department of Medicine, Tulane University School of Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Krousel-Wood', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Department of Medicine, Tulane University School of Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Department of Medicine, Tulane University School of Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA. Electronic address: jhe@tulane.edu.'}]",American heart journal,['10.1016/j.ahj.2020.08.009']
1413,32827501,Intranasal vasopressin expedites dishonesty in women.,"As an integral ingredient of human sociality, dishonesty can be both egocentric and altruistic, as well as gradually escalate. Here, we examined the influence of arginine vasopressin (AVP), a neuropeptide associated with human prosocial behaviors, on dishonest behaviors in men and women. In this double-blind and placebo-controlled study, 101 participants were randomized to administration of either 20 IU intranasal AVP or placebo. We used a two-party task to manipulate the incentive structure of dishonesty in the way of self-/other-serving repeatedly. For lies that benefit both themselves and others, women receiving intranasal AVP lied more than women receiving intranasal placebo and men receiving intranasal AVP. The dishonest behavior of women treated with AVP gradually escalated with repetition over time. These results suggest that AVP selectively regulates the escalation of dishonesty in women, contingent on the motivation of dishonesty. Our findings provide insight into gender-specific modulations of AVP on human dishonest behavior.",2020,"For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP.","['females', '101 participants', 'males and females']","['Intranasal vasopressin', 'intranasal AVP', 'AVP', 'intranasal placebo', '20\u202fIU intranasal AVP or placebo', 'arginine vasopressin (AVP', 'placebo']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],101.0,0.145508,"For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP.","[{'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, School of Psychology, Center for Studies of Psychological Application, Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, China. Electronic address: chunliang.feng@m.scnu.edu.cn.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Yuejia', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': 'Beijing Key Laboratory of Applied Experimental Psychology, Faculty of Psychology, Beijing Normal University, Beijing, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China; Great Bay Neuroscience and Technology Research Institute (Hong Kong), Kwun Tong, Hong Kong, China. Electronic address: xupf@szu.edu.cn.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104843']
1414,32827517,"Ropinirole, a dopamine agonist with high D 3  affinity, reduces proactive inhibition: A double-blind, placebo-controlled study in healthy adults.","Response inhibition describes the cognitive processes mediating the suppression of unwanted actions. A network involving the basal ganglia mediates two forms of response inhibition: reactive and proactive inhibition. Reactive inhibition serves to abruptly stop motor activity, whereas proactive inhibition is goal-orientated and results in slowing of motor activity in anticipation of stopping. Due to its impairment in several psychiatric disorders, the neurochemistry of response inhibition has become of recent interest. Dopamine has been posed as a candidate mediator of response inhibition due to its role in functioning of the basal ganglia and the observation that patients with Parkinson's disease on dopamine agonists develop impulse control disorders. Although the effects of dopamine on reactive inhibition have been studied, substantial literature on the role of dopamine on proactive inhibition is lacking. To fill this gap, we devised a double-blind, placebo-controlled study of 1 mg ropinirole (a dopamine agonist) on response inhibition in healthy volunteers. We found that whilst reactive inhibition was unchanged, proactive inhibition was impaired when participants were on ropinirole relative to when on placebo. To investigate how ropinirole mediated this effect on proactive inhibition, we used hierarchical drift-diffusion modelling. We found that ropinirole impaired the ability to raise the decision threshold when proactive inhibition was called upon. Our results provide novel evidence that an acute dose of ropinirole selectively reduces proactive inhibition in healthy participants. These results may help explain how ropinirole induces impulse control disorders in susceptible patients with Parkinson's disease.",2020,"We found that whilst reactive inhibition was unchanged, proactive inhibition was impaired when participants were on ropinirole relative to when on placebo.","[""susceptible patients with Parkinson's disease"", 'healthy volunteers', ""patients with Parkinson's disease on dopamine agonists develop impulse control disorders"", 'healthy adults', 'healthy participants']","['Dopamine', 'Ropinirole', 'ropinirole', 'ropinirole (a dopamine agonist', 'dopamine', 'placebo']","['reactive inhibition', 'proactive inhibition']","[{'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0021122', 'cui_str': 'Impulse control disorder'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0244821', 'cui_str': 'ropinirole'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034750', 'cui_str': 'Inhibition, Reactive'}, {'cui': 'C0033199', 'cui_str': 'Inhibition, Proactive'}]",,0.116831,"We found that whilst reactive inhibition was unchanged, proactive inhibition was impaired when participants were on ropinirole relative to when on placebo.","[{'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Rawji', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK. Electronic address: vishal.rawji.11@ucl.ac.uk.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Rocchi', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Foltynie', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Rothwell', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Jahanshahi', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}]",Neuropharmacology,['10.1016/j.neuropharm.2020.108278']
1415,32828825,Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial.,"BACKGROUND


In EMBRACA, talazoparib prolonged progression-free survival versus chemotherapy (hazard ratio [HR] 0.542 [95% confidence interval (CI) 0.413-0.711]; P < 0.0001) and improved patient-reported outcomes (PRO) in germline BRCA1/2 (gBRCA1/2)-mutated advanced breast cancer (ABC). We report final overall survival (OS).
PATIENTS AND METHODS


This randomized phase III trial enrolled patients with gBRCA1/2-mutated HER2-negative ABC. Patients received talazoparib or physician's choice of chemotherapy. OS was analyzed using stratified HR and log-rank test and prespecified rank-preserving structural failure time model to account for subsequent treatments.
RESULTS


A total of 431 patients were entered in a randomized study (287 talazoparib/144 chemotherapy) with 412 patients treated (286 talazoparib/126 chemotherapy). By 30 September 2019, 216 deaths (75.3%) occurred for talazoparib and 108 (75.0%) chemotherapy; median follow-up was 44.9 and 36.8 months, respectively. HR for OS with talazoparib versus chemotherapy was 0.848 (95% CI 0.670-1.073; P = 0.17); median (95% CI) 19.3 months (16.6-22.5 months) versus 19.5 months (17.4-22.4 months). Kaplan-Meier survival percentages (95% CI) for talazoparib versus chemotherapy: month 12, 71% (66% to 76%)/74% (66% to 81%); month 24, 42% (36% to 47%)/38% (30% to 47%); month 36, 27% (22% to 33%)/21% (14% to 29%). Most patients received subsequent treatments: for talazoparib and chemotherapy, 46.3%/41.7% received platinum and 4.5%/32.6% received a poly(ADP-ribose) polymerase (PARP) inhibitor, respectively. Adjusting for subsequent PARP and/or platinum use, HR for OS was 0.756 (95% bootstrap CI 0.503-1.029). Grade 3-4 adverse events occurred in 69.6% (talazoparib) and 64.3% (chemotherapy) patients, consistent with previous reports. Extended follow-up showed significant overall improvement and delay in time to definitive clinically meaningful deterioration in global health status/quality of life and breast symptoms favoring talazoparib versus chemotherapy (P < 0.01 for all), consistent with initial analyses.
CONCLUSIONS


In gBRCA1/2-mutated HER2-negative ABC, talazoparib did not significantly improve OS over chemotherapy; subsequent treatments may have impacted analysis. Safety was consistent with previous observations. PRO continued to favor talazoparib.",2020,"Extended follow-up showed significant overall improvement and delay in time to definitive clinically meaningful deterioration in global health status/quality of life and breast symptoms favoring talazoparib versus chemotherapy (P < 0.01 for all), consistent with initial analyses.
","['This randomized phase III trial enrolled patients with gBRCA1/2-mutated HER2-negative ABC', 'patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer', '431 patients were randomized (287 talazoparib/144 chemotherapy) with 412 patients treated (286 talazoparib/126 chemotherapy']","['poly(ADP-ribose) polymerase (PARP) inhibitor', 'talazoparib versus chemotherapy', 'Talazoparib versus chemotherapy', ""talazoparib or physician's choice of chemotherapy"", 'talazoparib and chemotherapy']","['Kaplan-Meier survival percentages', 'overall survival (OS', 'Grade 3-4 adverse events', 'global health status/quality of life and breast symptoms']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4042960', 'cui_str': 'talazoparib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",431.0,0.135085,"Extended follow-up showed significant overall improvement and delay in time to definitive clinically meaningful deterioration in global health status/quality of life and breast symptoms favoring talazoparib versus chemotherapy (P < 0.01 for all), consistent with initial analyses.
","[{'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Litton', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: jlitton@mdanderson.org.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Hurvitz', 'Affiliation': 'University of California, Los Angeles/Jonsson Comprehensive Cancer Center, Los Angeles, USA.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Mina', 'Affiliation': 'Banner M.D. Anderson Cancer Center, Gilbert, USA.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, USA.'}, {'ForeName': 'K-H', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Institut Paoli-Calmettes, Marseille, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Diab', 'Affiliation': 'Rocky Mountain Cancer Centers, Littleton, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Woodward', 'Affiliation': 'Mater Misericordiae Ltd/Mater Research Institute and the University of Queensland, Brisbane, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goodwin', 'Affiliation': 'Medical Oncology Department, Concord Repatriation General Hospital, Concord, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Yerushalmi', 'Affiliation': 'Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Roché', 'Affiliation': 'Institut Claudius Regaud, Institut Universitaire du Cancer de Toulouse, Toulouse, France.'}, {'ForeName': 'Y-H', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Eiermann', 'Affiliation': 'Interdisziplinäres Onkologisches Zentrum München, Munich, Germany.'}, {'ForeName': 'R G W', 'Initials': 'RGW', 'LastName': 'Quek', 'Affiliation': 'Pfizer Inc., San Francisco, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Usari', 'Affiliation': 'Pfizer Oncology, Milan, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lanzalone', 'Affiliation': 'Pfizer Oncology, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Czibere', 'Affiliation': 'Pfizer Inc., Cambridge, USA.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Blum', 'Affiliation': 'Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Instituto de Investigación Sanitaria Gregorio Marañón, CIBERONC, Departamento de Medicina, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ettl', 'Affiliation': 'Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.08.2098']
1416,32830552,Elevated plasma lactate levels via exogenous lactate infusion do not alter resistance exercise-induced signaling or protein synthesis in human skeletal muscle.,"Lactate has been implicated as a potential signaling molecule. In myotubes, lactate incubation increases mechanistic target of rapamycin complex 1 (mTORC1)- and ERK-signaling and induces hypertrophy, indicating that lactate could be a mediator of muscle adaptations to resistance exercise. However, the potential signaling properties of lactate, at rest or with exercise, have not been explored in human tissue. In a crossover design study, 8 men and 8 women performed one-legged resistance exercise while receiving venous infusion of saline or sodium lactate. Blood was sampled repeatedly, and muscle biopsies were collected at rest and at 0, 90, and 180 min and 24 h after exercise. The primary outcomes examined were intracellular signaling, fractional protein synthesis rate (FSR), and blood/muscle levels of lactate and pH. Postexercise blood lactate concentrations were 130% higher in the Lactate trial (3.0 vs. 7.0 mmol/L,  P  < 0.001), whereas muscle levels were only marginally higher (27 vs. 32 mmol/kg dry wt,  P  = 0.003) compared with the Saline trial. Postexercise blood pH was higher in the Lactate trial (7.34 vs. 7.44,  P  < 0.001), with no differences in intramuscular pH. Exercise increased the phosphorylation of mTOR S2448  (∼40%), S6K1 T389  (∼3-fold), and p44 T202/T204  (∼80%) during recovery, without any differences between trials. FSR over the 24-h recovery period did not differ between the Saline (0.067%/h) and Lactate (0.062%/h) trials. This study does not support the hypothesis that blood lactate levels can modulate anabolic signaling in contracted human muscle. Further in vivo research investigating the impact of exercised versus rested muscle and the role of intramuscular lactate is needed to elucidate its potential signaling properties.",2020,"Post-exercise blood pH was higher in the Lactate-trial (7.34 vs 7.44, p<0.001), with no differences in intramuscular pH. Exercise increased the phosphorylation of mTOR S2448  (~40%), S6K1 T389  (~3-fold), and p44 T202/T204  (~80%) during recovery, without any differences between trials.",['8 men and 8 women performed one'],['legged resistance exercise while receiving venous infusion of saline or sodium lactate'],"['Post-exercise blood pH', 'FSR', 'intracellular signaling, fractional protein synthesis rate (FSR), and blood/muscle levels of lactate and pH. Post-exercise blood lactate concentrations', 'muscle levels', 'phosphorylation of mTOR S2448']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0142874', 'cui_str': 'Sodium lactate'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0853363', 'cui_str': 'Blood pH'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0597295', 'cui_str': 'Genetic translation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}]",8.0,0.0586339,"Post-exercise blood pH was higher in the Lactate-trial (7.34 vs 7.44, p<0.001), with no differences in intramuscular pH. Exercise increased the phosphorylation of mTOR S2448  (~40%), S6K1 T389  (~3-fold), and p44 T202/T204  (~80%) during recovery, without any differences between trials.","[{'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Liegnell', 'Affiliation': 'Department of Physiology, Nutrition and Biomechaniscs, Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Apró', 'Affiliation': 'Department of Physiology, Nutrition and Biomechaniscs, Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Danielsson', 'Affiliation': 'Department of Physiology, Nutrition and Biomechaniscs, Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Ekblom', 'Affiliation': 'Department of Physiology, Nutrition and Biomechaniscs, Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'van Hall', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Hans-Christer', 'Initials': 'HC', 'LastName': 'Holmberg', 'Affiliation': 'Swedish Winter Sports Research Centre, Department of Health Sciences, Mid Sweden University, Östersund, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Moberg', 'Affiliation': 'Department of Physiology, Nutrition and Biomechaniscs, Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00291.2020']
1417,32830617,"The Efficiency, Efficacy, and Retention of Task Practice in Chronic Stroke.","In motor skill learning, larger doses of practice lead to greater efficacy of practice, lower efficiency of practice, and better long-term retention. Whether such learning principles apply to motor practice after stroke is unclear. Here, we developed novel mixed-effects models of the change in the perceived quality of arm movements during and following task practice. The models were fitted to data from a recent randomized controlled trial of the effect of dose of task practice in chronic stroke. Analysis of the models' learning and retention rates demonstrated an increase in efficacy of practice with greater doses, a decrease in efficiency of practice with both additional dosages and additional bouts of training, and fast initial decay following practice. Two additional effects modulated retention: a positive ""self-practice"" effect, and a negative effect of dose. Our results further suggest that for patients with sufficient arm use post-practice, self-practice will further improve use.",2020,"Analysis of the models' learning and retention rates demonstrated an increase in efficacy of practice with greater doses, a decrease in efficiency of practice with both additional dosages and additional bouts of training, and fast initial decay following practice.",['chronic stroke'],[],"['Efficiency, Efficacy, and Retention of Task Practice in Chronic Stroke']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]",[],"[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]",,0.0577901,"Analysis of the models' learning and retention rates demonstrated an increase in efficacy of practice with greater doses, a decrease in efficiency of practice with both additional dosages and additional bouts of training, and fast initial decay following practice.","[{'ForeName': 'Chunji', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Neuroscience Graduate Program, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Carolee', 'Initials': 'C', 'LastName': 'Winstein', 'Affiliation': 'Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'David Z', 'Initials': 'DZ', 'LastName': ""D'Argenio"", 'Affiliation': 'Biomedical Engineering, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Schweighofer', 'Affiliation': 'Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320948609']
1418,32840572,Metabolic Availability of Lysine in Milk and a Vegetarian Cereal-Legume Meal Determined by the Indicator Amino Acid Oxidation Method in Indian Men.,"BACKGROUND


Lysine rich foods such as milk and legumes serve as important food additions to the lysine deficient cereal-based diets of vegetarian populations in low- and middle-income countries (LMICs) to alleviate the risk of quality corrected dietary protein inadequacy. Dietary protein quality can be determined by estimating the metabolic availability (MA) of lysine.
OBJECTIVES


The study aimed to estimate the MA of lysine in spray-dried cow milk powder (SMP), heat-treated spray-dried cow milk powder (HSMP), and a habitually consumed cereal-legume based vegetarian meal (VM), using the indicator amino acid oxidation (IAAO) slope-ratio method.
METHODS


The MA of lysine in SMP, HSMP, and VM was estimated in 7 healthy young men aged 19-24 y with BMI of 21.5 ± 0.5 kg/m2 in a repeated measures design. The IAAO response slopes with 2 graded lysine intakes (10.5 and 15.0 mg·kg-1·d-1) from the SMP and VM were compared with the response slope generated with 3 graded crystalline lysine intakes (6.0, 10.5, and 15.0 mg·kg-1·d-1) at the subrequirement level. To produce HSMP, pasteurized cow milk was heat treated and spray dried. The MA of lysine in HSMP was tested at a single level of lysine intake (15 mg·kg-1·d-1). A total of 8 IAAO experiments were conducted on each participant in randomized order. The IAAO slopes were estimated using a linear mixed-effect regression model.
RESULTS


The MA of lysine in SMP, HSMP, and VM was 91.9%, 69.9%, and 86.6% respectively.
CONCLUSIONS


Heat treatment reduced the MA of lysine by 22% in HSMP compared with SMP in healthy Indian adults. The lysine MA estimates can be used to optimize lysine limited cereal-based diets, with the addition of appropriately processed legumes and milk powder, to meet the protein requirement. This trial was registered at Clinical Trials Registry of India (http://ctri.nic.in) as CTRI/2019/08/020568.",2020,"The IAAO response slopes with 2 graded lysine intakes (10.5 and 15.0 mg·kg-1·d-1) from the SMP and VM were compared with the response slope generated with 3 graded crystalline lysine intakes (6.0, 10.5, and 15.0 mg·kg-1·d-1) at the subrequirement level.","['7 healthy young men aged 19-24 y with BMI of 21.5\xa0±\xa00.5\xa0kg/m2 in a repeated measures design', 'healthy Indian adults', 'Indian Men']","['SMP', 'HSMP', 'MA of lysine in spray-dried cow milk powder (SMP), heat-treated spray-dried cow milk powder (HSMP), and a habitually consumed cereal-legume based vegetarian meal (VM', 'Lysine in Milk and a Vegetarian Cereal-Legume Meal']","['MA of lysine in SMP, HSMP, and VM', 'indicator amino acid oxidation (IAAO) slope-ratio method', 'MA of lysine', 'IAAO slopes', 'IAAO response slopes']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0452726', 'cui_str': ""Dried cow's milk""}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0023263', 'cui_str': 'Pea family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042441', 'cui_str': 'Vegetarian'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0452726', 'cui_str': ""Dried cow's milk""}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0042441', 'cui_str': 'Vegetarian'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",7.0,0.0252093,"The IAAO response slopes with 2 graded lysine intakes (10.5 and 15.0 mg·kg-1·d-1) from the SMP and VM were compared with the response slope generated with 3 graded crystalline lysine intakes (6.0, 10.5, and 15.0 mg·kg-1·d-1) at the subrequirement level.","[{'ForeName': 'Sulagna', 'Initials': 'S', 'LastName': 'Bandyopadhyay', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, Research Center of University of Mysore, St. John's National Academy of Health Sciences, Bengaluru, India.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kuriyan', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, Research Center of University of Mysore, St. John's National Academy of Health Sciences, Bengaluru, India.""}, {'ForeName': 'Nirupama', 'Initials': 'N', 'LastName': 'Shivakumar', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, Research Center of University of Mysore, St. John's National Academy of Health Sciences, Bengaluru, India.""}, {'ForeName': 'Santu', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': ""Department of Biostatistics, St. John's Medical College, St. John's National Academy of Health Sciences, Bengaluru, India.""}, {'ForeName': 'Rajendran', 'Initials': 'R', 'LastName': 'Ananthan', 'Affiliation': 'Food Chemistry Division, ICMR-National Institute of Nutrition, Jamai-Osmania, Hyderabad, India.'}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Devi', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, Research Center of University of Mysore, St. John's National Academy of Health Sciences, Bengaluru, India.""}, {'ForeName': 'Anura V', 'Initials': 'AV', 'LastName': 'Kurpad', 'Affiliation': ""Department of Physiology, St. John's Medical College, St. John's National Academy of Health Sciences, Bengaluru, India.""}]",The Journal of nutrition,['10.1093/jn/nxaa235']
1419,32840580,"Bioavailable Lysine, Assessed in Healthy Young Men Using Indicator Amino Acid Oxidation, is Greater when Cooked Millet and Stewed Canadian Lentils are Combined.","BACKGROUND


Pearl millet is the chief source of energy in the diet in some developing regions, but has a limited amount of indispensable amino acid lysine. Complementation with pulses like lentils can improve the protein quality of millet diets, but the knowledge of lysine bioavailability (BA) in millet and lentils is lacking.
OBJECTIVES


The study objectives were to determine the BA of lysine in millet and lentils separately and to assess the effect of complementation of millet and lentils in a mixed meal format.
METHODS


We studied 9 healthy young men (≤30 y; BMI <25) in a repeated-measure design using the indicator amino acid oxidation (IAAO) method, with L-[1-13C] phenylalanine as the indicator. Each subject completed 7 or 8 experiments in random order. On the reference diet, subjects received 4 graded levels of L-lysine (5, 8, 12, and 15 mg·kg-1.d-1) from a crystalline amino acid mixture patterned after egg protein; on the test diets, they received 3 levels of lysine (10, 12, and 15 mg·kg-1.d-1) from either steamed millet or stewed lentils; and on the complementation diet, they received 1 level of lysine from a mixed meal of steamed millet and stewed lentils. The BA of lysine and the effect of complementation were assessed by comparing the IAAO responses to the test diets and the complementation diet with the IAAO response to L-lysine intakes in the reference protein, using the slope ratio method.
RESULTS


The BA of lysine was 97% from millet and 80% from lentils. Complementation of steamed millet with stewed lentils decreased the oxidation of L-[1-13C] phenylalanine by 27% (P < 0.05), signifying improved quality of the combined millet and lentil protein.
CONCLUSIONS


Lysine has high BA but is still limiting in steamed pearl millet. Complementation with lentils in a 2:1 ratio is recommended to meet the lysine and protein requirements for adult men consuming a millet-based diet. This trial was registered at clinicaltrials.gov as NCT03674736 and NCT03339167.",2020,"Complementation of steamed millet with stewed lentils decreased the oxidation of L-[1-13C] phenylalanine by 27% (P < 0.05), signifying improved quality of the combined millet and lentil protein.
","['adult men consuming a millet-based diet', 'Healthy Young Men', '9 healthy young men (≤30 y; BMI\xa0<25']","['4 graded levels of L-lysine (5, 8, 12, and 15 mg·kg-1.d-1) from a crystalline amino acid mixture patterned after egg protein; on the test diets, they received 3 levels of lysine (10, 12, and 15 mg·kg-1.d-1) from either steamed millet or stewed lentils; and on the complementation diet, they received 1 level of lysine from a mixed meal of steamed millet and stewed lentils', 'indicator amino acid oxidation (IAAO) method, with L-[1-13C] phenylalanine', 'Bioavailable Lysine']","['oxidation of L-[1-13C] phenylalanine', 'BA of lysine', 'IAAO responses']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0937879', 'cui_str': 'Millet extract'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0444626', 'cui_str': 'Crystal'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0013700', 'cui_str': 'Egg protein'}, {'cui': 'C0452401', 'cui_str': 'Test diet'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0937879', 'cui_str': 'Millet extract'}, {'cui': 'C0023323', 'cui_str': 'Lentils'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0038225', 'cui_str': 'Steam'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}]","[{'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}]",9.0,0.0312511,"Complementation of steamed millet with stewed lentils decreased the oxidation of L-[1-13C] phenylalanine by 27% (P < 0.05), signifying improved quality of the combined millet and lentil protein.
","[{'ForeName': 'Abrar', 'Initials': 'A', 'LastName': 'Fakiha', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Zujaja', 'Initials': 'Z', 'LastName': 'Tul-Noor', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Paoletti', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Pencharz', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Ronald O', 'Initials': 'RO', 'LastName': 'Ball', 'Affiliation': 'Departments of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Crystal L', 'Initials': 'CL', 'LastName': 'Levesque', 'Affiliation': 'Department of Animal Science, South Dakota State University, Brookings, SD, USA.'}, {'ForeName': 'Rajavel', 'Initials': 'R', 'LastName': 'Elango', 'Affiliation': 'Department of Pediatrics, School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Courtney-Martin', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxaa227']
1420,32853691,Development and validation of screening scores of non-alcoholic fatty liver disease in middle-aged and elderly Chinese.,"AIM


Non-alcoholic fatty liver disease (NAFLD) is one of the most common causes of chronic liver disease and also closely related to cardiometabolic disease. Its prevalence was estimated at over one-fourth in the general population in China. We aimed to develop effective score tools for detecting NAFLD.
METHODS


A total of 17,212 participants aged 45-70 years old were surveyed in Shanghai between 2013 and 2014, and 13,293 participants were included in this analysis. All participants were randomly classified into the exploratory group or the validation group. Candidate categorical variables were selected using a logistic regression model. The score points were generated according to the β-coefficients.
RESULTS


We developed the Shanghai Nicheng NAFLD Score I (SHNC NAFLD Score I), which included body mass index and waist circumference with an area under the receiver-operating characteristic curve (AUC) of 0.802 (95% CI 0.792-0.811) in the exploratory group and 0.802 (95% CI 0.793-0.812) in the validation group. We further developed the SHNC NAFLD Score II by adding fasting plasma glucose, triglyceride, and alanine aminotransferase/aspartate aminotransferase ratio to the SHNC NAFLD Score I, achieving an AUC of 0.852 (95% CI 0.843-0.861) in the exploratory group and 0.843 (95% CI 0.834-0.852) in the validation group. The two score tools also performed well in subjects with normal alanine aminotransferase (ALT) levels.
CONCLUSIONS


Based on anthropometric and clinical categorical variables, our two scores are effective tools for detecting NAFLD in both this southern Chinese population and their subpopulation with normal ALT levels.",2020,"The two score tools also performed well in subjects with normal alanine aminotransferase (ALT) levels.
","['subjects with normal alanine aminotransferase (ALT) levels', 'middle-aged and elderly Chinese', '17,212 participants aged 45-70 years old were surveyed in Shanghai between 2013 and 2014, and 13,293 participants were included in this analysis']",[],"['Shanghai Nicheng NAFLD Score I (SHNC NAFLD Score I', 'SHNC NAFLD Score II by adding fasting plasma glucose, triglyceride, and alanine aminotransferase/aspartate aminotransferase ratio to the SHNC NAFLD Score I, achieving an AUC']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",17212.0,0.0822862,"The two score tools also performed well in subjects with normal alanine aminotransferase (ALT) levels.
","[{'ForeName': 'Yebei', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Ye', 'Affiliation': ""Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Xuhong', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China. Electronic address: houxuhong@sjtu.edu.cn.""}, {'ForeName': 'Peizhu', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Fusong', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': ""Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Lichang', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': ""Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Huaiyu', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Prevention and Health Care, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Yuqian', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Jia', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China. Electronic address: wpjia@sjtu.edu.cn.""}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108385']
1421,32825324,High-Dose Vitamin D Supplementation Improves Microcirculation and Reduces Inflammation in Diabetic Neuropathy Patients.,"We assessed the effect of different doses of vitamin D supplementation on microcirculation, signs and symptoms of peripheral neuropathy and inflammatory markers in patients with type 2 diabetes (T2DM). Sixty-seven patients with T2DM and peripheral neuropathy (34 females) were randomized into two treatment groups: Cholecalciferol 5000 IU and 40,000 IU once/week orally for 24 weeks. Severity of neuropathy (NSS, NDS scores, visual analogue scale), cutaneous microcirculation (MC) parameters and inflammatory markers (ILs, CRP, TNFα) were assessed before and after treatment. Vitamin D deficiency/insufficiency was detected in 78% of the 62 completed subjects. Following treatment with cholecalciferol 40,000 IU/week, a significant decrease in neuropathy severity (NSS,  p  = 0.001; NDS,  p  = 0.001; VAS,  p  = 0.001) and improvement of cutaneous MC were observed ( p  < 0.05). Also, we found a decrease in IL-6 level (2.5 pg/mL vs. 0.6 pg/mL,  p  < 0.001) and an increase in IL-10 level (2.5 pg/mL vs. 4.5 pg/mL,  p  < 0.001) after 24 weeks of vitamin D supplementation in this group. No changes were detected in the cholecalciferol 5000 IU/week group. High-dose cholecalciferol supplementation of 40,000 IU/week for 24 weeks was associated with improvement in clinical manifestation, cutaneous microcirculation and inflammatory markers in patients with T2DM and peripheral neuropathy.",2020,"Severity of neuropathy (NSS, NDS scores, visual analogue scale), cutaneous microcirculation (MC) parameters and inflammatory markers (ILs, CRP, TNFα) were assessed before and after treatment.","['78% of the 62 completed subjects', 'Diabetic Neuropathy Patients', 'Sixty-seven patients with T2DM and peripheral neuropathy (34 females', 'patients with type 2 diabetes (T2DM', 'patients with T2DM and peripheral neuropathy']","['High-Dose Vitamin D Supplementation', 'Cholecalciferol 5000 IU', 'vitamin D supplementation', 'cholecalciferol']","['microcirculation, signs and symptoms of peripheral neuropathy and inflammatory markers', 'Vitamin D deficiency/insufficiency', 'clinical manifestation, cutaneous microcirculation and inflammatory markers', 'neuropathy severity', 'Severity of neuropathy (NSS, NDS scores, visual analogue scale), cutaneous microcirculation (MC) parameters and inflammatory markers (ILs, CRP, TNFα', 'improvement of cutaneous MC', 'IL-10 level', 'IL-6 level']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4319610', 'cui_str': '5000'}]","[{'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0194086', 'cui_str': 'Partial nephrectomy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",67.0,0.160226,"Severity of neuropathy (NSS, NDS scores, visual analogue scale), cutaneous microcirculation (MC) parameters and inflammatory markers (ILs, CRP, TNFα) were assessed before and after treatment.","[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Karonova', 'Affiliation': 'Almazov National Medical Research Centre, Institute of Endocrinology, 2 Akkuratova str., 197341 St. Petersburg, Russia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Stepanova', 'Affiliation': 'Internal Medicine Department, Pavlov First Saint Petersburg State Medical University, 6-8 L.Tolstoy str., 197022 St. Petersburg, Russia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bystrova', 'Affiliation': 'Almazov National Medical Research Centre, Institute of Endocrinology, 2 Akkuratova str., 197341 St. Petersburg, Russia.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Jude', 'Affiliation': 'Tameside Hospital NHS Foundation Trust, Ashton Under Lyne OL69RW, UK.'}]",Nutrients,['10.3390/nu12092518']
1422,32822775,Tocilizumab improves oxidative stress and endothelial glycocalyx: A mechanism that may explain the effects of biological treatment on COVID-19.,"We investigated the effects of tocilizumab on endothelial glycocalyx, a determinant of vascular permeability, and myocardial function in rheumatoid arthritis (RA). Eighty RA patients were randomized to tocilizumab (n = 40) or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and glucocorticoids (GC) (n = 40) for 3 months. Forty healthy subjects with similar age and sex served as controls. We measured: (a)perfused boundary region (PBR) of the sublingual arterial microvessels (increased PBR indicates reduced glycocalyx thickness), (b)pulse wave velocity (PWV), (c)global LV longitudinal strain (GLS), (d)global work index (GWI) using speckle tracking echocardiography and e)C-reactive protein (CRP), malondialdehyde (MDA) and protein carbonyls (PCs) as oxidative stress markers at baseline and post-treatment. Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers (P < 0.05). Compared with baseline, tocilizumab reduced PBR(2.14 ± 0.2 versus 1.97 ± 0.2 μm; P < 0.05) while no significant differences were observed post-csDMARDs + GC(P > 0.05). Compared with csDMARDs + GC, tocilizumab achieved a greater increase of GLS, GWI and reduction of MDA, PCs and CRP(P < 0.05). The percent improvement of glycocalyx thickness (PBR) was associated with the percent decrease of PWV, MDA, PCs and the percent improvement of GLS and GWI(P < 0.05). Tocilizumab improves endothelial function leading to a greater increase of effective myocardial work than csDMARDs + GC through a profound reduction of inflammatory burden and oxidative stress. This mechanism may explain the effects of tocilizumab on COVID-19. CLINICAL TRIAL REGISTRATION: url: https://www.clinicaltrials.gov. Unique identifier: NCT03288584.",2020,"Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers(P<0.05).","['Eighty RA patients', 'Forty healthy subjects with similar age and sex served as controls', 'rheumatoid arthritis(RA']","['csDMARDs+GC', 'tocilizumab', 'csDMARDs+GC, tocilizumab', 'Tocilizumab', 'tocilizumab(n=40) or conventional synthetic disease-modifying antirheumatic drugs(csDMARDs) and glucocorticoids(GC']","['glycocalyx thickness), b)pulse wave velocity(PWV), c)global LV longitudinal strain(GLS), d)global work index(GWI) using speckle tracking echocardiography and e)C-reactive protein(CRP), malondialdehyde(MDA) and protein carbonyls(PCs) as oxidative stress markers', 'PWV, MDA, PCs and the percent improvement of GLS and GWI(P<0.05', 'oxidative stress and endothelial glycocalyx', 'glycocalyx thickness(PBR', 'GLS, GWI and reduction of MDA, PCs and CRP(P<0.05']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017767', 'cui_str': 'Glucosinolate'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",80.0,0.0830911,"Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers(P<0.05).","[{'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece. Electronic address: ignoik@gmail.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Pavlidis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Pelagia', 'Initials': 'P', 'LastName': 'Katsimbri', 'Affiliation': '4th Department of Internal Medicine, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Vaia', 'Initials': 'V', 'LastName': 'Lambadiari', 'Affiliation': '2nd Department of Internal Medicine, Research Unit and Diabetes Center, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Parissis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Andreadou', 'Affiliation': 'Laboratory of Pharmacology, Faculty of Pharmacy, National and Kapodistrian University of Athens, 15741, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsoumani', 'Affiliation': 'Laboratory of Pharmacology, Faculty of Pharmacy, National and Kapodistrian University of Athens, 15741, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Boumpas', 'Affiliation': '4th Department of Internal Medicine, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kouretas', 'Affiliation': 'Department of Biochemistry and Biotechnology, University of Thessaly, 41500, Larissa, Greece.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Iliodromitis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111694']
1423,32824709,Short and Long-Term Trainability in Older Adults: Training and Detraining Following Two Years of Multicomponent Cognitive-Physical Exercise Training.,"Despite the benefits of multicomponent physical-cognitive training programs (MC Cog TPs), lower training intensities in the concurrent approach, and bigger heterogeneity with aging, suggest the need for long-term analyses, with special attention to training and detraining in older adults. The present study aims to examine these training/detraining effects in a two year MC Cog TP, looking for specific dynamics in the trainability of their physical and cognitive capacities. The intervention was divided into four periods: T1, T2 (8 months of training each), and D1, D2 (3.5 months of detraining plus 0.5 of testing each). Twenty-five healthy seniors (70.82 ± 5.18 years) comprised the final sample and were assessed for cardiovascular fitness (6-minutes walking test), lower-limbs strength (30-seconds chair-stand test) and agility (8-feet timed up-and-go test). Inhibition (Stroop test) was considered for executive function. Physical and cognitive status improved significantly ( p  < 0.05) throughout the two years, with larger enhancements for physical function (mainly strength and agility). Strength and cardiovascular fitness were more sensitive to detraining, whilst agility proved to have larger training retentions. Inhibition followed an initial similar trend, but it was the only variable to improve along D2 (d = 0.52), and changes were not significant within periods. Notwithstanding aging, and the exercise cessation in D2, physical and cognitive status remained enhanced two years later compared to baseline, except for lower-limb strength. According to these results, basic physical capacities are very sensitive to training/detraining, deserving continuous attention (especially strength). Both reducing detraining periods and complementary resistance training should be considered. Additionally, physical enhancements following MC cog TPs may help cognition maintenance during detraining.",2020,"Physical and cognitive status improved significantly ( p  < 0.05) throughout the two years, with larger enhancements for physical function (mainly strength and agility).","['Older Adults', 'older adults', 'Twenty-five healthy seniors (70.82 ± 5.18 years']","['Training and Detraining Following Two Years of Multicomponent Cognitive-Physical Exercise Training', 'multicomponent physical-cognitive training programs (MC Cog TPs']","['Physical and cognitive status', 'cardiovascular fitness (6-minutes walking test), lower-limbs strength (30-seconds chair-stand test) and agility', 'Strength and cardiovascular fitness', 'physical function (mainly strength and agility', 'cognition maintenance', 'exercise cessation in D2, physical and cognitive status']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0289863', 'cui_str': 'tissue polypeptide specific antigen'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",25.0,0.0109849,"Physical and cognitive status improved significantly ( p  < 0.05) throughout the two years, with larger enhancements for physical function (mainly strength and agility).","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Physical Education and Sports Department, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Cordellat', 'Affiliation': 'Physical Education and Sports Department, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Anabel', 'Initials': 'A', 'LastName': 'Forte', 'Affiliation': 'Statistics and Operational Research Department, University of Valencia, 46100 Burjassot, Valencia, Spain.'}, {'ForeName': 'Ainoa', 'Initials': 'A', 'LastName': 'Roldán', 'Affiliation': 'Physical Education and Sports Department, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Monteagudo', 'Affiliation': 'Sport Performance & Physical Fitness Research Group (UIRFIDE), University of Valencia, 46010 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17165984']
1424,32827598,Parental-oriented educational mobile messages to aid in the control of early childhood caries in low socioeconomic children: A randomized controlled trial.,"OBJECTIVES


To evaluate the effectiveness of educational messages as an aid in the control of early childhood caries (ECC) in low socioeconomic children.
METHODS


A single-blinded, randomized, and parallel-group study was conducted with 104 dyads of parents and children aged between 36-60 months, recruited in preschools from Bauru, Brazil. The participants were randomly allocated into control and intervention groups (1:1), stratified by parental eHealth literacy scores (eHEALS) and children's caries experience. Every 2 weeks, text messages were sent to parents of intervention group via WhatsApp. Visible plaque index (VPI) and the International Caries Detection and Assessment System (ICDAS) were assessed at baseline, 3- and 6-month follow-ups, while eHEALS and dietary habits were determined at baseline and 6-month follow-up. Statistical analysis was performed to intra and intergroup comparisons through Fischer's exact and McNemar tests, and Mann-Whitney U and Friedman tests, respectively (P < 0.05).
RESULTS


Despite similarities between groups, intervention increased parental eHEALS scores, influencing the reports about the children's consumption of sugar-free sweets and controlling the severity of ECC.
CONCLUSION


Therefore, mobile text messages were effective to control the severity of ECC in low socioeconomic preschoolers, improving parental eHealth literacy and changing children's dietary patterns.
CLINICAL SIGNIFICANCE


These findings demonstrate that parental-oriented WhatsApp messages can contribute to oral health education of socioeconomic vulnerable parents towards risk behavior changes to control ECC.",2020,These findings demonstrate that parental-oriented WhatsApp messages can contribute to oral health education of socioeconomic vulnerable parents towards risk behavior changes to control ECC.,"['low socioeconomic children', '104 dyads of parents and children aged between 36-60 months, recruited in preschools from (blinded']","['educational messages', 'parental-oriented mobile text messages', 'Parental-oriented educational mobile messages']","['Visible plaque index (VPI) and the International Caries Detection and Assessment System (ICDAS', 'parental eHEALS scores']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0747732,These findings demonstrate that parental-oriented WhatsApp messages can contribute to oral health education of socioeconomic vulnerable parents towards risk behavior changes to control ECC.,"[{'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Lotto', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Anna Paola', 'Initials': 'AP', 'LastName': 'Strieder', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Patricia Estefania', 'Initials': 'PE', 'LastName': 'Ayala Aguirre', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Thais Marchini', 'Initials': 'TM', 'LastName': 'Oliveira', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Maria Aparecida', 'Initials': 'MA', 'LastName': 'Andrade Moreira Machado', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rios', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Cruvinel', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil. Electronic address: thiagocruvinel@fob.usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103456']
1425,32828135,Hydroxychloroquine in the Treatment of COVID-19: A Multicenter Randomized Controlled Study.,"The COVID-19 pandemic is showing an exponential growth, mandating an urgent need to develop an effective treatment. Indeed, to date, a well-established therapy is still lacking. We aimed to evaluate the safety and efficacy of hydroxychloroquine (HCQ) added to standard care in patients with COVID-19. This was a multicenter, randomized controlled trial conducted at three major university hospitals in Egypt. One hundred ninety-four patients with confirmed diagnosis of COVID-19 were included in the study after signing informed consent. They were equally randomized into two arms: 97 patients administrated HCQ plus standard care (HCQ group) and 97 patients administered only standard care as a control arm (control group). The primary endpoints were recovery within 28 days, need for mechanical ventilation, or death. The two groups were matched for age and gender. There was no significant difference between them regarding any of the baseline characteristics or laboratory parameters. Four patients (4.1%) in the HCQ group and 5 (5.2%) patients in the control group needed mechanical ventilation ( P  = 0.75). The overall mortality did not differ between the two groups, as six patients (6.2%) died in the HCQ group and 5 (5.2%) died in the control group ( P  = 0.77). Univariate logistic regression analysis showed that HCQ treatment was not significantly associated with decreased mortality in COVID-19 patients. So, adding HCQ to standard care did not add significant benefit, did not decrease the need for ventilation, and did not reduce mortality rates in COVID-19 patients.",2020,"The overall mortality did not differ between the two groups, as six patients (6.2%) died in the HCQ group and 5 (5.2%) died in the control group ( P  = 0.77).","['patients with COVID-19', 'COVID-19', 'three major university hospitals in Egypt', 'One hundred ninety-four patients with confirmed diagnosis of COVID-19 were included in the study after signing informed consent']","['HCQ plus standard care (HCQ group) and 97 patients administered only standard care as a control arm (control group', 'Hydroxychloroquine', 'hydroxychloroquine (HCQ', 'HCQ']","['mechanical ventilation', 'mortality rates', 'safety and efficacy', 'recovery within 28 days, need for mechanical ventilation, or death', 'overall mortality', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",194.0,0.126559,"The overall mortality did not differ between the two groups, as six patients (6.2%) died in the HCQ group and 5 (5.2%) died in the control group ( P  = 0.77).","[{'ForeName': 'Sherief', 'Initials': 'S', 'LastName': 'Abd-Elsalam', 'Affiliation': 'Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Eslam Saber', 'Initials': 'ES', 'LastName': 'Esmail', 'Affiliation': 'Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Khalaf', 'Affiliation': 'Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ehab Fawzy', 'Initials': 'EF', 'LastName': 'Abdo', 'Affiliation': 'Department of Gastroenterology and Tropical Medicine, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Medhat', 'Affiliation': 'Department of Gastroenterology and Tropical Medicine, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed Samir', 'Initials': 'MS', 'LastName': 'Abd El Ghafar', 'Affiliation': 'Department of Anesthesia, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ossama Ashraf', 'Initials': 'OA', 'LastName': 'Ahmed', 'Affiliation': 'Department of Internal Medicine, Ain-Shams University, Cairo, Egypt.'}, {'ForeName': 'Shaimaa', 'Initials': 'S', 'LastName': 'Soliman', 'Affiliation': 'Public Health and Community Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Ghada N', 'Initials': 'GN', 'LastName': 'Serangawy', 'Affiliation': 'Department of Forensic Medicine and Toxicology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Alboraie', 'Affiliation': 'Department of Internal Medicine, Al-Azhar University, Cairo, Egypt.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0873']
1426,32840201,"Impact of Low-Cost Point-of-Use Water Treatment Technologies on Enteric Infections and Growth among Children in Limpopo, South Africa.","Enteric infections early in life have been associated with poor linear growth among children in low-resource settings. Point-of-use water treatment technologies provide effective and low-cost solutions to reduce exposure to enteropathogens from drinking water, but it is unknown whether the use of these technologies translates to improvements in child growth. We conducted a community-based randomized controlled trial of two water treatment technologies to estimate their effects on child growth in Limpopo, South Africa. We randomized 404 households with a child younger than 3 years to receive a silver-impregnated ceramic water filter, a silver-impregnated ceramic tablet, a safe-storage water container alone, or no intervention, and these households were followed up quarterly for 2 years. We estimated the effects of the interventions on linear and ponderal growth, enteric infections assessed by quantitative molecular diagnostics, and diarrhea prevalence. The silver-impregnated ceramic water filters and tablets consistently achieved approximately 1.2 and 3 log reductions, respectively, in total coliform bacteria in drinking water samples. However, the filters and tablets were not associated with differences in height (height-for-age  z -score differences compared with no intervention: 0.06, 95% CI: -0.29, 0.40, and 0.00, 95% CI: -0.35, 0.35, respectively). There were also no effects of the interventions on weight, diarrhea prevalence, or enteric infections. Despite their effectiveness in treating drinking water, the use of the silver-impregnated ceramic water filters and tablets did not reduce enteric infections or improve child growth. More transformative water, sanitation, and hygiene interventions that better prevent enteric infections are likely needed to improve long-term child growth outcomes.",2020,"The silver-impregnated ceramic water filters and tablets consistently achieved approximately 1.2 and 3 log reductions, respectively, in total coliform bacteria in drinking water samples.","['Children in Limpopo, South Africa', '404 households with a child younger than 3 years to receive a', 'child growth in Limpopo, South Africa']","['silver-impregnated ceramic water filter, a silver-impregnated ceramic tablet, a safe-storage water container alone, or no intervention', 'Low-Cost Point-of-Use Water Treatment Technologies']","['enteric infections', 'weight, diarrhea prevalence, or enteric infections', 'linear and ponderal growth, enteric infections assessed by quantitative molecular diagnostics, and diarrhea prevalence', 'total coliform bacteria']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]","[{'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0180098', 'cui_str': 'Container'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0597684', 'cui_str': 'Water Treatment'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C2121080', 'cui_str': 'Molecular Diagnostics'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0314760', 'cui_str': 'Coliform bacteria'}]",404.0,0.0517983,"The silver-impregnated ceramic water filters and tablets consistently achieved approximately 1.2 and 3 log reductions, respectively, in total coliform bacteria in drinking water samples.","[{'ForeName': 'Courtney L', 'Initials': 'CL', 'LastName': 'Hill', 'Affiliation': 'Department of Engineering Systems and Environment, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'McCain', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Mzwakhe E', 'Initials': 'ME', 'LastName': 'Nyathi', 'Affiliation': 'Department of Animal Science, University of Venda, Thohoyandou, South Africa.'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Edokpayi', 'Affiliation': 'Department of Hydrology and Water Resources Mining and Environmental Geology, University of Venda, Thohoyandou, South Africa.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kahler', 'Affiliation': 'Center for Environmental Research and Education, Duquesne University, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Darwin J', 'Initials': 'DJ', 'LastName': 'Operario', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'David D J', 'Initials': 'DDJ', 'LastName': 'Taylor', 'Affiliation': 'Department of Civil and Mineral Engineering, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Natasha C', 'Initials': 'NC', 'LastName': 'Wright', 'Affiliation': 'Department of Mechanical Engineering, University of Minnesota Twin Cities, Minneapolis, Minnesota.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'Department of Engineering Systems and Environment, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Guerrant', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Amidou', 'Initials': 'A', 'LastName': 'Samie', 'Affiliation': 'Department of Microbiology, University of Venda, Thohoyandou, South Africa.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Dillingham', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Pascal O', 'Initials': 'PO', 'LastName': 'Bessong', 'Affiliation': 'Department of Microbiology, University of Venda, Thohoyandou, South Africa.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Rogawski McQuade', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, Virginia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0228']
1427,32833762,Long-term Oncologic Results After Stenting as a Bridge to Surgery Versus Emergency Surgery for Malignant Left-sided Colonic Obstruction: A Multicenter Randomized Controlled Trial (ESCO Trial).,"OBJECTIVE


To assess overall (OS), time to progression (TTP), and disease-free survival (DFS) at 3 years after treatment, comparing stenting as bridge-to-surgery (SBTS) versus emergency surgery (ES) in neoplastic left colon obstruction, secondary endpoints of the previously published randomized controlled trial.
BACKGROUND


While SBTS in neoplastic colon obstruction may reduce morbidity and need for a stoma compared with ES, concern has been raised, about long-term survival.
METHODS


Individuals affected by left-sided malignant large-bowel obstruction were enrolled from 5 European hospitals and randomly assigned (1:1 ratio) to receive SBTS or ES. The computer-generated randomization sequence was stratified by center on cT and concealed by the use of a web-based application. Investigators and participants were unmasked to treatment assignment. The secondary outcomes analyzed here were OS, TTP, and DFS. Analysis was by intention to treat. This study is registered, ID-code NCT00591695.
RESULTS


Between March 2008 and November 2015, 144 patients were randomly assigned to undergo either SBTS or ES; 115 (SBTS n = 56, ES n = 59) were eligible for analysis, while 20 participants were excluded for a benign disease, 1 for unavailability of the endoscopist while 8 withdrew from the trial. With a median follow-up of 37 months (range 1-62), no difference was observed in the SBTS group compared with ES in terms of OS (HR 0.93 (95% CI 0.49-1.76), P = 0.822), TTP (HR 0.81 (95% CI 0.42-1.54), P = 0.512), and DFS (HR 1.01 (95% CI 0.56-1.81), P = 0.972). Planned subgroup analysis showed no difference in respect to age, sex, American Society for Anesthesiology score, body mass index, and pT between SBTS and ES groups. Those participants randomized for the SBTS group whose obstruction was located in the descending colon had a better TTP compared with ES group (HR 0.44 (95% CI 0.20-0.97), P = 0.042), but no difference was observed in terms of OS (HR 0.73 (95% CI 0.33-1.63), P = 0.442) and DFS (HR 0.68 (95% CI 0.34-1.34), P = 0.261) in the same individuals.
CONCLUSIONS


This randomized controlled trial shows that, although not powered for these seconday outcomes, OS, TTP, and DFS did not differ between groups at a minimum follow-up of 36 months.",2020,"Those participants randomized for the SBTS group whose obstruction was located in the descending colon had a better TTP compared with ES group (HR 0.44 (95% CI 0.20-0.97), P = 0.042), but no difference was observed in terms of OS (HR 0.73 (95% CI 0.33-1.63), P = 0.442) and DFS (HR 0.68 (95% CI 0.34-1.34), P = 0.261) in the same individuals.
","['Between March 2008 and November 2015', '115 (SBTS n = 56, ES n = 59) were eligible for analysis, while 20 participants were excluded for a benign disease, 1 for unavailability of the endoscopist while 8 withdrew from the trial', '144 patients', 'Malignant Left-sided Colonic Obstruction', 'Individuals affected by left-sided malignant large-bowel obstruction were enrolled from 5 European hospitals and randomly assigned (1:1 ratio) to receive']","['SBTS or ES', 'SBTS', 'stenting as bridge-to-surgery (SBTS) versus emergency surgery (ES']","['obstruction', 'DFS', 'OS', 'TTP', 'overall (OS), time to progression (TTP), and disease-free survival (DFS', 'OS, TTP, and DFS']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0686905', 'cui_str': 'Unavailability'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0235328', 'cui_str': 'Obstruction of colon'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0460048', 'cui_str': 'Large bowel obstruction'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",59.0,0.384575,"Those participants randomized for the SBTS group whose obstruction was located in the descending colon had a better TTP compared with ES group (HR 0.44 (95% CI 0.20-0.97), P = 0.042), but no difference was observed in terms of OS (HR 0.73 (95% CI 0.33-1.63), P = 0.442) and DFS (HR 0.68 (95% CI 0.34-1.34), P = 0.261) in the same individuals.
","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Arezzo', 'Affiliation': 'Department of Surgical Sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Forcignanò', 'Affiliation': 'Department of Surgical Sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Marco Augusto', 'Initials': 'MA', 'LastName': 'Bonino', 'Affiliation': 'Department of Surgical Sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Balagué', 'Affiliation': 'Surgical Department, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Targarona', 'Affiliation': 'Surgical Department, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Borghi', 'Affiliation': 'ASO Santa Croce e Carle, Cuneo, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Giraudo', 'Affiliation': 'ASO Santa Croce e Carle, Cuneo, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Ghezzo', 'Affiliation': 'ASO Santa Croce e Carle, Cuneo, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Passera', 'Affiliation': 'Department of Medical sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Morino', 'Affiliation': 'Department of Surgical Sciences, University of Torino, Torino, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004324']
1428,32835443,Unilateral versus bilateral sacral neuromodulation test in the treatment of refractory idiopathic overactive bladder: A randomized controlled pilot trial.,"AIM


To compare treatment success rate in terms of improvement of bladder overactivity between unilateral and bilateral sacral neuromodulation testing.
METHODS


A multicentric, parallel, randomized, open pilot trial (October 2012-September 2017) was conducted. Participants presented primary overactive bladder resistant to first-line treatments. Patients were excluded in case of secondary bladder, pelvic, or neurological condition. Patients were randomized between bilateral testing (n = 28) or unilateral testing (n = 27), to determine the best functional response before final implantation. The primary outcome was the rate of patients presenting at least 50% of clinical improvement at 1 month on urinary frequency, number of urge incontinence episodes or number of urinary urgency episodes. Symptom severity, implantation success rate, uroflowmetry, device tolerance, complications, and quality of life were also assessed.
RESULTS


Fifty-five patients have been included. The rate of patients presenting at least one significant clinical improvement at month 1 was 62% in the bilateral group versus 84% in the unilateral group (P = .0891), RR = 0.74 (0.51; 1.07). There was no significant difference between bilateral and unilateral groups in terms of improvement of urinary frequency (0% and 17%; P = .1115), number of urge incontinence episodes (52% and 63%; P = .4929) or number of urinary urgency episodes (57% and 74%; P = .2411). More complications were reported in the bilateral group than in the unilateral group (9 [47%] vs 4 [16%], respectively; P = .0239).
CONCLUSION


Systematic bilateral sacral neuromodulation testing before final implantation did not appear to increase success rate compared with unilateral stimulation in the treatment of overactive bladder.",2020,"There was no significant difference between bilateral and unilateral groups in terms of improvement of urinary frequency (0% and 17%; P = .1115), number of urge incontinence episodes (52% and 63%; P = .4929) or number of urinary urgency episodes (57% and 74%; P = .2411).","['Participants presented primary overactive bladder resistant to first-line treatments', 'Patients were excluded in case of secondary bladder, pelvic, or neurological condition', 'Fifty-five patients have been included', 'refractory idiopathic overactive bladder']","['bilateral testing (n\u2009=\u200928) or unilateral testing', 'Unilateral versus bilateral sacral neuromodulation test']","['rate of patients presenting at least one significant clinical improvement', 'number of urge incontinence episodes', 'success rate', 'number of urinary urgency episodes', 'urinary frequency', 'Symptom severity, implantation success rate, uroflowmetry, device tolerance, complications, and quality of life', 'urinary frequency, number of urge incontinence episodes or number of urinary urgency episodes', 'More complications', 'rate of patients presenting at least 50% of clinical improvement']","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0036037', 'cui_str': 'Bone structure of sacrum'}, {'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0150045', 'cui_str': 'Urge incontinence of urine'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.134808,"There was no significant difference between bilateral and unilateral groups in terms of improvement of urinary frequency (0% and 17%; P = .1115), number of urge incontinence episodes (52% and 63%; P = .4929) or number of urinary urgency episodes (57% and 74%; P = .2411).","[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Wagner', 'Affiliation': 'Department of Urology and Andrology, CHU Nîmes, Univ Montpellier, Nîmes, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Alonso', 'Affiliation': 'Department of Biostatistics Clinical Epidemiology, Public Health and Innovation in Methodology (BESPIM), CHU Nîmes, Univ Montpellier, Nîmes, France.'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Le Normand', 'Affiliation': 'Department of Urology and Andrology, CHU Nantes, Nantes, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Faix', 'Affiliation': 'Department of Urology, Clinique Beau Soleil, Montpellier, France.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kabani', 'Affiliation': 'Department of Biostatistics Clinical Epidemiology, Public Health and Innovation in Methodology (BESPIM), CHU Nîmes, Univ Montpellier, Nîmes, France.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Castelli', 'Affiliation': 'Department of Biostatistics Clinical Epidemiology, Public Health and Innovation in Methodology (BESPIM), CHU Nîmes, Univ Montpellier, Nîmes, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Gamé', 'Affiliation': 'Department of Urology, University Hospital of Toulouse, Toulouse, France.'}, {'ForeName': 'Jean-Nicolas', 'Initials': 'JN', 'LastName': 'Cornu', 'Affiliation': 'Department of Urology, University Hospital of Rouen, Rouen, France.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Bey', 'Affiliation': 'Department of Urology and Andrology, CHU Nîmes, Univ Montpellier, Nîmes, France.'}]",Neurourology and urodynamics,['10.1002/nau.24476']
1429,32835895,A twelve-month follow-up of an information communication technology delivered intervention for children with autism spectrum disorder living in regional Australia.,"This study investigated the long-term follow-up of an information communication techonology based intervention, the Therapeutic Outcomes By You application, for children with autism spectrum disorder living in regional Australia. Fifteen participants who completed a three-month randomised controlled trial of the Therapeutic Outcomes By You were assessed at least 12 months post-intervention to determine the maintenance or continued improvement of their language and social communication skills. Findings demonstrate the receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder improved during the three-month intervention period and were maintained at least 12 months after ceasing the Therapeutic Outcomes By You app intervention.",2020,"Findings demonstrate the receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder improved during the three-month intervention period and were maintained at least 12 months after ceasing the Therapeutic Outcomes By You app intervention.","['Fifteen participants who completed a three-month randomised controlled trial of the Therapeutic Outcomes', 'children with autism spectrum disorder living in regional Australia']",[],"['receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]",[],"[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]",15.0,0.0425543,"Findings demonstrate the receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder improved during the three-month intervention period and were maintained at least 12 months after ceasing the Therapeutic Outcomes By You app intervention.","[{'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Parsons', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia. Electronic address: dave.parsons@curtin.edu.au.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Vaz', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia.'}, {'ForeName': 'Hoe', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Robinson', 'Affiliation': 'Kids are Kids!, Australia.'}, {'ForeName': 'Reinie', 'Initials': 'R', 'LastName': 'Cordier', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia; Department of Social Work, Education and Community Wellbeing, Northumbria University, Newcastle upon Tyne, United Kingdom.'}]",Research in developmental disabilities,['10.1016/j.ridd.2020.103743']
1430,31645648,A six-gene leukemic stem cell score identifies high risk pediatric acute myeloid leukemia.,"Recently, mRNA-expression signature enriched in LSCs was used to create a 17-gene leukemic stem cell (LSC17) score predictive of prognosis in adult AML. By fitting a Cox-LASSO regression model to the clinical outcome and gene-expression levels of LSC enriched genes in 163 pediatric participants of the AML02 multi-center clinical trial (NCT00136084), we developed a six-gene LSC score of prognostic value in pediatric AML (pLSC6). In the AML02 cohort, the 5-year event-free survival (EFS) of patients within low-pLSC6 group (n = 97) was 78.3 (95% CI = 70.5-86.9%) as compared with 34.5(95% CI = 24.7-48.2 %) in patients within high-pLSC6 group (n = 66 subjects), p < 0.00001. pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age. pLSC6 formula developed in the AML02 cohort was validated in the pediatric AML-TARGET project data (n = 205), confirming its prognostic value in both single-predictor and multiple-predictor Cox regression models. In both cohorts, pLSC6 predicted outcome of transplant patients, suggesting it as a useful criterion for transplant referrals. Our results suggest that pLSC6 score holds promise in redefining initial risk-stratification and identifying poor risk AML thereby providing guidance for developing novel treatment strategies.",2020,"pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age.","['risk pediatric acute myeloid leukemia', '163 pediatric participants']",['pLSC6'],"['EFS and overall survival (OS', '5-year event-free survival (EFS']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}]",[],"[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}]",163.0,0.0725067,"pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age.","[{'ForeName': 'Abdelrahman H', 'Initials': 'AH', 'LastName': 'Elsayed', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Rafiee', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Xueyuan', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Raimondi', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Downing', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Ribeiro', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Tanja A', 'Initials': 'TA', 'LastName': 'Gruber', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Sharyn', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': 'Department of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Klco', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Rubnitz', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Pounds', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Jatinder K', 'Initials': 'JK', 'LastName': 'Lamba', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA. jlamba@cop.ufl.edu.'}]",Leukemia,['10.1038/s41375-019-0604-8']
1431,32841169,Exploring the impact of pain management programme attendance on complex regional pain syndrome (CRPS) patients' decision making regarding immunosuppressant treatment to manage their chronic pain condition.,"Objectives Complex regional pain syndrome (CRPS) is a rare chronic pain condition for which no curative treatment exists. Patients in tertiary centres are often required to make decisions about treatment options. This study was conducted to explore how prior attendance of a pain management program might alter patients' decision making processes. Methods This qualitative study uses focus groups to gather patient views on an immunosuppressant drug treatment (mycophenolate) for the management of CRPS. Participants were allocated to one of three focus groups based on their treatment journey; Group 1 (n=3) were involved in a recent mycophenolate drug trial; Group 2 (n=5) were neither involved in the trial nor attended a Pain Management Programme (PMP); Group 3 (n=6) were not involved in the trial but had attended a PMP. Outcomes were considered within the framework of Leventhal's Common Sense Model (CSM) in relation to the decision making process. Results Thematic analysis identified differing themes for each group. Group 1: (1) Medication as a positive form of treatment, (2) The trial/drug and (3) Pacing. Group 2: (1) Medication as form of treatment, (2) Other forms of support/treatment and (3) Side effects of mycophenolate. Group 3: (1) Varied view of medication, (2) Consideration of other forms of support and (3) Side effects. Conclusions Attendance on a PMP might provide patients with skills to better manage uncertainty when faced with various treatment options. Leventhal's model goes some way to explaining this. The specific importance of, and benefit from understanding pacing when commencing an effective drug treatment for chronic pain became apparent.",2020,Participants were allocated to one of three focus groups based on their treatment journey; Group 1 (n=3) were involved in a recent mycophenolate drug trial; Group 2 (n=5) were neither involved in the trial nor attended a Pain Management Programme (PMP); Group 3 (n=6) were not involved in the trial but had attended a PMP.,['complex regional pain syndrome (CRPS) patients'],"['immunosuppressant drug treatment (mycophenolate', 'pain management programme attendance', 'mycophenolate drug trial; Group 2 (n=5) were neither involved in the trial nor attended a Pain Management Programme (PMP', 'pain management program', 'mycophenolate']",[],"[{'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],6.0,0.0247237,Participants were allocated to one of three focus groups based on their treatment journey; Group 1 (n=3) were involved in a recent mycophenolate drug trial; Group 2 (n=5) were neither involved in the trial nor attended a Pain Management Programme (PMP); Group 3 (n=6) were not involved in the trial but had attended a PMP.,"[{'ForeName': 'Calum', 'Initials': 'C', 'LastName': 'Murray', 'Affiliation': 'The Walton Centre NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Harrison', 'Affiliation': 'The Walton Centre NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goebel', 'Affiliation': 'The Walton Centre NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Twiddy', 'Affiliation': 'The Walton Centre NHS Foundation Trust, Liverpool, L9 7LJ,UK.'}]",Scandinavian journal of pain,['10.1515/sjpain-2019-0142']
1432,32841825,A randomized study of CrossFit Kids for fostering fitness and academic outcomes in middle school students.,"Within the context of school-based physical education (PE), a strength and conditioning program called CrossFit Kids (CFK) has emerged as a potential intervention for positively impacting students. The purpose of this study was to evaluate through a randomized-controlled trial how academic and health-related fitness outcomes differed for middle school students (age = 12.73; 55.3 % male) who participated in a school-based CFK program (n=72) as compared to a group of students who participated in PE class (n=72). Questionnaire data were collected twice across the 9-month academic year and combined with FitnessGram and grade data. Students in both the intervention and comparison groups increased in health-related fitness outcomes (all p values < .017), and there was a significant treatment group by time interaction on school-reported grades [F(1, 124) = 7.270, p = .008, η_P^2 = .055]. Significant gender by time interaction effects were found for the relationship between CFK or PE participation and health-related fitness outcomes, but there were no significant interaction effects by gender on academic outcomes. Because developmental outcomes are conditional and result from the coaction of many factors, the findings suggest that some elements of CFK might be beneficial to build skills yet disadvantageous to academic outcomes.",2020,"Students in both the intervention and comparison groups increased in health-related fitness outcomes (all p values < .017), and there was a significant treatment group by time interaction on school-reported grades [F(1, 124) = 7.270, p = .008, η_P^2 = .055].","['middle school students (age = 12.73; 55.3 % male) who participated in a school-based CFK program (n=72) as compared to a group of students who participated in PE class (n=72', 'middle school students']","['school-based physical education (PE), a strength and conditioning program called CrossFit Kids (CFK', 'CrossFit Kids']","['health-related fitness outcomes', 'Questionnaire data', 'fostering fitness and academic outcomes']","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}]",,0.0283754,"Students in both the intervention and comparison groups increased in health-related fitness outcomes (all p values < .017), and there was a significant treatment group by time interaction on school-reported grades [F(1, 124) = 7.270, p = .008, η_P^2 = .055].","[{'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Garst', 'Affiliation': 'Department of Parks, Recreation, and Tourism Management, Clemson University, USA. Electronic address: bgarst@clemson.edu.'}, {'ForeName': 'Edmond P', 'Initials': 'EP', 'LastName': 'Bowers', 'Affiliation': 'Department of Parks, Recreation, and Tourism Management, Clemson University, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Stephens', 'Affiliation': 'Department of Parks, Recreation, and Tourism Management, Clemson University, USA.'}]",Evaluation and program planning,['10.1016/j.evalprogplan.2020.101856']
1433,32853559,"Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


The anti-progesterone drug mifepristone and the prostaglandin misoprostol can be used to treat missed miscarriage. However, it is unclear whether a combination of mifepristone and misoprostol is more effective than administering misoprostol alone. We investigated whether treatment with mifepristone plus misoprostol would result in a higher rate of completion of missed miscarriage compared with misoprostol alone.
METHODS


MifeMiso was a multicentre, double-blind, placebo-controlled, randomised trial in 28 UK hospitals. Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent. Participants were randomly assigned (1:1) to a single dose of oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol 800 μg 2 days later. Randomisation was managed via a secure web-based randomisation program, with minimisation to balance study group assignments according to maternal age (<30 years vs ≥30 years), body-mass index (<35 kg/m 2 vs ≥35 kg/m 2 ), previous parity (nulliparous women vs parous women), gestational age (<70 days vs ≥70 days), amount of bleeding (Pictorial Blood Assessment Chart score; ≤2 vs ≥3), and randomising centre. Participants, clinicians, pharmacists, trial nurses, and midwives were masked to study group assignment throughout the trial. The primary outcome was failure to spontaneously pass the gestational sac within 7 days after random assignment. Primary analyses were done according to intention-to-treat principles. The trial is registered with the ISRCTN registry, ISRCTN17405024.
FINDINGS


Between Oct 3, 2017, and July 22, 2019, 2595 women were identified as being eligible for the MifeMiso trial. 711 women were randomly assigned to receive either mifepristone and misoprostol (357 women) or placebo and misoprostol (354 women). 696 (98%) of 711 women had available data for the primary outcome. 59 (17%) of 348 women in the mifepristone plus misoprostol group did not pass the gestational sac spontaneously within 7 days versus 82 (24%) of 348 women in the placebo plus misoprostol group (risk ratio [RR] 0·73, 95% CI 0·54-0·99; p=0·043). 62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021). We found no difference in incidence of adverse events between the study groups.
INTERPRETATION


Treatment with mifepristone plus misoprostol was more effective than misoprostol alone in the management of missed miscarriage. Women with missed miscarriage should be offered mifepristone pretreatment before misoprostol to increase the chance of successful miscarriage management, while reducing the need for miscarriage surgery.
FUNDING


UK National Institute for Health Research Health Technology Assessment Programme.",2020,"62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021).","['2595 women were identified as being eligible for the MifeMiso trial', '59 (17%) of 348 women in the', '696 (98%) of 711 women had available data for the primary outcome', 'Women with missed miscarriage', '354 women', 'Between Oct 3, 2017, and July 22, 2019', '28 UK hospitals', '62 (17%) of 355 women in the', 'maternal age (<30 years vs ≥30 years), body-mass index (<35 kg/m 2 vs ≥35 kg/m 2 ), previous parity (nulliparous women vs parous women), gestational age (<70 days vs ≥70 days), amount of bleeding (Pictorial Blood Assessment Chart score; ≤2 vs ≥3), and randomising centre', 'missed miscarriage (MifeMiso', '711 women', 'Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent']","['mifepristone and misoprostol', 'mifepristone plus misoprostol', 'Mifepristone and misoprostol', 'prostaglandin misoprostol', 'misoprostol', 'mifepristone', 'placebo', 'placebo and misoprostol', 'placebo plus misoprostol', 'oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol']","['chance of successful miscarriage management', 'failure to spontaneously pass the gestational sac', 'surgical intervention', 'incidence of adverse events', 'gestational sac spontaneously', 'rate of completion of missed miscarriage']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0000814', 'cui_str': 'Missed miscarriage'}, {'cui': 'C0069304', 'cui_str': 'POU5F1 protein, human'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0948766', 'cui_str': 'Ultrasound pelvis'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1126026', 'cui_str': 'Mifepristone 200 MG'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0553498', 'cui_str': 'Gestation Sac'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0000814', 'cui_str': 'Missed miscarriage'}]",2595.0,0.70251,"62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021).","[{'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Chu', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Devall', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. Electronic address: a.j.devall@bham.ac.uk.'}, {'ForeName': 'Leanne E', 'Initials': 'LE', 'LastName': 'Beeson', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Pollyanna', 'Initials': 'P', 'LastName': 'Hardy', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Versha', 'Initials': 'V', 'LastName': 'Cheed', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Yongzhong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Roberts', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'C Okeke', 'Initials': 'CO', 'LastName': 'Ogwulu', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Williams', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Jones', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jenny H', 'Initials': 'JH', 'LastName': 'La Fontaine Papadopoulos', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Bender-Atik', 'Affiliation': 'The Miscarriage Association, Wakefield, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Brewin', 'Affiliation': ""Tommy's Charity, London, UK.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hinshaw', 'Affiliation': 'Sunderland Royal Hospital, South Tyneside and Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Choudhary', 'Affiliation': 'Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Sunderland Royal Hospital, South Tyneside and Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Naftalin', 'Affiliation': 'University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Nunes', 'Affiliation': 'West Middlesex University Hospital, Chelsea and Westminster NHS Foundation Trust, London, UK.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Oliver', 'Affiliation': ""St Michael's Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.""}, {'ForeName': 'Feras', 'Initials': 'F', 'LastName': 'Izzat', 'Affiliation': 'University Hospital Coventry, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Kalsang', 'Initials': 'K', 'LastName': 'Bhatia', 'Affiliation': 'Burnley General Hospital, East Lancashire Hospitals NHS Trust, Burnley, UK.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Hassan', 'Affiliation': ""Birmingham Women's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Yadava', 'Initials': 'Y', 'LastName': 'Jeve', 'Affiliation': ""Birmingham Women's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Hamilton', 'Affiliation': ""Guy's and St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Deb', 'Affiliation': ""Queen's Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK.""}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Bottomley', 'Affiliation': 'University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Ross', 'Affiliation': ""Kings College Hospital, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Watkins', 'Affiliation': ""Liverpool Women's Hospital, Liverpool Women's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Princess Royal Hospital, Shrewsbury and Telford NHS Trust, Telford, UK.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheong', 'Affiliation': 'Department of Reproductive Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Chitra S', 'Initials': 'CS', 'LastName': 'Kumar', 'Affiliation': 'NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Small', 'Affiliation': 'Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Pringle', 'Affiliation': 'NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Hodge', 'Affiliation': 'Singleton Hospital, Swansea Bay University Health Board, Swansea, UK.'}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Shahid', 'Affiliation': 'Barts Health NHS Trust, The Royal London Hospital, London, UK.'}, {'ForeName': 'Ioannis D', 'Initials': 'ID', 'LastName': 'Gallos', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Horne', 'Affiliation': 'Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Quenby', 'Affiliation': 'Biomedical Research Unit in Reproductive Health, University of Warwick, Warwick, UK.'}, {'ForeName': 'Arri', 'Initials': 'A', 'LastName': 'Coomarasamy', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31788-8']
1434,32860422,Benefit-Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment-Resistant Depression.,"This post hoc analysis assessed the benefit-risk profile of esketamine nasal spray + oral antidepressant (AD) induction and maintenance treatment in patients with treatment-resistant depression (TRD). The Benefit-Risk Action Team framework was utilized to assess the benefit-risk profile using data from three induction studies and one maintenance study. Benefits were proportion of remitters or responders in induction studies and proportion of stable remitters or stable responders who remained relapse-free in the maintenance study. Risks were death, suicidal ideation, most common adverse events (AEs), and potential long-term risks. Per 100 patients on esketamine + AD vs. AD + placebo in induction therapy, 5-21 additional patients would remit and 14-17 additional patients would respond. In maintenance therapy, 19-32 fewer relapses would occur with esketamine. In both cases, there was little difference in serious or severe common AEs (primarily dissociation, vertigo, and dizziness). These findings support a positive benefit-risk balance for esketamine + AD as induction and maintenance treatment in patients with TRD.",2020,"In both cases, there was little difference in serious or severe common AEs (primarily dissociation, vertigo and dizziness).","['patients with TRD', 'patients with treatment-resistant depression (TRD', 'Per 100 patients on']","['esketamine nasal spray+oral antidepressant (AD) induction and maintenance treatment', 'Esketamine Nasal Spray versus Placebo', 'esketamine+AD vs AD+placebo']","['death, suicidal ideation, most common adverse events (AEs), and potential long-term risks', 'serious or severe common AEs (primarily dissociation, vertigo and dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086168', 'cui_str': 'Dissociation - mental defense mechanism'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",,0.0534257,"In both cases, there was little difference in serious or severe common AEs (primarily dissociation, vertigo and dizziness).","[{'ForeName': 'Eva G', 'Initials': 'EG', 'LastName': 'Katz', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hough', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Doherty', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Rosanne', 'Initials': 'R', 'LastName': 'Lane', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Jaskaran', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Janssen Research & Development, LLC, San Diego, California, USA.'}, {'ForeName': 'Bennett', 'Initials': 'B', 'LastName': 'Levitan', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2024']
1435,32865857,Effects of the biopsychosocial functional activity program on cognitive function for community older adults with mild cognitive impairment: A cluster-randomized controlled trial.,"Early preventive interventions may delay the onset of dementia for people with mild cognitive impairment. This study was designed to examine the effects of the biopsychosocial functional activity program on the cognitive function of community middle to older adults with mild cognitive impairment. A cluster-randomized controlled trial was conducted. The experimental group received a 12-month biopsychosocial functional activity program intervention that contained two phases. The first phase was a 6-week teaching program followed by a second-phase home follow-up phase. The measurement was carried out at baseline, 6 months and 12 months after the biopsychosocial functional activity program. The measurement tool was the Chinese version of the Saint Louis University Mental Status Examination. The Generalized Estimating Equations statistical approach was used to analyze the data. The experimental group showed significant short-term and continuous improvement in overall cognitive function in the immediate- and short-term memory domain while the domain of attention and executive function showed improvement on the 12-month measurement compared to the control group. Yet, there was no significant improvement overall and in the three domains of cognitive function for the control group. The findings may become references for advancing the dementia prevention program for communities as well as the national policies for dementia prevention programs.",2020,The experimental group showed significant short-term and continuous improvement in overall cognitive function in the immediate and short-term memory domain while the domain of attention and executive function showed improvement on the 12-month measurement compared to the control group.,"['people with Mild Cognitive Impairment', 'community middle to older adults with Mild Cognitive Impairment', 'community older adults with Mild Cognitive Impairment']","['12-month bio-psycho-social functional activity program intervention', 'bio-psycho-social functional activity program']","['overall cognitive function', 'cognitive function', 'domain of attention and executive function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.0185851,The experimental group showed significant short-term and continuous improvement in overall cognitive function in the immediate and short-term memory domain while the domain of attention and executive function showed improvement on the 12-month measurement compared to the control group.,"[{'ForeName': 'Yen-Chun', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, Chang Jung Christian University, Tainan, Taiwan.'}, {'ForeName': 'Chi-Jane', 'Initials': 'CJ', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yin-Fan', 'Initials': 'YF', 'LastName': 'Chang', 'Affiliation': 'Department of Family Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Jing-Jy', 'Initials': 'JJ', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}]",Nursing & health sciences,['10.1111/nhs.12772']
1436,32831169,A stepped-wedge randomised trial on the impact of early ART initiation on HIV-patients' economic outcomes in Eswatini.,"Background:  Since 2015, the World Health Organisation (WHO) recommends immediate initiation of antiretroviral therapy (ART) for all HIV-positive patients. Epidemiological evidence points to important health benefits of immediate ART initiation; however, the policy's impact on the economic aspects of patients' lives remains unknown.  Methods:  We conducted a stepped-wedge cluster-randomised controlled trial in Eswatini to determine the causal impact of immediate ART initiation on patients' individual- and household-level economic outcomes. Fourteen healthcare facilities were non-randomly matched into pairs and then randomly allocated to transition from the standard of care (ART eligibility at CD4 counts of <350 cells/mm 3  until September 2016 and <500 cells/mm 3  thereafter) to the 'Early Initiation of ART for All' (EAAA) intervention at one of seven timepoints. Patients, healthcare personnel, and outcome assessors remained unblinded. Data were collected via standardised paper-based surveys with HIV-positive adults who were neither pregnant nor breastfeeding. Outcomes were patients' time use, employment status, household expenditures, and household living standards.  Results:  A total sample of 3019 participants were interviewed over the duration of the study. The mean number of participants approached at each facility per time step varied from 4 to 112 participants. Using mixed-effects negative binomial regressions accounting for time trends and clustering at the level of the healthcare facility, we found no significant difference between study arms for any economic outcome. Specifically, the EAAA intervention had no significant effect on non-resting time use (RR = 1.00 [CI: 0.96, 1.05, p=0.93]) or income-generating time use (RR = 0.94, [CI: 0.73,1.20, p=0.61]). Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93 [CI: 0.82, 1.04, p=0.21] and 0.92 [CI: 0.79, 1.06, p=0.26], respectively. We also found no significant treatment effect on households' asset ownership and living standards (RR = 0.96, [CI 0.92, 1.00, p=0.253]). Lastly, there was no evidence of heterogeneity in effect estimates by patients' sex, age, education, timing of HIV diagnosis and ART initiation.  Conclusions:  Our findings do not provide evidence that should discourage further investments into scaling up immediate ART for all HIV patients.  Funding:  Funded by the Dutch Postcode Lottery in the Netherlands, Alexander von Humboldt-Stiftung (Humboldt-Stiftung), the Embassy of the Kingdom of the Netherlands in South Africa/Mozambique, British Columbia Centre of Excellence in Canada, Doctors Without Borders (MSF USA), National Center for Advancing Translational Sciences of the National Institutes of Health and Joachim Herz Foundation.  Clinical trial number: ClinicalTrials.gov, NCT02909218 and NCT03789448.",2020,"Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93","['Fourteen healthcare facilities', ""HIV patients' economic welfare in Eswatini"", ""patients' economic welfare"", 'A total sample of 3,019 participants were interviewed over the duration of the study']","['immediate ART initiation', 'antiretroviral therapy (ART']","['Employment and household expenditures', 'time use, employment status, household expenditures and household wealth', 'non-resting time use']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0038983', 'cui_str': 'Swaziland'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0242271', 'cui_str': 'Employment status'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",3019.0,0.412335,"Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93","[{'ForeName': 'Janina Isabel', 'Initials': 'JI', 'LastName': 'Steinert', 'Affiliation': 'Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Shaukat', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Khudzie', 'Initials': 'K', 'LastName': 'Mlambo', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Fiona J', 'Initials': 'FJ', 'LastName': 'Walsh', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Mafara', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lejeune', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Cebele', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hettema', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Osondu', 'Initials': 'O', 'LastName': 'Ogbuoji', 'Affiliation': 'Center for Policy Impact in Global Health, Duke Global Health Institute, Duke University, Durham, United States.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Vollmer', 'Affiliation': 'University of Goettingen, Goettingen, Germany.'}, {'ForeName': 'Jan-Walter', 'Initials': 'JW', 'LastName': 'De Neve', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Sikhathele', 'Initials': 'S', 'LastName': 'Mazibuko', 'Affiliation': 'Ministry of Health of the Kingdom of Eswatini, Mbabane, Eswatini.'}, {'ForeName': 'Velephi', 'Initials': 'V', 'LastName': 'Okello', 'Affiliation': 'Ministry of Health of the Kingdom of Eswatini, Mbabane, Eswatini.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Geldsetzer', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.'}]",eLife,['10.7554/eLife.58487']
1437,32838982,"Pharmacokinetics of ketamine and its major metabolites norketamine, hydroxynorketamine, and dehydronorketamine: a model-based analysis.","BACKGROUND


Recent studies show activity of ketamine metabolites, such as hydroxynorketamine, in producing rapid relief of depression-related symptoms and analgesia. To improve our understanding of the pharmacokinetics of ketamine and metabolites norketamine, dehydronorketamine, and hydroxynorketamine, we developed a population pharmacokinetic model of ketamine and metabolites after i.v. administration of racemic ketamine and the S-isomer (esketamine). Pharmacokinetic data were derived from an RCT on the efficacy of sodium nitroprusside (SNP) in reducing the psychotomimetic side-effects of ketamine in human volunteers.
METHODS


Three increasing i.v. doses of esketamine and racemic ketamine were administered to 20 healthy volunteers, and arterial plasma samples were obtained for measurement of ketamine and metabolites. Subjects were randomised to receive esketamine/SNP, esketamine/placebo, racemic ketamine/SNP, and racemic ketamine/placebo on four separate occasions. The time-plasma concentration data of ketamine and metabolites were analysed using a population compartmental model approach.
RESULTS


The pharmacokinetics of ketamine and metabolites were adequately described by a seven-compartment model with two ketamine, norketamine, and hydroxynorketamine compartments and one dehydronorketamine compartment with metabolic compartments in-between ketamine and norketamine, and norketamine and dehydronorketamine main compartments. Significant differences were found between S- and R-ketamine enantiomer pharmacokinetics, with up to 50% lower clearances for the R-enantiomers, irrespective of formulation. Whilst SNP had a significant effect on ketamine clearances, simulations showed only minor effects of SNP on total ketamine pharmacokinetics.
CONCLUSIONS


The model is of adequate quality for use in future pharmacokinetic and pharmacodynamic studies into the efficacy and side-effects of ketamine and metabolites.
CLINICAL TRIAL REGISTRATION


Dutch Cochrane Center 5359.",2020,"Significant differences were found between S- and R-ketamine enantiomer pharmacokinetics, with up to 50% lower clearances for the R-enantiomers, irrespective of formulation.","['human volunteers', '20 healthy volunteers']","['esketamine/SNP, esketamine/placebo, racemic ketamine/SNP, and racemic ketamine/placebo', 'ketamine and norketamine, and norketamine and dehydronorketamine main compartments', 'SNP', 'ketamine', 'hydroxynorketamine, and dehydronorketamine', 'ketamine and metabolites norketamine, dehydronorketamine, and hydroxynorketamine', 'esketamine and racemic ketamine', 'racemic ketamine and the S-isomer (esketamine', 'sodium nitroprusside (SNP']","['time-plasma concentration data of ketamine and metabolites', 'ketamine clearances']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0037533', 'cui_str': 'Sodium nitroprusside'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0068996', 'cui_str': 'norketamine'}, {'cui': 'C1143885', 'cui_str': 'dehydronorketamine'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0022203', 'cui_str': 'Isomerism'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",20.0,0.0501973,"Significant differences were found between S- and R-ketamine enantiomer pharmacokinetics, with up to 50% lower clearances for the R-enantiomers, irrespective of formulation.","[{'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Kamp', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands. Electronic address: j.kamp@lumc.nl.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Jonkman', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'van Velzen', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Aarts', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Niesters', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Dahan', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Olofsen', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.06.067']
1438,32840337,"A comparison of the efficacy and tolerability of treating primary nocturnal enuresis with Solifenacin Plus Desmopressin, Tolterodine Plus Desmopressin, and Desmopressin alone: a randomized controlled clinical trial.","INTRODUCTION


Nocturnal enuresis (enuresis) is one of the most common developmental problems of childhood, which has often a familial basis, causes mental and psychological damage to the child and disrupts family solace.
OBJECTIVES


In this study, we compared therapeutic efficacy and tolerability of treating primary nocturnal enuresis (PNE) with solifenacin plus desmopressin, tolterodine plus desmopressin, and desmopressin alone. Because we don't have enough information about this comparison especially about solifenacin plus desmopressin.
PATIENTS AND METHODS


This clinical trial study was performed on 62 patients with enuresis aged 5-15 years who referred to the urology clinic of Imam Khomeini Hospital in Ahwaz in 2017-2018. Patients were randomly assigned to one of the three different therapeutic protocols and any participants were given a specific code. After that, we compared the therapeutic response and the level of satisfaction of each therapeutic group in different months. Data were analyzed using SPSS 22 software and descriptive and analytical statistics.
RESULTS


The mean age of patients was 8.70±66 years. In the therapeutic group with desmopressin and solifenacin, 19 of 20 patients (95%) achieved complete remission (1) after a 3-month treatment in comparison with monotherapy group in which 14 of 22 patients (63.63%) achieved complete remission; and in the combination therapy group of desmopressin and tolterodine, in the study and the evaluation of the consequences of 3-month treatment of this group, it was found that 17 of 20 patients (85%) had complete remission. Overall, the therapeutic response in combination therapy groups of desmopressin plus anticholinergic was higher than the monotherapy group of desmopressin alone.
CONCLUSION


Our results demonstrate that the combination of desmopressin and an anticholinergic agent is highly effective in treatment of children with PMNE. Although desmopressin has long been a first - line treatment for PMNE, desmopressin monotherapy often fails to achieve a successful response in patients with PMNE.",2021,"Overall, the therapeutic response in combination therapy groups of desmopressin plus anticholinergic was higher than the monotherapy group of desmopressin alone.
","['62 patients with enuresis aged 5-15 years who referred to the urology clinic of Imam Khomeini Hospital in Ahwaz in 2017-2018', 'patients with PMNE', 'Nocturnal enuresis (enuresis', 'children with PMNE']","['desmopressin and solifenacin', 'Solifenacin Plus Desmopressin, Tolterodine Plus Desmopressin, and Desmopressin alone', 'desmopressin', 'solifenacin plus desmopressin, tolterodine plus desmopressin, and desmopressin alone', 'anticholinergic agent', 'desmopressin and tolterodine', 'desmopressin plus anticholinergic']","['therapeutic efficacy and tolerability', 'therapeutic response', 'efficacy and tolerability', 'therapeutic response and the level of satisfaction', 'complete remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014394', 'cui_str': 'Enuresis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3812395', 'cui_str': 'Urology clinic'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0270327', 'cui_str': 'Nocturnal enuresis'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C1099677', 'cui_str': 'Solifenacin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",62.0,0.0172601,"Overall, the therapeutic response in combination therapy groups of desmopressin plus anticholinergic was higher than the monotherapy group of desmopressin alone.
","[{'ForeName': 'Parvin Mousavi', 'Initials': 'PM', 'LastName': 'Ghanavati', 'Affiliation': 'Golestan Hospital, Iran, Tehran, Republic of Islamic.'}, {'ForeName': 'Dinyar', 'Initials': 'D', 'LastName': 'Khazaeli', 'Affiliation': 'Ahvaz Jundishapur University, Ahvaz, Khuzestan, Iran, Tehran, Republic of Islamic.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Amjadzadeh', 'Affiliation': 'Ahvaz Jundishapur University, Ahvaz, Khuzestan, Iran, Tehran, Republic of Islamic.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2019.0448']
1439,32840417,Randomized Comparison of Pazopanib and Doxorubicin as First-Line Treatment in Patients With Metastatic Soft Tissue Sarcoma Age 60 Years or Older: Results of a German Intergroup Study.,"PURPOSE


Doxorubicin is a standard of care in patients with advanced, inoperable soft tissue sarcoma (STS). We tested whether pazopanib has efficacy comparable to that of doxorubicin in elderly patients with STS and offers superior tolerability for hematologic toxicity.
PATIENTS AND METHODS


Patients age 60 years or older without previous systemic treatment for progressive advanced or metastatic STS who had Eastern Cooperative Oncology Group performance status of 0 to 2 and adequate organ function were included. Treatment consisted of pazopanib 800 mg once per day or doxorubicin 75 mg/m 2  once every 3 weeks (≤ 6 cycles) after being randomly assigned in a 2:1 ratio. Noninferiority was assumed for progression-free survival (PFS), if the upper limit of the 95% CI for the hazard ratio (HR) was less than 1.8. Neutropenia and febrile neutropenia were key secondary end points. The European Organisation for Research and Treatment of Cancer (30-item) Quality of Life Questionnaire and geriatric assessment were used to measure patient-reported outcomes. Cox regression analysis and Kaplan-Meier curves were used for analysis.
RESULTS


Pazopanib and doxorubicin were given to 81 and 39 patients, respectively. The median age was 71 years (range, 60-88 years). PFS was noninferior (HR, 1.00; 95% CI, 0.65 to 1.53) and the incidence of grade 4 neutropenia and febrile neutropenia favored pazopanib. Objective response rates for pazopanib and doxorubicin were 12.3% and 15.4%, respectively. Overall survival did not differ significantly between arms (HR, 1.08; 95% CI, 0.68 to 1.72;  P  = .735). Geriatric assessment revealed 2 or more comorbidities in 15.8% of the patients and impairment of activities of daily living in 28.3% of patients.
CONCLUSION


Pazopanib was noninferior to doxorubicin, rendering pazopanib a putative therapeutic option in the first-line treatment of STS in patients age 60 years or older. The distinct adverse event profile may be used to counsel patients and tailor therapy to individual needs.",2020,"Overall survival did not differ significantly between arms (HR, 1.08; 95% CI, 0.68 to 1.72;  P  = .735).","['60 Years or Older', 'patients age 60 years or older', 'The median age was 71 years (range, 60-88 years', 'Patients age 60 years or older without previous systemic treatment for progressive advanced or metastatic STS who had Eastern Cooperative Oncology Group performance status of 0 to 2 and adequate organ function were included', 'elderly patients with STS', 'Patients With Metastatic Soft Tissue Sarcoma Age', 'patients with advanced, inoperable soft tissue sarcoma (STS']","['Pazopanib and doxorubicin', 'pazopanib 800 mg once per day or doxorubicin', 'Pazopanib', 'doxorubicin', 'pazopanib', 'pazopanib and doxorubicin', 'doxorubicin, rendering pazopanib', 'Pazopanib and Doxorubicin', 'Doxorubicin']","['Cancer (30-item) Quality of Life Questionnaire and geriatric assessment', 'Overall survival', 'activities of daily living', 'Neutropenia and febrile neutropenia', 'incidence of grade 4 neutropenia and febrile neutropenia', 'PFS', 'Objective response rates', 'progression-free survival (PFS']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}]","[{'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.104663,"Overall survival did not differ significantly between arms (HR, 1.08; 95% CI, 0.68 to 1.72;  P  = .735).","[{'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Clinic for Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Medical School Hannover, Hannover, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Karch', 'Affiliation': 'Institute for Biostatistics, Medical School Hannover, Hannover, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Schuler', 'Affiliation': 'Helios Clinic, Berlin, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'Department of General Medical Oncology, University Hospitals Leuven, Leuven Cancer Institute, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Kopp', 'Affiliation': 'Robert Bosch Centrum für Tumorerkrankungen Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bauer', 'Affiliation': 'Clinic for Internal Medicine (Tumor Research), University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Kasper', 'Affiliation': 'Sarcoma Unit, Mannheim University Medical Center, Mannheim, Germany.'}, {'ForeName': 'Lars H', 'Initials': 'LH', 'LastName': 'Lindner', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University Munich, Munich, Germany.'}, {'ForeName': 'Jens-Marcus', 'Initials': 'JM', 'LastName': 'Chemnitz', 'Affiliation': 'Community Hospital Middle Rine, Middle Rine, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Crysandt', 'Affiliation': 'University Hospital Aachen, Aachen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': 'University Hospital Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Steffen', 'Affiliation': 'University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Richter', 'Affiliation': 'University Hospital Carl Gustav Carus, University Cancer Center/Medical Department I, Dresden, Germany.'}, {'ForeName': 'Gerlinde', 'Initials': 'G', 'LastName': 'Egerer', 'Affiliation': 'University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Ivanyi', 'Affiliation': 'Clinic for Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Medical School Hannover, Hannover, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Zimmermann', 'Affiliation': 'Hannover Clinical Trial Center, Hannover, Germany.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Institute for Biostatistics, Medical School Hannover, Hannover, Germany.'}, {'ForeName': 'Annegret', 'Initials': 'A', 'LastName': 'Kunitz', 'Affiliation': 'Vivantes Clinic Berlin-Spandau, Berlin-Spandau, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00714']
1440,32840418,"Patient-Centered Outcomes in ARIEL3, a Phase III, Randomized, Placebo-Controlled Trial of Rucaparib Maintenance Treatment in Patients With Recurrent Ovarian Carcinoma.","PURPOSE


To investigate quality-adjusted progression-free survival (QA-PFS) and quality-adjusted time without symptoms or toxicity (Q-TWiST) in a post hoc exploratory analysis of the phase III ARIEL3 study of rucaparib maintenance treatment versus placebo.
PATIENTS AND METHODS


Patients with platinum-sensitive, recurrent ovarian carcinoma were randomly assigned to rucaparib (600 mg twice per day) or placebo. QA-PFS was calculated as progression-free survival function × the 3-level version of the EQ-5D questionnaire (EQ-5D-3L) index score function. Q-TWiST analyses were performed defining TOX as the mean duration in which a patient experienced grade ≥ 3 treatment-emergent adverse events (TEAEs) or the mean duration in which a patient experienced grade ≥ 2 TEAEs of nausea, vomiting, fatigue, and asthenia. Q-TWiST was calculated as μTOX × TOX + TWiST, with μTOX calculated using EQ-5D-3L data.
RESULTS


The visit cutoff was Apr 15, 2017. Mean QA-PFS was significantly longer with rucaparib versus placebo in the intent-to-treat (ITT) population (375 randomly assigned to rucaparib  v  189 randomly assigned to placebo; difference, 6.28 months [95% CI, 4.85 to 7.47 months]);  BRCA -mutant cohort (130 rucaparib  v  66 placebo; 9.37 months [95% CI, 6.65 to 11.85 months]); homologous recombination deficient (HRD) cohort (236 rucaparib  v  118 placebo; 7.93 months [95% CI, 5.93 to 9.53 months]); and  BRCA  wild-type/loss of heterozygosity (LOH) low patient subgroup (107 rucaparib  v  54 placebo; 2.71 months [95% CI, 0.31 to 4.44 months]). With TOX defined using grade ≥ 3 TEAEs, the difference in mean Q-TWiST (rucaparib  v  placebo) was 6.88 months (95% CI, 5.71 to 8.23 months), 9.73 months (95% CI, 7.10 to 11.94 months), 8.11 months (95% CI, 6.36 to 9.49 months), and 3.35 months (95% CI, 1.66 to 5.40 months) in the ITT population,  BRCA -mutant cohort, HRD cohort, and  BRCA  wild-type/LOH low patient subgroup, respectively. Q-TWiST with TOX defined using select grade ≥ 2 TEAEs also consistently favored rucaparib.
CONCLUSION


The significant differences in QA-PFS and Q-TWiST confirm the benefit of rucaparib versus placebo in all predefined cohorts.",2020,"Mean QA-PFS was significantly longer with rucaparib versus placebo in the intent-to-treat (ITT) population (375 randomly assigned to rucaparib  v  189 randomly assigned to placebo; difference, 6.28 months [95% CI, 4.85 to 7.47 months]);  ","['Patients With Recurrent Ovarian Carcinoma', 'Patients with platinum-sensitive, recurrent ovarian carcinoma']","['Rucaparib Maintenance Treatment', 'rucaparib versus placebo', 'placebo', 'rucaparib', 'Placebo']","['quality-adjusted progression-free survival (QA-PFS) and quality-adjusted time without symptoms or toxicity (Q-TWiST', 'nausea, vomiting, fatigue, and asthenia', 'Mean QA-PFS', 'mean Q-TWiST', 'QA-PFS', 'EQ-5D questionnaire (EQ-5D-3L) index score function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C3661315', 'cui_str': 'rucaparib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.300562,"Mean QA-PFS was significantly longer with rucaparib versus placebo in the intent-to-treat (ITT) population (375 randomly assigned to rucaparib  v  189 randomly assigned to placebo; difference, 6.28 months [95% CI, 4.85 to 7.47 months]);  ","[{'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oaknin', 'Affiliation': ""Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dean', 'Affiliation': 'St John of God Subiaco Hospital, Subiaco, WA, Australia.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'University of Milan-Bicocca and European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'Johanne I', 'Initials': 'JI', 'LastName': 'Weberpals', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Clamp', 'Affiliation': 'The Christie NHS Foundation Trust and University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Leary', 'Affiliation': ""Gustave Roussy Cancer Center, INSERM U981, and Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Villejuif, France.""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Holloway', 'Affiliation': 'AdventHealth Cancer Institute, Orlando, FL.'}, {'ForeName': 'Margarita Amenedo', 'Initials': 'MA', 'LastName': 'Gancedo', 'Affiliation': 'Oncology Center of Galicia, Doctor Camilo Veiras, La Coruña, Spain.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Fong', 'Affiliation': 'Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Goh', 'Affiliation': ""Royal Brisbane and Women's Hospital and University of Queensland, St Lucia, Australia.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'The Ohio State University, James Cancer Center, Columbus, OH.'}, {'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'Armstrong', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'García-Donas', 'Affiliation': 'HM Hospitales-Centro Integral Oncológico Hospital de Madrid Clara Campal, Madrid, Spain.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Swisher', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Meunier', 'Affiliation': 'Modus Outcomes, Lyon, France.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Goble', 'Affiliation': 'Clovis Oncology, Inc., Boulder, CO.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Cameron', 'Affiliation': 'Clovis Oncology UK, Ltd., Cambridge, United Kingdom.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Maloney', 'Affiliation': 'Clovis Oncology, Inc., Boulder, CO.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Mörk', 'Affiliation': 'Clovis Oncology Denmark, ApS, Copenhagen, Denmark.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Bedel', 'Affiliation': 'Clovis Oncology Switzerland, GmBH, Zurich, Switzerland.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'UCL Cancer Institute, University College London, and UCL Hospitals, London, United Kingdom.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03107']
1441,32833935,Racial Differences in the Effectiveness of a Multifactorial Telehealth Intervention to Slow Diabetic Kidney Disease.,"BACKGROUND


African Americans are significantly more likely than non-African Americans to have diabetes, chronic kidney disease, and uncontrolled hypertension, increasing their risk for kidney function decline.
OBJECTIVE


The objective of this study was to compare how African Americans and non-African Americans with diabetes responded to a multifactorial telehealth intervention designed to slow kidney function decline.
RESEARCH DESIGN


Secondary analysis of a randomized trial. Primary care patients (N=281, 56% African American) were allocated to either: (1) a multifactorial, pharmacist-delivered phone-based telehealth intervention focused on behavioral and medication management of diabetic kidney disease; or (2) an education control.
MEASURES


The primary study outcome was change in estimated glomerular filtration rate (eGFR). Linear mixed models were used to explore the moderating effect of race on the relationship between study arm and eGFR decline over time; the mean annual rate of eGFR decline was estimated by race and study arm.
RESULTS


Findings demonstrated a differential intervention effect on kidney function over time by race (Pinteraction=0.005). Among African Americans, the intervention arm had significantly greater preservation of eGFR over time than the control arm (difference in the annual rate of eGFR decline=1.5 mL/min/1.73 m; 95% confidence interval: 0.04, 3.02). For non-African Americans, the intervention arm had a faster decline in eGFR over time than the control arm (difference in the annual rate of eGFR decline=-1.7 mL/min/1.73 m; 95% confidence interval: -3.3, -0.02).
CONCLUSION


A multifactorial, pharmacist-delivered telehealth intervention for diabetic kidney disease may be more effective for slowing eGFR decline among African Americans than non-African Americans.",2020,"For non-African Americans, the intervention arm had a faster decline in eGFR over time than the control arm (difference in the annual rate of eGFR decline=-1.7 mL/min/1.73 m; 95% confidence interval: -3.3, -0.02).
","['African Americans and non-African Americans with diabetes', 'African Americans than non-African Americans', 'Slow Diabetic Kidney Disease', 'Primary care patients (N=281, 56% African American', 'African Americans']","['multifactorial, pharmacist-delivered phone-based telehealth intervention focused on behavioral and medication management of diabetic kidney disease; or (2) an education control', 'Multifactorial Telehealth Intervention', 'multifactorial telehealth intervention']","['preservation of eGFR', 'kidney function', 'estimated glomerular filtration rate (eGFR']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",,0.068358,"For non-African Americans, the intervention arm had a faster decline in eGFR over time than the control arm (difference in the annual rate of eGFR decline=-1.7 mL/min/1.73 m; 95% confidence interval: -3.3, -0.02).
","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Kobe', 'Affiliation': 'Duke University School of Medicine.'}, {'ForeName': 'Clarissa J', 'Initials': 'CJ', 'LastName': 'Diamantidis', 'Affiliation': 'Department of Population Health Sciences.'}, {'ForeName': 'Hayden B', 'Initials': 'HB', 'LastName': 'Bosworth', 'Affiliation': 'Department of Population Health Sciences.'}, {'ForeName': 'Clemontina A', 'Initials': 'CA', 'LastName': 'Davenport', 'Affiliation': 'Biostatistics and Bioinformatics.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Oakes', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine.'}, {'ForeName': 'Anastasia-Stefania', 'Initials': 'AS', 'LastName': 'Alexopoulos', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT).'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Pendergast', 'Affiliation': 'Biostatistics and Bioinformatics.'}, {'ForeName': 'Uptal D', 'Initials': 'UD', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Division of Nephrology, Duke University School of Medicine.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT).'}]",Medical care,['10.1097/MLR.0000000000001387']
1442,32835958,Enhancing extinction with response prevention via imagery-based counterconditioning: Results on conditioned avoidance and distress.,"BACKGROUND AND OBJECTIVES


Maladaptive avoidance is a core characteristic of anxiety-related disorders. Its reduction is often promoted using extinction with response prevention (ExRP) procedures, but these effects are often short-lived. Research has shown that pairing a feared stimulus with a stimulus of an incompatible valence (i.e., counterconditioning) may be effective in reducing fear. This laboratory study tested whether positive imagery during ExRP (i.e., imagery counterconditioning protocol) can also reduce avoidance.
METHODS


In the counterconditioning procedure, participants imagined a positive sound. There were four phases. First, participants were presented with squares on a computer screen of which one (CS+) was paired with an aversive sound and another (CS-) was not. Second, they learned to avoid the negative sound in the presence of the CS+, via a key press. Third, they were assigned to either the Counterconditioning (that was asked to imagine a positive sound during ExRP) or No Counterconditioning group (standard ExRP). Finally, they performed a test phase that consisted of two parts: in the first part, avoidance responses were available for each CS and in the second part, these responses were prevented.
RESULTS


The Counterconditioning intervention resulted in a short-lived reduction of distress associated with the CS+. However, groups did not differ in avoidance or distress during the test phases.
LIMITATIONS


US-expectancy ratings were collected only at the end of the experiment.
CONCLUSIONS


The results indicate that positive imagery during ExRP may be effective in reducing distress during the intervention. Explanations for the persistence of avoidance and fear are discussed.",2020,"However, groups did not differ in avoidance or distress during the test phases.
",[],['Counterconditioning (that was asked to imagine a positive sound during ExRP) or No Counterconditioning group (standard ExRP'],"['avoidance or distress', 'distress']",[],"[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}]",,0.037803,"However, groups did not differ in avoidance or distress during the test phases.
","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Hendrikx', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}, {'ForeName': 'Angelos-Miltiadis', 'Initials': 'AM', 'LastName': 'Krypotos', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands; Department of Healthy Psychology, KU Leuven, Belgium. Electronic address: amkrypotos@gmail.com.'}, {'ForeName': 'Iris M', 'Initials': 'IM', 'LastName': 'Engelhard', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101601']
1443,32836063,"Efficacy of scalp nerve blocks using ropivacaïne 0,75% associated with intravenous dexamethasone for postoperative pain relief in craniotomies.","Pain after supratentorial craniotomy is common, 55 % to 80 % of patients experience moderate to severe pain in the first 48 h(1-7). The importance of intravenous dexamethasone as an adjuvant to local anaesthetics is increasingly applied(1-7), however its role in scalp nerve blocks with ropivacaine 0.75 % remains unexplored in post-operative analgesia. We analyzed 134 supratentorial craniotomies under general anaesthesia, 46 of which had preoperatively bilateral scalp nerve blocks with ropivacaine 0.75 %. The general anaesthesia was standardized and included 8 mg of intravenous dexamethasone at the induction. The postoperative pain was assessed using the numerical rating scale with patients in the post anaesthesia care unit and subsequently every 8 h in the neurosurgery unit until the 48th hour. A NRS value above 3 led to the administration of a rescue analgesic according to the defined protocol until an efficient analgesia was obtained. Postoperative pain was controlled in both groups, however the need for rescue analgesics in the scalp nerve blocks group was reduced by 40 % (39 % vs. 65 %; p = 0.006) compared to the control group. More than 60 % of the patients from the scalp nerve blocks group had an efficient analgesia without any rescue analgesic. Peroperatively the scalp nerve blocks group showed a decrease in opioid consumption and a better hemodynamic stability. No anesthetic or chirurgical complications related to the use of scalp blocks were observed. Scalp nerve blocks associated with intravenous dexamethasone are found to be a straightforward and efficient analgesic approach during supratentorial craniotomies.",2020,"Postoperative pain was controlled in both groups, however the need for rescue analgesics in the scalp nerve blocks group was reduced by 40 % (39 % vs. 65 %; p = 0.006) compared to the control group.","['134 supratentorial craniotomies under general anaesthesia, 46 of which had preoperatively bilateral scalp nerve blocks with', 'craniotomies']","['dexamethasone', 'ropivacaïne', 'ropivacaine']","['efficient analgesia without any rescue analgesic', 'postoperative pain relief', 'severe pain', 'hemodynamic stability', 'Postoperative pain', 'Pain', 'opioid consumption', 'postoperative pain']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0442799', 'cui_str': 'Efficient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",134.0,0.065171,"Postoperative pain was controlled in both groups, however the need for rescue analgesics in the scalp nerve blocks group was reduced by 40 % (39 % vs. 65 %; p = 0.006) compared to the control group.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gaudray', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: eliott.gaudray@gmail.com.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': ""N' Guyen"", 'Affiliation': 'Department of Anesthesiology, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: cedric1.nguyen@intradef.gouv.fr.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Martin', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: edouard1.martin@intradef.gouv.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lyochon', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: arthur.lyochon@intradef.gouv.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dagain', 'Affiliation': 'Department of Neurosurgery, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: arnaud.dagain@intradef.gouv.fr.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bordes', 'Affiliation': 'Department of Anesthesiology, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: julien.bordes@intradef.gouv.fr.'}, {'ForeName': 'P Y', 'Initials': 'PY', 'LastName': 'Cordier', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: pierre-yves.cordier@intradef.gouv.fr.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Lacroix', 'Affiliation': 'Department of Anesthesiology, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: guillaume.lacroix@intradef.gouv.fr.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106125']
1444,32841683,"Oral administration of porcine liver decomposition product for 4 weeks enhances visual memory and delayed recall in healthy adults over 40 years of age: A randomized, double-blind, placebo-controlled study.","BACKGROUND AND OBJECTIVES


Porcine liver decomposition product (PLDP) contains neurofunctional phospholipids. We previously reported that PLDP enhances cognitive function in healthy adult humans, based on clinical evaluations using Hasegawa's Dementia Scale-Revised. In this study, we evaluated the effect of PLDP on memory indicators of the Wechsler Memory Scale-Revised (WMS-R), an internationally recognized battery for memory assessment.
METHODS


We conducted a double-blind parallel-group placebo-controlled trial to evaluate the effect of PLDP on memory. Fifty-eight participants competed the trial: 28 participants were in the PLDP group and 30 participants were in the placebo group. Each group was administered PLDP (4 capsules) or a placebo (4 capsules) for 4 continuous weeks. WMS-R was administered before and 4 weeks after PLDP or placebo intake. The data were also subdivided by age for participants under 40 years (N = 15 in PLDP; N = 15 in placebo) and over 40 years (N = 13 in PLDP, N = 15 in placebo). Changes in Verbal Memory, Visual Memory, Attention/Concentration, and Delayed Recall were analyzed.
RESULTS


No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age. However, for participants over 40 years of age, PLDP administration resulted in a significant enhancement than placebo administration in Delayed Recall (14.1 ± 7.1 points vs. 7.1 ± 6.8 points) (P < 0.05), Visual Recall I (20.1 ± 23.1 percentile vs 1.9 ± 22.8 percentile) (P < 0.05), and Visual Recall II (24.2 ± 25.8 percentile vs 6.7 ± 19.0 percentile) (P < 0.05), respectively. The composition ratio of men to women in each group was imbalanced but no significant difference existed between the two groups.
LIMITATIONS


A modest sample size, single-center design, and a fairly short follow-up period.
CONCLUSION


PLDP enhanced Visual Memory and Delayed Recall in healthy adults over 40 years of age but not in healthy adults under 40 years of age. Therefore, PLDP may represent a promising nutraceutical that could improve cognitive function in healthy adults over 40 years of age. Further studies are required to evaluate if long term PLDP administration can prevent or delay cognitive dysfunction in healthy adults over 40 years of age.",2020,No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age.,"['Fifty-eight participants competed the trial: 28 participants were in the PLDP group and 30 participants were in the', 'healthy adults over 40\u202fyears of age', 'healthy adult humans', 'participants under 40\u202fyears (N\u202f=\u202f15 in PLDP; N\u202f=\u202f15 in placebo) and over 40\u202fyears (N\u202f=\u202f13 in PLDP, N\u202f=\u202f15 in', 'healthy adults over 40\u202fyears of age but not in healthy adults under 40\u202fyears of age']","['PLDP', 'placebo', 'porcine liver decomposition product']","['Verbal Memory, Visual Memory, Attention/Concentration, and Delayed Recall', 'Visual Recall I', 'Visual Memory and Delayed Recall', 'cognitive function', 'memory indicators of the Wechsler Memory Scale-Revised (WMS-R', 'visual memory and delayed recall', 'composition ratio', 'Visual Recall', 'memory indicators', 'Delayed Recall']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",28.0,0.574256,No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age.,"[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan. Electronic address: yomatsuda@nichiyaku.ac.jp.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Haniu', 'Affiliation': 'Institute for Biomedical Sciences, Interdisciplinary Cluster for Cutting Edge Research, Shinshu University, Matsumoto 390-8621, Japan.'}, {'ForeName': 'Tamotsu', 'Initials': 'T', 'LastName': 'Tsukahara', 'Affiliation': 'Department of Pharmacology and Therapeutic Innovation, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8521, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Uemura', 'Affiliation': 'Institute for Biomedical Sciences, Interdisciplinary Cluster for Cutting Edge Research, Shinshu University, Matsumoto 390-8621, Japan; Division of Gene Research, Research Center for Supports to Advanced Science, Shinshu University, Matsumoto 390-8621, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Sako', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kojima', 'Affiliation': 'Medical and Health Resources Research Institute, Tokyo 170-0013, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Mori', 'Affiliation': 'Mori Neurosurgery Clinic, Tokyo 142-0053, Japan.'}, {'ForeName': 'Kazusaburou', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Sugar Lady Cosmetics Co., Ltd, Tokyo 107-6011, Japan.'}]",Experimental gerontology,['10.1016/j.exger.2020.111064']
1445,32843374,Changes in Blood Pressure and Arterial Hemodynamics following Living Kidney Donation.,"BACKGROUND AND OBJECTIVES


The Effect of a Reduction in GFR after Nephrectomy on Arterial Stiffness and Central Hemodynamics (EARNEST) study was a multicenter, prospective, controlled study designed to investigate the associations of an isolated reduction in kidney function on BP and arterial hemodynamics.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


Prospective living kidney donors and healthy controls who fulfilled criteria for donation were recruited from centers with expertise in vascular research. Participants underwent office and ambulatory BP measurement, assessment of arterial stiffness, and biochemical tests at baseline and 12 months.
RESULTS


A total of 469 participants were recruited, and 306 (168 donors and 138 controls) were followed up at 12 months. In the donor group, mean eGFR was 27 ml/min per 1.73 m 2  lower than baseline at 12 months. Compared with baseline, at 12 months the mean within-group difference in ambulatory day systolic BP in donors was 0.1 mm Hg (95% confidence interval, -1.7 to 1.9) and 0.6 mm Hg (95% confidence interval, -0.7 to 2.0) in controls. The between-group difference was -0.5 mm Hg (95% confidence interval, -2.8 to 1.7;  P =0.62). The mean within-group difference in pulse wave velocity in donors was 0.3 m/s (95% confidence interval, 0.1 to 0.4) and 0.2 m/s (95% confidence interval, -0.0 to 0.4) in controls. The between-group difference was 0.1 m/s (95% confidence interval, -0.2 to 0.3;  P =0.49).
CONCLUSIONS


Changes in ambulatory peripheral BP and pulse wave velocity in kidney donors at 12 months after nephrectomy were small and not different from controls.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


NCT01769924 (https://clinicaltrials.gov/ct2/show/NCT01769924).",2020,"The mean within-group difference in pulse wave velocity in donors was 0.3 m/s (95% confidence interval, 0.1 to 0.4) and 0.2 m/s (95% confidence interval, -0.0 to 0.4) in controls.","['Prospective living kidney donors and healthy controls who fulfilled criteria for donation were recruited from centers with expertise in vascular research', 'A total of 469 participants were recruited, and 306 (168 donors and 138 controls', 'Living Kidney Donation']",[],"['ambulatory peripheral BP and pulse wave velocity', 'Blood Pressure and Arterial Hemodynamics', 'ambulatory day systolic BP', 'mean eGFR', 'pulse wave velocity']","[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0260788', 'cui_str': 'Donor of kidney for transplant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0411257', 'cui_str': 'Donor nephrectomy'}]",[],"[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]",469.0,0.332628,"The mean within-group difference in pulse wave velocity in donors was 0.3 m/s (95% confidence interval, 0.1 to 0.4) and 0.2 m/s (95% confidence interval, -0.0 to 0.4) in controls.","[{'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Price', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom annaprice@doctors.org.uk.'}, {'ForeName': 'George H B', 'Initials': 'GHB', 'LastName': 'Greenhall', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Moody', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Steeds', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Patrick B', 'Initials': 'PB', 'LastName': 'Mark', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Edwards', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Manvir K', 'Initials': 'MK', 'LastName': 'Hayer', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Pickup', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Radhakrishnan', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Law', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Debasish', 'Initials': 'D', 'LastName': 'Banerjee', 'Affiliation': ""Renal and Transplantation Unit, St George's University Hospitals National Health Service Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Campbell', 'Affiliation': 'Manchester Royal Infirmary, Manchester, United Kingdom.'}, {'ForeName': 'Charles R V', 'Initials': 'CRV', 'LastName': 'Tomson', 'Affiliation': 'Southmead Hospital, Bristol, United Kingdom.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Cockcroft', 'Affiliation': 'Department of Cardiology, Wales Heart Research Institute, University Hospital, Cardiff, United Kingdom.'}, {'ForeName': 'Badri', 'Initials': 'B', 'LastName': 'Shrestha', 'Affiliation': 'Sheffield Kidney Institute, Sheffield Teaching Hospitals National Health Service Foundation Trust, Sheffield, United Kingdom.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Wilkinson', 'Affiliation': ""Cambridge Clinical Trials Unit, Clinical School, Addenbrooke's Hospital, University of Cambridge, Cambridge, United Kingdom.""}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Tomlinson', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ferro', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Jonathan N', 'Initials': 'JN', 'LastName': 'Townend', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.15651219']
1446,32846929,A Traditional Korean Diet Alters the Expression of Circulating MicroRNAs Linked to Diabetes Mellitus in a Pilot Trial.,"The traditional Korean diet (K-diet) is considered to be healthy and circulating microRNAs (miRs) have been proposed as useful markers or targets in diet therapy. We, therefore, investigated the metabolic influence of the K-diet by evaluating the expression of plasma and salivary miRs. Ten women aged 50 to 60 years were divided into either a K-diet or control diet (a Westernized Korean diet) group. Subjects were housed in a metabolic unit-like condition during the two-week dietary intervention. Blood and saliva samples were collected before and after the intervention, and changes in circulating miRs were screened by an miR array and validated by individual RT-qPCRs. In the K-diet group, eight plasma miRs were down-regulated by array ( p  < 0.05), out of which two miRs linked to diabetes mellitus, hsa-miR26a-5p and hsa-miR126-3p, were validated ( p  < 0.05). Among five down-regulated salivary miRs, hsa-miR-92-3p and hsa-miR-122a-5p were validated, which are associated with diabetes mellitus, acute coronary syndrome and non-alcoholic fatty liver disease. In the control diet group, validated were down-regulated plasma hsa-miR-25-3p and salivary hsa-miR-31-5p, which are associated with diabetes mellitus, adipogenesis and obesity. The K-diet may influence the metabolic conditions associated with diabetes mellitus, as evidenced by changes in circulating miRs, putative biomarkers for K-diet.",2020,"In the K-diet group, eight plasma miRs were down-regulated by array ( p  < 0.05), out of which two miRs linked to diabetes mellitus, hsa-miR26a-5p and hsa-miR126-3p, were validated ( p  < 0.05).",['Ten women aged 50 to 60 years'],"['K-diet or control diet (a Westernized Korean diet', 'traditional Korean diet (K-diet']","['Blood and saliva samples', 'eight plasma miRs', 'Expression of Circulating MicroRNAs']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C4055233', 'cui_str': 'Cell-Free MicroRNA'}]",10.0,0.0120408,"In the K-diet group, eight plasma miRs were down-regulated by array ( p  < 0.05), out of which two miRs linked to diabetes mellitus, hsa-miR26a-5p and hsa-miR126-3p, were validated ( p  < 0.05).","[{'ForeName': 'Phil-Kyung', 'Initials': 'PK', 'LastName': 'Shin', 'Affiliation': 'CHA Bio Complex, CHA University, Seongnam 13488, Korea.'}, {'ForeName': 'Myung Sunny', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Seon-Joo', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Seongnam 13120, Korea.'}, {'ForeName': 'Dae Young', 'Initials': 'DY', 'LastName': 'Kwon', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Min Jung', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Hye Jeong', 'Initials': 'HJ', 'LastName': 'Yang', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Soon-Hee', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'KyongChol', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Healthy Aging, GangNam Major Hospital, Seoul 06279, Korea.'}, {'ForeName': 'Sukyung', 'Initials': 'S', 'LastName': 'Chun', 'Affiliation': 'CHA Bio Complex, CHA University, Seongnam 13488, Korea.'}, {'ForeName': 'Hae-Jeung', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Seongnam 13120, Korea.'}, {'ForeName': 'Sang-Woon', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'CHA Bio Complex, CHA University, Seongnam 13488, Korea.'}]",Nutrients,['10.3390/nu12092558']
1447,32853647,Effect of long-term testosterone therapy on molecular regulators of skeletal muscle mass and fibre-type distribution in aging men with subnormal testosterone.,"BACKGROUND


Long-term testosterone replacement therapy (TRT) increases muscle mass in elderly men with subnormal testosterone levels. However, the molecular mechanisms underlying this effect of TRT on protein balance in human skeletal muscle in vivo remain to be established.
METHODS


Here, we examined skeletal muscle biopsies obtained before and 24-h after the last dose of treatment with either testosterone gel (n = 12) or placebo (n = 13) for 6 months in aging men with subnormal bioavailable testosterone levels. The placebo-controlled, testosterone-induced changes (β-coefficients) in mRNA levels, protein expression and phosphorylation were examined by quantitative real-time PCR and western blotting.
RESULTS


Long-term TRT increased muscle mass by β = 1.6 kg (p = 0.01) but had no significant effect on mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors. However, TRT caused a sustained decrease in protein expression of SMAD2 (β = -36%, p = 0.004) and SMAD3 (β = -32%, p = 0.001), which was accompanied by reduced protein expression of the muscle-specific E3-ubiquitin ligases, MuRF1 (β = -26%, p = 0.004) and Atrogin-1/MAFbx (β = -20%, p = 0.04), but with no changes in FOXO3 signalling. Importantly, TRT did not affect muscle fibre type distribution between slow-oxidative (type 1), fast-oxidative (type 2a) and fast-glycolytic (type 2×) muscle fibres.
CONCLUSIONS


Our results indicate that long-term TRT of elderly men with subnormal testosterone levels increases muscle mass, at least in part, by decreasing protein breakdown through the ubiquitin proteasome pathway mediated by a sustained suppression of SMAD-signalling and muscle-specific E3-ubiquitin ligases.",2020,"RESULTS


Long-term TRT increased muscle mass by β = 1.6 kg (p = 0.01) but had no significant effect on mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors.","['aging men with subnormal testosterone', 'elderly men with subnormal testosterone levels']","['testosterone replacement therapy (TRT', 'long-term testosterone therapy', 'placebo', 'testosterone gel', 'TRT']","['muscle fibre type distribution between slow-oxidative (type 1), fast-oxidative (type 2a) and fast-glycolytic (type 2×) muscle fibres', 'protein expression of SMAD2', 'Atrogin-1/MAFbx', 'muscle mass', 'skeletal muscle mass and fibre-type distribution', 'protein expression of the muscle-specific E3-ubiquitin ligases, MuRF1', 'mRNA levels, protein expression and phosphorylation', 'mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}]","[{'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1566790', 'cui_str': 'SMAD2 protein, human'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0041538', 'cui_str': 'Ubiquitin'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0050668', 'cui_str': 'Activin hormone'}, {'cui': 'C0076925', 'cui_str': 'USF Transcription Factors'}]",,0.0809258,"RESULTS


Long-term TRT increased muscle mass by β = 1.6 kg (p = 0.01) but had no significant effect on mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors.","[{'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Kruse', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Stine J', 'Initials': 'SJ', 'LastName': 'Petersson', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Louise L', 'Initials': 'LL', 'LastName': 'Christensen', 'Affiliation': 'Department of Endocrinology, Odense University Hospital, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Jonas M', 'Initials': 'JM', 'LastName': 'Kristensen', 'Affiliation': 'Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark; Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen, DK-2100 Copenhagen, Denmark.'}, {'ForeName': 'Rugivan', 'Initials': 'R', 'LastName': 'Sabaratnam', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Ørtenblad', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Muscle Research Cluster (SMRC), University of Southern Denmark, DK-5230 Odense, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Andersen', 'Affiliation': 'Department of Endocrinology, Odense University Hospital, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Højlund', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark. Electronic address: kurt.hoejlund@rsyd.dk.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154347']
1448,32854375,Optimisation and Validation of a Nutritional Intervention to Enhance Sleep Quality and Quantity.,"BACKGROUND


Disturbed sleep may negatively influence physical health, cognitive performance, metabolism, and general wellbeing. Nutritional interventions represent a potential non-pharmacological means to increase sleep quality and quantity.
OBJECTIVE


(1) Identify an optimal suite of nutritional ingredients and (2) validate the effects of this suite utilising polysomnography, and cognitive and balance tests.
METHODS


The optimal and least optimal combinations of six ingredients were identified utilising 55 male participants and a Box-Behnken predictive model. To validate the model, 18 healthy, male, normal sleepers underwent three trials in a randomised, counterbalanced design: (1) optimal drink, (2) least optimal drink, or (3) placebo were provided before bed in a double-blinded manner. Polysomnography was utilised to measure sleep architecture. Cognitive performance, postural sway, and subjective sleep quality, were assessed 30 min after waking.
RESULTS


The optimal drink resulted in a significantly shorter sleep onset latency (9.9 ± 12.3 min) when compared to both the least optimal drink (26.1 ± 37.4 min) and the placebo drink (19.6 ± 32.0 min). No other measures of sleep, cognitive performance, postural sway, and subjective sleep quality were different between trials.
CONCLUSION


A combination of ingredients, optimised to enhance sleep, significantly reduced sleep onset latency. No detrimental effects on sleep architecture, subjective sleep quality or next day performance were observed.",2020,The optimal drink resulted in a significantly shorter sleep onset latency (9.9 ± 12.3 min) when compared to both the least optimal drink (26.1 ± 37.4 min) and the placebo drink (19.6 ± 32.0 min).,"['18 healthy, male, normal sleepers', '55 male participants and a Box-Behnken predictive model']","['optimal drink, (2) least optimal drink, or (3) placebo', 'placebo', 'Nutritional Intervention']","['shorter sleep onset latency', 'Sleep Quality and Quantity', 'sleep quality and quantity', 'sleep onset latency', 'Cognitive performance, postural sway, and subjective sleep quality', 'sleep, cognitive performance, postural sway, and subjective sleep quality', 'sleep architecture, subjective sleep quality or next day performance']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",55.0,0.0736757,The optimal drink resulted in a significantly shorter sleep onset latency (9.9 ± 12.3 min) when compared to both the least optimal drink (26.1 ± 37.4 min) and the placebo drink (19.6 ± 32.0 min).,"[{'ForeName': 'Shona L', 'Initials': 'SL', 'LastName': 'Halson', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Banyo QLD 4014, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Shaw', 'Affiliation': 'High Performance Unit, Swimming Australia, Brisbane QLD 4519, Australia.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Versey', 'Affiliation': 'Rowing Australia, Yarralumla ACT 2600, Australia.'}, {'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Miller', 'Affiliation': 'Appleton Institute for Behavioural Science, Central Queensland University, Wayville 5034, Australia.'}, {'ForeName': 'Charli', 'Initials': 'C', 'LastName': 'Sargent', 'Affiliation': 'Appleton Institute for Behavioural Science, Central Queensland University, Wayville 5034, Australia.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Roach', 'Affiliation': 'Appleton Institute for Behavioural Science, Central Queensland University, Wayville 5034, Australia.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Nyman', 'Affiliation': 'Gatorade Sport Science Institute, PepsiCo Global Research and Development-Life Sciences, Purchase, NY 10577, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Carter', 'Affiliation': 'Gatorade Sport Science Institute, PepsiCo Global Research and Development-Life Sciences, Purchase, NY 10577, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Baar', 'Affiliation': 'Departments of Neurobiology, Physiology & Behavior and Department of Physiology and Membrane Biology, University of California Davis School of Medicine, Davis, CA 95817, USA.'}]",Nutrients,['10.3390/nu12092579']
1449,32867406,Training in statistical analysis reduces the framing effect on medical students and residents in Argentina.,"PURPOSE


The framing effect refers to a phenomenon whereby, when the same problem is presented using different representations of information, people make significant changes in their decisions.Itaimed to explore whether theframingeffect could be reduced in medical students and residents by teaching them the statistical concepts of effect size, probability, and sampling to be used in the medical decision-making process.
Methods


Ninety-five second-year medical students and 100 second-year medical residentsof Austral University and Buenos Aires University, Argentina were invited to participate in the study between March and June 2017. A questionnaire was developed to assess the different types of framing effects in medical situations. After an initial administration of the survey, students and residents were taught statistical concepts including effect size, probability, and sampling during two individual independent official biostatistics courses. After these interventions, the same questionnaire was randomly applied again, and pre- and post-intervention outcomes were compared for students and residents.
RESULTS


Almost every type of framing effect was reproduced either in the students or in the resident population. After teaching medical students and residents the analytical process behind statistical notions, a significant reduction in sample-size, risky-choice, pseudo-certainty, number-size, attribute, goal, and probabilistic formulation framing effects was observed.
Conclusion


s Decision-making of medical students and residents in simulated medical situations may be affected by different frame descriptions, and these framing effects can be partially reduced by training individuals in probability analysis and statistical sampling methods.",2020,Almost every type of framing effect was reproduced either in the students or in the resident population.,"['Austral University and Buenos Aires University, Argentina were invited to participate in the study between March and June 2017', 'Methods\n\n\nNinety-five second-year medical students and 100 second-year medical residentsof']",[],[],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1741275', 'cui_str': 'AIRE protein, human'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]",[],[],,0.0258185,Almost every type of framing effect was reproduced either in the students or in the resident population.,"[{'ForeName': 'Raúl A', 'Initials': 'RA', 'LastName': 'Borracci', 'Affiliation': 'Biostatistics, School of Medicine, Austral University, Buenos Aires, Argentina.'}, {'ForeName': 'Eduardo B', 'Initials': 'EB', 'LastName': 'Arribalzaga', 'Affiliation': 'Biostatistics, School of Medicine, Austral University, Buenos Aires, Argentina.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Thierer', 'Affiliation': 'School of Medicine, Buenos Aires University, Buenos Aires, Argentina.'}]",Journal of educational evaluation for health professions,['10.3352/jeehp.2020.17.25']
1450,32841300,"An age-adapted plyometric exercise program improves dynamic strength, jump performance and functional capacity in older men either similarly or more than traditional resistance training.","Power declines at a greater rate during ageing and is more relevant for functional deterioration than either loss of maximum strength or muscle mass. Human movement typically consists of stretch-shortening cycle action. Therefore, plyometric exercises, using an eccentric phase quickly followed by a concentric phase to optimize power production, should resemble daily function more than traditional resistance training, which primarily builds force production capacity in general. However, it is unclear whether older adults can sustain such high-impact training. This study compared the effects of plyometric exercise (PLYO) on power, force production, jump and functional performance to traditional resistance training (RT) and walking (WALK) in older men. Importantly, feasibility was investigated. Forty men (69.5 ± 3.9 years) were randomized to 12-weeks of PLYO (N = 14), RT (N = 12) or WALK (N = 14). Leg press one-repetition maximum (1-RM), leg-extensor isometric maximum voluntary contraction (MVC) and rate of force development (RFD), jump and functional performance were evaluated pre- and post-intervention. One subject in RT (low back pain) and three in PLYO (2 muscle strains, 1 knee pain) dropped out. Adherence to (91.2 ± 4.4%) and acceptability of (≥ 7/10) PLYO was high. 1-RM improved more in RT (25.0 ± 10.0%) and PLYO (23.0 ± 13.6%) than in WALK (2.9 ± 13.7%) (p < 0.001). PLYO improved more on jump height, jump power, contraction time of jumps and stair climbing performance compared to WALK and/or RT (p < 0.05). MVC improved in RT only (p = 0.028) and RFD did not improve (p > 0.05). To conclude, PLYO is beneficial over RT for improving power, jump and stair climbing performance without compromising gains in strength. This form of training seems feasible, but contains an inherent higher risk for injuries, which should be taken into account when designing programs for older adults.",2020,"PLYO improved more on jump height, jump power, contraction time of jumps and stair climbing performance compared to WALK","['older adults', 'Forty men (69.5 ± 3.9 years', 'older men', 'older men either similarly or more than traditional resistance training']","['PLYO', 'plyometric exercise program', 'plyometric exercises', 'WALK', 'traditional resistance training (RT) and walking (WALK', 'plyometric exercise (PLYO']","['dynamic strength, jump performance and functional capacity', 'RFD', 'power, force production, jump and functional performance', 'jump height, jump power, contraction time of jumps and stair climbing performance', 'Leg press one-repetition maximum (1-RM), leg-extensor isometric maximum voluntary contraction (MVC) and rate of force development (RFD), jump and functional performance', 'MVC improved in RT', '1-RM improved more in RT']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]",40.0,0.0188582,"PLYO improved more on jump height, jump power, contraction time of jumps and stair climbing performance compared to WALK","[{'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Van Roie', 'Affiliation': 'Physical Activity, Sports and Health Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Neuromuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Van Driessche', 'Affiliation': 'Physical Activity, Sports and Health Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Tijs', 'Initials': 'T', 'LastName': 'Delabastita', 'Affiliation': 'Human Movement Biomechanics Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Benedicte', 'Initials': 'B', 'LastName': 'Vanwanseele', 'Affiliation': 'Human Movement Biomechanics Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Delecluse', 'Affiliation': 'Physical Activity, Sports and Health Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}]",PloS one,['10.1371/journal.pone.0237921']
1451,32841904,Hyperarousal symptoms and perceived burdensomeness interact to predict suicidal ideation among trauma-exposed individuals.,"The association between posttraumatic stress disorder (PTSD) and suicidal ideation is well-established and recent prospective studies have demonstrated the unique role of hyperarousal symptoms. In particular, over-arousal may elevate suicide risk in the presence of interpersonal vulnerability factors including thwarted belongingness, perceived burdensomeness, and acquired capability. Therefore, the current study sought to examine the differential associations between PTSD symptom clusters and suicidality and the impact of interpersonal risk factors. Trauma-exposed adults (N = 247) completed a questionnaire battery at baseline and three-month follow-up, as part of a larger randomized controlled trial of computerized interventions for suicide risk. Given the focus of the current study, treatment condition was controlled for in all analyses. Results indicated that hyperarousal symptoms significantly predict suicidality, while reexperiencing and avoidance symptoms do not. Specifically, greater hyperarousal symptoms predicted increased suicidal ideation among individuals with high perceived burdensomeness. Although the interaction effect was not significant, hyperarousal symptoms were also pertinent among individuals with high acquired capability. Taken together, findings suggest that assessment of hyperarousal symptoms and perceived burdensomeness may serve to identify trauma-exposed individuals at greater risk for suicide. Additionally, these factors may serve as effective intervention targets.",2020,"Although the interaction effect was not significant, hyperarousal symptoms were also pertinent among individuals with high acquired capability.",['Trauma-exposed adults (N\xa0=\xa0247) completed a'],['questionnaire battery at baseline and three-month follow-up'],"['hyperarousal symptoms', 'suicidal ideation', 'Hyperarousal symptoms']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]",247.0,0.0289762,"Although the interaction effect was not significant, hyperarousal symptoms were also pertinent among individuals with high acquired capability.","[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Morabito', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA. Electronic address: Morabito@psy.fsu.edu.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Boffa', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA.'}, {'ForeName': 'Carter E', 'Initials': 'CE', 'LastName': 'Bedford', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA.'}, {'ForeName': 'Jimmy P', 'Initials': 'JP', 'LastName': 'Chen', 'Affiliation': 'Furman University, 3300 Poinsett Hwy, Greenville, SC, USA, 29613.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.029']
1452,32846971,Effect of an EMG-FES Interface on Ankle Joint Training Combined with Real-Time Feedback on Balance and Gait in Patients with Stroke Hemiparesis.,"This study evaluated the effects of an electromyography-functional electrical stimulation interface (EMG-FES interface) combined with real-time balance and gait feedback on ankle joint training in patients with stroke hemiplegia. Twenty-six stroke patients participated in this study. All subjects were randomly assigned to either the EMG-FES interface combined with real-time feedback on ankle joint training (RFEF) group ( n  = 13) or the EMG-FES interface on ankle joint training (EF) group ( n  = 13). Subjects in both groups were trained for 20 min a day, 5 times a week, for 4 weeks. Similarly, all participants underwent a standard rehabilitation physical therapy for 60 min a day, 5 times a week, for 4 weeks. The RFEF group showed significant increases in weight-bearing lunge test (WBLT), Tardieu Scale (TS), Timed Up and Go Test (TUG), Berg Balance Scale (BBS), velocity, cadence, step length, stride length, stance per, and swing per ( p <  0.05). Likewise, the EF group showed significant increases in WBLT, TUG, BBS, velocity, and cadence ( p  < 0.05). Moreover, the RFEF group showed significantly greater improvements than the EF group in terms of WBLT, Tardieu Scale, TUG, BBS, velocity, step length, stride length, stance per, and swing per ( p  < 0.05). Ankle joint training using an EMG-FES interface combined with real-time feedback improved ankle range of motion (ROM), muscle tone, balance, and gait in stroke patients. These results suggest that an EMG-FES interface combined with real-time feedback is feasible and suitable for ankle joint training in individuals with stroke.",2020,"Moreover, the RFEF group showed significantly greater improvements than the EF group in terms of WBLT, Tardieu Scale, TUG, BBS, velocity, step length, stride length, stance per, and swing per ( p  < 0.05).","['Patients with Stroke Hemiparesis', 'individuals with stroke', 'Twenty-six stroke patients participated in this study', 'stroke patients', 'patients with stroke hemiplegia']","['RFEF', 'electromyography-functional electrical stimulation interface (EMG-FES interface) combined with real-time balance and gait feedback', 'Combined with Real-Time Feedback', 'standard rehabilitation physical therapy', 'EMG-FES interface combined with real-time feedback', 'EMG-FES Interface', 'EMG-FES interface combined with real-time feedback on ankle joint training (RFEF) group ( n  = 13) or the EMG-FES interface on ankle joint training (EF', 'Ankle joint training using an EMG-FES interface combined with real-time feedback']","['Ankle Joint Training', 'WBLT, TUG, BBS, velocity, and cadence', 'WBLT, Tardieu Scale, TUG, BBS, velocity, step length, stride length, stance per, and swing per', 'Balance and Gait', 'ankle range of motion (ROM), muscle tone, balance, and gait', 'weight-bearing lunge test (WBLT), Tardieu Scale (TS), Timed Up and Go Test (TUG), Berg Balance Scale (BBS), velocity, cadence, step length, stride length, stance per, and swing per']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0525959', 'cui_str': '16-fluoroestradiol, (16alpha, 17beta)-isomer, (18F)-labeled'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}]",,0.0156884,"Moreover, the RFEF group showed significantly greater improvements than the EF group in terms of WBLT, Tardieu Scale, TUG, BBS, velocity, step length, stride length, stance per, and swing per ( p  < 0.05).","[{'ForeName': 'Subeen', 'Initials': 'S', 'LastName': 'Bae', 'Affiliation': 'Graduate School of Physical Therapy, Sahmyook University, Seoul 01795, Korea.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Graduate School of Physical Therapy, Sahmyook University, Seoul 01795, Korea.'}, {'ForeName': 'Byoung-Hee', 'Initials': 'BH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Sahmyook University, Seoul 01795, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8030292']
1453,32853281,Auricular stimulation vs. expressive writing for exam anxiety in medical students - A randomized crossover investigation.,"OBJECTIVE


Auricular stimulation (AS) is a promising method in the treatment of situational anxiety. Expressive writing (EW) is an established psychological method, which reduces test anxiety and improves exam results. The aim of this crossover trial was to compare AS with EW, and with the no intervention (NI) condition, for treatment of exam anxiety.
METHODS


Healthy medical students underwent 3 comparable anatomy exams with an interval of one month, either performing EW, receiving AS or NI prior to the exam; the order of interventions was randomized. AS was applied using indwelling fixed needles bilaterally at the areas innervated mostly by the auricular branch of the vagal nerve on the day before the exam. Anxiety level, measured using State-Trait-Anxiety Inventory (STAI) before and after the interventions and immediately before exam, was the primary outcome. Quality of night sleep, blood pressure, heart rate and activity of salivary alpha-amylase (sAA) were analyzed across 3 conditions.
RESULTS


All 37 included participants completed the study. Anxiety level (STAI) decreased immediately after AS in comparison with baseline (P = 0.02) and remained lower in comparison with that after EW and NI (P<0.01) on the day of exam. After EW and NI anxiety increased on the day of exam in comparison with baseline (P<0.01). Quality of sleep improved after AS in comparison with both control conditions (P<0.01). The activity of sAA decreased after EW and after AS (P<0.05) but not after NI condition.
CONCLUSION


Auricular stimulation, but not expressive writing, reduced exam anxiety and improved quality of sleep in medical students. These changes might be due to reduced activity of the sympathetic nervous system.",2020,Anxiety level (STAI) decreased immediately after AS in comparison with baseline (P = 0.02) and remained lower in comparison with that after EW and NI (P<0.01) on the day of exam.,"['All 37 included participants completed the study', 'Healthy medical students underwent 3 comparable anatomy exams with an interval of one month, either performing EW, receiving AS or NI prior to the exam; the order of interventions was randomized', 'medical students']","['Auricular stimulation vs. expressive writing', 'Auricular stimulation (AS', 'Expressive writing (EW']","['Quality of sleep', 'activity of sAA', 'Anxiety level, measured using State-Trait-Anxiety Inventory (STAI', 'Anxiety level (STAI', 'Quality of night sleep, blood pressure, heart rate and activity of salivary alpha-amylase (sAA', 'NI anxiety', 'expressive writing, reduced exam anxiety and improved quality of sleep']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}]",37.0,0.023505,Anxiety level (STAI) decreased immediately after AS in comparison with baseline (P = 0.02) and remained lower in comparison with that after EW and NI (P<0.01) on the day of exam.,"[{'ForeName': 'Taras', 'Initials': 'T', 'LastName': 'Usichenko', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wenzel', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Klausenitz', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Petersmann', 'Affiliation': 'Institute of Clinical Chemistry and Laboratory Medicine, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hesse', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Neumann', 'Affiliation': 'Institute of Diagnostic Radiology and Neuroradiology, Functional Imaging Unit, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hahnenkamp', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}]",PloS one,['10.1371/journal.pone.0238307']
1454,32853755,"Effect of Simulation-Based Training and Neurofeedback Interventions on Radiation Technologists' Workload, Situation Awareness, and Performance.","PURPOSE


Our purpose was to assess the effect of a combined intervention - simulation-based training supported by neurofeedback sessions - on radiation technologists' (RTs') workload, situation awareness, and performance during routine quality assurance and treatment delivery tasks.
METHODS AND MATERIALS


As part of a prospective institutional review board approved study, 32 RTs previously randomized to receive versus not receive simulation-based training focused on patient safety were again randomized to receive versus not receive a 3-week neurofeedback intervention (8 sessions of alpha-theta protocol) focused on stress reduction as well as conscious precision, strong focus, and ability to solve arising problems. Perceived workload was quantified using the NASA Task Load Index. Situation awareness was quantified using the situation awareness rating technique. Performance score was calculated using procedural compliance with time-out components and error detection.
RESULTS


RTs randomized to simulation-based training followed by neurofeedback sessions demonstrated no significant changes in perceived workload or situation awareness scores, but did have better performance compared with other study groups (P < .01).
CONCLUSIONS


This finding is encouraging and provides basis for using neurofeedback as means to possibly augment performance improvements gained during simulation-based training.",2020,"RESULTS


RTs randomized to simulation-based training followed by neurofeedback sessions demonstrated no significant changes in perceived workload or situation awareness scores, but did have better performance, when compared with other study groups (p < 0.01).
",[],"['neurofeedback intervention (8 sessions of alpha-theta protocol', 'Simulation-based Training and Neurofeedback Interventions', 'combined intervention - simulation-based training']","['Radiation Technologists Workload, Situation Awareness, and Performance', 'perceived workload or situation awareness scores', ""radiation technologists (RTs') workload, situation awareness, and performance during routine quality assurance (QA"", 'Performance score', 'situation awareness rating technique (SART']",[],"[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0260280', 'cui_str': 'Technologist'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",32.0,0.017154,"RESULTS


RTs randomized to simulation-based training followed by neurofeedback sessions demonstrated no significant changes in perceived workload or situation awareness scores, but did have better performance, when compared with other study groups (p < 0.01).
","[{'ForeName': 'Lukasz M', 'Initials': 'LM', 'LastName': 'Mazur', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; School of Information and Library Sciences, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Carolina Health Informatics Program, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. Electronic address: lmazur@med.unc.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Adams', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Prithima R', 'Initials': 'PR', 'LastName': 'Mosaly', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; School of Information and Library Sciences, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Carolina Health Informatics Program, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nuamah', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Adapa', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Carolina Health Informatics Program, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Lawrence B', 'Initials': 'LB', 'LastName': 'Marks', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}]",Practical radiation oncology,['10.1016/j.prro.2020.08.005']
1455,32856353,Stress management training program for stress reduction and coping improvement in public health nurses: A randomized controlled trial.,"AIMS


This study aimed to evaluate the effect of the stress management interventional program in reducing occupational stress and improving coping strategies among public health nurses.
DESIGN


A double-blind, cluster-randomized approach was used as a randomization method for this study to evaluate the stress management interventional program.
METHODS


A cluster-randomized controlled trial was carried out in eight comprehensive healthcare centres in Amman city, Jordan; four centres were randomly assigned to each experimental and control group. One hundred and seventy nurses were selected randomly from March 2019 - August 2019 and data were collected by using the Nursing Stress Scale & brief COPE over three data collection times. Both descriptive and inferential statistics (repeated measure ANOVA, Independent t test, and chi-squared) were used to answer the research questions of this study.
RESULTS


The results showed that both the levels of occupational stress and coping strategies were significantly different between the two study groups over the three data collection points (p < 0.05).
CONCLUSION


Based on the findings of this study, the stress management program is an effective non-invasive method that can be used to reduce stress levels and improve coping strategies for public health nurses. The implementation of stress management interventions in health care is likely to help nurses manage occupational stress in practice.
IMPACT


Nurses suffer from a high level of occupational stress. In particular, approximately74% of nurses experience severe occupational stress, which can lead to many mental and physical disorders. However, nurses were less able to utilize the correct stress preventive strategies due to gaps in knowledge, skills, and awareness. This study contributed to the provision of empirical evidence of the effectiveness of the stress management program in reducing occupational stress and improving coping strategies among public health nurses. A stress management intervention program is a valuable non-invasive method that can be used by healthcare organizations to reduce stress levels and improve coping strategies for nurses in practice.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03833986.",2020,"A stress management intervention program is a valuable non-invasive method that can be used by healthcare organizations to reduce stress levels and improve coping strategies for nurses in practice.
","['public health nurses', 'One hundred and seventy nurses', 'eight comprehensive healthcare centres in Amman city, Jordan; four centres']","['stress management interventional program', 'stress management program', 'Stress management training program']","['levels of occupational stress and coping strategies', 'occupational stress']","[{'cui': 'C0034022', 'cui_str': 'Public health nurse'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0009586', 'cui_str': 'Comprehensive Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}]","[{'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",8.0,0.0279992,"A stress management intervention program is a valuable non-invasive method that can be used by healthcare organizations to reduce stress levels and improve coping strategies for nurses in practice.
","[{'ForeName': ""Ja'far M"", 'Initials': 'JM', 'LastName': 'Alkhawaldeh', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department of Nursing and Rehabilitation, University Putra Malaysia (UPM), Selangor, Malaysia.'}, {'ForeName': 'Kim Lam', 'Initials': 'KL', 'LastName': 'Soh', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department of Nursing and Rehabilitation, University Putra Malaysia (UPM), Selangor, Malaysia.'}, {'ForeName': 'Firdaus', 'Initials': 'F', 'LastName': 'Mukhtar', 'Affiliation': 'Faculty of Medicines and Health Sciences, Department of Psychiatry, University Putra Malaysia (UPM), Selangor, Malaysia.'}, {'ForeName': 'Ooi Cheow', 'Initials': 'OC', 'LastName': 'Peng', 'Affiliation': 'Faculty of Medicines and Health Sciences, Department of Medicine, University Putra Malaysia (UPM), Selangor, Malaysia.'}, {'ForeName': 'Hamzeh M', 'Initials': 'HM', 'LastName': 'Alkhawaldeh', 'Affiliation': 'King Hussein Medical Center, Amman, Jordan.'}, {'ForeName': 'Rasmieh', 'Initials': 'R', 'LastName': 'Al-Amer', 'Affiliation': 'School of Nursing and Midwifery, Isra University/Western Sydney University, Amman, Jordan.'}, {'ForeName': 'Huda A', 'Initials': 'HA', 'LastName': 'Anshasi', 'Affiliation': 'School of Nursing, The University of Jordan, Amman, Jordan.'}]",Journal of advanced nursing,['10.1111/jan.14506']
1456,32857955,"Immediate impact of stay-at-home orders to control COVID-19 transmission on socioeconomic conditions, food insecurity, mental health, and intimate partner violence in Bangladeshi women and their families: an interrupted time series.","BACKGROUND


Stay-at-home orders (lockdowns) have been deployed globally to control COVID-19 transmission, and might impair economic conditions and mental health, and exacerbate risk of food insecurity and intimate partner violence. The effect of lockdowns in low-income and middle-income countries must be understood to ensure safe deployment of these interventions in less affluent settings. We aimed to determine the immediate impact of COVID-19 lockdown orders on women and their families in rural Bangladesh.
METHODS


An interrupted time series was used to compare data collected from families in Rupganj upazila, rural Bangladesh (randomly selected from participants in a randomised controlled trial), on income, food security, and mental health a median of 1 year and 2 years before the COVID-19 pandemic to data collected during the lockdown. We also assessed women's experiences of intimate partner violence during the pandemic.
RESULTS


Between May 19 and June 18, 2020, we randomly selected and invited the mothers of 3016 children to participate in the study, 2424 of whom provided consent. 2414 (99·9%, 95% CI 99·6-99·9) of 2417 mothers were aware of, and adhering to, the stay-at-home advice. 2321 (96·0%, 95·2-96·7) of 2417 mothers reported a reduction in paid work for the family. Median monthly family income fell from US$212 at baseline to $59 during lockdown, and the proportion of families earning less than $1·90 per day rose from five (0·2%, 0·0-0·5) of 2422 to 992 (47·3%, 45·2-49·5) of 2096 (p<0·0001 comparing baseline with lockdown period). Before the pandemic, 136 (5·6%, 4·7-6·6) of 2420 and 65 (2·7%, 2·1-3·4) of 2420 families experienced moderate and severe food insecurity, respectively. This increased to 881 (36·5%, 34·5-38·4) of 2417 and 371 (15·3%, 13·9-16·8) of 2417 during the lockdown; the number of families experiencing any level of food insecurity increased by 51·7% (48·1-55·4; p<0·0001). Mothers' depression and anxiety symptoms increased during the lockdown. Among women experiencing emotional or moderate physical violence, over half reported it had increased since the lockdown.
INTERPRETATION


COVID-19 lockdowns present significant economic, psychosocial, and physical risks to the wellbeing of women and their families across economic strata in rural Bangladesh. Beyond supporting only the most socioeconomically deprived, support is needed for all affected families.
FUNDING


National Health and Medical Research Council, Australia.",2020,"This increased to 881 (36·5%, 34·5-38·4) of 2417 and 371 (15·3%, 13·9-16·8) of 2417 during the lockdown; the number of families experiencing any level of food insecurity increased by 51·7% (48·1-55·4; p<0·0001).","['Bangladeshi women and their families', 'Between May 19 and June 18, 2020, we randomly selected and invited the mothers of 3016 children to participate in the study, 2424 of whom provided consent', ""women's experiences of intimate partner violence during the pandemic"", '2414', '2321', '2417 mothers', 'families in Rupganj upazila, rural Bangladesh (randomly selected from participants in a randomised controlled trial), on income, food security, and mental health a median of 1 year and 2 years before the COVID-19 pandemic to data collected during the lockdown', 'women and their families in rural Bangladesh', 'women experiencing emotional or moderate physical violence']",['lockdowns'],"['number of families experiencing any level of food insecurity', ""Mothers' depression and anxiety symptoms"", 'socioeconomic conditions, food insecurity, mental health, and intimate partner violence']","[{'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",3016.0,0.0664138,"This increased to 881 (36·5%, 34·5-38·4) of 2417 and 371 (15·3%, 13·9-16·8) of 2417 during the lockdown; the number of families experiencing any level of food insecurity increased by 51·7% (48·1-55·4; p<0·0001).","[{'ForeName': 'Jena Derakhshani', 'Initials': 'JD', 'LastName': 'Hamadani', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammed Imrul', 'Initials': 'MI', 'LastName': 'Hasan', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Baldi', 'Affiliation': 'Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, Australia; Department of Medical Biology, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Sheikh Jamal', 'Initials': 'SJ', 'LastName': 'Hossain', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Shamima', 'Initials': 'S', 'LastName': 'Shiraji', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad Saiful Alam', 'Initials': 'MSA', 'LastName': 'Bhuiyan', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Syeda Fardina', 'Initials': 'SF', 'LastName': 'Mehrin', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Fisher', 'Affiliation': 'Department of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Fahmida', 'Initials': 'F', 'LastName': 'Tofail', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'S M Mulk Uddin', 'Initials': 'SMMU', 'LastName': 'Tipu', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Grantham-McGregor', 'Affiliation': 'Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Beverley-Ann', 'Initials': 'BA', 'LastName': 'Biggs', 'Affiliation': 'Department of Medicine, Peter Doherty Institute, The University of Melbourne, Parkville, VIC, Australia; Victorian Infectious Diseases Service, Royal Melbourne Hospital, Parkville, VIC, Australia.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Braat', 'Affiliation': 'Department of Medicine, Peter Doherty Institute, The University of Melbourne, Parkville, VIC, Australia; School of Population and Global Health, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Sant-Rayn', 'Initials': 'SR', 'LastName': 'Pasricha', 'Affiliation': 'Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, Australia; Department of Medical Biology, The University of Melbourne, Parkville, VIC, Australia; Diagnostic Haematology, Royal Melbourne Hospital, Parkville, VIC, Australia; Clinical Haematology at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Parkville, VIC Australia. Electronic address: pasricha.s@wehi.edu.au.'}]",The Lancet. Global health,['10.1016/S2214-109X(20)30366-1']
1457,32858791,"Effectiveness of Health-Led Cognitive Behavioral-Based Group Therapy on Pain, Functional Disability and Psychological Outcomes among Knee Osteoarthritis Patients in Malaysia.","BACKGROUND


Psychosocial interventions for patients with osteoarthritis (OA) of the knee to reduce pain and improve physical and psychological functioning are still lacking in Malaysia.
METHODS


A parallel-group unblinded randomized controlled trial involving 300 patients was conducted in two hospital orthopedics clinics in Malaysia. Patients were randomly assigned to receive cognitive behavioral-based group therapy ( n  = 150) or no further intervention ( n  = 150). The primary outcome was the change from baseline in knee pain as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS) at 6 months. The data collected were analyzed by covariate-adjusted mixed design repeated measures analysis of variance. All analyses were performed under the terms of intention-to-treat.
RESULTS


At 6 months, mean change from baseline in the KOOS knee pain score was 0.6 points (95% CI -1.73 to 2.94) in the control group and 8.9 points (95% CI 6.62 to 11.23) (denoting less knee pain intensity) in the intervention group (significant treatment effect  p  < 0.0001). Patients treated with such an approach also experienced significant improvement in functional ability when performing activities of daily living and had improved ability to cope with depression, anxiety and pain catastrophizing.
CONCLUSION


The intervention module delivered by healthcare professionals had a sustained effect on knee OA pain and functionality over 6 months, thereby leading to an overall improvement in psychological well-being, thus benefitting most of the Malaysian knee OA patients.",2020,"Patients treated with such an approach also experienced significant improvement in functional ability when performing activities of daily living and had improved ability to cope with depression, anxiety and pain catastrophizing.
","['patients with osteoarthritis (OA', '300 patients was conducted in two hospital orthopedics clinics in Malaysia', 'Knee Osteoarthritis Patients in Malaysia']","['cognitive behavioral-based group therapy ( n  = 150) or no further intervention', 'Health-Led Cognitive Behavioral-Based Group Therapy']","['knee OA pain and functionality', 'ability to cope with depression, anxiety and pain catastrophizing', 'knee pain intensity', 'Pain, Functional Disability and Psychological Outcomes', 'change from baseline in knee pain as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS', 'functional ability', 'KOOS knee pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3838700', 'cui_str': 'Orthopedic clinic'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0424097', 'cui_str': 'Ability to cope'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",300.0,0.133232,"Patients treated with such an approach also experienced significant improvement in functional ability when performing activities of daily living and had improved ability to cope with depression, anxiety and pain catastrophizing.
","[{'ForeName': 'Chai Nien', 'Initials': 'CN', 'LastName': 'Foo', 'Affiliation': 'Department of Population Medicine, Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Kajang 43000, Malaysia.'}, {'ForeName': 'Manohar', 'Initials': 'M', 'LastName': 'Arumugam', 'Affiliation': 'Department of Orthopaedic, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Rampal', 'Initials': 'R', 'LastName': 'Lekhraj', 'Affiliation': 'Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Munn-Sann', 'Initials': 'MS', 'LastName': 'Lye', 'Affiliation': 'Department of Population Medicine, Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Kajang 43000, Malaysia.'}, {'ForeName': 'Sherina', 'Initials': 'S', 'LastName': 'Mohd-Sidik', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Zubaidah', 'Initials': 'Z', 'LastName': 'Jamil Osman', 'Affiliation': 'Faculty of Allied Health Sciences, Cyberjaya University College of Medical Sciences, Cyberjaya 63000, Malaysia.'}]",International journal of environmental research and public health,['10.3390/ijerph17176179']
1458,32858844,Interleukin-6 Gene Expression Changes after a 4-Week Intake of a Multispecies Probiotic in Major Depressive Disorder-Preliminary Results of the PROVIT Study.,"Major depressive disorder (MDD) is a prevalent disease, in which one third of sufferers do not respond to antidepressants. Probiotics have the potential to be well-tolerated and cost-efficient treatment options. However, the molecular pathways of their effects are not fully elucidated yet. Based on previous literature, we assume that probiotics can positively influence inflammatory mechanisms. We aimed at analyzing the effects of probiotics on gene expression of inflammation genes as part of the randomized, placebo-controlled, multispecies probiotics PROVIT study in Graz, Austria. Fasting blood of 61 inpatients with MDD was collected before and after four weeks of probiotic intake or placebo. We analyzed the effects on gene expression of tumor necrosis factor ( TNF ), nuclear factor kappa B subunit 1 ( NFKB1 ) and interleukin-6 ( IL-6 ). In  IL-6  we found no significant main effects for group ( F (1,44)  = 1.33,  p  = ns) nor time ( F (1,44)  = 0.00,  p  = ns), but interaction was significant ( F (1,44)  = 5.67,  p  < 0.05). The intervention group showed decreasing  IL-6  gene expression levels while the placebo group showed increasing gene expression levels of  IL-6 . Probiotics could be a useful additional treatment in MDD, due to their anti-inflammatory effects. Results of the current study are promising, but further studies are required to investigate the beneficial effects of probiotic interventions in depressed individuals.",2020,"In  IL-6  we found no significant main effects for group ( F (1,44)  = 1.33,  p  = ns) nor time ( F (1,44)  = 0.00,  p  = ns), but interaction was significant ( F (1,44)  = 5.67,  p  < 0.05).",['61 inpatients with MDD'],"['placebo', 'Multispecies Probiotic', 'Probiotics', 'probiotics']","['gene expression levels of  IL-6 ', 'gene expression of tumor necrosis factor ( TNF ), nuclear factor kappa B subunit 1 ( NFKB1 ) and interleukin-6 ( IL-6 ', 'IL-6  gene expression levels']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0079904', 'cui_str': 'Immunoglobulin Enhancer-Binding Protein'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}]",61.0,0.0611653,"In  IL-6  we found no significant main effects for group ( F (1,44)  = 1.33,  p  = ns) nor time ( F (1,44)  = 0.00,  p  = ns), but interaction was significant ( F (1,44)  = 5.67,  p  < 0.05).","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Reiter', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Susanne A', 'Initials': 'SA', 'LastName': 'Bengesser', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Anne-Christin', 'Initials': 'AC', 'LastName': 'Hauschild', 'Affiliation': 'Department of Mathematics & Computer Science, University of Marburg, 35043 Marburg, Germany.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Birkl-Töglhofer', 'Affiliation': 'Institute for Pathology, Neuropathology and Molecular Pathology, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Frederike T', 'Initials': 'FT', 'LastName': 'Fellendorf', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Platzer', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Färber', 'Affiliation': 'Institute of Psychology, University of Bamberg, 96047 Bamberg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Seidl', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Lilli-Marie', 'Initials': 'LM', 'LastName': 'Mendel', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Unterweger', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Lenger', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Mörkl', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Dalkner', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Birner', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Queissner', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Maget', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Pilz', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kohlhammer-Dohr', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Jolana', 'Initials': 'J', 'LastName': 'Wagner-Skacel', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Kreuzer', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schöggl', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Amberger-Otti', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Lahousen', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Leitner-Afschar', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Haybäck', 'Affiliation': 'Institute for Pathology, Neuropathology and Molecular Pathology, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Kapfhammer', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Reininghaus', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}]",Nutrients,['10.3390/nu12092575']
1459,32861306,Effect of collaborative care between traditional and faith healers and primary health-care workers on psychosis outcomes in Nigeria and Ghana (COSIMPO): a cluster randomised controlled trial.,"BACKGROUND


Traditional and faith healers (TFH) provide care to a large number of people with psychosis in many sub-Saharan African countries but they practise outside the formal mental health system. We aimed to assess the effectiveness and cost-effectiveness of a collaborative shared care model for psychosis delivered by TFH and primary health-care providers (PHCW).
METHODS


In this cluster-randomised trial in Kumasi, Ghana and Ibadan, Nigeria, we randomly allocated clusters (a primary care clinic and neighbouring TFH facilities) 1:1, stratified by size and country, to an intervention group or enhanced care as usual. The intervention included a manualised collaborative shared care delivered by trained TFH and PHCW. Eligible participants were adults (aged ≥18 years) newly admitted to TFH facilities with active psychotic symptoms (positive and negative syndrome scale [PANSS] score ≥60). The primary outcome, by masked assessments at 6 months, was the difference in psychotic symptom improvement as measured with the PANSS in patients in follow-up at 3 and 6 months. Patients exposure to harmful treatment practices, such as shackling, were also assessed at 3 and 6 months. Care costs were assessed at baseline, 3-month and 6-month follow-up, and for the entire 6 months of follow-up. This trial was registered with the National Institutes of Health Clinical Trial registry, NCT02895269.
FINDINGS


Between Sept 1, 2016, and May 3, 2017, 51 clusters were randomly allocated (26 intervention, 25 control) with 307 patients enrolled (166 [54%] in the intervention group and 141 [46%] in the control group). 190 (62%) of participants were men. Baseline mean PANSS score was 107·3 (SD 17·5) for the intervention group and 108·9 (18·3) for the control group. 286 (93%) completed the 6-month follow-up at which the mean total PANSS score for intervention group was 53·4 (19·9) compared with 67·6 (23·3) for the control group (adjusted mean difference -15·01 (95% CI -21·17 to -8·84; 0·0001). Harmful practices decreased from 94 (57%) of 166 patients at baseline to 13 (9%) of 152 at 6 months in the intervention group (-0·48 [-0·60 to -0·37] p<0·001) and from 59 (42%) of 141 patients to 13 (10%) of 134 in the control group (-0·33 [-0·45 to -0·21] p<0·001), with no significant difference between the two groups. Greater reductions in overall care costs were seen in the intervention group than in the control group. At the 6 month assessment, greater reductions in total health service and time costs were seen in the intervention group; however, cumulative costs over this period were higher (US $627 per patient vs $526 in the control group). Five patients in the intervention group had mild extrapyramidal side effects.
INTERPRETATION


A collaborative shared care delivered by TFH and conventional health-care providers for people with psychosis was effective and cost-effective. The model of care offers the prospect of scaling up improved care to this vulnerable population in settings with low resources.
FUNDING


US National Institute of Mental Health.",2020,"At the 6 month assessment, greater reductions in total health service and time costs were seen in the intervention group; however, cumulative costs over this period were higher (US $627 per patient vs $526 in the control group).","['Nigeria and Ghana (COSIMPO', '190 (62%) of participants were men', 'Eligible participants were adults (aged ≥18 years) newly admitted to TFH facilities with active psychotic symptoms (positive and negative syndrome scale [PANSS] score ≥60']","['Traditional and faith healers (TFH) provide care', 'intervention group or enhanced care as usual', 'collaborative care between traditional and faith healers and primary health-care workers', 'collaborative shared care model', 'manualised collaborative shared care delivered by trained TFH and PHCW']","['total health service and time costs', 'psychotic symptom improvement', 'Care costs', 'Harmful practices', 'effectiveness and cost-effectiveness', 'mean total PANSS score', 'cumulative costs', 'mild extrapyramidal side effects', 'overall care costs', 'Baseline mean PANSS score']","[{'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0335030', 'cui_str': 'Faith healer'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0335030', 'cui_str': 'Faith healer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",307.0,0.145641,"At the 6 month assessment, greater reductions in total health service and time costs were seen in the intervention group; however, cumulative costs over this period were higher (US $627 per patient vs $526 in the control group).","[{'ForeName': 'Oye', 'Initials': 'O', 'LastName': 'Gureje', 'Affiliation': 'WHO Collaborating Centre for Research and Training in Mental Health, Neurosciences and Substance Abuse, Department of Psychiatry, University of Ibadan, Ibadan, Nigeria. Electronic address: ogureje@com.ui.edu.ng.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Appiah-Poku', 'Affiliation': 'Department of Behavioural Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.'}, {'ForeName': 'Toyin', 'Initials': 'T', 'LastName': 'Bello', 'Affiliation': 'WHO Collaborating Centre for Research and Training in Mental Health, Neurosciences and Substance Abuse, Department of Psychiatry, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Kola', 'Affiliation': 'WHO Collaborating Centre for Research and Training in Mental Health, Neurosciences and Substance Abuse, Department of Psychiatry, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Araya', 'Affiliation': ""Department of Health Services and Population Research, King's College London, London, UK.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chisholm', 'Affiliation': 'Department of Mental Health and Substance Abuse, WHO, Geneva, Switzerland.'}, {'ForeName': 'Oluyomi', 'Initials': 'O', 'LastName': 'Esan', 'Affiliation': 'WHO Collaborating Centre for Research and Training in Mental Health, Neurosciences and Substance Abuse, Department of Psychiatry, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Harris', 'Affiliation': 'Department of Psychiatry, University of Liberia, Monrovia, Liberia.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Makanjuola', 'Affiliation': 'WHO Collaborating Centre for Research and Training in Mental Health, Neurosciences and Substance Abuse, Department of Psychiatry, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Caleb', 'Initials': 'C', 'LastName': 'Othieno', 'Affiliation': 'Department of Psychiatry, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'LeShawndra', 'Initials': 'L', 'LastName': 'Price', 'Affiliation': 'Department of Health and Human Services, National Institute of Mental Health, National Institutes of Health, US Department of Health and Human Services, Bethesda, MD, USA.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Seedat', 'Affiliation': 'Department of Psychiatry, Stellenbosch University, Cape Town, South Africa.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30634-6']
1460,32862232,The dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial: baseline characteristics.,"BACKGROUND


The Dapagliflozin and Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD; NCT03036150) trial was designed to assess the effect of the sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin on kidney and cardiovascular events in participants with CKD with and without type 2 diabetes (T2D). This analysis reports the baseline characteristics of those recruited, comparing them with those enrolled in other trials.
METHODS


In DAPA-CKD, 4304 participants with a urinary albumin:creatinine ratio (UACR) ≥200 mg/g and estimated glomerular filtration rate (eGFR) between 25 and 75 mL/min/1.73 m2 were randomized to dapagliflozin 10 mg once daily or placebo. Mean eGFR was 43.1 mL/min/1.73 m2 and median UACR was 949 mg/g (108 mg/mmol).
RESULTS


Overall, 2906 participants (68%) had a diagnosis of T2D and of these, 396 had CKD ascribed to a cause other than diabetes. The most common causes of CKD after diabetes (n = 2510) were ischaemic/hypertensive nephropathy (n = 687) and chronic glomerulonephritis (n = 695), of which immunoglobulin A nephropathy (n = 270) was the most common. A total of 4174 participants (97%) were receiving an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, 1882 (43.7%) diuretics, 229 (5.3%) mineralocorticoid receptor antagonists and 122 (2.8%) glucagon-like peptide 1 receptor agonists. In contrast to the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE), the DAPA-CKD trial enrolled participants with CKD due to diabetes and to causes other than diabetes. The mean eGFR of participants in the DAPA-CKD trial was 13.1 mL/min/1.73 m2 lower than in CREDENCE, similar to that in the Finerenone in Reducing Kidney Failure and Disease Progression in DKD (FIDELIO-DKD) trial and the Study Of diabetic Nephropathy with AtRasentan (SONAR).
CONCLUSIONS


Participants with a wide range of underlying kidney diseases receiving renin-angiotensin system blocking therapy have been enrolled in the DAPA-CKD trial. The trial will examine the efficacy and safety of dapagliflozin in participants with CKD Stages 2-4 and increased albuminuria, with and without T2D.",2020,Mean eGFR was 43.1 mL/min/1.73 ,"['participants with CKD with and without type 2 diabetes (T2D', 'CKD after diabetes (n\u2009=\u20092510) were ischaemic/hypertensive nephropathy (n\u2009=\u2009687) and chronic glomerulonephritis (n\u2009=\u2009695), of which immunoglobulin', '4174 participants (97%) were receiving an', ' 1882 (43.7%) diuretics, 229 (5.3%) mineralocorticoid receptor antagonists and 122 (2.8', 'Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE), the DAPA-CKD trial enrolled participants with CKD due to diabetes and to causes other than diabetes', 'participants with CKD Stages 2-4 and increased albuminuria, with and without T2D', 'Participants with a wide range of underlying kidney diseases receiving', 'chronic kidney disease (DAPA-CKD', '2906 participants (68%) had a diagnosis of T2D and of these, 396 had CKD ascribed to a cause other than diabetes', '4304 participants with a urinary albumin:creatinine ratio (UACR) ≥200']","['dapagliflozin 10\u2009mg once daily or placebo', 'renin-angiotensin system blocking therapy', 'glucagon-like peptide 1 receptor agonists', 'angiotensin-converting enzyme inhibitor or angiotensin receptor blocker', 'sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin', 'dapagliflozin']","['Kidney Failure and Disease Progression', 'efficacy and safety', 'glomerular filtration rate (eGFR', 'kidney and cardiovascular events', 'Mean eGFR', 'm2 and median UACR', 'mean eGFR']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0848548', 'cui_str': 'Hypertensive renal disease'}, {'cui': 'C0152451', 'cui_str': 'Chronic glomerulonephritis'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C2316786', 'cui_str': 'Chronic kidney disease stage 2'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C5191354', 'cui_str': '396'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",4304.0,0.0859358,Mean eGFR was 43.1 mL/min/1.73 ,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'Department of Renal Medicine, University College London, London, UK.'}, {'ForeName': 'Bergur V', 'Initials': 'BV', 'LastName': 'Stefansson', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Batiushin', 'Affiliation': 'Department of Nephrology, Rostov State Medical University, Rostov, Russia.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Bilchenko', 'Affiliation': 'Kharkiv Medical Academy of Postgraduate Education, Kharkiv, Ukraine.'}, {'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'Toronto General Hospital Research Institute, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Douthat', 'Affiliation': 'Department of Nephrology, Hospital Privado Universitario de Cordoba, Cordoba, Argentina.'}, {'ForeName': 'Jamie P', 'Initials': 'JP', 'LastName': 'Dwyer', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Escudero', 'Affiliation': 'Division of Nephrology, Hospital Arzobispo Loayza, Cayetano Heredia University, Lima, Peru.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pecoits-Filho', 'Affiliation': 'School of Medicine, Pontificia Universidade Catolica do Parana, Curitiba, Brazil.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Furuland', 'Affiliation': 'Department of Medical Sciences Renal Unit, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Górriz', 'Affiliation': 'Department of Nephrology, University Clinic Hospital, INCLIVA, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City, UT, USA.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Haller', 'Affiliation': 'Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Fan Fan', 'Initials': 'FF', 'LastName': 'Hou', 'Affiliation': 'Department of Medicine, Division of Nephrology, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China.'}, {'ForeName': 'Shin-Wook', 'Initials': 'SW', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Rey', 'Initials': 'R', 'LastName': 'Isidto', 'Affiliation': 'Healthlink Medical, Dental, Surgical Clinics and Diagnostics Center, Iloilo City, Philippines.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khullar', 'Affiliation': 'Department of Nephrology and Renal Transplant Medicine, Max Super Speciality Hospital, Saket, New Delhi, India.'}, {'ForeName': 'Patrick B', 'Initials': 'PB', 'LastName': 'Mark', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kashihara', 'Affiliation': 'Department of Nephrology and Hypertension, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Nowicki', 'Affiliation': 'Department of Nephrology, Hypertension and Kidney Transplantation, Medical University of Łódź, Łódź, Poland.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Persson', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Correa-Rotter', 'Affiliation': 'National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Toto', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Kausik', 'Initials': 'K', 'LastName': 'Umanath', 'Affiliation': 'Division of Nephrology and Hypertension, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Pham', 'Initials': 'P', 'LastName': 'Van Bui', 'Affiliation': 'Pham Ngoc Thach Medicine University, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Wittmann', 'Affiliation': 'Second Department of Medicine and Nephrology-Diabetes Center, University of Pécs Medical School, Pécs, Hungary.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Lindberg', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa234']
1461,32862247,Blunted cardiac output response to exercise in adolescents born preterm.,"PURPOSE


Premature birth is associated with lasting effects, including lower exercise capacity and pulmonary function, and is acknowledged as a risk factor for cardiovascular disease. The aim was to evaluate factors affecting exercise capacity in adolescents born preterm, including the cardiovascular and pulmonary responses to exercise, activity level and strength.
METHODS


21 preterm-born and 20 term-born adolescents (age 12-14 years) underwent strength and maximal exercise testing with thoracic bioimpedance monitoring. Baseline variables were compared between groups and ANCOVA was used to compare heart rate, cardiac output (Q) and stroke volume (SV) during exercise between groups while adjusting for body surface area.
RESULTS


Preterm-borns had lower maximal aerobic capacity than term-borns (2.0 ± 0.5 vs. 2.5 ± 0.5 L/min, p = 0.01) and lower maximal power (124 ± 26 vs. 153 ± 33 watts, p < 0.01), despite similar physical activity scores. Pulmonary function and muscular strength did not differ significantly. Although baseline Q and SV did not differ between groups, preterm adolescents had significantly lower cardiac index (Qi) at 50, 75 and 100% of maximal time to exhaustion, driven by SV volume index (SVi, 50% max time: 53.0 ± 9.0 vs. 61.6 ± 11.4; 75%: 51.7 ± 8.4 vs. 64.3 ± 11.1; 100%: 51.2 ± 9.3 vs. 64.3 ± 11.5 ml/m 2 , all p < 0.01), with similar heart rates.
CONCLUSION


Otherwise healthy and physically active adolescents born very preterm exhibit lower exercise capacity than term-born adolescents. Despite similar baseline cardiovascular values, preterm-born adolescents demonstrate significantly reduced Qi and SVi during incremental and maximal exercise.",2020,Pulmonary function and muscular strength did not differ significantly.,"['21 preterm-born and 20 term-born adolescents (age 12-14\xa0years) underwent', 'Otherwise healthy and physically active adolescents born very preterm exhibit lower exercise capacity than term-born adolescents', 'adolescents born preterm']",['strength and maximal exercise testing with thoracic bioimpedance monitoring'],"['cardiovascular and pulmonary responses to exercise, activity level and strength', 'Qi and SVi', 'Pulmonary function and muscular strength', 'heart rate, cardiac output (Q) and stroke volume (SV', 'cardiac index (Qi', 'physical activity scores', 'maximal aerobic capacity']","[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]",,0.0753262,Pulmonary function and muscular strength did not differ significantly.,"[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Haraldsdottir', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison, Madison, USA. haraldsdottir@ortho.wisc.edu.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Watson', 'Affiliation': 'Department of Orthopedics & Rehabilitation, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Pegelow', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Palta', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Tetri', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Levin', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'Melissa D', 'Initials': 'MD', 'LastName': 'Brix', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Centanni', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'Kara N', 'Initials': 'KN', 'LastName': 'Goss', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'Marlowe M', 'Initials': 'MM', 'LastName': 'Eldridge', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison, Madison, USA.'}]",European journal of applied physiology,['10.1007/s00421-020-04480-9']
1462,32866967,Sustained Maternal Hyperandrogenism During PCOS Pregnancy Reduced by Metformin in Non-obese Women Carrying a Male Fetus.,"CONTEXT


Large, longitudinal studies on androgen levels in pregnant women with polycystic ovary syndrome (PCOS) are lacking. While metformin has a mild androgen-lowering effect in non-pregnant women with PCOS, its effects on maternal androgen levels in pregnancy are less well understood.
OBJECTIVE


To describe androgen patterns in pregnant women with PCOS and in healthy control women, and to explore the potential effects of metformin on maternal androgen levels in PCOS.
DESIGN AND SETTING


A post hoc analysis from a randomized, placebo-controlled, multicenter study carried out at 11 secondary care centers and a longitudinal single-center study on healthy pregnant women in Norway.
PARTICIPANTS


A total of 262 women with PCOS and 119 controls.
INTERVENTION


The participants with PCOS were randomly assigned to metformin (2 g daily) or placebo, from first trimester to delivery.
MAIN OUTCOME MEASURES


Androstenedione (A4), testosterone (T), sex-hormone binding globulin (SHBG), and free testosterone index (FTI) at 4 time points in pregnancy.
RESULTS


Women with PCOS versus healthy controls had higher A4, T, and FTI, and lower SHBG at all measured time points in pregnancy. In the overall cohort of women with PCOS, metformin had no effect on A4, T, SHBG, and FTI. In subgroup analyses, metformin reduced A4 (P = 0.019) in nonobese women. Metformin also reduced A4 (P = 0.036), T (P = 0.023), and SHBG (P = 0.010) levels through pregnancy in mothers with a male fetus.
CONCLUSION


Metformin had no effect on maternal androgens in PCOS pregnancies. In subgroup analyses, a modest androgen-lowering effect was observed in nonobese women with PCOS. In PCOS women carrying a male fetus, metformin exhibited an androgen-lowering effect.",2020,"Metformin also reduced A4 (p=0.036), T (p=0.023) and SHBG (p=0.010) levels through pregnancy in mothers with a male foetus.
","['pregnant women with PCOS, and healthy control women', '11 secondary care centers and a longitudinal single-center study on healthy pregnant women in Norway', 'mothers with a male foetus', 'pregnant women with polycystic ovary syndrome (PCOS', 'non-obese pregnant women with PCOS', '262 women with PCOS, and 119 controls', 'Women with PCOS vs. healthy controls', 'healthy pregnant women', 'non-obese women carrying a male foetus', 'participants with PCOS']","['placebo', 'metformin', 'Metformin']","['maternal androgens', 'A4, T, SHBG and FTI', 'androstenedione levels', 'SHBG', 'modest androgen-lowering effect', 'androstenedione and testosterone levels', 'higher A4, T and FTI, and lower SHBG', 'Androstenedione (A4), testosterone (T), sex-hormone binding globulin (SHBG) and free-testosterone-index (FTI', 'maternal androgen levels']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3658282', 'cui_str': 'Secondary Referral Center'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0337432', 'cui_str': 'Androstenedione measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0002860', 'cui_str': 'Androstenedione'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}]",262.0,0.315689,"Metformin also reduced A4 (p=0.036), T (p=0.023) and SHBG (p=0.010) levels through pregnancy in mothers with a male foetus.
","[{'ForeName': 'Frida', 'Initials': 'F', 'LastName': 'Andræ', 'Affiliation': 'Department of Obstetrics and Gynecology, Nordlandssykehuset, Bodø, Norway.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Abbott', 'Affiliation': 'Wisconsin National Primate Research Centre, University of Wisconsin, Madison, WI.'}, {'ForeName': 'Solhild', 'Initials': 'S', 'LastName': 'Stridsklev', 'Affiliation': 'Department of Obstetrics and Gynecology, St Olavs hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Anne Vibeke', 'Initials': 'AV', 'LastName': 'Schmedes', 'Affiliation': 'Biochemistry and Immunology, Lillebælt Hospital, Vejle, Denmark.'}, {'ForeName': 'Ingrid Hov', 'Initials': 'IH', 'LastName': 'Odsæter', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Vanky', 'Affiliation': 'Department of Obstetrics and Gynecology, St Olavs hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Salvesen', 'Affiliation': 'Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa605']
1463,32867053,Seasonal Antimicrobial Activity of the Airway: Post-Hoc Analysis of a Randomized Placebo-Controlled Double-Blind Trial.,"BACKGROUND


It is widely unknown why respiratory infections follow a seasonal pattern. Variations in ultraviolet B (UVB) light during seasons affects cutaneous synthesis of vitamin D 3 . Serum vitamin D concentration influences the expression of airway surface liquid (ASL) antimicrobial peptides such as LL-37.
OBJECTIVE


We sought to determine the effect of seasons on serum vitamin D levels and ASL antimicrobial activity.
METHODS


Forty participants, 18-60 years old, were randomized 1:1 to receive 90 days of 1000 IU vitamin D 3  or placebo. We collected ASL via bronchoscopy and measured serum 25(OH) vitamin D from participants before and after intervention across seasons. We measured ASL antimicrobial activity by challenging samples with bioluminescent  Staphylococcus aureus  and measured relative light units (RLUs) after four minutes. We also investigated the role of LL-37 using a monoclonal neutralizing antibody.
RESULTS


We found that participants, prior to any intervention, during summer-fall ( n  = 20) compared to winter-spring ( n  = 20) had (1) decreased live bacteria after challenge (5542 ± 175.2 vs. 6585 ± 279 RLU,  p  = 0.003) and (2) higher serum vitamin D (88.25 ± 24.25 vs. 67.5 ± 45.25 nmol/L,  p  = 0.026). Supplementation with vitamin D 3  increased vitamin D levels and restored ASL antimicrobial activity only during the winter-spring. The increased ASL antimicrobial activity seen during the summer-fall was abrogated by adding the LL-37 neutralizing antibody.
CONCLUSION


ASL kills bacteria more effectively during the summer-fall compared to the winter-spring. Supplementation of vitamin D during winter-spring restores ASL antimicrobial activity by increasing the expression of antimicrobial peptides including LL-37.",2020,Supplementation of vitamin D during winter-spring restores ASL antimicrobial activity by increasing the expression of antimicrobial peptides including LL-37.,"['Forty participants, 18-60 years old']","['vitamin D 3  or placebo', 'LL-37', 'Placebo', 'vitamin D']","['Seasonal Antimicrobial Activity', 'ASL antimicrobial activity', 'serum 25(OH', 'live bacteria', 'vitamin D levels', 'serum vitamin D']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042950', 'cui_str': 'Volition'}]","[{'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C1271650', 'cui_str': 'Antimicrobial activity'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}]",40.0,0.191566,Supplementation of vitamin D during winter-spring restores ASL antimicrobial activity by increasing the expression of antimicrobial peptides including LL-37.,"[{'ForeName': 'Luis G', 'Initials': 'LG', 'LastName': 'Vargas Buonfiglio', 'Affiliation': 'Department of Internal Medicine, Carver College of Medicine Iowa City, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Oriana G', 'Initials': 'OG', 'LastName': 'Vanegas Calderon', 'Affiliation': 'Department of Pediatrics, Carver College of Medicine Iowa City, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Cano', 'Affiliation': 'Department of Internal Medicine, Carver College of Medicine Iowa City, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Jacob E', 'Initials': 'JE', 'LastName': 'Simmering', 'Affiliation': 'Department of Internal Medicine, Carver College of Medicine Iowa City, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Polgreen', 'Affiliation': 'Department of Internal Medicine, Carver College of Medicine Iowa City, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Zabner', 'Affiliation': 'Department of Internal Medicine, Carver College of Medicine Iowa City, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Alicia K', 'Initials': 'AK', 'LastName': 'Gerke', 'Affiliation': 'Department of Internal Medicine, Carver College of Medicine Iowa City, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Alejandro P', 'Initials': 'AP', 'LastName': 'Comellas', 'Affiliation': 'Department of Internal Medicine, Carver College of Medicine Iowa City, University of Iowa, Iowa City, IA 52242, USA.'}]",Nutrients,['10.3390/nu12092602']
1464,32867083,"Effect of White Potatoes on Subjective Appetite, Food Intake, and Glycemic Response in Healthy Older Adults.","The objective of this study was to determine the effect of white potato cooking methods on subjective appetite, short-term food intake (FI), and glycemic response in healthy older adults. Using a within-subject, repeated-measures design, 20 participants (age: 70.4 ± 0.6 y) completed, in random order, five treatment conditions: three potato treatments (baked potatoes, mashed potatoes, and French fries), an isocaloric control treatment (white bread), or a fasting condition (meal skipping). Subjective appetite and glycemic response were measured for 120 min using visual analogue scales and capillary blood samples, respectively. Lunch FI was measured with an ad libitum pizza meal at 120 min. Change from baseline subjective appetite ( p  < 0.001) and lunch FI ( p  < 0.001) were lower after all test treatments compared with meal skipping ( p  < 0.001), but did not differ among test treatments. Cumulative FI (test treatment + lunch FI) did not differ among treatment conditions. Blood glucose concentrations were higher after all test treatments compared with meal skipping ( p  < 0.001), but were not different from each other. In healthy older adults, white potatoes suppressed subjective appetite and lunch FI compared with meal skipping, suggesting white potatoes do not bypass regulatory control mechanisms of FI.",2020,"Blood glucose concentrations were higher after all test treatments compared with meal skipping ( p  < 0.001), but were not different from each other.","['Healthy Older Adults', '20 participants (age: 70.4 ± 0.6 y) completed, in random order, five treatment conditions: three', 'healthy older adults']","['white potato cooking methods', 'potato treatments (baked potatoes, mashed potatoes, and French fries), an isocaloric control treatment (white bread), or a fasting condition (meal skipping', 'Lunch FI was measured with an ad libitum pizza meal', 'White Potatoes']","['lunch FI', 'Blood glucose concentrations', 'subjective appetite, short-term food intake (FI), and glycemic response', 'baseline subjective appetite', 'Cumulative FI', 'Subjective Appetite, Food Intake, and Glycemic Response', 'Subjective appetite and glycemic response']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452550', 'cui_str': 'White bread'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0453577', 'cui_str': 'Pizza'}]","[{'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",20.0,0.0325709,"Blood glucose concentrations were higher after all test treatments compared with meal skipping ( p  < 0.001), but were not different from each other.","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bellissimo', 'Affiliation': 'School of Nutrition, Faculty of Community Services, Ryerson University, 350 Victoria Street, Toronto, ON M5B 2K3, Canada.'}, {'ForeName': 'Robena', 'Initials': 'R', 'LastName': 'Amalraj', 'Affiliation': 'School of Nutrition, Faculty of Community Services, Ryerson University, 350 Victoria Street, Toronto, ON M5B 2K3, Canada.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'School of Nutrition, Faculty of Community Services, Ryerson University, 350 Victoria Street, Toronto, ON M5B 2K3, Canada.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Brett', 'Affiliation': 'School of Nutrition, Faculty of Community Services, Ryerson University, 350 Victoria Street, Toronto, ON M5B 2K3, Canada.'}, {'ForeName': 'Julia O', 'Initials': 'JO', 'LastName': 'Totosy de Zepetnek', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, 3737 Wascana Parkway, Regina, SK S4S 0A2, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Proteau', 'Affiliation': 'School of Nutrition, Faculty of Community Services, Ryerson University, 350 Victoria Street, Toronto, ON M5B 2K3, Canada.'}, {'ForeName': 'Dérick', 'Initials': 'D', 'LastName': 'Rousseau', 'Affiliation': 'Department of Chemistry and Biology, Faculty of Science, Ryerson University, 350 Victoria Street, Toronto, ON M5B 2K3, Canada.'}]",Nutrients,['10.3390/nu12092606']
1465,32870155,A simplified and sensitive LC-APCI-MS/MS method for the quantification of propofol: Application to a bioequivalence study in healthy Chinese subjects.,"OBJECTIVES


Propofol has become the preferred anesthetic in recent years due to its desirable pharmacologic properties. However, propofol possesses a very narrow therapeutic window between the favorable clinical effect and potentially lethal toxicity, therefore, a rapid, simplified, and sensitive liquid chromatography-atmospheric pressure chemical ionization tandem mass spectrometry (LC-APCI-MS/MS) method is presented in this study for the quantification of propofol in human plasma using the isotope-labeled internal standard (IS) of propofol-d17, and then applied in a bioequivalence study.
MATERIALS AND METHODS


Sample preparation was accomplished through simple one-step precipitation of plasma protein with acetonitrile. Chromatographic separation was acquired on an ACE Excel 3 Super C 18  column (2.1 × 50 mm, 3 µm) using gradient elution at a flow rate of 0.5 mL/min. The MS detection was achieved in the negative ion APCI by multiple reaction monitoring (MRM) mode using the transitions of m/z 177.2 → 161.0 for propofol and m/z 194.2 → 174.2 for IS, respectively. 30 healthy Chinese subjects were enrolled in the open-label, randomized, two-period, two-sequence, cross-over bioequivalence study after single-dose intravenous administration of propofol medium-chain triglyceride and long-chain triglyceride (MCT/LCT).
RESULTS


The current method was precise and accurate at a linearity range of 4.00 - 1,000 ng/mL without severe interference from the plasma matrix. The inter- and intra-batch precision (2.3 to 15.8%) and accuracy (-4.4 to 3.0%), IS-normalized matrix effect (coefficient of variation ≤ 4.6%), extraction recovery (107.1 - 117.1%), stability (coefficient of variation ≤ 8.0%), and dilution integrity were all within the acceptable range. The 90% confidence intervals (CIs) of the ratios of the geometric means (test/reference) were 86.44 - 104.88% for C max , 96.30 - 104.52% for AUC 0-t , and 96.56 - 105.05% for AUC 0-∞ , which were all within the predefined bioequivalence range of 80 - 125%. Besides, both propofol MCT/LCT preparations were well tolerated in healthy Chinese subjects, and there were no serious adverse events during the study.
CONCLUSION


The method is more simplified and sensitive than the previously reported modes of propofol detection. The two propofol MCT/LCT preparations were considered to be bioequivalent.",2020,"The inter- and intra-batch precision (2.3 to 15.8%) and accuracy (-4.4 to 3.0%), IS-normalized matrix effect (coefficient of variation ≤ 4.6%), extraction recovery (107.1 - 117.1%), stability (coefficient of variation ≤ 8.0%), and dilution integrity were all within the acceptable range.","['1,000', '30 healthy Chinese subjects', 'healthy Chinese subjects']","['propofol', 'propofol MCT/LCT', 'Propofol', 'propofol medium-chain triglyceride and long-chain triglyceride']","['extraction recovery', 'inter- and intra-batch precision', 'dilution integrity', 'accuracy', 'MS detection']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1564283', 'cui_str': 'Propofol MCT'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C0556091', 'cui_str': 'Long chain triglyceride supplementation'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0079240', 'cui_str': 'Dilution'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",,0.0205945,"The inter- and intra-batch precision (2.3 to 15.8%) and accuracy (-4.4 to 3.0%), IS-normalized matrix effect (coefficient of variation ≤ 4.6%), extraction recovery (107.1 - 117.1%), stability (coefficient of variation ≤ 8.0%), and dilution integrity were all within the acceptable range.","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'KeLi', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': ''}, {'ForeName': 'XuanWei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203821']
1466,32871454,Difficulties in developmental follow-up of preterm neonates in a randomised-controlled trial of Bifidobacterium breve M16-V - Experience from Western Australia.,"BACKGROUND


Probiotics may be neuroprotective for preterm neonates due to their anti-inflammatory effects and ability to facilitate nutrition.
AIM


To assess long-term effects of early probiotic supplementation on neuropsychological development in preterm infants.
STUDY DESIGN


Follow up study.
SUBJECTS


Children at age 3 to 5 years who had participated as preterm infants (<33 week) in the randomised controlled trial.
OUTCOMES


Primary: Continuous early learning composite measure derived from the Mullen's Scale of Early Learning (MSEL). Other outcomes were assessed by the Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition.
MEASURES


Continuous scores derived from all the measures.
RESULTS


67 children of the 159 participants (42%) (Probiotic: 36/79, Placebo: 31/80) were followed-up for at least one neuropsychological assessment. All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children. Multivariable analysis of MSEL composite score showed no evidence of probiotic effect univariately, or after adjustment for gestation, intrauterine growth restriction, Apgar <7 at 5 min and age at assessment (adjusted mean effect in probiotic group: -2.7, 95% CI -8.5-3.0, p = 0.349).
CONCLUSION


There was no significant effect on neurodevelopment of children assessed at the age of 3 to 5 years who participated as preterm neonates in the RCT of B. breve M-16V. The validity of these results is limited by the reduced sample size due to high rate of loss to follow up.",2020,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"['preterm infants', 'Children at age 3 to 5\xa0years who had participated as preterm infants (<33\xa0week', 'preterm neonates', '67 children of the 159 participants (42', 'from Western Australia']","['early probiotic supplementation', 'Placebo', 'Bifidobacterium breve M16-V - Experience', 'M-16V']","[""Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition"", ""Mullen's Scale of Early Learning (MSEL""]","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C3875061', 'cui_str': 'Developmental, dimensional and diagnostic interview'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",159.0,0.215666,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia. Electronic address: sachin.agrawal@health.wa.gov.au.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Pestell', 'Affiliation': 'School of Psychological Science, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Granich', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Neonatal Pediatrics, Perth Children Hospital, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nathan', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Women and Infants Research Foundation, King Edward Memorial Hospital for Women, 374, Bagot Road, Subiaco, Perth, WA, Australia.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Wray', 'Affiliation': 'Child Development Centre, 4/16 Rheola St, West Perth, WA 6005, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.'}, {'ForeName': 'A J O', 'Initials': 'AJO', 'LastName': 'Whitehouse', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Patole', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.'}]",Early human development,['10.1016/j.earlhumdev.2020.105165']
1467,32757521,Subcutaneous or Transvenous Defibrillator Therapy.,"BACKGROUND


The subcutaneous implantable cardioverter-defibrillator (ICD) was designed to avoid complications related to the transvenous ICD lead by using an entirely extrathoracic placement. Evidence comparing these systems has been based primarily on observational studies.
METHODS


We conducted a noninferiority trial in which patients with an indication for an ICD but no indication for pacing were assigned to receive a subcutaneous ICD or transvenous ICD. The primary end point was the composite of device-related complications and inappropriate shocks; the noninferiority margin for the upper boundary of the 95% confidence interval for the hazard ratio (subcutaneous ICD vs. transvenous ICD) was 1.45. A superiority analysis was prespecified if noninferiority was established. Secondary end points included death and appropriate shocks.
RESULTS


A total of 849 patients (426 in the subcutaneous ICD group and 423 in the transvenous ICD group) were included in the analyses. At a median follow-up of 49.1 months, a primary end-point event occurred in 68 patients in the subcutaneous ICD group and in 68 patients in the transvenous ICD group (48-month Kaplan-Meier estimated cumulative incidence, 15.1% and 15.7%, respectively; hazard ratio, 0.99; 95% confidence interval [CI], 0.71 to 1.39; P = 0.01 for noninferiority; P = 0.95 for superiority). Device-related complications occurred in 31 patients in the subcutaneous ICD group and in 44 in the transvenous ICD group (hazard ratio, 0.69; 95% CI, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95% CI, 0.89 to 2.30). Death occurred in 83 patients in the subcutaneous ICD group and in 68 in the transvenous ICD group (hazard ratio, 1.23; 95% CI, 0.89 to 1.70); appropriate shocks occurred in 83 and 57 patients, respectively (hazard ratio, 1.52; 95% CI, 1.08 to 2.12).
CONCLUSIONS


In patients with an indication for an ICD but no indication for pacing, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks. (Funded by Boston Scientific; PRAETORIAN ClinicalTrials.gov number, NCT01296022.).",2020,"Device-related complications occurred in 31 patients in the subcutaneous ICD group and in 44 in the transvenous ICD group (hazard ratio, 0.69; 95% CI, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95% CI, 0.89 to 2.30).","['patients with an indication for an ICD but no indication for pacing', '849 patients (426 in the subcutaneous ICD group and 423 in the transvenous ICD group) were included in the analyses']","['Subcutaneous or Transvenous Defibrillator Therapy', 'subcutaneous implantable cardioverter-defibrillator (ICD', 'subcutaneous ICD or transvenous ICD', 'subcutaneous ICD', 'transvenous ICD']","['death and appropriate shocks', 'inappropriate shocks', 'composite of device-related complications and inappropriate shocks; the noninferiority margin for the upper boundary of the 95% confidence interval for the hazard ratio (subcutaneous ICD vs. transvenous ICD', 'Device-related complications', 'appropriate shocks', 'Death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0521090', 'cui_str': 'No indication of'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C0180307', 'cui_str': 'Defibrillator'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0522521', 'cui_str': 'Transvenous approach'}]",849.0,0.240788,"Device-related complications occurred in 31 patients in the subcutaneous ICD group and in 44 in the transvenous ICD group (hazard ratio, 0.69; 95% CI, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95% CI, 0.89 to 2.30).","[{'ForeName': 'Reinoud E', 'Initials': 'RE', 'LastName': 'Knops', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Louise R A', 'Initials': 'LRA', 'LastName': 'Olde Nordkamp', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Peter-Paul H M', 'Initials': 'PHM', 'LastName': 'Delnoy', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Lucas V A', 'Initials': 'LVA', 'LastName': 'Boersma', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Kuschyk', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Mikhael F', 'Initials': 'MF', 'LastName': 'El-Chami', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Bonnemeier', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Elijah R', 'Initials': 'ER', 'LastName': 'Behr', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Tom F', 'Initials': 'TF', 'LastName': 'Brouwer', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kääb', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Suneet', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Anne-Floor B E', 'Initials': 'ABE', 'LastName': 'Quast', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Lonneke', 'Initials': 'L', 'LastName': 'Smeding', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Willeke', 'Initials': 'W', 'LastName': 'van der Stuijt', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'de Weger', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Koen C', 'Initials': 'KC', 'LastName': 'de Wilde', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Nick R', 'Initials': 'NR', 'LastName': 'Bijsterveld', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Richter', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Brouwer', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Joris R', 'Initials': 'JR', 'LastName': 'de Groot', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Kirsten M', 'Initials': 'KM', 'LastName': 'Kooiman', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Pier D', 'Initials': 'PD', 'LastName': 'Lambiase', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Neuzil', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Vernooy', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Alings', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Tim R', 'Initials': 'TR', 'LastName': 'Betts', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Frank A L E', 'Initials': 'FALE', 'LastName': 'Bracke', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Martin C', 'Initials': 'MC', 'LastName': 'Burke', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Jonas S S G', 'Initials': 'JSSG', 'LastName': 'de Jong', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Wright', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Arthur A M', 'Initials': 'AAM', 'LastName': 'Wilde', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915932']
1468,32845968,Long-term Change in Physiological Markers and Cognitive Performance in Type 2 Diabetes: The Look AHEAD Study.,"CONTEXT


The effects of physiological improvements on cognitive function among persons with type 2 diabetes mellitus (T2DM) are not fully understood.
OBJECTIVE


To determine whether improvements in physiological markers (body weight, blood sugar control, and physical activity) during intensive lifestyle intervention (ILI) are associated with enhancements in cognitive function in older adults with T2DM.
DESIGN


Multisite randomized controlled trial.
SETTING


Academic research centers.
PATIENTS OR OTHER PARTICIPANTS


Participants were aged 45-76 years, with T2DM.
INTERVENTION


The Action for Health in Diabetes (Look AHEAD) study, a randomized, controlled clinical trial of ILI.
MAIN OUTCOME MEASURE


Two to 3 cognitive assessments were collected from 1089 participants, the first and last occurring a mean (standard deviation) of 8.6 (1.0) and 11.5 (0.7) years after enrollment.
RESULTS


Greater improvement in blood sugar control was associated with better cognitive scores (fasting glucose and Rey Auditory Verbal Learning Test [AVLT]: P = 0.0148; fasting glucose and Digit Symbol Coding (DSC): P = 0.0360; HbA1C and DSC: P = 0.0477); but weight loss had mixed associations with cognitive scores (greater body mass index [BMI] reduction and worse AVLT overall: P = 0.0053; and greater BMI reduction and better DSC scores among those overweight but not obese at baseline: P = 0.010). Associations were strongest among those who were overweight (not obese) at baseline, and among those with a history of cardiovascular disease (CVD) at baseline.
CONCLUSIONS


Improvements in glycemic control, but not necessarily weight status, during ILI may be associated with better subsequent cognitive performance. These associations may differ by adiposity and CVD history.",2020,"RESULTS


Greater improvements in blood sugar control were associated with better cognitive scores (fasting glucose and Rey Auditory Verbal Learning Test, AVLT: p=.0148, fasting glucose and Digit Symbol Coding, DSC:","['persons with type 2 diabetes mellitus (T2DM', 'Diabetes', 'Academic research centers', 'type 2 diabetes', 'Participants were aged 45-76 years with T2DM', '1089 participants, the first and last occurring a mean [standard deviation] of 8.6 [1.0] and 11.5 [.7', 'older adults with T2DM']","['HbA1C and DSC', 'intensive lifestyle intervention (ILI']","['BMI reduction and better DSC scores', 'blood sugar control', 'physiological markers and cognitive performance', 'cognitive function', 'cognitive scores (fasting glucose and Rey Auditory Verbal Learning Test, AVLT: p=.0148, fasting glucose and Digit Symbol Coding, DSC', 'physiological markers (body weight, blood sugar control, and physical activity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",1089.0,0.0476723,"RESULTS


Greater improvements in blood sugar control were associated with better cognitive scores (fasting glucose and Rey Auditory Verbal Learning Test, AVLT: p=.0148, fasting glucose and Digit Symbol Coding, DSC:","[{'ForeName': 'Owen T', 'Initials': 'OT', 'LastName': 'Carmichael', 'Affiliation': 'Biomedical Imaging Center, Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Gareth R', 'Initials': 'GR', 'LastName': 'Dutton', 'Affiliation': 'Department of Medicine, Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Hayden', 'Affiliation': 'Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Horton', 'Affiliation': 'Joslin Diabetes Center, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'F Xavier', 'Initials': 'FX', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Division of Endocrinology, Obesity/Nutrition Research Center, Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, The University of Tennessee Health Science Center, Memphis, Tennessee.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Rapp', 'Affiliation': 'Department of Psychiatry & Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Spira', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Division of Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa591']
1469,32856168,Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.,"Item response theory (IRT) was used to characterize the time course of lower urinary tract symptoms due to benign prostatic hyperplasia (BPH-LUTS) measured by item-level International Prostate Symptom Scores (IPSS). The Fisher information content of IPSS items was determined and the power to detect a drug effect using the IRT approach was examined. Data from 403 patients with moderate-to-severe BPH-LUTS in a placebo-controlled phase II trial studying the effect of degarelix over 6 months were used for modeling. Three pharmacometric models were developed: a model for total IPSS, a unidimensional IRT model, and a bidimensional IRT model, the latter separating voiding and storage items. The population-level time course of BPH-LUTS in all models was described by initial improvement followed by worsening. In the unidimensional IRT model, the combined information content of IPSS voiding items represented 72% of the total information content, indicating that the voiding subscore may be more sensitive to changes in BPH-LUTS compared with the storage subscore. The pharmacometric models showed considerably higher power to detect a drug effect compared with a cross-sectional and while-on-treatment analysis of covariance, respectively. Compared with the sample size required to detect a drug effect at 80% power with the total IPSS model, a reduction of 5.9% and 11.7% was obtained with the unidimensional and bidimensional IPSS IRT model, respectively. Pharmacometric IRT analysis of the IPSS within BPH-LUTS may increase the precision and efficiency of treatment effect assessment, albeit to a more limited extent compared with applications in other therapeutic areas.",2020,The Fisher information content of IPSS items was determined and the power to detect a drug effect using the IRT approach was examined.,"['403 patients with moderate-to-severe BPH-LUTS in a', 'Patients with Lower Urinary Tract Symptoms']","['degarelix', 'placebo']",['Item response theory (IRT'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}]","[{'cui': 'C1455035', 'cui_str': 'degarelix'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],403.0,0.0227785,The Fisher information content of IPSS items was determined and the power to detect a drug effect using the IRT approach was examined.,"[{'ForeName': 'Yassine Kamal', 'Initials': 'YK', 'LastName': 'Lyauk', 'Affiliation': 'Translational Medicine, Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300, Copenhagen, Denmark. yassinekamallyauk@gmail.com.'}, {'ForeName': 'Daniël M', 'Initials': 'DM', 'LastName': 'Jonker', 'Affiliation': 'Translational Medicine, Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300, Copenhagen, Denmark.'}, {'ForeName': 'Trine Meldgaard', 'Initials': 'TM', 'LastName': 'Lund', 'Affiliation': 'Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Hooker', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Mats O', 'Initials': 'MO', 'LastName': 'Karlsson', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}]",The AAPS journal,['10.1208/s12248-020-00500-w']
1470,32857445,Effect of varenicline directly observed therapy versus varenicline self-administered therapy on varenicline adherence and smoking cessation in methadone-maintained smokers: a randomized controlled trial.,"BACKGROUND AND AIMS


Level of adherence to tobacco cessation medication regimens is believed to be causally related to medication effectiveness. This study aimed to evaluate the efficacy of varenicline directly observed therapy (DOT) on varenicline adherence and smoking cessation rates among smokers with opioid use disorder (OUD) receiving methadone treatment.
DESIGN


Multicenter, parallel-group two-arm randomized controlled trial.
SETTING


Urban opioid treatment program (OTP) in the Bronx, New York, USA.
PARTICIPANTS


Daily smokers of ≥ 5 cigarettes/day, interested in quitting (ladder of change score 6-8), in methadone treatment for ≥ 3 months, attending OTP ≥ 3 days/week. Participants' mean age was 49 years, 56% were male, 44% Latino, 30% Black, and they smoked a median of 10 cigarettes/day.
INTERVENTIONS


Individual, block, random assignment to 12 weeks of varenicline, either directly observed with methadone (DOT, n = 50) or via unsupervised self-administered treatment (SAT, n = 50).
MEASUREMENTS


The primary outcome was adherence measured by pill count. The secondary outcome was 7-day point prevalence tobacco abstinence verified by expired carbon monoxide (CO) < 8 parts per million.
FINDINGS


Retention at 24 weeks was 92%. Mean adherence was 78.5% [95% confidence interval (CI) = 71.8-85.2%] in the DOT group versus 61.8% in the SAT group (95% CI = 55.0-68.6%); differences were driven by DOT effects in the first 6 weeks. CO-verified abstinence did not differ between groups during the intervention (P = 0.26), but was higher in the DOT than the SAT group at intervention end (DOT = 18% versus SAT = 10%, difference = 8%, 95% CI = -13, 28); this difference was not significant (P = 0.39) and was not sustained at 24-week follow-up.
CONCLUSIONS


Among daily smokers attending opioid treatment programs, opioid treatment program-based varenicline directly observed therapy was associated with early increases in varenicline adherence compared with self-administered treatment, but findings were inconclusive as to whether directly observed therapy was associated with a difference in tobacco abstinence.",2020,Mean adherence was 78.5% (95% confidence interval (CI) 71.8-85.2%) in the DOT group versus 61.8% in the SAT group (95% CI 55.0-68.6%); differences were driven by DOT effects in the first 6 weeks.,"['methadone-maintained smokers', 'smokers with opioid use disorder (OUD) receiving methadone treatment', 'Urban opioid treatment program (OTP) in the Bronx, New York, USA.\nPARTICIPANTS\n\n\nDaily smokers of ≥5 cigarettes/day', ""Participants' mean age was 49 years, 56% were male, 44% Latino, 30% Black, and they smoked a median of 10 cigarettes/day""]","['varenicline', 'varenicline self-administered therapy', 'varenicline, either directly observed with methadone (DOT, n=50) or via unsupervised self-administration (SAT, n=50', 'varenicline directly observed therapy (DOT']","['varenicline adherence', '7-day point prevalence tobacco abstinence verified by expired CO<8 parts per million', 'Mean adherence', 'CO-verified abstinence', 'tobacco abstinence', 'adherence measured by pill count', 'varenicline adherence and smoking cessation rates', 'varenicline adherence and smoking cessation']","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0647859', 'cui_str': 'AM 49'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0872145', 'cui_str': 'Directly Observed Therapy'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0037216', 'cui_str': 'SITS'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",,0.219717,Mean adherence was 78.5% (95% confidence interval (CI) 71.8-85.2%) in the DOT group versus 61.8% in the SAT group (95% CI 55.0-68.6%); differences were driven by DOT effects in the first 6 weeks.,"[{'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Nahvi', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Tangeria R', 'Initials': 'TR', 'LastName': 'Adams', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Ning', 'Affiliation': ''}, {'ForeName': 'Chenshu', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Arnsten', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15240']
1471,32858860,Composition of Coloured Gastric Residuals in Extremely Preterm Infants-A Nested Prospective Observational Study.,"Green gastric residuals (GR) are often considered as a sign of feed intolerance and discarded in preterm infants. Probiotics are known to enhance feed tolerance in preterm infants. To assess the composition (primary outcome) and volume of discarded green GRs, and feeding outcomes in extremely preterm (EP) infants in a probiotic trial, composition of pale and dark green GRs in the first two weeks of life from EP infants (<28 weeks) in a randomized controlled trial (RCT: SiMPro) of single vs. three-strain probiotics was assessed. Feeding outcomes included time to full feeds (TFF: 150 mL/kg/day) and duration of parenteral nutrition (PN). EP infants given placebo in our previous probiotic RCT served as the reference group. Analysis involved linear regression modelling with clustered standard errors for repeated measurements. GRs of 74/103 from 39 SiMPro infants (18: single-strain, 21: three-strain) were analyzed. Bile acid content was higher but statistically insignificant (825.79 vs. 338.1 µmol/L;  p  = 0.12) in dark vs. pale green GRs. Mean (95% confidence interval) fat, nitrogen, and carbohydrate loss in GRs over the study period was 0.02 g (0.01-0.03), 0.011 g (0.009-0.013), and 0.05 g (0.04-0.06), respectively. Overall, SiMPro infants had shorter median TFF (10 vs. 14 days,  p  = 0.02) and duration of PN (10 vs. 16 days,  p  = 0.022) compared with control group infants. Z scores for growth parameters at discharge were comparable. Discarding dark green GRs meant higher loss of bile acids during early enteral nutrition in EP infants. Probiotic supplementation was associated with reduced TFF and duration of PN.",2020,"Overall, SiMPro infants had shorter median TFF (10 vs. 14 days,  p  = 0.02) and duration of PN (10 vs. 16 days,  p  = 0.022) compared with control group infants.","['preterm infants', 'EP infants', 'Extremely Preterm Infants', 'GRs of 74/103 from 39 SiMPro infants (18: single-strain, 21: three-strain) were analyzed']","['Discarding dark green GRs', 'Probiotic supplementation', 'placebo']","['nitrogen, and carbohydrate loss in GRs', 'time to full feeds (TFF: 150 mL/kg/day) and duration of parenteral nutrition (PN', 'bile acids', 'composition of pale and dark green GRs', 'shorter median TFF', 'duration of PN', 'TFF and duration of PN', 'Bile acid content']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C3494262', 'cui_str': 'Extremely Premature Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]","[{'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1532579', 'cui_str': 'mL/kg/day'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0030232', 'cui_str': 'Pale complexion'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",,0.272969,"Overall, SiMPro infants had shorter median TFF (10 vs. 14 days,  p  = 0.02) and duration of PN (10 vs. 16 days,  p  = 0.022) compared with control group infants.","[{'ForeName': 'Athalye-Jape', 'Initials': 'AJ', 'LastName': 'Gayatri', 'Affiliation': 'Neonatal Directorate, King Edward Memorial Hospital, Perth 6008, Western Australia, Australia.'}, {'ForeName': 'Nettleton', 'Initials': 'N', 'LastName': 'Megan', 'Affiliation': 'Neonatal Directorate, King Edward Memorial Hospital, Perth 6008, Western Australia, Australia.'}, {'ForeName': 'Lai', 'Initials': 'L', 'LastName': 'Ching-Tat', 'Affiliation': 'School of Molecular Sciences, University of Western Australia, Perth 6009, Western Australia, Australia.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Elizabeth', 'Affiliation': 'Department of Biostatistics, Women and Infants Research Foundation, Perth 6008, Western Australia, Australia.'}, {'ForeName': 'Geddes', 'Initials': 'G', 'LastName': 'Donna', 'Affiliation': 'School of Molecular Sciences, University of Western Australia, Perth 6009, Western Australia, Australia.'}, {'ForeName': 'Simmer', 'Initials': 'S', 'LastName': 'Karen', 'Affiliation': 'Neonatal Directorate, King Edward Memorial Hospital, Perth 6008, Western Australia, Australia.'}, {'ForeName': 'Patole', 'Initials': 'P', 'LastName': 'Sanjay', 'Affiliation': 'Neonatal Directorate, King Edward Memorial Hospital, Perth 6008, Western Australia, Australia.'}]",Nutrients,['10.3390/nu12092585']
1472,32859032,The Low Glutamate Diet Effectively Improves Pain and Other Symptoms of Gulf War Illness.,"Gulf War Illness (GWI) is a multisymptom disorder including widespread chronic pain, fatigue and gastrointestinal problems. The objective of this study was to examine the low glutamate diet as a treatment for GWI. Forty veterans with GWI were recruited from across the US. Outcomes included symptom score, myalgic score, tender point count, dolorimetry and the Chalder Fatigue Scale. Subjects were randomized to the low glutamate diet or a wait-listed control group, with symptom score being compared after one month. Subjects then went onto a double-blind, placebo-controlled crossover challenge with monosodium glutamate (MSG)/placebo to test for return of symptoms. Symptom score was compared between diet intervention and wait-listed controls with an independent t-test and effect size was calculated with Cohen's  d . Change scores were analyzed with Wilcoxon Signed Rank tests. Crossover challenge results were analyzed with General Linear Models and cluster analysis. The diet intervention group reported significantly less symptoms ( p  = 0.0009) than wait-listed controls, with a very large effect size,  d  = 1.16. Significant improvements in average dolorimetry ( p  = 0.0006), symptom score, tender point number, myalgic score and the Chalder Fatigue Scale (all  p  < 0.0001) were observed after the 1-month diet. Challenge with MSG/placebo resulted in significant variability in individual response. These results suggest that the low glutamate diet can effectively reduce overall symptoms, pain and fatigue in GWI, but differential results upon challenge suggest that other aspects of the diet, or underlying differences within the population, may be driving these changes. Future research is needed to identify potential nutrient effects, biomarkers, and underlying metabolic differences between responders and non-responders.",2020,"Significant improvements in average dolorimetry ( p  = 0.0006), symptom score, tender point number, myalgic score and the Chalder Fatigue Scale (all  p  < 0.0001) were observed after the 1-month diet.",['Forty veterans with GWI'],"['low glutamate diet or a wait-listed control', 'placebo', 'MSG/placebo', 'monosodium glutamate (MSG)/placebo']","['individual response', 'overall symptoms, pain and fatigue in GWI', 'symptom score, tender point number, myalgic score and the Chalder Fatigue Scale', 'average dolorimetry', 'symptom score, myalgic score, tender point count, dolorimetry and the Chalder Fatigue Scale', 'symptoms', 'Symptom score']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1449761', 'cui_str': 'Persian Gulf War, 1991'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037511', 'cui_str': 'Monosodium glutamate'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1449761', 'cui_str': 'Persian Gulf War, 1991'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1562820', 'cui_str': 'Tender point'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",40.0,0.0335282,"Significant improvements in average dolorimetry ( p  = 0.0006), symptom score, tender point number, myalgic score and the Chalder Fatigue Scale (all  p  < 0.0001) were observed after the 1-month diet.","[{'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Holton', 'Affiliation': 'Department of Health Studies, American University, Washington, DC 20016, USA.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Kirkland', 'Affiliation': 'Program in Behavior, Cognition and Neuroscience, American University, Washington, DC 20016, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baron', 'Affiliation': 'Department of Mathematics & Statistics, American University, Washington, DC 20016, USA.'}, {'ForeName': 'Shalini S', 'Initials': 'SS', 'LastName': 'Ramachandra', 'Affiliation': 'Department of Health Studies, American University, Washington, DC 20016, USA.'}, {'ForeName': 'Mackenzie T', 'Initials': 'MT', 'LastName': 'Langan', 'Affiliation': 'Neuroscience Program, Department of Biology, American University, Washington, DC 20016, USA.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Brandley', 'Affiliation': 'Department of Health Studies, American University, Washington, DC 20016, USA.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Baraniuk', 'Affiliation': 'Department of Medicine, Georgetown University, Washington, DC 20057, USA.'}]",Nutrients,['10.3390/nu12092593']
1473,32846328,Factors associated with discontinuation in the drug and placebo groups of trials of second generation antipsychotics for acute schizophrenia: A meta-regression analysis: Discontinuation in antipsychotic trials.,"This study investigated factors associated with discontinuation in double-blind, randomized, placebo-controlled trials (DBRPCTs) of second-generation antipsychotics (SGAs) for acute schizophrenia, with a view to establishing what factors were associated with all-cause discontinuation. 77 eligible studies (96 comparisons; n = 22,678) were included in this study. Thirty-one factors potentially affecting all-cause discontinuation, related to the participants, study design, and drugs, were included in a meta-regression analysis that examined the factors associated with discontinuation rates in treatment and placebo groups and/or the treatment-placebo group difference in discontinuation. Smaller improvements in Positive and Negative Syndrome Scale total scores from baseline to endpoint were associated with higher discontinuation rates in both the treatment and placebo groups, and smaller response rates in the treatment group were associated with higher discontinuation rates in the treatment group. These factors were also associated with the treatment-placebo group difference in discontinuation. Although the risk of weight gain from SGA use was not associated with discontinuation rates in either the treatment or placebo groups, SGAs with a risk of weight gain were associated with a larger treatment-placebo group difference in discontinuation, although the reason is unknown. Factors associated with discontinuation rates in both treatment and placebo groups did not influence the treatment-placebo group difference in discontinuation. The efficacy and the risk of weight gain of SGAs seemed to influence treatment-placebo group difference in discontinuation in DBRPCTs of SGAs for acute schizophrenia.",2020,"Smaller improvements in Positive and Negative Syndrome Scale total scores from baseline to endpoint were associated with higher discontinuation rates in both the treatment and placebo groups, and smaller response rates in the treatment group were associated with higher discontinuation rates in the treatment group.","['acute schizophrenia', '77 eligible studies (96 comparisons; n\xa0=\xa022,678']","['placebo', 'placebo-controlled trials (DBRPCTs) of second-generation antipsychotics (SGAs']","['Positive and Negative Syndrome Scale total scores', 'discontinuation rates', 'smaller response rates', 'weight gain']","[{'cui': 'C0857501', 'cui_str': 'Acute schizophrenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",22678.0,0.223392,"Smaller improvements in Positive and Negative Syndrome Scale total scores from baseline to endpoint were associated with higher discontinuation rates in both the treatment and placebo groups, and smaller response rates in the treatment group were associated with higher discontinuation rates in the treatment group.","[{'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Kishi', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan. Electronic address: tarok@fujita-hu.ac.jp.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Department of Psychiatry, Jikei University School of Medicine, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sakuma', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Okuya', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan.'}, {'ForeName': 'Nakao', 'Initials': 'N', 'LastName': 'Iwata', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.08.003']
1474,32846388,A Randomised Controlled Trial Examining the Effects of Self-Compassion Meditations on Women's Body Image.,"Although research has suggested that body image improves following self-compassion meditation training, studies have been limited due to the use of a wait-list control group. This study therefore compared the effects of self-compassion meditations to an active control group. Seventy young adult women (17-35 years) were randomly assigned to receive either self-compassion or nature-focused guided imagery meditations. Over one week, participants engaged in two meditations and completed pre- and post-test measures of trait self-compassion, body appreciation, body shame, and appearance-contingent self-worth. A mixed design analysis of variance revealed a main effect of time; women in both meditation groups demonstrated significant increases in self-compassion and body appreciation, and significant reductions in body shame. No effect was found for appearance-contingent self-worth. There were no interactions or main effects for group. Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations. Common elements between self-compassion and guided imagery may be a mechanism for improving body image. However, further research is warranted to isolate the effects of these meditations from other specific and non-specific treatment effects. (This study was pre-registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001814268).",2020,"Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations.","['Seventy young adult women (17-35 years', ""Women's Body Image""]","['Self-Compassion Meditations', 'self-compassion or nature-focused guided imagery meditations']","['self-compassion and body appreciation', 'body shame', 'trait self-compassion, body appreciation, body shame, and appearance-contingent self-worth']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",70.0,0.0359798,"Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations.","[{'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'de Wet', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: a_d088@student.usc.edu.au.'}, {'ForeName': 'Ben R', 'Initials': 'BR', 'LastName': 'Lane', 'Affiliation': 'Centre for Human Factors and Sociotechnical Systems, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: blane@usc.edu.au.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Mulgrew', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: kmulgrew@usc.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.07.009']
1475,32853900,Effects of a mindfulness-based childbirth and parenting program on maternal-fetal attachment: A randomized controlled trial among Iranian pregnant women.,"BACKGROUND AND PURPOSE


Although mindfulness-based childbirth and parenting is suggested to promote maternal-fetal attachment, no study has yet addressed its potential effects. This study aimed to determine the effects of a mindfulness-based childbirth and parenting program on maternal-fetal attachment among Iranian pregnant women.
MATERIALS AND METHODS


This study was conducted on pregnant women, who were divided into two groups to either receive routine care plus mindfulness training for childbirth and parenting (i.e., eight 2-h group sessions once a week and one 3-h session of silent meditation) or receive routine care alone. Maternal-fetal attachment was evaluated by the Cranley's Maternal-Fetal Attachment Scale.
RESULTS


After the intervention, the total score of maternal-fetal attachment was significantly higher in the experimental group (P < 0.001; effect size = 0.640). In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
CONCLUSION


The implemented program in this study was potentially effective in promoting maternal-fetal attachment.",2020,"In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
","['pregnant women', 'Iranian pregnant women']","['routine care plus mindfulness training', 'routine care alone', 'mindfulness-based childbirth and parenting program']","['dimension of ""attributing characteristics to the fetus"" improved', 'total score of maternal-fetal attachment', 'dimension of ""differentiation of self from the fetus', 'Maternal-fetal attachment', 'maternal-fetal attachment', ""Cranley's Maternal-Fetal Attachment Scale""]","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0224299,"In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Gheibi', 'Affiliation': 'Student Research Committee, Department of Midwifery, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Zeinab_gheibi@yahoo.com.'}, {'ForeName': 'Zabihollah', 'Initials': 'Z', 'LastName': 'Abbaspour', 'Affiliation': 'Department of Psychology, School of Education and Psychology, Shahid Chamran University of Ahvaz, Ahvaz, Iran. Electronic address: Zabbaspour1356@gmail.com.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Haghighyzadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Haghighy-mh@ajums.ac.ir.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Javadifar', 'Affiliation': 'Reproductive Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Javadifar-n@ajums.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101226']
1476,32853919,Validation of sleep stage classification using non-contact radar technology and machine learning (Somnofy®).,"OBJECTIVE


To validate automatic sleep stage classification using deep neural networks on sleep assessed by radar technology in the commercially available sleep assistant Somnofy® against polysomnography (PSG).
METHODS


Seventy-one nights of overnight sleep in healthy individuals were assessed by both PSG and Somnofy at two different institutions. The Somnofy unit was placed in two different locations per room (nightstand and wall). The sleep algorithm was validated against PSG using a 25-fold cross validation technique, and performance was compared to the inter-rater reliability between the PSG sleep scored by two independent sleep specialists.
RESULTS


Epoch-by-epoch analyses showed a sensitivity (accuracy to detect sleep) and specificity (accuracy to detect wake) for Somnofy of 0.97 and 0.72 respectively, compared to 0.99 and 0.85 for the PSG scorers. The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96. The intraclass correlation coefficient revealed excellent and good reliability for total sleep time and sleep efficiency, while sleep onset and R latency had poor agreement. Somnofy underestimated total wake time by 5 min and N1/N2 by 3 min. N3 was overestimated by 4 min and R by 3 min. Results were independent of institution and sensor location.
CONCLUSION


Somnofy showed a high accuracy staging sleep in healthy individuals and has potential to assess sleep quality and quantity in a sample of healthy, mostly young adults. More research is needed to examine performance in children, older individuals and those with sleep disorders.",2020,"The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96.","['children, older individuals and those with sleep disorders', 'Seventy-one nights of overnight sleep in healthy individuals were assessed by both PSG and Somnofy at two different institutions', 'healthy individuals']",['non-contact radar technology and machine learning (Somnofy®'],"['sleep stage differentiation', 'total wake time', 'accuracy staging sleep', 'total sleep time and sleep efficiency', 'sensitivity (accuracy to detect sleep) and specificity (accuracy to detect wake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0034513', 'cui_str': 'Radar'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",,0.0201471,"The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96.","[{'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Toften', 'Affiliation': 'Department of Data Science, VitalThings AS, Tønsberg, Norway. Electronic address: st@vitalthings.com.'}, {'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Pallesen', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway; Norwegian Competence Center for Sleep Disorders, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hrozanova', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Centre of Elite Sport Research, NTNU, Trondheim, Norway.'}, {'ForeName': 'Frode', 'Initials': 'F', 'LastName': 'Moen', 'Affiliation': 'Department of Education and Lifelong Learning, Centre of Elite Sport Research, NTNU, Trondheim, Norway.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Grønli', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.022']
1477,32854000,Abstinence-reinforcing contingency management improves HIV viral load suppression among HIV-infected people who use drugs: A randomized controlled trial.,"BACKGROUND


HIV-infected people who use drugs (PWUD) have poor HIV outcomes. Few studies tested interventions to improve HIV outcomes among PWUD. Abstinence-reinforcing contingency management (CM) reduces drug use and could also improve HIV outcomes.
METHODS


From 2012-2017, we conducted a randomized controlled trial testing whether a 16-week abstinence-reinforcing CM intervention improved HIV viral load (VL) among HIV-infected adults using opioids or cocaine. In the CM intervention, drug-free urines led to escalating value of vouchers ($2.50-$80/voucher, $1320 total maximum). In intention-to-treat mixed-effects linear and logistic regression analyses, we examined whether the CM intervention improved log 10  VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes).
RESULTS


Thirty-seven participants were randomized to the CM intervention and 36 to control. Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6%). In CM (vs. control) participants, mean reduction in log 10  VL was greater (-0.16 log 10  VL copies/mL per 4-week period; 95% CI: -0.29 to -0.03, p < 0.05). Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants. The CM intervention was not significantly associated with abstinence or adherence.
CONCLUSIONS


This is the first study to demonstrate improvements in HIV VL via an abstinence-reinforcing CM intervention. Because the CM intervention did not significantly affect abstinence or adherence, the mechanism of its effect is unclear. To end the HIV epidemic, innovative strategies must address individuals with poor HIV outcomes. Abstinence-reinforcing CM may be one potential strategy to improve HIV outcomes among a select group of PWUD.",2020,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants.","['From 2012-2017', 'HIV-infected people who use drugs', 'Thirty-seven participants', 'HIV-infected adults using', 'Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6']","['opioids or cocaine', 'Abstinence-reinforcing contingency management (CM', 'CM intervention', 'abstinence-reinforcing CM intervention', 'Abstinence-reinforcing contingency management']","['mean reduction in log 10  VL', 'log 10  VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes', 'HIV viral load suppression', 'HIV outcomes', 'HIV viral load (VL', 'abstinence or adherence']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",37.0,0.178726,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants.","[{'ForeName': 'Chinazo O', 'Initials': 'CO', 'LastName': 'Cunningham', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States. Electronic address: ccunning@montefiore.org.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Arnsten', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Chenshu', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Clemson University College of Behavioral, Social and Health Sciences, Department of Public Health Sciences, Clemson Nursing Building, 605 Grove Road, Greenville, SC 29605, United States.'}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Bachhuber', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Lousiana State University Health Sciences Center-New Orleans, Section of Community and Population Medicine, Department of Medicine, 533 Bolivar St, New Orleans, LA 70112, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Jost', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grossberg', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Stein', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Sohler', 'Affiliation': 'City University of New York, School of Medicine, 160 Convent Ave, New York, NY 10031, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108230']
1478,32854052,Does symptom severity matter in stepped and collaborative care for depression?,"BACKGROUND


We investigated the differential effectiveness of a stepped and collaborative care model (SCM) vs. treatment as usual (TAU) for primary care patients with various depression severity degrees and explored whether subgroups received distinct evidence-based treatments.
METHODS


Subgroup analyses of a RCT were calculated applying a multiple linear mixed model with the factors 1. group (SCM; TAU), 2. severity ((mild-moderate (MMD); severe depression (SD)) and their interaction, with PHQ-9 as primary outcome. Utilization of treatments was analyzed descriptively.
RESULTS


For the 737 participating patients (SCM: n = 569; TAU: n = 168), availability of data substantially varies between subgroups at 12-month follow-up ranging between 37% and 70%. ITT-analysis (Last-observation-carried-forward) revealed a significant interaction for group x severity [p = 0.036] and a significant difference between groups in symptom reduction for MMD (-3.9; [95% CI: -5.1 to -2.6, p < 0.001; d = 0.64] but not for SD (-1.6; [95% CI: -3.4 to 0.2, p = 0.093; d = 0.27]. Sensitivity analyses (multiple imputation, completer analysis, pattern mixture model) didn`t confirm the interaction effect and showed significant effects for both severity groups with slightly higher effect sizes for MMD. Differences between SCM and TAU in the percentage of patients utilizing depression-specific treatments are larger for MMD.
LIMITATIONS


There was a high proportion of missing values among severely depressed patients, especially in SCM.
CONCLUSION


SCM is effective for both MMD and SD. Utilization patterns might help explain the higher effects for MMD. Various strategies of replacement of missing values lead to slightly divergent results due to selective drop out between severity groups.",2020,"Sensitivity analyses (multiple imputation, completer analysis, pattern mixture model) didn`t confirm the interaction effect and showed significant effects for both severity groups with slightly higher effect sizes for MMD.","['primary care patients with various depression severity degrees and explored whether subgroups received distinct evidence-based treatments', '737 participating patients (SCM: n\xa0=\xa0569; TAU: n\xa0=\xa0168), availability of data substantially varies between subgroups at 12-month follow-up ranging between 37% and 70']","['SCM', 'SCM and TAU', 'stepped and collaborative care model (SCM) vs. treatment as usual (TAU']",['severity ((mild-moderate (MMD); severe depression (SD'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1740791', 'cui_str': 'Evidence based treatment'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}]",737.0,0.0676647,"Sensitivity analyses (multiple imputation, completer analysis, pattern mixture model) didn`t confirm the interaction effect and showed significant effects for both severity groups with slightly higher effect sizes for MMD.","[{'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Watzke', 'Affiliation': 'Clinical Psychology and Psychotherapy Research, Institute of Psychology, University of Zurich, Binzmühlestrasse 14/16, CH-8050 Zurich, Switzerland. Electronic address: birgit.watzke@uzh.ch.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Heddaeus', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: d.heddaeus@uke.de.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Steinmann', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: m.steinmann@uke.de.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Daubmann', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: a.daubmann@uke.de.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: k.wegscheider@uke.uni-hamburg.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: m.haerter@uke.de.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.079']
1479,32858393,Reducing fall risk for home care workers with slip resistant winter footwear.,"Falls on icy surfaces are the leading cause of occupational injuries for workers exposed to outdoor winter conditions. Slip resistant footwear has been shown to reduce the risk of falls for indoor workers but until recently, there was no accepted standard for evaluating the slip resistance of winter footwear on icy surfaces. Our team recently developed a lab-based testing protocol for measuring footwear slip resistance. This protocol, called the Maximum Achievable Angle (MAA) test, measures the steepest ice-covered slope that participants can walk up and down without experiencing a slip in a simulated winter environment. This lab-based protocol has found there is wide variability in the performance of commercially available winter footwear. In particular, we have found that a new generation of footwear that incorporates composite materials in the outsole, performs much better than most other footwear. The objective of this project was to investigate whether the footwear that performed well in our lab-based testing would reduce the risk of slips and/or falls in real-world winter conditions. One hundred and ten home healthcare workers from SE Health were recruited for this study and were asked to report their exposure to icy surfaces along with the numbers of slips and numbers of falls they experienced each week using online surveys over eight weeks in the winter. Fifty participants (the intervention group) were provided winter footwear that were among the best performing in the MAA test. The remaining sixty participants (the control group) wore their own footwear for the duration of the study. A total of 563 slips and 36 falls were reported over the eight-week data collection period. The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group. We found the slip rate in the intervention group was between 68.0% and 68.7% lower than the control group. Similarly, the fall rate was between 78.5% and 81.5% lower in the intervention group compared to the control group. These findings demonstrate that footwear that performs well in the MAA test can reduce the risk of both slips and falls in real-world winter conditions.",2020,The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group.,"['Fifty participants (the intervention group) were provided winter footwear that were among the best performing in the MAA test', 'One hundred and ten home healthcare workers from SE Health', 'home care workers with slip resistant winter footwear']",[],"['fall rate', 'slip rate']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]",[],"[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}]",563.0,0.0200659,The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group.,"[{'ForeName': 'Z Shaghayegh', 'Initials': 'ZS', 'LastName': 'Bagheri', 'Affiliation': 'Department of Mechanical Engineering, George Mason University, 4400 University Dr, Fairfax, VA, 22030, USA; Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada. Electronic address: sbagheri@gmu.edu.'}, {'ForeName': 'Jose Diaz', 'Initials': 'JD', 'LastName': 'Beltran', 'Affiliation': 'Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Holyoke', 'Affiliation': 'Saint Elizabeth Health Care, 90 Allstate Parkway, Suite 300, Markham, Ontario, L3R 5H3, Canada.'}, {'ForeName': 'Tilak', 'Initials': 'T', 'LastName': 'Dutta', 'Affiliation': 'Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada; Institute of Biomedical Engineering, University of Toronto, 164 College St., Toronto, M5S3G9, Canada.'}]",Applied ergonomics,['10.1016/j.apergo.2020.103230']
1480,32859608,"Cardiovascular effects of biological versus conventional synthetic disease-modifying antirheumatic drug therapy in treatment-naïve, early rheumatoid arthritis.","OBJECTIVES


To determine whether patients with early rheumatoid arthritis (ERA) have cardiovascular disease (CVD) that is modifiable with disease-modifying antirheumatic drug (DMARD) therapy, comparing first-line etanercept (ETN) + methotrexate (MTX) with MTX strategy.
METHODS


Patients from a phase IV ERA trial randomised to ETN+MTX or MTX strategy±month 6 escalation to ETN+MTX, and with no CVD and maximum one traditional risk factor underwent cardiovascular magnetic resonance (CMR) at baseline, years 1 and 2. Thirty matched controls underwent CMR. Primary outcome measure was aortic distensibility (AD) between controls and ERA, and baseline to year 1 AD change in ERA. Secondary analyses between and within ERA groups performed. Additional outcome measures included left ventricular (LV) mass and myocardial extracellular volume (ECV).
RESULTS


Eighty-one patients recruited. In ERA versus controls, respectively, baseline (geometric mean, 95% CI) AD was significantly lower (3.0×10 -3  mm Hg -1  (2.7-3.3) vs 4.4×10 -3  mm Hg -1  (3.7-5.2), p<0.001); LV mass significantly lower (78.2 g (74.0-82.7), n=81 vs 92.9 g (84.8-101.7), n=30, p<0.01); and ECV increased (27.1% (26.4-27.9), n=78 vs 24.9% (23.8-26.1), n=30, p<0.01). Across all patients, AD improved significantly from baseline to year 1 (3.0×10 -3  mm Hg -1  (2.7-3.4) to 3.6×10 -3  mm Hg -1  (3.1-4.1), respectively, p<0.01), maintained at year 2. The improvement in AD did not differ between the two treatment arms and disease activity state (Disease Activity Score with 28 joint count)-erythrocyte sedimentation rate-defined responders versus non-responders.
CONCLUSION


We report the first evidence of vascular and myocardial abnormalities in an ERA randomised controlled trial cohort and show improvement with DMARD therapy. The type of DMARD (first-line tumour necrosis factor-inhibitors or MTX) and clinical response to therapy did not affect CVD markers.
TRIAL REGISTRATION NUMBER


ISRCTN: ISRCTN89222125; ClinicalTrials.gov: NCT01295151.",2020,"The improvement in AD did not differ between the two treatment arms and disease activity state (Disease Activity Score with 28 joint count)-erythrocyte sedimentation rate-defined responders versus non-responders.
","['Patients from a phase IV ERA trial randomised to', 'patients with early rheumatoid arthritis (ERA', 'Eighty-one patients recruited']","['DMARD therapy', 'CMR', 'etanercept (ETN) + methotrexate (MTX) with MTX strategy', 'biological versus conventional synthetic disease-modifying antirheumatic drug therapy', 'ETN+MTX or MTX strategy±month 6 escalation to ETN+MTX, and with no CVD and maximum one traditional risk factor underwent cardiovascular magnetic resonance (CMR']","['ECV', 'LV mass', 'disease activity state (Disease Activity Score', 'left ventricular (LV) mass and myocardial extracellular volume (ECV', 'aortic distensibility (AD) between controls and ERA, and baseline to year 1 AD change in ERA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517884', 'cui_str': '81'}]","[{'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",81.0,0.40753,"The improvement in AD did not differ between the two treatment arms and disease activity state (Disease Activity Score with 28 joint count)-erythrocyte sedimentation rate-defined responders versus non-responders.
","[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Plein', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Bara', 'Initials': 'B', 'LastName': 'Erhayiem', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Fent', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Horton', 'Affiliation': 'Central Lancashire Moving Well Service, Lancashire and South Cumbria NHS Foundation Trust, Lancashire, UK.'}, {'ForeName': 'Raluca Bianca', 'Initials': 'RB', 'LastName': 'Dumitru', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Andrews', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Elizabeth Ma', 'Initials': 'EM', 'LastName': 'Hensor', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Baxter', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Pavitt', 'Affiliation': 'Dental Translational and Clinical Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'Maya H', 'Initials': 'MH', 'LastName': 'Buch', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK maya.buch@manchester.ac.uk.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217653']
1481,32865576,Effectiveness of a Digital Cognitive Behavior Therapy-Guided Self-Help Intervention for Eating Disorders in College Women: A Cluster Randomized Clinical Trial.,"Importance


Eating disorders (EDs) are common, serious psychiatric disorders on college campuses, yet most affected individuals do not receive treatment. Digital interventions have the potential to bridge this gap.
Objective


To determine whether a coached, digital, cognitive behavior therapy (CBT) intervention improves outcomes for college women with EDs compared with referral to usual care.
Design, Setting, and Participants


This cluster randomized trial was conducted from 2014 to 2018 at 27 US universities. Women with binge-purge EDs (with both threshold and subthreshold presentations) were recruited from enrolled universities. The 690 participants were followed up for up to 2 years after the intervention. Data analysis was performed from February to September 2019.
Interventions


Universities were randomized to the intervention, Student Bodies-Eating Disorders, a digital CBT-guided self-help program, or to referral to usual care.
Main Outcomes and Measures


The main outcome was change in overall ED psychopathology. Secondary outcomes were abstinence from binge eating and compensatory behaviors, as well as ED behavior frequencies, depression, anxiety, clinical impairment, academic impairment, and realized treatment access.
Results


A total of 690 women with EDs (mean [SD] age, 22.12 [4.85] years; 414 [60.0%] White; 120 [17.4%] Hispanic; 512 [74.2%] undergraduates) were included in the analyses. For ED psychopathology, there was a significantly greater reduction in the intervention group compared with the control group at the postintervention assessment (β [SE], -0.44 [0.10]; d = -0.40; t1387 = -4.23; P < .001), as well as over the follow-up period (β [SE], -0.39 [0.12]; d = -0.35; t1387 = -3.30; P < .001). There was not a significant difference in abstinence from any ED behaviors at the postintervention assessment (odds ratio, 1.48; 95% CI, 0.48-4.62; P = .50) or at follow-up (odds ratio, 1.51; 95% CI, 0.63-3.58; P = .36). Compared with the control group, the intervention group had significantly greater reductions in binge eating (rate ratio, 0.82; 95% CI, 0.70-0.96; P = .02), compensatory behaviors (rate ratio, 0.68; 95% CI, 0.54-0.86; P < .001), depression (β [SE], -1.34 [0.53]; d = -0.22; t1387 = -2.52; P = .01), and clinical impairment (β [SE], -2.33 [0.94]; d = -0.21; t1387 = -2.49; P = .01) at the postintervention assessment, with these gains sustained through follow-up for all outcomes except binge eating. Groups did not differ in terms of academic impairment. The majority of intervention participants (318 of 385 participants [83%]) began the intervention, whereas only 28% of control participants (76 of 271 participants with follow-up data available) sought treatment for their ED (odds ratio, 12.36; 95% CI, 8.73-17.51; P < .001).
Conclusions and Relevance


In this cluster randomized clinical trial comparing a coached, digital CBT intervention with referral to usual care, the intervention was effective in reducing ED psychopathology, compensatory behaviors, depression, and clinical impairment through long-term follow-up, as well as realizing treatment access. No difference was found between the intervention and control groups for abstinence for all ED behaviors or academic impairment. Given its scalability, a coached, digital, CBT intervention for college women with EDs has the potential to address the wide treatment gap for these disorders.
Trial Registration


ClinicalTrials.gov Identifier: NCT02076464.",2020,"For ED psychopathology, there was a significantly greater reduction in the intervention group compared with the control group at the postintervention assessment (β [SE], -0.44 [0.10];","['Eating Disorders in College Women', '690 participants were followed up for up to 2 years after the intervention', '690 women with EDs (mean [SD] age', 'Hispanic; 512 [74.2%] undergraduates) were included in the analyses', 'Women with binge-purge EDs (with both threshold and subthreshold presentations) were recruited from enrolled universities', 'college women with EDs compared with referral to usual care', '2014 to 2018 at 27 US universities', 'college women with EDs']","['digital CBT intervention', 'digital CBT-guided self-help program, or to referral to usual care', 'Digital Cognitive Behavior Therapy-Guided Self-Help Intervention', 'coached, digital, cognitive behavior therapy (CBT) intervention']","['abstinence from binge eating and compensatory behaviors, as well as ED behavior frequencies, depression, anxiety, clinical impairment, academic impairment, and realized treatment access', 'binge eating', 'academic impairment', 'overall ED psychopathology', 'compensatory behaviors', 'abstinence from any ED behaviors', 'ED psychopathology, compensatory behaviors, depression, and clinical impairment']","[{'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0855227', 'cui_str': 'Purging'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",690.0,0.142186,"For ED psychopathology, there was a significantly greater reduction in the intervention group compared with the control group at the postintervention assessment (β [SE], -0.44 [0.10];","[{'ForeName': 'Ellen E', 'Initials': 'EE', 'LastName': 'Fitzsimmons-Craft', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'C Barr', 'Initials': 'CB', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Graham', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Shiri', 'Initials': 'S', 'LastName': 'Sadeh-Sharvit', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Katherine N', 'Initials': 'KN', 'LastName': 'Balantekin', 'Affiliation': 'Department of Exercise and Nutrition Sciences, University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Eichen', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, San Diego.'}, {'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Monterubio', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Neha J', 'Initials': 'NJ', 'LastName': 'Goel', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Rachael E', 'Initials': 'RE', 'LastName': 'Flatt', 'Affiliation': 'Department of Psychology and Neurosciences, University of North Carolina at Chapel Hill, Chapel Hill.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Karam', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Firebaugh', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Jacobi', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität, Dresden, Germany.'}, {'ForeName': 'Booil', 'Initials': 'B', 'LastName': 'Jo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Mickey T', 'Initials': 'MT', 'LastName': 'Trockel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Wilfley', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.15633']
1482,32861983,Can 'floating' predict treatment response to ketamine? Data from three randomized trials of individuals with treatment-resistant depression.,"Ketamine has rapid-acting antidepressant properties but also potentially concerning transient dissociative side effects (SEs). Recent studies noted a positive correlation between treatment response to ketamine and general dissociative SEs, as well as ""floating"", a depersonalization SE (a subtype of the dissociative SEs). This analysis sought to determine whether floating mediates treatment response to ketamine. Data were pooled from three double-blind, crossover, placebo-controlled ketamine clinical trials across which 82 participants with treatment-resistant depression (TRD) (44 with bipolar depression and 38 with major depressive disorder) received placebo and ketamine (0.5 mg/kg) infusions. SEs were actively solicited in a standardized fashion before and after ketamine infusion. The hypothesis that a post-infusion experience of floating would mediate antidepressant response to ketamine was assessed at 230 min post-infusion and at Day 1. Montgomery-Asberg Depression Rating Scale (MADRS) total score was the dependent variable in a linear mixed effects model. Ketamine significantly decreased MADRS scores (p < 0.0001), but no relationship was detected between floating and MADRS score at either 230 min or Day 1 post-infusion. The hypothesized mediation effect of floating was also not detected at either 230 min or Day 1 post-infusion. Taken together, the findings do not support the hypothesis that ketamine's antidepressant effects are mediated by the dissociative depersonalization subtype SE of floating.",2020,"Ketamine significantly decreased MADRS scores (p < 0.0001), but no relationship was detected between floating and MADRS score at either 230 min or Day 1 post-infusion.","['82 participants with treatment-resistant depression (TRD) (44 with bipolar depression and 38 with major depressive disorder', 'individuals with treatment-resistant depression']","['placebo and ketamine', 'ketamine', 'placebo-controlled ketamine', 'Ketamine']","['MADRS scores', 'floating and MADRS score', 'Montgomery-Asberg Depression Rating Scale (MADRS) total score']","[{'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4706358', 'cui_str': 'MADRS (Montgomery-Asberg Depression Rating Scale) score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",82.0,0.226109,"Ketamine significantly decreased MADRS scores (p < 0.0001), but no relationship was detected between floating and MADRS score at either 230 min or Day 1 post-infusion.","[{'ForeName': 'Elia E', 'Initials': 'EE', 'LastName': 'Acevedo-Diaz', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. Electronic address: elia.acevedo@gmail.com.'}, {'ForeName': 'Grace W', 'Initials': 'GW', 'LastName': 'Cavanaugh', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Dede', 'Initials': 'D', 'LastName': 'Greenstein', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.06.012']
1483,32863014,[Effect of acupuncture on the prevention of nausea and vomiting after laparoscopic cholecystectomy: a randomized clinical trial].,"BACKGROUND AND OBJECTIVES


Postoperative nausea and vomiting (PONV) is a common and undesirable complication observed after laparoscopic cholecystectomy (LC). We investigated the effects of auriculoacupuncture (AA) on the prevention of postoperative nausea and vomiting in the immediate postoperative period of uncomplicated laparoscopic cholecystectomy.
METHODS


Sixty-eight patients were randomly divided into two groups, auriculoacupuncture (n = 35) and control (n = 33) and then they were evaluated prospectively. The needle was placed before anaesthesia induction and remained for 20 minutes. Nausea intensity was evaluated using an analogic visual scale and PONV events were registered immediately after anaesthesia care unit admission and in the second, fourth and sixth hours after the surgery.
RESULTS


The auriculoacupuncture group had a significantly smaller incidence of nausea and vomiting than the control group throughout the whole postoperative period (16/35 vs. 27/33, p = 0.03 and 4/35 vs. 15/33, p = 0.005, respectively); the AA group had fewer nausea events 2hours (p = 0.03) and 6hours (p = 0.001) after surgery and fewer vomiting events 2hours (p = 0.01) and 6hours (p = 0.02) after surgery.
CONCLUSIONS


Auriculoacupuncture can partially prevent postoperative nausea and vomiting when compared to metoclopramide alone after uncomplicated laparoscopic cholecystectomy. Auriculoacupuncture can be recommended as an adjuvant therapy for postoperative nausea and vomiting prevention in selected patients.",2020,"The auriculoacupuncture group had a significantly smaller incidence of nausea and vomiting than the control group throughout the whole postoperative period (16/35 vs. 27/33, p = 0.03 and 4/35 vs. 15/33, p = 0.005, respectively); the AA group had fewer nausea events 2hours (p = 0.03) and 6hours (p = 0.001) after surgery and fewer vomiting events 2hours (p = 0.01) and 6hours (p = 0.02) after surgery.
","['Sixty-eight patients', 'n = 35) and control (n = 33) and then they were evaluated prospectively']","['laparoscopic cholecystectomy', 'Auriculoacupuncture', 'auriculoacupuncture (AA', 'acupuncture', 'metoclopramide', 'laparoscopic cholecystectomy (LC', 'auriculoacupuncture']","['vomiting events', 'postoperative nausea and vomiting', 'nausea and vomiting', 'analogic visual scale and PONV events', 'Nausea intensity', 'nausea events']","[{'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}]","[{'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",68.0,0.0365912,"The auriculoacupuncture group had a significantly smaller incidence of nausea and vomiting than the control group throughout the whole postoperative period (16/35 vs. 27/33, p = 0.03 and 4/35 vs. 15/33, p = 0.005, respectively); the AA group had fewer nausea events 2hours (p = 0.03) and 6hours (p = 0.001) after surgery and fewer vomiting events 2hours (p = 0.01) and 6hours (p = 0.02) after surgery.
","[{'ForeName': 'Luiz Eduardo', 'Initials': 'LE', 'LastName': 'Miranda', 'Affiliation': 'Universidade de Pernambuco (UPE), Hospital Universitário Oswaldo Cruz, Divisão de Cirurgia Geral e Transplante de Fígado, Recife, PE, Brazil. Electronic address: lecmiranda@gmail.com.'}, {'ForeName': 'Luiz de França Maia E Silva', 'Initials': 'LFMES', 'LastName': 'Filho', 'Affiliation': 'Universidade de Pernambuco (UPE), Faculdade de Ciências Médicas, Recife, PE, Brazil.'}, {'ForeName': 'Ana Carolina Brainer de', 'Initials': 'ACB', 'LastName': 'Siqueira', 'Affiliation': 'Universidade de Pernambuco (UPE), Faculdade de Ciências Médicas, Recife, PE, Brazil.'}, {'ForeName': 'Ana Clara', 'Initials': 'AC', 'LastName': 'Miranda', 'Affiliation': 'Universidade de Pernambuco (UPE), Faculdade de Ciências Médicas, Recife, PE, Brazil.'}, {'ForeName': 'Bianca Rodrigues Castelo Branco', 'Initials': 'BRCB', 'LastName': 'Rocha', 'Affiliation': 'Universidade de Pernambuco (UPE), Faculdade de Ciências Médicas, Recife, PE, Brazil.'}, {'ForeName': 'Ian Victor Paiva de', 'Initials': 'IVP', 'LastName': 'Lima', 'Affiliation': 'Universidade de Pernambuco (UPE), Faculdade de Ciências Médicas, Recife, PE, Brazil.'}, {'ForeName': 'Victor Soares Gomes da', 'Initials': 'VSGD', 'LastName': 'Silva', 'Affiliation': 'Universidade de Pernambuco (UPE), Faculdade de Ciências Médicas, Recife, PE, Brazil.'}, {'ForeName': 'Diego Laurentino de', 'Initials': 'DL', 'LastName': 'Lima', 'Affiliation': 'Universidade de Pernambuco (UPE), Hospital Universitário Oswaldo Cruz, Divisão de Cirurgia Geral e Transplante de Fígado, Programa de Pós-Graduação de Medicina, Recife, PE, Brazil.'}, {'ForeName': 'Holmes', 'Initials': 'H', 'LastName': 'Naspollini', 'Affiliation': 'Universidade de Pernambuco (UPE), Hospital Universitário Oswaldo Cruz, Divisão de Cirurgia Geral e Transplante de Fígado, Recife, PE, Brazil.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2019.08.001']
1484,32867199,Omega-3 Polyunsaturated Fatty Acids EPA and DHA as an Adjunct to Non-Surgical Treatment of Periodontitis: A Randomized Clinical Trial.,"Periodontitis is a chronic multifactorial inflammatory disease that leads to the loss of supportive tissues around the teeth with gradual deterioration of masticatory function and esthetics, resulting eventually in the decrease of the life quality. Host immune response triggered by bacterial biofilm is responsible for the chronic periodontal inflammation and ongoing tissue loss. Omega-3 polyunsaturated fatty acids (PUFA) such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have anti-inflammatory properties, thus may be used for the treatment of chronic inflammatory diseases. In this study, we aimed to evaluate the effect of dietary supplementation with omega-3 PUFA in the patients with stage III and IV periodontitis. Thirty otherwise healthy patients were treated with scaling and root planning (SRP). In the test group ( n  = 16), patients were additionally supplemented with 2.6 g of EPA and 1.8 g of DHA. In the control group ( n  = 14), patients received only SRP. Periodontal examination was performed at baseline and three months following initial therapy. Salivary samples were taken twice at baseline and at the end of the experiment. We found that there was a statistically significant reduction in the bleeding on probing (BOP) and improvement of clinical attachment loss (CAL) at three months in the test group compared to the control group. Moreover, a statistically significant higher percentage of closed pockets (probing depth ≤ 4 mm without BOP) was achieved in the test group vs. control group after three months of treatment. Accordingly, the levels of pro-inflammatory cytokines/chemokines interleukin (IL)-8 and IL-17 were markedly lower, while the level of anti-inflammatory IL-10 was significantly higher in the salivary samples of the patients supplemented with omega-3 PUFA at three months in comparison to the patients treated with SRP alone. Our findings demonstrate that dietary intervention with high-dose of omega-3 PUFA during non-surgical therapy may have potential benefits in the management of periodontitis.",2020,"Moreover, a statistically significant higher percentage of closed pockets (probing depth ≤ 4 mm without BOP) was achieved in the test group vs. control group after three months of treatment.","['Periodontitis', 'Thirty otherwise healthy patients', 'patients with stage III and IV periodontitis']","['dietary supplementation with omega-3 PUFA', 'scaling and root planning (SRP', 'omega-3 PUFA', 'Omega-3 Polyunsaturated Fatty Acids EPA and DHA', 'Omega-3 polyunsaturated fatty acids (PUFA) such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA']","['level of anti-inflammatory IL-10', 'closed pockets', 'levels of pro-inflammatory cytokines/chemokines interleukin (IL)-8 and IL-17', 'bleeding on probing (BOP) and improvement of clinical attachment loss (CAL']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]",30.0,0.0340405,"Moreover, a statistically significant higher percentage of closed pockets (probing depth ≤ 4 mm without BOP) was achieved in the test group vs. control group after three months of treatment.","[{'ForeName': 'Mirella', 'Initials': 'M', 'LastName': 'Stańdo', 'Affiliation': 'Department of Periodontology and Oral Diseases, Medical University of Lodz, 90-419 Lodz, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Piatek', 'Affiliation': 'Department of Neurology, Medical University of Lodz, 90-419 Lodz, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Namiecinska', 'Affiliation': 'Department of Neurology, Medical University of Lodz, 90-419 Lodz, Poland.'}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Lewkowicz', 'Affiliation': 'Department of Neurology, Medical University of Lodz, 90-419 Lodz, Poland.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Lewkowicz', 'Affiliation': 'Department of Periodontology and Oral Diseases, Medical University of Lodz, 90-419 Lodz, Poland.'}]",Nutrients,['10.3390/nu12092614']
1485,32867282,"The Effect of Dietary Supplementation on Aggressive Behaviour in Australian Adult Male Prisoners: A Feasibility and Pilot Study for a Randomised, Double Blind Placebo Controlled Trial.","This study aimed to assess the feasibility of conducting a nutrition trial in adult male prisoners. Adult male prisoners were recruited for a 16-week randomised control trial comparing the effect of ingestion of omega-3 long chain polyunsaturated fatty acids (n-3 LCPUFA) and multivitamin supplements versus placebo on aggressive behaviour. The baseline and post-intervention assessments from the participant blood samples were the erythrocyte n-3 LCPUFA levels as well as measures of aggressive behaviour determined through institutional records of misconduct (IRM), the Inmate Behaviour Observation Scale (IBOS), and questionnaires. A total of 136 adult male prisoners consented to the study with a retention rate of 60%, and 93% of blood samples were successfully collected. The IRM and IBOS scores were collected for 100% of participants, whilst 82-97% of participants completed the questionnaires. From the baseline data, the Odds Ratio shows that prisoners are 4.3 times more likely to have an IBOS >2 if they are below the 6% cut off on the omega-3 index. Both groups improved across all outcome measures and, at the current sample size, no significant differences were seen between them. A power calculation suggests a total sample size of 600 participants is required to detect the effects of this dietary supplementation, and that this supplementation study is feasible in a Correctional Centre. Important criteria for the exclusion and consideration of logistics and compliance are presented.",2020,"Both groups improved across all outcome measures and, at the current sample size, no significant differences were seen between them.","['adult male prisoners', '600 participants', 'Adult male prisoners', 'Australian Adult Male Prisoners', '136 adult male prisoners consented to the study with a retention rate of 60%, and 93% of blood samples were successfully collected']","['Dietary Supplementation', 'Placebo', 'ingestion of omega-3 long chain polyunsaturated fatty acids (n-3 LCPUFA) and multivitamin supplements versus placebo']","['erythrocyte n-3 LCPUFA levels', 'IRM and IBOS scores', 'Aggressive Behaviour', 'aggressive behaviour determined through institutional records of misconduct (IRM), the Inmate Behaviour Observation Scale (IBOS), and questionnaires']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",136.0,0.338338,"Both groups improved across all outcome measures and, at the current sample size, no significant differences were seen between them.","[{'ForeName': 'Colin H', 'Initials': 'CH', 'LastName': 'Cortie', 'Affiliation': 'School of Medicine, Lipid Research Centre, Molecular Horizons, University of Wollongong, Wollongong, NSW 2522, Australia.'}, {'ForeName': 'Mitchell K', 'Initials': 'MK', 'LastName': 'Byrne', 'Affiliation': 'School of Psychology, University of Wollongong, Wollongong, NSW 2522, Australia.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Collier', 'Affiliation': 'South Coast Correctional Centre, Nowra, NSW 2541; Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Parletta', 'Affiliation': 'Allied Health & Human Performance, University of South Australia, Adelaide, SA 5001, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Crawford', 'Affiliation': 'South Coast Correctional Centre, Nowra, NSW 2541; Australia.'}, {'ForeName': 'Pia C', 'Initials': 'PC', 'LastName': 'Winberg', 'Affiliation': 'Venus Shell Systems and Shoalhaven Marine & Freshwater Centre, University of Wollongong, Nowra, NSW 2541, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Webster', 'Affiliation': 'School of Medicine, Lipid Research Centre, Molecular Horizons, University of Wollongong, Wollongong, NSW 2522, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Chapman', 'Affiliation': 'South Coast Correctional Centre, Nowra, NSW 2541; Australia.'}, {'ForeName': 'Gayle', 'Initials': 'G', 'LastName': 'Thomas', 'Affiliation': 'South Coast Correctional Centre, Nowra, NSW 2541; Australia.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Dally', 'Affiliation': 'South Coast Correctional Centre, Nowra, NSW 2541; Australia.'}, {'ForeName': 'Marijka', 'Initials': 'M', 'LastName': 'Batterham', 'Affiliation': 'Statistical Consulting Service, University of Wollongong, Wollongong, NSW 2522, Australia.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Martin', 'Affiliation': 'Corrective Services New South Wales, Sydney, NSW 2000, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Grant', 'Affiliation': 'Corrective Services New South Wales, Sydney, NSW 2000, Australia.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Meyer', 'Affiliation': 'School of Medicine, Lipid Research Centre, Molecular Horizons, University of Wollongong, Wollongong, NSW 2522, Australia.'}]",Nutrients,['10.3390/nu12092617']
1486,32866688,Improved neck posture and reduced neck muscle activity when using a novel camera based workstation for manual precision inspection tasks.,"PURPOSE


This study investigates the effects of the usage of a novel camera system compared to a conventional lens system for manual precision tasks. Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
METHODS


Camera and lens systems were compared by assessing the craniovertebral angle (CVA), electromyographic activity of the M.trapezius and perceived exertion. 16 healthy participants (n = 8 female, 24 ± 2 years; n = 8 male, 30 ± 5 years) performed manual precision tasks in a cross-over design using both systems in sitting and standing positions.
RESULTS


Analyses showed that using the camera system improved the CVA in sitting [28.4° (22.8°-33.9°) to 42.5° (38.9°-46.1°); p < 0.01] and decreased the M.trapezius activity in standing [13.1% (7.7%-18.6%) to 8.65% (5.49%-11.81%)]. Additionally, overall and neck specific perceived exertion decreased when using the camera system in standing.
CONCLUSIONS


The camera system may prevent neck pain in workers performing manual precision tasks in sitting and standing postures.",2020,"Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
","['16 healthy participants (n\xa0=\xa08 female, 24\xa0±\xa02 years; n\xa0=\xa08 male, 30\xa0±\xa05 years) performed']","['manual precision tasks in a cross-over design using both systems in sitting and standing positions', 'novel camera system']","['craniovertebral angle (CVA), electromyographic activity of the M.trapezius and perceived exertion', 'CVA in sitting', 'Improved neck posture and reduced neck muscle activity', 'M.trapezius activity', 'overall and neck specific perceived exertion']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0179533', 'cui_str': 'Camera'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0027532', 'cui_str': 'Skeletal muscle structure of neck'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",16.0,0.0296013,"Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Gräf', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Mattes', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Luedtke', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany; Department of Health Sciences, Academic Physiotherapy, Pain and Exercise Research Luebeck (P.E.R.L), University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Wollesen', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany; Department of Psychology and Neuroergonomics, Technical University of Berlin, Fasanenstraße 1, 10623, Berlin, Germany. Electronic address: bettina.wollesen@uni-hamburg.de.'}]",Applied ergonomics,['10.1016/j.apergo.2020.103147']
1487,32877302,"Re: The Effect of Antioxidants on Male Factor Infertility: The Males, Antioxidants, and Infertility (MOXI) Randomized Clinical Trial.",,2020,,['Male Factor Infertility'],['Antioxidants'],"['Males, Antioxidants, and Infertility (MOXI']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]",,0.275223,,"[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Niederberger', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001253.01']
1488,32877825,Psychomotor Retardation and the prognosis of antidepressant treatment in patients with unipolar Psychotic Depression.,"BACKGROUND


Psychomotor Retardation is a key symptom of Major Depressive Disorder. According to the literature its presence may affect the prognosis of treatment. Aim of the present study is to investigate the prognostic role of Psychomotor Retardation in patients with unipolar Psychotic Depression who are under antidepressant treatment.
METHODS


The Salpetriere Retardation Rating Scale was administered at baseline and after 6 weeks to 122 patients with unipolar Psychotic Depression who were randomly allocated to treatment with imipramine, venlafaxine or venlafaxine plus quetiapine. We studied the effects of Psychomotor Retardation on both depression and psychosis related outcome measures.
RESULTS


73% of the patients had Psychomotor Retardation at baseline against 35% after six weeks of treatment. The presence of Psychomotor Retardation predicted lower depression remission rates in addition to a higher persistence of delusions. After six weeks of treatment, venlafaxine was associated with higher levels of Psychomotor Retardation compared to imipramine and venlafaxine plus quetiapine.
CONCLUSIONS


Our data confirm that Psychomotor Retardation is a severity marker of unipolar Psychotic Depression. It is highly prevalent and predicts lower effectivity of antidepressant psychopharmacological treatment.",2020,"After six weeks of treatment, venlafaxine was associated with higher levels of Psychomotor Retardation compared to imipramine and venlafaxine plus quetiapine.
","['patients with unipolar Psychotic Depression', 'patients with unipolar Psychotic Depression who are under antidepressant treatment', '122 patients with unipolar Psychotic Depression']","['imipramine', 'imipramine, venlafaxine or venlafaxine plus quetiapine', 'venlafaxine']","['depression remission rates', 'Salpetriere Retardation Rating Scale', 'Psychomotor Retardation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0270458', 'cui_str': 'Severe major depression with psychotic features'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0020934', 'cui_str': 'Imipramine'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0025362', 'cui_str': 'Mental retardation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0424230', 'cui_str': 'Motor retardation'}]",122.0,0.0264904,"After six weeks of treatment, venlafaxine was associated with higher levels of Psychomotor Retardation compared to imipramine and venlafaxine plus quetiapine.
","[{'ForeName': 'Joost G E', 'Initials': 'JGE', 'LastName': 'Janzing', 'Affiliation': 'Department of Psychiatry, Department of Psychiatry, Radboudumc, Nijmegen, the Netherlands. Electronic address: Joost.Janzing@radboudumc.nl.'}, {'ForeName': 'Tom K', 'Initials': 'TK', 'LastName': 'Birkenhäger', 'Affiliation': 'Department of Psychiatry Erasmus University Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Walter W', 'Initials': 'WW', 'LastName': 'van den Broek', 'Affiliation': 'Department of Psychiatry Erasmus University Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Leonie M T', 'Initials': 'LMT', 'LastName': 'Breteler', 'Affiliation': 'Department of Psychiatry, St. Antonius-Mesos Hospital, Utrecht, the Netherlands.'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'Nolen', 'Affiliation': 'Department of Psychiatry, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'Robbert-Jan', 'Initials': 'RJ', 'LastName': 'Verkes', 'Affiliation': 'Department of Psychiatry, Department of Psychiatry, Radboudumc, Nijmegen, the Netherlands.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.020']
1489,32877859,The influence of center line width during the crossover hop test.,"OBJECTIVES


To assess the influence of center line width on crossover hop for distance test (XHOP) performance.
DESIGN


Repeated measures.
SETTING


University laboratory.
PARTICIPANTS


33 physically active females without history of a ligamentous knee injury (age: 22.5 ± 2.3 years).
MAIN OUTCOME MEASURES


Hop distance was measured during four XHOP conditions with variations in center line width: 2.54 cm (narrow), 15 cm (standard), 12.5% of the participants' height (HT1), and 25% of the participants' height (HT2). A repeated measures ANOVA was used to evaluate differences in hop distance for XHOP condition (narrow, standard, HT1, and HT2).
RESULTS


Differences in hop distance were shown on XHOP condition (p < 0.001). Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
CONCLUSIONS


No differences in hop distance were identified between narrow and standard center line width XHOP conditions in healthy females. Decreased hop distance was shown when center line width was normalized to 25% of participant height in comparison to all other XHOP conditions, with medium effect sizes. This study highlights hop distance outcomes based on different XHOP center line widths, normalizing the XHOP according to height, and potential implications for frontal plane knee loading during the XHOP in healthy individuals.",2020,"Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
","['33 physically active females without history of a ligamentous knee injury (age: 22.5\xa0±\xa02.3 years', 'healthy females', 'University laboratory', 'healthy individuals']",[],"['distance test (XHOP) performance', 'XHOP condition', 'XHOP condition (narrow, standard, HT1, and HT2']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C4517649', 'cui_str': '22.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0450565', 'cui_str': 'HT1'}, {'cui': 'C0450566', 'cui_str': 'HT2'}]",33.0,0.0332208,"Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
","[{'ForeName': 'Brandon M', 'Initials': 'BM', 'LastName': 'Ness', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA; Doctor of Physical Therapy Program, Department of Public Health and Community Medicine, Tufts University School of Medicine, 136 Harrison Ave, Boston, MA, 02111, USA. Electronic address: Brandon.Ness@tufts.edu.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Albright', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Ehlers', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Glasoe', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Selby', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Kory', 'Initials': 'K', 'LastName': 'Zimney', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kernozek', 'Affiliation': 'Department of Health Professions, Physical Therapy Program, La Crosse Institute for Movement Science, University of Wisconsin - La Crosse, 1725 State Street, La Crosse, WI, 54601, USA.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.08.005']
1490,32877884,Reduced morbidity by using LigaSure compared to conventional inguinofemoral lymphadenectomy in vulvar cancer patients: A randomized controlled trial.,"BACKGROUND


Inguinofemoral lymphadenectomy (IFL) is part of the surgical treatment of different malignancies of the genital tract and/or the lower limb including vulvar carcinoma, penile carcinoma and melanoma. IFL is associated with morbidity in up to 85% of the patients. The aims of this MAMBO-IC study (Morbidity And Measurement of the Body) are to study the feasibility of using LigaSure for IFL and to assess the differences in the incidence of short-term complications using LigaSure versus conventional IFL randomized within each individual patient.
METHODS


In this multicenter randomized controlled trial (RCT), women diagnosed with squamous cell carcinoma of the vulva with an indication for bilateral IFL were included. It was randomly assigned for which groin the LigaSure was used; the other groin was treated with conventional IFL (sharp/diathermia). We estimated the incidence of ≥1 complication(s) per groin using logistic regression and compared this between the two surgical methods, adjusting for possible confounders.
RESULTS


We included 40 groins of 20 patients. The estimated incidence of ≥1 complication(s) was 29% after LigaSure versus 70% after conventional IFL (risk difference 41% (95% CI 19-62), p < 0.001). Patients' reported restriction of daily living activities and maximum pain score were equal for both treatment methods. There were no differences in the surgeon reported workload scores.
CONCLUSIONS


This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL. Further studies with a larger sample size are needed to validate our findings. ISRCTN15057626.",2020,This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL.,"['40 groins of 20 patients', 'vulvar cancer patients', 'women diagnosed with squamous cell carcinoma of the vulva with an indication for bilateral IFL were included']","['conventional IFL (sharp/diathermia', 'Inguinofemoral lymphadenectomy (IFL', 'IFL', 'conventional inguinofemoral lymphadenectomy', 'LigaSure']","['restriction of daily living activities and maximum pain score', 'morbidity', 'estimated incidence of ≥1 complication(s']","[{'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0375071', 'cui_str': 'Malignant tumor of vulva'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0280856', 'cui_str': 'Squamous cell carcinoma of vulva'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.247773,This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL.,"[{'ForeName': 'Anne-Floor W', 'Initials': 'AW', 'LastName': 'Pouwer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands. Electronic address: Anne-Floor.W.Pouwer@radboudumc.nl.'}, {'ForeName': 'Henriette J', 'Initials': 'HJ', 'LastName': 'Arts', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, Department of Obstetrics and Gynaecology, the Netherlands.'}, {'ForeName': 'Corine M', 'Initials': 'CM', 'LastName': 'Koopmans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Johanna M A', 'Initials': 'JMA', 'LastName': 'Pijnenborg', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Joanne A', 'Initials': 'JA', 'LastName': 'de Hullu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.011']
1491,32886178,Pharmacokinetics and pharmacodynamics of intranasal remimazolam-a randomized controlled clinical trial.,"PURPOSE


Remimazolam is a novel and ultra-short-acting sedative currently developed for intravenous use in procedural sedation, general anesthesia, and ICU sedation. However, intravenous administration is not always appropriate, depending on the patient or setting. This study evaluated intranasal administration as a potential alternative route.
METHODS


The study used a randomized, double-blind, 9 period cross-over design to compare the pharmacokinetics, pharmacodynamics, and safety of single intranasal doses of 10, 20, and 40 mg remimazolam (as powder or solution) with intranasal placebo and 4 mg intravenous remimazolam.
RESULTS


Intranasal remimazolam powder had a consistent absolute bioavailability of approximately 50%; T max  was 10 min; AUC and C max  were dose-proportional. The higher doses of intranasal solution, however, resulted in decreasing bioavailability and loss of dose-proportionality in AUC and C max  despite complete drug absorption due to partial swallowing of dose and the resulting first-pass effect. Pharmacodynamics were generally consistent with PK. Peak effects (drowsiness, relaxation, any, memory, response time) were in similar ranges after intranasal (10 to 40 mg) as intravenous (4 mg) dosing and were partially, but not consistently, dose-related. Safety results were generally consistent with other benzodiazepines; however, intranasal remimazolam (but not placebo) caused nasal discomfort/pain, in some cases even severe.
CONCLUSIONS


Intranasal administration of remimazolam was safe and caused sedative effects. However, the severe pain and discomfort caused by intranasal remimazolam prohibit its use by this route of administration, at least with the currently available intravenous formulation.",2020,"RESULTS


Intranasal remimazolam powder had a consistent absolute bioavailability of approximately 50%; T max  was 10 min; AUC and C max  were dose-proportional.",[],"['intranasal remimazolam', 'benzodiazepines', 'remimazolam (as powder or solution) with intranasal placebo and 4\xa0mg intravenous remimazolam', 'remimazolam', 'placebo', 'Remimazolam']","['Peak effects (drowsiness, relaxation, any, memory, response time', 'pharmacokinetics, pharmacodynamics, and safety', 'absolute bioavailability', 'nasal discomfort/pain', 'severe pain and discomfort', 'safe and caused sedative effects', 'bioavailability and loss of dose-proportionality in AUC and C max']",[],"[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C3179470', 'cui_str': 'remimazolam'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0858259', 'cui_str': 'Nasal discomfort'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C3179159', 'cui_str': 'Sedative Effects'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",,0.185135,"RESULTS


Intranasal remimazolam powder had a consistent absolute bioavailability of approximately 50%; T max  was 10 min; AUC and C max  were dose-proportional.","[{'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Pesic', 'Affiliation': 'PAION Deutschland GmbH, Martinstr. 10-12, 52062, Aachen, Germany. m.pesic@paion.com.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Schippers', 'Affiliation': 'PAION Deutschland GmbH, Martinstr. 10-12, 52062, Aachen, Germany.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Saunders', 'Affiliation': 'PAION Deutschland GmbH, Martinstr. 10-12, 52062, Aachen, Germany.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Webster', 'Affiliation': 'Early Development Services, Scientific Affairs, PRA Health Sciences, Salt Lake City, UT, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Donsbach', 'Affiliation': 'PAION Deutschland GmbH, Martinstr. 10-12, 52062, Aachen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stoehr', 'Affiliation': 'PAION Deutschland GmbH, Martinstr. 10-12, 52062, Aachen, Germany.'}]",European journal of clinical pharmacology,['10.1007/s00228-020-02984-z']
1492,32882163,"Prasugrel-based de-escalation of dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (HOST-REDUCE-POLYTECH-ACS): an open-label, multicentre, non-inferiority randomised trial.","BACKGROUND


A potent P2Y12 inhibitor-based dual antiplatelet therapy is recommended for up to 1 year in patients with acute coronary syndrome receiving percutaneous coronary intervention (PCI). The greatest benefit of the potent agent is during the early phase, whereas the risk of excess bleeding continues in the chronic maintenance phase. Therefore, de-escalation of antiplatelet therapy might achieve an optimal balance between ischaemia and bleeding. We aimed to investigate the safety and efficacy of a prasugrel-based dose de-escalation therapy.
METHODS


HOST-REDUCE-POLYTECH-ACS is a randomised, open-label, multicentre, non-inferiority trial done at 35 hospitals in South Korea. We enrolled patients with acute coronary syndrome receiving PCI. Patients meeting the core indication for prasugrel were randomly assigned (1:1) to the de-escalation group or conventional group using a web-based randomisation system. The assessors were masked to the treatment allocation. After 1 month of treatment with 10 mg prasugrel plus 100 mg aspirin daily, the de-escalation group received 5 mg prasugrel, while the conventional group continued to receive 10 mg. The primary endpoint was net adverse clinical events (all-cause death, non-fatal myocardial infarction, stent thrombosis, repeat revascularisation, stroke, and bleeding events of grade 2 or higher according to Bleeding Academic Research Consortium [BARC] criteria) at 1 year. The absolute non-inferiority margin for the primary endpoint was 2·5%. The key secondary endpoints were efficacy outcomes (cardiovascular death, myocardial infarction, stent thrombosis, and ischaemic stroke) and safety outcomes (bleeding events of BARC grade ≥2). The primary analysis was in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02193971.
RESULTS


From Sept 30, 2014, to Dec 18, 2018, 3429 patients were screened, of whom 1075 patients did not meet the core indication for prasugrel and 16 were excluded due to randomisation error. 2338 patients were randomly assigned to the de-escalation group (n=1170) or the conventional group (n=1168). The primary endpoint occurred in 82 patients (Kaplan-Meier estimate 7·2%) in the de-escalation group and 116 patients (10·1%) in the conventional group (absolute risk difference -2·9%, p non-inferiority <0·0001; hazard ratio 0·70 [95% CI 0·52-0·92], p equivalence =0·012). There was no increase in ischaemic risk in the de-escalation group compared with the conventional group (0·76 [0·40-1·45]; p=0·40), and the risk of bleeding events was significantly decreased (0·48 [0·32-0·73]; p=0·0007).
INTERPRETATION


In east Asian patients with acute coronary syndrome patients receiving PCI, a prasugrel-based dose de-escalation strategy from 1 month after PCI reduced the risk of net clinical outcomes up to 1 year, mainly driven by a reduction in bleeding without an increase in ischaemia.
FUNDING


Daiichi Sankyo, Boston Scientific, Terumo, Biotronik, Qualitech Korea, and Dio.",2020,"There was no increase in ischaemic risk in the de-escalation group compared with the conventional group (0·76 [0·40-1·45]; p=0·40), and the risk of bleeding events was significantly decreased (0·48 [0·32-0·73]; p=0·0007).
","['35 hospitals in South Korea', 'enrolled patients with acute coronary syndrome receiving PCI', 'patients with acute coronary syndrome (HOST-REDUCE-POLYTECH-ACS', '2338 patients', 'patients with acute coronary syndrome receiving percutaneous coronary intervention (PCI', 'From Sept 30, 2014, to Dec 18, 2018, 3429 patients were screened, of whom 1075 patients did not meet the core indication for prasugrel and 16 were excluded due to randomisation error', 'Patients meeting the core indication for prasugrel', 'east Asian patients with acute coronary syndrome patients receiving']","['prasugrel plus 100 mg aspirin', 'PCI', 'conventional group using a web-based randomisation system', 'P2Y12 inhibitor-based dual antiplatelet therapy', 'Prasugrel-based de-escalation of dual antiplatelet therapy', 'percutaneous coronary intervention', 'prasugrel-based dose de-escalation therapy']","['ischaemic risk', 'net adverse clinical events (all-cause death, non-fatal myocardial infarction, stent thrombosis, repeat revascularisation, stroke, and bleeding events of grade 2 or higher according to Bleeding Academic Research Consortium [BARC] criteria', 'safety and efficacy', 'risk of bleeding events', 'absolute non-inferiority margin', 'ischaemia', 'efficacy outcomes (cardiovascular death, myocardial infarction, stent thrombosis, and ischaemic stroke) and safety outcomes (bleeding events of BARC grade ≥2']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}]","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",3429.0,0.163141,"There was no increase in ischaemic risk in the de-escalation group compared with the conventional group (0·76 [0·40-1·45]; p=0·40), and the risk of bleeding events was significantly decreased (0·48 [0·32-0·73]; p=0·0007).
","[{'ForeName': 'Hyo-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Jeehoon', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Doyeon', 'Initials': 'D', 'LastName': 'Hwang', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Jung-Kyu', 'Initials': 'JK', 'LastName': 'Han', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Han-Mo', 'Initials': 'HM', 'LastName': 'Yang', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Hyun-Jae', 'Initials': 'HJ', 'LastName': 'Kang', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Bon-Kwon', 'Initials': 'BK', 'LastName': 'Koo', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Jay Young', 'Initials': 'JY', 'LastName': 'Rhew', 'Affiliation': 'Presbyterian Medical Center, Jeonju, South Korea.'}, {'ForeName': 'Kook-Jin', 'Initials': 'KJ', 'LastName': 'Chun', 'Affiliation': 'Pusan National University Yangsan Hospital, Yangsan, South Korea.'}, {'ForeName': 'Young-Hyo', 'Initials': 'YH', 'LastName': 'Lim', 'Affiliation': 'Hanyang University Seoul Hospital, Seoul, South Korea.'}, {'ForeName': 'Jung Min', 'Initials': 'JM', 'LastName': 'Bong', 'Affiliation': 'Hanlim General Hospital, Incheon, South Korea.'}, {'ForeName': 'Jang-Whan', 'Initials': 'JW', 'LastName': 'Bae', 'Affiliation': 'Chungbuk National University, Cheongju, South Korea.'}, {'ForeName': 'Bong Ki', 'Initials': 'BK', 'LastName': 'Lee', 'Affiliation': 'Kangwon National University, Chuncheon, South Korea.'}, {'ForeName': 'Kyung Woo', 'Initials': 'KW', 'LastName': 'Park', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea. Electronic address: kwparkmd@snu.ac.kr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31791-8']
1493,32857128,"Long-term Effects of Calcium β-Hydroxy-β-Methylbutyrate and Vitamin D3 Supplementation on Muscular Function in Older Adults With and Without Resistance Training: A Randomized, Double-blind, Controlled Study.","The primary aim of this study was to determine whether supplementation with calcium β-hydroxy-β-methylbutyrate (HMB) and vitamin D3 (D) would enhance muscle function and strength in older adults. Older adults over 60 years of age with insufficient circulating 25-hydroxy-vitamin D (25OH-D) levels were enrolled in a double-blinded controlled 12-month study. Study participants were randomly assigned to treatments consisting of: (a) Control + no exercise, (b) HMB+D + no exercise, (c) Control + exercise, and (d) HMB+D + exercise. The study evaluated 117 participants via multiple measurements over the 12 months that included body composition, strength, functionality, and questionnaires. HMB+D had a significant benefit on lean body mass within the nonexercise group at 6 months (0.44 ± 0.27 kg, HMB+D vs -0.33 ± 0.28 kg, control, p < .05). In nonexercisers, improvement in knee extension peak torque (60°/s) was significantly greater in HMB+D-supplemented participants than in the nonsupplemented group (p = .04) at 3 months, 10.9 ± 5.7 Nm and -5.2 ± 5.9 Nm, respectively. A composite functional index, integrating changes in handgrip, Get Up, and Get Up and Go measurements, was developed. HMB+D + no exercise resulted in significant increases in the functional index compared with those observed in the control + no exercise group at 3 (p = .03), 6 (p = .04), and 12 months (p = .04). Supplementation with HMB+D did not further improve the functional index within the exercising group. This study demonstrated the potential of HMB and vitamin D3 supplementation to enhance muscle strength and physical functionality in older adults, even in individuals not engaged in an exercise training program.",2020,"In non-exercisers, improvement in knee extension peak torque (60°/sec) was significantly greater in HMB+D supplemented participants than in non-supplemented group (p=0.04) at 3 months, 10.9 ± 5.7Nm and -5.2 ± 5.9Nm, respectively.","['older adults', 'Older Adults with and without Resistance Training', 'Older adults over 60 years of age with insufficient circulating 25-hydroxy-Vitamin D (25OH-D) levels', 'older adults, even in individuals not engaged in an exercise training program', '117 participants consisting of multiple measurements over the 12 months that included body composition, strength, functionality, and questionnaires']","['Calcium β-Hydroxy-β-methylbutyrate (HMB) and Vitamin D3 Supplementation', 'Control + no exercise; (b) HMB+D + no exercise; (c) Control + exercise, and (d) HMB+D + exercise', 'HMB and Vitamin D3 supplementation', 'calcium β-hydroxy-β-methylbutyrate (HMB) and Vitamin D3 (D', 'HMB+D + no exercise', 'HMB+D']","['Muscular Function', 'muscle strength and physical functionality', 'lean body mass', 'functional index', 'knee extension peak torque']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}]",117.0,0.119148,"In non-exercisers, improvement in knee extension peak torque (60°/sec) was significantly greater in HMB+D supplemented participants than in non-supplemented group (p=0.04) at 3 months, 10.9 ± 5.7Nm and -5.2 ± 5.9Nm, respectively.","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Rathmacher', 'Affiliation': 'MTI BioTech, Inc., Iowa State University Research Park, Ames.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Pitchford', 'Affiliation': 'MTI BioTech, Inc., Iowa State University Research Park, Ames.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khoo', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Angus', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lang', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Lowry', 'Affiliation': 'Department of Physical Therapy, Des Moines University.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Ruby', 'Affiliation': 'Department of Physical Therapy, Des Moines University.'}, {'ForeName': 'Alex C', 'Initials': 'AC', 'LastName': 'Krajek', 'Affiliation': 'Department of Physical Therapy, Des Moines University.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Fuller', 'Affiliation': 'Metabolic Technologies, LLC, Missoula, MT.'}, {'ForeName': 'Rick L', 'Initials': 'RL', 'LastName': 'Sharp', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa218']
1494,32858346,"Effects of treatment of sleep disorders on sleep, psychological and cognitive functioning and biomarkers in individuals with HIV/AIDS and under methadone maintenance therapy.","BACKGROUND


Poor sleep is a major complaint of people with human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) and undergoing methadone maintenance therapy (MMT). We tested the impact of three different sleep-improving interventions (trazodone; sleep hygiene training; sleep hygiene training + trazodone) on sleep, psychological functioning and biomarkers in males with HIV and undergoing MMT.
METHODS


A total of 75 male outpatients (mean age: 39.6 years) participated in a 12 week intervention. Participants were randomly assigned to one of the following conditions: trazodone 50 mg/d (TRAZ); sleep hygiene training (SHT); sleep hygiene training and trazodone (SHT + TRAZ). At baseline, and six and 12 weeks later, participants completed questionnaires covering subjective sleep and daytime sleepiness, and symptoms of depression and anxiety. In parallel, their cognitive performance (working memory; sustained attention) was assessed. Biomarkers (cortisol, BNDF, CD4 + ) were assessed at baseline and at the end of the study.
RESULTS


Over time, sleep disturbances decreased and daytime functioning and overall sleep quality improved. More specifically, both sleep disturbances and daytime functioning improved in the two SHT conditions from baseline to week 6. Daytime functioning remained stable from week 6 to week 12. Over time, in all conditions symptoms of depression and anxiety declined from baseline to week 6 and remained lower from week 6 to week 12. Daytime sleepiness, symptoms of insomnia and sleep-disordered breathing remained unchanged. Sustained attention performance improved over time from baseline to week 6 and remained high through to week 12. Biomarkers remained unchanged.
CONCLUSIONS


In males with HIV and undergoing MMT, treating sleep disturbances over a period of six to 12 weeks had a positive impact on aspects of sleep disturbance, symptoms of depression and anxiety, and cognitive performance. The results indicate that sleep hygiene training, either as stand-alone or in combination with trazodone, can produce positive results.",2020,"Over time, in all conditions symptoms of depression and anxiety declined from baseline to week 6 and remained lower from week 6 to week 12.","['75 male outpatients (mean age: 39.6 years) participated in a 12 week intervention', 'males with HIV and undergoing', 'males with HIV and undergoing MMT', 'people with human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) and undergoing', 'individuals with HIV/AIDS and under methadone maintenance therapy']","['MMT', 'methadone maintenance therapy (MMT', 'sleep-improving interventions (trazodone; sleep hygiene training; sleep hygiene training\xa0+\xa0trazodone', 'trazodone 50\xa0mg/d (TRAZ); sleep hygiene training (SHT); sleep hygiene training and trazodone (SHT\xa0+\xa0TRAZ', 'trazodone']","['sleep, psychological and cognitive functioning and biomarkers', 'sleep, psychological functioning and biomarkers', 'Daytime sleepiness, symptoms of insomnia and sleep-disordered breathing', 'questionnaires covering subjective sleep and daytime sleepiness, and symptoms of depression and anxiety', 'depression and anxiety', 'Sustained attention performance', 'sleep disturbances and daytime functioning', 'Daytime functioning', 'sleep disturbances', 'Biomarkers (cortisol, BNDF, CD4 + ', 'daytime functioning and overall sleep quality', 'sleep disturbance, symptoms of depression and anxiety, and cognitive performance']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001175', 'cui_str': 'AIDS'}]","[{'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",75.0,0.0231424,"Over time, in all conditions symptoms of depression and anxiety declined from baseline to week 6 and remained lower from week 6 to week 12.","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Alikhani', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ebrahimi', 'Affiliation': 'Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Farnia', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Habibolah', 'Initials': 'H', 'LastName': 'Khazaie', 'Affiliation': 'Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Radmehr', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Mohamadi', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Omran', 'Initials': 'O', 'LastName': 'Davarinejad', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Dürsteler', 'Affiliation': 'University of Basel, Psychiatric Clinics, Division of Substance Use Disorders Basel, Switzerland.'}, {'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Sadeghi Bahmani', 'Affiliation': 'Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran; University of Basel, Psychiatric Clinics, Center for Affective, Stress and Sleep Disorders, Basel, Switzerland; Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran; Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran; University of Basel, Psychiatric Clinics, Center for Affective, Stress and Sleep Disorders, Basel, Switzerland; University of Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland; Tehran University of Medical Sciences, School of Medicine, Tehran, Iran. Electronic address: serge.brand@upk.ch.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.043']
1495,32859118,Effects of the Preschool-Based Family-Involving DAGIS Intervention Program on Children's Energy Balance-Related Behaviors and Self-Regulation Skills: A Clustered Randomized Controlled Trial.,"The study examines the effects of a preschool-based family-involving multicomponent intervention on children's energy balance-related behaviors (EBRBs) such as food consumption, screen time and physical activity (PA), and self-regulation (SR) skills, and whether the intervention effects differed among children with low or high parental educational level (PEL) backgrounds. The Increased Health and Wellbeing in Preschools (DAGIS) intervention was conducted as a clustered randomized controlled trial, clustered at preschool level, over five months in 2017-2018. Altogether, 802 children aged 3-6 years in age participated. Parents reported children's consumption of sugary everyday foods and beverages, sugary treats, fruits, and vegetables by a food frequency questionnaire, and screen time by a 7-day diary. Physical activity was assessed by a hip-worn accelerometer. Cognitive and emotional SR was reported in a questionnaire by parents. General linear mixed models with and without repeated measures were used as statistical methods. At follow-up, no differences were detected in EBRBs or SR skills between the intervention and control group, nor did differences emerge in children's EBRBs between the intervention and the control groups when stratified by PEL. The improvement in cognitive SR skills among low PEL intervention children differed from low PEL control children, the significance being borderline. The DAGIS multicomponent intervention did not significantly affect children's EBRBs or SR. Further sub-analyses and a comprehensive process evaluation may shed light on the non-significant findings.",2020,"At follow-up, no differences were detected in EBRBs or SR skills between the intervention and control group, nor did differences emerge in children's EBRBs between the intervention and the control groups when stratified by PEL.","['802 children aged 3-6 years in age participated', 'children with low or high parental educational level (PEL) backgrounds']","['Preschool-Based Family-Involving DAGIS Intervention Program', 'preschool-based family-involving multicomponent intervention']","[""Children's Energy Balance-Related Behaviors and Self-Regulation Skills"", 'cognitive SR skills', 'Cognitive and emotional SR', 'Physical activity', 'EBRBs or SR skills', ""children's energy balance-related behaviors (EBRBs) such as food consumption, screen time and physical activity (PA), and self-regulation (SR) skills"", ""children's consumption of sugary everyday foods and beverages, sugary treats, fruits, and vegetables by a food frequency questionnaire, and screen time"", ""children's EBRBs"", ""children's EBRBs or SR""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0524819', 'cui_str': 'Foods and drinks'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",802.0,0.028353,"At follow-up, no differences were detected in EBRBs or SR skills between the intervention and control group, nor did differences emerge in children's EBRBs between the intervention and the control groups when stratified by PEL.","[{'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Ray', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Rejane', 'Initials': 'R', 'LastName': 'Figuereido', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Henna', 'Initials': 'H', 'LastName': 'Vepsäläinen', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, P.O. Box 66, FI-00014 Helsinki, Finland.'}, {'ForeName': 'Reetta', 'Initials': 'R', 'LastName': 'Lehto', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Riikka', 'Initials': 'R', 'LastName': 'Pajulahti', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Essi', 'Initials': 'E', 'LastName': 'Skaffari', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Sainio', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Pauliina', 'Initials': 'P', 'LastName': 'Hiltunen', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Elviira', 'Initials': 'E', 'LastName': 'Lehto', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Liisa', 'Initials': 'L', 'LastName': 'Korkalo', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, P.O. Box 66, FI-00014 Helsinki, Finland.'}, {'ForeName': 'Katri', 'Initials': 'K', 'LastName': 'Sääksjärvi', 'Affiliation': 'Department of Teacher Education, University of Helsinki, P.O. Box 9, FI-00100 Helsinki, Finland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Sajaniemi', 'Affiliation': 'Department of Teacher Education, University of Helsinki, P.O. Box 9, FI-00100 Helsinki, Finland.'}, {'ForeName': 'Maijaliisa', 'Initials': 'M', 'LastName': 'Erkkola', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, P.O. Box 66, FI-00014 Helsinki, Finland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Roos', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}]",Nutrients,['10.3390/nu12092599']
1496,32860783,"Development, application, and evaluation of a problem-based learning method in clinical laboratory education.","BACKGROUND


There is a big gap between theory and real clinical practice with respect to the structure of clinical laboratory medicine (CLM) education in China. An integrated teaching method is urgently required, to improve student competency and prepare students to deal with complex challenges in the working environment.
METHODS


A total of 122 fourth-year CLM students studying at Hubei University between 2018 and 2019 were randomly assigned to a traditional teaching methods group or a problem-based learning (PBL) group. In the PBL group students were instructed to exchange their thoughts, identify information gaps, rehearse and perform simulated clinical scenarios, and incorporate the new information into cases in small groups. Theory tests, questionnaires, and clinical performance assessments were used to evaluate the effectiveness of PBL and compare it with that of traditional teaching methods.
RESULTS


PBL resulted in significantly better theory test scores, better student feedback scores, and clinical performance assessments, and a higher rate of satisfaction among students and teachers.
CONCLUSION


PBL is an effective way to help CLM students develop comprehensive abilities to deal with real clinical laboratory work. It is a promising education method and should be generalized to all subtypes of clinical laboratory curriculums in the future.",2020,"RESULTS


PBL resulted in significantly better theory test scores, better student feedback scores, and clinical performance assessments, and a higher rate of satisfaction among students and teachers.
",['A total of 122 fourth-year CLM students studying at Hubei University between 2018 and 2019'],['traditional teaching methods group or a problem-based learning (PBL) group'],"['theory test scores, better student feedback scores, and clinical performance assessments']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0039403', 'cui_str': 'Teaching Methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0485131,"RESULTS


PBL resulted in significantly better theory test scores, better student feedback scores, and clinical performance assessments, and a higher rate of satisfaction among students and teachers.
","[{'ForeName': 'Xiandong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Laboratory Medicine, Taihe hospital, Hubei University of Medicine, Shiyan 442000, Hubei, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Laboratory Medicine, Taihe hospital, Hubei University of Medicine, Shiyan 442000, Hubei, China.'}, {'ForeName': 'Xiaoqiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Laboratory Medicine, Taihe hospital, Hubei University of Medicine, Shiyan 442000, Hubei, China.'}, {'ForeName': 'Guangwu', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Clinical laboratory Science, Hubei University of Medicine, Shiyan 442000, Hubei, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical laboratory Science, Hubei University of Medicine, Shiyan 442000, Hubei, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lv', 'Affiliation': 'Department of Laboratory Medicine, Taihe hospital, Hubei University of Medicine, Shiyan 442000, Hubei, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': 'Department of Laboratory Medicine, Taihe hospital, Hubei University of Medicine, Shiyan 442000, Hubei, China; Department of Clinical laboratory Science, Hubei University of Medicine, Shiyan 442000, Hubei, China; Hubei Key Laboratory of Embryonic Stem Cell research, Hubei University of Medicine, Shiyan 442000, Hubei, China. Electronic address: chunyan_peng@taihehospital.com.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.08.037']
1497,32865373,Evolocumab in Pediatric Heterozygous Familial Hypercholesterolemia.,"BACKGROUND


Evolocumab, a fully human monoclonal antibody directed against proprotein convertase subtilisin-kexin type 9, is widely used in adult patients to lower low-density lipoprotein (LDL) cholesterol levels. Its effects in pediatric patients with heterozygous familial hypercholesterolemia are not known.
METHODS


We conducted a 24-week, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of evolocumab in pediatric patients with heterozygous familial hypercholesterolemia. Patients 10 to 17 years of age who had received stable lipid-lowering treatment for at least 4 weeks before screening and who had an LDL cholesterol level of 130 mg per deciliter (3.4 mmol per liter) or more and a triglyceride level of 400 mg per deciliter (4.5 mmol per liter) or less were randomly assigned in a 2:1 ratio to receive monthly subcutaneous injections of evolocumab (420 mg) or placebo. The primary end point was the percent change in LDL cholesterol level from baseline to week 24; key secondary end points were the mean percent change in LDL cholesterol level from baseline to weeks 22 and 24 and the absolute change in LDL cholesterol level from baseline to week 24.
RESULTS


A total of 157 patients underwent randomization and received evolocumab (104 patients) or placebo (53 patients). At week 24, the mean percent change from baseline in LDL cholesterol level was -44.5% in the evolocumab group and -6.2% in the placebo group, for a difference of -38.3 percentage points (P<0.001). The absolute change in the LDL cholesterol level was -77.5 mg per deciliter (-2.0 mmol per liter) in the evolocumab group and -9.0 mg per deciliter (-0.2 mmol per liter) in the placebo group, for a difference of -68.6 mg per deciliter (-1.8 mmol per liter) (P<0.001). Results for all secondary lipid variables were significantly better with evolocumab than with placebo. The incidence of adverse events that occurred during the treatment period was similar in the evolocumab and placebo groups.
CONCLUSIONS


In this trial involving pediatric patients with familial hypercholesterolemia, evolocumab reduced the LDL cholesterol level and other lipid variables. (Funded by Amgen; HAUSER-RCT ClinicalTrials.gov number, NCT02392559.).",2020,"At week 24, the mean percent change from baseline in LDL cholesterol level was -44.5% in the evolocumab group and -6.2% in the placebo group, for a difference of -38.3 percentage points (P<0.001).","['104 patients) or', 'adult patients to lower low-density lipoprotein (LDL) cholesterol levels', 'Pediatric Heterozygous Familial Hypercholesterolemia', '157 patients underwent randomization and received', 'pediatric patients with heterozygous familial hypercholesterolemia', 'pediatric patients with familial hypercholesterolemia', 'Patients 10 to 17 years of age who had received stable lipid-lowering treatment for at least 4 weeks before screening and who had an LDL cholesterol level of 130 mg per deciliter (3.4 mmol per liter) or more and a triglyceride level of 400 mg per deciliter (4.5 mmol per liter) or less']","['Evolocumab', 'evolocumab (420 mg) or placebo', 'placebo', 'evolocumab']","['efficacy and safety', 'incidence of adverse events', 'LDL cholesterol level']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0342882', 'cui_str': 'Familial hypercholesterolemia - heterozygous'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0020445', 'cui_str': 'Familial hypercholesterolemia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439241', 'cui_str': 'dL'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3844009', 'cui_str': '4.5'}]","[{'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}]",157.0,0.65015,"At week 24, the mean percent change from baseline in LDL cholesterol level was -44.5% in the evolocumab group and -6.2% in the placebo group, for a difference of -38.3 percentage points (P<0.001).","[{'ForeName': 'Raul D', 'Initials': 'RD', 'LastName': 'Santos', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ruzza', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'G Kees', 'Initials': 'GK', 'LastName': 'Hovingh', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Wiegman', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Mach', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Kurtz', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hamer', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Bridges', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bartuli', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bergeron', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Szamosi', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Saikat', 'Initials': 'S', 'LastName': 'Santra', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Stefanutti', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Olivier S', 'Initials': 'OS', 'LastName': 'Descamps', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Greber-Platzer', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Luirink', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'John J P', 'Initials': 'JJP', 'LastName': 'Kastelein', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gaudet', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2019910']
1498,32865374,Low-Dose Edoxaban in Very Elderly Patients with Atrial Fibrillation.,"BACKGROUND


Implementation of appropriate oral anticoagulant treatment for the prevention of stroke in very elderly patients with atrial fibrillation is challenging because of concerns regarding bleeding.
METHODS


We conducted a phase 3, multicenter, randomized, double-blind, placebo-controlled, event-driven trial to compare a once-daily 15-mg dose of edoxaban with placebo in elderly Japanese patients (≥80 years of age) with nonvalvular atrial fibrillation who were not considered to be appropriate candidates for oral anticoagulant therapy at doses approved for stroke prevention. The primary efficacy end point was the composite of stroke or systemic embolism, and the primary safety end point was major bleeding according to the definition of the International Society on Thrombosis and Haemostasis.
RESULTS


A total of 984 patients were randomly assigned in a 1:1 ratio to receive a daily dose of 15 mg of edoxaban (492 patients) or placebo (492 patients). A total of 681 patients completed the trial, and 303 discontinued (158 withdrew, 135 died, and 10 had other reasons); the numbers of patients who discontinued the trial were similar in the two groups. The annualized rate of stroke or systemic embolism was 2.3% in the edoxaban group and 6.7% in the placebo group (hazard ratio, 0.34; 95% confidence interval [CI], 0.19 to 0.61; P<0.001), and the annualized rate of major bleeding was 3.3% in the edoxaban group and 1.8% in the placebo group (hazard ratio, 1.87; 95% CI, 0.90 to 3.89; P = 0.09). There were substantially more events of gastrointestinal bleeding in the edoxaban group than in the placebo group. There was no substantial between-group difference in death from any cause (9.9% in the edoxaban group and 10.2% in the placebo group; hazard ratio, 0.97; 95% CI, 0.69 to 1.36).
CONCLUSIONS


In very elderly Japanese patients with nonvalvular atrial fibrillation who were not appropriate candidates for standard doses of oral anticoagulants, a once-daily 15-mg dose of edoxaban was superior to placebo in preventing stroke or systemic embolism and did not result in a significantly higher incidence of major bleeding than placebo. (Funded by Daiichi Sankyo; ELDERCARE-AF ClinicalTrials.gov number, NCT02801669.).",2020,"There was no substantial between-group difference in death from any cause (9.9% in the edoxaban group and 10.2% in the placebo group; hazard ratio, 0.97; 95% CI, 0.69 to 1.36).
","['elderly Japanese patients (≥80 years of age) with nonvalvular atrial fibrillation who were not considered to be appropriate candidates for oral anticoagulant therapy at doses approved for stroke prevention', '681 patients completed the trial, and 303 discontinued (158 withdrew, 135 died, and 10 had other reasons); the numbers of patients who discontinued the trial were similar in the two groups', 'elderly patients with atrial fibrillation', 'elderly Japanese patients with nonvalvular atrial fibrillation who were not appropriate candidates for standard doses of', 'A total of 984 patients', 'Very Elderly Patients with Atrial Fibrillation']","['oral anticoagulants', 'edoxaban', 'placebo', 'edoxaban with placebo', 'Low-Dose Edoxaban']","['stroke or systemic embolism', 'gastrointestinal bleeding', 'death', 'annualized rate of stroke or systemic embolism', 'composite of stroke or systemic embolism, and the primary safety end point was major bleeding according to the definition of the International Society on Thrombosis and Haemostasis', 'major bleeding', 'annualized rate of major bleeding']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C1277289', 'cui_str': 'Stroke prevention'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}]",984.0,0.67237,"There was no substantial between-group difference in death from any cause (9.9% in the edoxaban group and 10.2% in the placebo group; hazard ratio, 0.97; 95% CI, 0.69 to 1.36).
","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Okumura', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Akao', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Kawata', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Okazaki', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Akashi', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Eshima', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Kimihiko', 'Initials': 'K', 'LastName': 'Tanizawa', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Fukuzawa', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Akishita', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2012883']
1499,32861841,Longitudinal trajectories of mood symptoms and global functioning in youth at high risk for bipolar disorder.,"BACKGROUND


Little is known about the longitudinal course of mood symptoms and functioning in youth who are at high risk for bipolar disorder (BD). Identifying distinct course trajectories and predictors of those trajectories may help refine treatment approaches.
METHODS


This study examined the longitudinal course of mood symptoms and functioning ratings in 126 youth at high risk for BD based on family history and early mood symptoms. Participants were enrolled in a randomized trial of family-focused therapy and followed longitudinally (mean 2.0 years, SD = 53.6 weeks).
RESULTS


Using latent class growth analyses (LCGA), we observed three mood trajectories. All youth started the study with active mood symptoms. Following the index mood episode, participants were classified as having a ""significantly improving course"" (n = 41, 32.5% of sample), a ""moderately symptomatic course"" (n = 21, 16.7%), or a ""predominantly symptomatic course"" (n = 64, 50.8%) at follow-up. More severe depression, anxiety, and suicidality at the study's baseline were associated with a poorer course of illness. LCGA also revealed three trajectories of global functioning that closely corresponded to symptom trajectories; however, fewer youth exhibited functional recovery than exhibited symptomatic recovery.
LIMITATIONS


Mood trajectories were assessed within the context of a treatment trial. Ratings of mood and functioning were based on retrospective recall.
CONCLUSIONS


This study suggests considerable heterogeneity in the course trajectories of youth at high risk for BD, with a significant proportion (32.5%) showing long-term remission of symptoms. Treatments that enhance psychosocial functioning may be just as important as those that ameliorate symptoms in youth at risk for BD.",2020,"More severe depression, anxiety, and suicidality at the study's baseline were associated with a poorer course of illness.","['126 youth at high risk for BD based on family history and early mood symptoms', 'youth at high risk for bipolar disorder', 'youth who are at high risk for bipolar disorder (BD']",['LCGA'],"['severe depression, anxiety, and suicidality']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0241889', 'cui_str': 'Family history of clinical finding'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0524716,"More severe depression, anxiety, and suicidality at the study's baseline were associated with a poorer course of illness.","[{'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Weintraub', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, 760 Westwood Plaza, A7-370, Los Angeles 90095, CA, USA. Electronic address: mjweintraub@mednet.ucla.edu.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Schneck', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Patricia D', 'Initials': 'PD', 'LastName': 'Walshaw', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, 760 Westwood Plaza, A7-370, Los Angeles 90095, CA, USA.'}, {'ForeName': 'Kiki D', 'Initials': 'KD', 'LastName': 'Chang', 'Affiliation': 'Private Practice, Menlo Park, CA, USA.'}, {'ForeName': 'Aimee E', 'Initials': 'AE', 'LastName': 'Sullivan', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Manpreet K', 'Initials': 'MK', 'LastName': 'Singh', 'Affiliation': 'School of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, 760 Westwood Plaza, A7-370, Los Angeles 90095, CA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.018']
1500,32862662,Initial Invasive versus Conservative Management of Stable Ischemic Heart Disease Patients with a History of Heart Failure or Left Ventricular Dysfunction: Insights from the ISCHEMIA Trial.,"Background:  It is unknown whether an initial invasive strategy in patients with stable ischemic heart disease and at least moderate ischemia improves outcomes in patients with a history of heart failure (HF) or left ventricular dysfunction (LVD) when EF ≥35%, but <45%.  Methods:  Among 5179 participants randomized into the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA), all of whom had LVEF ≥35%, we compared cardiovascular outcomes by treatment strategy in those with a history of HF or LV dysfunction (HF/LVD) at baseline versus those without HF/LVD. Median followup was 3.2 years.  Results:  There were 398 (7.7%) participants with HF/LVD at baseline of whom 177 had HF/LVEF>45%, 28 had HF/LVEF 35-45% and 193 had LVEF 35-45% but no prior history of HF. HF/LVD was associated with more comorbidities at baseline, particularly prior myocardial infarction (MI), stroke and hypertension. Compared to those without HF/LVD, those with HF/LVD were more likely to experience a primary outcome composite of cardiovascular death, nonfatal MI, or hospitalization for unstable angina, HF, or resuscitated cardiac arrest; four-year cumulative incidence rate (22.7% vs. 13.8%), cardiovascular death or MI (19.7% vs. 12.3%), and all-cause death or HF (15.0% vs. 6.9%). Those with HF/LVD randomized to the invasive versus conservative strategy had a lower rate of the primary outcome (17.2% vs. 29.3%, difference in 4-year event rate -12.1%; 95% CI: -22.6, -1.6%), whereas those without HF/LVD did not (13.0% vs. 14.6%, difference in 4-year event rate -1.6%; 95% CI: -3.8%, 0.7%; p-interaction = 0.055). A similar differential effect was seen for the primary outcome, all-cause mortality, and CV mortality when invasive versus conservative strategy associated outcomes were analyzed with LVEF as a continuous variable for those with and without prior HF.  Conclusions:  ISCHEMIA trial participants with stable ischemic heart disease and at least moderate ischemia with a history of HF or LVD were at increased risk for the primary outcome. In the small, high-risk subgroup with HF and LVEF 35-45%, an initial invasive approach was associated with a better event-free survival. This result should be considered hypothesis generating.  Clinical Trial Registration:  URL: https://clinicaltrials.gov Unique Identifier: NCT01471522.",2020,"HF/LVD was associated with more comorbidities at baseline, particularly prior myocardial infarction (MI), stroke and hypertension.","['5179 participants', 'Stable Ischemic Heart Disease Patients with a History of Heart Failure or Left Ventricular Dysfunction', 'participants with stable ischemic heart disease and at least moderate ischemia with a history of HF or LVD', 'patients with stable ischemic heart disease', 'patients with a history of heart failure (HF) or left ventricular dysfunction (LVD']",['Initial Invasive versus Conservative Management'],"['better event-free survival', 'cardiovascular death or MI', 'cause mortality, and CV mortality', 'cardiovascular death, nonfatal MI, or hospitalization for unstable angina, HF, or resuscitated cardiac arrest; four-year cumulative incidence rate', 'myocardial infarction (MI), stroke and hypertension']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0242698', 'cui_str': 'Impaired left ventricular function'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",5179.0,0.202193,"HF/LVD was associated with more comorbidities at baseline, particularly prior myocardial infarction (MI), stroke and hypertension.","[{'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Susanna R', 'Initials': 'SR', 'LastName': 'Stevens', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Cardiovascular Research Foundation, New York NY.'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Pina', 'Affiliation': 'Wayne State Univ/Central Michigan University, Detroit, MI.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elghamaz', 'Affiliation': 'Northwick Park Hospital-Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Lopez-Sendon', 'Affiliation': 'Hospital Universitario La Paz, IdiPaz, CIBER-CV. Madrid, Spain.'}, {'ForeName': 'Pedro S', 'Initials': 'PS', 'LastName': 'Farsky', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Chernyavskiy', 'Affiliation': 'E. Meshalkin National medical research center of the Ministry of Health of the Russian Federation (E.Meshalkin NMRC), Russia.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Diaz', 'Affiliation': 'CIUSSSMCQ, University of Montreal, Campus Mauricie, Trois-Rivieres, Canada.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Phaneuf', 'Affiliation': 'Hôpital Pierre-Le Gardeur, Quebec, Canada.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'DeBelder', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Yi-Tong', 'Initials': 'YT', 'LastName': 'Ma', 'Affiliation': 'First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Guzman', 'Affiliation': 'DAMIC Medical Institute, Cordoba, Argentina.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Khouri', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sionis', 'Affiliation': 'Intensive Cardiac Care Unit, Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIB-Sant Pau, CIBER-CV, Universitat Autònoma de Barcelona, Spain.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Hausenloy', 'Affiliation': 'The Hatter Cardiovascular Institute, Institute of Cardiovascular Sciences, University College London, London, UK; Cardiovascular & Metabolic Disorders Program, Duke-National University of Singapore Medical School, Singapore; National Heart Research Institute Singapore, National Heart Centre, Singapore; Yong Loo Lin School of Medicine, National University Singapore, Singapore; Cardiovascular Research Center, College of Medical and Health Sciences, Asia University, Taiwan.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Doerr', 'Affiliation': 'Praxisklinik Herz und Gefaesse, Dresden, Germany.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Selvanayagam', 'Affiliation': 'Flinders Medical Centre, Adelaide, Australia.'}, {'ForeName': 'Aldo Pietro', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'ANMCO Research Center, Florence, Italy.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Stanford, CA.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.050304']
1501,32876871,[Effectiveness of nurse-led care: a prospective randomized controlled multicenter study (ERFASS)].,,2020,,[],['nurse-led care'],[],[],"[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",[],,0.0505769,,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hoeper', 'Affiliation': 'Klinik für Rheumatologie und Immunologie, Medizinische Hochschule Hannover, Carl-Neuberg-Str.\xa01, 30625, Hannover, Deutschland. hoeper.kirsten@mh-hannover.de.'}]",Zeitschrift fur Rheumatologie,['10.1007/s00393-020-00863-7']
1502,32872401,"Influence of Short-Term Hyperenergetic, High-Fat Feeding on Appetite, Appetite-Related Hormones, and Food Reward in Healthy Men.","Short-term overfeeding may provoke compensatory appetite responses to correct the energy surplus. However, the initial time-course of appetite, appetite-related hormone, and reward-related responses to hyperenergetic, high-fat diets (HE-HFD) are poorly characterised. Twelve young healthy men consumed a HE-HFD (+50% energy, 65% fat) or control diet (36% fat) for seven days in a randomised crossover design. Mean appetite perceptions were determined during an oral glucose tolerance test (OGTT) before and after each diet. Fasted appetite perceptions, appetite-related hormones, and reward parameters were measured pre-diet and after 1-, 3- and 7-days of each diet. The HE-HFD induced a pre-to-post diet suppression in mean appetite during the OGTT (all ratings  p  ≤ 0.058, effect size ( d ) ≥ 0.31), and reduced the preference for high-fat vs. low-fat foods (main effect diet  p  = 0.036,  d  = 0.32). Fasted leptin was higher in the HE-HFD than control diet (main effect diet  p  < 0.001,  d  = 0.30), whilst a diet-by-time interaction ( p  = 0.036) revealed fasted acylated ghrelin was reduced after 1-, 3- and 7-days of the HE-HFD (all  p  ≤ 0.040,  d  ≥ 0.50 vs. pre-diet). Appetite perceptions and total peptide YY in the fasted state exhibited similar temporal patterns between the diets (diet-by-time interaction  p  ≥ 0.077). Seven days of high-fat overfeeding provokes modest compensatory changes in subjective, hormonal, and reward-related appetite parameters.",2020,"Seven days of high-fat overfeeding provokes modest compensatory changes in subjective, hormonal, and reward-related appetite parameters.","['Healthy Men', 'Twelve young healthy men']","['control diet ', 'Short-Term Hyperenergetic, High-Fat Feeding', 'control diet', 'HE-HFD']","['Appetite perceptions and total peptide YY', 'subjective, hormonal, and reward-related appetite parameters', 'Fasted leptin', 'Mean appetite perceptions', 'mean appetite', 'Fasted appetite perceptions, appetite-related hormones, and reward parameters']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0521974', 'cui_str': 'High fat diet'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}]",12.0,0.0163331,"Seven days of high-fat overfeeding provokes modest compensatory changes in subjective, hormonal, and reward-related appetite parameters.","[{'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Thackray', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough LE1 3TU, UK.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Willis', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough LE1 3TU, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Clayton', 'Affiliation': 'School of Science and Technology, Nottingham Trent University, Nottingham NG1 8NS, UK.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Broom', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, Coventry CV1 2DS, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Fernanda R', 'Initials': 'FR', 'LastName': 'Goltz', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough LE1 3TU, UK.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Sargeant', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester LE5 4PW, UK.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Woods', 'Affiliation': 'Medical School, University of Lincoln, Lincoln LN6 7TS, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stensel', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough LE1 3TU, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'King', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough LE1 3TU, UK.'}]",Nutrients,['10.3390/nu12092635']
1503,32872411,Supplemental Nutrition Assistance Program-Education Improves Food Security Independent of Food Assistance and Program Characteristics.,"The purpose of this project was to determine whether consistent food assistance program participation or changes in participation over time mediated or moderated the effect of federal nutrition education through the Supplemental Nutrition Assistance Program-Education (SNAP-Ed) on food security and determine the associations of SNAP-Ed program delivery characteristics with change in food security. This secondary analysis used data from a randomized controlled trial from September 2013 through April 2015. SNAP-Ed-eligible participants ( n  = 328; ≥18 years) in households with children were recruited from 39 counties in Indiana, USA. The dependent variable was one year change in household food security score measured using the United States Household Food Security Survey Module. Assessment of mediation used Barron-Kenny analysis and moderation used interactions of food assistance program use and changes over time with treatment group in general linear regression modeling. Program delivery characteristics were investigated using mixed linear regression modeling. Results showed that neither consistent participation nor changes in food assistance program participation over time mediated nor moderated the effect of SNAP-Ed on food security and neither were SNAP-Ed program delivery characteristics associated with change in food security over the one year study period. SNAP-Ed directly improved food security among SNAP-Ed-eligible Indiana households with children regardless of food assistance program participation and changes over time or varying program delivery characteristics.",2020,Results showed that neither consistent participation nor changes in food assistance program participation over time mediated nor moderated the effect of SNAP-Ed on food security and neither were SNAP-Ed program delivery characteristics associated with change in food security over the one year study period.,"['SNAP-Ed-eligible participants ( n  = 328; ≥18 years) in households with children were recruited from 39 counties in Indiana, USA', 'September 2013 through April 2015']",[],"['food security', 'household food security score']","[{'cui': 'C3494397', 'cui_str': 'SNAP Program'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021206', 'cui_str': 'Indiana'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]",[],"[{'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0457407,Results showed that neither consistent participation nor changes in food assistance program participation over time mediated nor moderated the effect of SNAP-Ed on food security and neither were SNAP-Ed program delivery characteristics associated with change in food security over the one year study period.,"[{'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Eicher-Miller', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN 47907, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Rivera', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN 47907, USA.'}, {'ForeName': 'Hanxi', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN 47907, USA.'}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN 47907, USA.'}, {'ForeName': 'Melissa K', 'Initials': 'MK', 'LastName': 'Maulding', 'Affiliation': 'Health and Human Sciences Cooperative Extension, Purdue University, West Lafayette, IN 47907, USA.'}, {'ForeName': 'Angela R', 'Initials': 'AR', 'LastName': 'Abbott', 'Affiliation': 'Health and Human Sciences Cooperative Extension, Purdue University, West Lafayette, IN 47907, USA.'}]",Nutrients,['10.3390/nu12092636']
1504,32872431,Emotional Education in Early Onset Schizophrenia and Asperger's Syndrome.,"In this study, we aim to verify how emotional training can improve empathy and theory of mind (ToM) in patients diagnosed with early onset schizophrenia and Asperger's syndrome. The study design includes 100 subjects divided into two experimental groups and two control groups. The two experimental groups followed a rational emotive behavior therapy (REBT) protocol. The two control groups instead underwent cognitive behavioral psychotherapy training. Analysis of Variance (ANOVA) was applied to analyze the difference between the Asperger's syndrome (AS) and early onset schizophrenia (EOS) groups, pre and post training. Our analysis shows that the AS group improved post emotional training but only when emotions were internalized, as demonstrated by the improvement of the scores in the post-treatment eye test (ET) but not in the emotional quotient (EQ) test. The EOS group instead showed post-training improvement, not only concerning skills leading to internalizing emotions but also in empathy, as demonstrated by the improvement of EQ and Reflective Functioning Questionnaire (RFQ) test scores. These scores remained lower than in the control group. Finally, our findings reveal that the value of the treatment was more considerable for the EOS group than for the AS group due to the improvement in first- and second-order ToM skills and an improvement of empathic skills in the first group, followed by the group comprising AS subjects. In the AS group, the treatment only favored the enhancement of first-order ToM skills; however, this improved quality of life and social adaptation.",2020,"The EOS group instead showed post-training improvement, not only concerning skills leading to internalizing emotions but also in empathy, as demonstrated by the improvement of EQ and Reflective Functioning Questionnaire (RFQ) test scores.","['100 subjects divided into two experimental groups and two control groups', ""patients diagnosed with early onset schizophrenia and Asperger's syndrome"", ""Early Onset Schizophrenia and Asperger's Syndrome""]","['emotional training', 'cognitive behavioral psychotherapy training', 'rational emotive behavior therapy (REBT) protocol']","['internalizing emotions', 'EQ and Reflective Functioning Questionnaire (RFQ) test scores', 'empathy and theory of mind (ToM', 'post emotional training', 'Emotional Education', 'quality of life and social adaptation', 'empathic skills']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1656427', 'cui_str': 'Early onset schizophrenia'}, {'cui': 'C0236792', 'cui_str': ""Asperger's disorder""}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",100.0,0.0114394,"The EOS group instead showed post-training improvement, not only concerning skills leading to internalizing emotions but also in empathy, as demonstrated by the improvement of EQ and Reflective Functioning Questionnaire (RFQ) test scores.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Frolli', 'Affiliation': 'DRC-Disability Research Centre, University of International Studies of Rome, 00147 Rome, Italy.'}, {'ForeName': 'Maria Carla', 'Initials': 'MC', 'LastName': 'Ricci', 'Affiliation': 'FINDS-Italian Neuroscience and Developmental Disorders Foundation, 81040 Caserta, Italy.'}, {'ForeName': 'Francesco Alberto', 'Initials': 'FA', 'LastName': 'Tortorelli', 'Affiliation': 'SPEE-Specialization School in Cognitive Behavioral Psychotherapy for Developmental Age Disorders, 80142 Naples, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Cavallaro', 'Affiliation': 'SPEE-Specialization School in Cognitive Behavioral Psychotherapy for Developmental Age Disorders, 80142 Naples, Italy.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Valenzano', 'Affiliation': 'FINDS-Italian Neuroscience and Developmental Disorders Foundation, 81040 Caserta, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Rega', 'Affiliation': 'Department of Psychology, University of Naples, 80100 Naples, Italy.'}, {'ForeName': 'Francesca Felicia', 'Initials': 'FF', 'LastName': 'Operto', 'Affiliation': 'Department of Child Neuropsychiatry, University of Salerno, 84080 Fisciano, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Corrivetti', 'Affiliation': 'ASL (SA), Department of Mental Health, 84122 Salerno, Italy.'}]","Behavioral sciences (Basel, Switzerland)",['10.3390/bs10090131']
1505,32871530,Efficacy of light therapy for a college student sample with non-seasonal subthreshold depression: An RCT study.,"BACKGROUND


Light therapy has been successfully used to treat seasonal and non-seasonal depression, but there is limited evidence for its efficacy in subthreshold depression. This study examines the efficacy of light therapy for symptoms of depression and anxiety in non-seasonal subthreshold depression.
METHODS


College students with non-seasonal subthreshold depression were recruited. The participants were randomly allocated to one of the three conditions: high- (LT-5000 lux) and low-intensity (LT-500 lux) light therapy conditions and a waiting-list control condition (WLC). The primary outcome was Hamilton Depression Rating Scale (HAMD), and secondary outcomes were Beck Depression Inventory-II (BDI-II) and state anxiety inventory (SAI), which were assessed at baseline (Week 0), during the trial (Week 4), and after completion of the light therapy (Week 8).
RESULTS


A total of 142 participants completed the trial. The LT-5000 (effect size [d] = 1.56, 95% CI: 1.15 to 1.98) and LT-500 conditions (d = 0.84, 95% CI: 0.43 to 1.26) were significantly superior to the WLC condition. For the LT-5000, LT-500, and WLC conditions by the end of the 8-week trial, a response on the HAMD was achieved by 70.0%, 42.0% and 19.0% of the participants, and remission was achieved by 76.0%, 54.0%, and 19.0%, respectively.
LIMITATIONS


The subjects were not followed up regularly after completion of the trial.
CONCLUSION


Light therapy, both at high- and low-intensity, was efficacious in the treatment of college students with non-seasonal subthreshold depression. High-intensity light therapy was superior to low-intensity light therapy by the end of an 8-week trial.",2020,"The LT-5000 (effect size [d] = 1.56, 95% CI: 1.15 to 1.98) and LT-500 conditions (d = 0.84, 95% CI: 0.43 to 1.26) were significantly superior to the WLC condition.","['142 participants completed the trial', 'college students with non-seasonal subthreshold depression', 'College students with non-seasonal subthreshold depression were recruited', 'college student sample with non-seasonal subthreshold depression']","['High-intensity light therapy', 'high- (LT-5000 lux) and low-intensity (LT-500 lux) light therapy conditions and a waiting-list control condition (WLC', 'light therapy']","['HAMD', 'remission', 'LT-500 conditions', 'Hamilton Depression Rating Scale (HAMD), and secondary outcomes were Beck Depression Inventory-II (BDI-II) and state anxiety inventory (SAI']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0521113', 'cui_str': 'Non-seasonal'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0024176', 'cui_str': 'Luxembourg'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",142.0,0.100785,"The LT-5000 (effect size [d] = 1.56, 95% CI: 1.15 to 1.98) and LT-500 conditions (d = 0.84, 95% CI: 0.43 to 1.26) were significantly superior to the WLC condition.","[{'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Public Health and Preventive Medicine, School of Basic Medicine, Jinan University, Guangzhou 510632, China; Division of Medical Psychology and Behavior Science, School of Basic Medicine, Jinan University, Guangzhou 510632, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Public Health and Preventive Medicine, School of Basic Medicine, Jinan University, Guangzhou 510632, China; Division of Medical Psychology and Behavior Science, School of Basic Medicine, Jinan University, Guangzhou 510632, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Medical Imaging Center, First Affiliated Hospital of Jinan University, Guangzhou 510632, China.'}, {'ForeName': 'Kwok-Fai', 'Initials': 'KF', 'LastName': 'So', 'Affiliation': 'Guangdong-Hongkong-Macau Institute of CNS Regeneration, Ministry of Education CNS Regeneration Collaborative Joint Laboratory, Jinan University, Guangzhou 510632, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510530, China; Center for Brain Science and Brain-Inspired Intelligence, Guangdong-Hong Kong-Macao Greater Bay Area, Guangzhou 510515, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong 226001, China.'}, {'ForeName': 'Chaoran', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': 'Guangdong-Hongkong-Macau Institute of CNS Regeneration, Ministry of Education CNS Regeneration Collaborative Joint Laboratory, Jinan University, Guangzhou 510632, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510530, China; Center for Brain Science and Brain-Inspired Intelligence, Guangdong-Hong Kong-Macao Greater Bay Area, Guangzhou 510515, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong 226001, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Tao', 'Affiliation': 'Department of Public Health and Preventive Medicine, School of Basic Medicine, Jinan University, Guangzhou 510632, China; Division of Medical Psychology and Behavior Science, School of Basic Medicine, Jinan University, Guangzhou 510632, China; Center for Brain Science and Brain-Inspired Intelligence, Guangdong-Hong Kong-Macao Greater Bay Area, Guangzhou 510515, China. Electronic address: taoqian16@jnu.edu.cn.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.055']
1506,32871534,Neurocognitive performance of repeated versus single intravenous subanesthetic ketamine in treatment resistant depression.,"BACKGROUND


Ketamine demonstrated rapid antidepressant effects in treatment-resistant depression (TRD). However, evaluation of ketamine's neurocognitive effect in TRD is unclear. We aim to (1) characterize baseline neurocognitive performance as a predictor of the change in severity of depressive symptoms over time, and (2) investigate the association of six versus single intravenous (IV) ketamine and neurocognitive changes from baseline to the end of treatment.
METHODS


Subjects with TRD were randomized to receive either five IV midazolam followed by a single IV ketamine or six IV ketamine during a 12-day period. Depression symptom assessments occurred prior and 24 h after infusion days using the Montgomery-Åsberg Depression Rating Scale. Neurocognitive tasks were designed to test attention, memory, speed of processing, and set shifting using the CogState battery at baseline and at the end of treatment.
RESULTS


Better complex working memory at baseline predicted improvement in MADRS scores of ketamine (vs midazolam) after 5 infusions. Most, but not all, neurocognitive functions remained stable or improved after repeated or single ketamine. There was a greater differential effect of treatment on speed of processing, set shifting, and spatial working memory that favors subjects in the six ketamine group. These cognitive improvements from baseline to the end of treatment were robust when controlling for age and changes in depression severity.
CONCLUSION


The study suggests that six IV ketamine compared to single IV ketamine has a mood independent procognitive effect among TRD patients. Large scale studies are needed to confirm whether ketamine enhances cognitive function in TRD.",2020,"There was a greater differential effect of treatment on speed of processing, set shifting, and spatial working memory that favors subjects in the six ketamine group.","['Subjects with TRD', 'TRD patients']","['Ketamine', 'single intravenous (IV) ketamine', 'ketamine', 'subanesthetic ketamine', 'ketamine or six IV ketamine', 'midazolam']","['speed of processing, set shifting, and spatial working memory', 'neurocognitive functions', 'Montgomery-Åsberg Depression Rating Scale', 'MADRS scores', 'Neurocognitive performance', 'Depression symptom assessments']","[{'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.07502,"There was a greater differential effect of treatment on speed of processing, set shifting, and spatial working memory that favors subjects in the six ketamine group.","[{'ForeName': 'Paulo R', 'Initials': 'PR', 'LastName': 'Shiroma', 'Affiliation': 'Geriatric Psychiatrist, Minneapolis VA Health Care System, Mental Health Service Line; and Assistant Professor, Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA. Electronic address: paulo.shiroma@va.gov.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Thuras', 'Affiliation': 'Statistician/Research Methodologist, Minneapolis VA Health Care System, Mental Health Service Line; and Assistant Professor/Research Associate, Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Wels', 'Affiliation': 'Staff Anesthesiologist, Minneapolis VA Health Care System, Mental Health Service Line; and Clinical Instructor, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'C Sophia', 'Initials': 'CS', 'LastName': 'Albott', 'Affiliation': 'Assistant Professor, Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Erbes', 'Affiliation': 'Staff Psychologist, Minneapolis VA Health Care System, Mental Health Service Line; and Associate Professor of Psychiatry, University of Minnesota Medical School, Minneapolis, MN.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Tye', 'Affiliation': 'Senior Research Fellow, Queensland Brain Institute, The University of Queensland, Queensland, Australia; Assistant Professor Psychiatry, Psychology and Pharmacology Translational Neuroscience Laboratory, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kelvin O', 'Initials': 'KO', 'LastName': 'Lim', 'Affiliation': 'Drs. T.J. and Ella M. Arneson Land-Grant Chair in Human Behavior, Professor of Psychiatry, Vice Chair for Research Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.058']
1507,32871535,Effect of adjunctive pimavanserin on suicidal ideation in patients with major depression: Analysis of the CLARITY study.,"BACKGROUND


Up to 15% of patients with major depressive disorder (MDD) attempt suicide and up to 2% complete suicide. This was a post-hoc analysis aimed to evaluate the risk of suicide ideation and behavior associated with adjunctive pimavanserin treatment in adults with MDD.
METHODS


CLARITY was a randomized, double-blind, placebo-controlled study in patients with MDD and an inadequate response to a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI). For this post-hoc analysis, the primary endpoint was mean change from baseline for HAMD item 3 (suicide). The incidence of suicidal ideation or behavior was also assessed from the Columbia-Suicide Severity Rating Scale (C-SSRS) and reports of adverse events.
RESULTS


During Stage 1, LS mean change for HAMD Item 3 was reduced from baseline at each week with pimavanserin with a significant difference between pimavanserin and placebo at Week 3 (p=0.012, effect size: 0.431). At any post-baseline assessment, suicidal ideation on the C-SSRS was reported in 28 (18.1%) of patients with placebo and 9 (17.3%) with pimavanserin during Stage 1 and in 7 (20.7%) with placebo and 4 (13.8%) with pimavanserin during Stage 2. No events of suicidal behavior were observed with either placebo or pimavanserin.
LIMITATIONS


The post hoc nature, exclusion of patients with any history of suicide from the primary study, and the small number of patients who demonstrated evidence of suicidal ideation.
CONCLUSIONS


Adjunctive pimavanserin was not associated with an increase in suicidal ideation in patients with MDD. Further study is needed to verify these results.",2020,"During Stage 1, LS mean change for HAMD Item 3 was reduced from baseline at each week with pimavanserin with a significant difference between pimavanserin and placebo at Week 3 (p=0.012, effect size: 0.431).","['patients with major depressive disorder (MDD', 'patients with MDD', 'adults with MDD', 'patients with major depression', 'patients with MDD and an inadequate response to a']","['adjunctive pimavanserin', 'placebo', 'selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI']","['LS mean change for HAMD Item 3', 'incidence of suicidal ideation or behavior', 'suicidal ideation on the C-SSRS', 'Columbia-Suicide Severity Rating Scale (C-SSRS) and reports of adverse events', 'suicidal ideation', 'suicidal behavior']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}]","[{'cui': 'C1722267', 'cui_str': 'pimavanserin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C1319313', 'cui_str': 'Norepinephrine reuptake inhibitor-containing product'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}]",,0.255115,"During Stage 1, LS mean change for HAMD Item 3 was reduced from baseline at each week with pimavanserin with a significant difference between pimavanserin and placebo at Week 3 (p=0.012, effect size: 0.431).","[{'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: rcshelton@uabmc.edu.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Dirks', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Stankovic', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.051']
1508,32881945,"Effect of complementary feeding behavior change communication delivered through community-level actors on dietary adequacy of infants in rural communities of West Gojjam Zone, Northwest Ethiopia: A cluster-randomized controlled trial.","BACKGROUND


Attaining the recommended level of adequacy of the infant's diet remains a serious challenge in most developing countries. Complementary foods, particularly in developing countries, are inadequate in quality and quantity that can result in adverse health and nutrition consequences in infants. This could be not only because of lack of food but also associated with caregiver's poor knowledge, harmful cultural norms and behaviors on infant feeding. The promotion of optimal complementary feeding through behavior change interventions is a global health priority. However, many of the interventions targeted only mothers/caregivers of infants, and studies that engaged other family members are limited worldwide. Moreover, such interventions are scarce in developing countries, including Ethiopia. This trial aimed to evaluate the effectiveness of complementary feeding behavior change communication delivered through community-level actors on the dietary adequacy of infants.
METHODS


We conducted a cluster-randomized controlled trial in rural communities of West Gojjam Zone, Northwest Ethiopia. Trial participants in the intervention clusters received complementary feeding behavior change communication for 9 months whereas those in the control clusters received only the usual care. Trained women development army leaders delivered the intervention. A pre-tested, structured interviewer-administered questionnaire was used for data collection. Generalized estimating equations regression analyses adjusted for baseline covariates and clustering were used to test the intervention effects.
RESULTS


The intervention showed positive statistically significant effects on the consumption of dairy products [RR = 1.8; 95% CI: 1.04-3.13], eggs [RR = 3; 95% CI: 1.35-6.56], vitamin A-rich fruits and vegetables [RR = 2.7; 95% CI: 1.17-6.1], other fruits and vegetables [RR = 5; 95% CI: 2.49-10.58] and animal-source foods [RR = 2; 95% CI: 1.39-2.87]. The proportions of infants who achieved minimum dietary diversity [RR = 3; 95% CI: 1.34, 7.39], minimum meal frequency [RR = 2.4; 95% CI: 1.37-4.29], and minimum acceptable diet [RR = 2.7; 95% CI: 1.13-7.23] were significantly higher in the intervention as compared to control groups.
CONCLUSIONS


Complementary feeding behavior change communication delivered through community-level actors significantly improved the dietary adequacy of infants.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03488680. Registered 5 April 2018- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03488680.",2020,"The intervention showed positive statistically significant effects on the consumption of dairy products [RR = 1.8; 95% CI: 1.04-3.13], eggs [RR = 3; 95% CI: 1.35-6.56], vitamin A-rich fruits and vegetables [RR = 2.7; 95% CI: 1.17-6.1], other fruits and vegetables [RR = 5; 95% CI: 2.49-10.58] and animal-source foods [RR = 2; 95% CI: 1.39-2.87].","['infants\xa0in rural communities of West Gojjam Zone, Northwest Ethiopia', 'rural communities of West Gojjam Zone, Northwest Ethiopia', 'Trained women development army leaders', 'infants']","['complementary feeding behavior change communication', 'complementary feeding behavior change communication delivered through community-level actors']","['consumption of dairy products', 'minimum meal frequency']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0335083', 'cui_str': 'Actor'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0010947', 'cui_str': 'Dairy foods'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.211057,"The intervention showed positive statistically significant effects on the consumption of dairy products [RR = 1.8; 95% CI: 1.04-3.13], eggs [RR = 3; 95% CI: 1.35-6.56], vitamin A-rich fruits and vegetables [RR = 2.7; 95% CI: 1.17-6.1], other fruits and vegetables [RR = 5; 95% CI: 2.49-10.58] and animal-source foods [RR = 2; 95% CI: 1.39-2.87].","[{'ForeName': 'Chalachew', 'Initials': 'C', 'LastName': 'Abiyu', 'Affiliation': 'School of Medicine, College of Medicine and Health Sciences, Wollo University, Dessie, Ethiopia.'}, {'ForeName': 'Tefera', 'Initials': 'T', 'LastName': 'Belachew', 'Affiliation': 'Faculty of Public Health, Department of Nutrition and Dietetics, Jimma University, Jimma, Ethiopia.'}]",PloS one,['10.1371/journal.pone.0238355']
1509,32882517,"Improving abnormal gait patterns by using a gait exercise assist robot (GEAR) in chronic stroke subjects: A randomized, controlled, pilot trial.","BACKGROUND


Although the Gait Exercise Assist Robot (GEAR) has been reported to effectively improve gait of hemiplegic patients, no study has investigated its use in chronic stroke patients. It is possible to facilitate gait reorganization by gait training with less compensation using the GEAR even in chronic stroke patients.
RESEARCH QUESTION


What are the effects of GEAR training on the abnormal gait patterns of chronic stroke subjects?
METHODS


Subjects were randomly assigned to either the GEAR group (n = 8) or the treadmill group (n = 11). Each group underwent 20 sessions (40 min/day, 5 days/week). The changes in the 10 types of abnormal gait patterns were evaluated using a three-dimensional motion analysis system and the Global Rating of Change (GRC) scale before and after the intervention, and at 1-month and 3-month follow-up assessment.
RESULTS


In the GEAR group, hip hiking at a 1-month follow-up assessment was markedly lesser than that before the intervention, and the excessive hip external rotation at 3-month follow-up assessment was notably lesser than that after the intervention, but the change in excessive hip external rotation was in the normal range. In the treadmill group, knee extensor thrust at a 1-month follow-up assessment was strikingly lesser than that before the intervention, but the difference was in the normal range. In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention. But, in the treadmill group, only the GRC scale score at a 1-month follow-up assessment was visibly higher than that before the intervention.
SIGNIFICANCE


Gait training using the GEAR may be more effective than treadmill-training in improving the swing phase in chronic stroke subjects.",2020,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","['chronic stroke patients', 'chronic stroke subjects', 'Subjects']","['GEAR', 'Gait Exercise Assist Robot (GEAR', 'GEAR training', 'gait exercise assist robot (GEAR', 'Gait training']","['excessive hip external rotation', 'hip hiking', 'Global Rating of Change (GRC) scale', 'GRC scale score', 'GRC scale scores']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C4255280', 'cui_str': 'Hiking'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0196297,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","[{'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Ogino', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan. Electronic address: ogino0327@gmail.com.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kanata', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Uegaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Tatuya', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Katuhisa', 'Initials': 'K', 'LastName': 'Morisaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Nakano', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Domen', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.017']
1510,32885419,"Intake of okara soup for 2 weeks for breakfast improved defecation habits in young Japanese women with self-reported constipation: A randomized, double-blind, placebo-controlled, intervention study.","Okara is a byproduct of soymilk manufacturing and a rich source of protein and dietary fiber. We investigated whether okara intake improves the habit of defecation in young Japanese women (n = 52) with self-reported constipation. Subjects were categorized into placebo and test groups, who ingested soymilk (0.1 g fiber/meal) and okara (4.1 g fiber/meal) soups, respectively, every day for breakfast, for 2 weeks. Subjects' body composition, bowel movement frequency per week, and constipation assessment scale (CAS) and brief-type self-administered diet history questionnaire scores were assessed at baseline and after the intervention (Analysis 1). Further, subjects' bowel movement frequency per week and CAS scores were assessed during the 2-week follow-up (Analysis 2). There were no significant differences in age, anthropometric characteristics, nutrients intake, frequency of bowel movements per week, and total CAS scores between the placebo and test groups at baseline. After intervention, the total CAS score was significantly lower in the test group than in the placebo group. Moreover, the difference in the total CAS scores between baseline and after intervention was lower in the test group than in the placebo group, although not significant. The weekly frequency of bowel movement significantly increased for both placebo and test groups. The test group reported reduced abdominal bloating 2 weeks after the intervention, but the placebo group did not. The findings suggest that okara is effective in increasing the frequency of bowel movements and improving defecation habit in young women with self-reported constipation. PRACTICAL APPLICATION: Okara is an effective food to increase the frequency of bowel movements and to improve defecation habits in young women with self-reported constipation.",2020,The findings suggest that okara is effective in increasing the frequency of bowel movements and improving defecation habit in young women with self-reported constipation.,"['young Japanese women with self-reported constipation', 'young Japanese women (n = 52) with self-reported constipation', 'young women with self-reported constipation']","['placebo', 'okara intake']","['CAS scores', 'abdominal bloating', 'frequency of bowel movements', 'total CAS scores', 'habit of defecation', 'weekly frequency of bowel movement', 'age, anthropometric characteristics, nutrients intake, frequency of bowel movements per week, and total CAS scores', 'defecation habits', ""Subjects' body composition, bowel movement frequency per week, and constipation assessment scale (CAS) and brief-type self-administered diet history questionnaire scores"", 'frequency of bowel movements and improving defecation habit', 'total CAS score']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0426642', 'cui_str': 'Frequency of bowel action'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",52.0,0.0744362,The findings suggest that okara is effective in increasing the frequency of bowel movements and improving defecation habit in young women with self-reported constipation.,"[{'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Maeta', 'Affiliation': ""Department of Food Science and Nutrition, School of Food Science and Nutrition, Mukogawa Women's University, 6-46, Ikebiraki-cho, Nishinomiya, Hyogo, 663-8558, Japan.""}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Katsukawa', 'Affiliation': 'Product Development Division, Kikkoman Food Products Company, 250, Noda, Noda, Chiba, 278-0037, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Inomoto', 'Affiliation': 'Product Development Division, Kikkoman Food Products Company, 250, Noda, Noda, Chiba, 278-0037, Japan.'}, {'ForeName': 'Yaeko', 'Initials': 'Y', 'LastName': 'Hayase', 'Affiliation': 'Product Development Division, Kikkoman Food Products Company, 250, Noda, Noda, Chiba, 278-0037, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': ""Department of Food Science and Nutrition, School of Food Science and Nutrition, Mukogawa Women's University, 6-46, Ikebiraki-cho, Nishinomiya, Hyogo, 663-8558, Japan.""}]",Journal of food science,['10.1111/1750-3841.15392']
1511,32885440,"Effects of probiotic and prebiotic supplementation on metabolic parameters, liver aminotransferases, and systemic inflammation in nonalcoholic fatty liver disease: A randomized clinical trial.","This study aimed to evaluate the clinical efficacy of probiotic and prebiotic supplementation on the metabolic parameters, liver enzymes, and inflammation in patients with nonalcoholic fatty liver disease (NAFLD). In this study, patients with NAFLD were assigned to receive either probiotic capsule + placebo of prebiotic (probiotic group), oligofructose + placebo of probiotic (prebiotic group), or placebo of probiotic + placebo of prebiotic (control group) for 12 weeks. All participants followed a weight loss diet and physical activity recommendation during intervention. Anthropometric measurements decreased in all three groups, but there was no significant difference among groups. Probiotic supplementation was able to decrease triglyceride, alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyltransferase (GGT), and alkaline phosphatase compared to control group. The serum levels of triglyceride, total and low-density lipoprotein cholesterol, ALT, AST, and GGT differed significantly in prebiotic group in comparison to the placebo. High-sensitive C-reactive protein significantly decreased within all groups; however, there was no significant difference among groups after intervention. Probiotic and prebiotic may be beneficial in improving liver enzymes and lipid profile in patients with NAFLD.",2020,"Probiotic supplementation was able to decrease triglyceride, alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyltransferase (GGT), and alkaline phosphatase compared to control group.","['patients with NAFLD', 'nonalcoholic fatty liver disease', 'patients with nonalcoholic fatty liver disease (NAFLD']","['probiotic capsule + placebo of prebiotic (probiotic group), oligofructose + placebo of probiotic (prebiotic group), or placebo of probiotic + placebo of prebiotic (control group', 'probiotic and prebiotic supplementation', 'Probiotic supplementation', 'placebo']","['metabolic parameters, liver aminotransferases, and systemic inflammation', 'High-sensitive C-reactive protein', 'Anthropometric measurements', 'serum levels of triglyceride, total and low-density lipoprotein cholesterol, ALT, AST, and GGT', 'triglyceride, alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyltransferase (GGT), and alkaline phosphatase', 'metabolic parameters, liver enzymes, and inflammation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0907858', 'cui_str': 'oligofructose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0678107', 'cui_str': 'Glutamyl transferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}]",,0.105665,"Probiotic supplementation was able to decrease triglyceride, alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyltransferase (GGT), and alkaline phosphatase compared to control group.","[{'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Behrouz', 'Affiliation': 'Gastroenterology and Hepatology Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Naheed', 'Initials': 'N', 'LastName': 'Aryaeian', 'Affiliation': 'Research Center for Environmental Health Technology, Iran University of Medical Sciences and Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Zahedi', 'Affiliation': 'Gastroenterology and Hepatology Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Jazayeri', 'Affiliation': 'Research Center for Prevention of Cardiovascular Disease, Iran University of Medical Sciences, Tehran, Iran.'}]",Journal of food science,['10.1111/1750-3841.15367']
1512,32889444,Evaluating substance use treatment efficacy for younger and older adults.,"The purpose of this study was to examine the differential efficacy of aftercare substance use treatments for younger (below 40, n = 107) versus older (40+, n = 114) adults (N = 221), using data from a randomized controlled trial in a community-based substance abuse treatment center. The younger adult sample had a mean age of 28.9 while the older adult sample had a mean age of 48.1. Primary outcomes were rates of abstinence and percent use days at 1-year follow-up. Outcomes were compared between standard cognitive behavioral relapse prevention (RP), Mindfulness-Based Relapse Prevention (MBRP), and 12-step-based treatment as usual (TAU). Results showed significant differences by treatment in the older, but not in younger, subsample of participants. Specifically, the older participants in MBRP had significantly higher abstinence rates compared with those in TAU. Further, the older individuals in MBRP had a significantly lower percent of days on which they used compared with those in TAU and RP. Overall, findings suggest that age group may impact aftercare treatment substance use outcomes.",2020,"Results showed significant differences by treatment in the older, but not in younger, subsample of participants.","['younger adult sample had a mean age of 28.9 while the older adult sample had a mean age of 48.1', 'younger (below 40, n\xa0=\xa0107) versus older (40+, n\xa0=\xa0114) adults (N\xa0=\xa0221), using data from a randomized controlled trial in a community-based substance abuse treatment center', 'younger and older adults']",['aftercare substance'],"['rates of abstinence and percent use days at 1-year follow-up', 'abstinence rates', 'standard cognitive behavioral relapse prevention (RP), Mindfulness-Based Relapse Prevention (MBRP), and 12-step-based treatment as usual (TAU']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079256', 'cui_str': 'Substance abuse treatment center'}]","[{'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0439861', 'cui_str': 'Substance'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",114.0,0.101879,"Results showed significant differences by treatment in the older, but not in younger, subsample of participants.","[{'ForeName': 'Tyree', 'Initials': 'T', 'LastName': 'Dingle', 'Affiliation': 'School of Graduate Psychology, Pacific University, United States. Electronic address: ding7624@pacificu.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bowen', 'Affiliation': 'School of Graduate Psychology, Pacific University, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106618']
1513,32889494,"The closer you feel, the more you care: Positive associations between closeness, pain intensity rating, empathic concern and personal distress to someone in pain.","Previous research revealed inconsistent findings regarding affective responses when facing someone in pain (i.e., empathic concern and/or personal distress). In this paper, we suggest that the degree of closeness between the observer and the person in pain may account for these contradictory results, such that greater closeness towards this person leads to higher personal distress. To test this hypothesis, we induced either low or high closeness with a confederate in 69 randomly assigned participants. Following the closeness induction, participants evaluated their affective responses (empathic concern and personal distress) and rated the confederate's pain intensity after watching the confederate undergoing a painful cold pressure task. Results showed that, despite the non-significant effect of closeness induction, closeness across both conditions (low and high) was positively correlated with pain intensity rating, empathic concern and personal distress. This study thus suggests that closeness is associated with higher cognitive and affective responses to a person in pain.",2020,"Results showed that, despite the non-significant effect of closeness induction, closeness across both conditions (low and high) was positively correlated with pain intensity rating, empathic concern and personal distress.",['69 randomly assigned participants'],['confederate undergoing a painful cold pressure task'],"[""affective responses (empathic concern and personal distress) and rated the confederate's pain intensity"", 'pain intensity rating, empathic concern and personal distress to someone in pain', 'pain intensity rating, empathic concern and personal distress']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",69.0,0.0551593,"Results showed that, despite the non-significant effect of closeness induction, closeness across both conditions (low and high) was positively correlated with pain intensity rating, empathic concern and personal distress.","[{'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Grynberg', 'Affiliation': 'Univ. Lille, CNRS, UMR 9193 - SCALab - Sciences Cognitives et Sciences Affectives, F-59000 Lille, France; Institut Universitaire de France, Paris, France. Electronic address: Delphine.Grynberg@univ-lille.fr.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Konrath', 'Affiliation': 'Lilly Family School of Philanthropy, Indiana University, Indianapolis, IN 46202, United States of America.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103175']
1514,32886811,Cystoscopy with antibiotic irrigation during pelvic reconstruction and minimally invasive gynecologic surgery: A double-blind randomized controlled trial.,"AIMS


After pelvic reconstructive surgery, the risk of postoperative urinary tract infection (UTI) is significant; intraoperative cystoscopy may contribute to this risk. Intravesical antibiotics are used in the ambulatory setting and may be applied to the surgical arena. Our objective was to evaluate the efficacy of antibiotic irrigation during intraoperative cystoscopy to prevent postoperative UTI.
METHODS


This double-blind randomized controlled trial enrolled 216 women undergoing cystoscopy with elective surgery for pelvic organ prolapse, stress urinary incontinence, or laparoscopic gynecologic surgery at an academic medical center 2016-2019. Participants were randomized to cystoscopic irrigation fluid type: normal saline (control) or 200,000 U polymyxin B + 40 mg neomycin solution in normal saline (antibiotic). Patients and providers who treated UTIs were blinded. The primary outcome was treatment of UTI within 6 weeks postoperatively, defined as positive culture or treatment for a symptomatic UTI. χ 2  and multivariable logistic regression analyses were performed.
RESULTS


We enrolled 216 women: 111 control (51.4%) and 105 antibiotic (48.6%). Mean age was 51.6 years. Groups were well matched in medical comorbidities and surgery type. Primary vaginal surgery was most common (n = 127, 58.8%). Overall, 10.7% of patients developed a postoperative UTI with no difference in incidence between groups: 9.9% of control (n = 11, 95% confidence interval [CI]: 4.0%-16.0%) versus 11.4% of antibiotic subjects (n = 12, 95% CI: 5.0%-18.0%), on χ 2  (p = .718) and logistic regression analysis (adjusted odds ratio, 1.3; CI: 0.53-3.16; p = .569).
CONCLUSION


When cystoscopy is performed during elective pelvic surgery, use of antibiotic irrigation does not impact the rate of postoperative UTI.",2020,"When cystoscopy is performed during elective pelvic surgery, use of antibiotic irrigation does not impact the rate of postoperative UTI.","['Patients and providers who treated UTIs were blinded', 'Mean age was 51.6 years', '216 women undergoing cystoscopy with elective surgery for pelvic organ prolapse, stress urinary incontinence, or laparoscopic gynecologic surgery at an academic medical center 2016-2019', 'We enrolled 216 women: 111 control (51.4%) and 105 antibiotic (48.6']","['cystoscopic irrigation fluid type: normal saline (control) or 200,000 U polymyxin B\u2009+\u200940 mg neomycin solution in normal saline (antibiotic', 'Intravesical antibiotics', 'pelvic reconstruction and minimally invasive gynecologic surgery', 'antibiotic irrigation', 'Cystoscopy with antibiotic irrigation']","['UTI within 6 weeks postoperatively, defined as positive culture or treatment for a symptomatic UTI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032535', 'cui_str': 'Polymyxin B'}, {'cui': 'C0027603', 'cui_str': 'Neomycin'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",216.0,0.725078,"When cystoscopy is performed during elective pelvic surgery, use of antibiotic irrigation does not impact the rate of postoperative UTI.","[{'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Slopnick', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Welles Henderson', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Chapman', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Sheyn', 'Affiliation': 'Urology Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Sherif A', 'Initials': 'SA', 'LastName': 'El-Nashar', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Petrikovets', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pollard', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Mangel', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center, Cleveland, Ohio, USA.'}]",Neurourology and urodynamics,['10.1002/nau.24499']
1515,32887287,Effects of Thoracic Mobilization and Extension Exercise on Thoracic Alignment and Shoulder Function in Patients with Subacromial Impingement Syndrome: A Randomized Controlled Pilot Study.,"Introduction:  Thoracic kyphosis commonly occurs in subacromial impingement syndrome. This pilot study investigated the effect of thoracic joint mobilization and extension exercise on improving thoracic alignment and shoulder function.  Methods:  In total, 30 patients with subacromial impingement syndrome were recruited and randomly assigned to three groups, the joint mobilization group ( n  = 10), exercise group ( n  = 10), and combination group ( n  = 10). After four weeks of treatment, the measured outcomes included thoracic kyphosis using a manual inclinometer; pectoralis major (PM) and upper trapezius (UT) muscle tone and stiffness using the MyotonPRO ® ; affected side passive range of motion (ROM) using the goniometer (flexion, abduction, medial rotation, and lateral rotation); and shoulder pain and disability index (SPADI).  Results:  All three groups had significant improvements in all variables ( p  < 0.05). Thoracic kyphosis; UT muscle tone; and flexion, medial rotation, and lateral rotation ROM and SPADI were all significantly improved in the combination group compared to the mobilization and exercise groups ( p  < 0.05).  Conclusions:  The combination therapy of thoracic mobilization and extension exercise can be regarded as a promising method to improve thoracic alignment and shoulder function in patients with subacromial impingement syndrome.",2020,All three groups had significant improvements in all variables ( p  < 0.05).,"['30 patients with subacromial impingement syndrome', 'Patients with Subacromial Impingement Syndrome', 'subacromial impingement syndrome', 'patients with subacromial impingement syndrome']","['thoracic joint mobilization and extension exercise', 'joint mobilization group', 'Thoracic Mobilization and Extension Exercise', 'thoracic mobilization and extension exercise', 'exercise group']","['thoracic kyphosis using a manual inclinometer; pectoralis major (PM) and upper trapezius (UT) muscle tone and stiffness using the MyotonPRO ® ; affected side passive range of motion (ROM) using the goniometer (flexion, abduction, medial rotation, and lateral rotation); and shoulder pain and disability index (SPADI', 'flexion, medial rotation, and lateral rotation ROM and SPADI', 'Thoracic Alignment and Shoulder Function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0231588', 'cui_str': 'Physiatric mobilization of joint'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",30.0,0.0817838,All three groups had significant improvements in all variables ( p  < 0.05).,"[{'ForeName': 'Shin Jun', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Gangdong University, 278, Daehak-gil, Gamgok-myeon, Eumseong-gun, Chungcheongbuk-do 27600, Korea.'}, {'ForeName': 'Seok Hyeon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, General Graduate School, Yongin University, 134, Yongindaehak-ro, Cheoin-gu, Yongin-si, Gyeonggi-do 17092, Korea.'}, {'ForeName': 'Soon Hee', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Yongin University, 134, Yongindaehak-ro, Cheoin-gu, Yongin-si, Gyeonggi-do 17092, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8030316']
1516,32891212,"Once-daily, subcutaneous vosoritide therapy in children with achondroplasia: a randomised, double-blind, phase 3, placebo-controlled, multicentre trial.","BACKGROUND


There are no effective therapies for achondroplasia. An open-label study suggested that vosoritide administration might increase growth velocity in children with achondroplasia. This phase 3 trial was designed to further assess these preliminary findings.
METHODS


This randomised, double-blind, phase 3, placebo-controlled, multicentre trial compared once-daily subcutaneous administration of vosoritide with placebo in children with achondroplasia. The trial was done in hospitals at 24 sites in seven countries (Australia, Germany, Japan, Spain, Turkey, the USA, and the UK). Eligible patients had a clinical diagnosis of achondroplasia, were ambulatory, had participated for 6 months in a baseline growth study and were aged 5 to less than 18 years at enrolment. Randomisation was done by means of a voice or web-response system, stratified according to sex and Tanner stage. Participants, investigators, and trial sponsor were masked to group assignment. Participants received either vosoritide 15·0 μg/kg or placebo, as allocated, for the duration of the 52-week treatment period administered by daily subcutaneous injections in their homes by trained caregivers. The primary endpoint was change from baseline in mean annualised growth velocity at 52 weeks in treated patients as compared with controls. All randomly assigned patients were included in the efficacy analyses (n=121). All patients who received one dose of vosoritide or placebo (n=121) were included in the safety analyses. The trial is complete and is registered, with EudraCT, number, 2015-003836-11.
FINDINGS


All participants were recruited from Dec 12, 2016, to Nov 7, 2018, with 60 assigned to receive vosoritide and 61 to receive placebo. Of 124 patients screened for eligibility, 121 patients were randomly assigned, and 119 patients completed the 52-week trial. The adjusted mean difference in annualised growth velocity between patients in the vosoritide group and placebo group was 1·57 cm/year in favour of vosoritide (95% CI [1·22-1·93]; two-sided p<0·0001). A total of 119 patients had at least one adverse event; vosoritide group, 59 (98%), and placebo group, 60 (98%). None of the serious adverse events were considered to be treatment related and no deaths occurred.
INTERPRETATION


Vosoritide is an effective treatment to increase growth in children with achondroplasia. It is not known whether final adult height will be increased, or what the harms of long-term therapy might be.
FUNDING


BioMarin Pharmaceutical.",2020,"None of the serious adverse events were considered to be treatment related and no deaths occurred.
","['All participants were recruited from Dec 12, 2016, to Nov 7, 2018, with 60 assigned to receive vosoritide and 61 to receive', 'children with achondroplasia', 'hospitals at 24 sites in seven countries (Australia, Germany, Japan, Spain, Turkey, the USA, and the UK', '119 patients had at least one adverse event; vosoritide group, 59 (98%), and', 'Eligible patients had a clinical diagnosis of achondroplasia, were ambulatory, had participated for 6 months in a baseline growth study and were aged 5 to less than 18 years at enrolment', '124 patients screened for eligibility, 121 patients were randomly assigned, and 119 patients completed the 52-week trial']","['vosoritide with placebo', 'placebo', 'vosoritide or placebo', 'subcutaneous vosoritide therapy', 'vosoritide', 'vosoritide 15·0 μg/kg or placebo']","['annualised growth velocity', 'mean annualised growth velocity', 'growth velocity']","[{'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4519745', 'cui_str': 'vosoritide'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001080', 'cui_str': 'Achondroplasia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4519745', 'cui_str': 'vosoritide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",121.0,0.793501,"None of the serious adverse events were considered to be treatment related and no deaths occurred.
","[{'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Savarirayan', 'Affiliation': ""Murdoch Children's Research Institute, Royal Children's Hospital, and University of Melbourne, Parkville, VIC, Australia. Electronic address: ravi.savarirayan@vcgs.org.au.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Tofts', 'Affiliation': ""Kids Rehab, The Children's Hospital at Westmead, Westmead, NSW, Australia.""}, {'ForeName': 'Melita', 'Initials': 'M', 'LastName': 'Irving', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, Evelina Children's Hospital, London, UK.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wilcox', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Bacino', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hoover-Fong', 'Affiliation': 'McKusick-Nathans Department of Genetic Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Rosendo', 'Initials': 'R', 'LastName': 'Ullot Font', 'Affiliation': 'Hospital Sant Joan de Déu, Barcelona, Spain.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Harmatz', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland, Oakland, CA, USA.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Rutsch', 'Affiliation': ""Department of General Pediatrics, Muenster University Children's Hospital, Muenster, Germany.""}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Bober', 'Affiliation': 'Nemours-Alfred I. du Pont Hospital for Children, Wilmington, DE, USA.'}, {'ForeName': 'Lynda E', 'Initials': 'LE', 'LastName': 'Polgreen', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Ginebreda', 'Affiliation': 'Hospital Universitario Quirón Dexeus, Barcelona, Spain.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Mohnike', 'Affiliation': 'Otto-von-Guericke-Universität, Magdeburg, Germany.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Charrow', 'Affiliation': ""Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hoernschemeyer', 'Affiliation': 'University of Missouri-Columbia, Columbia, MO, USA.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Ozono', 'Affiliation': 'Osaka University Hospital, Osaka, Japan.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Alanay', 'Affiliation': 'Acibadem Mehmet Ali Aydiniar University, School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Arundel', 'Affiliation': ""Sheffield Children's NHS Foundation Trust, Sheffield Children's Hospital, Sheffield, UK.""}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Kagami', 'Affiliation': 'Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Natsuo', 'Initials': 'N', 'LastName': 'Yasui', 'Affiliation': 'Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Klane K', 'Initials': 'KK', 'LastName': 'White', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Saal', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Leiva-Gea', 'Affiliation': 'Hospital Universitario Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Luna-González', 'Affiliation': 'Hospital Universitario Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Mochizuki', 'Affiliation': ""Saitama Children's Hospital, Saitama, Japan.""}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Basel', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Dania M', 'Initials': 'DM', 'LastName': 'Porco', 'Affiliation': 'BioMarin Pharmaceutical, Novato, CA, USA.'}, {'ForeName': 'Kala', 'Initials': 'K', 'LastName': 'Jayaram', 'Affiliation': 'BioMarin Pharmaceutical, Novato, CA, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Fisheleva', 'Affiliation': 'BioMarin (UK), London, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Huntsman-Labed', 'Affiliation': 'BioMarin (UK), London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Day', 'Affiliation': 'BioMarin (UK), London, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31541-5']
1517,32891527,Wearable and interactive technology to share fitness goals results in weight loss but not improved diabetes outcomes.,"BACKGROUND AND PURPOSE


To investigate the effects of adding virtual activity groups to a multicomponent ambulatory activity monitoring intervention in managing chronic conditions such as obesity and type 2 diabetes.
METHODS


We randomized 120 subjects with type 2 diabetes to receive an activity monitor with or without placement into virtual activity groups. We monitored subjects over six months and collected HbA1c, weight, step count, blood pressure, and SF-36 questionnaire data.
RESULTS


All subjects lost significant weight over the course of the study (p = 0.005); however, there was no statistically significant difference in mean weight loss between two groups (p = 0.520). HbA1c decreased in both groups, but was not statistically significant (p = 0.084). Daily step counts were similar between groups (p = 0.633), but both groups did decrease significantly over time (p = 0.004). There was no linear correlation between daily step count and HbA1c (p = 0.609), but there was between daily step count and weight (p = 0.016) although this only accounted for 5.6% of weight loss. There were no significant differences found for blood pressure and Rand SF36 measures between groups or times, or group-time interactions with two exceptions. The SF36 Role functioning/emotional measure showed an interaction between group and time (p = 0.039) and the SF36 Health Change measure had a significant difference due to time irrespective of group (p < 0.0001). Compliance remained high, with 93.8% of subjects actively participating at the conclusion of the study.
CONCLUSIONS


Activity monitoring with in-person goal-setting and scripted feedback over six months was associated with significant weight loss with or without virtual support groups.",2020,The SF36 Role functioning/emotional measure showed an interaction between group and time (p = 0.039) and the SF36 Health Change measure had a significant difference due to time irrespective of group (p < 0.0001).,['120 subjects with type 2 diabetes to receive an'],"['multicomponent ambulatory activity monitoring intervention', 'activity monitor with or without placement into virtual activity groups']","['weight loss', 'Daily step counts', 'collected HbA1c, weight, step count, blood pressure, and SF-36 questionnaire data', 'mean weight loss', 'blood pressure and Rand SF36 measures', 'SF36 Health Change measure', 'HbA1c']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",120.0,0.0201026,The SF36 Role functioning/emotional measure showed an interaction between group and time (p = 0.039) and the SF36 Health Change measure had a significant difference due to time irrespective of group (p < 0.0001).,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lystrup', 'Affiliation': '99th MDG, Nellis Air Force Base, NV, 89191, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Carlsen', 'Affiliation': '99th MDG, Nellis Air Force Base, NV, 89191, USA.'}, {'ForeName': 'Danny J', 'Initials': 'DJ', 'LastName': 'Sharon', 'Affiliation': 'San Antonio, TX, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Crawford', 'Affiliation': '99th MDG, Nellis Air Force Base, NV, 89191, USA. Electronic address: drpaulcrawford@aol.com.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2020.08.006']
1518,32891738,Efficacy and safety of micafungin in empiric and D-index-guided early antifungal therapy for febrile neutropenia; A subgroup analysis of the CEDMIC trial.,"OBJECTIVES


The D-index is defined as the area over the neutrophil curve during neutropenia. The CEDMIC trial confirmed the noninferiority of D-index-guided early antifungal therapy (DET) using micafungin to empirical antifungal therapy (EAT). In this study, we evaluated the efficacy and safety of micafungin in these settings.
METHODS


From the CEDMIC trial, we extracted 67 and 113 patients who received micafungin in the DET and EAT groups, respectively. Treatment success was defined as the fulfilment of all components of a five-part composite end point. Fever resolution was evaluated at seven days after the completion of therapy.
RESULTS


The proportion of high-risk treatments including induction chemotherapy for acute leukemia and allogeneic hematopoietic stem cell transplantation was significantly higher in the DET group than in the EAT group (82.1% vs. 52.2%). The efficacy of micafungin was 68.7% (95%CI: 56.2-79.4) and 79.6% (71.0-86.6) in the DET and EAT groups, respectively. When we focused on high-risk treatments, the efficacy was 69.1% (55.2-80.9%) and 78.0% (65.3-87.7%), respectively (P = 0.30). There was no significant difference in any of the 5 components between the two groups.
CONCLUSIONS


The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.",2020,The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.,"['febrile neutropenia', 'patients undergoing high-risk treatment', '113 patients who received micafungin in the DET and EAT groups, respectively', 'From the CEDMIC trial']",['micafungin'],"['efficacy and safety', 'Efficacy and safety', 'Fever resolution', 'acute leukemia and allogeneic hematopoietic stem cell transplantation']","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1120386', 'cui_str': 'micafungin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]",,0.054726,The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.,"[{'ForeName': 'Shun-Ichi', 'Initials': 'SI', 'LastName': 'Kimura', 'Affiliation': 'Division of Hematology, Jichi Medical University Saitama Medical Center, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Kanda', 'Affiliation': 'Division of Hematology, Jichi Medical University Saitama Medical Center, Japan; Division of Hematology, Department of Medicine, Jichi Medical University, Japan. Electronic address: ycanda-tky@umin.ac.jp.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Iino', 'Affiliation': 'Department of Medical Oncology, Yamanashi Prefectural Central Hospital, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Fukuda', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Japan.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Sakaida', 'Affiliation': 'Department of Hematology, Chiba University Hospital, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Oyake', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Iwate Medical University School of Medicine, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Hematology, Nippon Medical School, Japan.'}, {'ForeName': 'Shin-Ichiro', 'Initials': 'SI', 'LastName': 'Fujiwara', 'Affiliation': 'Division of Hematology, Department of Medicine, Jichi Medical University, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Jo', 'Affiliation': 'Department of Oncology and Hematology / Infection Control Division, Shimane University Hospital, Japan.'}, {'ForeName': 'Akinao', 'Initials': 'A', 'LastName': 'Okamoto', 'Affiliation': 'Department of Hematology, Fujita Health University School of Medicine, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Department of Hematology, Saiseikai Yokohama Nanbu Hospital, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takamatsu', 'Affiliation': 'Division of Medical Oncology, Hematology and Infectious Diseases, Department of Internal Medicine, Fukuoka University Hospital, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Saburi', 'Affiliation': 'Department of Hematology, Oita Prefectural Hospital, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Matsumura', 'Affiliation': 'Department of Hematology and Rheumatology, Kindai University Faculty of Medicine, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yamanouchi', 'Affiliation': 'Departments of Hematology, Clinical Immunology and Infectious Diseases, Ehime University Graduate School of Medicine, Japan.'}, {'ForeName': 'Souichi', 'Initials': 'S', 'LastName': 'Shiratori', 'Affiliation': 'Department of Hematology, Hokkaido University, Faculty of Medicine, Japan.'}, {'ForeName': 'Moritaka', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Hematology, Tokyo Medical University, Japan.'}, {'ForeName': 'Shingen', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Department of Community Medicine and Medical Science, Tokushima University Graduate School of Biomedical Sciences, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'General Medical Research Center, Fukuoka University, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.08.081']
1519,32866432,"Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial.","BACKGROUND


Bortezomib, lenalidomide, and dexamethasone (VRd) is a standard therapy for newly diagnosed multiple myeloma. Carfilzomib, a next-generation proteasome inhibitor, in combination with lenalidomide and dexamethasone (KRd), has shown promising efficacy in phase 2 trials and might improve outcomes compared with VRd. We aimed to assess whether the KRd regimen is superior to the VRd regimen in the treatment of newly diagnosed multiple myeloma in patients who were not being considered for immediate autologous stem-cell transplantation (ASCT).
METHODS


In this multicentre, open-label, phase 3, randomised controlled trial (the ENDURANCE trial; E1A11), we recruited patients aged 18 years or older with newly diagnosed multiple myeloma who were ineligible for, or did not intend to have, immediate ASCT. Participants were recruited from 272 community oncology practices or academic medical centres in the USA. Key inclusion criteria were the absence of high-risk multiple myeloma and an Eastern Cooperative Oncology Group performance status of 0-2. Enrolled patients were randomly assigned (1:1) centrally by use of permuted blocks to receive induction therapy with either the VRd regimen or the KRd regimen for 36 weeks. Patients who completed induction therapy were then randomly assigned (1:1) a second time to either indefinite maintenance or 2 years of maintenance with lenalidomide. Randomisation was stratified by intent for ASCT at disease progression for the first randomisation and by the induction therapy received for the second randomisation. Allocation was not masked to investigators or patients. For 12 cycles of 3 weeks, patients in the VRd group received 1·3 mg/m 2  of bortezomib subcutaneously or intravenously on days 1, 4, 8, and 11 of cycles 1-8, and day 1 and day 8 of cycles nine to twelve, 25 mg of oral lenalidomide on days 1-14, and 20 mg of oral dexamethasone on days 1, 2, 4, 5, 8, 9, 11, and 12. For nine cycles of 4 weeks, patients in the KRd group received 36 mg/m 2  of intravenous carfilzomib on days 1, 2, 8, 9, 15, and 16, 25 mg of oral lenalidomide on days 1-21, and 40 mg of oral dexamethasone on days 1, 8, 15, and 22. The coprimary endpoints were progression-free survival in the induction phase, and overall survival in the maintenance phase. The primary analysis was done in the intention-to-treat population and safety was assessed in patients who received at least one dose of their assigned treatment. The trial is registered with ClinicalTrials.gov, NCT01863550. Study recruitment is complete, and follow-up of the maintenance phase is ongoing.
FINDINGS


Between Dec 6, 2013, and Feb 6, 2019, 1087 patients were enrolled and randomly assigned to either the VRd regimen (n=542) or the KRd regimen (n=545). At a median follow-up of 9 months (IQR 5-23), at a second planned interim analysis, the median progression-free survival was 34·6 months (95% CI 28·8-37·8) in the KRd group and 34·4 months (30·1-not estimable) in the VRd group (hazard ratio [HR] 1·04, 95% CI 0·83-1·31; p=0·74). Median overall survival has not been reached in either group. The most common grade 3-4 treatment-related non-haematological adverse events included fatigue (34 [6%] of 527 patients in the VRd group vs 29 [6%] of 526 in the KRd group), hyperglycaemia (23 [4%] vs 34 [6%]), diarrhoea (23 [5%] vs 16 [3%]), peripheral neuropathy (44 [8%] vs four [<1%]), dyspnoea (nine [2%] vs 38 [7%]), and thromboembolic events (11 [2%] vs 26 [5%]). Treatment-related deaths occurred in two patients (<1%) in the VRd group (one cardiotoxicity and one secondary cancer) and 11 (2%) in the KRd group (four cardiotoxicity, two acute kidney failure, one liver toxicity, two respiratory failure, one thromboembolic event, and one sudden death).
INTERPRETATION


The KRd regimen did not improve progression-free survival compared with the VRd regimen in patients with newly diagnosed multiple myeloma, and had more toxicity. The VRd triplet regimen remains the standard of care for induction therapy for patients with standard-risk and intermediate-risk newly diagnosed multiple myeloma, and is a suitable treatment backbone for the development of combinations of four drugs.
FUNDING


US National Institutes of Health, National Cancer Institute, and Amgen.",2020,"The KRd regimen did not improve progression-free survival compared with the VRd regimen in patients with newly diagnosed multiple myeloma, and had more toxicity.","['Patients who completed induction therapy', '1087 patients', 'Participants were recruited from 272 community oncology practices or academic medical centres in the USA', 'patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE', 'patients with standard-risk and intermediate-risk newly diagnosed multiple myeloma', 'newly diagnosed multiple myeloma in patients who were not being considered for immediate autologous stem-cell transplantation (ASCT', 'newly diagnosed multiple myeloma', 'patients aged 18 years or older with newly diagnosed multiple myeloma who were ineligible for, or did not intend to have, immediate ASCT']","['lenalidomide and dexamethasone', 'KRd', 'lenalidomide and dexamethasone (KRd', 'bortezomib', 'oral dexamethasone', 'indefinite maintenance or 2 years of maintenance with lenalidomide', 'VRd regimen', 'KRd regimen', 'intravenous carfilzomib', 'Carfilzomib or bortezomib', 'induction therapy with either the VRd regimen or the KRd regimen', 'oral lenalidomide', 'Bortezomib, lenalidomide, and dexamethasone (VRd']","['thromboembolic events', 'cardiotoxicity, two acute kidney failure, one liver toxicity, two respiratory failure, one thromboembolic event, and one sudden death', 'diarrhoea', 'intention-to-treat population and safety', 'deaths', 'progression-free survival in the induction phase, and overall survival', 'progression-free survival', 'toxicity', 'dyspnoea', 'median progression-free survival', 'Median overall survival', 'peripheral neuropathy', 'hyperglycaemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0360528', 'cui_str': 'Dexamethasone-containing product in oral dose form'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2001856', 'cui_str': 'carfilzomib'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",1087.0,0.211992,"The KRd regimen did not improve progression-free survival compared with the VRd regimen in patients with newly diagnosed multiple myeloma, and had more toxicity.","[{'ForeName': 'Shaji K', 'Initials': 'SK', 'LastName': 'Kumar', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA. Electronic address: kumar.shaji@mayo.edu.'}, {'ForeName': 'Susanna J', 'Initials': 'SJ', 'LastName': 'Jacobus', 'Affiliation': 'ECOG-ACRIN Biostatistics Center, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Cohen', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'ThedaCare, Appleton, WI, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Callander', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Avina K', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'MOHPA, Burnsville, MN, USA.'}, {'ForeName': 'Terri L', 'Initials': 'TL', 'LastName': 'Parker', 'Affiliation': 'Department of Hematology, Yale University, Hamden, CT, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Kaiser Permanente Lone Tree, Lone Tree, CO, USA.'}, {'ForeName': 'Xuezhong', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Saint Francis Cancer Center, Greenville, NC, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Parsons', 'Affiliation': 'Gundersen Health System, La Crosse, WI, USA.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Illinois Cancer Care, Peoria, IL, USA.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Kapoor', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Rosenberg', 'Affiliation': 'University of California Davis Comprehensive Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Zonder', 'Affiliation': 'Department of Malignant Hematology, Barbara Ann Karmanos Cancer Institute and Wayne State University School of Medicine, Detroit, MI, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Faber', 'Affiliation': 'Oncology Hematology Care, Cincinnati, OH, USA.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Anderson', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest University Health Sciences, Winston-Salem, NC, USA.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30452-6']
1520,32866440,"Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


A phase 2 trial of tocilizumab showed preliminary evidence of efficacy in systemic sclerosis. We assessed skin fibrosis and systemic sclerosis-associated interstitial lung disease (SSc-ILD) in a phase 3 trial to investigate the safety and efficacy of tocilizumab, an anti-interleukin-6 receptor antibody, in the treatment of systemic sclerosis.
METHODS


In this multicentre, randomised, double-blind, placebo-controlled, phase 3 trial, participants were recruited from 75 sites in 20 countries across Europe, North America, Latin America, and Japan. Adults with diffuse cutaneous systemic sclerosis for 60 months or less and a modified Rodnan skin score (mRSS) of 10-35 at screening were randomly assigned (1:1) with a voice-web-response system to receive subcutaneous tocilizumab 162 mg or placebo weekly for 48 weeks, stratified by IL-6 levels; participants and investigators were masked to treatment group. The primary endpoint was the difference in change from baseline to week 48 in mRSS. Percentage of predicted forced vital capacity (FVC% predicted) at week 48, time to treatment failure, and patient-reported and physician-reported outcomes were secondary endpoints. This trial is registered with ClinicalTrials.gov (number NCT02453256) and is closed to accrual.
FINDINGS


Between Nov 20, 2015, and Feb 14, 2017, 210 individuals were randomly assigned to receive tocilizumab (n=104) or placebo (n=106). In the intention-to-treat population, least squares mean [LSM] change from baseline to week 48 in mRSS was -6·14 for tocilizumab and -4·41 for placebo (adjusted difference -1·73 [95% CI -3·78 to 0·32]; p=0·10). The shift in distribution of change from baseline in FVC% predicted at week 48 favoured tocilizumab (van Elteren nominal p=0·002 vs placebo), with a difference in LSM of 4·2 (95% CI 2·0-6·4; nominal p=0·0002), as did time to treatment failure (hazard ratio 0·63 [95% CI 0·37-1·06]; nominal p=0·08). Change in LSM from baseline to week 48 in Health Assessment Questionnaire-Disability Index and in patient-global and physician-global visual analogue scale assessments did not differ between tocilizumab and placebo. In the safety set, infections were the most common adverse events (54 [52%] of 104 participants in the tocilizumab group, 53 [50%] of 106 in the placebo group). Serious adverse events were reported in 13 participants treated with tocilizumab and 18 with placebo, primarily infections (three events, eight events) and cardiac events (two events, seven events).
INTERPRETATION


The primary skin fibrosis endpoint was not met. Findings for the secondary endpoint of FVC% predicted indicate that tocilizumab might preserve lung function in people with early SSc-ILD and elevated acute-phase reactants. Safety was consistent with the known profile of tocilizumab.
FUNDING


F Hoffmann-La Roche Ltd.",2020,Change in LSM from baseline to week 48 in Health Assessment Questionnaire-Disability Index and in patient-global and physician-global visual analogue scale assessments did not differ between tocilizumab and placebo.,"['Adults with diffuse cutaneous systemic sclerosis for 60 months or less and a modified Rodnan skin score (mRSS) of 10-35 at screening', 'systemic sclerosis', 'participants were recruited from 75 sites in 20 countries across Europe, North America, Latin America, and Japan', 'Between Nov 20, 2015, and Feb 14, 2017, 210 individuals']","['voice-web-response system to receive subcutaneous tocilizumab 162 mg or placebo', '1·73', 'tocilizumab and placebo', 'Tocilizumab', 'placebo', 'tocilizumab']","['Health Assessment Questionnaire-Disability Index and in patient-global and physician-global visual analogue scale assessments', 'Serious adverse events', 'cardiac events', 'lung function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1258104', 'cui_str': 'Progressive systemic sclerosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4728203', 'cui_str': 'Modified Rodnan skin score'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",210.0,0.760913,Change in LSM from baseline to week 48 in Health Assessment Questionnaire-Disability Index and in patient-global and physician-global visual analogue scale assessments did not differ between tocilizumab and placebo.,"[{'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA. Electronic address: khannad@med.umich.edu.'}, {'ForeName': 'Celia J F', 'Initials': 'CJF', 'LastName': 'Lin', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Goldin', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kuwana', 'Affiliation': 'Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Allanore', 'Affiliation': 'Paris Descartes University, Paris, France.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Matucci-Cerinic', 'Affiliation': 'University of Florence, Florence, Italy.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Distler', 'Affiliation': 'University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Yoshihito', 'Initials': 'Y', 'LastName': 'Shima', 'Affiliation': 'Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'van Laar', 'Affiliation': 'University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Spotswood', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Wagner', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Siegel', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Jahreis', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Denton', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30318-0']
1521,32876780,Efficacy and safety results from a randomized double-blind study comparing proposed biosimilar ABP 798 with rituximab reference product in subjects with moderate-to-severe rheumatoid arthritis.,"BACKGROUND/OBJECTIVES


ABP 798 is a proposed biosimilar to the originator biologic rituximab, an anti-CD20 monoclonal antibody. This comparative clinical study evaluated the pharmacokinetics (PK), safety, and efficacy of ABP 798 versus rituximab reference product (RP) in patients with moderate-to-severe rheumatoid arthritis (RA).
METHODS


Adults with moderate-to-severe RA with an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs including 1 or more tumor necrosis factor inhibitor therapies (n = 311) received ABP 798, US-sourced rituximab RP (rituximab US), or EU-sourced rituximab RP (rituximab EU) (1000 mg, 2 weeks apart). At week 24, ABP 798- or rituximab EU-treated subjects received a second dose of the same treatment, while rituximab US-treated subjects transitioned to receive ABP 798. The key efficacy endpoint was DAS28-CRP change from baseline at week 24. Other efficacy endpoints included DAS28-CRP at other time points; ACR20, ACR50, and ACR70 criteria; and hybrid ACR. The rituximab RP groups were pooled for all efficacy endpoints since PK equivalence had been established between rituximab US and rituximab EU.
RESULTS


Clinical equivalence between ABP 798 and rituximab RP was established as the 90% confidence interval for DAS28-CRP change from baseline at week 24 fell within the prespecified equivalence margin (- 0.6, 0.6). Safety and immunogenicity profiles of ABP 798 were comparable across treatment groups and not affected by single transition from RP to ABP 798.
CONCLUSIONS


Clinical equivalence in terms of efficacy, safety, and immunogenicity was established between ABP 798 and rituximab RP in this comparative clinical trial in patients with moderate-to-severe RA. Key Points • ABP 798 provided similar efficacy as rituximab reference product (RP) in patients with moderate-severe rheumatoid arthritis. • The safety and immunogenicity profiles for ABP 798 were similar to those for the rituximab RP. • The single transition from rituximab RP to ABP 798 did not show differences in efficacy, safety, or immunogenicity.",2020,"Safety and immunogenicity profiles of ABP 798 were comparable across treatment groups and not affected by single transition from RP to ABP 798.
","['patients with moderate-to-severe RA', 'patients with moderate-severe rheumatoid arthritis', 'Adults with moderate-to-severe RA with an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs including 1 or more tumor necrosis factor inhibitor therapies (n\u2009=\u2009311) received', 'subjects with moderate-to-severe rheumatoid arthritis', 'patients with moderate-to-severe rheumatoid arthritis (RA']","['ABP 798 versus rituximab reference product (RP', 'biosimilar ABP 798 with rituximab reference product', 'rituximab US-treated subjects transitioned to receive ABP 798', 'ABP 798, US-sourced rituximab RP (rituximab US), or EU-sourced rituximab RP (rituximab EU']","['efficacy, safety, and immunogenicity', 'DAS28-CRP at other time points; ACR20, ACR50, and ACR70 criteria; and hybrid ACR', 'pharmacokinetics (PK), safety, and efficacy', 'Safety and immunogenicity profiles', 'Efficacy and safety', 'efficacy, safety, or immunogenicity', 'safety and immunogenicity profiles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0001239', 'cui_str': 'Actin-binding protein'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.0484735,"Safety and immunogenicity profiles of ABP 798 were comparable across treatment groups and not affected by single transition from RP to ABP 798.
","[{'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Burmester', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Free University and Humboldt University Berlin, Charité-University Medicine Berlin, Charitéplatz 1, 10117, Berlin, Germany. gerd.burmester@charite.de.'}, {'ForeName': 'Edit', 'Initials': 'E', 'LastName': 'Drescher', 'Affiliation': 'Veszprém Csolnoky Ferenc County Hospital, Veszprém, Hungary.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Hrycaj', 'Affiliation': 'Rheumatology, Koscian Municipal Hospital, Koscian, Poland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chien', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Metroplex Clinical Research Center, Dallas, TX, USA.'}]",Clinical rheumatology,['10.1007/s10067-020-05305-y']
1522,32872123,A Nursery-Based Cooking Skills Programme with Parents and Children Reduced Food Fussiness and Increased Willingness to Try Vegetables: A Quasi-Experimental Study.,"Children's fussy eating is associated with a reduced vegetable intake. This quasi-experimental study evaluated ""Big Chef Little Chef"" (BCLC), a nursery-based cooking skills programme aimed at reducing food fussiness and increasing willingness to try green vegetables by incorporating repeated exposure and sensory learning. Parent and child (3-5 years) dyads attended BCLC for four/1.5 h weekly sessions. A comparison group was recruited after BCLC completion and attended a single education session at week 1. A questionnaire measured food fussiness at week 1 and week 4. At week 4, all children were offered six green vegetables (raw and cooked) and an average score (1 = did not try; 2 = tried it/ate some; 3 = ate it all) was calculated for willingness to try vegetables. In total, 121 dyads (intervention:  n  = 64; comparison:  n  = 57) participated. The food fussiness score (1 min-5 max) in the intervention group decreased significantly from 3.0 to 2.6 ( p  < 0.01) between time points, while there was no change in the comparison group (3.1 (week 1) and 3.0 (week 4)). The intervention group was more willing to try green vegetables with significantly higher ( p  < 0.001) median scores for raw and cooked vegetables (2.5 for both) compared with the comparison group (2.0 and 1.7, respectively). The BCLC reduced food fussiness and increased willingness to try green vegetables.",2020,"The intervention group was more willing to try green vegetables with significantly higher ( p  < 0.001) median scores for raw and cooked vegetables (2.5 for both) compared with the comparison group (2.0 and 1.7, respectively).","[""Children's fussy eating"", 'In total, 121 dyads (intervention:  n  = 64; comparison:  n  = 57) participated']","['Big Chef Little Chef"" (BCLC']","['Food Fussiness and Increased Willingness to Try Vegetables', 'median scores for raw and cooked vegetables', 'food fussiness score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0554202', 'cui_str': 'Chef'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}]","[{'cui': 'C5197784', 'cui_str': 'Picky Eating'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C3853209', 'cui_str': 'Cooked vegetable'}]",121.0,0.0204112,"The intervention group was more willing to try green vegetables with significantly higher ( p  < 0.001) median scores for raw and cooked vegetables (2.5 for both) compared with the comparison group (2.0 and 1.7, respectively).","[{'ForeName': 'Ada L', 'Initials': 'AL', 'LastName': 'Garcia', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow G31 2ER, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Brown', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow G31 2ER, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Goodale', 'Affiliation': 'Academic Achievement Team, Library Services, Liverpool John Moores University, Liverpool L3 5UX, UK.'}, {'ForeName': 'Mairi', 'Initials': 'M', 'LastName': 'McLachlan', 'Affiliation': 'Lanarkshire Community Food and Health Partnership, Bargeddie G69 7TU, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Parrett', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow G31 2ER, UK.'}]",Nutrients,['10.3390/nu12092623']
1523,32873354,"Beneficial effect on serum cholesterol levels, but not glycaemic regulation, after replacing SFA with PUFA for 3 d: a randomised crossover trial.","Replacing intake of SFA with PUFA reduces serum cholesterol levels and CVD risk. The effect on glycaemic regulation is, however, less clear. The main objective of the present study was to investigate the short-term effect of replacing dietary SFA with PUFA on glycaemic regulation. Seventeen healthy, normal-weight participants completed a 25-d double-blind, randomised and controlled two-period crossover study. Participants were allocated to either interventions with PUFA products or SFA products (control) in a random order for three consecutive days, separated by a 1·5-week washout period between the intervention periods. Glucose, insulin and TAG were measured before and after an oral glucose tolerance test. In addition, fasting total cholesterol, NEFA and plasma total fatty acid profile were measured before and after the 3-d interventions. Fasting and postprandial glucose, insulin, and TAG levels and fasting levels of NEFA and plasma fatty acid profile did not differ between the groups. However, replacing dietary SFA with PUFA significantly reduced total cholesterol levels by 8 % after 3 d (P = 0·002). Replacing dietary SFA with PUFA for only 3 d has beneficial cardio-metabolic effects by reducing cholesterol levels in healthy individuals.",2020,"However, replacing dietary SFA with PUFA significantly reduced total cholesterol levels with 8 % after three days (P = 0.002).","['Seventeen healthy, normal-weight participants', 'healthy individuals']","['interventions with PUFA products or SFA products (control', 'saturated fatty acids (SFA) with polyunsaturated fatty acids (PUFA']","['Fasting and postprandial glucose, insulin, and triglyceride levels and fasting levels of non-esterified fatty acids and plasma fatty acids profile', 'Glucose, insulin and triglycerides', 'serum cholesterol levels', 'cholesterol levels', 'fasting total cholesterol, non-esterified fatty acids and plasma total fatty acid profile', 'total cholesterol levels', 'serum cholesterol levels and cardiovascular disease risk']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.12481,"However, replacing dietary SFA with PUFA significantly reduced total cholesterol levels with 8 % after three days (P = 0.002).","[{'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Gaundal', 'Affiliation': 'Faculty of Health Sciences, Oslo Metropolitan University, 0130Oslo, Norway.'}, {'ForeName': 'Mari C W', 'Initials': 'MCW', 'LastName': 'Myhrstad', 'Affiliation': 'Faculty of Health Sciences, Oslo Metropolitan University, 0130Oslo, Norway.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Leder', 'Affiliation': 'Mills AS, 0558Oslo, Norway.'}, {'ForeName': 'Marte Gjeitung', 'Initials': 'MG', 'LastName': 'Byfuglien', 'Affiliation': 'Mills AS, 0558Oslo, Norway.'}, {'ForeName': 'Terje', 'Initials': 'T', 'LastName': 'Gjøvaag', 'Affiliation': 'Faculty of Health Sciences, Oslo Metropolitan University, 0130Oslo, Norway.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Rud', 'Affiliation': 'Nofima (Norwegian Institute of Food, Fisheries and Aquaculture Research), 1433Ås, Norway.'}, {'ForeName': 'Kjetil', 'Initials': 'K', 'LastName': 'Retterstøl', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, 0317Oslo, Norway.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Holven', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, 0317Oslo, Norway.'}, {'ForeName': 'Stine M', 'Initials': 'SM', 'LastName': 'Ulven', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, 0317Oslo, Norway.'}, {'ForeName': 'Vibeke H', 'Initials': 'VH', 'LastName': 'Telle-Hansen', 'Affiliation': 'Faculty of Health Sciences, Oslo Metropolitan University, 0130Oslo, Norway.'}]",The British journal of nutrition,['10.1017/S0007114520003402']
1524,32876010,"Primary Prophylaxis to Prevent Tuberculosis Infection in Prison Inmates: A Randomized, Double-Blind, Placebo-Controlled Trial.","In many low- and middle-income countries, tuberculosis (TB) incidence in prisons is high, exposing incarcerated populations to an elevated risk of TB infection. We conducted a randomized, double-blind, placebo-controlled trial among HIV-negative male inmates of a high TB burden prison to determine whether isoniazid given twice weekly (900 mg) for 12 months prevents TB infection. The primary outcome was QuantiFERON-TB Gold in Plus (QFT) conversion to ≥ 0.35 international units per milliliter (IU/mL) at 6 months; secondary outcomes included alternative QFT thresholds (≥ 0.7, ≥ 2.0, and ≥ 4.0 IU/mL). In total, 467 participants were randomly assigned to intervention ( N  = 258) or control ( N  = 209). In an interim analysis of participants who had completed 6 months of follow-up ( N  = 170), QFT conversion occurred in 20.8% (19/91) and 21.5% (17/79) of participants in intervention and control arms (efficacy: 2.9%,  P  = 0.91), respectively. The trial was then stopped according to the trial protocol, and the remaining participants prematurely discontinued. In an analysis of secondary outcomes, the intervention arm had significantly lower rates of conversion at a cutoff of ≥ 2.0 IU/mL (efficacy: 82.6%,  P  < 0.01). In conclusion, 900 mg of isoniazid, administered twice a week, did not effectively prevent QFT conversion at a cutoff point ≥ 0.35 IU/mL in a trial of QFT-negative inmates. Higher QFT cutoffs are associated with sustained conversion and greater protection. Future clinical trials that evaluate protection for latent infection should use the highest cutoff than that recommended by the manufacturer.",2020,"In an analysis of secondary outcomes, the intervention arm had significantly lower rates of conversion at a cutoff of ≥ 2.0 IU/mL (efficacy: 82.6%,  P  < 0.01).","['Prison Inmates', '467 participants were randomly assigned to intervention ( N  = 258) or control ( N  = 209', 'HIV-negative male inmates of a high TB burden prison']","['placebo', 'Placebo', 'isoniazid']","['QFT conversion', 'QuantiFERON-TB Gold in Plus (QFT) conversion to ≥ 0.35 international units per milliliter (IU/mL', 'alternative QFT thresholds', 'TB infection', 'rates of conversion']","[{'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C4517784', 'cui_str': '467'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}]","[{'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C0439458', 'cui_str': 'IU/mL'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",467.0,0.713576,"In an analysis of secondary outcomes, the intervention arm had significantly lower rates of conversion at a cutoff of ≥ 2.0 IU/mL (efficacy: 82.6%,  P  < 0.01).","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Dias de Oliveira', 'Affiliation': 'Federal University of Mato Grosso do Sul, Campo Grande, Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'da Silva Santos', 'Affiliation': 'Federal University of Grande Dourados, Dourados, Brazil.'}, {'ForeName': 'Cassia Barbosa', 'Initials': 'CB', 'LastName': 'Reis', 'Affiliation': 'Federal University of Mato Grosso do Sul, Campo Grande, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'de Cássia Leite', 'Affiliation': 'Federal University of Mato Grosso do Sul, Campo Grande, Brazil.'}, {'ForeName': 'Flávia Patussi', 'Initials': 'FP', 'LastName': 'Correia Sacchi', 'Affiliation': 'Municipal Health Office, Dourados, Brazil.'}, {'ForeName': 'Rafaele Carla Pivetta', 'Initials': 'RCP', 'LastName': 'de Araujo', 'Affiliation': 'Federal University of Grande Dourados, Dourados, Brazil.'}, {'ForeName': 'Paulo César Pereira', 'Initials': 'PCP', 'LastName': 'Dos Santos', 'Affiliation': 'Federal University of Grande Dourados, Dourados, Brazil.'}, {'ForeName': 'Valeria Cavalcanti', 'Initials': 'VC', 'LastName': 'Rolla', 'Affiliation': 'Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Martinez', 'Affiliation': 'Stanford University, Stanford, California.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Andrews', 'Affiliation': 'Stanford University, Stanford, California.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Croda', 'Affiliation': 'Federal University of Mato Grosso do Sul, Campo Grande, Brazil.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0110']
1525,32871336,Single dose testosterone administration modulates the temporal dynamics of distractor processing.,"Some evidence suggests that testosterone can increase attentional orientation toward biologically relevant stimuli and increase sustained attention during goal-oriented behaviors. While rare irregular distractors often capture attention involuntarily and distract us away from the task at hand, we hypothesized that testosterone might (1) facilitate attentional orientation to novel distractors that are of potential behavioral relevance and (2) inhibit information processing of distractors that are irrelevant to the task. To test this hypothesis, we investigated the effects of testosterone on distractor processing in a novelty oddball task, during which infrequent target and distractor sounds were interspersed within a series of frequent non-target sounds. Using a double-blind, placebo-controlled within-participant design, we administered a single dose of either testosterone or placebo to 34 healthy male volunteers and compared their electroencephalographic responses to distractors. Increased amplitude of the early (260-310 ms) P3 component-which has been associated with phasic arousal and alertness triggered by novel stimuli-was observed in the testosterone session than in the placebo session. This early-P3 response mediated the effect of testosterone administration on target hit rate during the task. In addition, less α-oscillation suppression-which has been associated with the inhibition of task-irrelevant information processing-was observed in response to distractors later (538-757 ms) in the testosterone session than in the placebo session. These results suggest that testosterone facilitated phasic arousal to novel distractors during the early-latency stage, which might have influenced behavioral performance during the task. Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task. Our findings highlight the role of testosterone in distractor processing, and provide a theoretical basis for treating attention-related behavioral disorders with hormone therapies.",2020,"Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task.",['34 healthy male volunteers'],"['placebo', 'testosterone', 'testosterone or placebo']",['temporal dynamics of distractor processing'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",34.0,0.311301,"Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task.","[{'ForeName': 'Huihua', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, Guangdong, China; Department of Psychology, University of Mannheim, Mannheim, Germany.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, Guangdong, China. Electronic address: ww.peng0923@gmail.com.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104838']
1526,32871397,Neuromuscular training improves knee proprioception in athletes with a history of anterior cruciate ligament reconstruction: A randomized controlled trial.,"BACKGROUND


Athletes exhibit deficits in knee proprioception following anterior cruciate ligament reconstruction. Neuromuscular training programs improve knee proprioception in uninjured athletes; however, the effects on knee proprioception in athletes who have undergone anterior cruciate ligament reconstruction is not well understood. The purpose of this study was to examine the effects of a neuromuscular training program on knee proprioception in athletes who have returned to sport following anterior cruciate ligament reconstruction.
METHODS


Twenty-four male athletes, who had undergone anterior cruciate ligament reconstruction within the previous 6-12 months and returned to sport, participated in this randomized controlled trial. Athletes were randomly allocated to an experimental group (n = 12) that took part in an 8-week neuromuscular training program or a control group (n = 12) that simply continued their typical training routine. Knee position sense was assessed at baseline and after the 8-week period (post-testing). One-way analysis of covariance, with baseline performance included as a covariate, was used to compare knee position sense errors for the reconstructed limbs of the experimental and control groups at the post-testing time point.
FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period. As a result, the experimental group demonstrated lower knee position sense errors, compared to the control group, at the post-testing time point (P < .001).
INTERPRETATION


Athletes with a history of anterior cruciate ligament reconstruction may benefit from participation in a neuromuscular training program, even after completing post-operative rehabilitation.",2020,"FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period.","['athletes who have undergone anterior cruciate ligament reconstruction', 'Twenty-four male athletes, who had undergone anterior cruciate ligament reconstruction within the previous 6-12\xa0months and returned to sport', 'anterior cruciate ligament reconstruction', 'athletes who have returned to sport following anterior cruciate ligament reconstruction', 'athletes with a history of anterior cruciate ligament reconstruction', 'Athletes with a history of anterior cruciate ligament reconstruction', 'uninjured athletes']","['Neuromuscular training', 'neuromuscular training program', 'Neuromuscular training programs', 'neuromuscular training program or a control group (n\xa0=\xa012) that simply continued their typical training routine']","['lower knee position sense errors', 'knee proprioception', 'Knee position sense errors', 'Knee position sense']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}]",24.0,0.0152322,"FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period.","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ghaderi', 'Affiliation': 'Kharazmi University, No. 43, South Mofatteh Ave., Tehran 15719-14911, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Kharazmi University, No. 43, South Mofatteh Ave., Tehran 15719-14911, Iran.'}, {'ForeName': 'Thomas Gus', 'Initials': 'TG', 'LastName': 'Almonroeder', 'Affiliation': 'University of Wisconsin - La Crosse, 1300 Badger St., La Crosse, WI 54601, United States. Electronic address: talmonroeder@uwlax.edu.'}, {'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Keyhani', 'Affiliation': 'Akhtar Hospital, Shahid Beheshti University of Medical Sciences, Velenjak St., Tehran 19857-17443, Iran.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105157']
1527,32877425,Gamification as an approach to improve resilience and reduce attrition in mobile mental health interventions: A randomized controlled trial.,"Forty percent of all general-practitioner appointments are related to mental illness, although less than 35% of individuals have access to therapy and psychological care, indicating a pressing need for accessible and affordable therapy tools. The ubiquity of smartphones offers a delivery platform for such tools. Previous research suggests that gamification-turning intervention content into a game format-could increase engagement with prevention and early-stage mobile interventions. This study aimed to explore the effects of a gamified mobile mental health intervention on improvements in resilience, in comparison with active and inactive control conditions. Differences between conditions on changes in personal growth, anxiety and psychological wellbeing, as well as differences in attrition rates, were also assessed. The eQuoo app was developed and published on all leading mobile platforms. The app educates users about psychological concepts including emotional bids, generalization, and reciprocity through psychoeducation, storytelling, and gamification. In total, 358 participants completed in a 5-week, 3-armed (eQuoo, ""treatment as usual"" cognitive behavioral therapy journal app, no-intervention waitlist) randomized controlled trial. Relevant scales were administered to all participants on days 1, 17, and 35. Repeated-measures ANOVA revealed statistically significant increases in resilience in the test group compared with both control groups over 5 weeks. The app also significantly increased personal growth, positive relations with others, and anxiety. With 90% adherence, eQuoo retained 21% more participants than the control or waitlist groups. Intervention delivered via eQuoo significantly raised mental well-being and decreased self-reported anxiety while enhancing adherence in comparison with the control conditions. Mobile apps using gamification can be a valuable and effective platform for well-being and mental health interventions and may enhance motivation and reduce attrition. Future research should measure eQuoo's effect on anxiety with a more sensitive tool and examine the impact of eQuoo on a clinical population.",2020,Intervention delivered via eQuoo significantly raised mental well-being and decreased self-reported anxiety while enhancing adherence in comparison with the control conditions.,"['mobile mental health interventions', '358 participants completed in a 5-week, 3-armed (eQuoo, ""treatment as usual"" cognitive behavioral therapy journal app, no-intervention waitlist) randomized controlled trial']",['gamified mobile mental health intervention'],"['personal growth, anxiety and psychological wellbeing', 'resilience', 'personal growth, positive relations with others, and anxiety', 'attrition rates']","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",358.0,0.122714,Intervention delivered via eQuoo significantly raised mental well-being and decreased self-reported anxiety while enhancing adherence in comparison with the control conditions.,"[{'ForeName': 'Silja', 'Initials': 'S', 'LastName': 'Litvin', 'Affiliation': 'Department of General Psychology II (Emotion and Motivation), Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Saunders', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, Centre for Outcomes Research and Effectiveness, University College London, London, United Kingdom.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Maier', 'Affiliation': 'Department of General Psychology II (Emotion and Motivation), Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lüttke', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Tübingen, Tübingen, Germany.'}]",PloS one,['10.1371/journal.pone.0237220']
1528,32878045,Drinking Refined Deep-Sea Water Improves the Gut Ecosystem with Beneficial Effects on Intestinal Health in Humans: A Randomized Double-Blind Controlled Trial.,"World health trends are focusing on a balanced food and beverage intake for healthy life. Refined deep-sea water (RDSW), obtained from deep-sea water collected offshore in Muroto (Japan), is mineral-rich drinking water. We previously reported that drinking RDSW improves human gut health. Here, we analyzed the effect of drinking RDSW on the gut ecosystem to understand this effect. This was a randomized double-blind controlled trial. Ninety-eight healthy adults were divided into two groups: RDSW or mineral water (control). The participants consumed 1 L of either water type daily for 12 weeks. A self-administered questionnaire and stool and urine samples were collected through the intervention. The following were determined: fecal biomarkers of secretory immunoglobulin A (sIgA), five putrefactive products, and nine short-chain-fatty-acids (SCFAs) as the primary outcomes; and three urinary isoflavones and the questionnaire as secondary outcomes. In post-intervention in the RDSW group, we found increased concentrations of five SCFAs and decreased concentrations of phenol and sIgA ( p  < 0.05). The multiple logistic analysis demonstrated that RDSW significantly affected two biomarkers (acetic and 3-methylbutanoic acids) of the five SCFAs mentioned above ( p  < 0.05). Similarly, the concentrations of urinary isoflavones tended to increase in post-intervention in the RDSW group. Constipation was significantly alleviated in the RDSW group (94%) compared with the control group (60%). Drinking RDSW improves the intestinal environment, increasing fecal SCFAs and urinary isoflavones, which leads to broad beneficial effects in human.",2020,Constipation was significantly alleviated in the RDSW group (94%) compared with the control group (60%).,"['Humans', 'Ninety-eight healthy adults']","['RDSW or mineral water (control', 'drinking RDSW']","['fecal biomarkers of secretory immunoglobulin A (sIgA), five putrefactive products, and nine short-chain-fatty-acids (SCFAs', 'concentrations of urinary isoflavones', 'Constipation', 'concentrations of five SCFAs and decreased concentrations of phenol and sIgA', 'biomarkers (acetic and 3-methylbutanoic acids']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0719712', 'cui_str': 'Deep Sea'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0026157', 'cui_str': 'Mineral water'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0020838', 'cui_str': 'Immunoglobulin A secretory'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0031428', 'cui_str': 'Phenols'}, {'cui': 'C0064094', 'cui_str': 'Isovaleric acid'}]",98.0,0.139382,Constipation was significantly alleviated in the RDSW group (94%) compared with the control group (60%).,"[{'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Medical Laboratory Sciences, Health and Sciences, International University of Health and Welfare Graduate School, 4-3 Kouzunomori, Narita-City 286-8686, Chiba, Japan.'}, {'ForeName': 'Keiro', 'Initials': 'K', 'LastName': 'Higuchi', 'Affiliation': 'Center for Regional Collaboration, Kochi University, 2-17-47 Asakurahonmachi, Kochi-City 780-8073, Kochi, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yoshikane', 'Affiliation': 'Department of Human Living Sciences, Notre Dame Seishin University, 2-16-9 Ifuku-cho, Kita-ku, Okayama-City 700-8516, Okayama, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Takagi', 'Affiliation': 'Department of Kochi Medical School, Kochi University, Kohasu, Oko-cho, Nankoku-City 783-8505, Kochi, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Tokuhiro', 'Affiliation': 'Department of Kochi Medical School, Kochi University, Kohasu, Oko-cho, Nankoku-City 783-8505, Kochi, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Takenaka', 'Affiliation': 'DyDo-T Beverage Co. Ltd., 1310-1 Hanechou-ko, Muroto-City 781-6741, Kochi, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Oboshi', 'Affiliation': 'Department of Medical Laboratory Sciences, Health and Sciences, International University of Health and Welfare Graduate School, 4-3 Kouzunomori, Narita-City 286-8686, Chiba, Japan.'}, {'ForeName': 'Asako', 'Initials': 'A', 'LastName': 'Kimura', 'Affiliation': 'Department of Medical Laboratory Sciences, Health and Sciences, International University of Health and Welfare Graduate School, 4-3 Kouzunomori, Narita-City 286-8686, Chiba, Japan.'}, {'ForeName': 'Jahirul Md', 'Initials': 'JM', 'LastName': 'Islam', 'Affiliation': 'Department of Medical Laboratory Sciences, Health and Sciences, International University of Health and Welfare Graduate School, 4-3 Kouzunomori, Narita-City 286-8686, Chiba, Japan.'}, {'ForeName': 'Ayami', 'Initials': 'A', 'LastName': 'Kaneko', 'Affiliation': 'Department of Medical Laboratory Sciences, Health and Sciences, International University of Health and Welfare Graduate School, 4-3 Kouzunomori, Narita-City 286-8686, Chiba, Japan.'}, {'ForeName': 'Shouichi', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Department of Medical Laboratory Sciences, Health and Sciences, International University of Health and Welfare Graduate School, 4-3 Kouzunomori, Narita-City 286-8686, Chiba, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Ishizuka', 'Affiliation': 'Center for Regional Collaboration, Kochi University, 2-17-47 Asakurahonmachi, Kochi-City 780-8073, Kochi, Japan.'}]",Nutrients,['10.3390/nu12092646']
1529,32881712,Stretch-induced hypoalgesia: a pilot study.,"Objectives Stretching is an intervention often used in various kinds of rehabilitation protocols and the effects on pain sensitivity has sparsely been investigated, especially when addressing potential effects on pain. The objective is to investigate the immediate effects of an axial and peripheral prolonged stretch on pressure pain sensitivity (PPT) and temporal summation (TS) on local and distal sites in healthy subjects. Methods Twenty-two healthy volunteers were recruited to participate in this pilot study. Two prolonged stretching protocols were performed: low back and wrist extensors stretches. PPT and pinprick TS were measured pre- and post-intervention at local and remote sites. Repeated measures analysis of variance (ANOVA) was used to examine the effects and significance of the interventions. Results The low back stretch induced an increase in PPT for both local and remote sites, and the wrist stretch produced a PPT increase only at the local site. TS did not change. Conclusions Low back stretching induced an increase in PPT at both local and remote sites whereas the wrist stretch only increased PPT locally, suggesting hypoalgesia at these sites. Further studies are needed to confirm the effect and mechanisms using randomised, controlled and parallel study design. Considering that pain sensitivity is different than clinical pain, results are difficult to extrapolate to clinical practice. Future studies testing clinical pain are needed to better understand the clinical implication of these results.",2020,"The low back stretch induced an increase in PPT for both local and remote sites, and the wrist stretch produced a PPT increase only at the local site.","['Methods Twenty-two healthy volunteers', 'healthy subjects']","['axial and peripheral prolonged stretch', 'Stretch-induced hypoalgesia']","['PPT and pinprick TS', 'pressure pain sensitivity (PPT) and temporal summation (TS']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0085625', 'cui_str': 'Hypoalgesia'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}]",22.0,0.0337781,"The low back stretch induced an increase in PPT for both local and remote sites, and the wrist stretch produced a PPT increase only at the local site.","[{'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Larouche', 'Affiliation': 'McGill University, School of Occupational and Physical Therapy, Montreal, Canada.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Camiré Bernier', 'Affiliation': 'McGill University, School of Occupational and Physical Therapy, Montreal, Canada.'}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Racine', 'Affiliation': 'McGill University, School of Occupational and Physical Therapy, Montreal, Canada.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Collin', 'Affiliation': 'McGill University, School of Occupational and Physical Therapy, Montreal, Canada.'}, {'ForeName': 'Mikaël', 'Initials': 'M', 'LastName': 'Desmons', 'Affiliation': 'Cirris research centre, Université Laval, Quebec City, Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mailloux', 'Affiliation': 'Cirris research centre, Université Laval, Quebec City, Canada.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Massé-Alarie', 'Affiliation': 'Cirris research centre, Université Laval, Quebec City, Canada.'}]",Scandinavian journal of pain,['10.1515/sjpain-2020-0018']
1530,32882399,Long QT syndrome type 1 and 2 patients respond differently to arrhythmic triggers: The TriQarr in vivo study.,"BACKGROUND


In patients with long QT syndrome (LQTS), swimming and loud noises have been identified as genotype-specific arrhythmic triggers in LQTS type 1 (LQTS1) and LQTS type 2 (LQTS2), respectively.
OBJECTIVE


The purpose of this study was to compare LQTS group responses to arrhythmic triggers.
METHODS


LQTS1 and LQTS2 patients were included. Before and after beta-blocker intake, electrocardiograms were recorded as participants (1) were exposed to a loud noise of ∼100 dB; and (2) had their face immersed into cold water.
RESULTS


Twenty-three patients (9 LQTS1, 14 LQTS2) participated. In response to noise, LQTS groups showed similarly increased heart rate, but LQTS2 patients had corrected QT interval (Fridericia formula) (QTcF) prolonged significantly more than LQTS1 patients (37 ± 8 ms vs 15 ± 6 ms; P = .02). After intake of beta-blocker, QTcF prolongation in LQTS2 patients was significantly blunted and similar to that of LQTS1 patients (P = .90). In response to simulated diving, LQTS groups experienced a heart rate drop of ∼28 bpm, which shortened QTcF similarly in both groups. After intake of beta-blockers, heart rate dropped to 28 ± 2 bpm in LQTS1 patients and 20 ± 3 bpm in LQTS2, resulting in a slower heart rate in LQTS1 compared with LQTS2 (P = .01). In response, QTcF shortened similarly in LQTS1 and LQTS2 patients (57 ± 9 ms vs 36 ± 7 ms; P = .10).
CONCLUSION


When exposed to noise, LQTS2 patients had QTc prolonged significantly more than did LQTS1 patients. Importantly, beta-blockers reduced noise-induced QTc prolongation in LQTS2 patients, thus demonstrating the protective effect of beta-blockers. In response to simulated diving, LQTS groups responded similarly, but a slower heart rate was observed in LQTS1 patients during simulated diving after beta-blocker intake.",2020,"In response to simulated diving, LQTS groups responded similarly, but a slower heart rate was observed in LQTS1 patients during simulated diving after beta blockers.",['patients with long QT syndrome (LQTS'],"['LQTS1', 'TriQarr', 'LQTS']","['noise-induced QTc prolongation', 'QTcF prolongation', 'heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023976', 'cui_str': 'Long QT syndrome'}]","[{'cui': 'C0023976', 'cui_str': 'Long QT syndrome'}]","[{'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0855333', 'cui_str': 'Electrocardiogram QT corrected interval prolonged'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",23.0,0.018453,"In response to simulated diving, LQTS groups responded similarly, but a slower heart rate was observed in LQTS1 patients during simulated diving after beta blockers.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Marstrand', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University Hospital of Copenhagen, Herlev, Denmark. Electronic address: pmarstrand@hotmail.com.'}, {'ForeName': 'Kasim', 'Initials': 'K', 'LastName': 'Almatlouh', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University Hospital of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Jørgen K', 'Initials': 'JK', 'LastName': 'Kanters', 'Affiliation': 'Laboratory of Experimental Cardiology, Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Graff', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Alex Hørby', 'Initials': 'AH', 'LastName': 'Christensen', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University Hospital of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Bundgaard', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Theilade', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University Hospital of Copenhagen, Herlev, Denmark.'}]",Heart rhythm,['10.1016/j.hrthm.2020.08.017']
1531,32882429,"A randomized, sham-controlled trial of intraductal meibomian gland probing with or without topical antibiotic/steroid for obstructive meibomian gland dysfunction.","IMPORTANCE


Obstructive meibomian gland dysfunction (MGD) can be refractory to medical therapy. Intraductal meibomian gland (MG) probing may offer a potential therapeutic approach for these patients, but no randomized trials have been conducted to date.
OBJECTIVE


To assess clinical changes after intraductal MG probing for patients with refractory obstructive meibomian gland dysfunction.
DESIGN


Randomized, double-masked, sham-controlled clinical trial.
SETTING


Single-center, tertiary referral center.
PARTICIPANTS


42 patients with refractory obstructive MGD associated with lid tenderness.
INTERVENTIONS


Enrolled patients received one of the following treatments: 1) MG probing plus post-procedural topical sulfacetamide/prednisolone ointment (Blephamide®), 2) MG probing plus post-procedural lubricating ointment (GenTeal), or 3) sham probing plus GenTeal ointment. The probing was performed on the upper lids of both eyes.
MAIN OUTCOME MEASURES


Primary outcome measures were symptoms as measured by Ocular Surface Disease Index (OSDI) and Symptom Assessment iN Dry Eye (SANDE), as well as tear break-up time (TBUT). Secondary outcome measures were other clinical signs. Safety of the procedure was also evaluated by investigating the treatment-related adverse events. At baseline and 4 weeks after the procedure a masked observer evaluated the following outcome measures: symptom questionnaires, including OSDI and SANDE, upper lid tenderness, lid margin telangiectasia, corneal fluorescein staining, conjunctival lissamine green staining, TBUT, Schirmer's test, and meibomian glands yielding liquid secretion (MGYLS).
RESULTS


Compared to baseline, the MG probing/Blephamide® group showed significant improvements in both OSDI and SANDE scores and the MG probing/GenTeal group demonstrated a significant improvement only in SANDE score. In contrast, the Sham/GenTeal group did not show any statistically significant changes in symptoms. There were no statistically significant changes in clinical signs in any group at the 4-week visit, except for improvement of lid tenderness in the sham probing group.
CONCLUSIONS


MG probing/Blephamide® results in a significant improvement in symptoms in patients with refractory obstructive MGD without any significant effect on clinical signs. Larger studies are warranted to determine the efficacy of MG probing.
TRIAL REGISTRATION


Clinicaltrials.gov(identifier NCT02256969, Filed on 08/13/2014).",2020,"There were no statistically significant changes in clinical signs in any group at 4-week visit except for improvement of lid tenderness in the sham probing group.
","['patients with refractory obstructive meibomian gland dysfunction', 'patients with refractory obstructive MGD', 'obstructive meibomian gland dysfunction', '42 patients with refractory obstructive MGD associated with lid tenderness', 'Single-center, tertiary referral center']","['intraductal meibomian gland probing with or without topical antibiotic/steroid', 'MG probing plus post-procedural topical sulfacetamide/prednisolone ointment (Blephamide®), 2) MG probing plus post-procedural lubricating ointment (GenTeal), or 3) sham probing plus GenTeal ointment']","[""outcome measures: symptom questionnaires, including OSDI and SANDE, upper lid tenderness, lid margin telangiectasia, corneal fluorescein staining, conjunctival lissamine green staining, TBUT, Schirmer's test, and meibomian glands yielding liquid secretion (MGYLS"", 'SANDE score', 'symptoms', 'lid tenderness', 'OSDI and SANDE scores', 'clinical signs', 'symptoms as measured by Ocular Surface Disease Index (OSDI) and Symptom Assessment iN Dry Eye (SANDE), as well as tear break-up time (TBUT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C1512936', 'cui_str': 'Intraductal route'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038670', 'cui_str': 'Sulfacetamide'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0718966', 'cui_str': 'Blephamide'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0720651', 'cui_str': 'GenTeal'}]","[{'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0444582', 'cui_str': 'Structure of free margin of eyelid'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",42.0,0.276796,"There were no statistically significant changes in clinical signs in any group at 4-week visit except for improvement of lid tenderness in the sham probing group.
","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Kheirkhah', 'Affiliation': 'Massachusetts Eye and Ear Infirmary, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA; Department of Ophthalmology, Long School of Medicine, University of Texas Health at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Hidenaga', 'Initials': 'H', 'LastName': 'Kobashi', 'Affiliation': 'Massachusetts Eye and Ear Infirmary, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Girgis', 'Affiliation': 'Massachusetts Eye and Ear Infirmary, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Arsia', 'Initials': 'A', 'LastName': 'Jamali', 'Affiliation': 'Center for Translational Ocular Immunology, USA.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Ciolino', 'Affiliation': 'Massachusetts Eye and Ear Infirmary, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA. Electronic address: Joseph_Ciolino@meei.harvard.edu.'}, {'ForeName': 'Pedram', 'Initials': 'P', 'LastName': 'Hamrah', 'Affiliation': 'Massachusetts Eye and Ear Infirmary, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA; Center for Translational Ocular Immunology, USA; Cornea Service, New England Eye Center, And Department of Ophthalmology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA. Electronic address: pedram.hamrah@tufts.edu.'}]",The ocular surface,['10.1016/j.jtos.2020.08.008']
1532,32888343,The impact of survey mode on US national estimates of adolescent drug prevalence: results from a randomized controlled study.,"BACKGROUND AND AIMS


Increasing numbers of school-based drug surveys are transitioning data collection to electronic tablets from paper-and-pencil, which may produce a survey mode effect and consequent discontinuity in time trends for population estimates of drug prevalence. This study tested whether (a) overall, self-reported drug use prevalence is higher on electronic tablets versus paper-and-pencil surveys, (b) socio-demographics moderate survey mode effects and (c) levels of missing data are lower for electronic tablet versus paper-and-pencil modes.
DESIGN


A randomized controlled experiment.
SETTING


Results are nationally representative of students in the contiguous United States.
PARTICIPANTS


A total of 41 866 8th, 10th and 12th grade students who participated in the 2019 Monitoring the Future school-based survey administration.
INTERVENTION AND COMPARATOR


Surveys were administered to students in a randomly selected half of schools with electronic tablets (intervention) and with paper-and-pencil format (comparator) for the other half.
MEASUREMENTS


Primary outcome was the total number of positive drug use responses. Secondary outcomes were the percentage of respondents completing all drug questions, percentage of drug questions unanswered and mean number of missing drug items.
FINDINGS


The relative risk (RR) for total number of positive drug use responses for electronic tablets versus paper-and-pencil surveys were small and their 95% confidence intervals (CI) included the value of one for reporting intervals of life-time (RR = 1.03; 95% CI, 0.93-1.14), past 12 months (RR = 1.01; 95% CI, 0.91-1.11), past 30 days (RR = 1.05; 95% CI, 0.93-1.20) and for heavy use (RR = 1.10; 95% CI, 0.93-1.29). Multiplicative interaction tests indicated no moderation of these relative risks by race (white versus non-white), population density, census region, public/private school, year of school participation, survey version or non-complete drug responses. Levels of missing data were significantly lower for electronic tablets versus paper-and-pencil surveys.
CONCLUSIONS


Adolescent drug prevalence estimates in the United States differed little across electronic tablet versus paper-and-pencil survey modes, and showed little to no effect modification by socio-demographics. Levels of missing data were lower for electronic tablets.",2020,"Multiplicative interaction tests indicated no moderation of these relative risks by race (white v. nonwhite), population density, census region, public/private school, year of school participation, survey version, or non-complete drug responses.","['41,866 8th, 10th, and 12th grade students who participated in the 2019 Monitoring the Future school-based survey administration', 'Results are nationally-representative of students in the contiguous United States', 'Adolescent Drug Prevalence']",['electronic tablets (intervention) and with paper-and-pencil format (comparator) for the other half'],"['total number of positive drug use responses', 'percent of respondents completing all drug questions, percent of drug questions unanswered, and mean number of missing drug items', 'Levels of missing data']","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205283', 'cui_str': 'Contiguous'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0441059', 'cui_str': 'Pencil'}, {'cui': 'C1301627', 'cui_str': 'Format'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",41866.0,0.149561,"Multiplicative interaction tests indicated no moderation of these relative risks by race (white v. nonwhite), population density, census region, public/private school, year of school participation, survey version, or non-complete drug responses.","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Miech', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Mick P', 'Initials': 'MP', 'LastName': 'Couper', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Heeringa', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patrick', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15249']
1533,32889172,Validation of local p16 testing for determination of human papilloma virus status eligibility on a low risk oropharyngeal cancer trial - A Trans-Tasman Radiation Oncology Group study.,"OBJECTIVE


Accurate determination of human papilloma virus (HPV) status is critical when identifying patients with oropharyngeal squamous cell carcinoma (OPSCC) who may be candidates for de-escalation trials. In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
METHODS AND MATERIALS


Patients enrolled on the TROG 12.01 randomised trial for good prognosis HPVOPSCC were randomised based on local p16 IHC testing but subsequently had central p16 IHC and HPV RNA in situ hybridisation (HPV RNA ISH) testing. Correlations between the local and central p16 and central HPV RNA ISH were studied. The main outcome was the positive predictive value (PPV) of local pathology laboratory testing of p16.
RESULTS


176/182 patients had samples available for central testing. 172/176 were evaluable for central testing of p16, and all were confirmed to be p16 positive (172/172, 100%, 95% CI = [97.9%, 100%]). Similarly, 100% of those evaluable for HPV RNA ISH (155/155, 100%, 95% CI = [97.6%, 100%]) were confirmed HPV positive, indicating p16 overexpression driven by transcriptionally active HPV and a PPV of 100% for local p16 testing.
CONCLUSIONS


Our results validate the suitability of local pathology laboratory p16 testing alone, in populations with a high attributable fraction of OPSCC due to HPV, to screen and enrol low risk HPVOPSCC patients onto de-intensification trials. This obviates the need for upfront more complex and expensive HPV assays and/or central laboratory testing.",2020,"In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
","['populations with a high attributable fraction of OPSCC due to HPV, to screen and enrol low risk HPVOPSCC patients onto de-intensification trials', 'patients with oropharyngeal squamous cell carcinoma (OPSCC', 'Patients enrolled on the TROG 12.01 randomised trial for good prognosis HPVOPSCC', '176/182 patients had samples available for central testing']",['local p16 IHC testing but subsequently had central p16 IHC and HPV RNA in situ hybridisation (HPV RNA ISH) testing'],"['positive predictive value (PPV) of local pathology laboratory testing of p16', 'local and central p16 and central HPV RNA ISH', 'HPV RNA ISH']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0280313', 'cui_str': 'Squamous cell carcinoma of oropharynx'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C0020202', 'cui_str': 'Hybridization'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",,0.269323,"In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Young', 'Affiliation': 'Research Division, Peter MacCallum Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Solomon', 'Affiliation': 'Research Division, Peter MacCallum Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Corry', 'Affiliation': ""Genesiscare St Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Angel', 'Affiliation': 'Department of Pathology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Kenny', 'Affiliation': ""Department of Radiation Oncology, Royal Brisbane & Women's Hospital, Brisbane, Australia; Faculty of Medicine, University of Queensland Brisbane, Australia.""}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Porceddu', 'Affiliation': 'Faculty of Medicine, University of Queensland Brisbane, Australia; Department of Radiation Oncology, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wratten', 'Affiliation': 'Department of Radiation Oncology, Calvary Mater Hospital and University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Macann', 'Affiliation': 'Department of Radiation Oncology, Auckland City Hospital and University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Jackson', 'Affiliation': 'Radiation Oncology Centres, Gold Coast, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Herschtal', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Rischin', 'Affiliation': 'Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia. Electronic address: danny.rischin@petermac.org.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104988']
1534,32889324,Predict overall survival of spinal conventional chordoma: Development and assessment of a new predictive nomogram.,"OBJECTIVE


To predict the 5-year overall survival (OS) rate in patients with conventional chordoma of the spine PATIENTS AND METHODS: The Surveillance, Epidemiology, and End Results (SEER) Registry was used to identify patients with conventional chordoma of the spine from 1994 to 2013. The entire cohort(n = 294) was randomly divided into training (n = 147) and validation (n = 147) cohorts to construct a nomogram. We used the univariate Log-rank test and multivariate Cox model to examine the independent prognostic factors associated with OS. These prognostic factors were integrated to construct a nomogram through R studio. The predictive and validating capacity of the nomogram was calculated by Harrell's concordance index (C-index) and calibration curves.
RESULTS


A total of 294 patients were identified with conventional chordoma of the spine. The patients' age at diagnosis, tumor size, EOD (extent of disease), and treatment were independent prognostic factors and associated with OS. These prognostic factors were incorporated to construct a nomogram. The concordance index for the nomogram was 0.771 and 0.732 in the training cohort and validation cohort, respectively. Internal and external calibration curves for 5-year OS showed excellent matching between nomogram prediction and observed outcomes.
CONCLUSIONS


The findings of this study provide population-based estimates of patients with conventional chordoma of the spine. Using this nomogram, surgeons can classify patients into different risk groups and achieve individualized treatment.",2020,"The concordance index for the nomogram was 0.771 and 0.732 in the training cohort and validation cohort, respectively.","['patients with conventional chordoma of the spine', 'patients with conventional chordoma of the spine from 1994 to 2013', '294 patients were identified with conventional chordoma of the spine']",[],"['Surveillance, Epidemiology, and End Results (SEER', '5-year overall survival (OS) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0008487', 'cui_str': 'Chordoma'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]",[],"[{'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",294.0,0.0249893,"The concordance index for the nomogram was 0.771 and 0.732 in the training cohort and validation cohort, respectively.","[{'ForeName': 'Kaiyuan', 'Initials': 'K', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopedic Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China; Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Kehan', 'Initials': 'K', 'LastName': 'Song', 'Affiliation': 'Department of Orthopedics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shengxing', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Libo', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Huiren', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: wang.huiren@zs-hospital.sh.cn.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: dong.jian@zs-hospital.sh.cn.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106174']
1535,32890575,"A 300 IR sublingual tablet is an effective, safe treatment for house dust mite-induced allergic rhinitis: An international, double-blind, placebo-controlled, randomized phase III clinical trial.","BACKGROUND


Allergic rhinitis induced by house dust mites (HDMs) is a highly prevalent but often underdiagnosed and undertreated/untreated chronic disease. It often has a negative impact on sleep, work, leisure activities, and health-related quality of life. Allergen immunotherapy is a proven, safe treatment for respiratory allergies.
OBJECTIVE


We sought to assess the efficacy and safety of a 300 index of reactivity (IR) sublingual tablet formulation of Dermatophagoides pteronyssinus:Dermatophagoides farinae 1:1 extract in adolescents (aged ≥12) and adults with moderate to severe HDM-induced allergic rhinitis.
METHODS


In a phase III, international, double-blind, placebo-controlled, randomized clinical trial, participants received approximately 12 months of treatment with placebo or the 300 IR tablet. The primary end point was the average total combined score during 4 weeks at the end of the treatment period.
RESULTS


A total of 1607 participants were randomized, and 1476 (including 555 [37.6%] with concomitant mild controlled asthma at inclusion) comprised the full analysis set. Over the primary evaluation period, the least squares mean average total combined score in the 300 IR group (3.62) was significantly lower (P < .0001) than in the placebo group (4.35), with a relative least squares mean difference of -16.9% (95% CI, -24.0% to -9.2%). All prespecified secondary end points were consistently improved in the 300 IR group, relative to placebo. The 300 IR tablet was generally well tolerated. Treatment-related adverse events (mainly mild or moderate local reactions) were reported for 51.0% of the patients in the 300 IR group and 14.9% in the placebo group.
CONCLUSIONS


The 300 IR sublingual HDM tablet is an effective, safe treatment for HDM-induced allergic rhinitis.",2020,"Treatment-related adverse events (mainly mild or moderate local reactions) were reported for 51.0% of the patients in the 300°IR group and 14.9% in the placebo group.
","['adolescents (aged ≥12) and adults with moderate-to-severe HDM-induced AR', '1,607 participants were randomized, and 1,476 (including 555 (37.6%) with concomitant mild controlled asthma at inclusion', 'moderate-to-severe house-dust-mite-induced allergic rhinitis', 'house-dust-mite-induced allergic rhinitis']","['placebo', 'Dermatophagoides pteronyssinus:Dermatophagoides farinae 1:1 extract', 'Dermatophagoides pteronyssinus:Dermatophagoides farinae extract']","['least squares mean aTCS', 'average total combined score (aTCS', 'efficacy and safety', 'adverse events', 'tolerated', 'sleep, work, leisure activities, and health-related quality of life']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517810', 'cui_str': '555'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0323674', 'cui_str': 'Dermatophagoides'}, {'cui': 'C0323677', 'cui_str': 'Dermatophagoides farinae'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1445449', 'cui_str': 'Dermatophagoides farinae diagnostic allergen extract'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0023292', 'cui_str': 'Leisure Activities'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",1607.0,0.257438,"Treatment-related adverse events (mainly mild or moderate local reactions) were reported for 51.0% of the patients in the 300°IR group and 14.9% in the placebo group.
","[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Demoly', 'Affiliation': 'Department of Pulmonology and Addictology, Arnaud de Villeneuve Hospital, Montpellier University, Montpellier, France; Sorbonne Université, UMR-S 1136 INSERM, IPLESP, EPAR Team, Paris, France. Electronic address: pascal.demoly@inserm.fr.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Corren', 'Affiliation': 'Departments of Medicine and Pediatrics, David Geffen School of Medicine at the University of California, Los Angeles, Calif.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Creticos', 'Affiliation': 'Division of Allergy & Clinical Immunology, Johns Hopkins Medicine, Baltimore, Md; Creticos Research Group with Charleston Allergy & Asthma, Charleston, SC.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'De Blay', 'Affiliation': 'Allergy Division, Chest Diseases Department, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gevaert', 'Affiliation': 'Upper Airways Research Laboratory, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hellings', 'Affiliation': 'Department of Otorhinolaryngology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Kowal', 'Affiliation': 'Department of Experimental Allergology and Immunology, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Le Gall', 'Affiliation': 'Global Clinical Development Department, Stallergenes Greer, Antony, France.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Nenasheva', 'Affiliation': 'Russian Medical Academy of Continuous Professional Education of the Ministry of Health of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Passalacqua', 'Affiliation': 'Allergy and Respiratory Diseases, IRCCS Policlinico S. Martino, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Pfaar', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Tortajada-Girbés', 'Affiliation': 'Pediatric Pulmonology and Allergy Unit, Department of Pediatrics, Dr Peset University Hospital, Valencia, Spain; Department of Pediatrics, Obstetrics and Gynecology. University of Valencia, Valencia, Spain; IVI Foundation, Valencia, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Vidal', 'Affiliation': 'Allergy Department, Complejo Hospitalario Universitario de Santiago, Faculty of Medicine, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Margitta', 'Initials': 'M', 'LastName': 'Worm', 'Affiliation': 'Division of Allergy and Immunology, Department of Dermatology, Allergy and Venerology, Charité, Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Casale', 'Affiliation': 'Division of Allergy and Immunology, University of South Florida, Tampa, Fla.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.07.036']
1536,32894967,Effectiveness of Polypill for Prevention of Cardiovascular Disease (PolyPars): Protocol of a Randomized Controlled Trial.,"BACKGROUND


Cardiovascular diseases (CVDs) are the leading cause of death in Iran. A fixed-dose combination therapy (polypill) was proposed as a cost-effective strategy for CVD prevention, especially in lower-resource settings. We conducted the PolyPars trial to assess the effectiveness and safety of polypill for prevention of CVD.
METHODS


The PolyPars trial is a pragmatic cluster randomized controlled trial nested within the Pars Cohort Study. Participants were randomized to an intervention arm and a control arm. Participants in the control arm received minimal non-pharmacological care, while those in the intervention arm received polypill in addition to minimal care. The polypill comprises hydrochlorothiazide 12.5 mg, aspirin 81 mg, atorvastatin 20 mg, and either enalapril 5 mg or valsartan 40 mg. The primary outcome of the study is defined as the first occurrence of acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, sudden cardiac death, new-onset heart failure, coronary artery revascularization procedures, transient ischemic attack, cerebrovascular accidents (fatal or non-fatal), and hospitalization due to any of the mentioned conditions. The secondary outcomes of the study include adverse events, compliance, non-cardiovascular mortality, changes in blood pressure, fasting blood sugar, and lipids after five years of follow-up.
RESULTS


From December 2014 to December 2015, 4415 participants (91 clusters) were recruited. Of those, 2200 were in the polypill arm and 2215 in the minimal care arm. The study is ongoing. This trial was registered with ClinicalTrials.gov number NCT03459560.
CONCLUSION


Polypill may be effective for primary prevention of CVDs in developing countries.",2020,"The secondary outcomes of the study include adverse events, compliance, non-cardiovascular mortality, changes in blood pressure, fasting blood sugar, and lipids after five years of follow-up.
","['4415 participants (91 clusters) were recruited', 'From December 2014 to December 2015']","['enalapril 5 mg or valsartan', 'hydrochlorothiazide', 'aspirin 81 mg, atorvastatin', 'minimal non-pharmacological care, while those in the intervention arm received polypill in addition to minimal care']","['adverse events, compliance, non-cardiovascular mortality, changes in blood pressure, fasting blood sugar, and lipids after five years of follow-up', 'acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, sudden cardiac death, new-onset heart failure, coronary artery revascularization procedures, transient ischemic attack, cerebrovascular accidents (fatal or non-fatal), and hospitalization due to any of the mentioned conditions']","[{'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0983882', 'cui_str': 'Aspirin 81 MG'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0085298', 'cui_str': 'Sudden cardiac death'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",4415.0,0.193684,"The secondary outcomes of the study include adverse events, compliance, non-cardiovascular mortality, changes in blood pressure, fasting blood sugar, and lipids after five years of follow-up.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Malekzadeh', 'Affiliation': 'Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Teheran, Iran.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Gandomkar', 'Affiliation': 'Non-Communicable Disease Research Center, Shiraz University of medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zinab', 'Initials': 'Z', 'LastName': 'Malekzadeh', 'Affiliation': 'Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Teheran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Poustchi', 'Affiliation': 'Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Teheran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Moghadami', 'Affiliation': 'Non-Communicable Disease Research Center, Shiraz University of medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Fattahi', 'Affiliation': 'Gastroenterohepatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Moini', 'Affiliation': 'Gastroenterohepatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Anushiravani', 'Affiliation': 'Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Teheran, Iran.'}, {'ForeName': 'Roozbeh', 'Initials': 'R', 'LastName': 'Mortazavi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shahrokh', 'Initials': 'S', 'LastName': 'Sadeghi Boogar', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Mohammadkarimi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Abtahi', 'Affiliation': 'Department of Cardiology, Cardiovascular Research Center School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Merat', 'Affiliation': 'Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Teheran, Iran.'}, {'ForeName': 'Sadaf G', 'Initials': 'SG', 'LastName': 'Sepanlou', 'Affiliation': 'Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Teheran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Malekzadeh', 'Affiliation': 'Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Teheran, Iran.'}]",Archives of Iranian medicine,['10.34172/aim.2020.58']
1537,32895874,Efficacy of oral rosuvastatin intervention on HDL and its associated proteins in men with type 2 diabetes mellitus.,"PURPOSE


High-density lipoprotein (HDL) undergoes structural and functional modification in patients with type 2 diabetes mellitus (T2DM). There are limited data on effect of rosuvastatin on HDL-associated proteins and the antiatherogenic effects of rosuvastatin. The present study intended to study the efficacy of rosuvastatin intervention on HDL-associated proteins and its other antiatherogenic effects in men with T2DM.
METHODS


Men with T2DM on oral antidiabetic treatment, with LDL-C levels > 75 mg/dL and willing for rosuvastatin intervention (20 mg/day orally for a period of 12 weeks), were included. Fasting glucose, lipid profile were measured using standard methods. Oxidized low-density lipoprotein (oxLDL), oxidized HDL (oxHDL), paraoxonase-1 (PON-1), tumour necrosis factor-α (TNF-α) and lecithin:cholesterol acyltransferase (LCAT) in serum were measured by ELISA; serum myeloperoxidase (MPO) by spectrophotometric method and cholesterol efflux by fluorometric assay. Carotid intima-media thickness (cIMT) measurement to assess vascular health status was done using doppler.
RESULTS


Rosuvastatin produced a significant decrease (p < 0.05) in lipids (total cholesterol, triglycerides, LDL-C); oxidative stress (oxLDL, oxHDL, MPO); inflammation (TNF-α); LCAT concentration; cIMT; significant increase in antiatherogenic HDL and cholesterol efflux (p < 0.05) and no change in apoA-I levels from baseline to 12 weeks of follow-up. A decrease in MPO activity was found to be independently associated with an increase in cholesterol efflux.
CONCLUSIONS


Post intervention there is a quantitative and qualitative improvement in HDL, which helps in its reverse cholesterol transport (RCT) and antioxidant functions. Improvement in HDL functions and suppression of inflammation by rosuvastatin lead to regression in cIMT, which is beneficial in decreasing the progression of cardiovascular disease (CVD) in men with diabetes.",2020,"RESULTS


Rosuvastatin produced a significant decrease (p < 0.05) in lipids (total cholesterol, triglycerides, LDL-C); oxidative stress (oxLDL, oxHDL, MPO); inflammation (TNF-α); LCAT concentration; cIMT; significant increase in antiatherogenic HDL and cholesterol efflux (p < 0.05) and no change in apoA-I levels from baseline to 12 weeks of follow-up.","['men with diabetes', 'patients with type 2 diabetes mellitus (T2DM', 'men with type 2 diabetes mellitus', 'Men with T2DM on oral antidiabetic treatment, with LDL-C levels\u2009', 'men with T2DM']","['Carotid intima-media thickness (cIMT) measurement', 'Rosuvastatin', 'rosuvastatin', 'rosuvastatin intervention', 'oral rosuvastatin intervention']","['antiatherogenic HDL and cholesterol efflux', 'MPO activity', 'Fasting glucose, lipid profile', 'cholesterol efflux', 'Oxidized low-density lipoprotein (oxLDL), oxidized HDL (oxHDL), paraoxonase-1', 'PON-1), tumour necrosis factor-α (TNF-α) and lecithin:cholesterol acyltransferase (LCAT) in serum', 'lipids (total cholesterol, triglycerides, LDL-C); oxidative stress (oxLDL, oxHDL, MPO); inflammation (TNF-α); LCAT concentration; cIMT']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C1121571', 'cui_str': 'Paraoxonase 1'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0031617', 'cui_str': 'Lecithin'}, {'cui': 'C0008380', 'cui_str': 'Cholesterol acyltransferase'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",,0.0204753,"RESULTS


Rosuvastatin produced a significant decrease (p < 0.05) in lipids (total cholesterol, triglycerides, LDL-C); oxidative stress (oxLDL, oxHDL, MPO); inflammation (TNF-α); LCAT concentration; cIMT; significant increase in antiatherogenic HDL and cholesterol efflux (p < 0.05) and no change in apoA-I levels from baseline to 12 weeks of follow-up.","[{'ForeName': 'Sriram', 'Initials': 'S', 'LastName': 'Naresh', 'Affiliation': 'Department of Biochemistry, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, 517507, India.'}, {'ForeName': 'Aparna R', 'Initials': 'AR', 'LastName': 'Bitla', 'Affiliation': 'Department of Biochemistry, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, 517507, India. aparnabitla@yahoo.co.in.'}, {'ForeName': 'P V L N Srinivasa', 'Initials': 'PVLNS', 'LastName': 'Rao', 'Affiliation': 'Department of Biochemistry, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, 517507, India.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Sachan', 'Affiliation': 'Department of Endocrinology and Metabolism, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, 517507, India.'}, {'ForeName': 'Yadagiri Lakshmi', 'Initials': 'YL', 'LastName': 'Amancharla', 'Affiliation': 'Department of Radiology, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, 517507, India.'}]",Endocrine,['10.1007/s12020-020-02472-5']
1538,32896292,Azithromycin in addition to standard of care versus standard of care alone in the treatment of patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II): a randomised clinical trial.,"BACKGROUND


The efficacy and safety of azithromycin in the treatment of COVID-19 remain uncertain. We assessed whether adding azithromycin to standard of care, which included hydroxychloroquine, would improve clinical outcomes of patients admitted to the hospital with severe COVID-19.
METHODS


We did an open-label, randomised clinical trial at 57 centres in Brazil. We enrolled patients admitted to hospital with suspected or confirmed COVID-19 and at least one additional severity criteria as follows: use of oxygen supplementation of more than 4 L/min flow; use of high-flow nasal cannula; use of non-invasive mechanical ventilation; or use of invasive mechanical ventilation. Patients were randomly assigned (1:1) to azithromycin (500 mg via oral, nasogastric, or intravenous administration once daily for 10 days) plus standard of care or to standard of care without macrolides. All patients received hydroxychloroquine (400 mg twice daily for 10 days) because that was part of standard of care treatment in Brazil for patients with severe COVID-19. The primary outcome, assessed by an independent adjudication committee masked to treatment allocation, was clinical status at day 15 after randomisation, assessed by a six-point ordinal scale, with levels ranging from 1 to 6 and higher scores indicating a worse condition (with odds ratio [OR] greater than 1·00 favouring the control group). The primary outcome was assessed in all patients in the intention-to-treat (ITT) population who had severe acute respiratory syndrome coronavirus 2 infection confirmed by molecular or serological testing before randomisation (ie, modified ITT [mITT] population). Safety was assessed in all patients according to which treatment they received, regardless of original group assignment. This trial was registered at ClinicalTrials.gov, NCT04321278.
FINDINGS


447 patients were enrolled from March 28 to May 19, 2020. COVID-19 was confirmed in 397 patients who constituted the mITT population, of whom 214 were assigned to the azithromycin group and 183 to the control group. In the mITT population, the primary endpoint was not significantly different between the azithromycin and control groups (OR 1·36 [95% CI 0·94-1·97], p=0·11). Rates of adverse events, including clinically relevant ventricular arrhythmias, resuscitated cardiac arrest, acute kidney failure, and corrected QT interval prolongation, were not significantly different between groups.
INTERPRETATION


In patients with severe COVID-19, adding azithromycin to standard of care treatment (which included hydroxychloroquine) did not improve clinical outcomes. Our findings do not support the routine use of azithromycin in combination with hydroxychloroquine in patients with severe COVID-19.
FUNDING


COALITION COVID-19 Brazil and EMS.",2020,"Rates of adverse events, including clinically relevant ventricular arrhythmias, resuscitated cardiac arrest, acute kidney failure, and corrected QT interval prolongation, were not significantly different between groups.
","['patients with severe COVID-19', '57 centres in Brazil', '447 patients were enrolled from March 28 to May 19, 2020', '397 patients who constituted the mITT population', 'enrolled patients admitted to hospital with suspected or confirmed COVID-19 and at least one additional severity criteria as follows: use of', 'patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II', 'population who had severe acute respiratory syndrome coronavirus 2 infection confirmed by molecular or serological testing before randomisation ', 'patients admitted to the hospital with severe COVID-19']","['hydroxychloroquine', 'azithromycin (500 mg via oral, nasogastric, or intravenous administration once daily for 10 days) plus standard of care or to standard of care without macrolides', 'oxygen supplementation of more than 4 L/min flow; use of high-flow nasal cannula; use of non-invasive mechanical ventilation', 'azithromycin', 'Azithromycin', 'invasive mechanical ventilation']","['intention-to-treat (ITT', 'Safety', 'Rates of adverse events, including clinically relevant ventricular arrhythmias, resuscitated cardiac arrest, acute kidney failure, and corrected QT interval prolongation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0694637', 'cui_str': 'Nasogastric route'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0003240', 'cui_str': 'Macrolide antibiotic product'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}]","[{'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",447.0,0.343065,"Rates of adverse events, including clinically relevant ventricular arrhythmias, resuscitated cardiac arrest, acute kidney failure, and corrected QT interval prolongation, were not significantly different between groups.
","[{'ForeName': 'Remo H M', 'Initials': 'RHM', 'LastName': 'Furtado', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil; Instituto do Coração, Hospital das Clinicas da Faculdade de Medicina, Universidade de São Paulo, Brazil.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil. Electronic address: otavio.berwanger@einstein.br.'}, {'ForeName': 'Henrique A', 'Initials': 'HA', 'LastName': 'Fonseca', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Thiago D', 'Initials': 'TD', 'LastName': 'Corrêa', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil; Brazilian Research in Intensive Care Network, São Paulo, Brazil.'}, {'ForeName': 'Leonardo R', 'Initials': 'LR', 'LastName': 'Ferraz', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Maura G', 'Initials': 'MG', 'LastName': 'Lapa', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Zampieri', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil; HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Viviane C', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil; BP-A Beneficência Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luciano C P', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil; Hospital Sírio Libanês Research and Education Institute, São Paulo, Brazil.'}, {'ForeName': 'Regis G', 'Initials': 'RG', 'LastName': 'Rosa', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil; Hospital Moinhos de Vento, Porto Alegre, Brazil.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil; Duke University Medical Centre, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'International Research Center, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil.'}, {'ForeName': 'Airton L O', 'Initials': 'ALO', 'LastName': 'Manoel', 'Affiliation': 'Hospital Moyses Deustche (MBoi Mirim), São Paulo, Brazil.'}, {'ForeName': 'Felipe M T', 'Initials': 'FMT', 'LastName': 'Piza', 'Affiliation': 'Hospital Moyses Deustche (MBoi Mirim), São Paulo, Brazil.'}, {'ForeName': 'Priscilla A', 'Initials': 'PA', 'LastName': 'Martins', 'Affiliation': 'Hospital Estadual Jayme dos Santos Neves, Serra, Brazil.'}, {'ForeName': 'Thiago C', 'Initials': 'TC', 'LastName': 'Lisboa', 'Affiliation': 'Hospital de Clínicas, Porto Alegre, Brazil.'}, {'ForeName': 'Adriano J', 'Initials': 'AJ', 'LastName': 'Pereira', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil; Hospital Vila Santa Catarina, São Paulo, Brazil.'}, {'ForeName': 'Guilherme B', 'Initials': 'GB', 'LastName': 'Olivato', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil; Hospital Vila Santa Catarina, São Paulo, Brazil.'}, {'ForeName': 'Vicente C S', 'Initials': 'VCS', 'LastName': 'Dantas', 'Affiliation': 'Hospital Naval Marcílio Dias, Rio de Janeiro, Brazil.'}, {'ForeName': 'Eveline P', 'Initials': 'EP', 'LastName': 'Milan', 'Affiliation': 'Hospital Giselda Trigueiro, Natal, Brazil.'}, {'ForeName': 'Otavio C E', 'Initials': 'OCE', 'LastName': 'Gebara', 'Affiliation': 'Hospital Santa Paula, São Paulo, Brazil.'}, {'ForeName': 'Roberto B', 'Initials': 'RB', 'LastName': 'Amazonas', 'Affiliation': 'EMS Pharma, Hortolândia, Brazil.'}, {'ForeName': 'Monalisa B', 'Initials': 'MB', 'LastName': 'Oliveira', 'Affiliation': 'EMS Pharma, Hortolândia, Brazil.'}, {'ForeName': 'Ronaldo V P', 'Initials': 'RVP', 'LastName': 'Soares', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Diogo D F', 'Initials': 'DDF', 'LastName': 'Moia', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Luciana P A', 'Initials': 'LPA', 'LastName': 'Piano', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Kleber', 'Initials': 'K', 'LastName': 'Castilho', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Roberta G R A P', 'Initials': 'RGRAP', 'LastName': 'Momesso', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Guilherme P P', 'Initials': 'GPP', 'LastName': 'Schettino', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Luiz Vicente', 'Initials': 'LV', 'LastName': 'Rizzo', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Ary Serpa', 'Initials': 'AS', 'LastName': 'Neto', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil; Brazilian Research in Intensive Care Network, São Paulo, Brazil; Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Flávia R', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil; Department of Anesthesiology, Pain and Intensive Care Medicine, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil; HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31862-6']
1539,32896753,Proprioceptive neuromuscular facilitation in the functionality and lymphatic circulation of the upper limb of women undergoing breast cancer treatment.,"BACKGROUND


With the increase in survival of women treated for breast cancer, it is necessary to evaluate the effect of therapeutic resources on co-morbidities resulting from the surgical treatment of the disease. The aim of this study was to evaluate the effects of proprioceptive neuromuscular facilitation on the functionality and lymphatic circulation of the upper limb involved in the treatment of breast cancer.
METHODS


The study was conducted according to randomized clinical trial design. Thirty-two women at a mean age of 52.20 (±8.32) years, submitted to breast cancer treatment, divided into two groups, control - women submitted to standard breast cancer treatment, and treated group, composed of women who underwent breast cancer treatment and rehabilitation with the proprioceptive neuromuscular facilitation technique. Palmar grip strength with dynamometer and shoulder range of motion with goniometer were evaluated. Lymphatic circulation analysis was performed in a computerized scintillation chamber, before and after therapeutic intervention.
FINDINGS


In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
INTERPRETATION


The results obtained in this study allow us to conclude that proprioceptive neuromuscular facilitation favors an increase in muscle strength, range of motion, but not in lymphatic flow, in women undergoing surgical treatment for breast cancer.",2020,"In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
","['women undergoing surgical treatment for breast cancer', 'women undergoing breast cancer treatment', 'Thirty-two women at a mean age of 52.20 (±8.32) years, submitted to breast cancer treatment']","['proprioceptive neuromuscular facilitation', 'Proprioceptive neuromuscular facilitation', 'breast cancer treatment and rehabilitation with the proprioceptive neuromuscular facilitation technique', 'control - women submitted to standard breast cancer treatment']","['muscle strength, range of motion', 'palmar grip strength', 'internal rotation', 'lymphatic flow', 'range of motion of flexion', 'Palmar grip strength with dynamometer and shoulder range of motion with goniometer', 'external rotation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0454481', 'cui_str': 'Proprioceptive neuromuscular facilitation technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0575813', 'cui_str': 'Palmar grip'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}]",32.0,0.0146829,"In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
","[{'ForeName': 'Daniela Santana Polati', 'Initials': 'DSP', 'LastName': 'da Silveira', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil. Electronic address: daniela.silveira@unifran.edu.br.'}, {'ForeName': 'Marcelo José', 'Initials': 'MJ', 'LastName': 'Dos Santos', 'Affiliation': 'Departament of Nuclear Medicine, Câncer Hospital of Barretos, Barretos, SP, Brazil.'}, {'ForeName': 'Eduardo Tinóis', 'Initials': 'ET', 'LastName': 'da Silva', 'Affiliation': 'Departament of Physics in Nuclear Medicine, Radiation Safety and Technology Institute, Campinas, SP, Brazil.'}, {'ForeName': 'Almir José', 'Initials': 'AJ', 'LastName': 'Sarri', 'Affiliation': 'Departament of Physiotherapy, Câncer Hospital of Barretos, Barretos, SP, Brazil.'}, {'ForeName': 'Lais Mara Siqueira', 'Initials': 'LMS', 'LastName': 'das Neves', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Elaine Caldeira de Oliveira', 'Initials': 'ECO', 'LastName': 'Guirro', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil; Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil. Electronic address: ecguirro@fmrp.usp.br.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105158']
1540,32896776,The long-term influence of hospital and surgeon volume on local control and survival in the randomized German Rectal Cancer Trial CAO/ARO/AIO-94.,"BACKGROUND


The association of treatment volume and oncological outcome of rectal cancer patients undergoing multidisciplinary treatment is subject of an ongoing debate. Prospective data on long-term local control and overall survival (OS) are not available so far. This study investigated the long-term influence of hospital and surgeon volume on local recurrence (LR) and OS in patients with locally advanced rectal cancers.
METHODS


In a post-hoc analysis of the randomized phase III CAO/ARO/AIO-94 trial after a follow-up of more than 10 years, 799 patients with stage II/III rectal cancers were evaluated. LR-rates and OS were stratified by hospital recruitment volume (≤20 vs. 21-90 vs. >90 patients) and by surgeon volume (≤10 vs. 11-50 vs. >50 procedures).
RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03). The surgeon volume was adversely associated with LR (p = 0.01) but had no influence on overall survival. The positive effect of neoadjuvant chemoradiation (CRT) on local control was the strongest in patients being operated by medium-volume surgeons, less in patients being operated by high-volume surgeons and missing in those being operated by low-volume surgeons.
CONCLUSIONS


Patients with locally advanced rectal cancers might benefit from treatment in specialized high-volume hospitals. In particular, the surgeon volume had significant influence on long-term local tumour control. The effect of neoadjuvant CRT on local tumour control may likewise depend on the surgeon volume.",2020,"RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03).","['799 patients with stage II/III rectal cancers', 'Patients with locally advanced rectal cancers', 'patients with locally advanced rectal cancers', 'rectal cancer patients undergoing']","['neoadjuvant CRT', 'multidisciplinary treatment', 'neoadjuvant chemoradiation (CRT']","['overall survival (OS', 'LR-rates and OS', 'longer OS', 'long-term local tumour control', 'local control and survival', 'overall survival', 'local recurrence (LR) and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",799.0,0.0971685,"RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03).","[{'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Sprenger', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany. Electronic address: thilo.sprenger@chiru.med.uni-giessen.de.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Beißbarth', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Sauer', 'Affiliation': 'Department of Radiotherapy, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Tschmelitsch', 'Affiliation': 'Department of Surgery, Krankenhaus der Barmherzigen Brüder, St. Veit an der Glan, Austria.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiotherapy, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Hohenberger', 'Affiliation': 'Department of Surgery, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Staib', 'Affiliation': 'Department of General and Visceral Surgery, Klinikum Esslingen, Esslingen, Germany.'}, {'ForeName': 'Hans-Rudolf', 'Initials': 'HR', 'LastName': 'Raab', 'Affiliation': 'University Department of General and Visceral Surgery, Klinikum Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'Department of Radiotherapy and Oncology, University Medical Center Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.021']
1541,32873114,Placebo effects on the quantity and quality of relaxation training.,"Many people find it difficult to practice progressive muscle relaxation (PMR) regularly. We attempted to improve relaxation quantity (i.e. adherence), and relaxation quality via placebo. A total of 100 women were randomly assigned to a standard group, which practiced PMR at home every day for two weeks, or a placebo group, which practiced PMR for two weeks with additional daily placebo treatment. To monitor adherence to relaxation practice, we used a smartphone app. The placebo group practiced more often than the standard group. Both groups did not differ in their reported relaxation level after the daily exercises.",2020,The placebo group practiced more often than the standard group.,['A total of 100 women'],"['placebo', 'Placebo', 'placebo treatment']","['quantity and quality of relaxation training', 'relaxation level', 'relaxation quantity (i.e. adherence), and relaxation quality']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",100.0,0.2711,The placebo group practiced more often than the standard group.,"[{'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Höfler', 'Affiliation': 'Department of Clinical Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Osmani', 'Affiliation': 'Department of Clinical Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schienle', 'Affiliation': 'Department of Clinical Psychology, University of Graz, Graz, Austria.'}]",Journal of health psychology,['10.1177/1359105320954238']
1542,32873573,Targeted Natural Killer Cell-Based Adoptive Immunotherapy for the Treatment of Patients with NSCLC after Radiochemotherapy: A Randomized Phase II Clinical Trial.,"PURPOSE


Non-small cell lung cancer (NSCLC) is a fatal disease with poor prognosis. A membrane-bound form of Hsp70 (mHsp70) which is selectively expressed on high-risk tumors serves as a target for mHsp70-targeting natural killer (NK) cells. Patients with advanced mHsp70-positive NSCLC may therefore benefit from a therapeutic intervention involving mHsp70-targeting NK cells. The randomized phase II clinical trial (EudraCT2008-002130-30) explores tolerability and efficacy of  ex vivo -activated NK cells in patients with NSCLC after radiochemotherapy (RCT).
PATIENTS AND METHODS


Patients with unresectable, mHsp70-positive NSCLC (stage IIIa/b) received 4 cycles of autologous NK cells activated  ex vivo  with TKD/IL2 [interventional arm (INT)] after RCT (60-70 Gy, platinum-based chemotherapy) or RCT alone [control arm (CTRL)]. The primary objective was progression-free survival (PFS), and secondary objectives were the assessment of quality of life (QoL, QLQ-LC13), toxicity, and immunobiological responses.
RESULTS


The NK-cell therapy after RCT was well tolerated, and no differences in QoL parameters between the two study arms were detected. Estimated 1-year probabilities for PFS were 67% [95% confidence interval (CI), 19%-90%] for the INT arm and 33% (95% CI, 5%-68%) for the CTRL arm ( P  = 0.36, 1-sided log-rank test). Clinical responses in the INT group were associated with an increase in the prevalence of activated NK cells in their peripheral blood.
CONCLUSIONS


Ex vivo  TKD/IL2-activated, autologous NK cells are well tolerated and deliver positive clinical responses in patients with advanced NSCLC after RCT.",2020,"RESULTS


The NK-cell therapy after RCT was well tolerated, and no differences in QoL parameters between the two study arms were detected.","['Patients with advanced mHsp70-positive NSCLC', 'patients with advanced NSCLC after RCT', 'patients with NSCLC after radiochemotherapy (RCT', 'Patients with NSCLC after Radiochemotherapy', 'Patients with unresectable, mHsp70-positive NSCLC']","['ex vivo -activated', 'Targeted Natural Killer Cell-Based Adoptive Immunotherapy', 'Ex vivo  TKD', 'RCT alone [control arm (CTRL', 'autologous NK cells activated  ex vivo  with TKD/IL2 [interventional arm (INT)] after RCT']","['Estimated 1-year probabilities for PFS', 'tolerability and efficacy', 'progression-free survival (PFS), and secondary objectives were the assessment of quality of life (QoL, QLQ-LC13), toxicity, and immunobiological responses', 'prevalence of activated NK cells', 'QoL parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0243043', 'cui_str': 'Heat-Shock Proteins 70'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.176916,"RESULTS


The NK-cell therapy after RCT was well tolerated, and no differences in QoL parameters between the two study arms were detected.","[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Multhoff', 'Affiliation': 'Department Radiation Oncology, Klinikum rechts der Isar, TU München, (TUM), Munich, Germany. gabriele.multhoff@tum.de.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Seier', 'Affiliation': 'Department Radiation Oncology, Klinikum rechts der Isar, TU München, (TUM), Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Stangl', 'Affiliation': 'Radiation Immuno-Oncology, Center for Translational Cancer Research TUM (TranslaTUM), Munich, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Sievert', 'Affiliation': 'Radiation Immuno-Oncology, Center for Translational Cancer Research TUM (TranslaTUM), Munich, Germany.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Shevtsov', 'Affiliation': 'Radiation Immuno-Oncology, Center for Translational Cancer Research TUM (TranslaTUM), Munich, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Werner', 'Affiliation': 'Radiation Immuno-Oncology, Center for Translational Cancer Research TUM (TranslaTUM), Munich, Germany.'}, {'ForeName': 'A Graham', 'Initials': 'AG', 'LastName': 'Pockley', 'Affiliation': 'John van Geest Cancer Research Centre, Nottingham Trent University, Nottingham, United Kingdom; and multimmune GmbH, Munich, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Blankenstein', 'Affiliation': 'Münchner Studienzentrum CCC, TUM, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hildebrandt', 'Affiliation': 'TUMCells, TUM School of Medicine, Munich, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Offner', 'Affiliation': 'Department of Transfusion Medicine, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Ahrens', 'Affiliation': 'Department of Transfusion Medicine, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Kokowski', 'Affiliation': 'Pneumology and Pneumologic Oncology, Klinikum Bogenhausen, Munich, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hautmann', 'Affiliation': 'Department of Radiation Oncology, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'Department of Radiotherapy and Oncology, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiation Oncology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Lubgan', 'Affiliation': 'Department of Radiation Oncology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Huber', 'Affiliation': 'Division of Respiratory Medicine and Thoracic Oncology Centre Munich and Thoracic Oncology Centre Munich, University München, LMU, Munich, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Hautmann', 'Affiliation': 'Pneumology Group Med I, Klinikum rechts der Isar, TUM, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Duell', 'Affiliation': 'Asklepios Lung Hospital München-Gauting, Thoracal Pneumology, LMU, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Molls', 'Affiliation': 'Department Radiation Oncology, Klinikum rechts der Isar, TU München, (TUM), Munich, Germany.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Specht', 'Affiliation': 'Department Radiation Oncology, Klinikum rechts der Isar, TU München, (TUM), Munich, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Haller', 'Affiliation': 'Institute of Medical Informatics, Statistics and Epidemiology, TUM, Munich, Germany.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Devecka', 'Affiliation': 'Department Radiation Oncology, Klinikum rechts der Isar, TU München, (TUM), Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Sauter', 'Affiliation': 'Institute of Radiology, TUM, Munich, Germany.'}, {'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Combs', 'Affiliation': 'Department Radiation Oncology, Klinikum rechts der Isar, TU München, (TUM), Munich, Germany.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1141']
1543,32875505,Impact of Clinical Decision Support on Antibiotic Prescribing for Acute Respiratory Infections: a Cluster Randomized Implementation Trial.,"BACKGROUND


Clinical decision support (CDS) is a promising tool for reducing antibiotic prescribing for acute respiratory infections (ARIs).
OBJECTIVE


To assess the impact of previously effective CDS on antibiotic-prescribing rates for ARIs when adapted and implemented in diverse primary care settings.
DESIGN


Cluster randomized clinical trial (RCT) implementing a CDS tool designed to guide evidence-based evaluation and treatment of streptococcal pharyngitis and pneumonia.
SETTING


Two large academic health system primary care networks with a mix of providers.
PARTICIPANTS


All primary care practices within each health system were invited. All providers within participating clinic were considered a participant. Practices were randomized selection to a control or intervention group.
INTERVENTIONS


Intervention practice providers had access to an integrated clinical prediction rule (iCPR) system designed to determine the risk of bacterial infection from reason for visit of sore throat, cough, or upper respiratory infection and guide evidence-based evaluation and treatment.
MAIN OUTCOME(S)


Change in overall antibiotic prescription rates.
MEASURE(S)


Frequency, rates, and type of antibiotics prescribed in intervention and controls groups.
RESULTS


33 primary care practices participated with 541 providers and 100,573 patient visits. Intervention providers completed the tool in 6.9% of eligible visits. Antibiotics were prescribed in 35% and 36% of intervention and control visits, respectively, showing no statistically significant difference. There were also no differences in rates of orders for rapid streptococcal tests (RR, 0.94; P = 0.11) or chest X-rays (RR, 1.01; P = 0.999) between groups.
CONCLUSIONS


The iCPR tool was not effective in reducing antibiotic prescription rates for upper respiratory infections in diverse primary care settings. This has implications for the generalizability of CDS tools as they are adapted to heterogeneous clinical contexts.
TRIAL REGISTRATION


Clinicaltrials.gov (NCT02534987). Registered August 26, 2015 at https://clinicaltrials.gov.",2020,"There were also no differences in rates of orders for rapid streptococcal tests (RR, 0.94; P = 0.11) or chest X-rays (RR, 1.01; P = 0.999) between groups.
","['All primary care practices within each health system were invited', '33 primary care practices participated with 541 providers and 100,573 patient visits', 'Acute Respiratory Infections', 'Two large academic health system primary care networks with a mix of providers']","['Intervention practice providers had access to an integrated clinical prediction rule (iCPR) system designed to determine the risk of bacterial infection from reason for visit of sore throat, cough, or upper respiratory infection and guide evidence-based evaluation and treatment']","['antibiotic prescription rates', 'overall antibiotic prescription rates', 'Antibiotics', 'rates of orders for rapid streptococcal tests']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3179496', 'cui_str': 'Clinical Prediction Rule'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004623', 'cui_str': 'Bacterial infectious disease'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1868901', 'cui_str': 'Rapid streptococcal test'}]",,0.170395,"There were also no differences in rates of orders for rapid streptococcal tests (RR, 0.94; P = 0.11) or chest X-rays (RR, 1.01; P = 0.999) between groups.
","[{'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Mann', 'Affiliation': 'New York University School of Medicine, New York, NY, USA. Devin.Mann@nyulangone.org.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hess', 'Affiliation': 'University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McGinn', 'Affiliation': 'Hofstra Northwell School of Medicine, New York, NY, USA.'}, {'ForeName': 'Safiya', 'Initials': 'S', 'LastName': 'Richardson', 'Affiliation': 'Hofstra Northwell School of Medicine, New York, NY, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Palmisano', 'Affiliation': 'Boston University, Boston, MA, USA.'}, {'ForeName': 'Sara Kuppin', 'Initials': 'SK', 'LastName': 'Chokshi', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Mishuris', 'Affiliation': 'Boston University, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'McCullagh', 'Affiliation': 'Hofstra Northwell School of Medicine, New York, NY, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Dinh-Le', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Feldstein', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06096-3']
1544,32871529,"Changes in glenohumeral translation, electromyographic activity, and pressure-pain thresholds following sustained or oscillatory mobilizations in stiff and healthy shoulders: Results of a randomized, controlled laboratory trial.","STUDY DESIGN


Randomized Controlled Laboratory Study.
BACKGROUND


Posterior glide glenohumeral (GH) mobilizations are utilized to improve motion and decrease pain in patients with shoulder pathologies, thought to be due to capsular stretch and neurophysiologic effects. However, it remains unclear how different GH mobilizations influence mobility, rotator cuff (RC) activity, and pain processing, or if effects are different in stiff (≥15-degree loss of passive motion in any plane) rather than healthy shoulders.
OBJECTIVES


To compare the effects of oscillatory and sustained posterior GH mobilizations on translation, RC activity, and pressure pain threshold (PPT) in stiff and healthy shoulders.
METHODS


Eighty-eight participants, (44 control, 44 stiff shoulders) were randomly assigned to one of two mobilization conditions. Pre-post intervention measurements of PPT, GH translation via ultrasound imaging, and RC activity assessed via electromyography were performed. Sustained or oscillatory grade III posterior GH mobilizations were then provided to all participants. Data were analyzed using tests of difference and regression modeling.
RESULTS


Sustained glides (2.8 ± 3.3 mm) demonstrated significantly greater changes in translation compared to oscillatory glides (1.1 ± 3.9 mm), p = .028. Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01). Small changes in PPT occurred across all conditions, none reaching clinically meaningful levels.
CONCLUSION


Sustained mobilizations resulted in greater changes in GH translation. RC activity was higher in the stiff shoulder group, and remained higher post-intervention despite gains in GH translation, suggesting a mechanical rather than neurophysiologic effect. There was no meaningful difference in PPT between modes of mobilization.
LEVEL OF EVIDENCE


Therapy, Randomized Controlled Laboratory Study, Level 1b.",2020,"Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01).","['stiff and healthy shoulders', 'patients with shoulder pathologies', 'Eighty-eight participants, (44 control, 44 stiff shoulders']","['Posterior glide glenohumeral (GH) mobilizations', 'sustained or oscillatory mobilizations', 'oscillatory and sustained posterior GH mobilizations']","['glenohumeral translation, electromyographic activity, and pressure-pain thresholds', 'GH translation', 'RC activity', 'PPT, GH translation via ultrasound imaging, and RC activity assessed via electromyography', 'PPT', 'total RC activity', 'mobility, rotator cuff (RC) activity, and pain processing', 'translation, RC activity, and pressure pain threshold (PPT']","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0241042', 'cui_str': 'Shoulder stiff'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}]","[{'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",88.0,0.18114,"Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01).","[{'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Swanson', 'Affiliation': 'University of Hartford, West Hartford, CT, USA; University of New England, Portland, ME, USA. Electronic address: bswanson@Hartford.edu.'}, {'ForeName': 'J Adrienne', 'Initials': 'JA', 'LastName': 'McAuley', 'Affiliation': 'University of New England, Portland, ME, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lawrence', 'Affiliation': 'University of New England, Portland, ME, USA.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102243']
1545,32871100,"Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


Cardiac muscle hypercontractility is a key pathophysiological abnormality in hypertrophic cardiomyopathy, and a major determinant of dynamic left ventricular outflow tract (LVOT) obstruction. Available pharmacological options for hypertrophic cardiomyopathy are inadequate or poorly tolerated and are not disease-specific. We aimed to assess the efficacy and safety of mavacamten, a first-in-class cardiac myosin inhibitor, in symptomatic obstructive hypertrophic cardiomyopathy.
METHODS


In this phase 3, randomised, double-blind, placebo-controlled trial (EXPLORER-HCM) in 68 clinical cardiovascular centres in 13 countries, patients with hypertrophic cardiomyopathy with an LVOT gradient of 50 mm Hg or greater and New York Heart Association (NYHA) class II-III symptoms were assigned (1:1) to receive mavacamten (starting at 5 mg) or placebo for 30 weeks. Visits for assessment of patient status occurred every 2-4 weeks. Serial evaluations included echocardiogram, electrocardiogram, and blood collection for laboratory tests and mavacamten plasma concentration. The primary endpoint was a 1·5 mL/kg per min or greater increase in peak oxygen consumption (pVO 2 ) and at least one NYHA class reduction or a 3·0 mL/kg per min or greater pVO 2  increase without NYHA class worsening. Secondary endpoints assessed changes in post-exercise LVOT gradient, pVO 2 , NYHA class, Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS), and Hypertrophic Cardiomyopathy Symptom Questionnaire Shortness-of-Breath subscore (HCMSQ-SoB). This study is registered with ClinicalTrials.gov, NCT03470545.
FINDINGS


Between May 30, 2018, and July 12, 2019, 429 adults were assessed for eligibility, of whom 251 (59%) were enrolled and randomly assigned to mavacamten (n=123 [49%]) or placebo (n=128 [51%]). 45 (37%) of 123 patients on mavacamten versus 22 (17%) of 128 on placebo met the primary endpoint (difference +19·4%, 95% CI 8·7 to 30·1; p=0·0005). Patients on mavacamten had greater reductions than those on placebo in post-exercise LVOT gradient (-36 mm Hg, 95% CI -43·2 to -28·1; p<0·0001), greater increase in pVO 2  (+1·4 mL/kg per min, 0·6 to 2·1; p=0·0006), and improved symptom scores (KCCQ-CSS +9·1, 5·5 to 12·7; HCMSQ-SoB -1·8, -2·4 to -1·2; p<0·0001). 34% more patients in the mavacamten group improved by at least one NYHA class (80 of 123 patients in the mavacamten group vs 40 of 128 patients in the placebo group; 95% CI 22·2 to 45·4; p<0·0001). Safety and tolerability were similar to placebo. Treatment-emergent adverse events were generally mild. One patient died by sudden death in the placebo group.
INTERPRETATION


Treatment with mavacamten improved exercise capacity, LVOT obstruction, NYHA functional class, and health status in patients with obstructive hypertrophic cardiomyopathy. The results of this pivotal trial highlight the benefits of disease-specific treatment for this condition.
FUNDING


MyoKardia.",2020,"Patients on mavacamten had greater reductions than those on placebo in post-exercise LVOT gradient (-36 mm Hg, 95% CI -43·2 to -28·1;","['68 clinical cardiovascular centres in 13 countries, patients with hypertrophic cardiomyopathy with an LVOT gradient of 50 mm Hg or greater and New York Heart Association (NYHA) class II-III symptoms', 'patients with obstructive hypertrophic cardiomyopathy', 'Between May 30, 2018, and July 12, 2019', '429 adults were assessed for eligibility, of whom 251 (59', 'symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM']","['placebo', 'placebo-controlled trial (EXPLORER-HCM', 'mavacamten', 'Mavacamten']","['Safety and tolerability', 'echocardiogram, electrocardiogram, and blood collection for laboratory tests and mavacamten plasma concentration', 'symptom scores', 'exercise capacity, LVOT obstruction, NYHA functional class, and health status', 'changes in post-exercise LVOT gradient, pVO 2 , NYHA class, Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS), and Hypertrophic Cardiomyopathy Symptom Questionnaire Shortness-of-Breath subscore (HCMSQ-SoB', 'sudden death', '1·5 mL/kg per min or greater increase in peak oxygen consumption (pVO 2 ']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007194', 'cui_str': 'Hypertrophic cardiomyopathy'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0450400', 'cui_str': '50mm'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551472', 'cui_str': 'Hypertrophic obstructive cardiomyopathy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0262500', 'cui_str': 'Routine health maintenance'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0262500', 'cui_str': 'Routine health maintenance'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0344917', 'cui_str': 'Left ventricular outflow tract obstruction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0225912', 'cui_str': 'Structure of outflow tract of left ventricle'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C0007194', 'cui_str': 'Hypertrophic cardiomyopathy'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",429.0,0.654238,"Patients on mavacamten had greater reductions than those on placebo in post-exercise LVOT gradient (-36 mm Hg, 95% CI -43·2 to -28·1;","[{'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Olivotto', 'Affiliation': 'Cardiomyopathy Unit, Azienda Ospedaliera Universitaria Careggi, Florence, Italy; University of Florence, Florence, Italy. Electronic address: iacopo.olivotto@unifi.it.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Oreziak', 'Affiliation': '1st Department of Arrhythmia, National Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Barriales-Villa', 'Affiliation': 'Unidad de Cardiopatías Familiares, Instituto de Investigación Biomédica de A Coruña, A Coruña, Spain; Complexo Hospitalario Universitario de A Coruña, A Coruña, Spain; Servizo Galego de Saúde, A Coruña, Spain; Universidade da Coruña, A Coruña, Spain; Centro de Investigación Biomédica en Red, Madrid, Spain.'}, {'ForeName': 'Theodore P', 'Initials': 'TP', 'LastName': 'Abraham', 'Affiliation': 'Division of Cardiology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Masri', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Garcia-Pavia', 'Affiliation': 'Centro de Investigación Biomédica en Red, Madrid, Spain; Department of Cardiology, Hospital Universitario Puerta de Hierro, Madrid, Spain; Universidad Francisco de Vitoria, Pozuelo de Alarcón, Madrid, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Saberi', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Neal K', 'Initials': 'NK', 'LastName': 'Lakdawala', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wheeler', 'Affiliation': 'Department of Medicine, Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Owens', 'Affiliation': 'University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Kubanek', 'Affiliation': 'Department of Cardiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Wojakowski', 'Affiliation': 'Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Morten K', 'Initials': 'MK', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gimeno-Blanes', 'Affiliation': 'Inherited Cardiac Disease Unit, University Hospital Virgen de la Arrixaca, Murcia, Spain.'}, {'ForeName': 'Kia', 'Initials': 'K', 'LastName': 'Afshar', 'Affiliation': 'Intermountain Medical Center Heart Institute, Intermountain Medical Center, Murray, UT, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Myers', 'Affiliation': 'Division of Cardiology, Veterans Affairs Palo Alto Healthcare System, Palo Alto, CA, USA; Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Hegde', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Sehnert', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Wanying', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Mondira', 'Initials': 'M', 'LastName': 'Bhattacharya', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Edelberg', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Cynthia Burstein', 'Initials': 'CB', 'LastName': 'Waldman', 'Affiliation': 'HCMBeat, Los Angeles, CA, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Lester', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Carolyn Y', 'Initials': 'CY', 'LastName': 'Ho', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jacoby', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University, New Haven, CT, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31792-X']
1546,32871238,"""Effect of calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study"".","OBJECTIVE


The vitamin D endocrine system may have a variety of actions on cells and tissues involved in COVID-19 progression especially by decreasing the Acute Respiratory Distress Syndrome. Calcifediol can rapidly increase serum 25OHD concentration. We therefore evaluated the effect of calcifediol treatment, on Intensive Care Unit Admission and Mortality rate among Spanish patients hospitalized for COVID-19.
DESIGN


Parallel pilot randomized open label, double-masked clinical trial.
SETTING


University hospital setting (Reina Sofia University Hospital, Córdoba Spain.) PARTICIPANTS: 76 consecutive patients hospitalized with COVID-19 infection, clinical picture of acute respiratory infection, confirmed by a radiographic pattern of viral pneumonia and by a positive SARS-CoV-2 PCR with CURB65 severity scale (recommending hospital admission in case of total score > 1).
PROCEDURES


All hospitalized patients received as best available therapy the same standard care, (per hospital protocol), of a combination of hydroxychloroquine (400 mg every 12 h on the first day, and 200 mg every 12 h for the following 5 days), azithromycin (500 mg orally for 5 days. Eligible patients were allocated at a 2 calcifediol:1 no calcifediol ratio through electronic randomization on the day of admission to take oral calcifediol (0.532 mg), or not. Patients in the calcifediol treatment group continued with oral calcifediol (0.266 mg) on day 3 and 7, and then weekly until discharge or ICU admission. Outcomes of effectiveness included rate of ICU admission and deaths.
RESULTS


Of 50 patients treated with calcifediol, one required admission to the ICU (2%), while of 26 untreated patients, 13 required admission (50 %) p value X 2  Fischer test p < 0.001. Univariate Risk Estimate Odds Ratio for ICU in patients with Calcifediol treatment versus without Calcifediol treatment: 0.02 (95 %CI 0.002-0.17). Multivariate Risk Estimate Odds Ratio for ICU in patients with Calcifediol treatment vs Without Calcifediol treatment ICU (adjusting by Hypertension and T2DM): 0.03 (95 %CI: 0.003-0.25). Of the patients treated with calcifediol, none died, and all were discharged, without complications. The 13 patients not treated with calcifediol, who were not admitted to the ICU, were discharged. Of the 13 patients admitted to the ICU, two died and the remaining 11 were discharged.
CONCLUSION


Our pilot study demonstrated that administration of a high dose of Calcifediol or 25-hydroxyvitamin D, a main metabolite of vitamin D endocrine system, significantly reduced the need for ICU treatment of patients requiring hospitalization due to proven COVID-19. Calcifediol seems to be able to reduce severity of the disease, but larger trials with groups properly matched will be required to show a definitive answer.",2020,"We therefore evaluated the effect of calcifediol treatment, on Intensive Care Unit Admission and Mortality rate among Spanish patients hospitalized for COVID-19.
","['50 patients treated with', 'patients requiring hospitalization due to proven COVID-19', 'Eligible patients', ' 76 consecutive patients hospitalized with COVID-19 infection, clinical picture of acute respiratory infection, confirmed by a radiographic pattern of viral pneumonia and by a positive SARS-CoV-2 PCR with CURB65 severity scale (recommending hospital admission in case of total score > 1', '13 patients not treated with calcifediol, who were not admitted to the ICU, were discharged', 'All hospitalized patients', 'Spanish patients hospitalized for COVID-19', 'university hospital setting (Reina Sofia University Hospital, Córdoba Spain', 'Patients Hospitalized for COVID-19', '13 patients admitted to the ICU, two died and the remaining 11 were discharged']","['hydroxychloroquine', 'Calcifediol or 25-hydroxyvitamin D', 'azithromycin', 'oral calcifediol', 'Calcifediol', 'calcifediol']","['rate of ICU admission and deaths', 'serum 25OHD concentration', 'Intensive Care Unit Admission and Mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3536597', 'cui_str': 'Patient requires hospitalization'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0032310', 'cui_str': 'Viral pneumonia'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0445270', 'cui_str': 'Sofia'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",13.0,0.0691693,"We therefore evaluated the effect of calcifediol treatment, on Intensive Care Unit Admission and Mortality rate among Spanish patients hospitalized for COVID-19.
","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Entrenas Castillo', 'Affiliation': 'UGC de Neumología, Instituto Maimónides de Investigación Biomédica de Córdoba 9 (IMIBIC). Hospital Universitario Reina Sofía, Universidad de Córdoba, Avda. Menéndez 10 Pidal s/n, 14004 11, Córdoba, Spain.'}, {'ForeName': 'Luis Manuel', 'Initials': 'LM', 'LastName': 'Entrenas Costa', 'Affiliation': 'UGC de Neumología, Instituto Maimónides de Investigación Biomédica de Córdoba 9 (IMIBIC). Hospital Universitario Reina Sofía, Universidad de Córdoba, Avda. Menéndez 10 Pidal s/n, 14004 11, Córdoba, Spain. Electronic address: lmentrenas@uco.es.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Vaquero Barrios', 'Affiliation': 'UGC de Neumología, Instituto Maimónides de Investigación Biomédica de Córdoba 9 (IMIBIC). Hospital Universitario Reina Sofía, Universidad de Córdoba, Avda. Menéndez 10 Pidal s/n, 14004 11, Córdoba, Spain.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Alcalá Díaz', 'Affiliation': 'Departamento de Medicina Interna. IMIBIC, CIBER de Fisiopatología de la Obesidad y la Nutrición. Hospital Universitario Reina Sofía, Universidad de Córdoba, Fundación Progreso y Salud. Avda. Menéndez Pidal s/n, 14004 14, Córdoba, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'López Miranda', 'Affiliation': 'Departamento de Medicina Interna. IMIBIC, CIBER de Fisiopatología de la Obesidad y la Nutrición. Hospital Universitario Reina Sofía, Universidad de Córdoba, Fundación Progreso y Salud. Avda. Menéndez Pidal s/n, 14004 14, Córdoba, Spain.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Bouillon', 'Affiliation': 'Department of Chronic Diseases, Metabolism and Ageing, Laboratory of Clinical and Experimental Endocrinology, KU Leuven, Herestraat, ON1/902, 3000, Leuven, Belgium.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Quesada Gomez', 'Affiliation': 'IMIBIC. CIBER de Fragilidad y Envejecimiento Saludable. Hospital Universitario Reina Sofía, Universidad de Córdoba, Fundación Progreso y Salud. Avda. Menéndez Pidal s/n, 18 14004, Córdoba, Spain.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2020.105751']
1547,32877651,"Efficacy and safety of trimetazidine after percutaneous coronary intervention (ATPCI): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


Angina might persist or reoccur despite successful revascularisation with percutaneous coronary intervention (PCI) and antianginal therapy. Additionally, PCI in stable patients has not been shown to improve survival compared with optimal medical therapy. Trimetazidine is an antianginal agent that improves energy metabolism of the ischaemic myocardium and might improve outcomes and symptoms of patients who recently had a PCI. In this study, we aimed to assess the long-term potential benefits and safety of trimetazidine added to standard evidence-based medical treatment in patients who had a recent successful PCI.
METHODS


We did a randomised, double-blind, placebo-controlled, event-driven trial of trimetazidine added to standard background therapy in patients who had undergone successful PCI at 365 centres in 27 countries across Europe, South America, Asia, and north Africa. Eligible patients were aged 21-85 years and had had either elective PCI for stable angina or urgent PCI for unstable angina or non-ST segment elevation myocardial infarction less than 30 days before randomisation. Patients were randomly assigned by an interactive web response system to oral trimetazidine 35 mg modified-release twice daily or matching placebo. Participants, study investigators, and all study staff were masked to treatment allocation. The primary efficacy endpoint was a composite of cardiac death; hospital admission for a cardiac event; recurrence or persistence of angina requiring an addition, switch, or increase of the dose of at least one antianginal drug; or recurrence or persistence of angina requiring a coronary angiography. Efficacy analyses were done according to the intention-to-treat principle. Safety was assessed in all patients who had at least one dose of study drug. This study is registered with the EU Clinical Trials Register (EudraCT 2010-022134-89).
FINDINGS


From Sept 17, 2014, to June 15, 2016, 6007 patients were enrolled and randomly assigned to receive either trimetazidine (n=2998) or placebo (n=3009). After a median follow-up of 47·5 months (IQR 42·3-53·3), incidence of primary endpoint events was not significantly different between the trimetazidine group (700 [23·3%] patients) and the placebo group (714 [23·7%]; hazard ratio 0·98 [95% CI 0·88-1·09], p=0·73). When analysed individually, there were no significant differences in the incidence of the components of the primary endpoint between the treatment groups. Similar results were obtained when patients were categorised according to whether they had an elective or urgent PCI. 1219 (40·9%) of 2983 patients in the trimetazidine group and 1230 (41·1%) of 2990 patients in the placebo group had serious treatment-emergent adverse events. Frequencies of adverse events of interest were similar between the groups.
INTERPRETATION


Our results show that the routine use of oral trimetazidine 35 mg twice daily over several years in patients receiving optimal medical therapy, after successful PCI, does not influence the recurrence of angina or the outcome; these findings should be taken into account when considering the place of trimetazidine in clinical practice. However, the long-term prescription of this treatment does not appear to be associated with any statistically significant safety concerns in the population studied.
FUNDING


Servier.",2020,"When analysed individually, there were no significant differences in the incidence of the components of the primary endpoint between the treatment groups.","['patients who recently had a PCI', 'Eligible patients were aged 21-85 years and had had either elective PCI for stable angina or urgent PCI for unstable angina or non-ST segment elevation myocardial infarction less than 30 days before randomisation', 'From Sept 17, 2014, to June 15, 2016', 'patients who had a recent successful PCI', 'patients who had undergone successful PCI at 365 centres in 27 countries across Europe, South America, Asia, and north Africa', 'patients who had at least one dose of study drug', '6007 patients']","['Trimetazidine', 'trimetazidine 35 mg modified-release twice daily or matching placebo', 'percutaneous coronary intervention (ATPCI', 'percutaneous coronary intervention (PCI) and antianginal therapy', 'placebo', 'trimetazidine']","['Safety', 'serious treatment-emergent adverse events', 'incidence of primary endpoint events', 'Efficacy and safety', 'survival', 'composite of cardiac death; hospital admission for a cardiac event; recurrence or persistence of angina requiring an addition, switch, or increase of the dose of at least one antianginal drug; or recurrence or persistence of angina requiring a coronary angiography']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0001745', 'cui_str': 'Northern Africa'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}]","[{'cui': 'C0041037', 'cui_str': 'Trimetazidine'}, {'cui': 'C1383981', 'cui_str': 'Trimetazidine 35 MG'}, {'cui': 'C4544813', 'cui_str': 'Modified-release'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0585942', 'cui_str': 'Antianginal therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]",6007.0,0.677741,"When analysed individually, there were no significant differences in the incidence of the components of the primary endpoint between the treatment groups.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Ferrari', 'Affiliation': 'Cardiovascular Centre, University of Ferrara, Ospedale di Cona, Ferrara, Italy; Maria Cecilia Hospital, Cotignola, Ravenna, Italy. Electronic address: fri@unife.it.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Fox', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK; Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Jean Pascal', 'Initials': 'JP', 'LastName': 'Challeton', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Correges', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Tendera', 'Affiliation': 'Department of Cardiology and Structural Heart Disease, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Widimský', 'Affiliation': 'Cardiocenter, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Danchin', 'Affiliation': 'Department of Cardiology, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France; Université Paris-Descartes, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31790-6']
1548,32877722,Characteristics of contents in the upper gastrointestinal lumen after a standard high-calorie high-fat meal and implications for the in vitro drug product performance testing conditions.,"OBJECTIVES


To measure the pH, buffer capacity, lipid content, bile acid content, and viscosity in the upper gastrointestinal (GI) lumen after a standard high-calorie, high-fat meal as well as the osmolality, lipid content and bile acid content in the aqueous phase of the gastric contents and the micellar phase of contents of the upper small intestine. To evaluate the implications of these findings for the composition of biorelevant media employed in vitro oral drug product performance testing representing the upper GI conditions after ingestion of the standard meal.
METHODS


Eight healthy male adult volunteers participated in a two-phase, crossover study in which a homogenized standard meal was administered to the antrum via the gastric port of a naso-gastro-intestinal tube. A glass of tap water and single paracetamol and danazol doses were administered to the antrum of the stomach 30 min after the initiation of meal administration (Pentafragka et al., 2020). Samples were aspirated from the antrum and the upper small intestine over the next four hours. The pH and the buffer capacity of the samples were measured immediately upon aspiration, while viscosity, osmolality, and presence of solubilizing agents were measured after storage at -70 °C.
RESULTS


The composition of gastric contents over time fluctuated less after the homogenized standard meal than after liquid meals with similar composition. Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low. Mean viscosity values in the stomach at 100 s -1  were 80-800 times higher than in the fasted state for more than 3 h after the standard meal. In the upper small intestine, mean viscosity values at 100 s -1  were at least 100 times higher than in the fasted state for 4 h after the standard meal.
CONCLUSIONS


Based on data collected in this study, Level I and Level II biorelevant media simulating the intragastric conditions after ingestion of a standard meal could be simplified whereas FeSSIF-V2 composition was confirmed to be representative of the composition of contents in the upper small intestine. Representative values of viscosity in the stomach and the upper small intestine and Level II composition of the aqueous phase of gastric contents, after the standard meal, are proposed for first time.",2020,Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low.,['Eight healthy male adult volunteers'],"['homogenized standard meal', 'paracetamol and danazol']","['Mean viscosity values', 'mean viscosity values', 'viscosity, osmolality, and presence of solubilizing agents', 'pH, buffer capacity, lipid content, bile acid content, and viscosity in the upper gastrointestinal (GI) lumen']","[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0444664', 'cui_str': 'Standard meal'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}]",8.0,0.0385476,Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low.,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pentafragka', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vertzoni', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dressman', 'Affiliation': 'Goethe University, Frankfurt/Main, Germany.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Symillides', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Goumas', 'Affiliation': 'Department of Gastroenterology, Red Cross Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Reppas', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece. Electronic address: reppas@pharm.uoa.gr.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105535']
1549,32877791,"Parents as Teachers: Mothers' Roles in Sexual Abuse Prevention Education in Gorgan, Iran.","BACKGROUND


Parents play an important role in protecting their children from sexual abuse. Mothers, in particular, play key roles in the sexual socialization of their children and in educating their children about child sexual abuse (CSA).
OBJECTIVES


The purpose of this study was to determine whether preschool girls in Gorgan (a city in northern Iran) could learn personal safety skills when taught by their mothers.
PARTICIPANTS AND SETTING


Fifty-six participants (mother-daughter pairs) were recruited from patients visiting health centers. Mean age of girls was 6.34 years.
METHODS


Girls were pretested using Persian versions of the Personal Safety Questionnaire and 'What If' Situations Test, randomly assigned to either a mother-taught program or wait-list control, and post-tested. Mothers assigned to the education group participated in a two-hour workshop on preventing CSA and were given the Body Safety Training workbook to teach their daughters. Following the one-week training by their mothers, children in both groups were post-tested and follow-up tested one month later.
RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
CONCLUSION


Results suggest that mothers can effectively teach their young daughters personal safety skills. Difficulties female children have in recognizing appropriate-touch requests are discussed and compared to results in other developing countries. Advantages of home-based instruction for young children are described and suggestions for increasing parent participation are offered.",2020,"RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
","[""Mothers' Roles in Sexual Abuse Prevention Education in Gorgan, Iran"", 'Mean age of girls was 6.34 years', 'Difficulties female children', 'Fifty-six participants (mother-daughter pairs) were recruited from patients visiting health centers', 'young children', 'Parents as Teachers', 'Girls', 'preschool girls in Gorgan (a city in northern Iran']","['home-based instruction', 'mother-taught program or wait-list control, and post-tested']",['knowledge about sexual abuse and higher levels of personal safety skills'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C1633748', 'cui_str': 'Prevention education'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",56.0,0.0148705,"RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Khoori', 'Affiliation': 'Counselling and Reproductive Health Research Centre, Golestan University of Medical Sciences, Gorgan, Iran. Electronic address: elhamkhoori@yahoo.com.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Gholamfarkhani', 'Affiliation': 'Department of Obstetrics and Gynecology, Shohada Hospital of Quchan, Mashhad University of Medical Sciences, Quchan, Iran. Electronic address: somayeh.farkhani@gmail.com.'}, {'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Tatari', 'Affiliation': 'Counselling and Reproductive Health Research Centre, Golestan University of Medical Sciences, Gorgan, Iran. Electronic address: maisa.tatari@yahoo.com.'}, {'ForeName': 'Sandy K', 'Initials': 'SK', 'LastName': 'Wurtele', 'Affiliation': 'Department of Psychology, University of Colorado, Colorado Springs, USA. Electronic address: swurtele@uccs.edu.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104695']
1550,32881865,"Spatial spillover analysis of a cluster-randomized trial against dengue vectors in Trujillo, Venezuela.","BACKGROUND


The ability of cluster-randomized trials to capture mass or indirect effects is one reason for their increasing use to test interventions against vector-borne diseases such as malaria and dengue. For the same reason, however, the independence of clusters may be compromised if the distances between clusters is too small to ensure independence. In other words they may be subject to spillover effects.
METHODS


We distinguish two types of spatial spillover effect: between-cluster dependence in outcomes, or spillover dependence; and modification of the intervention effect according to distance to the intervention arm, or spillover indirect effect. We estimate these effects in trial of insecticide-treated materials against the dengue mosquito vector, Aedes aegypti, in Venezuela, the endpoint being the Breteau index. We use a novel random effects Poisson spatial regression model. Spillover dependence is incorporated via an orthogonalized intrinsic conditional autoregression (ICAR) model. Spillover indirect effects are incorporated via the number of locations within a certain radius, set at 200m, that are in the intervention arm.
RESULTS


From the model with ICAR spatial dependence, and the degree of surroundedness, the intervention effect is estimated as 0.74-favouring the intervention-with a 95% credible interval of 0.34 to 1.69. The point estimates are stronger with increasing surroundedness within intervention locations.
CONCLUSION


In this trial there is some evidence of a spillover indirect effect of the intervention, with the Breteau index tending to be lower in locations which are more surrounded by locations in the intervention arm.",2020,"We estimate these effects in trial of insecticide-treated materials against the dengue mosquito vector, Aedes aegypti, in Venezuela, the endpoint being the Breteau index.",[],[],[],[],[],[],,0.0575248,"We estimate these effects in trial of insecticide-treated materials against the dengue mosquito vector, Aedes aegypti, in Venezuela, the endpoint being the Breteau index.","[{'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': 'MRC Tropical Epidemiology Group, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Lenhart', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Anaya-Izquierdo', 'Affiliation': 'MRC Tropical Epidemiology Group, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008576']
1551,32881912,Feasibility of quantifying change in immune white cells in abdominal adipose tissue in response to an immune modulator in clinical obesity.,"BACKGROUND


Obesity is often associated with inflammation in adipose tissue (AT) with release of mediators of atherogenesis. We postulated that it would be feasible to collect sufficient abdominal AT to quantify changes in a broad array of adaptive and innate mononuclear white cells in obese non-diabetic adults in response to a dipeptidyl protease inhibitor (DPP4i), known to inhibit activation of immune white cells.
METHODS


Adults 18-55 years-of-age were screened for abdominal obesity and insulin resistance or impaired glucose tolerance but without known inflammatory conditions. Twenty-one eligible participants consented for study and were randomized 3:1 to receive sitagliptin (DPP4i) at 100mg or matching placebo daily for 28 days. Abdominal AT collected by percutaneous biopsy and peripheral blood mononuclear cell fractions were evaluated before and after treatment; plasma was stored for batch testing.
RESULTS


Highly sensitive C-reactive protein, a global marker of inflammation, was not elevated in the study population. Innate lymphoid cells (ILC) type 3 (ILC-3) in abdominal AT decreased with active treatment compared with placebo (p = 0.04). Other immune white cells in AT and peripheral blood mononuclear cell (PBMC) fractions did not change with treatment compared to placebo (p>0.05); although ILC-2 declined in PBMCs (p = 0.007) in the sitagliptin treatment group. Two circulating biomarkers of atherogenesis, interferon-inducible protein-10 (IP-10) and sCD40L declined in plasma (p = 0.02 and p = 0.07, respectively) in the active treatment group, providing indirect validation of a net reduction in inflammation.
CONCLUSIONS


In this pilot study, two cell types of the innate lymphoid system, ILC-3 in AT and ILC-2 PBMCs declined during treatment and as did circulating biomarkers of atherogenesis. Changes in other immune cells were not demonstrable. The study showed that sufficient abdominal AT could be obtained to quantify white cells of both innate and adaptive immunity and to demonstrate changes during therapy with an immune inhibitor.
TRIAL REGISTRATION


ClinicalTrials.gov identifier (NCT number): NCT02576.",2020,Other immune white cells in AT and peripheral blood mononuclear cell (PBMC) fractions did not change with treatment compared to placebo (p>0.05); although ILC-2 declined in PBMCs (p = 0.007) in the sitagliptin treatment group.,"['Twenty-one eligible participants consented for study', 'Adults 18-55 years-of-age were screened for abdominal obesity and insulin resistance or impaired glucose tolerance but without known inflammatory conditions', 'obese non-diabetic adults']","['placebo', 'sitagliptin (DPP4i) at 100mg or matching placebo']","['Innate lymphoid cells (ILC) type 3 (ILC-3', 'ILC-2 declined in PBMCs', 'ILC-3 in AT and ILC-2 PBMCs', 'peripheral blood mononuclear cell (PBMC) fractions', 'atherogenesis, interferon-inducible protein-10 (IP-10) and sCD40L declined in plasma']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0086574', 'cui_str': 'Lymphoid Cells'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C1563937', 'cui_str': 'Atherogenesis'}, {'cui': 'C0056978', 'cui_str': 'CXCL10 Chemokine'}, {'cui': 'C1533698', 'cui_str': 'Nitric Oxide Synthase, Type II'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",21.0,0.139292,Other immune white cells in AT and peripheral blood mononuclear cell (PBMC) fractions did not change with treatment compared to placebo (p>0.05); although ILC-2 declined in PBMCs (p = 0.007) in the sitagliptin treatment group.,"[{'ForeName': 'Fred R', 'Initials': 'FR', 'LastName': 'Sattler', 'Affiliation': 'Department of Medicine, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mert', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Ishwarya', 'Initials': 'I', 'LastName': 'Sankaranarayanan', 'Affiliation': 'Department of Molecular Microbiology and Immunology, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Lauriane', 'Initials': 'L', 'LastName': 'Galle-Treger', 'Affiliation': 'Department of Molecular Microbiology and Immunology, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Medicine, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Lilit', 'Initials': 'L', 'LastName': 'Baronikian', 'Affiliation': 'Department of Medicine, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Kyuwan', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Ostrow School of Dentistry, Division of Physical Therapy and Biokinesiology, University of Southern California, Los Angeles, California, United States of America.'}, {'ForeName': 'Pedram Shafiei', 'Initials': 'PS', 'LastName': 'Jahani', 'Affiliation': 'Department of Molecular Microbiology and Immunology, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': 'Department of Medicine, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dieli-Conwright', 'Affiliation': 'Ostrow School of Dentistry, Division of Physical Therapy and Biokinesiology, University of Southern California, Los Angeles, California, United States of America.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Akbari', 'Affiliation': 'Department of Molecular Microbiology and Immunology, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0237496']
1552,32881921,Progressive active mobilization with dose control and training load in critically ill patients (PROMOB): Protocol for a randomized controlled trial.,"The dose of progressive active mobilization is still uncertain. The purpose of this study is to identify if the addition of a protocol of progressive active mobilization with dose and training load control to usual care is effective in reducing the length of stay in intensive care unit (ICU) and the improvement of the functioning, incidence of ICU-acquired weakness (ICUAW), mechanical ventilation duration and mortality rate in patients hospitalized in ICU. It is Double-blind randomised clinical trial. The setting for this trial will be medical and surgical ICU of a university hospital. The study participants will be 118 patients aged> 18 years admitted to ICU for less than 72 hours. Participants will be randomized to either an experimental or control group. The experimental group will undertake addition of a protocol of progressive active mobilization with dose and training load control to usual care, while the control group will undertake only usual care. The primary outcome will be length of ICU stay. The secondary outcomes will be Cross-sectional area and muscle thickness of the rectus femoris and biceps brachii, Change in muscle strength from the baseline, Functional Status, incidence of ICUAW, Days with mechanical ventilation and Mortality. All statistical analyses will be conducted following intention-to-treat principles. It has a detailed description of the dose of exercise, was designed with the strictest methodological criteria. These characteristics allow to investigate with greater certainty the results progressive active mobilization in critical patients, allowing replication and future combinations in meta-analyzes.",2020,"The secondary outcomes will be Cross-sectional area and muscle thickness of the rectus femoris and biceps brachii, Change in muscle strength from the baseline, Functional Status, incidence of ICUAW, Days with mechanical ventilation and Mortality.","['118 patients aged> 18 years admitted to ICU for less than 72 hours', 'critically ill patients (PROMOB', 'patients hospitalized in ICU']","['progressive active mobilization with dose and training load control to usual care, while the control group will undertake only usual care']","['length of stay in intensive care unit (ICU', 'Cross-sectional area and muscle thickness of the rectus femoris and biceps brachii, Change in muscle strength from the baseline, Functional Status, incidence of ICUAW, Days with mechanical ventilation and Mortality', 'functioning, incidence of ICU-acquired weakness (ICUAW), mechanical ventilation duration and mortality rate', 'length of ICU stay']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4087120', 'cui_str': 'Intensive care unit acquired weakness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",118.0,0.1781,"The secondary outcomes will be Cross-sectional area and muscle thickness of the rectus femoris and biceps brachii, Change in muscle strength from the baseline, Functional Status, incidence of ICUAW, Days with mechanical ventilation and Mortality.","[{'ForeName': 'Rodrigo Santos de', 'Initials': 'RS', 'LastName': 'Queiroz', 'Affiliation': 'Program in Medicine and Health of the Faculty of Medicine, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Micheli Bernardone', 'Initials': 'MB', 'LastName': 'Saquetto', 'Affiliation': 'Department of Physical Therapy, Institute of Health Sciences, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Bruno Prata', 'Initials': 'BP', 'LastName': 'Martinez', 'Affiliation': 'Department of Physical Therapy, Institute of Health Sciences, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Bianca Bigogno Reis', 'Initials': 'BBR', 'LastName': 'Cazeta', 'Affiliation': 'Program in Medicine and Health of the Faculty of Medicine, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Hodgson', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.'}, {'ForeName': 'Mansueto', 'Initials': 'M', 'LastName': 'Gomes-Neto', 'Affiliation': 'Department of Physical Therapy, Institute of Health Sciences, Federal University of Bahia, Salvador, Brazil.'}]",PloS one,['10.1371/journal.pone.0238352']
1553,32883807,Prenatal and Pediatric Primary Care-Based Child Obesity Prevention Program: A Randomized Trial.,"OBJECTIVES


To determine impact of a primary care-based child obesity prevention intervention beginning during pregnancy on early childhood weight outcomes in low-income Hispanic families.
METHODS


A randomized controlled trial comparing mother-infant pairs receiving either standard care or the Starting Early Program providing prenatal and postpartum nutrition counseling and nutrition parenting support groups targeting key obesity-related feeding practices in low-income groups. Primary outcomes were reduction in weight-for-age  z -scores (WFAzs) from clinical anthropometric measures, obesity prevalence (weight for age ≥95th percentile), and excess weight gain (WFAz trajectory) from birth to age 3 years. Secondary outcomes included dose effects.
RESULTS


Pregnant women ( n  = 566) were enrolled in the third trimester; 533 randomized to intervention ( n  = 266) or control ( n  = 267). Also, 358 children had their weight measured at age 2 years; 285 children had weight measured at age 3 years. Intervention infants had lower mean WFAz at 18 months (0.49 vs 0.73,  P  = .04) and 2 years (0.56 vs 0.81,  P  = .03) but not at 3 years (0.63 vs 0.59,  P  = .76). No group differences in obesity prevalence were found. When generalized estimating equations were used, significant average treatment effects were detected between 10-26 months (B = -0.19,  P  = .047), although not through age 3 years. In within group dose analyses at 3 years, obesity rates (26.4%, 22.5%, 8.0%,  P  = .02) decreased as attendance increased with low, medium, and high attendance.
CONCLUSIONS


Mean WFAz and growth trajectories were lower for the intervention group through age 2 years, but there were no group differences at age 3. Further study is needed to enhance sustainability of effects beyond age 2.",2020,"Intervention infants had lower mean WFAz at 18 months (0.49 vs 0.73,  P  = .04) and 2 years (0.56 vs 0.81,  P  = .03) but not at 3 years (0.63 vs 0.59,  P  = .76).","['358 children had their weight measured at age 2 years; 285 children had weight measured at age 3 years', 'Pregnant women ( n  = 566) were enrolled in the third trimester; 533 randomized to intervention ( n  = 266) or control ( n  = 267', 'low-income Hispanic families', 'mother-infant pairs receiving either']","['primary care-based child obesity prevention intervention', 'standard care or the Starting Early Program providing prenatal and postpartum nutrition counseling and nutrition parenting support groups targeting key obesity-related feeding practices in low-income groups', 'Prenatal and Pediatric Primary Care-Based Child Obesity Prevention Program']","['lower mean WFAz', 'attendance increased with low, medium, and high attendance', 'Mean WFAz and growth trajectories', 'dose effects', 'obesity prevalence', 'reduction in weight-for-age  z -scores (WFAzs) from clinical anthropometric measures, obesity prevalence (weight for age ≥95th percentile), and excess weight gain (WFAz trajectory', 'obesity rates']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043101', 'cui_str': 'Weights and Measures'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",566.0,0.0827146,"Intervention infants had lower mean WFAz at 18 months (0.49 vs 0.73,  P  = .04) and 2 years (0.56 vs 0.81,  P  = .03) but not at 3 years (0.63 vs 0.59,  P  = .76).","[{'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Messito', 'Affiliation': 'Divisions of General Pediatrics and mary.messito@nyumc.org.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Mendelsohn', 'Affiliation': 'Developmental and Behavioral Pediatrics, Department of Pediatrics, NYU Grossman School of Medicine and.'}, {'ForeName': 'Michelle W', 'Initials': 'MW', 'LastName': 'Katzow', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Scott', 'Affiliation': 'Department of Applied Statistics, Social Science, and Humanities, Steinhardt School of Culture, Education, and Human Development, New York University, New York, New York; and.'}, {'ForeName': 'Sarvenaz', 'Initials': 'S', 'LastName': 'Vandyousefi', 'Affiliation': 'Divisions of General Pediatrics and.'}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Gross', 'Affiliation': 'Divisions of General Pediatrics and.'}]",Pediatrics,['10.1542/peds.2020-0709']
1554,32887379,"Effects of Capsinoid Intake on Brown Adipose Tissue Vascular Density and Resting Energy Expenditure in Healthy, Middle-Aged Adults: A Randomized, Double-Blind, Placebo-Controlled Study.","Capsinoids are some of the most promising ingredients to increase energy expenditure (EE) due to brown adipose tissue (BAT) activation. However, there is limited information regarding the effect of prolonged capsinoid ingestion (CI) on BAT activity and resting EE (REE) in healthy, middle-aged, normal to overweight subjects (Sub healthy ) with distinct BAT characteristics. We examined the changes in BAT density (BAT-d), using near-infrared time-resolved spectroscopy, and REE/kg induced by daily CI. Forty Sub healthy  [age, 43.8 (mean) years; BMI, 25.4 kg/m 2 ] received either capsinoid (9 mg/day) or a placebo daily for 6 weeks in a double-blind design. Total hemoglobin concentration in the supraclavicular region ([total-Hb] sup ), an indicator of BAT-d, and REE/kg were measured. The changes in post-intervention [total-Hb] sup  were greater in the capsinoid group (CA-G) than in the placebo group (PL-G) [5.8 µM (+12.4%) versus 1.0 µM (+2.1%);  p  = 0.017]. There was a significant relationship between BAT-d and REE/kg; however, post-supplementation REE/kg was not significantly different between the two groups ( p  = 0.228). In the overweight subgroup, changes in REE/kg were greater in the CA-G than in the PL-G [0.6 cal/kg/min (+4.3%) versus -0.3 cal/kg/min (-2.1%);  p  = 0.021]. CI enhanced [total-Hb] sup , a reflection of BAT-d, showing a good correlation with REE in Sub healthy .",2020,"In the overweight subgroup, changes in REE/kg were greater in the CA-G than in the PL-G [0.6 cal/kg/min (+4.3%) versus -0.3 cal/kg/min (-2.1%);  p  = 0.021].","['Forty Sub healthy  [age, 43.8 (mean) years', 'healthy, middle-aged, normal to overweight subjects (Sub healthy ) with distinct BAT characteristics', 'Healthy, Middle-Aged Adults']","['prolonged capsinoid ingestion (CI', 'Capsinoid Intake', 'placebo', 'capsinoid', 'Placebo']","['energy expenditure (EE', 'BAT activity and resting EE (REE', 'Total hemoglobin concentration', 'CI enhanced [total-Hb', 'Brown Adipose Tissue Vascular Density and Resting Energy Expenditure']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",,0.334693,"In the overweight subgroup, changes in REE/kg were greater in the CA-G than in the PL-G [0.6 cal/kg/min (+4.3%) versus -0.3 cal/kg/min (-2.1%);  p  = 0.021].","[{'ForeName': 'Sayuri', 'Initials': 'S', 'LastName': 'Fuse', 'Affiliation': 'Department of Sports Medicine for Health Promotion, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402, Japan.'}, {'ForeName': 'Tasuki', 'Initials': 'T', 'LastName': 'Endo', 'Affiliation': 'Department of Sports Medicine for Health Promotion, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402, Japan.'}, {'ForeName': 'Riki', 'Initials': 'R', 'LastName': 'Tanaka', 'Affiliation': 'Department of Sports Medicine for Health Promotion, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402, Japan.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Kuroiwa', 'Affiliation': 'Department of Sports Medicine for Health Promotion, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ando', 'Affiliation': 'Department of Sport Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo 115-0056, Japan.'}, {'ForeName': 'Ayami', 'Initials': 'A', 'LastName': 'Kume', 'Affiliation': 'Department of Sports Medicine for Health Promotion, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Ajinomoto Co., Inc., Institute of Food Sciences and Technologies, 1-1 Suzuki-cho, Kawasaki-ku, Kawasaki City, Kanagawa 210-8681, Japan.'}, {'ForeName': 'Kanna', 'Initials': 'K', 'LastName': 'Kuribayashi', 'Affiliation': 'Ajinomoto Co., Inc., Institute of Food Sciences and Technologies, 1-1 Suzuki-cho, Kawasaki-ku, Kawasaki City, Kanagawa 210-8681, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Somekawa', 'Affiliation': 'Ajinomoto Co., Inc., Institute of Food Sciences and Technologies, 1-1 Suzuki-cho, Kawasaki-ku, Kawasaki City, Kanagawa 210-8681, Japan.'}, {'ForeName': 'Masamichi', 'Initials': 'M', 'LastName': 'Takeshita', 'Affiliation': 'Ajinomoto Co., Inc., Research Institute for Bioscience Products & Fine Chemicals, 1-1 Suzuki-cho, Kawasaki-ku, Kawasaki City, Kanagawa 210-8681, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Hashimoto', 'Affiliation': 'Ajinomoto Co., Inc., Direct Marketing Department, 15-1, Kyobashi 1-chome, Chuo-ku, Tokyo 104-8315, Japan.'}, {'ForeName': 'Ryotaro', 'Initials': 'R', 'LastName': 'Kime', 'Affiliation': 'Department of Sports Medicine for Health Promotion, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Kurosawa', 'Affiliation': 'Department of Sports Medicine for Health Promotion, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Hamaoka', 'Affiliation': 'Department of Sports Medicine for Health Promotion, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402, Japan.'}]",Nutrients,['10.3390/nu12092676']
1555,32894793,A multicenter prospective study for overactive bladder patient treatment satisfaction with mirabegron after being unsatisfied with antimuscarinic therapy (FAVOR study).,"AIM


We investigated the satisfaction and efficacy of mirabegron in patients with overactive bladder (OAB) symptoms who were unsatisfied with previous antimuscarinic treatment.
METHODS


This was a 12-week, open-label study of adults with OAB who had been treated with antimuscarinics within 2 years of screening and expressed dissatisfaction over poor efficacy or adverse events of antimuscarinics. All enrolled patients have received mirabegron 50 mg once daily for 12 weeks. The primary outcome was the percentage of patients reporting treatment satisfaction questions (TSQ) at week 12 (""very satisfied"" or ""somewhat satisfied""). Patients completed voiding diaries, Overactive Bladder Questionnaire short form (OAB-q-SF), Overactive Bladder Symptom Score (OABSS), and the global response assessment (GRA) at baseline, Week 4, and Week 12. At 12-weeks, patients were assessed for willingness to continue treatment.
RESULTS


The response rate of treatment satisfaction at 12 weeks was 69.3% (275/397) (95% confidence interval 64.7-73.8). Significant improvements from baseline to weeks 4 and 12 were observed in the frequency, urgency due to urinary incontinence, and urgency episodes per 24 h (all p < .0001). Both OAB-q-SF and OABSS were significantly improved compared to baseline. At 4 and 12 weeks, 27.5% and 41.8% of patients, respectively, responded to the GRA as being moderately or markedly improved. At 12 weeks, 80.8% of patients were willing to continue mirabegron.
CONCLUSIONS


Mirabegron improved the rates of treatment satisfaction and symptoms in patients with OAB who were unsatisfied with prior antimuscarinic treatment.",2020,"Significant improvements from baseline to weeks 4 and 12 were observed in the frequency, urgency due to urinary incontinence, and urgency episodes per 24 h (all p < .0001).","['patients with overactive bladder (OAB) symptoms who were unsatisfied with previous antimuscarinic treatment', 'adults with OAB who had been treated with antimuscarinics within 2 years of screening and expressed dissatisfaction over poor efficacy or adverse events of antimuscarinics', 'patients with OAB who were unsatisfied with prior antimuscarinic treatment', 'overactive bladder patient treatment satisfaction with mirabegron after being unsatisfied with antimuscarinic therapy\xa0(FAVOR study']",['mirabegron'],"['rates of treatment satisfaction and symptoms', 'response rate of treatment satisfaction', 'OAB-q-SF and OABSS', 'voiding diaries, Overactive Bladder Questionnaire short form (OAB-q-SF), Overactive Bladder Symptom Score (OABSS), and the global response assessment (GRA', 'frequency, urgency due to urinary incontinence, and urgency episodes', 'percentage of patients reporting treatment satisfaction questions (TSQ', 'satisfaction and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C2983812', 'cui_str': 'mirabegron'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0680329,"Significant improvements from baseline to weeks 4 and 12 were observed in the frequency, urgency due to urinary incontinence, and urgency episodes per 24 h (all p < .0001).","[{'ForeName': 'Kwang Jin', 'Initials': 'KJ', 'LastName': 'Ko', 'Affiliation': 'Department of Urology,\xa0Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Myung-Soo', 'Initials': 'MS', 'LastName': 'Choo', 'Affiliation': 'Department of Urology,\xa0Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young-Seop', 'Initials': 'YS', 'LastName': 'Chang', 'Affiliation': 'Department of Urology, Konyang University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Joon Chul', 'Initials': 'JC', 'LastName': 'Kim', 'Affiliation': 'Department of Urology I College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Kyu-Sung', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Department of Urology,\xa0Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",Neurourology and urodynamics,['10.1002/nau.24505']
1556,32898930,Accuracy of contralateral Villalta score to assess for pre-existing chronic venous insufficiency in patients with unilateral deep vein thrombosis.,"BACKGROUND


International guidelines recommend using the Villalta score (VS) to diagnose the postthrombotic syndrome (PTS). However, a high proportion of PTS detected with VS could just reflect the presence of preexisting primary venous insufficiency (PVI). Furthermore, it is unclear whether the contralateral VS (cl-VS) can be used to assess for preexisting PVI.
OBJECTIVES


To estimate whether cl-VS can be used to assess for preexisting PVI, and to assess the proportion of PTS that could be attributable to preexisting PVI.
METHODS


Subanalysis of the SOX multicenter randomized trial focusing on patients with a first unilateral proximal deep vein thrombosis (DVT) followed for up to 2 years. PVI was defined as a baseline cl-VS > 4, and PTS as VS > 4 in the leg ipsilateral to DVT starting 6 months after DVT.
RESULTS


Among 680 patients, mean cl-VS remained stable over time: 1.23 (standard deviation [SD] ±2.49) at baseline and 1.17 (±2.20), 1.59 (±2.81), 1.54 (±2.50), 1.65 (±2.82), and 1.55 (±2.63) at the 1-, 6-, 12-, 18-, and 24-month visits, respectively. Baseline cl-VS and ipsilateral VS measured during follow-up were mildly correlated (Pearson correlation = 0.13-0.25). This association disappeared after subtracting the cl-VS measured at the same visit from the ipsilateral VS. Overall, 48.8% of patients developed PTS of whom 12.8% had baseline cl-VS > 4.
CONCLUSION


In our study of patients with a first unilateral proximal DVT, the proportion of patients with PTS who had a cl-VS > 4 is modest. However, cl-VS appears to be stable over time. Its assessment could constitute a simple way of documenting preexisting PVI and help to classify patients as having PTS.",2020,"Overall, 48.8% of patients developed PTS of whom 12.8% had baseline cl-VS>4.
CONCLUSION


","['patients with unilateral deep vein thrombosis', '680 patients', 'patients with a first unilateral proximal DVT followed for up to 2 years']",[],"['Baseline cl-VS and ipsilateral VS', 'PVI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0042485', 'cui_str': 'Peripheral venous insufficiency'}]",680.0,0.0679659,"Overall, 48.8% of patients developed PTS of whom 12.8% had baseline cl-VS>4.
CONCLUSION


","[{'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Galanaud', 'Affiliation': 'Department of Medicine, Sunnybrook Health Sciences Centre and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Ducruet', 'Affiliation': 'URCA-CHU Sainte Justine, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Kahn', 'Affiliation': 'Department of Medicine and Lady Davis Institute, Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.15091']
1557,32899107,The Effect of Resistance Exercise Intensity on Acute Hyperglycemia in Young Adult Males.,"The purpose of this study was to examine the effect of resistance exercise (RE) intensity on acute hyperglycemia, in young adult males. Thirteen males (age 23.43 ± 2.18 years, height 175.16 ± 10.44 cm, weight 77.02 ± 8.91 kg, body fat 20 ± 0.03%) participated in three randomized testing sessions, each separated by 96 h. The three testing conditions were: control (CON; induction of hyperglycemia with no-exercise), high (HI; induction of hyperglycemia followed by high-intensity RE: 5 × 4, 90% 1-repetition maximum (1-RM)), and moderate (MO; induction of hyperglycemia followed by low-intensity RE: 3 × 14, 65% 1-RM). In all three testing conditions, participants orally ingested a D100 (100 g/10 oz) glucose beverage at a dosage of 2 g glucose/kg body weight and capillary blood was obtained for plasma glucose and insulin analysis at 0 (fasting), 30, 60, 90 and 120 min, following glucose ingestion. At 30-min post-ingestion in the HI and MO conditions, participants began the respective RE protocols. Acute hyperglycemia was achieved throughout all three 2-h testing conditions; mean 2-h plasma glucose levels during CON (7.1 ± 1.3 mmol∙L -1 ), MO (7.5 ± 0.6 mmol∙L -1 ) and HI (8.2 ± 1.9 mmol∙L -1 ) were all significantly ( p  < 0.05) greater than mean fasting plasma glucose (5.6 ± 0.46 mmol∙L -1 ). Plasma glucose and insulin did not differ ( p  < 0.05) between treatment conditions at any times points over the 120 min, however, 2-h glucose area under the curve in the HI condition was significantly greater ( p  < 0.05) than CON and MO. In conclusion, this study indicates that hyperglycemia, induced prior to RE, may be exacerbated by high-intensity RE.",2020,"Plasma glucose and insulin did not differ ( p  < 0.05) between treatment conditions at any times points over the 120 min, however, 2-h glucose area under the curve in the HI condition was significantly greater ( p  < 0.05) than CON and MO.","['Young Adult Males', 'Thirteen males (age 23.43 ± 2.18 years, height 175.16 ± 10.44 cm, weight 77.02 ± 8.91 kg, body fat 20 ± 0.03%) participated in three randomized testing sessions, each separated by 96 h', 'young adult males']","['Resistance Exercise Intensity', 'resistance exercise (RE) intensity', 'control (CON; induction of hyperglycemia with no-exercise), high (HI; induction of hyperglycemia followed by high-intensity RE']","['2-h glucose area under the curve in the HI condition', 'Acute Hyperglycemia', 'Plasma glucose and insulin', 'Acute hyperglycemia', 'mean fasting plasma glucose', 'plasma glucose levels']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0443299', 'cui_str': 'Separate'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0342301', 'cui_str': 'Acute hyperglycemia'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0280633,"Plasma glucose and insulin did not differ ( p  < 0.05) between treatment conditions at any times points over the 120 min, however, 2-h glucose area under the curve in the HI condition was significantly greater ( p  < 0.05) than CON and MO.","[{'ForeName': 'Evan E', 'Initials': 'EE', 'LastName': 'Schick', 'Affiliation': 'Physiology of Exercise and Sport Laboratory, California State University, Long Beach, CA 90840, USA.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Segura', 'Affiliation': 'Physiology of Exercise and Sport Laboratory, California State University, Long Beach, CA 90840, USA.'}, {'ForeName': 'Shayán', 'Initials': 'S', 'LastName': 'Emamjomeh', 'Affiliation': 'Physiology of Exercise and Sport Laboratory, California State University, Long Beach, CA 90840, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Cotter', 'Affiliation': 'Physiology of Exercise and Sport Laboratory, California State University, Long Beach, CA 90840, USA.'}]","Sports (Basel, Switzerland)",['10.3390/sports8090121']
1558,32899673,Effects of Maternal Fish Oil and/or 5-Methyl-Tetrahydrofolate Supplementation during Pregnancy on Offspring Brain Resting-State at 10 Years Old: A Follow-Up Study from the NUHEAL Randomized Controlled Trial.,"Recent studies have shown that maternal supplementation with folate and long-chain polyunsaturated fatty acids (LC-PUFAs) during pregnancy may affect children's brain development. We aimed at examining the potential long-term effect of maternal supplementation with fish oil (FO) and/or 5-methyl-tetrahydrofolate (5-MTHF) on the brain functionality of offspring at the age of 9.5-10 years. The current study was conducted as a follow-up of the Spanish participants belonging to the Nutraceuticals for a Healthier Life (NUHEAL) project; 57 children were divided into groups according to mother's supplementation and assessed through functional magnetic resonance imaging (fMRI) scanning and neurodevelopment testing. Independent component analysis and double regression methods were implemented to investigate plausible associations. Children born to mothers supplemented with FO (FO and FO + 5-MTHF groups,  n  = 33) showed weaker functional connectivity in the default mode (DM) (angular gyrus), the sensorimotor (SM) (motor and somatosensory cortices) and the fronto-parietal (FP) (angular gyrus) networks compared to the No-FO group (placebo and 5-MTHF groups,  n  = 24) (P FWE  < 0.05). Furthermore, no differences were found regarding the neuropsychological tests, except for a trend of better results in an object recall (memory) test. Considering the No-FO group, the aforementioned networks were associated negatively with attention and speed-processing functions. Mother's FO supplementation during pregnancy seems to be able to shape resting-state network functioning in their children at school age and appears to produce long-term effects on children´s cognitive processing.",2020,"Furthermore, no differences were found regarding the neuropsychological tests, except for a trend of better results in an object recall (memory) test.","['offspring at the age of 9.5-10 years', 'Spanish participants belonging to the Nutraceuticals for a Healthier Life (NUHEAL) project; 57 children', 'Offspring Brain Resting-State at 10 Years Old']","['maternal supplementation with fish oil (FO) and/or 5-methyl-tetrahydrofolate (5-MTHF', 'FO (FO and FO + 5-MTHF', ""mother's supplementation and assessed through functional magnetic resonance imaging (fMRI) scanning and neurodevelopment testing"", 'Maternal Fish Oil and/or 5-Methyl-Tetrahydrofolate Supplementation', 'maternal supplementation with folate and long-chain polyunsaturated fatty acids (LC-PUFAs']","['object recall (memory) test', 'functional connectivity', 'attention and speed-processing functions', 'sensorimotor (SM) (motor and somatosensory cortices) and the fronto-parietal (FP) (angular gyrus) networks']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0039669', 'cui_str': 'Tetrahydrofolates'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]","[{'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0152305', 'cui_str': 'Structure of angular gyrus'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",57.0,0.0369052,"Furthermore, no differences were found regarding the neuropsychological tests, except for a trend of better results in an object recall (memory) test.","[{'ForeName': 'Hatim', 'Initials': 'H', 'LastName': 'Azaryah', 'Affiliation': 'Department of Paediatrics, School of Medicine, University of Granada, Avda. Investigación 11, 18016 Granada, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Verdejo-Román', 'Affiliation': 'Mind, Brain and Behaviour International Research Centre (CIMCYC), University of Granada, 18011 Granada, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Martin-Pérez', 'Affiliation': 'Mind, Brain and Behaviour International Research Centre (CIMCYC), University of Granada, 18011 Granada, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'García-Santos', 'Affiliation': 'Department of Paediatrics, School of Medicine, University of Granada, Avda. Investigación 11, 18016 Granada, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Martínez-Zaldívar', 'Affiliation': 'Department of Paediatrics, School of Medicine, University of Granada, Avda. Investigación 11, 18016 Granada, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Torres-Espínola', 'Affiliation': 'Department of Paediatrics, School of Medicine, University of Granada, Avda. Investigación 11, 18016 Granada, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Campos', 'Affiliation': 'Department of Paediatrics, School of Medicine, University of Granada, Avda. Investigación 11, 18016 Granada, Spain.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Koletzko', 'Affiliation': ""Ludwig-Maximiliams-Universität München, Dr. von Hauner Children's Hospital, University of Munich Hospitals, 80337 Munich, Germany.""}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Pérez-García', 'Affiliation': 'Mind, Brain and Behaviour International Research Centre (CIMCYC), University of Granada, 18011 Granada, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Catena', 'Affiliation': 'Mind, Brain and Behaviour International Research Centre (CIMCYC), University of Granada, 18011 Granada, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Campoy', 'Affiliation': 'Department of Paediatrics, School of Medicine, University of Granada, Avda. Investigación 11, 18016 Granada, Spain.'}]",Nutrients,['10.3390/nu12092701']
1559,32901330,Safety Profile and Adverse Events of Special Interest for Fruquintinib in Chinese Patients with Previously Treated Metastatic Colorectal Cancer: Analysis of the Phase 3 FRESCO Trial.,"INTRODUCTION


In FRESCO (Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients) trial, fruquintinib demonstrated a statistically significant and clinically meaningful overall survival benefit in Chinese patients with metastatic colorectal cancer (mCRC). However, its safety profile, including adverse events of special interest (AESIs) and treatment-emergent adverse events (TEAEs) by age, sex, and body mass index (BMI), is not well known. The present analysis evaluated the safety profile and AESIs for fruquintinib in the FRESCO trial.
METHODS


In FRESCO, eligible Chinese patients were randomized (2:1) to receive fruquintinib (5 mg once daily for 3 weeks, followed by 1 week off in 28-day cycles) or placebo plus best supportive care. Treatment-related AESIs and time to first occurrence of AESIs were summarized. Treatment-related TEAEs by age, sex, and BMI were also summarized.
RESULTS


A total of 266 patients (95.7%) in the fruquintinib group and 97 (70.8%) in the placebo group had at least one treatment-related TEAE; the mean relative dose intensity was 92% and 98%, respectively. In the fruquintinib group, the most common (in > 40% of patients) treatment-related AESIs were hypertension (55.4%), palmar-plantar erythrodysesthesia syndrome [known as hand-foot skin reaction (HFSR)] (49.3%), and proteinuria (42.1%). The most common treatment-related grade ≥ 3 AESIs (≥ 3% of patients) were hypertension (21.2%), HFSR (10.8%), and proteinuria (3.2%); the median time to onset of these events was 10, 21, and 20 days, respectively. Subgroup analysis by age, sex, and BMI revealed that the frequencies of treatment-related TEAEs were similar across all subgroups, and were consistent with the overall safety profile of fruquintinib.
CONCLUSIONS


The most common treatment-related grade ≥ 3 AEs were hypertension, HFSR, and proteinuria. The treatment-related TEAE profile of fruquintinib in Chinese patents with mCRC was comparable among different subgroups and consistent with that reported in the overall population.
TRIAL REGISTRATION


Clinical Trials identifier NCT02314819.",2020,"The treatment-related TEAE profile of fruquintinib in Chinese patents with mCRC was comparable among different subgroups and consistent with that reported in the overall population.
","['eligible Chinese patients', 'Chinese Patients with Previously Treated Metastatic Colorectal Cancer', 'Chinese patients with metastatic colorectal cancer (mCRC']","['placebo', 'placebo plus best supportive care']","['adverse events of special interest (AESIs) and treatment-emergent adverse events (TEAEs) by age, sex, and body mass index (BMI', 'palmar-plantar erythrodysesthesia syndrome [known as hand-foot skin reaction (HFSR', 'HFSR', 'safety profile and AESIs', 'hypertension']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",266.0,0.204187,"The treatment-related TEAE profile of fruquintinib in Chinese patents with mCRC was comparable among different subgroups and consistent with that reported in the overall population.
","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Tongji University East Hospital, Shanghai, China.'}, {'ForeName': 'Weijian', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Oncology, Shanghai Medical College, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Medical Oncology, The Sixth Hospital Affiliated to Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Oncology, Nantong Cancer Hospital, Nantong, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, The Second Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Ruihua', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Department of Medical Oncology, Sir Run Run Shaw Hospital, Hangzhou, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Department of Medical Oncology, Jiangsu Provincial Hospital, Nanjing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, The Second Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Oncology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, China.'}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Fudan University Zhongshan Hospital, Shanghai, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': ""Department of Medical Oncology, Guangdong Provincial People's Hospital, Guangzhou, China.""}, {'ForeName': 'Changping', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': ""Department of Medical Oncology, The First People's Hospital of Changzhou, Changzhou, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Medical Oncology, Jilin Province Cancer Hospital, Changchun, China.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, The Fifth Medical Center of Chinese, PLA General Hospital, Beijing, China.'}, {'ForeName': 'Donghui', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Department of Medical Oncology, Shanghai Jiao Tong University Affiliated First People's Hospital, Shanghai, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Sanyuan', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Oncology, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Oncology, The Affiliated Hospital of Medical College Qingdao University, Qingdao, China.'}, {'ForeName': 'Peiguo', 'Initials': 'P', 'LastName': 'Cao', 'Affiliation': 'Department of Medical Oncology, Xiangya Hospital of Central South University, The Third Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Haihui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Medical Oncology, Liuzhou Worker's Hospital, Liuzhou, China.""}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Beijing University ShenZhen Hospital, Beijing University, Shenzhen, China.'}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, The Affiliated Hospital of Xuzhou Medical College, Xuzhou Medical College, Xuzhou, China.'}, {'ForeName': 'Songhua', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Hutchison MediPharma Limited, Shanghai, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Hutchison MediPharma Limited, Shanghai, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Lilly China, Drug Development and Medical Affairs Center, Shanghai, China.'}, {'ForeName': 'Rubing', 'Initials': 'R', 'LastName': 'Han', 'Affiliation': 'Lilly China, Drug Development and Medical Affairs Center, Shanghai, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Lilly China, Drug Development and Medical Affairs Center, Shanghai, China.'}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'Cancer Center of Jinling Hospital, Nanjing, China. shukui_qin123@hotmail.com.'}]",Advances in therapy,['10.1007/s12325-020-01477-w']
1560,32901950,Shorter RSPV cryoapplications result in less phrenic nerve injury and similar 1-year freedom from atrial fibrillation.,"BACKGROUND


In the 123-study, we prospectively assessed, in a randomized fashion, the minimal cryoballoon application time necessary to achieve pulmonary vein (PV) isolation (PVI) in patients with paroxysmal atrial fibrillation (AF) with the aim to reduce complications by shortening the application duration. The first results of this study demonstrated that shortened cryoballoon applications (<2 minutes) resulted in less phrenic nerve injury (PNI) without compromising acute isolation efficacy for the right PVs. We now report the 1-year follow-up results regarding safety and efficacy of shorter cryoballoon applications.
METHODS


A total of 222 patients with AF were randomized to two applications of 1 min ""short,"" 2 min ""medium,"" or 3 min ""long"" duration, 74 per group. Recurrence of AF and PV reconduction at 1-year follow-up were assessed.
RESULTS


The overall 1-year freedom from AF was 79% and did not differ significantly between the short, medium, and long application groups (77%, 74%, and 85% for short, medium, and long application groups, respectively; P = 0.07). In 30 patients, a redo PVI procedure was performed. For all four PVs, there was no significant difference in reconduction between the three groups. Reconduction was most common in the left superior PV (57%). The right superior PV (RSPV) showed significantly less reconduction (17%) compared to the other PVs.
CONCLUSIONS


Shortening cryoballoon applications of the RSPV to <2 minutes results in less PNI, while acute success and 1-year freedom from AF are not compromised. Therefore, shorter cryoballoon applications (especially) in the RSPV could be used to reduce PNI.",2020,"The overall 1-year freedom from AF was 79% and did not differ significantly between the short, medium and long application groups (77, 74 and 85% for short, medium and long application groups, respectively; P = 0.07).","['222 patients with AF', 'patients with paroxysmal atrial fibrillation (AF']",['pulmonary vein (PV) isolation (PVI'],"['overall 1-year freedom from AF', 'reconduction', 'Recurrence of AF and PV reconduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}]","[{'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}]",222.0,0.0304896,"The overall 1-year freedom from AF was 79% and did not differ significantly between the short, medium and long application groups (77, 74 and 85% for short, medium and long application groups, respectively; P = 0.07).","[{'ForeName': 'Marleen M D', 'Initials': 'MMD', 'LastName': 'Molenaar', 'Affiliation': 'Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Hesselink', 'Affiliation': 'Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Rachel M A', 'Initials': 'RMA', 'LastName': 'Ter Bekke', 'Affiliation': 'Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Marcoen F', 'Initials': 'MF', 'LastName': 'Scholten', 'Affiliation': 'Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Manusama', 'Affiliation': 'Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Pison', 'Affiliation': 'Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Brusse-Keizer', 'Affiliation': 'Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Kraaier', 'Affiliation': 'Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Ten Haken', 'Affiliation': 'Universiteit Twente, Enschede, The Netherlands.'}, {'ForeName': 'Jan G', 'Initials': 'JG', 'LastName': 'Grandjean', 'Affiliation': 'Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Carl C', 'Initials': 'CC', 'LastName': 'Timmermans', 'Affiliation': 'Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Jurren M', 'Initials': 'JM', 'LastName': 'van Opstal', 'Affiliation': 'Medisch Spectrum Twente, Enschede, The Netherlands.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.14062']
1561,32901972,Effects of listening to music in digestive endoscopy: A prospective intervention study led by nursing.,"AIMS


To explore whether music can reduce anxiety and pain in patients who underwent diagnostic endoscopic examinations in conscious and deep sedation and to assess degree of satisfaction and willingness to repeat the procedure.
DESIGN


Prospective study led by nursing.
METHODS


Between March 2019-June 2019, consecutive outpatients undergoing endoscopic examinations were simple matched into four groups: Group 1: conscious sedation with music; Group 2: conscious sedation without music; Group 3: deep sedation with music and Group 4: deep sedation without music. Ten minutes before the procedure, two trainee nurses applied music. State-Trait Anxiety Inventory was used to evaluate anxiety.
RESULTS


Before and at the end of the procedure, patients who listened to music had a lower level anxiety than those who did not listen and, also, reported lower pain intensity during procedure. Only within Group 1 median anxiety, measured after the procedure, is lower than that measured before. In the bivariate logistic regression model, pain and listening to music were independent factors for satisfaction and willingness to repeat procedure.
CONCLUSION


music in digestive endoscopy reduce pain and anxiety in conscious sedation, thus could be used to reduce anxiety in support to conscious sedation leading to lower usage of deep sedation and consequently reduction of costs and adverse events.
IMPACT


Anxiety in digestive endoscopy limits patients' satisfaction. Music in digestive endoscopy as a specific nursing intervention could reduce anxiety of patients. This nursing intervention study confirms positive effect of music in digestive endoscopy. As part of nursing management, the addition of music to daily care practice in digestive endoscopy may reduce anxiety and increase the patient's degree of satisfaction. Use of music could limit deep sedation use in digestive endoscopy with consequent reduction of risks for patients, execution times, and costs of procedures.",2020,"Before and at the end of the procedure, patients who listened to music had a lower level anxiety than those who did not listen and, also, reported lower pain intensity during procedure.","[""digestive endoscopy limits patients' satisfaction"", 'digestive endoscopy', 'patients who underwent diagnostic endoscopic examinations in conscious and deep sedation', 'Between March 2019-June 2019, consecutive outpatients undergoing']","['listening to music', 'music in digestive endoscopy', 'endoscopic examinations', 'conscious sedation with music; Group 2: conscious sedation without music; Group 3: deep sedation with music and Group 4: deep sedation without music']","['pain and anxiety', 'level anxiety', 'pain intensity', 'anxiety and pain', 'median anxiety']","[{'cui': 'C0079278', 'cui_str': 'Gastrointestinal tract endoscopy'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C1956064', 'cui_str': 'Sedation, Deep'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0079278', 'cui_str': 'Gastrointestinal tract endoscopy'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C1956064', 'cui_str': 'Sedation, Deep'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.072793,"Before and at the end of the procedure, patients who listened to music had a lower level anxiety than those who did not listen and, also, reported lower pain intensity during procedure.","[{'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Spagnuolo', 'Affiliation': ""Department of Clinical and Experimental Medicine, University 'Magna Graecia', Catanzaro, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Corea', 'Affiliation': ""Department of Clinical and Experimental Medicine, University 'Magna Graecia', Catanzaro, Italy.""}, {'ForeName': 'Mariantonietta', 'Initials': 'M', 'LastName': 'Blumetti', 'Affiliation': ""School of Nursing, University 'Magna Graecia', Catanzaro, Italy.""}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Giovinazzo', 'Affiliation': ""School of Nursing, University 'Magna Graecia', Catanzaro, Italy.""}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Serafino', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Pagliuso', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Pagnotta', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Curto', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cosco', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Cosco', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Rosellina Margherita', 'Initials': 'RM', 'LastName': 'Mancina', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Garieri', 'Affiliation': 'European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Papaleo', 'Affiliation': 'Maggiore Hospital, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Grande', 'Affiliation': 'Department of Abdominal Surgery, S. Rita Clinic, Vercelli, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Barilaro', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Garofalo', 'Affiliation': ""Department of Surgical and Medical Sciences, University 'Magna Graecia', Catanzaro, Italy.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bruni', 'Affiliation': ""Department of Surgical and Medical Sciences, University 'Magna Graecia', Catanzaro, Italy.""}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Doldo', 'Affiliation': ""Department of Clinical and Experimental Medicine, University 'Magna Graecia', Catanzaro, Italy.""}]",Journal of advanced nursing,['10.1111/jan.14516']
1562,32901984,Internet-based support program on parenting outcomes for Chinese primiparous women: Study protocol for a randomized controlled trial.,"AIM


To evaluate the effects of internet-based support program for primiparous women in terms of improving the levels of maternal self-efficacy, social support, and satisfaction; and reducing their postpartum depression symptoms.
DESIGN


A single-blinded, multicentre, randomized, controlled, parallel-group pre-test and repeated post-test design.
METHODS


Based on the self-efficacy theory and the social exchange theory, the internet-based support program has five modules: (a) learning forum of parenting knowledge and skills; (b) communication forum; (c) ask-the-expert forum; (d) baby home forum; and (e) reminder forum. Primiparous women will be recruited in the obstetric wards of two university-affiliated hospitals in China. The participants (N = 258) will be randomly allocated to the intervention group that receive routine care and access to the internet-based support program and the control group that receive routine care during the 3 months postpartum. Maternal self-efficacy, social support, and postpartum depression symptoms will be measured at baseline, immediately after the intervention (post-test 1) and 3 months after the intervention (post-test 2). The study was funded in January 2018 and was ethically approved in May 2020.
DISCUSSION


If the internet-based support program has positive outcomes, it will contribute to the scientific and practical knowledge of nursing interventions to support primiparous women on parenting; and could become the routine health care for health professionals to enhance parenting ability and mental well-being of new mothers.
IMPACT


As the first RCT study on parenting outcomes using a rigorous research design and a theoretical framework in China, this research will contribute to evidence on the effectiveness of using internet platform to support women after childbirth. The results could help to advance research about the use of internet-based intervention methods to improve women's maternal self-efficacy, social support, satisfaction, and to alleviate depression symptoms. Chinese Clinical Trial Registry: ChiCTR2000033154.",2020,"The results could help to advance research about the use of internet-based intervention methods to improve women's maternal self-efficacy, social support, satisfaction, and to alleviate depression symptoms.","['Chinese primiparous women', 'Primiparous women will be recruited in the obstetric wards of two university-affiliated hospitals in China', 'participants (N\xa0=\xa0258', 'primiparous women', 'primiparous women on parenting']","['social exchange theory, the internet-based support program', 'internet-based support program', 'Internet-based support program', 'intervention group that receive routine care and access to the internet-based support program and the control group that receive routine care']","['maternal self-efficacy, social support, and satisfaction', 'Maternal self-efficacy, social support, and postpartum depression symptoms']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",258.0,0.062753,"The results could help to advance research about the use of internet-based intervention methods to improve women's maternal self-efficacy, social support, satisfaction, and to alleviate depression symptoms.","[{'ForeName': 'Xujuan', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Qiyu', 'Initials': 'Q', 'LastName': 'Fang', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Xilin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Ziwen', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}]",Journal of advanced nursing,['10.1111/jan.14517']
1563,32898141,A pilot feasibility randomised controlled trial of two behaviour change interventions compared to usual care to reduce substance misuse in looked after children and care leavers aged 12-20 years: The SOLID study.,"BACKGROUND


Young people in state care, often due to abuse or neglect, have a four-fold increased risk of drug and alcohol use compared to their peers.
AIM


The SOLID study aimed to investigate the feasibility of a definitive randomised controlled trial, comparing two behaviour change interventions to reduce risky substance use (illicit drugs and alcohol), and improve mental health, in young people in care.
METHODS


We recruited young people in care aged 12-20 years, self-reporting substance use within the previous 12 months and residing in 1 of 6 participating local authority sites in the North East of England. Participants were randomised to either i. Motivational Enhancement Therapy (MET), ii. Social Behaviour and Network Therapy (SBNT) or iii. Control (usual care). All interventions were delivered by trained drug and alcohol workers. Follow-up data were collected 12 months post recruitment. Feasibility for trial progression was compared to pre-specified stop: go criteria (recruitment of 60% of eligible participants, 80% of participants attending 60% of offered sessions and retention of 70% of participants at 12 month follow up).
RESULTS


Of 1450 eligible participants, 860 (59%) were screened for drug and alcohol use by social workers, 211 (24.5%) met inclusion criteria for the trial and 112 young people (7.7%) consented and were randomised. Sixty of these 112 participants (54%) completed 12-month follow-up questionnaires. Only 15 out of the 76 (20%) participants allocated to an intervention arm attended any of the offered MET or SBNT sessions.
CONCLUSION


By reference to pre-specified stop: go criteria it is not feasible to conduct a definitive trial for SOLID in its current format. Despite co-designing procedures with staff and young people in care, the screening, referral and treatment pathway did not work here. Future work may require dedicated clinically embedded research resource to evaluate effectiveness of new interventions in services.",2020,"Despite co-designing procedures with staff and young people in care, the screening, referral and treatment pathway did not work here.","['1450 eligible participants, 860 (59%) were screened for drug and alcohol use by social workers, 211 (24.5%) met inclusion criteria for the trial and 112 young people (7.7%) consented and were randomised', 'looked after children and care leavers aged 12-20 years', 'young people in care aged 12-20 years, self-reporting substance use within the previous 12 months and residing in 1 of 6 participating local authority sites in the North East of England', 'young people in care', 'Sixty of these 112 participants (54%) completed 12-month follow-up questionnaires']","['Social Behaviour and Network Therapy (SBNT', 'behaviour change interventions', 'risky substance use (illicit drugs and alcohol', 'usual care', 'Motivational Enhancement Therapy (MET']",['mental health'],"[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4749226', 'cui_str': 'Aging out of youth care system'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0086190', 'cui_str': 'Drugs, Illegal'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",1450.0,0.0965647,"Despite co-designing procedures with staff and young people in care, the screening, referral and treatment pathway did not work here.","[{'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Alderson', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kaner', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Howel', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Fouweather', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McGovern', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Copello', 'Affiliation': 'School of Psychology, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McArdle', 'Affiliation': 'Child and Adolescent, Mental Health Services, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle, United Kingdom.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Smart', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Raghu', 'Initials': 'R', 'LastName': 'Lingam', 'Affiliation': ""Population Child Health Research Group, School of Women and Children's Health, University New South Wales, Randwick, Australia.""}]",PloS one,['10.1371/journal.pone.0238286']
1564,32914852,General and Eating Disorder Psychopathology in Relation to Short- and Long-Term Weight Change in Treatment-Seeking Children: A Latent Profile Analysis.,"BACKGROUND


Concurrent general psychopathology (GP) and eating disorder psychopathology (EDP) are commonly reported among youth with overweight/obesity and may impact weight change.
PURPOSE


We identified patterns of GP and EDP in children with overweight/obesity and examined the impact on weight change following family-based behavioral obesity treatment (FBT) and maintenance interventions.
METHODS


Children (N = 172) participated in 4 month FBT and subsequent 8 month weight maintenance interventions. GP and EDP were assessed prior to FBT (baseline). Child percentage overweight was assessed at baseline, post-FBT (4 months), and post-maintenance (12 months). Latent profile analysis identified patterns of baseline GP and EDP. Linear mixed-effects models examined if profiles predicted 4- and 12-month change in percentage overweight and if there were two-way and three-way interactions among these variables, adjusting for relevant covariates.
RESULTS


Results indicated a three-profile structure: lower GP and EDP (LOWER); subclinically elevated GP and EDP without loss of control (LOC; HIGHER); and subclinically elevated GP and EDP with LOC (HIGHER + LOC). Across profiles, children on average achieved clinically meaningful weight loss (i.e., ≥9 unit change in percentage overweight) from baseline to 4 month FBT and sustained these improvements at 12 month maintenance. There was no evidence that latent profiles were related to percentage overweight change from baseline to FBT (p > .05) or baseline to maintenance (p > .05). There was no evidence for two-way or three-way interactions (p > .05).
CONCLUSION


Concurrent GP and EDP do not portend differential short- or long-term weight change following FBT and maintenance. Future research is warranted on the durability of weight change among youth with GP and EDP.
TRIAL REGISTRATION


NCT00759746.",2020,There was no evidence that latent profiles were related to percentage overweight change from baseline to FBT (p > .05) or baseline to maintenance (p > .05).,"['Treatment-Seeking Children', 'youth with GP and EDP', 'children with overweight/obesity and examined the impact on weight change following family-based behavioral obesity treatment (FBT) and maintenance interventions', 'Children (N = 172) participated in 4 month FBT and subsequent 8 month weight maintenance interventions']",['GP and EDP'],"['meaningful weight loss', 'Child percentage overweight', 'GP and EDP (LOWER); subclinically elevated GP and EDP without loss of control (LOC; HIGHER); and subclinically elevated GP and EDP with LOC (HIGHER + LOC', 'GP and EDP']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0424666', 'cui_str': 'Percentage overweight'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",172.0,0.0511677,There was no evidence that latent profiles were related to percentage overweight change from baseline to FBT (p > .05) or baseline to maintenance (p > .05).,"[{'ForeName': 'Anne Claire', 'Initials': 'AC', 'LastName': 'Grammer', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Best', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Fowler', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Katherine N', 'Initials': 'KN', 'LastName': 'Balantekin', 'Affiliation': 'Department of Exercise and Nutrition Sciences, School of Public Health and Health Professions, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Stein', 'Affiliation': 'Department of Internal Medicine, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Rachel P Kolko', 'Initials': 'RPK', 'LastName': 'Conlon', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Saelens', 'Affiliation': ""Department of Pediatrics, University of Washington and Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'R Robinson', 'Initials': 'RR', 'LastName': 'Welch', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Perri', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Wilfley', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa076']
1565,32915421,Continuous Lumbar Sympathetic Blockade Enhances the Effect of Lumbar Sympatholysis on Refractory Diabetic Neuropathy: A Randomized Controlled Trial.,"INTRODUCTION


There are a number of options for the symptomatic treatment of peripheral neuropathy, but the overall treatment outcomes remain unsatisfactory.
METHODS


A total of 60 patients with refractory diabetic neuropathy were randomly assigned to two groups. Patients in Group A were treated with computed tomography (CT)-guided sympathetic neurolysis with alcohol, and patients in Group B were treated with a combined therapy of CT-guided catheterization to achieve continuous lumbar block for 4 weeks followed by neurolysis with alcohol administered via the catheter. The outcomes of these two treatment strategies were then analyzed in terms of pain relief, blood flow in the lower limb microcirculation, plasma levels of inflammatory mediators, and complications.
RESULTS


The visual analog scale (VAS) pain scores of all patients after treatment decreased significantly at the different evaluation time points compared with pre-treatment values, with the intergroup analysis revealing that the VAS scores were lower in Group B patients than in Group A patients at all post-treatment time points. Skin temperature, capillary filling time, and blood oxygen saturation level were significantly improved in all patients at the 1- and 7-day post-treatment assessment compared to pre-treatment values, but patients in Group B showed a greater improvement. The plasma levels of inflammatory mediators were lower in all patients at the 7-day post-treatment assessment compared to pre-treatment values, with those of patients in Group B being statistically significantly lower than those of patients in Group A.
CONCLUSION


Combined treatment with continuous lumbar sympathetic block followed by neurolysis with alcohol provided more benefit in all assessed outcomes than sympathetic alcohol neurolysis alone. The results show that the procedures were associated with satisfactory safety outcomes and sustained analgesic effects, thereby providing clinical evidence supporting the use of this novel treatment for patients with painful diabetic neuropathy.",2020,"The plasma levels of inflammatory mediators were lower in all patients at the 7-day post-treatment assessment compared to pre-treatment values, with those of patients in Group B being statistically significantly lower than those of patients in Group A.
CONCLUSION


Combined treatment with continuous lumbar sympathetic block followed by neurolysis with alcohol provided more benefit in all assessed outcomes than sympathetic alcohol neurolysis alone.","['Refractory Diabetic Neuropathy', '60 patients with refractory diabetic neuropathy', 'patients with painful diabetic neuropathy']","['computed tomography (CT)-guided sympathetic neurolysis with alcohol', 'CT-guided catheterization to achieve continuous lumbar block for 4 weeks followed by neurolysis with alcohol administered via the catheter', 'Lumbar Sympatholysis']","['VAS scores', 'plasma levels of inflammatory mediators', 'Skin temperature, capillary filling time, and blood oxygen saturation level', 'pain relief, blood flow in the lower limb microcirculation, plasma levels of inflammatory mediators, and complications', 'satisfactory safety outcomes and sustained analgesic effects', 'visual analog scale (VAS) pain scores']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751074', 'cui_str': 'Neuralgia, Diabetic'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0196878', 'cui_str': 'Neurolysis'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C2609163', 'cui_str': 'Sympatholysis'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0425716', 'cui_str': 'Capillary filling'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",60.0,0.0298423,"The plasma levels of inflammatory mediators were lower in all patients at the 7-day post-treatment assessment compared to pre-treatment values, with those of patients in Group B being statistically significantly lower than those of patients in Group A.
CONCLUSION


Combined treatment with continuous lumbar sympathetic block followed by neurolysis with alcohol provided more benefit in all assessed outcomes than sympathetic alcohol neurolysis alone.","[{'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Center of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Mingwei', 'Initials': 'M', 'LastName': 'He', 'Affiliation': 'Center of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Jinlei', 'Initials': 'J', 'LastName': 'Pang', 'Affiliation': 'Center of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Xiangfei', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Center of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Yansong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Center of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Center of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China. majun7689@163.com.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00918-7']
1566,32915506,The development and testing of a nurse-led smartphone-based self-management programme for diabetes patients with poor glycaemic control.,"AIMS


To describe a systematic process for the development of a nurse-led smartphone-based self-management programme for type 2 diabetes patients with poor glycaemic control in Singapore.
METHODS


A three-step process involving the application of a theoretical framework, evidence from literature, content validity, and pilot tests were conducted for the content and technical development of the programme. Content experts and lay patients evaluated the appropriateness, relevance, and comprehensibility of the newly developed Care4Diabetes application. A pilot randomized controlled trial was conducted with 40 patients recruited in Singapore. Twenty patients each were randomly allocated to the control and intervention groups. The study outcomes were collected at baseline and at 3 months thereafter.
RESULTS


The nurse-led smartphone-based self-management programme was developed with integration of the Care4Diabetes application and the web-portal system. The pilot results indicated that the effects of this smartphone-based programme on patient's health-related outcomes were comparable with those of the currently available nurse-led diabetes service.
CONCLUSION


The smartphone-based self-management intervention was deemed effective, yet full-scale randomized controlled trials are still ongoing and the results of these may provide strong evidence of the effectiveness of such an approach in improving patient care.
IMPACT


The uniqueness of this study lies in the integrated system used, which offers a clinical platform for diabetes nurses to provide personalized coaching and care to patients remotely, while monitoring patients' progress closely. By adopting such an approach, it would free up more time for nurses to cater to patients who are more critically in need of their direct attention.",2020,"The pilot results indicated that the effects of this smartphone-based programme on patient's health-related outcomes were comparable with those of the currently available nurse-led diabetes service.
","['diabetes patients with poor glycaemic control', '40 patients recruited in Singapore', 'Twenty patients each', 'type 2 diabetes patients with poor glycaemic control in Singapore']","['smartphone-based self-management intervention', 'smartphone-based programme', 'nurse-led smartphone-based self-management programme']",[],"[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",[],40.0,0.035263,"The pilot results indicated that the effects of this smartphone-based programme on patient's health-related outcomes were comparable with those of the currently available nurse-led diabetes service.
","[{'ForeName': 'Wenru', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Michelle Tze Min', 'Initials': 'MTM', 'LastName': 'Cheng', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Foon Leng', 'Initials': 'FL', 'LastName': 'Leong', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Antoinette Wei Ling', 'Initials': 'AWL', 'LastName': 'Goh', 'Affiliation': 'National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Suan Tee', 'Initials': 'ST', 'LastName': 'Lim', 'Affiliation': 'National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}]",Journal of advanced nursing,['10.1111/jan.14519']
1567,32885780,The Effects of Differing Invitation Models on the Uptake of Immunological Fecal Occult Blood Testing.,"BACKGROUND


Participation rates in colorectal cancer screening in Germany are low. We therefore investigated the effectiveness of different invitation models for immunological stool blood tests (fecal immunological tests, FITs).
METHODS


A randomized controlled trial in 50- to 54-year-old clients of the health insurance provider AOK Baden-Wuerttemberg. A total of 17 532 insured persons were randomized to receive: (A) an invitation letter including a FIT (n = 5850); (B) an invitation letter including an option to request a FIT (n = 5844); or (C) an invitation letter only (n = 5838; control group, routine practice). Reminder letters were sent to half the members of groups A and B, selected at random, after 4 weeks. The primary endpoint was the use of a FIT within 1 year of the date of the invitation letter. IRRID: RR2-10.2196/16413. Registration: DRKS00011858.
RESULTS


The invitation letter with a FIT enclosed (A) increased usage from 10% to 29.7% compared with the control group (+19.7% points, p < 0.0001; men: +19.4%, women: +18.8%). The invitation letter with a FIT request option (B) increased usage from 10% to 27.7% (+17.7% points, p < 0.0001; men: +17.7%, women: +17.4%). Reminders increased usage in group A by 7.5% points and in group B by 8.5% points. Participation among women was higher than among men in all groups. The FIT positivity rate was 6.9%. A subsequent colonoscopy was reported for 64.3% of FIT-positive participants, and advanced neoplasia was found in 21.3% of these cases.
CONCLUSION


Letters of invitation that include a FIT and those that offer low-threshold access to a FIT achieve strong, comparable increases in the usage of FIT in the context of colorectal cancer screening.",2020,Reminders increased usage in group A by 7.5% points and in group B by 8.5% points.,"['50- to 54-year-old clients of the health insurance provider AOK Baden-Wuerttemberg', 'A total of 17 532 insured persons']",['invitation letter including a FIT (n = 5850); (B) an invitation letter including an option to request a FIT'],"['FIT positivity rate', 'advanced neoplasia', 'use of a FIT within 1 year of the date of the invitation letter']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]","[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]",17532.0,0.0690682,Reminders increased usage in group A by 7.5% points and in group B by 8.5% points.,"[{'ForeName': 'Laura Fiona', 'Initials': 'LF', 'LastName': 'Gruner', 'Affiliation': 'Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Heidelberg; Medical Faculty Heidelberg, University of Heidelberg; Gastroenterologische Schwerpunktpraxis, Dornstadt; AOK Baden-Wuerttemberg, Stuttgart; Division of Preventive Oncology, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg; German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), Heidelberg.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hoffmeister', 'Affiliation': ''}, {'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Ludwig', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Meny', 'Affiliation': ''}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Brenner', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2020.0423']
1568,32350058,Practice advisory update summary: Patent foramen ovale and secondary stroke prevention: Report of the Guideline Subcommittee of the American Academy of Neurology.,"OBJECTIVE


To update the 2016 American Academy of Neurology (AAN) practice advisory for patients with stroke and patent foramen ovale (PFO).
METHODS


The guideline panel followed the AAN 2017 guideline development process to systematically review studies published through December 2017 and formulate recommendations.
MAJOR RECOMMENDATIONS


In patients being considered for PFO closure, clinicians should ensure that an appropriately thorough evaluation has been performed to rule out alternative mechanisms of stroke (level B). In patients with a higher risk alternative mechanism of stroke identified, clinicians should not routinely recommend PFO closure (level B). Clinicians should counsel patients that having a PFO is common; that it occurs in about 1 in 4 adults in the general population; that it is difficult to determine with certainty whether their PFO caused their stroke; and that PFO closure probably reduces recurrent stroke risk in select patients (level B). In patients younger than 60 years with a PFO and embolic-appearing infarct and no other mechanism of stroke identified, clinicians may recommend closure following a discussion of potential benefits (absolute recurrent stroke risk reduction of 3.4% at 5 years) and risks (periprocedural complication rate of 3.9% and increased absolute rate of non-periprocedural atrial fibrillation of 0.33% per year) (level C). In patients who opt to receive medical therapy alone without PFO closure, clinicians may recommend an antiplatelet medication such as aspirin or anticoagulation (level C).",2020,"In patients younger than 60 years with a PFO and embolic-appearing infarct and no other mechanism of stroke identified, clinicians may recommend closure following a discussion of potential benefits (absolute recurrent stroke risk reduction of 3.4% at 5 years) and risks (periprocedural complication rate of 3.9% and increased absolute rate of non-periprocedural atrial fibrillation of 0.33% per year) (level C).","['2016 American Academy of Neurology', 'patients with stroke and patent foramen ovale (PFO']",['aspirin or anticoagulation (level C'],['absolute rate of non-periprocedural atrial fibrillation'],"[{'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0016522', 'cui_str': 'Patent foramen ovale'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",,0.0256749,"In patients younger than 60 years with a PFO and embolic-appearing infarct and no other mechanism of stroke identified, clinicians may recommend closure following a discussion of potential benefits (absolute recurrent stroke risk reduction of 3.4% at 5 years) and risks (periprocedural complication rate of 3.9% and increased absolute rate of non-periprocedural atrial fibrillation of 0.33% per year) (level C).","[{'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Messé', 'Affiliation': 'From the Department of Neurology (S.R.M., S.E.K.), University of Pennsylvania School of Medicine, Philadelphia; Department of Neurology (G.S.G., L.R.), University of Kansas Medical Center, MO; Institute for Clinical Research and Health Policy Studies (D.M.K.), Tufts University School of Medicine, Boston, MA; Cardiology Section (J.R.K.), San Francisco Veterans Affairs Health Care System, and Departments of Medicine, and Epidemiology and Biostatistics (J.R.K.), University of California San Francisco; Division of Cardiology (S.H.), Columbia University Medical Center, New York; Department of Medicine (Cardiology) (J.D.C.), University of Colorado School of Medicine, Aurora; Department of Neurology (K.I.), New York University; and Department of Neurology (N.S.), Kaiser Permanente, Los Angeles, CA.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Gronseth', 'Affiliation': 'From the Department of Neurology (S.R.M., S.E.K.), University of Pennsylvania School of Medicine, Philadelphia; Department of Neurology (G.S.G., L.R.), University of Kansas Medical Center, MO; Institute for Clinical Research and Health Policy Studies (D.M.K.), Tufts University School of Medicine, Boston, MA; Cardiology Section (J.R.K.), San Francisco Veterans Affairs Health Care System, and Departments of Medicine, and Epidemiology and Biostatistics (J.R.K.), University of California San Francisco; Division of Cardiology (S.H.), Columbia University Medical Center, New York; Department of Medicine (Cardiology) (J.D.C.), University of Colorado School of Medicine, Aurora; Department of Neurology (K.I.), New York University; and Department of Neurology (N.S.), Kaiser Permanente, Los Angeles, CA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kent', 'Affiliation': 'From the Department of Neurology (S.R.M., S.E.K.), University of Pennsylvania School of Medicine, Philadelphia; Department of Neurology (G.S.G., L.R.), University of Kansas Medical Center, MO; Institute for Clinical Research and Health Policy Studies (D.M.K.), Tufts University School of Medicine, Boston, MA; Cardiology Section (J.R.K.), San Francisco Veterans Affairs Health Care System, and Departments of Medicine, and Epidemiology and Biostatistics (J.R.K.), University of California San Francisco; Division of Cardiology (S.H.), Columbia University Medical Center, New York; Department of Medicine (Cardiology) (J.D.C.), University of Colorado School of Medicine, Aurora; Department of Neurology (K.I.), New York University; and Department of Neurology (N.S.), Kaiser Permanente, Los Angeles, CA.'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Kizer', 'Affiliation': 'From the Department of Neurology (S.R.M., S.E.K.), University of Pennsylvania School of Medicine, Philadelphia; Department of Neurology (G.S.G., L.R.), University of Kansas Medical Center, MO; Institute for Clinical Research and Health Policy Studies (D.M.K.), Tufts University School of Medicine, Boston, MA; Cardiology Section (J.R.K.), San Francisco Veterans Affairs Health Care System, and Departments of Medicine, and Epidemiology and Biostatistics (J.R.K.), University of California San Francisco; Division of Cardiology (S.H.), Columbia University Medical Center, New York; Department of Medicine (Cardiology) (J.D.C.), University of Colorado School of Medicine, Aurora; Department of Neurology (K.I.), New York University; and Department of Neurology (N.S.), Kaiser Permanente, Los Angeles, CA.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Homma', 'Affiliation': 'From the Department of Neurology (S.R.M., S.E.K.), University of Pennsylvania School of Medicine, Philadelphia; Department of Neurology (G.S.G., L.R.), University of Kansas Medical Center, MO; Institute for Clinical Research and Health Policy Studies (D.M.K.), Tufts University School of Medicine, Boston, MA; Cardiology Section (J.R.K.), San Francisco Veterans Affairs Health Care System, and Departments of Medicine, and Epidemiology and Biostatistics (J.R.K.), University of California San Francisco; Division of Cardiology (S.H.), Columbia University Medical Center, New York; Department of Medicine (Cardiology) (J.D.C.), University of Colorado School of Medicine, Aurora; Department of Neurology (K.I.), New York University; and Department of Neurology (N.S.), Kaiser Permanente, Los Angeles, CA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Rosterman', 'Affiliation': 'From the Department of Neurology (S.R.M., S.E.K.), University of Pennsylvania School of Medicine, Philadelphia; Department of Neurology (G.S.G., L.R.), University of Kansas Medical Center, MO; Institute for Clinical Research and Health Policy Studies (D.M.K.), Tufts University School of Medicine, Boston, MA; Cardiology Section (J.R.K.), San Francisco Veterans Affairs Health Care System, and Departments of Medicine, and Epidemiology and Biostatistics (J.R.K.), University of California San Francisco; Division of Cardiology (S.H.), Columbia University Medical Center, New York; Department of Medicine (Cardiology) (J.D.C.), University of Colorado School of Medicine, Aurora; Department of Neurology (K.I.), New York University; and Department of Neurology (N.S.), Kaiser Permanente, Los Angeles, CA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Carroll', 'Affiliation': 'From the Department of Neurology (S.R.M., S.E.K.), University of Pennsylvania School of Medicine, Philadelphia; Department of Neurology (G.S.G., L.R.), University of Kansas Medical Center, MO; Institute for Clinical Research and Health Policy Studies (D.M.K.), Tufts University School of Medicine, Boston, MA; Cardiology Section (J.R.K.), San Francisco Veterans Affairs Health Care System, and Departments of Medicine, and Epidemiology and Biostatistics (J.R.K.), University of California San Francisco; Division of Cardiology (S.H.), Columbia University Medical Center, New York; Department of Medicine (Cardiology) (J.D.C.), University of Colorado School of Medicine, Aurora; Department of Neurology (K.I.), New York University; and Department of Neurology (N.S.), Kaiser Permanente, Los Angeles, CA.'}, {'ForeName': 'Koto', 'Initials': 'K', 'LastName': 'Ishida', 'Affiliation': 'From the Department of Neurology (S.R.M., S.E.K.), University of Pennsylvania School of Medicine, Philadelphia; Department of Neurology (G.S.G., L.R.), University of Kansas Medical Center, MO; Institute for Clinical Research and Health Policy Studies (D.M.K.), Tufts University School of Medicine, Boston, MA; Cardiology Section (J.R.K.), San Francisco Veterans Affairs Health Care System, and Departments of Medicine, and Epidemiology and Biostatistics (J.R.K.), University of California San Francisco; Division of Cardiology (S.H.), Columbia University Medical Center, New York; Department of Medicine (Cardiology) (J.D.C.), University of Colorado School of Medicine, Aurora; Department of Neurology (K.I.), New York University; and Department of Neurology (N.S.), Kaiser Permanente, Los Angeles, CA.'}, {'ForeName': 'Navdeep', 'Initials': 'N', 'LastName': 'Sangha', 'Affiliation': 'From the Department of Neurology (S.R.M., S.E.K.), University of Pennsylvania School of Medicine, Philadelphia; Department of Neurology (G.S.G., L.R.), University of Kansas Medical Center, MO; Institute for Clinical Research and Health Policy Studies (D.M.K.), Tufts University School of Medicine, Boston, MA; Cardiology Section (J.R.K.), San Francisco Veterans Affairs Health Care System, and Departments of Medicine, and Epidemiology and Biostatistics (J.R.K.), University of California San Francisco; Division of Cardiology (S.H.), Columbia University Medical Center, New York; Department of Medicine (Cardiology) (J.D.C.), University of Colorado School of Medicine, Aurora; Department of Neurology (K.I.), New York University; and Department of Neurology (N.S.), Kaiser Permanente, Los Angeles, CA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Kasner', 'Affiliation': 'From the Department of Neurology (S.R.M., S.E.K.), University of Pennsylvania School of Medicine, Philadelphia; Department of Neurology (G.S.G., L.R.), University of Kansas Medical Center, MO; Institute for Clinical Research and Health Policy Studies (D.M.K.), Tufts University School of Medicine, Boston, MA; Cardiology Section (J.R.K.), San Francisco Veterans Affairs Health Care System, and Departments of Medicine, and Epidemiology and Biostatistics (J.R.K.), University of California San Francisco; Division of Cardiology (S.H.), Columbia University Medical Center, New York; Department of Medicine (Cardiology) (J.D.C.), University of Colorado School of Medicine, Aurora; Department of Neurology (K.I.), New York University; and Department of Neurology (N.S.), Kaiser Permanente, Los Angeles, CA.'}]",Neurology,['10.1212/WNL.0000000000009443']
1569,32887793,Fatty Acid Supplementation and Socioemotional Outcomes: Secondary Analysis of a Randomized Trial.,"BACKGROUND AND OBJECTIVES


Children born preterm experience socioemotional difficulties, including increased risk of autism spectrum disorder (ASD). In this secondary analysis, we tested the effect of combined docosahexaenoic acid (DHA) and arachidonic acid (AA) supplementation during toddlerhood on caregiver-reported socioemotional outcomes of children born preterm. We hypothesized that children randomly assigned to DHA + AA would display better socioemotional outcomes compared with those randomly assigned to a placebo.
METHODS


Omega Tots was a single-site randomized, fully masked, parallel-group, placebo-controlled trial. Children ( N  = 377) were 10 to 16 months at enrollment, born at <35 weeks' gestation, and assigned to 180 days of daily 200-mg DHA + 200-mg AA supplementation or a placebo (400 mg corn oil). Caregivers completed the Brief Infant-Toddler Social and Emotional Assessment and the Pervasive Developmental Disorders Screening Test-II, Stage 2 at the end of the trial. Liner mixed models and log-binomial regression compared socioemotional outcomes between the DHA + AA and placebo groups.
RESULTS


Outcome data were available for 83% of children ( n   treatment  = 161;  n   placebo  = 153). Differences between DHA + AA and placebo groups on Brief Infant-Toddler Social and Emotional Assessment scores were of small magnitude (Cohen's  d  ≤ 0.15) and not statistically significant. Children randomly assigned to DHA + AA had a decreased risk of scoring at-risk for ASD on the Pervasive Developmental Disorders Screening Test-II, Stage 2 (21% vs 32%; risk ratio = 0.66 [95% confidence interval: 0.45 to 0.97]; risk difference = -0.11 [95% confidence interval: -0.21 to -0.01]) compared with children randomly assigned to a placebo.
CONCLUSIONS


No evidence of benefit of DHA + AA supplementation on caregiver-reported outcomes of broad socioemotional development was observed. Supplementation resulted in decreased risk of clinical concern for ASD. Further exploration in larger samples of preterm children and continued follow-up of children who received DHA + AA supplementation as they approach school age is warranted.",2020,Differences between DHA + AA and placebo groups on Brief Infant-Toddler Social and Emotional Assessment scores were of small magnitude (Cohen's  d  ≤ 0.15) and not statistically significant.,"['children born preterm', 'Children born preterm', ""Children ( N  = 377) were 10 to 16 months at enrollment, born at <35 weeks' gestation""]","['placebo', 'combined docosahexaenoic acid (DHA) and arachidonic acid (AA) supplementation', 'DHA + 200-mg AA supplementation or a placebo', 'Fatty Acid Supplementation and Socioemotional Outcomes', 'DHA + AA supplementation', 'DHA + AA']","['risk of clinical concern for ASD', 'Brief Infant-Toddler Social and Emotional Assessment scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0556098', 'cui_str': 'Arachidonic acid supplementation'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",377.0,0.782376,Differences between DHA + AA and placebo groups on Brief Infant-Toddler Social and Emotional Assessment scores were of small magnitude (Cohen's  d  ≤ 0.15) and not statistically significant.,"[{'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Boone', 'Affiliation': 'Centers for Biobehavioral Health and kelly.boone@nationwidechildrens.org.'}, {'ForeName': 'Andria', 'Initials': 'A', 'LastName': 'Parrott', 'Affiliation': 'Centers for Biobehavioral Health and.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rausch', 'Affiliation': 'Centers for Biobehavioral Health and.'}, {'ForeName': 'Keith Owen', 'Initials': 'KO', 'LastName': 'Yeates', 'Affiliation': ""Department of Psychology, Alberta Children's Hospital Research Institute and Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Klebanoff', 'Affiliation': 'Pediatrics, and.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Norris Turner', 'Affiliation': 'Division of Epidemiology, College of Public Health, and.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Keim', 'Affiliation': 'Centers for Biobehavioral Health and.'}]",Pediatrics,['10.1542/peds.2020-0284']
1570,32889373,Benefit-harm balance of fingolimod in patients with MS: A modelling study based on FREEDOMS.,"BACKGROUND


Fingolimod lowers the number of relapses in multiple sclerosis (MS) patients and slows down disease progression, but causes a broad spectrum of side effects. Our aim was to estimate the benefit-harm balance of fingolimod using individual patient data from FREEDOMS, a randomized controlled trial that compared two different dosages of fingolimod to placebo.
METHODS


We modelled the health status of patients over two years on a scale ranging from 0 (worst health or death) to 100 (maximum health). The model considered Expanded Disability Status Scale measurements, relapses and adverse events. We compared the mean health status between arms, and the proportion of trial participants for whom health declined or improved compared to baseline by a predefined minimal important difference of 4.6 or more.
RESULTS


The main analysis showed a net benefit for fingolimod 0.5mg compared to placebo, with an average health status difference over two years of 2.7 (95% CI 2.2 to 3.2). Patients on fingolimod 0.5mg were 0.53 (95% CI 0.40-0.72, p<0.001) times less likely to have a relevant decline in health status compared to patients on placebo, corresponding to a number needed to treat of 8 to prevent one relevant decline in health status. All sensitivity analyses favoured fingolimod 0.5mg.
CONCLUSION


Although fingolimod's net benefit did not reach the clinical relevance on average, the decreased risk for a decline in health over two years may be relevant. This approach could be applied to other MS drugs and provide an objective evidence base for guideline recommendations.",2020,"The main analysis showed a net benefit for fingolimod 0.5mg compared to placebo, with an average health status difference over two years of 2.7 (95% CI 2.2 to 3.2).","['patients with MS', 'patients over two years on a scale ranging from 0 (worst health or death) to 100 (maximum health']","['placebo', 'fingolimod to placebo']","['mean health status', 'Disability Status Scale measurements, relapses and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0681887', 'cui_str': 'Measurement scales'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.143984,"The main analysis showed a net benefit for fingolimod 0.5mg compared to placebo, with an average health status difference over two years of 2.7 (95% CI 2.2 to 3.2).","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Spanu', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland.'}, {'ForeName': 'Hélène E', 'Initials': 'HE', 'LastName': 'Aschmann', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Kesselring', 'Affiliation': 'RehaKliniken Valens, Zurich, Switzerland.'}, {'ForeName': 'Milo A', 'Initials': 'MA', 'LastName': 'Puhan', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland. Electronic address: miloalan.puhan@uzh.ch.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102464']
1571,32889425,Effectiveness of a social problem solving training in youth in detention or on probation: An RCT and pre-post community implementation.,"The effectiveness of a 10-session social problem-solving training (SPST) was evaluated in two independent studies in a juvenile justice (JJ) setting. In both studies, we aimed to examine main intervention effects on social problem-solving skills and recidivism, as well as differential effects as modulated by anger, anger regulation, and single nucleotide polymorphisms in the COMT gene. In Study 1, a randomized controlled trial (RCT), 289 male detainees (M age = 14.95 years) were randomly assigned to SPST or treatment-as-usual (TAU). In Study 2, a pre-post community implementation, 187 youth (M age  = 16.03 years) on probation were assessed before and after SPST. No significant main effects of SPST on social problem solving or recidivism were shown in either study. With regard to differential effects, among youth in detention,COMT haplotypes predicted intervention effects on state anger. Moreover, independent of SPST, inward anger expression was associated with an increase in state anger from pre- to post and an increase in state anger with a decrease in social problem solving. Among youth on probation, COMT haplotypes predicted social problem-solving skills, and, in turn, an increase in social problem-solving skills decreased the odds of recidivism after SPST. The lack of main effects of SPST may be due to low program integrity in JJ settings. Juveniles' emotional and genetic characteristics might modulate the effectiveness of interventions in JJ settings. We recommend studying large samples to substantiate this observation.",2020,No significant main effects of SPST on social problem solving or recidivism were shown in either study.,"['289 male detainees (M age =\xa014.95\xa0years', '187 youth (M age \xa0=\xa016.03\xa0years) on probation were assessed before and after SPST', 'youth in detention or on probation']","['social problem solving training', 'SPST or treatment-as-usual (TAU', '10-session social problem-solving training (SPST', 'SPST']","['social problem solving', 'social problem solving or recidivism', 'social problem-solving skills', 'state anger']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0425169', 'cui_str': 'On probation'}, {'cui': 'C0037431', 'cui_str': 'Social problem'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0037431', 'cui_str': 'Social problem'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0037431', 'cui_str': 'Social problem'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]",289.0,0.0357068,No significant main effects of SPST on social problem solving or recidivism were shown in either study.,"[{'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Hein', 'Affiliation': 'Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Weeland', 'Affiliation': 'Erasmus University Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Square', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Haeffel', 'Affiliation': 'University of Notre Dame, Notre Dame, IN, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chapman', 'Affiliation': 'Connecticut Judicial Branch, Court Support Services Division, Wethersfield, CT, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Macomber', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Foley Geib', 'Affiliation': 'Connecticut Judicial Branch, Court Support Services Division, Wethersfield, CT, USA.'}, {'ForeName': 'Elena L', 'Initials': 'EL', 'LastName': 'Grigorenko', 'Affiliation': 'Yale University, New Haven, CT, USA; University of Houston, Houston, TX, USA; Baylor College of Medicine, Houston, TX, USA. Electronic address: Elena.Grigorenko@times.uh.edu.'}]",International journal of law and psychiatry,['10.1016/j.ijlp.2020.101626']
1572,32891018,Effects of multimodal balance training supported by rhythmical auditory stimuli in people with advanced stages of Parkinson's disease: a pilot randomized clinical trial.,"Non-pharmacological interventions such as physiotherapy are recognized as important elements in the overall clinical management of motor impairments in PD, but evidence of physiotherapy in advanced disease stages is sparse. A recent trial found positive effects of multimodal balance training in people with mild to moderate PD, with greater and more sustained effects when rhythmical auditory stimuli were added. It is unclear whether such multimodal balance training is also effective in people with advanced PD (Hoehn & Yahr stage 4).
METHODS


We performed a pilot prospective single-blind, randomized clinical trial to study the effectiveness of multimodal training with and without rhythmical auditory stimuli. We screened 76 people with Parkinson's disease and Hoehn & Yahr stage 4 by telephone; 35 patients were assigned randomly into two groups: (1) multimodal balance training with rhythmical auditory stimuli (RAS-supported intervention, n = 17) and (2) multimodal balance training without rhythmical auditory cues (n = 18). Training was performed for 5 weeks, two times/week. Primary outcome was the Mini-BESTest (MBEST) score immediately after the training period. Assessments were performed by the same two blinded assessors at baseline, immediately post intervention, and after one and 6-months follow-up.
RESULTS


Immediately post-intervention, both intervention groups improved significantly on Mini-Best scores, without differences between both intervention modalities. In both groups, results were retained at one-month follow-up. At 6-months follow-up, the effects were retained only in the RAS-supported intervention group. For both intervention groups, no improvements were found on secondary outcome measures for gait.
CONCLUSION


Both RAS-supported multimodal balance training and regular multimodal balance training improve balance in PD patients in advanced disease stages. Effects appear to sustain longer in the RAS-supported training group.",2020,"For both intervention groups, no improvements were found on secondary outcome measures for gait.
","['PD patients in advanced disease stages', ""people with advanced stages of Parkinson's disease"", 'people with advanced PD (Hoehn & Yahr stage 4', 'people with mild to moderate PD', ""76 people with Parkinson's disease and Hoehn & Yahr stage 4 by telephone; 35 patients""]","['multimodal balance training with rhythmical auditory stimuli (RAS-supported intervention, n\xa0=\xa017) and (2) multimodal balance training without rhythmical auditory cues', 'multimodal balance training and regular multimodal balance training', 'multimodal balance training', 'multimodal training with and without rhythmical auditory stimuli']","['Mini-BESTest (MBEST) score', 'gait', 'Mini-Best scores', 'rhythmical auditory stimuli']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}]",76.0,0.0570846,"For both intervention groups, no improvements were found on secondary outcome measures for gait.
","[{'ForeName': 'Tamine T C', 'Initials': 'TTC', 'LastName': 'Capato', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands; University of São Paulo, Department of Neurology, Movement Disorders Center, São Paulo, Brazil. Electronic address: tamine.capato@radboudumc.nl.'}, {'ForeName': 'Jorik', 'Initials': 'J', 'LastName': 'Nonnekes', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour; Department of Rehabilitation, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands; Sint Maartenskliniek, Department of Rehabilitation, Nijmegen, the Netherlands.'}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'de Vries', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Radboud University Medical Center, Department for Health Evidence, Radboud Institute for Health Sciences, Nijmegen, the Netherlands.'}, {'ForeName': 'Egberto R', 'Initials': 'ER', 'LastName': 'Barbosa', 'Affiliation': 'University of São Paulo, Department of Neurology, Movement Disorders Center, São Paulo, Brazil.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117086']
1573,32891607,Partial sleep deprivation affects endurance performance and psychophysiological responses during 12-minute self-paced running exercise.,"PURPOSE


This study aimed to investigate the effects of partial sleep deprivation (PSD) on physical performance and psychophysiological responses during 12-minute self-paced running exercise.
METHODS


Twenty runners (20.8±1.1 years, 70.6±4.9 kg, 175.1±3.9 cm) performed, in a randomized order, two running self-paced field exercises after a normal sleep night (CONT, bedtime from 22:30 h to 06:30 h) and one night of PSD (bedtime from 00:30 h to 04:30 h). Core temperature and motivation were recorded before exercise. Speed, covered distance, heart rate (HR), rating of perceived exertion (RPE) and respiratory parameters (i.e., minute ventilation (VE), oxygen uptake (VO 2 ) and carbon dioxide production (VCO 2 )) were assessed during exercise. Blood lactate concentration [La] was assessed 2 min after exercise. Simple reaction time (SRT), mood and barrage test (BT) were assessed before and after exercise.
RESULTS


Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=-6% for covered distance), following PSD, were obtained compared to CONT. Similarly, PSD attenuated core temperature (p=0.01, d=0.84), HR (p=0.006, ɳp 2 =0.45), VE (p=0.001, ɳp 2 =0.73), VO 2  (p=0.001, ɳp 2 =0.96), BT (p<0.0005, ɳp 2 =0.86), SRT (p=0.0009, ɳp 2 =0.44) and mood (p<0.0005). However, VCO 2 , [La] and motivation score were not affected by sleep conditions.
CONCLUSION


The decrease of running performance and the increase of physical discomfort after PSD could be the origin of the lower cardio-respiratory responses to the 12-minute self-paced exercise. Effective strategies should be introduced to overcome the deterioration of physical performance and physiological responses after PSD.",2020,"RESULTS


Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=","['Twenty runners (20.8±1.1 years, 70.6±4.9 kg, 175.1±3.9 cm']","['12-minute self-paced running exercise', 'Partial sleep deprivation', 'running self-paced field exercises after a normal sleep night (CONT, bedtime from 22:30 h to 06:30 h) and one night of PSD', 'partial sleep deprivation (PSD']","['PSD attenuated core temperature', 'running performance', 'SRT', 'VCO 2 , [La] and motivation score', 'physical performance and psychophysiological responses', 'endurance performance and psychophysiological responses', 'Blood lactate concentration [La', 'Simple reaction times (SRT), mood and barrage test (BT', 'Core temperature and motivation', 'Speed, covered distance, heart rate (HR), rating of perceived exertion (RPE) and respiratory parameters (i.e., minute ventilation (VE), oxygen uptake (VO 2 ) and carbon dioxide production (VCO 2 ', 'lower physical performance', 'physical discomfort']","[{'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",,0.0445421,"RESULTS


Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=","[{'ForeName': 'Wajdi', 'Initials': 'W', 'LastName': 'Souissi', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Hammouda', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France; Research Laboratory, Molecular Bases of Human Pathology, LR19ES13, Faculty of Medicine, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ayachi', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Achraf', 'Initials': 'A', 'LastName': 'Ammar', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke University, Magdeburg, Germany.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khcharem', 'Affiliation': 'Research Laboratory, Education, Motricity, Sport and Health, UR15JS01, High Institute of Sport and Physical Education, University of Sfax, Tunisia; Laboratory of Pharmacology, Faculty of Medicine, University of Sfax, Tunisia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'de Marco', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Souissi', 'Affiliation': 'Research Laboratory, Education, Motricity, Sport and Health, UR15JS01, High Institute of Sport and Physical Education, University of Sfax, Tunisia.'}, {'ForeName': 'Tarak', 'Initials': 'T', 'LastName': 'Driss', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France. Electronic address: tarak.driss@parisnanterre.fr.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113165']
1574,32891639,Impact of Perioperative Multidisciplinary Rehabilitation Pathway on Early Outcomes after Robot-assisted Radical Cystectomy: A Matched Analysis.,"OBJECTIVE


To investigate the effect of incorporating physical rehabilitation, nutrition and psychosocial care as part of the ""NEEW"" (Nutrition, Exercise, patient Education and Wellness) on perioperative outcomes after robot-assisted radical cystectomy.
METHODS


Patients were divided into 2 groups: pathway group (NEEW in addition to enhanced recovery after surgery), vs prepathway group, before NEEW initiation (enhanced recovery after surgery only). Propensity score matching was performed (ratio 1:2 ratio). Perioperative outcomes were analyzed and compared. Multivariate analyses were modeled to assess for association between NEEW pathway and postoperative outcomes.
RESULTS


One hundred and niney-two were included in the study: 64 patients (33%) in the pathway group vs 128 patients (67%) in the prepathway group. Pathway group had shorter median inpatient stay (5 vs 6 days, P <.01), faster bowel recovery (3 vs 4 days, P <.01), and better pain scores, and demonstrated fewer 30-day high grade complications (5% vs 16%, P = .02). On multivariate analysis, the NEEW pathway was associated with shorter hospital stay (1.75 days shorter), faster bowel recovery (1 day faster), longer functional mobility time (4 minutes longer) and less pain scores (average 1 point less).
CONCLUSION


Standardized perioperative pathway with weekly multidisciplinary team meeting was associated with improved short-term perioperative outcomes after robot-assisted radical cystectomy.",2020,"Pathway group had shorter median inpatient stay (5 vs 6 days, p<0.01), faster bowel recovery (3 vs 4 days, p < 0.01), and better pain scores, and demonstrated fewer 30-day high grade complications (5% vs 16%, p=0.02).","['192 were included in the study: 64 patients (33%) in the pathway group vs. 128 patients (67%) in the pre-pathway group', 'Patients were divided into 2 groups']","['Robot-Assisted Radical Cystectomy (RARC', 'physical rehabilitation, nutrition and psychosocial care', 'Robot-Assisted Radical Cystectomy', 'pathway group (NEEW in addition to ERAS), versus pre-pathway group, before NEEW initiation (ERAS only']","['shorter median inpatient stay', 'shorter hospital stay', 'longer functional mobility time', 'faster bowel recovery', '30-day high grade complications', 'pain scores', 'Perioperative outcomes']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C1455743', 'cui_str': 'Psychosocial assessment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0420512', 'cui_str': 'Inpatient stay'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",192.0,0.0593086,"Pathway group had shorter median inpatient stay (5 vs 6 days, p<0.01), faster bowel recovery (3 vs 4 days, p < 0.01), and better pain scores, and demonstrated fewer 30-day high grade complications (5% vs 16%, p=0.02).","[{'ForeName': 'Naif A', 'Initials': 'NA', 'LastName': 'Aldhaam', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY.'}, {'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Elsayed', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Hussein', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY.'}, {'ForeName': 'Alat', 'Initials': 'A', 'LastName': 'Siam', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Osei', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Jing', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY.'}, {'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Babar', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Graton', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Kurtz', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychosocial Oncology, Roswell Park Comprehensive Cancer Center, NY.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Rowan', 'Affiliation': 'Department of Ambulatory Services, Roswell Park Comprehensive Cancer Center, NY.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Miller', 'Affiliation': 'Department of Physical Therapy, Roswell Park Comprehensive Cancer Center, NY.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY.'}, {'ForeName': 'Khurshid A', 'Initials': 'KA', 'LastName': 'Guru', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY. Electronic address: Khurshid.guru@roswellpark.org.'}]",Urology,['10.1016/j.urology.2020.05.113']
1575,32891678,The impact of shared decision making with patient decision aids on the rotavirus vaccination rate in children: A randomized controlled trial.,"Rotavirus vaccination reduces the incidence and severity of acute gastroenteritis due to rotavirus infection. However, because of a lack of understanding and private payment for the rotavirus vaccine, the rotavirus vaccination rate is still low in some countries. We intended to assess the impact of shared decision-making (SDM) with the assistance of patient decision aids (PDAs) on the rotavirus vaccination rate, and the knowledge, confidence, and congruence of value among baby's parents when decision-making. The study was a two-group, outcome assessor-blind, randomized, controlled trial. The families of 1-month-old infants for routine vaccination were enrolled; they were divided randomly into non-SDM and SDM groups. The influence of SDM on the acceptance of rotavirus vaccination was assessed when their infants were 2 months old. Outcome measures were decisional conflict, decision-making difficulties, and rotavirus vaccine knowledge, and the overall rotavirus vaccination rate. The study enrolled 180 participants. SDM, parents' education level, and rotavirus vaccination of a previous child were variables that influenced acceptance of rotavirus vaccination. The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus. The rotavirus vaccination rate was 16.7% higher in the SDM group than the non-SDM group. SDM assisted with PDAs gives more information and helps infants' families understand what they need, reduces their decision conflict, and increases their baby's vaccination against rotavirus, which promotes public health. The clinical trial is registered at ClinicalTrials.gov (NCT03804489).",2020,"The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus.","['children', '180 participants', 'families of 1-month-old infants for routine vaccination were enrolled']","['shared decision-making (SDM) with the assistance of patient decision aids (PDAs', 'Rotavirus vaccination', 'SDM', 'patient decision aids', 'SDM assisted with PDAs']","['acceptance of rotavirus vaccination', 'rotavirus vaccination rate', 'decisional conflict, decision-making difficulties, and rotavirus vaccine knowledge, and the overall rotavirus vaccination rate', 'rotavirus vaccination rate, and the knowledge, confidence, and congruence of value']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0857208', 'cui_str': 'Routine vaccination'}]","[{'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus vaccine'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",180.0,0.124641,"The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus.","[{'ForeName': 'Sheng-Chieh', 'Initials': 'SC', 'LastName': 'Lin', 'Affiliation': 'Division of Allergy, Asthma, and Immunology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. Electronic address: jacklinmails@yahoo.com.tw.'}, {'ForeName': 'Ka-Wai', 'Initials': 'KW', 'LastName': 'Tam', 'Affiliation': 'Division of General Surgery, Department of Surgery, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Division of General Surgery, Department of Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan; Shared Decision Making Resource Center, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: kelvintam@h.tmu.edu.tw.'}, {'ForeName': 'Jean Yu-Chun', 'Initials': 'JY', 'LastName': 'Yen', 'Affiliation': 'Research Center of Biostatistics, College of Management, Taipei Medical University, Taipei, Taiwan. Electronic address: jeanycy@tmu.edu.tw.'}, {'ForeName': 'Meng-Che', 'Initials': 'MC', 'LastName': 'Lu', 'Affiliation': 'Division of Allergy, Asthma, and Immunology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Elaine Ying-Fang', 'Initials': 'EY', 'LastName': 'Chen', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yung-Ting', 'Initials': 'YT', 'LastName': 'Kuo', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Neurology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: pedkuoyt@tmu.edu.tw.'}, {'ForeName': 'Wen-Chuan', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Pediatric Infectious Diseases, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: 09009@s.tmu.edu.tw.'}, {'ForeName': 'Shu-Huey', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Hematology and Oncology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: shu117@tmu.edu.tw.'}, {'ForeName': 'El-Wui', 'Initials': 'EW', 'LastName': 'Loh', 'Affiliation': 'Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan; Shared Decision Making Resource Center, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Center for Evidence-Based Health Care, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: lohelwui@tmu.edu.tw.'}, {'ForeName': 'Shih-Yen', 'Initials': 'SY', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Gastroenterology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: 18159@s.tmu.edu.tw.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106244']
1576,32891977,Social network heavy drinking moderates the effects of a brief motivational intervention for alcohol use among injured patients.,"BACKGROUND


Limited research has focused on identifying the extent to which social networks impact the effectiveness of brief alcohol interventions delivered in trauma care settings.
OBJECTIVES


The research presented here examines the extent to which the percent of heavy drinkers and percent of abstainers in one's social network moderates the effectiveness of a brief motivational intervention with and without a telephone booster on alcohol use among trauma patients.
METHOD


Secondary data analyses were conducted using data from 596 participants (456males) who were recruited from three urban Level I trauma centers. Patients were randomized to one of the three intervention conditions: brief advice (BA; n = 200), brief motivational intervention (BMI; n = 203), and BMI with a telephone booster (BMI + B; n = 193). For the purpose of the present study, measures of alcohol-specific social network characteristics at baseline and alcohol use at 3- and 6-month follow-up were used.
RESULTS


At low percentages (0% to ~7%) of people in one's social network who are heavy drinkers, there was a negative, statistically significant effect of the BMI conditions versus the BA condition on alcohol use. However, percent of abstainers did not moderate the effects of the BMI conditions.
CONCLUSION


The results suggest that the BMI and BMI + B conditions may be most effective among patients with no heavy drinkers in their social networks. BMIs may benefit from including a component that addresses having one or more heavy drinkers in one's social network.",2020,"Patients were randomized to one of the three intervention conditions: brief advice (BA; n = 200), brief motivational intervention (BMI; n = 203), and BMI with a telephone booster (BMI + B; n = 193).","['injured patients', 'trauma patients', 'Secondary data analyses were conducted using data from 596 participants (456males) who were recruited from three urban Level I trauma centers', 'patients with no heavy drinkers in their social networks']","['motivational intervention', 'motivational intervention with and without a telephone booster', 'brief advice (BA; n\xa0=\xa0200), brief motivational intervention (BMI; n\xa0=\xa0203), and BMI with a telephone booster (BMI\xa0+\xa0B; n\xa0=\xa0193']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C4319558', 'cui_str': '200'}]",[],596.0,0.015999,"Patients were randomized to one of the three intervention conditions: brief advice (BA; n = 200), brief motivational intervention (BMI; n = 203), and BMI with a telephone booster (BMI + B; n = 193).","[{'ForeName': 'Miriam J', 'Initials': 'MJ', 'LastName': 'Alvarez', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA. Electronic address: mjalvarez2@miners.utep.edu.'}, {'ForeName': 'Dylan K', 'Initials': 'DK', 'LastName': 'Richards', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Oviedo Ramirez', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106594']
1577,32890016,Effects of high-flow nasal oxygen during prolonged deep sedation on postprocedural atelectasis: A randomised controlled trial.,"BACKGROUND


Atelectasis is common in patients undergoing prolonged deep sedation outside the operating theatre. High-flow nasal oxygen (HFNO) produces positive airway pressure which, hypothetically, should improve lung atelectasis, but this has not been investigated.
OBJECTIVE


We investigated whether HFNO ameliorates postprocedural atelectasis and compared the influences of HFNO and facial oxygen by mask on postprocedural outcomes.
DESIGN


A single-blind, open-label single-institution randomised controlled trial.
SETTING


A single university hospital, from February 2017 to July 2019.
PATIENTS


A total of 59 patients undergoing computed tomography (CT)-guided hepatic tumour radiofrequency ablation were randomly allocated to two groups.
INTERVENTION


These patients randomly received HFNO (oxygen flow 10 l min before sedation and 50 l min during the procedure) or a conventional oxygen face mask (oxygen flow 10 l min) during the procedure.
MAIN OUTCOME MEASURES


Changes in the area of lung atelectasis calculated on the basis of chest CT images and also recovery profiles were compared between the two groups.
RESULTS


The two groups had comparable procedural profiles, but the HFNO group exhibited less postprocedural atelectasis than the face mask group (median [IQR] 7.4 [3.9 to 11.4%] vs. 10.5 [7.2 to 14.6%]; P = 0.0313). However, the numbers of patients requiring oxygen supplementation in the recovery room and during transport from the recovery room to the ward did not differ significantly between groups (24.1 vs. 50.0%; P = 0.0596).
CONCLUSION


Our results suggested that HFNO ameliorates lung atelectasis after prolonged deep sedation in patients receiving CT-guided hepatic tumour radiofrequency ablation.
TRIAL REGISTRATION


Clinicaltrials.gov Identifier: NCT03019354.",2020,"The two groups had comparable procedural profiles, but the HFNO group exhibited less postprocedural atelectasis than the face mask group (median [IQR] 7.4 [3.9 to 11.4%] vs. 10.5 [7.2 to 14.6%]; P = 0.0313).","['A single university hospital, from February 2017 to July 2019', '59 patients undergoing computed tomography (CT)-guided hepatic tumour radiofrequency ablation', 'patients undergoing prolonged deep sedation outside the operating theatre', 'patients receiving CT-guided hepatic tumour radiofrequency ablation']","['high-flow nasal oxygen', 'HFNO', 'computerised tomography', 'HFNO (oxygen flow 10\u200al\u200amin before sedation and 50\u200al\u200amin during the procedure) or a conventional oxygen face mask (oxygen flow 10\u200al\u200amin) during the procedure', 'High-flow nasal oxygen (HFNO']","['numbers of patients requiring oxygen supplementation', 'area of lung atelectasis calculated on the basis of chest CT images and', 'postprocedural atelectasis']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0023903', 'cui_str': 'Neoplasm of liver'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C1956064', 'cui_str': 'Sedation, Deep'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0029064', 'cui_str': 'Operating theatre'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",59.0,0.224667,"The two groups had comparable procedural profiles, but the HFNO group exhibited less postprocedural atelectasis than the face mask group (median [IQR] 7.4 [3.9 to 11.4%] vs. 10.5 [7.2 to 14.6%]; P = 0.0313).","[{'ForeName': 'Chung-Chih', 'Initials': 'CC', 'LastName': 'Shih', 'Affiliation': 'From the Department of Anaesthesiology (C-CS, Y-HC, Y-JH, P-JL, C-YW) and Department of Medical Imaging, National Taiwan University Hospital, Taipei, Taiwan, ROC (P-CL).'}, {'ForeName': 'Po-Chin', 'Initials': 'PC', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Yueh-Hsun', 'Initials': 'YH', 'LastName': 'Chuang', 'Affiliation': ''}, {'ForeName': 'Yi-Ju', 'Initials': 'YJ', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Pei-Jing', 'Initials': 'PJ', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Chun-Yu', 'Initials': 'CY', 'LastName': 'Wu', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001324']
1578,32890814,Did young women in South African informal settlements display increased agency after participating in the Stepping Stones and Creating Futures intervention? A qualitative evaluation.,"This paper investigates the impact of the Stepping Stones Creating Futures (SSCF) intervention on young women in informal settlements in eThekwini, South Africa. Specifically, whether following participation in the intervention the young women experienced a reduction in intimate partner violence, strengthened agency and shifted gender relations. Where changes occurred, it examines how they occurred, and barriers and enablers to change. SSCF is a gender transformative and livelihoods strengthening intervention using participatory, reflective small groups. Qualitative research was undertaken with fifteen women participating in the SSCF randomised control trial between 2015 and 2018. The women were followed over 18 months, participating in in-depth interviews at baseline, 12- and 18-months post intervention. To supplement these, eight women were involved in Photovoice work at baseline and 18 months and seven were included in ongoing participant observation. Data were analysed inductively. Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods. Despite these important shifts many women did not report a reduction in IPV. Nonetheless we argue most of the women, following the intervention, became more agentic. Drawing on the notion of 'distributed agency' as developed by Campbell and Mannell (2016), we show that SSCF bolstered the women's distributed agency. Distributed agency recognizes small agentic acts that women take, acts which to them are significant, it further notes that agency is temporal, fluid, dynamic and context specific. Women do not 'either have agency or not', rather being agentic depends on time, context and the particular incident. These findings provide an important contribution to the limited application of distributed agency and femininities work in informal settlements and are critical for policy and intervention science to reduce IPV and support women's agency.",2020,"Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods.","['young women in informal settlements in eThekwini, South Africa', 'fifteen women participating in the SSCF randomised control trial between 2015 and 2018', 'eight women were involved in Photovoice work at baseline and 18 months and seven were included in ongoing participant observation']","['SSCF', 'Stepping Stones Creating Futures (SSCF) intervention']","['communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods', 'intimate partner violence, strengthened agency and shifted gender relations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0558038', 'cui_str': 'Participant observation'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0233894', 'cui_str': 'Femininity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0242360', 'cui_str': 'Relations, Gender'}]",15.0,0.0551815,"Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods.","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Willan', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa. Electronic address: Samantha.willan@mrc.ac.za.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gibbs', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa; Centre for Rural Health, School of Nursing and Public Health, Mazisi Kunene Road, University of KwaZulu-Natal, Durban, 4041, South Africa.'}, {'ForeName': 'Nwabisa', 'Initials': 'N', 'LastName': 'Shai', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}, {'ForeName': 'Nolwazi', 'Initials': 'N', 'LastName': 'Ntini', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Petersen', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, Mazisi Kunene Road, University of KwaZulu-Natal, Durban, 4041, South Africa.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jewkes', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113302']
1579,32890855,Reading proficiency influences the effects of transcranial direct current stimulation: Evidence from selective modulation of dorsal and ventral pathways of reading in bilinguals.,"INTRODUCTION


tDCS can modulate reading which is processed by lexical (ventral) and sub-lexical (dorsal) pathways. Previous research indicates that pathway recruitment in bilinguals depends on a script's orthographic depth and a reader's proficiency with it. The effect of tDCS on each reading pathway has not been investigated in bilinguals. We stimulated the left dorsal and ventral pathways separately in Chinese-English (C-E) bilinguals to understand whether pathway-specific modulation by tDCS is possible and, if so, how it is influenced by orthographic depth and script proficiency.
METHODS


A double-blind, sham-controlled, within-subject experiment was designed wherein 16 balanced bilinguals received anodal tDCS in dorsal, ventral and sham sessions. Two tDCS montages of electrode sizes 5 × 5 cm 2  with 1) anode at CP5 and cathode at CZ, and 2) anode at TP7 and cathode at nape of the neck, were applied for stimulating the dorsal and ventral pathways respectively. Bilinguals were asked to read word lists for each language before and after stimulation. RTs for accurate trials were analysed using linear mixed-effect modelling that included proficiency scores for reading English pseudo-words (PW) and Chinese pinyin.
RESULTS


For both languages, word reading RTs were faster following dorsal pathway stimulation. The dorsal stimulation effect (change in RT) was negatively correlated with pseudoword reading and pinyin proficiency. Stimulation of the ventral pathway decreased RTs only for Chinese reading.
CONCLUSION


Dorsal and ventral reading pathways can be selectively modulated by tDCS in bilingual readers with dorsal (sub-lexical) pathway stimulation affecting reading in both scripts and ventral (lexical) pathway stimulation selectively affecting Chinese reading. Dorsal pathway tDCS effects are modulated by sub-lexical reading proficiency.",2020,Dorsal and ventral reading pathways can be selectively modulated by tDCS in bilingual readers with dorsal (sub-lexical) pathway stimulation affecting reading in both scripts and ventral (lexical) pathway stimulation selectively affecting Chinese reading.,[],"['anodal tDCS', 'tDCS']",['dorsal stimulation effect (change in RT'],[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0476543,Dorsal and ventral reading pathways can be selectively modulated by tDCS in bilingual readers with dorsal (sub-lexical) pathway stimulation affecting reading in both scripts and ventral (lexical) pathway stimulation selectively affecting Chinese reading.,"[{'ForeName': 'Sagarika', 'Initials': 'S', 'LastName': 'Bhattacharjee', 'Affiliation': 'Psychology, School of Social Sciences, Nanyang Technological University, Singapore.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Kashyap', 'Affiliation': 'Centre for Research and Development in Learning (CRADLE), Singapore.'}, {'ForeName': 'Beth Ann', 'Initials': 'BA', 'LastName': ""O'Brien"", 'Affiliation': 'Centre for Research in Child Development (CRCD), National Institute of Education, Singapore.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCloskey', 'Affiliation': 'Cognitive Science, Johns Hopkins University, Baltimore, United States.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Oishi', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, United States.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Desmond', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, United States.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Rapp', 'Affiliation': 'Cognitive Science, Johns Hopkins University, Baltimore, United States. Electronic address: brapp1@jhu.edu.'}, {'ForeName': 'S H Annabel', 'Initials': 'SHA', 'LastName': 'Chen', 'Affiliation': 'Psychology, School of Social Sciences, Nanyang Technological University, Singapore; Centre for Research and Development in Learning (CRADLE), Singapore; Lee Kong Chian School of Medicine (LKC Medicine), Nanyang Technological University, Singapore. Electronic address: annabelchen@ntu.edu.sg.'}]",Brain and language,['10.1016/j.bandl.2020.104850']
1580,32910418,"Correction to: The Effect of Rifampin on the Pharmacokinetics and Safety of Lorlatinib: Results of a Phase One, Open-Label, Crossover Study in Healthy Participants.","In the original article, the reference 4 has been published and cited incorrectly.",2020,"In the original article, the reference 4 has been published and cited incorrectly.",['Healthy Participants'],"['Rifampin', 'Lorlatinib']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C4080091', 'cui_str': 'Lorlatinib'}]",[],,0.0167416,"In the original article, the reference 4 has been published and cited incorrectly.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Global Product Development, Pfizer Oncology, New York, NY, USA. joseph.chen@pfizer.com.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Global Product Development, Clinical Pharmacology, Pfizer Oncology, La Jolla, CA, USA.'}, {'ForeName': 'Sylvester', 'Initials': 'S', 'LastName': 'Pawlak', 'Affiliation': 'Global Product Development, Pfizer Inc., New Haven, CT, USA.'}, {'ForeName': 'Leonard P', 'Initials': 'LP', 'LastName': 'James', 'Affiliation': 'Global Product Development, Pfizer Oncology, New York, NY, USA.'}, {'ForeName': 'Gerson', 'Initials': 'G', 'LastName': 'Peltz', 'Affiliation': 'Safety Surveillance and Risk Management, Pfizer Oncology, Groton, CT, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Global Product Development, Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Ginman', 'Affiliation': 'Global Product Development, Pfizer Inc., South Lyon, MI, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Bergeron', 'Affiliation': 'Global Product Development, Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Yazdi K', 'Initials': 'YK', 'LastName': 'Pithavala', 'Affiliation': 'Global Product Development, Clinical Pharmacology, Pfizer Oncology, La Jolla, CA, USA.'}]",Advances in therapy,['10.1007/s12325-020-01480-1']
1581,32911037,Chronotherapeutic efficacy of suvorexant on sleep quality and metabolic parameters in patients with type 2 diabetes and insomnia.,"AIMS


This study aimed to assess the chronotherapeutic efficacy of suvorexant on subjective sleep parameters and metabolic parameters in patients with type 2 diabetes and insomnia.
METHODS


Thirteen patients with type 2 diabetes who met the Pittsburg Sleep Quality index criteria for primary insomnia took suvorexant 20 mg/day (15 mg/day for ≥65 years) for 14 ± 2 weeks. The following parameters were assessed before and after the treatment: sleep diary for sleep duration and quality (i.e., sleep onset latency, waking after sleep onset, and sleep efficiency [sSE]), Insomnia Severity Index, clinical and biochemical data, continuous glucose monitoring (CGM), and validated self-administered questionnaire on food intake.
RESULTS


Suvorexant significantly improved sSE, abdominal circumference, and sucrose intake (all p < 0.05), but did not change HbA1c, CGM parameters, or body weight. Correlation analysis revealed that changes in sSE were associated with those in HbA1c and body weight (r = -0.61 and r = -0.66, respectively; both p < 0.05).
CONCLUSIONS


Suvorexant significantly improved sleep quality and obesity-associated parameters in patients with type 2 diabetes in 14 weeks. Improvements in sleep quality were associated with improvements in glycemic control. Sleep disorder treatment using suvorexant may provide metabolic benefits for patients with type 2 diabetes.",2020,"RESULTS


Suvorexant significantly improved sSE, abdominal circumference, and sucrose intake (all p<0.05), but did not change HbA1c, CGM parameters, or body weight.","['patients with type 2 diabetes in 14 weeks', 'Thirteen patients with type 2 diabetes who met the Pittsburg Sleep Quality index criteria for primary insomnia took suvorexant 20 mg/day (15 mg/day for ≥65 years) for 14±2 weeks', 'patients with type 2 diabetes and insomnia', 'patients with type 2 diabetes']",['suvorexant'],"['sleep quality and obesity-associated parameters', 'glycemic control', 'sleep diary for sleep duration and quality (i.e., sleep onset latency, waking after sleep onset, and sleep efficiency [sSE]), Insomnia Severity Index, clinical and biochemical data, continuous glucose monitoring (CGM), and validated self-administered questionnaire on food intake', 'HbA1c and body weight', 'change HbA1c, CGM parameters, or body weight', 'Chronotherapeutic efficacy', 'sleep quality and metabolic parameters', 'subjective sleep parameters and metabolic parameters', 'sleep quality', 'sSE, abdominal circumference, and sucrose intake']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0033139', 'cui_str': 'Primary insomnia'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3854984', 'cui_str': 'suvorexant 20 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C3179535', 'cui_str': 'suvorexant'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0556137', 'cui_str': 'Sucrose intake'}]",13.0,0.026373,"RESULTS


Suvorexant significantly improved sSE, abdominal circumference, and sucrose intake (all p<0.05), but did not change HbA1c, CGM parameters, or body weight.","[{'ForeName': 'Fukumi', 'Initials': 'F', 'LastName': 'Yoshikawa', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Fumika', 'Initials': 'F', 'LastName': 'Shigiyama', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Yasuyo', 'Initials': 'Y', 'LastName': 'Ando', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Miyagi', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Uchino', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Hirose', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kumashiro', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan. Electronic address: naoki.kumashiro@med.toho-u.ac.jp.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108412']
1582,32911132,A brief telephone-delivered peer intervention to encourage enrollment in medication for opioid use disorder in individuals surviving an opioid overdose: Results from a randomized pilot trial.,"BACKGROUND


Medication for opioid use disorder (MOUD) can decrease the risk of opioid overdose (OOD) in individuals with opioid use disorder. Peer recovery support services (PRSS) are increasingly used to promote MOUD engagement but evidence of their efficacy is limited. This study's objective was to evaluate a single 20-minute telephone-delivered PRSS intervention for increasing MOUD enrollment and decreasing recurring OODs.
METHOD


This single-site, randomized controlled pilot trial enrolled adults, primarily recruited from a syringe service program, with an opioid-positive urine drug screen (UDS) reporting having been treated for an OOD within the past 6 months. Participants (N = 80) were randomized to PRSS (n = 40) or Control (n = 40) condition with all participants receiving personally-tailored OOD education and naloxone. Outcome measures obtained at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization included verified MOUD enrollment (primary), self-reported OOD, and opioid use assessed by self-report and UDS.
RESULTS


Through 12-month follow-up, 32.5 % of PRSS, compared to 17.5 % of Control participants enrolled in MOUD (X 2  = 2.4, p = 0.12; odds ratio = 2.27 (0.79-6.49)). PRSS participants were significantly less likely to have experienced an OOD through 12-month follow-up (12.5 % of PRSS participants, 32.5 % of Control, p = 0.03). No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days. Based on self-report, PRSS had good acceptability for both the interventionists and participants.
CONCLUSIONS


The results suggest that further development and testing of this PRSS telephone intervention to encourage MOUD enrollment and reduce OOD may be warranted.",2020,No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days.,"['individuals with opioid use disorder', 'Participants (N = 80', 'individuals surviving an opioid overdose', 'enrolled adults, primarily recruited from a syringe service program, with an opioid-positive urine drug screen (UDS) reporting having been treated for an OOD within the past 6 months']","['PRSS', 'PRSS telephone intervention', 'Control (n = 40) condition with all participants receiving personally-tailored OOD education and naloxone', 'Peer recovery support services (PRSS', 'telephone-delivered PRSS intervention', 'telephone-delivered peer intervention']","['verified MOUD enrollment (primary), self-reported OOD, and opioid use assessed by self-report and UDS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0743300', 'cui_str': 'Urine drug screen positive'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}]",80.0,0.0748964,No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days.,"[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH, 45267, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108270']
1583,32891871,No tDCS augmented working memory training benefit in undergraduates rewarded with course credit.,"BACKGROUND


The goal of working memory (WM) training is to expand capacity of this executive function. Transcranial direct current stimulation (tDCS) paired with WM training is more consistent than either alone. We have reported that tDCS targeting frontal and/or parietal regions enhanced theta phase locking, reduced alpha power, and strengthened theta-gamma phase amplitude coupling.
OBJECTIVE


To determine whether tDCS to frontal or parietal sites optimized WM training gains we pre-registered a tDCS-WM training study.
METHODS


80 undergraduates were randomly assigned to one of four anodal tDCS montages: frontal (F4), parietal (P4), alternating (P4-F4), and sham (P4 or F4). Participants completed 5-training sessions over one week and returned for follow-up testing after 30 days of no-contact.
RESULTS


No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
CONCLUSIONS


This null finding marks a failure to replicate in undergraduates training benefits observed in graduate students. We argue that motivation is essential to elicit improved performance in training protocols.",2020,"No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
","['graduate students', '80 undergraduates']","['anodal tDCS montages: frontal (F4), parietal (P4), alternating (P4-F4), and sham (P4 or F4', 'Transcranial direct current stimulation (tDCS) paired with WM training', 'working memory (WM) training']",['trained or transfer task performance'],"[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",80.0,0.033538,"No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
","[{'ForeName': 'Jorja', 'Initials': 'J', 'LastName': 'Shires', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Carrasco', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA; University of California, Davis, Program in Neuroscience, Davis, CA, 95616, USA.'}, {'ForeName': 'Marian E', 'Initials': 'ME', 'LastName': 'Berryhill', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA. Electronic address: mberryhill@unr.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.08.015']
1584,32891892,A multicenter effectiveness trial of QEEG-informed neurofeedback in ADHD: Replication and treatment prediction.,"INTRODUCTION


Quantitative Electroencephalogram-(QEEG-)informed neurofeedback is a method in which standard neurofeedback protocols are assigned, based on individual EEG characteristics in order to enhance effectiveness. Thus far clinical effectiveness data have only been published in a small sample of 21 ADHD patients. Therefore, this manuscript aims to replicate this effectiveness in a new sample of 114 patients treated with QEEG-informed neurofeedback, from a large multicentric dataset and to investigate potential predictors of neurofeedback response.
METHODS


A sample of 114 patients were included as a replication sample. Patients were treated with standard neurofeedback protocols (Sensori-Motor-Rhythm (SMR), Theta-Beta (TBR), or Slow Cortical Potential (SCP) neurofeedback), in combination with coaching and sleep hygiene advice. The ADHD Rating Scale (ADHD-RS) and Pittsburgh Sleep Quality Index (PSQI) were assessed at baseline, every 10th session, and at outtake. Holland Sleep Disorder Questionnaire (HSDQ) was assessed at baseline and outtake. Response was defined as ≥25% reduction (R25), ≥50% reduction (R50), and remission. Predictive analyses were focused on predicting remission status.
RESULTS


In the current sample, response rates were 85% (R25), 70% (R50), and remission was 55% and clinical effectiveness was not significantly different from the original 2012 sample. Non-remitters exhibited significantly higher baseline hyperactivity ratings. Women who remitted had significantly shorter P300 latencies and boys who remitted had significantly lower iAPF's.
DISCUSSION


In the current sample, clinical effectiveness was replicated, suggesting it is possible to assign patients to a protocol based on their individual baseline QEEG to enhance signal-to-noise ratio. Furthermore, remitters had lower baseline hyperactivity scores. Likewise, female remitters had shorter P300 latencies, whereas boys who remitted have a lower iAPF. Our data suggests initial specificity in treatment allocation, yet further studies are needed to replicate the predictors of neurofeedback remission.",2020,"Women who remitted had significantly shorter P300 latencies and boys who remitted had significantly lower iAPF's.
","['21 ADHD patients', 'A sample of 114 patients were included as a replication sample', '114 patients treated with QEEG-informed neurofeedback, from a large multicentric dataset']","['standard neurofeedback protocols (Sensori-Motor-Rhythm (SMR), Theta-Beta (TBR), or Slow Cortical Potential (SCP) neurofeedback), in combination with coaching and sleep hygiene advice', 'QEEG']","['Holland Sleep Disorder Questionnaire (HSDQ', 'response rates', 'ADHD Rating Scale (ADHD-RS) and Pittsburgh Sleep Quality Index (PSQI', 'baseline hyperactivity scores', 'shorter P300 latencies', 'clinical effectiveness', 'baseline hyperactivity ratings']","[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0598312', 'cui_str': 'DNA replication'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439743', 'cui_str': 'Multicentric'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}]",114.0,0.0593453,"Women who remitted had significantly shorter P300 latencies and boys who remitted had significantly lower iAPF's.
","[{'ForeName': 'Noralie', 'Initials': 'N', 'LastName': 'Krepel', 'Affiliation': 'Dept. of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands; Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, The Netherlands.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Egtberts', 'Affiliation': 'neuroCare Group Netherlands, Nijmegen, The Netherlands.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Sack', 'Affiliation': 'Dept. of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Heinrich', 'Affiliation': 'Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, The Netherlands; neuroCare Group, Munich, Germany; kbo-Heckscher-Klinikum, Munich, Germany.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'neuroCare Group, Sydney, Australia.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': 'Dept. of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands; Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, The Netherlands; Dept. of Experimental Psychology, Utrecht University, Utrecht, The Netherlands. Electronic address: martijn@brainclinics.com.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102399']
1585,32891918,Working memory moderates the relation between the brain-derived neurotropic factor (BDNF) and psychotherapy outcome for depression.,"BACKGROUND


Insight into patient characteristics that predict response to treatment for major depressive disorder (MDD) may help to personalize treatment and improve outcomes. One mechanism that has been linked to the success of treatment for MDD is brain-derived neurotropic factor (BDNF). BDNF is implicated in learning and memory and may play a role in the effects of psychotherapy that involves changing cognitions and behaviors. In addition, only in individuals with low BDNF, low working memory capacity has been associated with increased symptoms of depression. However, the role of BDNF and working memory capacity in psychotherapy outcome is unclear. The aim of this study was to investigate the role of BDNF and its interaction with working memory capacity in psychotherapy outcomes for MDD.
METHOD


Adult patients with MDD were randomized to weekly or twice weekly sessions of cognitive behavioral therapy or interpersonal psychotherapy. BDNF Val66Met polymorphism (rs6265) (n = 138) was defined and serum BDNF was quantified before (n = 138) and after psychotherapy (n = 82).
RESULTS


Baseline serum BDNF and the Val66Met polymorphism were not associated with outcome and associations did not differ between treatment conditions. Working memory capacity significantly moderated the relation between baseline serum BDNF and outcome: high serum BDNF at baseline was related to less depressive symptoms following psychotherapy in the presence of high working memory capacity, but not low working memory capacity.
DISCUSSION


These findings, if replicated, might indicate that while BDNF may not be related to psychotherapy outcomes in general, they may play a role in the presence of specific learning processes such as working memory capacity.",2020,"RESULTS


Baseline serum BDNF and the Val66Met polymorphism were not associated with outcome and associations did not differ between treatment conditions.","['Adult patients with MDD', 'major depressive disorder (MDD']","['cognitive behavioral therapy or interpersonal psychotherapy', 'BDNF', 'brain-derived neurotropic factor (BDNF) and psychotherapy']","['serum BDNF', 'depressive symptoms', 'Baseline serum BDNF and the Val66Met polymorphism']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]",138.0,0.0539135,"RESULTS


Baseline serum BDNF and the Val66Met polymorphism were not associated with outcome and associations did not differ between treatment conditions.","[{'ForeName': 'Sanne J E', 'Initials': 'SJE', 'LastName': 'Bruijniks', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands; Department of Clinical Psychology and Psychotherapy, University of Freiburg, Freiburg, Germany. Electronic address: sanne.bruijniks@psychologie.uni-freiburg.de.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'van Grootheest', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Center, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Vrije Universiteit Amsterdam; GGZ InGeest Specialized Mental Health Care, Amsterdam, the Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'de Kluiver', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Center, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Vrije Universiteit Amsterdam; GGZ InGeest Specialized Mental Health Care, Amsterdam, the Netherlands.'}, {'ForeName': 'Christiaan H', 'Initials': 'CH', 'LastName': 'Vinkers', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Center, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Vrije Universiteit Amsterdam; Department of Anatomy and Neurosciences, Amsterdam University Medical Center, Amsterdam Neuroscience, Amsterdam, the Netherlands.'}, {'ForeName': 'Frenk', 'Initials': 'F', 'LastName': 'Peeters', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Penninx', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Center, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Vrije Universiteit Amsterdam; GGZ InGeest Specialized Mental Health Care, Amsterdam, the Netherlands.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Teunissen', 'Affiliation': 'Neurochemistry Lab, Department of Clinical Chemistry, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam Neuroscience, the Netherlands.'}, {'ForeName': 'Marcus J H', 'Initials': 'MJH', 'LastName': 'Huibers', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands; Department of Psychology, University of Pennsylvania, Philadelphia, United States.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.045']
1586,32889867,mTOR Inhibition Is Most Beneficial After Liver Transplantation for Hepatocellular Carcinoma in Patients With Active Tumors.,"OBJECTIVE


The aim of this study was to evaluate the survival benefit of sirolimus in patients undergoing liver transplantation (LT) for hepatocellular carcinoma (HCC) (exploratory analysis of the SiLVER-trial).
SUMMARY AND BACKGROUND DATA


Patients receiving LT) for HCC are at a high risk for tumor recurrence. Calcineurin inhibitors have shown evidence to promote cancer growth, whereas mammalian target of rapamycin (mTOR) inhibitors like sirolimus have anticancer effects. In the SiLVER-trial (Clinicaltrials.gov: NCT00355862), the effect of sirolimus on the recurrence of HCC after LT was investigated in a prospective randomized trial. Although the primary endpoint of improved disease-free survival (DFS) with sirolimus was not met, outcomes were improved for patients in the sirolimus-treatment arm in the first 3 to 5 years. To learn more about the key variables, a multivariate analysis was performed on the SiLVER-trial data.
PATIENTS AND METHODS


Data from 508 patients of the intention-to-treat analysis were included in exploratory univariate and multivariate models for overall survival (OS), DFS and a competing risk analysis for HCC recurrence.
RESULTS


Sirolimus use for ≥3 months after LT for HCC independently reduced the hazard for death in the multivariate analysis [hazard ratio (HR): 0.7 (95% confidence interval, CI: 0.52-0.96, P = 0.02). Most strikingly, patients with an alpha-fetoprotein (AFP) ≥10 ng/mL and having used sirolimus for ≥3 months, benefited most with regard to OS, DFS, and HCC-recurrence (HR: 0.49-0.59, P = 0.0079-0.0245).
CONCLUSIONS


mTOR-inhibitor treatment with sirolimus for ≥3 months improves outcomes in LT for HCC, especially in patients with AFP-evidence of higher tumor activity, advocating particularly for mTOR inhibitor use in this subgroup of patients.
CLINICAL TRIAL REGISTRATION


EudraCT: 2005-005362-36 CLINICALTRIALS.GOV:: NCT00355862.",2020,"RESULTS


Sirolimus use for ≥3 months after LT for HCC independently reduced the hazard for death in the multivariate analysis [hazard ratio (HR): 0.7 (95% confidence interval, CI: 0.52-0.96, P = 0.02).","['Data from 508 patients of the intention-to-treat analysis', 'Patients With Active Tumors', 'patients undergoing liver transplantation (LT) for hepatocellular carcinoma (HCC) (exploratory analysis of the SiLVER-trial', 'patients with an alpha-fetoprotein (AFP) ≥10']","['mTOR', 'sirolimus', 'Calcineurin inhibitors']","['OS, DFS, and HCC-recurrence', 'disease-free survival (DFS', 'overall survival (OS), DFS and a competing risk analysis for HCC recurrence', 'survival benefit', 'hazard for death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}]","[{'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.230694,"RESULTS


Sirolimus use for ≥3 months after LT for HCC independently reduced the hazard for death in the multivariate analysis [hazard ratio (HR): 0.7 (95% confidence interval, CI: 0.52-0.96, P = 0.02).","[{'ForeName': 'Andreas A', 'Initials': 'AA', 'LastName': 'Schnitzbauer', 'Affiliation': 'Universitätsklinikum Frankfurt, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Frankfurt am Main, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Filmann', 'Affiliation': 'Universitätsklinikum Frankfurt, Institut für Biostatistik und Mathematisches Modellierung, Frankfurt am Main, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Adam', 'Affiliation': 'Hôpital Paul Brousse, Centre Hépato Biliaire, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bachellier', 'Affiliation': 'Les Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre, Service de Chirurgie Générale, Hépatique, Endocrinienne, et Transplantation, Strasbourg, France.'}, {'ForeName': 'Wolf O', 'Initials': 'WO', 'LastName': 'Bechstein', 'Affiliation': 'Universitätsklinikum Frankfurt, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Frankfurt am Main, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Becker', 'Affiliation': 'Universitätsklinikum Schleswig-Holstein - Campus Kiel, Klinik für Allgemeine Chirurgie, Viszeral-, Thorax, Transplantations- und Kinderchirurgie, Kiel, Germany.'}, {'ForeName': 'Sherrie', 'Initials': 'S', 'LastName': 'Bhoori', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, National Cancer Institute Milan, Department of Surgery, Transplantation and Hepatobiliary Cancer Unit, Milano, Italy.'}, {'ForeName': 'Itxarone', 'Initials': 'I', 'LastName': 'Bilbao', 'Affiliation': ""Hospital Universitari Vall d'Hebron, Servicio de Cirugía General, Unidad de Trasplante Hepatico, Barcelona, Spain.""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Brockmann', 'Affiliation': 'Universitätsklinikum Münster, Klinik für Allgemein- und ViszeralchirurgieMünster, Germany.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Burra', 'Affiliation': 'Università degli Studi di Padova, Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche (DiSCOG), Padova, Italy.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chazoullières', 'Affiliation': ""Hôpital Saint Antoine, Federation d'Hepato-Gastro-Enterologie, Service d'Hepatologie, Paris, France.""}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Cillo', 'Affiliation': 'Università di Padova, Azienda Ospedaliera di Padova, Chirurgia Epatobiliare e Trapianto Epatico, Padova, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Colledan', 'Affiliation': 'Azienda Ospedaliera Papa Giovanni XXIII, Chirurgia terza e Chirurgia Toracica, Bergamo (BG), Italy.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Duvoux', 'Affiliation': ""Université Paris-Est Créteil Val-de-Marne, Centre Hospitalier Universitaire Henri-Mondor, Service d'Hepatologie et de Gastroenterologie, Unite d'Hepatologie et de Transplantation Hepatique, Paris, France.""}, {'ForeName': 'Tom M', 'Initials': 'TM', 'LastName': 'Ganten', 'Affiliation': 'Universitätsklinikum Heidelberg, Fürst Stirum Klinik Bruchsal, Bruchsal, Germany.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gugenheim', 'Affiliation': 'Centre Hospitalier Universitaire de Nice, Hôpital ARCHET 2, Service de Chirurgie Digestive, Centre de Transplantation Hépatique, Nice Cedex, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heise', 'Affiliation': 'Universitätsklinikum Frankfurt, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Frankfurt am Main, Germany.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'van Hoek', 'Affiliation': 'Leiden University Medical Center (LUMC), Dept. of Gastroenterology and Hepatology, Leiden, Netherlands.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Jamieson', 'Affiliation': ""Cambridge University Hospitals, NHS Foundation Trust, Addenbrooke's Hospital, Department of Surgery, Hills Road, Cambridge, United Kingdom.""}, {'ForeName': 'Koert P', 'Initials': 'KP', 'LastName': 'de Jong', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Department of Surgery, Div. of Hepato-Pancreatico-Biliary Surgery & Liver Transplantation, Groningen, Netherlands.'}, {'ForeName': 'Christian G', 'Initials': 'CG', 'LastName': 'Klein', 'Affiliation': 'Universitätsklinikum Essen, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Essen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Klempnauer', 'Affiliation': 'Medizinische Hochschule Hannover, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Hannover, Germany.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Kneteman', 'Affiliation': 'University of Alberta, Alberta Health Services Liver Transplant Program, Alberta, Canada.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Lerut', 'Affiliation': 'Institute for Experimental and Clinical Research (IREC), Université catholique Louvain(UCL), Brussels, Belgium.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Mäkisalo', 'Affiliation': 'Helsinki University Central Hospital, Division of Transplantation and Liver Surgery, Helsinki, Finland.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Mazzaferro', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, National Cancer Institute Milan, Department of Surgery, Transplantation and Hepatobiliary Cancer Unit, Milano, Italy.'}, {'ForeName': 'Darius F', 'Initials': 'DF', 'LastName': 'Mirza', 'Affiliation': 'University Hospitals Birmingham, NHS Foundation Trust, The Queen Elizabeth Hospital, Liver and Hepato-Pancreato-Biliary (HPB) Unit, Edgbaston, Birmingham, United Kingdom.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Nadalin', 'Affiliation': 'Klinikum der Universität Tübingen, Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Tübingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Neuhaus', 'Affiliation': 'Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Klinik für Allgemein-, Visceral- und Transplantationschirurgie, Berlin, Germany.'}, {'ForeName': 'George-Philippe', 'Initials': 'GP', 'LastName': 'Pageaux', 'Affiliation': ""CHRU de Montpellier, APEMAD, Hôpital Saint-Eloi, Service d'Hepato-Gastroentérologie et Transplantation Hepatique, Cedex 5, France.""}, {'ForeName': 'Antonio D', 'Initials': 'AD', 'LastName': 'Pinna', 'Affiliation': 'Universita di Bologna, Policlinico S. Orsola-Malpighi, Chirurgia Generale e dei Trapianti, Bologna, Italy.'}, {'ForeName': 'Jaques', 'Initials': 'J', 'LastName': 'Pirenne', 'Affiliation': 'UZ Leuven, Campus Gasthuisberg, Abdominale Transplantatiechirurgie, Leuven, Belgium.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Pratschke', 'Affiliation': 'Charité - Universitätsmedizin Berlin Augustenburger Platz 1, 13353 Berlin.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Powel', 'Affiliation': 'Royal Infirmary of Edinburgh, NHS Lothian, Hepatic-Pancreatico-Biliary Surgical Services and Edinburgh Transplant Unit, 51 Little France Crescent, Edinburgh, Scotland, United Kingdom.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Rentsch', 'Affiliation': 'Klinikum der Ludwig-Maximillians-Universität München-Großhadern, current affiliation: Klinikum Ingolstadt, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Ingolstadt, Germany.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Rizell', 'Affiliation': 'Sahlgrenska University Hospital, Department of Surgery and Transplantation, Göteborg, Sweden.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Rossi', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico IRCCS di Milano, Centro Trapianti Fegato, Pad Zonda I piano, Milano, Italy.""}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Rostaing', 'Affiliation': 'Department of Nephrology, Hemodialysis, Apheresis and Transplantation, Grenoble-Alpes University Hospital Center, Avenue du Maquis du Grésivaudan, La Tronche, France.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': ""Hopital St Luc, Centre Hospitalier de l'Université Montréal (CHUM), Hepatobiliary and Pancreatic Surgery Unit, Principal Pavillion, 1058 Rue St Denis Montreal, Quebec, Canada.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Scholz', 'Affiliation': 'Uppsala University Hospital, Deptartment for Transplant Surgery, Uppsala, Sweden.'}, {'ForeName': 'Utz', 'Initials': 'U', 'LastName': 'Settmacher', 'Affiliation': 'Universitätsklinikum Jena, Klinik für Allgemein-, Viszeral- und Gefässchirurgie, Jena, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Soliman', 'Affiliation': 'Medizinische Universität Wien, AKH- Wien, Universitätsklinik für Chirurgie, Abteilung für Transplantation, Vienna, Austria.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Strasser', 'Affiliation': 'Royal Prince Alfred Hospital, AW Morrow Gastroenterology, and Liver Centre and Liver Transplant Unit, Camperdown, Sydney, Australia.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Söderdahl', 'Affiliation': 'Karolinska University Hospital, Department of Transplantation Surgery, Stockholm, Sweden.'}, {'ForeName': 'Roberto I', 'Initials': 'RI', 'LastName': 'Troisi', 'Affiliation': 'Ghent University Hospital and Medical School, Hepato- Biliary and Pancreatic Surgery, Ghent, Belgium.'}, {'ForeName': 'Victor Sánchez', 'Initials': 'VS', 'LastName': 'Turrión', 'Affiliation': 'Hospital Universitario Puerta de Hierro-Majadahonda, Departamento de Cirugía, Unidad de Trasplante Hepático, Calle Manuel de Falla 1, Madrid, Spain.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Schlitt', 'Affiliation': 'University Hospital Regensburg, Department of Surgery, Franz-Josef-Strauss-Allee 11, Regensburg, Germany.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Geissler', 'Affiliation': 'University Hospital Regensburg, Department of Surgery and Section of Experimental Surgery, Franz-Josef-Strauss-Allee 11, Regensburg, Germany.'}]",Annals of surgery,['10.1097/SLA.0000000000004280']
1587,32889869,Efficacy and Safety of the Duodeno-Jejunal Bypass Liner in Patients With Metabolic Syndrome: A Multicenter Randomized Controlled Trial (ENDOMETAB).,"OBJECTIVE


The aim of this study was to compare the efficacy and safety of 12-month implantation of a duodeno-jejunal bypass liner (DJBL) with conventional medical care in patients with metabolic syndrome (MS).
SUMMARY BACKGROUND DATA


DJBL is an endoscopic device for treating obesity and related disorders. The persistence of favorable results after 6 months has not been tested in a controlled study.
METHODS


We conducted a multicenter randomized controlled trial, stratified by center and diabetes status. The primary endpoint was the remission of MS at 12 months. The secondary endpoints included body mass index (BMI), glucose control, blood pressure, and lipids, assessed at 12 months after implantation, and again, at 12 months after the removal of the DJBL. Up to 174 subjects were planned to be randomized into either the DJBL or the control arm at a 2:1 ratio, respectively. Study enrollment was discontinued by the Scientific Monitoring Committee due to the early termination of the ENDO trial (NCT01728116) by the US Food and Drug Administration. The study was terminated after withdrawal of the device's European Conformity marking by the European Medicines Agency, and an interim analysis was performed.
RESULTS


A total of 82 patients were enrolled (67.5% female, 48.8% with diabetes). At 12 months after randomization, the primary endpoint was met in 6 (12%) DJBL patients and 3 (10%) controls (P = 0.72). Patients in the DJBL group experienced greater BMI loss [mean adjusted difference (95% confidence interval, CI) -3.1 kg/m (-4.4 to -1.9) kg/m, P < 0.001] and HbA1c change [mean adjusted difference -0.5% (95% CI -0.9 to -0.2); P < 0.001] than those in the control group. No difference remained statistically significant at 12 months after the removal of the DJBL. In the DJBL group, 39% of patients experienced at least one device-related serious adverse event, which was classified as Grade III Dindo-Clavien in 22%, and required premature device explantation in 16%.
CONCLUSIONS


The present study showed a transient clinical benefit of DJBL, which was only apparent at 1 year, when the device was still in situ, and was obtained at the risk of serious device-related adverse events in 39% of patients. These results do not support the routine use of DJBL for weight loss and glucose control in patients with MS.",2020,No difference remained statistically significant at 12 months after the removal of the DJBL.,"['Patients With Metabolic Syndrome', '174 subjects', 'patients with MS', 'patients with metabolic syndrome (MS', 'A total of 82 patients were enrolled (67.5% female, 48.8% with diabetes']","['Duodeno-Jejunal Bypass Liner', 'duodeno-jejunal bypass liner (DJBL) with conventional medical care']","['body mass index (BMI), glucose control, blood pressure, and lipids, assessed at 12 months after implantation, and again', 'efficacy and safety', 'BMI loss', 'Efficacy and Safety', 'weight loss and glucose control', 'remission of MS', 'premature device explantation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0022378', 'cui_str': 'Jejunal'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0181663', 'cui_str': 'Liner'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0561946', 'cui_str': 'Removal of implant'}]",174.0,0.238675,No difference remained statistically significant at 12 months after the removal of the DJBL.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Caiazzo', 'Affiliation': 'University Lille, Inserm, CHU Lille, Institut Pasteur Lille U1190 Translational Research for Diabetes, European Genomic Institute for Diabetes, Integrated Center of Obesity, Lille, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Branche', 'Affiliation': 'CHU Lille, Department of Gastroenterology, Lille, France.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Raverdy', 'Affiliation': 'University Lille, Inserm, CHU Lille, Institut Pasteur Lille U1190 Translational Research for Diabetes, European Genomic Institute for Diabetes, Integrated Center of Obesity, Lille, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Czernichow', 'Affiliation': ""University of Paris, Paris, France, AP-HP, Department of Nutrition, Centre spécialisé de l'Obesité Ile-de-France Sud, Hôpital Européen Georges Pompidou, Paris, France.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Carette', 'Affiliation': ""University of Paris, Paris, France, AP-HP, Department of Nutrition, Centre spécialisé de l'Obesité Ile-de-France Sud, Hôpital Européen Georges Pompidou, Paris, France.""}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Robert', 'Affiliation': 'Department of Digestive and Bariatric Surgery, Integrated Center of Obesity, Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Disse', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, Integrated Center of Obesity, Hospices Civils de Lyon, Hôpital Lyon Sud, Pierre Benite, France, CarMeN Laboratory, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Barthet', 'Affiliation': ""Service d'Hépato-gastroentérologie, Hôpital Nord, Marseille, France.""}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Cariou', 'Affiliation': ""Clinique d'endocrinologie, L'institut du thorax, CHU Nantes, Nantes, France.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Msika', 'Affiliation': 'Department of General, Digestive and Metabolic Surgery, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Behal', 'Affiliation': 'University Lille, CHU Lille, ULR 2694-METRICS: Évaluation des technologies de santé et des pratiques médicales, Lille, France.'}, {'ForeName': 'Fanette', 'Initials': 'F', 'LastName': 'Denies', 'Affiliation': ""Délégation à la Recherche Clinique et à l'Innovation (DRCI), CHU Lille, Lille, France.""}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Dervaux', 'Affiliation': ""Délégation à la Recherche Clinique et à l'Innovation (DRCI), CHU Lille, Lille, France.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Duhamel', 'Affiliation': 'University Lille, CHU Lille, ULR 2694-METRICS: Évaluation des technologies de santé et des pratiques médicales, Lille, France.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Verkindt', 'Affiliation': 'University Lille, Inserm, CHU Lille, Institut Pasteur Lille U1190 Translational Research for Diabetes, European Genomic Institute for Diabetes, Integrated Center of Obesity, Lille, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Pattou', 'Affiliation': 'University Lille, Inserm, CHU Lille, Institut Pasteur Lille U1190 Translational Research for Diabetes, European Genomic Institute for Diabetes, Integrated Center of Obesity, Lille, France.'}]",Annals of surgery,['10.1097/SLA.0000000000004339']
1588,32896527,"Early visual cortex response for sound in expert blind echolocators, but not in early blind non-echolocators.","Echolocation is a perceptual and navigational skill that can be acquired by some individuals. Regarding blind people, this skill can help them ""see"" the environment around them via a new form of auditory information based on echoes. Expert human echolocators benefit from using this technique not only in controlled environments but also in their everyday lives. In the current study, we investigate the effect of echolocation on blind people's auditory spatial abilities at the cortical level. In an auditory spatial bisection task, we tested people who are early blinds and early blind expert echolocators, along with sighted people. Our results showed that there is similar early activation (50-90 ms) in the posterior area of the scalp for both early blind expert echolocators and sighted participants, but not in the early blind group. This activation was related to sound stimulation, and it is contralateral to the position of the sound in space. These findings indicate that echolocation is a good substitute for the visual modality that enables the development of auditory spatial representations when vision is not available.",2020,"Regarding blind people, this skill can help them ""see"" the environment around them via a new form of auditory information based on echoes.","['people who are early blinds and early blind expert echolocators, along with sighted people']",['echolocation'],['Early visual cortex response'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0013529', 'cui_str': 'Echolocation'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0042817', 'cui_str': 'Visual Cortex'}]",,0.0717283,"Regarding blind people, this skill can help them ""see"" the environment around them via a new form of auditory information based on echoes.","[{'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Tonelli', 'Affiliation': 'UVIP, Unit for Visually Impaired People, Istituto Italiano di Tecnologia, Genova, Italy; Department of Translational Research of New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy. Electronic address: tonelli.alessia@gmail.com.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Campus', 'Affiliation': 'UVIP, Unit for Visually Impaired People, Istituto Italiano di Tecnologia, Genova, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gori', 'Affiliation': 'UVIP, Unit for Visually Impaired People, Istituto Italiano di Tecnologia, Genova, Italy.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107617']
1589,32896644,Transcranial direct current stimulation: A novel approach in the treatment of vascular depression.,"BACKGROUND


Despite the impact of depression in terms of personal suffering and socioeconomic burden, most currently available treatment options are often ineffective. A particularly difficult-to-treat depressive disorder characteristic of the elderly is vascular depression, a late-life depressive syndrome related to a variety of potential vascular mechanisms. Transcranial Direct Current Stimulation (tDCS), a non-invasive and effective somatic approach to depression, also showed positive effects on cognitive deficits.
AIM


We performed a double-blind randomized study to investigate the efficacy of tDCS as augmentation strategy to sertraline in the treatment of vascular depression, hypothesizing a positive effect in both depressive symptoms and cognitive functions.
METHODS


We enrolled 93 inpatients over 60 years of age with a diagnosis of vascular depression. Depressive symptoms were weekly assessed (T0, T1, T2) with the 21-items Hamilton depression rating scale (HDRS). Cognitive functioning was evaluated with the Milan Overall Dementia Assessment (MODA) at baseline and after the treatment protocol. All patients were randomly assigned into three groups, Group I: one tDCS stimulation per day, Group II: two tDCS stimulations per day, Sham group: one sham tDCS stimulation per day. Stimulation was performed for 10 consecutive working days.
RESULTS


A significant interaction time∗treatment was observed on HDRS scores (F = 14, p < 0.001). All groups improved at T1 but whereas Group II significantly differed from the Sham group (p < 0.001) we observed no difference between Sham and Group I. At T2 all groups improved but Group II showed the greater improvement (vs. Sham p < 0.001; vs. Group I p < 0.001) and the Sham group the smallest (vs. Group I p = 0.005). A significant interaction time∗treatment was also observed on MODA scores (F = 3.31, p = 0.04). Only subjects treated with tDCS improved at T2 (Group I: p < 0.001; Group II: p = 0.007). However, no difference between Group I and II was shown.
CONCLUSION


tDCS as augmentation treatment of an adequate pharmacotherapy is a potential strategy in the management of vascular depression, a disease known to be often unresponsive to antidepressants only. Non-invasiveness, the absence of severe side effects and the possibility of administering it to outpatients at an affordable price make tDCS an important tool in clinical practice.",2020,At T2 all groups improved but Group II showed the greater improvement (vs. Sham p<0.001;,['93 inpatients over 60 years of age with a diagnosis of vascular depression'],"['sertraline', 'tDCS stimulation per day, Group II: two tDCS stimulations per day, Sham group: one sham tDCS stimulation per day', 'Transcranial Direct Current Stimulation (tDCS', 'Transcranial direct current stimulation', 'tDCS']","['MODA scores', 'Depressive symptoms', '21-items Hamilton depression rating scale (HDRS', 'HDRS scores']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",93.0,0.13066,At T2 all groups improved but Group II showed the greater improvement (vs. Sham p<0.001;,"[{'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Zanardi', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Mood Disorder Unit, Milan, Italy; University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy. Electronic address: zanardi.raffaella@hsr.it.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Poletti', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Prestifilippo', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Attanasio', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Barbini', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Mood Disorder Unit, Milan, Italy; University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Colombo', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Mood Disorder Unit, Milan, Italy; University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}]",Brain stimulation,['10.1016/j.brs.2020.08.013']
1590,32897117,Re: Effect of Intensive vs Standard Blood Pressure Treatment upon Erectile Function in Hypertensive Men: Findings from the Systolic Blood Pressure Intervention Trial.,,2020,,['Hypertensive Men'],['Intensive vs Standard Blood Pressure Treatment'],[],"[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0373286,,"[{'ForeName': 'Allen D', 'Initials': 'AD', 'LastName': 'Seftel', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001252.03']
1591,32897125,Re: Effect on Patient Safety of a Resident Physician Schedule without 24-Hour Shifts.,,2020,,[],['Resident Physician Schedule without 24-Hour Shifts'],[],[],"[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]",[],,0.0332029,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Resnick', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001256.01']
1592,32897150,Re: Randomized Study of Systematic Biopsy versus Magnetic Resonance Imaging and Targeted and Systematic Biopsy in Men on Active Surveillance (ASIST): 2-Year Postbiopsy Follow-Up.,,2020,,['Men on Active Surveillance (ASIST'],['Systematic Biopsy versus Magnetic Resonance Imaging and Targeted and Systematic Biopsy'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",[],,0.0661264,,"[{'ForeName': 'Samir S', 'Initials': 'SS', 'LastName': 'Taneja', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001261.02']
1593,32897182,Early Mobilization Versus Splinting After Surgical Management of Distal Radius Fractures.,"BACKGROUND


After the surgical management of distal radius fractures (DRF) in older patients, further treatment with a splint often follows. It is unclear whether early mobilization might be superior to splinting in this group of patients, as it is in others. In this prospective, randomized, controlled trial, we attempted to determine whether early mobilization yields better outcomes.
METHODS


50 patients over age 70 with DRF were included in the trial. Group A (the splint group) was treated with postoperative immobilization, group B with early mobilization. Clinical follow-up examinations were performed at 2, 6, and 12 weeks and at 6 and 12 months. X-rays were obtained preoperatively, postoperatively, at 6 weeks, and at 6 months. The primary outcome parameter was the modified Mayo Wrist Score (MMWS) at 6 weeks.
RESULTS


At 6 weeks, the functional outcome was better to a statistically significant extent in group B (MMWS; 65/100 vs. 55/100 [q25 : 55/40 - q75 : 70/70; p = 0.025]). No difference between the two groups was demonstrable in their further clinical course. The estimated regression model revealed a statistically significant effect of the method of treatment (p = 0.023). There were no differences in hand strength or in x-ray findings.
DISCUSION


Early mobilization is associated with better wrist function on initial follow-up, without any demonstrable disadvantage with respect to secondary dislocation. The psychological benefit and protective function of wrist splinting in patients who are in danger of falling should nonetheless be investigated in further studies.",2020,"There were no differences in hand strength or in x-ray findings.
","['Distal Radius Fractures', 'older patients', '50 patients over age 70 with DRF were included in the trial']","['postoperative immobilization, group B with early mobilization', 'Early Mobilization Versus Splinting']","['hand strength', 'functional outcome', 'modified Mayo Wrist Score (MMWS']","[{'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0204861', 'cui_str': 'Application of splint'}]","[{'cui': 'C0242959', 'cui_str': 'Hand Strength'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",50.0,0.0354781,"There were no differences in hand strength or in x-ray findings.
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Zeckey', 'Affiliation': 'Department of Trauma and Reconstructive Surgery, University Hospital Munich, Ludwig-Maximilians-Universität München; Department of Trauma Surgery and Orthopedics, RoMed Klinikum Rosenheim; Statistical Consulting Unit StaBLab, Department of Statistics, Ludwig-Maximilians-Universität München.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Späth', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kieslich', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kammerlander', 'Affiliation': ''}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Böcker', 'Affiliation': ''}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Weigert', 'Affiliation': ''}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Neuerburg', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2020.0445']
1594,32898517,Cardiac autonomic and blood pressure responses to an acute session of battling ropes exercise.,"BACKGROUND


Battling rope (BTR) exercise has become incredibly popular among not only fitness enthusiasts and athletes but in the general exercising population. Despite its popularity, research regarding the acute cardiovascular responses to BTR exercise is limited. This investigation evaluated the effects of acute BTR exercise on heart rate variability (HRV) and blood pressure (BP) responses in young men with elevated BP.
MATERIALS AND METHODS


Eleven young men with elevated BP completed either a BTR or a non-exercise control trial in randomized order. The BTR trial consisted of 10 rounds of BTR exercise. Each round included 30 s of exercise followed by 30 s of rest. HRV and BP were evaluated at baseline and 3, 10, and 30 min following each trial.
RESULTS


There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 min following the BTR trial, whereas no changes from baseline were detected after control. Additionally, there were significant reductions (p ˂0.01) in markers of vagal tone (RMSSD, LnHF and nHF) and LnLF (both sympathetic and vagal modulations) for 30 min; as well as (p ˂0.01) systolic BP and diastolic BP at 10 and 30 min after the BTR, but not the control trial.
CONCLUSION


Current findings revealed that BTR exercise elevates sympathovagal balance for 30 min post-intervention, which is concurrent with an impressive hypotensive effect. Further investigations are warranted to assess the potential clinical application of BTR exercise not only in cohorts needing BP control but also in populations with limited locomotion that might benefit from post-exercise hypotension.",2020,"There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 minutes following the BTR trial, whereas no changes from baseline were detected after control.","['young men with elevated BP', 'Eleven young men with elevated BP completed either a']","['Battling rope (BTR) exercise', 'BTR or a non-exercise control', 'acute BTR exercise', 'BTR exercise']","['systolic BP and diastolic BP', 'sympathovagal balance', 'heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF', 'Cardiac Autonomic and Blood Pressure Responses', 'HRV and BP', 'heart rate variability (HRV) and blood pressure (BP) responses', 'vagal tone (RMSSD, LnHF and nHF) and LnLF (both sympathetic and vagal modulations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",11.0,0.10577,"There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 minutes following the BTR trial, whereas no changes from baseline were detected after control.","[{'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States. Electronic address: awong@marymount.edu.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Bergen', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nordvall', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Allnutt', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113167']
1595,32898699,N-Glycome changes reflecting resistance to platinum-based chemotherapy in ovarian cancer.,"A number of studies have reported aberrant glycosylation in connection with malignancy. Our investigation further expands on this topic through the examination of N-glycans, which could be associated with the resistance of advanced stage, high-grade non-mucinous ovarian cancer to platinum/taxane based chemotherapy. We used tissue samples of 83 ovarian cancer patients, randomly divided into two independent cohorts (basic and validation). Both groups involved either cases with/without postoperative tumor residue or the cases determined either resistant or sensitive to this chemotherapy. In the validation cohort, preoperative serum samples were also available. N-glycans released from tumors and sera were permethylated and analyzed by matrix-assisted laser desorption/ionization mass spectrometry (MALDI-MS). The MS analysis yielded a consecutive detection of 68 (tissue) and 63 (serum) N-glycan spectral signals. Eight of these were found to be differentially abundant in tissues of both independent cohorts including the cases with a postoperative cancer residue. One of these glycans was detected as differentially abundant in sera of the validation cohort. No statistically significant differences in intensities due to the same N-glycans were found in the cases without postoperative macroscopic residues in either the basic or validation cohort. From the biochemical point of view, the statistically significant N-glycans correspond to the structures carrying bisecting (terminal) GlcNAc residue and tetra-antennary structures with sialic acid and/or fucose residues. Among them, six tissue N-glycans could be considered potential markers connected with a resistance to chemotherapy in ovarian cancer patients. The prediction of primary resistance to standard chemotherapy may identify the group of patients suitable for alternative treatment strategies. SIGNIFICANCE: Drug resistance has become a major impediment to a successful treatment of patients with advanced ovarian cancer. The glycomic measurements related to cancer are becoming increasingly popular in identification of the key molecules as potential diagnostic and prognostic indicators. Our report deals with identification of differences in N-glycosylation of proteins in tissue and serum samples from the individuals showing sensitivity or resistance to platinum/taxane-based chemotherapy. The detection sensitivity to chemotherapy is vitally important for these patients.",2020,No statistically significant differences in intensities due to the same N-glycans were found in the cases without postoperative macroscopic residues in either the basic or validation cohort.,"['patients with advanced ovarian cancer', 'ovarian cancer', '83 ovarian cancer patients', 'ovarian cancer patients']","['platinum/taxane-based chemotherapy', 'platinum-based chemotherapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}]","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]",[],83.0,0.0192624,No statistically significant differences in intensities due to the same N-glycans were found in the cases without postoperative macroscopic residues in either the basic or validation cohort.,"[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Zahradnikova', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Ihnatova', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic; Recetox, Masaryk University, Kamenice 753/5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Lattova', 'Affiliation': 'Central European Institute of Technology, Masaryk University, Kamenice 753/5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Uhrik', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Eliska', 'Initials': 'E', 'LastName': 'Stuchlikova', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Nenutil', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Dalibor', 'Initials': 'D', 'LastName': 'Valik', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Nalezinska', 'Affiliation': 'Department of Gynecologic Oncology, Masaryk Memorial Cancer Institute, Zluty kopec 7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Chovanec', 'Affiliation': 'Department of Gynecologic Oncology, Masaryk Memorial Cancer Institute, Zluty kopec 7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Zbynek', 'Initials': 'Z', 'LastName': 'Zdrahal', 'Affiliation': 'Central European Institute of Technology, Masaryk University, Kamenice 753/5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Borivoj', 'Initials': 'B', 'LastName': 'Vojtesek', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Hernychova', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic. Electronic address: lenka.hernychova@mou.cz.'}, {'ForeName': 'Milos V', 'Initials': 'MV', 'LastName': 'Novotny', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic; Department of Chemistry, Indiana University, 800 E. Kirkwood Avenue, Bloomington, IN 47405, USA. Electronic address: novotny@indiana.edu.'}]",Journal of proteomics,['10.1016/j.jprot.2020.103964']
1596,32899135,Impact of a Three-Year Obesity Prevention Study on Healthy Behaviors and BMI among Lebanese Schoolchildren: Findings from Ajyal Salima Program.,"Most school-based obesity prevention programs in low- to middle-income countries are of short duration, and few undertake follow-up analyses after the termination of the project. The aims of the current study are to investigate (1) the long-term effects of a school-based intervention program when implemented over two years on body mass index (BMI), healthy dietary behaviors, and physical activity (PA); and (2) whether the effects are sustained after one-year washout. The study is a cluster-randomized trial; 36 public and private schools were randomized into either intervention or control groups. Students (8-12 years) completed pre-and post-assessment anthropometric measurements and questionnaires about their eating and physical activity habits. Students in the intervention groups received the program components for two consecutive years. Multiple logistic regression models were used to examine the effect of the intervention on BMI and healthy behaviors. Students in the intervention groups were less likely to be overweight at washout, only in public schools. The number of children reporting change in dietary behaviors significantly increased in intervention groups, with a sustained effect only in public schools. Policies aiming at securing a positive nutrition environment in schools, and adoption of nutrition programs, are needed for achieving sustained behavior and prompting BMI changes in children.",2020,"The number of children reporting change in dietary behaviors significantly increased in intervention groups, with a sustained effect only in public schools.","['Healthy Behaviors and BMI among Lebanese Schoolchildren', '36 public and private schools']",['school-based intervention program'],"['body mass index (BMI), healthy dietary behaviors, and physical activity (PA', 'BMI and healthy behaviors', 'dietary behaviors']","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",36.0,0.0164201,"The number of children reporting change in dietary behaviors significantly increased in intervention groups, with a sustained effect only in public schools.","[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Habib-Mourad', 'Affiliation': 'Department of Nutrition and Food Sciences, Faculty of Agriculture and Food Sciences, American University of Beirut, Beirut 11-0236, Lebanon.'}, {'ForeName': 'Lilian A', 'Initials': 'LA', 'LastName': 'Ghandour', 'Affiliation': 'Department of Epidemiology and Population Health, Faculty of Health Sciences, American University of Beirut, Beirut 11-0236, Lebanon.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Maliha', 'Affiliation': 'Department of Nutrition and Food Sciences, Faculty of Agriculture and Food Sciences, American University of Beirut, Beirut 11-0236, Lebanon.'}, {'ForeName': 'Michèle', 'Initials': 'M', 'LastName': 'Dagher', 'Affiliation': 'Department of Nutrition and Food Sciences, Faculty of Agriculture and Food Sciences, American University of Beirut, Beirut 11-0236, Lebanon.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Kharroubi', 'Affiliation': 'Department of Nutrition and Food Sciences, Faculty of Agriculture and Food Sciences, American University of Beirut, Beirut 11-0236, Lebanon.'}, {'ForeName': 'Nahla', 'Initials': 'N', 'LastName': 'Hwalla', 'Affiliation': 'Department of Nutrition and Food Sciences, Faculty of Agriculture and Food Sciences, American University of Beirut, Beirut 11-0236, Lebanon.'}]",Nutrients,['10.3390/nu12092687']
1597,32719045,Historically controlled comparison of glucocorticoids with or without tocilizumab versus supportive care only in patients with COVID-19-associated cytokine storm syndrome: results of the CHIC study.,"OBJECTIVES


To prospectively investigate in patients with severe COVID-19-associated cytokine storm syndrome (CSS) whether an intensive course of glucocorticoids with or without tocilizumab accelerates clinical improvement, reduces mortality and prevents invasive mechanical ventilation, in comparison with a historic control group of patients who received supportive care only.
METHODS


From 1 April 2020, patients with COVID-19-associated CSS, defined as rapid respiratory deterioration plus at least two out of three biomarkers with important elevations (C-reactive protein >100 mg/L; ferritin >900 µg/L; D-dimer >1500 µg/L), received high-dose intravenous methylprednisolone for 5 consecutive days (250 mg on day 1 followed by 80 mg on days 2-5). If the respiratory condition had not improved sufficiently (in 43%), the interleukin-6 receptor blocker tocilizumab (8 mg/kg body weight, single infusion) was added on or after day 2. Control patients with COVID-19-associated CSS (same definition) were retrospectively sampled from the pool of patients (n=350) admitted between 7 March and 31 March, and matched one to one to treated patients on sex and age. The primary outcome was ≥2 stages of improvement on a 7-item WHO-endorsed scale for trials in patients with severe influenza pneumonia, or discharge from the hospital. Secondary outcomes were hospital mortality and mechanical ventilation.
RESULTS


At baseline all patients with COVID-19 in the treatment group (n=86) and control group (n=86) had symptoms of CSS and faced acute respiratory failure. Treated patients had 79% higher likelihood on reaching the primary outcome (HR: 1.8; 95% CI 1.2 to 2.7) (7 days earlier), 65% less mortality (HR: 0.35; 95% CI 0.19 to 0.65) and 71% less invasive mechanical ventilation (HR: 0.29; 95% CI 0.14 to 0.65). Treatment effects remained constant in confounding and sensitivity analyses.
CONCLUSIONS


A strategy involving a course of high-dose methylprednisolone, followed by tocilizumab if needed, may accelerate respiratory recovery, lower hospital mortality and reduce the likelihood of invasive mechanical ventilation in COVID-19-associated CSS.",2020,"Treated patients had 79% higher likelihood on reaching the primary outcome (HR: 1.8; 95% CI 1.2 to 2.7) (7 days earlier), 65% less mortality (HR: 0.35; 95% CI 0.19 to 0.65) and 71% less invasive mechanical ventilation (HR: 0.29; 95% CI 0.14 to 0.65).","['patients with severe COVID-19-associated cytokine storm syndrome (CSS', 'From 1 April 2020, patients with COVID-19-associated CSS, defined as rapid respiratory deterioration plus at least two out of three biomarkers with important elevations (C-reactive protein >100\u2009mg/L; ferritin >900\u2009µg/L; D-dimer >1500\u2009µg/L', 'comparison with a historic control group of patients who received supportive care only', 'Control patients with COVID-19-associated CSS (same definition) were retrospectively sampled from the pool of patients (n=350) admitted between 7 March and 31 March, and matched one to one to treated patients on sex and age', 'patients with COVID-19-associated cytokine storm syndrome']","['interleukin-6 receptor blocker tocilizumab', 'methylprednisolone', 'glucocorticoids with or without tocilizumab', 'tocilizumab']","['≥2 stages of improvement on a 7-item WHO-endorsed scale', 'severe influenza pneumonia, or discharge from the hospital', 'hospital mortality and mechanical ventilation', 'symptoms of CSS and faced acute respiratory failure', 'invasive mechanical ventilation', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0919747', 'cui_str': 'Cytokine storm'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0155870', 'cui_str': 'Pneumonia and influenza'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0919747', 'cui_str': 'Cytokine storm'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",3.0,0.16573,"Treated patients had 79% higher likelihood on reaching the primary outcome (HR: 1.8; 95% CI 1.2 to 2.7) (7 days earlier), 65% less mortality (HR: 0.35; 95% CI 0.19 to 0.65) and 71% less invasive mechanical ventilation (HR: 0.29; 95% CI 0.14 to 0.65).","[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Ramiro', 'Affiliation': 'Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands sofiaramiro@gmail.com.'}, {'ForeName': 'Rémy L M', 'Initials': 'RLM', 'LastName': 'Mostard', 'Affiliation': 'Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Magro-Checa', 'Affiliation': 'Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Christel M P', 'Initials': 'CMP', 'LastName': 'van Dongen', 'Affiliation': 'Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Dormans', 'Affiliation': 'Department of Intensive Care, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Buijs', 'Affiliation': 'Department of Internal Medicine, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Gronenschild', 'Affiliation': 'Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Martijn D', 'Initials': 'MD', 'LastName': 'de Kruif', 'Affiliation': 'Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Eric H J', 'Initials': 'EHJ', 'LastName': 'van Haren', 'Affiliation': 'Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'van Kraaij', 'Affiliation': 'Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Mathie P G', 'Initials': 'MPG', 'LastName': 'Leers', 'Affiliation': 'Department of Clinical Chemistry and Hematology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Peeters', 'Affiliation': 'Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Dennis R', 'Initials': 'DR', 'LastName': 'Wong', 'Affiliation': 'Department of Clinical Pharmacy, Pharmacology and Toxicology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Robert B M', 'Initials': 'RBM', 'LastName': 'Landewé', 'Affiliation': 'Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-218479']
1598,32911474,Fluoride Varnish in Nursery Schools: A Randomised Controlled Trial - Protecting Teeth @3.,"Studies suggest that fluoride varnish (FV) application can reduce dental caries in child populations. The multiple-component national child oral health improvement programme in Scotland (Childsmile) includes nursery-based universal supervised toothbrushing and deprivation-targeted FV applications, together with community and dental practice prevention interventions. This trial, a double-blind, two-arm randomised control trial, aimed to assess the effectiveness and cost-effectiveness of the nursery-based FV applications plus treatment-as-usual (TAU) Childsmile programme interventions, compared to TAU Childsmile interventions alone, in children not targeted to receive nursery FV as part of the programme. Participating children in the first year of nursery (aged three), with or without existing caries, were randomised to either FV or TAU and followed up for 24 months until the first year of primary school. Treatments were administered at six-monthly intervals. The primary endpoint was ""worsening of d3mft"" from baseline to 24 months. Secondary endpoints were worsening of d3mfs, d3t, mt, and ft. Individual record-linkage captured wider programme activities and tertiary endpoints. A total of 1,284 children were randomised, leading to 1,150 evaluable children (n = 577 FV, n = 573 TAU, 10% dropouts). Mean age was 3.5 years, 50% were female (n = 576), 17% had caries at baseline (n = 195), all balanced between the groups. Most children received three/four treatments. Overall, 26.9% (n = 155) had worsened d3mft in the FV group, and 31.6% (n = 181) in the TAU group, with an odds ratio (OR) of 0.80 (0.62-1.03), p = 0.078. The results for worsening of the secondary endpoints were: d3mfs 0.79 (0.61-1.01) p = 0.063, d3t 0.75 (0.57-0.99) p = 0.043, mt 1.34 (0.75-2.39) p = 0.319, and ft 0.77 (0.53-1.14) p = 0.191. We calculated a number needed to treat of 21 and a cost of GBP 686 to prevent a single worsening of d3mft. There was a modest non-significant reduction in the worsening of d3mft in the nursery FV group compared to TAU, suggesting that this intervention is unlikely to represent an effective or cost-effective addition to the population oral health improvement programme.",2020,"There was a modest non-significant reduction in the worsening of d3mft in the nursery FV group compared to TAU, suggesting that this intervention is unlikely to represent an effective or cost-effective addition to the population oral health improvement programme.","['1,284 children were randomised, leading to 1,150 evaluable children (n = 577 FV, n = 573', 'children not targeted to receive nursery FV as part of the programme', 'Nursery Schools', 'child populations', 'Mean age was 3.5 years, 50% were female (n = 576), 17% had caries at baseline (n = 195), all balanced between the groups', 'Participating children in the first year of nursery (aged three), with or without existing caries']","['FV or TAU', 'fluoride varnish (FV) application', 'Fluoride Varnish', 'nursery-based FV applications plus treatment-as-usual (TAU) Childsmile programme interventions']","['effectiveness and cost-effectiveness', 'worsening of d3mft', 'worsening of d3mfs, d3t, mt, and ft']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C0028659', 'cui_str': 'Nurseries'}, {'cui': 'C0036379', 'cui_str': 'Nursery school'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0028659', 'cui_str': 'Nurseries'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}]",1284.0,0.209769,"There was a modest non-significant reduction in the worsening of d3mft in the nursery FV group compared to TAU, suggesting that this intervention is unlikely to represent an effective or cost-effective addition to the population oral health improvement programme.","[{'ForeName': 'Alex D', 'Initials': 'AD', 'LastName': 'McMahon', 'Affiliation': 'Community Oral Health, University of Glasgow Dental School (MVLS), Glasgow, United Kingdom, alex.mcmahon@glasgow.ac.uk.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wright', 'Affiliation': 'Community Oral Health, University of Glasgow Dental School (MVLS), Glasgow, United Kingdom.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Anopa', 'Affiliation': 'Community Oral Health, University of Glasgow Dental School (MVLS), Glasgow, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McIntosh', 'Affiliation': 'Health Economic and Health Technology Assessment, Institute of Health and Wellbeing (MVLS), University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Turner', 'Affiliation': 'Community Oral Health, University of Glasgow Dental School (MVLS), Glasgow, United Kingdom.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Conway', 'Affiliation': 'Community Oral Health, University of Glasgow Dental School (MVLS), Glasgow, United Kingdom.'}, {'ForeName': 'Lorna M D', 'Initials': 'LMD', 'LastName': 'Macpherson', 'Affiliation': 'Community Oral Health, University of Glasgow Dental School (MVLS), Glasgow, United Kingdom.'}]",Caries research,['10.1159/000509680']
1599,32911505,On the developmental origin of intrinsic honesty.,"Contrary to the self-interestedness assumption, numerous economic studies have documented that people are intrinsically honest. However, little is known about this trait's developmental origin. This study examines whether and the extent to which children in early childhood incur the intrinsic lying cost. We modified the commonly used coin-flip task into a child-friendly ball-drawing task with 10 trials and conducted the experiment with 225 child participants aged three to eight years old. We found that-although young children, on average, told two lies in the task (an average winning rate of 71%)-they lied significantly less than the maximum level (i.e., lying 100% of the time). The pattern was largely similar across gender and the age range studied. Furthermore, our child subjects' propensity to lie dropped by approximately 9% when they were randomly assigned to the treatment condition with an increased ""perceived"" intrinsic cost of lying. Overall, our results align with the innate morality hypothesis: young children, as young as three years old, are willing to give up pecuniary rewards in order to remain honest.",2020,"Overall, our results align with the innate morality hypothesis: young children, as young as three years old, are willing to give up pecuniary rewards in order to remain honest.",['225 child participants aged three to eight years old'],[],[],"[{'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],[],225.0,0.0162522,"Overall, our results align with the innate morality hypothesis: young children, as young as three years old, are willing to give up pecuniary rewards in order to remain honest.","[{'ForeName': 'Tai-Sen', 'Initials': 'TS', 'LastName': 'He', 'Affiliation': 'Economics Programme, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': 'Department of Psychology, National University of Singapore, Singapore, Singapore.'}]",PloS one,['10.1371/journal.pone.0238241']
1600,32897605,"Transesophageal Echocardiography - Dysphagia Risk in Acute Stroke (TEDRAS): a prospective, blind, randomized and controlled clinical trial.","BACKGROUND AND PURPOSE


Dysphagia is common in acute stroke and leads to worse overall outcome. Transesophageal echocardiography (TEE) is used in the diagnostic evaluation of stroke with regard to its etiology and is a known cause of postoperative dysphagia in cardiac surgery. The prevalence of dysphagia in acute stroke patients undergoing TEE remains unknown. The aim of the Transesophageal Echocardiography - Dysphagia Risk in Acute Stroke (TEDRAS) study was to assess the influence of TEE on swallowing among patients who have experienced acute stroke.
METHODS


The TEDRAS study was a prospective, blind, randomized, controlled trial that included two groups of patients with acute stroke. Simple unrestricted randomization was performed, and examiners were blinded to each other's results. Swallowing was tested using flexible endoscopic evaluation of swallowing (FEES) at three different time points in the intervention group (24 h before, immediately after and 24 h after TEE) and in the control group (FEES on three consecutive days and TEE earliest after the third FEES). Validated scales were used to assess dysphagia severity for all time points as primary outcome measures.
RESULTS


A total of 34 patients were randomized: 19 to the intervention group and 15 to the control group. The key findings of the repeated-measures between-group comparisons were significant increases in the intervention group for the following dysphagia measures: (1) secretion severity score (immediately after TEE: P < 0.001; 24 h after TEE: P < 0.001) and (2) Penetration-Aspiration Scale score for saliva (immediately after TEE: P < 0.001; 24 h after TEE: P = 0.007), for small (immediately after TEE: P = 0.009) and large liquid boli (immediately after TEE: P = 0.009; 24 h after TEE: P = 0.025).
CONCLUSION


The results indicate a negative influence of TEE on swallowing in acute stroke patients for at least 24 hours.",2020,"Swallowing was tested using Flexible Endoscopic Evaluation of Swallowing (FEES) at three different intervals in the intervention group (IG) (24 hours before, immediately after and 24 hours after TEE) and within the control group (CG)","['34 patients', 'acute stroke patients', 'Acute Stroke', 'acute stroke patients undergoing TEE remains unknown', 'patients with acute stroke in two groups']","['CG', 'TEE', 'Transesophageal echocardiography (TEE', 'Transesophageal Echocardiography - Dysphagia Risk', 'control group (CG']","['dysphagia severity', 'Flexible Endoscopic Evaluation of Swallowing (FEES', 'Penetration-aspiration-scale for saliva', 'prevalence of dysphagia', 'Secretion severity score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",34.0,0.0945988,"Swallowing was tested using Flexible Endoscopic Evaluation of Swallowing (FEES) at three different intervals in the intervention group (IG) (24 hours before, immediately after and 24 hours after TEE) and within the control group (CG)","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hamzic', 'Affiliation': 'Department of Neurology, University Hospital Giessen and Marburg GmbH, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Braun', 'Affiliation': 'Department of Neurology, University Hospital Giessen and Marburg GmbH, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Butz', 'Affiliation': 'Department of Neurology, University Hospital Giessen and Marburg GmbH, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Khilan', 'Affiliation': 'Department of Neurology, University Hospital Giessen and Marburg GmbH, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Weber', 'Affiliation': 'Department of Neurology/Stroke Unit, Gesundheitszentrum Wetterau, Friedberg, Hesse, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yeniguen', 'Affiliation': 'Department of Neurology, University Hospital Giessen and Marburg GmbH, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gerriets', 'Affiliation': 'Department of Neurology, University Hospital Giessen and Marburg GmbH, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schramm', 'Affiliation': 'Heart and Brain Research Group, Heart-, Lung-, Vascular- and Rheumatic Centre Bad Nauheim, Kerckhoff Clinic GmbH, Bad Nauheim, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Juenemann', 'Affiliation': 'Department of Neurology, University Hospital Giessen and Marburg GmbH, Justus-Liebig-University, Giessen, Germany.'}]",European journal of neurology,['10.1111/ene.14516']
1601,32897665,Effect of Electrical Muscle Stimulation on Upper and Lower Limb Muscles in Critically Ill Patients: A Two-Center Randomized Controlled Trial.,"OBJECTIVES


Electrical muscle stimulation is widely used to enhance lower limb mobilization. Although upper limb muscle atrophy is common in critically ill patients, electrical muscle stimulation application for the upper limbs has been rarely reported. The purpose of this study was to investigate whether electrical muscle stimulation prevents upper and lower limb muscle atrophy and improves physical function.
DESIGN


Randomized controlled trial.
SETTING


Two-center, mixed medical/surgical ICU.
PATIENTS


Adult patients who were expected to be mechanically ventilated for greater than 48 hours and stay in the ICU for greater than 5 days.
INTERVENTIONS


Forty-two patients were randomly assigned to the electrical muscle stimulation (n = 17) or control group (n = 19).
MEASUREMENTS AND MAIN RESULTS


Primary outcomes were change in muscle thickness and cross-sectional area of the biceps brachii and rectus femoris from day 1 to 5. Secondary outcomes included occurrence of ICU-acquired weakness, ICU mobility scale, length of hospitalization, and amino acid levels. The change in biceps brachii muscle thickness was -1.9% versus -11.2% in the electrical muscle stimulation and control (p = 0.007) groups, and the change in cross-sectional area was -2.7% versus -10.0% (p = 0.03). The change in rectus femoris muscle thickness was -0.9% versus -14.7% (p = 0.003) and cross-sectional area was -1.7% versus -10.4% (p = 0.04). No significant difference was found in ICU-acquired weakness (13% vs 40%; p = 0.20) and ICU mobility scale (3 vs 2; p = 0.42) between the groups. The length of hospitalization was shorter in the electrical muscle stimulation group (23 d [19-34 d] vs 40 d [26-64 d]) (p = 0.04). On day 3, the change in the branched-chain amino acid level was lower in the electrical muscle stimulation group (40.5% vs 71.5%; p = 0.04).
CONCLUSIONS


In critically ill patients, electrical muscle stimulation prevented upper and lower limb muscle atrophy and attenuated proteolysis and decreased the length of hospitalization.",2020,No significant difference was found in ICU-acquired weakness (13% vs 40%; p = 0.20) and ICU mobility scale (3 vs 2; p = 0.42) between the groups.,"['Two-center, mixed medical/surgical ICU', 'Critically Ill Patients', 'Adult patients who were expected to be mechanically ventilated for greater than 48 hours and stay in the ICU for greater than 5 days']","['Electrical Muscle Stimulation', 'electrical muscle stimulation']","['cross-sectional area', 'electrical muscle stimulation prevented upper and lower limb muscle atrophy and attenuated proteolysis', 'biceps brachii muscle thickness', 'ICU-acquired weakness', 'length of hospitalization', 'branched-chain amino acid level', 'occurrence of ICU-acquired weakness, ICU mobility scale, length of hospitalization, and amino acid levels', 'change in muscle thickness and cross-sectional area of the biceps brachii and rectus femoris from day 1 to 5', 'change in rectus femoris muscle thickness', 'ICU mobility scale']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1513053', 'cui_str': 'Medical Surgical Nursing'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0597304', 'cui_str': 'Protein Degradation'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C4087120', 'cui_str': 'Intensive care unit acquired weakness'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1328436', 'cui_str': 'Amino acid level'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",42.0,0.0549303,No significant difference was found in ICU-acquired weakness (13% vs 40%; p = 0.20) and ICU mobility scale (3 vs 2; p = 0.42) between the groups.,"[{'ForeName': 'Nobuto', 'Initials': 'N', 'LastName': 'Nakanishi', 'Affiliation': 'Emergency and Critical Care Medicine, Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Oto', 'Affiliation': 'Emergency and Disaster Medicine, Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Tsutsumi', 'Affiliation': 'Department of Nutrition and Metabolism, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Nutrition and Metabolism, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Yoshitoyo', 'Initials': 'Y', 'LastName': 'Ueno', 'Affiliation': 'Emergency and Critical Care Medicine, Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Nakataki', 'Affiliation': 'Intensive Care Medicine, Tokushima Prefectural Central Hospital, Tokushima, Japan.'}, {'ForeName': 'Taiga', 'Initials': 'T', 'LastName': 'Itagaki', 'Affiliation': 'Emergency and Critical Care Medicine, Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Sakaue', 'Affiliation': 'Department of Nutrition and Metabolism, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Masaji', 'Initials': 'M', 'LastName': 'Nishimura', 'Affiliation': 'Intensive Care Medicine, Tokushima Prefectural Central Hospital, Tokushima, Japan.'}]",Critical care medicine,['10.1097/CCM.0000000000004522']
1602,32898787,"Calorie restriction and synbiotics effect on quality of life and edema reduction in breast cancer-related lymphedema, a clinical trial.","BACKGROUND


Little evidence exists regarding the clinical value of synbiotics in the management of post-treatment complications of breast cancer especially breast cancer-related lymphedema (BCRL). This study aimed to investigate the effects of synbiotic supplementation along with calorie restriction on quality of life and edema volume in patients with BCRL.
METHODS


This randomized, placebo-controlled, clinical trial was conducted on 135 overweight and obese women with BCRL aged 18-65 years old. Participants were randomly allocated to receive a calorie-restricted diet plus 10 9  CFU synbiotic supplement (CRS group; n = 45) or placebo (CRP group; n = 45), daily for 10 weeks. Also, a control group (n = 45) with no intervention was included in the trial. All of the participants received Complete Decongestive Therapy for lymphedema treatment. The quality of life score, edema volume and body mass index (BMI) were measured at baseline and end of the trial.
RESULTS


A total of 121 subjects completed the trial. CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control. However, there were no significant differences in changes in trial outcomes between the CRS and CRP groups.
CONCLUSION


Synbiotic supplementation along with a low-calorie diet was effective in quality of life, edema volume, and BMI improvement; mostly due to low-calorie diet. It seems that adding a dietitian consultation on the lymphedema management strategy may provide a better result in lymphedema control.",2020,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","['patients with BCRL', 'breast cancer-related lymphedema', '135 overweight and obese women with BCRL aged 18-65 years old', 'breast cancer especially breast cancer-related lymphedema (BCRL', '121 subjects completed the trial']","['synbiotic supplementation', 'CRS', 'Synbiotic supplementation', 'placebo', 'calorie-restricted diet plus 10 9 \xa0CFU synbiotic supplement (CRS group; n\xa0=\xa045) or placebo (CRP', 'calorie restriction', 'Complete Decongestive Therapy']","['BMI', 'quality of life, edema volume, and BMI improvement', 'quality of life and edema volume', 'edema volume', 'quality of life score, edema volume and body mass index (BMI', 'total quality of life score', 'quality of life and edema reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0474212', 'cui_str': 'Reduction of edema'}]",135.0,0.165473,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","[{'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Zarrati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: zarrati_ms@yahoo.com.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Malakootinejad', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali Saneei', 'Initials': 'AS', 'LastName': 'Totmaj', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Zayeri', 'Affiliation': 'Proteomics Research Center and Department of Biostatistics, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Biostatistics, School of Public Health, Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Sanati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahpar', 'Initials': 'S', 'LastName': 'Haghighat', 'Affiliation': 'Breast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran. Electronic address: sha_haghighat@yahoo.com.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.08.008']
1603,32899289,Caloric and Macronutrient Intake and Meal Timing Responses to Repeated Sleep Restriction Exposures Separated by Varying Intervening Recovery Nights in Healthy Adults.,"Sleep restriction (SR) reliably increases caloric intake. It remains unknown whether such intake cumulatively increases with repeated SR exposures and is impacted by the number of intervening recovery sleep opportunities. Healthy adults (33.9 ± 8.9y; 17 women, Body Mass Index: 24.8 ± 3.6) participated in a laboratory protocol. N = 35 participants experienced two baseline nights (10 h time-in-bed (TIB)/night; 22:00-08:00) followed by 10 SR nights (4 h TIB/night; 04:00-08:00), which were divided into two exposures of five nights each and separated by one (n = 13), three (n = 12), or five (n = 10) recovery nights (12 h TIB/night; 22:00-10:00). Control participants (n = 10) were permitted 10 h TIB (22:00-08:00) on all nights. Food and drink consumption were ad libitum and recorded daily. Compared to baseline, sleep-restricted participants increased daily caloric (+527 kcal) and saturated fat (+7 g) intake and decreased protein (-1.2% kcal) intake during both SR exposures; however, intake did not differ between exposures or recovery conditions. Similarly, although sleep-restricted participants exhibited substantial late-night caloric intake (671 kcal), such intake did not differ between exposures or recovery conditions. By contrast, control participants showed no changes in caloric intake across days. We found consistent caloric and macronutrient intake increases during two SR exposures despite varying intervening recovery nights. Thus, energy intake outcomes do not cumulatively increase with repeated restriction and are unaffected by recovery opportunities.",2020,"Compared to baseline, sleep-restricted participants increased daily caloric (+527 kcal) and saturated fat (+7 g) intake and decreased protein (-1.2% kcal) intake during both SR exposures; however, intake did not differ between exposures or recovery conditions.","['Healthy Adults', 'Healthy adults (33.9 ± 8.9y; 17 women, Body Mass Index: 24.8 ± 3.6) participated in a laboratory protocol']",['Sleep restriction (SR'],"['daily caloric (+527 kcal) and saturated fat (+7 g) intake and decreased protein', 'caloric intake', 'substantial late-night caloric intake']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517805', 'cui_str': '527'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]",10.0,0.0223244,"Compared to baseline, sleep-restricted participants increased daily caloric (+527 kcal) and saturated fat (+7 g) intake and decreased protein (-1.2% kcal) intake during both SR exposures; however, intake did not differ between exposures or recovery conditions.","[{'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Spaeth', 'Affiliation': 'Department of Kinesiology and Health, Division of Life Sciences, School of Arts and Sciences, Rutgers University, New Brunswick, NJ 08901, USA.'}, {'ForeName': 'Namni', 'Initials': 'N', 'LastName': 'Goel', 'Affiliation': 'Biological Rhythms Research Laboratory, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL 60612, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Dinges', 'Affiliation': 'Unit for Experimental Psychiatry, Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104, USA.'}]",Nutrients,['10.3390/nu12092694']
1604,32899447,Exercise Training and Vitamin C Supplementation Affects Ferritin mRNA in Leukocytes without Affecting Prooxidative/Antioxidative Balance in Elderly Women.,"Physical training and antioxidant supplementation may influence iron metabolism through reduced oxidative stress and subsequent lowering of mRNA levels of genes that are easily induced by this stress, including those responsible for iron homeostasis. Fifteen elderly women participated in our 12-week experiment, involving six weeks of training without supplementation and six weeks of training supported by oral supplementation of 1000 mg of vitamin C daily. The participants were divided into two groups ( n  = 7 in group 1 and  n  = 8 in group 2). In group 1, we applied vitamin C supplementation in the first six weeks of training, while in group 2 during the remaining six weeks of training. In both phases, the health-related training occurred three times per week. Training accompanied by vitamin C supplementation did not affect prooxidative/antioxidative balance but significantly decreased ferritin heavy chain  (FTH ) and ferritin light chain ( FTL ) mRNA in leukocytes (for  FTH  mRNA from 2^64.24 to 2^11.06,  p  = 0.03 in group 1 and from 2^60.54 to 2^16.03,  p  = 0.01 in group 2, for  FTL  mRNA from 2^20.22 to 2^4.53,  p  = 0.01 in group 2). We concluded that vitamin C supplementation might have caused a decrease in gene expression of two important antioxidative genes ( FTH, FTL)  and had no effect on plasma prooxidative/antioxidative balance.",2020,"Training accompanied by vitamin C supplementation did not affect prooxidative/antioxidative balance but significantly decreased ferritin heavy chain  (FTH ) and ferritin light chain ( FTL ) mRNA in leukocytes (for  FTH  mRNA from 2^64.24 to 2^11.06,  ","['Fifteen elderly women', 'Elderly Women']","['vitamin C supplementation', 'training without supplementation and six weeks of training supported by oral supplementation of 1000 mg of vitamin C daily', 'Exercise Training and Vitamin C Supplementation', 'Physical training and antioxidant supplementation']","['ferritin heavy chain  (FTH ) and ferritin light chain ( FTL ) mRNA in leukocytes', 'prooxidative/antioxidative balance', 'plasma prooxidative/antioxidative balance']","[{'cui': 'C0524338', 'cui_str': 'Elderly woman'}]","[{'cui': 'C4524018', 'cui_str': 'Vitamin C supplementation'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040608', 'cui_str': 'Training Support'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]","[{'cui': 'C0162905', 'cui_str': 'H-Ferritin'}, {'cui': 'C1855305', 'cui_str': 'Frank-Ter Haar syndrome'}, {'cui': 'C0391764', 'cui_str': 'L-Ferritin'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",15.0,0.0181971,"Training accompanied by vitamin C supplementation did not affect prooxidative/antioxidative balance but significantly decreased ferritin heavy chain  (FTH ) and ferritin light chain ( FTL ) mRNA in leukocytes (for  FTH  mRNA from 2^64.24 to 2^11.06,  ","[{'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Żychowska', 'Affiliation': 'Department of Sport, Faculty of Physical Education, Kazimierz Wielki University in Bydgoszcz, 85-064 Bydgoszcz, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Grzybkowska', 'Affiliation': 'Department of Biochemistry, Faculty of Physical Education, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Wiech', 'Affiliation': 'Department of Health Promotion, Faculty of Tourism and Recreation, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Urbański', 'Affiliation': 'Department of Biomechanics and Sports Engineering, Faculty of Physical Education, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Pilch', 'Affiliation': 'Department of Cosmetology, Faculty of Physiotherapy, University of Physical Education in Krakow, 31-571 Krakow, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Piotrowska', 'Affiliation': 'Department of Cosmetology, Faculty of Physiotherapy, University of Physical Education in Krakow, 31-571 Krakow, Poland.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Czerwińska-Ledwig', 'Affiliation': 'Department of Cosmetology, Faculty of Physiotherapy, University of Physical Education in Krakow, 31-571 Krakow, Poland.'}, {'ForeName': 'Jędrzej', 'Initials': 'J', 'LastName': 'Antosiewicz', 'Affiliation': 'Department of Bioenergetics and Exercise Physiology, Faculty of Health, Medical University of Gdansk, 80-210 Gdansk, Poland.'}]",International journal of molecular sciences,['10.3390/ijms21186469']
1605,32900508,"Intrathecal morphine and sleep apnoea severity in patients undergoing hip arthroplasty: a randomised, controlled, triple-blinded trial.","BACKGROUND


Intrathecal morphine prolongs analgesia after surgery, but has been implicated in postoperative respiratory depression or apnoeic episodes. However, this has not been investigated in a prospective trial using respiratory polygraphy. This randomised controlled triple-blinded trial tested the hypothesis that intrathecal morphine increases sleep apnoea severity, measured using respiratory polygraphy.
METHODS


Sixty subjects undergoing hip arthroplasty under spinal anaesthesia received either 15 mg isobaric bupivacaine 0.5% with 0.5 ml normal saline 0.9% (control group) or 15 mg isobaric bupivacaine 0.5% with 0.5 ml intrathecal morphine 100 μg (intrathecal morphine group). Respiratory polygraphy was performed before surgery and on the first and third postoperative nights. The primary outcome was the apnoea-hypopnoea index in the supine position (supine AHI) on the first postoperative night. Secondary outcomes included supine AHI on the third postoperative night, oxygen desaturation index (ODI), and ventilatory frequency during the first and third postoperative nights.
RESULTS


On the first postoperative night, mean (95% confidence interval) values for supine AHI were 20.6 (13.9-27.3) and 21.2 (12.4-30.0) events h -1  in the control and intrathecal morphine groups, respectively (P=0.90). There were no significant between-group differences for any of the secondary outcomes, except for a significantly higher central and mixed apnoea index preoperatively and significantly lower mean SpO 2  on the third postoperative night in the control group.
CONCLUSIONS


Intrathecal morphine did not increase sleep apnoea severity when measured using respiratory polygraphy. Of note, all patients had an increased number of apnoeic episodes on the third postoperative night.
CLINICAL TRIAL REGISTRATION


NCT02566226.",2020,"There were no significant between-group differences for any of the secondary outcomes, except for a significantly higher central and mixed apnoea index preoperatively and significantly lower mean SpO 2  on the third postoperative night in the control group.
","['Sixty subjects undergoing hip arthroplasty under spinal anaesthesia', 'patients undergoing hip arthroplasty']","['Intrathecal morphine', '15 mg isobaric bupivacaine 0.5% with 0.5 ml normal saline 0.9% (control group) or 15 mg isobaric bupivacaine 0.5% with 0.5 ml intrathecal morphine 100 μg (intrathecal morphine', 'intrathecal morphine', 'morphine']","['central and mixed apnoea index', 'sleep apnoea severity', 'supine AHI on the third postoperative night, oxygen desaturation index (ODI), and ventilatory frequency during the first and third postoperative nights', 'number of apnoeic episodes', 'apnoea-hypopnoea index in the supine position (supine AHI) on the first postoperative night']","[{'cui': 'C0186193', 'cui_str': 'Repair of hip'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}]",60.0,0.152898,"There were no significant between-group differences for any of the secondary outcomes, except for a significantly higher central and mixed apnoea index preoperatively and significantly lower mean SpO 2  on the third postoperative night in the control group.
","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Albrecht', 'Affiliation': 'Department of Anaesthesia, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland. Electronic address: eric.albrecht@chuv.ch.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Bayon', 'Affiliation': 'Center for Investigation and Research in Sleep, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Hirotsu', 'Affiliation': 'Center for Investigation and Research in Sleep, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Aboud', 'Initials': 'A', 'LastName': ""Al Ja'bari"", 'Affiliation': 'Department of Anaesthesia, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Heinzer', 'Affiliation': 'Center for Investigation and Research in Sleep, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.07.052']
1606,32901239,Fiberglass crowns versus preformed metal crowns in pulpotomized primary molars: a randomized controlled clinical trial.,"OBJECTIVE


To evaluate the clinical performance of the fiberglass ""Figaro"" crowns compared to preformed metal crowns (PMCs) in pulpotomized primary molars in children.
METHOD AND MATERIALS


This split-mouth controlled randomized clinical study was performed on ten childrens, aged from 4 to 6 years, who needed complete oral rehabilitation under general anesthesia and had one pair or two pairs of their primary molars requiring pulpotomy. After pulp therapy, the teeth were randomly assigned to Figaro or PMC crown groups. Modified United States Public Health Service (USPHS) criteria were used to evaluate crown retention, marginal integration, crown discoloration, secondary caries, and gingival status, at 3 and 6 months. The data were analyzed using the chi-square test with Monte Carlo (MC) correction and McNemar (McN) test at a significance level of .05.
RESULTS


Ten patients (three boys, 30%; seven girls, 70%) with a mean age of 4.65 ± 0.709 years participated in this study. At 3 months follow-up, there was no significant difference between the groups, but at 6 months follow-up, Figaro crowns showed significant changes from intact crown to either chipped or large loss, whereas all PMCs were found intact (χ2 = 14.545, P[MC] = 0.000). There was also significant deterioration in Figaro crowns' color after 6 months (χ2[McN] = 8.1, P = .004).
CONCLUSION


PMCs were more durable than Figaro crowns, which showed significant deterioration after the 6-month follow-up period.",2020,"At 3 months follow-up, there was no significant difference between the groups, but at 6 months follow-up, Figaro crowns showed significant changes from intact crown to either chipped or large loss, whereas all PMCs were found intact (χ2 = 14.545, P[MC] = 0.000).","['ten childrens, aged from 4 to 6 years, who needed complete oral rehabilitation under general anesthesia and had one pair or two pairs of their primary molars requiring pulpotomy', 'Ten patients (three boys, 30%; seven girls, 70%) with a mean age of 4.65 ± 0.709 years participated in this study', 'pulpotomized primary molars', 'pulpotomized primary molars in children']","['Fiberglass crowns versus preformed metal crowns', 'fiberglass ""Figaro"" crowns compared to preformed metal crowns (PMCs']",[],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C3544227', 'cui_str': 'Complete oral rehabilitation'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0060317', 'cui_str': 'Fiberglass'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0025552', 'cui_str': 'Metal'}]",[],,0.0365439,"At 3 months follow-up, there was no significant difference between the groups, but at 6 months follow-up, Figaro crowns showed significant changes from intact crown to either chipped or large loss, whereas all PMCs were found intact (χ2 = 14.545, P[MC] = 0.000).","[{'ForeName': 'Laila M', 'Initials': 'LM', 'LastName': 'El-Habashy', 'Affiliation': ''}, {'ForeName': 'Omar A', 'Initials': 'OA', 'LastName': 'El Meligy', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a45169']
1607,32901242,Evaluation of aromatherapy on success rate of inferior alveolar nerve block in teeth with irreversible pulpitis: a prospective randomized clinical trial.,"OBJECTIVE


This prospective, block randomized clinical trial was conducted to evaluate the effect of aromatherapy on the success rate of inferior alveolar nerve block (IANB) in teeth with irreversible pulpitis.
METHOD AND MATERIALS


In this clinical trial, 46 patients fulfilling the inclusion criteria were randomly divided into two equal groups: group I (n = 22) received IANB in a closed operatory without any fragrance, whereas group II (n = 24) received IANB in a separate closed operatory saturated with lavender fragrance using a candle warmer. The modified dental anxiety scale (MDAS) for anxiety and visual analog scale (VAS) for pain were recorded preoperatively as well as during access cavity preparation. For MDAS, a total score of more than 18 was considered as tremendously anxious or dental phobic. No or mild pain on VAS was considered as success. Data were analyzed using paired t test and independent sample t test. P < .05 was considered as statistically significant.
RESULTS


Difference in mean VAS (P = .749) and MDAS (P = 1.000) between both the groups was statistically nonsignificant. However there was a statistically significant difference in mean VAS (P = .000) and MDAS (P = .001) during access opening.
CONCLUSION


Lavender aromatherapy can be used successfully to alleviate dental anxiety as well as to increase the anesthetic success rate of IANB in teeth with irreversible pulpitis.",2020,"RESULTS


Difference in mean VAS (P = .749) and MDAS (P = 1.000) between both the groups was statistically nonsignificant.","['teeth with irreversible pulpitis', '46 patients fulfilling the inclusion criteria']","['IANB in a separate closed operatory saturated with lavender fragrance using a candle warmer', 'Lavender aromatherapy', 'aromatherapy', 'IANB in a closed operatory without any fragrance']","['success rate of inferior alveolar nerve block', 'mild pain', 'MDAS', 'success rate of inferior alveolar nerve block (IANB', 'modified dental anxiety scale (MDAS) for anxiety and visual analog scale (VAS) for pain', 'mean VAS']","[{'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0031000', 'cui_str': 'Perfume'}, {'cui': 'C1850568', 'cui_str': 'Nakajo-Nishimura syndrome'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}]","[{'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0278138', 'cui_str': 'Mild pain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",46.0,0.0564291,"RESULTS


Difference in mean VAS (P = .749) and MDAS (P = 1.000) between both the groups was statistically nonsignificant.","[{'ForeName': 'Ganesh R', 'Initials': 'GR', 'LastName': 'Jadhav', 'Affiliation': ''}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Mittal', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a45172']
1608,32901243,Bleaching sensitivity with a desensitizing in-office bleaching gel: a randomized double-blind clinical trial.,"OBJECTIVES


This split-mouth study assessed the bleaching sensitivity (risk and intensity) and color change after in-office bleaching using a desensitizing-containing (5% potassium nitrate) and a desensitizing-free 35% hydrogen peroxide gel. The null hypothesis was that there would be no differences between study groups regarding bleaching sensitivity.
METHOD AND MATERIALS


Sixty patients participated in this split-mouth study. The subjects received desensitizing-containing hydrogen peroxide in half of the maxillary arch, and the other half received a desensitizing-free hydrogen peroxide, defined by random sequence, in two dental bleaching sessions. The bleaching sensitivity was evaluated during bleaching and from 1 h to 48 h after each bleaching session using a visual analog scale and numeric rating scale; the McNemar test, the Wilcoxon signed-rank test, and the Student-Newman-Keuls test were used for statistical analysis. The color was measured at baseline and 30 days post-bleaching, evaluated with paired t tests (P = .05).
RESULTS


Statistically similar risks of bleaching sensitivity were observed (P = 1.000), but the intensity of bleaching sensitivity was lower (P < .011) on average by 1.32 visual analog scale units in the group bleached with the desensitizer-containing gel during up to 24 h assessment times. No statistical difference in color change was observed between groups (P > .321).
CONCLUSION


The incorporation of 5% potassium nitrate into in-office bleaching gels does not reduce the risk of bleaching sensitivity, but it reduces its intensity slightly without jeopardizing color change.",2020,"No statistical difference in color change was observed between groups (P > .321).
",['Sixty patients participated in this split-mouth study'],"['desensitizing-containing (5% potassium nitrate) and a desensitizing-free 35% hydrogen peroxide gel', 'desensitizing in-office bleaching gel', 'desensitizing-containing hydrogen peroxide', 'desensitizing-free hydrogen peroxide']","['intensity of bleaching sensitivity', 'color change', 'bleaching sensitivity', 'risk of bleaching sensitivity', 'bleaching sensitivity (risk and intensity) and color change', '\ufeffBleaching sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0071772', 'cui_str': 'potassium nitrate'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0442603', 'cui_str': 'Office'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0475330', 'cui_str': 'Color change'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",60.0,0.0834882,"No statistical difference in color change was observed between groups (P > .321).
","[{'ForeName': 'Bianca Medeiros', 'Initials': 'BM', 'LastName': 'Maran', 'Affiliation': ''}, {'ForeName': 'Laína', 'Initials': 'L', 'LastName': 'Vochikovski', 'Affiliation': ''}, {'ForeName': 'Diego Rafael de Andrade', 'Initials': 'DRA', 'LastName': 'Hortkoff', 'Affiliation': ''}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Stanislawczuk', 'Affiliation': ''}, {'ForeName': 'Alessandro D', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': ''}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a45173']
1609,32901695,In vitro remineralization of primary teeth with a mineralization-promoting peptide containing dental varnish.,"Mineralization-promoting peptides are attractive candidates for new remineralization systems. In previous studies, peptides have been applied as aqueous solutions, which is not a clinically relevant form.
OBJECTIVE


This study aims to investigate the efficiency of a mineralization-promoting peptide, applied in varnish, on remineralizing artificial caries on primary teeth.
METHODOLOGY


55 primary molars were collected. Specimens were immersed in a demineralizing solution for 7 days and then, divided into 7 groups: Baseline: No-remineralization, Placebo: Blank colophony, F: Colophony 5% fluoride, P: Colophony 10% peptide, P+F: Colophony 5% fluoride and 10% peptide, Embrace: Embrace™ varnish, Durashield: Durashield™ varnish. A mixture of 35% w/v colophony varnishes were prepared in ethanol and applied accordingly. Specimens were immersed in a remineralization solution for 4 weeks and it was evaluated using PLM and SEM. Lesion depth reduction was examined by one-way ANOVA.
RESULTS


There was no significant difference in mean lesion depths between baseline (147.04 ± 10.18 μm) and placebo groups (139.73 ± 14.92 μm), between F (120.95 ± 12.23 μm) and Durashield (113.47 ± 14.36 μm) groups and between P (81.79 ± 23.15 μm) and Embrace (90.26 ± 17.72 μm) groups. Lesion depth for the P+F group (66.95±10.59 μm) was significantly higher compared to all other groups. All groups contained samples with subsurface demineralized regions. Number of subsurface demineralized regions were higher in fluoride-containing groups.
CONCLUSIONS


We conclude that the mineralization-promoting peptide (MPP3) is effective in this in vitro study and the peptide shows benefits over fluoride as it yields less subsurface demineralized regions.",2020,Lesion depth for the P+F group (66.95±10.59 μm) was significantly higher compared to all other groups.,"['55 primary molars were collected', 'remineralizing artificial caries on primary teeth', 'primary teeth with a mineralization-promoting peptide containing dental varnish']","['placebo', 'Baseline: No-remineralization, Placebo: Blank colophony, F: Colophony 5% fluoride, P: Colophony 10% peptide, P+F: Colophony 5% fluoride and 10% peptide, Embrace: Embrace™ varnish, Durashield: Durashield™ varnish']","['Lesion depth reduction', 'mean lesion depths', 'Lesion depth', 'Number of subsurface demineralized regions']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0440150', 'cui_str': 'Dental varnish'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0073589', 'cui_str': 'rosin'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",55.0,0.0672111,Lesion depth for the P+F group (66.95±10.59 μm) was significantly higher compared to all other groups.,"[{'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Tulumbaci', 'Affiliation': 'Ankara Yildirim Beyazit University, School of Dentistry, Department of Pediatric Dentistry, Ankara, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Gungormus', 'Affiliation': 'Ankara Yildirim Beyazit University, School of Dentistry, Department of Basic Sciences, Ankara, Turkey.'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2020-0259']
1610,32901733,Split crest technique for implant treatment of agenesis of the upper lateral incisors: results of a randomized pilot histological and clinical study at 24-month follow-up.,"Agenesis of lateral incisors, besides the functional issues, represents a great esthetic drawback. The selection of an appropriate treatment is a complex decision, which should consider the stability of the clinical outcomes over time. The aim of the present study was a histological and clinical comparison of two-stage split crest technique (SCT), with bone chips alone or mixed with porcine bone in patients affected by unilateral and bilateral agenesis of the upper lateral incisors. Eleven patients were enrolled, and randomly assigned to receive a treatment with autologous bone chips (group 1) or autologous bone chips mixed 1:1 to porcine-derived xenogenic bone (group 2). After a 2-month healing period, implants were placed and biopsies harvested for histomorphometrical evaluation. Clinical assessment, according to ICOI PISA health scale, and radiographic marginal bone loss evaluation at 12- and 24-month follow-ups were conducted. The histomorphometry showed significantly greater new bone formation (p > 0.0229) in group 2. At 12- and 24-month follow-ups, all the evaluated implants, regardless of the group they were allocated, could be categorized as ""success"" in the ICOI Pisa Health Scale for Dental Implants, and did not show significant difference in crestal bone loss. To the best of our knowledge, these are the first histological and clinical outcomes indicating that the use of bone chips mixed 1:1 to porcine bone in SCT could be a promising technique for the rehabilitation of patients with agenesis of the upper lateral incisors, although studies with a larger number of patients and implants, and a longer follow up are needed.",2020,The histomorphometry showed significantly greater new bone formation (p > 0.0229) in group 2.,"['agenesis of the upper lateral incisors', 'Eleven patients', 'patients with agenesis of the upper lateral incisors', 'patients affected by unilateral and bilateral agenesis of the upper lateral incisors']","['autologous bone chips (group 1) or autologous bone chips mixed 1:1 to porcine-derived xenogenic bone', 'two-stage split crest technique (SCT), with bone chips alone or mixed with porcine bone', 'Split crest technique']","['crestal bone loss', 'ICOI PISA health scale, and radiographic marginal bone loss evaluation', 'new bone formation']","[{'cui': 'C0000846', 'cui_str': 'Agenesis'}, {'cui': 'C0227040', 'cui_str': 'Structure of maxillary right lateral incisor tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0206138', 'cui_str': 'CREST syndrome'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0334168', 'cui_str': 'New bone formation'}]",11.0,0.0304187,The histomorphometry showed significantly greater new bone formation (p > 0.0229) in group 2.,"[{'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Iezzi', 'Affiliation': 'University of Chieti-Pescara Department of Medical, Oral and Biotechnological Sciences, Chieti, Italy.'}, {'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Perrotti', 'Affiliation': 'University of Chieti-Pescara Department of Medical, Oral and Biotechnological Sciences, Chieti, Italy.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Piattelli', 'Affiliation': 'University of Chieti-Pescara Department of Medical, Oral and Biotechnological Sciences, Chieti, Italy.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': ""D'Arcangelo"", 'Affiliation': 'University of Chieti-Pescara Department of Medical, Oral and Biotechnological Sciences, Chieti, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Altieri', 'Affiliation': 'Sapienza University of Rome, Department of Oral and Maxillofacial Sciences, Rome, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cassetta', 'Affiliation': 'Sapienza University of Rome, Department of Oral and Maxillofacial Sciences, Rome, Italy.'}]",Brazilian oral research,['10.1590/1807-3107bor-2020.vol34.0118']
1611,32902561,"Perioperative Open-lung Approach, Regional Ventilation, and Lung Injury in Cardiac Surgery.","BACKGROUND


In the Protective Ventilation in Cardiac Surgery (PROVECS) randomized, controlled trial, an open-lung ventilation strategy did not improve postoperative respiratory outcomes after on-pump cardiac surgery. In this prespecified subanalysis, the authors aimed to assess the regional distribution of ventilation and plasma biomarkers of lung epithelial and endothelial injury produced by that strategy.
METHODS


Perioperative open-lung ventilation consisted of recruitment maneuvers, positive end-expiratory pressure (PEEP) = 8 cm H2O, and low-tidal volume ventilation including during cardiopulmonary bypass. Control ventilation strategy was a low-PEEP (2 cm H2O) low-tidal volume approach. Electrical impedance tomography was used serially throughout the perioperative period (n = 56) to compute the dorsal fraction of ventilation (defined as the ratio of dorsal tidal impedance variation to global tidal impedance variation). Lung injury was assessed serially using biomarkers of epithelial (soluble form of the receptor for advanced glycation end-products, sRAGE) and endothelial (angiopoietin-2) lung injury (n = 30).
RESULTS


Eighty-six patients (age = 64 ± 12 yr; EuroSCORE II = 1.65 ± 1.57%) undergoing elective on-pump cardiac surgery were studied. Induction of general anesthesia was associated with ventral redistribution of tidal volumes and higher dorsal fraction of ventilation in the open-lung than the control strategy (0.38 ± 0.07 vs. 0.30 ± 0.10; P = 0.004). No effect of the open-lung strategy on the dorsal fraction of ventilation was noted at the end of surgery after median sternotomy closure (open-lung = 0.37 ± 0.09 vs. control = 0.34 ± 0.11; P = 0.743) or in extubated patients at postoperative day 2 (open-lung = 0.63 ± 0.18 vs. control = 0.59 ± 0.11; P > 0.999). Open-lung ventilation was associated with increased intraoperative plasma sRAGE (7,677 ± 3,097 pg/ml vs. 6,125 ± 1,400 pg/ml; P = 0.037) and had no effect on angiopoietin-2 (P > 0.999).
CONCLUSIONS


In cardiac surgery patients, open-lung ventilation provided larger dorsal lung ventilation early during surgery without a maintained benefit as compared with controls at the end of surgery and postoperative day 2 and was associated with higher intraoperative plasma concentration of sRAGE suggesting lung overdistension.
EDITOR’S PERSPECTIVE


",2020,No effect of the open-lung strategy on the dorsal fraction of ventilation was noted at the end of surgery after median sternotomy closure (open-lung = 0.37 ± 0.09 vs. control = 0.34 ± 0.11; P = 0.743) or in extubated patients at postoperative day 2 (open-lung = 0.63 ± 0.18 vs. control = 0.59 ± 0.11; P > 0.999).,"['cardiac surgery patients', 'Eighty-six patients (age = 64 ± 12 yr; EuroSCORE II = 1.65 ± 1.57%) undergoing elective on-pump cardiac surgery']","['open-lung ventilation', 'lung ventilation consisted of recruitment maneuvers, positive end-expiratory pressure (PEEP) = 8 cm H2O, and low-tidal volume ventilation including during cardiopulmonary bypass']","['postoperative respiratory outcomes', 'dorsal lung ventilation', 'dorsal fraction of ventilation', 'intraoperative plasma sRAGE', 'ventral redistribution of tidal volumes and higher dorsal fraction of ventilation']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3164744', 'cui_str': 'European system for cardiac operative risk evaluation'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0182537', 'cui_str': 'Pump'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0332620', 'cui_str': 'Redistribution'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0821825,No effect of the open-lung strategy on the dorsal fraction of ventilation was noted at the end of surgery after median sternotomy closure (open-lung = 0.37 ± 0.09 vs. control = 0.34 ± 0.11; P = 0.743) or in extubated patients at postoperative day 2 (open-lung = 0.63 ± 0.18 vs. control = 0.59 ± 0.11; P > 0.999).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lagier', 'Affiliation': ''}, {'ForeName': 'Lionel J', 'Initials': 'LJ', 'LastName': 'Velly', 'Affiliation': ''}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Guinard', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bruder', 'Affiliation': ''}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Guidon', 'Affiliation': ''}, {'ForeName': 'Marcos F', 'Initials': 'MF', 'LastName': 'Vidal Melo', 'Affiliation': ''}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Alessi', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003539']
1612,32897809,Maternal Support Is Protective Against Suicidal Ideation Among a Diverse Cohort of Young Transgender Women.,"Purpose:  We assessed if young transgender women (YTW) with parents who are supportive of their transgender identity had lower odds of having suicidal ideation compared with YTW with unsupportive parents.  Methods:  This study analyzed baseline findings from a diverse sample of 297 sexually active, YTW 16-29 years of age who were enrolled in Project LifeSkills, a randomized controlled HIV prevention intervention efficacy trial in Chicago and Boston, between 2012 and 2015. Bivariate and multivariable logistic regression were used to assess if parental support was associated with a decreased odds of suicidal ideation.  Results:  Nearly one-fifth (18.9%) of YTW reported suicidal ideation at baseline. In our adjusted multivariable model, YTW with supportive mothers had 0.37 (95% confidence interval = 0.15-0.90) times the odds of having suicidal ideation compared with YTW with unsupportive mothers.  Conclusion:  This study found that the odds of suicidal ideation were lower among YTW who had mothers who were supportive of their transgender identity. Our results suggest that parent-focused interventions to improve the relationships between YTW and their parents may lower the odds of YTW having suicidal ideation. Clinical Trial Registration Identifier: NCT01575938.",2020,This study found that the odds of suicidal ideation were lower among YTW who had mothers who were supportive of their transgender identity.,"['diverse sample of 297 sexually active, YTW 16-29 years of age who were enrolled in Project LifeSkills, a randomized controlled HIV prevention intervention efficacy trial in Chicago and Boston, between 2012 and 2015', 'young transgender women (YTW) with parents who are supportive of their transgender identity had lower odds of having suicidal ideation compared with YTW with unsupportive parents']",[],['suicidal ideation'],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],"[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]",297.0,0.104996,This study found that the odds of suicidal ideation were lower among YTW who had mothers who were supportive of their transgender identity.,"[{'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Arjee', 'Initials': 'A', 'LastName': 'Restar', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Goedel', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Adedotun', 'Initials': 'A', 'LastName': 'Ogunbajo', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Biello', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Operario', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kuhns', 'Affiliation': 'Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Sari L', 'Initials': 'SL', 'LastName': 'Reisner', 'Affiliation': ""Division of General Pediatrics, Boston Children's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Mimiaga', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}]",LGBT health,['10.1089/lgbt.2020.0219']
1613,32914010,Genomic Instability and  TP53  Genomic Alterations Associate With Poor Antiproliferative Response and Intrinsic Resistance to Aromatase Inhibitor Treatment.,"PURPOSE


Although aromatase inhibitor (AI) treatment is effective in estrogen receptor-positive postmenopausal breast cancer, resistance is common and incompletely explained. Genomic instability, as measured by somatic copy number alterations (SCNAs), is important in breast cancer development and prognosis. SCNAs to specific genes may drive intrinsic resistance, or high genomic instability may drive tumor heterogeneity, which allows differential response across tumors and surviving cells to evolve resistance to treatment rapidly. We therefore evaluated the relationship between SCNAs and intrinsic resistance to treatment as measured by a poor antiproliferative response.
PATIENTS AND METHODS


SCNAs were determined by single nucleotide polymorphism array in baseline and surgery core-cuts from 73 postmenopausal patients randomly assigned to receive 2 weeks of preoperative AI or no AI in the Perioperative Endocrine Therapy-Individualizing Care (POETIC) trial. Fifty-six samples from the AI group included 28 poor responders (PrRs, less than 60% reduction in protein encoded by the  MKI67  gene [Ki-67]) and 28 good responders (GdRs, greater than 75% reduction in Ki-67). Exome sequencing was available for 72 pairs of samples.
RESULTS


Genomic instability correlated with Ki-67 expression at both baseline ( P  < .001) and surgery ( P  < .001) and was higher in PrRs ( P  = .048). The SCNA with the largest difference between GdRs and PrRs was loss of heterozygosity observed at 17p (false discovery rate, 0.08), which includes  TP53.  Nine of 28 PrRs had loss of wild-type  TP53  as a result of mutations and loss of heterozygosity compared with three of 28 GdRs. In PrRs, somatic alterations of  TP53  were associated with higher genomic instability, higher baseline Ki-67, and greater resistance to AI treatment compared with wild-type  TP53 .
CONCLUSION


We observed that primary tumors with high genomic instability have an intrinsic resistance to AI treatment and do not require additional evolution to develop resistance to estrogen deprivation therapy.",2019,"RESULTS


Genomic instability correlated with Ki-67 expression at both baseline ( P  < .001) and surgery ( P  < .001) and was higher in PrRs ( P  = .048).",['SCNAs were determined by single nucleotide polymorphism array in baseline and surgery core-cuts from 73 postmenopausal patients'],"['preoperative AI or no AI in the Perioperative Endocrine Therapy-Individualizing Care', 'aromatase inhibitor (AI) treatment']","['Ki-67 expression', 'heterozygosity']","[{'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0019425', 'cui_str': 'Heterozygote'}]",73.0,0.0322576,"RESULTS


Genomic instability correlated with Ki-67 expression at both baseline ( P  < .001) and surgery ( P  < .001) and was higher in PrRs ( P  = .048).","[{'ForeName': 'Eugene F', 'Initials': 'EF', 'LastName': 'Schuster', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Gellert', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Corrinne V', 'Initials': 'CV', 'LastName': 'Segal', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'López-Knowles', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Buus', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Maggie Chon U', 'Initials': 'MCU', 'LastName': 'Cheang', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Morden', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Robertson', 'Affiliation': 'University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Bliss', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Smith', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Dowsett', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JCO precision oncology,['10.1200/PO.18.00286']
1614,32915027,Mindfulness-oriented recovery enhancement reduces opioid dose in primary care by strengthening autonomic regulation during meditation.,"The current opioid crisis was fueled by escalation of opioid dosing among patients with chronic pain. Yet, there are few evidence-based psychological interventions for opioid dose reduction among chronic pain patients treated with long-term opioid analgesics. Mindfulness-Oriented Recovery Enhancement (MORE), which was designed to target mechanisms underpinning chronic pain and opioid misuse, has shown promising results in 2 randomized clinical trials (RCTs) and could facilitate opioid sparing and tapering by bolstering self-regulation. Here we tested this hypothesis with secondary analyses of data from a Stage 2 RCT. Chronic pain patients (N = 95) on long-term opioid therapy were randomized to 8 weeks of MORE or a support group (SG) control delivered in primary care. Opioid dose was assessed with the Timeline Followback through 3-month follow-up. Heart rate variability (HRV) during mindfulness meditation was quantified as an indicator of self-regulatory capacity. Participants in MORE evidenced a greater decrease in opioid dosing (a 32% decrease) by follow-up than did the SG, F(2, 129.77) = 5.35, p = .006, d = 1.07. MORE was associated with a significantly greater increase in HRV during meditation than was the SG. Meditation-induced change in HRV partially mediated the effect of MORE on opioid dose reduction (p = .034). MORE may boost self-regulatory strength via mindfulness and thereby facilitate self-control over opioid use, leading to opioid dose reduction in people with chronic pain. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Meditation-induced change in HRV partially mediated the effect of MORE on opioid dose reduction (p = .034).,"['people with chronic pain', 'chronic pain patients treated with long-term opioid analgesics', 'Chronic pain patients (N = 95) on long-term opioid therapy', 'patients with chronic pain']","['MORE or a support group (SG) control delivered in primary care', 'Mindfulness-Oriented Recovery Enhancement (MORE']","['Heart rate variability (HRV', 'HRV']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0780555,Meditation-induced change in HRV partially mediated the effect of MORE on opioid dose reduction (p = .034).,"[{'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Garland', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Hudak', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah.'}, {'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Hanley', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah.'}]",The American psychologist,['10.1037/amp0000638']
1615,32916151,Synergistic effects of fructose and glucose on lipoprotein risk factors for cardiovascular disease in young adults.,"BACKGROUND


Fructose consumption increases risk factors for cardiometabolic disease. It is assumed that the effects of free sugars on risk factors are less potent because they contain less fructose. We compared the effects of consuming fructose, glucose or their combination, high fructose corn syrup (HFCS), on cardiometabolic risk factors.
METHODS


Adults (18-40 years; BMI 18-35 kg/m 2 ) participated in a parallel, double-blinded dietary intervention during which beverages sweetened with aspartame, glucose (25% of energy requirements (ereq)), fructose or HFCS (25% and 17.5% ereq) were consumed for two weeks. Groups were matched for sex, baseline BMI and plasma lipid/lipoprotein concentrations. 24-h serial blood samples were collected at baseline and at the end of intervention. Primary outcomes were 24-h triglyceride AUC, LDL-cholesterol (C), and apolipoprotein (apo)B. Interactions between fructose and glucose were assessed post hoc.
FINDINGS


145 subjects (26.0 ± 5.8 years; body mass index 25.0 ± 3.7 kg/m 2 ) completed the study. As expected, the increase of 24-h triglycerides compared with aspartame was highest during fructose consumption (25%: 6.66 mmol/Lx24h 95% CI [1.90 to 11.63], P = 0.0013 versus aspartame), intermediate during HFCS consumption (25%: 4.68 mmol/Lx24h 95% CI [-0.18 to 9.55], P = 0.066 versus aspartame) and lowest during glucose consumption. In contrast, the increase of LDL-C was highest during HFCS consumption (25%: 0.46 mmol/L 95% CI [0.16 to 0.77], P = 0.0002 versus aspartame) and intermediate during fructose consumption (25%: 0.33 mmol/L 95% CI [0.03 to 0.63], P = 0.023 versus aspartame), as was the increase of apoB (HFCS-25%: 0.108 g/L 95%CI [0.032 to 0.184], P = 0.001; fructose 25%: 0.072 g/L 95%CI [-0.004 to 0.148], P = 0.074 versus aspartame). The post hoc analyses showed significant interactive effects of fructose*glucose on LDL-C and apoB (both P < 0.01), but not on 24-h triglyceride (P = 0.340).
CONCLUSION


A significant interaction between fructose and glucose contributed to increases of lipoprotein risk factors when the two monosaccharides were co-ingested as HFCS. Thus, the effects of HFCS on lipoprotein risks factors are not solely mediated by the fructose content and it cannot be assumed that glucose is a benign component of HFCS. Our findings suggest that HFCS may be as harmful as isocaloric amounts of pure fructose and provide further support for the urgency to implement strategies to limit free sugar consumption.",2020,A significant interaction between fructose and glucose contributed to increases of lipoprotein risk factors when the two monosaccharides were co-ingested as HFCS.,"['young adults', 'Adults (18-40\u202fyears; BMI 18-35\u202fkg/m 2 ) participated in a']","['consuming fructose, glucose or their combination, high fructose corn syrup (HFCS', 'fructose and glucose', 'Fructose consumption', 'parallel, double-blinded dietary intervention during which beverages sweetened with aspartame, glucose (25% of energy requirements (ereq)), fructose or HFCS', 'HFCS']","['lipoprotein risk factors', '24-h triglycerides', 'LDL-C and apoB', '24-h triglyceride', '24-h serial blood samples', 'LDL-C', '24-h triglyceride AUC, LDL-cholesterol (C), and apolipoprotein (apo)B. Interactions between fructose and glucose']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C2981326', 'cui_str': 'High Fructose Corn Syrup'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0003999', 'cui_str': 'Aspartame'}, {'cui': 'C0489460', 'cui_str': 'Energy requirement'}]","[{'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",145.0,0.0811716,A significant interaction between fructose and glucose contributed to increases of lipoprotein risk factors when the two monosaccharides were co-ingested as HFCS.,"[{'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Hieronimus', 'Affiliation': 'Max Rubner-Institut, Institute of Child Nutrition, Karlsruhe, Germany; Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America. Electronic address: bettina.hieronimus@mri.bund.de.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Medici', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Bremer', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of California, Davis, CA, United States of America; Pediatric Growth and Nutrition Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, United States of America.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Lee', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Marinelle V', 'Initials': 'MV', 'LastName': 'Nunez', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Desiree M', 'Initials': 'DM', 'LastName': 'Sigala', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America; Department of Nutrition, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Keim', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, United States of America; United States Department of Agriculture, Western Human Nutrition Research Center, Davis, CA, United States of America.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Havel', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America; Department of Nutrition, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Kimber L', 'Initials': 'KL', 'LastName': 'Stanhope', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154356']
1616,32919056,Exercise-induced changes in brain activity during memory encoding and retrieval after long-term bed rest.,"Episodic memory depends decisively on the hippocampus and the parahippocampal gyrus, brain structures that are also prone to exercise-induced neuroplasticity and cognitive improvement. We conducted a randomized controlled trial to investigate the effects of a high-intensity exercise program in twenty-two men resting in bed for 60 days on episodic memory and its neuronal basis. All participants were exposed to 60 days of uninterrupted bed rest. Eleven participants were additionally assigned to a high-intensity interval training that was performed five to six times weekly for 60 days. Episodic memory and its neural basis were determined four days prior to and on the 58th day of bed rest using functional magnetic resonance imaging (fMRI). We found increased BOLD signal in the left hippocampus and parahippocampal gyrus in the non-exercising group compared to the exercising bed rest group whereas the mnemonic performance did not differ significantly. These findings indicate a higher neuronal efficiency in the training group during memory encoding and retrieval and may suggest a dysfunctional mechanism in the non-exercising bed rest group induced by two months of physical inactivity. Our results provide further support for the modulating effects of physical exercise and adverse implications of a sedentary lifestyle and bedridden patients.",2020,We found increased BOLD signal in the left hippocampus and parahippocampal gyrus in the non-exercising group compared to the exercising bed rest group whereas the mnemonic performance did not differ significantly.,"['Eleven participants', 'twenty-two sedentary men resting in bed for 60 days on episodic memory and its neuronal basis']",['high-intensity exercise program'],"['BOLD signal', 'neuronal efficiency', 'brain activity']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",22.0,0.0382575,We found increased BOLD signal in the left hippocampus and parahippocampal gyrus in the non-exercising group compared to the exercising bed rest group whereas the mnemonic performance did not differ significantly.,"[{'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Friedl-Werner', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany; Université de Normandie, INSERM U 1075 COMETE, 14000 Caen, France.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Brauns', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany.'}, {'ForeName': 'Hanns-Christian', 'Initials': 'HC', 'LastName': 'Gunga', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kühn', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany; Max-Planck-Institute for Human Development, Lise Meitner Group for Environmental Neuroscience, 14195 Berlin, Germany.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Stahn', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany; Unit of Experimental Psychiatry, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA 19104, USA. Electronic address: astahn@pennmedicine.upenn.edu.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117359']
1617,32919092,"Training effects of attention and EF strategy-based training ""Nexxo"" in school-age students.","Given the importance of attention and executive functions in children's behavior, programs directed to improve these processes are of interest. Nexxo-training combines the use of the Nexxo touchscreen application (go/no-go and stop signal tasks) with procedural metacognitive strategies. The present paper reports a test of Nexxo's impact on children aged 6-7 and 8-9 years. We conducted a randomized active-controlled trial involving 108 typically-developing children: 1st grade (N = 61, M = 6.46 years, SD = 0.35) and 3rd grade (N = 47, M = 8.5 years, SD = 0.27), randomly assigned to: (1) experimental, (2) active-control, or (3) passive-control groups. A 2-month follow-up was carried out after the intervention. The 3rd grade experimental group displayed a significant reduction in attentional problems at follow-up compared to both control groups. Executive Function problems were also reduced at follow-up in the experimental group. Participants in this group improved in Supervision (self-monitoring) at post-intervention and follow-up compared to passive-controls. Although group effect was not significant at t1, it was significant at post measures in experimental group compared to passive-controls. Nexxo-training revealed a trend-level improvement in attention and executive functions for children in the 3rd grade.",2020,Participants in this group improved in Supervision (self-monitoring) at post-intervention and follow-up compared to passive-controls.,"['school-age students', '108 typically-developing children: 1st grade (N\xa0=\xa061, M\xa0=\xa06.46\xa0years, SD\xa0=\xa00.35) and 3rd grade (N\xa0=\xa047, M\xa0=\xa08.5\xa0years, SD\xa0=\xa00.27', 'children aged 6-7 and 8-9\xa0years']","['attention and EF strategy-based training ""Nexxo', 'active-control, or (3) passive-control groups', 'Nexxo-training', 'Nexxo touchscreen application (go/no-go and stop signal tasks) with procedural metacognitive strategies']","['attention and executive functions', 'Executive Function problems', 'attentional problems']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C4517877', 'cui_str': '8.5'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",108.0,0.0178247,Participants in this group improved in Supervision (self-monitoring) at post-intervention and follow-up compared to passive-controls.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rossignoli-Palomeque', 'Affiliation': 'Department of Basic Psychology II, Complutense University of Madrid, Madrid, Spain. Electronic address: teresa.rossignoli@ucm.es.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Perez-Hernandez', 'Affiliation': 'Department of Development and Educational Psychology, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'González-Marqués', 'Affiliation': 'Department of Basic Psychology II, Complutense University of Madrid, Madrid, Spain.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103174']
1618,32920297,Postprandial factor VII activation does not increase plasma concentrations of prothrombin fragment 1 + 2 in patients with morbid obesity.,"INTRODUCTION


Increased postprandial factor VII activation is observed after high-fat meals, but is not accompanied by thrombin formation in normal weight individuals. Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals. We therefore compared postprandial effects of high-fat meals and low-fat meals on biomarkers of coagulation activation in patients with morbid obesity and investigated whether the response was associated with the gut bacteria composition.
MATERIALS AND METHODS


A controlled cross-over study was conducted in obese patients (15 women, 5 men, mean BMI = 44.1 kg/m 2 ), where high-fat meals (67 E% fat) and low-fat meals (16 E% fat) were served at 8:15 and 10:00 in a random order on two study days within one week. Blood samples were collected at 08:00 (fasting), 12:00, and 14:00 and analysed for triglycerides, activated FVII (FVIIa), TF, FVIIa-antithrombin (FVIIa-AT), prothrombin fragment 1 + 2 (F1+2), and TF pathway inhibitor (TFPI). The gut bacteria composition, measured as gram-negative bacteria and diversity, was analysed in faecal samples.
RESULTS


Triglycerides, FVIIa, and FVIIa-AT increased significantly after high-fat meals, whereas F1 + 2 decreased equally and significantly over time after both meals. There were no significant changes in TF and TFPI over time. The postprandial changes in F1 + 2 and TFPI after high-fat meals were negatively correlated with diversity.
CONCLUSIONS


Increased postprandial FVIIa is not accompanied by thrombin formation four hours after high-fat meals in patients with morbid obesity, possibly due to FVIIa-inhibition by AT.",2020,"Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals.","['patients with morbid obesity', 'obese patients (15 women, 5 men, mean BMI\xa0', 'normal weight individuals']",['high-fat meals and low-fat meals'],"['Triglycerides, FVIIa, and FVIIa-AT', 'triglycerides, activated FVII (FVIIa), TF, FVIIa-antithrombin (FVIIa-AT), prothrombin fragment 1\xa0+\xa02 (F1+2), and TF pathway inhibitor (TFPI', 'Blood samples', 'postprandial changes', 'gut bacteria composition', 'TF and TFPI', 'thrombin formation', 'circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0040048', 'cui_str': 'Thromboplastin'}, {'cui': 'C0072436', 'cui_str': 'Prothrombin fragment 1.2'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0164707', 'cui_str': 'Tissue factor pathway inhibitor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]",,0.0190304,"Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals.","[{'ForeName': 'Line Espenhain', 'Initials': 'LE', 'LastName': 'Landgrebe', 'Affiliation': 'Unit for Thrombosis Research, Department of Clinical Biochemistry, University Hospital of Southern Denmark, Esbjerg, Denmark; Department of Regional Health Research, University of Southern Denmark, Denmark; OPEN, Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark. Electronic address: Line.Espenhain.Landgrebe@rsyd.dk.'}, {'ForeName': 'Claus Bogh', 'Initials': 'CB', 'LastName': 'Juhl', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Denmark; Department of Medicine, Section of Endocrinology, University Hospital of Southern Denmark, Esbjerg, Denmark; Steno Diabetes Center Odense, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Denmark; Focused Research Unit for Molecular Diagnostic and Clinical Research, University Hospital of Southern Denmark, Aabenraa, Denmark; Institute of Molecular Medicine, University of Southern Denmark, Denmark.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Moitinho-Silva', 'Affiliation': 'Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany; Department of Dermatology, Venereology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Bang', 'Affiliation': 'Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany.'}, {'ForeName': 'Else Marie', 'Initials': 'EM', 'LastName': 'Bladbjerg', 'Affiliation': 'Unit for Thrombosis Research, Department of Clinical Biochemistry, University Hospital of Southern Denmark, Esbjerg, Denmark; Department of Regional Health Research, University of Southern Denmark, Denmark.'}]",Thrombosis research,['10.1016/j.thromres.2020.08.044']
1619,32920321,Effects of cerebellar transcranial magnetic stimulation on ataxias: A randomized trial.,"INTRODUCTION


Cerebellar ataxia remains a neurological symptom orphan of treatment interventions, despite being prevalent and incapacitating. We aimed to study, in a double-blind design, whether cerebellar modulation could improve ataxia.
METHODS


We included patients with diagnosis of spinocerebellar ataxia type 3, multiple systems atrophy cerebellar type, or post-lesion ataxia. Patients received five sessions each of sham and active cerebellar 1 Hz deep repetitive transcranial magnetic stimulation in randomized order. Our primary outcome was the decrease in the Scale for the Assessment and Rating of Ataxia when comparing phases (active x sham). Secondary outcomes measures included the International Cooperative Ataxia Rating Scale, and other motor, cognitive, and quality of life scales. This study was registered at clinicaltrials.gov (protocol NCT03213106).
RESULTS


Twenty-four patients aged 29-74 years were included in our trial. After active stimulation, the Scale for the Assessment and Rating of Ataxia score was significantly lower than the score after sham stimulation [median (interquartile range) of 10.2 (6.2, 16.2) versus 12.8 (9.6, 17.8); p = 0.002]. The International Cooperative Ataxia Rating Scale score also improved after active stimulation versus sham [median (interquartile range) of 29.0 (21.0, 43.5) versus 32.8 (22.0, 47.0); p = 0.005]. Other secondary outcomes were not significantly modified by stimulation. No patient presented severe side effects, and nine presented mild and self-limited symptoms.
CONCLUSIONS


Our protocol was safe and well-tolerated. These findings suggest that cerebellar modulation may improve ataxic symptom and provide reassurance about safety for clinical practice.",2020,"After active stimulation, the Scale for the Assessment and Rating of Ataxia score was significantly lower than the score after sham stimulation [median (interquartile range) of 10.2 (6.2, 16.2) versus 12.8 (9.6, 17.8); p = 0.002].","['ataxias', 'Twenty-four patients aged 29-74 years', 'patients with diagnosis of spinocerebellar ataxia type 3, multiple systems atrophy cerebellar type, or post-lesion ataxia']","['Hz deep repetitive transcranial magnetic stimulation', 'cerebellar transcranial magnetic stimulation']","['International Cooperative Ataxia Rating Scale score', 'ataxia', 'ataxic symptom', 'severe side effects', 'International Cooperative Ataxia Rating Scale, and other motor, cognitive, and quality of life scales', 'safe and well-tolerated', 'Scale for the Assessment and Rating of Ataxia', 'Scale for the Assessment and Rating of Ataxia score']","[{'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024408', 'cui_str': 'Azorean disease'}, {'cui': 'C0393571', 'cui_str': 'Multiple system atrophy'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C4760996', 'cui_str': 'International cooperative ataxia rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C0234366', 'cui_str': 'Ataxic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C4760258', 'cui_str': 'Ataxia assessment scale'}]",24.0,0.653213,"After active stimulation, the Scale for the Assessment and Rating of Ataxia score was significantly lower than the score after sham stimulation [median (interquartile range) of 10.2 (6.2, 16.2) versus 12.8 (9.6, 17.8); p = 0.002].","[{'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'França', 'Affiliation': 'Movement Disorders Center, LIM 62, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'de Andrade', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Valquíria', 'Initials': 'V', 'LastName': 'Silva', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Galhardoni', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Egberto R', 'Initials': 'ER', 'LastName': 'Barbosa', 'Affiliation': 'Movement Disorders Center, LIM 62, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Manoel J', 'Initials': 'MJ', 'LastName': 'Teixeira', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil; Functional Neurosurgery Division, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rubens G', 'Initials': 'RG', 'LastName': 'Cury', 'Affiliation': 'Movement Disorders Center, LIM 62, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil; Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil. Electronic address: rubens_cury@usp.br.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.09.001']
1620,32920476,A brief cognitive behavioural intervention is cost-effective for primary care patients with medically unexplained physical symptoms compared to usual care.,"OBJECTIVE


To assess the cost-effectiveness of a brief cognitive behavioural intervention for patients with medically unexplained physical symptoms (MUPS) provided by a mental health nurse practitioner (MHNP) in primary care in comparison with usual care.
METHODS


We performed an economic evaluation from a societal perspective alongside a cluster randomised controlled trial with 12 months follow-up. The primary outcome was quality-adjusted life-years (QALYs). Secondary outcomes were the RAND-36 physical component summary score (PCS), somatic symptom severity (Patient Health Questionnaire (PHQ-15), and anxiety and depression symptoms (Hospital Anxiety and Depression Scale (HADS)). Missing data were imputed using multiple imputation. We used non-parametric bootstrapping to estimate statistical uncertainty. The bootstrapped cost-effect pairs were used to estimate cost-effectiveness planes and cost-effectiveness acceptability curves.
RESULTS


Mean total costs in the intervention group were significantly lower than in the usual care group (mean difference - 2300€, 95% CI -3257 to -134). The mean difference in QALYs was 0.01 (95% CI -0.01 to 0.04), in PCS 2.46 (95% CI 1.44 to 3.47), in PHQ-15 -0.26 (95% CI -0.81 to 0.28), and in HADS -0.07 (-0.81 to 0.67). At a willingness to pay of 0 € per additional unit of effect, the probability of the intervention being cost-effective was 0.93 for QALYs and 0.92 for PCS, PHQ-15 and HADS scores.
CONCLUSION


Our intervention is cost-effective compared to usual care for patients with MUPS. Implementation of the intervention has the potential to result in a significant decline in costs. However, large scale implementation would require increased deployment of MHNPs.",2020,"Mean total costs in the intervention group were significantly lower than in the usual care group (mean difference - 2300€, 95% CI -3257 to -134).","['patients with MUPS', 'patients with medically unexplained physical symptoms (MUPS) provided by a mental health nurse practitioner (MHNP) in primary care in comparison with usual care', 'primary care patients with medically unexplained physical symptoms compared to usual care']",['cognitive behavioural intervention'],"['cost-effectiveness', 'quality-adjusted life-years (QALYs', 'RAND-36 physical component summary score (PCS), somatic symptom severity (Patient Health Questionnaire (PHQ-15), and anxiety and depression symptoms (Hospital Anxiety and Depression Scale (HADS', 'cost-effectiveness planes and cost-effectiveness acceptability curves', 'Mean total costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033870', 'cui_str': 'Nursing, Psychiatric'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.101801,"Mean total costs in the intervention group were significantly lower than in the usual care group (mean difference - 2300€, 95% CI -3257 to -134).","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Sitnikova', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands. Electronic address: e.sitnikova@amsterdamumc.nl.'}, {'ForeName': 'Aureliano P', 'Initials': 'AP', 'LastName': 'Finch', 'Affiliation': 'EuroQol Research Foundation, Marten Meesweg 107, 3068 AV Rotterdam, the Netherlands.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': 'Leone', 'Affiliation': 'Trimbos Institute, Da Costakade 45, 3521 VS Utrecht, the Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Vrije Universiteit Amsterdam, De Boelelaan 1105, 1081 HV Amsterdam, the Netherlands.'}, {'ForeName': 'Harm W J', 'Initials': 'HWJ', 'LastName': 'van Marwijk', 'Affiliation': 'Brighton and Sussex Medical School, 94 N - S Rd, Falmer, Brighton BN1 9PX, United Kingdom.'}, {'ForeName': 'Henriëtte E', 'Initials': 'HE', 'LastName': 'van der Horst', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'van der Wouden', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110217']
1621,32920492,A randomized-controlled trial of blonanserin and olanzapine as adjunct to antipsychotics in the treatment of patients with schizophrenia and dopamine supersensitivity psychosis: The ROADS study.,"Dopamine supersensitivity psychosis (DSP) is a key factor contributing to the development of antipsychotic treatment-resistant schizophrenia. We examined the efficacy and safety of blonanserin (BNS) and olanzapine (OLZ) as adjuncts to prior antipsychotic treatment in patients with schizophrenia and DSP in a 24-week, multicenter (17 sites), randomized, rater-blinded study with two parallel groups (BNS and OLZ add-on treatments) in patients with schizophrenia and DSP: the ROADS Study. The primary outcome was the change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 24. Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses. The 61 assessed patients were allocated into a BNS group (n = 26) and an OLZ group (n = 29). The PANSS total scores were reduced in both groups (mean ± SD: -14.8 ± 24.0, p = 0.0042; -10.5 ± 12.9, p = 0.0003; respectively) with no significant between-group difference (mean, -4.3, 95 %CI 15.1-6.4, p = 0.42). The BNS group showed significant reductions from week 4; the OLZ group showed significant reductions from week 8. The ESRS scores were reduced in the BNS group and the others were reduced in both groups. The antipsychotic monotherapy rates at the endpoint were 26.3 % (n = 6) for BNS and 23.8 % (n = 5) for OLZ. The concomitant antipsychotic doses were reduced in both groups with good tolerability. Our results suggest that augmentations with BNS and OLZ are antipsychotic treatment options for DSP patients, and BNS may be favorable for DSP based on the relatively quick responses to BNS observed herein.",2020,"Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses.","['patients with schizophrenia and dopamine supersensitivity psychosis', 'Dopamine supersensitivity psychosis (DSP', 'patients with schizophrenia and DSP in a 24-week, multicenter (17 sites', 'patients with schizophrenia and DSP']","['BNS', 'OLZ', 'antipsychotics', 'blonanserin (BNS) and olanzapine (OLZ', 'blonanserin and olanzapine']","['PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses', 'antipsychotic monotherapy rates', 'change in the Positive and Negative Syndrome Scale (PANSS) total score', 'ESRS scores', 'PANSS total scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0287983', 'cui_str': 'blonanserin'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0187611,"Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses.","[{'ForeName': 'Tomihisa', 'Initials': 'T', 'LastName': 'Niitsu', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan. Electronic address: niitsu@chiba-u.jp.'}, {'ForeName': 'Tatsuki', 'Initials': 'T', 'LastName': 'Hata', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Fujita Hospital, Sosa, Chiba, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Nishimoto', 'Affiliation': 'Soshu Hospital, Atsugi, Kanagawa, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Hosoda', 'Affiliation': 'Fujita Hospital, Sosa, Chiba, Japan; Child Psychiatry, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kimura', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Oda', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Mobara Mental Hospital, Mobara, Chiba, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Takase', 'Affiliation': 'Mobara Mental Hospital, Mobara, Chiba, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Seki', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Chiba Hospital, Funabashi, Chiba, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Fujita', 'Affiliation': 'Okehazama Hospital Fujita Kokoro Care Center, Toyoake, Aichi, Japan.'}, {'ForeName': 'Mitsugu', 'Initials': 'M', 'LastName': 'Endo', 'Affiliation': 'Asai Hospital, Togane, Chiba, Japan.'}, {'ForeName': 'Taisuke', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Kisatazu Hospital, Kisarazu, Chiba, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'Katsushikabashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Johmoh Hospital, Maebashi, Gunma, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Murakami', 'Affiliation': 'Sanmaibashi Hospital, Ota, Gunma, Japan.'}, {'ForeName': 'Yukitsugu', 'Initials': 'Y', 'LastName': 'Imamura', 'Affiliation': 'Department of Neuropsychiatry, Asahi General Hospital, Asahi, Chiba, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': 'Yowa Hospital, Tokyo, Japan; Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Goro', 'Initials': 'G', 'LastName': 'Fukami', 'Affiliation': 'Chiba Psychiatric Medical Center, Chiba, Japan.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Project Leader Office, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Biostatistics Section, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Sodegaura-Satsukidai Hospital, Sodegaura, Chiba, Japan.'}, {'ForeName': 'Masatomo', 'Initials': 'M', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Shiina', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Kanahara', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Iyo', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Child Psychiatry, Chiba University Hospital, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102369']
1622,32923016,Efficacy and safety of triazavirin therapy for coronavirus disease 2019: A pilot randomized controlled trial.,"No therapeutics have been proven effective yet for the treatment of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). To assess the efficacy and safety of Triazavirin therapy for COVID-19, we conducted a randomized, double-blinded controlled trial involving hospitalized adult patients with COVID-19. Participants were enrolled from ten sites, and were randomized into two arms of the study with a ratio of 1:1. Patients were treated with Triazavirin 250 mg versus a placebo three or four times a day for 7 d. The primary outcome was set as the time to clinical improvement, defined as normalization of body temperature, respiratory rate, oxygen saturation, cough, and absorption of pulmonary infection by chest computed tomography (CT) until 28 d after randomization. Secondary outcomes included individual components of the primary outcome, the mean time and proportion of inflammatory absorption in the lung, and the conversion rate to a repeated negative SARS-CoV-2 nucleic acid test of throat swab sampling. Concomitant therapeutic treatments, adverse events, and serious adverse events were recorded. Our study was halted after the recruitment of 52 patients, since the number of new infections in the participating hospitals decreased greatly. We randomized 52 patients for treatment with Triazavirin ( n  = 26) or a placebo ( n  = 26). We found no differences in the time to clinical improvement (median, 7 d vs. 12 d; risk ratio (RR), 2.0; 95% confidence interval (CI), 0.7-5.6;  p  = 0.2), with clinical improvement occurring in ten patients in the Triazavirin group and six patients in the placebo group (38.5% vs. 23.1%, RR, 2.1; 95% CI, 0.6-7.0;  p  = 0.2). All components of the primary outcome normalized within 28 d, with the exception of absorption of pulmonary infection (Triazavirin 50.0%, placebo 26.1%). Patients in the Triazavirin group used less frequent concomitant therapies for respiratory, cardiac, renal, hepatic, or coagulation supports. Although no statistically significant evidence was found to indicate that Triazavirin benefits COVID-19 patients, our observations indicated possible benefits from its use to treat COVID-19 due to its antiviral effects. Further study is required for confirmation.",2020,"We found no differences in the time to clinical improvement (median, 7 d vs. 12 d; risk ratio (RR), 2.0; 95% confidence interval (CI), 0.7-5.6;  p  = 0.2), with clinical improvement occurring in ten patients in the Triazavirin group and six patients in the placebo group (38.5% vs. 23.1%, RR, 2.1; 95% CI, 0.6-7.0;  p  = 0.2).","['Participants were enrolled from ten sites', 'hospitalized adult patients with COVID-19', 'coronavirus disease 2019']","['placebo', 'Triazavirin', 'Triazavirin therapy', 'triazavirin therapy']","['time to clinical improvement, defined as normalization of body temperature, respiratory rate, oxygen saturation, cough, and absorption of pulmonary infection by chest computed tomography (CT', 'time to clinical improvement', 'mean time and proportion of inflammatory absorption in the lung, and the conversion rate to a repeated negative SARS-CoV-2 nucleic acid test of throat swab sampling', 'frequent concomitant therapies for respiratory, cardiac, renal, hepatic, or coagulation supports', 'efficacy and safety', 'absorption of pulmonary infection', 'adverse events, and serious adverse events', 'Efficacy and safety']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2714695', 'cui_str': 'triazavirin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",52.0,0.423282,"We found no differences in the time to clinical improvement (median, 7 d vs. 12 d; risk ratio (RR), 2.0; 95% confidence interval (CI), 0.7-5.6;  p  = 0.2), with clinical improvement occurring in ten patients in the Triazavirin group and six patients in the placebo group (38.5% vs. 23.1%, RR, 2.1; 95% CI, 0.6-7.0;  p  = 0.2).","[{'ForeName': 'Xiaoke', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ', ,.'}, {'ForeName': 'Kaijiang', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': ', ,.'}, {'ForeName': 'Yongchen', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ', ,.'}, {'ForeName': 'Wanhai', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': ', ,.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': ', ,.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': ', ,.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ', ,.'}, {'ForeName': 'Benzhi', 'Initials': 'B', 'LastName': 'Cai', 'Affiliation': ', ,.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ', ,.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ', ,.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ', ,.'}, {'ForeName': 'Jingshu', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': ', ,.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ', ,.'}, {'ForeName': 'Huichao', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': ', ,.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ', ,.'}, {'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': ', ,.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ', ,.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ', ,.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ', ,.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ', ,.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Du', 'Affiliation': ', ,.'}, {'ForeName': 'Ben Willem J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': ', ,.'}, {'ForeName': 'Baofeng', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': ', ,.'}]","Engineering (Beijing, China)",['10.1016/j.eng.2020.08.011']
1623,32907500,"Donafenib in Progressive Locally Advanced or Metastatic Radioactive Iodine-Refractory Differentiated Thyroid Cancer: Results of a Randomized, Multicenter Phase II Trial.","Background:  An unmet need for more effective and affordable kinase inhibitors remains in patients with progressive radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) in China, where only sorafenib is approved for this indication. This study evaluated the 24-week objective response rate (ORR) to donafenib-a new, domestic multikinase inhibitor-in the treatment of locally advanced or metastatic RAIR-DTC in patients with measurable lesions. Two dose regimens (300 mg twice daily vs. 200 mg twice daily) were used to determine its optimal dosage and safety for further phase III studies.  Methods:  This study was a randomized, open-label, multicenter phase II trial. Thirty-five adult RAIR-DTC patients with at least one measurable targeted lesion according to RECIST 1.1 were enrolled from 12 centers in China and randomized to receive either 200 mg (17 patients) or 300 mg (18 patients) of donafenib orally twice daily for 24 weeks. The primary endpoint was ORR, and the secondary endpoints included progression-free survival (PFS) among others. Additionally, biochemical (serum thyroglobulin) and structural (total tumor diameter [TTD]) responses were assessed, change (ΔTTD) rates were calculated, and safety was evaluated.  Results:  The ORRs for the 200- and 300-mg arms were 12.5% and 13.33% ( p  = 1.000), respectively. The 300-mg arm had a nonsignificant, longer median PFS than the 200-mg arm (14.98 months vs. 9.44 months) ( p  = 0.351). There was a trend toward more tumor shrinkage in the 300-mg arm compared with the 200-mg arm (average ΔTTD rate -0.52 ± 0.71 vs. -0.04 ± 1.55 mm/month,  p  = 0.103). Most treatment-related adverse events (AEs) in both arms were grades 1-2. The most common grade 3 treatment-related AEs in both arms were palmar-plantar erythrodysesthesia and hypertension; the sum occurrence rates of these two AEs in the 200-mg and 300-mg arms were 11.43% and 22.86%, respectively.  Conclusions:  Donafenib was generally well tolerated. Both donafenib regimens demonstrated similar efficacy in terms of the ORR in locally advanced or metastatic RAIR-DTC. The results warrant further studies on donafenib as a new, feasible treatment option for RAIR-DTC patients. Clinical Trials.gov IDs: NCT02870569; CTR20160220.",2020,Both donafenib regimens demonstrated similar efficacy in terms of the ORR in locally advanced or metastatic RAIR-DTC.,"['locally advanced or metastatic RAIR-DTC in patients with measurable lesions', 'patients with progressive radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) in China', 'RAIR-DTC patients', 'progressive locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer', 'Thirty-five adult RAIR-DTC patients with at least one measurable targeted lesion by RECIST 1.1 were enrolled from 12 centers in China']",['Donafenib'],"['change rates (ΔTTD', 'biochemical (serum thyroglobulin) and structural (total tumor diameter [TTD]) responses', 'palmar-plantar erythrodysesthesia (PPE) and hypertension', 'ORR', 'tumor shrinkage', 'tolerated', '24-week objective response rate (ORR', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C4722172', 'cui_str': 'Primary differentiated carcinoma of thyroid gland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0034553', 'cui_str': 'Radioactivity'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",[],"[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040123', 'cui_str': 'Thyroglobulin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",35.0,0.0652874,Both donafenib regimens demonstrated similar efficacy in terms of the ORR in locally advanced or metastatic RAIR-DTC.,"[{'ForeName': 'Yan-Song', 'Initials': 'YS', 'LastName': 'Lin', 'Affiliation': 'Department of Nuclear Medicine, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Nuclear Medicine, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Nuclear Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yi-Zhuang', 'Initials': 'YZ', 'LastName': 'Cheng', 'Affiliation': 'Department of Nuclear Medicine, Anhui Provincial Hospital, Hefei, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Shi', 'Affiliation': 'Internal Medicine Department of Thyroid and Radionuclide Therapy, Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'Department of Nuclear Medicine, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Zhi-Yong', 'Initials': 'ZY', 'LastName': 'Deng', 'Affiliation': 'Department of Nuclear Medicine, Yunnan Cancer Hospital, Kunming, China.'}, {'ForeName': 'Zhen-Dong', 'Initials': 'ZD', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, The Second Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Rong-Fu', 'Initials': 'RF', 'LastName': 'Wang', 'Affiliation': 'Department of Nuclear Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Qing-Hai', 'Initials': 'QH', 'LastName': 'Ji', 'Affiliation': 'Department of Head and Neck Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': 'Department of Nuclear Medicine, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Lin-Fa', 'Initials': 'LF', 'LastName': 'Li', 'Affiliation': 'Department of Nuclear Medicine, Zhejiang Cancer Hospital, Hangzhou, China.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2020.0235']
1624,32910735,Validation of a Novel Wearable Electromyography Patch for Monitoring Submental Muscle Activity During Swallowing: A Randomized Crossover Trial.,"Purpose Surface electromyography (sEMG) is often used for biofeedback during swallowing rehabilitation. However, commercially available sEMG electrodes are not optimized for the head and neck area, have rigid form, and are mostly available in large medical centers. We developed an ultrathin, soft, and flexible sEMG patch, specifically designed to conform to the submental anatomy and which will be ultimately incorporated into a telehealth system. To validate this first-generation sEMG patch, we compared its safety, efficiency, and signal quality in monitoring submental muscle activity with that of widely used conventional sEMG electrodes. Method A randomized crossover design was used to compare the experimental sEMG patch with conventional (snap-on) sEMG electrodes. Participants completed the same experimental protocol with both electrodes in counterbalanced order. Swallow trials included five trials of 5- and 10-ml water. Comparisons were made on (a) signal-related factors: signal-to-noise ratio (SNR), baseline amplitude, normalized mean amplitude, and sEMG burst duration and (b) safety/preclinical factors: safety/adverse effects, efficiency of electrode placement, and satisfaction/comfort. Noninferiority and equivalence tests were used to examine signal-related factors. Paired  t  tests and descriptive statistics were used to examine safety/preclinical factors. Results Forty healthy adults participated (24 women,  M   age  = 67.5 years). Signal-related factors: SNR of the experimental patch was not inferior to the SNR of the conventional electrodes ( p  < .0056). Similarly, baseline amplitude obtained with the experimental patch was not inferior to that obtained with conventional electrodes ( p  < .0001). Finally, normalized amplitude values were equivalent across swallows (5 ml:  p  < .025; 10 ml:  p  < .0012), and sEMG burst duration was also equivalent (5 ml:  p  < .0001; 10 ml:  p  < .0001). Safety/preclinical factors: The experimental patch resulted in fewer mild adverse effects. Participant satisfaction was higher with the experimental patch ( p  = .0476,  d  = 0.226). Conclusions Our new wearable sEMG patch is equivalent with widely used conventional sEMG electrodes in terms of technical performance. In addition, our patch is safe, and healthy older adults are satisfied with it. With lessons learned from the current COVID-19 pandemic, efforts to develop optimal swallowing telerehabilitation devices are more urgent than ever. Upon further validation, this new technology has the potential to improve rehabilitation and telerehabilitation efforts for patients with dysphagia. Supplemental Material https://doi.org/10.23641/asha.12915509.",2020,"Similarly, baseline amplitude obtained with the experimental patch was not inferior to that obtained with conventional electrodes ( p  < .0001).","['During Swallowing', 'Forty healthy adults participated (24 women,  M   age  = 67.5 years', 'patients with dysphagia', 'healthy older adults']","['Surface electromyography (sEMG', 'sEMG patch with conventional (snap-on) sEMG electrodes', 'Novel Wearable Electromyography Patch']","['sEMG burst duration', 'normalized amplitude values', 'Safety/preclinical factors', 'mild adverse effects', 'signal-related factors: signal-to-noise ratio (SNR), baseline amplitude, normalized mean amplitude, and sEMG burst duration and (b) safety/preclinical factors: safety/adverse effects, efficiency of electrode placement, and satisfaction/comfort', 'Participant satisfaction', 'Monitoring Submental Muscle Activity', 'safety, efficiency, and signal quality']","[{'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1177045', 'cui_str': 'Snap'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]","[{'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",40.0,0.0897228,"Similarly, baseline amplitude obtained with the experimental patch was not inferior to that obtained with conventional electrodes ( p  < .0001).","[{'ForeName': 'Cagla', 'Initials': 'C', 'LastName': 'Kantarcigil', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Min Ku', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'School of Biomedical Engineering, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Taehoo', 'Initials': 'T', 'LastName': 'Chang', 'Affiliation': 'School of Materials Engineering, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Craig', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Chi Hwan', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'School of Biomedical Engineering, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Georgia A', 'Initials': 'GA', 'LastName': 'Malandraki', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-20-00171']
1625,32911214,Cognitive behavioral therapy for persons living with HIV in China: A randomized pilot trial.,"BACKGROUND


Chinese persons living with HIV (PLWH) suffer from prevalent mental health issues. We aimed to develop a tailored cognitive behavioral therapy (CBT), test its feasibility, acceptability, and preliminary effects (depression, anxiety, and medication adherence) for Chinese PLWH.
METHODS


Twenty PLWH were assigned randomly. Intervention participants learned skills in CBT and relaxation training in a tailored group-based weekly 10-session project. Each session lasted for two hours and was delivered by nurses and volunteers. Control participants only received laboratory tests and free antiretroviral therapy (ART) medication. Feasibility and acceptability were descriptively summarized. Depression, anxiety, and ART medication adherence data were collected at the baseline (T0), after the intervention (T1) and after 6 months of follow-up (T2).
RESULTS


The average CBT attendance rate for all sessions was 60%. No participants in the intervention group dropped out of the study. All participants in the intervention group agreed that they could benefit from the CBT. Participants in the intervention group showed a greater improvement in anxiety and self-reported ART medication adherence than those in the control group at T1. However, no preliminary intervention effect was found at T2.
LIMITATIONS


The small sample size leads to a lack of representativeness in the study sample. We excluded participants with severe comorbidities, which may lead to an underestimate of the intervention effect of CBT among Chinese PLWH.
CONCLUSIONS


CBT is feasible and acceptable, demonstrating promising preliminary effects on anxiety and ART medication adherence among Chinese PLWH. Additional research is needed to test the effectiveness of this approach.",2020,Participants in the intervention group showed a greater improvement in anxiety and self-reported ART medication adherence than those in the control group at T1.,"['Twenty PLWH', 'persons living with HIV in China', 'Chinese persons living with HIV (PLWH', 'participants with severe comorbidities, which may lead to an underestimate of the intervention effect of CBT among Chinese PLWH']","['CBT', 'CBT and relaxation training', 'tailored cognitive behavioral therapy (CBT', 'Cognitive behavioral therapy', 'laboratory tests and free antiretroviral therapy (ART) medication']","['average CBT attendance rate', 'Feasibility and acceptability', 'anxiety and self-reported ART medication adherence', 'feasibility, acceptability, and preliminary effects (depression, anxiety, and medication adherence', 'Depression, anxiety, and ART medication adherence data', 'anxiety and ART medication adherence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",20.0,0.0619608,Participants in the intervention group showed a greater improvement in anxiety and self-reported ART medication adherence than those in the control group at T1.,"[{'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'School of Nursing, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, Fudan University, Shanghai 200032, China. Electronic address: huyan@fudan.edu.cn.'}, {'ForeName': 'Hongzhou', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Shanghai Public Health Clinical Center Affiliated with Fudan University, Shanghai 201508, China. Electronic address: luhongzhou@shphc.org.cn.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Public Health Clinical Center Affiliated with Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'School of Nursing, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'School of Public Health, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Relf', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, USA.'}, {'ForeName': 'Marta I', 'Initials': 'MI', 'LastName': 'Mulawa', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, USA.'}, {'ForeName': 'Yaolin', 'Initials': 'Y', 'LastName': 'Pei', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, USA.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.085']
1626,32911306,Long-term safety and efficacy of teriflunomide in patients with relapsing multiple sclerosis: Results from the TOWER extension study.,"BACKGROUND


In the phase 3 TOWER core study (NCT00751881), the efficacy and safety of teriflunomide compared with placebo were demonstrated in patients with relapsing forms of multiple sclerosis (RMS). Here, the long-term safety and efficacy outcomes from the TOWER extension study (NCT00751881) are reported.
METHODS


All patients who entered the extension (N = 751) were assigned to teriflunomide 14 mg and assessed for long-term safety and efficacy.
RESULTS


Of 751 patients in the TOWER extension study, 253, 265, and 233 patients received placebo/teriflunomide 14 mg, teriflunomide 7 mg/14 mg, and teriflunomide 14 mg/14 mg, respectively. Median teriflunomide exposure was 4.25 years (maximum 6.3 years). The overall frequency of adverse events (AEs) was comparable across treatment groups, but a higher proportion of patients in the teriflunomide 7 mg/14 mg (12.4%) and 14 mg/14 mg (12.4%) groups had serious AEs compared with the placebo/teriflunomide 14 mg group (6.4%). Alanine aminotransferase increase and hair thinning occurred at a higher frequency in the placebo/teriflunomide 14 mg group (11.2% and 14.3%, respectively) compared with the teriflunomide 7 mg/14 mg (3.0% and 4.5%, respectively) and 14 mg/14 mg groups (5.2% and 4.3%, respectively). The incidences of AEs of interest (hematologic and hepatic effects, peripheral neuropathy, hypertension, and malignancy) were low and comparable across treatment arms. Disability worsening and adjusted annualized relapse rates were low and stable over time, and mean Expanded Disability Status Scale scores were unchanged over time, for all treatment groups.
CONCLUSION


In the TOWER extension study, the efficacy of teriflunomide 14 mg was maintained in patients with RMS. No new or unexpected AEs were observed with teriflunomide treatment, supporting a safety profile in the extension that was consistent with the core trial. These findings support the positive benefit:risk profile of teriflunomide as a long-term immunomodulatory therapy.",2020,"Alanine aminotransferase increase and hair thinning occurred at a higher frequency in the placebo/teriflunomide 14 mg group (11.2% and 14.3%, respectively) compared with the teriflunomide 7 mg/14 mg (3.0% and 4.5%, respectively) and 14 mg/14 mg groups (5.2% and 4.3%, respectively).","['All patients who entered the extension', '751 patients in the TOWER extension study, 253, 265, and 233 patients received', 'patients with relapsing forms of multiple sclerosis (RMS', 'patients with relapsing multiple sclerosis', 'patients with RMS']","['placebo/teriflunomide 14\xa0mg, teriflunomide', 'placebo', 'placebo/teriflunomide', 'teriflunomide']","['incidences of AEs of interest (hematologic and hepatic effects, peripheral neuropathy, hypertension, and malignancy', 'efficacy and safety', 'Disability worsening and adjusted annualized relapse rates', 'Median teriflunomide exposure', 'mean Expanded Disability Status Scale scores', 'Alanine aminotransferase increase and hair thinning', 'overall frequency of adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3497716', 'cui_str': 'teriflunomide 14 MG'}, {'cui': 'C1718383', 'cui_str': 'teriflunomide'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1718383', 'cui_str': 'teriflunomide'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0151905', 'cui_str': 'Alanine aminotransferase increased'}, {'cui': 'C0020678', 'cui_str': 'Hypotrichosis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",751.0,0.0571361,"Alanine aminotransferase increase and hair thinning occurred at a higher frequency in the placebo/teriflunomide 14 mg group (11.2% and 14.3%, respectively) compared with the teriflunomide 7 mg/14 mg (3.0% and 4.5%, respectively) and 14 mg/14 mg groups (5.2% and 4.3%, respectively).","[{'ForeName': 'Aaron E', 'Initials': 'AE', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, 5 East 98th Street-Box 1138, New York, NY, 10029, United States. Electronic address: aaron.miller@mssm.edu.'}, {'ForeName': 'Tomas P', 'Initials': 'TP', 'LastName': 'Olsson', 'Affiliation': 'Neuroimmunology Unit, Department of Clinical Neuroscience, Karolinska Institutet, Center for Molecular Medicine, L8:04, Karolinska Hospital, 17176 Stockholm, Sweden.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'Department of Neurology, McGovern Medical School, The University of Texas Health Science Center at Houston (UTHealth), 6431 Fannin Street, Houston, TX, 77030, United States.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Petersgraben 4, CH-4031 Basel, Switzerland.'}, {'ForeName': 'Xueqiang', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Neurology, Hospital of Sun Yat-Sen University, 107 Yan Jiang West Road, Guangzhou, China.'}, {'ForeName': 'Xianhao', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Beijing Hospital, No. 1 Dahua Road, Beijing, China.'}, {'ForeName': 'Alex L', 'Initials': 'AL', 'LastName': 'Lublin', 'Affiliation': 'Sanofi, Cambridge, MA, United States.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Truffinet', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Chavin', 'Affiliation': 'Sanofi, Cambridge, MA, United States.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Delhay', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Benamor', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Purvis', 'Affiliation': 'Sanofi, Cambridge, MA, United States.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'The Ottawa Hospital Ontario, 501 Smyth Road, Box 601, Ottawa, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102438']
1627,32911319,"A randomized pilot study assessing the acceptability of rapid point-of-care hepatitis C virus (HCV) testing among male inmates in Montreal, Canada.","BACKGROUND


The Oraquick Ⓡ  fingerprick point-of-care hepatitis C virus antibody (HCV-Ab) test is favoured to venipuncture among people who inject drugs; however, its acceptability in prison populations is unknown. We aimed to compare the acceptability of the Oraquick Ⓡ  versus standard venipuncture among people in prison.
METHODS


From October to December 2019, 280 sentenced male inmates at L'Établissement de Détention de Montréal (Quebec, Canada) were screened for participation, 150 excluded due to prior HCV screening, and 52 refused participation. The remaining 78 were randomized 1:1 to opt-out HCV-Ab screening with OraQuick Ⓡ  or venipuncture (n = 39 each). Acceptability was determined by the proportion accepting to undergo screening.
RESULTS


The majority of participants (median age 33 years) reported a history of drug use (76%; 8% injection drug use); 47% perceived their HCV risk to be moderate/high. All inmates randomized to Oraquick Ⓡ  accepted testing while 87% accepted venipuncture. Among those who accepted Oraquick Ⓡ  vs. venipuncture, 100% vs. 97% were satisfied with the test, 97% vs. 94% would recommend the same test, and 100% vs. 76% would choose the same test again.
CONCLUSION


Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ  compared to venipuncture, and to choose Oraquick Ⓡ  for future HCV screening.",2020,"CONCLUSION


Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ  compared to venipuncture, and to choose Oraquick Ⓡ  for future HCV screening.","[""From October to December 2019, 280 sentenced male inmates at L'Établissement de Détention de Montréal (Quebec, Canada) were screened for participation, 150 excluded due to prior HCV screening, and 52 refused participation"", 'people in prison', 'male inmates in Montreal, Canada', 'Adult incarcerated men in Canada']","['rapid point-of-care hepatitis C virus (HCV', 'venipuncture', 'Ⓡ  or venipuncture', 'HCV-Ab screening with OraQuick', 'Oraquick Ⓡ  versus standard venipuncture']",['Acceptability'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",280.0,0.0431789,"CONCLUSION


Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ  compared to venipuncture, and to choose Oraquick Ⓡ  for future HCV screening.","[{'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Kronfli', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada. Electronic address: nadine.kronfli@mcgill.ca.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Dussault', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Chalifoux', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Hasmig', 'Initials': 'H', 'LastName': 'Kavoukian', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Marina B', 'Initials': 'MB', 'LastName': 'Klein', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada; CIHR Canadian HIV Trials Network, Vancouver, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102921']
1628,32911350,Medication adherence and rate of nicotine metabolism are associated with response to treatment with varenicline among smokers with HIV.,"INTRODUCTION


PLWHA who smoke have shown lower cessation rates within placebo-controlled randomized trials of varenicline. Adherence and rate of nicotine metabolism may be associated with quit rates in such clinical trials.
METHODS


This secondary analysis of a randomized placebo-controlled trial of varenicline for smoking among PLWHA (N = 179) examined the relationship between varenicline adherence (pill count, ≥80% of pills), nicotine metabolism (based on the nicotine metabolite ratio; NMR) and end-of-treatment smoking cessation (self-reported 7-day point prevalence abstinence, confirmed with carbon monoxide of ≤ 8 ppm, at the end of treatment; EOT).
RESULTS


Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates. In separate models, adherence (OR = 1.009, 95% CI:1.004-1.01, p < 0.001) and nicotine metabolism rate (OR = 2.04, 95% CI:1.19-3.49, p = 0.009) interacted with treatment arm to effect quit rates. The quit rate for varenicline vs. placebo was higher for both non-adherent (19% vs. 5%; χ 2 [1] = 2.80, p = 0.09) and adherent (35% vs. 15%; χ 2 [1] = 6.51, p = 0.01) participants, but the difference between treatment arms was statistically significant only for adherent participants. Likewise, among slow metabolizers (NMR < 0.31), the varenicline quit rate was not significantly higher vs. placebo (14% vs. 5%; χ 2 [1] = 1.17, p = 0.28) but, among fast metabolizers (NMR ≥ 0.31), the quit rate for varenicline was significantly higher vs. placebo (33% vs. 14%; χ 2 [1] = 4.43, p = 0.04).
CONCLUSIONS


Increasing varenicline adherence and ensuring that fast nicotine metabolizers receive varenicline may increase quit rates for PLWHA.",2020,"Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates.",['smokers with HIV'],"['varenicline and placebo', 'varenicline', 'varenicline vs. placebo', 'varenicline adherence (pill count, ≥80% of pills), nicotine metabolism (based on the nicotine metabolite ratio; NMR) and end-of-treatment smoking cessation', 'placebo']","['nicotine metabolism rate', 'varenicline quit rate', 'quit rate for varenicline', 'quit rate', 'Medication adherence and rate of nicotine metabolism', 'faster nicotine metabolism']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1095963', 'cui_str': 'Smoking cessation therapy'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",179.0,0.482863,"Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates.","[{'ForeName': 'Anna-Marika', 'Initials': 'AM', 'LastName': 'Bauer', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Hosie Quinn', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Su Fen', 'Initials': 'SF', 'LastName': 'Lubitz', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Flitter', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Ashare', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Frank T', 'Initials': 'FT', 'LastName': 'Leone', 'Affiliation': 'Department of Medicine/Division of Pulmonary, Allergy, & Critical Care, University of Pennsylvania, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Department of Medicine/Division of Infectious Diseases, University of Pennsylvania, United States; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hitsman', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schnoll', 'Affiliation': 'Department of Psychiatry and Abramson Cancer Center, University of Pennsylvania, United States. Electronic address: schnoll@pennmedicine.upenn.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106638']
1629,32905977,A preliminary study on the application of DTI in the treatment of brain tumors in motor function areas with gamma knife.,"OBJECTIVES


The treatment safety and efficiency as well as the life quality of patients are still main concerns in gamma knife radiosurgery. In this study, the feasibility of applying diffusion tensor imaging (DTI) in gamma knife radiosurgery for the treatment of brain tumor in motor function areas was investigated, which aims to provide protection on the pyramidal tract and preserve the motor function in patients.
PATIENTS AND METHODS


Total 74 patients with solid brain tumor were enrolled and divided into DTI group and control group. The tumor control rate was assessed at 3 months after surgery. The muscle strength of affected limb, KPS scores, ZEW scores and complications were evaluated at 3 and 6 months after gamma knife radiosurgery.
RESULTS


Our results indicated that the tumor control rate, complication rate, the muscle strength of affected limb and KPS scores were not significantly different between the two groups at 3 months after surgery. At 6 months after gamma knife radiosurgery, the complication rate (0% vs 50 %, P = 0.044), KPS scores (64.9 % vs 37.8 %, P = 0.036) and ZEW scores (78.4 % vs 54.1 %, P = 0.044) of DTI group were better than the control group. Furthermore, the stability of muscle strength in patients with limb dysfunction was significantly improved in DTI group (86.4 % vs 50 %, P = 0.028).
CONCLUSION


In summary, the application of DTI in gamma knife radiosurgery for the treatment of brain tumors in motor function areas can precisely define the tumor edge from pyramidal tract, which will support on designing individual treatment plan, reducing the incidence of complications, and improving long-term life quality in patients.",2020,"At 6 months after gamma knife radiosurgery, the complication rate (0% vs 50 %, P = 0.044), KPS scores (64.9 % vs 37.8 %, P = 0.036) and ZEW scores (78.4 % vs 54.1 %, P = 0.044) of DTI group were better than the control group.","['Total 74 patients with solid brain tumor were enrolled and divided into DTI group and control group', 'patients', 'brain tumors in motor function areas with gamma knife']","['DTI', 'diffusion tensor imaging (DTI', 'gamma knife radiosurgery']","['tumor control rate', 'ZEW scores', 'limb dysfunction', 'tumor control rate, complication rate, the muscle strength of affected limb and KPS scores', 'complication rate', 'KPS scores', 'muscle strength of affected limb, KPS scores, ZEW scores and complications', 'stability of muscle strength']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0086330', 'cui_str': 'Radiosurgery, Gamma Knife'}]","[{'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0086330', 'cui_str': 'Radiosurgery, Gamma Knife'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",74.0,0.018093,"At 6 months after gamma knife radiosurgery, the complication rate (0% vs 50 %, P = 0.044), KPS scores (64.9 % vs 37.8 %, P = 0.036) and ZEW scores (78.4 % vs 54.1 %, P = 0.044) of DTI group were better than the control group.","[{'ForeName': 'Yadi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China. Electronic address: hongweiwangimmu@yahoo.com.'}, {'ForeName': 'Zhanbiao', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Magnetic Resonance Imaging, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Jianbo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Nuclear Medicine, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Guorong', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106169']
1630,32911680,Metabonomic Responses of Grazing Yak to Different Concentrate Supplementations in Cold Season.,"Supplementation plays an important role in reversing the weight loss of grazing yaks during cold season. However, little is known about the effect of supplementation on the serum metabolites of grazing yaks. The objective of this study was to explore the effects of supplementary feeding on average daily gain (ADG) and serum metabolites with nuclear magnetic resonance (NMR)-based metabolomics method in growing yaks during cold season on the Qinghai-Tibetan plateau. Twenty 1.5-year-old female yaks (91.38 ± 10.43 kg LW) were evenly divided into three treatment groups and a control group (CON) ( n  = 5 per group). All the yaks were released to graze during daytime, whereas the yaks in the treatment groups were supplemented with highland barley (HLB), rapeseed meal (RSM), and highland barley plus rapeseed meal (HLB + RSM) at night. The whole experiment lasted for 120 days. Results indicated that the ADG of growing yak heifers was increased by concentrate supplementations, and ADG under HLB and HLB + RSM group was 37.5% higher ( p  < 0.05) than that with RSM supplementation. Supplementary feeding increased the plasma concentrations of total protein (TP), albumin (ALB), and blood urea nitrogen (BUN) of those in the CON group, and concentrations of BUN were higher in the RSM group than in the HLB and HLB + RSM group. Compared with the CON group, serum levels of glutamine, glycine, β-glucose were lower and that of choline was higher in the HLB group; serum levels of lactate were lower and that of choline, glutamate were higher in the HLB + RSM group. Compared with the HLB + RSM group, serum levels of glycerophosphoryl choline (GPC) and lactate were higher, and those of choline, glutamine, glutamate, leucine,  N -acetyaspartate, α-glucose, and β-glucose were lower in the HLB group; serum levels of citrate, GPC and lactate were higher, and those of 3-Hydroxybutyrate, betaine, choline, glutamate, glutamine,  N -acetylglycoprotein,  N -acetyaspartate, α-glucose, and β-glucose were lower in the RSM group. It could be concluded that concentrate supplementations significantly improved the growth performance of growing yaks and supplementation with HBL or HLB plus RSM was better than RSM during the cold season. Supplementation with HBL or HLB plus RSM affected the serum metabolites of grazing yaks, and both treatments promoted lipid synthesis. Supplementation of yaks with HBL plus RSM could improve energy-supply efficiency, protein and lipid deposition compared with HLB and RSM.",2020,"Compared with the CON group, serum levels of glutamine, glycine, β-glucose were lower and that of choline was higher in the HLB group; serum levels of lactate were lower and that of choline, glutamate were higher in the HLB + RSM group.",['Twenty 1.5-year-old female yaks (91.38 ± 10.43 kg LW'],"['RSM', 'HLB + RSM', 'HBL plus RSM', 'HBL or HLB plus RSM', 'control group (CON', 'CON', 'supplementary feeding', 'highland barley (HLB), rapeseed meal (RSM), and highland barley plus rapeseed meal (HLB + RSM']","['average daily gain (ADG) and serum metabolites', 'serum metabolites of grazing yaks', 'growth performance', '3-Hydroxybutyrate, betaine, choline, glutamate, glutamine,  N -acetylglycoprotein,  N -acetyaspartate, α-glucose, and β-glucose', 'concentrations of BUN', 'serum levels of glycerophosphoryl choline (GPC) and lactate', 'choline, glutamine, glutamate, leucine,  N -acetyaspartate, α-glucose, and β-glucose', 'serum levels of lactate', 'serum levels of citrate, GPC and lactate', 'energy-supply efficiency, protein and lipid deposition', 'serum levels of glutamine, glycine, β-glucose', 'plasma concentrations of total protein (TP), albumin (ALB), and blood urea nitrogen (BUN', 'lipid synthesis']","[{'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0325253', 'cui_str': 'Bos grunniens'}]","[{'cui': 'C0206624', 'cui_str': 'Hepatoblastoma'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}, {'cui': 'C0454911', 'cui_str': 'Highland'}, {'cui': 'C0004755', 'cui_str': 'Hordeum'}, {'cui': 'C0034670', 'cui_str': 'Brassica rapa'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0325253', 'cui_str': 'Bos grunniens'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C1415375', 'cui_str': 'Glycophorin D'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0333574', 'cui_str': 'Fatty deposition'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C1563744', 'cui_str': 'Lipogenesis'}]",,0.0214806,"Compared with the CON group, serum levels of glutamine, glycine, β-glucose were lower and that of choline was higher in the HLB group; serum levels of lactate were lower and that of choline, glutamate were higher in the HLB + RSM group.","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Animal Nutrition Institute, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Shuangming', 'Initials': 'S', 'LastName': 'Yue', 'Affiliation': 'Animal Nutrition Institute, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Quanhui', 'Initials': 'Q', 'LastName': 'Peng', 'Affiliation': 'Animal Nutrition Institute, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Lizhi', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Animal Nutrition Institute, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Zhisheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Animal Nutrition Institute, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Bai', 'Initials': 'B', 'LastName': 'Xue', 'Affiliation': 'Animal Nutrition Institute, Sichuan Agricultural University, Chengdu 611130, China.'}]",Animals : an open access journal from MDPI,['10.3390/ani10091595']
1631,32920186,"An invited commentary on: ""A randomized controlled trial on irrigation of open appendectomy wound with gentamicin-saline solution versus saline solution for prevention of surgical site infection"" (International Journal of Surgery 2020).",,2020,,[],['Gentamicin-Saline Solution versus Saline Solution'],[],[],"[{'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]",[],,0.304305,,"[{'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Akay', 'Affiliation': 'Emergency Medicine Clinic, University of Health Sciences, Izmir Bozyaka Education and Research Hospital, Izmir, Turkey. Electronic address: howls_Castle@mynet.com.'}, {'ForeName': 'Huriye', 'Initials': 'H', 'LastName': 'Akay', 'Affiliation': 'Emergency Medicine Clinic, University of Health Sciences, Izmir Bozyaka Education and Research Hospital, Izmir, Turkey.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.09.009']
1632,32920219,COVID-19 associated kidney impairment in adult: Qualitative and quantitative analyses with non-enhanced CT on admission.,"PURPOSE


To qualitatively and quantitatively assess kidney imapairment in adults with COVID-19 by analysing imaging features on non-enhanced CT (NECT) and possible correlation between renal parenchymal attenuation (RPA) and serum creatinine (SCr) levels on admission.
METHODS


This study was approved by the local institutional ethics committee. A total of 82 patients with COVID-19 admitted from 10/1/2020∼15/3/2020 were enrolled. RPA and perinephric fat stranding (PFS) were evaluated on NECT imaging. According to the presence of PFS, the patients were divided into two groups: Group A, 38 patients with PFS, and Group B, 44 patients without PFS. Clinical data, including age, gender, clinical classification, SCr levels, and RPA on NECT were analysed. The RPA and SCr of the two groups with COVID-19 were analysed to determine possible difference and correlation. Eighty subjects with no kidney diseases were randomly selected as control group to determine the RPA of normal kidney performed on the same CT scanner.
RESULTS


Mean age, male to female ratio, number of severe and critical cases, and SCr of Group A were higher than those of Group B. Both mean RPA of Group A and Group B were lower than that of control. Mean RPA of Group A was even lower than that of Group B. A significant weak negative linear correlation between RPA on NECT and SCr in COVID-19 was indicated.
CONCLUSIONS


Decrease in RPA on NECT was observed in patients with COVID-19 and a weak linear negative correlation with SCr levels was found. The presence of PFS suggested more severe renal impairment in COVID-19. RPA measurements and PFS could be useful in quantitative and qualitative evaluation of COVID-19 associated renal impairment on admission.",2020,RPA measurements and PFS could be useful in quantitative and qualitative evaluation of COVID-19 associated renal impairment on admission.,"['82 patients with COVID-19 admitted from 10/1/2020∼15/3/2020 were enrolled', '38 patients with PFS, and Group B, 44 patients without PFS', 'adults with COVID-19 by analysing imaging features on non-enhanced CT (NECT', 'Eighty subjects with no kidney diseases']",[],"['Mean RPA', 'renal parenchymal attenuation (RPA) and serum creatinine (SCr) levels on admission', 'severe renal impairment', 'RPA on NECT', 'SCr levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0227617', 'cui_str': 'Structure of fatty capsule of kidney'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]",82.0,0.0205873,RPA measurements and PFS could be useful in quantitative and qualitative evaluation of COVID-19 associated renal impairment on admission.,"[{'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Electrocadiogram, Affiliated Hangzhou First People's Hospital, College of Medicine, Zhejiang University, 261 Huansha Road, 310006, Hangzhou, Zhejiang, People's Republic of China; Department of Cardiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Shuangzhi', 'Initials': 'S', 'LastName': 'Lyu', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Jinpeng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Senxiang', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': ""Department of Radiation Oncology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Liangrong', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': ""Department of Cardiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China. Electronic address: 1191066@zju.edu.cn.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China. Electronic address: chenfenghz@zju.edu.cn.""}]",European journal of radiology,['10.1016/j.ejrad.2020.109240']
1633,32920228,"The effect of pain neurophysiology education on healthcare students' knowledge, attitudes and behaviours towards pain: A mixed-methods randomised controlled trial.","OBJECTIVE


1) To investigate the effects of a brief pain neuroscience education (PNE) lecture on multi-disciplinary healthcare students' knowledge, attitudes and behaviours towards people with pain post intervention and at 6-months follow-up, 2) To explore students' perceptions of PNE.
DESIGN


Mixed-methods randomized controlled trial.
SETTING


UK university.
PARTICIPANTS


Thirty-seven students (30♀, mean age 30 years) from six healthcare disciplines.
INTERVENTION


70-min PNE lecture (intervention group) or a 70-min control education.
MAIN OUTCOME MEASURES


1) Knowledge: The Revised Pain Neurophysiology Quiz (RPNQ); 2) Attitudes: Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS); 3) Behaviours: A case vignette to assess clinical recommendations; and 4) Thematic analysis of semi-structured interviews (n = 12).
RESULTS


The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860). Greater improvements in attitudes for the intervention group were seen post-intervention [-10.4 (-16.3, -4.6), P < 0.001] and at 6-months [-5.8 (-11.5, -0.2), P < 0.044]. There was no difference in behaviours between groups. Thematic analysis identified increased patient empathy, partial and patchy reconceptualisation of pain and increased confidence in recommending an active management programme following PNE.
CONCLUSION


This study adds to existing knowledge by demonstrating that a 70-min PNE lecture can have a short-term effect on knowledge and positively shift attitudes towards people with pain in the short and medium-term. It also resulted in some students' reconceptualisation of pain, increased empathy, and confidence to recommend activity. The effect of PNE on clinical behaviours was unclear.",2020,"The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860).","['UK university', 'healthcare students', 'Knowledge', 'Attitudes', 'Thirty-seven students (30♀, mean age 30 years) from six healthcare disciplines']","['pain neurophysiology education', 'pain neuroscience education (PNE) lecture', '70-min PNE lecture (intervention group) or a 70-min control education', 'PNE']","['knowledge', 'patient empathy, partial and patchy reconceptualisation of pain', ""Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS"", 'knowledge, attitudes and behaviours towards pain', 'pain, increased empathy, and confidence to recommend activity']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027901', 'cui_str': 'Neurophysiology'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3489398', 'cui_str': 'Peripheral neuroepithelioma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205413', 'cui_str': 'Patchy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.210237,"The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860).","[{'ForeName': 'Jagjit', 'Initials': 'J', 'LastName': 'Mankelow', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom. Electronic address: j.mankelow@tees.ac.uk.'}, {'ForeName': 'Cormac', 'Initials': 'C', 'LastName': 'Ryan', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Taylor', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102249']
1634,32920843,Letrozole versus clomiphene citrate for ovulation induction in anovulatory women with polycystic ovarian syndrome: A randomized controlled trial.,"OBJECTIVE


To compare the efficacy of letrozole and clomiphene citrate (CC) for ovulation induction in infertile women with polycystic ovarian syndrome (PCOS).
METHODS


In this assessor blind, randomized controlled trial, 90 infertile women with PCOS were randomized to receive either letrozole or CC for ovulation induction in incremental doses for a maximum of three cycles. Main outcome measures studied were endometrial thickness, ovulation rate, pregnancy rate, rate of monofollicular development, and time to conception.
RESULTS


Mean endometrial thicknesses were 9.86 ± 2.32 mm and 9.39 ± 2.06 mm with letrozole and CC, respectively (P=0.751). Cumulative ovulation rates were 86.7% and 85.2% with letrozole and CC, respectively (P=0.751). Pregnancy was achieved in 42.2% of women in the letrozole group and 20.0% of women in the CC group (P=0.04). Monofollicular development was seen in 68.4% of ovulatory cycles in the letrozole group compared with 44.8% in the CC group (P=0.000). Mean time to achieve pregnancy was significantly shorter (log rank P=0.042) with letrozole (9.65 weeks) than with CC (11.07 weeks).
CONCLUSION


Letrozole is a better alternative for ovulation induction in anovulatory women with PCOS as pregnancy rates are higher, time to pregnancy is shorter, and chances of multiple pregnancy are less because of high monofollicular growth.",2020,"Mean time to achieve pregnancy was significantly shorter (log rank p = .042) with letrozole (9.65 weeks) than with CC (11.07).
","['anovulatory women with PCOS', '90 infertile women with PCOS', 'infertile women with polycystic-ovarian-syndrome (PCOS']","['letrozole or CC', 'letrozole and clomiphene citrate (CC', 'letrozole', 'Letrozole', 'letrozole & clomiphene', 'clomiphene', 'letrozole and clomiphene', 'clomiphene citrate']","['Pregnancy', 'Mean endometrial thickness', 'Cumulative ovulation rate', 'endometrial thickness, ovulation rate, pregnancy rate, rate of mono-follicular development and time to conception', 'Mean time to achieve pregnancy', 'Mono-follicular development']","[{'cui': 'C0429468', 'cui_str': 'Anovulatory'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0009008', 'cui_str': 'Clomiphene'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009637', 'cui_str': 'Conception'}]",90.0,0.27462,"Mean time to achieve pregnancy was significantly shorter (log rank p = .042) with letrozole (9.65 weeks) than with CC (11.07).
","[{'ForeName': 'Shavina', 'Initials': 'S', 'LastName': 'Bansal', 'Affiliation': 'Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': 'Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Charu', 'Initials': 'C', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Shashank', 'Initials': 'S', 'LastName': 'Shekhar', 'Affiliation': 'Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13375']
1635,32921665,"Randomized, Open-Label, Cross-Over Comparison of the Effects of Benzbromarone and Febuxostat on Endothelial Function in Patients with Hyperuricemia.","Uric acid is generated with reactive oxygen species via xanthine oxidase (XO), and hyperuricemia, which is identified as the excess of uric acid in the blood, has been associated with vascular endothelial dysfunction. However, the effects of urate-lowering medicines on endothelial function have not been fully elucidated. Thus this study determined and compared the effects of benzbromarone (urate transporter 1 inhibitor) and febuxostat (XO inhibitor) on endothelial function.This randomized, cross-over, open-label study initially recruited 30 patients with hyperuricemia. They were divided into two groups, treated initially with benzbromarone or febuxostat for three months and then were switched for the next three months. Endothelial function was defined as reactive hyperemia indexes (RHI) determined using Endo-PAT 2000 before and at three and six months after medication using the two agents. Blood levels of asymmetric dimethylarginine (ADMA) and high-molecular-weight (HMW) adiponectin were also compared. We finally analyzed data from 24 patients whose endothelial function was assessed as described above.Our findings show that levels of uric acid significantly decreased, whereas those of HMW adiponectin and the RHI have significantly increased after treatment with benzbromarone. Meanwhile, in patients administered with febuxostat, uric acid levels tended to decrease and RHI significantly decreased. Neither of the two agents altered ADMA levels. The changes in RHI (P = 0.026) and HMW adiponectin levels (P = 0.001) were found to be significantly greater in patients treated with benzbromarone than febuxostat. Changes in the levels of HMW adiponectin and of uric acid were significantly correlated (r = -0.424, P = 0.039).Benzbromarone has increased adiponectin besides reducing uric acid levels, and thus, this might confer more benefits on endothelial function than febuxostat.",2020,"Changes in the levels of HMW adiponectin and of uric acid were significantly correlated (r = -0.424, P = 0.039).Benzbromarone has increased adiponectin besides reducing uric acid levels, and thus, this might confer more benefits on endothelial function than febuxostat.","['30 patients with hyperuricemia', 'Patients with Hyperuricemia']","['benzbromarone or febuxostat', 'benzbromarone (urate transporter 1 inhibitor) and febuxostat (XO inhibitor', 'benzbromarone', 'urate-lowering medicines', 'febuxostat', 'Benzbromarone and Febuxostat']","['Endothelial Function', 'ADMA levels', 'reactive hyperemia indexes (RHI', 'levels of uric acid', 'levels of HMW adiponectin and of uric acid', 'changes in RHI', 'Endothelial function', 'HMW adiponectin levels', 'Blood levels of asymmetric dimethylarginine (ADMA) and high-molecular-weight (HMW) adiponectin', 'endothelial function', 'HMW adiponectin and the RHI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}]","[{'cui': 'C0005035', 'cui_str': 'Benzbromarone'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0534759', 'cui_str': 'urate transporter'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0302609', 'cui_str': 'Xanthine oxidase inhibitor'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C2733715', 'cui_str': 'High molecular weight adiponectin'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}]",30.0,0.0196686,"Changes in the levels of HMW adiponectin and of uric acid were significantly correlated (r = -0.424, P = 0.039).Benzbromarone has increased adiponectin besides reducing uric acid levels, and thus, this might confer more benefits on endothelial function than febuxostat.","[{'ForeName': 'Tomoo', 'Initials': 'T', 'LastName': 'Nakata', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Ikeda', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Koga', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Yonekura', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tsuneto', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Doi', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Satoki', 'Initials': 'S', 'LastName': 'Fukae', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Minami', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kawano', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Maemura', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}]",International heart journal,['10.1536/ihj.20-114']
1636,32920135,"Therapeutic effects of andiroba (Carapa guianensis Aubl) oil, compared to low power laser, on oral mucositis in children underwent chemotherapy: A clinical study.","ETHNO-PHARMACOLOGICAL RELEVANCE


The Carapa guianensis Aubl, popularly known as andiroba, is a large tree of the Meliaceae family, commonly found in the Amazon region. The oil extracted from its seeds is recognized in traditional medicine and has high anti-inflammatory and analgesic potential, which are the basic prerequisites for a therapeutic agent that can be used in the treatment of oral mucositis (OM). Moreover, the aforementioned oil has antimicrobial, antiallergic, and parasiticidal actions and is effective in the management of cutaneous and muscular dysfunctions.
AIM OF THE STUDY


To evaluate the therapeutic effects of andiroba gel (Carapa guianensis Aubl) on the symptomatology and evolution of OM in children with leukemia who underwent chemotherapy and to compare it to the effects of low power laser.
MATERIALS AND METHODS


This randomized, double-blind clinical trial involved 60 patients of both genders with leukemia, with age ranging from six to twelve years. The patients were divided into two study groups: the andiroba group (n = 30) and the laser group (n = 30). The level of pain experienced by the patients was assessed using the Wong-Baker visual analog scale and the degree of severity of OM was assessed using a table, recommended by the World Health Organization, that depicts the degrees of severity of OM. The data obtained were analyzed using the Mann-Whitney test, with statistical significance indicated by a P value less than or equal to 0.05.
RESULTS


A statistically significant reduction in the degree of OM was observed on the fourth, fifth, and sixth days and in the pain scores on the second, third, and fourth days in the andiroba group after the manifestation of OM, compared to the laser group.
CONCLUSIONS


The use of andiroba oil effectively reduced the severity of OM and relieved pain, which resulted in a decrease in the severity of signs and symptoms in the patients in the andiroba group, compared to the laser group.",2020,"RESULTS


A statistically significant reduction in the degree of OM was observed on the fourth, fifth, and sixth days and in the pain scores on the second, third, and fourth days in the andiroba group after the manifestation of OM, compared to the laser group.
","['children underwent', 'children with leukemia who underwent', '60 patients of both genders with leukemia, with age ranging from six to twelve years']","['andiroba gel (Carapa guianensis Aubl', 'chemotherapy', 'andiroba (Carapa guianensis Aubl) oil']","['Baker visual analog scale and the degree of severity of OM', 'degree of OM', 'severity of OM and relieved pain', 'level of pain', 'pain scores', 'severity of signs and symptoms', 'oral mucositis', 'symptomatology and evolution of OM']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C1258042', 'cui_str': 'Carapa'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0441982', 'cui_str': 'Degrees of severity'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}]",60.0,0.0241249,"RESULTS


A statistically significant reduction in the degree of OM was observed on the fourth, fifth, and sixth days and in the pain scores on the second, third, and fourth days in the andiroba group after the manifestation of OM, compared to the laser group.
","[{'ForeName': 'Artur Dos Santos', 'Initials': 'ADS', 'LastName': 'Soares', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil. Electronic address: artur_soares_@hotmail.com.'}, {'ForeName': 'Ana Márcia Viana', 'Initials': 'AMV', 'LastName': 'Wanzeler', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil. Electronic address: marciawanzeler@hotmail.com.'}, {'ForeName': 'Gabriel Henrique Soares', 'Initials': 'GHS', 'LastName': 'Cavalcante', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil. Electronic address: gabrielhscavalcante@gmail.com.'}, {'ForeName': 'Elsa Maria da Silva', 'Initials': 'EMDS', 'LastName': 'Barros', 'Affiliation': 'Radiotherapy Service of Hospital Ophir Loyola, Avenue. Gov Magalhães Barata, Number 992, 66060-281, Belém, PA, Brazil. Electronic address: elsabarros12345@gmail.com.'}, {'ForeName': 'Rita de Cássia Matos', 'Initials': 'RCM', 'LastName': 'Carneiro', 'Affiliation': 'Radiotherapy Service of Hospital Ophir Loyola, Avenue. Gov Magalhães Barata, Number 992, 66060-281, Belém, PA, Brazil. Electronic address: ritacarneiro69@yahoo.com.br.'}, {'ForeName': 'Fabrício Mesquita', 'Initials': 'FM', 'LastName': 'Tuji', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil; Radiotherapy Service of Hospital Ophir Loyola, Avenue. Gov Magalhães Barata, Number 992, 66060-281, Belém, PA, Brazil. Electronic address: fmtuji@gmail.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113365']
1637,32931029,Impact of adjuvant trastuzumab on locoregional failure rates in a randomized clinical trial: North Central Cancer Treatment Group N9831 (alliance) study.,"BACKGROUND


The goal of this study was to assess the impact of trastuzumab on locoregional failure.
METHODS


The analysis included 2763 patients with HER2-positive (HER2+) breast cancer who were randomly assigned to adjuvant doxorubicin (A), cyclophosphamide (C), paclitaxel (T) and trastuzumab (H) (arm A, AC→T [n = 922]; arm B, AC→T→H [n = 988]; arm C, AC→T+H→H [n = 853]). Radiotherapy was given after AC→T concurrently with H. Radiotherapy was given after lumpectomy (L) or after mastectomy (M) with ≥4 positive lymph nodes but was optional for 1 to 3 positive lymph nodes. Locoregional failures at 10 years (LFR10) as first events were compared using competing risk analysis.
RESULTS


The median follow-up was 13.0 years. The first site of failure was local-only in 96 cases, locoregional in 16 cases, regional in 32 cases, and not specified in 2 cases; LFR10 was 4.8% (95% CI 4.1%-5.7%). LFR10 was 5.5% (95% CI 4.3%-7.2%), 4.9% (95% CI 3.7%-6.4%), and 2.8% (95% CI 1.9%-4.1%) in arms A, B, and C (B vs A: hazard ratio [HR] 0.91, P = .62; C vs A: HR 0.72, P = .12). For estrogen receptor-positive patients, LFR10 was 3.7% (95% CI 2.8%-4.8%) and for estrogen receptor-negative patients, it was 6.1% (95% CI 5.0%-7.4%; HR 0.61, P = .004). Local treatment included L+RT (n = 1044 [38%]), M+RT (n = 1025 [37%]), and M (n = 694 [25%]). LFR10 was 6.% (95% CI 5.0%-7.8%), 3.0% (95% CI 2.1%-4.3%), and 5.5% (95% CI 4.0%-7.4%) for L+RT, M+RT, and M, respectively (M+RT vs L+RT: HR 0.43, P < .001; M vs L+RT: HR 0.88, P = .57). For 1 to 3 positive lymph nodes, LFR10 was 6.5% (95% CI 4.8%-8.9%), 4.1% (95% CI 2.4%-7.0%), and 4.3% (95% CI 2.9%-6.5%) in L+RT, M+RT, and M, respectively (M vs L+RT: HR 0.68, P = .14; M vs M+RT: HR 1.2, P = .6).
CONCLUSION


Low 10-year LFRs were seen regardless of trastuzumab use. Differences in local therapy in patients with 1 to 3 positive lymph nodes did not appear to improve local control. Local therapy studies for HER2+ and other tumor characteristics are important as the role of local therapies continues to evolve.",2020,"(M vs L+RT: HR 0.68, P = .14;","['2763 patients with HER2-positive (HER2+) breast cancer', 'patients with 1 to 3 positive lymph nodes']","['L+RT', 'adjuvant trastuzumab', 'trastuzumab', 'adjuvant doxorubicin (A), cyclophosphamide (C), paclitaxel (T) and trastuzumab (H) (arm A, AC→T [n\xa0=\xa0922]; arm B, AC→T→H [n\xa0=\xa0988]; arm C, AC→T+H→H', 'M+RT', 'Radiotherapy']","['LFR10', 'Locoregional failures', 'locoregional failure rates', 'local control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",2763.0,0.165357,"(M vs L+RT: HR 0.68, P = .14;","[{'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Vargas', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Cameron S', 'Initials': 'CS', 'LastName': 'Thorpe', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Amylou C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Kathleen S', 'Initials': 'KS', 'LastName': 'Tenner', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Davidson', 'Affiliation': 'Division of Medical Oncology, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'The Angeles Clinic and Research Institute, Santa Monica, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Pisansky', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'E Shelley', 'Initials': 'ES', 'LastName': 'Hwang', 'Affiliation': 'Department of Surgery, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michele Y', 'Initials': 'MY', 'LastName': 'Halyard', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Pockaj', 'Affiliation': 'Department of Surgery, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': 'Department of Hematology & Oncology, Mayo Clinic, Jacksonville, Florida.'}]",Cancer,['10.1002/cncr.33154']
1638,32925629,Characteristics Associated With Consent and Reasons for Declining in a Randomized Trial in Pregnancy.,"OBJECTIVE


To evaluate the maternal characteristics associated with consent to a randomized trial of labor induction in pregnancy.
METHODS


This is a secondary analysis of low-risk nulliparous women randomized to induction of labor at 39 weeks or expectant management. During the trial, the Data and Safety Monitoring Committee requested additional fields on the screening log, which already included race and ethnicity: maternal age, type of insurance, and the reason for declining consent if declined.
RESULTS


From August 2016 (start of additional data collection) to August 2017, 1,965 (28%) of the 7,112 eligible women consented to the trial. Consent was more likely for Black women (41%, adjusted odds ratio [aOR] 1.47, 95% CI 1.24-1.74), and less likely for Asian women (15%, aOR 0.64, 95% CI 0.48-0.84), compared with White women (24%). Women without private insurance were more likely to consent (38%, aOR 1.55, 95% CI 1.34-1.79), compared with those with private insurance (22%). Younger women were also more likely to consent. Among eligible women who declined participation and provided a reason (68%), preference to be expectantly managed (85%) was most common, a response more common in Asian women (aOR 1.75, 95% CI 1.31-2.33) and less common in women without private insurance (aOR 0.60, 95% CI 0.51-0.70). Not wanting to participate in research was more common in Asian women (aOR 2.41, 95% CI 1.44-4.03). Declining consent because family or friends objected was more common in Asian women (aOR 2.51, 95% CI 1.27-4.95) and women without private insurance (aOR 1.68, 95% CI 1.10-2.59).
CONCLUSION


Frequency of consent and reasons for declining consent were associated with age, type of insurance, and race and ethnicity. These findings should be considered when developing recruitment strategies that promote diverse participant representation.
CLINICAL TRIAL REGISTRATION


ClinialTrials.gov, NCT01990612.",2020,"Women without private insurance were more likely to consent (38%, aOR 1.55, 95% CI 1.34-1.79), compared with those with private insurance (22%).","['low-risk nulliparous women', 'From August 2016 (start of additional data collection) to August 2017, 1,965 (28%) of the 7,112 eligible women consented to the trial', 'Younger women']",[],[],"[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],[],7112.0,0.369739,"Women without private insurance were more likely to consent (38%, aOR 1.55, 95% CI 1.34-1.79), compared with those with private insurance (22%).","[{'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mallett', 'Affiliation': ""Departments of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois, University of Utah Health Sciences Center, Salt Lake City, Utah, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Alabama at Birmingham, Birmingham, Alabama, University of Texas Medical Branch at Galveston, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Pennsylvania, Philadelphia, Pennsylvania, and University of Pittsburgh, Pittsburgh, Pennsylvania; and the George Washington University Biostatistics Center, Washington, DC.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'de Voest', 'Affiliation': ''}, {'ForeName': 'Sabine Z', 'Initials': 'SZ', 'LastName': 'Bousleiman', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Allard', 'Affiliation': ''}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': ''}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Salazar', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'Felecia', 'Initials': 'F', 'LastName': 'Ortiz', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bartholomew', 'Affiliation': ''}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Dalton', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Craig', 'Affiliation': ''}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Bickus', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003998']
1639,32925634,Customized Probability of Vaginal Delivery With Induction of Labor and Expectant Management in Nulliparous Women at 39 Weeks of Gestation.,"OBJECTIVE


To develop models to predict vaginal delivery in low-risk, nulliparous women contemplating elective induction of labor or expectant management at 39 weeks of gestation.
METHODS


We conducted a secondary analysis of a randomized controlled trial of planned elective induction of labor at 39 weeks of gestation compared with expectant management for low-risk nulliparous women. Two groups were included for this analysis: 1) women who were randomized to the induction of labor group and underwent elective induction at 39 0/7-39 4/7 weeks of gestation and 2) women who were randomized to the expectant management group who experienced spontaneous labor or medically indicated delivery (including postterm). Multivariable logistic regression models were developed for each group using patient characteristics that would be available at the time of counseling. Model selection was based on k-fold cross-validation using backward elimination and variables that remained significant at P<.05 were retained. To compare estimated with observed rates, the elective induction of labor model was then applied to each woman in both groups to estimate individualized predicted probabilities of vaginal delivery with elective induction of labor.
RESULTS


Of 6,106 women enrolled in the trial, 4,661 met criteria for this analysis. Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group (P=.005). The final elective induction of labor model included age, height, weight, and modified Bishop score (area under the receiver operating characteristic curve [AUROC] 0.72, 95% CI 0.70-0.75). The same variables were included in the final expectant management model (AUROC 0.70, 95% CI 0.67-0.72). Across the range of predicted probability deciles derived from the elective induction of labor model, almost all women who underwent elective induction of labor at 39 weeks of gestation had a higher observed chance of vaginal delivery than expectant management.
CONCLUSION


Irrespective of the individual predicted chance of vaginal delivery from elective induction of labor at 39 weeks of gestation, vaginal delivery is generally more frequent if elective induction of labor is undertaken rather than expectant management. These data can be used to counsel nulliparous women regarding their ""customized"" chances of vaginal delivery as they choose between elective induction of labor or expectant management at 39 weeks of gestation.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT01990612.",2020,"Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group (P=.005).","['Nulliparous Women at 39 Weeks of Gestation', 'counsel nulliparous women', 'low-risk, nulliparous women contemplating elective induction of labor or expectant management at 39 weeks of gestation', 'low-risk nulliparous women', '6,106 women enrolled in the trial', 'Two groups were included for this analysis: 1) women who were randomized to the induction of labor group and underwent elective induction at 39 0/7-39 4/7 weeks of gestation and 2) women who were randomized to the']","['Vaginal Delivery With Induction of Labor and Expectant Management', 'expectant management group who experienced spontaneous labor or medically indicated delivery (including postterm', 'expectant management', 'planned elective induction of labor']","['Vaginal delivery', 'chance of vaginal delivery']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0474461', 'cui_str': 'Spontaneous onset of labor'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}]",6106.0,0.0517142,"Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group (P=.005).","[{'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': ""Departments of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah, Northwestern University, Chicago, Illinois, University of Alabama at Birmingham, Birmingham, Alabama, Stanford University, Stanford, California, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Texas Medical Branch, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Texas Southwestern Medical Center, Dallas, Texas, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado, University of Pennsylvania, Philadelphia, Pennsylvania, Duke University, Durham, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, and Washington University in St. Louis, St. Louis, Missouri; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.""}, {'ForeName': 'Madeline Murguia', 'Initials': 'MM', 'LastName': 'Rice', 'Affiliation': ''}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': ''}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': ''}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mallett', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': ''}, {'ForeName': 'Yasser Y', 'Initials': 'YY', 'LastName': 'El-Sayed', 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': ''}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': ''}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': ''}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': ''}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Gibbs', 'Affiliation': ''}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': ''}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': ''}, {'ForeName': 'Hyagriv N', 'Initials': 'HN', 'LastName': 'Simhan', 'Affiliation': ''}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004046']
1640,32865377,Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure.,"BACKGROUND


Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure in patients regardless of the presence or absence of diabetes. More evidence is needed regarding the effects of these drugs in patients across the broad spectrum of heart failure, including those with a markedly reduced ejection fraction.
METHODS


In this double-blind trial, we randomly assigned 3730 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive empagliflozin (10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of cardiovascular death or hospitalization for worsening heart failure.
RESULTS


During a median of 16 months, a primary outcome event occurred in 361 of 1863 patients (19.4%) in the empagliflozin group and in 462 of 1867 patients (24.7%) in the placebo group (hazard ratio for cardiovascular death or hospitalization for heart failure, 0.75; 95% confidence interval [CI], 0.65 to 0.86; P<0.001). The effect of empagliflozin on the primary outcome was consistent in patients regardless of the presence or absence of diabetes. The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.70; 95% CI, 0.58 to 0.85; P<0.001). The annual rate of decline in the estimated glomerular filtration rate was slower in the empagliflozin group than in the placebo group (-0.55 vs. -2.28 ml per minute per 1.73 m 2  of body-surface area per year, P<0.001), and empagliflozin-treated patients had a lower risk of serious renal outcomes. Uncomplicated genital tract infection was reported more frequently with empagliflozin.
CONCLUSIONS


Among patients receiving recommended therapy for heart failure, those in the empagliflozin group had a lower risk of cardiovascular death or hospitalization for heart failure than those in the placebo group, regardless of the presence or absence of diabetes. (Funded by Boehringer Ingelheim and Eli Lilly; EMPEROR-Reduced ClinicalTrials.gov number, NCT03057977.).",2020,"The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.70; 95% CI, 0.58 to 0.85; P<0.001).","['patients regardless of the presence or absence of diabetes', '3730 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive', 'Heart Failure', 'patients receiving recommended therapy for heart failure, those in the']","['Sodium-glucose cotransporter 2 (SGLT2) inhibitors', 'Empagliflozin', 'empagliflozin', 'placebo']","['presence or absence of diabetes', 'Cardiovascular and Renal Outcomes', 'lower risk of serious renal outcomes', 'cardiovascular death or hospitalization for heart failure', 'glomerular filtration rate', 'Uncomplicated genital tract infection', 'composite of cardiovascular death or hospitalization for worsening heart failure', 'total number of hospitalizations for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C2314882', 'cui_str': 'Genital Tract Infections'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",3730.0,0.648207,"The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.70; 95% CI, 0.58 to 0.85; P<0.001).","[{'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Carson', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Januzzi', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tsutsui', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Waheed', 'Initials': 'W', 'LastName': 'Jamal', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Schnee', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Zeller', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cotton', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Edimar', 'Initials': 'E', 'LastName': 'Bocchi', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Dong-Ju', 'Initials': 'DJ', 'LastName': 'Choi', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Chopra', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Chuquiure', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Giannetti', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janssens', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Gonzalez Juanatey', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Kaul', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Brunner-La Rocca', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Perrone', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Ileana', 'Initials': 'I', 'LastName': 'Pina', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Marie-France', 'Initials': 'MF', 'LastName': 'Seronde', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Jindrich', 'Initials': 'J', 'LastName': 'Spinar', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Squire', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Taddei', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2022190']
1641,32911210,Factors affecti̇ng health-promoti?ng behavi̇ors i̇n nursi̇ng students: A structural equation modeling approach.,"BACKGROUND


The purpose of this study is to evaluate the effectiveness of the Mindfulness-based Stress Reduction program applied to a sample of Turkish nursing students.
METHOD


The study was designed as a randomized controlled trial. Program sessions of 90-95 minutes were given twice a week for 12 weeks. The data were collected using the Nursing Education Stress Scale, the Mindfulness Scale, and the Stress Management Styles Scale.
RESULTS


A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions. On the Mindfulness Scale, a statistically significant difference was found between the mean pre-test and post-test scores obtained by the experiment and control groups.
CONCLUSION


The results derived from this study suggest that the mindfulness-based stress reduction program is effective in reducing the stress experienced by students during nursing education, increasing their mindfulness, strengthening their coping mechanisms for stress, increasing their use of self-confident and optimistic approaches, and decreasing their use of the helpless approach.",2020,A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions.,"['Factors affecti̇ng health-promoti?ng behavi̇ors i̇n nursi̇ng students', 'Turkish nursing students']","['mindfulness-based stress reduction program', 'Mindfulness-based Stress Reduction program']","['Nursing Education Stress Scale, the Mindfulness Scale, and the Stress Management Styles Scale', 'Nursing Education Stress Scale']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0013636', 'cui_str': 'Nursing Education'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]",95.0,0.0107001,A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Yıldırım Şişman', 'Affiliation': 'DuzceUniversity, Facultyof Health Sciences, Department of Nursing, Duzce, Turkey. Electronic address: nuriyeyildirim@duzce.edu.tr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karaca', 'Affiliation': 'DuzceUniversity, Facultyof Health Sciences, Department of Nursing, Duzce, Turkey. Electronic address: ayselkaraca@duzce.edu.tr.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cangür', 'Affiliation': 'DuzceUniversity, Faculty of Medicine, Department of Biostatistics and Medical Informatics, Duzce, Turkey. Electronic address: sengulcangur@duzce.edu.tr.'}]",Nurse education in practice,['10.1016/j.nepr.2020.102880']
1642,32905863,Behavioral and neurological effects of tDCS on speech motor recovery: A single-subject intervention study.,"This paper reports a feasibility study designed to evaluate the behavioral and neurological effects of using transcranial direct current stimulation (tDCS) in conjunction with speech motor learning treatment for individuals with acquired speech impairment subsequent to stroke. Most of the research using tDCS to enhance treatment outcomes in stroke recovery has focused on either limb motor control or aphasia treatment. Using a multiple-baseline multiple-probe crossover design, we compared both behavioral and brain connectivity-based outcomes following speech motor learning treatment with both Active tDCS and Sham tDCS. We observed that both treatment phases led to improvement in short-term maintenance, but that Active tDCS was associated with greater long-term maintenance improvement. Active tDCS was also associated with an increase in functional connectivity in the left hemisphere and interhemispherically in an ROI-based network analysis examining correlations among areas associated with speech production and acquired speech impairment. This report supports the possibility that tDCS may enhance both behavioral and neurological outcomes and indicates the importance of additional work in this area, although replication is required to confirm the extent and consistency of tDCS benefits on speech motor learning treatment outcomes.",2020,Active tDCS was also associated with an increase in functional connectivity in the left hemisphere and interhemispherically in an ROI-based network analysis examining correlations among areas associated with speech production and acquired speech impairment.,['individuals with acquired speech impairment subsequent to stroke'],"['speech motor learning treatment with both Active tDCS and Sham tDCS', 'transcranial direct current stimulation (tDCS', 'tDCS', 'speech motor learning treatment']","['functional connectivity', 'speech motor recovery']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0037822', 'cui_str': 'Speech disorder'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]",,0.0164864,Active tDCS was also associated with an increase in functional connectivity in the left hemisphere and interhemispherically in an ROI-based network analysis examining correlations among areas associated with speech production and acquired speech impairment.,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Buchwald', 'Affiliation': 'New York University, Department of Communicative Sciences and Disorders, 665 Broadway Suite 900, New York, NY 10012, USA. Electronic address: buchwald@nyu.edu.'}, {'ForeName': 'Nicolette', 'Initials': 'N', 'LastName': 'Khosa', 'Affiliation': 'New York University, Department of Communicative Sciences and Disorders, 665 Broadway Suite 900, New York, NY 10012, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Rimikis', 'Affiliation': 'New York University, Department of Communicative Sciences and Disorders, 665 Broadway Suite 900, New York, NY 10012, USA.'}, {'ForeName': 'E Susan', 'Initials': 'ES', 'LastName': 'Duncan', 'Affiliation': 'Louisiana State University, Department of Communication Sciences and Disorders, 68 Hatcher Hall, Baton Rouge, LA 70803, USA.'}]",Brain and language,['10.1016/j.bandl.2020.104849']
1643,32903261,Impact of a pre-feeding oral stimulation program on first feed attempt in preterm infants: Double-blind controlled clinical trial.,"OBJECTIVE


To evaluate the effect of an oral stimulation program in preterm on the performance in the first oral feeding, oral feeding skills and transition time from tube to total oral intake.
STUDY DESIGNER


Double-blind randomized clinical trial including very preterm newborns. Congenital malformations, intracranial hemorrhage grade III or IV, bronchopulmonary dysplasia, and necrotizing enterocolitis were excluded. Intervention group (GI) received an oral stimulation program of tactile extra-, peri-, and intraoral tactile manipulation once a day for 15 minutes, during a 10-day period. Control group (GII) received sham procedure with same duration of time. Feeding ability was assessed by a speech-language pathologist blinded to group assignment. The classification of infants' oral performance was determined by Oral Feeding Skills (OFS). Neonates were monitored until hospital discharge.
RESULTS


Seventy-four (37 in each group) were randomized. Mean gestational ages and birth weights were 30±1.4 and 30±1.5 weeks, and 1,452±330g and 1,457±353g for intervention and control groups, respectively. Infants in the intervention group had significantly better rates than infants in the control group on: mean proficiency (PRO) (41.5%±18.3 vs. 19.9%±11.6 (p<0.001)), transfer rate (RT) (2.3 mL/min and 1.1 mL/min (p<0.001)) and overall transfer (OT) (57.2%±19.7 and 35.0%±15.7 (p<0.001)). Median transition time from tube to oral feeding was 4 (3-11) and 8 (7-13) days in intervention and control groups, respectively (p = 0.003). Intake of breast milk was found to reduce transition time from tube feeds to exclusive oral feeding (p<0.001, HR 1.01, 95%CI 1.005-1.019), but the impact of the study intervention remained significant (p = 0.007, HR 1.97, 95%CI 1.2-3.2).
CONCLUSION


Infants who were breast-fed and an oral stimulation program proved beneficial in reducing transition time from tube feeding to oral feeding.
TRIAL REGISTRATION


ClinicalTrials.gov number NCT03025815.",2020,"Intake of breast milk was found to reduce transition time from tube feeds to exclusive oral feeding (p<0.001, HR 1.01, 95%CI 1.005-1.019), but the impact of the study intervention remained significant (p = 0.007, HR 1.97, 95%CI 1.2-3.2).
","['preterm infants', 'very preterm newborns', 'Seventy-four (37 in each group) were randomized']","['Intervention group (GI) received an oral stimulation program of tactile extra-, peri-, and intraoral tactile manipulation', 'oral stimulation program', 'pre-feeding oral stimulation program']","['transition time', 'Mean gestational ages and birth weights', 'Median transition time from tube to oral feeding', 'overall transfer (OT', 'Feeding ability', 'mean proficiency (PRO', 'transfer rate (RT', 'Congenital malformations, intracranial hemorrhage grade III or IV, bronchopulmonary dysplasia, and necrotizing enterocolitis', 'better rates']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0429944', 'cui_str': 'Feeding ability'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",,0.179173,"Intake of breast milk was found to reduce transition time from tube feeds to exclusive oral feeding (p<0.001, HR 1.01, 95%CI 1.005-1.019), but the impact of the study intervention remained significant (p = 0.007, HR 1.97, 95%CI 1.2-3.2).
","[{'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'da Rosa Pereira', 'Affiliation': 'Department of Speech-Language Pathology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Deborah Salle', 'Initials': 'DS', 'LastName': 'Levy', 'Affiliation': 'Department of Speech-Language Pathology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Renato S', 'Initials': 'RS', 'LastName': 'Procianoy', 'Affiliation': 'Department of Pediatrics, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Rita C', 'Initials': 'RC', 'LastName': 'Silveira', 'Affiliation': 'Department of Pediatrics, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.'}]",PloS one,['10.1371/journal.pone.0237915']
1644,32917847,Positive End-Expiratory Pressure in Newborn Resuscitation Around Term: A Randomized Controlled Trial.,"BACKGROUND


International guidelines for resuscitation recommend using positive end-expiratory pressure (PEEP) during ventilation of preterm newborns. Reliable PEEP-valves for self-inflating bags have been lacking, and effects of PEEP during resuscitation of term newborns are insufficiently studied. The objective was to determine if adding a new PEEP valve to the bag-mask during resuscitation of term and near-term newborns could improve heart rate response.
METHODS


This randomized controlled trial was performed at Haydom Lutheran Hospital in Tanzania (September 2016 to June 2018). Helping Babies Breathe-trained midwives performed newborn resuscitation using self-inflating bags with or without a new, integrated PEEP valve. All live-born newborns who received bag-mask ventilation at birth were eligible. Heart rate response measured by ECG was the primary outcome, and clinical outcome and ventilation data were recorded.
RESULTS


Among 417 included newborns (median birth weight 3200 g), 206 were ventilated without and 211 with PEEP. We found no difference in heart rate response. Median (interquartile range) measured PEEP in the PEEP group was 4.7 (2.0-5.6) millibar. The PEEP group received lower tidal volumes (4.9 [1.9-8.2] vs 6.3 [3.9-10.5] mL/kg;  P  = .02) and had borderline lower expired CO 2  (2.9 [1.5-4.3] vs 3.3 [1.9-5.0] %;  P  = .05). Twenty four-hour mortality was 9% in both groups.
CONCLUSIONS


We found no evidence for improved heart rate response during bag-mask ventilation with PEEP compared with no PEEP. The PEEP valve delivered a median PEEP within the intended range. The findings do not support routine use of PEEP during resuscitation of newborns around term.",2020,"Twenty four-hour mortality was 9% in both groups.
","['Newborn Resuscitation', '417 included newborns (median birth weight 3200 g), 206 were ventilated without and 211 with PEEP', 'Haydom Lutheran Hospital in Tanzania (September 2016 to June 2018', 'preterm newborns']","['PEEP', 'bag-mask ventilation', 'newborn resuscitation using self-inflating bags with or without a new, integrated PEEP valve']","['clinical outcome and ventilation data', 'Heart rate response', 'heart rate response', 'lower tidal volumes']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C5191297', 'cui_str': '417'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0337738', 'cui_str': 'Lutheran Church'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]","[{'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}]",,0.307533,"Twenty four-hour mortality was 9% in both groups.
","[{'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Holte', 'Affiliation': 'Department of Pediatrics and Adolescence Medicine, Østfold Hospital Trust, Grålum, Norway; kari.holte@so-hf.no.'}, {'ForeName': 'Hege', 'Initials': 'H', 'LastName': 'Ersdal', 'Affiliation': 'Faculty of Health Sciences, University of Stavanger, Stavanger, Norway.'}, {'ForeName': 'Joar', 'Initials': 'J', 'LastName': 'Eilevstjønn', 'Affiliation': 'Strategic Research Department, Laerdal Medical, Stavanger, Norway.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Gomo', 'Affiliation': 'Strategic Research Department, Laerdal Medical, Stavanger, Norway.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Klingenberg', 'Affiliation': 'Department of Pediatrics and Adolescence Medicine, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Thallinger', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Vestre Viken Hospital Trust, Bærum, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Linde', 'Affiliation': 'Faculty of Health Sciences, University of Stavanger, Stavanger, Norway.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Stigum', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Yeconia', 'Affiliation': 'Haydom Lutheran Hospital, Mbulu, Manyara, Tanzania; and.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Kidanto', 'Affiliation': 'Research, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Ketil', 'Initials': 'K', 'LastName': 'Størdal', 'Affiliation': 'Department of Pediatrics and Adolescence Medicine, Østfold Hospital Trust, Grålum, Norway.'}]",Pediatrics,['10.1542/peds.2020-0494']
1645,32916181,The effects of an exercise training on steroid hormones in preadolescent children - a moderator for enhanced cognition?,"OBJECTIVE


Research demonstrates a variety of cognitive benefits induced by different chronic physiological stressors (e.g. motor vs. cardiovascular exercise training) and acute exercise to affect steroid hormone secretion, the present study aims to investigate 1.) motor vs. cardiovascular exercise training and their impact on salivary Testosterone, Estradiol and Progesterone and 2.) whether alterations in steroid hormones might moderate exercise-induced cognitive benefits.
METHODS


In a randomized control trial, 71 preadolescent children (39 girls) at the age of 9-10 years were randomly assigned to a cardiovascular exercise group (CE), a motor exercise group (ME) as well as a control group (CON) in which students were attending assisted homework. The participants attended their program three times per week, for a total of 10 weeks. Steroid hormones in the saliva, working memory performance and state-trait anxiety levels were determined before and after the intervention.
RESULTS


Statistical analysis showed no chronic changes in hormones through the interventions. Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014). Within the ME, increases of Testosterone from t 1  to t 2  were predicting higher working memory performance post-intervention (β = 0.45, R 2  = 0.16, p = 0.038).
CONCLUSION


Our findings suggest 1.) that motor-exercise-induced cognitive benefits are moderated by changes in Testosterone and 2.) that a 10-week exercise training of moderate intensity and with a motor demanding vs a cardiovascular character does not affect the chronic concentration of salivary Testosterone, Estradiol and Progesterone nor anxiety levels in preadolescent children.",2020,"Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014).","['preadolescent children', '71 preadolescent children (39 girls) at the age of 9-10 years']","['cardiovascular exercise group (CE), a motor exercise group (ME) as well as a control group (CON', 'exercise training', 'motor vs. cardiovascular exercise training']","['salivary Testosterone, Estradiol and Progesterone and 2', 'saliva, working memory performance and state-trait anxiety levels', 'Testosterone', 'steroid hormones', 'chronic concentration of salivary Testosterone, Estradiol and Progesterone nor anxiety levels']","[{'cui': 'C1444711', 'cui_str': 'Pre-teen'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0301818', 'cui_str': 'Steroid hormone'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",71.0,0.0658097,"Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014).","[{'ForeName': 'Davin P', 'Initials': 'DP', 'LastName': 'Akko', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany; Faculty of Humanities and Social Sciences, University of Hagen, Hagen, Germany. Electronic address: davin-patrick.akko@fernuni-hagen.de.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Koutsandréou', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Murillo-Rodríguez', 'Affiliation': 'Escuela de Medicina, División Ciencias de la Salud, Universidad Anáhuac Mayab Mérida, Mérida, Yucatán, Mexico.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Wegner', 'Affiliation': 'Department of Sport Psychology, Institute of Sports Science, Humboldt University Berlin, Berlin, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Budde', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113168']
1646,32916236,"Radiation-induced lymphopenia during chemoradiation therapy for non-small cell lung cancer is linked with age, lung V5, and XRCC1 rs25487 genotypes in lymphocytes.","BACKGROUND & PURPOSE


We investigated clinical and genetic factors associated with severe radiation-induced lymphopenia (RIL) in a randomized clinical trial of photon vs. proton radiation, with chemotherapy, for non-small cell lung cancer.
METHODS


XRCC1 rs25487 was genotyped in lymphocytes from serial peripheral blood samples. Severe RIL was defined as absolute lymphocyte count (ALC) < 0.3 × 10 9  cells/L. Univariate and multivariate analyses were used to identify independent risk factors, which were then used to group patients for risk of severe RIL.
RESULTS


Univariate analysis of the 178 patients in this analysis showed that older age, larger tumors, higher lung V5 and mean lung dose, and higher heart V5 and mean heart dose were associated with severe RIL during treatment (P < 0.05). The XRCC1 rs25487 AA genotype was also associated with increased risk of severe RIL during treatment (AA vs. others: hazard ratio [HR] = 1.665, 95% confidence interval [CI] 1.089-2.500, P = 0.018). Multivariate analyses showed that older age (HR = 1.031, 95% CI 1.009-1.054, P = 0.005), lung V5 (HR = 1.039, 95% CI 1.023-1.055, P < 0.0001), and AA genotype (AA vs. others, HR = 1.768, 95% CI 1.165-2.684, P = 0.007) were independently associated with higher incidence of severe RIL. These three risk factors (age ≥ 56 years, lung V5 ≥ 51% and XRCC1 rs25487 AA) distinguished patients at different risk of developing severe RIL (P < 0.0001).
CONCLUSIONS


Age, lung V5 and XRCC1 rs25487 AA were all linked with risk of severe RIL. Our predictive risk model may be helpful for identifying patients at high risk of severe RIL so that treatment can be modified.",2020,"Multivariate analyses showed that older age (HR=1.031, 95% CI 1.009-1.054, P=0.005), lung V5 (HR=1.039, 95% CI 1.023-1.055, P<0.001), and AA genotype (AA vs. others, HR=1.768, 95% CI 1.165-2.684, P=0.007) were independently associated with higher incidence of severe RIL.",['XRCC1 rs25487 was genotyped in lymphocytes from serial peripheral blood samples'],"['Radiation-induced lymphopenia during chemoradiation therapy', 'photon vs. proton radiation, with chemotherapy']","['lung V5', 'Severe RIL', 'severe RIL', 'absolute lymphocyte count (ALC', 'risk of severe RIL']","[{'cui': 'C0250029', 'cui_str': 'XRCC1 protein, human'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0086805', 'cui_str': 'Photon'}, {'cui': 'C0033727', 'cui_str': 'Proton'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",178.0,0.0968706,"Multivariate analyses showed that older age (HR=1.031, 95% CI 1.009-1.054, P=0.005), lung V5 (HR=1.039, 95% CI 1.023-1.055, P<0.001), and AA genotype (AA vs. others, HR=1.768, 95% CI 1.165-2.684, P=0.007) were independently associated with higher incidence of severe RIL.","[{'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Hunan Key Laboratory of Translational Radiation Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Welsh', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Hekun', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Hunan Key Laboratory of Translational Radiation Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Radhe', 'Initials': 'R', 'LastName': 'Mohan', 'Affiliation': 'Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: TXu@mdanderson.org.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.09.002']
1647,32918907,Forced and Voluntary Aerobic Cycling Interventions Improve Walking Capacity in Individuals With Chronic Stroke.,"OBJECTIVES


To determine the efficacy of high-intensity cycling to improve walking capacity in individuals with chronic stroke, identify variables that predict improvement in walking capacity, and quantify the relationship between the 6-minute walk test (6MWT) and cardiopulmonary exercise (CPX) test variables.
DESIGN


Secondary analysis of data from 2 randomized controlled trials.
SETTING


Research laboratory.
PARTICIPANTS


Individuals with chronic stroke (N=43).
INTERVENTIONS


Participants were randomized to 1 of the following time-matched interventions, occurring 3 times per week for 8 weeks: (1) forced aerobic exercise and upper extremity repetitive task practice (FE+RTP [n=16]), (2) voluntary aerobic exercise and upper extremity repetitive task practice (VE+RTP [n=14]), or (3) a non-aerobic control group (n=13).
MAIN OUTCOME MEASURE


Change in walking capacity as measured by the 6MWT from baseline to the end of treatment (EOT).
RESULTS


Significant increases were observed in distance traveled during the 6MWT at the EOT compared with baseline in the FE+RTP (P<.001) and VE+RTP (P<.001) groups, but not in the control group (P=.21). Among aerobic exercise participants, a multivariate regression analysis revealed that cycling cadence, power output, and baseline 6MWT distance were significant predictors of change in walking capacity.
CONCLUSIONS


An 8-week aerobic cycling intervention prescribed at 60% to 80% of heart rate reserve and moderate to high cadence and resistance led to significant improvements in walking capacity in our cohort of individuals with chronic stroke. Individuals with low baseline walking capacity levels may benefit most from aerobic cycling to improve over ground locomotion. Although the 6MWT did not elicit a cardiorespiratory response comparable to the maximal exertion CPX test, the 6MWT can be considered a valid and clinically relevant submaximal test of cardiorespiratory function in individuals with chronic stroke.",2020,"RESULTS


Significant increases were observed in distance traveled during the 6MWT at EOT compared to baseline in the FE+RTP (p<0.001) and VE+RTP (p<0.001) groups, but not in the control group (p=0.21).","[' Individuals with chronic stroke (N=43', 'persons with chronic stroke', 'individuals with chronic stroke']","['6MWT', 'FE+RTP', 'Forced and voluntary aerobic cycling interventions', 'forced aerobic exercise and upper extremity repetitive task practice (FE+RTP, N=16), 2) voluntary aerobic exercise and upper extremity repetitive task practice (VE+RTP, N=14), or 3) a non-aerobic control group (control, N=13', 'aerobic exercise', 'aerobic cycling intervention']","['Change in walking capacity as measured by the 6MWT from baseline to end of treatment (EOT', 'Six Minute Walk Test (6MWT) and Cardiopulmonary Exercise (CPX) Test variables', 'cycling cadence, power output, and baseline 6MWT distance', 'walking capacity', 'distance traveled']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040802', 'cui_str': 'Travel'}]",,0.0933234,"RESULTS


Significant increases were observed in distance traveled during the 6MWT at EOT compared to baseline in the FE+RTP (p<0.001) and VE+RTP (p<0.001) groups, but not in the control group (p=0.21).","[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Linder', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Cleveland Clinic, Cleveland, OH; Department of Biomedical Engineering, Cleveland Clinic, Cleveland, OH; Concussion Center, Cleveland Clinic, Cleveland, OH. Electronic address: linders@ccf.org.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Davidson', 'Affiliation': 'Concussion Center, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Anson', 'Initials': 'A', 'LastName': 'Rosenfeldt', 'Affiliation': 'Department of Biomedical Engineering, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Mandy Miller', 'Initials': 'MM', 'LastName': 'Koop', 'Affiliation': 'Department of Biomedical Engineering, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Bethoux', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Jay L', 'Initials': 'JL', 'LastName': 'Alberts', 'Affiliation': 'Department of Biomedical Engineering, Cleveland Clinic, Cleveland, OH; Concussion Center, Cleveland Clinic, Cleveland, OH; Center for Neurologic Restoration, Cleveland Clinic, Cleveland, OH.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.08.006']
1648,32919015,The effect of 12-week resistance exercise training on serum levels of cellular aging process parameters in elderly men.,"BACKGROUND


Regular physical activity has a positive effect on the prevention of cellular aging. The present study investigated the effect of 12-week resistance training (RT) on serum levels of Sirtuin-1 (SIRT1), Sirtuin-3 (SIRT3), Sirtuin-6 (SIRT6), Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC1-α), and telomerase enzyme in elderly men.
METHODS


For this purpose, 30 elderly men (age 66.23 ± 0.57 years) were randomly divided into two groups: resistance training group (RET, n = 15) and control group (CTR, n = 15). Participants in RET performed RT protocols with intensity of 60% one-repetition maximum (3×/week, 4 sets of the six exercise circuits). Body composition, physical functioning and, blood samples were assessed before (pre-test) and after (post-test) a 12-week intervention.
RESULTS


The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET. Also, we found a significant difference between the RET and CTR in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.037), PGC1-α (P = 0.007), and telomerase enzyme (P = 0.001).
CONCLUSIONS


12-Week RT increased the levels of proteins associated with the biological aging process in elderly men. It seems that the RT may have beneficial effects on cellular senescence and also improved impaired mitochondrial protein and enzymatic functional induced aging.",2020,"The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET.","['elderly men', '30 elderly men (age 66.23\u202f±\u202f0.57\u202fyears']","['12-week resistance training (RT', 'resistance exercise training', 'resistance training group (RET, n\u202f=\u202f15) and control group (CTR']","['PGC1-α', 'RET and CTR in serum levels of SIRT1', 'SIRT6', 'telomerase enzyme', 'serum levels of Sirtuin-1 (SIRT1), Sirtuin-3 (SIRT3), Sirtuin-6 (SIRT6), Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC1-α), and telomerase enzyme', 'SIRT3', 'serum levels of SIRT1', 'Body composition, physical functioning and, blood samples']","[{'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2720167', 'cui_str': 'Sirt1'}, {'cui': 'C1136177', 'cui_str': 'Silent Mating Type Information Regulator 2-like Proteins'}, {'cui': 'C0087071', 'cui_str': 'Telomerase Reverse Transcriptase'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C2720169', 'cui_str': 'Sirt3'}, {'cui': 'C1452082', 'cui_str': 'PPARGC1A protein, human'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",30.0,0.0157346,"The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET.","[{'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Hooshmand-Moghadam', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran; Department of Exercise Physiology, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Eskandari', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Golestani', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Rezae', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Mahmoudi', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Gaeini', 'Affiliation': 'Department of Exercise Physiology, University of Tehran, Tehran, Iran. Electronic address: aagaeini@ut.ac.ir.'}]",Experimental gerontology,['10.1016/j.exger.2020.111090']
1649,32920498,Ocrelizumab Treatment in Patients with Primary Progressive Multiple Sclerosis: Short-term Safety Results from a Compassionate Use Programme in Germany.,"OBJECTIVES


In January 2018, the European Union (EU) approved ocrelizumab in relapsing multiple sclerosis (RMS) and as the first disease-modifying therapy (DMT) for patients with primary progressive multiple sclerosis (PPMS) with efficacy proven in a phase 3 randomised controlled trial. Eleven months prior to the European regulatory approval, a compassionate use programme (CUP) made ocrelizumab available to 489 patients with PPMS in Germany, thereby for the first time providing a therapeutic option to patients with PPMS who could not participate in ocrelizumab studies. Here, we report real-world patient characteristics and short-term safety data of patients with PPMS treated with ocrelizumab in this CUP.
PATIENTS AND METHODS


This CUP was initiated in February 2017 - shortly before US Food and Drug administration approval in March 2017 - and ended in January 2018, following ocrelizumab approval in the EU. Adult patients (age ≥18 years) with PPMS who had a positive benefit/risk ratio according to the treating physician were eligible for inclusion at German treatment centres. The main exclusion criteria were current/recent treatment with other immune therapies and unresolved/chronic/active infections. Patients received methylprednisolone and an antihistamine before treatment with intravenous ocrelizumab in 6-month cycles. The first ocrelizumab dose was a 300 mg infusion followed by a second 300 mg infusion 2 weeks later; subsequent doses were delivered as a single 600 mg infusion. Adverse events were reported immediately.
RESULTS


Of 580 requests received from 104 centres, 525 patients met the eligibility criteria. Thirty-five patients did not participate due to withdrawal by the treating physician, and one due to death prior to treatment. A total of 489 patients received at least one 600 mg dose of ocrelizumab (administered as two 300 mg infusions) and 51 received a second dose. Due to termination of the CUP upon marketing authorisation, the maximum follow-up period was 12 months. Median patient age was 52 years (range: 24-73), and 49% were female. Previous immunomodulatory or immunosuppressive therapies had been received by 41% of patients, with the most commonly used being glucocorticoids, mitoxantrone, interferon-β and glatiramer acetate. Patients with a previous malignancy, serious disease or infection (42 patients, 9%) had recovered from this prior to the CUP. Nine serious adverse events and 70 non-serious adverse events were reported in 40 patients. Adverse event categories were generally consistent with the known safety profile of ocrelizumab; one patient had carry-over progressive multifocal leukoencephalopathy (PML) due to previous natalizumab treatment.
CONCLUSION


This CUP provides first real-world observations of ocrelizumab for the treatment of PPMS in a large patient cohort in Germany, supporting that ocrelizumab is generally well-tolerated in clinical practice. Physicians should be vigilant for early symptoms of PML, as to date, 9 PML cases that were all confounded have been reported in patients treated with ocrelizumab worldwide, with 8 carry-over cases from a prior DMT.",2020,"Previous immunomodulatory or immunosuppressive therapies had been received by 41% of patients, with the most commonly used being glucocorticoids, mitoxantrone, interferon-β and glatiramer acetate.","['489 patients with PPMS in Germany', '489 patients', 'Patients with Primary Progressive Multiple Sclerosis', '525 patients met the eligibility criteria', 'patients with primary progressive multiple sclerosis (PPMS', 'Adult patients (age ≥18 years) with PPMS who had a positive benefit/risk ratio according to the treating physician were eligible for inclusion at German treatment centres', 'patients with PPMS treated with ocrelizumab in this CUP', 'patients with PPMS who could not participate in ocrelizumab studies', 'Patients with a previous malignancy, serious disease or infection (42 patients, 9%) had recovered from this prior to the CUP', 'Of 580 requests received from 104 centres', 'Median patient age was 52 years (range: 24-73), and 49% were female', 'This CUP was initiated in February 2017 - shortly before US Food and Drug administration approval in March 2017 - and ended in January 2018, following ocrelizumab approval in the EU']","['ocrelizumab', 'methylprednisolone', 'intravenous ocrelizumab', 'glucocorticoids, mitoxantrone, interferon-β and glatiramer acetate', 'antihistamine', 'Ocrelizumab']",['Adverse events'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751964', 'cui_str': 'Primary progressive multiple sclerosis'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C2718016', 'cui_str': 'Compassionate Use'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C4517818', 'cui_str': '580'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015179', 'cui_str': 'European Community'}]","[{'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0289884', 'cui_str': 'glatiramer acetate'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]",489.0,0.02963,"Previous immunomodulatory or immunosuppressive therapies had been received by 41% of patients, with the most commonly used being glucocorticoids, mitoxantrone, interferon-β and glatiramer acetate.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Rauer', 'Affiliation': 'Klinik für Neurologie und Neurophysiologie, Universitätsklinikum Freiburg, Freiburg, Germany. Electronic address: sebastian.rauer@uniklinik-freiburg.de.'}, {'ForeName': 'Muna-Miriam', 'Initials': 'MM', 'LastName': 'Hoshi', 'Affiliation': 'Neurologische Klinik, Technische Universität München, Munich, Germany. Electronic address: muna.hoshi@ms-klinik.de.'}, {'ForeName': 'Refik', 'Initials': 'R', 'LastName': 'Pul', 'Affiliation': 'Klinik für Neurologie, Universitätsklinikum Essen, Essen, Germany. Electronic address: refik.pul@uk-essen.de.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Wahl', 'Affiliation': 'Zentrum der Neurologie und Neurochirugie, Universitätsklinikum Frankfurt, Frankfurt, Germany. Electronic address: wahl@med.uni-frankfurt.de.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schwab', 'Affiliation': 'Klinik für Neurologie, Universitätsklinikum Jena, Jena, Germany. Electronic address: matthias.schwab@med.uni-jena.de.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Haas', 'Affiliation': 'Jüdisches Krankenhaus Berlin, Berlin, Germany. Electronic address: judith.haas@jkb-online.de.'}, {'ForeName': 'Gisa', 'Initials': 'G', 'LastName': 'Ellrichmann', 'Affiliation': 'Klinik für Neurologie, St. Josef-Hospital, Bochum, Germany. Electronic address: gisa.ellrichmann@rub.de.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Krumbholz', 'Affiliation': 'Department of Neurology & Stroke and Hertie-Institute for Clinical Brain Research, Eberhard Karl University of Tübingen, Tübingen, Germany. Electronic address: markus.krumbholz@uni-tuebingen.de.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Tackenberg', 'Affiliation': 'Zentrum für Neuroimmunologie, Universitätsklinikum Marburg, Marburg, Germany; F. Hoffmann-La Roche AG, Basel, Switzerland. Electronic address: tackenbb@staff.uni-marburg.de.'}, {'ForeName': 'Kai-Uwe', 'Initials': 'KU', 'LastName': 'Saum', 'Affiliation': 'Roche Pharma AG, Grenzach-Wyhlen, Germany. Electronic address: kai-uwe.saum@roche.com.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Buck', 'Affiliation': 'Roche Pharma AG, Grenzach-Wyhlen, Germany. Electronic address: fabian.buck@roche.com.'}, {'ForeName': 'Jost', 'Initials': 'J', 'LastName': 'Leemhuis', 'Affiliation': 'Roche Pharma AG, Grenzach-Wyhlen, Germany. Electronic address: jost.leemhuis@roche.com.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Kretschmann', 'Affiliation': 'Roche Pharma AG, Grenzach-Wyhlen, Germany. Electronic address: anita.kretschmann@roche.com.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Aktas', 'Affiliation': 'Klinik für Neurologie, Medizinische Fakultät, Universitätsklinikum Düsseldorf, Düsseldorf, Germany. Electronic address: orhan.aktas@med.uni-duesseldorf.de.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106142']
1650,32921065,A clinical study on the treatment of granulomatous lobular mastitis by the external application of the internal pus-expelling decoction and operation.,"BACKGROUND


The objective of this study was to evaluate the clinical efficacy of the external application of internal expulsion pus-expelling decoction (IEPED) combined with surgery in the treatment of granulomatous lobular mastitis (GLM).
METHODS


A total of 110 patients in our hospital with sepsis GLM were randomly divided into two groups: treatment group (n=60, the wound was treated with IEPED) and control group (n=50, the wound was not treated with IEPED). We assessed the recurrence, contra lateral breast form, and aesthetic evaluation of the patients in the two groups.
RESULTS


The total effective rates in the patients in the treatment group and the control group were 90% and 68%, respectively, after the preoperative pretreatment and before radical surgery (P<0.05). After 10 days of receiving the debridement treatment, the two groups were compared in term of physical signs scores and the difference was statistically significant (P<0.05). Within one year of the regular follow-up after treatment, 0 case recurred in the treatment group and 1 case recurred in the control group (P>0.05). In the treatment group, 30 cases showed excellent results in the aesthetic evaluation of breast appearance, 18 cases were good, and the overall excellent and good rate was up to 80%. In the control group, 12 cases showed excellent results and 16 cases showed good results, with the overall excellent and good rate reaching 56% (P<0.05).
CONCLUSIONS


In patients with abscess debridement of GLM, the external application of IEPED can significantly reduce the primary lesion of patients with abscess GLM, reduce the surgical resection area, and maximize the preservation of the patients' breast appearance.",2020,"In patients with abscess debridement of GLM, the external application of IEPED can significantly reduce the primary lesion of patients with abscess GLM, reduce the surgical resection area, and maximize the preservation of the patients' breast appearance.","['granulomatous lobular mastitis (GLM', '110 patients in our hospital with sepsis GLM']","['GLM', 'IEPED) and control group (n=50, the wound was not treated with IEPED', 'internal pus-expelling decoction and operation', 'internal expulsion pus-expelling decoction (IEPED) combined with surgery']","['recurrence, contra lateral breast form, and aesthetic evaluation', 'aesthetic evaluation of breast appearance', 'total effective rates', 'overall excellent and good rate']","[{'cui': 'C0439667', 'cui_str': 'Granulomatous'}, {'cui': 'C0205417', 'cui_str': 'Lobular'}, {'cui': 'C0024894', 'cui_str': 'Mastitis'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0439667', 'cui_str': 'Granulomatous'}, {'cui': 'C0205417', 'cui_str': 'Lobular'}, {'cui': 'C0024894', 'cui_str': 'Mastitis'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0034161', 'cui_str': 'Pus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1286083', 'cui_str': 'Form of breast'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1286082', 'cui_str': 'Appearance of breast'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",18.0,0.0159327,"In patients with abscess debridement of GLM, the external application of IEPED can significantly reduce the primary lesion of patients with abscess GLM, reduce the surgical resection area, and maximize the preservation of the patients' breast appearance.","[{'ForeName': 'Peng-Zhou', 'Initials': 'PZ', 'LastName': 'Liu', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Xiao-Guang', 'Initials': 'XG', 'LastName': 'Shi', 'Affiliation': 'Department of Galactophore Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing, China. shixgtcm915@163.com.'}, {'ForeName': 'Xi-Meng', 'Initials': 'XM', 'LastName': 'Zuo', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Lai', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ze', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Zhen-Rui', 'Initials': 'ZR', 'LastName': 'Yang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jie-Li', 'Initials': 'JL', 'LastName': 'Liu', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}]",Annals of palliative medicine,['10.21037/apm-19-684']
1651,32921090,Efficacy of self-heating calf sleeves for preventing deep vein thrombosis in lung cancer patients who undergo video-assisted thoracoscopic surgery lobectomy.,"BACKGROUND


Deep vein thrombosis (DVT) poses a considerable perioperative risk in patients who undergo surgical procedures. This study set out to determine the efficacy of self-heating calf sleeves (SHCSs) in preventing postoperative DVT in lung cancer patients undergoing VATS lobectomy.
METHODS


This study included 557 participants who underwent video-assisted thoracoscopic surgery (VATS) lobectomy between June, 2018 and June, 2019. The participants were randomly divided into two groups: the SHCS group and the control group. SHCS was applied to the patients intraoperatively. Each patient was subjected to Doppler ultrasound and D-dimer examination preoperatively and postoperatively. Signs and symptoms of DVT were monitored daily. Incidences of DVT were compared between the two groups.
RESULTS


Based on Color Doppler ultrasonography performed on day 2 after surgery, 42 of the 276 patients (15.20%) in the control group developed DVT, compared to 12 out of 281 patients (4.27%) in the SHCS group. There was significant difference in the incidence of DVT between the two groups (P<0.0001). The use of SHCSs significantly enhanced venous blood flow compared to when no mechanical prophylaxis was used (P<0.001). No significant difference in plasma D-dimer level was observed between the two groups. No SHCS-related complications occurred in the study.
CONCLUSIONS


This study demonstrate that SHCSs are a satisfactory form of DVT prophylaxis method that can improve venous blood flow and thus alleviate venous stasis in the lower extremities. SHCSs offer a simple, inexpensive, and generally complication-free prophylactic method for lung cancer patients undergoing VATS lobectomy.
TRIAL REGISTRATION


ChiCTR1900022043.",2020,The use of SHCSs significantly enhanced venous blood flow compared to when no mechanical prophylaxis was used (P<0.001).,"['patients who undergo surgical procedures', '557 participants who underwent', 'lung cancer patients undergoing VATS lobectomy', 'lung cancer patients who undergo video-assisted thoracoscopic surgery lobectomy', 'between June, 2018 and June, 2019']","['SHCSs', 'self-heating calf sleeves (SHCSs', 'video-assisted thoracoscopic surgery (VATS) lobectomy', 'SHCS', 'self-heating calf sleeves']","['Signs and symptoms of DVT', 'deep vein thrombosis', 'plasma D-dimer level', 'Incidences of DVT', 'incidence of DVT', 'SHCS-related complications', 'venous blood flow']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C4520228', 'cui_str': 'Thoracoscopic surgical lobectomy using video-assisted guidance'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}]","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}]",557.0,0.0169138,The use of SHCSs significantly enhanced venous blood flow compared to when no mechanical prophylaxis was used (P<0.001).,"[{'ForeName': 'Shenghua', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Operating Room, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Operating Room, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Saiqi', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Operating Room, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. zhaoyunfeng518@126.com.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Operating Room, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. woailuyue0701@126.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1165']
1652,32921096,"Efficacy and safety of HX 110-A and HX 110-B in promoting respiratory health: protocol for an 8-week, randomized, double-blind, parallel group, placebo-controlled trial.","BACKGROUND


HX110-A and HX110-B are compound extracts based on radix adenophorae and rhizoma dioscoreae, respectively, which have anti-inflammatory activity. There are limited data on whether they may help improve respiratory conditions including lung function. Therefore, in this trial, we will evaluate the effectiveness and safety of the use of HX110-A and HX110-B for the treatment of respiratory health in adults with mild respiratory symptoms.
METHODS


This will be an 8-week, randomized, double-blind, parallel group, placebo-controlled trial with three arms. Adults more than 40 years old with persistent respiratory symptoms will be enrolled. Patients with definite respiratory disease or with a history of recent intake of antioxidants or anti-inflammatory agents will be excluded. Study subjects will be assigned at a 1:1:1 ratio into the following three arms: controls, experimental group 1 (HX110-A), and experimental group 2 (HX110-B). Control or experimental foods will be administered for 8 weeks, and follow-up will be up to 12 weeks. The primary outcome will be total antioxidant capacity. Secondary outcomes will be inflammatory indexes, respiratory symptoms, lung function, quality of life, and fatigue level. Safety outcomes will be assessed by monitoring adverse events and vital signs, and through clinical pathology tests.
RESULTS


This trial will reveal the effectiveness and safety of HX110-A and/or HX110-B for medical purposes in adults with respiratory symptoms. The results should clarify if active intake of specific foods with these functional compounds may promote respiratory health in adults without definite respiratory disease.
TRIAL REGISTRATION


Clinical Research Information Service, KCT0003614. Registered 12 May 2019 (Respectively registered, https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=13364).",2020,This trial will reveal the effectiveness and safety of HX110-A and/or HX110-B for medical purposes in adults with respiratory symptoms.,"['adults with mild respiratory symptoms', 'Adults more than 40 years old with persistent respiratory symptoms', 'adults without definite respiratory disease', 'adults with respiratory symptoms', 'Patients with definite respiratory disease or with a history of recent intake of antioxidants or anti-inflammatory agents']","['HX 110-A and HX 110-B', 'HX110-A and HX110-B', 'placebo', 'HX110-A and/or HX110-B']","['Efficacy and safety', 'monitoring adverse events and vital signs, and through clinical pathology tests', 'inflammatory indexes, respiratory symptoms, lung function, quality of life, and fatigue level', 'total antioxidant capacity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0035204', 'cui_str': 'Disorder of respiratory system'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0030667', 'cui_str': 'Clinical Pathology'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]",,0.58787,This trial will reveal the effectiveness and safety of HX110-A and/or HX110-B for medical purposes in adults with respiratory symptoms.,"[{'ForeName': 'Jung-Kyu', 'Initials': 'JK', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea.'}, {'ForeName': 'Bumjo', 'Initials': 'B', 'LastName': 'Oh', 'Affiliation': 'Department of Family Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea.'}, {'ForeName': 'Hyun Woo', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea.'}, {'ForeName': 'Seo-Young', 'Initials': 'SY', 'LastName': 'Yoon', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea.'}, {'ForeName': 'Tae Yun', 'Initials': 'TY', 'LastName': 'Park', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea.'}, {'ForeName': 'Eun Young', 'Initials': 'EY', 'LastName': 'Heo', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea.'}, {'ForeName': 'Deog Kyeom', 'Initials': 'DK', 'LastName': 'Kim', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea. kimdkmd@gmail.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1214']
1653,32924312,Composite restorations placed in non-carious cervical lesions-Which cavity preparation is clinically reliable?,"The purpose of this in-vivo study was to evaluate the clinical performance of restorations placed in non-carious cervical lesions (NCCLs), using different cavity preparation designs, after 7.7 years. A total of 85 NCCLs with coronal margins in enamel and cervical margins in dentin were randomly assigned to the following treatment protocols: dentin surface cleaning, dentin surface roughening with round bur plus flowable composite, dentin surface roughening/cervical groove preparation with round bur, dentin surface roughening/cervical groove preparation with round bur plus flowable composite. After enamel beveling and selective enamel etching, the defects were restored with composite. The restorations were assessed by two independent, calibrated and blinded investigators, using modified USPHS criteria. At 7 years (7.7 (± 0.35)), a total of 64 restorations (75.3%) were available for follow-up examination. The total retention rate, irrespective of the test groups, was 82.8%. Restorations placed without any preparation showed the highest loss rate (27.8%). Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration did not differ significantly between the groups. Composites are long-term stable materials for restoring NCCLs. Restorations placed without any dentin preparation (cavity cleaning only) showed the highest loss rate.",2020,"Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration did not differ significantly between the groups.",['A total of 85 NCCLs with coronal margins in enamel and cervical margins in dentin'],"['dentin surface cleaning, dentin surface roughening with round bur plus flowable composite, dentin surface roughening/cervical groove preparation with round bur, dentin surface roughening/cervical groove preparation with round bur plus flowable composite']","['total retention rate', 'Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration', 'highest loss rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4274086', 'cui_str': 'Non carious lesion at cervical margin of tooth'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0673997', 'cui_str': 'flowable hybrid composite'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0205250', 'cui_str': 'High'}]",85.0,0.0489112,"Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration did not differ significantly between the groups.","[{'ForeName': 'Anne-Katrin', 'Initials': 'AK', 'LastName': 'Lührs', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Jacker-Guhr', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Hüsamettin', 'Initials': 'H', 'LastName': 'Günay', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Herrmann', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}]",Clinical and experimental dental research,['10.1002/cre2.310']
1654,32919517,"Valaciclovir to prevent vertical transmission of cytomegalovirus after maternal primary infection during pregnancy: a randomised, double-blind, placebo-controlled trial.","BACKGROUND


Cytomegalovirus is a common congenital infection, with high morbidity after an early primary maternal infection. No effective means exist to prevent viral transmission to the fetus. We aimed to investigate whether valaciclovir can prevent vertical transmission of cytomegalovirus to the fetus in pregnant women with a primary infection acquired early in pregnancy.
METHODS


This prospective, randomised, double-blind, placebo-controlled trial was done at the Infectious Feto-Maternal Clinic of Rabin Medical Center (Petach Tikvah, Israel). Pregnant women aged 18 years or older, with serological evidence of a primary cytomegalovirus infection acquired either periconceptionally or during the first trimester of pregnancy, were randomly assigned to oral valaciclovir (8 g per day, twice daily) or placebo from enrolment until amniocentesis at 21 or 22 gestational weeks. Randomisation was done separately for participants infected periconceptionally or during the first trimester and was done in blocks of four. Patients and researchers were masked to participant allocation throughout the entire study period. The primary endpoint was the rate of vertical transmission of cytomegalovirus. Statistical analyses were done according to per-protocol principles. The study was registered at ClinicalTrials.gov, NCT02351102.
FINDINGS


Between Nov 15, 2015, and Oct 8, 2018, we enrolled and randomly assigned 100 patients to receive valaciclovir or placebo. Ten patients were excluded, five from each study group; therefore, the final analysis included 45 patients (all singletons) in the valaciclovir group and 45 patients (43 singletons and two sets of twins) in the placebo group. In the valaciclovir group, including both first trimester and periconceptional infections, five (11%) of 45 amniocenteses were positive for cytomegalovirus, compared with 14 (30%) of 47 amniocenteses in the placebo group (p=0·027; odds ratio 0·29, 95% CI 0·09-0·90 for vertical cytomegalovirus transmission). Among participants with a primary cytomegalovirus infection during the first trimester, a positive amniocentesis for cytomegalovirus was significantly less likely in the valaciclovir group (two [11%] of 19 amniocenteses) compared with the placebo group (11 [48%] of 23 amniocenteses; p=0·020. No clinically significant adverse events were reported.
INTERPRETATION


Valaciclovir is effective in reducing the rate of fetal cytomegalovirus infection after maternal primary infection acquired early in pregnancy. Early treatment of pregnant women with primary infection might prevent termination of pregnancies or delivery of infants with congenital cytomegalovirus.
FUNDING


None.",2020,"Early treatment of pregnant women with primary infection might prevent termination of pregnancies or delivery of infants with congenital cytomegalovirus.
","['pregnant women with primary infection might prevent termination of pregnancies or delivery of infants with congenital cytomegalovirus', 'pregnant women with a primary infection acquired early in pregnancy', 'Ten patients were excluded, five from each study group; therefore, the final analysis included 45 patients (all singletons) in the valaciclovir group and 45 patients (43 singletons and two sets of twins) in the placebo group', 'Pregnant women aged 18 years or older, with serological evidence of a primary cytomegalovirus infection acquired either periconceptionally or during the first trimester of pregnancy', 'cytomegalovirus after maternal primary infection during pregnancy', 'Infectious Feto-Maternal Clinic of Rabin Medical Center (Petach Tikvah, Israel', 'Between Nov 15, 2015, and Oct 8, 2018, we enrolled and randomly assigned 100 patients to receive']","['valaciclovir or placebo', 'Valaciclovir', 'valaciclovir', 'placebo', 'oral valaciclovir']","['rate of vertical transmission of cytomegalovirus', 'positive amniocentesis for cytomegalovirus', 'rate of fetal cytomegalovirus infection', 'adverse events']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0948192', 'cui_str': 'Primary infection NOS'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0392535', 'cui_str': 'Termination of pregnancy'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0249458', 'cui_str': 'valacyclovir'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0249458', 'cui_str': 'valacyclovir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0242648', 'cui_str': 'Vertical infection transmission'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0002627', 'cui_str': 'Amniocentesis'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",10.0,0.675587,"Early treatment of pregnant women with primary infection might prevent termination of pregnancies or delivery of infants with congenital cytomegalovirus.
","[{'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Shahar-Nissan', 'Affiliation': 'Department of Pediatrics ""C"", Schneider Children\'s Medical Center of Israel, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: kerens411@gmail.com.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pardo', 'Affiliation': 'Helen Schneider Hospital for Women, Rabin Medical Center, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Peled', 'Affiliation': 'Department of Pediatrics ""C"", Schneider Children\'s Medical Center of Israel, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Irit', 'Initials': 'I', 'LastName': 'Krause', 'Affiliation': 'Department of Pediatrics ""C"", Schneider Children\'s Medical Center of Israel, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Efraim', 'Initials': 'E', 'LastName': 'Bilavsky', 'Affiliation': 'Department of Pediatrics ""C"", Schneider Children\'s Medical Center of Israel, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Arnon', 'Initials': 'A', 'LastName': 'Wiznitzer', 'Affiliation': 'Helen Schneider Hospital for Women, Rabin Medical Center, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Hadar', 'Affiliation': 'Helen Schneider Hospital for Women, Rabin Medical Center, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Amir', 'Affiliation': 'Helen Schneider Hospital for Women, Rabin Medical Center, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31868-7']
1655,32929721,The effect of two calcium silicate-based and one epoxy resin-based root canal sealer on postoperative pain: a randomized controlled trial.,"AIM


To compare the effect of two calcium silicate-based (Endoseal MTA and EndoSequence BC Sealer) and an epoxy resin-based (AH Plus) root canal sealer on postoperative pain following single-visit root canal treatment on molar teeth.
METHODOLOGY


Patients (n = 90) having one first or second molar tooth diagnosed with asymptomatic irreversible pulpitis were randomly divided into three groups according to the sealer used (n = 30) and were treated by two endodontists having at least 10 years of experience. All patients received a single-visit root canal treatment. After the treatments, postoperative pain scores and analgesic intake were recorded at 6, 12, 24 and 48 h, and 3, 4, 5, 6 and 7 days. The data were analysed statistically using non-parametric Kruskal-Wallis tests (for the comparisons of the age and VAS scores), Friedman tests (for the assessments of the changes in pain scores over time), chi-squared tests (for the comparisons of categorical variables) and Spearman's correlation test (for the correlation assessments of the age and gender factors with postoperative pain; α = 0.05).
RESULTS


There were no significant differences amongst the groups in terms of postoperative pain at any time-points assessed (P > 0.05) nor for analgesic intake of patients amongst the groups (P > 0.05). Analgesic intake decreased significantly after 12 h in all groups (P < 0.05).
CONCLUSIONS


The sealers tested in this study were associated with similar levels of postoperative pain and were associated with a similar intake of analgesics.",2020,"Analgesic intake decreased significantly after 12 hours in all groups (P<0.05).
",['Patients (n=90) having one first or second molar tooth diagnosed with asymptomatic irreversible pulpitis'],"['calcium silicate-based (Endoseal MTA and EndoSequence BC Sealer', 'single-visit root canal treatment', 'epoxy resin-based (AH Plus) root canal sealer', 'calcıum sılıcate-based and one epoxy resın-based root canal sealer']","['Analgesic intake', 'postoperative pain', 'analgesic intake', 'nonparametric Kruskal-Wallis tests', 'postoperative pain scores and analgesic intake']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0932486', 'cui_str': 'Structure of second molar tooth'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]","[{'cui': 'C0054483', 'cui_str': 'calcium silicate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0014631', 'cui_str': 'Epoxy resin'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.052653,"Analgesic intake decreased significantly after 12 hours in all groups (P<0.05).
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Aslan', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Dönmez Özkan', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Aydın Adnan Menderes University, Efeler, Turkey.'}]",International endodontic journal,['10.1111/iej.13411']
1656,32936795,Switch to second-line versus continued first-line antiretroviral therapy for patients with low-level HIV-1 viremia: An open-label randomized controlled trial in Lesotho.,"BACKGROUND


Current World Health Organization (WHO) antiretroviral therapy (ART) guidelines define virologic failure as two consecutive viral load (VL) measurements ≥1,000 copies/mL, triggering empiric switch to next-line ART. This trial assessed if patients with sustained low-level HIV-1 viremia on first-line ART benefit from a switch to second-line treatment.
METHODS AND FINDINGS


This multicenter, parallel-group, open-label, superiority, randomized controlled trial enrolled patients on first-line ART containing non-nucleoside reverse transcriptase inhibitors (NNRTI) with two consecutive VLs ≥100 copies/mL, with the second VL between 100-999 copies/mL, from eight clinics in Lesotho. Consenting participants were randomly assigned (1:1), stratified by facility, demographic group, and baseline VL, to either switch to second-line ART (switch group) or continued first-line ART (control group; WHO guidelines). The primary endpoint was viral suppression (<50 copies/mL) at 36 weeks. Analyses were by intention to treat, using logistic regression models, adjusted for demographic group and baseline VL. Between August 1, 2017, and August 7, 2019, 137 individuals were screened, of whom 80 were eligible and randomly assigned to switch (n = 40) or control group (n = 40). The majority of participants were female (54 [68%]) with a median age of 42 y (interquartile range [IQR] 35-51), taking tenofovir disoproxil fumarate/lamivudine/efavirenz (49 [61%]) and on ART for a median of 5.9 y (IQR 3.3-8.6). At 36 weeks, 22/40 (55%) participants in the switch versus 10/40 (25%) in the control group achieved viral suppression (adjusted difference 29%, 95% CI 8%-50%, p = 0.009). The switch group had significantly higher probability of viral suppression across different VL thresholds (<20, <100, <200, <400, and <600 copies/mL) but not for <1,000 copies/mL. Thirty-four (85%) participants in switch group and 21 (53%) in control group experienced at least one adverse event (AE) (p = 0.002). No hospitalization or death or other serious adverse events were observed. Study limitations include a follow-up period too short to observe differences in clinical outcomes, missing values in CD4 cell counts due to national stockout of reagents during the study, and limited generalizability of findings to other than NNRTI-based first-line ART regimens.
CONCLUSIONS


In this study, switching to second-line ART among patients with sustained low-level HIV-1 viremia resulted in a higher proportion of participants with viral suppression. These results endorse lowering the threshold for virologic failure in future WHO guidelines.
TRIAL REGISTRATION


The trial is registered at ClinicalTrials.gov, NCT03088241.",2020,No hospitalization or death or other serious adverse events were observed.,"['enrolled patients on first-line ART containing non-nucleoside reverse transcriptase inhibitors (NNRTI) with two consecutive VLs ≥100 copies/mL, with the second VL between 100-999 copies/mL, from eight clinics in Lesotho', 'Consenting participants', 'patients with sustained low-level HIV-1 viremia on first-line ART benefit from a switch to second-line treatment', '49 [61%]) and on ART for a median of 5.9 y (IQR 3.3-8.6', 'patients with low-level HIV-1 viremia', 'Between August 1, 2017, and August 7, 2019, 137 individuals were screened, of whom 80 were eligible and randomly assigned to switch (n = 40) or control group (n = 40', 'participants were female (54 [68%]) with a median age of 42 y (interquartile range [IQR] 35-51), taking']","['tenofovir disoproxil fumarate/lamivudine/efavirenz', 'switch to second-line ART (switch group) or continued first-line ART', 'Current World Health Organization (WHO) antiretroviral therapy']","['hospitalization or death or other serious adverse events', 'viral suppression', 'probability of viral suppression', 'virologic failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3541376', 'cui_str': 'Non-nucleoside reverse transcriptase inhibitors'}, {'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0282519', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C5191069', 'cui_str': '999'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0023376', 'cui_str': 'Lesotho'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C1710038', 'cui_str': 'Second line treatment'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1699206', 'cui_str': 'Virologic failure'}]",137.0,0.276927,No hospitalization or death or other serious adverse events were observed.,"[{'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Amstutz', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Bienvenu Lengo', 'Initials': 'BL', 'LastName': 'Nsakala', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Vanobberghen', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Muhairwe', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Tracy Renée', 'Initials': 'TR', 'LastName': 'Glass', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Namane', 'Affiliation': 'Motebang Government Hospital, Leribe, Lesotho.'}, {'ForeName': 'Tlali', 'Initials': 'T', 'LastName': 'Mpholo', 'Affiliation': 'Senkatana HIV Clinic, Maseru, Lesotho.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Battegay', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Klimkait', 'Affiliation': 'Molecular Virology, Department of Biomedicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Niklaus Daniel', 'Initials': 'ND', 'LastName': 'Labhardt', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}]",PLoS medicine,['10.1371/journal.pmed.1003325']
1657,32865375,Early Rhythm-Control Therapy in Patients with Atrial Fibrillation.,"BACKGROUND


Despite improvements in the management of atrial fibrillation, patients with this condition remain at increased risk for cardiovascular complications. It is unclear whether early rhythm-control therapy can reduce this risk.
METHODS


In this international, investigator-initiated, parallel-group, open, blinded-outcome-assessment trial, we randomly assigned patients who had early atrial fibrillation (diagnosed ≤1 year before enrollment) and cardiovascular conditions to receive either early rhythm control or usual care. Early rhythm control included treatment with antiarrhythmic drugs or atrial fibrillation ablation after randomization. Usual care limited rhythm control to the management of atrial fibrillation-related symptoms. The first primary outcome was a composite of death from cardiovascular causes, stroke, or hospitalization with worsening of heart failure or acute coronary syndrome; the second primary outcome was the number of nights spent in the hospital per year. The primary safety outcome was a composite of death, stroke, or serious adverse events related to rhythm-control therapy. Secondary outcomes, including symptoms and left ventricular function, were also evaluated.
RESULTS


In 135 centers, 2789 patients with early atrial fibrillation (median time since diagnosis, 36 days) underwent randomization. The trial was stopped for efficacy at the third interim analysis after a median of 5.1 years of follow-up per patient. A first-primary-outcome event occurred in 249 of the patients assigned to early rhythm control (3.9 per 100 person-years) and in 316 patients assigned to usual care (5.0 per 100 person-years) (hazard ratio, 0.79; 96% confidence interval, 0.66 to 0.94; P = 0.005). The mean (±SD) number of nights spent in the hospital did not differ significantly between the groups (5.8±21.9 and 5.1±15.5 days per year, respectively; P = 0.23). The percentage of patients with a primary safety outcome event did not differ significantly between the groups; serious adverse events related to rhythm-control therapy occurred in 4.9% of the patients assigned to early rhythm control and 1.4% of the patients assigned to usual care. Symptoms and left ventricular function at 2 years did not differ significantly between the groups.
CONCLUSIONS


Early rhythm-control therapy was associated with a lower risk of adverse cardiovascular outcomes than usual care among patients with early atrial fibrillation and cardiovascular conditions. (Funded by the German Ministry of Education and Research and others; EAST-AFNET 4 ISRCTN number, ISRCTN04708680; ClinicalTrials.gov number, NCT01288352; EudraCT number, 2010-021258-20.).",2020,The percentage of patients with a primary safety outcome event did not differ significantly between the groups; serious adverse events related to rhythm-control therapy occurred in 4.9% of the patients assigned to early rhythm control and 1.4% of the patients assigned to usual care.,"['patients who had early atrial fibrillation (diagnosed ≤1 year before enrollment) and cardiovascular conditions to receive either', 'patients with early atrial fibrillation and cardiovascular conditions', 'Patients with Atrial Fibrillation', 'In 135 centers, 2789 patients with early atrial fibrillation (median time since diagnosis, 36 days) underwent randomization']","['early rhythm control or usual care', 'antiarrhythmic drugs or atrial fibrillation ablation']","['number of nights spent in the hospital per year', 'composite of death from cardiovascular causes, stroke, or hospitalization with worsening of heart failure or acute coronary syndrome', 'serious adverse events related to rhythm-control therapy', 'symptoms and left ventricular function', 'Symptoms and left ventricular function', 'mean (±SD) number of nights spent in the hospital', 'early rhythm control', 'composite of death, stroke, or serious adverse events related to rhythm-control therapy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",2789.0,0.143464,The percentage of patients with a primary safety outcome event did not differ significantly between the groups; serious adverse events related to rhythm-control therapy occurred in 4.9% of the patients assigned to early rhythm control and 1.4% of the patients assigned to usual care.,"[{'ForeName': 'Paulus', 'Initials': 'P', 'LastName': 'Kirchhof', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Camm', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goette', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Brandes', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Eckardt', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Elvan', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fetsch', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'van Gelder', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Haase', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Laurent M', 'Initials': 'LM', 'LastName': 'Haegeli', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hamann', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Heidbüchel', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hindricks', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Kautzner', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Kuck', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Lluis', 'Initials': 'L', 'LastName': 'Mont', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'G Andre', 'Initials': 'GA', 'LastName': 'Ng', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Rekosz', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Schoen', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schotten', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Suling', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Taggeselle', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Sakis', 'Initials': 'S', 'LastName': 'Themistoclakis', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Eik', 'Initials': 'E', 'LastName': 'Vettorazzi', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Panos', 'Initials': 'P', 'LastName': 'Vardas', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Willems', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Harry J G M', 'Initials': 'HJGM', 'LastName': 'Crijns', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Günter', 'Initials': 'G', 'LastName': 'Breithardt', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2019422']
1658,32865376,Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation.,"BACKGROUND


The effect of single as compared with dual antiplatelet treatment on bleeding and thromboembolic events after transcatheter aortic-valve implantation (TAVI) in patients who do not have an indication for long-term anticoagulation has not been well studied.
METHODS


In a randomized, controlled trial, we assigned a subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive aspirin alone or aspirin plus clopidogrel for 3 months. The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding over a period of 12 months. Most bleeding at the TAVI puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2) at 1 year, with both outcomes tested sequentially for noninferiority (noninferiority margin, 7.5 percentage points) and superiority.
RESULTS


A total of 331 patients were assigned to receive aspirin alone and 334 were assigned to receive aspirin plus clopidogrel. A bleeding event occurred in 50 patients (15.1%) receiving aspirin alone and in 89 (26.6%) receiving aspirin plus clopidogrel (risk ratio, 0.57; 95% confidence interval [CI], 0.42 to 0.77; P = 0.001). Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P = 0.005). A secondary composite 1 event occurred in 76 patients (23.0%) receiving aspirin alone and in 104 (31.1%) receiving aspirin plus clopidogrel (difference, -8.2 percentage points; 95% CI for noninferiority, -14.9 to -1.5; P<0.001; risk ratio, 0.74; 95% CI for superiority, 0.57 to 0.95; P = 0.04). A secondary composite 2 event occurred in 32 patients (9.7%) and 33 patients (9.9%), respectively (difference, -0.2 percentage points; 95% CI for noninferiority, -4.7 to 4.3; P = 0.004; risk ratio, 0.98; 95% CI for superiority, 0.62 to 1.55; P = 0.93). A total of 44 patients (13.3%) and 32 (9.6%), respectively, received oral anticoagulation during the trial.
CONCLUSIONS


Among patients undergoing TAVI who did not have an indication for oral anticoagulation, the incidence of bleeding and the composite of bleeding or thromboembolic events at 1 year were significantly less frequent with aspirin than with aspirin plus clopidogrel administered for 3 months. (Funded by the Netherlands Organization for Health Research and Development; POPular TAVI EU Clinical Trials Register number, 2013-003125-28; ClinicalTrials.gov number, NCT02247128.).",2020,"Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P = 0.005).","['for 3 months', '331 patients', 'patients who do not have an indication for long-term anticoagulation', '44 patients (13.3%) and 32 (9.6%), respectively, received oral anticoagulation during the trial', 'subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive', 'after Transcatheter Aortic-Valve Implantation']","['aspirin alone or aspirin plus clopidogrel', 'aspirin plus clopidogrel', 'aspirin alone', 'Aspirin with or without Clopidogrel', 'aspirin', 'transcatheter aortic-valve implantation (TAVI']","['incidence of bleeding and the composite of bleeding or thromboembolic events', 'all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding', 'bleeding and thromboembolic events', 'composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2', 'bleeding event', 'bleeding']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",331.0,0.493064,"Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P = 0.005).","[{'ForeName': 'Jorn', 'Initials': 'J', 'LastName': 'Brouwer', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Nijenhuis', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Delewi', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Renicus S', 'Initials': 'RS', 'LastName': 'Hermanides', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Holvoet', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Christophe L F', 'Initials': 'CLF', 'LastName': 'Dubois', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Frambach', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'De Bruyne', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Gert K', 'Initials': 'GK', 'LastName': 'van Houwelingen', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Jan A S', 'Initials': 'JAS', 'LastName': 'Van Der Heyden', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Toušek', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van der Kley', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Buysschaert', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Carl E', 'Initials': 'CE', 'LastName': 'Schotborgh', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Ferdinande', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'van der Harst', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Roosen', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Peper', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Frederick W F', 'Initials': 'FWF', 'LastName': 'Thielen', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Veenstra', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Dean R P P', 'Initials': 'DRPP', 'LastName': 'Chan Pin Yin', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Swaans', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Benno J W M', 'Initials': 'BJWM', 'LastName': 'Rensing', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Arnoud W J', 'Initials': 'AWJ', 'LastName': ""van 't Hof"", 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Timmers', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Kelder', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Pieter R', 'Initials': 'PR', 'LastName': 'Stella', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Baan', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}]",The New England journal of medicine,['10.1056/NEJMoa2017815']
1659,32942627,Evaluation of Food-Intake Behavior in a Healthy Population: Personalized vs. One-Size-Fits-All.,"In public health initiatives, generic nutrition advice (GNA) from national guidelines has a limited effect on food-intake improvement. Personalized nutrition advice (PNA) may enable dietary behavior change. A monocentric, randomized, parallel, controlled clinical trial was performed in males ( n  = 55) and females ( n  = 100) aged 25 to 70 years. Participants were allocated to control, GNA or PNA groups. The PNA group consisted of automatically generated dietary advice based on personal metabolic health parameters, dietary intake, anthropometric and hemodynamic measures, gender and age. Participants who received PNA ( n  = 51) improved their nutritional intake status for fruits  P  ( p  < 0.0001), whole grains ( p  = 0.008), unsalted nuts ( p  < 0.0001), fish ( p  = 0.0003), sugar-sweetened beverages ( p  = 0.005), added salt ( p  = 0.003) and less unhealthy choices ( p  = 0.002), whereas no improvements were observed in the control and GNA group. PNA participants were encouraged to set a goal for one or multiple food categories. Goal-setting led to greater improvement of food categories within the PNA group including; unsalted nuts ( p  < 0.0001), fruits ( p  = 0.0001), whole grains ( p  = 0.005), fish ( p  = 0.0001), dairy ( p  = 0.007), vegetables ( p  = 0.01) and unhealthy choices ( p  = 0.02). In a healthy population, participants receiving PNA changed their food-intake behavior more favorably than participants receiving GNA or no advice. When personal goals were set, nutritional behavior was more prone to change.",2020,"Participants who received PNA ( n  = 51) improved their nutritional intake status for fruits  P  ( p  < 0.0001), whole grains ( p  = 0.008), unsalted nuts ( p  < 0.0001), fish ( p  =","['a Healthy Population', 'males ( n  = 55) and females ( n  = 100) aged 25 to 70 years']","['PNA', 'control, GNA or PNA', 'Personalized nutrition advice (PNA', 'GNA']","['sugar-sweetened beverages', 'nutritional intake status']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}]","[{'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",100.0,0.0403269,"Participants who received PNA ( n  = 51) improved their nutritional intake status for fruits  P  ( p  < 0.0001), whole grains ( p  = 0.008), unsalted nuts ( p  < 0.0001), fish ( p  =","[{'ForeName': 'Femke P M', 'Initials': 'FPM', 'LastName': 'Hoevenaars', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Research Group Microbiology & Systems Biology, P.O. Box 360, 3700 AJ Zeist, The Netherlands.'}, {'ForeName': 'Charlotte M M', 'Initials': 'CMM', 'LastName': 'Berendsen', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Research Group Microbiology & Systems Biology, P.O. Box 360, 3700 AJ Zeist, The Netherlands.'}, {'ForeName': 'Wilrike J', 'Initials': 'WJ', 'LastName': 'Pasman', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Research Group Microbiology & Systems Biology, P.O. Box 360, 3700 AJ Zeist, The Netherlands.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'van den Broek', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Research Group Microbiology & Systems Biology, P.O. Box 360, 3700 AJ Zeist, The Netherlands.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Barrat', 'Affiliation': 'Laboratoire Lescuyer, Department of Research, 15 rue le Corbusier, CEDEX, F-17442 Aytré, France.'}, {'ForeName': 'Iris M', 'Initials': 'IM', 'LastName': 'de Hoogh', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Research Group Microbiology & Systems Biology, P.O. Box 360, 3700 AJ Zeist, The Netherlands.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Wopereis', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Research Group Microbiology & Systems Biology, P.O. Box 360, 3700 AJ Zeist, The Netherlands.'}]",Nutrients,['10.3390/nu12092819']
1660,32944790,Acute effects of alcohol on error-elicited negative affect during a cognitive control task.,"RATIONALE


Alcohol intoxication can dampen negative affective reactions to stressors. Recently, it has been proposed that these acute anxiolytic effects of alcohol may extend to dampening of negative affective reactions to error commission during cognitive control tasks. Nonetheless, empirical verification of this claim is lacking.
OBJECTIVES


Test the acute effect of alcohol on negative affective reactions to errors during an effort-demanding cognitive control task.
METHODS


Healthy, young adult social drinkers (N = 96 [49 women], 21-36 years old) were randomly assigned to consume alcohol (0.80 g/kg; n = 33 [15 female]), active placebo (0.04 g/kg; n = 33 [18 women]), or a non-alcoholic control beverage (n = 30 [16 women]) before completing the Eriksen flanker task. Corrugator supercilii (Corr) activation, a psychophysiological index of negative affect, was tracked across the task. Two neurophysiological reactions to errors, the error-related negativity (ERN) and the error positivity (Pe), were also measured.
RESULTS


Erroneous actions increased Corr activation in the control and (to a lesser extent) placebo groups, but not in the alcohol group. Error-induced Corr activation was coupled to ERN and Pe in the control, but not in the alcohol and placebo groups. Error-induced Corr activation was not coupled to post-error performance adjustments in any group.
CONCLUSIONS


The ability of alcohol to dampen error-related negative affect was verified. It was also shown that placebo alone can disrupt coupling of affective and (neuro)cognitive reactions to errors. Although its behavioral relevance remains to be demonstrated, more attention should be paid to the role of affect in action monitoring and cognitive control processes.",2020,"Error-induced Corr activation was coupled to ERN and Pe in the control, but not in the alcohol and placebo groups.","['Healthy, young adult social drinkers (N\u2009=\u200996 [49 women], 21-36\xa0years old']","['consume alcohol', 'alcohol', 'placebo', 'active placebo', 'non-alcoholic control beverage (n\u2009=\u200930 [16 women]) before completing the Eriksen flanker task']","['Corrugator supercilii (Corr) activation', 'error-related negativity (ERN) and the error positivity (Pe', 'Corr activation']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337676', 'cui_str': 'Social drinker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0224127', 'cui_str': 'Structure of corrugator supercilii muscle'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0266923,"Error-induced Corr activation was coupled to ERN and Pe in the control, but not in the alcohol and placebo groups.","[{'ForeName': 'Roberto U', 'Initials': 'RU', 'LastName': 'Cofresí', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO, 65211, USA. cofresir@missouri.edu.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Bartholow', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO, 65211, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05619-4']
1661,32945261,A Mobile Social Network-Based Smoking Cessation Intervention for Chinese Male Smokers: Protocol for a Pilot Randomized Controlled Trial.,"BACKGROUND


Approximately 2 million Chinese people die annually from tobacco-related diseases, mostly men; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation advice or support. A social network-based gamified smoking cessation intervention (SCAMPI: Smoking Cessation App for Chinese Male: Pilot Intervention) is designed to help Chinese male smokers to quit smoking.
OBJECTIVE


This paper aims to present the protocol of a study examining the preliminary effectiveness of SCAMPI by comparing the prolonged abstinence rate of a group of users with a comparator group during a 6-week follow-up period.
METHODS


A two-arm pilot randomized controlled trial was conducted to assess the preliminary effectiveness and acceptability of the SCAMPI program as a smoking cessation intervention. After initial web-based screening, the first 80 eligible individuals who had gone through the required registration process were registered as participants of the trial. Participants were randomly allocated to the intervention group (n=40) and the control group (n=40). Participants in the intervention group used the full version of the SCAMPI program, which is a Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users. The program delivers a range of smoking cessation approaches, including helping users to make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, providing information about smoking harms, motivational messages to help users overcome urges, providing standardized tests to users for assessing their levels of nicotine dependence and lung health, and providing a platform to encourage social support between users. Participants in the control group used the restricted version of the SCAMPI program (placebo app).
RESULTS


Recruitment for this project commenced in January 2019 and proceeded until March 2019. Follow-up data collection was commenced and completed by June 2019. The primary outcome measure of the study was the 30-day bio-verified smoking abstinence at the 6-week follow-up (self-reported data verified by the Nicotine Cotinine Saliva Test). The secondary outcome measures of the study included participants' cigarette consumption reduction (compared baseline daily cigarette consumption with end-of-trial daily cigarette consumption), participants' 7-day smoking abstinence at 4-week and 6-week follow-up (self-reported), participants' 30-day smoking abstinence at 6-week follow-up (self-reported data only), and participants' acceptability and satisfaction levels of using the SCAMPI program (measured by the Mobile App Rating Scale questionnaire).
CONCLUSIONS


If the SCAMPI program is shown to be preliminary effective, the study will be rolled out to be a future trial with a larger sample size and longer follow-up (6 months) to identify if it is an effective social network-based tool to support Chinese male smokers to quit smoking.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12618001089224; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375381.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR1-10.2196/18071.",2020,"Participants in the intervention group used the full version of the SCAMPI program, which is a Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users.","['Chinese Male', '80 eligible individuals who had gone through the required registration process were registered as participants of the trial', 'Chinese male smokers to quit smoking', 'Chinese Male Smokers', 'Approximately 2 million Chinese people die annually from tobacco-related diseases, mostly men']","['Mobile Social Network-Based Smoking Cessation Intervention', 'SCAMPI program', 'social network-based gamified smoking cessation intervention (SCAMPI: Smoking Cessation App', 'Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users', 'SCAMPI program (placebo app', 'SCAMPI']","[""participants' cigarette consumption reduction (compared baseline daily cigarette consumption with end-of-trial daily cigarette consumption), participants' 7-day smoking abstinence"", '30-day smoking abstinence', '30-day bio-verified smoking abstinence at the 6-week follow-up (self-reported data verified by the Nicotine Cotinine Saliva Test', ""participants' acceptability and satisfaction levels of using the SCAMPI program (measured by the Mobile App Rating Scale questionnaire""]","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453056', 'cui_str': 'Scampi'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0453056', 'cui_str': 'Scampi'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0757957,"Participants in the intervention group used the full version of the SCAMPI program, which is a Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users.","[{'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'The National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Elsie', 'Initials': 'E', 'LastName': 'Ho', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'The National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Whittaker', 'Affiliation': 'The National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Tingzhong', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Centre for Tobacco Control Research, School of Medicine, The Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'The National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand.'}]",JMIR research protocols,['10.2196/18071']
1662,32945777,Promoting Health and Well-Being Through Mobile Health Technology (Roadmap 2.0) in Family Caregivers and Patients Undergoing Hematopoietic Stem Cell Transplantation: Protocol for the Development of a Mobile Randomized Controlled Trial.,"BACKGROUND


Cancer patients who undergo allogeneic hematopoietic stem cell transplantation are among the most medically fragile patient populations with extreme demands for caregivers. Indeed, with earlier hospital discharges, the demands placed on caregivers continue to intensify. Moreover, an increased number of allogeneic hematopoietic stem cell transplantations are being performed worldwide, and this expensive procedure has significant economic consequences. Thus, the health and well-being of family caregivers have attracted widespread attention. Mobile health technology has been shown to deliver flexible, and time- and cost-sparing interventions to support family caregivers across the care trajectory.
OBJECTIVE


This protocol aims to leverage technology to deliver a novel caregiver-facing mobile health intervention named Roadmap 2.0. We will evaluate the effectiveness of Roadmap 2.0 in family caregivers of patients undergoing hematopoietic stem cell transplantation.
METHODS


The Roadmap 2.0 intervention will consist of a mobile randomized trial comparing a positive psychology intervention arm with a control arm in family caregiver-patient dyads. The primary outcome will be caregiver health-related quality of life, as assessed by the PROMIS Global Health scale at day 120 post-transplant. Secondary outcomes will include other PROMIS caregiver- and patient-reported outcomes, including companionship, self-efficacy for managing symptoms, self-efficacy for managing daily activities, positive affect and well-being, sleep disturbance, depression, and anxiety. Semistructured qualitative interviews will be conducted among participants at the completion of the study. We will also measure objective physiological markers (eg, sleep, activity, heart rate) through wearable wrist sensors and health care utilization data through electronic health records.
RESULTS


We plan to enroll 166 family caregiver-patient dyads for the full data analysis. The study has received Institutional Review Board approval as well as Code Review and Information Assurance approval from our health information technology services. Owing to the COVID-19 pandemic, the study has been briefly put on hold. However, recruitment began in August 2020. We have converted all recruitment, enrollment, and onboarding processes to be conducted remotely through video telehealth. Consent will be obtained electronically through the Roadmap 2.0 app.
CONCLUSIONS


This mobile randomized trial will determine if positive psychology-based activities delivered through mobile health technology can improve caregiver health-related quality of life over a 16-week study period. This study will provide additional data on the effects of wearable wrist sensors on caregiver and patient self-report outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04094844; https://www.clinicaltrials.gov/ct2/show/NCT04094844.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/19288.",2020,"Mobile health technology has been shown to deliver flexible, and time- and cost-sparing interventions to support family caregivers across the care trajectory.
","['Family Caregivers and Patients Undergoing Hematopoietic Stem Cell Transplantation', 'Cancer patients who undergo allogeneic hematopoietic stem cell transplantation', '166 family caregiver-patient dyads for the full data analysis', 'family caregivers of patients undergoing hematopoietic stem cell transplantation']",['positive psychology intervention arm with a control arm in family caregiver-patient dyads'],"['objective physiological markers (eg, sleep, activity, heart rate', 'caregiver health-related quality of life', 'caregiver health-related quality of life, as assessed by the PROMIS Global Health scale', 'PROMIS caregiver- and patient-reported outcomes, including companionship, self-efficacy for managing symptoms, self-efficacy for managing daily activities, positive affect and well-being, sleep disturbance, depression, and anxiety']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.40449,"Mobile health technology has been shown to deliver flexible, and time- and cost-sparing interventions to support family caregivers across the care trajectory.
","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Rozwadowski', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Manasa', 'Initials': 'M', 'LastName': 'Dittakavi', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Mazzoli', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Afton L', 'Initials': 'AL', 'LastName': 'Hassett', 'Affiliation': 'Department of Anesthesia, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Braun', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Barton', 'Affiliation': 'School of Nursing, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Noelle', 'Initials': 'N', 'LastName': 'Carlozzi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Srijan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Department of Psychiatry, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Muneesh', 'Initials': 'M', 'LastName': 'Tewari', 'Affiliation': 'Department of Internal Medicine, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hanauer', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Sung Won', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}]",JMIR research protocols,['10.2196/19288']
1663,32903262,Mediterranean diet and endothelial function in patients with coronary heart disease: An analysis of the CORDIOPREV randomized controlled trial.,"BACKGROUND


Endothelial dysfunction is a crucial step in atherosclerosis development, and its severity is determinant for the risk of cardiovascular recurrence. Diet may be an effective strategy to protect the endothelium, although there is no consensus about the best dietary model. The CORonary Diet Intervention with Olive oil and cardiovascular PREVention (CORDIOPREV) study is an ongoing prospective, randomized, single-blind, controlled trial in 1,002 coronary heart disease (CHD) patients, whose primary objective is to compare the effect of 2 healthy dietary patterns (low-fat versus Mediterranean diet) on the incidence of cardiovascular events. Here, we report the results of one secondary outcome of the CORDIOPREV study: to evaluate the effect of these diets on endothelial function, assessed by flow-mediated dilation (FMD) of the brachial artery.
METHODS AND FINDINGS


From the total participants taking part in the CORDIOPREV study, 805 completed endothelial function study at baseline and were randomized to follow a Mediterranean diet (35% fat, 22% monounsaturated fatty acids [MUFAs], and <50% carbohydrates) or a low-fat diet (28% fat, 12% MUFAs, and >55% carbohydrates), with endothelial function measurement repeated after 1 year. As secondary objectives and to explore different underlying mechanisms in the modulation of endothelial function, we quantified endothelial microparticles (EMPs) and endothelial progenitor cells (EPCs) and evaluated, in 24 preselected patients, in vitro cellular processes related to endothelial damage (reactive oxygen species, apoptosis, and senescence) and endothelial repair (cell proliferation and angiogenesis), as well as other modulators (micro-RNAs [miRNAs] and proteins). Patients who followed the Mediterranean diet had higher FMD (3.83%; 95% confidence interval [CI]: 2.91-4.23) compared with those in the low-fat diet (1.16%; 95% CI: 0.80 to 1.98) with a difference between diets of 2.63% (95% CI: 1.89-3.40, p = 0.011), even in those patients with severe endothelial dysfunction. We observed higher EPC levels (group difference: 1.64%; 95% CI: 0.79-2.13, p = 0.028) and lower EMPs (group difference: -755 EMPs/μl; 95% CI: -1,010 to -567, p = 0.015) after the Mediterranean diet compared with the low-fat diet in all patients. We also observed lower intracellular reactive oxygen species (ROS) production (group difference: 11.1; 95% CI: 2.5 to 19.6, p = 0.010), cellular apoptosis (group difference: -20.2; 95% CI: -26.7 to -5.11, p = 0.013) and senescence (18.0; 95% CI: 3.57 to 25.1, p = 0.031), and higher cellular proliferation (group difference: 11.3; 95% CI: 4.51 to 13.5, p = 0.011) and angiogenesis (total master segments length, group difference: 549; 95% CI: 110 to 670, p = 0.022) after the Mediterranean diet than the low-fat diet. Each dietary intervention was associated with distinct changes in the epigenetic and proteomic factors that modulate biological process associated with endothelial dysfunction. The evaluation of endothelial function is a substudy of the CORDIOPREV study. As in any substudy, these results should be treated with caution, such as the potential for false positives because of the exploratory nature of the analyses.
CONCLUSIONS


Our results suggest that the Mediterranean diet better modulates endothelial function compared with a low-fat diet and is associated with a better balance of vascular homeostasis in CHD patients, even in those with severe endothelial dysfunction.
CLINICAL TRIAL REGISTRATION


URL, http://www.cordioprev.es/index.php/en. clinicaltrials.gov number NCT00924937.",2020,"We also observed lower intracellular reactive oxygen species (ROS) production (group difference: 11.1; 95% CI: 2.5 to 19.6, p = 0.010), cellular apoptosis (group difference: -20.2; 95% CI: -26.7 to -5.11, p = 0.013) and senescence (18.0; 95% CI: 3.57 to 25.1, p = 0.031), and higher cellular proliferation (group difference: 11.3; 95% CI: 4.51 to 13.5, p = 0.011) and angiogenesis (total master segments length, group difference: 549; 95% CI: 110 to 670, p = 0.022) after the Mediterranean diet than the low-fat diet.","['From the total participants taking part in the CORDIOPREV study, 805 completed endothelial function study at baseline', '1,002 coronary heart disease (CHD) patients', '24 preselected patients', 'patients with coronary heart disease']","['Mediterranean diet and endothelial function', 'healthy dietary patterns (low-fat versus Mediterranean diet', 'CORonary Diet Intervention with Olive oil and cardiovascular PREVention', 'Mediterranean diet (35% fat, 22% monounsaturated fatty acids [MUFAs], and <50% carbohydrates) or a low-fat diet (28% fat, 12% MUFAs, and >55% carbohydrates', 'Mediterranean diet']","['cellular apoptosis', 'endothelial microparticles (EMPs) and endothelial progenitor cells (EPCs', 'vascular homeostasis', 'endothelial function, assessed by flow-mediated dilation (FMD) of the brachial artery', 'EPC levels', 'senescence', 'endothelial damage (reactive oxygen species, apoptosis, and senescence) and endothelial repair (cell proliferation and angiogenesis', 'endothelial function', 'higher cellular proliferation', 'intracellular reactive oxygen species (ROS) production', 'higher FMD']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015687', 'cui_str': 'Monounsaturated fatty acid'}]","[{'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C2350307', 'cui_str': 'Microparticles, Cell-Derived'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0169014', 'cui_str': 'erucylphosphocholine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0596290', 'cui_str': 'Cellular Proliferation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}]",1002.0,0.154778,"We also observed lower intracellular reactive oxygen species (ROS) production (group difference: 11.1; 95% CI: 2.5 to 19.6, p = 0.010), cellular apoptosis (group difference: -20.2; 95% CI: -26.7 to -5.11, p = 0.013) and senescence (18.0; 95% CI: 3.57 to 25.1, p = 0.031), and higher cellular proliferation (group difference: 11.3; 95% CI: 4.51 to 13.5, p = 0.011) and angiogenesis (total master segments length, group difference: 549; 95% CI: 110 to 670, p = 0.022) after the Mediterranean diet than the low-fat diet.","[{'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Yubero-Serrano', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Fernandez-Gandara', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Garcia-Rios', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Oriol A', 'Initials': 'OA', 'LastName': 'Rangel-Zuñiga', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Gutierrez-Mariscal', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Jose D', 'Initials': 'JD', 'LastName': 'Torres-Peña', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Marin', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez-Moreno', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Justo P', 'Initials': 'JP', 'LastName': 'Castaño', 'Affiliation': 'CIBER Physiopathology of Obesity and Nutrition (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Delgado-Lista', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Ordovas', 'Affiliation': 'Jean Mayer US Department of Agriculture Human Nutrition Research Center on Aging, Tufts University School of Medicine, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Perez-Martinez', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lopez-Miranda', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}]",PLoS medicine,['10.1371/journal.pmed.1003282']
1664,32915800,Public stigma towards prolonged grief disorder: Does diagnostic labeling matter?,"The recent introduction of prolonged grief disorder (PGD) as a diagnostic category may cause negative social reactions (i.e. public stigma). Vignette experiments demonstrate that persons with both PGD symptoms and a PGD diagnosis elicit more public stigma than persons who experience integrated grief. However, the strength of the influence of the diagnosis itself remains unclear: We aimed to clarify if the diagnostic label PGD produces additional public stigma beyond PGD symptoms. We further compared whether public stigma varies between the label PGD and the label major depressive episode (MDE) (when PGD symptoms are present) and if gender of the bereaved person influences public stigma or moderates the aforementioned effects. Eight-hundred fifty-two participants (77% female; Mage = 32.6 years, SD = 13.3) were randomly assigned to read online one of eight vignettes describing either a bereaved male or female, with PGD symptoms and PGD diagnosis; PGD symptoms and MDE diagnosis; PGD symptoms and no diagnosis, or no PGD symptoms and no diagnosis (i.e., integrated grief). Following the vignettes, participants indicated which negative characteristics they ascribed to the person, their emotional reactions, and preferred social distance from the person. People with PGD symptoms and PGD (or MDE) diagnosis were attributed more negative characteristics, and elicited more negative emotions and a stronger desire for social distance than people with integrated grief. However, public stigma did not differ for people with both PGD symptoms and diagnosis compared to people only experiencing PGD symptoms. Gender of the bereaved only had an influence on desired social distance, which was larger towards men. Helping severely distressed bereaved people (regardless of diagnostic status) cope with negative social reactions may help them adapt to bereavement. Results demonstrate that the experience of severe grief reactions, yet not a diagnostic label per se, causes public stigma.",2020,"However, public stigma did not differ for people with both PGD symptoms and diagnosis compared to people only experiencing PGD symptoms.","['Public stigma towards prolonged grief disorder', 'persons with both PGD symptoms', 'People with PGD symptoms and PGD (or MDE) diagnosis', 'Eight-hundred fifty-two participants (77% female; Mage = 32.6 years, SD = 13.3) were randomly assigned to read online one of eight vignettes describing either a bereaved male or female, with PGD symptoms and PGD diagnosis; PGD symptoms and MDE diagnosis; PGD symptoms and no diagnosis, or no PGD symptoms and no diagnosis (i.e., integrated grief']",[],"['public stigma', 'severe grief reactions']","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C4511668', 'cui_str': 'Prolonged grief disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0560182', 'cui_str': 'Diagnosis not made'}]",[],"[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}]",852.0,0.0295721,"However, public stigma did not differ for people with both PGD symptoms and diagnosis compared to people only experiencing PGD symptoms.","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Gonschor', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Maarten C', 'Initials': 'MC', 'LastName': 'Eisma', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Barke', 'Affiliation': 'Clinical and Biological Psychology, Department of Psychology, Catholic University Eichstaett-Ingolstadt, Eichstaett, Germany.'}, {'ForeName': 'Bettina K', 'Initials': 'BK', 'LastName': 'Doering', 'Affiliation': 'Clinical and Biological Psychology, Department of Psychology, Catholic University Eichstaett-Ingolstadt, Eichstaett, Germany.'}]",PloS one,['10.1371/journal.pone.0237021']
1665,32919098,Evaluation of a personally-tailored opioid overdose prevention education and naloxone distribution intervention to promote harm reduction and treatment readiness in individuals actively using illicit opioids.,"BACKGROUND


Opioid overdose prevention education and naloxone distribution (OEND) programs include information on general risk factors, overdose recognition, and naloxone utilization. This study evaluated a personally-tailored OEND (PTOEND) intervention designed to promote harm reduction and treatment readiness for illicit opioid users by also including education about personal overdose-risk factors and medication for opioid use disorder (MOUD).
METHOD


A secondary analysis of a randomized controlled trial testing a Peer recovery support service (PRSS) intervention, relative to Control, in adult illicit opioid users reporting treatment for an overdose in the prior 6 months. PTOEND, a 30-minute computer-guided intervention, was administered by a research assistant at the randomization visit to all participants (N = 80). Participants completed a telephone visit 3 weeks post-randomization (n = 74) to assess changes in opioid overdose/MOUD knowledge and treatment readiness. Participants completed in-person visits at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization to assess illicit opioid use and naloxone utilization (all time points) and overdose-risk behaviors (12 months). We conducted pre-post analyses of the impact of PTOEND controlling for the PRSS effect.
RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05). Self-reported opioid use was significantly decreased at each follow-up (all p < 0.01). Self-reported overdose-risk behaviors decreased significantly (6.2 to 2.4, p < 0.01). A majority of participants (65 %) reported naloxone utilization.
CONCLUSIONS


PTOEND may be effective for promoting harm reduction and treatment readiness.",2020,"RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05).","['adult illicit opioid users reporting treatment for an overdose in the prior 6 months', 'individuals actively using illicit opioids']","['naloxone distribution intervention', 'Peer recovery support service (PRSS) intervention']","['Self-reported overdose-risk behaviors', 'Self-reported opioid use', 'knowledge of overdose', 'illicit opioid use and naloxone utilization (all time points) and overdose-risk behaviors', 'desire to quit all substances', 'MOUD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]",80.0,0.027065,"RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05).","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine 231, Albert Sabin Way, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108265']
1666,32919196,Understanding the composite dimensions of the EQ-5D: An experimental approach.,"The EQ-5D(-5L) includes two composite dimensions: ""Pain or Discomfort"" (P/D) and ""Anxiety or Depression"" (A/D), which involves an inherent ambiguity. Little is known about how these composite dimensions are interpreted across contexts where (i) individuals self-report their own health; and (ii) individuals value stylised health states. We detail the nature of the ambiguity and present experimental evidence from two large online surveys (n = 1007 and n = 1415). In one survey, individuals reported both their current health and their health at the time they felt the worst because of their health. In the other, they valued stylised EQ-5D states using Discrete Choice Experiments with duration as an attribute. In both surveys, participants were randomised into treatments in which the presentation of one of the composite dimensions was altered, or a control. Our results suggest (1) In self-report, use of the composite dimensions differs across the dimensions, with P/D used mainly to report Pain, but A/D used mainly to mean the more severe component of Anxiety and Depression. (2) In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level. (3) In valuation, the composite dimension P/D was interpreted to mean Pain, whilst the composite dimension A/D was interpreted to lie between Anxiety and Depression. We conclude that care must be taken when interpreting responses to existing health (or wellbeing) descriptive systems that rely on composite dimensions, and that caution should be applied when designing new ones.",2020,"In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level.",[],['EQ-5D'],"['Pain or Discomfort"" (P/D) and ""Anxiety or Depression"" (A/D', 'severe component of Anxiety and Depression']",[],[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.0204719,"In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McDonald', 'Affiliation': 'University of Birmingham, UK. Electronic address: r.l.mcdonald@bham.ac.uk.'}, {'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'Mullett', 'Affiliation': 'University of Warwick, UK.'}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Tsuchiya', 'Affiliation': 'University of Sheffield, UK.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113323']
1667,32921111,"The effect of attention and interpretation therapy on psychological resilience, cancer-related fatigue, and negative emotions of patients after colon cancer surgery.","BACKGROUND


Colon cancer is the most common malignant tumor of the gastrointestinal tract. This cancer and the related treatments bring a raft of lasting physiological and psychological impacts to patients. This study explored the effects of attention and interpretation therapy (AIT) on improving psychological resilience, cancer-related fatigue (CRF), and negative emotions in patients after colon cancer surgery.
METHODS


Patients who had undergone colon cancer surgery in the Affiliated Hospital of Jiangnan University were selected and randomly allocated into an experimental group and a control group, each with 100 cases. Patients in the control group received routine intervention measures, while the experimental group received an extra 10 weeks of AIT. Before and after 10 weeks of intervention, the effects of intervention were evaluated using the Connor-Davidson Resilience Scale (CD-RISC), Self-Rating Anxiety Scale (SAS), Selfrating Depression Scale (SDS) and the Revised Piper Fatigue Scale (PFS-R).
RESULTS


Before the intervention, there was no statistical difference between the scores of psychological resilience, CRF, and negative emotions between the two groups (P>0.05). We compared the scores before and after the 10 weeks of intervention and found that the scores of psychological resilience of the experimental group were higher than before, and the scores of CRF and negative emotion were lower than before. After the intervention, the psychological resilience score of the experimental group was higher than that of the control group, the CRF and negative emotions scores were lower than those of the control group, and the differences were statistically significant (P<0.05).
CONCLUSIONS


AIT can effectively strengthen the psychological resilience of patients after colon cancer surgery to a certain extent, reduce anxiety and depression, reduce the degree of CRF, and thus improve the patients' quality of life postoperatively.",2020,"After the intervention, the psychological resilience score of the experimental group was higher than that of the control group, the CRF and negative emotions scores were lower than those of the control group, and the differences were statistically significant (P<0.05).
","['patients after colon cancer surgery', 'Patients who had undergone colon cancer surgery in the Affiliated Hospital of Jiangnan University']","['attention and interpretation therapy (AIT', 'attention and interpretation therapy', 'routine intervention measures, while the experimental group received an extra 10 weeks of AIT']","['scores of psychological resilience, CRF, and negative emotions', 'scores of CRF and negative emotion', 'Connor-Davidson Resilience Scale (CD-RISC), Self-Rating Anxiety Scale (SAS), Selfrating Depression Scale (SDS) and the Revised Piper Fatigue Scale (PFS-R', 'psychological resilience, cancer-related fatigue (CRF), and negative emotions', 'CRF and negative emotions scores', 'psychological resilience, cancer-related fatigue, and negative emotions', 'scores of psychological resilience', 'psychological resilience score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0330232', 'cui_str': 'Piper'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.021339,"After the intervention, the psychological resilience score of the experimental group was higher than that of the control group, the CRF and negative emotions scores were lower than those of the control group, and the differences were statistically significant (P<0.05).
","[{'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': ""Yu'e"", 'Initials': 'Y', 'LastName': 'Diao', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Zhixia', 'Initials': 'Z', 'LastName': 'Dong', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Chuanqing', 'Initials': 'C', 'LastName': 'Bao', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China. mollylcy@126.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1370']
1668,32921117,A clinical study of preoperative carbohydrate administration to improve insulin resistance in patients with multiple injuries.,"BACKGROUND


The purpose of this study was to investigate the tolerance and safety of carbohydrate administration to patients with multiple injuries prior to surgery, and to analyze the effects of carbohydrate intake on their immediate insulin resistance (IR), postoperative complications, and length of hospital stay.
METHODS


A total of 125 patients with mild multiple injuries who were admitted to the Emergency Surgery Department of Affiliated Hospital of Nantong University for elective surgery were randomized to administration of either placebo or carbohydrate. Finally, 82 patients (male: 39, female: 43) successfully completed the experiment and collected data. Preoperative general condition, subjective comfort, blood glucose concentration, serum insulin and insulin resistance index (IR) were studied.
RESULTS


The two groups of patients matched in gender, age, body mass index (BMI) (P>0.05). Patients in CHO group treated with carbohydrates three hours before surgery compared with patients treated with preoperative specification. The thirst, hunger and anxiety of the patients in the CHO group were significantly relieved (P<0.05). Blood glucose concentration, serum insulin, and IR were much lower in the CHO group (P<0.05).
CONCLUSIONS


It is a relatively safe approach that patients took carbohydrates 3 hours before surgery, and there was no statistically significant difference in the incidence of postoperative aspiration. Taking carbohydrates before surgery can not only relieve preoperative discomfort, but also reduce postoperative insulin resistance, which is helpful to avoid postoperative metabolic disorder and speed up recovery.",2020,"Blood glucose concentration, serum insulin, and IR were much lower in the CHO group (P<0.05).
","['82 patients (male: 39, female: 43) successfully completed the experiment and collected data', '125 patients with mild multiple injuries who were admitted to the Emergency Surgery Department of Affiliated Hospital of Nantong University for elective surgery', 'patients with multiple injuries', 'patients with multiple injuries prior to surgery']","['carbohydrates', 'carbohydrate', 'preoperative carbohydrate administration', 'placebo or carbohydrate']","['Blood glucose concentration, serum insulin, and IR', 'immediate insulin resistance (IR), postoperative complications, and length of hospital stay', 'incidence of postoperative aspiration', 'insulin resistance', 'hunger and anxiety', 'Preoperative general condition, subjective comfort, blood glucose concentration, serum insulin and insulin resistance index (IR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0026771', 'cui_str': 'Multiple injuries'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",125.0,0.0245766,"Blood glucose concentration, serum insulin, and IR were much lower in the CHO group (P<0.05).
","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Linli', 'Initials': 'L', 'LastName': 'Shan', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Yansong', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Guomin', 'Initials': 'G', 'LastName': 'Mao', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Guiwen', 'Initials': 'G', 'LastName': 'Liang', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China. jhy@ntu.edu.cn.'}, {'ForeName': 'Zhongwei', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China. tdfyhuangzw@163.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1424']
1669,32921123,Effects of tai chi on catheter management and quality of life in tumor patients with PICC at the intermission of chemotherapy: a non-inferiority randomized controlled trial.,"BACKGROUND


Peripherally inserted central catheter (PICC) is widely used in chemotherapy due to its minimal complications and simple wound care. This study explored the effects of tai chi on catheterrelated complications, catheter management ability, and quality of life in tumor patients with PICC at the intermission of chemotherapy.
METHODS


This study was an open parallel trial. A total of 98 patients with malignant tumors who underwent long-term chemotherapy with PICC were randomly divided into an observation group (49 cases) and a control group (49 cases). The control group received grip strength exercise for 3 months, while the observation group received 24 simplified tai chi exercises. The coagulation function, thrombosis rate, self-management ability, and quality of life were compared between the two groups before and after the intervention.
RESULTS


After the intervention, the activated partial thromboplastin time (APTT) and prothrombin time (PT) in the observation group were longer than those in the control group, while fibrinogen (FIB) was lower than that in the control group (all P<0.05). After the intervention, the total score of self-management ability of the observation group was higher than that of the control group (t=2.038, P=0.047), and the scores of exercises ability and quality of daily life with catheters were significantly increased (all P<0.05). In terms of quality of life, scores of role-physical (RP), social functioning (SF), mental health (MH) and role-emotional (RE) in the observation group were higher than those in the control group (all P<0.05), while there was no statistical difference between the bodily pain (BP) scores of the observation group and the control group (P>0.05). The incidence of venous thrombosis in the observation group was lower than that in the control group, the difference was statistically significant ( χ 2 =4.439, P=0.035).
CONCLUSIONS


Tai chi can prevent PICC thrombosis, reduce PICC-related complications, improve selfmanagement ability, and improve quality of life in at-home patients with long-term PICC.",2020,"The incidence of venous thrombosis in the observation group was lower than that in the control group, the difference was statistically significant ( χ 2 =4.439, P=0.035).
","['98 patients with malignant tumors who underwent long-term chemotherapy with PICC', 'tumor patients with PICC at the intermission of chemotherapy']","['grip strength exercise', '24 simplified tai chi exercises', 'tai chi', 'Peripherally inserted central catheter (PICC']","['incidence of venous thrombosis', 'coagulation function, thrombosis rate, self-management ability, and quality of life', 'fibrinogen (FIB', 'scores of exercises ability and quality of daily life with catheters', 'catheter management and quality of life', 'quality of life, scores of role-physical (RP), social functioning (SF), mental health (MH) and role-emotional (RE', 'total score of self-management ability', 'bodily pain (BP) scores', 'activated partial thromboplastin time (APTT) and prothrombin time (PT', 'catheterrelated complications, catheter management ability, and quality of life', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0280440', 'cui_str': 'Catheter management'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",98.0,0.0311705,"The incidence of venous thrombosis in the observation group was lower than that in the control group, the difference was statistically significant ( χ 2 =4.439, P=0.035).
","[{'ForeName': 'Yuehua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': ""Department of PICC clinic, Hai'an People's Hospital, Hai'an, China.""}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Department of Breast and Thyroid Surgery, Jiangyin People's Hospital, Jiangyin, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Department of Oncology, the Second People's Hospital of Wuxi, Wuxi, China. huyue20193@163.com.""}]",Annals of palliative medicine,['10.21037/apm-20-1456']
1670,32930969,Development and Internal Validation of a Discrete Event Simulation Model of Diabetic Kidney Disease Using CREDENCE Trial Data.,"INTRODUCTION


The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) study showed that compared with placebo, canagliflozin 100 mg significantly reduced the risk of major cardiovascular events and adverse renal outcomes in patients with diabetic kidney disease (DKD). We developed a simulation model that can be used to estimate the long-term health and economic consequences of DKD treatment interventions for patients matching the CREDENCE study population.
METHODS


The CREDENCE Economic Model of DKD (CREDEM-DKD) was developed using patient-level data from CREDENCE (which recruited patients with estimated glomerular filtration rate 30 to < 90 mL/min/1.73 m 2 , urinary albumin to creatinine ratio > 300-5000 mg/g, and taking the maximum tolerated dose of a renin-angiotensin-aldosterone system inhibitor). Risk prediction equations were fit for start of maintenance dialysis, doubling of serum creatinine, hospitalization for heart failure, nonfatal myocardial infarction, nonfatal stroke, and all-cause mortality. A micro-simulation model was constructed using these risk equations combined with user-definable kidney transplant event risks. Internal validation was performed by loading the model to replicate the CREDENCE study and comparing predictions with trial Kaplan-Meier estimate curves. External validation was performed by loading the model to replicate a subgroup of the CANagliflozin cardioVascular Assessment Study (CANVAS) Program with patient characteristics that would have qualified for inclusion in CREDENCE.
RESULTS


Risk prediction equations generally fit well and exhibited good concordance, especially for the placebo arm. In the canagliflozin arm, modest underprediction was observed for myocardial infarction, along with overprediction of dialysis, doubling of serum creatinine, and all-cause mortality. Discrimination was strong (0.85) for the renal outcomes, but weaker for the macrovascular outcomes and all-cause mortality (0.60-0.68). The model performed well in internal and external validation exercises.
CONCLUSION


CREDEM-DKD is an important new tool in the evaluation of treatment interventions in the DKD population.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02065791.",2020,"Discrimination was strong (0.85) for the renal outcomes, but weaker for the macrovascular outcomes and all-cause mortality (0.60-0.68).","['recruited patients with estimated glomerular filtration rate 30 to <\u200990\xa0mL', 'patients with diabetic kidney disease (DKD', 'patients matching the CREDENCE study population', 'Diabetic Kidney Disease']","['CREDEM', 'placebo, canagliflozin']","['myocardial infarction', 'macrovascular outcomes and all-cause mortality', 'serum creatinine, hospitalization for heart failure, nonfatal myocardial infarction, nonfatal stroke, and all-cause mortality', 'risk of major cardiovascular events and adverse renal outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]",,0.0330236,"Discrimination was strong (0.85) for the renal outcomes, but weaker for the macrovascular outcomes and all-cause mortality (0.60-0.68).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Willis', 'Affiliation': 'The Swedish Institute for Health Economics, Lund, Sweden. mw@ihe.se.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Asseburg', 'Affiliation': 'ESiOR Oy, Kuopio, Finland.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Slee', 'Affiliation': 'Axio Research Inc, Seattle, WA, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Nilsson', 'Affiliation': 'The Swedish Institute for Health Economics, Lund, Sweden.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Neslusan', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, NJ, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00923-w']
1671,32927677,"Black Soybean Improves Vascular Function and Blood Pressure: A Randomized, Placebo Controlled, Crossover Trial in Humans.","Vascular dysfunction and injurious stimuli such as oxidative stress are closely related to the risk of cardiovascular diseases (CVD). Dietary polyphenols are reported to exert beneficial effects in reducing the risk of CVD. Black soybean has been used as a nutritionally rich food and contains abundant polyphenols in its seed coat and grain. Black soybean has many beneficial physiological activities, and its prevention effects on CVD risk were reported mainly in animal experiments. In this study, we performed a randomized, single blind, placebo controlled, crossover trial to investigate the effect of black soybean consumption on the vascular function in healthy humans. Twenty-two healthy adults aged from 30 to 60 completed the four week trial with daily consumption of about a 40 g test material cookie containing 20 g roasted black soybean powder. Body composition, vascular function, biomarkers for oxidative stress, and polyphenol contents in the urine and the plasma were measured. After ingestion of the black soybean cookie, vascular function, which was evaluated by plethysmogram using a Pulse Analyzer ® , was improved and systolic blood pressure was decreased. Moreover, nitric oxide levels in plasma and urine were increased, while an oxidative stress biomarker, 8-hydroxy-2'-deoxyguanosine level, in the plasma was decreased accompanied by an increase in the concentration of polyphenols derived from black soybean in plasma and urine. These results suggest that the antioxidant activity of black soybean polyphenols and an increase in the nitric oxide level may contribute to the improvement of vascular function. Thus, black soybean is an attractive food material for improvement of vascular function through decreasing oxidative stress by its potent antioxidant activity and increasing the nitric oxide level in healthy humans.",2020,"Moreover, nitric oxide levels in plasma and urine were increased, while an oxidative stress biomarker, 8-hydroxy-2'-deoxyguanosine level, in the plasma was decreased accompanied by an increase in the concentration of polyphenols derived from black soybean in plasma and urine.","['healthy humans', 'Humans', 'Twenty-two healthy adults aged from 30 to 60 completed the four week trial with']","['daily consumption of about a 40 g test material cookie containing 20 g roasted black soybean powder', 'black soybean consumption', 'placebo', 'Black Soybean', 'Placebo']","['nitric oxide level', 'Vascular Function and Blood Pressure', 'vascular function', 'nitric oxide levels in plasma and urine', 'systolic blood pressure', 'Body composition, vascular function, biomarkers for oxidative stress, and polyphenol contents', ""oxidative stress biomarker, 8-hydroxy-2'-deoxyguanosine level""]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C3853210', 'cui_str': 'Cookie'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}]",22.0,0.139485,"Moreover, nitric oxide levels in plasma and urine were increased, while an oxidative stress biomarker, 8-hydroxy-2'-deoxyguanosine level, in the plasma was decreased accompanied by an increase in the concentration of polyphenols derived from black soybean in plasma and urine.","[{'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Yamashita', 'Affiliation': 'Department of Agrobioscience, Graduate School of Agricultural Science, Kobe University, 1-1, Rokkodai-cho, Nada-ku, Kobe 657-8501, Japan.'}, {'ForeName': 'Asuka', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Agrobioscience, Graduate School of Agricultural Science, Kobe University, 1-1, Rokkodai-cho, Nada-ku, Kobe 657-8501, Japan.'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Nanba', 'Affiliation': 'Fujicco Co. Ltd., Research Development, 6-13-4, Minatojima-Nakamachi, Chuo-Ku, Kobe 650-8558, Japan.'}, {'ForeName': 'Shizuka', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Fujicco Co. Ltd., Research Development, 6-13-4, Minatojima-Nakamachi, Chuo-Ku, Kobe 650-8558, Japan.'}, {'ForeName': 'Toshiya', 'Initials': 'T', 'LastName': 'Toda', 'Affiliation': 'Fujicco Co. Ltd., Research Development, 6-13-4, Minatojima-Nakamachi, Chuo-Ku, Kobe 650-8558, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Nakagawa', 'Affiliation': 'Nakagawa Clinic, 3-15-4, Higashisonoda-cho, Amagasaki 661-0953, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ashida', 'Affiliation': 'Department of Agrobioscience, Graduate School of Agricultural Science, Kobe University, 1-1, Rokkodai-cho, Nada-ku, Kobe 657-8501, Japan.'}]",Nutrients,['10.3390/nu12092755']
1672,32927741,Frailty Intervention through Nutrition Education and Exercise (FINE). A Health Promotion Intervention to Prevent Frailty and Improve Frailty Status among Pre-Frail Elderly-A Study Protocol of a Cluster Randomized Controlled Trial.,"The ageing process has been associated with various geriatric issues including frailty. Without early prevention, frailty may cause multiple adverse outcomes. However, it potentially may be reversed with appropriate interventions. The aim of the study is to assess the effectiveness of nutritional education and exercise intervention to prevent frailty among the elderly. A 3-month, single-blind, two-armed, cluster randomized controlled trial of the frailty intervention program among Malaysian pre-frail elderly will be conducted. A minimum of total 60 eligible respondents from 8 clusters (flats) of Program Perumahan Rakyat (PPR) flats will be recruited and randomized to the intervention and control arm. The intervention group will receive a nutritional education and a low to moderate multi-component exercise program. To date, this is the first intervention study that specifically targets both the degree of frailty and an improvement in the outcomes of frailty using both nutritional education and exercise interventions among Malaysian pre-frail elderly. If the study is shown to be effective, there are major potential benefits to older population in terms of preventing transition to frailty. The findings from this trial will potentially provide valuable evidence and serve as a model for similar future interventions designed for elderly Malaysians in the community.",2020,The aim of the study is to assess the effectiveness of nutritional education and exercise intervention to prevent frailty among the elderly.,"['total 60 eligible respondents from 8 clusters (flats) of Program Perumahan Rakyat (PPR) flats', 'Malaysian pre-frail elderly']","['nutritional education and a low to moderate multi-component exercise program', 'frailty intervention program', 'Health Promotion Intervention', 'nutritional education and exercise interventions', 'nutritional education and exercise intervention', 'Frailty Intervention through Nutrition Education and Exercise (FINE']",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}]","[{'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0205232', 'cui_str': 'Fine'}]",[],60.0,0.045271,The aim of the study is to assess the effectiveness of nutritional education and exercise intervention to prevent frailty among the elderly.,"[{'ForeName': 'Nurul Izzati', 'Initials': 'NI', 'LastName': 'Mohd Suffian', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}, {'ForeName': ""Siti Nur 'Asyura"", 'Initials': ""SN'"", 'LastName': 'Adznam', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}, {'ForeName': 'Hazizi', 'Initials': 'H', 'LastName': 'Abu Saad', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}, {'ForeName': 'Yoke Mun', 'Initials': 'YM', 'LastName': 'Chan', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}, {'ForeName': 'Zuriati', 'Initials': 'Z', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}, {'ForeName': 'Noraida', 'Initials': 'N', 'LastName': 'Omar', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}, {'ForeName': 'Muhammad Faizal', 'Initials': 'MF', 'LastName': 'Murat', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}]",Nutrients,['10.3390/nu12092758']
1673,32927752,Cooking for Vitality: Pilot Study of an Innovative Culinary Nutrition Intervention for Cancer-Related Fatigue in Cancer Survivors.,"(1) Background: Cancer-related fatigue (CRF) is one of the most prevalent and distressing side effects experienced by patients with cancer during and after treatment, and this negatively impacts all aspects of quality of life. An increasing body of evidence supports the role of poor nutritional status in the etiology of CRF and of specific diets in mitigating CRF. We designed a group-based two session culinary nutrition intervention for CRF, Cooking for Vitality (C4V), aimed at increasing understanding of how food choices can impact energy levels and establishing basic food preparation and cooking skills as well as the application of culinary techniques that minimize the effort/energy required to prepare meals. The purpose of this pilot mixed-method study was to evaluate: Feasibility of the experimental methods and intervention; acceptability and perceived helpfulness of intervention; and to obtain a preliminary estimate of the effectiveness of the intervention on fatigue (primary outcome), energy, overall disability, and confidence to manage fatigue (secondary outcomes). (2) Methods: Prospective, single arm, embedded mixed-methods feasibility study of cancer survivors with cancer-related fatigue was conducted. Participants completed measures at baseline (T0), immediately following the intervention (T1), and three months after the last session (T2). Qualitative interviews were conducted at T2. (3) Results: Recruitment (70%) and retention (72%) rates along with qualitative findings support the feasibility of the C4V intervention for cancer survivors living with CRF (program length and frequency, ease of implementation, and program flexibility). Acceptability was also high and participants provided useful feedback for program improvements. Fatigue (FACT-F) scores significantly improved from T0-T1 and T0-T2 ( p  < 0.001). There was also a significant decrease in disability scores (WHO-DAS 2.0) from T0-T2 ( p  = 0.006) and an increase in POMS-Vigor (Profile of Mood States) from T0-T1 ( p  = 0.018) and T0-T2 ( p  = 0.013). Confidence in managing fatigue improved significantly from T0-T1 and T0-T2 ( p  < 0.001). (4) Conclusions: The results suggest that the C4V program was acceptable and helpful to patients and may be effective in improving fatigue levels and self-management skills. A randomized controlled trial is required to confirm these findings.",2020,Fatigue (FACT-F) scores significantly improved from T0-T1,"['cancer survivors living with CRF (program length', 'cancer survivors with cancer-related fatigue was conducted', 'Cancer-Related Fatigue in Cancer Survivors']","['T0-T1', 'Innovative Culinary Nutrition Intervention', 'C4V intervention']","['POMS-Vigor (Profile of Mood States', 'Fatigue (FACT-F) scores', 'disability scores', 'fatigue levels and self-management skills', 'fatigue (primary outcome), energy, overall disability, and confidence to manage fatigue (secondary outcomes', 'Acceptability', 'Confidence in managing fatigue']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0591028,Fatigue (FACT-F) scores significantly improved from T0-T1,"[{'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Pritlove', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, ON M5G 1B1, Canada.""}, {'ForeName': 'Geremy', 'Initials': 'G', 'LastName': 'Capone', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2M9, Canada.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Kita', 'Affiliation': 'MD Program, Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gladman', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2M9, Canada.'}, {'ForeName': 'Manjula', 'Initials': 'M', 'LastName': 'Maganti', 'Affiliation': 'Department of Biostatistics, Princess Margaret Cancer Centre, Toronto, ON M5G 2M9, Canada.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Jones', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2M9, Canada.'}]",Nutrients,['10.3390/nu12092760']
1674,32927753,Potato Preload Mitigated Postprandial Glycemic Excursion in Healthy Subjects: An Acute Randomized Trial.,"This study investigated the preload effect of the medium and high glycemic index (GI) potato, as well as the combination of partially hydrolyzed guar gum (HG) and potato, when ingested prior to a rice meal, on the iso-carbohydrate basis. In a randomized crossover trial, 17 healthy female subjects consumed (1) rice; (2) co-ingestion of highly cooked potato (HP), and rice (HP + R); (3) co-ingestion of minimally cooked potato (MP) and rice (MP + R); (4) preload HP prior to rice meal (PHP + R); (5) preload MP prior to rice meal (PMP + R); (6) co-ingestion of partially hydrolyzed guar gum (HG), HP and rice (HG + HP + R); (7) preload HG prior to co-ingestion of HP and rice (PHG + HP + R); (8) co-preload of HG and HP prior to rice (PHG + PHP + R); and (9) preload of HP prior to co-ingestion of HG and rice (PHP + HG + R). Postprandial glycemic response (GR) tests and subjective satiety tests were conducted for each test food. Cooked potato as a preload to a rice meal could significantly cut the acute postprandial glycemic excursion by around 1.0 mmol/L, irrespective of the GI of the preload. Co-preload of partial hydrolyzed guar gum and highly cooked potato (PHG + PHP + R) resulted in improved acute GR in terms of peak glucose value and glycemic excursion compared with either HG preload or HP preload. All the meals with preload showed comparable or improved self-reported satiety. Within an equicarbohydrate exchange framework, both high-GI and medium-GI potato preload decreased the postprandial glycemic excursion in young healthy female subjects. The combination of HG and HP as double preload resulted in better GR than both single HG or HP preload did.",2020,(PHG + PHP + R) resulted in improved acute GR in terms of peak glucose value and glycemic excursion compared with either HG preload or HP preload.,"['young healthy female subjects', '17 healthy female subjects consumed (1) rice; (2', 'Healthy Subjects']","['co-ingestion of highly cooked potato (HP), and rice (HP + R); (3) co-ingestion of minimally cooked potato (MP) and rice (MP + R); (4) preload HP prior to rice meal (PHP + R); (5) preload MP prior to rice meal (PMP + R); (6) co-ingestion of partially hydrolyzed guar gum (HG), HP and rice (HG + HP + R', 'high-GI and medium-GI potato preload', 'Co-preload of partial hydrolyzed guar gum and highly cooked potato', 'preload HG prior to co-ingestion of HP and rice (PHG + HP + R); (8) co-preload of HG and HP prior to rice (PHG + PHP + R); and (9) preload of HP prior to co-ingestion of HG and rice (PHP + HG + R', 'PHG + PHP + R']","['Postprandial glycemic response (GR) tests and subjective satiety tests', 'self-reported satiety', 'Postprandial Glycemic Excursion', 'peak glucose value and glycemic excursion', 'postprandial glycemic excursion', 'acute postprandial glycemic excursion']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0061996', 'cui_str': 'guar gum'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0728938', 'cui_str': 'Partial'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",17.0,0.012354,(PHG + PHP + R) resulted in improved acute GR in terms of peak glucose value and glycemic excursion compared with either HG preload or HP preload.,"[{'ForeName': 'Wenqi', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Yixue', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Anshu', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Xuejiao', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}]",Nutrients,['10.3390/nu12092759']
1675,32931400,"Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy: Investigator-Initiated, Randomized, Open-Label Trial.","PURPOSE


Chemotherapy-induced nausea and vomiting (CINV) is a significant toxicity of chemotherapy. Olanzapine is recommended in adult patients for the prevention of CINV but has not been prospectively investigated in children.
METHODS


This investigator-initiated, randomized, open-label trial evaluated olanzapine in children (ages 5-18 years) scheduled to receive the first cycle of highly emetogenic chemotherapy (HEC). All participants received aprepitant, ondansetron, and dexamethasone during and 2 days after chemotherapy. Participants in the study group additionally received oral olanzapine 0.14 mg/kg/day (rounded to the nearest 2.5 mg; maximum, 10 mg) during the chemotherapy block and 3 days postchemotherapy. The primary objective was to compare complete response (CR) rates (no vomiting and no rescue medication) between the groups in the acute, delayed, and overall periods. Nausea comparison and safety evaluation were secondary and additional objectives, respectively. The collection of outcomes and adverse events was performed daily until the completion of the overall period.
RESULTS


A total of 240 patients underwent randomization. We performed a modified intention-to-treat analysis on 231 patients (116 in the control group and 115 in the study group). A higher proportion of patients in the olanzapine group achieved CR in the acute period (78%  v  59%;  P  = .001), delayed period (74%  v  47%;  P  < .001) and overall period (64%  v  38%;  P  < .001) than in the control group. The proportion of patients with no nausea was significantly higher in the olanzapine group in the acute period (74%  v  52%;  P  < .001), delayed period (74%  v  47%;  P  < .001), and overall period (64%  v  37%;  P  < .001). Grade 1/2 somnolence was greater in the olanzapine group (35%  v  11%;  P  < .001). There was no grade 3/4 somnolence reported.
CONCLUSION


Olanzapine significantly improved CR rates for vomiting in children receiving the first cycle of HEC.",2020,"74%  v  52%;  P  < .001), delayed period (74%  v  47%;  P  < .001), and overall period (64%  v  37%;  P  < .001).","['children (ages 5-18 years', 'children receiving the first cycle of HEC', 'adult patients', '240 patients underwent randomization', 'Children and Adolescents Receiving Highly Emetogenic Chemotherapy', '231 patients (116 in the control group and 115 in the study group']","['olanzapine', 'chemotherapy block and 3 days postchemotherapy', 'Olanzapine', 'aprepitant, ondansetron, and dexamethasone', 'oral olanzapine', 'emetogenic chemotherapy (HEC']","['complete response (CR) rates (no vomiting and no rescue medication', 'Vomiting', 'nausea and vomiting (CINV', 'proportion of patients with no nausea', 'Nausea comparison and safety evaluation', 'CR rates for vomiting', 'Grade 1/2 somnolence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0303407', 'cui_str': 'Indium-115'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0375548', 'cui_str': 'No vomiting'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0423584', 'cui_str': 'No nausea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",240.0,0.111181,"74%  v  52%;  P  < .001), delayed period (74%  v  47%;  P  < .001), and overall period (64%  v  37%;  P  < .001).","[{'ForeName': 'Ramavath D', 'Initials': 'RD', 'LastName': 'Naik', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sreenivas', 'Initials': 'S', 'LastName': 'Vishnubhatla', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vishwajeet', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashwati S', 'Initials': 'AS', 'LastName': 'Pillai', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Dhawan', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00871']
1676,32931496,Biannual azithromycin distribution and child mortality among malnourished children: A subgroup analysis of the MORDOR cluster-randomized trial in Niger.,"BACKGROUND


Biannual azithromycin distribution has been shown to reduce child mortality as well as increase antimicrobial resistance. Targeting distributions to vulnerable subgroups such as malnourished children is one approach to reaching those at the highest risk of mortality while limiting selection for resistance. The objective of this analysis was to assess whether the effect of azithromycin on mortality differs by nutritional status.
METHODS AND FINDINGS


A large simple trial randomized communities in Niger to receive biannual distributions of azithromycin or placebo to children 1-59 months old over a 2-year timeframe. In exploratory subgroup analyses, the effect of azithromycin distribution on child mortality was assessed for underweight subgroups using weight-for-age Z-score (WAZ) thresholds of -2 and -3. Modification of the effect of azithromycin on mortality by underweight status was examined on the additive and multiplicative scale. Between December 2014 and August 2017, 27,222 children 1-11 months of age from 593 communities had weight measured at their first study visit. Overall, the average age among included children was 4.7 months (interquartile range [IQR] 3-6), 49.5% were female, 23% had a WAZ < -2, and 10% had a WAZ < -3. This analysis included 523 deaths in communities assigned to azithromycin and 661 deaths in communities assigned to placebo. The mortality rate was lower in communities assigned to azithromycin than placebo overall, with larger reductions among children with lower WAZ: -12.6 deaths per 1,000 person-years (95% CI -18.5 to -6.9, P < 0.001) overall, -17.0 (95% CI -28.0 to -7.0, P = 0.001) among children with WAZ < -2, and -25.6 (95% CI -42.6 to -9.6, P = 0.003) among children with WAZ < -3. No statistically significant evidence of effect modification was demonstrated by WAZ subgroup on either the additive or multiplicative scale (WAZ < -2, additive: 95% CI -6.4 to 16.8, P = 0.34; WAZ < -2, multiplicative: 95% CI 0.8 to 1.4, P = 0.50, WAZ < -3, additive: 95% CI -2.2 to 31.1, P = 0.14; WAZ < -3, multiplicative: 95% CI 0.9 to 1.7, P = 0.26). The estimated number of deaths averted with azithromycin was 388 (95% CI 214 to 574) overall, 116 (95% CI 48 to 192) among children with WAZ < -2, and 76 (95% CI 27 to 127) among children with WAZ < -3. Limitations include the availability of a single weight measurement on only the youngest children and the lack of power to detect small effect sizes with this rare outcome. Despite the trial's large size, formal tests for effect modification did not reach statistical significance at the 95% confidence level.
CONCLUSIONS


Although mortality rates were higher in the underweight subgroups, this study was unable to demonstrate that nutritional status modified the effect of biannual azithromycin distribution on mortality. Even if the effect were greater among underweight children, a nontargeted intervention would result in the greatest absolute number of deaths averted.
TRIAL REGISTRATION


The MORDOR trial is registered at clinicaltrials.gov NCT02047981.",2020,"Despite the trial's large size, formal tests for effect modification did not reach statistical significance at the 95% confidence level.
","['malnourished children', '523 deaths in communities assigned to', 'to children 1-59 months old over a 2-year timeframe', 'Between December 2014 and August 2017, 27,222 children 1-11 months of age from 593 communities had weight measured at their first study visit']","['azithromycin', 'placebo', 'azithromycin or placebo']","['antimicrobial resistance', 'child mortality', 'mortality rate', 'mortality rates']","[{'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043101', 'cui_str': 'Weights and Measures'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0008083', 'cui_str': 'Mortality, Child'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.296603,"Despite the trial's large size, formal tests for effect modification did not reach statistical significance at the 95% confidence level.
","[{'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center, Niamey, Niger.'}, {'ForeName': 'Ramatou', 'Initials': 'R', 'LastName': 'Maliki', 'Affiliation': 'The Carter Center, Niamey, Niger.'}, {'ForeName': 'Farouk', 'Initials': 'F', 'LastName': 'Manzo', 'Affiliation': 'The Carter Center, Niamey, Niger.'}, {'ForeName': 'Alio K', 'Initials': 'AK', 'LastName': 'Mamkara', 'Affiliation': 'The Carter Center, Niamey, Niger.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'Clinical Research Unit, Department of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Arnold', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, California, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003285']
1677,32931978,"Outcomes of a new slowly resorbable biosynthetic mesh (Phasix™) in potentially contaminated incisional hernias: A prospective, multi-center, single-arm trial.","BACKGROUND


Resorbable biomaterials have been developed to reduce the amount of foreign material remaining in the body after hernia repair over the long-term. However, on the short-term, these resorbable materials should render acceptable results with regard to complications, infections, and reoperations to be considered for repair. Additionally, the rate of resorption should not be any faster than collagen deposition and maturation; leading to early hernia recurrence. Therefore, the objective of this study was to collect data on the short-term performance of a new resorbable biosynthetic mesh (Phasix™) in patients requiring Ventral Hernia Working Group (VHWG) Grade 3 midline incisional hernia repair.
MATERIALS AND METHODS


A prospective, multi-center, single-arm trial was conducted at surgical departments in 15 hospitals across Europe. Patients aged ≥18, scheduled to undergo elective Ventral Hernia Working Group Grade 3 hernia repair of a hernia larger than 10 cm 2  were included. Hernia repair was performed with Phasix™ Mesh in sublay position when achievable. The primary outcome was the rate of surgical site occurrence (SSO), including infections, that required intervention until 3 months after repair.
RESULTS


In total, 84 patients were treated with Phasix™ Mesh. Twenty-two patients (26.2%) developed 32 surgical site occurrences. These included 11 surgical site infections, 9 wound dehiscences, 7 seromas, 2 hematomas, 2 skin necroses, and 1 fistula. No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites. At three months, there were no hernia recurrences.
CONCLUSION


Phasix™ Mesh demonstrated acceptable postoperative surgical site occurrence rates in patients with a Ventral Hernia Working Group Grade 3 hernia. Longer follow-up is needed to evaluate the recurrence rate and the effects on quality of life. This study is ongoing through 24 months of follow-up.",2020,"No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites.","['patients with a Ventral Hernia Working Group Grade 3 hernia', 'Patients aged ≥ 18, scheduled to undergo elective Ventral Hernia Working Group Grade 3 hernia repair of a hernia larger than 10 cm2 were included', '84 patients were treated with Phasix™ Mesh', 'patients requiring Ventral Hernia Working Group (VHWG) Grade 3 midline incisional hernia repair', 'These included 11 surgical site infections, 9 wound dehiscences, 7 seromas, 2 hematomas, 2 skin necroses, and 1 fistula', 'potentially contaminated incisional hernias', '15 hospitals across Europe']","['new slowly resorbable biosynthetic mesh (Phasix™', 'Phasix™ Mesh', 'new resorbable biosynthetic mesh (Phasix™']","['hernia recurrences', 'rate of resorption', 'acceptable postoperative surgical site occurrence rates', 'rate of surgical site occurrences (SSO), including infections, that required intervention until 3 months after repair', 'recurrence rate', 'quality of life', 'surgical site occurrence development', '32 surgical site occurrences']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019326', 'cui_str': 'Hernia of anterior abdominal wall'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439479', 'cui_str': 'sq. cm'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0342971', 'cui_str': 'Repair of incisional hernia'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}]","[{'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",84.0,0.180861,"No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites.","[{'ForeName': 'Mathilde Mj', 'Initials': 'MM', 'LastName': 'van Rooijen', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands. Electronic address: m.vanrooijen@erasmusmc.nl.'}, {'ForeName': 'An P', 'Initials': 'AP', 'LastName': 'Jairam', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Tollens', 'Affiliation': 'Imelda Hospital, Department of General Surgery, Bonheiden, Belgium.'}, {'ForeName': 'Lars N', 'Initials': 'LN', 'LastName': 'Jørgensen', 'Affiliation': 'University of Copenhagen, Bispebjerg Hospital, Department of Surgery, Copenhagen, Denmark.'}, {'ForeName': 'Tammo S', 'Initials': 'TS', 'LastName': 'de Vries Reilingh', 'Affiliation': 'Elkerliek Hospital, Department of Surgery, Helmond, The Netherlands.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Piessen', 'Affiliation': 'University Hospital Lille, Department of Surgery, Lille, France.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Köckerling', 'Affiliation': 'Vivantes Klinikum Spandau, Department of Surgery, Berlin, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Miserez', 'Affiliation': 'University Hospital Leuven, Department of Abdominal Surgery, Leuven, Belgium.'}, {'ForeName': 'Alastair Cj', 'Initials': 'AC', 'LastName': 'Windsor', 'Affiliation': 'University College London Hospital, Department of Colorectal Surgery, London, United Kingdom.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Berrevoet', 'Affiliation': 'University Hospital Ghent, Department of General and Hepatobiliary Surgery, Ghent, Belgium.'}, {'ForeName': 'René H', 'Initials': 'RH', 'LastName': 'Fortelny', 'Affiliation': 'Wilhelminenhospital, Department of General, Visceral and Oncologic Surgery, Vienna, Austria.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Dousset', 'Affiliation': 'Hôpital Cochin, Department of Digestive, Hepatobiliary and Endocrine Surgery, Paris, France.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Woeste', 'Affiliation': 'Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt Am Main, Germany.'}, {'ForeName': 'Henderik L', 'Initials': 'HL', 'LastName': 'van Westreenen', 'Affiliation': 'Isala Zwolle, Department of Surgery, Zwolle, The Netherlands.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Gossetti', 'Affiliation': 'Università di Roma Sapienza, Rome, Italy.'}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Lange', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands; IJsselland Ziekenhuis, Department of Surgery, Capelle Aan Den Ijssel, The Netherlands.'}, {'ForeName': 'Geert Wm', 'Initials': 'GW', 'LastName': 'Tetteroo', 'Affiliation': 'IJsselland Ziekenhuis, Department of Surgery, Capelle Aan Den Ijssel, The Netherlands.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Chirurgische Praxis Cottbus, Cottbus Area, Germany.'}, {'ForeName': 'Leonard F', 'Initials': 'LF', 'LastName': 'Kroese', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Jeekel', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.08.053']
1678,32941439,"""What you say and how you say it"" matters: An experimental evidence of the role of synchronicity, modality, and message valence during smartphone-mediated communication.","Nowadays, smartphone-Mediated Communication (SMC) has become a popular form of social interactions. The present experimental study manipulated three aspects of messaging in a WhatsApp chat as a form of SMC: synchronicity (immediate vs. time-lagged response), modality (with or without emojis), and valence (empathic accurate vs. empathic inaccurate response). The aim of this study was to investigate whether these three aspects had an impact on perceived social support, interpersonal trust, and personality attribution of the communication partner. The partial mediation of perceived social presence (the evaluation of the communication partner's accessibility) and subjective social presence (the perception of being concordant with him/her) was also examined. Participants were 160 young adults, balanced in gender. They were randomly assigned to different the experimental conditions where they engaged in a manipulated WhatsApp chat with a fictitious same-gender communication partner. Post-questionnaire data were analyzed using Structural Equation Modeling. Message valence (empathic accurate response) and modality (with emojis) significantly predicted higher levels of both forms of social presence. Synchronicity (immediate response) predicted higher levels of perceived but not subjective social presence. Social presence, in turn, was positively associated with social support, while subjective, but not perceived social presence, was positively associated with personality attribution. Neither perceived nor subjective social presence were related to interpersonal trust. Our results show that both what is said and how it is said impact the experience of interpersonal relations in SMC.",2020,Message valence (empathic accurate response) and modality (with emojis) significantly predicted higher levels of both forms of social presence.,"['Participants were 160 young adults, balanced in gender']",['smartphone-Mediated Communication (SMC'],"['Message valence (empathic accurate response', 'subjective social presence', 'perceived social support, interpersonal trust, and personality attribution of the communication partner']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]",160.0,0.0152429,Message valence (empathic accurate response) and modality (with emojis) significantly predicted higher levels of both forms of social presence.,"[{'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Petrocchi', 'Affiliation': 'Faculty of Communication, Culture and Society, Università della Svizzera italiana, Lugano, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Marciano', 'Affiliation': 'Faculty of Communication, Culture and Society, Università della Svizzera italiana, Lugano, Switzerland.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Annoni', 'Affiliation': 'Faculty of Communication, Culture and Society, Università della Svizzera italiana, Lugano, Switzerland.'}, {'ForeName': 'Anne-Linda', 'Initials': 'AL', 'LastName': 'Camerini', 'Affiliation': 'Faculty of Communication, Culture and Society, Università della Svizzera italiana, Lugano, Switzerland.'}]",PloS one,['10.1371/journal.pone.0237846']
1679,32942053,Mindfulness-based stress reduction for HIV-associated neurocognitive disorder: Rationale and protocol for a randomized controlled trial in older adults.,"The symptom burden of HIV-associated neurocognitive disorder (HAND) is high among older individuals, and treatment options are limited. Mindfulness-based stress reduction (MBSR) has potential to improve neurocognitive performance, psychosocial wellbeing, and quality of life, but empirical studies in this growing vulnerable population are lacking. In this trial, participants (N = 180) age 55 and older who are living with HIV infection, are on combination antiretroviral therapy with suppressed viral loads, and yet continue to experience behavioral and cognitive symptoms of HAND, are randomized to MBSR or to a waitlist control arm that receives MBSR following a 16-week period of standard care. Primary outcomes (attention, executive function, stress, anxiety, depression, everyday functioning, quality of life) and potential mediators (affect, mindfulness) and moderators (social support, loneliness) are assessed at baseline and weeks 8, 16, and 48 in both groups, with an additional assessment at week 24 (post-MBSR) in the crossover control group. Assessments include self-report and objective measures (e.g., neuropsychological assessment, neurological exam, clinical labs). In addition, a subset of participants (n = 30 per group) are randomly selected to undergo fMRI to evaluate changes in functional connectivity networks and their relationship to changes in neuropsychological outcomes. Forthcoming findings from this randomized controlled trial have the potential to contribute to a growing public health need as the number of older adults with HAND is expected to rise.",2020,"Mindfulness-based stress reduction (MBSR) has potential to improve neurocognitive performance, psychosocial wellbeing, and quality of life, but empirical studies in this growing vulnerable population are lacking.","['older adults', 'HIV-associated neurocognitive disorder', 'participants (N\u202f=\u202f180) age 55 and older who are living with HIV infection, are on combination antiretroviral therapy with suppressed viral loads, and yet continue to experience behavioral and cognitive symptoms of HAND']","['Mindfulness-based stress reduction (MBSR', 'Mindfulness-based stress reduction']","['neurocognitive performance, psychosocial wellbeing, and quality of life', 'symptom burden of HIV-associated neurocognitive disorder (HAND', 'Primary outcomes (attention, executive function, stress, anxiety, depression, everyday functioning, quality of life) and potential mediators (affect, mindfulness) and moderators (social support, loneliness', 'Assessments include self-report and objective measures (e.g., neuropsychological assessment, neurological exam, clinical labs']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",180.0,0.0447385,"Mindfulness-based stress reduction (MBSR) has potential to improve neurocognitive performance, psychosocial wellbeing, and quality of life, but empirical studies in this growing vulnerable population are lacking.","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Addington', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Osher Center for Integrative Medicine, Northwestern University, Chicago, IL, USA. Electronic address: elizabeth.addington@northwestern.edu.'}, {'ForeName': 'Shireen', 'Initials': 'S', 'LastName': 'Javandel', 'Affiliation': 'Memory and Aging Center, Department of Neurology, University of California, San Francisco, California, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'De Gruttola', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Paul', 'Affiliation': 'Missouri Institute of Mental Health, University of Missouri-St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Milanini', 'Affiliation': 'Memory and Aging Center, Department of Neurology, University of California, San Francisco, California, USA.'}, {'ForeName': 'Beau M', 'Initials': 'BM', 'LastName': 'Ances', 'Affiliation': 'Department of Neurology, Washington University in St. Louis, School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Judith T', 'Initials': 'JT', 'LastName': 'Moskowitz', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Osher Center for Integrative Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Valcour', 'Affiliation': 'Memory and Aging Center, Department of Neurology, University of California, San Francisco, California, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106150']
1680,32942085,A Phase 2 Study of AMO-02 (Tideglusib) in Congenital and Childhood-Onset Myotonic Dystrophy Type 1 (DM1).,"BACKGROUND


GSK3β is an intracellular regulatory kinase that is dysregulated in multiple tissues in type 1 myotonic dystrophy, a rare neuromuscular disorder that manifests at any age. AMO-02 (tideglusib) inhibits GSK3β activity in preclinical models of type 1 myotonic dystrophy and promotes cellular maturation as well as normalizes aberrant molecular and behavioral phenotypes. This phase 2 study assessed the pharmacokinetics, safety and tolerability, and preliminary efficacy of AMO-02 in adolescents and adults with congenital and childhood-onset type 1 myotonic dystrophy.
METHODS


Sixteen subjects (aged 13 to 34 years) with congenital and childhood-onset type 1 myotonic dystrophy received 12 weeks of single-blind fixed-dose oral treatment with either 400 mg (n = 8) or 1000 mg (n = 8) AMO-02 (NCT02858908). Blood samples were obtained for pharmacokinetic assessment. Safety assessments, such as laboratory tests and electrocardiograms, as well as efficacy assessments of syndromal, cognitive, and muscular functioning, were obtained.
RESULTS


AMO-02 plasma concentrations conformed to a two-compartment model with first-order absorption and elimination, and dose-dependent increases in exposure (area under the curve) were observed. AMO-02 was generally safe and well-tolerated. No early discontinuations due to adverse events or dose adjustments of AMO-02 occurred. The majority of subjects manifested clinical improvement in their central nervous system and neuromuscular symptoms after 12 weeks of treatment compared with the placebo baseline, with a larger response noted at the 1000 mg/day dose level. AMO-02 exposure (cumulative area under the curve) was significantly correlated (P < 0.01) with change from baseline on several key efficacy assessments.
CONCLUSION


AMO-02 has favorable pharmacokinetic and clinical risk/benefit profiles meriting further study as a potential treatment for congenital and childhood-onset type 1 myotonic dystrophy.",2020,"RESULTS


AMO-02 plasma concentrations conformed to a two-compartment model with first-order absorption and elimination, and dose-dependent increases in exposure (area under the curve) were observed.","['Sixteen subjects (aged 13 to 34 years) with congenital and childhood-onset type 1 myotonic dystrophy received 12\xa0weeks of', 'adolescents and adults with congenital and childhood-onset type 1 myotonic dystrophy']","['AMO-02', 'AMO-02 (Tideglusib', 'single-blind fixed-dose oral treatment with either 400\xa0mg (n\xa0=\xa08) or 1000\xa0mg (n\xa0=\xa08) AMO-02']","['Safety assessments, such as laboratory tests and electrocardiograms, as well as efficacy assessments of syndromal, cognitive, and muscular functioning', 'AMO-02 exposure (cumulative area under the curve', 'central nervous system and neuromuscular symptoms', 'safe and well-tolerated', 'AMO-02 plasma concentrations', 'pharmacokinetics, safety and tolerability']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0027126', 'cui_str': 'Steinert myotonic dystrophy syndrome'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.194485,"RESULTS


AMO-02 plasma concentrations conformed to a two-compartment model with first-order absorption and elimination, and dose-dependent increases in exposure (area under the curve) were observed.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Horrigan', 'Affiliation': 'AMO Pharma Ltd, Wonersh, Surrey, UK. Electronic address: joe.horrigan@amo-pharma.com.'}, {'ForeName': 'Tiago Bernardino', 'Initials': 'TB', 'LastName': 'Gomes', 'Affiliation': 'John Walton Muscular Dystrophy Research Centre, Institute of Genetic Medicine, Newcastle University, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Snape', 'Affiliation': 'AMO Pharma Ltd, Wonersh, Surrey, UK.'}, {'ForeName': 'Nikoletta', 'Initials': 'N', 'LastName': 'Nikolenko', 'Affiliation': 'National Hospital for Neurology and Neurosurgery, Queen Square, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McMorn', 'Affiliation': 'AMO Pharma Ltd, Wonersh, Surrey, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Evans', 'Affiliation': 'AMO Pharma Ltd, Wonersh, Surrey, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Yaroshinsky', 'Affiliation': 'Vital Systems, Inc., Wichita Falls, Texas.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Della Pasqua', 'Affiliation': 'Clinical Pharmacology and Therapeutics, University College London, London, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Oosterholt', 'Affiliation': 'Clinical Pharmacology and Therapeutics, University College London, London, UK.'}, {'ForeName': 'Hanns', 'Initials': 'H', 'LastName': 'Lochmüller', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute; Division of Neurology, Department of Medicine, The Ottawa Hospital; and Brain and Mind Research Institute, University of Ottawa, Ottawa, Canada.""}]",Pediatric neurology,['10.1016/j.pediatrneurol.2020.08.001']
1681,32949370,"Rapidity of CNS Effect on Photoparoxysmal Response for Brivaracetam vs. Levetiracetam: A Randomized, Double-blind, Crossover Trial in Photosensitive Epilepsy Patients.","INTRODUCTION


Both levetiracetam (LEV) and brivaracetam (BRV) eliminate the electroencephalogram photoparoxysmal response (PPR) in the human phase IIa photosensitivity model of epilepsy. The physiochemical properties of BRV differ from those of LEV, having higher potency and lipophilicity plus 10- to 15-fold greater affinity for synaptic vesicle glycoprotein 2A.
OBJECTIVE


We compared the rapidity of the effects of both drugs in the central nervous system (CNS) of patients with photosensitive epilepsy using time to PPR elimination post-intravenous infusion as a pharmacodynamic endpoint.
METHODS


Using a randomized, double-blind, two-period, balanced, crossover design, we tested patients with photosensitive epilepsy with equipotent milligram doses of intravenous LEV 1500 mg versus BRV 100 mg post-15-min intravenous infusion (part 1) and post-5-min intravenous infusion (part 2, same doses). Eight patients per part were deemed sufficient with 80% power to determine a 70% reduction for intravenous BRV:LEV intrapatient time ratio to PPR elimination, with a 0.05 two-sided significance level. Plasma antiseizure medicine concentrations were measured using liquid chromatography/mass spectrometry.
RESULTS


Nine patients [six women; mean age 27.8 years (range 18-42)] completed the study; seven of these participated in both parts 1 and 2. In 31 of 32 instances, patients experienced PPR elimination. In mixed-effects model time analysis, BRV eliminated PPRs more quickly than did LEV (median 2 vs. 7.5 min, respectively). However, no statistically significant difference in BRV:LEV time ratio to PPR elimination was observed for two of our multiple primary outcomes: for the 15-min infusion alone (p = 0.22) or the 5-min infusion alone (p = 0.11). However, BRV was faster when we excluded an outlier patient in part 1 (p = 0.0016). For our remaining primary outcome, parts 1 and 2 data combined, the median intrapatient BRV:LEV time ratio was 0.39 [95% confidence interval (CI) 0.16-0.91], i.e., PPR elimination was 61% faster with BRV, p = 0.039. PPR was completely eliminated in ≤ 2 min in 11 patients with BRV and in four patients with LEV. No period or carryover effects were seen. No serious or severe adverse effects occurred. At PPR elimination (n = 16), median plasma [BRV] was 250 ng/mL (range 30-4100) and median plasma [LEV] was 28.35 μg/mL (range 1-86.7).
CONCLUSION


Outcome studies directly comparing LEV and BRV are needed to define the clinical utility of the response with BRV, which was several minutes faster than that with LEV.
CLINICAL TRIALS


ClinTrials.gov Identifier = NCT03580707; registered 07-09-18.",2020,"However, BRV was faster when we excluded an outlier patient in part 1 (p = 0.0016).","['Photosensitive Epilepsy Patients', 'Nine patients [six women; mean age 27.8\xa0years (range 18-42)] completed the study; seven of these participated in both parts 1 and 2', 'patients with photosensitive epilepsy with equipotent milligram doses of', 'patients with photosensitive epilepsy']","['levetiracetam (LEV) and brivaracetam (BRV', 'Levetiracetam', 'intravenous LEV 1500\xa0mg versus BRV 100\xa0mg post-15-min intravenous infusion (part 1) and post-5-min intravenous infusion']","['PPR elimination', 'median plasma [BRV', 'BRV:LEV time ratio to PPR elimination', 'median plasma [LEV', 'No serious or severe adverse effects', 'Plasma antiseizure medicine concentrations', 'median intrapatient BRV:LEV time ratio', 'PPR', 'BRV', 'intravenous BRV:LEV intrapatient time ratio to PPR elimination']","[{'cui': 'C0393720', 'cui_str': 'Photogenic epilepsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0439210', 'cui_str': 'mg'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3893014', 'cui_str': 'Levetiracetam 1500 MG [Elepsia]'}, {'cui': 'C4083398', 'cui_str': 'Brivaracetam 100 MG'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C1264675', 'cui_str': 'Time ratio'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]",11.0,0.244532,"However, BRV was faster when we excluded an outlier patient in part 1 (p = 0.0016).","[{'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Reed', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, West Virginia University, 1124 Health Science Center North, Morgantown, WV, 26506-9520, USA. ronald.reed@hsc.wvu.edu.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Rosenfeld', 'Affiliation': 'Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, MO, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Lippmann', 'Affiliation': 'Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, MO, USA.'}, {'ForeName': 'Rene M J C', 'Initials': 'RMJC', 'LastName': 'Eijkemans', 'Affiliation': 'Head of Biostatistics and Research Support, Julius Center for Health Sciences and Primary Care, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Dorothee G A', 'Initials': 'DGA', 'LastName': 'Kasteleijn-Nolst Trenité', 'Affiliation': 'Department of Neurosurgery and Epilepsy, University Medical Center, Utrecht University, Utrecht, The Netherlands.'}]",CNS drugs,['10.1007/s40263-020-00761-1']
1682,32946451,Comparative functional survival and equivalent annual cost of 3 long-lasting insecticidal net (LLIN) products in Tanzania: A randomised trial with 3-year follow up.,"BACKGROUND


Two billion long-lasting insecticidal nets (LLINs) have been procured for malaria control. A functional LLIN is one that is present, is in good physical condition, and remains insecticidal, thereby providing protection against vector-borne diseases through preventing bites and killing disease vectors. The World Health Organization (WHO) prequalifies LLINs that remain adequately insecticidal 3 years after deployment. Therefore, institutional buyers often assume that prequalified LLINs are functionally identical with a 3-year lifespan. We measured the lifespans of 3 LLIN products, and calculated their cost per year of functional life, to demonstrate the economic and public health importance of procuring the most cost-effective LLIN product based on its lifespan.
METHODS AND FINDINGS


A randomised double-blinded trial of 3 pyrethroid LLIN products (10,571 nets in total) was conducted at 3 follow-up points: 10 months (August-October 2014), 22 months (August-October 2015), and 36 months (October-December 2016) among 3,393 households in Tanzania using WHO-recommended methods. Primary outcome was LLIN functional survival (LLIN present and in serviceable condition). Secondary outcomes were (1) bioefficacy and chemical content (residual insecticidal activity) and (2) protective efficacy for volunteers sleeping under the LLINs (bite reduction and mosquitoes killed). Median LLIN functional survival was significantly different between the 3 net products (p = 0.001): 2.0 years (95% CI 1.7-2.3) for Olyset, 2.5 years (95% CI 2.2-2.8) for PermaNet 2.0 (hazard ratio [HR] 0.73 [95% CI 0.64-0.85], p = 0.001), and 2.6 years (95% CI 2.3-2.8) for NetProtect (HR = 0.70 [95% CI 0.62-0.77], p < 0.001). Functional survival was affected by accumulation of holes, leading to users discarding nets. Protective efficacy also significantly differed between products as they aged. Equivalent annual cost varied between US$1.2 (95% CI $1.1-$1.4) and US$1.5 (95% CI $1.3-$1.7), assuming that each net was priced identically at US$3. The 2 longer-lived nets (PermaNet and NetProtect) were 20% cheaper than the shorter-lived product (Olyset). The trial was limited to only the most widely sold LLINs in Tanzania. Functional survival varies by country, so the single country setting is a limitation.
CONCLUSIONS


These results suggest that LLIN functional survival is less than 3 years and differs substantially between products, and these differences strongly influence LLIN value for money. LLIN tendering processes should consider local expectations of cost per year of functional life and not unit price. As new LLIN products come on the market, especially those with new insecticides, it will be imperative to monitor their comparative durability to ensure that the most cost-effective products are procured for malaria control.",2020,"Median LLIN functional survival was significantly different between the 3 net products (p = 0.001): 2.0 years (95% CI 1.7-2.3) for Olyset, 2.5 years (95% CI 2.2-2.8) for PermaNet 2.0 (hazard ratio [HR]","['3,393 households in Tanzania using WHO-recommended methods', 'Tanzania', '10,571 nets in total']","['pyrethroid LLIN products', '3 long-lasting insecticidal net (LLIN']","['Protective efficacy', 'Median LLIN functional survival', 'LLIN functional survival (LLIN present and in serviceable condition', 'Equivalent annual cost', 'LLIN functional survival', 'Functional survival', 'bioefficacy and chemical content (residual insecticidal activity) and (2) protective efficacy for volunteers sleeping under the LLINs (bite reduction and mosquitoes killed']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0597329', 'cui_str': 'Pyrethroid'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0243177', 'cui_str': 'chemical content'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0005658', 'cui_str': 'Bite wound'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0026584', 'cui_str': 'Family Culicidae'}, {'cui': 'C0162388', 'cui_str': 'Killing'}]",3.0,0.315453,"Median LLIN functional survival was significantly different between the 3 net products (p = 0.001): 2.0 years (95% CI 1.7-2.3) for Olyset, 2.5 years (95% CI 2.2-2.8) for PermaNet 2.0 (hazard ratio [HR]","[{'ForeName': 'Lena M', 'Initials': 'LM', 'LastName': 'Lorenz', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bradley', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana, United States of America.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Massue', 'Affiliation': 'National Institute for Medical Research, Amani Research Centre, Muheza, Tanzania.'}, {'ForeName': 'Zawadi', 'Initials': 'Z', 'LastName': 'Mageni Mboma', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Pigeon', 'Affiliation': 'Plant Protection Products and Biocides Physico-chemistry and Residues Unit, Agriculture and Natural Environment Department, Walloon Agricultural Research Centre, Gembloux, Belgium.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'Vector Control Product Testing Unit, Ifakara Health Institute, Bagamoyo, Tanzania.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Kilian', 'Affiliation': 'Tropical Health, Montagut, Spain.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Lines', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Kisinza', 'Affiliation': 'National Institute for Medical Research, Amani Research Centre, Muheza, Tanzania.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Overgaard', 'Affiliation': 'Faculty of Science and Technology, Norwegian University of Life Sciences, Ås, Norway.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Moore', 'Affiliation': 'Vector Control Product Testing Unit, Ifakara Health Institute, Bagamoyo, Tanzania.'}]",PLoS medicine,['10.1371/journal.pmed.1003248']
1683,32946885,Training primary care professionals in multimorbidity management: Educational assessment of the eMULTIPAP course.,"Multimorbidity (MM) is a widespread problem and it poses unsolved issues like the healthcare professionals' training. A training curriculum has been proposed, but it has not been sufficiently explored in a clinical context. The eMULTIPAP course is part of the MULTIPAP complex intervention, applied through a pragmatic controlled, cluster randomized clinical trial to general practitioners (GP) and his/her patients with MM with 12 months follow-up. The eMULTIPAP course is based on problem-based learning, constructivism and Ariadne principles. It has been assessed according to the Kirkpatrick model and has shown knowledge improvement and high applicability of learning with more motivation to consider MM in the clinical practice. It has also improved the Medication Appropriateness Index at 6-months and at 12- months. We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.",2020,"We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.",['general practitioners (GP) and his/her patients with MM with 12 months follow-up'],"['Multimorbidity (MM', 'eMULTIPAP']","['Medication Appropriateness Index', ""GP's learning""]","[{'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1535889', 'cui_str': 'Multimorbidity'}]","[{'cui': 'C4046084', 'cui_str': 'Medication Appropriateness Index'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.0184836,"We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.","[{'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Leiva-Fernández', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain. Electronic address: francisca.leiva.sspa@juntadeandalucia.es.'}, {'ForeName': 'Juan Daniel', 'Initials': 'JD', 'LastName': 'Prados-Torres', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain. Electronic address: juand.prados.sspa@juntadeandalucia.es.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Prados-Torres', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain. Electronic address: sprados.iacs@aragon.es.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Del-Cura-González', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; Research Unit, Primary Health Care Management of Madrid, Madrid Health Service, Spain; Public Health and Preventive Medicine Area, University Rey Juan Carlos, Madrid, Spain. Electronic address: isabel.cura@salud.madrid.org.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Castillo-Jimena', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Primary Care Health Centre Coín, Health District Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. Electronic address: marcosc.malaga@gmail.com.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'López-Rodríguez', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; Research Unit, Primary Health Care Management of Madrid, Madrid Health Service, Spain; Public Health and Preventive Medicine Area, University Rey Juan Carlos, Madrid, Spain; Primary Care Health Centre General Ricardos, Madrid Health Service, Spain. Electronic address: juanantonio.lopez@salud.madrid.org.'}, {'ForeName': 'Maria Eloísa', 'Initials': 'ME', 'LastName': 'Rogero-Blanco', 'Affiliation': 'Primary Care Health Centre General Ricardos, Madrid Health Service, Spain. Electronic address: mariaeloisa.rogero@salud.madrid.org.'}, {'ForeName': 'Cristina M', 'Initials': 'CM', 'LastName': 'Lozano-Hernández', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; Research Unit, Primary Health Care Management of Madrid, Madrid Health Service, Spain. Electronic address: cristinamaria.lozano@salud.madrid.org.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'López-Verde', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Primary Care Health Centre Las Delicias, Health District Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. Electronic address: flverde@gmail.com.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Bujalance-Zafra', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Primary Care Health Centre Victoria, Health District Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. Electronic address: mjbujalance@hotmail.com.'}, {'ForeName': 'Maria Victoria', 'Initials': 'MV', 'LastName': 'Pico-Soler', 'Affiliation': 'EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain; Primary Care Health Centre Torrero-La Paz, Aragon Health Service, Zaragoza, Spain. Electronic address: vpico@salud.aragon.es.'}, {'ForeName': 'Luis Andrés', 'Initials': 'LA', 'LastName': 'Gimeno-Feliu', 'Affiliation': 'EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain; Primary Care Health Centre San Pablo. Aragon Health Service, Zaragoza, Spain. Electronic address: lugifel@gmail.com.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Poblador-Plou', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain. Electronic address: bpoblador.iacs@aragon.es.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Martinez-Cañavate', 'Affiliation': 'IAVANTE: Línea de Formación de la Fundación Progreso y Salud, Junta de Andalucía, Spain. Electronic address: teresa.martinezcanavate@juntadeandalucia.es.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Muth', 'Affiliation': 'Institute of General Practice, Johann Wolfgang Goethe University, Frankfurt, Germany. Electronic address: muth@allgemeinmedizin.uni-frankfurt.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Mechanisms of ageing and development,['10.1016/j.mad.2020.111354']
1684,32946924,"Sacituzumab govitecan in previously treated hormone receptor-positive/HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial.","BACKGROUND


Trophoblast cell-surface antigen-2 (Trop-2) is expressed in epithelial cancers, including hormone receptor-positive (HR+) metastatic breast cancer (mBC). Sacituzumab govitecan (SG; Trodelvy®) is an antibody-drug conjugate composed of a humanized anti-Trop-2 monoclonal antibody coupled to SN-38 at a high drug-to-antibody ratio via a unique hydrolyzable linker that delivers SN-38 intracellularly and in the tumor microenvironment. SG was granted accelerated FDA approval for metastatic triple-negative BC treatment in April 2020.
PATIENTS AND METHODS


We analyzed a prespecified subpopulation of patients with HR+/human epidermal growth factor receptor 2-negative (HER2-) HR+/HER2- mBC from the phase I/II, single-arm trial (NCT01631552), who received intravenous SG (10 mg/kg) and whose disease progressed on endocrine-based therapy and at least one prior chemotherapy for mBC. End points included objective response rate (ORR; RECIST version 1.1) assessed locally, duration of response (DOR), clinical benefit rate, progression-free survival (PFS), overall survival (OS), and safety.
RESULTS


Fifty-four women were enrolled between 13 February 2015 and 1 June 2017. Median (range) age was 54 (33-79) years and all received at least two prior lines of therapy for mBC. At data cut-off (1 March 2019), 12 patients were still alive. Key grade ≥3 treatment-related toxicities included neutropenia (50.0%), anemia (11.1%), and diarrhea (7.4%). Two patients discontinued treatment due to treatment-related adverse events. No treatment-related deaths occurred. At a median follow-up of 11.5 months, the ORR was 31.5% [95% confidence interval (CI), 19.5%-45.6%; 17 partial responses]; median DOR was 8.7 months (95% CI 3.7-12.7), median PFS was 5.5 months (95% CI 3.6-7.6), and median OS was 12 months (95% CI 9.0-18.2).
CONCLUSIONS


SG shows encouraging activity in patients with pretreated HR+/HER2- mBC and a predictable, manageable safety profile. Further evaluation in a randomized phase III trial (TROPiCS-02) is ongoing (NCT03901339).
TRIAL REGISTRATION


ClinicalTrials.gov NCT01631552; https://clinicaltrials.gov/ct2/show/NCT01631552.",2020,No treatment-related deaths occurred.,"['Fifty-four women were enrolled between February 13, 2015 and June 1, 2017', 'We analyzed a pre-specified subpopulation of patients with HR+/human epidermal growth factor receptor 2-negative (HER2-) HR+/HER2- mBC from the phase 1/2, single-arm trial (NCT01631552), who received']","['Sacituzumab Govitecan', 'intravenous SG', 'endocrine-based therapy and at least one prior chemotherapy for mBC']","['diarrhea', 'ORR', '17 partial responses); median DOR', 'anemia', 'toxicities included neutropenia', 'median OS', 'median PFS', 'objective response rate (ORR: RECIST 1.1) assessed locally, duration of response (DOR), clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS), and safety']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}]","[{'cui': 'C4086837', 'cui_str': 'sacituzumab govitecan'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0140057', 'cui_str': 'delta Opioid Receptor'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",54.0,0.128403,No treatment-related deaths occurred.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kalinsky', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Columbia University Irving Medical Center-Herbert Irving Comprehensive Cancer Center, New York, USA. Electronic address: kk2693@cumc.columbia.edu.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Diamond', 'Affiliation': 'Department of Medicine, Medical Oncology, University of Colorado Cancer Center, Aurora, USA.'}, {'ForeName': 'L T', 'Initials': 'LT', 'LastName': 'Vahdat', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College, New York, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Juric', 'Affiliation': 'Department of Hematology/Oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Department of Medical Oncology, Texas Oncology, Baylor University Medical Center, US Oncology, Dallas, USA.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Moroose', 'Affiliation': 'Department of Hematology/Oncology, Orlando Health UF Health Cancer Center, Orlando, USA.'}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'Department of Hematology/Oncology, Vanderbilt-Ingram Cancer Center, Nashville, USA.'}, {'ForeName': 'V G', 'Initials': 'VG', 'LastName': 'Abramson', 'Affiliation': 'Department of Hematology/Oncology, Vanderbilt-Ingram Cancer Center, Nashville, USA.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Goldenberg', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, USA.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Sharkey', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Maliakal', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, USA.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Hong', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Goswami', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, USA.'}, {'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Wegener', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bardia', 'Affiliation': 'Department of Hematology/Oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.09.004']
1685,32946978,Sensory attributes of coated tablets: Developing a formal lexicon and sensory wheel.,"The patient's sensory experience when taking an oral medicine is important in the assessment of its palatability, and acceptability. The aim of this study was to develop tools useful for standardisation of sensory assessment of coated tablets: a lexicon and a sensory wheel. Two randomised, double-blind sensory assessments were performed involving 83 and 52 heathy adult volunteers and two sets of coated tablets. By adapting the principles used by food sciences, a free-text description of conventional, bitter-tasting or tasteless, coated tablets was performed. In the first assessment, volunteers described the sensory attributes of the first set of tablets. The attributes collected were then validated using a second set of tablets in a separate study with different volunteers. The appropriateness and semantics of each sensory attribute was analysed. Twenty attributes most relevant for assessment of coated tablets were selected for the lexicon and associated with explicit definitions. A collection of all attributes that could possibly be triggered by coated tablets were organised in the form of a sensory wheel. This study provides a valuable insight into the sensory experience while taking a coated tablet and presents tools which can accelerate the development of palatable medicines.",2020,"Two randomised, double-blind sensory assessments were performed involving 83 and 52 heathy adult volunteers and two sets of coated tablets.",['52 heathy adult volunteers and two sets of coated tablets'],['coated tablets'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}]",[],,0.0459016,"Two randomised, double-blind sensory assessments were performed involving 83 and 52 heathy adult volunteers and two sets of coated tablets.","[{'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Hofmanová', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Batchelor', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, United Kingdom. Electronic address: hannah.batchelor@strath.ac.uk.'}]",International journal of pharmaceutics,['10.1016/j.ijpharm.2020.119883']
1686,32947060,Changing the innate consensus about mesh fixation in trans-abdominal preperitoneal laparoscopic inguinal hernioplasty in adults: Short and long term outcome. Randomized controlled clinical trial.,"INTRODUCTION


Inguinal hernioplasty is the standard treatment for inguinal hernia in adults. Mesh fixation was used to keep mesh in place for which various mesh fixation techniques have been used in laparoscopic inguinal hernia repair in adults, but their effectiveness has remained inconclusive.
AIM OF THE WORK


to evaluate non fixation method of mesh laparoscopic inguinal hernioplasty as safe and effective as regard short and long term outcomes.
PATIENTS AND METHODS


Over the period from July 2013 to July 2018, 798 patients with oblique inguinal hernias undergoing Trans abdominal preperitoneal technique (TAPP) were randomized into 3 groups: Group A; mesh non fixation 266 patients. Group B; tacker mesh fixation 266 patients Group C: Cyanoacrylic tissue glues (Histoacryl) mesh fixation 266 patients. Clinical effects were assessed by the following variables: intraoperative data, postoperative outcome as regard recurrence rate, postoperative pain [on visual analogue score (VAS)], analgesic consumption, operation time, hospital stay, and patient costs. Follow up was 18 months.
RESULTS


There was no statistical difference between groups (A) and Group (C) regarding operative time, postoperative complications, and length of hospital stay and risk of chronic groin pain, postoperative pain score. In Group (B): the postoperative pain and complications were higher. There were 5 cases of hernia recurrence in all groups, but no significant differences among the three groups.
CONCLUSION


Tacker Mesh fixation increased the risk of chronic groin pain. Pain score was higher with tacker mesh fixation. Laparoscopic TAPP inguinal hernia repair without tacker mesh fixation was safe and feasible with no significant increase in recurrence rates. Furthermore, mesh fixation with tacker procedure increased the risk of postoperative complications and patient costs. All ethical approval was given by our Faculty of Medicine medical ethical committee.",2020,"There was no statistical difference between groups (A) and Group (C) regarding operative time, postoperative complications, and length of hospital stay and risk of chronic groin pain, postoperative pain score.","['Trans-abdominal Preperitoneal Laparoscopic Inguinal Hernioplasty in Adults', '266 patients Group C', 'Over the period from July 2013 to July 2018, 798 patients with oblique inguinal hernias undergoing', 'inguinal hernia in adults', '266 patients']","['Cyanoacrylic tissue glues (Histoacryl) mesh fixation', 'Mesh Fixation', 'Inguinal hernioplasty', 'Laparoscopic TAPP inguinal hernia repair without tacker mesh fixation', 'mesh non fixation', 'Mesh fixation', 'tacker mesh fixation', 'Tacker Mesh fixation', 'Trans abdominal preperitoneal technique (TAPP', 'laparoscopic inguinal hernioplasty', 'mechanical tacker fixation']","['risk of chronic groin pain', 'operative time, postoperative complications, and length of hospital stay and risk of chronic groin pain, postoperative pain score', 'postoperative pain and complications', 'intraoperative data, postoperative outcome as regard recurrence rate, postoperative pain [on visual analogue score (VAS)], analgesic consumption, operation time, hospital stay, and patient costs', 'recurrence rates', 'hernia recurrence', 'Pain score', 'risk of postoperative complications and patient costs']","[{'cui': 'C0442170', 'cui_str': 'Preperitoneal approach'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C4284593', 'cui_str': 'Inguinal hernioplasty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0019296', 'cui_str': 'Indirect inguinal hernia'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C4284593', 'cui_str': 'Inguinal hernioplasty'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0163807', 'cui_str': 'tetra-4-amidinophenoxypropane'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",798.0,0.0914316,"There was no statistical difference between groups (A) and Group (C) regarding operative time, postoperative complications, and length of hospital stay and risk of chronic groin pain, postoperative pain score.","[{'ForeName': 'Tamer A A M', 'Initials': 'TAAM', 'LastName': 'Habeeb', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt. Electronic address: tameralnaimy@hotmail.com.'}, {'ForeName': 'Mohammed Mahmoud', 'Initials': 'MM', 'LastName': 'Mokhtar', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Bassem', 'Initials': 'B', 'LastName': 'Sieda', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Gamal', 'Initials': 'G', 'LastName': 'Osman', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Abd-Elrahman M', 'Initials': 'AM', 'LastName': 'Metwalli', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Riad', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Osama M H', 'Initials': 'OMH', 'LastName': 'Khalil', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Mohamed Ibrahim', 'Initials': 'MI', 'LastName': 'Mansour', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Tamer Mohamed', 'Initials': 'TM', 'LastName': 'Elshahidy', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Mohamed I', 'Initials': 'MI', 'LastName': 'Abdelhamid', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Moustafa B', 'Initials': 'MB', 'LastName': 'Mohamed', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.09.013']
1687,32947067,Perspectives of patients and health professionals on important factors influencing rehabilitation following acute pulmonary embolism: A multi-method study.,"BACKGROUND


International guidelines on pulmonary embolism (PE) management and rehabilitation have recently been published. However, the contained recommendation about an efficient follow-up strategy after PE is difficult for health care professionals to implement because limited research exists about what strategies are efficient.
OBJECTIVES


The study aimed to 1) describe and explore perspectives and experiences of health care professionals (HCPs) and patients participating in a post-PE rehabilitation intervention, and 2) provide suggestions for future post-PE management and rehabilitation interventions.
PATIENTS/METHODS


The study was a multi-method study, nested in a larger randomized controlled trial, combining data from two focus group interviews with 10 HCPs, 16 individual interviews with patients, data from exercise diaries and logbooks from HCPs participating in a rehabilitation intervention.
RESULTS


Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations. In terms of rehabilitation, repeatedly testing physical performance, resuming exercise under the guidance and support of specialized personnel, and access to peer support, were considered important for increasing motivation and self-efficacy for engaging in physical activity again.
CONCLUSIONS


This study offers suggestions for key elements to include in post-PE management and rehabilitation interventions, as well as the structuring of care. However, research still needs to be undertaken before solid recommendations for the content and structure of successful post-PE management and rehabilitation can be given.",2020,"Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations.","['two focus group interviews with 10 HCPs, 16 individual interviews with patients, data from exercise diaries and logbooks from HCPs participating in a rehabilitation intervention', 'acute pulmonary embolism']","['health care professionals (HCPs) and patients participating in a post-PE rehabilitation intervention, and 2) provide suggestions for future post-PE management and rehabilitation interventions']",[],"[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2882221', 'cui_str': 'Acute pulmonary embolism'}]","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",[],,0.070874,"Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations.","[{'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Rolving', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark; DEFACTUM, Corporate Quality, Central Denmark Region, Aarhus, Denmark. Electronic address: Nanna.Rolving@rm.dk.'}, {'ForeName': 'Jannie Rhod', 'Initials': 'JR', 'LastName': 'Bloch-Nielsen', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Barbara Christina', 'Initials': 'BC', 'LastName': 'Brocki', 'Affiliation': 'Department of Physical and Occupational Therapy, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Andreasen', 'Affiliation': 'Department of Physical and Occupational Therapy, Aalborg University Hospital, Aalborg, Denmark; Public Health and Epidemiology Group, Department of Health, Science and Technology, Aalborg University, Denmark.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.016']
1688,32947176,Effectiveness of a school-based road safety educational program for lower secondary school students in Denmark: A cluster-randomized controlled trial.,"Road accidents are one of the leading causes of death and injuries among adolescents and young adults. Road safety education programs aim to promote safe traffic behavior through information, skills training or fear appeals. During the last decade, an intervention type using victim testimonials has been developed. These types of programs aim to promote road safety by connecting a personal narrative of choices and consequences to the beliefs and behaviors of the audience. Studies on the effectiveness of this type of road safety programs among youngsters who are not yet drivers are still limited. This study used a cluster-randomized and controlled trial design to examine the effect of a Danish school-based road safety educational program using testimonials for students in lower secondary schools in Denmark on a) knowledge of risks factors in traffic and b) two types of behavior specifically relevant for the pre-driver target group: seatbelt use and safe bicycle behavior. Our analysis sample comprised 1007 students from 57 schools with a matched baseline and four-month follow-up response. Linear regression analyses suggest a small positive effect on the students' knowledge of the three most important risk factors in traffic but not on the age group most at risk. Concerning seatbelt use or overall cycling behavior no effect was found, although a small positive effect was found on helmet use. Neither was the effectiveness modified by gender, parental educational background, or risky cycling behavior at baseline. Although classroom-based interventions using testimonials may have the potential to increase knowledge of risk factors in traffic among adolescents, translating knowledge into safe traffic behavior is challenging. More studies are needed on how to further adapt the intervention to an age group who are not yet drivers. Such research may focus on mechanisms of change including the age-specific relevance of the ambassador's testimonial and on employing strong elements of action guidance.",2020,"Concerning seatbelt use or overall cycling behavior no effect was found, although a small positive effect was found on helmet use.","['students in lower secondary schools in Denmark on a', 'lower secondary school students in Denmark', '1007 students from 57 schools with a matched baseline and four-month follow-up response', 'youngsters who are not yet drivers', 'adolescents and young adults']","['school-based road safety educational program', 'Danish school-based road safety educational program']","['effectiveness modified by gender, parental educational background, or risky cycling behavior']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",1007.0,0.0370321,"Concerning seatbelt use or overall cycling behavior no effect was found, although a small positive effect was found on helmet use.","[{'ForeName': 'Anders Bo', 'Initials': 'AB', 'LastName': 'Bojesen', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Herluf Trolles Gade 11, 1052, København K., Denmark.'}, {'ForeName': 'Signe Boe', 'Initials': 'SB', 'LastName': 'Rayce', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Herluf Trolles Gade 11, 1052, København K., Denmark. Electronic address: sbo@vive.dk.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105773']
1689,32930610,Co-Occurring Psychopathology Moderates Social Skills Improvement in a Randomized Controlled Trial of a Collaborative School-Home Intervention for Children with ADHD.,"OBJECTIVE


Children with ADHD often exhibit marked impairment in their social skills, but evidence-based psychosocial interventions for ADHD have shown limited efficacy in remediating these deficits. Co-occurring psychopathology exacerbates social deficits in children with ADHD and is a plausible moderator of treatment response. To identify factors contributing to variable social skills treatment response, we examined co-occurring externalizing, depression, and anxiety symptoms as moderators of social skills outcomes in a randomized controlled trial of the Collaborative Life Skills (CLS) program, an evidence-based collaborative school-home ADHD intervention.
METHOD


Participants were 159 children with ADHD ( M  age = 8.35 years, 28.3% female) at 27 schools in an urban public school district. Twenty-three schools were randomly assigned to CLS or usual services, with an additional four schools assigned to Spanish-adapted CLS or usual services. Multi-informant measures of co-occurring psychopathology and social skills were collected at baseline and post-treatment.
RESULTS


Parent-rated externalizing and depression symptoms moderated treatment effects on social skills, whereby higher symptomatology in each domain was unrelated to social skills improvement in the CLS group but predicted worsening social skills in response to usual services. In contrast, teacher-rated anxiety moderated treatment effects on social skills, whereby higher anxiety predicted greater social skills improvement in response to CLS but was unrelated to social skills outcomes following usual services.
CONCLUSIONS


Findings reflect novel evidence that child psychopathology domains exhibit unique moderating effects on social skills treatment response in children with ADHD. We discuss implications for optimizing evidence-based interventions to target social impairment in this population.",2020,"In contrast, teacher-rated anxiety moderated treatment effects on social skills, whereby higher anxiety predicted greater social skills improvement in response to CLS but was unrelated to social skills outcomes following usual services.
","['children with ADHD', 'Children with ADHD', 'Twenty-three schools', 'Participants were 159 children with ADHD ( M  age\xa0=\xa08.35\xa0years, 28.3% female) at 27 schools in an urban public school district']","['Collaborative Life Skills (CLS) program, an evidence-based collaborative school-home ADHD intervention', 'CLS or usual services, with an additional four schools assigned to Spanish-adapted CLS or usual services', 'Collaborative School-Home Intervention', 'Co-Occurring Psychopathology Moderates Social Skills']","['social skills', 'worsening social skills', 'Multi-informant measures of co-occurring psychopathology and social skills']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0915905', 'cui_str': 'IS 159'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0557800', 'cui_str': 'Public school'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",159.0,0.0397701,"In contrast, teacher-rated anxiety moderated treatment effects on social skills, whereby higher anxiety predicted greater social skills improvement in response to CLS but was unrelated to social skills outcomes following usual services.
","[{'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Morgan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, San Francisco.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Dvorsky', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, San Francisco.'}, {'ForeName': 'Jocelyn I', 'Initials': 'JI', 'LastName': 'Meza', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles.'}, {'ForeName': 'Lauren T', 'Initials': 'LT', 'LastName': 'Schumacher', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, San Francisco.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Pfiffner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, San Francisco.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2020.1815206']
1690,32924954,A Mobile Gaming Intervention for Persons on Pre-Exposure Prophylaxis: Protocol for Intervention Development and Randomized Controlled Trial.,"BACKGROUND


In the United States, young minority men who have sex with men (MSM) are the most likely to become infected with HIV. Pre-exposure prophylaxis (PrEP) is an efficacious and promising prevention strategy. However, PrEP's safety and effectiveness can be greatly compromised by suboptimal adherence to treatment. To maximize the positive impact of PrEP, it is necessary to combine its prescription with cost-effective behavioral interventions that promote adherence and decrease HIV risk behaviors. In this project, we developed a theoretically informed app/gaming intervention to engage young MSM in learning information, practicing behaviors, and improving motivation for HIV preventative behaviors and PrEP adherence.
OBJECTIVE


The goal of this project was to develop and test a cutting-edge, engaging, and entertaining app/gaming intervention for improving adherence to PrEP and building HIV prevention knowledge, skills, and behavior.
METHODS


This study was conducted in two phases. In the developmental phase, we conducted qualitative interviews with young MSM (n=20) to guide the development of the gaming intervention. In the randomized controlled trial, we tested the preliminary efficacy of the gaming intervention compared to a comparison condition among young MSM. Subjects were recruited from the University of Mississippi Medical Center HIV/STI testing clinics (n=60).
RESULTS


Institutional review board approval was received in February 2015. Research activities began in June 2015 and are still ongoing.
CONCLUSIONS


This app/gaming intervention aimed to improve PrEP adherence and HIV preventative behaviors in young MSM. Engaging young MSM in learning information, practicing behaviors, and improving motivation for increased adherence to PrEP has the potential to decrease HIV seroconversion. It is important to develop interventions that are enjoyable, engaging, and easily incorporated into clinical settings.
TRIAL REGISTRATION


ClinicalTrials.gov RCT02611362; https://tinyurl.com/y65gkuwr.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18640.",2020,"Engaging young MSM in learning information, practicing behaviors, and improving motivation for increased adherence to PrEP has the potential to decrease HIV seroconversion.","['Subjects were recruited from the University of Mississippi Medical Center HIV/STI testing clinics (n=60', 'young minority men who have sex with men (MSM', 'young MSM']","['Mobile Gaming Intervention', 'cutting-edge, engaging, and entertaining app/gaming intervention', 'gaming intervention']","['PrEP adherence and HIV preventative behaviors', 'HIV risk behaviors']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0026221', 'cui_str': 'Mississippi'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",,0.0907411,"Engaging young MSM in learning information, practicing behaviors, and improving motivation for increased adherence to PrEP has the potential to decrease HIV seroconversion.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Whiteley', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School, Brown University, Providence, RI, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Olsen', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School, Brown University, Providence, RI, United States.'}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Mena', 'Affiliation': 'Department of Population Health Science, University of Mississippi Medical Center, Jackson, MS, United States.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Haubrick', 'Affiliation': 'Department of Psychiatry, Rhode Island Hospital, Providence, RI, United States.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Craker', 'Affiliation': 'Department of Psychiatry, Rhode Island Hospital, Providence, RI, United States.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Hershkowitz', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School, Brown University, Providence, RI, United States.'}, {'ForeName': 'Larry K', 'Initials': 'LK', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School, Brown University, Providence, RI, United States.'}]",JMIR research protocols,['10.2196/18640']
1691,32926507,First-line pembrolizumab vs chemotherapy in metastatic non-small-cell lung cancer: KEYNOTE-024 Japan subset.,"This prespecified subanalysis of the global, randomized controlled phase III KEYNOTE-024 study of pembrolizumab vs chemotherapy in previously untreated metastatic non-small-cell lung cancer without EGFR/ALK alterations and a programmed death ligand 1 (PD-L1) tumor proportion score of 50% or higher evaluated clinical outcomes among patients enrolled in Japan. Treatment consisted of pembrolizumab 200 mg every 3 weeks (35 cycles) or platinum-based chemotherapy (four to six cycles). The primary end-point was progression-free survival; secondary end-points included overall survival and safety. Of 305 patients randomized in KEYNOTE-024 overall, 40 patients were enrolled in Japan (all received treatment: pembrolizumab, n = 21; chemotherapy, n = 19). Median progression-free survival was 41.4 (95% confidence interval [CI], 4.2-42.5) months with pembrolizumab and 4.1 (95% CI, 2.8-8.3) months with chemotherapy (hazard ratio [HR], 0.27 [95% CI, 0.11-0.65]; one-sided, nominal P = .001). Median overall survival was not reached (NR) (95% CI, 22.9-NR) and 21.5 (95% CI, 5.2-35.0) months, respectively (HR, 0.39 [95% CI, 0.17-0.91]; one-sided, nominal P = .012). Treatment-related adverse events occurred in 21/21 (100%) pembrolizumab-treated and 18/19 (95%) chemotherapy-treated patients; eight patients (38%) and nine patients (47%), respectively, had grade 3-5 events. Immune-mediated adverse events and infusion reactions occurred in 11 pembrolizumab-treated patients (52%) and four chemotherapy-treated patients (21%), respectively; four patients (19%) and one patient (5%), respectively, had grade 3-5 events. Consistent with results from KEYNOTE-024 overall, first-line pembrolizumab improved progression-free survival and overall survival vs chemotherapy with manageable safety among Japanese patients with metastatic non-small-cell lung cancer without EGFR/ALK alterations and a PD-L1 tumor proportion score of 50% or higher. The trial is registered with Clinicaltrials.gov: NCT02142738.",2020,"Immune-mediated adverse events and infusion reactions occurred in 11 patients (52%) and 4 patients (21%), respectively; 4 patients (19%) and 1 patient (5%), respectively, had grade 3-5 events.","['305 patients randomized in KEYNOTE-024 overall, 40 patients were enrolled in Japan (all received treatment: pembrolizumab, n = 21; chemotherapy, n = 19', 'Metastatic Non-Small-Cell Lung Cancer', 'Japanese patients with metastatic non-small-cell lung cancer', 'previously untreated metastatic non-small-cell lung cancer without EGFR/ALK alterations and a PD-L1 tumor proportion score ≥50% evaluated clinical outcomes among patients enrolled in Japan']","['pembrolizumab versus chemotherapy', 'pembrolizumab', 'First-Line Pembrolizumab Versus Chemotherapy', 'platinum-based chemotherapy']","['overall survival and safety', 'adverse events', 'Median overall survival', 'progression-free survival', 'progression-free survival and overall survival', 'Immune-mediated adverse events and infusion reactions', 'Median progression-free survival']","[{'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C4087225', 'cui_str': 'Immune-mediated adverse reaction'}, {'cui': 'C2368034', 'cui_str': 'Adverse reaction to drug or medicament administered by infusion'}]",305.0,0.576266,"Immune-mediated adverse events and infusion reactions occurred in 11 patients (52%) and 4 patients (21%), respectively; 4 patients (19%) and 1 patient (5%), respectively, had grade 3-5 events.","[{'ForeName': 'Miyako', 'Initials': 'M', 'LastName': 'Satouchi', 'Affiliation': 'Department of Thoracic Oncology, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Kaname', 'Initials': 'K', 'LastName': 'Nosaki', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Shuntougun, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Aoe', 'Affiliation': 'Department of Medical Oncology, National Hospital Organization Yamaguchi Ube Medical Center, Ube, Japan.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Kurata', 'Affiliation': 'Department of Thoracic Oncology, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Akimasa', 'Initials': 'A', 'LastName': 'Sekine', 'Affiliation': 'Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Kanagawa, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Horiike', 'Affiliation': 'Department of Thoracic Medical Oncology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Fukuhara', 'Affiliation': 'Department of Respiratory Medicine, Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Miyagi, Japan.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Umemura', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Saka', 'Affiliation': 'Department of Respiratory Medicine and Medical Oncology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Okamoto', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Sakai', 'Affiliation': 'Department of Thoracic Oncology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Kazuma', 'Initials': 'K', 'LastName': 'Kishi', 'Affiliation': 'Department of Respiratory Medicine, Respiratory Center, Totanomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Katakami', 'Affiliation': 'Division of Integrated Oncology, Institute of Biomedical Research and Innovation Hospital, Kobe, Japan.'}, {'ForeName': 'Hidehito', 'Initials': 'H', 'LastName': 'Horinouchi', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Toyoaki', 'Initials': 'T', 'LastName': 'Hida', 'Affiliation': 'Department of Thoracic Oncology, Aichi Cancer Center, Aichi, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Okamoto', 'Affiliation': ""Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.""}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Atagi', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Ohira', 'Affiliation': 'Department of Surgery, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Shi Rong', 'Initials': 'SR', 'LastName': 'Han', 'Affiliation': 'MSD, K.K., Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Noguchi', 'Affiliation': 'MSD, K.K., Tokyo, Japan.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ebiana', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Katsuyuki', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan.'}]",Cancer science,['10.1111/cas.14647']
1692,32927371,Neural affective mechanisms associated with treatment responsiveness in veterans with PTSD and comorbid alcohol use disorder.,"Post-traumatic stress disorder (PTSD) is associated with neuro-physiological abnormalities reflecting increased anticipatory anxiety and reactivity to traumatic cues. It remains unclear whether neural mechanisms associated with PTSD treatment responsiveness, i.e. hyperactivation of the affective salience network in the brain, extend to a comorbid PTSD and substance use disorder population. Thirty-one Veterans with PTSD and co-occurring alcohol use disorder (AUD) were randomly assigned to either prolonged exposure or a non-exposure based treatment. They completed an affective anticipation task while undergoing fMRI, immediately prior and after completing treatment. After controlling for type and length of treatment, larger reduction of PTSD symptoms was associated with decreased anticipatory activation to negative trauma-related cues in the right pre-Supplementary Motor Area (pre-SMA), a region associated with emotion regulation. Smaller reduction in PTSD severity was associated with enhanced anticipatory activation to those cues within the right para-hippocampal region, an affective processing region. Our findings suggest that post-treatment reductions in anticipatory reactivity to trauma-related cues in the pre-SMA and para-hippocampal area are associated with larger PTSD symptom reduction in individuals with co-occurring PTSD and AUD. These results may offer neurofeedback training targets as an alternative to or enhancement of other PTSD treatment modalities in this population.",2020,"Smaller reduction in PTSD severity was associated with enhanced anticipatory activation to those cues within the right para-hippocampal region, an affective processing region.","['veterans with PTSD and comorbid alcohol use disorder', 'Thirty-one Veterans with PTSD and co-occurring alcohol use disorder (AUD', 'Post-traumatic stress disorder (PTSD']",['prolonged exposure or a non-exposure based treatment'],"['PTSD symptoms', 'PTSD severity']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",31.0,0.00943451,"Smaller reduction in PTSD severity was associated with enhanced anticipatory activation to those cues within the right para-hippocampal region, an affective processing region.","[{'ForeName': 'Katia M', 'Initials': 'KM', 'LastName': 'Harlé', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States. Electronic address: kharle@ucsd.edu.'}, {'ForeName': 'Alan N', 'Initials': 'AN', 'LastName': 'Simmons', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States.'}, {'ForeName': 'Andrea D', 'Initials': 'AD', 'LastName': 'Spadoni', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111172']
1693,32927895,Eating Fast Has a Significant Impact on Glycemic Excursion in Healthy Women: Randomized Controlled Cross-Over Trial.,"Epidemiological studies have shown that self-reported fast eating increases the risk of diabetes and obesity. Our aim was to evaluate the acute effect of fast eating on glycemic parameters through conducting a randomized controlled cross-over study with young healthy women. Nineteen healthy women wore a flash glucose monitoring system for 6 days. Each participant consumed identical test meals with a different eating speed of fast eating (10 min) or slow eating (20 min) on the 4th or the 5th day. The daily glycemic parameters were compared between the 2 days. The mean amplitude of glycemic excursion (MAGE; fast eating 3.67 ± 0.31 vs. slow eating 2.67 ± 0.20 mmol/L,  p  < 0.01), incremental glucose peak (IGP; breakfast 2.30 ± 0.19 vs. 1.71 ± 0.12 mmol/L,  p  < 0.01, lunch 4.06 ± 0.33 vs. 3.13 ± 0.28 mmol/L,  p  < 0.01, dinner 3.87 ± 0.38 vs. 2.27 ± 0.27 mmol/L,  p  < 0.001), and incremental area under the curve for glucose of dinner 2 h (IAUC; 256 ± 30 vs. 128 ± 18 mmol/L × min,  p  < 0.001) for fast eating were all significantly higher than those for slow eating. The results suggest that fast eating is associated with higher glycemic excursion in healthy women.",2020,"p  < 0.001), and incremental area under the curve for glucose of dinner 2 h (IAUC; 256 ± 30 vs. 128 ± 18 mmol/L × min,  ","['Nineteen healthy women wore a', 'healthy women', 'Healthy Women', 'young healthy women']","['identical test meals with a different eating speed of fast eating (10 min) or slow eating', 'flash glucose monitoring system']","['glycemic excursion', 'daily glycemic parameters', 'fast eating', 'Glycemic Excursion', 'incremental glucose peak', 'mean amplitude of glycemic excursion']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",19.0,0.0534393,"p  < 0.001), and incremental area under the curve for glucose of dinner 2 h (IAUC; 256 ± 30 vs. 128 ± 18 mmol/L × min,  ","[{'ForeName': 'Yuuki', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': ""Department of Food and Nutrition, Faculty of Home Economics, Kyoto Women's University, 35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto 605-8501, Japan.""}, {'ForeName': 'Shizuo', 'Initials': 'S', 'LastName': 'Kajiyama', 'Affiliation': 'Kajiyama Clinic, Kyoto Gojyo Clinic Build. 20-1, Higasionnmaeda-cho, Nishinanajyo, Shimogyo-ku, Kyoto 600-8898, Japan.'}, {'ForeName': 'Ayasa', 'Initials': 'A', 'LastName': 'Nitta', 'Affiliation': ""Department of Food and Nutrition, Faculty of Home Economics, Kyoto Women's University, 35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto 605-8501, Japan.""}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Miyawaki', 'Affiliation': ""Department of Food and Nutrition, Faculty of Home Economics, Kyoto Women's University, 35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto 605-8501, Japan.""}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Matsumoto', 'Affiliation': ""Department of Food and Nutrition, Faculty of Home Economics, Kyoto Women's University, 35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto 605-8501, Japan.""}, {'ForeName': 'Neiko', 'Initials': 'N', 'LastName': 'Ozasa', 'Affiliation': 'Graduate School of Medicine, Kyoto University, 54, Kawahara-cho, Syogoin, Sakyo-ku, Kyoto 606-8507, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Kajiyama', 'Affiliation': 'Japanese Red Cross Kyoto Daini Hospital, 355-5, Kamanza, Marutamachi, Kamigyo-ku, Kyoto 602-8026, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Fukui', 'Affiliation': 'Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.'}, {'ForeName': 'Saeko', 'Initials': 'S', 'LastName': 'Imai', 'Affiliation': ""Department of Food and Nutrition, Faculty of Home Economics, Kyoto Women's University, 35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto 605-8501, Japan.""}]",Nutrients,['10.3390/nu12092767']
1694,32931763,Spinal Manipulation for Subacute and Chronic Lumbar Radiculopathy: A Randomized Controlled Trial.,"OBJECTIVE


We evaluated the efficacy of spinal manipulation for the management of nonacute lumbar radiculopathy.
METHODS


In a university hospital we performed a randomized controlled trial with 2 parallel arms. Patients (n = 44) with unilateral radicular low back pain lasting more than 4 weeks were randomly allocated to manipulation and control groups. The primary outcome was the intensity of the low back pain on a visual analog scale. The secondary outcome was the Oswestry Disability Questionnaire score. We also measured spinal ranges of motion. The assessments were carried out at the baseline, immediately after intervention, and at 3 months' follow-up. All patients underwent physiotherapy. The manipulation group received three sessions of manipulation therapy 1 week apart. For manipulation, we used Robert Maigne's technique.
RESULTS


Both groups experienced a decrease in back and leg pain significantly (all P ≤ 0.003). However, only the manipulation group showed significantly favorable results in the Oswestry scores (P < 0.001), and the straight leg raise test (P = 0.001). All ranges of motion increased significantly with manipulation (all P < 0.001), but the control group showed favorable results only in right and left rotations and in extension (all P < 0.001). Between-group analyses showed significantly better outcomes for manipulation in all measurements (all P ≤ 0.009) with large effect sizes.
CONCLUSION


Spinal manipulation improves the results of physiotherapy over a period of 3 months for patients with subacute or chronic lumbar radiculopathy.",2020,"However, only the manipulation group showed significantly favorable results in the Oswestry scores (p<0.001), and the straight leg raise test (p=0.001).","['subacute and chronic lumbar radiculopathy', 'patients with subacute or chronic lumbar radiculopathy', 'Patients (n=44) with unilateral radicular low back pain lasting more than 4 weeks']","['spinal manipulation', 'physiotherapy', 'Spinal manipulation']","['intensity of the low back pain on a visual analog scale', 'Oswestry scores', 'straight leg raise test', 'Oswestry Disability Questionnaire score', 'back and leg pain']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1263855', 'cui_str': 'Lumbar radiculopathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1288281', 'cui_str': 'Lasègue test'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}]",44.0,0.0964355,"However, only the manipulation group showed significantly favorable results in the Oswestry scores (p<0.001), and the straight leg raise test (p=0.001).","[{'ForeName': 'Seyedezahra Hosseini', 'Initials': 'SH', 'LastName': 'Ghasabmahaleh', 'Affiliation': 'Aja University of Medical Sciences, Western Fatemi, Tehran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Rezasoltani', 'Affiliation': 'Aja University of Medical Sciences, Western Fatemi, Tehran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Dadarkhah', 'Affiliation': 'Aja University of Medical Sciences, Western Fatemi, Tehran.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Hamidipanah', 'Affiliation': 'Aja University of Medical Sciences, Western Fatemi, Tehran.'}, {'ForeName': 'Reza Kazempour', 'Initials': 'RK', 'LastName': 'Mofrad', 'Affiliation': 'Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sharif', 'Initials': 'S', 'LastName': 'Najafi', 'Affiliation': 'Aja University of Medical Sciences, Western Fatemi, Tehran. Electronic address: sh.najafi@ajaums.ac.ir.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.08.005']
1695,32932584,Hyperhomocysteinemia Induced by Methionine Excess Is Effectively Suppressed by Betaine in Geese.,"The objective of our study was to investigate the effects of excess Methionine (Met) on the growth performance, serum homocysteine levels, apoptotic rates, and Bax and Bcl-2 protein levels in geese and to study the role of Bet (betaine) in relieving excess Met-induced hyperhomocysteinemia (HHcy). In this study, 150 healthy male 14-day-old Yangzhou geese of similar body weight were randomly distributed into three groups with five replicates per treatment and 10 geese per replicate: the control group (fed a control diet), the Met toxicity group (fed the control diet +1% Met), and the Bet detoxification group (fed the control diet +1% Met +0.2% Bet). At 28, 49, and 70 d of age, the geese in the Met toxicity group had significantly lower body weights than those in the control group ( p  < 0.05). The serum homocysteine levels in geese at 70 d of age in the detoxification group were significantly lower than those in the Met toxicity group ( p  < 0.05). Compared with the control, Met significantly increased cardiomyocyte apoptosis rates, while Bet reduced them. In conclusion, our results suggest that excess methionine reduces body weight induced by myocardial apoptosis, and Bet can be used to effectively lower plasma homocysteine levels.",2020,The serum homocysteine levels in geese at 70 d of age in the detoxification group were significantly lower than those in the Met toxicity group ( p  < 0.05).,['150 healthy male 14-day-old Yangzhou geese of similar body weight'],"['control group (fed a control diet), the Met toxicity group (fed the control diet +1% Met), and the Bet detoxification group (fed the control diet +1% Met +0.2% Bet', 'excess Methionine (Met']","['growth performance, serum homocysteine levels, apoptotic rates, and Bax and Bcl-2 protein levels', 'body weights', 'cardiomyocyte apoptosis rates', 'serum homocysteine levels', 'body weight', 'plasma homocysteine levels']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0017225', 'cui_str': 'Anser'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1278080', 'cui_str': 'Serum homocysteine measurement'}, {'cui': 'C0219474', 'cui_str': 'Bax Protein'}, {'cui': 'C4042483', 'cui_str': 'BCL2 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0225828', 'cui_str': 'Cardiac myocyte'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C1278165', 'cui_str': 'Plasma homocysteine measurement'}]",150.0,0.0147092,The serum homocysteine levels in geese at 70 d of age in the detoxification group were significantly lower than those in the Met toxicity group ( p  < 0.05).,"[{'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Joint International Research Laboratory of Agriculture and Agri-Product Safety of the Ministry of Education of China, Yangzhou University, Yangzhou 225009, Jiangsu Province, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'College of Animal Science and Technology, Yangzhou University, Yangzhou 225009, Jiangsu Province, China.'}, {'ForeName': 'Jinjin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'College of Animal Science and Technology, Yangzhou University, Yangzhou 225009, Jiangsu Province, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'College of Animal Science and Technology, Yangzhou University, Yangzhou 225009, Jiangsu Province, China.'}, {'ForeName': 'Haiming', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'College of Animal Science and Technology, Yangzhou University, Yangzhou 225009, Jiangsu Province, China.'}, {'ForeName': 'Zhiyue', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Joint International Research Laboratory of Agriculture and Agri-Product Safety of the Ministry of Education of China, Yangzhou University, Yangzhou 225009, Jiangsu Province, China.'}]",Animals : an open access journal from MDPI,['10.3390/ani10091642']
1696,32932611,"Pre-Competition Weight Loss Models in Taekwondo: Identification, Characteristics and Risk of Dehydration.","Athletes use different combinations of weight loss methods during competition preparation. The aim of this study was to identify and characterize pre-competition weight loss models, which describe these combinations. The second aim was to determine if any existing model pose a higher risk of severe dehydration and whether any of the models could be continued as a lower-risk option. The third aim was to explore whether athletes who used different weight management strategies could be differentiated based on age, sex, training experience or anthropometric parameters. Study participants were randomly selected from Olympic taekwondo competitors and 192 athletes were enrolled. Active (47% weight-reducing athletes), passive (31%) and extreme (22%) models have been described. In the extreme model, athletes combined the highest number of different weight loss methods (3.9 ± 0.9 methods vs. 2.4 ± 0.9 in active and 1.5 ± 0.6 in passive), reduced significantly more body mass than others (6.7 ± 3.5% body mass vs. 4.3 ± 1.9% and 4.5 ± 2.4%;  p  < 0.01) and all of them used methods with the highest risk of severe dehydration. The active and passive models could be continued as a lower-risk option, if athletes do not combine dehydrating methods and do not prolong the low energy availability phase. The extreme model carried the highest risk of severe dehydration. Every fifth weight-reducing taekwondo athlete may have been exposed to the adverse effects of acute weight loss. Taekwondo athletes, regardless of age, sex, training experience and anthropometric parameters, lose weight before the competition and those characteristics do not differentiate them between models.",2020,The second aim was to determine if any existing model pose a higher risk of severe dehydration and whether any of the models could be continued as a lower-risk option.,['Study participants were randomly selected from Olympic taekwondo competitors and 192 athletes were enrolled'],[],['body mass'],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",[],"[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",192.0,0.0386025,The second aim was to determine if any existing model pose a higher risk of severe dehydration and whether any of the models could be continued as a lower-risk option.,"[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Janiszewska', 'Affiliation': 'Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury in Olsztyn, Słoneczna 45F Str., 10-718 Olsztyn, Poland.'}, {'ForeName': 'Katarzyna E', 'Initials': 'KE', 'LastName': 'Przybyłowicz', 'Affiliation': 'Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury in Olsztyn, Słoneczna 45F Str., 10-718 Olsztyn, Poland.'}]",Nutrients,['10.3390/nu12092793']
1697,32932891,Comparison between Conventional Blind Injections and Ultrasound-Guided Injections of Botulinum Toxin Type A into the Masseter: A Clinical Trial.,"The aim of the study was to propose a more efficient and safer botulinum toxin type A (BoNT-A) injection method for the masseter by comparing the conventional blind injection and a novel ultrasonography (US)-guided injection technique in a clinical trial. The 40 masseters from 20 healthy young Korean volunteers (10 males and 10 females with a mean age of 25.6 years) were included in this prospective clinical trial. The BoNT-A (24 U) was injected into the masseter of each volunteer using the conventional blind and US-guided injection techniques on the left and right sides, respectively, and analyzed by US and three-dimensional (3D) facial scanning. One case of PMB (paradoxical masseteric bulging) was observed on the side where a conventional blind injection was performed, which disappeared after the compensational injection. The reduction in the thickness of the masseter in the resting state differed significantly at 1 month after the injection between the conventional blind injection group and the US-guided injection group by 12.38 ± 7.59% and 17.98 ± 9.65%, respectively ( t (19) = 3.059,  p  = 0.007). The reduction in the facial contour also differed significantly at 1 month after the injection between the conventional blind injection group and the US-guided injection group by 1.95 ± 0.74 mm and 2.22 ± 0.84 mm, respectively ( t (19) = 2.908,  p  = 0.009). The results of the study showed that the US-guided injection method that considers the deep inferior tendon by visualizing the masseter can prevent the PMB that can occur during a blind injection, and is also more effective.",2020,"The reduction in the facial contour also differed significantly at 1 month after the injection between the conventional blind injection group and the US-guided injection group by 1.95 ± 0.74 mm and 2.22 ± 0.84 mm, respectively ( t (19) =","['20 healthy young Korean volunteers (10 males and 10 females with a mean age of 25.6 years', 'Masseter']","['novel ultrasonography (US)-guided injection technique', 'botulinum toxin type A (BoNT-A) injection method', 'Botulinum Toxin Type']",['facial contour'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0456651', 'cui_str': 'Method of injection'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}]",20.0,0.0380531,"The reduction in the facial contour also differed significantly at 1 month after the injection between the conventional blind injection group and the US-guided injection group by 1.95 ± 0.74 mm and 2.22 ± 0.84 mm, respectively ( t (19) =","[{'ForeName': 'Hyungkyu', 'Initials': 'H', 'LastName': 'Bae', 'Affiliation': 'Division in Anatomy and Developmental Biology, Department of Oral Biology, Human Identification Research Institute, BK21 PLUS Project, Yonsei University College of Dentistry, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Jisoo', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Youth Clinic, 30 Apgujeong-ro 80-gil, Gangnam-gu, Seoul 03722, Korea.'}, {'ForeName': 'Kyle K', 'Initials': 'KK', 'LastName': 'Seo', 'Affiliation': 'Modelo Clinic, 21 Apgujeong-ro 60-gil, Gangnam-gu, Seoul 03722, Korea.'}, {'ForeName': 'Kyung-Seok', 'Initials': 'KS', 'LastName': 'Hu', 'Affiliation': 'Division in Anatomy and Developmental Biology, Department of Oral Biology, Human Identification Research Institute, BK21 PLUS Project, Yonsei University College of Dentistry, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Seong-Taek', 'Initials': 'ST', 'LastName': 'Kim', 'Affiliation': 'Department of Orofacial Pain and Oral Medicine, Yonsei University College of Dentistry, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Hee-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Division in Anatomy and Developmental Biology, Department of Oral Biology, Human Identification Research Institute, BK21 PLUS Project, Yonsei University College of Dentistry, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}]",Toxins,['10.3390/toxins12090588']
1698,32932997,Virtual Reality-Based Cognitive-Motor Rehabilitation in Older Adults with Mild Cognitive Impairment: A Randomized Controlled Study on Motivation and Cognitive Function.,"The purpose of this study was to investigate the effects of virtual reality-based cognitive-motor rehabilitation (VRCMR) on the rehabilitation motivation and cognitive function in older adults. This study enrolled 40 older adults with mild cognitive impairment (MCI), living in the community. The subjects were randomly assigned to a VRCMR group ( n  = 20) or a conventional cognitive rehabilitation (CCR) group ( n  = 20). The VRCMR group underwent VRCMR using MOTOcog, a computer recognition program, whereas the CCR group underwent conventional cognitive rehabilitation, which included puzzles, wood blocks, card play, stick construction activity, and maze activity. Both interventions were performed 30 min per day, 5 days/week, for 6 weeks. This study performed a cognitive assessment using the Montreal Cognitive Assessment (MoCA) scale, Trail Making Test A and B (TMT-A/B), and Digit Span Test forward and backward (DST-forward/backward). In addition, a 0-to-10 numeric rating self-report scale was used to assess interest and motivation during the rehabilitation training. After the intervention, the VRCMR group showed a significantly greater improvement in the MoCA ( p  = 0.045), TMT-A ( p  = 0.039), TMT-B ( p  = 0.040), and DST-forward ( p  = 0.011) scores compared to the CCR group, but not in the DST-backward score ( p  = 0.424). In addition, subjects in the experimental group had significantly higher interest ( p  = 0.03) and motivation ( p  = 0.03) than those in the control group. Cohen's d effect size was 0.4, 0.3, 0.35, 0.4, and 0.5 for the MoCA, TMT-A, TMT-B, DST-forward, and DST-backward tests, respectively. This study demonstrates that VRCMR enhances motivation for rehabilitation and cognitive function in older adults with MCI better than CCR.",2020,"In addition, subjects in the experimental group had significantly higher interest ( p  = 0.03) and motivation ( p  = 0.03) than those in the control group.","['older adults', '40 older adults with mild cognitive impairment (MCI), living in the community', 'older adults with MCI better than CCR', 'Older Adults with Mild Cognitive Impairment']","['VRCMR', 'Virtual Reality-Based Cognitive-Motor Rehabilitation', 'conventional cognitive rehabilitation (CCR', 'virtual reality-based cognitive-motor rehabilitation (VRCMR']","['MoCA', 'Motivation and Cognitive Function', 'motivation', 'Montreal Cognitive Assessment (MoCA) scale, Trail Making Test A and B (TMT-A/B), and Digit Span Test forward and backward (DST-forward/backward']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1955905', 'cui_str': 'CCR Receptors'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C1955905', 'cui_str': 'CCR Receptors'}]","[{'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0262967', 'cui_str': 'Dihydrostreptomycin'}]",40.0,0.0188254,"In addition, subjects in the experimental group had significantly higher interest ( p  = 0.03) and motivation ( p  = 0.03) than those in the control group.","[{'ForeName': 'Ji-Su', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly, Industry, Dongseo University, Busan 47011, Korea.'}, {'ForeName': 'Young-Jin', 'Initials': 'YJ', 'LastName': 'Jung', 'Affiliation': 'Department of Radiological Science at Health Sciences Division in DongSeo University, Busan 47011, Korea.'}, {'ForeName': 'Gihyoun', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135701, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8030335']
1699,32933153,Krill Oil Has Different Effects on the Plasma Lipidome Compared with Fish Oil Following 30 Days of Supplementation in Healthy Women: A Randomized Controlled and Crossover Study.,"This is a follow-up of our previous postprandial study and it focused on the plasma lipidomic responses to 30 days of krill oil (KO) versus fish oil (FO) supplementations in healthy women. Eleven women (aged 18-50 years) consumed KO or FO for 30 days in a randomized, cross-over study, with at least a four-week washout period between supplementations. The daily supplements provided 1.27 g/day of long-chain (LC) omega-3 polyunsaturated fatty acids (PUFA) from KO (containing 0.76 g eicosapentaenoic acid (EPA), 0.42 g docosahexaenoic acid (DHA)) and 1.44 g/day from FO (containing 0.79 g EPA, 0.47 g DHA). Fasting plasma samples at days 0, 15, and 30 were analyzed using gas chromatography and liquid chromatography electrospray ionisation-tandem mass spectrometry. KO resulted in a significantly greater relative area under the curve (relAUC) for plasma EPA after 30 days. Lipidomic analysis showed that 26 of 43 lipid molecular species had a significantly greater relAUC in the KO group, while 17/43 showed a significantly lower relAUC compared with the FO group. More than 38% of the lipids species which increased more following KO contained omega-3 PUFA, while where FO was greater than KO, only 12% contained omega-3 PUFA. These data show that KO and FO do not have equivalent effects on the plasma lipidome.",2020,KO resulted in a significantly greater relative area under the curve (relAUC) for plasma EPA after 30 days.,"['Eleven women (aged 18-50 years', 'healthy women', 'Healthy Women']","['long-chain (LC) omega-3 polyunsaturated fatty acids (PUFA) from KO (containing 0.76 g eicosapentaenoic acid (EPA), 0.42 g docosahexaenoic acid (DHA', 'Krill Oil', 'consumed KO or FO', 'krill oil (KO) versus fish oil (FO) supplementations', 'Fish Oil']","['relative area under the curve (relAUC) for plasma EPA', 'Fasting plasma samples', 'relAUC', 'Plasma Lipidome']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C2725341', 'cui_str': 'krill oil'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C4517458', 'cui_str': '0.42'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C4727084', 'cui_str': 'Lipidome'}]",,0.0997975,KO resulted in a significantly greater relative area under the curve (relAUC) for plasma EPA after 30 days.,"[{'ForeName': 'Hyunsin H', 'Initials': 'HH', 'LastName': 'Sung', 'Affiliation': 'Institute for Health and Sport, Victoria University, P.O. Box 14428, Melbourne, VIC 8001, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Sinclair', 'Affiliation': 'Faculty of Health, Deakin University, Geelong, VIC 3217, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Huynh', 'Affiliation': 'Metabolomics Laboratory, Baker Heart and Diabetes Institute, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Adam A T', 'Initials': 'AAT', 'LastName': 'Smith', 'Affiliation': 'Metabolomics Laboratory, Baker Heart and Diabetes Institute, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Natalie A', 'Initials': 'NA', 'LastName': 'Mellett', 'Affiliation': 'Metabolomics Laboratory, Baker Heart and Diabetes Institute, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Meikle', 'Affiliation': 'Metabolomics Laboratory, Baker Heart and Diabetes Institute, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Xiao Q', 'Initials': 'XQ', 'LastName': 'Su', 'Affiliation': 'Institute for Health and Sport, Victoria University, P.O. Box 14428, Melbourne, VIC 8001, Australia.'}]",Nutrients,['10.3390/nu12092804']
1700,32933561,"Effects of yoga, aerobic, and stretching and toning exercises on cognition in adult cancer survivors: protocol of the STAY Fit pilot randomized controlled trial.","BACKGROUND


Cancer survivors experience compromised quality of life due to impaired cognitive function as a result of cancer diagnosis and treatment. Although exercise has proven to be effective in improving cognitive function across the lifespan, interventions comprehensively testing the effectiveness for cancer survivors are limited. The STAY Fit Trial is a three-armed pilot randomized controlled trial designed to compare the effects of a 12-week yoga, aerobic walking, and stretch and tone intervention on cognitive function among adult cancer survivors.
METHODS


This pilot study aims to recruit 75 adult cancer survivors who will complete assessments of cognitive function, cardiovascular fitness, physical activity, and psychosocial measures at baseline and after the 12-week intervention. The aims of STAY Fit are (1) to assess the efficacy of yoga to improve cognitive function among cancer survivors, compared to aerobic exercise and an active control group; (2) to examine changes in cardiovascular fitness as a result of the interventions; and (3) to assess changes in quality of life among our population as a result of the exercise interventions.
DISCUSSION


The STAY Fit Trial will test the effectiveness of yoga, aerobic exercise, and stretching and toning exercises in improving cognitive function and fitness among adult cancer survivors. The results of this pilot study will enable us to understand the most effective physical activity modality to improve cognitive function in this population and potentially combat cancer-related cognitive impairment.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03650322 . Registered on 28 August 2018.",2020,"The aims of STAY Fit are (1) to assess the efficacy of yoga to improve cognitive function among cancer survivors, compared to aerobic exercise and an active control group; (2) to examine changes in cardiovascular fitness as a result of the interventions; and (3) to assess changes in quality of life among our population as a result of the exercise interventions.
","['adult cancer survivors', 'cancer survivors', '75 adult cancer survivors']","['yoga, aerobic walking, and stretch and tone intervention', 'aerobic exercise', 'yoga, aerobic exercise, and stretching and toning exercises', 'yoga, aerobic, and stretching and toning exercises']","['cognitive function, cardiovascular fitness, physical activity, and psychosocial measures', 'quality of life', 'cardiovascular fitness', 'cognitive function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",75.0,0.0866846,"The aims of STAY Fit are (1) to assess the efficacy of yoga to improve cognitive function among cancer survivors, compared to aerobic exercise and an active control group; (2) to examine changes in cardiovascular fitness as a result of the interventions; and (3) to assess changes in quality of life among our population as a result of the exercise interventions.
","[{'ForeName': 'Neha P', 'Initials': 'NP', 'LastName': 'Gothe', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, 61801, USA. npg@illinois.edu.'}, {'ForeName': 'Emily D', 'Initials': 'ED', 'LastName': 'Erlenbach', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, 61801, USA.'}, {'ForeName': 'Samuel L', 'Initials': 'SL', 'LastName': 'Streeter', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, 61801, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Lehovec', 'Affiliation': 'Department of Dance, University of Illinois at Urbana-Champaign, Urbana, 61801, USA.'}]",Trials,['10.1186/s13063-020-04723-2']
1701,32934794,Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial.,"Background:  Delirium is a common and serious complication of major surgery for older adults. Postoperative social and behavioral support (e.g., early mobilization, mealtime assistance) may reduce the incidence and impact of delirium, and these efforts are possible with proactive patient-care programs. This pilot trial tests the hypothesis that a multicomponent decision support system, which sends automated alerts and recommendations to patient-care programs and family members for high-risk patients, will improve the postoperative environment for neurocognitive and clinical recovery.  Methods:  This will be a randomized, controlled, factorial pilot trial at a large academic medical center. High-risk, non-cardiac surgery patients (≥70 years old) will be recruited. Patients will be allocated to a usual care group (n=15), Hospital Elder Life Program (HELP)-based paging system (n=15), family-based paging system (n=15), or combined HELP- and family-based system (n=15). The primary outcome will be the presence of delirium, defined by positive long-form Confusion Assessment Method screening. Secondary outcomes will include additional HELP- and family-based performance metrics along with various neurocognitive and clinical recovery measures. Exploratory outcomes include the incidence of positive family-based delirium assessments post-discharge, 36-item Short Form Survey, PROMIS Cognitive Function Abilities Subset 4a, and 30-day readmission rates.  Ethics and dissemination:  This trial has received approval by the University of Michigan Medical Institutional Review Board (IRBMED). Dissemination plans include presentation at scientific conferences, publication in medical journals, and distribution via educational and news media.  Registration:  ClinicalTrials.gov Identifier NCT04007523, registered on 7/3/2019.",2019,"This pilot trial tests the hypothesis that a multicomponent decision support system, which sends automated alerts and recommendations to patient-care programs and family members for high-risk patients, will improve the postoperative environment for neurocognitive and clinical recovery.  ","['older adults', 'patient-care programs and family members for high-risk patients', 'High-risk, non-cardiac surgery patients (≥70 years old']","['usual care group (n=15), Hospital Elder Life Program (HELP)-based paging system (n=15), family-based paging system (n=15), or combined HELP- and family-based system']","['incidence of positive family-based delirium assessments post-discharge, 36-item Short Form Survey, PROMIS Cognitive Function Abilities Subset 4a, and 30-day readmission rates', 'presence of delirium, defined by positive long-form Confusion Assessment Method screening', 'additional HELP- and family-based performance metrics along with various neurocognitive and clinical recovery measures']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3874055', 'cui_str': 'Paging system'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.190457,"This pilot trial tests the hypothesis that a multicomponent decision support system, which sends automated alerts and recommendations to patient-care programs and family members for high-risk patients, will improve the postoperative environment for neurocognitive and clinical recovery.  ","[{'ForeName': 'Phillip E', 'Initials': 'PE', 'LastName': 'Vlisides', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Jacqueline W', 'Initials': 'JW', 'LastName': 'Ragheb', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Aleda', 'Initials': 'A', 'LastName': 'Leis', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Schoettinger', 'Affiliation': 'Department of Social Work, Michigan Medicine, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hickey', 'Affiliation': 'University of Michigan School of Nursing, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'McKinney', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Brooks', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Zierau', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Norcott', 'Affiliation': 'Department of Internal Medicine, Division of Geriatric and Palliative Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Avidan', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St. Louis, MO, 63110, USA.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Min', 'Affiliation': 'Department of Internal Medicine, Division of Geriatric and Palliative Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.'}]",F1000Research,['10.12688/f1000research.20597.2']
1702,32935866,"The reduction impact of monoglucosyl rutin on abdominal visceral fat: A randomized, placebo-controlled, double-blind, parallel-group.","Water soluble α-glycosylated rutin (4G-α-D-glucopyranosyl rutin, monoglucosyl rutin, MR) was used in this study to evaluate its ability to reduce abdominal visceral fat (AVF). We conducted a study examining 66 healthy Japanese men and women with a body mass index of ≥23 and <30 kg/m 2   for 8 weeks. The subjects were randomly assigned to groups via computer random numbers as follows: MR200 group (MR 200 mg/day), MR400 group (MR 400mg/day), or placebo group. The primary outcome was change in the AVF area after 8 weeks of intervention. The secondary outcomes were effects of MR on total fat and subcutaneous fat of umbilical area, lipid-related markers, and subjective symptoms. The per-protocol set analysis involved 18 subjects in the placebo group (7 males and 11 females), 20 subjects in the MR200 group (8 males and 12 females), and 20 subjects in the MR400 group (8 males and 12 females). AVF area in both the MR200 and MR400 groups was reduced at week 8, with changes from the baseline (week 0) significantly higher than the placebo group. Additionally, the MR400 group reported improved subjective symptoms concerning being ""worried about abdominal fat"" at week 4 compared with the placebo group. These results indicate that the consumption of MR (200 and 400 mg/day) for 8 weeks reduced AVF. PRACTICAL APPLICATION: Monoglucosyl rutin, an enzymatically modified form of rutin, is a highly stable and water-soluble flavonoid widely used in food and beverages to prevent oxidation. The present clinical study demonstrated that it may improve overall health by reducing abdominal visceral fat.",2020,"Additionally, the MR400 group reported improved subjective symptoms concerning being ""worried about abdominal fat"" at week 4 compared with the placebo group.","['18 subjects in the placebo group (7 males and 11 females), 20 subjects in the MR200 group (8 males and 12 females), and 20 subjects in the MR400 group (8 males and 12 females', '66 healthy Japanese men and women with a body mass index of ≥23 and <30\xa0kg/m 2\xa0  for 8 weeks']","['MR200', 'Water soluble α-glycosylated rutin (4G-α-D-glucopyranosyl rutin, monoglucosyl rutin, MR', 'placebo', 'MR400', 'monoglucosyl rutin']","['abdominal visceral fat (AVF', 'total fat and subcutaneous fat of umbilical area, lipid-related markers, and subjective symptoms', 'subjective symptoms', 'AVF area', 'MR400', 'overall health']","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0035976', 'cui_str': 'Rutin'}, {'cui': 'C3884877', 'cui_str': 'monoglucosyl-rutin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",66.0,0.164754,"Additionally, the MR400 group reported improved subjective symptoms concerning being ""worried about abdominal fat"" at week 4 compared with the placebo group.","[{'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Hashizume', 'Affiliation': 'Toyo Sugar Refining Co., Ltd, Yoto Bldg., 18-20, Nihombashi-Koamicho, Chuo-ku, Tokyo, 103-0016, Japan.'}, {'ForeName': 'Mahamadou', 'Initials': 'M', 'LastName': 'Tandia', 'Affiliation': 'Toyo Sugar Refining Co., Ltd, Yoto Bldg., 18-20, Nihombashi-Koamicho, Chuo-ku, Tokyo, 103-0016, Japan.'}]",Journal of food science,['10.1111/1750-3841.15429']
1703,32937232,A randomised oral fluoride retention study comparing intra-oral kinetics of fluoride-containing dentifrices before and after dietary acid exposure.,"OBJECTIVE


This exploratory, randomised, single-blind, crossover, study evaluated fluoride and calcium ion concentrations and pH following use of one of two 1450 ppm fluoride (NaF), 5% w/w KNO 3  dentifrices: (1) test dentifrice (with cocamidopropyl betaine) with an orange juice (OJ) rinse; (2) test dentifrice with a deionized (DI) water rinse or (3) comparator dentifrice (with sodium lauryl sulphate and tetrasodium pyrophosphate) with an OJ rinse.
DESIGN


Eighteen participants used their assigned dentifrice, rinsed with DI water, then expectorate was collected. Sixty min post-brushing, participants rinsed with OJ or DI water then expectorate was collected. Saliva samples were collected pre-brushing and at 1, 5, 10, 15, 30 and 60 min post-brushing and following the 60 min OJ/DI water rinse. The pH of samples was taken.
RESULTS


Significant differences (p < 0.05) were found in salivary fluoride ion concentrations between test and comparator dentifrices at 30 and 60 min and following the 60 min OJ rinse, favouring the former. Significant differences were also found between test and comparator dentifrices for salivary calcium ion concentration at 1, 5 and 10 min (p < 0.0001), favouring the former, and between test or comparator + OJ rinse and test + water rinse (p < 0.005), favouring the latter. No pH differences were shown prior to OJ/water rinse. Products were generally well-tolerated.
CONCLUSIONS


Results confirmed that acid-labile fluoride is released from the oral cavity following a dietary acid challenge and showed that formulation excipients may impact on retention of such.",2020,"Significant differences were also found between test and comparator dentifrices for salivary calcium ion concentration at 1, 5 and 10 min (p < 0.0001), favouring the former, and between test or comparator + OJ rinse and test + water rinse (p < 0.005), favouring the latter.",[],"['fluoride-containing dentifrices', '1450 ppm fluoride (NaF), 5% w/w KNO 3  dentifrices: (1) test dentifrice (with cocamidopropyl betaine) with an orange juice (OJ) rinse; (2) test dentifrice with a deionized (DI) water rinse or (3) comparator dentifrice (with sodium lauryl sulphate and tetrasodium pyrophosphate) with an OJ rinse']","['tolerated', 'salivary fluoride ion concentrations', 'salivary calcium ion concentration']",[],"[{'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C1849409', 'cui_str': 'Retinal detachment and occipital encephalocele'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0173050', 'cui_str': 'cocamidopropyl betaine'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0074764', 'cui_str': 'Pyrophosphate sodium'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0596235', 'cui_str': 'Calcium ion'}]",,0.0288269,"Significant differences were also found between test and comparator dentifrices for salivary calcium ion concentration at 1, 5 and 10 min (p < 0.0001), favouring the former, and between test or comparator + OJ rinse and test + water rinse (p < 0.005), favouring the latter.","[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Burnett', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, KT13 0DE, UK. Electronic address: Gary.R.Burnett@gsk.com.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Nehme', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, KT13 0DE, UK. Electronic address: drmnehme@gmail.com.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Parkinson', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, KT13 0DE, UK. Electronic address: charles.x.parkinson@gsk.com.""}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Karwal', 'Affiliation': 'GSK Consumer Healthcare, One Horizon Center, Golf Course Road, DLF Phase 5, Gurgaon, 12202, India. Electronic address: ritukarwal0283@gmail.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Badrock', 'Affiliation': 'Intertek Clinical Research Services, Oaklands Office Park, Hooton Rd, Hooton, Cheshire, CH66 7NZ UK. Electronic address: thomas.badrock@intertek.com.'}, {'ForeName': 'Gavin Vaughan', 'Initials': 'GV', 'LastName': 'Thomas', 'Affiliation': 'Intertek Clinical Research Services, Oaklands Office Park, Hooton Rd, Hooton, Cheshire, CH66 7NZ UK. Electronic address: gavin.thomas@intertek.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hall', 'Affiliation': 'Intertek Clinical Research Services, Oaklands Office Park, Hooton Rd, Hooton, Cheshire, CH66 7NZ UK. Electronic address: peter.hall@intertek.com.'}]",Archives of oral biology,['10.1016/j.archoralbio.2020.104891']
1704,32949650,"Multimorbidity, glycaemic variability and time in target range in people with type 2 diabetes: A baseline analysis of the GP-OSMOTIC trial.","AIMS


To explore associations between multimorbidity condition counts (total; concordant (diabetes-related); discordant (unrelated to diabetes)) and glycaemia (HbA1c; glycaemic variability (GV); time in range (TIR)) using data from a randomised controlled trial examining effectiveness of continuous glucose monitoring (CGM) in people with type 2 diabetes (T2D).
METHODS


Cross-sectional study: 279 people with T2D using baseline data from the General Practice Optimising Structured MOnitoring To Improve Clinical outcomes (GP-OSMOTIC) trial from 25 general practices in Australia. Number of long-term conditions (LTCs) in addition to T2D used to quantify total/concordant/discordant multimorbidity counts. GV (measured by coefficient of variation (CV)) and TIR derived from CGM data. Multivariable linear regression models used to examine associations between multimorbidity counts, HbA1c (%), GV and TIR.
RESULTS


Mean (SD) age of participants 60.4 (9.9) years; 40.9% female. Multimorbidity was present in 89.2% of participants. Most prevalent comorbid LTCs: hypertension (57.4%), painful conditions (29.8%), coronary heart disease (22.6%) and depression (19.0%). No evidence of associations between multimorbidity counts, HbA1c, GV and TIR.
CONCLUSIONS


While multimorbidity was common in this T2D cohort, it was not associated with HbA1c, CV or TIR. Future studies should explore factors other than glycaemia that contribute to the increased mortality observed in those with multimorbidity and T2D.",2020,"No evidence of associations between multimorbidity counts, HbA1c, GV and TIR.
","['people with type 2 diabetes', 'Cross-sectional study: 279 people with T2D using baseline data from the General Practice Optimising Structured MOnitoring', 'Mean (SD) age of participants 60.4 (9.9) years; 40.9% female', '25 general practices in Australia', 'people with type 2 diabetes (T2D']",['continuous glucose monitoring (CGM'],"['Number of long-term conditions (LTCs', 'GV (measured by coefficient of variation (CV)) and TIR', 'coronary heart disease', 'multimorbidity counts, HbA1c, GV and TIR', 'glycaemia (HbA1c; glycaemic variability (GV); time in range (TIR', 'Multimorbidity', 'HbA1c, CV or TIR', 'Multimorbidity, glycaemic variability and time in target range', 'multimorbidity counts, HbA1c (%), GV and TIR', 'painful conditions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",279.0,0.207765,"No evidence of associations between multimorbidity counts, HbA1c, GV and TIR.
","[{'ForeName': 'Jason I', 'Initials': 'JI', 'LastName': 'Chiang', 'Affiliation': 'Department of General Practice, University of Melbourne, Australia. Electronic address: jason.chiang@unimelb.edu.au.'}, {'ForeName': 'Jo-Anne', 'Initials': 'JA', 'LastName': 'Manski-Nankervis', 'Affiliation': 'Department of General Practice, University of Melbourne, Australia.'}, {'ForeName': 'Sharmala', 'Initials': 'S', 'LastName': 'Thuraisingam', 'Affiliation': 'Department of General Practice, University of Melbourne, Australia.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Jenkins', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""O'Neal"", 'Affiliation': ""Department of Medicine, St Vincent's Hospital, University of Melbourne, Australia.""}, {'ForeName': 'Frances S', 'Initials': 'FS', 'LastName': 'Mair', 'Affiliation': 'General Practice and Primary Care, Institute of Health and Wellbeing, University of Glasgow, UK.'}, {'ForeName': 'Bhautesh Dinesh', 'Initials': 'BD', 'LastName': 'Jani', 'Affiliation': 'General Practice and Primary Care, Institute of Health and Wellbeing, University of Glasgow, UK.'}, {'ForeName': 'Barbara I', 'Initials': 'BI', 'LastName': 'Nicholl', 'Affiliation': 'General Practice and Primary Care, Institute of Health and Wellbeing, University of Glasgow, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Furler', 'Affiliation': 'Department of General Practice, University of Melbourne, Australia.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108451']
1705,32949673,Effects of Appetitive and Aversive Motivational States on Wanting and Liking of Interpersonal Touch.,"Social rewards represent a strong driving force behind decisions and behaviors. Previous research suggests that the processing of a reward depends on the initial state of the individual. However, empirical research in humans on the influence of motivational states on reward processing is scant, especially for rewards of social nature. In the present study, we aimed at investigating how aversive and appetitive motivation affects the processing of social rewards, such as interpersonal touch. Participants (n = 102) were assigned to an appetitive (positive) or aversive (negative) motivational state condition (via modified versions of the Trier Social Stress Test) or to a control condition. After the state induction, their (a) self-reports of wanting and liking, (b) effort, and (c) hedonic facial reactions during anticipation and consumption of interpersonal touch, were measured. Participants in the aversive group showed higher subjective wanting of interpersonal touch, but no changes in subjective liking, compared to the control group. The aversive group also showed stronger positive hedonic facial reactions during reward anticipation, reflecting stronger anticipatory pleasure. No significant effects were found for the appetitive group. The results indicate that, after being exposed to an aversive experience, the motivation to obtain interpersonal touch, as well as the associated anticipatory pleasure, increase, without a corresponding change in liking during or after its consumption. The findings point to differential state-dependent effects on the processing of social rewards, possibly due to the action of different neurobiological systems regulating reward anticipation and consumption.",2020,"Participants in the aversive group showed higher subjective wanting of interpersonal touch, but no changes in subjective liking, compared to the control group.",['Participants (n = 102'],"['appetitive and aversive motivational states', 'appetitive (positive) or aversive (negative) motivational state condition (via modified versions of the Trier Social Stress Test) or to a control condition']","['subjective liking', 'positive hedonic facial reactions', 'wanting and liking of interpersonal touch', 'subjective wanting of interpersonal touch']",[],"[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0152054', 'cui_str': 'Touch'}]",102.0,0.0154452,"Participants in the aversive group showed higher subjective wanting of interpersonal touch, but no changes in subjective liking, compared to the control group.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Massaccesi', 'Affiliation': 'Faculty of Psychology, Department of Clinical and Health Psychology, University of Vienna, Austria. Electronic address: claudia.massaccesi@univie.ac.at.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Korb', 'Affiliation': 'Faculty of Psychology, Department of Cognition, Emotion, and Methods in Psychology, University of Vienna, Austria; Faculty of Psychology, University of Essex, Colchester, UK.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Skoluda', 'Affiliation': 'Faculty of Psychology, Department of Clinical and Health Psychology, University of Vienna, Austria.'}, {'ForeName': 'Urs M', 'Initials': 'UM', 'LastName': 'Nater', 'Affiliation': 'Faculty of Psychology, Department of Clinical and Health Psychology, University of Vienna, Austria.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Silani', 'Affiliation': 'Faculty of Psychology, Department of Clinical and Health Psychology, University of Vienna, Austria. Electronic address: giorgia.silani@univie.ac.at.'}]",Neuroscience,['10.1016/j.neuroscience.2020.09.025']
1706,32949780,Induction of LTD-like corticospinal plasticity by low-frequency rTMS depends on pre-stimulus phase of sensorimotor μ-rhythm.,"BACKGROUND


Neural oscillations reflect rapidly changing brain excitability states. We have demonstrated previously with EEG-triggered transcranial magnetic stimulation (TMS) of human motor cortex that the positive vs. negative peak of the sensorimotor μ-oscillation reflect corticospinal low-vs. high-excitability states. In vitro experiments showed that induction of long-term depression (LTD) by low-frequency stimulation depends on the postsynaptic excitability state.
OBJECTIVE/HYPOTHESIS


We tested the hypothesis that induction of LTD-like corticospinal plasticity in humans by 1 Hz repetitive TMS (rTMS) is enhanced when rTMS is synchronized with the low-excitability state, but decreased or even shifted towards long-term (LTP)-like plasticity when synchronized with the high-excitability state.
METHODS


We applied real-time EEG-triggered 1-Hz-rTMS (900 pulses) to the hand area of motor cortex in healthy subjects. In a randomized double-blind three-condition crossover design, pulses were synchronized to either the positive or negative peak of the sensorimotor μ-oscillation, or were applied at random phase (control). The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
RESULTS


1-Hz-rTMS at random phase resulted in a trend towards LTD-like corticospinal plasticity. RTMS in the positive peak condition (i.e., the low-excitability state) induced significant LTD-like plasticity. RTMS in the negative peak condition (i.e., the high-excitability state) showed a trend towards LTP-like plasticity, which was significantly different from the other two conditions.
CONCLUSION


The level of corticospinal depolarization reflected by phase of the μ-oscillation determines the degree of corticospinal plasticity induced by low-frequency rTMS, a finding that may guide future personalized therapeutic stimulation.",2020,"The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
",['healthy subjects'],"['Hz repetitive TMS (rTMS', '1-Hz-rTMS', 'EEG-triggered transcranial magnetic stimulation (TMS']","['amplitude of motor evoked potentials', 'induction of long-term depression (LTD']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}]","[{'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.095784,"The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baur', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Galevska', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, National Institutes of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Leonardo G', 'Initials': 'LG', 'LastName': 'Cohen', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, National Institutes of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Ziemann', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany. Electronic address: ulf.ziemann@uni-tuebingen.de.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Zrenner', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}]",Brain stimulation,['10.1016/j.brs.2020.09.005']
1707,32954762,The management of hemiplegic shoulder pain in stroke subjects undergoing pulsed radiofrequency treatment of the suprascapular and axillary nerves: a pilot study.,"BACKGROUND


Our trial aims to provide evidence for pain management and rehabilitation in patients with hemiplegic shoulder pain (HSP). HSP is one of the most common pains and disabilities occurring after a stroke. With accumulating evidence, the management of the suprascapular nerve (SSN) or axillary nerve (AN) might effectively relieve the pain and disability associated with HSP. However, no study has compared the effects of pulsed radiofrequency and nerve block of SSN and AN.
METHODS


Twenty patients with chronic stroke (over one year from onset) and HSP [visual analog scale (VAS) for pain ≥30 mm] randomly underwent ultrasound-guided SSN and AN pulsed radiofrequency or nerve block treatment. All patients were evaluated before treatment (T0) and at 4 (T1) and 16 (T2) weeks of follow-up. The primary outcome was the VAS score. Secondary outcomes were the Modified Ashworth Scale (MAS) score, passive shoulder range of motion (PROM), Disability Assessment Scale (DAS) score, and EuroQol-5 dimension questionnaire (EQ-5D).
RESULTS


Significant improvements in the VAS score were observed in both groups at T1 and T2. However, a significant difference was not observed between the two groups (T1: P=0.43; T2: P=0.23). No statistically significant differences were observed in the MAS score between the two groups at T1 (P=0.06) and T2 (P=0.07). In the PROM of shoulder abduction and external rotation, statistically, significant differences were observed between the two groups at T1 (P=0.02*, & P=0.04*) and T2 (P=0.02*, & P=0.00*). Statistically significant differences in shoulder flexion and extension were not observed between the two groups at T1 (P=0.23, & P=0.35) and T2 (P=0.14, & P=0.14). Statistically significant differences in the DAS score were not observed between the 2 groups at T1 (P=0.51, & P=0.33, & P=0.36, & P=0.75) and T2 (P=0.12, & P=0.54, & P=0.41, & P=0.86). No statistically significant differences in the EQ-5D responses were observed between the two groups at T1 (P=0.42) and T2 (P=0.11).
CONCLUSIONS


Pulsed radiofrequency of SSN and AN achieves similar therapeutic effects to the nerve block. Pulsed radiofrequency modulation is superior to nerve block in improving the PROM of shoulder abduction and external rotation.",2020,"In the PROM of shoulder abduction and external rotation, statistically, significant differences were observed between the two groups at T1 (P=0.02*, & P=0.04*) and T2 (P=0.02*, & P=0.00*).","['stroke subjects undergoing', 'patients with hemiplegic shoulder pain (HSP', 'Twenty patients with chronic stroke (over one year from onset) and HSP [visual analog scale (VAS) for pain ≥30 mm] randomly underwent']","['pulsed radiofrequency and nerve block of SSN', 'ultrasound-guided SSN and AN pulsed radiofrequency or nerve block treatment', 'HSP', 'Pulsed radiofrequency modulation', 'pulsed radiofrequency treatment of the suprascapular and axillary nerves']","['Modified Ashworth Scale (MAS) score, passive shoulder range of motion (PROM), Disability Assessment Scale (DAS) score, and EuroQol-5 dimension questionnaire (EQ-5D', 'EQ-5D responses', 'MAS score', 'DAS score', 'VAS score', 'hemiplegic shoulder pain', 'shoulder flexion and extension']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0228878', 'cui_str': 'Structure of suprascapular nerve'}, {'cui': 'C0228885', 'cui_str': 'Structure of axillary nerve'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]",20.0,0.0661042,"In the PROM of shoulder abduction and external rotation, statistically, significant differences were observed between the two groups at T1 (P=0.02*, & P=0.04*) and T2 (P=0.02*, & P=0.00*).","[{'ForeName': 'Congxian', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Analgesia Department of Shandong Provincial Hospital Affiliated to the Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Imaging Department of Shandong Provincial Hospital Affiliated to the Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Analgesia Department of Qingdao Municipal Hospital, Qingdao, China.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Yidu Central Hospital, Weifang, China.'}, {'ForeName': 'Shengtao', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Analgesia Department of Shandong Provincial Hospital Affiliated to the Shandong First Medical University, Jinan, China. wshengt@126.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1618']
1708,32926850,Effects of Hyperosmolar Dextrose Injection in Patients With Rotator Cuff Disease and Bursitis: A Randomized Controlled Trial.,"OBJECTIVE


To determine whether dextrose prolotherapy offers clinical benefits in patients with shoulder pain and bursitis.
DESIGN


Double-blinded, randomized controlled trial.
SETTING


Outpatient rehabilitation department of a single medical center.
PARTICIPANTS


Patients (N=50) who had received a diagnosis of shoulder pain and bursitis through clinical tests and ultrasound examination.
INTERVENTIONS


Participants were randomly assigned to the 15% dextrose injection (D15W) group or the placebo group to receive either D15W or normal saline injection, respectively. All participants received ultrasound-guidance bursal injection every 2 weeks for a total of 3 injections.
MAIN OUTCOME MEASURES


The primary outcome was maximal pain level while performing activities. The secondary outcomes included resting pain level, function and disability assessment results, and ultrasonographic parameters. Participants were followed up for 3 months after completion of the injection course.
RESULTS


No significant differences in baseline characteristics were observed between the D15W and placebo groups. Significant time effects were observed for all outcome parameters (all P<.05); however, time × group effects were nonsignificant for all outcomes, except for tissue elasticity (P=.026).
CONCLUSIONS


Supporting evidence is insufficient regarding the clinical benefits of 15% dextrose bursal injection administered through 3 sessions in patients with chronic shoulder pain and bursitis. The findings indicate that these injections may increase the tissue stiffness of the supraspinatus tendon, as indicated by elastography assessment results, but further research is required to determine the nature of such changes in elastography findings.",2020,"Significant time effects were observed for all outcome parameters (all P < .05); however, time × group effects were nonsignificant for all outcomes, except for tissue elasticity (P = .026).
","['patients with shoulder pain and bursitis', 'Fifty patients who had received a diagnosis of shoulder pain and bursitis through clinical tests and ultrasound examination', 'patients with rotator cuff disease and bursitis', 'patients with chronic shoulder pain and bursitis', 'Outpatient rehabilitation department of a single medical center']","['hyperosmolar dextrose injection', 'ultrasound-guidance bursal injection', 'placebo group to receive either 15% dextrose injection or normal saline injection', 'dextrose prolotherapy']","['baseline characteristics', 'tissue stiffness', 'tissue elasticity', 'resting pain level, function and disability assessment results, and ultrasonographic parameters', 'maximal pain level while performing activities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0006444', 'cui_str': 'Bursitis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0587478', 'cui_str': 'Rehabilitation department'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0500223', 'cui_str': 'Prolotherapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C1562328', 'cui_str': 'Tissue elasticity'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",50.0,0.64811,"Significant time effects were observed for all outcome parameters (all P < .05); however, time × group effects were nonsignificant for all outcomes, except for tissue elasticity (P = .026).
","[{'ForeName': 'Yu-Ju', 'Initials': 'YJ', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mackay Memorial Hospital, Mackay Medical College, Taipei.'}, {'ForeName': 'Feng-Hang', 'Initials': 'FH', 'LastName': 'Chang', 'Affiliation': 'Graduate Institute of Injury Prevention and Control, Taipei Medical University, Taipei; Department of Physical Medicine and Rehabilitation, School of Medicine, College of Medicine, Taipei Medical University, Taipei.'}, {'ForeName': 'Peng-Hsuan', 'Initials': 'PH', 'LastName': 'Hou', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mackay Memorial Hospital, Mackay Medical College, Taipei.'}, {'ForeName': 'Kai-Hsiang', 'Initials': 'KH', 'LastName': 'Tseng', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mackay Memorial Hospital, Mackay Medical College, Taipei.'}, {'ForeName': 'Yen-Nung', 'Initials': 'YN', 'LastName': 'Lin', 'Affiliation': 'Graduate Institute of Injury Prevention and Control, Taipei Medical University, Taipei; Department of Physical Medicine and Rehabilitation, Wan-Fang Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: semitune@gmail.com.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.08.010']
1709,32927476,A Human Randomized Controlled Trial Comparing Metabolic Responses to Single and Repeated Hypoglycemia in Type 1 Diabetes.,"AIMS


Hypoglycemia hinders optimal glycemic management in type 1 diabetes (T1D). Long diabetes duration and hypoglycemia impair hormonal counter-regulatory responses to hypoglycemia. Our study was designed to test whether (1) the metabolic responses and insulin sensitivity are impaired, and (2) whether they are affected by short-lived antecedent hypoglycemia in participants with T1D.
MATERIALS AND METHODS


In a randomized, crossover, 2x2 factorial design, 9 male participants with T1D and 9 comparable control participants underwent 30 minutes of hypoglycemia (p-glucose < 2.9 mmol/L) followed by a euglycemic clamp on 2 separate interventions: with and without 30 minutes of hypoglycemia the day before the study day.
RESULTS


During both interventions insulin sensitivity was consistently lower, while counter-regulatory hormones were reduced, with 75% lower glucagon and 50% lower epinephrine during hypoglycemia in participants with T1D, who also displayed 40% lower lactate and 5- to 10-fold increased ketone body concentrations following hypoglycemia, whereas palmitate and glucose turnover, forearm glucose uptake, and substrate oxidation did not differ between the groups. In participants with T1D, adipose tissue phosphatase and tensin homolog (PTEN) content, hormone-sensitive lipase (HSL) phosphorylation, and muscle glucose transporter type 4 (GLUT4) content were decreased compared with controls. And antecedent hypoglycemic episodes lasting 30 minutes did not affect counter-regulation or insulin sensitivity.
CONCLUSIONS


Participants with T1D displayed insulin resistance and impaired hormonal counter-regulation during hypoglycemia, whereas glucose and fatty acid fluxes were intact and ketogenic responses were amplified. We observed subtle alterations of intracellular signaling and no effect of short-lived antecedent hypoglycemia on subsequent counter-regulation. This plausibly reflects the presence of insulin resistance and implies that T1D is a condition with defective hormonal but preserved metabolic responsiveness to short-lived hypoglycemia.",2020,GLUT4 content were decreased compared with controls.,"['type 1 diabetes (T1D', 'nine male participants with T1D and nine comparable control participants underwent 30\xa0min hypoglycemia (p-glucose<2.9mmol/L) followed by a', 'type 1 diabetes']","['epinephrine', 'euglycemic clamp']","['ketone bodies concentrations', 'adipose tissue PTEN content, HSL phosphorylation and muscle', 'GLUT4 content', 'palmitate and glucose turnover, forearm glucose uptake and substrate oxidation', 'counterregulatory hormones', 'insulin sensitivity']","[{'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}]","[{'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C1430988', 'cui_str': 'PTEN protein, human'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",9.0,0.0812553,GLUT4 content were decreased compared with controls.,"[{'ForeName': 'Mads Bisgaard', 'Initials': 'MB', 'LastName': 'Bengtsen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Støy', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Nikolaj Fibiger', 'Initials': 'NF', 'LastName': 'Rittig', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Thomas Schmidt', 'Initials': 'TS', 'LastName': 'Voss', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Nils Erik', 'Initials': 'NE', 'LastName': 'Magnusson', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Mads Vadsted', 'Initials': 'MV', 'LastName': 'Svart', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jessen', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus N, Denmark.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa645']
1710,32927668,Cocoa-Rich Chocolate and Quality of Life in Postmenopausal Women: A Randomized Clinical Trial.,"Menopause has a negative impact on quality of life (QoL). The aim of the present study was to analyse the effect on QoL of adding 10 g per day of chocolate with a high concentration of cocoa (99%) to the habitual diet, for 6 months, in a sample of postmenopausal women. Postmenopausal women ( n  = 140) aged 50-64 years were randomised to either an addition of 10 g per day of cocoa-rich chocolate to their usual diet or no supplement addition. All variables were measured at baseline and after six months of intervention. QoL was evaluated using the 3-level version of EuroQol-5D (EuroQoL-5D-3L), the EuroQol Visual Analogue Scale (EQ-VAS) and the Cervantes scale. Analysis of covariance (ANCOVA) analyses adjusted for the main determinants of QoL considered in this study showed no changes in the global score of QoL evaluated with the EuroQoL-5D-3L. The intervention group showed an increase of 6.0 points (95% confidence interval (CI): 0.4, 11.7) in the EQ-VAS compared to the control group ( p  = 0.036). No significant changes were observed between groups in the global score of QoL nor in the dimensions and subdimensions measured with the Cervantes scale. The additional daily contribution of 10 g of cocoa-rich chocolate in postmenopausal women could have a slight impact on their perception toward their health state, although without modifying the health-related QoL or the dimensions that compose it.",2020,No significant changes were observed between groups in the global score of QoL nor in the dimensions and subdimensions measured with the Cervantes scale.,"['Postmenopausal Women', 'Postmenopausal women ( n  = 140) aged 50-64 years', 'postmenopausal women']","['cocoa-rich chocolate', 'Cocoa-Rich Chocolate', 'chocolate with a high concentration of cocoa (99%) to the habitual diet', 'cocoa-rich chocolate to their usual diet or no supplement addition']","['3-level version of EuroQol-5D (EuroQoL-5D-3L), the EuroQol Visual Analogue Scale (EQ-VAS) and the Cervantes scale', 'global score of QoL', 'quality of life (QoL']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",140.0,0.0901054,No significant changes were observed between groups in the global score of QoL nor in the dimensions and subdimensions measured with the Cervantes scale.,"[{'ForeName': 'Irene A', 'Initials': 'IA', 'LastName': 'Garcia-Yu', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Garcia-Ortiz', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Manuel A', 'Initials': 'MA', 'LastName': 'Gomez-Marcos', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Rodriguez-Sanchez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Olaya', 'Initials': 'O', 'LastName': 'Tamayo-Morales', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Maderuelo-Fernandez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Recio-Rodriguez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}]",Nutrients,['10.3390/nu12092754']
1711,32936085,User Experience and Effects of an Individually Tailored Transdiagnostic Internet-Based and Mobile-Supported Intervention for Anxiety Disorders: Mixed-Methods Study.,"BACKGROUND


Internet interventions have been shown to be effective in treating anxiety disorders. Most interventions to date focus on single disorders and disregard potential comorbidities.
OBJECTIVE


The aim of this mixed-methods study was to investigate feasibility, user experience, and effects of a newly developed individually tailored transdiagnostic guided internet intervention for anxiety disorders.
METHODS


This study is an uncontrolled, within-group, baseline, postintervention pilot trial with an embedded qualitative and quantitative process and effect evaluation. In total, 49 adults with anxiety disorders (generalized anxiety disorder n=20, social phobia n=19, agoraphobia without panic n=12, panic with agoraphobia n=6, panic without agoraphobia n=4, subclinical depression n=41) received access to the 7-session intervention. We examined motivation and expectations, intervention use, user experience, impact, and modification requests. Qualitative data were assessed using semistructured interviews and analyzed by qualitative content analysis. Quantitative outcomes included symptom severity of anxiety and depression (Hamilton Anxiety Rating Scale [HAM-A], Quick Item Inventory of Depressive Symptomatology clinician rating [QIDS-C]), diagnostic status in clinical interviews (Mini International Neuropsychiatric Interview [MINI]), and web-based self-reports (Generalized Anxiety Disorder-7 [GAD-7], Center for Epidemiological Studies Depression Scale [CES-D], Beck Anxiety Inventory [BAI], Panic and Agoraphobia Scale [PAS], Social Phobia Scale [SPS], Patient Health Questionnaire-9 [PHQ-9]) at baseline and postassessment. Quantitative data was analyzed by comparing within-group means expressed as Cohen d.
RESULTS


Anxiety symptom severity (HAM-A d=1.19) and depressive symptoms (QIDS-C d=0.42) improved significantly, and 54% (21/39) no longer were diagnosed as having any anxiety disorder. The main positive effects were the general improvement of disease burden and attentiveness to feelings and risk situations while the main negative effects experienced were lack of change in disease burden and symptom deterioration. The most prevalent reasons for participation were the advantages of online treatment, symptom burden, and openness toward online treatment. Helpful factors included support, psychoeducation and practicing strategies in daily life; the main hindering factors were too little individualization and being overwhelmed by the content and pace.
CONCLUSIONS


The intervention was found to be feasible and results show preliminary data indicating potential efficacy for improving anxiety and depression. The next step should be the evaluation within a randomized controlled trial. Concerning intervention development, it was found that future interventions should emphasize individualization even more in order to further improve the fit to individual characteristics, preferences, and needs.",2020,"RESULTS


Anxiety symptom severity (HAM-A d=1.19) and depressive symptoms (QIDS-C d=0.42) improved significantly, and 54% (21/39) no longer were diagnosed as having any anxiety disorder.","['49 adults with anxiety disorders (generalized anxiety disorder n=20, social phobia n=19, agoraphobia without panic n=12, panic with agoraphobia n=6, panic without agoraphobia n=4, subclinical depression n=41) received']","['access to the 7-session intervention', 'Individually Tailored Transdiagnostic Internet-Based and Mobile-Supported Intervention']","['Anxiety symptom severity (HAM-A d=1.19) and depressive symptoms', 'symptom severity of anxiety and depression (Hamilton Anxiety Rating Scale [HAM-A], Quick Item Inventory of Depressive Symptomatology clinician rating [QIDS-C]), diagnostic status in clinical interviews (Mini International Neuropsychiatric Interview [MINI]), and web-based self-reports (Generalized Anxiety Disorder-7 [GAD-7], Center for Epidemiological Studies Depression Scale [CES-D], Beck Anxiety Inventory [BAI], Panic and Agoraphobia Scale [PAS], Social Phobia Scale [SPS], Patient Health Questionnaire-9', 'disease burden and attentiveness to feelings and risk situations', 'disease burden and symptom deterioration', 'anxiety and depression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0233413', 'cui_str': 'Attentiveness'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",49.0,0.0454209,"RESULTS


Anxiety symptom severity (HAM-A d=1.19) and depressive symptoms (QIDS-C d=0.42) improved significantly, and 54% (21/39) no longer were diagnosed as having any anxiety disorder.","[{'ForeName': 'Kiona K', 'Initials': 'KK', 'LastName': 'Weisel', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Anna-Carlotta', 'Initials': 'AC', 'LastName': 'Zarski', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Krieger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Moser', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Schaub', 'Affiliation': 'Swiss Research Institute of Public Health and Addiction ISGF, Associated to the University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Görlich', 'Affiliation': 'Institute of Biostatistics and Clinical Research, Westfälische Wilhelms-Universität Münster, Münster, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Berking', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Clinical, Neuro- & Development Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/16450']
1712,32936087,Mobile Breast Cancer e-Support Program for Chinese Women With Breast Cancer Undergoing Chemotherapy (Part 3): Secondary Data Analysis.,"BACKGROUND


Many app-based interventions targeting women with breast cancer have been developed and tested for effectiveness. However, information regarding the evaluation of the usage of these interventions is scarce. A better understanding of usage data is important to determine how women use apps and how these interventions affect health outcomes.
OBJECTIVE


This study aimed to examine the usage duration and login frequency of an app-based intervention, the Breast Cancer e-Support (BCS) program, and to investigate the association between usage data and participants' demographic and medical characteristics.
METHODS


This study is a secondary data analysis of a randomized controlled trial assessing the effectiveness of the BCS program. The BCS program contains four modules: Learning Forum, Discussion Forum, Ask-the-Expert Forum, and Your Story Forum. A total of 57 women in the intervention group accessed the BCS program during their 12-week chemotherapy. The app's background system tracked the usage duration and login frequency for each forum and the entire BCS program.
RESULTS


The total usage duration per participant ranged from 0 to 9371 minutes, and the login frequency per participant ranged from 0 to 774 times. The Discussion Forum and the Learning Forum were the most frequently used modules. The general linear model showed that age, education, family monthly income, and employment were associated with BCS usage duration and/or login frequency. Age (F 1,45 =10.09, P=.003, B=115.34, 95% CI 42.22-188.47) and education level (F 1,45 =7.22, P=.01, B=1949.63, 95% CI 487.76-3411.50) were positively associated with the usage duration of the entire BCS program. Family monthly income was positively associated with the usage duration of the Learning Forum (F 1,45 =11.85, P=.001, B=1488.55, 95% CI 617.58-2359.51) and the login frequency of the entire BCS program (F 1,45 =4.47, P=.04, B=113.68, 95% CI 5.33-222.03). Employment was negatively associated with the usage duration of the Ask-the-expert Forum (F 1,45 =4.50, P=.04, B=-971.87, 95% CI -1894.66 to -49.07) and the Your Story Forum (F 1,45 =5.36, P=.03, B=-640.71, 95% CI -1198.30 to -83.11) and positively associated with the login frequency of the entire BCS program (F 1,45 =10.86, P=.002, B=192.88, 95% CI 75.01-310.74). No statistical differences were found between BCS usage data and cancer stage, BMI, comorbidity, types of surgery, or cycles of chemotherapy.
CONCLUSIONS


Overall, this study found considerable variability in the usage of app-based interventions. When health care professionals incorporate app-based interventions into their routine care for women with breast cancer, the learning and discussion functions of apps should be strengthened to promote engagement. Additionally, characteristics of women with breast cancer, such as age, level of education, income, and employment status, should be taken in consideration to develop tailored apps that address their particular needs and therefore improve their engagement with the app.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12616000639426; http://www.ANZCTR.org.au/ACTRN12616000639426.aspx.",2020,"Age (F 1,45 =10.09, P=.003, B=115.34","['Chinese Women', 'women with breast cancer', 'With Breast Cancer Undergoing Chemotherapy (Part 3', '57 women in the intervention group accessed the BCS program during their 12-week chemotherapy']","['Mobile Breast Cancer e-Support Program', 'app-based intervention, the Breast Cancer e-Support (BCS) program']","['education level', 'Your Story Forum', 'usage duration of the Ask-the-expert Forum', 'BCS usage data and cancer stage, BMI, comorbidity, types of surgery, or cycles of chemotherapy', 'usage duration of the Learning Forum', 'login frequency of the entire BCS program']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0027646', 'cui_str': 'Cancer staging'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1268990', 'cui_str': 'Entire breast'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",57.0,0.0397284,"Age (F 1,45 =10.09, P=.003, B=115.34","[{'ForeName': 'Haihua', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Nursing Department, First Affiliated Hospital, Xiamen University, Xiamen, China.'}, {'ForeName': 'Xiuwan', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Nursing Department, First Affiliated Hospital, Xiamen University, Xiamen, China.'}, {'ForeName': 'Jinqiu', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Nursing, School of Medicine, Xiamen University, Xiamen, China.'}, {'ForeName': 'Qiaoling', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Hospital Infection Management Office, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jiemin', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Nursing, School of Medicine, Xiamen University, Xiamen, China.'}, {'ForeName': 'Sally Wai-Chi', 'Initials': 'SW', 'LastName': 'Chan', 'Affiliation': 'Global Engagement and Partnership Division, UON Singapore campus, University of Newcastle, Newcastle, Australia.'}]",JMIR mHealth and uHealth,['10.2196/18896']
1713,32931949,A randomized controlled trial of NSAIDs or exercise to reduce delayed local pain after influenza vaccination.,,2020,,[],['NSAIDS or Exercise'],['Delayed Local Pain'],[],"[{'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.334827,,"[{'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Housel', 'Affiliation': 'Defense Health Agency, Immunization Healthcare Division, South Atlantic Region Vaccine Safety Hub, Fort Bragg, NC; Department of Medicine, Womack Army Medical Center, Fort Bragg, NC. Electronic address: Laurie.a.housel.civ@mail.mil.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Beltran', 'Affiliation': 'Department of Research, Womack Army Medical Center, Fort Bragg, NC.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Spooner', 'Affiliation': 'Defense Health Agency, Immunization Healthcare Division, Public Health Division, Fort Bragg, NC.'}, {'ForeName': 'Limone C', 'Initials': 'LC', 'LastName': 'Collins', 'Affiliation': 'Defense Health Agency, Immunization Healthcare Division, Public Health Division, Fort Bragg, NC; Department of Medicine, Walter Reed National Military Medical Center, Bethesda, Md.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Ewing', 'Affiliation': 'Viral and Rickettsial Diseases Department, Naval Medical Research Center, Silver Spring, Md.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Viral and Rickettsial Diseases Department, Naval Medical Research Center, Silver Spring, Md.'}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'McClenathan', 'Affiliation': 'Defense Health Agency, Immunization Healthcare Division, South Atlantic Region Vaccine Safety Hub, Fort Bragg, NC; Department of Medicine, Womack Army Medical Center, Fort Bragg, NC.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.08.058']
1714,32932051,Measuring upper limb disability for patients with neck pain: Evaluation of the feasibility of the single arm military press (SAMP) test.,"BACKGROUND


Non-specific neck pain (NSNP) is frequently associated with upper limb disability (ULD). Consequently, evaluation of ULD using an outcome measure is necessary during the management of patients with NSNP. The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain. During the SAMP test, patients are asked to repeatedly lift a weight above their head for 30 s. The number of repetitions is counted. Its clinical utility in a patient group is still unknown.
OBJECTIVE


This study investigates the feasibility of the SAMP test from patients and clinicians' perspectives.
METHODS


Seventy female patients with NSNP were randomly allocated into one of three groups. Participants in each group completed the SAMP test using one of three proposed weights (½kg, 1 kg or 1½kg). The feasibility of the SAMP test was established using structured qualitative exit feedback interviews for patients and administrating clinicians.
RESULTS


Participants using ½kg achieved the highest number of repetitions, but a high proportion reported the weight as extremely light, whereas those who tested using the 1½kg achieved the lowest number of repetitions and participants reported the weight as being heavy. Participants tested using 1 kg achieved an average number of repetitions and a high proportion reported the weight as acceptably heavy. Clinicians and patients reported that the SAMP test was efficient and convenient.
CONCLUSION


The 1 kg SAMP test is feasible for use in female patients with NSNP. The measurement properties of the SAMP test should be determined in a patient group.",2020,The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain.,"[""patients and clinicians' perspectives"", 'patients and administrating clinicians', 'Seventy female patients with NSNP', 'female patients with NSNP', 'patients with NSNP', 'populations with neck pain', 'patients with neck pain']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],[],70.0,0.0379593,The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain.,"[{'ForeName': 'Ahmad Salah Eldin', 'Initials': 'ASE', 'LastName': 'Alreni', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: Ahmad.Alreni@uantwerpen.be.'}, {'ForeName': 'Heba Roohy', 'Initials': 'HR', 'LastName': 'Abdo Aboalmaty', 'Affiliation': 'Department of Sports Training and Kinesiology, Tanta University El-Gaish Street, Tanta Qism 2, Tanta, Garbia Government, Egypt. Electronic address: hebaabdoaboalmaty@outlook.com.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'De Hertogh', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: willem.dehertogh@uantwerpen.be.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Meirte', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: jill.meirte@uantwerpen.be.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Harrop', 'Affiliation': 'Centre for Health and Social Care Research, Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, United Kingdom. Electronic address: D.Harrop@shu.ac.uk.'}, {'ForeName': 'Sionnadh Mairi', 'Initials': 'SM', 'LastName': 'McLean', 'Affiliation': 'Centre for Health and Social Care Research, Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, United Kingdom. Electronic address: s.mclean@shu.ac.uk.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102254']
1715,32933009,Modifications of Gut Microbiota after Grape Pomace Supplementation in Subjects at Cardiometabolic Risk: A Randomized Cross-Over Controlled Clinical Trial.,"Polyphenols are dietary bioactive compounds able to induce modifications in the gut microbiota profile, although more clinical studies are needed. With this aim, a randomized cross-over clinical trial was conducted, where 49 subjects at cardiometabolic risk (exhibiting at least two metabolic syndrome factors) were supplemented with a daily dose of 8 g of grape pomace (GP) for 6 weeks, with an equivalent control (CTL) period. The levels of total bacteria and Bacteroidetes, Firmicutes, Lactobacilliales,  Bacteroides  and  Prevotella  were estimated in fecal DNA by quantitative real-time PCR (qPCR), while fecal short-chain fatty acids (SCFAs) were assessed by gas chromatography. Several cardiometabolic markers were evaluated in blood samples. GP reduced insulin levels only in half of the participants (responders). GP supplementation did not cause significant modifications in the microbiota profile of the whole group, except for a tendency ( p  = 0.059) towards a decrease in the proportion of Lactobacilliales, while it increased the proportion of  Bacteroides  in non-responder subjects. The reduction of insulin levels in subjects at cardiometabolic risk upon GP supplementation appears not to be induced by changes in the major subgroups of gut microbiota. Further studies at the species level may help to elucidate the possible role of microbiota in GP-induced insulinemic status.",2020,"GP supplementation did not cause significant modifications in the microbiota profile of the whole group, except for a tendency ( p  = 0.059) towards a decrease in the proportion of Lactobacilliales, while it increased the proportion of  Bacteroides  in non-responder subjects.","['subjects at cardiometabolic risk upon', '49 subjects at cardiometabolic risk (exhibiting at least two metabolic syndrome factors', 'Subjects at Cardiometabolic Risk']","['GP supplementation', 'Gut Microbiota after Grape Pomace Supplementation']","['GP reduced insulin levels', 'levels of total bacteria and Bacteroidetes, Firmicutes, Lactobacilliales,  Bacteroides  and  Prevotella  were estimated in fecal DNA by quantitative real-time PCR (qPCR), while fecal short-chain fatty acids (SCFAs', 'microbiota profile', 'proportion of Lactobacilliales', 'insulin levels']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0018208', 'cui_str': 'Grapes'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]","[{'cui': 'C0018208', 'cui_str': 'Grapes'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0242946', 'cui_str': 'Prevotella'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",,0.0244715,"GP supplementation did not cause significant modifications in the microbiota profile of the whole group, except for a tendency ( p  = 0.059) towards a decrease in the proportion of Lactobacilliales, while it increased the proportion of  Bacteroides  in non-responder subjects.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ramos-Romero', 'Affiliation': 'Institute of Advanced Chemistry of Catalonia (IQAC-CSIC), Jordi Girona 18-26, 08034 Barcelona, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martínez-Maqueda', 'Affiliation': 'Department of Metabolism and Nutrition, Institute of Food Science, Technology and Nutrition (ICTAN-CSIC), José Antonio Novais 10, 28040 Madrid, Spain.'}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Hereu', 'Affiliation': 'Institute of Advanced Chemistry of Catalonia (IQAC-CSIC), Jordi Girona 18-26, 08034 Barcelona, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Amézqueta', 'Affiliation': ""Departament d'Enginyeria Química i Química Analítica, Institut de Biomedicina (IBUB), Universitat de Barcelona, Carrer de Martí i Franquès, 1-11, 08028 Barcelona, Spain.""}, {'ForeName': 'Josep Lluís', 'Initials': 'JL', 'LastName': 'Torres', 'Affiliation': 'Institute of Advanced Chemistry of Catalonia (IQAC-CSIC), Jordi Girona 18-26, 08034 Barcelona, Spain.'}, {'ForeName': 'Jara', 'Initials': 'J', 'LastName': 'Pérez-Jiménez', 'Affiliation': 'Department of Metabolism and Nutrition, Institute of Food Science, Technology and Nutrition (ICTAN-CSIC), José Antonio Novais 10, 28040 Madrid, Spain.'}]","Foods (Basel, Switzerland)",['10.3390/foods9091279']
1716,32933510,"The PrEPARE Pretoria Project: protocol for a cluster-randomized factorial-design trial to prevent HIV with PrEP among adolescent girls and young women in Tshwane, South Africa.","BACKGROUND


Despite increased prevention efforts, HIV remains the leading cause of death among adolescent girls and young women in South Africa. Although research indicates important determinants of HIV acquisition at the individual and interpersonal levels, structural-level stigma and discrimination continue to be critical barriers to reaching and retaining this key population for HIV prevention and sexual and reproductive health services. Innovative and multilevel interventions are needed that can address the intersectional structural and gender issues that young women face, including stigma, alcohol and drug use, gender-based violence, and other risk factors when seeking health services. Oral pre-exposure prophylaxis (PrEP) taken daily has been found to be an effective biomedical HIV prevention tool. Testing a comprehensive gender-focused biobehavioral HIV prevention intervention that is inclusive of social ecological determinants, such as stigma and discrimination reduction in clinics, is critical for reducing HIV among adolescent girls and young women.
METHODS


This project involves both a Community Collaborative Board and a Youth Advisory Board in helping to adapt the Young Women's Health CoOp intervention and the Health Policy Project (HPP) Stigma and Discrimination (S&D) reduction training curriculum to the setting and population. This study uses a two-by-two factorial design with stratified randomization of 12 clinics, each with distinct catchment areas. The Young Women's Health CoOp addresses substance use, sexual risk, violence prevention and sexual negotiation, condom demonstration, and problem solving with the following additions: knowledge of PrEP, the importance of PrEP adherence, and sexual and reproductive health. Adolescent girls and young women will be assessed with behavioral and biological measures at baseline, 3-, 6- and 9-month follow-up. The S&D reduction training is provided for all staff in the clinics randomized to this condition. Clinic staff will be surveyed at baseline, 4- and 8-month follow-up. We will recruit 900 AGYW from communities in the 12 clinic catchment areas.
DISCUSSION


The study findings, if efficacious across the outcomes, will be incorporated into the gender-focused HIV prevention intervention toolkit and disseminated to inform multilevel prevention approaches.
TRIAL REGISTRATION


ClinicalTrials.gov. Identifier: NCT04048551 (Recruiting). Registered: August 7, 2019 (Retrospectively registered).",2020,"The Young Women's Health CoOp addresses substance use, sexual risk, violence prevention and sexual negotiation, condom demonstration, and problem solving with the following additions: knowledge of PrEP, the importance of PrEP adherence, and sexual and reproductive health.","['adolescent girls and young women in South Africa', '900 AGYW from communities in the 12 clinic catchment areas', '12 clinics, each with distinct catchment areas', 'adolescent girls and young women', 'Adolescent girls and young women', 'adolescent girls and young women in Tshwane, South Africa']","['biobehavioral HIV prevention intervention', 'HIV with PrEP', 'Oral pre-exposure prophylaxis (PrEP']",[],"[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0007403', 'cui_str': 'Health Catchment Area'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",[],,0.0318294,"The Young Women's Health CoOp addresses substance use, sexual risk, violence prevention and sexual negotiation, condom demonstration, and problem solving with the following additions: knowledge of PrEP, the importance of PrEP adherence, and sexual and reproductive health.","[{'ForeName': 'Wendee M', 'Initials': 'WM', 'LastName': 'Wechsberg', 'Affiliation': 'Substance Use, Gender, and Applied Research Program, RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA. wmw@rti.org.'}, {'ForeName': 'Felicia A', 'Initials': 'FA', 'LastName': 'Browne', 'Affiliation': 'Substance Use, Gender, and Applied Research Program, RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Ndirangu', 'Affiliation': 'Substance Use, Gender, and Applied Research Program, RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA.'}, {'ForeName': 'Courtney Peasant', 'Initials': 'CP', 'LastName': 'Bonner', 'Affiliation': 'Substance Use, Gender, and Applied Research Program, RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Minnis', 'Affiliation': 'Center for Global Health, RTI International, 2150 Shattuck Avenue, Suite 800, Berkeley, CA, 94704, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Nyblade', 'Affiliation': 'International Global Health Division, International Development Group, RTI International, 701 13th Street NW #750, Washington, DC, 20005, USA.'}, {'ForeName': 'Ilene S', 'Initials': 'IS', 'LastName': 'Speizer', 'Affiliation': 'Maternal and Child Health, University of North Carolina Gillings School of Global Public Health, 135 Dauer Drive, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Brittni N', 'Initials': 'BN', 'LastName': 'Howard', 'Affiliation': 'Substance Use, Gender, and Applied Research Program, RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Myers', 'Affiliation': 'Alcohol and Drug Abuse Research Unit, Medical Research Council Francie van Zijl Drive, Parow Valley, Cape Town, South Africa.'}, {'ForeName': 'Khatija', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': 'Setshaba Research Centre, 2088 Block H, Soshanguve, 0152, South Africa.'}]",BMC public health,['10.1186/s12889-020-09458-y']
1717,32934904,Effect of simulation modules on Jordanian nursing student knowledge and confidence in performing critical care skills: A randomized controlled trial.,"Background


Simulation is known to have a significant effect as a teaching strategy in nursing education. However, no studies have been conducted to examine the effect of simulation on nursing students' knowledge and confidence in performing critical care skills in Jordan .
Purpose


This study aimed to test the effect of simulation on university nursing students' knowledge and confidence in performing critical care skills for patients with cardiac, respiratory and neurological health problems.
Method


A randomized controlled (pre-test-post-test) design was implemented. The experimental group (n = 38) attended 9 simulation scenarios, theoretical lectures and clinical training in hospital about cardiac, respiratory and neurological health problems, while the control group (n = 38) attended only the theoretical lectures and clinical training in hospital. Knowledge and confidence were measured using knowledge exam and self-confidence scale respectively.
Results


A paired  t -test indicated that mean knowledge and confidence regarding implementing critical care skills were significantly higher  P < 0.001  in the post-test than that in the pre-test, in both the experimental and the control group. However, independent  t  test revealed that the students in the experimental group scored significantly higher  P < 0.001  than control group in both knowledge and confidence regarding performing critical care skills.
Conclusion


Theoretical and clinical training is valuable teaching strategies that help enhance knowledge and confidence in applying critical care skills. However, adding simulation has a more significant effect than theoretical and clinical training in improving nursing students' knowledge and confidence in performing critical care nursing skills. Author strongly recommended considering simulation as alternative effective educational approach for clinical training especially during COVID-pandemic.",2020,"A paired t-test indicated that mean knowledge and confidence regarding implementing critical care skills were significantly higher  P< 0.001  in the post-test than that in the pre-test, in both the experimental and the control group.","['patients with cardiac, respiratory and neurological health problems', 'Jordanian Nursing Student Knowledge and Confidence in Performing Critical Care Skills', 'university nursing students']","['simulation modules', '9 simulation scenarios, theoretical lectures and clinical training in hospital about cardiac, respiratory and neurological health problems, while the control group (n=38) attended only the theoretical lectures and clinical training in hospital']",['mean knowledge and confidence regarding implementing critical care skills'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}]",,0.0534543,"A paired t-test indicated that mean knowledge and confidence regarding implementing critical care skills were significantly higher  P< 0.001  in the post-test than that in the pre-test, in both the experimental and the control group.","[{'ForeName': 'Loai I', 'Initials': 'LI', 'LastName': 'Tawalbeh', 'Affiliation': 'Princess Salma Faculty of Nursing, Al-al-Bayt University, Al-Mafraq, P.O. Box: 130040, 25113, Jordan.'}]",International journal of Africa nursing sciences,['10.1016/j.ijans.2020.100242']
1718,32935287,Open-Label Assessment of the Effects of Itraconazole and Rifampicin on Balovaptan Pharmacokinetics in Healthy Volunteers.,"INTRODUCTION


Balovaptan, an investigational vasopressin 1a receptor antagonist that has been evaluated for improvement of social communication and interaction, is primarily metabolized by cytochrome P450 3A4 (CYP3A4).
METHODS


Two single-center, non-randomized, two-period, phase 1 studies assessed the effect of the strong CYP3A4 inhibitor itraconazole (study NCT03579719) or the strong CYP3A4 inducer rifampicin (study NCT03586726) at steady state on the pharmacokinetics (PK) of steady-state balovaptan in healthy volunteers. Participants received balovaptan (5 or 10 mg/day) alone for 10 days, or in combination with itraconazole (200 mg/day) for 15 days, or rifampicin (600 mg/day) for 10 days, following balovaptan washout and itraconazole/rifampicin pre-dosing. Geometric mean ratios (GMRs) and 90% confidence intervals (90% CIs) for the area under the concentration-time curve over the dosing interval (AUC) and maximum plasma concentration (C max ) of balovaptan dosed with vs. without itraconazole/rifampicin were estimated from a mixed effects model.
RESULTS


Both studies comprised 15-16 healthy male and female volunteers. Itraconazole 200 mg/day elevated steady-state exposure to 5 mg/day balovaptan approximately 4.5-5.5-fold (Day 15 GMR [90% CI], 4.46 [4.06-4.90] for C max  and 5.57 [5.00-6.21] for AUC) and extended the time to steady state from ~ 5 days to ~ 13-14 days. Rifampicin 600 mg/day resulted in ~ 90% reductions in both the C max  (Day 10 GMR [90% CI], 0.14 [0.12-0.15]) and AUC (0.07 [0.06-0.07]) of balovaptan 10 mg/day. Time to balovaptan steady state could not be determined with rifampicin. There were no clinically significant safety findings in either study.
CONCLUSIONS


Strong modulators of CYP3A4 activity will significantly alter the PK of balovaptan, with the effect of CYP3A4 induction greater than that of inhibition. Caution should be taken when concomitantly dosing balovaptan with moderate or strong CYP3A4 inducers or strong CYP3A4 inhibitors.
TRIAL REGISTRATION NUMBER


NCT03579719; NCT03586726.",2020,"(Day 15 GMR [90% CI], 4.46 [4.06-4.90] for C max  and 5.57 [5.00-6.21] for AUC) and extended the time to steady state from ~ ","['Healthy Volunteers', 'healthy volunteers', '15-16 healthy male and female volunteers']","['Rifampicin', 'Itraconazole 200\xa0mg/day elevated steady-state exposure to 5', 'itraconazole/rifampicin', 'balovaptan washout and itraconazole/rifampicin pre-dosing', 'strong CYP3A4 inhibitor itraconazole (study NCT03579719) or the strong CYP3A4 inducer rifampicin (study NCT03586726) at steady state on the pharmacokinetics (PK) of steady-state balovaptan', 'balovaptan (5 or 10\xa0mg/day) alone for 10\xa0days, or in combination with itraconazole', 'rifampicin', 'Itraconazole and Rifampicin']","['Balovaptan Pharmacokinetics', 'Geometric mean ratios (GMRs', 'time to steady state from\u2009', 'concentration-time curve over the dosing interval (AUC) and maximum plasma concentration (C max ']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C2917463', 'cui_str': 'Itraconazole 200 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C1142644', 'cui_str': 'cytochrome P450 3A4 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",,0.036334,"(Day 15 GMR [90% CI], 4.46 [4.06-4.90] for C max  and 5.57 [5.00-6.21] for AUC) and extended the time to steady state from ~ ","[{'ForeName': 'Michael G M', 'Initials': 'MGM', 'LastName': 'Derks', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK. michael.derks@roche.com.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wandel', 'Affiliation': 'F. Hoffmann-La Roche AG, Basel, Switzerland.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Young', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Stuart K', 'Initials': 'SK', 'LastName': 'Bolt', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Meyenberg', 'Affiliation': 'F. Hoffmann-La Roche AG, Basel, Switzerland.'}]",Advances in therapy,['10.1007/s12325-020-01491-y']
1719,32935662,Providing Unique Support for Health Study Among Young Black and Latinx Men Who Have Sex With Men and Young Black and Latinx Transgender Women Living in 3 Urban Cities in the United States: Protocol for a Coach-Based Mobile-Enhanced Randomized Control Trial.,"BACKGROUND


The US National HIV/AIDS Strategy 2020 calls for increasing access to care, improving outcomes of people living with HIV, and targeting biomedical prevention efforts, including access to pre-exposure prophylaxis (PrEP) in communities where HIV is most heavily concentrated. The cities of Baltimore, Maryland (MD); Washington, DC; and Philadelphia, Pennsylvania (PA) are disproportionately burdened by high rates of new cases of HIV infection, with high prevalence among young Black and Latinx men who have sex with men (YBLMSM) and young Black and Latinx transgender women (YBLTW) aged 15-24 years.
OBJECTIVE


This study aims (1) to identify and recruit YBLMSM and YBLTW who are at risk or living with HIV in Baltimore, MD; Philadelphia, PA; and Washington, DC, using respondent-driven sampling (RDS) with targeted seed selection, and (2) to assess the efficacy of a coach-based mobile-enhanced intervention (MEI) compared with standard of care (SOC) to increase successful engagement and retention into HIV, PrEP, and substance use treatment care across the HIV care and prevention continua in 3 Mid-Atlantic cities. This paper describes the protocol and progress as of October 20, 2019.
METHODS


This study uses a multiphase mixed methods design. The first phase is a formative, qualitative research with focus group discussions and key informant interviews. The second phase consists of evaluating the ability of RDS with targeted seed selection. The third phase includes 2 embedded randomized controlled trials (RCTs), where participants complete a baseline sociobehavioral survey, rapid HIV testing, and eligible youth enroll in parallel status-dependent RCTs that randomize the participant to 1 of 2 study arms: MEI with coach or SOC. Participants are asked to complete a web-based survey and provide biologic specimens-HIV-1 RNA (viral load) or HIV-1 antibody test and urine drug screen-at baseline and at 3, 6, and 12 months, and an exit interview at 18 months.
RESULTS


A formative qualitative research was conducted in February 2017 and May 2018, and this led to further refinement of recruitment and study methods. Aim 1 recruitment began in September 2017 with subsequent enrollment into the RCTs. Recruitment is ongoing with 520 participants screened and 402 (77.3%) enrolled in aim 1 by October 2020. Of these, 159 are enrolled in the 2 randomized trials: 36 (22.6%) HIV-positive not virally suppressed (aim 2) and 123 (77.4%) high-risk HIV-negative (aim 3).
CONCLUSIONS


This study has the potential to significantly impact the medical and substance use services provided to YBLMSM and YBLTW in the United States by providing rigorous scientific evidence outlining approaches and strategies that improve the uptake and engagement of YBLMSM and YBLTW in the HIV treatment and prevention continuum.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03194477; https://clinicaltrials.gov/ct2/show/NCT03194477.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17269.",2020,"This study has the potential to significantly impact the medical and substance use services provided to YBLMSM and YBLTW in the United States by providing rigorous scientific evidence outlining approaches and strategies that improve the uptake and engagement of YBLMSM and YBLTW in the HIV treatment and prevention continuum.
","['159 are enrolled in the 2 randomized trials: 36 (22.6%) HIV-positive not virally suppressed (aim 2) and 123 (77.4%) high-risk HIV-negative (aim 3', 'Young Black and Latinx Men', 'young Black and Latinx men who have sex with men (YBLMSM) and young Black and Latinx transgender women (YBLTW) aged 15-24 years', 'Living in 3 Urban Cities in the United States', 'Who Have Sex With Men and Young Black and Latinx Transgender Women', '520 participants screened and 402 (77.3%) enrolled in aim 1 by October 2020', 'September 2017 with subsequent enrollment into the RCTs']","['MEI with coach or SOC', 'coach-based mobile-enhanced intervention (MEI) compared with standard of care (SOC']",[],"[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3711547', 'cui_str': 'AURKB protein, human'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.144469,"This study has the potential to significantly impact the medical and substance use services provided to YBLMSM and YBLTW in the United States by providing rigorous scientific evidence outlining approaches and strategies that improve the uptake and engagement of YBLMSM and YBLTW in the HIV treatment and prevention continuum.
","[{'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Arrington-Sanders', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Hailey-Fair', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wirtz', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Cos', 'Affiliation': 'Public Health Management Corporation Research & Evaluation Group, Philadelphia, PA, United States.'}, {'ForeName': 'Noya', 'Initials': 'N', 'LastName': 'Galai', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Durryle', 'Initials': 'D', 'LastName': 'Brooks', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Marne', 'Initials': 'M', 'LastName': 'Castillo', 'Affiliation': ""The Adolescent Initiative, Children's Hospital of Philadelphia, Philadelphia, MD, United States.""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Dowshen', 'Affiliation': ""Craig Dalsimer Division of Adolescent Medicine, Children's Hospital of Philadelphia, Philadelphia, MD, United States.""}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Trexler', 'Affiliation': ""Adolescent Clinical Research Burgess Clinic, Children's National Medical Center, Washington, DC, United States.""}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': ""D'Angelo"", 'Affiliation': ""Adolescent Clinical Research Burgess Clinic, Children's National Medical Center, Washington, DC, United States.""}, {'ForeName': 'Jennafer', 'Initials': 'J', 'LastName': 'Kwait', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Beyrer', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Morgan', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Celentano', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}]",JMIR research protocols,['10.2196/17269']
1720,32936675,Prognosticating Outcomes and Nudging Decisions with Electronic Records in the ICU (PONDER-ICU) Trial Protocol.,"Expert recommendations to discuss prognosis and offer palliative options for critically ill patients at high risk of death are variably heeded by intensive care unit (ICU) clinicians. How to best promote such communication to avoid potentially unwanted aggressive care is unknown. The Prognosticating Outcomes and Nudging Decisions with Electronic Records in the ICU (PONDER-ICU) study is a 33-month pragmatic, stepped-wedge, cluster randomized trial testing the effectiveness of two electronic health record (EHR) interventions designed to increase ICU clinicians' engagement of critically ill patients at high risk of death and their caregivers in discussions about all treatment options, including care focused on comfort. We hypothesize that the quality of care and patient-centered outcomes can be improved by requiring ICU clinicians to document a functional prognostic estimate (Intervention A) and/or to provide justification if they have not offered patients the option of comfort-focused care (Intervention B). The trial enrolls all adult patients admitted to 17 ICUs in 10 hospitals in North Carolina with a pre-existing life-limiting illness and acute respiratory failure requiring continuous mechanical ventilation for at least 48 hours. Eligibility is determined using a validated algorithm in the EHR. The sequence in which hospitals transition from usual care (control), to intervention A or B, and then to combined interventions A + B, is randomly assigned. The primary outcome is hospital length of stay. Secondary outcomes include other clinical outcomes, palliative care process measures, and nurse-assessed quality of dying and death. Trial registration: ClinicalTrials.gov Identifier NCT03139838.",2020,"The Prognosticating Outcomes and Nudging Decisions with Electronic Records in the ICU (PONDER-ICU) study is a 33-month pragmatic, stepped-wedge, cluster randomized trial testing the effectiveness of two electronic health record (EHR) interventions designed to increase ICU clinicians' engagement of critically ill patients at high risk of death and their caregivers in discussions about all treatment options, including care focused on comfort.","['adult patients admitted to 17 ICUs in 10 hospitals in North Carolina with a pre-existing life-limiting illness and acute respiratory failure requiring continuous mechanical ventilation for at least 48 hours', 'critically ill patients at high risk of death and their caregivers in discussions', 'critically ill patients at high risk of death are variably heeded by intensive care unit (ICU) clinicians']",['electronic health record (EHR) interventions'],"['clinical outcomes, palliative care process measures, and nurse-assessed quality of dying and death', 'hospital length of stay']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0086850', 'cui_str': 'Process Measures'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.145145,"The Prognosticating Outcomes and Nudging Decisions with Electronic Records in the ICU (PONDER-ICU) study is a 33-month pragmatic, stepped-wedge, cluster randomized trial testing the effectiveness of two electronic health record (EHR) interventions designed to increase ICU clinicians' engagement of critically ill patients at high risk of death and their caregivers in discussions about all treatment options, including care focused on comfort.","[{'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Courtright', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, 14640, Medicine, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Erich M', 'Initials': 'EM', 'LastName': 'Dress', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, 14640, Palliative and Advanced Illness Research (PAIR) Center, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Jaspal', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Atrium Health, 2351, Critical Care Network, Adult Acute Division and Department of Medicine, Charlotte, North Carolina, United States.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Bayes', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, 14640, Palliative and Advanced Illness Research (PAIR) Center, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Marzana', 'Initials': 'M', 'LastName': 'Chowdhury', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, 14640, Palliative and Advanced Illness Research (PAIR) Center, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'Small', 'Affiliation': 'University of Pennsylvania Wharton School, 25825, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Hetherington', 'Affiliation': 'Atrium Health, 2351, Center for Outcomes Research & Evaluation (CORE), Charlotte, North Carolina, United States.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Plickert', 'Affiliation': 'Atrium Health, 2351, Information and Analytics Services, Charlotte, North Carolina, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Detsky', 'Affiliation': 'Sinai Health System, 518775, Medicine, Toronto, Ontario, Canada.'}, {'ForeName': 'Jason N', 'Initials': 'JN', 'LastName': 'Doctor', 'Affiliation': 'University of Southern California, 5116, Department of Health Policy and Management, Sol Price School of Public Policy, Los Angeles, California, United States.'}, {'ForeName': 'Michael O', 'Initials': 'MO', 'LastName': 'Harhay', 'Affiliation': 'University of Pennsylvania, 6572, Biostatistics, Epidemiology and Informatics, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Henry L', 'Initials': 'HL', 'LastName': 'Burke', 'Affiliation': 'Atrium Health, 2351, Division of Palliative Care, Adult Acute Care Services and Department of Medicine, Charlotte, North Carolina, United States.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Green', 'Affiliation': 'Atrium Health, 2351, Critical Care Network, Adult Acute Division and Department of Medicine, Charlotte, North Carolina, United States.'}, {'ForeName': 'Toan', 'Initials': 'T', 'LastName': 'Huynh', 'Affiliation': 'Atrium Health, 2351, Division of Trauma, Surgical Critical Care, and Acute Care Surgery, Department of General Surgery, Charlotte, North Carolina, United States.'}, {'ForeName': 'D Matthew', 'Initials': 'DM', 'LastName': 'Sullivan', 'Affiliation': 'Atrium Health, 2351, Information and Analytics Services, Charlotte, North Carolina, United States.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Halpern', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, 14640, Medicine, Philadelphia, Pennsylvania, United States.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202002-088SD']
1721,32937273,"Short-term and long-term effects of ankle joint taping and bandaging on balance, proprioception and vertical jump among volleyball players with chronic ankle instability.","OBJECTIVE


This study hypothesized that the prolonged use of taping during athletic activities produces more significant increases in proprioception, balance, and vertical jump among volleyball players with CAI.
DESIGN


A randomized controlled study.
PARTICIPANTS


One-hundred participants with chronic ankle instability (CAI) participated in this study. Participants were distributed into 3-groups: taping group, bandaging group, and control group.
PRIMARY OUTCOME MEASURES


Proprioception (ankle range of motion absolute error), balance(Y-balance test), and vertical jump (vertical jump tester).
INTERVENTIONS


Three interventions were performed: ankle rigid taping, ankle bandaging, and placebo taping. The measurements were performed at baseline, immediately, 2-weeks and 2-months after support.
RESULTS


Immediately after supports, there were non-significant differences between all groups for proprioception, balance (P < .05). There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P < .05). After 2-weeks and 2-months, there were significant differences between bandaging and control groups, and taping and control groups for proprioception, balance, and vertical jump (P < .05). There were non-significant differences between taping and bandaging groups (P < .05) during all assessments.
CONCLUSION


This study indicated that ankle taping and bandaging immediately improve vertical jump only; while they improve proprioception, balance, and vertical jump after 2-weeks and 2-months.",2020,"There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P ","['One-hundred participants with chronic ankle instability (CAI) participated in this study', 'volleyball players with CAI', 'volleyball players with chronic ankle instability']","['ankle joint taping and bandaging', 'taping group, bandaging group, and control group', 'ankle rigid taping, ankle bandaging, and placebo taping']","['proprioception, balance, and vertical jump', 'proprioception, balance, and vertical jump (P', 'Proprioception (ankle range of motion absolute error), balance(Y-balance test), and vertical jump (vertical jump tester', 'proprioception, balance', 'balance, proprioception and vertical jump']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}]","[{'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0183885', 'cui_str': 'Tester'}]",100.0,0.0294532,"There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P ","[{'ForeName': 'Motaz', 'Initials': 'M', 'LastName': 'Alawna', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, School of Health Sciences, Istanbul Gelisim University, Istanbul, Turkey. Electronic address: malawna@gelisim.edu.tr.'}, {'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, School of Health Sciences, Istanbul Gelisim University, Istanbul, Turkey. Electronic address: amohamed@gelisim.edu.tr.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.08.015']
1722,32942788,Relationship Between Epidural Steroid Dose and Suppression of Hypothalamus-Pituitary-Adrenal Axis.,"BACKGROUND


The suppression of hypothalamic-pituitary-adrenal (HPA) axis is a common complication associated with epidural steroid injections (ESIs). However, the effect of different doses is unknown.
OBJECTIVES


The primary objective was to compare the differences in the duration of HPA suppression following treatment with different doses of ESI; triamcinolone acetate (TA) 40 mg and TA 20 mg. The secondary objectives were to compare the extent of salivary cortisol (SC) reduction, the incidence of adrenal insufficiency (AI), and the differences in a numeric rating scale (NRS) depending on the varying levels of TA dose used for ESI.
STUDY DESIGN


A double-blind, parallel-group, randomized controlled trial.
SETTING


Pain clinics in a university hospital.
METHODS


The patients were treated with TA epidurally and divided into 2 groups (T20 and T40) depending on the dose of TA (20 mg and 40 mg). The SC concentration was measured before and after ESI to calculate the duration of HPA axis suppression, the extent of SC concentration reduction, and the SC recovery rate. Additionally, NRS and adrenocorticotropic hormone stimulation tests were used.
RESULTS


Thirty patients were analyzed. The T40 group showed longer HPA suppression (19.7 ± 3.1 days) compared with that of the T20 group (8.0 ± 2.4 days). The recovery rate of the T40 group was lower than that of the T20 group (P < 0.015). However, there was no difference in the extent of reduction in SC concentration after ESI, the occurrence of AI, and pain reduction.
LIMITATIONS


There were selection bias and no placebo control.
CONCLUSIONS


Although the difference in pain relief according to the ESI dose is not significant, the HPA suppression is prolonged with a higher dose than a lower dose, and the recovery is slower. Therefore, the time interval between consecutive ESIs should be adjusted depending on the steroid dose to ameliorate the adverse effects of steroids.",2020,The recovery rate of the T40 group was lower than that of the T20 group (P < 0.015).,"['Thirty patients were analyzed', 'Pain clinics in a university hospital']","['TA', 'ESI; triamcinolone acetate (TA']","['duration of HPA axis suppression', 'SC concentration after ESI, the occurrence of AI, and pain reduction', 'pain relief', 'SC concentration', 'longer HPA suppression', 'duration of HPA suppression', 'recovery rate', 'extent of salivary cortisol (SC) reduction, the incidence of adrenal insufficiency (AI), and the differences in a numeric rating scale (NRS) depending on the varying levels of TA dose used for ESI', 'HPA suppression']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242936', 'cui_str': 'Pain clinic'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0142580', 'cui_str': 'PI3 protein, human'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3665848', 'cui_str': 'Hypothalamic pituitary adrenal axis suppression'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0142580', 'cui_str': 'PI3 protein, human'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0001623', 'cui_str': 'Hypoadrenalism'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0271738', 'cui_str': 'Hypocortisolism secondary to another disorder'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",30.0,0.0473564,The recovery rate of the T40 group was lower than that of the T20 group (P < 0.015).,"[{'ForeName': 'Sung-Eun', 'Initials': 'SE', 'LastName': 'Sim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Hyo Ju', 'Initials': 'HJ', 'LastName': 'Hong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Kyungmoon', 'Initials': 'K', 'LastName': 'Roh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Jaeho', 'Initials': 'J', 'LastName': 'Seo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Ho Sik', 'Initials': 'HS', 'LastName': 'Moon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}]",Pain physician,[]
1723,32942789,"Comparing the Safety and Effectiveness of Radiofrequency Thermocoagulation on Genicular Nerve, Intraarticular Pulsed Radiofrequency with Steroid Injection in the Pain Management of Knee Osteoarthritis.","BACKGROUND


Knee osteoarthritis (KOA) is characterized by the clinical symptoms of chronic knee pain and knee dysfunction, leading to disability and influencing the quality of life in severe cases. Radiofrequency treatment is a new method to reduce KOA-related pain and partially improve knee joint dysfunction without adverse effect.
OBJECTIVE


The present study aimed to assess the treatment efficacy of radiofrequency thermocoagulation on the genicular nerve (RFTGN) and intraarticular pulsed radiofrequency (IAPRF) for KOA.
STUDY DESIGN


Retrospective comparative study design.
SETTING


This study took place at Shengjing Hospital of China Medical University.
METHOD


KOA patients were randomly assigned to the RFTGN, IAPRF, and intraarticular steroid injection (IAS) groups. All procedures were performed under the guidance of computed tomography (CT). The observation indicators of this study were the numeric rating scale (NRS), Oxford knee scale (OKS), and perceived global effect (GPE). The time points for the assessment were 1-week, 1-month, 3-months, and 6-months after the treatment.
RESULTS


The postoperative NRS scores in the 3 groups decreased significantly at all the observation time points as compared to the pretreatment scores (P < 0.05). For the patients in the IAS group, the analgesic effect was in a rebound trend, which was the best at 1-week posttreatment, and was close to the preoperative level at 6-months posttreatment. The short-term (1 week or 1 month) analgesic effect of the RFTGN group was better than that of the IAPRF group, and was similar in the long-term (3 or 6 months). The long-term analgesic effect of RFTGN and IAPRF groups was better than that of IAS group. The results of the OKS score were similar to the NRS score. The RFTGN group showed markedly improved knee function in the long-term than the IAPRF and IAS groups. The short-term treatment satisfaction was similar in each group, and some differences were detected between the groups with respect to long-term treatment satisfaction.
LIMITATION


This study was a single-center retrospective study with a relatively small sample cohort and short follow-up periodCONCLUSION: Both RFTGN and IAPRF could alleviate the knee joint pain and improve the knee joint dysfunction; however, the treatment efficacy of RFTGN was better than that of IAPRF.",2020,The postoperative NRS scores in the 3 groups decreased significantly at all the observation time points as compared to the pretreatment scores (P < 0.05).,"['Knee osteoarthritis (KOA', 'KOA patients', 'Knee Osteoarthritis', 'place at Shengjing Hospital of China Medical University']","['radiofrequency thermocoagulation', 'Radiofrequency Thermocoagulation', 'IAS', 'intraarticular pulsed radiofrequency (IAPRF', 'RFTGN and IAPRF', 'computed tomography (CT', 'Steroid Injection', 'Radiofrequency treatment', 'RFTGN, IAPRF, and intraarticular steroid injection (IAS', 'IAPRF']","['numeric rating scale (NRS), Oxford knee scale (OKS), and perceived global effect (GPE', 'analgesic effect', 'knee function', 'knee joint pain', 'short-term treatment satisfaction', 'knee joint dysfunction', 'postoperative NRS scores', 'OKS score']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0908952', 'cui_str': 'iodoazidosalmeterol'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0214505,The postoperative NRS scores in the 3 groups decreased significantly at all the observation time points as compared to the pretreatment scores (P < 0.05).,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yao', 'Affiliation': 'Department of Pain Management, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Hong', 'Affiliation': 'Department of Pain Management, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Guangxiao', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Shengjing Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Zhenkai', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'Shengjing Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Shimeng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Shengjing Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Pain Management, Shengjing Hospital of China Medical University, Shenyang, China.'}]",Pain physician,[]
1724,32950939,Feasibility and efficacy of a digital CBT intervention for symptoms of Generalized Anxiety Disorder: A randomized multiple-baseline study.,"BACKGROUND AND OBJECTIVES


Cognitive behavioral therapy (CBT) is a first-line treatment for anxiety, but it is not widely available as clinical guidelines recommend. We examined the feasibility and efficacy of a novel smartphone-based fully automated digital CBT intervention, 'Daylight™', to improve symptoms of Generalized Anxiety Disorder (GAD).
METHODS


In this multiple-baseline design, 21 adults (20 F; mean age 43yrs. range 19-65yrs.) with moderate-to-severe symptoms of GAD were randomized to one of three baseline durations (2-, 4-, or 6-weeks) and then received access to digital CBT. Participants completed daily ratings of anxiety and worry, weekly measures of anxiety, depressive symptoms, and sleep, and measures of anxiety, worry, wellbeing, quality of life, CBT skill acquisition, and work performance at initial assessment prior to baseline randomization, post-intervention, and follow-up.
RESULTS


Digital CBT was found to be feasible in terms of engagement, satisfaction, and safety. For preliminary efficacy, improvements were detected in daily and weekly outcomes of anxiety for most participants. Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline. Overall, 70% of participants no longer had clinically significant symptoms of GAD, 61% no longer had significant depressive symptoms, and 40% no longer had significant sleep difficulty at post-intervention.
LIMITATIONS


The study sample was recruited using the internet and was mostly female, limiting the generalizability of the findings.
CONCLUSIONS


Findings support the feasibility and efficacy of Daylight. Further examination in randomized controlled trials is now warranted.",2020,"Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline.","['21 adults (20\xa0F; mean age 43yrs', 'range 19-65yrs.) with moderate-to-severe symptoms of GAD', 'Generalized Anxiety Disorder']","['digital CBT intervention', ""novel smartphone-based fully automated digital CBT intervention, 'Daylight™"", 'Cognitive behavioral therapy (CBT']","['depressive symptoms', 'daily ratings of anxiety and worry, weekly measures of anxiety, depressive symptoms, and sleep, and measures of anxiety, worry, wellbeing, quality of life, CBT skill acquisition, and work performance at initial assessment prior to baseline randomization, post-intervention, and follow-up', 'Feasibility and efficacy', 'engagement, satisfaction, and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",21.0,0.0552773,"Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline.","[{'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Miller', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK. Electronic address: chris.miller@bighealth.com.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Alasdair L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Davis', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Stott', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Adrienne J', 'Initials': 'AJ', 'LastName': 'Heinz', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}, {'ForeName': 'Kate H', 'Initials': 'KH', 'LastName': 'Bentley', 'Affiliation': 'Derner School of Psychology, Adelphi University, Garden City, NY, USA.'}, {'ForeName': 'Guy M', 'Initials': 'GM', 'LastName': 'Goodwin', 'Affiliation': 'University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Bernard S', 'Initials': 'BS', 'LastName': 'Gorman', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Anxiety and Depression Research Centre (ADRC), UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Jenna R', 'Initials': 'JR', 'LastName': 'Carl', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101609']
1725,32954765,Effect of a two-way quality feedback nursing model on patients with chronic obstructive pulmonary disease.,"BACKGROUND


In recent years, the incidence of chronic obstructive pulmonary disease (COPD) has been increasing gradually, becoming a relatively intractable public health problem faced by all of society. The corresponding conventional nursing interventions are not effective for the rehabilitation of COPD patients and cannot meet clinical needs. In this study, a new nursing model, a two-way quality feedback nursing model, was applied for the treatment of COPD patients.
METHODS


This retrospective study included 120 moderate COPD patients admitted to our hospital between January 2018 and December 2018, and the patients were equally divided into the experimental group (n=60) and the control group (n=60) according to the nursing strategy received by patients. The control group received routine nursing care, the two-way quality feedback nursing model was applied in the experimental group, and the nursing effects in the two groups were compared.
RESULTS


The patient compliance of the experimental group to nursing care was 91.67%, that of the control group was 78.33% (P<0.05), and the scores for social relationship, environmental impact, psychological condition, and physiological condition of quality of life (QoL) in the experimental group at discharge were higher than those in the control group (P<0.05).
CONCLUSIONS


The application of the two-way quality feedback nursing model in COPD patients could improve patient compliance and significantly improve the QoL of patients, with good application value.",2020,"The patient compliance of the experimental group to nursing care was 91.67%, that of the control group was 78.33% (P<0.05), and the scores for social relationship, environmental impact, psychological condition, and physiological condition of quality of life (QoL) in the experimental group at discharge were higher than those in the control group (P<0.05).
","['patients with chronic obstructive pulmonary disease', 'chronic obstructive pulmonary disease (COPD', 'COPD patients', '120 moderate COPD patients admitted to our hospital between January 2018 and December 2018, and the patients were equally divided into the experimental group (n=60) and the control group (n=60) according to the nursing strategy received by patients']","['routine nursing care, the two-way quality feedback nursing model']","['scores for social relationship, environmental impact, psychological condition, and physiological condition of quality of life (QoL', 'nursing care']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0730605', 'cui_str': 'Moderate chronic obstructive pulmonary disease'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0079849', 'cui_str': 'Model, Nursing'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0282165', 'cui_str': 'Environmental Impact'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0028678', 'cui_str': 'nursing'}]",120.0,0.0132109,"The patient compliance of the experimental group to nursing care was 91.67%, that of the control group was 78.33% (P<0.05), and the scores for social relationship, environmental impact, psychological condition, and physiological condition of quality of life (QoL) in the experimental group at discharge were higher than those in the control group (P<0.05).
","[{'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Department of Geriatrics, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Yinhua', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Geriatrics, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Xiaolan', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Department of Geriatrics, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Fang', 'Affiliation': 'Department of Geriatrics, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China. fangfang7778@126.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1532']
1726,32954768,Randomized clinical trial to assess the mPADSS scale in recovery and home discharge after endoscopy.,"BACKGROUND


current clinical practice guidelines recommend the use of objective scales as a criterion for post-endoscopy sedation discharge.
OBJECTIVE


to assess the recovery time, complications and patient satisfaction level using the mPADSS scale.
MATERIAL AND METHODS


demographic data and medical history were collected. Vital signs, anxiety and abdominal pain were measured pre-endoscopy. Patients were randomized into a control group, discharged according to the usual practice, and the intervention group, who underwent the mPADSS scale every ten minutes, until an objective score was reached.
RESULTS


one hundred and eighteen patients were randomized (78 colonoscopies, 32 gastroscopies, three gastro + colonoscopies and 15 endoscopic retrograde cholangiopancreatographies/endoscopic ultrasound [ERCP/USE]). With regard to medical history, there were 36 cases of elevated blood pressure and 19 diabetes cases, 15 with anticoagulant/antiplatelet and 21 with hypnotic/anxiolytic medication. An average of 160 mg of propofol was required per patient, with additional flumazenil and midazolam in 49. There were two episodes of vomiting and three of mild desaturation, all of them in the control group. Sixty patients were included in the control group and 58 in the mPADSS group, who were discharged in 15 and 10 minutes on average respectively (p < 0.005); 24-48h telephone call follow-up data were available for 105 subjects. There were four readmissions (three control and one mPADSS). There were no differences in pain and post-sedation symptoms and the level of satisfaction in terms of attention and duration of stay was similar in both groups.
CONCLUSIONS


this study shows the efficiency, safety and patient satisfaction using the mPADSS scale. Thus, its use is recommend.",2020,"There were no differences in pain and post-sedation symptoms and the level of satisfaction in terms of attention and duration of stay was similar in both groups.
","['36 cases of elevated blood pressure and 19 diabetes cases, 15 with anticoagulant/antiplatelet and 21 with hypnotic/anxiolytic medication', 'Sixty patients were included in the control group and 58 in the mPADSS group, who were discharged in 15 and 10 minutes on average respectively (p < 0.005); 24-48h telephone call follow-up data were available for 105 subjects', 'one hundred and eighteen patients were randomized (78 colonoscopies, 32 gastroscopies, three', 'demographic data and medical history were collected']","['propofol', 'flumazenil and midazolam', 'gastro + colonoscopies and 15 endoscopic retrograde cholangiopancreatographies/endoscopic ultrasound [ERCP/USE']","['recovery time, complications and patient satisfaction level', 'pain and post-sedation symptoms and the level of satisfaction in terms of attention and duration of stay', 'efficiency, safety and patient satisfaction', 'Vital signs, anxiety and abdominal pain', 'vomiting']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4517389', 'cui_str': '0.005'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0016293', 'cui_str': 'Flumazenil'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",118.0,0.0716134,"There were no differences in pain and post-sedation symptoms and the level of satisfaction in terms of attention and duration of stay was similar in both groups.
","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'de Benito Sanz', 'Affiliation': 'Aparato Digestivo, Hospital Universitario Río Hortega, España.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Martínez de la Torre', 'Affiliation': 'Aparato Digestivo, Hospital Universitario Río Hortega.'}, {'ForeName': 'M ª Almudena', 'Initials': 'MªA', 'LastName': 'Salvador de Las Heras', 'Affiliation': 'Aparato Digestivo, Hospital Universitario Río Hortega.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Calleja Carbajosa', 'Affiliation': 'Aparato Digestivo, Hospital Universitario Río Hortega.'}, {'ForeName': 'Patricia Virginia', 'Initials': 'PV', 'LastName': 'Sesma Fernández', 'Affiliation': 'Aparato Digestivo, Hospital Universitario Río Hortega.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Pérez Sierra', 'Affiliation': 'Aparato Digestivo, Hospital Universitario Río Hortega.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'García-Alonso', 'Affiliation': 'Aparato Digestivo, Hospital Universitario Río Hortega, España.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Perez-Miranda', 'Affiliation': 'Aparato Digestivo, Hospital Universitario Río Hortega.'}]",Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva,['10.17235/reed.2020.6420/2019']
1727,32956906,Reality check: An experimental manipulation of inferential confusion in eating disorders.,"BACKGROUND AND OBJECTIVES


Inferential confusion (IC) entails confusing an imagined possibility with a sensory-based possibility, and acting upon the imagined possibility as if it was real. Although IC was formulated in the context of obsessive-compulsive disorder (OCD), this reasoning bias has shown to be relevant to other obsessive-compulsive spectrum disorders, such as eating disorders (EDs). The goal of this study was to induce IC experimentally in individuals with EDs relative to healthy controls (HC).
METHODS


Thirty-six women (ED group, n = 18; HC group, n = 18) were assigned to one of two experimental conditions: in the High IC condition, participants watched ED-themed videos with key sequences missing - provoking a distrust of the senses and lending more space for the imagination, thus triggering IC. In the Low IC condition, participants watched videos without sequences missing. Participants completed measures of IC, negative affect and compulsive behaviors after watching the videos.
RESULTS


One-way ANOVA indicated that ED participants assigned to the High IC condition reported a greater urge to engage in compulsive behaviors. ED participants also neutralized more after watching the videos and endorsed higher trait IC.
LIMITATIONS


There was no clinical control group.
CONCLUSIONS


These findings suggest that individuals with EDs display a greater vulnerability to IC, as they are more prone to compulsive behaviors when IC is triggered. This investigation may foster our understanding of the relationship between EDs and OCD through the examination of cognitive factors that are implicated in both disorders.",2020,ANOVA indicated that ED participants assigned to the High IC condition reported a greater urge to engage in compulsive behaviors.,"['Thirty-six women (ED group, n\xa0=\xa018', 'individuals with EDs relative to healthy controls (HC', 'eating disorders']","['watched ED-themed videos with key sequences missing - provoking a distrust of the senses and lending more space for the imagination, thus triggering IC']","['urge to engage in compulsive behaviors', 'IC, negative affect and compulsive behaviors']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C1867020', 'cui_str': 'Scalp, ear, nipple syndrome'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0020913', 'cui_str': 'Use of imagination'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",36.0,0.0589645,ANOVA indicated that ED participants assigned to the High IC condition reported a greater urge to engage in compulsive behaviors.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ouellet-Courtois', 'Affiliation': 'OCD Spectrum Study Center, Montreal Mental Health University Institute, 7331 Hochelaga Montreal, Quebec, H1N 3V2, Canada; Université de Montréal, Psychology Department, Canada. Electronic address: catherine.ouellet-courtois@umontreal.ca.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Aardema', 'Affiliation': 'OCD Spectrum Study Center, Montreal Mental Health University Institute, 7331 Hochelaga Montreal, Quebec, H1N 3V2, Canada; Université de Montréal, Psychiatry Department, 2900, Boul. Édouard-Montpetit Montreal, Quebec, H3T 1J4, Canada.'}, {'ForeName': 'Kieron', 'Initials': 'K', 'LastName': ""O'Connor"", 'Affiliation': 'OCD Spectrum Study Center, Montreal Mental Health University Institute, 7331 Hochelaga Montreal, Quebec, H1N 3V2, Canada; Université de Montréal, Psychiatry Department, 2900, Boul. Édouard-Montpetit Montreal, Quebec, H3T 1J4, Canada.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101614']
1728,32956960,Mental health promotion and prevention interventions in families with parental depression: A randomized controlled trial.,"BACKGROUND


The transgenerational transmission of affective disorders calls for integrating promotion of child development in the services offered to families with parental depression. The main objective of the present research was to examine the effectiveness and differences in the impact of two relevant interventions in Greece.
METHODS


Thirty families of depressed patients were randomly assigned to the six-to-eight session Family Talk Intervention group and 32 families were included in the lower intensity parent-only two-to-three session Let's Talk about the Children group. Depressed parents and the eldest of their children were assessed prior to the interventions and 4, 10, and 18 months following baseline assessment.
RESULTS


In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems. Child's prosocial behavior, perceived social support, and health-related quality of life were significantly improved in both groups. All positive effects were evident four months following baseline assessment and could be still documented at 1.5-year follow-up. Mixed linear models showed that family functioning and parenting to a lesser extent were associated with the greatest changes in children's psychosocial outcomes in both interventions..
LIMITATIONS


The lack of data regarding parents that refused to receive the interventions may limit generalizability of results. A further limitation is the lack of a no-intervention control group.
CONCLUSIONS


The study offers a preliminary evidence base for integrating preventive interventions for child mental health in routine clinical practice with adult depressed patients.",2020,"In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems.","['families with parental depression', 'Thirty families of depressed patients', 'child mental health in routine clinical practice with adult depressed patients']","['Mental health promotion and prevention interventions', 'six-to-eight session Family Talk Intervention group and 32 families were included in the lower intensity parent-only two-to-three session']","[""parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems"", ""Child's prosocial behavior, perceived social support, and health-related quality of life""]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",32.0,0.0624,"In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems.","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Giannakopoulos', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece. Electronic address: ggiannak@med.uoa.gr.'}, {'ForeName': 'Tytti', 'Initials': 'T', 'LastName': 'Solantaus', 'Affiliation': 'MIELI Mental Health Finland, Helsinki, Finland; Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Chara', 'Initials': 'C', 'LastName': 'Tzavara', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Kolaitis', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.070']
1729,32957571,Quercetin Supplementation Improves Neuromuscular Function Recovery from Muscle Damage.,"This study was aimed at investigating whether quercetin (Q) may improve the recovery of neuromuscular function and biochemical parameters in the 7 days following an eccentric exercise-induced muscle damage (EEIMD). Sixteen men (25.9 ± 3.3 y) ingested Q (1000 mg/day) or placebo (PLA) for 14 days following a double-blind crossover study design. A neuromuscular (NM) test was performed pre-post, 24 h, 48 h, 72 h, 96 h and 7 days after an intense eccentric exercise. The force-velocity relationship of the elbow flexor muscles and their maximal voluntary isometric contraction (MVIC) were recorded simultaneously to the electromyographic signals (EMG). Pain, joint angle, arm circumference, plasma creatine kinase (CK) and lactate-dehydrogenase (LDH) were also assessed. The results showed that Q supplementation significantly attenuated the strength loss compared to PLA. During the recovery, force-velocity relationship and mean fibers conduction velocity (MFCV) persisted significantly less when participants consumed PLA rather than Q, especially at the highest angular velocities ( p  < 0.02). A greater increase in biomarkers of damage was also evident in PLA with respect to Q. Q supplementation for 14 days seems able to ameliorate the recovery of eccentric exercise-induced weakness, neuromuscular function impairment and biochemical parameters increase probably due to its strong anti-inflammatory and antioxidant action.",2020,"During the recovery, force-velocity relationship and mean fibers conduction velocity (MFCV) persisted significantly less when participants consumed PLA rather than Q, especially at the highest angular velocities ( p  < 0.02).",['Sixteen men (25.9 ± 3.3 y) ingested Q (1000 mg/day) or'],"['quercetin (Q', 'Quercetin Supplementation', 'placebo (PLA']","['biomarkers of damage', 'force-velocity relationship of the elbow flexor muscles and their maximal voluntary isometric contraction (MVIC', 'recovery, force-velocity relationship and mean fibers conduction velocity (MFCV', 'strength loss', 'Pain, joint angle, arm circumference, plasma creatine kinase (CK) and lactate-dehydrogenase (LDH']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0858114', 'cui_str': 'Plasma creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}]",,0.231259,"During the recovery, force-velocity relationship and mean fibers conduction velocity (MFCV) persisted significantly less when participants consumed PLA rather than Q, especially at the highest angular velocities ( p  < 0.02).","[{'ForeName': 'Ilenia', 'Initials': 'I', 'LastName': 'Bazzucchi', 'Affiliation': 'Laboratory of Exercise Physiology, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Patrizio', 'Affiliation': 'Laboratory of Exercise Physiology, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Ceci', 'Affiliation': 'Laboratory of Biochemistry of Movement, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Guglielmo', 'Initials': 'G', 'LastName': 'Duranti', 'Affiliation': 'Laboratory of Biochemistry of Movement, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Sabatini', 'Affiliation': 'Laboratory of Biochemistry of Movement, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Sgrò', 'Affiliation': 'Endocrinology Unit, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Di Luigi', 'Affiliation': 'Endocrinology Unit, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Sacchetti', 'Affiliation': 'Laboratory of Exercise Physiology, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}]",Nutrients,['10.3390/nu12092850']
1730,32958377,Effect of motor imagery on enjoyment in knee-injury prevention and rehabilitation training: A randomized crossover study.,"OBJECTIVES


The novel MOTor Imagery to Facilitate Sensorimotor Re-Learning (MOTIFS) model takes a uniquely holistic approach by integrating mental and physical aspects into current training programs. The aim of this trial was to evaluate enjoyment of MOTIFS training as compared to Care-as-Usual (CaU) knee injury and/or rehabilitation training. The primary hypothesis was that enjoyment would be greater following MOTIFS training than CaU training.
DESIGN


Block-randomized 2×2 cross-over trial.
METHODS


Thirty athletes (18-31years, 50% women) currently or previously active in team ball sports, with no pain or injury preventing jump and/or directional changes. MOTIFS training integrates sport-specific experiences and equipment into physical exercises to increase individualized realism and meaning. The CaU condition included solely physical exercise. The main outcome was the Physical Activity Enjoyment Scale (PACES). Secondary outcomes included Self-Assessment Manikin (SAM; subscales Valence, Arousal, Dominance), Perceived exertion, pulse, duration, and movement quality.
RESULTS


PACES scores were better following MOTIFS training than CaU (point estimate 24.67; 95% CI: 19.0; 30.3). Between-groups differences in SAM Valence (median 2, quartiles 1;3), Arousal (median 1, quartiles 0;2.25), and Dominance (median 0.5, quartiles 0;2), and RPE (median 1, quartiles -0.3;2), training duration (mean 5.34, 95% CI: -0.17; -0.73), and pulse (median 7.50, quartiles 0.25;16.75) were higher following MOTIFS training than CaU training.
CONCLUSIONS


Results suggest that the MOTIFS model, which integrates simultaneous physical and psychological interventions, is a clinically plausible method of influencing enjoyment and other psychological outcomes. Further studies may explore effects of the MOTIFS principles on injury prevention and rehabilitation training.",2020,"RESULTS


PACES scores were better following MOTIFS training than CaU (point estimate 24.67; 95% CI: 19.0; 30.3).","['Thirty athletes (18-31years, 50% women) currently or previously active in team ball sports, with no pain or injury preventing jump']","['Care-as-Usual (CaU) knee injury and/or rehabilitation training', 'motor imagery', 'MOTIFS training']","['SAM Valence', 'training duration', 'Self-Assessment Manikin (SAM; subscales Valence, Arousal, Dominance), Perceived exertion, pulse, duration, and movement quality', 'Physical Activity Enjoyment Scale (PACES', 'RPE']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]","[{'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",30.0,0.0946022,"RESULTS


PACES scores were better following MOTIFS training than CaU (point estimate 24.67; 95% CI: 19.0; 30.3).","[{'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Cederström', 'Affiliation': 'Department of Health Sciences, Lund University, Sweden. Electronic address: niklas.cederstrom@med.lu.se.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Granér', 'Affiliation': 'Department of Psychology, Lund University, Sweden.'}, {'ForeName': 'Gustav', 'Initials': 'G', 'LastName': 'Nilsson', 'Affiliation': 'Malmö Idrottsklinik, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ageberg', 'Affiliation': 'Department of Health Sciences, Lund University, Sweden.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.09.004']
1731,32865380,Colchicine in Patients with Chronic Coronary Disease.,"BACKGROUND


Evidence from a recent trial has shown that the antiinflammatory effects of colchicine reduce the risk of cardiovascular events in patients with recent myocardial infarction, but evidence of such a risk reduction in patients with chronic coronary disease is limited.
METHODS


In a randomized, controlled, double-blind trial, we assigned patients with chronic coronary disease to receive 0.5 mg of colchicine once daily or matching placebo. The primary end point was a composite of cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization. The key secondary end point was a composite of cardiovascular death, spontaneous myocardial infarction, or ischemic stroke.
RESULTS


A total of 5522 patients underwent randomization; 2762 were assigned to the colchicine group and 2760 to the placebo group. The median duration of follow-up was 28.6 months. A primary end-point event occurred in 187 patients (6.8%) in the colchicine group and in 264 patients (9.6%) in the placebo group (incidence, 2.5 vs. 3.6 events per 100 person-years; hazard ratio, 0.69; 95% confidence interval [CI], 0.57 to 0.83; P<0.001). A key secondary end-point event occurred in 115 patients (4.2%) in the colchicine group and in 157 patients (5.7%) in the placebo group (incidence, 1.5 vs. 2.1 events per 100 person-years; hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P = 0.007). The incidence rates of spontaneous myocardial infarction or ischemia-driven coronary revascularization (composite end point), cardiovascular death or spontaneous myocardial infarction (composite end point), ischemia-driven coronary revascularization, and spontaneous myocardial infarction were also significantly lower with colchicine than with placebo. The incidence of death from noncardiovascular causes was higher in the colchicine group than in the placebo group (incidence, 0.7 vs. 0.5 events per 100 person-years; hazard ratio, 1.51; 95% CI, 0.99 to 2.31).
CONCLUSIONS


In a randomized trial involving patients with chronic coronary disease, the risk of cardiovascular events was significantly lower among those who received 0.5 mg of colchicine once daily than among those who received placebo. (Funded by the National Health Medical Research Council of Australia and others; LoDoCo2 Australian New Zealand Clinical Trials Registry number, ACTRN12614000093684.).",2020,"A key secondary end-point event occurred in 115 patients (4.2%) in the colchicine group and in 157 patients (5.7%) in the placebo group (incidence, 1.5 vs. 2.1 events per 100 person-years; hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P = 0.007).","['patients with chronic coronary disease to receive 0.5 mg of', 'Patients with Chronic Coronary Disease', 'patients with recent myocardial infarction', 'patients with chronic coronary disease', '5522 patients underwent randomization; 2762']","['colchicine once daily or matching placebo', 'colchicine', 'Colchicine', 'placebo']","['composite of cardiovascular death, spontaneous myocardial infarction, or ischemic stroke', 'incidence of death from noncardiovascular causes', 'risk of cardiovascular events', 'median duration', 'incidence rates of spontaneous myocardial infarction or ischemia-driven coronary revascularization (composite end point), cardiovascular death or spontaneous myocardial infarction (composite end point), ischemia-driven coronary revascularization, and spontaneous myocardial infarction', 'composite of cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0010068', 'cui_str': 'Coronary Heart Disease'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1998297', 'cui_str': 'Recent myocardial infarction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0444930', 'cui_str': 'End'}]",5522.0,0.707454,"A key secondary end-point event occurred in 115 patients (4.2%) in the colchicine group and in 157 patients (5.7%) in the placebo group (incidence, 1.5 vs. 2.1 events per 100 person-years; hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P = 0.007).","[{'ForeName': 'Stefan M', 'Initials': 'SM', 'LastName': 'Nidorf', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Aernoud T L', 'Initials': 'ATL', 'LastName': 'Fiolet', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Arend', 'Initials': 'A', 'LastName': 'Mosterd', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Schut', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Tjerk S J', 'Initials': 'TSJ', 'LastName': 'Opstal', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Salem H K', 'Initials': 'SHK', 'LastName': 'The', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Xiao-Fang', 'Initials': 'XF', 'LastName': 'Xu', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Ireland', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Lenderink', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Latchem', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Hoogslag', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Anastazia', 'Initials': 'A', 'LastName': 'Jerzewski', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nierop', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Whelan', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Hendriks', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Swart', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Schaap', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Aaf F M', 'Initials': 'AFM', 'LastName': 'Kuijper', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Maarten W J', 'Initials': 'MWJ', 'LastName': 'van Hessen', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Pradyot', 'Initials': 'P', 'LastName': 'Saklani', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Tan', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Angus G', 'Initials': 'AG', 'LastName': 'Thompson', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Morton', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Judkins', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'Bax', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Maurits', 'Initials': 'M', 'LastName': 'Dirksen', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Alings', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Graeme J', 'Initials': 'GJ', 'LastName': 'Hankey', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Charley A', 'Initials': 'CA', 'LastName': 'Budgeon', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Cornel', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Thompson', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2021372']
1732,32933995,Concomitant Proton Pump Inhibitor Use and Survival in Urothelial Carcinoma Treated with Atezolizumab.,"PURPOSE


Emerging evidence indicates that gut microbiota dysbiosis can reduce the effectiveness of immune checkpoint inhibitors (ICI). Proton pump inhibitors (PPI) are known to induce gut microbiota changes. However, little is known on the effects of PPIs on outcomes with ICI therapy, and it has not been explored in urothelial cancer treatment.
EXPERIMENTAL DESIGN


Individual-participant data from the advanced urothelial cancer trials, IMvigor210 (single-arm atezolizumab trial,  n  = 429) and IMvigor211 (phase III randomized trial of atezolizumab vs. chemotherapy,  n  = 931) were pooled in a Cox proportional hazard analysis assessing the association between PPI use and overall survival (OS) and progression-free survival (PFS). PPI use was defined as any PPI administration between 30 days prior and 30 days after treatment initiation.
RESULTS


Of the 1,360 participants, 471 (35%) received a PPI within the 60-day window. PPI use was associated with significantly worse OS [HR (95% confidence interval (CI)) = 1.52 (1.27-1.83),  P  < 0.001] and PFS [1.38 (1.18-1.62),  P  < 0.001] with atezolizumab, but not chemotherapy ( P  > 0.05). In the randomized cohort of IMvigor211, the OS treatment effect [HR (95% CI)] of atezolizumab versus chemotherapy was 1.04 (0.81-1.34) for PPI users, compared with 0.69 (0.56-0.84) for PPI nonusers ( P   interaction  = 0.013). Similar associations were noted in the PD-L1 IC2/3 population.
CONCLUSIONS


This study indicates PPI use is a negative prognostic marker in advanced urothelial carcinoma treated with ICI therapy, but not chemotherapy. Furthermore, the analysis suggests PPIs influence the magnitude of ICI efficacy, and this warrants further investigation.",2020,"< 0.001] and PFS [1.38 (1.18-1.62),  P  < 0.001] with atezolizumab, but not chemotherapy ( P  > 0.05).","['Individual-participant data from the advanced urothelial cancer trials, IMvigor210 (single-arm atezolizumab trial,  n  = 429) and', 'Of the 1,360 participants, 471 (35%) received a PPI within the 60-day window', 'advanced urothelial carcinoma treated with']","['Proton pump inhibitors (PPI', 'ICI therapy', 'Atezolizumab', 'atezolizumab vs. chemotherapy', 'IMvigor211', 'atezolizumab']","['ICI efficacy', 'PPI use and overall survival (OS) and progression-free survival (PFS', 'PFS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1360.0,0.143162,"< 0.001] and PFS [1.38 (1.18-1.62),  P  < 0.001] with atezolizumab, but not chemotherapy ( P  > 0.05).","[{'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Hopkins', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia. ashley.hopkins@flinders.edu.au.'}, {'ForeName': 'Ganessan', 'Initials': 'G', 'LastName': 'Kichenadasse', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Karapetis', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rowland', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sorich', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1876']
1733,32934207,Walking after incomplete spinal cord injury with an implanted neuromuscular electrical stimulation system and a hinged knee replacement: a single-subject study.,"STUDY DESIGN


Single-subject repeated measures study.
OBJECTIVES


Neuromuscular electrical stimulation (NMES) can enhance walking for people with partial paralysis from incomplete spinal cord injury (iSCI). This single-subject study documents an individual's experience who both received an experimental implanted NMES system and underwent clinical bilateral hinged total knee arthroplasty (TKA). She walked in the community with knee pain prior to either intervention. Walking performance improved with an implanted NMES system. Knee pain and instability continued to worsen over time and eventually required TKA. This study evaluates the effects of these interventions.
SETTING


Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland OH, USA.
METHODS


The differential and combined effects of NMES and hinged knee replacement were assessed in terms of walking speed, toe clearance, knee angle, and participant perceptions with and without stimulation assistance both before and after TKA.
RESULTS


The combined approach both reduced pain and restored walking ability to levels achieved prior to developing significant knee pain that prevented walking without NMES. There was an interaction effect between NMES and TKA on walking speed. Toe clearance consistently improved with stimulation assistance and TKA prevented significant knee hyperextension. The greatest impact was on endurance. Knee replacement re-enabled long distance walking with the addition of stimulation again more than doubling her maximum walking distance from 214 to 513 m.
CONCLUSIONS


These data support further research of combined implantable interventions that may benefit people with iSCI. Furthermore, joint laxity and pain may not necessarily be contraindications to NMES if addressed with conventional clinical treatments.",2020,The combined approach both reduced pain and restored walking ability to levels achieved prior to developing significant knee pain that prevented walking without NMES.,"['Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland OH, USA', 'people with partial paralysis from incomplete spinal cord injury (iSCI']","['NMES and hinged knee replacement', 'Knee replacement re-enabled long distance walking with the addition of stimulation again more than doubling her maximum walking distance', 'TKA', 'Neuromuscular electrical stimulation (NMES', 'implanted neuromuscular electrical stimulation system and a hinged knee replacement', 'NMES and TKA', 'experimental implanted NMES system and underwent clinical bilateral hinged total knee arthroplasty (TKA']","['walking speed, toe clearance, knee angle, and participant perceptions with and without stimulation assistance', 'Walking performance', 'Toe clearance', 'knee hyperextension', 'Knee pain and instability continued to worsen over time and eventually required TKA', 'walking speed']","[{'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0457406', 'cui_str': 'Hinge'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0336547', 'cui_str': 'Experimental implant'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0546964', 'cui_str': 'Genu recurvatum'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",,0.0562222,The combined approach both reduced pain and restored walking ability to levels achieved prior to developing significant knee pain that prevented walking without NMES.,"[{'ForeName': 'Nathaniel S', 'Initials': 'NS', 'LastName': 'Makowski', 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH, USA. nmakowski@metrohealth.org.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Lombardo', 'Affiliation': 'Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Foglyano', 'Affiliation': 'Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'Kobetic', 'Affiliation': 'Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Pinault', 'Affiliation': 'Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Selkirk', 'Affiliation': 'Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Triolo', 'Affiliation': 'Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH, USA.'}]",Spinal cord series and cases,['10.1038/s41394-020-00336-8']
1734,32965655,"PSO-LONG: Design of a Novel, 12-Month Clinical Trial of Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam in Psoriasis.","BACKGROUND


Psoriasis vulgaris is commonly treated with topical corticosteroids and vitamin D analogues. Although potent and super-potent topical corticosteroids are very effective at clearing psoriasis, with short-term reactive treatment durations, symptoms usually recur after treatment discontinuation, necessitating long-term disease management strategies. A foam formulation of calcipotriol and betamethasone dipropionate (Cal/BD foam), consisting of calcipotriol 50 μg/g and betamethasone dipropionate 0.5 mg/g, is approved for the daily treatment of psoriasis for up to 4 weeks. Here, we describe a clinical trial protocol for evaluating the long-term safety and efficacy of twice-weekly Cal/BD foam as a proactive topical maintenance therapy for plaque psoriasis for up to 52 weeks.
OBJECTIVE


The aim of this trial was to evaluate the safety and efficacy of Cal/BD foam when applied twice weekly for up to 52 weeks as proactive maintenance therapy, with the goal of preventing or delaying disease relapse as long as possible while minimizing adverse effects.
METHODS


Once-daily Cal/BD foam treatment responders from an initial 4-week open-label period were randomized to receive Cal/BD foam or foam vehicle applied to previously cleared plaques twice weekly for up to 52 weeks. In case of relapse, affected subjects in either group received rescue therapy with once-daily Cal/BD foam for 4 weeks on active areas. Thus, the trial (NCT02899962) compared the long-term use of Cal/BD foam in a proactive approach with a conventional, reactive approach.
PLANNED OUTCOMES


Efficacy endpoints included the time to first relapse, the number of relapse-free days, and the number of relapses during the maintenance phase. Safety assessments included adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02899962.",2020,"Safety assessments included adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function.
","['plaque psoriasis for up to 52\xa0weeks', 'in Psoriasis']","['Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam', 'calcipotriol and betamethasone dipropionate (Cal/BD foam), consisting of calcipotriol 50\xa0μg', 'betamethasone dipropionate']","['adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function', 'safety and efficacy', 'time to first relapse, the number of relapse-free days, and the number of relapses']","[{'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0714231,"Safety assessments included adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function.
","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Stein Gold', 'Affiliation': 'Department of Dermatology, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Alonso-Llamazares', 'Affiliation': 'Department of Dermatology, VA Medical Center, Miami, FL, USA.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': 'Department of Dermatology, University Hospital of Nice, Nice, France.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, NIHR Manchester BRC University of Manchester, Manchester, UK.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Tyring', 'Affiliation': 'Department of Dermatology, University of Texas Health Science Center, Houston, TX, USA.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Kircik', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Yamauchi', 'Affiliation': 'Division of Dermatology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA. lebwohl@aol.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-020-01497-6']
1735,32940131,The Effect of One Session Split-Belt Treadmill Training on Gait Adaptation in People With Parkinson's Disease and Freezing of Gait.,"BACKGROUND


Freezing of gait (FOG) in Parkinson's disease (PD) is associated with gait asymmetry and switching difficulty. A split-belt treadmill may potentially address those deficits.
OBJECTIVE


To investigate the immediate and retention effects of one-session split-belt treadmill training (SBT) in contrast to regular tied-belt treadmill training (TBT) on gait asymmetry and adaptation in people with PD and FOG (PD + FOG) and healthy controls (HC). Additionally, to investigate differential effects of 3 SBT protocols and compare different gait adaptation outcomes.
METHODS


PD + FOG (n = 45) and HC (n = 36) were randomized to 1 of 3 SBT groups (belt speeds' ratio 0.75:1; 0.5:1 or changing ratios) or TBT group. Participants were tested at Pre, Post, and Retention after one treadmill training session. Gait asymmetry was measured during a standardized adaptation test on the split-belt treadmill.
RESULTS


SBT proved beneficial for gait adaptation in PD + FOG and HC ( P  < .0001); however, HC improved more. SBT with changing ratios demonstrated significant effects on gait adaptation from Pre to Post in PD + FOG, supported by strong effect sizes ( d  = 1.14) and improvements being retained for 24 hours. Mean step length asymmetry during initial exposure was lower in HC compared with PD + FOG ( P  = .035) and differentiated best between the groups.
CONCLUSIONS


PD + FOG improved gait adaptation after a single SBT session although effects were smaller than in HC. SBT with changing ratios was the most effective to ameliorate gait adaptation in PD + FOG. These promising results warrant future study on whether long-term SBT strengthens adaptation in PD + FOG and has potential to induce a better resilience to FOG. Clinical trial ID: NCT03725215.",2020,"Mean step length asymmetry during initial exposure was lower in HC compared with PD + FOG ( P  = .035) and differentiated best between the groups.
","[""Parkinson's disease (PD"", 'people with PD and FOG (PD + FOG) and healthy controls (HC', ""People With Parkinson's Disease and Freezing of Gait"", 'PD + FOG (n = 45) and HC (n = 36']","['PD + FOG', 'regular tied-belt treadmill training (TBT', 'TBT', 'session split-belt treadmill training (SBT', 'One Session Split-Belt Treadmill Training']","['Gait Adaptation', 'Mean step length asymmetry during initial exposure', 'Gait asymmetry', 'gait adaptation', 'gait adaptation in PD + FOG and HC']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0453920', 'cui_str': 'Tie'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",36.0,0.0330414,"Mean step length asymmetry during initial exposure was lower in HC compared with PD + FOG ( P  = .035) and differentiated best between the groups.
","[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Seuthe', 'Affiliation': 'University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': ""D'Cruz"", 'Affiliation': 'Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Ginis', 'Affiliation': 'Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Jos Steffen', 'Initials': 'JS', 'LastName': 'Becktepe', 'Affiliation': 'University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Burkhard', 'Initials': 'B', 'LastName': 'Weisser', 'Affiliation': 'Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Nieuwboer', 'Affiliation': 'Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schlenstedt', 'Affiliation': 'University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel, Germany.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320953144']
1736,32941098,The precision interventions for severe and/or exacerbation-prone asthma (PrecISE) adaptive platform trial: statistical considerations.,"The Precision Interventions for Severe and/or Exacerbation-prone Asthma (PrecISE) study is an adaptive platform trial designed to investigate novel interventions to severe asthma. The study is conducted under a master protocol and utilizes a crossover design with each participant receiving up to five interventions and at least one placebo. Treatment assignments are based on the patients' biomarker profiles and precision health methods are incorporated into the interim and final analyses. We describe key elements of the PrecISE study including the multistage adaptive enrichment strategy, early stopping of an intervention for futility, power calculations, and the primary analysis strategy.",2020,The Precision Interventions for Severe and/or Exacerbation-prone Asthma (PrecISE) study is an adaptive platform trial designed to investigate novel interventions to severe asthma.,[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.032153,The Precision Interventions for Severe and/or Exacerbation-prone Asthma (PrecISE) study is an adaptive platform trial designed to investigate novel interventions to severe asthma.,"[{'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Ivanova', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'LaVange', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Peters', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Loren C', 'Initials': 'LC', 'LastName': 'Denlinger', 'Affiliation': 'University of Wisconsin, Madison.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Moore', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': 'Vanderbilt University, Nashville, TN.'}, {'ForeName': 'M Alison', 'Initials': 'MA', 'LastName': 'Marquis', 'Affiliation': 'Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Nathan M', 'Initials': 'NM', 'LastName': 'Gotman', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Kosorok', 'Affiliation': 'Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Chalmer', 'Initials': 'C', 'LastName': 'Tomlinson', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Mauger', 'Affiliation': 'Penn State University, Hershey, PA.'}, {'ForeName': 'Steve N', 'Initials': 'SN', 'LastName': 'Georas', 'Affiliation': 'University of Rochester, Rochester, NY.'}, {'ForeName': 'Rosalind J', 'Initials': 'RJ', 'LastName': 'Wright', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Noel', 'Affiliation': 'Division of Lung Diseases, National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Rosner', 'Affiliation': 'University of California, San Diego.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Akuthota', 'Affiliation': 'Asthma and Airway Disease Research Center, University of Arizona, Tucson.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Billheimer', 'Affiliation': 'Asthma and Airway Disease Research Center, University of Arizona, Tucson.'}, {'ForeName': 'Eugene R', 'Initials': 'ER', 'LastName': 'Bleecker', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Cardet', 'Affiliation': 'University of Kansas School of Medicine, Kansas City.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Columbia University, New York, NY.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'DiMango', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Serpil C', 'Initials': 'SC', 'LastName': 'Erzurum', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Fahy', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Merritt L', 'Initials': 'ML', 'LastName': 'Fajt', 'Affiliation': 'Wells Center for Pediatric Research, Indiana University, Indianapolis.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Gaston', 'Affiliation': 'Wells Center for Pediatric Research, Indiana University, Indianapolis.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Holguin', 'Affiliation': 'University of Colorado School of Medicine, Aurora.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'University of California, Davis.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Kenyon', 'Affiliation': 'University of Illinois, Chicago.'}, {'ForeName': 'Jerry A', 'Initials': 'JA', 'LastName': 'Krishnan', 'Affiliation': ""Lurie Children's Hospital, Chicago, IL.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kraft', 'Affiliation': ""Lurie Children's Hospital, Chicago, IL.""}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Liu', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Ngoc P', 'Initials': 'NP', 'LastName': 'Ly', 'Affiliation': 'Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Moy', 'Affiliation': ""Boston Children's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Ross', 'Affiliation': ""UH Rainbow Babies and Children's Hospitals, Cleveland, OH.""}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Smith', 'Affiliation': 'Northwestern University, Chicago, IL.'}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'W Gerald', 'Initials': 'WG', 'LastName': 'Teague', 'Affiliation': 'University of Virginia, Charlottesville.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'University of Chicago, Chicago, IL.'}, {'ForeName': 'Sally E', 'Initials': 'SE', 'LastName': 'Wenzel', 'Affiliation': 'National Jewish Health, Denver, CO, and University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'White', 'Affiliation': 'National Jewish Health, Denver, CO, and University of Colorado School of Medicine, Aurora, CO.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2020.1821705']
1737,32941388,"Pentraxin-3, Troponin T, N-Terminal Pro-B-Type Natriuretic Peptide in Septic Patients.","OBJECTIVE


To investigate the behavior of pentraxin-3 (PTX3), troponin T (hsTnT), N-terminal pro-B type Natriuretic Peptide (NT-proBNP) in sepsis and their relationships with sepsis severity and oxygen transport/utilization impairment.
DESIGN


Retrospective analysis of PTX3, hsTnT, NT-proBNP levels at day 1, 2, and 7 after admission in the intensive care unit in a subset of the Albumin Italian Outcome Sepsis database.
SETTING


Forty Italian intensive care units.
PATIENTS


Nine hundred fifty-eight septic patients enrolled in the randomized clinical trial comparing albumin replacement plus crystalloids and crystalloids alone.
INTERVENTIONS


The patients were divided into sextiles of lactate (marker of severity), ScvO2 (marker of oxygen transport), and fluid balance (marker of therapeutic strategy).
MEASUREMENTS AND MAIN RESULTS


PTX3 and hsTnT were remarkably similar in the two treatment arms, while NT-proBNP was almost double in the albumin treatment group. However, as the distribution of all these biomarkers was similar between control and treatment arms, for the sake of clarity, we analyzed the patients as a single cohort. PTX3 (71.8 [32.9-186.3] ng/mL), hsTnT (50.4 [21.6-133.6] ng/L), and NT-proBNP (4,393 [1,313-13,837] ng/L) were abnormally elevated in 100%, 84.5%, 93.4% of the 953 patients and all decreased from day 1 to day 7. PTX3 monotonically increased with increasing lactate levels. The hsTnT levels were significantly higher when ScvO2 levels were abnormally low (< 70%), suggesting impaired oxygen transport compared with higher ScvO2 levels, suggesting impaired oxygen utilization. NT-proBNP was higher with higher lactate and fluid balance. At ScvO2 levels < 70%, the NT-proBNP was higher than at higher ScvO2 levels. However, even with higher ScvO2, the NT-proBNP was remarkably elevated, suggesting volume expansion. Increased level of NT-proBNP showed the strongest association with 90-day mortality.
CONCLUSIONS


The selected biomarkers seem related to different mechanisms during sepsis: PTX3 to sepsis severity, hsTnT to impaired oxygen transport, NT-proBNP to sepsis severity, oxygen transport, and aggressive fluid strategy.",2020,"At ScvO2 levels < 70%, the NT-proBNP was higher than at higher ScvO2 levels.","[' 40 Italian intensive care units', 'septic patients', '958 septic patients enrolled']","['PTX3', 'pentraxin-3 (PTX3), troponin T (hsTnT), N-terminal pro-B type Natriuretic Peptide (NT-proBNP', 'albumin replacement plus crystalloids and crystalloids alone', 'sextiles of lactate (marker of severity), ScvO2 (marker of oxygen transport) and fluid balance (marker of therapeutic strategy']","['Increased level of NT-proBNP', 'NT-proBNP', 'lactate levels', 'ScvO2 levels']","[{'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0174234', 'cui_str': 'PTX3 protein'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}]",,0.119829,"At ScvO2 levels < 70%, the NT-proBNP was higher than at higher ScvO2 levels.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Vassalli', 'Affiliation': 'Department of Anaesthesiology, Emergency, and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Masson', 'Affiliation': 'Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Meessen', 'Affiliation': 'Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Pasticci', 'Affiliation': 'Department of Anaesthesiology, Emergency, and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bonifazi', 'Affiliation': 'Department of Anaesthesiology, Emergency, and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Vivona', 'Affiliation': 'Department of Pathophysiology and Transplantation, University of Milan, Milan (MI), Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Caironi', 'Affiliation': 'Department of Anesthesia and Critical Care, Azienda Ospedaliero-Universitaria S. Luigi Gonzaga, Orbassano (TO), Italy.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Busana', 'Affiliation': 'Department of Anaesthesiology, Emergency, and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Giosa', 'Affiliation': 'Department of Anaesthesiology, Emergency, and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Matteo Maria', 'Initials': 'MM', 'LastName': 'Macrì', 'Affiliation': 'Department of Anaesthesiology, Emergency, and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Romitti', 'Affiliation': 'Department of Anaesthesiology, Emergency, and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Novelli', 'Affiliation': 'Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Quintel', 'Affiliation': 'Department of Anaesthesiology, Emergency, and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Latini', 'Affiliation': 'Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Gattinoni', 'Affiliation': 'Department of Anaesthesiology, Emergency, and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.'}]","Shock (Augusta, Ga.)",['10.1097/SHK.0000000000001543']
1738,32941801,Activate: Randomized Clinical Trial of BCG Vaccination against Infection in the Elderly.,"BCG vaccination in children protects against heterologous infections and improves survival independently of tuberculosis prevention. The phase III ACTIVATE trial assessed whether BCG has similar effects in the elderly. In this double-blind, randomized trial, elderly patients (n = 198) received BCG or placebo vaccine at hospital discharge and were followed for 12 months for new infections. At interim analysis, BCG vaccination significantly increased the time to first infection (median 16 weeks compared to 11 weeks after placebo). The incidence of new infections was 42.3% (95% CIs 31.9%-53.4%) after placebo vaccination and 25.0% (95% CIs 16.4%-36.1%) after BCG vaccination; most of the protection was against respiratory tract infections of probable viral origin (hazard ratio 0.21, p = 0.013). No difference in the frequency of adverse effects was found. Data show that BCG vaccination is safe and can protect the elderly against infections. Larger studies are needed to assess protection against respiratory infections, including COVID-19 (ClinicalTrials.gov NCT03296423).",2020,"At interim analysis, BCG vaccination significantly increased the time to first infection (median 16 weeks compared to 11 weeks after placebo).","['elderly patients (n\xa0= 198) received', 'Elderly']","['BCG', 'BCG vaccination', 'Activate', 'BCG or placebo vaccine']","['frequency of adverse effects', 'incidence of new infections', 'time to first infection']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0199804', 'cui_str': 'BCG vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439633', 'cui_str': 'New infection'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.444856,"At interim analysis, BCG vaccination significantly increased the time to first infection (median 16 weeks compared to 11 weeks after placebo).","[{'ForeName': 'Evangelos J', 'Initials': 'EJ', 'LastName': 'Giamarellos-Bourboulis', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece. Electronic address: egiamarel@med.uoa.gr.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsilika', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Moorlag', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Antonakos', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Antigone', 'Initials': 'A', 'LastName': 'Kotsaki', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Domínguez-Andrés', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.'}, {'ForeName': 'Evdoxia', 'Initials': 'E', 'LastName': 'Kyriazopoulou', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Theologia', 'Initials': 'T', 'LastName': 'Gkavogianni', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Maria-Evangelia', 'Initials': 'ME', 'LastName': 'Adami', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Damoraki', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Koufargyris', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Athanassios', 'Initials': 'A', 'LastName': 'Karageorgos', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Bolanou', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Koenen', 'Affiliation': 'Department of Laboratory Medicine, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.'}, {'ForeName': 'Reinout', 'Initials': 'R', 'LastName': 'van Crevel', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.'}, {'ForeName': 'Dionyssia-Irene', 'Initials': 'DI', 'LastName': 'Droggiti', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Renieris', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Papadopoulos', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands; Department of Immunology and Metabolism, Life & Medical Sciences Institute, University of Bonn, 53115 Bonn, Germany.'}]",Cell,['10.1016/j.cell.2020.08.051']
1739,32942192,Cluster randomized controlled trial (RCT) to support parental contact for children in out-of-home care.,"BACKGROUND


There is an identified need to improve the evidence-base in relation to contact visits for children in the out-of-home-care (OOHC) system, to ensure optimal outcomes.
OBJECTIVE


The aim of this cluster randomized controlled trial (RCT) was to test the effectiveness of a contact intervention for parents having supervised contact with children in long-term OOHC.
PARTICIPANTS


183 study children in 15 clusters (OOHC services) and their parent(s) were randomized to the intervention (8 clusters, 100 children) and control groups (7 clusters, 83 children) in three Australian jurisdictions.
SETTING


The manualized intervention consisted of increasing the preparation and support provided by caseworkers to parents before and after their contact visits.
METHOD


Interviews were conducted with carers, parents and caseworkers of the study children at baseline and nine months post-randomization. Interviews included standardized assessment tools measuring child and adult wellbeing and relationships, carer and caseworker ability to support contact, and contact visit cancellations by the parent.
RESULTS


Compared with controls, the intention-to-treat (ITT) analyses showed that fewer visits were cancelled by parents in the intervention group at follow-up (-10.27; 95 % CI: -17.04 to -3.50, p = .006). In addition, per-protocol (PP) analyses showed higher caseworker receptivity to contact (6.03; 95 % CI: 0.04-12.03, p = .04), and higher parent satisfaction with contact (7.41; 95 % CI: 0.70-14.11, p = .03) in the intervention group at follow-up.
CONCLUSIONS


While the intervention did not have an effect on child wellbeing, as measured by the SDQ, the trial reports significant positive findings and demonstrates the benefits of the kC kContact intervention in providing support to parents to attend contact visits. The findings of the current study provide an important contribution to knowledge in an area where few RCTs have been completed, notwithstanding the null findings.",2020,"While the intervention did not have an effect on child wellbeing, as measured by the SDQ, the trial reports significant positive findings and demonstrates the benefits of the kC kContact intervention in providing support to parents to attend contact visits.","['parents having supervised contact with children in long-term OOHC', 'children in out-of-home care', 'Interviews were conducted with carers, parents and caseworkers of the study children at baseline and nine months post-randomization', '183 study children in 15 clusters (OOHC services) and their parent(s']","['kC kContact intervention', 'contact intervention']","['standardized assessment tools measuring child and adult wellbeing and relationships, carer and caseworker ability to support contact, and contact visit cancellations by the parent', 'caseworker receptivity', 'child wellbeing']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0019855', 'cui_str': 'Services, Home Care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",183.0,0.11973,"While the intervention did not have an effect on child wellbeing, as measured by the SDQ, the trial reports significant positive findings and demonstrates the benefits of the kC kContact intervention in providing support to parents to attend contact visits.","[{'ForeName': 'Aino', 'Initials': 'A', 'LastName': 'Suomi', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia; Research School of Population Health, The Australian National University, Australia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Lucas', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia.'}, {'ForeName': 'Morag', 'Initials': 'M', 'LastName': 'McArthur', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Humphreys', 'Affiliation': 'Department of Social Work, The University of Melbourne, Australia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Dobbins', 'Affiliation': 'School of Public Health and Community Medicine, The University of New South Wales, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Taplin', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia. Electronic address: stephanie.taplin@acu.edu.au.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104708']
1740,32946821,Effect of dapagliflozin as an adjunct to insulin over 52 weeks in individuals with type 1 diabetes: post-hoc renal analysis of the DEPICT randomised controlled trials.,"BACKGROUND


The DEPICT-1 and DEPICT-2 studies showed that dapagliflozin as an adjunct to insulin in individuals with inadequately controlled type 1 diabetes improved glycaemic control and bodyweight, without increase in risk of hypoglycaemia. We aimed to determine the effect of dapagliflozin on urinary albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) using pooled data from the DEPICT studies.
METHODS


In this post-hoc analysis, we used data pooled from both DEPICT studies (DEPICT-1 ran from Nov 11, 2014, to Aug 25, 2017; DEPICT-2 ran from July 8, 2015, to April 18, 2018), in which participants were aged 18-75 years, with inadequately controlled type 1 diabetes and with a baseline UACR of at least 30 mg/g. In the DEPICT studies, participants were randomly assigned (1:1:1) to receive dapagliflozin (5 mg or 10 mg) or placebo all plus insulin, for 24 weeks, with a 28-week long-term extension (ie, 52 weeks in total). In this post-hoc analysis, we assessed the percentage change from baseline in UACR and in eGFR, up to 52 weeks. UACR, eGFR, and safety were assessed in all eligible participants who had received at least one dose of study drug. HbA 1c , bodyweight, and systolic blood pressure were assessed in all participants who received at least one dose of study drug during the first 24-week period, and who had a baseline and any post-baseline assessment for that parameter. The DEPICT trials were registered with ClinicalTrials.gov, NCT02268214 (DEPICT-1), NCT02460978 (DEPICT-2), and are now complete.
RESULTS


251 participants with albuminuria at baseline were included in this post-hoc analysis; of whom 80 (32%) had been randomly assigned to dapagliflozin 5 mg, 84 (33%) to dapagliflozin 10 mg, and 87 (35%) to placebo. Compared with placebo, treatment with both dapagliflozin doses improved UACR over 52 weeks. At week 52, mean difference in change from baseline versus placebo in UACR was -13·3% (95% CI -37·2 to 19·8) for dapagliflozin 5 mg and -31·1% (-49·9 to -5·2) for dapagliflozin 10 mg. No notable change from baseline was seen in eGFR, with a mean difference in change from baseline versus placebo of 3·27 mL/min per 1·73 m 2  (95% CI -0·92 to 7·45) for dapagliflozin 5 mg and 2·12 mL/min per 1·73 m 2  (-2·03 to 6·27) for dapagliflozin 10 mg. Similar proportions of participants in each treatment group had adverse events and serious adverse events, including hypoglycaemia and diabetic ketoacidosis; no new safety signals were identified in this population.
INTERPRETATION


Treatment with dapagliflozin resulted in UACR reduction, which might provide renoprotective benefits in individuals with type 1 diabetes and albuminuria. Dedicated prospective studies are needed to confirm these findings as prespecified endpoints.
FUNDING


AstraZeneca.",2020,"Similar proportions of participants in each treatment group had adverse events and serious adverse events, including hypoglycaemia and diabetic ketoacidosis; no new safety signals were identified in this population.
","['individuals with inadequately controlled type 1 diabetes', 'eligible participants who had received at least one dose of study drug', '251 participants with albuminuria at baseline were included in this post-hoc analysis; of whom 80 (32', 'individuals with type 1 diabetes and albuminuria', 'participants were aged 18-75 years, with inadequately controlled type 1 diabetes and with a baseline UACR of at least 30 mg/g', 'individuals with type 1 diabetes']","['placebo', 'placebo all plus insulin', 'dapagliflozin']","['urinary albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR', 'HbA 1c , bodyweight, and systolic blood pressure', 'UACR', 'UACR reduction', 'hypoglycaemia and diabetic ketoacidosis; no new safety signals', 'adverse events and serious adverse events', 'UACR, eGFR, and safety']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",251.0,0.625792,"Similar proportions of participants in each treatment group had adverse events and serious adverse events, including hypoglycaemia and diabetic ketoacidosis; no new safety signals were identified in this population.
","[{'ForeName': 'Per-Henrik', 'Initials': 'PH', 'LastName': 'Groop', 'Affiliation': 'Abdominal Center, Nephrology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Helsinki, Finland; Folkhälsan Institute of Genetics, Folkhälsan Research Center, Biomedicum Helsinki, Helsinki, Finland; Department of Diabetes, Central Clinical School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Paresh', 'Initials': 'P', 'LastName': 'Dandona', 'Affiliation': 'Jacob School of Medicine, State University of New York, Buffalo, NY, USA.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Phillip', 'Affiliation': ""Institute for Endocrinology and Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Gillard', 'Affiliation': 'Clinical and Experimental Endocrinology, UZ Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Edelman', 'Affiliation': 'Department of Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Jendle', 'Affiliation': 'Institute of Medical Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Late-stage Development, Cardiovascular, Renal and Metabolism, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Markus F', 'Initials': 'MF', 'LastName': 'Scheerer', 'Affiliation': 'BioParmaceuticals Medical, AstraZeneca, Wedel, Germany.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Thoren', 'Affiliation': 'Late-stage Development Cardiovascular, Renal and Metabolism, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'Late-stage Development, Cardiovascular, Renal and Metabolism, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Repetto', 'Affiliation': 'Global Medical Affairs, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Mathieu', 'Affiliation': 'Clinical and Experimental Endocrinology, UZ Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium. Electronic address: chantal.mathieu@uzleuven.be.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30280-1']
1741,32946820,"Metformin in women with type 2 diabetes in pregnancy (MiTy): a multicentre, international, randomised, placebo-controlled trial.","BACKGROUND


Although metformin is increasingly being used in women with type 2 diabetes during pregnancy, little data exist on the benefits and harms of metformin use on pregnancy outcomes in these women. We aimed to investigate the effects of the addition of metformin to a standard regimen of insulin on neonatal morbidity and mortality in pregnant women with type 2 diabetes.
METHODS


In this prospective, multicentre, international, randomised, parallel, double-masked, placebo-controlled trial, women with type 2 diabetes during pregnancy were randomly assigned from 25 centres in Canada and four in Australia to receive either metformin 1000 mg twice daily or placebo, added to insulin. Randomisation was done via a web-based computerised randomisation service and stratified by centre and pre-pregnancy BMI (<30 kg/m 2  or ≥30 kg/m 2 ) in a ratio of 1:1 using random block sizes of 4 and 6. Women were eligible if they had type 2 diabetes, were on insulin, had a singleton viable pregnancy, and were between 6 and 22 weeks plus 6 days' gestation. Participants were asked to check their fasting blood glucose level before the first meal of the day, before the last meal of the day, and 2 h after each meal. Insulin doses were adjusted aiming for identical glucose targets (fasting glucose <5·3 mmol/L [95 mg/dL], 2-h postprandial glucose <6·7 mmol/L [120 mg/dL]). Study visits were done monthly and patients were seen every 1-4 weeks as was needed for standard clinical care. At study visits blood pressure and bodyweight were measured; patients were asked about tolerance to their pills, any hospitalisations, insulin doses, and severe hypoglycaemia events; and glucometer readings were downloaded to the central coordinating centre. Participants, caregivers, and outcome assessors were masked to the intervention. The primary outcome was a composite of fetal and neonatal outcomes, for which we calculated the relative risk and 95% CI between groups, stratifying by site and BMI using a log-binomial regression model with an intention-to-treat analysis. Secondary outcomes included several relevant maternal and neonatal outcomes. The trial was registered with ClinicalTrials.gov, NCT01353391.
FINDINGS


Between May 25, 2011, and Oct 11, 2018, we randomly assigned 502 women, 253 (50%) to metformin and 249 (50%) to placebo. Complete data were available for 233 (92%) participants in the metformin group and 240 (96%) in the placebo group for the primary outcome. We found no significant difference in the primary composite neonatal outcome between the two groups (40% vs 40%; p=0·86; relative risk [RR] 1·02 [0·83 to 1·26]). Compared with women in the placebo group, metformin-treated women achieved better glycaemic control (HbA 1c  at 34 weeks' gestation 41·0 mmol/mol [SD 8·5] vs 43·2 mmol/mol [-10]; 5·90% vs 6·10%; p=0·015; mean glucose 6·05 [0·93] vs 6·27 [0·90]; difference -0·2 [-0·4 to 0·0]), required less insulin (1·1 units per kg per day vs 1·5 units per kg per day; difference -0·4 [95% CI -0·5 to -0·2]; p<0·0001), gained less weight (7·2 kg vs 9·0 kg; difference -1·8 [-2·7 to -0·9]; p<0·0001) and had fewer caesarean births (125 [53%] of 234 in the metformin group vs 148 [63%] of 236 in the placebo group; relative risk [RR] 0·85 [95% CI 0·73 to 0·99]; p=0·031). We found no significant difference between the groups in hypertensive disorders (55 [23%] in the metformin group vs 56 [23%] in the placebo group; p=0·93; RR 0·99 [0·72 to 1·35]). Compared with those in the placebo group, metformin-exposed infants weighed less (mean birthweight 3156 g [SD 742] vs 3375 g [742]; difference -218 [-353 to -82]; p=0·002), fewer were above the 97th centile for birthweight (20 [9%] in the metformin group vs 34 [15%] in the placebo group; RR 0·58 [0·34 to 0·97]; p=0·041), fewer weighed 4000 g or more at birth (28 [12%] in the metformin group vs 44 [19%] in the placebo group; RR 0·65 [0·43 to 0·99]; p=0·046), and metformin-exposed infants had reduced adiposity measures (mean sum of skinfolds 16·0 mm [SD 5·0] vs 17·4 [6·2] mm; difference -1·41 [-2·6 to -0·2]; p=0·024; mean neonatal fat mass 13·2 [SD 6·2] vs 14·6 [5·0]; p=0·017). 30 (13%) infants in the metformin group and 15 (7%) in the placebo group were small for gestational age (RR 1·96 [1·10 to 3·64]; p=0·026). We found no significant difference in the cord c-peptide between groups (673 pmol/L [435] in the metformin group vs 758 pmol/L [595] in the placebo group; p=0·10; ratio of means 0·88 [0·72 to 1·02]). The most common adverse event reported was gastrointestinal (38 events in the metformin group and 38 events in the placebo group).
INTERPRETATION


We found several maternal glycaemic and neonatal adiposity benefits in the metformin group. Along with reduced maternal weight gain and insulin dosage and improved glycaemic control, the lower adiposity and infant size measurements resulted in fewer large infants but a higher proportion of small-for-gestational-age infants. Understanding the implications of these effects on infants will be important to properly advise patients who are contemplating the use of metformin during pregnancy.
FUNDING


Canadian Institutes of Health Research, Lunenfeld-Tanenbaum Research Institute, University of Toronto.",2020,"The most common adverse event reported was gastrointestinal (38 events in the metformin group and 38 events in the placebo group).
","['0·85', 'women with type 2 diabetes during pregnancy', 'pregnant women with type 2 diabetes', 'group; RR 0·58', 'women with type 2 diabetes in pregnancy (MiTy', '0·34 to 0·97', 'women with type 2 diabetes during pregnancy were randomly assigned from 25 centres in Canada and four in Australia to receive either', 'group were small for gestational age (RR 1·96', ""Women were eligible if they had type 2 diabetes, were on insulin, had a singleton viable pregnancy, and were between 6 and 22 weeks plus 6 days' gestation""]","['insulin', 'metformin', 'placebo', 'metformin 1000 mg twice daily or placebo, added to insulin', 'Metformin']","['relative risk [RR', 'maternal weight gain and insulin dosage and improved glycaemic control, the lower adiposity and infant size measurements', 'composite of fetal and neonatal outcomes', 'adiposity measures', 'hypertensive disorders', 'neonatal morbidity and mortality', 'several relevant maternal and neonatal outcomes', 'fasting blood glucose level', 'several maternal glycaemic and neonatal adiposity benefits', 'mean neonatal fat mass 13·2', 'caesarean births', 'glycaemic control', '2-h postprandial glucose']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0404843', 'cui_str': 'Viable pregnancy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",502.0,0.606777,"The most common adverse event reported was gastrointestinal (38 events in the metformin group and 38 events in the placebo group).
","[{'ForeName': 'Denice S', 'Initials': 'DS', 'LastName': 'Feig', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada; Lunenfeld-Tanenbaum Research Institute, Toronto, ON, Canada; Sinai Health System, Mount Sinai Hospital, Toronto, ON, Canada. Electronic address: d.feig@utoronto.ca.'}, {'ForeName': 'Lois E', 'Initials': 'LE', 'LastName': 'Donovan', 'Affiliation': ""Cumming School of Medicine, Department of Medicine, Department of Obstetrics and Gynecology, University of Calgary, Calgary, AB, Canada; Alberta Children's Hospital Research Institute, Calgary, AB, Canada.""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada; Lunenfeld-Tanenbaum Research Institute, Toronto, ON, Canada; Sinai Health System, Mount Sinai Hospital, Toronto, ON, Canada.'}, {'ForeName': 'J Johanna', 'Initials': 'JJ', 'LastName': 'Sanchez', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Asztalos', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Edmond A', 'Initials': 'EA', 'LastName': 'Ryan', 'Affiliation': 'University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'I George', 'Initials': 'IG', 'LastName': 'Fantus', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada; Lunenfeld-Tanenbaum Research Institute, Toronto, ON, Canada; Sinai Health System, Mount Sinai Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Hutton', 'Affiliation': 'McMaster University Hamilton, ON, Canada.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'Armson', 'Affiliation': 'Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Lorraine L', 'Initials': 'LL', 'LastName': 'Lipscombe', 'Affiliation': ""Department of Medicine, University of Toronto, Toronto, ON, Canada; Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simmons', 'Affiliation': 'Western Sydney University, Sydney, NSW, Australia.'}, {'ForeName': 'Jon F R', 'Initials': 'JFR', 'LastName': 'Barrett', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada; Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Karanicolas', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada; Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Tobin', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'H David', 'Initials': 'HD', 'LastName': 'McIntyre', 'Affiliation': 'Mater Research, University of Queensland, South Brisbane, QLD, Australia.'}, {'ForeName': 'Simon Yu', 'Initials': 'SY', 'LastName': 'Tian', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tomlinson', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada; Department of Medicine, University Health, Network, Toronto, ON, Canada.'}, {'ForeName': 'Kellie E', 'Initials': 'KE', 'LastName': 'Murphy', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada; Lunenfeld-Tanenbaum Research Institute, Toronto, ON, Canada; Sinai Health System, Mount Sinai Hospital, Toronto, ON, Canada; Department of Obstetrics and Gynecology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30310-7']
1742,32947474,A Randomized Controlled Trial of Antithrombin Supplementation During Extracorporeal Membrane Oxygenation.,"OBJECTIVES


Supplementation of antithrombin might decrease the amount of heparin needed to achieve a given anticoagulation target during extracorporeal membrane oxygenation. However, exogenous antithrombin itself may increase the risk of bleeding. We conceived a study to evaluate the effect of antithrombin supplementation in adult patients requiring venovenous extracorporeal membrane oxygenation for respiratory failure on heparin dose, adequacy of anticoagulation, and safety.
DESIGN


Prospective randomized controlled trial.
SETTING


ICUs of two Italian referral extracorporeal membrane oxygenation centers.
PATIENTS


Adult patients requiring venovenous extracorporeal membrane oxygenation for severe respiratory failure and unfractionated heparin for systemic anticoagulation.
INTERVENTIONS


Before extracorporeal membrane oxygenation start, patients were randomized to either receive antithrombin concentrate to maintain a plasmatic level 80-120% (treatment) or not (control) during the extracorporeal membrane oxygenation course.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was the total amount of heparin required to maintain activated partial thromboplastin time ratio 1.5-2. Secondary outcomes were anti-factor Xa, the incidence of hemorrhagic and thrombotic events, and the amount of blood products transfused. Twenty-four patients in the treatment group and 24 in the control group were included in the intention-to-treat analysis. Antithrombin was 109.5% (93.0-123.0%) in the treatment group and 84.0% (68.5-98.0%) in the control group (p = 0.001). Supplementation of antithrombin did not decrease heparin dose (13.5 international units/kg/hr [9.6-17.9 international units/kg/hr] vs 15.1 international units/kg/hr [10.7-18.3 international units/kg/hr] in the treatment and control group, respectively; p = 0.33) and anti-Factor Xa levels (0.4 international units/mL [0.3-0.5 international units/mL] vs 0.3 international units/mL [0.2-0.5 international units/mL] in the treatment group and control group respectively; p = 0.65). Bleeding, blood product transfusions, and thrombosis were not different in the two groups.
CONCLUSIONS


Antithrombin supplementation may not decrease heparin requirement nor diminish the incidence of bleeding and/or thrombosis in adult patients on venovenous extracorporeal membrane oxygenation.",2020,Antithrombin was 109.5% (93.0-123.0%) in the treatment group and 84.0% (68.5-98.0%) in the control group (p = 0.001).,"['adult patients on venovenous extracorporeal membrane oxygenation', 'adult patients requiring venovenous extracorporeal membrane oxygenation for respiratory failure', 'ICUs of two Italian referral extracorporeal membrane oxygenation centers', 'Twenty-four patients in the treatment group and 24 in the control group were included in the intention-to-treat analysis', 'Adult patients requiring', 'for severe respiratory failure and unfractionated heparin for systemic anticoagulation']","['venovenous extracorporeal membrane oxygenation', 'Antithrombin supplementation', 'antithrombin concentrate to maintain a plasmatic level 80-120% (treatment) or not (control) during the extracorporeal membrane oxygenation course', 'Antithrombin Supplementation', 'antithrombin supplementation', 'antithrombin']","['Antithrombin', 'anti-Factor Xa levels', 'risk of bleeding', 'bleeding and/or thrombosis', 'heparin dose, adequacy of anticoagulation, and safety', 'total amount of heparin required to maintain activated partial thromboplastin time ratio 1.5-2', 'anti-factor Xa, the incidence of hemorrhagic and thrombotic events, and the amount of blood products transfused', 'Bleeding, blood product transfusions, and thrombosis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5192099', 'cui_str': 'Venovenous extracorporeal membrane oxygenation'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]","[{'cui': 'C5192099', 'cui_str': 'Venovenous extracorporeal membrane oxygenation'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0427612', 'cui_str': 'Anti factor Xa measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1272061', 'cui_str': 'Activated partial thromboplastin time ratio'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0443793', 'cui_str': 'Anti factor Xa'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0456388', 'cui_str': 'Blood product'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",,0.267968,Antithrombin was 109.5% (93.0-123.0%) in the treatment group and 84.0% (68.5-98.0%) in the control group (p = 0.001).,"[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Panigada', 'Affiliation': 'Department of Anaesthesia and Critical Care, ""Fondazione IRCCS Ca\' Granda, Ospedale Maggiore Policlinico,"" Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Cucino', 'Affiliation': 'Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Spinelli', 'Affiliation': 'Department of Anaesthesia and Critical Care, ""Fondazione IRCCS Ca\' Granda, Ospedale Maggiore Policlinico,"" Milan, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Occhipinti', 'Affiliation': 'Department of Anesthesiology and Intensive Care, ISMETT IRCCS (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione), UPMC, Palermo, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Panarello', 'Affiliation': 'Department of Anesthesiology and Intensive Care, ISMETT IRCCS (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione), UPMC, Palermo, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Novembrino', 'Affiliation': ""Clinical Laboratory, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Consonni', 'Affiliation': ""Epidemiology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Protti', 'Affiliation': 'Department of Anesthesia and Intensive Care, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Lissoni', 'Affiliation': 'Department of Anaesthesia and Critical Care, ""Fondazione IRCCS Ca\' Granda, Ospedale Maggiore Policlinico,"" Milan, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Arcadipane', 'Affiliation': 'Department of Anesthesiology and Intensive Care, ISMETT IRCCS (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione), UPMC, Palermo, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': 'Department of Anaesthesia and Critical Care, ""Fondazione IRCCS Ca\' Granda, Ospedale Maggiore Policlinico,"" Milan, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Grasselli', 'Affiliation': 'Department of Anaesthesia and Critical Care, ""Fondazione IRCCS Ca\' Granda, Ospedale Maggiore Policlinico,"" Milan, Italy.'}]",Critical care medicine,['10.1097/CCM.0000000000004590']
1743,32947480,"The 11th Trial of a Cardiovascular Clinical Trialist - Coronavirus-2, Part 3.",,2020,,[],[],[],[],[],[],,0.0214642,,"[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Frishman', 'Affiliation': 'Department of Medicine, New York Medical College/Westchester Medical Center, Valhalla, NY.'}]",Cardiology in review,['10.1097/CRD.0000000000000349']
1744,32947920,"The Influence of Cyclical Ketogenic Reduction Diet vs. Nutritionally Balanced Reduction Diet on Body Composition, Strength, and Endurance Performance in Healthy Young Males: A Randomized Controlled Trial.","(1) Background: The influence of ketogenic diet on physical fitness remains controversial. We performed a randomized controlled trial to compare the effect of cyclical ketogenic reduction diet (CKD) vs. nutritionally balanced reduction diet (RD) on body composition, muscle strength, and endurance performance. (2) Methods: 25 healthy young males undergoing regular resistance training combined with aerobic training were randomized to CKD ( n  = 13) or RD ( n  = 12). Body composition, muscle strength and spiroergometric parameters were measured at baseline and after eight weeks of intervention. (3) Results: Both CKD and RD decreased body weight, body fat, and BMI. Lean body mass and body water decreased in CKD and did not significantly change in RD group. Muscle strength parameters were not affected in CKD while in RD group lat pull-down and leg press values increased. Similarly, endurance performance was not changed in CKD group while in RD group peak workload and peak oxygen uptake increased. (4) Conclusions: Our data show that in healthy young males undergoing resistance and aerobic training comparable weight reduction were achieved by CKD and RD. In RD group; improved muscle strength and endurance performance was noted relative to neutral effect of CKD that also slightly reduced lean body mass.",2020,Muscle strength parameters were not affected in CKD while in RD group lat pull-down and leg press values increased.,"['25 healthy young males undergoing', 'Healthy Young Males', 'healthy young males']","['Cyclical Ketogenic Reduction Diet vs. Nutritionally Balanced Reduction Diet', 'regular resistance training combined with aerobic training', 'cyclical ketogenic reduction diet (CKD) vs. nutritionally balanced reduction diet (RD', 'ketogenic diet', 'CKD']","['Body Composition, Strength, and Endurance Performance', 'Body composition, muscle strength and spiroergometric parameters', 'peak workload and peak oxygen uptake', 'lean body mass', 'Muscle strength parameters', 'weight reduction', 'endurance performance', 'muscle strength and endurance performance', 'body composition, muscle strength, and endurance performance', 'Lean body mass and body water decreased in CKD', 'body weight, body fat, and BMI']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005909', 'cui_str': 'Body water'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",25.0,0.026568,Muscle strength parameters were not affected in CKD while in RD group lat pull-down and leg press values increased.,"[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Kysel', 'Affiliation': 'Department of Sports Medicine, First Faculty of Medicine and General University Hospital, 12000 Prague, Czech Republic.'}, {'ForeName': 'Denisa', 'Initials': 'D', 'LastName': 'Haluzíková', 'Affiliation': 'Department of Sports Medicine, First Faculty of Medicine and General University Hospital, 12000 Prague, Czech Republic.'}, {'ForeName': 'Radka Petráková', 'Initials': 'RP', 'LastName': 'Doležalová', 'Affiliation': 'Department of Sports Medicine, First Faculty of Medicine and General University Hospital, 12000 Prague, Czech Republic.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Laňková', 'Affiliation': 'Centre for Experimental Medicine, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Zdeňka', 'Initials': 'Z', 'LastName': 'Lacinová', 'Affiliation': 'Centre for Experimental Medicine, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Barbora Judita', 'Initials': 'BJ', 'LastName': 'Kasperová', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Jaroslava', 'Initials': 'J', 'LastName': 'Trnovská', 'Affiliation': 'Centre for Experimental Medicine, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Viktorie', 'Initials': 'V', 'LastName': 'Hrádková', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Miloš', 'Initials': 'M', 'LastName': 'Mráz', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Zdeněk', 'Initials': 'Z', 'LastName': 'Vilikus', 'Affiliation': 'Department of Sports Medicine, First Faculty of Medicine and General University Hospital, 12000 Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Haluzík', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}]",Nutrients,['10.3390/nu12092832']
1745,32949505,Effect of permanent right internal mammary artery occlusion on right coronary artery supply: A randomized placebo-controlled clinical trial.,"Natural, nonsurgical internal mammary artery (IMA) bypasses to the coronary circulation have been shown to function as extracardiac sources of myocardial blood supply. The goal of this randomized, placebo-controlled, double-blind trial was to test the efficacy of permanent right IMA (RIMA) device occlusion on right coronary artery (RCA) occlusive blood supply and on clinical and electrocardiographic (ECG) signs of myocardial ischemia.
METHODS


This was a prospective superiority trial in 100 patients with chronic coronary artery disease randomly allocated (1:1) to RIMA vascular device occlusion (verum group) or to RIMA sham procedure (placebo group). The primary study end point was RCA collateral flow index (CFI) as obtained during a 1-minute ostial RCA balloon occlusion at baseline before and at follow-up examination 6 weeks after the trial intervention. CFI is the ratio between simultaneous mean coronary occlusive divided by mean aortic pressure both subtracted by central venous pressure. Simultaneously obtained secondary study end points were the registration of angina pectoris and quantitative intracoronary ECG ST-segment shift.
RESULTS


CFI change during the follow-up period was +0.036 ± 0.068 in the verum group and -0.021 ± 0.097 in the placebo group (P = .0011). Angina pectoris during the same RCA balloon occlusions had disappeared at follow-up in 14/49 patients of the verum group and in 4/49 patients of the placebo group (P = .0091). Simultaneous intracoronary ECG ST-segment shift change revealed diminished myocardial ischemia at follow-up in the verum group and more severe ischemia in the placebo group.
CONCLUSIONS


Permanent RIMA device occlusion augments RCA supply to the effect of diminishing clinical and electrocardiographic signs of myocardial ischemia during a brief controlled coronary occlusion.",2020,"ECG ST-segment shift change revealed diminished myocardial ischemia at follow-up in the verum group, and more severe ischemia in the placebo group.
",['100 patients with chronic coronary artery disease (CAD) randomly allocated (1:1) to'],"['permanent right internal mammary artery occlusion', 'permanent right IMA (RIMA) device occlusion', 'placebo', 'RIMA vascular device occlusion (verum group) or to RIMA sham procedure (placebo', 'CFI']","['right coronary artery supply', 'registration of angina pectoris and quantitative intracoronary (i.c', 'myocardial ischemia', 'Angina pectoris', 'RCA collateral flow index (CFI) as obtained during a 1-minute ostial RCA balloon occlusion', 'CFI change', 'severe ischemia']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0500531', 'cui_str': 'Right internal mammary artery'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C1608397', 'cui_str': 'Device occlusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4552248', 'cui_str': 'Vascular device occlusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1275670', 'cui_str': 'Collateral branch of vessel'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C1261316', 'cui_str': 'Right coronary artery structure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1275670', 'cui_str': 'Collateral branch of vessel'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]",100.0,0.210404,"ECG ST-segment shift change revealed diminished myocardial ischemia at follow-up in the verum group, and more severe ischemia in the placebo group.
","[{'ForeName': 'Marius R', 'Initials': 'MR', 'LastName': 'Bigler', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stoller', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tschannen', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Grossenbacher', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Seiler', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland. Electronic address: christian.seiler@insel.ch.'}]",American heart journal,['10.1016/j.ahj.2020.09.006']
1746,32949954,A randomized control trial of meditation compared to music listening to improve cognitive function for breast cancer survivors: Feasibility and acceptability.,"BACKGROUND


and Purpose: Many breast cancer survivors (BCS) experience persistent cognitive and psychological changes associated with their cancer and/or treatment and that have limited treatment options. Therefore, the purpose of this study was to explore the feasibility and effects of a Kirtan Kriya meditation (KK) intervention on cognitive and psychological symptoms compared to an attention control condition, classical music listening (ML), in BCS.
MATERIALS AND METHODS


A randomized control trial design was used. Participants completed eight-week interventions. Cognitive function and psychological symptoms were measured at baseline and post-intervention. Mixed analysis of variance models were examined for all cognitive and psychological outcomes.
RESULTS


27 BCS completed the study. Intervention adherence was 88%. Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's < 0.01). There were no significant group by time effects for cognitive and psychological outcomes, except stress. The ML group reported lower stress at time 2 (p < 0.05).
CONCLUSION


KK and ML are feasible, acceptable, and cost-effective interventions that may be beneficial for survivors' cognition and psychological symptoms. Both interventions were easy to learn, low cost, and required just 12 min/day. Meditation or music listening could offer providers evidence-based suggestions to BCS experiencing cognitive symptoms.
CLINICAL TRIALS REGISTRATION NUMBER


NCT03696056.",2020,"Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's ",['breast cancer survivors'],"['Meditation or music listening', 'music listening', 'classical music listening (ML', 'Kirtan Kriya meditation (KK) intervention', 'meditation']","['cognitive and psychological symptoms', 'time effects for cognitive and psychological outcomes, except stress', ""perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's"", 'cognitive function', 'Cognitive function and psychological symptoms', 'Intervention adherence']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.062006,"Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's ","[{'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Henneghan', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA; The University of Texas at Austin, Department of Oncology, 1601 Trinity St, Austin, TX, 78712, USA. Electronic address: ahenneghan@utexas.edu.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Becker', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Harrison', 'Affiliation': 'The University of Texas at Austin, Kinesiology and Health Education, 2109 San Jacinto Blvd, Austin, TX, 78712, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Inselmann', 'Affiliation': 'Cancer Rehab and Integrative Medicine, 4130 Spicewood Springs Rd. Ste. 100, Austin, TX, 78759, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Fico', 'Affiliation': 'The University of Texas at Austin, Kinesiology and Health Education, 2109 San Jacinto Blvd, Austin, TX, 78712, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Schafer', 'Affiliation': 'The University of Texas at Austin, Dell Medical School, 1501 Red River Street St, Austin, TX, 78712, USA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'King', 'Affiliation': 'Division of Clinical Cancer Genomics City of Hope, 1500 E. Duarte Road, Duarte, CA, 91010, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Patt', 'Affiliation': 'Texas Oncology, The University of Texas at Austin, Department of Oncology, Dell Medical School, 1501 Red River Street St, Austin, TX, 78712, USA.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Kesler', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA; The University of Texas at Austin, Department of Diagnostic Medicine, 1601 Trinity St, Austin, TX, 78712, USA.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101228']
1747,32950737,"A pragmatic stepped-wedge cluster randomized trial to evaluate the effectiveness and cost-effectiveness of active case finding for household contacts within a routine tuberculosis program, San Juan de Lurigancho, Lima, Peru.","BACKGROUND


Active case finding (ACF) in household contacts of tuberculosis (TB) patients is now recommended for National TB Programs (NTP) in low- and middle-income countries. However, evidence supporting these recommendations remains limited. This study evaluates the effectiveness and cost-effectiveness of ACF for household contacts of TB cases in a large TB endemic district of Lima, Peru.
METHODS


A pragmatic stepped-wedge cluster randomized controlled trial was conducted in 34 health centers of San Juan de Lurigancho district. Centers were stratified by TB rate and randomly allocated to initiate ACF in groups of eight or nine centers at four-month intervals. In the intervention arm, NTP providers visited households of index patients to screen contacts for active TB. The control arm was routine passive case finding (PCF) of symptomatic TB cases. The primary outcomes were the crude and adjusted active TB case rates among household contacts. Program costs were directly measured, and the cost-effectiveness of the ACF intervention was determined.
FINDINGS


3222 index TB cases and 12,566 household contacts were included in the study. ACF identified more household contact TB cases than PCF, 199.29/10,000 contacts/year vs. 132.13 (incidence rate ratio of 1.51 (95% CI 1.21-1.88)). ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6360.
CONCLUSION


ACF of TB case household contacts detected significantly more secondary TB cases than PCF alone, but was not cost-effective in this setting. In threshold analyses, ACF becomes cost-effective if associated with case detection rates 2.5 times higher than existing PCF programs.",2020,"ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6,360.
","['household contacts of tuberculosis (TB) patients', '34 health centers of San Juan de Lurigancho district', 'household contacts of TB cases in a large TB endemic district of Lima, Peru', '3,222 index TB cases and 12,566 household contacts were included in the study']","['PCF', 'ACF']","['effectiveness and cost-effectiveness', 'crude and adjusted active TB case rates among household contacts', 'Program costs']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.240111,"ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6,360.
","[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Shah', 'Affiliation': 'Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Rojas Peña', 'Affiliation': 'Red de Salud de San Juan de Lurigancho, Dirección de Salud Lima IV Este, Ministerio de Salud, Lima, Peru.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Mori', 'Affiliation': 'Red de Salud de San Juan de Lurigancho, Dirección de Salud Lima IV Este, Ministerio de Salud, Lima, Peru.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zamudio', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Kaufman', 'Affiliation': 'Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Otero', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Gotuzzo', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Seas', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru; Departamento de Enfermedades Infecciosas, Tropicales y Dermatológicas, Hospital Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Brewer', 'Affiliation': 'Departments of Medicine and Epidemiology, David Geffen School of Medicine, Jonathan & Karin Fielding School of Public Health, University of California, Los Angeles, CA, United States. Electronic address: tbrewer@mednet.ucla.edu.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.09.034']
1748,32950763,Stress-induced modulation of multiple memory systems during retrieval requires noradrenergic arousal.,"Stress has been shown to favor dorsal striatum-dependent 'habit' memory over hippocampus-dependent 'cognitive' memory during learning. Here, we investigated whether stress may modulate the engagement of these 'cognitive' and 'habit' systems also during memory retrieval and if so, whether such a stress-induced shift in the control of memory retrieval depends on noradrenergic activation. To this end, participants acquired a probabilistic classification learning (PCL) task that can be solved by both the 'cognitive' and the 'habit' system, reflected in the distinct behavioral strategies. Twenty-four hours later, participants received either the beta-adrenergic receptor antagonist propranolol or a placebo before they underwent a psychosocial stressor or a non-stressful control manipulation, followed by a retrieval version of the PCL task. Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory. Stressed participants that had received a placebo fell back to a 'cognitive' strategy during retrieval, which was linked to an impairment in retrieval performance. Propranolol blocked this stress-induced shift towards the less efficient strategy. Moreover, our results showed that salivary cortisol was related to the retrieval strategy only when paralleled by increased autonomic arousal. Together, these results indicate that stress effects on the modulation of multiple memory system during retrieval necessitate noradrenergic arousal, with relevant implications for retrieval performance under stress.",2020,"Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory.",[],"['Propranolol', 'placebo', 'beta-adrenergic receptor antagonist propranolol or a placebo']","['autonomic arousal', 'salivary cortisol']",[],"[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}]","[{'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",,0.0560178,"Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory.","[{'ForeName': 'Gundula', 'Initials': 'G', 'LastName': 'Zerbes', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany.'}, {'ForeName': 'Franziska Magdalena', 'Initials': 'FM', 'LastName': 'Kausche', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany.'}, {'ForeName': 'Jana Christina', 'Initials': 'JC', 'LastName': 'Müller', 'Affiliation': 'Department of Psychiatry, University Clinic Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Wiedemann', 'Affiliation': 'Department of Psychiatry, University Clinic Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Schwabe', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany. Electronic address: lars.schwabe@uni-hamburg.de.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104867']
1749,32961617,"Irbesartan treatment does not influence plasma levels of the dicarbonyls methylglyoxal, glyoxal and 3-deoxyglucosone in participants with type 2 diabetes and microalbuminuria: An IRMA2 sub-study.","AIM


Angiotensin receptor blockers (ARBs) reduce vascular complications in diabetes independently of blood pressure. Experimental studies suggested that ARBs may restore the detoxifying enzyme glyoxalase 1, thereby lowering dicarbonyls such as methylglyoxal. Human data on the effects of ARBs on plasma dicarbonyl levels are lacking. We investigated, in individuals with type 2 diabetes, whether irbesartan lowered plasma levels of the dicarbonyls methylglyoxal, glyoxal, 3-deoxyglucosone and their derived advanced glycation end products (AGEs), and increased d-lactate, reflecting greater methylglyoxal flux.
METHODS


We analysed a subset of the Irbesartan in Patients with T2D and Microalbuminuria (IRMA2) study. We measured plasma dicarbonyls methylglyoxal, glyoxal and 3-deoxyglucosone, free AGEs and d-lactate using ultra-performance liquid chromatography tandem mass-spectrometry (UPLC-MS/MS) in the treatment arm receiving 300 mg irbesartan (n = 121) and a placebo group (n = 101) at baseline and after 1 and 2 years. Effect of treatment was analysed with repeated measurements ANOVA.
RESULTS


There was a slight, but significant difference in baseline median methylglyoxal levels [placebo 1119 (907-1509) nmol/l vs. irbesartan 300 mg 1053 (820-1427) nmol/l], but no significant changes were observed in any of the plasma dicarbonyls over time in either group and there was no effect of irbesartan treatment on plasma free AGEs or d-lactate levels at either 1 or 2 years.
CONCLUSION


Irbesartan treatment does not change plasma levels of the dicarbonyls methylglyoxal, glyoxal and 3-deoxyglucosone, free AGEs or d-lactate in type 2 diabetes. This indicates that increased dicarbonyls in type 2 diabetes are not targetable by ARBs, and other approaches to lower systemic dicarbonyls are needed in type 2 diabetes. (Clinical Trial Registry No: #NCT00317915).",2020,"CONCLUSION


Irbesartan treatment does not change plasma levels of the dicarbonyls methylglyoxal, glyoxal and 3-deoxyglucosone, free AGEs or d-lactate in type 2 diabetes.","['participants with type 2 diabetes and microalbuminuria', 'individuals with type 2 diabetes, whether irbesartan lowered plasma levels of the dicarbonyls methylglyoxal, glyoxal, 3-deoxyglucosone and their derived advanced glycation end products (AGEs), and increased d-lactate, reflecting greater methylglyoxal flux', 'Patients with T2D and Microalbuminuria (IRMA2) study']","['placebo', 'ARBs', 'Angiotensin receptor blockers (ARBs']","['baseline median methylglyoxal levels', 'plasma dicarbonyls', 'plasma dicarbonyl levels', 'plasma dicarbonyls methylglyoxal, glyoxal and 3-deoxyglucosone, free AGEs and d-lactate using ultra-performance liquid chromatography tandem mass-spectrometry (UPLC-MS/MS', 'plasma free AGEs or d-lactate levels']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0288171', 'cui_str': 'irbesartan'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034338', 'cui_str': 'Pyruvaldehyde'}, {'cui': 'C0017992', 'cui_str': 'Glyoxal'}, {'cui': 'C0047359', 'cui_str': '3-deoxyglucosone'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0522080', 'cui_str': 'D-lactate'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0034338', 'cui_str': 'Pyruvaldehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0017992', 'cui_str': 'Glyoxal'}, {'cui': 'C0047359', 'cui_str': '3-deoxyglucosone'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0522080', 'cui_str': 'D-lactate'}, {'cui': 'C0008565', 'cui_str': 'Liquid chromatography measurement'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}]",,0.0999158,"CONCLUSION


Irbesartan treatment does not change plasma levels of the dicarbonyls methylglyoxal, glyoxal and 3-deoxyglucosone, free AGEs or d-lactate in type 2 diabetes.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Piazza', 'Affiliation': 'Internal Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'N M J', 'Initials': 'NMJ', 'LastName': 'Hanssen', 'Affiliation': 'Internal Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Persson', 'Affiliation': 'Steno Diabetes Center Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Scheijen', 'Affiliation': 'Internal Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'M P H', 'Initials': 'MPH', 'LastName': 'van de Waarenburg', 'Affiliation': 'Internal Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'M M J', 'Initials': 'MMJ', 'LastName': 'van Greevenbroek', 'Affiliation': 'Internal Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hovind', 'Affiliation': 'Steno Diabetes Center Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'C D A', 'Initials': 'CDA', 'LastName': 'Stehouwer', 'Affiliation': 'Internal Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'H-H', 'Initials': 'HH', 'LastName': 'Parving', 'Affiliation': 'Medical Endocrinology, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'C G', 'Initials': 'CG', 'LastName': 'Schalkwijk', 'Affiliation': 'Internal Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14405']
1750,32948045,Comparison of the Effects of Visual and Auditory Distractions on Fistula Cannulation Pain among Older Patients Undergoing Hemodialysis: A Randomized Controlled Clinical Trial.,"Pain associated with fistula cannulation is a challenge for nurses who provide care to older patients undergoing hemodialysis. Several non-pharmacological methods have been suggested for relieving fistula cannulation pain, but the benefits of visual and auditory distraction methods among older patients undergoing hemodialysis have not been investigated yet. Therefore, this study aimed to compare the effects of visual and auditory distractions on fistula cannulation pain among older patients undergoing hemodialysis. This randomized controlled clinical trial was conducted on 120 older patients undergoing hemodialysis. They were randomly assigned to three groups of visual distraction, auditory distraction, and the control ( n  = 40 in each group) using a simple random assignment method. The distraction interventions continued for three consecutive sessions and the numeric rating scale of pain severity was used for data collection. Descriptive and inferential statistics were used for data analysis using SPSS. It was found that pain severity significantly reduced after the distraction interventions in either the auditory or visual distraction groups and also after all three distraction sessions ( p  = 0.001). However, visual distraction had a better effect on the reduction of pain severity. Therefore, while both visual and auditory distractions reduced pain severity in older patients undergoing hemodialysis, visual distraction was more effective. Nurses are encouraged to incorporate visual distraction as a safe and non-pharmacologic technique into routine nursing care for reducing older patients' suffering and improving their wellbeing when fistula cannulation is performed.",2020,It was found that pain severity significantly reduced after the distraction interventions in either the auditory or visual distraction groups and also after all three distraction sessions ( p  = 0.001).,"['Older Patients Undergoing Hemodialysis', 'older patients undergoing hemodialysis', 'older patients undergoing', '120 older patients undergoing hemodialysis']","['Visual and Auditory Distractions', 'hemodialysis, visual distraction', 'fistula cannulation', 'visual and auditory distractions', 'visual distraction, auditory distraction, and the control']","['fistula cannulation pain', 'Fistula Cannulation Pain', 'Pain', 'numeric rating scale of pain severity', 'pain severity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",120.0,0.0398348,It was found that pain severity significantly reduced after the distraction interventions in either the auditory or visual distraction groups and also after all three distraction sessions ( p  = 0.001).,"[{'ForeName': 'Mina Ghadimi', 'Initials': 'MG', 'LastName': 'Aghbolagh', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Bahrami', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Rejeh', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Majideh', 'Initials': 'M', 'LastName': 'Heravi-Karimooi', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Seyed Davood', 'Initials': 'SD', 'LastName': 'Tadrisi', 'Affiliation': 'Trauma Research Center, Faculty of Nursing, Baqiyatallah University of Medical Sciences, Tehran 1435916471, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Vaismoradi', 'Affiliation': 'Faculty of Nursing and Health Sciences, Nord University, 8049 Bodø, Norway.'}]","Geriatrics (Basel, Switzerland)",['10.3390/geriatrics5030053']
1751,32949918,A high-protein meal does not improve blood pressure or vasoactive biomarker responses to acute exercise in humans.,"Blood pressure (BP) responses to exercise yield prognostic information beyond resting BP. While habitual higher dietary protein intake is associated with reduced resting BP, few studies have assessed the impact of high-protein meals on acute BP and vasoactive biomarker responses to exercise. To test the hypothesis that consuming a higher-protein, lower fat meal (HP; 30 g protein, 17 g fat, 52 g carbohydrate) would attenuate the BP response to exercise and result in a more robust post-exercise hypotensive response compared to a lower-protein, higher-fat meal (LP; 13 g protein, 25 g fat, 54 g carbohydrate), we recruited 31 pre-hypertensive subjects to complete this randomized, double-blind, cross-over acute feeding study. One hundred sixty-five minutes after consuming the test HP or LP meal, subjects exercised on a cycle ergometer at 70% VO 2  max for 30 minutes. Blood pressure was measured prior to the meal and periodically before, during, and after exercise for a 315-minute period. Blood samples were periodically collected to quantify plasma arginine, arginine metabolites (asymmetric dimethylarginine, symmetric dimethylarginine; ADMA, SDMA), endothelin-1, nitrates, and nitrites in a subset of subjects (n = 15) as shown in Supplemental Table S1. Consuming the HP meal did not influence the BP responses to exercise, including the post-exercise return to baseline BP or systolic BP area under the curve. While the HP meal resulted in greater postprandial plasma arginine concentrations, ADMA, SDMA, endothelin-1, nitrates, and nitrites were unaltered. These results suggest that consuming a higher-protein, lower-fat meal does not influence BP or vasoactive biomarker responses to exercise compared to a lower-protein, higher-fat meal.",2020,"While the HP meal resulted in greater postprandial plasma arginine concentrations, ADMA, SDMA, endothelin-1, nitrates, and nitrites were unaltered.","['humans', '31 pre-hypertensive subjects']","['carbohydrate', 'HP meal']","['postprandial plasma arginine concentrations, ADMA, SDMA, endothelin-1, nitrates, and nitrites', 'plasma arginine, arginine metabolites (asymmetric dimethylarginine, symmetric dimethylarginine; ADMA, SDMA), endothelin-1, nitrates, and nitrites', 'BP responses', 'post-exercise return to baseline BP or systolic BP area under the curve', 'blood pressure or vasoactive biomarker responses', 'Blood pressure', 'BP response', 'Blood pressure (BP) responses']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0067305', 'cui_str': ""N,N'-dimethylarginine""}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.037945,"While the HP meal resulted in greater postprandial plasma arginine concentrations, ADMA, SDMA, endothelin-1, nitrates, and nitrites were unaltered.","[{'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Bergia', 'Affiliation': 'Department of Nutrition Science, Purdue University, 700 West State St, West Lafayette, IN 47907.'}, {'ForeName': 'Wayne W', 'Initials': 'WW', 'LastName': 'Campbell', 'Affiliation': 'Department of Nutrition Science, Purdue University, 700 West State St, West Lafayette, IN 47907. Electronic address: campbellw@purdue.edu.'}, {'ForeName': 'Bruno T', 'Initials': 'BT', 'LastName': 'Roseguini', 'Affiliation': 'Department of Health & Kinesiology, Purdue University, 800 W Stadium Ave, West Lafayette, IN 47907.'}, {'ForeName': 'Jung Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Food Science and Technology Programme, c/o Department of Chemistry, National University of Singapore, 3 Science Drive 3, Singapore 117543. Electronic address: chmkje@nus.edu.sg.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.08.001']
1752,32953086,Evaluation and pilot implementation of essential interventions for the management of hypertension and prevention of cardiovascular diseases in primary health care in the Republic of Tajikistan.,"Background:  Non-communicable diseases (NCDs) are the leading cause of death worldwide and are a major burden in Tajikistan. The health system of Tajikistan is still shaped by the country's Soviet legacy and the pace of reform has been slow, with high patient out-of-pocket expenditure. The aim of this study is to determine the feasibility of implementing and evaluating essential interventions for the management of hypertension and prevention of cardiovascular disease in primary health care in Tajikistan.  Methods and analysis:  A pragmatic, sequential mixed methods explanatory design, composed of quantitative and qualitative strands will be used with greater weighting of the quantitative strand. A single geographic district was nominated by the Ministry of Health and chosen for implementation. All primary health care centres in the district that meet inclusion criteria will be included; half will be randomly assigned to the intervention arm and half to the control arm. The overall process is organized into seven steps: (1) refresh clinical decision-making tools including open source WHO PEN and HEARTS resources; (2) update training package for primary health care workers; (3) collection of baseline data; (4) training staff in intervention clinics; (5) implementation of protocols and implementation coaching; (6) collection of follow-up data after 12 months; (7) evaluation of results and sharing experience.  Ethics and dissemination:  Ethical review and approval have been obtained. Findings will be disseminated at the participant level, national level through a national conference of key stakeholders, and internationally through publication in an open-access peer review journal.",2019,"The health system of Tajikistan is still shaped by the country's Soviet legacy and the pace of reform has been slow, with high patient out-of-pocket expenditure.","['All primary health care centres in the district that meet inclusion criteria will be included; half', 'primary health care in Tajikistan', 'primary health care in the Republic of Tajikistan']",['essential interventions'],[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039247', 'cui_str': 'Tajikistan'}]","[{'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0401091,"The health system of Tajikistan is still shaped by the country's Soviet legacy and the pace of reform has been slow, with high patient out-of-pocket expenditure.","[{'ForeName': 'Dylan R J', 'Initials': 'DRJ', 'LastName': 'Collins', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Laatikainen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Helsinki, Finland.'}, {'ForeName': 'Mekhri', 'Initials': 'M', 'LastName': 'Shoismatuloeva', 'Affiliation': 'World Health Organization Regional Office for Europe, Copenhagen, Denmark.'}, {'ForeName': 'Isfandiyor', 'Initials': 'I', 'LastName': 'Mahmudzoha', 'Affiliation': 'Ministry of Health and Social Protection, Dushanbe, Tajikistan.'}, {'ForeName': 'Zakriya', 'Initials': 'Z', 'LastName': 'Rahimov', 'Affiliation': 'Ministry of Health and Social Protection, Dushanbe, Tajikistan.'}, {'ForeName': 'Dilorom', 'Initials': 'D', 'LastName': 'Sultonova', 'Affiliation': 'Service of State Supervision for Medical Activities and Social Protection of the Population of the Republic of Tajikistan, Dushanbe, Tajikistan.'}, {'ForeName': 'Bunafsha', 'Initials': 'B', 'LastName': 'Jonova', 'Affiliation': 'Republican Clinical and Training Centre of Family Medicine, Dushanbe, Tajikistan.'}, {'ForeName': 'Jill L', 'Initials': 'JL', 'LastName': 'Farrington', 'Affiliation': 'World Health Organization Regional Office for Europe, Copenhagen, Denmark.'}]",F1000Research,['10.12688/f1000research.20234.1']
1753,32954487,Responder Profile to Pharmaceutical-Grade Chondroitin Sulfate: An Analysis of the CONCEPT Trial.,"INTRODUCTION


The recent CONCEPT study showed that 800 mg/day of pharmaceutical-grade chondroitin sulfate (CS) was superior to placebo and similar to celecoxib in reducing pain and improving function over 6 months in patients with symptomatic knee osteoarthritis (OA). We investigate, in the present study, whether a responder profile to CS could be defined (i.e., to determine a patient's profile with the best response to treatment).
METHODS


Subjects from the CS group of the CONCEPT study were included in the present analysis. Within the CS group, various subgroups were created on the basis of different categories of age, sex, body mass index, Kellgren and Lawrence grade, age since the beginning of OA, and baseline level of pain (i.e., VAS) or function (i.e., Lequesne index). The nonparametric Kruskal-Wallis (KW) test was applied to compare the VAS pain/Lequesne index evolutions between the subgroups, and the Dwass, Steel, Critchlow, Fligner (DSCF) procedure was used to compute multiple comparisons. The impact of various covariates on the VAS pain/Lequesne index evolution was assessed by means of multiple regression.
RESULTS


Across all analyses, the probability of response to CS treatment was significantly associated with the duration between the date of diagnosis and the initiation of treatment. In other words, the shorter the interval between the diagnosis and the beginning of the treatment, the higher the response for both pain and function, particularly for patients with a duration of less than 5 years compared to patients with a duration of 10 years or more. No other criteria were found to be consistently associated with the response to CS treatment.
CONCLUSION


The treatment of OA with CS has the highest chance of success if administered in the early stage of the disease. Further research with other clinical outcomes should be carried out prior to widespread application of these findings.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT03200288.",2020,"No other criteria were found to be consistently associated with the response to CS treatment.
","['Subjects from the CS group of the CONCEPT study were included in the present analysis', 'patients with symptomatic knee osteoarthritis (OA']","['OA with CS', 'pharmaceutical-grade chondroitin sulfate (CS', 'placebo', 'celecoxib']","['probability of response to CS treatment', 'Lequesne index evolution', 'pain and improving function', 'VAS pain']","[{'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0451257', 'cui_str': 'Lequesne index'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0274737,"No other criteria were found to be consistently associated with the response to CS treatment.
","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bruyère', 'Affiliation': 'Division of Public Health, Epidemiology and Health Economics, WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Ageing, University of Liège, Liège, Belgium. olivier.bruyere@uliege.be.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Dardenne', 'Affiliation': 'Department of Biostatistics, University of Liège, Liège, Belgium.'}, {'ForeName': 'Anne-Françoise', 'Initials': 'AF', 'LastName': 'Donneau', 'Affiliation': 'Department of Biostatistics, University of Liège, Liège, Belgium.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'Division of Public Health, Epidemiology and Health Economics, WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Ageing, University of Liège, Liège, Belgium.'}]",Advances in therapy,['10.1007/s12325-020-01484-x']
1754,32950477,Physical examination-indicated cerclage in twin pregnancy: a randomized controlled trial.,,2020,,['Twin pregnancy'],"['Physical Exam Indicated Cerclage', 'Letter to editor RE']",[],"[{'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1292825', 'cui_str': 'Cerclage'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]",[],,0.186319,,"[{'ForeName': 'Japleen', 'Initials': 'J', 'LastName': 'Kaur', 'Affiliation': 'Department of Obstetrics and Gynecology, Nehru Hospital, Postgraduate Institute of Medical Education and Research, 3rd floor, F block, Sector 12, Chandigarh, India 160012.'}, {'ForeName': 'Avir', 'Initials': 'A', 'LastName': 'Sarkar', 'Affiliation': 'Department of Obstetrics and Gynecology, Nehru Hospital, Postgraduate Institute of Medical Education and Research, 3rd floor, F block, Sector 12, Chandigarh, India 160012.'}, {'ForeName': 'Minakshi', 'Initials': 'M', 'LastName': 'Rohilla', 'Affiliation': 'Department of Obstetrics and Gynecology, Nehru Hospital, Postgraduate Institute of Medical Education and Research, 3rd floor, F block, Sector 12, Chandigarh, India 160012. Electronic address: minurohilla@yahoo.com.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.09.019']
1755,32950505,Social media use while listening to new material negatively affects short-term memory in college students.,"Increased access to electronic devices and the ubiquity of social media has resulted in a rapid rise in the prevalence of students ""multitasking"" while in a classroom setting. While some data indicate the use of electronic devices in class can improve the classroom environment, other studies demonstrate the opposite finding. Moreover, it remains unclear if using social networking sites such as Instagram impacts performance on cognitive tasks when students are presented new material and, if so, what features of Instagram modulate this response. Therefore, in the current study we examined if social media use during or after being presented new information affected short-term memory in college students. Additionally, we assessed if the type or quantity of topics displayed had a modulatory impact on memory. Forty-five college-aged (18-24 years of age) students completed the Logical Memory Immediate Recall (LM I) component of the Wechsler Memory Scale IV, a measure of auditory recognition memory. Subjects were randomly divided into a group that completed the LM I without distraction (controls), a group that completed the LM I while scrolling through their Instagram feed, or a group that completed the LM I after scrolling through their Instagram feed. Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01). Recall ability in the group that used Instagram after hearing the story was not statistically different from the controls. Differences were not observed in the number of topics appearing in subjects' Instagram feeds and no correlation was found between the number of topics on a subject's Instagram feed and memory recall ability. Collectively, these results suggest that individuals who use their phones to browse Instagram during class or in social settings might have a reduced ability to retain the information given to them when compared to those that are not using their phones scrolling on social media.",2020,Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01).,"['Forty-five college-aged (18-24 years of age', 'college students', 'College Students']","['LM I without distraction (controls), a group that completed the LM I while scrolling through their Instagram feed, or a group that completed the LM']","['Logical Memory Immediate Recall (LM I) component of the Wechsler Memory Scale IV, a measure of auditory recognition memory', 'Recall ability', 'short-term memory recall ability']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",,0.024727,Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01).,"[{'ForeName': 'Allyson', 'Initials': 'A', 'LastName': 'Spence', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Kierian', 'Initials': 'K', 'LastName': 'Beasley', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Gravenkemper', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hoefler', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ngo', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Ortiz', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Campisi', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA. Electronic address: jcampisi@regis.edu.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113172']
1756,32950853,Supporting coordination of children with ASD using neurological music therapy: A pilot randomized control trial comparing an elastic touch-display with tambourines.,"AIM


To evaluate the efficacy of Neurologic Music Therapy (NMT) using a traditional and a technological intervention (elastic touch-display) in improving the coordination of children with Autism Spectrum Disorder (ASD), as a primary outcome, and the timing and strength control of their movements as secondary outcomes.
METHODS


Twenty-two children with ASD completed 8 NMT sessions, as a part of a 2-month intervention. Participants were randomly assigned to either use an elastic touch-display (experimental group) or tambourines (control group). We conducted pre- and post- assessment evaluations, including the Developmental Coordination Disorder Questionnaire (DCDQ) and motor assessments related to the control of strength and timing of movements.
OUTCOMES AND RESULTS


All participants improved their coordination, according to the DCDQ scores, and exhibited better control of their movements according to the strength and timing assessments after the intervention. Participants who used the elastic touch-display scored higher on the DCDQ.
CONCLUSIONS AND IMPLICATIONS


NMT is an efficacious treatment to improve the coordination skills of children with ASD. Elastic touch-displays provide more benefits than the use of tambourines.",2020,"All participants improved their coordination, according to the DCDQ scores, and exhibited better control of their movements according to the strength and timing assessments after the intervention.","['children with Autism Spectrum Disorder (ASD', 'children with ASD', 'Twenty-two children with ASD completed 8 NMT sessions, as a part of a 2-month intervention', 'Participants who used the elastic touch-display scored higher on the DCDQ']","['Neurologic Music Therapy (NMT', 'elastic touch-display (experimental group) or tambourines (control group', 'technological intervention (elastic touch-display', 'neurological music therapy', 'elastic touch-display with tambourines']",['Developmental Coordination Disorder Questionnaire (DCDQ) and motor assessments related to the control of strength and timing of movements'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011757', 'cui_str': 'Developmental coordination disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",22.0,0.0293978,"All participants improved their coordination, according to the DCDQ scores, and exhibited better control of their movements according to the strength and timing assessments after the intervention.","[{'ForeName': 'Franceli L', 'Initials': 'FL', 'LastName': 'Cibrian', 'Affiliation': 'Fowler School of Engineering, Chapman University, Orange California, USA. Electronic address: cibrian@chapman.edu.'}, {'ForeName': 'Melisa', 'Initials': 'M', 'LastName': 'Madrigal', 'Affiliation': 'CETYS Universidad, Tijuana, Mexico. Electronic address: melisa.madrigal@cetys.edu.mx.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Avelais', 'Affiliation': 'CETYS Universidad, Tijuana, Mexico. Electronic address: marina.alvelais@cetys.mx.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Tentori', 'Affiliation': 'Computer Science Department, Center for Scientific Research and Higher Education of Ensenada (CICESE), Mexico. Electronic address: mtentori@cicese.mx.'}]",Research in developmental disabilities,['10.1016/j.ridd.2020.103741']
1757,32950885,First night effect on polysomnographic sleep bruxism diagnosis varies among young subjects with different degrees of rhythmic masticatory muscle activity.,"OBJECTIVE


This study investigated the first night effect on the polysomnographic diagnosis of sleep bruxism (SB).
METHODS


Polysomnographic recordings were performed for two consecutive nights in forty-three subjects (mean age 23.7 ± 0.32 years [range: 20.0-33.0]). Sleep variables and rhythmic masticatory muscle activity (RMMA) were scored for two nights. The diagnosis of SB was graded by the frequency of RMMA with cut-off values of two and four times per hour of sleep.
RESULTS


Participants were classified into control (n = 15), low (n = 13) and moderate-high (n = 15) groups. Among the three groups, the concordance of the SB diagnosis was compared between the two nights. Sleep variables showed a significant first-night effect with lower sleep efficiency, longer sleep latency and higher frequency of arousals. The frequency of RMMA significantly increased from the first to the second night in the moderate-high SB group only. The concordance rate of the severity between the two nights was 93.3% (14/15) in the control group, 76.9% (10/13) in the low SB group and 60% (9/15) in the moderate-high SB group. When the severity was determined on the first night, it remained the same on the second night in 77.8% (14/18) of the control group, 66.7% (10/15) of the low SB group and 90.0% (9/10) of the moderate-high SB group.
CONCLUSION


The results showed that the first night effect on the occurrence of RMMA differed among the different degrees of the RMMA frequency, and suggest that, due to the first night effect, single-night polysomnography may underestimate the moderate-high level of SB but differentiate the low level of SB from controls.",2020,"Sleep variables showed a significant first-night effect with lower sleep efficiency, longer sleep latency and higher frequency of arousals.","['Polysomnographic recordings were performed for two consecutive nights in forty-three subjects (mean age 23.7\xa0±\xa00.32 years [range: 20.0-33.0', 'young subjects with different degrees of rhythmic masticatory muscle activity', 'Participants were classified into control (n\xa0=\xa015), low (n\xa0=\xa013) and moderate-high (n\xa0=\xa015) groups']",[],"['concordance of the SB diagnosis', 'sleep efficiency, longer sleep latency and higher frequency of arousals', 'Sleep variables and rhythmic masticatory muscle activity (RMMA', 'occurrence of RMMA', 'frequency of RMMA', 'polysomnographic diagnosis of sleep bruxism (SB', 'concordance rate of the severity']","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517448', 'cui_str': '0.32'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024890', 'cui_str': 'Structure of muscle of mastication'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0751771', 'cui_str': 'Nocturnal Teeth Grinding Disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0024890', 'cui_str': 'Structure of muscle of mastication'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0114225,"Sleep variables showed a significant first-night effect with lower sleep efficiency, longer sleep latency and higher frequency of arousals.","[{'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Haraki', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Tsujisaka', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Toyota', 'Affiliation': 'Department of Prosthodontics, Gerodontology and Oral Rehabilitation, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan; Department of Oral Physiology, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Osaka University Graduate School of Dentistry, 1-8, Yamadaoka, Suita, Osaka, 565-0871, Japan; Department of Oral Physiology, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Adachi', 'Affiliation': 'Health and Counseling Center, Osaka University, 1-17 Machikaneyama-Cho, Toyonaka, Osaka, 560-0043, Japan; Osaka University Hospital, Sleep Medicine Center, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Ishigaki', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Yatani', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Taniike', 'Affiliation': 'Osaka University Hospital, Sleep Medicine Center, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan; Osaka University, United Graduate School of Child Development, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Osaka University Hospital, Sleep Medicine Center, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan; Osaka University, United Graduate School of Child Development, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan; Department of Oral Physiology, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan. Electronic address: takafumi@dent.osaka-u.ac.jp.'}]",Sleep medicine,['10.1016/j.sleep.2020.08.012']
1758,32950893,Smartphone based behavioral therapy for pain in multiple sclerosis (MS) patients: A feasibility acceptability randomized controlled study for the treatment of comorbid migraine and ms pain.,"BACKGROUND


Multiple Sclerosis (MS) and Migraine are comorbid neurologic conditions. Migraine prevalence is three times higher in the MS clinic population compared to the general population, and patients with MS and migraine are more symptomatic than patients with MS without migraine.
OBJECTIVE


We sought to conduct a pilot feasibility and acceptability study of the RELAXaHEAD app in MS-Migraine patients and to assess whether there was any change in migraine disability and MS pain-related disability.
METHODS


Randomized controlled study of patients with MS-migraine ages 18-80 years with 4+ headache days/ month who were willing to engage in smartphone based behavioral therapy. Half received the RELAXaHEAD app with progressive muscle relaxation (PMR) and the other half received the app without the PMR. Data was collected for 90 days on measures of recruitment, retention, engagement, and adherence to RELAXaHEAD. Preliminary data was also collected on migraine disability (MIDAS) and MS pain (PES).
RESULTS


Sixty-two subjects with MS-migraine were enrolled in the study (34 in PMR arm, 28 in monitored usual care arm). On average, during the 90 days, participants played the PMR on average 1.8 times per week, and for 12.9 min on days it was played. Forty-one percent (14/34) of the participants played the PMR two or more times weekly on average. Data was entered into the daily diaries, on average, 49% (44/90) of the days. There were major challenges in reaching subjects in follow-up for the efficacy data, and there was no significant change in migraine disability (MIDAS) scores or MS Pain (PES) scores from baseline to the endpoints. During the six-month follow-up, most patients felt either positively or neutral about the relaxation therapy.
CONCLUSION


There was interest in scalable accessible forms of behavioral therapy to treat migraine and MS-related pain in patients with MS and comorbid migraine. Similar to prior studies, a significant minority were willing to practice the PMR at least twice weekly. In the societal shift from telephone to more text and internet-based interactions, follow up was challenging, but those reached indicated that they appreciated the PMR and would recommend it to others. Future work should focus on engagement and efficacy.",2020,"Migraine prevalence is three times higher in the MS clinic population compared to the general population, and patients with MS and migraine are more symptomatic than patients with MS without migraine.
","['patients with MS-migraine ages 18-80 years with 4+ headache days/ month who were willing to engage in smartphone based behavioral therapy', 'Sixty-two subjects with MS-migraine were enrolled in the study (34 in PMR arm, 28 in monitored usual care arm', 'pain in multiple sclerosis (MS) patients']","['RELAXaHEAD app with progressive muscle relaxation (PMR', 'RELAXaHEAD', 'Smartphone based behavioral therapy']","['migraine disability and MS pain-related disability', 'recruitment, retention, engagement, and adherence to RELAXaHEAD', 'migraine disability (MIDAS) scores or MS Pain (PES) scores', 'migraine disability (MIDAS) and MS pain (PES', 'Migraine prevalence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",62.0,0.022569,"Migraine prevalence is three times higher in the MS clinic population compared to the general population, and patients with MS and migraine are more symptomatic than patients with MS without migraine.
","[{'ForeName': 'Mia T', 'Initials': 'MT', 'LastName': 'Minen', 'Affiliation': 'NYU Langone Health, Department of Neurology, 222 E 41st, Ninth floor, New York, NY, 10017. Electronic address: mia.minen@nyulangone.org.'}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Schaubhut', 'Affiliation': 'Columbia University, Post-baccalaureate Premed Program, 408 Lewisohn Hall, 2970 Broadway, New York, NY 10027.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Morio', 'Affiliation': 'Columbia University, Post-baccalaureate Premed Program, 408 Lewisohn Hall, 2970 Broadway, New York, NY 10027.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102489']
1759,32950920,The effect of marker size on three-dimensional motion analysis of the foot.,"BACKGROUND


In the field of three-dimensional motion analysis of the foot, there is little agreement on the preferred size of markers to record kinematic parameters. Although currently applied marker sizes show a considerable range, there has been no detailed investigation of the effect of marker size on the calculation of foot kinematics in the current literature.
RESEARCH QUESTION


The objective of this research was to determine whether marker size impacts essential parameters that describe foot biomechanics.
METHODS


Seventeen subjects participated in this randomized repeatability study. All participants had to walk on a treadmill twice to test two sets of markers (set A: small marker, 9.5 mm, 1 g; set B: large marker, 14 mm, 2 g). Three-dimensional motion capturing was used to record the trajectories of the markers. The spatial relation of the markers, as well as vertical motion of the navicular bone and the angle of the medial longitudinal arch were calculated based on the marker trajectories. In addition to motion capturing, skin rigidity was quantified by applying an oscillatory shear force to the skin. Analysis of variance, root-mean-square error calculations and linear fit methods were applied to evaluate effects of marker size on the calculation of foot kinematics and the impact of skin rigidity.
RESULTS


The estimated foot kinematics appeared to be unaffected by the size of the markers. Further, there was no evidence that skin rigidity influenced the error of the marker trajectories. Interestingly, the large markers fell off more frequently.
SIGNIFICANCE


The findings will be of interest to those who use marker-based three-dimensional motion capturing, especially to analyze foot biomechanics. Although the calculation of kinematic parameters appears to be unaffected by marker size, practical aspects, like accidental marker loss, favor the application of small markers.",2020,The estimated foot kinematics appeared to be unaffected by the size of the markers.,['Seventeen subjects participated'],[],"['estimated foot kinematics', 'skin rigidity']","[{'cui': 'C0450331', 'cui_str': '17'}]",[],"[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}]",17.0,0.0404244,The estimated foot kinematics appeared to be unaffected by the size of the markers.,"[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Ebrecht', 'Affiliation': 'Department of Human Locomotion, Chemnitz University of Technology, Straße der Nationen 62, 09111 Chemnitz, Germany. Electronic address: florian.ebrecht@hsw.tu-chemnitz.de.'}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Sichting', 'Affiliation': 'Department of Human Locomotion, Chemnitz University of Technology, Straße der Nationen 62, 09111 Chemnitz, Germany.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.007']
1760,32956008,Verbal Contingencies in the Lidcombe Program: A Noninferiority Trial.,"Purpose The Lidcombe Program is an efficacious and effective intervention for early stuttering. The treatment is based on parent verbal response contingent stimulation procedures, which are assumed to be responsible for treatment effect. The present trial tested this assumption. Method The design was a parallel, open plan, noninferiority randomized controlled trial. In the experimental arm, the five Lidcombe Program verbal contingencies were removed from parent instruction. The primary outcome was beyond-clinic percentage syllables stuttered at 18-month follow-up. Seventy-four children and their parents were randomized to one of the two treatment arms. Results Findings of noninferiority were inconclusive for the primary outcome of stuttering severity, based on a margin of 1.0 percentage syllables stuttered. Conclusions The inconclusive finding of noninferiority means it is possible that verbal contingencies make some contribution to the Lidcombe Program treatment effect. However, considering all primary and secondary outcomes, an overriding impression from the trial is a similarity of outcomes between the control and experimental arms. The clinical applications of the trial are discussed, along with further research that is needed.",2020,"Results Findings of noninferiority were inconclusive for the primary outcome of stuttering severity, based on a margin of 1.0 percentage syllables stuttered.","['Lidcombe Program', 'Seventy-four children and their parents']",['Lidcombe Program'],"['Verbal Contingencies', 'beyond-clinic percentage syllables stuttered']","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0038506', 'cui_str': 'Stuttering'}]",74.0,0.0786426,"Results Findings of noninferiority were inconclusive for the primary outcome of stuttering severity, based on a margin of 1.0 percentage syllables stuttered.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Donaghy', 'Affiliation': 'Australian Catholic University, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': ""O'Brian"", 'Affiliation': 'Australian Stuttering Research Centre, University of Technology Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Onslow', 'Affiliation': 'Australian Stuttering Research Centre, University of Technology Sydney, New South Wales, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Lowe', 'Affiliation': 'Australian Stuttering Research Centre, University of Technology Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'School of Public Health, The University of Queensland, Herston, Australia.'}, {'ForeName': 'Ross G', 'Initials': 'RG', 'LastName': 'Menzies', 'Affiliation': 'Australian Stuttering Research Centre, University of Technology Sydney, New South Wales, Australia.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-20-00155']
1761,32956506,Alkalinized lidocaine solution as a first-line local anesthesia protocol for intradetrusor injection of onabotulinum toxin A: Results from a double-blinded randomized controlled trial.,"AIMS


Local anesthesia protocols for intradetrusor onabotulinum toxin A (BoNTA) injection lack standardization. We aimed to determine if an alkalinized lidocaine solution is more effective than lidocaine only.
METHODS


Patients of both genders aged 18 or above enlisted for intradetrusor BoNTA injection (idiopathic, neurogenic, and bladder pain syndrome) were included in a double-blinded randomized controlled trial after obtaining their informed consent. All participants filled a bladder diary and a urine culture was performed. Subjects were randomized 1:1 to Protocol A (20 ml 2% lidocaine + 10 ml 8.4% sodium bicarbonate) or Protocol B (20 ml 2% lidocaine + 10 ml 0.9% saline solution). A Numeric Rating Scale (0-10) was used to assess the level of pain immediately after the procedure (primary endpoint). Secondary endpoints included pain after 1 h, urinary tract infection, acute urinary retention, and hematuria related to the procedure.
RESULTS


A total of 116 patients were randomized. Baseline characteristics (age, sex, indication, and bladder diary parameters) of patients in Group A and B were similar. Pain scores at the end of the procedure were significantly lower with the alkalinized solution (Protocol A and B, respectively, 2.37 ± 0.31 vs. 4.44 ± 0.36, p < .01). No differences were observed 1 h after treatment (Protocol A and B, respectively, 0.54 ± 0.17 vs. 0.69 ± 0.19, p = .487). The only adverse event reported was mild-to-moderate self-limited hematuria in 15.4% of patients.
CONCLUSIONS


The use of an alkalinized lidocaine solution has proven to be significantly superior to lidocaine only as local anesthesia before intradetrusor BoNTA injection, suggesting that this may be considered a first-line option.",2020,"Pain scores at the end of the procedure were significantly lower with the alkalinized solution (Protocol A and B, respectively, 2.37 ± 0.31 vs. 4.44 ± 0.36, p < .01).","['Patients of both genders aged 18 or above enlisted for intradetrusor BoNTA injection (idiopathic, neurogenic, and bladder pain syndrome', '116 patients were randomized']","['Alkalinized lidocaine solution', 'lidocaine\u2009+\u200910\u2009ml 8.4% sodium bicarbonate) or Protocol B (20\u2009ml 2% lidocaine\u2009', 'lidocaine', 'alkalinized lidocaine solution']","['level of pain', 'Pain scores', 'pain after 1\u2009h, urinary tract infection, acute urinary retention, and hematuria related to the procedure', 'Numeric Rating Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C1720830', 'cui_str': 'Bladder Pain Syndrome'}, {'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0341742', 'cui_str': 'Acute retention of urine'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",116.0,0.555031,"Pain scores at the end of the procedure were significantly lower with the alkalinized solution (Protocol A and B, respectively, 2.37 ± 0.31 vs. 4.44 ± 0.36, p < .01).","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Pereira E Silva', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário Lisboa Norte, Lisboa, Portugal.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Ponte', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário Lisboa Norte, Lisboa, Portugal.'}, {'ForeName': 'Filipe', 'Initials': 'F', 'LastName': 'Lopes', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário Lisboa Norte, Lisboa, Portugal.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Palma Dos Reis', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário Lisboa Norte, Lisboa, Portugal.'}]",Neurourology and urodynamics,['10.1002/nau.24519']
1762,32956682,"A feasibility study of application and potential effects of a single session transcranial direct current stimulation (tDCS) on competitive anxiety, mood state, salivary levels of cortisol and alpha amylase in elite athletes under a real-world competition.","OBJECTIVE


To examine feasibility and potential effects of a single session tDCS over the dorsolateral prefrontal cortex (DLPFC) on competitive anxiety, mood state, and autonomic and endocrine stress responses in elite archer athletes under a real world competition.
METHODS


Twelve male elite archers volunteered to participate in this pilot trial. Participants were randomized in order to take left anodal DLPFC, left cathodal DLPFC, or sham stimulation (the F3 or F4 areas according to the 10/20 EEG International System) in a within-subject study design. This study included three official competitions. About 45 min before the competition, the tDCS stimulation process was started and the participants were stimulated for 20 min with 2 mA current. Psychophysiological responses, including Brunel Mood Scale and Competitive state anxiety inventory-2-revied, were collected 15 min before each competition. Additionally, salivary cortisol (sCort) and salivary alpha-amylase (sAA) were collected 1 hour and 10 min before competition as well as 10 min and 1 hour after competition.
RESULTS


Findings demonstrated that anodal tDCS was feasible and could lead to enhance mood state (vigor, tension and fatigue) and a decrease in competitive anxiety, as compared to cathodal and sham stimulation (all p < 0.05). However, self-confidence remained unaffected by the tDCS (p > 0.05). Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05). Correlations between competitive anxiety and mood states with physiological stress markers (sCort and sAA) were not significant (all p > 0.05).
CONCLUSIONS


The present study provides the first preliminary evidence that anodal tDCS over the DLPFC is feasible and could modulate competitive anxiety and physiological stress responses to the acute stress of competition (potentially by a top-down regulation of HPA and SAM systems as well as the vagal system). Findings support the notion that non-invasive brain stimulation might be advantageous to enhance sport performance under competitive situations. However, additional studies in a larger sample size and different sport activities are encouraged to substantiate the findings.",2020,Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05).,"['elite athletes under a real-world competition', 'elite archer athletes under a real world competition', 'Twelve male elite archers volunteered to participate in this pilot trial']","['anodal tDCS', 'single session transcranial Direct Current Stimulation (tDCS', 'left anodal DLPFC, left cathodal DLPFC, or sham stimulation (the F3 or F4 areas according to the 10/20 EEG International System', 'single session tDCS']","['lower salivary cortisol and alpha-amylase response', 'competitive anxiety and mood states with physiological stress markers (sCort and sAA', 'competitive anxiety, mood state, salivary levels of cortisol and alpha amylase', 'competitive anxiety', 'competitive anxiety, mood state, and autonomic and endocrine stress responses', 'Psychophysiological responses, including Brunel Mood Scale and Competitive State Anxiety inventory-2-Revied', 'salivary cortisol (sCort) and salivary alpha-amylase (sAA', 'enhance mood state (vigor, tension and fatigue']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449430', 'cui_str': 'Physiological stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",12.0,0.0310646,Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05).,"[{'ForeName': 'Amir Hossien', 'Initials': 'AH', 'LastName': 'Mehrsafar', 'Affiliation': 'Department of Sport Psychology, Faculty of Sport Sciences, University of Tehran, Tehran, Iran. Electronic address: a.mehrsafar@ut.ac.ir.'}, {'ForeName': 'Miguel Angel Serrano', 'Initials': 'MAS', 'LastName': 'Rosa', 'Affiliation': 'Department of Psychobiology, Faculty of Psychology, University of Valencia, Valencia, Spain; Laboratory of Cognitive and Affective Neuroscience, Faculty of psychology, University of Valencia, Valencia, Spain. Electronic address: m.angel.serrano@uv.es.'}, {'ForeName': 'Ali Moghadam', 'Initials': 'AM', 'LastName': 'Zadeh', 'Affiliation': 'Department of Psychology, Faculty of Psychology and Education, University of Tehran, Tehran, Iran. Electronic address: amoghadamzadeh@ut.ac.ir.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Gazerani', 'Affiliation': 'Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg E, Denmark. Electronic address: gazerani@hst.aau.dk.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113173']
1763,32965047,Follow-up of offspring and mothers with gestational diabetes treated with metformin or glibenclamide: A randomized controlled trial.,,2020,"The present study followed up 78 (49%) of 159 women that were randomized, along with their offspring, to compare adiposity, anthropometric measurements, and prevalence of diabetes between the two treatment groups.","['up 78 (49%) of 159 women', 'moderate gestational diabetes mellitus']","['glibenclamide', 'metformin and glibenclamide', 'metformin', 'metformin or glibenclamide']",['neonatal outcomes'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",159.0,0.108702,"The present study followed up 78 (49%) of 159 women that were randomized, along with their offspring, to compare adiposity, anthropometric measurements, and prevalence of diabetes between the two treatment groups.","[{'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Paul', 'Affiliation': 'Department of Pediatrics, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Priyambada', 'Affiliation': 'Department of Pediatrics, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Abraham', 'Affiliation': 'Department of Obstetrics and Gynecology, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Babuji', 'Initials': 'B', 'LastName': 'Manimegalai', 'Affiliation': 'Department of Dietetics, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Thomas V', 'Initials': 'TV', 'LastName': 'Paul', 'Affiliation': 'Department of Endocrinology Diabetes and Metabolism, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Sneha', 'Initials': 'S', 'LastName': 'Princy', 'Affiliation': 'Department of Bio-Statistics, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Balevendra', 'Initials': 'B', 'LastName': 'Antonisamy', 'Affiliation': 'Department of Bio-Statistics, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Thomas', 'Affiliation': 'Department of Endocrinology Diabetes and Metabolism, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Hilda', 'Initials': 'H', 'LastName': 'Yenuberi', 'Affiliation': 'Department of Obstetrics and Gynecology, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Jiji E', 'Initials': 'JE', 'LastName': 'Mathews', 'Affiliation': 'Department of Obstetrics and Gynecology, Christian Medical College, Vellore, Tamil Nadu, India.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13380']
1764,32965602,Correction to: Efficacy and safety results from a randomized double-blind study comparing proposed biosimilar ABP 798 with rituximab reference product in subjects with moderate-to-severe rheumatoid arthritis.,This article originally published with the family name and given names of all authors transposed.,2020,This article originally published with the family name and given names of all authors transposed.,['subjects with moderate-to-severe rheumatoid arthritis'],['biosimilar ABP 798 with rituximab reference product'],[],"[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0001239', 'cui_str': 'Actin-binding protein'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]",[],,0.233974,This article originally published with the family name and given names of all authors transposed.,"[{'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Burmester', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Free University and Humboldt University Berlin, Charité University Medicine Berlin, Charitéplatz 1, 10117, Berlin, Germany. gerd.burmester@charite.de.'}, {'ForeName': 'Edit', 'Initials': 'E', 'LastName': 'Drescher', 'Affiliation': 'Veszprém Csolnoky Ferenc County Hospital, Veszprém, Hungary.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Hrycaj', 'Affiliation': 'Rheumatology, Koscian Municipal Hospital, Koscian, Poland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chien', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Metroplex Clinical Research Center, Dallas, TX, USA.'}]",Clinical rheumatology,['10.1007/s10067-020-05410-y']
1765,32965617,Efficacy and Safety of CT-P13 in Inflammatory Bowel Disease after Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trials.,"BACKGROUND


The NOR-SWITCH main and extension trials demonstrated that switching from originator to biosimilar infliximab (CT-P13) is efficacious and safe across six diseases. However, a subgroup analysis of Crohn's disease (CD) in the main trial displayed a close to significant difference favouring originator infliximab, and more scientific data have therefore been requested.
OBJECTIVE


The aim was to assess treatment efficacy, safety, and immunogenicity in an explorative subgroup analysis in CD and ulcerative colitis (UC) in the NOR-SWITCH trials.
PATIENTS AND METHODS


The 52-week, randomised, non-inferiority, double-blind, multicentre, phase 4 NOR-SWITCH study was followed by a 26-week open extension trial where all patients received treatment with CT-P13. Treatment efficacy, safety, and immunogenicity in CD and UC were assessed throughout the 78-week study period.
RESULTS


The main and extension trials included 155 and 93 patients with CD and 93 and 80 patients with UC, respectively. Demographic and baseline characteristics were comparable in both treatment arms within patient groups. There were no differences in the main and extension trials regarding changes in activity indices, C-reactive protein, faecal calprotectin, patient's and physician's global assessment of disease activity and patient-reported outcome measures in CD and UC. Moreover, comparable results were also demonstrated for trough serum levels, presence of anti-drug antibodies, and reported adverse events.
CONCLUSION


Efficacy, safety, and immunogenicity of both the originator and biosimilar infliximab were comparable in CD and UC in the NOR-SWITCH main and extension trials. These explorative subgroup analyses confirm that there are no significant concerns related to switching from originator infliximab to CT-P13 in CD and UC.
TRIAL REGISTRATION


ClinicalTrials.gov, number NCT02148640.",2020,"There were no differences in the main and extension trials regarding changes in activity indices, C-reactive protein, faecal calprotectin, patient's and physician's global assessment of disease activity and patient-reported outcome measures in CD and UC.","['155 and 93 patients with CD and 93 and 80 patients with UC, respectively']","['originator and biosimilar infliximab', 'CT-P13']","['treatment efficacy, safety, and immunogenicity', 'Efficacy, safety, and immunogenicity', ""activity indices, C-reactive protein, faecal calprotectin, patient's and physician's global assessment of disease activity and patient-reported outcome measures in CD and UC"", 'Treatment efficacy, safety, and immunogenicity in CD and UC', 'trough serum levels, presence of anti-drug antibodies, and reported adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}]","[{'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C3884615', 'cui_str': 'CT-P13'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.241068,"There were no differences in the main and extension trials regarding changes in activity indices, C-reactive protein, faecal calprotectin, patient's and physician's global assessment of disease activity and patient-reported outcome measures in CD and UC.","[{'ForeName': 'Kristin K', 'Initials': 'KK', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Gastroenterology, Akershus University Hospital, Sykehusveien 75, 1478, Lørenskog, Norway. kristin.kaasen.jorgensen@ahus.no.'}, {'ForeName': 'Guro L', 'Initials': 'GL', 'LastName': 'Goll', 'Affiliation': 'Division of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Sexton', 'Affiliation': 'Division of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Bolstad', 'Affiliation': 'Department of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Oslo, Norway.'}, {'ForeName': 'Inge C', 'Initials': 'IC', 'LastName': 'Olsen', 'Affiliation': 'Research Support Services CTU, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Asak', 'Affiliation': 'Department of Gastroenterology, Gjøvik Hospital, Gjøvik, Norway.'}, {'ForeName': 'Ingrid P', 'Initials': 'IP', 'LastName': 'Berset', 'Affiliation': 'Department of Gastroenterology, Ålesund Hospital, Ålesund, Norway.'}, {'ForeName': 'Ingrid M', 'Initials': 'IM', 'LastName': 'Blomgren', 'Affiliation': 'Department of Gastroenterology, Haugesund Hospital, Haugesund, Norway.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Dvergsnes', 'Affiliation': 'Department of Gastroenterology, Sørlandet Hospital, Kristiansand, Norway.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Florholmen', 'Affiliation': 'Department of Gastroenterology, University Hospital North Norway, Tromsø, Norway.'}, {'ForeName': 'Svein O', 'Initials': 'SO', 'LastName': 'Frigstad', 'Affiliation': 'Department of Medicine, Vestre Viken Bærum Hospital, Gjettum, Norway.'}, {'ForeName': 'Magne', 'Initials': 'M', 'LastName': 'Henriksen', 'Affiliation': 'Department of Gastroenterology, Østfold Hospital, Fredrikstad, Norway.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Hagfors', 'Affiliation': 'Patient Representative, Landsforeningen for Fordøyelsessykdommer, Oslo, Norway.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Huppertz-Hauss', 'Affiliation': 'Department of Gastroenterology, Telemark Hospital, Skien, Norway.'}, {'ForeName': 'Espen A', 'Initials': 'EA', 'LastName': 'Haavardsholm', 'Affiliation': 'Division of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Rolf A', 'Initials': 'RA', 'LastName': 'Klaasen', 'Affiliation': 'Department of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Oslo, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Moum', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Geir', 'Initials': 'G', 'LastName': 'Noraberg', 'Affiliation': 'Department of Gastroenterology, Sørlandet Hospital, Arendal, Norway.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Prestegård', 'Affiliation': 'Department of Gastroenterology, Lillehammer Hospital, Lillehammer, Norway.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Rydning', 'Affiliation': 'Department of Gastroenterology, Akershus University Hospital, Sykehusveien 75, 1478, Lørenskog, Norway.'}, {'ForeName': 'Liv', 'Initials': 'L', 'LastName': 'Sagatun', 'Affiliation': ""Department of Gastroenterology, Sankt Olav's Hospital, Trondheim, Norway.""}, {'ForeName': 'Kathrine A', 'Initials': 'KA', 'LastName': 'Seeberg', 'Affiliation': 'Department of Gastroenterology, Vestfold Hospital, Tønsberg, Norway.'}, {'ForeName': 'Roald', 'Initials': 'R', 'LastName': 'Torp', 'Affiliation': 'Department of Gastroenterology, Hamar Hospital, Hamar, Norway.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Vold', 'Affiliation': 'Department of Gastroenterology, Bodø Hospital, Bodø, Norway.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Warren', 'Affiliation': 'Department of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Oslo, Norway.'}, {'ForeName': 'Carl M', 'Initials': 'CM', 'LastName': 'Ystrøm', 'Affiliation': 'Department of Gastroenterology, Elverum Hospital, Elverum, Norway.'}, {'ForeName': 'Knut E A', 'Initials': 'KEA', 'LastName': 'Lundin', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Kvien', 'Affiliation': 'Division of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Jahnsen', 'Affiliation': 'Department of Gastroenterology, Akershus University Hospital, Sykehusveien 75, 1478, Lørenskog, Norway.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-020-00438-7']
1766,32960998,"Performance, acceptability, and validation of a phone application bowel diary.","AIMS


To assess performance, acceptability, external validity, and reliability of a phone application electronic bowel diary (PFDN Bowel eDiary).
METHODS


Women reporting refractory accidental bowel leakage (ABL) were enrolled in a randomized, crossover trial evaluating paper versus eDiary documentation of bowel movements (BM) and fecal incontinence episodes (FIE). Events were characterized by the presence or absence of urgency and Bristol stool scale consistency. The eDiary entries were date/time stamped and prompted by twice-daily phone notifications. Women were randomized to complete up to three consecutive 14-day diaries in two sequences. Diary events were compared between formats using the Pearson correlation. System usability scale (SUS) assessed eDiary usability. The eDiary test-retest reliability was assessed with intraclass correlations (ICCs).
RESULTS


Paired diary data were available from 60/69 (87%) women 63.8 ± 9.8 years old with mean 13.2 BM per week and 6.5 FIE per week (nearly half with urgency). Among those providing diaries, adherence did not differ by paper or eDiary (93.3% vs. 95.0%). Notifications prompted 29.6% of eDiary entries, improving adherence from 70% to 95%. Paper and eDiaries were moderate to-strongly correlated for BMs per week (r = .61), urgency BMs per week (r = .76), FIE per week (r = .66), urgency FIE per week (r = .72). Test-retest reliability was good (ICC = .81 BMs per week, .79 urgency BMs per week, .74 FIE per week, and .62 urgency FIE per week). The mean SUS score was high, 82.3 ± 17.5 (range, 0-100) with 91.4% rating it easy to use, and 75.9% preferring the eDiary over paper.
CONCLUSION


The PFDN Bowel eDiary correlated well with paper diary was considered easy to use, preferred to paper diaries, had high rates of confirmed real-time diary completion that obviated staff data entry.",2020,Test-retest reliability was good,['Women reporting refractory accidental bowel leakage (ABL'],['phone application electronic bowel diary (PFDN Bowel eDiary'],"['Diary events', 'System usability scale (SUS) assessed eDiary usability', 'Performance, acceptability, and validation of a phone application bowel diary', 'urgency BMs per week ', 'performance, acceptability, external validity, and reliability', 'presence or absence of urgency and Bristol stool scale consistency', 'bowel movements (BM) and fecal incontinence episodes (FIE', 'mean SUS score', 'urgency FIE']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0000924', 'cui_str': 'Accident'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]","[{'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.0331857,Test-retest reliability was good,"[{'ForeName': 'Halina M', 'Initials': 'HM', 'LastName': 'Zyczynski', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh/Magee-Womens Research Institute, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': ""Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women's and Infants Hospital, Providence, Rhode Island, USA.""}, {'ForeName': 'Lily A', 'Initials': 'LA', 'LastName': 'Arya', 'Affiliation': 'Department of Obstetrics and Gynecology, Hospital of University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Lukacz', 'Affiliation': 'Department of Reproductive Medicine, UC San Diego Health Care System, San Diego, California, USA.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Visco', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Rahn', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern, Dallas, Texas, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Carper', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, Durham, NC, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurourology and urodynamics,['10.1002/nau.24520']
1767,32960999,"Which combination is most effective in women with idiopathic overactive bladder, including bladder training, biofeedback, and electrical stimulation? A prospective randomized controlled trial.","OBJECTIVE


To evaluate the efficacy of single and combined use of biofeedback (BF) and electrical stimulation (ES) added to bladder training (BT) on incontinence-related quality of life (QoL) and clinical parameters in women with idiopathic overactive bladder (OAB).
MATERIAL AND METHODS


Seventy women were randomized into four groups as follows: Group 1 received BT alone (n = 18), Group 2 received BT + BF (n = 17), Group 3 received BT + ES (n = 18), and Group 4 received BT + BF + ES (n = 17). BF and ES were performed 3 days a week, 20 min a day, a total of 24 sessions for 8 weeks. All women were evaluated in terms of incontinence severity (pad test), pelvic floor muscles strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes, and number of pads), QoL (incontinence impact questionnaire), treatment success (positive response rate), cure/improvement rate, treatment satisfaction (Likert scale), and discomfort level (visual analog scale).
RESULTS


At the end of the treatment, severity of incontinence, frequency of voiding, incontinence episodes, and treatment satisfaction significantly improved in Group 3 and Group 4 compared with the other two groups. In Group 3 and Group 4, high statistically significant values were found in cure/improvement and positive response rates as opposed to Group 1 and Group 2. In Group 2 and Group 3, statistically significant improvements were seen in nocturia and QoL compared with Group 1. Moreover, statistically significant improvements in nocturia and QoL were found in Group 4 compared with the other three groups. There was no difference in the discomfort level of application between the groups.
CONCLUSION


We conclude that in the first-line conservative treatment of women with idiopathic OAB: (i) adding BF and/or ES to BT increases treatment effectiveness, (ii) clinical efficiency is greater when the combination includes ES, (iii) BT + BF + ES (triple combination) is the most effective treatment option in reducing nocturia and improving QoL.",2020,"In Group 3 and Group 4, high statistically significant values were found in cure/improvement and positive response rates as opposed to Group 1 and Group 2.","['women with idiopathic overactive bladder', 'women with idiopathic overactive bladder (OAB', 'women with idiopathic OAB', 'Seventy women were randomized into four groups as follows']","['biofeedback (BF) and electrical stimulation (ES) added to bladder training (BT', 'BT\xa0+\xa0BF', 'BT + BF + ES', 'BT alone', 'BT\xa0+\xa0ES']","['nocturia and QoL', 'severity of incontinence, frequency of voiding, incontinence episodes, and treatment satisfaction', 'nocturia and improving QoL', 'incontinence severity (pad test), pelvic floor muscles strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes, and number of pads), QoL (incontinence impact questionnaire), treatment success (positive response rate), cure/improvement rate, treatment satisfaction (Likert scale), and discomfort level (visual analog scale', 'discomfort level of application', 'incontinence-related quality of life (QoL', 'cure/improvement and positive response rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0150474', 'cui_str': 'Urinary bladder training'}]","[{'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",70.0,0.0805382,"In Group 3 and Group 4, high statistically significant values were found in cure/improvement and positive response rates as opposed to Group 1 and Group 2.","[{'ForeName': 'Sule', 'Initials': 'S', 'LastName': 'Firinci', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Necmettin', 'Initials': 'N', 'LastName': 'Yildiz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Alkan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Zafer', 'Initials': 'Z', 'LastName': 'Aybek', 'Affiliation': 'Department of Urology, Faculty of Medicine, Pamukkale University, Denizli, Turkey.'}]",Neurourology and urodynamics,['10.1002/nau.24522']
1768,32974974,The impact of occlusive vs non-occlusive application of 5-aminolevulinic acid (BF-200 ALA) on the efficacy and tolerability of photodynamic therapy for actinic keratosis on the scalp and face: A prospective within-patient comparison trial.,"BACKGROUND


Photodynamic therapy (PDT) is an effective treatment for actinic keratoses (AK). PDT is usually performed with occlusion of the photosensitizer prior to subsequent illumination.
OBJECTIVES


This study aimed to compare the efficacy and tolerability of occlusive versus non-occlusive application of a 5-aminolevulinic gel (BT-200 ALA) for PDT of multiple AK on the scalp or face.
METHODS


Prospective, investigator-blinded, within-patient comparison study on 45 patients. PDT with occlusion of ALA was performed in a target area on one randomized side of the scalp or face. One week later a contralateral target area received the same treatment except that no occlusion of the ALA gel was performed. 3 and 6 months after PDT, the clearance rate of a predetermined target lesion and the total clearance rate of all AK within the treated areas were determined. PDT-induced pain and skin phototoxicity and cosmetic outcome were also recorded.
RESULTS


Clearance rate of the target AK and total AK clearance rate at 3 months after PDT was 88.4% and 90.6% for occlusive PDT and 58.1% (P = .001) and 70.4% (P = .04) for non-occlusive PDT. The corresponding values at 6 months after PDT were 69.7% and 72.1% for occlusive PDT and 30.2% (P < .001) and 35.6% (P = .001) for non-occlusive PDT. Pain score and skin phototoxicity were significantly higher after occlusive ALA application. No difference was observed with respect to cosmetic outcome.
CONCLUSIONS


Occlusive application of ALA significantly improves the efficacy of PDT but is associated with more pain and increased phototoxicity.",2020,"No difference was observed with respect to cosmetic outcome.
","['actinic keratoses (AK', 'actinic keratosis on the scalp and face', '45 patients']","['PDT with occlusion of ALA', 'Photodynamic therapy (PDT', '5-aminolaevulinic gel (BT-200 ALA', 'photodynamic therapy', '5-aminolaevulinic acid (BF-200 ALA']","['pain and increased phototoxicity', 'clearance rate of a predetermined target lesion and the total clearance rate', 'Pain score and skin phototoxicity', 'PDT-induced pain and skin phototoxicity and cosmetic outcome', 'efficacy and tolerability', 'cosmetic outcome', 'Clearance rate of the target AK and total AK clearance rate']","[{'cui': 'C0439681', 'cui_str': 'Actinic'}, {'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C3490787', 'cui_str': 'BF-200 ALA'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0162830', 'cui_str': 'Phototoxic dermatitis'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439681', 'cui_str': 'Actinic'}]",45.0,0.0397044,"No difference was observed with respect to cosmetic outcome.
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Meierhofer', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Silic', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Urban', 'Affiliation': 'Trauma Hospital Klagenfurt, Klagenfurt am Wörthersee, Austria.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Tanew', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Radakovic', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}]","Photodermatology, photoimmunology & photomedicine",['10.1111/phpp.12613']
1769,32975061,"A New Thermo-Responsive Hyaluronic Acid Sol-Gel to Prevent Intrauterine Adhesions after Hysteroscopic Surgery: A Randomized, Non-Inferiority Trial.","PURPOSE


To investigate the efficacy and safety of a newly developed thermo-responsive sol-gel, ABT13107, for reducing the formation of intrauterine adhesions (IUAs) after hysteroscopic surgery.
MATERIALS AND METHODS


In this multicenter, prospective, randomized trial (Canadian Task Force classification I), 192 women scheduled to undergo a hysteroscopic surgery at one of the eight university hospitals in South Korea were randomized into the ABT13107 group or the comparator (Hyalobarrier®) group in a 1:1 ratio. During hysteroscopic surgery, ABT13107 or Hyalobarrier® was injected to sufficiently cover the entire intrauterine cavity.
RESULTS


The patients returned to their respective sites for safety assessments at postoperative weeks 1 and 4 and for efficacy assessments at postoperative week 4. The post-surgery incidence of IUAs was 23.4% in the ABT13107 group and 25.8% in the comparator group; this difference met the criteria for ABT13107 to be considered as not inferior to the comparator. No differences were found in the extent of adhesions, types of adhesions, or the cumulative American Fertility Society score between the two treatment groups. Most adverse events were mild in severity, and no serious adverse events occurred.
CONCLUSION


ABT13107, a new anti-adhesive barrier containing hyaluronic acid, was not inferior to the highly viscous hyaluronic acid anti-adhesive barrier, Hyalurobarrier® in IUA formation after hysteroscopic surgery (Clinical trial registration No. NCT04007211).",2020,"No differences were found in the extent of adhesions, types of adhesions, or the cumulative American Fertility Society score between the two treatment groups.","['192 women scheduled to undergo a hysteroscopic surgery at one of the eight university hospitals in South Korea', 'Intrauterine Adhesions after Hysteroscopic Surgery']","['Hyaluronic Acid Sol-Gel', 'ABT13107 group or the comparator (Hyalobarrier®']","['efficacy and safety', 'extent of adhesions, types of adhesions, or the cumulative American Fertility Society score', 'post-surgery incidence of IUAs']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0751614', 'cui_str': 'Surgical Procedures, Hysteroscopic'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0241593', 'cui_str': 'Adhesions of uterus'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0241593', 'cui_str': 'Adhesions of uterus'}]",192.0,0.121343,"No differences were found in the extent of adhesions, types of adhesions, or the cumulative American Fertility Society score between the two treatment groups.","[{'ForeName': 'Dong Yun', 'Initials': 'DY', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics & Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Sa Ra', 'Initials': 'SR', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics & Gynecology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seul Ki', 'Initials': 'SK', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics & Gynecology, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Jong Kil', 'Initials': 'JK', 'LastName': 'Joo', 'Affiliation': 'Department of Obstetrics & Gynecology, Pusan National University School of Medicine, Busan, Korea.'}, {'ForeName': 'Woo Shun', 'Initials': 'WS', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Medytox Inc., Seoul, Korea.'}, {'ForeName': 'Jung Ho', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Department of Obstetrics & Gynecology, Guro Hospital, College of Medicine, Korea University, Seoul, Korea.'}, {'ForeName': 'SiHyun', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Department of Obstetrics & Gynecology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Joon Cheol', 'Initials': 'JC', 'LastName': 'Park', 'Affiliation': 'Department of Obstetrics & Gynecology, Keimyung University School of Medicine, Daegu, Korea. jcpark@dsmc.or.kr.'}, {'ForeName': 'Sung Hoon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics & Gynecology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. kimsung@amc.seoul.kr.'}]",Yonsei medical journal,['10.3349/ymj.2020.61.10.868']
1770,32950613,A 4-week exercise and protein program improves muscle mass and physical functioning in older adults - A pilot study.,"BACKGROUND


Prehabilitation might attenuate common surgery-induced losses in muscle mass and physical performance. Beneficial effects of physical exercise with protein supplementation have been reported in older adults, but typically after an intervention of at least 12 weeks. The time-window for pre-surgery training is often limited to around 30 days, and it is not known if it is possible to achieve comparable results in such a short time window.
OBJECTIVES


The aim of this study was to pilot-test the effectiveness of a controlled four-week combined exercise and protein supplementation program on skeletal muscle-related outcomes in a Dutch older adult population.
DESIGN


This study was a one-armed pilot trial.
PARTICIPANTS


Seventeen older men and women, aged 55-75y, not scheduled for surgery.
INTERVENTION


A 4-week intervention program consisting of a twice-weekly supervised resistance and high-intensity aerobic exercise training of 75 min, combined with daily protein supplementation (2 doses of 15.5 g/day at breakfast and lunch).
MEASUREMENT


After two and four weeks, isometric quadriceps maximal voluntary contraction (MVC) was assessed via Biodex and quadriceps cross-sectional area (CSA) via magnetic resonance imaging. Other outcome measures were handgrip strength, chair rise time and maximal aerobic capacity (VO 2 -max), as assessed from a submaximal exercise test.
RESULTS


Compliance to the supervised training sessions (99.3%) and the protein supplementation (97%) was very high. The 4-week exercise and protein program led to an increase in quadriceps CSA of 2.3 ± 0.7 cm 2  (P = 0.008) in the dominant leg and 3.2 ± 0.7 cm 2  (P < 0.001) in the non-dominant leg. Isometric quadriceps MVC increased in the dominant leg (Δ14 ± 4 Nm, P = 0.001) and in the non-dominant leg (Δ17 ± 5 Nm, P = 0.003). Chair rise test time improved with -3.8 ± 0.5 s (P < 0.0001), and VO 2 -max improved with 3.3 ± 1.1 ml/min/kg (P = 0.014). We observed no changes in body weight and handgrip strength.
CONCLUSION


A 4-week exercise and protein intervention led to improvements in muscle-related outcomes in older adults with low levels of physical activity.",2020,"Isometric quadriceps MVC increased in the dominant leg (Δ14 ± 4 Nm, P = 0.001) and in the non-dominant leg (Δ17 ± 5 Nm, P = 0.003).","['older adults', 'Seventeen older men and women, aged 55-75y, not scheduled for surgery', 'older adults with low levels of physical activity', 'Dutch older adult population']","['combined exercise and protein supplementation program', 'exercise and protein intervention', 'exercise and protein program', 'intensity aerobic exercise training of 75\u202fmin, combined with daily protein supplementation', 'physical exercise with protein supplementation']","['muscle mass and physical functioning', 'isometric quadriceps maximal voluntary contraction (MVC', 'Isometric quadriceps MVC', 'Chair rise test time', 'VO 2 -max', 'handgrip strength, chair rise time and maximal aerobic capacity (VO 2 -max), as assessed from a submaximal exercise test', 'body weight and handgrip strength']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",17.0,0.0475282,"Isometric quadriceps MVC increased in the dominant leg (Δ14 ± 4 Nm, P = 0.001) and in the non-dominant leg (Δ17 ± 5 Nm, P = 0.003).","[{'ForeName': 'Pol', 'Initials': 'P', 'LastName': 'Grootswagers', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands. Electronic address: pol.grootswagers@wur.nl.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'de Regt', 'Affiliation': 'Department of Physical Therapy, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Jacintha', 'Initials': 'J', 'LastName': 'Domić', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Dronkers', 'Affiliation': 'Department of Physical Therapy, Gelderse Vallei Hospital, Ede, the Netherlands; Research group Innovation and Movement Care, University of Applied Science, Utrecht, the Netherlands.'}, {'ForeName': 'Marlieke', 'Initials': 'M', 'LastName': 'Visser', 'Affiliation': 'Science Office, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Witteman', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands; Department of Physical Therapy, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hopman', 'Affiliation': 'Department of Physiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mensink', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands.'}]",Experimental gerontology,['10.1016/j.exger.2020.111094']
1771,32950645,Rationale and protocol for translating basic habituation research into family-based childhood obesity treatment: Families becoming healthy together study.,"This publication describes the rationale and protocol, including design, aims, intervention, and measures, of Families Becoming Healthy Together, a randomized clinical trial examining the effect of a limited RED (non-nutrient-dense, energy-dense) food variety prescription delivered within an 18-month family-based behavioral obesity treatment (FBT) on body mass index (BMI) and habituation rate to RED foods. One hundred fifty-six children (ages: 8-12 y; BMI: ≥ 85th percentile-for-age) and a caregiver (BMI: ≥ 25 kg/m 2 ), both with overweight or obesity, will be randomized to one of two, interventions: FBT or FBT + Variety. All participants will receive 29 sessions of FBT and be prescribed the Traffic Light Diet (1000-1500 kcal/day, ≤ 2 RED food servings/day), and a physical activity goal (≥ 60 min/day [child] or 150 min/week [adult] of moderate-vigorous physical activity (MVPA)). FBT + Variety will also identify two RED foods, a dinner entrée and snack food, and develop meal plans that reduce variety of RED foods by regularly consuming these foods and limiting consumption of other RED foods. Measures of anthropometrics, dietary intake, habituation of salivary response to food cues, and physical activity will be assessed at 0, 6, 12, and 18-months. This study translates a line of basic behavioral research examining how dietary variety influences habituation into a dietary prescription that will be tested within an efficacy trial. It is hypothesized that a novel, limited dietary variety prescription within FBT should promote a faster food habituation rate, reducing energy intake and amplifying long-term weight loss in children.",2020,One hundred fifty-six children (ages: 8-12,"['family-based childhood obesity treatment', 'One hundred fifty-six children (ages: 8-12', 'y; BMI: ≥ 85th percentile-for-age) and a caregiver (BMI: ≥ 25\u202fkg/m 2 ), both with overweight or obesity', 'children']","['FBT or FBT\u202f+\u202fVariety', 'FBT and be prescribed the Traffic Light Diet', 'physical activity goal (≥ 60\u202fmin/day [child] or 150\u202fmin/week [adult] of moderate-vigorous physical activity (MVPA', 'limited RED (non-nutrient-dense, energy-dense) food variety prescription delivered within an 18-month family-based behavioral obesity treatment (FBT']","['anthropometrics, dietary intake, habituation of salivary response to food cues, and physical activity', 'body mass index (BMI) and habituation rate to RED foods']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332575', 'cui_str': 'Red color'}]",156.0,0.050562,One hundred fifty-six children (ages: 8-12,"[{'ForeName': 'Steve M', 'Initials': 'SM', 'LastName': 'Douglas', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville, TN, USA.'}, {'ForeName': 'Grace M', 'Initials': 'GM', 'LastName': 'Hawkins', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville, TN, USA.'}, {'ForeName': 'Kristoffer S', 'Initials': 'KS', 'LastName': 'Berlin', 'Affiliation': 'Department of Psychology, University of Memphis, Memphis, TN, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Crouter', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies, University of Tennessee, Knoxville, TN, USA.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, School of Medicine, and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital/Brown Alpert Medical School, Providence, RI, USA.'}, {'ForeName': 'Hollie A', 'Initials': 'HA', 'LastName': 'Raynor', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville, TN, USA. Electronic address: hraynor@vols.utk.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106153']
1772,32951754,The effects of eugenol nanoemulsion on pain caused by arteriovenous fistula cannulation in hemodialysis patients: A randomized double-blinded controlled cross-over trial.,,2020,,['hemodialysis patients'],['eugenol nanoemulsion'],['pain'],"[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015153', 'cui_str': 'Eugenol'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.418149,,"[{'ForeName': 'Kamyar', 'Initials': 'K', 'LastName': 'Mansori', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran. Electronic address: kamyarmansori@yahoo.com.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Soltani-Kermanshahi', 'Affiliation': 'Social Determinants of Health Research Center, School of Medicine, Semnan University of Medical Sciences, Semnan, Iran. Electronic address: msoltani@semums.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102506']
1773,32956964,Efficacy of learning through play plus intervention to reduce maternal depression in women with malnourished children: A randomized controlled trial from Pakistan ✰ .,"BACKGROUND


The risk factors and adverse outcomes related to maternal depression and child malnutrition are a leading cause of morbidity and mortality in low and middle-income countries (LMIC) including Pakistan. Above 25% of women suffer from maternal depression. Up to 50% children are under-nourished which contributes to 35% of all under-5 deaths in the country.
AIM


To determine the efficacy of Learning through Play Plus Thinking Healthy Program (LTP Plus) intervention to reduce maternal depression in mothers with undernourished children.
METHODS


In this randomised controlled trial, all eligible mothers presenting to the paediatric departments were invited to participate in the study. Out of the total 256 mothers screened, 107 were included, 54 of those were randomly allocated to LTP Plus group and 53 to treatment as usual (TAU). Edinburgh Postnatal Depression Scale (EPDS) was used to screen for depression. Hamilton Depression Rating Scale (HDRS), Maternal Attachment Inventory (MAI), Social Support Scale (OSLO-3) and the Euro-QoL (EQ-5D) were used to measure the severity of depression, mother-child attachment, level of support and health related quality of life dimensions. Assessments were completed at baseline, end of intervention (3 months from baseline) and at 6 months from baseline.
RESULTS


Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
CONCLUSION


The outcomes of LTP Plus intervention for mothers of malnourished children show promising results in reducing maternal depression and improving child outcomes. A full trial with longer-term outcomes and cost-effectiveness needs to be conducted.",2020,"RESULTS


Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
","['Out of the total 256 mothers screened, 107 were included, 54 of those', 'mothers with undernourished children', 'eligible mothers presenting to the paediatric departments were invited to participate in the study', 'mothers of malnourished children', 'women with malnourished children']","['Learning through Play Plus Thinking Healthy Program (LTP Plus) intervention', 'learning through play plus intervention', 'LTP Plus group and 53 to treatment as usual (TAU', 'LTP Plus intervention']","['Edinburgh Postnatal Depression Scale (EPDS', 'depression (p<0.001), social support', 'maternal depression', 'severity of depression, mother-child attachment, level of support and health related quality of life dimensions', 'maternal depression and improving child outcomes', 'quality of life', 'Hamilton Depression Rating Scale (HDRS), Maternal Attachment Inventory (MAI), Social Support Scale (OSLO-3) and the Euro-QoL (EQ-5D']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0587482', 'cui_str': 'Pediatric department'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0206249', 'cui_str': 'Long-Term Potentiation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1533125', 'cui_str': 'Euro'}]",,0.148806,"RESULTS


Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
","[{'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'University of Manchester United Kingdom; Lancashire Care NHS Foundation Trust. Electronic address: Nusrat.husain@manchester.ac.uk.'}, {'ForeName': 'Tayyeba', 'Initials': 'T', 'LastName': 'Kiran', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Lancashire Care NHS Foundation Trust; Pakistan Institute of Living and Learning.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'University of Liverpool United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Raza-Ur-Rehman', 'Affiliation': 'Dow University of Health Sciences.'}, {'ForeName': 'Qamar', 'Initials': 'Q', 'LastName': 'Saeed', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Shehla', 'Initials': 'S', 'LastName': 'Naeem', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Sami Ul', 'Initials': 'SU', 'LastName': 'Haq', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Farhat', 'Initials': 'F', 'LastName': 'Jaffery', 'Affiliation': 'Karachi Medical and Dental College Pakistan.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'University of Toronto.'}, {'ForeName': 'Farooq', 'Initials': 'F', 'LastName': 'Naeem', 'Affiliation': 'Centre for Addiction & Mental Health, Toronto, Canada.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Chaudhry', 'Affiliation': 'Pakistan Institute of Living and Learning.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.001']
1774,32957034,Landing biomechanics are not immediately altered by a single-dose patellar tendon isometric exercise protocol in male athletes with patellar tendinopathy: A single-blinded randomized cross-over trial.,"OBJECTIVES


To a) determine the acute effects of a single-dose patellar tendon isometric exercise protocol on involved limb landing biomechanics in individuals with patellar tendinopathy and asymptomatic patellar tendon pathology, and b) determine if individuals with patellar tendinopathy demonstrated changes in pain following a single-dose patellar tendon isometric exercise protocol.
DESIGN


Single-blinded randomized cross-over trial.
SETTING


Laboratory; PARTICIPANTS: 28 young male athletes with symptomatic (n = 13, age: 19.62 ± 1.61) and asymptomatic (n = 15, age: 21.13 ± 1.88) patellar tendinopathy.
MAIN OUTCOME MEASURES


Participants completed a single-dose patellar tendon isometric exercise protocol and a sham-TENS protocol, randomized and separated by 7-10 days. Pain-levels during a single-limb decline squat (SLDS) and three-dimensional biomechanics were collected during a double-limb jump-landing task before and after each intervention protocol. A mixed-model repeated measures ANOVA was conducted to compare change scores for all dependent variables.
RESULTS


There were no group × intervention interactions for change in pain (F (1, 26)  = 0.555, p = 0.463). There was one significant group × intervention interaction for vertical ground reaction force (VGRF) (F (1, 26)  = 5.33, p = 0.029). However, post-hoc testing with Bonferroni correction demonstrated no statistical significance for group (SYM: t = -1.679, p = 0.119; ASYM: t = -1.7, p = 0.107) or intervention condition (isometric: t = -2.58, p = 0.016; sham-TENS: 0.72, p = 0.460). There were no further significant group × intervention interactions (p > 0.05).
CONCLUSIONS


A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.",2020,A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.,"['individuals with patellar tendinopathy and asymptomatic patellar tendon pathology, and b) determine if individuals with patellar tendinopathy', '28 young male athletes with symptomatic (n\xa0=\xa013, age: 19.62\xa0±\xa01.61) and asymptomatic (n\xa0=\xa015, age: 21.13\xa0±\xa01.88) patellar tendinopathy', 'male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology', 'male athletes with patellar tendinopathy']","['sham-TENS', 'single-dose patellar tendon isometric exercise protocol', 'single-limb decline squat (SLDS', 'single-dose patellar tendon isometric exercise protocol and a sham-TENS protocol', 'patellar tendon isometric exercise protocol']","['Pain-levels', 'landing biomechanics or pain levels', 'vertical ground reaction force (VGRF', 'limb landing biomechanics', 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191374', 'cui_str': '1.88'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",28.0,0.197403,A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.,"[{'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Pietrosimone', 'Affiliation': 'Doctor of Physical Therapy Division, Department of Orthopedic Surgery, School of Medicine, Duke University, Durham, NC, USA. Electronic address: laura.pietrosimone@duke.edu.'}, {'ForeName': 'J Troy', 'Initials': 'JT', 'LastName': 'Blackburn', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Wikstrom', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Berkoff', 'Affiliation': 'Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Sean I', 'Initials': 'SI', 'LastName': 'Docking', 'Affiliation': 'La Trobe Sports and Exercise Research Centre, LaTrobe University, Bundooram, Australia.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'La Trobe Sports and Exercise Research Centre, LaTrobe University, Bundooram, Australia.'}, {'ForeName': 'Darin A', 'Initials': 'DA', 'LastName': 'Padua', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.09.003']
1775,32957850,"Does it make a difference to be more ""on the same page""? Investigating the role of alliance convergence for outcomes in two different samples.","Objective : To better understand the complexity of dyadic processes, such as the mechanisms of the working alliance, researchers recommend taking advantage of innovations in data analytic procedures when studying the interactions between therapists and patients that are associated with favorable therapeutic outcomes. Inspired by a recent line of alliance research using dyadic multilevel modeling, the present study investigated the hypothesis that convergence in the patient-therapist working alliance (i.e., increased similarity in ratings of the alliance across treatment) would be associated with better outcomes.  Method : Data were retrieved from two samples: 1. A randomized controlled trial for treatment resistant depression ( N  = 96 dyads), and 2. An archival dataset of naturalistic psychotherapies from public health care ( N  = 139 dyads). Multilevel growth curve analysis was employed to investigate the degree of change in session-to-session agreement of global WAI ratings between therapists and patients (i.e., alliance convergence) as a predictor of symptom reduction in the BDI-II and the SCL-90R.  Results : Contrary to our expectations, alliance convergence did not predict outcome in either sample, but was negatively associated with symptom severity in Study 2. Implications for understanding the complexity of dyadic processes and alliance work in psychotherapy are discussed.",2020,"Contrary to our expectations, alliance convergence did not predict outcome in either sample, but was negatively associated with symptom severity in Study 2.",['public health care ( N \u2009=\u2009139 dyads'],[],[],"[{'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C5191072', 'cui_str': '139'}]",[],[],139.0,0.0484727,"Contrary to our expectations, alliance convergence did not predict outcome in either sample, but was negatively associated with symptom severity in Study 2.","[{'ForeName': 'Helene A', 'Initials': 'HA', 'LastName': 'Nissen-Lie', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ole André', 'Initials': 'OA', 'LastName': 'Solbakken', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Falkenström', 'Affiliation': 'Department of Behavioral Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Wampold', 'Affiliation': 'University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Holmqvist', 'Affiliation': 'Department of Behavioral Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Ekeblad', 'Affiliation': 'Department of Behavioral Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Jon T', 'Initials': 'JT', 'LastName': 'Monsen', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1823030']
1776,32960408,Early Tumor Shrinkage and Depth of Response in the Second-Line Treatment for KRAS exon2 Wild-Type Metastatic Colorectal Cancer: An Exploratory Analysis of the Randomized Phase 2 Trial Comparing Panitumumab and Bevacizumab in Combination with FOLFIRI (WJOG6210G).,"BACKGROUND


Predictive markers for the clinical outcomes of second-line treatment in patients with metastatic colorectal cancer (mCRC) remain unclear.
OBJECTIVE


This retrospective biomarker study was conducted to explore predictive markers for patients with KRAS exon 2 wild-type mCRC who were treated with FOLFIRI plus panitumumab (Pani) or bevacizumab (Bev) in the WJOG6210G trial.
PATIENTS AND METHODS


The associations of early tumor shrinkage (ETS), tumor location, and VEGF-D with progression-free survival (PFS) and overall survival (OS) were analyzed using a Cox proportional hazards model. Spearman's correlation coefficient was used to analyze the association of depth of response (DpR) with PFS and OS. Serum VEGF-D levels were measured in samples collected before treatment using magnetic bead panel Milliplex xMAP kits.
RESULTS


In total, 101 patients (Pani, n = 49; Bev, n = 52) were enrolled in this study. Patients with ETS had longer PFS (Pani: hazard ratio (HR) 0.40, P = 0.009; Bev: HR 0.078, P = 0.0002) and OS (Pani: HR 0.49, P = 0.044; Bev: HR 0.35, P = 0.048) than patients without ETS. The DpR was moderately correlated with PFS and OS in Pani (rs = 0.75, P < 0.001; rs = 0.60, P < 0.001) and Bev groups (rs = 0.68, P < 0.001; rs = 0.44, P = 0.002). No significant differences were observed in PFS and OS between the two treatment groups even if in left-sided tumors. No significant interaction between VEGF-D levels and treatment was observed in PFS and OS.
CONCLUSIONS


ETS and DpR serve as surrogate markers of PFS and OS in the second-line treatment with FOLFIRI plus targeted agent for mCRC.",2020,"Patients with ETS had longer PFS (Pani: hazard ratio (HR) 0.40, P = 0.009; Bev: HR 0.078, P = 0.0002) and OS (Pani: HR 0.49, P = 0.044; Bev: HR 0.35, P = 0.048) than patients without ETS.","['patients with metastatic colorectal cancer (mCRC', 'patients with KRAS exon 2 wild-type mCRC who were treated with', 'KRAS exon2 Wild-Type Metastatic Colorectal Cancer', '101 patients (Pani, n\u2009=\u200949; Bev, n\u2009=\u200952']","['Panitumumab and Bevacizumab', 'FOLFIRI plus panitumumab (Pani) or bevacizumab (Bev']","['early tumor shrinkage (ETS), tumor location, and VEGF-D with progression-free survival (PFS) and overall survival (OS', 'longer PFS', 'PFS and OS', 'Early Tumor Shrinkage and Depth of Response', 'VEGF-D levels', 'Serum VEGF-D levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0664390', 'cui_str': 'Vascular Endothelial Growth Factor-D'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",101.0,0.0754459,"Patients with ETS had longer PFS (Pani: hazard ratio (HR) 0.40, P = 0.009; Bev: HR 0.078, P = 0.0002) and OS (Pani: HR 0.49, P = 0.044; Bev: HR 0.35, P = 0.048) than patients without ETS.","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Izawa', 'Affiliation': 'Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Kimio', 'Initials': 'K', 'LastName': 'Yonesaka', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Sunakawa', 'Affiliation': 'Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Masuishi', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Tadamichi', 'Initials': 'T', 'LastName': 'Denda', 'Affiliation': 'Department of Gastroenterology, Chiba Cancer Center Hospital, Chiba, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shimonagakubo, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Moriwaki', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okuda', 'Affiliation': 'Department of Medical Oncology, Keiyukai Sapporo Hospital, Sapporo, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Kondoh', 'Affiliation': 'Department of Medical Oncology, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Nishina', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Akitaka', 'Initials': 'A', 'LastName': 'Makiyama', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Kita-Kyushu, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Gastrointestinal Surgery, Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Aizawa Comprehensive Cancer Center, Aizawa Hospital, Matsumoto, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Takako Eguchi', 'Initials': 'TE', 'LastName': 'Nakajima', 'Affiliation': 'Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan. tnakajima@kuhp.kyoto-u.ac.jp.'}]",Targeted oncology,['10.1007/s11523-020-00750-w']
1777,32965227,Optimizing an Acceptance and Commitment Therapy Microintervention Via a Mobile App With Two Cohorts: Protocol for Micro-Randomized Trials.,"BACKGROUND


Given gaps in the treatment of mental health, brief adaptive interventions have become a public health imperative. Transdiagnostic interventions may be particularly appropriate given high rates of medical comorbidity and the broader reach of transdiagnostic therapies. One such approach utilized herein is acceptance and commitment therapy (ACT), which is focused on increasing engagement with values, awareness, and openness to internal experiences. ACT theory posits that experiential avoidance is at the center of human suffering, regardless of diagnosis, and, as such, seeks to reduce unworkable experiential avoidance.
OBJECTIVE


Our objective is to provide the rationale and protocol for examining the safety, feasibility, and effectiveness of optimizing an ACT-based intervention via a mobile app among two disparate samples, which differ in sociodemographic characteristics and symptom profiles.
METHODS


Twice each day, participants are prompted via a mobile app to complete assessments of mood and activity and are then randomly assigned to an ACT-based intervention or not. These interventions are questions regarding engagement with values, awareness, and openness to internal experiences. Participant responses are recorded. Analyses will examine completion of assessments, change in symptoms from baseline assessment, and proximal change in mood and activity. A primary outcome of interest is proximal change in activity (eg, form and function of behavior and energy consumed by avoidance and values-based behavior) following interventions as a function of time, symptoms, and behavior, where we hypothesize that participants will focus more energy on values-based behaviors. Analyses will be conducted using a weighted and centered least squares approach. Two samples will run concurrently to assess the capacity of optimizing mobile ACT in populations that differ widely in their clinical presentation and sociodemographic characteristics: individuals with bipolar disorder (n=30) and distressed first-generation college students (n=50).
RESULTS


Recruitment began on September 10, 2019, for the bipolar sample and on October 5, 2019, for the college sample. Participation in the study began on October 18, 2019.
CONCLUSIONS


This study examines an ACT-based intervention among two disparate samples. Should ACT demonstrate feasibility and preliminary effectiveness in each sample, a large randomized controlled trial applying ACT across diagnoses and demographics would be indicated. The public health implications of such an approach may be far-reaching.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04098497; https://clinicaltrials.gov/ct2/show/NCT04098497; ClinicalTrials.gov NCT04081662; https://clinicaltrials.gov/ct2/show/NCT04081662.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17086.",2020,"Two samples will run concurrently to assess the capacity of optimizing mobile ACT in populations that differ widely in their clinical presentation and sociodemographic characteristics: individuals with bipolar disorder (n=30) and distressed first-generation college students (n=50).
",['sociodemographic characteristics: individuals with bipolar disorder (n=30) and distressed first-generation college students (n=50'],['ACT-based intervention or not'],"['proximal change in activity (eg, form and function of behavior and energy consumed by avoidance and values-based behavior) following interventions as a function of time, symptoms, and behavior']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",2.0,0.264177,"Two samples will run concurrently to assess the capacity of optimizing mobile ACT in populations that differ widely in their clinical presentation and sociodemographic characteristics: individuals with bipolar disorder (n=30) and distressed first-generation college students (n=50).
","[{'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': 'Kroska', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Hoel', 'Affiliation': 'Department of Psychiatry, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Victory', 'Affiliation': 'Department of Psychiatry, University of Michigan-Ann Arbor, Ann Arbor, MI, United States.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': 'Department of Statistics, Harvard University, Cambridge, MA, United States.'}, {'ForeName': 'Melvin G', 'Initials': 'MG', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan-Ann Arbor, Ann Arbor, MI, United States.'}, {'ForeName': 'Zachary N', 'Initials': 'ZN', 'LastName': 'Stowe', 'Affiliation': 'Department of Psychiatry, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cochran', 'Affiliation': 'Department of Population Health Sciences, University of Wisconsin-Madison, Madison, WI, United States.'}]",JMIR research protocols,['10.2196/17086']
1778,32965539,"A placebo-controlled, double-blind, randomized study of recombinant thrombomodulin (ART-123) to prevent oxaliplatin-induced peripheral neuropathy.","PURPOSE


The purpose of this clinical study was to be the first to explore whether ART-123, a recombinant human soluble thrombomodulin, prevents oxaliplatin-induced peripheral neuropathy (OIPN).
METHODS


This randomized, phase IIa trial enrolled stage II/III colon cancer patients who received adjuvant mFOLFOX6 chemotherapy. Participants were randomly allocated to 3 arms in a double-blind manner: placebo (placebo: days 1-3); 1-day ART (ART-123: day 1, placebo: days 2-3); and 3-day ART (ART-123: days 1-3). ART-123 (380 U/kg/day) or placebo was infused intravenously before each 2-week cycle of mFOLFOX6. OIPN was assessed with the Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 (FACT/GOG-Ntx-12) score by participants and the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) by investigators.
RESULTS


Seventy-nine participants (placebo n = 28, 1-day ART n = 27, 3-day ART n = 24) received study drugs. The least-squares mean FACT/GOG-Ntx-12 scores at cycle 12 from the mixed effect model for repeated measures were 28.9 with placebo, 36.3 with 1-day ART (vs. placebo: 7.3 [95% CI 1.9 to12.8, p = 0.009]), and 32.3 with 3-day ART (vs. placebo: 3.4 [95% CI -.1 to 9.0, p = 0.222]). The cumulative incidence of NCI-CTCAE grade ≥ 2 sensory neuropathy at cycle 12 was 64.3% with placebo, 40.7% with 1-day ART (vs. placebo: -23.5 [95% CI -48.4 to 4.0], p = 0.108), and 45.8% with 3-day ART (vs. placebo: -18.5 [95% CI -44.2 to 9.4], p = 0.264). Common adverse events were consistent with those reported with mFOLFOX6; no severe bleeding adverse events occurred.
CONCLUSION


ART-123 showed a potential preventive effect against OIPN with good tolerability. A larger study with 1-day ART is warranted. NCT02792842, registration date: June 8, 2016.",2020,"The cumulative incidence of NCI-CTCAE grade ≥ 2 sensory neuropathy at cycle 12 was 64.3% with placebo, 40.7% with 1-day ART (vs. placebo: -23.5","['Seventy-nine participants (placebo n\u2009=\u200928, 1-day ART n\u2009=\u200927, 3-day ART n\u2009=\u200924) received study drugs', 'III colon cancer patients who received']","['ART-123', 'placebo', 'recombinant thrombomodulin (ART-123', 'adjuvant mFOLFOX6 chemotherapy', 'placebo (placebo: days 1-3); 1-day ART (ART-123: day 1, placebo']","['OIPN', 'severe bleeding adverse events', 'Neurotoxicity-12 (FACT/GOG-Ntx-12) score', 'cumulative incidence of NCI-CTCAE grade\u2009≥\u20092 sensory neuropathy']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1174887', 'cui_str': 'ART123'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0560007', 'cui_str': 'nCi'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}]",,0.727589,"The cumulative incidence of NCI-CTCAE grade ≥ 2 sensory neuropathy at cycle 12 was 64.3% with placebo, 40.7% with 1-day ART (vs. placebo: -23.5","[{'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Kotaka', 'Affiliation': 'Gastrointestinal Cancer Center, Sano Hospital, 2-5-1 Shimizugaoka, Tarumi-ku, Kobe-shi, Hyogo, 655-0031, Japan. tomomakotaka6410@yahoo.co.jp.'}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Anesthesiology, Shimane University Faculty of Medicine, 89-1 Enyacho, Izumo City, Shimane, 693-8501, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterological Surgery, Kansai Rosai Hospital, 3-1-69 Inabaso, Amagasaki-shi, Hyogo, 660-8511, Japan.'}, {'ForeName': 'Hironaga', 'Initials': 'H', 'LastName': 'Satake', 'Affiliation': 'Department of Medical Oncology, Kobe City Medical Center General Hospital, 2-1-1 Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047, Japan.'}, {'ForeName': 'Akitaka', 'Initials': 'A', 'LastName': 'Makiyama', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, 1-8-1 Kishinoura, Yahatanishi-ku, Kitakyusyu-shi, Fukuoka, 806-8501, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tsuji', 'Affiliation': 'Department of Medical Oncology, Tonan Hospital, Kita 4-jo Nishi 7-chome 3-8, Chuo-ku, Sapporo-shi, Hokkaido, 060-0004, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Division of Clinical Oncology, Hiroshima Prefectural Hospital, 1-5-54 Ujinakanda, Minami-ku, Hiroshima-shi, Hiroshima, 734-8530, Japan.'}, {'ForeName': 'Toshiyoshi', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan.'}, {'ForeName': 'Tsunekazu', 'Initials': 'T', 'LastName': 'Mizushima', 'Affiliation': 'Department of Gastrointestinal Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Harihara', 'Affiliation': 'Department of Surgery, NTT Medical Center Tokyo, 5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo, 141-8625, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Nagata', 'Affiliation': 'Department of Surgery, Kitakyushu General Hospital, 1-1 Higashijono-machi, Kokurakita-ku, Kitakyushu, 802-8517, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Kurihara', 'Affiliation': 'Department of Surgery, Nerima General Hospital, 1-24-1 Asahigaoka, Nerima-ku, Tokyo, 176-8530, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Japan.'}, {'ForeName': 'Genichi', 'Initials': 'G', 'LastName': 'Kusakawa', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Sakai', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Yugo', 'Initials': 'Y', 'LastName': 'Uchida', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Mikihiro', 'Initials': 'M', 'LastName': 'Takamoto', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Kimoto', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04135-8']
1779,32965585,Rationale and Design of the H-REPLACE Study: Safety and Efficacy of LMWH Versus Rivaroxaban in ChinEse Patients HospitaLized with Acute Coronary SyndromE.,"BACKGROUND


Acute coronary syndrome (ACS) is a serious and life-threatening condition. Anticoagulation during the acute phase of ACS is effective in reducing ischemic events. The most widely used parenteral anticoagulation agent in ACS patients is enoxaparin. Rivaroxaban is a novel oral anticoagulant with potent anti-Xa activity, which might be an attractive alternative drug to enoxaparin. In fact, rivaroxaban was consistently shown to be non-inferior to enoxaparin therapy in terms of reduction of recurrent venous thromboembolism events.
OBJECTIVE


This prospective, randomized, open-label, active-controlled, multicenter study is designed to compare the safety and efficacy of rivaroxaban versus enoxaparin in patients with ACS, who missed the primary reperfusion therapy window and before selective revascularization.
METHODS AND RESULTS


Up to 2055 participants receiving background treatment of aspirin plus clopidogrel or ticagrelor will be randomly assigned to either oral rivaroxaban 2.5 mg twice daily or rivaroxaban 5 mg twice daily or subcutaneous enoxaparin 1 mg/kg twice daily until hospital discharge for a maximum of 8 days or 12 h before revascularization therapy. The primary safety endpoint is the International Society on Thrombosis and Hemostasis definition of bleeding events [minor, clinically relevant non-major and major bleeding]. The primary efficacy endpoint is a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction, re-revascularization or stroke, and major bleeding events. Secondary endpoints include cardiac-related rehospitalization and all-cause death. Patients will be followed for 12 months after randomization.
CONCLUSIONS


The H-REPLACE trial offers an opportunity to assess clinical outcomes of rivaroxaban versus enoxaparin during the acute phase of ACS and may provide an alternative anticoagulation strategy for ACS patients, who missed the primary reperfusion therapy window and before selective revascularization.
TRIAL REGISTRATION


ClinicalTrials.gov; NCT03363035.",2020,"The primary efficacy endpoint is a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction, re-revascularization or stroke, and major bleeding events.","['ChinEse Patients HospitaLized with Acute Coronary SyndromE', '2055 participants receiving background treatment of', 'patients with ACS, who missed the primary reperfusion therapy window and before selective revascularization']","['rivaroxaban', 'LMWH Versus Rivaroxaban', 'aspirin plus clopidogrel or ticagrelor', 'Rivaroxaban', '5\xa0mg twice daily or subcutaneous', 'oral rivaroxaban 2.5\xa0mg twice daily or rivaroxaban', 'enoxaparin']","['International Society on Thrombosis and Hemostasis definition of bleeding events [minor, clinically relevant non-major and major bleeding', 'cardiac-related rehospitalization and all-cause death', 'safety and efficacy', 'ischemic events', 'composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction, re-revascularization or stroke, and major bleeding events']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4731644', 'cui_str': 'rivaroxaban 2.5 MG'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}]","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",2055.0,0.0643077,"The primary efficacy endpoint is a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction, re-revascularization or stroke, and major bleeding events.","[{'ForeName': 'Yichao', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': ""Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, People's Republic of China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, People's Republic of China.""}, {'ForeName': 'Qiming', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, People's Republic of China.""}, {'ForeName': 'Xinqun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, People's Republic of China.""}, {'ForeName': 'Zhenfei', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': ""Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, People's Republic of China.""}, {'ForeName': 'Shenghua', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': ""Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, People's Republic of China. zhoushenghua@csu.edu.cn.""}]",Cardiovascular drugs and therapy,['10.1007/s10557-020-07076-9']
1780,32961360,COVID-19 hits a trial: Arguments against hastily deviating from the plan.,"The COVID-19 pandemic has substantially impacted the conduct of clinical trials. While initially preparing for a period of time, where it would likely be impossible to supervise trials in the usual way and precautionary measures had to be implemented to care for medication supply and general safety of study participants it is now important to consider, how the impact of the pandemic on trial outcome can be assessed, which measures are needed to decide, how to proceed with the trial and what is needed to compensate to irregularity introduced by the pandemic situation. Obviously not all trials will suffer to the same degree: some trials may be close to finalizing recruitment, others may not yet have started. Similarly not all clinical trials investigate vulnerable patient populations, but some will and may in addition have recruited to an extent that beneficial effects achieved in the initial phase of the trial may be outweighed by an increase e.g. in mortality that impacts both treatment groups. The situation is further complicated by the fact that the pandemic reached different countries in the world and even cities in one country at different points in time with different severity. Our example is a randomized and double-blind clinical trial comparing digitoxin and placebo in patients with advanced chronic heart failure. This trial has recruited roughly 1/3 of the overall 2200 patients when the disease outbreak reached Germany. We discuss how simulations and theoretical considerations can be used to address questions about the need to increase the overall sample-size to be recruited to compensate for a potential shrinkage of the treatment effect caused by the COVID-19 pandemic and what role the degree of consistency could play when comparing pre-, during- and post- COVID-19 periods of trial conduct regarding the question, whether the treatment effect can be considered consistent and with this generalizable. This is dependent on the size of the treatment effect and the impact of the pandemic. We argue, that in case of doubt, it may be wise to proceed with the original study plan.",2020,"We discuss how simulations and theoretical considerations can be used to address questions about the need to increase the overall sample-size to be recruited to compensate for a potential shrinkage of the treatment effect caused by the COVID-19 pandemic and what role the degree of consistency could play when comparing pre-, during- and post-","['patients with advanced chronic heart failure', '2400 patients when the disease outbreak reached Germany']",['digitoxin and placebo'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0012652', 'cui_str': 'Disease outbreak'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0012258', 'cui_str': 'Digitoxin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],2400.0,0.116561,"We discuss how simulations and theoretical considerations can be used to address questions about the need to increase the overall sample-size to be recruited to compensate for a potential shrinkage of the treatment effect caused by the COVID-19 pandemic and what role the degree of consistency could play when comparing pre-, during- and post-","[{'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Großhennig', 'Affiliation': 'Institut für Biometrie, Medizinische Hochschule Hannover, Germany. Electronic address: grosshennig.anika@mh-hannover.de.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Institut für Biometrie, Medizinische Hochschule Hannover, Germany. Electronic address: koch.armin@mh-hannover.de.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106155']
1781,32961410,Intranasal oxytocin and the stress-buffering effects of social support during experimentally induced pain: The role of attachment security.,"BACKGROUND


This study examined whether intranasal oxytocin enhances the stress-buffering effects of social support during experimentally induced pain, taking into account the role of individual differences in attachment security.
METHODS


Female participants (N = 193) were randomly assigned to oxytocin (24 IU intranasal) or placebo and to receive support or no support from a friend (2 × 2 factorial design with repeated measures)). Participants underwent the Cold Pressor Task (CPT) and were monitored for heart rate variability (HRV: RMSSD) and heart rate and reported pain levels. The Experiences in Close Relationships Questionnaire was used to measure attachment.
RESULTS


Oxytocin reduced RMSSD (p = 0.003, partial ɳ 2  = 0.03) and increased heart rate (p = 0.039, partial ɳ 2  = 0.03) in individuals who received support, possibly reflecting an enhanced attentional state. Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06).
LIMITATIONS


Only female participants were examined. Future studies are needed to determine sex differences in how oxytocin shapes stress-buffering effects of support.
CONCLUSIONS


Oxytocin may enhance the salience of social proximity and may be a mechanism underlying previously reported social influences on cardiovascular and mental health. However, oxytocin effects depend on interpersonal insecurities and may trigger discomfort in avoidantly attached individuals. Caution about oxytocin's therapeutic promise is warranted.",2020,"Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06).
","['Only female participants', 'Female participants (N\xa0=\xa0193']","['intranasal oxytocin', 'oxytocin', 'placebo and to receive support or no support from a friend', 'Oxytocin', 'Cold Pressor Task (CPT', 'Intranasal oxytocin']","['heart rate variability (HRV: RMSSD) and heart rate and reported pain levels', 'pain intensity', 'RMSSD', 'heart rate', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",193.0,0.159338,"Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06).
","[{'ForeName': 'M M E', 'Initials': 'MME', 'LastName': 'Riem', 'Affiliation': 'Behavioural Science Institute, Radboud University, The Netherlands; Department of Clinical Child and Family Studies, VU University, Amsterdam, The Netherlands. Electronic address: m.riem@psych.ru.nl.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Kunst', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands; Mentaal Beter, Breda, The Netherlands. Electronic address: L.E.Kunst@tilburguniversity.edu.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Kop', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands. Electronic address: W.J.Kop@tilburguniversity.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.057']
1782,32961445,"Patient-reported outcomes with first-line durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): a randomized, controlled, open-label, phase III study.","OBJECTIVES


In the phase III CASPIAN study, first-line durvalumab plus etoposide in combination with either cisplatin or carboplatin (EP) significantly improved overall survival (primary endpoint) versus EP alone in patients with extensive-stage small-cell lung cancer (ES-SCLC) at the interim analysis. Here we report patient-reported outcomes (PROs).
MATERIALS AND METHODS


Treatment-naïve patients with ES-SCLC received 4 cycles of durvalumab plus EP every 3 weeks followed by maintenance durvalumab every 4 weeks until progression, or up to 6 cycles of EP every 3 weeks. PROs, assessed with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) version 3 and its lung cancer module, the Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13), were prespecified secondary endpoints. Changes from baseline to disease progression or 12 months in prespecified key disease-related symptoms (cough, dyspnea, chest pain, fatigue, appetite loss) were analyzed with a mixed model for repeated measures. Time to deterioration (TTD) of symptoms, functioning, and global health status/quality of life (QoL) from randomization was analyzed.
RESULTS


In the durvalumab plus EP and EP arms, 261 and 260 patients were PRO-evaluable. Patients in both arms experienced numerically reduced symptom burden over 12 months or until progression for key symptoms. For the improvements from baseline in appetite loss, the between-arm difference was statistically significant, favoring durvalumab plus EP (difference, -4.5; 99% CI: -9.04, -0.04; nominal p = 0.009). Patients experienced longer TTD with durvalumab plus EP versus EP for all symptoms (hazard ratio [95% CI] for key symptoms: cough 0.78 [0.600‒1.026]; dyspnea 0.79 [0.625‒1.006]; chest pain 0.76 [0.575‒0.996]; fatigue 0.82 [0.653‒1.027]; appetite loss 0.70 [0.542‒0.899]), functioning, and global health status/QoL.
CONCLUSION


Addition of durvalumab to first-line EP maintained QoL and delayed worsening of patient-reported symptoms, functioning, and global health status/QoL compared with EP.",2020,"For the improvements from baseline in appetite loss, the between-arm difference was statistically significant, favoring durvalumab plus EP (difference, -4.5; 99% CI: -9.04, -0.04; nominal p = 0.009).","['Treatment-naïve patients with ES-SCLC received 4 cycles of', 'patients with extensive-stage small-cell lung cancer (ES-SCLC', 'extensive-stage small-cell lung cancer (CASPIAN']","['first-line durvalumab plus platinum-etoposide versus platinum-etoposide', 'cisplatin or carboplatin (EP', 'EP alone', 'durvalumab plus EP']","['appetite loss 0.70 [0.542‒0.899]), functioning, and global health status/QoL.\nCONCLUSION\n\n\nAddition of durvalumab to first-line EP maintained QoL and delayed worsening of patient-reported symptoms, functioning, and global health status/QoL', 'Quality of Life Questionnaire-Core 30 (QLQ-C30) version 3 and its lung cancer module, the Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13', 'Cancer (EORTC', 'appetite loss', 'chest pain 0.76', 'symptom burden', 'symptoms (cough, dyspnea, chest pain, fatigue, appetite loss', 'overall survival', 'Time to deterioration (TTD) of symptoms, functioning, and global health status/quality of life (QoL']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.142705,"For the improvements from baseline in appetite loss, the between-arm difference was statistically significant, favoring durvalumab plus EP (difference, -4.5; 99% CI: -9.04, -0.04; nominal p = 0.009).","[{'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Goldman', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. Electronic address: jwgoldman@mednet.ucla.edu.'}, {'ForeName': 'Marina Chiara', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Yuanbin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Cancer & Hematology Centers of Western Michigan, Grand Rapids, MI, USA.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Dvorkin', 'Affiliation': 'BHI of Omsk Region Clinical Oncology Dispensary, Omsk, Russia.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Trukhin', 'Affiliation': 'Odessa National Medical University, Odessa, Ukraine.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Statsenko', 'Affiliation': 'Omsk Regional Cancer Center, Omsk, Russian Federation.'}, {'ForeName': 'Katsuyuki', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Ji', 'Affiliation': 'Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea.'}, {'ForeName': 'Maximilian J', 'Initials': 'MJ', 'LastName': 'Hochmair', 'Affiliation': 'Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna, Austria.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Voitko', 'Affiliation': 'Kyiv City Clinical Oncological Centre, Kiev, Ukraine.'}, {'ForeName': 'Libor', 'Initials': 'L', 'LastName': 'Havel', 'Affiliation': 'Thomayer Hospital, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Artem', 'Initials': 'A', 'LastName': 'Poltoratskiy', 'Affiliation': 'Petrov Research Institute of Oncology, St Petersburg, Russian Federation.'}, {'ForeName': 'György', 'Initials': 'G', 'LastName': 'Losonczy', 'Affiliation': 'Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Reinmuth', 'Affiliation': 'Asklepios Lung Clinic, Munich-Gauting, Germany.'}, {'ForeName': 'Nikunj', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Laud', 'Affiliation': 'Statistical Services Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Norah', 'Initials': 'N', 'LastName': 'Shire', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Haiyi', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Hospital Universitario 12 de Octubre, H120-CNIO Lung Cancer Unit, Universidad Complutense and Ciberonc, Madrid, Spain.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.09.003']
1783,32961500,One-day Acceptance and Commitment Therapy workshop for preventing persistent post-surgical pain and dysfunction in at-risk veterans: A randomized controlled trial protocol.,"OBJECTIVE


Persistent post-surgical pain is common among patients undergoing surgery, is detrimental to patients' quality of life, and can precipitate long-term opioid use. The purpose of this randomized controlled trial is to assess the effects of a behavioral intervention offered prior to surgery for patients at risk for poor post-surgical outcomes, including persistent pain and impaired functioning.
METHODS


Described herein is an ongoing randomized, patient- and assessor-blind, attention-controlled multisite clinical trial. Four hundred and thirty Veterans indicated for total knee arthroplasty (TKA) with distress and/or pain will be recruited for this study. Participants will be randomly assigned to a one-day (~5 h) Acceptance and Commitment Therapy workshop or one-day education and attention control workshop. Approximately two weeks following their TKA surgery, patients receive an individualized booster session via phone. Following their TKA, patients complete assessments at 1 week, 6 weeks, 3 months, and 6 months.
RESULTS


The primary outcomes are pain intensity and knee-specific functioning; secondary outcomes are symptoms of distress and coping skills. Mediation analyses will examine whether changes in symptoms of distress and coping skills have an impact on pain and functioning at 6 months in Veterans receiving ACT. This study is conducted mostly with older Veterans; therefore, results may not generalize to women and younger adults who are underrepresented in this veteran population.
CONCLUSIONS


The results of this study will provide the first evidence from a large-scale, patient- and assessor-blind controlled trial on the effectiveness of a brief behavioral intervention for the prevention of persistent post-surgical pain and dysfunction.",2020,Mediation analyses will examine whether changes in symptoms of distress and coping skills have an impact on pain and functioning at 6 months in Veterans receiving ACT.,"['patients undergoing surgery', 'older Veterans', 'patients at risk for poor post-surgical outcomes, including persistent pain and impaired functioning', 'Four hundred and thirty Veterans', 'at-risk veterans', 'women and younger adults who are underrepresented in this veteran population']","['Acceptance and Commitment Therapy workshop or one-day education and attention control workshop', 'behavioral intervention']","['pain intensity and knee-specific functioning; secondary outcomes are symptoms of distress and coping skills', 'total knee arthroplasty (TKA) with distress and/or pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",430.0,0.299537,Mediation analyses will examine whether changes in symptoms of distress and coping skills have an impact on pain and functioning at 6 months in Veterans receiving ACT.,"[{'ForeName': 'McKenzie K', 'Initials': 'MK', 'LastName': 'Roddy', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States of America.'}, {'ForeName': 'Derrecka M', 'Initials': 'DM', 'LastName': 'Boykin', 'Affiliation': 'South Central Mental Illness, Research and Clinical Center, Michael E. DeBakey VA Medical Center, Houston, TX, United States of America.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hadlandsmyth', 'Affiliation': 'Department of Anesthesia, Carver College of Medicine, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Marchman', 'Affiliation': 'Department of Psychology, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Green', 'Affiliation': 'Michael E. DeBakey Veteran Affairs Medical Center, Houston, TX, United States of America.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Buckwalter', 'Affiliation': 'Department of Orthopedics and Rehabilitation, Carver College of Medicine, University of Iowa, United States of America.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Garvin', 'Affiliation': 'Department of Psychiatry, University of Iowa Hospitals and Clinics, Iowa City, IA, United States of America.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Zimmerman', 'Affiliation': 'College of Public Health, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Jaewon', 'Initials': 'J', 'LastName': 'Bae', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Cortesi', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Merlyn', 'Initials': 'M', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, TX, United States of America.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Embree', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Rakel', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, United States of America. Electronic address: barbara-rakel@uiowa.edu.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Dindo', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, TX, United States of America; Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, United States of America. Electronic address: lilian.dindo@bcm.edu.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110250']
1784,32974043,Assessing the acceptability of a text messaging service and smartphone app to support patient adherence to medications prescribed for high blood pressure: a pilot study.,"Aims and objectives


This paper describes a pilot non-randomised controlled study of a highly tailored 56-day text messaging and smartphone app prototype intervention to increase adherence to anti-hypertensive medication in primary care. The aim of this study was to evaluate the acceptability of the intervention and obtain patients' views about the intervention content, the delivery mode, and the mechanisms by which the intervention supported medication adherence.
Methods


Patients diagnosed with hypertension were invited and recruited to the study via general practice text messages and attended a face to face meeting with a member of the researcher team. Participants were asked to test the text messaging intervention for 28 consecutive days and switch to the smartphone app for 28 more days. Participants completed baseline and follow-up questionnaires and took part in semi-structured telephone interviews. Digital log files captured patients' engagement with the intervention. Participant transcripts were analysed using thematic analysis. Descriptive statistics were used to summarise data from questionnaires and log files. A mixed methods analysis generated data to respond to the research questions.
Results


Seventy-nine patients expressed interest to participate in this study, of whom 23 (64% male, 82% above 60 years old) were registered to take part. With one drop-out, 22 participants tested the text messaging delivery mode (with 20 being interviewed) and four of them (17%) switched to the app (with 3 being interviewed). All participants engaged and interacted with the text messages and app notifications, and all participants found the intervention content and delivery mode acceptable. They also self-reported that the interactive elements of the intervention motivated them to take their medications as prescribed.
Conclusion


This study provides evidence that the digital intervention is acceptable by hypertensive patients recruited in primary care. Future research could usefully investigate its feasibility and effectiveness using rigorous research methods.
Trial registration


ISRCTN12805654.",2020,"All participants engaged and interacted with the text messages and app notifications, and all participants found the intervention content and delivery mode acceptable.","['Patients diagnosed with hypertension were invited and recruited\xa0to the study via general practice text messages and attended a\xa0face to face meeting with a member of\xa0the researcher team', '22 participants tested the text\xa0messaging delivery mode (with 20 being interviewed) and four of them (17%) switched to the app (with 3 being interviewed', 'Seventy-nine patients expressed interest to participate in this study, of whom 23 (64% male, 82% above 60\u2009years old', 'primary care', 'hypertensive patients recruited in primary care']","['digital intervention', 'text\xa0messaging intervention', 'smartphone app prototype intervention']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]",[],22.0,0.0448086,"All participants engaged and interacted with the text messages and app notifications, and all participants found the intervention content and delivery mode acceptable.","[{'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Kassavou', 'Affiliation': 'Department of Public Health and Primary Care, The Primary Care Unit, Behavioural Science Group, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Charlotte Emily', 'Initials': 'CE', 'LastName': ""A'Court"", 'Affiliation': 'Department of Public Health and Primary Care, The Primary Care Unit, Behavioural Science Group, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Jagmohan', 'Initials': 'J', 'LastName': 'Chauhan', 'Affiliation': 'Department of Computer Science and Technology, Mobile Systems Group, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'James David', 'Initials': 'JD', 'LastName': 'Brimocombe', 'Affiliation': 'Department of Public Health and Primary Care, The Primary Care Unit, Behavioural Science Group, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Debi', 'Initials': 'D', 'LastName': 'Bhattacharya', 'Affiliation': 'School of Pharmacy, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Naughton', 'Affiliation': 'School of Health Science, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hardeman', 'Affiliation': 'School of Health Science, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Mascolo', 'Affiliation': 'Department of Computer Science and Technology, Mobile Systems Group, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'Department of Public Health and Primary Care, The Primary Care Unit, Behavioural Science Group, University of Cambridge, Cambridge, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00666-2']
1785,32965395,"Rationale and design of the ""Tocilizumab in patients with moderate to severe COVID-19: an open-label multicentre randomized controlled"" trial (TOCIBRAS).","INTRODUCTION


Pro-inflammatory markers play a significant role in the disease severity of patients with COVID-19. Thus, anti-inflammatory therapies are attractive agents for potentially combating the uncontrolled inflammatory cascade in these patients. We designed a trial testing tocilizumab versus standard of care intending to improve the outcomes by inhibiting interleukin-6, an important inflammatory mediator in COVID-19.
METHODS AND ANALYSIS


This open-label multicentre randomized controlled trial will compare clinical outcomes of tocilizumab plus standard of care versus standard of care alone in patients with moderate to severe COVID-19. Two of the following four criteria are required for protocol enrolment: D-dimer > 1,000ng/mL; C reactive protein > 5mg/dL, ferritin > 300mg/dL, and lactate dehydrogenase > upper limit of normal. The primary objective will be to compare the clinical status on day 15, as measured by a 7-point ordinal scale applied in COVID-19 trials worldwide. The primary endpoint will be assessed by an ordinal logistic regression assuming proportional odds ratios adjusted for stratification variables (age and sex).
ETHICS AND DISSEMINATION


The TOCIBRAS protocol was approved by local and central (national) ethical committees in Brazil following current national and international guidelines/directives. Each participating center had the study protocol approved by their institutional review boards before initiating protocol enrolment. The data derived from this trial will be published regardless of the results. If proven active, this strategy could alleviate the consequences of the inflammatory response in COVID-19 patients and improve their clinical outcomes.",2020,"We designed a trial testing tocilizumab versus standard of care intending to improve the outcomes by inhibiting interleukin-6, an important inflammatory mediator in COVID-19.
","['patients with moderate to severe COVID-19', 'patients with COVID-19', 'Each participating center had the study protocol approved by their institutional review boards before initiating protocol enrolment']","['tocilizumab', 'tocilizumab plus standard of care versus standard of care alone', 'Tocilizumab']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",[],,0.229721,"We designed a trial testing tocilizumab versus standard of care intending to improve the outcomes by inhibiting interleukin-6, an important inflammatory mediator in COVID-19.
","[{'ForeName': 'Danielle Leão Cordeiro de', 'Initials': 'DLC', 'LastName': 'Farias', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Prats', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'Alexandre Biasi', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Regis Goulart', 'Initials': 'RG', 'LastName': 'Rosa', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Flávia Ribeiro', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Otávio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Organização de Pesquisa Acadêmica, Hospital Israelita Albert Einstein - São Paulo (SP), Brasil.'}, {'ForeName': 'Luciano César Pontes de', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Renato Delascio', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, Estados Unidos.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Avezum', 'Affiliation': 'Centro Internacional de Pesquisa, Hospital Alemão Oswaldo Cruz - São Paulo (SP), Brasil.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Kawano-Dourado', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Lucas Petri', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Salomón Soriano Ordinola', 'Initials': 'SSO', 'LastName': 'Rojas', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'Cleyton Zanardo de', 'Initials': 'CZ', 'LastName': 'Oliveira', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'Luis Eduardo Coelho', 'Initials': 'LEC', 'LastName': 'Andrade', 'Affiliation': 'Fleury Medicina e Laboratórios - São Paulo (SP), Brasil.'}, {'ForeName': 'Alex Freire', 'Initials': 'AF', 'LastName': 'Sandes', 'Affiliation': 'Fleury Medicina e Laboratórios - São Paulo (SP), Brasil.'}, {'ForeName': 'Maria Carolina', 'Initials': 'MC', 'LastName': 'Pintão', 'Affiliation': 'Fleury Medicina e Laboratórios - São Paulo (SP), Brasil.'}, {'ForeName': 'Claudio Galvão de', 'Initials': 'CG', 'LastName': 'Castro Júnior', 'Affiliation': 'Organização de Pesquisa Acadêmica, Hospital Israelita Albert Einstein - São Paulo (SP), Brasil.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Scheinberg', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'Viviane Cordeiro', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}]",Revista Brasileira de terapia intensiva,['10.5935/0103-507X.20200060']
1786,32965797,Short-term water deprivation attenuates the exercise pressor reflex in older female adults.,"Older adults have reduced fluid intake and impaired body fluid and electrolyte regulation. Older female adults exhibit exaggerated exercise blood pressure (BP) responses, which is associated with an increased risk of adverse cardiovascular events. However, it is unclear if dysregulated body fluid homeostasis contributes to altered exercise BP responses in older female adults. We tested the hypothesis that short-term water deprivation (WD) increases exercise BP responses in older female adults. Fifteen female adults (eight young [25 ± 6 years] and seven older [65 ± 6 years]) completed two experimental conditions in random crossover fashion; a euhydration control condition and a stepwise reduction in water intake over three days concluding with a 16-hr WD period. During both trials, beat-to-beat BP (photoplethysmography) and heart rate (electrocardiogram) were continuously assessed during rest, handgrip exercise (30% MVC), and post-exercise ischemia (metaboreflex isolation). At screening, older compared to young female adults had greater systolic and diastolic BP (p ≤ .02). Accelerometer-assessed habitual physical activity was not different between groups (p = .65). Following WD, 24-hr urine flow rate decreased, whereas thirst, urine specific gravity, and plasma osmolality increased (condition: p < .05 for all), but these WD-induced changes were not different between age groups (interaction: p ≥ .31 for all). Resting systolic and diastolic BP values were higher in older compared to young adults (p < .01 for both), but were not different between experimental conditions (p ≥ .20). In contrast to our hypothesis, WD was associated with attenuated systolic BP responses during handgrip exercise (post hoc: p < .01) and post-exercise ischemia (post hoc: p = .03) in older, but not young, female adults. These data suggest that reduced water intake-induced challenges to body fluid homeostasis do not contribute to exaggerated exercise BP responses in post-menopausal female adults.",2020,"Resting systolic and diastolic BP values were higher in older compared to young adults (p < .01 for both), but were not different between experimental conditions (p ≥ .20).","['Older adults', 'older female adults', 'post-menopausal female adults', 'Older female adults', 'Fifteen female adults (eight young [25\xa0±\xa06\xa0years] and seven older [65\xa0±']","['short-term water deprivation (WD', 'Short-term water deprivation']","['systolic and diastolic BP', 'exercise pressor reflex', 'post-exercise ischemia', '24-hr urine flow rate', 'systolic BP responses', 'exercise blood pressure (BP) responses', 'urine specific gravity, and plasma osmolality', 'Resting systolic and diastolic BP values', 'exercise BP responses', 'Accelerometer-assessed habitual physical activity', 'beat-to-beat BP (photoplethysmography) and heart rate (electrocardiogram']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0043048', 'cui_str': 'Water Deprivation'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0232851', 'cui_str': 'Flow of urine'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0202517', 'cui_str': 'Urinalysis, specific gravity measurement'}, {'cui': 'C0860721', 'cui_str': 'Plasma osmolality'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",15.0,0.057706,"Resting systolic and diastolic BP values were higher in older compared to young adults (p < .01 for both), but were not different between experimental conditions (p ≥ .20).","[{'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Austin T', 'Initials': 'AT', 'LastName': 'Robinson', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Babcock', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Kamila U', 'Initials': 'KU', 'LastName': 'Migdal', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Melissa A H', 'Initials': 'MAH', 'LastName': 'Witman', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Wenner', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Stocker', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}]",Physiological reports,['10.14814/phy2.14581']
1787,32960886,Effects of telephone-based health coaching on patient-reported outcomes and health behavior change: A randomized controlled trial.,"OBJECTIVE


Telephone based health coaching (TBHC) seems to be a promising approach to foster self-management in patients with chronic conditions. The aim of this study was to evaluate the effectiveness of a TBHC on patient-reported outcomes and health behavior for people living with chronic conditions in Germany.
METHODS


Patients insured at a statutory health insurance were randomized to an intervention group (IG; TBHC) and a control group (CG; usual care), using a stratified random allocation before giving informed consent (Zelen's single-consent design). The TBHC was based on motivational interviewing, goal setting, and shared decision-making and carried out by trained nurses. All outcomes were assessed yearly for three years. We used mixed effects models utilizing all available data in a modified intention-to-treat sample for the main analysis. Participants and study centers were included as random effects. All models were adjusted for age, education and campaign affiliation.
RESULTS


Of the 10,815 invited patients, 4,283 returned their questionnaires at baseline. The mean age was 67.23 years (SD = 9.3); 55.5% were female. According to the model, TBHC was statistically significant superior to CG regarding 6 of 19 outcomes: physical activity in hours per week (p = .030) and in metabolic rate per week (p = .048), BMI (p = .009) (although mainly at baseline), measuring blood pressure (p< .001), patient activation (p< .001), and health literacy (p< .001). Regarding stages of change (p = .005), the IG group also showed statistically different results than the CG group, however the conclusion remains inconclusive. Within-group contrasts indicating changes from baseline to follow-ups and significant between-group comparisons regarding these changes supported the findings. Standardized effect sizes were small. TBHC did not show any effect on mental QoL, health status, alcohol, smoking, adherence, measuring blood sugar, foot monitoring, anxiety, depression and distress. Campaign-specific subgroup effects were detected for 'foot monitoring by a physician' and 'blood sugar measurement'.
CONCLUSION


TBHC interventions might have small effects on some patient reported and behavioral outcomes.
PRACTICE IMPLICATIONS


Future research should focus on analyzing which intervention components are effective and who profits most from TBHC interventions.
REGISTRATION


German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS): DRKS00000584.",2020,"Regarding stages of change (p = .005), the IG group also showed statistically different results than the CG group, however the conclusion remains inconclusive.","['people living with chronic conditions in Germany', '10,815 invited patients', 'The mean age was 67.23 years (SD = 9.3); 55.5% were female', 'Patients insured at a statutory health insurance', 'patients with chronic conditions']","['TBHC', 'Telephone based health coaching (TBHC', 'control group (CG; usual care', 'intervention group (IG; TBHC', 'telephone-based health coaching']","['BMI', 'mental QoL, health status, alcohol, smoking, adherence, measuring blood sugar, foot monitoring, anxiety, depression and distress', 'metabolic rate', 'blood pressure', 'physical activity', 'health behavior change', 'health literacy', 'patient activation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}]",10815.0,0.0789462,"Regarding stages of change (p = .005), the IG group also showed statistically different results than the CG group, however the conclusion remains inconclusive.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dwinger', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Rezvani', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Levente', 'Initials': 'L', 'LastName': 'Kriston', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Herbarth', 'Affiliation': 'Kaufmännische Krankenkasse, Statutory Health Insurance, Hannover, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Dirmaier', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",PloS one,['10.1371/journal.pone.0236861']
1788,32961507,The effects of acute work stress and appraisal on psychobiological stress responses in a group office environment.,"BACKGROUND


The high prevalence of office stress and its detrimental health consequences are of concern to individuals, employers and society at large. Laboratory studies investigating office stress have mostly relied on data from participants that were tested individually on abstract tasks. In this study, we examined the effect of psychosocial office stress and work interruptions on the psychobiological stress response in a realistic but controlled group office environment. We also explored the role of cognitive stress appraisal as an underlying mechanism mediating the relationship between work stressors and the stress response.
METHODS AND MATERIALS


Ninety participants (44 female; mean age 23.11 ± 3.80) were randomly assigned to either a control condition or one of two experimental conditions in which they were exposed to psychosocial stress with or without prior work interruptions in a realistic multi-participant laboratory setting. To induce psychosocial stress, we adapted the Trier Social Stress Test for Groups to an office environment. Throughout the experiment, we continuously monitored heart rate and heart rate variability. Participants repeatedly reported on their current mood, calmness, wakefulness and perceived stress and gave saliva samples to assess changes in salivary cortisol and salivary alpha-amylase. Additionally, cognitive appraisal of the psychosocial stress test was evaluated.
RESULTS


Our analyses revealed significant group differences for most outcomes during or immediately after the stress test (i.e., mood, calmness, perceived stress, salivary cortisol, heart rate, heart rate variability) and during recovery (i.e., salivary cortisol and heart rate). Interestingly, the condition that experienced work interruptions showed a higher increase of cortisol levels but appraised the stress test as less threatening than individuals that experienced only psychosocial stress. Exploratory mediation analyses revealed a blunted response in subjective measures of stress, which was partially explained by the differences in threat appraisal.
DISCUSSION


The results showed that experimentally induced work stress led to significant responses of subjective measures of stress, the hypothalamic-pituitary-adrenal axis and the autonomic nervous system. However, there appears to be a discrepancy between the psychological and biological responses to preceding work interruptions. Appraising psychosocial stress as less threatening but still as challenging could be an adaptive way of coping and reflect a state of engagement and eustress.",2020,"Exploratory mediation analyses revealed a blunted response in subjective measures of stress, which was partially explained by the differences in threat appraisal.
",['Ninety participants (44 female; mean age 23.11 ± 3.80'],['control condition or one of two experimental conditions in which they were exposed to psychosocial stress with or without prior work interruptions in a realistic multi-participant laboratory setting'],"['heart rate and heart rate variability', 'stress test (i.e., mood, calmness, perceived stress, salivary cortisol, heart rate, heart rate variability) and during recovery (i.e., salivary cortisol and heart rate', 'psychobiological stress responses', 'psychobiological stress response', 'subjective measures of stress, the hypothalamic-pituitary-adrenal axis and the autonomic nervous system', 'cortisol levels', 'current mood, calmness, wakefulness and perceived stress and gave saliva samples', 'salivary cortisol and salivary alpha-amylase']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}]",90.0,0.0154888,"Exploratory mediation analyses revealed a blunted response in subjective measures of stress, which was partially explained by the differences in threat appraisal.
","[{'ForeName': 'Jasmine I', 'Initials': 'JI', 'LastName': 'Kerr', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Cognitive Science, Department of Humanities, Social and Political Sciences, ETH Zurich, Clausiusstrasse 59, 8092 Zurich, Switzerland. Electronic address: jkerr@ethz.ch.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Naegelin', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Raphael P', 'Initials': 'RP', 'LastName': 'Weibel', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ferrario', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'La Marca', 'Affiliation': 'Chair of Clinical Psychology and Psychotherapy, Department of Psychology, University of Zurich, Binzmuehlestrasse 14, 8050 Zurich, Switzerland; Clinica Holistica Engiadina, Plaz 40, 7542 Susch, Switzerland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'von Wangenheim', 'Affiliation': 'Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Hoelscher', 'Affiliation': 'Chair of Cognitive Science, Department of Humanities, Social and Political Sciences, ETH Zurich, Clausiusstrasse 59, 8092 Zurich, Switzerland.'}, {'ForeName': 'Victor R', 'Initials': 'VR', 'LastName': 'Schinazi', 'Affiliation': 'Chair of Cognitive Science, Department of Humanities, Social and Political Sciences, ETH Zurich, Clausiusstrasse 59, 8092 Zurich, Switzerland; Department of Psychology, Bond University, 14 University Drive, Robina Queensland 4226, Australia.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104837']
1789,32961514,The Effect of Intradermal Botulinum Toxin a injections on painful diabetic polyneuropathy.,"BACKGROUND AND AIMS


Botulinum toxin type A (BTX-A) have been recently administered to improve Diabetic neuropathies; however, the efficacy of this treatment for relieving pain in painful diabetic polyneuropathy (DPN) has not been studied yet. Herein, we investigated the efficacy of botulinum toxin A (BTX-A) on DPN.
METHODS


This prospective, randomized, double-blind, controlled trial was performed in Imam Hossein Medical Center, pain clinic (Tehran, Iran). Diabetic patients (141 cases), between 40 and 70 years old with polyneuropathy in lower limbs were randomly assigned to one of these three groups: 1. Group D1 received 150 units of BTX-A in one foot and normal saline 0.9% in the other foot, 2. Group D2 received BTX-A 150 units in both feet, 3. Group N received normal saline 0.9% in both feet. All injections were performed intradermally using insulin syringes in 20 different points of foot. Visual analogue scale (VAS) and neuropathy pain scale (NPS) were used to compare the groups.
RESULTS


The improvement of VAS, pain intensity, sharp and hot sensation, sensitive and unpleasant sensation, deep and surface sensation was significant when comparing BTX-A and placebo groups. However, dull and cold sensations improvement (p = 0.114, and p = 0.653; respectively) did not show a significant difference between BTX-A injection and placebo groups. Furthermore, the percentage of changes after treatment indicated that sharp pain was improved more than other complaints (80%, 81%, and 37% for D1, D2, and N groups; respectively).
CONCLUSION


Intradermal administration of BTX-A was effective in improving VAS and all of the items of NPS in patients with diabetic polyneuropathy, except for dull and cold sensation.",2020,"However, dull and cold sensations improvement (p = 0.114, and p = 0.653; respectively) did not show a significant difference between BTX-A injection and placebo groups.","['painful diabetic polyneuropathy', 'patients with diabetic polyneuropathy', 'Imam Hossein Medical Center, pain clinic (Tehran, Iran', 'painful diabetic polyneuropathy (DPN', 'Diabetic patients (141 cases), between 40 and 70 years old with polyneuropathy in lower limbs']","['Intradermal Botulinum Toxin a injections', 'BTX-A in one foot and normal saline', 'botulinum toxin A (BTX-A', 'BTX', 'placebo', 'normal saline', 'BTX-A']","['dull and cold sensations improvement', 'sharp pain', 'VAS, pain intensity, sharp and hot sensation, sensitive and unpleasant sensation, deep and surface sensation', 'Visual analogue scale (VAS) and neuropathy pain scale (NPS']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0271680', 'cui_str': 'Diabetic polyneuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0242936', 'cui_str': 'Pain clinic'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0278144', 'cui_str': 'Dull pain'}, {'cui': 'C0234192', 'cui_str': 'Cold'}, {'cui': 'C0455270', 'cui_str': 'Sharp pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}]",,0.20487,"However, dull and cold sensations improvement (p = 0.114, and p = 0.653; respectively) did not show a significant difference between BTX-A injection and placebo groups.","[{'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Taheri', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Meghdad', 'Initials': 'M', 'LastName': 'Sedaghat', 'Affiliation': 'Department of Internal Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Solhpour', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Rostami', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Safarpour Lima', 'Affiliation': 'Department of Neurology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: b.safarpour@sbmu.ac.ir.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.09.019']
1790,32964565,Chronic immunoglobulin maintenance therapy in myasthenia gravis.,"BACKGROUND AND PURPOSE


Long-term treatment of myasthenia gravis (MG) includes symptomatic and course-modifying therapies that target the immune system. Recently, both intravenous immunoglobulin (IVIG) and subcutaneous immunoglobulin (SCIG) have emerged as viable options for chronic therapy, considering the favourable safety-efficacy profile and possible immunosuppressant sparing properties. The aim was to investigate the outcomes of the long-term care of generalized MG with immunoglobulin (Ig).
METHODS


This is a retrospective, repeated-measures design study. Charts of generalized MG patients, treated with IVIG/SCIG for at least 6 months, from January 2015 to January 2020, were analysed. The primary outcome was the mean change in Myasthenia Gravis Impairment Index (MGII) after treatment with Ig, comparing baseline to IVIG and SCIG treatment periods. Secondary outcomes included the changes in pyridostigmine, immunosuppressive medications and patient-reported outcome 'percentage of normal' (0%-100%).
RESULTS


Thirty-four patients were treated with chronic Ig therapy (30 IVIG/SCIG, three SCIG, one IVIG). The mean durations of IVIG and SCIG periods were 21.8 ± 19.4 (range 3-64) months and 19.5 ± 11.3 (range 5-45) months respectively. There was a significant reduction in MGII scores (27.7 ± 15.7 baseline; 22.0 ± 17.4 IVIG period; 19.5 ± 18.1 SCIG period; F = 17.9; d.f. = 1.7; P < 0.01), pyridostigmine and immunosuppressant use (P = 0.00). The outcome 'percentage of normal' had a significant positive association with both treatments (P = 0.00).
CONCLUSION


Our study results suggest that patients can be successfully transitioned to IVIG and from IVIG to SCIG in the chronic treatment of generalized MG with reductions in impairments and use of other medications and improvement in overall status with Ig therapy. Prospective, randomized studies are needed to clarify costs and comparative effectiveness.",2020,"There was a significant reduction in MGII scores (27.7±15.7 baseline; 22.0±17.4 IVIG period;19.5±18.1 SCIG period;F=17.9; df =1.7;p<0.01), pyridostigmine and immunosuppressant use (p=0.00).","['Thirty-four patients were treated with chronic Ig therapy (30 IVIG/SCIG, 3 SCIG, 1 IVIG', 'for at least 6 months, from January 2015 to January 2020', 'myasthenia gravis']","['Chronic immunoglobulin maintenance therapy', 'generalized MG with immunoglobulins (Ig', 'pyridostigmine', 'IVIG and subcutaneous immunoglobulin (SCIG', 'IVIG/SCIG']","['changes in pyridostigmine, immunosuppressive medications and patient-reported outcome ""percentage of normal', 'Mean duration of IVIG and SCIG periods', 'MGII scores', 'mean change in Myasthenia Gravis Impairment Index (MGII']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0021022', 'cui_str': 'Immunoglobulin therapy'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0472367', 'cui_str': 'Generalized myasthenia'}, {'cui': 'C0034261', 'cui_str': 'Pyridostigmine'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034261', 'cui_str': 'Pyridostigmine'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",34.0,0.0723462,"There was a significant reduction in MGII scores (27.7±15.7 baseline; 22.0±17.4 IVIG period;19.5±18.1 SCIG period;F=17.9; df =1.7;p<0.01), pyridostigmine and immunosuppressant use (p=0.00).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Alcantara', 'Affiliation': 'Ellen and Martin Prosserman Centre for Neuromuscular Diseases, Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sarpong', 'Affiliation': 'Ellen and Martin Prosserman Centre for Neuromuscular Diseases, Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Barnett', 'Affiliation': 'Ellen and Martin Prosserman Centre for Neuromuscular Diseases, Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Katzberg', 'Affiliation': 'Ellen and Martin Prosserman Centre for Neuromuscular Diseases, Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bril', 'Affiliation': 'Ellen and Martin Prosserman Centre for Neuromuscular Diseases, Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.'}]",European journal of neurology,['10.1111/ene.14547']
1791,32969580,D-Dimer Enhances Risk-Targeted Thromboprophylaxis in Ambulatory Patients with Cancer.,"BACKGROUND


Thromboprophylaxis for ambulatory patients with cancer is effective, although uncertainties remain on who should be targeted. Using D-dimer values from individuals enrolled to the AVERT trial, we sought to identify and validate a more efficient venous thromboembolism (VTE) risk threshold for thromboprophylaxis.
MATERIALS AND METHODS


The AVERT trial compared thromboprophylaxis with apixaban with placebo among patients with cancer with a Khorana Risk Score ≥2. The D-dimer measured at randomization was used to calculate an individualized 6-month VTE risk using the validated CATScore. A modified intention-to-treat analysis was used to assess efficacy (VTE) and safety (major and overall bleeding) in the (a) complete cohort and (b) ≥8% and < 8% 6-month VTE risk thresholds.
RESULTS


Five hundred seventy-four patients were randomized in the AVERT trial; 466 (81%) with baseline D-dimer were included in the study. Two hundred thirty-seven subjects received apixaban; 229 received placebo. In the complete cohort, there were 13 (5.5%) VTE events in the apixaban arm compared with 26 (11.4%) events in the placebo arm (adjusted hazard ratio [aHR] 0.49 [0.25-0.95], p < .05). Number needed to treat (NNT) to prevent one VTE = 17. Eighty-two (35%) and 72 (31%) patients in the apixaban and placebo arms, respectively, had a 6-month VTE risk ≥8%. In this subgroup, 7 (8.4%) VTE events occurred with apixaban and 19 (26.3%) events with placebo (aHR 0.33 [0.14-0.81], p < .05), NNT = 6. Individuals with a VTE risk <8% derived no benefit from apixaban thromboprophylaxis (aHR 0.89 [0.30-2.65), p = .84). Increased rates of overall bleeding were observed with apixaban in both the complete (aHR 2.11 [1.09-4.09], p < .05) and ≥ 8% predicted risk cohorts (aHR 2.87 [0.91-9.13], p = .07).
CONCLUSION


A 6-month VTE risk threshold of ≥8% increases the efficiency of risk-targeted thromboprophylaxis in ambulatory patients with cancer.
IMPLICATIONS FOR PRACTICE


Ambulatory patients with cancer receiving chemotherapy have an increased risk of venous thromboembolism (VTE). A Khorana Risk Score (KRS) ≥2 is currently the suggested threshold for thromboprophylaxis. Using baseline D-dimer values from individuals enrolled to the AVERT trial, this retrospective validation study identifies a 6-month VTE risk of ≥8% as a more efficient threshold for thromboprophylaxis. At this threshold, the number needed to treat to prevent one VTE is 6, compared with 17 when using a KRS ≥2. Conversely, individuals with a predicted risk of <8% derive no clinical benefit from thromboprophylaxis. Future prospective studies should validate this threshold for outpatient thromboprophylaxis.",2020,"Individuals with a VTE risk <8% derived no benefit from apixaban thromboprophylaxis (aHR-0·89 (0·30-2·65), p=0·84).","['237 subjects received', 'cancer patients with a Khorana Risk Score ≥\u20092', 'ambulatory cancer patients', '574 patients were randomized in the AVERT trial, 466 (81%) with baseline D-dimer were included in the study', 'Individuals with a VTE risk <8% derived no benefit from apixaban thromboprophylaxis (aHR-0·89 (0·30-2·65), p=0·84', 'Ambulatory cancer patients receiving']","['D-dimer enhances risk targeted thromboprophylaxis', 'apixaban to placebo', 'apixaban and placebo', 'placebo', 'placebo (aHR-0·33', 'apixaban', 'chemotherapy']","['efficacy (VTE) and safety (major and overall bleeding', 'efficiency of risk targeted thromboprophylaxis', 'risk of venous thromboembolism (VTE', 'rates of overall bleeding', 'VTE events']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C1312385', 'cui_str': 'AHR protein, human'}]","[{'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1312385', 'cui_str': 'AHR protein, human'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",574.0,0.100616,"Individuals with a VTE risk <8% derived no benefit from apixaban thromboprophylaxis (aHR-0·89 (0·30-2·65), p=0·84).","[{'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Division of Hematology and Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Shaw', 'Affiliation': 'Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Nigel S', 'Initials': 'NS', 'LastName': 'Key', 'Affiliation': 'Division of Hematology and Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Ilich', 'Affiliation': 'Division of Hematology and Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Wells', 'Affiliation': 'Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': 'Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, Canada.'}]",The oncologist,['10.1002/onco.13540']
1792,32966290,"Efficacy and safety of praziquantel and dihydroartemisinin piperaquine combination for treatment and control of intestinal schistosomiasis: A randomized, non-inferiority clinical trial.","BACKGROUND


Despite the reported success in reducing morbidity, praziquantel alone is insufficient for the control and elimination of schistosomiasis, partly due to its poor efficacy against the juvenile worms. Artemisinin derivatives are effective against juvenile worms but are less effective against adult worms. We compared the safety and efficacy of praziquantel and Dihydroartemisinin-piperaquine combination against the standard praziquantel alone for treatment of intestinal schistosomiasis.
METHODS


In this randomized, open-label, non-inferiority trial, 639 Schistosoma mansoni infected children were enrolled and randomized to receive either praziquantel alone or praziquantel plus Dihydroartemisinin-piperaquine combination. Two stool samples were collected on consecutive days at baseline, 3 and 8 weeks post-treatment and analyzed using thick smear Kato Katz method. Efficacy was assessed by cure and egg reduction rates at 3 and 8 weeks post-treatment. Adverse events were assessed within four hours of drugs intake. The primary outcome was cure rates at 8 weeks of post-treatment. Secondary outcomes were egg reduction rates at 8 weeks of post-treatment and treatment-associated adverse events.
RESULTS


At 3 weeks of post-treatment, cure rates were 88.3% (263/298, 95% CI = 84.1%- 91.4%) and 81.2% (277/341, 95% CI = 76.7%- 85.0%) for the combination therapy and praziquantel alone, respectively (p < 0.01, odds ratio (OR) = 1.74, 95% CI of OR = 1.11 to 2.69). At 8 weeks, there was a significant drop in the cure rates in praziquantel alone group to 63.9% (218/341, 95% CI = 58.7%- 68.8%) compared to 81.9% (244/298, 95% CI = 77.1%- 85.8%) in the combination therapy group (p < 0.0001, OR = 2.55, 95%CI of OR = 1.75 to 3.69). Egg reduction rates at 8 weeks post-treatment were significantly higher in the combination therapy group 93.6% (95% CI = 90.8%- 96.4%) compared to 87.9% (95% CI = 84.4%- 91.4%) in the praziquantel only group (p = 0.01). On both Univariate and Multivariate regression analysis, type of treatment received was a significant predictor of cure at week 8 post-treatment. Overall, 30.8% (95% CI = 27.2%- 34.4%) of the study participants experienced mild and transient treatment-associated adverse events, post-treatment abdominal pain (27.1%) being the most common adverse event observed. There was no significant difference in the overall occurrence of adverse events between the two treatment groups.
CONCLUSION


Praziquantel and Dihydroartemisinin piperaquine combination therapy is safe, and more efficacious compared to praziquantel alone for the treatment of intestinal schistosomiasis. Further studies are needed to explore if the combination therapy can be considered as an option for mass drug administration to control and eventually eliminate schistosomiasis.",2020,Egg reduction rates at 8 weeks post-treatment were significantly higher in the combination therapy group 93.6% (95% CI = 90.8%- 96.4%) compared to 87.9% (95% CI = 84.4%- 91.4%) in the praziquantel only group (p = 0.01).,"['639 Schistosoma mansoni infected children', 'intestinal schistosomiasis']","['praziquantel and dihydroartemisinin piperaquine combination', 'praziquantel alone or praziquantel plus Dihydroartemisinin-piperaquine combination', 'Praziquantel and Dihydroartemisinin piperaquine combination therapy', 'praziquantel and Dihydroartemisinin-piperaquine combination']","['mild and transient treatment-associated adverse events, post-treatment abdominal pain', 'Egg reduction rates', 'egg reduction rates at 8 weeks of post-treatment and treatment-associated adverse events', 'overall occurrence of adverse events', 'Adverse events', 'safety and efficacy', 'Efficacy and safety', 'Efficacy', 'cure rates', 'cure and egg reduction rates']","[{'cui': 'C0036319', 'cui_str': 'Schistosoma mansoni'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0242497', 'cui_str': 'Intestinal schistosomiasis'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",639.0,0.259822,Egg reduction rates at 8 weeks post-treatment were significantly higher in the combination therapy group 93.6% (95% CI = 90.8%- 96.4%) compared to 87.9% (95% CI = 84.4%- 91.4%) in the praziquantel only group (p = 0.01).,"[{'ForeName': 'Rajabu Hussein', 'Initials': 'RH', 'LastName': 'Mnkugwe', 'Affiliation': 'Department of Clinical Pharmacology, School of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Omary', 'Initials': 'O', 'LastName': 'Minzi', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Safari', 'Initials': 'S', 'LastName': ""Kinung'hi"", 'Affiliation': 'National Institute for Medical Research (NIMR), Mwanza Research Centre, Mwanza, Tanzania.'}, {'ForeName': 'Appolinary', 'Initials': 'A', 'LastName': 'Kamuhabwa', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Aklillu', 'Affiliation': 'Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska University Hospital-Huddinge, Karolinska Institutet, Stockholm, Sweden.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008619']
1793,32966293,Novel dual HIV maintenance therapy with nevirapine plus lamivudine retain viral suppression through 144 weeks-A proof-of-concept study.,"OBJECTIVES


The aim of this proof-of-concept study is to test feasibility and efficacy of NVP plus Lamivudine (3TC) as novel simplified HIV maintenance dual therapy (DT) strategy.
METHODS


Patients under combined antiretroviral treatment (cART) with fully suppressed HIV plasma viral load (pVL) >24 months-whereof >6 months on an NVP- containing regimen-were switched to oral NVP plus 3TC for 24 weeks. Patients could then decide whether to continue DT or return to the previous cART. HIV pVL was monitored monthly until week 144. The primary outcome was confirmed viral failure (RNA >100 copies/ml). Low-level detection of HIV-RNA in plasma was compared in each patient with pre-study viral load measurements.
RESULTS


Twenty patients were included, switched to DT and all completed week 24. One patient decided thereafter to discontinue study participation for personal reasons. After a total of 144 observation weeks, none of the patients failed. The frequency of low- level HIV-RNA detection was not different from the period before randomization.
CONCLUSIONS


Our findings are surprising but given the nature of a proof-of-concept study, the results do not support the use of this dual regimen. However, as this dual HIV maintenance strategy was feasible and effective, over a period of 144 weeks, we suggest NVP plus 3TC warrants further evaluation as potential maintenance option in patients tolerating nevirapine. A properly sized multicentre non-inferiority trial is ongoing to further evaluate the value of this DT maintenance strategy.",2020,"The frequency of low- level HIV-RNA detection was not different from the period before randomization.
","['Patients under combined antiretroviral treatment (cART) with fully suppressed HIV plasma viral load ', 'patients tolerating nevirapine', 'Twenty patients were included, switched to DT and all completed week 24']","['NVP plus Lamivudine (3TC', 'oral NVP plus 3TC', 'nevirapine plus lamivudine']","['viral failure', 'HIV pVL', 'frequency of low- level HIV-RNA detection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",20.0,0.0637505,"The frequency of low- level HIV-RNA detection was not different from the period before randomization.
","[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Kahlert', 'Affiliation': 'Infectious Diseases and Hospital Epidemiology, Cantonal Hospital Sankt Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cipriani', 'Affiliation': 'Infectious Diseases and Hospital Epidemiology, Cantonal Hospital Sankt Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vernazza', 'Affiliation': 'Infectious Diseases and Hospital Epidemiology, Cantonal Hospital Sankt Gallen, St. Gallen, Switzerland.'}]",PloS one,['10.1371/journal.pone.0237770']
1794,32966294,"The effects of poloxamer and sodium alginate mixture (Guardix-SG®) on range of motion after axillary lymph node dissection: A single-center, prospective, randomized, double-blind pilot study.","PURPOSE


Restricted shoulder mobility is a major upper extremity dysfunction associated with lower quality of life and disability after breast cancer surgery. We hypothesized that a poloxamer and sodium alginate mixture (Guardix-SG®) applied after axillary lymph node dissection (ALND) would significantly improve shoulder range of motion (ROM) in patients with breast cancer.
METHODS


We conducted a double-blind, randomized, prospective study to evaluate the clinical efficacy and safety of Guardix-SG® for the prevention of upper extremity dysfunction after ALND. The primary outcome measure was shoulder ROM at baseline (T0) and 3 (T1), 6 (T2), and 12 months (T3) after surgery. Secondary outcome measures were the Disabilities of the Arm, Shoulder, and Hand score(DASH), pain associated with movement, which was assessed using a numeric rating scale, and lymphedema assessed using body composition analyzer.
RESULTS


A total of 83 women with breast cancer were randomly assigned to either the Guardix-SG® group or the control group. In the Guardix-SG® group (n = 37), Guardix-SG® was applied to the axillary region after ALND. In the control group (n = 46), ALND was performed without using Guardix-SG®. Comparing ROM for shoulder flexion before surgery (178.2°) and 12 months after surgery (172.3°), that was restored 12 months after surgery in the Guardix-SG® group, and there was no statistically significant difference between that at before surgery and 12 months after surgery (p = 0.182). No adverse effect was observed in either group.
CONCLUSIONS


The results of this study have shown that Guardix-SG® help improve shoulder ROM without causing adverse effects in patients who underwent breast cancer surgery. However, there was no statistically significant difference from the control group. A further large-scale study is needed to obtain a more conclusive conclusion.
TRIAL REGISTRATION


CRISKCT0003386; https://cris.nih.go.kr (20181207).",2020,"Comparing ROM for shoulder flexion before surgery (178.2°) and 12 months after surgery (172.3°), that was restored 12 months after surgery in the Guardix-SG® group, and there was no statistically significant difference between that at before surgery and 12 months after surgery (p = 0.182).","['83 women with breast cancer', 'upper extremity dysfunction after ALND', 'breast cancer surgery', 'patients who underwent breast cancer surgery', 'patients with breast cancer']","['poloxamer and sodium alginate mixture (Guardix-SG®', 'Guardix-SG®']","['Disabilities of the Arm, Shoulder, and Hand score(DASH), pain associated with movement, which was assessed using a numeric rating scale, and lymphedema assessed using body composition analyzer', 'adverse effect', 'shoulder ROM', 'shoulder range of motion (ROM', 'shoulder ROM at baseline (T0) and 3 (T1), 6 (T2']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1698635', 'cui_str': 'Upper extremity dysfunction'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0600615', 'cui_str': 'Poloxamer'}, {'cui': 'C0142791', 'cui_str': 'Sodium alginate'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C3852262', 'cui_str': 'guardix'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",83.0,0.183932,"Comparing ROM for shoulder flexion before surgery (178.2°) and 12 months after surgery (172.3°), that was restored 12 months after surgery in the Guardix-SG® group, and there was no statistically significant difference between that at before surgery and 12 months after surgery (p = 0.182).","[{'ForeName': 'Sae Byul', 'Initials': 'SB', 'LastName': 'Lee', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Sung-Chan', 'Initials': 'SC', 'LastName': 'Gwark', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Cheol Min', 'Initials': 'CM', 'LastName': 'Kang', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Guiyun', 'Initials': 'G', 'LastName': 'Sohn', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Jisun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Il Yong', 'Initials': 'IY', 'LastName': 'Chung', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Jong Won', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Hee Jeong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Beom Seok', 'Initials': 'BS', 'LastName': 'Ko', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Sei-Hyun', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Junghwa', 'Initials': 'J', 'LastName': 'Do', 'Affiliation': 'Department of Rehabilitation Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Jae Yong', 'Initials': 'JY', 'LastName': 'Jeon', 'Affiliation': 'Department of Rehabilitation Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Jinsung', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, Ulsan University Hospital, Ulsan, Korea.'}, {'ForeName': 'Eunhae', 'Initials': 'E', 'LastName': 'Um', 'Affiliation': 'Department of Surgery, Inje University Ilsan Paik Hospital, Goyang-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Tae In', 'Initials': 'TI', 'LastName': 'Yoon', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, Dongnam institute of Radiological and medical science, Busan, Korea.'}, {'ForeName': 'Sung-Ui', 'Initials': 'SU', 'LastName': 'Jung', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, Kosin University Gospel Hospital, Busan, Korea.'}, {'ForeName': 'Minkyu', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Byung Ho', 'Initials': 'BH', 'LastName': 'Son', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0238284']
1795,32967068,Effect of Vitamin D Supplement on Vulvovaginal Atrophy of the Menopause.,"The effects of oral vitamin D supplements on vaginal health in postmenopausal women with vulvovaginal atrophy (VVA) was evaluated. A double-blinded, randomized placebo-controlled trial was conducted for 12 weeks to investigate changes on vaginal maturation index (VMI), vaginal pH, and the visual analog scale (VAS) of VVA symptoms. The vitamin D group received oral ergocalciferol, at 40,000 IU per week, while the placebo group received an identical placebo capsule. Eighty postmenopausal women were enrolled. There were no significant differences in baseline characteristics between both groups. In an intention-to-treat analysis, VMI, vaginal pH, and VAS of VVA symptoms showed no significant differences between both groups at the six and 12 weeks. However, the mean difference of VMI in the vitamin D group between baseline and at six weeks showed significant improvement (5.5 + 16.27,  p  <0.05). Moreover, the mean vaginal pH and VAS of VVA patients in the vitamin D group were significantly improved at both six and 12 weeks compared to baseline. The oral vitamin D supplementation for 12 weeks potentially improves vaginal health outcomes in postmenopausal women with VVA symptoms, demonstrated by the improved mean VMI, vaginal pH, and VAS at six and 12 weeks between baseline, however, no significant differences were observed from the placebo treatment.",2020,"Moreover, the mean vaginal pH and VAS of VVA patients in the vitamin D group were significantly improved at both six and 12 weeks compared to baseline.","['Eighty postmenopausal women were enrolled', 'postmenopausal women with vulvovaginal atrophy (VVA', 'postmenopausal women with VVA symptoms']","['oral ergocalciferol', 'Vitamin D Supplement', 'vitamin D', 'oral vitamin D supplements', 'placebo capsule', 'placebo', 'oral vitamin D supplementation']","['VMI, vaginal pH, and VAS of VVA symptoms', 'vaginal health', 'Vulvovaginal Atrophy of the Menopause', 'mean VMI, vaginal pH, and VAS', 'vaginal health outcomes', 'VMI', 'mean vaginal pH and VAS', 'vaginal maturation index (VMI), vaginal pH, and the visual analog scale (VAS) of VVA symptoms']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0857741', 'cui_str': 'Vulvovaginal atrophy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0014695', 'cui_str': 'Ergocalciferol'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0857741', 'cui_str': 'Vulvovaginal atrophy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",80.0,0.39508,"Moreover, the mean vaginal pH and VAS of VVA patients in the vitamin D group were significantly improved at both six and 12 weeks compared to baseline.","[{'ForeName': 'Thawinee', 'Initials': 'T', 'LastName': 'Kamronrithisorn', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand.'}, {'ForeName': 'Jittima', 'Initials': 'J', 'LastName': 'Manonai', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery Unit, Department of Obstetrics & Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand.'}, {'ForeName': 'Sakda Arj-Ong', 'Initials': 'SA', 'LastName': 'Vallibhakara', 'Affiliation': 'ASEAN Institute for Health Development, Mahidol University, Nakhon Pathom 73170, Thailand.'}, {'ForeName': 'Areepan', 'Initials': 'A', 'LastName': 'Sophonsritsuk', 'Affiliation': 'Reproductive Endocrinology and Infertility Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand.'}, {'ForeName': 'Orawin', 'Initials': 'O', 'LastName': 'Vallibhakara', 'Affiliation': 'Reproductive Endocrinology and Infertility Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand.'}]",Nutrients,['10.3390/nu12092876']
1796,32967132,Vitamin D Correction Down-Regulates Serum Amyloid P Component Levels in Vitamin D Deficient Arab Adults: A Single-Arm Trial.,"Vitamin D (VD) has been observed to have anti-inflammatory properties. However, the effects of VD supplementation on the serum amyloid P component (SAP) has not been established. This study aimed to investigate the effect of VD supplementation on serum SAP levels in Arab adults. A total of 155 VD-deficient adult Saudis (56 males and 99 females) were recruited in this non-randomized, 6-month, single-arm trial. The intervention was as follows; cholecalciferol 50,000 international units (IU) every week for the first 2 months, followed by 50,000 twice a month for the next two months, and for the last two months, 1000 IU daily. Serum 25(OH)D, SAP, C-reactive protein (CRP), lipid profile, and glucose were assessed at baseline and post-intervention. At post-intervention, VD levels were significantly increased, while SAP levels significantly decreased in all study participants. Remarkably, this reduction in SAP was more significant in males than females after stratification. SAP was inversely correlated with VD overall (r = -0.17,  p  < 0.05), and only in males (r = -0.27,  p  < 0.05) after stratification according to sex after 6 months of VD supplementation. Such a relationship was not observed at baseline. VD supplementation can favorably modulate serum SAP concentrations in Arab adults, particularly in males.",2020,"At post-intervention, VD levels were significantly increased, while SAP levels significantly decreased in all study participants.","['A total of 155 VD-deficient adult Saudis (56 males and 99 females', 'Vitamin D Deficient Arab Adults', 'Arab adults, particularly in males', 'Arab adults']","['VD supplementation', 'Vitamin D Correction Down', 'Vitamin D (VD', 'cholecalciferol']","['SAP', 'serum SAP levels', 'VD levels', 'SAP levels', 'serum SAP concentrations', 'Serum 25(OH)D, SAP, C-reactive protein (CRP), lipid profile, and glucose']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0282540', 'cui_str': 'Arabs'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0002721', 'cui_str': 'Amyloid P component'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",,0.0318965,"At post-intervention, VD levels were significantly increased, while SAP levels significantly decreased in all study participants.","[{'ForeName': 'Osama E', 'Initials': 'OE', 'LastName': 'Amer', 'Affiliation': 'Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Malak N K', 'Initials': 'MNK', 'LastName': 'Khattak', 'Affiliation': 'Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Abdullah M', 'Initials': 'AM', 'LastName': 'Alnaami', 'Affiliation': 'Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Naji J', 'Initials': 'NJ', 'LastName': 'Aljohani', 'Affiliation': 'Specialized Diabetes and Endocrine Center, King Fahad Medical City, Riyadh 11525, Saudi Arabia.'}, {'ForeName': 'Nasser M', 'Initials': 'NM', 'LastName': 'Al-Daghri', 'Affiliation': 'Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}]",Nutrients,['10.3390/nu12092880']
1797,32975189,"Imiquimod versus podophyllotoxin, with and without human papillomavirus vaccine, for anogenital warts: the HIPvac factorial RCT.","BACKGROUND


The comparative efficacy, and cost-effectiveness, of imiquimod or podophyllotoxin cream, either alone or in combination with the quadrivalent HPV vaccine (Gardasil ® , Merck Sharp & Dohme Corp., Merck & Co., Inc., Whitehouse Station, NJ, USA) in the treatment and prevention of recurrence of anogenital warts is not known.
OBJECTIVE


The objective was to compare the efficacy of imiquimod and podophyllotoxin creams to treat anogenital warts and to assess whether or not the addition of quadrivalent human papillomavirus vaccine increases wart clearance or prevention of recurrence.
DESIGN


A randomised, controlled, multicentre, partially blinded factorial trial. Participants were randomised equally to four groups, combining either topical treatment with quadrivalent human papillomavirus vaccine or placebo. Randomisation was stratified by gender, a history of previous warts and human immunodeficiency virus status. There was an accompanying economic evaluation, conducted from the provider perspective over the trial duration.
SETTING


The setting was 22 sexual health clinics in England and Wales.
PARTICIPANTS


Participants were patients with a first or repeat episode of anogenital warts who had not been treated in the previous 3 months and had not previously received quadrivalent human papillomavirus vaccine.
INTERVENTIONS


Participants were randomised to 5% imiquimod cream (Aldara ® ; Meda Pharmaceuticals, Takeley, UK) for up to 16 weeks or 0.15% podophyllotoxin cream (Warticon ® ; GlaxoSmithKlein plc, Brentford, UK) for 4 weeks, which was extended to up to 16 weeks if warts persisted. Participants were simultaneously randomised to quadrivalent human papillomavirus vaccine (Gardasil) or saline control at 0, 8 and 24 weeks. Cryotherapy was permitted after week 4 at the discretion of the investigator.
MAIN OUTCOME MEASURES


The main outcome measures were a combined primary outcome of wart clearance at week 16 and remaining wart free at week 48. Efficacy analysis was by logistic regression with multiple imputation for missing follow-up values; economic evaluation considered the costs per quality-adjusted life-year.
RESULTS


A total of 503 participants were enrolled and attended at least one follow-up visit. The mean age was 31 years, 66% of participants were male (24% of males were men who have sex with men), 50% had a previous history of warts and 2% were living with human immunodeficiency virus. For the primary outcome, the adjusted odds ratio for imiquimod cream versus podophyllotoxin cream was 0.81 (95% confidence interval 0.54 to 1.23), and for quadrivalent human papillomavirus vaccine versus placebo, the adjusted odds ratio was 1.46 (95% confidence interval 0.97 to 2.20). For the components of the primary outcome, the adjusted odds ratio for wart free at week 16 for imiquimod versus podophyllotoxin was 0.77 (95% confidence interval 0.52 to 1.14) and for quadrivalent human papillomavirus vaccine versus placebo was 1.30 (95% confidence interval 0.89 to 1.91). The adjusted odds ratio for remaining wart free at 48 weeks (in those who were wart free at week 16) for imiquimod versus podophyllotoxin was 0.98 (95% confidence interval 0.54 to 1.78) and for quadrivalent human papillomavirus vaccine versus placebo was 1.39 (95% confidence interval 0.73 to 2.63). Podophyllotoxin plus quadrivalent human papillomavirus vaccine had inconclusive cost-effectiveness compared with podophyllotoxin alone.
LIMITATIONS


Hepatitis A vaccine as control was replaced by a saline placebo in a non-identical syringe, administered by someone outside the research team, for logistical reasons. Sample size was reduced from 1000 to 500 because of slow recruitment and other delays.
CONCLUSIONS


A benefit of the vaccine was not demonstrated in this trial. The odds of clearance at week 16 and remaining clear at week 48 were 46% higher with vaccine, and consistent effects were seen for both wart clearance and recurrence separately, but these differences were not statistically significant. Imiquimod and podophyllotoxin creams had similar efficacy for wart clearance, but with a wide confidence interval. The trial results do not support earlier evidence of a lower recurrence with use of imiquimod than with use of podophyllotoxin. Podophyllotoxin without quadrivalent human papillomavirus vaccine is the most cost-effective strategy at the current vaccine list price. A further larger trial is needed to definitively investigate the effect of the vaccine; studies of the immune response in vaccine recipients are needed to investigate the mechanism of action.
TRIAL REGISTRATION


Current Controlled Trials. Current Controlled Trials ISRCTN32729817 and EudraCT 2013-002951-14.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 47. See the NIHR Journals Library website for further project information.",2020,"Imiquimod and podophyllotoxin creams had similar efficacy for wart clearance, but with a wide confidence interval.","['The mean age was 31 years, 66% of participants were male (24% of males were men who have sex with men), 50% had a previous history of warts and 2% were living with human immunodeficiency virus', '503 participants were enrolled and attended at least one follow-up visit', 'Participants were patients with a first or repeat episode of anogenital warts who had not been treated in the previous 3 months and had not previously received quadrivalent human papillomavirus vaccine', 'anogenital warts', '22 sexual health clinics in England and Wales']","['saline placebo', 'imiquimod', 'imiquimod or podophyllotoxin cream, either alone or in combination with the quadrivalent HPV vaccine (Gardasil ® , Merck Sharp & Dohme Corp., Merck & Co., Inc., Whitehouse Station, NJ, USA', 'imiquimod and podophyllotoxin creams', 'podophyllotoxin cream', 'topical treatment with quadrivalent human papillomavirus vaccine or placebo', 'podophyllotoxin', 'Podophyllotoxin plus quadrivalent human papillomavirus vaccine', 'vaccine', 'Cryotherapy', 'placebo', 'quadrivalent human papillomavirus vaccine (Gardasil) or saline control', 'imiquimod cream (Aldara ® ; Meda Pharmaceuticals, Takeley, UK) for up to 16 weeks or 0.15% podophyllotoxin cream (Warticon ® ; GlaxoSmithKlein plc, Brentford, UK', 'imiquimod versus podophyllotoxin', 'Imiquimod and podophyllotoxin creams', 'Podophyllotoxin without quadrivalent human papillomavirus vaccine', 'Imiquimod versus podophyllotoxin, with and without human papillomavirus vaccine']","['wart clearance', 'odds of clearance', 'adjusted odds ratio for imiquimod cream', 'adjusted odds ratio for remaining wart free', 'adjusted odds ratio for wart free']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0009663', 'cui_str': 'Genital warts'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1815829', 'cui_str': 'Human papillomavirus type 6, 11, 16, and 18 vaccine'}, {'cui': 'C3839552', 'cui_str': 'Sexual health clinic'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C1721787', 'cui_str': 'Gardasil'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1815829', 'cui_str': 'Human papillomavirus type 6, 11, 16, and 18 vaccine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1252977', 'cui_str': 'imiquimod Topical Cream'}, {'cui': 'C0718327', 'cui_str': 'Aldara'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C0592268', 'cui_str': 'Warticon'}]","[{'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C1252977', 'cui_str': 'imiquimod Topical Cream'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",503.0,0.405304,"Imiquimod and podophyllotoxin creams had similar efficacy for wart clearance, but with a wide confidence interval.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gilson', 'Affiliation': 'University College London Centre for Clinical Research in Infection and Sexual Health, Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Diarmuid', 'Initials': 'D', 'LastName': 'Nugent', 'Affiliation': 'University College London Centre for Clinical Research in Infection and Sexual Health, Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Bennett', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Doré', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Macey L', 'Initials': 'ML', 'LastName': 'Murray', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Meadows', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Haddow', 'Affiliation': 'University College London Centre for Clinical Research in Infection and Sexual Health, Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lacey', 'Affiliation': 'Centre for Immunology and Infection, Hull York Medical School, University of York, York, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Sandmann', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jit', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Soldan', 'Affiliation': 'Statistics, Modelling and Economics Department, Public Health England, London, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Tetlow', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Caverly', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Mayura', 'Initials': 'M', 'LastName': 'Nathan', 'Affiliation': 'Homerton Anogenital Neoplasia Service, Homerton University Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Copas', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24470']
1798,32976702,Simultaneous robotic kidney transplantation and bariatric surgery for morbidly obese patients with end-stage renal failure.,"Patients with obesity have limited access to kidney transplantation, mainly due to an increased incidence of surgical complications, which could be reduced with selective use of robotic-assisted surgery. This prospective randomized controlled trial compares the safety and efficacy of combining robotic sleeve gastrectomy and robotic-assisted kidney transplant to robotic kidney transplant alone in candidates with class II or III obesity. Twenty candidates were recruited, 11 were randomized to the robotic sleeve gastrectomy and robotic-assisted kidney transplant group and 9 to the robotic kidney transplant group. At 12-month follow-up, change in body mass index was -8.76 ± 1.82 in the robotic sleeve gastrectomy and robotic-assisted kidney transplant group compared to 1.70 ± 2.30 in the robotic kidney transplant group (P = .0041). Estimated glomerular filtration rate, serum creatinine, readmission rates, and graft failure rates up to 12 months were not different between the two groups. Length of surgery was longer in the robotic sleeve gastrectomy and robotic-assisted kidney transplant group (405 minutes vs. 269 minutes, p = .00304) without increase in estimated blood loss (120 ml vs. 117 ml, p = .908) or incidence of surgical complications. Combined robotic-assisted kidney transplant and sleeve gastrectomy is safe and effective compared to robotic-assisted kidney transplant alone.",2020,Combined robotic-assisted kidney transplant and sleeve gastrectomy is safe and effective compared to robotic-assisted kidney transplant alone.,"['candidates with class II or III obesity', 'Twenty candidates were recruited, 11 were randomized to the', 'morbidly obese patients with end-stage renal failure', 'Patients with obesity']","['robotic sleeve gastrectomy and robotic-assisted kidney transplant group and 9 to the robotic kidney transplant group', 'robotic sleeve gastrectomy and robotic-assisted kidney transplant', 'robotic sleeve gastrectomy and robotic-assisted kidney transplant to robotic kidney transplant alone', 'Combined robotic-assisted kidney transplant and sleeve gastrectomy', 'Simultaneous robotic kidney transplantation and bariatric surgery']","['body mass index', 'safety and efficacy', 'Length of surgery', 'estimated blood loss', 'Estimated glomerular filtration rate, serum creatinine, readmission rates, and graft failure rates', 'incidence of surgical complications']","[{'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",20.0,0.0243487,Combined robotic-assisted kidney transplant and sleeve gastrectomy is safe and effective compared to robotic-assisted kidney transplant alone.,"[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Spaggiari', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Di Cocco', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Kiara', 'Initials': 'K', 'LastName': 'Tulla', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Kerim B', 'Initials': 'KB', 'LastName': 'Kaylan', 'Affiliation': 'College of Medicine, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Masrur', 'Affiliation': 'Division of General, Minimally Invasive, & Robotic Surgery, Department of Surgery, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Chandra', 'Initials': 'C', 'LastName': 'Hassan', 'Affiliation': 'Division of General, Minimally Invasive, & Robotic Surgery, Department of Surgery, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Alvarez', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Benedetti', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Tzvetanov', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Illinois at Chicago, Chicago, IL.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16322']
1799,32969541,"Internet-based therapy versus face-to-face therapy for alcohol use disorder, a randomized controlled non-inferiority trial.","BACKGROUND AND AIMS


Most people with alcohol use disorder (AUD) are never treated. Internet-based interventions are effective in reducing alcohol consumption and could help to overcome some of the barriers to people not seeking or receiving treatment. The aim of the current study was to compare internet-delivered and face-to-face treatment among adult users with AUD.
DESIGN


Randomized controlled non-inferiority trial with a parallel design, comparing internet-delivered cognitive-behavioural therapy (ICBT) (n = 150) with face-to-face CBT (n = 151), at 3- and 6-month follow-ups.
SETTING


A specialized clinic for people with AUD in Stockholm, Sweden. Participants were recruited between 8 December 2015 and 5 January 2018.
PARTICIPANTS


A total of 301 patients [mean age 50 years, standard deviation (SD) = 12.3] with AUD, of whom 115 (38%) were female and 186 (62%) were male.
INTERVENTION AND COMPARATOR


Participants were randomized in blocks of 20 at a ratio of 1 : 1 to five modules of therapist-guided ICBT or to five modules of face-to-face CBT, delivered over a 3-month period. The same treatment material and the same therapists were used in both groups.
MEASUREMENTS


The primary outcome was standard drinks of alcohol consumed during the previous week at 6-month follow-up, analysed according to intention-to-treat. The pre-specified non-inferiority limit was five standard drinks of alcohol and d = 0.32 for secondary outcomes.
RESULTS


The difference in alcohol consumption between the internet and the face-to-face group was non-inferior in the intention-to-treat analysis of data from the 6-month follow-up [internet = 12.33 and face-to-face = 11.43, difference = 0.89, 95% confidence interval (CI) = -1.10 to 2.88]. The secondary outcome, Alcohol Use Disorder Identification Test score, failed to show non-inferiority of internet compared with face-to-face in the intention-to-treat analysis at 6-month follow-up (internet = 12.26 and face-to-face = 11.57, d = 0.11, 95% CI = -0.11 to 0.34).
CONCLUSIONS


Internet-delivered treatment was non-inferior to face-to-face treatment in reducing alcohol consumption among help-seeking patients with alcohol use disorder but failed to show non-inferiority on some secondary outcomes.",2020,"The difference in alcohol consumption between the internet and the face-to-face group was non-inferior in the intention-to-treat analysis of data from the six-month follow-up (internet=12.33 and face-to-face=11.43,","['Participants were recruited between 8 December, 2015, and 5 January, 2018', 'adult users with AUD', 'people with alcohol use disorder (AUD', 'A specialized clinic for people with AUD in Stockholm, Sweden', '301 patients (mean age 50 years [SD 12.3]) with AUD, of whom 115 (38%) were female and 186 (62%) were male']","['internet-delivered cognitive-behavioural therapy (ICBT) (n=150) with face-to-face CBT', 'therapist-guided ICBT or to five modules of face-to-face CBT', 'Internet-based therapy vs. face-to-face therapy']","['alcohol consumption', 'standard drinks of alcohol', 'Alcohol Use Disorder Identification Test score, failed to show non-inferiority of internet compared with face-to-face in the intention-to-treat analysis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C2732658', 'cui_str': 'Alcohol use disorders identification test score'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]",,0.0935829,"The difference in alcohol consumption between the internet and the face-to-face group was non-inferior in the intention-to-treat analysis of data from the six-month follow-up (internet=12.33 and face-to-face=11.43,","[{'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Johansson', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Sinadinovic', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Gajecki', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Lindner', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Berman', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ulric', 'Initials': 'U', 'LastName': 'Hermansson', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Andréasson', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}]","Addiction (Abingdon, England)",['10.1111/add.15270']
1800,32966587,The effect of mannitol on oxidation-reduction potential in patients undergoing deceased donor renal transplantation-A randomized controlled trial.,"BACKGROUND


Mannitol, an osmotic diuretic, is proposed to be an oxygen radical scavenger. Mannitol is often used in renal transplantation to attenuate oxidative stress and thus to protect renal graft function. We tested the hypothesis that mannitol reduces overall oxidative stress during deceased donor renal transplantation.
METHODS


We randomly assigned 34 patients undergoing deceased donor renal transplantation to receive a solution of mannitol or placebo shortly before graft reperfusion until the end of surgery. We evaluated oxidative stress by measuring the static oxidative-reduction potential (sORP) and the capacity of the oxidative-reduction potential (cORP). sORP and cORP were measured pre-operatively, before and within 10 minutes after graft reperfusion, and post-operatively.
RESULTS


Seventeen patients were enrolled in the mannitol group and 17 patients were enrolled in the placebo group. Mannitol had no significant effect on sORP (148.5 mV [136.2; 160.2]) as compared to placebo (143.6 mV [135.8; 163.2], P = .99). There was also no significant difference in cORP between the mannitol (0.22 µC [0.16; 0.36]) and the placebo group (0.22 µC [0.17; 0.38], P = .76).
CONCLUSION


Mannitol showed no systemic redox scavenging effects during deceased donor renal transplantation. To evaluate the direct effect of mannitol on the renal graft further studies are needed.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02705573.",2020,"There was also no significant difference in cORP between the mannitol (0.22µC [0.16; 0.36]) and the placebo group (0.22 µC [0.17; 0.38], P = 0.76).
","['34 patients undergoing deceased donor renal transplantation to receive a', '17 patients were enrolled in the mannitol group and 17 patients were enrolled in the placebo group', 'patients undergoing deceased donor renal transplantation ', 'deceased donor renal transplantation']","['mannitol', 'placebo', 'solution of mannitol or placebo', 'Mannitol']","['systemic redox scavenging effects', 'sORP and cORP', 'overall oxidative stress', 'cORP', 'sORP', 'static oxidative-reduction potential (sORP) and the capacity of the oxidative-reduction potential (cORP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0730392', 'cui_str': 'Donor renal transplantation'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",34.0,0.381711,"There was also no significant difference in cORP between the mannitol (0.22µC [0.16; 0.36]) and the placebo group (0.22 µC [0.17; 0.38], P = 0.76).
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Reiterer', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Clinical Department of Nephrology and Dialysis, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Sljivic', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Falkner von Sonnenburg', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Fleischmann', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kabon', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13713']
1801,32966830,"Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial.","BACKGROUND


Preferred neoadjuvant regimens for early-stage triple-negative breast cancer (TNBC) include anthracycline-cyclophosphamide and taxane-based chemotherapy. IMpassion031 compared efficacy and safety of atezolizumab versus placebo combined with nab-paclitaxel followed by doxorubicin plus cyclophosphamide as neoadjuvant treatment for early-stage TNBC.
METHODS


This double-blind, randomised, phase 3 study enrolled patients in 75 academic and community sites in 13 countries. Patients aged 18 years or older with previously untreated stage II-III histologically documented TNBC were randomly assigned (1:1) to receive chemotherapy plus intravenous atezolizumab at 840 mg or placebo every 2 weeks. Chemotherapy comprised of nab-paclitaxel at 125 mg/m 2  every week for 12 weeks followed by doxorubicin at 60 mg/m 2  and cyclophosphamide at 600 mg/m 2  every 2 weeks for 8 weeks, which was then followed by surgery. Stratification was by clinical breast cancer stage and programmed cell death ligand 1 (PD-L1) status. Co-primary endpoints were pathological complete response in all-randomised (ie, all randomly assigned patients in the intention-to-treat population) and PD-L1-positive (ie, patients with PD-L1-expressing tumour infiltrating immune cells covering ≥1% of tumour area) populations. This study is registered with ClinicalTrials.gov (NCT03197935), Eudra (CT2016-004734-22), and the Japan Pharmaceutical Information Center (JapicCTI-173630), and is ongoing.
FINDINGS


Between July 7, 2017, and Sept 24, 2019, 455 patients were recruited and assessed for eligibility. Of the 333 eligible patients, 165 were randomly assigned to receive atezolizumab plus chemotherapy and 168 to placebo plus chemotherapy. At data cutoff (April 3, 2020), median follow-up was 20·6 months (IQR 8·7-24·9) in the atezolizumab plus chemotherapy group and 19·8 months (8·1-24·5) in the placebo plus chemotherapy group. Pathological complete response was documented in 95 (58%, 95% CI 50-65) patients in the atezolizumab plus chemotherapy group and 69 (41%, 34-49) patients in the placebo plus chemotherapy group (rate difference 17%, 95% CI 6-27; one-sided p=0·0044 [significance boundary 0·0184]). In the PD-L1-positive population, pathological complete response was documented in 53 (69%, 95% CI 57-79) of 77 patients in the atezolizumab plus chemotherapy group versus 37 (49%, 38-61) of 75 patients in the placebo plus chemotherapy group (rate difference 20%, 95% CI 4-35; one-sided p=0·021 [significance boundary 0·0184]). In the neoadjuvant phase, grade 3-4 adverse events were balanced and treatment-related serious adverse events occurred in 37 (23%) and 26 (16%) patients, with one patient per group experiencing an unrelated grade 5 adverse event (traffic accident in the atezolizumab plus chemotherapy group and pneumonia in the placebo plus chemotherapy group).
INTERPRETATION


In patients with early-stage TNBC, neoadjuvant treatment with atezolizumab in combination with nab-paclitaxel and anthracycline-based chemotherapy significantly improved pathological complete response rates with an acceptable safety profile.
FUNDING


F Hoffmann-La Roche/Genentech.",2020,"Pathological complete response was documented in 95 (58%, 95% CI 50-65) patients in the atezolizumab plus chemotherapy group and 69 (41%, 34-49) patients in the placebo plus chemotherapy group (rate difference 17%, 95% CI 6-27; one-sided p=0·0044 [significance boundary 0·0184]).","['333 eligible patients', 'patients with early-stage triple-negative breast cancer (IMpassion031', 'Patients aged 18 years or older with previously untreated stage II-III', 'early-stage triple-negative breast cancer (TNBC', 'Between July 7, 2017, and Sept 24, 2019, 455 patients were recruited and assessed for eligibility', 'enrolled patients in 75 academic and community sites in 13 countries']","['sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy', 'chemotherapy plus intravenous atezolizumab at 840 mg or placebo', 'Neoadjuvant atezolizumab', 'atezolizumab plus chemotherapy', 'atezolizumab in combination with nab-paclitaxel and anthracycline-based chemotherapy', 'placebo combined with nab-paclitaxel', 'Chemotherapy comprised of nab-paclitaxel', 'placebo plus chemotherapy', 'doxorubicin at 60 mg/m 2  and cyclophosphamide', 'atezolizumab', 'doxorubicin plus cyclophosphamide', 'anthracycline-cyclophosphamide and taxane-based chemotherapy']","['efficacy and safety', 'Pathological complete response', 'pathological complete response', 'pathological complete response rates', 'serious adverse events']","[{'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",455.0,0.693364,"Pathological complete response was documented in 95 (58%, 95% CI 50-65) patients in the atezolizumab plus chemotherapy group and 69 (41%, 34-49) patients in the placebo plus chemotherapy group (rate difference 17%, 95% CI 6-27; one-sided p=0·0044 [significance boundary 0·0184]).","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Mittendorf', 'Affiliation': ""Dana-Farber/Brigham and Women's Cancer Center, Boston, MA, USA. Electronic address: emittendorf@bwh.harvard.edu.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Carlos H', 'Initials': 'CH', 'LastName': 'Barrios', 'Affiliation': 'Centro de Pesquisa em Oncologia, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Shigehira', 'Initials': 'S', 'LastName': 'Saji', 'Affiliation': 'Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hegg', 'Affiliation': 'University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Koehler', 'Affiliation': 'Gemeinschaftspraxis für Haematologie und Onkologie Langen, Langen, Germany.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Yonsei Cancer Center, Yonsei University Health System, Seoul, South Korea.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Telli', 'Affiliation': 'School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Ferrario', 'Affiliation': 'Jewish General Hospital-McGill University, Montréal, QC, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Punie', 'Affiliation': 'Department of General Medical Oncology and Multidisciplinary Breast Centre, Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Penault-Llorca', 'Affiliation': 'Department of Biopathology, Centre Jean Perrin and University Clermont Auvergne/INSERM U1240, Clermont-Ferrand, France.'}, {'ForeName': 'Shilpen', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Anh Nguyen', 'Initials': 'AN', 'LastName': 'Duc', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Liste-Hermoso', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Maiya', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Molinero', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Stephen Y', 'Initials': 'SY', 'LastName': 'Chui', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Breast Center, Department of Gynecology and Obstetrics and Comprehensive Cancer Center of the Ludwig-Maximilians-University, Munich, Germany.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31953-X']
1802,32966877,Real-world exposure to graphic warning labels on cigarette packages in US smokers: The CASA randomized trial protocol.,"BACKGROUND


The US lags behind >120 countries in implementing graphic warning labels (GWLs) on cigarette packs. US courts prevented implementation of FDA's 2012 rule requiring GWLs citing the need for more evidence on effectiveness. After more research, in 2020, the FDA proposed a revised rule mandating GWLs. This trial will test how the introduction of GWLs influence cognitions and behavior in US smokers.
METHOD


To investigate the ""real-world"" impact of GWLs in US smokers, we are conducting a randomized trial involving a 3-month intervention and 8-month follow-up. The study recruited California smokers between September 2016 through December 2019 and randomly assigned them into 3 groups (1) Blank Pack devoid of any cigarette branding; (2) GWL Pack featuring 1 of 3 rotating images added to blank pack; or (3) their usual Standard US Pack. Throughout the 3-month intervention, participants purchased study-packaged cigarettes and reported daily cognitions and behavior through ecological momentary assessments. We will validate self-reported tobacco use with saliva cotinine concentrations following the 3-month intervention and 8-month follow-up.
RESULTS


The trial enrolled 359 participants (average age 39 years; average cigarette consumption half a pack/day). The 3 study groups were balanced on age, gender, race-ethnicity, education and income (17% low income) as well as on smoking related variables.
CONCLUSIONS


This 3-month real-world randomized trial will test the effect of repackaging cigarettes from standard US packs to GWL plain packs on smokers' perceptions of the risks of smoking, their perception of the appeal of their cigarettes, and on their smoking behavior.",2020,"We will validate self-reported tobacco use with saliva cotinine concentrations following the 3-month intervention and 8-month follow-up.
","['US smokers', 'California smokers between September 2016 through December 2019 and randomly assigned them into 3 groups (1', '359 participants (average age 39\u202fyears; average cigarette consumption half a pack/day']","['Blank Pack devoid of any cigarette branding; (2) GWL Pack featuring 1 of 3 rotating images added to blank pack; or (3) their usual Standard US Pack', 'Real-world exposure to graphic warning labels', 'repackaging cigarettes from standard US packs to GWL plain packs']",[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0231458', 'cui_str': 'Rotated'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",[],359.0,0.0172592,"We will validate self-reported tobacco use with saliva cotinine concentrations following the 3-month intervention and 8-month follow-up.
","[{'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Pierce', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: jppierce@ucsd.edu.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Strong', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: dstrong@ucsd.edu.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Stone', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: m3stone@ucsd.edu.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Villaseñor', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: adriana.villasenor@sdcounty.ca.gov.'}, {'ForeName': 'Claudiu V', 'Initials': 'CV', 'LastName': 'Dimofte', 'Affiliation': 'Department of Marketing, San Diego State University, 5500 Campanile Dr, San Diego, CA 92182, United States. Electronic address: cdimofte@sdsu.edu.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Leas', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: ecleas@ucsd.edu.'}, {'ForeName': 'Jesica', 'Initials': 'J', 'LastName': 'Oratowski', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: joratowski@ucsd.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Brighton', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: ebrighton@ucsd.edu.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hurst', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States. Electronic address: shurst@ucsd.edu.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Pulvers', 'Affiliation': 'Department of Psychology, Social and Behavioral Sciences Building, California State University, San Marcos 200 E Barham Dr, San Marcos, CA, 92096, United States. Electronic address: kpulvers@csusm.edu.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Kealey', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States.'}, {'ForeName': 'Ruifeng', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: ruc075@ucsd.edu.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Messer', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Division of Biostatistics, Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: kmesser@ucsd.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106152']
1803,32966919,"Effects of vitamin D supplementation on core symptoms, serum serotonin, and interleukin-6 in children with autism spectrum disorders: A randomized clinical trial.","OBJECTIVES


Children with autism spectrum disorders (ASD) have lower serum vitamin D and higher serotonin and interleukin (IL)-6 levels compared with healthy children. The aim of this study was to evaluate the effect of vitamin D on core symptoms and serum levels of serotonin and IL-6 in these children.
METHODS


This parallel randomized double-blind, placebo-controlled trial was conducted with 43 children with ASD (7 girls and 36 boys; 8.91 ± 2.87 y of age). Children were randomly allocated to receive either vitamin D drop (300 IU/kg up to a maximum of 6000 IU daily) or placebo for 15 wk. Serum levels of 25-hydroxyvitamin (OH)D, IL-6, and serotonin were measured at baseline and at the end of the trial. Also, the severity of autism and the social and individual maturity of the children were measured by the Childhood Autism Rating Scale (CARS), the Autism Treatment Assessment Checklist (ATEC), and Aberrant Behavior Checklist-Community (ABC-C) questionnaires before and after intervention. Randomization and allocation to groups were done using computer-generated numbers.
RESULTS


More than 86% of patients had vitamin D deficiency at the beginning of the study. Serum levels of 25(OH)D increased significantly in the vitamin D group (P = 0.001). The clinical symptoms of autism measured by CARS and ATEC scales were alleviated significantly (P = 0.021 and P = 0.020, respectively); however, the serum levels of serotonin and IL-6 and the scale of ABC-C remained without a significant change.
CONCLUSION


These findings suggest that vitamin D supplementation may improve ASD symptoms; however, more studies with longer duration are indispensable to confirm our results.",2020,Serum levels of 25(OH)D increased significantly in the vitamin D group (P = 0.001).,"['43 children with ASD (7 girls and 36 boys; 8.91 ±', 'children with autism spectrum disorders', 'Children with autism spectrum disorders (ASD']","['vitamin D supplementation', 'placebo', 'vitamin D']","['Childhood Autism Rating Scale (CARS), the Autism Treatment Assessment Checklist (ATEC), and Aberrant Behavior Checklist-Community (ABC-C) questionnaires', 'Serum levels of 25(OH)D', 'ASD symptoms', 'serum levels of serotonin and IL-6 and the scale of ABC-C', 'CARS and ATEC scales', 'core symptoms, serum serotonin, and interleukin-6', 'serum vitamin D and higher serotonin and interleukin (IL)-6 levels', 'vitamin D deficiency', 'Serum levels of 25-hydroxyvitamin (OH)D, IL-6, and serotonin']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C2209695', 'cui_str': 'Serum serotonin'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}]",43.0,0.328924,Serum levels of 25(OH)D increased significantly in the vitamin D group (P = 0.001).,"[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Javadfar', 'Affiliation': 'Student Research Committee, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Abdollahzad', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran; Research Center for Environmental Determinants of Health, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: hadi_nut@yahoo.com.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Moludi', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Rezaeian', 'Affiliation': 'Research Center for Environmental Determinants of Health, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Houshang', 'Initials': 'H', 'LastName': 'Amirian', 'Affiliation': 'Department of Psychiatry, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Ali Akbar', 'Initials': 'AA', 'LastName': 'Foroughi', 'Affiliation': 'Department of Clinical Psychology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Seyed Mostafa', 'Initials': 'SM', 'LastName': 'Nachvak', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Goharmehr', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Roghayeh', 'Initials': 'R', 'LastName': 'Mostafai', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110986']
1804,32968947,"Placebo-Controlled, Double-Blind Study of Empagliflozin (EMPA) and Implantable Cardioverter-Defibrillator (EMPA-ICD) in Patients with Type 2 Diabetes (T2DM): Rationale and Design.","INTRODUCTION


Type 2 diabetes (T2DM) is associated with cardiovascular death, including sudden cardiac death due to arrhythmias. Patients with an implantable cardioverter-defibrillator (ICD) are also at high risk of developing a clinically significant ventricular arrhythmia. It has been reported that sodium-glucose cotransporter 2 (SGLT2) inhibitors can reduce cardiovascular deaths; however, the physiological mechanisms of this remain unclear. It is, however, well known that SGLT2 inhibitors increase blood ketone bodies, which have been suggested to have sympatho-suppressive effects. Empagliflozin (EMPA) is an SGLT2 inhibitor. The current clinical trial titled ""Placebo-controlled, double-blind study of empagliflozin (EMPA) and implantable cardioverter-defibrillator (EMPA-ICD) in patients with type 2 diabetes (T2DM)"" was designed to investigate the antiarrhythmic effects of EMPA.
METHODS


The EMPA-ICD study is a prospective, multicenter, placebo-controlled, double-blind, randomized, investigator-initiated clinical trial currently in progress. A total of 210 patients with T2DM (hemoglobin A1c 6.5-10.0%) will be randomized (1:1) to receive once-daily placebo or EMPA, 10 mg, for 24 weeks. The primary endpoint is the number of clinically significant ventricular arrhythmias for 24 weeks before and 24 weeks after study drug administration, as documented by the ICD. The secondary endpoints of the study are the change from baseline concentrations in blood ketone and catecholamine 24 weeks after drug treatment.
CONCLUSION


The EMPA-ICD study is the first clinical trial to assess the effect of an SGLT2 inhibitor on clinically significant ventricular arrhythmias in patients with T2DM and an ICD.
TRIAL REGISTRATION


Unique trial number, jRCTs031180120 ( https://jrct.niph.go.jp/latest-detail/jRCTs031180120 ).",2020,"The primary endpoint is the number of clinically significant ventricular arrhythmias for 24 weeks before and 24 weeks after study drug administration, as documented by the ICD.","['Patients with Type\xa02 Diabetes (T2DM', 'patients with type\xa02 diabetes (T2DM', '210 patients with T2DM (hemoglobin', 'patients with T2DM and an ICD']","['placebo or EMPA', 'empagliflozin (EMPA) and implantable cardioverter-defibrillator (EMPA-ICD', 'Empagliflozin (EMPA', 'Implantable Cardioverter-Defibrillator (EMPA-ICD', 'placebo', 'implantable cardioverter-defibrillator (ICD', 'Placebo', 'SGLT2 inhibitor']","['number of clinically significant ventricular arrhythmias', 'cardiovascular deaths', 'blood ketone and catecholamine 24\xa0weeks after drug treatment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",210.0,0.405225,"The primary endpoint is the number of clinically significant ventricular arrhythmias for 24 weeks before and 24 weeks after study drug administration, as documented by the ICD.","[{'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Fujiki', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Iijima', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Okabe', 'Affiliation': 'Department of Cardiology, Tachikawa General Hospital, Nagaoka, Niigata, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Niwano', 'Affiliation': 'Cardiovascular Medicine, Kitasato University, Sagamihara, Kanagawa, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Tsujita', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Shigeto', 'Initials': 'S', 'LastName': 'Naito', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi, Gunma, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Kusano', 'Affiliation': 'Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.'}, {'ForeName': 'Ritsushi', 'Initials': 'R', 'LastName': 'Kato', 'Affiliation': 'Department of Cardiology, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Nitta', 'Affiliation': 'Department of Cardiology, Sakakibara Heart Institute, Fuchu, Tokyo, Japan.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Miura', 'Affiliation': 'Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Mitsuhashi', 'Affiliation': 'Department of Cardiology, Jichi Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Tochigi, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Ieda', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Toyoaki', 'Initials': 'T', 'LastName': 'Murohara', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Niigata City General Hospital, Niigata, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomita', 'Affiliation': 'Department of Cardiology and Nephrology, Hirosaki University Graduate School of Medicine, Hirosaki, Aomori, Japan.'}, {'ForeName': 'Yasuchika', 'Initials': 'Y', 'LastName': 'Takeishi', 'Affiliation': 'Department of Cardiovascular Medicine, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Toshihisa', 'Initials': 'T', 'LastName': 'Anzai', 'Affiliation': 'Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Shimizu', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Cardiology, Pulmonology, and Nephrology, Yamagata University Faculty of Medicine, Yamagata, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Morino', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Iwate Medical University, Morioka, Iwate, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Cardiology, Graduate School of Medical Science, Kanazawa University, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tada', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Cardiovascular Medicine, Shiga University of Medical Science, Otsu, Shiga, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Yano', 'Affiliation': 'Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Maemura', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Hisako', 'Initials': 'H', 'LastName': 'Yoshida', 'Affiliation': 'Department of Medial Statistics, Osaka City University, Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ota', 'Affiliation': 'Data Management Group, Department of Clinical Research Support, Center for Clinical Research and Innovation, Osaka City University Hospital, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tanaka', 'Affiliation': 'Clinical and Translational Research Center, Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Kitamura', 'Affiliation': 'Clinical and Translational Research Center, Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Yoshifusa', 'Initials': 'Y', 'LastName': 'Aizawa', 'Affiliation': 'Department of Cardiology, Tachikawa General Hospital, Nagaoka, Niigata, Japan.'}, {'ForeName': 'Ippei', 'Initials': 'I', 'LastName': 'Shimizu', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Izumi', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Ozaki', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Tohru', 'Initials': 'T', 'LastName': 'Minamino', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan. t.minamino@juntendo.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00924-9']
1805,32971179,"High-intensity interval training on body composition, functional capacity and biochemical markers in healthy young versus older people.","BACKGROUND


The aim of the following study was to identify the effects of a 12-week high-intensity interval training (HIIT) program on the modification of parameters of body composition, functional capacity as well as lipid and glucose homeostasis markers in healthy young people versus older adults.
DESIGN


Experimental trial.
METHODS


Healthy young (YNG, 21 ± 1 years, BMI 26.01 ± 2.64 kg·m -2 , n = 10) and older (OLD, 66 ± 5 years, BMI 27.43 ± 3.11 kg·m -2 , n = 10) males were subjected to 12 weeks of HIIT. Prior to and immediately after the HIIT program, dual-energy X-ray absorptiometry, dominant leg strength one-repetition maximum (1-RM), maximal oxygen uptake (VO 2max ) and physical performance tests were performed. Blood samples were also taken.
RESULTS


Flexibility (P = 0.000), static balance (P = 0.004), timed up and go test (TUG) (P = 0.015), short physical performance battery (SPPB) (P = 0.005), dominant leg strength 1-RM (P = 0.012), and VO 2max  (P = 0.000) were better in YNG versus OLD. HIIT improved the % whole-body fat mass (P = 0.031), leg lean mass (P = 0.047), dominant leg strength 1-RM (P = 0.025), VO 2max  (P = 0.000), fasting cholesterol (P = 0.017) and fasting glucose (P = 0.006). TUG was improved by the training only in the OLD group (P = 0.016), but insulin (P = 0.002) and the homeostasis model assessment - insulin sensitivity (HOMA-IS) (P = 0.000) decreased only in the YNG group. HOMA-IS was correlated positive with BMI (R = 0.474, P = 0.035) and with whole-body fat mass (R = 0.517, P = 0.019).
CONCLUSIONS


HIIT for 12 weeks improves parameters of body composition, functional capacity and fasting serum lipid and glucose homeostasis markers in healthy young and older participants. Young people are shown as benefiting more.",2020,"HIIT improved the 1-RM dominant leg strength (P = 0.025), VO 2max  (P = 0.000), % whole-body fat mass (P = 0.031), leg lean mass (P = 0.047), fasting cholesterol (P = 0.017) and fasting glucose (P = 0.006).","['Healthy young (YNG, 21\u202f±\u202f1\u202fyears, BMI 26.01\u202f±\u202f2.64, n\u202f=\u202f10) and older (OLD, 66\u202f±\u202f5\u202fyears, BMI 27.43\u202f±\u202f3.11, n\u202f=\u202f10) males', 'healthy young and older participants', 'healthy young versus older people', 'healthy young people vs older adults']","['high-intensity interval training (HIIT) program', 'High-intensity interval training']","['homeostasis model assessment - insulin sensitivity (HOMA-IS', 'HOMA-IS', 'repetition maximum (1-RM) dominant leg strength, maximal oxygen uptake (VO 2max ) and functional capacity tests', 'TUG', 'static balance', 'body composition, functional capacity and biochemical markers', 'body composition, functional capacity and fasting serum lipid and glucose homeostasis markers', 'Flexibility', 'leg lean mass', 'body composition, aerobic capacity, functional capacity as well as lipid and glucose homeostasis markers', 'timed up and go test (TUG', '1-RM dominant leg strength', 'physical performance', 'VO 2max', 'fasting cholesterol', 'fasting glucose']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",,0.0125358,"HIIT improved the 1-RM dominant leg strength (P = 0.025), VO 2max  (P = 0.000), % whole-body fat mass (P = 0.031), leg lean mass (P = 0.047), fasting cholesterol (P = 0.017) and fasting glucose (P = 0.006).","[{'ForeName': 'Gabriel Nasri', 'Initials': 'GN', 'LastName': 'Marzuca-Nassr', 'Affiliation': 'Departamento de Medicina Interna, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile; Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile. Electronic address: gabriel.marzuca@ufrontera.cl.'}, {'ForeName': 'Macarena', 'Initials': 'M', 'LastName': 'Artigas-Arias', 'Affiliation': 'Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile; Departamento de Procesos Terapéuticos, Facultad de Ciencias de la Salud, Universidad Católica de Temuco, Temuco, Chile.'}, {'ForeName': 'María Angélica', 'Initials': 'MA', 'LastName': 'Olea', 'Affiliation': 'Departamento de Educación Física, Deporte y Recreación, Facultad de Educación, Ciencias Sociales y Humanidades, Universidad de la Frontera, Temuco, Chile.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'SanMartín-Calísto', 'Affiliation': 'Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Nolberto', 'Initials': 'N', 'LastName': 'Huard', 'Affiliation': 'Centro de Biología Molecular y Farmacogenética, Departamento de Ciencias Básicas, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Durán-Vejar', 'Affiliation': 'Carrera de Kinesiología, Facultad de Medicina, Universidad de La Frontera, Chile.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Beltrán-Fuentes', 'Affiliation': 'Carrera de Kinesiología, Facultad de Medicina, Universidad de La Frontera, Chile.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Muñoz-Fernández', 'Affiliation': 'Carrera de Kinesiología, Facultad de Medicina, Universidad de La Frontera, Chile.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Alegría-Molina', 'Affiliation': 'Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Sapunar', 'Affiliation': 'Departamento de Medicina Interna, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Salazar', 'Affiliation': 'Centro de Biología Molecular y Farmacogenética, Departamento de Ciencias Básicas, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}]",Experimental gerontology,['10.1016/j.exger.2020.111096']
1806,32971262,Another's pain in my brain: No evidence that placebo analgesia affects the sensory-discriminative component in empathy for pain.,"The shared representations account of empathy suggests that sharing other people's emotions relies on neural processes similar to those engaged when directly experiencing such emotions. Recent research corroborated this by showing that placebo analgesia induced for first-hand pain resulted in reduced pain empathy and decreased activation in shared neural networks. However, those studies did not report any placebo-related variation of somatosensory engagement during pain empathy. The experimental paradigms used in these studies did not direct attention towards a specific body part in pain, which may explain the absence of effects for somatosensation. The main objective of this preregistered study was to implement a paradigm overcoming this limitation, and to investigate whether placebo analgesia may also modulate the sensory-discriminative component of empathy for pain. We induced a localized, first-hand placebo analgesia effect in the right hand of 45 participants by means of a placebo gel and conditioning techniques, and compared this to the left hand as a control condition. Participants underwent a pain task in the MRI scanner, receiving painful or non-painful electrical stimulation on their left or right hand, or witnessing another person receiving such stimulation. In contrast to a robust localized placebo analgesia effect for self-experienced pain, the empathy condition showed no differences between the two hands, neither for behavioral nor neural responses. We thus report no evidence for somatosensory sharing in empathy, while replicating previous studies showing overlapping brain activity in the affective-motivational component for first-hand and empathy for pain. Hence, in a more rigorous test aiming to overcome limitations of previous work, we again find no causal evidence for the engagement of somatosensory sharing in empathy. Our study refines the understanding of the neural underpinnings of empathy for pain, and the use of placebo analgesia in investigating such models.",2020,"In contrast to a robust localized placebo analgesia effect for self-experienced pain, the empathy condition showed no differences between the two hands, neither for behavioral nor neural responses.","[""Another's pain in my brain"", '45 participants by means of a']","['placebo', 'pain task in the MRI scanner, receiving painful or non-painful electrical stimulation on their left or right hand, or witnessing another person receiving such stimulation', 'placebo gel and conditioning techniques']","['behavioral nor neural responses', 'pain empathy']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}]",45.0,0.195586,"In contrast to a robust localized placebo analgesia effect for self-experienced pain, the empathy condition showed no differences between the two hands, neither for behavioral nor neural responses.","[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Hartmann', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Rütgen', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Riva', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria. Electronic address: claus.lamm@univie.ac.at.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117397']
1807,32971774,Pre-Sleep Low Glycemic Index Modified Starch Does Not Improve Next-Morning Fuel Selection or Running Performance in Male and Female Endurance Athletes.,"To determine the effects of pre-sleep supplementation with a novel low glycemic index (LGI) carbohydrate (CHO) on next-morning substrate utilization, gastrointestinal distress (GID), and endurance running performance (5-km time-trial, TT). Using a double-blind, randomized, placebo (PLA) controlled, crossover design, trained participants ( n  = 14; 28 ± 9 years, 8/6 male/female, 55 ± 7 mL/kg/min) consumed a LGI, high glycemic index (HGI), or 0 kcal PLA supplement ≥ 2 h after their last meal and <30 min prior to sleep. Upon arrival, resting energy expenditure (REE), substrate utilization, blood glucose, satiety, and GID were assessed. An incremental exercise test (IET) was performed at 55, 65, and 75% peak volume of oxygen consumption (VO 2peak ) with GID, rating of perceived exertion (RPE) and substrate utilization recorded each stage. Finally, participants completed the 5-km TT. There were no differences in any baseline measure. During IET, CHO utilization tended to be greater with LGI (PLA, 56 ± 11; HGI, 60 ± 14; LGI, 63 ± 14%,  p  = 0.16,  η 2  = 0.14). GID was unaffected by supplementation at any point ( p  > 0.05). Performance was also unaffected by supplement (PLA, 21.6 ± 9.5; HGI, 23.0 ± 7.8; LGI, 24.1 ± 4.5 min,  p  = 0.94,  η 2  = 0.01). Pre-sleep CHO supplementation did not affect next-morning resting metabolism, BG, GID, or 5-km TT performance. The trend towards higher CHO utilization during IET after pre-sleep LGI, suggests that such supplementation increases morning CHO availability.",2020,"Pre-sleep CHO supplementation did not affect next-morning resting metabolism, BG, GID, or 5-km TT performance.","['trained participants ( n  = 14; 28 ± 9 years, 8/6 male/female, 55 ± 7 mL/kg/min) consumed a', 'Male and Female Endurance Athletes']","['pre-sleep supplementation with a novel low glycemic index (LGI) carbohydrate (CHO', 'Pre-Sleep Low Glycemic Index Modified Starch', 'placebo', 'LGI, high glycemic index (HGI), or 0 kcal PLA supplement ≥ 2 h after their last meal and <30 min prior to sleep', 'Pre-sleep CHO supplementation']","['Performance', 'next-morning substrate utilization, gastrointestinal distress (GID), and endurance running performance (5-km time-trial, TT', 'oxygen consumption (VO 2peak ) with GID, rating of perceived exertion (RPE) and substrate utilization recorded each stage', 'CHO utilization', 'GID', 'next-morning resting metabolism, BG, GID, or 5-km TT performance', 'morning CHO availability', 'Upon arrival, resting energy expenditure (REE), substrate utilization, blood glucose, satiety, and GID']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0548823', 'cui_str': 'Distress gastrointestinal'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}]",,0.412373,"Pre-sleep CHO supplementation did not affect next-morning resting metabolism, BG, GID, or 5-km TT performance.","[{'ForeName': 'Monique D', 'Initials': 'MD', 'LastName': 'Dudar', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Emilie D', 'Initials': 'ED', 'LastName': 'Bode', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Karly R', 'Initials': 'KR', 'LastName': 'Fishkin', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Rochelle A', 'Initials': 'RA', 'LastName': 'Brown', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Madeleine M', 'Initials': 'MM', 'LastName': 'Carre', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Noa R', 'Initials': 'NR', 'LastName': 'Mills', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ormsbee', 'Affiliation': 'Department of Nutrition, Food, and Exercise Sciences, Institute of Sport Sciences and Medicine, Florida State University, Tallahassee, FL 32306, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Ives', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}]",Nutrients,['10.3390/nu12092888']
1808,32978121,Does the effect of lifestyle intervention for individuals with diabetes vary by food insecurity status? A preplanned subgroup analysis of the REAL HEALTH randomized clinical trial.,"INTRODUCTION


We aimed to test the effectiveness of a lifestyle intervention (LI) for individuals with food insecurity and type 2 diabetes.
RESEARCH DESIGN AND METHODS


Adults with type 2 diabetes, body mass index ≥25 kg/m 2  (or ≥23 kg/m 2  if Asian), hemoglobin A1c of 6.5%-11.5% (48-97 mmol/mol) and who were willing to lose 5%-7% bodyweight were enrolled in REAL HEALTH-Diabetes. This practice-based randomized clinical trial compared LI (delivered inperson or by telephone) with medical nutrition therapy (MNT) on weight loss at 6 and 12 months. Two or more affirmative responses on the six-item US Department of Agriculture Food Security Survey Module indicated food insecurity. In this prespecified subgroup analysis, we tested using linear mixed effects models whether the intervention effect varied by food security status.
RESULTS


Of 208 participants, 13% were food insecure. Those with food insecurity were more likely to be racial/ethnic minorities (p<0.001) and have lower education (p<0.001). LI, versus MNT, led to greater weight loss at 6 months (5.1% lost vs 1.1% lost; p<0.0001) and 12 months (4.7% lost vs 2.0% lost; p=0.0005). The intervention effect was similar regardless of food security status (5.1% bodyweight lost vs 1.1% in food secure participants and 5.1% bodyweight lost vs 1.3% in food insecure participants at 6 months; 4.7% bodyweight lost vs 2.1% in food secure participants and 4.5% bodyweight lost vs 0.9% in food insecure participants at 12 months; p for interaction=0.99).
CONCLUSIONS


The REAL HEALTH-Diabetes lifestyle intervention led to meaningful weight loss for individuals with food insecurity and type 2 diabetes.
TRIAL REGISTRATION NUMBER


NCT02320253.",2020,Those with food insecurity were more likely to be racial/ethnic minorities (p<0.001) and have lower education (p<0.001).,"['individuals with diabetes vary by food insecurity status', 'Adults with type', '208 participants', 'individuals with food insecurity and type 2 diabetes']","['lifestyle intervention', 'LI (delivered inperson or by telephone) with medical nutrition therapy (MNT', 'lifestyle intervention (LI']","['weight loss', 'food security status']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1257928', 'cui_str': 'Medical Nutrition Therapy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",208.0,0.185464,Those with food insecurity were more likely to be racial/ethnic minorities (p<0.001) and have lower education (p<0.001).,"[{'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Berkowitz', 'Affiliation': 'Division of General Medicine & Clinical Epidemiology, Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Porneala', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Cromer', 'Affiliation': 'Diabetes Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wexler', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA Delahanty.linda@mgh.harvard.edu DWEXLER@mgh.harvard.edu.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Delahanty', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA Delahanty.linda@mgh.harvard.edu DWEXLER@mgh.harvard.edu.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001514']
1809,32978182,Effects of home-based mirror therapy and cognitive therapeutic exercise on the improvement of the upper extremity functions in patients with severe hemiparesis after a stroke: a protocol for a pilot randomised clinical trial.,"INTRODUCTION


Neuroplasticity is defined as the capacity of the brain to reorganise new neuronal pathways. Mirror therapy (MT) and cognitive therapeutic exercise (CTE) are two neurorehabilitation techniques based on neuroplasticity and designed to improve the motor functions of the affected upper extremity in patients with severe hemiparesis after a stroke. Home-based interventions are an appropriate alternative to promote independence and autonomy. The objective of this study is to evaluate which of these techniques, MT and CTE, combined with task-oriented training, is more effective in functional recovery and movement patterns of the upper extremities in patients with severe hemiparesis after a stroke.
METHODS AND ANALYSIS


This is a home-based, single-blind, controlled, randomised clinical trial with three parallel arms, including 154 patients who had a stroke aged above 18 years. The primary outcome will be the functionality of the affected upper extremity measured using the Fugl-Meyer Assessment. Secondary variables will include cognitive performance, emotional state, quality of life and activities of daily living. During 6 weeks, one of the intervention groups will receive a treatment based on MT and the other one on CTE, both combined with task-oriented training. No additional interventions will be provided to the control group. To assess the progress of patients who had a stroke in the subacute phase, all variables will be evaluated at different visits: initial (just before starting treatment and 4 weeks post-stroke), post-intervention (6 weeks after initial) and follow-up (6 months).
ETHICS AND DISSEMINATION


This protocol has been approved by the Institutional Review Board (CEIm-2.134/2.019) and registered at ClinicalTrials.gov (NCT04163666). The results will be disseminated through open-access peer-reviewed journals, conference presentation, broadcast media and a presentation to stakeholders. These study results will provide relevant and novel information on effective neurorehabilitation strategies and improve the quality of intervention programmes aimed at patients after a stroke.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov (NCT04163666).",2020,Mirror therapy (MT) and cognitive therapeutic exercise (CTE) are two neurorehabilitation techniques based on neuroplasticity and designed to improve the motor functions of the affected upper extremity in patients with severe hemiparesis after a stroke.,"['154 patients who had a stroke aged above 18 years', 'patients with severe hemiparesis after a stroke']","['home-based mirror therapy and cognitive therapeutic exercise', 'Mirror therapy (MT) and cognitive therapeutic exercise (CTE', 'MT and the other one on CTE, both combined with task-oriented training', 'MT and CTE, combined with task-oriented training']","['cognitive performance, emotional state, quality of life and activities of daily living', 'functionality of the affected upper extremity measured using the Fugl-Meyer Assessment']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",154.0,0.129301,Mirror therapy (MT) and cognitive therapeutic exercise (CTE) are two neurorehabilitation techniques based on neuroplasticity and designed to improve the motor functions of the affected upper extremity in patients with severe hemiparesis after a stroke.,"[{'ForeName': 'Josefa', 'Initials': 'J', 'LastName': 'Gonzalez-Santos', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Soto-Camara', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain rscamara@ubu.es.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Rodriguez-Fernández', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Jimenez-Barrios', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain.'}, {'ForeName': 'Jeronimo', 'Initials': 'J', 'LastName': 'Gonzalez-Bernal', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Collazo-Riobo', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Jahouh', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Bravo-Anguiano', 'Affiliation': 'Neurology, Burgos University Hospital, Burgos, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Trejo-Gabriel-Galan', 'Affiliation': 'Neurology, Burgos University Hospital, Burgos, Spain.'}]",BMJ open,['10.1136/bmjopen-2019-035768']
1810,32978722,A Phase I Placebo-Controlled Trial Comparing the Effects of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride Administration on Respiratory Drive.,"INTRODUCTION


Buprenorphine is a partial μ-opioid receptor agonist that, unlike full μ-opioid receptor agonists, has been shown to have a ceiling effect on respiratory depression. Buprenorphine buccal film (BBF) is approved by the US Food and Drug Administration for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for whom alternative treatment options are inadequate. This study was conducted to compare the effects of BBF and immediate-release oral oxycodone hydrochloride administration on respiratory drive, as measured by the ventilatory response to hypercapnia (VRH) after drug administration.
METHODS


Subjects (N = 19) were men and women, ages 27-41 years, self-identifying as recreational opioid users who were not physically dependent on opioids as determined via a Naloxone Challenge Test. Respiratory drive was evaluated by measuring VRH through the assessment of the maximum decrease in minute ventilation (E max ) after administration of each treatment. The treatments utilized in this study included 300, 600, and 900 μg BBF; 30 and 60 mg orally administered oxycodone; and placebo (each separated by a 7-day washout period). Effects on respiratory drive were assessed using a double-blind, double-dummy, six-treatment, six-period, placebo-controlled, randomized crossover design. Statistical analyses were performed using a linear mixed-effects model.
RESULTS


The least squares mean differences in minute volume E max  (L/min, versus placebo) were as follows: 300 μg BBF (+ 1.24, P = 0.529), 600 μg BBF (+ 0.23, P = 0.908), 900 μg BBF (+ 0.93, P = 0.637), 30 mg oxycodone (- 0.79, P = 0.687), and 60 mg oxycodone (- 5.23, P = 0.010).
CONCLUSIONS


BBF did not significantly reduce respiratory drive at any dose compared with placebo, including at the maximum available prescription dose of 900 μg. Administration of oxycodone resulted in a significant dose-dependent decrease in respiratory drive. These data suggest that BBF may be a safer treatment option than full μ-opioid receptor agonists for patients with chronic pain.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT03996694.",2020,"CONCLUSIONS


BBF did not significantly reduce respiratory drive at any dose compared with placebo, including at the maximum available prescription dose of 900 μg.","['300, 600, and 900\xa0μg BBF; 30 and 60\xa0mg orally administered', 'patients with chronic pain severe', 'Subjects (N\u2009=\u200919) were men and women, ages 27-41\xa0years, self-identifying as recreational opioid users who were not physically dependent on opioids as determined via a Naloxone Challenge Test', 'patients with chronic pain']","['Buprenorphine buccal film (BBF', 'oxycodone; and placebo', 'Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride', 'Buprenorphine', 'BBF', 'oxycodone hydrochloride', 'placebo', 'oxycodone', 'Placebo']","['minute ventilation (E max ', 'ventilatory response to hypercapnia (VRH', 'respiratory drive']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C4056633', 'cui_str': 'Buprenorphine Buccal Film [Belbuca]'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C4056633', 'cui_str': 'Buprenorphine Buccal Film [Belbuca]'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0282274', 'cui_str': 'Oxycodone hydrochloride'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}]",,0.319049,"CONCLUSIONS


BBF did not significantly reduce respiratory drive at any dose compared with placebo, including at the maximum available prescription dose of 900 μg.","[{'ForeName': 'Lynn R', 'Initials': 'LR', 'LastName': 'Webster', 'Affiliation': 'PRA Health Sciences, Salt Lake City, UT, USA. WebsterLynn@prahs.com.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hansen', 'Affiliation': 'PRA Health Sciences, Salt Lake City, UT, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Cater', 'Affiliation': 'PRA Health Sciences, Salt Lake City, UT, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Smith', 'Affiliation': 'BioDelivery Sciences International, Inc., Raleigh, NC, USA.'}]",Advances in therapy,['10.1007/s12325-020-01481-0']
1811,32979515,A dyadic approach for a remote physical activity intervention in adults with Alzheimer's disease and their caregivers: Rationale and design for an 18-month randomized trial.,"Adults with Alzheimer's disease and related dementia (ADRD) and their caregivers represent a sizeable and underserved segment of the population with low levels of moderate physical activity (MPA). Options for increasing MPA in community dwelling adults with ADRD and their caregivers are limited. A home-based physical activity intervention delivered remotely via video conferencing to groups of adults with ADRD and their caregivers (RGV), represents a potentially effective approach for increasing MPA in this group. We will conduct an 18-month randomized trial (6 mos. Active intervention, 6 mos. Maintenance, 6 mos. no contact) to compare the effectiveness of the RGV approach with usual care, enhanced with caregiver support (EUC), for increasing MPA in 100 community dwelling adults with ADRD and their caregiver. The primary aim is to compare MPA (min/wk.), assessed by accelerometer, across the 6-mo. active intervention in adults with ADRD randomized to RGV or EUC. Secondarily, we will compare adults with ADRD and their caregivers randomized to RGV or ECU on the following outcomes across 18 mos.: MPA (min/wk.), sedentary time (min/wk.), percentage meeting 150 min/wk. MPA goal, functional fitness, activities of daily living, quality of life, residential transitions, cognitive function, and caregiver burden. Additionally, we will evaluate the influence of age, sex, BMI, attendance (exercise/support sessions), use of recorded sessions, self-monitoring, peer interactions during group sessions, caregiver support, type and quality of dyadic relationship, and number of caregivers on changes in MPA in adults with ADRD and their caregiver across 18 mos.",2020,"A home-based physical activity intervention delivered remotely via video conferencing to groups of adults with ADRD and their caregivers (RGV), represents a potentially effective approach for increasing MPA in this group.","['community dwelling adults with ADRD and their caregivers', ""Adults with Alzheimer's disease and related dementia (ADRD) and their caregivers represent a sizeable and underserved segment of the population with low levels of moderate physical activity (MPA"", 'adults with ADRD randomized to', ""adults with Alzheimer's disease and their caregivers"", '100 community dwelling adults with ADRD and their caregiver', 'adults with ADRD and their caregivers randomized to', 'adults with ADRD and their caregivers (RGV', 'adults with ADRD and their caregiver across 18 mos']","['remote physical activity intervention', 'RGV or EUC', 'RGV approach with usual care, enhanced with caregiver support (EUC', 'RGV or ECU']","['MPA goal, functional fitness, activities of daily living, quality of life, residential transitions, cognitive function, and caregiver burden']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0150162', 'cui_str': 'Caregiver support'}, {'cui': 'C0013593', 'cui_str': 'Ecuador'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",100.0,0.092155,"A home-based physical activity intervention delivered remotely via video conferencing to groups of adults with ADRD and their caregivers (RGV), represents a potentially effective approach for increasing MPA in this group.","[{'ForeName': 'Lauren T', 'Initials': 'LT', 'LastName': 'Ptomey', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: lptomey@kumc.edu.'}, {'ForeName': 'Amanda N', 'Initials': 'AN', 'LastName': 'Szabo-Reed', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: aszabo@kumc.edu.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Vidoni', 'Affiliation': 'Department of Neurology, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: evidoni@kumc.edu.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Washburn', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: rwashburn@ku.edu.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Gorczyca', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: agorczyca@ku.edu.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Little', 'Affiliation': 'Department of Educational Psychology and Leadership, Texas Tech University, 2500 Broadway, Lubbock, TX 79409, USA. Electronic address: todd.d.little@ttu.edu.'}, {'ForeName': 'Jaehoon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Educational Psychology and Leadership, Texas Tech University, 2500 Broadway, Lubbock, TX 79409, USA. Electronic address: jaehoon.lee@ttu.edu.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Helsel', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: bhelsel@kumc.edu.'}, {'ForeName': 'Kristine N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'School of Nursing, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: kwilliams1@kumc.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: jdonnelly@ku.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106158']
1812,32979521,Neural correlates of future weight loss reveal a possible role for brain-gastric interactions.,"Lifestyle dietary interventions are an essential practice in treating obesity, hence neural factors that may assist in predicting individual treatment success are of great significance. Here, in a prospective, open-label, three arms study, we examined the correlation between brain resting-state functional connectivity measured at baseline and weight loss following 6 months of lifestyle intervention in 92 overweight participants. We report a robust subnetwork composed mainly of sensory and motor cortical regions, whose edges correlated with future weight loss. This effect was found regardless of intervention group. Importantly, this main finding was further corroborated using a stringent connectivity-based prediction model assessed with cross-validation thus attesting to its robustness. The engagement of senso-motor regions in this subnetwork is consistent with the over-sensitivity to food cues theory of weight regulation. Finally, we tested an additional hypothesis regarding the role of brain-gastric interaction in this subnetwork, considering recent findings of a cortical network synchronized with gastric activity. Accordingly, we found a significant spatial overlap with the subnetwork reported in the present study. Moreover, power in the gastric basal electric frequency within our reported subnetwork negatively correlated with future weight loss. This finding was specific to the weight loss related subnetwork and to the gastric basal frequency. These findings should be further corroborated by combining direct recordings of gastric activity in future studies. Taken together, these intriguing results may have important implications for our understanding of the etiology of obesity and the mechanism of response to dietary intervention.",2020,This effect was found regardless of intervention group.,['92 overweight participants'],['Lifestyle dietary interventions'],['brain resting-state functional connectivity'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",92.0,0.0170556,This effect was found regardless of intervention group.,"[{'ForeName': 'Gidon', 'Initials': 'G', 'LastName': 'Levakov', 'Affiliation': 'Department of Brain and Cognitive Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel. Electronic address: gidonle@post.bgu.ac.il.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Kaplan', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Yaskolka Meir', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Ehud', 'Initials': 'E', 'LastName': 'Rinott', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Tsaban', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Zelicha', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Nachshon', 'Initials': 'N', 'LastName': 'Meiran', 'Affiliation': 'Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Psychology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Shelef', 'Affiliation': 'Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Diagnostic Imaging, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Shai', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Galia', 'Initials': 'G', 'LastName': 'Avidan', 'Affiliation': 'Department of Brain and Cognitive Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Psychology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117403']
1813,32979620,"Prophylactic use of tranexamic acid for prevention of bleeding during transbronchial lung biopsies - A randomized, double-blind, placebo-controlled trial.","BACKGROUND


Although massive bleeding following transbronchial lung biopsies (TBLB) is rare, even minor hemorrhage may prolong the procedure and result in inadequate sampling. Tranexamic acid (TXA) is an antifibrinolytic agent, which reduces bleeding in numerous scenarios, however, its prophylactic use in mitigating post-TBLB bleeding has not been investigated. We conducted a prospective, randomized, double-blind, placebo-controlled trial to determine whether topical infusion of TXA prior to TBLB would reduce bleeding, shorten procedure duration and increase the number of biopsies obtained.
METHODS


We blindly randomized patients undergoing TBLB to receive topical TXA or placebo in the lobar bronchus prior to biopsies. Vital signs, procedure length, fluid balance (as a measure of the amount of bleeding), operator's assessment of bleeding, and number of biopsies obtained were measured. Data was analyzed using the two-tailed Student's T-Test, Chi-square or Mann-Whitney tests as appropriate.
RESULTS


Fifty patients were randomized, 26 to the TXA arm. The bleeding in the TXA group was significantly lower (P = 0.0037), with more specimens being obtained (placebo 7 (6, 9) (median and interquartile range) vs. TXA 9 (8, 10), P = 0.023) and no difference in procedure length (placebo 30 min (29.3, 34.3) vs. TXA 30 (24.8, 36), P = 0.90). There were no clinically significant adverse events in any of the groups up to one month of follow up.
CONCLUSION


Endobronchial installation of TXA prior to obtaining TBLB results in less bleeding and allows more biopsies to be obtained with no additional adverse events. The prophylactic use of TXA during TBLB may be considered as standard.",2020,"The bleeding in the TXA group was significantly lower (P = 0.0037), with more specimens being obtained (placebo 7 (6, 9) (median and interquartile range) vs. TXA 9 (8, 10), P = 0.023) and no difference in procedure length (placebo 30 min (29.3, 34.3) vs. TXA 30 (24.8, 36), P = 0.90).","['We blindly randomized patients undergoing TBLB to receive', 'Fifty patients were randomized, 26 to the TXA arm']","['Tranexamic acid (TXA', 'topical TXA or placebo', 'tranexamic acid', 'placebo', 'TXA']","['number of biopsies obtained', 'adverse events', 'procedure length', ""Vital signs, procedure length, fluid balance (as a measure of the amount of bleeding), operator's assessment of bleeding, and number of biopsies obtained"", 'bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0863477', 'cui_str': 'Transbronchial lung biopsy'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449807', 'cui_str': 'Number of biopsies'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",50.0,0.616386,"The bleeding in the TXA group was significantly lower (P = 0.0037), with more specimens being obtained (placebo 7 (6, 9) (median and interquartile range) vs. TXA 9 (8, 10), P = 0.023) and no difference in procedure length (placebo 30 min (29.3, 34.3) vs. TXA 30 (24.8, 36), P = 0.90).","[{'ForeName': 'Rottem', 'Initials': 'R', 'LastName': 'Kuint', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. Electronic address: kuint@hadassah.org.il.'}, {'ForeName': 'Liran', 'Initials': 'L', 'LastName': 'Levy', 'Affiliation': 'Institute of Pulmonary Medicine, Chaim Sheba Medical Center, The Sackler School of Medicine, Tel Aviv, Israel.'}, {'ForeName': 'Polina', 'Initials': 'P', 'LastName': 'Cohen Goichman', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Huszti', 'Affiliation': 'Biostatistics Research Unit, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Abu Rmeileh', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Ora', 'Initials': 'O', 'LastName': 'Shriki', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Avraham', 'Initials': 'A', 'LastName': 'Abutbul', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Zvi G', 'Initials': 'ZG', 'LastName': 'Fridlender', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Berkman', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106162']
1814,32945632,Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma.,"BACKGROUND


Platinum-based chemotherapy is standard-of-care first-line treatment for advanced urothelial carcinoma. However, progression-free survival and overall survival are limited by chemotherapy resistance.
METHODS


In a phase 3 trial, we randomly assigned patients with unresectable locally advanced or metastatic urothelial cancer who did not have disease progression with first-line chemotherapy (four to six cycles of gemcitabine plus cisplatin or carboplatin) to receive best supportive care with or without maintenance avelumab. The primary end point was overall survival, assessed among all patients who underwent randomization (overall population) and among those with tumors positive for programmed cell death ligand 1 (PD-L1). Secondary end points included progression-free survival and safety.
RESULTS


Among all 700 patients who underwent randomization, the addition of maintenance avelumab to best supportive care significantly prolonged overall survival as compared with best supportive care alone (control). Overall survival at 1 year was 71.3% in the avelumab group and 58.4% in the control group (median overall survival, 21.4 months vs. 14.3 months; hazard ratio for death, 0.69; 95% confidence interval [CI], 0.56 to 0.86; P = 0.001). Avelumab also significantly prolonged overall survival in the PD-L1-positive population; overall survival at 1 year was 79.1% in the avelumab group and 60.4% in the control group (hazard ratio, 0.56; 95% CI, 0.40 to 0.79; P<0.001). The median progression-free survival was 3.7 months in the avelumab group and 2.0 months in the control group in the overall population (hazard ratio for disease progression or death, 0.62; 95% CI, 0.52 to 0.75) and 5.7 months and 2.1 months, respectively, in the PD-L1-positive population (hazard ratio, 0.56; 95% CI, 0.43 to 0.73). The incidence of adverse events from any cause was 98.0% in the avelumab group and 77.7% in the control group; the incidence of adverse events of grade 3 or higher was 47.4% and 25.2%, respectively.
CONCLUSIONS


Maintenance avelumab plus best supportive care significantly prolonged overall survival, as compared with best supportive care alone, among patients with urothelial cancer who had disease that had not progressed with first-line chemotherapy. (Funded by Pfizer and Merck [Darmstadt, Germany]; JAVELIN Bladder 100 ClinicalTrials.gov number, NCT02603432.).",2020,"CONCLUSIONS


Maintenance avelumab plus best supportive care significantly prolonged overall survival, as compared with best supportive care alone, among patients with urothelial cancer who had disease that had not progressed with first-line chemotherapy.","['patients with unresectable locally advanced or metastatic urothelial cancer who did not have disease progression with first-line chemotherapy (four to six cycles of', 'patients with urothelial cancer who had disease that had not progressed with first-line chemotherapy', 'Advanced or Metastatic Urothelial Carcinoma', 'advanced urothelial carcinoma']","['Avelumab Maintenance Therapy', 'supportive care with or without maintenance avelumab', 'gemcitabine plus cisplatin or carboplatin', 'Platinum-based chemotherapy']","['progression-free survival and safety', 'Overall survival', 'incidence of adverse events', 'median progression-free survival', 'progression-free survival and overall survival', 'survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}]","[{'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",700.0,0.381542,"CONCLUSIONS


Maintenance avelumab plus best supportive care significantly prolonged overall survival, as compared with best supportive care alone, among patients with urothelial cancer who had disease that had not progressed with first-line chemotherapy.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Voog', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Caserta', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Begoña P', 'Initials': 'BP', 'LastName': 'Valderrama', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Haralabos', 'Initials': 'H', 'LastName': 'Kalofonos', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Siniša', 'Initials': 'S', 'LastName': 'Radulović', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Demey', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ullén', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Yohann', 'Initials': 'Y', 'LastName': 'Loriot', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Srikala S', 'Initials': 'SS', 'LastName': 'Sridhar', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Norihiko', 'Initials': 'N', 'LastName': 'Tsuchiya', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Kopyltsov', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bellmunt', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Jeanny B', 'Initials': 'JB', 'LastName': 'Aragon-Ching', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Laliberte', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Fowst', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Costa', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Blake-Haskins', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'di Pietro', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Grivas', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}]",The New England journal of medicine,['10.1056/NEJMoa2002788']
1815,32945775,Effect of Voluntary Participation on Mobile Health Care in Diabetes Management: Randomized Controlled Open-Label Trial.,"BACKGROUND


The role of mobile health care (mHealth) in glycemic control has been investigated, but its impact on self-management skills and its psychological aspects have not been studied.
OBJECTIVE


We evaluated the efficacy of mHealth-based diabetes self-management education and the effect of voluntary participation on its effects.
METHODS


This study was a randomized controlled open-label trial conducted for 6 months at Kangbuk Samsung Hospital. Participants in the control group (n=31) maintained their previous diabetes management strategies. Participants in the intervention group (n=41) additionally received mHealth-based diabetes self-management education through a mobile app and regular individualized feedback from health care professionals. The primary outcome was change in glycated hemoglobin (HbA 1c ) level over 6 months between the 2 groups (intervention versus control) and within each group (at 6 months versus baseline). The secondary outcomes were changes in body mass index, blood pressure, lipid profile, and questionnaire scores (the Korean version of the Summary of Diabetes Self-Care Activities Questionnaire, an Audit of Diabetes Dependent Quality of Life, the Appraisal of Diabetes Scale, and Problem Areas in Diabetes) over 6 months between groups and within each group.
RESULTS


A total of 66 participants completed this study. HbA 1c  (P=.04), total cholesterol level (P=.04), and Problem Areas in Diabetes scores (P=.02) significantly decreased; total diet (P=.03) and self-monitoring of blood glucose level scores (P=.01), based on the Summary of Diabetes Self-Care Activities Questionnaire, markedly increased within the intervention group. These significant changes were observed in self-motivated participants who were recruited voluntarily via advertisements.
CONCLUSIONS


mHealth-based diabetes self-management education was effective at improving glycemic control and diabetes self-management skills and lowering diabetes-related distress in voluntary participants.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03468283; http://clinicaltrials.gov/ct2/show/NCT03468283.",2020,"CONCLUSIONS


mHealth-based diabetes self-management education was effective at improving glycemic control and diabetes self-management skills and lowering diabetes-related distress in voluntary participants.
","['6 months at Kangbuk Samsung Hospital', 'Participants in the control group (n=31) maintained their previous diabetes management strategies', 'Diabetes Management', '66 participants completed this study']","['Voluntary Participation', 'mHealth-based diabetes self-management education', 'mHealth-based diabetes self-management education through a mobile app and regular individualized feedback from health care professionals']","['Mobile Health Care', 'total cholesterol level', 'Diabetes scores', 'glycated hemoglobin (HbA 1c ) level', 'self-monitoring of blood glucose level scores', 'Diabetes Self-Care Activities Questionnaire', 'changes in body mass index, blood pressure, lipid profile, and questionnaire scores (the Korean version of the Summary of Diabetes Self-Care Activities Questionnaire, an Audit of Diabetes Dependent Quality of Life, the Appraisal of Diabetes Scale, and Problem Areas in Diabetes']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",66.0,0.0783678,"CONCLUSIONS


mHealth-based diabetes self-management education was effective at improving glycemic control and diabetes self-management skills and lowering diabetes-related distress in voluntary participants.
","[{'ForeName': 'Da Young', 'Initials': 'DY', 'LastName': 'Lee', 'Affiliation': 'Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Hyun', 'Initials': 'SH', 'LastName': 'Yoo', 'Affiliation': 'Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyong Pil', 'Initials': 'KP', 'LastName': 'Min', 'Affiliation': 'Huraypositive Inc, Seoul, Republic of Korea.'}, {'ForeName': 'Cheol-Young', 'Initials': 'CY', 'LastName': 'Park', 'Affiliation': 'Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]",JMIR mHealth and uHealth,['10.2196/19153']
1816,32970315,"Bioequivalence Study Comparing Fixed-Dose Combination of Clopidogrel and Aspirin with Coadministration of Individual Formulations in Chinese Subjects Under Fed Conditions: A Phase I, Open-Label, Randomized, Crossover Study.","INTRODUCTION


Simultaneous administration of acetylsalicylic acid (ASA) and clopidogrel has demonstrated efficacy in the treatment of acute coronary syndrome. Clopidogrel + ASA in a fixed-dose combination (FDC) provides a pharmaceutical option to enhance adherence to the coadministration of dual antiplatelet therapy (DAPT). Herein, we evaluate the bioequivalence of enteric ASA and clopidogrel in an FDC compared with simultaneous administration of the individual formulations.
METHODS


This study is a randomized, single-center, open-label, three-sequence, three-period, two-treatment, crossover study conducted in healthy Chinese male and female subjects under fed conditions. Subjects were randomized to receive, in each period, a single dose of (1) a combination tablet containing 75-mg clopidogrel and 100-mg enteric ASA (test formulation) or (2) coadministration of one 75-mg clopidogrel tablet and one 100-mg enteric-coated ASA tablet (reference formulations) under fed conditions. Plasma samples were analyzed for ASA, salicylic acid, clopidogrel, and the clopidogrel metabolite SR26334. For ASA, the reference-scaled average bioequivalence (RSABE) analysis was conducted for C max  of ASA because within-subject standard deviation (SD W ) was ≥ 0.294 for log-transformed C max .
RESULTS


The point estimate (test/reference geometric mean ratio) was between 0.80 and 1.25, and the upper one-sided 95% confidence interval (CI) for the scaled average bioequivalence metric was ≤ 0 (-0.08). AUC of ASA as SD W  was < 0.294 for log-transformed AUC last  and AUC. Estimates of 90% CIs for log-transformed AUC last  and AUC ratios were within the bioequivalence range of 0.80 to 1.25 (0.98-1.08 and 1.00-1.10, respectively). For clopidogrel, the 90% CIs for the ratios comparing log-transformed C max , AUC last , and AUC ratios of clopidogrel following administration of test versus reference formulation were calculated using the ABE method and were well within the acceptable range of 0.80 to 1.25 (1.02-1.12, 0.92-0.99, and 0.92-0.98, respectively).
CONCLUSION


FDC of ASA and clopidogrel was bioequivalent to the simultaneous administration of the individual formulations in healthy Chinese subjects under fed conditions.
TRIAL REGISTRATION


CTR20190376.",2020,AUC of ASA as SD W  was < 0.294 for log-transformed AUC,"['healthy Chinese subjects under fed conditions', 'acute coronary syndrome', 'healthy Chinese male and female subjects under fed conditions', 'Chinese Subjects Under Fed Conditions']","['Clopidogrel and Aspirin with Coadministration of Individual Formulations', 'combination tablet containing 75-mg clopidogrel and 100-mg enteric ASA (test formulation) or (2) coadministration of one 75-mg clopidogrel tablet and one 100-mg enteric-coated ASA tablet (reference formulations) under fed conditions', 'clopidogrel', 'Clopidogrel\u2009+\u2009ASA', 'AUC', 'acetylsalicylic acid (ASA) and clopidogrel']","['AUC ratios', 'ratios comparing log-transformed C max , AUC last , and AUC ratios of clopidogrel']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1248670', 'cui_str': 'clopidogrel Oral Tablet'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]",,0.234126,AUC of ASA as SD W  was < 0.294 for log-transformed AUC,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Ming', 'Affiliation': 'Research and Development, Sanofi, New York, USA.'}, {'ForeName': 'Fangyuan', 'Initials': 'F', 'LastName': 'Kong', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Huiqiu', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Medical, Sanofi, Beijing, China.'}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Bai', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Ping', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Chunyu', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Ju', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Xinghe', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China. wangxh@bjsjth.cn.'}]",Advances in therapy,['10.1007/s12325-020-01486-9']
1817,32966722,"Lower-Dose Zinc for Childhood Diarrhea - A Randomized, Multicenter Trial.","BACKGROUND


The World Health Organization recommends 20 mg of zinc per day for 10 to 14 days for children with acute diarrhea; in previous trials, this dosage decreased diarrhea but increased vomiting.
METHODS


We randomly assigned 4500 children in India and Tanzania who were 6 to 59 months of age and had acute diarrhea to receive 5 mg, 10 mg, or 20 mg of zinc sulfate for 14 days. The three primary outcomes were a diarrhea duration of more than 5 days and the number of stools (assessed in a noninferiority analysis) and the occurrence of vomiting (assessed in a superiority analysis) within 30 minutes after zinc administration.
RESULTS


The percentage of children with diarrhea for more than 5 days was 6.5% in the 20-mg group, 7.7% in the 10-mg group, and 7.2% in the 5-mg group. The difference between the 20-mg and 10-mg groups was 1.2 percentage points (upper boundary of the 98.75% confidence interval [CI], 3.3), and that between the 20-mg and 5-mg groups was 0.7 percentage points (upper boundary of the 98.75% CI, 2.8), both of which were below the noninferiority margin of 4 percentage points. The mean number of diarrheal stools was 10.7 in the 20-mg group, 10.9 in the 10-mg group, and 10.8 in 5-mg group. The difference between the 20-mg and 10-mg groups was 0.3 stools (upper boundary of the 98.75% CI, 1.0), and that between the 20-mg and 5-mg groups was 0.1 stools (upper boundary of the 98.75% CI, 0.8), both of which were below the noninferiority margin (2 stools). Vomiting within 30 minutes after administration occurred in 19.3%, 15.6%, and 13.7% of the patients in the 20-mg, 10-mg, and 5-mg groups, respectively; the risk was significantly lower in the 10-mg group than in the 20-mg group (relative risk, 0.81; 97.5% CI, 0.67 to 0.96) and in the 5-mg group than in the 20-mg group (relative risk, 0.71; 97.5% CI, 0.59 to 0.86). Lower doses were also associated with less vomiting beyond 30 minutes after administration.
CONCLUSIONS


Lower doses of zinc had noninferior efficacy for the treatment of diarrhea in children and were associated with less vomiting than the standard 20-mg dose. (Funded by the Bill and Melinda Gates Foundation; ZTDT ClinicalTrials.gov number, NCT03078842.).",2020,"Vomiting within 30 minutes after administration occurred in 19.3%, 15.6%, and 13.7% of the patients in the 20-mg, 10-mg, and 5-mg groups, respectively; the risk was significantly lower in the 10-mg group than in the 20-mg group (relative risk, 0.81; 97.5% CI, 0.67 to 0.96) and in the 5-mg group than in the 20-mg group (relative risk, 0.71; 97.5% CI, 0.59 to 0.86).","['children with acute diarrhea', '4500 children in India and Tanzania who were 6 to 59 months of age and had acute diarrhea', 'Childhood Diarrhea ']",['zinc sulfate'],"['percentage of children with diarrhea', 'Vomiting', 'occurrence of vomiting', 'diarrhea duration of more than 5 days and the number of stools', 'mean number of diarrheal stools', 'vomiting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C4517780', 'cui_str': '4500'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0444858', 'cui_str': 'AM 6'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",4500.0,0.0686028,"Vomiting within 30 minutes after administration occurred in 19.3%, 15.6%, and 13.7% of the patients in the 20-mg, 10-mg, and 5-mg groups, respectively; the risk was significantly lower in the 10-mg group than in the 20-mg group (relative risk, 0.81; 97.5% CI, 0.67 to 0.96) and in the 5-mg group than in the 20-mg group (relative risk, 0.71; 97.5% CI, 0.59 to 0.86).","[{'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Dhingra', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Rodrick', 'Initials': 'R', 'LastName': 'Kisenge', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Sudfeld', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Pratibha', 'Initials': 'P', 'LastName': 'Dhingra', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Somji', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Arup', 'Initials': 'A', 'LastName': 'Dutta', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bakari', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Saikat', 'Initials': 'S', 'LastName': 'Deb', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Prabhabati', 'Initials': 'P', 'LastName': 'Devi', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Enju', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Aishwarya', 'Initials': 'A', 'LastName': 'Chauhan', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Jitendra', 'Initials': 'J', 'LastName': 'Kumar', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Om P', 'Initials': 'OP', 'LastName': 'Semwal', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Aboud', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Bahl', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Simon', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Duggan', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Sazawal', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Manji', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}]",The New England journal of medicine,['10.1056/NEJMoa1915905']
1818,32968274,Local exposure to inequality raises support of people of low wealth for taxing the wealthy.,"Psychological research shows that social comparison of individuals with peers or others shapes attitude formation 1,2 . Opportunities for such comparisons have increased with global inequality 3,4 ; everyday experiences can make economic disparities more salient through signals of social class 5,6 . Here we show that, among individuals with a lower socioeconomic status, such local exposure to inequality drives support for the redistribution of wealth. We designed a placebo-controlled field experiment conducted in South African neighbourhoods in which individuals with a low socioeconomic status encountered real-world reminders of inequality through the randomized presence of a high-status car. Pedestrians were asked to sign a petition to increase taxes on wealthy individuals to help with the redistribution of wealth. We found an increase of eleven percentage points in the probability of signing the petition in the presence of inequality, when taking into account the experimental placebo effect. The placebo effect suppresses the probability that an individual signs the petition in general, which is consistent with evidence that upward social comparison reduces political efficacy 4 . Measures of economic inequality were constructed at the neighbourhood level and connected to a survey of individuals with a low socioeconomic status. We found that local exposure to inequality was positively associated with support for a tax on wealthy individuals to address economic disparities. Inequality seems to affect preferences for the redistribution of wealth through local exposure. However, our results indicate that inequality may also suppress participation; the political implications of our findings at regional or country-wide scales therefore remain uncertain.",2020,We found that local exposure to inequality was positively associated with support for a tax on wealthy individuals to address economic disparities.,"['South African neighbourhoods in which individuals with a low socioeconomic status encountered real-world reminders of inequality through the randomized presence of a high-status car', 'individuals with peers or others shapes attitude formation 1,2 ']",['placebo'],[],"[{'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0242503', 'cui_str': 'Unequal'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0306861,We found that local exposure to inequality was positively associated with support for a tax on wealthy individuals to address economic disparities.,"[{'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Sands', 'Affiliation': 'Political Science, University of California, Merced, CA, USA. msands2@ucmerced.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'de Kadt', 'Affiliation': 'Political Science, University of California, Merced, CA, USA. ddekadt@ucmerced.edu.'}]",Nature,['10.1038/s41586-020-2763-1']
1819,32971040,Effects of once-weekly subcutaneous semaglutide on kidney function and safety in patients with type 2 diabetes: a post-hoc analysis of the SUSTAIN 1-7 randomised controlled trials.,"BACKGROUND


Patients with type 2 diabetes have a high risk of developing chronic kidney disease. We examined the effects of semaglutide on kidney function and safety in a large, broad type 2 diabetes population.
METHODS


We did a post-hoc analysis of 8416 patients with type 2 diabetes enrolled in the SUSTAIN 1-5 and SUSTAIN 7 randomised controlled trials, and the SUSTAIN 6 cardiovascular outcomes trial, to examine the effects of once-weekly subcutaneous semaglutide 0·5 mg and 1·0 mg versus comparators (active treatments or placebo) on estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR), and kidney adverse events. Data from SUSTAIN 1-5 and SUSTAIN 7 were pooled. eGFR and UACR were also analysed by kidney function and albuminuria status.
FINDINGS


In SUSTAIN 1-5 and SUSTAIN 7, eGFR decreased from baseline to week 12 with all active treatments; estimated treatment differences (ETDs) versus placebo were -2·15 (95% CI -3·47 to -0·83) mL/min per 1·73 m 2  with semaglutide 0·5 mg and -3·00 (-4·31 to -1·68) mL/min per 1·73 m 2  with semaglutide 1·0 mg; after week 12, eGFR plateaued. In SUSTAIN 1-5 and SUSTAIN 7, from baseline to end of treatment the decline in eGFR was greater with semaglutide than with placebo (ETD -1·58 [95% CI -2·92 to -0·25] mL/min per 1·73 m 2  with semaglutide 0·5 mg and -2·02 [-3·35 to -0·68] mL/min per 1·73 m 2  with semaglutide 1·0 mg). In SUSTAIN 6, the decline in eGFR was greater with semaglutide than with placebo from baseline to week 16 (ETD -1·29 [95% CI -2·07 to -0·51] mL/min per 1·73 m 2  with semaglutide 0·5 mg and -1·56 [-2·33 to -0·78] mL/min per 1·73 m 2  with semaglutide 1·0 mg), but not from week 16 to week 104 (1·29 [0·30 to 2·28] mL/min per 1·73 m 2  with semaglutide 0·5 mg and 2·44 [1·45 to 3·44] mL/min per 1·73 m 2  with semaglutide 1·0 mg). Overall (ie, from baseline to week 104), the eGFR decline in SUSTAIN 6 was similar between semaglutide and placebo (ETD 0·07 [95% CI -0·92 to 1·07] mL/min per 1·73 m 2  with semaglutide 0·5 mg and 0·97 [-0·03 to 1·97] mL/min per 1·73 m 2  with semaglutide 1·0 mg). In SUSTAIN 1-5, UACR ratios at end of treatment to baseline were 0·917 with semaglutide 0·5 mg, 0·836 with semaglutide 1·0 mg, and 1·239 with placebo; at end of treatment, greater reductions in UACR were observed with semaglutide versus placebo (estimated treatment ratios 0·74 [95% CI 0·64 to 0·85] for semaglutide 0·5 mg and 0·68 [0·59 to 0·78] for semaglutide 1·0 mg). In SUSTAIN 6, UACR ratios at end of treatment (week 104) to baseline were 0·973 with semaglutide 0·5 mg, 0·858 with semaglutide 1·0 mg, and 1·302 with placebo; at week 104, greater reductions in UACR were observed with semaglutide versus placebo (estimated treatment ratios 0·75 [95% CI 0·66 to 0·85] for semaglutide 0·5 mg and 0·66 [0·58 to 0·75] for semaglutide 1·0 mg). In SUSTAIN 1-7, eGFR initially declined in patients with normal kidney function (and in those with mild kidney impairment with semaglutide 1·0 mg in SUSTAIN 6), but overall (ie, by week 30 for SUSTAIN 1-5 and SUSTAIN 7, and week 104 for SUSTAIN 6), eGFR did not differ between semaglutide and placebo. In SUSTAIN 1-6, UACR decreased in patients with pre-existing microalbuminuria or macroalbuminuria at baseline; it did not change or increased in those with normoalbuminuria at baseline. Kidney adverse events were balanced between treatment groups.
INTERPRETATION


Across the SUSTAIN 1-7 trials, semaglutide was associated with initial reductions in eGFR that plateaued, and marked reductions in UACR. This post-hoc analysis suggests no increase in the risk of kidney adverse events with semaglutide versus the active comparators used across SUSTAIN 1-7.
FUNDING


Novo Nordisk.",2020,"In SUSTAIN 1-5 and SUSTAIN 7, from baseline to end of treatment the decline in eGFR was greater with semaglutide than with placebo (ETD -1·58","['Patients with type 2 diabetes', 'patients with type 2 diabetes', '8416 patients with type 2 diabetes enrolled in the SUSTAIN 1-5']","['semaglutide', '0·5 mg and -3·00 ', '0·25', 'once-weekly subcutaneous semaglutide 0·5', 'once-weekly subcutaneous semaglutide', 'placebo (ETD -1·58', '4·31 to -1·68', '1·56', ' mL/min per 1·73 m 2  with semaglutide 0·5', 'placebo', 'semaglutide 0·5 mg and -2·02', '0·51] mL/min per 1·73 m 2  with semaglutide 0·5', '2·33 to -0·78', 'mg and 1·0 mg versus comparators (active treatments or placebo']","['eGFR and UACR', 'kidney function and albuminuria status', 'decline in eGFR', 'UACR ratios', 'kidney function and safety', 'eGFR decline', 'UACR', 'eGFR', 'risk of kidney adverse events', 'Kidney adverse events', 'estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR), and kidney adverse events', 'normal kidney function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]","[{'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]",8416.0,0.16795,"In SUSTAIN 1-5 and SUSTAIN 7, from baseline to end of treatment the decline in eGFR was greater with semaglutide than with placebo (ETD -1·58","[{'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Center, Munich, Germany; Friedrich Alexander University of Erlangen-Nürnberg, Erlangen, Germany. Electronic address: johannes.mann@kms.mhn.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Idorn', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Marso', 'Affiliation': 'HCA Midwest Heart and Vascular Institute, Overland Park, Overland Park, KS, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Seufert', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Medicine II, Medical Center -Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Sayeh', 'Initials': 'S', 'LastName': 'Tadayon', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, University of Copenhagen, Hellerup, Denmark.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30313-2']
1820,32986185,Kinematics and center of axial rotation during walking after medial pivot type total knee arthroplasty.,"PURPOSE


In recent years, the medial pivot (MP) type total knee arthroplasty (TKA) implant has been developed and marketed for achieving more natural kinematics with MP. However, little is known about the pivot pattern during walking after MP type TKA. This study aimed to determine the kinematics and center of axial rotation during walking after MP type TKA.
METHODS


This randomized prospective study enrolled 40 patients with MP type TKA, 20 with cruciate-substituting TKA (MP-CS group), 20 with posterior-stabilized TKA (MP-PS group), and 10 healthy volunteers (control group). The kinematics and center of axial rotation during overground walking were measured by a three-dimensional motion analysis system. The six-degrees-of-freedom kinematics of the knee were calculated by the point cluster method.
RESULTS


The amount of change in knee flexion in early stance phase was significantly lower in the MP-CS and MP-PS groups than in the control group. The femur showed anterior translation during early stance phase in all three groups. The median center of axial rotation in the transverse plane was predominantly on the lateral side of the knee during stance in all groups.
CONCLUSIONS


Kinematics during gait are thought to be determined by physical posture, the kinetic chain during weight-bearing, and the kinematic features of adjacent structures, such as the behavior of the biarticular muscles. MP-CS and MP-PS did not necessarily induce rotational motion centered on the medial ball-in-socket component during walking; translational and lateral pivoting movements were also observed. Long-term follow-up is needed to monitor for polyethylene wear and implant loosening.",2020,The amount of change in knee flexion in early stance phase was significantly lower in the MP-CS and MP-PS groups than in the control group.,"['40 patients with MP type TKA, 20 with cruciate-substituting TKA (MP-CS group), 20 with posterior-stabilized TKA (MP-PS group), and 10 healthy volunteers (control group', 'after medial pivot type total knee arthroplasty']",['axial rotation during walking'],"['knee flexion', 'median center of axial rotation', 'rotational motion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0026597', 'cui_str': 'Motion'}]",40.0,0.0428394,The amount of change in knee flexion in early stance phase was significantly lower in the MP-CS and MP-PS groups than in the control group.,"[{'ForeName': 'Kota', 'Initials': 'K', 'LastName': 'Miura', 'Affiliation': 'Department of Rehabilitation, Hakodate Orthopedics Clinic, 2-115, Ishikawa-cho, Hakodate-shi, Hokkaido, 041-0802, Japan. kouta@hakodate-seikei.com.'}, {'ForeName': 'Yasumitsu', 'Initials': 'Y', 'LastName': 'Ohkoshi', 'Affiliation': 'Department of Orthopedic Surgery, Hakodate Orthopedics Clinic, Hakodate, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Ino', 'Affiliation': 'Department of Rehabilitation, Hakodate Orthopedics Clinic, 2-115, Ishikawa-cho, Hakodate-shi, Hokkaido, 041-0802, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Ukishiro', 'Affiliation': 'Department of Rehabilitation, Hakodate Orthopedics Clinic, 2-115, Ishikawa-cho, Hakodate-shi, Hokkaido, 041-0802, Japan.'}, {'ForeName': 'Kensaku', 'Initials': 'K', 'LastName': 'Kawakami', 'Affiliation': 'Department of Production Systems Eng., National Institute of Technology, Hakodate College, Hakodate, Japan.'}, {'ForeName': ""Sho'ji"", 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Department of Complex and Intelligent Systems, Future University Hakodate, Hakodate, Japan.'}, {'ForeName': 'Ko', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Department of Orthopedic Surgery, Hakodate Orthopedics Clinic, Hakodate, Japan.'}, {'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Maeda', 'Affiliation': 'Department of Orthopedic Surgery, Hakodate Orthopedics Clinic, Hakodate, Japan.'}]",Journal of experimental orthopaedics,['10.1186/s40634-020-00286-y']
1821,32989891,"Dentistry students' experiences, engagement and perception of biochemistry within the dental curriculum and beyond.","INTRODUCTION/OBJECTIVES


Basic knowledge at the molecular level is necessary to care for the orofacial complex as part of the whole body. Many undergraduate dentistry students struggle to engage with biochemistry during the degree due to difficulty in appreciating the relevance of biochemistry to clinical practice. This study investigated student experiences, perception and engagement with biochemistry as part of the dental curriculum and explored how the teaching of biochemistry might be further developed.
METHODS


Focus groups were conducted with 21 participants, in groups of four to six students from the 3rd year to 5th year, as well as with recent graduates and post-graduate students from a prominent Australasian dental school. Data were analysed using a general inductive approach.
RESULTS


Focus group participants viewed the oral biochemistry module as well organised and professionally run. However, participants reported that the large amount of material taught in the module made them feel overwhelmed and demotivated. Biochemistry was regarded by undergraduate participants as relevant to dental practice, but graduate participants thought it was only relevant to those sitting examinations for further training. Biochemistry was perceived as most relevant to dental research and expanding scientific literacy.
DISCUSSION/CONCLUSIONS


Participants in this study suggested that reducing the amount of material taught, focusing on dentally relevant biochemical concepts and overtly stating the connection of biochemistry to clinical practice could increase engagement and enhance the module within the dental curriculum.",2020,"Biochemistry was regarded by undergraduate participants as relevant to dental practice, but graduate participants thought it was only relevant to those sitting examinations for further training.","['undergraduate participants as relevant to dental practice, but graduate participants thought it was only relevant to those sitting examinations for further training', 'Focus groups were conducted with 21 participants, in groups of four to six students from the 3 rd  to 5th year, as well as with recent graduates and post-graduate students from a prominent Australasian dental school']",[],[],"[{'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0036376', 'cui_str': 'Dental School'}]",[],[],21.0,0.0234041,"Biochemistry was regarded by undergraduate participants as relevant to dental practice, but graduate participants thought it was only relevant to those sitting examinations for further training.","[{'ForeName': 'Karla Mariah Yumul', 'Initials': 'KMY', 'LastName': 'Youhanna', 'Affiliation': 'Department of Oral Sciences, Sir John Walsh Research Institute, Faculty of Dentistry, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Adam', 'Affiliation': 'Department of Oral Sciences, Sir John Walsh Research Institute, Faculty of Dentistry, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Monk', 'Affiliation': 'Department of Oral Sciences, Sir John Walsh Research Institute, Faculty of Dentistry, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Loch', 'Affiliation': 'Department of Oral Sciences, Sir John Walsh Research Institute, Faculty of Dentistry, University of Otago, Dunedin, New Zealand.'}]",European journal of dental education : official journal of the Association for Dental Education in Europe,['10.1111/eje.12607']
1822,32966959,Within-person networks of clinical features of social anxiety disorder during cognitive and interpersonal therapy.,"Analysis of longitudinal within-person networks over the course of therapy allows an identification of possible targets of treatment. This study examined within-person networks of clinical features in social anxiety disorder (SAD) patients during cognitive (CT) and interpersonal (IPT) therapy. Patients (n = 80) were randomized to either CT or IPT in a 10 week residential program. They completed a measure of clinical features two times a week. The 60 (75 %) patients who had completed at least 18 measurements were included in the analyses. The multilevel vector autoregressive (mlVAR) model was used to analyze the data, producing a temporal, contemporaneous, and between-person network. In the temporal network and as expected, more homework compliance in a half-week predicted less social anxiety and less social avoidance the subsequent half-week. Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus. Unexpectedly, less social avoidance predicted more self-focus and less self-focus predicted less social function and social joy. In the contemporaneous network, self-focus, anxiety and avoidance displayed a conditional independence structure. The estimated temporal network suggests that homework compliance and social function are promising targets of treatment.",2020,"Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus.","['social anxiety disorder (SAD) patients during cognitive (CT) and interpersonal (IPT) therapy', 'The 60 (75 %) patients who had completed at least 18 measurements were included in the analyses', 'Patients (n = 80']","['cognitive and interpersonal therapy', 'CT or IPT']","['social function and social joy', 'social anxiety', 'social avoidance', 'homework compliance']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0589414', 'cui_str': 'Homework'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",80.0,0.0147056,"Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus.","[{'ForeName': 'Asle', 'Initials': 'A', 'LastName': 'Hoffart', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Center, Badeveien 287, N-3370, Vikersund, Norway; Department of Psychology, University of Oslo, PB 1094, Blindern, N-0317, Oslo, Norway. Electronic address: asle.hoffart@modum-bad.no.'}, {'ForeName': 'Sverre Urnes', 'Initials': 'SU', 'LastName': 'Johnson', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Center, Badeveien 287, N-3370, Vikersund, Norway; Department of Psychology, University of Oslo, PB 1094, Blindern, N-0317, Oslo, Norway. Electronic address: Sverre.Johnson@modum-bad.no.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102312']
1823,32968936,Effectiveness of Atorvastatin in the Treatment of Asymptomatic Heart Failure After Myocardial Infarction: A Clinical Study.,"INTRODUCTION


Silent heart failure after myocardial infarction has not been effectively treated. Atorvastatin has certain efficacy in the treatment of heart failure. Our clinical study aimed to investigate the effectiveness of atorvastatin in patients with asymptomatic heart failure after myocardial infarction.
METHODS


A total of 162 patients with asymptomatic heart failure after myocardial infarction in our hospital from August 2018 to August 2019 were randomly divided into the observation group (81 cases were treated with atorvastatin on the basis of routine therapy) and the control group (81 cases were treated with routine symptomatic treatment). The clinical curative effect, the level of related inflammatory cytokines, cardiac function index, and vascular endothelial function were compared between the two groups.
RESULTS


Before intervention, there was no significant difference in tumor necrosis factor (TNFα), high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), plasma N-terminal B-type natriuretic peptide (NT-ProBNP), left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter (LVEDD), left ventricular end systolic diameter (LVESD), left ventricular posterior wall thickness (LVPWT), asymmetric dimethyarginine (ADMA), activity of nitric oxide synthase (NOS), nitric oxide (NO) and flow-mediated dilation (FMD) between the two groups. After intervention, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD were improved in both groups. The clinical curative effect, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD in the observation group showed significantly greater results than those in the control group (P < 0.05).
CONCLUSION


Atorvastatin exerted a great effect in treating asymptomatic heart failure after myocardial infarction, which can evidently reduce the level of related inflammatory cytokines, improve cardiac function, and regulate vascular endothelial function. Hence, atorvastatin is considered a valid and alternative approach in clinical practice.",2020,"After intervention, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD were improved in both groups.","['Asymptomatic Heart Failure', 'heart failure', 'After Myocardial Infarction', 'patients with asymptomatic heart failure after myocardial infarction', '162 patients with asymptomatic heart failure after myocardial infarction in our hospital from August 2018 to August 2019']","['Atorvastatin', 'atorvastatin']","['clinical curative effect, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD', 'level of related inflammatory cytokines, cardiac function index, and vascular endothelial function', 'TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD', 'tumor necrosis factor (TNFα), high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), plasma N-terminal B-type natriuretic peptide (NT-ProBNP), left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter (LVEDD), left ventricular end systolic diameter (LVESD), left ventricular posterior wall thickness (LVPWT), asymmetric dimethyarginine (ADMA), activity of nitric oxide synthase (NOS), nitric oxide (NO) and flow-mediated dilation (FMD']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0132555', 'cui_str': 'Nitric-oxide synthase'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",162.0,0.0159963,"After intervention, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD were improved in both groups.","[{'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Bai', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Xiao-Ran', 'Initials': 'XR', 'LastName': 'Cui', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Yang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China. 13933058601@163.com.'}, {'ForeName': 'Ji-Dong', 'Initials': 'JD', 'LastName': 'Zhang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}]",Advances in therapy,['10.1007/s12325-020-01441-8']
1824,32975679,"Effect of Empagliflozin on Liver Steatosis and Fibrosis in Patients With Non-Alcoholic Fatty Liver Disease Without Diabetes: A Randomized, Double-Blind, Placebo-Controlled Trial.","INTRODUCTION


Despite the high prevalence of non-alcoholic fatty liver disease (NAFLD) and its associated co-morbidities, no efficient treatment in a high percentage of individuals is available. Beneficial effects of sodium-glucose co-transporter 2 inhibitors on fatty liver have been investigated in people with type 2 diabetes (T2DM). The aim of this study was to explore the effect of empagliflozin on liver steatosis and fibrosis in patients with NAFLD without T2DM.
METHODS


In this prospective randomized, double-blind, placebo-controlled clinical trial, participants with NAFLD were randomized to empagliflozin (10 mg/day) (n = 43) or placebo (n = 47) for 24 weeks. Hepatic steatosis and fibrosis were assessed using transient elastography to measure the controlled attenuation parameter (CAP) and liver stiffness measurement (LSM). The primary outcome was the change in CAP score at 24 weeks.
RESULTS


There was significant decrease in CAP score in both groups but no significant difference was observed between the two groups (P = 0.396). LSM was significantly decreased in the empagliflozin-treated group (6.03 ± 1.40 to 5.33 ± 1.08 kPa; P = 0.001), while no change was found in the placebo group. In subgroups analysis of patients with significant steatosis at baseline (CAP ≥ 302 dB/m), steatosis significantly improved in the empagliflozin group (37.2% vs. 17%; P = 0.035). There was a significant decrease in the grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels in the empagliflozin group, while no changes were observed in the placebo group.
CONCLUSIONS


Empagliflozin improves liver steatosis and, more importantly, measures of liver fibrosis in patients with NAFLD without T2DM.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, IRCT20190122042450N1.",2020,"There was a significant decrease in the grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels in the empagliflozin group, while no changes were observed in the placebo group.
","['people with type\xa02 diabetes (T2DM', 'Without Diabetes', 'participants with NAFLD', '302\xa0dB/m', 'Patients With Non-Alcoholic Fatty Liver Disease', 'patients with NAFLD without T2DM', 'patients with significant steatosis at baseline (CAP\u2009≥']","['empagliflozin', 'placebo', 'sodium-glucose co-transporter\xa02 inhibitors', 'Empagliflozin', 'Placebo']","['change in CAP score', 'controlled attenuation parameter (CAP) and liver stiffness measurement (LSM', 'Hepatic steatosis and fibrosis', 'grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels', 'Liver Steatosis and Fibrosis', 'LSM', 'liver fibrosis', 'liver steatosis and fibrosis', 'liver steatosis', 'CAP score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}]",,0.63044,"There was a significant decrease in the grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels in the empagliflozin group, while no changes were observed in the placebo group.
","[{'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Taheri', 'Affiliation': 'Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Malek', 'Affiliation': 'Research Center for Prevention of Cardiovascular Disease, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran. malek.m@iums.ac.ir.'}, {'ForeName': 'Faramarz', 'Initials': 'F', 'LastName': 'Ismail-Beigi', 'Affiliation': 'Department of Medicine, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH, 44106, USA.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Zamani', 'Affiliation': 'Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Masoudreza', 'Initials': 'M', 'LastName': 'Sohrabi', 'Affiliation': 'Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Reza Babaei', 'Affiliation': 'Department of Interventional Radiology, Firouzgar Hospital, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mohammad E', 'Initials': 'ME', 'LastName': 'Khamseh', 'Affiliation': 'Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}]",Advances in therapy,['10.1007/s12325-020-01498-5']
1825,32971053,Community-based antiretroviral therapy versus standard clinic-based services for HIV in South Africa and Uganda (DO ART): a randomised trial.,"BACKGROUND


Community-based delivery of antiretroviral therapy (ART) for HIV, including ART initiation, clinical and laboratory monitoring, and refills, could reduce barriers to treatment and improve viral suppression, reducing the gap in access to care for individuals who have detectable HIV viral load, including men who are less likely than women to be virally suppressed. We aimed to test the effect of community-based ART delivery on viral suppression among people living with HIV not on ART.
METHODS


We did a household-randomised, unblinded trial (DO ART) of delivery of ART in the community compared with the clinic in rural and peri-urban settings in KwaZulu-Natal, South Africa and the Sheema District, Uganda. After community-based HIV testing, people living with HIV were randomly assigned (1:1:1) with mobile phone software to community-based ART initiation with quarterly monitoring and ART refills through mobile vans; ART initiation at the clinic followed by mobile van monitoring and refills (hybrid approach); or standard clinic ART initiation and refills. The primary outcome was HIV viral suppression at 12 months. If the difference in viral suppression was not superior between study groups, an a-priori test for non-inferiority was done to test for a relative risk (RR) of more than 0·95. The cost per person virally suppressed was a co-primary outcome of the study. This study is registered with ClinicalTrials.gov, NCT02929992.
FINDINGS


Between May 26, 2016, and March 28, 2019, of 2479 assessed for eligibility, 1315 people living with HIV and not on ART with detectable viral load at baseline were randomly assigned; 666 (51%) were men. Retention at the month 12 visit was 95% (n=1253). At 12 months, community-based ART increased viral suppression compared with the clinic group (306 [74%] vs 269 [63%], RR 1·18, 95% CI 1·07-1·29; p superiority =0·0005) and the hybrid approach was non-inferior (282 [68%] vs 269 [63%], RR 1·08, 0·98-1·19; p non-inferiority =0·0049). Community-based ART increased viral suppression among men (73%, RR 1·34, 95% CI 1·16-1·55; p superiority <0·0001) as did the hybrid approach (66%, RR 1·19, 1·02-1·40; p superiority =0·026), compared with clinic-based ART (54%). Viral suppression was similar for men (n=156 [73%]) and women (n=150 [75%]) in the community-based ART group. With efficient scale-up, community-based ART could cost US$275-452 per person reaching viral suppression. Community-based ART was considered safe, with few adverse events.
INTERPRETATION


In high and medium HIV prevalence settings in South Africa and Uganda, community-based delivery of ART significantly increased viral suppression compared with clinic-based ART, particularly among men, eliminating disparities in viral suppression by gender. Community-based ART should be implemented and evaluated in different contexts for people with detectable viral load.
FUNDING


The Bill & Melinda Gates Foundation; the University of Washington and Fred Hutch Center for AIDS Research; the Wellcome Trust; the University of Washington Royalty Research Fund; and the University of Washington King K Holmes Endowed Professorship in STDs and AIDS.",2020,"In high and medium HIV prevalence settings in South Africa and Uganda, community-based delivery of ART significantly increased viral suppression compared with clinic-based ART, particularly among men, eliminating disparities in viral suppression by gender.","['After community-based HIV testing, people living with HIV', 'Between May 26, 2016, and March 28, 2019, of 2479 assessed for eligibility, 1315 people living with HIV and not on ART with detectable viral load at baseline were randomly assigned; 666 (51%) were men', 'people living with HIV not on ART', 'men (n=156 [73%]) and women (n=150 [75%]) in the community-based ART group', 'rural and peri-urban settings in KwaZulu-Natal, South Africa and the Sheema District, Uganda', 'for HIV in South Africa and Uganda (DO ART', 'people with detectable viral load']","['mobile phone software to community-based ART initiation with quarterly monitoring and ART refills through mobile vans; ART initiation at the clinic followed by mobile van monitoring and refills (hybrid approach); or standard clinic ART initiation and refills', 'antiretroviral therapy (ART', 'community-based ART delivery', 'Community-based antiretroviral therapy versus standard clinic-based services']","['Viral suppression', 'HIV viral suppression', 'viral suppression']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0557775', 'cui_str': 'Van'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",,0.528336,"In high and medium HIV prevalence settings in South Africa and Uganda, community-based delivery of ART significantly increased viral suppression compared with clinic-based ART, particularly among men, eliminating disparities in viral suppression by gender.","[{'ForeName': 'Ruanne V', 'Initials': 'RV', 'LastName': 'Barnabas', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA; Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA; Department of Epidemiology, University of Washington, Seattle, WA, USA; Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. Electronic address: rbarnaba@uw.edu.'}, {'ForeName': 'Adam A', 'Initials': 'AA', 'LastName': 'Szpiro', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'van Rooyen', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa; MRC/Wits Developmental Pathways for Health Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Asiimwe', 'Affiliation': 'Integrated Community-Based Initiatives, Kabwohe, Uganda.'}, {'ForeName': 'Deenan', 'Initials': 'D', 'LastName': 'Pillay', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Norma C', 'Initials': 'NC', 'LastName': 'Ware', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Torin T', 'Initials': 'TT', 'LastName': 'Schaafsma', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Meighan L', 'Initials': 'ML', 'LastName': 'Krows', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'van Heerden', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa; MRC/Wits Developmental Pathways for Health Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Joseph', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shahmanesh', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Monique A', 'Initials': 'MA', 'LastName': 'Wyatt', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kombi', 'Initials': 'K', 'LastName': 'Sausi', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Bosco', 'Initials': 'B', 'LastName': 'Turyamureeba', 'Affiliation': 'Integrated Community-Based Initiatives, Kabwohe, Uganda.'}, {'ForeName': 'Nsika', 'Initials': 'N', 'LastName': 'Sithole', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Morrison', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Adrienne E', 'Initials': 'AE', 'LastName': 'Shapiro', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA; Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'D Allen', 'Initials': 'DA', 'LastName': 'Roberts', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Thomas', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Koole', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bershteyn', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ehrenkranz', 'Affiliation': 'The Bill & Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA; Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA; Department of Epidemiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Celum', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA; Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA; Department of Epidemiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(20)30313-2']
1826,32971156,The effect of beta-glucan supplementation on glycemic control and variability in adolescents with type 1 diabetes mellitus.,"AIMS


This study aimed to investigate whether supplemental soluble fiber, oat β-glucan, has any effect on glycemic control and variability of adolescents with type 1 diabetes mellitus.
METHODS


This study was conducted in 30 adolescents with type 1 diabetes mellitus and it consisted of three phases lasting one week. At Phase I, all subjects followed a standard diet program. For Phase II and Phase III, the subjects continued their standard diet program and added natural oat flakes containing 3 g/day and 6 g/day β-glucan, respectively. Glucose levels were monitored by continuous glucose monitoring (CGM). The maximal, minimal, mean and daytime and night blood glucose levels, percentages of glucose values in a target range and below and above a target values were calculated for each of the phases. Premeal, postmeal, peak blood glucose values and peak times of meals were evaluated for each of the phases. Glycemic variability was measured via SD, CV, MAGE, IQR, MODD, LBGI, HBGI, and CONGA parameters.
RESULTS


The maximal, mean and daytime and night blood glucose levels were the lowest at Phase III (p < 0.05). Minimal blood glucose levels were the highest at Phase III (p < 0.05). Phase I, II, and III showed similar durations elapsed for Level 2 and Level 1 hypoglycemia, euglycemia, Level 1 and Level 2 hyperglycemia (p > 0.05). Premeal and postmeal blood glucose levels were lowest at Phase III for breakfast, lunch, and overall (p < 0.05). The lowest peak blood glucose levels were detected at Phase III for breakfast, lunch, dinner and overall (p < 0.05). Phase III also showed delayed peaks for all time-points (p < 0.05 for each) compared to other phases. Phase III had significantly lower levels of SD, CV, LBGI, and CONGA levels than those in either Phase I or Phase II (p < 0.05 for each).
CONCLUSION


6 g/day oat β-glucan have favorable outcomes in glycemic control and variability in adolescents with type 1 diabetes mellitus.",2020,"The maximal, mean and daytime and night blood glucose levels were the lowest at Phase III (p<0.05).","['Adolescents with Type 1 Diabetes Mellitus', '30 adolescents with type 1 diabetes mellitus and it consisted of three phases lasting one week', 'adolescents with type 1 diabetes mellitus']","['Beta-Glucan Supplementation', 'supplemental soluble fiber, oat β-glucan']","['lowest peak blood glucose levels', 'levels of SD, CV, LBGI, and CONGA levels', 'Premeal, postmeal, peak blood glucose values and peak times of meals', 'maximal, minimal, mean and daytime and night blood glucose levels, percentages of glucose values', 'Glycemic Control and Variability', 'Glucose levels', 'maximal, mean and daytime and night blood glucose levels', 'Minimal blood glucose levels', 'Glycemic variability was measured via SD, CV, MAGE, IQR, MODD, LBGI, HBGI, and CONGA parameters', 'glycemic control and variability', 'Premeal and postmeal blood glucose levels', 'Level 2 and Level 1 hypoglycemia, euglycemia, Level 1 and Level 2 hyperglycemia (p>0.05']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C1134651', 'cui_str': 'Beta glucan'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3661727', 'cui_str': 'Soluble fiber'}, {'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C0017692', 'cui_str': 'Glucan (BO)'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",30.0,0.00984219,"The maximal, mean and daytime and night blood glucose levels were the lowest at Phase III (p<0.05).","[{'ForeName': 'Rukiye', 'Initials': 'R', 'LastName': 'Bozbulut', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, Turkey. Electronic address: dyt_rukiye@hotmail.com.'}, {'ForeName': 'Nevin', 'Initials': 'N', 'LastName': 'Şanlıer', 'Affiliation': 'Ankara Medipol University, Faculty of Health Sciences, Department of Nutrition and Dietetics, Ankara, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Döğer', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, Turkey.'}, {'ForeName': 'Aysun', 'Initials': 'A', 'LastName': 'Bideci', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, Turkey.'}, {'ForeName': 'Orhun', 'Initials': 'O', 'LastName': 'Çamurdan', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, Turkey.'}, {'ForeName': 'Peyami', 'Initials': 'P', 'LastName': 'Cinaz', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, Turkey.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108464']
1827,32971161,"Treatment of women's sexual dysfunction using Apium graveolens L. Fruit (celery seed): A double-blind, randomized, placebo-controlled clinical trial.","ETHNOPHARMACOLOGICAL RELEVANCE


Traditional manuscripts refer to plants such as Apium graveolens L. Fruit (celery seed), which could be used to improve sexual function among women. Since that time, local herbal shops in Iran continue to provide this herb as a natural aphrodisiac product.
AIM OF THE STUDY


This study aimed to evaluate the efficacy and safety of celery seed for the treatment of female sexual dysfunction.
METHODS AND MATERIALS


In this parallel, randomized, double-blinded clinical trial, 80 women were assigned to receive either 500 mg of celery seed or placebo 3 times a day for a period of 6 weeks (n = 40 per group). The female sexual function index (FSFI) questionnaire was used to evaluate women's sexual function before and after treatment.
RESULTS


At the end of the sixth week, an improvement in the total FSFI score was significantly greater in celery seed-treated women than those receiving the placebo (P < 0.001). Increased total FSFI score is mainly contributed by improvement in the sexual desire (p < 0.001), arousal (p < 0.001), lubrication (p < 0.001), and pain (p = 0.033) domains at the endpoint of study. No serious side effects were noticed in both groups during the study period.
CONCLUSION


It seems that celery seed improved sexual function in women and could be used as a safe, well-tolerated, and effective herbal medicine in women with sexual dysfunction.",2020,"At the end of the sixth week, an improvement in the total FSFI score was significantly greater in celery seed-treated women than those receiving the placebo (P<0.001).","['female sexual dysfunction', ""women's sexual dysfunction using Apium graveolens L. Fruit (celery seed"", 'women with sexual dysfunction', 'Traditional manuscripts refer to plants such as Apium graveolens L. Fruit (celery seed', '80 women']","['placebo', '500 mg of celery seed or placebo', 'Placebo']","['serious side effects', 'total FSFI score', 'efficacy and safety', 'arousal', 'female sexual function index (FSFI) questionnaire', 'sexual function', 'sexual desire', 'lubrication', 'pain']","[{'cui': 'C1112442', 'cui_str': 'Female sexual dysfunction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0996918', 'cui_str': 'Apium'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0453248', 'cui_str': 'Celery seed'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0453248', 'cui_str': 'Celery seed'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",80.0,0.412374,"At the end of the sixth week, an improvement in the total FSFI score was significantly greater in celery seed-treated women than those receiving the placebo (P<0.001).","[{'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran; Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Rahnavard', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ayda', 'Initials': 'A', 'LastName': 'Hosseinkhani', 'Affiliation': 'Research Center of Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Azima', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mehrab', 'Initials': 'M', 'LastName': 'Sayadi', 'Affiliation': 'Department of Biostatistics, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Faraji', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Massoumeh', 'Initials': 'M', 'LastName': 'Emamghoreishi', 'Affiliation': 'Department of Pharmacology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Hessami', 'Affiliation': 'School of Pharmacy, International Branch, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: anna_hessami@yahoo.com.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Foroughinia', 'Affiliation': 'Box Hill Hospital, FRANZCOG, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Maasumeh Kaviani', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Roozmeh', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: nasadi2012@yahoo.ca.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113400']
1828,32971163,Episiotomy wound healing by Commiphora myrrha (Nees) Engl. and Boswellia carteri Birdw. in primiparous women: A randomized controlled trial.,"ETHNOPHARMACOLOGICAL RELEVANCE


Traditional Persian medicine manuscripts refer to plants such as Commiphora myrrha (Nees) Engl. (myrrh) and Boswellia carteri Birdw. (frankincense), which could be used to improve wound healing process. Since that time, local midwives in Iran continue to provide these herbs to precipitate episiotomy wound healing.
AIM OF THE STUDY


To investigate the efficacy and safety of myrrh- and frankincense-based sitz-baths on episiotomy wound healing in primiparous women.
MATERIALS AND METHODS


This randomized controlled trial was conducted on 90 primiparous women with singleton pregnancies after normal vaginal delivery at Hafez hospital affiliated to Shiraz University of Medical Sciences from July to October 2019. Study participants were randomly allocated in three groups (2 intervention groups and 1 control group). Women in intervention groups were assigned to receive either 10-min sitz-bath of myrrh extract or frankincense extract twice a day for 1 week. While the women in control group received the betadine sitz-bath for the same period of time. The main outcome was the episiotomy wound healing, which was measured using the REEDA scale before intervention, on 2nd and 7th postpartum days.
RESULTS


An improvement in the episiotomy wound healing was significantly greater in patients receiving myrrh than those receiving the frankincense or betadine on 2nd (p = 0.003 and p < 0.001) and 7th (p = 0.043 and p = 0.015) postpartum days. However, the total REEDA score was not statistically different between the frankincense and betadine groups on 2nd and 7th postpartum days (p > 0.05).
CONCLUSION


The present results suggest that myrrh was more efficient than frankincense and betadine in healing of the episiotomy wound and could be recommended as a safe natural therapy.",2020,An improvement in the episiotomy wound healing was significantly greater in patients receiving myrrh than those receiving the frankincense or betadine on 2 nd  (p=0.003 and p<0.001) and 7 th  (p=0.043 and p=0.015) postpartum days.,"['primiparous women', 'Traditional Persian medicine manuscripts refer to plants such as Commiphora myrrha (Nees) Engl', '90 primiparous women with singleton pregnancies after normal vaginal delivery at Hafez hospital affiliated to Shiraz University of Medical Sciences from July to October 2019']","['betadine sitz-bath', 'myrrh- and frankincense-based sitz-baths', 'betadine', '10-minute sitz-bath of myrrh extract or frankincense extract']","['total REEDA score', 'efficacy and safety', 'Episiotomy wound healing', 'episiotomy wound healing, which was measured using the REEDA scale', 'episiotomy wound healing']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C1536360', 'cui_str': 'Commiphora molmol'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0699524', 'cui_str': 'Betadine'}, {'cui': 'C0207011', 'cui_str': 'Myrrh extract'}, {'cui': 'C0949991', 'cui_str': 'Boswellia sacra'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C3256678', 'cui_str': 'Frankincense extract'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",90.0,0.0403952,An improvement in the episiotomy wound healing was significantly greater in patients receiving myrrh than those receiving the frankincense or betadine on 2 nd  (p=0.003 and p<0.001) and 7 th  (p=0.043 and p=0.015) postpartum days.,"[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Faraji', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: farajiaz@sums.ac.ir.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Aghdaki', 'Affiliation': 'Obstetrics and Gynecology Department, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: maryam.aghdaki@yahoo.com.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: hessamikamran@gmail.com.'}, {'ForeName': 'Ayda', 'Initials': 'A', 'LastName': 'Hosseinkhani', 'Affiliation': 'Thoracic and Vascular Surgery Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: hoseinkhan@sums.ac.ir.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Roozmeh', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: dr.roozmeh1995@yahoo.com.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: nasadi2012@yahoo.ca.'}, {'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: vafaeih@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kasraeian', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: kasraeemm@yahoo.com.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'School of Nursing &Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: royakianbagheri64@gmail.com.'}, {'ForeName': 'Khadije', 'Initials': 'K', 'LastName': 'Bazrafshan', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: bazrafshan.kh@gmail.com.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Foroughinia', 'Affiliation': 'Box Hill Hospital, FRANZCOG, Eastern Health, Victoria, Australia. Electronic address: Foroughinialeila@yahoo.com.au.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113396']
1829,32973176,Phase I clinical trial repurposing all-trans retinoic acid as a stromal targeting agent for pancreatic cancer.,"Pre-clinical models have shown that targeting pancreatic stellate cells with all-trans-retinoic-acid (ATRA) reprograms pancreatic stroma to suppress pancreatic ductal adenocarcinoma (PDAC) growth. Here, in a phase Ib, dose escalation and expansion, trial for patients with advanced, unresectable PDAC (n = 27), ATRA is re-purposed as a stromal-targeting agent in combination with gemcitabine-nab-paclitaxel chemotherapy using a two-step adaptive continual re-assessment method trial design. The maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D, primary outcome) is the FDA/EMEA approved dose of gemcitabine-nab-paclitaxel along-with ATRA (45 mg/m 2  orally, days 1-15/cycle). Dose limiting toxicity (DLT) is grade 4 thrombocytopenia (n = 2). Secondary outcomes show no detriment to ATRA pharmacokinetics.. Median overall survival for RP2D treated evaluable population, is 11.7 months (95%CI 8.6-15.7 m, n = 15, locally advanced (2) and metastatic (13)). Exploratory pharmacodynamics studies including changes in diffusion-weighted (DW)-MRI measured apparent diffusion coefficient after one cycle, and, modulation of cycle-specific serum pentraxin 3 levels over various cycles indicate stromal modulation. Baseline stromal-specific retinoid transport protein (FABP5, CRABP2) expression may be predicitve of response. Re-purposing ATRA as a stromal-targeting agent with gemcitabine-nab-paclitaxel is safe and tolerable. This combination will be evaluated in a phase II randomized controlled trial for locally advanced PDAC. Clinical trial numbers: EudraCT: 2015-002662-23; NCT03307148. Trial acronym: STARPAC.",2020,"Baseline stromal-specific retinoid transport protein (FABP5, CRABP2) expression may be predicitve of response. Re-purposing ATRA as a stromal-targeting agent with gemcitabine-nab-paclitaxel is safe and tolerable.","['pancreatic cancer', 'patients with advanced, unresectable PDAC (n\u2009=\u200927), ATRA is re-purposed as a stromal-targeting agent in combination with']","['ATRA', 'gemcitabine-nab-paclitaxel chemotherapy', 'trans retinoic acid', 'gemcitabine-nab-paclitaxel']","['ATRA pharmacokinetics', 'Median overall survival']","[{'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.113681,"Baseline stromal-specific retinoid transport protein (FABP5, CRABP2) expression may be predicitve of response. Re-purposing ATRA as a stromal-targeting agent with gemcitabine-nab-paclitaxel is safe and tolerable.","[{'ForeName': 'Hemant M', 'Initials': 'HM', 'LastName': 'Kocher', 'Affiliation': 'Centre for Tumour Biology, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University London, London, EC1M 6BQ, UK. h.kocher@qmul.ac.uk.'}, {'ForeName': 'Bristi', 'Initials': 'B', 'LastName': 'Basu', 'Affiliation': ""Department of Oncology, University of Cambridge and Cambridge University Hospitals NHS Foundation Trust-Addenbrooke's Hospital, Cambridge, CB2 0QQ, UK.""}, {'ForeName': 'Fieke E M', 'Initials': 'FEM', 'LastName': 'Froeling', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London-Hammersmith Hospital, London, W12 0HS, UK.'}, {'ForeName': 'Debashis', 'Initials': 'D', 'LastName': 'Sarker', 'Affiliation': ""School of Cancer and Pharmaceutical Sciences, King's College London, Guy's Hospital Campus, London, SE1 9RT, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Slater', 'Affiliation': 'Barts and the London HPB Centre, The Royal London Hospital, Barts Health NHS Trust, Whitechapel, London, E1 1FR, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Carlin', 'Affiliation': 'Division of Radiotherapy and Imaging, The Institute of Cancer Research, London, SW7 3RP, UK.'}, {'ForeName': 'Nandita M', 'Initials': 'NM', 'LastName': 'deSouza', 'Affiliation': 'Division of Radiotherapy and Imaging, The Institute of Cancer Research, London, SW7 3RP, UK.'}, {'ForeName': 'Katja N', 'Initials': 'KN', 'LastName': 'De Paepe', 'Affiliation': 'Division of Radiotherapy and Imaging, The Institute of Cancer Research, London, SW7 3RP, UK.'}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Goulart', 'Affiliation': 'Centre for Tumour Biology, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': 'Centre for Tumour Biology, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Imrali', 'Affiliation': 'Barts Pancreas Tissue Bank, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Roberts', 'Affiliation': 'Barts Pancreas Tissue Bank, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pawula', 'Affiliation': 'PK/Bioanalytics Core Facility, Cancer Research UK Cambridge Institute, University of Cambridge, Li Ka Shing Centre, Robinson Way, Cambridge, CB2 0RE, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Houghton', 'Affiliation': 'PK/Bioanalytics Core Facility, Cancer Research UK Cambridge Institute, University of Cambridge, Li Ka Shing Centre, Robinson Way, Cambridge, CB2 0RE, UK.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Lawrence', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Yathushan', 'Initials': 'Y', 'LastName': 'Yogeswaran', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Mousa', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Carike', 'Initials': 'C', 'LastName': 'Coetzee', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sasieni', 'Affiliation': 'Cancer Prevention Trials Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Prendergast', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Propper', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University of London, London, EC1M 6BQ, UK.'}]",Nature communications,['10.1038/s41467-020-18636-w']
1830,32977025,Seizure threshold manipulation in electroconvulsive therapy via repetitive transcranial magnetic stimulation. A novel way of augmentation?,"INTRODUCTION


A high seizure threshold (ST) is an impeding factor in certain patients, potentially preventing a successful electroconvulsive therapy (ECT) treatment. Several pharmacological and non-pharmacological methods have been put forward to augment ECT in such patients, however, to this date, only a handful of case reports existed about the potential role of repetitive transcranial magnetic stimulation (rTMS), as an augmentation method.
OBJECTIVES


and Methods: In this randomized, double-blinded, sham controlled study, we set out to test the hypothesis of whether the application of high frequency transcranial magnetic stimulation (HF rTMS) lowers the seizure threshold for electroconvulsive therapy and whether it has an effect on other aspects of ECT treatment, such as seizure duration (SD), efficacy and safety.
RESULTS


46 patients treated for a major depressive episode, indicated for ECT, were recruited to this study. A significantly lower seizure threshold was observed in the experimental group during ECT titration, on average a decrease by 34.55%, from 34.23 mC to 22.4 mC, p < 0.001 (Wilcox test). We had not observed a significant effect of TMS stimulation before ECT on seizure duration or clinical outcome. Another potentially important observation of this study is that 4 patients in the experimental group developed transient symptoms of hypomania/mania, all of which were stabilized after the combined stimulation protocol was halted spontaneously within a week, without the need to administer mood stabilizers.
CONCLUSION


It is likely that HF rTMS stimulation prior to ECT is a novel and simple way of reducing the ST, which is useful in certain groups of patients undergoing this important treatment modality.",2020,"A significantly lower seizure threshold was observed in the experimental group during ECT titration, on average a decrease by 34.55%, from 34.23mC to 22.4mC, p < 0.001 (Wilcox test).","['46 patients treated for a major depressive episode, indicated for ECT']","['electroconvulsive therapy via repetitive transcranial magnetic stimulation', 'repetitive transcranial magnetic stimulation (rTMS', 'high frequency transcranial magnetic stimulation (HF rTMS']","['seizure duration (SD), efficacy and safety', 'seizure threshold', 'transient symptoms of hypomania/mania', 'TMS stimulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0241934', 'cui_str': 'Hypomania'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",46.0,0.0778151,"A significantly lower seizure threshold was observed in the experimental group during ECT titration, on average a decrease by 34.55%, from 34.23mC to 22.4mC, p < 0.001 (Wilcox test).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Buday', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic. Electronic address: jozef.buday@vfn.cz.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Albrecht', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Podgorná', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mareš', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Le', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Čapek', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mahrík', 'Affiliation': 'Institute of Clinical and Experimental Medicine, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pol', 'Affiliation': 'Institute of Clinical and Experimental Medicine, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Raboch', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Anders', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}]",Brain stimulation,['10.1016/j.brs.2020.09.008']
1831,32978194,Rehabilitation nursing for motor functional recovery of acute ischaemic stroke: study protocol for a randomised controlled trial.,"INTRODUCTION


Stroke is the second-leading cause of death and disability in the world, and patients with stroke often suffer from functional impairments and need rehabilitation. Notably, there is much evidence that rehabilitation can lead to better mortality and morbidity outcomes. The evidence for the effectiveness of rehabilitation nursing, however, is limited. Thus, this study seeks to explore whether rehabilitation nursing is not inferior to usual rehabilitation for motor functional recovery in patients with acute ischaemic stroke.
METHODS AND ANALYSIS


We will conduct an assessor-blinded parallel randomised controlled trial of patients who meet the inclusion criteria after stratification by weighted corticospinal tract lesion load. The experimental group will receive rehabilitation nursing by trained and qualified nurses (seven consecutive days, two sessions per day, 30 min each session). The control group will receive usual rehabilitation provided by therapists (seven consecutive days, two sessions per day, 30 min each session). The primary outcome measures are the Motor Assessment Scale, the Fugl-Meyer Assessment and the Action Research Arm Test. The secondary outcome measures are the modified Rankin Scale, the modified Barthel Index and the National Institute of Health Stroke Scale. Primary and secondary outcome assessment will be performed before and after the intervention, and secondary outcome be assessed at 4 and 12 weeks follow-up. We will recruit 224 patients within a period of 12-18 months from a hospital in southeastern China.
ETHICS AND DISSEMINATION


The study was approved by the Human Research Ethics Committee from the corresponding author's hospital (approval Number is Ethical Review Study No. 2018 - 112). Peer-reviewed journals and presentations at national and international conferences will be used to disseminate the results.
TRIAL REGISTRATION NUMBER


NCT03702452.",2020,"The secondary outcome measures are the modified Rankin Scale, the modified Barthel Index and the National Institute of Health Stroke Scale.","['patients with stroke often suffer from functional impairments and need rehabilitation', 'patients with acute ischaemic stroke', 'patients who meet the inclusion criteria after stratification by weighted corticospinal tract lesion load', '224 patients within a period of 12-18\u2009months from a hospital in southeastern China', 'acute ischaemic stroke']","['usual rehabilitation provided by therapists', 'Rehabilitation nursing', 'rehabilitation nursing by trained and qualified nurses']","['Motor Assessment Scale, the Fugl-Meyer Assessment and the Action Research Arm Test', 'modified Rankin Scale, the modified Barthel Index and the National Institute of Health Stroke Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0936236', 'cui_str': 'Corticospinal Tracts'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0376427', 'cui_str': 'Nursing, Rehabilitation'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0451321', 'cui_str': 'Motor assessment scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",224.0,0.142712,"The secondary outcome measures are the modified Rankin Scale, the modified Barthel Index and the National Institute of Health Stroke Scale.","[{'ForeName': 'Jianmiao', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Nursing Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Neurology Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Nursing Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Nursing Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Jingfen', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Nursing Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China zrjzkhl@zju.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2020-037391']
1832,32978200,"Protocol, rationale and design of DAbigatran for Stroke PreVention In Atrial Fibrillation in MoDerate or Severe Mitral Stenosis (DAVID-MS): a randomised, open-label study.","INTRODUCTION


Current international guidelines recommend non-vitamin K oral anticoagulants (NOACs) for stroke prevention among patients with non-valvular atrial fibrillation (AF) at significant ischaemic stroke risk given the superior safety and comparable efficacy of NOACs over warfarin. Nonetheless, the safety and effectiveness of NOACs have not been evaluated in patients with AF with underlying moderate or severe mitral stenosis (MS), hence the recommended stroke prevention strategy remains warfarin therapy.
METHOD AND ANALYSIS


MS remains disproportionately prevalent in Asian countries compared with the developed countries. This prospective, randomised, open-label trial with blinded endpoint adjudication aims to evaluate the safety and efficacy of dabigatran for stroke prevention in AF patients with moderate or severe MS. Patients with AF aged ≥18 years with moderate or severe MS not planned for valvular intervention in the coming 12 months will be randomised in a 1:1 ratio to receive dabigatran 110 mg or 150 mg two times per day or warfarin with international normalised ratio 2-3 in an open-label design. Patients with estimated creatinine clearance <30 mL/min, or with a concomitant indication for antiplatelet therapy will be excluded. The primary outcome is a composite of stroke and systemic embolism. Secondary outcomes are ischaemic stroke, systemic embolism, haemorrhagic stroke, intracranial haemorrhage, major bleeding and death. The estimated required sample size is approximately 686 participants.
ETHICS AND DISSEMINATION


The study protocol has been approved by the Institutional Review Board of the University of Hong Kong and Hong Kong West Cluster, Hospital Authority, Hong Kong for Fung Yiu King Hospital, Grantham Hospital, Queen Mary Hospital and Tung Wah Hospital in Hong Kong. Results will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT04045093); pre-results.",2020,"Secondary outcomes are ischaemic stroke, systemic embolism, haemorrhagic stroke, intracranial haemorrhage, major bleeding and death.","['686 participants', 'patients with AF with underlying moderate or severe mitral stenosis (MS', 'patients with non-valvular atrial fibrillation (AF', 'AF patients with moderate or severe MS', 'Patients with estimated creatinine clearance <30\u2009mL/min, or with a concomitant indication for antiplatelet therapy will be excluded', 'MoDerate or Severe Mitral Stenosis (DAVID-MS', 'Patients with AF aged ≥18 years with moderate or severe MS not planned for valvular intervention in the coming 12 months']","['vitamin K oral anticoagulants (NOACs', 'DAbigatran', 'dabigatran 110\u2009mg or 150\u2009mg two times per day or warfarin with international normalised ratio 2-3 in an open-label design', 'dabigatran']","['ischaemic stroke, systemic embolism, haemorrhagic stroke, intracranial haemorrhage, major bleeding and death', 'safety and efficacy', 'composite of stroke and systemic embolism']","[{'cui': 'C5191070', 'cui_str': '686'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026269', 'cui_str': 'Mitral valve stenosis'}, {'cui': 'C1273051', 'cui_str': 'Estimated creatinine clearance'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.205221,"Secondary outcomes are ischaemic stroke, systemic embolism, haemorrhagic stroke, intracranial haemorrhage, major bleeding and death.","[{'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Esther W', 'Initials': 'EW', 'LastName': 'Chan', 'Affiliation': 'Department of Pharmacology and Pharmacy, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Jo Jo', 'Initials': 'JJ', 'LastName': 'Hai', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Chun Ka', 'Initials': 'CK', 'LastName': 'Wong', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Yuk Ming', 'Initials': 'YM', 'LastName': 'Lau', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Duo', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Cheung Chi', 'Initials': 'CC', 'LastName': 'Lam', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Chor Cheung Frankie', 'Initials': 'CCF', 'LastName': 'Tam', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Yiu Tung Anthony', 'Initials': 'YTA', 'LastName': 'Wong', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'See Yue Arthur', 'Initials': 'SYA', 'LastName': 'Yung', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Ki Wan Kelvin', 'Initials': 'KWK', 'LastName': 'Chan', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Yingqing', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Cardiology Division, Guangdong Cardiovascular Institute, Guangzhou, Guangdong, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Tan', 'Affiliation': 'Cardiology Division, Guangdong Cardiovascular Institute, Guangzhou, Guangdong, China.'}, {'ForeName': 'Ji-Yan', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Cardiology Division, Guangdong Cardiovascular Institute, Guangzhou, Guangdong, China.'}, {'ForeName': 'Chi Yui', 'Initials': 'CY', 'LastName': 'Yung', 'Affiliation': 'Cardiology Division, Department of Medicine and Geriatrics, Ruttonjee and Tang Siu Kin Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Kwok Lun', 'Initials': 'KL', 'LastName': 'Lee', 'Affiliation': 'Cardiology Division, Department of Medicine and Geriatrics, Ruttonjee and Tang Siu Kin Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Chun Wai', 'Initials': 'CW', 'LastName': 'Choi', 'Affiliation': 'Cardiology Division, Department of Medicine and Geriatrics, Tuen Mun Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Ho', 'Initials': 'H', 'LastName': 'Lam', 'Affiliation': 'Cardiology Division, Department of Medicine and Geriatrics, Tuen Mun Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ng', 'Affiliation': 'Cardiac Medical Unit, Grantham Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Fan', 'Affiliation': 'Cardiac Medical Unit, Grantham Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Man Hong', 'Initials': 'MH', 'LastName': 'Jim', 'Affiliation': 'Cardiac Medical Unit, Grantham Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Kai Hang', 'Initials': 'KH', 'LastName': 'Yiu', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Bryan P', 'Initials': 'BP', 'LastName': 'Yan', 'Affiliation': 'Cardiology Division, Department of Medicine & Therapeutics, Chinese University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Chung Wah', 'Initials': 'CW', 'LastName': 'Siu', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China cwdsiu@hku.hk.'}]",BMJ open,['10.1136/bmjopen-2020-038194']
1833,32978204,Effects of a foot-ankle strengthening programme on clinical aspects and gait biomechanics in people with knee osteoarthritis: protocol for a randomised controlled trial.,"INTRODUCTION


Studies have indicated that hip and knee muscle strengthening are effective in reducing pain, improving self-reported function and increasing lower limb strength, without, however, decreasing knee joint overload during gait in patients with knee osteoarthritis (KOA). Recent research has shown that strengthening the foot-ankle muscles improved function in diabetic patients and reduced patellofemoral pain. The aim of this paper is to investigate whether an 8-week therapeutic foot-ankle exercise programme improves pain, functionality, foot strength, foot kinematics and knee joint overload during gait, and decreases medication intake in individuals with KOA.
METHODS AND ANALYSIS


This two-arm, prospectively registered, randomised controlled trial with blinded assessors will involve 88 patients with medial tibiofemoral osteoarthritis. Subjects will be randomly allocated to a control group that will receive no specific foot intervention and will follow treatment recommended by the medical team; or an intervention group that will undergo an 8-week physiotherapist-supervised strengthening programme for extrinsic and intrinsic foot muscles, three times a week. The primary outcome will be the pain domain of the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC). The secondary outcomes include WOMAC stiffness and function domains, total WOMAC score, physical function, foot muscle isometric strength, foot kinematics and knee kinetics during gait, and medication intake. Data will be analysed on intention-to-treat principles and a per protocol basis.
ETHICS AND DISSEMINATION


Investigators and sponsors will communicate trial results to participants and healthcare professionals through scientific databases and social media. In addition, findings will be reported in peer-review publications, and at national and international conference presentations. Ethics approval: Ethics Committee of the Universidade Federal de São Carlos, São Carlos, SP, Brazil (N° 3.488.466).
TRIAL REGISTRATION NUMBER


NCT04154059.",2020,Recent research has shown that strengthening the foot-ankle muscles improved function in diabetic patients and reduced patellofemoral pain.,"['individuals with KOA', 'patients with knee osteoarthritis (KOA', 'diabetic patients', 'people with knee osteoarthritis', '88 patients with medial tibiofemoral osteoarthritis']","['therapeutic foot-ankle exercise programme', 'control group that will receive no specific foot intervention and will follow treatment recommended by the medical team; or an intervention group that will undergo an 8-week physiotherapist-supervised strengthening programme', 'foot-ankle strengthening programme']","['clinical aspects and gait biomechanics', 'patellofemoral pain', 'pain domain of the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC', 'WOMAC stiffness and function domains, total WOMAC score, physical function, foot muscle isometric strength, foot kinematics and knee kinetics during gait, and medication intake', 'pain, functionality, foot strength, foot kinematics and knee joint overload during gait']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0454369', 'cui_str': 'Ankle exercises'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0581753', 'cui_str': 'Muscle structure of foot'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}]",88.0,0.0910656,Recent research has shown that strengthening the foot-ankle muscles improved function in diabetic patients and reduced patellofemoral pain.,"[{'ForeName': 'Glauko', 'Initials': 'G', 'LastName': 'Dantas', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Isabel C N', 'Initials': 'ICN', 'LastName': 'Sacco', 'Affiliation': 'Department of Physical Therapy, Speech, and Occupational Therapy, USP, Sao Paulo, Brazil.'}, {'ForeName': 'Ana F', 'Initials': 'AF', 'LastName': 'Dos Santos', 'Affiliation': 'UNA University Center, Pouso Alegre, Brazil.'}, {'ForeName': 'Ricky', 'Initials': 'R', 'LastName': 'Watari', 'Affiliation': 'Department of Physical Therapy, Speech, and Occupational Therapy, USP, Sao Paulo, Brazil.'}, {'ForeName': 'Alessandra B', 'Initials': 'AB', 'LastName': 'Matias', 'Affiliation': 'Department of Physical Therapy, Speech, and Occupational Therapy, USP, Sao Paulo, Brazil.'}, {'ForeName': 'Paula R M S', 'Initials': 'PRMS', 'LastName': 'Serrao', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Henrique', 'Initials': 'H', 'LastName': 'Pott-Junior', 'Affiliation': 'Department of Medicine, Universidade Federal de São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Tania F', 'Initials': 'TF', 'LastName': 'Salvini', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos (UFSCar), São Carlos, São Paulo, Brazil tania@ufscar.br.'}]",BMJ open,['10.1136/bmjopen-2020-039279']
1834,32970837,Comparison of absorbable and permanent sutures for laparoscopic sacrocervicopexy: A randomized controlled trial.,"INTRODUCTION


Pelvic organ prolapse is a common cause of morbidity and decreased quality of life among women and is treatable by laparoscopic sacrocolpopexy. Recent data suggest that absorbable sutures are a feasible and appealing option for mesh attachment given a potential decreased risk of complications related to mesh erosion. The aim of the present study was to demonstrate the non-inferiority of absorbable sutures to permanent sutures for laparoscopic sacrocervicopexy.
MATERIAL AND METHODS


We performed a randomized, single-blinded, non-inferiority trial comparing late-absorbable sutures (group A) to non-absorbable sutures (group B) for anterior and posterior vaginal mesh fixation during laparoscopic sacrocervicopexy at a single center in Italy. The primary outcome was prolapse correction at 12 months after surgery, defined as the absence of a pelvic organ prolapse leading edge reaching or extending below the level of the hymen and the absence of bulge symptoms. Secondary outcomes included intraoperative parameters, postoperative characteristics, and long-term morbidity. Statistical analyses were performed using STATA version 16.
RESULTS


A total of 150 patients with pelvic organ prolapse were prospectively randomized 1:1 into two groups (A or B). Baseline characteristics and intraoperative parameters including blood loss, operation time, and intraoperative complications were comparable between groups. The success rate was 100% in both groups and no differences in prolapse correction were observed. The rates of de novo urinary incontinence and persistent urinary incontinence were also similar between groups. The rate of mesh erosion at 12 months was 0% in group A and 4% in group B (P = .24).
CONCLUSIONS


Late absorbable sutures are non-inferior to non-absorbable sutures for laparoscopic sacrocervicopexy in terms of procedural success. Moreover we did not see any differences in terms of operative parameters, or intraoperative and postoperative characteristics, although the study was not powered to these outcomes.",2020,Late absorbable sutures are non-inferior to non-absorbable sutures for laparoscopic sacrocervicopexy in terms of procedural success.,"['150 patients with pelvic organ prolapse', 'laparoscopic sacrocervicopexy']","['absorbable sutures to permanent sutures', 'Late absorbable sutures', 'absorbable sutures', 'late-absorbable sutures (group A) to non-absorbable sutures (group B) for anterior and posterior vaginal mesh fixation during laparoscopic sacrocervicopexy', 'absorbable and permanent sutures']","['blood loss, operation time, and intraoperative complications', 'absence of a pelvic organ prolapse leading edge reaching or extending below the level of the hymen and the absence of bulge symptoms', 'intraoperative parameters, postoperative characteristics, and long-term morbidity', 'success rate', 'rates of de novo urinary incontinence and persistent urinary incontinence', 'rate of mesh erosion', 'prolapse correction']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0461643', 'cui_str': 'Absorbable suture'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0461628', 'cui_str': 'Non-absorbable suture'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}]",150.0,0.375679,Late absorbable sutures are non-inferior to non-absorbable sutures for laparoscopic sacrocervicopexy in terms of procedural success.,"[{'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Tagliaferri', 'Affiliation': 'Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Policlinico Agostino Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Ruggieri', 'Affiliation': 'Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Policlinico Agostino Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Taccaliti', 'Affiliation': 'Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Policlinico Agostino Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Cosimo', 'Initials': 'C', 'LastName': 'Gentile', 'Affiliation': 'Department of Obstetrics and Gynecology, General Regional Hospital ""F. Miulli"", Acquaviva delle Fonti, Italy.'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Didonna', 'Affiliation': 'Department of Obstetrics and Gynecology, General Regional Hospital ""F. Miulli"", Acquaviva delle Fonti, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': ""D'asta"", 'Affiliation': 'Department of Obstetrics and Gynecology, General Regional Hospital ""F. Miulli"", Acquaviva delle Fonti, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Legge', 'Affiliation': 'Department of Obstetrics and Gynecology, General Regional Hospital ""F. Miulli"", Acquaviva delle Fonti, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Guida', 'Affiliation': 'Department of Obstetrics and Gynecology, General Regional Hospital ""F. Miulli"", Acquaviva delle Fonti, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Policlinico Agostino Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Guido', 'Affiliation': 'Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Policlinico Agostino Gemelli IRCCS, Rome, Italy.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13997']
1835,32971302,"Manual push technique, an alternative route of subcutaneous immunoglobulin administration in chronic inflammatory demyelinating polyradiculoneuropathy: A proof-of-concept study.","OBJECTIVE


Subcutaneous immunoglobulin (SCIg) administered through infusion pump has been reported as effective in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) patients. In this study we evaluate an alternative technique of SCIg administration, based on the delivery of lower volumes administered daily using manual push technique (MPT) in 10 CIDP patients.
METHODS


In this randomized, controlled, two-arm, crossover clinical trial, CIDP patients were randomly assigned 1:1 to receive SCIg either by MPT or pumps for 4 consecutive months with crossover to the other. The primary objective was to assess whether MPT had the same effectiveness as pumps. The secondary objectives were to assess whether MPT resulted in greater plasma IgG levels and improved quality of life (QoL).
RESULTS


Ten patients (mean age = 48.3) were enrolled. No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales). A positive mean variation of 5.4 % in plasma IgG levels in the group treated with MPT was observed at the end of MPT periods. Treatment interference, which is one of the dimensions of the Life Quality Index, showed a significant improvement in the MPT periods.
CONCLUSION


In CIDP patients, the MPT technique was as effective as pump infusion, allowed comparable, slightly increases plasma IgG levels, and also improved the QoL.",2020,"No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales).","['chronic inflammatory demyelinating polyradiculoneuropathy', 'Ten patients (mean age\u202f=\u202f48.3) were enrolled', '10 CIDP patients', 'CIDP patients', 'chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) patients']","['Subcutaneous immunoglobulin (SCIg', 'manual push technique (MPT', 'subcutaneous immunoglobulin administration', 'SCIg either by MPT', 'MPT']","['efficacy parameters (INCAT, MRC, R-ODS, and GS scales', 'plasma IgG levels', 'plasma IgG levels and improved quality of life (QoL']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0032587', 'cui_str': 'Polyradiculoneuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",10.0,0.0784501,"No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales).","[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Cocito', 'Affiliation': 'Divisione di Riabilitazione Neuromotoria, Istituti Clinici Scientifici Maugeri, Presidio Sanitario Major, Via Santa Giulia, 60, 10124, Torino, Italy. Electronic address: dariococito@yahoo.it.'}, {'ForeName': 'Erdita', 'Initials': 'E', 'LastName': 'Peci', 'Affiliation': 'Divisione di Riabilitazione Neuromotoria, Istituti Clinici Scientifici Maugeri, Presidio Sanitario Major, Via Santa Giulia, 60, 10124, Torino, Italy. Electronic address: erditapeci@gmail.com.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Rigaldo', 'Affiliation': 'Dipartimento di Neuroscienze - Università di Torino, A.O.U. Città della Salute e della Scienza di Torino, Corso Bramante, 88, 10126, Torino, Italy. Electronic address: simonarigaldo@yahoo.com.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Canavese', 'Affiliation': 'Dipartimento di Neuroscienze - Università di Torino, A.O.U. Città della Salute e della Scienza di Torino, Corso Bramante, 88, 10126, Torino, Italy. Electronic address: ccanavese@cittadellasalute.to.it.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Migliaretti', 'Affiliation': 'Dipartimento di Sanità Pubblica e Scienze Pediatriche - Università di Torino, Piazza Polonia, 94, 10126 Torino, Italy. Electronic address: giuseppe.migliaretti@unito.it.'}, {'ForeName': 'Federico M', 'Initials': 'FM', 'LastName': 'Cossa', 'Affiliation': 'Divisione di Riabilitazione Neuromotoria, Istituti Clinici Scientifici Maugeri, Presidio Sanitario Major, Via Santa Giulia, 60, 10124, Torino, Italy. Electronic address: federico.cossa@icsmaugeri.it.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106240']
1836,32971314,Quality of life after response to acute-phase cognitive therapy for recurrent depression.,"BACKGROUND


Adults with major depressive disorder (MDD) often experience reduced quality of life (QOL). Efficacious acute-phase treatments, including cognitive therapy (CT) or medication, decrease depressive symptoms and, to a lesser degree, increase QOL. We tested longer-term changes in QOL after response to acute-phase CT, including the potential effects of continuation treatment for depression and time-lagged relations between QOL and depressive symptoms.
METHODS


Responders to acute-phase CT (N = 290) completed QOL and depressive symptom assessments repeatedly for 32 post-acute months. Higher-risk responders were randomized to 8 months of continuation treatment (CT, fluoxetine, or pill placebo) and then entered a 24-month follow-up. Lower-risk responders were only assessed for 32 months.
RESULTS


On average, large gains in QOL made during acute-phase CT response were maintained for 32 months. Continuation CT or fluoxetine did not improve QOL relative to pill placebo. Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence. Higher QOL predicted subsequent reductions in depressive symptom severity, but depressive symptom severity did not predict subsequent changes in QOL.
LIMITATIONS


Generalization of results to other patient populations, treatments, and measures is uncertain. The clinical trial was not designed to test relations between QOL and depression. Replication is needed before clinical application of these results.
CONCLUSIONS


Gains in QOL made during response to acute-phase CT are relatively stable and may help protect against relapse/recurrence. Continuation CT or fluoxetine may not further improve QOL among acute-phase CT responders.",2020,"Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence.","['Responders to acute-phase CT', 'Adults with major depressive disorder (MDD', 'recurrent depression', 'Higher-risk responders']","['cognitive therapy (CT', 'continuation treatment (CT, fluoxetine, or pill placebo', 'fluoxetine']","['QOL relative', 'depressive symptom severity', 'quality of life (QOL', 'QOL and depressive symptom assessments', 'QOL', 'Quality of life']","[{'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",290.0,0.0234422,"Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence.","[{'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Vittengl', 'Affiliation': 'Department of Psychology, Truman State University, 100 East Normal Street, Kirksville, MO 63501-4221, USA. Electronic address: vittengl@truman.edu.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Minhajuddin', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania.'}, {'ForeName': 'Robin B', 'Initials': 'RB', 'LastName': 'Jarrett', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-9149, USA. Electronic address: Robin.Jarrett@UTSouthwestern.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.059']
1837,32971388,Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults.,"BACKGROUND


Cannabis warning labels can communicate risks, but there is little research on warning perceptions and differences by product type.
METHODS


In a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco) were randomly assigned to view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis. The warnings described cannabis risks related to psychosis, addiction, lack of FDA oversight, and impaired driving. We used linear regression to examine perceptions of warnings and product harm as a function of product type (dried or edible) and warning. We examined which warning participants selected as most effective for discouraging youth use and impaired driving.
RESULTS


Participants found the addiction warning (cannabis users: B = -1.04, p < 0.001; cannabis non-users: B = 1.17, p < 0.001) and psychosis warning (users: B = -0.65, p < 0.05; non-users: B = -0.71, p < 0.05) less believable than the driving warning but indicated that they learned more from the psychosis warning than the driving warning (users: B = 0.88, p < 0.01; non-users (B = 1.60, p < 0.001). Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05). The psychosis warning was most frequently selected as the best warning for discouraging youth use.
CONCLUSIONS


Warnings have the potential to educate consumers and impact cannabis harm perceptions. Warnings have similar effects across product types, potentially eliminating the need for product type-specific warnings. The association of cannabis use with risk for psychosis, a topic addressed in Canadian warnings, could be a useful topic of focus in U.S. warnings.",2020,Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05).,"['In a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco', 'Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults']",['view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis'],"['addiction warning', 'psychosis warning']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0556574', 'cui_str': 'Dried flowers'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]",,0.0480856,Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05).,"[{'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Pepper', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA. Electronic address: jpepper@rti.org.'}, {'ForeName': 'Youn Ok', 'Initials': 'YO', 'LastName': 'Lee', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Eggers', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Allen', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Nonnemaker', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108275']
1838,32971991,KiwiC for Vitality: Results of a Randomized Placebo-Controlled Trial Testing the Effects of Kiwifruit or Vitamin C Tablets on Vitality in Adults with Low Vitamin C Levels.,"Consumption of vitamin C-rich fruit and vegetables has been associated with greater feelings of vitality. However, these associations have rarely been tested in randomized controlled trials. The aim of the current study was to test the effects of eating a vitamin C-rich food (kiwifruit) on subjective vitality and whether effects are driven by vitamin C. Young adults ( n  = 167, 61.1% female, aged 18-35) with plasma vitamin C <40 µmol/L were randomized into three intervention conditions: kiwifruit (2 SunGold™ kiwifruit/day), vitamin C (250 mg tablet/day), placebo (1 tablet/day). The trial consisted of a two-week lead-in, four-week intervention, and two-week washout. Plasma vitamin C and vitality questionnaires (total mood disturbance, fatigue, and well-being) were measured fortnightly. Self-reported sleep quality and physical activity were measured every second day through smartphone surveys. Nutritional confounds were assessed using a three-day food diary during each study phase. Plasma vitamin C reached saturation levels within two weeks for the kiwifruit and vitamin C groups. Participants consuming kiwifruit showed significantly improved mood and well-being during the intervention period; improvements in well-being were sustained during washout. Decreased fatigue and increased well-being were observed following intake of vitamin C alone, but only for participants with consistently low vitamin C levels during lead-in. Diet records showed that participants consuming kiwifruit reduced their fat intake during the intervention period. Intervention effects remained significant when adjusting for age and ethnicity, and were not explained by sleep quality, physical activity, BMI, or other dietary patterns, including fat intake. There were no changes in plasma vitamin C status or vitality in the placebo group. Whole food consumption of kiwifruit improved subjective vitality in adults with low vitamin C status. Similar, but not identical, changes were found for vitamin C tablets suggesting that additional properties of kiwifruit may contribute to improved vitality.",2020,"Intervention effects remained significant when adjusting for age and ethnicity, and were not explained by sleep quality, physical activity, BMI, or other dietary patterns, including fat intake.","['KiwiC for Vitality', 'Young adults ( n  = 167, 61.1% female, aged 18-35) with plasma vitamin C <40 µmol/L', 'adults with low vitamin C status', 'Adults with Low Vitamin C Levels']","['intervention conditions: kiwifruit (2 SunGold™ kiwifruit/day), vitamin C', 'Kiwifruit or Vitamin C Tablets', 'eating a vitamin C-rich food (kiwifruit', 'placebo', 'Placebo', 'vitamin C-rich fruit and vegetables', 'vitamin C']","['Plasma vitamin C and vitality questionnaires (total mood disturbance, fatigue, and well-being', 'plasma vitamin C status or vitality', 'fat intake', 'Self-reported sleep quality and physical activity', 'Plasma vitamin C reached saturation levels', 'sleep quality, physical activity, BMI, or other dietary patterns, including fat intake', 'Decreased fatigue', 'subjective vitality']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0971874', 'cui_str': 'Actinidia deliciosa'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0453861', 'cui_str': 'Rich food'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",,0.202544,"Intervention effects remained significant when adjusting for age and ethnicity, and were not explained by sleep quality, physical activity, BMI, or other dietary patterns, including fat intake.","[{'ForeName': 'Tamlin S', 'Initials': 'TS', 'LastName': 'Conner', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin 9054, New Zealand.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Fletcher', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin 9054, New Zealand.'}, {'ForeName': 'Juliet M', 'Initials': 'JM', 'LastName': 'Pullar', 'Affiliation': 'Centre for Free Radical Research, Department of Pathology and Biomedical Science, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Spencer', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Mainvil', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin 9054, New Zealand.'}, {'ForeName': 'Margreet C M', 'Initials': 'MCM', 'LastName': 'Vissers', 'Affiliation': 'Centre for Free Radical Research, Department of Pathology and Biomedical Science, University of Otago, Christchurch 8140, New Zealand.'}]",Nutrients,['10.3390/nu12092898']
1839,32974838,"Direct comparison of two extended half-life PEGylated recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A.","An open-label, crossover randomized study was performed to compare the pharmacokinetics (PK) of damoctocog alfa pegol and rurioctocog alfa pegol, two recombinant factor VIII (FVIII) products indicated in patients with hemophilia A, both conjugated to polyethylene glycol to reduce clearance and extend time in circulation. Adult patients (N = 18) with severe hemophilia A (FVIII < 1 IU/dL), previously treated with any FVIII product for ≥ 150 exposure days, were randomized to receive a single 50 IU/kg infusion of damoctocog alfa pegol followed by rurioctocog alfa pegol, or vice versa, with ≥ 7-day washout between doses. FVIII activity was measured using the one-stage clotting assay. PK parameters, including area under the curve from time 0 to the last data point (AUC 0-tlast , primary parameter), dose-normalized AUC (AUC norm ), and time to threshold, were calculated based on 11 time points between 0.25 and 120 h post-dose and evaluated using a noncompartmental model. Due to differences in batch-specific vial content used for the study, actual administered median doses were 54.3 IU/kg for damoctocog alfa pegol and 61.4 IU/kg for rurioctocog alfa pegol. Based on actual dosing, a significantly higher geometric mean (coefficient of variation [%CV]) AUC norm  was observed for damoctocog alfa pegol (43.8 h kg/dL [44.0]) versus rurioctocog alfa pegol (36.0 h kg/dL [40.1, P < 0.001]). Based on population PK modeling, median time to reach 1 IU/dL was 16 h longer for damoctocog alfa pegol compared with rurioctocog alfa pegol. No adverse events or any immunogenicity signals were observed. Overall, damoctocog alfa pegol had a superior PK profile versus rurioctocog alfa pegol. Trial registration number: NCT04015492 ( ClinicalTrials.gov identifier). Date of registration: July 9, 2019.",2020,dL was 16 h longer for damoctocog alfa pegol compared with rurioctocog alfa pegol.,"['Adult patients (N = 18) with severe hemophilia A', 'patients with severe hemophilia A', 'patients with hemophilia A']","['damoctocog alfa pegol and rurioctocog alfa pegol, two recombinant factor VIII ', 'two extended half-life PEGylated recombinant FVIII products']","['geometric mean (coefficient of variation [%CV', 'FVIII activity', 'PK parameters, including area under the curve from time 0 to the last data point (AUC 0-tlast , primary parameter), dose-normalized AUC (AUC norm ), and time to threshold']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}]","[{'cui': 'C4723219', 'cui_str': 'damoctocog alfa pegol'}, {'cui': 'C0795577', 'cui_str': 'recombinant antihemophilic factor VIII'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0015506', 'cui_str': 'Factor VIII'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",18.0,0.109307,dL was 16 h longer for damoctocog alfa pegol compared with rurioctocog alfa pegol.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Solms', 'Affiliation': 'Clinical Pharmacometrics, Pharmaceuticals Research & Development, Bayer AG, 13353, Berlin, Germany. alexander.solms@bayer.com.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Bayer, Whippany, NJ, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Berntorp', 'Affiliation': 'Centre for Thrombosis and Haemostasis, Lund University, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Tiede', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Iorio', 'Affiliation': 'McMaster-Bayer Endowed Research Chair in Clinical Epidemiology of Congenital Bleeding Disorders, Department of Medicine, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Linardi', 'Affiliation': 'Bayer, Whippany, NJ, USA.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Ahsman', 'Affiliation': 'LAP&P Consultants BV, Leiden, the Netherlands.'}, {'ForeName': 'Maria Elisa', 'Initials': 'ME', 'LastName': 'Mancuso', 'Affiliation': 'Center for Thrombosis and Hemorrhagic Diseases, Humanitas Clinical and Research Center - IRCCS, Rozzano, Milan, Italy.'}, {'ForeName': 'Tihomir', 'Initials': 'T', 'LastName': 'Zhivkov', 'Affiliation': 'Specialized Hospital for Active Treatment, Sofia, Bulgaria.'}, {'ForeName': 'Toshko', 'Initials': 'T', 'LastName': 'Lissitchkov', 'Affiliation': 'Specialized Hospital for Active Treatment, Sofia, Bulgaria.'}]",Annals of hematology,['10.1007/s00277-020-04280-3']
1840,32976501,"The impact of Worms and Ladders, an innovative health educational board game on Soil-Transmitted Helminthiasis control in Abeokuta, Southwest Nigeria.","In most endemic sub-Saharan African countries, repeated infections with soil-transmitted helminth (STH) occur as early as six weeks after the end of mass drug administration (MDA) with albendazole. In this study, we designed a new health educational board game Worms and Ladders and evaluated its potential to complement MDA with albendazole and reduce reinfection rates through the promotion of good hygiene practices among school-aged children. The evaluation employed a randomized control trial (RCT) design. Baseline knowledge, attitude and practices (KAP) relating to STH were obtained using a questionnaire from 372 pupils across six schools in Abeokuta, Nigeria. Schools were randomly assigned into intervention and control group, with the former and latter receiving Worms and Ladders and the common Snake and Ladder board game respectively. Fresh stool samples were also collected at baseline for STH diagnosis before administering 400mg single dose albendazole. Follow-up assessments of STH burden and KAP were conducted three and six months' post-intervention. Data generated from the study were analyzed using SPSS 20.0 software, with confidence interval set at 95%. Prevalence of STH dropped from 25.0% to 10.4% in the intervention group and 49.4% to 33.3% in the control group at three months' post-intervention. The prevalence further dropped to 5.6% in the intervention group at six months' post-intervention. However, it increased to 37.2% in the control group at six months' post-intervention. There was a significant difference (p<0.05) in prevalence after intervention among the groups. KAP on transmission, control and prevention of STH significantly improved (p<0.05) from 5.2% to 97.9% in the intervention group compared to 6.2% to 7.1% in the control group. The Worms and Ladders board game shows the potential to teach and promote good hygiene behavior among SAC. These findings posit the newly developed game as a reliable tool to complement mass drug administration campaigns for STH control.",2020,"KAP on transmission, control and prevention of STH significantly improved (p<0.05) from 5.2% to 97.9% in the intervention group compared to 6.2% to 7.1% in the control group.","['Soil-Transmitted Helminthiasis control in Abeokuta, Southwest Nigeria', 'school-aged children', '372 pupils across six schools in Abeokuta, Nigeria']","['albendazole', 'KAP']","['transmission, control and prevention of STH', 'Baseline knowledge, attitude and practices (KAP', 'Prevalence of STH', 'reinfection rates']","[{'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0018889', 'cui_str': 'Helminth infection'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}]","[{'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]","[{'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0018893', 'cui_str': 'Helminth'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205339', 'cui_str': 'Reinfection'}]",,0.043445,"KAP on transmission, control and prevention of STH significantly improved (p<0.05) from 5.2% to 97.9% in the intervention group compared to 6.2% to 7.1% in the control group.","[{'ForeName': 'Dorcas B', 'Initials': 'DB', 'LastName': 'Bassey', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Ogun State, Nigeria.'}, {'ForeName': 'Hammed O', 'Initials': 'HO', 'LastName': 'Mogaji', 'Affiliation': 'Department of Animal and Environmental Biology, Federal University Oye-Ekiti, Ekiti State, Nigeria.'}, {'ForeName': 'Gabriel A', 'Initials': 'GA', 'LastName': 'Dedeke', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Ogun State, Nigeria.'}, {'ForeName': 'Bolanle I', 'Initials': 'BI', 'LastName': 'Akeredolu-Ale', 'Affiliation': 'Department of Communication and General Studies, Federal University of Agriculture, Abeokuta, Ogun State, Nigeria.'}, {'ForeName': 'Eniola M', 'Initials': 'EM', 'LastName': 'Abe', 'Affiliation': ""National Institute of Parasitic Disease and Control, China Centre for Disease Control, People's Republic of China.""}, {'ForeName': 'Akinola S', 'Initials': 'AS', 'LastName': 'Oluwole', 'Affiliation': 'COUNTDOWN project, Sightsavers, Nigeria Country Office, Nigeria.'}, {'ForeName': 'Abdulhakeem A', 'Initials': 'AA', 'LastName': 'Adeniran', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Ogun State, Nigeria.'}, {'ForeName': 'Olagunju A', 'Initials': 'OA', 'LastName': 'Agboola', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Ogun State, Nigeria.'}, {'ForeName': 'Chiedu F', 'Initials': 'CF', 'LastName': 'Mafiana', 'Affiliation': 'Directorate of Research and Innovation, National Open University of Nigeria, Abuja, Nigeria.'}, {'ForeName': 'Uwem F', 'Initials': 'UF', 'LastName': 'Ekpo', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Ogun State, Nigeria.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008486']
1841,32978183,Oral health improvement for nursing home residents through delegated remotivation and reinstruction (MundZaRR Study): study protocol of a cluster-randomised controlled trial.,"INTRODUCTION


Oral health and oral health-related quality of life (OHrQL) of residents in German long-term residential care (LRC) are poor. We will develop an evidence-based catalogue of interventions ('Oral Health Toolbox') and provide care-accompanying reinstruction and remotivation of nursing staff by dental assistants (DA). We hypothesise that such intervention will significantly improve OHrQL, daily oral hygiene/care behaviour and is cost-effective.
METHODS AND ANALYSIS


A scoping review will be used to identify possible intervention components. Mixed methods will be used to identify barriers and enablers of oral hygiene and care in German LRC. The result will be the 'Oral Health Toolbox', a two-phased instrument supporting both initial intervention allocation to improve oral health/hygiene and reinstruction/remotivation. A two-arm clustered, randomised controlled trial (ratio of 1:1 via block randomisation) will be performed in LRC in Rhineland-Palatinate, Germany. Each nursing home represents a cluster. Based on a feasibility study, considering clustering and possible attrition, we aim at recruiting 618 residents in 18 clusters. In the intervention group, dentists will assign one or more intervention component from the box (phase 1). During follow-up, nursing staff will be reinstructed and remotivated by DA, who use the box to decide how to maintain the intervention (phase 2). In the control group residents will receive care as usual. The primary outcome, OHrQL, will be measured using the General Oral Health Assessment Index. Secondary outcomes include pain condition, general health-related quality of life, caries increment, oral/prosthetic hygiene and gingival status, incidence of dental emergencies and hospitalisations, and cost-utility/effectiveness. The endpoints will be measured at baseline and after 12 months. For our primary outcome, a mixed-linear model will be used within an intention-to-treat analysis. A process evaluation using mixed methods will be conducted alongside the trial.
ETHICS AND DISSEMINATION


Ethical approval by the University of Kiel was granted (D480/18).
TRIAL REGISTRATION NUMBER


NCT04140929.",2020,"INTRODUCTION


Oral health and oral health-related quality of life (OHrQL) of residents in German long-term residential care (LRC) are poor.","['residents in German long-term residential care (LRC', '618 residents in 18 clusters']",[],"['OHrQL, daily oral hygiene/care behaviour', 'pain condition, general health-related quality of life, caries increment, oral/prosthetic hygiene and gingival status, incidence of dental emergencies and hospitalisations, and cost-utility/effectiveness', 'Oral health improvement', 'OHrQL, will be measured using the General Oral Health Assessment Index']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",618.0,0.135337,"INTRODUCTION


Oral health and oral health-related quality of life (OHrQL) of residents in German long-term residential care (LRC) are poor.","[{'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Hertrampf', 'Affiliation': 'Clinic of Oral and Maxillofacial Surgery, University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schlattmann', 'Affiliation': 'Medical Statistics, Computer and DataSciences, Friedrich-Schiller-Universitat Jena, Jena, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Meyer', 'Affiliation': 'Institute for Health Care and Nursing Studies, University Halle, Halle/Saale, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Gassmann', 'Affiliation': 'praxisHochschule pHfG Trägergesellschaft, praxisHochschule University of Applied Sciences, Cologne, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Abraham', 'Affiliation': 'Institute for Health Care and Nursing Studies, University Halle, Halle/Saale, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Hammen', 'Affiliation': 'praxisHochschule University of Applied Sciences, praxisHochschule University of Applied Sciences, Cologne, Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Schwendicke', 'Affiliation': 'Zahnerhaltung, Charite Universitatsmediz in Berlin Campus Benjamin Franklin, Berlin, Germany falk.schwendicke@charite.de.'}]",BMJ open,['10.1136/bmjopen-2019-035999']
1842,32978185,Enhanced Recovery after Intensive Care (ERIC): study protocol for a German stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes.,"INTRODUCTION


Survival after critical illness has noticeably improved over the last decades due to advances in critical care medicine. Besides, there is an increasing number of elderly patients with chronic diseases being treated in the intensive care unit (ICU). More than half of the survivors of critical illness suffer from medium-term or long-term cognitive, psychological and/or physical impairments after ICU discharge, which is recognised as post-intensive care syndrome (PICS). There are evidence-based and consensus-based quality indicators (QIs) in intensive care medicine, which have a positive influence on patients' long-term outcomes if adhered to.
METHODS AND ANALYSIS


The protocol of a multicentre, pragmatic, stepped wedge cluster randomised controlled, quality improvement trial is presented. During 3 predefined steps, 12 academic hospitals in Berlin and Brandenburg, Germany, are randomly selected to move in a one-way crossover from the control to the intervention condition. After a multifactorial training programme on QIs and clinical outcomes for site personnel, ICUs will receive an adapted, interprofessional protocol for a complex telehealth intervention comprising of daily telemedical rounds at ICU. The targeted sample size is 1431 patients. The primary objective of this trial is to evaluate the effectiveness of the intervention on the adherence to eight QIs daily measured during the patient's ICU stay, compared with standard of care. Furthermore, the impact on long-term recovery such as PICS-related, patient-centred outcomes including health-related quality of life, mental health, clinical assessments of cognition and physical function, all-cause mortality and cost-effectiveness 3 and 6 months after ICU discharge will be evaluated.
ETHICS AND DISSEMINATION


This protocol was approved by the ethics committee of the Charité-Universitätsmedizin, Berlin, Germany (EA1/006/18). The results will be published in a peer-reviewed scientific journal and presented at international conferences. Study findings will also be disseminated via the website (www.eric-projekt.net).
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03671447).",2020,"After a multifactorial training programme on QIs and clinical outcomes for site personnel, ICUs will receive an adapted, interprofessional protocol for a complex telehealth intervention comprising of daily telemedical rounds at ICU.","['elderly patients with chronic diseases being treated in the intensive care unit (ICU', '1431 patients', '12 academic hospitals in Berlin and Brandenburg, Germany']","['multifactorial training programme', 'critical care telehealth program']","['process quality and functional outcomes', 'health-related quality of life, mental health, clinical assessments of cognition and physical function, all-cause mortality and cost-effectiveness']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.211071,"After a multifactorial training programme on QIs and clinical outcomes for site personnel, ICUs will receive an adapted, interprofessional protocol for a complex telehealth intervention comprising of daily telemedical rounds at ICU.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Adrion', 'Affiliation': 'Institute for Medical Information Processing, Biometry and Epidemiology, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Bjoern', 'Initials': 'B', 'LastName': 'Weiss', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Paul', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Berger', 'Affiliation': 'Department of Health Care Management, Technical University of Berlin, Berlin, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Busse', 'Affiliation': 'Department of Health Care Management, Technical University of Berlin, Berlin, Germany.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Marschall', 'Affiliation': 'BARMER, Wuppertal, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Caumanns', 'Affiliation': 'Fraunhofer Institute for Open Communication Systems, Berlin, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Rosseau', 'Affiliation': 'Weaning and Ventilation Centre, Ernst von Bergmann Klinikum, Bad Belzig, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mansmann', 'Affiliation': 'Institute for Medical Information Processing, Biometry and Epidemiology, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Spies', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany claudia.spies@charite.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036096']
1843,32978188,Efficacy of acupuncture versus sham acupuncture or waitlist control for patients with chronic plantar fasciitis: study protocol for a two-centre randomised controlled trial.,"INTRODUCTION


Plantar fasciitis (PF) is reported to be the most common cause of plantar heel pain. Acupuncture has been used for patients experiencing PF, but evidence of the efficacy of acupuncture on PF is limited. The primary objective of this trial is to compare combined acupuncture and sham acupuncture (SA) versus waitlist control for improving the level of pain experienced by patients suffering from chronic PF.
METHODS AND ANALYSIS


This will be a two-centre, parallel-group, sham and no-treatment controlled, assessor-blinded randomised trial. We will randomly allocate 120 participants with chronic PF to acupuncture, SA and waitlist control groups at a ratio of 2:1:1. Participants in the acupuncture and SA groups will receive a 30 min acupuncture or SA treatment for a total of 12 sessions over 4 weeks, with a 12-week follow-up. Participants in the waitlist control group will not undergo treatment for a period of 16 weeks but instead will have the option of 4 weeks (12 sessions) of acupuncture free of charge at the end of the follow-up period. The primary outcome will be the treatment response rate 4 weeks after randomisation, assessed as a minimum of 50% improvement in the worst pain intensity during the first steps in the morning compared with the baseline. All analyses will be performed with a two-sided p value of <0.05 considered significant following the intention-to-treat principle.
ETHICS AND DISSEMINATION


The study has been approved by the Ethical Committee of the Guang'anmen Hospital, China Academy of Chinese Medical Sciences (approval no. 2019-210-KY). The results will be disseminated through presentation at a peer-reviewed medical journal, the relevant conferences and scientific meetings.
TRIAL REGISTRATION


NCT04185259.",2020,Participants in the waitlist control group will not undergo treatment for a period of 16 weeks but instead will have the option of 4 weeks (12 sessions) of acupuncture free of charge at the end of the follow-up period.,"['120 participants with chronic PF to acupuncture, SA and waitlist control groups at a ratio of 2:1:1', 'patients with chronic plantar fasciitis', 'patients suffering from chronic PF']","['Acupuncture', '30\u2009min acupuncture or SA', 'acupuncture versus sham acupuncture', 'acupuncture and sham acupuncture (SA', 'acupuncture']","['worst pain intensity', 'treatment response rate']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1136148', 'cui_str': 'Fasciitis, Plantar, Chronic'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",120.0,0.197437,Participants in the waitlist control group will not undergo treatment for a period of 16 weeks but instead will have the option of 4 weeks (12 sessions) of acupuncture free of charge at the end of the follow-up period.,"[{'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Acupuncture and Moxibustion Department, China Academy of Traditional Chinese Medicine Guang'anmen Hospital, Xicheng District, China.""}, {'ForeName': 'Sixing', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Guizhou University of Traditional Chinese Medicine, Guiyang City, Guizhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Zang', 'Affiliation': 'Department of Acupuncture, Yantai Hospital of Traditional Chinese Medicine, Yantai, China.'}, {'ForeName': 'Weina', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Acupuncture and Moxibustion Department, China Academy of Traditional Chinese Medicine Guang'anmen Hospital, Xicheng District, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound, China Academy of Chinese Medical Sciences Guanganmen Hospital, Xicheng District, Beijing, China.'}, {'ForeName': 'Zhishun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Acupuncture and Moxibustion Department, China Academy of Traditional Chinese Medicine Guang'anmen Hospital, Xicheng District, China zhishunjournal@163.com.""}]",BMJ open,['10.1136/bmjopen-2020-036773']
1844,32978193,Cadaveric simulation versus standard training for postgraduate trauma and orthopaedic surgical trainees: protocol for the CAD:TRAUMA study multicentre randomised controlled educational trial.,"INTRODUCTION


The quantity and quality of surgical training in the UK has been negatively affected by reduced working hours and National Health Service (NHS) financial pressures. Traditionally surgical training has occurred by the master-apprentice model involving a process of graduated responsibility, but a modern alternative is to use simulation for the early stages of training. It is not known if simulation training for junior trainees can safeguard patients and improve clinical outcomes. This paper details the protocol for a multicentre randomised controlled educational trial of a cadaveric simulation training intervention versus standard training for junior postgraduate orthopaedic surgeons-in-training. This is the first study to assess the effect of cadaveric simulation training for open surgery on patient outcome. The feasibility of delivering cadaveric training, use of radiographic and clinical outcome measures to assess impact and the challenges of upscaling provision will be explored.
METHODS AND ANALYSIS


We will recruit postgraduate orthopaedic surgeons-in-training in the first 3 years (of 8) of the specialist training programme. Participants will be block randomised and allocated to either cadaveric simulation or standard 'on-the-job' training, learning three common orthopaedic procedures, each of which is a substudy within the trial. The procedures are (1) dynamic hip screw, (2) hemiarthroplasty and (3) ankle fracture fixation. These procedures have been selected as they are very common procedures which are routinely performed by junior surgeons-in-training. A pragmatic approach to sample size is taken in lieu of a formal power calculation as this is novel exploratory work with no a priori estimate of effect size to reference. The primary outcome measure is the technical success of the surgery performed on patients by the participating surgeons-in-training during the follow-up period for the three substudy procedures, as measured by the implant position on the postoperative radiograph. The secondary outcome measures are procedure time, postoperative complication rate and patient health state at 4 months postoperation (EQ-5D-substudies 1 and 2 only).
ETHICS, REGISTRATION AND DISSEMINATION


National research ethics approval was granted for this study by the NHS Research Authority South Birmingham Research Ethics Committee (15/WM/0464). Confidentiality Advisory Group approval was granted for accessing radiographic and outcome data without patient consent on 27 February 2017 (16/CAG/0125). The results of this trial will be submitted to a peer-reviewed journal and will inform educational and clinical practice.
TRIAL REGISTRATION NUMBER


ISRCTN20431944.",2020,"Participants will be block randomised and allocated to either cadaveric simulation or standard 'on-the-job' training, learning three common orthopaedic procedures, each of which is a substudy within the trial.","['junior postgraduate orthopaedic surgeons-in-training', 'postgraduate trauma and orthopaedic surgical trainees', 'postgraduate orthopaedic surgeons-in-training in the first 3\u2009years (of 8) of the specialist training programme']","[""cadaveric simulation or standard 'on-the-job' training, learning three common orthopaedic procedures"", 'cadaveric simulation training intervention versus standard training', 'Cadaveric simulation versus standard training', 'cadaveric training', 'cadaveric simulation training']","['procedure time, postoperative complication rate and patient health state at 4 months postoperation (EQ-5D-substudies 1 and 2 only', 'technical success of the surgery performed on patients by the participating surgeons-in-training', 'postoperative radiograph']","[{'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0524852', 'cui_str': 'Orthopaedic procedure'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]",,0.0994631,"Participants will be block randomised and allocated to either cadaveric simulation or standard 'on-the-job' training, learning three common orthopaedic procedures, each of which is a substudy within the trial.","[{'ForeName': 'Hannah K', 'Initials': 'HK', 'LastName': 'James', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, UK h.smith.1@warwick.ac.uk.'}, {'ForeName': 'Giles T R', 'Initials': 'GTR', 'LastName': 'Pattison', 'Affiliation': 'Trauma & Orthopaedic Surgery, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Joanne D', 'Initials': 'JD', 'LastName': 'Fisher', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, UK.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Griffin', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, UK.'}]",BMJ open,['10.1136/bmjopen-2020-037319']
1845,32980788,Acceptability of real-time video counselling compared to other behavioural interventions for smoking cessation in rural and remote areas.,"BACKGROUND


This study evaluated the acceptability of real-time video counselling compared to a) telephone counselling and b) written materials in assisting rural and remote residents to quit smoking.
METHODS


Participants were recruited into a three-arm, parallel group randomised trial and randomly allocated to either: a) real-time video counselling; b) telephone counselling; or c) written materials. At 4-months post-baseline participants completed an online survey that examined self-reported acceptability and helpfulness of the support.
RESULTS


Overall, 93.5 % of video counselling participants and 96.2 % of telephone counselling participants who received support thought it was acceptable for a smoking cessation advisor to contact them via video software or telephone respectively. There were significant differences between video counselling and telephone counselling groups on three of 10 acceptability or helpfulness measures. Video counselling participants had significantly lower odds of reporting the number of calls were about right (OR 0.50, 95 % CI 0.27-0.93), recommending the support to family and friends (OR 0.18, 95 % CI 0.04-0.85) and reporting the support helped with motivation to try quitting (OR 0.24, 95 % CI 0.07-0.76) compared to telephone counselling participants. Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
CONCLUSIONS


Real-time video counselling for smoking cessation is acceptable and well-received by those living in rural and remote locations. Further research is required to enhance the three attributes that were less acceptable for video counselling than telephone counselling.",2020,"Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
","['Participants', 'smoking cessation in rural and remote areas', 'assisting rural and remote residents to quit smoking']","['behavioural interventions', 'real-time video counselling compared to a) telephone counselling and b) written materials', 'real-time video counselling; b) telephone counselling; or c) written materials', 'Video counselling', 'real-time video counselling', 'video counselling']",['number of calls'],"[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",,0.115344,"Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Byaruhanga', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia. Electronic address: Judith.byaruhanga@uon.edu.au.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Byrnes', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Tzelepis', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108296']
1846,32980853,Comparison of Effectiveness of Routine Antenatal Care with a Midwife-Managed Clinic Service in Prevention of Gestational Diabetes Mellitus in Early Pregnancy at a Hospital in China.,"BACKGROUND Women with normal fasting glucose (FPG) range (5.1 ≤FPG <6.09 mmol/L) in early pregnancy are at high risk of gestational diabetes mellitus (GDM). The aim of this study was to compare the effectiveness of routine antenatal care with a midwife-managed clinic service in the prevention of GDM in early pregnancy at a hospital in China. MATERIAL AND METHODS We designed a prospective observational clinical study among pregnancy women with normal fasting glucose (FPG) range (5.1 ≤FPG <6.09 mmol/L) in early pregnancy. Routine antenatal care was compared with a midwife-managed clinic service providing diet and exercise education before week 16. A 75-g OGTT was performed at weeks 24-28 for both groups. Results of OGTT and gestational weight gain were compared between the 2 groups. RESULTS Of the 592 eligible women, 296 women received the antenatal nursing clinic service and 296 were enrolled in a control group. Thirty-three women were lost to follow-up during the study, leaving 279 in the intervention group and 280 in the control group. Baseline demographic characteristics were similar between the 2 groups. GDM was diagnosed in 115 participants (41.2%) in the intervention group and 141 (50.4%) in the control group. Subgroup analysis showed a significantly lower rate of GDM in the intervention group among the No-IVF population (37.8% vs. 49.0%, P=0.01%). For pre-pregnancy BMI, significant differences were found in the incidence of GDM and maternal hypertension between the different groups, showing that the overweight group benefited most from the midwife-managed antenatal clinic service. CONCLUSIONS The midwife-managed clinic service was feasible and effective in the prevention of GDM.",2020,"For pre-pregnancy BMI, significant differences were found in the incidence of GDM and maternal hypertension between the different groups, showing that the overweight group benefited most from the midwife-managed antenatal clinic service.","['pregnancy women with normal fasting glucose (FPG) range (5.1 ≤FPG <6.09 mmol/L) in early pregnancy', 'Gestational Diabetes Mellitus in Early Pregnancy at a Hospital in China', '296 women received the antenatal nursing clinic service and 296 were enrolled in a control group', 'Thirty-three women were lost to follow-up during the study, leaving 279 in the intervention group and 280 in the control group', 'Women with normal fasting glucose (FPG) range (5.1 ≤FPG <6.09 mmol/L) in early pregnancy are at high risk of gestational diabetes mellitus (GDM', 'early pregnancy at a hospital in China', '592 eligible women']","['Routine Antenatal Care with a Midwife-Managed Clinic Service', 'routine antenatal care with a midwife-managed clinic service']","['incidence of GDM and maternal hypertension', 'rate of GDM', 'Baseline demographic characteristics', 'OGTT and gestational weight gain', 'GDM']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C1276362', 'cui_str': 'Routine antenatal care'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0565599', 'cui_str': 'Maternal hypertension'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}]",592.0,0.0773553,"For pre-pregnancy BMI, significant differences were found in the incidence of GDM and maternal hypertension between the different groups, showing that the overweight group benefited most from the midwife-managed antenatal clinic service.","[{'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Nursing Department, The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai JiaoTong University, Shanghai, China (mainland).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Nursing Department, The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai JiaoTong University, Shanghai, China (mainland).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Nursing Department, The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai JiaoTong University, Shanghai, China (mainland).'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Research and Education Department, The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai JiaoTong University, Shanghai, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.925991']
1847,32987199,Pharmacodynamics of asfotase alfa in adults with pediatric-onset hypophosphatasia.,"BACKGROUND


Hypophosphatasia (HPP) is the rare, inherited, metabolic bone disease characterized by low activity of the tissue-nonspecific isoenzyme of alkaline phosphatase (TNSALP) leading to excess extracellular inorganic pyrophosphate (PPi) and pyridoxal 5'-phosphate (PLP). Asfotase alfa is the human recombinant enzyme-replacement therapy that replaces deficient TNSALP. However, there is limited information concerning the appropriate dose of asfotase alfa for adult patients with pediatric-onset HPP. Thus, we evaluated the pharmacodynamics and safety/tolerability of different doses of asfotase alfa in such patients.
METHODS


This 13-week, Phase 2a, open-label study enrolled adults (aged ≥18 years) with pediatric-onset HPP. They were randomized 1:1:1 to receive a single subcutaneous dose of asfotase alfa (0.5, 2.0, or 3.0 mg/kg) at Week 1, then 3 times per week (ie, 1.5, 6.0, or 9.0 mg/kg/wk) starting at Week 3 for 7 weeks. Key outcome measures included change from Baseline to before the third dose during Week 9 (trough) in plasma PPi (primary outcome measure) and PLP (secondary outcome measure).
RESULTS


Twenty-seven adults received asfotase alfa 0.5 (n = 8), 2.0 (n = 10), and 3.0 (n = 9) mg/kg; all completed the study. Median (range) age was 45 (18-77) years; most patients were white (96%) and female (59%). Median plasma PPi and PLP concentrations decreased from Baseline to Week 9 in all 3 cohorts. Differences in least squares mean (LSM) changes in PPi were significant with 2.0 mg/kg (p = 0.0008) and 3.0 mg/kg (p < 0.0001) vs. 0.5 mg/kg. Differences in LSM changes in PLP were also significant for 2.0 mg/kg (p = 0.0239) and 3.0 mg/kg (p = 0.0128) vs. 0.5 mg/kg. Injection site reactions were the most frequent treatment-emergent adverse event (78%), showing increasing frequency with increasing dose.
CONCLUSIONS


Adults with pediatric-onset HPP receiving asfotase alfa at 6.0 mg/kg/wk (the recommended dose) or 9.0 mg/kg/wk had greater reductions in circulating PPi and PLP concentrations compared with a lower dose of 1.5 mg/kg/wk.
TRIAL REGISTRATION


Clinicaltrials.gov identifier NCT02797821.",2020,"Injection site reactions were the most frequent treatment-emergent adverse event (78%), showing increasing frequency with increasing dose.
","['Adults with pediatric-onset HPP receiving', 'Twenty-seven adults received asfotase alfa 0.5 (n=8), 2.0 (n=10), and 3.0 (n=9) mg/kg; all completed the study', 'adult patients with pediatric-onset HPP', 'Adults With Pediatric-Onset Hypophosphatasia', 'Median (range) age was 45 (18-77) years; most patients were white (96%) and female (59', '13-week, Phase 2a, open-label study enrolled adults (aged ≥18 years) with pediatric-onset HPP']","['single subcutaneous dose of asfotase alfa', 'asfotase alfa', 'Asfotase Alfa']","['Least squares mean (LSM) changes in PPi', 'LSM differences in PLP changes', 'change from Baseline to before the third dose during Week 9 (trough) in plasma PPi (primary outcome measure) and PLP (secondary outcome measure', 'circulating PPi and PLP concentrations', 'Median plasma PPi and PLP concentrations', 'pharmacodynamics and safety/tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0020630', 'cui_str': 'Hypophosphatasia'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C3490795', 'cui_str': 'asfotase alfa'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3490795', 'cui_str': 'asfotase alfa'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0034266', 'cui_str': 'pyridoxal phosphate'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.169277,"Injection site reactions were the most frequent treatment-emergent adverse event (78%), showing increasing frequency with increasing dose.
","[{'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Seefried', 'Affiliation': 'Orthopedic Department, University of Würzburg, Würzburg, Bavaria, Germany. Electronic address: l-seefried.klh@uni-wuerzburg.de.'}, {'ForeName': 'Priya S', 'Initials': 'PS', 'LastName': 'Kishnani', 'Affiliation': 'Department of Pediatrics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Moseley', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Denker', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Watsky', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Whyte', 'Affiliation': 'Center for Metabolic Bone Disease and Molecular Research, Shriners Hospitals for Children-St. Louis, St. Louis, MO, USA; Division of Bone and Mineral Diseases, Department of Internal Medicine, Washington University School of Medicine at Barnes-Jewish Hospital, St Louis, MO, USA.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Dahir', 'Affiliation': 'Program for Metabolic Bone Disorders at Vanderbilt, Division of Diabetes and Endocrinology, Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Bone,['10.1016/j.bone.2020.115664']
1848,32987210,"A commentary on ""A randomized controlled trial on irrigation of open appendectomy wound with gentamicin-saline solution versus saline solution for prevention of surgical site infection"" [Int. J. Surg. 81 (2020) 140-146].",,2020,,[],['Gentamicin-Saline Solution Versus Saline Solution'],[],[],"[{'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]",[],,0.29653,,"[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Man', 'Affiliation': 'GKT School of Medical Education, Hodgkin Building, Newcomen Street, London, SE1 1UL, United Kingdom. Electronic address: julian.man@kcl.ac.uk.'}, {'ForeName': 'Bennett', 'Initials': 'B', 'LastName': 'Choy', 'Affiliation': 'University College London Hospital, 250 Euston Road, London, NW1 2PG, United Kingdom. Electronic address: b.choy@nhs.net.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.09.028']
1849,32987227,Family Integrated Care (FICare): Positive impact on behavioural outcomes at 18 months.,"BACKGROUND


Children born very preterm demonstrate behavioural challenges due to clinical factors, exposure to the high stress environment of intensive care, and separation from parents during neonatal hospitalization at a critical stage in development. Family Integrated Care (FICare) significantly reduced parent stress and anxiety, and improved neonatal outcomes.
AIMS


To examine the impact of FICare on behavioural outcomes at 18-21 months corrected age (CA), and assess possible mediation through parenting or infant growth.
STUDY DESIGN AND METHODS


A prospective cohort study enrolling infants under 33 weeks gestation and parents from the FICare cluster randomized controlled trial. Primary outcome was behaviour assessed by the Infant Toddler Social Emotional Assessment (ITSEA). Parent child variables were measured with the Nursing Child Assessment Satellite Training (NCAST), Parenting Stress Index (PSI) and infant growth.
RESULTS


Subjects included 123 FICare infants and 62 standard care controls evaluated at 18-21 months CA. FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01). At 12 months CA, the NCAST Child subtotal score was higher and the PSI-Child Domain score was lower in FICare infants than non-FICare infants. The PSI-Child domain was identified as a possible mediator of FICare on child behaviour (mediation effect 1.28, -2.96-0.02, p = 0.044).
CONCLUSION


FICare in the NICU has a sustained effect on child behaviour, improving self-regulation at 18-21 months CA.",2020,"FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01).","['A prospective cohort study enrolling infants under 33\xa0weeks gestation and parents from the FICare cluster randomized controlled trial', 'Children born very preterm', 'Subjects included 123 FICare infants and 62 standard care controls evaluated at 18-21\xa0months CA']","['FICare', 'Family Integrated Care (FICare']","['parent stress and anxiety, and improved neonatal outcomes', 'Nursing Child Assessment Satellite Training (NCAST), Parenting Stress Index (PSI) and infant growth', 'behavioural outcomes', 'PSI-Child Domain score', 'lower ITSEA Dysregulation', 'NCAST Child subtotal score', 'behaviour assessed by the Infant Toddler Social Emotional Assessment (ITSEA', 'self-regulation skills', 'child behaviour, improving self-regulation']","[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021272', 'cui_str': 'Infant care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036238', 'cui_str': 'Associated Viruses'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]",123.0,0.0623273,"FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01).","[{'ForeName': 'Paige Terrien', 'Initials': 'PT', 'LastName': 'Church', 'Affiliation': ""Sunnybrook Health Sciences Centre, Department of Newborn and Developmental Paediatrics, 2075 Bayview Avenue, M4-234, Toronto, ON M4N 3M5, Canada; University of Toronto, Department of Paediatrics, 27 King's College Cir, Toronto, ON M5S 3H7, Canada.""}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Grunau', 'Affiliation': ""University of British Columbia, Department of Pediatrics and BC Children's Research Institute, 4500 Oak Street, Vancouver, BC V6H 3N1, Canada; BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Mirea', 'Affiliation': 'Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Petrie', 'Affiliation': ""BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Amuchou Singh', 'Initials': 'AS', 'LastName': 'Soraisham', 'Affiliation': ""Alberta Children's Hospital Research Institute, Foothills Medical Centre, University of Calgary, 1403, 29th Street NW, Calgary, AB T2N 2T9, Canada.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Synnes', 'Affiliation': ""University of British Columbia, Department of Pediatrics and BC Children's Research Institute, 4500 Oak Street, Vancouver, BC V6H 3N1, Canada; BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Xiang Y', 'Initials': 'XY', 'LastName': 'Ye', 'Affiliation': 'Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': ""O'Brien"", 'Affiliation': ""University of Toronto, Department of Paediatrics, 27 King's College Cir, Toronto, ON M5S 3H7, Canada; Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada; Mount Sinai Hospital, Department of Paediatrics, 600 University Avenue, Toronto, ON M5G 1X5, Canada. Electronic address: karel.obrien@sinaihealth.ca.""}]",Early human development,['10.1016/j.earlhumdev.2020.105196']
1850,32987282,Fundamental frequency during cognitive preparation and its impact on therapy outcome for panic disorder with Agoraphobia.,"BACKGROUND


Cognitive preparation plays a crucial role in CBT with exposure for panic disorder and agoraphobia. High emotional arousal while developing the exposure rationale might impair patients' cognitive capacities for processing information about treatment and impede therapeutic outcome.
OBJECTIVE


This study investigates whether patients' vocally encoded emotional arousal, assessed by fundamental frequency (f 0 ), during rationale development is associated with premature treatment dropout, insight into the rationale, and symptom reduction.
METHODS


Patients' (N = 197, mean age 36.1 years, 79.2% female) f 0  during rationale development was measured based on treatment videos from a randomized controlled trial of CBT for panic disorder and agoraphobia. Insight was rater assessed. Symptom severity was self- and rater assessed at the beginning and end of therapy.
RESULTS


Higher f 0  mean during rationale development was associated with lower probability of insight and less reduction in avoidance behavior. f 0  was not associated with dropout. Insight was associated with lower probability of dropout and partially mediated the association between f 0  and avoidance reduction.
DISCUSSION


This study highlights the importance of emotional arousal during cognitive preparation for exposure. Therapists should ensure that patients are not too highly aroused while learning about the exposure rationale as an important step in treatment.",2020,f 0  during rationale development was measured based on treatment videos from a randomized controlled trial of CBT for panic disorder and agoraphobia.,"['panic disorder with Agoraphobia', ""Patients' (N\xa0=\xa0197, mean age 36.1 years, 79.2% female""]",['CBT'],['avoidance behavior'],"[{'cui': 'C0236800', 'cui_str': 'Panic disorder with agoraphobia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}]",,0.0479158,f 0  during rationale development was measured based on treatment videos from a randomized controlled trial of CBT for panic disorder and agoraphobia.,"[{'ForeName': 'Gesine', 'Initials': 'G', 'LastName': 'Wieder', 'Affiliation': 'Institute for Clinical Psychology and Psychotherapy, Dresden University of Technology, Chemnitzer Strasse 46, 01187, Dresden, Germany; Department of Differential and Personality Psychology, Dresden University of Technology, Zellescher Weg 17, 01069, Dresden, Germany. Electronic address: gesine.wieder@tu-dresden.de.'}, {'ForeName': 'Melanie S', 'Initials': 'MS', 'LastName': 'Fischer', 'Affiliation': 'Institute of Medical Psychology, Heidelberg University Hospital, Bergheimer Strasse 20, 69115, Heidelberg, Germany; Faculty of Behavioural and Cultural Studies, Ruprecht-Karls University Heidelberg, Voßstrasse 2, 69115, Heidelberg, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Einsle', 'Affiliation': 'Institute for Clinical Psychology and Psychotherapy, Dresden University of Technology, Chemnitzer Strasse 46, 01187, Dresden, Germany.'}, {'ForeName': 'Donald H', 'Initials': 'DH', 'LastName': 'Baucom', 'Affiliation': 'Department of Psychology and Neuroscience, Davie Hall, CB #3270, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599-3270, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Hahlweg', 'Affiliation': 'Institute for Psychology, Department of Clinical Psychology, Psychotherapy and Diagnostics, Technische Universitaet Braunschweig, Mail address: Schwäbische Str. 7, 10781, Berlin, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute for Clinical Psychology and Psychotherapy, Dresden University of Technology, Chemnitzer Strasse 46, 01187, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet, Nussbaumstraße 7, 80336, Munich, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Weusthoff', 'Affiliation': 'Institute for Psychology, Department of Clinical Psychology, Psychotherapy and Diagnostics, Technische Universitaet Braunschweig, Mail address: Schwäbische Str. 7, 10781, Berlin, Germany; Private Psychotherapeutic Practice, Everswinkeler Strasse 4, 48351, Alverskirchen, Germany.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103728']
1851,32987332,Lamotrigine for reducing ketamine-induced psychologic disturbances: A pilot randomized and blinded trial.,,2020,,['induced psychologic disturbances'],"['ketamine', 'Lamotrigine']",[],"[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}]",[],,0.14572,,"[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America. Electronic address: MAHESHK@ccf.org.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Bakal', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Xuan', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Wael Ali Sakr', 'Initials': 'WAS', 'LastName': 'Esa', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'Department of Psychiatry, Cleveland Clinic, Cleveland, OH, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110074']
1852,32991758,Metabolic phenotypes of early gestational diabetes mellitus and their association with adverse pregnancy outcomes.,"AIMS


To describe the metabolic phenotypes of early gestational diabetes mellitus and their association with adverse pregnancy outcomes.
METHODS


We performed a post hoc analysis using data from the Vitamin D And Lifestyle Intervention for gestational diabetes prevention (DALI) trial conducted across nine European countries (2012-2014). In women with a BMI ≥29 kg/m 2  , insulin resistance and secretion were estimated from the oral glucose tolerance test values performed before 20 weeks, using homeostatic model assessment of insulin resistance and Stumvoll first-phase indices, respectively. Women with early gestational diabetes, defined by the International Association of Diabetes and Pregnancy Study Groups criteria, were classified into three groups: GDM-R (above-median insulin resistance alone), GDM-S (below-median insulin secretion alone), and GDM-B (combination of both) and the few remaining women were excluded.
RESULTS


Compared with women in the normal glucose tolerance group (n = 651), women in the GDM-R group (n = 143) had higher fasting and post-load glucose values and insulin levels, with a greater risk of having large-for-gestational age babies [adjusted odds ratio 3.30 (95% CI 1.50-7.50)] and caesarean section [adjusted odds ratio 2.30 (95% CI 1.20-4.40)]. Women in the GDM-S (n = 37) and GDM-B (n = 56) groups had comparable pregnancy outcomes with those in the normal glucose tolerance group.
CONCLUSIONS


In overweight and obese women with early gestational diabetes, higher degree of insulin resistance alone was more likely to be associated with adverse pregnancy outcomes than lower insulin secretion alone or a combination of both.",2020,"Compared with women in the normal glucose tolerance group (n = 651), women in the GDM-R group (n = 143) had higher fasting and post-load glucose values and insulin levels, with a greater risk of having large-for-gestational age babies [adjusted odds ratio 3.30 (95% CI 1.50-7.50)] and caesarean section [adjusted odds ratio 2.30 (95% CI 1.20-4.40)].","['early gestational diabetes mellitus', 'overweight and obese women with early gestational diabetes', 'gestational diabetes prevention (DALI) trial conducted across nine European countries (2012-2014', 'Women with early gestational diabetes, defined by the International Association of Diabetes and Pregnancy Study Groups criteria, were classified into three groups: GDM-R (above-median insulin resistance alone), GDM-S (below-median insulin secretion alone), and GDM-B (combination of both) and the few remaining women were excluded']",['Vitamin D And Lifestyle Intervention'],"['insulin resistance and secretion', 'caesarean section', 'adverse pregnancy outcomes', 'higher fasting and post-load glucose values and insulin levels', 'pregnancy outcomes']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}]",,0.0984678,"Compared with women in the normal glucose tolerance group (n = 651), women in the GDM-R group (n = 143) had higher fasting and post-load glucose values and insulin levels, with a greater risk of having large-for-gestational age babies [adjusted odds ratio 3.30 (95% CI 1.50-7.50)] and caesarean section [adjusted odds ratio 2.30 (95% CI 1.20-4.40)].","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Immanuel', 'Affiliation': 'Macarthur Clinical School, Western Sydney University, Sydney, NSW, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Simmons', 'Affiliation': 'Macarthur Clinical School, Western Sydney University, Sydney, NSW, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Harreiter', 'Affiliation': 'Department of Medicine III, Division of Endocrinology, Gender Medicine Unit, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Desoye', 'Affiliation': 'Department of Obstetrics and Gynecology, Medizinische Universitaet Graz, Graz, Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Corcoy', 'Affiliation': 'Department of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Adelantado', 'Affiliation': 'Department of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Devlieger', 'Affiliation': 'KU Leuven Department of Development and Regeneration: Pregnancy, Fetus and Neonate, Leuven, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lapolla', 'Affiliation': 'Universita Degli Studi di Padova, Padua, Italy.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Dalfra', 'Affiliation': 'Universita Degli Studi di Padova, Padua, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bertolotto', 'Affiliation': 'Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Wender-Ozegowska', 'Affiliation': 'Department of Reproduction, Poznan University of Medical Sciences, Poland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zawiejska', 'Affiliation': 'Department of Reproduction, Poznan University of Medical Sciences, Poland.'}, {'ForeName': 'F P', 'Initials': 'FP', 'LastName': 'Dunne', 'Affiliation': 'National University of Ireland, Galway, Ireland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Damm', 'Affiliation': 'Centre for Pregnant Women with Diabetes, Departments of Endocrinology and Obstetrics, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Mathiesen', 'Affiliation': 'Centre for Pregnant Women with Diabetes, Departments of Endocrinology and Obstetrics, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Jensen', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'L L T', 'Initials': 'LLT', 'LastName': 'Andersen', 'Affiliation': 'Department of Gynecology and Obstetrics, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Hill', 'Affiliation': 'Recherche en Santé Lawson SA, St. Gallen, Switzerland.'}, {'ForeName': 'J G M', 'Initials': 'JGM', 'LastName': 'Jelsma', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kautzky-Willer', 'Affiliation': 'Department of Medicine III, Division of Endocrinology, Gender Medicine Unit, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Galjaard', 'Affiliation': 'KU Leuven Department of Development and Regeneration: Pregnancy, Fetus and Neonate, Leuven, Belgium.'}, {'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Snoek', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Medical Psychology, Amsterdam, The Netherlands.'}, {'ForeName': 'M N M', 'Initials': 'MNM', 'LastName': 'van Poppel', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14413']
1853,32991776,A novel risk assessment model of contrast-induced nephropathy after percutaneous coronary intervention in patients with diabetes.,"The purpose of our study was to develop a simple clinical pre-procedure risk model based on clinical characteristics for the prediction of contrast-induced nephropathy (CIN) and major adverse cardiac events (MACEs) after percutaneous coronary intervention (PCI) in patients with diabetes. A total of 1113 patients with diabetes who underwent PCI with contrast exposure were randomized into a development group (n = 742) and a validation group (n = 371) in a 2:1 ratio. CIN was defined as an increase of either 25% or 0.5 mg/dL (44.2 μmol/L) in serum creatinine within 72 hours after contrast infusion. A simple CIN risk score based on independent predictors was established. Four variables were identified for our risk score model: LVEF < 40%, acute coronary syndrome (ACS), eGFR < 60, and contrast volume > 300 mL. Based on this new CIN risk score, the incidence of CIN had a significant trend with increased predicting score values of 5.9%, 32.9% and 60.0%, corresponding to low-, moderate- and high-risk groups, respectively. The novel risk assessment exhibited moderate discrimination ability for predicting CIN, with an AUC of 0.759 [95% CI 0.668-0.852, P = .001] in the validation cohort. It also had similar prognostic values for one-year follow-up MACE (C-statistic: 0.705 and 0.606 for new risk score and Mehran score, respectively). This novel risk prediction model could be effective for preventing nephropathy in diabetic patients receiving contrast media during surgical procedures.",2020,"The novel risk assessment exhibited moderate discrimination ability for predicting CIN, with an AUC of 0.759 [95% CI 0.668-0.852, P = 0.001] in the validation cohort.","['Patients with Diabetes', 'diabetic patients receiving contrast media during surgical procedures', '1113 patients with diabetes who underwent PCI with contrast exposure', 'patients with diabetes']","['percutaneous coronary intervention (PCI', 'Percutaneous Coronary Intervention']","['serum creatinine', 'new CIN risk score', 'CIN']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",1113.0,0.0163806,"The novel risk assessment exhibited moderate discrimination ability for predicting CIN, with an AUC of 0.759 [95% CI 0.668-0.852, P = 0.001] in the validation cohort.","[{'ForeName': 'Zhi-Feng', 'Initials': 'ZF', 'LastName': 'Yao', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Department of Emergency Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Min-Na', 'Initials': 'MN', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jun-Bo', 'Initials': 'JB', 'LastName': 'Ge', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}]",Basic & clinical pharmacology & toxicology,['10.1111/bcpt.13501']
1854,32992190,Dual Antiplatelet Therapy Beyond 90 days in Symptomatic Intracranial Stenosis in the SAMMPRIS Trial.,"BACKGROUND


The safety and efficacy of dual antiplatelet use for symptomatic intracranial atherosclerosis beyond 90 days is unknown. Data from SAMMPRIS was used to determine if dual antiplatelet therapy (DAPT) beyond 90 days impacted the risk of ischemic stroke and hemorrhage.
METHODS


This post hoc exploratory analysis from SAMMPRIS included patients who did not have a primary endpoint within 90 days after enrollment (n = 397). Patients in both the aggressive medical management (AMM) and percutaneous transluminal angioplasty and stenting (PTAS) arms were included. Baseline features and outcomes during follow-up were compared between patients who remained on DAPT beyond 90 days (on clopidogrel) and patients who discontinued clopidogrel and remained on aspirin alone at 90 days (off clopidogrel) using Fisher's exact tests.
RESULTS


The stroke rate was numerically lower in the group on clopidogrel vs off clopidogrel among both the AMM alone arm (6.0% versus 10.8%, p = 0.31) and the PTAS arm (8.7% versus 9.8%; p = 0.82), but the difference was not significant. The major hemorrhage rates were numerically higher in the group on clopidogrel vs. off clopidogrel group among both the AMM alone arm (4.0% versus 2.5%; p = 0.67) and the PTAS arm (10.9% versus 3.5%; p = 0.08), but were not significant.
CONCLUSION


This exploratory analysis suggests that prolonged DAPT use may lower the risk of stroke in medically treated patients with intracranial stenosis but may increase the risk of major hemorrhage.",2020,"The major hemorrhage rates were numerically higher in the group on clopidogrel vs. off clopidogrel group among both the AMM alone arm (4.0% versus 2.5%; p = 0.67) and the PTAS arm (10.9% versus 3.5%; p = 0.08), but were not significant.
",['patients who did not have a primary endpoint within 90 days after enrollment (n\xa0=\xa0397'],"['aggressive medical management (AMM) and percutaneous transluminal angioplasty and stenting (PTAS', 'Dual Antiplatelet Therapy', 'clopidogrel', 'aspirin']","['stroke rate', 'major hemorrhage rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",397.0,0.0576875,"The major hemorrhage rates were numerically higher in the group on clopidogrel vs. off clopidogrel group among both the AMM alone arm (4.0% versus 2.5%; p = 0.67) and the PTAS arm (10.9% versus 3.5%; p = 0.08), but were not significant.
","[{'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Abdul Rahman', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: abdulara@musc.edu.'}, {'ForeName': 'Tanya N', 'Initials': 'TN', 'LastName': 'Turan', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: turan@musc.edu.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Cotsonis', 'Affiliation': 'Department of Biostatistics and Bioinformatics, 1518 Clifton Rd, Emory University Rollins School of Public Health, Atlanta 30322, GA, United States. Electronic address: gcotson@emory.edu.'}, {'ForeName': 'Eyad', 'Initials': 'E', 'LastName': 'Almallouhi', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: almallou@musc.edu.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Holmstedt', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: holmsted@musc.edu.'}, {'ForeName': 'Marc I', 'Initials': 'MI', 'LastName': 'Chimowitz', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: mchimow@musc.edu.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105254']
1855,32992206,Impact of a Pre-Discharge Education Session on Stroke Knowledge: a Randomized Trial.,"BACKGROUND AND PURPOSES


Stroke knowledge, awareness of risk factors and stroke warning symptoms is very poor among stroke survivors. We investigated whether a pre-discharge education intervention in the stroke unit could improve stroke knowledge in patients with TIA or minor stroke.
METHODS


We performed a prospective single-center, randomized controlled trial (2013-2016) in patients with TIA or minor stroke. The intervention consisted in an interactive group session focused on stroke education, within the stroke unit before hospital discharge. Primary outcome was the 3-month change in stroke knowledge score (SKS) from randomization. Secondary outcomes were the 12-month change in SKS, the number of risk factors and warning signs named, control of risk factors and self-reported adherence.
RESULTS


A total of 199 patients (mean [SD] age, 63.5 [12.4] years; 67 [33.7%] women) were randomized (99 in stroke education session). Intervention was associated with a greater improvement in SKS than in the control group (baseline-adjusted mean between-group difference, 1.6 point [95%CI, 1.4 to 1.9]; p=0.001). This difference was significantly maintained at 12 months. The number of risk factors and warning signs named were significantly increased in the intervention group at 3 months. Control of risk factors and self-reported adherence did not differ significantly between the two groups.
CONCLUSIONS


An interactive education session in the stroke unit significantly improved stroke knowledge at 3 months and 12 months in patients with TIA or minor stroke.",2020,"Intervention was associated with a greater improvement in SKS than in the control group (baseline-adjusted mean between-group difference, 1.6 point [95%CI, 1.4 to 1.9]; p=0.001).","['patients with TIA or minor stroke', '199 patients (mean [SD] age, 63.5 [12.4] years; 67 [33.7%] women']","['Pre-Discharge Education Session', 'pre-discharge education intervention']","['number of risk factors and warning signs named', 'SKS', '3-month change in stroke knowledge score (SKS', 'stroke knowledge', '12-month change in SKS, the number of risk factors and warning signs named, control of risk factors and self-reported adherence', 'Stroke Knowledge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",199.0,0.144626,"Intervention was associated with a greater improvement in SKS than in the control group (baseline-adjusted mean between-group difference, 1.6 point [95%CI, 1.4 to 1.9]; p=0.001).","[{'ForeName': 'Charline', 'Initials': 'C', 'LastName': 'Benoit', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France. Electronic address: charline.benoit@aphp.fr.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Lopez', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France.'}, {'ForeName': 'Murielle', 'Initials': 'M', 'LastName': 'Loiseau', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'Univ.Lille, CHU Lille, EA 2694-Santé Publique:Épidémiologie et Qualité des Soins, F-59000 Lille, France.'}, {'ForeName': 'Maeva', 'Initials': 'M', 'LastName': 'Kyheng', 'Affiliation': 'Univ.Lille, CHU Lille, EA 2694-Santé Publique:Épidémiologie et Qualité des Soins, F-59000 Lille, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Bourdain', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lapergue', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105272']
1856,32992268,Training with tarantulas: A randomized feasibility and acceptability study using experiential learning to enhance exposure therapy training.,"BACKGROUND


Although exposure is a key evidence-based intervention for anxiety, it is infrequently used in clinical settings. This study employed a novel training strategy, experiential learning, to improve exposure implementation. This study aimed to assess the feasibility and acceptability of experiential training and preliminary training effectiveness.
METHODS


Participants were 28 therapists who were randomized to (a) training-as-usual or (b) experiential training (training-as-usual plus a one-session treatment for fear of spiders). Workshops lasted one day and were followed by three months of weekly consultation.
RESULTS


Experiential training was viewed as feasible and acceptable. Participants, including those who were fearful of spiders, had a positive response to the training and reported it to be useful. There was a significant increase in the number of exposures used by therapists receiving experiential training compared to training-as-usual at 1-month follow-up.
CONCLUSIONS


A one-day training resulted in significant improvements in knowledge, attitudes toward exposure, and self-efficacy in using exposure. Preliminary findings suggest that experiential training resulted in greater use of exposure post-training compared to training-as-usual. Results provide evidence for the feasibility and acceptability of experiential training as a strategy to increase the use of evidence-based interventions.",2020,Preliminary findings suggest that experiential training resulted in greater use of exposure post-training compared to training-as-usual.,['Participants were 28 therapists who were randomized to (a'],"['training-as-usual or (b) experiential training (training-as-usual plus a one-session treatment for fear of spiders', 'experiential learning to enhance exposure therapy training', 'experiential training']","['knowledge, attitudes toward exposure, and self-efficacy', 'number of exposures']",[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392331', 'cui_str': 'Arachnophobia'}, {'cui': 'C0243012', 'cui_str': 'Active Learning'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0454267', 'cui_str': 'Number of exposures'}]",28.0,0.02074,Preliminary findings suggest that experiential training resulted in greater use of exposure post-training compared to training-as-usual.,"[{'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Frank', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA. Electronic address: hannah.frank@temple.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Becker-Haimes', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, 3rd Floor, Philadelphia, PA, 19104, USA; Hall-Mercer Community Mental Health Center, 245 S. 8th St., Philadelphia, PA, 19107, USA.'}, {'ForeName': 'Lara S', 'Initials': 'LS', 'LastName': 'Rifkin', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Norris', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Ollendick', 'Affiliation': 'Child Study Center, Virginia Polytechnic Institute and State University, 460 Turner St., Suite 207, Blacksburg, VA, 24060, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Olino', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Hilary E', 'Initials': 'HE', 'LastName': 'Kratz', 'Affiliation': 'Department of Psychology, La Salle University, 1900 W. Olney Ave., Philadelphia, PA, 19141, USA.'}, {'ForeName': 'Rinad S', 'Initials': 'RS', 'LastName': 'Beidas', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, 3rd Floor, Philadelphia, PA, 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Drive, Philadelphia, PA, 19104, USA; Penn Implementation Science Center at the Leonard David Institute of Health Economics (PISCE @LDI), 3641 Locust Walk, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Kendall', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102308']
1857,32976204,Effect of two different pre-operative exercise training regimens before colorectal surgery on functional capacity: A randomised controlled trial.,"BACKGROUND


Multimodal prehabilitation, including exercise training, nutritional therapy and anxiety reduction, has been shown to attenuate functional decline associated with surgery. Due to the growing interest in functional status as a targeted surgical outcome, a better understanding of the optimal prescription of exercise is critical.
OBJECTIVE


The objective is to compare peri-operative functional trajectory in response to two different exercise training protocols within a 4-week, supervised, multimodal prehabilitation programme.
DESIGN


This was a single blinded, single centre, randomised controlled study. Participants performed four assessments: at baseline, after prehabilitation (just before surgery), and at 1 and 2 months after surgery.
PATIENTS


Adult patients scheduled for elective resection of nonmetastatic colorectal cancer were included provided there were no absolute contraindications to exercise nor poor language comprehension.
INTERVENTION


Patients followed either high-intensity interval training (HIIT), or moderate intensity continuous training (MICT), as part of a 4-week multimodal prehabilitation programme. Both groups followed the same supervised resistance training, nutritional therapy and anxiety reduction interventions. All patients followed standardised peri-operative management.
MAIN OUTCOME MEASURE


Changes in oxygen consumption at anaerobic threshold, measured with sequential cardio-pulmonary exercise testing, were assessed and compared between groups.
RESULTS


Forty two patients were included in the primary analysis (HIIT n = 21 vs. MICT n = 21), with mean ± SD age 64.5 ± 11.2 years and 62% were men. At 2 months after surgery, 13/21 (62%) in HIIT and 11/21 (52%) in MICT attended the study visits. Both protocols significantly enhanced pre-operative functional capacity, with no difference between groups: mean (95% confidence interval) oxygen consumption at anaerobic threshold 1.97 (0.75 to 3.19) ml kg min in HIIT vs. 1.71 (0.56 to 2.85) in MICT, P = 0.753. At 2 months after surgery, the HIIT group showed a higher improvement in physical fitness: 2.36 (0.378 to 4.34) ml kg min, P = 0.021. No adverse events occurred during the intervention.
CONCLUSION


Both MICT and HIIT enhanced pre-operative functional capacity.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03361150.",2020,"At 2 months after surgery, the HIIT group showed a higher improvement in physical fitness: 2.36 (0.378 to 4.34) ","['Adult patients scheduled for elective resection of nonmetastatic colorectal cancer', 'Forty', 'two patients were included in the primary analysis (HIIT n\u200a=\u200a21 vs. MICT n\u200a=\u200a21), with mean\u200a±\u200aSD age 64.5\u200a±\u200a11.2 years and 62% were men']","['Patients followed either high-intensity interval training (HIIT), or moderate intensity continuous training (MICT', 'pre-operative exercise training regimens', 'supervised resistance training, nutritional therapy and anxiety reduction interventions']","['adverse events', 'oxygen consumption', 'physical fitness', 'pre-operative functional capacity', 'Changes in oxygen consumption at anaerobic threshold, measured with sequential cardio-pulmonary exercise testing', 'functional capacity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]",42.0,0.0783114,"At 2 months after surgery, the HIIT group showed a higher improvement in physical fitness: 2.36 (0.378 to 4.34) ","[{'ForeName': 'Enrico M', 'Initials': 'EM', 'LastName': 'Minnella', 'Affiliation': 'From the Department of Anesthesia, McGill University Health Centre, Montreal General Hospital, (EMM, VF, RA, CS-B, FC), Department of Kinesiology and Physical Education, McGill University, (VF, CS-B), Department of Surgery, (PC, BS, ASL) and Division of Geriatric Medicine, McGill University Health Centre, Montreal General Hospital, Montreal, Quebec, Canada (JAM).'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Ferreira', 'Affiliation': ''}, {'ForeName': 'Rashami', 'Initials': 'R', 'LastName': 'Awasthi', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Charlebois', 'Affiliation': ''}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Stein', 'Affiliation': ''}, {'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Liberman', 'Affiliation': ''}, {'ForeName': 'Celena', 'Initials': 'C', 'LastName': 'Scheede-Bergdahl', 'Affiliation': ''}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Morais', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001215']
1858,32977137,Therapeutic versus prophylactic anticoagulation for severe COVID-19: A randomized phase II clinical trial (HESACOVID).,"INTRODUCTION


Coronavirus disease 2019 (COVID-19) causes a hypercoagulable state. Several autopsy studies have found microthrombi in pulmonary circulation.
METHODS


In this randomized, open-label, phase II study, we randomized COVID-19 patients requiring mechanical ventilation to receive either therapeutic enoxaparin or the standard anticoagulant thromboprophylaxis. We evaluated the gas exchange over time through the ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, 7, and 14 days after randomization, the time until successful liberation from mechanical ventilation, and the ventilator-free days.
RESULTS


Ten patients were assigned to the therapeutic enoxaparin and ten patients to prophylactic anticoagulation. There was a statistically significant increase in the PaO2/FiO2 ratio over time in the therapeutic group (163 [95% confidence interval - CI 133-193] at baseline, 209 [95% CI 171-247] after 7 days, and 261 [95% CI 230-293] after 14 days), p = 0.0004. In contrast, we did not observe this improvement over time in the prophylactic group (184 [95% CI 146-222] at baseline, 168 [95% CI 142-195] after 7 days, and 195 [95% CI 128-262] after 14 days), p = 0.487. Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = 0.031 and more ventilator-free days (15 days [interquartile range IQR 6-16] versus 0 days [IQR 0-11]), p = 0.028 when compared to the prophylactic group.
CONCLUSION


Therapeutic enoxaparin improves gas exchange and decreases the need for mechanical ventilation in severe COVID-19.
TRIAL REGISTRATION


REBEC RBR-949z6v.",2020,"Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = ","['COVID-19 patients requiring mechanical ventilation to receive either', 'severe COVID-19']","['Therapeutic versus prophylactic anticoagulation', 'enoxaparin', 'prophylactic anticoagulation', 'therapeutic enoxaparin', 'therapeutic enoxaparin or the standard anticoagulant thromboprophylaxis']","['PaO2/FiO2 ratio', 'higher ratio of successful liberation from mechanical ventilation', 'gas exchange over time through the ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}]",10.0,0.230806,"Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = ","[{'ForeName': 'Anna Cristina Bertoldi', 'Initials': 'ACB', 'LastName': 'Lemos', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Douglas Alexandre', 'Initials': 'DA', 'LastName': 'do Espírito Santo', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Maísa Cabetti', 'Initials': 'MC', 'LastName': 'Salvetti', 'Affiliation': 'Hospital Estadual de Américo Brasiliense, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Renato Noffs', 'Initials': 'RN', 'LastName': 'Gilio', 'Affiliation': 'Hospital Estadual de Américo Brasiliense, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Lucas Barbosa', 'Initials': 'LB', 'LastName': 'Agra', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pazin-Filho', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Carlos Henrique', 'Initials': 'CH', 'LastName': 'Miranda', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil. Electronic address: chmiranda@fmrp.usp.br.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.026']
1859,32977202,The differential impact of viewing fitspiration and thinspiration images on men's body image concerns: An experimental ecological momentary assessment study.,"To date, little is known about the impact of fitspiration and thinspiration exposure on men, as previous studies on these social media trends were primarily conducted on women. Male participants (n = 223) completed baseline measures of trait body image, then used a smartphone application to complete up to six state-based assessments daily for seven days. In each assessment, participants were randomly assigned to one of three image conditions (fitspiration, thinspiration, or neutral). Before and after viewing each image, they reported state body fat dissatisfaction, muscularity dissatisfaction, negative mood, and urge to engage in behaviours to reduce body fat and increase muscularity. Multi-level analyses revealed that compared to viewing neutral images, viewing fitspiration images increased men's body dissatisfaction, whereas viewing thinspiration images decreased body dissatisfaction. Viewing either fit- or thinspiration images also led to lower mood and greater urges to increase muscularity, whereas only fitspiration images increased urges to reduce body fat. Men with greater baseline muscularity dissatisfaction and higher appearance comparison were most vulnerable to muscularity dissatisfaction after viewing fitspiration images. Findings suggest the importance of limiting exposure to fitspiration imagery and implementing social media literacy programmes for men and well as women.",2020,"Viewing either fit- or thinspiration images also led to lower mood and greater urges to increase muscularity, whereas only fitspiration images increased urges to reduce body fat.","['men and well as women', 'Male participants (n = 223', ""men's body image concerns""]",['viewing fitspiration and thinspiration images'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",[],223.0,0.019817,"Viewing either fit- or thinspiration images also led to lower mood and greater urges to increase muscularity, whereas only fitspiration images increased urges to reduce body fat.","[{'ForeName': 'Zhi Wei', 'Initials': 'ZW', 'LastName': 'Yee', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: zhiwei@student.unimelb.edu.au.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Griffiths', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: scott.griffiths@unimelb.edu.au.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Fuller-Tyszkiewicz', 'Affiliation': 'Centre for Social and Early Emotional Development, School of Psychology, Deakin University, Burwood, VIC, 3125, Australia; School of Psychology, Deakin University, Burwood, VIC, 3125, Australia. Electronic address: matthew.fuller.tyszkiewicz@deakin.edu.au.'}, {'ForeName': 'Khandis', 'Initials': 'K', 'LastName': 'Blake', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: khandis.blake@unimelb.edu.au.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Richardson', 'Affiliation': 'School of Psychology, Deakin University, Burwood, VIC, 3125, Australia. Electronic address: Ben.Richardson@nousgroup.com.au.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Krug', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: Isabel.krug@unimelb.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.08.008']
1860,32977212,Behavioral and electrophysiological effects of network-based frontoparietal tDCS in patients with severe brain injury: A randomized controlled trial.,"BACKGROUND


Transcranial direct current stimulation (tDCS) may promote the recovery of severely brain-injured patients with disorders of consciousness (DOC). Prior tDCS studies targeted single brain regions rather than brain networks critical for consciousness recovery.
OBJECTIVE


Investigate the behavioral and electrophysiological effects of multifocal tDCS applied over the frontoparietal external awareness network in patients with chronic acquired DOC.
METHODS


Forty-six patients were included in this randomized double-blind sham-controlled crossover trial (median [interquartile range]: 46 [35 - 59] years old; 12 [5 - 47] months post injury; 17 unresponsive wakefulness syndrome, 23 minimally conscious state (MCS) and 6 emerged from the MCS). Multifocal tDCS was applied for 20 min using 4 anodes and 4 cathodes with 1 mA per electrode. Coma Recovery Scale-Revised (CRS-R) assessment and 10 min of resting state electroencephalogram (EEG) recordings were acquired before and after the active and sham sessions.
RESULTS


At the group level, there was no tDCS behavioral treatment effect. However, following active tDCS, the EEG complexity significantly increased in low frequency bands (1-8 Hz). CRS-R total score improvement was associated with decreased baseline complexity in those bands. At the individual level, after active tDCS, new behaviors consistent with conscious awareness emerged in 5 patients. Conversely, 3 patients lost behaviors consistent with conscious awareness.
CONCLUSION


The behavioral effect of multifocal frontoparietal tDCS varies across patients with DOC. Electrophysiological changes were observed in low frequency bands but not translated into behavioral changes at the group level.",2020,"At the group level, there was no tDCS behavioral treatment effect.","['severely brain-injured patients with disorders of consciousness (DOC', 'patients with severe brain injury', 'Forty-six patients', 'patients with chronic acquired DOC', 'patients with DOC']","['multifocal tDCS', 'network-based frontoparietal tDCS', 'Transcranial direct current stimulation (tDCS', 'minimally conscious state (MCS) and 6 emerged from the MCS']","['EEG complexity', 'CRS-R total score improvement', 'Electrophysiological changes', 'Coma Recovery Scale-Revised (CRS-R) assessment and 10\xa0min of resting state electroencephalogram (EEG) recordings']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009792', 'cui_str': 'Consciousness Disorders'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}]","[{'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0751699', 'cui_str': 'Minimally conscious state'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}]",46.0,0.240193,"At the group level, there was no tDCS behavioral treatment effect.","[{'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Martens', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium. Electronic address: geraldine.martens@uliege.be.""}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Kroupi', 'Affiliation': 'Starlab Barcelona SL, Barcelona, Spain.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Bodien', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA; Laboratory for Neuroimaging in Coma and Consciousness, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Frasso', 'Affiliation': 'Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium.'}, {'ForeName': 'Jitka', 'Initials': 'J', 'LastName': 'Annen', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Cassol', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Barra', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Martial', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Gosseries', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Lejeune', 'Affiliation': 'Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre Hospitalier Neurologique William Lennox, Saint-Luc University Clinics, Université Catholique de Louvain, Belgium.'}, {'ForeName': 'Aureli', 'Initials': 'A', 'LastName': 'Soria-Frisch', 'Affiliation': 'Starlab Barcelona SL, Barcelona, Spain.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Ruffini', 'Affiliation': 'Starlab Barcelona SL, Barcelona, Spain.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Laureys', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Thibaut', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium; Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, USA.""}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102426']
1861,32979708,"The comparison of the effect of soybean and fish oil on supplementation on menopausal symptoms in postmenopausal women: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


The effect of soybean and omega-3 fatty acid supplementation on menopausal symptoms in postmenopausal women was investigated.
MATERIALS AND METHODS


In a randomized, double-blind, placebo-controlled trial postmenopausal women were randomly given either soybean (Soygan 500 mg capsule; n = 60), or omega-3 fatty acids (Omega-rex 1000 mg soft gel; n = 60), or placebo (n = 60) daily for 12 weeks. The primary outcome was a change on the menopause rating scale score (MRS), while the secondary outcome was any adverse symptoms and effect was effect of soybean or omega-3 fatty acid supplements on the blood lipids and thyroid hormone.
RESULTS


Based on the results of post-hoc in terms of overall MRS score there was a significant difference between the control and Soygan (p < 0.001) and Omega-rex groups (p = 0.03); however, there was no significant difference between the two intervention groups (p = 0.86). Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
CONCLUSION


Soygan and Omega-rex reduced the MRS score and improved menopausal symptoms in postmenopausal women.",2020,"Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
","['controlled trial postmenopausal women', 'postmenopausal women']","['soybean and omega-3 fatty acid supplementation', 'Omega-rex 1000\xa0mg soft gel; n\xa0=\xa060), or placebo', 'soybean or omega-3 fatty acid supplements', 'placebo', 'soybean and fish oil on supplementation', 'soybean (Soygan 500\xa0mg capsule; n\xa0=\xa060), or omega-3 fatty acids ']","['MRS score and improved menopausal symptoms', 'blood lipids and thyroid hormone', 'overall MRS score', 'menopausal symptoms', 'menopause rating scale score (MRS']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0324505', 'cui_str': 'Rex cat breed'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.663549,"Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
","[{'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Purzand', 'Affiliation': 'School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Rokhgireh', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran. Electronic address: s.rokhgireh@gmail.com.'}, {'ForeName': 'Mansoore', 'Initials': 'M', 'LastName': 'Shabani Zanjani', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Eshraghi', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Mahdiss', 'Initials': 'M', 'LastName': 'Mohamadianamiri', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Esmailzadeh', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Alkatout', 'Affiliation': 'Department of Obstetrics and Gynecology, Kiel School of Gynaecological Endoscopy, University Hospital Schleswig Holstein, Campus Kiel, Arnold-Heller-Str. 3, Haus C, 24105, Kiel, Germany.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Gitas', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of Schleswig Holstein, Luebeck, Germany.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Allahqoli', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101239']
1862,32985080,"Predictors of receiving a diagnosis, referral and treatment of depression in people on antiretroviral therapy in South African primary care: a secondary analysis of data from a randomised trial.","OBJECTIVE


To describe the receipt of a diagnosis, referral and treatment for depression in people receiving antiretroviral therapy (ART), with depressive symptoms and attending primary care clinics in South Africa, and investigate factors associated with receiving these components of care.
METHODS


This is a secondary analysis of data from a randomised controlled trial of an intervention intended to improve detection and treatment of depression in primary care patients receiving ART. In this analysis, we combined cross-sectional and longitudinal data from the intervention and control arms. Using regression models and adjusting for intra-cluster correlation of outcomes, we investigated associations between socioeconomic characteristics, depressive symptoms, stress, disability and stigma, and receipt of a diagnosis, referral and treatment for depression.
RESULTS


Of 2002 participants enrolled, 18% reported a previous diagnosis of depression by a healthcare worker and 10% reported having received counselling from a specialist mental health worker. Diagnosis, referral and counselling during the follow-up period were appropriately targeted, being independently more frequent in participants with higher enrolment scores for depressive symptoms, stress or disability. Participants with higher stigma scores at enrolment were independently less likely to receive counselling. Severe socio-economic deprivation was common but was not associated with treatment.
CONCLUSION


While the receipt of a diagnosis, referral and treatment for depression were uncommon, they seemed to be appropriately targeted. Socio-economic deprivation was not associated with treatment.",2020,Participants with higher stigma scores at enrolment were independently less likely to receive counselling.,"['people on antiretroviral therapy in South African primary care', '2002 participants enrolled, 18% reported a previous diagnosis of depression by a healthcare worker and 10% reported having received counselling from a specialist mental health worker', 'people receiving antiretroviral therapy (ART), with depressive symptoms and attending primary care clinics in South Africa', 'primary care patients receiving ART']",[],"['sociodemographic characteristics, depressive symptoms, stress, disability, and stigma, and receipt of a diagnosis, referral and treatment for depression', 'Socioeconomic deprivation', 'depressive symptoms, stress or disability', 'Severe socioeconomic deprivation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",2002.0,0.292692,Participants with higher stigma scores at enrolment were independently less likely to receive counselling.,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zani', 'Affiliation': 'Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fairall', 'Affiliation': 'Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Petersen', 'Affiliation': 'Centre for Rural Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Folb', 'Affiliation': 'Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bhana', 'Affiliation': 'Centre for Rural Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Thornicroft', 'Affiliation': ""Centre for Global Mental Health, King's College London, London, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hanass-Hancock', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': ""Centre for Global Mental Health, King's College London, London, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bachmann', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13495']
1863,32985341,"Patient-Reported Outcomes from a 1-Year, Real-World, Head-to-Head Comparison of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine.","INTRODUCTION/OBJECTIVE


Chronic migraine (CM) is associated with impaired health-related quality of life and substantial socioeconomic burden, but many people with CM are underdiagnosed and do not receive appropriate preventive treatment. OnabotulinumtoxinA and topiramate have demonstrated  efficacy  (treatment benefit under ideal conditions) for the prevention of headaches in people with CM in clinical trials, but real-world studies suggest markedly different clinical  effectiveness  (treatment benefit based on a blend of efficacy and tolerability). This study sought to evaluate patient-reported outcomes (PROs) of onabotulinumtoxinA versus topiramate immediate release for people with CM.
METHODS


FORWARD was a prospective, multicenter, randomized, parallel-group, open-label, phase 4 study comparing onabotulinumtoxinA 155 U every 12 weeks with topiramate 50 to 100 mg/day for ≤36 weeks in people with CM. PROs measured included the Headache Impact Test (HIT-6), 9-item Patient Health Questionnaire Quick Depression Assessment (PHQ-9), Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP), and Functional Impact of Migraine Questionnaire (FIMQ).
RESULTS


A total of 282 patients were randomized and treated with onabotulinumtoxinA (n = 140) or topiramate (n = 142). From baseline to week 30, mean HIT-6 test scores improved significantly in patients taking onabotulinumtoxinA compared with topiramate ( P  < .001). Improvements in depression over time were observed via larger changes in PHQ-9 scores with onabotulinumtoxinA than topiramate ( P  < .001). Work productivity assessed via WPAI:SHP scores revealed significant improvements with onabotulinumtoxinA versus topiramate in Work Productivity Loss ( P  = .024) and Activity Impairment ( P  < .001) domains. Results from the FIMQ also revealed a larger reduction from baseline with onabotulinumtoxinA vs topiramate ( P  < .0001).
CONCLUSION


OnabotulinumtoxinA treatment had more favorable real-world effectiveness than topiramate on depression, headache impact, functioning and daily living, activity, and work productivity. The overall study results suggest that the beneficial effects on a range of PROs are the result of improved effectiveness when onabotulinumtoxinA is used as preventive treatment for CM.
TRIAL REGISTRATION: CLINICALTRIALS.GOV


NCT02191579; https://clinicaltrials.gov/ct2/show/NCT02191579.",2020,SHP scores revealed significant improvements with onabotulinumtoxinA versus topiramate in Work Productivity Loss ( P  = .024) and Activity Impairment ( P  < .001) domains.,"['282 patients', 'Adults With Chronic Migraine', 'people with CM']","['topiramate', 'onabotulinumtoxinA', 'OnabotulinumtoxinA and Topiramate', 'OnabotulinumtoxinA and topiramate', 'onabotulinumtoxinA versus topiramate', 'OnabotulinumtoxinA', 'onabotulinumtoxinA vs topiramate']","['depression, headache impact, functioning and daily living, activity, and work productivity', 'SHP scores', 'Activity Impairment', 'Work Productivity Loss', 'Work productivity assessed via WPAI', 'Headache Impact Test (HIT-6), 9-item Patient Health Questionnaire Quick Depression Assessment (PHQ-9), Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP), and Functional Impact of Migraine Questionnaire (FIMQ', 'PHQ-9 scores', 'mean HIT-6 test scores']","[{'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C1335142', 'cui_str': 'NR0B2 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",282.0,0.144939,SHP scores revealed significant improvements with onabotulinumtoxinA versus topiramate in Work Productivity Loss ( P  = .024) and Activity Impairment ( P  < .001) domains.,"[{'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Blumenfeld', 'Affiliation': 'Headache Center of Southern California, The Neurology Center, Carlsbad, CA, USA.'}, {'ForeName': 'Atul T', 'Initials': 'AT', 'LastName': 'Patel', 'Affiliation': 'Kansas City Bone and Joint Clinic, Overland Park, KS, USA.'}, {'ForeName': 'Ira M', 'Initials': 'IM', 'LastName': 'Turner', 'Affiliation': 'The Center for Headache Care and Research, Island Neurological Associates, Plainview, NY, USA.'}, {'ForeName': 'Kathleen B', 'Initials': 'KB', 'LastName': 'Mullin', 'Affiliation': 'Montefiore Headache Center, Bronx, NY, USA.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Manack Adams', 'Affiliation': 'Allergan, an AbbVie Company, Irvine, CA, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Rothrock', 'Affiliation': 'George Washington University School of Medicine, Washington, DC, USA.'}]",Journal of primary care & community health,['10.1177/2150132720959936']
1864,32979939,"High-dose and low-dose varenicline for smoking cessation in adolescents: a randomised, placebo-controlled trial.","BACKGROUND


Although cigarette smoking typically begins in adolescence, evidence for successful pharmacological smoking cessation interventions for this population is scarce. In adult smokers, varenicline is the most effective single pharmacotherapy. The aim of this study was to assess the efficacy and tolerability of varenicline for smoking cessation in adolescents.
METHODS


We did a randomised, placebo-controlled trial with adolescent smokers aged 12-19 years who were seeking treatment to quit at 57 outpatient centres (in the USA, Russia, South Korea, Taiwan, Canada, and Georgia). Participants were randomly assigned (1:1:1) to receive 12 weeks of high-dose varenicline (1 mg twice daily; 0·5 mg twice daily if bodyweight ≤55 kg), low-dose varenicline (0·5 mg twice daily; 0·5 mg once daily if bodyweight ≤55 kg), or placebo, then followed up for 40 additional weeks. At all visits, participants received brief, developmentally tailored smoking cessation counselling (<10 min per session) delivered by a trained counsellor. The primary efficacy outcome was continuous abstinence from weeks 9 to 12, measured via a Nicotine Use Inventory and confirmed by urine cotinine testing. The primary tolerability outcome was frequency of treatment-emergent adverse events, including neuropsychiatric adverse events, occurring after the first dose and within 30 days of the last dose of study medication. This trial is registered with ClinicalTrials.gov, NCT01312909.
FINDINGS


Between April 26, 2011, and Jan 18, 2018, 312 participants were enrolled and completed participation in the study: 109 in the high-dose varenicline group, 103 in the low-dose varenicline group, and 100 in the placebo group. The continuous abstinence rates from week 9 to 12 were 20% (22 of 109) in the high-dose varenicline group, 27% (28 of 103) in the low-dose varenicline group, and 18% (18 of 100) in the placebo group. Abstinence rates between high-dose varenicline and placebo groups (odds ratio [OR] 1·18 [95% CI 0·59-2·37]; p=0·63) and between low-dose varenicline and placebo groups (1·73 [0·88-3·39]; p=0·11) did not differ significantly. Treatment-emergent adverse events occurred in 65 (60%) of 108 participants in the high-dose group, 53 (53%) of 100 in the low-dose group, and 52 (53%) of 99 in the placebo group, and most were rated as mild. Neuropsychiatric treatment-emergent adverse events occurred in 18 (17%) of 108 participants in the high-dose group, 11 (11%) of 100 in the low-dose group, and 12 (12%) of 99 in the placebo group, and none was rated as severe.
INTERPRETATION


This trial did not show an advantage in abstinence with varenicline compared with placebo among adolescent smokers. The rates of treatment-emergent adverse events were similar to those in previous trials of adult smokers, raising no new tolerability signals. These findings do not support the use of varenicline as a first-line pharmacotherapy for smoking cessation in adolescents.
FUNDING


Pfizer.",2020,"Neuropsychiatric treatment-emergent adverse events occurred in 18 (17%) of 108 participants in the high-dose group, 11 (11%) of 100 in the low-dose group, and 12 (12%) of 99 in the placebo group, and none was rated as severe.
","['adolescent smokers', 'adolescents', 'adolescent smokers aged 12-19 years who were seeking treatment to quit at 57 outpatient centres (in the USA, Russia, South Korea, Taiwan, Canada, and Georgia', 'Between April 26, 2011, and Jan 18, 2018, 312 participants were enrolled and completed participation in the study: 109 in the high-dose varenicline group, 103 in the low-dose varenicline group, and 100 in the placebo group']","['placebo', 'High-dose and low-dose varenicline', 'varenicline', 'tailored smoking cessation counselling']","['continuous abstinence from weeks 9 to 12, measured via a Nicotine Use Inventory and confirmed by urine cotinine testing', 'Abstinence rates', 'rates of treatment-emergent adverse events', 'Treatment-emergent adverse events', 'severe', 'continuous abstinence rates', 'frequency of treatment-emergent adverse events, including neuropsychiatric adverse events', 'efficacy and tolerability', 'Neuropsychiatric treatment-emergent adverse events']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0017452', 'cui_str': 'Georgia state'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0303400', 'cui_str': 'Indium-109'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1697737', 'cui_str': 'Urine cotinine test'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",312.0,0.620913,"Neuropsychiatric treatment-emergent adverse events occurred in 18 (17%) of 108 participants in the high-dose group, 11 (11%) of 100 in the low-dose group, and 12 (12%) of 99 in the placebo group, and none was rated as severe.
","[{'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA. Electronic address: graykm@musc.edu.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Rubinstein', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'DuBrava', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Ann R', 'Initials': 'AR', 'LastName': 'Holstein', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Samuels', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'McRae', 'Affiliation': 'Pfizer, New York, NY, USA.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30243-1']
1865,32980608,Interprofessional simulation-based training in gynecologic oncology palliative care for students in the healthcare profession: A comparative randomized controlled trial.,"BACKGROUND


Preprofessional palliative care education may be inadequate, leaving a gap in health professional students' knowledge and understanding of managing patients with gynecologic cancer and their families. Interprofessional simulation-based training may be useful in helping health professional students gain the necessary skills required for palliative care.
OBJECTIVE


This study aimed to determine the effectiveness of different simulation methods used for interprofessional training on gynecologic oncology palliative care knowledge, interdisciplinary education perceptions, and teamwork attitudes of health professional students and to compare these methods.
DESIGN


A comparative randomized controlled trial was conducted with a pre-test and two post-tests.
SETTINGS


This study was conducted at a university in Ankara, Turkey, in 2016-2017.
PARTICIPANTS


A convenience sample of 84 interprofessional students (nursing, medical, nutrition-dietician, and social work) was used in the study.
METHODS


Students were stratified by their profession and randomized by four blocks into high-fidelity simulation, hybrid simulation, and a control group. Data were collected using a semi-structured questionnaire form, palliative care knowledge test, interdisciplinary education perception scale, and teamwork attitudes questionnaire.
RESULTS


The high-fidelity simulation and hybrid simulation groups improved their palliative care knowledge, interdisciplinary education perception, and teamwork attitudes from pre-test to first and second post-tests compared to the control group.
CONCLUSION


The introduction of high-fidelity simulation and hybrid simulation or hybrid simulation-based interprofessional training in undergraduate education can increase students' palliative care knowledge, interdisciplinary education perception, and teamwork attitudes. Training programs that are used together with high-fidelity simulation and hybrid simulation applications in interdisciplinary training should be integrated into the undergraduate curricula of future cooperating health professions.",2020,"The high-fidelity simulation and hybrid simulation groups improved their palliative care knowledge, interdisciplinary education perception, and teamwork attitudes from pre-test to first and second post-tests compared to the control group.
","['health professional students', 'A convenience sample of 84 interprofessional students (nursing, medical, nutrition-dietician, and social work) was used in the study', 'patients with gynecologic cancer and their families', 'Students were stratified by their profession', 'students in the healthcare profession', 'university in Ankara, Turkey, in 2016-2017']","['interprofessional training', 'Interprofessional simulation-based training', 'hybrid simulation-based interprofessional training']","['palliative care knowledge, interdisciplinary education perception, and teamwork attitudes']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",84.0,0.0506668,"The high-fidelity simulation and hybrid simulation groups improved their palliative care knowledge, interdisciplinary education perception, and teamwork attitudes from pre-test to first and second post-tests compared to the control group.
","[{'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Uslu-Sahan', 'Affiliation': 'Department of Obstetrics and Gynecologic Nursing, Faculty of Nursing, Hacettepe University, Ankara, Turkey. Electronic address: fatma.uslu@hacettepe.edu.tr.'}, {'ForeName': 'Fusun', 'Initials': 'F', 'LastName': 'Terzioglu', 'Affiliation': 'Faculty of Health Science, Atilim University, Ankara, Turkey.'}]",Nurse education today,['10.1016/j.nedt.2020.104588']
1866,32980623,Successful implementation of text-based blood pressure monitoring for postpartum hypertension.,"OBJECTIVES


A clinical trial showed postpartum text-based blood pressure (BP) monitoring is effective in meeting clinical guidelines and reduces racial disparities in postpartum hypertension care. Our objective was to compare clinical outcomes to those from a clinical trial after implementation of the program in a second hospital within our hospital system.
STUDY DESIGN


Comparison of women randomized to text-based BP monitoring in a clinical trial compared to an implementation cohort clinically enrolled in text-based BP monitoring. BP outcomes and postpartum visit were compared in bivariate and multivariable analyses.
MAIN OUTCOME MEASURES


BP ascertainment was defined as at least 1 BP texted during the 10 days of monitoring. American College of Obstetricians and Gynecologists (ACOG) recommendation was defined as BP sent on postpartum day 3-4 and again day 7-10.
RESULTS


The implementation cohort had 333 women compared to 103 in the trial cohort. The implementation cohort was older (p < 0.001), and more likely to be non-Black race (p < 0.001), married (<0.001), and have commercial insurance (<0.001). BP ascertainment (95.5% vs. 92.2%, adjusted OR 1.41, [95% CI 0.55, 3.58]) and proportion meeting ACOG recommendations (84.7% vs. 81.6%, adjusted OR 0.89 [95% CI 0.48, 1.64]) were similar between groups. There were no differences in BP ascertainment among Black and non-Black women in the trial or implementation cohort.
CONCLUSIONS


Text-based BP monitoring performed similarly in an implementation cohort compared to the trial participants. This program is scalable to manage postpartum hypertension and reduce racial disparities in postpartum care in women with hypertensive disorders of pregnancy.",2020,"The implementation cohort was older (p < 0.001), and more likely to be non-Black race (p < 0.001), married (<0.001), and have commercial insurance (<0.001).","['postpartum hypertension', 'women with hypertensive disorders of pregnancy', '333 women compared to 103 in the trial cohort', 'American College of Obstetricians and Gynecologists (ACOG']","['text-based BP monitoring', 'text-based blood pressure monitoring', 'postpartum text-based blood pressure (BP) monitoring']","['BP ascertainment', 'proportion meeting ACOG recommendations', 'BP outcomes and postpartum visit']","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0586884', 'cui_str': 'Obstetrician and gynecologist'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]",,0.173943,"The implementation cohort was older (p < 0.001), and more likely to be non-Black race (p < 0.001), married (<0.001), and have commercial insurance (<0.001).","[{'ForeName': 'Jourdan E', 'Initials': 'JE', 'LastName': 'Triebwasser', 'Affiliation': 'Department of Obstetrics and Gynecology, Maternal and Child Health Research Center University of Pennsylvania Perelman School of Medicine, 421 Curie Boulevard, 1353 Biomedical Research Bldg. II/III, Philadelphia, PA 19104, USA; Department of Obstetrics and Gynecology, Pennsylvania Hospital University of Pennsylvania Perelman School of Medicine, 800 Spruce St. 2 Pine East, Philadelphia, PA 19107, USA. Electronic address: jourdan.triebwasser@pennmedicine.upenn.edu.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Janssen', 'Affiliation': 'Department of Obstetrics and Gynecology, Pennsylvania Hospital University of Pennsylvania Perelman School of Medicine, 800 Spruce St. 2 Pine East, Philadelphia, PA 19107, USA. Electronic address: matthew.janssen@pennmedicine.upenn.edu.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Hirshberg', 'Affiliation': 'Department of Obstetrics and Gynecology, Maternal and Child Health Research Center University of Pennsylvania Perelman School of Medicine, 421 Curie Boulevard, 1353 Biomedical Research Bldg. II/III, Philadelphia, PA 19104, USA. Electronic address: adi.hirshberg@pennmedicine.upenn.edu.'}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': 'Department of Obstetrics and Gynecology, Maternal and Child Health Research Center University of Pennsylvania Perelman School of Medicine, 421 Curie Boulevard, 1353 Biomedical Research Bldg. II/III, Philadelphia, PA 19104, USA. Electronic address: ssrinivas@pennmedicine.upenn.edu.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.09.001']
1867,32980656,Effectiveness of the Super Skills for Life programme in enhancing the emotional wellbeing of children and adolescents in residential care institutions in a low- and middle-income country: A randomised waitlist-controlled trial.,"BACKGROUND


The present study examined the effectiveness of a transdiagnostic prevention programme, Super Skills for Life (SSL), among children and adolescents with emotional problems in residential care institutions (RCIs) in the low- and middle-income country of Mauritius using a randomised waitlist-controlled trial (RCT). SSL is based on the principles of cognitive behavioural therapy, behavioural activation, social skills training, and uses video-feedback and cognitive preparation as part of the treatment.
METHODS


The RCT involved 100 children and adolescents aged 9 to 14 years, from six RCIs, randomly allocated to either an SSL intervention group (IG) or a waitlist-control (WLC) group. A set of questionnaires measuring internalising and externalising problems, emotion regulation and self-esteem, and experimental tasks measuring attentional bias and inhibitory control, were completed at baseline, post-intervention and 3-month follow-up. Participants also completed a 2-min video speech task during the first and final sessions of the SSL intervention.
RESULTS


Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up. These findings were not replicated among children in the WLC.
LIMITATIONS


The small sample size and lack of an active control group were the major limitations of this study.
CONCLUSIONS


This study provides evidence for the effectiveness of a transdiagnostic prevention programme for emotional problems in RCIs in a low- and middle-income country.",2020,"RESULTS


Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up.","['children and adolescents with emotional problems in residential care institutions (RCIs) in the low- and middle-income country of Mauritius', 'children and adolescents in residential care institutions in a low- and middle-income country', 'emotional problems in RCIs in a low- and middle-income country', '100 children and adolescents aged 9 to 14 years, from six RCIs']","['transdiagnostic prevention programme', 'SSL intervention group (IG) or a waitlist-control (WLC', 'Super Skills for Life programme', 'transdiagnostic prevention programme, Super Skills for Life (SSL', 'SSL']","['emotional wellbeing', 'maladaptive emotion regulation strategies', 'internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control', 'questionnaires measuring internalising and externalising problems, emotion regulation and self-esteem, and experimental tasks measuring attentional bias and inhibitory control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0024944', 'cui_str': 'Mauritius'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}]",100.0,0.0681738,"RESULTS


Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up.","[{'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Ramdhonee-Dowlot', 'Affiliation': 'Department of Psychology, University of Roehampton, UK. Electronic address: ramdhonk@roehampton.ac.uk.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Balloo', 'Affiliation': 'University of Surrey, UK.'}, {'ForeName': 'Cecilia A', 'Initials': 'CA', 'LastName': 'Essau', 'Affiliation': 'Department of Psychology, University of Roehampton, UK.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.053']
1868,32989836,An evaluation of systematized phonics on reading proficiency in Swedish second grade poor readers: Effects on pseudoword and sight word reading skills.,"The aim of the present study was to evaluate the effect of systematized phonics on word reading in Swedish second grade poor readers. Forty-nine children who performed at or below the 25th percentile on pseudoword reading and/or sight word reading at the beginning of second grade participated in the study. The study had a cross-over design exploring within-and between-group effects of two different conditions: systematized phonics and classroom instruction. Overall, systematized phonics proved more effective than classroom instruction. At pre-intervention, no child performed above the 30th percentile in pseudoword reading or sight word reading. At post-intervention, corresponding numbers were 69% for pseudoword reading and 35% for sight word reading. Implications for a policy change in Sweden towards mandatory systematized phonics in primary school are discussed.",2020,"At pre-intervention, no child performed above the 30th percentile in pseudoword reading or sight word reading.","['Forty-nine children who performed at or below the 25th percentile on pseudoword reading', 'Swedish second grade poor readers']","['systematized phonics and classroom instruction', 'systematized phonics', 'pseudoword and sight word reading skills']",['pseudoword reading or sight word reading'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0857754', 'cui_str': 'Poor reader'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]",49.0,0.0179629,"At pre-intervention, no child performed above the 30th percentile in pseudoword reading or sight word reading.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Levlin', 'Affiliation': 'Department of Language Studies, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Nakeva von Mentzer', 'Affiliation': 'School of Health Sciences, Örebro University, Örebro, Sweden.'}]","Dyslexia (Chichester, England)",['10.1002/dys.1669']
1869,32987346,The effects of McConnell patellofemoral joint and tibial internal rotation limitation taping techniques in people with Patellofemoral pain syndrome.,"BACKGROUND


Taping is frequently used as part of the multi-modal management for patellofemoral pain syndrome (PFPS). McConnell Patellofemoral Joint Taping (PFJT) and Tibial Internal Rotation Limitation Taping (TIRLT) are proposed to be useful adjuncts to the management of PFPS. However, it is unclear if TIRLT offers similar benefits to PFJT, and its effect on pain and lower limb kinematics have not been investigated previously.
RESEARCH QUESTION


What are the effects of TIRLT, PFJT and no taping on perceived pain and lower limb kinematics during a lunge and single leg squat (SLS) in people with PFPS?
METHODS


This cross-sectional study compared the effects of TIRLT, PFJT and no taping, on knee pain and lower limb kinematics during two pain-provoking movements in people with PFPS. Participants with PFPS (n = 23) performed a lunge and SLS under three randomised conditions: TIRLT, PFJT and no taping. The Codamotion system captured and analysed lower limb kinematic data in the sagittal, transverse and coronal planes. Peak knee pain intensity during the movement was assessed using the Numerical Rating Scale (NRS).
RESULTS


Participants reported significantly less pain with the TIRLT and PFJT techniques compared with no tape during the lunge (p = 0.005 and p = 0.011, respectively) and SLS (p= 0.002 and p = 0.001, respectively). There was no evidence of altered lower limb kinematics accompanying pain reductions with either taping technique.
SIGNIFICANCE


Both forms of taping may be useful adjuncts as the short-term benefit of pain relief may enable participation in more active forms of rehabilitation.",2020,"RESULTS


Participants reported significantly less pain with the TIRLT and PFJT techniques compared with no tape during the lunge (p = 0.005 and p = 0.011, respectively) and SLS (p= 0.002 and p = 0.001, respectively).","['people with PFPS', 'Participants with PFPS (n = 23) performed a lunge and SLS under three randomised conditions', 'people with Patellofemoral pain syndrome', 'patellofemoral pain syndrome (PFPS']","['McConnell Patellofemoral Joint Taping (PFJT) and Tibial Internal Rotation Limitation Taping (TIRLT', 'TIRLT, PFJT and no taping', 'McConnell patellofemoral joint and tibial internal rotation limitation taping techniques']","['Numerical Rating Scale (NRS', 'pain', 'Peak knee pain intensity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral pain syndrome'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0447801', 'cui_str': 'Structure of patellofemoral joint'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",23.0,0.053827,"RESULTS


Participants reported significantly less pain with the TIRLT and PFJT techniques compared with no tape during the lunge (p = 0.005 and p = 0.011, respectively) and SLS (p= 0.002 and p = 0.001, respectively).","[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Clifford', 'Affiliation': 'School of Allied Health and Health Research Institute, University of Limerick, Limerick, Ireland. Electronic address: Amanda.clifford@ul.ie.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dillon', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin 9, Ireland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hartigan', 'Affiliation': 'School of Allied Health, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': ""O'Leary"", 'Affiliation': 'Physiotherapy Department, University Hospital Kerry, Kerry, Ireland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Constantinou', 'Affiliation': 'School of Allied Health, Faculty of Health Sciences, Australian Catholic University, Brisbane, Queensland, Australia.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.010']
1870,32987359,Cognitive impairment in Parkinson's disease: Associations between subjective and objective cognitive decline in a large longitudinal study.,"BACKGROUND


Cognitive decline creates substantial morbidity and cost in Parkinson's disease (PD) and clinicians have limited tools for counseling patients on prognosis. We aimed to use data from a randomized, controlled trial of isradipine in Parkinson's disease (STEADY-PD III) to determine which objective cognitive domain deficits drive patient complaints of cognitive symptoms.
METHODS


Neuro-Quality of Life (Neuro-QoL) Cognition: General Concerns (GC), and Cognition: Executive Function (EF) (subjective measures), were administered at baseline, 1, 2, and 3 years in 324 people with PD. Baseline Montreal Cognitive Assessment (MoCA) was divided into 4 domains: visuospatial/executive, memory, attention, and language (objective measures). Spearman rank correlations and multiple regression models adjusted for other clinical variables evaluated associations between baseline Neuro-QoL domains and individual MoCA domains. Multiple regression models evaluated the association between baseline MoCA domain performance and Neuro-QoL change over three years. Cox proportional hazards predicted development of PD-MCI based on baseline and time-varying Neuro-QoL reporting.
RESULTS


Higher MoCA memory performance was associated with better Neuro-QoL-GC (β = 0.75, SE = 0.391, p = 0.05) and Neuro-QoL-EF (β = 0.81, SE = 0.36, p = 0.02) at baseline. There was a trend for baseline MoCA memory to predict the degree of subjective cognitive decline on the Neuro-QoL-EF (β = 0.70, SE = 0.42, p = 0.09). Baseline depression and anticholinergic use were associated with worsened Neuro-QoL-EF and Neuro-QoL-GC. Increasing subjective cognitive complaints in Neuro-QoL-EF were associated with development of PD-MCI over 3 years of follow-up (HR = 0.95, CI = 0.90-1.0, p = 0.039).
CONCLUSIONS


Objective memory impairment may be a stronger predictor than executive or visuospatial dysfunction for the presence of subjective cognitive complaints in early PD.",2020,Baseline depression and anticholinergic use were associated with worsened Neuro-QoL-EF and Neuro-QoL-GC.,"['324 people with PD', ""Parkinson's disease""]",['isradipine'],"['General Concerns (GC), and Cognition: Executive Function (EF) (subjective measures', 'visuospatial/executive, memory, attention, and language (objective measures', 'Neuro-Quality of Life (Neuro-QoL) Cognition', 'subjective cognitive complaints', 'Cognitive impairment', 'Baseline Montreal Cognitive Assessment (MoCA', 'baseline MoCA domain performance and Neuro-QoL change']","[{'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0071304', 'cui_str': 'Isradipine'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",324.0,0.0435964,Baseline depression and anticholinergic use were associated with worsened Neuro-QoL-EF and Neuro-QoL-GC.,"[{'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Mills', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: kmills16@jhmi.edu.'}, {'ForeName': 'Ruth B', 'Initials': 'RB', 'LastName': 'Schneider', 'Affiliation': 'University of Rochester School of Medicine and Density, Rochester, NY, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Saint-Hilaire', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'G Webster', 'Initials': 'GW', 'LastName': 'Ross', 'Affiliation': 'VA Pacific Islands Health Care System, Honolulu, HI, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': 'University of South Florida Morsani College of Medicine, Tampa, FL, USA.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Lang', 'Affiliation': ""Edmond J Safra Program in Parkinson's Disease, Toronto Western Hospital, UHN, Division of Neurology, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Halverson', 'Affiliation': 'The University of Utah School of Medicine, East Salt Lake City, UT, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Oakes', 'Affiliation': 'University of Rochester School of Medicine and Density, Rochester, NY, USA.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Eberly', 'Affiliation': 'University of Rochester School of Medicine and Density, Rochester, NY, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Litvan', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Blindauer', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Aquino', 'Affiliation': 'University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Simuni', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Marras', 'Affiliation': ""Edmond J Safra Program in Parkinson's Disease, Toronto Western Hospital, UHN, Division of Neurology, University of Toronto, Toronto, ON, Canada.""}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.09.028']
1871,32987360,Action observation improves sit-to-walk in patients with Parkinson's disease and freezing of gait. Biomechanical analysis of performance.,"INTRODUCTION


Freezing of gait (FoG) is one of the most disabling gait disorders in Parkinson's disease (PD), reflecting motor and cognitive impairments, mainly related to dopamine deficiency. Recent studies investigating kinematic and kinetic factors affecting gait in these patients showed a postural instability characterized by disturbed weight-shifting, inappropriate anticipatory postural adjustment, worse reactive postural control, and a difficulty executing complex motor tasks (i.e. sit-to-walk). These symptoms are difficult to alleviate and not very responsive to Levodopa. For this reason, additional therapeutic actions based on specific therapeutic protocols may help patients with their daily lives. We conducted a randomized control trial aimed to test if two clinical protocols for PD patients with FoG were effective to improve postural control.
METHODS


Rehabilitation protocols, conceived to improve gait, were based on learning motor exercises with the Action Observation plus Sonification (AOS) technique, or by the use of external sensory cues. We collected biomechanical data (Center of Mass COM, Center of Pressure COP, and moving timings), using the sit-to-walk task as a measure of motor and gait performance.
RESULTS


Kinetic and kinematic data showed that when treatment effects consolidate, patients treated with AOS protocol are more efficient in merging subsequent motor tasks (sit-to-stand and gait initiation), and diminished the total moving time and the area of the COP positions.
CONCLUSION


We demonstrated for the first time that PD patients with FoG treated with an AOS protocol aimed at relearning appropriate gait patterns increased balance control and re-acquired more efficient postural control.",2020,"RESULTS


Kinetic and kinematic data showed that when treatment effects consolidate, patients treated with AOS protocol are more efficient in merging subsequent motor tasks (sit-to-stand and gait initiation), and diminished the total moving time and the area of the COP positions.
","[""patients with Parkinson's disease and freezing of gait"", 'PD patients with FoG']","['learning motor exercises with the Action Observation plus Sonification (AOS) technique, or by the use of external sensory cues', 'Freezing of gait (FoG']","['total moving time and the area of the COP positions', 'balance control and re-acquired more efficient postural control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0016928', 'cui_str': 'Gait'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0442799', 'cui_str': 'Efficient'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]",,0.0179806,"RESULTS


Kinetic and kinematic data showed that when treatment effects consolidate, patients treated with AOS protocol are more efficient in merging subsequent motor tasks (sit-to-stand and gait initiation), and diminished the total moving time and the area of the COP positions.
","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Mezzarobba', 'Affiliation': 'Department of Life Sciences, University of Trieste, Italy; Azienda Sanitaria Universitaria Giuliano Isontina, Italy; Department of Medical, Surgical and Health Sciences, University of Trieste, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Grassi', 'Affiliation': 'Department of Life Sciences, University of Trieste, Italy.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Pellegrini', 'Affiliation': 'Azienda Sanitaria Universitaria Giuliano Isontina, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Catalan', 'Affiliation': 'Azienda Sanitaria Universitaria Giuliano Isontina, Italy.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Krüger', 'Affiliation': 'Gokhale Method Institute, CA, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Stragapede', 'Affiliation': 'Azienda Sanitaria Universitaria Giuliano Isontina, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Manganotti', 'Affiliation': 'Azienda Sanitaria Universitaria Giuliano Isontina, Italy; Department of Medical, Surgical and Health Sciences, University of Trieste, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bernardis', 'Affiliation': 'Department of Life Sciences, University of Trieste, Italy. Electronic address: pbernardis@units.it.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.09.029']
1872,32996559,Predictor Biomarkers of Nonelective Hospital Readmission and Mortality in Malnourished Hospitalized Older Adults.,"BACKGROUND


90-day mortality and rehospitalizations are important hospital quality metrics. Biomarkers that predict these outcomes among malnourished hospitalized patients could identify those at risk and help direct care plans.
OBJECTIVES


To identify biomarkers that predict 90-day (primary) and 30-day (secondary) mortality or nonelective rehospitalization.
DESIGN AND PARTICIPANTS


An analysis of the ability of biomarkers to predict 90- and 30-day mortality and rehospitalization among malnourished hospitalized patients.
SETTING


52 blood biomarkers were measured in 193 participants in NOURISH, a randomized trial that determined the effects of a nutritional supplement on 90-day readmission and death in patients >65 years. Composite outcomes were defined as readmission or death over 90-days or 30-days. Univariate Cox Proportional Hazards models were used to select best predictors of outcomes. Markers with the strongest association were included in multivariate stepwise regression. Final model of hospital readmission or death was derived using stepwise selection.
MEASUREMENTS


Nutritional, inflammatory, hormonal and muscle biomarkers.
RESULTS


Mean age was 76 years, 51% were men. In univariate models, 10 biomarkers were significantly associated with 90-day outcomes and 4 biomarkers with 30-day outcomes. In multivariate stepwise selection, glutamate, hydroxyproline, tau-methylhistidine levels, and sex were associated with death and readmission within 90-days. In stepwise selection, age-adjusted model that included sex and these 3 amino-acids demonstrated moderate discriminating ability over 90-days (C-statistic 0.68 (95%CI 0.61, 0.75); age-adjusted model that included sex, hydroxyproline and Charlson Comorbidity Index was predictive of 30-day outcomes (C-statistic 0.76 (95%CI 0.68, 0.85).
CONCLUSIONS


Baseline glutamate, hydroxyproline, and tau-methylhistidine levels, along with sex and age, predict risk of 90-day mortality and nonelective readmission in malnourished hospitalized older patients. This biomarker set should be further validated in prospective studies and could be useful in prognostication of malnourished hospitalized patients and guiding in-hospital care.",2020,"In multivariate stepwise selection, glutamate, hydroxyproline, tau-methylhistidine levels, and sex were associated with death and readmission within 90-days.","['in patients >65 years', 'Mean age was 76 years, 51% were men', 'malnourished hospitalized patients', 'malnourished hospitalized older patients', 'malnourished hospitalized patients and guiding in-hospital care', 'Malnourished Hospitalized Older Adults', '52 blood biomarkers were measured in 193 participants in NOURISH']",['nutritional supplement'],"['Nonelective Hospital Readmission and Mortality', 'predict 90-day (primary) and 30-day (secondary) mortality or nonelective rehospitalization', '90- and 30-day mortality and rehospitalization', '90-day readmission and death', 'hospital readmission or death', 'Nutritional, inflammatory, hormonal and muscle biomarkers', 'readmission or death over 90-days or 30-days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",193.0,0.0198383,"In multivariate stepwise selection, glutamate, hydroxyproline, tau-methylhistidine levels, and sex were associated with death and readmission within 90-days.","[{'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Pencina', 'Affiliation': ""Karol M. Pencina, PhD, Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, 221 Longwood Avenue, Boston, MA 02115 Phone: 617 525 9049, Email: kpencina@bhw.harvard.edu.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Luo', 'Affiliation': ''}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Baggs', 'Affiliation': ''}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Pereira', 'Affiliation': ''}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Deutz', 'Affiliation': ''}, {'ForeName': 'T G', 'Initials': 'TG', 'LastName': 'Travison', 'Affiliation': ''}]",The Journal of frailty & aging,['10.14283/jfa.2020.10']
1873,32979877,The fence technique: Autogenous bone graft versus 50% deproteinized bovine bone matrix / 50% autogenous bone graft-A clinical double-blind randomized controlled trial.,"OBJECTIVES


The aim of this short-term double-blind, parallel, randomized clinical trial was to compare bone augmentation grafting with 100% autogenous bone (AB) or 50% deproteinized bovine bone matrix (DBBM)/ 50% autogenous bone (BOAB) using a guided bone regeneration procedure, the fence technique, in a two-stage implant placement.
MATERIAL AND METHODS


Partially edentulous patients with extensive three-dimensional osseous defects were included in this study. The main outcome measure was the differences in bone volume from pre-surgery (T1) to 6 months post-surgery (T2). Bone height, chair-time, pain, functional limitation, and complications were also assessed.
RESULTS


Fifteen patients were allocated to the AB group and 15 patients to the BOAB group. The difference in bone volume from T1 to T2 was 648 mm 3  for the AB group and 869mm 3  for the BOAB group (difference between groups 221 mm 3  , 95% CI from -363 to 804, p = .442). The surgery pain VAS was 1.6 for the AB group and 2.3 for the BOAB group (difference between groups 0.8, 95% CI from 0.0 to 1.5, p = .045 favoring the AB group). The height difference in bone from T1 to T2 was 2.2 mm for the AB group and 3.7 mm for the BOAB group (difference between groups 1.5mm, 95% CI from 0.1 to 2.9, p = .038 favoring the BOAB group). For complications, chair-time, post-surgery pain, and functional limitation, there were no differences between AB and BOAB.
CONCLUSIONS


No significant differences, except for surgery pain VAS and difference in bone height, were observed in this trial comparing grafting with AB or BOAB.",2020,"For complications, chair-time, post-surgery pain and functional limitation there were no differences between AB and BOAB.
","['Partially edentulous patients with extensive three-dimensional osseous defects', 'Fifteen patients were allocated to the AB group and 15 patients to the BOAB group']","['technique: autogenous bone graft versus 50% deproteinized bovine bone matrix / 50% autogenous bone graft', 'bone augmentation grafting with 100% autogenous bone (AB) or 50% deproteinized bovine bone matrix (DBBM) / 50% autogenous bone (BOAB']","['surgery pain VAS', 'For complications, chair-time, post-surgery pain and functional limitation', 'Bone height, chair-time, pain, functional limitation, and complications', 'bone height', 'bone volume']","[{'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005962', 'cui_str': 'Bone matrix'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0440800', 'cui_str': 'Autogenous bone graft'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0005962', 'cui_str': 'Bone matrix'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",15.0,0.291789,"For complications, chair-time, post-surgery pain and functional limitation there were no differences between AB and BOAB.
","[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Merli', 'Affiliation': 'Clinica Merli, Rimini, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Nieri', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Mariotti', 'Affiliation': 'Clinica Merli, Rimini, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Merli', 'Affiliation': 'Clinica Merli, Rimini, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Franchi', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Quiroga Souki', 'Affiliation': 'Graduate Program in Orthodontics, Pontifical Catholic University of Minas Gerais, Belo Horizonte, Brazil.'}]",Clinical oral implants research,['10.1111/clr.13670']
1874,32979429,Long-term tDCS effects on neurophysiological measures of cognitive control in tobacco smokers.,"INTRODUCTION


In this study we assessed the effects of transcranial Direct Current Stimulation (tDCS) on inhibitory control and error processing as measures of cognitive control to better understand tDCS modulation of smoking behaviour.
METHODS


Smokers were allocated to six sessions of either active tDCS (n = 34) or sham tDCS (n = 35) (https://clinicaltrials.gov/ct2/show/NCT03027687). Immediately before, one day after, and three months after all tDCS sessions, participants performed the Go-NoGo task while we measured behavioural and neurophysiological responses.
RESULTS


One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers. However, a significant improvement in reaction times, and a decrease in No-Go P3 amplitudes for smoking cues was found three months after active tDCS.
CONCLUSION


Given the direction of the effect, we speculate that tDCS has a long-term modulatory learning effect on selective attention and motor inhibition.",2020,One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers.,"['tobacco smokers', 'Smokers']","['sham tDCS', 'transcranial Direct Current Stimulation (tDCS', 'tDCS', 'active tDCS']","['No-Go P3 amplitudes for smoking cues', 'reaction times', 'behavioural and neurophysiological measures of cognitive control']","[{'cui': 'C4505217', 'cui_str': 'Smokers, Tobacco'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0365492,One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers.,"[{'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Verveer', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands. Electronic address: verveer@essb.eur.nl.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Remmerswaal', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Frederik M', 'Initials': 'FM', 'LastName': 'van der Veen', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Ingmar H A', 'Initials': 'IHA', 'LastName': 'Franken', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107962']
1875,32980142,"[The effect of epinephrine for the treatment of spinal-hypotension: comparison with norepinephrine and phenylephrine, clinical trial].","BACKGROUND AND OBJECTIVES


Limited data are present on safety and efficiency of epinephrine for the prophylaxis and treatment of spinal-hypotension. This study was conducted to compare the effect of epinephrine with norepinephrine and phenylephrine on the treatment of spinal-hypotension and ephedrine requirement during cesarean delivery.
METHODS


One hundred and sixty parturients with uncomplicated pregnancies undergoing elective cesarean delivery under spinal anesthesia were recruited. They were allocated randomly to receive norepinephrine 5 μg.mL -1  (n=40), epinephrine 5 μg.mL -1  (n=40), phenylephrine 100 μg.mL -1  (n=40) or 0.9% saline infusions (n=40) immediately after induction of spinal anesthesia. Whenever systolic blood pressure drops to less than 80% of baseline, 5 mg of iv ephedrine was administered as rescue vasopressor. The incidence of hypotension, total number of hypotension episodes, the number of patients requiring ephedrine, the mean amount of ephedrine consumption and side effects were recorded.
RESULTS


There was no statistically significant difference in incidence of maternal hypotension between groups. The number of patients requiring ephedrine was significantly greater in group saline than in group phenylephrine (p <0.001). However, it was similar between phenylephrine, norepinephrine, and epinephrine groups. The mean ephedrine consumption was significantly higher in group saline than in norepinephrine, epinephrine, phenylephrine groups (p=0.001).
CONCLUSION


There is no statistically significant difference in incidence of hypotension and ephedrine consumption during spinal anesthesia for cesarean delivery with the use of epinephrine when compared to norepinephrine or phenylephrine. Epinephrine can be considered as an alternative agent for management of spinal hypotension.",2020,"The mean ephedrine consumption was significantly higher in group saline than in norepinephrine, epinephrine, phenylephrine groups (p=0.001).
","['spinal-hypotension', 'One hundred and sixty parturients with uncomplicated pregnancies undergoing elective cesarean delivery under spinal anesthesia were recruited']","['epinephrine', 'phenylephrine, norepinephrine', 'norepinephrine, epinephrine, phenylephrine', 'ephedrine', 'Epinephrine', 'norepinephrine or phenylephrine', 'epinephrine with norepinephrine and phenylephrine', 'epinephrine 5\xa0μg.mL -1', 'norepinephrine and phenylephrine', 'phenylephrine 100\xa0μg.mL -1  (n=40) or 0.9% saline infusions', 'phenylephrine', 'norepinephrine\xa05\xa0μg.mL -1']","['hypotension and ephedrine consumption', 'incidence of maternal hypotension', 'number of patients requiring ephedrine', 'mean ephedrine consumption', 'incidence of hypotension, total number of hypotension episodes, the number of patients requiring ephedrine, the mean amount of ephedrine consumption and side effects', 'systolic blood pressure drops']","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}]",160.0,0.351953,"The mean ephedrine consumption was significantly higher in group saline than in norepinephrine, epinephrine, phenylephrine groups (p=0.001).
","[{'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Biricik', 'Affiliation': 'Cukurova University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Adana, Turquia. Electronic address: ebrubiricik01@gmail.com.'}, {'ForeName': 'Feride', 'Initials': 'F', 'LastName': 'Karacaer', 'Affiliation': 'Cukurova University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Adana, Turquia.'}, {'ForeName': 'İlker', 'Initials': 'İ', 'LastName': 'Ünal', 'Affiliation': 'Çukurova University, Faculty of Medicine, Department of Statistics, Adana, Turquia.'}, {'ForeName': 'Mete', 'Initials': 'M', 'LastName': 'Sucu', 'Affiliation': 'Çukurova University, Faculty of Medicine, Department of Obstetrics and Gynecology, Adana, Turquia.'}, {'ForeName': 'Hakkı', 'Initials': 'H', 'LastName': 'Ünlügenç', 'Affiliation': 'Cukurova University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Adana, Turquia.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.04.017']
1876,32980725,Radiomic features of magnetic resonance images as novel preoperative predictive factors of bone invasion in meningiomas.,"PURPOSE


Bone invasion in meningiomas is a prognostic determinant, and a priori knowledge may alter surgical techniques. Here, we aim to predict bone invasion in meningiomas using radiomic signatures based on preoperative, contrast-enhanced T1-weighted (T1C) and T2-weighted (T2) magnetic resonance imaging (MRI).
METHODS


In this retrospective study, 490 patients diagnosed with meningiomas, including WHO grade I (448cases), grade II (38cases), and grade III (4cases), were enrolled and 213 out of 490 cases (43.5 %) had bone invasion. The patients were randomly divided into training (n = 343) and test (n = 147) datasets at a 7:3 ratio. For each patient, 1227 radiomic features were extracted from T1C and T2, respectively. Spearman's correlation and least absolute shrinkage and selection operator (LASSO) regression analyses were performed to select the most informative features. Subsequently, a 5-fold cross-validation was used to compare the performance of different classification algorithms, and logistic regression was chosen to predict the risk of bone invasion.
RESULTS


Eight radiomic features were selected from T1C and T2 respectively, and three models were built using radiomic features. The radiomic models derived from T1C alone or a combination of T1C and T2 had the best performance in predicting risk of bone invasion, with areas under the curve in the training dataset of 0.714 [95 % CI, 0.660-0.768] and 0.722 [95 % CI, 0.668-0.776] and in the test datasets of 0.715 [95 % CI, 0.632-0.798] and 0.713 [95 % CI, 0.628-0.798], respectively.
CONCLUSIONS


The radiomic model may aid clinicians with preoperative prediction of bone invasion by meningiomas, which can help in predicting prognosis and devising surgical strategies.",2020,"The radiomic models derived from T1C alone or a combination of T1C and T2 had the best performance in predicting risk of bone invasion, with areas under the curve in the training dataset of 0.714 [95 % CI, 0.660-0.768] and 0.722","['490 patients diagnosed with meningiomas, including WHO grade I (448cases), grade II (38cases), and grade III (4cases), were enrolled and 213 out of 490 cases (43.5 %) had bone invasion', 'bone invasion in meningiomas']","['magnetic resonance images', 'radiomic signatures based on preoperative, contrast-enhanced T1-weighted (T1C) and T2-weighted (T2) magnetic resonance imaging (MRI']",['risk of bone invasion'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025286', 'cui_str': 'Meningioma'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]","[{'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]",490.0,0.0309829,"The radiomic models derived from T1C alone or a combination of T1C and T2 had the best performance in predicting risk of bone invasion, with areas under the curve in the training dataset of 0.714 [95 % CI, 0.660-0.768] and 0.722","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China; Key Laboratory of Medical Imaging of Gansu Province, Lanzhou, China.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Philips Healthcare, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Yuntai', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Guojin', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Junlin', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China. Electronic address: lzuzjl601@163.com.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109287']
1877,32980772,High-frequency repetitive transcranial magnetic stimulation over the primary motor cortex relieves musculoskeletal pain in patients with Parkinson's disease: A randomized controlled trial.,"BACKGROUND


Pain is common in Parkinson's disease, and there is no effective treatment. We conducted a clinical trial to determine whether high-frequency repetitive transcranial magnetic stimulation over the primary motor cortex alleviates musculoskeletal pain in patients with Parkinson's disease.
METHODS


In this single-center and double-blind trial, 52 patients with Parkinson's disease and musculoskeletal pain were randomly allocated to 26-member groups receiving 5 sessions of either 20-Hz repetitive transcranial magnetic stimulation or sham stimulation over the primary motor cortex. The participants underwent assessments in the ""ON"" medication state at baseline, after the fifth session, and at 2- and 4-week follow-up timepoints. The primary outcomes were pain scores on a numeric rating scale. The secondary outcomes were scores on clinical scales assessing motor symptoms, depression, anxiety, autonomic symptoms, sleep quality, and the overall severity of Parkinson's disease.
RESULTS


Analyses revealed significant group × time interactions for numeric rating scale pain scores (p < 0.001), motor symptom scores (p < 0.001), depression scores (p = 0.009), anxiety scores (p = 0.013), and overall disease severity scores (p < 0.001). Post hoc analyses confirmed that the repetitive transcranial magnetic stimulation group, but not the sham stimulation group, exhibited significant improvements in numeric rating scale pain scores, motor symptom scores, depression scores, anxiety scores, and overall disease severity scores.
CONCLUSION


High-frequency repetitive transcranial magnetic stimulation over the primary motor cortex may be an effective adjunct therapy for alleviating musculoskeletal pain in patients with Parkinson's disease.",2020,"RESULTS


Analyses revealed significant group × time interactions for numeric rating scale pain scores (p < 0.001), motor symptom scores (p < 0.001), depression scores (p = 0.009), anxiety scores (p = 0.013), and overall disease severity scores (p < 0.001).","[""patients with Parkinson's disease"", ""52 patients with Parkinson's disease and musculoskeletal pain""]","['repetitive transcranial magnetic stimulation', 'high-frequency repetitive transcranial magnetic stimulation', '20-Hz repetitive transcranial magnetic stimulation or sham stimulation over the primary motor cortex', 'High-frequency repetitive transcranial magnetic stimulation']","[""scores on clinical scales assessing motor symptoms, depression, anxiety, autonomic symptoms, sleep quality, and the overall severity of Parkinson's disease"", 'musculoskeletal pain', 'numeric rating scale pain scores, motor symptom scores, depression scores, anxiety scores, and overall disease severity scores', 'numeric rating scale pain scores', 'anxiety scores', 'pain scores on a numeric rating scale', 'depression scores', 'overall disease severity scores', 'motor symptom scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",52.0,0.451476,"RESULTS


Analyses revealed significant group × time interactions for numeric rating scale pain scores (p < 0.001), motor symptom scores (p < 0.001), depression scores (p = 0.009), anxiety scores (p = 0.013), and overall disease severity scores (p < 0.001).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Neurobiology, Neurology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute of Geriatrics, Beijing, China; Department of Neurology, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei, China.'}, {'ForeName': 'Tao-Mian', 'Initials': 'TM', 'LastName': 'Mi', 'Affiliation': ""Department of Neurobiology, Neurology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute of Geriatrics, Beijing, China; Clinical and Research Center for Parkinson's Disease; Key Laboratory for Neurodegenerative Disease of the Ministry of Education, Beijing Key Laboratory for Parkinson's Disease, Parkinson Disease Center of Beijing Institute for Brain Disorders, Beijing, China.""}, {'ForeName': 'Ben-Fan', 'Initials': 'BF', 'LastName': 'Zhu', 'Affiliation': 'Department of Pain, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Jing-Hong', 'Initials': 'JH', 'LastName': 'Ma', 'Affiliation': ""Department of Neurobiology, Neurology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute of Geriatrics, Beijing, China; Clinical and Research Center for Parkinson's Disease; Key Laboratory for Neurodegenerative Disease of the Ministry of Education, Beijing Key Laboratory for Parkinson's Disease, Parkinson Disease Center of Beijing Institute for Brain Disorders, Beijing, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': ""Department of Neurobiology, Neurology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute of Geriatrics, Beijing, China; Clinical and Research Center for Parkinson's Disease; Key Laboratory for Neurodegenerative Disease of the Ministry of Education, Beijing Key Laboratory for Parkinson's Disease, Parkinson Disease Center of Beijing Institute for Brain Disorders, Beijing, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Neurobiology, Neurology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute of Geriatrics, Beijing, China; Clinical and Research Center for Parkinson's Disease; Key Laboratory for Neurodegenerative Disease of the Ministry of Education, Beijing Key Laboratory for Parkinson's Disease, Parkinson Disease Center of Beijing Institute for Brain Disorders, Beijing, China.""}, {'ForeName': 'Wen-Ming', 'Initials': 'WM', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei, China. Electronic address: yangwm8810@126.com.'}, {'ForeName': 'Piu', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': ""Department of Neurobiology, Neurology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute of Geriatrics, Beijing, China; Clinical and Research Center for Parkinson's Disease; Key Laboratory for Neurodegenerative Disease of the Ministry of Education, Beijing Key Laboratory for Parkinson's Disease, Parkinson Disease Center of Beijing Institute for Brain Disorders, Beijing, China; National Clinical Research Center for Geriatric Disorders, Beijing, China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China. Electronic address: pbchan@hotmail.com.""}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.07.006']
1878,32990231,[Effect of Straumann implant on crown appearance in immediate implant restoration of maxillary anterior teeth].,"OBJECTIVE


To investigate the effect of Straumann implant on crown appearance in the immediate implant restoration of maxillary anterior teeth.
METHODS


This study was conducted among 86 patients undergoing immediate implant restoration of maxillary anterior teeth between January and December, 2018. We randomized the patients into control group for treatment with immediate implant restoration and study group receiving additional Straumann implant. The effects of restoration, bone absorption at 6 months, implant length, implant diameter, root protrusion, gingival color, far and middle gingival papilla, lip side gingival height, near and middle gingival papilla, and lip side gingival curve were compared between the two groups.
RESULTS


The repair effect in the study group was better than that in the control group ( P  < 0.05). The implant length and implant diameter were significantly greater in the study group than in the control group. The root protrusion, gingival color, far and middle gingival papilla, lip side gingival height, near and middle gingival papilla, and lip side gingival curve were all better in the study group. The height of marginal bone in the study group was significantly higher than that in the control group ( P  < 0.05).
CONCLUSIONS


Straumann implant can be used in immediate implant restoration of maxillary anterior teeth to achieve a better aesthetic effect.",2020,"The height of marginal bone in the study group was significantly higher than that in the control group ( P  < 0.05).
","['86 patients undergoing immediate implant restoration of maxillary anterior teeth between January and December, 2018', 'maxillary anterior teeth']","['immediate implant restoration and study group receiving additional Straumann implant', 'Straumann implant']","['bone absorption at 6 months, implant length, implant diameter, root protrusion, gingival color, far and middle gingival papilla, lip side gingival height, near and middle gingival papilla, and lip side gingival curve', 'implant length and implant diameter', 'root protrusion, gingival color, far and middle gingival papilla, lip side gingival height, near and middle gingival papilla, and lip side gingival curve', 'repair effect', 'height of marginal bone']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0226964', 'cui_str': 'Structure of lingual papillae'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}]",86.0,0.0218608,"The height of marginal bone in the study group was significantly higher than that in the control group ( P  < 0.05).
","[{'ForeName': 'Zhongxiong', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Department of Stomatology, Guangzhou Hospital of Integrated Traditional and West Medicine, Guangzhou 510800, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jia', 'Affiliation': 'Stomatological Hospital of Southern Medical University, Guangzhou 510220, China.'}, {'ForeName': 'Shaoqun', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Stomatology, Guangzhou Hospital of Integrated Traditional and West Medicine, Guangzhou 510800, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Shao', 'Affiliation': 'Department of Stomatology, Guangzhou Hospital of Integrated Traditional and West Medicine, Guangzhou 510800, China.'}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,['10.12122/j.issn.1673-4254.2020.09.22']
1879,32990234,[Construction and validation of a nomogram for predicting the risk of portal vein thrombosis after splenectomy in patients with hepatitis B cirrhosis].,"OBJECTIVE


To construct and validate an individualized nomogram to predict the probability of occurrence of portal vein thrombosis (PVT) after splenectomy in patients with hepatitis B cirrhosis.
METHODS


We retrospectively collected the clinical data from 180 patients with hepatitis B cirrhosis undergoing splenectomy with postoperative anticoagulation therapy during the period from January, 2014 to January, 2020 in our hospital. The patients were randomized into modeling group ( n = 120) and validation group ( n =60), and the former group was further divided into PVT group ( n =49) and non-PVT group ( n =71) according to the occurrence of PVT occurred within 1 month after splenectomy. The independent risk factors of PVT after splenectomy were screened in the modeling group using univariate and multivariate binary logistic regression analyses and were used for construction of the nomogram prediction model. The area under the receiver-operating characteristic (AUROC) curve (C-index), GiViTI calibration belt and Hosmer-Lemeshow test, and the DCA curve were used to estimate the discrimination power, calibration and clinical efficiency of the prediction model in both the model construction group and validation group.
RESULTS


Univariate and multivariate logistic regression analyses showed that a history of hemorrhage, portal vein diameter, spleen vein diameter, spleen volume, varicose, postoperative platelet change, and postoperative D-dimer differed significantly between PVT group and non-PVT group ( P  < 0.05), and portal vein diameter, spleen vein diameter, and postoperative platelet change were independent risk factors of PVT after splenectomy ( P  < 0.05). The prediction model had a good discrimination power with AUROC (C-index) of 0.880 (95%  CI : 0.818-0.942) in the modeling group and 0.873 (95%  CI : 0.785-0.960) in the validation group. The 80% and 95% CI  region of GiViTI calibration belt did not cover the 45-degree diagonal bisector line ( P =0.965 and 0.632, respectively), and the P-values of the Hosmer-Lemeshow test were 0.624 and 0.911, respectively, suggesting a high reliability of the predicted probability by the model. DCA curve analysis showed a threshold probability of 30.5%, with a net benefit of 30% in the modeling group and 34% in the validation group, indicating a good clinical efficiency of the model.
CONCLUSIONS


The model for predicting the risk of PVT after splenectomy in patients with hepatitis B cirrhosis can help in early identification of patients having high risks of PVT.",2020,The prediction model had a good discrimination power with AUROC (C-index) of 0.880 (95%  CI : 0.818-0.942) in the modeling group and 0.873 (95%  CI : 0.785-0.960) in the validation group.,"['180 patients with hepatitis B cirrhosis undergoing splenectomy with postoperative anticoagulation therapy during the period from January, 2014 to January, 2020 in our hospital', 'patients with hepatitis B cirrhosis']",[],"['history of hemorrhage, portal vein diameter, spleen vein diameter, spleen volume, varicose, postoperative platelet change, and postoperative D-dimer', 'portal vein diameter, spleen vein diameter, and postoperative platelet change', 'portal vein thrombosis', 'portal vein thrombosis (PVT']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],"[{'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032718', 'cui_str': 'Portal vein structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439652', 'cui_str': 'Varicose'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0235603', 'cui_str': 'Platelet changes'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0155773', 'cui_str': 'Portal vein thrombosis'}]",180.0,0.0292147,The prediction model had a good discrimination power with AUROC (C-index) of 0.880 (95%  CI : 0.818-0.942) in the modeling group and 0.873 (95%  CI : 0.785-0.960) in the validation group.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Hepatobiliary Surgery, Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Hepatobiliary Surgery, Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Tu', 'Affiliation': 'Department of Hepatobiliary Surgery, Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China.'}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,['10.12122/j.issn.1673-4254.2020.09.07']
1880,32991045,Trichoscopy as an evaluation method for alopecia areata treatment: A comparative study.,"BACKGROUND


Trichoscopy is a useful tool for diagnosis and follow-up of alopecia areata (AA) patients. Both platelet-rich plasma (PRP) and intralesional corticosteroids (ILCs) are important treatment modalities of patchy AA.
AIM


Trichoscopic diagnosis of AA and monitoring the treatment response to PRP versus ILCs in patchy AA treatment.
PATIENTS/METHODS


This comparative study included 31 patients with patchy AA, divided into two groups: (group A) received ILCs while (group B) received PRP once monthly for 3 months. Evaluation was done by Severity of Alopecia Tool (SALT) score, Alopecia Areata Symptom Impact Scale (AASIS), photography, and dermoscopy.
RESULTS


There was a significant improvement in trichoscopic findings in both groups with regard to the number of follicular units per opening, black dots, broken hairs, and dystrophic changes. Final SALT score showed significant lower levels in both groups compared to baseline levels (P = .025 & P = .008). Final AASIS showed significant decrease in group B (P = .006) not in group A (P = .062).
CONCLUSION


Trichoscopy can help in the diagnosis, evaluation of the efficacy and safety of both modalities and might give a clue for treatment response. Both ILCs and PRP were effective in patchy AA treatment.",2020,"There was a significant improvement in trichoscopic findings in both groups with regard the number of follicular units per opening, black dots, broken hairs and dystrophic changes.","['alopecia areata (AA) patients', '31 patients with patchy AA']","['PRP', 'platelet rich plasma (PRP) and intra-lesional corticosteroids (ILCs', 'Trichoscopy', 'ILCs']","['trichoscopic findings', 'Severity of Alopecia Tool (SALT) score, Alopecia Areata Symptom Impact Scale (AASIS), photography and dermoscopy', 'number of follicular units per opening, black dots, broken hairs and dystrophic changes']","[{'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205413', 'cui_str': 'Patchy'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C1449565', 'cui_str': 'Dermatoscopy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",31.0,0.0138871,"There was a significant improvement in trichoscopic findings in both groups with regard the number of follicular units per opening, black dots, broken hairs and dystrophic changes.","[{'ForeName': 'Marwa M', 'Initials': 'MM', 'LastName': 'Fawzy', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Cairo University, New Cairo, Egypt.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Abdel Hay', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Cairo University, New Cairo, Egypt.'}, {'ForeName': 'Faisal Nouredin', 'Initials': 'FN', 'LastName': 'Mohammed', 'Affiliation': 'Department of Dermatology and Venereology, National Research Centre, Giza, Egypt.'}, {'ForeName': 'Khadiga S', 'Initials': 'KS', 'LastName': 'Sayed', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Cairo University, New Cairo, Egypt.'}, {'ForeName': 'Mona El Desoky', 'Initials': 'MED', 'LastName': 'Ghanem', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Cairo University, New Cairo, Egypt.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Ezzat', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Cairo University, New Cairo, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13739']
1881,32987492,Evaluation of postoperative pain in patients undergoing modified radical mastectomy with pectoralis or serratus-intercostal fascial plane blocks.,"BACKGROUND


Regional nerve blocks are an integral part of multimodal analgesia and should be chosen based on their efficacy, convenience, and minimal side effects. Here, we compare the use of pectoral (PEC II) and serratus-intercostal fascial plane (SIFP) blocks in breast carcinoma cases undergoing modified radical mastectomy (MRM) in terms of the postoperative analgesic efficacy and shoulder mobility.
METHODS


The primary outcome of this prospective controlled study was to compare the postoperative static and dynamic pain scores, and the secondary outcome was to assess the shoulder pain, range of shoulder joint motion, and hemodynamic parameters. Sixty patients were randomly allocated to three groups and given general anesthesia. All patients received paracetamol, diclofenac, and rescue doses of tramadol based on the Institute's Acute Pain Service (APS) policy. No block was performed in group C (control), whereas groups P and S received PEC II and SIFP blocks, respectively, before surgical incision.
RESULTS


The groups were comparable in terms of age, weight, height, and body mass index distribution (P > 0.05). Dynamic pain relief was significantly better 12 and 24 h postoperatively in groups P (P = 0.034 and P = 0.04, respectively) and S (P = 0.01 and P = 0.02, respectively) compared to group C. Shoulder pain relief and shoulder mobility were better in group S, while the hemodynamic parameters were more stable in group P.
CONCLUSIONS


Both SIFP and PEC blocks have comparable dynamic and static pain relief with better shoulder pain scores in patients receiving SIFP.",2020,"Dynamic pain relief was significantly better 12 and 24 h postoperatively in groups P (P = 0.034 and P = 0.04, respectively) and S (P = 0.01 and P = 0.02, respectively) compared to group C. Shoulder pain relief and shoulder mobility were better in group S, while the hemodynamic parameters were more stable in group P.
CONCLUSIONS


Both SIFP and PEC blocks have comparable dynamic and static pain relief with better shoulder pain scores in patients receiving SIFP.","['patients undergoing modified radical mastectomy with pectoralis or serratus-intercostal fascial plane blocks', 'patients receiving SIFP', 'Sixty patients', 'breast carcinoma cases undergoing']","['tramadol', 'modified radical mastectomy (MRM', 'pectoral (PEC II) and serratus-intercostal fascial plane (SIFP) blocks', 'general anesthesia', 'paracetamol, diclofenac']","['shoulder pain, range of shoulder joint motion, and hemodynamic parameters', 'dynamic and static pain relief with better shoulder pain scores', 'Shoulder pain relief and shoulder mobility', 'Dynamic pain relief', 'postoperative static and dynamic pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0678222', 'cui_str': 'Carcinoma of breast'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0055065', 'cui_str': 'CEP combination'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",60.0,0.0575978,"Dynamic pain relief was significantly better 12 and 24 h postoperatively in groups P (P = 0.034 and P = 0.04, respectively) and S (P = 0.01 and P = 0.02, respectively) compared to group C. Shoulder pain relief and shoulder mobility were better in group S, while the hemodynamic parameters were more stable in group P.
CONCLUSIONS


Both SIFP and PEC blocks have comparable dynamic and static pain relief with better shoulder pain scores in patients receiving SIFP.","[{'ForeName': 'Ushkiran', 'Initials': 'U', 'LastName': 'Kaur', 'Affiliation': 'Department of Anesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Chetna', 'Initials': 'C', 'LastName': 'Shamshery', 'Affiliation': 'Department of Anesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Department of Anesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Neel', 'Initials': 'N', 'LastName': 'Prakash', 'Affiliation': 'Department of Anesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Ramya Chakrapani', 'Initials': 'RC', 'LastName': 'Valiveru', 'Affiliation': 'Department of Endocrine Surgery, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Prabhaker', 'Initials': 'P', 'LastName': 'Mishra', 'Affiliation': 'Department of Biostatistics and Health Informatics, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}]",Korean journal of anesthesiology,['10.4097/kja.20159']
1882,32988625,[Comparison of palonosetron-dexamethasone and ondansetron-dexamethasone for prevention of postoperative nausea and vomiting in middle ear surgery: a randomized clinical trial].,"BACKGROUND


Postoperative nausea and vomiting is the second most common complaint in the postoperative period after pain. The incidence of postoperative nausea and vomiting was 60-80% in middle ear surgeries in the absence of antiemetic prophylaxis. Because of this high incidence of postoperative nausea and vomiting, we aimed to assess the effect of palonosetron-dexamethasone and ondansetron-dexamethasone combination for the prevention of postoperative nausea and vomiting in patients of middle ear surgery.
METHODS


Sixty-four patients, scheduled for middle ear surgery, were randomized into two groups to receive the palonosetron-dexamethasone and ondansetron-dexamethasone combination intravenously before induction of anesthesia. Anesthesia technique was standardized in all patients. Postoperatively, the incidences and severity of nausea and vomiting, the requirement of rescue antiemetic, side effects and patient satisfaction score were recorded.
RESULTS


Demographics were similar in the study groups. The incidence difference of nausea was statistically significant between groups O and P at a time interval of 2-6hours only (p=0.026). The incidence and severity of vomiting were not statistically significant between groups O and P during the whole study period. The overall incidence of postoperative nausea and vomiting (0-24hours postoperatively) was 37.5% in group O and 9.4% in group P (p=0.016). Absolute risk reduction with palonosetron-dexamethasone was 28%, the relative risk reduction was 75%, and the number-needed-to-treat was 4. The patient's satisfaction score was higher in group P than group O (p=0.016). The frequency of rescue medication was more common in group O than in group P patients (p=0.026).
CONCLUSION


The combination of palonosetron-dexamethasone is superior to ondansetron-dexamethasone for the prevention of postoperative nausea and vomiting after middle ear surgeries.",2020,"The frequency of rescue medication was more common in group O than in group P patients (p=0.026).
","['after middle ear surgeries', 'patients of middle ear surgery', 'middle ear surgery', 'Sixty-four patients, scheduled for middle ear surgery']","['palonosetron-dexamethasone', 'palonosetron-dexamethasone and ondansetron-dexamethasone combination', 'ondansetron-dexamethasone', 'palonosetron-dexamethasone and ondansetron-dexamethasone']","[""patient's satisfaction score"", 'postoperative nausea and vomiting', 'incidence and severity of vomiting', 'nausea', 'incidences and severity of nausea and vomiting, the requirement of rescue antiemetic, side effects and patient satisfaction score', 'frequency of rescue medication', 'overall incidence of postoperative nausea and vomiting', 'relative risk reduction']","[{'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}]","[{'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.247825,"The frequency of rescue medication was more common in group O than in group P patients (p=0.026).
","[{'ForeName': 'Vinit Kumar', 'Initials': 'VK', 'LastName': 'Srivastava', 'Affiliation': 'Apollo Hospitals Bilaspur, Department of Anesthesiology, Chhattisgarh, Índia. Electronic address: drvinit75@gmail.com.'}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Apollo Hospitals Bilaspur, Department of Anesthesiology, Chhattisgarh, Índia.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'All India Institute of Medical Sciences, Department of Anesthesiology, Rishikesh, Uttarakhand, Índia.'}, {'ForeName': 'Sweta Anil', 'Initials': 'SA', 'LastName': 'Deshmukh', 'Affiliation': 'Apollo Hospitals Bilaspur, Department of Anesthesiology, Chhattisgarh, Índia.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Shree', 'Affiliation': 'Apollo Hospitals Bilaspur, Department of Anesthesiology, Chhattisgarh, Índia.'}, {'ForeName': 'Partha Pratim', 'Initials': 'PP', 'LastName': 'Misra', 'Affiliation': 'Apollo Hospitals Bilaspur, Department of Ear Nose Throat Surgery, Chhattisgarh, Índia.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.04.016']
1883,32988996,Pertuzumab and trastuzumab emtansine in patients with HER2-amplified metastatic colorectal cancer: the phase II HERACLES-B trial.,"BACKGROUND


HER2 is a therapeutic target for metastatic colorectal cancer (mCRC), as demonstrated in the pivotal HERACLES-A (HER2 Amplification for Colo-rectaL cancer Enhanced Stratification) trial with trastuzumab and lapatinib. The aim of HERACLES-B trial is to assess the efficacy of the combination of pertuzumab and trastuzumab-emtansine (T-DM1) in this setting.
METHODS


HERACLES-B was a single-arm, phase II trial, in patients with histologically confirmed  RAS/BRAF  wild-type and HER2+ mCRC refractory to standard treatments. HER2 positivity was assessed by immunohistochemistry and in situ hybridisation according to HERACLES criteria. Patients were treated with pertuzumab (840 mg intravenous load followed by 420 mg intravenous every 3 weeks) and T-DM1 (3.6 mg/kg every 3 weeks) until disease progression or toxicity. Primary and secondary end points were objective response rate (ORR) and progression-free survival (PFS). With a Fleming/Hern design (H0=ORR 10%; α=0.05; power=0.85), 7/30 responses were required to demonstrate an ORR ≥30% (H1).
RESULTS


Thirty-one patients, 48% with ≥4 lines of previous therapies, were treated and evaluable. ORR was 9.7% (95% CI: 0 to 28) and stable disease (SD) 67.7% (95% CI: 50 to 85). OR/SD ≥4 months was associated with higher HER2 immunohistochemistry score (3+ vs 2+) (p = 0.03). Median PFS was 4.1 months (95% CI: 3.6 to 5.9). Drug-related grade (G) 3 adverse events were observed in two patients (thrombocytopaenia); G≤2 AE in 84% of cycles (n = 296), mainly nausea and fatigue.
CONCLUSIONS


HERACLES-B trial did not reach its primary end point of ORR; however, based on high disease control, PFS similar to other anti-HER2 regimens, and low toxicity, pertuzumab in combination with T-DM1 can be considered for HER2+mCRC as a potential therapeutic resource.
TRIAL REGISTRATION NUMBER


2012-002128-33 and NCT03225937.",2020,"3 adverse events were observed in two patients (thrombocytopaenia); G≤2 AE in 84% of cycles (n = 296), mainly nausea and fatigue.
","['metastatic colorectal cancer (mCRC', 'patients with histologically confirmed  RAS/BRAF  wild-type and HER2+ mCRC refractory to standard treatments', 'patients with HER2-amplified metastatic colorectal cancer']","['pertuzumab and trastuzumab-emtansine (T-DM1', 'trastuzumab and lapatinib', 'Pertuzumab and trastuzumab emtansine', 'pertuzumab', 'HER2+mCRC']","['HER2 positivity', 'higher HER2 immunohistochemistry score', 'mainly nausea and fatigue', 'Median PFS', 'ORR', 'Drug-related grade (G', 'objective response rate (ORR) and progression-free survival (PFS']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.127319,"3 adverse events were observed in two patients (thrombocytopaenia); G≤2 AE in 84% of cycles (n = 296), mainly nausea and fatigue.
","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Sartore-Bianchi', 'Affiliation': 'Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Oncologia Medica 1, Istituto Oncologico Veneto - IRCCS, Padova, Italy.'}, {'ForeName': 'Cosimo', 'Initials': 'C', 'LastName': 'Martino', 'Affiliation': 'Candiolo Cancer Institute FPO-IRCCS, Candiolo (TO), Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Fenocchio', 'Affiliation': 'Multidisciplinary Outpatient Oncology Clinic, Candiolo Cancer Institute FPO-IRCCS, Candiolo (TO), Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Tosi', 'Affiliation': 'Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ghezzi', 'Affiliation': 'Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Leone', 'Affiliation': 'Department of Oncology, ASL BI, Ospedale degli Infermi di Biella, Biella, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bergamo', 'Affiliation': 'Oncologia Medica 1, Istituto Oncologico Veneto - IRCCS, Padova, Italy.'}, {'ForeName': 'Vittorina', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'Oncologia Medica 1, Istituto Oncologico Veneto - IRCCS, Padova, Italy.'}, {'ForeName': 'Fortunato', 'Initials': 'F', 'LastName': 'Ciardiello', 'Affiliation': 'Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Caserta, Campania, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ardizzoni', 'Affiliation': 'UOC Oncologia Medica, Policlinico S. Orsola, Dipartimento di Medicina Specialistica, di Laboratorio e Sperimentale, Università Alma Mater, Bologna, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Amatu', 'Affiliation': 'Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Bencardino', 'Affiliation': 'Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Valtorta', 'Affiliation': 'Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Grassi', 'Affiliation': 'Candiolo Cancer Institute FPO-IRCCS, Candiolo (TO), Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Dipartimento di Oncologia, IRCCS- Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Bonoldi', 'Affiliation': 'Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sapino', 'Affiliation': 'Candiolo Cancer Institute FPO-IRCCS, Candiolo (TO), Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Vanzulli', 'Affiliation': 'Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Regge', 'Affiliation': 'Candiolo Cancer Institute FPO-IRCCS, Candiolo (TO), Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cappello', 'Affiliation': 'Candiolo Cancer Institute FPO-IRCCS, Candiolo (TO), Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bardelli', 'Affiliation': 'Candiolo Cancer Institute FPO-IRCCS, Candiolo (TO), Italy.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Trusolino', 'Affiliation': 'Candiolo Cancer Institute FPO-IRCCS, Candiolo (TO), Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Marsoni', 'Affiliation': 'Precision Oncology, IFOM-FIRC Institute of Molecular Oncology, Milano, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Siena', 'Affiliation': 'Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy salvatore.siena@unimi.it.'}]",ESMO open,['10.1136/esmoopen-2020-000911']
1884,32991477,Effects of visual feedback balance training with the Pro-kin system on walking and self-care abilities in stroke patients.,"Some scholars' studies have demonstrated that Pro-kin balance system training is able to promote the recovery of the balance function in stroke patients. The present study has expanded on those studies, and was not merely limited to studying balance, but also encompassed walking and self-care abilities of the patients; furthermore, the association among balance and walking and self-care abilities was also explored.A total of 40 stroke patients were randomly and equally divided into 2 groups: the control group (n = 20) and the treatment group (n = 20). Both groups underwent conventional balance training, although the treatment group also underwent visual feedback balance training with the Pro-kin system. The balance function was assessed using the Berg Balance Scale (BBS), the Timed ""Up & Go"" (TUG) test, and Pro-kin system parameters. The Pro-kin system parameters included the perimeter and ellipse area, which were both tested once with eyes open (EO) and eyes closed (EC). Walking ability was assessed using the Holden Walking Ability Scale, according to the Functional Ambulation Classification (FAC). The self-care abilities were assessed with the Barthel Index (BI). The tests were conducted prior to training, and 3 weeks after the end of the training programme.No significant differences were noted among the groups before the training. After 3 weeks of training, for both the groups, significant improvements in balance and the walking and self-care abilities were noted: The BBS value was significantly increased (P < .05), whereas the TUG, perimeter, and ellipse area with EO and EC measurements were significantly decreased after treatment (P < .05). The FAC and BI readings were significantly increased after treatment (P < 0.05), and the treatment group outperformed the control group (P < .05). Furthermore, the balance function was shown to be strongly correlated with the walking and self-care abilities (P < .01).The present study has demonstrated that the use of the Pro-kin visual feedback balance training system in combination with conventional training is a viable method for improving walking and self-care abilities of stroke patients.",2020,"After 3 weeks of training, for both the groups, significant improvements in balance and the walking and self-care abilities were noted: The BBS value was significantly increased (P < .05), whereas the TUG, perimeter, and ellipse area with EO and EC measurements were significantly decreased after treatment (P < .05).","['40 stroke patients', 'stroke patients']","['visual feedback balance training with the Pro-kin system', 'conventional balance training']","['Walking ability', 'walking and self-care abilities', 'balance function', 'BBS value', 'FAC and BI readings', 'Holden Walking Ability Scale, according to the Functional Ambulation Classification (FAC', 'TUG, perimeter, and ellipse area with EO and EC measurements', 'balance and the walking and self-care abilities', 'Berg Balance Scale (BBS), the Timed ""Up & Go"" (TUG) test, and Pro-kin system parameters']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0682416', 'cui_str': 'Ruanda language'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0562734', 'cui_str': 'Ability to perform personal care activity'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0682416', 'cui_str': 'Ruanda language'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",40.0,0.00994919,"After 3 weeks of training, for both the groups, significant improvements in balance and the walking and self-care abilities were noted: The BBS value was significantly increased (P < .05), whereas the TUG, perimeter, and ellipse area with EO and EC measurements were significantly decreased after treatment (P < .05).","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Sino-French Department of Neurological Rehabilitation, Gansu Provincial Hospital, Lanzhou, Gansu, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'You', 'Affiliation': ''}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Weijing', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Shangrong', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022425']
1885,32991589,Effectiveness of a video-based smoking cessation intervention focusing on maternal and child health in promoting quitting among expectant fathers in China: A randomized controlled trial.,"BACKGROUND


Secondhand smoke can cause adverse pregnancy outcomes, yet there is a lack of effective smoking cessation interventions targeted at expectant fathers. We examined the effectiveness of a video-based smoking cessation intervention focusing on maternal and child health in promoting quitting among expectant fathers.
METHODS AND FINDINGS


A single-blind, 3-arm, randomized controlled trial was conducted at the obstetrics registration centers of 3 tertiary public hospitals in 3 major cities (Guangzhou, Shenzhen, and Foshan) in China. Smoking expectant fathers who registered with their pregnant partners were invited to participate in this study. Between 14 August 2017 to 28 February 2018, 1,023 participants were randomized to a video (n = 333), text (n = 322), or control (n = 368) group. The video and text groups received videos or text messages on the risks of smoking for maternal and child health via instant messaging. The control group received a leaflet with information on smoking cessation. Follow-up visits were conducted at 1 week and at 1, 3, and 6 months. The primary outcome, by intention to treat (ITT), was validated abstinence from smoking at the 6-month follow-up. The secondary outcomes included 7-day point prevalence of abstinence (PPA) and level of readiness to quit at each follow-up. The mean age of participants was 32 years, and about half of them were first-time expectant fathers. About two-thirds of participants had completed tertiary education. The response rate was 79.7% (815 of 1,023) at 6 months. The video and text groups had higher rates of validated abstinence than the control group (video group: 22.5% [75 of 333], P < 0.001; text group: 14.9% [48 of 322], P = 0.02; control group: 9.2% [34 of 368]) with adjusted odds ratios (ORs) of 2.80 (95% confidence interval [CI]: 1.79-4.37, P < 0.001) in the video group and 1.70 (95% CI: 1.06-2.74, P = 0.03) in the text group. The video and text groups differed in the rates of validated abstinence (22.5% versus 14.9%, P = 0.008; adjusted OR: 1.64, 95% CI: 1.10-2.46, P = 0.02). The video and text groups had higher rates of 7-day PPA than the control group at 6 months (video group: 24.6% [82 of 333] versus 11.4% [42 of 368], P < 0.001; text group: 17.4% [56 of 333] versus 11.4% [42 of 368], P = 0.02). The video and text groups also differed in the rates of 7-day PPA (24.6% versus 17.4%, P = 0.02). Excluding the quitters, the video and text groups had higher levels of readiness to quit than the control group at 6 months (video group: 43.5% [109 of 251] versus 31.6% [103 of 326], P = 0.002; text group: 40.6% [108 of 266] versus 31.6% [103 of 326], P = 0.01), No such difference was detected between the video and text groups (43.5% versus 40.6%, P = 0.29). The study was limited in that the long-term effectiveness of the intervention is uncertain.
CONCLUSIONS


This smoking cessation intervention for expectant fathers that focused on explaining the ramifications of smoking on maternal and child health was effective and feasible in promoting quitting, and video messages were more effective than texts in delivering the information.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03236025.",2020,"The video and text groups had higher rates of 7-day PPA than the control group at 6 months (video group: 24.6% [82 of 333] versus 11.4% [42 of 368], P < 0.001; text group: 17.4% [56 of 333] versus 11.4% [42 of 368], P = 0.02).","['Between 14 August 2017 to 28 February 2018, 1,023 participants were randomized to a video (n = 333), text (n = 322), or control (n = 368) group', 'obstetrics registration centers of 3 tertiary public hospitals in 3 major cities (Guangzhou, Shenzhen, and Foshan) in China', 'Smoking expectant fathers who registered with their pregnant partners', 'expectant fathers in China', 'expectant fathers']","['videos or text messages on the risks of smoking for maternal and child health via instant messaging', 'video-based smoking cessation intervention', 'leaflet with information on smoking cessation']","['higher rates of 7-day PPA', 'intention to treat (ITT', 'rates of 7-day PPA', '7-day point prevalence of abstinence (PPA) and level of readiness to quit at each follow-up', 'response rate', 'levels of readiness to quit', 'rates of validated abstinence']","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",1023.0,0.124638,"The video and text groups had higher rates of 7-day PPA than the control group at 6 months (video group: 24.6% [82 of 333] versus 11.4% [42 of 368], P < 0.001; text group: 17.4% [56 of 333] versus 11.4% [42 of 368], P = 0.02).","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ho Cheung William', 'Initials': 'HCW', 'LastName': 'Li', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Wenzhi', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Shenzhen hospital, Southern Medical University, Shenzhen, China.'}, {'ForeName': 'Peige', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'School of Public Health, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of gynaecology and obstetrics, Nanhai Hospital Affiliated to Southern Medical University, Foshan, China.'}, {'ForeName': 'Ka Wai Katherine', 'Initials': 'KWK', 'LastName': 'Lam', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Laurie Long Kwan', 'Initials': 'LLK', 'LastName': 'Ho', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ankie Tan', 'Initials': 'AT', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Yuanhui', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Chunxian', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'Clinical Innovation & Research Center (CIRC), Shenzhen Hospital, Southern Medical University, Shenzhen, China.'}, {'ForeName': 'Ka Yan', 'Initials': 'KY', 'LastName': 'Ho', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.'}]",PLoS medicine,['10.1371/journal.pmed.1003355']
1886,32991606,"Efficacy and safety of short-term use of a pelubiprofen CR and aceclofenac in patients with symptomatic knee osteoarthritis: A double-blinded, randomized, multicenter, active drug comparative, parallel-group, phase IV, non-inferiority clinical trial.","INTRODUCTION


At present, information about clinical efficacy and adverse events of controlled release (CR) form of pelubiprofen, a prodrug of 2-arylopropionic acid with relatively selective effects on cyclooxygenase-2 activity, remains scarce. In this study, we sought to determine non-inferiority of pelubiprofen CR 90 mg/day compared to aceclofenac 200 mg/day regarding clinical efficacy and adverse events after a 4-week course of medication in the patients with symptomatic knee osteoarthritis.
MATERIALS AND METHODS


A total of 191 patients were randomly assigned to take either pelubiprofen CR 90 mg (n = 95) or aceclofenac 200 mg (n = 96). The primary outcome variable was non-inferiority of pain reduction between baseline and week 4 when assessed using a 100 mm pain visual analogue scale (VAS). Pelubiprofen was considered non-inferior to aceclofenac if the upper limit of the one-sided 97.5% confidence interval for the difference in terms of pain VAS was above 15 mm (the average change of pain VAS in the pelubiprofen group-pain VAS reduction in the aceclofenac group). Secondary outcome variables were the changes in 100 mm pain VAS at week 2 versus baseline, K-Western Ontario, and McMaster University Arthritis Index (K-WOMAC) changes at weeks 2 and 4 as compared to baseline, patient global assessment at weeks 2 and 4. The frequency and amount of rescue medicine usage at weeks 2 and 4 were also evaluated as the secondary outcome variable. For safety analysis, adverse events, clinical laboratory tests, vital signs, and physical examinations were assessed and conducted at each follow-up visit.
RESULTS


At week 4, the pain VAS values were significantly reduced in both groups receiving either pelubiprofen CR 90 mg or aceclofenac 200 mg as compared to the baseline. However, the pelubiprofen group and the aceclofenac group respectively showed the pain VAS changes of -22 and -21.9 in the pre-protocol set and -20.8 and -21.7 in the full analysis set, confirming non-inferiority. The pelubiprofen CR 90 mg showed a reduced incidence of adverse events compared to the aceclofenac 200 mg (p = 0.005).
CONCLUSIONS


Pelubiprofen CR 90 mg is as effective as aceclofenac 200 mg with reduced adverse events for the treatment of symptomatic knee osteoarthritis.",2020,"The pelubiprofen CR 90 mg showed a reduced incidence of adverse events compared to the aceclofenac 200 mg (p = 0.005).
","['symptomatic knee osteoarthritis', 'A total of 191 patients', 'patients with symptomatic knee osteoarthritis']","['pelubiprofen CR 90 mg/day compared to aceclofenac', 'Pelubiprofen CR', 'pelubiprofen CR', 'pelubiprofen', 'aceclofenac', 'pelubiprofen CR 90 mg or aceclofenac', 'Pelubiprofen', 'pelubiprofen CR and aceclofenac']","['pain visual analogue scale (VAS', 'frequency and amount of rescue medicine usage', 'pain VAS changes', 'For safety analysis, adverse events, clinical laboratory tests, vital signs, and physical examinations', 'adverse events', 'pain VAS values', 'Efficacy and safety', 'pain VAS', 'non-inferiority of pain reduction', 'changes in 100 mm pain VAS at week 2 versus baseline, K-Western Ontario, and McMaster University Arthritis Index (K-WOMAC) changes']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0045712', 'cui_str': 'pelubiprofen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0050403', 'cui_str': 'aceclofenac'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",191.0,0.155177,"The pelubiprofen CR 90 mg showed a reduced incidence of adverse events compared to the aceclofenac 200 mg (p = 0.005).
","[{'ForeName': 'Joung Youp', 'Initials': 'JY', 'LastName': 'Shin', 'Affiliation': 'Department of Orthopaedic Surgery, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Moon Jong', 'Initials': 'MJ', 'LastName': 'Chang', 'Affiliation': 'Department of Orthopaedic Surgery, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Myung Ku', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Inha University Hospital, Incheon, Republic of Korea.'}, {'ForeName': 'Seung-Baik', 'Initials': 'SB', 'LastName': 'Kang', 'Affiliation': 'Department of Orthopaedic Surgery, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kang-Il', 'Initials': 'KI', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Gon', 'Initials': 'HG', 'LastName': 'Park', 'Affiliation': 'Department of Orthopaedic Surgery, Dankook University Hospital, Cheonan-si, Chungcheongnam-do, Republic of Korea.'}, {'ForeName': 'Sahnghoon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sung-Hwan', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Yonsei University College of Medicine, Gangnam Severance Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Beom', 'Initials': 'SB', 'LastName': 'Han', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Han Jun', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Chung-Ang University, School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Wan', 'Initials': 'YW', 'LastName': 'Moon', 'Affiliation': 'Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Doo', 'Initials': 'JD', 'LastName': 'Yoo', 'Affiliation': 'Department of Orthopaedic Surgery, Ewha Womans University School of Medicine, Ewha Medical Research Center, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0238024']
1887,31262489,The SPRINT trial suggests that markers of tubule cell function in the urine associate with risk of subsequent acute kidney injury while injury markers elevate after the injury.,"Urine markers can quantify tubular function including reabsorption (α-1 microglobulin [α1m]) and β-2-microglobulin [β2m]) and protein synthesis (uromodulin). Individuals with tubular dysfunction may be less able to compensate to insults than those without, despite similar estimated glomerular filtration rate (eGFR) and albuminuria. Among Systolic Blood Pressure Intervention Trial (SPRINT) participants with an eGFR under 60 ml/min/1.73m 2 , we measured urine markers of tubular function and injury (neutrophil gelatinase-associated lipocalin [NGAL], kidney injury molecule-1 [KIM-1], interleukin-18 [IL-18], monocyte chemoattractant protein-1, and chitinase-3-like protein [YKL-40]) at baseline. Cox models evaluated associations with subsequent acute kidney injury (AKI) risk, adjusting for clinical risk factors, baseline eGFR and albuminuria, and the tubular function and injury markers. In a random subset, we remeasured biomarkers after four years, and compared changes in biomarkers in those with and without intervening AKI. Among 2351 participants, 184 experienced AKI during 3.8 years mean follow-up. Lower uromodulin (hazard ratio per two-fold higher (0.68, 95% confidence interval [0.56, 0.83]) and higher α1m (1.20; [1.01, 1.44]) were associated with subsequent AKI, independent of eGFR and albuminuria. None of the five injury markers were associated with eventual AKI. In the random subset of 947 patients with repeated measurements, the 59 patients with intervening AKI versus without had longitudinal increases in urine NGAL, IL-19, and YKL-40 and only 1 marker of tubule function (α1m). Thus, joint evaluation of tubule function and injury provided novel insights to factors predisposing to AKI, and responses to kidney injury.",2019,"Individuals with tubular dysfunction may be less able to compensate to insults than those without, despite similar estimated glomerular filtration rate (eGFR) and albuminuria.","['947 patients with repeated measurements, the 59 patients with intervening AKI', 'Individuals with tubular dysfunction', '2351 participants, 184 experienced AKI during 3.8 years mean follow-up']",[],"['tubular function including reabsorption (α-1 microglobulin [α1m]) and β-2-microglobulin [β2m]) and protein synthesis (uromodulin', 'urine NGAL, IL-19, and YKL-40 and only 1 marker of tubule function (α1m', 'eventual AKI', 'acute kidney injury (AKI) risk, adjusting for clinical risk factors, baseline eGFR and albuminuria, and the tubular function and injury markers', 'urine markers of tubular function and injury (neutrophil gelatinase-associated lipocalin [NGAL], kidney injury molecule-1 [KIM-1], interleukin-18 [IL-18], monocyte chemoattractant protein-1, and chitinase-3-like protein [YKL-40', 'glomerular filtration rate (eGFR) and albuminuria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],"[{'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0597295', 'cui_str': 'Genetic translation'}, {'cui': 'C0077918', 'cui_str': 'Uromucoid protein'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0215955', 'cui_str': 'LCN2 protein, human'}, {'cui': 'C1447896', 'cui_str': 'IL19 protein, human'}, {'cui': 'C0528649', 'cui_str': 'CHI3L1 protein, human'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C1313407', 'cui_str': 'HAVCR1 protein, human'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0008145', 'cui_str': 'Chitinase'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",2351.0,0.206763,"Individuals with tubular dysfunction may be less able to compensate to insults than those without, despite similar estimated glomerular filtration rate (eGFR) and albuminuria.","[{'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Bullen', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Lee', 'Affiliation': 'Kidney Health Research Collaborative, Department of Medicine, University of California, San Francisco, California, USA.'}, {'ForeName': 'Cheryl A M', 'Initials': 'CAM', 'LastName': 'Anderson', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, California, USA; Division of Preventive Medicine, Department of Family Medicine and Public Health, University of California-San Diego, San Diego, California, USA.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Division of Nephrology & Hypertension, Department of Internal Medicine, University of Utah, Salt Lake City, Utah, USA; Medical Service, Veterans Affairs, Salt Lake City Healthcare System, Salt Lake City, Utah, USA.'}, {'ForeName': 'Pranav S', 'Initials': 'PS', 'LastName': 'Garimella', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Vasantha', 'Initials': 'V', 'LastName': 'Jotwani', 'Affiliation': 'Department of Medicine, San Francisco VA Medical Center, San Francisco, California, USA; Department of Epidemiology and Biostatistics, University of California, San Francisco, California, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Areef', 'Initials': 'A', 'LastName': 'Ishani', 'Affiliation': 'Division of Medicine, Minneapolis Veterans Affairs Health Care System, Minneapolis, Minnesota, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Lash', 'Affiliation': 'Division of Nephrology, Department of Medicine, College of Medicine, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Javier A', 'Initials': 'JA', 'LastName': 'Neyra', 'Affiliation': 'Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky Medical Center, Lexington, Kentucky, USA; Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern, Dallas, Texas, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Punzi', 'Affiliation': 'UT Southwestern Medical Center, Carrollton, Texas, USA.'}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine, David Geffen School of Medicine, University of California Los Angeles (UCLA), Los Angeles, California, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Riessen', 'Affiliation': 'Medical Service, Veterans Affairs, Salt Lake City Healthcare System, Salt Lake City, Utah, USA.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Chirag R', 'Initials': 'CR', 'LastName': 'Parikh', 'Affiliation': 'Department of Medicine, Section of Nephrology, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Barry M', 'Initials': 'BM', 'LastName': 'Wall', 'Affiliation': 'Division of Nephrology, Veterans Affairs Medical Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Udayan Y', 'Initials': 'UY', 'LastName': 'Bhatt', 'Affiliation': 'Division of Nephrology, The Ohio State University, Wexner Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'Kidney Health Research Collaborative, Department of Medicine, University of California, San Francisco, California, USA; Department of Medicine, San Francisco VA Medical Center, San Francisco, California, USA.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, California, USA; Nephrology Section, Veterans Affairs, San Diego Healthcare System, La Jolla, California, USA.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Estrella', 'Affiliation': 'Kidney Health Research Collaborative, Department of Medicine, University of California, San Francisco, California, USA; Department of Medicine, San Francisco VA Medical Center, San Francisco, California, USA. Electronic address: michelle.estrella@ucsf.edu.'}]",Kidney international,['10.1016/j.kint.2019.03.024']
1888,33002283,Postinflammatory and rebound hyperpigmentation as a complication after treatment efficacy of telangiectatic melasma with 585 nanometers Q-switched Nd: YAG laser and 4% hydroquinone cream in skin phototypes III-V.,"BACKGROUND


The potential efficacy of vascular component-targeted laser has been evaluated for the treatment of melasma, which commonly found with the co-existence of telangiectasia.
AIMS


To evaluate the treatment efficacy and safety of 585-nm QSNYL and 4% HQ cream combination vs 4% HQ cream alone for telangiectatic melasma in the skin phototypes III-V.
PATIENTS/METHODS


Twenty-one Thai female patients with telangiectatic melasma and Fitzpatrick skin phototypes (FPTs) III-V were randomly treated with the 585-nm QSNYL on one side of the face for five sessions at 2-week intervals. All patients were assigned to apply HQ cream daily at night on both sides of the face for 10 weeks and a broad-spectrum sunscreen regularly throughout the study. The treatment efficacy and safety were evaluated using the Modified Melasma Area and Severity Index (mMASI), biometric evaluation, patient assessment, and adverse effects.
RESULTS


The combination-treated side yielded more significant improvement of mMASI than the topical-treated side at weeks 2, 4, and 8, respectively. However, 19% of the patients developed postinflammatory hyperpigmentation (PIH) on the laser-treated side, especially in FPTs IV-V and rebound hyperpigmentation. There was a significant improvement of hemoglobin and melanin index, but without statistical difference between the two treatment groups.
CONCLUSIONS


The combination of 585-nm QSNYL and HQ treatment yields treatment efficacy and skin rejuvenation effects for telangiectatic melasma. Nonetheless, a high incidence of PIH and rebound hyperpigmentation is adversely developed in dark FPT. Thus, this laser treatment should be cautiously applied in those with dark FPTs IV-V to avoid laser-induced pigment alteration.",2020,The combination of 585-nm QSNYL and HQ treatment yields treatment efficacy and skin rejuvenation effects for telangiectatic melasma.,"['Twenty-one Thai female patients with telangiectatic melasma and Fitzpatrick skin phototype (FPT) III-V', 'Skin Phototype III-V', 'telangiectatic melasma']","['vascular component-targeted laser', '585-nm QSNYL and 4% HQ cream combination versus 4% HQ cream alone', 'telangiectatic melasma with 585 nanometers Q-switched Nd: YAG laser and 4% hydroquinone cream', 'HQ cream']","['treatment efficacy and safety', 'Modified Melasma Area and Severity Index (mMASI), biometric evaluation, patient assessment, and adverse effects', 'mMASI', 'post-inflammatory hyperpigmentation (PIH', 'hemoglobin and melanin index']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0439202', 'cui_str': 'nm'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C1252137', 'cui_str': 'hydroquinone Topical Cream'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}]",21.0,0.0146642,The combination of 585-nm QSNYL and HQ treatment yields treatment efficacy and skin rejuvenation effects for telangiectatic melasma.,"[{'ForeName': 'Suparuj', 'Initials': 'S', 'LastName': 'Lueangarun', 'Affiliation': 'Division of Dermatology, Chulabhorn International College of Medicine, Thammasat University, Pathumthani, Thailand.'}, {'ForeName': 'Chutimon', 'Initials': 'C', 'LastName': 'Namboonlue', 'Affiliation': 'Division of Dermatology, Chulabhorn International College of Medicine, Thammasat University, Pathumthani, Thailand.'}, {'ForeName': 'Therdpong', 'Initials': 'T', 'LastName': 'Tempark', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13756']
1889,32985775,Withdrawal of medications leads to worsening of OGTT parameters in youth with impaired glucose tolerance or recently-diagnosed type 2 diabetes.,"BACKGROUND


The RISE Pediatric Medication Study compared strategies for preserving β-cell function, including a 9-month follow-up after treatment withdrawal to test treatment effect durability.
OBJECTIVE


Evaluate OGTT measures of glucose and β-cell response through 12 months of intervention and 9 months of medication washout.
PARTICIPANTS


Youth (n = 91) aged 10 to 19 years with BMI ≥85th percentile and impaired glucose tolerance (IGT) or recently diagnosed type 2 diabetes (T2D).
METHODS


A multicenter randomized clinical trial comparing insulin glargine for 3 months followed by metformin for 9 months (G→Met) or metformin alone (Met) for 12 months. We report within-group changes from baseline to end of medication intervention (M12), baseline to 9 months post-medication withdrawal (M21), and end of medication (M12) to M21. OGTT C-peptide index [CPI] paired with 1/fasting insulin evaluated β-cell response.
RESULTS


At M12, both treatments were associated with stable fasting glucose (G→Met baseline 6.0 ± 0.1 vs M12 5.9 ± 0.2 mmol/L, P = .62; Met baseline 6.1 ± 0.2 vs M12 6.0 ± 0.2 mmol/L, P = .73) and 2-hour glucose (G→Met baseline 10.2 ± 0.4 vs M12 9.3 ± 0.5 mmol/L, P = .03; Met baseline 10.2 ± 0.4 vs M12 10.6 ± 0.6 mmol/L, P = .88). Following medication withdrawal, fasting glucose worsened (G→Met M21 8.6 ± 1.8, P = .004; Met M21 7.8 ± 0.7 mmol/L, P = .003), as did 2-hour glucose (G→Met M21 13.2 ± 1.4, P = .002; Met M21 13.1 ± 1.2 mmol/L, P = .006), associated with declines in β-cell response.
CONCLUSIONS


G→Met and Met were associated with stable glucose measures during 12 months of treatment in youth with IGT or recently diagnosed T2D. Glucose and β-cell response worsened post-medication withdrawal, suggesting treatment must be long-term or alternative treatments pursued.",2020,"Following medication withdrawal, fasting glucose worsened (G→Met M21 8.6±1.8, p=0.004; Met M21 7.8±0.7 mmol/L, p=0.003), as did 2-hour glucose (G→Met M21 13.2±1.4, p=0.002; Met M21 13.1±1.2 mmol/L, p=0.006), associated with declines in β-cell response.
","['Youth (n=91) aged 10-19\u2009years with BMI ≥85th percentile and impaired glucose tolerance (IGT) or recently diagnosed type 2 diabetes (T2D', 'Youth with Impaired Glucose Tolerance or Recently-Diagnosed Type 2 Diabetes']","['insulin glargine', 'metformin']","['stable fasting glucose', 'fasting glucose', 'glucose and β-cell response', 'stable glucose measures', 'β-cell response']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",91.0,0.022497,"Following medication withdrawal, fasting glucose worsened (G→Met M21 8.6±1.8, p=0.004; Met M21 7.8±0.7 mmol/L, p=0.003), as did 2-hour glucose (G→Met M21 13.2±1.4, p=0.002; Met M21 13.1±1.2 mmol/L, p=0.006), associated with declines in β-cell response.
","[{'ForeName': 'Tamara S', 'Initials': 'TS', 'LastName': 'Hannon', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Edelstein', 'Affiliation': 'George Washington University Biostatistics Center, Rockville, Maryland, USA.'}, {'ForeName': 'Silva A', 'Initials': 'SA', 'LastName': 'Arslanian', 'Affiliation': ""University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Caprio', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Zeitler', 'Affiliation': ""University of Colorado Anschutz Medical Campus, Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Buchanan', 'Affiliation': 'University of Southern California, Keck School of Medicine, Los Angeles, California, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ehrmann', 'Affiliation': 'University of Chicago, Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tripputi', 'Affiliation': 'George Washington University Biostatistics Center, Rockville, Maryland, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'VA Puget Sound Health Care System and University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': ""University of Colorado Anschutz Medical Campus, Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric diabetes,['10.1111/pedi.13129']
1890,32980384,Postoperative radiotherapy with intensity-modulated radiation therapy versus 3-dimensional conformal radiotherapy in early breast cancer: A randomized clinical trial of KROG 15-03.,"PURPOSE


To investigate the safety and efficacy of intensity-modulated radiation therapy (IMRT) for early breast cancer compared with 3-dimensional conformal radiotherapy (3D-CRT) in a prospective and randomized trial.
METHODS AND MATERIALS


From March 2015 to February 2018, 693 patients with pT1-2N0M0 early breast cancer who underwent breast-conserving surgery were enrolled and randomly assigned into IMRT and 3D-CRT. The primary endpoint was 3-year locoregional recurrence-free survival (LRRFS). The secondary endpoints were recurrence-free survival, overall survival, acute toxicity, target coverage index, irradiation dose to organs at risk, and fatigue inventory. The radiation dose for the 3D-CRT arm was 59.4 Gy in 33 fractions for 6.5 weeks. It was 57.4 Gy in 28 fractions with simultaneous integrated boost for 5.5 weeks for the IMRT arm.
RESULTS


Of 693 patients, 349 and 344 patients received 3D-CRT and IMRT, respectively. There was no significant difference in LRRFS between the two arms. Conformity index of planning target volume was significantly superior in the IMRT arm than the 3D-CRT arm (p < 0.001). The mean lung dose and V 5 -V 50  for the ipsilateral lung were significantly lower in the IMRT arm than the 3D-CRT arm (all p < 0.05). The incidence of grade 2 or higher dermatitis was significantly lower in the IMRT arm (p = 0.009).
CONCLUSION


Compared to 3D-CRT, IMRT showed similar results in locoregional tumor control but superior results in planning target volume coverage. When IMRT is used in breast cancer, the irradiation dose to an ipsilateral lung and skin toxicity can be reduced.",2020,"Compared to 3D-CRT, IMRT showed similar results in locoregional tumor control but superior results in planning target volume coverage.","['693 patients', '349 and 344 patients received', 'From March 2015 to February 2018, 693 patients with pT1-2N0M0 early breast cancer who underwent breast-conserving surgery', 'early breast cancer']","['3D-CRT and IMRT', 'IMRT', '3-dimensional conformal radiotherapy (3D-CRT', 'IMRT and 3D-CRT', 'Postoperative radiotherapy with intensity-modulated radiation therapy versus 3-dimensional conformal radiotherapy', 'intensity-modulated radiation therapy (IMRT']","['Conformity index of planning target volume', 'incidence of grade 2 or higher dermatitis', 'LRRFS', '3-year locoregional recurrence-free survival (LRRFS', 'mean lung dose and V 5 -V 50  for the ipsilateral lung', 'recurrence-free survival, overall survival, acute toxicity, target coverage index, irradiation dose to organs at risk, and fatigue inventory']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332391', 'cui_str': 'pT1 category'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0454199', 'cui_str': 'Planning target volume'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C2936599', 'cui_str': 'Organs at Risk'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",693.0,0.0805317,"Compared to 3D-CRT, IMRT showed similar results in locoregional tumor control but superior results in planning target volume coverage.","[{'ForeName': 'Kyu Hye', 'Initials': 'KH', 'LastName': 'Choi', 'Affiliation': ""Department of Radiation Oncology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Sung Ja', 'Initials': 'SJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Radiation Oncology, Chonnam National University Hospital, Chonnam National University School of Medicine, Gwangju, Republic of Korea.'}, {'ForeName': 'Jae Uk', 'Initials': 'JU', 'LastName': 'Jeong', 'Affiliation': 'Department of Radiation Oncology, Chonnam National University Hospital, Chonnam National University School of Medicine, Gwangju, Republic of Korea.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': ""Department of Radiation Oncology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Bae Kwon', 'Initials': 'BK', 'LastName': 'Jeong', 'Affiliation': 'Department of Radiation Oncology, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Republic of Korea.'}, {'ForeName': 'Joo Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ""Department of Radiation Oncology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Sung Hwan', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': ""Department of Radiation Oncology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jong Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ""Department of Radiation Oncology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: koppul@catholic.ac.kr.""}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.09.043']
1891,32980586,Desire to drink as a function of laboratory-induced social stress among adolescents.,"BACKGROUND AND OBJECTIVES


Research consistently demonstrates a link between social anxiety and alcohol-related problems; however, the majority of work has been retrospective, and conducted with adults. Despite an extensive literature highlighting coping-related motives as an underlying mechanism, real-time work presents mixed findings, and no published research has examined an adolescent sample using experimental psychopathology techniques.
METHODS


The current study tested whether (1) history of social anxiety symptoms positively correlated with alcohol-related cognitions following laboratory-induced social stress, (2) state anxiety was positively correlated with alcohol-related cognitions, and (3) whether the nature of the stressor (performance versus rejection) impacted the strength of identified relations, in a sample of community-recruited adolescents reporting recent alcohol use. Participants (n = 114; M age  = 16.01; 64% girls) were randomly assigned to either a performance- or rejection-oriented task.
RESULTS


Findings indicated that history of social anxiety symptoms was positively correlated with state anxiety elicited by both tasks. Further, history of social anxiety symptoms was not related to change in desire to drink, but was positively related to the belief that alcohol 'would make me feel better.' State anxiety was positively related to both desire to drink and relief outcome expectancies across both tasks. Finally, the nature of the task did not moderate responding.
LIMITATIONS


Single site, community sampling confines interpretations, and the tasks did not fully perform as expected.
CONCLUSIONS


Further study is needed; however, the current findings support the contention that socially-oriented distress may be a developmentally-relevant, malleable target for prevention efforts aimed at problematic alcohol use among adolescents.",2020,State anxiety was positively related to both desire to drink and relief outcome expectancies across both tasks.,"['114; M age \xa0=\xa016.01; 64% girls', 'adolescents', 'Participants (n\xa0']",['performance- or rejection-oriented task'],"['history of social anxiety symptoms', 'State anxiety']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}]","[{'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}]",,0.0194071,State anxiety was positively related to both desire to drink and relief outcome expectancies across both tasks.,"[{'ForeName': 'Heidemarie', 'Initials': 'H', 'LastName': 'Blumenthal', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: heidemarie.blumenthal@unt.edu.'}, {'ForeName': 'Renee M', 'Initials': 'RM', 'LastName': 'Cloutier', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: ReneeCloutier@my.unt.edu.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Douglas', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: MeganDouglas@my.unt.edu.'}, {'ForeName': 'Nathan T', 'Initials': 'NT', 'LastName': 'Kearns', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: NathanKearns@my.unt.edu.'}, {'ForeName': 'Caitlyn N', 'Initials': 'CN', 'LastName': 'Carey', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: CaitlynCarey@my.unt.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101617']
1892,32988938,Comparing responses to public health and industry-funded alcohol harm reduction advertisements: an experimental study.,"OBJECTIVES


Conduct a head-to-head experimental test of responses to alcohol harm reduction advertisements developed by alcohol industry Social Aspects/Public Relations Organisations (SAPROs) versus those developed by public health (PH) agencies. We hypothesised that, on average, SAPRO advertisements would be less effective at generating motivation (H1) and intentions to reduce alcohol consumption (H2) but more effective at generating positive perceptions of people who drink (H3).
DESIGN


Online experiment with random assignment to condition.
PARTICIPANTS


2923 Australian adult weekly drinkers (49% high-risk drinkers) recruited from an opt-in online panel.
INTERVENTIONS


Participants viewed 3 of 83 advertisements developed by PH agencies (n=2174) or 3 of 28 advertisements developed by SAPROs (n=749).
PRIMARY OUTCOME MEASURES


Participants reported their motivation to reduce the amount of alcohol consumed; behave responsibly and/or not get drunk; and limit their drinking around/never supply to minors, as well as intentions to avoid drinking alcohol completely; reduce the number of drinking occasions; and reduce the amount of alcohol consumed per occasion. Participants also reported their perceptions of people who drink alcohol on six success-related items and four fun-related items.
RESULTS


Compared with drinkers exposed to PH advertisements, those exposed to SAPRO advertisements reported lower motivation to reduce the amount of alcohol consumed (β=-0.091, 95% CI -0.171 to -0.010), and lower odds of intending to avoid alcohol completely (OR=0.77, 0.63 to 0.94) and to reduce the amount of alcohol consumed per occasion (OR=0.82, 0.69 to 0.97). SAPRO advertisements generated more favourable fun-related perceptions of drinkers (β=0.095, 0.013 to 0.177).
CONCLUSIONS


The alcohol harm reduction advertisements produced by alcohol industry SAPROs that were tested in this study were not as effective at generating motivation and intentions to reduce alcohol consumption as those developed by PH organisations. These findings raise questions as to whether SAPROs should play a role in alcohol harm reduction efforts.",2020,"SAPRO advertisements generated more favourable fun-related perceptions of drinkers (β=0.095, 0.013 to 0.177).
","['n=2174) or 3 of 28 advertisements developed by SAPROs (n=749', '2923 Australian adult weekly drinkers (49% high-risk drinkers) recruited from an opt-in online panel']","['public health and industry-funded alcohol harm reduction advertisements', 'Participants viewed 3 of 83 advertisements developed by PH agencies']",['number of drinking occasions'],"[{'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]","[{'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0679771', 'cui_str': 'Harm Minimization'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0449911', 'cui_str': 'View'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",2923.0,0.0321565,"SAPRO advertisements generated more favourable fun-related perceptions of drinkers (β=0.095, 0.013 to 0.177).
","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Brennan', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia emily.brennan@cancervic.org.au.'}, {'ForeName': 'Danielle A J M', 'Initials': 'DAJM', 'LastName': 'Schoenaker', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Durkin', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Dunstone', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Helen G', 'Initials': 'HG', 'LastName': 'Dixon', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Slater', 'Affiliation': 'School of Communication, Ohio State University, Columbus, Ohio, United States.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Pettigrew', 'Affiliation': 'George Institute for Global Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Wakefield', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-035569']
1893,32988951,"Multicentre, single-blind randomised controlled trial comparing MyndMove neuromodulation therapy with conventional therapy in traumatic spinal cord injury: a protocol study.","INTRODUCTION


This protocol is describing a multicentre, single-blind randomised controlled trial. The objective is to compare the efficacy of MyndMove therapy versus conventional therapy (CT) in improving upper extremity function in individuals with C4-C7 traumatic, incomplete spinal cord injury (SCI). It is being conducted in two US and two Canadian SCI rehabilitation centres.
METHODS AND ANALYSIS


Sixty people aged 18 years or older with a C4-C7 incomplete (AIS B-D) SCI between 4 months and 8 years postinjury are randomised to receive 40 sessions of MyndMove neuromodulation therapy or CT within a 14-week period of time. Therapy sessions are 1 hour in duration with a dose of 3-5 sessions per week. Assessments occur prior to randomisation, after 20 sessions, after 40 sessions and 10 weeks after the last session. The primary outcome measure is the efficacy of MyndMove therapy versus CT in improving upper extremity function as measured by Spinal Cord Independence Measure III: Self-Care subscore after 40 sessions. Secondary outcomes include: (1) improvements in the SCIM mobility subscore; (2) upper limb functions measured by Graded Redefined Assessment of Strength, Sensibility and Prehension and (3) Toronto Rehab Institute Hand Function Test; (4) To assess safety as measured by serious and non-serious adverse events recorded for participants in both groups of the study population over the duration of the study; (5) to compare the change in quality of life as measured by the Spinal Cord Injury-Quality of Life; and (6) to evaluate the impact on healthcare resource utilisation.
ETHICS AND DISSEMINATION


All ethical approvals were obtained prior to enrolling any participants. Dissemination of the results of the study will be made at peer-reviewed academic meetings and through peer-reviewed medical journals TRIAL REGISTRATION NUMBER: NCT03439319.",2020,"Secondary outcomes include: (1) improvements in the SCIM mobility subscore; (2) upper limb functions measured by Graded Redefined Assessment of Strength, Sensibility and Prehension and (3) Toronto Rehab Institute Hand Function Test; (4) To assess safety as measured by serious and non-serious adverse events recorded for participants in both groups of the study population over the duration of the study; (5) to compare the change in quality of life as measured by the Spinal Cord Injury-Quality of Life; and (6) to evaluate the impact on healthcare resource utilisation.
ETHICS AND DISSEMINATION


","['Sixty people aged 18 years or older with a C4-C7 incomplete (AIS B-D) SCI between 4 months and 8 years postinjury', 'traumatic spinal cord injury', 'individuals with C4-C7 traumatic, incomplete spinal cord injury (SCI']","['MyndMove therapy versus conventional therapy (CT', 'MyndMove neuromodulation therapy or CT', 'conventional therapy', 'MyndMove neuromodulation therapy']","[' (1) improvements in the SCIM mobility subscore; (2) upper limb functions measured by Graded Redefined Assessment of Strength, Sensibility and Prehension and (3) Toronto Rehab Institute Hand Function Test; (4) To assess safety as measured by serious and non-serious adverse events', 'efficacy of MyndMove therapy versus CT in improving upper extremity function as measured by Spinal Cord Independence Measure III: Self-Care subscore', 'quality of life as measured by the Spinal Cord Injury-Quality of Life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0039585', 'cui_str': 'Androgen resistance syndrome'}, {'cui': 'C0763303', 'cui_str': ""N-bis(1-hydroxy-2-oxopropyl)-2'-deoxyguanosine""}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]",60.0,0.134899,"Secondary outcomes include: (1) improvements in the SCIM mobility subscore; (2) upper limb functions measured by Graded Redefined Assessment of Strength, Sensibility and Prehension and (3) Toronto Rehab Institute Hand Function Test; (4) To assess safety as measured by serious and non-serious adverse events recorded for participants in both groups of the study population over the duration of the study; (5) to compare the change in quality of life as measured by the Spinal Cord Injury-Quality of Life; and (6) to evaluate the impact on healthcare resource utilisation.
ETHICS AND DISSEMINATION


","[{'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Anderson', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, MetroHealth System, Cleveland, Ohio, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Wilson', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, MetroHealth System, Cleveland, Ohio, USA.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Korupolu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Pierce', 'Affiliation': 'Centre for Neurology Studies, Health Tech Connex, Surrey, British Columbia, Canada.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Bowen', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Daria', 'Initials': 'D', 'LastName': ""O'Reilly"", 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Naaz', 'Initials': 'N', 'LastName': 'Kapadia', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Milos R', 'Initials': 'MR', 'LastName': 'Popovic', 'Affiliation': 'The KITE Research Institute, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'Musselman', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada Kristin.Musselman@uhn.ca.'}]",BMJ open,['10.1136/bmjopen-2020-039650']
1894,32988954,Contamination and washing of cloth masks and risk of infection among hospital health workers in Vietnam: a post hoc analysis of a randomised controlled trial.,"BACKGROUND


In a previous randomised controlled trial (RCT) in hospital healthcare workers (HCWs), cloth masks resulted in a higher risk of respiratory infections compared with medical masks. This was the only published RCT of cloth masks at the time of the COVID-19 pandemic.
OBJECTIVE


To do a post hoc analysis of unpublished data on mask washing and mask contamination from the original RCT to further understand poor performance of the two-layered cotton cloth mask used by HCWs in that RCT.
SETTING


14 secondary-level/tertiary-level hospitals in Hanoi, Vietnam.
PARTICIPANTS


A subgroup of 607 HCWs aged ≥18 years working full time in selected high-risk wards, who used a two-layered cloth mask and were part of a randomised controlled clinical trial comparing medical masks and cloth masks.
INTERVENTION


Washing method for cloth masks (self-washing or hospital laundry). A substudy of contamination of a sample of 15 cloth and medical masks was also conducted.
OUTCOME MEASURE


Infection rate over 4 weeks of follow up and viral contamination of masks tested by multiplex PCR.
RESULTS


Viral contamination with rhinovirus was identified on both used medical and cloth masks. Most HCW (77% of daily washing) self-washed their masks by hand. The risk of infection was more than double among HCW self-washing their masks compared with the hospital laundry (HR 2.04 (95% CI 1.03 to 4.00); p=0.04). There was no significant difference in infection between HCW who wore cloth masks washed in the hospital laundry compared with medical masks (p=0.5).
CONCLUSIONS


Using self-reported method of washing, we showed double the risk of infection with seasonal respiratory viruses if masks were self-washed by hand by HCWs. The majority of HCWs in the study reported hand-washing their mask themselves. This could explain the poor performance of two layered cloth masks, if the self-washing was inadequate. Cloth masks washed in the hospital laundry were as protective as medical masks. Both cloth and medical masks were contaminated, but only cloth masks were reused in the study, reiterating the importance of daily washing of reusable cloth masks using proper method. A well-washed cloth mask can be as protective as a medical mask.
TRIAL RESGISTRATION NUMBER


ACTRN12610000887077.",2020,"There was no significant difference in infection between HCW who wore cloth masks washed in the hospital laundry compared with medical masks (p=0.5).
","['hospital healthcare workers (HCWs', 'hospital health workers in Vietnam', '14 secondary-level/tertiary-level hospitals in Hanoi, Vietnam', 'A subgroup of 607 HCWs aged ≥18\u2009years working full time in selected high-risk wards, who used a two-layered cloth mask and were part of a randomised controlled clinical trial comparing medical masks and cloth masks']",['Washing method for cloth masks (self-washing or hospital laundry'],"['Infection rate', 'risk of infection', 'infection']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",607.0,0.072564,"There was no significant difference in infection between HCW who wore cloth masks washed in the hospital laundry compared with medical masks (p=0.5).
","[{'ForeName': 'Chandini Raina', 'Initials': 'CR', 'LastName': 'MacIntyre', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia rainam@protonmail.com.'}, {'ForeName': 'Tham Chi', 'Initials': 'TC', 'LastName': 'Dung', 'Affiliation': 'Ministry of Health, Vietnam, Hanoi, Viet Nam.'}, {'ForeName': 'Abrar Ahmad', 'Initials': 'AA', 'LastName': 'Chughtai', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Seale', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bayzidur', 'Initials': 'B', 'LastName': 'Rahman', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-042045']
1895,32986682,The D1/D5 Dopamine Partial Agonist PF-06412562 in Advanced-Stage Parkinson's Disease: A Feasibility Study.,"BACKGROUND


Current drug treatments have little efficacy in advanced-to-end-stage Parkinson's disease (advPD), yet there are no reports of interventional trials in advPD. D1 dopamine agonists have the potential to provide benefit.
OBJECTIVE


To determine the feasibility and safety of the selective D1/D5 dopamine partial agonist PF 06412562 in advPD.
METHODS


A two-week, randomized, double blind, crossover phase Ib study in advPD patients compared standard-of-care (SoC) carbidopa/levodopa with PF 06412562. Each week, there was a Day 1 baseline evaluation with overnight levodopa washout, then treatment on Days 2 and 3 with either SoC or PF-06412562 (split dose 25 + 20 mg), followed by discharge on Day 4. Primary endpoints were safety and tolerability. Secondary endpoints were global clinical impression of change (GCI-C) rated by clinicians and caregivers.
RESULTS


Eight advPD patients and their caregivers consented to participate and six were randomized (average disease duration: 22 y). None withdrew voluntarily. One participant with baseline Day 1 dehydration, pre-renal kidney injury, and autonomic dysfunction experienced symptomatic and serious hypotension after receiving PF-06412562 in Week 1 and was discontinued from the study. All other adverse events were rated mild (PF-06412562: n = 1, SoC: n = 0), moderate (PF-06412562: n = 1, SoC: n = 1), or severe but non-serious (PF-06412562: n = 3, SoC: n = 2). No clinically meaningful laboratory changes were observed. Among the five participants who completed the study, GCI-C favored PF-06412562 in two per clinicians' and four participants per caregivers' rating.
CONCLUSION


PF-06412562 was tolerated in advPD patients. This study provides the feasibility for future safety and efficacy studies in this population with unmet needs.",2020,No clinically meaningful laboratory changes were observed.,"['Eight advPD patients and their caregivers consented to participate and six were randomized (average disease duration: 22\u200ay', ""Advanced-Stage Parkinson's Disease"", 'advPD patients']","['SoC or PF-06412562', 'D1/D5 Dopamine Partial Agonist PF-06412562', 'PF-06412562', 'standard-of-care (SoC) carbidopa/levodopa with PF 06412562']","['safety and tolerability', 'renal kidney injury, and autonomic dysfunction experienced symptomatic and serious hypotension', 'global clinical impression of change (GCI-C) rated by clinicians and caregivers']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4049471', 'cui_str': ""End stage Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}, {'cui': 'C0013363', 'cui_str': 'Dysautonomia'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",,0.156913,No clinically meaningful laboratory changes were observed.,"[{'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Departments of Neurology, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Mechelle M', 'Initials': 'MM', 'LastName': 'Lewis', 'Affiliation': 'Departments of Neurology, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Lauren Jodi', 'Initials': 'LJ', 'LastName': 'Van Scoy', 'Affiliation': 'Departments of Medicine, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Sol', 'Initials': 'S', 'LastName': 'De Jesus', 'Affiliation': 'Departments of Neurology, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Eslinger', 'Affiliation': 'Departments of Neurology, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Arnold', 'Affiliation': 'Departments of Neural and Behavioral Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Miller', 'Affiliation': 'Departments of Neural and Behavioral Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Fernandez-Mendoza', 'Affiliation': 'Departments of Neural and Behavioral Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Snyder', 'Affiliation': 'Departments of Neurology, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Harrington', 'Affiliation': 'Departments of Neurology, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Kong', 'Affiliation': 'Departments of Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Departments of Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Dongxiao', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Departments of Pharmacology, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Delnomdedieu', 'Affiliation': 'Pfizer Inc., Cambridge, MA, USA.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Duvvuri', 'Affiliation': 'Cerevel Neurosciences LLC., Boston, MA, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Mahoney', 'Affiliation': 'Pfizer Inc., Cambridge, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gray', 'Affiliation': 'Cerevel Neurosciences LLC., Boston, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Mailman', 'Affiliation': 'Departments of Neurology, Penn State College of Medicine, Hershey, PA, USA.'}]",Journal of Parkinson's disease,['10.3233/JPD-202188']
1896,32991355,Conversion of Propranolol to Carvedilol Improves Renal Perfusion and Outcome in Patients With Cirrhosis and Ascites.,"BACKGROUND


In recent years, concerns have been raised on the potential adverse effects of nonselective beta-blockers, and particularly carvedilol, on renal perfusion and survival in decompensated cirrhosis with ascites. We investigated the long-term impact of converting propranolol to carvedilol on systemic hemodynamics and renal function, and on the outcome of patients with stable cirrhosis and grade II/III nonrefractory ascites.
PATIENTS AND METHODS


Ninety-six patients treated with propranolol for esophageal varices' bleeding prophylaxis were prospectively evaluated. These patients were randomized in a 2:1 ratio to switch to carvedilol at 12.5 mg/d (CARVE group; n=64) or continue propranolol (PROPRA group; n=32). Systemic vascular resistance, vasoactive factors, glomerular filtration rate, and renal blood flow were evaluated at baseline before switching to carvedilol and after 6 and 12 months. Further decompensation and survival were evaluated at 2 years.
RESULTS


During a 12-month follow-up, carvedilol induced an ongoing improvement of systemic vascular resistance (1372±34 vs. 1254±33 dynes/c/cm; P=0.02) along with significant decreases in plasma renin activity (4.05±0.66 vs. 6.57±0.98 ng/mL/h; P=0.01) and serum noradrenaline (76.7±8.2 vs. 101.9±10.5 pg/mL; P=0.03) and significant improvement of glomerular filtration rate (87.3±2.7 vs. 78.7±2.3 mL/min; P=0.03) and renal blood flow (703±17 vs. 631±12 mL/min; P=0.03); no significant effects were noted in the PROPRA group. The 2-year occurrence of further decompensation was significantly lower in the CARVE group than in the PROPRA group (10.5% vs. 35.9%; P=0.003); survival at 2 years was significantly higher in the CARVE group (86% vs. 64.1%; P=0.01, respectively).
CONCLUSION


Carvedilol at the dose of 12.5 mg/d should be the nonselective beta-blocker treatment of choice in patients with cirrhosis and nonrefractory ascites, as it improves renal perfusion and outcome.",2020,"The 2-year occurrence of further decompensation was significantly lower in the CARVE group than in the PROPRA group (10.5% vs. 35.9%; P=0.003); survival at 2 years was significantly higher in the CARVE group (86% vs. 64.1%; P=0.01, respectively).
","['Patients With Cirrhosis and Ascites', 'decompensated cirrhosis with ascites', 'Ninety-six patients treated with', ""for esophageal varices' bleeding prophylaxis"", 'patients with cirrhosis and nonrefractory ascites', 'patients with stable cirrhosis and grade II/III nonrefractory ascites']","['Propranolol to Carvedilol', 'propranolol', 'propranolol to carvedilol', 'Carvedilol', 'continue propranolol', 'carvedilol', 'CARVE']","['systemic vascular resistance', 'serum noradrenaline', 'plasma renin activity', 'glomerular filtration rate', 'Systemic vascular resistance, vasoactive factors, glomerular filtration rate, and renal blood flow', 'renal blood flow', 'Renal Perfusion and Outcome', 'systemic hemodynamics and renal function', '2-year occurrence of further decompensation', 'decompensation and survival', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0014867', 'cui_str': 'Esophageal varices'}, {'cui': 'C1697249', 'cui_str': 'Haemorrhage prophylaxis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0054836', 'cui_str': 'carvedilol'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0035070', 'cui_str': 'Circulation, Renal'}, {'cui': 'C0194133', 'cui_str': 'Local perfusion of kidney'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",96.0,0.0369747,"The 2-year occurrence of further decompensation was significantly lower in the CARVE group than in the PROPRA group (10.5% vs. 35.9%; P=0.003); survival at 2 years was significantly higher in the CARVE group (86% vs. 64.1%; P=0.01, respectively).
","[{'ForeName': 'Georgios N', 'Initials': 'GN', 'LastName': 'Kalambokis', 'Affiliation': '1st Department of Internal Medicine.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Christaki', 'Affiliation': '1st Department of Internal Medicine.'}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Tsiakas', 'Affiliation': '1st Department of Internal Medicine.'}, {'ForeName': 'Grigorios', 'Initials': 'G', 'LastName': 'Despotis', 'Affiliation': '1st Department of Internal Medicine.'}, {'ForeName': 'Sempastien', 'Initials': 'S', 'LastName': 'Fillipas-Ntekouan', 'Affiliation': '1st Department of Internal Medicine.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fotopoulos', 'Affiliation': 'Laboratory of Nuclear Medicine.'}, {'ForeName': 'Spyridon', 'Initials': 'S', 'LastName': 'Tsiouris', 'Affiliation': 'Laboratory of Nuclear Medicine.'}, {'ForeName': 'Xanthi', 'Initials': 'X', 'LastName': 'Xourgia', 'Affiliation': 'Laboratory of Nuclear Medicine.'}, {'ForeName': 'Lampros', 'Initials': 'L', 'LastName': 'Lakkas', 'Affiliation': '2nd Department of Cardiology.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Pappas', 'Affiliation': '2nd Department of Cardiology.'}, {'ForeName': 'Lampros K', 'Initials': 'LK', 'LastName': 'Michalis', 'Affiliation': '2nd Department of Cardiology.'}, {'ForeName': 'Fotini', 'Initials': 'F', 'LastName': 'Sergianiti', 'Affiliation': 'Laboratory of Nuclear Medicine.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Baltayiannis', 'Affiliation': 'Department of Gastroenterology, School of Medicine, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Christodoulou', 'Affiliation': 'Department of Gastroenterology, School of Medicine, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Koustousi', 'Affiliation': '1st Department of Internal Medicine.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Aggelis', 'Affiliation': '1st Department of Internal Medicine.'}, {'ForeName': 'Haralampos', 'Initials': 'H', 'LastName': 'Milionis', 'Affiliation': '1st Department of Internal Medicine.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001431']
1897,32991946,The feasibility of a personality targeted intervention for addictive overeating: FoodFix.,"Recent reviews have identified potential treatment targets for addictive overeating. These include: motivational interviewing, development of specific coping strategies for emotional regulation and the use of harm minimisation strategies based on interventions for substance use disorders. However, there is very little experiential evidence. The aim of this study was to determine the feasibility of a personality-targeted motivational interviewing intervention in adults above the healthy-weight range with symptoms of addictive eating, to reduce symptoms of addictive overeating and improve dietary profiles. Individuals with overweight and obesity (BMI >25 kg/m 2 ) with addictive eating as defined by the modified Yale Food Addiction Scale (mYFAS) were recruited to a three-session intervention held over 3 months. Sessions were conducted by telehealth and facilitated by dietitians. Fifty-two individuals were randomised to either intervention or control (mean age 43.6 ± 12.2yrs, mean BMI 36.7 ± 6.8 kg/m 2 , 96% female). At three month follow up, there were significant reductions from baseline (BL) for both groups in total YFAS 2.0 symptoms, however, these changes were not significantly different between groups (intervention BL 8.0 ± 2.7; 3-months 6.5 ± 3.8, control BL 8.1 ± 2.5; 3-months 6.9 ± 3.9, p > 0.05). At 3 months the intervention group significantly reduced their energy from non-core foods compared with control (intervention BL 48% energy/day; 3-months 38%, control BL 41% energy/day; 3-months 38%, p < 0.01). The FoodFix intervention provides insight to the development of future management interventions for addictive eating.",2020,"At 3 months the intervention group significantly reduced their energy from non-core foods compared with control (intervention BL 48% energy/day; 3-months 38%, control BL 41% energy/day; 3-months 38%, p<0.01).","['Individuals with overweight and obesity (BMI >25kg/m 2 ) with addictive eating as defined by the modified Yale Food Addiction Scale (mYFAS', 'Fifty-two individuals were randomised to either intervention or control (mean age 43.6 ±12.2yrs, mean BMI 36.7±6.8kg/m 2 , 96% female', 'adults above the healthy-weight range with symptoms of addictive eating']","['personality-targeted motivational interviewing intervention', 'FoodFix intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],52.0,0.0215587,"At 3 months the intervention group significantly reduced their energy from non-core foods compared with control (intervention BL 48% energy/day; 3-months 38%, control BL 41% energy/day; 3-months 38%, p<0.01).","[{'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Burrows', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: Tracy.Burrows@newcastle.edu.au.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Collins', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: rebecca.collins10@newcastle.edu.au.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rollo', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: megan.rollo@newcastle.edu.au.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Leary', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: mark.leary@uon.edu.au.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hides', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, NSW, Australia. Electronic address: l.hides@uq.edu.au.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': 'School of Kinesiology and Health Sciences, York University, Toronto, Canada. Electronic address: cdavis@yorku.ca.'}]",Appetite,['10.1016/j.appet.2020.104974']
1898,32992020,Pain relief for osteoarthritis through combined treatment (PROACT): Protocol for a randomized controlled trial of mindfulness meditation combined with transcranial direct current stimulation in non-Hispanic black and white adults with knee osteoarthritis.,"Knee osteoarthritis (OA) is a leading cause of late life pain and disability, and non-Hispanic black (NHB) adults experience greater OA-related pain and disability than non-Hispanic whites (NHWs). Recent evidence implicates psychosocial stress, cognitive-attentional processes, and altered central pain processing as contributors to greater OA-related pain and disability among NHBs. To address these ethnic/race disparities, this clinical trial will test whether a mindfulness intervention (Breathing and Attention Training, BAT) combined with transcranial direct current stimulation (tDCS) will enhance pain modulatory balance and pain-related brain function, reduce clinical pain, and attenuate ethnic differences therein, among NHBs and NHWs with knee OA. Participants will complete assessments of clinical pain, function, psychosocial measures, and quantitative sensory testing (QST), including mechanical temporal summation and conditioned pain modulation. Neuroimaging will be performed to examine pain-related brain structure and function. Then, participants will be randomized to one of four groups created by crossing two BAT conditions (Real vs. Sham) with two tDCS conditions (Real vs. Sham). Participants will then undergo five treatment sessions during which the assigned BAT and tDCS interventions will be delivered concurrently for 20 min over one week. After the fifth intervention session, participants will undergo assessments of clinical pain and function, QST and neuroimaging identical to the pretreatment measures, and monthly follow-up assessments of pain will be conducted for three months. This will be the first study to determine whether mindfulness and tDCS treatments will show additive or synergistic effects when combined, and whether treatment effects differ across ethnic/race groups.",2020,"After the fifth intervention session, participants will undergo assessments of clinical pain and function, QST and neuroimaging identical to the pretreatment measures, and monthly follow-up assessments of pain will be conducted for three months.",['non-Hispanic black and white adults with knee osteoarthritis'],"['mindfulness intervention (Breathing and Attention Training, BAT) combined with transcranial direct current stimulation (tDCS', 'mindfulness meditation combined with transcranial direct current stimulation']","['Knee osteoarthritis (OA', 'Pain relief', 'clinical pain, function, psychosocial measures, and quantitative sensory testing (QST), including mechanical temporal summation and conditioned pain modulation']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0556509', 'cui_str': 'Attention training'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",,0.077445,"After the fifth intervention session, participants will undergo assessments of clinical pain and function, QST and neuroimaging identical to the pretreatment measures, and monthly follow-up assessments of pain will be conducted for three months.","[{'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Fillingim', 'Affiliation': 'Department of Community Dentistry & Behavioral Science, University of Florida, Gainesville, FL, USA; Pain Research & Intervention Center of Excellence, University of Florida, Gainesville, FL, USA. Electronic address: rfilling@ufl.edu.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Woods', 'Affiliation': 'Department of Clinical and Health Psychology, Center for Cognitive Aging and Memory, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Hyochol', 'Initials': 'H', 'LastName': 'Ahn', 'Affiliation': 'Department of Nursing Systems, University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Redden', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Lai', 'Affiliation': 'Department of Radiation Oncology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Deshpande', 'Affiliation': 'Department of Radiology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Deutsch', 'Affiliation': 'Department of Radiology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Kimberly T', 'Initials': 'KT', 'LastName': 'Sibille', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Staud', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Fadel', 'Initials': 'F', 'LastName': 'Zeidan', 'Affiliation': 'Department of Anesthesiology and Center for Mindfulness, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Burel R', 'Initials': 'BR', 'LastName': 'Goodin', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106159']
1899,32993464,Inter- and intra-core laboratory variability in the quantitative coronary angiography analysis for drug-eluting stent treatment and follow up.,"AIM


To evaluate inter-core laboratory variability of quantitative coronary angiography (QCA) parameters in comparison with intra-core laboratory variability in a randomized controlled trial evaluating drug-eluting stents.
METHODS


A total of 50 patients with 62 coronary lesions were analyzed by four analysis experts belonging to an Angiographic Core Laboratory (ACL: 1 expert) and a Cardiovascular Imaging Core Laboratory (CICL: 3 experts). QCA was based on the same standard operating procedure, but selections of projection and cine frames were at the discretion of each analyst. Inter- and intra-core laboratory variabilities were evaluated by accuracy, precision, Bland Altman analysis, and coefficient of variation.
RESULTS


Pre-MLD (minimal lumen diameter) was significantly smaller in results from ACL than those from all CICL experts. Number of analyzed projections did not affect pre-MLD results. Acute gain was larger in ACL than in CICL2. No significant difference was observed in late loss and loss index between inter-core laboratories. Agreement between core labs in the Bland-Altman analysis for each QCA parameter was as follows (mean difference, 95% limits of agreement): pre-MLD (-0.32, -0.74 to 0.10), stent MLD (0.08, -0.28 to 0.44), acute gain (0.22, -0.44 to 0.88), and late loss (-0.07, -0.69 to 0.55). Agreement between analysts in CICL (mean difference, 95% limits of agreement) was: pre MLD (-0.03, -0.37 to 0.31), stent MLD (0.15, -0.15 to 0.45), acute gain (0.05, -0.45 to 0.55), and late loss (0.04, -0.52 to 0.60). The widest limits of agreement among three analyses were shown in both analyses. Width of limited agreement in the intra-core laboratory analysis tended to be smaller than the inter-core laboratory analysis with these parameters. Coefficient of variation tended to be larger in lesion length (LL), acute gain, late loss, and loss index in inter- and in intra- core laboratory comparisons.
CONCLUSION


Inter-core laboratory QCA variability in late loss and loss index analysis could be similar to intra-core laboratory variability, but more strict alignment between core laboratories would be necessary for initial procedural data analysis.",2020,"Coefficient of variation tended to be larger in lesion length (LL), acute gain, late loss, and loss index in inter- and in intra- core laboratory comparisons.
",['50 patients with 62 coronary lesions were analyzed by four analysis experts belonging to an Angiographic Core Laboratory (ACL: 1 expert) and a Cardiovascular Imaging Core Laboratory (CICL: 3 experts'],"['QCA', 'quantitative coronary angiography (QCA']","['stent MLD', 'late loss', 'lesion length (LL), acute gain, late loss, and loss index', 'Inter- and intra-core laboratory variabilities', 'acute gain', 'late loss and loss index', 'Acute gain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0023522', 'cui_str': 'Metachromatic leukodystrophy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",50.0,0.156963,"Coefficient of variation tended to be larger in lesion length (LL), acute gain, late loss, and loss index in inter- and in intra- core laboratory comparisons.
","[{'ForeName': 'Shigenori', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Division of Cardiology, Sankuro Hospital, 7-80 Kosaka-cho, Toyota-shi, Aichi-ken, 471-0035, Japan.'}, {'ForeName': 'Kanako', 'Initials': 'K', 'LastName': 'Kinoshita', 'Affiliation': 'Japan Cardiovascular Imaging Core Laboratory, Tokyo, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Endo', 'Affiliation': 'Japan Cardiovascular Imaging Core Laboratory, Tokyo, Japan.'}, {'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Kami', 'Affiliation': 'Japan Cardiovascular Imaging Core Laboratory, Tokyo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Kotake', 'Affiliation': 'Japan Cardiovascular Imaging Core Laboratory, Tokyo, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Division of Cardiology, Toho University Medical Center Ohashi Hospital, Tokyo, Japan.'}]",Therapeutic advances in cardiovascular disease,['10.1177/1753944720958982']
1900,32993559,"Prospective, observational study to assess the performance of CAA measurement as a diagnostic tool for the detection of Schistosoma haematobium infections in pregnant women and their child in Lambaréné, Gabon: study protocol of the freeBILy clinical trial in Gabon.","BACKGROUND


Schistosoma antigen detection in urine is a valuable diagnostic approach for schistosomiasis control programmes because of the higher sensitivity compared to parasitological methods and preferred sampling of urine over stool. Highly accurate diagnostics are important in low Schistosoma transmission areas. Pregnant women and young children could particularly benefit from antigen testing as praziquantel (PZQ) can be given to only confirmed Schistosoma cases. This prevents the unborn baby from unnecessary exposure to PZQ. We present here the protocol of a diagnostic study that forms part of the freeBILy project. The aim is to evaluate the accuracy of circulating anodic antigen (CAA) detection for diagnosis of Schistosoma haematobium infections in pregnant women and to validate CAA as an endpoint measure for anti-Schistosoma drug efficacy. The study will also investigate Schistosoma infections in infants.
METHODS


A set of three interlinked prospective, observational studies is conducted in Gabon. The upconverting phosphor lateral flow (UCP-LF) CAA test is the index diagnostic test that will be evaluated. The core trial, sub-study A, comprehensively evaluates the accuracy of the UCP-LF CAA urine test against a set of other Schistosoma diagnostics in a cross-sectional trial design. Women positive for S. haematobium will proceed with sub-study B and will be randomised to receive PZQ treatment immediately or after delivery followed by weekly sample collection. This approach includes comparative monitoring of CAA levels following PZQ intake and will also contribute further data for safety of PZQ administration during pregnancy. Sub-study C is a longitudinal study to determine the incidence of S. haematobium infection as well as the age for first infection in life-time.
DISCUSSION


The freeBILy trial in Gabon will generate a comprehensive set of data on the accuracy of the UCP-LF CAA test for the detection of S. haematobium infection in pregnant women and newborn babies and for the use of CAA as a marker to determine PZQ efficacy. Furthermore, incidence of Schistosoma infection in infants will be reported. Using the ultrasensitive diagnostics, this information will be highly relevant for Schistosoma prevalence monitoring by national control programs as well as for the development of medicaments and vaccines.
TRIAL REGISTRATION


The registration number of this study is NCT03779347 ( clinicaltrials.gov , date of registration: 19 December 2018).",2020,"BACKGROUND


Schistosoma antigen detection in urine is a valuable diagnostic approach for schistosomiasis control programmes because of the higher sensitivity compared to parasitological methods and preferred sampling of urine over stool.","['Pregnant women and young children', 'pregnant women', 'pregnant women and newborn babies', 'pregnant women and their child in Lambaréné, Gabon: study protocol of the freeBILy clinical trial in Gabon', 'Schistosoma infections in infants']","['CAA measurement', 'UCP-LF CAA test', 'praziquantel (PZQ', 'PZQ', 'circulating anodic antigen (CAA) detection']",['Schistosoma infection'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0016910', 'cui_str': 'Gabon'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036315', 'cui_str': 'Schistosoma'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0430420', 'cui_str': 'Antigen assay'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0729856', 'cui_str': 'Antigen test'}, {'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]","[{'cui': 'C0036315', 'cui_str': 'Schistosoma'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.0991113,"BACKGROUND


Schistosoma antigen detection in urine is a valuable diagnostic approach for schistosomiasis control programmes because of the higher sensitivity compared to parasitological methods and preferred sampling of urine over stool.","[{'ForeName': 'Yabo Josiane', 'Initials': 'YJ', 'LastName': 'Honkpehedji', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.'}, {'ForeName': 'Ayôla Akim', 'Initials': 'AA', 'LastName': 'Adegnika', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.'}, {'ForeName': 'Jean Claude', 'Initials': 'JC', 'LastName': 'Dejon-Agobe', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.'}, {'ForeName': 'Jeannot Fréjus', 'Initials': 'JF', 'LastName': 'Zinsou', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.'}, {'ForeName': 'Romuald Beh', 'Initials': 'RB', 'LastName': 'Mba', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Gerstenberg', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.'}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Rakotozandrindrainy', 'Affiliation': ""Université d'Antananarivo, Antananarivo, Madagascar.""}, {'ForeName': 'Rivo Andry', 'Initials': 'RA', 'LastName': 'Rakotoarivelo', 'Affiliation': 'Université de Fianarantsoa, Fianarantsoa, Madagascar.'}, {'ForeName': 'Tahinamandranto', 'Initials': 'T', 'LastName': 'Rasamoelina', 'Affiliation': ""Centre d'Infectiologie Charles Mérieux, Antananarivo, Madagascar.""}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Sicuri', 'Affiliation': 'Fundación Privada Instituto de Salud Global Barcelona, Barcelona, Spain.'}, {'ForeName': 'Norbert G', 'Initials': 'NG', 'LastName': 'Schwarz', 'Affiliation': 'Bernhard-Nocht-Institut für Tropenmedizin, Hamburg, Germany.'}, {'ForeName': 'Paul L A M', 'Initials': 'PLAM', 'LastName': 'Corstjens', 'Affiliation': 'Department of Cell and Chemical Biology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Pytsje T', 'Initials': 'PT', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Govert J', 'Initials': 'GJ', 'LastName': 'van Dam', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kreidenweiss', 'Affiliation': 'Institut für Tropenmedizin, Universität Tübingen, Tübingen, Germany. andrea.kreidenweiss@uni-tuebingen.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC infectious diseases,['10.1186/s12879-020-05445-1']
1901,32994178,Electromagnetic Versus Blind Guidance of a Postpyloric Feeding Tube in Critically Ill Children.,"BACKGROUND AND OBJECTIVES


Postpyloric feeding tube placement is a time-consuming procedure associated with multiple attempts and radiation exposure. Our objective with this study is to compare the time, attempts, and radiation exposure using the electromagnetic versus blind method to place a postpyloric feeding tube in critically ill children. Our hypothesis is that using electromagnetic guidance decreases the procedure time, number of x-rays, and number of attempts, compared to the blind method.
METHODS


Eleven pediatric nurses participated in a randomized controlled intention-to-treat study at an academic pediatric medical, surgical, and congenital cardiac ICU. University of Texas Health Epidemiology and Biostatistics generated a randomization sequence with sealed envelopes. A standard (2-sided) F-test of association between the electromagnetic and blind method yielded 40 subjects with 86% power. Data were analyzed with Fisher's exact test for categorical variables and the Wilcoxon rank test for continuous variables, with data documented as median (interquartile range [IQR]).
RESULTS


We randomly assigned 52 patients to either the electromagnetic ( n  = 28) or blind method ( n  = 24). The number of attempts and radiographs was at a median of 2 (IQR: 1-2.25) using the blind method, compared to the electromagnetic method at a median of 1 (IQR: 1.0-1.0;  P  = .001). Successful guidance was 96.4% with the electromagnetic method, compared to only 66.7% with the blind technique ( P  = .008). The total time required was 2.5 minutes (IQR: 2.0-7.25) with the electromagnetic method, compared to 19 minutes (IQR: 9.25-27.0) for the blind method ( P  = .001).
CONCLUSIONS


Electromagnetic guidance is a superior, faster, and overall safer method to place a postpyloric feeding tube in critically ill children.",2020,"Successful guidance was 96.4% with the electromagnetic method, compared to only 66.7% with the blind technique ( P  = .008).","['critically ill children', 'Eleven pediatric nurses participated in a randomized controlled intention-to-treat study at an academic pediatric medical, surgical, and congenital cardiac ICU', 'Critically Ill Children', '40 subjects with 86% power']","['Electromagnetic Versus Blind Guidance of a Postpyloric Feeding Tube', 'Electromagnetic guidance', 'electromagnetic']","['number of attempts and radiographs', 'procedure time, number of x-rays, and number of attempts', 'total time required']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030753', 'cui_str': 'Nursing, Pediatric'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C2945625', 'cui_str': 'Feeding tube'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",52.0,0.0772211,"Successful guidance was 96.4% with the electromagnetic method, compared to only 66.7% with the blind technique ( P  = .008).","[{'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Jha', 'Affiliation': ""Division of Critical Care, Department of Pediatrics, Children's Hospital of Nevada at University Medical Center, Las Vegas, Nevada; prashant.jha@umcsn.com.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Rupp', 'Affiliation': 'Pediatric Services, University Health System, San Antonio, Texas; and.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Bonilla', 'Affiliation': 'Pediatric Services, University Health System, San Antonio, Texas; and.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Gelfond', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of Texas Health San Antonio, San Antonio, Texas.'}, {'ForeName': 'Jay N', 'Initials': 'JN', 'LastName': 'Shah', 'Affiliation': 'Pediatric Services, University Health System, San Antonio, Texas; and.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Meyer', 'Affiliation': 'Pediatric Services, University Health System, San Antonio, Texas; and.'}]",Pediatrics,['10.1542/peds.2019-3773']
1902,33004143,"Laparoscopic hiatal hernia repair as same day surgery: Feasibility, short-term outcomes and costs.","INTRODUCTION


Laparoscopic hiatal hernia repair is commonly performed with 1 night hospitalization. The aim was to assess repairs as same-day-surgery (SDS).
METHODS


Costs/short-term outcomes of SDS were compared to hospital-stay < 24-h: observation (OBS) and hospital-stay ≥ 24-h: inpatient (INP). Outcomes were assessed by postoperative 30-day ER visits/readmissions.
RESULTS


There were 262 procedures, excluding 50 reoperative repairs, 212 procedures were included: There were 66 SDS, 65 OBS and 81 INP. SDS vs. OBS: OBS were older, had higher ASA, less type I and more type III and IV hernias. Costs were significantly less in the SDS group with no difference in post-operative ER visits/post-discharge readmissions. SDS vs. INP: INP were older, had higher ASA, less type I and more type III and IV hernias. Costs were significantly less in the SDS group with no difference in post-operative ER visits/post-discharge readmissions.
CONCLUSION


Laparoscopic hiatal hernia repair can be performed as SDS in majority of elective repairs with good short-term outcomes and reduced cost.",2020,"Costs were significantly less in the SDS group with no difference in post-operative ER visits/post-discharge readmissions.
","['There were 262 procedures, excluding 50 reoperative repairs, 212 procedures were included: There were 66 SDS, 65 OBS and 81 INP']","['Laparoscopic hiatal hernia repair', 'SDS vs. OBS']","['hospital-stay\xa0<\xa024-h: observation (OBS) and hospital-stay\xa0≥', 'postoperative 30-day ER visits/readmissions', 'Costs']","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282046', 'cui_str': 'Day Surgery'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0014857', 'cui_str': 'Repair of paraesophageal diaphragmatic hernia'}, {'cui': 'C0282046', 'cui_str': 'Day Surgery'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0733415,"Costs were significantly less in the SDS group with no difference in post-operative ER visits/post-discharge readmissions.
","[{'ForeName': 'Rigoberto', 'Initials': 'R', 'LastName': 'Gutierrez', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston (UTHealth), United States.'}, {'ForeName': ""Colleen O'"", 'Initials': 'CO', 'LastName': 'Neill', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston (UTHealth), United States.'}, {'ForeName': 'Anshu', 'Initials': 'A', 'LastName': 'Khanna', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston (UTHealth), United States.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Miller', 'Affiliation': 'Memorial Hermann Southeast Esophageal Disease Center, United States.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Banki', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston (UTHealth), United States; Memorial Hermann Southeast Esophageal Disease Center, United States. Electronic address: farzaneh.banki@uth.tmc.edu.'}]",American journal of surgery,['10.1016/j.amjsurg.2020.09.009']
1903,33007710,Working out the worries: A randomized controlled trial of high intensity interval training in generalized anxiety disorder.,"BACKGROUND


Aerobic exercise (AE) demonstrated an overall medium treatment effect in anxiety disorders (AD) but there is evidence for an ""intensity-response"" relationship. High intensity interval training (HIIT) was highly effective on a range of (mental) health parameters. However, so far no randomised-controlled trial (RCT) investigated the efficacy of HIIT in AD.
METHODS


33 patients with generalized anxiety disorder (GAD) were randomly assigned to 12-day HIIT or a training of lower intensity (LIT). Anxiety, comorbid depression, stress-related bodily symptoms and perceived control over anxiety related stimuli (PC) were assessed at baseline, post-training and 30 days after baseline by using the Penn State Worry Questionnaire (PSWQ), the Hamilton Inventories for Anxiety and Depression (Ham-A, Ham-D), the Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R).
RESULTS


Both interventions showed moderate or large effects on all clinical measures. However, effects for HIIT were generally about twice as high as for LIT. PC negatively correlated with GAD severity in the whole sample at baseline but an association of training-induced changes in PC and worrying were exclusively detectable in HIIT.
CONCLUSION


HIIT was highly effective and fast acting in GAD. Therefore, it may complement first-line treatment approaches in this condition.",2020,", the Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R).
","['generalized anxiety disorder', '33 patients with generalized anxiety disorder (GAD']","['Aerobic exercise (AE', 'High intensity interval training (HIIT', 'high intensity interval training', '12-day HIIT or a training of lower intensity (LIT']","['Anxiety, comorbid depression, stress-related bodily symptoms and perceived control over anxiety related stimuli (PC', 'Penn State Worry Questionnaire (PSWQ), the Hamilton Inventories for Anxiety and Depression', 'GAD severity', 'Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C2959752', 'cui_str': 'Penn State worry questionnaire'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",33.0,0.0824276,", the Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R).
","[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Plag', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: jens.plag@charite.de.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Schmidt-Hellinger', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Sports Medicine, Berlin, Germany. Electronic address: paul-juergen.schmidt@charite.de.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Klippstein', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: theresa.klippstein@charite.de.'}, {'ForeName': 'Jennifer L M', 'Initials': 'JLM', 'LastName': 'Mumm', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: jennifer.mumm@charite.de.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wolfarth', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Sports Medicine, Berlin, Germany. Electronic address: bernd.wolfarth@charite.de.'}, {'ForeName': 'Moritz B', 'Initials': 'MB', 'LastName': 'Petzold', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: moritz.petzold@charite.de.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: andreas.stroehle@charite.de.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102311']
1904,32988690,A randomized controlled trial of an online immunization curriculum.,"INTRODUCTION


Immunization education for physicians-in-training is crucial to address vaccine concerns in clinical practice. Vaccine education is not standardized across residency programs. The Collaboration for Vaccination Education and Research (CoVER) team developed an online curriculum for pediatric (Peds) and family medicine (FM) residents.
METHODS


A cluster randomized controlled trial (RCT) was performed during the 2017-2018 academic year to evaluate the CoVER curriculum. A convenience sample of residency institutions were randomly allocated to the intervention or control group, with stratification by residency type. The intervention, the CoVER curriculum, consisted of four online modules and an in-person training guide. Control sites continued with their standard vaccine education. Pre-intervention and post-intervention surveys were emailed to residents in both groups. The primary outcomes compared between groups were changes in ""vaccine knowledge,"" ""vaccine attitudes/hesitancy,"" and ""self-confidence"" in immunization communication. The team assessing outcomes was unblinded to assignments. Hierarchical general linear model was used to adjust for residency type and residency year; residency site was modeled as a random effect.
RESULTS


Overall, 1444 residents from 31 residency programs were eligible to participate (734 intervention, 710 control). The pre-intervention response rate was 730 (51%) and post-intervention was 526 (36%). Average knowledge scores increased from pre-intervention (control 53%; CoVER 53%) to post-intervention (control 58%; CoVER 60%). Increases in vaccine knowledge among FM residents were greater for CoVER compared to controls (p = 0.041). Vaccine hesitancy was more common among FM (23%) than Peds (10%) residents. In all three residency years, residents in the CoVER group showed greater increases in self-confidence in ability to discuss vaccines with parents/patients (p < 0.03) compared to control group.
CONCLUSION


The CoVER curriculum is an effective model to standardize immunization education of physicians-in-training. This RCT demonstrated the effectiveness of the CoVER curriculum to improve resident confidence in their ability to discuss vaccines with parents and patients.",2020,"In all three residency years, residents in the CoVER group showed greater increases in self-confidence in ability to discuss vaccines with parents/patients (p < 0.03) compared to control group.
","['A convenience sample of residency institutions', '1444 residents from 31 residency programs were eligible to participate (734 intervention, 710 control', '2017-2018 academic year to evaluate the CoVER curriculum']",['online immunization curriculum'],"['vaccine knowledge,"" ""vaccine attitudes/hesitancy,"" and ""self-confidence"" in immunization communication', 'Vaccine hesitancy', 'vaccine knowledge', 'self-confidence', 'pre-intervention response rate', 'Average knowledge scores']","[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0152032', 'cui_str': 'Delay when starting to pass urine'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0637888,"In all three residency years, residents in the CoVER group showed greater increases in self-confidence in ability to discuss vaccines with parents/patients (p < 0.03) compared to control group.
","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pahud', 'Affiliation': ""Children's Mercy Hospital, Department of Pediatrics, UMKC School of Medicine, 2401 Gillham Road, Kansas City, MO 64108, United States. Electronic address: bapahud@cmh.edu.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Elizabeth Williams', 'Affiliation': ""Vanderbilt Department of Pediatrics, Division of General Pediatrics, 2200 Children's Way, 8232 Doctors' Office Tower, Nashville, TN 37232, United States. Electronic address: elizabeth.williams@vumc.org.""}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Lee', 'Affiliation': ""Children's Mercy Hospital, Department of Pediatrics, UMKC School of Medicine, 2401 Gillham Road, Kansas City, MO 64108, United States. Electronic address: blee@cmh.edu.""}, {'ForeName': 'Kadriye O', 'Initials': 'KO', 'LastName': 'Lewis', 'Affiliation': ""Children's Mercy Hospital, Department of Pediatrics, UMKC School of Medicine, 2401 Gillham Road, Kansas City, MO 64108, United States. Electronic address: kolewis@cmh.edu.""}, {'ForeName': 'Donald B', 'Initials': 'DB', 'LastName': 'Middleton', 'Affiliation': 'University of Pittsburgh Medical Center, 815 Freeport Road, Pittsburgh, PA 15215, United States. Electronic address: middletondb@upmc.edu.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': ""Children's Mercy Hospital, Department of Pediatrics, UMKC School of Medicine, 2401 Gillham Road, Kansas City, MO 64108, United States. Electronic address: sclark2@cmh.edu.""}, {'ForeName': 'Sharon G', 'Initials': 'SG', 'LastName': 'Humiston', 'Affiliation': ""Children's Mercy Hospital, Department of Pediatrics, UMKC School of Medicine, 2401 Gillham Road, Kansas City, MO 64108, United States. Electronic address: sghumiston@cmh.edu.""}]",Vaccine,['10.1016/j.vaccine.2020.09.043']
1905,32989082,Delivery and Impact of a Motivational Intervention for Smoking Cessation: A PROS Study.,"OBJECTIVES


We tested a Public Health Service 5As-based clinician-delivered smoking cessation counseling intervention with adolescent smokers in pediatric primary care practice.
METHODS


We enrolled clinicians from 120 practices and recruited youth (age ≥14) from the American Academy of Pediatrics Pediatric Research in Office Settings practice-based research network. Practices were randomly assigned to training in smoking cessation (intervention) or social media counseling (attentional control). Youth recruited during clinical visits completed confidential screening forms. All self-reported smokers and a random sample of nonsmokers were offered enrollment and interviewed by phone at 4 to 6 weeks, 6 months, and 12 months after visits. Measures included adolescents' report of clinicians' delivery of screening and counseling, current tobacco use, and cessation behaviors and intentions. Analysis assessed receipt of screening and counseling, predictors of receiving 5As counseling, and effects of interventions on smoking behaviors and cessation at 6 and 12 months.
RESULTS


Clinicians trained in the 5As intervention delivered more screening (β = 1.0605,  P  < .0001) and counseling (β = 0.4354,  P  < .0001). In both arms, clinicians more often screened smokers than nonsmokers. At 6 months, study arm was not significantly associated with successful cessation; however, smokers in the 5As group were more likely to have quit at 12 months. Addicted smokers more often were counseled, regardless of study arm, but were less likely to successfully quit smoking.
CONCLUSIONS


Adolescent smokers whose clinicians were trained in 5As were more likely to receive smoking screening and counseling than controls, but the ability of this intervention to help adolescents quit smoking was limited.",2020,"RESULTS


Clinicians trained in the 5As intervention delivered more screening (β = 1.0605,  P  < .0001) and counseling (β = 0.4354,  P  < .0001).","['120 practices and recruited youth (age ≥14) from the American Academy of Pediatrics Pediatric Research in Office Settings practice-based research network', 'Adolescent smokers', 'adolescent smokers in pediatric primary care practice', 'Smoking Cessation', 'Youth recruited during clinical visits completed confidential screening forms']","['Motivational Intervention', 'smoking screening and counseling', 'Public Health Service 5As-based clinician-delivered smoking cessation counseling intervention', 'training in smoking cessation (intervention) or social media counseling (attentional control']","['successful cessation', ""adolescents' report of clinicians' delivery of screening and counseling, current tobacco use, and cessation behaviors and intentions""]","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0041734', 'cui_str': 'United States. Public Health Service'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0315772,"RESULTS


Clinicians trained in the 5As intervention delivered more screening (β = 1.0605,  P  < .0001) and counseling (β = 0.4354,  P  < .0001).","[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Klein', 'Affiliation': 'Department of Pediatrics, University of Illinois at Chicago, Chicago, Illinois; jonklein@uic.edu.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Gorzkowski', 'Affiliation': 'Julius B. Richmond Center of Excellence, American Academy of Pediatrics, Itasca, Illinois.'}, {'ForeName': 'Elissa A', 'Initials': 'EA', 'LastName': 'Resnick', 'Affiliation': 'Department of Pediatrics, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Harris', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Kaseeska', 'Affiliation': 'Julius B. Richmond Center of Excellence, American Academy of Pediatrics, Itasca, Illinois.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Pbert', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, Massachusetts.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Prokorov', 'Affiliation': 'MD Anderson Center, Houston, Texas.'}, {'ForeName': 'Tianxiu', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Gotlieb', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Wasserman', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois.'}]",Pediatrics,['10.1542/peds.2020-0644']
1906,32991399,Effectiveness and safety of light vegetarian diet and Qingjiang Tiaochang Recipe for functional constipation: An exploratory study protocol for randomized controlled trial.,"INTRODUCTION


Functional constipation is a chronic disease that is common in children and adults around the world. The treatments for functional constipation include diet and lifestyle interventions, medications, and surgery. The diet pattern plays an important role in the occurrence of constipation. We found in clinical practice that simple application of drugs cannot achieve long-term relief of constipation, and a large number of patients are not satisfied with the existing treatment. We have concluded that Qingjiang Tiaochang Recipe (QJTCR) and light vegetarian diet (LVD) can effectively improve constipation. However, there is no enough evidence for the description of the effect. This protocol aims at exploratorily investigating effectiveness and safety of LVD and QJTCR following a rigorous clinical trial.
METHODS AND ANALYSIS


We will recruit 90 patients to participate in this prospective, placebo-controlled, randomized trial, and exploratory study at the China-Japan Friendship Hospital, including traditional Chinese medicine group, placebo + diet group, traditional Chinese medicine + diet group. Patients in the diet intervention group must strictly abide by LVD, and the study will continue for 28 days. During the intervention period, we need to record a designed diary to assess diet quality and defecation. The primary outcomes for this clinical study were weekly complete spontaneous bowel movements. The secondary outcomes were constipation-related symptom rating scale, traditional Chinese medicine syndrome scale, and 48-hour gastrointestinal transit time, high-resolution anorectal manometry, Bristol stool score, constipation quality of life assessment scale, constipation symptoms self-assessment scale, short-chain fatty acids in feces. In addition, the study will determine the safety of the intervention.",2020,"The secondary outcomes were constipation-related symptom rating scale, traditional Chinese medicine syndrome scale, and 48-hour gastrointestinal transit time, high-resolution anorectal manometry, Bristol stool score, constipation quality of life assessment scale, constipation symptoms self-assessment scale, short-chain fatty acids in feces.","['90 patients to participate in this prospective, placebo-controlled, randomized trial, and exploratory study at the China-Japan Friendship Hospital, including traditional Chinese medicine group', 'functional constipation']","['LVD and QJTCR', 'diet intervention', 'Qingjiang Tiaochang Recipe (QJTCR) and light vegetarian diet (LVD', 'placebo + diet group, traditional Chinese medicine + diet group', 'light vegetarian diet and Qingjiang Tiaochang Recipe']","['weekly complete spontaneous bowel movements', 'constipation-related symptom rating scale, traditional Chinese medicine syndrome scale, and 48-hour gastrointestinal transit time, high-resolution anorectal manometry, Bristol stool score, constipation quality of life assessment scale, constipation symptoms self-assessment scale, short-chain fatty acids in feces', 'constipation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0311164', 'cui_str': 'Vegetarian diet'}, {'cui': 'C0600194', 'cui_str': 'Recipes'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0429688', 'cui_str': 'Symptom ratings'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0232484', 'cui_str': 'Gastrointestinal transit time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0374190', 'cui_str': 'Anorectal manometry'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}]",90.0,0.0717254,"The secondary outcomes were constipation-related symptom rating scale, traditional Chinese medicine syndrome scale, and 48-hour gastrointestinal transit time, high-resolution anorectal manometry, Bristol stool score, constipation quality of life assessment scale, constipation symptoms self-assessment scale, short-chain fatty acids in feces.","[{'ForeName': 'Xinyuan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'School of Graduates, Beijing University of Chinese Medicine.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Graduates, Beijing University of Chinese Medicine.'}, {'ForeName': 'Jialiang', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Graduates, Beijing University of Chinese Medicine.'}, {'ForeName': 'Huijing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'School of Graduates, Beijing University of Chinese Medicine.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Peking University China-Japan Friendship School of Clinical Medicine, Peking University.'}, {'ForeName': 'Zuohu', 'Initials': 'Z', 'LastName': 'Niu', 'Affiliation': 'School of Graduates, Beijing University of Chinese Medicine.'}, {'ForeName': 'Zhangjun', 'Initials': 'Z', 'LastName': 'Yun', 'Affiliation': 'School of Graduates, Beijing University of Chinese Medicine.'}, {'ForeName': 'Bingzhi', 'Initials': 'B', 'LastName': 'Ma', 'Affiliation': 'Department of Pharmacy, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Shunkun', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Department of Gastroenterology of Traditional Chinese Medicine, China-Japan Friendship Hospital.'}]",Medicine,['10.1097/MD.0000000000021363']
1907,32991411,"Evaluation of the impact of Tacrolimus-based immunosuppression on Heidelberg liver transplant cohort (HDTACRO): Study protocol for an investigator initiated, non-interventional prospective study.","BACKGROUND


Tacrolimus-based immunosuppression has resulted in enormous improvements on liver transplantation (LTx) outcomes. However, dose adjustment and medication adherence play a key role in post-transplant treatment success. The aim of the present study is to assess the trough levels and the need for adaptation of therapeutic doses in de novo LTx patients treated with Tacrolimus in the clinical routine, without any intervention to the treatment regimen.
METHODS AND ANALYSIS


This is a pilot, prospective, exploratory, monocentric, non-interventional and non-randomized investigator-initiated study. Prospectively maintained data of 100 patients treated with various oral Tacrolimus-based immunosuppressants (Prograf or Envarsus) will be analyzed. The number of required dose adjustments of Tacrolimus formulations used in clinical routine for achieving the target trough level, Tacrolimus trough level, Tacrolimus dosing, concentration/dose ratio, routine laboratory tests, efficacy data (incl. survival, acute rejection, re-transplantation), patients therapy adherence, and infections requiring the need to reduce individual immunosuppressant dosing will be evaluated for each patient.
RESULT


This study will evaluate the trough levels and the need for adaptation of therapeutic doses in de novo LTx patients treated with Tacrolimus in the clinical routine, without any intervention to the treatment regimen.
CONCLUSION


The HDTACRO study will be the first study to systematically and prospectively evaluate various oral Tacrolimus-based immunosuppressants in de novo liver transplanted patients. If a difference between the therapy-subgroups is evident at the end of the trial, a randomized control trial will eventually be designed. Registration number: ClinicalTrials.gov: NCT04444817.",2020,"If a difference between the therapy-subgroups is evident at the end of the trial, a randomized control trial will eventually be designed.","['Heidelberg liver transplant cohort (HDTACRO', 'de novo LTx patients treated with', '100 patients treated with', 'in de novo liver transplanted patients']","['Tacrolimus-based immunosuppressants', 'various oral Tacrolimus-based immunosuppressants (Prograf or Envarsus', 'Tacrolimus-based immunosuppression', 'Tacrolimus']","['target trough level, Tacrolimus trough level, Tacrolimus dosing, concentration/dose ratio, routine laboratory tests, efficacy data', 'survival, acute rejection, re-transplantation']","[{'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0678125', 'cui_str': 'Prograft'}, {'cui': 'C4050793', 'cui_str': 'Envarsus'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]",100.0,0.0415723,"If a difference between the therapy-subgroups is evident at the end of the trial, a randomized control trial will eventually be designed.","[{'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Khajeh', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Polychronidis', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ramouz', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Parnian', 'Initials': 'P', 'LastName': 'Alamdari', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Lemekhova', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Melisa', 'Initials': 'M', 'LastName': 'Saracevic', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Sadeq', 'Initials': 'S', 'LastName': 'Ali-Hasan-Al-Saegh', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Ghamarnejad', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Majlesara', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Abbasi Dezfouli', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Nickkholgh', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Karl Heinz', 'Initials': 'KH', 'LastName': 'Weiss', 'Affiliation': 'Department of Gastroenterology and Hepatology, University of Heidelberg.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rupp', 'Affiliation': 'Department of Internal Medicine, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Arianeb', 'Initials': 'A', 'LastName': 'Mehrabi', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Mieth', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}]",Medicine,['10.1097/MD.0000000000022180']
1908,32992075,Intermediate versus standard-dose prophylactic anticoagulation and statin therapy versus placebo in critically-ill patients with COVID-19: Rationale and design of the INSPIRATION/INSPIRATION-S studies.,"BACKGROUND


Microvascular and macrovascular thrombotic events are among the hallmarks of coronavirus disease 2019 (COVID-19). Furthermore, the exuberant immune response is considered an important driver of pulmonary and extrapulmonary manifestations of COVID-19. The optimal management strategy to prevent thrombosis in critically-ill patients with COVID-19 remains unknown.
METHODS


The Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) and INSPIRATION-statin (INSPIRATION-S) studies test two independent hypotheses within a randomized controlled trial with 2 × 2 factorial design. Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation. The 600 patients undergoing this randomization will be screened and if meeting the eligibility criteria, will undergo an additional double-blind stratified randomization to atorvastatin 20 mg daily versus matching placebo. The primary endpoint, for both hypotheses will be tested for superiority and includes a composite of adjudicated acute arterial thrombosis, venous thromboembolism (VTE), use of extracorporeal membrane oxygenation, or all-cause death within 30 days from enrollment. Key secondary endpoints include all-cause mortality, adjudicated VTE, and ventilator-free days. Key safety endpoints include major bleeding according to the Bleeding Academic Research Consortium definition and severe thrombocytopenia (platelet count <20,000/fL) for the anticoagulation hypothesis. In a prespecified secondary analysis for non-inferiority, the study will test for the non-inferiority of intermediate intensity versus standard dose anticoagulation for major bleeding, considering a non-inferiority margin of 1.8 based on odds ratio. Key safety endpoints for the statin hypothesis include rise in liver enzymes >3 times upper normal limit and clinically-diagnosed myopathy. The primary analyses will be performed in the modified intention-to-treat population. Results will be tested in exploratory analyses across key subgroups and in the intention-to-treat and per-protocol cohorts.
CONCLUSIONS


INSPIRATION and INSPIRATON-S studies will help address clinically-relevant questions for antithrombotic therapy and thromboinflammatory therapy in critically-ill patients with COVID-19.",2020,Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation.,"['critically-ill patients with COVID-19 remains unknown', '600 patients undergoing this randomization will be screened and if meeting the eligibility criteria', 'cRitically-ill pATIents with COVID-19', 'critically-ill patients with COVID-19', 'Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19']","['Intermediate versus standard-dose prophylactic anticoagulation and statin therapy versus placebo', 'Prophylactic anticoagulation', 'atorvastatin 20\xa0mg daily versus matching placebo']","['major bleeding according to the Bleeding Academic Research Consortium definition and severe thrombocytopenia (platelet count <20,000/fL', 'composite of adjudicated acute arterial thrombosis, venous thromboembolism (VTE), use of extracorporeal membrane oxygenation, or all-cause death', 'cause mortality, adjudicated VTE, and ventilator-free days']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1379773', 'cui_str': 'atorvastatin 20 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0151942', 'cui_str': 'Arterial thrombosis'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",600.0,0.474016,Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation.,"[{'ForeName': 'Behnood', 'Initials': 'B', 'LastName': 'Bikdeli', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Yale/YNHH Center for Outcomes Research & Evaluation, New Haven, CT, USA; Cardiovascular Research Foundation (CRF), New York, NY, USA. Electronic address: bbikdeli@bwh.harvard.edu.""}, {'ForeName': 'Azita H', 'Initials': 'AH', 'LastName': 'Talasaz', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Rashidi', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Sharif-Kashani', 'Affiliation': 'Tobacoo Prevention and control Research center, National Research lnstitute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran; Lung Transplantion Research Center, Department of Cardiology, National Research Institute of Tuberculosls and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Farrokhpour', 'Affiliation': 'Firouzgar Hospital, Department of Internal Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Bakhshandeh', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Hashem', 'Initials': 'H', 'LastName': 'Sezavar', 'Affiliation': 'Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dabbagh', 'Affiliation': 'Department of Anesthesiology, School of Medicine Anesthesiology Research Center Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Beigmohammadi', 'Affiliation': 'Anesthesiology and Intensive Care, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Payandemehr', 'Affiliation': 'Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Yadollahzadeh', 'Affiliation': 'Firouzgar Hospital, Department of Internal Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Taghi', 'Initials': 'T', 'LastName': 'Riahi', 'Affiliation': 'Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Jamalkhani', 'Affiliation': 'Student Research Committee, Iran University of Medical Sciences, Tehran, Iran; Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Rezaeifar', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Abedini', 'Affiliation': 'Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Lookzadeh', 'Affiliation': 'Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shaghayegh', 'Initials': 'S', 'LastName': 'Shahmirzaei', 'Affiliation': 'Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ouria', 'Initials': 'O', 'LastName': 'Tahamtan', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Matin', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Ehsan', 'Initials': 'SE', 'LastName': 'Parhizgar', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jimenez', 'Affiliation': 'Respiratory Department, Hospital Ramón y Cajal (IRYCIS), Madrid, Spain; Medicine Department, Universidad de Alcalá (IRYCIS), Madrid, Spain; CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Aakriti', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Mahesh V', 'Initials': 'MV', 'LastName': 'Madhavan', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Sahil A', 'Initials': 'SA', 'LastName': 'Parikh', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Monreal', 'Affiliation': 'Department of Internal Medicine, Hospital Germans Trias i Pujol, Badalona, Barcelona, Universidad Católica de Murcia, Murcia, Spain.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Hadavand', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Hajighasemi', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Maleki', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Sadeghian', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Mohebbi', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Piazza', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Harlan M', 'Initials': 'HM', 'LastName': 'Krumholz', 'Affiliation': 'Yale/YNHH Center for Outcomes Research & Evaluation, New Haven, CT, USA; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA; Department of Health Policy and Adminitration, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Parham', 'Initials': 'P', 'LastName': 'Sadeghipour', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Iran; Clinical Trial Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Iran. Electronic address: psadeghipour@hotmail.com.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.027']
1909,32992107,Disseminating trial results: We can have both faster and better.,,2020,,[],[],[],[],[],[],,0.0376918,,"[{'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Simon', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA. Electronic address: Gregory.E.Simon@kp.org.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Richesson', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}]","Healthcare (Amsterdam, Netherlands)",['10.1016/j.hjdsi.2020.100474']
1910,32992136,Improving the performance of CNN to predict the likelihood of COVID-19 using chest X-ray images with preprocessing algorithms.,"OBJECTIVE


This study aims to develop and test a new computer-aided diagnosis (CAD) scheme of chest X-ray images to detect coronavirus (COVID-19) infected pneumonia.
METHOD


CAD scheme first applies two image preprocessing steps to remove the majority of diaphragm regions, process the original image using a histogram equalization algorithm, and a bilateral low-pass filter. Then, the original image and two filtered images are used to form a pseudo color image. This image is fed into three input channels of a transfer learning-based convolutional neural network (CNN) model to classify chest X-ray images into 3 classes of COVID-19 infected pneumonia, other community-acquired no-COVID-19 infected pneumonia, and normal (non-pneumonia) cases. To build and test the CNN model, a publicly available dataset involving 8474 chest X-ray images is used, which includes 415, 5179 and 2,880 cases in three classes, respectively. Dataset is randomly divided into 3 subsets namely, training, validation, and testing with respect to the same frequency of cases in each class to train and test the CNN model.
RESULTS


The CNN-based CAD scheme yields an overall accuracy of 94.5 % (2404/2544) with a 95 % confidence interval of [0.93,0.96] in classifying 3 classes. CAD also yields 98.4 % sensitivity (124/126) and 98.0 % specificity (2371/2418) in classifying cases with and without COVID-19 infection. However, without using two preprocessing steps, CAD yields a lower classification accuracy of 88.0 % (2239/2544).
CONCLUSION


This study demonstrates that adding two image preprocessing steps and generating a pseudo color image plays an important role in developing a deep learning CAD scheme of chest X-ray images to improve accuracy in detecting COVID-19 infected pneumonia.",2020,"The CNN-based CAD scheme yields an overall accuracy of 94.5 % (2404/2544) with a 95 % confidence interval of [0.93,0.96] in classifying 3 classes.",[],[],[],[],[],[],,0.0223987,"The CNN-based CAD scheme yields an overall accuracy of 94.5 % (2404/2544) with a 95 % confidence interval of [0.93,0.96] in classifying 3 classes.","[{'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Heidari', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA. Electronic address: Morteza.heidari@ou.edu.'}, {'ForeName': 'Seyedehnafiseh', 'Initials': 'S', 'LastName': 'Mirniaharikandehei', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}, {'ForeName': 'Abolfazl Zargari', 'Initials': 'AZ', 'LastName': 'Khuzani', 'Affiliation': 'Department of Electrical and Computer Engineering, University of California Santa Cruz, Santa Cruz, CA 95064, USA.'}, {'ForeName': 'Gopichandh', 'Initials': 'G', 'LastName': 'Danala', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}, {'ForeName': 'Yuchen', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zheng', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104284']
1911,32992151,Cost and cost-effectiveness of interim methadone treatment and patient navigation initiated in jail.,"BACKGROUND


Individuals with opioid use disorder (OUD) who are released from pre-trial detention in jail have a high risk of opioid relapse. While several interventions for OUD initiated during incarceration have been studied, few have had an economic evaluation. As part of a three-group randomized trial, we estimated the cost and cost-effectiveness of a negative urine opioid test. Detainees were assigned to interim methadone (IM) in jail with continued methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group.
METHODS


We implemented a micro-costing approach from the provider's perspective to estimate the cost per participant in jail and over the 12 months post-release from jail. Economic data included jail-based and community-based service utilization, self-reported healthcare utilization and justice system involvement, and administrative arrest records. Our outcome measure is the number of participants with a negative opioid urine test at their 12-month follow-up. We calculated incremental cost-effectiveness ratios (ICERs) for intervention costs only and costs from a societal perspective.
RESULTS


The average cost of providing patient navigation services per individual beginning in jail and continuing in the community was $283. We find that IM is dominated by ETAU and IM + PN. Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
CONCLUSIONS


IM + PN is almost certainly the cost-effective choice from both an intervention provider and societal perspective.",2020,"Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
","['patient navigation initiated in jail', 'Individuals with opioid use disorder (OUD']","['interim methadone', 'methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group', 'negative urine opioid test']","['incremental cost-effectiveness ratios (ICERs', 'average cost of providing patient navigation services', 'cost and cost-effectiveness', 'Cost and cost-effectiveness']","[{'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",,0.0840355,"Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
","[{'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Zarkin', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Orme', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States. Electronic address: sorme@rti.org.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Dunlap', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Kelly', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}, {'ForeName': 'Shannon G', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'Department of Psychology, University of Maryland, College Park, 4094 Campus Drive, College Park, MD 20742, United States.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108292']
1912,32992159,Is directed open-glottis pushing more effective than directed closed-glottis pushing during the second stage of labor? A pragmatic randomized trial - the EOLE study.,"OBJECTIVE


To compare the effectiveness of directed open-glottis and directed closed-glottis pushing.
DESIGN


Pragmatic, randomised, controlled, non-blinded superiority study.
SETTINGS


Four French hospitals between July 2015 and June 2017 (2 academic hospitals and 2 general hospitals).
PARTICIPANTS


250 women in labour who had undergone standardised training in the two types of pushing with a singleton fetus in cephalic presentation at term (≥37 weeks) were included by midwives and randomised; 125 were allocated to each group. The exclusion criteria were previous caesarean birth or fetal heart rate anomaly. Participants were randomised during labour, after a cervical dilation ≥ 7 cm.
INTERVENTIONS


In the intervention group, open-glottis pushing was defined as a prolonged exhalation contracting the abdominal muscles (pulling the stomach in) to help move the fetus down the birth canal. Closed-glottis pushing was defined as Valsalva pushing.
MEASUREMENTS


The principal outcome was ""effectiveness of pushing"" defined as a spontaneous birth without any episiotomy, second-, third-, or fourth-degree perineal lesion. The results in our intention-to-treat analysis are reported as crude relative risks (RR) with their 95% confidence intervals. A multivariable analysis was used to take the relevant prognostic and confounding factors into account and obtain an adjusted relative risk (aRR).
FINDINGS


In our intention-to-treat analysis, most characteristics were similar across groups including epidural analgesia (>95% in each group). The mean duration of the expulsion phase was longer among the open-glottis group (24.4 min ± 17.4 vs. 18.0 min ± 15.0, p=0.002). The two groups did not appear to differ in the effectiveness of their pushing (48.0% in the open-glottis group versus 55.2% in the closed-glottis group, for an adjusted relative risk (aRR) of 0.92, 95% confidence interval (CI) 0.74-1.14) or in their risk of instrumental birth (aRR 0.97, 95%CI 0.85-1.10).
KEY CONCLUSIONS


In maternity units with a high rate of epidural analgesia, the effectiveness of the type of directed pushing does not appear to differ between the open- and closed-glottis groups.
IMPLICATIONS FOR PRACTICE


If directed pushing is necessary, women should be able to choose the type of directed pushing they prefer to use during birth. Professionals must therefore be trained in both types so that they can adequately support women as they give birth.",2020,"The two groups did not appear to differ in the effectiveness of their pushing (48.0% in the open-glottis group versus 55.2% in the closed-glottis group, for an adjusted relative risk (aRR) of 0.92, 95% confidence interval (CI) 0.74-1.14) or in their risk of instrumental birth (aRR 0.97, 95%CI 0.85-1.10).
","['Four French hospitals between July 2015 and June 2017 (2 academic hospitals and 2 general hospitals', '250 women in labour who had undergone standardised training in the two types of pushing with a singleton fetus in cephalic presentation at term (≥37 weeks) were included by midwives and randomised; 125 were allocated to each group']",['directed open-glottis and directed closed-glottis pushing'],"['mean duration of the expulsion phase', 'effectiveness of pushing"" defined as a spontaneous birth without any episiotomy, second-, third-, or fourth-degree perineal lesion', 'effectiveness of their pushing', 'epidural analgesia', 'caesarean birth or fetal heart rate anomaly']","[{'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",250.0,0.172721,"The two groups did not appear to differ in the effectiveness of their pushing (48.0% in the open-glottis group versus 55.2% in the closed-glottis group, for an adjusted relative risk (aRR) of 0.92, 95% confidence interval (CI) 0.74-1.14) or in their risk of instrumental birth (aRR 0.97, 95%CI 0.85-1.10).
","[{'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Barasinski', 'Affiliation': 'Université Clermont Auvergne, CHU, CNRS, SIGMA Clermont, Institut Pascal, F-63000, CLERMONT-FERRAND, France. Electronic address: cbarasinski@chu-clermontferrand.fr.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Debost-Legrand', 'Affiliation': ""Université Clermont Auvergne, CHU, CNRS, SIGMA Clermont, Institut Pascal, F-63000, CLERMONT-FERRAND, France; Réseau de Santé en Périnatalité d'Auvergne, F-63000, Clermont-Ferrand, France.""}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Vendittelli', 'Affiliation': ""Université Clermont Auvergne, CHU, CNRS, SIGMA Clermont, Institut Pascal, F-63000, CLERMONT-FERRAND, France; Réseau de Santé en Périnatalité d'Auvergne, F-63000, Clermont-Ferrand, France; AUDIPOG (Association des Utilisateurs de Dossiers Informatisés en Pédiatrie, Obstétrique et Gynécologie), RTH Laennec Medical University, 7 rue Guillaume Paradin, 69372, Lyon Cedex 08, France.""}]",Midwifery,['10.1016/j.midw.2020.102843']
1913,32992184,Immediate Effects of Plantar Vibration on Fall Risk and Postural Stability in Stroke Patients: A Randomized Controlled Trial.,"BACKGROUND


Local vibration can improve balance problems of individuals with stroke when applied to the plantar region.
AIMS


This study aimed to determine the immediate effect of local vibration applied to the plantar region on fall risk and postural stability in patients with stroke.
STUDY DESIGN


Randomized controlled study.
METHODS


30 patients (23 male,7 female) with stroke were randomized to either vibration (n = 15; 58.47 ± 8.23 years) or control (n = 15; 58.27 ± 9.50 years) groups. Before and after the intervention, the patients were evaluated using a Biodex Balance System. Local vibration was applied to the plantar region of two feet in the supine position using a vibration device for a total of 15 min to the individuals in the vibration group. While the patients in the placebo group were in the supine position, the device was brought into contact and no vibration was applied to the plantar region of two feet for 15 min.
RESULTS


While significant improvements were observed in the postural stability and fall risk of the vibration group (p < 0.05), no significant change was observed in the placebo group (p > 0.05). Furthermore, significant improvements occurred in the SD values of the postural stability expressing postural oscillation in the vibration group (p < 0.05).
CONCLUSION


As a result of local vibration applied to the plantar region, immediate (within 5 min) significant improvements in postural stability and fall risk values were detected.",2020,"While significant improvements were observed in the postural stability and fall risk of the vibration group (p < 0.05), no significant change was observed in the placebo group (p > 0.05).","['individuals with stroke', '30 patients (23 male,7 female) with stroke', 'Stroke Patients', 'patients with stroke']","['placebo', 'local vibration', 'Plantar Vibration', 'vibration']","['fall risk and postural stability', 'SD values of the postural stability expressing postural oscillation', 'postural stability and fall risk', 'postural stability and fall risk values', 'Fall Risk and Postural Stability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}]","[{'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}]",30.0,0.0194722,"While significant improvements were observed in the postural stability and fall risk of the vibration group (p < 0.05), no significant change was observed in the placebo group (p > 0.05).","[{'ForeName': 'Birol', 'Initials': 'B', 'LastName': 'Önal', 'Affiliation': 'Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Ankara, Turkey. Electronic address: fztbirolonal@gmail.com.'}, {'ForeName': 'Gülten', 'Initials': 'G', 'LastName': 'Karaca', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Ankara Memorial Hospital, Ankara, Turkey. Electronic address: gulten2013@yahoo.com.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Sertel', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Kırıkkale University Faculty of Health Sciences, Kırıkkale, Turkey. Electronic address: fzt_meralaksehir@hotmail.com.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105324']
1914,32993343,Vitamin E-doped total hip arthroplasty liners show similar head penetration to highly cross-linked polyethylene at five years: a multi-arm randomized controlled trial.,"AIMS


The most frequent indication for revision surgery in total hip arthroplasty (THA) is aseptic loosening. Aseptic loosening is associated with polyethylene liner wear, and wear may be reduced by using vitamin E-doped liners. The primary objective of this study was to compare proximal femoral head penetration into the liner between a) two cross-linked polyethylene (XLPE) liners (vitamin E-doped (vE-PE)) versus standard XLPE liners, and b) two modular femoral head diameters (32 mm and 36 mm).
METHODS


Patients scheduled for a THA were randomized to receive a vE-PE or XLPE liner with a 32 mm or 36 mm metal head (four intervention groups in a 2 × 2 factorial design). Head penetration and acetabular component migration were measured using radiostereometric analysis at baseline, three, 12, 24, and 60 months postoperatively. The Harris Hip Score, University of California, Los Angeles (UCLA) Activity Score, EuroQol five-dimension questionnaire (EQ-5D), and 36-Item Short-Form Health Survey questionnaire (SF-36) were assessed at baseline, three, 12, 36, and 60 months.
RESULTS


Of 220 screened patients, 127 were included in this study. In all, 116 received the allocated intervention, and 94 had their results analyzed at five years. Head penetration was similar between liner materials and head sizes at five years, vE-PE versus XLPE was -0.084 mm (95% confidence interval (CI) -0.173 to 0.005; p = 0.064), and 32 mm versus 36 mm was -0.020 mm (95% CI -0.110 to 0.071; p = 0.671), respectively. No differences were found in acetabular component migration or in the patient-reported outcome measures.
CONCLUSION


No significant difference in head penetration was found at five years between vE-PE and XLPE liners, nor between 32 mm and 36 mm heads. Cite this article:  Bone Joint J  2020;102-B(10):1303-1310.",2020,"Head penetration was similar between liner materials and head sizes at five years, vE-PE versus XLPE was -0.084 mm (95% confidence interval (CI) -0.173 to 0.005; p = 0.064), and 32 mm versus 36 mm was -0.020 mm (95% CI -0.110 to 0.071; p = 0.671), respectively.","['Patients scheduled for a THA', '220 screened patients']","['vE-PE or XLPE liner with a 32 mm or 36 mm metal head', 'Vitamin E-doped total hip arthroplasty liners', 'cross-linked polyethylene (XLPE) liners (vitamin E-doped (vE-PE)) versus standard XLPE liners, and b) two modular femoral head diameters']","['head penetration', 'Harris Hip Score, University of California, Los Angeles (UCLA', 'Head penetration and acetabular component migration', 'acetabular component migration', 'Head penetration', 'Activity Score, EuroQol five-dimension questionnaire (EQ-5D), and 36-Item Short-Form Health Survey questionnaire (SF-36']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0039245', 'cui_str': 'Tacrine'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0181663', 'cui_str': 'Liner'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]","[{'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2733251', 'cui_str': 'EuroQoL five dimension questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.243059,"Head penetration was similar between liner materials and head sizes at five years, vE-PE versus XLPE was -0.084 mm (95% confidence interval (CI) -0.173 to 0.005; p = 0.064), and 32 mm versus 36 mm was -0.020 mm (95% CI -0.110 to 0.071; p = 0.671), respectively.","[{'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Kjærgaard', 'Affiliation': 'Orthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Ding', 'Affiliation': 'Orthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Jensen', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Bragdon', 'Affiliation': 'Harris Orthopaedic Laboratory, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Malchau', 'Affiliation': 'Harris Orthopaedic Laboratory, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Andreasen', 'Affiliation': 'Orthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Ovesen', 'Affiliation': 'Orthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hofbauer', 'Affiliation': 'Department of Orthopaedic Surgery, Vejle Hospital, Vejle, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Overgaard', 'Affiliation': 'Orthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark.'}]",The bone & joint journal,['10.1302/0301-620X.102B10.BJJ-2020-0138.R1']
1915,32993359,Effect of Court-Type Thai Traditional Massage Versus Senokot Treatment on Chronic Constipation: A Randomized Controlled Trial.,"Chronic constipation is the disturbances of intestinal motility which is a challenge in primary healthcare around the world. In this study, Court-type Thai traditional massage and Senokot, treatments were assessed and compared in terms of their efficacy in relieving constipation. Forty subjects diagnosed with constipation were recruited and randomized into the massage group and drug group. For 7 days, Thai traditional abdominal massage was provided regularly for the patients in the massage group, while the drug group was subjected to Senokot treatment only. The Bristol stool chart scale and demographics questionnaire were used as instruments. As a result, both court type Thai traditional massage and Senokot are effective in relieving constipation. However, although both treatment options can increase the frequency of defecations and the sensation of complete evacuation, the court type Thai traditional massage seems to be better since it leads to normal defecations rather than watery or entirely liquid defecations with no solid pieces ( p  < 0.05). This randomized controlled trial suggested that Thai traditional abdominal massage can be used as an optional public health treatment for constipation.",2020,"However, although both treatment options can increase the frequency of defecations and the sensation of complete evacuation, the court type Thai traditional massage seems to be better since it leads to normal defecations rather than watery or entirely liquid defecations with no solid pieces ( p  < 0.05).","['Chronic Constipation', 'Forty subjects diagnosed with constipation']","['Thai traditional abdominal massage', 'Court-Type Thai Traditional Massage Versus Senokot Treatment']",['Bristol stool chart scale and demographics questionnaire'],"[{'cui': 'C0401149', 'cui_str': 'Chronic constipation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]","[{'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C2316341', 'cui_str': 'Massage of abdomen'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0699932', 'cui_str': 'Senokot'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",40.0,0.030639,"However, although both treatment options can increase the frequency of defecations and the sensation of complete evacuation, the court type Thai traditional massage seems to be better since it leads to normal defecations rather than watery or entirely liquid defecations with no solid pieces ( p  < 0.05).","[{'ForeName': 'Jurairat', 'Initials': 'J', 'LastName': 'Boonruab', 'Affiliation': 'Department of Applied Thai Traditional Medicine, Faculty of Medicine, Thammasat University, Pathumthani, Thailand.'}, {'ForeName': 'Phiyaphon', 'Initials': 'P', 'LastName': 'Poonsuk', 'Affiliation': 'Department of Applied Thai Traditional Medicine, Faculty of Medicine, Thammasat University, Pathumthani, Thailand.'}, {'ForeName': 'Watchara', 'Initials': 'W', 'LastName': 'Damjuti', 'Affiliation': 'Department of Applied Thai Traditional Medicine, Thai Traditional Medicine College, Rajamangala University of Technology Thanyaburi, Pathumthani, Thailand.'}]",Journal of evidence-based integrative medicine,['10.1177/2515690X20960644']
1916,32996128,Evaluation of poly lactic-co-glycolic acid-coated β-tricalcium phosphate for alveolar ridge preservation: A multicenter randomized controlled trial.,"BACKGROUND


Alveolar ridge preservation via socket grafting (ARP-SG) is indicated to attenuate physiologic alveolar bone resorption as a consequence of tooth extraction. However, a specific bone grafting material that is patently superior has not been identified yet. The aim of this randomized controlled trial was to evaluate the efficacy of a moldable alloplastic graft, Poly Lactic-Co-Glycolic Acid-Coated β-Tricalcium Phosphate (PLGA-β-TCP), for ARP purposes [Group A] compared to freeze-dried bone allograft (FDBA) particles covered with a rapidly absorbable collagen dressing (RACD) (Group B) in function of a panel of radiographic, histomorphometric, and implant-related outcomes.
METHODS


Patients in need of extraction of a single posterior tooth (premolar or molar) and subsequent replacement with a dental implant were recruited and randomly allocated into one of the two treatment groups. Follow-up visits took place at 1, 2, 4, 8, and 16 weeks. Cone-beam Computed Tomography (CBCT) scans were obtained at baseline and at 16 weeks. Sites were re-entered at 20 weeks for bone core biopsy harvesting and subsequent implant placement. After delivery of the final implant-supported restoration, follow-up visits were scheduled at 6 and 12 months to monitor peri-implant tissue health and marginal bone levels using standardized intraoral periapical radiographs.
RESULTS


A total of 45 patients were initially enrolled in the study, of whom 43 received an implant and 32 completed the study. Healing was uneventful in all sites after ARP-SG and implant placement. No site required bone augmentation to allow for implant placement. CBCT scan analyses showed no statistically significant differences between groups in terms of reduction of horizontal width, midbuccal / midlingual height and ridge volume. Histomorphometric assessments revealed a statistically significant difference between both groups in terms of mineralized tissue formation (Group A = 27.0% ± 22.1% versus Group B = 38.2% ± 12.5%; P < 0.05). On the contrary, no significant differences were observed regarding percent of remaining bone grafting material and non-mineralized tissue. No implant failed throughout the study period and marginal bone level change was negligible in both groups.
CONCLUSIONS


Although a higher proportion of mineralized tissue was associated with the use of FDBA+RACD compared to PLGA-β-TCP alone, both ARP-SG approaches rendered comparable outcomes in terms of maintenance of alveolar bone dimensions, feasibility of implant placement, implant survival, and peri-implant bone level stability up to 12 months post-loading.",2020,"CBCT scan analyses showed no statistically significant differences between groups in terms of reduction of horizontal width, midbuccal / midlingual height and ridge volume.","['Patients in need of extraction of a single posterior tooth (premolar or molar) and subsequent replacement with a dental implant', 'alveolar ridge preservation', 'A total of 45 patients were initially enrolled in the study, of whom 43 received an implant and 32 completed the study']","['poly Lactic-co-glycolic Acid-coated β-tricalcium phosphate', 'FDBA+RACD', 'Poly Lactic-Co-Glycolic Acid-Coated β-Tricalcium Phosphate (PLGA-β-TCP', 'PLGA-β-TCP', 'Cone-beam Computed Tomography (CBCT) scans', 'socket grafting (ARP-SG', 'freeze-dried bone allograft (FDBA) particles covered with a rapidly absorbable collagen dressing (RACD']","['remaining bone grafting material and non-mineralized tissue', 'reduction of horizontal width, midbuccal / midlingual height and ridge volume', 'marginal bone level change', 'alveolar bone dimensions, feasibility of implant placement, implant survival and peri-implant bone level stability', 'Healing', 'mineralized tissue formation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1533643', 'cui_str': 'Glycolic acid'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0108136', 'cui_str': 'tricalcium phosphate'}, {'cui': 'C0016698', 'cui_str': 'Lyophilization'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0460884', 'cui_str': 'Collagen dressing'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C2354284', 'cui_str': 'socket graft'}, {'cui': 'C0407564', 'cui_str': 'Allogeneic bone graft'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}]","[{'cui': 'C0181075', 'cui_str': 'Bone graft material'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",45.0,0.0886669,"CBCT scan analyses showed no statistically significant differences between groups in terms of reduction of horizontal width, midbuccal / midlingual height and ridge volume.","[{'ForeName': 'Hanae', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, Division of Periodontics, School of Dentistry, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Couso-Queiruga', 'Affiliation': 'Department of Periodontics, College of Dentistry, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Harlan J', 'Initials': 'HJ', 'LastName': 'Shiau', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, Division of Periodontics, School of Dentistry, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Stuhr', 'Affiliation': 'Department of Periodontics, College of Dentistry, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Prasad', 'Affiliation': 'Hard Tissue Research Laboratory, The University of Minnesota School of Dentistry, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Trishul V', 'Initials': 'TV', 'LastName': 'Allareddy', 'Affiliation': 'Department of Oral Pathology, Radiology and Medicine, College of Dentistry, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Reynolds', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, Division of Periodontics, School of Dentistry, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Avila-Ortiz', 'Affiliation': 'Department of Periodontics, College of Dentistry, University of Iowa, Iowa City, Iowa, USA.'}]",Journal of periodontology,['10.1002/JPER.20-0360']
1917,32997088,Effect of glazing application side and mechanical cycling on the biaxial flexural strength and Weibull characteristics of a Y-TZP ceramic.,"OBJECTIVE


Glaze application on monolithic zirconia (Y-TZP) can be a practical approach to improve the mechanical properties of this material. Our study evaluated the effect of glazing side and mechanical cycling on the biaxial flexure strength (BFS) of a Y-TZP.
METHODOLOGY


Eighty sintered Y-TZP discs (Ø:12 mm; thickness: 1.2 mm - ISO 6872) were produced and randomly assigned into eight groups (n=10), according to the factors ""glazing side"" (control - no glazing; GT - glaze on tensile side; GC - glaze on compression side; GTC - glaze on both sides) and ""mechanical aging"" (non-aged and aged, A - mechanical cycling: 1.2×106, 84 N, 3 Hz, under water at 37°C). Specimens were subjected to BFS test (1 mm/min; 1,000 Kgf load cell) and fractured surfaces were analyzed by stereomicroscopy and SEM. Hsueh's rigorous solutions were used to estimate the stress at failure of glazed specimens. Two-way ANOVA, Tukey's test (5%), and Weibull analysis were performed.
RESULTS


The ""glazing side"", ""mechanical aging"" and the interaction of the factors were significant (p<0.05). Groups GC (1157.9±146.9 MPa), GT (1156.1±195.3 MPa), GTC (986.0±187.4 MPa) and GTC-A (1131.9±128.9 MPa) presented higher BFS than control groups (Tukey, 5%). Hsueh's rigorous solutions showed that the maximum tensile stress was presented in the bottom of zirconia layer, at the zirconia/glaze interface. Weibull characteristic strength (σo) of the GC was higher than all groups (p<0.05), except to GT, GTC-A and GTC, which were similar among them. The fractography showed initiation of failures from zirconia the tensile side regardless of the side of glaze application and fatigue.
CONCLUSION


Glazing zirconia applied on both tensile and compression sides improves the flexural strength of Y-TZP, regardless the mechanical aging.",2020,"Weibull characteristic strength (σo) of the GC was higher than all groups (p<0.05), except to GT, GTC-A and GTC, which were similar among them.","['Eighty sintered Y-TZP discs (Ø:12 mm; thickness: 1.2 mm - ISO 6872', 'non-aged and aged, A - mechanical cycling: 1.2×106, 84 N, 3 Hz, under water at 37°C']","['glazing application side and mechanical cycling', 'Glazing zirconia', 'glazing side and mechanical cycling', 'factors ""glazing side', 'mechanical aging']","['Weibull characteristic strength (σo) of the GC', 'biaxial flexure strength (BFS', 'flexural strength', 'maximum tensile stress', 'biaxial flexural strength and Weibull characteristics of a Y-TZP ceramic']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}]","[{'cui': 'C4704755', 'cui_str': 'Fracture Strength'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1567733', 'cui_str': 'yttria stabilized tetragonal zirconia'}]",6872.0,0.017049,"Weibull characteristic strength (σo) of the GC was higher than all groups (p<0.05), except to GT, GTC-A and GTC, which were similar among them.","[{'ForeName': 'Carolina Machado Martinelli', 'Initials': 'CMM', 'LastName': 'Lobo', 'Affiliation': 'Universidade Estadual Paulista Júlio de Mesquita Filho (UNESP), Instituto de Ciência e Tecnologia, Departamento de Materiais Dentários e Prótese, São José dos Campos, São Paulo, Brasil.'}, {'ForeName': 'Sâmia Carolina Mota Cavalcanti', 'Initials': 'SCMC', 'LastName': 'Sacorague', 'Affiliation': 'Universidade Estadual Paulista Júlio de Mesquita Filho (UNESP), Instituto de Ciência e Tecnologia, Departamento de Materiais Dentários e Prótese, São José dos Campos, São Paulo, Brasil.'}, {'ForeName': 'Nathalia Ramos da', 'Initials': 'NRD', 'LastName': 'Silva', 'Affiliation': 'Universidade Federal do Rio Grande do Norte (UFRN), Departamento de Odontologia, Natal, Rio Grande do Norte, Brasil.'}, {'ForeName': 'Anna Karina Figueiredo', 'Initials': 'AKF', 'LastName': 'Costa', 'Affiliation': 'Universidade Estadual Paulista Júlio de Mesquita Filho (UNESP), Instituto de Ciência e Tecnologia, Departamento de Materiais Dentários e Prótese, São José dos Campos, São Paulo, Brasil.'}, {'ForeName': 'Larissa Marcia Martins', 'Initials': 'LMM', 'LastName': 'Alves', 'Affiliation': 'Universidade Estadual Paulista Júlio de Mesquita Filho (UNESP), Instituto de Ciência e Tecnologia, Departamento de Materiais Dentários e Prótese, São José dos Campos, São Paulo, Brasil.'}, {'ForeName': 'Marco Antônio', 'Initials': 'MA', 'LastName': 'Bottino', 'Affiliation': 'Universidade Estadual Paulista Júlio de Mesquita Filho (UNESP), Instituto de Ciência e Tecnologia, Departamento de Materiais Dentários e Prótese, São José dos Campos, São Paulo, Brasil.'}, {'ForeName': 'Mutlu', 'Initials': 'M', 'LastName': 'Özcan', 'Affiliation': 'University of Zurich, Center for Dental and Oral Medicine, Division of Dental Biomaterials, Clinic for Reconstructive Dentistry, Zurich, Switzerland.'}, {'ForeName': 'Rodrigo Othávio de Assunção E', 'Initials': 'ROAE', 'LastName': 'Souza', 'Affiliation': 'Universidade Federal do Rio Grande do Norte (UFRN), Departamento de Odontologia, Natal, Rio Grande do Norte, Brasil.'}, {'ForeName': 'Renata Marques de', 'Initials': 'RM', 'LastName': 'Melo', 'Affiliation': 'Universidade Estadual Paulista Júlio de Mesquita Filho (UNESP), Instituto de Ciência e Tecnologia, Departamento de Materiais Dentários e Prótese, São José dos Campos, São Paulo, Brasil.'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2020-0438']
1918,32680912,Impact of Improved Biomass and Liquid Petroleum Gas Stoves on Birth Outcomes in Rural Nepal: Results of 2 Randomized Trials.,"BACKGROUND


Few randomized trials have assessed the impact of reducing household air pollution from biomass stoves on adverse birth outcomes in low-income countries.
METHODS


Two sequential trials were conducted in rural low-lying Nepal. Trial 1 was a cluster-randomized step-wedge trial comparing traditional biomass stoves and improved biomass stoves vented with a chimney. Trial 2 was a parallel household-randomized trial comparing vented biomass stoves and liquid petroleum gas (LPG) stoves with a year's supply of gas. Kitchen particulate matter of 2.5 μm or less (PM 2.5 ) and carbon monoxide (CO) were assessed before and after stove installation. Prevalent and incident pregnancies were enrolled at baseline and throughout the trials. Birth anthropometry was compared across differing exposure times in pregnancy.
RESULTS


In trial 1, the mean 20-hour kitchen PM 2.5  concentration was reduced from 1380 µg/m 3  to 936 µg/m 3 . Among infants born before the intervention, mean birth weight and gestational age were 2627 g (SD=443) and 38.8 weeks (SD=3.1), and 39% were low birth weight (LBW), 22% preterm, and 55% small for gestational age (SGA). Adverse birth outcomes were not significantly different with increasing exposure to improved stoves during pregnancy. In trial 2, the mean 20-hour PM 2.5  concentration was 885 µg/m 3  in households with vented biomass and 442 µg/m 3  in those with LPG stoves. Mean birth weight was 2780 g (SD=427) and 2742 g (SD=431), among households with vented and LPG stoves, respectively. Respective percentages for LBW, SGA, and preterm were 23%, 13%, and 42% in the vented stove group and not statistically different from 31%, 17%, and 42% in the LPG group.
CONCLUSIONS


Improved biomass or LPG stoves did not reduce adverse birth outcomes. PM 2.5  and CO following improved stove installation remained well above the World Health Organization indoor air standard of 25 µg/m 3  or intermediate air quality guideline of 37.5 µg/m 3 . Trials that lower indoor air pollution further are needed.",2020,PM 2.5  and CO following improved stove installation remained well above the World Health Organization indoor air standard of 25 µg/m 3  or intermediate air quality guideline of 37.5 µg/m 3 .,"['Two sequential trials were conducted in rural low-lying Nepal', 'infants born before the intervention, mean birth weight and gestational age were 2627 g (SD=443) and 38.8 weeks (SD=3.1), and 39% were low birth weight (LBW), 22% preterm, and 55% small for gestational age (SGA', 'low-income countries', 'Rural Nepal']","['household air pollution from biomass stoves', 'traditional biomass stoves and improved biomass stoves vented with a chimney', 'Improved Biomass and Liquid Petroleum Gas Stoves', ""vented biomass stoves and liquid petroleum gas (LPG) stoves with a year's supply of gas""]","['adverse birth outcomes', 'LBW, SGA, and preterm', 'Mean birth weight', 'mean 20-hour kitchen PM 2.5  concentration', 'carbon monoxide (CO', 'Adverse birth outcomes']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0336754', 'cui_str': 'Stove'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0557689', 'cui_str': 'Chimney'}, {'cui': 'C3463996', 'cui_str': 'Liquid Petroleum'}, {'cui': 'C1268549', 'cui_str': 'Gas stove'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0557653', 'cui_str': 'Kitchen'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}]",,0.215707,PM 2.5  and CO following improved stove installation remained well above the World Health Organization indoor air standard of 25 µg/m 3  or intermediate air quality guideline of 37.5 µg/m 3 .,"[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. jkatz1@jhu.edu.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Tielsch', 'Affiliation': 'Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Subarna K', 'Initials': 'SK', 'LastName': 'Khatry', 'Affiliation': 'Nepal Nutrition Intervention Project, Sarlahi, Kathmandu, Nepal.'}, {'ForeName': 'Laxman', 'Initials': 'L', 'LastName': 'Shrestha', 'Affiliation': 'Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Breysse', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Zeger', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kozuki', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'LeClerq', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Mullany', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]","Global health, science and practice",['10.9745/GHSP-D-20-00011']
1919,32991450,Antiretroviral treatment and its impact on oral health outcomes in 5 to 7 year old Ugandan children: A 6 year follow-up visit from the ANRS 12174 randomized trial.,"BACKGROUND


Antiretroviral therapy for HIV in sub-Saharan Africa has transformed the highly infectious virus to a stable chronic condition, with the advent of Highly active antiretroviral therapy (HAART). The longterm effects of HAART on the oral health of children are understudied.
OBJECTIVE


To compare the effect of lopinavir-ritonavir and lamivudine on oral health indicators (dental caries, gingivitis, tooth eruption, and oral health related quality of life) in 5 to 7 year old HIV-1 exposed uninfected children from the ANRS 12174 trial.
METHODS


This study used data collected in 2017 among children aged 5 to 7 years from the Ugandan site of the ANRS 12174 randomized trial (ClinicalTrials.gov no: NCT00640263) implemented between 2009 and 2012 in Mbale district, Eastern Uganda. The intervention was lopinavir-ritonavir or lamuvudine treatment to prevent vertical HIV-1 transmission. One hundred thirty-seven and 139 children were randomized to receive lopinavir-ritonavir or lamivudine treatment at day 7 postpartum to compare efficacy of prevention of vertical HIV-1 transmission. At follow up, the children underwent oral examination using the World Health Organization methods for field conditions. The oral health related quality of life was assessed using the early childhood oral health impact scale. Negative binomial and logistic regression were used for the analysis of data.
MAIN OUTCOME MEASURES


Dental caries, gingivitis, tooth eruption, and oral health related quality of life) in 5 to 7 year old HIV-1 exposed uninfected children.
RESULTS


The prevalence of dental caries was 48% in the study sample: 49% in the lopinavir-ritonavir arm and 48% in the lamivudine treatment group. The corresponding mean decayed missing filled teeth and standard deviation was 1.7 (2.4) and 2.3 (3.7) The mean number (standard deviation) of erupted permanent teeth was 3.8 (3.7) and 4.6 (3.9) teeth in the lopinavir- and lamivudine group, respectively. The prevalence of reported impacts on oral health was 7% in the lopinavir-ritonavir and 18% in the lamivudine group. Gingivitis had a prevalence of 7% in the lopinavir-ritonavir and 14% lamivudine treatment group. The regression analysis revealed 70% less reported impacts on oral health in lopinavir-ritonavir group than the lamivudine treatment group with an incidence rate ratio of 0.3 (95% confidence interval: 0.1-0.9).
CONCLUSIONS


HIV exposed uninfected infants in the lopinavir-ritonavir group reported less impacts on oral health than the lamivudine treatment group. Dental caries, gingivitis, and tooth eruption were not significantly affected by the treatment lopinavir-ritonavir or lamivudine. TRIAL REGISTRATION CLINICALTRIALS.
GOV IDENTIFIER


NCT00640263.",2020,"Dental caries, gingivitis, and tooth eruption were not significantly affected by the treatment lopinavir-ritonavir or lamivudine.","['5 to 7 year old HIV-1 exposed uninfected children from the ANRS 12174 trial', 'One hundred thirty-seven and 139 children', '2017 among children aged 5 to 7 years from the Ugandan site of the ANRS 12174 randomized trial (ClinicalTrials.gov no: NCT00640263) implemented between 2009 and 2012 in Mbale district, Eastern Uganda', '5 to 7 year old Ugandan children']","['HAART', 'lopinavir-ritonavir', 'lopinavir-ritonavir or lamuvudine', 'lopinavir-ritonavir and lamivudine', 'lamivudine', 'lopinavir-ritonavir or lamivudine']","['prevalence of dental caries', 'Dental caries, gingivitis, and tooth eruption', 'Dental caries, gingivitis, tooth eruption, and oral health related quality of life', 'mean number (standard deviation) of erupted permanent teeth', 'oral health outcomes', 'oral health indicators (dental caries, gingivitis, tooth eruption, and oral health related quality of life', 'oral health']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0887947', 'cui_str': 'Highly active anti-retroviral therapy'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0040437', 'cui_str': 'Tooth erupted'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",139.0,0.165706,"Dental caries, gingivitis, and tooth eruption were not significantly affected by the treatment lopinavir-ritonavir or lamivudine.","[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Birungi', 'Affiliation': 'Department of Clinical Dentistry.'}, {'ForeName': 'Lars T', 'Initials': 'LT', 'LastName': 'Fadnes', 'Affiliation': 'Center for international health, Department of Global Health and Primary Health Care, University of Bergen.'}, {'ForeName': 'Ingunn M S', 'Initials': 'IMS', 'LastName': 'Engebretsen', 'Affiliation': 'Department of Global Health and Primary Health Care.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Tumwine', 'Affiliation': 'Department of Pediatrics and Child Health, School of Medicine, College of Health Sciences, Makerere University Kampala, Uganda.'}, {'ForeName': 'Anne Nordrehaug', 'Initials': 'AN', 'LastName': 'Åstrøm', 'Affiliation': 'Department of Clinical Dentistry.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022352']
1920,32991458,Long-term effects of a food pattern on cardiovascular risk factors and age-related changes of muscular and cognitive function.,"INTRODUCTION


The mean age of the German population increased over the last years, which resulted in a higher prevalence of cardiovascular diseases, type 2 diabetes, cognitive impairment, sarcopenia and bone fractures. Current evidence indicates a preservation of human wellbeing in the elderly by a healthy diet, although the recommended macronutrient composition and quality remains unclear and needs further long-term investigation. In this context we investigate the effect of a specific dietary pattern on age-related disorders in a randomized controlled multi-center trial (RCT).
METHODS


We assess the effect of a specific dietary pattern (NutriAct) with a high proportion of unsaturated fat, plant proteins and fibres (fat 35%-40% of total energy (%E) of which 15%E-20%E monounsaturated fatty acids (MUFA) and 10%E-15%E polyunsaturated fatty acids (PUFA), 15%E-25%E proteins, ≥30 g fibres per day and 35%E-45%E carbohydrates) on age-related impairment of health within a 36-months RCT conducted in the region of Berlin and Potsdam. 502 eligible men (n = 183) and women (n = 319), aged 50 to 80 years, with an increased risk to develop age-related diseases were randomly assigned to either an intervention group focusing on NutriAct dietary pattern or a control group focusing on usual care and dietary recommendations in accordance to the German Nutrition Society (DGE). In the intervention group, 21 nutrition counsellings as well as supplementation of rapeseed oil, oil cake and specific designed foods are used to achieve the intended NutriAct dietary pattern.The primary outcome is a composite endpoint of age-related disorders, including cardiovascular morbidity, decline of cognitive function as well as clinical features of sarcopenia. Secondary outcomes include diet-induced effects on quality of life, depression, frailty, cardiovascular function, bone density, fat distribution pattern, glucose, lipid and energy metabolism, as well as the identification of biomarkers linked with age-related disorders.
DISCUSSION


The findings of this trial will provide clinically relevant information regarding dietary effects on age-related impairment of health and will contribute to the definition of the optimal macronutrient composition in the context of healthy aging in the German population.",2020,"The mean age of the German population increased over the last years, which resulted in a higher prevalence of cardiovascular diseases, type 2 diabetes, cognitive impairment, sarcopenia and bone fractures.","['502 eligible men (n\u200a=\u200a183) and women (n\u200a=\u200a319), aged 50 to 80 years, with an increased risk to develop age-related diseases', 'age-related impairment of health within a 36-months RCT conducted in the region of Berlin and Potsdam']","['specific dietary pattern (NutriAct) with a high proportion of unsaturated fat, plant proteins and fibres (fat 35%-40% of total energy (%E) of which 15%E-20%E monounsaturated fatty acids (MUFA) and 10%E-15%E polyunsaturated fatty acids (PUFA), 15%E-25%E proteins, ≥30\u200ag fibres per day and 35%E-45%E carbohydrates', 'intervention group focusing on NutriAct dietary pattern or a control group focusing on usual care and dietary recommendations in accordance to the German Nutrition Society (DGE', 'specific dietary pattern', '21 nutrition counsellings as well as supplementation of rapeseed oil, oil cake and specific designed foods']","['cardiovascular risk factors and age-related changes of muscular and cognitive function', 'cardiovascular diseases, type 2 diabetes, cognitive impairment, sarcopenia and bone fractures', 'diet-induced effects on quality of life, depression, frailty, cardiovascular function, bone density, fat distribution pattern, glucose, lipid and energy metabolism, as well as the identification of biomarkers linked with age-related disorders', 'composite endpoint of age-related disorders, including cardiovascular morbidity, decline of cognitive function as well as clinical features of sarcopenia']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015678', 'cui_str': 'Unsaturated fat'}, {'cui': 'C0032089', 'cui_str': 'Plant Proteins'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0072982', 'cui_str': 'Brassica Napus Oil'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0452597', 'cui_str': 'Cake'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0449775', 'cui_str': 'Distribution pattern'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",502.0,0.0398379,"The mean age of the German population increased over the last years, which resulted in a higher prevalence of cardiovascular diseases, type 2 diabetes, cognitive impairment, sarcopenia and bone fractures.","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Wernicke', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin.'}, {'ForeName': 'Konstantina', 'Initials': 'K', 'LastName': 'Apostolopoulou', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Hornemann', 'Affiliation': 'NutriAct-Competence Cluster Nutrition Research, Berlin-Potsdam.'}, {'ForeName': 'Andriana', 'Initials': 'A', 'LastName': 'Efthymiou', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Machann', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases (IDM) of the Helmholtz Center Munich at the University of Tübingen, Tübingen.'}, {'ForeName': 'Sein', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Clinical Research Unit, 10117 Berlin.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Primessnig', 'Affiliation': 'DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin.'}, {'ForeName': 'Manuela M', 'Initials': 'MM', 'LastName': 'Bergmann', 'Affiliation': 'Department of Clinical Nutrition, German Institute of Human Nutrition, Potsdam-Rehbruecke, Nuthetal.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Grune', 'Affiliation': 'NutriAct-Competence Cluster Nutrition Research, Berlin-Potsdam.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Gerbracht', 'Affiliation': 'Department of Clinical Nutrition, German Institute of Human Nutrition, Potsdam-Rehbruecke, Nuthetal.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Herber', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Pohrt', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Biometry and Clinical Epidemiology, Berlin, Germany.'}, {'ForeName': 'Andreas F H', 'Initials': 'AFH', 'LastName': 'Pfeiffer', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Spranger', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Mai', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin.'}]",Medicine,['10.1097/MD.0000000000022381']
1921,32991462,Perioperative analgesia after intrathecal morphine or local infiltration anesthesia for total knee replacement: A protocol for randomized controlled trial.,"OBJECTIVE


We perform this protocol for randomized controlled trial to compare the efficacy of intrathecal morphine and local infiltration anesthesia (LIA) in the treatment of the postoperative pain after total knee replacement (TKR).
METHODS


This is a randomized controlled, single center trial which was performed from March 2019 to March 2020. This trial is conducted according to the SPIRIT Checklist of randomized researches. It is authorized via the Ethics Committee of Beijing Friendship Hospital (2019-P2-050-01). Eighty participants who undergo TKR were randomized into 2 groups. Intrathecal morphine group: 0.1 mg of the morphine was intrathecally injected, and the spinal anesthetic was injected at the same time in the group LIA; In the LIA group: the knee joint was infiltrated with epinephrine, ketorologic acid and ropivacaine in the process of operation, and the identical mixture was injected 2 bolus through the intraarticular catheter after operation. The main outcome variables were the visual analog scale and the consumption amount of opioid every 6-hour interval within 2 days postoperatively. The secondary outcome variables were the side effects associated with opioid, the length of hospital stay, motion range, and the loss of blood collected by the closed suction drainage. All the required analyses were carried out via applying the SPSS for Windows Version 19.0.
RESULTS


The clinical outcome variables between groups were shown in .
CONCLUSION


This protocol will provide the evidence on which technique can achieve better analgesia after TKR.",2020,The main outcome variables were the visual analog scale and the consumption amount of opioid every 6-hour interval within 2 days postoperatively.,"['postoperative pain after total knee replacement (TKR', 'total knee replacement', 'Eighty participants who undergo TKR']","['intrathecal morphine and local infiltration anesthesia (LIA', 'epinephrine, ketorologic acid and ropivacaine', 'Intrathecal morphine', 'intrathecal morphine', 'morphine', 'local infiltration anesthesia']","['side effects associated with opioid, the length of hospital stay, motion range, and the loss of blood collected by the closed suction drainage', 'visual analog scale and the consumption amount of opioid every 6-hour interval within 2 days postoperatively']","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0198813', 'cui_str': 'Local anesthesia, by infiltration'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0585325', 'cui_str': 'Every six hours'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",80.0,0.0735529,The main outcome variables were the visual analog scale and the consumption amount of opioid every 6-hour interval within 2 days postoperatively.,"[{'ForeName': 'Zhengrong', 'Initials': 'Z', 'LastName': 'Qi', 'Affiliation': 'Department of Orthopedics, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Zhiyao', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Jingxin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022394']
1922,32991471,The acute and chronic effects of high-intensity exercise in hypoxia on blood pressure and post-exercise hypotension: A randomized cross-over trial.,"BACKGROUND


Acute exercise leads to an immediate drop in blood pressure (BP), also called post-exercise hypotension (PEH). Exercise in hypoxia is related to additional vasodilation, potentially contributing to more profound PEH. Therefore, we investigated the impact of hypoxia versus normoxia on the magnitude of PEH. Second, we examined whether these changes in PEH relate to the BP-lowering effects of 12-week exercise training under hypoxia.
METHODS


In this prospective study, 21 healthy individuals (age 22.2 ± 3.0 years, 14 male) performed a 45-minute high-intensity running exercise on 2 different days in a random order, under hypoxia (fraction of inspired oxygen 14.5%) and normoxia (fraction of inspired oxygen 20.9%). BP was examined pre-exercise (t = 0) and at t = 15, t = 30, t = 45, and t = 60 minutes post-exercise. Afterward, subjects took part in a 12-week hypoxic running exercise training program. Resting BP was measured before and after the 12-week training program.
RESULTS


Acute exercise induced a significant decrease in systolic BP (systolic blood pressure [SBP], P = .001), but not in diastolic BP (diastolic blood pressure [DBP], P = .113). No significant differences were observed in post-exercise BP between hypoxic and normoxic conditions (SBP, P = .324 and DBP, P = .204). Post-exercise changes in SBP, DBP, and mean arterial pressure significantly correlated to the 12-week exercise training-induced changes in SBP (r = 0.557, P = .001), DBP (r = 0.615, P < .001), and mean arterial pressure (r = 0.458, P = .011).
CONCLUSION


Our findings show that hypoxia does not alter the magnitude of PEH in healthy individuals, whilst PEH relates to the BP-lowering effects of exercise. These data highlight the strong link between acute and chronic changes in BP.",2020,"No significant differences were observed in post-exercise BP between hypoxic and normoxic conditions (SBP, P = .324 and DBP, P = .204).","['healthy individuals', '21 healthy individuals (age 22.2\u200a±\u200a3.0 years, 14 male']","['high-intensity exercise', 'hypoxic running exercise training program', '45-minute high-intensity running exercise']","['Resting BP', 'SBP, DBP, and mean arterial pressure', 'blood pressure (BP', 'diastolic BP (diastolic blood pressure [DBP', 'DBP ', 'systolic BP (systolic blood pressure [SBP', 'blood pressure and post-exercise hypotension', 'mean arterial pressure', 'post-exercise BP', 'BP', 'SBP']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C2936233', 'cui_str': 'Post Exercise Hypotension'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}]",21.0,0.0217924,"No significant differences were observed in post-exercise BP between hypoxic and normoxic conditions (SBP, P = .324 and DBP, P = .204).","[{'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Kleinnibbelink', 'Affiliation': 'Department of Physiology.'}, {'ForeName': 'Niels A', 'Initials': 'NA', 'LastName': 'Stens', 'Affiliation': 'Department of Physiology.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Fornasiero', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Guilherme F', 'Initials': 'GF', 'LastName': 'Speretta', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Arie P J', 'Initials': 'APJ', 'LastName': 'Van Dijk', 'Affiliation': 'Department of Cardiology, Research Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Low', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Oxborough', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Dick H J', 'Initials': 'DHJ', 'LastName': 'Thijssen', 'Affiliation': 'Department of Physiology.'}]",Medicine,['10.1097/MD.0000000000022411']
1923,32993325,Comparison of plaster-of-Paris casts and Woodcast splints for immobilization of the limb during serial manipulation and casting for idiopathic clubfoot in infants.,"AIMS


The study was undertaken to compare the efficacy of Woodcast splints and plaster-of-Paris casts in maintaining correction following sequential manipulation of idiopathic clubfeet.
METHODS


In this randomized prospective trial, 23 idiopathic clubfeet were immobilized with plaster-of-Paris casts and 23 clubfeet were immobilized with a splint made of Woodcast that encircled only two-thirds the circumference of the limb. The number of casts or splints needed to obtain full correction, the frequency of cast or splint-related complications, and the time taken for application and removal of the casts and splints were compared.
RESULTS


The mean number of casts required to obtain full correction of the deformity (Pirani Score 0) was 4.35 (95% confidence interval (CI) 3.74 to 4.95) when plaster-of-Paris was used and 4.87 (95% CI 4.33 to 5.41) when the Woodcast splint was used (p = 0.190). The time required for application and removal of the Woodcast splint were significantly less than that required for application and removal of plaster-of-Paris casts (p < 0.001). Woodcast splint-related complications were not more frequent than plaster-of-Paris cast related complications.
CONCLUSION


Though Woodcast splints covering two-thirds of the circumference of the lower limbs of infants were effective in maintaining the correction of clubfoot deformity during serial manipulation and casting treatment, the superiority of Woodcasts over plaster-of-Paris could not be established. Cite this article:  Bone Joint J  2020;102-B(10):1399-1404.",2020,The time required for application and removal of the Woodcast splint were significantly less than that required for application and removal of plaster-of-Paris casts (p < 0.001).,"['infants', '23 idiopathic clubfeet']","['plaster-of-Paris casts and Woodcast splints', 'Woodcast splints and plaster-of-Paris casts']","['time required for application and removal of the Woodcast splint', 'mean number of casts required to obtain full correction of the deformity (Pirani Score 0']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0009081', 'cui_str': 'Talipes equinovarus'}]","[{'cui': 'C0032160', 'cui_str': 'Plaster of Paris'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0038009', 'cui_str': 'Splint'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",23.0,0.0319939,The time required for application and removal of the Woodcast splint were significantly less than that required for application and removal of plaster-of-Paris casts (p < 0.001).,"[{'ForeName': 'Kumar Amerender', 'Initials': 'KA', 'LastName': 'Singh', 'Affiliation': 'Department of Orthopaedics, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Hitesh', 'Initials': 'H', 'LastName': 'Shah', 'Affiliation': 'Department of Orthopaedics, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Joseph', 'Affiliation': 'Department of Orthopaedics, Aster Medcity, Kochi, India.'}]",The bone & joint journal,['10.1302/0301-620X.102B10.BJJ-2020-0181.R4']
1924,32993326,An exploratory randomized controlled trial comparing wood-composite and synthetic fibreglass splint systems for the immobilization of paediatric upper limb fractures.,"AIMS


This exploratory randomized controlled trial (RCT) aimed to determine the splint-related outcomes when using the novel biodegradable wood-composite splint (Woodcast) compared to standard synthetic fibreglass (Dynacast) for the immobilization of undisplaced upper limb fractures in children.
METHODS


An exploratory RCT was performed at a tertiary paediatric referral hospital between 1 June 2018 and 30 September 2019. The intention-to-treat population consisted of 170 patients (mean age 8.42 years (SD 3.42); Woodcast (WCG), n = 84, 57 male (67.9%); Dynacast (DNG), n = 86, 58 male (67.4%)). Patients with undisplaced upper limb fractures were randomly assigned to WCG or DNG treatment groups. Primary outcome was the stress stability of the splint material, defined as absence of any deformations or fractures within the splint during study period. Secondary outcomes included patient satisfaction and medical staff opinion. Additionally, biomechanical and chemical analysis of the splint samples was carried out.
RESULTS


Of the initial 170 patients, 168 (98.8%) completed at least one follow-up, and were included for analysis of the primary endpoint. Both treatment groups were well-matched regarding to age, sex, and type and localization of the fracture. Splint breakage occurred in three patients (3.6%; 95% confidence interval (CI), 0.007% to 0.102%) in the WCG and in three children (3.5%, 95% CI 0.007% to 0.09%) in the DNG (p > 0.99). The incidence of splint-related adverse events did not differ between the WCG (n = 21; 25.0%) and DNG (n = 24; 27.9%; p = 0.720). Under experimental conditions, the maximal tensile strength of Dynacast samples was higher than those deriving from Woodcast (mean 15.37 N/mm² (SD 1.37) vs 10.75 N/mm² (SD 1.20); p = 0.002). Chemical analysis revealed detection of polyisocyanate-prepolymer in Dynacast and polyester in Woodcast samples.
CONCLUSION


Splint-related adverse events appear similar between WCG and DNG treatment groups during the treatment of undisplaced forearm fractures. Cite this article:  Bone Joint J  2020;102-B(10):1405-1411.",2020,"Splint breakage occurred in three patients (3.6%; 95% confidence interval (CI), 0.007% to 0.102%) in the WCG and in three children (3.5%, 95% CI 0.007% to 0.09%) in the DNG (p > 0.99).","['tertiary paediatric referral hospital between 1 June 2018 and 30 September 2019', 'undisplaced upper limb fractures in children', 'Of the initial 170 patients, 168 (98.8%) completed at least one follow-up', 'mean age 8.42 years (SD 3.42); Woodcast (WCG), n = 84, 57 male (67.9%); Dynacast (DNG), n = 86, 58 male (67.4', '170 patients ', 'Patients with undisplaced upper limb fractures', 'paediatric upper limb fractures']","['WCG or DNG', 'WCG', 'WCG and DNG', 'wood-composite and synthetic fibreglass splint systems', 'novel biodegradable wood-composite splint (Woodcast', 'standard synthetic fibreglass (Dynacast']","['Splint breakage', 'maximal tensile strength of Dynacast samples', 'adverse events', 'incidence of splint-related adverse events', 'patient satisfaction and medical staff opinion', 'stress stability of the splint material, defined as absence of any deformations or fractures']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0443336', 'cui_str': 'Undisplaced'}, {'cui': 'C0178316', 'cui_str': 'Fracture of upper limb'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517693', 'cui_str': '3.42'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0043217', 'cui_str': 'Wood'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0060317', 'cui_str': 'Fiberglass'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C1540845', 'cui_str': 'Tensile strength'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0025106', 'cui_str': 'Medical Staffs'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",3.0,0.131298,"Splint breakage occurred in three patients (3.6%; 95% confidence interval (CI), 0.007% to 0.102%) in the WCG and in three children (3.5%, 95% CI 0.007% to 0.09%) in the DNG (p > 0.99).","[{'ForeName': 'Illya', 'Initials': 'I', 'LastName': 'Martynov', 'Affiliation': 'Department of Pediatric Surgery, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Klink', 'Affiliation': 'Faculty of Engineering, Institute of Experimental Mechanics, Leipzig University of Applied Sciences, Leipzig, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Slowik', 'Affiliation': 'Faculty of Civil Engineering, Institute of Experimental Mechanics, Leipzig University of Applied Sciences, Leipzig, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Stich', 'Affiliation': 'Department of Chemistry, Leipzig University of Applied Sciences, Leipzig, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Pediatric Surgery, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Engel', 'Affiliation': 'Institute for Medical Informatics, Statistics and Epidemiology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lacher', 'Affiliation': 'Department of Pediatric Surgery, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Boehm', 'Affiliation': 'Department of Pediatric Surgery, University Hospital Leipzig, Leipzig, Germany.'}]",The bone & joint journal,['10.1302/0301-620X.102B10.BJJ-2020-0236.R3']
1925,32993338,Addition of corticosteroid to periarticular injections reduces postoperative pain following total hip arthroplasty under general anaesthesia: a double-blind randomized controlled trial.,"AIMS


Although periarticular injection plays an important role in multimodal pain management following total hip arthroplasty (THA), there is no consensus on the optimal composition of the injection. In particular, it is not clear whether the addition of a corticosteroid improves the pain relief achieved nor whether it is associated with more complications than are observed without corticosteroid. The aim of this study was to quantify the safety and effectiveness of cortocosteroid use in periarticular injection during THA.
METHODS


We conducted a prospective, two-arm, parallel-group, randomized controlled trial involving patients scheduled for unilateral THA. A total of 187 patients were randomly assigned to receive periarticular injection containing either a corticosteroid (CS group) or without corticosteroid (no-CS group). Other perioperative interventions were identical for all patients. The primary outcome was postoperative pain at rest during the initial 24 hours after surgery. Pain score was recorded every three hours until 24 hours using a 100 mm visual analogue scale (VAS). The primary outcome was assessed based on the area under the curve (AUC).
RESULTS


The CS group had a significantly lower AUC postoperatively at 0 to 24 hours compared to the no-CS group (AUC of VAS score at rest 550 ± 362 vs 392 ± 320, respectively; mean difference 158 mm; 95% confidence interval (CI) 58 to 257; p = 0.0021). In point-by-point evaluation, the CS group had significantly lower VAS scores at 12, 15, 18, 21, 24, and 48 hours. There were no significant differences in complication rates, including surgical site infection, between the two groups.
CONCLUSION


The addition of corticosteroid to periarticular injections reduces postoperative pain without increasing complication rate following THA. Cite this article:  Bone Joint J  2020;102-B(10):1297-1302.",2020,"There were no significant differences in complication rates, including surgical site infection, between the two groups.
","['A total of 187 patients', 'patients scheduled for unilateral THA', 'total hip arthroplasty under general anaesthesia', 'total hip arthroplasty (THA']","['corticosteroid to periarticular injections', 'periarticular injection containing either a corticosteroid (CS group) or without corticosteroid']","['postoperative pain at rest', 'complication rates, including surgical site infection', 'VAS scores', 'area under the curve (AUC', 'pain relief', 'safety and effectiveness', 'Pain score', 'postoperative pain']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",187.0,0.57545,"There were no significant differences in complication rates, including surgical site infection, between the two groups.
","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kurosaka', 'Affiliation': 'Department of Orthopaedic Surgery, Hokusuikai Kinen Hospital, Mito, Japan.'}, {'ForeName': 'Sachiyuki', 'Initials': 'S', 'LastName': 'Tsukada', 'Affiliation': 'Department of Orthopaedic Surgery, Hokusuikai Kinen Hospital, Mito, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': 'Department of Orthopaedic Surgery, Hokusuikai Kinen Hospital, Mito, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nishino', 'Affiliation': 'Department of Orthopaedic Surgery, Hokusuikai Kinen Hospital, Mito, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Nakayama', 'Affiliation': 'Department of Rehabilitation, Hokusuikai Kinen Hospital, Mito, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Yoshiya', 'Affiliation': 'Department of Orthopaedic Surgery, Nishinomiya Kaisei Hospital, Hyogo, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Hirasawa', 'Affiliation': 'Department of Orthopaedic Surgery, Hokusuikai Kinen Hospital, Mito, Japan.'}]",The bone & joint journal,['10.1302/0301-620X.102B10.BJJ-2020-0428.R1']
1926,32916250,Impact of dedicated infectious disease teamwork on the treatment and prognosis of patients with diabetic foot infection.,"OBJECTIVE


The aim was to develop and evaluate the impact of a new model in which the infectious disease (ID) physician and pharmacist work together to treat diabetic foot infections (DFIs).
METHODS


A quasi-experimental before-after study was conducted. The medical charts of inpatients with DFI admitted between April 1, 2017 and March 31, 2018 were reviewed retrospectively (control group, n = 30). Inpatients diagnosed with DFI between April 1, 2018 and March 31, 2019 were enrolled prospectively as the intervention group and received treatment through dedicated ID teamwork (intervention group, n = 35).
RESULTS


The distribution of infection severity and levels of metabolic criteria were similar in the two groups. Compared with the control group, the intervention group received adequate initial empirical treatment more frequently (96.8% vs 43.5%, p < 0.001) and had a shorter median duration of fever (1 day vs 7.5 days, p < 0.001). Rates of healing and relapse within 6 months were similar in the two groups, although the intervention group showed more sites of osteomyelitis (p = 0.036) and a higher percentage of polymicrobial infections (48.6% vs 10.0%, p = 0.001).
CONCLUSION


The early and full participation of ID physicians and pharmacists in the treatment of DFI facilitated targeted antimicrobial treatment and improved patient outcomes.",2020,"Rates of healing and relapse within 6 months were similar in the two groups, although the intervention group showed more sites of osteomyelitis (p = 0.036) and a higher percentage of polymicrobial infections (48.6% vs 10.0%, p = 0.001).
","['inpatients with DFI admitted between April 1, 2017 and March 31, 2018 were reviewed retrospectively (control group, n = 30', 'patients with diabetic foot infection', 'Inpatients diagnosed with DFI between April 1, 2018 and March 31, 2019 were enrolled prospectively as the intervention group and received treatment through dedicated ID teamwork (intervention group, n = 35']",['dedicated infectious disease teamwork'],"['Rates of healing and relapse', 'sites of osteomyelitis', 'distribution of infection severity and levels of metabolic criteria', 'polymicrobial infections', 'shorter median duration of fever']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0744130', 'cui_str': 'Diabetic foot infection'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0029443', 'cui_str': 'Osteomyelitis'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0517627', 'cui_str': 'Infection status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",,0.0350705,"Rates of healing and relapse within 6 months were similar in the two groups, although the intervention group showed more sites of osteomyelitis (p = 0.036) and a higher percentage of polymicrobial infections (48.6% vs 10.0%, p = 0.001).
","[{'ForeName': 'Xiang-Yan', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Department of Anti-infection, Institute of Clinical Pharmacology, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: lixyan03598@pkufh.com.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: 04983@pkufh.com.'}, {'ForeName': 'Shuo-Han', 'Initials': 'SH', 'LastName': 'Tian', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: tianshuohan@126.com.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'He', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: doctorherui@163.com.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: jiangshan_beijing@163.com.'}, {'ForeName': 'Hui-Juan', 'Initials': 'HJ', 'LastName': 'Li', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: lihuijuan2010@126.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.08.085']
1927,33002644,Bilateral nucleus basalis of Meynert deep brain stimulation for dementia with Lewy bodies: A randomised clinical trial.,,2020,,['Dementia with Lewy Bodies'],['Bilateral Nucleus Basalis of Meynert D Brain Stimulation'],[],"[{'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}]",[],,0.259573,,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, No.70, Heping Road, Weihai, Shandong, China, 264200. Electronic address: liuwei881x@outlook.com.'}, {'ForeName': 'Dong-Yan', 'Initials': 'DY', 'LastName': 'Yu', 'Affiliation': 'Weihai Municipal Third Hospital, Weihai, Shandong, China, 264205. Electronic address: yudongyan@outlook.com.'}]",Brain stimulation,['10.1016/j.brs.2020.09.020']
1928,33002645,Enhancing cognitive training effects in Alzheimer's disease: rTMS as an add-on treatment.,"The treatment of Alzheimer's disease (AD) in the field of non-pharmacological interventions is a challenging issue, given the limited benefits of the available drugs. Cognitive training (CT) represents a commonly recommended strategy in AD. Recently, repetitive transcranial magnetic stimulation (rTMS) has gained increasing attention as a promising therapeutic tool for the treatment of AD, given its ability of enhancing neuroplasticity. In the present randomized, double-blind, sham-controlled study, we aimed at investigating the add-on effect of a high frequency rTMS protocol applied over the left dorsolateral prefrontal cortex (DLPFC) combined with a face-name associative memory CT in the continuum of AD pathology. Fifty patients from a very early to a moderate phase of dementia were randomly assigned to one of two groups: CT plus real rTMS or CT plus placebo rTMS. The results showed that the improvement in the trained associative memory induced with rTMS was superior to that obtained with CT alone. Interestingly, the extent of the additional improvement was affected by disease severity and levels of education, with less impaired and more educated patients showing a greater benefit. When testing for generalization to non-trained cognitive functions, results indicated that patients in CT-real group showed also a greater improvement in visuospatial reasoning than those in the CT-sham group. Interestingly, this improvement persisted over 12 weeks after treatment beginning. The present study provides important hints on the promising therapeutic use of rTMS in AD.",2020,The results showed that the improvement in the trained associative memory induced with rTMS was superior to that obtained with CT alone.,"['Fifty patients from a very early to a moderate phase of dementia', ""Alzheimer's disease""]","['rTMS', 'CT plus real rTMS or CT plus placebo rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'Cognitive training (CT']","['visuospatial reasoning', 'disease severity and levels of education', 'trained associative memory']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",50.0,0.0608235,The results showed that the improvement in the trained associative memory induced with rTMS was superior to that obtained with CT alone.,"[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Bagattini', 'Affiliation': 'Cognitive Neuroscience Section, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy. Electronic address: chiara.bagattini@cognitiveneuroscience.it.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Zanni', 'Affiliation': ""Fondazione Europea Ricerca Biomedica, Ospedale Sant'Isidoro, 24069, Trescore Balneario, Bergamo, Italy.""}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Barocco', 'Affiliation': ""Fondazione Europea Ricerca Biomedica, Ospedale Sant'Isidoro, 24069, Trescore Balneario, Bergamo, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Caffarra', 'Affiliation': 'Department of Medicine and Surgery, Section of Neuroscience, University of Parma, 43126, Parma, Italy.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Brignani', 'Affiliation': 'Cognitive Neuroscience Section, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Miniussi', 'Affiliation': 'Center for Mind/Brain Sciences- CIMeC, University of Trento, 38068, Rovereto, Italy.'}, {'ForeName': 'Carlo Alberto', 'Initials': 'CA', 'LastName': 'Defanti', 'Affiliation': ""Fondazione Europea Ricerca Biomedica, Ospedale Sant'Isidoro, 24069, Trescore Balneario, Bergamo, Italy.""}]",Brain stimulation,['10.1016/j.brs.2020.09.010']
1929,33002684,Positive memory training for the treatment of depression in schizophrenia: A randomised controlled trial.,"BACKGROUND


Around half of people diagnosed with schizophrenia suffer from co-morbid depression, yet there are no evidence-based psychological treatments to target this presentation.
METHOD


Participants were aged 18-65 years old, had a clinical diagnosis of schizophrenia or schizoaffective disorder and at least a mild level of depression. Participants were randomly assigned (1:1) to receive PoMeT or treatment as usual. PoMeT was delivered in up to 12 individual sessions within 3 months. We stratified randomisation by site and by severity of depression using randomised-permuted blocks. Assessments were carried out at baseline, 3-month, 6-month and 9-month by assessors who were blind to treatment allocation. The primary outcome was reduction in the symptoms of depression at 3-month, 6-month and 9-month as measured by the BDI-II. Analysis was by intention-to-treat with linear mixed-effects models. The trial was registered with the ISRCTN registry number 99485756.
RESULTS


One hundred participants were randomly assigned to either PoMeT (n = 49) or treatment as usual (n = 51). The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03).
DISCUSSION


To our knowledge this is, to date, the largest powered randomised controlled trial focused on the psychological treatment of depression in people diagnosed with schizophrenia. Results indicate that a brief targeted intervention can reduce the symptoms of depression in the group. The main limitation of the study is the lack of an active control group which may contribute to an inflated treatment effect.",2020,"The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03).
","['people diagnosed with schizophrenia', 'One hundred participants', 'Participants were aged 18-65 years old, had a clinical diagnosis of schizophrenia or schizoaffective disorder and at least a mild level of depression', 'depression in schizophrenia']","['PoMeT', 'Positive memory training']","['symptoms of depression', 'symptoms of depression at 3-month, 6-month and 9-month as measured by the BDI-II', 'reduction in BDI-II total score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0561841', 'cui_str': 'Pleasant memories'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.285473,"The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03).
","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Steel', 'Affiliation': 'Oxford Health NHS Foundation Trust, Oxford, UK; School of Psychology, University of Reading, UK. Electronic address: craig.steel@hmc.ox.ac.uk.'}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'Korrelboom', 'Affiliation': 'Department of Anxiety Disorders, PsyQ Parnassia Group, Psychiatric Center, The Hague, the Netherlands; Department of Medical and Clinical Psychiatry, Tilburg University, Tilburg, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fazil Baksh', 'Affiliation': 'Department of Mathematics and Statistics, University of Reading, Whiteknights, Reading, RG6 6AL, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kingdon', 'Affiliation': 'University of Southampton, Highfield, Southampton, SO17 1BJ, UK.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Simon', 'Affiliation': 'Department of Health Economics, Center for Public Health, Medical University of Vienna, 1090, Wien, Kinderspitalgasse 15, Austria; Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford OX3 7JX, UK.'}, {'ForeName': 'Til', 'Initials': 'T', 'LastName': 'Wykes', 'Affiliation': 'Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Phiri', 'Affiliation': 'Southern Health NHS Foundation Trust, Research & Development Department, Tom Rudd Unit, Moorgreen Hospital, Botley Rd, West End Southampton, SO30 3JB, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van der Gaag', 'Affiliation': 'VU University and Amsterdam Public Mental Health Research Institute, Department of Clinical Psychology Van der Boechorststraat 1, 1081, BT, Amsterdam, the Netherlands; Parnassia Psychiatric Institute, Zoutkeetsingel 40, 2512, HN, The Hague, the Netherlands.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103734']
1930,33002685,Collaborative care for depression in older adults: How much is enough?,"Collaborative care in primary care has been shown to be effective for subthreshold depression in older adults in the 'CASPER' trial. However, to understand the impact of adherence, and to explore the minimum effective dose of collaborative care, we reanalysed the trial data using a complier average causal effect (CACE) analysis. Data were available for 705 participants, 519 with 12-month PHQ-9 scores. 'Compliance' could be observed for participants in the intervention group. Latent complier status in the control group was estimated. Completion of five or more sessions of care was defined as 'compliance'. Sensitivity analyses, using alternative cut-offs of two to eight sessions, assessed the impact of changing the definition of 'compliance'. Compliers in the intervention group had lower PHQ-9 scores at 12-month follow up than assumed compliers in the control group (1.75 lower, 95% confidence interval 0.29 to 3.21, p = 0.02), a greater effect than originally reported. Sensitivity analyses confirmed statistically significant differences between the intervention and control groups in those attending five or more sessions. We conclude that collaborative care is causally effective in reducing subthreshold depressive symptoms in older people who adhere to treatment. Our findings suggest the minimum effective dose is five sessions.",2020,"Compliers in the intervention group had lower PHQ-9 scores at 12-month follow up than assumed compliers in the control group (1.75 lower, 95% confidence interval 0.29 to 3.21, p = 0.02), a greater effect than originally reported.","['older adults', '705 participants, 519 with 12-month PHQ-9 scores. ', 'older people who adhere to treatment']","['collaborative care', 'Collaborative care']","['lower PHQ-9 scores', 'subthreshold depressive symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",705.0,0.060507,"Compliers in the intervention group had lower PHQ-9 scores at 12-month follow up than assumed compliers in the control group (1.75 lower, 95% confidence interval 0.29 to 3.21, p = 0.02), a greater effect than originally reported.","[{'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Bonvoisin', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull University Teaching Hospitals NHS Trust, Hull, HU3 2JZ, UK. Electronic address: ttb508@york.ac.uk.'}, {'ForeName': 'Lewis W', 'Initials': 'LW', 'LastName': 'Paton', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK. Electronic address: lewis.paton@york.ac.uk.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK. Electronic address: catherine.hewitt@york.ac.uk.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'McMillan', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull York Medical School, University of York, Heslington, YO10 5DD, UK. Electronic address: dean.mcmillan@york.ac.uk.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull York Medical School, University of York, Heslington, YO10 5DD, UK. Electronic address: simon.gilbody@york.ac.uk.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Tiffin', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull York Medical School, University of York, Heslington, YO10 5DD, UK. Electronic address: paul.tiffin@york.ac.uk.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103725']
1931,33009690,Outcomes of monthly video consultations as an add-on to regular care for children with type 1 diabetes: A 6-month quasi-randomized clinical trial followed by an extension phase.,"OBJECTIVE


To explore the outcomes of monthly video consultations for children with diabetes.
METHODS


The Virtual Outpatient Diabetes Clinic for Children and Youth (VIDIKI) was a 6-month multicenter controlled clinical trial followed by an extension phase. The 240 participants (1-16 years), all using a CGM, were quasi-randomized by residence location to the intervention group (IG) or the waitlist-control group (WG). The IG started immediately after enrollment with monthly video consultations as an add-on to regular care, while the WG received regular care for 6 months before starting the intervention. The extension phase lasted between 12 months and 2 years, depending on the enrollment date. Linear regression was applied to model the primary outcome of HbA1c after 6 months and other metabolic and psychosocial outcomes.
RESULTS


After covariate adjustments, the HbA1c at 6 months-corresponding to the controlled treatment phase-was 0.11% lower in the IG than that in the WG (95% CI -0.31 to 0.09, P = .277). For the total study sample, a significant HbA1c improvement was found after 12 months of video consultations, which increased further until month 15. The diabetes burden of the main caregivers was lower, and parental treatment satisfaction was significantly higher in the IG than that in the WG.
CONCLUSIONS


The VIDIKI study found no significant HbA1c difference between IG and WG after 6 months in the controlled phase, but there was a decreased diabetes burden and increased treatment satisfaction for the parents. In the longitudinal perspective, a significant HbA1c improvement was found after 12 and 15 months.",2020,"The diabetes burden of the main caregivers was lower, and parental treatment satisfaction was significantly higher in the IG than that in the WG.
","['children with diabetes', 'children with type 1 diabetes', '240 participants (1-16\u2009years), all using a CGM, were quasi-randomized by residence location to the intervention group (IG) or the', 'Virtual Outpatient Diabetes Clinic for Children and Youth (VIDIKI']",['waitlist-control group (WG'],"['diabetes burden and increased treatment satisfaction', 'parental treatment satisfaction']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",240.0,0.04624,"The diabetes burden of the main caregivers was lower, and parental treatment satisfaction was significantly higher in the IG than that in the WG.
","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'von Sengbusch', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetology, University Medical Center Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Eisemann', 'Affiliation': 'Institute for Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Mueller-Godeffroy', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetology, University Medical Center Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Hannover Medical School, Medical Psychology, Hannover, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Doerdelmann', 'Affiliation': 'Institute for Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Alev', 'Initials': 'A', 'LastName': 'Erdem', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetology, University Medical Center Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Menrath', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetology, University Medical Center Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Bokelmann', 'Affiliation': 'Department of Pediatrics Kiel, University Medical Centre Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Krasmann', 'Affiliation': 'Department of Pediatrics Kiel, University Medical Centre Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Kaczmarczyk', 'Affiliation': 'Department of Pediatrics, General Hospital Kiel, Kiel, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Bertram', 'Affiliation': 'Department of Pediatrics, General Hospital Kiel, Kiel, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Hiort', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetology, University Medical Center Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Katalinic', 'Affiliation': 'Institute for Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Fabian S', 'Initials': 'FS', 'LastName': 'Frielitz', 'Affiliation': 'Institute for Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany.'}]",Pediatric diabetes,['10.1111/pedi.13133']
1932,33010242,"Safety and immunogenicity of two heterologous HIV vaccine regimens in healthy, HIV-uninfected adults (TRAVERSE): a randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study.","BACKGROUND


Bioinformatically designed mosaic antigens increase the breadth of HIV vaccine-elicited immunity. This study compared the safety, tolerability, and immunogenicity of a newly developed, tetravalent Ad26 vaccine with the previously tested trivalent formulation.
METHODS


This randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study (TRAVERSE) was done at 11 centres in the USA and one centre in Rwanda. Eligible participants were adults aged 18 to 50 years, who were HIV-uninfected, healthy at screening based on their medical history and a physical examination including laboratory assessment and vital sign measurements, and at low risk of HIV infection in the opinion of study staff, who applied a uniform definition of low-risk guidelines that was aligned across sites. Enrolled participants were randomly assigned at a 2:1 ratio to tetravalent and trivalent groups. Participants in tetravalent and trivalent groups were then further randomly assigned at a 5:1 ratio to adenovirus 26 (Ad26)-vectored vaccine and placebo subgroups. Randomisation was stratified by region (USA and Rwanda) and based on a computer-generated schedule using randomly permuted blocks prepared under the sponsor's supervision. We masked participants and investigators to treatment allocation throughout the study. On day 0, participants received a first injection of tetravalent vaccine (Ad26.Mos4.HIV or placebo) or trivalent vaccine (Ad26.Mos.HIV or placebo), and those injections were repeated 12 weeks later. At week 24, vaccine groups received a third dose of tetravalent or trivalent together with clade C gp140, and this was repeated at week 48, with placebos again administered to the placebo group. All study vaccines and placebo were administered by intramuscular injection in the deltoid muscle. We assessed adverse events in all participants who received at least one study injection (full analysis set) and Env-specific binding antibodies in all participants who received at least the first three vaccinations according to the protocol-specified vaccination schedule, had at least one measured post-dose blood sample collected, and were not diagnosed with HIV during the study (per-protocol set). This study is registered with Clinicaltrials.gov, NCT02788045.
FINDINGS


Of 201 participants who were enrolled and randomly assigned, 198 received the first vaccination: 110 were in the tetravalent group, 55 in the trivalent group, and 33 in the placebo group. Overall, 185 (93%) completed two scheduled vaccinations per protocol, 180 (91%) completed three, and 164 (83%) completed four. Solicited, self-limiting local, systemic reactogenicity and unsolicited adverse events were similar in vaccine groups and higher than in placebo groups. All participants in the per-protocol set developed clade C Env binding antibodies after the second vaccination, with higher total IgG titres after the tetravalent vaccine than after the trivalent vaccine (10 413 EU/mL, 95% CI 7284-14 886 in the tetravalent group compared with 5494 EU/mL, 3759-8029 in the trivalent group). Titres further increased after the third and fourth vaccinations, persisting at least through week 72. Other immune responses were also higher with the tetravalent vaccine, including the magnitude and breadth of binding antibodies against a cross-clade panel of Env antigens, and the magnitude of IFNγ ELISPOT responses (median 521 SFU/10 6  peripheral blood mononuclear cells [PBMCs] in the tetravalent group and median 282 SFU/10 6  PBMCs in the trivalent group after the fourth vaccination) and Env-specific CD4+ T-cell response rates after the third and fourth vaccinations. No interference by pre-existing Ad26 immunity was identified.
INTERPRETATION


The tetravalent vaccine regimen was generally safe, well-tolerated, and found to elicit higher immune responses than the trivalent regimen. Regimens that use this tetravalent vaccine component are being advanced into field trials to assess efficacy against HIV-1 infection.
FUNDING


National Institutes of Health, Henry M Jackson Foundation for Advancement of Military Medicine and the US Department of Defense, Ragon Institute of MGH, MIT, & Harvard, Bill & Melinda Gates Foundation, and Janssen Vaccines & Prevention.",2020,"Solicited, self-limiting local, systemic reactogenicity and unsolicited adverse events were similar in vaccine groups and higher than in placebo groups.","['Eligible participants were adults aged 18 to 50 years, who were HIV-uninfected, healthy at screening based on their medical history and a physical examination including laboratory assessment and vital sign measurements, and at low risk of HIV infection in the opinion of study staff, who applied a uniform definition of low-risk guidelines that was aligned across sites', '11 centres in the USA and one centre in Rwanda', 'healthy, HIV-uninfected adults (TRAVERSE', '201 participants who were enrolled and randomly assigned']","['HIV or placebo', 'tetravalent vaccine (Ad26.Mos4.HIV or placebo) or trivalent vaccine (Ad26.Mos', 'heterologous HIV vaccine regimens', 'placebos again administered to the placebo', 'placebo', 'adenovirus 26 (Ad26)-vectored vaccine and placebo']","['clade C Env binding antibodies', 'total IgG titres', 'Solicited, self-limiting local, systemic reactogenicity and unsolicited adverse events', 'Safety and immunogenicity', 'adverse events', 'IFNγ ELISPOT responses', 'safety, tolerability, and immunogenicity', 'Env-specific CD4+ T-cell response rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0439860', 'cui_str': 'Heterologous'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}]","[{'cui': 'C0017343', 'cui_str': 'ENV gene'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0920508', 'cui_str': 'Enzyme linked immunospot assay'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",,0.625106,"Solicited, self-limiting local, systemic reactogenicity and unsolicited adverse events were similar in vaccine groups and higher than in placebo groups.","[{'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Baden', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: lbaden@bwh.harvard.edu.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Stieh', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Sarnecki', 'Affiliation': 'Janssen Vaccines, Bern, Switzerland.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Alter', 'Affiliation': 'Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Ferrari', 'Affiliation': 'Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Montefiori', 'Affiliation': 'Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Mann', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Nijs', 'Affiliation': 'Janssen Infectious Diseases, Beerse, Belgium.'}, {'ForeName': 'Katleen', 'Initials': 'K', 'LastName': 'Callewaert', 'Affiliation': 'Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Goepfert', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Srilatha', 'Initials': 'S', 'LastName': 'Edupuganti', 'Affiliation': 'Hope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Karita', 'Affiliation': 'Rwanda Zambia HIV Research Group, Kigali, Rwanda.'}, {'ForeName': 'Johannes P', 'Initials': 'JP', 'LastName': 'Langedijk', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wegmann', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Pau', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tomaka', 'Affiliation': 'Janssen Research and Development, Titusville, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30229-0']
1933,33011163,Does Dynamic Intermaxillary Fixation With Elastics Improve Outcomes Following Unilateral Condylar Fracture?,"PURPOSE


The use of rigid versus semi-rigid intermaxillary fixation (IMF) following subcondylar fractures is controversial. This study aims to investigate whether the ""dynamic"" elastic fixation technique improves the outcomes, compared to the rigid fixation technique for the treatment of displaced subcondylar fractures in adults.
MATERIALS AND METHODS


This nonblinded randomized clinical trial was performed on adult patients with unilateral displaced mandibular subcondylar fractures. Patients were randomly allocated into two groups (n = 17). The primary predictor variable was wire versus elastic IMF. Changes in primary (mouth opening) and secondary (other clinical and radiological) outcomes were recorded. Data were analyzed with the t test and Mann-Whitney test with SPSS software version 20. P-value < .05 considered as significant.
RESULTS


In this study 34 patients (with mean age of 33.03 ± 1.79, 23.5% females & 76.5% males) in two groups (Elastics & Wire) followed up to 6 months. The Elastics group showed significant improvement in mouth opening (primary outcome) after 1 month of follow-up, but the differences were not significant at the end of the study. In terms of secondary outcomes, the ramus height shortening compared to the opposite side revealed favorable improvement in the Elastics group in the period of study. The differences between the two groups in the lateral movement and protrusive movement were significant in favor of the Elastics group. The differences in pain, fracture displacement, and midline deviation between study groups were not significant at the end of the study. Just 1 case with malocclusion was observed in the Wire group. Patients were more satisfied with dynamic nonrigid IMF with elastics.
CONCLUSIONS


The results of this study showed that using the dynamic IMF technique is more tolerable, and patients have better functional and clinical outcomes during and at the end treatment.",2020,The differences between the two groups in the lateral movement and protrusive movement were significant in favor of the Elastics group.,"['displaced subcondylar fractures in adults', '34 patients (with mean age of 33.03\xa0±\xa01.79, 23.5% females & 76.5% males) in two groups (Elastics & Wire) followed up to 6\xa0months', 'adult patients with unilateral displaced mandibular subcondylar fractures']","['dynamic"" elastic fixation technique', 'rigid fixation technique', 'dynamic IMF technique', 'rigid versus semi-rigid intermaxillary fixation (IMF']","['mouth opening', 'pain, fracture displacement, and midline deviation', 'ramus height shortening', 'lateral movement and protrusive movement', 'wire versus elastic IMF']","[{'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}]","[{'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0585059', 'cui_str': 'Fracture with displacement'}, {'cui': 'C0399532', 'cui_str': 'Midline deviation of dental arch'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",34.0,0.0216468,The differences between the two groups in the lateral movement and protrusive movement were significant in favor of the Elastics group.,"[{'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Khiabani', 'Affiliation': 'Associate professor, Department of Oral & Maxillofacial surgery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Zinhaghayegh', 'Affiliation': 'Assistant professor, Department of oral and maxillofacial surgery, Tabriz branch Islamic Azad University, Tabriz, Iran.'}, {'ForeName': 'Mohammad Hosein', 'Initials': 'MH', 'LastName': 'Amirzade-Iranaq', 'Affiliation': 'Researcher, Universal Network of Interdisciplinary Research in Oral and Maxillofacial Surgery (UNIROMS), Universal Scientific Education and Research Network (USERN), Tehran, Iran; Department head, Department of Research, Arka Education and Clinical Research Consultants, Tehran, Iran. Electronic address: h.amirzade@gmail.com.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.08.040']
1934,33012155,Short-course versus long-course neoadjuvant chemoradiotherapy in patients with rectal cancer: preliminary results of a randomized controlled trial.,"PURPOSE


Colorectal cancer is becoming an increasing concern in the middle-aged population of Iran. This study aimed to compare the preliminary results of short-course and long-course neoadjuvant chemoradiotherapy treatment for rectal cancer patients.
MATERIALS AND METHODS


Patients in group I received three-dimensional conformational radiotherapy with a dose of 25 Gy/5 fractions in 1 week plus concurrent XELOX regimen (capecitabine 625 mg/m2 from day 1-5 twice daily and oxaliplatin 50 mg/m2 on day 1 once daily). Patients in group II received a total dose of 50-50.4 Gy/25-28 fractions for 5 to 5.5 weeks plus capecitabine 825 mg/m2 twice daily. Both groups underwent delayed surgery at least 8 weeks after radiotherapy completion. The pathological response was assessed with tumor regression grade.
RESULTS


In this preliminary report on complications and pathological response, 66 patients were randomized into study groups. Mean duration of radiotherapy in the two groups was 5 ± 1 days (range, 5 to 8 days) and 38 ± 6 days (range, 30 to 58 days). The median follow-up was 18 months. Pathological complete response was achieved in 32.3% and 23.1% of patients in the short-course and long-course groups, respectively (p = 0.558). Overall, acute grade 3 or higher treatment-related toxicities occurred in 24.2% and 22.2% of patients in group I and II, respectively (p = 0.551). No acute grade 4 or 5 adverse events were observed in either group. Within one month of surgery, no significant difference was seen regarding grade ≥3 postoperative complications (p = 0.333).
CONCLUSION


For patients with rectal cancer located 5 cm above the anal verge, short-course radiotherapy with concurrent and consolidation chemotherapy and delayed surgery is not different in terms of acute toxicity, postoperative morbidity, complete resection, and pathological response compared to long-course chemoradiotherapy.",2020,"Within one month of surgery, no significant difference was seen regarding grade ≥3 postoperative complications (p = 0.333).
","['66 patients', 'patients with rectal cancer', 'Patients in group I received', 'rectal cancer patients', 'middle-aged population of Iran']","['short-course and long-course neoadjuvant chemoradiotherapy treatment', 'capecitabine', 'Short-course versus long-course neoadjuvant chemoradiotherapy', 'XELOX regimen (capecitabine 625 mg/m2 from day 1-5 twice daily and oxaliplatin', 'three-dimensional conformational radiotherapy']","['Mean duration of radiotherapy', 'Pathological complete response', 'Overall, acute grade 3 or higher treatment-related toxicities', 'acute grade 4 or 5 adverse events', 'acute toxicity, postoperative morbidity, complete resection, and pathological response', 'grade ≥3 postoperative complications', 'pathological response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C4517838', 'cui_str': '625'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",66.0,0.0854031,"Within one month of surgery, no significant difference was seen regarding grade ≥3 postoperative complications (p = 0.333).
","[{'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Aghili', 'Affiliation': 'Radiation Oncology Research Center, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Khalili', 'Affiliation': 'School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Khalili', 'Affiliation': 'School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Babaei', 'Affiliation': 'Radiation Oncology Research Center, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farshid', 'Initials': 'F', 'LastName': 'Farhan', 'Affiliation': 'Radiation Oncology Research Center, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Peiman', 'Initials': 'P', 'LastName': 'Haddad', 'Affiliation': 'Radiation Oncology Research Center, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Salarvand', 'Affiliation': 'Department of Anatomical and Clinical Pathology, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Keshvari', 'Affiliation': 'Colorectal Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Fazeli', 'Affiliation': 'Colorectal Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Mohammadi', 'Affiliation': 'Radiation Oncology Research Center, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Ghalehtaki', 'Affiliation': 'Radiation Oncology Research Center, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.'}]",Radiation oncology journal,['10.3857/roj.2020.00115']
1935,32993607,"Safety and Health through Integrated, Facilitated Teams (SHIFT): stepped-wedge protocol for prospective, mixed-methods evaluation of the Healthy Workplace Participatory Program.","BACKGROUND


Healthcare facilities are notorious for occupational health and safety problems. Multi-level interventions are needed to address interacting exposures and their overlapping origins in work organization features. Worker participation in problem identification and resolution is essential. This study evaluates the CPH-NEW Healthy Workplace Participatory Program (HWPP), a Total Worker Health® protocol to develop effective employee teams for worker safety, health, and wellbeing.
METHODS


Six public sector, unionized healthcare facilities are enrolled, in three pairs, matched by agency. The unit of intervention is a workplace health and safety committee, adapted here to a joint labor-management ""Design Team"" (DT). The DT conducts root cause analyses, prioritizes problems, identifies feasible interventions in light of the constraints and needs of the specific setting, makes business-case presentations to facility leadership, and assists in evaluation. Following a stepped-wedge (cross-over) design, one site in each pair is randomly assigned to ""immediate intervention"" status, receiving the full coached intervention at baseline; in the ""lagged intervention"" site, coaching begins about half-way through the study. Program effectiveness and cost-effectiveness outcomes are assessed at both organizational (e.g., workers' compensation claim and absenteeism rates, perceived management support of safety) and individual levels (e.g., self-rated health, sleep quality, leisure-time exercise). Targeted pre-post analyses will also examine specific outcomes appropriate to the topics selected for intervention. Process evaluation outcomes include fidelity of the HWPP intervention, extent of individual DT member activity, expansion of committee scope to include employee well-being, program obstacles and opportunities in each setting, and sustainability (within the available time frame).
DISCUSSION


This study aims for a quantitative evaluation of the HWPP over a time period long enough to accomplish multiple intervention cycles in each facility. The design seeks to achieve comparable study engagement and data quality between groups. We will also assess whether the HWPP might be further improved to meet the needs of U.S. public sector healthcare institutions. Potential challenges include difficulty in pooling data across study sites if Design Teams select different intervention topics, and follow-up periods too short for change to be observed.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04251429 (retrospectively registered January 29, 2020), protocol version 1.",2020,"This study evaluates the CPH-NEW Healthy Workplace Participatory Program (HWPP), a Total Worker Health® protocol to develop effective employee teams for worker safety, health, and wellbeing.
",['Six public sector'],"['HWPP', 'CPH-NEW Healthy Workplace Participatory Program (HWPP']","['Program effectiveness and cost-effectiveness outcomes', 'fidelity of the HWPP intervention, extent of individual DT member activity, expansion of committee scope to include employee well-being, program obstacles and opportunities in each setting, and sustainability (within the available time frame', ""organizational (e.g., workers' compensation claim and absenteeism rates, perceived management support of safety) and individual levels (e.g., self-rated health, sleep quality, leisure-time exercise""]","[{'cui': 'C0034035', 'cui_str': 'Public Sector'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0054757', 'cui_str': 'Carboxypeptidase H'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0033334', 'cui_str': 'Program Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332168', 'cui_str': 'Time frame'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C0043233', 'cui_str': ""Worker's Compensation""}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0398009,"This study evaluates the CPH-NEW Healthy Workplace Participatory Program (HWPP), a Total Worker Health® protocol to develop effective employee teams for worker safety, health, and wellbeing.
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Punnett', 'Affiliation': 'Center for the Promotion of Health in the New England Workplace (CPH-NEW), Lowell, MA, USA. Laura_Punnett@uml.edu.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Nobrega', 'Affiliation': 'Center for the Promotion of Health in the New England Workplace (CPH-NEW), Lowell, MA, USA.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Center for the Promotion of Health in the New England Workplace (CPH-NEW), Lowell, MA, USA.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Rice', 'Affiliation': 'Center for the Promotion of Health in the New England Workplace (CPH-NEW), Lowell, MA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gore', 'Affiliation': 'Center for the Promotion of Health in the New England Workplace (CPH-NEW), Lowell, MA, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Kurowski', 'Affiliation': 'Center for the Promotion of Health in the New England Workplace (CPH-NEW), Lowell, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC public health,['10.1186/s12889-020-09551-2']
1936,32993779,Personalised health education against health damage of COVID-19 epidemic in the elderly Hungarian population (PROACTIVE-19): protocol of an adaptive randomised controlled clinical trial.,"BACKGROUND


Early reports indicate that COVID-19 may require intensive care unit (ICU) admission in 5-26% and overall mortality can rise to 11% of the recognised cases, particularly affecting the elderly. There is a lack of evidence-based targeted pharmacological therapy for its prevention and treatment. We aim to compare the effects of a World Health Organization recommendation-based education and a personalised complex preventive lifestyle intervention package (based on the same WHO recommendation) on the outcomes of the COVID-19.
METHODS


PROACTIVE-19 is a pragmatic, randomised controlled clinical trial with adaptive ""sample size re-estimation"" design. Hungarian population over the age of 60 years without confirmed COVID-19 will be approached to participate in a telephone health assessment and lifestyle counselling voluntarily. Volunteers will be randomised into two groups: (A) general health education and (B) personalised health education. Participants will go through questioning and recommendation in 5 fields: (1) mental health, (2) smoking habits, (3) physical activity, (4) dietary habits, and (5) alcohol consumption. Both groups A and B will receive the same line of questioning to assess habits concerning these topics. Assessment will be done weekly during the first month, every second week in the second month, then monthly. The composite primary endpoint will include the rate of ICU admission, hospital admission (longer than 48 h), and mortality in COVID-19-positive cases. The estimated sample size is 3788 subjects per study arm. The planned duration of the follow-up is a minimum of 1 year.
DISCUSSION


These interventions may boost the body's cardiovascular and pulmonary reserve capacities, leading to improved resistance against the damage caused by COVID-19. Consequently, lifestyle changes can reduce the incidence of life-threatening conditions and attenuate the detrimental effects of the pandemic seriously affecting the older population.
TRIAL REGISTRATION


The study has been approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (IV/2428- 2 /2020/EKU) and has been registered at clinicaltrials.gov ( NCT04321928 ) on 25 March 2020.",2020,"The composite primary endpoint will include the rate of ICU admission, hospital admission (longer than 48 h), and mortality in COVID-19-positive cases.","['Hungarian population over the age of 60\u2009years', '3788 subjects per study arm', 'Participants will go through questioning and recommendation in 5 fields: (1) mental health, (2) smoking habits, (3) physical activity, (4) dietary habits, and (5) alcohol consumption', 'elderly Hungarian population']","['general health education and (B) personalised health education', 'Personalised health education', 'World Health Organization recommendation-based education and a personalised complex preventive lifestyle intervention package']","['rate of ICU admission, hospital admission (longer than 48\u2009h), and mortality in COVID-19-positive cases']","[{'cui': 'C0020173', 'cui_str': 'Hungarian language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C4505437', 'cui_str': 'Smoking Habit'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",,0.121932,"The composite primary endpoint will include the rate of ICU admission, hospital admission (longer than 48 h), and mortality in COVID-19-positive cases.","[{'ForeName': 'Bálint', 'Initials': 'B', 'LastName': 'Erőss', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Molnár', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Szakács', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Noémi', 'Initials': 'N', 'LastName': 'Zádori', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Szakó', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Szilárd', 'Initials': 'S', 'LastName': 'Váncsa', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Márk Félix', 'Initials': 'MF', 'LastName': 'Juhász', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Klementina', 'Initials': 'K', 'LastName': 'Ocskay', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Nóra', 'Initials': 'N', 'LastName': 'Vörhendi', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Katalin', 'Initials': 'K', 'LastName': 'Márta', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Szentesi', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Párniczky', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Péter J', 'Initials': 'PJ', 'LastName': 'Hegyi', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Szabolcs', 'Initials': 'S', 'LastName': 'Kiss', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Mária', 'Initials': 'M', 'LastName': 'Földi', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Fanni', 'Initials': 'F', 'LastName': 'Dembrovszky', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kanjo', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Piroska', 'Initials': 'P', 'LastName': 'Pázmány', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Varró', 'Affiliation': 'Department of Pharmacology and Pharmacotherapy, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Árpád', 'Initials': 'Á', 'LastName': 'Csathó', 'Affiliation': 'Department of Behavioral Sciences, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Helyes', 'Affiliation': 'János Szentágothai Research Centre, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Péterfi', 'Affiliation': 'Division of Infectious Diseases, 1st Department of Medicine, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Czopf', 'Affiliation': 'Division of Cardiology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Kiss', 'Affiliation': 'Department of Public Health, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Antal', 'Initials': 'A', 'LastName': 'Zemplényi', 'Affiliation': 'Health Technology Assessment Center, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Dóra', 'Initials': 'D', 'LastName': 'Czapári', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Hegyi', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Dalma', 'Initials': 'D', 'LastName': 'Dobszai', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Emőke', 'Initials': 'E', 'LastName': 'Miklós', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Márta', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Tóth', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Farkas', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Nelli', 'Initials': 'N', 'LastName': 'Farkas', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Birkás', 'Affiliation': 'Department of Behavioral Sciences, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Pintér', 'Affiliation': 'János Szentágothai Research Centre, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Pethő', 'Affiliation': 'János Szentágothai Research Centre, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Borbála', 'Initials': 'B', 'LastName': 'Zsigmond', 'Affiliation': 'Heim Pál National Pediatric Institute, Budapest, Hungary.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Sárközi', 'Affiliation': 'Heim Pál National Pediatric Institute, Budapest, Hungary.'}, {'ForeName': 'Anikó', 'Initials': 'A', 'LastName': 'Nagy', 'Affiliation': 'Heim Pál National Pediatric Institute, Budapest, Hungary.'}, {'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Hegyi', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary. p.hegyi@tm-centre.org.'}]",Trials,['10.1186/s13063-020-04733-0']
1937,32996722,Comparative study of motor cortical excitability changes following anodal tDCS or high-frequency tRNS in relation to stimulation duration.,"BACKGROUND


In this study, we investigate the capacity of two different non-invasive brain stimulation (NIBS) techniques (anodal transcranial direct current stimulation (anodal tDCS) and high-frequency transcranial random noise stimulation (hf-tRNS)) regarding the relationship between stimulation duration and their efficacy in inducing long-lasting changes in motor cortical excitability.
METHODS


Fifteen healthy subjects attended six experimental sessions (90 experiments in total) and underwent both anodal tDCS of 7, 13, and 20 min duration, as well as high-frequency 1mA-tRNS of 7, 13, and 20 min stimulation duration. Sessions were performed in a randomized order and subjects were blinded to the applied methods.
RESULTS


For anodal tDCS, no significant stable increases of motor cortical excitability were observed for either stimulation duration. In contrast, for hf -tRNS a stimulation duration of 7 min resulted in a significant increase of motor cortical excitability lasting from 20 to 60 min poststimulation. While an intermediate duration of 13 min hf-tRNS failed to induce lasting changes in motor cortical excitability, a longer stimulation duration of 20 min hf-tRNS led only to significant increases at 50 min poststimulation which did not outlast until 60 min poststimulation.
CONCLUSION


Hf-tRNS for a duration of 7 min induced robust increases of motor cortical excitability, suggesting an indirect proportional relationship between stimulation duration and efficacy. While hf-tRNS appeared superior to anodal tDCS in this study, further systematic and randomized experiments are necessary to evaluate the generalizability of our observations and to address current intensity as a further modifiable contributor to the variability of transcranial brain stimulation.",2020,"Hf-tRNS for a duration of 7 min induced robust increases of motor cortical excitability, suggesting an indirect proportional relationship between stimulation duration and efficacy.",['Fifteen healthy subjects attended six experimental sessions (90 experiments in total) and underwent both'],"['invasive brain stimulation (NIBS) techniques (anodal transcranial direct current stimulation (anodal tDCS) and high-frequency transcranial random noise stimulation (hf-tRNS', 'anodal tDCS']","['motor cortical excitability lasting', 'motor cortical excitability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}]",15.0,0.0268069,"Hf-tRNS for a duration of 7 min induced robust increases of motor cortical excitability, suggesting an indirect proportional relationship between stimulation duration and efficacy.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Haeckert', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Munich, München, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Lasser', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Munich, München, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Pross', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Munich, München, Germany.'}, {'ForeName': 'Alkomiet', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Munich, München, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Strube', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Munich, München, Germany.'}]",Physiological reports,['10.14814/phy2.14595']
1938,32997907,Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC.,"BACKGROUND


The efficacy and safety of the anti-programmed death ligand 1 (PD-L1) monoclonal antibody atezolizumab, as compared with those of platinum-based chemotherapy, as first-line treatment for patients with metastatic non-small-cell lung cancer (NSCLC) with PD-L1 expression are not known.
METHODS


We conducted a randomized, open-label, phase 3 trial involving patients with metastatic nonsquamous or squamous NSCLC who had not previously received chemotherapy and who had PD-L1 expression on at least 1% of tumor cells or at least 1% of tumor-infiltrating immune cells as assessed by the SP142 immunohistochemical assay. Patients were assigned in a 1:1 ratio to receive atezolizumab or chemotherapy. Overall survival (primary end point) was tested hierarchically according to PD-L1 expression status among patients in the intention-to-treat population whose tumors were wild-type with respect to  EGFR  mutations or  ALK  translocations. Within the population with  EGFR  and  ALK  wild-type tumors, overall survival and progression-free survival were also prospectively assessed in subgroups defined according to findings on two PD-L1 assays as well as by blood-based tumor mutational burden.
RESULTS


Overall, 572 patients were enrolled. In the subgroup of patients with  EGFR  and  ALK  wild-type tumors who had the highest expression of PD-L1 (205 patients), the median overall survival was longer by 7.1 months in the atezolizumab group than in the chemotherapy group (20.2 months vs. 13.1 months; hazard ratio for death, 0.59; P = 0.01). Among all the patients who could be evaluated for safety, adverse events occurred in 90.2% of the patients in the atezolizumab group and in 94.7% of those in the chemotherapy group; grade 3 or 4 adverse events occurred in 30.1% and 52.5% of the patients in the respective groups. Overall and progression-free survival favored atezolizumab in the subgroups with a high blood-based tumor mutational burden.
CONCLUSIONS


Atezolizumab treatment resulted in significantly longer overall survival than platinum-based chemotherapy among patients with NSCLC with high PD-L1 expression, regardless of histologic type. (Funded by F. Hoffmann-La Roche/Genentech; IMpower110 ClinicalTrials.gov number, NCT02409342.).",2020,"Among all the patients who could be evaluated for safety, adverse events occurred in 90.2% of the patients in the atezolizumab group and in 94.7% of those in the chemotherapy group; grade 3 or 4 adverse events occurred in 30.1% and 52.5% of the patients in the respective groups.","['572 patients were enrolled', 'PD-L1-Selected Patients with NSCLC', 'patients with metastatic nonsquamous or squamous NSCLC who had not previously received chemotherapy and who had PD-L1 expression on at least 1% of tumor cells or at least 1% of tumor-infiltrating immune cells as assessed by the SP142 immunohistochemical assay', 'patients with NSCLC with high PD-L1 expression, regardless of histologic type', 'patients with metastatic non-small-cell lung cancer (NSCLC']","['atezolizumab', 'atezolizumab or chemotherapy', 'platinum-based chemotherapy', 'Atezolizumab']","['Overall survival', 'overall survival and progression-free survival', 'adverse events', 'safety, adverse events', 'median overall survival', 'Overall and progression-free survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4509816', 'cui_str': 'Squamous non-small cell lung cancer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449574', 'cui_str': 'Histologic type'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",572.0,0.10554,"Among all the patients who could be evaluated for safety, adverse events occurred in 90.2% of the patients in the atezolizumab group and in 94.7% of those in the chemotherapy group; grade 3 or 4 adverse events occurred in 30.1% and 52.5% of the patients in the respective groups.","[{'ForeName': 'Roy S', 'Initials': 'RS', 'LastName': 'Herbst', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Giaccone', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Marinis', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Reinmuth', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Vergnenegre', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Carlos H', 'Initials': 'CH', 'LastName': 'Barrios', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Morise', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Andric', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Sarayut', 'Initials': 'S', 'LastName': 'Geater', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zou', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sandler', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Enquist', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Komatsubara', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kuriki', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Wen', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McCleland', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Simonetta', 'Initials': 'S', 'LastName': 'Mocci', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Jassem', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Spigel', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}]",The New England journal of medicine,['10.1056/NEJMoa1917346']
1939,33002792,Collaborative Care Model Based Telerehabilitation Exercise Training Program for Acute Stroke Patients in China: A Randomized Controlled Trial.,"BACKGROUND


Early rehabilitation has been proved very important for stroke patients. However, the effective model of transitioning from early in-hospital rehabilitation to discharge rehabilitation using the collaborative remote rehabilitation nursing model has not been thoroughly studied.
OBJECTIVE


To explore the feasibility and effectiveness of collaborative care model based telerehabilitation exercise training for acute stroke patients.
METHODS


A randomized controlled clinical trial was conducted. Patients were recruited and randomly divided into intervention and control group. Both groups were given regular treatment and acute rehabilitation nursing instructions during hospitalization. The control group was followed by regular telephone follow-up after discharge. The intervention group received Internet-based remote rehabilitation project after discharge. Motor function, balance ability and quality of life were measured at the day of discharge, the 4 th  week, 8 th  week and 12 th  week after patients were discharged. The CONSORT checklist was used to check the procedure.
RESULTS


A total of 61 patients completed the study, 30 cases in the intervention group and 31 cases in the control group. Both groups were significantly improved in terms of motor function and quality of life, but the intervention group showed greater improvement in Fugl-Meyer Motor Function Assessment (intervention group = 83.70 ± 4.44, control group = 75.29 ± 2.89), Berg Balance Scale (intervention group = 43.13 ± 2.32, control group = 38.29 ± 2.70) and Stroke-Specific Quality of Life Scale (intervention group = 190.57 ± 5.09, control group = 175.90 ± 5.78). Group-time interaction was significant in motor function and quality of life.
CONCLUSION


Collaborative care model based telerehabilitation exercise training program can safely and effectively improve the recovery of motor function and improve the quality of life in patients with stroke.",2020,"Both groups were significantly improved in terms of motor function and quality of life, but the intervention group showed greater improvement in Fugl-Meyer Motor Function Assessment (intervention group = 83.70 ± 4.44, control group = 75.29 ± 2.89), Berg Balance Scale (intervention group = 43.13 ± 2.32, control group = 38.29 ± 2.70) and Stroke-Specific Quality of Life Scale (intervention group = 190.57 ± 5.09, control group = 175.90 ± 5.78).","['Acute Stroke Patients in China', 'acute stroke patients', 'stroke patients', '61 patients completed the study, 30 cases in the intervention group and 31 cases in the control group', 'patients with stroke']","['Collaborative Care Model Based Telerehabilitation Exercise Training Program', 'collaborative care model based telerehabilitation exercise training', 'Internet-based remote rehabilitation project']","['Fugl-Meyer Motor Function Assessment', 'Berg Balance Scale', 'motor function and quality of life', 'Motor function, balance ability and quality of life', 'quality of life', 'Stroke-Specific Quality of Life Scale', 'recovery of motor function']","[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}]",61.0,0.0446921,"Both groups were significantly improved in terms of motor function and quality of life, but the intervention group showed greater improvement in Fugl-Meyer Motor Function Assessment (intervention group = 83.70 ± 4.44, control group = 75.29 ± 2.89), Berg Balance Scale (intervention group = 43.13 ± 2.32, control group = 38.29 ± 2.70) and Stroke-Specific Quality of Life Scale (intervention group = 190.57 ± 5.09, control group = 175.90 ± 5.78).","[{'ForeName': 'Zhishui', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of neurology, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China. Electronic address: 958414840@qq.com.'}, {'ForeName': 'Jingjuan', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Outpatient Office, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China. Electronic address: 13255107918@163.com.'}, {'ForeName': 'Chunxian', 'Initials': 'C', 'LastName': 'Yue', 'Affiliation': 'Department of neurology, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China. Electronic address: 1210906885@qq.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Tzu Chi elderly care service center, Changzhou, Jiangsu, China. Electronic address: 18262284203@qq.com.'}, {'ForeName': 'Yongchun', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'School of nursing, Taihu University of Wuxi, Wuxi, Jiangsu, China. Electronic address: yongchun0526@163.com.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105328']
1940,33002839,A body-weight-supported visual feedback system for gait recovering in stroke patients: A randomized controlled study.,"OBJECTIVE


The aim of this study was to determine the effectiveness of a novel body-weight-supported (BWS) gait training system with visual feedback, called Copernicus® (Rehalife, Italy). This computerized device provides comfortable, regular and repeatable locomotion in hemiplegic patients. Through visual real-time monitoring of gait parameters, patients are trained to transfer weight loading alternately on both feet.
DESIGN


A single-blind, randomized controlled study. A single center used a computer-generated randomization code to allocate treatments.
SETTING


Intensive rehabilitation unit (IRU) at the Institute S. Anna (Italy).
PARTICIPANTS


63 first-ever stroke patients (39 men, age: 66.1 ± 9.6 years; 61.6 % with left-sided lesion) randomly distributed into three demographically/clinically matched groups.
TREATMENTS


All groups were treated five times a week for 2 -h sessions for six consecutive weeks. The first group (""control"") underwent a conventional physical therapy; the second group performed advanced BWS gait training sessions without visual feedback (Experimental VF- group); whereas the third group used BWS with visual feedback stimulation (Experimental VF+ group).
MAIN OUTCOME MEASURES


Absolute changes were recorded using conventional clinical scales and kinematic measurement of static gait balance from baseline to follow-up.
RESULTS


Significant interaction Group*Time effects scales (F 2,126  = 5.1, p-level = 0.005, η² p  = 0.25; F 2,126  = 4.7, p-level = 0.007, η² p  = 0.19; respectively) were detected in the Functional Independence Measure and Tinetti-Balance scales. Post hoc analysis demonstrated that the recovery of motor functioning was greater for the VF + group with respect to other groups (all p's ≤ 0.001). A similar pattern of findings was also obtained with a stabilometric analysis, demonstrating a better clinical improvement in static balance after VF + treatment.
CONCLUSION


The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.",2020,The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.,"['hemiplegic patients', 'Intensive rehabilitation unit (IRU) at the Institute S. Anna (Italy', 'gait recovering in stroke patients', '63 first-ever stroke patients (39 men, age: 66.1 ± 9.6 years; 61.6 % with left-sided lesion) randomly distributed into three demographically/clinically matched groups']","['conventional physical therapy; the second group performed advanced BWS gait training sessions without visual feedback (Experimental VF- group); whereas the third group used BWS with visual feedback stimulation (Experimental VF+ group', 'novel body-weight-supported (BWS) gait training system with visual feedback, called Copernicus® (Rehalife, Italy', 'body-weight-supported visual feedback system']","['Group*Time effects scales', 'gait recovery', 'static balance', 'Functional Independence Measure and Tinetti-Balance scales', 'conventional clinical scales and kinematic measurement of static gait balance', 'recovery of motor functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",,0.0295403,The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.,"[{'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Pignolo', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Basta', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Carozzo', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'MariaConcetta', 'Initials': 'M', 'LastName': 'Bilotta', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Todaro', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Serra', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Ciancarelli', 'Affiliation': ""Department of Life, Health and Environmental Sciences, University of L'Aquila, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Tonin', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cerasa', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy; Institute for Biomedical Research and Innovation, National Research Council, (IRIB-CNR), 87050, Mangone, CS, Italy. Electronic address: antonio.cerasa76@gmail.com.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.020']
1941,33004464,"The Impact of Empagliflozin on Obstructive Sleep Apnea, Cardiovascular, and Renal Outcomes: An Exploratory Analysis of the EMPA-REG OUTCOME Trial.","OBJECTIVE


To explore the effects of empagliflozin on the incidence of obstructive sleep apnea (OSA) and its effects on metabolic, cardiovascular (CV), and renal outcomes among participants with or without OSA in the EMPA-REG OUTCOME trial.
RESEARCH DESIGN AND METHODS


Participants with diabetes and CV disease were randomized to empagliflozin (10 and 25 mg) or placebo daily in addition to standard of care. OSA was assessed by investigator report using Medical Dictionary for Regulatory Activities version 18.0, and CV outcomes were independently adjudicated. Analyses were performed using multivariable-adjusted Cox regression models.
RESULTS


OSA was reported in 391 of 7,020 (5.6%) participants at baseline. Those with OSA were more likely to be male (83 vs. 71%) and to have moderate-severe obesity (BMI ≥35 kg/m 2 ; 55 vs. 18%). Over a median of 3.1 years, empagliflozin had similar placebo-adjusted reductions in HbA 1c , waist circumference, and systolic blood pressure, regardless of OSA status, but a larger effect on weight (adjusted mean ± SE difference at week 52: OSA vs. no OSA -2.9 ± 0.5 vs. -1.9 ± 0.1 kg). Incidence of 3-point major adverse CV events, CV death, heart failure hospitalization, and incident or worsening nephropathy in the placebo group was 1.2-2.0-fold higher for those with baseline OSA compared with those without. Empagliflozin significantly reduced the risk for outcomes regardless of OSA status ( P -interaction all > 0.05). Fifty patients reported a new diagnosis of OSA through 7 days after medication discontinuation, and this occurred less often with empagliflozin treatment (hazard ratio 0.48 [95% CI 0.27, 0.83]).
CONCLUSIONS


In EMPA-REG OUTCOME, participants with OSA had greater comorbidity and higher frequency of CV and renal events. Empagliflozin had favorable effects on risk factors and CV and renal outcomes regardless of preexisting OSA and may also reduce the risk for new-onset OSA.",2020,Empagliflozin significantly reduced the risk for outcomes regardless of OSA status ( P -interaction all > 0.05).,"['participants with or without OSA in the EMPA-REG OUTCOME trial', 'Participants with diabetes and CV disease']","['placebo', 'Empagliflozin', 'empagliflozin']","['new diagnosis of OSA', 'OSA status', 'comorbidity and higher frequency of CV and renal events', 'HbA 1c , waist circumference, and systolic blood pressure, regardless of OSA status', 'moderate-severe obesity', 'Incidence of 3-point major adverse CV events, CV death, heart failure hospitalization, and incident or worsening nephropathy', 'metabolic, cardiovascular (CV), and renal outcomes', 'OSA', 'Obstructive Sleep Apnea, Cardiovascular, and Renal Outcomes', 'obstructive sleep apnea (OSA']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0208940', 'cui_str': 'REG1A protein, human'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C2585997', 'cui_str': 'New diagnosis'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.196974,Empagliflozin significantly reduced the risk for outcomes regardless of OSA status ( P -interaction all > 0.05).,"[{'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Neeland', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX ian.neeland@uhhospitals.org.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Eliasson', 'Affiliation': 'Department of Medicine, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Kasai', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Marx', 'Affiliation': 'Department of Internal Medicine I (Cardiology), RWTH University Hospital, Aachen, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Department of Medicine, Wuerzburg University Clinic, Wuerzburg, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Wojeck', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Henry K', 'Initials': 'HK', 'LastName': 'Yaggi', 'Affiliation': 'Section of Pulmonary, Critical Care, and Sleep Medicine, Yale School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Odd Erik', 'Initials': 'OE', 'LastName': 'Johansen', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-1096']
1942,33008479,"A multi-center, randomized controlled trial by the Integrative Management in Japan for Epidemic Disease (IMJEDI study-RCT) on the use of Kampo medicine, kakkonto with shosaikotokakikyosekko, in mild-to-moderate COVID-19 patients for symptomatic relief and prevention of severe stage: a structured summary of a study protocol for a randomized controlled trial.","OBJECTIVES


We aimed to test our hypothesis that additional administration of traditional Japanese (Kampo) medicine, kakkonto (kakkon-to: KT) and shosaikotokakikyosekko (sho-saiko-to-ka-kikyo-sekko: SSKKS), is more effective in relieving symptoms and preventing the onset of severe infection in mild-to-moderate COVID-19 patients compared to those treated only with conventional treatment.
TRIAL DESIGN


The study is designed as a multi-center, interventional, parallel-group, randomized (1:1 ratio), investigator-sponsored, two-arm study.
PARTICIPANTS


Patients and inpatients will be recruited from 8 Japanese academic and non-academic hospitals. The inclusion and exclusion criteria are as follows: Inclusion criteria: 1. Diagnosed as positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 2. Clinical stages of mild-to-moderate COVID-19 3. Symptomatic 4. ≥ 20 years of age 5. Male or female 6. Ability to communicate in Japanese 7. Outpatients and inpatients 8. Provided informed consent Exclusion criteria: 1. Difficulty in providing informed consent due to dementia, psychosis, or psychiatric symptoms 2. Allergic to Kampo or Western medicines used in this study 3. Pregnant and lactating 4. Unable to follow up 5. Participating in another clinical trial or interventional study 6. Hypokalemic or taking oral furosemide or steroids 7. Determined unsuitable for this study by the physician INTERVENTION AND COMPARATOR: Patients in the control group will receive conventional treatment with antipyretics, painkillers, or antitussives for symptoms that occurred after they contracted the SARS-CoV-2 infection. Patients in the Kampo group will receive 2.5 g of KT (TJ-1@TSUMURA and Co.) and 2.5 g of SSKKS (TJ-109@TSUMURA and Co.) 3 times a day, orally, for 14 days in addition to the conventional treatment as mentioned above.
MAIN OUTCOMES


The number of days till at least one of the symptoms (fever, cough, sputum, malaise, shortness of breath) improves in the first 14 days of treatment. To assess the cough, sputum, malaise, and shortness of breath, a numeric rating scale will be used to define improvement in terms of a 2-point decrease in the number of days from the start of treatment for at least 2 days. Fever will be defined as an improvement when the temperature is less than 37 °C.
RANDOMIZATION


Patients are randomized (1:1 ratio) to each group using the minimization method, with balancing of the arms with severity of disease stage and patient age (< 65, 65 to < 75, or ≥ 75 years). Computer-generated random numbers will be used for the minimization method.
BLINDING (MASKING)


Open-label with no blinding NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): The main research hypothesis of this study is that the combination of Kampo medicine and conventional treatment will significantly improve the patients' symptoms (fever, fatigue, cough, sputum, and shortness of breath) during the first 14 days of treatment as compared with conventional treatment alone. Concerning the analysis of the primary endpoint, the duration of time before improvement of at least one of the common cold-like symptoms (fever, malaise, cough, sputum, and shortness of breath) will be estimated using the Kaplan-Meier method, and the survival curves will be compared between groups using the log-rank test. Assuming this method of analysis and based on previous studies reporting the efficacy of Kampo medicine for COVID-19 and H1N1 influenza patients, the median survival time in the Kampo medicine group is estimated as 3 days; this time will be 1.5 times longer in the control group. Assuming a one-sided significance level of 5%, a power of 70%, and an allocation ratio of 1:1, the required sample size is calculated as 126 cases. To compensate for a loss in follow-up, we plan to include 150 cases in both groups (Kampo group = 75, control group = 75).
TRIAL STATUS


Protocol version 1.2 as of August 20, 2020 Recruitment start (expected): October 1, 2020 Recruitment finish (expected): October 31, 2023 TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT) jRCTs021200020 . Registered on August 25, 2020 FULL PROTOCOL: The full protocol is attached as an additional file and is accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"We aimed to test our hypothesis that additional administration of traditional Japanese (Kampo) medicine, kakkonto (kakkon-to: KT) and shosaikotokakikyosekko (sho-saiko-to-ka-kikyo-sekko: SSKKS), is more effective in relieving symptoms and preventing the onset of severe infection in mild-to-moderate COVID-19 patients compared to those treated only with conventional treatment.
","['Male or female 6', '20\u2009years of age 5', 'Protocol version 1.2 as of August 20, 2020 Recruitment start (expected): October 1, 2020 Recruitment finish (expected): October 31, 2023', 'Outpatients and inpatients 8', 'Pregnant and lactating 4', 'Patients and inpatients will be recruited from 8 Japanese academic and non-academic hospitals', 'mild-to-moderate COVID-19 patients for symptomatic relief and prevention of severe stage']","['traditional Japanese (Kampo) medicine, kakkonto (kakkon-to: KT) and shosaikotokakikyosekko (sho-saiko-to-ka-kikyo-sekko', 'Kampo medicine, kakkonto with shosaikotokakikyosekko', 'Hypokalemic or taking oral furosemide', 'Kampo medicine and conventional treatment', 'KT (TJ-1@TSUMURA and Co.) and 2.5\u2009g of SSKKS (TJ-109@TSUMURA and Co', 'Kampo or Western medicines']","[""patients' symptoms (fever, fatigue, cough, sputum, and shortness of breath"", 'median survival time', 'cough, sputum, malaise, and shortness of breath, a numeric rating scale', 'survival curves', 'number of days till at least one of the symptoms (fever, cough, sputum, malaise, shortness of breath', 'duration of time before improvement of at least one of the common cold-like symptoms (fever, malaise, cough, sputum, and shortness of breath']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0291753', 'cui_str': 'kakkon-to'}, {'cui': 'C1138004', 'cui_str': 'shosaiko-to'}, {'cui': 'C0752221', 'cui_str': 'Kampo Medicine'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009443', 'cui_str': 'Common cold'}]",,0.134129,"We aimed to test our hypothesis that additional administration of traditional Japanese (Kampo) medicine, kakkonto (kakkon-to: KT) and shosaikotokakikyosekko (sho-saiko-to-ka-kikyo-sekko: SSKKS), is more effective in relieving symptoms and preventing the onset of severe infection in mild-to-moderate COVID-19 patients compared to those treated only with conventional treatment.
","[{'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Takayama', 'Affiliation': 'Department of Kampo Medicine, Tohoku University Hospital, 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan. takayama@med.tohoku.ac.jp.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Namiki', 'Affiliation': 'Department of Japanese-Oriental (Kampo) Medicine, Graduate School of Medicine, Chiba University, 1-8-1, Inohana, Chuo-ku, Chiba, 260-8670, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Akashi Clinic Kanda, 3-8, Kandaogawa-machi, Chiyoda-ku, Tokyo, 101-0052, Japan.'}, {'ForeName': 'Ryutaro', 'Initials': 'R', 'LastName': 'Arita', 'Affiliation': 'Department of Kampo Medicine, Tohoku University Hospital, 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Nakae', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Akita University Graduate School of Medicine, 1-1-1, Hondo, Akita, 010-8543, Japan.'}, {'ForeName': 'Seiichi', 'Initials': 'S', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Respiratory Medicine, Japanese Red Cross Ishinomaki Hospital, Nishimichishita-71, Hebita, Ishinomaki, 986-8522, Japan.'}, {'ForeName': 'Tetsuhiro', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'Center for Kampo Medicine, Keio University School of Medicine, 35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Ishigami', 'Affiliation': 'Department of Cardiology, Yokohama City University Hospital, 3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Traditional Medicine, Faculty of Medicine, Toho University, 6-11-1, Omori-nishi, Ota-ku, Tokyo, 143-8541, Japan.'}, {'ForeName': 'Mosaburo', 'Initials': 'M', 'LastName': 'Kainuma', 'Affiliation': 'Community Medicine Education Unit, Graduate School of Medical Sciences, Kyushu University, 3-1-1, Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Nochioka', 'Affiliation': 'Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.'}, {'ForeName': 'Airi', 'Initials': 'A', 'LastName': 'Takagi', 'Affiliation': 'Clinical Research Data Center, Tohoku University Hospital, 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics, Tohoku University Graduate School of Medicine, 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Ishii', 'Affiliation': 'Department of Kampo Medicine, Tohoku University Hospital, 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}]",Trials,['10.1186/s13063-020-04746-9']
1943,33019392,Gestational diabetes mellitus in women increased the risk of neonatal infection via inflammation and autophagy in the placenta.,"BACKGROUND


Gestational diabetes mellitus (GDM) produces numerous problems for maternal and fetal outcomes. However, the precise molecular mechanisms of GDM are not clear.
METHODS


In our study, we randomly assigned 22 pregnant women with fasting glucose concentrations, 1 hour oral glucose tolerance test (1H-OGTT) and 2 hour oral glucose tolerance test (2H-OGTT), different than 28 normal pregnant women from a sample of 107 pregnant women at the First Affiliated Hospital of Jinan University in China. Lipopolysaccharide (LPS), interleukin 1 alpha (IL-1α), interleukin-6 (IL-6), interleukin-8 (IL-8) and tumor necrosis factor alpha (TNF-α) were measured from blood plasma of pregnant women and umbilical arteries using ultraviolet spectrophotometry. Hematoxylin & Eosin (H&E), Periodic acid-Schiff (PAS) or Masson staining were performed to examine whether diabetes mellitus altered the morphology of placenta. Quantitative PCR (Q-PCR), western blotting and immunofluorescent staining were performed to examine whether diabetes mellitus and autophagy altered the gene expressions of the placental tissue.
RESULTS


We found that women with GDM exhibited increased placental weight and risk of neonatal infection. The concentrations of IL-6 protein and IL-8 protein in GDM were increased in both maternal and umbilical arterial blood. H&E, Masson and PAS staining results showed an increased number of placental villi and glycogen deposition in patients with GDM, but no placental sclerosis was found. Q-PCR results suggested that the expression levels of HIF-1α and the toll like receptor 4 (TLR4)/ myeloid differential protein-88 (MyD88)/ nuclear factor kappa-B (NF-κB) pathway were increased in the GDM placenta. Through Western Blotting, we found that the expression of NF-kappa-B inhibitor alpha (IKBα) and Nuclear factor-κB p65 (NF-κB p65) in GDM placenta was significantly enhanced. We also showed that the key autophagy-related genes, autophagy-related 7 (ATG7) and microtubule-associated protein 1A/1B-light chain 3 (LC3), were increased in GDM compared with normal pregnant women.
CONCLUSIONS


Our results suggest that women with GDM exhibit an increased risk of neonatal infection via inflammation and autophagy in the placenta.",2020,The concentrations of IL-6 protein and IL-8 protein in GDM were increased in both maternal and umbilical arterial blood.,"['women with GDM', 'Gestational diabetes mellitus (GDM', '22 pregnant women with fasting glucose concentrations, 1 hour oral glucose tolerance test (1H-OGTT) and 2 hour oral glucose tolerance test (2H-OGTT), different than 28 normal pregnant women from a sample of 107 pregnant women at the First Affiliated Hospital of Jinan University in China']","['Periodic acid-Schiff (PAS) or Masson staining', 'Hematoxylin & Eosin']","['concentrations of IL-6 protein and IL-8 protein in GDM', 'risk of neonatal infection via inflammation and autophagy', 'Quantitative PCR (Q-PCR), western blotting and immunofluorescent staining', 'expression of NF-kappa-B inhibitor alpha (IKBα) and Nuclear factor-κB p65 (NF-κB p65) in GDM placenta', 'Gestational diabetes mellitus', 'expression levels of HIF-1α and the toll like receptor 4 (TLR4)/ myeloid differential protein-88 (MyD88)/ nuclear factor kappa-B (NF-κB) pathway', 'number of placental villi and glycogen deposition', 'Lipopolysaccharide (LPS), interleukin 1 alpha (IL-1α), interleukin-6 (IL-6), interleukin-8 (IL-8) and tumor necrosis factor alpha (TNF-α', 'placental weight and risk of neonatal infection', 'placental sclerosis']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0440048', 'cui_str': 'Periodic acid Schiff stain'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0018964', 'cui_str': 'Hematoxylin stain'}, {'cui': 'C0014448', 'cui_str': 'Eosine Yellowish'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0854706', 'cui_str': 'Neonatal infection'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0004391', 'cui_str': 'Autophagocytosis'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0005863', 'cui_str': 'Western Blotting'}, {'cui': 'C0183489', 'cui_str': 'Immunofluorescent stain'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C2002434', 'cui_str': 'NFKBIA protein, human'}, {'cui': 'C0299809', 'cui_str': 'PAK2 Kinase'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0439677', 'cui_str': 'Myeloid'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0079904', 'cui_str': 'Immunoglobulin Enhancer-Binding Protein'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008508', 'cui_str': 'Chorionic villi structure'}, {'cui': 'C0333566', 'cui_str': 'Glycogen deposition'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0600251', 'cui_str': 'interleukin-1, alpha'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0036429', 'cui_str': 'Sclerosis'}]",22.0,0.04294,The concentrations of IL-6 protein and IL-8 protein in GDM were increased in both maternal and umbilical arterial blood.,"[{'ForeName': 'Yi-Xiao', 'Initials': 'YX', 'LastName': 'Li', 'Affiliation': 'The First Affiliate Hospital of Jinan University.'}, {'ForeName': 'Deng-Lu', 'Initials': 'DL', 'LastName': 'Long', 'Affiliation': 'International Joint Laboratory for Embryonic Development & Prenatal Medicine, Division of Histology and Embryology, Medical College.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'The First Affiliate Hospital of Jinan University.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Qiu', 'Affiliation': 'The First Affiliate Hospital of Jinan University.'}, {'ForeName': 'Jingyun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'The First Affiliate Hospital of Jinan University.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'International Joint Laboratory for Embryonic Development & Prenatal Medicine, Division of Histology and Embryology, Medical College.'}, {'ForeName': 'Xuesong', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'International Joint Laboratory for Embryonic Development & Prenatal Medicine, Division of Histology and Embryology, Medical College.'}, {'ForeName': 'Rui-Man', 'Initials': 'RM', 'LastName': 'Li', 'Affiliation': 'The First Affiliate Hospital of Jinan University.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'International Joint Laboratory for Embryonic Development & Prenatal Medicine, Division of Histology and Embryology, Medical College.'}]",Medicine,['10.1097/MD.0000000000022152']
1944,33019428,Delivery mode-associated gut microbiota in the first 3 months of life in a country with high obesity rates: A descriptive study.,"Delivery methods during childbirth and their related gut microbiota profiles have important impacts on health later in life, they can contribute to the development of diseases such as obesity, whose highest prevalence rate is found among the Mexican child population. Coincidentally, Mexico has one of the highest global average annual rate increase in cesarean births (C-section). Since Mexico leads the world in childhood obesity, studying the relationship between childbirth delivery methods and gut microbiota profiles in this vulnerable population may be used to identify early risk factors for obesity in other developed and developing countries. The objective of this study is to determine the association between child delivery method and gut microbiota profiles in healthy Mexican newborns.Fecal samples of 57 term infants who participated in a randomized clinical trial in 2013 to study the safety of Agave fructans in newborns, were used in this study. DNA samples were extracted and used to characterize the microbiota composition using high-throughput 16S rRNA gene sequencing. The samples were further divided based on childbirth delivery method, as well as early diet. Gut microbiota profiles were determined and analyzed using cluster analysis followed by multiple correspondence analysis.An unusual high abundance of Proteobacteria was found in the gut microbiota of all Mexican infants studied, regardless of delivery method. Feces from infants born by C-section had low levels of Bacteroidetes, high levels of Firmicutes, especially Clostridium and Enterococcus, and a strikingly high ratio of Firmicutes/Bacteroidetes (F:B). Profiles enriched in Bacteroidetes and low F:B ratios, were strongly associated with vaginal delivery.The profile of gut microbiota associated with feces from Mexican infants born by C-section, may be added to the list of boosting factors for the worrying obesity epidemic in Mexico.",2020,"An unusual high abundance of Proteobacteria was found in the gut microbiota of all Mexican infants studied, regardless of delivery method.","['a country with high obesity rates', '57 term infants who participated in a randomized clinical trial in 2013 to study the safety of Agave fructans in newborns', 'healthy Mexican newborns', 'Mexican infants born by C-section']",[],['Gut microbiota profiles'],"[{'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0331584', 'cui_str': 'Agave'}, {'cui': 'C0016743', 'cui_str': 'Levans'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]",[],"[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",57.0,0.0184582,"An unusual high abundance of Proteobacteria was found in the gut microbiota of all Mexican infants studied, regardless of delivery method.","[{'ForeName': 'Chiharu', 'Initials': 'C', 'LastName': 'Murata', 'Affiliation': 'Research Methodology Department. National Institute of Pediatrics, Mexico.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Gutiérrez-Castrellón', 'Affiliation': 'General Hospital Dr. Manuel Gea González.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pérez-Villatoro', 'Affiliation': 'Winter Genomics.'}, {'ForeName': 'Itzhel', 'Initials': 'I', 'LastName': 'García-Torres', 'Affiliation': 'Group of Research on Biomolecules and Infant Health, IEM&S Lab. INP, México.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Enríquez-Flores', 'Affiliation': 'Group of Research on Biomolecules and Infant Health, IEM&S Lab. INP, México.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'de la Mora-de la Mora', 'Affiliation': 'Group of Research on Biomolecules and Infant Health, IEM&S Lab. INP, México.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Fernández-Lainez', 'Affiliation': 'Laboratory of Inborn Errors of Metabolism and Screening, INP, and Postgraduate in Biological Sciences, UNAM, México. Actual Address: Immunoendocrinology, Division of Medical Biology, Department of Pathology and Medical Biology, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Julieta', 'Initials': 'J', 'LastName': 'Werner', 'Affiliation': 'Indigenous Services Canada, Thunder Bay, Ontario, Canada.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'López-Velázquez', 'Affiliation': 'Group of Research on Biomolecules and Infant Health, IEM&S Lab. INP, México.'}]",Medicine,['10.1097/MD.0000000000022442']
1945,33017456,"Effect of a 90 g/day low-carbohydrate diet on glycaemic control, small, dense low-density lipoprotein and carotid intima-media thickness in type 2 diabetic patients: An 18-month randomised controlled trial.","AIM


This study explored the effect of a moderate (90 g/d) low-carbohydrate diet (LCD) in type 2 diabetes patients over 18 months.
METHODS


Ninety-two poorly controlled type 2 diabetes patients aged 20-80 years with HbA1c ≥7.5% (58 mmol/mol) in the previous three months were randomly assigned to a 90 g/d LCD r traditional diabetic diet (TDD). The primary outcomes were glycaemic control status and change in medication effect score (MES). The secondary outcomes were lipid profiles, small, dense low-density lipoprotein (sdLDL), serum creatinine, microalbuminuria and carotid intima-media thickness (IMT).
RESULTS


A total of 85 (92.4%) patients completed 18 months of the trial. At the end of the study, the LCD and TDD group consumed 88.0±29.9 g and 151.1±29.8 g of carbohydrates, respectively (p < 0.05). The 18-month mean change from baseline was statistically significant for the HbA1c (-1.6±0.3 vs. -1.0±0.3%), 2-h glucose (-94.4±20.8 vs. -18.7±25.7 mg/dl), MES (-0.42±0.32 vs. -0.05±0.24), weight (-2.8±1.8 vs. -0.7±0.7 kg), waist circumference (-5.7±2.7 vs. -1.9±1.4 cm), hip circumference (-6.1±1.8 vs. -2.9±1.7 cm) and blood pressure (-8.3±4.6/-5.0±3 vs. 1.6±0.5/2.5±1.6 mmHg) between the LCD and TDD groups (p<0.05). The 18-month mean change from baseline was not significantly different in lipid profiles, sdLDL, serum creatinine, microalbuminuria, alanine aminotransferase (ALT) and carotid IMT between the groups.
CONCLUSIONS


A moderate (90 g/d) LCD showed better glycaemic control with decreasing MES, lowering blood pressure, decreasing weight, waist and hip circumference without adverse effects on lipid profiles, sdLDL, serum creatinine, microalbuminuria, ALT and carotid IMT than TDD for type 2 diabetic patients.",2020,"The 18-month mean change from baseline was not significantly different in lipid profiles, sdLDL, serum creatinine, microalbuminuria, alanine aminotransferase (ALT) and carotid IMT between the groups.
","['type 2 diabetic patients', 'type 2 diabetes patients over 18 months', 'Ninety-two poorly controlled type', '2 diabetes patients aged 20-80 years with HbA1c ≥7.5% (58 mmol/mol) in the previous three months']","['90 g/day low-carbohydrate diet', 'LCD r traditional diabetic diet (TDD', 'moderate (90 g/d) low-carbohydrate diet (LCD']","['weight', 'glycaemic control status and change in medication effect score (MES', 'blood pressure', 'lipid profiles, small, dense low-density lipoprotein (sdLDL), serum creatinine, microalbuminuria and carotid intima-media thickness (IMT', 'glycaemic control with decreasing MES, lowering blood pressure, decreasing weight, waist and hip circumference without adverse effects on lipid profiles, sdLDL, serum creatinine, microalbuminuria, ALT and carotid IMT', 'waist circumference', 'lipid profiles, sdLDL, serum creatinine, microalbuminuria, alanine aminotransferase (ALT) and carotid IMT', 'hip circumference', '2-h glucose', 'MES']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C4082119', 'cui_str': 'Three months'}]","[{'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0011878', 'cui_str': 'Diabetic diet'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319171', 'cui_str': 'Medication response'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",,0.106199,"The 18-month mean change from baseline was not significantly different in lipid profiles, sdLDL, serum creatinine, microalbuminuria, alanine aminotransferase (ALT) and carotid IMT between the groups.
","[{'ForeName': 'Chin-Ying', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Sheng', 'Initials': 'WS', 'LastName': 'Huang', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Hui-Chuen', 'Initials': 'HC', 'LastName': 'Chen', 'Affiliation': 'Department of Dietetics, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chin-Hao', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Medical Research, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Long-Teng', 'Initials': 'LT', 'LastName': 'Lee', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Heng-Shuen', 'Initials': 'HS', 'LastName': 'Chen', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Yow-Der', 'Initials': 'YD', 'LastName': 'Kang', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chu', 'Initials': 'WC', 'LastName': 'Chie', 'Affiliation': 'Department of Public Health, College of Public Health, Institute of Epidemiology and Preventive Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chyi-Feng', 'Initials': 'CF', 'LastName': 'Jan', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Dean', 'Initials': 'WD', 'LastName': 'Wang', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Jaw-Shiun', 'Initials': 'JS', 'LastName': 'Tsai', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}]",PloS one,['10.1371/journal.pone.0240158']
1946,33000465,"Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2).","BACKGROUND


Tralokinumab, a fully human monoclonal antibody, specifically neutralizes interleukin-13, a key cytokine driving peripheral inflammation in atopic dermatitis (AD). In phase II studies, tralokinumab combined with topical corticosteroids provided early and sustained improvements in AD signs and symptoms.
OBJECTIVES


To evaluate the efficacy and safety of tralokinumab monotherapy in adults with moderate-to-severe AD who had an inadequate response to topical treatments.
METHODS


In two, 52-week, randomized, double-blind, placebo-controlled, phase III trials, ECZTRA 1 and ECZTRA 2, adults with moderate-to-severe AD were randomized (3 : 1) to subcutaneous tralokinumab 300 mg every 2 weeks (Q2W), or placebo. Primary endpoints were IGA score of 0 or 1 at week 16 and EASI 75 at week 16. Patient achieving an IGA score of 0/1 and/or EASI 75 with tralokinumab at week 16 were rerandomized to tralokinumab Q2W or every 4 weeks or placebo, for 36 weeks.
RESULTS


At week 16, more patients who received tralokinumab vs. placebo achieved an IGA score of 0/1: 15·8% vs. 7·1% in ECZTRA 1 [difference (95% CI) 8·6% (4·1-13·1); P = 0·002] and 22·2% vs. 10·9% in ECZTRA 2 [11·1% (5·8-16·4); P < 0·001] and EASI 75: 25·0% vs. 12·7% [12·1% (6·5-17·7); P < 0·001] and 33·2% vs. 11·4% [21·6% (15·8-27·3); P < 0·001]. Early improvements in pruritus, sleep interference, Dermatology Life Quality Index, SCORing Atopic Dermatitis and Patient-Oriented Eczema Measure were observed from the first postbaseline measurements. The majority of week 16 tralokinumab-responders maintained response at week 52 with continued tralokinumab treatment without any rescue medication (including topical corticosteroids). Adverse events were reported in 76·4% and 61·5% of patients receiving tralokinumab and in 77·0% and 66·0% of patients receiving placebo in the 16-week initial period.
CONCLUSIONS


Tralokinumab monotherapy was superior to placebo at 16 weeks of treatment and was well tolerated up to 52 weeks of treatment.",2020,Tralokinumab monotherapy was superior to placebo at 16 weeks of treatment and was well tolerated up to 52 weeks of treatment.,"['adults with moderate-to-severe AD', 'moderate-to-severe atopic dermatitis', 'adults with moderate-to-severe AD who had an inadequate response to topical treatments']","['Tralokinumab monotherapy', 'tralokinumab combined with topical corticosteroids', 'subcutaneous tralokinumab 300\xa0mg every 2\xa0weeks (Q2W), or placebo', 'tralokinumab monotherapy', 'placebo', 'Tralokinumab', 'tralokinumab vs. placebo', 'tralokinumab treatment without any rescue medication (including topical corticosteroids']","['pruritus, sleep interference, Dermatology Life Quality Index, SCORing Atopic Dermatitis and Patient-Oriented Eczema Measure', 'efficacy and safety', 'Adverse events', 'IGA score', 'AD signs and symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3658667', 'cui_str': 'tralokinumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C4304942', 'cui_str': 'POEM - Patient-Oriented Eczema Measure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]",,0.499857,Tralokinumab monotherapy was superior to placebo at 16 weeks of treatment and was well tolerated up to 52 weeks of treatment.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Department of Dermatology and Allergy, Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology and the Immunology Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Worm', 'Affiliation': 'Division of Allergy and Immunology, Department of Dermatology, Venereology and Allergy, Charité -Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lynde', 'Affiliation': 'Lynde Dermatology, Probity Medical Research, Markham, Ontario, Canada, and Department of Medicine, University of Toronto, Ontario, Canada.'}, {'ForeName': 'J-P', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': 'Department of Dermatology, University Hospital of Nice, Nice, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Spelman', 'Affiliation': 'Veracity Clinical Research, Brisbane, Queensland, Australia, and Probity Medical Research, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Katoh', 'Affiliation': 'Department of Dermatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Saeki', 'Affiliation': 'Department of Dermatology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Poulin', 'Affiliation': 'Laval University and Centre Dermatologique du Québec Métropolitain and Centre de Recherche Dermatologique du Québec Métropolitain, Québec, Quebec City, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lesiak', 'Affiliation': 'Department of Dermatology and Pediatric and Oncologic Dermatology, Medical University of Łódź, Łódź, Poland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kircik', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA, and Indiana University Medical Center, Indianapolis, IN, USA.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Department of Dermatology, The Catholic University of Korea, Seoul, South Korea.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Herranz', 'Affiliation': 'Department of Dermatology, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Cork', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity, and Cardiovascular Disease, The University of Sheffield and Sheffield Teaching Hospitals NIHR Clinical Research Facility, Sheffield, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Peris', 'Affiliation': 'Dermatology, Catholic University and Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Steffensen', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bang', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kuznetsova', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'T N', 'Initials': 'TN', 'LastName': 'Jensen', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Østerdal', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, OR, USA.'}]",The British journal of dermatology,['10.1111/bjd.19574']
1947,33002553,Comparative clinical study evaluating the effect of adding Vildagliptin versus Glimepiride to ongoing Metformin therapy on diabetic patients with symptomatic coronary artery disease.,"BACKGROUND AND OBJECTIVE


Cardiovascular diseases (CVDs) remain the most identified cause of death in patients with diabetes mellitus (DM). This study aimed to evaluate the effect of adding Vildagliptin versus Glimepiride to ongoing Metformin on the biomarkers of inflammation, thrombosis, and atherosclerosis in T2DM patients with symptomatic coronary artery disease (CAD).
METHODS


This study included 80 patients with uncontrolled T2DM and symptomatic CAD who were randomized to add either Vildagliptin 50 mg/day ""group I"" or Glimepiride 4 mg/day ""group II"" to ongoing Metformin therapy (1000 mg/day). Blood samples were collected at baseline and 3 months after intervention for biochemical analysis of HbA1c %, IL-1β, adiponectin, hsCRP and lipid profile. Additionally atherogenic index (AI) and coronary risk index (CRI) were determined.
RESULTS


Three months after intervention and as compared to group II (Glimepiride/Metformin), group 1 (Vildagliptin/Metformin) showed significantly lower BMI (28.73 ± 3.48 versus 30.55 ± 3.15; p = 0.02), HbA1c (6.05 ± 0.72 versus 7.06 ± 0.89; p < 0.0001), hsCRP (0.96 ± 0.20 versus 1.72 ± 0.38; p < 0.0001), IL-1β (34.95 ± 10.01 versus 45.13 ± 10.26; p < 0.0001), TC (136 ± 23.45 versus 169 ± 35.72; p < 0.0001), TG (116 ± 29.10 versus 146 ± 56.58; p = 0.005), and CRI (2.47 ± 0.90 versus 3.65 ± 1.19; p < 0.0001) which was associated with significantly higher adiponectin and HDL-C (4.42 ± 1.29 versus 2.52 ± 1.86; p < 0.0001 and 61 ± 23.04 versus 48 ± 12.92; p = 0.003 respectively).
CONCLUSION


In patients with T2DM and symptomatic CAD, the addition of Vildagliptin to ongoing metformin showed better glycemic control, lower inflammatory markers (IL-1β and hsCRP), higher protective markers (adiponectin and HDL-C) and improved lipid profile compared to Glimepiride/metformin therapy.",2020,"In patients with T2DM and symptomatic CAD, the addition of Vildagliptin to ongoing metformin showed better glycemic control, lower inflammatory markers (IL-1β and hsCRP), higher protective markers (adiponectin and HDL-C) and improved lipid profile compared to Glimepiride/metformin therapy.","['T2DM patients with symptomatic coronary artery disease (CAD', 'patients with diabetes mellitus (DM', '80 patients with uncontrolled T2DM and symptomatic CAD', 'Diabetic Patients with Symptomatic Coronary Artery Disease']","['Vildagliptin', 'Glimepiride', 'Glimepiride/metformin', 'Vildagliptin 50 mg/day ""group', 'Metformin therapy', 'Glimepiride/Metformin', 'Vildagliptin/Metformin', 'Metformin Therapy', 'Metformin']","['BMI', 'CRI', 'Additionally atherogenic index (AI) and coronary risk index (CRI', 'glycemic control, lower inflammatory markers (IL-1β and hsCRP), higher protective markers (adiponectin and HDL-C) and improved lipid profile', 'Blood samples', 'adiponectin and HDL-C', 'biomarkers of inflammation, thrombosis, and atherosclerosis', 'hsCRP', 'IL-1β']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2240780', 'cui_str': 'vildagliptin 50 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]",80.0,0.0534605,"In patients with T2DM and symptomatic CAD, the addition of Vildagliptin to ongoing metformin showed better glycemic control, lower inflammatory markers (IL-1β and hsCRP), higher protective markers (adiponectin and HDL-C) and improved lipid profile compared to Glimepiride/metformin therapy.","[{'ForeName': 'Rehab', 'Initials': 'R', 'LastName': 'Werida', 'Affiliation': 'Clinical Pharmacy & Pharmacy Practice Department, Faculty of Pharmacy, Damanhour University, Egypt. Electronic address: rehabwrieda@pharm.dmu.edu.eg.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Kabel', 'Affiliation': 'Clinical Pharmacy Unit, Alexandria Armed Forces Hospital, Egypt.'}, {'ForeName': 'Gamal', 'Initials': 'G', 'LastName': 'Omran', 'Affiliation': 'Biochemistry Department, Faculty of Pharmacy, Damanhour University, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Shokry', 'Affiliation': 'Cardiology Department, Alexandria Armed Forces Hospital, Egypt.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Mostafa', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Egypt.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108473']
1948,33003091,"Comment on ""Acupuncture for Pain in Chronic Pancreatitis A Single-Blinded Randomized Crossover Trial"".",,2020,,['Chronic Pancreatitis'],['Acupuncture'],[],"[{'cui': 'C0149521', 'cui_str': 'Chronic pancreatitis'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]",[],,0.313541,,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Lindebjerg', 'Affiliation': 'Department of Pathology Vejle Hospital Vejle, Denmark jan.lindebjerg@rsyd.dk.'}]",Pancreas,['10.1097/MPA.0000000000001640']
1949,33004239,"DAR-901 vaccine for the prevention of infection with Mycobacterium tuberculosis among BCG-immunized adolescents in Tanzania: A randomized controlled, double-blind phase 2b trial.","BACKGROUND


SRL172 prevented disease due to Mycobacterium tuberculosis in a Phase 3 trial. DAR-901 represents a scalable manufacturing process for SRL172. We sought to determine if DAR-901 would prevent infection with M. tuberculosis among BCG-primed adolescents age 13-15 years in Tanzania.
METHODS


Adolescents with a negative T- SPOT.TB R  interferon gamma release assay (IGRA) were randomized 1:1 to three intradermal injections of DAR-901 or saline placebo at 0, 2 and 4 months. Repeat IGRAs were performed at 2 months, and at 1, 2, and 3 years. The primary efficacy outcome was time to new TB infection (IGRA conversion to positive); the secondary outcome was time to persistent TB infection (IGRA conversion with repeat positive IGRA).
RESULTS


Among 936 participants screened 667 were eligible and randomized to their first dose of vaccine or placebo (safety cohort). At 2 months, 625 participants remained IGRA-negative and were scheduled for the additional two doses (efficacy cohort). DAR-901 was safe and well-tolerated. One DAR-901 recipient developed a vaccine site abscess. Neither the primary nor secondary endpoints differed between the two treatment arms (p = 0.90 and p = 0.20, respectively). DAR-901 IGRA converters had median responses to ESAT-6 of 50.1 spot-forming cells (SFCs) vs. 19.6 SFCs in placebo IGRA converters (p = 0.03).
CONCLUSIONS


A three-dose series of 1 mg DAR-901 was safe and well-tolerated but did not prevent initial or persistent IGRA conversion. DAR-901 recipients with IGRA conversion demonstrated enhanced immune responses to ESAT-6. Since protection against disease may require different immunologic responses than protection against infection a trial of DAR-901 to prevent TB disease is warranted.
TRIAL REGISTRATION


The trial is registered at ClinicalTrials.gov as NCT02712424.",2020,"Neither the primary nor secondary endpoints differed between the two treatment arms (p = 0.90 and p = 0.20, respectively).","['BCG-immunized adolescents in Tanzania', '936 participants screened 667 were eligible and randomized to their first dose of', 'Adolescents with a negative T- SPOT.TB R  interferon gamma release assay (IGRA', 'BCG-primed adolescents age 13-15\xa0years in Tanzania', '625 participants remained IGRA-negative']","['DAR-901 or saline placebo', 'vaccine or placebo', 'IGRA', 'DAR-901', 'DAR-901 vaccine']","['safe and well-tolerated', 'time to new TB infection (IGRA conversion to positive); the secondary outcome was time to persistent TB infection (IGRA conversion with repeat positive IGRA']","[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517851', 'cui_str': '667'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C3178802', 'cui_str': 'Interferon gamma release assay'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517838', 'cui_str': '625'}]","[{'cui': 'C0022595', 'cui_str': 'Darier disease'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3178802', 'cui_str': 'Interferon gamma release assay'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C3178802', 'cui_str': 'Interferon gamma release assay'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]",,0.588273,"Neither the primary nor secondary endpoints differed between the two treatment arms (p = 0.90 and p = 0.20, respectively).","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Munseri', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Jamila', 'Initials': 'J', 'LastName': 'Said', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Amour', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Magohe', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Mecky', 'Initials': 'M', 'LastName': 'Matee', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Christiaan A', 'Initials': 'CA', 'LastName': 'Rees', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Mackenzie', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Tvaroha', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bailey-Kellogg', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Maro', 'Affiliation': 'Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Wieland-Alter', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Lisa V', 'Initials': 'LV', 'LastName': 'Adams', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'C Robert', 'Initials': 'CR', 'LastName': 'Horsburgh', 'Affiliation': 'Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Arbeit', 'Affiliation': 'Tufts University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Kisali', 'Initials': 'K', 'LastName': 'Pallangyo', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'C Fordham', 'Initials': 'CF', 'LastName': 'von Reyn', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA. Electronic address: fvr@dartmouth.edu.'}]",Vaccine,['10.1016/j.vaccine.2020.09.055']
1950,33006190,Human immune cell mobilization during exercise: effect of IL-6 receptor blockade.,"NEW FINDINGS


What is the central question of this study? Does blockade of the IL-6 receptor by tocilizumab inhibit immune cell mobilization to the blood stream in humans during an acute bout of exercise? What is the main finding and its importance? Blockade of IL-6 receptor signalling by tocilizumab attenuates mobilization of NK cells and dendritic cells to the blood stream during exercise. This implies an inhibitory effect of tocilizumab on the innate immune response to physical stress, which could be considered in clinical settings.
ABSTRACT


Immune cells are recruited from their storage organs and the endothelial walls to the blood stream in response to physiological stress. This is essential for the recognition and clearing of infected, transformed or damaged cells. One of the most potent stimuli to recruit immune cells to the circulation is exercise. Accordingly, exercise has proven beneficial in disease settings, such as cancer and diabetes. Interleukin-6 (IL-6) is released from contracting skeletal muscle in response to exercise, and rodent studies have established a link between exercise-induced IL-6 and recruitment of natural killer (NK) cells. Whether exercise-induced IL-6 is involved in regulating NK cell mobilization in humans is unclear. This study explored the effect of IL-6 receptor blockade on immune cell mobilization during an acute bout of exercise in humans. In a randomized, placebo-controlled clinical study, abdominally obese humans receiving placebo infusions or tocilizumab infusions performed an acute bout of exercise before and after the intervention. Immune cell recruitment was measured by flow cytometry. IL-6 receptor blockade attenuated the increase of NK cells by 53% (mean difference -0.49 (95% CI: -0.89 to -0.08) × 10 9  cells L -1  , P < 0.001) and dendritic cells by 66% (mean difference -0.14 (95% CI: -0.28 to 0.010) × 10 9  cells L -1  , P < 0.001) induced by an acute bout of exercises. No changes were observed for T cells, monocytes and neutrophils. Treatments which interact with the exercise-mediated immune surveillance provide relevant clinical information in pursuing the 'exercise as medicine' concept.",2020,"(mean difference and 95% CI), p<0.001) and dendritic cells (DC's) by 66% (-0.14","['abdominally obese humans receiving', 'acute bout of exercise in humans']","['placebo infusions or tocilizumab infusions', 'IL-6', 'placebo', 'tocilizumab', 'IL-6 receptor blockade']","['Immune cell recruitment', 'NK cells', ""dendritic cells (DC's"", 'Interleukin-6 (IL-6', 'T cells, monocytes, and neutrophils']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0003315', 'cui_str': 'Immunologic Accessory Cells'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}]",,0.364042,"(mean difference and 95% CI), p<0.001) and dendritic cells (DC's) by 66% (-0.14","[{'ForeName': 'Marie Lund', 'Initials': 'ML', 'LastName': 'Bay', 'Affiliation': 'Centre of Inflammation and Metabolism and Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Heywood', 'Affiliation': 'Centre of Inflammation and Metabolism and Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Wedell-Neergaard', 'Affiliation': 'Centre of Inflammation and Metabolism and Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Schauer', 'Affiliation': 'Centre of Inflammation and Metabolism and Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Louise Lang', 'Initials': 'LL', 'LastName': 'Lehrskov', 'Affiliation': 'Centre of Inflammation and Metabolism and Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Regitse Højgaard', 'Initials': 'RH', 'LastName': 'Christensen', 'Affiliation': 'Centre of Inflammation and Metabolism and Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Grit Elster', 'Initials': 'GE', 'LastName': 'Legård', 'Affiliation': 'Centre of Inflammation and Metabolism and Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter Østrup', 'Initials': 'PØ', 'LastName': 'Jensen', 'Affiliation': 'Department of Clinical Microbiology, Rigshospitalet, Copenhagen Ø, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Krogh-Madsen', 'Affiliation': 'Centre of Inflammation and Metabolism and Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ellingsgaard', 'Affiliation': 'Centre of Inflammation and Metabolism and Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",Experimental physiology,['10.1113/EP088864']
1951,33007031,Oral intake of mesoporous silica is safe and well tolerated in male humans.,"BACKGROUND


Precisely engineered mesoporous silica has been shown to induce weight loss in mice, but whether it is safe to use in humans have not investigated.
OBJECTIVE


The aim was to determine whether oral dosing, up to 9 grams/day, of precisely engineered mesoporous silica as a food additive can be used safely in male humans.
DESIGN


This single blinded safety study consisted of two study arms including 10 males each (18-35 years). One arm consisted of participants with normal weight and one with obesity. After a placebo run-in period, all subjects were given porous silica three times daily, with increasing dose up to 9 grams/day (Phase 1). Subjects with obesity continued the study with highest dose for additional 10 weeks (Phase 2).
RESULTS


All participants completed Phase 1 and 90% completed Phase 2, with approximately 1% missed doses. Participants reported no abdominal discomfort, and changes in bowel habits were minor and inconsistent. The side effects observed were mild and tolerable, biomarkers did not give any safety concern, and no severe adverse events occurred.
CONCLUSION


Mesoporous silica intake of up to 9 grams/day can be consumed by males without any major adverse events or safety concerns.",2020,"The side effects observed were mild and tolerable, biomarkers did not give any safety concern, and no severe adverse events occurred.
","['male humans', 'Subjects with obesity continued the study with highest dose for additional 10 weeks (Phase 2', '10 males each (18-35 years', 'participants with normal weight and one with obesity']",['placebo'],"['weight loss', 'Mesoporous silica intake', 'abdominal discomfort, and changes in bowel habits']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0037098', 'cui_str': 'Silicon Dioxide'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0232487', 'cui_str': 'Abdominal discomfort'}, {'cui': 'C0278008', 'cui_str': 'Altered bowel function'}]",,0.0774239,"The side effects observed were mild and tolerable, biomarkers did not give any safety concern, and no severe adverse events occurred.
","[{'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Hagman', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Amira', 'Initials': 'A', 'LastName': 'Elimam', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Kupferschmidt', 'Affiliation': 'Department of Molecular Biosciences, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Ekbom', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Rössner', 'Affiliation': 'Apple Bay Obesity Research Centre, Bromma, Sweden.'}, {'ForeName': 'Muhammad Naeem', 'Initials': 'MN', 'LastName': 'Iqbal', 'Affiliation': 'Sigrid Therapeutics AB, Stockholm, Sweden.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Johnston', 'Affiliation': 'Sigrid Therapeutics AB, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lindgren', 'Affiliation': 'Sigrid Therapeutics AB, Stockholm, Sweden.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Bengtsson', 'Affiliation': 'Department of Molecular Biosciences, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Pernilla', 'Initials': 'P', 'LastName': 'Danielsson', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}]",PloS one,['10.1371/journal.pone.0240030']
1952,33007041,Generation of a malaria negative Ugandan birth weight standard for the diagnosis of small for gestational age.,"OBJECTIVE


Placental malaria is a known risk factor for small for gestational age (SGA) neonates. However, currently utilized international and African birthweight standards have not controlled for placental malaria and/or lack obstetrical ultrasound dating. We developed a neonatal birthweight standard based on obstetrically dated pregnancies that excluded individuals with clinical malaria, asymptomatic parasitemia, and placental malaria infection. We hypothesized that current curves underestimate true ideal birthweight and the prevalence of SGA.
STUDY DESIGN


Participants were pooled from two double-blind randomized control trials of intermittent preventive therapy during pregnancy in Uganda. HIV-negative women without comorbidities were enrolled from 12-20 weeks gestation. Gestational age was confirmed by ultrasound dating. Women were followed through pregnancy and delivery for clinical malaria, asymptomatic parasitemia, and placental malaria. Women without malaria, asymptomatic parasitemia, or placental malaria formed the malaria negative cohort and generated the Ugandan birthweight standard. The Ugandan standard was then used to estimate the prevalence of SGA neonates in the malaria positive cohort. These findings were compared to international (Williams, World Health Organization (WHO), and INTERGROWTH-21st) and regional standards (Tanzanian and Malawi).
RESULTS


926 women had complete delivery data; 393 (42.4%) met criteria for the malaria negative cohort and 533 (57.6%) were malaria positive. The Ugandan standard diagnosed SGA in 17.1% of malaria positive neonates; similar to the INTERGROWTH-21st and Schmiegelow curves. The WHO curve diagnosed SGA in significantly more neonates (32.1%, p = <0.001), and the Malawi curve diagnosed SGA in significantly fewer neonates (8.3%, p <0.001).
CONCLUSION


Exclusion of women with subclinical placental malaria in malaria-endemic areas created birth weight norms at higher values and increased the detection of SGA. Birth weight standards that fail to account for endemic illness may underestimate the true growth potential of healthy neonates.",2020,"The WHO curve diagnosed SGA in significantly more neonates (32.1%, p = <0.001), and the Malawi curve diagnosed SGA in significantly fewer neonates (8.3%, p <0.001).
","['individuals with clinical malaria, asymptomatic parasitemia, and placental malaria infection', 'Women without malaria, asymptomatic parasitemia, or placental malaria formed the malaria negative cohort and generated the Ugandan birthweight standard', '926 women had complete delivery data; 393 (42.4%) met criteria for the malaria negative cohort and 533 (57.6%) were malaria positive', 'Participants', 'HIV-negative women without comorbidities were enrolled from 12-20 weeks gestation', 'small for gestational age (SGA) neonates', 'healthy neonates']",['intermittent preventive therapy'],"['malaria negative', 'detection of SGA', 'Malawi curve diagnosed SGA']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",926.0,0.292602,"The WHO curve diagnosed SGA in significantly more neonates (32.1%, p = <0.001), and the Malawi curve diagnosed SGA in significantly fewer neonates (8.3%, p <0.001).
","[{'ForeName': 'Arthurine K', 'Initials': 'AK', 'LastName': 'Zakama', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Terik', 'Initials': 'T', 'LastName': 'Weekes', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kajubi', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Kakuru', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ategeka', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Kamya', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Muhindo', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Havlir', 'Affiliation': 'Department of Medicine, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Jagannathan', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, California, United States of America.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Dorsey', 'Affiliation': 'Department of Medicine, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Gaw', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0240157']
1953,33007106,Dehydroepiandrosterone potentiates the effect of vitamin D on thyroid autoimmunity in euthyroid women with autoimmune thyroiditis: A pilot study.,"The impact of androgens on the thyroid in women is poorly understood. The aim of the present study was to investigate whether vitamin D/dehydroepiandrosterone (DHEA) combination therapy is superior to vitamin D alone in affecting thyroid autoimmunity and hypothalamic-pituitary-thyroid axis activity in young women with autoimmune thyroid disease. The study included 35 euthyroid women with untreated Hashimoto's thyroiditis and reduced sexual drive, allocated to one of two treatment groups. The first group (n = 19) received both vitamin D and DHEA, while the second (n = 16) was treated with only vitamin D. Serum thyroid antibody titres and concentrations of thyrotropin, free thyroid hormones, dehydroepiandrosterone-sulphate (DHEA-S), 25-hydroxyvitamin D, testosterone and estradiol were measured at baseline and 6 months later. Vitamin D administered alone or in combination with DHEA decreased serum titres of thyroid peroxidase and thyroglobulin antibodies, which correlated with baseline antibody titres, baseline 25-hydroxyvitamin D levels and treatment-induced increase in 25-hydroxyvitamin D levels. Apart from a stronger effect on antibody titres, vitamin D/DHEA combination therapy slightly decreased thyrotropin levels, as well as increased DHEA-S and testosterone levels. In this group of women, treatment-induced changes in antibody titres and thyrotropin levels correlated with the impact on DHEA-S and testosterone. The obtained results suggest that vitamin D/DHEA combination therapy may be a better treatment option for euthyroid women with Hashimoto's thyroiditis than vitamin D alone.",2020,"Vitamin D administered alone or in combination with DHEA decreased serum titers of thyroid peroxidase and thyroglobulin antibodies, which correlated with baseline antibody titers, baseline 25-hydroxyvitamin D levels and treatment-induced increase in25-hydroxyvitamin D levels.","[""35 euthyroid women with untreated Hashimoto's thyroiditis and reduced sexual drive, allocated to one of two treatment groups"", 'young women with autoimmune thyroid disease', 'women ispoorly understood', 'euthyroid women with autoimmune thyroiditis', ""euthyroid women with Hashimoto's thyroiditis than vitamin D alone""]","['Dehydroepiandrosterone', 'vitamin D', 'vitamin D and DHEA', 'vitamin D/DHEA combination therapy', 'vitamin D/dehydroepiandrosterone (DHEA) combination therapy', 'Vitamin D administered alone or in combination with DHEA']","['serum titers of thyroid peroxidase and thyroglobulin antibodies', 'in25-hydroxyvitamin D levels', 'DHEA-S and testosterone levels', 'Serum thyroid antibody titers and concentrations of thyrotropin, free thyroid hormones, dehydroepiandrosterone-sulfate (DHEA-S), 25-hydroxyvitamin D, testosterone and estradiol', 'antibody titers and thyrotropin levels', 'baseline antibody titers, baseline 25-hydroxyvitamin D levels', 'thyrotropin levels']","[{'cui': 'C0117002', 'cui_str': 'Euthyroid'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0677607', 'cui_str': 'Hashimoto thyroiditis'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0443146', 'cui_str': 'Autoimmune reaction'}, {'cui': 'C0040128', 'cui_str': 'Disorder of thyroid gland'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0021965', 'cui_str': 'Iodide peroxidase'}, {'cui': 'C0201512', 'cui_str': 'Thyroglobulin antibody measurement'}, {'cui': 'C0020337', 'cui_str': 'Hydroxycholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0700384', 'cui_str': 'Thyroid antibody'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0057277', 'cui_str': 'Dehydroepiandrosterone sulfate'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",35.0,0.197201,"Vitamin D administered alone or in combination with DHEA decreased serum titers of thyroid peroxidase and thyroglobulin antibodies, which correlated with baseline antibody titers, baseline 25-hydroxyvitamin D levels and treatment-induced increase in25-hydroxyvitamin D levels.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Krysiak', 'Affiliation': 'Department of Internal Medicine and Clinical Pharmacology, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Szkróbka', 'Affiliation': 'Department of Internal Medicine and Clinical Pharmacology, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Bogusław', 'Initials': 'B', 'LastName': 'Okopień', 'Affiliation': 'Department of Internal Medicine and Clinical Pharmacology, Medical University of Silesia, Katowice, Poland.'}]",Clinical and experimental pharmacology & physiology,['10.1111/1440-1681.13410']
1954,33007285,Intravenous versus oral antibiotics for eradication of Pseudomonas aeruginosa in cystic fibrosis (TORPEDO-CF): a randomised controlled trial.,"BACKGROUND


Chronic pulmonary infection with Pseudomonas aeruginosa is one of the most important causes of mortality and morbidity in cystic fibrosis. If antibiotics are commenced promptly, infection can be eradicated. The aim of the trial was to compare the effectiveness and safety of intravenous ceftazidime and tobramycin versus oral ciprofloxacin in the eradication of P aeruginosa.
METHODS


We did a multicentre, parallel group, open-label, randomised controlled trial in 72 cystic fibrosis centres (70 in the UK and two in Italy). Eligible participants were older than 28 days with an isolate of P aeruginosa (either the first ever isolate or a new isolate after at least 1 year free of infection). Participants were excluded if the P aeruginosa was resistant to, or they had a contraindication to, one or more of the trial antibiotics; if they were already receiving P aeruginosa suppressive therapy; if they had received any P aeruginosa eradication therapy within the previous 9 months; or if they were pregnant or breastfeeding. We used web-based randomisation to assign patients to 14 days intravenous ceftazidime and tobramycin or 12 weeks oral ciprofloxacin. Both were combined with 12 weeks inhaled colistimethate sodium. Randomisation lists were generated by a statistician, who had no involvement in the trial, using a computer-generated list. Randomisation was stratified by centre and because of the nature of the interventions, blinding was not possible. Our primary outcome was eradication of P aeruginosa at 3 months and remaining free of infection to 15 months. Primary analysis used intention to treat (powered for superiority). Safety analysis included patients who received at least one dose of study drug. TORPEDO-CF was registered on the ISRCTN register, ISRCTN02734162, and EudraCT, 2009-012575-10.
FINDINGS


Between Oct 5, 2010, and Jan 27, 2017, 286 patients were randomly assigned to treatment: 137 to intravenous antibiotics and 149 to oral antibiotics. 55 (44%) of 125 participants in the intravenous group and 68 (52%) of 130 participants in the oral group achieved the primary outcome. Participants randomly assigned to the intravenous group were less likely to achieve the primary outcome, although the difference between groups was not statistically significant (relative risk 0·84, 95% CI 0·65-1·09; p=0·18). 11 serious adverse events occurred in ten (8%) of 126 participants in the intravenous antibiotics group and 17 serious adverse events in 12 (8%) of 146 participants in the oral antibiotics group.
INTERPRETATION


Compared with oral therapy, intravenous antibiotics did not achieve sustained eradication of P aeruginosa in a greater proportion of patients with cystic fibrosis and was more expensive. Although there were fewer hospitalisations in the intravenous group than the oral group during follow-up, this confers no advantage over oral treatment because intravenous eradication frequently requires hospitalisation. These results do not support the use of intravenous antibiotics to eradicate P aeruginosa in cystic fibrosis.
FUNDING


National Institute for Health Research Health Technology Assessment Programme.",2020,"Compared with oral therapy, intravenous antibiotics did not achieve sustained eradication of P aeruginosa in a greater proportion of patients with cystic fibrosis and was more expensive.","['Between Oct 5, 2010, and Jan 27, 2017, 286 patients were randomly assigned to treatment', 'cystic fibrosis', 'Participants were excluded if the P aeruginosa was resistant to, or they had a contraindication to, one or more of the trial antibiotics; if they were already receiving P aeruginosa suppressive therapy; if they had received any P aeruginosa eradication therapy within the previous 9 months; or if they were pregnant or breastfeeding', 'patients who received at least one dose of study drug', '72 cystic fibrosis centres (70 in the UK and two in Italy', 'Eligible participants were older than 28 days with an isolate of P aeruginosa (either the first ever isolate or a new isolate after at least 1 year free of infection', 'cystic fibrosis (TORPEDO-CF']","['ciprofloxacin', 'ceftazidime and tobramycin', 'oral antibiotics', 'inhaled colistimethate sodium']","['serious adverse events', 'effectiveness and safety', '11 serious adverse events', 'eradication of P aeruginosa']","[{'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205367', 'cui_str': 'Suppressive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0040478', 'cui_str': 'Torpedo'}]","[{'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0007559', 'cui_str': 'Ceftazidime'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0110462', 'cui_str': 'Colistimethate sodium'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}]",72.0,0.164174,"Compared with oral therapy, intravenous antibiotics did not achieve sustained eradication of P aeruginosa in a greater proportion of patients with cystic fibrosis and was more expensive.","[{'ForeName': 'Simon C Langton', 'Initials': 'SCL', 'LastName': 'Hewer', 'Affiliation': 'Department of Paediatric Respiratory Medicine, Bristol Royal Hospital for Children, University of Bristol, Bristol, UK. Electronic address: UKsimon.langtonhewer@bristol.ac.uk.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Smyth', 'Affiliation': 'Division of Child Health, Obstetrics & Gynaecology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': 'Ashley P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hickey', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': 'Dervla', 'Initials': 'D', 'LastName': 'Kenna', 'Affiliation': 'Antimicrobial Resistance and Healthcare Associated Infections Reference Unit, National Infection Service, Public Health England, London, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ashby', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': 'The University of Manchester, Manchester Centre for Health Economics, Manchester, UK.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Williamson', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30331-3']
1955,33009160,"""Babywearing"" in the NICU: An Intervention for Infants With Neonatal Abstinence Syndrome.","BACKGROUND


The US opioid epidemic has resulted in an increase of infants at risk for developing neonatal abstinence syndrome (NAS). Traditionally, treatment has consisted of pharmacological interventions to reduce symptoms of withdrawal. However, nonpharmacological interventions (eg, skin-to-skin contact, holding) can also be effective in managing the distress associated with NAS.
PURPOSE


The purpose of this study was to examine whether infant carrying or ""babywearing"" (ie, holding an infant on one's body using cloth) can reduce distress associated with NAS among infants and caregivers.
METHODS


Heart rate was measured in infants and adults (parents vs other adults) in a neonatal intensive care unit (NICU) pre- (no touching), mid- (20 minutes into being worn in a carrier), and post-babywearing (5 minutes later).
RESULTS


Using a 3-level hierarchical linear model at 3 time points (pre, mid, and post), we found that babywearing decreased infant and caregiver heart rates. Across a 30-minute period, heart rates of infants worn by parents decreased by 15 beats per minute (bpm) compared with 5.5 bpm for infants worn by an unfamiliar adult, and those of adults decreased by 7 bpm (parents) and nearly 3 bpm (unfamiliar adult).
IMPLICATIONS FOR PRACTICE


Results from this study suggest that babywearing is a noninvasive and accessible intervention that can provide comfort for infants diagnosed with NAS. Babywearing can be inexpensive, support parenting, and be done by nonparent caregivers (eg, nurses, volunteers).
IMPLICATIONS FOR RESEARCH


Close physical contact, by way of babywearing, may improve outcomes in infants with NAS in NICUs and possibly reduce the need for pharmacological treatment.See the video abstract for a digital summary of the study.Video Abstract Available at: https://journals.lww.com/advancesinneonatalcare/pages/videogalleryaspx?autoPlay=false&videoId=38.",2020,"Across a 30-minute period, heart rates of infants worn by parents decreased by 15 beats per minute (bpm) compared with 5.5 bpm for infants worn by an unfamiliar adult, and those of adults decreased by 7 bpm (parents) and nearly 3 bpm (unfamiliar adult).
","['infants at risk for developing neonatal abstinence syndrome (NAS', 'infants and adults (parents vs other adults) in a neonatal intensive care unit (NICU) pre- ', 'infants with NAS in NICUs', 'Infants With Neonatal Abstinence Syndrome', 'infants diagnosed with NAS']","['Babywearing"" in the NICU']",['heart rates of infants worn by parents'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0027609', 'cui_str': 'Neonatal Abstinence Syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",,0.0543725,"Across a 30-minute period, heart rates of infants worn by parents decreased by 15 beats per minute (bpm) compared with 5.5 bpm for infants worn by an unfamiliar adult, and those of adults decreased by 7 bpm (parents) and nearly 3 bpm (unfamiliar adult).
","[{'ForeName': 'Lela Rankin', 'Initials': 'LR', 'LastName': 'Williams', 'Affiliation': 'School of Social Work Tucson, Arizona State University, Tucson (Dr Williams and Ms Gebler-Wolfe); Division of Neonatology, Department of Pediatrics, Banner University Medical Center Tucson, Tucson, Arizona (Ms Grisham and Dr Bader); and Division of Neonatology, Department of Pediatrics, University of Arizona, Tucson (Dr Bader).'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Gebler-Wolfe', 'Affiliation': ''}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Grisham', 'Affiliation': ''}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Bader', 'Affiliation': ''}]",Advances in neonatal care : official journal of the National Association of Neonatal Nurses,['10.1097/ANC.0000000000000788']
1956,33009629,"Etifoxine is non-inferior than clonazepam for reduction of anxiety symptoms in the treatment of anxiety disorders: a randomized, double blind, non-inferiority trial.","OBJECTIVE


To determine whether etifoxine, a non-benzodiazepine drug of the benzoxazine family, is non-inferior compared with clonazepam in the treatment of anxiety disorders.
METHOD


A randomized controlled double blind trial with parallel groups was conducted. A total of 179 volunteer patients with a diagnosis of anxiety disorder (DSM-IV), between 18 and 64 years of age, participated in this study. The experimental group received 150 mg/day of etifoxine and the control 1 mg/day of clonazepam, both in three daily doses for 12 weeks. This treatment was completed by 87 participants, and 70 were available for follow-up at 24 weeks from start of treatment. The primary objective was a non-inferiority comparison between etifoxine and clonazepam in the decrease of anxiety symptoms (HAM-A) at 12 weeks of treatment. Secondary outcomes included the evaluation of medication side effects (UKU), anxiety symptoms at 24 weeks of treatment, and clinical improvement (CGI). Data analysis included multiple imputation of missing data. The effect of etifoxine on the HAM-A, UKU, and CGI was evaluated with the intention of treatment, and a sensitivity analysis of the results was conducted. Non-inferiority would be declared by a standardized mean difference (SMD) between clonazepam and etifoxine not superior to 0.31 in favour of clonazepam.
RESULTS


Using imputed data, etifoxine shows non-inferiority to clonazepam on the reduction of anxiety symptoms at the 12-week (SMD = 0.407; 95% CI, 0.069, 0.746) and 24-week follow-ups (SMD = 0.484; 95% CI, 0.163, 0.806) and presented fewer side effects (SMD = 0.58; 95% CI, 0.287, 0.889). LOCF analysis shows that etifoxine is non-inferior to clonazepam on reduction of anxiety symptoms and adverse symptoms even when no change was assigned as result to participant whom withdrew. Non-inferiority could be declared for clinical improvement (SMD = 0.326; 95% CI, - 0.20, 0.858).
CONCLUSION


Etifoxine was non-inferior to clonazepam on reduction of anxiety symptoms, adverse effects, and clinical improvement.",2020,"LOCF analysis shows that etifoxine is non-inferior to clonazepam on reduction of anxiety symptoms and adverse symptoms even when no change was assigned as result to participant whom withdrew. Non-inferiority could be declared for clinical improvement (SMD = 0.326; 95% CI, - 0.20, 0.858).
","['anxiety disorders', '87 participants, and 70 were available for follow-up at 24\xa0weeks from start of treatment', '179 volunteer patients with a diagnosis of anxiety disorder (DSM-IV), between 18 and 64\xa0years of age, participated in this study']","['Etifoxine', 'etifoxine', 'etifoxine and clonazepam', '150\xa0mg/day of etifoxine and the control 1\xa0mg/day of clonazepam', 'clonazepam']","['anxiety symptoms', 'anxiety symptoms, adverse effects', 'anxiety symptoms and adverse symptoms', 'side effects', 'evaluation of medication side effects (UKU), anxiety symptoms at 24\xa0weeks of treatment, and clinical improvement (CGI', 'anxiety symptoms (HAM-A']","[{'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0059678', 'cui_str': 'etifoxine'}, {'cui': 'C0009011', 'cui_str': 'Clonazepam'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}]",179.0,0.324287,"LOCF analysis shows that etifoxine is non-inferior to clonazepam on reduction of anxiety symptoms and adverse symptoms even when no change was assigned as result to participant whom withdrew. Non-inferiority could be declared for clinical improvement (SMD = 0.326; 95% CI, - 0.20, 0.858).
","[{'ForeName': 'Benjamín', 'Initials': 'B', 'LastName': 'Vicente', 'Affiliation': 'Department of Psychiatry and Mental Health, Universidad de Concepción, Av. Juan Bosco s/n, Casilla 160-C, Concepción, Chile. bvicent@udec.cl.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Saldivia', 'Affiliation': 'Department of Psychiatry and Mental Health, Universidad de Concepción, Av. Juan Bosco s/n, Casilla 160-C, Concepción, Chile.'}, {'ForeName': 'Naín', 'Initials': 'N', 'LastName': 'Hormazabal', 'Affiliation': 'Ñuble Health Service, Bulnes 502, Chillán, Chile.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Bustos', 'Affiliation': 'Department of Psychiatry and Mental Health, Universidad de Concepción, Av. Juan Bosco s/n, Casilla 160-C, Concepción, Chile.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Rubí', 'Affiliation': 'Department of Psychiatry and Mental Health, Universidad de Concepción, Av. Juan Bosco s/n, Casilla 160-C, Concepción, Chile.'}]",Psychopharmacology,['10.1007/s00213-020-05617-6']
1957,33014902,Endoscopic Versus Microscopic Cartilage Myringoplasty in Chronic Otitis Media.,"Introduction


Operations on the tympanic membrane of the middle ear, myringoplasty, and tympanoplasty are now widely accepted, and attempts are underway all over the world to standardize the surgical techniques. This study aimed to compare postoperative outcomes of endoscopic and microscopic cartilage myringoplasty in patients suffering from chronic otitis media (COM).
Materials and Methods


This clinical trial study compared 130 patients with COM who underwent transcanal endoscopic myringoplasty by repairing perforation using auricular concha cartilage under general anesthesia (n=75) and conventional repairing method by postauricular incision and tympanomeatal flap elevation under microscopic surgery (n=55).
Results


According to the results, there was no significant difference between the two groups in terms of hearing gain 1, 6, and 12 months after surgery (P=0.063); however, higher hearing gain scores were observed in the endoscopic group. Moreover, lower recovery time and post-operative pain were reported in patients who underwent the endoscopic approach, compared to those who treated with the conventional repairing method (P<0.001).
Conclusion


Endoscopic myringoplasty technique is a safe and effective way to improve hearing loss as much as the conventional method. However, due to the lower recovery time and post-operative pain, it seems to be the method of choice in myringoplasty surgery.",2020,"According to the results, there was no significant difference between the two groups in terms of hearing gain 1, 6, and 12 months after surgery (P=0.063); however, higher hearing gain scores were observed in the endoscopic group.","['n=55', 'Chronic Otitis Media', '130 patients with COM who underwent', 'patients suffering from chronic otitis media (COM']","['transcanal endoscopic myringoplasty by repairing perforation using auricular concha cartilage under general anesthesia (n=75) and conventional repairing method by postauricular incision and tympanomeatal flap elevation under microscopic surgery', 'endoscopic and microscopic cartilage myringoplasty', 'Endoscopic\xa0Versus\xa0Microscopic Cartilage']","['hearing loss', 'hearing gain scores', 'hearing gain', 'lower recovery time and post-operative pain']","[{'cui': 'C0271441', 'cui_str': 'Chronic otitis media'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0229316', 'cui_str': 'Concha of ear structure'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0457827', 'cui_str': 'Postauricular incision'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",130.0,0.020769,"According to the results, there was no significant difference between the two groups in terms of hearing gain 1, 6, and 12 months after surgery (P=0.063); however, higher hearing gain scores were observed in the endoscopic group.","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Daneshi', 'Affiliation': 'ENT and Head & Neck Research Center , The\xa0 Five Senses Health Institute , Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Daneshvar', 'Affiliation': 'ENT and Head & Neck Research Center , The\xa0 Five Senses Health Institute , Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alimohamad', 'Initials': 'A', 'LastName': 'Asghari', 'Affiliation': 'Skull Base Research Center , The\xa0 Five Senses Health Institute , Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Farhadi', 'Affiliation': 'ENT and Head & Neck Research Center , The\xa0 Five Senses Health Institute , Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Mohebbi', 'Affiliation': 'ENT and Head & Neck Research Center , The\xa0 Five Senses Health Institute , Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Mohseni', 'Affiliation': 'ENT and Head & Neck Research Center , The\xa0 Five Senses Health Institute , Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Yazdani', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Amir Alam Hospital, Tehran, Iran.'}, {'ForeName': 'Shabahang', 'Initials': 'S', 'LastName': 'Mohammadi', 'Affiliation': 'ENT and Head & Neck Research Center , The\xa0 Five Senses Health Institute , Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Hosseinzadeh', 'Affiliation': 'ENT and Head & Neck Research Center , The\xa0 Five Senses Health Institute , Iran University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of otorhinolaryngology,['10.22038/ijorl.2020.44015.2453']
1958,33014907,Cryosurgery Vs Trichloroacetic Acid Chemical Cautery for the Treatment of Hypertrophied Nasal Turbinate: A Comparative Study.,"Introduction


The Study Aimed To Compare The Results of Cryosurgery With Trichloroacetic Acid Chemical (TCA) Cautery For The Treatment of Hypertrophied Nasal Turbinates.
Materials and Methods


This was a prospective study of 70 patients with nasal obstruction due to hypertrophied nasal turbinates who were randomly divided in 2 groups of 35 each. In group 1, patients underwent inferior nasal turbinate reduction by cryosurgery and in group 2 patients with cautery by 50 % TCA. The patients were evaluated using SNOT-20 score pre and postoperatively on 6th month.
Results


Significant improvement in symptoms was seen in 28 patients (80 %) in group 1 and in 10 patients (28.57%) in group 2..Improvement in average SNOT Score after cauterization of hypertrophied nasal turbinates by cryosurgery was from 55(severe) to 16(mild) and by TCA was from 54(severe) to 32(mod) in 6 months and this was statistically significant (P<0.001). Complications like bleeding, scarring, infection and adhesion formation were more with TCA than that of cryosurgery group and among these complications scarring was statistically significant (P =0.003).
Conclusion


The use of cryosurgical treatment for hypertrophied nasal turbinates is a safe, curative method as compared to that of TCA cautery which is less curative and with more complications.",2020,"Complications like bleeding, scarring, infection and adhesion formation were more with TCA than that of cryosurgery group and among these complications scarring was statistically significant (P =0.003).
","['Hypertrophied Nasal Turbinate', '70 patients with nasal obstruction due to hypertrophied nasal turbinates who were randomly divided in 2 groups of 35 each']","['TCA cautery', 'Trichloroacetic Acid Chemical (TCA) Cautery', 'Cryosurgery Vs Trichloroacetic Acid Chemical Cautery', 'TCA', 'cautery by 50 % TCA']","['symptoms', 'Complications like bleeding, scarring, infection and adhesion formation', 'complications scarring', 'average SNOT Score']","[{'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C1266928', 'cui_str': 'Nasal turbinate bone structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0155840', 'cui_str': 'Hypertrophy of nasal turbinates'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040900', 'cui_str': 'Trichloroacetic acid'}, {'cui': 'C0441495', 'cui_str': 'Chemocautery - action'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0007471', 'cui_str': 'Cauterization - action'}, {'cui': 'C0010408', 'cui_str': 'Cryosurgery'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",70.0,0.0194224,"Complications like bleeding, scarring, infection and adhesion formation were more with TCA than that of cryosurgery group and among these complications scarring was statistically significant (P =0.003).
","[{'ForeName': 'Satish S', 'Initials': 'SS', 'LastName': 'Satpute', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India.'}, {'ForeName': 'Samir V', 'Initials': 'SV', 'LastName': 'Joshi', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, BJ Government Medical College, Pune, India.'}, {'ForeName': 'Ripudaman', 'Initials': 'R', 'LastName': 'Arora', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India.'}, {'ForeName': 'Neel', 'Initials': 'N', 'LastName': 'Prabha', 'Affiliation': 'Department of Dermatology, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Keche', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, SVN Govt Medical College, Yavatmal, India.'}, {'ForeName': 'Nitin M', 'Initials': 'NM', 'LastName': 'Nagarkar', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India.'}]",Iranian journal of otorhinolaryngology,['10.22038/ijorl.2019.39039.2293']
1959,33016570,Explantation Rates of High Frequency Spinal Cord Stimulation in Two Outpatient Clinics.,"OBJECTIVES


To report the explantation rates of high frequency 10 kHz spinal cord stimulation (SCS) in a real-world setting.
MATERIALS AND METHODS


This is a retrospective review of patients implanted with high frequency spinal cord stimulators over a 4-year period in two outpatient private practice clinics, from July 2015 through June 2019, using the Kaplan-Meier product-limit method to estimate probabilities of implant survival over time.
RESULTS


The estimated median time to explantation was 3.5 years (95% confidence interval [CI] = 3.1-3.7) [Correction added on 15 October 2020, after first online publication: The preceeding sentence was amended to reflect the estimated median time.]. The estimated probabilities of implant survival beyond 1, 2, and 3 years postimplantation were 88.4% (95% CI = 81.3-93.0%), 76.5% (95% CI = 67.8-83.2%), and 60.7% (95% CI = 50.2-69.6%), respectively. The minimum (i.e., known) cumulative percentages of patients explanted by 1, 2, and 3 years postimplantation were 11.1% (14/126), 22.2% (28/126), and 32.5% (41/126), respectively. 65.9% of patients in this study had prior neurostimulation.
CONCLUSIONS


Recently, high frequency SCS technology has been demonstrated as more effective in treatment of lower- and leg-pain, compared to conventional low frequency SCS, in a 12-month randomized controlled trial (SENZA-RCT). Longer term results have yet to be published. In this study, we found that the explantation rate was much higher than expected, based on the prior studies demonstrating its efficacy. As the use of neuromodulation continues to grow, longitudinal data will be critical in understanding its long-term effects on treated patients.",2020,"The estimated probabilities of implant survival beyond 1, 2, and 3 years postimplantation were 88.4% (95% CI = 81.3-93.0%), 76.5% (95% CI = 67.8-83.2%), and 60.7% (95% CI = 50.2-69.6%), respectively.","['Two Outpatient Clinics', 'patients implanted with high frequency spinal cord stimulators over a 4-year period in two outpatient private practice clinics, from July 2015 through June 2019']",['kHz spinal cord stimulation (SCS'],"['estimated probabilities of implant survival', 'explantation rate', 'median time to explantation']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}]","[{'cui': 'C0556965', 'cui_str': 'kHz'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0561946', 'cui_str': 'Removal of implant'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.120114,"The estimated probabilities of implant survival beyond 1, 2, and 3 years postimplantation were 88.4% (95% CI = 81.3-93.0%), 76.5% (95% CI = 67.8-83.2%), and 60.7% (95% CI = 50.2-69.6%), respectively.","[{'ForeName': 'Victor C', 'Initials': 'VC', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology Perioperative and Pain Medicine, Newport Beach Headache and Pain, Coast Pain Management, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Vickie', 'Initials': 'V', 'LastName': 'Bounkousohn', 'Affiliation': ""Department of Anesthesiology Perioperative and Pain Medicine, Newport Beach Headache and Pain, Coast Pain Management, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Fields', 'Affiliation': ""Department of Anesthesiology Perioperative and Pain Medicine, Newport Beach Headache and Pain, Coast Pain Management, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Bernstein', 'Affiliation': ""Department of Anesthesiology Perioperative and Pain Medicine, Newport Beach Headache and Pain, Coast Pain Management, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Paicius', 'Affiliation': ""Department of Anesthesiology Perioperative and Pain Medicine, Newport Beach Headache and Pain, Coast Pain Management, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gilligan', 'Affiliation': ""Department of Anesthesiology Perioperative and Pain Medicine, Newport Beach Headache and Pain, Coast Pain Management, Brigham and Women's Hospital, Boston, MA, USA.""}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13280']
1960,33025835,Parent-Focused Sexual Abuse Prevention: Results From a Cluster Randomized Trial.,"This study tested whether a child sexual abuse (CSA) prevention program, Smart Parents-Safe and Healthy Kids (SPSHK), could be implemented as an additional module in evidence-based parent training and whether the added module might detract from the efficacy of the original program. In a cluster randomized trial, six community-based organizations were randomized to deliver Parents as Teachers (PAT) with SPSHK (PAT+SPSHK) or PAT as usual (PAT-AU). CSA-related awareness and protective behaviors, as well as general parenting behaviors taught by PAT were assessed at baseline, post-PAT, post-SPSHK, and 1-month follow-up. Multilevel analyses revealed significant group by time interactions for both awareness and behaviors ( ps <  .0001), indicating the PAT+SPSHK group had significantly greater awareness of CSA and used protective behaviors more often (which were maintained at follow-up) compared to the PAT-AU group. No differences were observed in general parenting behaviors taught by PAT suggesting adding SPHSK did not interfere with PAT efficacy as originally designed. Results indicate adding SPHSK to existing parent training can significantly enhance parents' awareness of and readiness to engage in protective behavioral strategies. Implementing SPHSK as a selective prevention strategy with at-risk parents receiving parent training through child welfare infrastructures is discussed.",2020,No differences were observed in general parenting behaviors taught by PAT suggesting adding SPHSK did not interfere with PAT efficacy as originally designed.,"['child sexual abuse (CSA) prevention program, Smart Parents-Safe and Healthy Kids (SPSHK']","['Parents as Teachers (PAT) with SPSHK (PAT+SPSHK) or PAT', 'PAT+SPSHK']","['CSA-related awareness and protective behaviors', 'awareness of CSA and used protective behaviors']","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",6.0,0.0313322,No differences were observed in general parenting behaviors taught by PAT suggesting adding SPHSK did not interfere with PAT efficacy as originally designed.,"[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Guastaferro', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Felt', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Font', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Christian M', 'Initials': 'CM', 'LastName': 'Connell', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Sheridan', 'Initials': 'S', 'LastName': 'Miyamoto', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Zadzora', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Jennie G', 'Initials': 'JG', 'LastName': 'Noll', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}]",Child maltreatment,['10.1177/1077559520963870']
1961,33025883,"Effect of caffeinated and decaffeinated coffee on serum uric acid and uric acid clearance, a randomised within-subject experimental study.","OBJECTIVES


The effect of coffee on serum uric acid (SUA) has shown conflicting results. This study was to determine the effects of caffeinated coffee (CC) and decaffeinated coffee (DC) on SUA, serum xanthine oxidase activity (sXOA) and urine uric acid clearance (UAC).
METHODS


This was a prospective randomised within-subject experimental study design of 51 healthy male participants. Each study period consisted of 3 periods, including a control, an intervention, and washout period for 1, 3 and 1 week, respectively. During the intervention period, the participants received 2, 4 or 6 gram/day of coffee, either CC or DC.
RESULTS


For DC groups, SUA significantly decreased by 6.5 (±1.1) mg/dL to 6.2 (±1.1) mg/dL during the intervention period (p=0.014). sXOA significantly increased by 0.05 (±0.07) nmol/min/mL to 0.20 (±0.38) nmol/min/mL during the intervention period (p=0.010) of CC. For UAC, there was no significant change with CC or DC. In hyperuricaemic participants, SUA significantly decreased by 7.7 (±0.7) mg/dL to 7.2 (±0.7) mg/dL during the intervention period (p=0.028) of DC. For non-hyperuricaemic, CC significantly increased SUA by 5.9 (±0.7) mg/dL to 6.2 (±0.9) mg/dL during the intervention period (p=0.008) and significantly decreased SUA to 6.0 (±0.8) mg/dL (p=0.049) during the withdrawal period. A significant increase of sXOA according with SUA in CC groups from 0.05 (±0.07) nmol/min/mL to 0.25 (±0.44) nmol/min/mL during the intervention period (p=0.040) was presented in non-hyperuricaemic participants.
CONCLUSIONS


DC had a significant decrease of SUA during the intervention period. However, in non-HUS participants, SUA significantly increased in CC.",2020,"For non-hyperuricaemic, CC significantly increased SUA by 5.9 (±0.7) mg/dL to 6.2 (±0.9) mg/dL during the intervention period (p=0.008) and significantly decreased SUA to 6.0 (±0.8) mg/dL (p=0.049) during the withdrawal period.",['51 healthy male participants'],"['caffeinated and decaffeinated coffee', 'caffeinated coffee (CC) and decaffeinated coffee (DC']","['sXOA', 'SUA, serum xanthine oxidase activity (sXOA) and urine uric acid clearance (UAC', 'SUA', 'serum uric acid and uric acid clearance']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0009237', 'cui_str': 'Coffee'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0043317', 'cui_str': 'Xanthine oxidase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0428286', 'cui_str': 'Urine urate measurement'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}]",51.0,0.0143496,"For non-hyperuricaemic, CC significantly increased SUA by 5.9 (±0.7) mg/dL to 6.2 (±0.9) mg/dL during the intervention period (p=0.008) and significantly decreased SUA to 6.0 (±0.8) mg/dL (p=0.049) during the withdrawal period.","[{'ForeName': 'Patapong', 'Initials': 'P', 'LastName': 'Towiwat', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Naresuan University, Thailand. puidulian@gmail.com.'}, {'ForeName': 'Anothai', 'Initials': 'A', 'LastName': 'Tangsumranjit', 'Affiliation': 'Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Naresuan University, Thailand.'}, {'ForeName': 'Kornkanok', 'Initials': 'K', 'LastName': 'Ingkaninan', 'Affiliation': 'Department of Pharmaceutical Chemistry and Pharmacognosy, Faculty of Pharmaceutical Sciences, Naresuan University, Thailand.'}, {'ForeName': 'Katechan', 'Initials': 'K', 'LastName': 'Jampachaisri', 'Affiliation': 'Department of Mathematics, Faculty of Science, Naresuan University, Thailand.'}, {'ForeName': 'Nattiya', 'Initials': 'N', 'LastName': 'Chaichamnong', 'Affiliation': 'Department of Applied Thai Traditional Medicine, Faculty of Public Health, Naresuan University, Thailand.'}, {'ForeName': 'Bodin', 'Initials': 'B', 'LastName': 'Buttham', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Naresuan University, Thailand.'}, {'ForeName': 'Worawit', 'Initials': 'W', 'LastName': 'Louthrenoo', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Thailand.'}]",Clinical and experimental rheumatology,[]
1962,33002731,Gamma-transcranial alternating current stimulation and theta-burst stimulation: inter-subject variability and the role of BDNF.,"OBJECTIVE


The main limitation of neuromodulation techniques is inter-subject variability. Combining theta-burst stimulation (TBS) with gamma-transcranial alternating current stimulation (γ-tACS) allows to shape cortical plasticity. However, it is unknown whether γ-tACS modifies TBS-induced response variability. In this study, we measured the inter-subject variability of TBS-γ tACS and controlled the effect of the Brain-Derived Neurotrophic Factor (BDNF) Val66Met polymorphism.
METHODS


Intermittent TBS (iTBS)-sham tACS, iTBS-γ tACS, continuous TBS (cTBS)-sham tACS, and cTBS-γ tACS were applied in randomised sessions. Inter-subject variability was measured using grand average and clustering methods. TBS-γ tACS effects on motor evoked potentials (MEP) were compared between Val/Val and Met carriers.
RESULTS


We found that γ-tACS boosted iTBS-induced MEP facilitation and cancelled cTBS-induced MEP depression. Grand average analysis showed that γ-tACS prominently increased the percentage of iTBS responders and cTBS non-responders. The clustering method demonstrated that TBS-γ tACS response varied between subjects, a phenomenon unrelated to the BDNF genotype.
CONCLUSIONS


Enhancing γ oscillations through tACS boosts iTBS-induced LTP-like plasticity and suppresses cTBS-induced LTD-like plasticity of the primary motor cortex in a reliable manner. The BDNF Val66Met polymorphism does not influence these effects.
SIGNIFICANCE


Since γ-tACS significantly increases the number of iTBS responders, it may be used in clinical settings.",2020,Grand average analysis showed that γ-tACS prominently increased the percentage of iTBS responders and cTBS non-responders.,[],"['Gamma-transcranial alternating current stimulation and theta-burst stimulation', 'γ-tACS', 'TBS-γ tACS', 'Combining theta-burst stimulation (TBS) with gamma-transcranial alternating current stimulation (γ-tACS', 'TBS (iTBS)-sham tACS, iTBS-γ tACS, continuous TBS (cTBS)-sham tACS, and cTBS-γ tACS']","['motor evoked potentials (MEP', 'TBS-γ tACS response', 'percentage of iTBS responders']",[],"[{'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}]",,0.0513527,Grand average analysis showed that γ-tACS prominently increased the percentage of iTBS responders and cTBS non-responders.,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Guerra', 'Affiliation': 'IRCCS Neuromed, Via Atinense 18, 86077 Pozzilli, IS, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Asci', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Zampogna', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': ""D'Onofrio"", 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy.""}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Petrucci', 'Affiliation': ""Department of Clinical and Molecular Medicine, Sapienza University of Rome, Rome, Italy; Sant'Andrea University Hospital, Rome, Italy.""}, {'ForeName': 'Monia', 'Initials': 'M', 'LastName': 'Ginevrino', 'Affiliation': 'Istituto di Medicina Genomica, Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Rome, Italy; Laboratory of Medical Genetics, Bambino Gesù Children\'s Hospital, Rome, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Berardelli', 'Affiliation': ""IRCCS Neuromed, Via Atinense 18, 86077 Pozzilli, IS, Italy; Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy. Electronic address: alfredo.berardelli@uniroma1.it.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Suppa', 'Affiliation': ""IRCCS Neuromed, Via Atinense 18, 86077 Pozzilli, IS, Italy; Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy.""}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.08.017']
1963,33002745,Comparison of the effectiveness of the virtual simulator and video-assisted teaching on intravenous catheter insertion skills and self-confidence: A quasi-experimental study.,"BACKGROUND


With the advancement of technology, methods such as clinical scenarios, role playing, video demonstration and simulation are now used to develop psychomotor skills in nursing education. Virtual reality and video-assisted teaching are useful technologies for the development of skills and self-confidence. In the literature, there is a lack of studies comparing the effects of the two methods.
OBJECTIVES


The aim of study is to compare the effect of the virtual simulator and video assisted teaching on the level of intravenous catheterization skills and self-confidence of nursing students. Thus, students are enabled to develop skills and work efficiently without the need for an instructor.
METHODS


This study was a randomized controlled quasi-experimental study. A total of 60 students was included in the study (30 in the virtual simulator group and 30 in the video group). In the virtual simulator group, each student performed an intravenous catheter insertion in the virtual intravenous simulator. In the video group, each student watched a training video on the peripheral intravenous catheterization skill in a classroom setting. Each of the students' level of intravenous catheterization knowledge, psychomotor skill and self-confidence score was evaluated.
RESULTS


Post-test knowledge scores was higher than pretest knowledge scores for both groups. There were no significant difference between the groups in terms of post-test scores. Students' scores of psychomotor skills were found to be higher in the virtual simulator group and self-confidence scores were similar in both groups.
CONCLUSION


Teaching with the virtual simulator contributed to the students' skills more than the method used in the video training. Both methods are effective in the development of knowledge and self-confidence related to intravenous catheterization.",2020,"Students' scores of psychomotor skills were found to be higher in the virtual simulator group and self-confidence scores were similar in both groups.
","['60 students was included in the study (30 in the virtual simulator group and 30 in the video group', 'nursing students']","['Virtual reality and video-assisted teaching', 'virtual simulator and video assisted teaching', 'virtual simulator and video-assisted teaching']","[""Students' scores of psychomotor skills"", 'self-confidence scores', 'intravenous catheterization knowledge, psychomotor skill and self-confidence score']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",60.0,0.0559607,"Students' scores of psychomotor skills were found to be higher in the virtual simulator group and self-confidence scores were similar in both groups.
","[{'ForeName': 'Elif Günay', 'Initials': 'EG', 'LastName': 'İsmailoğlu', 'Affiliation': 'Izmir Bakircay University, İzmir, Turkey. Electronic address: elif.ismailoglu@bakircay.edu.tr.'}, {'ForeName': 'Nilay', 'Initials': 'N', 'LastName': 'Orkun', 'Affiliation': 'Ege University, İzmir, Turkey.'}, {'ForeName': 'İsmet', 'Initials': 'İ', 'LastName': 'Eşer', 'Affiliation': 'Ege University, İzmir, Turkey.'}, {'ForeName': 'Ayten', 'Initials': 'A', 'LastName': 'Zaybak', 'Affiliation': 'Ege University, İzmir, Turkey.'}]",Nurse education today,['10.1016/j.nedt.2020.104596']
1964,33002752,A comparison of ultrasound-guided rotator interval and posterior glenohumeral injection techniques for MR shoulder arthrography.,"PURPOSE


The aim of this prospective, randomized study was to compare the performance of a rotator interval approach with the posterior glenohumeral approach for ultrasound-guided contrast injection prior to MR shoulder arthrography.
METHOD


This study was approved by the institutional review board. One hundred and twenty consecutive patients referred for MR shoulder arthrography were randomized into four groups: rotator interval approach in-plane (n = 30); rotator interval approach out-of-plane (n = 30); posterior approach in-plane (n = 30); and posterior approach out-of plane (n = 30). Outcome measures included procedure time, number of injection attempts, patient-reported pain score (0-10), and radiologist-reported technical difficulty (0-10). MR arthrograms were assessed for adequacy of joint distension, diagnostic utility, and extra-capsular contrast leakage.
RESULTS


All 120 patients had a successful ultrasound-guided injection with adequate joint distension and diagnostic utility for MR arthrography. In-plane needle guidance was less technically demanding, quicker, required fewer injection attempts, and had a lower frequency of contrast leakage than out-of-plane needle guidance. The posterior glenohumeral approach was less technically demanding though had a higher frequency of contrast leakage and caused more patient discomfort than the rotator interval approach.
CONCLUSION


For ultrasound-guided shoulder joint injection, an in-plane approach is preferable. The posterior glenohumeral approach is less technically demanding though causes more patients discomfort than the rotator interval approach possibly due to the longer needle path.",2020,"In-plane needle guidance was less technically demanding, quicker, required fewer injection attempts, and had a lower frequency of contrast leakage than out-of-plane needle guidance.","['One hundred and twenty consecutive patients referred for MR shoulder arthrography', 'MR shoulder arthrography', 'All 120 patients had a successful ultrasound-guided injection with adequate joint distension and diagnostic utility for MR arthrography']","['posterior glenohumeral approach for ultrasound-guided contrast injection', 'ultrasound-guided rotator interval and posterior glenohumeral injection techniques', 'rotator interval approach in-plane (n\xa0=\xa030); rotator interval approach out-of-plane (n\xa0=\xa030); posterior approach in-plane (n\xa0=\xa030); and posterior approach out-of plane']","['procedure time, number of injection attempts, patient-reported pain score (0-10), and radiologist-reported technical difficulty (0-10', 'patient discomfort', 'adequacy of joint distension, diagnostic utility, and extra-capsular contrast leakage']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0203224', 'cui_str': 'Arthrography of shoulder'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0003885', 'cui_str': 'Arthrography'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}, {'cui': 'C0282419', 'cui_str': 'Technical Report'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]",120.0,0.0381212,"In-plane needle guidance was less technically demanding, quicker, required fewer injection attempts, and had a lower frequency of contrast leakage than out-of-plane needle guidance.","[{'ForeName': 'Carita', 'Initials': 'C', 'LastName': 'Tsoi', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Chris S C', 'Initials': 'CSC', 'LastName': 'Tsai', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Eric K C', 'Initials': 'EKC', 'LastName': 'Law', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ryan K L', 'Initials': 'RKL', 'LastName': 'Lee', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Alex W H', 'Initials': 'AWH', 'LastName': 'Ng', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Griffith', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong. Electronic address: griffith@cuhk.edu.hk.'}]",Clinical imaging,['10.1016/j.clinimag.2020.08.031']
1965,33002791,Results of a Pilot Trial of a Lifestyle Intervention for Stroke Survivors: Healthy Eating and Lifestyle after Stroke.,"OBJECTIVES


Although healthy lifestyle practices mitigate recurrent stroke risk and mortality, few stroke survivors adhere to them, particularly among socioeconomically disadvantaged communities. We developed and pilot tested a occupational therapy-based lifestyle management intervention, Healthy Eating And Lifestyle after Stroke (HEALS), to improve stroke survivors' self-management skills relating to diet and physical activity and evaluated it in a diverse safety-net population.
MATERIALS AND METHODS


One hundred English- or Spanish-speaking participants with stroke or transient ischemic attack were randomized to a 6-week occupational therapist-led group lifestyle intervention vs. usual care. Each of the six 2-h group sessions included didactic presentations on diet and physical activity, peer exchange, personal exploration with goal setting, and direct experience through participation in a relevant activity. Primary outcomes at 6 months were change in body mass index, fruit/vegetable intake, and physical activity. Secondary outcomes included change in waist circumference, smoking, blood pressure, high-density lipoprotein, low-density lipoprotein, triglyceride, total cholesterol, glycosylated hemoglobin levels, quality of care, and perceptions of care. Effect sizes were determined in preparation for a larger randomized controlled trial powered to detect a difference in primary outcomes. A nested formative evaluation assessed facilitators and barriers to implementation, acceptance, and intervention adherence.
RESULTS


There were no significant changes in primary or secondary outcomes at 6 months. Effect sizes for all outcomes were small (< 0.2). Focus group participants recommended extending the intervention program duration with more sessions, additional information on stroke and vascular risk factors, an interdisciplinary approach, additional family involvement, and incentives. Providers recommended longer program duration, more training, fidelity checks to ensure standardized program delivery, and additional incentives for participants.
CONCLUSIONS


The HEALS intervention was feasible in a safety-net setting, but effect sizes were small. A longer-duration intervention, with intervener fidelity checks may be warranted.
TRIAL REGISTRATION


NCT01550822.",2020,There were no significant changes in primary or secondary outcomes at 6 months.,"['One hundred English- or Spanish-speaking participants with stroke or transient ischemic attack', 'Stroke Survivors', 'Healthy Eating and Lifestyle after Stroke']","['HEALS intervention', 'occupational therapist-led group lifestyle intervention vs. usual care', 'intervention program duration with more sessions, additional information on stroke and vascular risk factors, an interdisciplinary approach, additional family involvement, and incentives', 'didactic presentations on diet and physical activity, peer exchange, personal exploration with goal setting, and direct experience through participation in a relevant activity', 'occupational therapy-based lifestyle management intervention, Healthy Eating And Lifestyle after Stroke (HEALS', 'Lifestyle Intervention']","['change in waist circumference, smoking, blood pressure, high-density lipoprotein, low-density lipoprotein, triglyceride, total cholesterol, glycosylated hemoglobin levels, quality of care, and perceptions of care', 'change in body mass index, fruit/vegetable intake, and physical activity']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.121269,There were no significant changes in primary or secondary outcomes at 6 months.,"[{'ForeName': 'Amytis', 'Initials': 'A', 'LastName': 'Towfighi', 'Affiliation': 'Los Angeles County + University of Southern California Medical Center, 1100 N State St, A4E, Los Angeles, CA 90033, United States; Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States; Los Angeles County Department of Health Services, Los Angeles, CA, United States. Electronic address: towfighi@usc.edu.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Cheng', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Hill', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States; University of Cincinnati, Cincinnati, OH, United States.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Barry', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Natalie P', 'Initials': 'NP', 'LastName': 'Valle', 'Affiliation': 'St Jude Medical Center, Fullerton, CA, United States. Electronic address: Natalie.valle@stjoe.org.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mittman', 'Affiliation': 'Kaiser Permanente, Los Angeles, CA, United States.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ayala-Rivera', 'Affiliation': 'Los Angeles County + University of Southern California Medical Center, 1100 N State St, A4E, Los Angeles, CA 90033, United States.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Moreno', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Annaliese', 'Initials': 'A', 'LastName': 'Espinosa', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Dombish', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Ochoa', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Chu', 'Affiliation': 'Los Angeles County + University of Southern California Medical Center, 1100 N State St, A4E, Los Angeles, CA 90033, United States. Electronic address: chu381@usc.edu.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Atkins', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Barbara G', 'Initials': 'BG', 'LastName': 'Vickrey', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105323']
1966,33006195,"Patient-Administered Transcutaneous Electrical Nerve Stimulation for Postoperative Pain Control After Laparoscopic Cholecystectomy: A Randomized, Sham-Controlled Feasibility Trial.","OBJECTIVES


Transcutaneous electrical nerve stimulation (TENS) is a noninvasive analgesic neurostimulation modality. Difficulties in clinical trial blinding and therapy administration have limited conclusions of previous trials. The aims of this study were to first investigate the feasibility and acceptability of patient-administered TENS after surgery, and second, the feasibility of using sub-sensory TENS as a proxy sham group for patient-blinding.
MATERIALS AND METHODS


Over a four-month period, patients undergoing laparoscopic cholecystectomy at a single center were randomized to receive maximally tolerable high-intensity (HI) TENS or sub-sensory low-intensity (LI) TENS. Patients and outcome assessors were blinded. Primary outcomes were the feasibility, tolerability, and acceptability of patient self-administered TENS, measured by patient-reported outcomes, and the strength of patient-blinding, measured using the James Blinding Index (JBI). Secondary outcomes explored clinical recovery and analgesic efficacy.
RESULTS


Nineteen patients were screened for inclusion; ten patients were randomized and completed the feasibility study. TENS therapy was variably utilized (median duration of TENS 5.3 hours/day [IQR: 4.1-6.9]). The JBI was 0.7, indicating a strong strength of blinding. Majority of patients found the TENS unit easy to use (90%) and were confident with self-administration (100%). No patients experienced adverse effects of TENS use.
CONCLUSIONS


Patient-administered TENS is safe and acceptable. Future studies may use sub-sensory TENS as a proxy sham control to more reliably blind patients. A larger, double-blinded RCT employing these techniques is now needed to determine the analgesic efficacy of TENS in an enhanced recovery setting, and its potential to reduce opiate usage.",2020,"Primary outcomes were the feasibility, tolerability, and acceptability of patient self-administered TENS, measured by patient-reported outcomes, and the strength of patient-blinding, measured using the James Blinding Index (JBI).","['Nineteen patients were screened for inclusion; ten patients', 'patients undergoing laparoscopic cholecystectomy at a single center']","['maximally tolerable high-intensity (HI) TENS or sub-sensory low-intensity (LI) TENS', 'patient-administered TENS', 'Transcutaneous Electrical Nerve Stimulation', 'Transcutaneous electrical nerve stimulation (TENS', 'Laparoscopic Cholecystectomy', 'TENS']","['Postoperative Pain Control', 'feasibility, tolerability, and acceptability of patient self-administered TENS, measured by patient-reported outcomes, and the strength of patient-blinding, measured using the James Blinding Index (JBI', 'feasibility and acceptability', 'clinical recovery and analgesic efficacy']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",19.0,0.196764,"Primary outcomes were the feasibility, tolerability, and acceptability of patient self-administered TENS, measured by patient-reported outcomes, and the strength of patient-blinding, measured using the James Blinding Index (JBI).","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Surgery, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Varghese', 'Affiliation': 'Department of Surgery, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Cameron I', 'Initials': 'CI', 'LastName': 'Wells', 'Affiliation': 'Department of Surgery, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Ian P', 'Initials': 'IP', 'LastName': 'Bissett', 'Affiliation': 'Department of Surgery, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': ""O'Grady"", 'Affiliation': 'Department of Surgery, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13242']
1967,33007353,Effect of patiromer on serum potassium in hyperkalemic patients with heart failure: Pooled analysis of 3 randomized trials.,"BACKGROUND


Hyperkalemia (HK) is a serious medical condition that can cause potentially fatal cardiac arrhythmias. Patients with heart failure (HF) are at risk of HK due to underlying chronic kidney disease and use of guideline-recommended renin-angiotensin-aldosterone system inhibitors. Patiromer, a sodium-free, non-absorbed potassium (K + ) binder, is indicated for the treatment of HK.
OBJECTIVE


To evaluate the consistency of patiromer's effect on lowering serum K +  in patients with HF and HK using pooled data from three clinical trials.
METHODS


This post-hoc analysis evaluated the efficacy and safety of patiromer for management of HK over a 4-week treatment period using combined data from three clinical trials (AMETHYST-DN, OPAL-HK and TOURMALINE). Eligible patients had HK (serum K +  > 5.0 mEq/L) at study entry. Starting doses of patiromer ranged from 8.4 to 33.6 g/day. In this analysis, efficacy was assessed as the mean (± standard error [SE]) change in serum K +  from baseline to Week 4. Safety outcomes evaluated included the incidence and severity of adverse events (AEs) during the 4-week treatment period.
RESULTS


In total, 653 patients who received ≥1 dose of patiromer were evaluable for efficacy (214 diagnosed with HF and 439 without HF). Mean baseline serum K +  was 5.4 mEq/L. Patient characteristics were generally similar between the HF and non-HF subgroups. Serum K +  decreased to <5.0mEq/L within one week of patients starting patiromer, reaching a nadir after 3 weeks in both the HF and non-HF subgroups (4.59 mEq/L and 4.64 mEq/L, respectively). The mean ± SE change from baseline to Week 4 in serum K +  was -0.79 ± 0.06 mEq/L (95% CI: -0.91, -0.68) in patients with HF and - 0.75 ± 0.02 mEq/L (95% CI: -0.79, -0.70) in patients without HF. AEs occurred in 31% of patients with HF and 37% of patients without HF and were mostly mild or moderate in severity. The most common AEs were constipation (HF patients: 7%, non-HF patients: 5%) and diarrhea (HF patients: 2%, non-HF patients: 4%). AEs leading to discontinuation of patiromer occurred in 7% of patients with HF and in 3% of patients without HF.
CONCLUSIONS


In this pooled analysis of patients with HK, patiromer was generally well tolerated and reduced serum K +  similarly in patients with and without HF over 4 weeks.",2020,"The most common AEs were constipation (HF patients: 7%, non-HF patients: 5%) and diarrhea (HF patients: 2%, non-HF patients: 4%).","['hyperkalemic patients with heart failure', 'patients with HF and HK using pooled data from three clinical trials', 'Eligible patients had HK (serum K + \u202f>\u202f5.0\u202fmEq/L) at study entry', '653 patients who received ≥1 dose of patiromer were evaluable for efficacy (214 diagnosed with HF and 439 without HF', 'Patients with heart failure (HF']","['sodium-free, non-absorbed potassium (K + ) binder', 'patiromer']","['diarrhea', 'tolerated and reduced serum K ', 'AEs leading to discontinuation of patiromer', 'efficacy and safety', 'mean (± standard error [SE]) change in serum K ', 'incidence and severity of adverse events (AEs', 'mean\u202f±\u202fSE change', 'Mean baseline serum K ', 'serum potassium', 'AEs', 'Serum K ', 'constipation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0439375', 'cui_str': 'mEq/L'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4045522', 'cui_str': 'patiromer'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C4045522', 'cui_str': 'patiromer'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C4045522', 'cui_str': 'patiromer'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",653.0,0.0593979,"The most common AEs were constipation (HF patients: 7%, non-HF patients: 5%) and diarrhea (HF patients: 2%, non-HF patients: 4%).","[{'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Wayne State University, Detroit, MI, USA. Electronic address: ilppina@aol.com.'}, {'ForeName': 'Jinwei', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Relypsa, Inc., a Vifor Pharma Company, Redwood City, CA, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Ackourey', 'Affiliation': 'Relypsa, Inc., a Vifor Pharma Company, Redwood City, CA, USA.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Ventura', 'Affiliation': 'Department of Cardiology, Cardiomyopathy and Heart Transplantation Center, Ochsner Clinic Foundation, New Orleans, LA, USA.'}]",Progress in cardiovascular diseases,['10.1016/j.pcad.2020.09.007']
1968,33007442,Operationalizing needs-focused palliative care for older adults in intensive care units: Design of and rationale for the PCplanner randomized clinical trial.,"INTRODUCTION


The number of older adults who receive life support in an intensive care unit (ICU), now 2 million per year, is increasing while survival remains unchanged. Because the quality of ICU-based palliative care is highly variable, we developed a mobile app intervention that integrates into the electronic health records (EHR) system called PCplanner (Palliative Care planner) with the goal of improving collaborative primary and specialist palliative care delivery in ICU settings.
OBJECTIVE


To describe the methods of a randomized clinical trial (RCT) being conducted to compare PCplanner vs. usual care.
METHODS AND ANALYSIS


The goal of this two-arm, parallel group mixed methods RCT is to determine the clinical impact of the PCplanner intervention on outcomes of interest to patients, family members, clinicians, and policymakers over a 3-month follow up period. The primary outcome is change in unmet palliative care needs measured by the NEST instrument between baseline and 1 week post-randomization. Secondary outcomes include goal concordance of care, patient-centeredness of care, and quality of communication at 1 week post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization. We will use general linear models for repeated measures to compare outcomes across the main effects and interactions of the factors. We hypothesize that compared to usual care, PCplanner will have a greater impact on the quality of ICU-based palliative care delivery across domains of core palliative care needs, psychological distress, patient-centeredness, and healthcare resource utilization.",2020,"Secondary outcomes include goal concordance of care, patient-centeredness of care, and quality of communication at 1 week post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization.",['older adults in intensive care units'],"['PCplanner intervention', 'PCplanner vs. usual care']","['goal concordance of care, patient-centeredness of care, and quality of communication at 1\u202fweek post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder', 'change in unmet palliative care needs measured by the NEST instrument']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",,0.166302,"Secondary outcomes include goal concordance of care, patient-centeredness of care, and quality of communication at 1 week post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization.","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: christopher.cox@duke.edu.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States of America; Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, Durham, NC, United States of America. Electronic address: maren.olsen@duke.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Casarett', 'Affiliation': 'Department of Medicine, Section of Palliative Care and Hospice Medicine, Duke University, Durham, NC, United States of America. Electronic address: David.casarett@duke.edu.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Haines', 'Affiliation': 'Department of Surgery, Division of Trauma and Critical Care and Acute Care Surgery, Duke University, Durham, North, Carolina;, United States of America. Electronic address: krista.haines@duke.edu.'}, {'ForeName': 'Mashael', 'Initials': 'M', 'LastName': 'Al-Hegelan', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: mashael.alhegelan@duke.edu.'}, {'ForeName': 'Raquel R', 'Initials': 'RR', 'LastName': 'Bartz', 'Affiliation': 'Department of Anesthesia, Division of Critical Care Medicine, Duke University, Durham, NC, United States of America. Electronic address: raquel.bartz@duke.edu.'}, {'ForeName': 'Jason N', 'Initials': 'JN', 'LastName': 'Katz', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke University, Durham, NC, United States of America. Electronic address: jason.katz@duke.edu.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Naglee', 'Affiliation': 'Department of Anesthesia, Division of Neurology, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Deepshikha', 'Initials': 'D', 'LastName': 'Ashana', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: deepshikha.ashana@duke.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gilstrap', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: daniel.gilstrap@duke.edu.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: jessie.gu@duke.edu.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Parish', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States of America. Electronic address: alice.parish@duke.edu.'}, {'ForeName': 'Allie', 'Initials': 'A', 'LastName': 'Frear', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: allie.frear@duke.edu.'}, {'ForeName': 'Deepthi', 'Initials': 'D', 'LastName': 'Krishnamaneni', 'Affiliation': 'Duke Health Technology Solutions, Duke University, Durham, NC, United States of America. Electronic address: deepthi.krishnamaneni@duke.edu.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Corcoran', 'Affiliation': 'Office of Academic Solutions and Information Systems, Duke University, Durham, NC, United States of America. Electronic address: andrew.corcoran@duke.edu.'}, {'ForeName': 'Sharron L', 'Initials': 'SL', 'LastName': 'Docherty', 'Affiliation': 'School of Nursing, Duke University, Durham, NC, United States of America. Electronic address: sharron.docherty@duke.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106163']
1969,33007709,Non-invasive ventilation improves exercise tolerance and peripheral vascular function after high-intensity exercise in COPD-HF patients.,"AIM


Evaluate the acute effects of non-invasive positive pressure ventilation (NiPPV) during high-intensity exercise on endothelial function in patients with coexisting chronic obstructive pulmonary disease (COPD) and heart failure (HF).
METHODS


This is a randomized, double blinded, sham-controlled study involving 14 COPD-HF patients, who underwent a lung function test and Doppler echocardiography. On two different days, patients performed incremental cardiopulmonary exercise testing (CPET) and two constant-work rate tests (80% of CPET peak) receiving Sham or NiPPV (bilevel mode - Astral 150) in a random order until the limit of tolerance (Tlim). Endothelial function was evaluated by flow mediated vasodilation (FMD) at three time points: 1) Baseline; 2) immediately post-exercise with NiPPV; and 3) immediately post-exercise with Sham.
RESULTS


Our patients had a mean age of 70 ± 7 years, FEV 1  1.9 ± 0.7 L and LVEF 41 ± 9%. NIPPV resulted in an increased Tlim (NiPPV: 130 ± 29s vs Sham: 98 ± 29s p = 0.015) and SpO 2  (NiPPV: 94.7 ± 3.5% vs Sham: 92.7 ± 5.2% p = 0.03). Also, NiPPV was able to produce a significant increase in FMD (%) (NiPPV: 9.2 ± 3.1 vs Sham: 3.6 ± 0.7, p < 0.05), FMD (mm) (NiPPV: 0.41 ± 0.18 vs Sham: 0.20 ± 0.11, p < 0.05), Blood flow velocity (NiPPV: 33 ± 18 vs Baseline: 20 ± 14, p < 0.05) and Shear Stress (SS) (NiPPV: 72 ± 38 vs Baseline: 43 ± 25, p < 0.05). We found correlation between Tlim vs. ΔSS (p = 0.03; r = 0.57). Univariate-regression analysis revealed that increased SS influenced 32% of Tlim during exercise with NiPPV.
CONCLUSION


NiPPV applied during high-intensity exercise can acutely modulate endothelial function and improve exercise tolerance in COPD-HF patients. In addition, the increase of SS positively influences exercise tolerance.",2020,NIPPV resulted in an increased Tlim (NiPPV: 130 ± 29s vs Sham: 98 ± 29s,"['patients with coexisting chronic obstructive pulmonary disease (COPD) and heart failure (HF', 'Our patients had a mean age of 70\xa0±\xa07 years, FEV 1', '14 COPD-HF patients, who underwent a lung function test and Doppler echocardiography', 'COPD-HF patients']","['non-invasive positive pressure ventilation (NiPPV', 'NIPPV', 'high-intensity exercise', 'incremental cardiopulmonary exercise testing (CPET) and two constant-work rate tests (80% of CPET peak) receiving Sham or NiPPV', 'NiPPV']","['Shear Stress (SS) ', 'SS positively influences exercise tolerance', 'Blood flow velocity', 'FMD', 'Endothelial function', 'exercise tolerance and peripheral vascular function', 'exercise tolerance', 'endothelial function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0055954', 'cui_str': 'Clostridium perfringens epsilon toxin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",14.0,0.444389,NIPPV resulted in an increased Tlim (NiPPV: 130 ± 29s vs Sham: 98 ± 29s,"[{'ForeName': 'Cássia', 'Initials': 'C', 'LastName': 'da Luz Goulart', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: Luz.cassia@hotmail.com.'}, {'ForeName': 'Flávia Rossi', 'Initials': 'FR', 'LastName': 'Caruso', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: fla.rossi@hotmail.com.'}, {'ForeName': 'Adriana S', 'Initials': 'AS', 'LastName': 'Garcia de Araújo', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: garciadrica@hotmail.com.'}, {'ForeName': 'Guilherme Peixoto', 'Initials': 'GP', 'LastName': 'Tinoco Arêas', 'Affiliation': 'Human Physiology Laboratory, Physiology Department, Federal University of Amazonas, UFAM, Manaus, AM, Brazil. Electronic address: Guilhermepta@hotmail.com.'}, {'ForeName': 'Sílvia Cristina', 'Initials': 'SC', 'LastName': 'Garcia de Moura', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physiotherapy Department, Federal University of São Carlos, Rod Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: silvinhacgmoura@gmail.com.'}, {'ForeName': 'Aparecida Maria', 'Initials': 'AM', 'LastName': 'Catai', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physiotherapy Department, Federal University of São Carlos, Rod Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: amcatai50@gmail.com.'}, {'ForeName': 'Renata Gonçalves', 'Initials': 'RG', 'LastName': 'Mendes', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: mendesrg@hotmail.com.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Phillips', 'Affiliation': 'Department of Physical Therapy, Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois at Chicago (UIC), Chicago, IL, USA. Electronic address: shanep@uic.edu.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Arena', 'Affiliation': 'Department of Physical Therapy, Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois at Chicago (UIC), Chicago, IL, USA. Electronic address: rarena70@gmail.com.'}, {'ForeName': 'Andréa Lúcia', 'Initials': 'AL', 'LastName': 'Gonçalves da Silva', 'Affiliation': 'Department of Physical Education and Health, University of Santa Cruz do Sul, Rio Grande do Sul, Brazil. Electronic address: andreag@unisc.br.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi-Silva', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: audrey@ufscar.br.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106173']
1970,33009241,"Amlodipine/valsartan fixed-dose combination treatment in the management of hypertension: A double-blind, randomized trial.","BACKGROUND


To compare the fixed-dose combination (FDC) of amlodipine/valsartan 5/80 mg with valsartan 160 mg monotherapy for efficacy and safety in hypertensive patients.
METHODS


We designed this double-blind, randomized, and noninferiority trial in which patients with elevated systolic blood pressure (SBP) and/or diastolic blood pressure (DBP) were randomly assigned to receive amlodipine/valsartan 5/80 mg FDC or valsartan 160 mg monotherapy for 8 weeks. The primary endpoint was changes in office SBP and DBP from baseline to 8 weeks. Twenty-four-hour blood pressure (BP) and the incidence of adverse events were recorded.
RESULTS


A total of 42 patients underwent randomization. At 8 weeks, office SBP changes were -16.5 ± 15.5 mmHg (p < 0.001) with amlodipine/valsartan 5/80 mg FDC and -6.9 ± 11.4 mmHg (p = 0.012) with valsartan 160 mg monotherapy while corresponding changes in office DBP were -9.8 ± 7.7 mmHg (p < 0.001) and -2.5 ± 6.6 mmHg (p = 0.095), respectively. The between-group differences were -9.6 mmHg (95% CI, -18.1 to -1.1; p = 0.028) for SBP and -7.3 mmHg (95% CI, -11.8 to -2.8; p = 0.002) for DBP. Furthermore, reductions in both 24-hour SBP (-9.2 mmHg; 95% CI, -16.4 to -2.1; p = 0.013) and DBP (-4.6 mmHg; 95% CI, -9.2 to -0.1; p = 0.048) were consistently greater with amlodipine/valsartan 5/80 mg FDC than with valsartan 160 mg. Overall, 27 and 23 adverse events occurred in the amlodipine/valsartan 5/80 mg FDC group and in the valsartan 160 mg monotherapy group, respectively. The majority were mild and were not related to study medications. There were no significant differences in safety between two treatments.
CONCLUSION


Efficacy of amlodipine/valsartan 5/80 mg FDC was superior to that of valsartan 160 mg monotherapy while both treatments were well-tolerated.",2020,"At 8 weeks, office SBP changes were -16.5 ± 15.5 mmHg (p < 0.001) with amlodipine/valsartan 5/80 mg FDC and -6.9 ± 11.4 mmHg (p = 0.012) with valsartan 160 mg monotherapy while corresponding changes in office DBP were -9.8 ± 7.7 mmHg (p < 0.001) and -2.5 ± 6.6 mmHg (p = 0.095), respectively.","['hypertension', '42 patients underwent randomization', 'patients with elevated systolic blood pressure (SBP) and/or diastolic blood pressure (DBP', 'hypertensive patients']","['valsartan 160\u2009mg monotherapy', 'amlodipine/valsartan 5/80\u2009mg FDC or valsartan 160\u2009mg monotherapy', 'amlodipine/valsartan', 'valsartan', 'FDC', 'Amlodipine/valsartan fixed-dose combination treatment']","['DBP', '24-hour SBP', 'blood pressure (BP) and the incidence of adverse events', 'efficacy and safety', 'office SBP and DBP', 'safety', 'office SBP changes', 'tolerated']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0991106', 'cui_str': 'valsartan 160 MG'}, {'cui': 'C1962523', 'cui_str': 'valsartan and amlodipine'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1282174', 'cui_str': '24 hour systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",42.0,0.203794,"At 8 weeks, office SBP changes were -16.5 ± 15.5 mmHg (p < 0.001) with amlodipine/valsartan 5/80 mg FDC and -6.9 ± 11.4 mmHg (p = 0.012) with valsartan 160 mg monotherapy while corresponding changes in office DBP were -9.8 ± 7.7 mmHg (p < 0.001) and -2.5 ± 6.6 mmHg (p = 0.095), respectively.","[{'ForeName': 'Kang-Ling', 'Initials': 'KL', 'LastName': 'Wang', 'Affiliation': 'General Clinical Research Center, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Wen-Chung', 'Initials': 'WC', 'LastName': 'Yu', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Tse-Min', 'Initials': 'TM', 'LastName': 'Lu', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Lung-Ching', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Hsin-Bang', 'Initials': 'HB', 'LastName': 'Leu', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chern-En', 'Initials': 'CE', 'LastName': 'Chiang', 'Affiliation': 'General Clinical Research Center, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}]",Journal of the Chinese Medical Association : JCMA,['10.1097/JCMA.0000000000000386']
1971,33010843,"Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial.","BACKGROUND


Manipulation under anaesthesia and arthroscopic capsular release are costly and invasive treatments for frozen shoulder, but their effectiveness remains uncertain. We compared these two surgical interventions with early structured physiotherapy plus steroid injection.
METHODS


In this multicentre, pragmatic, three-arm, superiority randomised trial, patients referred to secondary care for treatment of primary frozen shoulder were recruited from 35 hospital sites in the UK. Participants were adults (≥18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation (≥50%) in the affected shoulder. Participants were randomly assigned (2:2:1) to receive manipulation under anaesthesia, arthroscopic capsular release, or early structured physiotherapy. In manipulation under anaesthesia, the surgeon manipulated the affected shoulder to stretch and tear the tight capsule while the participant was under general anaesthesia, supplemented by a steroid injection. Arthroscopic capsular release, also done under general anaesthesia, involved surgically dividing the contracted anterior capsule in the rotator interval, followed by manipulation, with optional steroid injection. Both forms of surgery were followed by postprocedural physiotherapy. Early structured physiotherapy involved mobilisation techniques and a graduated home exercise programme supplemented by a steroid injection. Both early structured physiotherapy and postprocedural physiotherapy involved 12 sessions during up to 12 weeks. The primary outcome was the Oxford Shoulder Score (OSS; 0-48) at 12 months after randomisation, analysed by initial randomisation group. We sought a target difference of 5 OSS points between physiotherapy and either form of surgery, or 4 points between manipulation and capsular release. The trial registration is ISRCTN48804508.
FINDINGS


Between April 1, 2015, and Dec 31, 2017, we screened 914 patients, of whom 503 (55%) were randomly assigned. At 12 months, OSS data were available for 189 (94%) of 201 participants assigned to manipulation (mean estimate 38·3 points, 95% CI 36·9 to 39·7), 191 (94%) of 203 participants assigned to capsular release (40·3 points, 38·9 to 41·7), and 93 (94%) of 99 participants assigned to physiotherapy (37·2 points, 35·3 to 39·2). The mean group differences were 2·01 points (0·10 to 3·91) between the capsular release and manipulation groups, 3·06 points (0·71 to 5·41) between capsular release and physiotherapy, and 1·05 points (-1·28 to 3·39) between manipulation and physiotherapy. Eight serious adverse events were reported with capsular release and two with manipulation. At a willingness-to-pay threshold of £20 000 per quality-adjusted life-year, manipulation under anaesthesia had the highest probability of being cost-effective (0·8632, compared with 0·1366 for physiotherapy and 0·0002 for capsular release).
INTERPRETATION


All mean differences on the assessment of shoulder pain and function (OSS) at the primary endpoint of 12 months were less than the target differences. Therefore, none of the three interventions were clinically superior. Arthoscopic capsular release carried higher risks, and manipulation under anaesthesia was the most cost-effective.
FUNDING


The National Institute for Health Research Health Technology Assessment programme.",2020,All mean differences on the assessment of shoulder pain and function (OSS) at the primary endpoint of 12 months were less than the target differences.,"['Between April 1, 2015, and Dec 31, 2017, we screened 914 patients, of whom 503 (55', 'Participants were adults (≥18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation (≥50%) in the affected shoulder', 'adults with primary frozen shoulder in secondary care (UK FROST', 'patients referred to secondary care for treatment of primary frozen shoulder were recruited from 35 hospital sites in the UK']","['graduated home exercise programme supplemented by a steroid injection', 'manipulation under anaesthesia, arthroscopic capsular release, or early structured physiotherapy']","['shoulder pain and function (OSS', 'Oxford Shoulder Score']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0311223', 'cui_str': 'Adhesive capsulitis of shoulder'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0498269', 'cui_str': 'Manipulation under anesthesia'}, {'cui': 'C2936277', 'cui_str': 'Arthroscopic Capsular Release'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2960740', 'cui_str': 'Oxford shoulder score'}]",,0.145395,All mean differences on the assessment of shoulder pain and function (OSS) at the primary endpoint of 12 months were less than the target differences.,"[{'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Rangan', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK; The James Cook University Hospital, South Tees Hospitals National Health Service (NHS) Foundation Trust, Middlesbrough, UK. Electronic address: amar.rangan@york.ac.uk.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Brealey', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Keding', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Corbacho', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Northgraves', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Lucksy', 'Initials': 'L', 'LastName': 'Kottam', 'Affiliation': 'The James Cook University Hospital, South Tees Hospitals National Health Service (NHS) Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Goodchild', 'Affiliation': 'The James Cook University Hospital, South Tees Hospitals National Health Service (NHS) Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Srikesavan', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Saleema', 'Initials': 'S', 'LastName': 'Rex', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Charalambos P', 'Initials': 'CP', 'LastName': 'Charalambous', 'Affiliation': 'Department of Orthopaedics, Blackpool Victoria Hospital, Blackpool, UK; School of Medicine, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Hanchard', 'Affiliation': 'School of Health and Social Care, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Armstrong', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Brooksbank', 'Affiliation': 'Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Carr', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Cushla', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Dias', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Iona', 'Initials': 'I', 'LastName': 'Donnelly', 'Affiliation': 'Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'McDaid', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Rodgers', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sharp', 'Affiliation': 'Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Spencer', 'Affiliation': 'Postgraduate Medical Institute, Edge Hill University, Ormskirk, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Toye', 'Affiliation': 'Physiotherapy Research Unit, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31965-6']
1972,33011429,Training older adults with virtual reality use to improve collision-avoidance behavior when walking through an aperture.,"Many older adults perform collision-avoidance behavior either insufficiently (i.e., frequent collision) or inefficiently (i.e., exaggerated behavior to ensure collision-avoidance). The present study examined whether a training system using virtual reality (VR) simulation enhanced older adults' collision-avoidance behavior in response to a VR image of an aperture during real walking. Twenty-five (n = 13 intervention group and n = 12 control group) older individuals participated. During training, a VR image of walking through an aperture was projected onto a large screen. Participants in the intervention group tried to avoid virtual collision with the minimum body rotation required to walk on the spot through a variety of narrow apertures. Participants in the control group remained without body rotation while walking on the spot through a wide aperture. A comparison between pre-test and post-test performances in the real environment indicated that after the training, significantly smaller body rotation angles were observed in the intervention group. This suggests that the training led participants to modify their behavior to try to move efficiently during real walking. However, although not significant, collision rates also tended to be greater, suggesting that, at least for some participants, the modification required to avoid collision was too difficult. Transfer of the learned behavior using the VR environment to real walking is discussed.",2020,"A comparison between pre-test and post-test performances in the real environment indicated that after the training, significantly smaller body rotation angles were observed in the intervention group.","['Training older adults with virtual reality', 'n\u202f=\u202f12 control group) older individuals participated']","['avoid virtual collision with the minimum body rotation required to walk on the spot through a variety of narrow apertures', 'training system using virtual reality (VR) simulation']","['body rotation', 'collision rates', 'smaller body rotation angles']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",,0.0141464,"A comparison between pre-test and post-test performances in the real environment indicated that after the training, significantly smaller body rotation angles were observed in the intervention group.","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan; Department of Physical Rehabilitation, National Center Hospital, National Center of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Kazunobu', 'Initials': 'K', 'LastName': 'Fukuhara', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Suda', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan. Electronic address: higuchit@tmu.ac.jp.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104265']
1973,33011482,Combined utility of blood glucose and white blood cell in predicting outcome after acute ischemic stroke: The ENCHANTED trial.,"BACKGROUND


As hyperglycemia and leukocytosis individually predict poor outcome in acute ischemic stroke (AIS), we aimed to determine the significance of their combination on functional outcome and symptomatic intracerebral hemorrhage (sICH) among participants of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED).
METHODS


Post-hoc analyzes of the full ENCHANTED cohort, an international, multicenter, quasi-factorial, randomized, open, blinded outcome-assessed trial of low- versus standard-dose intravenous alteplase and early intensive versus standard blood pressure (BaP) lowering treatment in 4557 thrombolysis-eligible and treated AIS patients. Patients were divided into four groups according to baseline blood glucose and white blood cells (WBC) levels: A (normal glucose + WBC), B (hyperglycemia + normal WBC), C (normal glucose + high WBC), and D (hyperglycemia + high WBC). Logistic regression models were used to determine associations of each group and poor functional outcome (modified Rankin scale scores 2-6) at 90 days and sICH within 48 h, adjusted for confounders. Quality of model fit was examined with Akaike information classification (AIC), Bayesian information classification (BIC), and likelihood ratio test.
RESULTS


Of 4181 AIS patients included in analyzes, and with group A as the reference, an increasing odds of poor functional outcome was evident across groups B (odds ratio [OR] 1.38, 95 % confidence interval [CI] 1.17-1.63), C (OR 1.26, 95 %CI 0.99-1.60), and D (OR 2.26, 95 %CI 1.79-2.85) (P trend <0.001). Group D patients also had a higher rate of sICH (P trend <0.05). The model fit with the combination of blood glucose and WBC was better than models of their individual components.
CONCLUSIONS


Using a combination of blood glucose and WBC provides strong prognostic significance than either alone in thrombolyzed AIS patients.",2020,Group D patients also had a higher rate of sICH (P trend <0.05).,"['4557 thrombolysis-eligible and treated AIS patients', 'participants of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED', 'acute ischemic stroke', '4181 AIS patients', 'acute ischemic stroke (AIS', 'thrombolyzed AIS patients']","['low- versus standard-dose intravenous alteplase and early intensive versus standard blood pressure (BaP) lowering treatment', 'blood glucose and white blood cell']","['rate of sICH', 'baseline blood glucose and white blood cells (WBC) levels: A (normal glucose\u2009+\u2009WBC), B (hyperglycemia\u2009+\u2009normal WBC), C (normal glucose\u2009+\u2009high WBC), and D (hyperglycemia\u2009+\u2009high WBC', 'blood glucose and WBC', 'Akaike information classification (AIC), Bayesian information classification (BIC), and likelihood ratio test']","[{'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0860800', 'cui_str': 'Glucose normal'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0885454,Group D patients also had a higher rate of sICH (P trend <0.05).,"[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xia', 'Affiliation': 'Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China; The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'Westmead Applied Research Centre, University of Sydney, Sydney, NSW, Australia; The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Delcourt', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Department of Neurology, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia.'}, {'ForeName': 'Zien', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Department of Radiology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, PR China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Carcel', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Department of Neurology, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Malavera', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Zeljka', 'Initials': 'Z', 'LastName': 'Calic', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Department of Neurology, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia; The George Institute China at Peking University Health Science Centre, Beijing, PR China; Heart Health Research Center, Beijing, PR China. Electronic address: canderson@georgeinstitute.org.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106254']
1974,33011502,"Intrauterine fundal anaesthesia during endometrial ablation in the office: A randomised double-blind, non-inferiority trial.","OBJECTIVE


To evaluate the effect of intrauterine fundal anaesthesia during outpatient endometrial ablation.
STUDY DESIGN


A randomised, double-blinded non-inferiority trial was performed in one hospital and one independent treatment center in the Netherlands. A total of 96 women who were planned for a NovaSure® endometrial ablation under local anaesthesia between December 2015 and February 2018 were included in this trial. These women were randomised to paracervical anaesthesia combined with hysteroscopic fundal infiltration with anaesthestics or paracervical anaesthesia combined with hysteroscopic fundal infiltration with saline. The primary outcome was pain during ablation. To study non-inferiority of paracervical anaesthesia without fundal anaesthesia, we assessed the co-primary endpoints Faces Pain Score and Numeric Rating Score. Secondary outcomes included pain scores at other moments during and after the procedure, postoperative use of analgesics, satisfaction, side-effects and complications. The primary outcomes were tested with a non-inferiority margin (2.0 points on changes in pain), and the secondary outcomes were compared using conventional statistical methods.
RESULTS


Paracervical anaesthesia without fundal anaesthesia did not establish non-inferiority to the combination of paracervical anaesthesia and fundal infiltration with anaesthetics when both primary outcome variables of pain were taken into account (Numeric Rating Scale 5.0 versus 3.9 (mean difference 1.2 (95% CI 0.1-2.2)) and Faces Pain Score 5.4 versus 4.8 (mean difference 0.6 (95% CI -0.3-1.5))). Secondary pain scores measured during the procedure were higher or similar in women receiving fundal infiltration with saline as compared to women who received fundal infiltration with anaesthetics. After the procedure, there were no differences in reported pain scores, satisfaction, and side-effects. In the group who received fundal infiltration with saline, more women were admitted to the hospital because of severe pain (3 versus 0 women) and endometritis (1 versus 0 women).
CONCLUSION


This study did not confirm non-inferiority of paracervical anaesthesia without fundal anaesthesia to the combination of paracervical anaesthesia with fundal anaesthesia in the reduction of pain during endometrial ablation and therefore provides no reason to leave out fundal anaesthesia. We recommend to use fundal anaesthesia combined with paracervical anaesthesia to reduce pain during endometrial ablation in the office.",2020,Secondary pain scores measured during the procedure were higher or similar in women receiving fundal infiltration with saline as compared to women who received fundal infiltration with anaesthetics.,"['Intrauterine fundal anaesthesia during endometrial ablation in the office', 'women were admitted to the hospital because of severe pain (3 versus 0 women) and endometritis (1 versus 0 women', '96 women who were planned for a NovaSure® endometrial ablation under local anaesthesia between December 2015 and February 2018 were included in this trial', 'one hospital and one independent treatment center in the Netherlands']","['paracervical anaesthesia with fundal anaesthesia', 'fundal infiltration with saline', 'paracervical anaesthesia combined with hysteroscopic fundal infiltration with anaesthestics or paracervical anaesthesia combined with hysteroscopic fundal infiltration with saline', 'paracervical anaesthesia without fundal anaesthesia', 'intrauterine fundal anaesthesia', 'fundal anaesthesia combined with paracervical anaesthesia']","['Secondary pain scores', 'co-primary endpoints Faces Pain Score and Numeric Rating Score', 'pain scores at other moments during and after the procedure, postoperative use of analgesics, satisfaction, side-effects and complications', 'pain scores, satisfaction, and side-effects', 'non-inferiority margin (2.0 points on changes in pain', 'pain during ablation', 'Faces Pain Score', 'pain']","[{'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0341803', 'cui_str': 'Endometrial ablation'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]",96.0,0.583245,Secondary pain scores measured during the procedure were higher or similar in women receiving fundal infiltration with saline as compared to women who received fundal infiltration with anaesthetics.,"[{'ForeName': 'I M A', 'Initials': 'IMA', 'LastName': 'Reinders', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, the Netherlands; Department of Obstetrics and Gynaecology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, the Netherlands. Electronic address: imke.reinders@maastrichtuniversity.nl.'}, {'ForeName': 'P M A J', 'Initials': 'PMAJ', 'LastName': 'Geomini', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, the Netherlands. Electronic address: P.Geomini@mmc.nl.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Leemans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, the Netherlands. Electronic address: Jaklien.Leemans@mmc.nl.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Dieleman', 'Affiliation': 'Science Office, Academy, Máxima MC, Veldhoven, the Netherlands. Electronic address: J.Dieleman@mmc.nl.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Timmermans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, the Netherlands; Bergman Clinics Vrouw, Amsterdam, AMC, the Netherlands. Electronic address: a.timmermans@amsterdamumc.nl.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'de Lange', 'Affiliation': 'Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, the Netherlands; Bergman Clinics Vrouw, Amsterdam, AMC, the Netherlands. Electronic address: m.e.delange@amsterdamumc.nl.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, the Netherlands; Department of Obstetrics and Gynaecology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, the Netherlands. Electronic address: M.Bongers@mmc.nl.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.09.011']
1975,33011539,Genital Self-Image in Adolescent Girls: The Effectiveness of a Brief Educational Video.,"The study investigated the effectiveness of a very brief video aimed at increasing adolescent girls' knowledge of the variation in normal female genital appearance and improving their attitudes towards their own genitals. The video was developed by the researchers and included information about the anatomical features of cisgender female genitals and their function, as well as emphasizing the diversity in the appearance of these features, particularly the external genitalia or vulvar region. A sample of 343 female adolescents aged 16-18 years were randomly assigned to view the educational video or a control video. The educational video significantly increased the girls' knowledge of female genital anatomy. The educational video also significantly increased genital appearance satisfaction and decreased consideration of undergoing cosmetic genital surgery or labiaplasty in the future. The participants who watched the educational video were also more likely to recommend focusing on the diversity in normal female genital appearance when educating other young people on the topic of female genital anatomy. Our results suggest that a very brief educational video could be a useful tool to assist young girls with their genital self-image.",2020,The educational video also significantly increased genital appearance satisfaction and decreased consideration of undergoing cosmetic genital surgery or labiaplasty in the future.,"['adolescent girls', '343 female adolescents aged 16-18 years', 'Adolescent Girls']","['educational video or a control video', 'Brief Educational Video']","['genital appearance satisfaction', 'Genital Self-Image', ""girls' knowledge of female genital anatomy""]","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0017421', 'cui_str': 'Female genital'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}]",343.0,0.014125,The educational video also significantly increased genital appearance satisfaction and decreased consideration of undergoing cosmetic genital surgery or labiaplasty in the future.,"[{'ForeName': 'Anne Nileshni', 'Initials': 'AN', 'LastName': 'Fernando', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, Monash University, Melbourne, Victoria, 3004, Australia. Electronic address: anfer4@student.monash.edu.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Sharp', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, Monash University, Melbourne, Victoria, 3004, Australia. Electronic address: gemma.sharp@monash.edu.'}]",Body image,['10.1016/j.bodyim.2020.08.007']
1976,33027403,Economic and epidemiological evaluation of text message-based interventions in patients with the Human Immunodeficiency Virus.,"OBJECTIVE


to evaluate the cost-effectiveness ratio and the budget impact of sending text messages associated with medical consultations in order to reduce the viral load of patients infected with the Human Immunodeficiency Virus.
METHOD


a randomized clinical trial, basis for the development of a dynamic cohort model with Markov states in order to compare medical appointments for adults infected with the Human Immunodeficiency Virus versus the alternative strategy that associated medical consultations to sending text messages through telephone.
RESULTS


156 adults participated in the study. As for the viral load, it was verified that in the control group there was an increase, in the intervention group A (weekly messages) there was a reduction (p = 0.002) and in group B (biweekly messages) there was no statistically significant difference. Sending text messages would prevent 286,538 new infections by the Human Immunodeficiency Virus and 282 deaths in the 20-year period, compared to the standard treatment. The alternative strategy would result in saving R$ 14 billion in treatment costs.
CONCLUSION


weekly sending messages in association with the standard treatment can reduce the circulating viral load due to its effect in decreasing new infections, in addition to reducing health costs.",2020,"As for the viral load, it was verified that in the control group there was an increase, in the intervention group A (weekly messages) there was a reduction (p = 0.002) and in group B (biweekly messages) there was no statistically significant difference.","['156 adults participated in the study', 'patients with the Human Immunodeficiency Virus', 'adults infected with the Human Immunodeficiency Virus versus the alternative strategy that associated medical consultations to sending text messages through telephone', 'patients infected with the Human Immunodeficiency Virus']",['text message-based interventions'],['cost-effectiveness ratio'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",156.0,0.0270667,"As for the viral load, it was verified that in the control group there was an increase, in the intervention group A (weekly messages) there was a reduction (p = 0.002) and in group B (biweekly messages) there was no statistically significant difference.","[{'ForeName': 'Wendel Mombaque Dos', 'Initials': 'WMD', 'LastName': 'Santos', 'Affiliation': 'Empresa Brasileira de Serviços Hospitalares, Hospital Universitário de Santa Maria, Santa Maria, RS, Brazil.'}, {'ForeName': 'Marcelo Ribeiro', 'Initials': 'MR', 'LastName': 'Primeira', 'Affiliation': 'Universidade Federal de Santa Maria, Departamento de Enfermagem, Santa Maria, RS, Brazil.'}, {'ForeName': 'Larissa Garcia de', 'Initials': 'LG', 'LastName': 'Paiva', 'Affiliation': 'Universidade Federal de Santa Maria, Departamento de Enfermagem, Santa Maria, RS, Brazil.'}, {'ForeName': 'Stela Maris de Mello', 'Initials': 'SMM', 'LastName': 'Padoin', 'Affiliation': 'Universidade Federal de Santa Maria, Departamento de Enfermagem, Santa Maria, RS, Brazil.'}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.3614.3365']
1977,33027448,Children First Study II: an educational programme on cardiovascular prevention in public schools can reduce parents' cardiovascular risk.,"OBJECTIVE


The aim of this study was to analyze whether the implementation of a multidisciplinary educational programme for cardiovascular prevention in public schools can contribute to reducing the FramINGHAM CARDIOVASCULAR RISK SCORE OF THE CHILDREN'S PARENTS AFTER ONE YEAR.
METHODS


This was a prospective, community-based, case-control study carried out in public schools in Sao Paulo, Brasil. Students were randomized to receive healthy lifestyle recommendations by two different approaches. The control group received written cardiovascular health educational brochures for their parents. The intervention group received the same brochures for the parents, and the children were exposed to a weekly educational programme on cardiovascular prevention with a multidisciplinary health team for one year. Clinical and laboratorial data were collected at the onset and end of the study.
RESULTS


We studied 265 children and their 418 parents. At the baseline, the rate of parents with intermediate or high Framingham scores (risk of cardiovascular disease over the next 10 years greater than 10%) was 6.9% in the control group and 13.3% in the intervention group. After one year, the rate of parents with intermediate or high Framingham risk score was reduced by 22.2% in the intervention group and increased by 33.3% in the control group (p=0.031). The cardiovascular risk factors that improved in the intervention group were blood pressure, LDL-cholesterol (low-density lipoprotein cholesterol), and glucose levels.
CONCLUSION


An educational programme on cardiovascular prevention for school-age children in public schools can reduce the cardiovascular risk of their parents.",2020,"The cardiovascular risk factors that improved in the intervention group were blood pressure, LDL-cholesterol (low-density lipoprotein cholesterol), and glucose levels.
","['265 children and their 418 parents', 'public schools', 'school-age children in public schools', 'public schools in Sao Paulo, Brasil']","['written cardiovascular health educational brochures', 'multidisciplinary educational programme', 'educational programme on cardiovascular prevention with a multidisciplinary health team for one year', 'educational programme']","['cardiovascular risk factors', 'rate of parents with intermediate or high Framingham scores (risk of cardiovascular disease', 'blood pressure, LDL-cholesterol (low-density lipoprotein cholesterol), and glucose levels', 'rate of parents with intermediate or high Framingham risk score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]",265.0,0.0383702,"The cardiovascular risk factors that improved in the intervention group were blood pressure, LDL-cholesterol (low-density lipoprotein cholesterol), and glucose levels.
","[{'ForeName': 'Cristiano J M', 'Initials': 'CJM', 'LastName': 'Pinto', 'Affiliation': 'Universidade de São Paulo, São Paulo, SP, Brasil.'}, {'ForeName': 'Luciana S', 'Initials': 'LS', 'LastName': 'Fornari', 'Affiliation': 'Universidade de São Paulo, São Paulo, SP, Brasil.'}, {'ForeName': 'Silvia M R', 'Initials': 'SMR', 'LastName': 'Oyama', 'Affiliation': 'Universidade Padre Anchieta, São Paulo, SP, Brasil.'}, {'ForeName': 'Maria M D', 'Initials': 'MMD', 'LastName': 'Rodrigues', 'Affiliation': 'Universidade Padre Anchieta, São Paulo, SP, Brasil.'}, {'ForeName': 'Taciana', 'Initials': 'T', 'LastName': 'Davanço', 'Affiliation': 'Universidade Padre Anchieta, São Paulo, SP, Brasil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Caramelli', 'Affiliation': 'InCor, Universidade de São Paulo, São Paulo, SP, Brasil.'}]",Revista da Associacao Medica Brasileira (1992),['10.1590/1806-9282.66.9.1217']
1978,33028387,'Mothers moving towards empowerment' intervention to reduce stigma and improve treatment adherence in pregnant women living with HIV in Botswana: study protocol for a pragmatic clinical trial.,"BACKGROUND


With high rates of HIV and multiple vulnerable subgroups across diverse settings, there is a need for culturally based, HIV stigma reduction interventions. Pregnant women who are living with HIV are especially in need of services to protect not only their own but also their children's lives. Uptake of HIV services worldwide is hindered by stigma towards persons living with HIV/AIDS. While cultural context plays a key role in shaping HIV stigma, these insights have not yet been fully integrated into stigma reduction strategies. By utilizing the ""What Matters Most"" stigma framework, we propose that an intervention to counter culturally salient aspects of HIV stigma will improve treatment adherence and other relevant outcomes. A pragmatic clinical trial in Botswana will evaluate the ""Mothers Moving towards Empowerment"" (MME) intervention, which seeks to address HIV stigma in Botswana and to specifically engage pregnant mothers so as to promote antiretroviral therapy (ART) adherence in the postpartum period.
METHODS


This study will test MME against treatment as usual (TAU) among pregnant mothers diagnosed with HIV and their infants. Outcomes will be assessed during pregnancy and 16 weeks postpartum. Women who meet eligibility criteria are assigned to MME or TAU. Women assigned to MME are grouped with others with similar estimated delivery dates, completing up to eight intervention group sessions scheduled before week 36 of their pregnancies. Primary outcomes among mothers include (i) reducing self-stigma, which is hypothesized to mediate improvements in (ii) psychological outcomes (quality of life, depression and social functioning), and (iii) adherence to antenatal care and ART. We will also examine a set of follow-up infant birth outcomes (APGAR score, preterm delivery, mortality (at < 16 weeks), birth weight, vaccination record, and HIV status).
DISCUSSION


Our trial will evaluate MME, a culturally based HIV stigma reduction intervention using the ""What Matters Most"" framework, to reduce stigma and improve treatment adherence among pregnant women and their infants. This study will help inform further refinement of MME and preparation for a future large-scale, multisite, randomized controlled trial (RCT) in Botswana.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03698981 . Registered on October 8, 2018.",2020,Pregnant women who are living with HIV are especially in need of services to protect not only their own but also their children's lives.,"['Pregnant women who are living with HIV', 'pregnant mothers diagnosed with HIV and their infants', 'pregnant women living with HIV in Botswana', 'pregnant women and their infants', 'persons living with HIV/AIDS']","['MME or TAU', 'MME', ""Mothers moving towards empowerment' intervention"", 'Mothers Moving towards Empowerment"" (MME) intervention']","['mediate improvements in (ii) psychological outcomes (quality of life, depression and social functioning), and (iii) adherence to antenatal care and ART', 'infant birth outcomes (APGAR score, preterm delivery, mortality (at <\u200916\u2009weeks), birth weight, vaccination record, and HIV status', 'mothers include (i) reducing self-stigma']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]",,0.219555,Pregnant women who are living with HIV are especially in need of services to protect not only their own but also their children's lives.,"[{'ForeName': 'Ohemaa B', 'Initials': 'OB', 'LastName': 'Poku', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States. opoku1@jh.edu.'}, {'ForeName': 'Ari R', 'Initials': 'AR', 'LastName': 'Ho-Foster', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Patlo', 'Initials': 'P', 'LastName': 'Entaile', 'Affiliation': 'Botswana-UPenn Partnership, Gaborone, Botswana.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Misra', 'Affiliation': 'New York University, New York, NY, United States.'}, {'ForeName': 'Haitisha', 'Initials': 'H', 'LastName': 'Mehta', 'Affiliation': 'Columbia University, New York, NY, United States.'}, {'ForeName': 'Shathani', 'Initials': 'S', 'LastName': 'Rampa', 'Affiliation': 'University of Botswana, Gaborone, Botswana.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Goodman', 'Affiliation': 'New York University, New York, NY, United States.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Arscott-Mills', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Eschliman', 'Affiliation': 'Columbia University, New York, NY, United States.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Jackson', 'Affiliation': 'University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Tadele', 'Initials': 'T', 'LastName': 'Melese', 'Affiliation': 'University of Botswana, Gaborone, Botswana.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Becker', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Eisenberg', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Link', 'Affiliation': 'University of California Riverside, Riverside, CA, USA.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Go', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hil, NC, USA.'}, {'ForeName': 'Philip Renison', 'Initials': 'PR', 'LastName': 'Opondo', 'Affiliation': 'University of Botswana, Gaborone, Botswana.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Blank', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Yang', 'Affiliation': 'New York University, New York, NY, United States.'}]",Trials,['10.1186/s13063-020-04676-6']
1979,33028396,"Xanthohumol microbiome and signature in healthy adults (the XMaS trial): a phase I triple-masked, placebo-controlled clinical trial.","BACKGROUND


Natural products may provide a source for the discovery and development of adjunctive pharmacological interventions to modulate the inflammatory pathways contributing to chronic disease. Xanthohumol, a flavonoid from the hops plant (Humulus lupulus), has antioxidant and anti-inflammatory properties and may act as a prebiotic to the intestinal microbiota. Xanthohumol is not currently approved as a drug by the US Food and Drug Administration (FDA), but is available as a dietary supplement and ingredient in medical foods. To formally test the safety of xanthohumol, a phase I clinical trial (""XMaS"") was designed and approved under an Investigational New Drug application to the US FDA. The main objective is to examine the clinical safety and subjective tolerability of xanthohumol in healthy adults compared to placebo. Additional aims are to monitor biomarkers related to inflammation, gut permeability, bile acid metabolism, routes, and in vivo products of xanthohumol metabolism, and to evaluate xanthohumol's impact on gut microbial composition.
METHODS


The safety and tolerability of xanthohumol in healthy adults will be evaluated in a triple-masked, randomized, placebo-controlled trial. Participants will be randomized to either 24 mg/day of xanthohumol or placebo for 8 weeks. Blood cell counts, hepatic and renal function tests, electrolytes, and self-reported health-related quality of life measures will be collected every 2 weeks. Participants will be queried for adverse events throughout the trial. Xanthohumol metabolites in blood, urine, and stool will be measured. Biomarkers to be evaluated include plasma tumor necrosis factor-alpha, various interleukins, soluble CD14, lipopolysaccharide-binding protein, fecal calprotectin, and bile acids to assess impact on inflammatory and gut permeability-related mechanisms in vivo. Stool samples will be analyzed to determine effects on the gut microbiome.
DISCUSSION


This phase I clinical trial of xanthohumol will assess safety and tolerability in healthy adults, collect extensive biomarker data for assessment of potential mechanism(s), and provide comparison data necessary for future phase II trials in chronic disease(s). The design and robustness of the planned safety and mechanistic evaluations planned provide a model for drug discovery pursuits from natural products.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03735420 . Registered on November 8, 2018.",2020,"Blood cell counts, hepatic and renal function tests, electrolytes, and self-reported health-related quality of life measures will be collected every 2 weeks.",['healthy adults'],"['xanthohumol or placebo', 'Xanthohumol', 'placebo', 'Xanthohumol microbiome', 'xanthohumol']","['safety and tolerability', 'clinical safety and subjective tolerability', 'Blood cell counts, hepatic and renal function tests, electrolytes, and self-reported health-related quality of life measures', 'Xanthohumol metabolites in blood, urine, and stool']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0536128', 'cui_str': 'xanthohumol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0536128', 'cui_str': 'xanthohumol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0015733', 'cui_str': 'Feces'}]",,0.329114,"Blood cell counts, hepatic and renal function tests, electrolytes, and self-reported health-related quality of life measures will be collected every 2 weeks.","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Bradley', 'Affiliation': 'National University of Natural Medicine, Portland, USA. rbradley@nunm.edu.'}, {'ForeName': 'Blake O', 'Initials': 'BO', 'LastName': 'Langley', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Ryan', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Phipps', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Hanes', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Stack', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Jansson', 'Affiliation': 'Pacific Northwest National Laboratory, Richland, USA.'}, {'ForeName': 'Thomas O', 'Initials': 'TO', 'LastName': 'Metz', 'Affiliation': 'Pacific Northwest National Laboratory, Richland, USA.'}, {'ForeName': 'Jan Frederik', 'Initials': 'JF', 'LastName': 'Stevens', 'Affiliation': 'Oregon State University, Corvallis, USA.'}]",Trials,['10.1186/s13063-020-04769-2']
1980,33032564,The effect of an online exercise programme on bone health in paediatric cancer survivors (iBoneFIT): study protocol of a multi-centre randomized controlled trial.,"BACKGROUND


New approaches on paediatric cancer treatment aim to maintain long-term health. As a result of radiotherapy, chemotherapy or surgery, paediatric cancer survivors tend to suffer from any chronic health condition. Endocrine dysfunction represents one of the most common issues and affects bone health. Exercise is key for bone mass accrual during growth, specifically plyometric jump training. The iBoneFIT study will investigate the effect of a 9-month online exercise programme on bone health in paediatric cancer survivors. This study will also examine the effect of the intervention on body composition, physical fitness, physical activity, calcium intake, vitamin D, blood samples quality of life and mental health.
METHODS


A minimum of 116 participants aged 6 to 18 years will be randomized into an intervention (n = 58) or control group (n = 58). The intervention group will receive an online exercise programme and diet counselling on calcium and vitamin D. In addition, five behaviour change techniques and a gamification design will be implemented in order to increase the interest of this non-game programme. The control group will only receive diet counselling. Participants will be assessed on 3 occasions: 1) at baseline; 2) after the 9 months of the intervention; 3) 4 months following the intervention. The primary outcome will be determined by dual energy X-ray absorptiometry (DXA) and the hip structural analysis, trabecular bone score and 3D-DXA softwares. Secondary outcomes will include anthropometry, body composition, physical fitness, physical activity, calcium and vitamin D intake, blood samples, quality of life and mental health.
DISCUSSION


Whether a simple, feasible and short in duration exercise programme can improve bone health has not been examined in paediatric cancer survivors. This article describes the design, rationale and methods of a study intended to test the effect of a rigorous online exercise programme on bone health in paediatric cancer survivors. If successful, the iBoneFIT study will contribute to decrease chronic health conditions in this population and will have a positive impact in the society.
TRIAL REGISTRATION


Prospectively registered in isrctn.com: isrctn61195625 . Registered 2 April 2020.",2020,"Whether a simple, feasible and short in duration exercise programme can improve bone health has not been examined in paediatric cancer survivors.","['paediatric cancer survivors', 'paediatric cancer survivors (iBoneFIT', '116 participants aged 6 to 18\u2009years']","['online exercise programme and diet counselling on calcium and vitamin D', 'online exercise programme', 'radiotherapy, chemotherapy', 'diet counselling', 'rigorous online exercise programme']","['bone health', 'anthropometry, body composition, physical fitness, physical activity, calcium and vitamin D intake, blood samples, quality of life and mental health', 'body composition, physical fitness, physical activity, calcium intake, vitamin D, blood samples quality of life and mental health', 'dual energy X-ray absorptiometry (DXA) and the hip structural analysis, trabecular bone score and 3D-DXA softwares']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0564439', 'cui_str': 'Vitamin D intake'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0204514', 'cui_str': 'Structural analysis'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037585', 'cui_str': 'Software'}]",,0.179983,"Whether a simple, feasible and short in duration exercise programme can improve bone health has not been examined in paediatric cancer survivors.","[{'ForeName': 'Jose J', 'Initials': 'JJ', 'LastName': 'Gil-Cosano', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, 18071, Granada, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Ubago-Guisado', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, 18071, Granada, Spain.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Sánchez', 'Affiliation': 'Andalusian School of Health (EASP), Granada, Spain.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Ortega-Acosta', 'Affiliation': 'Servicio de Pediatría y Oncohematología Pediátricas, Hospital Universitario Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Mateos', 'Affiliation': 'Pediatric Oncology Unit, Department of Pediatrics, Reina Sofia University Hospital, Córdoba, Spain.'}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'Benito-Bernal', 'Affiliation': 'Hospital Infantil Universitario Niño Jesús, Madrid, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Llorente-Cantarero', 'Affiliation': 'Maimonides Institute for Research in Biomedicine of Cordoba (IMIBIC), Córdoba, Spain.'}, {'ForeName': 'Francisco B', 'Initials': 'FB', 'LastName': 'Ortega', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, 18071, Granada, Spain.'}, {'ForeName': 'Jonatan R', 'Initials': 'JR', 'LastName': 'Ruiz', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, 18071, Granada, Spain.'}, {'ForeName': 'Idoia', 'Initials': 'I', 'LastName': 'Labayen', 'Affiliation': ""Institute for Innovation and Sustainable Development in Food Chain (IS-FOOD), Navarra's Health Research Institute (IdiSNA), Department of Health Sciences, Public University of Navarra, Calle Tajonar 22, 31006, Pamplona, Navarra, Spain.""}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Martinez-Vizcaino', 'Affiliation': 'Universidad de Castilla-La Mancha, Health and Social Research Center, Cuenca, Spain.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Vlachopoulos', 'Affiliation': ""Children's Health and Exercise Research Centre, Sport and Health Sciences, University of Exeter, Exeter, UK.""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Arroyo-Morales', 'Affiliation': 'Biohealth Research Institute in Granada (ibs.GRANADA), E-18012, Granada, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Muñoz-Torres', 'Affiliation': 'Bone Metabolic Unit, Endocrinology and Nutrition Division, Hospital Universitario San Cecilio, Instituto de Investigación Biosanitaria de Granada (Ibs.GRANADA), Granada, Spain.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Pascual-Gázquez', 'Affiliation': 'Servicio de Pediatría y Oncohematología Pediátricas, Hospital Universitario Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Vicho-González', 'Affiliation': 'Pediatric Oncology Unit, Department of Pediatrics, Reina Sofia University Hospital, Córdoba, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Gracia-Marco', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, 18071, Granada, Spain. lgracia@ugr.es.'}]",BMC public health,['10.1186/s12889-020-09607-3']
1981,33032566,A protocol for a randomized controlled trial investigating the safety and cost-effectiveness of outpatient total hip arthroplasty.,"BACKGROUND


A significant proportion of the overall cost of total hip arthroplasty (THA) results from the inpatient hospital stay following the procedure. Considering the substantial and increasing number of these procedures performed annually, shifting to an outpatient model of care where the patient is discharged home the same day as their surgery represents a potential for significant cost savings. The potential significant impact of an outpatient care model on constrained healthcare budgets and lack of high-quality evidence regarding its effectiveness warrants a rigorous comparative trial. The purpose of this prospective, randomized controlled trial is to evaluate outpatient care pathways for THA. Specifically, our objectives are to compare the rate of serious adverse events and estimate the cost-effectiveness of outpatient compared to standard inpatient THA.
METHODS


We will include patients undergoing primary THA whom have an American Society of Anaesthetists status equal to or less than three, live within a 60-min driving distance of the institution and have an adult to accompany them home postoperatively and stay with them overnight. Consenting patients will be randomized to be discharged on the same day as surgery, as outpatients, or as inpatients according to standard of care (minimum of one night in hospital) using a modified Zelen consent model. The primary outcome measure is the incidence of serious adverse events at 30 days postoperative. Participants and their caregivers will complete secondary outcomes measures at each follow-up visit including patient-reported outcome measures and self-reported cost questionnaires.
DISCUSSION


This protocol is the first randomized trial to use blinding to evaluate outpatient THA compared to standard overnight stay and first to prospectively perform a full economic evaluation. It is also the first adequately powered trial to prospectively assess the safety of outpatient THA. Successful completion of this study could have the potential to provide clinical evidence for the role of outpatient THA in current practice.
TRIAL REGISTRATION


This study was retrospectively registered on ClinicalTrials.gov ( NCT03026764 ) on March 9th, 2016.",2020,This protocol is the first randomized trial to use blinding to evaluate outpatient THA compared to standard overnight stay and first to prospectively perform a full economic evaluation.,"['patients undergoing primary THA whom have an American Society of Anaesthetists status equal to or less than three, live within a 60-min driving distance of the institution and have an adult to accompany them home postoperatively and stay with them overnight', 'Consenting patients']",['outpatient total hip arthroplasty'],"['incidence of serious adverse events', 'self-reported cost questionnaires', 'safety and cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0997082,This protocol is the first randomized trial to use blinding to evaluate outpatient THA compared to standard overnight stay and first to prospectively perform a full economic evaluation.,"[{'ForeName': 'Bryn O', 'Initials': 'BO', 'LastName': 'Zomar', 'Affiliation': 'Faculty of Health Sciences, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Jacquelyn D', 'Initials': 'JD', 'LastName': 'Marsh', 'Affiliation': 'Faculty of Health Sciences, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Lanting', 'Affiliation': 'Bone and Joint Institute, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Dianne M', 'Initials': 'DM', 'LastName': 'Bryant', 'Affiliation': 'Faculty of Health Sciences, University of Western Ontario, London, ON, Canada. Dianne.bryant@uwo.ca.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03699-z']
1982,33032585,The effect of curcumin ointment on knee pain in older adults with osteoarthritis: a randomized placebo trial.,"BACKGROUND


Some studies have shown the effect of oral administration of curcumin on knee pain. However, limited studies are available on the effect of topical curcumin. This study aimed to investigate the effect of curcumin ointment on knee pain in older adults with osteoarthritis.
METHODS


This double-blind randomized placebo trial was conducted on 72 older adults with knee pain associated with osteoarthritis. The subjects were randomly assigned into an intervention and a placebo group to apply either curcumin 5% ointment or Vaseline ointment twice daily for 6 weeks. Using a Visual Analog Scale, the severity of knee pain was measured at the beginning of the study, at the end of the fourth and sixth week. Data were analyzed using descriptive and inferential methods.
RESULTS


The mean baseline knee pain intensity was not significantly different between the two groups (P = 0.15). The mean pain intensity was significantly lower in the intervention group than in the placebo group at the third measurement (P = 0.02). The repeated-measures analysis showed that over time, the curcumin significantly decreased the mean pain intensity in the intervention group (P = 0.001). The mixed model showed an absolute difference of 1.133 (i.e. 11.33 mm) score which signifies a medium effect size and that the patient in the intervention group achieved the minimal clinically important difference.
CONCLUSION


Topical administration of curcumin 5% ointment can significantly reduce knee pain in older adults with knee osteoarthritis. Curcumin ointment can be used as an alternative treatment in older adults with knee pain associated with osteoarthritis.
TRIAL REGISTRATION


Retrospectively registered in the Iranian Registry of Clinical Trials (IRCT) (IRCT20100403003618N6, 2019-03-08), https://en.irct.ir/trial/37155.",2020,The mean pain intensity was significantly lower in the intervention group than in the placebo group at the third measurement (P = 0.02).,"['older adults with knee pain associated with osteoarthritis', 'older adults with knee osteoarthritis', '72 older adults with knee pain associated with osteoarthritis', 'older adults with osteoarthritis']","['curcumin ointment', 'curcumin', 'placebo', 'Curcumin ointment', 'curcumin 5% ointment or Vaseline ointment']","['knee pain', 'mean baseline knee pain intensity', 'mean pain intensity', 'Visual Analog Scale, the severity of knee pain']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0728774', 'cui_str': 'Vaseline'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",72.0,0.228695,The mean pain intensity was significantly lower in the intervention group than in the placebo group at the third measurement (P = 0.02).,"[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Jamali', 'Affiliation': 'Trauma Nursing research Center, Faculty of Nursing and Midwifery, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Adib-Hajbaghery', 'Affiliation': 'Trauma Nursing research Center, Faculty of Nursing and Midwifery, Kashan University of Medical Sciences, Kashan, Iran. adib1344@yahoo.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Soleimani', 'Affiliation': 'Internal Medicine Department, Kashan University of Medical Sciences, Kashan, Iran.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-03105-0']
1983,33007780,Intranasal fluticasone furoate in pediatric allergic rhinitis: randomized controlled study.,"BACKGROUND


Intranasal corticosteroids are the most efficacious anti-inflammatory medications for allergic rhinitis (AR). However, the efficacy and safety of intranasal corticosteroids in children have not yet been subject to specific research in China. The aim of this study was to investigate the efficacy and safety of fluticasone furoate nasal spray (FFNS) in a Chinese pediatric population.
METHODS


In this phase 4 randomized, double-blind, placebo-controlled, multicenter study, pediatric AR patients aged 2-12 years were randomized 1:1:1, receiving either FFNS 55 µg or 110 µg or placebo. Electronic diary cards were completed to record symptoms, rescue medication use, and treatment compliance. Anterior rhinoscopy and overall response to therapy were evaluated and recorded.
RESULTS


Patients treated with FFNS at either dose experienced a significantly greater reduction in daily reflective total nasal symptom score compared with placebo. This was maintained in a younger subset of patients (2-6 years). Drug-related adverse events occurred in <20% of patients in all groups. FFNS was well tolerated at both doses.
CONCLUSIONS


This study demonstrates favorable efficacy and safety profiles for FFNS 55 µg or 110 µg in Chinese pediatric populations (2-12 years), supporting its use in clinical treatment for AR children, including younger children aged 2-6 years.
IMPACT


The aim of this study was to investigate the efficacy and safety of intranasal fluticasone furoate in Chinese pediatric allergic rhinitis. This research not only addresses the deficiency in efficacy and safety data for intranasal corticosteroids in very young patients (aged 2-6 years) worldwide but also demonstrates that fluticasone furoate nasal spray shows a favorable benefit/risk profile at different dose levels. Our data will be of interest to the broad readership of Pediatric Research and will positively contribute to the dialog regarding the treatment of allergic rhinitis in children aged 2-6 years.",2020,"RESULTS


Patients treated with FFNS at either dose experienced a significantly greater reduction in daily reflective total nasal symptom score compared with placebo.","['Chinese pediatric allergic rhinitis', '55 or 110\u2009µg in Chinese pediatric populations (2-12 years', 'pediatric AR patients aged 2-12 years', 'younger children aged 2-6 years', 'Chinese pediatric population', 'very young patients (aged 2-6 years', 'children aged 2-6 years', 'pediatric allergic rhinitis']","['intranasal corticosteroids', 'fluticasone furoate nasal spray (FFNS', 'intranasal fluticasone furoate', 'FFNS', 'placebo', 'Intranasal fluticasone furoate', 'fluticasone furoate nasal spray', 'FFNS 55 or 110\u2009µg or placebo']","['efficacy and safety', 'daily reflective total nasal symptom score', 'adverse events']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.197133,"RESULTS


Patients treated with FFNS at either dose experienced a significantly greater reduction in daily reflective total nasal symptom score compared with placebo.","[{'ForeName': 'Yamei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Otolaryngology, Head and Neck Surgery, Beijing Children's Hospital, Capital Medical University, Beijing, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wei', 'Affiliation': ""Department of Otolaryngology, The Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Bobei', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Otolaryngology, The Second Affiliated Hospital, Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Otolaryngology, Head and Neck Surgery, Children's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Xianyang', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, The First Affiliated Hospital, Medical College, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Xianming', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Otorhinolaryngology, Fuzhou General Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'Mingliang', 'Initials': 'M', 'LastName': 'Xiang', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Otolaryngology, Shenzhen Children's Hospital, Shenzhen, Guangdong, China.""}, {'ForeName': 'Sijun', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ""Department of Otolaryngology, and Head and Neck Surgery, Hunan Children's Hospital, Changsha, Hunan, China.""}, {'ForeName': 'Xuping', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': ""Department of Otolaryngology, Head and Neck Surgery, Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University, Changsha, Hunan, China.""}, {'ForeName': 'Xinmin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Otorhinolaryngology, Head and Neck Surgery, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': ""Department of Otolaryngology, Head and Neck Surgery, The Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Shuifang', 'Initials': 'S', 'LastName': 'Xiao', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Shanxi Children's Hospital, Taiyuan, Shanxi, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Department of Otorhinolaryngology & Clinical Allergy Center, The First Affiliated Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': ""Department of Otolaryngology, The Children's Hospital of Chongqing Medical University, Chongqing, China. yaohongbing@163.net.""}]",Pediatric research,['10.1038/s41390-020-01180-0']
1984,33008855,"Integrating Calcium Into Antenatal Iron-Folic Acid Supplementation in Ethiopia: Women's Experiences, Perceptions of Acceptability, and Strategies to Support Calcium Supplement Adherence.","Recommendations for antenatal calcium supplementation to prevent preeclampsia could substantially reduce maternal mortality, but adherence to multiple daily doses may constrain effectiveness. World Health Organization guidelines recommend 3 daily calcium supplements (1.5-2 g/d), taken separately from 1 iron-folic acid (IFA) supplement; however, limited data suggest lower calcium doses may also be effective. We conducted mixed-methods household trials to identify strategies for supporting adherence and integrating calcium into antenatal IFA supplementation programming in Ethiopia. Participants were randomly assigned to 3 regimens varying in dose and timing and were later given a choice of regimens. Semistructured interviews conducted over 6 weeks explored acceptability, barriers, and facilitators and offered opportunities to choose calcium pill type. Interviews were transcribed, translated, and analyzed thematically. Calcium adherence was measured using medication event monitoring. All participants (N=48) agreed to try supplementation. Adherence barriers included forgetting to take pills when busy or travelling and perceived side effects. Midday doses were the most challenging because of farming, market, and social events; women avoided taking supplements in public due to fear of being perceived as HIV positive. Social support from families, visual reminders, and anticipated benefits motivated adherence. More participants (75%) selected chewable versus conventional supplements due to organoleptic properties, but this preference declined over time. Adherence rates did not substantially differ across regimens with 2 (81.1%), 3 (83.4%), or 4 (77.1%) pill-taking events. Women indicated that the 2-event regimen was more acceptable than 3- and 4-event regimens, but this acceptability was not associated with higher adherence. Consequently, mean daily calcium consumption (811.3 mg) was lower than for 3-event (1,251.1 mg) and 4-event (1,156.4 mg) regimens. Integrating calcium into antenatal IFA supplementation is acceptable to Ethiopian women, with a 3-event regimen yielding the highest consumption rates. Despite women experiencing challenges with midday dosing and stigma, using simple home-based strategies and being counseled on the purpose of supplementation were more effective than reducing dosage for mitigating barriers and improving adherence.",2020,"Adherence rates did not substantially differ across regimens with 2 (81.1%), 3 (83.4%), or 4 (77.1%) pill-taking events.","['All participants (N=48) agreed to try supplementation', 'Ethiopia']",['Integrating Calcium Into Antenatal Iron-Folic Acid Supplementation'],"['Calcium adherence', 'Adherence rates', 'mean daily calcium consumption', 'maternal mortality']","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0357067', 'cui_str': 'Folic acid- and iron-containing product'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}]",,0.0597183,"Adherence rates did not substantially differ across regimens with 2 (81.1%), 3 (83.4%), or 4 (77.1%) pill-taking events.","[{'ForeName': 'Gina C', 'Initials': 'GC', 'LastName': 'Klemm', 'Affiliation': 'Program in International Nutrition, Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Zewdie', 'Initials': 'Z', 'LastName': 'Birhanu', 'Affiliation': 'Faculty of Public Health, Department of Health, Behavior and Society, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Ortolano', 'Affiliation': 'Program in International Nutrition, Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Yohannes', 'Initials': 'Y', 'LastName': 'Kebede', 'Affiliation': 'Faculty of Public Health, Department of Health, Behavior and Society, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Martin', 'Affiliation': 'Program in International Nutrition, Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Girma', 'Initials': 'G', 'LastName': 'Mamo', 'Affiliation': 'Ethiopia-Canada Cooperation Office, Nutrition International, Addis Ababa, Ethiopia.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Dickin', 'Affiliation': 'Program in International Nutrition, Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA. kld12@cornell.edu.'}]","Global health, science and practice",['10.9745/GHSP-D-20-00008']
1985,33010183,Acute effects of aerobic exercise and relaxation training on fatigue in breast cancer survivors: A feasibility trial.,"OBJECTIVE


This three-armed randomized controlled feasibility trial tested the acceptability and acute effects of aerobic exercise and technology-guided mindfulness training (relative to standalone interventions) on cancer-related fatigue among breast cancer survivors (BCS).
METHODS


BCS recruited from Central Illinois completed pre- and post-testing using established measures and were randomized to one of three groups (combined aerobic exercise with guided-mindfulness relaxation, aerobic exercise only, and relaxation only), conducted in three 90 min sessions over the course of 7 days in a fitness room and research office on a university campus.
RESULTS


We enrolled 40 BCS (M age  = 57.33 ± 8.75), M BMI  = 27.38 ± 5.27, M fatigue  = 4.56 ± 1.81 as measured by the Piper Fatigue Scale. More favorable post-intervention evaluations were reported by the combined group, compared to aerobic exercise or relaxation only (p < 0.05). Reductions in fatigue favoring the combined group (p = 0.05) showed a modest effect size (Cohen's d = 0.91) compared to aerobic exercise only.
CONCLUSIONS


These findings provide preliminary evidence for the feasibility of combining evidence-based techniques to address fatigue among BCS. The combined approach, incorporating mobile health technology, presents an efficacious and well-received design. If replicated in longer trials, the approach could provide a promising opportunity to deliver broad-reaching interventions for improved outcomes in BCS. Preregistered-ClinicalTrials NCT03702712.",2020,"More favorable post-intervention evaluations were reported by the combined group, compared to aerobic exercise or relaxation only (p < 0.05).","['cancer-related fatigue among breast cancer survivors (BCS', 'We enrolled 40 BCS (M age  = 57.33 ± 8.75), M BMI  = 27.38 ± 5.27, M fatigue  = 4.56 ± 1.81 as measured by the Piper Fatigue Scale', 'BCS recruited from Central Illinois completed pre-and post-testing using established measures', 'Breast Cancer Survivors']","['aerobic exercise with guided-mindfulness relaxation, aerobic exercise only, relaxation only', 'Aerobic Exercise and Relaxation Training', 'aerobic exercise and technology-guided mindfulness training (relative to standalone interventions']","['Reductions in fatigue', 'aerobic exercise or relaxation']","[{'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517881', 'cui_str': '8.75'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C4517763', 'cui_str': '4.56'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]",40.0,0.149055,"More favorable post-intervention evaluations were reported by the combined group, compared to aerobic exercise or relaxation only (p < 0.05).","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': 'Department of Kinesiology & Community Health, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}, {'ForeName': 'Wendy A', 'Initials': 'WA', 'LastName': 'Rogers', 'Affiliation': 'Department of Kinesiology & Community Health, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Petruzzello', 'Affiliation': 'Department of Kinesiology & Community Health, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Trinh', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Mullen', 'Affiliation': 'Department of Kinesiology & Community Health, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}]",Psycho-oncology,['10.1002/pon.5561']
1986,33010473,Patient navigation among recently hospitalized smokers to promote tobacco treatment: Results from a randomized exploratory pilot study.,"INTRODUCTION


Adding screening for health-related social needs to tobacco treatment interventions initiated during hospitalizations may improve intervention effectiveness among vulnerable populations. Our objective was to examine the effect the acceptability and feasibility of a intervention in which a patient navigator screens for and addresses social needs to increase receipt of smoking cessation medication among recently hospitalized smokers at a safety-net hospital.
METHODS


In a two-group randomized exploratory pilot study, we assigned hospitalized smokers to either the Enhanced Traditional Control (ETC) group (list of smoking cessation resources) or ETC + Patient Navigation (up to 10 h of navigation over a 3-month period, in which a navigator screens for and addresses health-related social needs). We assessed socio-demographics, smoking-related variables, and process data.
RESULTS


Of 171 individuals screened, 44 (26%) were enrolled. Participants (mean age = 54.9 years, 61.4% non-Hispanic black, 68.2% high school education or less) smoked a mean of 11.4 cigarettes/day. 20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group. 11 participants (47.8%) in the ETC + Patient Navigation group received the minimum intervention dose (completion of the social needs screener and at least one counseling session). Barriers to navigation were participants' medical illness and difficulty connecting with participants.
CONCLUSIONS


Although nearly half of hospitalized smokers receiving support from a patient navigator received a prescription for a smoking cessation medication, the percentage did not differ by study arm. Refinement of the protocol to coordinate with hospital-wide tobacco treatment and social needs screening initiatives is needed.",2020,"20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group.","['54.9\xa0years, 61.4% non-Hispanic black, 68.2% high school education or less) smoked a mean of 11.4 cigarettes/day', 'Participants (mean age\xa0', '20 participants', 'Of 171 individuals screened, 44 (26%) were enrolled']","['ETC\xa0+\xa0Patient Navigation group', 'minimum intervention dose (completion of the social needs screener and at least one counseling session', 'Enhanced Traditional Control (ETC) group (list of smoking cessation resources) or ETC\xa0+\xa0Patient Navigation (up to 10\xa0h of navigation']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0547043', 'cui_str': 'Up'}]",[],,0.0505863,"20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group.","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Quintiliani', 'Affiliation': 'Boston University, School of Medicine, Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States. Electronic address: Lmquinti@bu.edu.'}, {'ForeName': 'Hasmeena', 'Initials': 'H', 'LastName': 'Kathuria', 'Affiliation': 'Boston University, School of Medicine, The Pulmonary Center, Boston Medical Center, Section of Pulmonary, Allergy, Sleep & Critical Care Medicine, 72 East Concord St., Boston, MA 02118, United States.'}, {'ForeName': 'Ve', 'Initials': 'V', 'LastName': 'Truong', 'Affiliation': 'Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Murillo', 'Affiliation': 'Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Borrelli', 'Affiliation': 'Boston University, Henry M. Goldman School of Dental Medicine, Center for Behavioral Science Research, 560 Harrison Ave., Boston, MA 02118, United States.'}, {'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Xuan', 'Affiliation': 'Boston University, School of Public Health, 801 Massachusetts Ave., Crosstown CT453, Boston, MA 02118, United States.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Lasser', 'Affiliation': 'Boston University, School of Medicine, Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106659']
1987,33010491,The incidence of persistent postoperative opioid use among U.S. veterans: A national study to identify risk factors.,"OBJECTIVE


To calculate the incidence and identify the predictors of persistent postoperative opioid use at different postoperative days.
BACKGROUND DATA


A subset of surgical patients continues to use long-term opioids. The importance of the risk factors at different postoperative days is not known.
DESIGN


A historical cohort.
SETTING


Postoperative period.
PATIENTS


Opioid-naive U.S. veterans.
INTERVENTIONS


The surgical group had any one of 19 common invasive procedures. The control group is a 10% random sample. Each control was randomly assigned a surgery date.
MEASUREMENTS


The outcomes were the presence of persistent opioid use as determined by continued filling of prescriptions for opioids on postoperative days 90, 180, 270, and 365.
MAIN RESULTS


A total of 183,430 distinct surgical cases and 1,318,894 controls were identified. 1.0% of the surgical patients were using opioids at 90 days, 0.6% at 180 days, 0.4% at 270 days, and 0.1% at 365 days after the surgery. Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls. In risk factor analysis, being male and single were associated with persistent opioid use at earlier time points (90 and 180 days), while hepatitis C and preoperative benzodiazepine use were associated with persistent opioid use at later time points (270 and 365 days).
CONCLUSIONS


Many surgeries or invasive procedures are associated with an increased risk of persistent postoperative opioid use. The postoperative period is dynamic and the risk factors change with time.",2020,"Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls.","['Opioid-naive U.S. veterans', 'U.S. veterans', '183,430 distinct surgical cases and 1,318,894 controls were identified']",[],['postoperative persistent opioid use'],"[{'cui': 'C1739422', 'cui_str': 'Opioid naive'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",183430.0,0.0682083,"Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls.","[{'ForeName': 'Khodadad', 'Initials': 'K', 'LastName': 'Namiranian', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America; Department of Anesthesiology, University of Maryland, Baltimore, MD, United States of America; VA Central California Health Care System, Fresno, CA, United States of America. Electronic address: khodadad.x.namiranian@kp.org.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Siglin', 'Affiliation': 'School of Medicine, University of Maryland, Baltimore, MD, United States of America.'}, {'ForeName': 'John David', 'Initials': 'JD', 'LastName': 'Sorkin', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America; Baltimore VA Medical Center Geriatric Research, Education and Clinical Center, VA Maryland Health Care System, Baltimore, MD, United States of America; Division of Gerontology and Geriatric Medicine, University of Maryland, Baltimore, MD, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110079']
1988,33010590,Plantar pressure distribution and wearing characteristics of three forefoot offloading shoes in healthy adult subjects.,"Forefoot offloading shoes are used to reduce pressure on specific regions of the foot. Aim of the pressure reduction is to aid healing of the soft and bony tissues and prevent complications by treating foot disorders. A great variety of forefoot offloading shoes are available. In a first step to investigate the appropriate use of these footwear in orthopedic settings, we studied plantar pressure distribution and wearing characteristics of three forefoot offloading shoes namely the Mailand, OrthoWedge and Podalux in a healthy population. Twenty subjects walked in a randomized order wearing three forefoot offloading shoes and a reference shoe for six minutes. The Pedar system was used to measure the pressure in 7 regions. Peak pressure and pressure time integral were analyzed as measures of pressure distribution. Furthermore, wearing characteristics were addressed using a Numeric Rating Scale. Pressure distribution and wearing characteristics of the forefoot offloading shoes were compared to a reference shoe. The Mailand and OrthoWedge shoes significantly reduced peak pressure with more than 80% under the hallux and more than 45% under MTH1 (p<.001). The Podalux did not show significant peak pressure reduction under the forefoot compared to the reference shoe. Under the lesser toes, the MTH4-5 region and heel region the Podalux shoe showed even a significant increase in peak pressure (p=.001). Looking at wearing characteristics, the Podalux and reference shoe scored significantly better than the other two forefoot offloading shoes (p<.01). In this study the differences between different forefoot offloading shoes was assessed. The Mailand and OrthoWedge shoes gave the best pressure reduction in the forefoot but are less comfortable in use. The Podalux rocker shoe showed opposite results. Next step is a patient study to compare our results in a patient population.",2020,"Looking at wearing characteristics, the Podalux and reference shoe scored significantly better than the other two forefoot offloading shoes (p<.01).","['Twenty subjects walked', 'healthy adult subjects']",[],"['Numeric Rating Scale. Pressure distribution and wearing characteristics of the forefoot offloading shoes', 'Plantar pressure distribution and wearing characteristics', 'Peak pressure and pressure time integral', 'peak pressure reduction', 'peak pressure']","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",20.0,0.0330946,"Looking at wearing characteristics, the Podalux and reference shoe scored significantly better than the other two forefoot offloading shoes (p<.01).","[{'ForeName': 'M C H W', 'Initials': 'MCHW', 'LastName': 'Fuchs', 'Affiliation': 'Department of Orthopaedic Surgery, Catharina Hospital Eindhoven, Postbus 1350, 5602 ZA Eindhoven, The Netherlands; Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands. Electronic address: thijn.fuchs@catharinaziekenhuis.nl.'}, {'ForeName': 'M M N', 'Initials': 'MMN', 'LastName': 'Hermans', 'Affiliation': 'Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands.'}, {'ForeName': 'H J J', 'Initials': 'HJJ', 'LastName': 'Kars', 'Affiliation': 'Fontys Hogeschool Eindhoven, Allied Health Professions, Dominee Theodor Fliednerstraat 2, 5631 BN Eindhoven, The Netherlands.'}, {'ForeName': 'J G E', 'Initials': 'JGE', 'LastName': 'Hendriks', 'Affiliation': 'Department of Orthopaedic Surgery, Catharina Hospital Eindhoven, Postbus 1350, 5602 ZA Eindhoven, The Netherlands; Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'van der Steen', 'Affiliation': 'Department of Orthopaedic Surgery, Catharina Hospital Eindhoven, Postbus 1350, 5602 ZA Eindhoven, The Netherlands; Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands.'}]","Foot (Edinburgh, Scotland)",['10.1016/j.foot.2020.101744']
1989,33010649,"The effect of a stress ball on stress, vital signs and patient comfort in hemodialysis patients: A randomized controlled trial.","OBJECTIVE


In this study, an investigation was made of the effect of the use of a stress ball, a method of distraction-attracting the attention elsewhere - on stress, vital signs andcomfort levels in hemodialysis patients.
METHODS


This randomized, controlled experimental study, between July 2019 and September 2019 was carried out in a dialysis unit in the inner regions of Turkey. The study was conducted with 45 patients (23 experiments, 22 controls) who were receiving hemodialysis treatment. The experimental group were asked to squeeze a stress ball for approximately 10-15 min throughout eight successive dialysis sessions. The data were obtained with an Individual Description Form, the Distress Thermometer and the Hemodialysis Comfort Scale.
RESULTS


At the end of the study, no significant difference was found in the vital signs and comfort levels of the experimental and control groups (p > 0.05). However, while the stress score of the experimental group decreased significantly, the stress score of the control groups increased (p < 0.05).
CONCLUSION


This study shows that although the use of the stress ball did not affect vital signs and comfort in hemodialysis patients, it had a positive effect on stress.",2020,"At the end of the study, no significant difference was found in the vital signs and comfort levels of the experimental and control groups (p > 0.05).","['45 patients (23 experiments, 22 controls) who were receiving hemodialysis treatment', 'hemodialysis patients', 'between July 2019 and September 2019 was carried out in a dialysis unit in the inner regions of Turkey']",[],"['stress score', 'vital signs and comfort levels', 'stress, vital signs and patient comfort']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1629858', 'cui_str': 'Dialysis unit'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]",[],"[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}]",,0.0236922,"At the end of the study, no significant difference was found in the vital signs and comfort levels of the experimental and control groups (p > 0.05).","[{'ForeName': 'Kadriye Sayin', 'Initials': 'KS', 'LastName': 'Kasar', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Aksaray University, Aksaray, Turkey. Electronic address: kadriyekasar@aksaray.edu.tr.'}, {'ForeName': 'Saadet', 'Initials': 'S', 'LastName': 'Erzincanli', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Aksaray University, Aksaray, Turkey. Electronic address: saadeterzincanli@hotmail.com.'}, {'ForeName': 'Nesat Tolga', 'Initials': 'NT', 'LastName': 'Akbas', 'Affiliation': 'Dialysis Unit, Training and Research Hospital, Aksaray University, Aksaray, Turkey. Electronic address: takbas@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101243']
1990,33016783,"A randomized, double-blind, parallel pharmacokinetic study comparing the trastuzumab biosimilar candidate, AryoTrust®, and reference trastuzumab in healthy subjects.","BACKGROUND


AryoTrust® (AryoGen Pharmed Co., Iran) is a biosimilar candidate for the EU-sourced reference trastuzumab, Herceptin®. This study was designed to evaluate the bioequivalence between AryoTrust® and Herceptin®.
RESEARCH DESIGN AND METHODS


In this double-blind, parallel study, 60 healthy male subjects were randomized 1:1 to receive a single dose of AryoTrust® or Herceptin® (6 mg/kg) as intravenous infusion. The primary endpoint of the study was the area under the concentration versus time to infinity (AUC 0-inf ), and the main secondary endpoints were maximum measured concentration (C max ), area under the concentration versus time from zero to the last quantifiable concentration time (AUC 0-last ), immunogenicity, and safety.
RESULTS


Sixty subjects were enrolled in the study and baseline demographics were similar between the two groups. The two groups demonstrated similar pharmacokinetic parameters and the 90% confidence interval (CI) for primary and secondary endpoints were within the bioequivalence acceptance range (80.00%-125.00%). No serious adverse event or immunogenicity was reported, and all of the adverse events reported were mild and similar between the two treatment groups.
CONCLUSION


AryoTrust® was well tolerated, had a similar safety profile to reference trastuzumab, and its pharmacokinetic bioequivalence was confirmed.
TRIAL REGISTRATION


The trial is registered at Indian Trials Registry (CTRI/2019/03/018218).",2020,"No serious adverse event or immunogenicity was reported, and all of the adverse events reported were mild and similar between the two treatment groups.
","['Sixty subjects', '60 healthy male subjects', 'Healthy Subjects']","['Trastuzumab Biosimilar Candidate, AryoTrust®, and Reference Trastuzumab', 'AryoTrust® or Herceptin®']","['serious adverse event or immunogenicity', 'adverse events', 'area under the concentration versus time to infinity (AUC 0-inf ), and the main secondary endpoints were maximum measured concentration (C max ), area under the concentration versus time from zero to the last quantifiable concentration time (AUC 0-last ), immunogenicity, and safety']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0338204', 'cui_str': 'Herceptin'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.452882,"No serious adverse event or immunogenicity was reported, and all of the adverse events reported were mild and similar between the two treatment groups.
","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Farmahini Farahani', 'Affiliation': 'CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences , Karaj, Iran.'}, {'ForeName': 'Parnian', 'Initials': 'P', 'LastName': 'Maghzi', 'Affiliation': 'CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences , Karaj, Iran.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Jafari Aryan', 'Affiliation': 'CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences , Karaj, Iran.'}, {'ForeName': 'Borna', 'Initials': 'B', 'LastName': 'Payandemehr', 'Affiliation': 'Experimental Medicine Research Center, Tehran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Mayur', 'Initials': 'M', 'LastName': 'Soni', 'Affiliation': 'Cliantha Research Limited, Cliantha Research Limited , Ahmedabad, Gujarat, India.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Azhdarzadeh', 'Affiliation': 'Biopharmaceutical Research Center, AryoGen Pharmed Inc., Alborz University of Medical Sciences , Karaj, Iran.'}]",Expert opinion on investigational drugs,['10.1080/13543784.2020.1831470']
1991,33011293,"An invited commentary on: ""A randomized controlled trial on irrigation of open appendectomy wound with gentamicin-saline solution versus saline solution for prevention of surgical site infection."" (Int J Surg 2020; 81:140-146).",,2020,,[],['gentamicin-saline solution versus saline solution'],[],[],"[{'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]",[],,0.233394,,"[{'ForeName': 'Maria Michela', 'Initials': 'MM', 'LastName': 'Chiarello', 'Affiliation': 'Department of Surgery, General Surgery Operative Unit, ""San Giovanni di Dio"" Hospital, Crotone, Italy. Electronic address: mikikr2001@gmail.com.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Brisinda', 'Affiliation': 'Department of Surgery, Catholic School of Medicine, ""Agostino Gemelli"" Hospital, Rome, Italy. Electronic address: gbrisin@tin.it.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.09.047']
1992,33011546,"Could ""triple-therapy"" considered as a novel-optimal treatment model for acute bipolar depression? A prospective real-world research in China.","BACKGROUND


Results of researches of bipolar depression treatment are inconsistent and to our knowledge, no study has previously revealed an optimal treatment model for bipolar depression in the real-world through a prospective way.
OBJECTIVE


To find out an optimal treatment model for bipolar depression in the real-world by evaluating the effect of different treatment models: monotherapy, double-therapy and triple-therapy.
DESIGN


and Intervention: This 12 or 16-week, multi-center, real-world clinical study was conducted at 15 study sites (inpatient or outpatient department) in West China and a total of 573 patients completed the follow-up. During the study weeks, all researchers could choose a most proper treatment model freely basing on the evaluation of patient's symptoms and complete the follow-up according to the procedure.
MAIN OUTCOMES AND MEASURES


The primary outcomes were baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) total score and the constituent ratio of effects. Total score change in Young Mania Rating Scale (YMRS) and Clinical Global Impression (CGI) from baseline to endpoint, treatment-emergent mania rate and severe adverse events rate were used as secondary outcomes.
RESULTS


During all study weeks, all the 3 groups showed a statistically significant improvement in MARDS, YMRS and CGI (P＜0.001), but the triple-therapy group showed much more effective in significant response and response rates at endpoint than double-therapy group and monotherapy group (P＜0.001) with lower treatment-emergent mania rates (P = 0.001). At week 4, mean scores of MARDS in triple-therapy group are statistically significant lower than monotherapy group (P = 0.013) and at the endpoint, mean scores of MARDS in triple-therapy group are statistically significant lower than both double-therapy and monotherapy groups (P = 0.011). The severe adverse events rates are rare in all the 3 groups at week 4 and endpoint, and the rate of dry mouth in triple-therapy group at week 4 is statistically significant lower than the other 2 groups (P = 0.002).
CONCLUSIONS


Triple-therapy is more effective in treating bipolar depression than double-therapy and monotherapy model with a lower risk of developing manic symptoms.
TRIAL REGISTRATION


Chinese Clinical Trial Registry. Identifier: ChiCTR1800019064.",2020,"During all study weeks, all the 3 groups showed a statistically significant improvement in MARDS, YMRS and CGI (P＜0.001), but the triple-therapy group showed much more effective in significant response and response rates at endpoint than double-therapy group and monotherapy group (P＜0.001) with lower treatment-emergent mania rates (P = 0.001).",['15 study sites (inpatient or outpatient department) in West China and a total of 573 patients completed the follow-up'],"['monotherapy, double-therapy and triple-therapy']","['severe adverse events rates', 'MARDS, YMRS and CGI', 'mean scores of MARDS', 'rate of dry mouth', 'baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) total score and the constituent ratio of effects', 'mania rate and severe adverse events rate', 'response and response rates', 'Total score change in Young Mania Rating Scale (YMRS) and Clinical Global Impression (CGI', 'mania rates']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205174', 'cui_str': 'Triple'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0338831', 'cui_str': 'Mania'}]",573.0,0.0263737,"During all study weeks, all the 3 groups showed a statistically significant improvement in MARDS, YMRS and CGI (P＜0.001), but the triple-therapy group showed much more effective in significant response and response rates at endpoint than double-therapy group and monotherapy group (P＜0.001) with lower treatment-emergent mania rates (P = 0.001).","[{'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Mental Health Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Sichuan Provincial Center for Mental Health, Psychosomatic Medical Center of Sichuan People's Hospital, China.""}, {'ForeName': 'Ruhan', 'Initials': 'R', 'LastName': 'A', 'Affiliation': 'Sleep Medicine Center of University of Electronic Science and Technology Hospital, China.'}, {'ForeName': 'Yuexin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Mental Health Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Xueli', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Mental Health Center, West China Hospital of Sichuan University, China. Electronic address: sunxueli2018@126.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.09.017']
1993,33018052,Closed-loop Electroencephalogram-based modulated audio to fall and deepen sleep faster.,"The transition from wake to sleep is a continuum that is well characterized by the electroencephalogram (EEG) power spectral ratio (ρ) between the beta (15 to 30 Hz) and theta (4 to 8 Hz) bands. From wake to sleep, the value of ρ gradually decreases.We have designed and implemented a single EEG-signal based closed-loop system that leverages ρ to modulate the volume of a pink-noise type of audio such that the volume becomes gradually softer as sleep initiates. A proof-of-concept trial was conducted with this system and it was found that using this concept resulted in a reduction of sleep latency and latency to deep sleep.",2020,A proof-of-concept trial was conducted with this system and it was found that using this concept resulted in a reduction of sleep latency and latency to deep sleep.,[],['Closed-loop Electroencephalogram-based modulated audio'],['sleep latency and latency to deep sleep'],[],"[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}]",,0.0164796,A proof-of-concept trial was conducted with this system and it was found that using this concept resulted in a reduction of sleep latency and latency to deep sleep.,"[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Garcia-Molina', 'Affiliation': ''}, {'ForeName': 'Boomika', 'Initials': 'B', 'LastName': 'Kalyan', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Aquino', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9175689']
1994,33018086,Sex Differences in Heart Rate Nonlinearity by Multifractal Multiscale Detrended Fluctuation Analysis.,"Recent developments of detrended fluctuation analysis (DFA) provide multifractal/multiscale (MFMS) descriptions of the heart rate self-similarity, a promising approach to cardiovascular complexity. However, it is unclear whether the MFMS DFA may also describe the nonlinear components of heart rate variability. Our aim is to define MFMS DFA indices for quantifying the short-term and long-term degree of the heart-rate nonlinearity and to apply these indices to detect possible sex-related differences.We recorded the inter-beat-interval (IBI) series in 42 male and in 42 female healthy participants sitting at rest for about 2 hours. For each series j, we generated 100 phase-randomized surrogate series. We applied the MFMS DFA to estimate the self-similarity coefficients α over scales τ between 8 and 512 s and moment orders q between -5 and +5, obtaining coefficients for the original series, α O,j  (q, τ), and for each surrogate, α i,j  (q, τ) with 1≤i≤100. We first evaluated π j (q, τ), percentile of α i,j  (q, τ) distribution in which was α O,j  (q, τ). Then we calculated the percentages of scales where π j (q, τ) was <5% for 8≤τ≤16 s (short-term nonlinearity index NL 1 (q)) and for 16≤τ≤512 s (long-term nonlinearity index NL 2 (q)). We found that NL 1 (q) was generally greater than 50% at all q≥0 but q=2 (i.e., moment order of the monofractal DFA), while at q<0 it was high in males only, with significant sex differences at q=-1 and q=-2. Results indicate that the multifractal DFA may highlight nonlinear heart-rate components at the short scales that are not revealed by the traditional monofractal DFA and that appear related to gender differences.Clinical Relevance- This supports the use of MFMS DFA to integrate the linear information from traditional spectral methods of heart rate variability in clinical studies aimed at improving the stratification of the cardiovascular risk.",2020,"Then we calculated the percentages of scales where π j (q, τ) was <5% for 8≤τ≤16 s (short-term nonlinearity index NL 1 (q)) and for 16≤τ≤512 s (long-term nonlinearity index NL 2 (q)).",['42 male and in 42 female healthy participants sitting at rest for about 2 hours'],"['Clinical Relevance', 'MFMS DFA']","['π j (q, τ), percentile of α i,j  (q, τ) distribution']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C1292425', 'cui_str': '2 hours'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]",42.0,0.0275659,"Then we calculated the percentages of scales where π j (q, τ) was <5% for 8≤τ≤16 s (short-term nonlinearity index NL 1 (q)) and for 16≤τ≤512 s (long-term nonlinearity index NL 2 (q)).","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Castiglioni', 'Affiliation': ''}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Lazzeroni', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Coruzzi', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Faini', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9176704']
1995,33018534,Modulatory Effects of Respiratory-Gated Auricular Vagal Nerve Stimulation on Cardiovagal Activity in Hypertension .,"The objective of this study was to determine potential effects of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) on cardiac autonomic activity in hypertensive patients.20 hypertensive subjects (57.3±6.2 years; 11 females, 9 males) were randomized to receive either active RAVANS at 25 Hz or sham stimulation for 5 consecutive days and were assessed 5 and 10 days later. Continuous electrocardiogram, pulse rate, and blood pressure signals were collected during 10-minute baseline, 30-minute stimulation, and 10-minute recovery periods for each session. LabChart was used to acquire and process heart rate variability and blood pressure indices. Percent changes of mean values during the recovery period were calculated comparing the final stimulation session and follow-up sessions to the first stimulation session. General linear models were applied to assess the effects of RAVANS on the variables evaluated, considering baseline values and sex as covariates in the models.We found that RAVANS increased high frequency (HF-HRV) power during recovery of the final stimulation session and both follow-up sessions in comparison to sham. RAVANS also lowered heart rate and increased average RR and root mean square of successive RR interval differences (RMSSD) during recovery on the final day of stimulation. No significant effects on blood pressure values were observed during these periods.These results suggest that RAVANS effectively stimulates cardiovagal activity in hypertension, with effects lasting up to 10 days. Future research incorporating larger sample sizes is needed to replicate the effects of RAVANS.Clinical Relevance- This research has implications for potential therapeutic effects of respiratory-gated tVNS on cardiovagal modulation in hypertensive patients.",2020,RAVANS also lowered heart rate and increased average RR and root mean square of successive RR interval differences (RMSSD) during recovery on the final day of stimulation.,"['hypertensive patients.20 hypertensive subjects (57.3±6.2 years; 11 females, 9 males', 'Hypertension ', 'hypertensive patients']","['Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS', 'Respiratory-Gated Auricular Vagal Nerve Stimulation', 'active RAVANS at 25 Hz or sham stimulation', 'respiratory-gated tVNS', 'RAVANS.Clinical Relevance']","['cardiac autonomic activity', 'heart rate and increased average RR and root mean square of successive RR interval differences (RMSSD', 'Cardiovagal Activity', 'blood pressure values', 'high frequency (HF-HRV', 'Continuous electrocardiogram, pulse rate, and blood pressure signals']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0199562', 'cui_str': 'Continuous electrocardiogram'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",,0.0436104,RAVANS also lowered heart rate and increased average RR and root mean square of successive RR interval differences (RMSSD) during recovery on the final day of stimulation.,"[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Staley', 'Affiliation': ''}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Garcia', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Stowell', 'Affiliation': ''}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Sclocco', 'Affiliation': ''}, {'ForeName': 'Harrison', 'Initials': 'H', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Napadow', 'Affiliation': ''}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Goldstein', 'Affiliation': ''}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Barbieri', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9175768']
1996,33017615,Effect of Intracavernosal Injection of Prostaglandin E1 on Duration and Rigidity of Erection in Patients With Vasculogenic Erectile Dysfunction: Is It Dose Dependent?,"OBJECTIVE


To assess if the effect of intracavernosal injection of prostaglandin E1 (PGE1) on duration and rigidity of erection is dose dependent in patients with different types of vasculogenic erectile dysfunction (ED)?
METHODS


A hundred patients with ED were assigned into 4 groups (n = 25/each); group (A) patients with arteriogenic ED, group (B) patients with veno-occlusive ED, group (C) patients with mixed (arteriogenic and veno-occlusive) ED, and group (D) patients who have only psychogenic ED (control). After intracavernosal injection of PGE1, patients were assessed using penile Doppler ultrasonography and erection hardness score together with calculation of erection duration. The starting dose of PGE1 was 5 μg which was increased to 10 µg and 20 µg as a maximal dose when needed.
RESULTS


The mean PSV of patients in groups A, B, C, and D were 24.38 ± 3.3, 37.74 ± 8.28, 22.24 ± 3.85, and 47.76 ± 6.27, respectively. In group D, 88% have achieved the best response at dose of 5 µg while 5.3%, 21.7%, and 0% have achieved the best response at dose of 5 µg in groups A, B, and C, respectively (P < .05 for each). The rest of patients have required either 10 or 20µg to achieve the best response. Patients in group C have required the highest dose of PGE1 to achieve the best response (P < .05).
CONCLUSION


Intracavernosal injection of PGE1 in escalating doses have improved the rigidity and duration of erection in patients with different types of vasculogenic ED. Patients with mixed arteriogenic and veno-occlusive ED have required the highest dose of PGE1 to achieve the best response.",2020,"Patients in group C have required the highest dose of PGE1 to achieve the best response (p<0.05).
","['Patients with mixed arteriogenic and veno-occlusive ED', 'patients with different types of vasculogenic ED', 'Patients with Vasculogenic Erectile Dysfunction', 'A hundred patients with ED were assigned into 4 groups (n=25/each); group (A) patients with arteriogenic ED, group (B) patients with veno-occlusive ED, group (C) patients with mixed (arteriogenic and veno-occlusive) ED and group (D) patients who have only psychogenic ED (control', 'patients with different types of vasculogenic erectile dysfunction (ED']","['intracavernosal injection (ICI) of prostaglandin E1 (PGE1', 'Intracavernosal Injection of Prostaglandin E1']","['Duration and Rigidity of Erection', 'mean PSV', 'duration and rigidity of erection', 'penile doppler ultrasonography and erection hardness score', 'rigidity and duration of erection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0948238', 'cui_str': 'Psychogenic erectile dysfunction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1297890', 'cui_str': 'Injection of prostaglandin'}, {'cui': 'C0002335', 'cui_str': 'Alprostadil'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C2960554', 'cui_str': 'Erection hardness score'}]",,0.0311077,"Patients in group C have required the highest dose of PGE1 to achieve the best response (p<0.05).
","[{'ForeName': 'Mahmoud A', 'Initials': 'MA', 'LastName': 'Bassiem', 'Affiliation': 'Department of Urology, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Iman Y', 'Initials': 'IY', 'LastName': 'Ismail', 'Affiliation': 'Department of Urology, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Tarek A', 'Initials': 'TA', 'LastName': 'Salem', 'Affiliation': 'Department of Urology, Helwan University.'}, {'ForeName': 'Ahmed I', 'Initials': 'AI', 'LastName': 'El-Sakka', 'Affiliation': 'Department of Urology, Suez Canal University, Ismailia, Egypt. Electronic address: aielsakka@yahoo.com.'}]",Urology,['10.1016/j.urology.2020.09.030']
1997,33022318,Treating tobacco dependence to aid Re-employment among job-seekers: A randomized controlled trial.,"INTRODUCTION


U.S. reductions in smoking have not been experienced equally. Smoking prevalence is greater among persons of lower education, lower income, and unemployed. We evaluated whether a cessation intervention for job-seekers would result in significantly fewer cigarettes smoked per day and a greater likelihood of tobacco abstinence and re-employment, compared to the control condition at 6-months follow-up.
METHODS


Unemployed, job-seekers who smoked daily were recruited from five employment development departments in the San Francisco Bay Area, October 2015 to February 2018. Intention to quit smoking was not required. Participants were randomized to a brief motivationally-tailored, computer-assisted counseling intervention or referred to a toll-free quitline. Midstudy, 8-weeks of combination nicotine replacement was added to the intervention. Expired carbon monoxide and cotinine testing verified abstinence. Data were analyzed fall 2019.
RESULTS


Participants (N = 360; 70% men; 43% African American, 27% non-Hispanic Caucasian; 19% unhoused) averaged 12 cigarettes/day (SD = 6), 67% smoked within 30 min of wakening; 27% were in preparation stage to quit. During the 6-month study period, intervention participants were more likely to make a quit attempt (71% vs. 58%, p = .021) and reported significantly greater reduction in cigarettes/day than control participants (median reduction: 6.9 vs. 5.0, p = .038); however, bioconfirmed abstinence (3%) and re-employment (36%) did not differ by treatment group.
CONCLUSIONS


In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition. A priority group, further research is needed on smoking and re-employment.",2020,"In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition.","['Participants (N\u202f=\u202f360; 70% men; 43% African American, 27% non-Hispanic Caucasian', 'job-seekers', 'Unemployed, job-seekers who smoked daily were recruited from five employment development departments in the San Francisco Bay Area, October 2015 to February 2018']","['nicotine replacement', 'brief motivationally-tailored, computer-assisted counseling intervention or referred to a toll-free quitline']","['bioconfirmed abstinence', 'quit attempt', 'quit attempts and smoking reduction']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}]",,0.0440133,"In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition.","[{'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America. Electronic address: jpro@stanford.edu.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Brown-Johnson', 'Affiliation': 'Evaluation Sciences Unit, Division of Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baiocchi', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Adrienne S', 'Initials': 'AS', 'LastName': 'Lazaro', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chieng', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Stinson', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Anzai', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106259']
1998,33022324,Fit and Strong! Plus: Twelve and eighteen month follow-up results for a comparative effectiveness trial among overweight/obese older adults with osteoarthritis.,"This comparative effectiveness trial compared the longer-term effectiveness (12 and 18 months) of the standard Fit & Strong! physical activity program to Fit & Strong! Plus, which combined physical activity and dietary weight loss. Outcomes were weight, diet quality, physical activity, osteoarthritis symptoms, performance measures, and anxiety/depression. In this study, 413 overweight/obese participants with OA, ≥60 years old and primarily African American, were randomly assigned to Fit & Strong! (F&S!) or Fit & Strong! Plus (F&S! Plus), with outcomes assessed at 2, 6, 12, and 18 months. 356 (86%) participants completed the 18-month visit. Compared with participants randomized to standard F&S!, F&S! Plus participants maintained longer-term benefits at 12 months in weight (mean change ± SE: -1.7 ± 0.3 kg for F&S! Plus vs -0.9 ± 0.3 kg for F&S!, p = 0.049), BMI (-0.6 ± 0.1 vs -0.3 ± 0.1 kg/m 2 , p = 0.04), waist circumference (-2.7 ± 0.6 vs -0.4 ± 0.6 cm, p = 0.004), and lower extremity strength (1.6 ± 0.2 vs 1.0 ± 0.2 chair stands, p = 0.046). At 18 months, F&S! Plus participants showed improved lower extremity strength (1.4 ± 0.2 vs. 0.7 ± 0.2 chair stands, p = 0.045. African American older adults in the F&S! Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.",2020,"Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.","['356 (86%) participants completed the 18-month visit', 'African American older adults in the F&S', '413 overweight/obese participants with OA, ≥60\u202fyears old and primarily African American', 'overweight/obese older adults with osteoarthritis']","['Plus (F&S', 'Fit & Strong', 'physical activity program to Fit & Strong', 'standard Fit & Strong', 'standard F&S!, F&S', 'F&S']","['BMI', 'weight, waist circumference, and lower extremity strength', 'weight, diet quality, physical activity, osteoarthritis symptoms, performance measures, and anxiety/depression', 'waist circumference', 'lower extremity strength']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",413.0,0.0535567,"Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.","[{'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Fitzgibbon', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; University of Illinois Cancer Center, 818 South Wolcott Avenue, Chicago, IL 60612, United States of America; Department of Pediatrics, University of Illinois at Chicago, 840 South Wood Street, Chicago, IL 60612, United States of America. Electronic address: mlf@uic.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tussing-Humphreys', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; University of Illinois Cancer Center, 818 South Wolcott Avenue, Chicago, IL 60612, United States of America; Department of Medicine, University of Illinois at Chicago, 808 South Wood Street, Chicago, IL 60612, United States of America.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schiffer', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Renae', 'Initials': 'R', 'LastName': 'Smith-Ray', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Health Analytics, Research and Reporting, Walgreen Co., 102 Wilmot Road, Deerfield, IL 60015, United States of America.'}, {'ForeName': 'David X', 'Initials': 'DX', 'LastName': 'Marquez', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Department of Kinesiology and Nutrition, University of Illinois at Chicago, 1919 West Taylor Street, Chicago, IL 60612, United States of America.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'DeMott', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Berbaum', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Hughes', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Division of Community Health Sciences, University of Illinois at Chicago, 1603 West Taylor Street, IL 60612, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106267']
1999,33022345,Effects of tDCS on neuroplasticity and inflammatory biomarkers in bipolar depression: Results from a sham-controlled study.,"OBJECTIVES


We investigated the role of peripheral biomarkers associated with neuroplasticity and immune-inflammatory processes on the effects of transcranial direct current stimulation (tDCS), a safe, affordable, and portable non-invasive neuromodulatory treatment, in bipolar depression.
METHODS


This is an exploratory analysis using a dataset from the sham-controlled study the Bipolar Depression Electrical Treatment Trial (BETTER)(clinicaltrials.govNCT02152878). Participants were 52 adults with type I or II bipolar disorder in a moderate-to-severe depressive episode, randomized to 12 bifrontal active or sham tDCS sessions over a 6-week treatment course. Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2, and KLOTHO were investigated at baseline and endpoint. We performed analyses unadjusted for multiple testing to evaluate whether baseline biomarkers were predictive for depression improvement and changed during treatment using linear regression models.
RESULTS


A time x group interaction (Cohen's d: -1.16, 95% CI = -1.96 to -0.3, p = .005) was found for IL-8, with greater reductions after active tDCS. Higher baseline IL-6 plasma levels was associated with symptomatic improvement after tDCS (F (1,43)  = 5.43; p = .025). Other associations were not significant.
CONCLUSIONS


Our exploratory findings suggested that IL-6 is a potential predictor of tDCS response and IL-8 might decrease after tDCS; although confirmatory studies are warranted due to the multiplicity of comparisons.",2020,"Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2, and KLOTHO were investigated at baseline and endpoint.","['bipolar depression', 'Participants were 52 adults with type I or II bipolar disorder in a moderate-to-severe depressive episode']","['12 bifrontal active or sham tDCS sessions', 'transcranial direct current stimulation (tDCS', 'tDCS']","['Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2', 'neuroplasticity and inflammatory biomarkers', 'Higher baseline IL-6 plasma levels']","[{'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}]","[{'cui': 'C0445448', 'cui_str': 'Bifrontal'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0027754', 'cui_str': 'Nerve growth factor'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0450499', 'cui_str': 'ST2'}, {'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",52.0,0.250759,"Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2, and KLOTHO were investigated at baseline and endpoint.","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Goerigk', 'Affiliation': 'Department of Psychological Methodology and Assessment, Ludwig-Maximilians-University, Munich, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität, Nußbaumstraße 7, 80336 Munich, Germany; Hochschule Fresenius, University of Applied Sciences, Munich, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cretaz', 'Affiliation': 'ECT Service, Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; Bipolar Disorder Research Program, Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Sampaio-Junior', 'Affiliation': 'Private practice, São Paulo, Brazil.'}, {'ForeName': 'Érica Leandro Marciano', 'Initials': 'ÉLM', 'LastName': 'Vieira', 'Affiliation': 'Interdisciplinary Laboratory of Medical Investigation, Faculdade de Medicina, Universidade Federal de Minas Gerais, Minas Gerais, Brazil; Centre for Addiction and Mental Healthy (CAMH), Toronto, ON, Canada.'}, {'ForeName': 'Wagner', 'Initials': 'W', 'LastName': 'Gattaz', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Izio', 'Initials': 'I', 'LastName': 'Klein', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Beny', 'Initials': 'B', 'LastName': 'Lafer', 'Affiliation': 'Bipolar Disorder Research Program, Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Antônio Lúcio', 'Initials': 'AL', 'LastName': 'Teixeira', 'Affiliation': 'Interdisciplinary Laboratory of Medical Investigation, Faculdade de Medicina, Universidade Federal de Minas Gerais, Minas Gerais, Brazil; Neuropsychiatry Program, Department of Psychiatry and Behavioral Science, UT Health, Houston, United States of America.'}, {'ForeName': 'André F', 'Initials': 'AF', 'LastName': 'Carvalho', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Centre for Addiction and Mental Healthy (CAMH), Toronto, ON, Canada.'}, {'ForeName': 'Paulo A', 'Initials': 'PA', 'LastName': 'Lotufo', 'Affiliation': 'Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, Av. Prof Lineu Prestes 2565, 05508-000 São Paulo, Brazil.'}, {'ForeName': 'Isabela M', 'Initials': 'IM', 'LastName': 'Benseñor', 'Affiliation': 'Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, Av. Prof Lineu Prestes 2565, 05508-000 São Paulo, Brazil.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Bühner', 'Affiliation': 'Department of Psychological Methodology and Assessment, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität, Nußbaumstraße 7, 80336 Munich, Germany.'}, {'ForeName': 'André R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, Av. Prof Lineu Prestes 2565, 05508-000 São Paulo, Brazil. Electronic address: brunoni@usp.br.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110119']
2000,33034639,Effect of Patient Financial Incentives on Statin Adherence and Lipid Control: A Randomized Clinical Trial.,"Importance


Financial incentives can improve medication adherence and cardiovascular disease risk, but the optimal design to promote sustained adherence after incentives are discontinued is unknown.
Objective


To determine whether 6-month interventions involving different financial incentives to encourage statin adherence reduce low-density lipoprotein cholesterol (LDL-C) levels from baseline to 12 months.
Design, Setting, and Participants


This 4-group, randomized clinical trial was conducted from August 2013 to July 2018 among several large US insurer or employer populations and the University of Pennsylvania Health System. The study population included adults with elevated risk of cardiovascular disease, suboptimal LDL-C control, and evidence of imperfect adherence to statin medication. Data analysis was performed from July 2017 to June 2019.
Interventions


The interventions lasted 6 months during which all participants received daily medication reminders and an electronic pill bottle. Statin adherence was measured by opening the bottle. For participants randomized to the 3 intervention groups, adherence was rewarded with financial incentives. The sweepstakes group involved incentives for daily adherence. In the deadline sweepstakes group, incentives were reduced if participants were adherent only after a reminder. The sweepstakes plus deposit contract group split incentives between daily adherence and a monthly deposit reduced for each day of nonadherence.
Main Outcomes and Measures


The primary outcome was change in LDL-C level from baseline to 12 months.
Results


Among 805 participants randomized (199 in the simple daily sweepstakes group, 204 in the deadline sweepstakes group, 201 in the sweepstakes plus deposit contract group, and 201 in the control group), the mean (SD) age was 58.5 (10.3) years; 519 participants (64.5%) were women, 514 (63.9%) had diabetes, and 273 (33.9%) had cardiovascular disease. The mean (SD) baseline LDL-C level was 143.2 (42.5) mg/dL. Measured adherence at 6 months (defined as the proportion of 180 days with electronic pill bottle opening) in the control group (0.69; 95% CI, 0.66-0.72) was lower than that in the simple sweepstakes group (0.84; 95% CI, 0.81-0.87), the deadline sweepstakes group (0.86; 95% CI, 0.83-0.89), and the sweepstakes plus deposit contract group (0.87; 95% CI, 0.84-0.90) (P < .001 for each incentive group vs control). LDL-C levels were measured for 636 participants at 12 months. Mean LDL-C level reductions from baseline to 12 months were 33.6 mg/dL (95% CI, 28.4-38.8 mg/dL) in the control group, 32.4 mg/dL (95% CI, 27.3-37.6 mg/dL) in the sweepstakes group, 33.2 mg/dL (95% CI, 28.1-38.3 mg/dL) in the deadline sweepstakes group, and 36.5 mg/dL (95% CI, 31.3-41.7 mg/dL) in the sweepstakes plus deposit contract group (adjusted P > .99 for each incentive group vs control).
Conclusions and Relevance


Compared with the control group, different financial incentives improved measured statin adherence but not LDL-C levels. This result points to the importance of directly measuring health outcomes, rather than simply adherence, in trials aimed at improving health behaviors.
Trial Registration


ClinicalTrials.gov Identifier: NCT01798784.",2020,"Mean LDL-C level reductions from baseline to 12 months were 33.6 mg/dL (95% CI, 28.4-38.8 mg/dL) in the control group, 32.4 mg/","['August 2013 to July 2018 among several large US insurer or employer populations and the University of Pennsylvania Health System', '636 participants at 12 months', '805 participants randomized (199 in the simple daily sweepstakes group, 204 in the deadline sweepstakes group, 201 in the sweepstakes plus deposit contract group, and 201 in the control group), the mean (SD) age was 58.5 (10.3) years; 519 participants (64.5%) were women, 514 (63.9%) had diabetes, and 273 (33.9%) had cardiovascular disease', 'adults with elevated risk of cardiovascular disease, suboptimal LDL-C control, and evidence of imperfect adherence to statin medication']","['dL', 'daily medication reminders and an electronic pill bottle', 'Patient Financial Incentives']","['statin adherence', 'low-density lipoprotein cholesterol (LDL-C) levels', 'Statin Adherence and Lipid Control', 'Statin adherence', 'LDL-C levels', 'mean (SD) baseline LDL-C level', 'change in LDL-C level', 'Mean LDL-C level reductions']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",805.0,0.18507,"Mean LDL-C level reductions from baseline to 12 months were 33.6 mg/dL (95% CI, 28.4-38.8 mg/dL) in the control group, 32.4 mg/","[{'ForeName': 'Iwan', 'Initials': 'I', 'LastName': 'Barankay', 'Affiliation': 'Department of Management, The Wharton School, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Reese', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Putt', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Louise B', 'Initials': 'LB', 'LastName': 'Russell', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Loewenstein', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pagnotti', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jingsan', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'McGilloway', 'Affiliation': 'Department of Medicine and Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Troyen', 'Initials': 'T', 'LastName': 'Brennan', 'Affiliation': 'Department of Health Policy and Management, T. H. Chan School of Public Health, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Darra', 'Initials': 'D', 'LastName': 'Finnerty', 'Affiliation': 'Department of Medicine and Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hoffer', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Sakshum', 'Initials': 'S', 'LastName': 'Chadha', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, New Jersey.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.19429']
2001,33037036,Further improvement in glycemic control after switching from exenatide two times per day to exenatide once-weekly autoinjected suspension in patients with type 2 diabetes: 52-week results from the DURATION-NEO-1 study.,"INTRODUCTION


Investigate the effects of switching from two times per day exenatide to once-weekly exenatide administered by autoinjector (exenatide once-weekly suspension by autoinjector (QWS-AI)) or treatment with exenatide QWS-AI for 1 year.
RESEARCH DESIGN AND METHODS


In this phase III open-label study, adults with type 2 diabetes were randomized to receive exenatide QWS-AI (2 mg) or exenatide two times per day (5 mcg for 4 weeks, followed by 10 mcg) for 28 weeks. During a subsequent non-randomized 24-week extension, patients who received exenatide two times per day were switched to exenatide QWS-AI and those randomized to exenatide QWS-AI continued this treatment. Efficacy measures included changes from baseline in glycated hemoglobin (A1C), fasting plasma glucose (FPG), and body weight.
RESULTS


In total, 315 patients (mean baseline A1C of 8.5%) completed the initial 28 weeks of randomized treatment with exenatide QWS-AI (n=197) or exenatide two times per day (n=118) and were included in the 24-week extension (mean A1C of 7.0% and 7.3%, respectively, at week 28). From weeks 28-52, patients who switched from exenatide two times per day to exenatide QWS-AI had additional A1C reductions of approximately 0.5% (mean A1C change from baseline of -1.4% at week 52) and further reductions from baseline in FPG. Patients who continued exenatide QWS-AI treatment for 52 weeks showed clinically relevant A1C reductions (mean A1C change from baseline of -1.3% at week 52). Body-weight reductions achieved through week 28 were sustained at week 52 in both groups. There were no unexpected safety concerns or changes in the safety profile among patients who switched from exenatide two times per day to exenatide QWS-AI or those who continued exenatide QWS-AI treatment for 52 weeks.
CONCLUSIONS


Switching from exenatide two times per day to exenatide QWS-AI resulted in further A1C reductions and maintenance of earlier decreases in body weight, while continued therapy with exenatide QWS-AI for 52 weeks maintained A1C and body-weight reductions, without additional safety or tolerability concerns.
TRIAL REGISTRATION NUMBER


NCT01652716.",2020,"Efficacy measures included changes from baseline in glycated hemoglobin (A1C), fasting plasma glucose (FPG), and body weight.
","['adults with type 2 diabetes', 'patients with type 2 diabetes', '315 patients (mean baseline A1C of 8.5%) completed the initial 28 weeks of randomized treatment with']","['exenatide QWS-AI (n=197) or exenatide', 'exenatide', 'exenatide administered by autoinjector (exenatide once-weekly suspension by autoinjector (QWS-AI)) or treatment with exenatide QWS-AI', 'exenatide QWS-AI', 'exenatide QWS-AI (2\u2009mg) or exenatide']","['clinically relevant A1C reductions', 'glycated hemoglobin (A1C), fasting plasma glucose (FPG), and body weight', 'Body-weight reductions', 'glycemic control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",315.0,0.0159734,"Efficacy measures included changes from baseline in glycated hemoglobin (A1C), fasting plasma glucose (FPG), and body weight.
","[{'ForeName': 'Carol H', 'Initials': 'CH', 'LastName': 'Wysham', 'Affiliation': 'Section of Endocrinology and Metabolism, MultiCare Rockwood Clinic, Spokane, Washington, USA cwysham@multicare.org.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, Texas, USA.'}, {'ForeName': 'Marion L', 'Initials': 'ML', 'LastName': 'Vetter', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Hardy', 'Affiliation': 'Late clinical development, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'Clinical, Diabetes, Metabolism and GI, AstraZeneca, Gaithersburg, Maryland, USA.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000773']
2002,33015888,Effectiveness of adjuvant FOLFOX vs 5FU/LV in adults over age 65 with stage II and III colon cancer using a novel hybrid approach.,"PURPOSE


Estimates of cancer therapy effects can differ in clinical trials and clinical practice, partly due to underrepresentation of certain patient subgroups in trials. We utilize a hybrid approach, combining clinical trial and real-world data, to estimate the comparative effectiveness of two adjuvant chemotherapy regimens for colon cancer.
METHODS


We identified patients aged 66 and older enrolled in the Multicenter International Study of Oxaliplatin/5FU-LV in the Adjuvant Treatment of Colon Cancer. Similar patients were identified in the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, initiating adjuvant chemotherapy with either 5-fluorouracil (5FU) alone or in combination with oxaliplatin (FOLFOX). We used logistic regression to estimate the likelihood of trial enrollment as a function of age, sex, and substage. Using inverse odds of sampling weights (IOSW), we compared 5-year mortality in patients randomized to FOLFOX vs 5FU using weighted Cox proportional hazards regression, the Nelson-Aalen estimator for cumulative hazards, and bootstrapping for 95% confidence intervals (CIs).
RESULTS


There were 690 trial participants and 3834 SEER-Medicare patients. The SEER-Medicare population was older and had a higher proportion of stage IIIB and IIIC patients than the trial. After controlling for differences between populations, the IOSW 5-year HR was 1.21 (0.89, 1.65), slightly farther from the null than the trial estimate (HR = 1.14, 95%CI: 0.87, 1.49).
CONCLUSIONS


This study supports mounting evidence of little to no incremental reduction in 5-year mortality for FOLFOX vs 5FU in older adults with stage II-III colon cancer, emphasizing the importance of combining clinical trial and real-world data to support such conclusions.",2020,"This study supports mounting evidence of little to no incremental reduction in five-year mortality for FOLFOX versus 5FU in older adults with stage II-III colon cancer, emphasizing the importance of combining clinical trial and real-world data to support such conclusions.","['690 trial participants and 3,834 SEER-Medicare patients', 'older adults with stage II-III colon cancer', 'patients age 66 and older enrolled in the Multicenter International Study of', 'adults over age 65 with stage II and III colon cancer', 'colon cancer']","['FOLFOX versus 5FU', 'adjuvant FOLFOX versus 5FU/LV', 'Oxaliplatin/5FU-LV', '5-fluorouracil (5FU) alone or in combination with oxaliplatin (FOLFOX', 'FOLFOX']","['sampling weights (IOSW', 'IOSW 5-year HR']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0807984', 'cui_str': 'Specimen weight'}, {'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.118313,"This study supports mounting evidence of little to no incremental reduction in five-year mortality for FOLFOX versus 5FU in older adults with stage II-III colon cancer, emphasizing the importance of combining clinical trial and real-world data to support such conclusions.","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Lund', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Webster-Clark', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Sharon Peacock', 'Initials': 'SP', 'LastName': 'Hinton', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Shahar', 'Initials': 'S', 'LastName': 'Shmuel', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Til', 'Initials': 'T', 'LastName': 'Stürmer', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Hanna K', 'Initials': 'HK', 'LastName': 'Sanoff', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",Pharmacoepidemiology and drug safety,['10.1002/pds.5148']
2003,33010934,"[Effect of palonosetron, ondansetron and dexamethasone in the prevention of postoperative nausea and vomiting in video cholecystectomy with total venous anesthesia with propofol-remifentanil - randomized clinical trial].","INTRODUCTION AND OBJECTIVES


The incidence of Postoperative Nausea and Vomiting (PONV) after video cholecystectomy is high. Progress in pharmacological PONV prophylaxis includes a new generation of 5-HT 3  antagonists. This study aims to assess the effect of the 5-HT 3  antagonist in postanesthetic antiemetic management of patients submitted to laparoscopic cholecystectomy with total intravenous anesthesia.
METHODS


Sixty individuals who underwent video cholecystectomy were randomized into three groups of 20 individuals according to the treatment administered: 0.125 mg of palonosetron (Group 1); 4 mg of ondansetron associated with 4 mg of dexamethasone (Group 2); 4 mg of dexamethasone (Group 3). General intravenous anesthesia was performed with propofol, remifentanil and rocuronium. The group to which the participant belonged was concealed from the investigator who assessed drug effect. PONV was assessed using the Rhodes Scale at 12 and 24 hours after surgery. Rescue medication was 0.655 to 1.5 mg of droperidol.
RESULTS


Group 1 presented a lower incidence of PONV and required less rescue medication in the first postoperative hour. There was no significant difference among the three groups regarding PONV incidence in the first 12 postoperative hours. Groups 1 and 2 were superior to Group 3 regarding the control of PONV from 12 to 24 hours, and after rescue medication from 12 to 24 hours. Group 1 showed significantly superior nausea control in the first 12 postoperative hours.
CONCLUSIONS


The present study showed evidence that palonosetron is superior to the drugs compared regarding a protracted antiemetic effect and less requirement of rescue drugs, mainly related to its ability to completely inhibit the uncomfortable symptom of nausea.",2020,"Groups 1 and 2 were superior to Group 3 regarding the control of PONV from 12 to 24 hours, and after rescue medication from 12 to 24 hours.","['patients submitted to laparoscopic cholecystectomy with total intravenous anesthesia', 'video cholecystectomy with total venous anesthesia with', 'Sixty individuals who underwent']","['droperidol', 'ondansetron associated with 4\xa0mg of dexamethasone', 'propofol-remifentanil', 'video cholecystectomy', 'palonosetron', 'dexamethasone', 'propofol, remifentanil and rocuronium', '5-HT 3  antagonist', 'palonosetron, ondansetron and dexamethasone']","['PONV incidence', 'postoperative nausea and vomiting', 'PONV', 'Postoperative Nausea and Vomiting (PONV', 'superior nausea control', 'incidence of PONV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0013136', 'cui_str': 'Droperidol'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C1700654', 'cui_str': 'HTR3A protein, human'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",60.0,0.0368543,"Groups 1 and 2 were superior to Group 3 regarding the control of PONV from 12 to 24 hours, and after rescue medication from 12 to 24 hours.","[{'ForeName': 'Neuber Martins', 'Initials': 'NM', 'LastName': 'Fonseca', 'Affiliation': 'Universidade Federal de Uberlândia (UFU), Faculdade de Medicina, Disciplina de Anestesiologia, Uberlândia, MG, Brasil; Sociedade Brasileira de Anestesiologia (SBA), Comissão de Normas Técnicas, Brasil; CET-FMUF, Uberlândia, MG, Brasil; Coordinator of CE\xa026.06001 - Equipamento Respiratório e de Anestesia da ABNT and Delegate of ABNT no ISO/TC 121 - Anaesthetic and Respiratory Equipment, Uberlândia, MG, Brasil. Electronic address: neubermf@gmail.com.'}, {'ForeName': 'Ludmila Ribeiro', 'Initials': 'LR', 'LastName': 'Pedrosa', 'Affiliation': 'Universidade Federal de Uberlândia (UFU), Uberlândia, MG, Brasil.'}, {'ForeName': 'Natália', 'Initials': 'N', 'LastName': 'Melo', 'Affiliation': 'Universidade Federal de Uberlândia (UFU), Curso de Medicina, Uberlândia, MG, Brasil.'}, {'ForeName': 'Ricardo de Ávila', 'Initials': 'RÁ', 'LastName': 'Oliveira', 'Affiliation': 'Universidade Federal de Uberlândia (UFU), Curso de Medicina, Departamento de Cirurgia, Disciplina de Cirurgia Vascular, Uberlândia, MG, Brasil.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.08.001']
2004,33011715,Training gamblers to re-think their gambling choices: How contextual analytical thinking may be useful in promoting safer gambling.,"Background and aims


Harmful gambling has been associated with the endorsement of fallacious cognitions that promote excessive consumption. These types of beliefs stem from intuitively derived assumptions about gambling that are fostered by fast-thinking and a lack of objective, critical thought. The current paper details an experiment designed to test whether a four-week online intervention to strengthen contextual analytical thinking in gamblers is effective in changing gamblers cognitions and encouraging safer gambling consumption.
Methods


Ninety-four regular gamblers who reported experiencing gambling-related harm were randomly allocated to either an experimental (n = 46) or control condition (n = 48), including 45 males, ranging from 19 to 65 years of age (M = 36.61; SD = 9.76). Following baseline measurement of gambling beliefs and prior week gambling consumption, participants in the experimental condition were required to complete an adaption of the Gamblers Fallacy Questionnaire designed to promote analytical thinking by educating participants on common judgement errors specific to gambling once a week for four weeks. Post-intervention measures of beliefs and gambling consumption were captured in week five.
Results


The experimental condition reported significantly fewer erroneous cognitions, greater endorsement of protective cognitions, and reduced time spent gambling post-intervention compared to baseline. The control group also reported a reduction in cognitions relating to predicting and controlling gambling outcomes.
Conclusion


Cognitive interventions that encourage gamblers to challenge gambling beliefs by reflecting on gambling involvement and promoting critical thinking may be an effective tool for reducing the time people invest in gambling activities.",2020,"The experimental condition reported significantly fewer erroneous cognitions, greater endorsement of protective cognitions, and reduced time spent gambling post-intervention compared to baseline.","['n = 48), including 45 males, ranging from 19 to 65 years of age (M = 36.61; SD = 9.76', 'Methods\n\n\nNinety-four regular gamblers who reported experiencing gambling-related harm']","['control condition', 'Cognitive interventions']","['erroneous cognitions, greater endorsement of protective cognitions', 'reduction in cognitions relating to predicting and controlling gambling outcomes', 'beliefs and gambling consumption']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3541364', 'cui_str': 'Erroneous'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",94.0,0.0622413,"The experimental condition reported significantly fewer erroneous cognitions, greater endorsement of protective cognitions, and reduced time spent gambling post-intervention compared to baseline.","[{'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Armstrong', 'Affiliation': '1School of Human, Medical, and Applied Sciences, CQUniversity, 44 Greenhill Road, Wayville, SA, 5034, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Rockloff', 'Affiliation': '2School of Human, Medical, and Applied Sciences, CQUniversity, University Drive, Bundaberg, QLD, 4670, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Browne', 'Affiliation': '2School of Human, Medical, and Applied Sciences, CQUniversity, University Drive, Bundaberg, QLD, 4670, Australia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Blaszczynski', 'Affiliation': '3Brain and Mind Centre, School of Psychology, The University of Sydney, M02F Mallett Street Campus, Sydney, NSW, 2006, Australia.'}]",Journal of behavioral addictions,['10.1556/2006.2020.00049']
2005,33012216,Whey protein supplementation does not accelerate recovery from a single bout of eccentric exercise.,"The current double blind, randomized, placebo-controlled trial with two parallel groups aimed to assess the impact of whey protein supplementation on recovery of muscle function and muscle soreness following eccentric exercise. During a 9-day period, forty recreationally active males received twice daily supplementation with either whey protein (PRO; 60 g/day) or an iso-energetic amount of carbohydrate (CON). Muscle function and soreness were assessed before, and 0, 3, 24, 48, and 72 h after performing 100 drop jumps. Recovery of isometric maximal voluntary contraction (MVC) did not significantly differ between groups (timextreatment,  P  = 0.56). In contrast, the recovery of isokinetic MVC at 90°·s -1  was faster in CON as opposed to PRO (timextreatment interaction,  P  = 0.044). Recovery of isokinetic MVC at 180°·s -1  was also faster in CON as opposed to PRO (timextreatment interaction,  P  = 0.011). Recovery of countermovement jump performance did not differ between groups (timextreatment interaction,  P  = 0.52). Muscle soreness, CK and CRP showed a transient increase over time ( P  < 0.001), with no differences between groups. In conclusion, whey protein supplementation does not accelerate recovery of muscle function or attenuate muscle soreness and inflammation during 3 days of recovery from a single bout of eccentric exercise.",2020,"Muscle soreness, CK and CRP showed a transient increase over time ( P  < 0.001), with no differences between groups.",['forty recreationally active males received'],"['twice daily supplementation with either whey protein (PRO; 60\xa0g/day) or an iso-energetic amount of carbohydrate (CON', 'Whey protein supplementation', 'placebo', 'whey protein supplementation']","['recovery of isokinetic MVC', 'Muscle soreness, CK and CRP', 'Recovery of isometric maximal voluntary contraction (MVC', 'Recovery of isokinetic MVC', 'Recovery of countermovement jump performance', 'Muscle function and soreness', 'recovery of muscle function and muscle soreness']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}]",,0.472525,"Muscle soreness, CK and CRP showed a transient increase over time ( P  < 0.001), with no differences between groups.","[{'ForeName': 'Luuk', 'Initials': 'L', 'LastName': 'Hilkens', 'Affiliation': 'Institute of Sports and Exercise Studies, HAN University of Applied Sciences , Nijmegen, The Netherlands.'}, {'ForeName': 'Jolien', 'Initials': 'J', 'LastName': 'De Bock', 'Affiliation': 'Institute of Sports and Exercise Studies, HAN University of Applied Sciences , Nijmegen, The Netherlands.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Kretzers', 'Affiliation': 'Institute of Sports and Exercise Studies, HAN University of Applied Sciences , Nijmegen, The Netherlands.'}, {'ForeName': 'Alwine F M', 'Initials': 'AFM', 'LastName': 'Kardinaal', 'Affiliation': 'NIZO Food Research , Ede, The Netherlands.'}, {'ForeName': 'Esther G', 'Initials': 'EG', 'LastName': 'Floris-Vollenbroek', 'Affiliation': 'NIZO Food Research , Ede, The Netherlands.'}, {'ForeName': 'Petra A M J', 'Initials': 'PAMJ', 'LastName': 'Scholtens', 'Affiliation': 'NIZO Food Research , Ede, The Netherlands.'}, {'ForeName': 'Astrid M H', 'Initials': 'AMH', 'LastName': 'Horstman', 'Affiliation': 'FrieslandCampina , Amersfoort, The Netherlands.'}, {'ForeName': 'Luc J C', 'Initials': 'LJC', 'LastName': 'van Loon', 'Affiliation': 'Institute of Sports and Exercise Studies, HAN University of Applied Sciences , Nijmegen, The Netherlands.'}, {'ForeName': 'Jan-Willem', 'Initials': 'JW', 'LastName': 'van Dijk', 'Affiliation': 'Institute of Sports and Exercise Studies, HAN University of Applied Sciences , Nijmegen, The Netherlands.'}]",Journal of sports sciences,['10.1080/02640414.2020.1820184']
2006,33012605,First-in-human randomised trial and follow-up study of Plasmodium falciparum blood-stage malaria vaccine BK-SE36 with CpG-ODN(K3).,"BACKGROUND


BK-SE36 is blood-stage malaria vaccine candidate that is undergoing clinical trials. Here, the safety and immunogenicity of BK-SE36 with a novel adjuvant, CpG-ODN(K3) (thus, BK-SE36/CpG) was assessed in a phase 1a trial in Japan.
METHODS


An investigator-initiated, randomised, single-blind, placebo-controlled, dose-escalation study was conducted at Osaka University Hospital with 26 healthy malaria naïve Japanese male adults. The trial was conducted in two stages: Stage/Group 1, half-dose (n = 7 for BK-SE36/CpG and n = 3 for control) and Stage/Group 2, full-dose (n = 11 for BK-SE36/CpG and n = 5 for control). There were two intramuscular vaccinations 21 days apart for both half-dose (0.5 ml: 50 µg SE36 + 500 µg aluminum + 500 µg K3) and full-dose (1.0 ml: 100 µg SE36 + 1000 µg aluminum + 1000 µg K3). A one-year follow-up was done to monitor changes in autoimmune markers and vaccine-induced antibody response.
RESULTS


BK-SE36/CpG was well tolerated. Vaccination site reactions were similar to those observed with BK-SE36. During the trial and follow-up period, no subject had clinical evidence of autoimmune disease. The full-dose group had significantly higher titres than the half-dose group (Student's t-test, p = 0.002) at 21 days post-second vaccination. Antibody titres remained above baseline values during 12 months of follow-up. The vaccine induced antibody was mostly composed of IgG1 and IgM, and recognised epitopes close to the polyserine region located in the middle of SE36.
CONCLUSIONS


BK-SE36/CpG has an acceptable safety profile. Use of CpG-ODN(K3) greatly enhanced immunogenicity in malaria naïve Japanese adults when compared to BK-SE36 alone. The utility of BK-SE36/CpG is currently under evaluation in a malaria endemic setting in West Africa.
TRIAL REGISTRATION


JMACCT Clinical Trial Registry JMA-IIA00109.",2020,"The full-dose group had significantly higher titres than the half-dose group (Student's t-test, p = 0.002) at 21 days post-second vaccination.","['26 healthy malaria naïve Japanese male adults', 'malaria naïve Japanese adults', 'malaria endemic setting in West Africa']","['BK-SE36/CpG', 'CpG-ODN(K3', 'SE36\xa0+\xa0500\xa0µg aluminum\xa0+\xa0500\xa0µg\xa0K3) and full-dose', 'Plasmodium falciparum blood-stage malaria vaccine BK-SE36 with CpG-ODN(K3', 'placebo', 'SE36\xa0+\xa01000\xa0µg aluminum\xa0+\xa01000\xa0µg\xa0K3']","['immunogenicity', 'Antibody titres', 'tolerated', 'Vaccination site reactions']","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0001747', 'cui_str': 'Western Africa'}]","[{'cui': 'C0056912', 'cui_str': ""cytidylyl-3'-5'-guanosine""}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032150', 'cui_str': 'Plasmodium falciparum'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0206255', 'cui_str': 'Malarial Vaccines'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C1142480', 'cui_str': 'Vaccination site reaction'}]",,0.109799,"The full-dose group had significantly higher titres than the half-dose group (Student's t-test, p = 0.002) at 21 days post-second vaccination.","[{'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Ezoe', 'Affiliation': 'Medical Center for Translational Research, Department of Medical Innovation, Osaka University Hospital, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan; Department of Environmental Space Infection Control, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Nirianne Marie Q', 'Initials': 'NMQ', 'LastName': 'Palacpac', 'Affiliation': 'Department of Molecular Protozoology, Research Institute for Microbial Diseases, Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Kohhei', 'Initials': 'K', 'LastName': 'Tetsutani', 'Affiliation': 'Laboratory of Adjuvant Innovation/Mockup Vaccine, Center for Vaccine Adjuvant Research, National Institute of Biomedical Innovation, Health and Nutrition, 7-6-8, Saito-Asagi, Ibaraki City, Osaka 567-0085, Japan; Laboratory of Vaccine Science, Immunology Frontier Research Center (IFReC), Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Kouji', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Data Coordinating Center, Department of Medical Innovation, Osaka University Hospital, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'Department of Orthopaedics, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Taira', 'Affiliation': 'Medical Center for Translational Research, Department of Medical Innovation, Osaka University Hospital, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan; Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Sumiyuki', 'Initials': 'S', 'LastName': 'Nishida', 'Affiliation': 'Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Hirata', 'Affiliation': 'Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ogata', 'Affiliation': 'Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Data Coordinating Center, Department of Medical Innovation, Osaka University Hospital, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Yagi', 'Affiliation': 'Department of Molecular Protozoology, Research Institute for Microbial Diseases, Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Jyotheeswara R', 'Initials': 'JR', 'LastName': 'Edula', 'Affiliation': 'Department of Molecular Protozoology, Research Institute for Microbial Diseases, Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Oishi', 'Affiliation': 'Department of Molecular Protozoology, Research Institute for Microbial Diseases, Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tougan', 'Affiliation': 'Department of Molecular Protozoology, Research Institute for Microbial Diseases, Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Ken J', 'Initials': 'KJ', 'LastName': 'Ishii', 'Affiliation': 'Laboratory of Adjuvant Innovation/Mockup Vaccine, Center for Vaccine Adjuvant Research, National Institute of Biomedical Innovation, Health and Nutrition, 7-6-8, Saito-Asagi, Ibaraki City, Osaka 567-0085, Japan; Laboratory of Vaccine Science, Immunology Frontier Research Center (IFReC), Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Myoui', 'Affiliation': 'Medical Center for Translational Research, Department of Medical Innovation, Osaka University Hospital, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan. Electronic address: myoi@hp-mctr.med.osaka-u.ac.jp.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Horii', 'Affiliation': 'Department of Molecular Protozoology, Research Institute for Microbial Diseases, Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan. Electronic address: horii@biken.osaka-u.ac.jp.'}]",Vaccine,['10.1016/j.vaccine.2020.09.056']
2007,33017755,Admission Blood Pressure and Outcome of Endovascular Therapy: Secondary Analysis of ASTER Trial.,"BACKGROUND


Elevated blood pressure (BP) is common among patients presenting with acute ischemic stroke due to large vessel occlusions. The literature is inconsistent regarding the association between admission BP and outcome of mechanical thrombectomy (MT). Moreover, it is unclear whether the first line thrombectomy strategy (stent retriever [SR] versus contact aspiration [CA]) modifies the relationship between BP and outcome.
METHODS


This is a post hoc analysis of the ASTER (Contact Aspiration Versus Stent Retriever for Successful Revascularization) randomized trial. BP was measured prior to randomization in all included patients. Co-primary outcomes included 90-day functional independence (modified Rankin Scale [mRS] 0-2) and successful revascularization (modified Treatment in Cerebral Ischemia [mTICI] 2b-3). Secondary outcomes included symptomatic intracerebral hemorrhage (sICH) and parenchymal hemorrhage (PH) within 24 hours.
RESULTS


A total of 381 patients were included in the present study. Mean (SD) systolic BP (SBP) and diastolic BP (DBP) were 148 (26) mm Hg and 81 (16) mm Hg, respectively. There was no association between SBP or DBP and successful revascularization or 90-day functional independence. Similarly, there was no association between admission SBP or DBP with sICH or PH. Subgroup analysis based on the first-line thrombectomy strategy revealed similar results with no heterogeneity across groups.
CONCLUSION


Admission BP was not associated with functional, angiographic or safety outcomes. Results were similar in both CA and CA groups.",2020,There was no association between SBP or DBP and successful revascularization or 90-day functional independence.,"['patients presenting with acute ischemic stroke due to large vessel occlusions', 'A total of 381 patients were included in the present study']",['contact aspiration [CA'],"['Mean (SD) systolic BP (SBP) and diastolic BP (DBP', 'symptomatic intracerebral hemorrhage (sICH) and parenchymal hemorrhage (PH', 'SBP or DBP and successful revascularization or 90-day functional independence', '90-day functional independence (modified Rankin Scale [mRS] 0-2) and successful revascularization (modified Treatment in Cerebral Ischemia', 'Admission BP', 'BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708787', 'cui_str': '381'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",381.0,0.0769627,There was no association between SBP or DBP and successful revascularization or 90-day functional independence.,"[{'ForeName': 'Mohnammd', 'Initials': 'M', 'LastName': 'Anadani', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St Louis, MO, United States. Electronic address: manadani@wustl.edu.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lapergue', 'Affiliation': 'Department of Stroke Center, Foch Hospital, Suresnes, France. Electronic address: bertrand.lapergue@gmail.com.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Blanc', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation, Paris, France. Electronic address: rblanc29@gmail.com.'}, {'ForeName': 'Maéva', 'Initials': 'M', 'LastName': 'Kyheng', 'Affiliation': 'Department of Biostatistics, University Lille, CHU Lille, EA 2694-Santé Publique: Epidémiologie et Qualité des Soins, France. Electronic address: maeva.kyheng@chru-lille.fr.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'Department of Biostatistics, University Lille, CHU Lille, EA 2694-Santé Publique: Epidémiologie et Qualité des Soins, France. Electronic address: julien.labreuche.chru@gmail.com.'}, {'ForeName': 'Malek Ben', 'Initials': 'MB', 'LastName': 'Machaa', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation, Paris, France. Electronic address: mbenmaacha@for.paris.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Duhamel', 'Affiliation': 'Department of Biostatistics, University Lille, CHU Lille, EA 2694-Santé Publique: Epidémiologie et Qualité des Soins, France. Electronic address: alain.duhamel59@gmail.com.'}, {'ForeName': 'Gautier', 'Initials': 'G', 'LastName': 'Marnat', 'Affiliation': 'Department of Neuroradiology, University Hospital of Bordeaux, France. Electronic address: gaultier.marnat@chu-bordeaux.fr.'}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Saleme', 'Affiliation': 'Department of Interventional Neuroradiology, University Hospital of Limoges, France. Electronic address: suzanna.saleme@chu-limoges.fr.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Costalat', 'Affiliation': 'Department of Neuroradiology, Hôpital Gui de Chauliac, Montpellier, France. Electronic address: vincentcost@hotmail.com.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Bracard', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Nancy, Université de Lorraine, INSERM U1254, Nancy, France. Electronic address: s.bracard@chru-nancy.fr.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Anxionnat', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Nancy, Université de Lorraine, INSERM U1254, Nancy, France. Electronic address: r.anxionnat@gmail.com.'}, {'ForeName': 'Alejandro M', 'Initials': 'AM', 'LastName': 'Spiotta', 'Affiliation': 'Department of Neurosurgery, Medical University of South Carolina, Charleston, SC, United States. Electronic address: spiotta@musc.edu.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'DeHavenon', 'Affiliation': 'Department of Neurology, Utah University, Salt lake, UT, United States. Electronic address: adam.dehavenon@hsc.utah.edu.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Richard', 'Affiliation': 'Department of Neurology, Stroke Unit, University Hospital of Nancy, Université de Lorraine, INSERM U1116, Nancy, France. Electronic address: s.richard@chru-nancy.fr.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Desal', 'Affiliation': 'Department of Neuroradiology, Guillaume et René Laennec University Hospital, Nantes, France. Electronic address: hubert.desal@chu-nantes.fr.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Mazighi', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation, Paris, France. Electronic address: mmazighi@for.paris.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Consoli', 'Affiliation': 'Department of Neuroradiology, Foch Hospital, Suresnes, France. Electronic address: a.consoli@hopital-foch.com.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Piotin', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation, Paris, France. Electronic address: mpiotin@for.paris.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Gory', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Nancy, Université de Lorraine, INSERM U1254, Nancy, France. Electronic address: benjagory@gmail.com.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105347']
2008,33017784,Nitrous oxide analgesia for external cephalic version: A randomized controlled trial.,"STUDY OBJECTIVE


Our study sought to determine whether or not nitrous oxide analgesia decreases pain compared to oxygen placebo during external cephalic version for breech presentation. Procedural success may be limited by pain and anxiety. Although neuraxial anesthesia has been studied extensively for these procedures, many centers lack resources for routine use. Nitrous oxide is noninvasive, has minimal side effects and requires limited facilities. We hypothesized that its analgesic properties would decrease pain compared to oxygen placebo during external cephalic version.
DESIGN


Double-blinded randomized placebo-controlled trial.
SETTING


Labor and delivery triage room.
PATIENTS


Forty-eight patients, ≥18 years of age, 37-weeks' gestation or beyond, singleton pregnancy, breech presentation, and American Society of Anesthesiology physical status I-III, having an external cephalic version.
INTERVENTIONS


Patients undergoing external cephalic version were randomized to receive self-administered 50% nitrous oxide/50% oxygen versus 100% oxygen placebo.
MEASUREMENTS


The primary outcome measured was intra-procedural pain. Secondary outcomes were intra-procedural anxiety, patient satisfaction, and procedure difficulty.
MAIN RESULTS


Forty-eight patients were enrolled; 23 received nitrous oxide and 25 received oxygen. No difference was noted in mean pain scores (nitrous oxide 5.5 ± 2.3, placebo 5.4 ± 2.7, [CI 95%  = -1.40, 1.51]; P = 0.943) or anxiety scores (nitrous oxide 1.6 ± 2.0, placebo 1.2 ± 1.8, [CI 95%  = -0.74, 1.45]; P = 0.515). Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95%  = -1.54, 1.66]; P = 0.944). There was a significant increase in the number of version attempts in the nitrous oxide group (nitrous oxide 3.9 ± 1.9, placebo 2.8 ± 1.4, [CI 95%  = 0.05, 2]; P = 0.046). Patient satisfaction was significantly lower in the nitrous oxide group (nitrous oxide 4.3 ± 4.0, placebo 6.9 ± 3.6, [CI 95%  = -4.93, -0.34]; P = 0.025).
CONCLUSION


Despite the desirable properties of nitrous oxide, there was no analgesic benefit over oxygen for external cephalic version. Its routine use for these procedures was not supported.",2020,"Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95%  = -1.54, 1.66];","['external cephalic version', 'Forty-eight patients were enrolled; 23 received', 'Patients undergoing external cephalic version', ""Forty-eight patients, ≥18\xa0years of age, 37-weeks' gestation or beyond, singleton pregnancy, breech presentation, and American Society of Anesthesiology physical status I-III, having an external cephalic version"", 'Labor and delivery triage room']","['placebo', 'Nitrous oxide', 'nitrous oxide and 25 received oxygen', 'oxygen placebo', 'Nitrous oxide analgesia', 'self-administered 50% nitrous oxide/50% oxygen versus 100% oxygen placebo', 'nitrous oxide analgesia', 'nitrous oxide']","['mean pain scores', 'Patient satisfaction', 'anxiety scores', 'Procedural difficulty', 'intra-procedural anxiety, patient satisfaction, and procedure difficulty', 'number of version attempts', 'intra-procedural pain', 'pain']","[{'cui': 'C0410877', 'cui_str': 'External cephalic version'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006157', 'cui_str': 'Breech presentation'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0040861', 'cui_str': 'Triage'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C3854439', 'cui_str': 'Procedural anxiety'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",48.0,0.62946,"Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95%  = -1.54, 1.66];","[{'ForeName': 'Lacey E', 'Initials': 'LE', 'LastName': 'Straube', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Lacey_straube@med.unc.edu.'}, {'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Fardelmann', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Kristen.fardelmann@yale.edu.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Penwarden', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: APenwarden@napaanesthesia.com.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: fei_chen@med.unc.edu.'}, {'ForeName': 'Elsje', 'Initials': 'E', 'LastName': 'Harker', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: elsje.harker@duke.unc.edu.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Redmon', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Benjamin.redmon@duke.edu.'}, {'ForeName': 'Quefeng', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'University of North Carolina School of Public Health, Department of Biostatistics, 135 Dauer Drive, Chapel Hill, NC 27599, USA. Electronic address: quefeng@email.unc.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Strauss', 'Affiliation': 'University of North Carolina School of Medicine, Department of Obstetrics & Gynecology, 3009 Old Clinic Building, CB 7050, Chapel Hill, NC 27599, USA. Electronic address: Robert_strauss@med.unc.edu.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Smith', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Kathleen_a_smith@med.unc.edu.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110073']
2009,33019861,Goal-Oriented Attention Self-Regulation Training Improves Executive Functioning in Veterans with PTSD and Mild TBI.,"Difficulties in executive-control functions are common sequelae of both Traumatic Brain Injury (TBI) and Post Traumatic Stress Disorder (PTSD). The goal of this study was to assess whether a cognitive rehabilitation training that was successfully applied in civilian and military TBI would be effective for military Veterans with comorbid PTSD and mild TBI (mTBI). In the prior study, Veterans with history of mild to severe TBI significantly improved after Goal-Oriented Attentional Self-Regulation (GOALS) training on measures of attention/executive function, functional task performance, and emotional regulation. The objective of this study was to assess effects of GOALS training in Veterans with comorbid PTSD and mTBI. Forty Veterans with current PTSD diagnosis and history of mTBI (6+ months post) were randomized to either five weeks of GOALS or Brain-Health Education (BHE) training matched in time and intensity. Evaluator-blinded assessments at baseline and post-training included neuropsychological and complex functional task performance, and self-report measures of emotional functioning/regulation. After GOALS, but not BHE training, participants significantly improved from baseline on primary outcome measures of: Overall Complex Attention/Executive Function neuropsychological performance composite [F = 12.35, p =.001; Cohen's d = .48], and Overall Mood Disturbance -POMS emotional regulation self-report [F=4.29, p=.05, Cohen's d = .41]. Additionally, GOALS, but not BHE participants indicated significant decrease in PTSD symptoms (PCL-M Total Score) [F=4.80, p=.05, Cohen's d =.60], and demonstrated improvement on complex functional task performance -GPS Learning and Memory [F=5.06, p=.05, Cohen's d =.56]. Training in attentional self-regulation applied to participant defined goals may improve cognitive functioning in Veterans with comorbid PTSD and mTBI. Improving cognitive control functioning may also improve functioning in other domains such as emotional regulation and functional performance, potentially making it particularly relevant for Veterans with history of mTBI and co-morbid psychiatric symptoms.",2020,"After GOALS, but not BHE training, participants significantly improved from baseline on primary outcome measures of: Overall Complex Attention/Executive Function neuropsychological performance composite [F = 12.35, p =.001; Cohen's d = .48], and Overall Mood Disturbance -POMS emotional regulation self-report [F=4.29, p=.05, Cohen's d = .41].","['military Veterans with comorbid PTSD and mild TBI (mTBI', 'Forty Veterans with current PTSD diagnosis and history of mTBI (6+ months post', 'Veterans with PTSD and Mild TBI', 'Veterans with comorbid PTSD and mTBI', 'Veterans with history of mTBI and co-morbid psychiatric symptoms']","['GOALS training', 'Goal-Oriented Attention Self-Regulation Training', 'cognitive rehabilitation training', 'Attentional Self-Regulation (GOALS) training', 'GOALS or Brain-Health Education (BHE) training']","['Overall Complex Attention/Executive Function neuropsychological performance composite', 'complex functional task performance -GPS Learning and Memory', 'cognitive functioning', 'attention/executive function, functional task performance, and emotional regulation', 'Overall Mood Disturbance -POMS emotional regulation self-report', 'neuropsychological and complex functional task performance, and self-report measures of emotional functioning/regulation', 'PTSD symptoms (PCL-M Total Score', 'Executive Functioning']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1704423', 'cui_str': 'Hereditary lymphedema'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0438524,"After GOALS, but not BHE training, participants significantly improved from baseline on primary outcome measures of: Overall Complex Attention/Executive Function neuropsychological performance composite [F = 12.35, p =.001; Cohen's d = .48], and Overall Mood Disturbance -POMS emotional regulation self-report [F=4.29, p=.05, Cohen's d = .41].","[{'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Novakovic-Agopian', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States.'}, {'ForeName': 'Lainie', 'Initials': 'L', 'LastName': 'Posecion', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States; lposecion@paloaltou.edu.'}, {'ForeName': 'Erica S', 'Initials': 'ES', 'LastName': 'Kornblith', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States; erica.kornblith@va.gov.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Abrams', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'McQuaid', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Neylan', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Burciaga', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States; joaquinburciaga@gmail.com.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Joseph', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Carlin', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States; Gerald.carlin@va.gov.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Groberio', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States; Jessica.Chang1@va.gov.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Maruyama', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States; brian.maruyama@va.gov.'}, {'ForeName': 'Anthony J-W', 'Initials': 'AJ', 'LastName': 'Chen', 'Affiliation': 'VA Northern California Health Care System, Martinez, California, United States.'}]",Journal of neurotrauma,['10.1089/neu.2019.6806']
2010,33026700,EMA Review of Daratumumab (Darzalex) for the Treatment of Adult Patients Newly Diagnosed with Multiple Myeloma.,"The use of daratumumab in combination with established regimens for the treatment of newly diagnosed multiple myeloma has recently been authorized by the European Medicines Agency based on results from three separate phase III randomized, active controlled, open-label studies that have confirmed enhanced efficacy and tolerability in both transplant-ineligible (MMY3008 and MMY3007) and transplant-eligible (MMY3006) patients, without compromising transplant ability. Trial MMY3008 showed an improvement in progression-free survival (PFS) when daratumumab was added to lenalidomide and dexamethasone compared with lenalidomide and dexamethasone; the median PFS had not been reached in the daratumumab arm and was 31.9 months in the control arm (hazard ratio [HR], 0.56; 95% confidence interval [CI], 0.43-0.73; p < .0001). Trial MMY3007 showed an improvement in PFS when daratumumab was added to bortezomib, melphalan, and prednisone compared with bortezomib, melphalan, and prednisone; PFS had not been reached in the daratumumab arm and was 18.1 months in the control arm (HR, 0.5; 95% CI, 0.38-0.65; p < .0001). In trial MMY3006, daratumumab added to bortezomib, thalidomide, and dexamethasone was compared with bortezomib, thalidomide, and dexamethasone as induction and consolidation treatment prior to autologous stem cell transplant. The stringent complete response rate at day 100 after transplant in the daratumumab group was 29% compared with 20% in the control group (odds ratio, 1.60; 1.21-2.12 95% CI; p = .0010). Overall adverse events were manageable, with an increased rate of neutropenia and infections in the daratumumab arms. Regulatory assessment of efficacy and safety results from trials MMY3006, MMY3007, and MMY3008 confirmed a positive benefit-risk ratio leading to an approval of the extensions of indication. IMPLICATIONS FOR PRACTICE: A set of extensions of indication was recently approved for daratumumab (Darzalex) in the setting of newly diagnosed multiple myeloma in combination with established regimens. Results of the MMY3006, MMY3007, and MMY3008 trials have shown enhanced efficacy and a favorable side effect profile of several daratumumab-based combinations in patients both ineligible and eligible for transplant, without compromising transplant ability. The combinations of daratumumab with either lenalidomide and low-dose dexamethasone or bortezomib, melphalan, and prednisone were approved for transplant-ineligible patients. The combination of daratumumab with bortezomib, thalidomide, and dexamethasone was approved for transplant-eligible patients. These combinations are expected to improve the survival outlook for patients with multiple myeloma, without an unacceptable risk of increase in adverse events, and updated information on progression-free survival and overall survival is expected from the above trials.",2020,The stringent Complete Response (sCR) rate at Day 100 post-transplant in the daratumumab group was 29% compared with 20% in the control group [odds ratio (OR):,"['patients with multiple myeloma', 'autologous stem cell transplant', 'adult patients newly diagnosed with multiple myeloma', 'transplant eligible patients', 'newly diagnosed Multiple Myeloma (MM', 'transplant ineligible patients']","['bortezomib, melphalan', 'lenalidomide and low dose dexamethasone or bortezomib, melphalan and prednisone', 'dexamethasone', 'bortezomib, thalidomide and dexamethasone', 'daratumumab (Darzalex', 'bortezomib, melphalan and prednisone']","['stringent Complete Response (sCR) rate', 'rate of neutropenia and infections', 'Overall adverse events', 'survival outlook', 'PFS', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C4058940', 'cui_str': 'Darzalex'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.105223,The stringent Complete Response (sCR) rate at Day 100 post-transplant in the daratumumab group was 29% compared with 20% in the control group [odds ratio (OR):,"[{'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Michaleas', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Penninga', 'Affiliation': 'Danish Medicines Agency, Copenhagen, Denmark.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Hovgaard', 'Affiliation': 'Danish Medicines Agency, Copenhagen, Denmark.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Dalseg', 'Affiliation': 'Danish Medicines Agency, Copenhagen, Denmark.'}, {'ForeName': 'Aldana', 'Initials': 'A', 'LastName': 'Rosso', 'Affiliation': 'Danish Medicines Agency, Copenhagen, Denmark.'}, {'ForeName': 'Sinan B', 'Initials': 'SB', 'LastName': 'Sarac', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Jorge Camarero', 'Initials': 'JC', 'LastName': 'Jimenez', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Lucia López-Anglada', 'Initials': 'LL', 'LastName': 'Fernández', 'Affiliation': 'Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.'}, {'ForeName': 'Carolina Prieto', 'Initials': 'CP', 'LastName': 'Fernández', 'Affiliation': 'Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Mangas-SanJuan', 'Affiliation': 'Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Garcia', 'Affiliation': 'Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.'}, {'ForeName': 'Concepcion', 'Initials': 'C', 'LastName': 'Payares-Herrera', 'Affiliation': 'Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.'}, {'ForeName': 'Aranzazu', 'Initials': 'A', 'LastName': 'Sancho-López', 'Affiliation': 'Instituto de Investigación Hospital Puerta de Hierro-Majadahonda, Madrid, Spain.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Enzmann', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Marcia Sofia Sanches', 'Initials': 'MSS', 'LastName': 'de Castro Lopes Silva', 'Affiliation': 'Pharmacovigilance Risk Assessment Committee (PRAC), Amsterdam, The Netherlands.'}, {'ForeName': 'Sílvia', 'Initials': 'S', 'LastName': 'Duarte', 'Affiliation': 'Pharmacovigilance Risk Assessment Committee (PRAC), Amsterdam, The Netherlands.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pignatti', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}]",The oncologist,['10.1002/onco.13554']
2011,33023671,A Randomized Open label Phase-II Clinical Trial with or without Infusion of Plasma from Subjects after Convalescence of SARS-CoV-2 Infection in High-Risk Patients with Confirmed Severe SARS-CoV-2 Disease (RECOVER): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


Primary objectives • To assess the time from randomisation until an improvement within 84 days defined as two points on a seven point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of SARS-CoV-2 infection or standard of care. Secondary objectives • To assess overall survival, and the overall survival rate at 28 56 and 84 days. • To assess SARS-CoV-2 viral clearance and load as well as antibody titres. • To assess the percentage of patients that required mechanical ventilation. • To assess time from randomisation until discharge.
TRIAL DESIGN


Randomised, open-label, multicenter phase II trial, designed to assess the clinical outcome of SARS-CoV-2 disease in high-risk patients (group 1 to group 4) following treatment with anti-SARS-CoV-2 convalescent plasma or standard of care.
PARTICIPANTS


High-risk patients >18 years of age hospitalized with SARS-CoV-2 infection in 10-15 university medical centres will be included. High-risk is defined as SARS-CoV-2 positive infection with Oxygen saturation at ≤ 94% at ambient air with additional risk features as categorised in 4 groups: • Group 1, pre-existing or concurrent hematological malignancy and/or active cancer therapy (incl. chemotherapy, radiotherapy, surgery) within the last 24 months or less. • Group 2, chronic immunosuppression not meeting the criteria of group 1. • Group 3, age ≥ 50 - 75 years meeting neither the criteria of group 1 nor group 2 and at least one of these criteria: Lymphopenia < 0.8 x G/l and/or D-dimer > 1μg/mL. • Group 4, age ≥ 75 years meeting neither the criteria of group 1 nor group 2. Observation time for all patients is expected to be at least 3 months after entry into the study. Patients receive convalescent plasma for two days (day 1 and day 2) or standard of care. For patients in the standard arm, cross over is allowed from day 10 in case of not improving or worsening clinical condition. Nose/throat swabs for determination of viral load are collected at day 0 and day 1 (before first CP administration) and subsequently at day 2, 3, 5, 7, 10, 14, 28 or until discharge. Serum for SARS-Cov-2 diagnostic is collected at baseline and subsequently at day 3, 7, 14 and once during the follow-up period (between day 35 and day 84). There is a regular follow-up of 3 months. All discharged patients are followed by regular phone calls. All visits, time points and study assessments are summarized in the Trial Schedule (see full protocol Table 1). All participating trial sites will be supplied with study specific visit worksheets that list all assessments and procedures to be completed at each visit. All findings including clinical and laboratory data are documented by the investigator or an authorized member of the study team in the patient's medical record and in the electronic case report forms (eCRFs).
INTERVENTION AND COMPARATOR


This trial will analyze the effects of convalescent plasma from recovered subjects with SARS-CoV-2 antibodies in high-risk patients with SARS-CoV-2 infection. Patients at high risk for a poor outcome due to underlying disease, age or condition as listed above are eligible for enrollment. In addition, eligible patients have a confirmed SARS-CoV-2 infection and O 2  saturation ≤ 94% while breathing ambient air. Patients are randomised to receive (experimental arm) or not receive (standard arm) convalescent plasma in two bags (238 - 337 ml plasma each) from different donors (day 1, day 2). A cross over from the standard arm into the experimental arm is possible after day 10 in case of not improving or worsening clinical condition.
MAIN OUTCOMES


Primary endpoints: The main purpose of the study is to assess the time from randomisation until an improvement within 84 days defined as two points on a seven-point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of a SARS-CoV-2 infection or standard of care. Secondary endpoints: • Overall survival, defined as the time from randomisation until death from any cause 28-day, 56-day and 84-day overall survival rates. • SARS-CoV-2 viral clearance and load as well as antibody titres. • Requirement mechanical ventilation at any time during hospital stay (yes/no). • Time until discharge from randomisation. • Viral load, changes in antibody titers and cytokine profiles are analysed in an exploratory manner using paired non-parametric tests (before - after treatment).
RANDOMISATION


Upon confirmation of eligibility (patients must meet all inclusion criteria and must not meet exclusion criteria described in section 5.3 and 5.4 of the full protocol), the clinical site must contact a centralized internet randomization system ( https://randomizer.at/ ). Patients are randomized using block randomisation to one of the two arms, experimental arm or standard arm, in a 1:1 ratio considering a stratification according to the 4 risk groups (see Participants).
BLINDING (MASKING)


The study is open-label, no blinding will be performed.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


A total number of 174 patients is required for the entire trial, n=87 per group.
TRIAL STATUS


Protocol version 1.2 dated 09/07/2020. A recruitment period of approximately 9 months and an overall study duration of approximately 12 months is anticipated. Recruitment of patients starts in the third quarter of 2020. The study duration of an individual patient is planned to be 3 months. After finishing all study-relevant procedures, therapy, and follow-up period, the patient is followed in terms of routine care and treated if necessary. Total trial duration: 18 months Duration of the clinical phase: 12 months First patient first visit (FPFV): 3 rd  Quarter 2020 Last patient first visit (LPFV): 2 nd  Quarter 2021 Last patient last visit (LPLV): 3 rd  Quarter 2021 Trial Report completed: 4 th  Quarter 2021 TRIAL REGISTRATION: EudraCT Number: 2020-001632-10, https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001632-10/DE , registered on 04/04/2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2). The eCRF is attached (Additional file 3).",2020,Lymphopenia < 0.8 x G/l and/or D-dimer,"['subjects with SARS-CoV-2 antibodies in high-risk patients with SARS-CoV-2 infection', 'Group 3, age ≥ 50 - 75 years', '174 patients is required for the entire trial, n=87 per group', 'High-risk patients >18 years of age hospitalized with SARS-CoV-2 infection in 10-15 university medical centres will be included', 'Subjects after Convalescence of SARS-CoV-2 Infection in High-Risk Patients with Confirmed Severe SARS-CoV-2 Disease (RECOVER', 'Quarter 2021', 'Patients at high risk for a poor outcome due to underlying disease, age or condition as listed above are eligible for enrollment']","['chemotherapy, radiotherapy, surgery', 'anti-SARS-CoV-2 convalescent plasma or standard of care', 'Requirement mechanical ventilation']","['SARS-CoV-2 viral clearance and load as well as antibody titres', 'time from randomisation until an improvement within 84 days defined as two points on a seven-point ordinal scale or live discharge from the hospital', 'Overall survival', 'Viral load, changes in antibody titers and cytokine profiles', 'Observation time', 'overall survival rate', 'overall survival', 'overall survival rates']","[{'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009940', 'cui_str': 'Convalescence'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.193679,Lymphopenia < 0.8 x G/l and/or D-dimer,"[{'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Janssen', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany. maike.janssen@med.uni-heidelberg.de.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schäkel', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Djuka Fokou', 'Affiliation': 'NCT-Trial Center, National Center of Tumor Diseases, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Krisam', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Stermann', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kriegsmann', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Haberbosch', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Jan Philipp', 'Initials': 'JP', 'LastName': 'Novotny', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Weber', 'Affiliation': 'Division of Tropical Medicine, Department of Infectious Diseases, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vehreschild', 'Affiliation': 'Division of Tropical Medicine, Department of Infectious Diseases, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bornhäuser', 'Affiliation': 'University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bullinger', 'Affiliation': 'Charité University Medicine, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schmitt', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Liebregts', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dreger', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Hanns-Martin', 'Initials': 'HM', 'LastName': 'Lorenz', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Plaszczyca', 'Affiliation': 'Department of Infectious Diseases, Molecular Virology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Bartenschlager', 'Affiliation': 'Department of Infectious Diseases, Molecular Virology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Müller', 'Affiliation': 'Department of Infectious Diseases, Virology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Kräusslich', 'Affiliation': 'Department of Infectious Diseases, Virology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Halama', 'Affiliation': 'Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Jäger', 'Affiliation': 'Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Leo', 'Affiliation': 'Institute for Clinical Transfusion Medicine and Cell Therapy Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Meuer', 'Affiliation': 'Institute for Clinical Transfusion Medicine and Cell Therapy Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Weigand', 'Affiliation': 'Department of Anaesthesiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Motsch', 'Affiliation': 'Department of Anaesthesiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Merle', 'Affiliation': 'Department of Internal Medicine IV, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Denkinger', 'Affiliation': 'Division of Tropical Medicine, Department of Infectious Diseases, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Müller-Tidow', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}]",Trials,['10.1186/s13063-020-04735-y']
2012,33030304,Circulating lipids in men with type 2 diabetes following 3 days on a carbohydrate-free diet versus 3 days of fasting.,"OBJECTIVE


We have been interested in determining the effects of dietary changes on fuel metabolism and regulation in men with type 2 diabetes mellitus (T2DM). In this study, the changes in 24-hr circulating lipid profiles were determined when the major fuel source was endogenous versus exogenous fat.
METHODS


Seven males with T2DM were randomized in a crossover design with a 4-week washout period. A standard mixed (control) diet (30%fat:15%protein:55%carbohydrate) was provided initially. Subsequently, a 72-hr (3-day) fast, or a high fat (85%), 15% protein, essentially carbohydrate-free (CHO-free) diet was provided for 72 hr. Triacylglycerol (TAG), non-esterified fatty acids (NEFA), β-hydroxybutyrate (bHB), and insulin-like growth factor-binding protein-1 (IGFBP-1) profiles were determined during the last 24 hr of intervention, as well as during the control diet.
RESULTS


Regardless of the amount of dietary fat (30% vs 85%) and differences in 24-hr profiles, TAG, NEFA, and bHB all returned to the previous basal concentrations within 24 hr. TAGs and NEFAs changed only modestly with fasting; bHB was elevated and increasing. The IGFBP-1 profile was essentially unchanged with either diet but increased with fasting.
CONCLUSION


A CHO-free diet resulted in a large increase in TAG and NEFA versus the control diet; however, both were cleared by the following morning. A negative NEFA profile occurred with the control diet. Thus, mechanisms are present to restore lipid concentrations to their original AM concentrations daily. Fasting resulted in stable concentrations, except for a continuing increase in bHB. Glucose and insulin, common fuel regulators, could not explain the results.",2020,"A CHO-free diet resulted in a large increase in TAG and NEFA versus the control diet; however, both were cleared by the following morning.","['men with type 2 diabetes', 'Seven males with T2DM', 'men with type 2 diabetes mellitus (T2DM']","['standard mixed (control) diet (30%fat:15%protein:55%carbohydrate', 'carbohydrate-free diet']","['Triacylglycerol (TAG), non-esterified fatty acids', 'Circulating lipids', '24-hr circulating lipid profiles', '24-hr profiles, TAG, NEFA, and bHB', 'IGFBP-1 profile', 'NEFA), β-hydroxybutyrate (bHB), and insulin-like growth factor-binding protein-1', 'bHB']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0452308', 'cui_str': 'Carbohydrate-free diet'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0071189', 'cui_str': 'IGFBP1 protein, human'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}]",7.0,0.013052,"A CHO-free diet resulted in a large increase in TAG and NEFA versus the control diet; however, both were cleared by the following morning.","[{'ForeName': 'Frank Q', 'Initials': 'FQ', 'LastName': 'Nuttall', 'Affiliation': 'Section of Endocrinology, Metabolism & Nutrition, and the Metabolic Research Laboratory, Minneapolis VA Health Care System, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Rami M', 'Initials': 'RM', 'LastName': 'Almokayyad', 'Affiliation': 'Section of Endocrinology, Metabolism & Nutrition, and the Metabolic Research Laboratory, Minneapolis VA Health Care System, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Gannon', 'Affiliation': 'Section of Endocrinology, Metabolism & Nutrition, and the Metabolic Research Laboratory, Minneapolis VA Health Care System, University of Minnesota, Minneapolis, MN, USA.'}]",Physiological reports,['10.14814/phy2.14569']
2013,33030312,Responding to the ECHO trial results: modelling the potential impact of changing contraceptive method mix on HIV and reproductive health in South Africa.,"INTRODUCTION


Some observational data suggest that the progestogen injectable contraceptive depot medroxyprogesterone acetate (DMPA) may increase a woman's risk of HIV acquisition but a randomized clinical trial did not find a statistically significant increase in HIV risk for women using DMPA compared to two other methods. However, it could not rule out up to 30% increased HIV risk for DMPA users. We evaluate changes to contraceptive method mix in South Africa under different assumptions about the existence and strength of a possible undetected relationship between DMPA use and HIV risk.
METHODS


A mathematical model was developed to simulate the ongoing HIV epidemic and contraceptive method mix in South Africa to estimate how changes in method mix could impact HIV- and reproductive health-related outcomes. We made different assumptions about the relationship between DMPA use and HIV risk, from no relationship to a 30% increase in HIV risk for women using DMPA. Scenario analyses were used to investigate the impact of switching away from DMPA predominance to new patterns of contraceptive use.
RESULTS


In South Africa, the HIV-related benefits of reduced DMPA use could be as great as the harms of increased adverse reproductive health outcomes over 20 years, if DMPA did increase the risk of HIV acquisition by a relative hazard of infection of 1.1 or greater. A reduction in DMPA use among HIV-positive women would have no benefit in terms of HIV infections, but would incur additional negative reproductive health outcomes. The most important driver of adverse reproductive health outcomes is the proportion of women who switch away from DMPA to no contraceptive method.
CONCLUSIONS


If there is any real increased HIV risk for DMPA users that has not been detected by the recent randomized trial, a reduction in DMPA use could reduce the ongoing number of new HIV infections. However, such a change would place more women at risk of adverse reproductive health effects. It is imperative that these effects are minimized by focusing on expanding access to safe, effective and acceptable alternative contraceptive methods for all women.",2020,"A reduction in DMPA use among HIV-positive women would have no benefit in terms of HIV infections, but would incur additional negative reproductive health outcomes.","['women who switch away from DMPA to no contraceptive method', 'HIV and reproductive health in South Africa']",['progestogen injectable contraceptive depot medroxyprogesterone acetate (DMPA'],"['HIV risk', 'risk of HIV acquisition']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}]","[{'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.260324,"A reduction in DMPA use among HIV-positive women would have no benefit in terms of HIV infections, but would incur additional negative reproductive health outcomes.","[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Beacroft', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Fareed', 'Initials': 'F', 'LastName': 'Abdullah', 'Affiliation': 'Office of AIDS and TB Research, South African Medical Research Council, Pretoria, South Africa.'}, {'ForeName': 'Buyile', 'Initials': 'B', 'LastName': 'Buthelezi', 'Affiliation': 'USAID, Pretoria, South Africa.'}, {'ForeName': 'Manala', 'Initials': 'M', 'LastName': 'Makua', 'Affiliation': 'National Department of Health, Pretoria, South Africa.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Morroni', 'Affiliation': 'Botswana Harvard AIDS Institute, Gaborone, Botswana.'}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Ramjee', 'Affiliation': 'Aurum Institute, Parktown, South Africa.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Velasquez', 'Affiliation': 'UNAIDS Eastern and Southern Africa, Johannesburg, South Africa.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Hallett', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, United Kingdom.'}]",Journal of the International AIDS Society,['10.1002/jia2.25620']
2014,33037801,"The efficacy of etodolac and ibuprofen, regarding gender, on pain, edema and trismus after impacted lower third molar surgery: A randomized prospective clinical split-mouth study.","BACKGROUND


This study aimed to conduct a randomized prospective study about the efficacy of etodolac and ibuprofen on trismus, pain and edema regarding gender of patients submitted to impacted lower third molar teeth extraction.
MATERIAL AND METHODS


Thirty patients aging between 16 and 35 year-old were submitted to the exodontia of impacted lower third molars. During the postoperative period, patients received nine ibuprofen (600 mg) or etodolac (300 mg) pills via oral administration immediately after surgery and repeated doses every eight hours during three days. Patients were evaluated regarding pain, trismus and edema.
RESULTS


Sixteen men and fourteen women participated of the study. No statistical difference was established regarding gender according to the evaluated parameters. However, etodolac use showed better results regarding pain, trismus and edema.
CONCLUSIONS


Pain, edema and trismus after impacted third molars extraction were not influenced by gender.",2020,No statistical difference was established regarding gender according to the evaluated parameters.,"['after impacted lower third molar surgery', 'trismus, pain and edema regarding gender of patients submitted to impacted lower third molar teeth extraction', 'Sixteen men and fourteen women participated of the study', 'Thirty patients aging between 16 and 35 year-old were submitted to the exodontia of impacted lower third molars']","['nine ibuprofen', 'etodolac', 'etodolac and ibuprofen']","['pain, edema and trismus', 'pain, trismus and edema', 'Pain, edema and trismus']","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0059865', 'cui_str': 'Etodolac'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}]",30.0,0.0266139,No statistical difference was established regarding gender according to the evaluated parameters.,"[{'ForeName': 'L-D', 'Initials': 'LD', 'LastName': 'Silva', 'Affiliation': 'José Bonifácio street number 1193,\nAraçatuba, São Paulo, Brazil,16015-050'}, {'ForeName': 'E-N', 'Initials': 'EN', 'LastName': 'Reis', 'Affiliation': ''}, {'ForeName': 'L-P', 'Initials': 'LP', 'LastName': 'Faverani', 'Affiliation': ''}, {'ForeName': 'A-P', 'Initials': 'AP', 'LastName': 'Farnezi Bassi', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.24082']
2015,33035194,A proof-of-concept study on the impact of a chronic pain and physical activity training workshop for exercise professionals.,"Objectives Physical activity is essential for long-term chronic pain management, yet individuals struggle to participate. Exercise professionals, including fitness instructors, and personal trainers, are preferred delivery agents for education and instruction on chronic pain, physical activity, and strategies to use adherence-promoting behavioral skills. However, exercise professionals receive no relevant training during certification or continuing education opportunities to effectively support their participants living with chronic pain. Based on the ORBIT model for early pre-efficacy phases of development and testing of new behavioral treatments, the present Phase IIa proof-of-concept study was conducted. The purpose was to examine the impacts of a newly developed chronic pain and physical activity training workshop on psychosocial outcomes among exercise professionals. Outcomes included knowledge and attitudes regarding chronic pain, attitudes and beliefs about the relationship between pain and impairment, and self-efficacy to educate and instruct participants with chronic pain. Methods Forty-eight exercise professionals (M age=44.4±11.0 years) participated in a three-hour, in-person workshop that was offered at one of four different locations. Participants completed pre- and post-workshop outcome assessment surveys. Results Mixed MANOVA results comparing time (pre- versus post-workshop) by workshop location (sites 1 to 4) illustrated a significant within-subjects time effect (p<0.001). All outcomes significantly improved from pre- to post-workshop (p's<0.001), demonstrating large effect sizes (partial eta-squared values ranging from 0.45 to 0.59). Conclusions Findings offer early phase preliminary support for the effectiveness of the chronic pain and physical activity training workshop for exercise professionals. Based on ORBIT model recommendations, findings warrant future phased testing via a pilot randomized clinical trial as well as testing for impacts that trained professionals have on activity adherence among their clients living with chronic pain. Eventual workshop adoption by exercise professional certification organizations would ensure widespread and sustainable access to qualified exercise professionals to help individuals engage in physical activity. By increasing the capacity of available exercise professionals to deliver effective support, active individuals could better manage their chronic pain and live well.",2020,"All outcomes significantly improved from pre- to post-workshop (p's<0.001), demonstrating large effect sizes (partial eta-squared values ranging from 0.45 to 0.59).","['participants living with chronic pain', 'clients living with chronic pain']","['physical activity training workshop', 'exercise professionals receive no relevant training during certification or continuing education opportunities']","['knowledge and attitudes regarding chronic pain, attitudes and beliefs about the relationship between pain and impairment, and self-efficacy to educate and instruct participants with chronic pain', 'chronic pain, physical activity, and strategies to use adherence-promoting behavioral skills']","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0013626', 'cui_str': 'Continuing Education'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",48.0,0.0595817,"All outcomes significantly improved from pre- to post-workshop (p's<0.001), demonstrating large effect sizes (partial eta-squared values ranging from 0.45 to 0.59).","[{'ForeName': 'Nancy C', 'Initials': 'NC', 'LastName': 'Gyurcsik', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Tupper', 'Affiliation': 'Pain Quality Improvement and Research for the Saskatchewan Health Authority, Saskatoon, SK, Canada.'}, {'ForeName': 'Danielle R', 'Initials': 'DR', 'LastName': 'Brittain', 'Affiliation': 'University of Northern Colorado, College of Natural and Health Sciences, Greeley, CO, USA.'}, {'ForeName': 'Lawrence R', 'Initials': 'LR', 'LastName': 'Brawley', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Miranda A', 'Initials': 'MA', 'LastName': 'Cary', 'Affiliation': 'University of British Columbia, School of Health and Exercise Science, Kelowna, BC, Canada.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Ratcliffe-Smith', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Jocelyn E', 'Initials': 'JE', 'LastName': 'Blouin', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Mackenzie G', 'Initials': 'MG', 'LastName': 'Marchant', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Sessford', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Laurie-Ann M', 'Initials': 'LM', 'LastName': 'Hellsten', 'Affiliation': 'University of Winnipeg, Faculty of Education, Winnipeg, MB, Canada.'}, {'ForeName': 'Bart E', 'Initials': 'BE', 'LastName': 'Arnold', 'Affiliation': 'University of British Columbia, School of Health and Exercise Science, Kelowna, BC, Canada.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Downe', 'Affiliation': 'University of Saskatchewan, Department of Archaeology and Anthropology, Saskatoon, SK, Canada.'}]",Scandinavian journal of pain,['10.1515/sjpain-2020-0089']
2016,33035202,Comparison Between Percutaneous Transforaminal Endoscopic Discectomy and Fenestration in the Treatment of Degenerative Lumbar Spinal Stenosis.,"BACKGROUND This study aimed to investigate the therapeutic and prognostic effects of percutaneous transforaminal endoscopic decompression (PTED) for degenerative lumbar spinal stenosis (DLSS). MATERIAL AND METHODS One hundred eighty-eight patients with DLSS were randomly divided into the fenestration and the PTED group for decompression treatment. Operative time, incision length, amount of blood loss, length of hospitalization, and rates of complications in the 2 groups were compared. All patients underwent computed tomography (CT) scanning and magnetic resonance imaging (MRI) on the first postoperative day. All patients were assessed preoperatively and the treatment effects at 3, 6, and 12 months postoperatively were evaluated using visual analog scale (VAS), Japanese Orthopedic Association Score (JOA) and Oswestry Disability Index (ODI). The modified MacNab criteria were used to assess patient satisfaction 1 year after surgery at the last follow-up. RESULTS Patients who underwent PTED had shorter incisions, less blood loss, and shorter hospital stays than those in the fenestration group, but operative times and complication rates were similar in the 2 groups. Moreover, CT scanning and MRI revealed similar treatment effects in the 2 groups. Compared with preoperative status, improvements in VAS, ODI, and JOA scores occurred at different times after surgery in the 2 groups. In particular, all 3 scores in the PTED group were higher than those in the fenestration group at 3 and 6 months postoperatively. There were no significant differences in MacNab scores between the 2 groups. CONCLUSIONS PTED is safer and more effective than traditional fenestration for management of DLSS.",2020,"Compared with preoperative status, improvements in VAS, ODI, and JOA scores occurred at different times after surgery in the 2 groups.","['Degenerative Lumbar Spinal Stenosis', 'One hundred eighty-eight patients with DLSS', 'degenerative lumbar spinal stenosis (DLSS']","['computed tomography (CT) scanning and magnetic resonance imaging (MRI', 'percutaneous transforaminal endoscopic decompression (PTED', 'Percutaneous Transforaminal Endoscopic Discectomy and Fenestration']","['VAS, ODI, and JOA scores', 'operative times and complication rates', 'visual analog scale (VAS), Japanese Orthopedic Association Score (JOA) and Oswestry Disability Index (ODI', 'MacNab scores', 'Operative time, incision length, amount of blood loss, length of hospitalization, and rates of complications', 'blood loss, and shorter hospital stays']","[{'cui': 'C0410636', 'cui_str': 'Degenerative lumbar spinal stenosis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0015825', 'cui_str': 'Inner ear fenestration'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",188.0,0.0207879,"Compared with preoperative status, improvements in VAS, ODI, and JOA scores occurred at different times after surgery in the 2 groups.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Hengjie', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Jixiang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Yinming', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Chengcun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.926631']
2017,33035206,Impact of providing free HIV self-testing kits on frequency of testing among men who have sex with men and their sexual partners in China: A randomized controlled trial.,"BACKGROUND


The HIV epidemic is rapidly growing among men who have sex with men (MSM) in China, yet HIV testing remains suboptimal. We aimed to determine the impact of HIV self-testing (HIVST) interventions on frequency of HIV testing among Chinese MSM and their sexual partners.
METHODS AND FINDINGS


This randomized controlled trial was conducted in 4 cities in Hunan Province, China. Sexually active and HIV-negative MSM were recruited from communities and randomly assigned (1:1) to intervention or control arms. Participants in the control arm had access to site-based HIV testing (SBHT); those in the intervention arm were provided with 2 free finger-prick-based HIVST kits at enrollment and could receive 2 to 4 kits delivered through express mail every 3 months for 1 year in addition to SBHT. They were encouraged to distribute HIVST kits to their sexual partners. The primary outcome was the number of HIV tests taken by MSM participants, and the secondary outcome was the number of HIV tests taken by their sexual partners during 12 months of follow-up. The effect size for the primary and secondary outcomes was evaluated as the standardized mean difference (SMD) in testing frequency between intervention and control arms. Between April 14, 2018, and June 30, 2018, 230 MSM were recruited. Mean age was 29 years; 77% attended college; 75% were single. The analysis population who completed at least one follow-up questionnaire included 110 (93%, 110/118) in the intervention and 106 (95%, 106/112) in the control arm. The average frequency of HIV tests per participant in the intervention arm (3.75) was higher than that in the control arm (1.80; SMD 1.26; 95% CI 0.97-1.55; P < 0.001). This difference was mainly due to the difference in HIVST between the 2 arms (intervention 2.18 versus control 0.41; SMD 1.30; 95% CI 1.01-1.59; P < 0.001), whereas the average frequency of SBHT was comparable (1.57 versus 1.40, SMD 0.14; 95% CI -0.13 to 0.40; P = 0.519). The average frequency of HIV tests among sexual partners of each participant was higher in intervention than control arm (2.65 versus 1.31; SMD 0.64; 95% CI 0.36-0.92; P < 0.001), and this difference was also due to the difference in HIVST between the 2 arms (intervention 1.41 versus control 0.36; SMD 0.75; 95% CI 0.47-1.04; P < 0.001) but not SBHT (1.24 versus 0.96; SMD 0.23; 95% CI -0.05 to 0.50; P = 0.055). Zero-inflated Poisson regression analyses showed that the likelihood of taking HIV testing among intervention participants were 2.1 times greater than that of control participants (adjusted rate ratio [RR] 2.10; 95% CI 1.75-2.53, P < 0.001), and their sexual partners were 1.55 times more likely to take HIV tests in the intervention arm compared with the control arm (1.55, 1.23-1.95, P < 0.001). During the study period, 3 participants in the intervention arm and none in the control arm tested HIV positive, and 8 sexual partners of intervention arm participants also tested positive. No other adverse events were reported. Limitations in this study included the data on number of SBHT were solely based on self-report by the participants, but self-reported number of HIVST in the intervention arm was validated; the number of partner HIV testing was indirectly reported by participants because of difficulties in accessing each of their partners.
CONCLUSIONS


In this study, we found that providing free HIVST kits significantly increased testing frequency among Chinese MSM and effectively enlarged HIV testing coverage by enhancing partner HIV testing through distribution of kits within their sexual networks.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR1800015584.",2020,"The average frequency of HIV tests among sexual partners of each participant was higher in intervention than control arm (2.65 versus 1.31; SMD 0.64; 95% CI 0.36-0.92; P < 0.001), and this difference was also due to the difference in HIVST between the 2 arms (intervention 1.41 versus control 0.36; SMD 0.75; 95% CI 0.47-1.04; P < 0.001) but not SBHT (1.24 versus 0.96; SMD 0.23; 95% CI -0.05 to 0.50; P = 0.055).","['3 participants in the intervention arm and none in the control arm tested HIV positive, and 8 sexual partners of intervention arm participants also tested positive', 'Chinese MSM and their sexual partners', 'men who have sex with men and their sexual partners in China', '4 cities in Hunan Province, China', 'men who have sex with men (MSM) in China', 'Between April 14, 2018, and June 30, 2018, 230 MSM were recruited', 'Sexually active and HIV-negative MSM', 'Mean age was 29 years; 77% attended college; 75% were single']","['free HIV self-testing kits', '2 free finger-prick-based HIVST kits at enrollment and could receive 2 to 4 kits delivered through express mail every 3 months for 1 year in addition to SBHT', 'HIV self-testing (HIVST) interventions']","['frequency of HIV testing', 'number of HIV tests', 'HIVST', 'number of HIV tests taken by their sexual partners', 'adverse events', 'access to site-based HIV testing (SBHT', 'average frequency of SBHT', 'average frequency of HIV tests', 'likelihood of taking HIV testing']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",230.0,0.169548,"The average frequency of HIV tests among sexual partners of each participant was higher in intervention than control arm (2.65 versus 1.31; SMD 0.64; 95% CI 0.36-0.92; P < 0.001), and this difference was also due to the difference in HIVST between the 2 arms (intervention 1.41 versus control 0.36; SMD 0.75; 95% CI 0.47-1.04; P < 0.001) but not SBHT (1.24 versus 0.96; SMD 0.23; 95% CI -0.05 to 0.50; P = 0.055).","[{'ForeName': 'Ci', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Xiangya School of Nursing, Central South University, Changsha, Hunan Province, China.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Koniak-Griffin', 'Affiliation': 'School of Nursing, University of California at Los Angeles, Los Angeles, California, United States of America.'}, {'ForeName': 'Han-Zhu', 'Initials': 'HZ', 'LastName': 'Qian', 'Affiliation': 'Xiangya School of Nursing, Central South University, Changsha, Hunan Province, China.'}, {'ForeName': 'Lloyd A', 'Initials': 'LA', 'LastName': 'Goldsamt', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, New York, United States of America.'}, {'ForeName': 'Honghong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Xiangya School of Nursing, Central South University, Changsha, Hunan Province, China.'}, {'ForeName': 'Mary-Lynn', 'Initials': 'ML', 'LastName': 'Brecht', 'Affiliation': 'School of Nursing, University of California at Los Angeles, Los Angeles, California, United States of America.'}, {'ForeName': 'Xianhong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Xiangya School of Nursing, Central South University, Changsha, Hunan Province, China.'}]",PLoS medicine,['10.1371/journal.pmed.1003365']
2018,33035228,Influence of COVID-19 confinement on students' performance in higher education.,"This study analyzes the effects of COVID-19 confinement on the autonomous learning performance of students in higher education. Using a field experiment with 458 students from three different subjects at Universidad Autónoma de Madrid (Spain), we study the differences in assessments by dividing students into two groups. The first group (control) corresponds to academic years 2017/2018 and 2018/2019. The second group (experimental) corresponds to students from 2019/2020, which is the group of students that had their face-to-face activities interrupted because of the confinement. The results show that there is a significant positive effect of the COVID-19 confinement on students' performance. This effect is also significant in activities that did not change their format when performed after the confinement. We find that this effect is significant both in subjects that increased the number of assessment activities and subjects that did not change the student workload. Additionally, an analysis of students' learning strategies before confinement shows that students did not study on a continuous basis. Based on these results, we conclude that COVID-19 confinement changed students' learning strategies to a more continuous habit, improving their efficiency. For these reasons, better scores in students' assessment are expected due to COVID-19 confinement that can be explained by an improvement in their learning performance.",2020,We find that this effect is significant both in subjects that increased the number of assessment activities and subjects that did not change the student workload.,"['students in higher education', ""students' performance in higher education"", '458 students from three different subjects at Universidad Autónoma de Madrid (Spain']",['COVID-19 confinement'],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0578816', 'cui_str': 'In higher education'}, {'cui': 'C5191377', 'cui_str': '458'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",[],458.0,0.0202627,We find that this effect is significant both in subjects that increased the number of assessment activities and subjects that did not change the student workload.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gonzalez', 'Affiliation': 'Biochemistry Department, Faculty of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'de la Rubia', 'Affiliation': 'Chemical Engineering Department, Faculty of Sciences, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Hincz', 'Affiliation': 'Escuela Politécnica Superior, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Comas-Lopez', 'Affiliation': 'Escuela Politécnica Superior, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Subirats', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Santi', 'Initials': 'S', 'LastName': 'Fort', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Barcelona, Spain.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Sacha', 'Affiliation': 'Escuela Politécnica Superior, Universidad Autónoma de Madrid, Madrid, Spain.'}]",PloS one,['10.1371/journal.pone.0239490']
2019,33036366,Biopsy-Controlled Non-Invasive Quantification of Collagen Type VI in Kidney Transplant Recipients: A Post-Hoc Analysis of the MECANO Trial.,"The PRO-C6 assay, a reflection of collagen type VI synthesis, has been proposed as a non-invasive early biomarker of kidney fibrosis. We aimed to investigate cross-sectional and longitudinal associations between plasma and urine PRO-C6 and proven histological changes after kidney transplantation. The current study is a post-hoc analysis of 94 participants of the MECANO trial, a 24-month prospective, multicenter, open-label, randomized, controlled trial aimed at comparing everolimus-based vs. cyclosporine-based immunosuppression. PRO-C6 was measured in plasma and urine samples collected 6 and 24 months post-transplantation. Fibrosis was evaluated in biopsies collected at the same time points by Banff interstitial fibrosis/tubular atrophy (IF/TA) scoring and collagen staining (Picro Sirius Red; PSR); inflammation was evaluated by the tubulo-interstitial inflammation score (ti-score). Linear regression analyses were performed. Six-month plasma PRO-C6 was cross-sectionally associated with IF/TA score (Std. β = 0.34), and prospectively with 24-month IF/TA score and ti-score (Std. β = 0.24 and 0.23, respectively) ( p  < 0.05 for all). No significant associations were found between urine PRO-C6 and any of the biopsy findings. Fibrotic changes and urine PRO-C6 behaved differentially over time according to immunosuppressive therapy. These results are a first step towards non-invasive fibrosis detection after kidney transplantation by means of collagen VI synthesis measurement, and further research is required.",2020,Fibrotic changes and urine PRO-C6 behaved differentially over time according to immunosuppressive therapy.,"['kidney transplantation', 'Kidney Transplant Recipients', '94 participants of the MECANO trial']",['everolimus-based vs. cyclosporine-based immunosuppression'],"['PRO-C6', 'urine PRO-C6', 'collagen staining (Picro Sirius Red; PSR); inflammation', 'Fibrotic changes and urine PRO-C6', '24-month IF/TA score and ti-score']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3887486', 'cui_str': 'Interstitial fibrosis'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1265831', 'cui_str': 'Interstitial inflammation'}]",94.0,0.0197494,Fibrotic changes and urine PRO-C6 behaved differentially over time according to immunosuppressive therapy.,"[{'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Yepes-Calderón', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Camilo G', 'Initials': 'CG', 'LastName': 'Sotomayor', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Daniel Guldager Kring', 'Initials': 'DGK', 'LastName': 'Rasmussen', 'Affiliation': 'Nordic Bioscience A/S, 2730 Herlev, Denmark.'}, {'ForeName': 'Ryanne S', 'Initials': 'RS', 'LastName': 'Hijmans', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Te Velde-Keyzer', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'van Londen', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'van Dijk', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Arjan', 'Initials': 'A', 'LastName': 'Diepstra', 'Affiliation': 'Department of Pathology and Medical Biology, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Berger', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Morten Asser', 'Initials': 'MA', 'LastName': 'Karsdal', 'Affiliation': 'Nordic Bioscience A/S, 2730 Herlev, Denmark.'}, {'ForeName': 'Frederike J', 'Initials': 'FJ', 'LastName': 'Bemelman', 'Affiliation': 'Department of Nephrology, Amsterdam University Medical Center, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Johan W', 'Initials': 'JW', 'LastName': 'de Fijter', 'Affiliation': 'Department of Nephrology, Leiden University Medical Center, University of Leiden, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Kers', 'Affiliation': 'Amsterdam Institute for Infection and Immunity (AII), Amsterdam UMC, University of Amsterdam, 1098 XH Amsterdam, The Netherlands.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Florquin', 'Affiliation': 'Amsterdam Institute for Infection and Immunity (AII), Amsterdam UMC, University of Amsterdam, 1098 XH Amsterdam, The Netherlands.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Genovese', 'Affiliation': 'Nordic Bioscience A/S, 2730 Herlev, Denmark.'}, {'ForeName': 'Stephan J L', 'Initials': 'SJL', 'LastName': 'Bakker', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Jan-Stephan', 'Initials': 'JS', 'LastName': 'Sanders', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Van Den Born', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}]",Journal of clinical medicine,['10.3390/jcm9103216']
2020,33036371,"Combining Effect and Process Evaluation on European Preschool Children's Snacking Behavior in a Kindergarten-Based, Family-Involved Cluster Randomized Controlled Trial: The ToyBox Study.","This study aimed at (1) studying the effect of the standardized ToyBox intervention on European preschoolers' snacking behavior, and (2) studying whether a higher process evaluation score from teachers and parents/caregivers was associated with a more positive result for preschoolers' snack intake. A sample of 4970 preschoolers (51.4% boys, 4.74 ± 0.44 years) from six European countries provided information on snack intake with the use of a Food Frequency Questionnaire. To investigate the effect of the intervention, multilevel repeated measures analyses were executed for the total sample and the six country-specific samples. Furthermore, questionnaires to measure process evaluation were used to compute a total process evaluation score for teachers and parents/caregivers. No significant intervention effects on preschoolers' snack intake were found (all  p  > 0.003). In general, no different effects of the intervention on snack intake were found according to kindergarten teachers' and parents'/caregivers' process evaluation scores. The lack of effects could be due to limited intervention duration and dose. To induce larger effects on preschoolers' snack intake, a less standardized intervention which is more tailored to the local needs might be needed.",2020,"In general, no different effects of the intervention on snack intake were found according to kindergarten teachers' and parents'/caregivers' process evaluation scores.","['4970 preschoolers (51.4% boys, 4.74 ± 0.44 years) from six European countries provided information on snack intake with the use of a Food Frequency Questionnaire', ""European preschoolers' snacking behavior, and (2"", ""European Preschool Children's Snacking Behavior in a Kindergarten-Based, Family""]",['standardized ToyBox intervention'],"[""preschoolers' snack intake"", 'snack intake']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C4517459', 'cui_str': '0.44'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",4970.0,0.0814874,"In general, no different effects of the intervention on snack intake were found according to kindergarten teachers' and parents'/caregivers' process evaluation scores.","[{'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'De Craemer', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, 9000 Ghent, Belgium.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Verbestel', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, 9000 Ghent, Belgium.'}, {'ForeName': 'Maïté', 'Initials': 'M', 'LastName': 'Verloigne', 'Affiliation': 'Research Foundation Flanders, 1000 Brussels, Belgium.'}, {'ForeName': 'Odysseas', 'Initials': 'O', 'LastName': 'Androutsos', 'Affiliation': 'Department of Nutrition and Dietetics, School of Physical Education, University of Thessaly, Sport Science and Dietetics, 421 00 Trikala, Greece.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Moreno', 'Affiliation': 'Department of Physiatry and Nursing, GENUD (Growth, Exercise, Drinking Behaviour and Development), University of Zaragoza, 50001 Zaragoza, Spain.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Iotova', 'Affiliation': 'Department of Pediatrics, Medical University Varna, 9002 Varna, Bulgaria.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Koletzko', 'Affiliation': ""Dr. von Hauner Children's Hospital, University of Munich Medical Centre, 80337 Munich, Germany.""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Socha', 'Affiliation': ""Children's Memorial Institute, 04-730 Warsaw, Poland.""}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Sciences & Education, Harokopio University, 17778 Athens, Greece.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Cardon', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, 9000 Ghent, Belgium.'}]",International journal of environmental research and public health,['10.3390/ijerph17197312']
2021,33036504,"[A comparative study on the efficacy of transoral vestibular approach, via bilateral areola approach endoscopic and open thyroidectomy on stage T1b papillary thyroid carcinoma].","Objective:  To compare the surgical efficacy and cosmetic satisfaction of the transoral endoscopic thyroidectomy by vestibular approach (TOETVA), endoscopic thyroidectomy via bilateral areola approach (BAA), and open thyroidectomy (OT) in the treatment of papillary thyroid carcinoma (PTC) in stage T1b.  Methods:  A total of 178 patients with PTC in stages pT1bN0M0 and pT1bN1aM0 treated from January 2017 to December 2018 were divided into TOETVA group ( n =59), BAA group ( n =43), and OT group ( n =76). The baseline characteristics, relevant indexes of surgical efficacy and follow-up data were compared between the three groups, and also the surgical efficacy indexes were compared between unilateral lobectomy + central lymph node dissection (unilateral lobectomy subgroup) and bilateral lobectomy + central lymph nodes dissection (total resection subgroup). SPSS 19.0 statistical software was used for data analysis.  Results:  The mean ages of patients in TOETVA group and BAA group were significantly younger than those in OT group, and the proportion of women in TOETVA group and BAA group was significantly higher than that in OT group, all  P <0.05. None of patients in TOETVA and BAA groups were converted to open surgery. Among TOETVA, BAA and OT groups, there were significant differences in the mean operation time [unilateral lobectomy subgroup: (198.0±45.2) min, (162.0±36.9) min and (79.4±28.6) min,  P <0.05; total resection subgroup: (230.0±36.0) min, (219.8±68.1) min and (102.8±40.0) min,  P <0.05], in total drainage volume [unilateral lobectomy subgroup: (195.0±55.6) ml, (178.1±50.4) ml and (127.0±30.1) ml,  P <0.05; total resection subgroup: (221.1±46.7) ml, (245.3±71.2) ml and (137.7±41.6) ml,  P <0.05], and the incidence of subcutaneous ecchymosis in TOETVA group or BAA group was higher than that in the OT group [5.1% (3/59), 11.6% (5/43)  vs.  0, χ(2)=3.952 and 9.225 respectively, both  P <0.05]. The mean level of C-reactive protein in TOETVA group was higher than that in OT group [(16.8±10.7)  vs.  (9.5±6.9),  P <0.05]. Following-up in the third month after surgery between three groups in cosmetic satisfaction scores [(2.7±0.5)  vs.  (2.6±0.7)  vs.  (1.7±0.8)], scar self-consciousness scores (0[0,1]  vs.  1[0,2]  vs.  2[1,2]), and quality of life scores [(9.1±1.1)  vs.  (8.9±1.1)  vs.  (7.5±0.8)], cosmetic satisfaction and quality of life in TOETVA and BAA group were better than that in OT group, in terms of scar self-consciousness: TOETVA<BAA<OT (all  P <0.05). But there were no significant differences in the levels of Tg or TgAb between three groups for total resection subgroup (all  P >0.05). The median follow-up time of the three groups was 25 months (TOETVA group), 28 months (BAA group), and 32 months (OT group) respectively, without disease progression.  Conclusion:  TOETVA and BAA are optional surgical methods for PTC in stages pT1bN0M0 and pT1bN1aM0, with good safety and patient's cosmetic satisfaction.",2020,But there were no significant differences in the levels of Tg or TgAb between three groups for total resection subgroup (all  P >0.05).,"['178 patients with PTC in stages pT1bN0M0 and pT1bN1aM0 treated from January 2017 to December 2018', 'total resection subgroup', 'papillary thyroid carcinoma (PTC) in stage T1b', 'stage T1b papillary thyroid carcinoma']","['unilateral lobectomy + central lymph node dissection (unilateral lobectomy subgroup) and bilateral lobectomy + central lymph nodes dissection', 'BAA', 'transoral vestibular approach, via bilateral areola approach endoscopic and open thyroidectomy', 'transoral endoscopic thyroidectomy by vestibular approach (TOETVA), endoscopic thyroidectomy via bilateral areola approach (BAA), and open thyroidectomy (OT']","['mean level of C-reactive protein', 'mean operation time', 'cosmetic satisfaction scores', 'scar self-consciousness scores', 'cosmetic satisfaction and quality of life', 'surgical efficacy and cosmetic satisfaction', 'levels of Tg or TgAb', 'total drainage volume', 'median follow-up time', 'quality of life scores', 'surgical efficacy indexes', 'incidence of subcutaneous ecchymosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015491', 'cui_str': 'factor IX'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C0475385', 'cui_str': 'Tumor stage T1b'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0222608', 'cui_str': 'Areola structure'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}]",178.0,0.0271133,But there were no significant differences in the levels of Tg or TgAb between three groups for total resection subgroup (all  P >0.05).,"[{'ForeName': 'Z D', 'Initials': 'ZD', 'LastName': 'Liu', 'Affiliation': 'Department of Thyroid Surgery, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'Y J', 'Initials': 'YJ', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid Surgery, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Thyroid Surgery, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Xiang', 'Affiliation': 'Department of Thyroid Surgery, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Thyroid Surgery, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Thyroid Surgery, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou 310009, China.'}]",Zhonghua er bi yan hou tou jing wai ke za zhi = Chinese journal of otorhinolaryngology head and neck surgery,['10.3760/cma.j.cn115330-20200520-00430']
2022,33036505,[Clinical application of the gasless unilateral axillary approach in endoscopic thyroid surgery].,"Objective:  To investigate the efficacy, safety and advantages of gasless unilateral axillary approach (GUAA) in endoscopic thyroid surgery.  Methods:  A total of 334 patients who underwent the GUAA endoscopic thyroid surgery (GUAA group) or conventional open thyroid surgery (OS group) in the Department of Head and Neck Surgery of Zhejiang Cancer Hospital from January 2017 to June 2018 were retrospectively analyzed. There were 45 males and 289 females, aged from 12 to 72 years old, of whom 139 patients were assigned to GUAA group and 195 patients to OS group. Pathological results included papillary thyroid carcinoma (282 cases), nodular goiter (41 cases) and thyroid adenoma (11 cases). Surgical exploration development curve of GUAA group was drawn and was divided into two parts: the technical exploration stage and the technical stable stage. Surgical efficiency, incidences of complications, and incision satisfaction were compared between GUAA group in technical stable stage and OS group. SPSS 25.0 software was adopted for statistical analysis.  Results:  The mean age in GUAA group was younger than that in OS group, with a significant difference [(35.3±9.5) years  vs.  (48.1±10.6) years,  t =11.31,  P <0.01]. The cases in the endoscope group were divided into technical exploration stage for 51 cases and technical stable stage for 88 cases according to the exploration and development curve. In unilateral radical thyroidectomy and unilateral thyroid lobectomy, the mean operation time [(90.6±18.6) min and (93.5±22.0) min] and postoperative drainage volumes [(121.5±87.6) ml and (155.5±69.1) ml] of GUAA group in the stable stage were more than those of OS group [(61.6±15.6) min and (46.5±8.4) min] and [(93.2±42.3) ml and (78.9±48.7) ml]. The difference was statistically significant ( t =12.28, 7.23, 3.35 and 3.05 respectively, all  P <0.05), but there were no significant differences in surgical bleeding volumes between two groups [(12.7±6.8) ml  vs.  (13.5±7.7) ml,  t =0.74,  P >0.05 and (16.3±14.1) ml  vs.  (11.9±5.1) ml,  t =1.05,  P >0.05]. Compared with OS group, GUAA group had the lower incidence of anterior cervical discomfort during swallowing (2.3%  vs.  29.2%,  P <0.01) and the higher incision satisfaction score (1.1±0.5  vs.  2.8±0.7,  t =21.12,  P <0.01), however, GUAA group had the higher incidence of supraclavicular (or infraclavicular) numbness after surgery (5.7%  vs.  0,  P <0.01). And there was no significant difference in the incidences of temporary recurrent laryngeal nerve injury, bleeding, hematoma, infection, lymphatic leakage or chylous leakage after surgery between two groups ( P >0.05).  Conclusion:  GUAA endoscopic thyroid surgery is a safe method with high cosmetic satisfaction.",2020,"And there was no significant difference in the incidences of temporary recurrent laryngeal nerve injury, bleeding, hematoma, infection, lymphatic leakage or chylous leakage after surgery between two groups ( P >0.05).  ","['group and 195 patients to OS group', 'OS group) in the Department of Head and Neck Surgery of Zhejiang Cancer Hospital from January 2017 to June 2018 were retrospectively analyzed', 'endoscopic thyroid surgery', '45 males and 289 females, aged from 12 to 72 years old, of whom 139 patients', 'papillary thyroid carcinoma (282 cases), nodular goiter (41 cases) and thyroid adenoma (11 cases', '334 patients who underwent the']","['GUAA endoscopic thyroid surgery', 'GUAA endoscopic thyroid surgery (GUAA group) or conventional open thyroid surgery', 'unilateral radical thyroidectomy and unilateral thyroid lobectomy', 'GUAA', 'gasless unilateral axillary approach', 'gasless unilateral axillary approach (GUAA']","['incidences of temporary recurrent laryngeal nerve injury, bleeding, hematoma, infection, lymphatic leakage or chylous leakage', 'anterior cervical discomfort during swallowing', 'incidence of supraclavicular (or infraclavicular) numbness', 'mean operation time', 'Surgical efficiency, incidences of complications, and incision satisfaction', 'higher incision satisfaction score', 'surgical bleeding volumes', 'postoperative drainage volumes']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0193769', 'cui_str': 'Operation on thyroid gland'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0018023', 'cui_str': 'Nodular goiter'}, {'cui': 'C0151468', 'cui_str': 'Thyroid adenoma'}, {'cui': 'C4517729', 'cui_str': '334'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0193769', 'cui_str': 'Operation on thyroid gland'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}, {'cui': 'C1562241', 'cui_str': 'Axillary approach'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C2077203', 'cui_str': 'Recurrent Laryngeal Nerve Injury'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0443174', 'cui_str': 'Chylous'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0589496', 'cui_str': 'Supraclavicular approach'}, {'cui': 'C0230108', 'cui_str': 'Infraclavicular region structure'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",139.0,0.0225002,"And there was no significant difference in the incidences of temporary recurrent laryngeal nerve injury, bleeding, hematoma, infection, lymphatic leakage or chylous leakage after surgery between two groups ( P >0.05).  ","[{'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Xu', 'Affiliation': ""Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou 310014, China.""}, {'ForeName': 'L Z', 'Initials': 'LZ', 'LastName': 'Zhang', 'Affiliation': 'Second Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou 310053, China.'}, {'ForeName': 'Q H', 'Initials': 'QH', 'LastName': 'Zhang', 'Affiliation': 'Second Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou 310053, China.'}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Guo', 'Affiliation': ""Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou 310014, China.""}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Tan', 'Affiliation': ""Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou 310014, China.""}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Wang', 'Affiliation': ""Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou 310014, China.""}, {'ForeName': 'L H', 'Initials': 'LH', 'LastName': 'Jiang', 'Affiliation': ""Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou 310014, China.""}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Zheng', 'Affiliation': ""Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou 310014, China.""}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Ge', 'Affiliation': ""Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou 310014, China.""}, {'ForeName': 'X B', 'Initials': 'XB', 'LastName': 'Lan', 'Affiliation': 'Department of Head and Neck Surgery, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou 310022, China.'}]",Zhonghua er bi yan hou tou jing wai ke za zhi = Chinese journal of otorhinolaryngology head and neck surgery,['10.3760/cma.j.cn115330-20200225-00126']
2023,33036588,The contribution of serum cortisone and glucocorticoid metabolites to detrimental bone health in patients receiving hydrocortisone therapy.,"BACKGROUND


Glucocorticoid therapy is the most common cause of iatrogenic osteoporosis. Less is known regarding the effect of glucocorticoids when used as replacement therapy on bone remodelling in patients with adrenal insufficiency. Enhanced intracellular conversion of inactive cortisone to active cortisol, by 11 beta-hydroxysteroid dehydrogenase type 1(11β-HSD1) and other enzymes leading to alterations in glucocorticoid metabolism, may contribute to a deleterious effect on bone health in this patient group.
METHODS


Study design: An open crossover prospective study randomizing ten hypopituitary men, with severe ACTH deficiency, to three commonly used hydrocortisone dose regimens.
MEASUREMENTS


Following 6 weeks of each regimen, patients underwent 24-h serum cortisol/cortisone sampling, measurement of bone turnover markers, and a 24-h urine collection for measurement of urinary steroid metabolites by gas chromatography-mass spectrometry (GC-MS). Serum cortisone and cortisol were analysed by liquid chromatography-mass spectrometry (LC-MS).
RESULTS


Dose-related and circadian variations in serum cortisone were seen to parallel those for cortisol, indicating conversion of ingested hydrocortisone to cortisone. The median area under the curve (AUC) of serum cortisone was significantly higher in patients on dose A (20 mg/10 mg) [670.5 (IQR 621-809.2)] compared to those on dose C (10 mg/5 mg) [562.8 (IQR 520.1-619.6), p = 0.01]. A negative correlation was observed between serum cortisone and bone formation markers, OC [1-49] (r = - 0.42, p = 0.03), and PINP (r = - 0.49, p = 0.01). There was a negative correlation between the AUC of night-time serum cortisone levels with the bone formation marker, OC [1-49] (r = - 0.41, p = 0.03) but there were no significant correlations between day-time serum cortisone or cortisol with bone turnover markers. There was a negative correlation between total urinary cortisol metabolites and the bone formation markers, PINP (r = - 0.39, p = 0.04), and OC [1-49] (r = - 0.35, p = 0.06).
CONCLUSION


Serum cortisol and cortisone and total urinary corticosteroid metabolites are negatively associated with bone turnover markers in patients receiving replacement doses of hydrocortisone, with nocturnal glucocorticoid exposure having a potentially greater influence on bone turnover.
TRIAL REGISTRATION


Irish Medicines Board Clinical Trial Number - CT900/459/1 and EudraCT Number - 2007-005018-37 . Registration date: 07-09-2007.",2020,"Serum cortisol and cortisone and total urinary corticosteroid metabolites are negatively associated with bone turnover markers in patients receiving replacement doses of hydrocortisone, with nocturnal glucocorticoid exposure having a potentially greater influence on bone turnover.
","['ten hypopituitary men, with severe ACTH deficiency, to three commonly used hydrocortisone dose regimens', 'patients with adrenal insufficiency', 'patients receiving hydrocortisone therapy', 'patients receiving replacement doses of']","['glucocorticoids', 'hydrocortisone', 'Glucocorticoid therapy']","['bone health', 'Serum cortisone and cortisol', 'total urinary cortisol metabolites and the bone formation markers, PINP', 'Serum cortisol and cortisone and total urinary corticosteroid metabolites', 'serum cortisone and bone formation markers, OC [1-49] ', 'AUC of night-time serum cortisone levels', 'median area under the curve (AUC) of serum cortisone', 'bone turnover']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0342388', 'cui_str': 'ACTH deficiency'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001623', 'cui_str': 'Hypoadrenalism'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010137', 'cui_str': 'Cortisone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",10.0,0.0281475,"Serum cortisol and cortisone and total urinary corticosteroid metabolites are negatively associated with bone turnover markers in patients receiving replacement doses of hydrocortisone, with nocturnal glucocorticoid exposure having a potentially greater influence on bone turnover.
","[{'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Dineen', 'Affiliation': 'Department of Endocrinology, Tallaght University Hospital, Dublin, Ireland. rosedineen@gmail.com.'}, {'ForeName': 'Lucy-Ann', 'Initials': 'LA', 'LastName': 'Behan', 'Affiliation': 'Department of Endocrinology, Tallaght University Hospital, Dublin, Ireland.'}, {'ForeName': 'Grainne', 'Initials': 'G', 'LastName': 'Kelleher', 'Affiliation': 'Department of Chemical Pathology, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Hannon', 'Affiliation': 'Academic Department of Endocrinology, Beaumont Hospital and Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Brady', 'Affiliation': ""Metabolism Laboratory, St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Bairbre', 'Initials': 'B', 'LastName': 'Rogers', 'Affiliation': 'Academic Department of Endocrinology, Beaumont Hospital and Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Keevil', 'Affiliation': 'Manchester Academic Health Science Centre, University Hospital of South Manchester, The University of Manchester, Manchester, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tormey', 'Affiliation': 'Department of Chemical Pathology, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Diarmuid', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Academic Department of Endocrinology, Beaumont Hospital and Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Thompson', 'Affiliation': 'Academic Department of Endocrinology, Beaumont Hospital and Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Malachi J', 'Initials': 'MJ', 'LastName': 'McKenna', 'Affiliation': ""Metabolism Laboratory, St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Arlt', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Stewart', 'Affiliation': 'Medical School, University of Leeds, Leeds, UK.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Agha', 'Affiliation': 'Academic Department of Endocrinology, Beaumont Hospital and Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sherlock', 'Affiliation': 'Academic Department of Endocrinology, Beaumont Hospital and Royal College of Surgeons in Ireland, Dublin, Ireland.'}]",BMC endocrine disorders,['10.1186/s12902-020-00633-1']
2024,33036591,Self-management and HeAlth Promotion in Early-stage dementia with e-learning for carers (SHAPE): study protocol for a multi-centre randomised controlled trial.,"BACKGROUND


With an increasing number of people with dementia worldwide and limited advancement in medical treatments, the call for new and cost-effective approaches is crucial. The utility of self-management has been proven in certain chronic conditions. However, very little work has been undertaken regarding self-management in people with dementia.
METHODS


The SHAPE trial will include 372 people with mild to moderate dementia to evaluate the effectiveness and cost-effectiveness of an educational programme combining approaches of self-management, health promotion, and e-learning for care partners. The study is a multi-site, single-randomised, controlled, single-blinded trial with parallel arms. The intervention arm is compared with treatment as usual. The intervention comprises a 10-week course delivered as group sessions for the participants with dementia. The sessions are designed to develop self-management skills and to provide information on the nature of the condition and the development of healthy behaviours in a supportive learning environment. An e-learning course will be provided for care partners which covers similar and complementary material to that discussed in the group sessions for the participant with dementia.
DISCUSSION


This trial will explore the effect of the SHAPE group intervention on people with mild to moderate dementia in terms of self-efficacy and improvement in key health and mental health outcomes and cost-effectiveness, along with carer stress and knowledge of dementia.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04286139, registered prospectively February 26, 2020, https://clinicaltrials.gov/ct2/show/NCT04286139.",2020,"This trial will explore the effect of the SHAPE group intervention on people with mild to moderate dementia in terms of self-efficacy and improvement in key health and mental health outcomes and cost-effectiveness, along with carer stress and knowledge of dementia.
","['people with dementia', '372 people with mild to moderate dementia to evaluate the effectiveness and cost-effectiveness of an educational programme combining approaches of self-management, health promotion, and e-learning for care partners', 'Early-stage dementia with e-learning for carers (SHAPE', 'people with mild to moderate dementia']","['SHAPE group intervention', 'Self-management and HeAlth Promotion']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}]","[{'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}]",[],372.0,0.120627,"This trial will explore the effect of the SHAPE group intervention on people with mild to moderate dementia in terms of self-efficacy and improvement in key health and mental health outcomes and cost-effectiveness, along with carer stress and knowledge of dementia.
","[{'ForeName': 'Ingelin', 'Initials': 'I', 'LastName': 'Testad', 'Affiliation': 'Centre for Age-related Medicine - SESAM, Stavanger University Hospital, Stavanger, Norway. itestad@gmail.com.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Clare', 'Affiliation': ""REACH: The Centre for Research in Ageing and Cognitive Health, University of Exeter, St Luke's Campus, Exeter, UK.""}, {'ForeName': 'Kaarin', 'Initials': 'K', 'LastName': 'Anstey', 'Affiliation': 'UNSW Ageing Futures Institute, University of New South Wales, Randwick, Australia.'}, {'ForeName': 'Geir', 'Initials': 'G', 'LastName': 'Selbæk', 'Affiliation': 'Norwegian National Advisory Unit on Ageing and Health, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Guro Hanevold', 'Initials': 'GH', 'LastName': 'Bjørkløf', 'Affiliation': 'Norwegian National Advisory Unit on Ageing and Health, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Henderson', 'Affiliation': 'Care Policy and Evaluation Centre, Department of Health Policy, London School of Economics and Political Science, London, UK.'}, {'ForeName': 'Ingvild', 'Initials': 'I', 'LastName': 'Dalen', 'Affiliation': 'Department of Research, Section of Biostatistics, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Martha Therese', 'Initials': 'MT', 'LastName': 'Gjestsen', 'Affiliation': 'Centre for Age-related Medicine - SESAM, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Rhodes', 'Affiliation': 'University of Exeter, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Røsvik', 'Affiliation': 'Norwegian National Advisory Unit on Ageing and Health, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Bollen', 'Affiliation': 'University of Exeter, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Amos', 'Affiliation': 'UNSW Ageing Futures Institute, University of New South Wales, Randwick, Australia.'}, {'ForeName': 'Martine Marie', 'Initials': 'MM', 'LastName': 'Kajander', 'Affiliation': 'Centre for Age-related Medicine - SESAM, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Quinn', 'Affiliation': 'University of Exeter, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Knapp', 'Affiliation': 'Care Policy and Evaluation Centre, Department of Health Policy, London School of Economics and Political Science, London, UK.'}]",BMC public health,['10.1186/s12889-020-09590-9']
2025,33036605,Implementation of guidelines on family involvement for persons with psychotic disorders in community mental health centres (IFIP): protocol for a cluster randomised controlled trial.,"BACKGROUND


Family involvement for persons with psychotic disorders is under-implemented in mental health care, despite its firm scientific, economic, legal and moral basis. This appears to be the case in Norway, despite the presence of national guidelines providing both general recommendations on family involvement and support in the health- and care services, and specific guidance on family interventions for patients with psychotic disorders. The aim of this project is to improve mental health services and the psychosocial health of persons with psychotic disorders and their relatives, by implementing selected recommendations from the national guidelines in community mental health centres, and to evaluate this process.
METHODS


The trial is cluster randomised, where 14 outpatient clusters from community mental health centres undergo stratified randomisation with an allocation ratio of 1:1. The seven intervention clusters will receive implementation support for 18 months, whereas the control clusters will receive the same support after this implementation period. The intervention consists of: 1. A basic level of family involvement and support. 2. Family psychoeducation in single-family groups. 3. Training and guidance of health care personnel. 4. A family coordinator and 5. Other implementation measures. Fidelity to the intervention will be measured four times in the intervention arm and two times in the control arm, and the differences in fidelity changes between the arms constitute the primary outcomes. In each arm, we aim to include 161 patients with psychotic disorders and their closest relative to fill in questionnaires at inclusion, 6 months and 12 months, measuring psychosocial health and satisfaction with services. Clinicians will contribute clinical data about patients at inclusion and 12 months. Use of health and welfare services and work participation, for both patients and relatives, will be retrieved from national registries. We will also perform qualitative interviews with patients, relatives, health care personnel and leaders. Finally, we will conduct a cost-effectiveness analysis and a political economy analysis.
DISCUSSION


This project, with its multilevel and mixed methods approach, may contribute valuable knowledge to the fields of family involvement, mental health service research and implementation science.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT03869177 . Registered 11.03.19.",2020,"The aim of this project is to improve mental health services and the psychosocial health of persons with psychotic disorders and their relatives, by implementing selected recommendations from the national guidelines in community mental health centres, and to evaluate this process.
","['patients with psychotic disorders', 'persons with psychotic disorders', 'persons with psychotic disorders in community mental health centres (IFIP', '14 outpatient clusters from community mental health centres undergo stratified randomisation with an allocation ratio of 1:1', '161 patients with psychotic disorders and their closest relative to fill in questionnaires at inclusion, 6\u2009months and 12\u2009months, measuring psychosocial health and satisfaction with services', 'persons with psychotic disorders and their relatives, by implementing selected recommendations from the national guidelines in community mental health centres']",[],"['mental health services', 'fidelity changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0557090', 'cui_str': 'Closest relatives'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]",[],"[{'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",161.0,0.0663029,"The aim of this project is to improve mental health services and the psychosocial health of persons with psychotic disorders and their relatives, by implementing selected recommendations from the national guidelines in community mental health centres, and to evaluate this process.
","[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Hestmark', 'Affiliation': 'Centre for Medical Ethics, University of Oslo, Kirkeveien 166 Fredrik Holsts hus, 0450, Oslo, Norway. lars.hestmark@medisin.uio.no.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Romøren', 'Affiliation': 'Centre for Medical Ethics, University of Oslo, Kirkeveien 166 Fredrik Holsts hus, 0450, Oslo, Norway.'}, {'ForeName': 'Kristin Sverdvik', 'Initials': 'KS', 'LastName': 'Heiervang', 'Affiliation': 'Centre for Medical Ethics, University of Oslo, Kirkeveien 166 Fredrik Holsts hus, 0450, Oslo, Norway.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Weimand', 'Affiliation': 'Division of Mental Health Services, Akershus University Hospital, Sykehusveien 25, 1474, Nordbyhagen, Norway.'}, {'ForeName': 'Torleif', 'Initials': 'T', 'LastName': 'Ruud', 'Affiliation': 'Centre for Medical Ethics, University of Oslo, Kirkeveien 166 Fredrik Holsts hus, 0450, Oslo, Norway.'}, {'ForeName': 'Reidun', 'Initials': 'R', 'LastName': 'Norvoll', 'Affiliation': 'Work Research Institute, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Kristiane Myckland', 'Initials': 'KM', 'LastName': 'Hansson', 'Affiliation': 'Centre for Medical Ethics, University of Oslo, Kirkeveien 166 Fredrik Holsts hus, 0450, Oslo, Norway.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Norheim', 'Affiliation': 'Division of Mental Health and Addiction, Vestre Viken Hospital Trust, Lier, Norway.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Aas', 'Affiliation': 'Department of Health Management and Health Economics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Elisabeth Geke Marjan', 'Initials': 'EGM', 'LastName': 'Landeweer', 'Affiliation': 'Centre for Medical Ethics, University of Oslo, Kirkeveien 166 Fredrik Holsts hus, 0450, Oslo, Norway.'}, {'ForeName': 'Reidar', 'Initials': 'R', 'LastName': 'Pedersen', 'Affiliation': 'Centre for Medical Ethics, University of Oslo, Kirkeveien 166 Fredrik Holsts hus, 0450, Oslo, Norway.'}]",BMC health services research,['10.1186/s12913-020-05792-4']
2026,33036638,Octyl-2-cyanoacrylate tissue adhesive without subcuticular suture for wound closure after total hip arthroplasty: a prospective observational study on thirty-two cases with controls for 3 months follow-up.,"BACKGROUND


Whether using tissue adhesive alone after subcutaneous suture can close the skin incision with safety as well as cosmetic appearance after total hip arthroplasty was not clear.
METHODS


A prospective study was conducted. The same surgical methods were consistent throughout the entire study. After implanting prosthesis, the joint capsule was reconstructed. Fascial and subcutaneous layer were respectively closed by continuous running barbed suture. Patients were randomized allocated to group A with octyl-2-cyanoacrylate tissue adhesive alone, to group B with tissue adhesive after continuous subcuticular suture, or to group C with skin staples. Time of closure, drainage, pain, wound complications, and cosmesis were compared. All data were analyzed statistically.
RESULTS


There was no significant difference in drainage, Visual Analog Scale score or early wound complications between the three groups. However, there was significant difference in time of closure (P = 0.013). In pairwise comparison, time of closure in groups A and B was significantly longer than those in group C (P = 0.001 and P = 0.023, respectively); time of closure in group A was significantly shorter than those in group B (P = 0.003). Patient and Observer Scar Assessment Scale total scores were not significantly different at 6 weeks and 3 months postoperatively (P = 0.078 and P = 0.284, respectively).
CONCLUSION


Tissue adhesive without subcuticular suture was similar with a combination of subcuticular suture and tissue adhesive as well skin staples in terms of safety and cosmetic appearance after total hip arthroplasty.",2020,"Patient and Observer Scar Assessment Scale total scores were not significantly different at 6 weeks and 3 months postoperatively (P = 0.078 and P = 0.284, respectively).
","['thirty-two cases with controls for 3\u2009months follow-up', 'wound closure after total hip arthroplasty']","['Tissue adhesive without subcuticular suture', 'Octyl-2-cyanoacrylate tissue adhesive without subcuticular suture', 'octyl-2-cyanoacrylate tissue adhesive alone, to group B with tissue adhesive after continuous subcuticular suture, or to group C with skin staples']","['Fascial and subcutaneous layer', 'Time of closure, drainage, pain, wound complications, and cosmesis', 'time of closure', 'drainage, Visual Analog Scale score or early wound complications', 'Patient and Observer Scar Assessment Scale total scores']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0040277', 'cui_str': 'Tissue adhesives'}, {'cui': 'C0563304', 'cui_str': 'Subcuticular'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0391770', 'cui_str': '2-octyl cyanoacrylate'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C1139841', 'cui_str': 'Skin staple'}]","[{'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0148424,"Patient and Observer Scar Assessment Scale total scores were not significantly different at 6 weeks and 3 months postoperatively (P = 0.078 and P = 0.284, respectively).
","[{'ForeName': 'Li-Shen', 'Initials': 'LS', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedic Surgery, The First Hospital of Jilin University, Changchun, Jilin, 130021, China.'}, {'ForeName': 'Xin-Yu', 'Initials': 'XY', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedic Surgery, The First Hospital of Jilin University, Changchun, Jilin, 130021, China.'}, {'ForeName': 'Hao-Tian', 'Initials': 'HT', 'LastName': 'Tu', 'Affiliation': 'Department of Orthopedic Surgery, The First Hospital of Jilin University, Changchun, Jilin, 130021, China.'}, {'ForeName': 'Yi-Fan', 'Initials': 'YF', 'LastName': 'Huang', 'Affiliation': 'Department of Orthopedic Surgery, The First Hospital of Jilin University, Changchun, Jilin, 130021, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Department of Orthopedic Surgery, The First Hospital of Jilin University, Changchun, Jilin, 130021, China. qixindoc@163.com.'}, {'ForeName': 'Yu-Hang', 'Initials': 'YH', 'LastName': 'Gao', 'Affiliation': 'Department of Orthopedic Surgery, The First Hospital of Jilin University, Changchun, Jilin, 130021, China. gaoyuhangdoc@163.com.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01997-9']
2027,33036645,The effect of early oral stimulation with breast milk on the feeding behavior of infants after congenital cardiac surgery.,"OBJECTIVE


To investigate the effect of early oral stimulation with breast milk on the feeding behavior of infants after congenital cardiac surgery.
METHODS


Infants with congenital heart disease were randomly divided into the breast milk oral stimulation group (n = 23), physiological saline oral stimulation group (n = 23) and control group (n = 23). Debra Beckman's oral exercise program was used with breast milk and physiological saline in the breast milk oral stimulation group and the physiological saline oral stimulation group, respectively. The time oral feeding and total oral nutrition were started, the length of intensive care unit (ICU) stay and hospital stay, weight and the complications at discharge were recorded for each group and statistically analyzed.
RESULTS


The time oral feeding and total oral nutrition were started and the length of ICU stay and hospital stay were significantly less in the breast milk oral stimulation group and physiological saline oral stimulation group than in the control group (P < 0.05). There were no significant differences in other indicators between the breast milk oral stimulation group and the physiological saline oral stimulation group, except for the time total oral nutrition began (P < 0.05). However, there were no significant differences in weight or complications at discharge among the three groups (P > 0.05).
CONCLUSION


Early oral stimulation exercises with breast milk can help infant patients quickly recover total oral nutrition and reduce the length of ICU and hospital stay after cardiac surgery.",2020,"There were no significant differences in other indicators between the breast milk oral stimulation group and the physiological saline oral stimulation group, except for the time total oral nutrition began (P < 0.05).","['Infants with congenital heart disease', 'infants after congenital cardiac surgery']","['breast milk oral stimulation group (n\xa0=\u200923), physiological saline oral stimulation group (n\xa0=\u200923) and control group', ""Debra Beckman's oral exercise program""]","['length of intensive care unit (ICU) stay and hospital stay, weight and the complications at discharge', 'weight or complications', 'length of ICU and hospital stay', 'time total oral nutrition began', 'time oral feeding and total oral nutrition', 'length of ICU stay and hospital stay']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]",,0.0213002,"There were no significant differences in other indicators between the breast milk oral stimulation group and the physiological saline oral stimulation group, except for the time total oral nutrition began (P < 0.05).","[{'ForeName': 'Xian-Rong', 'Initials': 'XR', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Li-Wen', 'Initials': 'LW', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Zeng-Chun', 'Initials': 'ZC', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China. chenqiang2228@163.com.'}]",Journal of cardiothoracic surgery,['10.1186/s13019-020-01355-0']
2028,33036655,Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: study protocol for a parallel group randomized controlled trial.,"BACKGROUND


Depression is a major public health concern. Emerging research has shown that cognitive behavioral therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression. Traditional face-to-face CBT-I encounters many obstacles related to feasibility, accessibility, and help-seeking stigma. CBT-I delivered via smartphone application could be a potential solution. This paper reports a protocol designed to evaluate the efficacy of a self-help smartphone-based CBT-I, using a waitlist group as control, for people with major depression and insomnia.
METHODS


A two-arm parallel randomized controlled trial is conducted in a target sample of 285 non-suicidal Hong Kong Chinese older than 17 years of age with major depression and insomnia. Participants complete an online rapid screening, followed by a telephone diagnostic interview. Those who meet the eligibility criteria are randomized in a ratio of 1:1 to receive either CBT-I immediately or to a waitlist control condition. The CBT-I consists of six weekly modules and is delivered through a smartphone application proACT-S. This smartphone app has been pilot tested and revamped to improve user experience. An online randomized algorithm is used to perform randomization to ensure allocation concealment. The primary outcomes are changes over the measurement points in sleep quality, insomnia severity, and depression severity. The secondary outcomes include changes over the measurement points in anxiety, subjective health, treatment expectancy, and acceptability of treatment. Assessments are administered at baseline, post-intervention, and 6-week follow-up. The recruitment is completed. Important adverse events, if any, are documented. Multilevel linear mixed model based on intention-to-treat principle will be conducted to examine the efficacy of the CBT-I intervention.
DISCUSSION


It is expected that proACT-S is an efficacious brief sleep-focused self-help treatment for people with major depression and insomnia. If proven efficacious, due to its self-help nature, proACT-S may be applicable as a community-based early intervention, thereby reducing the burden of the public healthcare system in Hong Kong.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04228146 . Retrospectively registered on 14 January 2020.",2020,Emerging research has shown that cognitive behavioral therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression.,"['Retrospectively registered on 14 January 2020', 'people with major depression and insomnia', '285 non-suicidal Hong Kong Chinese older than 17\u2009years of age with major depression and insomnia', 'individuals with comorbid insomnia and depression']","['smartphone application proACT-S', 'CBT-I delivered via smartphone application', 'self-help smartphone-based CBT-I', 'CBT-I immediately or to a waitlist control condition', 'smartphone-delivered self-help cognitive behavioral therapy', 'cognitive behavioral therapy']","['changes over the measurement points in sleep quality, insomnia severity, and depression severity', 'changes over the measurement points in anxiety, subjective health, treatment expectancy, and acceptability of treatment']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2936631', 'cui_str': 'Subjective Health Complaint'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",285.0,0.0880273,Emerging research has shown that cognitive behavioral therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression.,"[{'ForeName': 'Victoria Ka-Ying', 'Initials': 'VK', 'LastName': 'Hui', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Pokfulam Road, Hong Kong SAR, Hong Kong.'}, {'ForeName': 'Christy Yim-Fan', 'Initials': 'CY', 'LastName': 'Wong', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Pokfulam Road, Hong Kong SAR, Hong Kong.'}, {'ForeName': 'Eric Ka-Yiu', 'Initials': 'EK', 'LastName': 'Ma', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Pokfulam Road, Hong Kong SAR, Hong Kong.'}, {'ForeName': 'Fiona Yan-Yee', 'Initials': 'FY', 'LastName': 'Ho', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Chan', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Pokfulam Road, Hong Kong SAR, Hong Kong. shaunlyn@hku.hk.'}]",Trials,['10.1186/s13063-020-04778-1']
2029,32769414,High-frequency 10 kHz Spinal Cord Stimulation for Chronic Back and Leg Pain: Cost-consequence and Cost-effectiveness Analyses.,"OBJECTIVES


There is good evidence that spinal cord stimulation (SCS) is effective for reducing chronic back and leg pain (CBLP). SENZA randomized controlled trial showed high-frequency (10 kHz) stimulation (10 kHz-SCS) is clinically superior to traditional low-frequency SCS (LF-SCS).Undertake cost-consequence and cost-effectiveness analysis of 10 kHz-SCS compared with LF-SCS.
METHODS


A probabilistic decision tree and Markov decision analytic model was used to synthesize data on CBLP outcomes and costs over a 15-year time horizon from a UK National Health Service perspective using data from the SENZA randomized controlled trial and other publications. Results are expressed as incremental cost per quality-adjusted life year (QALY) in 2016 Pounds Sterling.
RESULTS


10 kHz-SCS is cost-saving and cost-effective compared with LF-SCS, with mean cost-savings of £7170 (95% confidence interval: £6767-£7573) and £3552 (95% confidence interval: £3313-£3792) per patient compared with nonrechargeable and rechargeable LF-SCS devices, respectively. 10 kHz-SCS has a 95% likelihood of being cost-effective at a willingness-to-pay threshold of £20,000 per QALY. Our findings were robust across a wide range of sensitivity analyses.
CONCLUSIONS


There is a strong economic case for choosing 10 kHz-SCS over LF-SCS for CBLP. Furthermore, 10 kHz-SCS has clinical advantages not captured in our analysis, including shorter, and more predictable procedure times.",2020,"SENZA randomized controlled trial showed high-frequency (10 kHz) stimulation (10 kHz-SCS) is clinically superior to traditional low-frequency SCS (LF-SCS).Undertake cost-consequence and cost-effectiveness analysis of 10 kHz-SCS compared with LF-SCS.
",[],"['frequency (10\u2009kHz) stimulation (10\u2009kHz-SCS', 'spinal cord stimulation (SCS', 'High-frequency 10\u2009kHz Spinal Cord Stimulation']","['cost-saving and cost-effective', 'chronic back and leg pain (CBLP', 'mean cost-savings']",[],"[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0556965', 'cui_str': 'kHz'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]","[{'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.145027,"SENZA randomized controlled trial showed high-frequency (10 kHz) stimulation (10 kHz-SCS) is clinically superior to traditional low-frequency SCS (LF-SCS).Undertake cost-consequence and cost-effectiveness analysis of 10 kHz-SCS compared with LF-SCS.
","[{'ForeName': 'Rod S', 'Initials': 'RS', 'LastName': 'Taylor', 'Affiliation': 'Institute of Health and Well Being, University of Glasgow, Glasgow.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Bentley', 'Affiliation': 'Mtech Access Limited, Bicester, Oxfordshire, UK.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Campbell', 'Affiliation': 'University of Exeter Medical School, Exeter.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Murphy', 'Affiliation': 'Nevro Corporation, Redwood City, CA.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000866']
2030,33019480,Extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection for treating early-stage Femur Head Necrosis: Protocol for a randomized controlled trial.,"BACKGROUND


Early diagnosis and treatment of the osteonecrosis of the femoral head (ONFH), a refractory disease, is imperative to prevent femoral head collapse; however, the existing solutions remain controversial. This study assessed the safety and efficacy of extracorporeal shock wave therapy (ESWT) combined with multiple drilling and intramedullary drug injection, a novel cocktail therapy, as a randomized controlled trial (RCT) model to postulate an alternative therapy for patients with early-stage ONFH.
METHODS


Femoral head necrosis patients aged 20 to 60 years with stage ARCO I-II were recruited. One hundred twenty eligible participants were randomized into four groups in a 1:1:1:1 ratio: extracorporeal shock wave therapy combined with multiple drilling and intramedullary drug injection (group EMI), extracorporeal shock wave therapy (group E), multiple drilling combined with intramedullary drug injection (group MI), and multiple drilling (""positive"" control group; group M). The primary outcomes included effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema. Secondary outcomes included the Harris Hip Score and the visual analog scale. All outcomes were measured at the screening visit (baseline) and at the planned time intervals during treatment and follow-up, and the efficacy was statistically analyzed according to the intention-to-treat sub-populations and per-protocol sub-populations.
OBJECTIVES


To examine the clinical efficacy of ESWT combined with multiple drilling and intramedullary drug injection to provide a safe and more effective method for treating early-stage ONFH.
TRIAL REGISTRATION NUMBER


ChiCTR1900020888; Pre-results.",2020,"The primary outcomes included effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema.","['patients with early-stage ONFH', 'One hundred twenty eligible participants', 'Femoral head necrosis patients aged 20 to 60 years with stage ARCO I-II were recruited']","['extracorporeal shock wave therapy (ESWT) combined with multiple drilling and intramedullary drug injection', 'Extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection', 'extracorporeal shock wave therapy combined with multiple drilling and intramedullary drug injection (group EMI), extracorporeal shock wave therapy (group E), multiple drilling combined with intramedullary drug injection (group MI), and multiple drilling (""positive"" control group; group M', 'ESWT combined with multiple drilling and intramedullary drug injection']","['Harris Hip Score and the visual analog scale', 'effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C2743413', 'cui_str': 'ARCO'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0337279', 'cui_str': 'Drilling - action'}, {'cui': 'C1512957', 'cui_str': 'Intramedullary route'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441839', 'cui_str': 'Group E'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441847', 'cui_str': 'Group M'}]","[{'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0948162', 'cui_str': 'Edema of bone marrow'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",120.0,0.140282,"The primary outcomes included effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema.","[{'ForeName': 'Qianchun', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'School of Clinical Medicine, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Rigao', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Xinling', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Xueya', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Anorectal Surgery, Nanchong Central Hospital, Nanchong.'}, {'ForeName': 'Leiming', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Botao', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Xin', 'Affiliation': 'Department of Intensive Care Unit, JianGe County Hospital of Traditional Chinese Medicine, Guangyuan, Sichuan, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Jian', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Zhongchao', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}]",Medicine,['10.1097/MD.0000000000022598']
2031,33017428,Mortality rate-dependent variations in antenatal corticosteroid-associated outcomes in very low birth weight infants with 23-34 weeks of gestation: A nationwide cohort study.,"Antenatal corticosteroid (ACS) administration has been known as one of the most effective treatment in perinatal medicine, but the beneficial effects of ACS may vary not only gestational age, but also the quality of perinatal and neonatal care of the institution. This nationwide cohort study of the Korean Neonatal Network (KNN) data was consisted of <1,500g infants born at 23-34 weeks at 67 KNN hospitals between 2013 and 2017. The 9,142 eligible infants were assigned into two groups-group 1 and 2 <50% and ≥50% mortality rate, respectively, for 23-24 weeks' gestation-reflecting the quality of perinatal and neonatal care. Each group of infants were further stratified into 23-24, 25-26, 27-28, and 29-34 weeks of gestation age. Despite comparable ACS usage between group 1 (82%) and group 2 (81%), the benefits of ACS were only observed in group 1. In the multivariable analyses, infants of group 1 showed significant decrease in mortality and IVH at gestational age 23-24 weeks with ACS use, and the decrease was also seen in early-onset sepsis and respiratory distress syndrome at gestational age of 29-34 weeks while there were no significant decrease in group 2. In this study the overall data was congruent with the previous findings stating that ACS use decreases mortality and morbidity. These results indicate that the improved mortality of infants at 23-24 weeks' gestation reflects the quality improvement of perinatal and neonatal intensive care, which is a prerequisite to the benefits of ACS.",2020,"In the multivariable analyses, infants of group 1 showed significant decrease in mortality and IVH at gestational age 23-24 weeks with ACS use, and the decrease was also seen in early-onset sepsis and respiratory distress syndrome at gestational age of 29-34 weeks while there were no significant decrease in group 2.","['9,142 eligible infants', 'Korean Neonatal Network (KNN) data was consisted of <1,500g infants born at 23-34 weeks at 67 KNN hospitals between 2013 and 2017', 'very low birth weight infants with 23-34 weeks of gestation']",['Antenatal corticosteroid (ACS'],"['Mortality rate', 'benefits of ACS', 'early-onset sepsis and respiratory distress syndrome', 'mortality and IVH', 'mortality and morbidity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",9142.0,0.0542073,"In the multivariable analyses, infants of group 1 showed significant decrease in mortality and IVH at gestational age 23-24 weeks with ACS use, and the decrease was also seen in early-onset sepsis and respiratory distress syndrome at gestational age of 29-34 weeks while there were no significant decrease in group 2.","[{'ForeName': 'Jin Kyu', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'Department of Pediatrics, Jeonbuk National University School of Medicine, Jeonju, Korea.'}, {'ForeName': 'Jong Hee', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': 'Department of Pediatrics, Ilsan Paik Hospital, InJe University College of Medicine, Goyang, Korea.'}, {'ForeName': 'Myung Hee', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Statistic and Data Center, Samsung Medical Center, Seoul, Korea.'}, {'ForeName': 'Yun Sil', 'Initials': 'YS', 'LastName': 'Chang', 'Affiliation': 'Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Won Soon', 'Initials': 'WS', 'LastName': 'Park', 'Affiliation': 'Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0240168']
2032,33017434,Whole-body protein kinetics in critically ill patients during 50 or 100% energy provision by enteral nutrition: A randomized cross-over study.,"BACKGROUND


Enteral nutrition (EN) is a ubiquitous intervention in ICU patients but there is uncertainty regarding the optimal dose, timing and importance for patient-centered outcomes during critical illness. Our research group has previously found an improved protein balance during normocaloric versus hypocaloric parenteral nutrition in neurosurgical ICU patients. We now wanted to investigate if this could be demonstrated in a general ICU population with established enteral feeding, including patients on renal replacement therapy.
METHODS


Patients with EN >80% of energy target as determined by indirect calorimetry were randomized to or 50% or 100% of current EN rate. After 24 hours, whole-body protein kinetics were determined by enteral and parenteral stable isotope tracer infusions. Treatment allocation was then switched, and tracer investigations repeated 24 hours later in a crossover design with patients serving as their own controls.
RESULTS


Six patients completed the full protocol. During feeding with 100% EN all patients received >1.2 g/kg/day of protein. Mean whole-body protein balance increased from -6.07 to 2.93 µmol phenylalanine/kg/h during 100% EN as compared to 50% (p = 0.044). The oxidation rate of phenylalanine was unaltered (p = 0.78).
CONCLUSIONS


It is possible to assess whole-body protein turnover using a stable isotope technique in critically ill patients during enteral feeding and renal replacement therapy. Our results also suggest a better whole-body protein balance during full dose as compared to half dose EN. As the sample size was smaller than anticipated, this finding should be confirmed in larger studies.",2020,Mean whole-body protein balance increased from -6.07 to 2.93 µmol phenylalanine/kg/h during 100% EN as compared to 50% (p = 0.044).,"['neurosurgical ICU patients', 'ICU patients', 'Patients with EN >80% of energy target as determined by indirect calorimetry', 'general ICU population with established enteral feeding, including patients on renal replacement therapy', 'critically ill patients during enteral feeding and renal replacement therapy', 'critically ill patients during 50 or 100% energy provision by enteral nutrition']",['Enteral nutrition (EN'],"['Mean whole-body protein balance', 'protein balance', 'oxidation rate of phenylalanine']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}]",,0.0217836,Mean whole-body protein balance increased from -6.07 to 2.93 µmol phenylalanine/kg/h during 100% EN as compared to 50% (p = 0.044).,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sundström Rehal', 'Affiliation': 'Department of Perioperative Medicine and Intensive Care (PMI), Karolinska University Hospital Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Liebau', 'Affiliation': 'Department of Perioperative Medicine and Intensive Care (PMI), Karolinska University Hospital Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wernerman', 'Affiliation': 'Division of Anesthesia and Intensive Care, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Rooyackers', 'Affiliation': 'Department of Perioperative Medicine and Intensive Care (PMI), Karolinska University Hospital Huddinge, Stockholm, Sweden.'}]",PloS one,['10.1371/journal.pone.0240045']
2033,33017450,Origami folding: Taxing resources necessary for the acquisition of sequential skills.,"Sequential skill learning with practice is fundamental to human activity (e.g., tying shoes). Given the lack of prior knowledge in most participants, Origami folding is a promising task to study the acquisition of a sequential skill. While previous Origami folding studies mainly dealt with the question, which forms of instruction can lead to better learning outcomes, we employ a dual-task approach to test which resources are necessary for folding and for improvement with practice. Participants (N = 53) folded five Origami figures for four times each, which were randomly paired with five types of secondary tasks to cause either cognitive (verbal vs. visuospatial) or motoric (isochronous vs. non-isochronous tapping) memory load or none (control condition). Origami performance showed a typical learning curve from Trial 1 (first run of folding the figure) to Trial 4 (fourth run of folding the same figure). We tested for a dissociation between variants of memory load influencing Origami folding performance vs. the variants influencing learning (i.e. change in performance across practice). In line with theories suggesting that learning operates on the level that (at a given point in practice) demands the most control, we did not observe cases where a dual-task variant influenced performance while it did not affect learning. Memory load from the cognitive visuospatial secondary task as well as the isochronous tapping secondary task interfered with improvement in Origami folding with practice. This might be due to the use of visuospatial sketchpad and absolute timing mechanism during the acquisition of Origami folding.",2020,Memory load from the cognitive visuospatial secondary task as well as the isochronous tapping secondary task interfered with improvement in Origami folding with practice.,[],['secondary tasks to cause either cognitive (verbal vs. visuospatial) or motoric (isochronous vs. non-isochronous tapping) memory load or none (control condition'],['Origami performance'],[],"[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],53.0,0.0243564,Memory load from the cognitive visuospatial secondary task as well as the isochronous tapping secondary task interfered with improvement in Origami folding with practice.,"[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Department of Psychology, University of Hagen, Hagen, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gaschler', 'Affiliation': 'Department of Psychology, University of Hagen, Hagen, Germany.'}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Kneschke', 'Affiliation': 'Department of Psychology, University of Hagen, Hagen, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Radler', 'Affiliation': 'Department of Psychology, University of Hagen, Hagen, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Gausmann', 'Affiliation': 'Department of Psychology, University of Hagen, Hagen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Duttine', 'Affiliation': 'Department of Psychology, University of Hagen, Hagen, Germany.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Haider', 'Affiliation': 'Department of Psychology, University of Cologne, Cologne, Germany.'}]",PloS one,['10.1371/journal.pone.0240226']
2034,33022483,The Norwegian healthy body image intervention promotes positive embodiment through improved self-esteem.,"We examined both direct and indirect effects of the Healthy Body Image (HBI) intervention on positive embodiment among Norwegian high school students. In total, 2446 12th grade boys (43 %) and girls (mean age 16.8 years) from 30 schools participated in a cluster-randomized controlled study with the HBI intervention and a control condition as the study arms. We tested mediation models using path analysis and found that among several hypothesized mediators, only self-esteem mediated a positive intervention effect on positive embodiment for both boys and girls. A direct effect of the intervention on positive embodiment was only found in girls. The study provides novel findings indicating that health promotion interventions to address a positive embodiment should focus on enhancing adolescent's self-esteem. Serial mediation modeling might reveal more complex explanations of change mechanisms and could further evolve current knowledge.",2020,We examined both direct and indirect effects of the Healthy Body Image (HBI) intervention on positive embodiment among Norwegian high school students.,"['girls', 'Norwegian high school students', '2446 12th grade boys (43 %) and girls (mean age 16.8 years) from 30 schools participated in a cluster-randomized controlled study with the']","['HBI intervention', 'Healthy Body Image (HBI) intervention']",['positive embodiment'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517591', 'cui_str': '16.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0192935,We examined both direct and indirect effects of the Healthy Body Image (HBI) intervention on positive embodiment among Norwegian high school students.,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Sundgot-Borgen', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: chrsun@ous-hf.no.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stenling', 'Affiliation': 'Umeå University, Department of Psychology, 901 87 Umeå, Sweden. Electronic address: andreas.stenling@umu.se.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Rosenvinge', 'Affiliation': 'UiT -The Arctic University of Norway, Faculty of Health Sciences Department of Psychology, 9037 Tromsø, Norway. Electronic address: jan.rosenvinge@uit.no.'}, {'ForeName': 'Gunn', 'Initials': 'G', 'LastName': 'Pettersen', 'Affiliation': 'UiT -The Arctic University of Norway, Faculty of Health Sciences Department of Health and Caring Sciences, N- 9037 Tromsø, Norway. Electronic address: gunn.pettersen@uit.no.'}, {'ForeName': 'Oddgeir', 'Initials': 'O', 'LastName': 'Friborg', 'Affiliation': 'UiT -The Arctic University of Norway, Faculty of Health Sciences Department of Psychology, 9037 Tromsø, Norway. Electronic address: oddgeir.friborg@uit.no.'}, {'ForeName': 'Jorunn', 'Initials': 'J', 'LastName': 'Sundgot-Borgen', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: jorunn.sundgot-borgen@nih.no.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Kolle', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: elin.kolle@nih.no.'}, {'ForeName': 'Monica Klungland', 'Initials': 'MK', 'LastName': 'Torstveit', 'Affiliation': 'University of Agder, Faculty of Health and Sport Sciences, Postbox 422, 4604 Kristiansand, Norway. Electronic address: monica.k.torstveit@uia.no.'}, {'ForeName': 'Kethe M E', 'Initials': 'KME', 'LastName': 'Svantorp-Tveiten', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: k.m.e.engen@nih.no.'}, {'ForeName': 'Solfrid', 'Initials': 'S', 'LastName': 'Bratland-Sanda', 'Affiliation': 'University College of Southeast Norway, Department of Sports, Physical Education and Outdoor Studies, P.O. Box 235, N-3603 Kongsberg, Norway. Electronic address: Solfrid.Bratland-Sanda@usn.no.'}]",Body image,['10.1016/j.bodyim.2020.08.014']
2035,32484870,Which Method of Assessing Depression and Anxiety Best Predicts Smoking Cessation: Screening Instruments or Self-Reported Conditions?,"INTRODUCTION


Affective disorders and symptoms (ADS) are predictive of lower odds of quitting smoking. However, it is unknown which approach to assessing ADS best predicts cessation. This study compared a battery of ADS screening instruments with a single, self-report question on predicting cessation. Among those who self-reported ADS, we also examined if an additional question regarding whether participants believed the condition(s) might interfere with their ability to quit added predictive utility to the single-item question.
METHODS


Participants (N = 2637) enrolled in a randomized controlled trial of web-based smoking treatments completed a battery of five ADS screening instruments and answered a single-item question about having ADS. Those with a positive self-report on the single-item question were also asked about their interference beliefs. The primary outcome was complete-case, self-reported 30-day point prevalence abstinence at 12 months.
RESULTS


Both assessment approaches significantly predicted cessation. Screening positive for ≥ one ADS in the battery was associated with 23% lower odds of quitting than not screening positive for any (p = .023); those with a positive self-report on the single-item had 39% lower odds of quitting than self-reporting no mental health conditions (p < .001). Area under the receiver operating characteristic curve values for the two assessment approaches were similar (p = .136). Adding the interference belief question to the single-item assessment significantly increased the area under the receiver operating characteristic curve value (p = .042).
CONCLUSIONS


The single-item question assessing ADS had as much predictive validity, and possibly more, than the battery of screening instruments for identifying participants at risk for failing to quit smoking. Adding a question about interference beliefs significantly increased the predictive utility of the single-item question.
IMPLICATIONS


This is the first study to demonstrate that a single-item question assessing ADS has at least as much predictive validity, and possibly more, than a battery of validated screening instruments for identifying smokers at highest risk for cessation failure. This study also demonstrates adding a question about interference beliefs significantly adds to the predictive utility of a single, self-report question about mental health conditions. Findings from this study can be used to inform decisions regarding how to assess ADS in the context of tobacco treatment settings.",2020,Screening positive for ≥ one ADS in the battery was associated with 23% lower odds of quitting than not screening positive for any (p = .023); those with a positive self-report on the single-item had 39% lower odds of quitting than self-reporting no mental health conditions (p < .001).,['Participants (N = 2637) enrolled in a randomized controlled trial of web-based smoking treatments completed a battery of five ADS screening instruments and answered a single-item question about having ADS'],[],"['Depression and Anxiety Best Predicts Smoking Cessation', 'complete-case, self-reported 30-day point prevalence abstinence']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]",[],"[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",2637.0,0.0463385,Screening positive for ≥ one ADS in the battery was associated with 23% lower odds of quitting than not screening positive for any (p = .023); those with a positive self-report on the single-item had 39% lower odds of quitting than self-reporting no mental health conditions (p < .001).,"[{'ForeName': 'Noreen L', 'Initials': 'NL', 'LastName': 'Watson', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Jaimee L', 'Initials': 'JL', 'LastName': 'Heffner', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'Mull', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'McClure', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Bricker', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa099']
2036,33030582,Efficacy and safety of oral magnesium supplementation in reducing febrile neutropenia episodes in children with solid tumors treated with cisplatin-based chemotherapy: randomized clinical trial.,"PURPOSE


Hypomagnesemia has been associated with febrile neutropenia (FN) in pediatric patients receiving cisplatin-based chemotherapy (CDDPBC). The primary aim was to determine whether oral magnesium supplementation reduces FN episodes in pediatric patients with solid tumors treated with CDDPBC.
METHOD


This randomized clinical trial, with open-label, single-center, parallel group and superiority design was conducted in Hospital Infantil de Mexico Federico Gomez at Mexico City. Children ≥ 9 years with solid tumors that were to receive a CDDPBC cycle were invited to participate. Each chemotherapy cycle with CDDPBC was randomly assigned to receive oral magnesium supplementation (250 mg/day) or not receive magnesium supplementation (control group). Efficacy was determined by relative risks (RR) with 95% confidence intervals (95% CI) as well as with numbers needed to treat (NNT). Active surveillance was conducted to assess safety in both groups. Analyses were carried out by intention to treat. ClinicalTrials.gov number NCT03449693.
RESULTS


One hundred and one chemotherapy cycles with CDDPBC were analyzed (50 in the magnesium supplement arm and 51 in control group). Baseline clinical characteristics were similar comparing both groups. Oral magnesium supplementation reduces FN episodes compared to control group [RR 0.53, (95% CI 0.32-0.89), NNT = 4]. In the supplemented group, patients had fewer episodes of septic shock secondary to FN [RR 0.43, (95% CI 0.02-0.94), NNT = 6] and FN appeared on average 5 days later (p = 0.031). Hypomagnesemia episodes and adverse events were similar across both groups.
CONCLUSION


Oral supplementation with magnesium reduces FN episodes neutropenia in pediatric patients with solid tumors treated with CDDPBC.",2020,"Oral magnesium supplementation reduces FN episodes compared to control group [RR 0.53, (95% CI 0.32-0.89), NNT = 4].","['9\xa0years with solid tumors that were to receive a CDDPBC cycle were invited to participate', 'Children\u2009≥', 'pediatric patients receiving', 'children with solid tumors treated with', 'pediatric patients with solid tumors treated with CDDPBC']","['magnesium', 'cisplatin-based chemotherapy', 'cisplatin-based chemotherapy (CDDPBC', 'oral magnesium supplementation', 'magnesium supplementation (control group', 'Oral magnesium supplementation']","['FN episodes', 'FN episodes neutropenia', 'Efficacy and safety', 'Efficacy', 'episodes of septic shock secondary to FN', 'Hypomagnesemia episodes and adverse events', 'febrile neutropenia episodes']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1096534', 'cui_str': 'Magnesium supplement therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.387148,"Oral magnesium supplementation reduces FN episodes compared to control group [RR 0.53, (95% CI 0.32-0.89), NNT = 4].","[{'ForeName': 'Osvaldo D', 'Initials': 'OD', 'LastName': 'Castelán-Martínez', 'Affiliation': 'Clinical Pharmacology Laboratory, UMIEZ, Facultad de Estudios Superiores Zaragoza, UNAM, Batalla 5 de mayo s/n esquina Fuerte de Loreto, Col. Ejército de Oriente, Iztapalapa, CP 09230, Mexico City, Mexico. castelan@unam.mx.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Palomo-Colli', 'Affiliation': 'Onco-Hematology Department, Hospital Infantil de México Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Barrios-López', 'Affiliation': 'Onco-Hematology Department, Hospital Infantil de México Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'Karla M', 'Initials': 'KM', 'LastName': 'Silva-Jivaja', 'Affiliation': 'Clinical Pharmacology Laboratory, UMIEZ, Facultad de Estudios Superiores Zaragoza, UNAM, Batalla 5 de mayo s/n esquina Fuerte de Loreto, Col. Ejército de Oriente, Iztapalapa, CP 09230, Mexico City, Mexico.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Juárez-Villegas', 'Affiliation': 'Onco-Hematology Department, Hospital Infantil de México Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Castañeda-Hernández', 'Affiliation': 'Pharmacology Department, Centro de Investigación y Estudios Avanzados del Instituto Politécnico Nacional, Mexico City, Mexico.'}, {'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Sánchez-Rodríguez', 'Affiliation': 'Research Uniton Gerontology, Facultad de Estudios Superiores Zaragoza, UNAM, Mexico City, Mexico.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04155-4']
2037,33027708,Delivery room skin-to-skin contact in preterm infants affects long-term expression of stress response genes.,"Premature birth is a traumatic event that puts mother and child at risk for subsequent psychopathology. Skin-to-skin contact in the form of intermittent kangaroo mother care has been shown to positively affect the infant's stress response and cognitive development, but underlying mechanisms remain unclear. Moreover, first skin-to-skin contact is usually delayed for days after birth. In the delivery room skin-to-skin study (DR-SSC), a prospective randomized controlled trial conducted from 2/2012 to 7/2015, we set out to assess the effect of delivery room skin-to-skin contact on the infant's mRNA expression of six key molecules involved in stress response and neurobehavioral development at hospital discharge. 88 firstborn, singleton preterm infants (born at 25-32 weeks of gestational age) were included. In the delivery room after initial stabilization, infants were randomized to either 60 min of skin-to-skin or 5 min of visual contact with their mother. In this explorative add-on study on the original DR-SSC study, we determined the expression of six important stress response genes (CRHR1 and CRHR2, AVP, NR3C1, HTR2A, and SLC6A4) in peripheral white blood cells of infants during routine blood sampling upon hospital discharge (corrected gestational age of 40 weeks). Infants were followed up to six months corrected age. Relative mRNA expression of the corticotropin releasing hormone receptor 2 (CRH R2), the glucocorticoid receptor gene (NR3C1), and the serotonin transporter gene (SLC6A4) was significantly reduced in the delivery room SSC infants. Additionally, gene expression of CRH R2 showed a correlation with HPA axis reactivity and parameters of mother-child interaction at six months corrected age. Our results highlight the importance of delivery room mother-child skin-to-skin contact and underline the urgent need for in-depth studies on the underlying molecular mechanisms.",2020,"Additionally, gene expression of CRH R2 showed a correlation with HPA axis reactivity and parameters of mother-child interaction at six months corrected age.","['peripheral white blood cells of infants during routine blood sampling upon hospital discharge (corrected gestational age of 40 weeks', 'preterm infants', '88 firstborn, singleton preterm infants (born at 25-32 weeks of gestational age']","['delivery room skin-to-skin contact', '60 min of skin-to-skin or 5 min of visual contact with their mother']","['HPA axis reactivity and parameters of mother-child interaction', 'expression of six important stress response genes (CRHR1 and CRHR2, AVP, NR3C1, HTR2A, and SLC6A4']","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C0011212', 'cui_str': 'Delivery suite'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0085355', 'cui_str': 'Platelet-specific antigen'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026590', 'cui_str': 'Mother-Child Relationship'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0078039', 'cui_str': 'VAP combination'}, {'cui': 'C1370369', 'cui_str': 'NR3C1 protein, human'}, {'cui': 'C1456457', 'cui_str': 'SLC6A4 protein, human'}]",,0.0170859,"Additionally, gene expression of CRH R2 showed a correlation with HPA axis reactivity and parameters of mother-child interaction at six months corrected age.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hucklenbruch-Rother', 'Affiliation': ""Metabolism and Perinatal Programming, Children's Hospital, University of Cologne, Cologne, Germany. Electronic address: eva.rother@uni-koeln.de.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Vohlen', 'Affiliation': ""Metabolism and Perinatal Programming, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Mehdiani', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Titus', 'Initials': 'T', 'LastName': 'Keller', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Roth', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Kribs', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Mehler', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104883']
2038,33027722,Hysteroscopic versus cervical injection for sentinel node detection in endometrial cancer: A multicenter prospective randomised controlled trial from the Multicenter Italian Trials in Ovarian cancer (MITO) study group.,"AIM


During the last years, the role of sentinel lymph node mapping (SLNM) for endometrial cancer (EC) surgical treatment has increased in popularity. However, several controversies remain about different technical steps of SLNM. Thus, a randomised control trial was designed to compare cervical (CI) and hysteroscopic (HI) indocyanine green (ICG) injection for SLNM of newly diagnosed EC undergoing surgical staging. The primary end-point of the study was to compare these two techniques in terms of para-aortic detection rate.
METHODS


Patients with apparent stage I or II histologically confirmed EC undergoing surgery were included in the study. This randomised trial distinguished patients in two study groups according to two different techniques of ICG SLNM: CI versus HI injection. Patients who met the inclusion criteria were randomly assigned to CI or HI injection in a 1:1 ratio. The central randomisation system allocated patient randomisation numbers sequentially in the order in which the patients were enrolled. This randomised trial was not blinded for either patients or the surgeons.
RESULTS


From March 2017 until April 2019, a total of 165 patients were randomised in this study: 85 (51.5%) in the CI group and 80 (48.5%) in the HI group. After randomisation, 14 (8.5%) patients were excluded from the study. Finally, 151 patients were included in the analysis: 82 (54.3%) in the CI group and 69 (45.7%) in the HI group. Hysteroscopy injection shows an ability to detect Sentinel nodes (SNLs) in the para-aortic area of about 10% greater compared with CI injection, although this difference did not reach statistical significance. The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%). The CI injection was correlated with higher SLN detection rates at the pelvic level compared with HI injection. Pelvic and overall detection was higher in the CI group.
CONCLUSIONS


The present study supports the adoption of CI instead of HI injection because the former allows better identification of sentinel nodes (especially in the pelvic area). Detection of SLN in the para-aortic area was slightly higher in patients receiving a HI injection, but the difference with the CI route was not statistically significant.",2020,The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%).,"['151 patients were included in the analysis: 82 (54.3%) in the CI group and 69 (45.7%) in the HI group', '165 patients', 'Patients who met the inclusion criteria', 'patients or the surgeons', 'From March 2017 until April 2019', 'Patients with apparent stage I or II histologically confirmed EC undergoing surgery were included in the study', 'endometrial cancer', 'newly diagnosed EC undergoing surgical staging']","['cervical (CI) and hysteroscopic (HI) indocyanine green (ICG) injection', 'sentinel lymph node mapping (SLNM', 'Hysteroscopic versus cervical injection', 'ICG\xa0SLNM: CI versus HI injection', 'CI or HI injection', 'Hysteroscopy injection']","['para-aortic detection rate', 'SLN detection rates', 'Pelvic and overall detection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443276', 'cui_str': 'Pathological staging'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1519247', 'cui_str': 'Sentinel lymph node mapping'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]","[{'cui': 'C0442134', 'cui_str': 'Para-aortic'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",165.0,0.181524,The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%).,"[{'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Ditto', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy. Electronic address: antonino.ditto@istitutotumori.mi.it.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Casarin', 'Affiliation': 'Academic Unit of Obstetrics and Gynaecology, Insubria University of Varese, Varese, Italy.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Perrone', 'Affiliation': ""Unit Gynaecologic Oncology, Sant'Orsola Malpighi of Bologna, Bologna, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Scollo', 'Affiliation': 'Unit of Obstetrics and Gynaecology, Cannizzaro Hospital of Catania, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Martinelli', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Bogani', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Umberto L R', 'Initials': 'ULR', 'LastName': 'Maggiore', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Signorelli', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Chiappa', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Giorda', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS CRO Oncologic Institute of Aviano, Aviano, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Scibilia', 'Affiliation': 'Unit of Obstetrics and Gynaecology, Cannizzaro Hospital of Catania, Italy.'}, {'ForeName': 'Pierandrea', 'Initials': 'P', 'LastName': 'De Iaco', 'Affiliation': ""Unit Gynaecologic Oncology, Sant'Orsola Malpighi of Bologna, Bologna, Italy.""}, {'ForeName': 'Mariateresa', 'Initials': 'M', 'LastName': 'Evangelista', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ghezzi', 'Affiliation': 'Academic Unit of Obstetrics and Gynaecology, Insubria University of Varese, Varese, Italy.'}, {'ForeName': 'Biagio', 'Initials': 'B', 'LastName': 'Paolini', 'Affiliation': 'Department of Pathology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Lo Vullo', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy; Unit of Clinical Epidemiology and Trial Organization, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Mariani', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy; Unit of Clinical Epidemiology and Trial Organization, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Montone', 'Affiliation': 'Clinical Study Coordinator, Ufficio Operativo per la Ricerca Clinica - Clinical Trial Center Fondazione IRCCS Istituto Nazionale dei Tumori, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Raspagliesi', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.08.030']
2039,33027748,Renal protection with glucagon-like peptide-1 receptor agonists.,"There is an unmet need for renoprotective drugs for more pronounced reduction of albuminuria beyond that provided by renin-angiotensin system (RAS) blockers and for effective slowdown of eGFR decline independent of albuminuria. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have proven effective in reducing prespecified secondary composite kidney outcomes in cardiovascular outcome trials. However, GLP-1 RAs showed a prevailing anti-albuminuric effect, additional to that of RAS blockers, and a non-significant risk reduction in worsening of kidney function, at variance with sodium-glucose cotransporter 2 inhibitors. Mechanisms underlying renal protection with GLP-1 RAs are porly understood. Though treatment with GLP-1 RAs resulted in better glycaemic, blood pressure and body weight control versus placebo, correction for on-trial changes in these parameters did not significantly affect results. Anti-inflammatory/anti-oxidant effects via intracellular signalling through protein kinase A, natriuretic effect via inhibition of sodium-hydrogen exchanger 3 and reduction of hyperfiltration have been proposed as direct renoprotective effects.",2020,"Though treatment with GLP-1 RAs resulted in better glycaemic, blood pressure and body weight control versus placebo, correction for on-trial changes in these parameters did not significantly affect results.",[],"['Glucagon-like peptide-1 receptor agonists (GLP-1 RAs', 'GLP-1 RAs', 'glucagon-like peptide-1 receptor agonists']","['glycaemic, blood pressure and body weight control']",[],"[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0545075,"Though treatment with GLP-1 RAs resulted in better glycaemic, blood pressure and body weight control versus placebo, correction for on-trial changes in these parameters did not significantly affect results.","[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Department of Clinical and Molecular Medicine, ""La Sapienza"" University, and Endocrine and Metabolic Unit, Sant\'Andrea University Hospital, Rome, Italy.'}, {'ForeName': 'Jonida', 'Initials': 'J', 'LastName': 'Haxhi', 'Affiliation': 'Department of Clinical and Molecular Medicine, ""La Sapienza"" University, and Endocrine and Metabolic Unit, Sant\'Andrea University Hospital, Rome, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Cirrito', 'Affiliation': 'Department of Clinical and Molecular Medicine, ""La Sapienza"" University, and Endocrine and Metabolic Unit, Sant\'Andrea University Hospital, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pugliese', 'Affiliation': 'Department of Clinical and Molecular Medicine, ""La Sapienza"" University, and Endocrine and Metabolic Unit, Sant\'Andrea University Hospital, Rome, Italy. Electronic address: giuseppe.pugliese@uniroma1.it.'}]",Current opinion in pharmacology,['10.1016/j.coph.2020.08.018']
2040,33032532,A physical activity program versus usual care in the management of quality of life for pre-frail older adults with chronic pain: randomized controlled trial.,"BACKGROUND


Exercise has shown being effective for managing chronic pain and preventing frailty status in older adults but the effect of an exercise program in the quality of life of pre-frail older adults with chronic pain remains unclear. Our objective was to evaluate the effectiveness of multicomponent structured physical exercise program for pre-frail adults aged 65 years or more with chronic pain to improve their perceived health related quality of life, compared with usual care.
METHODS


Open label randomized controlled trial. Participants were community-dwelling pre-frail older adults aged 65 years or older with chronic pain and non-dependent for basic activities of daily living attending a Primary Healthcare Centre. Forty-four participants were randomly allocated to a control group (n = 20) that received usual care or an intervention group (n = 24) that received an 8-week physical activity and education program. Frailty status (SHARE Frailty Index), quality of life (EuroQol-5D-5L), pain intensity (Visual Analogue Scale), physical performance (Short Physical Performance Battery) and depression (Yessavage) were assessed at baseline, after the intervention and after 3 months follow-up. The effect of the intervention was analysed by mean differences between the intervention and control groups.
RESULTS


The follow-up period (3 months) was completed by 32 patients (73%), 17 in the control group and 15 in the intervention group. Most participants were women (78.1%) with a mean age (standard deviation) of 77.2 (5.9) years and a mean pain intensity of 48.1 (24.4) mm. No relevant differences were found between groups at baseline. After the intervention, mean differences in the EuroQol Index Value between control and intervention groups were significant (- 0.19 95% CI(- 0.33- -0.04)) and remained after 3 months follow-up (- 0.21 95% CI(- 0.37- -0.05)). Participants in the exercise group showed better results in pain intensity and frailty after the intervention, and an improvement in physical performance after the intervention and after 3 months.
CONCLUSIONS


An eight-week physical activity and education program for pre-frail older adults with chronic pain, compared with usual care, could be effective to improve quality of life after the intervention and after three-months follow-up.
STUDY REGISTRATION DETAILS


This study was retrospectively registered in ClinicalTrials.gov with the identifier NCT04045535 .",2020,"Participants in the exercise group showed better results in pain intensity and frailty after the intervention, and an improvement in physical performance after the intervention and after 3 months.
","['older adults', 'Most participants were women (78.1%) with a mean age (standard deviation) of 77.2 (5.9) years and a mean pain intensity of 48.1 (24.4) mm', 'pre-frail adults aged 65\u2009years or more with chronic pain', 'Participants were community-dwelling pre-frail older adults aged 65\u2009years or older with chronic pain and non-dependent for basic activities of daily living attending a Primary Healthcare Centre', 'Forty-four participants', 'pre-frail older adults with chronic pain']","['control group (n\u2009=\u200920) that received usual care or an intervention group (n\u2009=\u200924) that received an 8-week physical activity and education program', 'multicomponent structured physical exercise program', 'physical activity program versus usual care', 'exercise program']","['EuroQol Index Value', 'Frailty status (SHARE Frailty Index), quality of life (EuroQol-5D-5L), pain intensity (Visual Analogue Scale), physical performance (Short Physical Performance Battery) and depression (Yessavage', 'pain intensity and frailty', 'physical performance', 'quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",44.0,0.128245,"Participants in the exercise group showed better results in pain intensity and frailty after the intervention, and an improvement in physical performance after the intervention and after 3 months.
","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Otones', 'Affiliation': 'San Andrés Primary Care Center, Gerencia Asistencial de Atención Primaria, Alberto Palacios, 22, 28021, Madrid, Spain. pedro.otones@salud.madrid.org.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'García', 'Affiliation': 'Nursing Department, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Sanz', 'Affiliation': 'Research Unit, Gerencia Asistencial de Atención Primaria, Madrid, Spain.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'Pedraz', 'Affiliation': 'Nursing Department, Universidad Autónoma de Madrid, Madrid, Spain.'}]",BMC geriatrics,['10.1186/s12877-020-01805-3']
2041,33032560,Skin and subcutaneous fascia closure at caesarean section to reduce wound complications: the closure randomised trial.,"BACKGROUND


Wound infection is a common complication following caesarean section. Factors influencing the risk of infection may include the suture material for skin closure, and closure of the subcutaneous fascia. We assessed the effect of skin closure with absorbable versus non-absorbable suture, and closure versus non-closure of the subcutaneous fascia on risk of wound infection following Caesarean section.
METHODS


Women undergoing caesarean birth at an Adelaide maternity hospital were eligible for recruitment to a randomised trial using a 2 × 2 factorial design. Women were randomised to either closure or non-closure of the subcutaneous fascia and to subcuticular skin closure with an absorbable or non-absorbable suture. Participants were randomised to each of the two interventions into one of 4 possible groups: Group 1 - non-absorbable skin suture and non-closure of the subcutaneous fascia; Group 2 - absorbable skin suture and non-closure of the subcutaneous fascia; Group 3 - non-absorbable skin suture and closure of the subcutaneous fascia; and Group 4 - absorbable skin suture and closure of the subcutaneous fascia. The primary outcomes were reported wound infection and wound haematoma or seroma within the first 30 days after birth.
RESULTS


A total of 851 women were recruited and randomised, with 849 women included in the analyses (Group 1: 216 women; Group 2: 212 women; Group 3: 212 women; Group 4: 211 women). In women who underwent fascia closure, there was a statistically significant increase in risk of wound infection within 30 days post-operatively for those who had skin closure with an absorbable suture (Group 4), compared with women who had skin closure with a non-absorbable suture (Group 3) (adjusted RR 2.17; 95% CI 1.05, 4.45; p = 0.035). There was no significant difference in risk of wound infection for absorbable vs non-absorbable sutures in women who did not undergo fascia closure.
CONCLUSION


The combination of subcutaneous fascia closure and skin closure with an absorbable suture may be associated with an increased risk of reported wound infection after caesarean section.
TRIAL REGISTRATION


Prospectively registered with the Australian and New Zealand Clinical Trials Registry, number ACTRN12608000143325 , on the 20th March, 2008.",2020,"There was no significant difference in risk of wound infection for absorbable vs non-absorbable sutures in women who did not undergo fascia closure.
","['Women undergoing caesarean birth at an Adelaide maternity hospital were eligible for recruitment to a randomised trial using a 2\u2009×\u20092 factorial design', 'A total of 851 women were recruited and randomised, with 849 women included in the analyses (Group 1: 216 women; Group 2: 212 women; Group 3: 212 women; Group 4: 211 women']","['Skin and subcutaneous fascia closure at caesarean section', 'absorbable suture', 'closure or non-closure of the subcutaneous fascia and to subcuticular skin closure with an absorbable or non-absorbable suture', 'subcutaneous fascia closure and skin closure with an absorbable suture', 'Group 1 - non-absorbable skin suture and non-closure of the subcutaneous fascia; Group 2 - absorbable skin suture and non-closure of the subcutaneous fascia; Group 3 - non-absorbable skin suture and closure of the subcutaneous fascia; and Group 4 - absorbable skin suture and closure of the subcutaneous fascia', 'skin closure with absorbable versus non-absorbable suture, and closure versus non-closure of the subcutaneous fascia']","['wound complications', 'risk of wound infection', 'wound infection and wound haematoma or seroma within the first 30\u2009days after birth']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0020010', 'cui_str': 'Maternity Hospitals'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0461643', 'cui_str': 'Absorbable suture'}, {'cui': 'C0563304', 'cui_str': 'Subcuticular'}, {'cui': 'C0461628', 'cui_str': 'Non-absorbable suture'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0191408', 'cui_str': 'Closure of skin by suture'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}]","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0281860', 'cui_str': 'Wound hematoma'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",851.0,0.157617,"There was no significant difference in risk of wound infection for absorbable vs non-absorbable sutures in women who did not undergo fascia closure.
","[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Poprzeczny', 'Affiliation': 'The University of Adelaide, The Robinson Research Institute, and Discipline of Obstetrics and Gynaecology, Adelaide, South Australia, Australia.'}, {'ForeName': 'Rosalie M', 'Initials': 'RM', 'LastName': 'Grivell', 'Affiliation': 'Flinders Medical Centre, Department of Obstetrics and Gynaecology, Southern Adelaide Local Health Network, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Louise', 'Affiliation': 'The University of Adelaide, The Robinson Research Institute, and Discipline of Obstetrics and Gynaecology, Adelaide, South Australia, Australia.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Deussen', 'Affiliation': 'The University of Adelaide, The Robinson Research Institute, and Discipline of Obstetrics and Gynaecology, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jodie M', 'Initials': 'JM', 'LastName': 'Dodd', 'Affiliation': 'The University of Adelaide, The Robinson Research Institute, and Discipline of Obstetrics and Gynaecology, Adelaide, South Australia, Australia. Jodie.dodd@adelaide.edu.au.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03305-z']
2042,33032180,A prospective randomized controlled trial on the value of prophylactic oral nutritional supplementation in locally advanced nasopharyngeal carcinoma patients receiving chemo-radiotherapy.,"OBJECTIVES


We investigated the effect of prophylactic oral nutrition supplements (ONS) in locally advanced nasopharyngeal carcinoma patients receiving neoadjuvant chemotherapy and concurrent chemoradiotherapy (CCRT).
METHODS


Eligible patients were randomly assigned to an intervention or control group. Patients in the intervention group were supported with prophylactic ONS from the beginning of CCRT. The control group received nutritional support only when necessary. Bodyweight, hematological indexes, nutritional status, and quality of life were measured at baseline and before, during, and after RT.
RESULTS


We evaluated 114 patients from October 2016 to May 2018. More than half of patients experienced significant weight loss during CCRT, which continued for three months after radiotherapy (RT). Compared to baseline, the rate of weight loss ≥ 5% before, during, at the end of RT, and one and three months after RT were 3.5%, 28.9%, 51.8%, 61.4%, and 61.4%, respectively. Nutritional status and global health status scores progressively decreased during treatment. The rate of RT interruption was higher in the control group than in the intervention group (7.14% vs. 0%, χ 2  = 4.29, P = 0.04). More patients experienced concurrent chemotherapy interruption in the control group than in the intervention group (28.57% vs 10.34%, χ 2  = 6.08, P = 0.01). There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
CONCLUSIONS


Malnutrition and weight loss progressively increased during treatment. Prophylactic ONS can improve tolerance to CCRT, but it offers no advantage on short-term weight loss or nutritional assessment scores.",2020,"There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
","['locally advanced nasopharyngeal carcinoma patients receiving', 'Eligible patients', 'locally advanced nasopharyngeal carcinoma patients receiving neoadjuvant chemotherapy and concurrent chemoradiotherapy (CCRT', '114 patients from October 2016 to May 2018']","['Prophylactic ONS', 'prophylactic oral nutrition supplements (ONS', 'chemo-radiotherapy', 'prophylactic ONS', 'nutritional support', 'prophylactic oral nutritional supplementation']","['weight loss', 'Nutritional status and global health status scores', 'concurrent chemotherapy interruption', 'rate of weight loss', 'rate of RT interruption', 'Bodyweight, hematological indexes, nutritional status, and quality of life', 'weight loss, nutritional status, quality of life, and global health status']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C4708785', 'cui_str': '114'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",114.0,0.0467853,"There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China. Electronic address: huangshuang@zjcc.org.cn.'}, {'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Piao', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Caineng', 'Initials': 'C', 'LastName': 'Cao', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Hangzhou YITU Healthcare Technology Co., Ltd, Xihu District, Hangzhou 310012, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sheng', 'Affiliation': 'Hangzhou YITU Healthcare Technology Co., Ltd, Xihu District, Hangzhou 310012, China.'}, {'ForeName': 'Zekai', 'Initials': 'Z', 'LastName': 'Shu', 'Affiliation': 'The 2nd Clinical Medical College of Zhejiang, Chinese Medical University, No. 534, Binwen Road, Hangzhou 310053, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Hua', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Qiaoying', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Xiaozhong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China. Electronic address: chenyy@zjcc.org.cn.'}]",Oral oncology,['10.1016/j.oraloncology.2020.105025']
2043,33032234,Periodontal treatment and vascular inflammation in patients with advanced peripheral arterial disease: A randomized controlled trial.,"BACKGROUND AND AIMS


Observational studies support an association between periodontitis and cardiovascular diseases. The study objective was to assess vascular inflammation after periodontal treatment in patients with peripheral arterial disease.
METHODS


Ninety patients with peripheral arterial disease (PAD) and severe periodontitis were enrolled in a randomized, controlled trial. Thirty patients underwent non-surgical periodontal therapy and received additional systemic antibiotics (PT1 group), while 30 patients received the same therapy without antibiotics (PT2 group). The remaining thirty patients did not receive periodontal therapy (CG, control group). The primary outcome of this treatment was a reduction in vascular inflammation three months after periodontal treatment as determined by  18 F-FDG PET/CT values. Secondary outcomes were changes in the inflamed periodontal surface area (PISA) and other periodontal parameters, changes in vascular biomarkers, and adverse cardiovascular events.
RESULTS


After three months of treatment, a significant improvement in periodontal health was observed in the treatment groups. However, no difference in the primary outcome in the aorta was observed in the three study groups (median target to background ratio follow-up/baseline, PT1 1.00; 95% CI 0.97-1.10, PT2 1.00; 95% CI 0.98-1.1, CG 1.1; 95% CI 0.99-1.1, p = 0.75). No significant differences were detected in most diseased segments and active segments. In addition, no differences were observed in  18 F-FDG uptake in the carotid, iliac, femoral, and popliteal arteries. No differences with regard to relative changes in vascular biomarkers were noted, and no serious cardiovascular adverse events occurred.
CONCLUSIONS


Periodontal treatment was effective and safe but did not reduce vascular inflammation in patients with PAD.",2020,"In addition, no differences were observed in  18 F-FDG uptake in the carotid, iliac, femoral, and popliteal arteries.","['Ninety patients with peripheral arterial disease (PAD) and severe periodontitis', 'patients with peripheral arterial disease', 'patients with PAD', 'patients with advanced peripheral arterial disease', 'Thirty patients underwent']","['non-surgical periodontal therapy and received additional systemic antibiotics (PT1 group), while 30 patients received the same therapy without antibiotics (PT2 group']","['vascular inflammation', 'periodontal health', 'serious cardiovascular adverse events', 'vascular biomarkers', 'reduction in vascular inflammation', 'inflamed periodontal surface area (PISA) and other periodontal parameters, changes in vascular biomarkers, and adverse cardiovascular events']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332391', 'cui_str': 'pT1 category'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332392', 'cui_str': 'pT2 category'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",30.0,0.258351,"In addition, no differences were observed in  18 F-FDG uptake in the carotid, iliac, femoral, and popliteal arteries.","[{'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Seinost', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria. Electronic address: gerald.seinost@medunigraz.at.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Horina', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Behrouz', 'Initials': 'B', 'LastName': 'Arefnia', 'Affiliation': 'Division of Operative Dentistry, Periodontology and Prosthodontics, Department of Dental Medicine and Oral Health, Medical University of Graz, Austria.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Kulnik', 'Affiliation': 'Division of Nuclear Medicine Radiology, Department of Radiology, Medical University of Graz, Austria.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kerschbaumer', 'Affiliation': 'Division of Nuclear Medicine Radiology, Department of Radiology, Medical University of Graz, Austria.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Quehenberger', 'Affiliation': 'Institute for Medical Informatics, Statistics and Documentation, Medical University of Graz, Austria.'}, {'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Muster', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Gütl', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Sieglinde', 'Initials': 'S', 'LastName': 'Zelzer', 'Affiliation': 'Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gasser', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Mangge', 'Affiliation': 'Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria.'}, {'ForeName': 'Reingard', 'Initials': 'R', 'LastName': 'Aigner', 'Affiliation': 'Division of Nuclear Medicine Radiology, Department of Radiology, Medical University of Graz, Austria.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brodmann', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Wimmer', 'Affiliation': 'Division of Operative Dentistry, Periodontology and Prosthodontics, Department of Dental Medicine and Oral Health, Medical University of Graz, Austria.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.09.019']
2044,33032256,Effects of familial Mediterranean fever on the middle ear.,"OBJECTIVE


To evaluate middle and inner ear function and hearing status of children with familial Mediterranean fever (FMF).
METHODS


We assigned 56 patients with FMF to the study group and 52 healthy volunteers to the control group. The mean age of patients in the study and control groups were 10.10 ± 3.70 and 9.77 ± 3.74 years, respectively. Physical examination and hearing evaluation were performed in both groups. The audiological test battery included 226-Hz tympanometry, pure tone audiometric evaluation, acoustic stapedial reflex measurements, distortion product otoacoustic emission recording, and wide-band tympanometry assessment.
RESULTS


The groups were similar in age and sex ratio (p > 0.05 for both comparisons). Pure tone audiogram and distortion product otoacoustic emission results were also similar for both groups (p > 0.05). The ipsilateral acoustic stapedial reflex were present in both of the groups and all participants had Type A tympanogram. The contralateral acoustic stapedial reflex thresholds were significantly higher in the familial Mediterranean fever group (p < 0.05 for all comparisons). The ambient and peak pressure absorbance values of wide-band tympanometry were significantly lower at 2000 Hz and significantly higher at 4000 Hz in the familial Mediterranean fever group (p < 0.05 for both comparisons). The severity and duration of disease adversely affected the absorbance values of wide-band tympanometry at 2000 and 4000 Hz (p < 0.05).
CONCLUSION


To our knowledge, this is the first study to demonstrate the adverse subclinical effects of familial Mediterranean fever on the middle ear. We recommend that children diagnosed with FMF should be closely monitored for future clinical middle ear pathologies.",2020,The ipsilateral acoustic stapedial reflex were present in both of the groups and all participants had Type A tympanogram.,"['56 patients with FMF to the study group and 52 healthy volunteers to the control group', 'familial Mediterranean fever on the middle ear', 'children with familial Mediterranean fever (FMF', 'children diagnosed with FMF']",[],"['contralateral acoustic stapedial reflex thresholds', 'ambient and peak pressure absorbance values of wide-band tympanometry', '226-Hz tympanometry, pure tone audiometric evaluation, acoustic stapedial reflex measurements, distortion product otoacoustic emission recording, and wide-band tympanometry assessment', 'absorbance values of wide-band tympanometry', 'Physical examination and hearing evaluation', 'ipsilateral acoustic stapedial reflex']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031069', 'cui_str': 'Familial Mediterranean fever'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",[],"[{'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0428765', 'cui_str': 'Stapedial reflex threshold'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C1268822', 'cui_str': 'Optical density'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0085853', 'cui_str': 'Tympanometry testing'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034934', 'cui_str': 'Stapedial reflex'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0162525', 'cui_str': 'Spontaneous Otoacoustic Emissions'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}]",56.0,0.0334702,The ipsilateral acoustic stapedial reflex were present in both of the groups and all participants had Type A tympanogram.,"[{'ForeName': 'Asli Cakir', 'Initials': 'AC', 'LastName': 'Cetin', 'Affiliation': 'Department of Otorhinolaryngology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: asli.cakir@deu.edu.tr.'}, {'ForeName': 'Ceyhun', 'Initials': 'C', 'LastName': 'Acari', 'Affiliation': 'Department of Pediatrics, Section of Immunology and Rheumatology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: ceyhun.acari@deu.edu.tr.'}, {'ForeName': 'Hande', 'Initials': 'H', 'LastName': 'Evin', 'Affiliation': 'Department of Otorhinolaryngology, Unit of Speech, Hearing & Balance, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: handeevin1@gmail.com.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Omer Ikiz', 'Affiliation': 'Department of Otorhinolaryngology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: ahmet.ikiz@deu.edu.tr.'}, {'ForeName': 'Gunay', 'Initials': 'G', 'LastName': 'Kirkim', 'Affiliation': 'Department of Otorhinolaryngology, Unit of Speech, Hearing & Balance, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: gunay.kirkim@deu.edu.tr.'}, {'ForeName': 'Erbil', 'Initials': 'E', 'LastName': 'Unsal', 'Affiliation': 'Department of Pediatrics, Section of Immunology and Rheumatology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: erbil.unsal@deu.edu.tr.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110417']
2045,33038320,Effect of restricted retail merchandising of discretionary food and beverages on population diet: a pragmatic randomised controlled trial.,"BACKGROUND


The effectiveness of healthy food promotion on food and beverage sales in real-world food retail settings has been shown in randomised trials. The effectiveness of restrictions on the promotion of unhealthy food is, however, less clear. We aimed to assess the effect of restricted unhealthy food promotion, specifically those items contributing most to free sugar sales, on food and beverage sales.
METHODS


In this community-level pragmatic, partially randomised, parallel group trial, stores were randomly assigned by a statistician using a single sequence of random assignments to the intervention group, in which a co-designed strategy restricted merchandising of unhealthy food, or to a control group of usual retail practice. The trial was done in partnership with an organisation operating 25 stores in remote Australia. The primary analysis was based on difference in weekly sales with the strategy compared with no strategy in free sugar from all foods and beverages (g/total MJ; primary outcome), targeted food or beverages (weight and free sugars; g/total MJ), and gross profit (AU$) using mixed models. This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001588280.
FINDINGS


Between June 13 and Aug 15, 2018, 20 stores were recruited; ten stores were randomly assigned to the intervention group and ten stores to the control group. The trial was done between Sept 2 and Dec 2, 2018. The Healthy Stores 2020 strategy resulted in a reduction in sales of free sugar of 2·8% (95% CI -4·9 to -0·7). Targeted beverages were reduced by 8·4% (-12·3 to -4·3) and associated free sugar by 6·8% (-10·9 to -2·6), sugar-sweetened soft drinks by 13·2% (-18·5 to -7·6), and associated free sugar by 13·4% (-18·7 to -7·7). Reductions in sales of free sugar from confectionery of 7·5% (-14·3 to -0·2) and in weight sold (-4·6%, -11·1 to 2·3) resulted; however, the reduction in weight was not statistically significant. No differences in sales of table sugar and sweet biscuits were observed. Gross profit was not impacted adversely; a small increase resulted (5·3%, 0·3 to 10·5).
INTERPRETATION


Restricted merchandising of unhealthy foods and beverages, while allowing for complementary merchandising of healthier foods and beverages in a real-world store setting and co-designed with retailers, can achieve both public health and business relevant gains.
FUNDING


Australian National Health and Medical Research Council.",2020,"Targeted beverages were reduced by 8·4% (-12·3 to -4·3) and associated free sugar by 6·8% (-10·9 to -2·6), sugar-sweetened soft drinks by 13·2% (-18·5 to -7·6), and associated free sugar by 13·4% (-18·7 to -7·7).","['partnership with an organisation operating 25 stores in remote Australia', 'Between June 13 and Aug 15, 2018, 20 stores were recruited; ten stores', 'population diet']",['restricted retail merchandising of discretionary food and beverages'],"['targeted food or beverages (weight and free sugars; g/total MJ), and gross profit (AU', 'Targeted beverages', 'sales of table sugar and sweet biscuits', 'reduction in weight', 'sales of free sugar']","[{'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0524819', 'cui_str': 'Foods and drinks'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0036070', 'cui_str': 'Sales'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",20.0,0.138025,"Targeted beverages were reduced by 8·4% (-12·3 to -4·3) and associated free sugar by 6·8% (-10·9 to -2·6), sugar-sweetened soft drinks by 13·2% (-18·5 to -7·6), and associated free sugar by 13·4% (-18·7 to -7·7).","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Brimblecombe', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Melbourne, VIC, Australia; Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia. Electronic address: julie.brimblecombe@monash.edu.au.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McMahon', 'Affiliation': 'Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Ferguson', 'Affiliation': 'Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia; School of Public Health, Faculty of Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Khia', 'Initials': 'K', 'LastName': 'De Silva', 'Affiliation': 'Arnhem Land Progress Aboriginal Corporation, Darwin, NT, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Peeters', 'Affiliation': 'Institute for Health Transformation, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Miles', 'Affiliation': 'Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wycherley', 'Affiliation': 'Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia; Alliance for Research in Exercise, Nutrition and Activity, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Leia', 'Initials': 'L', 'LastName': 'Minaker', 'Affiliation': 'School of Planning, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Greenacre', 'Affiliation': 'Business School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gunther', 'Affiliation': 'Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Chappell', 'Affiliation': 'Arnhem Land Progress Aboriginal Corporation, Darwin, NT, Australia.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Chatfield', 'Affiliation': 'Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia; School of Public Health, Faculty of Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Mah', 'Affiliation': 'Faculty of Health, Dalhousie University, Halifax, NS, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}]",The Lancet. Planetary health,['10.1016/S2542-5196(20)30202-3']
2046,33038505,The design of a randomized controlled trial to evaluate multi-dimensional effects of a section 1115 Medicaid demonstration waiver with community engagement requirements.,"Section 1115 demonstration waivers provide a mechanism for states to implement changes to their Medicaid programs. While such waivers are mandated to include evaluations of their impact, randomization - the gold standard for assessing causality - has not typically been a consideration. In a critical departure, the Commonwealth of Kentucky opted to pursue a two-arm randomized controlled trial (RCT) for their controversial 2018 Medicaid Demonstration waiver, which included work requirements as a condition for the subset of beneficiaries deemed able-bodied to maintain eligibility for benefits. Beneficiaries were randomized 9:1 to the new waiver program or a control group who would retain their current benefits as part of the existing Medicaid expansion program. To address potential bias from differential attrition from the Medicaid program that would accrue from solely analyzing administrative data, our team designed a rich, prospective, longitudinal survey to collect primary and secondary outcomes from six categories of interest to policymakers: insurance coverage, health care utilization and quality, health behaviors, socioeconomic measures, personal finances, and health outcomes. At baseline, a subset of survey participants was invited to participate in the collection of biometric samples via in-person follow-up visits, and a cross-section were also invited to participate in qualitative interviews. While the demonstration waiver was terminated before the program began, our study design illustrates that it is possible for other researchers and state agencies seeking to evaluate Medicaid demonstration waivers and other demonstration policies to work together to implement high quality randomized trials - even for controversial policies.",2020,Beneficiaries were randomized 9:1 to the new waiver program or a control group who would retain their current benefits as part of the existing Medicaid expansion program.,['section 1115 Medicaid demonstration waiver with community engagement requirements'],['control group who would retain their current benefits as part of the existing Medicaid expansion program'],[],"[{'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0281739,Beneficiaries were randomized 9:1 to the new waiver program or a control group who would retain their current benefits as part of the existing Medicaid expansion program.,"[{'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Linn', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Underhill', 'Affiliation': 'Columbia Law School, New York, NY, USA; Department of Population and Family Health, Mailman School of Public Heath, Columbia University, New York, NY, USA.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Dixon', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Elizabeth F', 'Initials': 'EF', 'LastName': 'Bair', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Ferrell', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Margrethe E', 'Initials': 'ME', 'LastName': 'Montgomery', 'Affiliation': 'National Opinion Research Center at the University of Chicago, Bethesda MD and Chicago, IL, USA.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medicine, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Center for Health Equity Research and Promotion, Cresencz VA Medical Center, Philadelphia, USA.'}, {'ForeName': 'Atheendar S', 'Initials': 'AS', 'LastName': 'Venkataramani', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA. Electronic address: atheenv@pennmedicine.upenn.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106173']
2047,33038506,A mHealth intervention to preserve and promote ideal cardiovascular health in college students: Design and protocol of a cluster randomized controlled trial.,"BACKGROUND


Cardiovascular disease (CVD) remains the leading cause of death globally. Seven health factors are associated with ideal cardiovascular health: being a non-smoker; not overweight; physically active; having a healthy diet; and normal blood pressure; fasting plasma glucose and cholesterol. Whereas approximately half of U.S. youth have ideal levels in at least 5 of the 7 components of cardiovascular health, this proportion falls to 16% by adulthood.
OBJECTIVE


We will evaluate whether the NUYou cardiovascular mHealth intervention is more effective than an active comparator to promote cardiovascular health during the transition to young adulthood.
METHODS


302 incoming freshmen at a midwest university will be cluster randomized by dormitory into one of two mHealth intervention groups: 1) Cardiovascular Health (CVH), addressing behaviors related to CVD risk; or 2) Whole Health (WH), addressing behaviors unrelated to CVD. Both groups will receive smartphone applications, co-designed with students to help them manage time, interact with other participants via social media, and report health behaviors weekly. The CVH group will also have self-monitoring features to track their risk behaviors. Cardiovascular health will be assessed at the beginning of freshman year and the end of freshman and sophomore years. Linear mixed models will be used to compare groups on a composite of the seven cardiovascular-related health factors.
SIGNIFICANCE


This is the first entirely technology-mediated multiple health behavior change intervention delivered to college students to promote cardiovascular health. Findings will inform the potential for primordial prevention in young adulthood.
TRIAL REGISTRATION NUMBER


clinicaltrials.gov #NCT02496728.",2020,"Whereas approximately half of U.S. youth have ideal levels in at least 5 of the 7 components of cardiovascular health, this proportion falls to 16% by adulthood.
","['young adulthood', 'college students', '302 incoming freshmen at a midwest university will be cluster randomized by dormitory into one of two mHealth intervention groups: 1']","['Cardiovascular Health (CVH), addressing behaviors related to CVD risk; or 2) Whole Health (WH), addressing behaviors unrelated to CVD', 'CVH', 'NUYou cardiovascular mHealth intervention']",['Cardiovascular health'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",302.0,0.114352,"Whereas approximately half of U.S. youth have ideal levels in at least 5 of the 7 components of cardiovascular health, this proportion falls to 16% by adulthood.
","[{'ForeName': 'Angela F', 'Initials': 'AF', 'LastName': 'Pfammatter', 'Affiliation': 'Northwestern University Feinberg School of Medicine, United States of America. Electronic address: angela@northwestern.edu.'}, {'ForeName': 'Katrina E', 'Initials': 'KE', 'LastName': 'Champion', 'Affiliation': 'University of Sydney, Australia. Electronic address: katrina.champion@sydney.edu.au.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Finch', 'Affiliation': 'NORC at the University of Chicago, United States of America. Electronic address: Finch-laura@norc.org.'}, {'ForeName': 'Juned', 'Initials': 'J', 'LastName': 'Siddique', 'Affiliation': 'Northwestern University Feinberg School of Medicine, United States of America. Electronic address: Siddique@northwestern.edu.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'University of Chicago, United States of America. Electronic address: hedeker@uchicago.edu.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Spring', 'Affiliation': 'Northwestern University Feinberg School of Medicine, United States of America. Electronic address: bspring@northwestern.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106162']
2048,33022140,Clinical and demographic characteristics of people who smoke versus inject crystalline methamphetamine in Australia: Findings from a pharmacotherapy trial.,"INTRODUCTION AND AIMS


There has been a rapid increase in smoking crystalline methamphetamine in Australia. We compare the clinical and demographic characteristics of those who smoke versus inject the drug in a cohort of people who use methamphetamine.
DESIGN AND METHODS


Participants (N = 151) were dependent on methamphetamine, aged 18-60 years, enrolled in a pharmacotherapy trial for methamphetamine dependence, and reported either injecting (n = 54) or smoking (n = 97) methamphetamine. Measures included the Timeline Followback, Severity of Dependence Scale, Amphetamine Withdrawal Questionnaire, Craving Experience Questionnaire and the Brief Psychiatric Rating Scale (symptoms of depression, hostility, psychosis and suicidality). Simultaneous regression was used to identify independent demographic correlates of smoking methamphetamine and to compare the clinical characteristics of participants who smoked versus injected.
RESULTS


Compared to participants who injected methamphetamine, those who smoked methamphetamine were younger and less likely to be unemployed, have a prison history or live alone. Participants who smoked methamphetamine used methamphetamine on more days in the past 4 weeks than participants who injected methamphetamine (26 vs. 19 days, P = 0.001); they did not differ significantly in their severity of methamphetamine dependence, withdrawal, craving or psychiatric symptoms (P > 0.05). After adjustment for demographic differences, participants who smoked had lower craving [b (SE) = -1.1 (0.5), P = 0.021] and were less likely to report psychotic symptoms [b (SE) = -1.8 (0.7), P = 0.013] or antidepressant use [b (SE) = -1.1 (0.5), P = 0.022].
DISCUSSION AND CONCLUSIONS


Smoking crystalline methamphetamine is associated with a younger less marginalised demographic profile than injecting methamphetamine, but a similarly severe clinical profile.",2020,"DISCUSSION AND CONCLUSIONS


Smoking crystalline methamphetamine is associated with a younger less marginalised demographic profile than injecting methamphetamine, but a similarly severe clinical profile.","['people who smoke versus inject crystalline methamphetamine in Australia', 'participants who smoked versus injected', 'Participants (N = 151) were dependent on methamphetamine, aged 18-60\u2009years, enrolled in a pharmacotherapy trial for methamphetamine dependence, and reported either injecting (n = 54) or smoking (n = 97']","['antidepressant use [b (SE) ', 'methamphetamine']","['severity of methamphetamine dependence, withdrawal, craving or psychiatric symptoms', 'Timeline Followback, Severity of Dependence Scale, Amphetamine Withdrawal Questionnaire, Craving Experience Questionnaire and the Brief Psychiatric Rating Scale (symptoms of depression, hostility, psychosis and suicidality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0444626', 'cui_str': 'Crystal'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0236665', 'cui_str': 'Amphetamine withdrawal'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]",151.0,0.0762108,"DISCUSSION AND CONCLUSIONS


Smoking crystalline methamphetamine is associated with a younger less marginalised demographic profile than injecting methamphetamine, but a similarly severe clinical profile.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McKETIN', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Quinn', 'Affiliation': 'Behaviours and Health Risks Program, Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Higgs', 'Affiliation': 'Behaviours and Health Risks Program, Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'Deakin University, IMPACT-The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Dean', 'Affiliation': 'Deakin University, IMPACT-The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia.'}, {'ForeName': 'Alyna', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'Deakin University, IMPACT-The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kelly', 'Affiliation': 'Illawarra Health and Medical Research Institute and School of Psychology, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Dan I', 'Initials': 'DI', 'LastName': 'Lubman', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Carter', 'Affiliation': 'Centre for Brain and Mental Health Priority Research Centre, School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Baker', 'Affiliation': 'Centre for Brain and Mental Health Priority Research Centre, School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Manning', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'Thomas', 'Affiliation': 'Illawarra Health and Medical Research Institute and School of Psychology, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Ramez', 'Initials': 'R', 'LastName': 'Bathish', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Dayle', 'Initials': 'D', 'LastName': 'Raftery', 'Affiliation': 'Illawarra Health and Medical Research Institute and School of Psychology, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Saunders', 'Affiliation': 'Deakin University, IMPACT-The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wrobel', 'Affiliation': 'Deakin University, IMPACT-The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia.'}, {'ForeName': 'Alcyone', 'Initials': 'A', 'LastName': 'Meehan', 'Affiliation': 'Deakin University, IMPACT-The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Sinclair', 'Affiliation': 'Drug and Alcohol Services, Illawarra Shoalhaven Local Health District, Wollongong, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reid', 'Affiliation': 'Drug and Alcohol Services, Illawarra Shoalhaven Local Health District, Wollongong, Australia.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Arunogiri', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Hill', 'Affiliation': 'Mental Health and Drug and Alcohol Services, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Cordaro', 'Affiliation': 'Drug and Alcohol Services, Illawarra Shoalhaven Local Health District, Wollongong, Australia.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Dietze', 'Affiliation': 'Behaviours and Health Risks Program, Burnet Institute, Melbourne, Australia.'}]",Drug and alcohol review,['10.1111/dar.13183']
2049,33025927,Effectiveness of Toothpaste Containing REFIX Technology against Dentin Hypersensitivity: A Randomized Clinical Study.,"AIM


This clinical study aimed to evaluate the efficacy of a toothpaste containing a proprietary REFIX technology (Regenerador + Sensitive DentalClean, Rabbit Corp) against dentin hypersensitivity.
MATERIALS AND METHODS


Fifty-three volunteers who fulfilled the inclusion criteria and signed the consent form were included. They were examined for dentin hypersensitivity. The participants received a 1-second blast of air, and the tooth sensitivity, from 0 to 10, was immediately evaluated using a visual analog scale (VAS). Then, the participants brushed their teeth with the multifunctional toothpaste, and dentin hypersensitivity was tested a second time using the same scale. The participants continued to use the toothpaste three times a day for 1 week, after which dentin hypersensitivity was recorded for the third time. Data were statistically analyzed using analysis of variance (ANOVA) and Tukey's test ( α  = 0.05).
RESULTS


The mean patient age was 40 years, and 70% of the 53 subjects were female. There was a significant reduction in dentin hypersensitivity immediately after using the toothpaste and after 1 week. The baseline mean patient-reported pain score was severe (6.5 ± 2.4). Immediately after the first use of the toothpaste, the mean reported pain significantly decreased to mild pain (2.5 ± 2.5) ( p  < 0.05). After 1 week of consistent use of the toothpaste, the pain score reduced significantly (0.7 ± 1.2) ( p  < 0.05), and most participants reported no pain, demonstrating the effectiveness of the REFIX technology against dentin hypersensitivity.
CONCLUSION


This clinical trial shows that the use of the phosphate-based desensitizing toothpaste containing REFIX technology significantly reduces dentin hypersensitivity after 1 week of consistent use.
CLINICAL SIGNIFICANCE


The absence of pain, a desired clinical condition in patients with dentin hypersensitivity, was reached with the use of desensitizing toothpaste containing REFIX technology after 1 week of use. Such condition positively impacts quality of life, providing a healthier daily routine for patients.",2020,There was a significant reduction in dentin hypersensitivity immediately after using the toothpaste and after 1 week.,"['Fifty-three volunteers who fulfilled the inclusion criteria and signed the consent form were included', 'patients with dentin hypersensitivity', 'against Dentin Hypersensitivity', 'mean patient age was 40 years, and 70% of the 53 subjects were female', 'patients']","['toothpaste containing a proprietary REFIX technology (Regenerador + Sensitive DentalClean, Rabbit Corp', 'Toothpaste Containing REFIX Technology']","['visual analog scale (VAS', 'pain score', 'mild pain', 'dentin hypersensitivity']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0324889', 'cui_str': 'Oryctolagus cuniculus'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0278138', 'cui_str': 'Mild pain'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}]",53.0,0.033617,There was a significant reduction in dentin hypersensitivity immediately after using the toothpaste and after 1 week.,"[{'ForeName': 'Fabiano V', 'Initials': 'FV', 'LastName': 'Vilhena', 'Affiliation': 'Trials, Research and Development, Inc.'}, {'ForeName': 'Mackeler R', 'Initials': 'MR', 'LastName': 'Polassi', 'Affiliation': 'Biotechnology and Innovation in Health Program, Anhanguera University of São Paulo (UNIAN-SP), São Paulo, Brazil.'}, {'ForeName': 'Eloisa Ac', 'Initials': 'EA', 'LastName': 'Paloco', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University North of Paraná-UNOPAR, Londrina, Paraná, Brazil.'}, {'ForeName': 'Roberta Cb', 'Initials': 'RC', 'LastName': 'Alonso', 'Affiliation': 'Department of Dentistry, School of Dentistry, Metropolitan University of Santos, Santos, São Paulo, Brazil; University of Mogi das Cruzes, Mogi das Cruzes, São Paulo, Brazil.'}, {'ForeName': 'Ricardo D', 'Initials': 'RD', 'LastName': 'Guiraldo', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University North of Paraná-UNOPAR, Londrina, Paraná, Brazil.'}, {'ForeName': 'Paulo Hp', 'Initials': 'PH', 'LastName': ""D'Alpino"", 'Affiliation': 'Biotechnology and Innovation in Health Program, Anhanguera University of São Paulo (UNIAN-SP), São Paulo, Brazil, Phone: +55 11 35128412, e-mail: paulodalpino@gmail.com.'}]",The journal of contemporary dental practice,[]
2050,32817692,Gaining traction: Promising shifts in gender norms and intimate partner violence in the context of a community-based HIV prevention trial in South Africa.,"BACKGROUND


HIV and violence prevention programs increasingly seek to transform gender norms among participants, yet how to do so at the community level, and subsequent pathways to behavior change, remain poorly understood. We assessed shifts in endorsement of equitable gender norms, and intimate partner violence (IPV), during the three-year community-based trial of Tsima, an HIV 'treatment as prevention' intervention in rural South Africa.
METHODS


Cross-sectional household surveys were conducted with men and women ages 18-49 years, in 8 intervention and 7 control communities, at 2014-baseline (n = 1,149) and 2018-endline (n = 1,189). Endorsement of equitable gender norms was measured by the GEM Scale. Intent-to-treat analyses assessed intervention effects and change over time. Qualitative research with 59 community members and 38 staff examined the change process.
RESULTS


Nearly two-thirds of men and half of women in intervention communities had heard of the intervention/seen the logo; half of these had attended a two-day workshop. Regression analyses showed a 15% improvement in GEM Scale score over time, irrespective of the intervention, among men (p<0.001) and women (p<0.001). Younger women (ages 18-29) had a decreased odds of reporting IPV in intervention vs. control communities (aOR 0.53; p<0.05). Qualitative data suggest that gender norms shifts may be linked to increased media access (via satellite TV/smartphones) and consequent exposure to serial dramas modeling equitable relationships and negatively portraying violence. Tsima's couple communication/conflict resolution skills-building activities, eagerly received by intervention participants, appear to have further supported IPV reductions.
CONCLUSIONS


There was a population-level shift towards greater endorsement of equitable gender norms between 2014-2018, potentially linked with rapid escalation in media access. There was also an intervention effect on reported IPV among young women, likely owing to improved couple communication. Societal-level gender norm shifts may create enabling environments for interventions to find new traction for violence and HIV-related behavior change.",2020,Nearly two-thirds of men and half of women in intervention communities had heard of the intervention/seen the logo; half of these had attended a two-day workshop.,"['59 community members and 38 staff examined the change process', 'Cross-sectional household surveys were conducted with men and women ages 18-49 years, in 8 intervention and 7 control communities, at 2014-baseline (n = 1,149) and 2018-endline (n = 1,189', 'rural South Africa', 'Younger women (ages 18-29']",['Gaining traction'],"['GEM Scale score', 'endorsement of equitable gender norms, and intimate partner violence (IPV']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0040597', 'cui_str': 'Traction'}]","[{'cui': 'C0445501', 'cui_str': 'Gem'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",,0.0629505,Nearly two-thirds of men and half of women in intervention communities had heard of the intervention/seen the logo; half of these had attended a two-day workshop.,"[{'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Gottert', 'Affiliation': 'Population Council/Project SOAR, Washington, D.C., United States of America.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Pulerwitz', 'Affiliation': 'Population Council/Project SOAR, Washington, D.C., United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Haberland', 'Affiliation': 'Population Council/Project SOAR, Washington, D.C., United States of America.'}, {'ForeName': 'Rhandzekile', 'Initials': 'R', 'LastName': 'Mathebula', 'Affiliation': 'Sonke Gender Justice, Bushbuckridge Local Municipality, South Africa.'}, {'ForeName': 'Dumisani', 'Initials': 'D', 'LastName': 'Rebombo', 'Affiliation': 'Sonke Gender Justice, Bushbuckridge Local Municipality, South Africa.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Spielman', 'Affiliation': 'Population Council/Project SOAR, Washington, D.C., United States of America.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Division of Prevention Science, Department of Medicine, University of California San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'Aimée', 'Initials': 'A', 'LastName': 'Julien', 'Affiliation': 'Department of Epideiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Twine', 'Affiliation': 'MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Peacock', 'Affiliation': 'Sonke Gender Justice, Bushbuckridge Local Municipality, South Africa.'}, {'ForeName': 'Mi-Suk', 'Initials': 'MS', 'LastName': 'Kang Dufour', 'Affiliation': 'Division of Prevention Science, Department of Medicine, University of California San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'F Xavier', 'Initials': 'FX', 'LastName': 'Gómez-Olivé', 'Affiliation': 'MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Pettifor', 'Affiliation': 'Department of Epideiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Sheri A', 'Initials': 'SA', 'LastName': 'Lippman', 'Affiliation': 'Division of Prevention Science, Department of Medicine, University of California San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kahn', 'Affiliation': 'MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}]",PloS one,['10.1371/journal.pone.0237084']
2051,33026938,Randomized Phase III KEYNOTE-181 Study of Pembrolizumab Versus Chemotherapy in Advanced Esophageal Cancer.,"PURPOSE


Patients with advanced esophageal cancer have a poor prognosis and limited treatment options after first-line chemotherapy.
PATIENTS AND METHODS


In this open-label, phase III study, we randomly assigned (1:1) 628 patients with advanced/metastatic squamous cell carcinoma or adenocarcinoma of the esophagus, that progressed after one prior therapy, to pembrolizumab 200 mg every 3 weeks for up to 2 years or chemotherapy (investigator's choice of paclitaxel, docetaxel, or irinotecan). Primary end points were overall survival (OS) in patients with programmed death ligand-1 (PD-L1) combined positive score (CPS) ≥ 10, in patients with squamous cell carcinoma, and in all patients (one-sided α 0.9%, 0.8%, and 0.8%, respectively).
RESULTS


At final analysis, conducted 16 months after the last patient was randomly assigned, OS was prolonged with pembrolizumab versus chemotherapy for patients with CPS ≥ 10 (median, 9.3  v  6.7 months; hazard ratio [HR], 0.69 [95% CI, 0.52 to 0.93];  P  = .0074). Estimated 12-month OS rate was 43% (95% CI, 33.5% to 52.1%) with pembrolizumab versus 20% (95% CI, 13.5% to 28.3%) with chemotherapy. Median OS was 8.2 months versus 7.1 months (HR, 0.78 [95% CI, 0.63 to 0.96];  P  = .0095) in patients with squamous cell carcinoma and 7.1 months versus 7.1 months (HR, 0.89 [95% CI, 0.75 to 1.05];  P  = .0560) in all patients. Grade 3-5 treatment-related adverse events occurred in 18.2% of patients with pembrolizumab versus 40.9% in those who underwent chemotherapy.
CONCLUSION


Pembrolizumab prolonged OS versus chemotherapy as second-line therapy for advanced esophageal cancer in patients with PD-L1 CPS ≥ 10, with fewer treatment-related adverse events.",2020,"Median OS was 8.2 months versus 7.1 months (HR, 0.78","['Patients with advanced esophageal cancer', '628 patients with advanced/metastatic squamous cell carcinoma or adenocarcinoma of the esophagus, that progressed after one prior therapy, to', 'Advanced Esophageal Cancer']","['Pembrolizumab Versus Chemotherapy', 'pembrolizumab', 'Pembrolizumab prolonged OS versus chemotherapy', 'pembrolizumab versus chemotherapy', ""pembrolizumab 200 mg every 3 weeks for up to 2 years or chemotherapy (investigator's choice of paclitaxel, docetaxel, or irinotecan""]","['Median OS', 'overall survival (OS', 'adverse events', 'Estimated 12-month OS rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic'}, {'cui': 'C0279628', 'cui_str': 'Adenocarcinoma of esophagus'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",628.0,0.110357,"Median OS was 8.2 months versus 7.1 months (HR, 0.78","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kojima', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Manish A', 'Initials': 'MA', 'LastName': 'Shah', 'Affiliation': 'Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Francois', 'Affiliation': 'CLCC Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Adenis', 'Affiliation': 'IRCM, Inserm, Université Montpellier, ICM, Montpellier, France.'}, {'ForeName': 'Chih-Hung', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Doi', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Moriwaki', 'Affiliation': 'University of Tsukuba Hospital, Tsukuba, Japan.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Se-Hoon', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Jaafar', 'Initials': 'J', 'LastName': 'Bennouna', 'Affiliation': ""Institut de Cancerologie de L'Ouest, Nantes, France.""}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Enzinger', 'Affiliation': 'Dana Farber Cancer Institute and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Shu-Kui', 'Initials': 'SK', 'LastName': 'Qin', 'Affiliation': 'PLA Cancer Centre of Nanjing Bayi Hospital, Nanjing, China.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ferreira', 'Affiliation': 'Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E., Porto, Portugal.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Jiangsu Cancer Hospital, Nanging, China.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Girotto', 'Affiliation': 'Hospital de Base de Sao Jose do Rio Preto, Sao Jose do Rio Preto, Brazil.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'de la Fouchardiere', 'Affiliation': 'Centre Leon Berard, Lyon, France.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Senellart', 'Affiliation': 'Centre Rene Gauducheau ICO, Saint Herblain, France.'}, {'ForeName': 'Raed', 'Initials': 'R', 'LastName': 'Al-Rajabi', 'Affiliation': 'University of Kansas Cancer Center, Westwood, KS.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Lordick', 'Affiliation': 'University Cancer Center Leipzig, Leipzig, Germany.'}, {'ForeName': 'Ruixue', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ.'}, {'ForeName': 'Shailaja', 'Initials': 'S', 'LastName': 'Suryawanshi', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Bhagia', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ.'}, {'ForeName': 'S Peter', 'Initials': 'SP', 'LastName': 'Kang', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Metges', 'Affiliation': ""CHU Brest - Institut de Cancerologie et d'Hematologie, Arpego Network, Brest, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01888']
2052,33027229,Mechanical insufflation/exsufflation compared with standard of care in patients with pneumonia: A randomised controlled trial.,,2020,,['patients with pneumonia'],['Mechanical insufflation/exsufflation compared with standard of care'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",[],,0.236647,,"[{'ForeName': 'Fredrikke C', 'Initials': 'FC', 'LastName': 'Knudtzen', 'Affiliation': 'From the Department of Infectious Diseases, Odense University Hospital, Denmark (FCK, ISJ), Respiratory Centre South, Odense University Hospital, Denmark (MS), Division of Infection, Immunity and Respiratory Medicine, University of Manchester, and North West Lung Centre, Manchester University NHS Foundation Trust, Manchester, UK (JV).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sprehn', 'Affiliation': ''}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Vestbo', 'Affiliation': ''}, {'ForeName': 'Isik S', 'Initials': 'IS', 'LastName': 'Johansen', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001209']
2053,33027362,Antibiotic prophylaxis in breast cancer surgery. A randomized controlled trial.,"PURPOSE


To assess the effect of antibiotic prophylaxis on surgical site infection (SSI) rates in women undergoing breast cancer surgery in two tertiary hospitals in Brazil.
METHODS


This was a randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 124 women without independent risk factors for SSI were randomly assigned to receive either cefazolin (antibiotic group, n = 62) or placebo (control group, n = 62) as preoperative prophylaxis. After surgery, all surgical wounds were examined once a week, for four weeks, according to the Centers for Disease Control and Prevention definitions and classifications for SSI.
RESULTS


Baseline characteristics were homogeneous between the two groups. Only one patient in the antibiotic group developed SSI, which was classified as superficial incisional. The overall SSI rate was low, with no significant difference between groups.
CONCLUSION


Antibiotic prophylaxis had no significant effect on reducing SSI rates in women without independent risk factors for SSI undergoing breast cancer surgery.",2020,"CONCLUSION


Antibiotic prophylaxis had no significant effect on reducing SSI rates in women without independent risk factors for SSI undergoing breast cancer surgery.","['women undergoing breast cancer surgery in two tertiary hospitals in Brazil', '124 women without independent risk factors for SSI', 'breast cancer surgery']","['antibiotic prophylaxis', 'placebo', 'cefazolin (antibiotic group, n = 62) or placebo (control group, n = 62) as preoperative prophylaxis', 'Antibiotic prophylaxis']","['surgical site infection (SSI) rates', 'overall SSI rate', 'SSI rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}]","[{'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007546', 'cui_str': 'Cefazolin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",124.0,0.590906,"CONCLUSION


Antibiotic prophylaxis had no significant effect on reducing SSI rates in women without independent risk factors for SSI undergoing breast cancer surgery.","[{'ForeName': 'Rubens Murilo de Athayde', 'Initials': 'RMA', 'LastName': 'Prudencio', 'Affiliation': ""Master, Professional Master's Program in Applied Health Sciences, Universidade do Vale do Sapucaí (UNIVÁS), Pouso Alegre-MG, and Breast Cancer Unit, Hospital São Cristóvão, Sao Paulo-SP, Brazil. Conception, design, intellectual and scientific content of the study; acquisition, interpretation and analysis of data; manuscript writing; final approval.""}, {'ForeName': 'Fabíola Soares Moreira', 'Initials': 'FSM', 'LastName': 'Campos', 'Affiliation': ""Master, Professional Master's Program in Applied Health Sciences, and Hospital das Clínicas Samuel Libânio, UNIVÁS, Pouso Alegre-MG, Brazil. Conception, design, intellectual and scientific content of the study; acquisition, interpretation and analysis of data; manuscript writing; final approval.""}, {'ForeName': 'Ana Beatriz Alkmim Teixeira', 'Initials': 'ABAT', 'LastName': 'Loyola', 'Affiliation': ""PhD, Associate Professor, Professional Master's Program in Applied Health Sciences, UNIVÁS, Pouso Alegre-MG, Brazil. Conception, design, intellectual and scientific content of the study; interpretation and analysis of data; manuscript writing; critical revision; final approval.""}, {'ForeName': 'Ivanildo', 'Initials': 'I', 'LastName': 'Archangelo Junior', 'Affiliation': 'MD, Department of Breast Surgery, UNIVÁS, Pouso Alegre-MG, Brazil. Conception, design, intellectual and scientific content of the study; acquisition of data; final approval.'}, {'ForeName': 'Neil Ferreira', 'Initials': 'NF', 'LastName': 'Novo', 'Affiliation': 'PhD, Full Professor, Department of Biostatistics, UNIVÁS, Pouso Alegre-MG, Brazil. Interpretation of data, statistical analysis, critical revision, final approval.'}, {'ForeName': 'Lydia Masako', 'Initials': 'LM', 'LastName': 'Ferreira', 'Affiliation': 'PhD, Chairwoman, Head, Postgraduate Program in Translational Surgery, Division of Plastic Surgery, Universidade Federal de São Paulo (UNIFESP), Sao Paulo-SP, Brazil. Critical revision, final approval.'}, {'ForeName': 'Daniela Francescato', 'Initials': 'DF', 'LastName': 'Veiga', 'Affiliation': ""PhD, Associate Professor, Professional Master's Program in Applied Health Sciences, UNIVÁS, Pouso Alegre-MG, and Postgraduate Program in Translational Surgery, UNIFESP, Sao Paulo-SP, Brazil. Conception, design, intellectual and scientific content of the study; interpretation and analysis of data; manuscript writing; critical revision; final approval.""}]",Acta cirurgica brasileira,['10.1590/s0102-865020200090000007']
2054,33027400,Effect of a breastfeeding educational intervention: a randomized controlled trial.,"OBJECTIVE


to assess the effect of a breastfeeding educational intervention on the counseling provided to postpartum women.
METHOD


this is a randomized controlled trial including 104 postpartum women (intervention group = 52 and control group = 52) from a private hospital, whose educational intervention was based on the pragmatic theory and on the use of a soft-hard technology called Breastfeeding Educational Kit (Kit Educativo para Aleitamento Materno, KEAM). Women were followed-up for up to 60 days after childbirth. Chi-Squared Test, Fischer's Exact Test, and Generalized Estimating Equation were used, with a significance level of 5% (p-value <0.05). The analyses were performed using the Statistical Package for the Social Sciences, version 24.
RESULTS


the postpartum women in the intervention group had fewer breastfeeding difficulties and a higher percentage of exclusive breastfeeding at all time points compared with those in the control group.
CONCLUSION


the educational intervention based on active methodologies and stimulating instructional resources was effective in developing greater practical mastery among postpartum women with regard to adherence and maintenance of exclusive breastfeeding. Registry REBEC RBR - 8p9v7v.",2020,"the postpartum women in the intervention group had fewer breastfeeding difficulties and a higher percentage of exclusive breastfeeding at all time points compared with those in the control group.
","['104 postpartum women (intervention group = 52 and control group = 52) from a private hospital, whose educational intervention was based on the pragmatic theory and on the use of a']","['soft-hard technology called Breastfeeding Educational Kit (Kit Educativo para Aleitamento Materno, KEAM', 'educational intervention', 'breastfeeding educational intervention']","['exclusive breastfeeding', 'breastfeeding difficulties']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033173', 'cui_str': 'Private hospital'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C1998999', 'cui_str': 'Difficulty performing breast-feeding'}]",104.0,0.0764986,"the postpartum women in the intervention group had fewer breastfeeding difficulties and a higher percentage of exclusive breastfeeding at all time points compared with those in the control group.
","[{'ForeName': 'Erdnaxela Fernandes do Carmo', 'Initials': 'EFDC', 'LastName': 'Souza', 'Affiliation': ''}, {'ForeName': 'Alfredo Almeida', 'Initials': 'AA', 'LastName': 'Pina-Oliveira', 'Affiliation': ''}, {'ForeName': 'Antonieta Keiko Kakuda', 'Initials': 'AKK', 'LastName': 'Shimo', 'Affiliation': ''}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.3081.3335']
2055,33028261,Rationale and design of ePPOP-ID: a multicenter randomized controlled trial using an electronic-personalized program for obesity in pregnancy to improve delivery.,"BACKGROUND


Pre-pregnancy obesity and excessive gestational weight gain (GWG) are established risk factors for adverse pregnancy, delivery and birth outcomes. Pregnancy is an ideal moment for nutritional interventions in order to establish healthier lifestyle behaviors in women at high risk of obstetric and neonatal complications.
METHODS


Electronic-Personalized Program for Obesity during Pregnancy to Improve Delivery (ePPOP-ID) is an open multicenter randomized controlled trial which will assess the efficacy of an e-health web-based platform offering a personalized lifestyle program to obese pregnant women in order to reduce the rate of labor procedures and delivery interventions in comparison to standard care. A total of 860 eligible pregnant women will be recruited in 18 centers in France between 12 and 22 weeks of gestation, randomized into the intervention or the control arm and followed until 10 weeks of postpartum. The intervention is based on nutrition, eating behavior, physical activity, motivation and well-being advices in which personalization is central, as well as the use of a mobile/tablet application. Inputs includes data from the medical record of participants (medical history, anthropometric data), from the web platform (questionnaires on dietary habits, eating behavior, physical activity and motivation in both groups), and adherence to the program (time of connection for the intervention group only). Data are collected at inclusion, 32 weeks, delivery and 10 weeks postpartum. As primary outcome, we will use a composite endpoint score of obstetrical interventions during labor and delivery, defined as caesarean section and instrumental delivery (forceps and vacuum extractor). Secondary outcomes will consist of data routinely collected as part of usual antenatal and perinatal care, such as GWG, hypertension, preeclampsia, as well as fetal and neonatal outcomes including premature birth, gestational age at birth, birth weight, macrosomia, Apgar score, arterial umbilical cord pH, neonatal traumatism, hyperbilirubinemia, respiratory distress syndrome, transfer in neonatal intensive care unit, and neonatal adiposity. Post-natal outcomes will be duration of breastfeeding, maternal weight retention and child weight at postnatal visit.
DISCUSSION


The findings of the ePPOP-ID trial will help design e-health intervention program for obese women in pregnancy.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02924636 / October 5th 2016.",2020,"A total of 860 eligible pregnant women will be recruited in 18 centers in France between 12 and 22 weeks of gestation, randomized into the intervention or the control arm and followed until 10 weeks of postpartum.","['860 eligible pregnant women will be recruited in 18 centers in France between 12 and 22\u2009weeks of gestation', 'obese pregnant women', 'women at high risk of obstetric and neonatal complications', 'obese women in pregnancy']","['ePPOP-ID', 'electronic-personalized program', 'e-health web-based platform offering a personalized lifestyle program']","['consist of data routinely collected as part of usual antenatal and perinatal care, such as GWG, hypertension, preeclampsia, as well as fetal and neonatal outcomes including premature birth, gestational age at birth, birth weight, macrosomia, Apgar score, arterial umbilical cord pH, neonatal traumatism, hyperbilirubinemia, respiratory distress syndrome, transfer in neonatal intensive care unit, and neonatal adiposity', 'duration of breastfeeding, maternal weight retention and child weight at postnatal visit', 'composite endpoint score of obstetrical interventions during labor and delivery, defined as caesarean section and instrumental delivery (forceps and vacuum extractor']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0242963', 'cui_str': 'Perinatal Care'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1261135', 'cui_str': 'Postnatal visit'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0162209', 'cui_str': 'Instrumental delivery'}, {'cui': 'C0016533', 'cui_str': 'Forceps'}, {'cui': 'C1272612', 'cui_str': 'Vacuum extractor'}]",860.0,0.168622,"A total of 860 eligible pregnant women will be recruited in 18 centers in France between 12 and 22 weeks of gestation, randomized into the intervention or the control arm and followed until 10 weeks of postpartum.","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Deruelle', 'Affiliation': 'Univ. Lille, CHU Lille, EA 4489 - Environnement Périnatal et Santé, F-59000, Lille, France. pderuelle@unistra.fr.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Lelorain', 'Affiliation': 'Univ. Lille, CNRS, CHU Lille, UMR 9193 - SCALab - Cognitive and Affective Sciences, Lille, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Deghilage', 'Affiliation': 'Univ. Lille, CHU Lille, EA 4489 - Environnement Périnatal et Santé, F-59000, Lille, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Couturier', 'Affiliation': 'Univ. Lille, CHU Lille, EA 4489 - Environnement Périnatal et Santé, F-59000, Lille, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Guilbert', 'Affiliation': 'Univ. Lille, CHU Lille, EA 4489 - Environnement Périnatal et Santé, F-59000, Lille, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Berveiller', 'Affiliation': 'Department of Obstetrics and Gynecology, Poissy Saint Germain hospital, Poissy, France.'}, {'ForeName': 'Marie Victoire', 'Initials': 'MV', 'LastName': 'Sénat', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Department of Gynecology-Obstetrics, Bicêtre Hospital, University of Paris-Sud, University of Medicine Paris- Saclay Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Vayssière', 'Affiliation': 'Department of Obstetrics and Gynecology, Paule de Viguier Hospital, CHU Toulouse, Toulouse, France.'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Sentilhes', 'Affiliation': 'Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Perrotin', 'Affiliation': 'Department of Gynecology and Obstetrics, Inserm U1253 « Imaging and Brain » (iBrain). CHU Bretonneau, Tours, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Gallot', 'Affiliation': 'Pôle Femme Et Enfant, CHU Estaing, Clermont-Ferrand cedex 1, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Chauleur', 'Affiliation': 'INSERM, SAINBIOSE, U1059, Dysfonction Vasculaire et Hémostase, Université Jean-Monnet, CIC1408, F- 42055, Saint-Etienne, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Sananes', 'Affiliation': 'Pôle Gynécologie, Obstétrique et Fertilité, Hôpitaux Universitaires de Strasbourg, 67200, Strasbourg cedex, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Roth', 'Affiliation': 'Pôle Gynécologie, Obstétrique et Fertilité, Hôpitaux Universitaires de Strasbourg, 67200, Strasbourg cedex, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Luton', 'Affiliation': 'Department of Obstetrics and Gynecology, AP-HP, Bichat hospital, Paris, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Caputo', 'Affiliation': 'Department of Obstetrics and Gynecology, Lens general hospital, Lens, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lorio', 'Affiliation': 'Department of Obstetrics and Gynecology, Valenciennes general hospital, Valenciennes, France.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Chatelet', 'Affiliation': 'Department of Obstetrics and Gynecology, Béthune general hospital, Béthune, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Couster', 'Affiliation': 'Department of Obstetrics and Gynecology, Boulogne general hospital, Boulogne, France.'}, {'ForeName': 'Oumar', 'Initials': 'O', 'LastName': 'Timbely', 'Affiliation': 'Department of Obstetrics and Gynecology, Meaux general hospital, Meaux, France.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Doret-Dion', 'Affiliation': 'Department of obstetrics and gynecology surgery, Femme mere enfant university hospital, hospices civils de Lyon, Bron, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Duhamel', 'Affiliation': 'Univ. Lille, CHU Lille, EA 2694 - Santé publique : épidémiologie et qualité des soins, F-59000, Lille, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Pigeyre', 'Affiliation': 'Department of medicine, endocrinology division, Mc Master university, Hamilton, Canada.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03288-x']
2056,33032471,Effect of  Bifidobacterium infantis  NLS super strain in symptomatic coeliac disease patients on long-term gluten-free diet - an exploratory study.,"Bifidobacterium infantis  NLS super strain ( B. infantis  NLS-SS) was previously shown to alleviate gastrointestinal symptoms in newly diagnosed coeliac disease (CD) patients consuming gluten. A high proportion of patients following a gluten-free diet experiences symptoms despite dietary compliance. The role of  B. infantis  in persistently symptomatic CD patients has not been explored. The aim of the study was to evaluate the effect of  B. infantis  NLS-SS on persistent gastrointestinal symptoms in patients with CD following a long-term GFD. We conducted a randomised, cross-over, double-blind, placebo-controlled trial in symptomatic adult CD patients on a GFD for at least two years. After one-week run-in, patients were randomised to  B. infantis  NLS-SS or placebo for 3 weeks with cross-over after a 2-week wash-out period. We estimated changes (Δ) in celiac symptom index (CSI) before and after treatment. Stool samples were collected for faecal microbiota analysis (16S rRNA sequencing). Gluten immunogenic peptide (GIP) excretion in stool and urine samples was measured at each study period. Eighteen patients were enrolled; six patients were excluded due violations in protocol. For patients with the highest clinical burden, CD symptoms were lower in probiotic than in placebo treatment ( P =0.046).  B. infantis  and placebo treated groups had different microbiota profiles as assessed by beta diversity clustering. In probiotic treated groups, we observed an increase in abundance of  B. infantis . Treatment with  B. infantis  was associated with decreased abundance of  Ruminococcus  sp. and  Bifidobacterium adolescentis . GIP excretion in stools and urine was similar at each treatment period. There were no differences in adverse effects between the two groups.  B. infantis  NLS-SS improves specific CD symptoms in a subset of highly symptomatic treated patients (GFD). This is associated with a shift in stool microbiota profile. Larger studies are needed to confirm these findings. ClinicalTrials.gov: NCT03271138.",2020,Treatment with  B. infantis  was associated with decreased abundance of  Ruminococcus  sp. and  Bifidobacterium adolescentis .,"['symptomatic coeliac disease patients on long-term gluten-free diet - an exploratory study', 'Eighteen patients were enrolled; six patients were excluded due violations in protocol', 'persistently symptomatic CD patients', 'symptomatic adult CD patients on a GFD for at least two years', 'patients with CD following a long-term GFD', 'newly diagnosed coeliac disease (CD) patients consuming gluten']","['Bifidobacterium infantis  NLS super strain ( B. infantis  NLS-SS', 'NLS-SS or placebo', 'B. infantis  NLS-SS', 'placebo', 'Bifidobacterium infantis  NLS super strain']","['CD symptoms', 'GIP excretion in stools and urine', 'adverse effects', 'abundance of  B. infantis ', 'microbiota profiles', 'celiac symptom index (CSI', 'specific CD symptoms', 'Gluten immunogenic peptide (GIP) excretion in stool and urine samples']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1851112', 'cui_str': 'Gingival fibromatosis with progressive deafness syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}]","[{'cui': 'C0314976', 'cui_str': 'Bifidobacterium Infantis'}, {'cui': 'C0265218', 'cui_str': 'Neu-Laxova syndrome'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3494227', 'cui_str': 'Spinocranial Irradiation'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}]",18.0,0.209674,Treatment with  B. infantis  was associated with decreased abundance of  Ruminococcus  sp. and  Bifidobacterium adolescentis .,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Smecuol', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Constante', 'Affiliation': 'Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON L8S 4L8, Canada.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Temprano', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Costa', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Moreno', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Pinto-Sanchez', 'Affiliation': 'Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON L8S 4L8, Canada.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Vázquez', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Stefanolo', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Gonzalez', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': ""D'Adamo"", 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD 21201, USA.'}, {'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Niveloni', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mauriño', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}, {'ForeName': 'E F', 'Initials': 'EF', 'LastName': 'Verdu', 'Affiliation': 'Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON L8S 4L8, Canada.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Bai', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}]",Beneficial microbes,['10.3920/BM2020.0016']
2057,33032474,Clinical evaluation of the synbiotic Prodefen Plus® in the prevention of the antibiotic-associated diarrhoea in subjects requiring antibiotic treatment.,"Prodefen® is a dietary food supplement formulated as a synbiotic that has shown additional benefit to the standard supportive therapy in the management of acute viral diarrhoea in children. There is scarce evidence of this synbiotic in adults. The objective of this randomised double blind placebo-controlled clinical trial was to evaluate the efficacy and safety of Prodefen Plus® in the prevention of antibiotic-associated diarrhoea (AAD) in an adult population requiring either antibiotic treatment for an oral infection or antibiotic prophylaxis for a dental surgical procedure in a dental consultation. 151 subjects were randomised to the active (synbiotic) or control arm (placebo) for 14 days. There was a significantly higher reduction in the AAD incidence, and an improvement in the stool consistency in the active group. A higher reduction in both the frequency and duration of the diarrhoea episodes in the active group was also observed, as it was an improved perception of the diarrhoea severity. Overall, the study medication was well tolerated. In conclusion, results from this study confirm the beneficial effect of the synbiotic administered as adjuvant therapy in preventing the antibiotic-associated diarrhoea.",2020,"There was a significantly higher reduction in the AAD incidence, and an improvement in the stool consistency in the active group.","['adults', '151 subjects', 'acute viral diarrhoea in children', 'subjects requiring antibiotic treatment', 'adult population requiring either antibiotic treatment for an oral infection or antibiotic prophylaxis for a dental surgical procedure in a dental consultation']","['synbiotic', 'active (synbiotic) or control arm (placebo', 'placebo', 'Prodefen Plus®', 'synbiotic Prodefen Plus®']","['AAD incidence', 'efficacy and safety', 'diarrhoea severity', 'tolerated', 'stool consistency', 'frequency and duration of the diarrhoea episodes', 'antibiotic-associated diarrhoea (AAD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0152517', 'cui_str': 'Viral gastroenteritis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0555971', 'cui_str': 'Oral infection'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0204324', 'cui_str': 'Dental surgical procedure'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0578159', 'cui_str': 'Antibiotic-associated diarrhea'}]",151.0,0.159538,"There was a significantly higher reduction in the AAD incidence, and an improvement in the stool consistency in the active group.","[{'ForeName': 'C Barreiro', 'Initials': 'CB', 'LastName': 'Guridi', 'Affiliation': 'Clínica Dental Dra. Coro Guridi Rodríguez, Av. Francisco de Goya 16, 50006 Zaragoza, Spain.'}, {'ForeName': 'A Romeo', 'Initials': 'AR', 'LastName': 'Serena', 'Affiliation': 'Clínica Dental Dra Marina Tarrío, Paseo de Calanda 1, 50010 Zaragoza, Spain.'}, {'ForeName': 'S Gallego', 'Initials': 'SG', 'LastName': 'Cabrera', 'Affiliation': 'Clínica Dental Gallego, Avinguda de Pérez Galdós 2, 46007 València, Spain.'}, {'ForeName': 'I Alaman', 'Initials': 'IA', 'LastName': 'Fernández', 'Affiliation': 'Maxiloimplant Clínica Dental, Calle de Guareña, 5, 28044 Madrid, Spain.'}, {'ForeName': 'C Royo', 'Initials': 'CR', 'LastName': 'Hernández', 'Affiliation': 'Clínica Dental Royo, Av. Oscar Espla 21, 03007 Alacant, Spain.'}, {'ForeName': 'B Martín', 'Initials': 'BM', 'LastName': 'Vivanco', 'Affiliation': 'Clínica Dental Beatriz Martín Vivanco, C/ Ana Albi 19 bajo, 28025 Madrid, Spain.'}, {'ForeName': 'M Cruz', 'Initials': 'MC', 'LastName': 'Melguizo', 'Affiliation': 'Clínica Dental Sonrisas, C. de la Princesa 90, piso 2°, 2ª, 28008 Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Suárez-Almarza', 'Affiliation': 'ITF Research Pharma S.L.U., Grupo Italfarmaco, Calle s San Rafael 3, 28108 Alcobendas, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nieto-Magro', 'Affiliation': 'ITF Research Pharma S.L.U., Grupo Italfarmaco, Calle s San Rafael 3, 28108 Alcobendas, Spain.'}]",Beneficial microbes,['10.3920/BM2020.0062']
2058,33034900,Local cooling for relieving pain from perineal trauma sustained during childbirth.,"BACKGROUND


Perineal trauma is common during childbirth and may be painful. Contemporary maternity practice includes offering women numerous forms of pain relief, including the local application of cooling treatments. This Cochrane Review is an update of a review last updated in 2012.
OBJECTIVES


To evaluate the effectiveness of localised cooling treatments compared with no treatment, placebo, or other cooling treatments applied to the perineum for pain relief following perineal trauma sustained during childbirth.
SEARCH METHODS


We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (7 October 2019) and reference lists of retrieved studies.
SELECTION CRITERIA


Published and unpublished randomised and quasi-randomised trials (RCTs) that compared a localised cooling treatment applied to the perineum with no treatment, placebo, or another cooling treatment applied to relieve pain related to perineal trauma sustained during childbirth.
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of included studies. Data were double checked for accuracy. The certainty of the evidence was assessed using the GRADE approach.
MAIN RESULTS


We included 10 RCTs that enrolled 1233 women randomised to the use of one cooling treatment (ice, cold gel pad, cooling plus compression, cooling plus compression plus (being) horizontal) compared with another cooling treatment, no treatment, or placebo (water pack, compression). The included trials were at low or uncertain risk of bias overall, with the exception that the inability to blind participants and personnel to group allocation meant that we rated all trials at unclear or high risk for this domain. We undertook a number of comparisons to evaluate the different treatments. Cooling treatment (ice pack or cold gel pad) versus no treatment There was limited very low-certainty evidence that cooling treatment may reduce women's self-reported perineal pain within four to six hours (mean difference (MD) -4.46, 95% confidence interval (CI) -5.07 to -3.85 on a 10-point scale; 1 study, 100 participants) or between 24 and 48 hours of giving birth (risk ratio (RR) 0.73, 95% CI 0.57 to 0.94; 1 study, 316 participants). The evidence is very uncertain about the various measures of wound healing, for example, wound edges gaping when inspected five days after giving birth (RR 2.56, 95% CI 0.58 to 11.33; 1 study, 315 participants). Women generally rated their satisfaction with perineal care similarly following cooling or no treatment. The potential exception was that there may be a trivially lower mean difference of -0.1 on a five-point scale of psychospiritual comfort with cooling treatment, that is unlikely to be of clinical importance. Cooling treatment (cold gel pad) + compression versus placebo (gel pad + compression) There was limited low-certainty evidence that there may be a trivial MD of -0.43 in pain on a 10-point scale at 24 to 48 hours after giving birth (95% CI -0.73 to -0.13; 1 study, 250 participants) when a cooling treatment plus compression from a well-secured perineal pad was compared with the placebo. Levels of perineal oedema may be similar for the two groups (low-certainty evidence) and perineal bruising was not observed. There was low-certainty evidence that women may rate their satisfaction as being slightly higher with perineal care in the cold gel pad and compression group (MD 0.88, 95% CI 0.38 to 1.38; 1 trial, 250 participants). Cooling treatment (ice pack) versus placebo (water pack) One study reported that no women reported pain after using an ice pack or a water pack when asked within 24 hours of giving birth. There was low-certainty evidence that oedema may be similar for the two groups when assessed at four to six hours (RR 0.96, 95% CI 0.50 to 1.86; 1 study, 63 participants) or within 24 hours of giving birth (RR 0.36, 95% CI 0.08 to 1.59). No women were observed to have perineal bruising at these times. The trialists reported that no women in either group experienced any adverse effects on wound healing. There was very low-certainty evidence that women may rate their views and experiences with the treatments similarly (for example, satisfied with treatment: RR 0.91, 95% CI 0.77 to 1.08; 63 participants). Cooling treatment (ice pack) versus cooling treatment (cold gel pad) The evidence is very uncertain about the effects of using ice packs or cold gel pads on women's self-rated perineal pain, on perineal bruising, or on perineal oedema at four to six hours or within 24 hours of giving birth. Perineal oedema may persist 24 to 48 hours after giving birth in women using the ice packs (RR 1.69, 95% CI 1.03 to 2.7; 2 trials, 264 participants; very low-certainty). The risk of gaping wound edges five days after giving birth may be decreased in women who had used ice packs (RR 0.22, 95% CI 0.05 to 1.01; 215 participants; very low-certainty). However, this did not appear to persist to day 10 (RR 3.06, 95% CI 0.63 to 14.81; 214 participants). Women may rate their opinion of treatment less favourably following the use of ice packs five days after giving birth (RR 0.33, 95% CI 0.17 to 0.68; 1 study, 49 participants) and when assessed on day 10 (RR 0.82, 95% CI 0.73 to 0.92; 1 study, 208 participants), both very low-certainty.
AUTHORS' CONCLUSIONS


There is limited very low-certainty evidence that may support the use of cooling treatments, in the form or ice packs or cold gel pads, for the relief of perineal pain in the first two days following childbirth. It is likely that concurrent use of several treatments is required to adequately address this issue, including prescription and non-prescription analgesia. Studies included in this review involved the use of cooling treatments for 10 to 20 minutes, and although no adverse effects were noted, these findings came from studies of relatively small numbers of women, or were not reported at all. The continued lack of high-certainty evidence of the benefits of cooling treatments should be viewed with caution, and further well-designed trials should be conducted.",2020,"To evaluate the effectiveness of localised cooling treatments compared with no treatment, placebo, or other cooling treatments applied to the perineum for pain relief following perineal trauma sustained during childbirth.
","['perineal trauma sustained during childbirth', '10 RCTs that enrolled 1233 women']","['Cooling treatment (ice pack) versus cooling treatment (cold gel pad', 'ice packs or cold gel pads', 'placebo', 'Cooling treatment (ice pack or cold gel pad', 'Local cooling', 'cooling treatment (ice, cold gel pad, cooling plus compression, cooling plus compression plus (being) horizontal) compared with another cooling treatment, no treatment, or placebo (water pack, compression', 'Cooling treatment (ice pack) versus placebo (water pack', 'Cooling treatment (cold gel pad) + compression versus placebo (gel pad + compression']","['adverse effects on wound healing', 'Perineal oedema', 'perineal pain', 'perineal bruising', 'Levels of perineal oedema', ""women's self-rated perineal pain, on perineal bruising, or on perineal oedema"", 'giving birth (risk ratio (RR', 'pain']","[{'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0181264', 'cui_str': 'Ice bag'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0235641', 'cui_str': 'Pain in female perineum'}, {'cui': 'C0009938', 'cui_str': 'Contusion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",250.0,0.513131,"To evaluate the effectiveness of localised cooling treatments compared with no treatment, placebo, or other cooling treatments applied to the perineum for pain relief following perineal trauma sustained during childbirth.
","[{'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'East', 'Affiliation': 'School of Nursing and Midwifery, La Trobe University/Mercy Hospital for Women, Bundoora, Australia.'}, {'ForeName': 'Emma Df', 'Initials': 'ED', 'LastName': 'Dorward', 'Affiliation': 'Glen Iris, Australia.'}, {'ForeName': 'Rhiannon E', 'Initials': 'RE', 'LastName': 'Whale', 'Affiliation': 'Melbourne, Australia.'}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Antenatal/Postnatal Ward, Mercy Hospital for Women, Heidelberg, Australia.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD006304.pub4']
2059,33037200,Pragmatic trial on inhaled corticosteroid withdrawal in patients with COPD in general practice.,"The therapeutic value of inhaled corticosteroids (ICSs) for COPD is limited. In published RCTs, ICS could be withdrawn in COPD patients without increasing exacerbation risk when bronchodilator treatment is optimized. Here we report on the feasibility and risks of ICS withdrawal in Dutch general practice for COPD patients without an indication for ICSs. In our pragmatic trial, general practitioners decided autonomously which of their COPD patients on ICS treatment could stop this, how this was done, and whether additional bronchodilator therapy was needed. We recruited 62 COPD patients (58 analysed) who were eligible for ICS withdrawal in 79 practices. In 32 patients (55.2%, 95% CI: 42.5-67.3%) ICS was withdrawn successfully, 19 (32.8%, 95% CI: 22.1-45.6%) restarted ICS treatment within six months, 12 patients (20.7%, 95% CI: 12.3-32.8%) had a moderate exacerbation, and one patient had a severe exacerbation. ICS withdrawal was successful in just over half of the patients with COPD without an indication for ICS.",2020,"ICS was withdrawn successfully, 19 (32.8%, 95% CI: 22.1-45.6%) restarted ICS treatment within six months, 12 patients (20.7%, 95% CI: 12.3-32.8%) had a moderate exacerbation, and one patient had a severe exacerbation.","['62 COPD patients (58 analysed) who were eligible for ICS withdrawal in 79 practices', 'Dutch general practice for COPD patients without an indication for ICSs', 'patients with COPD in general practice']",['inhaled corticosteroids (ICSs'],"['ICS', 'exacerbation risk', 'severe exacerbation']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",62.0,0.152709,"ICS was withdrawn successfully, 19 (32.8%, 95% CI: 22.1-45.6%) restarted ICS treatment within six months, 12 patients (20.7%, 95% CI: 12.3-32.8%) had a moderate exacerbation, and one patient had a severe exacerbation.","[{'ForeName': 'Lisette', 'Initials': 'L', 'LastName': 'van den Bemt', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands. Lisette.vandenBemt@radboudumc.nl.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'van den Nieuwenhof', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rutjes', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'van der Meer', 'Affiliation': 'Budel Medical Centre, Budel, The Netherlands.'}, {'ForeName': 'Gerben', 'Initials': 'G', 'LastName': 'Stege', 'Affiliation': 'Department of Pulmonology, St. Anna Hospital, Geldrop, The Netherlands.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Wensing', 'Affiliation': 'Department of General Practice and Health Services Research, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Teichert', 'Affiliation': 'Department of Clinical Pharmacy and Toxicology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Tjard', 'Initials': 'T', 'LastName': 'Schermer', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.'}]",NPJ primary care respiratory medicine,['10.1038/s41533-020-00198-5']
2060,33037255,Effect of warming eyelids on tear film stability and quality of life in visual display terminal users: a randomized controlled trial.,"We aimed to evaluate the effect of warming eyelids on tear-film stability and quality of life (QoL) in video display terminal (VDT) users. A prospective study was conducted and 45 volunteers with ocular symptoms and tear-film instability associated with VDT use were randomly allocated into the study (n = 22) or control groups (n = 23). Subjects in the study group used eyelid warming steamer (EWS) for 2 weeks and tear fluorescein breakup time (TBUT) after single and 2-week EWS treatment, Schirmer I test, ocular surface staining scores, meibomian gland assessment, severity of dry eye disease (DED) and QoL scores after 2-week EWS treatment were analysed. The TBUT improved after both single and 2-week EWS treatment (P = 0.023 and 0.027, respectively) in the study group. The ocular surface staining scores were significantly decreased only in the study group (P = 0.038). About 60% DED patients in the study group shifted towards non-DED and the pattern of distribution was significantly different compared to baseline (P < 0.001). The QoL scores significantly improved in the study group (P = 0.002) with a negative correlation with TBUT. In conclusion, in VDT users with short TBUT, eyelid warming steamer is effective in improving tear-film stability and QoL.",2020,The QoL scores significantly improved in the study group (P = 0.002) with a negative correlation with TBUT.,"['visual display terminal users', '45 volunteers with ocular symptoms and tear-film instability associated with VDT use']",['warming eyelids'],"['tear-film stability and quality of life (QoL', 'ocular surface staining scores', 'non-DED', 'tear film stability and quality of life', 'QoL scores', 'Schirmer I test, ocular surface staining scores, meibomian gland assessment, severity of dry eye disease (DED) and QoL scores', 'eyelid warming steamer (EWS', 'tear-film stability and QoL', 'tear fluorescein breakup time (TBUT']","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009615', 'cui_str': 'Computer terminal'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0015426', 'cui_str': 'Eyelid structure'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C1301514', 'cui_str': 'Schirmer I test'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0016314', 'cui_str': 'Fluoresceins'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",45.0,0.025316,The QoL scores significantly improved in the study group (P = 0.002) with a negative correlation with TBUT.,"[{'ForeName': 'Chi-Chin', 'Initials': 'CC', 'LastName': 'Sun', 'Affiliation': 'Department of Ophthalmology, Chang Gung Memorial Hospital, Keelung, Taiwan.'}, {'ForeName': 'Chia-Yi', 'Initials': 'CY', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, Show Chwan Memorial Hospital, Changhua, Taiwan.'}, {'ForeName': 'Yih-Shiou', 'Initials': 'YS', 'LastName': 'Hwang', 'Affiliation': 'Department of Medicine, School of Medicine, Chang Gung University, Taoyüan, Taiwan.'}, {'ForeName': 'Igaki', 'Initials': 'I', 'LastName': 'Michihito', 'Affiliation': 'Personal Health Care Products Research Laboratories, Kao Corporation, Sumida-ku, Tokyo, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Tagami', 'Affiliation': 'Personal Health Care Products Research Laboratories, Kao Corporation, Sumida-ku, Tokyo, Japan.'}, {'ForeName': 'Ching-Hsi', 'Initials': 'CH', 'LastName': 'Hsiao', 'Affiliation': 'Department of Medicine, School of Medicine, Chang Gung University, Taoyüan, Taiwan. hsiao.chinghsi@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-73779-6']
2061,33037261,Altered metabolomic profiling of overweight and obese adolescents after combined training is associated with reduced insulin resistance.,"Exercise training and a healthy diet are the main non-pharmacological strategies for treating chronic conditions, such as obesity and insulin resistance (IR), in adolescents. However, the isolated metabolic changes caused by exercise training without dietary intervention have not yet been established. We investigated how combined training (CT) without dietary intervention altered the concentrations of serum metabolites, biochemical, anthropometric and functional parameters in overweight and obese adolescents. Thirty-seven adolescents (14.6 ± 1.05 years), of both sexes, were randomly assigned to the control group (CG, n = 19) or the training group (TG, n = 18). The CT was composed by resistance training and aerobic training performed in the same session (~ 60 min), three times a week, for 12 weeks. All assessments were performed pre and post-intervention. Metabolomics analyses were conducted using nuclear magnetic resonance spectroscopy ( 1 H NMR) in a 600 MHz spectrometer. There was a decrease in body weight (BW), body mass index (BMI), waist circumference (WC), % body fat (%BF), fasting glucose, insulin levels, and insulin resistance (IR), by HOMA-IR, in the TG. An increase in fat-free mass (FFM) was also observed in the CG. The metabolic changes were given mainly by changes in the levels of metabolites 2-oxoisocaproate (↓TG), 3-hydroxyisobutyrate (↑CG and ↓TG), glucose (↓TG), glutamine (↓CG and ↑TG) and pyruvate (↓TG). These findings demonstrate the positive effects of CT program without dietary intervention on metabolomic profile, body composition, biochemical markers, and glucose metabolism in overweight and obese adolescents.",2020,"There was a decrease in body weight (BW), body mass index (BMI), waist circumference (WC), % body fat (%BF), fasting glucose, insulin levels, and insulin resistance (IR), by HOMA-IR, in the TG.","['Thirty-seven adolescents (14.6\u2009±\u20091.05\xa0years), of both sexes', 'overweight and obese adolescents']","['CT program without dietary intervention', 'Exercise training and a healthy diet', 'exercise training without dietary intervention', 'combined training (CT) without dietary intervention']","['levels of metabolites 2-oxoisocaproate (↓TG), 3-hydroxyisobutyrate (↑CG and ↓TG), glucose (↓TG), glutamine (↓CG and ↑TG) and pyruvate (↓TG', 'concentrations of serum metabolites, biochemical, anthropometric and functional parameters', 'fat-free mass (FFM', 'body weight (BW), body mass index (BMI), waist circumference (WC), % body fat (%BF), fasting glucose, insulin levels, and insulin resistance (IR), by HOMA-IR, in the TG', 'metabolomic profile, body composition, biochemical markers, and glucose metabolism']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4068754', 'cui_str': '1.05'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0368576', 'cui_str': '2-oxoisocaproate'}, {'cui': 'C0945804', 'cui_str': '3-hydroxyisobutyrate'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0034354', 'cui_str': 'Pyruvates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.0139828,"There was a decrease in body weight (BW), body mass index (BMI), waist circumference (WC), % body fat (%BF), fasting glucose, insulin levels, and insulin resistance (IR), by HOMA-IR, in the TG.","[{'ForeName': 'Renata G', 'Initials': 'RG', 'LastName': 'Duft', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil. renataduft@gmail.com.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Castro', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Ivan L P', 'Initials': 'ILP', 'LastName': 'Bonfante', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Wendell A', 'Initials': 'WA', 'LastName': 'Lopes', 'Affiliation': 'Department of Physical Education, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Larissa R', 'Initials': 'LR', 'LastName': 'da Silva', 'Affiliation': 'Department of Physical Education, University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Mara P T', 'Initials': 'MPT', 'LastName': 'Chacon-Mikahil', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Neiva', 'Initials': 'N', 'LastName': 'Leite', 'Affiliation': 'Department of Physical Education, University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Cláudia R', 'Initials': 'CR', 'LastName': 'Cavaglieri', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil. cavaglieri@fef.unicamp.br.'}]",Scientific reports,['10.1038/s41598-020-73943-y']
2062,33037320,Multidimensional analyses reveal modulation of adaptive and innate immune subsets by tuberculosis vaccines.,"We characterize the breadth, function and phenotype of innate and adaptive cellular responses in a prevention of Mycobacterium tuberculosis infection trial. Responses are measured by whole blood intracellular cytokine staining at baseline and 70 days after vaccination with H4:IC31 (subunit vaccine containing Ag85B and TB10.4), Bacille Calmette-Guerin (BCG, a live attenuated vaccine) or placebo (n = ~30 per group). H4:IC31 vaccination induces Ag85B and TB10.4-specific CD4 T cells, and an unexpected NKT like  subset, that expresses IFN-γ, TNF and/or IL-2. BCG revaccination increases frequencies of CD4 T cell subsets that either express Th1 cytokines or IL-22, and modestly increases IFNγ-producing NK cells. In vitro BCG re-stimulation also triggers responses by donor-unrestricted T cells, which may contribute to host responses against mycobacteria. BCG, which demonstrated efficacy against sustained Mycobacterium tuberculosis infection, modulates multiple immune cell subsets, in particular conventional Th1 and Th22 cells, which should be investigated in discovery studies of correlates of protection.",2020,"BCG revaccination increases frequencies of CD4 T cell subsets that either express Th1 cytokines or IL-22, and modestly increases IFNγ-producing NK cells.",[],"['BCG', 'H4:IC31 vaccination', 'H4:IC31 (subunit vaccine containing Ag85B and TB10.4), Bacille Calmette-Guerin (BCG, a live attenuated vaccine) or placebo']","['Ag85B and TB10.4-specific CD4 T cells', 'IFNγ-producing NK cells', 'blood intracellular cytokine staining']",[],"[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0887892', 'cui_str': 'Vaccines, Subunit'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0038128', 'cui_str': 'Stain'}]",,0.143423,"BCG revaccination increases frequencies of CD4 T cell subsets that either express Th1 cytokines or IL-22, and modestly increases IFNγ-producing NK cells.","[{'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Rozot', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa. virginie.rozot@uct.ac.za.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Nemes', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Hennie', 'Initials': 'H', 'LastName': 'Geldenhuys', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Munyaradzi', 'Initials': 'M', 'LastName': 'Musvosvi', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Toefy', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Rantangee', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lebohang', 'Initials': 'L', 'LastName': 'Makhethe', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mzwandile', 'Initials': 'M', 'LastName': 'Erasmus', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bilek', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Simbarashe', 'Initials': 'S', 'LastName': 'Mabwe', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Finak', 'Affiliation': 'Fred Hutchinson Cancer Research Center (FHCRC), Seattle, WA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Fulp', 'Affiliation': 'Fred Hutchinson Cancer Research Center (FHCRC), Seattle, WA, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Ginsberg', 'Affiliation': 'AERAS, Rockville, MD, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hokey', 'Affiliation': 'AERAS, Rockville, MD, USA.'}, {'ForeName': 'Muki', 'Initials': 'M', 'LastName': 'Shey', 'Affiliation': 'Aeras South Africa Endpoint Assay Laboratory, Cape Town, South Africa.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Gurunathan', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'DiazGranados', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hatherill', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Scriba', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa. thomas.scriba@uct.ac.za.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Communications biology,['10.1038/s42003-020-01288-3']
2063,33041071,Near-infrared fluorescence imaging compared to standard sentinel lymph node detection with blue dye in patients with vulvar cancer - a randomized controlled trial.,"OBJECTIVE


The aim of this study was to assess the superiority of ICG- 99m Tc-nanocolloid for the intraoperative visual detection of sentinel lymph nodes (SLNs) in vulvar squamous cell carcinoma (VSCC) patients compared to standard SLN detection using  99m Tc-nanocolloid with blue dye.
METHODS


In this multicenter, randomized controlled trial, VSCC patients underwent either the standard SLN procedure or with the hybrid tracer ICG- 99m Tc-nanocolloid. The primary endpoint was the percentage of fluorescent SLNs compared to blue SLNs. Secondary endpoints were successful SLN procedures, surgical outcomes and postoperative complications.
RESULTS


Forty-eight patients were randomized to the standard (n = 24) or fluorescence imaging group (n = 24) using ICG- 99m Tc-nanocolloid. The percentage of blue SLNs was 65.3% compared to 92.5% fluorescent SLNs (p < 0.001). A successful SLN procedure was obtained in 92.1% of the groins in the standard group and 97.2% of the groins in the fluorescence imaging group (p = 0.33). Groups did not differ in surgical outcome, although more short-term postoperative complications were documented in the standard group (p = 0.041).
CONCLUSIONS


Intraoperative visual detection of SLNs in patients with VSCC using ICG- 99m Tc-nanocolloid was superior compared to  99m Tc-nanocolloid and blue dye. The rate of successful SLN procedures between both groups was not significantly different. Fluorescence imaging has potential to be used routinely in the SLN procedure in VSCC patients to facilitate the search by direct visualization.
CLINICAL TRIAL REGISTRATION


Netherlands Trial Register (Trial ID NL7443).",2020,The rate of successful SLN procedures between both groups was not significantly different.,"['patients with vulvar cancer', 'Forty-eight patients', 'vulvar squamous cell carcinoma (VSCC) patients']","['standard SLN detection using  99m Tc-nanocolloid with blue dye', 'VSCC', 'ICG- 99m Tc-nanocolloid', 'standard SLN procedure or with the hybrid tracer ICG- 99m Tc-nanocolloid', 'fluorescence imaging']","['percentage of fluorescent SLNs', 'short-term postoperative complications', 'successful SLN procedures, surgical outcomes and postoperative complications', 'percentage of blue SLNs', 'rate of successful SLN procedures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0375071', 'cui_str': 'Malignant tumor of vulva'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0280856', 'cui_str': 'Squamous cell carcinoma of vulva'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0303611', 'cui_str': 'Technetium 99m'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0430876', 'cui_str': 'Ophthalmic fluorescence imaging'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}]",48.0,0.105615,The rate of successful SLN procedures between both groups was not significantly different.,"[{'ForeName': 'Marion M', 'Initials': 'MM', 'LastName': 'Deken', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Helena C', 'Initials': 'HC', 'LastName': 'van Doorn', 'Affiliation': 'Department of Gynecologic Oncology, Erasmus MC Cancer Institute, Erasmus University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Verver', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Erasmus University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Leonora S F', 'Initials': 'LSF', 'LastName': 'Boogerd', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Kim S', 'Initials': 'KS', 'LastName': 'de Valk', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Daphne D D', 'Initials': 'DDD', 'LastName': 'Rietbergen', 'Affiliation': 'Department of Radiology, Section Nuclear Medicine, Leiden University Medical Center, Leiden, the Netherlands; Interventional Molecular Imaging Laboratory, Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Mariëtte I E', 'Initials': 'MIE', 'LastName': 'van Poelgeest', 'Affiliation': 'Department of Gynecology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Cor D', 'Initials': 'CD', 'LastName': 'de Kroon', 'Affiliation': 'Department of Gynecology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Jogchum J', 'Initials': 'JJ', 'LastName': 'Beltman', 'Affiliation': 'Department of Gynecology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Fijs W B', 'Initials': 'FWB', 'LastName': 'van Leeuwen', 'Affiliation': 'Interventional Molecular Imaging Laboratory, Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Jeffrey P B M', 'Initials': 'JPBM', 'LastName': 'Braak', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Lioe-Fee', 'Initials': 'LF', 'LastName': 'de Geus-Oei', 'Affiliation': 'Department of Radiology, Section Nuclear Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Cock J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Burggraaf', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Vahrmeijer', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Katja N', 'Initials': 'KN', 'LastName': 'Gaarenstroom', 'Affiliation': 'Department of Gynecology, Leiden University Medical Center, Leiden, the Netherlands. Electronic address: K.N.Gaarenstroom@lumc.nl.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.09.044']
2064,33041091,"Omega-3 polyunsaturated fatty acid supplementation improves lipid metabolism and endothelial function by providing a beneficial eicosanoid-pattern in patients with acute myocardial infarction: A randomized, controlled trial.","BACKGROUND & AIMS


Omega-3 polyunsaturated fatty acid (ω-3 PUFA) have been reported to have beneficial cardiovascular effects, but its mechanism of protection against acute myocardial infarction (AMI) who are under guideline-based therapy is not fully understood. Here, we used a metabolomic approach to systematically analyze the eicosanoid metabolites induced by ω-3 PUFA supplementation and investigated the underlying mechanisms.
METHODS


Participants with AMI after successful percutaneous coronary intervention were randomized to 3 months of 2 g daily ω-3 PUFA and guideline-adjusted therapy (n = 30, ω-3 therapy) or guideline-adjusted therapy alone (n = 30, Usual therapy). Functional PUFA-derived eicosanoids in plasma were profiled by metabolomics. Clinical and laboratory tests were obtained before and 3 months after baseline and after the study therapy.
RESULTS


By intent-to-treat analysis, the content of 11-HDoHE, 20-HDoHE and 16,17-EDP and that of epoxyeicosatetraenoic acids (EEQs), derived from docosahexaenoic acid and eicosapentaenoic acid, respectively, were significantly higher with ω-3 group than Usual therapy, whereas that of prostaglandin J2 (PGJ2) and leukotriene B4, derived from arachidonic acid, was significantly decreased. As compared with Usual therapy, ω-3 PUFA therapy significantly reduced levels of triglycerides (-6.3%, P < 0.05), apolipoprotein B (-4.9%, P < 0.05) and lipoprotein(a) (-37.0%, P < 0.05) and increased nitric oxide level (62.2%, P < 0.05). In addition, the levels of these variables were positively correlated with change in 16,17-EDP and EEQs content but negatively with change in PGJ2 content.
CONCLUSIONS


ω-3 PUFA supplementation may improve lipid metabolism and endothelial function possibly by affecting eicosanoid metabolic status at a systemic level during convalescent healing after AMI.
CLINICAL TRIAL REGISTRATION


URL: http://www.chictr.org.cn. Unique identifier: ChiCTR1900025859.",2020,"As compared with Usual therapy, ω-3 PUFA therapy significantly reduced levels of triglycerides (-6.3%, P < 0.05), apolipoprotein B (-4.9%, P ","['Participants with AMI after successful percutaneous coronary intervention', 'patients with acute myocardial infarction']","['ω-3 PUFA supplementation', 'ω-3 PUFA and guideline-adjusted therapy (n\xa0=\xa030, ω-3 therapy) or guideline-adjusted therapy alone ', 'Omega-3 polyunsaturated fatty acid (ω-3 PUFA', 'Omega-3 polyunsaturated fatty acid supplementation', 'Usual therapy, ω-3 PUFA therapy']","['nitric oxide level', 'levels of triglycerides', 'content of 11-HDoHE, 20-HDoHE and 16,17-EDP and that of epoxyeicosatetraenoic acids (EEQs', 'lipoprotein(a', 'lipid metabolism and endothelial function', 'apolipoprotein B', '16,17-EDP and EEQs content']","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}]",,0.152564,"As compared with Usual therapy, ω-3 PUFA therapy significantly reduced levels of triglycerides (-6.3%, P < 0.05), apolipoprotein B (-4.9%, P ","[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Yuan', 'Affiliation': 'Tianjin Key Laboratory of Metabolic Diseases, Key Laboratory of Immune Microenvironment and Disease-Ministry of Education, Department of Physiology and Pathophysiology, Collaborative Innovation Center of Tianjin for Medical Epigenetics, Tianjin Medical University, QiXiangTai Road 23, Tianjin 300070, China; Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, PingJiang Road 22, Tianjin, 300211, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, PingJiang Road 22, Tianjin, 300211, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Hua', 'Affiliation': 'Tianjin Key Laboratory of Metabolic Diseases, Key Laboratory of Immune Microenvironment and Disease-Ministry of Education, Department of Physiology and Pathophysiology, Collaborative Innovation Center of Tianjin for Medical Epigenetics, Tianjin Medical University, QiXiangTai Road 23, Tianjin 300070, China.'}, {'ForeName': 'Xiang-Li', 'Initials': 'XL', 'LastName': 'Liu', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, PingJiang Road 22, Tianjin, 300211, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, PingJiang Road 22, Tianjin, 300211, China.'}, {'ForeName': 'Ru-Yu', 'Initials': 'RY', 'LastName': 'Yuan', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, PingJiang Road 22, Tianjin, 300211, China.'}, {'ForeName': 'Guang-Ping', 'Initials': 'GP', 'LastName': 'Li', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, PingJiang Road 22, Tianjin, 300211, China. Electronic address: tic_tjcardiol@126.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Tianjin Key Laboratory of Metabolic Diseases, Key Laboratory of Immune Microenvironment and Disease-Ministry of Education, Department of Physiology and Pathophysiology, Collaborative Innovation Center of Tianjin for Medical Epigenetics, Tianjin Medical University, QiXiangTai Road 23, Tianjin 300070, China. Electronic address: zhuyi@tmu.edu.cn.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Tianjin Key Laboratory of Metabolic Diseases, Key Laboratory of Immune Microenvironment and Disease-Ministry of Education, Department of Physiology and Pathophysiology, Collaborative Innovation Center of Tianjin for Medical Epigenetics, Tianjin Medical University, QiXiangTai Road 23, Tianjin 300070, China. Electronic address: xuzhang@tmu.edu.cn.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.05.034']
2065,33041092,Older frail prehabilitated patients who cannot attain a 400 m 6-min walking distance before colorectal surgery suffer more postoperative complications.,"INTRODUCTION


Recent efforts to prehabilitate intermediately frail and frail (Fried frailty criteria ≥2) elective colorectal cancer patients did not influence clinical nor functional outcomes. The objective of this secondary analysis was to describe the subset of intermediately frail and frail prehabilitated patients who could not attain a minimum 400 m (a prognostic cut-point used in other patient populations) 6-min walking distance (6MWD) before elective surgery.
MATERIALS AND METHODS


Secondary analysis of a randomized controlled trial. Patients participated in multimodal prehabilitation at home and in-hospital for approximately four weeks before colorectal surgery. Primary outcome was incidence of postoperative complications within 30 days of hospital discharge.
RESULTS


Sixty percent of the patients who participated in prehabilitation did not reach a minimum walking distance of 400 m in 6 min before surgery. Compared to the group that attained ≥400 m 6MWD (n = 19), the <400 m group (n = 28) were older, had higher percent body fat, lower physical function, lower self-reported physical activity, higher American Society of Anesthesiologists (ASA) classification, and twice as many were in critical need of a nutrition intervention at baseline. No group differences were observed regarding frailty status (P = 0.775). Sixty-one percent of the <400 m 6MWD group experienced at least one complication within 30 days of surgery compared to 21% in the ≥400 m group (P = 0.009).
CONCLUSION


Several preoperative characteristics were identified in the <400 m 6MWD group that could be useful in screening and targeting future prehabilitative treatments. Future trials should investigate use of a 400 m standard for the 6MWD as a minimal treatment target for prehabilitation.",2020,"Sixty-one percent of the <400 m 6MWD group experienced at least one complication within 30 days of surgery compared to 21% in the ≥400 m group (P = 0.009).
","['Patients participated in multimodal prehabilitation at home and in-hospital for approximately four weeks before colorectal surgery', 'Older frail prehabilitated patients who cannot attain a 400\xa0m 6-min walking distance before colorectal surgery suffer more postoperative complications', 'prehabilitate intermediately frail and frail (Fried frailty criteria ≥2) elective colorectal cancer patients', 'intermediately frail and frail prehabilitated patients who could not attain a minimum 400\xa0m (a prognostic cut-point used in other patient populations']",['6MWD'],"['6-min walking distance (6MWD', 'frailty status', 'minimum walking distance', 'incidence of postoperative complications within 30 days of hospital discharge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",28.0,0.181178,"Sixty-one percent of the <400 m 6MWD group experienced at least one complication within 30 days of surgery compared to 21% in the ≥400 m group (P = 0.009).
","[{'ForeName': 'Chelsia', 'Initials': 'C', 'LastName': 'Gillis', 'Affiliation': 'Cumming School of Medicine, Department of Community Health Sciences, University of Calgary, Canada; Nutrition Lead, Peri Operative Program, McGill University, Montreal, Calgary, Alberta, Canada.'}, {'ForeName': 'Tanis R', 'Initials': 'TR', 'LastName': 'Fenton', 'Affiliation': ""Department of Community Health Sciences, Institute of Public Health, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Canada; Nutrition Services, Alberta Health Services, Calgary, Canada.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Gramlich', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Tolulope T', 'Initials': 'TT', 'LastName': 'Sajobi', 'Affiliation': ""Cumming School of Medicine, Department of Community Health Sciences & O'Brien Institute for Public Health, University of Calgary, Calgary, Canada.""}, {'ForeName': 'S Nicole', 'Initials': 'SN', 'LastName': 'Culos-Reed', 'Affiliation': 'Faculty of Kinesiology and Department of Oncology, Cumming School of Medicine, University of Calgary. Psychosocial Resources, Tom Baker Cancer Centre, Cancer Care, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bousquet-Dion', 'Affiliation': 'Department of Surgery, McGill University Health Center, Montreal, QC, Canada.'}, {'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Elsherbini', 'Affiliation': 'Faculty of Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Julio F', 'Initials': 'JF', 'LastName': 'Fiore', 'Affiliation': 'Department of Surgery, McGill University Health Center, Montreal, QC, Canada.'}, {'ForeName': 'Enrico M', 'Initials': 'EM', 'LastName': 'Minnella', 'Affiliation': 'Department of Anesthesia, McGill University Health Center, Montreal, QC, Canada.'}, {'ForeName': 'Rashami', 'Initials': 'R', 'LastName': 'Awasthi', 'Affiliation': 'Department of Anesthesia, McGill University Health Center, Montreal, QC, Canada.'}, {'ForeName': 'A Sender', 'Initials': 'AS', 'LastName': 'Liberman', 'Affiliation': 'Department of Surgery, McGill University Health Center, Montreal, QC, Canada.'}, {'ForeName': 'Marylise', 'Initials': 'M', 'LastName': 'Boutros', 'Affiliation': 'Department of Surgery, McGill University Health Center, Montreal, QC, Canada.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': 'Department of Anesthesia, McGill University Health Center, Montreal, QC, Canada. Electronic address: franco.carli@mcgill.ca.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2020.09.041']
2066,33041107,Patterns of Physical Activity Progression in Patients With COPD.,"INTRODUCTION


Although mean physical activity in COPD patients declines by 400-500steps/day annually, it is unknown whether the natural progression is the same for all patients. We aimed to identify distinct physical activity progression patterns using a hypothesis-free approach and to assess their determinants.
METHODS


We pooled data from two cohorts (usual care arm of Urban Training [NCT01897298] and PROactive initial validation [NCT01388218] studies) measuring physical activity at baseline and 12 months (Dynaport MoveMonitor). We identified clusters (patterns) of physical activity progression (based on levels and changes of steps/day) using k-means, and compared baseline sociodemographic, interpersonal, environmental, clinical and psychological characteristics across patterns.
RESULTS


In 291 COPD patients (mean±SD 68±8 years, 81% male, FEV 1  59±19% pred ) we identified three distinct physical activity progression patterns: Inactive (n=173 [59%], baseline: 4621±1757 steps/day, 12-month change (Δ): -487±1201 steps/day), ActiveImprovers (n=49 [17%], baseline: 7727±3275 steps/day, Δ:+3378±2203 steps/day) and ActiveDecliners (n=69 [24%], baseline: 11 267±3009 steps/day, Δ: -2217±2085 steps/day). After adjustment in a mixed multinomial logistic regression model using Active Decliners as reference pattern, a lower 6-min walking distance (RRR [95% CI] 0.94 [0.90-0.98] per 10m, P=.001) and a higher mMRC dyspnea score (1.71 [1.12-2.60] per 1 point, P=.012) were independently related with being Inactive. No baseline variable was independently associated with being an Active Improver.
CONCLUSIONS


The natural progression in physical activity over time in COPD patients is heterogeneous. While Inactive patients relate to worse scores for clinical COPD characteristics, Active Improvers and Decliners cannot be predicted at baseline.",2020,"No baseline variable was independently associated with being an Active Improver.
","['COPD patients', '291 COPD patients (mean±SD 68±8 years, 81% male, FEV 1  59±19% pred ) we identified three distinct physical activity progression patterns: Inactive (n=173 [59%], baseline: 4621±1757 steps/day, 12-month change (Δ): -487±1201 steps/day), ActiveImprovers (n=49 [17%], baseline: 7727±3275 steps/day, Δ:+3378±2203 steps/day) and ActiveDecliners (n=69 [24%], baseline: 11 267±3009 steps/day, Δ', 'Patients With COPD']",[],"['mMRC dyspnea score', 'mean physical activity', 'physical activity']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0205449', 'cui_str': '3'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",[],"[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",291.0,0.101945,"No baseline variable was independently associated with being an Active Improver.
","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Koreny', 'Affiliation': 'ISGlobal, Barcelona, Spain; Pompeu Fabra University (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Demeyer', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven - University of Leuven, Leuven, Belgium; Department of Respiratory Diseases, University Hospitals KU Leuven, Leuven, Belgium; Department of Rehabilitation Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Benet', 'Affiliation': 'ISGlobal, Barcelona, Spain; Pompeu Fabra University (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Ane', 'Initials': 'A', 'LastName': 'Arbillaga-Etxarri', 'Affiliation': 'Physical Activity and Sports Sciences, Faculty of Psychology and Education, University of Deusto, Donostia-San Sebastián, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Balcells', 'Affiliation': ""Pompeu Fabra University (UPF), Barcelona, Spain; CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain; Pneumology Department, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Hospital del Mar, Barcelona, Spain.""}, {'ForeName': 'Anael', 'Initials': 'A', 'LastName': 'Barberan-Garcia', 'Affiliation': ""University of Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), CIBER Enfermedades Respiratorias (CIBERES), Hospital Clínic, Barcelona, Spain.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gimeno-Santos', 'Affiliation': ""University of Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), CIBER Enfermedades Respiratorias (CIBERES), Hospital Clínic, Barcelona, Spain.""}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Hopkinson', 'Affiliation': 'National Heart and Lung Institute, Imperial College, Royal Brompton Hospital Campus, London UK.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'De Jong', 'Affiliation': 'Department of General Practice, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands; Groningen Research Institute for Asthma and COPD (GRIAC), University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Karlsson', 'Affiliation': 'Patient Centered Science, BioPharmaceuticals, AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Zafeiris', 'Initials': 'Z', 'LastName': 'Louvaris', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven - University of Leuven, Leuven, Belgium; First Department of Respiratory Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Polkey', 'Affiliation': 'National Heart and Lung Institute, Imperial College, Royal Brompton Hospital Campus, London UK.'}, {'ForeName': 'Milo A', 'Initials': 'MA', 'LastName': 'Puhan', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Roberto A', 'Initials': 'RA', 'LastName': 'Rabinovich', 'Affiliation': ""ELEGI Colt Laboratory, Centre for Inflammation Research, The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rodríguez-Roisin', 'Affiliation': ""University of Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), CIBER Enfermedades Respiratorias (CIBERES), Hospital Clínic, Barcelona, Spain.""}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Vall-Casas', 'Affiliation': 'Universitat Internacional de Catalunya (UIC), Barcelona, Spain.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Vogiatzis', 'Affiliation': 'First Department of Respiratory Medicine, National and Kapodistrian University of Athens, Athens, Greece; Department of Sport, Exercise and Rehabilitation, Northumbria University Newcastle, Newcastle UK.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Troosters', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven - University of Leuven, Leuven, Belgium; Department of Respiratory Diseases, University Hospitals KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Garcia-Aymerich', 'Affiliation': 'ISGlobal, Barcelona, Spain; Pompeu Fabra University (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain. Electronic address: judith.garcia@isglobal.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Ane', 'Initials': 'A', 'LastName': 'Arbillaga-Etxarri', 'Affiliation': 'ISGlobal, Barcelona.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Benet', 'Affiliation': 'ISGlobal, Barcelona.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Delgado', 'Affiliation': 'ISGlobal, Barcelona.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Garcia-Aymerich', 'Affiliation': 'ISGlobal, Barcelona.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gimeno-Santos', 'Affiliation': 'ISGlobal, Barcelona.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Torrent-Pallicer', 'Affiliation': 'ISGlobal, Barcelona.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Vilaró', 'Affiliation': 'FCS Blanquerna, Universitat Ramon Llull, Barcelona.'}, {'ForeName': 'Anael', 'Initials': 'A', 'LastName': 'Barberan-Garcia', 'Affiliation': 'Servei de Pneumologia, Hospital Clínic de Barcelona, Barcelona.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Balcells', 'Affiliation': ""Hospital del Mar, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Barcelona.""}, {'ForeName': 'Diego A Rodríguez', 'Initials': 'DAR', 'LastName': 'Chiaradía', 'Affiliation': ""Hospital del Mar, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Barcelona.""}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Marín', 'Affiliation': 'Hospital Universitari Germans Trias i Pujol, Badalona.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Ortega', 'Affiliation': 'Hospital de Mataró, Consorci Sanitari del Maresme, Mataró.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Celorrio', 'Affiliation': 'Hospital de Viladecans, Viladecans.'}, {'ForeName': 'Mónica Mon', 'Initials': 'MM', 'LastName': 'Teagudo', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol).""}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Montellà', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol).""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Muñoz', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol).""}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Toran', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol).""}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Simonet', 'Affiliation': ""Centre d'Atenció Primària Viladecans 2, Institut Català de la Salut, Viladecans.""}, {'ForeName': 'Carme', 'Initials': 'C', 'LastName': 'Jané', 'Affiliation': ""Centre d'Atenció Primària Passeig de Sant Joan, Institut Català de la Salut, Barcelona.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Martín-Cantera', 'Affiliation': ""Centre d'Atenció Primària Passeig de Sant Joan, Institut Català de la Salut, Barcelona.""}, {'ForeName': 'Eulàlia', 'Initials': 'E', 'LastName': 'Borrell', 'Affiliation': ""Centre d'Atenció Primària Sant Roc, Institut Català de la Salut, Badalona.""}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Vall-Casas', 'Affiliation': 'Universitat Internacional de Catalunya (UIC), Barcelona.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Ivanoff', 'Affiliation': 'Almirall, Barcelona, Spain.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Karlsson', 'Affiliation': 'AstraZeneca AB, Mölndal, Sweden.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Corriol-Rohou', 'Affiliation': 'AstraZeneca AB, Mölndal, Sweden.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Jarrod', 'Affiliation': 'British Lung Foundation, London, UK.'}, {'ForeName': 'Damijen', 'Initials': 'D', 'LastName': 'Erzen', 'Affiliation': 'Boehringer Ingelheim, Nieder-Ingelheim, Germany.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Brindicci', 'Affiliation': 'Chiesi Farmaceutici S.A. Parma, Italy.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Higenbottam', 'Affiliation': 'Chiesi Farmaceutici S.A. Parma, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Scuri', 'Affiliation': 'Chiesi Farmaceutici S.A. Parma, Italy.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McBride', 'Affiliation': 'Choice Healthcare Solutions, Hitchin, UK.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Kamel', 'Affiliation': 'European Respiratory Society, Lausanne, Switzerland.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Tabberer', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Troosters', 'Affiliation': 'Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Dobbels', 'Affiliation': 'Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Garcia-Aymerich', 'Affiliation': 'Municipal Institute of Medical Research, Barcelona, Spain.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'de Boer', 'Affiliation': 'Netherlands Asthma Foundation, Amersfoort, The Netherlands.'}, {'ForeName': 'Karoly', 'Initials': 'K', 'LastName': 'Kulich', 'Affiliation': 'Novartis, Basel, Switzerland.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Glendenning', 'Affiliation': 'Novartis, Basel, Switzerland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Rudell', 'Affiliation': 'Pfizer Walton Oaks, UK.'}, {'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Wilson', 'Affiliation': 'Pfizer Walton Oaks, UK.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Polkey', 'Affiliation': 'Royal Brompton and Harefield NHS Foundation Trust, London, UK.'}, {'ForeName': 'Nick S', 'Initials': 'NS', 'LastName': 'Hopkinson', 'Affiliation': 'Royal Brompton and Harefield NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Vogiatzis', 'Affiliation': 'Thorax Research Foundation, Athens, Greece.'}, {'ForeName': 'Enkeleida', 'Initials': 'E', 'LastName': 'Nikai', 'Affiliation': 'UCB, Brussels, Belgium.'}, {'ForeName': 'Thys', 'Initials': 'T', 'LastName': 'van der Molen', 'Affiliation': 'University Medical Center, Groningen, The Netherlands.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'De Jong', 'Affiliation': 'University Medical Center, Groningen, The Netherlands.'}, {'ForeName': 'Roberto A', 'Initials': 'RA', 'LastName': 'Rabinovich', 'Affiliation': 'University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'MacNee', 'Affiliation': 'University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Milo A', 'Initials': 'MA', 'LastName': 'Puhan', 'Affiliation': 'University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Frei', 'Affiliation': 'University of Zurich, Zurich, Switzerland.'}]",Archivos de bronconeumologia,['10.1016/j.arbres.2020.08.001']
2067,33041226,Association of Consensus Molecular Subtypes and Molecular Markers With Clinical Outcomes in Patients With Metastatic Colorectal Cancer: Biomarker Analyses From LUME-Colon 1.,"INTRODUCTION


LUME-Colon 1 (NCT02149108) was a global, placebo-controlled phase III study of nintedanib in advanced colorectal cancer (CRC). Pre-specified biomarker analyses investigated the association of CRC consensus molecular subtypes (CMS) and tumor genomic and circulating biomarkers with clinical outcomes.
MATERIALS AND METHODS


Archival tumor tissue, cell-free DNA (cfDNA), and plasma samples were collected for genomic, transcriptomic, and proteomic analyses to investigate potential associations between CRC CMS and other biomarkers with nintedanib response and clinical outcomes.
RESULTS


Of the 765 treated patients, 735, 245, and 192 patient samples were analyzed in the circulating protein, tumor tissue, and cfDNA datasets, respectively. Patients were classified as CMS1 (1.7%), CMS2 (27.7%), CMS3 (0.9%), CMS4 (51.5%), or unclassified (18.2%). Unclassified/mixed CMS was associated with longer overall survival (OS) with nintedanib vs. CMS2 or CMS4 (interaction P-value = .0086); no association was observed for CMS4. Gene expression-based pathway analysis revealed an association between vascular endothelial growth factor-related signaling and OS for nintedanib (P = .0498). The most frequently detected somatic mutations were APC (72.0% [tumor tissue] vs. 56.8% [cfDNA]), TP53 (47.1% vs. 34.9%), KRAS (40.8% vs. 28.6%), and PIK3CA (16.6% vs. 11.5%); concordance rates were > 80%. Median OS differences were observed for APC and TP53 mutations vs. wild-type in cfDNA, indicating a potential prognostic value. Circulating ANG-2, CA-9, CEACAM1, collagen-IV, IGFBP-1, ICAM-1, IL-8, and uPAR were potentially prognostic for both OS and progression-free survival.
CONCLUSION


We demonstrated the feasibility of large-scale biomarker analyses and CMS classification within a global clinical trial, and identified signals suggesting a potential for greater nintedanib treatment response in the unclassified/mixed CMS subgroup, despite these tumors showing heterogeneous patterns of CMS mixtures. Our results revealed a high degree of concordance in somatic mutations between tumor tissue and cfDNA. Associations with prognosis for cfDNA somatic mutations, as well as several protein-based biomarkers, may warrant further investigation in future trials.",2020,Gene expression-based pathway analysis revealed an association between vascular endothelial growth factor-related signaling and OS for nintedanib (P = .0498).,"['Of the 765 treated patients, 735, 245, and 192 patient samples', 'Patients With Metastatic Colorectal Cancer', 'advanced colorectal cancer (CRC']",[],"['overall survival (OS', 'CMS2', 'concordance rates', 'TP53', 'CMS3', 'Median OS differences', 'KRAS', 'Circulating ANG-2, CA-9, CEACAM1, collagen-IV, IGFBP-1, ICAM-1, IL-8, and uPAR']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C3849511', 'cui_str': 'ANGPT2 protein, human'}, {'cui': 'C0378910', 'cui_str': 'Lymphocyte antigen CD66A'}, {'cui': 'C0009333', 'cui_str': 'Collagen type IV'}, {'cui': 'C0071189', 'cui_str': 'IGFBP1 protein, human'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0071216', 'cui_str': 'Lymphocyte antigen CD87'}]",765.0,0.0326245,Gene expression-based pathway analysis revealed an association between vascular endothelial growth factor-related signaling and OS for nintedanib (P = .0498).,"[{'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA. Electronic address: lenz@med.usc.edu.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Argiles', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Tejpar', 'Affiliation': 'Digestive Oncology Unit and Centre for Human Genetics, UZ Leuven, Belgium; University Hospitals Leuven and KULeuven, Leuven, Belgium.'}, {'ForeName': 'Fortunato', 'Initials': 'F', 'LastName': 'Ciardiello', 'Affiliation': 'Dipartimento di Internistica Clinica e Sperimentale, Università degli Studi della Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Braunger', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Alexey V', 'Initials': 'AV', 'LastName': 'Salnikov', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Ogsen', 'Initials': 'O', 'LastName': 'Gabrielyan', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Schmid', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Höfler', 'Affiliation': 'Staburo GmbH, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kitzing', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'University Hospitals Leuven and KULeuven, Leuven, Belgium.'}]",Clinical colorectal cancer,['10.1016/j.clcc.2020.09.003']
2068,33041263,Evaluation of beneficial effect of a dual-task exercise based on Japanese transitional games in older adults: a pilot study.,"Not only does Japan has the world's longest healthy life expectancy, but also the world's longest average life span. This study investigated the effect of a novel dual-task (DT) exercise called ""Synapsology"" (SYNAP), developed as a game-like activity to improve older adults' physical and cognitive functions. Participants (n=24) with a mean age of 70.6 years (65-77 years) were randomly assigned to the SYNAP exercise group (SG, n=15) and the control group (CG, n=9). The SG participated in the DT intervention consisting of 60-minute sessions, twice a week, for 8 weeks. Physical function in timed-up-and-go had significant pre- and post- trial differences (P=0.017) in SG. In addition, cognitive function results in the a 25-hole trail-making peg test (P=0.004) and an oxidative stress marker (P=0.039) had a statistically significant difference within the SG. However, there were no significant differences in the physical and cognitive functions between SG and CG. In the study, older adults who participated in cognitive-motor DT intervention improved significantly with regard to motor ability and cognitive function results. Thus, a game-like DT exercise may help maintain the healthy life of older adults compared to no intervention.",2020,Physical function in timed-up-and-go had significant pre- and post- trial differences (P=0.017) in SG.,"['older adults who participated in', 'Participants (n=24) with a mean age of 70.6 years (65-77 years', 'Japanese transitional games in older adults', 'older adults']","['dual-task exercise', 'SYNAP exercise', 'cognitive-motor DT intervention', 'novel dual-task (DT) exercise called ""Synapsology"" (SYNAP', 'game-like DT exercise']","['Physical function', 'oxidative stress marker', 'physical and cognitive functions', 'motor ability and cognitive function results']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",,0.0163609,Physical function in timed-up-and-go had significant pre- and post- trial differences (P=0.017) in SG.,"[{'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Yoon', 'Affiliation': 'R&D Center for Tailor-Made QOL, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Isoda', 'Affiliation': 'R&D Center for Tailor-Made QOL, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Okura', 'Affiliation': 'R&D Center for Tailor-Made QOL, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}]",Aging,['10.18632/aging.103908']
2069,33041277,Evaluation of the marginal fit of monolithic crowns fabricated by direct and indirect digitization.,"PURPOSE


To evaluate the influence of intraoral and extraoral digitization systems on marginal discrepancy of monolithic lithium disilicate and monolithic zirconia computer-aided design-computer-aided manufacturing (CAD-CAM) crowns.
METHODS


Forty standardized machined stainless steel specimens with the characteristics of a first molar were manufactured and randomly assigned to two groups (n=20 each), depending on their material: monolithic lithium disilicate ceramic (LM), and monolithic zirconia (ZM). Then, each group was subdivided into two depending on the scanning system used: intraoral scanner (IOS), and extraoral scanner (EOS). The digitization process was standardized with two methacrylate devices, one for each scanner. After scanning and manufacturing of the crowns, the marginal discrepancy was measured under a scanning electron microscope (SEM). Data analysis was made using two-way analysis of variance (ANOVA) and the effect size with Cohen's d.
RESULTS


All the measurements were within the limits considered acceptable. Regardless the restorative material significant differences between scanners were observed, being the effect from low to moderate. However, no differences were observed between the scanners in either the lithium disilicate or zirconia group.
CONCLUSIONS


The intraoral scan showed lower marginal discrepancy than the extraoral scan in CAD-CAM monolithic crowns, but these differences were not observed in each of the ceramic systems.",2020,"The intraoral scan showed lower marginal discrepancy than the extraoral scan in CAD-CAM monolithic crowns, but these differences were not observed in each of the ceramic systems.","['Forty standardized machined stainless steel specimens with the characteristics of a first molar were manufactured and randomly assigned to two groups (n=20 each), depending on their material']","['intraoral scanner (IOS), and extraoral scanner (EOS', 'monolithic lithium disilicate ceramic (LM), and monolithic zirconia (ZM']",[],"[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0442089', 'cui_str': 'Extraoral approach'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}]",[],40.0,0.0412191,"The intraoral scan showed lower marginal discrepancy than the extraoral scan in CAD-CAM monolithic crowns, but these differences were not observed in each of the ceramic systems.","[{'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Freire', 'Affiliation': 'Department of Conservative Dentistry and Buccofacial Prostheses, University Complutense of Madrid, Madrid.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Gonzalo', 'Affiliation': 'Department of Conservative Dentistry and Buccofacial Prostheses, University Complutense of Madrid, Madrid.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Lopez-Suarez', 'Affiliation': 'Department of Conservative Dentistry and Buccofacial Prostheses, University Complutense of Madrid, Madrid.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Pelaez', 'Affiliation': 'Department of Conservative Dentistry and Buccofacial Prostheses, University Complutense of Madrid, Madrid.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Suarez', 'Affiliation': 'Department of Conservative Dentistry and Buccofacial Prostheses, University Complutense of Madrid, Madrid.'}]",Journal of prosthodontic research,['10.2186/jpr.JPR_D_20_00003']
2070,33041412,Evaluating the  My Life  self-determination model for older youth in foster care: Establishing efficacy and exploring moderation of response to intervention.,"Limited rigorous research has been conducted to evaluate the impact of interventions designed to promote the successful transitions of young people exiting foster care. The current study builds on previous experimental evaluations of the  My Life  Model (MLM) for self-determination enhancement, which demonstrated effectiveness in improving educational and transition-to-adulthood outcomes for youth in foster care with disabilities, including those with mental health challenges. The model features one-on-one youth-directed coaching and near-peer mentoring to increase self-determination and goal achievement. The current study was the first to test the impact of the model with a diverse population-based cohort of youth aged 16.5-18.5 in foster care (N=293), including those with and without disabilities, on key model outcome indicators of self-determination and self-efficacy. This study also explored potential moderation by disability status, trauma symptoms, placement stability, and placement restrictiveness. Findings show that, compared to the randomized control group, the treatment group had greater post-intervention and one-year follow-up gains on several indicators of self-determination. Moderation analysis demonstrated no difference in intervention effectiveness for youth with or without disabilities, suggesting the universality of this approach. Findings also suggest that foster youth participants with low-to-average risks in terms of placement stability, placement restrictiveness, and traumatic stress levels seem to benefit most from the intervention, although youth who are at higher risk due to low placement stability, high placement restriction, and high traumatic stress still showed some benefit of participating in the intervention on some measures.  My Life  is one of only a few intervention models with experimental evidence of effectiveness with older youth in foster care. This validation study establishes that the approach has benefits for both youth with and without disabilities, as well as providing the first information available on the influence of critical barriers facing many youth in care.",2020,"Moderation analysis demonstrated no difference in intervention effectiveness for youth with or without disabilities, suggesting the universality of this approach.","['diverse population-based cohort of youth aged 16.5-18.5 in foster care (N=293), including those with and without disabilities, on key model outcome indicators of self-determination and self-efficacy', 'youth in foster care with disabilities, including those with mental health challenges', 'older youth in foster care']",['My Life  Model (MLM'],"['intervention effectiveness', 'disability status, trauma symptoms, placement stability, and placement restrictiveness']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C2314896', 'cui_str': 'FAMMM'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",,0.0278476,"Moderation analysis demonstrated no difference in intervention effectiveness for youth with or without disabilities, suggesting the universality of this approach.","[{'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Blakeslee', 'Affiliation': 'Portland State University.'}, {'ForeName': 'Laurie E', 'Initials': 'LE', 'LastName': 'Powers', 'Affiliation': 'Portland State University.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Geenen', 'Affiliation': 'Portland State University.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'Portland State University.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Nelson', 'Affiliation': 'Oregon Department of Human Services Child Welfare.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Fullerton', 'Affiliation': 'Portland State University.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'George', 'Affiliation': 'Oregon Department of Human Services Child Welfare.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McHugh', 'Affiliation': 'Multnomah County Department of County Human Services.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Bryant', 'Affiliation': 'Portland State University.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Children and youth services review,['10.1016/j.childyouth.2020.105419']
2071,33041578,Comparative evaluation of buccal pad of fat with and without bovine collagen membrane in the management of oral submucous fibrosis: A prospective clinical study.,"Background


Oral submucous fibrosis (OSMF) is a chronic, debilitating disease characterized by juxtaepithelial fibrosis. The present study evaluates the efficacy of buccal fat pad (BFP) and bovine collagen membrane as reconstruction options.
Materials and Methods


The sample size includes 22 patients between 20 and 60 years, randomly distributed in two groups: Group I in which BFP was used and Group II where BFP with bovine collagen membrane was used after surgical resection of fibrotic bands. The clinical evaluation on postoperative 1 st , 3 rd , and 5 th  days and 1 st , 2 nd , 3 rd , 4 th , 12 th , and 24 th  weeks subsequently.
Results


The mean age in Group I was 27.17 ± 3.157 years and Group II was 37.90 ± 6.657 years. The mean preoperative mouth opening was 9.75 ± 6.717 and 8.90 ± 3.784 mm in Groups I and II, respectively. The mean duration of presenting illness in Group I was 9.75 ± 2.598 years and in Group II was 8.80 ± 1.989 years. There was no significant difference observed between Groups I and II in relation to reduced mouth opening and duration of symptoms ( P  > 0.05) except for age. No significant difference was observed between both the groups in relation to preoperative pain, burning sensation, cheek stiffness, mucosal suppleness, postoperative infection, and postoperative pain at days 1 and 5 and 1 st  week. There was a significant difference observed in postoperative pain among both the groups on the 3 rd  day and 2 nd  week.
Conclusion


In the present study, both the groups have proved to give better results, as BFP in the form of interposition material showed rapid epithelization and minimum wound contracture.",2020,"No significant difference was observed between both the groups in relation to preoperative pain, burning sensation, cheek stiffness, mucosal suppleness, postoperative infection, and postoperative pain at days 1 and 5 and 1 st  week.","['oral submucous fibrosis', '22 patients between 20 and 60 years']","['buccal fat pad (BFP) and bovine collagen membrane', 'BFP with bovine collagen membrane', 'buccal pad of fat with and without bovine collagen membrane', 'BFP']","['mean preoperative mouth opening', 'mouth opening and duration of symptoms', 'mean duration of presenting illness', 'preoperative pain, burning sensation, cheek stiffness, mucosal suppleness, postoperative infection, and postoperative pain', 'postoperative pain']","[{'cui': 'C0029172', 'cui_str': 'Oral submucosal fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226900', 'cui_str': 'Buccal fat pad'}, {'cui': 'C0772448', 'cui_str': 'Bovine collagen'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0007966', 'cui_str': 'Cheek structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",22.0,0.0182857,"No significant difference was observed between both the groups in relation to preoperative pain, burning sensation, cheek stiffness, mucosal suppleness, postoperative infection, and postoperative pain at days 1 and 5 and 1 st  week.","[{'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Naresh Kumar', 'Initials': 'NK', 'LastName': 'Sharma', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Neeraj Kumar', 'Initials': 'NK', 'LastName': 'Dhiman', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Chandresh', 'Initials': 'C', 'LastName': 'Jaiswara', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Tiwari', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Akhilesh Kumar', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Verma', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Shankar', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}]",National journal of maxillofacial surgery,['10.4103/njms.NJMS_70_19']
2072,33041579,Effect of antiplatelet therapy on minor dental procedures.,"Introduction


Minor oral surgical procedures are very common. Acetylsalicylic acid generically known as aspirin is used clinically as an analgesic, antipyretic, anti-inflammatory, and as a medication to prevent platelet aggregation.
Objective


The aim of this study was to determine if aspirin or clopidogrel was associated with bleeding after minor oral surgical procedures.
Materials and Methods


One hundred patients who were planned for extraction of the third molar were divided into two groups. In Group A, patients on antiplatelets were included and in Group B, patients who discontinued the drug before 5 days of procedure were included. The bleeding time of all patients was checked before extraction. The surgical procedure involved simple extraction of a single third molar tooth under local anesthesia. The extraction socket was sutured with 3-0 silk. A pressure pack of gauze was given for 1 h. Bleeding after 1 h and 24 h was compared between two groups. A Chi-square test was used to compare the variables.
Results


None of the patients showed active bleeding in the postoperative period. The results for postsurgical bleeding were statistically insignificant with  P  = 0.05.
Conclusion


Minor surgical procedures such as single-tooth extraction can be carried out without discontinuation of the antiplatelet therapy.",2020,"The results for postsurgical bleeding were statistically insignificant with  P  = 0.05.
","['minor dental procedures', 'One hundred patients who were planned for extraction of the third molar']","['aspirin or clopidogrel', 'Acetylsalicylic acid', 'antiplatelet therapy']","['postsurgical bleeding', 'bleeding time', 'active bleeding']","[{'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0005729', 'cui_str': 'Bleeding time'}, {'cui': 'C0205177', 'cui_str': 'Active'}]",100.0,0.0244383,"The results for postsurgical bleeding were statistically insignificant with  P  = 0.05.
","[{'ForeName': 'Altaf Hussain', 'Initials': 'AH', 'LastName': 'Malik', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Govt. Dental College, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Shabnum', 'Initials': 'S', 'LastName': 'Majeed', 'Affiliation': 'Department of Health and Medical Education, Srinagar, Jammu and Kashmir, India.'}]",National journal of maxillofacial surgery,['10.4103/njms.NJMS_30_19']
2073,33041580,Evaluation of efficacy of platelet-rich fibrin membrane and bone graft in coverage of immediate dental implant in esthetic zone: An  in vivo  study.,"Objective


This study compared and evaluated the clinical and radiographic results of guided bone regeneration using platelet-rich fibrin (PRF) and collagen membrane as barrier membrane in immediately placed implants with severe buccal bone defect (with respect to marginal bone level, implant stability quotient [ISQ]), and histological analysis of new bone formation.
Materials and Methods


Sixteen implants were placed in patients requiring immediate implant placement and having a buccal wall defect and randomly divided into two groups one receiving PRF membranes and other collagen membrane. The sites were grafted with bone-substitute material in both the groups. After 4 months, at the time of second-stage surgery, implant stability is measured by Osstell Mentor, crestal bone level on mesial and distal sides of implant by digital intraoral periapical, buccal defect clinically by probe and histological analysis of biopsied bone.
Results


The results were insignificant and comparable in both the groups when comparison was made between the groups. The mean buccal defect, mean values of average ISQ, crestal bone level in both the groups at baseline and after 4 months were compared. No significant difference between both the groups was found after 4 months. Bone quality seemed to be equal in both groups after histological analysis. Within the limits of the study, both the groups had shown similar results in all criteria.
Conclusion


Within the limitation of the study, it can be concluded that both the treatment modalities are successful in terms of buccal defect reduction, stability, and increase in crestal bone level.",2020,Bone quality seemed to be equal in both groups after histological analysis.,"['patients requiring immediate implant placement and having a buccal wall defect', 'esthetic zone', 'immediately placed implants with severe buccal bone defect']","['PRF membranes and other collagen membrane', 'platelet-rich fibrin membrane and bone graft', 'guided bone regeneration using platelet-rich fibrin (PRF) and collagen membrane']","['Bone quality', 'crestal bone level', 'mean buccal defect, mean values of average ISQ, crestal bone level', 'implant stability is measured by Osstell Mentor, crestal bone level on mesial and distal sides of implant by digital intraoral periapical, buccal defect clinically by probe and histological analysis of biopsied bone']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]","[{'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",16.0,0.0284652,Bone quality seemed to be equal in both groups after histological analysis.,"[{'ForeName': 'Romesh', 'Initials': 'R', 'LastName': 'Soni', 'Affiliation': 'Department of Prosthodontics, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Priya', 'Affiliation': 'Department of Prosthodontics, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Agrawal', 'Affiliation': 'Department of Oral Pathology, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Prosthodontics, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Lakshya', 'Initials': 'L', 'LastName': 'Kumar', 'Affiliation': ""Department of Prosthodontics, Crown and Bridges, Faculty of Dental Sciences, King George's Medical University, Lucknow, Uttar Pradesh, India.""}]",National journal of maxillofacial surgery,['10.4103/njms.NJMS_26_19']
2074,33041582,Periosteum eversion technique versus subpedicle connective tissue graft technique for root coverage of gingival recessions: A randomized split-mouth study.,"Introduction


The connective tissue graft (CTG) with pedicle flap as subpedicle CTG technique (SPCTGT) is considered the gold standard technique in the treatment of gingival recessions. The aim of this study was to compare periosteum eversion technique (PET) with SPCTGT for root coverage of gingival recessions.
Materials and Methods


Ten patients having bilateral gingival recessions of Miller class I and II were selected. The left or right side was randomly assigned into PET group and SPCTGT group. Before and after 1 year of surgery, depth of gingival recession (DGR), width of keratinized gingiva (WKG), width of attached gingiva (WAG), and probing depth (PD) were measured and compared. Pre- and post-groups were compared by paired  t -test. Two independent groups were compared by independent Student's  t -test. A two-tailed (α =2)  P  < 0.05 was considered statistically significant.
Results


Comparing the pre to post mean of PET and SPCTGT showed decrease (net improvement) in DGR (-5.80 ± 0.42 vs. -4.65 ± 0.39, mean difference = -1.15 ± 0.57, t = 2.02,  P  = 0.058) and in PD (-1.05 ± 0.12 vs. -0.60 ± 0.12, mean difference = -0.45 ± 0.17, t = 2.64,  P  = 0.017); and increase (net improvement) in WKG (5.80 ± 0.42 vs. 4.80 ± 0.41, mean difference = 1.00 ± 0.58, t = 1.71,  P  = 0.104) and in WAG (5.60 ± 0.32 vs. 4.90 ± 0.24, mean difference = 0.70 ± 0.41, t = 1.73,  P  = 0.101). PET showed 19.8% and 42.9% higher decrease in DGR and PD; and 17.2% and 12.5% higher increase in WKG and WAG, respectively, than SPCTGT.
Conclusions


The study found that both the modalities were effective in the management of root coverage of gingival recessions. However, PET was found more effective than SPCTGT.",2020,"PET showed 19.8% and 42.9% higher decrease in DGR and PD; and 17.2% and 12.5% higher increase in WKG and WAG, respectively, than SPCTGT.
",['patients having bilateral gingival recessions of Miller class'],"['connective tissue graft (CTG) with pedicle flap as subpedicle CTG technique (SPCTGT', 'PET', 'periosteum eversion technique (PET) with SPCTGT', 'Periosteum eversion technique versus subpedicle connective tissue graft technique']","['root coverage of gingival recessions', 'depth of gingival recession (DGR), width of keratinized gingiva (WKG), width of attached gingiva (WAG), and probing depth (PD', 'WKG and WAG', 'DGR and PD']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0450136', 'cui_str': 'Pedicle flap'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0031110', 'cui_str': 'Periosteum'}, {'cui': 'C0015211', 'cui_str': 'Eversion'}]","[{'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0182400', 'cui_str': 'Probe'}]",,0.0878102,"PET showed 19.8% and 42.9% higher decrease in DGR and PD; and 17.2% and 12.5% higher increase in WKG and WAG, respectively, than SPCTGT.
","[{'ForeName': 'Awadhesh Kumar', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'Department of Periodontology, Chandra Dental College and Hospital, Barabanki, Uttar Pradesh, India.'}, {'ForeName': 'Dhananjay Kumar', 'Initials': 'DK', 'LastName': 'Mali', 'Affiliation': 'Department of Periodontology, Chandra Dental College and Hospital, Barabanki, Uttar Pradesh, India.'}]",National journal of maxillofacial surgery,['10.4103/njms.NJMS_32_19']
2075,33041584,The efficacy of intralesional dexamethasone versus intravenous dexamethasone in surgery for impacted third molars: A randomized controlled trial.,"Objectives


A randomized prospective double-blind study was conducted to determine the efficacy of sub-mucosal local infiltration vs. intravenous dexamethasone in reducing postoperative pain, swelling and trismus after surgical removal of impacted mandibular third molars.
Materials and Methods


Forty five patients were included in the study and were randomly divided into three groups. Each group consisted of 15 patients for which the first and second groups were given 8 mg of dexamethasone intrlesionally & intravenously respectively, at 30 minutes prior to surgery; the third group served as control. Duration of facial swelling was evaluated subjectively by the patients themselves. Severity of postoperative pain was quantified by counting the number of analgesics taken by the patients during and after surgery (six subsequent days). Postoperative trismus was determined by measuring the maximum incisal opening before surgery and on the seventh day.
Results


Results showed that duration of postoperative edema was almost the same in the three test groups. During surgery, the intravenous dexamethasone group showed a significantly lesser pain than the other two groups; the intralesional dexamethasone group showed less marked pain than the control group. Additionally, patients who had taken steroids had a marked increase in the incisal opening postoperatively over the control group. Trismus was significantly reduced in the methylprednisolone group as compared to the dexamethasone group.
Conclusion


It is concluded that both preoperative local infiltration and intravenous administration of dexamethasone significantly reduced postoperative pain and trismus after surgical removal of mandibular third molars. An intravenous dexamethasone is more effective in reducing postoperative inflammatory sequelae than its intralesional route.",2020,"During surgery, the intravenous dexamethasone group showed a significantly lesser pain than the other two groups; the intralesional dexamethasone group showed less marked pain than the control group.","['Materials and Methods\n\n\nForty five patients were included in the study', 'after surgical removal of impacted mandibular third molars', 'surgery for impacted third molars']","['dexamethasone', 'sub-mucosal local infiltration vs. intravenous dexamethasone', 'methylprednisolone', 'intralesional dexamethasone']","['Duration of facial swelling', 'postoperative pain and trismus', 'Postoperative trismus', 'Severity of postoperative pain', 'Trismus', 'duration of postoperative edema', 'marked pain', 'postoperative pain, swelling and trismus', 'incisal opening postoperatively', 'postoperative inflammatory sequelae', 'pain']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C4040028', 'cui_str': 'Incisal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0243088', 'cui_str': 'sequels'}]",45.0,0.0581226,"During surgery, the intravenous dexamethasone group showed a significantly lesser pain than the other two groups; the intralesional dexamethasone group showed less marked pain than the control group.","[{'ForeName': 'Amiya', 'Initials': 'A', 'LastName': 'Agrawal', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Chandel', 'Affiliation': ""Department of Dentistry, Era's Lucknow Medical College, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Nishi', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Department of Periodontology, Career Post Graduate Institute of Dental Sciences and Hospital, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Arunesh Kumar', 'Initials': 'AK', 'LastName': 'Tiwari', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Akhilesh Kumar', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Singh', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Super Speciality Cancer Institute, Lucknow, Uttar Pradesh, India.'}]",National journal of maxillofacial surgery,['10.4103/njms.NJMS_46_17']
2076,33041619,The Effects of a Paraphrasing and Text Structure Intervention on the Main Idea Generation and Reading Comprehension of Students with Reading Disabilities in Grades 4 and 5.,"This study examined the effects of a small group intervention targeting paraphrasing and text structure instruction on the main idea generation and reading comprehension of students with reading disabilities in Grades 4 and 5. Students ( N  = 62) were randomly assigned to receive the Tier 2-type intervention or business-as-usual instruction. Students in the intervention received 25, 40-minute lessons focused on paraphrasing sections of text by identifying the main topic and the most important idea about that topic. Students utilized the text structure organization to inform their main idea generation. Results yielded statistically significant, positive effects in favor of the intervention group on near-transfer and mid-transfer measures of text structure identification ( g  = 0.75) and main idea generation ( g  = 0.70), but no statistically significant effect on a far-transfer measure of reading comprehension. These findings provide initial support for utilizing this instruction to improve students' main idea generation on taught and untaught structures.",2020,"Results yielded statistically significant, positive effects in favor of the intervention group on near-transfer and mid-transfer measures of text structure identification ( g  = 0.75) and main idea generation ( g  = 0.70), but no statistically significant effect on a far-transfer measure of reading comprehension.","['Students with Reading Disabilities in Grades 4 and 5', 'students with reading disabilities in Grades 4 and 5', 'Students ( N  = 62']","['Tier 2-type intervention or business-as-usual instruction', 'small group intervention targeting paraphrasing and text structure instruction', 'Paraphrasing and Text Structure Intervention']","['transfer measure of reading comprehension', 'near-transfer and mid-transfer measures of text structure identification']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0476254', 'cui_str': 'Dyslexia'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}]",62.0,0.029522,"Results yielded statistically significant, positive effects in favor of the intervention group on near-transfer and mid-transfer measures of text structure identification ( g  = 0.75) and main idea generation ( g  = 0.70), but no statistically significant effect on a far-transfer measure of reading comprehension.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Stevens', 'Affiliation': 'Georgia State University.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Vaughn', 'Affiliation': 'The University of Texas at Austin.'}, {'ForeName': 'Lexy', 'Initials': 'L', 'LastName': 'House', 'Affiliation': 'The University of Texas at Austin.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Stillman-Spisak', 'Affiliation': 'The University of Texas at Austin.'}]",Scientific studies of reading : the official journal of the Society for the Scientific Study of Reading,['10.1080/10888438.2019.1684925']
2077,33041659,Impact of social problem-solving training on critical thinking and decision making of nursing students.,"Background


The complex health system and challenging patient care environment require experienced nurses, especially those with high cognitive skills such as problem-solving, decision- making and critical thinking. Therefore, this study investigated the impact of social problem-solving training on nursing students' critical thinking and decision-making.
Methods


This study was quasi-experimental research and pre-test and post-test design and performed on 40 undergraduate/four-year students of nursing in Borujen Nursing School/Iran that was randomly divided into 2 groups; experimental ( n  = 20) and control (n = 20). Then, a social problem-solving course was held for the experimental group. A demographic questionnaire, social problem-solving inventory-revised, California critical thinking test, and decision-making questionnaire was used to collect the information. The reliability and validity of all of them were confirmed. Data analysis was performed using SPSS software and independent sampled T-test, paired T-test, square chi, and Pearson correlation coefficient.
Results


The finding indicated that the social problem-solving course positively affected the student' social problem-solving and decision-making and critical thinking skills after the instructional course in the experimental group ( P  < 0.05), but this result was not observed in the control group ( P  > 0.05).
Conclusions


The results showed that structured social problem-solving training could improve cognitive problem-solving, critical thinking, and decision-making skills. Considering this result, nursing education should be presented using new strategies and creative and different ways from traditional education methods. Cognitive skills training should be integrated in the nursing curriculum. Therefore, training cognitive skills such as problem- solving to nursing students is recommended.",2020,"The finding indicated that the social problem-solving course positively affected the student' social problem-solving and decision-making and critical thinking skills after the instructional course in the experimental group ( P  < 0.05), but this result was not observed in the control group ( P  > 0.05).
","['40 undergraduate/four-year students of nursing in Borujen Nursing School/Iran', 'nursing students']","['Cognitive skills training', 'social problem-solving training', 'structured social problem-solving training']","['cognitive problem-solving, critical thinking, and decision-making skills', ""student' social problem-solving and decision-making and critical thinking skills""]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0036380', 'cui_str': 'Nursing Schools'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0579088', 'cui_str': 'Cognitive skills training'}, {'cui': 'C0037431', 'cui_str': 'Social problem'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C4279941', 'cui_str': 'Critical Thinking'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0037431', 'cui_str': 'Social problem'}]",40.0,0.0139952,"The finding indicated that the social problem-solving course positively affected the student' social problem-solving and decision-making and critical thinking skills after the instructional course in the experimental group ( P  < 0.05), but this result was not observed in the control group ( P  > 0.05).
","[{'ForeName': 'Soleiman', 'Initials': 'S', 'LastName': 'Ahmady', 'Affiliation': 'Department of Medical Education, Virtual School of Medical Education and Management, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Shahbazi', 'Affiliation': 'Virtual School of Medical Education and management, Shahid Beheshty University of Medical Sciences, Tehran, Iran.'}]",BMC nursing,['10.1186/s12912-020-00487-x']
2078,33041703,"Efficacy of Spore Forming Bacilli Supplementation in Patients with Mild to Moderate Elevation of Triglycerides: A 12 week, Randomized, Double-Blind, Placebo Controlled Trial.","Objective


The purpose of this randomized double-blind placebo controlled clinical trial was to evaluate the effects of a commercial spore-based probiotic supplement consisting of 5 different spore forming bacilli ( Bacillus indicus  HU36,  Bacillus subtilis  HU58,  Bacillus coagulans  SC-208,  Bacillus licheniformis , and  Bacillus clausii  SC-109) on reducing the triglyceride levels (TG) in patients with mild to moderate hypertriglyceridemia (HT).
Study design


A randomized, double-blind, placebo-controlled study with eighty participants with non-fasting triglyceride levels greater than 150 mg/dL.
Methods


Eighty participants with non-fasting triglyceride levels greater than 150 mg/dL were randomized to receive oral probiotic supplement consisting of two capsules containing 5 different spore forming bacilli once daily in the morning or a placebo (rice flour). Their non-fasting triglyceride levels were measured again at six weeks and at twelve weeks.
Results


Compared to the placebo group, participants in the probiotic supplement group had significant lowering of their triglyceride levels after 90 days.
Conclusion


Mild to moderately elevated triglyceride levels can be lowered in patients with mild to moderate HT by a probiotic supplement consisting of five different spore forming bacilli.",2020,"Compared to the placebo group, participants in the probiotic supplement group had significant lowering of their triglyceride levels after 90 days.
","['patients with mild to moderate hypertriglyceridemia (HT', 'eighty participants with non-fasting triglyceride levels', 'Patients with Mild to Moderate Elevation of Triglycerides', 'Eighty participants with non-fasting triglyceride levels greater than 150 mg/dL']","['commercial spore-based probiotic supplement', 'Spore Forming Bacilli Supplementation', 'placebo', 'placebo (rice flour', 'Placebo']","['triglyceride levels', 'triglyceride levels (TG', 'non-fasting triglyceride levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0038027', 'cui_str': 'Spores'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0016260', 'cui_str': 'Flour'}]","[{'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",80.0,0.624982,"Compared to the placebo group, participants in the probiotic supplement group had significant lowering of their triglyceride levels after 90 days.
","[{'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Campbell', 'Affiliation': 'Medical Director of Mymycolab in Land O Lakes, Florida.'}, {'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Sinatra', 'Affiliation': 'naturopathic doctor of integrative medicine at the CLEAR Center for Health in Mill Valley, California.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Statistics-University of California Riverside, in Riverside California.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Sinatra', 'Affiliation': 'assistant clinical professor of medicine at the School of Medicine, University of Connecticut in Farmington, Connecticut.'}]","Integrative medicine (Encinitas, Calif.)",[]
2079,33042004,Efficacy of a 2-Month Very Low-Calorie Ketogenic Diet (VLCKD) Compared to a Standard Low-Calorie Diet in Reducing Visceral and Liver Fat Accumulation in Patients With Obesity.,"Background:  Currently the treatment of non-alcoholic fatty liver disease (NAFLD) is based on weight loss through lifestyle changes, such as exercise combined with calorie-restricted dieting.  Objectives:  To assess the effects of a commercially available weight loss program based on a very low-calorie ketogenic diet (VLCKD) on visceral adipose tissue (VAT) and liver fat content compared to a standard low-calorie (LC) diet. As a secondary aim, we evaluated the effect on liver stiffness measurements.  Methods:  Open, randomized controlled, prospective pilot study. Patients were randomized and treated either with an LC or a VLCKD and received orientation and encouragement to physical activity equally for both groups. VAT, liver fat fraction, and liver stiffness were measured at baseline and after 2 months of treatment using magnetic resonance imaging. Paired  t -tests were used for comparison of continuous variables between visits and unpaired test between groups. Categorical variables were compared using the χ 2 -test. Pearson correlation was used to assess the association between VAT, anthropometric measures, and hepatic fat fraction. A significance level of the results was established at  p  < 0.05.  Results:  Thirty-nine patients (20 with VLCKD and 19 with LC) were evaluated at baseline and 2 months of intervention. Relative weight loss at 2 months was -9.59 ± 2.87% in the VLCKD group and -1.87 ± 2.4% in the LC group ( p  < 0.001). Mean reductions in VAT were -32.0 cm 2  for VLCKD group and -12.58 cm 2  for LC group ( p  < 0.05). Reductions in liver fat fraction were significantly more pronounced in the VLCKD group than in the LC group (4.77 vs. 0.79%;  p  < 0.005).  Conclusion:  Patients undergoing a VLCKD achieved superior weight loss, with significant VAT and liver fat fraction reductions when compared to the standard LC diet. The weight loss and rapid mobilization of liver fat demonstrated with VLCKD could serve as an effective alternative for the treatment of NAFLD.  Clinical Trial Registration:  ClinicalTrials.gov, identifier: NCT04322110.",2020,Reductions in liver fat fraction were significantly more pronounced in the VLCKD group than in the LC group (4.77 vs. 0.79%;  p  < 0.005).  ,"['non-alcoholic fatty liver disease (NAFLD', 'Patients With Obesity', 'Results:  Thirty-nine patients (20 with VLCKD and 19 with LC']","['2-Month Very Low-Calorie Ketogenic Diet (VLCKD', 'calorie ketogenic diet (VLCKD', 'VLCKD', 'LC or a VLCKD and received orientation and encouragement to physical activity', 'standard low-calorie (LC) diet', 'Standard Low-Calorie Diet']","['Reductions in liver fat fraction', 'weight loss', 'VAT, liver fat fraction, and liver stiffness', 'VAT and liver fat fraction reductions', 'Mean reductions in VAT', 'Relative weight loss', 'visceral adipose tissue (VAT) and liver fat content', 'Visceral and Liver Fat Accumulation', 'superior weight loss', 'VAT, anthropometric measures, and hepatic fat fraction']","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3816447', 'cui_str': '39'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0042427', 'cui_str': 'Vatican City'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205054', 'cui_str': 'Portal'}]",39.0,0.0371284,Reductions in liver fat fraction were significantly more pronounced in the VLCKD group than in the LC group (4.77 vs. 0.79%;  p  < 0.005).  ,"[{'ForeName': 'Guilherme Moura', 'Initials': 'GM', 'LastName': 'Cunha', 'Affiliation': 'Department of Radiology, University of California, San Diego, La Jolla, CA, United States.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Guzman', 'Affiliation': 'Pronokal Group, Barcelona, Spain.'}, {'ForeName': 'Livia Lugarinho', 'Initials': 'LL', 'LastName': 'Correa De Mello', 'Affiliation': 'Instituto Estadual de Diabetes e Endocrinologia Luiz Capriglione, Rio de Janeiro, Brazil.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Trein', 'Affiliation': 'Instituto Estadual de Diabetes e Endocrinologia Luiz Capriglione, Rio de Janeiro, Brazil.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Spina', 'Affiliation': 'Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Isabela', 'Initials': 'I', 'LastName': 'Bussade', 'Affiliation': 'Clínica Isabela Bussade, Rio de Janeiro, Brazil.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Marques Prata', 'Affiliation': 'Clinical Diagnostic Imaging (CDPI), Rio de Janeiro, Brazil.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Sajoux', 'Affiliation': 'Pronokal Group, Barcelona, Spain.'}, {'ForeName': 'Walmir', 'Initials': 'W', 'LastName': 'Countinho', 'Affiliation': 'Instituto Estadual de Diabetes e Endocrinologia Luiz Capriglione, Rio de Janeiro, Brazil.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.00607']
2080,33042013,Development and Interpretation of Multiple Machine Learning Models for Predicting Postoperative Delayed Remission of Acromegaly Patients During Long-Term Follow-Up.,"Background:  Some patients with acromegaly do not reach the remission standard in the short term after surgery but achieve remission without additional postoperative treatment during long-term follow-up; this phenomenon is defined as postoperative delayed remission (DR). DR may complicate the interpretation of surgical outcomes in patients with acromegaly and interfere with decision-making regarding postoperative adjuvant therapy.  Objective:  We aimed to develop and validate machine learning (ML) models for predicting DR in acromegaly patients who have not achieved remission within 6 months of surgery.  Methods:  We enrolled 306 acromegaly patients and randomly divided them into training and test datasets. We used the recursive feature elimination (RFE) algorithm to select features and applied six ML algorithms to construct DR prediction models. The performance of these ML models was validated using receiver operating characteristics analysis. We used permutation importance, SHapley Additive exPlanations (SHAP), and local interpretable model-agnostic explanation (LIME) algorithms to determine the importance of the selected features and interpret the ML models.  Results:  Fifty-five (17.97%) acromegaly patients met the criteria for DR, and five features (post-1w rGH, post-1w nGH, post-6m rGH, post-6m IGF-1, and post-6m nGH) were significantly associated with DR in both the training and the test datasets. After the RFE feature selection, the XGboost model, which comprised the 15 important features, had the greatest discriminatory ability (area under the curve = 0.8349, sensitivity = 0.8889, Youden's index = 0.6842). The XGboost model showed good discrimination ability and provided significantly better estimates of DR of patients with acromegaly compared with using only the Knosp grade. The results obtained from permutation importance, SHAP, and LIME algorithms showed that post-6m IGF-1 is the most important feature in XGboost algorithm prediction and showed the reliability and the clinical practicability of the XGboost model in DR prediction.  Conclusions:  ML-based models can serve as an effective non-invasive approach to predicting DR and could aid in determining individual treatment and follow-up strategies for acromegaly patients who have not achieved remission within 6 months of surgery.",2020,The XGboost model showed good discrimination ability and provided significantly better estimates of DR of patients with acromegaly compared with using only the Knosp grade.,"['patients with acromegaly and interfere with decision-making regarding postoperative adjuvant therapy', 'Acromegaly Patients', 'acromegaly patients who have not achieved remission within 6 months of surgery']","['SHapley Additive exPlanations (SHAP), and local interpretable model-agnostic explanation (LIME']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001206', 'cui_str': 'Acromegaly'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0442796', 'cui_str': 'Additive'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0337688', 'cui_str': 'Agnostic movement'}, {'cui': 'C0064990', 'cui_str': 'Calcium oxide'}]",[],306.0,0.0247683,The XGboost model showed good discrimination ability and provided significantly better estimates of DR of patients with acromegaly compared with using only the Knosp grade.,"[{'ForeName': 'Congxin', 'Initials': 'C', 'LastName': 'Dai', 'Affiliation': 'Department of Neurosurgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanghua', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Neurosurgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yichao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'DHC Mediway Technology Co., Ltd., Beijing, China.'}, {'ForeName': 'Xinjie', 'Initials': 'X', 'LastName': 'Bao', 'Affiliation': 'Department of Neurosurgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yansheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'DHC Mediway Technology Co., Ltd., Beijing, China.'}, {'ForeName': 'Mingliang', 'Initials': 'M', 'LastName': 'Su', 'Affiliation': 'DHC Mediway Technology Co., Ltd., Beijing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Neurosurgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Deng', 'Affiliation': 'Department of Neurosurgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Xing', 'Affiliation': 'Department of Neurosurgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Feng', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Feng', 'Affiliation': 'Department of Neurosurgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Renzhi', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.00643']
2081,33042205,Oatmeal induced gut microbiota alteration and its relationship with improved lipid profiles: a secondary analysis of a randomized clinical trial.,"Background


In vitro and animal experiments reported a microbiota-regulating ability of oatmeal, however, related in vivo evidences remained limited. Thus, we conducted this study aiming to investigate the oatmeal-induced alteration of gut microbiota and its potential relationship with the improvements of lipid profiles.
Methods and study design


Data of anthropometric measurements and biochemical parameters were extracted from a randomized, controlled clinical trial, in which 62 hypercholesterolemic men and women (18-65 years old) were provided with either treatment of 80 g/day oatmeal or 80 g/day refined white rice for 45 days. Fasting blood samples and fecal samples were collected both at baseline and endpoint of the study for lipid profiling and microbiota 16S rRNA amplicon sequencing, respectively.
Results


Totally 28 participants (56 fecal samples) qualified with the new criteria and were thus included in this secondary analysis. The results of microbiota analysis showed that no significant difference was observed in the alteration of its overall α or β diversity between two groups throughout the study. Nor did any notable between-group difference was found in the relative abundance changes of microorganism at different taxonomies. However, results from linear discriminant analysis effect size in the oatmeal group indicated a significant positive response of Firmicutes phylum following oatmeal consumption. Further Procrustes analysis suggested a concordance trend between microorganism alteration and alleviation of hypercholesterolemia phenotypes throughout the study ( P  = 0.05). The results of within-group comparison from Spearman's correlation in the oatmeal group demonstrated a significant association between the enrichment of Blautia genus and the reduction of serum total cholesterol ( P  < 0.05), low-density lipoprotein cholesterol ( P  < 0.01), and apolipoprotein B ( P  < 0.05).
Conclusions


Positive response of Firmicutes phylum might be a critical characteristic of oatmeal-induced alteration of microbiota, whereas, one of the underlying cholesterol-lowering mechanism of oatmeal consumption might be its microbiota-manipulating ability, in which the enrichment of Blautia genus played a potentially significant role. Current results should be taken cautiously and more studies were needed for further verification. Trial registration : ChiCTR, ChiCTR180001864. Registered 30 September 2018, http://www.chictr.org.cn/showproj.aspx?proj=31469.",2020,Nor did any notable between-group difference was found in the relative abundance changes of microorganism at different taxonomies.,"['62 hypercholesterolemic men and women (18-65\xa0years old', 'Totally 28 participants (56 fecal samples) qualified with the new criteria and were thus included in this secondary analysis']",[],"['lipid profiles', 'Fasting blood samples and fecal samples', 'hypercholesterolemia phenotypes', 'alteration of its overall α or β diversity', 'apolipoprotein B', 'serum total cholesterol', 'low-density lipoprotein cholesterol']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",28.0,0.0552185,Nor did any notable between-group difference was found in the relative abundance changes of microorganism at different taxonomies.,"[{'ForeName': 'Mengyao', 'Initials': 'M', 'LastName': 'Ye', 'Affiliation': ""Clinical Nutrition Center, Huadong Hospital Affiliated to Fudan University, 221 West Yan'an Road, Shanghai, 200040 People's Republic of China.""}, {'ForeName': 'Jianqin', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Clinical Nutrition Center, Huadong Hospital Affiliated to Fudan University, 221 West Yan'an Road, Shanghai, 200040 People's Republic of China.""}, {'ForeName': 'Yanqiu', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Clinical Nutrition Center, Huadong Hospital Affiliated to Fudan University, 221 West Yan'an Road, Shanghai, 200040 People's Republic of China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Ren', 'Affiliation': ""Clinical Nutrition Center, Huadong Hospital Affiliated to Fudan University, 221 West Yan'an Road, Shanghai, 200040 People's Republic of China.""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Clinical Nutrition Center, Huadong Hospital Affiliated to Fudan University, 221 West Yan'an Road, Shanghai, 200040 People's Republic of China.""}, {'ForeName': 'Yanfang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Clinical Nutrition Center, Huadong Hospital Affiliated to Fudan University, 221 West Yan'an Road, Shanghai, 200040 People's Republic of China.""}, {'ForeName': 'Yiru', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ""Huadong Hospital Affiliated to Fudan University, 221 West Yan'an Road, Shanghai, 200040 People's Republic of China.""}, {'ForeName': 'Huijun', 'Initials': 'H', 'LastName': 'Xue', 'Affiliation': ""Huadong Hospital Affiliated to Fudan University, 221 West Yan'an Road, Shanghai, 200040 People's Republic of China.""}]",Nutrition & metabolism,['10.1186/s12986-020-00505-4']
2082,33042339,Comparison of application value between conventional air insufflation and water infusion in colonoscopy.,"OBJECTIVE


To discuss the feasibility of water infusion colonoscopy and its difference with traditional air insufflation colonoscopy in application value.
METHODS


A prospective randomized controlled clinical study was designed to include 200 patients who underwent sedation-free diagnostic colonoscopy. Among them, 100 patients were treated with water infusion colonoscopy (observation group) and 100 patients were treated with air insufflation colonoscopy (control group). All operations were performed independently by the same experienced physician. The differences in colonoscopy related values, colon adenoma detection rate, and follow-up findings between the patients of two groups were compared.
RESULTS


There was no significant difference in the Boston bowel preparation scale (BBPS) score of the left hemicolon, transverse colon, right hemicolon, total BBPS scores, and bubble amount between the two groups (P>0.05). In the observation group, the scope-forward time, the time to reach the ileocecal junction, and the total operation time were significantly longer than that of the control group (P<0.01). The proportion of patients in whom the ileocecal junction was successfully reached was significantly higher in the observation group. The intraoperative abdominal pain visual analog scale (VAS) score, abdominal distension VAS score, the proportion of postural change, and the proportion of abdominal compression were all significantly lower in the observation group (P<0.05). There were no significant differences in the endoscope hardness adjustment rate, the scope withdrawal time, total detection rate of adenomas, and the size or location of colon adenomatous lesions between the two groups (P>0.05). Compared with control group, the incidence of abdominal pain and VAS scores were significantly lower in the observation group (P<0.05), and the willingness of patients to perform colonoscopy again was significantly higher (P<0.01).
CONCLUSION


Patients' tolerance and examination satisfaction are significantly better when using water infusion colonoscopy compared with traditional air insufflation colonoscopy, but the operation times are longer.",2020,"There were no significant differences in the endoscope hardness adjustment rate, the scope withdrawal time, total detection rate of adenomas, and the size or location of colon adenomatous lesions between the two groups (P>0.05).","['100 patients were treated with water infusion colonoscopy (observation group) and 100 patients were treated with', '200 patients who underwent sedation-free diagnostic colonoscopy']","['traditional air insufflation colonoscopy', 'conventional air insufflation and water infusion', 'water infusion colonoscopy', 'air insufflation colonoscopy (control group']","['Boston bowel preparation scale (BBPS) score of the left hemicolon, transverse colon, right hemicolon, total BBPS scores, and bubble amount', 'tolerance and examination satisfaction', 'endoscope hardness adjustment rate, the scope withdrawal time, total detection rate of adenomas, and the size or location of colon adenomatous lesions', 'intraoperative abdominal pain visual analog scale (VAS) score, abdominal distension VAS score, the proportion of postural change, and the proportion of abdominal compression', 'total operation time', 'colonoscopy related values, colon adenoma detection rate', 'incidence of abdominal pain and VAS scores']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0400018', 'cui_str': 'Diagnostic endoscopic examination on colon'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0227386', 'cui_str': 'Transverse colon structure'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4551463', 'cui_str': 'Colon adenoma'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",200.0,0.0157544,"There were no significant differences in the endoscope hardness adjustment rate, the scope withdrawal time, total detection rate of adenomas, and the size or location of colon adenomatous lesions between the two groups (P>0.05).","[{'ForeName': ""Li'an"", 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': ""Department of Colorectal Surgery, Yuyao People's Hospital Yuyao, Zhejiang Province, China.""}, {'ForeName': 'Jifu', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': ""Department of Colorectal Surgery, Yuyao People's Hospital Yuyao, Zhejiang Province, China.""}, {'ForeName': 'Junquan', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': ""Department of Colorectal Surgery, Yuyao People's Hospital Yuyao, Zhejiang Province, China.""}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Sang', 'Affiliation': ""Department of Colorectal Surgery, Yuyao People's Hospital Yuyao, Zhejiang Province, China.""}, {'ForeName': 'Huanjun', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Department of Colorectal Surgery, Yuyao People's Hospital Yuyao, Zhejiang Province, China.""}]",International journal of clinical and experimental pathology,[]
2083,33042378,"Regulatory Fit: Impact on Anxiety, Arousal, and Performance in College-Level Soccer Players.","Sport performance may be facilitated using regulatory fit, which is a match between individuals' situational strategy and their chronic self-regulatory strategy. However, researchers have not examined the impact of regulatory fit on psychological and physiological components of sport performance, such as anxiety and arousal. Therefore, the purpose of this study was to evaluate the psychophysiological reactions to regulatory fit by examining anxiety, arousal, and sport performance. Female college-level soccer players (n = 25) were randomly assigned to the regulatory match or regulatory mismatch conditions and completed anxiety (Competitive Sport Anxiety Inventory-2R, CSAI-2R) and underwent arousal (heart rate variability, HRV; pre-ejection period, PEP) measures pre- and post-regulatory focus manipulation. Subsequently, participants completed a sport performance task (10 penalty kicks). The impact of regulatory fit on the dependent variables was explored through repeated measures ANOVAs. Results revealed a significant time effect for cognitive anxiety and self-confidence subscales of the CSAI-2R, suggesting the penalty kicking task increased cognitive anxiety and reduced self-confidence in all participants. In addition, there was a significant interaction effect of condition on pre-ejection period (PEP), with a greater increase in PEP for those experiencing regulatory fit compared to those who were not. There were non-significant interaction and main effects for all other variables. Since PEP is an inverse measure of sympathetic (SNS) modulation, experiencing regulatory fit may reduce SNS involvement in the heartbeat. Thus, the current results indicate experiencing regulatory fit may influence arousal prior to athletic competition.",2020,"Results revealed a significant time effect for cognitive anxiety and self-confidence subscales of the CSAI-2R, suggesting the penalty kicking task increased cognitive anxiety and reduced self-confidence in all participants.","['Female college-level soccer players (n = 25', 'College-Level Soccer Players']","['regulatory match or regulatory mismatch conditions and completed anxiety (Competitive Sport Anxiety Inventory-2R, CSAI-2R) and underwent arousal (heart rate variability, HRV; pre-ejection period, PEP) measures pre- and post-regulatory focus manipulation']","['cognitive anxiety and reduced self-confidence', 'PEP', 'cognitive anxiety and self-confidence subscales', 'Anxiety, Arousal, and Performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0336969', 'cui_str': 'Ejection'}, {'cui': 'C0031642', 'cui_str': 'Phosphoenolpyruvate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0031642', 'cui_str': 'Phosphoenolpyruvate'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]",25.0,0.0321772,"Results revealed a significant time effect for cognitive anxiety and self-confidence subscales of the CSAI-2R, suggesting the penalty kicking task increased cognitive anxiety and reduced self-confidence in all participants.","[{'ForeName': 'Brianna N', 'Initials': 'BN', 'LastName': 'Leitzelar', 'Affiliation': 'School of Kinesiology, Ball State University, Muncie, IN, USA.'}, {'ForeName': 'Lindsey C', 'Initials': 'LC', 'LastName': 'Blom', 'Affiliation': 'School of Kinesiology, Ball State University, Muncie, IN, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Guilkey', 'Affiliation': 'Department of Kinesiology, Coastal Carolina University, Conway, SC, USA.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Bolin', 'Affiliation': 'Department of Educational Psychology, Ball State University, Muncie, IN, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mahon', 'Affiliation': 'School of Kinesiology, Ball State University, Muncie, IN, USA.'}]",International journal of exercise science,[]
2084,33042381,Ischemic Preconditioning Does Not Improve Time Trial Performance in Recreational Runners.,"Some evidence indicates that ischemic preconditioning (IPC) may positively affect endurance exercise performance, but IPC's effect on running performance is unclear. This study's purpose was to examine the effect of IPC on running performance in recreational runners. Participants (n=12) completed IPC, a sham (SH) condition, and a leg elevation without blood restriction (LE) control condition on separate days (order randomized). For IPC, blood was restricted using blood pressure cuffs inflated to 220 mmHg at the thigh. For SH, the cuffs were inflated to only 20 mmHg. For LE, participants positioned their legs at 90 degrees against a wall while laying supine. The duration of each protocol was 30 minutes (three 5-minute bouts with 5-minute breaks). Following each protocol, participants ran 2.4 kilometers as fast as possible on a motorized treadmill. Run time, heart rate, and perceived exertion were measured and statistically compared, using repeated-measures ANOVA, each 0.8 kilometers. There were no differences in heart rate or time trial performance across protocols (p>0.05; IPC, 612.5±61.2 sec; SH, 608.1±57.9 sec; LE, 612.7±59.1 sec). Rating of perceived exertion at 0.8 kilometers was significantly lower for the IPC protocol than SH in females only (~5.7%, or ~0.8 points on a 6-20 scale; p<0.05). Our IPC protocol did not improve running performance or physiological parameters during a time trial run in recreational runners. The performance benefit seen in this study's most fit individuals suggests that fitness level may influence IPC's efficacy for improving endurance running performance.",2020,"There were no differences in heart rate or time trial performance across protocols (p>0.05; IPC, 612.5±61.2 sec; SH, 608.1±57.9 sec; LE, 612.7±59.1 sec).","['recreational runners', 'Participants (n=12) completed', 'Recreational Runners']","['Ischemic Preconditioning', 'IPC', 'IPC, a sham (SH) condition, and a leg elevation without blood restriction (LE) control condition', 'ischemic preconditioning (IPC']","['Run time, heart rate, and perceived exertion', 'Rating of perceived exertion', 'endurance exercise performance', 'heart rate or time trial performance', 'running performance or physiological parameters']","[{'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.24388,"There were no differences in heart rate or time trial performance across protocols (p>0.05; IPC, 612.5±61.2 sec; SH, 608.1±57.9 sec; LE, 612.7±59.1 sec).","[{'ForeName': 'Alexander H K', 'Initials': 'AHK', 'LastName': 'Montoye', 'Affiliation': 'Department of Integrative Physiology and Health Science, Alma College, Alma, MI, USA.'}, {'ForeName': 'Clara J', 'Initials': 'CJ', 'LastName': 'Mitchinson', 'Affiliation': 'Department of Kinesiology, Hope College, Holland, MI, USA.'}, {'ForeName': 'Olivia R', 'Initials': 'OR', 'LastName': 'Townsend', 'Affiliation': 'Department of Kinesiology, Hope College, Holland, MI, USA.'}, {'ForeName': 'Conner H', 'Initials': 'CH', 'LastName': 'Nemmers', 'Affiliation': 'Department of Kinesiology, Hope College, Holland, MI, USA.'}, {'ForeName': 'Caroline N', 'Initials': 'CN', 'LastName': 'Serkaian', 'Affiliation': 'Department of Kinesiology, Hope College, Holland, MI, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Rider', 'Affiliation': 'Department of Kinesiology, Hope College, Holland, MI, USA.'}]",International journal of exercise science,[]
2085,33042461,The use of virtual reality for Peri-procedural pain and anxiety at an outpatient spine clinic injection visit: an exploratory controlled randomized trial.,"Chronic pain is a major public health problem. There is a need to develop novel treatment strategies to address this growing issue. Virtual reality is emerging as an alternative approach to help people suffering from chronic pain. The purpose of this work was to explore the feasibility, acceptability, and impact of a brief virtual reality relaxation video on peri-procedural pain and anxiety in chronic low back pain patients receiving spinal injections. The intervention was delivered in the context of a busy fluoroscopy injection clinic. Upon arrival to the clinic, consented patients were randomized into one of three groups: (1) Audiovisual monitor-flat screen (AV) (2) Virtual Reality headset (VR) and (3) Control-no intervention. The main questions we set out to answer were: (1) Is it feasible to deliver the intervention in the context of clinical care? (2) Was the intervention acceptable to patients? and (3) Did the intervention impact pain and anxiety surrounding the injection procedure? Viewing a brief relaxation nature video in AV or VR format was not associated with statistically lower pain scores following an injection procedure compared to controls. However, the intervention was associated with lower anxiety scores recorded prior to the injection compared to controls. Importantly, the virtual reality intervention was acceptable and feasible to integrate into a clinic setting, however, to maximize effectiveness, the content delivered to this population should be targeted and delivered over a longer duration. In addition, alternative outcomes and settings beyond peri-procedural pain surrounding an injection should be explored.",2020,Viewing a brief relaxation nature video in AV or VR format was not associated with statistically lower pain scores following an injection procedure compared to controls.,"['chronic low back pain patients receiving spinal injections', 'people suffering from chronic pain']","['virtual reality intervention', 'Audiovisual monitor-flat screen (AV) (2) Virtual Reality headset (VR) and (3) Control-no intervention', 'virtual reality relaxation video']","['Chronic pain', 'pain scores', 'lower anxiety scores']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021498', 'cui_str': 'Spinal Injections'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0278513,Viewing a brief relaxation nature video in AV or VR format was not associated with statistically lower pain scores following an injection procedure compared to controls.,"[{'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Orthopedic Spine Center, Mass General Hospital Boston, MA, USA.'}, {'ForeName': 'Eric T', 'Initials': 'ET', 'LastName': 'Chen', 'Affiliation': 'Harvard Medical School Boston, MA, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Binder', 'Affiliation': 'Harvard Medical School Boston, MA, USA.'}]",American journal of translational research,[]
2086,33025926,Auto-controlled Syringe vs Insulin Syringe for Palatal Injections in Children: A Randomized Crossover Trial.,"AIM


This study aims to evaluate and compare the efficacy of auto-control syringe (ACS) and insulin syringe (IS) for palatal local anesthesia administration in children.
MATERIALS AND METHODS


The study was a double-blind, randomized, and crossover trial, comprising 80 children requiring palatal anesthesia bilaterally (total 160 injections). Palatal anesthesia on one side was delivered with ACS in one appointment and contralaterally with IS in the second appointment. One-week washout period was given between first and second appointments. Each child acted as his own control. Each injection technique subjective and objective pain scores were measured twice (during needle prick and during actual deposition of local anesthesia). Subjective and objective evaluation of pain was measured with Wong-Baker FACES pain rating scale (WB-FPS) and the face, leg, activity, cry, and consolability scale (FLACC), respectively. After concluding second appointment, child was asked about their preference between both ACS and IS. Statistical evaluation was performed using Chi-square test.
RESULTS


Child reported less pain score for needle prick with IS as opposed to ACS ( p  value = 0.000416). There was no significant difference between dentist-reported pain scores between any group for both needle prick and local anesthesia administration. There is no significant difference between child reported pain score during administration of local anesthesia between two groups. Irrespective of pain scores, most of the children (96.5%) preferred IS.
CONCLUSION


For palatal local anesthesia administration in children, both IS and auto-controlled syringe have similar efficacy.
CLINICAL SIGNIFICANCE


Insulin syringe can serve as an economical alternative to the expensive auto-controlled syringe for palatal injections in children.",2020,There was no significant difference between dentist-reported pain scores between any group for both needle prick and local anesthesia administration.,"['children', 'Children', '80 children requiring palatal anesthesia bilaterally (total 160 injections']","['Auto-controlled Syringe vs Insulin Syringe', 'auto-control syringe (ACS) and insulin syringe (IS']","['objective pain scores', 'pain score', 'Subjective and objective evaluation of pain', 'Baker FACES pain rating scale (WB-FPS) and the face, leg, activity, cry, and consolability scale (FLACC', 'pain scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4285979', 'cui_str': 'Palatal anaesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}]",80.0,0.0630243,There was no significant difference between dentist-reported pain scores between any group for both needle prick and local anesthesia administration.,"[{'ForeName': 'Sunny Priyatham', 'Initials': 'SP', 'LastName': 'Tirupathi', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Malla Reddy Institute of Dental Sciences, Hyderabad, Telangana, India, e-mail: dr.priyatham@gmail.com.'}, {'ForeName': 'Srinitya', 'Initials': 'S', 'LastName': 'Rajasekhar', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Malla Reddy Institute of Dental Sciences, Hyderabad, Telangana, India.'}, {'ForeName': 'Pushpalatha', 'Initials': 'P', 'LastName': 'Tummakomma', 'Affiliation': 'Department of Periodontics, Malla Reddy Institute of Dental Sciences, Hyderabad, Telangana, India.'}, {'ForeName': 'Aishwarya Arya', 'Initials': 'AA', 'LastName': 'Gangili', 'Affiliation': 'Department of Periodontics, Malla Reddy Institute of Dental Sciences, Hyderabad, Telangana, India.'}, {'ForeName': 'Abdul Rehman Ahmed', 'Initials': 'ARA', 'LastName': 'Khan', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Majmaah University, College of Dentistry, Al Zulfi, Kingdom of Saudi Arabia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Khurramuddin', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Malla Reddy Institute of Dental Sciences, Hyderabad, Telangana, India.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Purumandla', 'Affiliation': 'Department of Periodontics, Malla Reddy Institute of Dental Sciences, Hyderabad, Telangana, India.'}]",The journal of contemporary dental practice,[]
2087,33027156,Behavioral interventions can mitigate adverse pregnancy outcomes among women conceiving on antiretroviral therapy (ART) and those initiated on ART during pregnancy: Findings from the MOTIVATE trial in southwestern Kenya.,"BACKGROUND


Antiretroviral treatment (ART) is essential for the elimination of mother-to-child transmission and improved health outcomes for women living with HIV (WLWH). However, adverse pregnancy outcomes (APO) among pregnant women on ART are a growing concern.
METHODS


We investigated the associations between timing of ART initiation and APO among pregnant WLWH receiving behavioral interventions (community mentor mothers and text messaging) in the Mother-Infant Visit Adherence and Treatment Engagement (MOTIVATE) study in southwestern Kenya. Log binomial models were used for estimation of relative risks (RRs) (adjusted for the clustered nature of data) evaluating APO with three exposure comparisons 1) Preconception ART initiation vs. post-conception initiation, 2) among post-conception ART initiating women, comparisons across gestational ages at cART initiation (first versus second and third trimester exposure) and, 3) intervention allocation.
RESULTS


Of the 1275 women included in this analysis, 388 (30%) had an APO: 306 preterm births, 38 low birth weight infants, 33 stillbirths and 11 miscarriages. In multivariable analysis, viral load >1000 copies/ml, moderate and severe anemia at baseline increased risk of APO. Among women initiating ART before and after conception, no difference was observed in the composite APO. Women who received community mentor mother visits only (aRR 0.74: 95% CI 0.71-0.76), or text messages only (aRR 0.79: 95% CI 0.70-0.89) had lower risks of experiencing any APO.
CONCLUSIONS


Receiving supportive behavioral interventions may mitigate the risk of experiencing an APO among WLWH on ART. Further studies are needed to investigate the underlying mechanisms and optimize the benefits of these interventions.",2020,"Women who received community mentor mother visits only (aRR 0.74: 95% CI 0.71-0.76), or text messages only (aRR 0.79: 95% CI 0.70-0.89) had lower risks of experiencing any APO.
","['1275 women included in this analysis, 388 (30%) had an APO: 306 preterm births, 38 low birth weight infants, 33 stillbirths and 11 miscarriages', 'pregnant women', 'women living with HIV (WLWH', 'women conceiving on antiretroviral therapy (ART) and those initiated on ART during pregnancy: Findings from the MOTIVATE trial in southwestern Kenya', 'pregnant WLWH receiving behavioral interventions (community mentor mothers and text messaging) in the Mother-Infant Visit Adherence and Treatment Engagement (MOTIVATE) study in southwestern Kenya']",['Behavioral interventions'],"['adverse pregnancy outcomes (APO', 'risk of APO', 'composite APO', 'lower risks of experiencing any APO', 'moderate and severe anemia']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0021288', 'cui_str': 'Low birth weight infant'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",1275.0,0.257313,"Women who received community mentor mother visits only (aRR 0.74: 95% CI 0.71-0.76), or text messages only (aRR 0.79: 95% CI 0.70-0.89) had lower risks of experiencing any APO.
","[{'ForeName': 'Maricianah', 'Initials': 'M', 'LastName': 'Onono', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Odwar', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Wahome', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Helova', 'Affiliation': 'Department of Health Care Policy and Organization, School of Public Health, University of Alabama at Birmingham, Birmingham, United States.'}, {'ForeName': 'Elizabeth Anne', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hampanda', 'Affiliation': 'Department of Community and Behavioral Health, School of Public Health, University of Colorado Denver, Aurora, United States.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Turan', 'Affiliation': 'Department of Health Care Policy and Organization, School of Public Health, University of Alabama at Birmingham, Birmingham, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Abuogi', 'Affiliation': 'Department of Pediatrics, University of Colorado Denver, Aurora, United States.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002521']
2088,33028425,Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest: a statistical analysis plan.,"BACKGROUND


To date, targeted temperature management (TTM) is the only neuroprotective intervention after resuscitation from cardiac arrest that is recommended by guidelines. The evidence on the effects of TTM is unclear.
METHODS/DESIGN


The Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest (TTM2) trial is an international, multicentre, parallel group, investigator-initiated, randomised, superiority trial in which TTM with a target temperature of 33 °C after cardiac arrest will be compared with a strategy to maintain normothermia and active treatment of fever (≥ 37.8 °C). Prognosticators, outcome assessors, the steering group, the trial coordinating team, and trial statisticians will be blinded to treatment allocation. The primary outcome will be all-cause mortality at 180 days after randomisation. We estimate a 55% mortality in the targeted normothermia group. To detect an absolute risk reduction of 7.5% with an alpha of 0.05 and 90% power, 1900 participants will be enrolled. The secondary neurological outcome will be poor functional outcome (modified Rankin scale 4-6) at 180 days after cardiac arrest. In this paper, a detailed statistical analysis plan is presented, including a comprehensive description of the statistical analyses, handling of missing data, and assessments of underlying statistical assumptions. Final analyses will be conducted independently by two qualified statisticians following the present plan.
DISCUSSION


This SAP, which was prepared before completion of enrolment, should increase the validity of the TTM trial by mitigation of analysis-bias.",2020,The secondary neurological outcome will be poor functional outcome (modified Rankin scale 4-6) at 180 days after cardiac arrest.,['1900 participants will be enrolled'],"['Hypothermia Versus Targeted Normothermia', 'TTM']","['cause mortality', 'absolute risk reduction']",[],"[{'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",1900.0,0.144936,The secondary neurological outcome will be poor functional outcome (modified Rankin scale 4-6) at 180 days after cardiac arrest.,"[{'ForeName': 'Janus Christian', 'Initials': 'JC', 'LastName': 'Jakobsen', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Tagensvej 22, Copenhagen, Denmark. jcj@ctu.dk.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Dankiewicz', 'Affiliation': 'Department of Clinical Sciences, Cardiology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Section of Biostatistics, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Cronberg', 'Affiliation': 'Department of Clinical Sciences, Neurology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Lilja', 'Affiliation': 'Department of Clinical Sciences, Neurology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Levin', 'Affiliation': 'Department of Clinical Sciences, Research and Education, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bělohlávek', 'Affiliation': '2nd Department of Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Clifton', 'Initials': 'C', 'LastName': 'Callaway', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Cariou', 'Affiliation': 'Medical Intensive Care Unit, Cochin University Hospital (APHP) and Paris Descartes University, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Clinical Sciences, Cardiology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hovdenes', 'Affiliation': 'Department of Anesthesia and Intensive Care, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joannidis', 'Affiliation': 'Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nordberg', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Oddo', 'Affiliation': 'Department of Intensive Care Medicine, Faculty of Biology and Medicine, Centre Hospitalier Universitaire Vaudois (CHUV) - University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostics (DISC), University of Genoa, Genoa, Italy.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kirkegaard', 'Affiliation': 'Research Center for Emergency Medicine, Department of Clinical Medicine, Aarhus University Hospital and Aarhus University, Aarhus N, Denmark.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Eastwood', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Heidelberg, Australia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rylander', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Saxena', 'Affiliation': 'Bankstown Hospital Clinical School and The George Institute for Global Health, University of New South Wales, Kensington, Australia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Storm', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Fabio Silvio', 'Initials': 'FS', 'LastName': 'Taccone', 'Affiliation': 'Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgium.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Wise', 'Affiliation': 'Adult Critical Care, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Matt P G', 'Initials': 'MPG', 'LastName': 'Morgan', 'Affiliation': 'Adult Critical Care, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Nichol', 'Affiliation': ""University Collage Dublin-Clinical Research Centre, St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Friberg', 'Affiliation': 'Department of Clinical Sciences, Anesthesia & Intensive Care, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Ullén', 'Affiliation': 'Clinical Studies Sweden, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'Department of Clinical Sciences Lund, Anesthesia & Intensive Care, Lund University, Helsingborg Hospital, Lund, Sweden.'}]",Trials,['10.1186/s13063-020-04654-y']
2089,33032643,"Phase I/IIa trial of androgen deprivation therapy, external beam radiotherapy, and stereotactic body radiotherapy boost for high-risk prostate cancer (ADEBAR).","BACKGROUND


To evaluate the clinical outcomes of combination of androgen deprivation therapy (ADT), whole pelvic radiotherapy (WPRT), and stereotactic body radiotherapy (SBRT) boost in high-risk prostate cancer patients.
METHODS


This prospective phase I/IIa study was conducted between 2016 and 2017. Following WPRT of 44 Gy in 20 fractions, patients were randomized to two boost doses, 18 Gy and 21 Gy, in 3 fractions using the Cyberknife system. Primary endpoints were incidences of acute toxicities and short-term biochemical recurrence-free survival (BCRFS). Secondary endpoints included late toxicities and short-term clinical progression-free survival (CPFS).
RESULTS


A total of 26 patients were enrolled. Twelve patients received a boost dose of 18 Gy, and the rest received 21 Gy. The Median follow-up duration was 35 months. There were no grade ≥ 3 genitourinary (GU) or gastrointestinal (GI) toxicities. Sixty-one and 4% of patients experienced grade 1-2 acute GU and GI toxicities, respectively. There were 12% late grade 1-2 GU toxicities and 8% late grade 1-2 GI toxicities. Patient-reported outcomes of urinary symptoms were aggravated after WPRT and SBRT boost. However, they resolved at 1 month and returned to the baseline level at 4 months. Three-year BCRFS was 88.1%, and CPFS was 92.3%.
CONCLUSIONS


The present study protocol demonstrated that the combination of ADT, WPRT, and SBRT boosts for high-risk prostate cancer is safe and feasible, and may reduce total treatment time to 5 weeks. Boost dose of 21 Gy in 3 fractions seems appropriate.
TRIAL REGISTRATION


ClinicalTrials.gov, ID; NCT03322020 - Retrospectively registered on 26 October 2017.",2020,There were no grade ≥ 3 genitourinary (GU) or gastrointestinal (GI) toxicities.,"['high-risk prostate cancer patients', 'high-risk prostate cancer (ADEBAR', '26 patients were enrolled', 'IIa study was conducted between 2016 and 2017', 'NCT03322020 - Retrospectively registered on 26 October 2017']","['ADT, WPRT, and SBRT boosts', 'androgen deprivation therapy, external beam radiotherapy, and stereotactic body radiotherapy boost', 'androgen deprivation therapy (ADT), whole pelvic radiotherapy (WPRT), and stereotactic body radiotherapy (SBRT']","['late toxicities and short-term clinical progression-free survival (CPFS', 'grade 1-2 acute GU and GI toxicities', 'incidences of acute toxicities and short-term biochemical recurrence-free survival (BCRFS', 'grade\u2009≥\u20093 genitourinary (GU) or gastrointestinal (GI) toxicities', 'late grade 1-2 GU toxicities and 8% late grade 1-2 GI toxicities', 'urinary symptoms']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}]",26.0,0.162873,There were no grade ≥ 3 genitourinary (GU) or gastrointestinal (GI) toxicities.,"[{'ForeName': 'Yeon Joo', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Asan Medical Center, University of Ulsan, College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.'}, {'ForeName': 'Hanjong', 'Initials': 'H', 'LastName': 'Ahn', 'Affiliation': 'Department of Urology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Choung-Soo', 'Initials': 'CS', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young Seok', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Asan Medical Center, University of Ulsan, College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea. ysk@amc.seoul.kr.'}]","Radiation oncology (London, England)",['10.1186/s13014-020-01665-6']
2090,33032657,Quetiapine augmentation of prolonged exposure therapy in veterans with PTSD and a history of mild traumatic brain injury: design and methodology of a pilot study.,"BACKGROUND


Selective serotonergic reuptake inhibitors (SSRIs) are first-line pharmacologic treatments for patients with posttraumatic stress disorder (PTSD), but must be given over extended period of time before the onset of action. The use of SSRIs in PTSD patients with mild traumatic brain injury (mTBI) is problematic since SSRIs could exacerbate post-concussion syndrome (PCS) symptoms. VA/DOD guidelines identify trauma-focused psychotherapy as the best evidence-based treatment for PTSD, but overall effectiveness is limited by reduced levels of patient engagement and retention. A previous study from this research group suggested that quetiapine monotherapy, but not risperidone or valproate, could increase engagement in trauma-focused psychotherapy.
METHODS


We report the study protocol of a pilot study funded under the South-Central Mental Illness Research, Education, and Clinical Center pilot study program from the U.S. Department of Veterans Affairs. This randomized, open-label study was designed to evaluate the feasibility of completing a randomized trial of quetiapine vs. treatment as usual to promote patient engagement in PTSD patients with a history of mTBI.
DISCUSSION


We expect that the success of this ongoing study should provide us with the preliminary data necessary to design a full-scale randomized trial. Positive efficacy results in a full- scale trial should inform new VA guidelines for clinical practice by showing that quetiapine-related improvements in patient engagement and retention may be the most effective approach to assure that VA resources achieve the best possible outcome for veterans.
TRIAL REGISTRATION


NCT04280965 .",2020,"Positive efficacy results in a full- scale trial should inform new VA guidelines for clinical practice by showing that quetiapine-related improvements in patient engagement and retention may be the most effective approach to assure that VA resources achieve the best possible outcome for veterans.
","['PTSD patients with a history of mTBI', 'pilot study funded under the South-Central Mental Illness Research, Education, and Clinical Center pilot study program from the U.S. Department of Veterans Affairs', 'PTSD patients with mild traumatic brain injury (mTBI', 'patients with posttraumatic stress disorder (PTSD', 'veterans with PTSD and a history of mild traumatic brain injury']","['Quetiapine', 'serotonergic reuptake inhibitors (SSRIs', 'quetiapine monotherapy', 'quetiapine', 'SSRIs', 'risperidone or valproate']",[],"[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}]",[],,0.0674027,"Positive efficacy results in a full- scale trial should inform new VA guidelines for clinical practice by showing that quetiapine-related improvements in patient engagement and retention may be the most effective approach to assure that VA resources achieve the best possible outcome for veterans.
","[{'ForeName': 'Muhammad R', 'Initials': 'MR', 'LastName': 'Baig', 'Affiliation': 'Mental Health, South Texas Veterans Healthcare System, 116 A, 7400 Merton Minter Blvd, San Antonio, TX, 78229, USA. Muhammad.baig@va.gov.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Beck', 'Affiliation': 'Mental Health, South Texas Veterans Healthcare System, 116 A, 7400 Merton Minter Blvd, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Wilson', 'Affiliation': 'Mental Health, South Texas Veterans Healthcare System, 116 A, 7400 Merton Minter Blvd, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Lemmer', 'Affiliation': 'Mental Health, South Texas Veterans Healthcare System, 116 A, 7400 Merton Minter Blvd, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Adeel', 'Initials': 'A', 'LastName': 'Meraj', 'Affiliation': 'Mental Health, South Texas Veterans Healthcare System, 116 A, 7400 Merton Minter Blvd, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Meyer', 'Affiliation': 'Department of Veterans Affairs VISN 17 Center of Excellence for Research on Returning War Veterans, Waco, TX, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Mental Health, South Texas Veterans Healthcare System, 116 A, 7400 Merton Minter Blvd, San Antonio, TX, 78229, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Roache', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}]",Military Medical Research,['10.1186/s40779-020-00278-0']
2091,33034421,"An open-label, randomized crossover study to evaluate the acceptability and preference for contraceptive options in female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose).","INTRODUCTION


Young women in Southern Africa have extremely high HIV incidence rates necessitating the availability of female-controlled prevention methods. Understanding adolescent preference for seeking contraception would improve our understanding of acceptability, feasibility and adherence to similar modes of delivery for HIV prevention.
METHODS


UChoose was an open-label randomized crossover study over 32 weeks which aimed to evaluate the acceptability and preference for contraceptive options in healthy, HIV-uninfected, female adolescents aged 15 to 19 years, as a proxy for similar HIV prevention methods. Participants were assigned to a contraceptive method for a period of 16 weeks in the form of a bi-monthly injectable contraceptive, monthly vaginal Nuvaring ®  or daily combined oral contraceptive (COC) and then asked to state their preference. At 16 weeks, participants crossed over to another contraceptive method, to ensure that all participants tried the Nuvaring ®  (least familiar modality) and additionally, either the injection or COC. Primary outcomes were contraceptive acceptability and preference. At the end of the 32 weeks they were also asked to imagine their preference for an HIV prevention modality. Secondary endpoints included changes in sexual behaviour, contraceptive adherence and preference for biomedical and behavioural HIV prevention methods.
RESULTS


Of the 180 participants screened, 130 were enrolled and randomized to the Nuvaring ®  (n = 45), injection (n = 45) or COC (n = 40). Significantly more Nuvaring ®  users (24/116; 20.7%) requested to change to another contraceptive option compared to injection (1/73; 1.4% p = 0.0002) and COC users (4/49; 8% p = 0.074). Of those that remained on the Nuvaring ®  , adherence was significantly higher than to COC (p < 0.0001). Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring ®  (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034). Overall, the preferred contraceptive choice was injection, followed by the ring and lastly the pill.
CONCLUSIONS


Adherence to daily COC was difficult for adolescents in this cohort and the least favoured potential HIV prevention option. While some preferred vaginal ring use, these data suggest that long-acting injectables would be the preferred prevention method for adolescent girls and young women. This study highlights the need for additional options for HIV prevention in youth.",2020,Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring ®  (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034).,"['Young women in Southern Africa', 'HIV prevention in youth', 'female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose', '180 participants screened, 130 were enrolled and randomized to the Nuvaring ®  (n\xa0=\xa045), injection (n\xa0=\xa045) or', 'healthy, HIV-uninfected, female adolescents aged 15 to 19\xa0years, as a proxy for similar HIV prevention methods', 'adolescent girls and young women']","['COC', 'bi-monthly injectable contraceptive, monthly vaginal Nuvaring ®  or daily combined oral contraceptive (COC']","['acceptability and preference', 'changes in sexual behaviour, contraceptive adherence and preference for biomedical and behavioural HIV prevention methods', 'contraceptive acceptability and preference']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001746', 'cui_str': 'Southern Africa'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C1744678', 'cui_str': 'NuvaRing'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C1744678', 'cui_str': 'NuvaRing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",130.0,0.0785338,Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring ®  (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034).,"[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Gill', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Anna-Ursula', 'Initials': 'AU', 'LastName': 'Happel', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Pidwell', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mendelsohn', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Menna', 'Initials': 'M', 'LastName': 'Duyver', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'Centre for Infectious Diseases Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': 'Centre for Infectious Diseases Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Slack', 'Affiliation': 'HIV AIDS Vaccines Ethics Group, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Strode', 'Affiliation': 'HIV AIDS Vaccines Ethics Group, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Mendel', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Fynn', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wallace', 'Affiliation': 'Cancer Association of South Africa, Johannesburg, South Africa.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Spiegel', 'Affiliation': 'Department of Health and Human Services, Kelly Government Solutions, Contractor to National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Jaspan', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jo-Ann', 'Initials': 'JA', 'LastName': 'Passmore', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Hosek', 'Affiliation': 'Stroger Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Dionne', 'Initials': 'D', 'LastName': 'Smit', 'Affiliation': 'MSD (Pty) Ltd, Halfway House, South Africa.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rinehart', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}]",Journal of the International AIDS Society,['10.1002/jia2.25626']
2092,33032123,"The effect of emergency manuals on team performance during two different simulated perioperative crises: A prospective, randomized controlled trial.","STUDY OBJECTIVE


Whether having an emergency manual (EM) available for use during perioperative crises enhances or detracts from team performance, especially for multi-factorial diagnostic situations that do not explicitly match a chapter of the EM.
DESIGN


A simulation-based, prospective randomized trial based upon two perioperative crises, one involving a patient with a transfusion reaction for which the EM contains a specific chapter, and the other involving a patient with refractory hypotension progressing into septic shock for which the EM does not have a specific chapter.
SETTING


52 regularly scheduled 6-h courses at the Center for Medical Simulation in Boston, Massachusetts, USA.
STUDY GROUP


304 US-trained practicing anesthesiologists.
INTERVENTIONS


The absence or presence of the EM during the simulation case.
MEASUREMENTS


Teams were rated in the following categories: primary underlying diagnosis, fluid resuscitation, treatment of primary diagnosis, cardiac arrest management, overall crisis management, and (if applicable) EM usage. Also, raters recorded free-text 'field notes' about the usage-patterns and perceived utility of the EM. Using these 'field notes' and a two-stage, inductively revised procedure, two independent reviewers examined a subset of case videos for action analysis.
MAIN RESULTS


Performance ratings for a total of 51 teams and 95 simulations were included in the final analysis. No effect on performance was demonstrated with providing the EM in either the refractory hypotension/septic shock case or the transfusion reaction case, with the exception of the PEA arrest category. In the subset of simulations in which resuscitation from PEA arrest performance could be evaluated, EM availability was associated with an adjusted mean 1.3 point (99% confidence interval [CI]: 0.2, 2.4) improvement in performance in the transfusion reaction case (p = 0.004), but only an adjusted mean 0.2 point (99% CI, -0.7, 1.1) improvement in the refractory hypotension/septic shock case (p = 0.530) (p for interaction = 0.069). Analysis of actions found that when available, the EM was usually used, but often not until after cardiac arrest had occurred. In some cases, teams persisted with incorrect diagnoses and treatments irrespective of the presence or absence of an EM.
CONCLUSIONS


Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist. A suggestion of improved cardiac arrest resuscitation with the availability of an EM was found, but should be interpreted with caution given a limited sample size. Observed actions using the EM demonstrated that only about half of the teams used the EM to any substantive degree and most used it relatively late in the crisis. By observation, the EM appeared to be helpful in about half of the cases and did not, by itself, deter from appropriate management.",2020,"Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist.","['patient with a transfusion reaction for which the EM contains a specific chapter, and the other involving a patient with refractory hypotension progressing into septic shock for which the EM does not have a specific chapter', 'two different simulated perioperative crises', '52']",[],"['diagnosis, fluid resuscitation, treatment of primary diagnosis, cardiac arrest management, overall crisis management, and (if applicable) EM usage', 'refractory hypotension/septic shock case', 'EM availability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0274435', 'cui_str': 'Blood transfusion reaction'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4304283', 'cui_str': 'Refractory hypotension'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}]",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C1272460', 'cui_str': 'Not applicable'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C4304283', 'cui_str': 'Refractory hypotension'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]",52.0,0.125845,"Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist.","[{'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Urman', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America; Center for Perioperative Research, Brigham and Women's Hospitals, Boston, MA, United States of America. Electronic address: rurman@bwh.harvard.edu.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'August', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Chung', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Amanda H', 'Initials': 'AH', 'LastName': 'Jiddou', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Buckley', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Kara G', 'Initials': 'KG', 'LastName': 'Fields', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'J Bradley', 'Initials': 'JB', 'LastName': 'Morrison', 'Affiliation': 'Brandeis International Business School, Waltham, MA, United States of America.'}, {'ForeName': 'Janice C', 'Initials': 'JC', 'LastName': 'Palaganas', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raemer', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110080']
2093,33032163,"Recovery using ""float"" from high intensity stress on growth hormone-like molecules in resistance trained men.","OBJECTIVE


The purpose of this study was to examine the influence of a novel ""floatation-restricted environmental stimulation therapy"" (floatation-REST) on growth hormone responses to an intense resistance exercise stress.
DESIGN


Nine resistance trained men (age: 23.4 ± 2.5 yrs.; height: 175.3 ± 5.4 cm; body mass: 85.3 ± 7.9 kg) completed a balanced, crossover-controlled study design with two identical exercise trials, differing only in post-exercise recovery intervention (i.e., control or floatation-REST). A two-week washout period was used between experimental conditions. Plasma lactate was measured pre-exercise, immediately post-exercise and after the 1 h. recovery interventions. Plasma iGH was measured pre-exercise, immediately-post exercise, and after the recovery intervention, as well as 24 h and 48 h after the exercise test. The bGH-L was measured only at pre-exercise and following each recovery intervention.
RESULTS


For both experimental conditions, a significant (P ≤ 0.05) increase in lactate concentrations were observed immediately post-exercise (~14 mmol • L-1) and remained slightly elevated after the recovery condition. The same pattern of responses was observed for iGH with no differences from resting values at 24 and 48 h of recovery. The bGH-L showed no exercise-induced changes following recovery with either treatment condition, however concentration values were dramatically lower than ever reported.
CONCLUSION


The use of floatation-REST therapy immediately following intense resistance exercise does not appear to influence anterior pituitary function in highly resistance trained men. However, the lower values of bGH suggest dramatically different molecular processing mechanisms at work in this highly trained population.",2020,"For both experimental conditions, a significant (P ≤ 0.05) increase in lactate concentrations were observed immediately post-exercise (","['Nine resistance trained men (age: 23.4\u202f±\u202f2.5\u202fyrs', '14', ' height: 175.3\u202f±\u202f5.4\u202fcm; body mass: 85.3\u202f±\u202f7.9\u202fkg', 'highly resistance trained men', 'resistance trained men']","['novel ""floatation-restricted environmental stimulation therapy"" (floatation-REST', 'floatation-REST therapy', 'exercise recovery intervention (i.e., control or floatation-REST']","['Plasma iGH', 'bGH-L', 'Plasma lactate', 'lactate concentrations', 'concentration values']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0017351', 'cui_str': 'Immunoglobulin gene GM allotype'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",9.0,0.0688166,"For both experimental conditions, a significant (P ≤ 0.05) increase in lactate concentrations were observed immediately post-exercise (","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kraemer', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America. Electronic address: kraemer.44@osu.edu.'}, {'ForeName': 'Lydia K', 'Initials': 'LK', 'LastName': 'Caldwell', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Post', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Beeler', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Dickerson', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kennett', 'Affiliation': 'Department of Veterinary and Biomedical Sciences, The Pennsylvania State University, University Park, PA 16802, United States of America.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Volek', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Carl M', 'Initials': 'CM', 'LastName': 'Maresh', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Wesley C', 'Initials': 'WC', 'LastName': 'Hymer', 'Affiliation': 'Department of Biochemistry and Molecular Biology, The Pennsylvania State University, University Park, PA 16802, United States of America.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101355']
2094,33032164,"Exploring the impact of a liquefied petroleum gas intervention on time use in rural Peru: A mixed methods study on perceptions, use, and implications of time savings.","BACKGROUND


Efforts to promote clean cooking through adoption of clean-burning fuels such as liquefied petroleum gas (LPG) are often based on the idea that near-exclusive use of LPG could lead to health improvements. However, benefits beyond health, such as time savings, could be more tangible and meaningful to LPG users.
OBJECTIVES


This study investigated the effect of an LPG intervention on time spent cooking and collecting fuel, using objective measures of stove temperatures combined with self-reports under conditions of near-exclusive LPG use. We also investigated the perceived value of any time savings and potential economic and quality of life implications.
METHODS


We analyzed data from the Cardiopulmonary outcomes and Household Air Pollution trial in Puno, Peru, a randomized controlled trial with 180 participants assessing exposure and health impacts of an LPG stove, fuel, and behavioral intervention. Surveys conducted with 90 intervention women receiving free LPG and 90 control women cooking primarily with biomass assessed time spent cooking and collecting biomass fuel and use of time savings. Cooking time was objectively measured with temperature sensors on all stoves. Qualitative interviews explored perceptions and use of time savings in more depth.
RESULTS


Intervention women spent 3.2 fewer hours cooking and 1.9 fewer hours collecting fuel per week compared to control women, but cooked on average 1.0 more meals per day. Participants perceived time saved from LPG positively, reporting more time for household chores, leisure activities, and activities with income-generating potential such as caring for animals and working in fields.
DISCUSSION


This paper suggests that the benefits of LPG extend beyond health and the environment. LPG use could also lead to economic and quality of life gains, through increased time for work, rest, and consumption of hot meals, and reduced arduous biomass fuel collection.",2020,"RESULTS


Intervention women spent 3.2 fewer hours cooking and 1.9 fewer hours collecting fuel per week compared to control women, but cooked on average 1.0 more meals per day.","['180 participants assessing exposure and health impacts of an LPG stove, fuel, and behavioral intervention', '90 intervention women receiving free LPG and 90 control women cooking primarily with biomass assessed', 'rural Peru']","['LPG', 'liquefied petroleum gas intervention', 'LPG intervention']","['time for work, rest, and consumption of hot meals, and reduced arduous biomass fuel collection', 'time spent cooking and collecting biomass fuel and use of time savings', 'time saved from LPG positively, reporting more time for household chores, leisure activities, and activities with income-generating potential such as caring for animals and working in fields', 'Cooking time', 'time savings and potential economic and quality of life implications']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0336754', 'cui_str': 'Stove'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0031238', 'cui_str': 'Peru'}]","[{'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0023292', 'cui_str': 'Leisure Activities'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",180.0,0.0503954,"RESULTS


Intervention women spent 3.2 fewer hours cooking and 1.9 fewer hours collecting fuel per week compared to control women, but cooked on average 1.0 more meals per day.","[{'ForeName': 'Kendra N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA. Electronic address: kendra.williams@jhu.edu.'}, {'ForeName': 'Josiah L', 'Initials': 'JL', 'LastName': 'Kephart', 'Affiliation': 'Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA; Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Fandiño-Del-Rio', 'Affiliation': 'Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA; Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Simkovich', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Koehler', 'Affiliation': 'Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Harvey', 'Affiliation': 'Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Environment international,['10.1016/j.envint.2020.105932']
2095,33032168,COPDCompEx: A novel composite endpoint for COPD exacerbations to enable faster clinical development.,"BACKGROUND


Frequency of moderate and severe chronic obstructive pulmonary disease exacerbations is an important endpoint in clinical trials, but makes them large and lengthy when powered to evaluate it. We aimed to develop a composite endpoint (COPDCompEx) that could predict treatment effect on exacerbations, enabling the design of shorter early phase clinical trials requiring fewer patients.
METHODS


In this post hoc analysis, data from 20 randomized controlled trials were used to develop and test COPDCompEx. Diary events were tested against predefined threshold values for peak expiratory flow, reliever medication use, and symptoms. A COPDCompEx event was defined as first occurrence of a diary event, a moderate or severe exacerbation, or a study dropout. Ratios of event frequency, treatment effect and future trial sample size were compared between COPDCompEx and moderate and severe exacerbations.
FINDINGS


At 3 months, the proportion of patients experiencing COPDCompEx events increased over 3-fold versus exacerbations alone. All components contributed to COPDCompEx event rate. Treatment effects at 3 months were closely matched between COPDCompEx and exacerbations, and the large net gain in power substantially reduced the required sample size.
INTERPRETATION


COPDCompEx may be used to predict treatment effect on moderate and severe exacerbations of chronic obstructive pulmonary disease. This may enable the design of shorter Phase 2 clinical trials requiring fewer patients when compared with current exacerbation studies, with exacerbations as a key Phase 3 endpoint. This would, therefore, allow more efficient decision-making with reduced burden and risk to study participants.",2020,"Treatment effects at 3 months were closely matched between COPDCompEx and exacerbations, and the large net gain in power substantially reduced the required sample size.
",['moderate and severe chronic obstructive pulmonary disease exacerbations'],['COPDCompEx'],"['peak expiratory flow, reliever medication use, and symptoms', 'proportion of patients experiencing COPDCompEx events']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}]",[],"[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.362478,"Treatment effects at 3 months were closely matched between COPDCompEx and exacerbations, and the large net gain in power substantially reduced the required sample size.
","[{'ForeName': 'Claus F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-Universität Marburg, Marburg, Germany, Member of the German Center for Lung Research (DZL).'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Fuhlbrigge', 'Affiliation': 'Pulmonary Sciences and Critical Care, Department of Medicine, University of Colorado School of Medicine, Denver, CO, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Jauhiainen', 'Affiliation': 'AstraZeneca, BioPharma Early Biometrics and Statistical Innovation, Data Science & AI, BioPharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Lieke E J M', 'Initials': 'LEJM', 'LastName': 'Scheepers', 'Affiliation': 'AstraZeneca, BioPharma Early Biometrics and Statistical Innovation, Data Science & AI, BioPharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bengtsson', 'Affiliation': 'StatMind Statistical and Mathematical Modelling, Innovation and Design AB, Lund, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Peterson', 'Affiliation': 'StatMind Statistical and Mathematical Modelling, Innovation and Design AB, Lund, Sweden.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Karlsson', 'Affiliation': 'AstraZeneca, BioPharmaceuticals Medical, Gothenburg, Sweden.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Sethi', 'Affiliation': 'Emeritus Professor Respiratory Medicine, Kings College, London, UK; Galecto Biotech, London, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Locantore', 'Affiliation': 'GlaxoSmithKline R&D, Medical Innovation Value Evidence and Outcomes, Collegeville, PA, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Tal-Singer', 'Affiliation': 'GlaxoSmithKline R&D, Medical Innovation Value Evidence and Outcomes, Collegeville, PA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Rennard', 'Affiliation': 'AstraZeneca, BioPharmaceuticals R&D, Cambridge, UK.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Fagerås', 'Affiliation': 'AstraZeneca, BioPharmaceuticals Medical, Gothenburg, Sweden.'}, {'ForeName': 'Carla A', 'Initials': 'CA', 'LastName': 'Da Silva', 'Affiliation': 'AstraZeneca, Early Respiratory & Immunology (R&I) Clinical Development, BioPharmaceuticals R&D, Gothenburg, Sweden. Electronic address: Carla.DaSilva@astrazeneca.com.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106175']
2096,33036660,Expected impact of MRI-related interreader variability on ProScreen prostate cancer screening trial: a pre-trial validation study.,"BACKGROUND


The aim of this study is to investigate the potential impact of prostate magnetic resonance imaging (MRI) -related interreader variability on a population-based randomized prostate cancer screening trial (ProScreen).
METHODS


From January 2014 to January 2018, 100 men aged 50-63 years with clinical suspicion of prostate cancer (PCa) in Helsinki University Hospital underwent MRI. Nine radiologists individually reviewed the pseudonymized MRI scans of all 100 men in two ProScreen trial centers. All 100 men were biopsied according to a histological composite variable comprising radical prostatectomy histology (N = 38) or biopsy result within 1 year from the imaging (N = 62). Fleiss' kappa (κ) was used to estimate the combined agreement between all individual radiologists. Sample data were subsequently extrapolated to 1000-men subgroups of the ProScreen cohort.
RESULTS


Altogether 89% men of the 100-men sample were diagnosed with PCa within a median of 2.4 years of follow-up. Clinically significant PCa (csPCa) was identified in 76% men. For all PCa, mean sensitivity was 79% (SD ±10%, range 62-96%), and mean specificity 60% (SD ±22%, range 27-82%). For csPCa (Gleason Grade 2-5) MRI was equally sensitive (mean 82%, SD ±9%, range 67-97%) but less specific (mean 47%, SD ±20%, range 21-75%). Interreader agreement for any lesion was fair (κ 0.40) and for PI-RADS 4-5 lesions it was moderate (κ 0.60). Upon extrapolating these data, the average sensitivity and specificity to a screening positive subgroup of 1000 men from ProScreen with a 30% prevalence of csPCa, 639 would be biopsied. Of these, 244 men would be true positive, and 395 false positive. Moreover, 361 men would not be referred to biopsy and among these, 56 csPCas would be missed. The variation among the radiologists was broad as the least sensitive radiologist would have twice as many men biopsied and almost three times more men would undergo unnecessary biopsies. Although the most sensitive radiologist would miss only 2.6% of csPCa (false negatives), the least sensitive radiologist would miss every third.
CONCLUSIONS


Interreader agreement was fair to moderate. The role of MRI in the ongoing ProScreen trial is crucial and has a substantial impact on the screening process.",2020,"For csPCa (Gleason Grade 2-5) MRI was equally sensitive (mean 82%, SD ±9%, range 67-97%) but less specific (mean 47%, SD ±20%, range 21-75%).","['From January 2014 to January 2018, 100 men aged 50-63\u2009years with clinical suspicion of prostate cancer (PCa) in Helsinki University Hospital underwent MRI', '244 men would be true positive, and 395 false positive', 'Nine radiologists individually reviewed the pseudonymized MRI scans of all 100 men in two ProScreen trial centers', 'Altogether 89% men of the 100-men sample were diagnosed with PCa within a median of 2.4\u2009years of follow-up', 'All 100 men were biopsied according to a histological composite variable comprising radical prostatectomy histology (N\u2009=\u200938) or biopsy result within 1 year from the imaging (N\u2009=\u200962', '361 men would not be referred to biopsy and among these, 56 csPCas would be missed']",['prostate magnetic resonance imaging (MRI) -related'],"['Clinically significant PCa (csPCa', 'mean sensitivity']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0205559', 'cui_str': 'True positive'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",100.0,0.0652677,"For csPCa (Gleason Grade 2-5) MRI was equally sensitive (mean 82%, SD ±9%, range 67-97%) but less specific (mean 47%, SD ±20%, range 21-75%).","[{'ForeName': 'Ronja', 'Initials': 'R', 'LastName': 'Hietikko', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, PL900, 00029 HUS, Helsinki, Finland. Ronja.hietikko@hus.fi.'}, {'ForeName': 'Tuomas P', 'Initials': 'TP', 'LastName': 'Kilpeläinen', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, PL900, 00029 HUS, Helsinki, Finland.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Kenttämies', 'Affiliation': 'Research Program in Systems Oncology, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Ronkainen', 'Affiliation': 'Department of Radiology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Ijäs', 'Affiliation': 'HUS Diagnostic Center, HUS Medical Imaging Center / Radiology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Lind', 'Affiliation': 'HUS Diagnostic Center, HUS Medical Imaging Center / Radiology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Marjasuo', 'Affiliation': 'HUS Diagnostic Center, HUS Medical Imaging Center / Radiology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Oksala', 'Affiliation': 'Department of Radiology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Oksanen', 'Affiliation': 'HUS Diagnostic Center, HUS Medical Imaging Center / Radiology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Tuomas', 'Initials': 'T', 'LastName': 'Saarinen', 'Affiliation': 'Department of Radiology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Ritja', 'Initials': 'R', 'LastName': 'Savolainen', 'Affiliation': 'HUS Diagnostic Center, HUS Medical Imaging Center / Radiology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, PL900, 00029 HUS, Helsinki, Finland.'}, {'ForeName': 'Teuvo L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Tuomas', 'Initials': 'T', 'LastName': 'Mirtti', 'Affiliation': 'Research Program in Systems Oncology, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Natunen', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Rannikko', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, PL900, 00029 HUS, Helsinki, Finland.'}]",Cancer imaging : the official publication of the International Cancer Imaging Society,['10.1186/s40644-020-00351-w']
2097,33036661,Efficacy of one-stage cartilage repair using allogeneic mesenchymal stromal cells and autologous chondron transplantation (IMPACT) compared to nonsurgical treatment for focal articular cartilage lesions of the knee: study protocol for a crossover randomized controlled trial.,"BACKGROUND


Articular cartilage defects in the knee have poor intrinsic healing capacity and may lead to functional disability and osteoarthritis (OA). ""Instant MSC Product accompanying Autologous Chondron Transplantation"" (IMPACT) combines rapidly isolated recycled autologous chondrons with allogeneic MSCs in a one-stage surgery. IMPACT was successfully executed in a first-in-man investigator-driven phase I/II clinical trial in 35 patients. The purpose of this study is to compare the efficacy of IMPACT to nonsurgical treatment for the treatment of large (2-8 cm 2 ) articular cartilage defects in the knee.
METHODS


Sixty patients will be randomized to receive nonsurgical care or IMPACT. After 9 months of nonsurgical care, patients in the control group are allowed to receive IMPACT surgery. The Knee Injury and Osteoarthritis Outcome Score (KOOS), pain (numeric rating scale, NRS), and EuroQol five dimensions five levels (EQ5D-5 L) will be used to compare outcomes at baseline and 3, 6, 9, 12, and 18 months after inclusion. Cartilage formation will be assessed at baseline, and 6 and 18 months after inclusion using MRI. An independent rheumatologist will monitor the onset of a potential inflammatory response. (Severe) adverse events will be recorded. Lastly, the difference between IMPACT and nonsurgical care in terms of societal costs will be assessed by monitoring healthcare resource use and productivity losses during the study period. A health economic model will be developed to estimate the incremental cost-effectiveness ratio of IMPACT vs. nonsurgical treatment in terms of costs per quality adjusted life year over a 5-year time horizon.
DISCUSSION


This study is designed to evaluate the efficacy of IMPACT compared to nonsurgical care. Additionally, safety of IMPACT will be assessed in 30 to 60 patients. Lastly, this study will evaluate the cost-effectiveness of IMPACT compared to nonsurgical care.
TRIAL REGISTRATION


NL67161.000.18 [Registry ID: CCMO] 2018#003470#27 [EU-CTR; registered on 26 March 2019] NCT04236739 [ ClinicalTrials.gov ] [registered after start of inclusion; 22 January 2020].",2020,"The Knee Injury and Osteoarthritis Outcome Score (KOOS), pain (numeric rating scale, NRS), and EuroQol five dimensions five levels (EQ5D-5 L) will be used to compare outcomes at baseline and 3, 6, 9, 12, and 18 months after inclusion.","['large (2-8\u2009cm 2 ) articular cartilage defects in the knee', '26 March 2019', '30 to 60 patients', 'focal articular cartilage lesions of the knee', 'Sixty patients']","['Instant MSC Product accompanying Autologous Chondron Transplantation"" (IMPACT', 'nonsurgical care or IMPACT', 'IMPACT', 'one-stage cartilage repair using allogeneic mesenchymal stromal cells and autologous chondron transplantation (IMPACT', 'IMPACT surgery']","['Knee Injury and Osteoarthritis Outcome Score (KOOS), pain (numeric rating scale, NRS), and EuroQol five dimensions five levels (EQ5D-5\u2009L', 'Cartilage formation']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0410334', 'cui_str': 'Defect of articular cartilage'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0007303', 'cui_str': 'Structure of articular cartilage'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1112785', 'cui_str': 'Cartilage repair'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0598067', 'cui_str': 'Cartilage formation'}]",35.0,0.160665,"The Knee Injury and Osteoarthritis Outcome Score (KOOS), pain (numeric rating scale, NRS), and EuroQol five dimensions five levels (EQ5D-5 L) will be used to compare outcomes at baseline and 3, 6, 9, 12, and 18 months after inclusion.","[{'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Korpershoek', 'Affiliation': 'Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Vonk', 'Affiliation': 'Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.'}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Kester', 'Affiliation': 'Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.'}, {'ForeName': 'L B', 'Initials': 'LB', 'LastName': 'Creemers', 'Affiliation': 'Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.'}, {'ForeName': 'T S', 'Initials': 'TS', 'LastName': 'de Windt', 'Affiliation': 'Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.'}, {'ForeName': 'M M A', 'Initials': 'MMA', 'LastName': 'Kip', 'Affiliation': 'Department of Health Technology and Services Research, Technical Medical Centre, University of Twente, Technohal, Hallenweg 5, 7522, NH, Enschede, The Netherlands.'}, {'ForeName': 'D B F', 'Initials': 'DBF', 'LastName': 'Saris', 'Affiliation': 'Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.'}, {'ForeName': 'R J H', 'Initials': 'RJH', 'LastName': 'Custers', 'Affiliation': 'Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands. r.j.h.custers@umcutrecht.nl.'}]",Trials,['10.1186/s13063-020-04771-8']
2098,33036662,Effects of Ginger on clinical manifestations and paraclinical features of patients with Severe Acute Respiratory Syndrome due to COVID-19: A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES


We investigate the effects of Ginger, compared to the usual therapeutic regimen on clinical manifestations and paraclinical features in patients with confirmed COVID-19 that are moderately ill.
TRIAL DESIGN


This is a single center, randomized, double-blind, placebo-controlled clinical trial with parallel group design.
PARTICIPANTS


Inclusion criteria: 1. Patients admitted to Severe Acute Respiratory Syndrome (SARS) Departments at Shahid Mohammadi Hospital, Bandar Abbas, Iran 2. Age ≥18 years (weight ≥35 kg) 3. Hospitalized ≤48 hours 4. Confirmed SARS-CoV-2 diagnosis (Positive polymerase chain reaction (PCR)) 5. Moderate pneumonia and lung involvement in imaging 6. Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm Exclusion criteria: 1. Underlying diseases, including heart disease, chronic hypertension, severe renal failure, severe liver failure, and thyroid disorders 2. Use of warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids, and antiarrhythmic drugs 3. Severe and critical pneumonia 4. History of known allergy to Ginger 5. Pregnancy and breastfeeding INTERVENTION AND COMPARATOR: Intervention group: The standard treatment regimen for COVID-19 along with Ginger-based herbal tablets (Vomigone ®, Dineh Pharmaceutical Company, Iran) at a dose of 1000 mg three times a day for a period of seven days.
CONTROL GROUP


The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education's protocol, along with Vomigone-like placebo tablets (Dineh Pharmaceutical Company, Iran) at a dose of two tablets three times a day for a period of seven days.
MAIN OUTCOMES


The primary outcome is recovery rate of clinical symptoms, including fever, dry cough, tiredness, and GI symptoms as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein within seven days of randomization. Time to improvement of clinical and paraclinical features along with the incidence of serious adverse events are the secondary outcomes within seven days of randomization.
RANDOMIZATION


An interactive web-based system will be used to allocate eligible participants, based on the inclusion and exclusion criteria, to one of the two study arms (in a 1:1 ratio) using block randomization.
BLINDING (MASKING)


All study participants, research coordinators, clinicians, nurses, and investigators will be blinded to the group assignment.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


A total of 84 participants will be randomized into two groups of 42 patients.
TRIAL STATUS


The protocol is Version 1.0, May 23, 2020. Recruitment began July 21, 2020, and is anticipated to be completed by October 30, 2020.
TRIAL REGISTRATION


This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is "" IRCT20200506047323N1 "". Registration date is 23 May 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"The primary outcome is recovery rate of clinical symptoms, including fever, dry cough, tiredness, and GI symptoms as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein within seven days of randomization.","['patients with Severe Acute Respiratory Syndrome due to COVID-19', 'patients with confirmed COVID-19 that are moderately ill', '84 participants will be randomized into two groups of 42 patients', 'Patients admitted to Severe Acute Respiratory Syndrome (SARS) Departments at Shahid Mohammadi Hospital, Bandar Abbas, Iran 2', 'Age ≥18 years (weight ≥35 kg']","['Ginger', 'standard treatment regimen for COVID-19 along with Ginger-based herbal tablets (Vomigone ®, Dineh Pharmaceutical Company, Iran', 'placebo', 'warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids', 'GROUP']","['recovery rate of clinical symptoms, including fever, dry cough, tiredness, and GI symptoms as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein', 'heart disease, chronic hypertension, severe renal failure, severe liver failure', 'Moderate pneumonia and lung involvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1175175', 'cui_str': 'Severe acute respiratory syndrome'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0162751', 'cui_str': 'Ginger'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0026457', 'cui_str': 'Monoamine oxidase inhibitor'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0850149', 'cui_str': 'Dry cough'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]",84.0,0.405155,"The primary outcome is recovery rate of clinical symptoms, including fever, dry cough, tiredness, and GI symptoms as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein within seven days of randomization.","[{'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Safa', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hassaniazad', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farashahinejad', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Parivash', 'Initials': 'P', 'LastName': 'Davoodian', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Dadvand', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Hassanipour', 'Affiliation': 'Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fathalipour', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. M.fathalipour@hums.ac.ir.'}]",Trials,['10.1186/s13063-020-04765-6']
2099,33036670,Percutaneous Coronary Intervention for Left Main Coronary Artery Bifurcation Lesions: Two-stent versus one-stent Strategy for Comparison of 6-month MACE.,"OBJECTIVE


To assess the short term clinical outcomes for a single-stent (SS) strategy versus a double-stent (DS) strategy in percutaneous coronary intervention (PCI) of distal unprotected left main coronary artery (ULMCA) lesions.
STUDY DESIGN


Descriptive comparative study.
PLACE AND DURATION OF STUDY


Armed Forces Institute of Cardiology, Rawalpindi, Pakistan from January 2017 to April 2018.
METHODOLOGY


SS treatment was defined as stenting of the main branch alone and DS treatment as stenting of both the main and side branches. Patients who underwent LMCA PCI were recruited in the study using consecutive sampling. Crossover technique, with or without kissing balloon (KB) dilatation, was employed in those getting PCI with a SS strategy; whereas, DK crush, mini-crush , culotte and T-stenting techniques were used in patients undergoing PCI with a DS strategy. The primary endpoints were a composite of major adverse cardiovascular event (MACE) i.e. myocardial infarction, stroke or death and target lesion revascularisation (TLR).
RESULTS


A total of 103 patients were recruited in the study; out of which, 73 underwent LMCA PCI employing a SS technique; whereas, 30 of them were treated with a DS strategy. Mean age of the study participants was 63.2 ±10.6 years.  The procedural success rate was 100% in both groups. There was a lower frequency of MACE with single-stent strategy (4.1%) versus the double-stent strategy (16.7%, p=0.031) during the 6-month follow-up period.
CONCLUSION


In comparison to the two-stent strategy of ULMCA bifurcation intervention, a single-stent approach seems to show favourable clinical outcomes and 6-month MACE-free survival. The choice of optimal revascularisation technique proves to be important for the prognosis; therefore, it requires pragmatic decision-making.   Key Words: PCI (percutaneous coronary intervention), ULMCA (unprotected left main coronary artery), SS (single-stent), DS (double-stent), MACE (major adverse cardiovascular events), CABG (cardiopulmonary bypass grafting), TLR (target lesion revascularisation).",2020,"The primary endpoints were a composite of major adverse cardiovascular event (MACE) i.e. myocardial infarction, stroke or death and target lesion revascularisation (TLR).
","['Mean age of the study participants was 63.2 ±10.6 years', 'patients undergoing PCI with a DS strategy', 'Patients who underwent LMCA PCI', 'percutaneous coronary intervention (PCI) of distal unprotected left main coronary artery (ULMCA) lesions', 'A total of 103 patients were recruited in the study; out of which, 73 underwent']","['LMCA PCI employing a SS technique', 'Crossover technique, with or without kissing balloon (KB) dilatation', 'PCI (percutaneous coronary intervention), ULMCA (unprotected left main coronary artery), SS (single-stent), DS (double-stent), MACE', 'single-stent (SS) strategy versus a double-stent (DS) strategy', 'Percutaneous Coronary Intervention']","['procedural success rate', 'composite of major adverse cardiovascular event (MACE) i.e. myocardial infarction, stroke or death and target lesion revascularisation (TLR']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C2828271', 'cui_str': 'Levomefolate calcium'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517526', 'cui_str': '103'}]","[{'cui': 'C2828271', 'cui_str': 'Levomefolate calcium'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0233926', 'cui_str': 'Kissing'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",103.0,0.0494855,"The primary endpoints were a composite of major adverse cardiovascular event (MACE) i.e. myocardial infarction, stroke or death and target lesion revascularisation (TLR).
","[{'ForeName': 'Mubarra', 'Initials': 'M', 'LastName': 'Nasir', 'Affiliation': 'Armed Forces Institute of Cardiology, Rawalpindi, Pakistan.'}, {'ForeName': 'Hafiz Muhammad', 'Initials': 'HM', 'LastName': 'Shafique', 'Affiliation': 'Armed Forces Institute of Cardiology, Rawalpindi, Pakistan.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'Armed Forces Institute of Cardiology, Rawalpindi, Pakistan.'}, {'ForeName': 'Farhan', 'Initials': 'F', 'LastName': 'Tuyyab', 'Affiliation': 'Armed Forces Institute of Cardiology, Rawalpindi, Pakistan.'}, {'ForeName': 'Sohail', 'Initials': 'S', 'LastName': 'Aziz', 'Affiliation': 'Armed Forces Institute of Cardiology, Rawalpindi, Pakistan.'}, {'ForeName': 'Rehana', 'Initials': 'R', 'LastName': 'Khadim', 'Affiliation': ''}]",Journal of the College of Physicians and Surgeons--Pakistan : JCPSP,['10.29271/jcpsp.2020.09.894']
2100,33042940,Use of a Spinal Thermal Massage Device for Anti-oxidative Function and Pain Alleviation.,"Background:  Elderly people are vulnerable to a variety of diseases, including chronic pain, which reduces their levels of physical fitness. Thermal massage has been shown to relieve pain and activate antioxidant enzymes. The objective of this study was to determine whether thermal massaging of the spinal column can reduce muscle pain and induce antioxidant function.  Methods:  This study included participants aged ≥60 years with lower back pain. The participants were assigned to either an experimental group who received spinal column thermal massage and standard rehabilitative treatment or a control group who received standard rehabilitative treatment only. Data from a total of 116 participants (61 and 55 in the control and experimental groups, respectively) were used for analysis. Participants were assessed before treatment and at 4 (POST1) and 8 weeks (POST2) post-treatment, using a pain numeric rating scale (PNRS) and the Roland and Morris Disability Questionnaire (RMDQ), and by measuring the serum levels of superoxide dismutase (SOD), serum glutathione-peroxidase (GPx), and serum catalase (CAT).  Results:  The extent of pain reduction, as measured by the PNRS, was greater in the experimental group. The RMDQ score in the control group decreased at POST1, but the decrease was not maintained at POST2, whereas the decrease in POST1 in the experimental group continued until POST2. SOD concentrations were significantly higher in the experimental group at POST1 and POST2, and GPx levels were significantly higher in the experimental group at POST2; however, there were no changes in CAT concentrations. Incidentally, there was a significant correlation between antioxidant activity and pain perception in the experimental group.  Conclusions:  The study findings suggest that spinal column thermal massage reduces pain more effectively, improves self-reported levels of disability, and increases the antioxidant enzyme levels. Thermal massage may, therefore, be useful in the prevention and treatment of diseases associated with oxidation.",2020,"SOD concentrations were significantly higher in the experimental group at POST1 and POST2, and GPx levels were significantly higher in the experimental group at POST2; however, there were no changes in CAT concentrations.","['participants aged ≥60 years with lower back pain', '116 participants (61 and 55 in the control and experimental groups, respectively) were used for analysis']","['spinal column thermal massage and standard rehabilitative treatment or a control group who received standard rehabilitative treatment only', 'Thermal massage', 'Spinal Thermal Massage Device', 'spinal column thermal massage']","['pain numeric rating scale (PNRS) and the Roland and Morris Disability Questionnaire (RMDQ), and by measuring the serum levels of superoxide dismutase (SOD), serum glutathione-peroxidase (GPx), and serum catalase (CAT', 'GPx levels', 'SOD concentrations', 'POST1', 'CAT concentrations', 'antioxidant enzyme levels', 'antioxidant activity and pain perception', 'pain reduction', 'RMDQ score']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0014440', 'cui_str': 'Enzyme measurement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",116.0,0.03926,"SOD concentrations were significantly higher in the experimental group at POST1 and POST2, and GPx levels were significantly higher in the experimental group at POST2; however, there were no changes in CAT concentrations.","[{'ForeName': 'Ka-Eun', 'Initials': 'KE', 'LastName': 'Kim', 'Affiliation': 'College of Medical Sciences, Jeonju University, Jeonju-si, South Korea.'}, {'ForeName': 'Jeong-Sook', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Department of Nursing, Nambu University, Gwangju, South Korea.'}, {'ForeName': 'Il-Young', 'Initials': 'IY', 'LastName': 'Cho', 'Affiliation': 'College of Medical Sciences, Jeonju University, Jeonju-si, South Korea.'}, {'ForeName': 'Yong-Soon', 'Initials': 'YS', 'LastName': 'Yoon', 'Affiliation': 'Department of Rehabilitation Medicine, Presbyterian (Jesus) Medical Center, Jeonju-si, South Korea.'}, {'ForeName': 'Soon-Kwon', 'Initials': 'SK', 'LastName': 'Park', 'Affiliation': 'College of Social Sciences, Jeonju University, Jeonju-si, South Korea.'}, {'ForeName': 'Sang-Yun', 'Initials': 'SY', 'LastName': 'Nam', 'Affiliation': 'College of Medical Sciences, Jeonju University, Jeonju-si, South Korea.'}]",Frontiers in public health,['10.3389/fpubh.2020.00493']
2101,33043024,Education and Message Framing Increase Willingness to Undergo Research Lumbar Puncture: A Randomized Controlled Trial.,"Reluctance to undergo lumbar puncture (LP) is a barrier to neurological disease biomarker research. We assessed whether an educational intervention increased willingness to consider research LP and whether message framing modified intervention effectiveness. We randomly assigned 851 recruitment registry enrollees who had previously indicated they were unwilling to be contacted about studies requiring LP to gain or loss framed video educational interventions describing the procedure and the probability of experiencing adverse events. The gain framed intervention emphasized the proportion of individuals free of adverse events; the loss frame emphasized the proportion experiencing adverse events. The primary outcome for the study was the participant's post-intervention agreement to be contacted about studies requiring LP. Participants were mean (SD) age 60.1 years (15.7), 69% female ( n  = 591), and mostly college educated and white. Among the 699 participants who completed the study, 43% (95% CI: 0.39, 0.47;  n  = 301) changed their response to agree to be contacted about studies requiring LP. We estimated that participants randomized to the gain framed intervention had 67% higher odds of changing their response compared to those randomized to the loss frame (Odds Ratio = 1.67; 95% CI: 1.24, 2.26;  p  < 0.001). A classification and regression tree model identified participants' pre-intervention willingness as the strongest predictor of changing response. Education, in particular education that alerts participants to the probability of not experiencing adverse events, may be an effective tool to increase participation rates in research requiring LP.",2020,"Among the 699 participants who completed the study, 43% (95% CI: 0.39, 0.47;  n  = 301) changed their response to agree to be contacted about studies requiring LP.","['699 participants who completed the study, 43% (95% CI: 0.39, 0.47;  n  = 301', 'SD) age 60.1 years (15.7), 69% female ( n  = 591), and mostly college educated and white', 'Willingness to Undergo Research Lumbar Puncture', '851 recruitment registry enrollees who had previously indicated they were unwilling to be contacted about studies requiring', 'Participants were mean']","['LP to gain or loss framed video educational interventions', 'educational intervention', 'lumbar puncture (LP']",[],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],851.0,0.105974,"Among the 699 participants who completed the study, 43% (95% CI: 0.39, 0.47;  n  = 301) changed their response to agree to be contacted about studies requiring LP.","[{'ForeName': 'Megan G', 'Initials': 'MG', 'LastName': 'Witbracht', 'Affiliation': 'Institute for Memory Impairments and Neurological Disorders, University of California, Irvine, Irvine, CA, United States.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Bernstein', 'Affiliation': 'Department of Statistics, University of California, Irvine, Irvine, CA, United States.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Lin', 'Affiliation': 'Graduate Medical Sciences, Boston University School of Medicine, Boston, MA, United States.'}, {'ForeName': 'Christian R', 'Initials': 'CR', 'LastName': 'Salazar', 'Affiliation': 'Institute for Memory Impairments and Neurological Disorders, University of California, Irvine, Irvine, CA, United States.'}, {'ForeName': 'S Ahmad', 'Initials': 'SA', 'LastName': 'Sajjadi', 'Affiliation': 'Institute for Memory Impairments and Neurological Disorders, University of California, Irvine, Irvine, CA, United States.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Hoang', 'Affiliation': 'Institute for Memory Impairments and Neurological Disorders, University of California, Irvine, Irvine, CA, United States.'}, {'ForeName': 'Chelsea G', 'Initials': 'CG', 'LastName': 'Cox', 'Affiliation': 'Institute for Memory Impairments and Neurological Disorders, University of California, Irvine, Irvine, CA, United States.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Gillen', 'Affiliation': 'Institute for Memory Impairments and Neurological Disorders, University of California, Irvine, Irvine, CA, United States.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Grill', 'Affiliation': 'Institute for Memory Impairments and Neurological Disorders, University of California, Irvine, Irvine, CA, United States.'}]",Frontiers in medicine,['10.3389/fmed.2020.00493']
2102,33043027,"Evaluation of an Objective Measurement Tool for Stress Level Reduction by Individually Chosen Music During Colonoscopy-Results From the Study ""ColoRelaxTone"".","Background and Aims:  Colonoscopy as standard procedure in endoscopy is often perceived as uncomfortable for patients. Patient's anxiety is therefore a significant issue, which often lead to avoidance of participation of relevant examinations as CRC-screening. Non-pharmacological anxiety management interventions such as music might contribute to relaxation in the phase prior and during endoscopy. Although music's anxiolytic effects have been reported previously, no objective measurement of stress level reduction has been reported yet. Focus of this study was to evaluate the objective measurement of the state of relaxation in patients undergoing colonoscopy.  Methods:  Prospective study ( n  = 196) performed at one endoscopic high-volume center. Standard colonoscopy was performed in control group. Interventional group received additionally self-chosen music over earphones. Facial Electromyography (fEMG) activity was obtained. Clinician Satisfaction with Sedation Instrument (CSSI) and Patients Satisfaction with Sedation Instrument (PSSI) was answered by colonoscopists and patients, respectively. Overall satisfaction with music accompanied colonoscopy was obtained if applicable.  Results:  Mean difference measured by fEMG via musculus zygomaticus major indicated a significantly lower stress level in the music group [7.700(±5.560) μV vs. 4.820(±3.330) μV;  p  = 0.001]. Clinician satisfaction was significantly higher with patients listening to music [82.69(±15.04) vs. 87.3(±15.02) pts.;  p  = 0.001]. Patient's satisfaction was higher but did not differ significantly.  Conclusions:  We conclude that self-chosen music contributes objectively to a reduced stress level for patients and therefore subjectively perceived satisfaction for endoscopists. Therefore, music should be considered as a non-pharmacological treatment method of distress reduction especially in the beginning of endoscopic procedures.",2020,Mean difference measured by fEMG via musculus zygomaticus major indicated a significantly lower stress level in the music group [7.700(±5.560) μV vs. 4.820(±3.330) μV;  p  = 0.001].,['patients undergoing colonoscopy'],"['self-chosen music over earphones', 'endoscopic high-volume center']","['Clinician Satisfaction with Sedation Instrument (CSSI) and Patients Satisfaction with Sedation Instrument (PSSI', ""Patient's satisfaction"", 'Facial Electromyography (fEMG) activity', 'Clinician satisfaction', 'Overall satisfaction', 'stress level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0441067', 'cui_str': 'Earphones'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",,0.036297,Mean difference measured by fEMG via musculus zygomaticus major indicated a significantly lower stress level in the music group [7.700(±5.560) μV vs. 4.820(±3.330) μV;  p  = 0.001].,"[{'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Walter', 'Affiliation': 'Sektion Medizinische Psychologie, Klinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinik Ulm, Ulm, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Gruss', 'Affiliation': 'Sektion Medizinische Psychologie, Klinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinik Ulm, Ulm, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Neidlinger', 'Affiliation': 'Klinik für Innere Medizin I, Universitätsklinik Ulm, Ulm, Germany.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Stross', 'Affiliation': 'Klinik für Innere Medizin I, Universitätsklinik Ulm, Ulm, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hann', 'Affiliation': 'Medizinische Klinik und Polyklinik II, Universitätsklinik Würzburg, Würzburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wagner', 'Affiliation': 'Klinik für Innere Medizin I, Universitätsklinik Ulm, Ulm, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Seufferlein', 'Affiliation': 'Klinik für Innere Medizin I, Universitätsklinik Ulm, Ulm, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Walter', 'Affiliation': 'Klinik für Innere Medizin I, Universitätsklinik Ulm, Ulm, Germany.'}]",Frontiers in medicine,['10.3389/fmed.2020.00525']
2103,33043038,Evaluation of Maternal Dietary n-3 LCPUFA Supplementation as a Primary Strategy to Reduce Offspring Obesity: Lessons From the INFAT Trial and Implications for Future Research.,"Preclinical research suggests that early exposure to LCPUFAs is associated with offspring health outcomes, although evidence in humans is rather unclear. In 2006, we established the  Impact of Nutritional Fatty acids during pregnancy and lactation on early human Adipose Tissue development  (INFAT) study, a prospective randomized controlled intervention trial that examined whether decreasing the n-6/n-3 LCPUFA ratio during pregnancy and lactation influences offspring adipose tissue development in children up to 5 years. Our results indicate that maternal supplementation with n-3 LCPUFAs does not reduce offspring obesity risk, which is in line with recent publications. This perspective describes the challenges and lessons learned from our clinical trial. We discuss key findings and critically evaluate differences in study design, methodology, and analyses across similar intervention trials that may partly explain heterogeneous results. Summarizing evidence from human trials, we conclude that n-3 LCPUFA supplementation should not be recommended as a primordial strategy to prevent childhood obesity. Instead, it remains unknown whether n-3 LCPUFA supplementation could benefit high-risk subgroups and some vulnerable maternal/child populations. The perspectives offered herein are derived largely from insights gained from ours and similar n-3 LCPUFA intervention trials and help to provide direction for future research that examines the impact of maternal nutritional exposure on offspring health and disease outcomes.",2020,"Our results indicate that maternal supplementation with n-3 LCPUFAs does not reduce offspring obesity risk, which is in line with recent publications.",['children up to 5 years'],"['Nutritional Fatty acids', 'n-3 LCPUFA supplementation', 'n-3 LCPUFAs', 'Maternal Dietary n-3 LCPUFA Supplementation']",['n-6/n-3 LCPUFA ratio'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0589817,"Our results indicate that maternal supplementation with n-3 LCPUFAs does not reduce offspring obesity risk, which is in line with recent publications.","[{'ForeName': 'Dorothy Marie', 'Initials': 'DM', 'LastName': 'Meyer', 'Affiliation': 'Institute of Nutritional Medicine, School of Medicine, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Brei', 'Affiliation': 'Institute of Nutritional Medicine, School of Medicine, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Bernhard Lorenz', 'Initials': 'BL', 'LastName': 'Bader', 'Affiliation': 'ZIEL-Institute for Food and Health, Freising, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Hauner', 'Affiliation': 'Institute of Nutritional Medicine, School of Medicine, Technical University of Munich, Munich, Germany.'}]",Frontiers in nutrition,['10.3389/fnut.2020.00156']
2104,33043302,Implementation fidelity and acceptability of an intervention to improve vaccination uptake and child health in rural India: a mixed methods evaluation of a pilot cluster randomized controlled trial.,"Background


The Tika Vaani intervention, an initiative to improve basic health knowledge and empower beneficiaries to improve vaccination uptake and child health for underserved rural populations in India, was assessed in a pilot cluster randomized trial. The intervention was delivered through two strategies: mHealth (using mobile phones to send vaccination reminders and audio-based messages) and community mobilization (face-to-face meetings) in rural Indian villages from January to September 2018. We assessed acceptability and implementation fidelity to determine whether the intervention delivered in the pilot trial can be implemented at a larger scale.
Methods


We adapted the Conceptual Framework for implementation fidelity to assess acceptability and fidelity of the pilot interventions using a mixed methods design. Quantitative data sources include a structured checklist, household surveys, and mobile phone call patterns. Qualitative data came from field observations, intervention records, semi-structured interviews and focus groups with project recipients and implementers. Quantitative analyses assessed whether activities were implemented as planned, using descriptive statistics to describe participant characteristics and the percentage distribution of activities. Qualitative data were analyzed using content analysis and in the light of the implementation fidelity model to explore moderating factors and to determine how well the intervention was received.
Results


Findings demonstrated high (86.7%) implementation fidelity. A total of 94% of the target population benefited from the intervention by participating in a face-to-face group meeting or via mobile phone. The participants felt that the strategies were useful means for obtaining information. The clarity of the intervention theory, the motivation, and commitment of the implementers as well as the periodic meetings of the supervisors largely explain the high level of fidelity obtained. Geographic distance, access to a mobile phone, level of education, and gender norms are contextual factors that contributed to heterogeneity in participation.
Conclusions


Although the intervention was evaluated in the context of a randomized trial that could explain the high level of fidelity obtained, this evaluation provides confirmatory evidence that the results of the study reflect the underlying theory. The mobile platform coupled with community mobilization was well-received by the participants and could be a useful way to improve health knowledge and change behavior.
Trial registration


ISRCTN 44840759 (22 April 2018).",2020,"The mobile platform coupled with community mobilization was well-received by the participants and could be a useful way to improve health knowledge and change behavior.
","['rural India', 'rural Indian villages from January to September 2018']","['Tika Vaani intervention', 'mHealth (using mobile phones to send vaccination reminders and audio-based messages) and community mobilization (face-to-face meetings']","['health knowledge and change behavior', 'vaccination uptake and child health']","[{'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}]",,0.120731,"The mobile platform coupled with community mobilization was well-received by the participants and could be a useful way to improve health knowledge and change behavior.
","[{'ForeName': 'Myriam Cielo', 'Initials': 'MC', 'LastName': 'Pérez', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Tour Saint-Antoine, Porte S03-102, 850, rue St-Denis, Montréal, Québec H2X 0A9 Canada.""}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Chandra', 'Affiliation': 'Independent Consultant Tika Vaani, New Delhi, India.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Koné', 'Affiliation': 'Management Sciences for Health (MSH)/USAID, Port-au-Prince, Haiti.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Gram Vaani Community Media Pvt. Ltd., New Delhi, India.'}, {'ForeName': 'Valery', 'Initials': 'V', 'LastName': 'Ridde', 'Affiliation': 'Centre de recherche en santé publique, Université de Montréal, 7101 avenue du Parc, Montréal, Québec Canada.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Sylvestre', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Tour Saint-Antoine, Porte S03-102, 850, rue St-Denis, Montréal, Québec H2X 0A9 Canada.""}, {'ForeName': 'Aaditeshwar', 'Initials': 'A', 'LastName': 'Seth', 'Affiliation': 'Gram Vaani Community Media Pvt. Ltd., New Delhi, India.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Johri', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Tour Saint-Antoine, Porte S03-102, 850, rue St-Denis, Montréal, Québec H2X 0A9 Canada.""}]",Implementation science communications,['10.1186/s43058-020-00077-7']
2105,33043347,[Study on the efficacy and safety of metronidazole combined with periodontal tissue regeneration in the treatment of periodontitis].,"PURPOSE


To explore the efficacy and safety of ornidazole combined with periodontal tissue regeneration in the treatment of periodontitis.
METHODS


From March 2018 to March 2019, 100 patients with periodontitis who received treatment in the Stomatological Hospital Affiliated to the School of Medicine of Nanjing University were selected and randomly divided into the regeneration group and combined treatment group with 50 patients in each group. Patients in the regeneration group received periodontal tissue regeneration treatment, while patients in the combined treatment group received ornidazole combined periodontal tissue regeneration treatment. Related periodontal indexes including periodontal probing depth(PPD), periodontal attachment level(PAL), tooth mobility degree(MD) were measured, serum malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (gsh-px) and interleukin 10 (IL-10) and interleukin 4 (IL-4), c-reactive protein(CRP) level and immune globulin level were detected before and after treatment, the therapeutic effects and complications were recorded and compared. SPSS 21.0 software package was used for statistical analysis of the data.
RESULTS


After treatment, PPD, PAL and MD levels in the combined treatment groups were significantly lower than those in the regenerative group (P<0.05). Serum MDA level in the combined treatment group was significantly lower than that in the regenerative group, SOD and gsh-px levels were significantly higher than that in the regenerative group(P<0.05). The serum levels of IgA, IgM, IgG, IgE, IL-10, IL-4 and CRP in the combined treatment group were significantly lower than those in the regenerative treatment group (P<0.05). The total effective rate of the combined treatment group was significantly higher than that of the regenerative treatment group, and the incidence of complications was significantly lower than that of the regenerative group(P<0.05).
CONCLUSIONS


Ornidazole combined with periodontal tissue regeneration can improve the level of periodontal index, alleviate oxidative stress injury, improve immune function, inhibit inflammation, and has a significant therapeutic effect with high safety.",2020,"The serum levels of IgA, IgM, IgG, IgE, IL-10, IL-4 and CRP in the combined treatment group were significantly lower than those in the regenerative treatment group (P<0.05).","['periodontitis', 'From March 2018 to March 2019, 100 patients with periodontitis who received treatment in the Stomatological Hospital Affiliated to the School of Medicine of Nanjing University']","['metronidazole combined with periodontal tissue regeneration', 'periodontal tissue regeneration treatment', 'ornidazole combined with periodontal tissue regeneration', 'ornidazole combined periodontal tissue regeneration treatment']","['efficacy and safety', 'total effective rate', 'serum levels of IgA, IgM, IgG, IgE, IL-10, IL-4 and CRP', 'therapeutic effects and complications', 'Related periodontal indexes including periodontal probing depth(PPD), periodontal attachment level(PAL), tooth mobility degree(MD', 'SOD and gsh-px levels', 'incidence of complications', 'Serum MDA level', 'serum malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (gsh-px) and interleukin 10 (IL-10) and interleukin 4 (IL-4), c-reactive protein(CRP) level and immune globulin level', 'PPD, PAL and MD levels']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031104', 'cui_str': 'Structure of gum and supporting structure of tooth'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029274', 'cui_str': 'Ornidazole'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0031092', 'cui_str': 'Periodontal Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1882337', 'cui_str': 'Periodontal probe'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0040445', 'cui_str': 'Tooth mobility'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",100.0,0.0219561,"The serum levels of IgA, IgM, IgG, IgE, IL-10, IL-4 and CRP in the combined treatment group were significantly lower than those in the regenerative treatment group (P<0.05).","[{'ForeName': 'Meng-Jia', 'Initials': 'MJ', 'LastName': 'Wang', 'Affiliation': 'Department of Stomatology, Affiliated Stomatological Hospital, Medical College of Nanjing University. Nanjing 210018, China. E-mail:wangmengjia0088@sina.com.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'DA', 'Affiliation': ''}, {'ForeName': 'Li-Chun', 'Initials': 'LC', 'LastName': 'Zheng', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[]
2106,33043350,[Clinical evaluation of Er:YAG laser in the treatment of grade Ⅱ periodontitis with bifurcation lesions].,"PURPOSE


To evaluate the clinical efficacy of erbium-doped yttrium aluminium garnet (Er: YAG) laser in the treatment of degree II bifurcation periodontitis.
METHODS


Thirty patients(60 teeth) with grade II bifurcation lesions of chronic periodontitis were enrolled in this study. One week after supergingival scaling with ultrasound, the patients were randomly divided into experimental group: subgingival scaling with ultrasound and hand instruments + Er: YAG laser irradiation in periodontal pocket; control group: the contralateral homonymous teeth were treated with subgingival scaling with ultrasound and hand instruments alone. The changes of gingival index(GI), pocket depth(PD), horizontal probing depth (HPD) and attachment loss(AL) were compared between the two groups 12 and 20 weeks after treatment. SPSS 20.0 software package was used for statistical analysis.
RESULTS


Periodontal clinical indexes(GI, PD, HPD, AL) of the experimental group and control group were significantly reduced compared with baseline at 12 and 20 weeks after treatment(P<0.05). At 12 and 20 weeks after treatment, PD in the experimental group was (4.03±0.48) mm and (3.43±0.45) mm, (4.82±0.55) mm and (4.27±0.36) mm in the control group, respectively. The reduction of PD in the experimental group was significantly greater than that in the control group (P<0.05). There was no significant difference in HPD between the two groups at 12 weeks after treatment. Twenty weeks after operation, HPD in the experimental group was found to be (3.01±0.34) mm and (3.78±0.29) mm in the control group. The decrease of HPD in the experimental group was significantly greater than that in the control group (P<0.05). GI and AL of the experimental group at 12 and 20 weeks were lower than those of the control group, but the difference was not statistically significant.
CONCLUSIONS


Er: YAG laser is safe and effective in the treatment of chronic periodontitis patients with grade II root bifurcation lesions with significant clinical value.",2020,The reduction of PD in the experimental group was significantly greater than that in the control group (P<0.05).,"['degree II bifurcation periodontitis', 'chronic periodontitis patients with grade II root bifurcation lesions with significant clinical value', 'Thirty patients(60 teeth) with grade II bifurcation lesions of chronic periodontitis', 'grade Ⅱ periodontitis with bifurcation lesions']","['Er:YAG laser', 'Er: YAG laser', 'Er: YAG laser irradiation', 'subgingival scaling with ultrasound and hand instruments ', 'subgingival scaling with ultrasound and hand instruments alone', 'erbium-doped yttrium aluminium garnet (Er: YAG) laser']","['HPD', 'reduction of PD', 'GI and AL', 'changes of gingival index(GI), pocket depth(PD), horizontal probing depth (HPD) and attachment loss(AL', 'decrease of HPD']","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",30.0,0.0205988,The reduction of PD in the experimental group was significantly greater than that in the control group (P<0.05).,"[{'ForeName': 'Yu-Zhuo', 'Initials': 'YZ', 'LastName': 'Wu', 'Affiliation': 'Department of Periodontology, Nantong Stomatological Hospital. Nantong 226001, China. E-mail:huj19818@163.com.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'You-Min', 'Initials': 'YM', 'LastName': 'Mei', 'Affiliation': ''}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Huan', 'Affiliation': ''}, {'ForeName': 'Jing-Wei', 'Initials': 'JW', 'LastName': 'Sun', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[]
2107,33043351,[Clinical comparative study on aesthetic effect of all-ceramic micro-veneer and minimally invasive ultra-thin veneer in repairing deformed anterior teeth].,"PURPOSE


To compare the aesthetic effects of all-ceramic micro-veneer and minimally invasive ultra-thin veneer in repairing deformed anterior teeth.
METHODS


One hundred and twenty patients with deformed anterior teeth were selected for aesthetic restoration. According to the patient's personal condition, a suitable repair protocol was selected. Patients in the experimental group (60 cases) were repaired with all-ceramic micro-adhesive surface, while patients in the control group (60 cases) were treated with minimally invasive ultra-thin veneer. The US Public Health Administration's Evaluation Criteria (USPHS) scores were recorded and compared 6 months, 12 months, and 24 months after restoration. Statistical analysis was performed using SPSS 25.0 software package.
RESULTS


There was no significant difference in the integrity, color, marginal closeness, translucency and marginal staining of the restorations between the two groups 24 months after operation (P>0.05). The satisfaction rate of the aesthetics of the experimental group was significantly lower than that of the control group (71.60% vs 93.83%, P<0.05). The incidence of complications such as broken, detached and secondary caries during the follow-up period was significantly lower in the experimental group than in the control group (1.23% vs 11.11%, P<0.05).
CONCLUSIONS


The results showed that there is no significant difference in the success rate between the two methods. All-ceramic micro-veneer technique has good long-term effect, fewer complications, easy to collapse and stain the lip margin, but it has a small amount of teeth preparation and a low incidence of pulpitis in the later period. Minimally invasive super-thin veneer has high aesthetic value, so it is necessary to choose appropriate aesthetic repair methods according to the patients' needs.",2020,"The incidence of complications such as broken, detached and secondary caries during the follow-up period was significantly lower in the experimental group than in the control group (1.23% vs 11.11%, P<0.05).
",['One hundred and twenty patients with deformed anterior teeth were selected for aesthetic restoration'],"['minimally invasive ultra-thin veneer', 'ceramic micro-veneer and minimally invasive ultra-thin veneer']","['incidence of complications such as broken, detached and secondary caries', 'success rate', 'aesthetic effects', 'integrity, color, marginal closeness, translucency and marginal staining of the restorations', ""US Public Health Administration's Evaluation Criteria (USPHS) scores"", 'satisfaction rate of the aesthetics']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0559953', 'cui_str': 'Veneer'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1882989', 'cui_str': 'Secondary caries'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0034020', 'cui_str': 'Administration, Public Health'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",120.0,0.0207233,"The incidence of complications such as broken, detached and secondary caries during the follow-up period was significantly lower in the experimental group than in the control group (1.23% vs 11.11%, P<0.05).
","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Department of Prosthodontics, Urumqi Stomatological Hospital. Urumqi 830002, Xinjiang Uygur Autonomous Region, China. E-mail:119300761@qq.com.'}, {'ForeName': 'Mahesuti', 'Initials': 'M', 'LastName': 'Baihetiyaer', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Zhen-Hua', 'Initials': 'ZH', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Ze-Hui', 'Initials': 'ZH', 'LastName': 'Yang', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[]
2108,33043352,[Effect of autologous concentrated growth factor fibrin solution combined with Bio-Oss bone powder on mucosal healing and bone regeneration after oral implanted guided bone regeneration].,"PURPOSE


To investigate the effect of autologous concentrated growth factor fibrin solution combined with Bio-Oss bone powder on mucosal healing and bone regeneration after oral implanted guided bone regeneration.
METHODS


From October 2016 to December 2018, 83 patients with maxillary single anterior tooth loss and labial bone defect were treated, they were divided into two groups. Patients in the experimental group (42 cases) received autologous concentrated growth factor fibrin solution + Bio-Oss bone powder, while patients in the control group (41 cases) received Bio-Oss bone powder alone. The degree of mucosal healing, implant success, bone defect regeneration, pain and other complications were followed up 7 days, 6 weeks and 1 year after operation. The success rate and complications of the two groups were observed, as well as the differences of mucosal color, swelling degree, bleeding index, depth of probing, attachment loss, height of bone graft and thickness of bone formation were measured and recorded. Statistical analysis was performed using SPSS 25.0 software package.
RESULTS


There was no significant difference in the success rate of implants between the two groups (95.24% vs 97.56%, P>0.05). The complication rate of the experimental group was significantly lower than that of the control group (2.38% vs 14.63%, P<0.05). The mucosal color and swelling degree scores of the experimental group were significantly lower than those of the control group [(0.65±0.03) points vs (2.01±0.15) points, (1.10±0.37) points vs (2.69±0.54) points, P<0.05], and the bleeding index, probing depth, and attachment loss were significantly lower than the control group [(0.35±0.05) vs (0.49±0.09), (3.39±0.62) mm vs (4.41±0.95) mm, (3.02±0.66) mm vs (5.31±0.91) mm, P<0.05], bone graft height and osteogenesis height were significantly higher than the control group [(2.61±0.50) mm vs (2.20±0.31) mm, (2.53±0.34) mm vs (2.02±0.27) mm, P<0.05]. The degree of postoperative pain in the experimental group was significantly lower than that in the control group(P<0.05).
CONCLUSIONS


Rich self-concentrating growth factor fibrin solution combined with Bio-Oss bone powder can effectively promote mucosal healing and bone regeneration after oral implant-guided bone regeneration, and reduce postoperative pain and complications.",2020,"The success rate and complications of the two groups were observed, as well as the differences of mucosal color, swelling degree, bleeding index, depth of probing, attachment loss, height of bone graft and thickness of bone formation were measured and recorded.","['83 patients with maxillary single anterior tooth loss and labial bone defect', 'From October 2016 to December 2018']","['autologous concentrated growth factor fibrin solution + Bio-Oss bone powder', 'autologous concentrated growth factor fibrin solution combined with Bio-Oss bone powder', 'Bio-Oss bone powder alone']","['bone graft height and osteogenesis height', 'mucosal color and swelling degree scores', 'success rate and complications', 'degree of postoperative pain', 'mucosal color, swelling degree, bleeding index, depth of probing, attachment loss, height of bone graft and thickness of bone formation', 'postoperative pain and complications', 'bleeding index, probing depth, and', 'degree of mucosal healing, implant success, bone defect regeneration, pain and other complications', 'mucosal healing and bone regeneration', 'complication rate', 'attachment loss', 'success rate of implants']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0080233', 'cui_str': 'Tooth loss'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0174021', 'cui_str': 'Bio-Oss'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}]",83.0,0.0401376,"The success rate and complications of the two groups were observed, as well as the differences of mucosal color, swelling degree, bleeding index, depth of probing, attachment loss, height of bone graft and thickness of bone formation were measured and recorded.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Stomatology, Puyang Oilfield General Hospital. Puyang 457001, Henan Province, China. E-mail:bebetolin@163.com.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Mao', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Hou', 'Affiliation': ''}, {'ForeName': 'Xiao-Rong', 'Initials': 'XR', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'Jun-Hua', 'Initials': 'JH', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Xian-Yin', 'Initials': 'XY', 'LastName': 'Zhao', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[]
2109,33043353,[Investigation of the clinical effect of 65 μm glycine powder air-polishing(GPAP) after ultrasonic scaling during subgingival polishing].,"PURPOSE


To evaluate the clinical effect of 65 μm glycine powder air-polishing (GPAP) by comparing with sodium hydrogen carbonate after ultrasonic scaling during subgingival polishing.
METHODS


Thirty-three patients who were systematically healthy were involved in this study. After ultrasonic scaling,they were randomly assigned to the experimental group or the control group. Patients in the control group were treated with rubber cup + sodium hydrogen carbonate, while patients in the experimental group were treated only with 65 μm GPAP therapy. The clinical parameters including probing depth(PD), bleeding index(BI), plaque index(PI), staining index(SI) were recorded at baseline, 1week, 1 month, 3 months and 6 months after treatment. The results were analyzed by paired sample Wilcoxon signed-rank test with SPSS 23.0 software package.
RESULTS


Both methods had good clinical effects. PD, BI, PI and SI of the two groups at 1 month, 3 months and 6 months after treatment were significantly better than those at baseline (P<0.01). SI of the experimental groups was significantly lower than that of the control group at 1 month, 3 months and 6 months after treatment(P<0.01).
CONCLUSIONS


The results indicated that 65 μm GPAP may be as effective as sodium hydrogen carbonate after ultrasonic scaling in removal of dental plaque and stain. 65 μm GPAP had the advantage of reducing restaining.",2020,"SI of the experimental groups was significantly lower than that of the control group at 1 month, 3 months and 6 months after treatment(P<0.01).
",['Thirty-three patients who were systematically healthy were involved in this study'],"['sodium hydrogen carbonate', 'rubber cup + sodium hydrogen carbonate', '65 μm glycine powder air-polishing (GPAP', '65 μm GPAP therapy', '65 μm glycine powder air-polishing(GPAP']","['SI', 'probing depth(PD), bleeding index(BI), plaque index(PI), staining index(SI', 'advantage of reducing restaining', 'PD, BI, PI and SI']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}]",33.0,0.0150272,"SI of the experimental groups was significantly lower than that of the control group at 1 month, 3 months and 6 months after treatment(P<0.01).
","[{'ForeName': 'Zhao-Cheng', 'Initials': 'ZC', 'LastName': 'Shi', 'Affiliation': 'Shanghai Stomatological Hospital. Shanghai 200031, China. E-mail:601760972@qq.com.'}, {'ForeName': 'Li-Ming', 'Initials': 'LM', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Zhi-Feng', 'Initials': 'ZF', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Sheng-Yao', 'Initials': 'SY', 'LastName': 'Ao', 'Affiliation': ''}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[]
2110,33043381,Elastic bands training after triamcinolone acetonide injection in subacromial bursitis: A randomized clinical trial.,"OBJECTIVE


To investigate the effect of progressive resistance training using resistance (elastic) bands on subacromial bursitis following triamcinolone acetonide injection.
DESIGN


Randomized clinical trial.
PATIENTS


A total of 68 patients with subacromial bursitis were randomized to a triamcinolone acetonide group or a triamcinolone acetonide plus resistance band training group.
METHODS


Visual analogue scale (VAS), Constant scores, range of motion (ROM), proprioception, and muscle strength were evaluated at pretreatment and at 3, 12 and 24 weeks' follow-up. Re-treatment ratio was calculated at 1-year follow-up.
RESULTS


At 3 and 12 weeks, both the triamcinolone acetonide group and triamcinolone acetonide plus resistance band training group showed a significant improvement in VAS score, Constant score, ROM, proprioception and muscle strength. Although the scores in the triamcinolone acetonide group had not increased at 24 weeks compared with baseline, the scores in the triamcinolone acetonide plus resistance band training group showed continued improvement at 24 weeks. A lower proportion of patients in the triamcinolone acetonide plus resistance band training bands group than in the triamcinolone acetonide group had received re-treatment at 1-year follow-up (12.1% vs 82.9%).
CONCLUSION


Progressive resistance training with resistance (elastic) bands has the advantages of extending the benefits of corticosteroid injection and maintaining long-term effects on shoulder function in patients with subacromial bursitis.",2020,"Although the scores in the triamcinolone acetonide group had not increased at 24 weeks compared with baseline, the scores in the triamcinolone acetonide plus resistance band training group showed continued improvement at 24 weeks.","['subacromial bursitis', '68 patients with subacromial bursitis', 'patients with subacromial bursitis']","['triamcinolone acetonide injection', 'triamcinolone acetonide plus resistance band training', 'Elastic bands training', 'progressive resistance training', 'triamcinolone acetonide plus resistance band training group', 'triamcinolone acetonide']","['VAS score, Constant score, ROM, proprioception and muscle strength', 'Visual analogue scale (VAS), Constant scores, range of motion (ROM), proprioception, and muscle strength']","[{'cui': 'C0546953', 'cui_str': 'Subacromial bursitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",68.0,0.0713415,"Although the scores in the triamcinolone acetonide group had not increased at 24 weeks compared with baseline, the scores in the triamcinolone acetonide plus resistance band training group showed continued improvement at 24 weeks.","[{'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiology, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Bokai', 'Initials': 'B', 'LastName': 'Liao', 'Affiliation': ''}, {'ForeName': 'Zhengchao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Zhenxing', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2752']
2111,33043411,A Mixed Methods Study on Engagement and Satisfaction with a Digitally-Enhanced Pilot Intervention Among African American and Hispanic Women.,"African American and Hispanic women report less physical activity (PA) than non-Hispanic White women. As such, a digitally-enhanced 16-week social support pilot intervention was conducted to promote PA among African American and Hispanic women dyads. This study quantitatively and qualitatively examined the engagement and satisfaction of participants (N = 30; 15 dyads) assigned to the intervention. Intervention participants received telephone counseling calls based on motivational interviewing and a Jawbone UP activity monitor. Intervention engagement and satisfaction data were collected from the Jawbone UP, call logs, self-report questionnaires conducted at the 16-week follow-up, and two post-intervention focus groups. Nonparametric tests assessed group differences across engagement and satisfaction measures, and a manually-driven coding scheme was used to evaluate emerging themes from qualitative text. Participants demonstrated high engagement in the telephone counseling sessions and moderate engagement with the Jawbone UP. Friend/co-worker dyads and participants who were 45 years and older were more likely to use the device. Qualitative results emphasized participants' appreciation for the counseling calls, the Jawbone UP, and the overall dyadic framework of the study to collectively nurture social support and accountability for PA. Overall, the intervention group reacted positively to study components. Additional research is needed to understand the role of technology in facilitating long-lasting PA change via social support in minority populations.",2020,"Qualitative results emphasized participants' appreciation for the counseling calls, the Jawbone UP, and the overall dyadic framework of the study to collectively nurture social support and accountability for PA.","['African American and Hispanic women', 'non-Hispanic White women', 'African American and Hispanic women dyads', 'African American and Hispanic Women']","['telephone counseling calls based on motivational interviewing and a Jawbone UP activity monitor', 'Digitally-Enhanced Pilot Intervention']",['physical activity (PA'],"[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.015951,"Qualitative results emphasized participants' appreciation for the counseling calls, the Jawbone UP, and the overall dyadic framework of the study to collectively nurture social support and accountability for PA.","[{'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'John', 'Affiliation': 'The University of Texas Health Science Center, Houston, TX, 77030, USA. jemima.john@uth.tmc.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.'}, {'ForeName': 'L H M', 'Initials': 'LHM', 'LastName': 'McNeill', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Basen-Engquist', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Hoover', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Daniel', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.'}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Strong', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.'}]",Journal of immigrant and minority health,['10.1007/s10903-020-01095-2']
2112,33043475,Digital technology for anaphylaxis management impact on patient behaviour. A randomised clinical Trial.,"BACKGROUND


Epinephrine is the first-line treatment for anaphylaxis. Patients at risk should always carry an epinephrine auto-injector (EAI). Several EAI gaps have been identified. We sought to evaluate satisfaction using a medical device (digital technology comprising an EAI smart case connected to a mobile APP) with functions that overcome most of the EAI limitations and to determine whether patient behaviour and anaphylaxis management improve with its use.
METHODS


This was a randomised, open-label, crossover clinical trial in a tertiary hospital involving patients with history of anaphylaxis carrying an EAI. The study was conducted in two three-month periods, one with and one without the medical device. The primary endpoint was satisfaction with the medical device. Usability, adherence, anxiety and anaphylaxis episodes were evaluated as secondary endpoints.
RESULTS


A total of 100 patients were included (mean age 38.1 years, 74% female) and 95 completed the trial. The satisfaction Visual Analogue Scale (VAS) after using the medical device was higher than before its use (89.1 [95% CI, 60.2-99.1] vs 56.3 [95% CI, 48.1-81.4]; p<0.0001). The adherence VAS improved from 59.7 (95% CI, 54.0-65.3) to 88.6 (95% CI, 84.2-92.9) (p<0.0001). Overall, 90% patients found the medical device easy to use. Patients' anxiety decreased from 52.2% to 29.3% (p<0.001). Seven episodes of anaphylaxis occurred during the study, all in patients without the medical device (p=0.025). Eighty-eight per cent of patients felt more involved in the management of anaphylaxis when using the medical device.
CONCLUSION


This is the first clinical trial evaluating digital technology for EAIs, showing a change of behaviour in patients at risk of anaphylaxis, increasing satisfaction, improving adherence, reducing anxiety, with good usability.",2020,"Seven episodes of anaphylaxis occurred during the study, all in patients without the medical device (p=0.025).","['patients with history of anaphylaxis carrying an EAI', 'patient behaviour', 'A total of 100 patients were included (mean age 38.1 years, 74% female) and 95 completed the trial']","['epinephrine auto-injector (EAI', 'Epinephrine']","['satisfaction with the medical device', ""Patients' anxiety"", 'satisfaction Visual Analogue Scale (VAS', 'anaphylaxis', 'adherence VAS', 'Usability, adherence, anxiety and anaphylaxis episodes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C4047001', 'cui_str': 'Epinephrine Auto-Injector [Epipen]'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4047001', 'cui_str': 'Epinephrine Auto-Injector [Epipen]'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",100.0,0.119462,"Seven episodes of anaphylaxis occurred during the study, all in patients without the medical device (p=0.025).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sala-Cunill', 'Affiliation': ""Allergy Section, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Luengo', 'Affiliation': ""Allergy Section, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Curran', 'Affiliation': ""Vall d'Hebron Research Institute, Barcelona, Spain.""}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Moreno', 'Affiliation': ""Allergy Section, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Moises', 'Initials': 'M', 'LastName': 'Labrador-Horrillo', 'Affiliation': ""Allergy Section, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Guilarte', 'Affiliation': ""Allergy Section, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Gonzalez-Medina', 'Affiliation': ""Allergy Section, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Galvan-Blasco', 'Affiliation': ""Allergy Section, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Cardona', 'Initials': 'C', 'LastName': 'Victoria', 'Affiliation': ""Allergy Section, Vall d'Hebron University Hospital, Barcelona, Spain.""}]",Allergy,['10.1111/all.14626']
2113,33043552,The impact of regular bisoprolol on the response to salbutamol in asthma: A double-blind randomized placebo-controlled crossover trial.,"BACKGROUND AND OBJECTIVE


Non-selective beta-blockers impair the bronchodilator response to beta 2  -agonists. Cardio-selective beta 1  -blockers are less likely to cause this effect, yet they remain relatively contraindicated in asthma. We investigated whether the response to salbutamol is impaired during cardio-selective beta 1  -blocker treatment in people with asthma.
METHODS


A random-order, double-blind, placebo-controlled, non-inferiority, crossover study was conducted comparing up to 5 mg bisoprolol daily for 2 weeks with matching placebo, with an open-label extension of up to 10 mg bisoprolol daily. After each treatment period, mannitol was inhaled to induce bronchoconstriction with a 15% fall in forced expiratory volume in 1 s (FEV 1  ). Immediately after mannitol challenge, salbutamol (100, 100 and 200 μg) was administered via spacer at 5-min intervals with repeated FEV 1  measures. The FEV 1  recovery with salbutamol was measured as an area under recovery curve (AUC). Based on earlier research, a clinically relevant non-inferiority limit of a 30% reduction in the AUC was set.
RESULTS


A total of 19 adults with mild asthma and positive inhaled mannitol challenge completed the study. Adjusting for the FEV 1  fall induced by mannitol and treatment sequence, the mean AUC response to salbutamol after bisoprolol was 5% lower than after placebo, with a one-sided 95% confidence interval (CI) of 26% lower. Thirteen participants completed the open-label extension up to 10 mg bisoprolol daily with mean AUC 11% higher after bisoprolol with a 95% CI of 5% lower.
CONCLUSION


The bronchodilator response to rescue salbutamol after mannitol-induced bronchoconstriction is non-inferior during regular treatment with the cardio-selective beta 1  -blocker, bisoprolol, compared to placebo.
CLINICAL TRIAL REGISTRATION


ACTRN12618000306213 at https://www.anzctr.org.au.",2020,"The bronchodilator response to rescue salbutamol after mannitol-induced bronchoconstriction is non-inferior during regular treatment with the cardio-selective beta 1  -blocker, bisoprolol, compared to placebo.
","['asthma', 'people with asthma', '19 adults with mild asthma and positive inhaled mannitol challenge completed the study']","['mannitol', 'placebo', 'salbutamol', 'regular bisoprolol']",['mean AUC response'],"[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",19.0,0.588273,"The bronchodilator response to rescue salbutamol after mannitol-induced bronchoconstriction is non-inferior during regular treatment with the cardio-selective beta 1  -blocker, bisoprolol, compared to placebo.
","[{'ForeName': 'Miriam R', 'Initials': 'MR', 'LastName': 'Bennett', 'Affiliation': 'Respiratory Research Unit, Department of Respiratory Medicine, Waikato Hospital, Hamilton, New Zealand.'}, {'ForeName': 'Catherina L', 'Initials': 'CL', 'LastName': 'Chang', 'Affiliation': 'Respiratory Research Unit, Department of Respiratory Medicine, Waikato Hospital, Hamilton, New Zealand.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Tuffery', 'Affiliation': 'Respiratory Research Unit, Department of Respiratory Medicine, Waikato Hospital, Hamilton, New Zealand.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Hopping', 'Affiliation': 'Respiratory Research Unit, Department of Respiratory Medicine, Waikato Hospital, Hamilton, New Zealand.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hancox', 'Affiliation': 'Respiratory Research Unit, Department of Respiratory Medicine, Waikato Hospital, Hamilton, New Zealand.'}]","Respirology (Carlton, Vic.)",['10.1111/resp.13955']
2114,33043591,Efficacy and safety of Exenatide as add-on therapy for type 2 diabetes patients with intensive insulin regimen: a randomized double-blind trial.,"AIMS


A significant percentage of type 2 diabetes (T2D) patients remain uncontrolled despite treatment using intensified insulin regimens (IIR), leading diabetes physicians to consider further intensification. We assessed the safety and efficacy of the short-acting GLP-1RA exenatide on a population of T2D patients mostly treated with continuous subcutaneous insulin injection (CSII).
MATERIALS AND METHODS


Phase 2/3, multicenter, randomized, parallel groups, double blind, placebo-controlled 6-month trial. Patients were randomized to receive subcutaneous (SC) injections of exenatide (10μg BID) or matched-placebo.
RESULTS


A total of 46 patients with T2D and elevated HbA1c were randomized (42% of the planned sample size): exenatide (n=28) and placebo (n=18). CSII treatment was used by 75% and 89% patients of exenatide and placebo groups, respectively. At 6 months: ΔHbA1c was -0.62±0.94 and 0.08±0.81% in exenatide and placebo groups, respectively (difference, -0.70; 95%Confidence Interval [-1.24 ; -0.15], p=0.014); body weight and BMI decreased in the exenatide group (-2.55±3.25 kg and -1.00±1.31 kg/m 2  ) and increased in the placebo group (1.29±2.82 kg and 0.46±1.16 kg/m 2  ) (observed difference, -3.85 and -1.45 respectively, both p<0.001); the post-dinner capillary blood glucose value was lower in the exenatide group compared to the placebo group (162.4±80.5 vs 259.1±94.4 mg/dL, respectively; observed difference, -96.7, p<0.01). Hypoglycemic risk, quality of life and overall safety were not different between groups, apart from the expected occurrence of digestive effects in the exenatide group.
CONCLUSIONS


Although we failed to reach our planned sample size, the addition of exenatide treatment 10μg BID SC in T2D patients with uncontrolled HbA1c despite an IIR, resulted in a significant reduction of HbA1c and body weight with a good overall safety profile and acceptance. This article is protected by copyright. All rights reserved.",2020,"Hypoglycemic risk, quality of life and overall safety were not different between groups, apart from the expected occurrence of digestive effects in the exenatide group.
","['T2D patients mostly treated with continuous subcutaneous insulin injection (CSII', 'type 2 diabetes patients with intensive insulin regimen', '46 patients with T2D and elevated HbA1c']","['short-acting GLP-1RA exenatide', 'exenatide', 'Exenatide', 'subcutaneous (SC) injections of exenatide (10μg BID) or matched-placebo', 'exenatide and placebo', 'placebo']","['safety and efficacy', 'post-dinner capillary blood glucose value', 'body weight and BMI', 'HbA1c and body weight', 'Efficacy and safety', 'Hypoglycemic risk, quality of life and overall safety', 'digestive effects']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",46.0,0.620012,"Hypoglycemic risk, quality of life and overall safety were not different between groups, apart from the expected occurrence of digestive effects in the exenatide group.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joubert', 'Affiliation': 'Diabetes Care Unit - Caen University Hospital, France.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Opigez', 'Affiliation': 'Diabetes Care Unit - Caen University Hospital, France.'}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Pavlikova', 'Affiliation': '1st. Department of Internal Medicine, Charles University Hospital in Pilsen, Czech Republic.'}, {'ForeName': 'Laure Peyro Saint', 'Initials': 'LPS', 'LastName': 'Paul', 'Affiliation': 'Clinical Research Unit - Caen University Hospital -, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Jeandidier', 'Affiliation': 'Diabetes Care Unit - Strasbourg University Hospital -, France.'}, {'ForeName': 'Anaïs R', 'Initials': 'AR', 'LastName': 'Briant', 'Affiliation': 'Clinical Research Unit - Caen University Hospital -, France.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Parienti', 'Affiliation': 'Unicaen, Caen, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Reznik', 'Affiliation': 'Diabetes Care Unit - Caen University Hospital, France.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14225']
2115,33043600,"Efficacy and Safety of Guselkumab, an Interleukin-23p19-Specific Monoclonal Antibody, Through 1 Year in Biologic-naïve Psoriatic Arthritis Patients.","OBJECTIVE


Guselkumab, a human monoclonal antibody specific to interleukin-23p19, demonstrated efficacy and safety versus placebo through Week24 of the Phase-3 DISCOVER-2 trial in biologic-naïve psoriatic arthritis (PsA) patients. Here we report 1-year DISCOVER-2 findings.
METHODS


Adults with active PsA (≥5 swollen+≥5 tender joints; C-reactive protein ≥0.6mg/dL) despite standard nonbiologic treatment were randomized to receive subcutaneous injections of guselkumab 100mg every-4-weeks (Q4W); guselkumab 100mg at Week0, Week4, Q8W; or placebo with crossover to guselkumab 100mg Q4W at Week24. We primarily evaluated clinical efficacy through Week52 by imputing missing data (nonresponse for categorical endpoints; no change/using multiple imputation for continuous endpoints). Observed radiographic scores and adverse events (AEs) were summarized.
RESULTS


Of 739 randomized, treated patients, 93% completed Week52. Proportions of patients achieving ≥20% improvement from baseline in ACR criteria (ACR20) were maintained post-Week24, reaching 71% (173/245) and 75% (185/248) for Q4W- and Q8W- randomized patients, respectively, by Week52. The proportions of patients achieving ACR50/ACR70 and skin responses, minimal or very low disease activity, and dactylitis or enthesitis resolution were also maintained through Week52. Further, low levels of radiographic progression, along with improvements in physical function and health-related quality-of-life, were sustained through Week52 with continued guselkumab. Few patients experienced serious infections through Week52, with no evidence of a dosing regimen response or increase from Week0-24 (4/493 [0.8%]) to Week24-52 (3/493 [0.6%]) among guselkumab-randomized patients. No patient developed an opportunistic infection or died.
CONCLUSION


In biologic-naïve PsA patients, guselkumab provided sustained improvements across diverse manifestations and maintained a favorable benefit-risk profile through Week52.",2020,"OBJECTIVE


Guselkumab, a human monoclonal antibody specific to interleukin-23p19, demonstrated efficacy and safety versus placebo through Week24 of the Phase-3 DISCOVER-2 trial in biologic-naïve psoriatic arthritis (PsA) patients.","['Adults with active PsA (≥5 swollen+≥5 tender joints; C-reactive protein ≥0.6mg/dL) despite standard nonbiologic treatment', 'Biologic-naïve Psoriatic Arthritis Patients', 'biologic-naïve psoriatic arthritis (PsA) patients']","['placebo', 'Guselkumab', 'subcutaneous injections of guselkumab 100mg every-4-weeks (Q4W); guselkumab 100mg at Week0, Week4, Q8W; or placebo with crossover to guselkumab 100mg Q4W at Week24']","['radiographic scores and adverse events (AEs', 'ACR50/ACR70 and skin responses, minimal or very low disease activity, and dactylitis or enthesitis resolution', 'ACR criteria (ACR20', 'physical function and health-related quality-of-life', 'opportunistic infection or died']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0240094', 'cui_str': 'Tenderness of joint'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0312646', 'cui_str': 'Finding related to response to skin test'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis'}, {'cui': 'C1282952', 'cui_str': 'Enthesitis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.236911,"OBJECTIVE


Guselkumab, a human monoclonal antibody specific to interleukin-23p19, demonstrated efficacy and safety versus placebo through Week24 of the Phase-3 DISCOVER-2 trial in biologic-naïve psoriatic arthritis (PsA) patients.","[{'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'Immunology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Proton', 'Initials': 'P', 'LastName': 'Rahman', 'Affiliation': 'Rheumatology, Memorial University of Newfoundland, St. Johns, NL, Canada.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Immunology, Janssen Research and Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Alexa P', 'Initials': 'AP', 'LastName': 'Kollmeier', 'Affiliation': 'Immunology, Janssen Research and Development, LLC, La Jolla, CA, USA.'}, {'ForeName': 'Soumya D', 'Initials': 'SD', 'LastName': 'Chakravarty', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham and Drexel University College of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Xie L', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': 'Immunology, Janssen Research and Development, LLC, San Diego, CA, USA.'}, {'ForeName': 'Ramanand A', 'Initials': 'RA', 'LastName': 'Subramanian', 'Affiliation': 'Immunology, Janssen Research and Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Prasheen', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': 'Clinical Biostatistics, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Shihong', 'Initials': 'S', 'LastName': 'Sheng', 'Affiliation': 'Clinical Biostatistics, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Yusang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Clinical Biostatistics, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Clinical Biostatistics, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Zhuang', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'der Heijde', 'Affiliation': 'Rheumatology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Rheumatology, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41553']
2116,33043638,"Helping Couples Connect during the COVID-19 Pandemic: A Pilot Randomised Controlled Trial of an Awareness, Courage, and Love Intervention.","BACKGROUND


A second pandemic of mental health problems due to COVID-19 is predicted, suggesting a demand for interventions to mitigate its impacts. This study evaluated the effectiveness of an online psychological intervention based on the Awareness, Courage, and Love (ACL) model from Functional Analytic Psychotherapy to promote closeness between couples during the pandemic.
METHOD


Thirty-one couples were randomised into either the intervention or control group for a 2-hour online group session. The intervention was designed to increase closeness between couples, whereas control group members watched a movie. In both groups, participants responded to two instruments that assessed the couple's relationship. Generalised linear mixed modeling was used to compare the change scores over time between the groups, with random effects used to control for the correlation within a couple and the correlation within the individual.
RESULTS


The intervention group's closeness increased by 23 per cent while the control group's closeness increased only 2 per cent. A week later, a significant difference between the two groups emerged on closeness.
CONCLUSION


Online ACL protocols requiring minimal training offer a promising intervention to quickly buffer against stress for large numbers of individuals during pandemic times.",2020,The intervention group's closeness increased by 23 per cent while the control group's closeness increased only 2 per cent.,['Thirty-one couples'],"['control group members watched a movie', 'online psychological intervention based on the Awareness, Courage, and Love (ACL) model from Functional Analytic Psychotherapy']",[],"[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0870365', 'cui_str': 'Bravery'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]",[],31.0,0.0271658,The intervention group's closeness increased by 23 per cent while the control group's closeness increased only 2 per cent.,"[{'ForeName': 'Mavis', 'Initials': 'M', 'LastName': 'Tsai', 'Affiliation': 'University of Washington, USA.'}, {'ForeName': 'Emerson', 'Initials': 'E', 'LastName': 'Hardebeck', 'Affiliation': 'University of Washington, USA.'}, {'ForeName': 'Fabiana Pinheiro', 'Initials': 'FP', 'LastName': 'Ramos', 'Affiliation': 'Federal University of Espirito Santo, Brazil.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Turlove', 'Affiliation': 'University of Washington, USA.'}, {'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Nordal-Jonsson', 'Affiliation': 'University of Washington, USA.'}, {'ForeName': 'Akoly', 'Initials': 'A', 'LastName': 'Vongdala', 'Affiliation': 'University of Washington, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""China Women's University, China.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Kohlenberg', 'Affiliation': 'University of Washington, USA.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12241']
2117,33043659,Mitral valve surgery combined with on-pump versus off-pump myocardial revascularization: A prospective randomized analysis with midterm follow-up.,"BACKGROUND


The aim of the study was to compare results off-pump coronary artery bypass (OPCAB) combined mitral valve reconstruction (MVR) with standard on-pump approach.
METHODS


From January 2014 to December 2017, a total of 53 patients received a combined myocardial revascularization and MVR for multivessel coronary artery disease (CAD) complicated by severe ischemic mitral regurgitation (IMR). All the subjects were divided into two groups: group I: 27 patients, received OPCAB + MVR, and group II (control group): 26 patients with on-pump myocardial revascularization (ONCAB) + MVR.
RESULTS


The aortic cross-clamp (ACC) and cardio-pulmonary bypass (CPB) times were longer in group II, 47.0 (44.0; 55.0) vs 94.5 (89.75; 105.5) minutes, P < .05 and 70.0 (63.0; 77.0) vs 138.5 (127.0; 157.5) minutes, P < .05, respectively. Evaluation of major clinical events showed that the implementation of the off-pump stage of myocardial revascularization in patients with severe IMR did not lead to significant changes in the mortality and postoperative complications. Furthermore, its use did not affect the volume of blood loss and need for blood transfusion, the duration of mechanical ventilation, the need for inotropic therapy, as well as the duration of the patient's resuscitation and the total duration of hospitalization, with the one exception: the troponin-T level increase in the OPCAB + MVR group was less than in the ONCAB + MVR group.
CONCLUSION


OPCAB combined MVR in patients with CAD and severe IMR can be performed with shorter CPB and ACC times, and lower troponin-T level after surgery, without reducing the risk of surgical complications.",2020,"The aortic cross-clamp (ACC) and cardio-pulmonary bypass (CPB) times were longer in group II, 47.0 (44.0; 55.0) vs 94.5 (89.75; 105.5) minutes, P < .05 and 70.0 (63.0; 77.0) vs 138.5 (127.0; 157.5) minutes, P < .05, respectively.","['patients with severe IMR', 'patients with CAD and severe IMR', 'for multivessel coronary artery disease (CAD) complicated by severe ischemic mitral regurgitation (IMR', 'From January 2014 to December 2017, a total of 53 patients received a']","['OPCAB\u2009+\u2009MVR, and group II (control group): 26 patients with on-pump myocardial revascularization (ONCAB)\u2009+\u2009MVR', 'pump coronary artery bypass (OPCAB) combined mitral valve reconstruction (MVR', 'combined myocardial revascularization and MVR', 'Mitral valve surgery combined with on-pump versus off-pump myocardial revascularization']","['troponin-T level', 'aortic cross-clamp (ACC) and cardio-pulmonary bypass (CPB) times', 'total duration of hospitalization', 'troponin-T level increase', 'volume of blood loss and need for blood transfusion, the duration of mechanical ventilation', 'risk of surgical complications', 'mortality and postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4087284', 'cui_str': 'Ischaemic mitral regurgitation'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0027056', 'cui_str': 'Myocardial revascularization'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",26.0,0.0281927,"The aortic cross-clamp (ACC) and cardio-pulmonary bypass (CPB) times were longer in group II, 47.0 (44.0; 55.0) vs 94.5 (89.75; 105.5) minutes, P < .05 and 70.0 (63.0; 77.0) vs 138.5 (127.0; 157.5) minutes, P < .05, respectively.","[{'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Zavolozhin', 'Affiliation': 'Department of Surgery, Arkhangelsk State Medical University, Arkhangelsk, Russia.'}, {'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Shonbin', 'Affiliation': 'Department of Surgery, Arkhangelsk State Medical University, Arkhangelsk, Russia.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Bystrov', 'Affiliation': 'Department of Cardiac Surgery, City Hospital No 1, Arkhangelsk, Russia.'}, {'ForeName': 'Soslan', 'Initials': 'S', 'LastName': 'Enginoev', 'Affiliation': 'Department of Cardiac Surgery, FSBI Federal Centre for Cardiovascular Surgery of the Ministry of Health of the Russian Federation, Astrakhan, Russia.'}]",Journal of cardiac surgery,['10.1111/jocs.14861']
2118,33043684,Mixed methods pilot evaluation of interpersonal psychotherapy for body image for adolescents.,"Body dissatisfaction is common in adolescence and associated with poor outcomes. The aim of this mixed method pilot evaluation was to determine acceptability, feasibility and preliminary efficacy of Interpersonal Psychotherapy for Body Image (IPT-BI), a school-based group intervention for young people with high levels of body dissatisfaction. Eighteen participants (11-13 years, 78% female) took part in two IPT-BI groups ( n  = 10;  n  = 8). Feasibility was measured by recruitment and attrition rates; acceptability using a treatment satisfaction questionnaire and focus groups; and clinical outcomes at baseline, each session and post intervention. The majority of young people (72%,  n  = 18/25) who were referred or expressed interest went on to take part. Average session attendance was 100% and 89%. Participants expressed high levels of treatment satisfaction with 94% ( n  = 16/17) rating IPT-BI as 'quite helpful' or 'very helpful' and 94% ( n  = 16/17) stating they would recommend it to others. Preliminary exploration of efficacy showed significant improvements in body image and significant reductions in interpersonal difficulties and appearance-based conversations. Young people valued specific IPT-BI skills (role play, communication strategies), alongside generic therapeutic factors (therapeutic alliance, group cohesion). IPT-BI is feasible and acceptable with promising provisional clinical outcomes indicating the need for a fully powered randomised controlled trial.",2020,"The majority of young people (72%,  n  = 18/25) who were referred or expressed interest went on to take part.","['young people with high levels of body dissatisfaction', 'adolescents', 'Eighteen participants (11-13\u2009years, 78% female) took part in two IPT-BI groups ( n \u2009=\u200910;  n \u2009=\u20098', 'young people (72%,  n \u2009=\u200918/25) who were referred or expressed interest went on to take part']","['Interpersonal Psychotherapy for Body Image', 'IPT-BI', 'school-based group intervention', 'interpersonal psychotherapy']","['high levels of treatment satisfaction', 'recruitment and attrition rates; acceptability', 'interpersonal difficulties and appearance-based conversations', 'Average session attendance']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]","[{'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",,0.0564013,"The majority of young people (72%,  n  = 18/25) who were referred or expressed interest went on to take part.","[{'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Duffy', 'Affiliation': 'Department of Clinical Psychology, School of Health in Social Science, University of Edinburgh, Medical School, Edinburgh, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Sharpe', 'Affiliation': 'Department of Clinical Psychology, School of Health in Social Science, University of Edinburgh, Medical School, Edinburgh, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Beveridge', 'Affiliation': 'Department of Clinical Psychology, School of Health in Social Science, University of Edinburgh, Medical School, Edinburgh, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Osborne', 'Affiliation': 'Department of Clinical Psychology, School of Health in Social Science, University of Edinburgh, Medical School, Edinburgh, UK.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Richards', 'Affiliation': 'Department of Clinical Psychology, School of Health in Social Science, University of Edinburgh, Medical School, Edinburgh, UK.'}]",Clinical child psychology and psychiatry,['10.1177/1359104520963371']
2119,33043691,"Clonidine as an Adjuvant to Bupivacaine for Suprazygomatic Maxillary Nerve Blocks in Cleft lip and Palate Repair: A Randomized, Prospective, Double-Blind Study.","OBJECTIVES


Does clonidine, as adjuvant to bupivacaine for suprazygomatic maxillary nerve blocks, reduce emergence agitation in patients undergoing cleft lip and cleft palate surgery?
DESIGN


Randomized, controlled, and double-blind study.
SETTING


Guwahati Comprehensive Cleft Care Center, Guwahati (Assam, India).
PARTICIPANTS


A total of 124 patients; with a median age of 5 years in the clonidine group (CLG) and 7 years in the control group (CG), who underwent cleft lip or cleft palate surgery were included. Exclusion criteria included lack of consent from patients or their guardians, allergy to local anesthetics, coagulation disorders, local infection at the puncture site before performing the block, and language difficulties or cognitive disorders.
INTERVENTIONS


Patients were randomized into 2 groups to receive bilateral suprazygomatic maxillary nerve blocks with either a bupivacaine/clonidine mixture for the CLG or bupivacaine alone in the CG.
MAIN OUTCOME MEASURE


The primary end point was the incidence of emergence agitation.
RESULTS


There was a statistically significant difference in the incidence of emergence agitation (30.2% in the CG compared to 15.2% in the CLG; difference of incidences: 15%, 95% CI: 0.1-30.1). The percentage of patients requiring intraoperative Fentanyl was lower in the CLG (10.6% compared to 26.4%; difference of incidences: 15.8%, 95% CI: 1.8-29). No other differences were observed. Further research in a more typically aged children population undergoing cleft surgery is needed.
CONCLUSIONS


The use of clonidine as an adjuvant to bupivacaine in maxillary nerve block reduces the incidence of emergence agitation and intraoperative opioid consumption without hemodynamic or sedative side effects in patients undergoing cleft lip and palate surgery.",2020,"There was a statistically significant difference in the incidence of emergence agitation (30.2% in the CG compared to 15.2% in the CLG; difference of incidences: 15%, 95% CI: 0.1-30.1).","['aged children population undergoing cleft surgery', 'Cleft lip and Palate Repair', 'Exclusion criteria included lack of consent from patients or their guardians, allergy to local anesthetics, coagulation disorders, local infection at the puncture site before performing the block, and language difficulties or cognitive disorders', 'patients undergoing cleft lip and palate surgery', 'patients undergoing cleft lip and cleft palate surgery', 'Guwahati Comprehensive Cleft Care Center, Guwahati (Assam, India', 'A total of 124 patients; with a median age of 5 years in the clonidine group (CLG) and 7 years in the control group (CG), who underwent cleft lip or cleft palate surgery were included']","['bupivacaine', 'Bupivacaine', 'Clonidine', 'bilateral suprazygomatic maxillary nerve blocks with either a bupivacaine/clonidine mixture for the CLG or bupivacaine', 'clonidine']","['incidence of emergence agitation', 'percentage of patients requiring intraoperative Fentanyl']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205242', 'cui_str': 'Cleaved'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0158646', 'cui_str': 'Cleft palate with cleft lip'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0570642', 'cui_str': 'Allergy to local anesthetic'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0564213', 'cui_str': 'Difficulty using language'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0008924', 'cui_str': 'Cleft lip'}, {'cui': 'C0008925', 'cui_str': 'Cleft palate'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0394791', 'cui_str': 'Local anesthetic maxillary nerve block'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]",124.0,0.50448,"There was a statistically significant difference in the incidence of emergence agitation (30.2% in the CG compared to 15.2% in the CLG; difference of incidences: 15%, 95% CI: 0.1-30.1).","[{'ForeName': 'Gaston Echaniz', 'Initials': 'GE', 'LastName': 'Barbero', 'Affiliation': ""Department of Anesthesiology, 16810Vall d'Hebron Hospital, Barcelona, Spain.""}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'de Miguel', 'Affiliation': ""Department of Anesthesiology, 16810Vall d'Hebron Hospital, Barcelona, Spain.""}, {'ForeName': 'Plinio', 'Initials': 'P', 'LastName': 'Sierra', 'Affiliation': 'Department of Pediatric Anesthesia, King Abdullah Hospital, Riyadh, Saudi Arabia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Merritt', 'Affiliation': ""Department of Anesthesiology, 2932Children's Hospital Colorado, Denver, Colorado, USA.""}, {'ForeName': 'Pranjal', 'Initials': 'P', 'LastName': 'Bora', 'Affiliation': 'Department of Anesthesiology, Guwahati Comprehensive Cleft Care Center, Guwahati, India.'}, {'ForeName': 'Nabamallika', 'Initials': 'N', 'LastName': 'Borah', 'Affiliation': 'Department of Anesthesiology, Guwahati Comprehensive Cleft Care Center, Guwahati, India.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Ciarallo', 'Affiliation': ""Department of Anesthesiology, 2932Children's Hospital Colorado, Denver, Colorado, USA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ing', 'Affiliation': ""Department of Anesthesiology, 2932Children's Hospital Colorado, Denver, Colorado, USA.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Bosenberg', 'Affiliation': ""Department Anesthesiology and Pain Management, 7284Seattle Children's Hospital and University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'de Nadal', 'Affiliation': ""Department of Anesthesiology, 16810Vall d'Hebron Hospital, Barcelona, Spain.""}]",The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association,['10.1177/1055665620964141']
2120,33043697,Twelve weeks of resistance training performed with different number of sets: Effects on maximal strength and resting blood pressure of individuals with hypertension.,"Objective:  This study aimed to verify the effect of resistance training performed with single (SET1) or three sets (SET3) on muscle strength and resting blood pressure (BP) of individuals with hypertension. BP was also assessed during knee extension exercise with submaximal load before and after training.  Methods:  Thirty-eight patients with hypertension were randomly assigned to a control group (CON: n = 12; 55.6 ± 3.2 years; 65.3 ± 9.3 kg; 163.5 ± 8.6 cm), SET1 group (n = 14; 58.1 ± 2.0 years; 65.4 ± 8.7 kg; 162.4 ± 11.1 cm) or SET3 group (n = 12; 57.9 ± 2.4 years; 66.3 ± 11.4 kg; 161.6 ± 7.5 cm). The training was conducted for 12 weeks (3 d.w -1 ; 4 exercises; 12-15 repetitions; moderate intensity).  Results:  No differences were found in pre-training values for BP and strength between groups. After training, SET3 showed lower values than CON for resting systolic (121.3 ± 8.0 vs 129.3 ± 10.3 mmHg;  P  = .01) and diastolic BP (73.5 ± 6.0 vs 79.5 ± 7.4 mmHg;  P  = .02). Muscle strength in bench-press and knee extension exercises increased in SET1 (48.1 ± 6.3 and 71.3 ± 12.2 kg, respectively) and SET3 (50.2 ± 7.8 and 75.2 ± 9.6 kg, respectively) in relation to CON (39.3 ± 5.1 and 62.4 ± 9.9 kg) ( P  < .01). BP during knee extension (70% of one maximal repetition) did not differ between groups either before or after training.  Conclusion:  Resistance training with a single set could be interesting when there is a need to increase muscle strength without necessarily reducing resting BP. On the other hand, the performance of three sets increased muscle strength and reduced BP at rest in individuals with hypertension.",2020,"Muscle strength in bench-press and knee extension exercises increased in SET1 (48.1 ± 6.3 and 71.3 ± 12.2 kg, respectively) and SET3 (50.2 ± 7.8 and 75.2 ± 9.6 kg, respectively) in relation to CON (39.3 ± 5.1 and 62.4 ± 9.9 kg) ( P  < .01).","['individuals with hypertension', 'Thirty-eight patients with hypertension']","['resistance training performed with single (SET1) or three sets (SET3', 'CON', 'SET1', 'SET3']","['maximal strength and resting blood pressure', 'pre-training values for BP and strength', 'muscle strength and reduced BP', 'diastolic BP', 'resting systolic', 'muscle strength and resting blood pressure (BP', 'Muscle strength in bench-press and knee extension exercises', 'BP']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",38.0,0.0290955,"Muscle strength in bench-press and knee extension exercises increased in SET1 (48.1 ± 6.3 and 71.3 ± 12.2 kg, respectively) and SET3 (50.2 ± 7.8 and 75.2 ± 9.6 kg, respectively) in relation to CON (39.3 ± 5.1 and 62.4 ± 9.9 kg) ( P  < .01).","[{'ForeName': 'Marcos D', 'Initials': 'MD', 'LastName': 'Polito', 'Affiliation': 'Physical Education Department, Londrina State University , Londrina, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Papst', 'Affiliation': 'Physical Education Department, Londrina State University , Londrina, Brazil.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Goessler', 'Affiliation': 'Faculdade de Medicina FMUSP, Universidade de São Paulo , São Paulo, Brazil.'}]","Clinical and experimental hypertension (New York, N.Y. : 1993)",['10.1080/10641963.2020.1833024']
2121,33043883,DMT alters cortical travelling waves.,"Psychedelic drugs are potent modulators of conscious states and therefore powerful tools for investigating their neurobiology. N,N, Dimethyltryptamine (DMT) can rapidly induce an extremely immersive state of consciousness characterized by vivid and elaborate visual imagery. Here, we investigated the electrophysiological correlates of the DMT induced altered state from a pool of participants receiving DMT and (separately) placebo (saline) while instructed to keep their eyes closed. Consistent with our hypotheses, results revealed a spatio-temporal pattern of cortical activation (i.e., travelling waves) similar to that elicited by visual stimulation. Moreover, the typical top-down alpha-band rhythms of closed-eyes rest were significantly decreased, while the bottom-up forward wave was significantly increased. These results support a recent model proposing that psychedelics reduce the 'precision-weighting of priors', thus altering the balance of top-down versus bottom-up information passing. The robust hypothesis-confirming nature of these findings imply the discovery of an important mechanistic principle underpinning psychedelic-induced altered states.",2020,"Here, we investigated the electrophysiological correlates of the DMT induced altered state from a pool of participants receiving DMT and (separately) placebo (saline) while instructed to keep their eyes closed.",[],"['placebo (saline', 'Dimethyltryptamine (DMT', 'DMT']",['typical top-down alpha-band rhythms of closed-eyes rest'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0027183', 'cui_str': 'N,-N-dimethyltryptamine'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",,0.0411564,"Here, we investigated the electrophysiological correlates of the DMT induced altered state from a pool of participants receiving DMT and (separately) placebo (saline) while instructed to keep their eyes closed.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Alamia', 'Affiliation': 'CerCo, CNRS - Université de Toulouse, Toulouse, France.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Timmermann', 'Affiliation': 'Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Rufin', 'Initials': 'R', 'LastName': 'VanRullen', 'Affiliation': 'CNRS, CNRS, UMR5549, Centre de Recherche Cerveau et Cognition, Faculté de Médecine de Purpan, Toulouse, France.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Carhart-Harris', 'Affiliation': 'Psychedelic Research Group, Centre for Psychiatry, Division of Brain Sciences, Imperial College London, London, United Kingdom.'}]",eLife,['10.7554/eLife.59784']
2122,33043881,Stratified versus usual care for the management of primary care patients with sciatica: the SCOPiC RCT.,"BACKGROUND


Sciatica has a substantial impact on patients and society. Current care is 'stepped', comprising an initial period of simple measures of advice and analgesia, for most patients, commonly followed by physiotherapy, and then by more intensive interventions if symptoms fail to resolve. No study has yet tested a model of stratified care in which patients are subgrouped and matched to different care pathways based on their prognosis and clinical characteristics.
OBJECTIVES


The objectives were to investigate the clinical effectiveness and cost-effectiveness of a stratified care model compared with usual, non-stratified care.
DESIGN


This was a two-parallel group, multicentre, pragmatic, 1 : 1 randomised controlled trial.
SETTING


Participants were recruited from primary care (42 general practices) in North Staffordshire, North Shropshire/Wales and Cheshire in the UK.
PARTICIPANTS


Eligible patients were aged ≥ 18 years, had suspected sciatica, had access to a mobile phone/landline, were not pregnant, were not receiving treatment for the same problem and had not had previous spinal surgery.
INTERVENTIONS


In stratified care, a combination of prognostic and clinical criteria associated with referral to spinal specialist services was used to allocate patients to one of three groups for matched care pathways. Group 1 received advice and up to two sessions of physiotherapy, group 2 received up to six sessions of physiotherapy, and group 3 was fast-tracked to magnetic resonance imaging and spinal specialist opinion. Usual care was based on the stepped-care approach without the use of any stratification tools/algorithms. Patients were randomised using a remote web-based randomisation service.
MAIN OUTCOME MEASURES


The primary outcome was time to first resolution of sciatica symptoms (six point ordinal scale, collected via text messages). Secondary outcomes (at 4 and 12 months) included pain, function, psychological health, days lost from work, work productivity, satisfaction with care and health-care use. A cost-utility analysis was undertaken over 12 months. A qualitative study explored patients' and clinicians' views of the fast-track care pathway to a spinal specialist.
RESULTS


A total of 476 patients were randomised (238 in each arm). For the primary outcome, the overall response rate was 89.3% (88.3% and 90.3% in the stratified and usual care arms, respectively). Relief from symptoms was slightly faster (2 weeks median difference) in the stratified care arm, but this difference was not statistically significant (hazard ratio 1.14, 95% confidence interval 0.89 to 1.46;  p  = 0.288). On average, participants in both arms reported good improvement from baseline, on most outcomes, over time. Following the assessment at the research clinic, most participants in the usual care arm were referred to physiotherapy.
CONCLUSIONS


The stratified care model tested in this trial was not more clinically effective than usual care, and was not likely to be a cost-effective option. The fast-track pathway was felt to be acceptable to both patients and clinicians; however, clinicians expressed reluctance to consider invasive procedures if symptoms were of short duration.
LIMITATIONS


Participants in the usual care arm, on average, reported good outcomes, making it challenging to demonstrate superiority of stratified care. The performance of the algorithm used to allocate patients to treatment pathways may have influenced results.
FUTURE WORK


Other approaches to stratified care may provide superior outcomes for sciatica.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN75449581.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 49. See the NIHR Journals Library website for further project information.",2020,"Relief from symptoms was slightly faster (2 weeks median difference) in the stratified care arm, but this difference was not statistically significant (hazard ratio 1.14, 95% confidence interval 0.89 to 1.46;  p  = 0.288).","['primary care patients with sciatica', 'Eligible patients were aged ≥\u200918 years, had suspected sciatica, had access to a mobile phone/landline, were not pregnant, were not receiving treatment for the same problem and had not had previous spinal surgery', 'Participants were recruited from primary care (42 general practices) in North Staffordshire, North Shropshire/Wales and Cheshire in the UK', '476 patients were randomised (238 in each arm']","['SCOPiC RCT', 'physiotherapy, group 2 received up to six sessions of physiotherapy, and group 3 was fast-tracked to magnetic resonance imaging and spinal specialist opinion']","['clinical effectiveness and cost-effectiveness', 'overall response rate', 'time to first resolution of sciatica symptoms (six point ordinal scale, collected via text messages', 'pain, function, psychological health, days lost from work, work productivity, satisfaction with care and health-care use']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036396', 'cui_str': 'Sciatica'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0454875', 'cui_str': 'Staffordshire'}, {'cui': 'C0454872', 'cui_str': 'Shropshire'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0454844', 'cui_str': 'Cheshire'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}]","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036396', 'cui_str': 'Sciatica'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",476.0,0.137017,"Relief from symptoms was slightly faster (2 weeks median difference) in the stratified care arm, but this difference was not statistically significant (hazard ratio 1.14, 95% confidence interval 0.89 to 1.46;  p  = 0.288).","[{'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Kika', 'Initials': 'K', 'LastName': 'Konstantinou', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Ogollah', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Kigozi', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jowett', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Bartlam', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Artus', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Hill', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Hughes', 'Affiliation': 'Keele Clinical Trials Unit, Keele University, Keele, UK.'}, {'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Mallen', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Hay', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Danielle A', 'Initials': 'DA', 'LastName': 'van der Windt', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Keele Clinical Trials Unit, Keele University, Keele, UK.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Dunn', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24490']
2123,33043969,"Vesatolimod, a toll-like receptor 7 agonist, induces immune activation in virally suppressed adults with HIV-1.","BACKGROUND


Treatment with vesatolimod, an investigational oral toll-like receptor 7 (TLR7) agonist, leads to sustained viral remission in some non-human primates when combined with anti-envelope antibodies or therapeutic vaccines. We report results of a phase 1 study evaluating safety, pharmacokinetics, and pharmacodynamics of vesatolimod in adults living with HIV-1.
METHODS


In this double-blind, multicentre, placebo-controlled trial (ClinicalTrials.gov NCT02858401), participants on antiretroviral therapy with screening plasma HIV-1 RNA levels <50 copies/mL were randomized (6:2) to receive 6-10 doses of vesatolimod (1-12 mg) or matching placebo orally every other week in sequential dose escalation cohorts. Primary study objectives included safety and virologic effects of vesatolimod (change from baseline in plasma HIV-1 RNA). Pharmacokinetics and pharmacodynamic/immunologic activity were assessed as secondary objectives.
FINDINGS


A total of 48 individuals were randomly assigned to vesatolimod (n=36) or placebo (n=12). Vesatolimod was generally well tolerated with no study drug-related serious adverse events or adverse events leading to study discontinuation. There were no statistically significant changes from baseline in plasma HIV-1 RNA in the vesatolimod groups compared to placebo.Vesatolimod plasma exposures increased dose-proportionally; consistent responses in cytokines, interferon-stimulated gene expression, and lymphocyte activation were observed with increasing dose levels above 4 mg. Peak elevations 24 hours post 6 mg dose were >3·9-fold for IP-10, IL-1Ra, and ITAC when compared to baseline values.
INTERPRETATION


Vesatolimod was well tolerated at doses ranging from 1 to 12 mg. Immune stimulation observed at doses above 4 mg, providing rationale for future combination trials in people with HIV.",2020,"Peak elevations 24 hours post 6 mg dose were >3·9-fold for IP-10, IL-1Ra, and ITAC when compared to baseline values.
","['adults living with HIV-1', 'people with HIV', 'virally suppressed adults with HIV-1', '48 individuals', 'participants on antiretroviral therapy with screening plasma HIV-1 RNA levels <50 copies/mL']","['vesatolimod (1-12\xa0mg) or matching placebo', 'placebo', 'vesatolimod']","['cytokines, interferon-stimulated gene expression, and lymphocyte activation', 'plasma HIV-1 RNA', 'safety and virologic effects of vesatolimod (change from baseline in plasma HIV-1 RNA', 'Peak elevations', 'Pharmacokinetics and pharmacodynamic/immunologic activity', 'immune activation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C4519174', 'cui_str': 'vesatolimod'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0024262', 'cui_str': 'Blast Transformation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C4519174', 'cui_str': 'vesatolimod'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439662', 'cui_str': 'Immune'}]",48.0,0.61767,"Peak elevations 24 hours post 6 mg dose were >3·9-fold for IP-10, IL-1Ra, and ITAC when compared to baseline values.
","[{'ForeName': 'Sharon A', 'Initials': 'SA', 'LastName': 'Riddler', 'Affiliation': 'University of Pittsburgh, Department of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Para', 'Affiliation': 'The Ohio State University, Wexner Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Constance A', 'Initials': 'CA', 'LastName': 'Benson', 'Affiliation': 'University of California San Diego, Department of Medicine, San Diego, California, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mills', 'Affiliation': ""SoCal Men's Medical Group, Los Angeles, California, USA.""}, {'ForeName': 'Moti', 'Initials': 'M', 'LastName': 'Ramgopal', 'Affiliation': 'Midway Specialty Care Center, Fort Pierce, Florida, USA.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'DeJesus', 'Affiliation': 'Orlando Immunology Center, Orlando, Florida, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Brinson', 'Affiliation': 'Central Texas Clinical Research, Austin, Texas, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Cyktor', 'Affiliation': 'University of Pittsburgh, Department of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Jacobs', 'Affiliation': 'University of Pittsburgh, Department of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Dianna', 'Initials': 'D', 'LastName': 'Koontz', 'Affiliation': 'University of Pittsburgh, Department of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mellors', 'Affiliation': 'University of Pittsburgh, Department of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Laird', 'Affiliation': 'Accelevir Diagnostics, Baltimore, Maryland, USA.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Wrin', 'Affiliation': 'Monogram Biosciences, South San Francisco, California, USA.'}, {'ForeName': 'Heena', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Wallin', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Boice', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Liao', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Humeniuk', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Begley', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Polina', 'Initials': 'P', 'LastName': 'German', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Hiba', 'Initials': 'H', 'LastName': 'Graham', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Romas', 'Initials': 'R', 'LastName': 'Geleziunas', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Brainard', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'SenGupta', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1534']
2124,33044039,"Evaluation of EDTA, QMix, and Irritrol solutions activated with Er,Cr:YSGG and diode lasers on the push-out bond strength of filling material.","This study was conducted to evaluate the effects of ethylenediaminetetraacetic acid (EDTA), Irritrol, and QMix solutions used with manual irrigation and diode and erbium, chromium-doped yttrium, scandium, gallium, and garnet (Er,Cr:YSGG) laser activation on the bonding ability of sealer to the intraradicular dentin. The root canals of 90 mandibular incisors were instrumented, and the teeth were allocated randomly to nine groups (n = 10/group) receiving final irrigation with different irrigation solutions (EDTA, Irritrol, and QMix) and irrigant activation techniques (manual, diode laser, and Er,Cr:YSGG laser). Following endodontic filling, three sections of 1-mm thickness were obtained from the middle third of each root. The root filling was subjected to a push-out test to examine the bond strength of the sealer to dentin. The test data were examined using analysis of variance with a significance level of ɑ < .05. Failure modes were determined by stereomicroscopy, and the surface characteristics of dentin were observed by scanning electron microscopy. Irritrol showed less push-out bond strength than did the other solutions in the Er,Cr:YSGG laser groups (p < .05). In the diode laser groups, QMix provided greater adhesion than did Irritrol (p < .05). The activation of QMix with the Er,Cr:YSGG laser increased the bond strength more than did manual irrigation (p < .05). No other significant difference was observed between other comparison pairs (p > .05). QMix provided adhesion superior to that of Irritrol when activated with diode and Er,Cr:YSGG lasers. Er,Cr:YSGG laser activation increased the adhesion of filling material with QMix irrigation.",2020,"The activation of QMix with the Er,Cr:YSGG laser increased the bond strength more than did manual irrigation (p < .05).",['90 mandibular incisors'],"['EDTA, QMix, and Irritrol solutions activated with Er,Cr:YSGG and diode lasers', 'final irrigation with different irrigation solutions (EDTA, Irritrol, and QMix) and irrigant activation techniques (manual, diode laser, and Er,Cr:YSGG laser', 'YSGG laser activation', 'Er,Cr', 'ethylenediaminetetraacetic acid (EDTA), Irritrol, and QMix solutions used with manual irrigation and diode and erbium, chromium-doped yttrium, scandium, gallium, and garnet (Er,Cr:YSGG) laser activation']","['push-out bond strength', 'bond strength']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0036274', 'cui_str': 'Scandium'}, {'cui': 'C0016980', 'cui_str': 'Gallium'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0449263', 'cui_str': 'Activation technique'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}, {'cui': 'C0449897', 'cui_str': 'Solution used'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",90.0,0.0181346,"The activation of QMix with the Er,Cr:YSGG laser increased the bond strength more than did manual irrigation (p < .05).","[{'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Saricam', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Ankara Yildirim Beyazit University, Ankara, Turkey.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Küçük', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Near East University, Mersin, Turkey.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Akyol', 'Affiliation': 'Tepebasi Oral and Dental Health Education Hospital, Faculty of Dentistry, Ankara Yıldırım Beyazıt University, Ankara, Turkey.'}]",Microscopy research and technique,['10.1002/jemt.23616']
2125,33044041,Effect of acupressure on agitation in the elderly with dementia who receive institutional care: A pilot study.,"PURPOSE


This pilot study was carried out to determine the effect of acupressure on agitation in the elderly with dementia who receive institutional care.
METHODS


The study sample consisted of 38 elderly individuals (acupressure group [AG] = 19, usual-care group = 19). Acupressure application was performed on four points. The results were measured at the beginning (T 0  ), the week after acupressure was completed (T 1  ), and 2 weeks after acupressure was completed (T 2  ).
FINDINGS


The change in the total Cohen-Mansfield Agitation Inventory score across the groups at T 1  , T 2  , and T 3  was statistically significant in favor of AG.
PRACTICAL IMPLICATIONS


The acupressure used in this study can be used for managing agitation in the elderly with dementia.",2020,"The change in the total Cohen-Mansfield Agitation Inventory score across the groups at T 1  , T 2  , and T 3  was statistically significant in favor of AG.
","['elderly with dementia', 'elderly with dementia who receive institutional care', '38 elderly individuals (acupressure group [AG]\u2009=\u200919, usual-care group\u2009=\u200919']",['acupressure'],['total Cohen-Mansfield Agitation Inventory score'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",38.0,0.0191622,"The change in the total Cohen-Mansfield Agitation Inventory score across the groups at T 1  , T 2  , and T 3  was statistically significant in favor of AG.
","[{'ForeName': 'Serap', 'Initials': 'S', 'LastName': 'Bayram', 'Affiliation': 'Department of Health Care Services, Vocational School of Health Services, Düzce University, Düzce, Turkey.'}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Altınbaş Akkaş', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Düzce University, Düzce, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Usta', 'Affiliation': 'Department of Health Care Services, Vocational School of Health Services, Düzce University, Düzce, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12642']
2126,33044102,Method for evaluating the human bioequivalence of acarbose based on pharmacodynamic parameters.,"OBJECTIVE


To explore a method for evaluating the bioequivalence of acarbose based on pharmacodynamic parameters using a single-dose, randomized-sequence, three-way crossover study of acarbose test (T) and reference (R) formulations.
METHODS


Baseline-adjusted, pre-dose value deduction, and direct comparison methods were used to evaluate the geometric T/R ratios and 90% confidence intervals (CIs) of the ln-transformed pharmacodynamic parameters to identify the most suitable evaluation system. Twelve participants were randomly divided into three groups to receive treatment in the following sequences: TRR, RTR, and RRT, each including a 7-day washout period between treatment periods. The serum glucose concentration (baseline) was determined. Pharmacodynamic parameters, including the maximum reduction in serum glucose concentrations (ΔC SG,max ) and difference of the AUC of glucose between before and after acarbose exposure (ΔAUEC), were tested.
RESULTS


Using the direct comparison method, the geometric mean ratios of C SG,max , AUEC (0-2h) , and AUEC (0-4h)  were 94.13%, 97.82% and 99.76%, respectively. The 90% CIs of the geometric T/R ratios for C SG,max , AUEC (0-2h),  and AUEC (0-4h)  all fell between 80% and 125%. Conversely, ΔC SG,max  and ΔAUEC (0-4h)  were less reliable measures of acarbose bioequivalence.
CONCLUSIONS


Pre-dose value deduction and direct comparison methods can be initially considered suitable for assessing acarbose bioequivalence.",2020,"Conversely, ΔC SG,max  and ΔAUEC (0-4h)  were less reliable measures of acarbose bioequivalence.
",['Twelve participants'],"['acarbose test (T) and reference (R) formulations', 'acarbose']","['geometric mean ratios of C SG,max , AUEC (0-2h) , and AUEC (0-4h', 'geometric T/R ratios for C SG,max , AUEC (0-2h),  and AUEC', 'serum glucose concentrations (ΔC SG,max ) and difference of the AUC of glucose', 'Conversely, ΔC SG,max  and ΔAUEC', 'serum glucose concentration (baseline']",[],"[{'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",12.0,0.0163034,"Conversely, ΔC SG,max  and ΔAUEC (0-4h)  were less reliable measures of acarbose bioequivalence.
","[{'ForeName': 'Su-Mei', 'Initials': 'SM', 'LastName': 'Xu', 'Affiliation': 'National Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.'}, {'ForeName': 'Yu-Ying', 'Initials': 'YY', 'LastName': 'Xu', 'Affiliation': 'National Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'National Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.'}, {'ForeName': 'Yi-Fei', 'Initials': 'YF', 'LastName': 'Zhang', 'Affiliation': 'School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'National Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'National Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.'}, {'ForeName': 'Xiao-Min', 'Initials': 'XM', 'LastName': 'Li', 'Affiliation': 'National Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'National Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.'}, {'ForeName': 'Ping-Sheng', 'Initials': 'PS', 'LastName': 'Xu', 'Affiliation': 'National Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.'}]",The Journal of international medical research,['10.1177/0300060520960317']
2127,33031860,Believing is achieving - On the role of treatment expectation in neurofeedback applications.,"In neurofeedback applications, neural activity is recorded, processed in real-time and fed back to the user in order to facilitate self-regulation of the putative neural mechanisms that underlie cognition and behavior. Numerous studies suggest that neurofeedback interventions are an efficacious treatment particularly for patients with attention-deficit/hyperactivity disorder (ADHD). In recent years, however, findings of several well-controlled studies raised doubts concerning the proposed mechanism of action behind the behavioral effect of neurofeedback. This study investigated the impact of expectation on the efficacy of a sensorimotor rhythm (SMR) training. In a within-subjects design 30 blinded volunteers with ADHD symptoms received a standard SMR training session after inducing no (no-expectancy condition), positive (placebo condition), and negative (nocebo condition) expectations regarding the effectiveness of neurofeedback (by telling them that they would train a specific frequency band that was previously shown to be either unrelated to attention, should improve attention, or interfere with attentional processes). After each training, participants were presented with a cognitive test and subsequently requested to rate their performance on it. We could show that participants were able to successfully modify their EEG signal during training. Further, we found an effect over trainings on objective attentional performance. Most importantly, we found that the expectancy of positive or negative treatment effects considerably changed participants' perception of neurofeedback's efficacy even in the absence of any objective evidence. This study presents strong first evidence for a substantial effect of self-confirming response expectancies as one factor underlying the efficacy of neurofeedback. Future research has to carefully consider the impact of such psychosocial mechanisms when evaluating the (specific) efficacy of neuromodulatory treatments.",2020,"Most importantly, we found that the expectancy of positive or negative treatment effects considerably changed participants' perception of neurofeedback's efficacy even in the absence of any objective evidence.",['patients with attention-deficit/hyperactivity disorder (ADHD'],"['standard SMR training session after inducing no (no-expectancy condition), positive (placebo condition), and negative (nocebo condition) expectations', 'sensorimotor rhythm (SMR) training', 'neurofeedback interventions']",['objective attentional performance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}]",30.0,0.0296425,"Most importantly, we found that the expectancy of positive or negative treatment effects considerably changed participants' perception of neurofeedback's efficacy even in the absence of any objective evidence.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schönenberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Germany. Electronic address: michael.schoenenberg@uni-tuebingen.de.'}, {'ForeName': 'Anna-Lena', 'Initials': 'AL', 'LastName': 'Weingärtner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weimer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Center, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Scheeff', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Germany.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110129']
2128,33032009,Step-stress vs. staircase fatigue tests to evaluate the effect of intaglio adjustment on the fatigue behavior of simplified lithium disilicate glass-ceramic restorations.,"The aim of the study was to compare the outcomes for the fatigue mechanical behavior of bonded simplified lithium disilicate restorations, with and without an internal adjustment by grinding with diamond bur in running two fatigue tests: Staircase and Step-stress testing approaches. Ceramic discs (IPS e.max CAD) were prepared (Ø = 10 mm; thickness = 1.0 mm), submitted to an in-lab simulation of CAD/CAM milling (#60 SiC paper) and allocated into 2 groups according to the internal adjustment by grinding of the cementation surface: no adjustment (CTRL); or grinding with a coarse diamond bur (GR). Adhesive cementation (Multilink N) was performed onto epoxy resin discs (Ø = 10 mm; thickness = 2 mm) after ceramic/epoxy surface treatments. The cemented assemblies of each group were randomly assigned into 2 subgroups considering two fatigue tests (n = 15): Staircase - SC (250,000 cycles; 20 Hz), or Step-stress - SS (10,000 cycles per step; 20 Hz). Roughness, topographic and fractographic analyses were additionally performed. Statistical analyses were carried out using the Dixon and Mood method for Staircase data, and Kaplan-Meier and Mantel-Cox (log-rank) tests for Step-stress data. Ceramic restorations having its intaglio surface ground (GR group: SC test = 306.67 N; SS test = 646.67 N) presented lower fatigue failure load (FFL) values than the CTRL group (SC test = 879.28 N; SS test = 1090.00 N), regardless of the fatigue testing approach. The percentage of mean FFL decrease comparing the CTRL to GR group was higher for SC (65.1%) than the SS (40.7%) approach. However, a different total number of cycles was applied for each method. Both fatigue tests were able to detect the negative effect of internal adjustments of lithium disilicate glass-ceramic simplified restorations on their mechanical behavior. Therefore, both methods can be applied for similar evaluations (fatigue testing for ceramic restorations).",2020,Both fatigue tests were able to detect the negative effect of internal adjustments of lithium disilicate glass-ceramic simplified restorations on their mechanical behavior.,[],"['Staircase - SC (250,000 cycles; 20\xa0Hz), or Step-stress - SS', 'Adhesive cementation (Multilink N', 'internal adjustment by grinding of the cementation surface: no adjustment (CTRL); or grinding with a coarse diamond bur (GR', 'Ceramic discs (IPS e.max CAD']","['percentage of mean FFL decrease', 'Roughness, topographic and fractographic analyses', 'fatigue failure load (FFL) values']",[],"[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0007656', 'cui_str': 'Cementation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205194', 'cui_str': 'Coarse'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0283014,Both fatigue tests were able to detect the negative effect of internal adjustments of lithium disilicate glass-ceramic simplified restorations on their mechanical behavior.,"[{'ForeName': 'Andressa Borin', 'Initials': 'AB', 'LastName': 'Venturini', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: andressa.venturini@hotmail.com.'}, {'ForeName': 'Thaís Camponogara', 'Initials': 'TC', 'LastName': 'Bohrer', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: thaiscbohrer@hotmail.com.'}, {'ForeName': 'Patrícia Eliana', 'Initials': 'PE', 'LastName': 'Fontana', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: patricia_fontana_@hotmail.com.'}, {'ForeName': 'Tatiana Tambara', 'Initials': 'TT', 'LastName': 'Fröhlich', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: frohlichtatiana@gmail.com.'}, {'ForeName': 'Liliana Gressler', 'Initials': 'LG', 'LastName': 'May', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: liligmay@gmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.104091']
2129,33034564,Effect of Smartphone-Based Lifestyle Coaching App on Community-Dwelling Population With Moderate Metabolic Abnormalities: Randomized Controlled Trial.,"BACKGROUND


Metabolic disorders are established precursors to cardiovascular diseases, yet they can be readily prevented with sustained lifestyle modifications.
OBJECTIVE


We assessed the effectiveness of a smartphone-based weight management app on metabolic parameters in adults at high-risk, yet without physician diagnosis nor pharmacological treatment for metabolic syndrome, in a community setting.
METHODS


In this 3-arm parallel-group, single-blind, randomized controlled trial, we recruited participants aged 30 to 59 years with at least 2 conditions defined by the Third Report of the National Cholesterol Education Program expert panel (abdominal obesity, high blood pressure, high triglycerides, low high-density lipoprotein cholesterol, and high fasting glucose level). Participants were randomly assigned (1:1:1) by block randomization to either the nonuser group (control), the app-based diet and exercise self-logging group (app only), or the app-based self-logging and personalized coaching from professional dieticians and exercise coordinators group (app with personalized coaching). Assessments were performed at baseline, week 6, week 12, and week 24. The primary outcome was change in systolic blood pressure (between baseline and follow-up assessments). Secondary outcomes were changes in diastolic blood pressure, body weight, body fat mass, waist circumference, homeostatic model of assessment of insulin resistance, triglyceride level, and high-density lipoprotein cholesterol level between baseline and follow-up assessments. Analysis was performed using intention-to-treat.
RESULTS


Between October 28, 2017 and May 28, 2018, 160 participants participated in the baseline screening examination. Participants (129/160, 80.6%) who satisfied the eligibility criteria were assigned to control (n=41), app only (n=45), or app with personalized coaching (n=43) group. In each group, systolic blood pressure showed decreasing trends from baseline (control: mean -10.95, SD 2.09 mmHg; app only: mean -7.29, SD 1.83 mmHg; app with personalized coaching: mean -7.19, SD 1.66 mmHg), yet without significant difference among the groups (app only: P=.19; app with personalized coaching: P=.16). Instead, those in the app with personalized coaching group had greater body weight reductions (control: mean -0.12, SD 0.30 kg; app only: mean -0.35, SD 0.36 kg, P=.67; app with personalized coaching: mean -0.96, SD 0.37 kg; P=.08), specifically by body fat mass reduction (control: mean -0.13, SD 0.34 kg; app only: mean -0.64, SD 0.38 kg, P=.22; app with personalized coaching: mean -0.79, SD 0.38 kg; P=.08).
CONCLUSIONS


Simultaneous diet and exercise self-logging and persistent lifestyle modification coaching were ineffective in lowering systolic blood pressure but effective in losing weight and reducing body fat mass. These results warrant future implementation studies of similar models of care on a broader scale in the context of primary prevention.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03300271; http://clinicaltrials.gov/ct2/show/NCT03300271.",2020,"mean -0.96, SD 0.37 kg; P=.08), specifically by body fat mass reduction (control: mean -0.13, SD 0.34 kg; app only:","['Participants (129/160, 80.6%) who satisfied the eligibility criteria were assigned to control (n=41), app only (n=45), or app with', '160 participants participated in the baseline screening examination', 'Community-Dwelling Population With Moderate Metabolic Abnormalities', 'participants aged 30 to 59 years with at least 2 conditions defined by the Third Report of the National Cholesterol Education Program expert panel (abdominal obesity, high blood pressure, high triglycerides, low high-density lipoprotein cholesterol, and high fasting glucose level', 'adults at high-risk, yet without physician diagnosis nor pharmacological treatment for metabolic syndrome, in a community setting', 'Between October 28, 2017 and May 28, 2018']","['Simultaneous diet and exercise self-logging and persistent lifestyle modification coaching', 'smartphone-based weight management app', 'Smartphone-Based Lifestyle Coaching App', 'block randomization to either the nonuser group (control), the app-based diet and exercise self-logging group (app only), or the app-based self-logging and personalized coaching from professional dieticians and exercise coordinators group (app with personalized coaching', 'personalized coaching']","['body weight reductions', 'diastolic blood pressure, body weight, body fat mass, waist circumference, homeostatic model of assessment of insulin resistance, triglyceride level, and high-density lipoprotein cholesterol level', 'systolic blood pressure', 'metabolic parameters']","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0151691', 'cui_str': 'High density lipoprotein decreased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",160.0,0.120663,"mean -0.96, SD 0.37 kg; P=.08), specifically by body fat mass reduction (control: mean -0.13, SD 0.34 kg; app only:","[{'ForeName': 'So Mi Jemma', 'Initials': 'SMJ', 'LastName': 'Cho', 'Affiliation': 'Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, the Graduate School of Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Jee-Seon', 'Initials': 'JS', 'LastName': 'Shim', 'Affiliation': 'Cardiovascular and Metabolic Diseases Etiology Research Center, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyungseon', 'Initials': 'H', 'LastName': 'Yeom', 'Affiliation': 'Department of Medicine, the Graduate School of Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Su Jin', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yong Woo', 'Initials': 'YW', 'LastName': 'Jeon', 'Affiliation': 'Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyeon Chang', 'Initials': 'HC', 'LastName': 'Kim', 'Affiliation': 'Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Journal of medical Internet research,['10.2196/17435']
2130,33034565,Evaluating the Implementation of a Remote-Monitoring Program for Chronic Obstructive Pulmonary Disease: Qualitative Methods from a Service Design Perspective.,"BACKGROUND


Implementing digital health technologies is complex but can be facilitated by considering the features of the tool that is being implemented, the team that will use it, and the routines that will be affected.
OBJECTIVE


The goal of this study was to assess the implementation of a remote-monitoring initiative for patients with chronic obstructive pulmonary disease in Ontario, Canada using the Tool+Team+Routine framework and to refine this approach to conceptualize the adoption of technologies in health care.
METHODS


This study was a qualitative research project that took place alongside a randomized controlled trial comparing a technology-enabled self-monitoring program with a technology-enabled self- and remote-monitoring program in patients with chronic obstructive pulmonary disease and with standard care. This study included interviews with 5 remote-monitoring patients, 3 self-monitoring patients, 2 caregivers, 5 health care providers, and 3 hospital administrators. The interview questions were structured around the 3 main concepts of the Tool+Team+Routine framework.
RESULTS


Findings emphasized that (1) technologies can alter relationships between providers and patients, and that these relationships drove the development of a new service arising from the technology, in our case, and (2) technologies can create additional work that is not visible to management as a result of not being considered within the scope of the service.
CONCLUSIONS


Literature on the implementation of digital health technologies has still not reconciled the importance of interpersonal relationships to conventional implementation strategies. By acknowledging the centrality of such relationships, implementation teams can better plan for the adaptations required in order to make new technologies work for patients and health care providers. Further work will need to address how specific individuals administering a remote-monitoring program work to build relationships, and how these relationships and other sources of activity might lead to technological scope creep-an unanticipated expanding scope of work activities in relation to the function of the tool.",2020,"CONCLUSIONS


Literature on the implementation of digital health technologies has still not reconciled the importance of interpersonal relationships to conventional implementation strategies.","['Chronic Obstructive Pulmonary Disease', 'patients and health care providers', 'patients with chronic obstructive pulmonary disease in Ontario, Canada using the Tool+Team+Routine framework', 'patients with chronic obstructive pulmonary disease and with standard care', 'interviews with 5 remote-monitoring patients, 3 self-monitoring patients, 2 caregivers, 5 health care providers, and 3 hospital administrators']","['Remote-Monitoring Program', 'technology-enabled self-monitoring program with a technology-enabled self- and remote-monitoring program']",[],"[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0019949', 'cui_str': 'Hospital administrator'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",[],5.0,0.0261161,"CONCLUSIONS


Literature on the implementation of digital health technologies has still not reconciled the importance of interpersonal relationships to conventional implementation strategies.","[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'van Lieshout', 'Affiliation': 'University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'Vess', 'Initials': 'V', 'LastName': 'Stamenova', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'Payal', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cornejo Palma', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Sidhu', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Engel', 'Affiliation': 'Markham Stoufville Hospital, Markham, ON, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Erwood', 'Affiliation': 'Markham Stoufville Hospital, Markham, ON, Canada.'}, {'ForeName': 'R Sacha', 'Initials': 'RS', 'LastName': 'Bhatia', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'Onil', 'Initials': 'O', 'LastName': 'Bhattacharyya', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shaw', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}]",Journal of medical Internet research,['10.2196/18148']
2131,33036674,Neurectomy versus Nerve Sparing in Open Inguinal Hernia Repair: A Randomised Controlled Trial.,"OBJECTIVE


To determine the effect of neurectomy in reducing the frequency of chronic inguinodynia after mesh hernioplasty in open inguinal hernia repair.
STUDY DESIGN


Single blind randomised controlled-trial.
PLACE AND DURATION OF STUDY


Surgical Unit-I, Department of General Surgery, Services Hospital, Lahore, Pakistan from September 2018 to September 2019.
METHODOLOGY


All male patients undergoing open groin hernia surgery were included in the study. A total of 100 patients were randomly categorised into group A (neurectomy group) and group B (nerve sparing group). Patients were followed up for three months for the development of chronic inguinodynia. Signifiance was determined at p <0.05 using Chi-square and Fisher's exact tests.
RESULTS


Out of 100 patients, 50 patients were enrolled in group A, while 50 were enrolled in group B. Mean age of patients was 42.1 ± 17.5 years. The median (IQR) acute pain score in neurectomy group was 3.0 (2.0-4.0), while median (IQR) acute pain score was 4.0 (3.0-6.0) in nerve sparing group with statistically significant difference (z = -3.256, p = 0.001). The frequency of chronic inguinodynia was significantly less in group A compared to group B [3 (6%) vs. 13 (26%), p = 0.012].
CONCLUSION


Excision of ilioinguinal and iliohypogastric nerve in inguinal mesh hernioplasty reduces the frequency of chronic inguinodynia. Ilioinguinal neurectomy may be practised routinely in patients undergoing Lichtenstein mesh hernioplasty.   Key Words: Inguinal neurectomy, Inguinal hernia, Chronic inguinodynia, Lichtenstein mesh hernioplasty.",2020,"The frequency of chronic inguinodynia was significantly less in group A compared to group B [3 (6%) vs. 13 (26%), p = 0.012].
","['100 patients, 50 patients were enrolled in group A, while 50 were enrolled in group', 'B. Mean age of patients was 42.1 ± 17.5 years', '100 patients', 'All male patients undergoing open groin hernia surgery', 'patients undergoing Lichtenstein mesh hernioplasty']","['Ilioinguinal neurectomy', 'Neurectomy versus Nerve Sparing in Open Inguinal Hernia Repair', 'Surgical Unit', 'randomly categorised into group A (neurectomy group) and group B (nerve sparing group', 'Inguinal neurectomy, Inguinal hernia, Chronic inguinodynia, Lichtenstein mesh hernioplasty', 'ilioinguinal and iliohypogastric nerve in inguinal mesh hernioplasty']","['median (IQR) acute pain score', 'frequency of chronic inguinodynia']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}]","[{'cui': 'C0196652', 'cui_str': 'Nerve excision'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0228903', 'cui_str': 'Structure of iliohypogastric nerve'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}]",100.0,0.134133,"The frequency of chronic inguinodynia was significantly less in group A compared to group B [3 (6%) vs. 13 (26%), p = 0.012].
","[{'ForeName': 'Shabbar Hussain', 'Initials': 'SH', 'LastName': 'Changazi', 'Affiliation': 'Department of General Surgery, Services Hospital, Lahore, Pakistan.'}, {'ForeName': 'Nafeesah', 'Initials': 'N', 'LastName': 'Fatimah', 'Affiliation': 'Department of General Surgery, Services Hospital, Lahore, Pakistan.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Naseer', 'Affiliation': 'Department of General Surgery, Services Hospital, Lahore, Pakistan.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Wadood', 'Affiliation': 'Department of General Surgery, Services Hospital, Lahore, Pakistan.'}, {'ForeName': 'Qamar Ashfaq', 'Initials': 'QA', 'LastName': 'Ahmad', 'Affiliation': 'Department of General Surgery, Services Hospital, Lahore, Pakistan.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Ayyaz', 'Affiliation': 'Department of General Surgery, Services Hospital, Lahore, Pakistan.'}]",Journal of the College of Physicians and Surgeons--Pakistan : JCPSP,['10.29271/jcpsp.2020.09.917']
2132,33036701,"Effect of long-term omega-3 supplementation and a lifestyle multidomain intervention on intrinsic capacity among community-dwelling older adults: Secondary analysis of a randomized, placebo-controlled trial (MAPT study).","OBJECTIVES


To investigate the effect of omega-3 (ω-3) polyunsaturated fatty acid supplementation and a multidomain intervention (MI) (physical activity counselling, cognitive training and nutritional advice) among community-dwelling older adults on levels of intrinsic capacity (IC), a construct recently proposed by the World Health Organization.
STUDY DESIGN


Secondary analysis from the factorial-design 3-year Multidomain Alzheimer Preventive Trial (MAPT) with 1445 subjects (64.2 % female, mean age 75.3 years, SD = 4.4) randomized to one group of MI plus ω-3 (800 mg docosahexaenoic acid and 225 mg eicosapentaenoic acid/day); MI plus placebo; ω-3 supplementation alone; or placebo alone. Data collection was held between 2008 and 2014.
MAIN OUTCOME MEASURES


IC domains were examined with the Geriatric Depression Scale (psychological); Short Physical Performance Battery (mobility); Z-score combining four tests (cognitive function); and handgrip strength (vitality). All domains were combined into a composite IC Z-score.
RESULTS


After 3 years, IC Z-score decreased among all groups when time was considered continuous (MI plus ω-3: -0.16, 95 %CI: -0.22 to -0.10; MI alone: -0.13, 95 %CI: -0.19 to -0.07; ω-3 alone: -0.19, 95 %CI: -0.25 to -0.10; placebo: -0.20, 95 %CI: -0.26 to -0.14; all p < 0.0001). There were no significant differences between groups. In a sensitivity analysis with categorical time, significant within-group declines were first identified at 24 months for all groups.
CONCLUSIONS


This trial designed to improve cognitive function was unable to find effects of the intervention on the composite IC Z-score. Further investigations are needed, especially trials providing stronger interventions (such as exercise training and a controlled diet) and also embracing the sensorial domain of IC.",2020,"After 3 years, IC Z-score decreased among all groups when time was considered continuous (MI plus ω-3:","['Secondary analysis from the factorial-design 3-year Multidomain Alzheimer Preventive Trial (MAPT) with 1445 subjects (64.2 % female, mean age 75.3 years, SD = 4.4', 'community-dwelling older adults']","['placebo', 'MI plus ω-3 (800 mg docosahexaenoic acid and 225 mg eicosapentaenoic acid/day); MI plus placebo; ω-3 supplementation alone; or placebo alone', 'long-term omega-3 supplementation and a lifestyle multidomain intervention', 'omega-3 (ω-3) polyunsaturated fatty acid supplementation and a multidomain intervention (MI) (physical activity counselling, cognitive training and nutritional advice']","['intrinsic capacity', 'cognitive function', 'IC Z-score', 'Short Physical Performance Battery (mobility); Z-score combining four tests (cognitive function); and handgrip strength (vitality', 'Geriatric Depression Scale (psychological', 'intrinsic capacity (IC']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",,0.119789,"After 3 years, IC Z-score decreased among all groups when time was considered continuous (MI plus ω-3:","[{'ForeName': 'K V', 'Initials': 'KV', 'LastName': 'Giudici', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France. Electronic address: kellygiudici@gmail.com.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'de Souto Barreto', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France; UPS/Inserm UMR1027, University of Toulouse III, Toulouse, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Beard', 'Affiliation': 'University of Sydney, Sydney, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cantet', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France; UPS/Inserm UMR1027, University of Toulouse III, Toulouse, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Araujo de Carvalho', 'Affiliation': 'Department of Ageing and Life Course, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France; UPS/Inserm UMR1027, University of Toulouse III, Toulouse, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France; UPS/Inserm UMR1027, University of Toulouse III, Toulouse, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Maturitas,['10.1016/j.maturitas.2020.06.012']
2133,32538115,Paclitaxel coated-balloon (PCB) versus standard plain old balloon (POB) fistuloplasty for failing dialysis access.,"INTRODUCTION


This study aimed to evaluate the safety and efficacy of paclitaxel-coated balloon compared with conventional plain balloon for the treatment of failing native dialysis access.
MATERIALS AND METHODS


This prospective study included 60 patients presenting to the Kasr Alainy Hospitals and Aseer Central Hospital in the period from September 2015 to December 2017 with failing native vascular access. Dilatation with a plain balloon was done in 30 patients (group I) and with a paclitaxel-coated balloon in 30 patients (group II) with either stenosis or occlusion. The majority were outflow lesions, with 20 (66.7 %) patients in group I and 21 (70%) patients in group II. Mean balloon diameter was 7.1mm (± 1.5mm) compared with 6.5mm (± 1.2mm) and length 66mm (± 19.1mm) compared with 54.6mm (± 15.7mm), respectively. Safety endpoint was reported as 30 day's freedom from procedure-related major complications and mortality. Procedural technical success was defined as a residual diameter 30% or less for treated lesions. Target lesion primary patency, circuit primary patency and secondary patency were reported at 3, 6 and 12 months.
RESULTS


There were no 30-day procedure-related major complications or mortality in either group. Procedural technical success of 100% was achieved in both groups. Target lesion primary patency, circuit primary patency and secondary patency in group II were better than in group I, especially at 12 months (90% vs 66.7%, 83.3% vs 60% and 96.7% vs 93.3%, respectively). There was a statistically significant difference in target lesion primary patency ( p  = 0.029) in patients who were treated with paclitaxel-coated balloon angioplasties.
CONCLUSION


The paclitaxel-coated balloon proved to be safe and effective, and improved the patency of failing vascular access. Results are comparable with previous studies.",2020,"Target lesion primary patency, circuit primary patency and secondary patency in group II were better than in group",['60 patients presenting to the Kasr Alainy Hospitals and Aseer Central Hospital in the period from September 2015 to December 2017 with failing native vascular access'],"['plain balloon', 'paclitaxel-coated balloon', 'conventional plain balloon', 'stenosis or occlusion', 'Paclitaxel coated-balloon (PCB) versus standard plain old balloon (POB) fistuloplasty']","['Mean balloon diameter', '30-day procedure-related major complications or mortality', 'target lesion primary patency', 'Target lesion primary patency, circuit primary patency and secondary patency', 'safety and efficacy', 'Procedural technical success']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449851', 'cui_str': 'Technique'}]",60.0,0.0264612,"Target lesion primary patency, circuit primary patency and secondary patency in group II were better than in group","[{'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Karmota', 'Affiliation': 'Faculty of Medicine, Kasr Alainy - Cairo University Hospitals, Cairo, Egypt.'}]",Annals of the Royal College of Surgeons of England,['10.1308/rcsann.2020.0121']
2134,32070210,Effectiveness of a pharmaceutical instruction video for adherence to dermatopathy treatment in patients with cancer receiving the anti-epidermal growth factor receptor antibody.,"BACKGROUND


Dermatopathy develops as a side effect in patients receiving anti-epidermal growth factor receptor antibody treatment. Topical moisturizers are used for the prevention and treatment of this dermatopathy. Active participation of patients in their own treatment is important for the appropriate application of topical preparations. We prepared a pharmaceutical instructional video for adhering to the topical application protocol. In this study, we investigated the effectiveness of this pharmaceutical instructional video on treatment adherence.
METHODS


Study participants were patients with cancer receiving the anti-epidermal growth factor receptor antibody for the first time. A pharmacist instructed the patients on how to use the pharmaceutical instruction video. Daily topical preparation use following the video demonstration was assessed. The effectiveness of the pharmaceutical instruction video was evaluated by assessing the adherence of patients who did not use the pharmaceutical instruction video for the past 2 periods (26 months; controls 1 and 2). The incidence of side effects was compared between the two control groups and the group of patients who received the pharmaceutical instruction video.
RESULTS


The amount of topical preparation consumed (median, g/day) by patients who received patient compliance instructions using the pharmaceutical instruction video was 9.8 g/day, as compared with control group 1 (4.5 g/day) and control group 2 (5.5 g/day) ( p  <   0.001). There was no difference in the incidence of side effects during the three periods.
CONCLUSION


The use of visual instructional media for patient compliance by pharmacists may be effective in maintaining and improving treatment adherence.",2020,The effectiveness of the pharmaceutical instruction video was evaluated by assessing the adherence of patients who did not use the pharmaceutical instruction video for the past 2 periods (26 months; controls 1 and 2).,"['Study participants were patients with cancer receiving the anti-epidermal growth factor receptor antibody for the first time', 'patients receiving anti-epidermal growth factor receptor antibody treatment', 'patients who did not use the pharmaceutical instruction video for the past 2 periods (26\u2009months; controls 1 and 2', 'patients with cancer receiving the anti-epidermal growth factor receptor antibody']","['visual instructional media', 'pharmaceutical instructional video', 'pharmaceutical instruction video']",['incidence of side effects'],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.0273452,The effectiveness of the pharmaceutical instruction video was evaluated by assessing the adherence of patients who did not use the pharmaceutical instruction video for the past 2 periods (26 months; controls 1 and 2).,"[{'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Sato', 'Affiliation': 'Department of Pharmacy, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Pharmacy, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Yasuda', 'Affiliation': 'Department of Pharmacy, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Rei', 'Initials': 'R', 'LastName': 'Tanaka', 'Affiliation': 'Department of Pharmacy, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Kiyohara', 'Affiliation': 'Department of Dermatology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamawaki', 'Affiliation': 'Department of Drug Discovery Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Endo', 'Affiliation': 'Oshika Pharmacy KRAFT, Inc., Tochigi, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Shino', 'Affiliation': 'Department of Pharmacy, Shizuoka Cancer Center, Shizuoka, Japan.'}]",Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners,['10.1177/1078155220904149']
2135,33037990,Once-weekly vs. twice-weekly carfilzomib dosing in a subgroup of Japanese relapsed and refractory multiple myeloma patients from a randomized phase 3 trial (A.R.R.O.W.) and comparison with ENDEAVOR.,"A.R.R.O.W. evaluated the superiority of once-weekly carfilzomib plus dexamethasone (Kd) 20/70 mg/m 2  vs. twice-weekly Kd 20/27 mg/m 2  based on progression-free survival (PFS) in relapsed and/or refractory multiple myeloma patients. Forty Japanese patients (once-weekly arm, n = 26; twice-weekly arm, n = 14) were randomized in A.R.R.O.W. In the Japanese subgroup of A.R.R.O.W., median PFS was 14.8 months (95% confidence interval [CI], 7.5-not evaluable [NE]) and 9.7 months (95% CI, 3.8-NE) in the once- and twice-weekly arms, respectively. The overall response rate (ORR) was 73.1% (19/26; 95% CI, 52.2-88.4) and 57.1% (8/14; 95% CI, 28.9-82.3) in each arm. The adverse events (AEs) incidence was 100% in both arms. Grade ≥ 3 AE incidence was 80.8% (21/26) and 78.6% (11/14) in each arm. Two fatal treatment-related AEs (acute lung injury and acute respiratory distress syndrome) occurred in the once-weekly arm. In exploratory unadjusted analyses of A.R.R.O.W. (once-weekly Kd 20/70 mg/m 2 ) vs. ENDEAVOR (twice-weekly Kd 20/56 mg/m 2 ), median PFS was 14.8 months vs. NE due to not yet being reached, and ORR was 73.1% (19/26) vs. 42.9% (3/7). In the Japanese subgroup, once-weekly Kd tended to improve ORR vs. twice-weekly Kd. Results from A.R.R.O.W. tended to be consistent with results from ENDEAVOR.",2020,Two fatal treatment-related AEs (acute lung injury and acute respiratory distress syndrome) occurred in the once-weekly arm.,"['Forty Japanese patients (once-weekly arm, n\u2009=\u200926; twice-weekly arm, n\u2009=\u200914', 'relapsed and/or refractory multiple myeloma patients']",['carfilzomib plus dexamethasone (Kd'],"['fatal treatment-related AEs (acute lung injury and acute respiratory distress syndrome', 'Grade\u2009≥', 'overall response rate (ORR', 'ORR', 'adverse events (AEs) incidence', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}]","[{'cui': 'C2001856', 'cui_str': 'carfilzomib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",40.0,0.282537,Two fatal treatment-related AEs (acute lung injury and acute respiratory distress syndrome) occurred in the once-weekly arm.,"[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Takezako', 'Affiliation': 'National Hospital Organization Disaster Medical Center, 3256 Midori, Tachikawa, Tokyo, 190-0014, Japan. ntakezak@tdmc.hosp.go.jp.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Shibayama', 'Affiliation': 'Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Handa', 'Affiliation': 'Gunma University Graduate School, Maebashi, Japan.'}, {'ForeName': 'Shotaro', 'Initials': 'S', 'LastName': 'Hagiwara', 'Affiliation': ""Tokyo Women's University, Tokyo, Japan.""}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Ozaki', 'Affiliation': 'Tokushima Prefectural Central Hospital, Tokushima, Japan.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Japanese Red Cross Medical Center, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kosugi', 'Affiliation': 'Ogaki Municipal Hospital, Ogaki, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Ri', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Sugiura', 'Affiliation': 'Toyohashi Municipal Hospital, Toyohashi, Japan.'}, {'ForeName': 'Ilseung', 'Initials': 'I', 'LastName': 'Choi', 'Affiliation': 'National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Miyamoto', 'Affiliation': 'Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}]",International journal of hematology,['10.1007/s12185-020-03013-6']
2136,33035075,Acceptability and Feasibility of an Isometric Resistance Exercise Program for Abdominal Cancer Surgery: An Embedded Qualitative Study.,"Although it is recognized in the early stages of cancer recovery that changes in lifestyle including increases in physical activity improves physical function, there are no clear findings whether low versus moderate intensity activity or home or gym exercise offer optimal benefit. Isometric-resistance exercises can be carried out with very little equipment and space and can be performed while patients are bed-bound in hospital or at home. This embedded qualitative study, based in an English hospital trust providing specialist cancer care, was undertaken as a component of a feasibility trial to evaluate the acceptability and feasibility of an isometric-resistance exercise program and explore the suitability of functional assessments by drawing from the experiences of abdominal cancer patients following surgery. Telephone interviews were undertaken with 7 participants in the intervention group, and 8 interviews with the usual care group (n = 15). The gender composition consisted of 11 females and 4 males. Participants' ages ranged from 27 to 84 (M = 60.07, SD = 15.40). Interviews were conducted between August 2017 and May 2018, with audio files digitally recorded and data coded using thematic framework analysis. Our results show that blinding to intervention or usual care was a challenge, participants felt the intervention was safe and suitable aided by the assistance of a research nurse, yet, found the self-completion questionnaire tools hard to complete. Our study provides an insight of trial processes, participants' adherence and completion of exercise interventions, and informs the design and conduct of larger RCTs based on the experiences of abdominal cancer surgery patients.",2020,"Our results show that blinding to intervention or usual care was a challenge, participants felt the intervention was safe and suitable aided by the assistance of a research nurse, yet, found the self-completion questionnaire tools hard to complete.","['11 females and 4 males', 'abdominal cancer surgery patients', 'Abdominal Cancer Surgery', 'abdominal cancer patients following surgery', ""Participants' ages ranged from 27 to 84 (M = 60.07, SD = 15.40""]","['isometric-resistance exercise program', 'Isometric Resistance Exercise Program', 'Isometric-resistance exercises']",['Acceptability and Feasibility'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0153662', 'cui_str': 'Malignant neoplasm of abdomen'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",11.0,0.034252,"Our results show that blinding to intervention or usual care was a challenge, participants felt the intervention was safe and suitable aided by the assistance of a research nurse, yet, found the self-completion questionnaire tools hard to complete.","[{'ForeName': 'Ferhana', 'Initials': 'F', 'LastName': 'Hashem', 'Affiliation': 'Centre for Health Service Studies, University of Kent, Canterbury, Kent, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stephensen', 'Affiliation': 'Physiotherapy Department, East Kent Hospitals University Foundation NHS Trust, Kent and Canterbury Hospital, Canterbury, Kent, United Kingdom.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bates', 'Affiliation': 'Centre for Health Service Studies, University of Kent, Canterbury, Kent, United Kingdom.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Pellatt-Higgins', 'Affiliation': 'Centre for Health Service Studies, University of Kent, Canterbury, Kent, United Kingdom.'}, {'ForeName': 'Ralph Nobby Peter', 'Initials': 'RNP', 'LastName': 'Hobbs', 'Affiliation': 'Maidstone and Tunbridge Wells NHS Trust, Maidstone, Maidstone Hospital, Hermitage Lane, Maidstone, Kent, United Kingdom.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Hopkins', 'Affiliation': 'Maidstone and Tunbridge Wells NHS Trust, Maidstone, Maidstone Hospital, Hermitage Lane, Maidstone, Kent, United Kingdom.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Woodward', 'Affiliation': 'Maidstone and Tunbridge Wells NHS Trust, Maidstone, Maidstone Hospital, Hermitage Lane, Maidstone, Kent, United Kingdom.'}, {'ForeName': 'Charitini', 'Initials': 'C', 'LastName': 'Stavropoulou', 'Affiliation': 'School of Health Sciences, City University, London, Northampton Square, United Kingdom.'}, {'ForeName': 'Ian L', 'Initials': 'IL', 'LastName': 'Swaine', 'Affiliation': 'Centre for Science and Medicine in Sport and Exercise, University of Greenwich, Gillingham, Chatham, United Kingdom.'}, {'ForeName': 'Haythem', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'Maidstone and Tunbridge Wells NHS Trust, Maidstone, Maidstone Hospital, Hermitage Lane, Maidstone, Kent, United Kingdom.'}]",Cancer control : journal of the Moffitt Cancer Center,['10.1177/1073274820950855']
2137,33035741,"Differentiating ""types"" of treatment dropout: Nonstarters in an RCT of prolonged exposure versus sertraline.","Despite effective interventions for posttraumatic stress disorder (PTSD), many patients prematurely drop out. Differentiating ""types"" of dropout at various stages of treatment may improve our ability to predict and prevent attrition. Using data from a doubly randomized preference trial, this study examined patient dropout prior to treatment and compared these ""nonstarters"" with treatment starters and in-treatment dropouts. Patients (N = 200) with chronic PTSD were randomized to ""choice"" (prolonged exposure [PE] or sertraline) or ""no choice"" (re-randomized to PE or sertraline) and received up to 10 weeks of treatment. Overall dropout rate was 33.0% (n = 66). A substantial minority were nonstarters (n = 19; 28.8%). Relative to patients who began treatment, nonstarters reported less severe PTSD symptomatology (p = .03, d = 0.57) and were less likely to have received their preferred treatment (p < .001). These differences remained even when comparing nonstarters to patients that began treatment but eventually dropped out. Differences in beliefs (i.e., perceived credibility) toward one treatment versus the other were also linked to pretreatment dropout. Reasons underlying dropout likely differ during various treatment stages. Better understanding risk factors for types of dropout may inform strategies to boost engagement and retention, ultimately improving patient outcomes.",2020,"Relative to patients who began treatment, nonstarters reported less severe PTSD symptomatology (p = .03, d = 0.57) and were less likely to have received their preferred treatment (p < .001).",['Patients (N\xa0=\xa0200) with chronic PTSD'],"['choice"" (prolonged exposure [PE] or sertraline) or ""no choice"" (re-randomized to PE or sertraline', 'sertraline']","['Overall dropout rate', 'severe PTSD symptomatology']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}]","[{'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]",200.0,0.0323563,"Relative to patients who began treatment, nonstarters reported less severe PTSD symptomatology (p = .03, d = 0.57) and were less likely to have received their preferred treatment (p < .001).","[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Kline', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA. Electronic address: ack63@case.edu.'}, {'ForeName': 'Allison L', 'Initials': 'AL', 'LastName': 'Baier', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA.'}, {'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Klein', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA.'}, {'ForeName': 'Norah C', 'Initials': 'NC', 'LastName': 'Feeny', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Zoellner', 'Affiliation': 'Center for Anxiety and Traumatic Stress, University of Washington, Department of Psychology, Guthrie Hall, Box 351525, Seattle, WA, 98195-1525, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103750']
2138,33035763,Effect of oral health intervention on cognitive decline in community-dwelling older adults: A randomized controlled trial.,"PURPOSE


The incidence of dementia is rapidly increasing worldwide, especially in developed countries. Little is known regarding the effectiveness of dental intervention to prevent dementia or a decline in cognitive functions among community-dwelling older adults, but a few studies have reported a correlation between the lack of regular dental checkups and dementia. For that reason, this study aimed to investigate the effects of oral health intervention on cognitive functions in community-dwelling subjects with a mild cognitive decline via a randomized controlled trial.
PATIENTS AND METHODS


Fifty-five community-dwelling older adults with a Mini-Mental State Examination score of ≥21 to ≤26 who had not visited a dental clinic in the previous year were randomized to an intervention group (n = 28) or a control group (n = 29). The intervention group received monthly oral health intervention by dental hygienists for 8 months while the control group did not. Data on demographics, cognitive function and oral parameters were collected before and after the intervention.
RESULTS


Twenty-five subjects in the intervention group (mean age 77.0 years) and 25 in the control group (mean age 72.8 years) completed the study. Significant improvements were observed in the Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability in the intervention group (P < 0.05). There were also significant interactions between the TMT-A and TMT-B scores, oral diadochokinesis, tongue pressure and chewing ability (P < 0.05).
CONCLUSION


Oral health intervention by dental hygienists may be effective for improving the oral health and executive function of cognitive function assessed via TMT.",2020,"Significant improvements were observed in the Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability in the intervention group (P < 0.05).","['Twenty-five subjects in the intervention group (mean age 77.0 years) and 25 in the control group (mean age 72.8 years) completed the study', 'community-dwelling subjects with a mild cognitive decline via a randomized controlled trial', 'community-dwelling older adults', 'Fifty-five community-dwelling older adults with a Mini-Mental State Examination score of ≥21 to ≤26 who had not visited a dental clinic in the previous year']","['oral health intervention', 'monthly oral health intervention']","['cognitive decline', 'Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability', 'cognitive functions', 'demographics, cognitive function and oral parameters', 'TMT-A and TMT-B scores, oral diadochokinesis, tongue pressure and chewing ability']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0011344', 'cui_str': 'Dental clinic'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0278157', 'cui_str': 'Diadochokinesia'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0566339', 'cui_str': 'Ability to chew'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",55.0,0.0438053,"Significant improvements were observed in the Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability in the intervention group (P < 0.05).","[{'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Matsubara', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549, Japan. Electronic address: m.chiakingyo@gmail.com.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Shirobe', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549, Japan; Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: mashirobe@gmail.com.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Furuya', 'Affiliation': 'Department of Geriatric Dentistry, Showa University School of Dentistry, 2-1-1 Kitasenzoku, Ohta-ku, Tokyo 145-8515, Japan. Electronic address: furuyajunichi@gmail.com.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan; Gerodontology, Department of Oral Health Science, Faculty of Dental Medicine, Hokkaido University, Nishi-7, Kita-13, Kita-ku, Sapporo, 060-8586, Japan. Electronic address: ywata@den.hokudai.ac.jp.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Motokawa', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: kikiki_1004@yahoo.co.jp.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Edahiro', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: aedahiro514@gmail.com.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Ohara', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: yohara@tmig.or.jp.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Awata', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: awata@tmig.or.jp.'}, {'ForeName': 'Hunkyung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: kimhk@tmig.or.jp.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: fujiwayo@tmig.or.jp.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Obuchi', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: obuchipc@tmig.or.jp.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Hirano', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: h-hiro@gd5.so-net.ne.jp.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Minakuchi', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549, Japan. Electronic address: s.minakuchi.gerd@tmd.ac.jp.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104267']
2139,33036063,Patient and caregiver agreement on prognosis estimates for older adults with advanced cancer.,"BACKGROUND


Disagreements between patients and caregivers about treatment benefits, care decisions, and patients' health are associated with increased patient depression as well as increased caregiver anxiety, distress, depression, and burden. Understanding the factors associated with disagreement may inform interventions to improve the aforementioned outcomes.
METHODS


For this analysis, baseline data were obtained from a cluster-randomized geriatric assessment trial that recruited patients aged ≥70 years who had incurable cancer from community oncology practices (University of Rochester Cancer Center 13070; Supriya G. Mohile, principal investigator). Patient and caregiver dyads were asked to estimate the patient's prognosis. Response options were 0 to 6 months, 7 to 12 months, 1 to 2 years, 2 to 5 years, and >5 years. The dependent variable was categorized as exact agreement (reference), patient-reported longer estimate, or caregiver-reported longer estimate. The authors used generalized estimating equations with multinomial distribution to examine the factors associated with patient-caregiver prognostic estimates. Independent variables were selected using the purposeful selection method.
RESULTS


Among 354 dyads (89% of screened patients were enrolled), 26% and 22% of patients and caregivers, respectively, reported a longer estimate. Compared with dyads that were in agreement, patients were more likely to report a longer estimate when they screened positive for polypharmacy (β = 0.81; P = .001), and caregivers reported greater distress (β = 0.12; P = .03). Compared with dyads that were in agreement, caregivers were more likely to report a longer estimate when patients screened positive for polypharmacy (β = 0.82; P = .005) and had lower perceived self-efficacy in interacting with physicians (β = -0.10; P = .008).
CONCLUSIONS


Several patient and caregiver factors were associated with patient-caregiver disagreement about prognostic estimates. Future studies should examine the effects of prognostic disagreement on patient and caregiver outcomes.",2020,"Compared with dyads that were in agreement, caregivers were more likely to report a longer estimate when patients screened positive for polypharmacy (β = 0.82; P = .005) and had lower perceived self-efficacy in interacting with physicians (β = -0.10; P = .008).
","['older adults with advanced cancer', 'patients aged ≥70 years who had incurable cancer from community oncology practices (University of Rochester Cancer Center 13070; Supriya G. Mohile, principal investigator']",[],['self-efficacy'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1521895', 'cui_str': 'Principal investigator'}]",[],"[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.138278,"Compared with dyads that were in agreement, caregivers were more likely to report a longer estimate when patients screened positive for polypharmacy (β = 0.82; P = .005) and had lower perceived self-efficacy in interacting with physicians (β = -0.10; P = .008).
","[{'ForeName': 'Kah Poh', 'Initials': 'KP', 'LastName': 'Loh', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Soto-Perez-de-Celis', 'Affiliation': 'Department of Geriatrics, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Duberstein', 'Affiliation': 'Department of Health Behavior, Society, and Policy, Rutgers School of Public Health, Piscataway, New Jersey.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Epstein', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Sindhuja', 'Initials': 'S', 'LastName': 'Kadambi', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Flannery', 'Affiliation': 'School of Nursing, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Magnuson', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McHugh', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Trevino', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Tuch', 'Affiliation': 'Department of Aged Care, Alfred Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Ramsdale', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Yousefi-Nooraie', 'Affiliation': 'Department of Public Health Sciences, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Sedenquist', 'Affiliation': 'SCOREboard Advisory Group, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Jane Jijun', 'Initials': 'JJ', 'LastName': 'Liu', 'Affiliation': 'Heartland National Cancer Institute Community Oncology Research Program (NCORP), Decatur, Illinois.'}, {'ForeName': 'Nataliya', 'Initials': 'N', 'LastName': 'Melnyk', 'Affiliation': 'Delaware/Christiana Care NCORP, Newark, Delaware.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Geer', 'Affiliation': 'Metro-Minnesota NCORP, St Paul, Minnesota.'}, {'ForeName': 'Supriya G', 'Initials': 'SG', 'LastName': 'Mohile', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}]",Cancer,['10.1002/cncr.33259']
2140,33036155,"Effects of the Daily Consumption of Stevia on Glucose Homeostasis, Body Weight, and Energy Intake: A Randomised Open-Label 12-Week Trial in Healthy Adults.","Stevia is a non-nutritive sweetener, providing sweet taste with no calories. This randomised, controlled, open-label 2-parallel arm trial examined the effects of daily stevia consumption on glycaemia in healthy adults. Secondary endpoints included body weight (BW) and energy intake (EI). Healthy participants ( n  = 28; aged 25 ± 5y, body mass index 21.2 ± 1.7 kg/m 2 ) were randomised into either the stevia group ( n  = 14)-required to consume a stevia extract daily-or to the control group ( n  = 14). At weeks 0 and 12, the glucose and insulin responses to an oral glucose tolerance test were measured; BW and EI were assessed at weeks 0, 6, and 12. There was no significant difference in the glucose or insulin responses. There was a significant main effect of group on BW change (F(1,26) = 5.56,  p  = 0.026), as the stevia group maintained their weight as opposed to the control group (mean weight change at week 12: -0.22 kg, 95%CI [-0.96, 0.51] stevia group, +0.89 kg, 95%CI [0.16, 1.63] control group). The energy intake was significantly decreased between week 0 and 12 in the stevia group ( p  = 0.003), however no change was found in the control group ( p  = 0.973). Although not placebo-controlled, these results suggest that daily stevia consumption does not affect glycaemia in healthy individuals, but could aid in weight maintenance and the moderation of EI.",2020,"The energy intake was significantly decreased between week 0 and 12 in the stevia group ( p  = 0.003), however no change was found in the control group ( p  = 0.973).","['Healthy Adults', 'healthy individuals', 'healthy adults', 'Healthy participants ( n  = 28; aged 25 ± 5y, body mass index 21.2 ± 1.7 kg/m 2 ']","['stevia group ( n  = 14)-required to consume a stevia extract daily-or to the control group', 'placebo', 'daily stevia consumption']","['body weight (BW) and energy intake (EI', 'energy intake', 'Glucose Homeostasis, Body Weight, and Energy Intake', 'glucose or insulin responses', 'glucose and insulin responses to an oral glucose tolerance test']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517512', 'cui_str': '1.7'}]","[{'cui': 'C0075246', 'cui_str': 'stevioside'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]",28.0,0.0416548,"The energy intake was significantly decreased between week 0 and 12 in the stevia group ( p  = 0.003), however no change was found in the control group ( p  = 0.973).","[{'ForeName': 'Nikoleta S', 'Initials': 'NS', 'LastName': 'Stamataki', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Crooks', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}, {'ForeName': 'Abubaker', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'McLaughlin', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}]",Nutrients,['10.3390/nu12103049']
2141,33044203,Effects of insole on the less affected side during execution of treadmill walking training on gait ability in chronic stroke patients: A preliminary study.,"BACKGROUND


People who have had hemiplegic stoke generally move more weight to the unaffected side than the affected side, resulting in asymmetrical posture and decreased ability in walking.
OBJECTIVES


This study sought to investigate the effect of inducing a weight shift to the affected side by raising the shoe height of the less affected side using an insole during the execution of treadmill training on gait ability in people with chronic stroke.
METHODS


The subjects were randomly assigned into two groups: insole on less affected side for execution of treadmill walking training (ILTW) group and normal treadmill training (NTW) group. The treadmill training was conducted for 30 minutes per session, 5 times a week, for 4 weeks. A gait analyzer based on body center, Functional Gait Assessment (FGA), Figure-of-Eight Walk Test (F8WT), and 6 min Walk Test (6 MWT), was measured before first intervention and after twentieth treadmill training intervention (Trial registration number is KCT0003830).
RESULTS


The results revealed statistically significant differences between the two groups in the Speed, Cadence, Stride Length/Height, Stride Length, Double Support Duration, Single Support Duration, FGA, F8WT, and 6 MWT of the gait test. In the ILTW group, statistically significant improvements were observed in the Speed, Stride Length/Height, Stride Length, Stance Phase Duration, Swing Phase Duration, Double Support Duration, Single Support Duration, FGA, F8WT, and 6 MWT after execution of training, while in the NTW group, statistically significant improvements were observed only in Speed, Cadence, FGA, F8WT, and 6 MWT.
CONCLUSIONS


ILTW, more than NTW, may improve walking ability in people with chronic stroke as it increases the weight-support ratio by adjusting the shoe height of the unaffected side using an insole.",2020,"In the ILTW group, statistically significant improvements were observed in the Speed, Stride Length/Height, Stride Length, Stance Phase Duration, Swing Phase Duration, Double Support Duration, Single Support Duration, FGA, F8WT, and 6 MWT after execution of training, while in the NTW group, statistically significant improvements were observed only in Speed, Cadence, FGA, F8WT, and 6 MWT.
","['chronic stroke patients', 'People who have had hemiplegic stoke', 'people with chronic stroke']","['side for execution of treadmill walking training (ILTW) group and normal treadmill training (NTW', 'treadmill walking training', 'treadmill training']","['Speed, Stride Length/Height, Stride Length, Stance Phase Duration, Swing Phase Duration, Double Support Duration, Single Support Duration, FGA, F8WT, and 6\u200aMWT after execution of training', 'weight-support ratio', 'body center, Functional Gait Assessment (FGA), Figure-of-Eight Walk Test (F8WT), and 6 min Walk Test (6\u200aMWT', 'Speed, Cadence, FGA, F8WT, and 6\u200aMWT', 'gait ability', 'walking ability', 'Speed, Cadence, Stride Length/Height, Stride Length, Double Support Duration, Single Support Duration, FGA, F8WT, and 6\u200aMWT of the gait test']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0322436,"In the ILTW group, statistically significant improvements were observed in the Speed, Stride Length/Height, Stride Length, Stance Phase Duration, Swing Phase Duration, Double Support Duration, Single Support Duration, FGA, F8WT, and 6 MWT after execution of training, while in the NTW group, statistically significant improvements were observed only in Speed, Cadence, FGA, F8WT, and 6 MWT.
","[{'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'An', 'Affiliation': 'Department of Physical Therapy, Raon Hue Hospital, Sinwol-ro, Yangcheon-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Youngkeun', 'Initials': 'Y', 'LastName': 'Woo', 'Affiliation': 'Department of Physical Therapy, College of Medical Sciences, Jeonju University, Cheonjam-ro, Wansan-gu, Jeonju, Republic of Korea.'}, {'ForeName': 'Kyeunam', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, College of Medical Sciences, Jeonju University, Cheonjam-ro, Wansan-gu, Jeonju, Republic of Korea.'}, {'ForeName': 'Sujin', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, College of Medical Sciences, Jeonju University, Cheonjam-ro, Wansan-gu, Jeonju, Republic of Korea.'}]",Restorative neurology and neuroscience,['10.3233/RNN-201040']
2142,33044213,The effects of bright light treatment via ear canals on quality of sleep and depressive mood among overworked employees: A randomized-controlled clinical trial.,"BACKGROUND


Many overworked employees need tools to improve their depressive mood or sleep disorder. In Finland, a new device of bright light therapy was developed.
OBJECTIVE


Our objective was to evaluate the effect of bright light treatment via ear canals on improving the depressive mood and sleep disorder.
METHODS


We conducted a randomized, controlled, crossover designed, open-label trial. We examined 27 participants aged 23-52 years, assigned to either Early treatment or Later treatment groups. The Early treatment group used the device on weekdays for the first 4 weeks, followed by a 4-week observation period. The Later treatment group had an observation period for the first 4 weeks, followed by device treatment for the subsequent 4 weeks. Every Friday, the participants were asked to answer questionnaires: A Self-rating Depression Scale (SDS), an Athens Insomnia Scale (AIS), and a Profile of Mood States (POMS) Brief Form.
RESULTS


While no significant effect was found on the SDS following treatment (p = 0.16), the AIS showed a significant improvement (p = 0.004), and the scores for the Depression (D) and Vigor (V) of POMs decreased significantly (p = 0.045, p = 0.006, respectively).
CONCLUSIONS


Bright light treatment via ear canals may improve sleep quality and depressive mood.",2020,"While no significant effect was found on the SDS following treatment (p = 0.16), the AIS showed a significant improvement (p = 0.004), and the scores for the Depression (D) and Vigor (V) of POMs decreased significantly (p = 0.045, p = 0.006, respectively).
","['27 participants aged 23-52 years', 'among overworked employees']",['bright light treatment via ear canals'],"['scores for the Depression (D) and Vigor (V) of POMs', 'depressive mood and sleep disorder', 'quality of sleep and depressive mood', 'sleep quality and depressive mood', 'A Self-rating Depression Scale (SDS), an Athens Insomnia Scale (AIS), and a Profile of Mood States (POMS']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2937246', 'cui_str': 'Overwork'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013444', 'cui_str': 'External auditory canal structure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]",27.0,0.069277,"While no significant effect was found on the SDS following treatment (p = 0.16), the AIS showed a significant improvement (p = 0.004), and the scores for the Depression (D) and Vigor (V) of POMs decreased significantly (p = 0.045, p = 0.006, respectively).
","[{'ForeName': 'Tetsu', 'Initials': 'T', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Basic Nursing and Health Science, Ehime University Graduate School of Medicine, Toon, Ehime, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Tanigawa', 'Affiliation': 'Department of Public Health, Juntendo University Graduate School of Medicine, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Koutatsu', 'Initials': 'K', 'LastName': 'Maruyama', 'Affiliation': 'Special Course of Food and Health Science, Department of Bioscience Graduate School of Agriculture, Ehime University, Matsuyama, Ehime, Japan.'}, {'ForeName': 'Kanehisa', 'Initials': 'K', 'LastName': 'Morimoto', 'Affiliation': 'Human Factors Research Institute, Japan Foundation for Environmental Health Sciences, Minato-ku, Tokyo, Japan.'}]","Work (Reading, Mass.)",['10.3233/WOR-203282']
2143,33044249,Allogeneic Platelet-Rich Plasma Versus Corticosteroid Injection for the Treatment of Rotator Cuff Disease: A Randomized Controlled Trial.,"BACKGROUND


The use of platelet-rich plasma (PRP) for the treatment of rotator cuff disease is still controversial. The purpose of the present study was to investigate the safety and efficacy of a fully characterized allogeneic pure PRP injection into the subacromial space of patients with rotator cuff disease in comparison with corticosteroid injection.
METHODS


A 2-group, parallel, assessor-blinded, randomized controlled trial was conducted. A total of 60 patients with clinically and structurally diagnosed rotator cuff disease were randomly assigned to receive a subacromial injection of either 4 mL of allogeneic pure PRP or a 4-mL mixture of 1 mL of 40-mg/mL triamcinolone acetonide and 3 mL of 2% lidocaine under ultrasonographic guidance. The primary outcomes were safety and the Constant score at 1 month. The secondary outcomes were pain, range of motion, muscle strength, functional scores, and overall satisfaction and function.
RESULTS


There were no treatment-related adverse events. The Constant score at 1 month did not significantly differ between the PRP and corticosteroid groups. At 6 months, the DASH (Disabilities of the Arm, Shoulder and Hand) score, overall function, and external rotation were significantly better in the PRP group than in the corticosteroid group, and the other clinical outcomes did not show significant differences. All pain measurements, the strength of the supraspinatus and infraspinatus, and 5 functional scores also improved slowly and steadily after injection, becoming significantly better at 6 months compared with those before the injection, whereas those in the corticosteroid group responded promptly but did not further improve.
CONCLUSIONS


Allogeneic PRP injections for the treatment of rotator cuff disease are safe but are not definitely superior to corticosteroid injections with respect to pain relief and functional improvement during 6 months. The DASH score, overall function, and external rotation were significantly better in the PRP group than in the steroid group at 6 months. Generally, PRP slowly but steadily reduced pain and improved function of the shoulder until 6 months, whereas corticosteroid did not.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"The DASH score, overall function, and external rotation were significantly better in the PRP group than in the steroid group at 6 months.","['60 patients with clinically and structurally diagnosed rotator cuff disease', 'patients with rotator cuff disease in comparison with corticosteroid injection', 'Rotator Cuff Disease']","['platelet-rich plasma (PRP', 'PRP', 'subacromial injection of either 4 mL of allogeneic pure PRP or a 4-mL mixture of 1 mL of 40-mg/mL triamcinolone acetonide and 3 mL of 2% lidocaine', 'Allogeneic PRP injections', 'Allogeneic Platelet-Rich Plasma Versus Corticosteroid Injection', 'fully characterized allogeneic pure PRP injection']","['pain relief and functional improvement', 'DASH score, overall function, and external rotation', 'safety and efficacy', 'DASH (Disabilities of the Arm, Shoulder and Hand) score, overall function, and external rotation', 'adverse events', 'pain, range of motion, muscle strength, functional scores, and overall satisfaction and function', 'Constant score', 'safety and the Constant score', 'pain and improved function', 'All pain measurements, the strength of the supraspinatus and infraspinatus, and 5 functional scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0584869', 'cui_str': 'Supraspinatus muscle structure'}, {'cui': 'C0584882', 'cui_str': 'Infraspinatus muscle structure'}]",60.0,0.109834,"The DASH score, overall function, and external rotation were significantly better in the PRP group than in the steroid group at 6 months.","[{'ForeName': 'Chris Hyunchul', 'Initials': 'CH', 'LastName': 'Jo', 'Affiliation': 'Departments of Orthopedic Surgery (C.H.J., S.Y.L., and K.S.Y.), Biostatistics (S.O.), and Laboratory Medicine (S.S.), SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Yeon', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Departments of Orthopedic Surgery (C.H.J., S.Y.L., and K.S.Y.), Biostatistics (S.O.), and Laboratory Medicine (S.S.), SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kang Sup', 'Initials': 'KS', 'LastName': 'Yoon', 'Affiliation': 'Departments of Orthopedic Surgery (C.H.J., S.Y.L., and K.S.Y.), Biostatistics (S.O.), and Laboratory Medicine (S.S.), SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sohee', 'Initials': 'S', 'LastName': 'Oh', 'Affiliation': 'Departments of Orthopedic Surgery (C.H.J., S.Y.L., and K.S.Y.), Biostatistics (S.O.), and Laboratory Medicine (S.S.), SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Shin', 'Affiliation': 'Departments of Orthopedic Surgery (C.H.J., S.Y.L., and K.S.Y.), Biostatistics (S.O.), and Laboratory Medicine (S.S.), SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01411']
2144,33044283,Effect of Driving Pressure Change During Extracorporeal Membrane Oxygenation in Adults With Acute Respiratory Distress Syndrome: A Randomized Crossover Physiologic Study.,"OBJECTIVES


Venovenous extracorporeal membrane oxygenation is an effective intervention to improve gas exchange in patients with severe acute respiratory distress syndrome. However, the mortality of patients with severe acute respiratory distress syndrome supported with venovenous extracorporeal membrane oxygenation remains high, and this may be due in part to a lack of standardized mechanical ventilation strategies aimed at further minimizing ventilator-induced lung injury. We tested whether a continuous positive airway pressure ventilation strategy mitigates ventilator-induced lung injury in patients with severe acute respiratory distress syndrome on venovenous extracorporeal membrane oxygenation, compared with current ventilation practice that employs tidal ventilation with limited driving pressure. We used plasma biomarkers as a surrogate outcome for ventilator-induced lung injury.
DESIGN


Randomized crossover physiologic study.
SETTING


Single-center ICU.
PATIENTS


Ten patients with severe acute respiratory distress syndrome supported on venovenous extracorporeal membrane oxygenation.
INTERVENTIONS


The study included four phases. After receiving pressure-controlled ventilation with driving pressure of 10 cm H2O for 1 hour (phase 1), patients were randomly assigned to receive first either pressure-controlled ventilation 20 cm H2O for 2 hours (phase 2) or continuous positive airway pressure for 2 hours (phase 3), and then crossover to the other phase for 2 hours; during phase 4 ventilation settings returned to baseline (pressure-controlled ventilation 10 cm H2O) for 4 hours.
MEASUREMENTS AND MAIN RESULTS


There was a linear relationship between the change in driving pressure and the plasma concentration of interleukin-6, soluble receptor for advanced glycation end products, interleukin-1ra, tumor necrosis factor alpha, surfactant protein D, and interleukin-10.
CONCLUSIONS


Ventilator-induced lung injury may occur in acute respiratory distress syndrome patients on venovenous extracorporeal membrane oxygenation despite the delivery of volume- and pressure-limited mechanical ventilation. Reducing driving pressure to zero may provide more protective mechanical ventilation in acute respiratory distress syndrome patients supported with venovenous extracorporeal membrane oxygenation. However, the risks versus benefits of such an approach need to be confirmed in studies that are designed to test patient centered outcomes.",2020,Reducing driving pressure to zero may provide more protective mechanical ventilation in acute respiratory distress syndrome patients supported with venovenous extracorporeal membrane oxygenation.,"['Adults With Acute Respiratory Distress Syndrome', 'Ten patients with severe acute respiratory distress syndrome', 'acute respiratory distress syndrome patients', 'patients with severe acute respiratory distress syndrome']","['Venovenous extracorporeal membrane oxygenation', 'continuous positive airway pressure ventilation strategy mitigates ventilator-induced lung injury', 'venovenous extracorporeal membrane oxygenation', 'Extracorporeal Membrane Oxygenation', 'current ventilation practice that employs tidal ventilation with limited driving pressure', 'Driving Pressure Change', 'pressure-controlled ventilation 20 cm H2O for 2 hours (phase 2) or continuous positive airway pressure']","['driving pressure and the plasma concentration of interleukin-6, soluble receptor for advanced glycation end products, interleukin-1ra, tumor necrosis factor alpha, surfactant protein D, and interleukin-10']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C5192099', 'cui_str': 'Venovenous extracorporeal membrane oxygenation'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C2350350', 'cui_str': 'Lung Injury, Ventilator-Induced'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0563547', 'cui_str': 'Pressure change'}, {'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}]","[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0101725', 'cui_str': 'Receptor for Advanced Glycation Endproducts'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0084692', 'cui_str': 'Surfactant Protein D'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",10.0,0.145177,Reducing driving pressure to zero may provide more protective mechanical ventilation in acute respiratory distress syndrome patients supported with venovenous extracorporeal membrane oxygenation.,"[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Del Sorbo', 'Affiliation': ''}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Goffi', 'Affiliation': 'Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tomlinson', 'Affiliation': 'Institute for Health Policy, Management, and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Pettenuzzo', 'Affiliation': 'Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Facchin', 'Affiliation': 'Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Vendramin', 'Affiliation': 'Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ewan C', 'Initials': 'EC', 'LastName': 'Goligher', 'Affiliation': 'Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Cypel', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Arthur S', 'Initials': 'AS', 'LastName': 'Slutsky', 'Affiliation': 'Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Shaf', 'Initials': 'S', 'LastName': 'Keshavjee', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Niall D', 'Initials': 'ND', 'LastName': 'Ferguson', 'Affiliation': 'Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'Fan', 'Affiliation': 'Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004637']
2145,33044366,Effects of Nonperiodized and Linear Periodized Combined Training on Health-Related Physical Fitness in Adults With Obesity: A Randomized Controlled Trial.,"Streb, AR, Passos da Silva, R, Leonel, LdS, Possamai, LT, Gerage da Silva, AM, Turnes, T, and Del Duca, GF. Effects of nonperiodized and linear periodized combined training on health-related physical fitness in adults with obesity: a randomized controlled trial. J Strength Cond Res XX(X): 000-000, 2020-The aim of this randomized controlled trial study was to compare the effects of 16 weeks of linear periodized and nonperiodized combined training (CT) on cardiorespiratory fitness, muscle strength, and body composition indicators of adults with obesity. Thirty-four obese adults of both sexes (36.6 ± 4.4 years; body mass index, 32.9 ± 2.7 kg·m) were divided into nonperiodized (NG; n = 8), linear periodized (PG; n = 11), and control (CG; n = 15) groups. The NG and PG groups performed 3 weekly sessions of CT over 16 weeks in different ways. Anthropometric measures, maximal strength for leg press and barbell bench press, maximal oxygen uptake (V[Combining Dot Above]O2max), and ventilatory thresholds were determined before and after the intervention. The generalized estimation equation was used, adopting the level of significance for the interaction of 0.10, and 0.05 for the isolated effect of time or group or both. Significant and similar increases were observed in the 1-repetition maximum test for bench press (NG: 48.8 ± 5.7 to 55.0 ± 6.1 kg; PG: 48.7 ± 5.7 to 53.8 ± 5.9 kg; p = 0.001) and leg press (NG: 235.2 ± 18.7 to 268.3 ± 19.7 kg; PG: 223.1 ± 25.3 to 253.3 ± 23.1 kg; p = 0.05) in trained groups. Relative V[Combining Dot Above]O2max improved only in PG (27.8 ± 1.3 to 32.0 ± 1.4 mL·kg·min; p = 0.05), whereas ventilatory thresholds improved in NG and CG (p = 0.004 and p = 0.06). There was an increase in body mass in CG (97.6 ± 3.4 to 99.1 ± 2.9 kg) and NG (92.5 ± 5.4 to 93.5 ± 5.4 kg; p = 0.05). Combined training improved maximal upper- and lower-body strength regardless of periodization. However, for improvements in V[Combining Dot Above]O2max, linear periodization may be superior than nonperiodization in obese adults.",2020,Significant and similar increases were observed in the 1-repetition maximum test for bench press (NG: 48.8 ± 5.7 to 55.0 ± 6.1 kg; PG: 48.7 ± 5.7 to 53.8 ± 5.9 kg; p = 0.001) and leg press (NG: 235.2 ± 18.7 to 268.3 ± 19.7 kg; PG: 223.1 ± 25.3 to 253.3 ± 23.1 kg; p = 0.05) in trained groups.,"['adults with obesity', 'Thirty-four obese adults of both sexes (36.6 ± 4.4 years; body mass index, 32.9 ± 2.7 kg·m', 'Adults With Obesity', 'obese adults']","['V[Combining', 'linear periodized and nonperiodized combined training (CT', 'Nonperiodized and Linear Periodized Combined Training', 'nonperiodized and linear periodized combined training', 'J Strength Cond Res XX(X', 'CT', 'Relative V[Combining']","['Dot Above]O2max', 'cardiorespiratory fitness, muscle strength, and body composition indicators', 'Dot Above]O2max), and ventilatory thresholds', 'Streb, AR, Passos da Silva, R, Leonel, LdS, Possamai, LT, Gerage da Silva, AM, Turnes, T, and Del Duca, GF', 'health-related physical fitness', 'ventilatory thresholds', 'body mass', 'maximal upper- and lower-body strength regardless of periodization', 'Anthropometric measures, maximal strength for leg press and barbell bench press, maximal oxygen uptake ', 'Health-Related Physical Fitness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517635', 'cui_str': '2.7'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",34.0,0.0663164,Significant and similar increases were observed in the 1-repetition maximum test for bench press (NG: 48.8 ± 5.7 to 55.0 ± 6.1 kg; PG: 48.7 ± 5.7 to 53.8 ± 5.9 kg; p = 0.001) and leg press (NG: 235.2 ± 18.7 to 268.3 ± 19.7 kg; PG: 223.1 ± 25.3 to 253.3 ± 23.1 kg; p = 0.05) in trained groups.,"[{'ForeName': 'Anne Ribeiro', 'Initials': 'AR', 'LastName': 'Streb', 'Affiliation': 'Departament of Physical Education, Physical Exercise Study Group in Chronic Non-communicable Diseases, Center of Sports-CDS, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Passos da Silva', 'Affiliation': 'Departament of Physical Education, Physical Exercise Study Group in Chronic Non-communicable Diseases, Center of Sports-CDS, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Larissa Dos Santos', 'Initials': 'LDS', 'LastName': 'Leonel', 'Affiliation': 'Departament of Physical Education, Physical Exercise Study Group in Chronic Non-communicable Diseases, Center of Sports-CDS, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Leonardo Trevisol', 'Initials': 'LT', 'LastName': 'Possamai', 'Affiliation': 'Departament of Physical Education, Physical Effort Laboratory, Center of Sports-CDS, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Aline Mendes', 'Initials': 'AM', 'LastName': 'Gerage da Silva', 'Affiliation': 'Departament of Physical Education, Physical Exercise Study Group in Chronic Non-communicable Diseases, Center of Sports-CDS, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Turnes', 'Affiliation': 'Departament of Physical Education, Physical Effort Laboratory, Center of Sports-CDS, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Giovani Firpo', 'Initials': 'GF', 'LastName': 'Del Duca', 'Affiliation': 'Departament of Physical Education, Physical Exercise Study Group in Chronic Non-communicable Diseases, Center of Sports-CDS, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003859']
2146,33044367,"Effects of Curcumin and Fenugreek Soluble Fiber on the Physical Working Capacity at the Fatigue Threshold, Peak Oxygen Consumption, and Time to Exhaustion.","Herrick, LP, Goh, J, Menke, W, Campbell, MS, Fleenor, BS, Abel, MG, and Bergstrom, HC. Effects of curcumin and fenugreek soluble fiber on the physical working capacity at the fatigue threshold, peak oxygen consumption, and time to exhaustion. J Strength Cond Res XX(X): 000-000, 2020-The purpose of this study was to examine the effects of curcumin in combination with fenugreek soluble fiber (CUR + FEN) or fenugreek soluble fiber alone (FEN) on the neuromuscular fatigue threshold (PWCFT), peak oxygen consumption (V[Combining Dot Above]o2peak), and time to exhaustion (Tlim) on a graded exercise test (GXT), in untrained subjects. The PWCFT estimates the highest power output that can be maintained without evidence of neuromuscular fatigue. Forty-seven untrained, college-aged subjects were randomly assigned to one of 3 supplementation groups; placebo (PLA, n = 15), CUR + FEN (500 mg·d, n = 18), or FEN (300 mg·d, n = 14). The subjects completed a maximal GXT on a cycle ergometer to determine the PWCFT, V[Combining Dot Above]o2peak, and Tlim before (PRE) and after (POST) 28 days of daily supplementation. Surface electromyographic signals were recorded from a bipolar electrode arrangement on the vastus lateralis of the right leg during each test. Separate one-way analysis of covariances were used to determine if there were between-group differences for adjusted POST-PWCFT, POST-V[Combining Dot Above]o2peak, and POST-Tlim values, covaried for the respective PRE-test scores. The adjusted POST-PWCFT for the CUR + FEN group (mean ± SD: 196 ± 58 W) was greater (p = 0.016) than the PLA group (168 ± 49 W) but the FEN group (185 ± 32 W) was not different from the CUR + FEN or PLA groups (p > 0.05). There were no differences for adjusted POST-V[Combining Dot Above]o2peak (p = 0.612) or POST-Tlim (p = 0.508) among the groups. These findings suggested curcumin combined with fenugreek soluble fiber might delay neuromuscular fatigue.",2020,There were no differences for adjusted POST-,"['Forty-seven untrained, college-aged subjects', 'untrained subjects']","['V[Combining', 'placebo (PLA, n = 15), CUR + FEN', 'curcumin in combination with fenugreek soluble fiber (CUR + FEN) or fenugreek soluble fiber alone (FEN', 'J Strength Cond Res XX(X', 'maximal GXT', 'Curcumin and Fenugreek Soluble Fiber', 'FEN', 'graded exercise test (GXT', 'curcumin and fenugreek soluble fiber']","['Surface electromyographic signals', 'adjusted POST', 'Physical Working Capacity at the Fatigue Threshold, Peak Oxygen Consumption, and Time to Exhaustion', 'Herrick, LP, Goh, J, Menke, W, Campbell, MS, Fleenor, BS, Abel, MG, and Bergstrom, HC', 'neuromuscular fatigue threshold (PWCFT), peak oxygen consumption ', 'Dot Above]o2peak), and time to exhaustion (Tlim', 'physical working capacity at the fatigue threshold, peak oxygen consumption, and time to exhaustion', 'Dot Above]o2peak, and Tlim before (PRE']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0557806', 'cui_str': 'College'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0060207', 'cui_str': 'Fenugreek'}, {'cui': 'C3661727', 'cui_str': 'Soluble fiber'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0022716', 'cui_str': 'Menkes kinky-hair syndrome'}, {'cui': 'C0234116', 'cui_str': 'Neuromuscular fatigue'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",,0.0301262,There were no differences for adjusted POST-,"[{'ForeName': 'Lauren P', 'Initials': 'LP', 'LastName': 'Herrick', 'Affiliation': 'Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Jensen', 'Initials': 'J', 'LastName': 'Goh', 'Affiliation': 'Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Menke', 'Affiliation': 'Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Marilyn S', 'Initials': 'MS', 'LastName': 'Campbell', 'Affiliation': 'Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Fleenor', 'Affiliation': 'Ball State University, School of Kinesiology, Muncie, Indiana.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Abel', 'Affiliation': 'Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Haley C', 'Initials': 'HC', 'LastName': 'Bergstrom', 'Affiliation': 'Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, Kentucky.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003852']
2147,33044376,Why Irrigate for the Same Contamination Rate: Wound Contamination in Pediatric Spinal Surgery Using Betadine Versus Saline.,"BACKGROUND


The risk of surgical site infection in pediatric posterior spine fusion (PSF) is up to 4.3% in idiopathic populations and 24% in patients with neuromuscular disease. Twenty-three percent of pediatric PSF tissue cultures are positive before closure, with a higher rate in neuromuscular patients. Our primary aim was to evaluate the feasibility of a complete randomized controlled trial to study the efficacy of surgical site irrigation with povidone-iodine (PVP-I) compared with sterile saline (SS) to reduce the bacterial contamination rate before closure in children undergoing PSF.
METHODS


One hundred seventy-five subjects undergoing PSF were enrolled in a multicenter, single-blind, pilot randomized controlled trial. We recruited patients at low-risk (LR) and high-risk (HR) for infection 3:1, respectively. Before closure, a wound culture was collected. Nonviable tissues were debrided and the wound was soaked with 0.35% PVP-I or SS for 3 minutes. The wound was then irrigated with 2 L of saline and a second sample was collected.
RESULTS


One hundred fifty-three subjects completed the protocol. Seventy-seven subjects were allocated to PVP-I (18 HR, 59 LR) and 76 to SS (19 HR, 57 LR). Cultures were positive in 18% (14/77) of PVP-I samples (2 HR, 12 LR) and in 17% (13/76) of SS samples (3 HR, 10 LR) preirrigation and in 16% (12/77) of PVP-I samples (5 HR, 7 LR) and in 18% (14/76) of SS samples (4 HR, 10 LR) postirrigation. Eight percent (3/37) HR subjects (1 PVP-I, 2 SS) experienced infection at 30 days postoperative. No LR subjects experienced infection.
CONCLUSIONS


Positive cultures were similar across treatment and risk groups. The bacterial contamination of wounds before closure remains high regardless of irrigation type. A complete randomized controlled trial would be challenging to adequately power given the similarity of tissue positivity across groups.
LEVEL OF EVIDENCE


Level II-pilot randomized controlled trial.",2020,Cultures were positive in 18% (14/77) of PVP-,"['Seventy-seven subjects', 'patients at low-risk (LR) and high-risk (HR) for infection 3:1, respectively', 'children undergoing PSF', 'One hundred fifty-three subjects completed the protocol', 'pediatric posterior spine fusion (PSF', 'One hundred seventy-five subjects undergoing PSF', 'patients with neuromuscular disease']","['sterile saline (SS', 'Betadine Versus Saline', 'surgical site irrigation with povidone-iodine (PVP-I']",['bacterial contamination rate'],"[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0027868', 'cui_str': 'Myoneural disorder'}]","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0699524', 'cui_str': 'Betadine'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}]",[],175.0,0.189586,Cultures were positive in 18% (14/77) of PVP-,"[{'ForeName': 'Lara L', 'Initials': 'LL', 'LastName': 'Cohen', 'Affiliation': ""Department of Orthopaedic Surgery, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Schwend', 'Affiliation': ""Department of Orthopaedic Surgery, Children's Mercy Hospital and University of Missouri, Kansas City, MO.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Flynn', 'Affiliation': ""Department of Orthopaedic Surgery, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Hedequist', 'Affiliation': ""Department of Orthopaedic Surgery, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Lawrence I', 'Initials': 'LI', 'LastName': 'Karlin', 'Affiliation': ""Department of Orthopaedic Surgery, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Emans', 'Affiliation': ""Department of Orthopaedic Surgery, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Snyder', 'Affiliation': ""Department of Orthopaedic Surgery, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Hresko', 'Affiliation': ""Department of Orthopaedic Surgery, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Anderson', 'Affiliation': ""Department of Orthopaedic Surgery, Children's Mercy Hospital and University of Missouri, Kansas City, MO.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Leamon', 'Affiliation': ""Department of Orthopaedic Surgery, Children's Mercy Hospital and University of Missouri, Kansas City, MO.""}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Talwar', 'Affiliation': ""Department of Orthopaedic Surgery, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Glotzbecker', 'Affiliation': ""Department of Orthopaedic Surgery, Boston Children's Hospital, Boston, MA.""}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001620']
2148,33044394,Safety and efficacy of an equimolar mixture of oxygen and nitrous oxide (EMONO): a randomized controlled trial in patients with peripheral neuropathic pain.,"Nitrous oxide (N2O) is an odorless and colorless gas routinely used as an adjuvant of anesthesia and for short duration analgesia in various clinical settings mostly in the form of a N2O/O2 50%-50% equimolar mixture (EMONO). Experimental studies have suggested that EMONO could also induce long lasting analgesic effects related to the blockade of NMDA receptors. We designed the first international multicenter proof of concept randomized, placebo-controlled study to assess the efficacy and safety of a one hour administration of EMONO or placebo (medical air) on three consecutive days up to one month after the last administration in patients with chronic peripheral neuropathic pain. A total of 240 patients were recruited in 22 centers in France and Germany and randomly assigned to one study group (120 per group). Average pain intensity (primary outcome), neuropathic pain characteristics (NPSI), patient global impression of change (PGIC), anxiety, depression and quality of life were systematically assessed before and after treatment. The changes in average pain intensity between baseline and seven days after the last administration were not significantly different between the two groups. However, evoked pain intensity (predefined secondary endpoint) and PGIC (exploratory endpoint), were significantly improved in the EMONO group and these effects were maintained up to four weeks after the last treatment administration. Mostly transient side effects were reported during the treatment administration. These encouraging results provide a basis for further investigation of the long term analgesic effects of EMONO in neuropathic pain patients.",2020,The changes in average pain intensity between baseline and seven days after the last administration were not significantly different between the two groups.,"['neuropathic pain patients', 'patients with peripheral neuropathic pain', 'patients with chronic peripheral neuropathic pain', '240 patients were recruited in 22 centers in France and Germany and randomly assigned to one study group (120 per group']","['Nitrous oxide (N2O', 'placebo', 'EMONO or placebo (medical air', 'equimolar mixture of oxygen and nitrous oxide (EMONO']","['evoked pain intensity', 'Safety and efficacy', 'efficacy and safety', 'Average pain intensity (primary outcome), neuropathic pain characteristics (NPSI), patient global impression of change (PGIC), anxiety, depression and quality of life', 'average pain intensity']","[{'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458960', 'cui_str': 'Peripheral neuropathic pain'}, {'cui': 'C4546313', 'cui_str': 'Chronic peripheral neuropathic pain'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3536832', 'cui_str': 'Air'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",240.0,0.207905,The changes in average pain intensity between baseline and seven days after the last administration were not significantly different between the two groups.,"[{'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Bouhassira', 'Affiliation': 'nserm U987, APHP, CHU Ambroise Paré, UVSQ, Paris-Saclay, 92100 Boulogne-Billancourt, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Perrot', 'Affiliation': 'CETD, CHU Cochin, APHP, Paris-Descartes University, Inserm U987, Paris, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Riant', 'Affiliation': 'CETD M Bensignor.'}, {'ForeName': 'Gaelle', 'Initials': 'G', 'LastName': 'Martiné-Fabre', 'Affiliation': 'Centre de la douleur chronique, CHU de Limoges, 87000 Limoges, France.'}, {'ForeName': 'Gisèle', 'Initials': 'G', 'LastName': 'Pickering', 'Affiliation': 'Clinical Research Center / CIC Inserm 1405, University Hospital, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Maindet', 'Affiliation': 'Centre de la douleur, Pôle Anesthésie Réanimation, CHU Grenoble-Alpes, 38000 Grenoble, France.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Attal', 'Affiliation': 'nserm U987, APHP, CHU Ambroise Paré, UVSQ, Paris-Saclay, 92100 Boulogne-Billancourt, France.'}, {'ForeName': 'Stéphanie Ranque', 'Initials': 'SR', 'LastName': 'Garnier', 'Affiliation': 'Aix-Marseille Université, CNRS, Ecole Centrale Marseille, UMR 7249, Institut Fresnel, Marseille, France.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Nguyen', 'Affiliation': 'Centre de la douleur, Clinique Bretéché, Groupe ELSAN, 44000 Nantes, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Kuhn', 'Affiliation': 'Service Interdisciplinaire Douleur, Soins Palliatifs et de Support, Médecine intégrative, Hôpital Georges et René-Laennec, CHU de Nantes, 44093, Nantes cedex 01, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Viel', 'Affiliation': 'CETD, CHU Nîmes, Faculté de médecine Montpellier-Nîmes, 30029 Nîmes, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kieffert', 'Affiliation': 'Service Douleur, Hôpital Mercy, Centre Hospitalier Régional Metz-Thionville, 57530 Metz, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Tölle', 'Affiliation': 'Department of Neurology, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Delorme', 'Affiliation': ""Centre Hospitalier Aunay-Bayeux, centre d'évaluation et traitement de la douleur (CETD), 14400 Bayeux, France.""}, {'ForeName': 'Rodrigue', 'Initials': 'R', 'LastName': 'Deleens', 'Affiliation': ""Centre d'évaluation et de traitement de la douleur, CHU de Rouen, 76000 Rouen, France.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Giniès', 'Affiliation': ""Centre d'évaluation et de traitement de la douleur, Hôpital Saint-Eloi, CHRU Montpellier, 34000 Montpellier, France.""}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Corand-Dousset', 'Affiliation': ""Centre d'Evaluation et de Traitement de la Douleur, Hôpital Pellegrin, CHU de Bordeaux, 33000 Bordeaux, France.""}, {'ForeName': 'Clémence', 'Initials': 'C', 'LastName': 'Dal-Col', 'Affiliation': ""Centre d'Evaluation et de Traitement de la Douleur, CHRU Jean Minjoz, 25000 Besançon, France.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Serrie', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Lariboisière-Fernand-Widal, Universités Paris Descartes-Paris Diderot, service de médecine de la douleur et de médecine palliative, Inserm UMR-S 1144, 75010 Paris, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Chevrillon', 'Affiliation': 'Clinique du Bourget, RAMSAY Santé, 93350 Le Bourget, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gov', 'Affiliation': ""Centre d'Evaluation et de Traitement de la Douleur, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, 69677 Bron Cedex, France.""}, {'ForeName': 'Juan Fernando', 'Initials': 'JF', 'LastName': 'Ramirez-Gil', 'Affiliation': 'Air Liquide Santé International, Les Loges en Josas, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Delval', 'Affiliation': 'Air Liquide Santé International, Les Loges en Josas, France.'}, {'ForeName': 'Manuella', 'Initials': 'M', 'LastName': 'Schaller', 'Affiliation': 'Air Liquide Santé International, Les Loges en Josas, France.'}, {'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Bessière', 'Affiliation': 'Air Liquide Santé International, Les Loges en Josas, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Houéto', 'Affiliation': 'Air Liquide Santé International, Les Loges en Josas, France.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Sommer', 'Affiliation': 'Department of Neurology, University of Würzburg, Würzburg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pain,['10.1097/j.pain.0000000000002109']
2149,33044440,Caffeine Exacerbates Hyperventilation and Reductions in Cerebral Blood Flow in Physically Fit Males Exercising in the Heat.,"INTRODUCTION


Caffeine is an exercise performance enhancer widely used by individuals engaged in training or competition under heat-stressed conditions. Caffeine ingestion during exercise in the heat is believed to be safe, since it does not greatly affect body temperature responses, heart rate or body fluid status. However, it remains unknown whether caffeine affects hyperthermia-induced hyperventilation or reductions in the cerebral blood flow index. We tested the hypothesis that under conditions inducing severe hyperthermia, caffeine exacerbates hyperthermia-induced hyperventilation and reduces the cerebral blood flow index during exercise.
METHODS


Using a randomized, single-blind, crossover design, twelve physically active healthy young males (23±2 years) consumed a moderate dose of caffeine (5 mg/kg) or placebo in the heat (37°C). Approximately 60 min after the ingestion, they cycled for ~45 min at a workload equal to ~55% of their pre-determined peak oxygen uptake (moderate intensity) until their core temperature increased to 2.0°C above its pre-exercise baseline level.
RESULTS


In both trials, ventilation increased and the cerebral blood flow index assessed by middle cerebral artery mean blood velocity decreased as core temperature rose during exercise (P<0.05), indicating that hyperthermia-induced hyperventilation and lowering of the cerebral blood flow index occurred. When core temperature was elevated by 1.5°C or more (P<0.05), ventilation was higher and the cerebral blood flow index was lower throughout the caffeine trial than the placebo trial (P<0.05).
CONCLUSION


A moderate dose of caffeine exacerbates hyperthermia-induced hyperventilation and reductions in the cerebral blood flow index during exercise in the heat with severe hyperthermia.",2020,"In both trials, ventilation increased and the cerebral blood flow index assessed by middle cerebral artery mean blood velocity decreased as core temperature rose during exercise (P<0.05), indicating that hyperthermia-induced hyperventilation and lowering of the cerebral blood flow index occurred.","['Physically Fit Males', 'twelve physically active healthy young males (23±2 years']","['placebo', 'caffeine', 'Caffeine', 'Caffeine ingestion']","['cerebral blood flow index', 'cerebral blood flow index assessed by middle cerebral artery mean blood velocity', 'Cerebral Blood Flow', 'body temperature responses, heart rate or body fluid status']","[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",12.0,0.0395421,"In both trials, ventilation increased and the cerebral blood flow index assessed by middle cerebral artery mean blood velocity decreased as core temperature rose during exercise (P<0.05), indicating that hyperthermia-induced hyperventilation and lowering of the cerebral blood flow index occurred.","[{'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Fujii', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Fujimoto', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Yinhang', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Dobashi', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Matsutake', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Amano', 'Affiliation': 'Laboratory for Exercise and Environmental Physiology, Faculty of Education, Niigata University, Niigata, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Wanatabe', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nishiyasu', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Japan.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002537']
2150,33044441,A Single Bout of Premeal Resistance Exercise Improves Postprandial Glucose Metabolism in Obese Men with Prediabetes.,"INTRODUCTION


Prediabetes is a major risk factor for type 2 diabetes and cardiovascular diseases. While resistance exercise (RE) is recommended for individuals with prediabetes, the effects of RE on postprandial glucose metabolism in this population are poorly understood. Therefore, the purpose of this study was to elucidate how RE affects postprandial glucose kinetics, insulin sensitivity, beta cell function, and glucose oxidation during the subsequent meal in sedentary men with obesity and prediabetes.
METHODS


We studied 10 sedentary men with obesity (BMI: 33 ± 3 kg/m) and prediabetes by using a randomized, cross-over study design. After an overnight fast, participants completed either a single bout of whole-body RE (7 exercises, 3 sets of 10-12 repetitions at 80% 1-repetition maximum each) or an equivalent period of rest. Participants subsequently completed a mixed meal test in conjunction with an intravenous [6,6-H2]glucose infusion to determine basal and postprandial glucose rate of appearance (Ra) and disappearance (Rd) from plasma, insulin sensitivity, and the insulinogenic index (a measure of beta cell function). Skeletal muscle biopsies were obtained 90 min post-meal to evaluate pyruvate-supported and maximal mitochondrial respiration. Whole-body carbohydrate oxidation was assessed using indirect calorimetry.
RESULTS


RE significantly reduced the postprandial rise in glucose Ra and plasma glucose concentration. Postprandial insulin sensitivity was significantly greater after RE, while postprandial plasma insulin concentration was significantly reduced. RE had no effect on the insulinogenic index, postprandial pyruvate respiration, or carbohydrate oxidation.Conclusion/InterpretationA single bout of RE has beneficial effects on postprandial glucose metabolism in men with obesity and pre-diabetes by increasing postprandial insulin sensitivity, reducing the postprandial rise in glucose Ra, and reducing postprandial plasma insulin concentration.",2020,"RE had no effect on the insulinogenic index, postprandial pyruvate respiration, or carbohydrate oxidation.","['sedentary men with obesity and prediabetes', '10 sedentary men with obesity (BMI: 33 ± 3 kg/m) and prediabetes by using a randomized, cross-over study design', 'Obese Men with Prediabetes', 'individuals with prediabetes', 'men with obesity and pre-diabetes']","['Premeal Resistance Exercise', 'resistance exercise (RE']","['Postprandial Glucose Metabolism', 'insulinogenic index, postprandial pyruvate respiration, or carbohydrate oxidation', 'postprandial rise in glucose Ra and plasma glucose concentration', 'postprandial plasma insulin concentration', 'postprandial glucose kinetics, insulin sensitivity, beta cell function, and glucose oxidation', 'postprandial glucose rate of appearance (Ra) and disappearance (Rd) from plasma, insulin sensitivity, and the insulinogenic index (a measure of beta cell function', 'postprandial glucose metabolism', 'Postprandial insulin sensitivity']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034354', 'cui_str': 'Pyruvates'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",10.0,0.0452448,"RE had no effect on the insulinogenic index, postprandial pyruvate respiration, or carbohydrate oxidation.","[{'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Bittel', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Bittel', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Mittendorfer', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Adewole L', 'Initials': 'AL', 'LastName': 'Okunade', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Nada A', 'Initials': 'NA', 'LastName': 'Abumrad', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Dominic N', 'Initials': 'DN', 'LastName': 'Reeds', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'William Todd', 'Initials': 'WT', 'LastName': 'Cade', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine, St. Louis, MO.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002538']
2151,33044490,"Swab-yourself trial with economic monitoring and testing for infections collectively (SYSTEMATIC): Part 2. A diagnostic accuracy, and cost-effectiveness, study comparing rectal, pharyngeal and urogenital samples analysed individually, versus as a pooled specimen, for the diagnosis of gonorrhoea and chlamydia.","BACKGROUND


Sexual history does not accurately identify those with extragenital Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) so universal extragenital sampling is recommended. Nucleic acid amplification tests (NAATs) are expensive. If urogenital, plus rectal and pharyngeal, samples are analysed the diagnostic cost is trebled. Pooling samples into one NAAT container would cost the same as urogenital samples alone. We compared clinician triple samples analysed individually with self-taken pooled samples for diagnostic accuracy, and cost, in MSM and females.
METHODS


Prospective, convenience, sample in UK sexual health clinic. Randomised order of clinician and self-samples from pharynx, rectum, plus first catch urine (FCU) in MSM and vulvovaginal swabs (VVS) in females, for NG and CT detection.
RESULTS


Of 1793 participants (1284 females, 509 MSM), 116 had NG detected (75 urogenital, 83 rectum, 72 pharynx). 276 had CT detected (217 urogenital, 249 rectum, 63 pharynx).There was no difference in sensitivities between clinician triple samples and self-pooled specimens for NG (99.1%, 98.3%) but clinician samples analysed individually identified 3% more chlamydia infections than pooled (99.3%, 96.0%; p=0.027). However, pooled specimens identified more infections than VVS/FCU alone. Pooled specimens missed 2 NG and 11 CT infections, whereas VVS/FCU missed 41 NG and 58 CT infections. Self-taken pooled specimens were the most cost-effective.
CONCLUSIONS


Just FCU/VVS testing missed many infections. Self-taken pooled samples were as sensitive as clinician triple samples for identifying NG, but clinician samples analysed individually identified 3% more CT infections than pooled. The extragenital sampling was achievable at no additional diagnostic cost to the FCU/VVS.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02371109.",2020,"276 had CT detected (217 urogenital, 249 rectum, 63 pharynx).There was no difference in sensitivities between clinician triple samples and self-pooled specimens for NG (99.1%, 98.3%) but clinician samples analysed individually identified 3% more chlamydia infections than pooled (99.3%, 96.0%; p=0.027).","['Prospective, convenience, sample in UK sexual health clinic', '1793 participants (1284 females, 509 MSM']",[],['chlamydia infections'],"[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3839552', 'cui_str': 'Sexual health clinic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}]",[],"[{'cui': 'C0008149', 'cui_str': 'Chlamydial infection'}]",1793.0,0.0231615,"276 had CT detected (217 urogenital, 249 rectum, 63 pharynx).There was no difference in sensitivities between clinician triple samples and self-pooled specimens for NG (99.1%, 98.3%) but clinician samples analysed individually identified 3% more chlamydia infections than pooled (99.3%, 96.0%; p=0.027).","[{'ForeName': 'Janet D', 'Initials': 'JD', 'LastName': 'Wilson', 'Affiliation': 'Leeds Sexual Health, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Harriet E', 'Initials': 'HE', 'LastName': 'Wallace', 'Affiliation': 'Leeds Sexual Health, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Loftus-Keeling', 'Affiliation': 'Leeds Sexual Health, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ward', 'Affiliation': 'Department of Infectious Disease Epidemiology, Imperial College, London, UK.'}, {'ForeName': 'Bethan', 'Initials': 'B', 'LastName': 'Davies', 'Affiliation': 'Department of Epidemiology and Biostatistics, Imperial College, London, UK.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Vargas-Palacios', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hulme', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, UK.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Wilcox', 'Affiliation': 'Department of Clinical Microbiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1546']
2152,33044494,Concordance Between Blood Pressure in the Systolic Blood Pressure Intervention Trial and in Routine Clinical Practice.,"Importance


There are concerns with translating results from the Systolic Blood Pressure Intervention Trial (SPRINT) into clinical practice because the standardized protocol used to measure blood pressure (BP) may not be consistently applied in routine clinical practice.
Objectives


To evaluate the concordance between BPs obtained in routine clinical practice and those obtained using the SPRINT protocol and whether concordance varied by target trial BP.
Design, Setting, and Participants


This observational prognostic study linking outpatient vital sign information from electronic health records (EHRs) with data from 49 of the 102 SPRINT sites was conducted from November 8, 2010, to August 20, 2015, among 3074 adults 50 years or older with hypertension without diabetes or a history of stroke. Statistical analysis was performed from May 21, 2019, to March 20, 2020.
Main Outcomes and Measures


Blood pressures measured in routine clinical practice and SPRINT.
Results


Participant-level EHR data was obtained for 3074 participants (2482 men [80.7%]; mean [SD] age, 68.5 [9.1] years) with 3 or more outpatient and trial BP measurements. In the period from the 6-month study visit to the end of the study intervention, the mean systolic BP (SBP) in the intensive treatment group from outpatient BP recorded in the EHR was 7.3 mm Hg higher (95% CI, 7.0-7.6 mm Hg) than BP measured at trial visits; the mean difference between BP recorded in the outpatient EHR and trial SBP was smaller for participants in the standard treatment group (4.6 mm Hg [95% CI, 4.4-4.9 mm Hg]). Bland-Altman analyses demonstrated low agreement between outpatient BP recorded in the EHR and trial BP, with wide agreement intervals ranging from approximately -30 mm Hg to 45 mm Hg in both treatment groups. In addition, the difference between BP recorded in the EHR and trial BP varied widely by site.
Conclusions and Relevance


Outpatient BPs measured in routine clinical practice were generally higher than BP measurements taken in SPRINT, with greater mean SBP differences apparent in the intensive treatment group. There was a consistent high degree of heterogeneity between the BPs recorded in the EHR and trial BPs, with significant variability over time, between and within the participants, and across clinic sites. These results highlight the importance of proper BP measurement technique and an inability to apply 1 common correction factor (ie, approximately 10 mm Hg) to approximate research-quality BP estimates when BP is not measured appropriately in routine clinical practice.
Trial Registration


SPRINT ClinicalTrials.gov Identifier: NCT01206062.",2020,"SBP was smaller for participants in the standard treatment group (4.6 mm Hg [95% CI, 4.4-4.9 mm Hg]).","['3074 participants (2482 men [80.7%]; mean [SD] age, 68.5 [9.1] years) with 3 or more outpatient and trial BP measurements', 'outpatient vital sign information from electronic health records (EHRs) with data from 49 of the 102 SPRINT sites was conducted from November 8, 2010, to August 20, 2015, among 3074 adults 50 years or older with hypertension without diabetes or a history of stroke']",[],"['Measures\n\n\nBlood pressures measured in routine clinical practice and SPRINT', 'blood pressure (BP', 'mean systolic BP (SBP', 'SBP']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",[],"[{'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",3074.0,0.133004,"SBP was smaller for participants in the standard treatment group (4.6 mm Hg [95% CI, 4.4-4.9 mm Hg]).","[{'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Drawz', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Minnesota, Minneapolis.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Division of Nephrology, The Ohio State University Wexner Medical Center, Columbus.'}, {'ForeName': 'Jamie P', 'Initials': 'JP', 'LastName': 'Dwyer', 'Affiliation': 'Division of Nephrology/Hypertension, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Horwitz', 'Affiliation': 'Division of Nephrology and Hypertension, MetroHealth Medical Center, Case Western Reserve University. Cleveland, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lash', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Illinois, Chicago.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Lenoir', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McWilliams', 'Affiliation': 'Department of Internal Medicine, Center for Outcomes Research and Evaluation, Atrium Health, Charlotte, North Carolina.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': 'Division of Cardiovascular Disease, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Rahbari-Oskoui', 'Affiliation': 'Division of Renal Medicine, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Mahboob', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Parkulo', 'Affiliation': 'Division of Community Internal Medicine and Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Pemu', 'Affiliation': 'Department of Medicine, Morehouse School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Dominic S', 'Initials': 'DS', 'LastName': 'Raj', 'Affiliation': 'Division of Kidney Diseases and Hypertension, George Washington University, Washington, DC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rocco', 'Affiliation': 'Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Soman', 'Affiliation': 'Division of Nephrology and Hypertension, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Thomas', 'Affiliation': 'Department of Nephrology and Hypertension, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Delphine S', 'Initials': 'DS', 'LastName': 'Tuot', 'Affiliation': 'Division of Nephrology, University of California, San Francisco.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.5028']
2153,33044768,"Grape seed extract supplementation along with a restricted-calorie diet improves cardiovascular risk factors in obese or overweight adult individuals: A randomized, placebo-controlled trial.","Grape seed extract (GSE) is a flavonoid-rich supplement, recently discussed as a potential moderator of inflammation and obesity. In this study, we aimed to investigate the effects of GSE supplementation along with a restricted-calorie diet (RCD), on changes in blood lipid profile, visceral adiposity index (VAI), and atherogenic index of plasma (AIP). We designed a randomized, double-blinded, placebo-controlled clinical trial. Forty obese or overweight individuals (25 ≤ body mass index < 40 kg/m 2  ) were randomly assigned to receive GSE (300 mg/day) or placebo, plus RCD, for 12 weeks. We studied the anthropometric measures, biochemical biomarkers and dietary intake within the study timelines. Levels of high-density lipoprotein cholesterol (HDL-C) and HDL-C/low-density lipoprotein cholesterol (LDL-C) significantly increased in the GSE group as compared with the placebo group at week 12 (p = .03 and .008, respectively, adjusted for age, sex, energy and saturated fatty acid intake). We also observed a significant reduction in LDL-C following GSE supplementation in comparison to placebo (adjusted for age, sex and energy intake, p = .04). VAI, AIP, total cholesterol and triglyceride significantly decreased in the GSE group compared with the baseline (p = .04, .02, .01, and .02, respectively). GSE supplementation may have a modulatory role in improving blood lipid profile in obese or overweight individuals, when accompanied by RCD.",2020,"VAI, AIP, total cholesterol and triglyceride significantly decreased in the GSE group compared with the baseline (p = .04, .02, .01, and .02, respectively).","['obese or overweight individuals', 'obese or overweight adult individuals', 'Forty obese or overweight individuals (25\u2009≤\u2009body mass index\u2009<\u200940\u2009kg/m 2  ']","['restricted-calorie diet (RCD', 'Grape seed extract (GSE', 'GSE supplementation', 'placebo', 'placebo, plus RCD', 'Grape seed extract supplementation', 'calorie diet', 'GSE']","['cardiovascular risk factors', 'Levels of high-density lipoprotein cholesterol (HDL-C) and HDL-C/low-density lipoprotein cholesterol (LDL-C', 'blood lipid profile, visceral adiposity index (VAI), and atherogenic index of plasma (AIP', 'blood lipid profile', 'VAI, AIP, total cholesterol and triglyceride', 'LDL-C']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet'}, {'cui': 'C0772454', 'cui_str': 'Grape Seed Extract'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",40.0,0.660637,"VAI, AIP, total cholesterol and triglyceride significantly decreased in the GSE group compared with the baseline (p = .04, .02, .01, and .02, respectively).","[{'ForeName': 'Reyhaneh', 'Initials': 'R', 'LastName': 'Yousefi', 'Affiliation': 'Department of Health, Kinesiology, and Applied Physiology, Concordia University, and Montréal Behavioural Medicine Centre, CIUSSS-NIM, Hôpital du Sacré-Coeur de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Parandoosh', 'Affiliation': 'Faculty of Nutrition Sciences and Food Technology, Department of Clinical Nutrition & Dietetics, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Khorsandi', 'Affiliation': 'Faculty of Nutrition Sciences and Food Technology, Department of Clinical Nutrition & Dietetics, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Hosseinzadeh', 'Affiliation': 'Faculty of Biostatistics, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Madani Tonekaboni', 'Affiliation': 'Vice-Chancellery of Food and Drug, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Atoosa', 'Initials': 'A', 'LastName': 'Saidpour', 'Affiliation': 'Faculty of Nutrition Sciences and Food Technology, Department of Clinical Nutrition & Dietetics, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Babaei', 'Affiliation': 'Drug Applied Research Center, School of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Ghorbani', 'Affiliation': 'Faculty of Nutrition Science and Food Technology, Department of Cellular and Molecular Nutrition, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6859']
2154,33044793,FDA Supplemental Approval Summary: Lenvatinib for the Treatment of Unresectable Hepatocellular Carcinoma.,"On August 16, 2018, the Food and Drug Administration (FDA) approved lenvatinib (Lenvima®, Eisai Inc.) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Approval was based on an international, multicenter, randomized, open-label, non-inferiority trial (REFLECT; NCT01761266) conducted in 954 patients with previously untreated, metastatic or unresectable HCC. Patients were randomized (1:1) to receive lenvatinib (12 mg orally once daily for patients with a baseline body weight ≥ 60 kg and 8 mg orally once daily for patients with a baseline body weight < 60 kg) or sorafenib (400 mg orally twice daily) until radiological disease progression or unacceptable toxicity. REFLECT demonstrated that lenvatinib was non-inferior but not statistically superior to sorafenib for overall survival (OS) [Hazard ratio (HR) 0.92; [95% confidence intervals (CI): 0.79, 1.06]), with median OS of 13.6 and 12.3 months in the lenvatinib and sorafenib arms, respectively. REFLECT also demonstrated statistically significant improvements in investigator-assessed progression-free survival (PFS) (HR 0.66 [95% CI: 0.57, 0.77]; p<0.001), corresponding to median PFS of 7.4 and 3.7 months and overall response rate (ORR) of 24.1% vs 9.2% per modified RECIST for HCC (mRECIST) in the lenvatinib and sorafenib arms, respectively. Consistent results were observed by an independent review facility (IRF) per RECISTv1.1 and per mRECIST. The most common adverse reactions observed in the lenvatinib-treated patients (≥20%) in decreasing frequency were hypertension, fatigue, diarrhea, decreased appetite, arthralgia/myalgia, decreased weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism, and nausea. IMPLICATIONS FOR PRACTICE: This article describes FDA's review of data from a single trial, REFLECT, that supported the approval of lenvatinib, as a single agent, for the first-line treatment of unresectable hepatocellular carcinoma (HCC). REFLECT was an open-label, non-inferiority trial that randomized 954 patients with HCC who were ineligible for liver-directed therapy with no prior systemic therapy for HCC to lenvatinib or sorafenib. REFLECT demonstrated that lenvatinib-treated patients had similar survival, more responses, and longer time to progression than those receiving sorafenib. Serious side effects were more common among lenvatinib-treated patients. Lenvatinib is an effective treatment for patients with previously untreated HCC.",2020,"REFLECT also demonstrated statistically significant improvements in investigator-assessed progression-free survival (PFS) (HR 0.66 [95% CI: 0.57, 0.77]; p<0.001), corresponding to median PFS of 7.4 and 3.7 months and overall response rate (ORR) of 24.1% vs 9.2% per modified RECIST for HCC (mRECIST) in the lenvatinib and sorafenib arms, respectively.","['patients with unresectable hepatocellular carcinoma (HCC', '954 patients with previously untreated, metastatic or unresectable HCC', 'patients with previously untreated HCC', '954 patients with HCC who were ineligible for liver-directed therapy with no prior systemic therapy for HCC to lenvatinib or', 'Unresectable Hepatocellular Carcinoma', 'unresectable hepatocellular carcinoma (HCC']","['sorafenib', 'lenvatinib']","['overall survival (OS', 'overall response rate (ORR', 'adverse reactions', 'hypertension, fatigue, diarrhea, decreased appetite, arthralgia/myalgia, decreased weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism, and nausea', 'Serious side effects', 'investigator-assessed progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C2986924', 'cui_str': 'lenvatinib'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C2986924', 'cui_str': 'lenvatinib'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",954.0,0.134329,"REFLECT also demonstrated statistically significant improvements in investigator-assessed progression-free survival (PFS) (HR 0.66 [95% CI: 0.57, 0.77]; p<0.001), corresponding to median PFS of 7.4 and 3.7 months and overall response rate (ORR) of 24.1% vs 9.2% per modified RECIST for HCC (mRECIST) in the lenvatinib and sorafenib arms, respectively.","[{'ForeName': 'Abhilasha', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'Center for Drug Evaluation and Research.'}, {'ForeName': 'Kelie', 'Initials': 'K', 'LastName': 'Reece', 'Affiliation': 'Center for Drug Evaluation and Research.'}, {'ForeName': 'Martha B', 'Initials': 'MB', 'LastName': 'Donoghue', 'Affiliation': 'Center for Drug Evaluation and Research.'}, {'ForeName': 'Weishi Vivian', 'Initials': 'WV', 'LastName': 'Yuan', 'Affiliation': 'Center for Drug Evaluation and Research.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Rodriguez', 'Affiliation': 'Center for Drug Evaluation and Research.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Keegan', 'Affiliation': 'Oncology Center for Excellence, U.S. Food and Drug Administration.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Center for Drug Evaluation and Research.'}]",The oncologist,['10.1002/onco.13566']
2155,33038932,A cluster randomized controlled trial on a multifaceted implementation strategy to promote integrated palliative care in COPD: study protocol of the COMPASSION study.,"BACKGROUND


Despite the urgent need for palliative care for patients with advanced chronic obstructive pulmonary disease (COPD), it is not yet daily practice. Important factors influencing the provision of palliative care are adequate communication skills, knowing when to start palliative care and continuity of care. In the COMPASSION study, we address these factors by implementing an integrated palliative care approach for patients with COPD and their informal caregivers.
METHODS


An integrated palliative care intervention was developed based on existing guidelines, a literature review, and input from patient and professional organizations. To facilitate uptake of the intervention, a multifaceted implementation strategy was developed, comprising a toolbox, (communication) training, collaboration support, action planning and monitoring. Using a hybrid effectiveness-implementation type 2 design, this study aims to simultaneously evaluate the implementation process and effects on patient, informal caregiver and professional outcomes. In a cluster randomized controlled trial, eight hospital regions will be randomized to receive the integrated palliative care approach or to provide care as usual. Eligible patients are identified during hospitalization for an exacerbation using the Propal-COPD tool. The primary outcome is quality of life (FACIT-Pal) at 6 months. Secondary outcome measures include spiritual well-being, anxiety and depression, unplanned healthcare use, informal caregiver burden and healthcare professional's self-efficacy to provide palliative care. The implementation process will be investigated by a comprehensive mixed-methods evaluation assessing the following implementation constructs: context, reach, dose delivered, dose received, fidelity, implementation level, recruitment, maintenance and acceptability. Furthermore, determinants to implementation will be investigated using the Consolidated Framework for Implementation Research.
DISCUSSION


The COMPASSION study will broaden knowledge on the effectiveness and process of palliative care integration into COPD-care. Furthermore, it will improve our understanding of which strategies may optimize the implementation of integrated palliative care.
TRIAL REGISTRATION


Netherlands Trial Register (NTR): NL7644 . Registration date: April 7, 2019.",2020,"Important factors influencing the provision of palliative care are adequate communication skills, knowing when to start palliative care and continuity of care.","['patients with advanced chronic obstructive pulmonary disease (COPD', 'patients with COPD and their informal caregivers', 'Eligible patients are identified during hospitalization for an exacerbation using the Propal-COPD tool', 'COPD']","['multifaceted implementation strategy', 'integrated palliative care approach or to provide care as usual']","[""spiritual well-being, anxiety and depression, unplanned healthcare use, informal caregiver burden and healthcare professional's self-efficacy to provide palliative care"", 'quality of life (FACIT-Pal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.177903,"Important factors influencing the provision of palliative care are adequate communication skills, knowing when to start palliative care and continuity of care.","[{'ForeName': 'Johanna M C', 'Initials': 'JMC', 'LastName': 'Broese', 'Affiliation': 'Public Health and Primary care, Leiden University Medical Centre, Post zone V0-P, Postbox 9600, 2300 RC, Leiden, The Netherlands. j.m.c.broese@lumc.nl.'}, {'ForeName': 'Rianne M J J', 'Initials': 'RMJJ', 'LastName': 'van der Kleij', 'Affiliation': 'Public Health and Primary care, Leiden University Medical Centre, Post zone V0-P, Postbox 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Respiratory Medicine and Tuberculosis, and Groningen Research Institute for Asthma and COPD (GRIAC), University of Groningen and University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Els M L', 'Initials': 'EML', 'LastName': 'Verschuur', 'Affiliation': 'Lung Alliance Netherlands, Amersfoort, The Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Engels', 'Affiliation': 'Anaesthesiology, Pain and Palliative Medicine, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Chavannes', 'Affiliation': 'Public Health and Primary care, Leiden University Medical Centre, Post zone V0-P, Postbox 9600, 2300 RC, Leiden, The Netherlands.'}]",BMC palliative care,['10.1186/s12904-020-00657-3']
2156,33038944,Redevelopment and validation of the SYNTAX score II to individualise decision making between percutaneous and surgical revascularisation in patients with complex coronary artery disease: secondary analysis of the multicentre randomised controlled SYNTAXES trial with external cohort validation.,"BACKGROUND


Randomised controlled trials are considered the gold standard for testing the efficacy of novel therapeutic interventions, and typically report the average treatment effect as a summary result. As the result of treatment can vary between patients, basing treatment decisions for individual patients on the overall average treatment effect could be suboptimal. We aimed to develop an individualised decision making tool to select an optimal revascularisation strategy in patients with complex coronary artery disease.
METHODS


The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries between March, 2005, and April, 2007. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to either the percutaneous coronary intervention (PCI) group or coronary artery bypass grafting (CABG) group. The SYNTAXES study ascertained 10-year all-cause deaths. We used Cox regression to develop a clinical prognostic index for predicting death over a 10-year period, which was combined, in a second stage, with assigned treatment (PCI or CABG) and two prespecified effect-modifiers, which were selected on the basis of previous evidence: disease type (three-vessel disease or left main coronary artery disease) and anatomical SYNTAX score. We used similar techniques to develop a model to predict the 5-year risk of major adverse cardiovascular events (defined as a composite of all-cause death, non-fatal stroke, or non-fatal myocardial infarction) in patients receiving PCI or CABG. We then assessed the ability of these models to predict the risk of death or a major adverse cardiovascular event, and their differences (ie, the estimated benefit of CABG versus PCI by calculating the absolute risk difference between the two strategies) by cross-validation with the SYNTAX trial (n=1800 participants) and external validation in the pooled population (n=3380 participants) of the FREEDOM, BEST, and PRECOMBAT trials. The concordance (C)-index was used to measure discriminative ability, and calibration plots were used to assess the degree of agreement between predictions and observations.
FINDINGS


At cross-validation, the newly developed SYNTAX score II, termed SYNTAX score II 2020, showed a helpful discriminative ability in both treatment groups for predicting 10-year all-cause deaths (C-index=0·73 [95% CI 0·69-0·76] for PCI and 0·73 [0·69-0·76] for CABG) and 5-year major adverse cardiovascular events (C-index=0·65 [0·61-0·69] for PCI and C-index=0·71 [0·67-0·75] for CABG). At external validation, the SYNTAX score II 2020 showed helpful discrimination (C-index=0·67 [0·63-0·70] for PCI and C-index=0·62 [0·58-0·66] for CABG) and good calibration for predicting 5-year major adverse cardiovascular events. The estimated treatment benefit of CABG over PCI varied substantially among patients in the trial population, and the benefit predictions were well calibrated.
INTERPRETATION


The SYNTAX score II 2020 for predicting 10-year deaths and 5-year major adverse cardiovascular events can help to identify individuals who will benefit from either CABG or PCI, thereby supporting heart teams, patients, and their families to select optimal revascularisation strategies.
FUNDING


The German Heart Research Foundation and the Patient-Centered Outcomes Research Institute.",2020,"At external validation, the SYNTAX score II 2020 showed helpful discrimination (C-index=0·67 [0·63-0·70] for PCI and C-index=0·62 [0·58-0·66] for CABG) and good calibration for predicting 5-year major adverse cardiovascular events.","['patients receiving PCI or CABG', 'patients with complex coronary artery disease', 'Patients with de-novo three-vessel and left main coronary artery disease', '85 hospitals across 18 North American and European countries between March, 2005, and April, 2007']","['CABG', 'percutaneous and surgical revascularisation', 'percutaneous coronary intervention (PCI) group or coronary artery bypass grafting (CABG']","['10-year deaths and 5-year major adverse cardiovascular events', '5-year major adverse cardiovascular events', '5-year risk of major adverse cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1299433', 'cui_str': 'Left main coronary artery disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1800.0,0.111592,"At external validation, the SYNTAX score II 2020 showed helpful discrimination (C-index=0·67 [0·63-0·70] for PCI and C-index=0·62 [0·58-0·66] for CABG) and good calibration for predicting 5-year major adverse cardiovascular events.","[{'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway, Ireland. Electronic address: patrick.w.j.c.serruys@gmail.com.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'Zena and Michael Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Centro Nacional De Investigaciones Cardiovasculares Carlos III, Madrid, Spain.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Farkouh', 'Affiliation': 'Peter Munk Cardiac Centre and The Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO, USA; University of Missouri-Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'University of Missouri-Kansas City, Kansas City, MO, USA.'}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Duk-Woo', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Ahn', 'Affiliation': 'Department of Cardiology, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Arie Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Head', 'Affiliation': 'Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Daniel Jfm', 'Initials': 'DJ', 'LastName': 'Thuijs', 'Affiliation': 'Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kent', 'Affiliation': 'Predictive Analytics and Comparative Effectiveness Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Ewout W', 'Initials': 'EW', 'LastName': 'Steyerberg', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden, Netherlands; University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'van Klaveren', 'Affiliation': 'Department of Public Health, Erasmus University Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)32114-0']
2157,33038950,"Effect on mortality of increasing the cutoff blood glucose concentration for initiating hypoglycaemia treatment in severely sick children aged 1 month to 5 years in Malawi (SugarFACT): a pragmatic, randomised controlled trial.","BACKGROUND


Low blood glucose concentrations are common in sick children who present to hospital in low-resource settings and are associated with increased mortality. The cutoff blood glucose concentration for the diagnosis and treatment of hypoglycaemia currently recommended by WHO (2·5 mmol/L) is not evidence-based. We aimed to assess whether increasing the cutoff blood glucose concentration for hypoglycaemia treatment in severely ill children at presentation to hospital improves mortality outcomes.
METHODS


We did a pragmatic, randomised controlled trial at two referral hospitals in Malawi. Severely ill children aged 1 month to 5 years presenting to the emergency department with a capillary blood glucose concentration of between 2·5 mmol/L (3·0 mmol/L in severely malnourished children) and 5·0 mmol/L were randomly assigned (1:1) by a computer-generated randomisation sequence, stratified by study site and severe malnutrition, to receive either an immediate intravenous bolus of 10% dextrose at 5 mL/kg followed by a 24-h maintenance infusion of 10% dextrose at 100 mL/kg for the first 10 kg of bodyweight, 50 mL/kg for the next 10 kg, and 20 mL/kg for each subsequent kg of bodyweight (intervention group) or observation for a minimum of 60 min and standard care (control group). Participants and study personnel were not masked to treatment allocation. The primary outcome was all-cause in-hospital mortality, assessed on an intention-to-treat basis. Safety was also assessed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT02989675.
FINDINGS


Between Dec 5, 2016, and Jan 22, 2019, 10 947 children were screened, of whom 332 were randomly assigned, and 322 were included in the final analysis (n=162 in the control group and n=160 in the intervention group). The study was terminated after an interim analysis at 24% enrolment indicated futility. The median age of participants was 2·3 years (IQR 1·4-3·2), 65 (45%) were female, and the baseline characteristics of participants were similar between the two groups. The number of in-hospital deaths from any cause was 26 (16%) in the control group and 24 (15%) in the intervention group, with an absolute mortality difference of 1·0% (95% CI -6·9 to 9·0). Serious adverse events, including hypoglycaemia, hyperglycaemia, convulsions, reduced consciousness, and death, were reported in 47 (29%) children in the control group and 39 (24%) children in the intervention group.
INTERPRETATION


Increasing the cutoff blood glucose concentration for hypoglycaemia treatment in severely sick children in Malawi from 2·5 mmol/L to 5·0 mmol/L did not reduce all-cause in-hospital mortality. Our findings do not support changing the cutoff for dextrose administration, and further research on the optimal management of severely ill children who present to the emergency department with low blood glucose concentrations is warranted.
FUNDING


Swedish Research Council and Stockholm Country Council.",2020,"Serious adverse events, including hypoglycaemia, hyperglycaemia, convulsions, reduced consciousness, and death, were reported in 47 (29%) children in the control group and 39 (24%) children in the intervention group.
","['Severely ill children aged 1 month to 5 years presenting to the emergency department with a capillary blood glucose concentration of between 2·5 mmol/L (3·0 mmol/L in severely malnourished children) and 5·0 mmol/L', 'sick children', 'severely sick children', 'two referral hospitals in Malawi', 'Between Dec 5, 2016, and Jan 22, 2019, 10\u2008947 children were screened, of whom 332 were randomly assigned, and 322 were included in the final analysis (n=162 in the control group and n=160 in the intervention group', 'severely ill children', 'severely sick children aged 1 month to 5 years in Malawi (SugarFACT']","['bodyweight (intervention group) or observation for a minimum of 60 min and standard care (control group', 'immediate intravenous bolus of 10% dextrose at 5 mL/kg followed by a 24-h maintenance infusion of 10% dextrose']","['Safety', 'number of in-hospital deaths', 'cutoff blood glucose concentration', 'cause in-hospital mortality, assessed on an intention-to-treat basis', 'mortality of increasing the cutoff blood glucose concentration', 'Serious adverse events, including hypoglycaemia, hyperglycaemia, convulsions, reduced consciousness, and death']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0260101', 'cui_str': 'Sick child'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}]",10947.0,0.295853,"Serious adverse events, including hypoglycaemia, hyperglycaemia, convulsions, reduced consciousness, and death, were reported in 47 (29%) children in the control group and 39 (24%) children in the intervention group.
","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Baker', 'Affiliation': 'Health System and Policy, Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden; Department of Anaesthesia and Intensive Care, Queen Elizabeth Central Hospital, Blantyre, Malawi; Department of Paediatrics, College of Medicine, University of Malawi, Blantyre, Malawi; Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden. Electronic address: tim.baker@ki.se.'}, {'ForeName': 'Fatsani', 'Initials': 'F', 'LastName': 'Ngwalangwa', 'Affiliation': 'Department of Paediatrics, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Henderson', 'Initials': 'H', 'LastName': 'Masanjala', 'Affiliation': 'Department of Paediatrics, Queen Elizabeth Central Hospital, Blantyre, Malawi.'}, {'ForeName': 'Queen', 'Initials': 'Q', 'LastName': 'Dube', 'Affiliation': 'Department of Paediatrics, Queen Elizabeth Central Hospital, Blantyre, Malawi.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Langton', 'Affiliation': 'Department of Paediatrics, Queen Elizabeth Central Hospital, Blantyre, Malawi; Department of Paediatrics, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Marrone', 'Affiliation': 'Health System and Policy, Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Hildenwall', 'Affiliation': ""Health System and Policy, Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden; Department of Paediatrics, Queen Elizabeth Central Hospital, Blantyre, Malawi; Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden.""}]",The Lancet. Global health,['10.1016/S2214-109X(20)30388-0']
2158,33039134,[Complementary and alternative medicine in cancer patients and randomized controlled trials].,"More and more cancer patients around the world are using complementary and alternative medicine. They are mostly used as a complement to conventional care in decreasing the side effects of treatment and improving their quality of life. However, patients often use them without reporting it to their oncologists; the main reasons being the short duration of consultation and the fact that their oncologists do not support them due to a lack of scientific evidence. There are hundreds of them, some of which are now being used in French healthcare institutions as supportive care. The randomized controlled trial is the gold standard of evidence-based medicine, which is why we have carried out an overview of randomized controlled trials carried out around the world on alternative and complementary medicine.",2020,"The randomized controlled trial is the gold standard of evidence-based medicine, which is why we have carried out an overview of randomized controlled trials carried out around the world on alternative and complementary medicine.",['cancer patients'],['Complementary and alternative medicine'],[],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}]",[],,0.107374,"The randomized controlled trial is the gold standard of evidence-based medicine, which is why we have carried out an overview of randomized controlled trials carried out around the world on alternative and complementary medicine.","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Murat-Ringot', 'Affiliation': 'Université de Lyon, université Claude-Bernard Lyon 1, HESPER EA7425, 69008 Lyon, France; Hospices civils de Lyon, hôpital Lyon Sud, 165, chemin du Grand-Revoyet, 69495 Pierre-Bénite cedex, France; Université Lyon 2, institut de psychologie, laboratoire GRePS, EA 4163, 5, avenue P.\xa0-Mendès-France, 69676 Bron, France. Electronic address: audrey.ringot@chu-lyon.fr.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Preau', 'Affiliation': 'Université Lyon 2, institut de psychologie, laboratoire GRePS, EA 4163, 5, avenue P.\xa0-Mendès-France, 69676 Bron, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Piriou', 'Affiliation': 'Université de Lyon, université Claude-Bernard Lyon 1, HESPER EA7425, 69008 Lyon, France; Hospices civils de Lyon, hôpital Lyon Sud, 165, chemin du Grand-Revoyet, 69495 Pierre-Bénite cedex, France.'}]",Bulletin du cancer,['10.1016/j.bulcan.2020.08.013']
2159,33039185,Impact of adding palatal rugae to complete dentures on patient satisfaction and oral health-related quality of life: A randomized crossover clinical trial.,"STATEMENT OF PROBLEM


The addition of palatal rugae to complete dentures has been suggested to improve the satisfaction of patients with different oral functions. However, clinical studies to support these claims are lacking.
PURPOSE


The purpose of this randomized, single-blind, 2-period crossover trial was to assess the satisfaction of edentulous patients and their oral health impact profile when provided with complete dentures with palatal rugae compared with a polished palate.
MATERIAL AND METHODS


Edentulous patients aged 45 to 80 years, with no relevant medical conditions, seeking complete dentures at a university hospital between May and July 2019 were recruited. Each participant received new complete dentures. After a 1-week adaptation period, the participants were randomly allocated to 2 sequences through a computer-generated sequence. In the first sequence, palatal rugae were added to the complete dentures, and after 2 months, the palatal rugae were removed and the dentures used for another 2 months. In the second sequence, the opposite sequence was followed: polished palate first and palatal rugae second. After each period, a blinded dentist asked participants to rate their general satisfaction on a 100-mm visual analog scale (primary outcome) and to rate their satisfaction regarding eating, taste perception, speaking, phonetics, and ease of cleaning. Participants were also asked to fill the 20-item oral health impact profile for edentulous patients (OHIP-EDENT). The paired sample t test and the Wilcoxon test were used (α=.05).
RESULTS


Fifty participants were randomized, of whom 6 dropped out. No significant differences were found between ratings for the 2 palatal contours in terms of general satisfaction 2.32 (95% confidence interval: -3.65 to 8.29, P=.438), eating 1.70 (95% confidence interval: -4.05 to 7.46, P=.554), taste perception 0.57 (95% confidence interval -5.04 to 6.17, P=.839), phonetics 1.48 (95% confidence interval -4.46 to 7.41, P=.618), or speaking 3.68 (95% confidence interval: -1.92 to 9.28, P=.192). However, satisfaction with ease of cleaning dentures with palatal rugae was significantly less 12.16 (95% confidence interval: 6.81 to 17.50, P<.001). The differences in the OHIP-EDENT total scores were not significantly different -1.75 (95% confidence interval: -3.7 to 0.23, P=.082). Differences in each item ratings were also found to be not significantly different (P>.05), except for the frequency of mealtime interruption (P=.041), which was reported to increase when rugae had been provided.
CONCLUSIONS


Complete dentures with palatal rugae were not perceived to improve patient satisfaction or oral health-related quality of life. However, they were perceived to be more difficult to clean and to increase frequency of interruptions during eating.",2020,No significant differences were found between ratings for the 2 palatal contours in terms of general satisfaction 2.32,"['Fifty participants', 'Edentulous patients aged 45 to 80 years, with no relevant medical conditions, seeking complete dentures at a university hospital between May and July 2019 were recruited', 'edentulous patients and their oral health impact profile when provided with complete dentures with palatal rugae compared with a polished palate']",['palatal rugae to complete dentures'],"['patient satisfaction or oral health-related quality of life', 'satisfaction with ease of cleaning dentures with palatal rugae', 'patient satisfaction and oral health-related quality of life', '100-mm visual analog scale (primary outcome) and to rate their satisfaction regarding eating, taste perception, speaking, phonetics, and ease of cleaning', 'taste perception 0.57', 'OHIP-EDENT total scores']","[{'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1720477', 'cui_str': 'When'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}]","[{'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600133', 'cui_str': 'Does clean own dentures'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0031579', 'cui_str': 'Phonetics'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",50.0,0.212375,No significant differences were found between ratings for the 2 palatal contours in terms of general satisfaction 2.32,"[{'ForeName': 'Motasum', 'Initials': 'M', 'LastName': 'Abu-Awwad', 'Affiliation': 'Assistant Professor, Prosthodontic Department, University of Jordan School of Dentistry, Amman, Jordan. Electronic address: motasum@gmail.com.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Ereifej', 'Affiliation': 'Associate Professor, Prosthodontic Department, University of Jordan School of Dentistry, Amman, Jordan.'}, {'ForeName': 'Mais', 'Initials': 'M', 'LastName': 'Al-Hattab', 'Affiliation': 'General Dental Practitioner and Private practice, Amman, Jordan.'}, {'ForeName': 'Dima Abu', 'Initials': 'DA', 'LastName': 'Baker', 'Affiliation': 'Research Assistant, Prosthodontic Department, University of Jordan School of Dentistry, Amman, Jordan.'}, {'ForeName': 'Haralampos', 'Initials': 'H', 'LastName': 'Petridis', 'Affiliation': 'Professor and Chair, Prosthodontics Unit, University College London Eastman Dental Institute, London, United Kingdom.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2020.09.002']
2160,33039205,"Re: Hiten D. Patel, Farzana A. Faisal, Bruce J. Trock, et al. Effect of Pharmacologic Prophylaxis on Venous Thromboembolism After Radical Prostatectomy: The PREVENTER Randomized Clinical Trial. Eur Urol 2020;78:360-8.",,2020,,[],"['Radical Prostatectomy', 'Pharmacologic Prophylaxis']",['Venous Thromboembolism'],[],"[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",,0.0320834,,"[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Department of Urology, Robotics and Renal Transplant, Max Super Speciality Hospital Saket, New Delhi, India. Electronic address: dramitbansalurology@gmail.com.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Urology, Robotics and Renal Transplant, Max Super Speciality Hospital Saket, New Delhi, India.'}]",European urology,['10.1016/j.eururo.2020.09.040']
2161,33037080,Baricitinib-associated changes in global gene expression during a 24-week phase II clinical systemic lupus erythematosus trial implicates a mechanism of action through multiple immune-related pathways.,"OBJECTIVE


To characterise the molecular pathways impacted by the pharmacologic effects of the Janus kinase (JAK) 1 and JAK2 inhibitor baricitinib in SLE.
METHODS


In a phase II, 24-week, randomised, placebo-controlled, double-blind study (JAHH), RNA was isolated from whole blood in 274 patients and analysed using Affymetrix HTA2.0 array. Serum cytokines were measured using ultrasensitive quantitative assays.
RESULTS


Gene expression profiling demonstrated an elevation of  STAT1 ,  STAT2  and multiple interferon (IFN) responsive genes at baseline in patients with SLE. Statistical and gene network analyses demonstrated that baricitinib treatment reduced the mRNA expression of functionally interconnected genes involved in SLE including  STAT1 -target,  STAT2 -target and  STAT4- target genes and multiple IFN responsive genes. At baseline, serum cytokines IFN-α, IFN-γ, interleukin (IL)-12p40 and IL-6 were measurable and elevated above healthy controls. Treatment with baricitinib significantly decreased serum IL-12p40 and IL-6 cytokine levels at week 12, which persisted through week 24.
CONCLUSION


Baricitinib treatment induced significant reduction in the RNA expression of a network of genes associated with the JAK/STAT pathway, cytokine signalling and SLE pathogenesis. Baricitinib consistently reduced serum levels of two key cytokines implicated in SLE pathogenesis, IL-12p40 and IL-6.",2020,"Treatment with baricitinib significantly decreased serum IL-12p40 and IL-6 cytokine levels at week 12, which persisted through week 24.
CONCLUSION


Baricitinib treatment induced significant reduction in the RNA expression of a network of genes associated with the JAK/STAT pathway, cytokine signalling and SLE pathogenesis.",['274 patients and analysed using Affymetrix HTA2.0 array'],"['target and  STAT4', 'placebo']","['Serum cytokines', 'serum IL-12p40 and IL-6 cytokine levels', 'elevation of  STAT1 ,  STAT2  and multiple interferon (IFN) responsive genes', 'mRNA expression', 'serum cytokines IFN-α, IFN-γ, interleukin (IL)-12p40 and IL-6', 'global gene expression', 'RNA expression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0255034', 'cui_str': 'STAT4 Protein'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C1099914', 'cui_str': 'IL12B protein, human'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1432814', 'cui_str': 'STAT1 protein, human'}, {'cui': 'C0295166', 'cui_str': 'Transcription Factor STAT2'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}]",274.0,0.116982,"Treatment with baricitinib significantly decreased serum IL-12p40 and IL-6 cytokine levels at week 12, which persisted through week 24.
CONCLUSION


Baricitinib treatment induced significant reduction in the RNA expression of a network of genes associated with the JAK/STAT pathway, cytokine signalling and SLE pathogenesis.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dörner', 'Affiliation': 'DRFZ Berlin and Department of Rheumatology and Clinical Immunology, Charite University Hospital Berlin, Berlin, Germany thomas.doerner@charite.de.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational & Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Petri', 'Affiliation': 'Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Wallace', 'Affiliation': 'Department of Rheumatology, Cedars-Sinai Medical Center, West Hollywood, California, USA.'}, {'ForeName': 'Ernst R', 'Initials': 'ER', 'LastName': 'Dow', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Higgs', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Rocha', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Crowe', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Benschop', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Byers', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Silk', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'de Bono', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Fantini', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Hoffman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}]",Lupus science & medicine,['10.1136/lupus-2020-000424']
2162,33037118,"Avelumab as second-line therapy for metastatic, platinum-treated urothelial carcinoma in the phase Ib JAVELIN Solid Tumor study: 2-year updated efficacy and safety analysis.","BACKGROUND


Anti-programmed cell death ligand 1 (PD-L1)/programmed cell death 1 antibodies have shown clinical activity in platinum-treated metastatic urothelial carcinoma, resulting in regulatory approval of several agents, including avelumab (anti-PD-L1). We report ≥2-year follow-up data for avelumab treatment and exploratory subgroup analyses in patients with urothelial carcinoma.
METHODS


Patients with previously treated advanced/metastatic urothelial carcinoma, pooled from two cohorts of the phase Ib JAVELIN Solid Tumor trial, received avelumab 10 mg/kg every 2 weeks until disease progression, unacceptable toxicity or withdrawal. End points included best overall response and progression-free survival (PFS) per RECIST V.1.1, overall survival (OS) and safety. Post hoc analyses included objective response rates (ORRs) in subgroups defined by established high-risk/poor-prognosis characteristics and association between time to response and outcome.
RESULTS


249 patients received avelumab; efficacy was assessed in 242 postplatinum patients. Median follow-up was 31.9 months (range 24-43), and median treatment duration was 2.8 months (range 0.5-42.8). The confirmed ORR was 16.5% (95% CI 12.1% to 21.8%; complete response in 4.1% and partial response in 12.4%). Median duration of response was 20.5 months (95% CI 9.7 months to not estimable). Median PFS was 1.6 months (95% CI 1.4 to 2.7 months) and the 12-month PFS rate was 16.8% (95% CI 11.9% to 22.4%). Median OS was 7.0 months (95% CI 5.9 to 8.5 months) and the 24-month OS rate was 20.1% (95% CI 15.2% to 25.4%). In post hoc exploratory analyses, avelumab showed antitumor activity in high-risk subgroups, including elderly patients and those with renal insufficiency or upper tract disease; ORRs were numerically lower in patients with liver metastases or low albumin levels. Objective response achieved by 3 months versus later was associated with longer OS (median not reached (95% CI 18.9 months to not estimable) vs 7.1 months (95% CI 5.2 to 9.0 months)). Safety findings were consistent with previously reported 6-month analyses.
CONCLUSIONS


After ≥2 years of follow-up, avelumab showed prolonged efficacy and acceptable safety in patients with platinum-treated advanced/metastatic urothelial carcinoma, including high-risk subgroups. Survival appeared longer in patients who responded within 3 months. Long-term safety findings were consistent with earlier reports with avelumab treatment in this patient population.",2020,Objective response achieved by 3 months versus later was associated with longer OS (median not reached (95% CI 18.9 months to not estimable) vs 7.1 months (95% CI 5.2 to 9.0 months)).,"['242 postplatinum patients', 'Patients with previously treated advanced/metastatic urothelial carcinoma', 'patients with platinum-treated advanced/metastatic urothelial carcinoma, including high-risk subgroups', 'patients with urothelial carcinoma']",[],"['Objective response', 'avelumab; efficacy', 'antitumor activity', 'prolonged efficacy and acceptable safety', 'Median PFS', 'confirmed ORR', 'objective response rates (ORRs', 'Survival', 'overall response and progression-free survival (PFS) per RECIST V.1.1, overall survival (OS) and safety', 'longer OS', 'Median OS', 'Median duration of response', '12-month PFS rate', '24-month OS rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}]",[],"[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",242.0,0.186069,Objective response achieved by 3 months versus later was associated with longer OS (median not reached (95% CI 18.9 months to not estimable) vs 7.1 months (95% CI 5.2 to 9.0 months)).,"[{'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Apolo', 'Affiliation': 'Hematology Oncology, Oregon Health & Science University, Portland, Oregon, USA andrea.apolo@nih.gov.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ellerton', 'Affiliation': 'Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Infante', 'Affiliation': 'Nevada Cancer Research Foundation, Las Vegas, Nevada, USA.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Agrawal', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, Tennessee, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Gordon', 'Affiliation': 'Associates in Oncology, Rockville, Maryland, USA.'}, {'ForeName': 'Raid', 'Initials': 'R', 'LastName': 'Aljumaily', 'Affiliation': 'Nevada Cancer Research Foundation, Las Vegas, Nevada, USA.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Gourdin', 'Affiliation': 'Hematology/Oncology, The University of Oklahoma Stephenson Cancer Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Dirix', 'Affiliation': 'Department of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Keun-Wook', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Medical Oncology, Sint-Augustinus Hospital Oncology Centre, Antwerp, Belgium.'}, {'ForeName': 'Matthew H', 'Initials': 'MH', 'LastName': 'Taylor', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Henry Ford Cancer Institute, Detroit, Michigan, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'Department of Medical Oncology, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Manitz', 'Affiliation': 'EMD Serono Research & Development Institute, Inc, Billerica, Massachusetts, USA; a business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Pennock', 'Affiliation': 'EMD Serono, Inc, Rockland, Massachusetts, USA; a business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ruisi', 'Affiliation': 'EMD Serono Research & Development Institute, Inc, Billerica, Massachusetts, USA; a business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Gulley', 'Affiliation': 'Hematology Oncology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Manish R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, Florida, USA.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-001246']
2163,33038066,A high salt meal does not impair cerebrovascular reactivity in healthy young adults.,"A high sodium (Na +  ) meal impairs peripheral vascular function. In rodents, chronic high dietary Na +  impairs cerebral vascular function, and in humans, habitual high dietary Na +  is associated with increased stroke risk. However, the effects of acute high dietary Na +  on the cerebral vasculature in humans are unknown. The purpose of this study was to determine if acute high dietary Na +  impairs cerebrovascular reactivity in healthy adults. Thirty-seven participants (20F/17M; 25 ± 5 years; blood pressure [BP]: 107 ± 9/61 ± 6 mm Hg) participated in this randomized, cross-over study. Participants were given a low Na +  meal (LSM; 138 mg Na +  ) and a high Na +  meal (HSM; 1,495 mg Na +  ) separated by ≥ one week. Serum Na +  , beat-to-beat BP, middle cerebral artery velocity (transcranial Doppler), and end-tidal carbon dioxide (P ET  CO 2  ) were measured pre- (baseline) and 60 min post-prandial. Cerebrovascular reactivity was assessed by determining the percent change in middle cerebral artery velocity to hypercapnia (via 8% CO 2  , 21% oxygen, balance nitrogen) and hypocapnia (via mild hyperventilation). Peripheral vascular function was measured using brachial artery flow-mediated dilation (FMD). Changes in serum Na +  were greater following the HSM (HSM: Δ1.6 ± 1.2 mmol/L vs. LSM: Δ0.7 ± 1.2 mmol/L, p < .01). Cerebrovascular reactivity to hypercapnia (meal effect: p = .41) and to hypocapnia (meal effect: p = .65) were not affected by the HSM. Contrary with previous findings, FMD was not reduced following the HSM (meal effect: p = .74). These data suggest that a single high Na +  meal does not acutely impair cerebrovascular reactivity, and suggests that despite prior findings, a single high Na +  meal does not impair peripheral vascular function in healthy adults.",2020,"Contrary with previous findings, FMD was not reduced following the HSM (meal effect: p = .74).","['healthy young adults', 'Thirty-seven participants (20F/17M; 25\xa0±\xa05\xa0years; blood pressure [BP]: 107\xa0±\xa09/61\xa0±\xa06\xa0mm\xa0Hg', 'healthy adults']","['high Na +  meal (HSM; 1,495\xa0mg Na +  ) separated by\xa0≥\xa0one week', 'sodium (Na +  ) meal', 'dietary Na ', 'low Na +  meal (LSM; 138']","['Serum Na +  , beat-to-beat BP, middle cerebral artery velocity (transcranial Doppler), and end-tidal carbon dioxide (P ET  CO 2  ', 'Cerebrovascular reactivity to hypercapnia', 'Peripheral vascular function', 'brachial artery flow-mediated dilation (FMD', 'middle cerebral artery velocity to hypercapnia', 'cerebrovascular reactivity', 'Cerebrovascular reactivity', 'Changes in serum Na ', 'peripheral vascular function']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0206077', 'cui_str': 'Transcranial doppler ultrasonography'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",37.0,0.0392972,"Contrary with previous findings, FMD was not reduced following the HSM (meal effect: p = .74).","[{'ForeName': 'Kamila U', 'Initials': 'KU', 'LastName': 'Migdal', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Austin T', 'Initials': 'AT', 'LastName': 'Robinson', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Babcock', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Lennon', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Martens', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Jorge M', 'Initials': 'JM', 'LastName': 'Serrador', 'Affiliation': 'Department of Pharmacology, Physiology & Neuroscience, Rutgers New Jersey Medical School, Newark, NJ, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}]",Physiological reports,['10.14814/phy2.14585']
2164,33034983,Global and Regional Respiratory Mechanics During Robotic-Assisted Laparoscopic Surgery: A Randomized Study: Erratum.,,2020,,[],['Robotic-Assisted Laparoscopic Surgery'],[],[],"[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]",[],,0.164693,,[],Anesthesia and analgesia,['10.1213/ANE.0000000000004640']
2165,33035274,"Programmatic evaluation of feasibility and efficiency of at birth and 6-week, point of care HIV testing in Kenyan infant.","BACKGROUND


Testing infants at birth and with more efficient point of care (POC) HIV diagnostic can streamline EID and expedite infant ART initiation. We evaluated the implementation of at birth and 6-week POC testing to assess the effectiveness and feasibility when implemented by existing hospital staff in Kenya.
METHODS


Four government hospitals were randomly assigned to receive a GeneXpert HIV-1 Qual (n = 2) or Alere m-PIMA (n = 2) machine for POC testing. All HIV-exposed infants enrolled were eligible to receive POC testing at birth and 6-weeks of age. The primary outcome was repeat POC testing, defined as testing both at birth and 6-weeks of age. Secondary outcomes included predictors of repeat POC testing, POC efficiency (turnaround times of key services), and operations (failed POC results, missed opportunities).
RESULTS


Of 626 enrolled infants, 309 (49.4%) received repeat POC testing, 115 (18.4%) were lost to follow up after an at-birth test, 120 (19.2%) received POC testing at 6-weeks only, 80 (12.8%) received no POC testing, and 2 (0.3%) received delayed POC testing (>12 weeks of age). Three (0.4%) were identified as HIV-positive. Of the total 853 POC tests run at birth (n = 424) or 6-weeks (n = 429), 806 (94.5%) had a valid result documented and 792 (98.3%) results had documented maternal notification. Mean time from sample collection to notification was 1.08 days, with 751 (94.8%) notifications on the same day as sample collection. Machine error rates at birth and 6-weeks were 8.5% and 2.5%, respectively. A total of 198 infants presented for care (48 at birth; 150 at 6-weeks) without receiving a POC test, representing missed opportunities for testing.
DISCUSSION


At birth POC testing can streamline infant HIV diagnosis, expedite ART initiation and can be implemented by existing hospital staff. However, maternal disengagement and missed opportunities for testing must be addressed to realize the full benefits of at birth POC testing.",2020,"At birth POC testing can streamline infant HIV diagnosis, expedite ART initiation and can be implemented by existing hospital staff.","['Four government hospitals', 'Kenyan infant', 'All HIV-exposed infants enrolled were eligible to receive POC testing at birth and 6-weeks of age', '626 enrolled infants, 309 (49.4%) received', '198 infants presented for care (48 at birth; 150 at 6-weeks) without receiving a POC test, representing missed opportunities for testing']","['GeneXpert HIV-1 Qual (n = 2) or Alere m-PIMA (n = 2) machine for POC testing', 'delayed POC testing']","['Machine error rates', 'maternal notification', 'repeat POC testing', 'repeat POC testing, defined as testing both at birth and 6-weeks of age', 'Mean time', 'POC testing', 'repeat POC testing, POC efficiency (turnaround times of key services), and operations (failed POC results, missed opportunities']","[{'cui': 'C0337960', 'cui_str': 'Government hospital'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C2924612', 'cui_str': 'Cephalometric point A'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0722638', 'cui_str': 'Pima brand of potassium iodide'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",626.0,0.0931997,"At birth POC testing can streamline infant HIV diagnosis, expedite ART initiation and can be implemented by existing hospital staff.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Wexler', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Niaman', 'Initials': 'N', 'LastName': 'Nazir', 'Affiliation': 'Department of Preventive Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Maloba', 'Affiliation': 'Global Health Innovations-Kenya, Nairobi, Kenya.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Children's Mercy Kansas City, Health Services and Outcomes Research, Kansas City, MO, United States of America.""}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Gautney', 'Affiliation': 'Global Health Innovations, Dallas, TX, United States of America.'}, {'ForeName': 'Nicodemus', 'Initials': 'N', 'LastName': 'Maosa', 'Affiliation': 'Global Health Innovations-Kenya, Nairobi, Kenya.'}, {'ForeName': 'Shadrack', 'Initials': 'S', 'LastName': 'Babu', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Muchoki', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Natabhona', 'Initials': 'N', 'LastName': 'Mabachi', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Lwembe', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Finocchario-Kessler', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}]",PloS one,['10.1371/journal.pone.0240621']
2166,33035416,[The role of sleep in the relational memory processes].,"Background and purpose


A growing body of evidence suggests that sleep plays an essential role in the consolidation of different memory systems, but less is known about the beneficial effect of sleep on relational memory processes and the recognition of emotional facial expressions, however, it is a fundamental cognitive skill in human everyday life. Thus, the study aims to investigate the effect of timing of learning and the role of sleep in relational memory processes.
Methods


84 young adults (average age: 22.36 (SD: 3.22), 21 male/63 female) participated in our study, divided into two groups: evening group and morning group indicating the time of learning. We used the face-name task to measure relational memory and facial expression recognition. There were two sessions for both groups: the immediate testing phase and the delayed retesting phase, separated by 24 hours.
Results


84 young adults (average age: 22.36 (SD: 3.22), 21 male/63 female) participated in our study, divided into two groups: evening group and morning group indicating the time of learning. We used the face-name task to measure relational memory and facial expression recognition. There were two sessions for both groups: the immediate testing phase and the delayed retesting phase, separated by 24 hours.
Conclusion


Our results suggest that the timing of learning and sleep plays an important role in the stabilizing process of memory representation to resist against forgetting.",2020,"There were two sessions for both groups: the immediate testing phase and the delayed retesting phase, separated by 24 hours.
","['84 young adults (average age: 22.36 (SD: 3.22), 21 male/63 female']",['evening group and morning group indicating the time of learning'],['relational memory and facial expression recognition'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",84.0,0.0199132,"There were two sessions for both groups: the immediate testing phase and the delayed retesting phase, separated by 24 hours.
","[{'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Csábi', 'Affiliation': 'Szegedi Tudományegyetem, Pszichológia Intézet, Kognitív és Neuropszichológia Tanszék, Szeged.'}, {'ForeName': 'Ágnes', 'Initials': 'Á', 'LastName': 'Zámbó', 'Affiliation': 'Szegedi Tudományegyetem, Pszichológia Intézet, Kognitív és Neuropszichológia Tanszék, Szeged.'}, {'ForeName': 'Lídia', 'Initials': 'L', 'LastName': 'Prokecz', 'Affiliation': 'Szegedi Tudományegyetem, Pszichológia Intézet, Kognitív és Neuropszichológia Tanszék, Szeged.'}]",Ideggyogyaszati szemle,['10.18071/isz.73.0327']
2167,33035492,Is Preoperative Administration of Tranexamic Acid Effective on Blood Loss Reduction in Mandibular Fracture Surgeries? A Triple-Blind Randomized Clinical Trial.,"PURPOSE


Hemorrhage is one of the significant factors that cause adverse reactions and complications during trauma management. This study aimed to investigate the effectiveness of preoperative tranexamic acid (TXA) administration on intraoperative blood loss in mandibular fracture surgeries.
MATERIALS AND METHODS


The authors implemented a triple blinded randomized clinical trial. All healthy young patients who suffered from bilateral displaced mandibular angle and body fractures were included in this study. All operations were performed using open reduction and internal fixation by the same surgical team. The eligible subjects were randomly divided into 2 equal groups. The anesthesiology staff administered the intravenous TXA (20 mg/kg) to the intervention group and 20 mL of intravenous normal saline (0.09%) in the control group, 30 minutes preoperatively. The study outcome variables included intraoperative blood loss and hemoglobin loss. The data were statistically analyzed in SPSS, version 20 (SPSS Inc, Chicago, IL).
RESULTS


Fifty patients, including 31 males (62%) and 19 females (38%), with the mean age of 28 ± 5.6 years were studied. The mean blood loss was 360.57 ± 173.5 mL and 560.9 ± 248.07 mL in the TXA and control groups, respectively. This difference was statistically significant (P = .008). In addition, the mean drop in hemoglobin value was 0.91 ± 0.33 mg/dL in the intervention group and 1.44 ± 0.45 mg/dL in the control group, with a significant difference (P = .001). No adverse effect was observed in the TXA cases.
CONCLUSIONS


TXA is a safe and effective drug for reducing intraoperative blood loss in patients who underwent mandibular fracture open reduction and internal fixation surgeries.",2020,"CONCLUSIONS


TXA is a safe and effective drug for reducing intraoperative blood loss in patients who underwent mandibular fracture open reduction and internal fixation surgeries.","['All healthy young patients who suffered from the bilateral displaced mandibular angle and body fractures', 'mandibular fracture surgeries', 'patients who underwent mandibular fracture open reduction and internal fixation surgeries', 'Fifty patients, including 31 males (62%) and 19 females (38%), with the mean age of 28\xa0±\xa05.6 years were studied', 'Mandibular Fractures Surgeries']","['Tranexamic Acid', 'preoperative tranexamic acid (TXA', 'TXA', 'intravenous normal saline']","['adverse effect', 'intraoperative blood loss', 'intraoperative blood loss and hemoglobin loss', 'mean blood loss', 'mean drop in hemoglobin value', 'SPSS, version 20 (SPSS Inc, Chicago, IL']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0024692', 'cui_str': 'Fracture of mandible'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}]",,0.0519843,"CONCLUSIONS


TXA is a safe and effective drug for reducing intraoperative blood loss in patients who underwent mandibular fracture open reduction and internal fixation surgeries.","[{'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Khiabani', 'Affiliation': 'Associate Professor, Department of Oral & Maxillofacial Surgery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ahmadfar', 'Affiliation': 'Oral & Maxillofacial Surgeon, Private Practice, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Labafchi', 'Affiliation': 'Dentist, Student Research Committee, Faculty of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Gosheh', 'Affiliation': 'Assistant Professor, Department of Anesthesiology, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Sahand', 'Initials': 'S', 'LastName': 'Samieirad', 'Affiliation': 'Associate Professor, Oral and Maxillofacial Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: samieerads@mums.ac.ir.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.09.011']
2168,33036174,PromarkerD Predicts Renal Function Decline in Type 2 Diabetes in the Canagliflozin Cardiovascular Assessment Study (CANVAS).,"The ability of current tests to predict chronic kidney disease (CKD) complicating diabetes is limited. This study investigated the prognostic utility of a novel blood test, PromarkerD, for predicting future renal function decline in individuals with type 2 diabetes from the CANagliflozin CardioVascular Assessment Study (CANVAS). PromarkerD scores were measured at baseline in 3568 CANVAS participants ( n  = 1195 placebo arm,  n  = 2373 canagliflozin arm) and used to predict incident CKD (estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m 2  during follow-up in those above this threshold at baseline) and eGFR decline ≥30% during the 4 years from randomization. Biomarker concentrations (apolipoprotein A-IV (apoA4), CD5 antigen-like (CD5L/AIM) and insulin-like growth factor-binding protein 3 (IGFBP3) measured by mass spectrometry were combined with clinical data (age, serum high-density lipoprotein (HDL)-cholesterol, eGFR) using a previously defined algorithm to provide PromarkerD scores categorized as low-, moderate- or high-risk. The participants (mean age 63 years, 33% females) had a median PromarkerD score of 2.9%, with 70.5% categorized as low-risk, 13.6% as moderate-risk and 15.9% as high-risk for developing incident CKD. After adjusting for treatment, baseline PromarkerD moderate-risk and high-risk scores were increasingly prognostic for incident CKD (odds ratio 5.29 and 13.52 versus low-risk, respectively; both  p  < 0.001). Analysis of the PromarkerD test system in CANVAS shows the test can predict clinically significant incident CKD in this multi-center clinical study but had limited utility for predicting eGFR decline ≥30%.",2020,Analysis of the PromarkerD test system in CANVAS shows the test can predict clinically significant incident CKD in this multi-center clinical study but had limited utility for predicting eGFR decline ≥30%.,['individuals with type 2 diabetes from the CANagliflozin CardioVascular Assessment Study (CANVAS'],[],"['Biomarker concentrations (apolipoprotein A-IV (apoA4), CD5 antigen-like (CD5L/AIM) and insulin-like growth factor-binding protein 3 (IGFBP3', 'PromarkerD scores', 'median PromarkerD score', 'baseline PromarkerD moderate-risk and high-risk scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0052181', 'cui_str': 'Apolipoprotein A-IV'}, {'cui': 'C1528456', 'cui_str': 'CD5L protein, human'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0123707', 'cui_str': 'Insulin-like growth factor binding protein 3'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]",3568.0,0.046152,Analysis of the PromarkerD test system in CANVAS shows the test can predict clinically significant incident CKD in this multi-center clinical study but had limited utility for predicting eGFR decline ≥30%.,"[{'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Peters', 'Affiliation': 'Proteomics International, Nedlands, WA 6009, Australia.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, PA 19477, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Bringans', 'Affiliation': 'Proteomics International, Nedlands, WA 6009, Australia.'}, {'ForeName': 'Wendy A', 'Initials': 'WA', 'LastName': 'Davis', 'Affiliation': 'Medical School, The University of Western Australia, Fremantle Hospital, Fremantle, WA 6959, Australia.'}, {'ForeName': 'Timothy M E', 'Initials': 'TME', 'LastName': 'Davis', 'Affiliation': 'Medical School, The University of Western Australia, Fremantle Hospital, Fremantle, WA 6959, Australia.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Hansen', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, PA 19477, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Lipscombe', 'Affiliation': 'Proteomics International, Nedlands, WA 6009, Australia.'}]",Journal of clinical medicine,['10.3390/jcm9103212']
2169,33036179,"One Year's Treatment with the Glucagon-Like Peptide 1 Receptor Agonist Liraglutide Decreases Hepatic Fat Content in Women with Nonalcoholic Fatty Liver Disease and Prior Gestational Diabetes Mellitus in a Randomized, Placebo-Controlled Trial.","Prior gestational diabetes mellitus (pGDM) is associated with increased risk of nonalcoholic fatty liver disease (NAFLD). Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists has shown beneficial effects in NAFLD patients. We evaluated the effect of the GLP-1 analogue liraglutide on NAFLD features in women with pGDM. Eighty-two overweight/obese, nondiabetic women with pGDM were included. We performed abdominal ultrasound, transient elastography with controlled attenuation parameter (CAP), and blood sampling at baseline and after 1 year. Thirty-seven women were randomized to liraglutide (1.8 mg once-daily) and 45 to placebo. Based on the ultrasound scan, 18 women (22%) had ultrasound-verified NAFLD at baseline and of these, 10 (56%) received liraglutide treatment. After 1 year, eight participants no longer had steatosis, four in each treatment group. The number of participants who developed NAFLD was similar in the two treatment groups; five in the liraglutide group and six in the placebo group ( p  = 0.74). Compared to placebo, liraglutide reduced the CAP-assessed intrahepatic fat content (-28 (-44;-11) vs. 2 (-13;18) dB/m,  p <  0.01) and body weight (-4.7 (-6.4;-2.9) vs. -1.4 (-3;0.3) kg,  p <  0.01). One-year's liraglutide treatment had no effect on the presence of ultrasound-diagnosed NAFLD in overweight/obese nondiabetic women with pGDM, but reduced body weight and steatosis assessed by transient elastography with CAP.",2020,The number of participants who developed NAFLD was similar in the two treatment groups; five in the liraglutide group and six in the placebo group ( p  = 0.74).,"['Thirty-seven women', 'Women with Nonalcoholic Fatty Liver Disease and Prior Gestational Diabetes Mellitus', 'Prior gestational diabetes mellitus (pGDM', 'women with pGDM', 'Eighty-two overweight/obese, nondiabetic women with pGDM were included', 'NAFLD patients']","['liraglutide treatment', 'liraglutide', 'glucagon-like peptide 1 (GLP-1) receptor agonists', 'placebo, liraglutide', 'Glucagon-Like Peptide 1 Receptor Agonist Liraglutide', 'placebo', 'GLP-1 analogue liraglutide', 'Placebo']","['presence of ultrasound-diagnosed NAFLD', 'NAFLD features', 'body weight', 'CAP-assessed intrahepatic fat content', 'NAFLD', 'body weight and steatosis']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}]",82.0,0.352378,The number of participants who developed NAFLD was similar in the two treatment groups; five in the liraglutide group and six in the placebo group ( p  = 0.74).,"[{'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Vedtofte', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Bahne', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Foghsgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Jonatan I', 'Initials': 'JI', 'LastName': 'Bagger', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Andreasen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Strandberg', 'Affiliation': 'Department of Radiology, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 4A, 2900 Hellerup, Denmark.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Gørtz', 'Affiliation': 'Department of Nuclear Medicine, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 2, 1st floor, 2900 Hellerup, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Grønbæk', 'Affiliation': 'Department of Hepatology & Gastroenterology, Aarhus University Hospital, University of Aarhus, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Jens A', 'Initials': 'JA', 'LastName': 'Svare', 'Affiliation': 'Department of Obstetrics and Gynaecology, Herlev Hospital, University of Copenhagen, Borgmester Ib Juuls Vej 21, 2730 Herlev, Denmark.'}, {'ForeName': 'Tine D', 'Initials': 'TD', 'LastName': 'Clausen', 'Affiliation': 'Department of Gynaecology and Obstetrics, Nordsjaellands Hospital, University of Copenhagen, Dyrehavevej 29, 3400 Hillerød, Denmark.'}, {'ForeName': 'Elisabeth R', 'Initials': 'ER', 'LastName': 'Mathiesen', 'Affiliation': 'Center for Pregnant Women with Diabetes, Department of Endocrinology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Damm', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Lise L', 'Initials': 'LL', 'LastName': 'Gluud', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}]",Journal of clinical medicine,['10.3390/jcm9103213']
2170,33036201,A Partially Hydrolyzed Whey Infant Formula Supports Appropriate Growth: A Randomized Controlled Non-Inferiority Trial.,"The aim of the current study was to investigate the effects of a partially hydrolyzed whey infant formula (PHF) on growth in healthy term infants as compared to a standard infant formula with intact protein (IPF). In a double-blind, non-inferiority, randomized controlled trial, a total of 163 healthy formula-fed infants, 55-80 days old, were recruited and randomly allocated to either the PHF (test) or the IPF (control) group. They were followed up for three months during which they were evaluated monthly on growth and development. In total, 21 infants discontinued the study, while 142 infants completed the study (test  n  = 72, control  n  = 70). The primary outcome was daily weight gain during the three months. Secondary outcomes included additional anthropometric indices at every timepoint over the intervention period. Daily weight gain during the three-month intervention period was similar in both groups with the lower bound of 95% confidence interval (CI) above the non-inferiority margin of -3 g/day [mean difference (95% CI) test vs. control: -0.474 (-2.460, 1.512) g/day]. Regarding secondary outcomes, i.e., infants' weight, length, head circumference, body mass index (BMI), and their Z-scores, no differences were observed between the two groups at any time point. The PHF resulted in similar infant growth outcomes as the standard IPF. Based on these results, it can be concluded that the partially hydrolyzed whey infant formula supports adequate growth in healthy term infants.",2020,"Daily weight gain during the three-month intervention period was similar in both groups with the lower bound of 95% confidence interval (CI) above the non-inferiority margin of -3 g/day [mean difference (95% CI) test vs. control: -0.474 (-2.460, 1.512) g/day].","['163 healthy formula-fed infants, 55-80 days old', 'healthy term infants', '21 infants discontinued the study, while 142 infants completed the study (test  n  = 72, control  n  = 70']","['PHF (test) or the IPF (control) group', 'standard infant formula with intact protein (IPF', 'partially hydrolyzed whey infant formula (PHF']","['daily weight gain', ""infants' weight, length, head circumference, body mass index (BMI), and their Z-scores"", 'Daily weight gain', 'additional anthropometric indices at every timepoint']","[{'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3853282', 'cui_str': 'Standard infant formula'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",163.0,0.293575,"Daily weight gain during the three-month intervention period was similar in both groups with the lower bound of 95% confidence interval (CI) above the non-inferiority margin of -3 g/day [mean difference (95% CI) test vs. control: -0.474 (-2.460, 1.512) g/day].","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Karaglani', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 70 El. Venizelou Ave, 17671 Athens, Greece.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Thijs-Verhoeven', 'Affiliation': 'FrieslandCampina, Stationsplein 1, 3818 LE Amersfoort, The Netherlands.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Gros', 'Affiliation': 'FrieslandCampina, Stationsplein 1, 3818 LE Amersfoort, The Netherlands.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Chairistanidou', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 70 El. Venizelou Ave, 17671 Athens, Greece.'}, {'ForeName': 'Giorgos', 'Initials': 'G', 'LastName': 'Zervas', 'Affiliation': 'Mitera hospital, 6 Erythrou Stavrou Str., 151 23 Athens, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Filoilia', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 70 El. Venizelou Ave, 17671 Athens, Greece.'}, {'ForeName': 'Tarek-Michail', 'Initials': 'TM', 'LastName': 'Kampani', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 70 El. Venizelou Ave, 17671 Athens, Greece.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Miligkos', 'Affiliation': 'Mitera hospital, 6 Erythrou Stavrou Str., 151 23 Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Matiatou', 'Affiliation': 'Mitera hospital, 6 Erythrou Stavrou Str., 151 23 Athens, Greece.'}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Valaveri', 'Affiliation': 'Mitera hospital, 6 Erythrou Stavrou Str., 151 23 Athens, Greece.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Sakellariou', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 70 El. Venizelou Ave, 17671 Athens, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Babilis', 'Affiliation': 'Mitera hospital, 6 Erythrou Stavrou Str., 151 23 Athens, Greece.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Bos', 'Affiliation': 'FrieslandCampina, Stationsplein 1, 3818 LE Amersfoort, The Netherlands.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 70 El. Venizelou Ave, 17671 Athens, Greece.'}]",Nutrients,['10.3390/nu12103056']
2171,33036224,Vitamin K Intake in Chronic Stroke: Implications for Dietary Recommendations.,"Previous research has identified a possible association between vitamin K intake and cardiometabolic disease. This could mean that the assessment of vitamin K intake is a meaningful tool when monitoring individuals with preexisting cardiovascular disease. Sixty chronic stroke survivors (men and women, body mass index (BMI) 30.36 ± 6.61 kg/m 2 , age 61.7 ± 7.2 years) completed food records which were analyzed for energy, macronutrient, micronutrient, and food group servings. Participants were divided into two groups: below vitamin K recommendation (BEL,  n  = 49) and met vitamin K recommendation (MET,  n  = 11). Energy and macronutrient intake did not differ between groups (all  p  > 0.127). Vegetable intake was higher in the MET group ( p  = 0.0001). Vitamin K intake was higher in the MET group ( p  = 0.0001). Calcium ( p  = 0.003), vitamin A ( p  = 0.007), and vitamin E ( p  = 0.005) intakes were higher in the MET group. There were no differences in sodium, potassium, vitamin D, vitamin C, and iron intakes between groups (all  p  > 0.212). In this sample of chronic stroke survivors, 82% reported consuming below the Dietary Reference Intake (DRI) for vitamin K. Given that the majority of this study population did not reach the DRI for vitamin K, it is advisable to promote the adequate intake of food rich in vitamin K. Further work is needed to determine the significance of low vitamin K intake in this population.",2020,Vegetable intake was higher in the MET group ( p  = 0.0001).,"['Sixty chronic stroke survivors (men and women, body mass index (BMI) 30.36 ± 6.61 kg/m 2 , age 61.7 ± 7.2 years) completed food records which were analyzed for energy, macronutrient, micronutrient, and food group servings', 'individuals with preexisting cardiovascular disease', 'Chronic Stroke']","['vitamin K intake', 'below vitamin K recommendation (BEL,  n  = 49) and met vitamin K recommendation', 'Vitamin K Intake']","['Vegetable intake', 'Vitamin K intake', 'vitamin E', 'Energy and macronutrient intake', 'sodium, potassium, vitamin D, vitamin C, and iron intakes']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C2317598', 'cui_str': 'Vitamin K intake'}, {'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}]","[{'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C2317598', 'cui_str': 'Vitamin K intake'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0518043', 'cui_str': 'Iron intake'}]",,0.0550242,Vegetable intake was higher in the MET group ( p  = 0.0001).,"[{'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Wessinger', 'Affiliation': 'VA Research Service, Department of Medicine, Division of Gerontology and Geriatric Medicine at the University of Maryland School of Medicine, and the Baltimore VA Medical Center Geriatric Research, Education and Clinical Center (GRECC), VA Maryland Health Care System, Baltimore, MD 21201, USA.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Hafer-Macko', 'Affiliation': 'VA Research Service, Department of Medicine, Division of Gerontology and Geriatric Medicine at the University of Maryland School of Medicine, and the Baltimore VA Medical Center Geriatric Research, Education and Clinical Center (GRECC), VA Maryland Health Care System, Baltimore, MD 21201, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'S Ryan', 'Affiliation': 'VA Research Service, Department of Medicine, Division of Gerontology and Geriatric Medicine at the University of Maryland School of Medicine, and the Baltimore VA Medical Center Geriatric Research, Education and Clinical Center (GRECC), VA Maryland Health Care System, Baltimore, MD 21201, USA.'}]",Nutrients,['10.3390/nu12103059']
2172,33036537,[Effects of transcranial direct current stimulation on cognitive function in delayed encephalopathy after carbon monoxide poisoning].,"Objective:  To investigate the effect of transcranial direct current stimulation (tDCS) on cognitive function of delayed encephalopathy after carbon monoxide poisoning (DEACMP) .  Methods:  A total of 58 patients with DEACMP admitted to the Emergency Medicine Department of Hudson International Peace Hospital from January 2018 to January 2020 were included. According to the random number table, the patients were randomly divided into study group and control group, with 29 patients in each group. Patients in both groups were given nutritional nerve therapy, improved microcirculation, adrenal cortical hormone and other drugs, as well as hyperbaric oxygen and rehabilitation training, once per day. The study group was treated with tDCS (electrode pads were placed and current stimulation was given 30 min/time) 1/d on the basis of conventional treatment, while the control group was treated with tDCS pseudo stimulation (electrode pads were placed and current stimulation was given for 10 s) 1/d for 30 days consecutively. The auditory event-related potential P300 (ERP-P300) was tested before and 30 days after treatment, and the Mini-Mental State Examination (MMSE) scale, Barthel index (BI) and the National Institutes of Health Neurological Impairment score (NIHSS) were used to evaluate and analyze the patients.  Results:  There was no significant difference in scores between the two groups before treatment (all  P >0.05) . After 30 days of treatment, the MMSE score, orientation, memory, attention and computing power, and language ability of the study group were all higher than those of the control group, and the differences were statistically significant ( P <0.05) . 90 days after treatment, the BI of the study group was higher than that of the control group ( P <0.05) . After 30 days of treatment, the NIHSS score of the study group was significantly lower than that of the control group ( P <0.05) . The latency of ERP-P300 in the study group was shorter than that in the control group, and the amplitude was higher than that in the control group at 30 days after treatment, and the difference was statistically significant ( P <0.05) . The latency of ERP-P300 was negatively correlated with the total MMSE score before and after DEACMP treatment ( r =-0.837, -0.819,  P <0.05) . The latency of ERP-P300 was negatively correlated with orientation, attention and computing power, and language ability before treatment ( r =-0.698, -0.675, -0.742,  P <0.05) .  Conclusion:  TDCS treatment can help improve the cognitive function of DEACMP patients, and ERP-P300 test can help determine the cognitive function severity of patients.",2020,"The latency of ERP-P300 was negatively correlated with orientation, attention and computing power, and language ability before treatment ( r =-0.698, -0.675, -0.742,  P <0.05) .  ","['delayed encephalopathy after carbon monoxide poisoning', '58 patients with DEACMP admitted to the Emergency Medicine Department of Hudson International Peace Hospital from January 2018 to January 2020 were included', 'delayed encephalopathy after carbon monoxide poisoning (DEACMP) ']","['nutritional nerve therapy, improved microcirculation, adrenal cortical hormone and other drugs, as well as hyperbaric oxygen and rehabilitation training', 'TDCS', 'tDCS (electrode pads were placed and current stimulation was given 30 min/time', 'tDCS pseudo stimulation (electrode pads were placed and current stimulation', 'transcranial direct current stimulation', 'transcranial direct current stimulation (tDCS']","['latency of ERP-P300', 'NIHSS score', 'Mini-Mental State Examination (MMSE) scale, Barthel index (BI) and the National Institutes of Health Neurological Impairment score (NIHSS', 'cognitive function', 'orientation, attention and computing power, and language ability', 'auditory event-related potential P300 (ERP-P300', 'MMSE score, orientation, memory, attention and computing power, and language ability', 'total MMSE score']","[{'cui': 'C0085584', 'cui_str': 'Encephalopathy'}, {'cui': 'C0007020', 'cui_str': 'Carbon monoxide poisoning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C0271276', 'cui_str': ""Stahli's line""}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205237', 'cui_str': 'False'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0015214', 'cui_str': 'Evoked potential'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",58.0,0.0255641,"The latency of ERP-P300 was negatively correlated with orientation, attention and computing power, and language ability before treatment ( r =-0.698, -0.675, -0.742,  P <0.05) .  ","[{'ForeName': 'S Q', 'Initials': 'SQ', 'LastName': 'Cao', 'Affiliation': 'Department of Emergency Medicine, Hudson International Peace Hospital, Hebei Medical University, Hengshui 053000, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Emergency Medicine, Hudson International Peace Hospital, Hebei Medical University, Hengshui 053000, China.'}, {'ForeName': 'B Y', 'Initials': 'BY', 'LastName': 'Zhu', 'Affiliation': 'Department of Emergency Medicine, Hudson International Peace Hospital, Hebei Medical University, Hengshui 053000, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Emergency Medicine, Hudson International Peace Hospital, Hebei Medical University, Hengshui 053000, China.'}, {'ForeName': 'Y J', 'Initials': 'YJ', 'LastName': 'Liu', 'Affiliation': 'Department of Emergency Medicine, Hudson International Peace Hospital, Hebei Medical University, Hengshui 053000, China.'}, {'ForeName': 'Q M', 'Initials': 'QM', 'LastName': 'Xiao', 'Affiliation': 'Department of Emergency Medicine, Hudson International Peace Hospital, Hebei Medical University, Hengshui 053000, China.'}, {'ForeName': 'W Z', 'Initials': 'WZ', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency Medicine, Hudson International Peace Hospital, Hebei Medical University, Hengshui 053000, China.'}, {'ForeName': 'Y X', 'Initials': 'YX', 'LastName': 'Du', 'Affiliation': 'Department of Emergency Medicine, Hudson International Peace Hospital, Hebei Medical University, Hengshui 053000, China.'}]",Zhonghua lao dong wei sheng zhi ye bing za zhi = Zhonghua laodong weisheng zhiyebing zazhi = Chinese journal of industrial hygiene and occupational diseases,['10.3760/cma.j.cn121094-20200224-00085']
2173,33036554,"Continuous block at the proximal end of the adductor canal provides better analgesia compared to that at the middle of the canal after total knee arthroplasty: a randomized, double-blind, controlled trial.","BACKGROUND


The optimal position for continuous adductor canal block (ACB) for analgesia after total knee anthroplasty (TKA) remians controversial, mainly due to high variability in the localization of the the adductor canal (AC). Latest neuroanatomy studies show that the nerve to vastus medialis plays an important role in innervating the anteromedial aspect of the knee and dives outside of the exact AC at the proximal end of the AC. Therefore, we hypothesized that continuous ACB at the proximal end of the exact AC could provide a better analgesic effect after TKA compared with that at the middle of the AC (which appeared to only block the saphenous nerve).
METHODS


Sixty-two adult patients who were scheduled for a unilateral TKA were randomized to receive continuous ACB at the proximal end or middle of the AC. All patients received patient-controlled intravenous analgesia with sufentanil postoperatively. The primary outcome measure was cumulative sufentanil consumption within 24 h after the surgery, which was analyzed using Mann-Whitney U tests. P-values < 0.05 (two-sided) were considered statistically significant. The secondary outcomes included postoperative sufentanil consumption at other time points, pain at rest and during passive knee flexion, quadriceps motor strength, and other recovery related paramaters.
RESULTS


Sixty patients eventually completed the study (30/group). The 24-h sufentanil consumption was 0.22 μg/kg (interquartile range [IQR]: 0.15-0.40 μg/kg) and 0.39 μg/kg (IQR: 0.23-0.52 μg/kg) in the proximal end and middle groups (P = 0.026), respectively. There were no significant inter-group differences in sufentanil consumption at other time points, pain at rest and during passive knee flexion, quadriceps motor strength, and other recovery related paramaters.
CONCLUSIONS


Continuous ACB at the proximal end of the AC has a better opioid-sparing effect without a significant influence on quadriceps motor strength compared to that at the middle of the AC after TKA. These findings indicates that a true ACB may not produce the effective analgesia, instead, the proximal end AC might be a more suitable block to alleviate pain after TKA.
TRIAL REGISTRATION


This study was registered at ClinicalTrials.gov ( NCT03942133 ; registration date: May 06, 2019; enrollment date: May 11, 2019).",2020,"There were no significant inter-group differences in sufentanil consumption at other time points, pain at rest and during passive knee flexion, quadriceps motor strength, and other recovery related paramaters.
","['Sixty patients eventually completed the study (30/group', 'Sixty-two adult patients who were scheduled for a unilateral TKA']","['continuous adductor canal block (ACB', 'continuous ACB']","['postoperative sufentanil consumption at other time points, pain at rest and during passive knee flexion, quadriceps motor strength, and other recovery related paramaters', 'pain at rest and during passive knee flexion, quadriceps motor strength, and other recovery related paramaters', 'analgesic effect', 'cumulative sufentanil consumption', '24-h sufentanil consumption', 'quadriceps motor strength', 'sufentanil consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",62.0,0.473559,"There were no significant inter-group differences in sufentanil consumption at other time points, pain at rest and during passive knee flexion, quadriceps motor strength, and other recovery related paramaters.
","[{'ForeName': 'Yuda', 'Initials': 'Y', 'LastName': 'Fei', 'Affiliation': 'Anesthesiology Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Shuaifuyuan 1#, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Xulei', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Anesthesiology Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Shuaifuyuan 1#, Dongcheng District, Beijing, 100730, China. cui.xulei@aliyun.com.'}, {'ForeName': 'Shaohui', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Anesthesiology Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Shuaifuyuan 1#, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Huiming', 'Initials': 'H', 'LastName': 'Peng', 'Affiliation': 'Orthopaedic Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Shuaifuyuan 1#, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': 'Orthopaedic Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Shuaifuyuan 1#, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Qian', 'Affiliation': 'Orthopaedic Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Shuaifuyuan 1#, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Orthopaedic Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Shuaifuyuan 1#, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Xisheng', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'Orthopaedic Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Shuaifuyuan 1#, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Anesthesiology Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Shuaifuyuan 1#, Dongcheng District, Beijing, 100730, China.'}]",BMC anesthesiology,['10.1186/s12871-020-01165-w']
2174,33036567,Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial.,"BACKGROUND


Currently, oral targeted therapies are known to be effective and are frequently used to treat metastatic cancer patients, but fatigue is a frequently reported early side effect of these treatments. This fatigue may impact the patient's treatment adherence and result in a negative impact on quality of life. Physical exercise significantly improved the general well-being and quality of life of advanced cancer patients. However, there is no specific physical activity program adapted for patients with advanced disease.
METHODS


QUALIOR is a two-part, randomized, open-label, and multicenter with two arms phase II/III trial. Patients (phase II: n = 120; phase III: n = 312) with metastatic cancer (breast cancer, kidney cancer, lung cancer, and other cancers [including but not limited to colon cancer, melanoma, sarcoma, or hepatocarcinoma]) treated with a first- or second-line oral targeted therapy without chemotherapy will be included. Patients will be randomized (2:1) to a 3-month supervised home-based standardized physical activity program or to a recommended adapted physical activity (via a booklet). The primary objective of the phase II is to evaluate the feasibility of the supervised program. The primary objective of the phase III is the evaluation of the benefit of the supervised home-based program compare to the recommended program in terms of fatigue and quality of life at 3 months. The secondary objectives aim to evaluate the impact of the supervised program on fatigue over time, pain, physical capacities, psychosocial and cognitive functions, general quality of life, frequency of dose reduction and patients' adherence to the targeted therapy, overall survival, and progression-free survival. This study will also evaluate the medico-economic impact of supervised program compared to the recommended adapted physical activity program.
DISCUSSION


The aim of this study is to evaluate home-based physical exercise program for metastatic cancer patients treated with oral targeted therapies to help patients to cope with fatigue and improve quality of life.
TRIAL REGISTRATION


This trial was registered in ClinicalTrials.gov since May 2017 ( NCT03169075 ).",2020,Physical exercise significantly improved the general well-being and quality of life of advanced cancer patients.,"['metastatic cancer patients receiving oral targeted therapy', 'metastatic cancer patients', 'Patients (phase II: n\u2009=\u2009120; phase III: n\u2009=\u2009312) with metastatic cancer (breast cancer, kidney cancer, lung cancer, and other cancers [including but not limited to colon cancer, melanoma, sarcoma, or hepatocarcinoma]) treated with a', 'advanced cancer patients', 'patients with advanced disease']","['Physical exercise', 'supervised program', 'supervised home-based standardized physical activity program or to a recommended adapted physical activity (via a booklet', 'home-based physical exercise program', 'supervised home-based physical exercise program', 'first- or second-line oral targeted therapy without chemotherapy']","['fatigue and quality of life', 'general well-being and quality of life', 'Feasibility and efficacy', ""fatigue over time, pain, physical capacities, psychosocial and cognitive functions, general quality of life, frequency of dose reduction and patients' adherence to the targeted therapy, overall survival, and progression-free survival"", 'quality of life']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0740457', 'cui_str': 'Malignant tumor of kidney'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.047477,Physical exercise significantly improved the general well-being and quality of life of advanced cancer patients.,"[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Joly', 'Affiliation': 'Centre François Baclesse et CHU Côte de Nacre, Caen, France. f.joly@baclesse.unicancer.fr.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lefeuvre-Plesse', 'Affiliation': 'Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Garnier-Tixidre', 'Affiliation': 'Institut Daniel Hollard, Grenoble, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Helissey', 'Affiliation': 'HIA Begin, Saint Mandé, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Menneveau', 'Affiliation': 'CHRU de Besançon, Besançon, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Zannetti', 'Affiliation': 'CH, Cholet, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Salas', 'Affiliation': 'CHU La Timone, Marseille, France.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Houede', 'Affiliation': 'Institut de Cancérologie du Gard, Nîmes, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Abadie-Lacourtoisie', 'Affiliation': 'ICO René Gauducheau, Nantes, France.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Stefani', 'Affiliation': 'CH Annecy Genevois, Pringy, France.'}, {'ForeName': 'Soazig', 'Initials': 'S', 'LastName': 'Nenan', 'Affiliation': 'Unicancer, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Rieger', 'Affiliation': 'Unicancer, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': ""Hôpital de l'Hôtel-Dieu, Paris, France.""}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Descotes', 'Affiliation': 'CAMI Sport et Cancer, Neuilly sur seine, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Anota', 'Affiliation': 'CHRU de Besançon, Besançon, France.'}]",BMC cancer,['10.1186/s12885-020-07381-4']
2175,33036579,Is hypofractionated whole pelvis radiotherapy (WPRT) as well tolerated as conventionally fractionated WPRT in prostate cancer patients? The HOPE trial.,"BACKGROUND


Patients with high-risk prostate cancer are at increased risk of lymph node metastasis and are thought to benefit from whole pelvis radiotherapy (WPRT). There has been recent interest in the use of hypofractionated radiotherapy in treating prostate cancer. However, toxicity and cancer outcomes associated with hypofractionated WPRT are unclear at this time. This phase II study aims to investigate the impact in quality of life associated with hypofractionated WPRT compared to conventionally fractionated WPRT.
METHODS


Fifty-eight patients with unfavourable intermediate-, high- or very high-risk prostate cancer will be randomized in a 1:1 ratio between high-dose-rate brachytherapy (HDR-BT) + conventionally fractionated (45 Gy in 25 fractions) WPRT vs. HDR-BT + hypofractionated (25 Gy in 5 fractions) WPRT. Randomization will be performed with a permuted block design without stratification. The primary endpoint is late bowel toxicity and the secondary endpoints include acute and late urinary and sexual toxicity, acute bowel toxicity, biochemical failure-, androgen deprivation therapy-, metastasis- and prostate cancer-free survival of the hypofractionated arm compared to the conventionally fractionated arm.
DISCUSSION


To our knowledge, this is the first study to compare hypofractionated WPRT to conventionally fractionated WPRT with HDR-BT boost. Hypofractionated WPRT is a more attractive and convenient treatment approach, and may become the new standard of care if demonstrated to be well-tolerated and effective.
TRIAL REGISTRATION


This trial was prospectively registered in ClinicalTrials.gov as NCT04197141 on December 12, 2019.",2020,"This phase II study aims to investigate the impact in quality of life associated with hypofractionated WPRT compared to conventionally fractionated WPRT.
","['Patients with high-risk prostate cancer', 'Fifty-eight patients with unfavourable intermediate-, high- or very high-risk prostate cancer', 'prostate cancer patients']","['hypofractionated whole pelvis radiotherapy (WPRT', 'whole pelvis radiotherapy (WPRT', 'hypofractionated WPRT', 'conventionally fractionated WPRT', 'high-dose-rate brachytherapy (HDR-BT)\u2009+\u2009conventionally fractionated (45\u2009Gy in 25 fractions) WPRT vs. HDR-BT\u2009+\u2009hypofractionated (25\u2009Gy in 5 fractions) WPRT', 'Hypofractionated WPRT', 'hypofractionated radiotherapy']","['late bowel toxicity and the secondary endpoints include acute and late urinary and sexual toxicity, acute bowel toxicity, biochemical failure-, androgen deprivation therapy-, metastasis- and prostate cancer-free survival of the hypofractionated arm compared to the conventionally fractionated arm', 'toxicity and cancer outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0454270', 'cui_str': 'High dose rate brachytherapy'}, {'cui': 'C1158513', 'cui_str': 'Recombinational Repair of DNA'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",58.0,0.108763,"This phase II study aims to investigate the impact in quality of life associated with hypofractionated WPRT compared to conventionally fractionated WPRT.
","[{'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Mendez', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada. lucascastromendez@gmail.com.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Arifin', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Bauman', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Vikram M', 'Initials': 'VM', 'LastName': 'Velker', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Belal', 'Initials': 'B', 'LastName': 'Ahmad', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lock', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Varagur M', 'Initials': 'VM', 'LastName': 'Venkatesan', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Sexton', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Rodrigues', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Physics and Engineering, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Schaly', 'Affiliation': 'Department of Physics and Engineering, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': ""D'Souza"", 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}]",BMC cancer,['10.1186/s12885-020-07490-0']
2176,33039340,"The DANish randomized, double-blind, placebo controlled trial in patients with chronic HEART failure (DANHEART): A 2 x 2 factorial trial of hydralazine-isosorbide dinitrate in patients with chronic heart failure (H-HeFT) and metformin in patients with chronic heart failure and diabetes or prediabetes (met-HeFT).","OBJECTIVES


The DANHEART trial is a multicenter, randomized (1:1), parallel-group, double-blind, placebo-controlled study in chronic heart failure patients with reduced ejection fraction (HFrEF). This investigator driven study will include 1500 HFrEF patients and test in a 2 x 2 factorial design: 1) if hydralazine-isosorbide dinitrate reduces the incidence of death and hospitalization with worsening heart failure vs. placebo (H-HeFT) and 2) if metformin reduces the incidence of death, worsening heart failure, acute myocardial infarction, and stroke vs. placebo in patients with diabetes or prediabetes (Met-HeFT).
METHODS


Symptomatic, optimally treated HFrEF patients with LVEF ≤40% are randomized to active vs. placebo treatment. Patients can be randomized in either both H-HeFT and Met-HeFT or to only one of these study arms. In this event-driven study, it is anticipated that 1300 patients should be included in H-HeFT and 1100 in Met-HeFT and followed for an average of 4years.
RESULTS


As of May 2020, 296 patients have been randomized at 20 centers in Denmark.
CONCLUSION


The H-HeFT and Met-HeFT studies will yield new knowledge about the potential benefit and safety of two commonly prescribed drugs with limited randomized data in patients with HFrEF.",2020,Patients can be randomized in either both H-HeFT and Met-HeFT or to only one of these study arms.,"['296 patients have been randomized at 20 centers in Denmark', '1300 patients should be included in H-HeFT and 1100 in Met-HeFT and followed for an average of 4years', 'patients with chronic HEART failure (DANHEART', 'patients with HFrEF', '1500 HFrEF patients and test in a 2 x 2 factorial design: 1) if', 'patients with diabetes or prediabetes (Met-HeFT', 'Symptomatic, optimally treated HFrEF patients with LVEF ≤40', 'chronic heart failure patients with reduced ejection fraction (HFrEF', 'patients with chronic heart failure (H-HeFT) and metformin in patients with chronic heart failure and diabetes or prediabetes (met-HeFT']","['placebo', 'placebo (H-HeFT) and 2) if metformin', 'hydralazine-isosorbide dinitrate']","['incidence of death and hospitalization with worsening heart failure', 'incidence of death, worsening heart failure, acute myocardial infarction, and stroke vs. placebo']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517537', 'cui_str': '1100'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1628973', 'cui_str': 'Hydralazine / Isosorbide Dinitrate'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",1500.0,0.502629,Patients can be randomized in either both H-HeFT and Met-HeFT or to only one of these study arms.,"[{'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Wiggers', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus. Electronic address: henrikwiggers@dadlnet.dk.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Gislason', 'Affiliation': 'The Danish Heart Foundation.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Herlev Hospital.'}, {'ForeName': 'Mikael Kjær', 'Initials': 'MK', 'LastName': 'Poulsen', 'Affiliation': 'Department of Cardiology, Odense University Hospital.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Vraa', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital.'}, {'ForeName': 'Olav Wendelbo', 'Initials': 'OW', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Bispebjerg Hospital.'}, {'ForeName': 'Niels Eske', 'Initials': 'NE', 'LastName': 'Bruun', 'Affiliation': 'Department of Cardiology, Roskilde Hospital.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Nørrelund', 'Affiliation': 'Clinical Trial Unit, Aarhus University Hospital.'}, {'ForeName': 'Malene', 'Initials': 'M', 'LastName': 'Hollingdal', 'Affiliation': 'Department of Cardiology, Viborg Hospital.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Barasa', 'Affiliation': 'Department of Cardiology, Hvidovre Hospital.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Bøttcher', 'Affiliation': 'Department of Cardiology, Herning Hospital.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dodt', 'Affiliation': 'Department of Cardiology, Horsens Hospital.'}, {'ForeName': 'Vibeke Brogaard', 'Initials': 'VB', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, Lillebaelt Hospital, Vejle Hospital.'}, {'ForeName': 'Gitte', 'Initials': 'G', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Hjørring Hospital.'}, {'ForeName': 'Anne Sejr', 'Initials': 'AS', 'LastName': 'Knudsen', 'Affiliation': 'Department of Cardiology, Silkeborg Hospital.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Lomholdt', 'Affiliation': 'Department of Cardiology, Slagelse Hospital.'}, {'ForeName': 'Kirsten Vilain', 'Initials': 'KV', 'LastName': 'Mikkelsen', 'Affiliation': 'Department of Cardiology, Sydvestjysk Sygehus, Esbjerg.'}, {'ForeName': 'Bartlomiej', 'Initials': 'B', 'LastName': 'Jonczy', 'Affiliation': 'Department of Cardiology, Sygehus Sønderjylland, Abenraa.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Brønnum-Schou', 'Affiliation': 'Amager Hospital.'}, {'ForeName': 'Monica Petronela', 'Initials': 'MP', 'LastName': 'Poenaru', 'Affiliation': 'Department of Cardiology, Lillebaelt Hospital, Kolding.'}, {'ForeName': 'Jawdat', 'Initials': 'J', 'LastName': 'Abdulla', 'Affiliation': 'Department of Medicine, Cardiology section, Glostrup Hospital.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Raymond', 'Affiliation': 'Department of Cardiology, Holbæk Hospital, Holbæk.'}, {'ForeName': 'Kiomars', 'Initials': 'K', 'LastName': 'Mahboubi', 'Affiliation': 'Department of Cardiology, Randers Hospital, Randers.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sillesen', 'Affiliation': 'The Pharmacy, Aarhus University Hospital.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Serup-Hansen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital.'}, {'ForeName': 'Jette Sandberg', 'Initials': 'JS', 'LastName': 'Madsen', 'Affiliation': 'Department of Cardiology, Gentofte Hospital.'}, {'ForeName': 'Søren Lund', 'Initials': 'SL', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen.'}, {'ForeName': 'Anders Hostrup', 'Initials': 'AH', 'LastName': 'Larsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital.'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Petersen', 'Affiliation': 'Department of Cardiology, Hillerød Hospital.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Eiskjær', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Møller', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen.'}, {'ForeName': 'Flemming Hald', 'Initials': 'FH', 'LastName': 'Steffensen', 'Affiliation': 'Department of Cardiology, Lillebaelt Hospital, Vejle.'}, {'ForeName': 'Bo Martin', 'Initials': 'BM', 'LastName': 'Bibby', 'Affiliation': 'Department of Biostatistics, Aarhus University, Aarhus.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Refsgaard', 'Affiliation': 'Department of Cardiology, Viborg Hospital.'}, {'ForeName': 'Dan Eik', 'Initials': 'DE', 'LastName': 'Høfsten', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Mellemkjær', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen. Electronic address: Finn.Gustafsson@regionh.dk.'}]",American heart journal,['10.1016/j.ahj.2020.09.020']
2177,33039382,Early changes in appetite and energy expenditure are not associated to body weight and fat losses in pre-menopausal women living with overweight/obesity.,"BACKGROUND


The aim of the study was to investigate whether early changes (1-week) in energy balance-related measures would predict changes in body weight (BW) and fat losses in women living with overweight/obesity.
METHODS


BW, body composition (DXA), resting energy expenditure (REE)(indirect calorimetry), olfactory performance (Sniffin' Sticks), appetite and palatability (visual analogue scale) were measured at baseline, after a 1-week of caloric restriction as well as post-intervention (at 10 and 20 weeks) in a group of 30 women living with overweight/obesity.
RESULTS


A significant decrease in REE (p = 0.033) was noted after 1 week. Fasting desire to eat (p = 0.004), hunger (p = 0.001) and prospective food consumption (p = 0.001) all increased after 1 week. Similarly, significant increases in AUC SQ for desire to eat (p = 0.01), hunger (p = 0.005) and prospective food consumption (p = 0.001) were noted after 1 week. However, these early changes were not associated to final BW or FM losses at the end of the weight loss intervention.
CONCLUSION


Despite significant changes in REE and appetite soon after the onset of a BW loss intervention, these early changes do not seem to predict final BW or FM losses at the end of the program in women living with overweight/obesity.",2020,"Similarly, significant increases in AUC SQ for desire to eat (p = 0.01), hunger (p = 0.005) and prospective food consumption (p = 0.001) were noted after 1 week.","['pre-menopausal women living with overweight/obesity', '30 women living with overweight/obesity', 'women living with overweight/obesity']",[],"['appetite and energy expenditure', 'Fasting desire to eat', 'body weight (BW) and fat losses', 'prospective food consumption', 'final BW or FM losses', 'REE and appetite', 'hunger', ""body composition (DXA), resting energy expenditure (REE)(indirect calorimetry), olfactory performance (Sniffin' Sticks), appetite and palatability (visual analogue scale"", 'body weight and fat losses', 'REE', 'AUC SQ for desire to eat']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],"[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0006779', 'cui_str': 'Calorimetry'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C1706582', 'cui_str': 'Stick'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",30.0,0.0260886,"Similarly, significant increases in AUC SQ for desire to eat (p = 0.01), hunger (p = 0.005) and prospective food consumption (p = 0.001) were noted after 1 week.","[{'ForeName': 'Luzia Jaeger', 'Initials': 'LJ', 'LastName': 'Hintze', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Goldfield', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, K1H 8L1, Canada.""}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Séguin', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada; Ryan Séguin is deceased.'}, {'ForeName': 'Aleck', 'Initials': 'A', 'LastName': 'Damphousse', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Riopel', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Doucet', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada. Electronic address: edoucet@uottawa.ca.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113201']
2178,33039447,N-Terminal Pro-B-Type Natriuretic Peptide and Clinical Outcomes: Vericiguat Heart Failure With Reduced Ejection Fraction Study.,"OBJECTIVES


The purpose of this study was to examine the treatment effect of vericiguat in relation to N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels at randomization.
BACKGROUND


Vericiguat compared with placebo reduced the primary outcome of cardiovascular death (CVD) or heart failure hospitalization (HFH) in patients with HF with reduced ejection fraction (HFrEF) in the VICTORIA (A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction) trial. Because an interaction existed between treatment and the primary outcome according to pre-specified quartiles of NT-proBNP at randomization, we examined this further.
METHODS


This study evaluated the NT-proBNP relationship with the primary outcome in 4,805 of 5,050 patients as a risk-adjusted, log-transformed continuous variable. Hazard ratios (HRs) and 95% confidence intervals (CIs) are presented.
RESULTS


Median NT-proBNP was 2,816 pg/ml (25th to 75th percentile: 1,556 to 5,314 pg/ml). The study treatment effect varied across the spectrum of NT-proBNP at randomization (with log 2  transformation, p for interaction = 0.002). A significant association between treatment effects existed in patients with levels <4,000 pg/ml and remained evident up to 8,000 pg/ml. A 23% relative risk reduction occurred in the primary endpoint with NT-proBNP ≤4,000 pg/ml (HR: 0.77; 95% CI: 0.68 to 0.88). For NT-proBNP values ≤4,000 pg/ml (n = 3,100), the HR was 0.78 (95% CI: 0.67 to 0.90) for HFH and 0.75 (95% CI: 0.60 to 0.94) for CVD. For NT-proBNP ≤8,000 pg/ml (n = 4,133), the HR was 0.85 (95% CI: 0.76 to 0.95) for the primary outcome, 0.84 (95% CI: 0.75 to 0.95) for HFH, and 0.84 (95% CI: 0.71 to 0.99) for CVD. For NT-proBNP >8,000 pg/ml (n = 672), the HR was 1.16 (95% CI: 0.94 to 1.41) for the primary outcome.
CONCLUSIONS


A reduction in the primary composite endpoint and its CVD and HFH components was observed in patients on vericiguat compared with subjects on placebo with NT-proBNP levels up to 8,000 pg/ml. This provided new insight into the benefit observed in high-risk patients with worsening HFrEF. (A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction [HFrEF] [MK-1242-001] [VICTORIA]; NCT02861534).",2020,"A 23% relative risk reduction occurred in the primary endpoint with NT-proBNP ≤4,000 pg/ml (HR: 0.77; 95% CI: 0.68 to 0.88).","['4,805 of 5,050 patients as a risk-adjusted, log-transformed continuous variable', 'high-risk patients with worsening HFrEF', 'patients with HF with reduced ejection fraction (HFrEF) in the VICTORIA (A Study of Vericiguat in Participants With Heart\xa0Failure With Reduced Ejection Fraction) trial', 'Participants With Heart']","['HFrEF', 'placebo', 'MK-1242-001] [VICTORIA']","['cardiovascular death (CVD) or heart failure hospitalization (HFH', 'Hazard ratios (HRs) and 95% confidence intervals (CIs', 'Vericiguat Heart', 'CVD and HFH components', 'Failure With Reduced Ejection Fraction', 'risk reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",,0.381183,"A 23% relative risk reduction occurred in the primary endpoint with NT-proBNP ≤4,000 pg/ml (HR: 0.77; 95% CI: 0.68 to 0.88).","[{'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': 'Division of Cardiology, Department of Medicine, Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina; Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Troughton', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Wendimagegn G', 'Initials': 'WG', 'LastName': 'Alemayehu', 'Affiliation': 'Division of Cardiology, Department of Medicine, Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Westerhout', 'Affiliation': 'Division of Cardiology, Department of Medicine, Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'Department of Cardiology and Thorax Surgery, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'Department of Cardiology and Thorax Surgery, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; Department of Cardiology, National Heart Centre Singapore and Duke-National University of Singapore.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Wroclaw Medical University, Department of Heart Disease, Wroclaw, Poland.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Emdin', 'Affiliation': ""Cardiothoracic Department, Fondazione Toscana Gabriele Monasterio, Pisa, Italy; and Institute of Life Sciences, Scuola Superiore Sant'Anna, Pisa, Italy.""}, {'ForeName': 'Mahesh J', 'Initials': 'MJ', 'LastName': 'Patel', 'Affiliation': 'Merck & Co. Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Department of Internal Medicine-Cardiology, Charité University Medicine, German Heart Center, Berlin, Germany.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Division of Cardiology, Department of Medicine, Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada. Electronic address: parmstro@ualberta.ca.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.08.008']
2179,33039448,Estimating the Lifetime Benefits of Treatments for Heart Failure.,"OBJECTIVES


This study compared ways of describing treatment effects. The objective was to better explain to clinicians and patients what they might expect from a given treatment, not only in terms of relative and absolute risk reduction, but also in projections of long-term survival.
BACKGROUND


The restricted mean survival time (RMST) can be used to estimate of long-term survival, providing a complementary approach to more conventional metrics (e.g., absolute and relative risk), which may suggest greater benefits of therapy in high-risk patients compared with low-risk patients.
METHODS


Relative and absolute risk, as well as the RMST, were calculated in heart failure with reduced ejection fraction (HFrEF) trials.
RESULTS


As examples, in the RALES trial (more severe HFrEF), the treatment effect metrics for spironolactone versus placebo on heart failure hospitalization and/or cardiovascular death were a hazard ratio (HR) of 0.67 (95% confidence interval [CI]: 0.5 to 0.77), number needed to treat = 9 (7 to 14), and age extension of event-free survival +1.1 years (-0.1 to + 2.3 years). The corresponding metrics for EMPHASIS-HF (eplerenone vs. placebo in less severe HFrEF) were 0.64 (0.54 to 0.75), 14 (1 to 22), and +2.9 (1.2 to 4.5). In patients in PARADIGM-HF aged younger than 65 years, the metrics for sacubitril/valsartan versus enalapril were 0.77 (95% CI: 0.68 to 0.88), 23 (15 to 44), and +1.7 (0.6 to 2.8) years; for those aged 65 years or older, the metrics were 0.83 (95% CI: 0.73 to 0.94), 29 (17 to 83), and +0.9 (0.2 to 1.6) years, which provided evidence of a greater potential life extension in younger patients. Similar observations were found for lower risk patients.
CONCLUSIONS


RMST event-free (and overall) survival estimates provided a complementary means of evaluating the effect of therapy in relation to age and risk. They also provided a clinically useful metric that should be routinely reported and used to explain the potential long-term benefits of a given treatment, especially to younger and less symptomatic patients.",2020,"The corresponding metrics for EMPHASIS-HF (eplerenone vs. placebo in less severe HFrEF) were 0.64 (0.54 to 0.75), 14 (1 to 22), and +2.9 (1.2 to 4.5).",[],"['placebo', 'sacubitril/valsartan versus enalapril', 'HF (eplerenone vs. placebo', 'spironolactone']","['age extension of event-free survival', 'number needed to treat\xa0', 'heart failure hospitalization and/or cardiovascular death', 'RMST event-free (and overall) survival estimates', 'mean survival time (RMST']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",,0.184145,"The corresponding metrics for EMPHASIS-HF (eplerenone vs. placebo in less severe HFrEF) were 0.64 (0.54 to 0.75), 14 (1 to 22), and +2.9 (1.2 to 4.5).","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom; National Institute of Health and Medical Research (INSERM), Center for Clinical Multidisciplinary Research 1433, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network (F-CRIN) Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists (INI-CRCT), Nancy, France.'}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stienen', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences. Amsterdam University Medical Center, University of Amsterdam, Amsterdam the Netherlands.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gregson', 'Affiliation': 'Department of Biostatistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': 'Department of Biostatistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'National Institute of Health and Medical Research (INSERM), Center for Clinical Multidisciplinary Research 1433, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network (F-CRIN) Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists (INI-CRCT), Nancy, France.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom. Electronic address: john.mcmurray@glasgow.ac.uk.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.08.004']
2180,33039693,Semaglutide for the treatment of non-alcoholic steatohepatitis: Trial design and comparison of non-invasive biomarkers.,"Non-alcoholic steatohepatitis (NASH) is a chronic liver disease. There is a clear need to develop pharmacological treatment for patients with NASH as well as biomarkers that can diagnose the disease. We describe a trial of semaglutide treatment for NASH, identify key patient characteristics and compare the relationship of patient characteristics and non-invasive biomarkers/scores. NCT02970942 is a randomised, double-blind, placebo-controlled, multi-national Phase 2 trial of daily subcutaneous semaglutide (0.1 mg, 0.2 mg, 0.4 mg) in patients with biopsy-confirmed NASH, F1-F3 fibrosis, NAFLD Activity Score ≥ 4, and body mass index (BMI) > 25 kg/m 2 . Exploratory analyses were performed to evaluate correlations between baseline parameters and biomarkers in NASH. Mean (standard deviation [SD]) age of 320 randomised patients was 55 (11) years, mean BMI was 36 (6) kg/m 2 , and 199 (62%) had type 2 diabetes. Of the total patients, 28% had F1 fibrosis, 23% had F2 fibrosis and 49% had F3 fibrosis. The highest area under the receiver operating characteristic curve (0.69) for accuracy in classifying fibrosis stage, F2-3 versus F1, was observed for Fib-4 and Enhanced Liver Fibrosis (ELF). No substantial correlation between BMI or other clinical or biochemical parameters and fibrosis stage was observed. In this large Phase 2 trial of semaglutide treatment for NASH, the clinical profile of enrolled patients was typical for patients with NASH. Of the investigated biomarkers/scores, ELF and Fib-4 showed the most apparent correlation in classifying fibrosis stage, but had only moderate predictive value.",2020,"Of the investigated biomarkers/scores, ELF and Fib-4 showed the most apparent correlation in classifying fibrosis stage, but had only moderate predictive value.","['enrolled patients was typical for patients with NASH', 'patients with biopsy-confirmed NASH', 'patients with NASH', '\u202f25', 'age of 320 randomised patients was 55 (11) years, mean BMI was 36 (6) kg/m 2 , and 199 (62%) had type 2 diabetes']","['daily subcutaneous semaglutide', 'placebo']","['Mean (standard deviation [SD', 'F3 fibrosis', '≥\u202f4, and body mass index (BMI', 'F2 fibrosis', 'F1 fibrosis', 'F1-F3 fibrosis, NAFLD Activity Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0910435', 'cui_str': 'AM 36'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0949122,"Of the investigated biomarkers/scores, ELF and Fib-4 showed the most apparent correlation in classifying fibrosis stage, but had only moderate predictive value.","[{'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Radcliffe Department of Medicine, University of Oxford, Oxford, OX3 9DU, UK. Electronic address: stephenharrison87@gmail.com.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Calanna', 'Affiliation': 'Novo Nordisk A/S, 2860 Søborg, Denmark. Electronic address: sca@novonordisk.com.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Cusi', 'Affiliation': 'Division of Endocrinology, Diabetes & Metabolism, University of Florida, Gainesville, FL 32608, USA; Endocrinology, Diabetes and Metabolism, Malcom Randall VA Medical Center, Gainesville, FL 32608, USA. Electronic address: Kenneth.Cusi@medicine.ufl.edu.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Linder', 'Affiliation': 'Novo Nordisk A/S, 2860 Søborg, Denmark. Electronic address: MLIX@novonordisk.com.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Okanoue', 'Affiliation': 'Department of Gastroenterology & Hepatology, Saiseikai Suita Hospital, Suita, Japan. Electronic address: okanoue@suita.saiseikai.or.jp.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Ratziu', 'Affiliation': 'Sorbonne University, ICAN - Institute for Cardiometabolism and Nutrition, Hôpital Pitié Salpêtrière, 75013 Paris, France. Electronic address: vlad.ratziu@inserm.fr.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Sanyal', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Internal Medicine, Virginia Commonwealth University, Richmond, VA 23284, USA. Electronic address: arun.sanyal@vcuhealth.org.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Sejling', 'Affiliation': 'Novo Nordisk A/S, 2860 Søborg, Denmark. Electronic address: asji@novonordisk.com.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Newsome', 'Affiliation': 'National Institute for Health Research Birmingham Biomedical Research Centre and Liver Unit at University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Centre for Liver & Gastrointestinal Research, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham B15 2TT, UK. Electronic address: P.N.Newsome@bham.ac.uk.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106174']
2181,33039717,Nasal function and cardio-respiratory capacity of adolescent with external nasal dilator.,"BACKGROUND


the external nasal dilator (END) has been employed for the purpose of aiding sporting performance. The objective of this study was to evaluate nasal function and cardio-respiratory capacity in healthy adolescent athletes using the END.
METHODS


double-blind, crossover clinical trial in which adolescents were evaluated while using the experimental and placebo END during physical exercise. Values for peak nasal inspiratory flow (PNIF), nasal resistance (NR) and maximal oxygen uptake (VO 2 max) were obtained in randomized order. Additionally, the rating of perceived exertion (RPE) after the cardio-respiratory test was assessed.
RESULTS


for the 71 adolescents evaluated, the use of the experimental END, compared to the placebo, produced a significant improvement in values of PNIF (177.4 ± 20.9 L/min and 172.8 ± 20.2 L/min) (p = 0.020), NR (0.24 ± 0.16 and 0.27 ± 0.16) (p = 0.007), VO 2 max. (39.5 ± 5.2 mL/kg. min-1 and 37.5 ± 5.2 mL/kg. min-1) (p < 0.001) and RPE (6.0 ± 2.2 and 5.5 ± 2.4) (p < 0.001), respectively.
CONCLUSION


the END reduced NR, increased PNIF and improved VO 2 max. In addition, it improved RPE after the maximal cardio-respiratory test. The use of the END can significantly improve nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion during a maximal test involving adolescent athletes.",2020,"The use of the END can significantly improve nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion during a maximal test involving adolescent athletes.","['adolescent with external nasal dilator', 'healthy adolescent athletes', 'adolescent athletes']","['placebo', 'external nasal dilator (END']","['rating of perceived exertion (RPE', 'Nasal function and cardio-respiratory capacity', 'values of PNIF', 'nasal function and cardio-respiratory capacity', 'PNIF and improved VO 2 max', 'nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion', 'peak nasal inspiratory flow (PNIF), nasal resistance (NR) and maximal oxygen uptake (VO 2 max']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0180437', 'cui_str': 'Nasal dilator'}, {'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0180437', 'cui_str': 'Nasal dilator'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429205', 'cui_str': 'Nasal peak inspiratory flow'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0429208', 'cui_str': 'Nasal resistance'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",,0.146487,"The use of the END can significantly improve nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion during a maximal test involving adolescent athletes.","[{'ForeName': 'Carlos Henrique', 'Initials': 'CH', 'LastName': 'Santos Ferreira', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Ricardo Reis', 'Initials': 'RR', 'LastName': 'Dinardi', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil; Pontifical Catholic University of Minas Gerais, Department of Physical Education. Belo Horizonte, MG, Brazil. Electronic address: dinardi06@hotmail.com.'}, {'ForeName': 'Cássio', 'Initials': 'C', 'LastName': 'da Cunha Ibiapina', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Ribeiro de Andrade', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110430']
2182,33039810,"Effect of urea cream on sorafenib-associated hand-foot skin reaction in patients with hepatocellular carcinoma: A multicenter, randomised, double-blind controlled study.","BACKGROUND


Hand-foot skin reaction (HFSR) is the most common adverse event during sorafenib treatment in patients with hepatocellular carcinoma (HCC). In the present study, we aimed to investigate the role of urea cream in the prevention of HFSR or amelioration of HFSR severity.
PATIENTS AND METHODS


Patients with HCC were treated with either placebo cream or urea cream for 12 weeks concomitantly with sorafenib treatment. HFSR development, the Hand-Foot Skin Reaction and Quality of Life (HF-QoL) questionnaire score, and adverse events were assessed at 2, 4, 8 and 12 weeks.
RESULTS


Of the 288 patients, 247 patients, with 117 patients in the placebo control group and 130 patients in the urea cream group, were analysed. The urea cream group showed a trend towards a lower cumulative incidence of any-grade HFSR (log-rank, P = 0.247) and severe HFSR of grade II or higher (log-rank, P = 0.394) without statistical significance. In the incidence by time point, the incidence of severe HFSR of grade II or higher was significantly lower in the urea cream group than in the placebo control group at 2 weeks (13.8% versus 23.9%, P = 0.042). The urea cream group showed a significantly better HF-QoL questionnaire score than the placebo control group (11.8 versus 19.7, P = 0.014) at 12 weeks.
CONCLUSIONS


Treatment with urea cream showed a lower incidence of severe sorafenib-induced HFSR at 2 weeks and reduced the tendency of HFSR development in HCC patients. Therefore, treatment with urea cream may be considered for prophylaxis or improvement of HFSR grade in HCC patients treated with sorafenib.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03212625).",2020,"The urea cream group showed a significantly better HF-QoL questionnaire score than the placebo control group (11.8 versus 19.7, P = 0.014) at 12 weeks.
","['Patients with HCC', 'patients with hepatocellular carcinoma', 'patients with hepatocellular carcinoma (HCC', '288 patients, 247 patients, with 117 patients in the placebo control group and 130 patients in the urea cream group']","['Hand-foot skin reaction (HFSR', 'placebo cream or urea cream', 'sorafenib treatment', 'urea cream']","['incidence of severe HFSR of grade II or higher', 'HFSR development, the Hand-Foot Skin Reaction and Quality of Life (HF-QoL) questionnaire score, and adverse events', 'HF-QoL questionnaire score', 'cumulative incidence of any-grade HFSR', 'tendency of HFSR development', 'severe HFSR of grade II', 'sorafenib-associated hand-foot skin reaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",288.0,0.149479,"The urea cream group showed a significantly better HF-QoL questionnaire score than the placebo control group (11.8 versus 19.7, P = 0.014) at 12 weeks.
","[{'ForeName': 'Young-Sun', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea. Electronic address: lys810@korea.ac.kr.'}, {'ForeName': 'Young K', 'Initials': 'YK', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ji H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea. Electronic address: kjhhepar@naver.com.'}, {'ForeName': 'Sung B', 'Initials': 'SB', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Chonnam National University Medical School, South Korea. Electronic address: portalvein@naver.com.'}, {'ForeName': 'Do Y', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Yonsei Liver Center, Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'Moon Y', 'Initials': 'MY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju Severance Christan Hospital, South Korea.'}, {'ForeName': 'Hyung J', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yeon S', 'Initials': 'YS', 'LastName': 'Seo', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ki T', 'Initials': 'KT', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Pusan National University College of Medicine, Liver center, Pusan National University Yangsan Hospital, Yangsan, South Korea.'}, {'ForeName': 'Young M', 'Initials': 'YM', 'LastName': 'Hong', 'Affiliation': 'Department of Internal Medicine, Pusan National University College of Medicine, Liver center, Pusan National University Yangsan Hospital, Yangsan, South Korea.'}, {'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, South Korea.'}, {'ForeName': 'Hyun W', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, South Korea.'}, {'ForeName': 'Hyung J', 'Initials': 'HJ', 'LastName': 'Yim', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Byoung K', 'Initials': 'BK', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Keimyung University School of Medicine, South Korea.'}, {'ForeName': 'Eun S', 'Initials': 'ES', 'LastName': 'Jang', 'Affiliation': 'Department of Intetnal Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi, South Korea.'}, {'ForeName': 'Jae Y', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Soonchunhyang University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sang Y', 'Initials': 'SY', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, Dongnam Institute of Radiological & Medical Sciences, South Korea.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.09.012']
2183,33039853,Effectiveness of expiratory flow acceleration in patients with Parkinson's disease and swallowing deficiency: A preliminary study.,"OBJECTIVES


Parkinson's disease (PD) causes dysfunction both to swallowing and to the cough mechanism. Oropharyngeal dysphagia is the main cause of pneumonia, due to silent aspiration of food and saliva. Pneumonia is the leading cause of death in PD. Different strategies exist to reduce the risk of inhalation and associated lung infections, but evidence of their efficacy is still unclear. The aim of this preliminary study was to investigate if adding an expiratory flow acceleration (EFA®) technique to standard therapy (ST) for dysphagia can reduce the incidence of bronchopulmonary infections and improve quality of life, respiratory function parameters, cough, and airways encumbrance perception.
MATERIALS AND METHODS


Twenty-five patients with PD were randomized to two groups: ST vs. ST + EFA. Patients were re-assessed at 30, 180 and 360 days from start of treatment. The primary outcome was the incidence of respiratory exacerbations together with quality of life score (PDQ-39). Secondary outcomes were changes in respiratory function tests, cough capacity (CPEF), perceived health status (Euro-QOL-VAS), cough, and upper airways encumbrance perception evaluated by visual numeric scale (VNS).
RESULTS


Twenty patients concluded the study (10 each group). Albeit the difference was not significant, less respiratory infections, symptoms, hospital admissions and medical visits were found in the study group. Furthermore, there was a significant difference in cough effectiveness measured with the peak cough expiratory flow (PCEF) and other spirometry parameters (FEV 1 , FVC), and also in specific and generic health-related quality of life measures (PDQ-39, Euro-QoL-VAS).
CONCLUSION


The results of this preliminary study support the use of EFA® technology in Parkinson's patients with dysphagia to reduce the risk of respiratory complications. Nevertheless, further studies are needed in a larger, more representative sample to definitively confirm the usefulness of this technique in PD patients.",2020,"Albeit the difference was not significant, less respiratory infections, symptoms, hospital admissions and medical visits were found in the study group.","[""Parkinson's patients with dysphagia"", 'Twenty-five patients with PD', 'Twenty patients concluded the study (10 each group', ""patients with Parkinson's disease and swallowing deficiency""]","['expiratory flow acceleration (EFA®) technique to standard therapy (ST', 'EFA® technology', 'expiratory flow acceleration', 'ST vs. ST\u202f+\u202fEFA']","['cough effectiveness', 'changes in respiratory function tests, cough capacity (CPEF), perceived health status (Euro-QOL-VAS), cough, and upper airways encumbrance perception evaluated by visual numeric scale (VNS', 'peak cough expiratory flow (PCEF) and other spirometry parameters (FEV 1 , FVC), and also in specific and generic health-related quality of life measures (PDQ-39, Euro-QoL-VAS', 'respiratory infections, symptoms, hospital admissions and medical visits', 'incidence of respiratory exacerbations together with quality of life score (PDQ-39', 'quality of life, respiratory function parameters, cough, and airways encumbrance perception']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0917903', 'cui_str': 'Conclude Composite Resin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4759659', 'cui_str': 'With quality'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]",25.0,0.0541415,"Albeit the difference was not significant, less respiratory infections, symptoms, hospital admissions and medical visits were found in the study group.","[{'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Riboldazzi', 'Affiliation': ""Parkinson's Disease Unit, Gaetano and Piera Borghi Foundation, Brebbia, Italy.""}, {'ForeName': 'Giada', 'Initials': 'G', 'LastName': 'Spinazza', 'Affiliation': 'Neurology Rehabilitation Department, Hospital of Cuasso al Monte, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Beccarelli', 'Affiliation': 'Pulmonary Rehabilitation Unit, General Hospital, Sestri Levante, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Prato', 'Affiliation': 'Pulmonary Rehabilitation Unit, General Hospital, Sestri Levante, Italy.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Grecchi', 'Affiliation': 'Physical Medicine and Rehabilitation Department, General Hospital, Sestri Levante, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': ""D'Abrosca"", 'Affiliation': 'Italian Association of Respiratory Physiotherapists (ARIR), Milan, Italy.'}, {'ForeName': 'Antonello', 'Initials': 'A', 'LastName': 'Nicolini', 'Affiliation': 'Pulmonary Rehabilitation Unit, General Hospital, Sestri Levante, Italy. Electronic address: antonellonicolini@gmail.com.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106249']
2184,33040011,Is arthropla S ty b E tter than inter N al fixation for undi S placed femoral n E ck fracture? A national pragmatic RCT: the  SENSE  trial.,"INTRODUCTION


Undisplaced femoral neck fractures (FNFs) are usually treated by internal fixation (IF) but two randomised controlled trials (RCTs) have demonstrated advantages of treatment with arthroplasty. The complication rate was lowered but there were no clinically improved patient-reported outcome measures (PROM), which could be due to underpowering or choice of selected PROM as the studies do appear to report a better functional outcome. We will conduct an RCT comparing IF with arthroplasties in patients aged over 65 years with an undisplaced FNF.
METHODS AND ANALYSIS


All hospitals in Denmark treating patients with hip fracture can provide patients for this study; therefore, the study can be considered a national RCT. Patients over 65 years old with an undisplaced FNF will be screened for eligibility and patients will only be excluded if they are unable to understand the study information (due to dementia or language), if they have a posterior tilt >20°, a pathological fracture or they cannot walk. Participants will be electronically randomised (in alternating blocks of 4 or 6) into either IF or arthroplasty. Postoperative care will follow the department standards.Primary and secondary outcomes and measuring points have been established in collaboration with patients with hip fracture by focus group interviews. The primary outcome measure is the New Mobility Score assessed after 1 year. Secondary outcomes are the Oxford Hip Score, EuroQol 5 domain (EQ-5D-5L), degree of posterior tilt, pain Verbal Rating Scale, reoperation and mortality.
ETHICS AND DISSEMINATION


The study is approved by the Danish Data Protection Agency (19/7429) and the scientific ethics committee (S-20180036). All participants will sign an informed consent before entering the trial. Because this is a national trial, all relevant healthcare professionals in Denmark will automatically receive the trial results that will be published in international peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT04075461).",2020,"The complication rate was lowered but there were no clinically improved patient-reported outcome measures (PROM), which could be due to underpowering or choice of selected PROM as the studies do appear to report a better functional outcome.","['All hospitals in Denmark treating patients with hip fracture', 'patients aged over 65 years with an undisplaced FNF', 'Patients over 65 years old with an']","['IF or arthroplasty', 'undisplaced FNF']","['New Mobility Score assessed after 1\u2009year', 'Oxford Hip Score, EuroQol 5 domain (EQ-5D-5L), degree of posterior tilt, pain Verbal Rating Scale, reoperation and mortality', 'complication rate']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443336', 'cui_str': 'Undisplaced'}, {'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0443336', 'cui_str': 'Undisplaced'}, {'cui': 'C0033228', 'cui_str': 'Fenofibrate'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1998079', 'cui_str': 'Oxford hip score'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.3056,"The complication rate was lowered but there were no clinically improved patient-reported outcome measures (PROM), which could be due to underpowering or choice of selected PROM as the studies do appear to report a better functional outcome.","[{'ForeName': 'Bjarke', 'Initials': 'B', 'LastName': 'Viberg', 'Affiliation': 'Orthopaedic Surgery and Traumatology, Lillebaelt Hospital, University Hospital of Southern Denmark, Kolding, Denmark bjarke.viberg@rsyd.dk.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Kold', 'Affiliation': 'Orthopaedic Surgery and Traumatology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Brink', 'Affiliation': 'Orthopaedic Surgery and Traumatology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Morten Schultz', 'Initials': 'MS', 'LastName': 'Larsen', 'Affiliation': 'Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Kristoffer Borbjerg', 'Initials': 'KB', 'LastName': 'Hare', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Palm', 'Affiliation': 'Orthopaedic Surgery and Traumatology, Bispebjerg Hospital, Kobenhavn, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-038442']
2185,33040012,"Validation of an integrated service model, Health-RESPECT, for older patients in long-term care institution using information and communication technologies: protocol of a cluster randomised controlled trial.","INTRODUCTION


There is an increased healthcare need to manage institutionalised older patients owing to the ageing population. To overcome substantial future challenges, the Health-RESPECT (caRE Systems for Patients/Elderly with Coordinated care using icT), a new information and communication technologies based integrated management service model, was developed to provide effective management, enable consultation with distant professionals and share medical information between acute care hospitals and long-term care institutions.
METHODS AND ANALYSIS


A cluster randomised controlled trial will be conducted to examine the effectiveness of the Health-RESPECT in older patients with chronic diseases and their medical staff in charge. Intervention involves registration with simple comprehensive geriatric assessment, establishment of an individualised care plan for three chronic diseases (hypertension, diabetes and heart failure), medication and rehabilitation management, periodic video-conference and in-system assessment after intervention period. Primary outcomes are control levels of the three chronic diseases, adequacy of drug management and overall functional status. Patients will be assessed at before and after study period and 3 months after study ended. Analysis will be carried out with an intention-to-treat principle. In addition to evaluate intervention effects, clinical usability and economic evaluation will be assessed.
ETHICS AND DISSEMINATION


The study protocol was reviewed and approved by the Seoul National University Bundang Hospital Institutional Review Board. Study findings will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


KCT0004360.",2020,A cluster randomised controlled trial will be conducted to examine the effectiveness of the Health-RESPECT in older patients with chronic diseases and their medical staff in charge.,"['older patients with chronic diseases and their medical staff in charge', 'Patients/Elderly with Coordinated care using icT', 'older patients in long-term care institution']","['Intervention involves registration with simple comprehensive geriatric assessment, establishment of an individualised care plan']","['control levels of the three chronic diseases, adequacy of drug management and overall functional status']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0025106', 'cui_str': 'Medical Staffs'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",3.0,0.0862522,A cluster randomised controlled trial will be conducted to examine the effectiveness of the Health-RESPECT in older patients with chronic diseases and their medical staff in charge.,"[{'ForeName': 'Jung-Yeon', 'Initials': 'JY', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea (the Republic of).'}, {'ForeName': 'Kwang-Il', 'Initials': 'KI', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea (the Republic of) kikim907@snu.ac.kr.'}, {'ForeName': 'Hongsoo', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Public Health Sciences, Seoul National University Graduate School of Public Health, Gwanak-gu, Korea (the Republic of).'}, {'ForeName': 'Young-Il', 'Initials': 'YI', 'LastName': 'Jung', 'Affiliation': 'Department of Environmental Health, Korea National Open University, Jongno-gu, Korea (the Republic of).'}, {'ForeName': 'In-Hwan', 'Initials': 'IH', 'LastName': 'Oh', 'Affiliation': 'Department of Preventive Medicine, Kyung Hee University, Seoul, Korea (the Republic of).'}, {'ForeName': 'Seungyeon', 'Initials': 'S', 'LastName': 'Chun', 'Affiliation': 'Department of Public Health Sciences, Seoul National University Graduate School of Public Health, Gwanak-gu, Korea (the Republic of).'}, {'ForeName': 'Gi-Soo', 'Initials': 'GS', 'LastName': 'Kim', 'Affiliation': 'Department of Industrial Engineering, Ulsan National Institute of Science and Technology, Ulsan, Korea (the Republic of).'}, {'ForeName': 'Jae-Young', 'Initials': 'JY', 'LastName': 'Lim', 'Affiliation': 'Institute of Aging, Seoul National University, Gwanak-gu, Korea (the Republic of).'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Ko', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seongnam, Korea (the Republic of).'}]",BMJ open,['10.1136/bmjopen-2020-038598']
2186,33040092,Attention-deficit/hyperactivity disorder and the explore/exploit trade-off.,"The ability to maximize rewards and minimize the costs of obtaining them is vital to making advantageous explore/exploit decisions. Exploratory decisions are theorized to be greater among individuals with attention-deficit/hyperactivity disorder (ADHD), potentially due to deficient catecholamine transmission. Here, we examined the effects of ADHD status and methylphenidate, a common ADHD medication, on explore/exploit decisions using a 6-armed bandit task. We hypothesized that ADHD participants would make more exploratory decisions than controls, and that MPH would reduce group differences. On separate study days, adults with (n = 26) and without (n = 23) ADHD completed the bandit task at baseline, and after methylphenidate or placebo in counter-balanced order. Explore/exploit decisions were modeled using reinforcement learning algorithms. ADHD participants made more exploratory decisions (i.e., chose options without the highest expected reward value) and earned fewer points than controls in all three study days, and methylphenidate did not affect these outcomes. Baseline exploratory choices were positively associated with hyperactive ADHD symptoms across all participants. These results support several theoretical models of increased exploratory choices in ADHD and suggest the unexplained variance in ADHD decisions may be due to less value tracking. The inability to suppress actions with little to no reward value may be a key feature of hyperactive ADHD symptoms.",2020,Baseline exploratory choices were positively associated with hyperactive ADHD symptoms across all participants.,"['individuals with attention-deficit/hyperactivity disorder (ADHD', 'adults with (n\u2009=\u200926) and without (n\u2009=\u200923) ADHD completed the bandit task at baseline, and after']","['methylphenidate or placebo', 'methylphenidate']","['hyperactive ADHD symptoms', 'exploratory decisions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0517165,Baseline exploratory choices were positively associated with hyperactive ADHD symptoms across all participants.,"[{'ForeName': 'Merideth A', 'Initials': 'MA', 'LastName': 'Addicott', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, AR, USA. maddicott@uams.edu.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Pearson', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Schechter', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Sapyta', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Margaret D', 'Initials': 'MD', 'LastName': 'Weiss', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Kollins', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00881-8']
2187,33040096,Effect of nomophobia on the anxiety levels of undergraduate students.,"OBJECTIVE


The purpose of the study was to investigate the impact of restricting mobile phone use with time on the anxiety levels of undergraduate students having moderate nomophobia. The study also aimed to find whether cognitive and sensory distractions within the environment could delay anxious thoughts and subsequent rise in anxiety levels.
METHODS


Current research was based on a quasi-experimental design with non-equivalent control group, i.e., the participants were not randomly assigned to groups. The participants were 64 undergraduate students taken from a university located in Islamabad. The State trait anxiety inventory (STAI) and Nomophobia questionnaire (NMPQ) were used. The study was carried out between August to December 2017.The data collected was analysed using general linear model to see the significant effect of time and treatment on the state anxiety levels at different time intervals.
RESULTS


The findings from multivariate analysis revealed that the state anxiety increased significantly with time in participants having moderate nomophobia and who were not in contact with their mobile phones as hypothesized. However, cognitive and sensory distractions could only slightly delay the anxiety in fearful situations.
CONCLUSIONS


There is a significant effect of time and nomophobia on anxiety level of students who are separated from their mobile phone within the usual cognitive and sensory distractions in academic setting.",2020,There is a significant effect of time and nomophobia on anxiety level of students who are separated from their mobile phone within the usual cognitive and sensory distractions in academic setting.,"['undergraduate students having moderate nomophobia', 'undergraduate students', 'participants were 64 undergraduate students taken from a university located in Islamabad']",['nomophobia'],"['state anxiety', 'anxiety levels', 'State trait anxiety inventory (STAI) and Nomophobia questionnaire (NMPQ', 'state anxiety levels']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332285', 'cui_str': 'In'}]",[],"[{'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",64.0,0.0209449,There is a significant effect of time and nomophobia on anxiety level of students who are separated from their mobile phone within the usual cognitive and sensory distractions in academic setting.,"[{'ForeName': 'Rija', 'Initials': 'R', 'LastName': 'Mir', 'Affiliation': 'Department of Humanities, COMSATS University Islamabad, Pakistan.'}, {'ForeName': 'Mubeen', 'Initials': 'M', 'LastName': 'Akhtar', 'Affiliation': 'Department of Humanities, COMSATS University Islamabad, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.31286']
2188,33040098,Effect of simulation-based learning on first clinical day stress and anxiety levels of nursing students in Turkey.,"Objectives


To determine the effect of simulation-oriented skills training on first clinical day stress and anxiety levels in nursing students.
METHODS


The quasi-experimental study was conducted from April to June, 2016, in Istanbul, Turkey, and comprised first year nursing students who were divided into two groups. In Group 1, students measured vital signs on simulated patients before their first clinical practice. In Group 2, the students performed this application on each other. Then, on the first day of their clinical practice, the students evaluated the vital signs and then filled out Clinical Stress Questionnaire and the State-Trait Anxiety Inventory. Data was analysed using Number Cruncher Statistical System version 2007.
RESULTS


Of the 41 subjects, 16(39%) were in Group 1 with a mean age of 19.31±3.2 years, and 25(61%) were in Group 2 with a mean age of 18.92±0.86 years (p>0.05). There was no significant differences in state-trait anxiety inventory and clinical stress questionnaire scores between the groups (p>0.05). There was a significant difference with respect to benefit subscale of the clinical stress questioaanire (p=0.049).
CONCLUSIONS


The use of simulation in nursing education provided relief and confidence during clinical practice.",2020,There was no significant differences in state-trait anxiety inventory and clinical stress questionnaire scores between the groups (p>0.05).,"['nursing students in Turkey', 'nursing students', 'Of the 41 subjects, 16(39%) were in Group 1 with a mean age of 19.31±3.2 years, and 25(61%) were in Group 2 with a mean age of 18.92±0.86 years (p>0.05', 'April to June, 2016, in Istanbul, Turkey, and comprised first year nursing students who were divided into two groups']","['simulation-oriented skills training', 'simulation-based learning']","['state-trait anxiety inventory and clinical stress questionnaire scores', 'benefit subscale of the clinical stress questioaanire']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0145137,There was no significant differences in state-trait anxiety inventory and clinical stress questionnaire scores between the groups (p>0.05).,"[{'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Uslu', 'Affiliation': 'Department of Nursing, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.'}, {'ForeName': 'Ela Yilmaz', 'Initials': 'EY', 'LastName': 'Coskun', 'Affiliation': 'Department of Nursing, Tekirdag Nam?k Kemal University, Tekirdag, Turkey.'}, {'ForeName': 'Gizem', 'Initials': 'G', 'LastName': 'Sahin', 'Affiliation': 'Istanbul University Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Ugur', 'Affiliation': 'Acibadem University School of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Ukke', 'Initials': 'U', 'LastName': 'Karabacak', 'Affiliation': 'Acibadem Mehmet Ali Aydinlar University, Faculty of Health Sciences, Nursing Department, Turkey.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.13576']
2189,33040101,Cognitive behaviour therapy for white coat hypertension-causing latrophobia in adults: randomized controlled trial.,"Objective


To see whether cognitive behaviour therapy improves blood pressure-oriented latrophobia in adults to manage white coat hypertension.
METHODS


Present study was conducted at the Kidney Centre, Sialkot, Pakistan from December 2017 to November 2018, and comprised latrophobic attendees of kidney patients without initially exploring the reason of phobia. Either of the intervention or control group was allotted, randomly. The intervention group underwent 20 weekly sessions of the therapy. Pre- and posttherapy systolic blood pressure (at home and medical clinic) of both the groups was recorded alongside self-perceived level of phobia in subjects of only treatment group.
RESULTS


Of 30 subjects of intervention group, 22 (73.3%) completed the therapy. However, control (N = 30) stayed intact. Age statistics were, as: M = 38.2, SD = 11.8, range 20-56 years with male predominance. Moreover, 12 (54.4%) or 20 (90.9%) of them reported severe latrophobia or onset of phobia after childhood, respectively. After therapy, 17 (77.3%) subjects communicated improvement in fear. A significant decline in mean systolic blood pressure was noted in pre- to posttherapy record (149 vs.142 mm of Hg, respectively; t(21)= 8.829, p = 0.0001).
Conclusion


Generally, cognitive behaviour therapy improves blood pressure-oriented latrophobia in adults.",2020,"A significant decline in mean systolic blood pressure was noted in pre- to posttherapy record (149 vs.142 mm of Hg, respectively; t(21)= 8.829, p = 0.0001).
","['adults', 'adults to manage white coat hypertension', 'Present study was conducted at the Kidney Centre, Sialkot, Pakistan from December 2017 to November 2018, and comprised latrophobic attendees of kidney patients without initially exploring the reason of phobia', 'white coat hypertension-causing latrophobia in adults', 'Age statistics were, as: M = 38.2, SD = 11.8, range 20-56 years with male predominance']","['cognitive behaviour therapy', 'Cognitive behaviour therapy']","['mean systolic blood pressure', 'blood pressure-oriented latrophobia', 'fear', 'Pre- and posttherapy systolic blood pressure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0262534', 'cui_str': 'Labile hypertension due to being in a clinical environment'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0349231', 'cui_str': 'Phobia'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",,0.0275786,"A significant decline in mean systolic blood pressure was noted in pre- to posttherapy record (149 vs.142 mm of Hg, respectively; t(21)= 8.829, p = 0.0001).
","[{'ForeName': 'Muhammad Nadeem', 'Initials': 'MN', 'LastName': 'Shafique', 'Affiliation': 'Department of Urology, Sialkot Medical College, Sialkot, Pakistan s.'}, {'ForeName': 'Rana Mozammil', 'Initials': 'RM', 'LastName': 'Shamsher Khan', 'Affiliation': 'Psychiatry and Behavioural Sciences, Khawaja Muhammad Safdar Medical College, Sialkot.'}, {'ForeName': 'Muhammad Saeed', 'Initials': 'MS', 'LastName': 'Razi', 'Affiliation': 'Department of ENT, Government Khawaja Muhammad Safdar Medical College, Sialkot, Pakistan.'}, {'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Muhammad', 'Affiliation': 'Department of Medicines, Sialkot Medical College, Sialkot, Pakistan.'}, {'ForeName': 'Syed Hassan', 'Initials': 'SH', 'LastName': 'Akhtar', 'Affiliation': 'Department of Urology, Government Khawaja Muhammad Safdar Medical College, Sialkot, Pakistan.'}, {'ForeName': 'Mujahid', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Federal Government College, Sialkot Cantt, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.28788']
2190,33040103,Frequency of port site wound infection after Gall Bladder removal with or without retrieval bag in Laparoscopic Cholecystectomy.,"OBJECTIVE


The rationale of the study was to depict the safest method of extracting gallbladder after laparoscopic cholecystectomy to decrease the frequency of wound infection. The objective of the study was to compare the frequency of port site wound infection after gallbladder removal with or without retrieval bag in laparoscopic cholecystectomy.
METHODS


The study design was Randomized Parallel group design conductedin the Department of Surgery, Bahawal Victoria Hospital, Bahawalpur. A total of 254 patients of both gender age range 25-60 years, diagnosed as a case of cholelithiasis by ultrasonography were included. Case sheet of patients were prepared for age, gender, duration of cholelithiasis, operating time and presence or absence of wound infection.
RESULTS


Mean age of patients was 40.77 ± 10.95 years. Out of 254 patients, 98 (38.58%) were males and 156 (61.42%) were females with male to female ratio of 1:2.5. Patients were divided in two groups A and B and the frequency of patients having port site wound infection in group A was 1(0.4%) whereas in group B was 14(5.5%).
CONCLUSIONS


This study concluded that the use of retrieval bag to remove gallbladder in laparoscopic cholecystectomy resulted in decreased frequency of port site wound infection. The insignificant association of port site wound infection with different age groups, gender categories and with duration of cholelithiasis was revealed. Moreover wound infection proved significantly associated with both categories with operating time.",2020,This study concluded that the use of retrieval bag to remove gallbladder in laparoscopic cholecystectomy resulted in decreased frequency of port site wound infection.,"['254 patients of both gender age range 25-60 years, diagnosed as a case of cholelithiasis by ultrasonography were included', 'Mean age of patients was 40.77 ± 10.95 years', '254 patients, 98 (38.58%) were males and 156 (61.42%) were females with male to female ratio of 1:2.5']","['Gall Bladder removal with or without retrieval bag in Laparoscopic Cholecystectomy', 'laparoscopic cholecystectomy', 'gallbladder removal with or without retrieval bag']","['frequency of port site wound infection', 'frequency of wound infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}]",254.0,0.0436862,This study concluded that the use of retrieval bag to remove gallbladder in laparoscopic cholecystectomy resulted in decreased frequency of port site wound infection.,"[{'ForeName': 'Habib Ur', 'Initials': 'HU', 'LastName': 'Rehman', 'Affiliation': 'Victoria Hospital Bahawalpur, Pakistan.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Siddiqa', 'Affiliation': 'Department of Mathematics and Statistics, International Islamic University Islamabad, Pakistan.'}, {'ForeName': 'Attah Ul', 'Initials': 'AU', 'LastName': 'Munam', 'Affiliation': 'District Headquarter Rawalpindi, Pakistan.'}, {'ForeName': 'Shamin', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Victoria Hospital Bahawalpur, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.300311']
2191,33040106,A Randomized controlled study to evaluate the effect of flipped classroom relative to a traditional demonstration method on learning of procedural skills in dermatology residents.,"OBJECTIVE


To assess the effectiveness of flipped classroom on dermatology residents' learning of procedural skills, and to identify their perceptions about it.
Methods


The case-control study was conducted at Dermatology department of Pak Emirates Military and Combined Military Hospital Rawalpindi from 1/3/2018 to 2/7/2018, and comprised post-graduate dermatology residents training at Pak Emirates Military and Combined Military Hospital, Rawalpindi, Pakistan. The residents were randomised into two equal groups. A pre-test consisting of multiple-choice questions was taken. Group A was emailed the related teaching material 1 week prior to the session. The in the subsequent week, both groups attended a 3-hour hands-on training session. In the first hour, Group A had small group discussion, while Group B attended interactive lecture utilising the same teaching material that was posted to Group A earlier. Both groups then participated in hands-on session with the same facilitators. The process was repeated next week for another topic. Finally, a post-test comprising multiple-choice questions and objectively structured clinical exam at 16 stations was conducted. Group A answered the flipped classroom perception instrument and three open-ended questions. Quantitative data was analysed using SPSS 21, while manual thematic analysis was done for qualitative data.
RESULTS


Of the 40 subjects, there were 40(50%) in each of the two groups. There was a significant difference between median pre-test and post-test scores in both groups (p<0.001).. With respect to objectively structured clinical exam, the median score of Group A was significantly different from Group B (p=0.001).
CONCLUSIONS


Flipped classroom was found to be an effective teaching strategy for procedural skills in dermatology residents.",2020,"With respect to objectively structured clinical exam, the median score of Group A was significantly different from Group B (p=0.001).
","['Dermatology department of Pak Emirates Military and Combined Military Hospital Rawalpindi from 1/3/2018 to 2/7/2018, and comprised post-graduate dermatology residents training at Pak Emirates Military and Combined Military Hospital, Rawalpindi, Pakistan', 'dermatology residents', '40 subjects']","['flipped classroom relative to a traditional demonstration method', 'flipped classroom']",['median pre-test and post-test scores'],"[{'cui': 'C0587461', 'cui_str': 'Dermatology department'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0194218,"With respect to objectively structured clinical exam, the median score of Group A was significantly different from Group B (p=0.001).
","[{'ForeName': 'Sakina Sadiq', 'Initials': 'SS', 'LastName': 'Malik', 'Affiliation': 'Department of Dermatology, Combined Military Hospital, Rawalpindi, Pakistan.'}, {'ForeName': 'Rahila', 'Initials': 'R', 'LastName': 'Yasmeen', 'Affiliation': 'Riphah Academy of Research and Education, Riphah International University, Islamabad,Pakistan.'}, {'ForeName': 'Rehan Ahmed', 'Initials': 'RA', 'LastName': 'Khan', 'Affiliation': 'Department of Surgery, Riphah International University, Islamabad, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.27173']
2192,33040112,Assessment of endotracheal intubation procedures following inadvertent esophageal intubation. A randomized crossover manikin trial.,"Objective


To evaluate the success, degree of difficulty and completion time of endotracheal intubation without removing the endotracheal tube in the event of an oesophageal intubation..
METHODS


The prospective, randomised crossover study was conducted at Gulhane Training and Research Hospital, Ankara, Turkey, from July 1, 2018, to August 31, 2018, and used a manikin model. Endotracheal intubation was performed using Miller, Macintosh blades and a video laryngoscope. The procedures were randomised into two groups, with group E+ being subjected to it while an endotracheal tube ETT was placed in the oesophagus (E+) simulating the oesophageal intubation, and control group E- getting the standard procedure without the endotracheal tube in the oesophagus. All methods were evaluated for their success, completion time, and degree of difficulty. Data was analysed using SPSS 22.
RESULTS


There were 120 manikins, with 60(50%) in each of the two groups. The mean completion time with Miller in E+ group was 19.05±9.65 and for E- it was 17.55±11.95 seconds. With Macintosh, E+ had a mean completion time of 19.85±12.66 seconds and E- had 16.75±8.66. With video laryngoscope, E+ group had a mean completion time of 16.75±8.66 seconds, while E- had it 14.60±8.17. No significant difference was found in the paired group comparisons in terms of the degree of task difficulty (p>0.05).
CONCLUSIONS


In case of inadvertent oesophageal intubation condition, leaving the tube in the oesophagus and performing subsequent endotracheal intubation attempts was not found to decrease the rate of success regardless of the laryngoscope type.",2020,"No significant difference was found in the paired group comparisons in terms of the degree of task difficulty (p>0.05).
","['Gulhane Training and Research Hospital, Ankara, Turkey, from July 1, 2018, to August 31, 2018, and used a manikin model', 'inadvertent esophageal intubation']","['E', 'endotracheal intubation procedures', 'endotracheal tube ETT was placed in the oesophagus (E+) simulating the oesophageal intubation, and control group E- getting the standard procedure without the endotracheal tube in the oesophagus', 'video laryngoscope, E', 'endotracheal intubation without removing the endotracheal tube']","['mean completion time', 'degree of task difficulty (p>0.05', 'success, completion time, and degree of difficulty']","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1301920', 'cui_str': 'Inadvertent esophageal intubation'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C2939167', 'cui_str': 'Intubation of esophagus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C1883720', 'cui_str': 'Removes'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",,0.0540474,"No significant difference was found in the paired group comparisons in terms of the degree of task difficulty (p>0.05).
","[{'ForeName': 'Sedat', 'Initials': 'S', 'LastName': 'Bilge', 'Affiliation': 'Department of Emergency Medicine, Gulhane School of Medicine, University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Yahya Ayhan', 'Initials': 'YA', 'LastName': 'Acar', 'Affiliation': 'Department of Emergency Medicine, Gulhane School of Medicine, University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Aydin', 'Affiliation': 'Miaclinics, Atasehir, Istanbul, Turkey.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Tezel', 'Affiliation': 'Department of Emergency Medicine, Gulhane School of Medicine, University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Guclu', 'Initials': 'G', 'LastName': 'Aydin', 'Affiliation': 'Department of Emergency Medicine, Gulhane Training and Research Hospital, University of Health Sciences, Ankara, Turkey.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.56679']
2193,33038782,Effects of chamomile extract nasal drop on chronic rhinosinusitis treatment: A randomized double blind study.,"OBJECTIVES


Recently, more attention has been paid to herbal treatment in chronic rhinosinusitis (CRS) patients. Chamomile (Matrricaria chamomilla) has extensive clinical uses in traditional-Persian medicine for its therapeutic properties. This study aimed to evaluate the effects of chamomile extract on the clinical symptoms of patients with CRS in a university hospital.
MATERIALS AND METHODS


In a randomized double-blind placebo-group clinical trial, 74 CRS patients were examined by an otolaryngologist blinded to the study groups, and the effects of treatment (according to SNOT-22 questionnaire) and possible complications recorded. Statistical analysis performed using SPSS software version 21, and level of significance considered as P < 0.05.
RESULTS


Of the 74 patients (31 females and 43 male), 37 cases randomized in the intervention and 37 cases in the placebo group. The Lund-Mackay score, clinical findings in endoscopic nasal examination and mean score of the SNOT-22 were not significantly different at baseline visit between the two study groups. The adjusted mean score of quality of life during the four time periods in the intervention group (34.3, confidence interval of 95%: 31.8-36.7) was significantly lower than that of control group (45.9, confidence interval of 95%: 43.5-48.4) (P-value = 0.001). Also, clinical improvement in endoscopic nasal examination was significant in intervention group compared with placebo group.
CONCLUSION


Chamomile extract is effective in further reducing the clinical symptoms and improving the quality of life of CRS patients.",2020,Chamomile (Matrricaria chamomilla) has extensive clinical uses in traditional-Persian medicine for its therapeutic properties.,"['74 CRS patients', '74 patients (31 females and 43 male', 'patients with CRS in a university hospital', 'chronic rhinosinusitis treatment', 'chronic rhinosinusitis (CRS) patients']","['chamomile extract nasal drop', 'Chamomile (Matrricaria chamomilla', 'chamomile extract', 'placebo', 'Chamomile extract']","['adjusted mean score of quality of life', 'Lund-Mackay score, clinical findings in endoscopic nasal examination and mean score of the SNOT-22', 'endoscopic nasal examination', 'quality of life']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439963', 'cui_str': 'Chamomile extract'}, {'cui': 'C0991524', 'cui_str': 'Nasal drops'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}]",74.0,0.418448,Chamomile (Matrricaria chamomilla) has extensive clinical uses in traditional-Persian medicine for its therapeutic properties.,"[{'ForeName': 'Shadman', 'Initials': 'S', 'LastName': 'Nemati', 'Affiliation': 'Otorhinolaryngology Research Center, Department of Otolaryngology and Head and Neck Surgery, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Yousefbeyk', 'Affiliation': 'Department of Pharmacognosy, School of Pharmacy, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Seyedeh Matin', 'Initials': 'SM', 'LastName': 'Ebrahimi', 'Affiliation': 'Otorhinolaryngology Research Center, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Ali Faghih', 'Initials': 'AF', 'LastName': 'FaghihHabibi', 'Affiliation': 'Otorhinolaryngology Research Center, Department of Otolaryngology and Head and Neck Surgery, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran. Electronic address: dr.faghih.habibi@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shakiba', 'Affiliation': 'Cardiovascular Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Hedieh', 'Initials': 'H', 'LastName': 'Ramezani', 'Affiliation': 'Otorhinolaryngology Research Center, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102743']
2194,33038832,Effect of omega-3 lcpufa supplementation on maternal fatty acid and oxylipin concentrations during pregnancy.,"INTRODUCTION


Omega-3 long chain polyunsaturated fatty acids (LCPUFA) have been associated with a reduction in risk for preterm birth. However, there is limited understanding of how fatty acids and their bioactive derivatives (oxylipins) change over the course of pregnancy. Here we document the changes in concentration of fatty acids and oxylipins during pregnancy and how fatty acid status and oxylipin concentrations are affected by supplementation with omega-3 LCPUFA. We also investigate the degree to which fatty acid and oxylipin changes across pregnancy are influenced by baseline omega-3 status.
MATERIALS AND METHODS


We profiled the fatty acids in all lipids in dried blood spots (total blood fatty acids) by gas chromatography and free (unesterified) fatty acids and their associated oxylipins in separate dried blood spot samples by LC-MS-MS collected from a random sample of 1263 women with a singleton pregnancy who participated in the ORIP (Omega-3 fats to Reduce the Incidence of Prematurity) trial. ORIP is a double-blind, randomized controlled trial involving 5544 participants and designed to determine the effect of supplementing the diets of pregnant women with omega-3 LCPUFA on the incidence of early preterm birth. Maternal whole blood finger prick samples were collected at baseline (~14 weeks gestation) and at completion of the study intervention period (34 weeks gestation).
RESULTS


The concentration of most total and free polyunsaturated fatty acids and their associated oxylipins declined over the course of pregnancy. Omega-3 LCPUFA supplementation increased total DHA and 7-HDHA and mitigated the decline in free DHA, 4-HDHA and 14-HDHA. The intervention had minimal or no effect on free EPA, LA, AA and their associated oxylipins. Omega-3 LCPUFA supplementation in women with higher omega-3 status at baseline was associated with a significant increase in 7-HDHA and 4-HDHA between the treatment and control whereas there were no differences between groups in 7-HDHA and 4-HDHA in women with intermediate or lower baseline omega-3 status.
CONCLUSION


Our data suggest a differential response with or without omega-3 supplementation for DHA and DHA-derived oxylipins, which may have an important role to play in modulating pregnancy duration. Further work is needed to understand their role, which may allow us to better tailor omega-3 supplementation for preterm birth prevention.",2020,"Omega-3 LCPUFA supplementation increased total DHA and 7-HDHA and mitigated the decline in free DHA, 4-HDHA and 14-HDHA.","['5544 participants', '1263 women with a singleton pregnancy who participated in the ORIP (Omega-3 fats to Reduce the Incidence of Prematurity) trial', 'pregnant women with']","['Omega-3 long chain polyunsaturated fatty acids (LCPUFA', 'omega-3 lcpufa supplementation', 'omega-3 LCPUFA', 'dried blood spots (total blood fatty acids) by gas chromatography and free (unesterified) fatty acids and their associated oxylipins', 'ORIP', 'Omega-3 LCPUFA supplementation']","['incidence of early preterm birth', '7-HDHA and 4-HDHA', 'Maternal whole blood finger prick samples', 'total DHA and 7-HDHA', 'free EPA, LA, AA and their associated oxylipins', 'maternal fatty acid and oxylipin concentrations', 'concentration of most total and free polyunsaturated fatty acids']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008555', 'cui_str': 'Gas chromatography measurement'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",5544.0,0.103295,"Omega-3 LCPUFA supplementation increased total DHA and 7-HDHA and mitigated the decline in free DHA, 4-HDHA and 14-HDHA.","[{'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Best', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Medicine, University of Adelaide, North Terrace, Adelaide SA. Electronic address: karen.best@sahmri.com.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Gibson', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Agriculture, Food and Wine, University of Adelaide, North Terrace, Adelaide SA.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Yelland', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Public Health, University of Adelaide, North Terrace, Adelaide SA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Leemaqz', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gomersall', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Public Health, University of Adelaide, North Terrace, Adelaide SA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Makrides', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Medicine, University of Adelaide, North Terrace, Adelaide SA.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102181']
2195,33038833,"Long-term docosahexaenoic acid (DHA) supplementation in cystic fibrosis patients: a randomized, multi-center, double-blind, placebo-controlled trial.","BACKGROUND


Cystic fibrosis (CF) patients have an alteration in fatty acid (FA) metabolism, associated with increased omega-6 and low omega-3 FA. Previous studies on supplementation with omega-3 FA in CF had contradictory results, and to date there is no evidence to recommend routine use of omega-3 supplements in CF patients. We hypothesized that long-term supplementation with docosahexaenoic acid (DHA) will have beneficial effects in these patients, by reducing pulmonary, systemic and intestinal inflammation.
METHODS


This was a randomized, double-blind, parallel, placebo-controlled trial. CF patients (age >2 months) were randomized to receive a seaweed DHA oil solution (50 mg/Kg/day) or matching placebo for 48 weeks. Primary outcomes were pulmonary (interleukin [IL]-8), systemic (IL-8) and intestinal (calprotectin) inflammatory biomarkers. Secondary outcomes included other pulmonary (IL-1β, IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1β, IL-6) inflammatory biomarkers, as well as clinical outcomes (FEV 1 , pulmonary exacerbations, antibiotic use, nutritional status and quality of life).
RESULTS


Ninety six CF patients, 44 female, age 14.6±11.9 years (48 DHA and 48 placebo) were included. At trial completion, there were no differences in all primary outcomes [serum-IL-8 (p=0.909), respiratory-IL-8 (p=0.384) or fecal calprotectin (p=0.948)], all secondary inflammatory biomarkers, or in any of the clinical outcomes evaluated. There were few adverse events, with similar incidence in both study groups.
CONCLUSION


In this study, long-term DHA supplementation in CF patients was safe, but did not offer any benefit on inflammatory biomarkers, or in clinical outcomes compared with placebo. (NCT01783613).",2020,"Secondary outcomes included other pulmonary (IL-1β, IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1β, IL-6) inflammatory biomarkers, as well as clinical outcomes (FEV 1 , pulmonary exacerbations, antibiotic use, nutritional status and quality of life).
","['cystic fibrosis patients', 'Ninety six CF patients, 44 female, age 14.6±11.9 years (48 DHA and 48', 'Cystic fibrosis (CF) patients', 'CF patients', 'CF patients (age >2 months']","['docosahexaenoic acid (DHA) supplementation', 'seaweed DHA oil solution', 'placebo', 'matching placebo', 'docosahexaenoic acid (DHA']","['serum-IL-8 (p=0.909), respiratory-IL-8 (p=0.384) or fecal calprotectin (p=0.948)], all secondary inflammatory biomarkers', 'pulmonary (IL-1β, IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1β, IL-6) inflammatory biomarkers, as well as clinical outcomes (FEV 1 , pulmonary exacerbations, antibiotic use, nutritional status and quality of life', 'pulmonary (interleukin [IL]-8), systemic (IL-8) and intestinal (calprotectin) inflammatory biomarkers']","[{'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0036500', 'cui_str': 'Macroalgae'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0064833', 'cui_str': 'Leukocyte elastase'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}]",96.0,0.816089,"Secondary outcomes included other pulmonary (IL-1β, IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1β, IL-6) inflammatory biomarkers, as well as clinical outcomes (FEV 1 , pulmonary exacerbations, antibiotic use, nutritional status and quality of life).
","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'López-Neyra', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain. Electronic address: alneyra@salud.madrid.org.'}, {'ForeName': 'Lucrecia', 'Initials': 'L', 'LastName': 'Suárez', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Muñoz', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'de Blas', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ruiz de Valbuena', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Garriga', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Unidad de Fibrosis Quística. Servicio de Endocrinología. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Calvo', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario La Fe. Avinguda de Fernando Abril Martorell, 106. 46026-Valencia. Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Ribes', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario La Fe. Avinguda de Fernando Abril Martorell, 106. 46026-Valencia. Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Girón Moreno', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Neumología. Hospital Universitario La Princesa. Instituto de Investigación Sanitaria La Princesa. Calle de Diego de León, 62. 28006-Madrid. Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Máiz', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Unidad de Fibrosis Quística. Servicio de Neumología. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'González', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Central de Asturias. Av. Roma. 33011-Oviedo. Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bousoño', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Central de Asturias. Av. Roma. 33011-Oviedo. Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Manzanares', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Doce de Octubre. Avda. de Córdoba. 28041-Madrid. Spain.'}, {'ForeName': 'Óscar', 'Initials': 'Ó', 'LastName': 'Pastor', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Servicio de Bioquímica Clínica, UCA-CCM. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martínez-Botas', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain; Servicio de Bioquímica-Investigación. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Del Campo', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Servicio de Microbiología, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Cantón', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Servicio de Microbiología, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Garbiñe', 'Initials': 'G', 'LastName': 'Roy', 'Affiliation': 'Servicio de Inmunología, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Menacho', 'Affiliation': 'Servicio de Bioquímica Clínica, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Arroyo', 'Affiliation': 'Unidad de Bioestadística Clínica, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Zamora', 'Affiliation': 'Unidad de Bioestadística Clínica, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain.'}, {'ForeName': 'Joan B', 'Initials': 'JB', 'LastName': 'Soriano', 'Affiliation': 'Hospital Universitario La Princesa. Universidad Autónoma de Madrid. Calle de Diego de León, 62. 28006-Madrid. Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain.'}, {'ForeName': 'Adelaida', 'Initials': 'A', 'LastName': 'Lamas', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102186']
2196,33038262,Choir singing improves respiratory muscle strength and quality of life in patients with structural heart disease - HeartChoir: a randomised clinical trial.,"AIMS OF THE STUDY


Most patients with reduced exercise capacity and acquired or congenital structural heart disease also have a reduced respiratory muscle strength. The aim of this pilot study was to investigate whether choir singing in combination with respiratory muscle training positively influences respiratory muscle strength, exercise capacity and quality of life in this population.
METHODS


In this single-centre, randomised and open-label interventional study we compared respiratory muscle strength, exercise capacity and quality of life in patients with acquired or congenital structural heart disease who received either standard of care and a 12-week intervention (weekly choir rehearsal and daily breathing exercises) or standard of care alone. The primary endpoint was the difference in change in maximum inspiratory pressure (∆MIP%predicted). Secondary endpoints included the difference in change in maximum expiratory pressure (∆MEP%predicted), exercise capacity quantified as maximal oxygen uptake during exercise (∆MVO2%predicted) and quality of life quantified by the Minnesota living with heart failure questionnaire (∆MLHFQ score).
RESULTS


Overall 24 patients (mean age 65, standard deviation [SD] 19 years, 46% male) were randomised after exclusion. ∆MIP%predicted was significantly higher in the intervention group (∆MIP%predicted +14, SD 21% vs &minus;14, SD 23%; p = 0.008) and quality of life improved significantly (∆MLHFQ score &minus;5, SD 6 vs 3, SD 5; p = 0.006) after 12 weeks. ∆MEP%predicted and ∆MVO2%predicted did not differ between both groups (∆MEP%predicted &minus;3, SD 26% vs &minus;3, SD 16%; p = 1.0 and ∆MVO2%predicted 18, SD 12% vs 10, SD 15%; p = 0.2).
CONCLUSIONS


Choir singing in combination with respiratory muscle training improved respiratory muscle strength and quality of life in patients with structural heart disease and may therefore be valuable supplements in cardiac rehabilitation. (Clinical trial registration number: NCT03297918) &nbsp.",2020,"∆MIP%predicted was significantly higher in the intervention group (∆MIP%predicted +14, SD 21% vs &minus;14, SD 23%; p = 0.008) and quality of life improved significantly (∆MLHFQ score &minus;5, SD 6 vs 3, SD 5; p = 0.006) after 12 weeks.","['19 years, 46% male', 'patients with structural heart disease - HeartChoir', 'patients with acquired or congenital structural heart disease who received either', 'Overall 24 patients (mean age 65, standard deviation [SD', 'Most patients with reduced exercise capacity and acquired or congenital structural heart disease', 'patients with structural heart disease']","['Choir singing in combination with respiratory muscle training', 'standard of care and a 12-week intervention (weekly choir rehearsal and daily breathing exercises) or standard of care alone', 'choir singing in combination with respiratory muscle training', 'Choir singing']","['change in maximum expiratory pressure (∆MEP%predicted), exercise capacity quantified as maximal oxygen uptake during exercise (∆MVO2%predicted) and quality of life quantified by the Minnesota living with heart failure questionnaire (∆MLHFQ score', 'maximum inspiratory pressure (∆MIP%predicted', 'respiratory muscle strength and quality of life', '∆MEP%predicted and ∆MVO2%predicted', 'quality of life', 'respiratory muscle strength, exercise capacity and quality of life']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}]","[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0232022', 'cui_str': 'Peak expiratory pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}]",,0.235722,"∆MIP%predicted was significantly higher in the intervention group (∆MIP%predicted +14, SD 21% vs &minus;14, SD 23%; p = 0.008) and quality of life improved significantly (∆MLHFQ score &minus;5, SD 6 vs 3, SD 5; p = 0.006) after 12 weeks.","[{'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Ganzoni', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Ketina', 'Initials': 'K', 'LastName': 'Arslani', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Switzerland / Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, Switzerland.'}, {'ForeName': 'Otmar', 'Initials': 'O', 'LastName': 'Pfister', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Freese', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Switzerland / Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, Switzerland.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Strobel', 'Affiliation': 'Department of Pneumology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mueller', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Switzerland / Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tobler', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Switzerland.'}]",Swiss medical weekly,['10.4414/smw.2020.20346']
2197,33038501,Protocol of a randomized trial of acceptance and commitment therapy for fatigue interference in metastatic breast cancer.,"Fatigue interference with activities, mood, and cognition is one of the most prevalent and distressing concerns of metastatic breast cancer patients. To date, there are no evidence-based interventions for reducing fatigue interference in metastatic breast cancer and other advanced cancer populations. In pilot studies, Acceptance and Commitment Therapy (ACT) has shown potential for reducing symptom-related suffering in cancer patients. The current Phase II trial seeks to more definitively examine the efficacy of telephone-based ACT for women with metastatic breast cancer who are experiencing fatigue interference. In this trial, 250 women are randomly assigned to either the ACT intervention or an education/support control condition. Women in both conditions attend six weekly 50-min telephone sessions. The primary aim of this study is to test the effect of telephone-based ACT on fatigue interference. Secondary outcomes include sleep interference, engagement in daily activities, and quality of life. Outcomes are assessed at baseline, 2 weeks post-intervention, and 3 and 6 months post-intervention. This trial also examines whether increases in psychological flexibility, defined as full awareness of the present moment while persisting in behaviors aligned with personal values, account for the beneficial effect of ACT on fatigue interference. After demonstrating ACT's efficacy, the intervention can be widely disseminated to clinicians who care for metastatic breast cancer patients. Our findings will also inform future ACT trials with various cancer populations and functional outcomes.",2020,"In pilot studies, Acceptance and Commitment Therapy (ACT) has shown potential for reducing symptom-related suffering in cancer patients.","['250 women', 'women with metastatic breast cancer who are experiencing fatigue interference', 'metastatic breast cancer', 'cancer patients', 'metastatic breast cancer patients', 'metastatic breast cancer and other advanced cancer populations']","['telephone-based ACT', 'Acceptance and Commitment Therapy (ACT', 'acceptance and commitment therapy', 'ACT intervention or an education/support control condition']","['sleep interference, engagement in daily activities, and quality of life', 'psychological flexibility', 'Fatigue interference with activities, mood, and cognition', 'fatigue interference']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",250.0,0.0784595,"In pilot studies, Acceptance and Commitment Therapy (ACT) has shown potential for reducing symptom-related suffering in cancer patients.","[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Mosher', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, 402 North Blackford Street, LD 124, Indianapolis, IN 46202, USA. Electronic address: cemosher@iupui.edu.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Krueger', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, 402 North Blackford Street, LD 124, Indianapolis, IN 46202, USA. Electronic address: efkruege@iu.edu.'}, {'ForeName': 'Adam T', 'Initials': 'AT', 'LastName': 'Hirsh', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, 402 North Blackford Street, LD 124, Indianapolis, IN 46202, USA. Electronic address: athirsh@iupui.edu.'}, {'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana Cancer Pavilion, 535 Barnhill Drive, Suite 473, Indianapolis, IN 46202, USA. Electronic address: kathmill@iu.edu.'}, {'ForeName': 'Tarah J', 'Initials': 'TJ', 'LastName': 'Ballinger', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana Cancer Pavilion, 535 Barnhill Drive, Suite 473, Indianapolis, IN 46202, USA. Electronic address: tarahb@iu.edu.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Storniolo', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana Cancer Pavilion, 535 Barnhill Drive, Suite 473, Indianapolis, IN 46202, USA. Electronic address: astornio@iu.edu.'}, {'ForeName': 'Bryan P', 'Initials': 'BP', 'LastName': 'Schneider', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana Cancer Pavilion, 535 Barnhill Drive, Suite 473, Indianapolis, IN 46202, USA. Electronic address: bpschnei@iu.edu.'}, {'ForeName': 'Erin V', 'Initials': 'EV', 'LastName': 'Newton', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana Cancer Pavilion, 535 Barnhill Drive, Suite 473, Indianapolis, IN 46202, USA. Electronic address: evnewton@iu.edu.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Champion', 'Affiliation': 'Indiana University School of Nursing, 1111 Middle Drive, NU 340G, Indianapolis, IN 46202, USA. Electronic address: vchampio@iu.edu.'}, {'ForeName': 'Shelley A', 'Initials': 'SA', 'LastName': 'Johns', 'Affiliation': 'Indiana University School of Medicine, Center for Health Services Research, Regenstrief Institute, 1101 W. 10(th) Street, Indianapolis, IN 46202, USA. Electronic address: sheljohn@iu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106168']
2198,33038677,Rethink Vape: Development and evaluation of a risk communication campaign to prevent youth E-cigarette use.,"INTRODUCTION


E-cigarettes are now the most common form of tobacco use among adolescents, and use is associated with increased risk of initiation of cigarette smoking. This project used a community-engaged research process to develop and pilot a risk communication campaign to prevent youth vaping.
METHOD


The research team worked with a 36-member Teen Advisory Council and a 19-member Expert Panel. Together, the team employed survey (N = 674) and focus group (N = 82) methodologies, and hired a marketing company to partner on development of the campaign. Campaign concepts were developed, eliminated, and/or modified through an iterative process of feedback and refinement. The final campaign included video ads (https://bit.ly/2QMR8gH) a microsite (rethinkvape.org), and social media sites (@rethinkvape). The campaign communicated three messages to teens: what's in the vapor, health risks, and connections to big tobacco. Prior to launch of the campaign, a randomized controlled 2 (time) × 2 (group) online experiment was conducted to evaluate the campaign (N = 268).
RESULTS


Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change. Following evaluation, the team launched a 6-week online media campaign with a teen-targeted geo-fence radius to deliver 3,838,465 impressions, 770,443 completed video views, and 18,316 clicks in mobile app, Snapchat, YouTube, and Spotify platforms. The majority of placements exceeded industry standards, with mobile pre-roll and Snapchat as top performers.
CONCLUSIONS


The e-cigarette campaign showed promising signs of effectiveness and scalability.",2020,"RESULTS


Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change.",[],['Rethink Vape'],"['vaping knowledge, perceptions of risk, and anti-vape intentions', 'video ads (https://bit.ly/2QMR8gH) a microsite (rethinkvape.org), and social media sites (@rethinkvape']",[],"[{'cui': 'C0291011', 'cui_str': 'VAPE protocol'}]","[{'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0291011', 'cui_str': 'VAPE protocol'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",770443.0,0.0316952,"RESULTS


Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change.","[{'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'England', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States. Electronic address: englankj@evms.edu.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Edwards', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Paulson', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Libby', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Harrell', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Mondejar', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106664']
2199,33038685,Intrinsic foot muscle strengthening exercises with electromyographic biofeedback achieve increased toe flexor strength in older adults: A pilot randomized controlled trial.,"BACKGROUND


Toe flexor strength is important for preventing older adults from falling. Although intrinsic foot muscles are the main determinants of toe flexor strength, exercises for strengthening these muscles are difficult for older adults. This study therefore aimed to determine whether the use of electromyographic biofeedback helps older adults to perform intrinsic foot muscle strengthening exercises.
METHODS


This randomized controlled trial had two parallel arms. Participants were randomly allocated to the control group or the electromyographic biofeedback group. Control participants performed two progressive intrinsic foot muscle strengthening exercises twice a week for 6 weeks. Participants in the other group performed these exercises assisted by electromyographic biofeedback. Primary outcome measures were changes in toe flexor strength and the timed up-and-go and functional reach tests (the latter two being balance tests).
FINDINGS


Altogether, 23 older adults were randomized to the control group (n = 12) or the electromyographic biofeedback group (n = 11). After the 6-week intervention, toe flexor strength on the dominant side increased in both groups (P < 0.017). However, toe flexor strength on the nondominant side increased only in the electromyographic biofeedback group (P < 0.017), with a large effect size of 1.5. There were no changes in the two balance tests. Three of the control group and two of the electromyographic biofeedback group were lost to follow- up.
INTERPRETATION


Our results indicate that, the use of electromyographic biofeedback can enhance the effect of intrinsic foot muscle strengthening exercises on the nondominant side in older adults.
CLINICAL TRIAL REGISTRATION NUMBER


UMIN000036521.",2020,"However, toe flexor strength on the nondominant side increased only in the electromyographic biofeedback group (P < 0.017), with a large effect size of 1.5.","['older adults', 'older adults from falling', '23 older adults']","['electromyographic biofeedback', 'exercises assisted by electromyographic biofeedback', 'progressive intrinsic foot muscle strengthening exercises', 'Intrinsic foot muscle strengthening exercises with electromyographic biofeedback', 'electromyographic biofeedback group']","['toe flexor strength on the nondominant side', 'toe flexor strength', 'changes in toe flexor strength and the timed up-and-go and functional reach tests (the latter two being balance tests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]","[{'cui': 'C0204624', 'cui_str': 'Electromyographic biofeedback'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0581753', 'cui_str': 'Muscle structure of foot'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",23.0,0.0409907,"However, toe flexor strength on the nondominant side increased only in the electromyographic biofeedback group (P < 0.017), with a large effect size of 1.5.","[{'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Okamura', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan. Electronic address: k-okamura@pu-hiroshima.ac.jp.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Egawa', 'Affiliation': 'Graduate School of Comprehensive Scientific Research, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan; Okii Clinic, 4-5-10 Motomachi, Iwakuni, Yamaguchi 740-0012, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Okii', 'Affiliation': 'Okii Clinic, 4-5-10 Motomachi, Iwakuni, Yamaguchi 740-0012, Japan.'}, {'ForeName': 'Sadaaki', 'Initials': 'S', 'LastName': 'Oki', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan. Electronic address: oki@pu-hiroshima.ac.jp.'}, {'ForeName': 'Shusaku', 'Initials': 'S', 'LastName': 'Kanai', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan. Electronic address: kanai@pu-hiroshima.ac.jp.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105187']
2200,33040810,Effects of Floium ginkgo extract and tertram ethypyrazine sodium chloride injection on expression of inflammatory cytokines and cerebral infarction.,"This experiment was carried out to observe and analyze the effect of floium ginkgo extract and tertram ethypyrazine sodium chloride injection in patients with cerebral infarction. A total of 200 patients diagnosed with cerebral infarction were enrolled in the study. They were randomly divided into a research group and control group, each containing 100 patients. The control group was given routine treatment measures while the research group was given floium ginkgo extract and tertram ethypyrazine sodium chloride injection on the basis of routine treatment. The therapeutic effects of the two groups were observed and compared. After implementing different treatment schemes, the levels of MMP-9, SOD, CBV and CBF in the research group were significantly higher than those in the control group, p&lt;0.05. The research group was lower in hs-CRP, MDA, MTT, TTP and TNF-α as compared with the control group, p&lt;0.05. In terms of the quality of life of the two groups after six months of treatment, the scores of various indicators in the research group were all significantly superior, p&lt;0.05. Conclusion: The treatment of cerebral infarction patients with floium ginkgo extract and tertram ethypyrazine sodium chloride injection can significantly improve the therapeutic effect, which is a relatively ideal treatment.",2020,"The research group was lower in hs-CRP, MDA, MTT, TTP and TNF-α as compared with the control group, p&lt;0.05.","['cerebral infarction patients with', 'patients with cerebral infarction', '200 patients diagnosed with cerebral infarction']","['Floium ginkgo extract and tertram ethypyrazine sodium chloride injection', 'floium ginkgo extract and tertram ethypyrazine sodium chloride injection']","['therapeutic effect', 'therapeutic effects', 'levels of MMP-9, SOD, CBV and CBF', 'expression of inflammatory cytokines and cerebral infarction', 'quality of life']","[{'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0772125', 'cui_str': 'Ginkgo biloba extract'}, {'cui': 'C4282818', 'cui_str': 'Sodium Chloride Injection'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0054917', 'cui_str': 'CBV protocol'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",200.0,0.0137364,"The research group was lower in hs-CRP, MDA, MTT, TTP and TNF-α as compared with the control group, p&lt;0.05.","[{'ForeName': 'Qingna', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Chunhui', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': ''}, {'ForeName': 'Jingyan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Dong', 'Affiliation': ''}]","Cellular and molecular biology (Noisy-le-Grand, France)",[]
2201,33040813,"Effects of sevoflurane inhalation anesthesia on IL-6, TNF-α and MMP-9 expression and hemodynamics in elderly patients undergoing lobectomy for lung cancer.","Objective of current research was to investigate the effect of sevoflurane inhalation anesthesia on hemodynamics and inflammatory response in elderly patients with lung cancer lobectomy. Methods: A total of 168 patients with lung cancer who underwent lobectomy in our hospital from January 2019 to December 2019 were selected as the study subjects. The patients were divided into an observation group and control group according to the anesthesia program. In the control group, 1 mg/kg propofol intravenous pump induced anesthesia was maintained at 6mg/kg/h. In the observation group, 8% sevoflurane was used to induce anesthesia and 2% sevoflurane was used to maintain anesthesia. Mean artery pressure (MAP), heart rate (HR) and blood oxygen saturation (SpO2) were monitored at the beginning of single-lung ventilation (t1), when single-lung ventilation was changed to double-lung ventilation (t2), and at 30 minutes after double-lung ventilation (t3), respectively. Serum levels of interleukin-6 (IL-6), tumor necrosis factor (TNF-α), and matrix metalloproteinases (MMP-9) were measured using an enzyme-linked immunosorbent assay (ELISA) kit. Assess the patient's adverse reactions. Results: At time t1 and time t2, there was no significant difference in the three hemodynamic indicators between the two groups (P&gt;0.05). However, at t3, both MAP and HR in the observation group were significantly lower than those in the control group, while SpO2 was significantly higher than those in the control group (P&lt;0.05). At t1 and t2, there was no significant difference in IL-6 and TNF- levels between the two groups, but at t3, IL-6 and TNF-α levels in the observation group were significantly lower than those in the control group (P&lt;0.05). Compared with the control group, serum MMP-9 level was significantly decreased in the whole t1 to t3 stage (P&lt;0.05). The incidence of complications in the observation group was significantly higher than that in the control group. It was calculated that Sevoflurane can significantly improve hemodynamics and inflammatory response in elderly patients with lung cancer lobectomy, but the incidence of complications is high.",2020,"Serum levels of interleukin-6 (IL-6), tumor necrosis factor (TNF-α), and matrix metalloproteinases (MMP-9) were measured using an enzyme-linked immunosorbent assay (ELISA) kit.","['elderly patients with lung cancer lobectomy', 'elderly patients undergoing lobectomy for lung cancer', '168 patients with lung cancer who underwent lobectomy in our hospital from January 2019 to December 2019 were selected as the study subjects']","['sevoflurane inhalation anesthesia', 'Sevoflurane', 'sevoflurane']","['hemodynamic indicators', 'IL-6, TNF-α and MMP-9 expression and hemodynamics', 'hemodynamics and inflammatory response', 'IL-6 and TNF-α levels', 'SpO2', 'incidence of complications', 'Mean artery pressure (MAP), heart rate (HR) and blood oxygen saturation (SpO2', 'MAP and HR', 'IL-6 and TNF- levels', 'serum MMP-9 level', 'Serum levels of interleukin-6 (IL-6), tumor necrosis factor (TNF-α), and matrix metalloproteinases (MMP-9']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002917', 'cui_str': 'Anesthesia, Inhalation'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}]",168.0,0.0250707,"Serum levels of interleukin-6 (IL-6), tumor necrosis factor (TNF-α), and matrix metalloproteinases (MMP-9) were measured using an enzyme-linked immunosorbent assay (ELISA) kit.","[{'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Fujian Medical University, Fujian, 350005, China.'}, {'ForeName': 'Minjie', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Rujie', 'Initials': 'R', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Fujian Medical University, Fujian, 350005, China.'}, {'ForeName': 'Qinfeng', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Fujian Medical University, Fujian, 350005, China.'}, {'ForeName': 'Yanzhen', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Fujian Medical University, Fujian, 350005, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Ningde City Hospital Affiliated to Fujian Medical University, Fujian, 352000, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Fuzhou Center for Disease Control and Prevention, Fujian, 350005, China.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Fuzhou Center for Disease Control and Prevention, Fujian, 350005, China.'}]","Cellular and molecular biology (Noisy-le-Grand, France)",[]
2202,33040814,"Effects of oral desloratadine citrate disodium combined with physiological seawater nasal irrigation on IgE levels, IL-4, IL-6, IL-13 and IFN-γ expression and treatment of intermittent allergic rhinitis.","This experiment was performed to explore the effect of oral desloratadine citrate disodium combined with physiological seawater nasal irrigation in the treatment of intermittent allergic rhinitis and its effect on serum inflammatory factors and peripheral blood Th1 and Th2. For this purpose, 100 patients of intermittent allergic rhinitis admitted to our hospital from January 2018 to January 2020. Randomly divided into a control group (n=50) and an observation group (n=50). The control group was given oral desloratadine citrate disodium. The observation group was given physiological seawater nasal irrigation based on the control group. Both groups were treated for one month. Compare the effect of treatment, symptom and sign scores pre and posttreatment, serum immunoglobulin E (IgE) levels, serum interleukin 4 (IL-4), IL-6, IL-13 and interferon-gamma (IFN-γ) levels, peripheral blood helper T cells 1 (Th1) and Th2 and the recurrence rate of patients after 1 year between two groups. Results showed that after one month of continuous treatment, the total effective rate of the observation group was significantly higher than that of the control group (P &lt;0.05). The symptoms and signs scores and serum IgE levels of the two groups pretreatment (before treatment) were not significantly different (P &gt; 0.05). The symptoms and signs scores and serum IgE levels of the two groups decreased significantly posttreatment (after treatment) (P &lt;0.05), and the observation group was significantly lower than the control group (P &lt;0.05). Pretreatment, the levels of serum inflammatory factors (IL-4, IL-6, IL-13, and IFN-γ) and the ratio of peripheral blood Th1 and Th2 to CD4+T cells were not significantly different (P&gt; 0.05). After one month of continuous treatment, the levels of serum IL-4, IL-6, IL-13, and the ratio of peripheral blood CD4+IL-4+/CD4+ in the observation group and the control group were significantly reduced and the ratio of CD4+IFN-γ+/CD4+ was significantly increased (P &lt;0.05). Compared with the control group, those changes were more obvious in the observation group (P &lt;0.05). The one-year recurrence rate of the observation group was 4% (2/50), which was significantly lower than that of the control group, which was 20% (10/50). There was a statistical difference between the two groups (P &lt;0.05). It was concluded that oral desloratadine citrate disodium combined with physiological seawater nasal irrigation can effectively improve the symptoms and signs of intermittent allergic rhinitis and reduce the recurrence rate. This may be related to balancing T cell responses, promoting systemic Th1 responses and inhibiting Th2 responses, and down-regulating inflammatory response.",2020,The symptoms and signs scores and serum IgE levels of the two groups decreased significantly posttreatment (after treatment),['100 patients of intermittent allergic rhinitis admitted to our hospital from January 2018 to January 2020'],"['oral desloratadine citrate disodium combined with physiological seawater nasal irrigation', 'desloratadine citrate disodium combined with physiological seawater nasal irrigation', 'desloratadine citrate disodium']","['symptoms and signs of intermittent allergic rhinitis', 'symptoms and signs scores and serum IgE levels', 'total effective rate', 'levels of serum inflammatory factors (IL-4, IL-6, IL-13, and IFN-γ) and the ratio of peripheral blood Th1 and Th2 to CD4+T cells', 'symptom and sign scores pre and posttreatment, serum immunoglobulin E (IgE) levels, serum interleukin 4 (IL-4), IL-6, IL-13 and interferon-gamma (IFN-γ) levels, peripheral blood helper T cells 1 (Th1) and Th2 and the recurrence rate', 'ratio of CD4+IFN-γ+/CD4', 'IgE levels, IL-4, IL-6, IL-13 and IFN-γ expression and treatment of intermittent allergic rhinitis', 'recurrence rate', 'levels of serum IL-4, IL-6, IL-13, and the ratio of peripheral blood CD4+IL-4+/CD4']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0252352', 'cui_str': 'des(ethoxycarbonyl)loratadine'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036499', 'cui_str': 'Sea Water'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}]","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0856520', 'cui_str': 'Serum immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0214743', 'cui_str': 'Interleukin 13'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0018894', 'cui_str': 'Helper cell'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.0205313,The symptoms and signs scores and serum IgE levels of the two groups decreased significantly posttreatment (after treatment),"[{'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery, Jining NO.1 People's Hospital, Jining, 272000, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery, Jining NO.1 People's Hospital, Jining, 272000, China.""}]","Cellular and molecular biology (Noisy-le-Grand, France)",[]
2203,33040817,Application of dexmedetomidine combined with ropivacaine in axillary brachial plexus block in children and its effect on inflammatory factors.,"This study aimed to investigate the effect of dexmedetomidine combined with ropivacaine on inflammatory factors in children with axillary brachial plexus block. Ninety patients who underwent upper limb surgery in our hospital from January 2017 to December 2018 were enrolled and divided into groups A and B. Group A (n=40) was treated with ropivacaine as a local anesthetic, and group B (n= 50) was treated with dexmedetomidine combined with ropivacaine as a local anesthetic during surgery. Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Assessment Scale was employed to evaluate the pain behavior of the children. Intravenous blood (3 ml) was taken before surgery (T0), 30 min (T1) and 3 hours after surgery (T2) respectively to detect serum TNF-α (tumor necrosis factor-α), IL-6 (interleukin-6) and IL-1β (interleukin-1β) levels using ELISA. The adverse reactions in the two groups were observed, and the MAP (mean arterial pressure) and HR (heart rate) were compared before anesthesia, 30 min and 1 hour after block. The FLACC score of both groups showed a marked upward trend (p&lt; 0.001), with that of group B being significantly lower than group A (p&lt; 0.001). Group B presented a remarkably shorter onset time than group A, and the analgesic time was significantly longer (p&lt; 0.001). The incidence of adverse reactions in group B was significantly lower than that in group A (p&lt; 0.05). MAP and HR dropped significantly 30 min and 1 h after block (p&lt; 0.05). MAP and HR were significantly lower in group B than those in group A 30 min and 60 min after block (p&lt; 0.05). As to serum levels of TNF-α, IL-6, and IL-1β, both groups presented notably increased ones after block (p&lt; 0.05). The application of dexmedetomidine combined with ropivacaine in upper limb surgery has a faster onset time and longer duration than ropivacaine alone, which is of certain clinical effect.",2020,"The application of dexmedetomidine combined with ropivacaine in upper limb surgery has a faster onset time and longer duration than ropivacaine alone, which is of certain clinical effect.","['children with axillary brachial plexus block', 'Ninety patients who underwent upper limb surgery in our hospital from January 2017 to December 2018']","['dexmedetomidine combined with ropivacaine', 'ropivacaine', 'dexmedetomidine']","['Face, Legs, Activity, Cry, Consolability (FLACC', 'adverse reactions', 'serum levels of TNF-α, IL-6, and IL-1β', 'IL-6 (interleukin-6) and IL-1β (interleukin-1β) levels', 'inflammatory factors', 'FLACC score', 'incidence of adverse reactions', 'pain behavior', 'analgesic time', 'Behavioral Pain Assessment Scale', 'shorter onset time', 'MAP and HR', 'axillary brachial plexus block', 'MAP (mean arterial pressure) and HR (heart rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0394701', 'cui_str': 'Brachial plexus block by axillary approach'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0394701', 'cui_str': 'Brachial plexus block by axillary approach'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",90.0,0.0361031,"The application of dexmedetomidine combined with ropivacaine in upper limb surgery has a faster onset time and longer duration than ropivacaine alone, which is of certain clinical effect.","[{'ForeName': 'Haikou', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ""Department of Anesthesiology, Maternal & Child Health Care Hospital of Huai'an City, The Affiliated Hospital of Yangzhou University, Huai'an 223000, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': ""Department of Anesthesiology, The Affiliated Huaian NO.1 People's Hospital of Nanjing Medical University, Huai'an 223000, China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Anesthesiology, Maternal & Child Health Care Hospital of Huai'an City, The Affiliated Hospital of Yangzhou University, Huai'an 223000, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': ""Department of Anesthesiology, Maternal & Child Health Care Hospital of Huai'an City, The Affiliated Hospital of Yangzhou University, Huai'an 223000, China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Maternal & Child Health Care Hospital of Huai'an City, The Affiliated Hospital of Yangzhou University, Huai'an 223000, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology, Maternal & Child Health Care Hospital of Huai'an City, The Affiliated Hospital of Yangzhou University, Huai'an 223000, China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Huai'an of Traditional Chinese Medicine, Huai'an 223000, China.""}]","Cellular and molecular biology (Noisy-le-Grand, France)",[]
2204,33040948,The effectivity of trigger point dry needling in improving pain on people with upper trapezius myalgia.,"OBJECTIVE


This study aims to determine the effectivity of dry needling added to the standard treatment to improve pain in patients with upper trapezius myalgia.
METHODS


This study is a randomized controlled trial conducted at Inco Hospital, Sorowako, South Sulawesi, Indonesia, involving 20 subjects who met the inclusion and exclusion criteria. Subjects were divided into two equal groups. The intervention group was treated with dry needling as the addition to standard care, and the control group was treated with standard care only. Both groups were treated three times a week for five weeks. The pain was measured using NPRS at baseline and after three times therapy for five weeks.
RESULTS


At the end of therapy, both groups showed a decrease in pain perception compared to baseline. The pain was improved significantly better in the intervention group compared to the control group.
CONCLUSION


The addition of dry needling in the standard care of upper trapezius myalgia resulted in more effective pain improvement compared to usual care.",2020,"The pain was improved significantly better in the intervention group compared to the control group.
","['at Inco Hospital, Sorowako, South Sulawesi, Indonesia, involving 20 subjects who met the inclusion and exclusion criteria', 'people with upper trapezius myalgia', 'patients with upper trapezius myalgia']","['dry needling as the addition to standard care, and the control group was treated with standard care only', 'trigger point dry needling']","['effective pain improvement', 'pain perception', 'pain']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0376188', 'cui_str': 'Sulawesi'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",20.0,0.037659,"The pain was improved significantly better in the intervention group compared to the control group.
","[{'ForeName': 'Djohan', 'Initials': 'D', 'LastName': 'Aras', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Hasanuddin University, Indonesia. Electronic address: djohanaras.da@gmail.com.'}, {'ForeName': 'Ibtisam Mangputri', 'Initials': 'IM', 'LastName': 'Al-Ihsan', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Hasanuddin University, Indonesia.'}, {'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Sutono', 'Affiliation': 'Department of Physiotherapy, Hasanuddin University Hospital, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.06.020']
2205,33041014,Automated closed-loop versus manually controlled norepinephrine infusion in patients undergoing intermediate- to high-risk abdominal surgery: a randomised controlled trial.,"BACKGROUND


Hypotension occurs frequently during surgery and may be associated with adverse complications. Vasopressor titration is frequently used to correct hypotension, but requires considerable time and attention, potentially reducing the time available for other clinical duties. To overcome this issue, we have developed a closed-loop vasopressor (CLV) controller to help correct hypotension more efficiently. The aim of this randomised controlled study was to evaluate whether the CLV controller was superior to traditional vasopressor management at minimising hypotension in patients undergoing abdominal surgery.
METHODS


Thirty patients scheduled for elective intermediate-to high-risk abdominal surgery were randomised into two groups. In the CLV group, hypotension was corrected automatically via the CLV controller system, which adjusted the rate of a norepinephrine infusion according to MAP values recorded using an advanced haemodynamic device. In the control group, management of hypotension consisted of standard, manual adjustment of the norepinephrine infusion. The primary outcome was the percentage of time that a patient was hypotensive, defined as MAP <90% of their baseline value, during surgery.
RESULTS


The percentage of time patients were hypotensive during surgery was 10 times less in the CVL group than in the control group (1.6 [0.9-2.3]% vs 15.4 [9.9-24.3]%; difference: 13 [95% confidence interval: 9-19]; P<0.0001). The CVL group also spent much less time with MAP <65 mm Hg (0.2 [0.0-0.4]% vs 4.5 [1.1-7.9]%; P<0.0001).
CONCLUSIONS


In patients undergoing intermediate- to high-risk surgery under general anaesthesia, computer-assisted adjustment of norepinephrine infusion significantly decreases the incidence of hypotension compared with manual control.
CLINICAL TRIAL REGISTRATION


NCT04089644.",2020,The CVL group also spent much less time with MAP,"['patients undergoing intermediate- to high-risk abdominal surgery', 'patients undergoing intermediate- to high-risk surgery under general anaesthesia', 'patients undergoing abdominal surgery', 'Thirty patients scheduled for elective intermediate-to high-risk abdominal surgery']","['CLV controller', 'norepinephrine infusion', 'CVL', 'Automated closed-loop versus manually controlled norepinephrine infusion', 'closed-loop vasopressor (CLV) controller', 'MAP']","['hypotensive during surgery', 'hypotension', 'incidence of hypotension', 'percentage of time that a patient was hypotensive']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024779', 'cui_str': 'Maps'}]","[{'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",30.0,0.171251,The CVL group also spent much less time with MAP,"[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Joosten', 'Affiliation': 'Department of Anaesthesiology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium; Department of Anaesthesiology and Intensive Care, Hôpitaux Universitaires Paris-Sud, Université Paris-Sud, Université Paris-Saclay, Hôpital De Bicêtre, Assistance Publique Hôpitaux de Paris, Le Kremlin-Bicêtre, France. Electronic address: Alexandre.Joosten@erasme.ulb.ac.be.'}, {'ForeName': 'Dragos', 'Initials': 'D', 'LastName': 'Chirnoaga', 'Affiliation': 'Department of Anaesthesiology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Van der Linden', 'Affiliation': 'Department of Anaesthesiology, Brugmann Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Barvais', 'Affiliation': 'Department of Anaesthesiology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Brenton', 'Initials': 'B', 'LastName': 'Alexander', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Duranteau', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Hôpitaux Universitaires Paris-Sud, Université Paris-Sud, Université Paris-Saclay, Hôpital De Bicêtre, Assistance Publique Hôpitaux de Paris, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Vincent', 'Affiliation': 'Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Cannesson', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rinehart', 'Affiliation': 'Department of Anesthesiology and Perioperative Care, University of California Irvine, Irvine, CA, USA.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.08.051']
2206,33041017,Early hospital discharge following non-operative management of blunt liver and splenic trauma: A pilot randomized controlled trial.,"BACKGROUND


Despite the acceptance of non-operative management (NOM), there is no consensus on the optimal length of hospital stay in patients with blunt liver and splenic injury (BLSI). Recent studies on pediatric patients have demonstrated the safety of early discharge following NOM for BLSI. We aimed at evaluating the feasibility and safety of early discharge in adult patients with BLSI following NOM in a randomized controlled trial.
MATERIALS AND METHODS


After initial assessment and management, patients aged 18-60 years with BLSI planned for NOM were randomized into 2 groups: Group A (test group; discharge day 3), and Group B (control group; discharge day 5). Standard NOM protocol was followed. These patients were discharged on the proposed day if they met the pre-defined discharge criteria. All patients were followed at days 7, 15, and 30 of discharge.
RESULTS


Sixty patients were recruited, 30 randomized to each arm. Most patients were males and aged less than 30 years. Road traffic injury was the most common mode of injury. Both groups were comparable in demography and injury-related parameters. 27 patients (90%) from group A and 28 patients (93%) from group B were discharged on the proposed day. Three patients had unplanned hospital visits for reasons unrelated to BLSI. All patients were asymptomatic and had a normal examination during their scheduled follow-up visits.
CONCLUSION


Adult patients undergoing NOM for BLSI can be safely discharged after 48 h of in-hospital observation, provided other injuries precluding discharge do not exist.",2020,Both groups were comparable in demography and injury-related parameters.,"['Adult patients undergoing', 'patients aged 18-60 years with BLSI planned for NOM', 'Most patients were males and aged less than 30 years', 'blunt liver and splenic trauma', 'pediatric patients', 'adult patients with BLSI following NOM', 'patients with blunt liver and splenic injury (BLSI', 'Sixty patients', 'All patients were asymptomatic and had a normal examination during their scheduled follow-up visits']",['NOM for BLSI'],['unplanned hospital visits'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0160405', 'cui_str': 'Injury of spleen'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0160405', 'cui_str': 'Injury of spleen'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}]",60.0,0.241453,Both groups were comparable in demography and injury-related parameters.,"[{'ForeName': 'Vignesh', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Division of Trauma Surgery & Critical Care, Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi, India; Department of Trauma Surgery, Christian Medical College & Hospital, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Biplab', 'Initials': 'B', 'LastName': 'Mishra', 'Affiliation': 'Division of Trauma Surgery & Critical Care, Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi, India.'}, {'ForeName': 'Mohit Kumar', 'Initials': 'MK', 'LastName': 'Joshi', 'Affiliation': 'Division of Trauma Surgery & Critical Care, Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi, India. Electronic address: drmohitjoshi@gmail.com.'}, {'ForeName': 'Vijayan', 'Initials': 'V', 'LastName': 'Purushothaman', 'Affiliation': 'Division of Trauma Surgery & Critical Care, Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi, India.'}, {'ForeName': 'Harshit', 'Initials': 'H', 'LastName': 'Agarwal', 'Affiliation': 'Division of Trauma Surgery & Critical Care, Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi, India.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Anwer', 'Affiliation': 'Division of Trauma Surgery & Critical Care, Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi, India.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Sagar', 'Affiliation': 'Division of Trauma Surgery & Critical Care, Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi, India.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Division of Trauma Surgery & Critical Care, Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Division of Trauma Surgery & Critical Care, Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi, India.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Bagaria', 'Affiliation': 'Division of Trauma Surgery & Critical Care, Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi, India.'}, {'ForeName': 'Narendra', 'Initials': 'N', 'LastName': 'Choudhary', 'Affiliation': 'Division of Trauma Surgery & Critical Care, Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi, India.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Division of Trauma Surgery & Critical Care, Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi, India.'}, {'ForeName': 'Pratyusha', 'Initials': 'P', 'LastName': 'Priyadarshini', 'Affiliation': 'Division of Trauma Surgery & Critical Care, Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi, India.'}, {'ForeName': 'Kapil Dev', 'Initials': 'KD', 'LastName': 'Soni', 'Affiliation': 'Division of Trauma Surgery & Critical Care, Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi, India.'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Aggarwal', 'Affiliation': 'Division of Trauma Surgery & Critical Care, Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi, India.'}]",Injury,['10.1016/j.injury.2020.10.013']
2207,33041018,Cross-education effect of balance training program in patients with chronic ankle instability: A randomized controlled trial.,"Chronic ankle instability (CAI) is frequently developed due to failure of the functional rehabilitation after acute ankle sprain. So, there is a need for an alternative way by which we can begin neuro-muscular control retraining sooner.
PURPOSE


This study was conducted to examine the effect of 6-week Single-limb Balance Training Program of the non-affected side on the Overall Stability Index (OASI), Antero-Posterior Stability Index (APSI), and the Medio-Lateral Stability Index (MLSI) of the affected side in females with unilateral CAI.
METHODS


Thirty-two female patients with CAI with mean age 20.96 ± 1.69 years participated in this study. They were randomly assigned into three groups: experimental group A (Cross-Education) (n = 11) performed the exercises for the non-affected side, experimental group B (Traditional Training) (n = 11) performed the exercises for the affected side, and Control group C (n = 10) did not perform any exercises. The randomization was done using statistical random tables. Data were collected using the Biodex Balance system before and after training.
RESULTS


Two-way mixed design MANOVA revealed that there were significant improvements in the mean values of the OASI, APSI and MLSI after training (p < .05) in both the Cross-Education group (A) and Traditional Training group (B) with no significant difference in-between for the OASI, MLSI and APSI after training. There was no significant difference (p > .05) between the pre and post-training mean values of the OASI, MLSI and APSI in the Control group (C).
CONCLUSION


Single-limb balance training for the non-affected side is effective in improving the postural control of the affected side in patients with CAI.",2020,"CONCLUSION


Single-limb balance training for the non-affected side is effective in improving the postural control of the affected side in patients with CAI.","['patients with CAI', 'patients with chronic ankle instability', 'females with unilateral CAI', 'Chronic ankle instability (CAI', 'Thirty-two female patients with CAI with mean age 20.96\xa0±\xa01.69 years participated in this study']","['balance training program', 'Single-limb balance training', 'experimental group A (Cross-Education) (n\xa0=\xa011) performed the exercises for the non-affected side, experimental group B (Traditional Training) (n\xa0=\xa011) performed the exercises for the affected side, and Control group C (n\xa0=\xa010) did not perform any exercises', '6-week Single-limb Balance Training Program']","['OASI, MLSI and APSI', 'mean values of the OASI, APSI and MLSI', 'Overall Stability Index (OASI), Antero-Posterior Stability Index (APSI), and the Medio-Lateral Stability Index (MLSI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",32.0,0.0194337,"CONCLUSION


Single-limb balance training for the non-affected side is effective in improving the postural control of the affected side in patients with CAI.","[{'ForeName': 'Nadia Magdy', 'Initials': 'NM', 'LastName': 'Elsotohy', 'Affiliation': 'Demonstrator of Biomechanics, Department of Biomechanics, Faculty of Physical Therapy, Cairo University, 7 Ahmed Ezzayyat street, Bein Essarayat, Giza, Egypt, 0236717691.'}, {'ForeName': 'Yassmin Essam', 'Initials': 'YE', 'LastName': 'Salim', 'Affiliation': 'Lecturer of Biomechanics, Department of Biomechanics, Faculty of Physical Therapy, Cairo University, 7 Ahmed Ezzayyat Street, Bein Essarayat, Giza, Egypt, 0236717691.'}, {'ForeName': 'Nagui Sobhi', 'Initials': 'NS', 'LastName': 'Nassif', 'Affiliation': 'Professor of Biomechanics, Departement of Biomechanics, Faculty of Physical Therapy, Cairo University.'}, {'ForeName': 'Abeer Farag', 'Initials': 'AF', 'LastName': 'Hanafy', 'Affiliation': 'Lecturer of Biomechanics, Department of Biomechanics, Faculty of Physical Therapy, Cairo University, 7 Ahmed Ezzayyat Street, Bein Essarayat, Giza, Egypt, 0236717691. Electronic address: abeerfarag22@gmail.com.'}]",Injury,['10.1016/j.injury.2020.09.065']
2208,33040481,Validation of brief symptom indexes among patients with recurrent or metastatic squamous cell carcinoma of the head and neck: A trial of the ECOG-ACRIN Cancer Research Group (E1302).,"BACKGROUND


Patients with advanced head and neck cancer have identified pain, fatigue, and difficulties swallowing, breathing, and communicating as high-priority disease-related symptoms. The Functional Assessment of Cancer Therapy-Head and Neck Symptom Index-10 (FHNSI-10) assesses these symptoms. We sought to validate the FHNSI-10, another brief symptom index (FHNSI-7), and individual symptom endpoints representing these high-rated priority disease symptoms among patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
METHODS


Patients (N = 239) were enrolled in a phase III randomized clinical trial (E1302) and completed the FHNSI-10 at multiple time points. We assessed the internal consistencies and test-retest reliabilities of the FHNSI-10 and FHNSI-7 scores, and the known-groups validity, predictive criterion validity, and responsiveness-to-change of the symptom indexes and individual symptom endpoint scores.
RESULTS


The FHNSI-10 and FHNSI-7 indexes showed satisfactory internal consistencies (Cronbach's alpha coefficient range 0.60-0.75) and acceptable test-retest reliabilities (intraclass correlation coefficients = 0.75 and 0.74, respectively). The FHNSI-10, FHNSI-7, and the pain, fatigue, swallowing, and breathing symptom scores showed evidence of known-groups validity by performance status at baseline. The FHNSI-10, FHNSI-7, and the pain, fatigue, and breathing symptom scores at baseline showed evidence of predictive criterion validity for overall survival, but not time-to-progression (TTP). Changes in the symptom indexes and individual symptom scores were not associated with changes in performance status over 4 weeks, though most patients had stable performance status.
CONCLUSIONS


There is initial evidence of validity for the FHNSI-10 and FHNSI-7 indexes and selected individual symptom endpoints as brief disease-related symptom assessments for patients with recurrent or metastatic SCCHN.",2020,"The FHNSI-10 and FHNSI-7 indexes showed satisfactory internal consistencies (Cronbach's alpha coefficient range 0.60-0.75) and acceptable test-retest reliabilities (intraclass correlation coefficients = 0.75 and 0.74, respectively).","['Patients with advanced head and neck cancer', 'patients with recurrent or metastatic squamous cell carcinoma of the head and neck', 'Patients (N\xa0=\xa0239', 'patients with recurrent or metastatic SCCHN', 'patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN']",[],"['time-to-progression (TTP', 'FHNSI-10, FHNSI-7, and the pain, fatigue, and breathing symptom scores', 'symptom indexes and individual symptom scores', 'FHNSI-10, FHNSI-7, and the pain, fatigue, swallowing, and breathing symptom scores', 'internal consistencies and test-retest reliabilities of the FHNSI-10 and FHNSI-7 scores, and the known-groups validity, predictive criterion validity, and responsiveness-to-change of the symptom indexes and individual symptom endpoint scores', 'acceptable test-retest reliabilities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424805', 'cui_str': 'Breath symptom'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0237828', 'cui_str': 'Test-Retest Reliability'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",239.0,0.0349812,"The FHNSI-10 and FHNSI-7 indexes showed satisfactory internal consistencies (Cronbach's alpha coefficient range 0.60-0.75) and acceptable test-retest reliabilities (intraclass correlation coefficients = 0.75 and 0.74, respectively).","[{'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Oswald', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Ju-Whei', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Department of Data Sciences, Dana-Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, MA, USA.'}, {'ForeName': 'Athanassios', 'Initials': 'A', 'LastName': 'Argiris', 'Affiliation': 'Department of Medical Oncology, Thomas Jefferson University Hospital, Philadelphia, PA, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Webster', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Arlene A', 'Initials': 'AA', 'LastName': 'Forastiere', 'Affiliation': 'Department of Oncology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}]",Cancer medicine,['10.1002/cam4.3506']
2209,33040491,Short-term changes in left and right systolic function following ferric carboxymaltose: a substudy of the Myocardial-IRON trial.,"AIMS


The mechanisms underlying the beneficial effect of ferric carboxymaltose (FCM) in patients with heart failure (HF) and iron deficiency (ID) have not been completely characterized. The Myocardial-IRON trial was a double-blind, randomized trial that evaluated myocardial iron repletion following FCM vs. placebo in 53 patients with HF and ID. In this post hoc analysis, we evaluated whether treatment with FCM was associated with cardiac magnetic resonance changes in left and right ventricular function (LVEF and RVEF, respectively) at different points of systolic dysfunction.
METHODS AND RESULTS


We included patients from the Myocardial-IRON trial with left and right ventricular systolic dysfunction (LVSD and RVSD, respectively) at enrolment. Linear mixed regression models were used to evaluate changes at 7 and 30 days on LVEF and RVEF at cardiac magnetic resonance. At enrolment, 27 (50.9%) and 38 (71.7%) patients had LVEF < 40% (LVSD 1  ) or <45% (LVSD 2  ), respectively, and 10 (18.9%) and 17 (32.1%) patients had RVEF < 45% (RVSD 1  ) or <51% in women and <52% in men (RVSD 2)  , respectively. Treatment with FCM was associated with a significant improvement in LVEF at 30 days (LVSD 1  : Δ2.3%, P < 0.001; LVSD 2  : Δ4.1, P = 0.014). FCM was also associated with a significant and early improvement in RVEF at 7 days (RVSD 1  : Δ6.9%, P = 0.003; RVSD 2  : Δ3.2%, P = 0.003) that persisted at 30 days (RVSD 1  : Δ8.1%, P < 0.001; RVSD 2  : Δ4.7%, P < 0.001).
CONCLUSIONS


In patients with HF and systolic dysfunction with ID, FCM was associated with short-term improvement in LVEF and, especially, in RVEF.",2020,"Treatment with FCM was associated with a significant improvement in LVEF at 30 days (LVSD 1  : Δ2.3%, P ","['patients from the Myocardial-IRON trial with left and right ventricular systolic dysfunction (LVSD and RVSD, respectively) at enrolment', 'patients with heart failure (HF) and iron deficiency (ID', 'patients had RVEF', '53 patients with HF and ID']","['FCM vs. placebo', 'FCM', 'ferric carboxymaltose', 'ferric carboxymaltose (FCM']","['LVEF', 'left and right systolic function', 'RVEF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1562095', 'cui_str': 'Right ventricular systolic dysfunction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",53.0,0.362072,"Treatment with FCM was associated with a significant improvement in LVEF at 30 days (LVSD 1  : Δ2.3%, P ","[{'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Santas', 'Affiliation': 'Cardiology Department, Hospital Clínico Universitario de Valencia, Universidad de Valencia, INCLIVA, Valencia, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Miñana', 'Affiliation': 'Cardiology Department, Hospital Clínico Universitario de Valencia, Universidad de Valencia, INCLIVA, Valencia, Spain.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Cardells', 'Affiliation': 'Cardiology Department, Hospital de Manises, Valencia, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Palau', 'Affiliation': 'Cardiology Department, Hospital Clínico Universitario de Valencia, Universidad de Valencia, INCLIVA, Valencia, Spain.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Llàcer', 'Affiliation': 'Internal Medicine Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Fácila', 'Affiliation': 'Cardiology Department, Hospital General Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Almenar', 'Affiliation': 'Cardiology Department, Hospital Universitario La Fe de Valencia, Valencia, Spain.'}, {'ForeName': 'Maria P', 'Initials': 'MP', 'LastName': 'López-Lereu', 'Affiliation': 'Cardiovascular Imaging Unit, ERESA-Ascires Biomedical Group, Valencia, Spain.'}, {'ForeName': 'Jose V', 'Initials': 'JV', 'LastName': 'Monmeneu', 'Affiliation': 'Cardiovascular Imaging Unit, ERESA-Ascires Biomedical Group, Valencia, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Sanchis', 'Affiliation': 'Cardiology Department, Hospital Clínico Universitario de Valencia, Universidad de Valencia, INCLIVA, Valencia, Spain.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Maceira', 'Affiliation': 'Cardiovascular Imaging Unit, ERESA-Ascires Biomedical Group, Valencia, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Bayés-Genís', 'Affiliation': 'CIBER Cardiovascular, Madrid, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Núñez', 'Affiliation': 'Cardiology Department, Hospital Clínico Universitario de Valencia, Universidad de Valencia, INCLIVA, Valencia, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",ESC heart failure,['10.1002/ehf2.13053']
2210,33040510,[A comparative study of endoscopic assisted lateral neck dissection and open lateral neck dissection in the treatment of cervical lymph node metastasis of papillary thyroid carcinoma].,"Objective: A prospective randomized controlled study of patients with thyroid papillary carcinoma requiring lateral neck dissection was conducted to investigate the thoroughness, safety and cosmetic features of endoscope-assisted lateral neck dissection.  Method: Patients who underwent total thyroidectomy, bilateral central lymph node dissection and unilateral lateral neck dissection for papillary thyroid cancer were randomly divided into two groups: endoscopic assisted group and open group, 18 cases in each group. The clinical characteristics, operation conditions, postoperative complications and aesthetic satisfaction of the two groups were compared.  Result: There were no statistically significant differences between the endoscopic group and the open group in age, gender, tumor size, dissection side, operation time, postoperative hospital stay, number of lymph nodes to be dissected, number of metastatic lymph nodes, postoperative hoarseness, and hypoparathyroidism（ P >0.05）; No hematoma or lymphatic leakage occurred in the two groups after surgery, and no tumor recurrence or residual was found in the ultrasound review at 6 months after surgery. Serum Tg level in the endoscopic group was higher than that in the open group at 6 months after surgery, but the difference between the two groups was not statistically significant（ P >0.05）; The neck pain score at day 3 after operation, the neck numbness and discomfort score at month 1 after operation, and the aesthetic satisfaction score at 3 months after operation in the endoscope assisted group were better than that in the open group（ P <0.05）.  Conclusion: Endoscope-assisted lateral neck dissection is safe, feasible and with excellent cosmetic effect for the treatment of lymph node metastasis in the lateral cervical region of papillary thyroid carcinoma.",2020,"There were no statistically significant differences between the endoscopic group and the open group in age, gender, tumor size, dissection side, operation time, postoperative hospital stay, number of lymph nodes to be dissected, number of metastatic lymph nodes, postoperative hoarseness, and hypoparathyroidism（ P >0.05）; No hematoma or lymphatic leakage occurred in the two groups after surgery, and no tumor recurrence or residual was found in the ultrasound review at 6 months after surgery.","['for papillary thyroid cancer', 'cervical lymph node metastasis of papillary thyroid carcinoma', 'patients with thyroid papillary carcinoma requiring lateral neck dissection']","['total thyroidectomy, bilateral central lymph node dissection and unilateral lateral neck dissection', 'endoscope-assisted lateral neck dissection', 'endoscopic assisted group and open group', 'endoscopic assisted lateral neck dissection and open lateral neck dissection', 'Endoscope-assisted lateral neck dissection']","['hematoma or lymphatic leakage', 'Serum Tg level', 'tumor size, dissection side, operation time, postoperative hospital stay, number of lymph nodes to be dissected, number of metastatic lymph nodes, postoperative hoarseness, and hypoparathyroidism', 'neck pain score', 'postoperative complications and aesthetic satisfaction', 'neck numbness and discomfort score', 'aesthetic satisfaction score']","[{'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C0588054', 'cui_str': 'Cervical lymph node group'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}]","[{'cui': 'C0193788', 'cui_str': 'Total thyroidectomy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0020626', 'cui_str': 'Hypoparathyroidism'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3805284', 'cui_str': 'Neck numbness'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",,0.0255306,"There were no statistically significant differences between the endoscopic group and the open group in age, gender, tumor size, dissection side, operation time, postoperative hospital stay, number of lymph nodes to be dissected, number of metastatic lymph nodes, postoperative hoarseness, and hypoparathyroidism（ P >0.05）; No hematoma or lymphatic leakage occurred in the two groups after surgery, and no tumor recurrence or residual was found in the ultrasound review at 6 months after surgery.","[{'ForeName': 'Zhibin', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery，Tianjin First Central Hospital，Tianjin，300192，China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery，Tianjin First Central Hospital，Tianjin，300192，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.09.015']
2211,33040557,Effects of exogenous probiotics on the gut microbiota and clinical outcomes in critically ill patients: a randomized controlled trial.,"BACKGROUND


Gut microbiota play an important role in the inflammation. This study aimed to investigate whether exogenous probiotics could improve the intestinal barrier function effect via attenuating inflammation and immunomodulation to improve the clinical outcomes in critically ill patients.
METHODS


A single-blind, randomized controlled trial was performed in a respiratory intensive care unit (RICUs). Patients assigned to the intervention group received probiotics Clostridium butyricum until death or discharge. Stool and blood samples were collected on the 1st day and 15th day of administration. Primary clinical outcomes and clinical manifestations were recorded during the follow-up period.
RESULTS


There were 61 patients in this study, with 28 patients receiving probiotics. There were no differences in the mortality and hospital stay between intervention group and control group. In addition, the duration of fever (% of hospital stays) was significantly shorter in the intervention group as compared to control group (4.85% vs. 12.94%, P=0.00). The incidence of constipation significantly reduced in the intervention group (17.86% vs. 42.42%, P=0.04). The overall ratio of gastrointestinal adverse effects was comparable between them. Bactericides significantly decreased after probiotic intervention (Δm=-0.69, P=0.048), while Escherichia coli and Enterococcus tended to decrease in the intervention group (Δm=-0.65, P=0.08; Δm=-0.52, P=0.22) on the day 15. No fluctuation was observed in the Bifidobacterium and Lactobacillus after probiotic intervention.
CONCLUSIONS


Our study fails to show the beneficial effects of probiotics on the primary clinical outcomes in critically ill patients. The intestinal barrier is damaged, and probiotics may reduce the burden of Gm-bacteria from the gut.",2020,"Bactericides significantly decreased after probiotic intervention (Δm=-0.69, P=0.048), while Escherichia coli and Enterococcus tended to decrease in the intervention group (Δm=-0.65, P=0.08; Δm=-0.52, P=0.22) on the day 15.","['61 patients in this study, with 28 patients receiving probiotics', 'critically ill patients']","['exogenous probiotics', 'probiotics', 'probiotics Clostridium butyricum until death or discharge']","['overall ratio of gastrointestinal adverse effects', 'mortality and hospital stay', 'Stool and blood samples', 'duration of fever', 'Escherichia coli and Enterococcus', 'Bactericides', 'clinical manifestations', 'gut microbiota and clinical outcomes', 'incidence of constipation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0315063', 'cui_str': 'Clostridium butyricum'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0085494', 'cui_str': 'Genus Enterococcus'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",61.0,0.116413,"Bactericides significantly decreased after probiotic intervention (Δm=-0.69, P=0.048), while Escherichia coli and Enterococcus tended to decrease in the intervention group (Δm=-0.65, P=0.08; Δm=-0.52, P=0.22) on the day 15.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology Medicine, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Ke', 'Affiliation': 'Clinic and Research Center of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Kai-Xiong', 'Initials': 'KX', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Jie-Ming', 'Initials': 'JM', 'LastName': 'Qu', 'Affiliation': 'Department of Pulmonary Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China. jmqu0906@163.com.'}]",Annals of palliative medicine,['10.21037/apm-20-202']
2212,33040584,Association of Disease Progression With Cardiovascular and Limb Outcomes in Patients With Peripheral Artery Disease: Insights From the EUCLID Trial.,"BACKGROUND


Patients with peripheral artery disease have a high risk of future cardiovascular disease events and mortality. Little is known about the changes in symptom classification over time in patients with peripheral artery disease and the association of changes in symptom classification with subsequent cardiovascular disease events.
METHODS


In this analysis of the EUCLID trial (Examining Use of Ticagrelor in Peripheral Artery Disease), we examined the changes in Rutherford classification (RC) of patients over 12 months. We examined the baseline characteristics of patients by change in symptom classification at 12 months (improved=decreased RC, no change, or worsened=increased RC), and the association between changes in symptom classification (RC) at 12 months and subsequent cardiovascular disease events.
RESULTS


Among 12 759 patients, 3240 (25%) were classified as improved by RC at 12 months, 8132 (64%) as no change, and 1387 (11%) as worsened. At 12 months, many patients who were asymptomatic or had mild/moderate claudication at enrollment had no change in symptom classification over 12 months (73.7% and 70.9%). Patients who worsened over 12 months were more likely to have comorbidities (diabetes mellitus and prior myocardial infarction) and more events (myocardial infarction, amputation, and major bleeding) by 12 months postrandomization, all  P <0.001. Worsened symptom classification over 12 months was associated with increased risk of all-cause death (adjusted hazard ratio, 1.29 [95% CI, 1.03-1.62]), major amputation (adjusted hazard ratio, 4.12 [95% CI, 2.46-6.88]), and a composite of cardiovascular death, myocardial infarction, or stroke (adjusted hazard ratio, 1.30 [95% CI, 1.05-1.62]), all  P <0.05 after 12 months postrandomization.
CONCLUSIONS


Patients with comorbidities and prior history of cardiovascular disease events at baseline and within the first 12 months of the trial were more likely to have worsened symptom classification at 12 months. Worsening symptom classification over 12 months was associated subsequently with an increased risk of all-cause death, amputation, and a composite of cardiovascular death, myocardial infarction, or stroke.",2020,"Worsened symptom classification over 12 months was associated with increased risk of all-cause death (adjusted hazard ratio, 1.29 [95% CI, 1.03-1.62]), major amputation (adjusted hazard ratio, 4.12 [95% CI, 2.46-6.88]), and a composite of cardiovascular death, myocardial infarction, or stroke (adjusted hazard ratio, 1.30 [95% CI, 1.05-1.62]), all  P <0.05 after 12 months postrandomization.
","['Patients With Peripheral Artery Disease', 'patients with peripheral artery disease', 'Patients with peripheral artery disease']",['Ticagrelor'],"['Worsening symptom classification', 'mild/moderate claudication', 'major amputation', 'RC', 'composite of cardiovascular death, myocardial infarction, or stroke', 'risk of all-cause death', 'risk of all-cause death, amputation, and a composite of cardiovascular death, myocardial infarction, or stroke', 'comorbidities (diabetes mellitus and prior myocardial infarction) and more events (myocardial infarction, amputation, and major bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",12759.0,0.0906782,"Worsened symptom classification over 12 months was associated with increased risk of all-cause death (adjusted hazard ratio, 1.29 [95% CI, 1.03-1.62]), major amputation (adjusted hazard ratio, 4.12 [95% CI, 2.46-6.88]), and a composite of cardiovascular death, myocardial infarction, or stroke (adjusted hazard ratio, 1.30 [95% CI, 1.05-1.62]), all  P <0.05 after 12 months postrandomization.
","[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Rymer', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC (J.A.R., D.I.N., W.S.J., M.R.P.).'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Mulder', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (H.M., F.R.).'}, {'ForeName': 'Dennis I', 'Initials': 'DI', 'LastName': 'Narcisse', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC (J.A.R., D.I.N., W.S.J., M.R.P.).'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (H.M., F.R.).'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Hiatt', 'Affiliation': 'University of Colorado School of Medicine, CPC Clinical Research, Aurora (W.R.H.).'}, {'ForeName': 'F Gerry', 'Initials': 'FG', 'LastName': 'Fowkes', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, United Kingdom (F.G.F).'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Baumgartner', 'Affiliation': 'Swiss Cardiovascular Center, Bern, Switzerland (I.B.).'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': 'Division of Cardiology, NYU Langone Health, New York, NY (J.S.B.).'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Katona', 'Affiliation': 'AstraZeneca, Gaithersburg, MD (B.G.K.).'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University School of Medicine, CA (K.M.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Norgren', 'Affiliation': 'Faculty of Medicine and Health, Orebro University, Sweden (L.N.).'}, {'ForeName': 'Juuso I', 'Initials': 'JI', 'LastName': 'Blomster', 'Affiliation': 'University of Turku, Finland (J.I.B.).'}, {'ForeName': 'W Schuyler', 'Initials': 'WS', 'LastName': 'Jones', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC (J.A.R., D.I.N., W.S.J., M.R.P.).'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC (J.A.R., D.I.N., W.S.J., M.R.P.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009326']
2213,33040586,"Effects of forehead cooling and supportive care on menopause-related sleep difficulties, hot flashes and menopausal symptoms: a pilot study.","OBJECTIVE/BACKGROUND


This pilot study explored the efficacy of a novel forehead cooling device for perceived sleep difficulties and hot flashes in menopausal-age women.
PARTICIPANTS


20 women (55.1 ± 4.2 years; 19 post-menopausal) with insomnia symptoms and self-reported two or more hot flashes per day.
METHODS


Participants completed daily assessments of sleep and hot flashes (via diaries) across 1 baseline week and 4 weeks of open-label, in-home, nightly treatment with a forehead cooling device (15-18°C) along with sleep hygiene instructions. They also completed ratings of insomnia and menopausal symptoms using standardized questionnaires.
RESULTS


Women reported reductions in sleep onset latency (SOL), wakefulness after sleep onset (WASO), and nocturnal hot flash severity during the first week of treatment (SOL: 25.7 ± 18.4 min; WASO: 36.3 ± 27.3 min; hot flash severity: 3.0 ± 2.8) compared with baseline (SOL: 38 ± 26.3 min; WASO: 52.2 ± 35.6 min; hot flash severity: 6.8 ± 3.7), with further improvements after 2-4 weeks of use ( p  < .001). There were also clinically meaningful reductions in insomnia severity and hot flash-related daily interference and lower psychological and physical symptom scores on the Greene climacteric scale after treatment (all p's<0.001).
CONCLUSIONS


This exploratory, naturalistic, pilot study shows that nightly use of a forehead cooling device produces improvements in self-reported sleep and reductions in insomnia, hot flash, and other menopausal, symptoms. Controlled studies are warranted to determine the role of this therapy in the management of sleep difficulties and menopausal symptoms in women. Further mechanistic studies are needed to understand the physiological impact of forehead cooling on sleep and menopausal symptoms.",2020,"There were also clinically meaningful reductions in insomnia severity and hot flash-related daily interference and lower psychological and physical symptom scores on the Greene climacteric scale after treatment (all p's<0.001).
","['20 women (55.1\xa0±\xa04.2\xa0years; 19 post-menopausal) with insomnia symptoms and self-reported two or more hot flashes per day', 'women', 'menopausal-age women']","['open-label, in-home, nightly treatment with a forehead cooling device', 'forehead cooling and supportive care', 'forehead cooling device', 'novel forehead cooling device']","['self-reported sleep and reductions in insomnia, hot flash, and other menopausal, symptoms', 'sleep and hot flashes (via diaries', 'Greene climacteric scale', 'menopause-related sleep difficulties, hot flashes and menopausal symptoms', 'sleep onset latency (SOL), wakefulness after sleep onset (WASO), and nocturnal hot flash severity', 'insomnia severity and hot flash-related daily interference and lower psychological and physical symptom scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0008943', 'cui_str': 'Change of Life'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.138142,"There were also clinically meaningful reductions in insomnia severity and hot flash-related daily interference and lower psychological and physical symptom scores on the Greene climacteric scale after treatment (all p's<0.001).
","[{'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Baker', 'Affiliation': 'Center for Health Sciences, SRI International , Menlo Park, California, USA.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'de Zambotti', 'Affiliation': 'Center for Health Sciences, SRI International , Menlo Park, California, USA.'}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Chiappetta', 'Affiliation': 'DataDIVA, LLC , Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Nofzinger', 'Affiliation': 'Ebb Therapeutics , Pittsburgh, Pennsylvania, USA.'}]",Behavioral sleep medicine,['10.1080/15402002.2020.1826484']
2214,33040590,A smartphone application to facilitate adherence to home-based exercise after flexor tendon repair: A randomised controlled trial.,"OBJECTIVE


Evaluate the effect of a smartphone application on exercise adherence, range of motion and self-efficacy compared to standard rehabilitation after repair of the flexor digitorum profundus tendon.
DESIGN


Prospective multi-centre randomised controlled trial.
SETTING


Four hand surgery departments in Sweden.
SUBJECTS


A total of 101 patients (35 women) (mean age 37.5 ± 12.8) were randomised to control ( n  = 49) or intervention group ( n  = 52).
INTERVENTION


A smartphone application to facilitate rehabilitation.
MAIN OUTCOME MEASURES


Adherence assessed with the Sport Injury Rehabilitation Adherence Scale at two and six weeks (primary outcome). Secondary outcomes were self-reported adherence in three domains assessed at two and six weeks, self-efficacy assessed with Athlete Injury Self-Efficacy Questionnaire at baseline, two and six weeks. Range of motion and perceived satisfaction with rehabilitation and information were assessed at 12 weeks.
RESULTS


Twenty-five patients were lost to follow-up. There was no significant between group difference in Sport Injury Rehabilitation Adherence Scale at two or six weeks, mean scores (confidence interval, CI 95%) 12.5 (CI 11.8-13.3), 11.8 (CI 11.0-12.8) for the intervention group, and 13.3 (CI 12.6-14.0), 12.8 (CI 12.0-13.7) for the control group. Self-reported adherence for exercise frequency at six weeks was significantly better for the intervention group, 93.2 (CI 86.9-99.5) compared to the controls 82.9 (CI 76.9-88.8) ( P  = 0.02). There were no differences in range of motion, self-efficacy or satisfaction.
CONCLUSION


The smartphone application used in this study did not improve adherence, self-efficacy or range of motion compared to standard rehabilitation for flexor tendon injuries. Further research regarding smartphone applications is needed.
LEVEL OF EVIDENCE


I. Randomised controlled trial.",2020,"The smartphone application used in this study did not improve adherence, self-efficacy or range of motion compared to standard rehabilitation for flexor tendon injuries.","['Four hand surgery departments in Sweden', 'mean age 37.5\u2009±\u200912.8', 'flexor tendon repair', 'A total of 101 patients (35 women']","['smartphone application', 'standard rehabilitation']","['range of motion, self-efficacy or satisfaction', 'Adherence assessed with the Sport Injury Rehabilitation Adherence Scale', 'Self-reported adherence for exercise frequency', 'Sport Injury Rehabilitation Adherence Scale', 'self-reported adherence in three domains assessed at two and six weeks, self-efficacy assessed with Athlete Injury Self-Efficacy Questionnaire', 'exercise adherence, range of motion and self-efficacy', 'adherence, self-efficacy or range of motion']","[{'cui': 'C0587521', 'cui_str': 'Hand surgery department'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517742', 'cui_str': '37.5'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C0224848', 'cui_str': 'Structure of flexor tendon'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0004161', 'cui_str': 'Sports injury'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0556455', 'cui_str': 'Frequency of exercise'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",101.0,0.174561,"The smartphone application used in this study did not improve adherence, self-efficacy or range of motion compared to standard rehabilitation for flexor tendon injuries.","[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Svingen', 'Affiliation': 'Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Rosengren', 'Affiliation': 'Department of Hand Surgery, Södersjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Turesson', 'Affiliation': 'Department of Hand Surgery, Plastic Surgery and Burns, and Department of Biomedical and Clinical Sciences Experimental, Linköping University, Linkoping, Sweden.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Arner', 'Affiliation': 'Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.'}]",Clinical rehabilitation,['10.1177/0269215520962287']
2215,33040598,The effect of an integrated multidisciplinary rehabilitation programme for patients with chronic low back pain: Long-term follow up of a randomised controlled trial.,"OBJECTIVE


To compare the long-term effectiveness of an integrated rehabilitation programme with an existing rehabilitation programme, in terms of back-specific disability, in patients with chronic low back pain.
DESIGN


A single-centre, pragmatic, two-arm parallel, randomised controlled trial.
SETTING


A rheumatology rehabilitation centre in Denmark.
SUBJECTS


A total of 165 adults (aged ⩾ 18 years) with chronic low back pain.
INTERVENTIONS


An integrated programme (a pre-admission day, two weeks at home, two weeks inpatient followed by home-based activities, plus two 2-day inpatient booster sessions, and six-month follow-up visit) was compared with an existing programme (four-week inpatient, and six-month follow-up visit).
MAIN MEASURE


The primary outcome was disability measured using the Oswestry Disability Index after one year. Secondary outcomes included pain intensity (Numerical Rating Scale), pain self-efficacy (Pain Self-Efficacy Questionnaire), health-related quality of life (EuroQol-5 Domain 5-level (EQ-5D)), and depression (Major Depression Inventory). Analysis was by intention-to-treat, using linear mixed models.
RESULTS


303 patients were assessed for eligibility of whom 165 patients (mean age 50 years (SD 13) with a mean Oswestry Disability Index score of 42 (SD 11)) were randomly allocated (1:1 ratio) to the integrated programme ( n  = 82) or the existing programme ( n  = 83). The mean difference (integrated programme minus existing programme) in disability was -0.53 (95% CI -4.08 to 3.02);  p  = 0.770). No statistically significant differences were found in the secondary outcomes.
CONCLUSION


The integrated programme was not more effective in reducing long-term disability in patients with chronic low back pain than the existing programme.",2020,The integrated programme was not more effective in reducing long-term disability in patients with chronic low back pain than the existing programme.,"['A rheumatology rehabilitation centre in Denmark', '303 patients were assessed for eligibility of whom 165 patients (mean age 50\u2009years (SD 13) with a mean Oswestry Disability Index score of 42 (SD 11', 'patients with chronic low back pain', '165 adults (aged ⩾ 18\u2009years) with chronic low back pain']","['integrated programme ( n \u2009=\u200982) or the existing programme', 'integrated multidisciplinary rehabilitation programme', 'integrated rehabilitation programme with an existing rehabilitation programme']","['pain intensity (Numerical Rating Scale), pain self-efficacy (Pain Self-Efficacy Questionnaire), health-related quality of life (EuroQol-5 Domain 5-level (EQ-5D)), and depression (Major Depression Inventory', 'long-term disability', 'disability measured using the Oswestry Disability Index']","[{'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C4075347', 'cui_str': 'Pain Self-efficacy Questionnaire'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",303.0,0.161787,The integrated programme was not more effective in reducing long-term disability in patients with chronic low back pain than the existing programme.,"[{'ForeName': 'Anne Mette', 'Initials': 'AM', 'LastName': 'Schmidt', 'Affiliation': 'Department of Public Health, Centre for Rehabilitation Research, Aarhus University, Aarhus C, Denmark.'}, {'ForeName': 'Trine Bay', 'Initials': 'TB', 'LastName': 'Laurberg', 'Affiliation': 'Sano, Højbjerg, Denmark.'}, {'ForeName': 'Line Thorndal', 'Initials': 'LT', 'LastName': 'Moll', 'Affiliation': 'Spine Centre, Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Schiøttz-Christensen', 'Affiliation': 'Spine Centre of Southern Denmark, University Hospital Lillebælt, Middelfart, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Maribo', 'Affiliation': 'Department of Public Health, Centre for Rehabilitation Research, Aarhus University, Aarhus C, Denmark.'}]",Clinical rehabilitation,['10.1177/0269215520963856']
2216,33040675,Acceptability of pharmacist-led interventions to resolve drug-related problems in patients with chronic myeloid leukaemia.,"PURPOSE


Chronic myeloid leukaemia (CML) patients on long-term tyrosine kinase inhibitor (TKI) therapy are susceptible to drug-related problems (DRPs). This study aimed to evaluate the acceptability and outcomes of pharmacist-led interventions on DRPs encountered by CML patients.
METHODS


This study included participants from the intervention arm of a randomised controlled trial which was conducted to evaluate the effects of pharmacist-led interventions on CML patients treated with TKIs. Participants were recruited and followed up in the haematology clinics of two hospitals in Malaysia from March 2017 to January 2019. A pharmacist identified DRPs and helped to resolve them. Patients were followed-up for six months, and their DRPs were assessed based on the Pharmaceutical Care Network Europe Classification for DRP v7.0. The identified DRPs, the pharmacist's interventions, and the acceptance and outcomes of the interventions were recorded. A Poisson multivariable regression model was used to analyse factors associated with the number of identified DRPs per participant.
RESULTS


A total of 198 DRPs were identified from 65 CML patients. The median number of DRPs per participants was 3 (interquartile range: 2, 4). Most participants (97%) had at least one DRP, which included adverse drug events (45.5%), treatment ineffectiveness (31.5%) and patients' treatment concerns or dissatisfaction (23%). The 228 causes of DRPs identified comprised the following: lack of disease or treatment information, or outcome monitoring (47.8%), inappropriate drug use processes (23.2%), inappropriate patient behaviour (19.9%), suboptimal drug selection (6.1%), suboptimal dose selection (2.6%) and logistic issues in dispensing (0.4%). The number of concomitant medications was significantly associated with the number of DRPs (adjusted Odds Ratio: 1.100; 95% CI: 1.005, 1.205; p = 0.040). Overall, 233 interventions were made. These included providing patient education on disease states or TKI-related side effects (75.1%) and recommending appropriate instructions for taking medications (7.7%). Of the 233 interventions, 94.4% were accepted and 83.7% were implemented by the prescriber or patient. A total of 154 DRPs (77.3%) were resolved.
CONCLUSIONS


The pharmacist-led interventions among CML patients managed to identify various DRPs, were well accepted by both TKI prescribers and patients, and had a high success rate of resolving the DRPs.",2020,"The pharmacist-led interventions among CML patients managed to identify various DRPs, were well accepted by both TKI prescribers and patients, and had a high success rate of resolving the DRPs.","['Participants were recruited and followed up in the haematology clinics of two hospitals in Malaysia from March 2017 to January 2019', 'DRPs encountered by CML patients', 'patients with chronic myeloid leukaemia', 'Chronic myeloid leukaemia (CML) patients on long-term', 'A total of 198 DRPs were identified from 65 CML patients']","['pharmacist-led interventions', 'CML patients treated with TKIs', 'tyrosine kinase inhibitor (TKI) therapy']","['inappropriate patient behaviour', 'suboptimal drug selection', 'number of concomitant medications', 'inappropriate drug use processes', 'number of DRPs', 'median number of DRPs', 'adverse drug events']","[{'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3839291', 'cui_str': 'Hematology clinic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}]",198.0,0.101569,"The pharmacist-led interventions among CML patients managed to identify various DRPs, were well accepted by both TKI prescribers and patients, and had a high success rate of resolving the DRPs.","[{'ForeName': 'Bee Kim', 'Initials': 'BK', 'LastName': 'Tan', 'Affiliation': ""School of Pharmacy, Faculty of Health and Medical Sciences, Taylor's University, Subang Jaya, Malaysia.""}, {'ForeName': 'Siew Siang', 'Initials': 'SS', 'LastName': 'Chua', 'Affiliation': ""School of Pharmacy, Faculty of Health and Medical Sciences, Taylor's University, Subang Jaya, Malaysia.""}, {'ForeName': 'Li-Chia', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'Centre for Pharmacoepidemiology and Drug Safety, Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Kian Meng', 'Initials': 'KM', 'LastName': 'Chang', 'Affiliation': 'Department of Hematology, 26691Ministry of Health Malaysia, Ampang Hospital, Ampang Jaya, Malaysia.'}, {'ForeName': 'Sharmini', 'Initials': 'S', 'LastName': 'Balashanker', 'Affiliation': 'School of Pharmacy, University of Nottingham Malaysia Campus, Semenyih, Malaysia.'}, {'ForeName': 'Ping Chong', 'Initials': 'PC', 'LastName': 'Bee', 'Affiliation': 'Department of Medicine, Faculty of Medicine, 37447University of Malaya, Kuala Lumpur, Malaysia.'}]",Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners,['10.1177/1078155220964539']
2217,33040678,Mental Imagery as a Rehabilitative Therapy for Neuropathic Pain in People With Spinal Cord Injury: A Randomized Controlled Trial.,"BACKGROUND


Pain of neuropathic origin in spinal cord injury (SCI) is unbearable and challenging to treat. Research studies conducted in the past have shown that mental imagery (MI) techniques have a significant impact on the reduction of symptoms of central neuropathic pain in people with SCI.
OBJECTIVES


The objective of this study was to evaluate the effect of MI training on pain intensity, neuropathic pain symptoms, and interference of pain with function in SCI.
METHODS


A total of 42 SCI participants with central neuropathic pain (duration 6-12 months) were recruited and randomly allocated to MI or control groups. A MI training protocol was administered to MI group and for 30 min/d for 5 days. Outcome measures were assessed at baseline and at the end of 4 weeks.
RESULTS


There was significant reduction in differences of mean [95% CI] scores of numeric rating scale (-2.1 [CI -2.78 to -1.41];  P  < .001) between groups. Mean [95% CI] total scores of Neuropathic Pain Symptom Inventory declined in MI group as compared with control group (-4.52 [CI -5.86 to -3.18];  P  < .001). Similarly, Brief Pain Inventory interference scale total dropped significantly ( P  < .001) in MI group. Majority of participants in the MI group (55%) reported improvement in scores of Patients' Global Impression of Change scale as compared with control group where most of the participants (52%) reported no change.
CONCLUSIONS


This study shows the effectiveness of the MI protocol developed as a rehabilitative approach in improving central neuropathic pain in SCI.  Trial Registration . Clinical Trials Registry-India under Indian Council of Medical Research; CTRI/2018/07/014884. Registered July 16, 2018.",2020,"Similarly, Brief Pain Inventory interference scale total dropped significantly ( P  < .001) in MI group.","['People With Spinal Cord Injury', 'A total of 42 SCI participants with central neuropathic pain (duration 6-12 months', 'spinal cord injury (SCI', 'people with SCI']","['MI training', 'MI protocol', 'Mental Imagery as a Rehabilitative Therapy']","['central neuropathic pain', 'Neuropathic Pain Symptom Inventory', 'pain intensity, neuropathic pain symptoms, and interference of pain with function', ""scores of Patients' Global Impression of Change scale"", 'Brief Pain Inventory interference scale total', 'numeric rating scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4087506', 'cui_str': 'Central neuropathic pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4087506', 'cui_str': 'Central neuropathic pain'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",42.0,0.34303,"Similarly, Brief Pain Inventory interference scale total dropped significantly ( P  < .001) in MI group.","[{'ForeName': 'Jaskirat', 'Initials': 'J', 'LastName': 'Kaur', 'Affiliation': 'Amity University, Noida, Uttar Pradesh, India.'}, {'ForeName': 'Shampa', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Indian Council of Medical Research-National Institute of Nutrition, Hyderabad, Telangana, India.'}, {'ForeName': 'Asish Kumar', 'Initials': 'AK', 'LastName': 'Sahani', 'Affiliation': 'Indian Spinal Injuries Centre, New Delhi, India.'}, {'ForeName': 'Jitendra Kumar', 'Initials': 'JK', 'LastName': 'Sinha', 'Affiliation': 'Amity University, Noida, Uttar Pradesh, India.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320962498']
2218,33040736,Optimizing smoke alarm signals: Testing the effectiveness of children's smoke alarms for sleeping adults.,"BACKGROUND


Being asleep is an important risk factor for death during a residential fire; however, the high-frequency tone smoke alarms in many homes will not adequately awaken children who are old enough to self-rescue. In a series of previous studies, we identified smoke alarm signals that effectively awaken children 5-12 years old and prompt their escape. Because it is impractical to have separate alarms for children and adults in a household, the purpose of this study is to test whether alarms that are effective in awakening children and prompting their escape are also effective among adults.
METHODS


Using a randomized, non-blinded, repeated measures design, 150 adults 20-49 years old were exposed during stage 4 sleep to four different smoke alarms. Statistical tests included the Kaplan-Meier estimator, generalized Wilcoxon test, and hazard ratios with Wald's 95% confidence intervals.
RESULTS


The median age of study subjects was 30.0 years and 67.3% were female. Almost all (n = 149) subjects awakened and performed the escape procedure to all four alarms; one individual did not awaken or escape to the high-frequency tone alarm. The median time-to-awaken was 2.0 s for the high-frequency tone alarm and 1.0 s for the other three alarms. The median time-to-escape for the high-frequency tone alarm was 12.0 s, compared with 10.0 s for the low-frequency tone alarm and 9.0 s each for the female and male voice alarms. All pairwise comparisons between the high-frequency tone alarm and each of the other three alarms were statistically significant for the probability functions for time-to-awaken and time-to-escape. There were no significant differences in these outcome measures between the latter three alarms, except for female voice versus low-frequency tone alarms for time-to-escape.
CONCLUSIONS


All alarms performed well, demonstrating that smoke alarms developed for the unique developmental requirements of sleeping children are also effective among sleeping adults. Compared with a high-frequency tone alarm, use of these alarms may reduce residential fire-related injuries and deaths among children, while also successfully alerting adult members of the household.",2020,"There were no significant differences in these outcome measures between the latter three alarms, except for female voice versus low-frequency tone alarms for time-to-escape.
","['The median age of study subjects was 30.0\u2009years and 67.3% were female', '150 adults 20-49\u2009years old were exposed during stage 4 sleep to four different smoke alarms', ""children's smoke alarms for sleeping adults"", 'Optimizing smoke alarm signals']",[],"['Kaplan-Meier estimator, generalized Wilcoxon test, and hazard ratios', 'median time-to-awaken', 'median time-to-escape']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",[],"[{'cui': 'C0401805', 'cui_str': 'Estimator'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",150.0,0.033668,"There were no significant differences in these outcome measures between the latter three alarms, except for female voice versus low-frequency tone alarms for time-to-escape.
","[{'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Smith', 'Affiliation': ""Center for Injury Research and Policy, The Abigail Wexner Research Institute at Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH, 43205, USA. Gary.Smith@nationwidechildrens.org.""}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Kistamgari', 'Affiliation': ""Center for Injury Research and Policy, The Abigail Wexner Research Institute at Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH, 43205, USA.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Splaingard', 'Affiliation': 'Department of Pediatrics, The Ohio State University College of Medicine, Columbus, OH, USA.'}]",Injury epidemiology,['10.1186/s40621-020-00279-6']
2219,33040741,Use of simulations to evaluate the effectiveness of barrier precautions to prevent patient-to-patient transfer of healthcare-associated pathogens.,"BACKGROUND


There is controversy regarding whether the addition of cover gowns offers a substantial benefit over gloves alone in reducing personnel contamination and preventing pathogen transmission.
DESIGN


Simulated patient care interactions.
OBJECTIVE


To evaluate the efficacy of different types of barrier precautions and to identify routes of transmission.
METHODS


In randomly ordered sequence, 30 personnel each performed 3 standardized examinations of mannequins contaminated with pathogen surrogate markers (cauliflower mosaic virus DNA, bacteriophage MS2, nontoxigenic Clostridioides difficile spores, and fluorescent tracer) while wearing no barriers, gloves, or gloves plus gowns followed by examination of a noncontaminated mannequin. We compared the frequency and routes of transfer of the surrogate markers to the second mannequin or the environment.
RESULTS


For a composite of all surrogate markers, transfer by hands occurred at significantly lower rates in the gloves-alone group (OR, 0.02; P < .001) and the gloves-plus-gown group (OR, 0.06; P = .002). Transfer by stethoscope diaphragms was common in all groups and was reduced by wiping the stethoscope between simulations (OR, 0.06; P < .001). Compared to the no-barriers group, wearing a cover gown and gloves resulted in reduced contamination of clothing (OR, 0.15; P < .001), but wearing gloves alone did not.
CONCLUSIONS


Wearing gloves alone or gloves plus gowns reduces hand transfer of pathogens but may not address transfer by devices such as stethoscopes. Cover gowns reduce the risk of contaminating the clothing of personnel.",2020,"For a composite of all surrogate markers, transfer by hands occurred at significantly lower rates in the gloves-alone group (OR, 0.02; P < .001) and the gloves-plus-gown group (OR, 0.06; P = .002).",[],"['mannequins contaminated with pathogen surrogate markers (cauliflower mosaic virus DNA, bacteriophage MS2, nontoxigenic Clostridioides difficile spores, and fluorescent tracer) while wearing no barriers, gloves, or gloves plus gowns followed by examination of a noncontaminated mannequin']",['reduced contamination of clothing'],[],"[{'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0086589', 'cui_str': 'Marker, Surrogate'}, {'cui': 'C1456463', 'cui_str': 'Cauliflower mosaic virus'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0206390', 'cui_str': 'Enterobacteria phage MS2'}, {'cui': 'C0079134', 'cui_str': 'Clostridium difficile (bacteria)'}, {'cui': 'C0038027', 'cui_str': 'Spores'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0181064', 'cui_str': 'Gown'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0009072', 'cui_str': 'Garments'}]",,0.0713151,"For a composite of all surrogate markers, transfer by hands occurred at significantly lower rates in the gloves-alone group (OR, 0.02; P < .001) and the gloves-plus-gown group (OR, 0.06; P = .002).","[{'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Alhmidi', 'Affiliation': 'Research Service, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Li', 'Affiliation': 'Research Service, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Cadnum', 'Affiliation': 'Research Service, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Muhammed F', 'Initials': 'MF', 'LastName': 'Haq', 'Affiliation': 'Research Service, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Natalia C', 'Initials': 'NC', 'LastName': 'Pinto-Herrera', 'Affiliation': 'Research Service, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Brigid M', 'Initials': 'BM', 'LastName': 'Wilson', 'Affiliation': 'Geriatric Research, Education and Clinical Center, Louis Stokes Cleveland VA Medical Center, Cleveland, OH.'}, {'ForeName': 'Curtis J', 'Initials': 'CJ', 'LastName': 'Donskey', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, Ohio.'}]",Infection control and hospital epidemiology,['10.1017/ice.2020.1215']
2220,33040755,Alcohol-impregnated caps and ambulatory central-line-associated bloodstream infections (CLABSIs): A randomized clinical trial.,"OBJECTIVE


To evaluate the effect of 70% isopropyl alcohol-impregnated central venous catheter caps on ambulatory central-line-associated bloodstream infections (CLABSIs) in pediatric hematology-oncology patients.
DESIGN


This study was a 24-month, cluster-randomized, 2 period, crossover clinical trial.
SETTING


The study was conducted in 15 pediatric healthcare institutions, including 16 pediatric hematology-oncology clinics.
PARTICIPANTS


All patients with an external central line followed at 1 of the 16 hematology-oncology clinics.
INTERVENTION


Usual ambulatory central-line care per each institution using 70% isopropyl alcohol-impregnated caps at home compared to usual ambulatory central-line care in each institution without using 70% isopropyl alcohol-impregnated caps.
RESULTS


Of the 16 participating clinics, 15 clinics completed both assignment periods. As assigned, there was no reduction in CLABSI incidence in clinics using 70% isopropyl alcohol-impregnated caps (1.23 per 1,000 days) compared with standard practices (1.38 per 1,000 days; adjusted incidence rate ratio [aIRR], 0.83; 95% CI, 0.63-1.11). In the per-protocol population, there was a reduction in positive blood culture incidence in clinics using 70% isopropyl alcohol-impregnated caps (1.51 per 1,000 days) compared with standard practices (1.88 per 1,000 days; aIRR, 0.72; 95% CI, 0.52-0.99). No adverse events were reported.
CONCLUSIONS


Isopropyl alcohol-impregnated central-line caps did not lead to a statistically significant reduction in CLABSI rates in ambulatory hematology-oncology patients. In the per-protocol analysis, there was a statistically significant decrease in positive blood cultures. Larger trials are needed to elucidate the impact of 70% isopropyl alcohol-impregnated caps in the ambulatory setting.
REGISTRATION


ClinicalTrials.gov; NCT02351258.",2020,"CONCLUSIONS


Isopropyl alcohol-impregnated central-line caps did not lead to a statistically significant reduction in CLABSI rates in ambulatory hematology-oncology patients.","['All patients with an external central line followed at 1 of the 16 hematology-oncology clinics', '16 participating clinics', 'ambulatory hematology-oncology patients', 'pediatric hematology-oncology patients', '15 pediatric healthcare institutions, including 16 pediatric hematology-oncology clinics']","['Usual ambulatory central-line care per each institution using 70% isopropyl alcohol-impregnated caps at home compared to usual ambulatory central-line care in each institution without using 70% isopropyl alcohol-impregnated caps', '70% isopropyl alcohol-impregnated central venous catheter caps', 'Alcohol-impregnated caps and ambulatory central-line-associated bloodstream infections (CLABSIs', 'Isopropyl alcohol-impregnated central-line caps', 'isopropyl alcohol-impregnated caps']","['CLABSI incidence', 'adverse events', 'positive blood cultures', 'CLABSI rates', 'positive blood culture incidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1518927', 'cui_str': 'Pediatric hematology oncology'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1279810', 'cui_str': 'Care of central line'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022237', 'cui_str': 'Isopropyl Alcohol'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C3161235', 'cui_str': 'CLABSI - central line associated bloodstream infection'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0740299', 'cui_str': 'Blood culture positive for microorganism'}]",15.0,0.0760498,"CONCLUSIONS


Isopropyl alcohol-impregnated central-line caps did not lead to a statistically significant reduction in CLABSI rates in ambulatory hematology-oncology patients.","[{'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Milstone', 'Affiliation': 'Department of Pediatrics, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Pediatrics, Division of Quality and Safety, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Gayane', 'Initials': 'G', 'LastName': 'Yenokyan', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Danielle W', 'Initials': 'DW', 'LastName': 'Koontz', 'Affiliation': 'Department of Pediatrics, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Marlene R', 'Initials': 'MR', 'LastName': 'Miller', 'Affiliation': 'Department of Pediatrics, Division of Quality and Safety, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Infection control and hospital epidemiology,['10.1017/ice.2020.467']
2221,33040772,Targeting the perinatal diet to modulate the gut microbiota increases dietary variety and prebiotic and probiotic food intakes: results from a randomised controlled trial.,"OBJECTIVE


To evaluate the hypothesis that a perinatal educational dietary intervention focused on 'eating for the gut microbiota' improves diet quality of pregnant women pre- and postnatally.
DESIGN


The Healthy Parents, Healthy Kids study is a prospectively registered randomised controlled trial designed to evaluate the efficacy of a dietary intervention in altering the maternal and infant gut microbiota and improving perinatal diet quality. Eligible pregnant women were randomised to receive dietary advice from their healthcare provider or to additionally receive a three session dietary intervention. Dietary data were collected at gestation weeks 26, 31, 36 and postnatal week 4. Outcome measures were diet quality, dietary variety, prebiotic and probiotic food intakes, energy, fibre, saturated fat and discretionary food intakes. Between-group differential changes from baseline before and after birth in these dietary measures were assessed using generalised estimating equations.
SETTING


Melbourne, Australia.
PARTICIPANTS


Healthy pregnant women from gestation week 26.
RESULTS


Forty-five women were randomised (twenty-two control, twenty-three intervention). Compared with the control group, the intervention group improved diet quality prior to birth (5·66 (95 % CI 1·65, 9·67), Cohen's d: 0·82 (se 0·33)). The intervention improved dietary variety (1·05 (95 % CI 0·17, 1·94), d: 0·66 (se 0·32)) and increased intakes of prebiotic (0·8 (95 % CI 0·27, 1·33), d: 0·91 (se 0·33)) and probiotic foods (1·05 (95 % CI 0·57, 1·53), d: 1·3(se 0·35)) over the whole study period compared with the control group.
CONCLUSION


A dietary intervention focused on 'eating for the gut microbiota' can improve aspects of perinatal diet quality during and after pregnancy.",2020,"The intervention improved dietary variety (1·05 (95 % CI 0·17, 1·94), d: 0·66 (se 0·32)) and increased intakes of prebiotic (0·8 (95 % CI 0·27, 1·33), d: 0·91 (se 0·33)) and probiotic foods (1·05 (95 % CI 0·57, 1·53), d: 1·3(se 0·35)) over the whole study period compared with the control group.
","['Healthy Parents, Healthy Kids study', 'Melbourne, Australia', 'Healthy pregnant women from gestation week 26', 'Eligible pregnant women', 'pregnant women pre- and postnatally', ""Cohen's d: 0·82"", 'Forty-five women']","['gut microbiota increases dietary variety and prebiotic and probiotic food intakes', 'dietary advice from their healthcare provider or to additionally receive a three session dietary intervention', 'dietary intervention', 'perinatal educational dietary intervention']","['diet quality, dietary variety, prebiotic and probiotic food intakes, energy, fibre, saturated fat and discretionary food intakes', 'intakes of prebiotic', 'dietary variety', 'diet quality', 'diet quality prior to birth', 'perinatal diet quality']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}]",45.0,0.0914365,"The intervention improved dietary variety (1·05 (95 % CI 0·17, 1·94), d: 0·66 (se 0·32)) and increased intakes of prebiotic (0·8 (95 % CI 0·27, 1·33), d: 0·91 (se 0·33)) and probiotic foods (1·05 (95 % CI 0·57, 1·53), d: 1·3(se 0·35)) over the whole study period compared with the control group.
","[{'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Dawson', 'Affiliation': 'iMPACT (the Institute for Mental and Physical Health and Clinical Translation), Food & Mood Centre, Deakin University, Health Education and Research Building (HERB), Level 3, PO Box 281, Geelong, VIC3220, Australia.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Faculty of Health, Biostatistics Unit, Deakin University, Geelong, Australia.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Craig', 'Affiliation': ""Murdoch Children's Research Institute, Royal Children's Hospital, Environmental & Genetic Epidemiology Research, Parkville, Australia.""}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'Centre for Research in Assessment and Digital Learning, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Clarke', 'Affiliation': 'Department of Psychiatry and Neurobehavioural Science, University College Cork, Cork, Ireland.'}, {'ForeName': 'Mimi Lk', 'Initials': 'ML', 'LastName': 'Tang', 'Affiliation': ""Murdoch Children's Research Institute, Royal Children's Hospital, Allergy Immunology Research, Parkville, Australia.""}, {'ForeName': 'Felice N', 'Initials': 'FN', 'LastName': 'Jacka', 'Affiliation': 'iMPACT (the Institute for Mental and Physical Health and Clinical Translation), Food & Mood Centre, Deakin University, Health Education and Research Building (HERB), Level 3, PO Box 281, Geelong, VIC3220, Australia.'}]",Public health nutrition,['10.1017/S1368980020003511']
2222,33038521,Randomized clinical trial comparing side to end vs end to end techniques for colorectal anastomosis.,"BACKGROUND


Low anterior resection syndrome affects 60%-90% of patients with anastomoses after colorectal resection. Consensus regarding the best anastomosis is lacking.
OBJECTIVE


To compare outcomes after end-to-end versus side-to-end anastomoses.
DESIGN


Randomized clinical trial.
SETTINGS


University hospital (April 2016-October 2017).
PATIENTS


Patients aged ≥18 years with rectal or sigmoid adenocarcinoma.
INTERVENTIONS


Patients were randomized to undergo mechanical end-to-end or side-to-end (n = 33) anastomosis after laparoscopic resection.
MAIN OUTCOME MEASURES


Primary outcome was to assess intestinal function (COREFO and LARS questionnaires) 12 months after surgery or ileostomy closure. Secondary outcomes were postoperative complications and intestinal function and quality of life (SF-36® questionnaire) at different time points after surgery or ileostomy closure.
RESULTS


No significant differences in intestinal function were observed between the two groups 12 months after surgery. Subanalysis of low-mid rectum tumors with end-to-end anastomosis yielded better function at 12 months. Postoperative complications did not differ between the two groups (p = 0.070), but reinterventions were more common in the side-to-end group (p = 0.040). Multivariate analysis found neoadjuvant treatment was independently associated with intestinal dysfunction at 12 months (β = 0.41, p = 0.033, COREFO; β = 0.41, p = 0.024, LARS).
CONCLUSIONS


End-to-end anastomosis yielded low rates of severe complications and reintervention, as well as better intestinal function at 12 months in the subgroup with tumors in the low-mid rectum.
TRIAL REGISTRATION


clinicaltrials.gov identifier: NCT02746224.",2020,"Postoperative complications did not differ between the two groups (p=0.070), but reinterventions were more common in the side-to-end group (p=0.040).","['Patients aged ≥18 years with rectal or sigmoid adenocarcinoma', 'colorectal anastomosis', 'patients with anastomoses after colorectal resection', 'University hospital (April 2016-October 2017']",['mechanical end-to-end or side-to-end (n=33) anastomosis after laparoscopic resection'],"['intestinal function', 'intestinal function (COREFO and LARS questionnaires) 12 months after surgery or ileostomy closure', 'Postoperative complications', 'intestinal dysfunction', 'postoperative complications and intestinal function and quality of life (SF-36® questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0227391', 'cui_str': 'Sigmoid colon structure'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0278307', 'cui_str': 'Coloproctostomy'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0192866', 'cui_str': 'Sigmoid colectomy'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0192775', 'cui_str': 'Closure of ileostomy'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.197003,"Postoperative complications did not differ between the two groups (p=0.070), but reinterventions were more common in the side-to-end group (p=0.040).","[{'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Planellas', 'Affiliation': 'Department of Surgery, Dr Josep Trueta University Hospital, Girona, Spain; Department of Medical Sciences, Faculty of Medicine, University of Girona, Girona, Spain; Girona Biomedical Research Institute (IDIBGI), Girona, Spain. Electronic address: pplanellas.girona.ics@gencat.cat.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Farrés', 'Affiliation': 'Department of Surgery, Dr Josep Trueta University Hospital, Girona, Spain; Department of Medical Sciences, Faculty of Medicine, University of Girona, Girona, Spain; Girona Biomedical Research Institute (IDIBGI), Girona, Spain.'}, {'ForeName': 'Lídia', 'Initials': 'L', 'LastName': 'Cornejo', 'Affiliation': 'Girona Biomedical Research Institute (IDIBGI), Girona, Spain.'}, {'ForeName': 'Jose Ignacio', 'Initials': 'JI', 'LastName': 'Rodríguez-Hermosa', 'Affiliation': 'Department of Surgery, Dr Josep Trueta University Hospital, Girona, Spain; Department of Medical Sciences, Faculty of Medicine, University of Girona, Girona, Spain; Girona Biomedical Research Institute (IDIBGI), Girona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pigem', 'Affiliation': 'Department of Surgery, Dr Josep Trueta University Hospital, Girona, Spain; Department of Medical Sciences, Faculty of Medicine, University of Girona, Girona, Spain; Girona Biomedical Research Institute (IDIBGI), Girona, Spain.'}, {'ForeName': 'Ander', 'Initials': 'A', 'LastName': 'Timoteo', 'Affiliation': 'Department of Surgery, Dr Josep Trueta University Hospital, Girona, Spain; Department of Medical Sciences, Faculty of Medicine, University of Girona, Girona, Spain; Girona Biomedical Research Institute (IDIBGI), Girona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Ortega', 'Affiliation': 'Department of Surgery, Dr Josep Trueta University Hospital, Girona, Spain; Department of Medical Sciences, Faculty of Medicine, University of Girona, Girona, Spain; Girona Biomedical Research Institute (IDIBGI), Girona, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Codina-Cazador', 'Affiliation': 'Department of Surgery, Dr Josep Trueta University Hospital, Girona, Spain; Department of Medical Sciences, Faculty of Medicine, University of Girona, Girona, Spain; Girona Biomedical Research Institute (IDIBGI), Girona, Spain.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.09.039']
2223,33040821,Efficacy of low-dose insulin combined with electrolyte in the treatment of pediatric diabetic ketoacidosis and its effect on serum inflammatory factors.,"Diabetic ketoacidosis (DKA) is a very serious disease that can occur in both types of diabetes (type 1 and 2). It is caused by a combination of high blood sugar and low insulin levels, which can cause the body to produce too much ketone. Ketones are toxic to human organs. This research aimed to investigate the clinical efficacy of low-dose insulin combined with electrolyte in the treatment of pediatric DKA and its effect on serum inflammatory factors. For this purpose, a total of 122 children with DKA admitted to our hospital from April 2013 to May 2016 were selected as research objects. They were divided into group A with 60 cases and group B with 62 cases. Group B was treated with supplemental electrolytes, and group A was treated with low-dose insulin based on group B. The serum levels of TNF-α, IL-6, and IL-18 were measured by enzyme-linked immunosorbent assay (ELISA) before and after treatment, and the blood sugar, sodium, and potassium levels were measured by an automatic biochemical analyzer. The time when blood sugar reached the standard level when acidosis was corrected and hospitalization time was compared between the two groups. The total effective rate of group A was significantly higher than that of group B (p&lt; 0.05). There was no significant difference in blood glucose, sodium, potassium, TNF-α, IL-6, and IL-18 levels between the two groups before treatment. (all p &gt; 0.05). But the blood glucose, sodium and potassium levels in group A were significantly better than those in group B (all p&lt; 0.001). The levels of serum TNF-α, IL-6, and IL-18 in group A were significantly lower than those in group B after treatment (all p&lt; 0.001). After treatment, the time when blood sugar reached the standard level when acidosis was corrected and hospitalization time in group A were significantly shorter than those in group B (all p&lt; 0.001). Low-dose insulin combined with electrolyte supplementation is effective in the treatment of DKA in children, which can effectively control blood sugar, sodium, potassium level, and inflammatory factor concentration.",2020,The total effective rate of group A was significantly higher than that of group B (p&lt; 0.05).,"['pediatric diabetic ketoacidosis', 'Diabetic ketoacidosis (DKA', '122 children with DKA admitted to our hospital from April 2013 to May 2016 were selected as research objects']","['electrolyte supplementation', 'low-dose insulin combined with electrolyte', 'supplemental electrolytes']","['blood sugar, sodium, and potassium levels', 'total effective rate', 'serum inflammatory factors', 'blood glucose, sodium, potassium, TNF-α, IL-6, and IL-18 levels', 'blood glucose, sodium and potassium levels', 'levels of serum TNF-α, IL-6, and IL-18', 'serum levels of TNF-α, IL-6, and IL-18', 'hospitalization time']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}]","[{'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0202194', 'cui_str': 'Potassium measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",122.0,0.0142822,The total effective rate of group A was significantly higher than that of group B (p&lt; 0.05).,"[{'ForeName': 'Meili', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'Department of Pediatrics, Zibo Central Hospital, Zibo 255000, China.'}, {'ForeName': 'Lihe', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Department of Pediatrics, Jinan City Laigang Hospital, Jinan 271100, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Pediatrics, Qingdao Municipal Hospital, Qingdao 266011, China.'}]","Cellular and molecular biology (Noisy-le-Grand, France)",[]
2224,33040841,Investigations on dose proportionality and drug-drug interaction for a fixed-dose combination of trazodone and gabapentin.,"OBJECTIVES


To establish dose proportionality for trazodone and gabapentin at fixed ratios of trazodone/gabapentin 2.5/25, 10/100, and 30/300 and investigation of potential drug-drug interaction at a dose of 10/100.
MATERIALS AND METHODS


29 out of 30 healthy subjects completed this single-center, open-label, randomized, 5-period cross-over trial with single-dose fasted administrations. Administrations were separated by a washout period of at least 6 days. Blood samples were drawn until 48 hours post dose. A validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS) was applied for determination of trazodone and gabapentin in plasma. The lower limits of quantitation (LLOQ) were 1.00 ng/mL and 5.00 ng/mL for trazodone and gabapentin, respectively. Adverse events (AEs) were analyzed in the study population descriptively.
RESULTS


Plasma concentrations were characterized thoroughly. For trazodone, assessment of proportionality (power model/pairwise-comparison by ANOVA) showed proportionality for AUC over all doses and for C max  between the middle and high dose. For gabapentin, a less than proportional increase in both metrices was present with a likely proportional increase from 25 to 100 mg only. Considering common bioequivalence criteria, absence of pharmacokinetic interaction was confirmed comparing the combination and individual agents. 23 subjects experienced 53 AEs during the trial, the most frequent being fatigue (20 cases/15 subjects) and dizziness (14 cases/11 subjects). No serious AEs were reported.
CONCLUSION


To our knowledge, for the first time, proportionality for trazodone at doses of 2.5 to 30 mg and for gabapentin at doses of 25 to 300 mg was investigated. Absence of a pharmacokinetic interaction was shown.",2020,"For trazodone, assessment of proportionality (power model/pairwise-comparison by ANOVA) showed proportionality for AUC over all doses and for C max  between the middle and high dose.","['29 out of 30 healthy subjects', '23 subjects experienced 53 AEs during the trial, the most frequent being fatigue (20 cases/15 subjects) and dizziness (14 cases/11 subjects']","['gabapentin', 'trazodone and gabapentin', 'trazodone/gabapentin']","['lower limits of quantitation (LLOQ', 'Adverse events (AEs']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0040805', 'cui_str': 'Trazodone'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",30.0,0.0434538,"For trazodone, assessment of proportionality (power model/pairwise-comparison by ANOVA) showed proportionality for AUC over all doses and for C max  between the middle and high dose.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Ruggieri', 'Affiliation': ''}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Picollo', 'Affiliation': ''}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Del Vecchio', 'Affiliation': ''}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Calisti', 'Affiliation': ''}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Dragone', 'Affiliation': ''}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Comandini', 'Affiliation': ''}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Rosignoli', 'Affiliation': ''}, {'ForeName': 'Agnese', 'Initials': 'A', 'LastName': 'Cattaneo', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Donath', 'Affiliation': ''}, {'ForeName': 'Ralph-Steven', 'Initials': 'RS', 'LastName': 'Wedemeyer', 'Affiliation': ''}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Todorova-Sanjari', 'Affiliation': ''}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Warnke', 'Affiliation': ''}, {'ForeName': 'Henning H', 'Initials': 'HH', 'LastName': 'Blume', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203845']
2225,33040926,Comparison between core exercise program with pilates exercise program in weight changes in overweight students.,"OBJECTIVE


To compare the effectiveness of core exercise program and pilates exercise program for weight changes in nursing students Hasanuddin University.
METHOD


This study uses an experimental method with a research design using two group pretest-posttest design. This research was conducted by providing core and pilates exercises given to 30 samples divided into 2 groups, namely the core group and the pilates group. Samples were measured by weight using kg (kilogram) scales to get the pre-test results. The exercises was given 12 times. After being given exercise, then the weight was measured again as a post-test result.
RESULT


The results of data analysis using paired sample t-test showed a value of p=0.00 (p<0.05) so that the conclusion was that there were significant changes before and after giving core exercise and pilates exercise and the value of change for the core group was 2.46 and the value of change for the pilates group is 1.60 so it can be interpreted that core exercise is more effective in efforts to change the weight of overweight students at the Faculty of Nursing Hasanuddin University.",2020,The results of data analysis using paired sample t-test showed a value of p=0.00 (p<0.05) so that the conclusion was that there were significant changes before and after giving core exercise and pilates exercise and the value of change for the core group was 2.46 and the value of change for the pilates group is 1.60 so it can be interpreted that core exercise is more effective in efforts to change the weight of overweight students at the Faculty of Nursing Hasanuddin University.,"['overweight students', 'nursing students Hasanuddin University']","['core exercise program with pilates exercise program', 'core exercise program and pilates exercise program']",['weight changes'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1321049', 'cui_str': 'Pilates exercise'}]","[{'cui': 'C0005911', 'cui_str': 'Weight change'}]",,0.0172974,The results of data analysis using paired sample t-test showed a value of p=0.00 (p<0.05) so that the conclusion was that there were significant changes before and after giving core exercise and pilates exercise and the value of change for the core group was 2.46 and the value of change for the pilates group is 1.60 so it can be interpreted that core exercise is more effective in efforts to change the weight of overweight students at the Faculty of Nursing Hasanuddin University.,"[{'ForeName': 'Fadhia', 'Initials': 'F', 'LastName': 'Adliah', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Hasanuddin University, Makassar, South Sulawesi, Indonesia. Electronic address: fadhiaadliah@unhas.ac.id.'}, {'ForeName': 'Arini', 'Initials': 'A', 'LastName': 'Puspita', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Hasanuddin University, Makassar, South Sulawesi, Indonesia.'}, {'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Sutono', 'Affiliation': 'Department of Physiotherapy, Hasanuddin University Hospital, Makassar, South Sulawesi, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.06.067']
2226,33040934,The effect of prenatal yoga on the anxiety level of pregnant women.,"OBJECTIVE


This study was to determine the effect of prenatal yoga on the anxiety level of third trimesters pregnant women in the Singgani Health Center before and after being given yoga pregnancy.
METHOD


The method in this study is a type of pre-experimental research that uses the one group pre-test - post-test approach. The samples in this study were 48 subjects using a purposive sampling technique. Prenatal yoga was given to third trimesters pregnancy gestational weeks 30-37 age; the level of anxiety of pregnant women was measured by Interviews using questionnaires. Analysis in the study used the Wilcoxon test.
RESULTS


Before the intervention of yoga, pregnancy has severe anxiety that is equal to 58.3%, mothers who are not anxious 2.1%, mild anxiety levels 2.1%, mothers who have moderate anxiety levels of 37.5%. After pregnancy yoga, most mothers had a mild anxiety level of 54.1%, mothers who did not have the anxiety of 16.7%, and mothers who had moderate and severe anxiety levels of 14.6% each. Wilcoxon test showed significant statistics.
CONCLUSION


This study indicated that prenatal yoga could influence the anxiety level of pregnant women.",2020,"After pregnancy yoga, most mothers had a mild anxiety level of 54.1%, mothers who did not have the anxiety of 16.7%, and mothers who had moderate and severe anxiety levels of 14.6% each.","['pregnant women', 'third trimesters pregnant women in the Singgani Health Center before and after being given yoga pregnancy', '48 subjects using a purposive sampling technique']","['prenatal yoga', 'Prenatal yoga']","['severe anxiety levels', 'severe anxiety', 'anxiety level', 'moderate anxiety levels', 'mild anxiety level', 'mild anxiety levels']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0231403', 'cui_str': 'Severe anxiety (panic)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0231402', 'cui_str': 'Moderate anxiety'}, {'cui': 'C0231401', 'cui_str': 'Mild anxiety'}]",48.0,0.0430631,"After pregnancy yoga, most mothers had a mild anxiety level of 54.1%, mothers who did not have the anxiety of 16.7%, and mothers who had moderate and severe anxiety levels of 14.6% each.","[{'ForeName': 'Pont Anna', 'Initials': 'PA', 'LastName': 'Veronica', 'Affiliation': 'Politeknik Kesehatan Kementerian Kesehatan Palu, Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Enggar', 'Affiliation': 'Akademi Kebidanan Palu, Sulawesi Tengah, Indonesia.'}, {'ForeName': 'Gintoe Hermin', 'Initials': 'GH', 'LastName': 'Lastri', 'Affiliation': 'Akademi Kebidanan Palu, Sulawesi Tengah, Indonesia.'}, {'ForeName': 'Sitti', 'Initials': 'S', 'LastName': 'Rafiah', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Indonesia. Electronic address: sittirafiah@pasca.unhas.ac.id.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.06.074']
2227,33040941,Effect of healthy living behaviour on physical fitness.,"OBJECTIVE


This study aims to determine how much influence the behaviour of healthy living on physical fitness.
METHOD


This research method is research Quasi-Experimental Design using One-Group Pretest-Posttest Design. With a total sample of 90 people.
RESULT


Based on the results of the analysis of the statistical data obtained, the Sig. (2-tailed)= 0.000, then Sig. (2-tailed) <0.05, therefore, H 0  is rejected and H 1  accepted.
CONCLUSION


So it was concluded that there was a significant influence on healthy behaviour on physical fitness of physical education, health and recreation students at Musamus University.",2020,"So it was concluded that there was a significant influence on healthy behaviour on physical fitness of physical education, health and recreation students at Musamus University.","['healthy living behaviour on physical fitness', 'With a total sample of 90 people']",[],[],"[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],[],90.0,0.0159419,"So it was concluded that there was a significant influence on healthy behaviour on physical fitness of physical education, health and recreation students at Musamus University.","[{'ForeName': 'Jori', 'Initials': 'J', 'LastName': 'Lahinda', 'Affiliation': 'Department of Physical Education, Health and Recreation, Faculty of Teacher Training and Education, Musamus University, Merauke, Indonesia. Electronic address: jorilahinda@gmail.com.'}, {'ForeName': 'Pulung', 'Initials': 'P', 'LastName': 'Riyanto', 'Affiliation': 'Department of Physical Education, Health and Recreation, Faculty of Teacher Training and Education, Musamus University, Merauke, Indonesia.'}, {'ForeName': 'Arifin Ika', 'Initials': 'AI', 'LastName': 'Nugroho', 'Affiliation': 'Department of Physical Education, Health and Recreation, Faculty of Teacher Training and Education, Musamus University, Merauke, Indonesia.'}, {'ForeName': 'Syahrir A', 'Initials': 'SA', 'LastName': 'Pasinringi', 'Affiliation': 'Faculty of Public Health, Hasanuddin University, Makassar, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.06.013']
2228,33040944,Effect of elderly senny to elderly fitness.,"OBJECTIVE


Physical fitness becomes the most important factor in life, it is also undeniable that maintaining physical fitness in the elderly becomes very important. Many ways are used in maintaining physical fitness in the elderly, one of them by using elderly exercise.
METHODS


The method used with quasi-experimental, with the research design ""Pretest-Posttes With Control Group Design. The population in this study is the elderly in Posyandu Mekarjaya 2 with a population of 30 people. The sampling technique used in this study is to use the purposive sampling technique. Tests and measurements in this study used the Six Minutes Walking Test instrument.
RESULTS


Based on the analysis of the differences in physical fitness results between the experimental and control groups, the Sig. (2-tailed)=0.006. Thus, the elderly exercise has a significant impact on improving the physical fitness of the elderly. The results of this study can provide information about the benefits of elderly exercise on the fitness level of the elderly by doing elderly exercise regularly. One that can be used in improving the physical fitness of the elderly is to use the elderly exercise.
CONCLUSION


Based on the calculation results it can be concluded that the elderly exercise gives an impact on the physical disability of the elderly. Then to improve physical fitness in the elderly it is advisable to use the elderly exercise.",2020,Based on the calculation results it can be concluded that the elderly exercise gives an impact on the physical disability of the elderly.,"['elderly in Posyandu Mekarjaya 2 with a population of 30 people', 'elderly senny to elderly fitness']",['elderly exercise'],['physical fitness'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",30.0,0.00976161,Based on the calculation results it can be concluded that the elderly exercise gives an impact on the physical disability of the elderly.,"[{'ForeName': 'Pulung', 'Initials': 'P', 'LastName': 'Riyanto', 'Affiliation': 'Department of Physical Education Health and Recreation, Faculty of Teacher Training and Education, Universitas Musamus, Indonesia. Electronic address: riyanto_fkip@unmus.ac.id.'}, {'ForeName': 'Jori', 'Initials': 'J', 'LastName': 'Lahinda', 'Affiliation': 'Department of Physical Education Health and Recreation, Faculty of Teacher Training and Education, Universitas Musamus, Indonesia.'}, {'ForeName': 'Arifin Ika', 'Initials': 'AI', 'LastName': 'Nugroho', 'Affiliation': 'Department of Physical Education Health and Recreation, Faculty of Teacher Training and Education, Universitas Musamus, Indonesia.'}, {'ForeName': 'Serli Hatul', 'Initials': 'SH', 'LastName': 'Hidayat', 'Affiliation': 'Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.06.016']
2229,33041145,Comparison of ibuprofen and piroxicam gel in the treatment of trauma pain: A randomized double-blind trial of geriatric population.,"OBJECTIVE


This study aimed to compare the analgesic efficacy of topical ibuprofen and topical piroxicam for acute musculoskeletal injuries.
METHODS


In this prospective, randomized, controlled, double-blinded study, geriatric patients were assigned to groups to receive either topical ibuprofen (n = 70) or topical piroxicam (n = 69). The first dose of gel was applied in the emergency department and the remaining doses were self-administered at home by the patients thrice daily for 72 h. For each patient, the initial baseline visual analog scale (VAS) score (V 0) was compared with the VAS scores at the 60 min (V1), 120 min (V2), 24 h (V3) and 72 h (V4) time points. The decreases in VAS scores, clinical effectiveness of the treatments, and incidence of adverse events were evaluated.
RESULTS


In the topical ibuprofen group, the VAS scores were significantly lower at each measurement time point compared to baseline (p < .001). The results were as follows: V0 -V: 1.08, 95% CI: 0.56-1.61; V0 -V2: 1.09, 95% CI: 0.49-1.69; V0 -V3: 1.44, 95% CI: 0.81-2.07; V0 -V4: 1.59, 95% CI: 0.91-2.26. The mean percentage decrease in the VAS scores in the topical ibuprofen group was significantly higher than that in the topical piroxicam group (p < .001). The clinical effect of treatment was found to be significantly higher for the ibuprofen gel group (p < .001). There was no substantial difference in treatment-related adverse events between the groups (p > .05).
CONCLUSION


Ibuprofen gel, which is a safe treatment option for geriatric patients, is more clinically effective than piroxicam gel. Response to Reviewers.",2020,"In the topical ibuprofen group, the VAS scores were significantly lower at each measurement time point compared to baseline (p < .001).","['geriatric population', 'geriatric patients', 'trauma pain']","['ibuprofen and piroxicam gel', 'Ibuprofen gel', 'topical ibuprofen', 'piroxicam gel', 'topical piroxicam', 'topical ibuprofen and topical piroxicam']","['VAS scores', 'adverse events', 'initial baseline visual analog scale (VAS) score', 'VAS scores, clinical effectiveness of the treatments, and incidence of adverse events', 'analgesic efficacy']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0031990', 'cui_str': 'Piroxicam'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0360483', 'cui_str': 'Ibuprofen-containing product in cutaneous dose form'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.108007,"In the topical ibuprofen group, the VAS scores were significantly lower at each measurement time point compared to baseline (p < .001).","[{'ForeName': 'Sinem', 'Initials': 'S', 'LastName': 'Dogruyol', 'Affiliation': 'Department of Emergency Medicine, Manisa Merkez Efendi State Hospital, Manisa, Turkey.'}, {'ForeName': 'Abdullah Osman', 'Initials': 'AO', 'LastName': 'Kocak', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Akbas', 'Affiliation': 'Department of Emergency Medicine, Bingol State Hospital, Bingol, Turkey. Electronic address: akbasilker@gmail.com.'}, {'ForeName': 'Tugba Sanalp', 'Initials': 'TS', 'LastName': 'Menekse', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Sultan Tuna Akgol', 'Initials': 'STA', 'LastName': 'Gur', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Talha', 'Initials': 'T', 'LastName': 'Dogruyol', 'Affiliation': 'Department of Thoracic Surgery, Manisa City Hospital, Manisa, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Cakir', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.08.041']
2230,33041146,MAGraine: Magnesium compared to conventional therapy for treatment of migraines.,"Due to the healthcare burden associated with migraines, prompt and effective treatment is vital to improve patient outcomes and ED workflow. This was a prospective, randomized, double-blind trial. Adults who presented to the ED with a diagnosis of migraine from August of 2019 to March of 2020 were included. Pregnant patients, or with renal impairment were excluded. Patients were randomized to receive intravenous magnesium, prochlorperazine, or metoclopramide. The primary outcome was change in pain from baseline on a numeric rating scale (NRS) evaluated at 30 min after initiation of infusion of study drug. Secondary outcomes included NRS at 60 and 120 min, ED length of stay, necessity for rescue analgesia, and adverse effects. A total of 157 patients were analyzed in this study. Sixty-one patients received magnesium, 52 received prochlorperazine, and 44 received metoclopramide. Most patients were white females, and the median age was 36 years. Hypertension and migraines were the most common comorbidities, with a third of the patients reporting an aura. There was a median decrease in NRS at 30 min of three points across all three treatment arms. The median decrease in NRS (IQR) at 60 min was -4 (2-6) in the magnesium group, -3 (2-5) in the metoclopramide group, and -4.5 (2-7) in the prochlorperazine group (p = 0.27). There were no statistically significant differences in ED length of stay, rescue analgesia, or adverse effects. Reported adverse effects were dizziness, anxiety, and akathisia. No significant difference was observed in NRS at 30 min between magnesium, metoclopramide and prochlorperazine.",2020,"No significant difference was observed in NRS at 30 min between magnesium, metoclopramide and prochlorperazine.","['migraines', 'Most patients were white females, and the median age was 36\xa0years', 'Adults who presented to the ED with a diagnosis of migraine from August of 2019 to March of 2020 were included', 'Pregnant patients, or with renal impairment were excluded', 'A total of 157 patients']","['magnesium', 'magnesium, metoclopramide', 'conventional therapy', 'metoclopramide', 'prochlorperazine', 'MAGraine: Magnesium', 'intravenous magnesium, prochlorperazine, or metoclopramide']","['NRS', 'numeric rating scale (NRS', 'Hypertension and migraines', 'ED length of stay, rescue analgesia, or adverse effects', 'dizziness, anxiety, and akathisia', 'median decrease in NRS (IQR', 'NRS at 60 and 120\xa0min, ED length of stay, necessity for rescue analgesia, and adverse effects', 'change in pain']","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0910435', 'cui_str': 'AM 36'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033229', 'cui_str': 'Prochlorperazine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",157.0,0.542968,"No significant difference was observed in NRS at 30 min between magnesium, metoclopramide and prochlorperazine.","[{'ForeName': 'Manar', 'Initials': 'M', 'LastName': 'Kandil', 'Affiliation': 'Department of Pharmacy, Advocate Christ Medical Center, Oak Lawn, IL, United States of America. Electronic address: manar.kandil87@gmail.com.'}, {'ForeName': 'Sabrin', 'Initials': 'S', 'LastName': 'Jaber', 'Affiliation': 'Department of Pharmacy, Advocate Christ Medical Center, Oak Lawn, IL, United States of America.'}, {'ForeName': 'Dharati', 'Initials': 'D', 'LastName': 'Desai', 'Affiliation': 'Department of Pharmacy, Advocate Christ Medical Center, Oak Lawn, IL, United States of America.'}, {'ForeName': 'Stephany', 'Initials': 'S', 'LastName': 'Nuñez Cruz', 'Affiliation': 'Department of Pharmacy, Advocate Christ Medical Center, Oak Lawn, IL, United States of America.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Lomotan', 'Affiliation': 'Department of Pharmacy, Advocate Christ Medical Center, Oak Lawn, IL, United States of America.'}, {'ForeName': 'Uzma', 'Initials': 'U', 'LastName': 'Ahmad', 'Affiliation': 'Department of Emergency Medicine, Advocate Christ Medical Center, Oak Lawn, IL, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cirone', 'Affiliation': 'Department of Emergency Medicine, Advocate Christ Medical Center, Oak Lawn, IL, United States of America.'}, {'ForeName': 'Jaxson', 'Initials': 'J', 'LastName': 'Burkins', 'Affiliation': 'Department of Pharmacy, Advocate Christ Medical Center, Oak Lawn, IL, United States of America.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'McDowell', 'Affiliation': 'Department of Pharmacy, Advocate Christ Medical Center, Oak Lawn, IL, United States of America.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.09.033']
2231,33041172,Randomized Controlled Trial of Sensor-Guided Knee Balancing Compared to Standard Balancing Technique in Total Knee Arthroplasty.,"BACKGROUND


Despite advances in total knee arthroplasty (TKA) technology, up to 1 in 5 patients remain dissatisfied. This study sought to evaluate if sensor-guided knee balancing improves postoperative clinical outcomes and patient satisfaction compared to a conventional gap balancing technique.
METHODS


We undertook a prospective double-blind randomized controlled trial of patients presenting for elective primary TKA to determine a difference in TKA soft tissue balance between a standard gap balancing (tensiometer) approach compared to augmenting the balance using a sensor-guided device. The sensor-guided experimental group had adjustments made to achieve a balanced knee to within 15 pounds of intercompartmental pressure difference. Secondary outcomes included differences in clinical outcome scores at 6 months and 1 year postoperative, including the Oxford Knee Score and Knee Society Score and patient satisfaction.
RESULTS


The sample comprised of 152 patients, 76 controls and 76 experimental sensor-guided cases. Within the control group, 36% (27/76) of knees were unbalanced based on an average coronal plane intercompartmental difference >15 pounds, compared to only 5.3% (4/76) within the experimental group (P < .0001). There were no significant differences in 1-year postoperative flexion, Knee Society Score, or Oxford scores. Overall, TKA patient satisfaction at 1 year was comparable, with 81% of controls and experimental cases reporting they were very satisfied (P = .992).
CONCLUSION


Despite the use of the sensor-guided knee balancer device to provide additional quantitative feedback in the evaluation of the soft tissue envelope during TKA, we were unable to demonstrate improved clinical outcomes or patient satisfaction compared to our conventional gap balancing technique.",2020,"There were no significant differences in 1-year postoperative flexion, Knee Society Score, or Oxford scores.","['152 patients, 76 controls and 76 experimental sensor-guided cases', '5 patients remain dissatisfied', 'Total Knee Arthroplasty', 'patients presenting for elective primary TKA']","['standard gap balancing (tensiometer) approach', 'conventional gap balancing technique', 'Sensor-Guided Knee Balancing Compared to Standard Balancing Technique', 'sensor-guided knee balancing', 'TKA']","['Overall, TKA patient satisfaction', '1-year postoperative flexion, Knee Society Score, or Oxford scores', 'postoperative clinical outcomes and patient satisfaction', 'TKA soft tissue balance', 'clinical outcomes or patient satisfaction', 'clinical outcome scores at 6 months and 1 year postoperative, including the Oxford Knee Score and Knee Society Score and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}]",152.0,0.1964,"There were no significant differences in 1-year postoperative flexion, Knee Society Score, or Oxford scores.","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Wood', 'Affiliation': 'Division of Orthopaedic Surgery, McMaster University, Hamilton, Ontario, Canada; Complex Care and Orthopaedics Program, Hamilton Health Sciences Juravinski Hospital, Hamilton, Ontario, Canada; Hamilton Arthroplasty Group, Hamilton Health Sciences Juraviski Hospital, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Winemaker', 'Affiliation': 'Division of Orthopaedic Surgery, McMaster University, Hamilton, Ontario, Canada; Complex Care and Orthopaedics Program, Hamilton Health Sciences Juravinski Hospital, Hamilton, Ontario, Canada; Hamilton Arthroplasty Group, Hamilton Health Sciences Juraviski Hospital, Hamilton, Ontario, Canada.'}, {'ForeName': 'Dale S', 'Initials': 'DS', 'LastName': 'Williams', 'Affiliation': 'Division of Orthopaedic Surgery, McMaster University, Hamilton, Ontario, Canada; Complex Care and Orthopaedics Program, Hamilton Health Sciences Juravinski Hospital, Hamilton, Ontario, Canada; Hamilton Arthroplasty Group, Hamilton Health Sciences Juraviski Hospital, Hamilton, Ontario, Canada.'}, {'ForeName': 'Danielle T', 'Initials': 'DT', 'LastName': 'Petruccelli', 'Affiliation': 'Complex Care and Orthopaedics Program, Hamilton Health Sciences Juravinski Hospital, Hamilton, Ontario, Canada; Hamilton Arthroplasty Group, Hamilton Health Sciences Juraviski Hospital, Hamilton, Ontario, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Tushinski', 'Affiliation': 'Division of Orthopaedic Surgery, McMaster University, Hamilton, Ontario, Canada; Complex Care and Orthopaedics Program, Hamilton Health Sciences Juravinski Hospital, Hamilton, Ontario, Canada; Hamilton Arthroplasty Group, Hamilton Health Sciences Juraviski Hospital, Hamilton, Ontario, Canada.'}, {'ForeName': 'Justin de V', 'Initials': 'JV', 'LastName': 'de Beer', 'Affiliation': 'Division of Orthopaedic Surgery, McMaster University, Hamilton, Ontario, Canada; Complex Care and Orthopaedics Program, Hamilton Health Sciences Juravinski Hospital, Hamilton, Ontario, Canada; Hamilton Arthroplasty Group, Hamilton Health Sciences Juraviski Hospital, Hamilton, Ontario, Canada.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.09.025']
2232,33041430,Adolescents with autism spectrum disorder and social skills groups at school: A randomized trial comparing intervention environment and peer composition.,"This study used a randomized controlled trial to compare two distinct models of group social skills interventions with adolescents with autism spectrum disorder (ASD). Participants had a confirmed diagnosis of ASD, an IQ greater than or equal to 70, and were educated in the general education setting. Data from 62 adolescent participants who were randomized to one of two treatment conditions (SKILLS vs. ENGAGE) were analyzed. SKILLS participants had a diagnosis of ASD, or social difficulties. ENGAGE groups included adolescents with ASD and typically developing (TD) peer mentors. SKILLS and ENGAGE participants both improved joint engagement and reduced solitary engagement, however, SKILLS participants reported higher social stress and lower quality interpersonal relationships at exit, and increased emotional symptoms and problem behaviors at follow-up compared to the ENGAGE group. The findings suggest that within inclusive secondary school settings, it may be beneficial to include TD peers in social intervention groups.",2020,"SKILLS and ENGAGE participants both improved joint engagement and reduced solitary engagement, however, SKILLS participants reported higher social stress and lower quality interpersonal relationships at exit, and increased emotional symptoms and problem behaviors at follow-up compared to the ENGAGE group.","['adolescents with ASD and typically developing (TD) peer mentors', '62 adolescent participants', 'Adolescents with autism spectrum disorder and social skills groups at school', 'Participants had a confirmed diagnosis of ASD, an IQ greater than or equal to 70, and were educated in the general education setting', 'adolescents with autism spectrum disorder (ASD']","['social skills interventions', 'intervention environment and peer composition']","['emotional symptoms and problem behaviors', 'joint engagement and reduced solitary engagement', 'social stress and lower quality interpersonal relationships', 'diagnosis of ASD, or social difficulties']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",62.0,0.0659458,"SKILLS and ENGAGE participants both improved joint engagement and reduced solitary engagement, however, SKILLS participants reported higher social stress and lower quality interpersonal relationships at exit, and increased emotional symptoms and problem behaviors at follow-up compared to the ENGAGE group.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Dean', 'Affiliation': 'California State University - Channel Islands.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'University of California Los Angeles.'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Orlich', 'Affiliation': ""Seattle Children's Autism Center.""}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Kasari', 'Affiliation': 'University of California Los Angeles.'}]",School psychology review,['10.1080/2372966x.2020.1716636']
2233,33041442,Effect of Intravenous Abciximab on Coronary Flow Improvement After Re-vascularization in Primary Coronary Intervention and Short Term Impact.,"Introduction


Of recognized fact the importance of early diagnosis and early management of ST-elevation myocardial infarction, to regain a normal or at least adequate coronary flow in the Primary Percutaneous Intervention. Slow or no-reflow is suboptimal myocardial reperfusion, without angiographic evidence of mechanical obstruction. Adenosine, Verapamil and saline flush are manoeuvres proved useful. The resolution of ST-segment is associated with successful revascularization and regarded as a predictor for future events. Glycoprotein IIB/IIIA inhibitors are a group of anti-platelets widely used in acute coronary syndrome.
Aim


The aim of the study was to investigate that: uses of intra venous Abciximab, does not improve coronary flow in patients with MI that develop sub optimal flow after primary PCI within 30 minutes, but the improvement need 12 to 24 hour as founded in other studies, and its beneficial effect is related to early improvement in LV function and decrease of re-infarction and re-hospitalization.
Method


Prospective, case-control study, enrolled fifty patients randomly assigned into two matching groups, first group (25 patients) received an intravenous Abciximab while the second group (25 patients) received intracoronary saline flush. Repeated angiography after 30 minutes, for immediate resultant flow assessment, Electrocardiographic changes resolution, bleeding and death. After a 30 days, a clinical assessment for primary outcome including, death, recurrent Myocardial infarction and Heart failure While the Secondary outcome including stent thrombosis, target vessel revascularization in addition to the primary outcome.
Result


There was no significant difference in the flow Improvement and ECG resolution between both groups. These findings not affected by the door to balloon time. However, patients with flow improvement had a significant resolution in their ECG. Bleeding propensity and mortality were not significantly affected. Literatures proved the benefit of Abciximab in acute coronary syndrome.
Conclusion


Both intravenous Abciximab and intracoronary saline flush had comparable effect on coronary flow improvement post primary percutaneous intervention, with minimal variation in the bleeding and in-hospital mortality.",2020,Bleeding propensity and mortality were not significantly affected.,['patients with MI that develop sub optimal flow after primary PCI within 30 minutes'],"['Abciximab', 'Abciximab and intracoronary saline flush', 'Adenosine, Verapamil and saline flush', 'intracoronary saline flush', 'Intravenous Abciximab', 'Glycoprotein IIB/IIIA inhibitors', 'intravenous Abciximab', 'Slow or no-reflow']","['Coronary Flow Improvement', 'Bleeding propensity and mortality', 'Electrocardiographic changes resolution, bleeding and death', 'coronary flow improvement', 'bleeding and in-hospital mortality', 'death, recurrent Myocardial infarction and Heart failure While the Secondary outcome including stent thrombosis, target vessel revascularization in addition to the primary outcome', 'flow Improvement and ECG resolution']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0288672', 'cui_str': 'abciximab'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0016011', 'cui_str': 'Glycoproteins IIb-IIIa'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439834', 'cui_str': 'Slow'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0855329', 'cui_str': 'Electrocardiogram change'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",50.0,0.059176,Bleeding propensity and mortality were not significantly affected.,"[{'ForeName': 'Ahmed N', 'Initials': 'AN', 'LastName': 'Rgeeb', 'Affiliation': 'University of Kufa, Faculty of Medicine, Department of Internal Medicine, Najaf Cardiac Centre, Najaf, Iraq.'}, {'ForeName': 'Hussein A', 'Initials': 'HA', 'LastName': 'Alsalkh', 'Affiliation': 'Faculty of Medicine, University of Kufa, Department of Paediatrics, Al-Zahraa Teaching Hospital, Najaf, Iraq.'}, {'ForeName': 'Ali Kadhim', 'Initials': 'AK', 'LastName': 'Radhi', 'Affiliation': 'Imam Sadeq Hospital, Babylon Health Directorate, Hilla, Babil.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Amber', 'Affiliation': 'Najaf Cardiac Canter, Najaf, Iraq.'}]","Medical archives (Sarajevo, Bosnia and Herzegovina)",['10.5455/medarh.2020.74.265-269']
2234,33041575,Effect of 4% nebulized lignocaine versus 2% nebulized lignocaine for awake fibroscopic nasotracheal intubation in maxillofacial surgeries.,"Introduction


Securing a difficult airway during maxillofacial surgeries is a great challenge for anesthetists, and the flexible fiber-optic bronchoscope is the gold standard while managing such cases. While passing the flexible bronchoscope by the nasal route, the success rate is higher as compared with oral approach as the nasopharynx is in line with the larynx and prevents acute angulation in the oropharynx.
Materials and Methods


A randomized control trial was planned in 73 patients out of whom sixty patients gave consent for the procedure. The patients we randomly divided into two groups ( n  = 30) with application of 4% nebulized lignocaine in one group and the use of 2% nebulized lignocaine in the other group, and the patient's comfort was noted using five-point Puchner scale.
Results


The mean value of patient comfort Puchner scale of Group A was 1.30 ± 0.08 and of Group B was 2.23 ± 0.12. The mean value of Puchner scale of Group B was significantly higher (41.8%) as compared to Group A ( t  = 6.208;  df  = 51;  P  < 0.0001). The secondary outcome measures were optimal intubating conditions and hemodynamic changes during awake fiber-optic nasotracheal intubation. The procedural time of two groups when compared showed that the mean procedural time of Group A was shorter (29.67 ± 5.40 min) than the time consumed in Group B (34.93 ± 5.52 min).
Conclusion


Four percent nebulized lidocaine provided adequate airway anesthesia and optimal intubating conditions along with stable hemodynamics for awake fiber-optic intubation as compared to 2% nebulized lidocaine.",2020,The mean value of Puchner scale of Group B was significantly higher (41.8%) as compared to Group A ( t  = 6.208;  df  = 51;  P  < 0.0001).,"['awake fibroscopic nasotracheal intubation in maxillofacial surgeries', '73 patients out of whom sixty patients gave consent for the procedure']","['nebulized lidocaine', 'nebulized lignocaine']","['optimal intubating conditions and hemodynamic changes during awake fiber-optic nasotracheal intubation', 'mean value of patient comfort Puchner scale', 'mean procedural time', 'mean value of Puchner scale']","[{'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0015979', 'cui_str': 'Fiber Optic Technology'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",73.0,0.034452,The mean value of Puchner scale of Group B was significantly higher (41.8%) as compared to Group A ( t  = 6.208;  df  = 51;  P  < 0.0001).,"[{'ForeName': 'Lohith', 'Initials': 'L', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesiology, KGMU, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Haider', 'Initials': 'H', 'LastName': 'Abbas', 'Affiliation': 'Department of Anaesthesiology, KGMU, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Kothari', 'Affiliation': 'Department of Anaesthesiology, AIIMS, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kohli', 'Affiliation': 'Department of Anaesthesiology, KGMU, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Dhasmana', 'Affiliation': 'Department of Anaesthesiology, KGMU, Lucknow, Uttar Pradesh, India.'}]",National journal of maxillofacial surgery,['10.4103/njms.NJMS_71_17']
2235,33041576,Immediate dental implant placement with or without autogenous bone graft: A comparative study.,"Introduction


Immediate dental implants are the most accepted contemporary treatment option for the replacement of missing teeth. One pitfall of immediate implant use, however, is the inevitable residual space that remains between the implant and the socket wall, called the jumping distance, which may lead to bone resorption and formation of a bony defect, decreasing the implant stability. When this jumping distance is more than 2 mm, use of bone grafts is recommended. However, the use of grafts when the jumping distance is <2 mm is not defined in the literature.
Aim


To evaluate the peri-implant hard and soft tissue changes following immediately placed implants with a jumping distance of 2 mm with or without autogenous bone grafts.
Settings


The study was conducted between January 2016 and December 2017 in the Department of Oral and Maxillofacial Surgery.
Subjects and Methods


This was a prospective, single-center, two-arm, parallel, randomized study on patients undergoing replacement of missing anterior teeth with immediate implants. There were two groups: the study group which received bone graft and the control group which did not receive any graft. Temporary prosthesis was placed following implant placement which was replaced with definitive prosthesis 4 months later. Patients were followed up for a period of 9 months. The alveolar bone loss was evaluated radiologically using cone-beam computed tomography, and pain, suppuration, mobility, and periodontal probing depth were evaluated clinically.
Results


There were 16 participants in the study group and 17 in the control group. The alveolar bone loss was greater in the study group; however, pain, suppuration, and mobility showed no difference between the groups.
Conclusion


The immediate implants placed with or without bone grafts had similar alveolar hard and soft tissue changes when the jumping distance was <2 mm.",2020,"The alveolar bone loss was greater in the study group; however, pain, suppuration, and mobility showed no difference between the groups.
","['patients undergoing replacement of missing anterior teeth with immediate implants', '16 participants in the study group and 17 in the control group', 'Subjects and Methods', 'January 2016 and December 2017 in the Department of Oral and Maxillofacial Surgery']","['immediately placed implants with a jumping distance of 2 mm with or without autogenous bone grafts', 'Immediate dental implant placement with or without autogenous bone graft', 'bone graft and the control group which did not receive any graft']","['pain, suppuration, and mobility', 'pain, suppuration, mobility, and periodontal probing depth', 'alveolar hard and soft tissue changes', 'alveolar bone loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}]","[{'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0440800', 'cui_str': 'Autogenous bone graft'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038862', 'cui_str': 'Suppurative inflammation'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1882337', 'cui_str': 'Periodontal probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0002382', 'cui_str': 'Alveolar bone loss'}]",,0.0411409,"The alveolar bone loss was greater in the study group; however, pain, suppuration, and mobility showed no difference between the groups.
","[{'ForeName': 'Sonalika', 'Initials': 'S', 'LastName': 'Kabi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SCB Dental College and Hospital, Cuttack, Odisha, India.'}, {'ForeName': 'Rosalin', 'Initials': 'R', 'LastName': 'Kar', 'Affiliation': 'Department of Prosthetic Dentistry, SCB Dental College and Hospital, Cuttack, Odisha, India.'}, {'ForeName': 'Dipti', 'Initials': 'D', 'LastName': 'Samal', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SCB Dental College and Hospital, Cuttack, Odisha, India.'}, {'ForeName': 'Kumar C', 'Initials': 'KC', 'LastName': 'Deepak', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SCB Dental College and Hospital, Cuttack, Odisha, India.'}, {'ForeName': 'Indu Bhusan', 'Initials': 'IB', 'LastName': 'Kar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SCB Dental College and Hospital, Cuttack, Odisha, India.'}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Mishra', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SCB Dental College and Hospital, Cuttack, Odisha, India.'}]",National journal of maxillofacial surgery,['10.4103/njms.NJMS_59_19']
2236,33041737,Evaluation of the Dualistic Model of Passion for Alcohol Consumption among Emerging Adults Engaged in Risky Drinking.,"Understanding factors influencing risky drinking among emerging adults could enhance interventions to reduce adverse outcomes. As a motivational construct, the dualistic model of passion (i.e., obsessive passion: drinking is compelling and conflicts with other life activities/values; harmonious passion: drinking is an important, but not overwhelming, part of life) offers a novel explanation for persistent alcohol use. Yet, the dualistic model of passion has not yet been evaluated in this at-risk population. Therefore, we examined whether the variables proposed by the dualistic model of passion were associated with sex, binge-drinking, and alcohol-related consequences among young risky drinkers. We analyzed cross-sectional baseline data collected as part of an ongoing randomized controlled trial of emerging adults (n=327;  M   age =22.6,  SD =1.1, range 21-24; 61% female; 76% White non-Hispanic) engaged in risky drinking (AUDIT-C score ≥ 4 females, ≥ 5 males) recruited nationally via social media advertisements. A path analysis revealed significant positive direct effects between obsessive passion and binge drinking and alcohol-related consequences, and significant negative direct effects between male sex and harmonious passion and binge drinking. There was also a positive direct effect between binge drinking and alcohol-related consequences. Male sex and obsessive passion were both indirectly related to alcohol-related consequences via binge drinking. Type of passion and male sex differentiates risky drinkers who binge drink and who experienced alcohol-related consequences. Future research should examine whether targeting obsessive passion reduces binge drinking and negative outcomes.",2020,"A path analysis revealed significant positive direct effects between obsessive passion and binge drinking and alcohol-related consequences, and significant negative direct effects between male sex and harmonious passion and binge drinking.","['Type of passion and male sex differentiates risky drinkers who binge drink and who experienced alcohol-related consequences', 'young risky drinkers', 'emerging adults (n=327;  M   age =22.6,  SD =1.1, range 21-24; 61% female; 76% White non-Hispanic) engaged in risky drinking (AUDIT-C score ≥ 4 females, ≥ 5 males) recruited nationally via social media advertisements']",[],['Male sex and obsessive passion'],"[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0939808', 'cui_str': 'Passion flower extract'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]",[],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0939808', 'cui_str': 'Passion flower extract'}]",,0.0163117,"A path analysis revealed significant positive direct effects between obsessive passion and binge drinking and alcohol-related consequences, and significant negative direct effects between male sex and harmonious passion and binge drinking.","[{'ForeName': 'Alan K', 'Initials': 'AK', 'LastName': 'Davis', 'Affiliation': 'Behavioral Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD.'}, {'ForeName': 'Brooke J', 'Initials': 'BJ', 'LastName': 'Arterberry', 'Affiliation': 'Department of Psychology, University of Iowa, 901 Stange Road, Ames, IA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Schneeberger', 'Affiliation': 'University of Michigan Addiction Center, Department of Psychiatry, University of Michigan School of Medicine, 4250 Plymouth Road, Ann Arbor, MI.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Bonar', 'Affiliation': 'University of Michigan Addiction Center, Department of Psychiatry, University of Michigan School of Medicine, 4250 Plymouth Road, Ann Arbor, MI.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Bauermeister', 'Affiliation': 'University of Pennsylvania, Department of Family and Community Health, School of Nursing, 418 Curie Blvd., Philadelphia, PA.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Young', 'Affiliation': 'University of California Institute for Prediction Technology, Department of Family Medicine, School of Medicine, University of California, Los Angeles, Los Angeles, CA, 90024.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Cunningham', 'Affiliation': 'University of Michigan Addiction Center, Department of Psychiatry, University of Michigan School of Medicine, 4250 Plymouth Road, Ann Arbor, MI.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Walton', 'Affiliation': 'University of Michigan Addiction Center, Department of Psychiatry, University of Michigan School of Medicine, 4250 Plymouth Road, Ann Arbor, MI.'}]",Addiction research & theory,['10.1080/16066359.2019.1571192']
2237,33041803,The Combination of Propofol and Ketamine Does Not Enhance Clinical Responses to Electroconvulsive Therapy in Major Depression-The Results From the KEOpS Study.,"Objective


We investigated the clinical effects of the combination of ketamine and propofol as anesthetic agents during electroconvulsive therapy (ECT) in patients with uni- or bipolar major depressive episodes. We hypothesized that ketamine may confer short- and long- term advantages in improving depressive symptoms at the early stages of ECT.
Methods


In a randomized placebo-controlled trial, remission rates after 4 and 8 weeks of ECT were compared between patients who were randomly allocated to receive either the combination of ketamine (0.5 mg/kg) + propofol (n= 11) or placebo + propofol (n = 16). Depressive symptoms were assessed weekly using the Montgomery-Åsberg Depression Rating Scale (MADRS); ECT sessions were administered twice per week for a maximum of 8 weeks (16 sessions).
Results


After 4 weeks, we observed significantly fewer remitters (MADRS score < 10) in the ketamine + propofol group (0/11; 0%) than in the placebo + propofol group (5/16; 31%; χ 2  = 4.22; p = 0.040). No significant difference was observed between the two groups regarding the number of patients who achieved remission weekly throughout the study period (Chi² = 3.588; p = 0.058). The mean duration of seizures was significantly shorter in the ketamine + propofol group than in the placebo + propofol group.
Conclusions


The results from the current study corroborated results from previously published studies and did not support the use of the combination of ketamine + propofol as an anesthetic agent for ECT in patients with major depressive episodes in clinical settings.",2020,No significant difference was observed between the two groups regarding the number of patients who achieved remission weekly throughout the study period (Chi² = 3.588; p = 0.058).,"['patients with uni- or bipolar major depressive episodes', 'Major Depression', 'patients with major depressive episodes in clinical settings']","['ECT', 'ketamine and propofol', 'Propofol and Ketamine', 'propofol', 'ketamine', 'placebo', 'placebo + propofol', 'ketamine + propofol', 'electroconvulsive therapy (ECT']","['Montgomery-Åsberg Depression Rating Scale (MADRS); ECT sessions', 'mean duration of seizures', 'depressive symptoms', 'Depressive symptoms', 'remission rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3853222', 'cui_str': 'Sea urchin - dietary'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0730597', 'cui_str': 'Duration of seizure'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.183799,No significant difference was observed between the two groups regarding the number of patients who achieved remission weekly throughout the study period (Chi² = 3.588; p = 0.058).,"[{'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Brunelin', 'Affiliation': 'CH Le Vinatier, Bron, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Iceta', 'Affiliation': 'CH Le Vinatier, Bron, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Plaze', 'Affiliation': 'GHU Paris Psychiatrie et Neurosciences, Hôpital Sainte Anne, Paris, France.'}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Gaillard', 'Affiliation': 'GHU Paris Psychiatrie et Neurosciences, Hôpital Sainte Anne, Paris, France.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Simon', 'Affiliation': 'CH Le Vinatier, Bron, France.'}, {'ForeName': 'Marie-Françoise', 'Initials': 'MF', 'LastName': 'Suaud-Chagny', 'Affiliation': 'CH Le Vinatier, Bron, France.'}, {'ForeName': 'Filipe', 'Initials': 'F', 'LastName': 'Galvao', 'Affiliation': 'CH Le Vinatier, Bron, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Poulet', 'Affiliation': 'CH Le Vinatier, Bron, France.'}]",Frontiers in pharmacology,['10.3389/fphar.2020.562137']
2238,33041833,"Expression of Concern: The Effects of Vitamin D Supplementation on Signaling Pathway of Inflammation and Oxidative Stress in Diabetic Hemodialysis: A Randomized, Double-Blind, Placebo-Controlled Trial.",,2020,,['Diabetic Hemodialysis'],"['Vitamin D Supplementation', 'Placebo']",[],"[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.387653,,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Frontiers in pharmacology,['10.3389/fphar.2020.602201']
2239,33041861,Cardiorespiratory and Neuromuscular Demand of Daily Centrifugation: Results From the 60-Day AGBRESA Bed Rest Study.,"Purpose


Long stays in space require countermeasures for the degrading effects of weightlessness on the human body, and artificial gravity (AG) has been proposed as an integrated countermeasure. The aim of this study was to assess the cardiorespiratory and neuromuscular demand of AG elicited via daily centrifugation during 60 days of bed rest.
Methods


Twenty four participants (33 ± 9 y, 175 ± 9 cm, 74 ± 10 kg, 8 female) were subjected to 60 days of strict six-degree head-down tilt (HDT) bed rest and were randomly allocated to one of three experimental groups: 30 min of daily centrifugation with an acceleration of 1 g at the center of mass and 2 g at the feet applied continuously (cAG) or intermittently in 6 epochs of 5 min each, separated by 3 min breaks (iAG), or non-centrifuged control (CTRL). Cardiorespiratory demand during centrifugation was assessed at the beginning (HDT3) and end (HDT60) of the bed rest phase via spirometry and heart rate monitoring, leg muscle activation was monitored via electromyography.
Results


On average, analyses of variance revealed that heart rate during centrifugation increased by 40% (iAG) and 60% (cAG) compared to resting values ( p  < 0.001), while oxygen uptake did not change significantly ( p  = 0.96). There was a preference for calf over knee extensor muscle activation (active time soleus 57 ± 27%, gastrocnemius medialis 45 ± 27% and vastus lateralis 27 ± 27%,  p  < 0.001), with large inter-individual differences in leg muscle active time. AG could not prevent the increase in resting heart rate after bed rest. For most of the recorded parameters, there were little differences between cAG and iAG, with the increase in heart rate during centrifugation being a notable exception (greater increase for cAG,  p  = 0.01).
Conclusion


Daily 30 min bouts of artificial gravity elicited by centrifugation put a substantial demand on the heart as a pump without increasing oxygen consumption. If centrifugation is to be used as a countermeasure for the deteriorating effects of microgravity on physical performance, we recommend combining it with strenuous exercise.",2020,"There was a preference for calf over knee extensor muscle activation (active time soleus 57 ± 27%, gastrocnemius medialis 45 ± 27% and vastus lateralis 27 ± 27%,  p  < 0.001), with large inter-individual differences in leg muscle active time.","['Methods\n\n\nTwenty four participants (33 ± 9 y, 175 ± 9 cm, 74 ± 10 kg, 8 female) were subjected to 60 days of strict six-degree head-down tilt (HDT) bed rest']","['AG elicited via daily centrifugation', 'Cardiorespiratory and Neuromuscular Demand of Daily Centrifugation', 'daily centrifugation with an acceleration of 1 g at the center of mass and 2 g at the feet applied continuously (cAG) or intermittently in 6 epochs of 5 min each, separated by 3 min breaks (iAG), or non-centrifuged control (CTRL']","['resting heart rate', 'calf over knee extensor muscle activation', 'oxygen uptake', 'heart rate', 'heart rate during centrifugation', 'leg muscle active time']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242683', 'cui_str': 'Head-Down Tilt'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}]","[{'cui': 'C0242678', 'cui_str': 'Gravity, Artificial'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0179834', 'cui_str': 'Centrifuge'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}, {'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",24.0,0.069975,"There was a preference for calf over knee extensor muscle activation (active time soleus 57 ± 27%, gastrocnemius medialis 45 ± 27% and vastus lateralis 27 ± 27%,  p  < 0.001), with large inter-individual differences in leg muscle active time.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kramer', 'Affiliation': 'Department of Sport Science, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Venegas-Carro', 'Affiliation': 'Department of Sport Science, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Mulder', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center (DLR), Cologne, Germany.'}, {'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Lee', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center (DLR), Cologne, Germany.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Moreno-Villanueva', 'Affiliation': 'Department of Biology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Bürkle', 'Affiliation': 'Department of Biology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gruber', 'Affiliation': 'Department of Sport Science, University of Konstanz, Konstanz, Germany.'}]",Frontiers in physiology,['10.3389/fphys.2020.562377']
2240,33041987,Behavioral and Neural Correlates of Cognitive Training and Transfer Effects in Stroke Patients.,"Stroke lesions are frequently followed by cognitive impairments. Cognitive training is a non-pharmacological intervention that can promote neural compensation mechanisms and strategies to remediate cognitive impairments. The aims of this study were: (1) To investigate the cognitive performance, generalization effects, and neural correlates of semantic organization strategy training (SOST) in patients with chronic left frontoparietal stroke and healthy controls (HC); and (2) to compare the behavioral effects and neural correlates of SOST with an active control psychoeducation intervention (PI). In this randomized controlled study, all participants were randomly allocated into two groups, one group received SOST, and the other received PI intervention. Participants underwent two fMRI sessions, one prior and the other, after intervention. In each fMRI session, images were obtained during memory encoding task using a list of semantically related words. We found improved post-intervention memory performance in participants that received SOST (both patients and controls), indicated by number of words recalled, word clustering scores, and performance in a generalization task. The fMRI analysis revealed negative correlation between task performance and regions of the default-mode network. These results suggest that cognitive training using semantic organization strategy can improve episodic memory performance and promote potential functional neuroplasticity in patients with ischemic stroke lesions.  Clinical Trial Registration:  www.ClinicalTrials.gov, identifier: NCT03644290.",2020,"We found improved post-intervention memory performance in participants that received SOST (both patients and controls), indicated by number of words recalled, word clustering scores, and performance in a generalization task.","['patients with ischemic stroke lesions', 'Stroke Patients', 'patients with chronic left frontoparietal stroke and healthy controls (HC']","['Cognitive training', 'SOST with an active control psychoeducation intervention (PI', 'semantic organization strategy training (SOST', 'PI intervention', 'cognitive training using semantic organization strategy', 'SOST']",['episodic memory performance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0589105', 'cui_str': 'Strategy training'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0561843', 'cui_str': 'Episodic memory'}]",,0.0741126,"We found improved post-intervention memory performance in participants that received SOST (both patients and controls), indicated by number of words recalled, word clustering scores, and performance in a generalization task.","[{'ForeName': 'Eliane C', 'Initials': 'EC', 'LastName': 'Miotto', 'Affiliation': 'Department of Neurology, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Paulo R', 'Initials': 'PR', 'LastName': 'Bazán', 'Affiliation': 'Institute of Radiology, LIM-44, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alana X', 'Initials': 'AX', 'LastName': 'Batista', 'Affiliation': 'Department of Neurology, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Adriana B', 'Initials': 'AB', 'LastName': 'Conforto', 'Affiliation': 'Department of Neurology, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Eberval G', 'Initials': 'EG', 'LastName': 'Figueiredo', 'Affiliation': 'Department of Neurology, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria da Graça M', 'Initials': 'MDGM', 'LastName': 'Martin', 'Affiliation': 'Institute of Radiology, LIM-44, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Isabella B', 'Initials': 'IB', 'LastName': 'Avolio', 'Affiliation': 'Department of Neurology, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Amaro', 'Affiliation': 'Institute of Radiology, LIM-44, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Manoel J', 'Initials': 'MJ', 'LastName': 'Teixeira', 'Affiliation': 'Department of Neurology, University of São Paulo, São Paulo, Brazil.'}]",Frontiers in neurology,['10.3389/fneur.2020.01048']
2241,31829793,Cognitive short- and long-term effects of coffee cherry extract in older adults with mild cognitive decline.,"There has been increasing interest in food- and dietary supplement-based materials that may support healthy cognition. However, few studies have quantitatively measured bioavailability, bioactivity, or cognitive short- and long-term effects of these materials against placebo. Earlier clinical studies reported ability of coffee cherry extract (CCE) to a.) reduce levels of reactive oxygen species (ROS) in human blood and b.) to increase serum and exosomal levels of brain-derived neurotrophic factor (BDNF), a neuroprotein essential for neurogenesis. Here, we examined CCE influence on cognitive performance. Seventy-one adults with mild cognitive decline completed this double blind, randomized, placebo-controlled, 28-day regimen. Participants engaged in a cognitive challenge that involved working memory processes. Our results suggest that effects of CCE were notable during the first week and persisted throughout the study period. Specifically, participants on the CCE regimens had significant reductions in reaction time compared to placebo when comparing baseline to days 7 and 28 ( p  = 0.040, partial  η 2   = 0.130). A main effect of group was not identified for accuracy; however, strong trends were noted between the placebo group and two of the three CCE groups. These results suggest CCE, when taken in the morning or twice per day, is associated with improvements in reaction times and trends toward indications of improved accuracy. Although further research is required, these observations may be indicative of underlying processes such as increased processing speed, sustained attention, and/or focus.",2020,"Specifically, participants on the CCE regimens had significant reductions in reaction time compared to placebo when comparing baseline to days 7 and 28 ( p  = 0.040, partial  η 2   = 0.130).","['older adults with mild cognitive decline', 'Seventy-one adults with mild cognitive decline']","['coffee cherry extract', 'placebo', 'CCE']","['bioavailability, bioactivity, or cognitive short', 'cognitive performance', 'reaction time', 'reaction times and trends toward indications of improved accuracy']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0330657', 'cui_str': 'Prunus cerasus'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",71.0,0.247002,"Specifically, participants on the CCE regimens had significant reductions in reaction time compared to placebo when comparing baseline to days 7 and 28 ( p  = 0.040, partial  η 2   = 0.130).","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Robinson', 'Affiliation': 'Department of Psychology, Auburn University , Auburn, AL, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Hunter', 'Affiliation': 'VDF FutureCeuticals, Inc ., Momence, IL, USA.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Reyes-Izquierdo', 'Affiliation': 'VDF FutureCeuticals, Inc ., Irvine, CA, USA.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Argumedo', 'Affiliation': 'VDF FutureCeuticals, Inc ., Irvine, CA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Brizuela-Bastien', 'Affiliation': 'Centro Cognitivo Conductual , Tijuana, Mexico.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Keller', 'Affiliation': 'NutraClinical, Inc ., San Diego, CA, USA.'}, {'ForeName': 'Zbigniew J', 'Initials': 'ZJ', 'LastName': 'Pietrzkowski', 'Affiliation': 'VDF FutureCeuticals, Inc ., Irvine, CA, USA.'}]","Neuropsychology, development, and cognition. Section B, Aging, neuropsychology and cognition",['10.1080/13825585.2019.1702622']
2242,33048342,The effect of remote ischaemic preconditioning on endothelial function after hip fracture surgery.,"BACKGROUND


Endothelial dysfunction seems to play a role in the pathophysiology of myocardial injury after surgery. The aim of this randomised clinical trial was to examine whether remote ischaemic preconditioning in relation to hip fracture surgery ameliorates postoperative systemic endothelial dysfunction.
METHODS


This was a planned single centre pilot sub-study of a multicentre, randomised clinical trial. Patients ≥ 45 years with a cardiovascular risk factor were randomised to remote ischaemic preconditioning (RIPC) or control (standard treatment) performed in relation to their hip fracture operation. RIPC consisted of four cycles of five minutes forearm ischaemia and reperfusion. The procedure was performed non-invasively with a tourniquet. The endothelial function was assessed with non-invasive digital pulse amplitude tonometry on postoperative day 1 and expressed as the reactive hyperaemia index (RHI). Endothelial dysfunction was defined as RHI < 1.22.
RESULTS


Between February 2015 and December 2016, 18 patients were allocated to the RIPC group and 20 patients to the control group. The endothelial function was impaired in both groups on postoperative day 1. RHI did not differ between the groups, 1.47 (95% CI 1.20-1.75) in the RIPC group vs. 1.54 (95% CI 1.17-1.91) in the control group, p=0.76. Endothelial dysfunction was present in 3/18 patients (16.7%) in the RIPC group and in 8/20 patients (40%) in the control group, p=0.11.
CONCLUSION


No beneficial effect of remote ischaemic preconditioning on the systemic endothelial dysfunction, assessed at a single time point on postoperative day one, was detected after hip fracture surgery.",2020,"RHI did not differ between the groups, 1.47 (95% CI 1.20-1.75) in the RIPC group vs. 1.54 (95% CI 1.17-1.91) in the control group, p=0.76.","['Patients ≥ 45 years with a cardiovascular risk factor', 'Between February 2015 and December 2016', 'after hip fracture surgery', '18 patients were allocated to the RIPC group and 20 patients to the control group']","['remote ischaemic preconditioning', 'remote ischaemic preconditioning (RIPC) or control (standard treatment) performed in relation to their hip fracture operation']","['Endothelial dysfunction', 'systemic endothelial dysfunction', 'reactive hyperaemia index (RHI', 'RHI', 'endothelial function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",18.0,0.0816998,"RHI did not differ between the groups, 1.47 (95% CI 1.20-1.75) in the RIPC group vs. 1.54 (95% CI 1.17-1.91) in the control group, p=0.76.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ekeloef', 'Affiliation': 'Center for Surgical Science, Department of Surgery, Zealand University Hospital, Lykkebaekvej1, DK-4600, Koege, Denmark.'}, {'ForeName': 'Ossian', 'Initials': 'O', 'LastName': 'Gundel', 'Affiliation': 'Center for Surgical Science, Department of Surgery, Zealand University Hospital, Lykkebaekvej1, DK-4600, Koege, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Falkenberg', 'Affiliation': 'Center for Surgical Science, Department of Surgery, Zealand University Hospital, Lykkebaekvej1, DK-4600, Koege, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Mathiesen', 'Affiliation': 'Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital, Lykkebaekvej 1, DK-4600, Koege, Denmark.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Gögenur', 'Affiliation': 'Center for Surgical Science, Department of Surgery, Zealand University Hospital, Lykkebaekvej1, DK-4600, Koege, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13724']
2243,33048394,Number of screening rounds attended and incidence of high-risk prostate cancer in the Finnish Randomized Study of Screening for Prostate Cancer (FinRSPC).,"BACKGROUND


The European Randomized Study of Screening for Prostate Cancer has shown a 20% reduction in prostate cancer (PC) mortality by prostate-specific antigen-based screening. In addition, screening has been shown to reduce the risk of advanced PC. The objective of the current study was to analyze the impact of screening participation on the incidence of PC by risk group.
METHODS


The participants in the screening arm of the Finnish trial (31,867 men) were classified according to screening attendance in a time-dependent fashion. Initially, all men in the screening arm were regarded as nonattenders until the first screening attendance; they then remained in the once-screened group until the second screen and similarly for the possible third round. The control arm formed the reference group. Follow-up started at randomization and ended at the time of diagnosis of PC, emigration, or the end of 2015. PC cases were divided into risk groups according to European Association of Urology definitions.
RESULTS


The incidence of low-risk PC increased with the number of screens, whereas no clear relation with participation was noted in the intermediate-risk and high-risk cases. For patients with advanced PC, attending screening at least twice was associated with a lower risk.
CONCLUSIONS


Screening reduces the risk of advanced PC after only 2 screening cycles. A single screen demonstrated no benefit in terms of PC incidence. Repeated screening is necessary to achieve screening advantages.",2020,"The incidence of low-risk PC increased with the number of screens, whereas no clear relation with participation was noted in the intermediate-risk and high-risk cases.","['participants in the screening arm of the Finnish trial (31,867 men) were classified according to screening attendance in a time-dependent fashion']",[],"['risk of advanced PC', 'incidence of low-risk PC']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]",31867.0,0.0604018,"The incidence of low-risk PC increased with the number of screens, whereas no clear relation with participation was noted in the intermediate-risk and high-risk cases.","[{'ForeName': 'Tomi', 'Initials': 'T', 'LastName': 'Pakarainen', 'Affiliation': 'Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Jaakko', 'Initials': 'J', 'LastName': 'Nevalainen', 'Affiliation': 'Unit of Health Sciences, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Talala', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, University of Helsinki, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jani', 'Initials': 'J', 'LastName': 'Raitanen', 'Affiliation': 'Unit of Health Sciences, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Kujala', 'Affiliation': 'Department of Pathology, FimLab Laboratories, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Ulf-Håkan', 'Initials': 'UH', 'LastName': 'Stenman', 'Affiliation': 'Department of Clinical Chemistry, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Teuvo L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'Unit of Health Sciences, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}]",Cancer,['10.1002/cncr.33254']
2244,33048421,"Tasmannia lanceolata leaf extract alleviates stretch mark appearance in a randomized, placebo-controlled clinical trial in women and stimulates extracellular matrix synthesis in ex vivo human skin explants.","OBJECTIVE


The leaves of Tasmannia lanceolata mainly contain polygodial that is known to exhibit a range of biological functions including anti-inflammatory effects. These studies aimed to assess the effects of Tasmannia lanceolata extract (TLE) on skin and more particularly, on stretch marks in women.
METHODS


A double blind, randomized, placebo-controlled clinical study was carried out on 29 women, aged from 25 to 60 years, to investigate the effects of TLE on stabilized stretch marks. TLE and placebo products were topically applied daily for 8 weeks. Skin roughness and firmness of stretch marks were assessed by 2D and 3D photograph processing and analyses. Dermal density and thickness were evaluated using ultrasound, while stretch mark conditions (length, color, depth) were determined by clinical scoring. Matricial proteins (pro-collagen I and elastin) and pro-matricial factors, like TGFβ concentrations, were quantified from cultures of human skin explants presenting stretch marks, treated with TLE or vehicle control.
RESULTS


Skin roughness of stretch marks was significantly reduced in the TLE group after 8 weeks of treatment. Skin firmness of stretch marks was significantly increased in the TLE group after 4 weeks of treatment and this improved effect was maintained until the end of the study. Dermal density and thickness were significantly increased in the TLE group compared to the placebo group. Furthermore, TLE restored the dermal condition of the stretch mark skin, up to normal skin levels. In addition, pro-collagen I and elastin concentrations were found to be higher in the TLE-treated stretch mark skin explants compared to the untreated ones, associated with higher quantities of TGFβ production.
CONCLUSION


These results revealed that TLE could help improve the aspect of stabilized stretch marks in women by restoring the matricial environment.",2020,Skin firmness of stretch marks was significantly increased in the TLE group after 4 weeks of treatment and this improved effect was maintained until the end of the study.,"['women', '29 women, aged from 25 to 60 years']","['TLE or vehicle control', 'TLE and placebo', 'placebo', 'TLE', 'Tasmannia lanceolata extract (TLE']","['Skin firmness of stretch marks', 'elastin concentrations', 'Skin roughness of stretch marks', 'Dermal density and thickness', 'Skin roughness and firmness of stretch marks']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0152459', 'cui_str': 'Linear atrophy'}, {'cui': 'C0013765', 'cui_str': 'Elastin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",29.0,0.063414,Skin firmness of stretch marks was significantly increased in the TLE group after 4 weeks of treatment and this improved effect was maintained until the end of the study.,"[{'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Gaillard', 'Affiliation': 'Robertet Group, Grasse, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Boisnic', 'Affiliation': 'Gredeco, Paris, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Branchet', 'Affiliation': 'Gredeco, Paris, France.'}, {'ForeName': 'Irène', 'Initials': 'I', 'LastName': 'Lamour', 'Affiliation': 'Robertet Group, Grasse, France.'}, {'ForeName': 'Mayoura', 'Initials': 'M', 'LastName': 'Keophiphath', 'Affiliation': 'D.I.V.A. Expertise, Toulouse, France.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13780']
2245,33048462,Comparison of nonself-tapping tapered implant and self-tapping hybrid implant in terms of implant stability at initial and second fixation: A prospective randomized clinical trial.,"BACKGROUND


Various features are provided in dental implants to improve initial fixation.
PURPOSE


To compare the implant stability of the nonself-tapping tapered implant and self-tapping hybrid implant over a 3-month healing period.
MATERIALS AND METHODS


A randomized controlled trial was conducted. Patients were randomly divided into tapered and self-tapping groups. Patients in the tapered group received NobelReplace Tapered (Nobel Biocare, Sweden) implants, while those in the self-tapping group received NobelSpeedy (Nobel Biocare, Sweden) implants. Implant stability was measured by resonance frequency analysis at surgery and 3 months following implant insertion. Data were analyzed using an independent t-test.
RESULTS


Forty-three patients (tapered group: 21, self-tapping group: 22) received a total of 88 implants. Initial stability in the tapered group was significantly higher (mean: 60.14, SD: 12.40) than that in the self-tapping group (mean: 54.72, SD: 7.92). Implant stability significantly increased 3 months after implantation in the tapered group (mean: 66.61, SD: 9.00) and self-tapping group (mean: 64.01, SD: 5.78). No significant intergroup difference in implant stability was noted 3 months after surgery.
CONCLUSIONS


The tapered shape affected initial fixation more than the self-tapping function. However, during the second fixation, both implants showed good stability, and the difference disappeared.",2020,"Initial stability in the tapered group was significantly higher (mean: 60.14, SD: 12.40) than that in the self-tapping group (mean: 54.72, SD: 7.92).","['Forty-three patients (tapered group: 21, self-tapping group: 22) received a total of 88 implants']","['nonself-tapping tapered implant and self-tapping hybrid implant', 'NobelReplace Tapered (Nobel Biocare, Sweden) implants, while those in the self-tapping group received NobelSpeedy (Nobel Biocare, Sweden) implants']","['implant stability', 'Implant stability', 'Initial stability']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",,0.0467038,"Initial stability in the tapered group was significantly higher (mean: 60.14, SD: 12.40) than that in the self-tapping group (mean: 54.72, SD: 7.92).","[{'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Moroi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Division of Clinical Medicine, Graduated Faculty of Interdisciplinary, University of Yamanashi, Yamanashi, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Division of Clinical Medicine, Graduated Faculty of Interdisciplinary, University of Yamanashi, Yamanashi, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Takayama', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Division of Clinical Medicine, Graduated Faculty of Interdisciplinary, University of Yamanashi, Yamanashi, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Ueki', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Division of Clinical Medicine, Graduated Faculty of Interdisciplinary, University of Yamanashi, Yamanashi, Japan.'}]",Clinical implant dentistry and related research,['10.1111/cid.12951']
2246,33048477,Impact of green tea catechin ingestion on the pharmacokinetics of lisinopril in healthy volunteers.,"Lisinopril, a highly hydrophilic long-acting ACE inhibitor, is frequently prescribed for the treatment of hypertension and congestive heart failure. Green tea consumption may reduce the risk of cardiovascular outcomes and total mortality, whereas green tea or its catechin components has been reported to decrease plasma concentrations of a hydrophilic β blocker, nadolol, in humans. The aim of this study was to evaluate possible effects of green tea extract (GTE) on the lisinopril pharmacokinetics. In an open-label, randomized, single-center 2-phase crossover study, 10 healthy subjects ingested 200 ml of an aqueous solution of GTE containing approximately 300 mg of (-)-epigallocatechin gallate (EGCG), a major catechin component in green tea, or water (control) when receiving 10 mg of lisinopril after overnight fasting. The geometric mean ratio (GTE/control) for maximum plasma concentration and the area under the plasma concentration-time curve of lisinopril were 0.289 (90% confidence interval [CI], 0.226-0.352) and 0.337 (90% CI, 0.269-0.405), respectively. In contrast, there were no significant differences in time to reach maximum lisinopril concentration (6 hours in both phases) and renal clearance of lisinopril (57.7 ml/min in control vs. 56.9 ml/min in GTE). These results suggest that the extent of intestinal absorption of lisinopril was significantly impaired in the presence of GTE, while it had no major effect on the absorption rate and renal excretion of lisinopril. Concomitant use of lisinopril and green tea may decrease oral exposure to lisinopril, and therefore result in reduced therapeutic efficacy.",2020,The geometric mean ratio (GTE/control) for maximum plasma concentration and the area under the plasma concentration-time curve of lisinopril were 0.289,"['10 healthy subjects', 'healthy volunteers']","['lisinopril', 'green tea extract (GTE', 'lisinopril and green tea', 'Lisinopril', 'green tea catechin ingestion', 'ingested 200 ml of an aqueous solution of GTE containing approximately 300 mg of (-)-epigallocatechin gallate (EGCG), a major catechin component in green tea, or water (control) when receiving 10 mg of lisinopril']","['risk of cardiovascular outcomes and total mortality', 'time to reach maximum lisinopril concentration', 'geometric mean ratio (GTE/control) for maximum plasma concentration and the area under the plasma concentration-time curve of lisinopril', 'renal clearance', 'absorption rate and renal excretion of lisinopril', 'intestinal absorption of lisinopril']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0007404', 'cui_str': 'Catechin'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C1373187', 'cui_str': 'Renal Excretion'}, {'cui': 'C0021826', 'cui_str': 'Intestinal absorption'}]",10.0,0.054676,The geometric mean ratio (GTE/control) for maximum plasma concentration and the area under the plasma concentration-time curve of lisinopril were 0.289,"[{'ForeName': 'Shingen', 'Initials': 'S', 'LastName': 'Misaka', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Ono', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Uchida', 'Affiliation': 'Department of Pharmacy, University of Yamanashi Hospital, Chuo-city, Yamanashi, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Ono', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Abe', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogata', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Sato', 'Affiliation': 'Laboratory of Biopharmacy, School of Pharmaceutical Sciences, University of Shizuoka, Suruga-ku, Shizuoka, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Pharmacy, University of Yamanashi Hospital, Chuo-city, Yamanashi, Japan.'}, {'ForeName': 'Satomi', 'Initials': 'S', 'LastName': 'Onoue', 'Affiliation': 'Laboratory of Biopharmacy, School of Pharmaceutical Sciences, University of Shizuoka, Suruga-ku, Shizuoka, Japan.'}, {'ForeName': 'Yayoi', 'Initials': 'Y', 'LastName': 'Shikama', 'Affiliation': 'Center for Medical Education and Career Development, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Kenju', 'Initials': 'K', 'LastName': 'Shimomura', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}]",Clinical and translational science,['10.1111/cts.12905']
2247,33044886,Effects of plyometric exercises on muscle-activation strategies and response-capacity to balance threats in children with hemiplegic cerebral palsy.,"OBJECTIVE


Children with hemiplegic cerebral palsy (hCP) experience a disorganized muscle activation pattern that adversely affect their ability to respond to balance perturbations. This study examined the effect of plyometric exercises on muscle-activation strategies and response-capacity to balance threats in children with hCP.
METHODS


In a pre-, posttest control-group study, 34 children with hCP were allocated randomly to either the control group ( n  = 17; received a traditional physical rehabilitation program, lasted for 45 minutes/session, twice/week for three successive months) or the plyometric group ( n  = 17; received a progressive plyometric training program in three blocks, twice/week over three months plus the traditional physical rehabilitation). Quadriceps/hamstring co-contraction ratio (Q/H Co-CR) and response-capacity to balance threats were assessed pre- and post-treatment.
RESULTS


Post-treatment, the Q/H Co-CR and balance control improved significantly in the control ( P  = .03,  P  = .0003 respectively) and plyomteric group ( P  = .001,  P  ˂ 0.001 respectively). However, the plyometric group showed better improvements in Q/H Co-CR ( P  = .0001) and balance control ( P  = .027) when compared to the control group.
CONCLUSION


Incorporation of plyometric exercises into traditional physical rehabilitation could improve muscle-activation strategies and enhance balance control in children with hCP.",2020,"However, the plyometric group showed better improvements in Q/H Co-CR ( P  = .0001) and balance control ( P  = .027) when compared to the control group.
","['children with hemiplegic cerebral palsy', '34 children with hCP', 'children with hCP', 'Children with hemiplegic cerebral palsy (hCP']","['traditional physical rehabilitation program', 'plyometric exercises', 'plyometric group ( n  =\xa017; received a progressive plyometric training program in three blocks, twice/week over three months plus the traditional physical rehabilitation']","['balance control', 'Q/H Co-CR', 'Quadriceps/hamstring co-contraction ratio (Q/H Co-CR) and response-capacity to balance threats', 'Q/H Co-CR and balance control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",34.0,0.013287,"However, the plyometric group showed better improvements in Q/H Co-CR ( P  = .0001) and balance control ( P  = .027) when compared to the control group.
","[{'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University , Al-Kharj, Saudi Arabia.'}]",Physiotherapy theory and practice,['10.1080/09593985.2020.1833389']
2248,33044990,Experiences of tobacco cessation including a prescription approach among patients in Swedish primary health care with a focus on socioeconomically disadvantaged areas.,"BACKGROUND


Tobacco Cessation on Prescription (TCP) is a new intervention that is being evaluated in socioeconomically disadvantaged areas in Swedish primary health care (PHC). Patients' perceptions of TCP are important to understand as this may have implications for the acceptability and adherence to treatment and explain cessation outcomes. Patients' general experiences of tobacco cessation are also important to explore to improve cessation support in this setting.
AIM


To explore experiences of tobacco cessation and TCP among patients in Swedish PHC focusing on socioeconomically disadvantaged areas.
METHODS


Inductive content analysis of transcripts from eight semi-structured interviews with patients recruited from the intervention group in a randomized controlled trial evaluating the effectiveness of TCP in socioeconomically disadvantaged areas in PHC in Stockholm.
RESULTS


Two themes were identified: needing individualized support to quit, taking differences in patients' experiences of tobacco use and cessation into account, acknowledging individual factors such as impact of health and wellbeing on tobacco use and differing attitudes towards tobacco and cessation and needing a supportive environment to facilitate tobacco cessation, taking contextual factors like professional support from the health care system, the importance of the social environment and supportive societal structures into account. Regarding TCP, the prescription form was perceived as useful for providers but did not appear to have a direct impact on tobacco cessation from the informants' perspective. However, individualized counseling from a tobacco cessation specialist, an empathetic approach in the treatment and long-term follow-up was considered important.
CONCLUSION


A holistic approach may be needed in cessation treatment, combined with interventions outside the health care system, to facilitate tobacco cessation among patients in socioeconomically disadvantaged areas in Swedish PHC. The TCP prescription form may be helpful for PHC providers but counseling and follow-up appear to be the most important components of TCP for patients in this setting.",2020,"Regarding TCP, the prescription form was perceived as useful for providers but did not appear to have a direct impact on tobacco cessation from the informants' perspective.","['Inductive content analysis of transcripts from eight semi-structured interviews with patients recruited from the intervention group', 'patients in Swedish PHC focusing on socioeconomically disadvantaged areas', 'socioeconomically disadvantaged areas in PHC in Stockholm', 'patients in Swedish primary health care with a focus on socioeconomically disadvantaged areas', ""Patients' general experiences of tobacco cessation"", 'socioeconomically disadvantaged areas in Swedish primary health care (PHC', 'patients in socioeconomically disadvantaged areas in Swedish PHC']","['TCP', 'Tobacco Cessation on Prescription (TCP', 'tobacco cessation and TCP', 'tobacco cessation']",[],"[{'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}]","[{'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]",[],2.0,0.038746,"Regarding TCP, the prescription form was perceived as useful for providers but did not appear to have a direct impact on tobacco cessation from the informants' perspective.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Leppänen', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Solvig', 'Initials': 'S', 'LastName': 'Ekblad', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Tomson', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden.'}]",PloS one,['10.1371/journal.pone.0240411']
2249,33045085,The cigarette smoking initiation and continuation in adolescents undergoing a long-term behavioral intervention.,"INTRODUCTION


Targeting adolescents' smoking reduces its burden on health systems. We investigated the effects of the first multidisciplinary community-based lifestyle intervention in the Eastern-Mediterranean region, on smoking initiation, continuation and risk of current smoking in Iranian adolescents.
METHODS


The current analyses were conducted on 945 non-smoker adolescents (12-18 years) who participated in Phase II of Tehran Lipid and Glucose Study (TLGS) and were examined four times in 12 years. The lifestyle intervention including school-based and public programs was implemented, focusing on all components of healthy lifestyle. Using two-step cluster analysis families were classified as high- and low-risk, based on parental risk factors of adolescents' smoking. Participants who failed to complete all the follow-ups (n=99) and those with missing smoking data were excluded. Subsequently, 872 adolescents (538 control, 334 intervention) were included in the Cox model on smoking initiation and 674 adolescents (414 control, 260 intervention) were included in the logistic regression on smoking status.
RESULTS


Mean age of adolescents was 15.08±1.94 years at baseline. The hazard of the smoking initiation was significantly lower in the intervention (HR=0.71, 95% CI: 0.51-0.99; P=0.044) compared to control group. At the end of the 4 th follow-up, intervention reduced the odds of current cigarette smoking by 29%. Within the intervention group, the high-risk cluster was at a 35% lower risk of initiating smoking and had 37% lower odds of becoming a current smoker. However, the intervention could not make a difference in preventing those who initiated smoking from maintaining it during the follow-ups.
CONCLUSIONS


Our results demonstrate that lifestyle modification programs targeting at-risk populations could reduce risk of smoking initiation and current smoking in adolescents in long-term.
IMPLICATIONS


Experiencing cigarette smoking at the critical period of adolescence could result in adulthood habitual smoking. Therefore, identifying adolescents who are more at risk of smoking initiation and implementing targeted interventions are of great importance in public health. Our findings highlight the long-term effectiveness of a multidisciplinary community-based behavioral intervention on forming smoking behaviors in adolescents. The current intervention was successful in reducing smoking uptake in adolescents living in high-risk families.",2020,"The hazard of the smoking initiation was significantly lower in the intervention (HR=0.71, 95% CI: 0.51-0.99; P=0.044) compared to control group.","['Iranian adolescents', 'Participants who failed to complete all the follow-ups (n=99) and those with missing smoking data were excluded', 'adolescents undergoing a long-term behavioral intervention', '945 non-smoker adolescents (12-18 years) who participated in Phase II of Tehran Lipid and Glucose Study (TLGS) and were examined four times in 12 years', '872 adolescents (538 control, 334 intervention) were included in the Cox model on smoking initiation and 674 adolescents (414 control, 260 intervention', 'adolescents', 'adolescents living in high-risk families']","['multidisciplinary community-based lifestyle intervention', 'multidisciplinary community-based behavioral intervention']","['odds of current cigarette smoking', 'smoking uptake', 'hazard of the smoking initiation', 'risk of smoking initiation and current smoking']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010234', 'cui_str': 'Cox Models'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C4517771', 'cui_str': '414'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",945.0,0.0157767,"The hazard of the smoking initiation was significantly lower in the intervention (HR=0.71, 95% CI: 0.51-0.99; P=0.044) compared to control group.","[{'ForeName': 'Hasti', 'Initials': 'H', 'LastName': 'Masihay-Akbar', 'Affiliation': 'Research Center for Social Determinants of Health, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Amiri', 'Affiliation': 'Research Center for Social Determinants of Health, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Cheraghi', 'Affiliation': 'Department of Biostatistics and Epidemiology, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Abbas', 'Initials': 'AA', 'LastName': 'Momenan', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereidoun', 'Initials': 'F', 'LastName': 'Azizi', 'Affiliation': 'Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa208']
2250,33045126,The effect of Mulligan's mobilization with movement following total knee arthroplasty: Protocol of a single-blind randomized controlled trial.,"BACKGROUND


Mulligan's mobilization with movement (MWM) aims to enhance the kinematics of the joint. Kinematic impairment of the knee joint is significant following total knee arthroplasty (TKA), which could be managed with Mulligan's MWM. This article describes the study protocol for a single-blind randomized controlled trial investigating the effectiveness of Mulligan's MWM following TKA.
METHODS


A single-blind randomized controlled trial design will be employed to compare two groups: an intervention and control group. Each group will attend a standard post-operative rehabilitation program. The intervention group will additionally receive articular mobilization using a Mulligan's MWM approach. A blinded examiner will assess participants at four points: pre-operation, 3 weeks post-operation (when the intervention starts), 6 weeks post-operation (when the intervention ends), and at 6 months as a long-term follow-up. The two groups will be compared on the basis of knee range of motion (standard goniometry), knee joint pain (Visual Analogue Scales), walking speed using (15-metre walk test), functional mobility (timed up and go test) and participation (Western Ontario and McMaster Universities Osteoarthritis Index questionnaire). A blinded examiner will measure knee joint alignment using a computed tomography scanogram pre-operatively and at 3 months post operation. Mixed model ANOVA will be used to identify any group differences. Ethical approval has been secured from the ethical committee of Kuwait Ministry of Health, and the trial is registered in the ISRCTN registry (ref:13028992).
DISCUSSION


The study findings could inform the optimization of post-operative rehabilitation of patients following TKA.",2020,"Kinematic impairment of the knee joint is significant following total knee arthroplasty (TKA), which could be managed with Mulligan's MWM.","['total knee arthroplasty (TKA', 'total knee arthroplasty']","[""Mulligan's mobilization"", ""articular mobilization using a Mulligan's MWM approach"", ""Mulligan's MWM""]","['knee joint pain (Visual Analogue Scales), walking speed using (15-metre walk test), functional mobility (timed up and go test) and participation (Western Ontario and McMaster Universities Osteoarthritis Index questionnaire']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0475209', 'cui_str': 'meter'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.156608,"Kinematic impairment of the knee joint is significant following total knee arthroplasty (TKA), which could be managed with Mulligan's MWM.","[{'ForeName': 'Najla F', 'Initials': 'NF', 'LastName': 'Alsiri', 'Affiliation': 'Rehabilitation Department, Al-Razi Orthopaedics and Rehabilitation Hospital, Shuwaikh, Kuwait.'}, {'ForeName': 'Meshal A', 'Initials': 'MA', 'LastName': 'Alhadhoud', 'Affiliation': 'Orthopaedics Department, Al-Adan Hospital, Hadiya, Kuwait.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al-Mukaimi', 'Affiliation': 'Rehabilitation Department, Al-Razi Orthopaedics and Rehabilitation Hospital, Shuwaikh, Kuwait.'}, {'ForeName': 'Shea', 'Initials': 'S', 'LastName': 'Palmer', 'Affiliation': 'Department of Allied Health Professions, Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}]",Musculoskeletal care,['10.1002/msc.1503']
2251,33045224,A randomized clinical trial to evaluate the efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valve and atrial fibrillation or flutter: Rationale and design of the RIVER trial.,"BACKGROUND


The efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valves and atrial fibrillation or flutter remain uncertain.
DESIGN


RIVER was an academic-led, multicenter, open-label, randomized, non-inferiority trial with blinded outcome adjudication that enrolled 1005 patients from 49 sites in Brazil. Patients with a bioprosthetic mitral valve and atrial fibrillation or flutter were randomly assigned (1:1) to rivaroxaban 20mg once daily (15mg in those with creatinine clearance <50mL/min) or dose-adjusted warfarin (target international normalized ratio 2.0-30.); the follow-up period was 12months. The primary outcome was a composite of all-cause mortality, stroke, transient ischemic attack, major bleeding, valve thrombosis, systemic embolism, or hospitalization for heart failure. Secondary outcomes included individual components of the primary composite outcome, bleeding events, and venous thromboembolism.
SUMMARY


RIVER represents the largest trial specifically designed to assess the efficacy and safety of a direct oral anticoagulant in patients with bioprosthetic mitral valves and atrial fibrillation or flutter. The results of this trial can inform clinical practice and international guidelines.",2020,"The primary outcome was a composite of all-cause mortality, stroke, transient ischemic attack, major bleeding, valve thrombosis, systemic embolism, or hospitalization for heart failure.","['patients with bioprosthetic mitral valves and atrial fibrillation or flutter', 'patients with bioprosthetic mitral valve and atrial fibrillation or flutter', 'Patients with a bioprosthetic mitral valve and atrial fibrillation or flutter', 'enrolled 1005 patients from 49 sites in Brazil', 'patients with bioprosthetic mitral valves and atrial fibrillation or flutter remain uncertain']","['rivaroxaban 20mg once daily (15mg in those with creatinine clearance <50mL/min) or dose-adjusted warfarin', 'rivaroxaban']","['efficacy and safety', 'individual components of the primary composite outcome, bleeding events, and venous thromboembolism', 'composite of all-cause mortality, stroke, transient ischemic attack, major bleeding, valve thrombosis, systemic embolism, or hospitalization for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}]","[{'cui': 'C3248003', 'cui_str': 'rivaroxaban 20 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",1005.0,0.16174,"The primary outcome was a composite of all-cause mortality, stroke, transient ischemic attack, major bleeding, valve thrombosis, systemic embolism, or hospitalization for heart failure.","[{'ForeName': 'Helio P', 'Initials': 'HP', 'LastName': 'Guimarães', 'Affiliation': 'Research Institute - Heart Hospital (HCor) -, São Paulo, Brazil; Hospital Israelita Albert Einstein, São Paulo-SP, Brazil. Electronic address: heliopg@yahoo.com.br.'}, {'ForeName': 'Pedro G M', 'Initials': 'PGM', 'LastName': 'de Barros E Silva', 'Affiliation': 'Research Institute - Heart Hospital (HCor) -, São Paulo, Brazil.'}, {'ForeName': 'Idelzuita L', 'Initials': 'IL', 'LastName': 'Liporace', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia -, São Paulo, Brazil.'}, {'ForeName': 'Roney O', 'Initials': 'RO', 'LastName': 'Sampaio', 'Affiliation': 'Incor - Instituto do Coração do HCFMUSP-, São Paulo, Brazil.'}, {'ForeName': 'Flávio', 'Initials': 'F', 'LastName': 'Tarasoutchi', 'Affiliation': 'Incor - Instituto do Coração do HCFMUSP-, São Paulo, Brazil.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Paixão', 'Affiliation': 'Incor - Instituto do Coração do HCFMUSP-, São Paulo, Brazil.'}, {'ForeName': 'Conrado R', 'Initials': 'CR', 'LastName': 'Hoffmann-Filho', 'Affiliation': 'Hospital Regional Hans Dieter Schmidt - Joinvile, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Patriota', 'Affiliation': 'Hospital Metropolitano Sul Dom Helder Câmara -, Cabo de Santo Agostinho, Brazil.'}, {'ForeName': 'Tiago L L', 'Initials': 'TLL', 'LastName': 'Leiria', 'Affiliation': 'Instituto de Cardiologia do Rio Grande do Sul (FUC) -, Porto Alegre, Brazil.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Lamprea', 'Affiliation': 'Procape -, Recife, Brazil.'}, {'ForeName': 'Dalton B', 'Initials': 'DB', 'LastName': 'Precoma', 'Affiliation': 'Sociedade Hospitalar Angelina Caron -, Campina Grande do Sul, Brazil.'}, {'ForeName': 'Fernando A', 'Initials': 'FA', 'LastName': 'Atik', 'Affiliation': 'Instituto de Cardiologia do Distrito Federal -, Brasília, Brazil.'}, {'ForeName': 'Fabio S', 'Initials': 'FS', 'LastName': 'Silveira', 'Affiliation': 'Clínica do Coração Sergipe - Aracajú, Brazil.'}, {'ForeName': 'Fabio R', 'Initials': 'FR', 'LastName': 'Farias', 'Affiliation': 'Quanta Diagnóstico e Terapia -, Curitiba, Brazil.'}, {'ForeName': 'Diogo O', 'Initials': 'DO', 'LastName': 'Barreto', 'Affiliation': 'Hospital Evangélico de Vila Velha -, Vila Velha, Brazil.'}, {'ForeName': 'Adail P', 'Initials': 'AP', 'LastName': 'Almeida', 'Affiliation': 'Unidade Médico Cirúrgica - Unimec -, Vitória da Conquista, Brazil.'}, {'ForeName': 'Alexandre C', 'Initials': 'AC', 'LastName': 'Zilli', 'Affiliation': 'Hospital de Caridade São Vicente de Paulo -, Jundiaí, Brazil.'}, {'ForeName': 'João D', 'Initials': 'JD', 'LastName': 'de Souza Neto', 'Affiliation': 'Hospital Messejana -, Ceará, Brazil.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Cavalcante', 'Affiliation': 'Hospital Regional de Presidente Prudente -, Presidente Prudente, Brazil.'}, {'ForeName': 'Fernando A M S', 'Initials': 'FAMS', 'LastName': 'Figueira', 'Affiliation': 'IMIP - Instituto de Medicina Integral Professor Fernando Figueira -, Recife, Brazil.'}, {'ForeName': 'Roque A', 'Initials': 'RA', 'LastName': 'Junior', 'Affiliation': 'HUPES-Hospital Universitário Prof Edgard Santos -, Salvador, Brazil.'}, {'ForeName': 'Valdir A', 'Initials': 'VA', 'LastName': 'Moisés', 'Affiliation': 'UNIFESP -, São Paulo, Brazil.'}, {'ForeName': 'Cezar E', 'Initials': 'CE', 'LastName': 'Mesas', 'Affiliation': 'Hospital de Universidade Estadual de Londrina -, Londrina, Brazil.'}, {'ForeName': 'Roberto V', 'Initials': 'RV', 'LastName': 'Ardito', 'Affiliation': 'IMC - Instituto de Moléstias Cardiovasculares -, São José do Rio Preto, Brazil.'}, {'ForeName': 'Paulo S A', 'Initials': 'PSA', 'LastName': 'Kalil', 'Affiliation': 'Hospital de Clínicas de Porto Alegre -, Porto Alegre, Brazil.'}, {'ForeName': 'Maria S M O', 'Initials': 'MSMO', 'LastName': 'Paiva', 'Affiliation': 'Eurolatino Natal Center -, Natal, Brazil.'}, {'ForeName': 'Jaime G A', 'Initials': 'JGA', 'LastName': 'Maldonado', 'Affiliation': 'Serviço de Eletrofisiologia e Marca-Passo do Hospital Universitário Francisca Mendes (HUFM)-Manaus, Brazil.'}, {'ForeName': 'Carlos E B', 'Initials': 'CEB', 'LastName': 'de Lima', 'Affiliation': 'Cardiolima Piauí -, Teresina, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': ""D'Oliveira Vieira"", 'Affiliation': 'Hospital e Clínica São Roque -, Ipiaú, Brazil.'}, {'ForeName': 'Ligia', 'Initials': 'L', 'LastName': 'Laranjeira', 'Affiliation': 'Research Institute - Heart Hospital (HCor) -, São Paulo, Brazil.'}, {'ForeName': 'Flávia', 'Initials': 'F', 'LastName': 'Kojima', 'Affiliation': 'Research Institute - Heart Hospital (HCor) -, São Paulo, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Damiani', 'Affiliation': 'Research Institute - Heart Hospital (HCor) -, São Paulo, Brazil.'}, {'ForeName': 'Renato H', 'Initials': 'RH', 'LastName': 'Nakagawa', 'Affiliation': 'Research Institute - Heart Hospital (HCor) -, São Paulo, Brazil.'}, {'ForeName': 'Juliana R Y', 'Initials': 'JRY', 'LastName': 'Dos Santos', 'Affiliation': 'Research Institute - Heart Hospital (HCor) -, São Paulo, Brazil.'}, {'ForeName': 'Bruna S', 'Initials': 'BS', 'LastName': 'Sampaio', 'Affiliation': 'Research Institute - Heart Hospital (HCor) -, São Paulo, Brazil.'}, {'ForeName': 'Viviane B', 'Initials': 'VB', 'LastName': 'Campos', 'Affiliation': 'Research Institute - Heart Hospital (HCor) -, São Paulo, Brazil.'}, {'ForeName': 'Jose F K', 'Initials': 'JFK', 'LastName': 'Saraiva', 'Affiliation': 'Instituto de Pesquisa Clínica de Campinas -, Campinas, Brazil; Sociedade de Cardiologia do Estado de São Paulo (SOCESP).'}, {'ForeName': 'Francisco H', 'Initials': 'FH', 'LastName': 'Fonseca', 'Affiliation': 'UNIFESP -, São Paulo, Brazil; Sociedade de Cardiologia do Estado de São Paulo (SOCESP).'}, {'ForeName': 'Ibraim M', 'Initials': 'IM', 'LastName': 'Pinto', 'Affiliation': 'Sociedade de Cardiologia do Estado de São Paulo (SOCESP).'}, {'ForeName': 'Carlos C', 'Initials': 'CC', 'LastName': 'Magalhães', 'Affiliation': 'Sociedade de Cardiologia do Estado de São Paulo (SOCESP).'}, {'ForeName': 'Joao F M', 'Initials': 'JFM', 'LastName': 'Ferreira', 'Affiliation': 'Incor - Instituto do Coração do HCFMUSP-, São Paulo, Brazil; Sociedade de Cardiologia do Estado de São Paulo (SOCESP).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute (DCRI), Durham-NC, US.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Pavanello', 'Affiliation': 'Research Institute - Heart Hospital (HCor) -, São Paulo, Brazil; Sociedade de Cardiologia do Estado de São Paulo (SOCESP).'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Research Institute - Heart Hospital (HCor) -, São Paulo, Brazil.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Research Institute - Heart Hospital (HCor) -, São Paulo, Brazil; Hospital Israelita Albert Einstein, São Paulo-SP, Brazil; Sociedade de Cardiologia do Estado de São Paulo (SOCESP).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.10.001']
2252,33045271,Final endodontic irrigation with 70% ethanol enhanced calcium hydroxide removal from apical third.,"INTRODUCTION


The purpose of this study was to evaluate the cleanliness of root canal walls and dentinal tubules after attempting to remove the calcium hydroxide dressing with different irrigant solutions and the use of non-activated irrigation (NAI) or passive ultrasonic irrigation (PUI).
METHODS


After root canal instrumentation, eighty single-rooted teeth were filled with calcium hydroxide mixed with propylene glycol and 0.1% rhodamine B dye and inserted into canals with a Lentulo spiral. The calcium hydroxide dressing was initially removed with 10 mL saline solution and reinstrumentation with the master apical file. Then, the samples were randomly assigned into eight experimental groups (n=10), according to the irrigant solution with or without PUI: 2.5% sodium hypochlorite; 17% EDTA-T; 37% phosphoric acid; or 70% ethanol. A final flush with 5 mL of saline solution was performed. The percentage of clean root canal walls, and the depth of clean dentinal tubules were measured with images of confocal laser scanning microscopy. The groups were compared using two-way ANOVA test with Bonferroni post hoc test for the depth analysis, and Kruskal-Wallis with Dunn's post hoc test for the perimeter analysis.
RESULTS


Irrigation with 70% ethanol presented significantly higher percentage of clean root canal walls and higher depth of clean dentinal tubules when compared to irrigation with 2.5% NaOCl and 17% EDTA-T, for both irrigation methods (P<0.05). No differences were observed between NAI or PUI protocols (P>0.05).
CONCLUSIONS


70% ethanol enhanced calcium hydroxide removal from the apical root third when compared to 2.5% NaOCl or 17% EDTA-T.",2020,"RESULTS


Irrigation with 70% ethanol presented significantly higher percentage of clean root canal walls and higher depth of clean dentinal tubules when compared to irrigation with 2.5% NaOCl and 17% EDTA-T, for both irrigation methods (P<0.05).",[],"['calcium hydroxide dressing with different irrigant solutions and the use of non-activated irrigation (NAI) or passive ultrasonic irrigation (PUI', 'saline solution', 'calcium hydroxide mixed with propylene glycol and 0.1% rhodamine B dye and inserted into canals with a Lentulo spiral', 'irrigant solution with or without PUI: 2.5% sodium hypochlorite; 17% EDTA-T; 37% phosphoric acid; or 70% ethanol', 'calcium hydroxide dressing']","['clean root canal walls and higher depth of clean dentinal tubules', 'calcium hydroxide removal', 'percentage of clean root canal walls, and the depth of clean dentinal tubules']",[],"[{'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0073194', 'cui_str': 'Rhodamine B'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0522554', 'cui_str': 'Spiral shape'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0031700', 'cui_str': 'Phosphoric acid'}, {'cui': 'C1381542', 'cui_str': 'Ethanol 70%'}]","[{'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0227017', 'cui_str': 'Dentinal tubules'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",,0.0419279,"RESULTS


Irrigation with 70% ethanol presented significantly higher percentage of clean root canal walls and higher depth of clean dentinal tubules when compared to irrigation with 2.5% NaOCl and 17% EDTA-T, for both irrigation methods (P<0.05).","[{'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'Carlos de Lima Dias-Junior', 'Affiliation': 'Department of Dentistry, Federal University of Santa Catarina (UFSC), Florianópolis, SC, Brazil.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Fonseca de Castro', 'Affiliation': 'Department of Endodontics, School of Dentistry, Federal University of Pará (UFPA), Belém, PA, Brazil.'}, {'ForeName': 'Adriany Dias', 'Initials': 'AD', 'LastName': 'Fernandes', 'Affiliation': 'Department of Endodontics, School of Dentistry, Federal University of Pará (UFPA), Belém, PA, Brazil.'}, {'ForeName': 'Marcella Yasmin', 'Initials': 'MY', 'LastName': 'Reis Guerreiro', 'Affiliation': 'Department of Endodontics, School of Dentistry, Federal University of Pará (UFPA), Belém, PA, Brazil.'}, {'ForeName': 'Emmanuel J N L', 'Initials': 'EJNL', 'LastName': 'Silva', 'Affiliation': 'Department of Endodontics, School of Dentistry, Grande Rio University (UNIGRANRIO), Rio de Janeiro, RJ, Brazil; Department of Endodontics, School of Dentistry, State University of Rio de Janeiro (UERJ), Rio de Janeiro, RJ, Brazil. Electronic address: nogueiraemmanuel@hotmail.com.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Melo da Silva Brandão', 'Affiliation': 'Department of Endodontics, School of Dentistry, Federal University of Pará (UFPA), Belém, PA, Brazil.'}]",Journal of endodontics,['10.1016/j.joen.2020.09.017']
2253,33042571,A pilot study examining the use of Goal Management Training in individuals with obsessive-compulsive disorder.,"Background


Recent meta-analyses point towards cognitive impairments in obsessive-compulsive disorder (OCD), particularly in such executive function subdomains as planning and organization. Scant attention has focused on cognitive remediation strategies that may reduce cognitive dysfunction, with a possible corresponding decrease in symptoms of OCD.
Objective


The aim of this study was to assess the implementation of a standardized cognitive remediation program, Goal Management Training (GMT), in a pilot sample of individuals with OCD.
Method


Nineteen individuals with a primary DSM-5 diagnosis of OCD were randomized to receive either the 9-week GMT program (active group;  n  = 10) or to complete a 9-week waiting period (waitlist control;  n  = 9). Groups were assessed at baseline, post-treatment, and 3-month follow-up. The assessment comprised neuropsychological tasks assessing a variety of cognitive domains, and subjective measures of functioning and of symptom severity.
Results


The active condition showed significant improvements from baseline to post-treatment on measures of inattention, impulsivity, problem-solving, and organization compared to controls. Moreover, whereas the active group reported a significant improvement in subjective cognition over the course of treatment, no such improvement emerged in the waitlist group over this same period. Neither group showed improvement on indices of depressive, anxiety, or OCD-related symptom severity.
Discussion


The results of this small pilot investigation indicate that, although promising, this protocol requires several modifications to be best suited for this population. Replication of these findings is awaited, with current results potentially limited by sample characteristics including motivation to seek and complete treatment, and high attrition at 3-month follow-up ( n  = 6 completers).
Trial Registration


NCT02502604. (December 7, 2018).",2020,"The active condition showed significant improvements from baseline to post-treatment on measures of inattention, impulsivity, problem-solving, and organization compared to controls.","['individuals with obsessive-compulsive disorder', 'individuals with OCD', 'Method\n\n\nNineteen individuals with a primary DSM-5 diagnosis of OCD']","['GMT program (active group;  n  = 10) or to complete a 9-week waiting period (waitlist control', 'standardized cognitive remediation program, Goal Management Training (GMT', 'Goal Management Training']","['inattention, impulsivity, problem-solving, and organization', 'indices of depressive, anxiety, or OCD-related symptom severity', 'subjective cognition']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",19.0,0.0226396,"The active condition showed significant improvements from baseline to post-treatment on measures of inattention, impulsivity, problem-solving, and organization compared to controls.","[{'ForeName': 'Duncan H', 'Initials': 'DH', 'LastName': 'Cameron', 'Affiliation': ""Anxiety Treatment and Research Clinic, St. Joseph's Healthcare Hamilton, Hamilton, ON Canada.""}, {'ForeName': 'Randi E', 'Initials': 'RE', 'LastName': 'McCabe', 'Affiliation': ""Anxiety Treatment and Research Clinic, St. Joseph's Healthcare Hamilton, Hamilton, ON Canada.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rowa', 'Affiliation': ""Anxiety Treatment and Research Clinic, St. Joseph's Healthcare Hamilton, Hamilton, ON Canada.""}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'Homewood Research Institute, Guelph, ON Canada.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'McKinnon', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, ON Canada.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00684-0']
2254,33042579,Posterior segment inflammatory outcomes assessed using fluorescein angiography in the STOP-UVEITIS study.,"Background


Although fluorescein angiography (FA) is a frequently used imaging modality in patients with non-infectious uveitis (NIU), it has not been reliably used for objective assessment of posterior segment inflammatory outcomes in these patients. In this index study we report the posterior segment inflammatory outcomes of two different doses of intravenous (IV) infusions of tocilizumab (TCZ), an IL-6 inhibitor, in eyes with NIU using a semi-quantitative FA scoring system.
Methods


STOP-Uveitis is a randomized, multi-center clinical trial conducted at 5 clinical centers across the United States. The study evaluated the role of TCZ in patients with NIU. Thirty-seven (37) patients with NIU were randomized into one of two treatment groups in a ratio of 1:1. Group 1 received IV infusions of 4 mg/kg TCZ and group 2 received IV infusions of 8 mg/kg TCZ. Infusions were given every 4 weeks in both groups until month 6 (primary endpoint). Posterior segment inflammatory outcomes were assessed by evaluating FA at baseline and month 6 by graders at a central reading center. A previously reported, semi-quantitative, scoring system for FA was used to assess signs that represent ongoing inflammatory processes in the posterior segment. These signs included optic disc hyperfluorescence, macular edema, retinal vascular staining and/or leakage, capillary leakage, retinal capillary nonperfusion, neovascularization of the optic disc, neovascularization elsewhere, pinpoint leaks, and retinal staining and/or subretinal pooling. Statistical significance was set at p < 0.05. Main outcome measures included change in posterior segment inflammation as assessed using FA at month 6.
Results


37 eyes (37 patients) were randomized in the STOP-Uveitis study. 30 eyes were found to be eligible for this sub-study based on study criteria. Seven eyes had ungradable images at either baseline or month 6 and were therefore excluded from the analysis. The reduction in FA inflammatory scores at month 6 were statistically significant in both groups (p < 0.05). The difference between the two groups was not significant (p = 0.351).
Conclusions


IV infusions of tocilizumab (both 4 and 8 mg/kg) are effective in improving posterior segment inflammation in eyes with NIU. A semi-quantitative FA scoring system may be used as a reliable outcome measure for assessment of posterior segment inflammation.ClinicalTrials.gov Identifier: NCT01717170.",2020,The reduction in FA inflammatory scores at month 6 were statistically significant in both groups (p < 0.05).,"['37 eyes (37 patients', 'Thirty-seven (37) patients with NIU', 'eyes with NIU', 'patients with non-infectious uveitis (NIU', 'eyes with NIU using a semi-quantitative FA scoring system', 'patients with NIU', '30 eyes were found to be eligible for this sub-study based on study criteria']","['IV\xa0infusions of 4\xa0mg/kg TCZ', 'IV infusions of 8\xa0mg/kg TCZ', 'intravenous (IV) infusions of tocilizumab (TCZ', 'tocilizumab', 'fluorescein angiography (FA', 'TCZ', 'fluorescein angiography']","['posterior segment inflammation', 'change in posterior segment inflammation', 'optic disc hyperfluorescence, macular edema, retinal vascular staining and/or leakage, capillary leakage, retinal capillary nonperfusion, neovascularization of the optic disc, neovascularization elsewhere, pinpoint leaks, and retinal staining and/or subretinal pooling', 'FA inflammatory scores']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0522525', 'cui_str': 'Semi-quantitative'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}]","[{'cui': 'C0348015', 'cui_str': 'Posterior segment'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0029127', 'cui_str': 'Optic disc structure'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C2699708', 'cui_str': 'Subretinal route'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0721888,The reduction in FA inflammatory scores at month 6 were statistically significant in both groups (p < 0.05).,"[{'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Sadiq', 'Affiliation': 'Department of Ophthalmology, University of Louisville, Louisville, KY USA.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Hassan', 'Affiliation': 'Spencer Center for Vision Research, Byers Eye Institute, Stanford University, 2370 Watson Court, Suite 200, Palo Alto, CA 94303 USA.'}, {'ForeName': 'Rubbia', 'Initials': 'R', 'LastName': 'Afridi', 'Affiliation': 'Spencer Center for Vision Research, Byers Eye Institute, Stanford University, 2370 Watson Court, Suite 200, Palo Alto, CA 94303 USA.'}, {'ForeName': 'Muhammad Sohail', 'Initials': 'MS', 'LastName': 'Halim', 'Affiliation': 'Spencer Center for Vision Research, Byers Eye Institute, Stanford University, 2370 Watson Court, Suite 200, Palo Alto, CA 94303 USA.'}, {'ForeName': 'Diana V', 'Initials': 'DV', 'LastName': 'Do', 'Affiliation': 'Spencer Center for Vision Research, Byers Eye Institute, Stanford University, 2370 Watson Court, Suite 200, Palo Alto, CA 94303 USA.'}, {'ForeName': 'Yasir J', 'Initials': 'YJ', 'LastName': 'Sepah', 'Affiliation': 'Spencer Center for Vision Research, Byers Eye Institute, Stanford University, 2370 Watson Court, Suite 200, Palo Alto, CA 94303 USA.'}, {'ForeName': 'Quan Dong', 'Initials': 'QD', 'LastName': 'Nguyen', 'Affiliation': 'Spencer Center for Vision Research, Byers Eye Institute, Stanford University, 2370 Watson Court, Suite 200, Palo Alto, CA 94303 USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of retina and vitreous,['10.1186/s40942-020-00245-w']
2255,33042654,A Randomised Controlled Trial of Local Infiltration Analgesia Versus Femoral Nerve Block for Postoperative Analgesia Following Total Knee Arthroplasty.,"Background Total knee replacement is often associated with significant postoperative pain. Although the use of a femoral nerve block is well-established, local infiltration analgesia has gained popularity in recent years. We compared single-shot local infiltration analgesia with a single-shot femoral nerve block for patients undergoing primary total knee arthroplasty. Methods A total of 194 patients were randomised to receive either local infiltration analgesia (150 ml bupivacaine 0.067% with adrenaline) or a femoral nerve block (20 ml 0.375% levobupivacaine). Both groups received spinal anaesthesia. The primary outcome measure was the total morphine consumption. Secondary outcome measures included: post-operative pain scores, rehabilitation goals, readiness for discharge, and physical, mental, and functional outcomes, including the Oxford Knee Score (OKS). Results A total of 69 patients in the local infiltration analgesia group and 79 patients in the femoral nerve block group were analysed. Median total morphine consumption was significantly greater in the local infiltration analgesia group as compared to the femoral nerve block group (54.67 mg vs 45 mg, respectively, p=0.0388). The post-operative OKS at six weeks was slightly more improved for the femoral nerve block group than for local infiltration analgesia (12.5 vs 9 point median improvements for the femoral nerve block and local infiltration analgesia groups, respectively, p=0.0261). There were no statistically significant differences in other secondary outcome measures. Conclusion A single-shot femoral nerve block significantly reduces the opioid requirement for primary total knee arthroplasty but is otherwise comparable to single-shot local infiltration analgesia.",2020,"The post-operative OKS at six weeks was slightly more improved for the femoral nerve block group than for local infiltration analgesia (12.5 vs 9 point median improvements for the femoral nerve block and local infiltration analgesia groups, respectively, p=0.0261).","['patients undergoing primary total knee arthroplasty', 'Total Knee Arthroplasty', '69 patients in the local infiltration analgesia group and 79 patients in the femoral nerve block group were analysed', '194 patients']","['Local Infiltration Analgesia Versus Femoral Nerve Block', 'local infiltration analgesia', 'spinal anaesthesia', 'femoral nerve block (20 ml 0.375% levobupivacaine', 'single-shot local infiltration analgesia with a single-shot femoral nerve block', 'bupivacaine 0.067% with adrenaline']","['total morphine consumption', ' post-operative pain scores, rehabilitation goals, readiness for discharge, and physical, mental, and functional outcomes, including the Oxford Knee Score (OKS', 'Median total morphine consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}]","[{'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1320402', 'cui_str': 'Readiness for discharge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",194.0,0.238046,"The post-operative OKS at six weeks was slightly more improved for the femoral nerve block group than for local infiltration analgesia (12.5 vs 9 point median improvements for the femoral nerve block and local infiltration analgesia groups, respectively, p=0.0261).","[{'ForeName': 'Yang Min', 'Initials': 'YM', 'LastName': 'Ng', 'Affiliation': 'Anaesthesiology, Royal Devon & Exeter NHS Foundation Trust, Exeter, GBR.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Martin', 'Affiliation': 'Anaesthesiology, Royal Devon & Exeter NHS Foundation Trust, Exeter, GBR.'}, {'ForeName': 'Hugh B', 'Initials': 'HB', 'LastName': 'Waterson', 'Affiliation': 'Orthopaedic Surgery, Royal Devon & Exeter NHS Foundation Trust, Exeter, GBR.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Green', 'Affiliation': 'Anaesthesiology, University Hospitals Plymouth NHS Trust, Plymouth, GBR.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Preece', 'Affiliation': 'Anaesthesiology, Northern Devon Healthcare NHS Trust, Barnstaple, GBR.'}, {'ForeName': 'Nerida', 'Initials': 'N', 'LastName': 'Robinson', 'Affiliation': 'Anaesthesiology, The Canberra Hospital, Canberra, AUS.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Orthopaedics, Royal Devon & Exeter NHS Foundation Trust, Exeter, GBR.'}, {'ForeName': 'Keith S', 'Initials': 'KS', 'LastName': 'Eyres', 'Affiliation': 'Orthopaedics, Royal Devon & Exeter NHS Foundation Trust, Exeter, GBR.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Toms', 'Affiliation': 'Orthopaedics, Royal Devon & Exeter NHS Foundation Trust, Exeter, GBR.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Simpson', 'Affiliation': 'Anaesthesiology, Royal Devon & Exeter NHS Foundation Trust, Exeter, GBR.'}]",Cureus,['10.7759/cureus.10192']
2256,33042657,Oral Erythromycin Improves the Quality of Endoscopy in Upper Gastrointestinal Bleeding Patients.,"Background Upper gastrointestinal bleeding is a life-threatening emergency. Endoscopy is the therapeutic and diagnostic procedure of choice after initial stabilization of the patient. But the presence of retained blood, blood products, and other residual material in the stomach is a big challenge for endoscopists during urgent endoscopy after acute upper gastrointestinal bleeding. Intravenous erythromycin before endoscopy improves the visualization of gastric and duodenal mucosa in these patients. Use of oral erythromycin is more easy and convenient, so the objective of our study was to assess the effects of oral erythromycin on quality of endoscopy in upper gastrointestinal bleeding patients. Methods This interventional study was conducted at the Department of Medicine, POF Hospital Wah Cantt, Pakistan from January 2019 to December 2019. Patients with clinical evidence of acute upper gastrointestinal bleeding within 12 hours were inducted consecutively. Patients were randomly assigned to erythromycin (500 mg) suspension or placebo, orally three hours before endoscopy. One endoscopist performed all the procedures with the same double-channel video endoscope. The primary endpoint was endoscopic quality. The secondary endpoints were the need for second-look endoscopy within 48 hours, endoscopy related complications, therapeutic procedure performed or not during endoscopy, number of blood transfusions, and length of hospital stay. Results A total of 60 patients were included in the study; 30 received erythromycin and 30 received placebo. Out of these, 60% were male and 40% were female. The mean age was 53.68 ± 16.64. Quality of endoscopy was much better in the erythromycin group (83.3%) as compared to placebo (40%). Erythromycin did not shorten the endoscopic duration (15.53 vs. 14.33 minutes in the placebo group; p=0.216) and length of hospital stay (5.23 in erythromycin vs. 5.40 days in placebo group; p=0.807). Statistically no significant association was found between use of erythromycin and establishment of cause of bleed, need for second-look endoscopy, number of blood transfusions and number of endoscopic therapeutic procedures. Conclusion Erythromycin oral suspension before endoscopy in patients with acute upper gastrointestinal bleeding produced good quality of endoscopy in our study. It improved the visualization of gastric and duodenal mucosa significantly. However, it did not shorten the duration of endoscopy or hospital stay. There was no significant difference in number of second-look endoscopies and blood transfusions as well.",2020,Quality of endoscopy was much better in the erythromycin group (83.3%) as compared to placebo (40%).,"['Patients with clinical evidence of acute upper gastrointestinal bleeding within 12 hours were inducted consecutively', 'upper gastrointestinal bleeding patients', 'A total of 60 patients were included in the study; 30 received', '60% were male and 40% were female', 'patients with acute upper gastrointestinal bleeding', 'Department of Medicine, POF Hospital Wah Cantt, Pakistan from January 2019 to December 2019', 'Upper Gastrointestinal Bleeding Patients']","['Oral Erythromycin', 'Erythromycin', 'erythromycin', 'placebo', 'erythromycin (500 mg) suspension or placebo', 'Intravenous erythromycin', 'Erythromycin oral suspension']","['cause of bleed, need for second-look endoscopy, number of blood transfusions and number of endoscopic therapeutic procedures', 'need for second-look endoscopy within 48 hours, endoscopy related complications, therapeutic procedure performed or not during endoscopy, number of blood transfusions, and length of hospital stay', 'visualization of gastric and duodenal mucosa', 'Quality of Endoscopy', 'endoscopic duration', 'number of second-look endoscopies and blood transfusions', 'length of hospital stay', 'duration of endoscopy or hospital stay', 'endoscopic quality', 'Quality of endoscopy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0266809', 'cui_str': 'Acute upper gastrointestinal hemorrhage'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal bleeding'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0025322', 'cui_str': 'Premature menopause'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0360341', 'cui_str': 'Erythromycin-containing product in oral dose form'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1246106', 'cui_str': 'Erythromycin Oral Suspension'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0949626', 'cui_str': 'Incision and reexploration for second look'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0227284', 'cui_str': 'Duodenal mucous membrane structure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",60.0,0.154842,Quality of endoscopy was much better in the erythromycin group (83.3%) as compared to placebo (40%).,"[{'ForeName': 'Syed Asim', 'Initials': 'SA', 'LastName': 'Ali Shah', 'Affiliation': 'Medicine, Wah Medical College, Wah Cantt, PAK.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Nadeem', 'Affiliation': 'Medicine, Poonch Medical College, Rawalakot, PAK.'}, {'ForeName': 'Muzamil', 'Initials': 'M', 'LastName': 'Jameel', 'Affiliation': 'Medicine, Wah Medical College, Wah Cantt, PAK.'}, {'ForeName': 'Rifat', 'Initials': 'R', 'LastName': 'Yasmin', 'Affiliation': 'Medicine, Wah Medical College, Wah Cantt, PAK.'}, {'ForeName': 'Anum', 'Initials': 'A', 'LastName': 'Afsar', 'Affiliation': 'Medicine, Wah Medical College, Wah Cantt, PAK.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Riaz', 'Affiliation': 'Medicine, Wah Medical College, Wah Cantt, PAK.'}]",Cureus,['10.7759/cureus.10204']
2257,33042831,Prognostic and Treatment Guiding Significance of MRI-Based Tumor Burden Features and Nodal Necrosis in Nasopharyngeal Carcinoma.,"We aimed to develop a nomogram integrating MRI-based tumor burden features (MTBF), nodal necrosis, and some clinical factors to forecast the distant metastasis-free survival (DMFS) of patients suffering from non-metastatic nasopharyngeal carcinoma (NPC). A total of 1640 patients treated at Sun Yat-sen University Cancer Center (Guangzhou, China) from 2011 to 2016 were enrolled, among which 1148 and 492 patients were randomized to a training cohort and an internal validation cohort, respectively. Additionally, 200 and 257 patients were enrolled in the Foshan and Dongguan validation cohorts, respectively, which served as independent external validation cohorts. The MTBF were developed from the stepwise regression of six multidimensional tumor burden variables, based on which we developed a nomogram also integrating nodal necrosis and clinical features. This model divided the patients into high- and low-risk groups by an optimal cutoff. Compared with those of patients in the low-risk group, the DMFS [hazard ratio (HR): 4.76, 95% confidence interval (CI): 3.39-6.69;  p  < 0.0001], and progression-free survival (PFS; HR: 4.11, 95% CI: 3.13-5.39;  p  < 0.0001) of patients in the high-risk group were relatively poor. Furthermore, in the training cohort, the 3-year DMFS of high-risk patients who received induction chemotherapy (ICT) combined with concurrent chemoradiotherapy (CCRT) was better than that of those who were treated with CCRT alone ( p  = 0.0340), whereas low-risk patients who received ICT + CCRT had a similar DMFS to those who only received CCRT. The outcomes we obtained were all verified in the three validation cohorts. The survival model can be used as a reliable prognostic tool for NPC patients and is helpful to determine patients who will benefit from ICT.",2020,The survival model can be used as a reliable prognostic tool for NPC patients and is helpful to determine patients who will benefit from ICT.,"['1640 patients treated at Sun Yat-sen University Cancer Center (Guangzhou, China) from 2011 to 2016 were enrolled, among which 1148 and 492 patients', '200 and 257 patients were enrolled in the Foshan and Dongguan validation cohorts, respectively, which served as independent external validation cohorts', 'Nasopharyngeal Carcinoma', 'patients suffering from non-metastatic nasopharyngeal carcinoma (NPC']","['induction chemotherapy (ICT) combined with concurrent chemoradiotherapy (CCRT', 'ICT + CCRT', 'CCRT']","['progression-free survival', '3-year DMFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}]","[{'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",2016.0,0.0656803,The survival model can be used as a reliable prognostic tool for NPC patients and is helpful to determine patients who will benefit from ICT.,"[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Intensive Care Unit, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Bingzhong', 'Initials': 'B', 'LastName': 'Jing', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Information Technology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Weixiong', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Liangru', 'Initials': 'L', 'LastName': 'Ke', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Imaging, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yanqun', 'Initials': 'Y', 'LastName': 'Xiang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Kuiyuan', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Mengyun', 'Initials': 'M', 'LastName': 'Qiang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Chixiong', 'Initials': 'C', 'LastName': 'Liang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jianpeng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, Dongguan People's Hospital, Dongguan, China.""}, {'ForeName': 'Mingyong', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': ""Department of Medical Imaging, The First People's Hospital of Foshan, Foshan, China.""}, {'ForeName': 'Wangzhong', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Guoying', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Zhuochen', 'Initials': 'Z', 'LastName': 'Cai', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Shuhui', 'Initials': 'S', 'LastName': 'Lv', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Chaofeng', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Information Technology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Lv', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.537318']
2258,33042882,The Effectiveness of Visual Pedagogy for Toothbrushing in Children with Autism Spectrum Disorder.,"Objectives


The aim of this study was to evaluate toothbrushing effectiveness in children with mild and moderate levels of severity of autism spectrum disorder (ASD) after using visual pedagogy.
Materials and Methods


This quasi-experimental study was carried out with 30 children with ASD aged 5-17 years; 21 had mild ASD and 9 had moderate ASD. Informed consent and the subject's demographic information were obtained from caregivers. All subjects were then asked to show their toothbrushing practices, which were recorded by video. The toothbrushing ability, toothbrushing cooperation, and plaque index were evaluated before the study and at 2 weeks, 4 weeks, 3 months, and 6 months after visual pedagogy had been used. Results were analyzed by the Friedman test, Pearson's chi-square test, Fisher's exact test, and Mann‒Whitney  U  test.
Results


Toothbrushing ability was significantly improved at all periods of follow-up. Toothbrushing cooperation and the dental plaque index were significantly better than before the study at 4 weeks, 3 months, and 6 months of follow-up. The toothbrushing ability of subjects with mild ASD was significantly better than that of subjects with moderate ASD at 4 weeks and 6 months of follow-up. The toothbrushing cooperation of the mild group was significantly better than that of the moderate group at 2 weeks, 4 weeks, and 3 months. There was no statistically significant reduction in the plaque index between the two groups.
Conclusion


Visual pedagogy is useful for improving toothbrushing effectiveness in children with mild or moderate severity ASD. However, children with moderate severity ASD take longer to improve.",2020,"Toothbrushing cooperation and the dental plaque index were significantly better than before the study at 4 weeks, 3 months, and 6 months of follow-up.","['30 children with ASD aged 5-17 years; 21 had mild ASD and 9 had moderate ASD', 'children with mild and moderate levels of severity of autism spectrum disorder (ASD) after using visual pedagogy', 'children with moderate severity ASD', 'subjects with mild ASD', 'Children with Autism Spectrum Disorder', 'children with mild or moderate severity ASD']",['Visual Pedagogy for Toothbrushing'],"['toothbrushing effectiveness', 'Toothbrushing ability', 'dental plaque index', 'plaque index', 'toothbrushing cooperation', 'toothbrushing ability, toothbrushing cooperation, and plaque index', ""Friedman test, Pearson's chi-square test, Fisher's exact test, and Mann‒Whitney  U  test""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1510624', 'cui_str': 'Pedagogy'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1510624', 'cui_str': 'Pedagogy'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}]","[{'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008041', 'cui_str': 'Chi-Square Test'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}]",30.0,0.0278476,"Toothbrushing cooperation and the dental plaque index were significantly better than before the study at 4 weeks, 3 months, and 6 months of follow-up.","[{'ForeName': 'Apiwan', 'Initials': 'A', 'LastName': 'Smutkeeree', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tippawan', 'Initials': 'T', 'LastName': 'Khrautieo', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sasithorn', 'Initials': 'S', 'LastName': 'Thamseupsilp', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Natchalee', 'Initials': 'N', 'LastName': 'Srimaneekarn', 'Affiliation': 'Department of Anatomy, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Praphasri', 'Initials': 'P', 'LastName': 'Rirattanapong', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Wimonrat', 'Initials': 'W', 'LastName': 'Wanpen', 'Affiliation': 'Child and Adolescent Mental Health Rajanagarindra Institute, Department of Mental Health, Ministry of Public Health, Bangkok, Thailand.'}]",Journal of International Society of Preventive & Community Dentistry,['10.4103/jispcd.JISPCD_248_20']
2259,33042883,"Comparison of the Efficacy of CanalBrush, EndoActivator, and Passive Ultrasonic Irrigation on the Removal of Triple Antibiotic Paste from Root Canal Walls: An  In Vitro  Study.","Aim


The aim of this study was to compare the efficacy of CanalBrush (CB), EndoActivator (EA), and Passive Ultrasonic Irrigation (PUI) on the removal of triple antibiotic paste (TAP) from root canal walls.
Materials and Methods


Thirty-six extracted human single-rooted teeth were prepared using ProTaper Universal rotary files (DentsplyMaillefer, Ballaigues, Switzerland) up to size F5. The root canals were filled with TAP, and after 21 days, roots were randomly assigned to three groups ( n  = 10) according to irrigation regimens used: CB, EA, and PUI. In three teeth, TAP was not removed (positive controls), and the other three teeth were not filled with TAP (negative controls). The roots were sectioned, and the amount of TAP remaining was evaluated at the mesial halves of each tooth at ×30 magnification under a stereomicroscope using a 4-grade scoring system. Data were evaluated using the Kruskal-Wallis and Mann-Whitney  U  tests.
Results


There were significant differences among the experimental groups according to the different parts of the root canals ( P  < 0.05). At the apical and middle third, EA and PUI groups removed more TAP than CB group; however, there was a statistically significant difference only between CB and PUI groups (<0.01 at apical third and <0.05 at middle third). At the coronal third, there was no statistically significant difference between all the three groups ( P  > 0.05).
Conclusion


PUI led to superior results compared to CB in the middle and apical thirds. There was no significant difference between EA and PUI techniques.",2020,"At the coronal third, there was no statistically significant difference between all the three groups ( P  > 0.05).
",['Root Canal Walls'],"['CanalBrush, EndoActivator, and Passive Ultrasonic Irrigation', 'triple antibiotic paste (TAP', 'CanalBrush (CB), EndoActivator (EA), and Passive Ultrasonic Irrigation (PUI']",[],"[{'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0205380', 'cui_str': 'Walled'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}]",[],36.0,0.0262513,"At the coronal third, there was no statistically significant difference between all the three groups ( P  > 0.05).
","[{'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Patna Dental College & Hospital, Patna, Bihar, India.'}, {'ForeName': 'Kavisha', 'Initials': 'K', 'LastName': 'Desai', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Rural Dental College, Pravara Institute of Medical Sciences (PIMS), Loni, Maharashtra, India.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Palekar', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Rural Dental College, Pravara Institute of Medical Sciences (PIMS), Loni, Maharashtra, India.'}, {'ForeName': 'Baswaraj', 'Initials': 'B', 'LastName': 'Biradar', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Rural Dental College, Pravara Institute of Medical Sciences (PIMS), Loni, Maharashtra, India.'}, {'ForeName': 'Ananjan', 'Initials': 'A', 'LastName': 'Chatterjee', 'Affiliation': 'Department of Oral Pathology, Buddha Institute of Dental Sciences & Hospital, Patna, Bihar, India.'}, {'ForeName': 'Khushboo', 'Initials': 'K', 'LastName': 'Kumari', 'Affiliation': 'Department of Oral Pathology, Buddha Institute of Dental Sciences & Hospital, Patna, Bihar, India.'}]",Journal of International Society of Preventive & Community Dentistry,['10.4103/jispcd.JISPCD_13_20']
2260,33042895,"A Novel, Simple, Frequent Oral Cleaning Method Reduces Damaging Bacteria in the Dental Microbiota.","Aim


Dental diseases can be prevented by reducing early bacterial colonization in biofilm, a precursor to mature dental plaque. Most studies on dental disease pathogenesis focus on mature plaque and fail to address the impact of oral cleaning on biofilm formation. Here we used next-generation metagenomics to assess the effects of a new method of regular, simple biofilm disruption on the oral metagenome.
Materials and Methods


This was a randomized, controlled study of 45 healthy children divided into three groups. Participants avoided oral cleaning for 3 days and then performed 10 days of oral cleaning either by: (1) brushing and tongue cleaning twice a day (BT) with toothpaste; (2) Gum and tooth rubbing with Index Finger Tongue cleaning and water Swishing (GIFTS) after each meal, snack, and drink; or (3) GIFTS twice a day with nano-charcoal and tongue cleaning (CT) ( n  = 15 per group). Saliva, plaque, and tongue scraping samples were collected on day 0 and 10 for quantitative polymerase chain reaction (qPCR) and next-generation metagenomics sequencing to analyze microbiome taxa differences between groups.
Results


GIFTS more significantly reduced ( P  < 0.004) total bacteria in saliva than BT ( P  < 0.02). Metagenomics revealed a significant reduction in Firmicutes in GIFTS and CT tongue samples compared to BT samples. BT and CT saliva samples showed significantly more  Streptococcus  species than GIFTS saliva samples. In the plaque samples, GIFTS cleaning significantly reduced early colonizers, including  Streptococcus,  compared to the BT and CT methods.
Conclusion


Here, we introduce the ""frequent disruption of biofilm"" concept for enhanced oral hygiene. GIFTS can be used to prevent early bacterial colonization of biofilm and plaque formation in both small children and adults. Frequent biofilm disturbance more effectively disrupts early bacterial colonization than twice oral cleaning, is nonabrasive, and is, therefore, a practical and straightforward complement to regular toothbrushing for improved oral hygiene and disease prevention.",2020,"In the plaque samples, GIFTS cleaning significantly reduced early colonizers, including  Streptococcus,  compared to the BT and CT methods.
",['45 healthy children divided into three groups'],"['GIFTS', 'oral cleaning either by: (1) brushing and tongue cleaning twice a day (BT) with toothpaste; (2) Gum and tooth rubbing with Index Finger Tongue cleaning and water Swishing (GIFTS) after each meal, snack, and drink; or (3) GIFTS twice a day with nano-charcoal and tongue cleaning (CT']","['total bacteria in saliva', 'BT and CT saliva samples', 'Saliva, plaque, and tongue scraping samples']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0016999', 'cui_str': 'Gamete intrafallopian transfer'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0230388', 'cui_str': 'Index finger structure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C1699290', 'cui_str': 'Swish'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0007955', 'cui_str': 'Charcoal'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0444082', 'cui_str': 'Scrapings'}]",45.0,0.0329745,"In the plaque samples, GIFTS cleaning significantly reduced early colonizers, including  Streptococcus,  compared to the BT and CT methods.
","[{'ForeName': 'Pranav', 'Initials': 'P', 'LastName': 'Chhaliyil', 'Affiliation': 'MSAE School, Fairfield, Iowa, USA.'}, {'ForeName': 'Kael F', 'Initials': 'KF', 'LastName': 'Fischer', 'Affiliation': 'Department of Pathology, University of Utah School of Medicine, Salt Lake, Utah, USA.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Schoel', 'Affiliation': 'Foodchain ID, Fairfield, Iowa, USA.'}, {'ForeName': 'Pradheep', 'Initials': 'P', 'LastName': 'Chhalliyil', 'Affiliation': 'Foodchain ID, Fairfield, Iowa, USA.'}]",Journal of International Society of Preventive & Community Dentistry,['10.4103/jispcd.JISPCD_31_20']
2261,33042911,Effect of Different Milk Diet on the Level of Fecal Calprotectin in Very Preterm Infants.,"Objective:  To evaluate the course of fecal calprotectin (FC) in very preterm infants over the first 15 days of life in relation to the type of milk diet.  Methods:  This study was part of a randomized controlled trial comparing two different ways of integrating the own mother's milk (OMM) for the evaluation of feeding tolerance in very preterm infants. In infants with gestational age of ≤ 32 weeks randomized to receive preterm formula (PF group) or pasteurized donor human milk (PDHM group) as a supplement to the OMM insufficient or unavailable, FC level was planned to be measured at the first meconium passage and at days 8 and 15 of life (T0, T1, and T2, respectively).  Results:  FC data were available for all the 70 infants randomized, 35 in the PF group, and 35 in the PDHM group. The mean FC levels were similar in the two study groups at T0 and T1, whereas they were significantly higher in the PF group than the PDHM group at T2. FC values decreased over the first week of life in both groups and significantly increased over the second week of life only in the PF group.  Conclusions:  Our study demonstrates a significant increase in FC levels when PF is used as a supplement to the OMM compared to the use of PDHM. Further studies are needed to establish if the higher FC levels in infants receiving PF are the expression of a normal immunological maturation rather than an initial inflammatory process.",2020,"The mean FC levels were similar in the two study groups at T0 and T1, whereas they were significantly higher in the PF group than the PDHM group at T2.","['very preterm infants', 'Very Preterm Infants']","['PDHM', 'Different Milk Diet', 'preterm formula (PF group) or pasteurized donor human milk (PDHM group']","['Level of Fecal Calprotectin', 'fecal calprotectin (FC', 'FC levels', 'mean FC levels', 'FC values']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",70.0,0.0329423,"The mean FC levels were similar in the two study groups at T0 and T1, whereas they were significantly higher in the PF group than the PDHM group at T2.","[{'ForeName': 'Simonetta', 'Initials': 'S', 'LastName': 'Costa', 'Affiliation': 'Department of Woman and Child Health and Public Health, Child Health Area, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Maria Letizia', 'Initials': 'ML', 'LastName': 'Patti', 'Affiliation': 'Department of Woman and Child Health and Public Health, Child Health Area, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Perri', 'Affiliation': 'Department of Woman and Child Health and Public Health, Child Health Area, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Cocca', 'Affiliation': 'Department of Woman and Child Health and Public Health, Child Health Area, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Pinna', 'Affiliation': 'Department of Woman and Child Health and Public Health, Child Health Area, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Tirone', 'Affiliation': 'Department of Woman and Child Health and Public Health, Child Health Area, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Tana', 'Affiliation': 'Department of Woman and Child Health and Public Health, Child Health Area, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Lio', 'Affiliation': 'Department of Woman and Child Health and Public Health, Child Health Area, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Vento', 'Affiliation': 'Department of Woman and Child Health and Public Health, Child Health Area, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}]",Frontiers in pediatrics,['10.3389/fped.2020.00552']
2262,33042934,"A Community-Based Lifestyle-Integrated Physical Activity Intervention to Enhance Physical Activity, Positive Family Communication, and Perceived Health in Deprived Families: A Cluster Randomized Controlled Trial.","Background:  Zero-time exercise (ZTEx) is an approach integrating simple strength- and stamina-enhancing physical activity into daily life. The study evaluated the effectiveness of a community-based lifestyle-integrated physical activity intervention using ZTEx to enhance participants' physical activity, family communication, perceived health and happiness, and family harmony.  Methods:  A parallel group, cluster randomized controlled trial was conducted in a sample of 673 participants from eight Integrated Family Service Centers in Hong Kong. The experimental group ( n  = 316) received a physical activity intervention. The control group ( n  = 357) received information on healthy eating. Both groups received three face-to-face intervention sessions (totalling 6 h and 30 min) and 16 text messages. The primary outcome was the change in days spent engaged in ZTEx. Secondary outcomes included changes in sitting time, days engaged in moderate or vigorous physical activities, family communication (encouraging and engaging family members in ZTEx), dietary habits, perceived health and happiness, and family harmony. Self-administered questionnaires were used at baseline and at 3, 6, and 12 months. Mixed effects models with intention-to-treat analysis was used.  Results:  Compared with the control group at 3 months, the experimental group showed significantly greater increases of 1.3 days spent doing ZTEx (Cohen's  d : 0.60), 0.3 days spent doing moderate physical activity (Cohen's  d : 0.08), 0.3 days encouraging family members to do ZTEx (Cohen's  d : 0.16), and 0.7 days doing ZTEx with family members (Cohen's  d : 0.39) during the 7 days prior. At 3 months, the experimental group also showed a significantly greater improvement in perceived health, by a score of 0.2 (Cohen's  d : 0.14). The effect sizes ranged from small to medium, with similar intervention effects at the 6-month and 1-year assessments. Compared with the experimental group, the control group showed a significantly greater reduction of 0.4 days on which sweetened beverages were consumed (95% CI: 0.01, 0.9,  p  < 0.05, Cohen's  d : 0.28). The qualitative results supported the quantitative findings.  Conclusions:  Our findings show that a community-based lifestyle-integrated physical activity (PA) intervention can enhance physical activity, family communication, and perceived health in deprived families in Hong Kong.  Trial registration:  The research protocol was retrospectively registered at the National Institutes of Health (identifier number: NCT02601534) on November 10, 2015.",2020,"The effect sizes ranged from small to medium, with similar intervention effects at the 6-month and 1-year assessments.","['673 participants from eight Integrated Family Service Centers in Hong Kong', 'Deprived Families']","['physical activity intervention', 'community-based lifestyle-integrated physical activity intervention using ZTEx', ':  Zero-time exercise (ZTEx', 'Community-Based Lifestyle-Integrated Physical Activity Intervention', 'community-based lifestyle-integrated physical activity (PA) intervention']","['changes in sitting time, days engaged in moderate or vigorous physical activities, family communication (encouraging and engaging family members in ZTEx), dietary habits, perceived health and happiness, and family harmony', 'moderate physical activity', ""participants' physical activity, family communication, perceived health and happiness, and family harmony"", 'perceived health', 'change in days spent engaged in ZTEx']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}]",673.0,0.0816431,"The effect sizes ranged from small to medium, with similar intervention effects at the 6-month and 1-year assessments.","[{'ForeName': 'Agnes Y K', 'Initials': 'AYK', 'LastName': 'Lai', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Eliza Y W', 'Initials': 'EYW', 'LastName': 'Lam', 'Affiliation': 'Caritas-Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Fabrizo', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Dickson P K', 'Initials': 'DPK', 'LastName': 'Lee', 'Affiliation': 'Caritas-Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Alice N T', 'Initials': 'ANT', 'LastName': 'Wan', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Jessica S Y', 'Initials': 'JSY', 'LastName': 'Tsang', 'Affiliation': 'Caritas-Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Lai-Ming', 'Initials': 'LM', 'LastName': 'Ho', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Sunita M', 'Initials': 'SM', 'LastName': 'Stewart', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, United States.'}, {'ForeName': 'Tai-Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong, Hong Kong.'}]",Frontiers in public health,['10.3389/fpubh.2020.00434']
2263,33043047,Post hoc  analysis of a randomised controlled trial: effect of vitamin D supplementation on circulating levels of desmosine in COPD.,"Background


Vitamin D supplementation lowers exacerbation frequency in severe vitamin D-deficient patients with COPD. Data regarding the effect of vitamin D on elastin degradation are lacking. Based on the vitamin's anti-inflammatory properties, we hypothesised that vitamin D supplementation reduces elastin degradation, particularly in vitamin D-deficient COPD patients. We assessed the effect of vitamin D status and supplementation on elastin degradation by measuring plasma desmosine, a biomarker of elastin degradation.
Methods


Desmosine was measured every 4 months in plasma of 142 vitamin D-naïve COPD patients from the Leuven vitamin D intervention trial (100 000 IU vitamin D3 supplementation every 4 weeks for 1 year).
Results


No significant association was found between baseline 25-hydroxyvitamin D (25(OH)D) and desmosine levels. No significant difference in desmosine change over time was found between the placebo and intervention group during the course of the trial. In the intervention arm, an unexpected inverse association was found between desmosine change and baseline 25(OH)D levels (p=0.005).
Conclusions


Vitamin D supplementation did not have a significant overall effect on elastin degradation compared to placebo. Contrary to our hypothesis, the intervention decelerated elastin degradation in vitamin D-sufficient COPD patients and not in vitamin D-deficient subjects.",2020,No significant association was found between baseline 25-hydroxyvitamin D (25(OH)D) and desmosine levels.,['severe vitamin D-deficient patients with COPD'],"['vitamin D supplementation', 'vitamin D', '\n\n\nVitamin D supplementation', 'placebo', 'vitamin D status and supplementation', 'vitamin D3 supplementation']","['baseline 25-hydroxyvitamin D (25(OH)D) and desmosine levels', 'desmosine change over time', 'elastin degradation', 'circulating levels of desmosine in COPD', 'desmosine change and baseline 25(OH)D levels']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013765', 'cui_str': 'Elastin'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]",100000.0,0.27712,No significant association was found between baseline 25-hydroxyvitamin D (25(OH)D) and desmosine levels.,"[{'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Janssen', 'Affiliation': 'Dept of Pulmonary Medicine, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Jef', 'Initials': 'J', 'LastName': 'Serré', 'Affiliation': 'Laboratory of Respiratory Diseases, Catholic University Leuven, Leuven, Belgium.'}, {'ForeName': 'Ianthe', 'Initials': 'I', 'LastName': 'Piscaer', 'Affiliation': 'Dept of Respiratory Medicine, Maastricht University Medical Centre+, Maastricht, The Netherlands.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Zaal', 'Affiliation': 'Ziekenhuisgroep Twente, Hengelo, The Netherlands.'}, {'ForeName': 'Henny', 'Initials': 'H', 'LastName': 'van Daal', 'Affiliation': 'Clinical Chemistry, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Carolien', 'Initials': 'C', 'LastName': 'Mathyssen', 'Affiliation': 'Laboratory of Respiratory Diseases, Catholic University Leuven, Leuven, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Zanen', 'Affiliation': 'Dept of Respiratory Medicine, Division of Heart and Lungs, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Jody M W', 'Initials': 'JMW', 'LastName': 'van den Ouweland', 'Affiliation': 'Clinical Chemistry, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Janssens', 'Affiliation': 'Laboratory of Respiratory Diseases, Catholic University Leuven, Leuven, Belgium.'}]",ERJ open research,['10.1183/23120541.00128-2019']
2264,33043067,Enhanced performance on a sentence comprehension task in congenitally blind adults.,"People born blind habitually experience linguistic utterances in the absence of visual cues and activate ""visual"" cortices during sentence comprehension. Do blind individuals show superior performance on sentence processing tasks? Congenitally blind (n=25) and age and education matched sighted (n=52) participants answered yes/no who-did-what-to-whom questions for auditorily-presented sentences, some of which contained a grammatical complexity manipulation (long-distance movement dependency or garden path). Short-term memory was measured with a forward and backward letter-spans. A battery of control tasks included two speeded math tasks and vocabulary and reading tasks from Woodcock Johnson III. The blind group outperformed the sighted on the sentence comprehension task, particularly for garden-path sentences, and on short-term memory span tasks, but performed similar to the sighted on control tasks. Sentence comprehension performance was not correlated with span performance, suggesting independent enhancements.",2020,"The blind group outperformed the sighted on the sentence comprehension task, particularly for garden-path sentences, and on short-term memory span tasks, but performed similar to the sighted on control tasks.","['Congenitally blind (n=25) and age and education matched sighted (n=52) participants', 'congenitally blind adults']","['control tasks included two speeded math tasks and vocabulary and reading tasks from Woodcock Johnson III', 'sighted on the sentence comprehension task, particularly for garden-path sentences, and on short-term memory span tasks, but performed similar to the sighted on control tasks', 'answered yes/no who-did-what-to-whom questions for auditorily-presented sentences, some of which contained a grammatical complexity manipulation (long-distance movement dependency or garden path']","['sentence comprehension task', 'Sentence comprehension performance']","[{'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0325810', 'cui_str': 'Woodcock'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}]","[{'cui': 'C0162340', 'cui_str': 'Understanding'}]",52.0,0.0366742,"The blind group outperformed the sighted on the sentence comprehension task, particularly for garden-path sentences, and on short-term memory span tasks, but performed similar to the sighted on control tasks.","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Loiotile', 'Affiliation': 'Department of Psychological and Brain Sciences, Johns Hopkins University, 3400 N. Charles Street, Baltimore, MD 21218.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Lane', 'Affiliation': 'Department of Psychological and Brain Sciences, Johns Hopkins University, 3400 N. Charles Street, Baltimore, MD 21218.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Omaki', 'Affiliation': 'Department of Psychological and Brain Sciences, Johns Hopkins University, 3400 N. Charles Street, Baltimore, MD 21218.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Bedny', 'Affiliation': 'Department of Psychological and Brain Sciences, Johns Hopkins University, 3400 N. Charles Street, Baltimore, MD 21218.'}]","Language, cognition and neuroscience",['10.1080/23273798.2019.1706753']
2265,33043107,The impact of assistive technology on burden and psychological well-being in informal caregivers of people with dementia (ATTILA Study).,"Introduction


Assistive technology and telecare (ATT) may alleviate psychological burden in informal caregivers of people with dementia. This study assessed the impact of ATT on informal caregivers' burden and psychological well-being.
Methods


Individuals with dementia and their informal caregivers were recruited to a randomized-controlled trial assessing effectiveness of ATT. Caregivers were allocated to two groups according to their cared-for person's randomization to a full or basic package of ATT and were assessed on caregiver burden, state anxiety, and depression. Caregivers' data from three assessments over 6 months of the trial were analyzed.
Results


No significant between- or within-group differences at any time point on caregivers' burden, anxiety, and depression levels were found.
Discussion


Full ATT for people with dementia did not impact caregivers' psychological outcomes compared to basic ATT. The length of follow up was restricted to 6 months.",2020,"No significant between- or within-group differences at any time point on caregivers' burden, anxiety, and depression levels were found.
","['Individuals with dementia and their informal caregivers', 'people with dementia', 'informal caregivers of people with dementia']","['Introduction\n\n\nAssistive technology and telecare (ATT', 'assistive technology']","[""caregivers' burden, anxiety, and depression levels""]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}]","[{'cui': 'C0036605', 'cui_str': 'Assistive equipment'}, {'cui': 'C3886195', 'cui_str': '2-amino-5-mercapto-1,3,4-thiadiazole'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",,0.083522,"No significant between- or within-group differences at any time point on caregivers' burden, anxiety, and depression levels were found.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Davies', 'Affiliation': 'School of Health Sciences City University of London London UK.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Brini', 'Affiliation': 'School of Health Sciences City University of London London UK.'}, {'ForeName': 'Shashivadan', 'Initials': 'S', 'LastName': 'Hirani', 'Affiliation': 'School of Health Sciences City University of London London UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gathercole', 'Affiliation': 'Department of Old Age Psychiatry Institute of Psychiatry London UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Forsyth', 'Affiliation': 'School of Health Sciences Queen Margaret University Edinburgh UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Henderson', 'Affiliation': 'South London and Maudsley NHS Foundation Trust London UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Bradley', 'Affiliation': 'Clinical Trial Service Unit Oxford UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Davies', 'Affiliation': 'Clinical Trial Service Unit Oxford UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Dunk', 'Affiliation': 'South London and Maudsley NHS Foundation Trust London UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Harper', 'Affiliation': 'Clinical Trial Service Unit Oxford UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Lam', 'Affiliation': 'Clinical Trial Service Unit Oxford UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Pank', 'Affiliation': 'Medical Research Council Population Health Research Unit Oxford University Oxford UK.'}, {'ForeName': 'Iracema', 'Initials': 'I', 'LastName': 'Leroi', 'Affiliation': 'Global Brain Health Institute Trinity College Dublin Dublin 2 Ireland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Woolham', 'Affiliation': ""Social Care Workforce Research Unit King's College London London UK.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Fox', 'Affiliation': 'School of Medicine Health Policy and Practice University of East Anglia Norwich Norfolk UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Psychiatry University of Cambridge Cambridge UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bateman', 'Affiliation': 'Oliver Zangwill Centre for Neuropsychological Rehabilitation Princess of Wales Hospital Ely UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Poland', 'Affiliation': 'School of Allied Health Professionals University of East Anglia Norwich Norfolk UK.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Bentham', 'Affiliation': 'The Barberry Centre Birmingham UK.'}, {'ForeName': 'Alistar', 'Initials': 'A', 'LastName': 'Burns', 'Affiliation': 'Global Brain Health Institute Trinity College Dublin Dublin 2 Ireland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gray', 'Affiliation': 'Clinical Trial Service Unit Oxford UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Knapp', 'Affiliation': 'Department of Old Age Psychiatry Institute of Psychiatry London UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Talbot', 'Affiliation': 'Norfolk and Suffolk NHS Foundation Trust Suffolk UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hooper', 'Affiliation': 'Lancashire Care NHS Foundation Trust Preston UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Winson', 'Affiliation': 'Cambridgeshire Community Services NHS Trust Oliver Zangwill Centre Ely UK.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Scutt', 'Affiliation': 'Department of Old Age Psychiatry Institute of Psychiatry London UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ordonez', 'Affiliation': 'Cambridgeshire Community Services NHS Trust Oliver Zangwill Centre Ely UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Nunn', 'Affiliation': 'Cambridgeshire Community Services NHS Trust Oliver Zangwill Centre Ely UK.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Lavelle', 'Affiliation': 'Department of Old Age Psychiatry Institute of Psychiatry London UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Howard', 'Affiliation': 'Division of Psychiatry University College London London UK.'}, {'ForeName': 'Stanton', 'Initials': 'S', 'LastName': 'Newman', 'Affiliation': 'School of Health Sciences City University of London London UK.'}]","Alzheimer's & dementia (New York, N. Y.)",['10.1002/trc2.12064']
2266,33043148,Long-term outcomes of therapist-guided Internet-delivered cognitive behavior therapy for pediatric obsessive-compulsive disorder.,"Cognitive behavior therapy (CBT) is the recommended first-line intervention for children and adolescents with obsessive-compulsive disorder (OCD), but is not broadly accessible. Internet-delivered CBT (ICBT) with minimal therapist support is efficacious and cost-effective, at least in the short term. Whether the therapeutic gains of ICBT for OCD are sustained in the long run is unknown. In this study, 61 adolescents with OCD who participated in a randomized trial of ICBT were followed-up 3 and 12 months after treatment. The proportion of treatment responders and remitters remained stable from post-treatment to 3-month follow-up and increased significantly from 3-month to 12-month follow-up. This study suggests that the gains of ICBT for youth with OCD are not only maintained long-term, but that further improvements continue to occur during follow-up.",2020,The proportion of treatment responders and remitters remained stable from post-treatment to 3-month follow-up and increased significantly from 3-month to 12-month follow-up.,"['pediatric obsessive-compulsive disorder', 'children and adolescents with obsessive-compulsive disorder (OCD', '61 adolescents with OCD who participated in a randomized trial of']","['therapist-guided Internet-delivered cognitive behavior therapy', 'Internet-delivered CBT (ICBT', 'Cognitive behavior therapy (CBT', 'ICBT']",[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],61.0,0.0301225,The proportion of treatment responders and remitters remained stable from post-treatment to 3-month follow-up and increased significantly from 3-month to 12-month follow-up.,"[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Lenhard', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, 171 77 Region Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mataix-Cols', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, 171 77 Region Stockholm, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rück', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, 171 77 Region Stockholm, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Aspvall', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, 171 77 Region Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Serlachius', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, 171 77 Region Stockholm, Sweden.'}]",NPJ digital medicine,['10.1038/s41746-020-00327-x']
2267,33043163,Remdesivir for coronavirus 2019 (COVID-19): More promising but still unproven.,"From December 2019 to May 22, 2020 the emerging and ever-increasing pandemic of coronavirus 19 (COVID-19) had no effective and safe treatment. Not surprisingly, remdesivir attracted worldwide attention. In a trial published online ahead of print, of 1063 patients, 541 were assigned at random to remdesivir and 522 to placebo. The primary prespecified endpoint was mean recovery time and patients assigned to remdesivir had a mean recovery time of 11 days versus 15 days for those assigned a random to placebo. (p < 0.001). With respect to mortality, the prespecfied secondary endpoint, 34/538 patients in remdesivir and 54/521 in placebo died after 28 days, yielding a possible 31% reduction that approached but did not achieve statistical significance (p = 0.059). The only other published trial of remdesivir randomized 237 patients in China. In that trial, 178 patients were assigned at random to remdesivir compared to 79 assigned to placebo. Those assigned at random to remdesivir experienced a possible but nonsignificant 23% faster time to clinical improvement of 21 days compared with 23 for those assigned to placebo [hazard ratio 1.23 [95% CI, 0·87-1.75)]. With respect to mortality there was no suggestion of any benefit. In fact, the mortality rate in those receiving remdesivir was 15% (22/150) compared with 13% (10/77) for those assigned to placebo. Ongoing randomized trials should be designed, conducted and analyzed to provide the necessary reliable data on mortality to resolve the remaining clinical uncertainties.",2020,With respect to mortality there was no suggestion of any benefit.,"['1063 patients, 541 were assigned at random to remdesivir and 522 to', 'Remdesivir for coronavirus 2019 (COVID-19', '237 patients in China', '178 patients']",['placebo'],"['mean recovery time', 'mortality rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C4517804', 'cui_str': '522'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",237.0,0.308104,With respect to mortality there was no suggestion of any benefit.,"[{'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Shih', 'Affiliation': 'Charles E. Schmidt College of Medicine, Florida Atlantic University, Departments of Emergency Medicine, Bethesda Hospital East and Delray Medical Center, USA.'}, {'ForeName': 'Dennis G', 'Initials': 'DG', 'LastName': 'Maki', 'Affiliation': 'University of Wisconsin School of Medicine & Public Health, USA.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hennekens', 'Affiliation': 'First Sir Richard Doll Professor & Senior Academic Advisor to the Dean Charles E. Schmidt College of Medicine, Florida Atlantic University, 2800, S. Ocean Blvd. PHA Boca Raton, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100663']
2268,33045536,Laser tongue debridement for oral malodor-A novel approach to halitosis.,"STUDY OBJECTIVE


Malodor is a multifactorial condition with oral pathology representing the main culprit and the tongue being the first to second contributor to the malodor. Bacterial load can represent a quantifiable measure regardless of the original pathology. We hypothesize that reduction in malodor can be represented by tongue changes both in appearance, bacterial and biofilm load reduction (measured by CFU and volatile gases measurement), organoleptic measurement and subjective improvement.
METHODS


A randomized controlled prospective study under IRB approval. Diagnostic criteria for enrollment and follow up were organoleptic test by 2 judges, Halimeter reading, tongue colors changes HALT questionnaire and direct aerobic and anaerobic tongue cultures measured by CFU. Patients were treated with laser tongue debridement (LTD) with an Er,Cr:YSGG solid state laser has been shown to be effective in biofilm reduction.
RESULTS


54 patients recruited with 35 available for follow up. Improvement was observed on all objective and QOL subjective parameters. Treatment was tolerated well with minimal discomfort.
CONCLUSIONS


The tongue is proven to be a major contributor to oral malodor and must be addressed in treatment protocol. LTD significantly reduces malodor by subjective and objective criteria. While impossible to determine whether the tongue serves as a bacterial reservoir or is the origin for oral bacteria it is clear that LTD improves oral hygiene and reduces malodor. LTD is safe and easy to perform. We encourage LTD to be a crucial part of any oral malodor treatment protocol.
TRIAL REGISTRATION


clinical trials, NCT04120948. Registered 25 September 2019 - Retrospectively registered, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S00098SX&selectaction=Edit&uid=U0000W0Y&ts=51&cx=-elnx7e.",2020,Improvement was observed on all objective and QOL subjective parameters.,"['Registered 25 September 2019 - Retrospectively registered, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S00098SX&selectaction=Edit&uid=U0000W0Y&ts=51&cx=-elnx7e', '54 patients recruited with 35 available for follow up']","['laser tongue debridement (LTD) with an Er,Cr:YSGG solid state laser', 'LTD', 'Laser tongue debridement for oral malodor']","['objective and QOL subjective parameters', 'oral hygiene and reduces malodor']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1839730', 'cui_str': 'Prieto X-linked mental retardation syndrome'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C1289836', 'cui_str': 'Solid-state laser device'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",54.0,0.0383094,Improvement was observed on all objective and QOL subjective parameters.,"[{'ForeName': 'Yosef P', 'Initials': 'YP', 'LastName': 'Krespi', 'Affiliation': 'Northwell Health, United States of America. Electronic address: ykrespi1@northwell.edu.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Kizhner', 'Affiliation': ""Mount Sinai St. Luke's, United States of America.""}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Wilson', 'Affiliation': 'Northwell Health, United States of America.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Sivriver', 'Affiliation': 'Biolase, Irvine, CA, United States of America.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Low', 'Affiliation': 'Biolase, Irvine, CA, United States of America.'}, {'ForeName': 'Yalda', 'Initials': 'Y', 'LastName': 'Khosravi', 'Affiliation': 'Ohio State University, Campus Microscopy and Imaging Facility, Departments of Microbial Infection and Immunity and Orthopaedics, Infectious Diseases Institute, United States of America.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stoodley', 'Affiliation': 'Ohio State University, Campus Microscopy and Imaging Facility, Departments of Microbial Infection and Immunity and Orthopaedics, Infectious Diseases Institute, United States of America.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102458']
2269,33045627,Percutaneous pulsed radiofrequency treatment of dorsal root ganglion for treatment of lumbar facet syndrome.,"OBJECTIVES


Percutaneous radiofrequency denervation of the medial dorsal branch is often used for treatment of chronic low back pain originating from intervertebral facets, which is sometimes associated with a low success rate and a higher incidence of recurrence of pain. We theorized that implementing pulsed radiofrequency treatment to dorsal root ganglion would increase the probability of successful pain relief.
PATIENTS AND METHODS


150 patients diagnosed with CLBP of a confirmed facet origin were included in a prospective randomized controlled trial and were randomly divided into three equal groups, the first was submitted to percutaneous pulsed radiofrequency treatment of the dorsal root ganglia, the second underwent percutaneous radiofrequency denervation of the medial dorsal branch and the third was a control group that did not receive any radiofrequency treatment. Local injection of a mixture of local anesthetic and a steroid was given to the three groups. Cases were followed for a maximum of 3 years.
RESULTS


98 (65.3 %) patients were females. By 3 months' post procedure, improvement in VAS was significantly better than pretreatment levels in all groups (p= 0.026); the pulsed radiofrequency treatment group, however, had significantly better incidence of improvement when compared to the other two groups (p= 0.014).The control group lost improvement by 1-year follow-up (p=0.63). At 2 years' follow-up, the pulsed radiofrequency treatment of the dorsal root ganglia group maintained significant improvement (p= 0.041) whereas the medial branch denervation group lost its significant effect (p=0.32).By the end of follow-up period, only pulsed radiofrequency treatment of the dorsal root ganglia group kept significant improvement (p=0.044).
CONCLUSION


In CLBP of facet origin, pulsed radiofrequency treatment of the dorsal root ganglia provides both a higher incidence as well as an extended period of pain relief compared to radiofrequency ablation of the medial dorsal branch of the facet joint.",2020,"By 3 months' post procedure, improvement in VAS was significantly better than pretreatment levels in all groups (p= 0.026); the pulsed radiofrequency treatment group, however, had significantly better incidence of improvement when compared to the other two groups (p= 0.014).The control group lost improvement by 1-year follow-up (p=0.63).","['lumbar facet syndrome', '98 (65.3 %) patients were females', '150 patients diagnosed with CLBP of a confirmed facet origin']","['percutaneous pulsed radiofrequency treatment of the dorsal root ganglia, the second underwent percutaneous radiofrequency denervation of the medial dorsal branch and the third was a control group that did not receive any radiofrequency treatment', 'Percutaneous pulsed radiofrequency treatment of dorsal root ganglion', 'mixture of local anesthetic and a steroid']","['VAS', 'probability of successful pain relief']","[{'cui': 'C0458225', 'cui_str': 'Lumbar facet joint pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017070', 'cui_str': 'Structure of spinal nerve ganglion'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1740811', 'cui_str': 'Radiofrequency denervation'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",150.0,0.0175157,"By 3 months' post procedure, improvement in VAS was significantly better than pretreatment levels in all groups (p= 0.026); the pulsed radiofrequency treatment group, however, had significantly better incidence of improvement when compared to the other two groups (p= 0.014).The control group lost improvement by 1-year follow-up (p=0.63).","[{'ForeName': 'Wael Mohamed', 'Initials': 'WM', 'LastName': 'Moussa', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Alexandria University, EL Khartoum Square, Azarita, Alexandria, Egypt. Electronic address: waelmmosa@yahoo.com.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Khedr', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Alexandria University, EL Khartoum Square, Azarita, Alexandria, Egypt. Electronic address: waelkhedr2000@yahoo.com.'}, {'ForeName': 'Medhat', 'Initials': 'M', 'LastName': 'Elsawy', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, El Menia University, Korneesh El Nil, El Menia, Egypt. Electronic address: medhatelsawy73@yahoo.com.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106253']
2270,33045675,"A pilot study of the effects of chromium picolinate supplementation on serum fetuin-A, metabolic and inflammatory factors in patients with nonalcoholic fatty liver disease: A double-blind, placebo-controlled trial.","BACKGROUND


Evaluating the impact of chromium picolinate supplementation on glycemic status, lipid profile, inflammatory markers and fetuin-A in patients with non-alcoholic fatty liver disease (NAFLD).
METHODS


In present research, participants (N = 46) were randomized to (400 mcg/day, n = 23) chromium picolinate and placebo (n = 23) for 3 months.
RESULTS


Glucose indices, and lipid profiles, inflammatory biomarker and fetuin-A were measured before and after the intervention. Chromium reduced triglyceride (TG), atherogenic index of plasma (AIP), very-low-density lipoprotein (VLDL), insulin, homeostatic model assessment for insulin resistance (HOMA-IR), high-sensitivity C-reactive protein (hs-CRP), interleukin (IL) -6, tumor necrosis factor-alpha (TNF-α) and fetuin-A significantly compared to placebo group (p < 0.05). Furthermore, chromium significantly increased the quantitative insulin sensitivity check index (QUICKI). There were no significant differences in total cholesterol (TC), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), fasting blood sugar (FBS), Hemoglobin A1c (HbA1C), interleukin (IL)-17 between the two groups (p < 0.05).
CONCLUSION


Chromium picolinate significantly decreased TG, insulin, HOMA-IR, fetuin-A, the number of inflammatory factors, and increased QUICKI without changing FBS, HbA1C, TC, LDL, HDL, IL-17 levels and liver steatosis intensity in patients with NAFLD. Further studies by examining the effect of different doses of chromium and mechanisms of cellular action, would help further clarify the subject.",2020,"Furthermore, chromium significantly increased the quantitative insulin sensitivity check index (QUICKI).","['patients with NAFLD', 'patients with nonalcoholic fatty liver disease', 'participants (N\u202f=\u202f46', 'patients with non-alcoholic fatty liver disease (NAFLD']","['chromium picolinate and placebo', 'chromium picolinate supplementation', 'placebo', 'Chromium picolinate']","['serum fetuin-A, metabolic and inflammatory factors', 'Chromium reduced triglyceride (TG), atherogenic index of plasma (AIP), very-low-density lipoprotein (VLDL), insulin, homeostatic model assessment for insulin resistance (HOMA-IR), high-sensitivity C-reactive protein (hs-CRP), interleukin (IL) -6, tumor necrosis factor-alpha (TNF-α) and fetuin-A', 'quantitative insulin sensitivity check index (QUICKI', 'Glucose indices, and lipid profiles, inflammatory biomarker and fetuin-A', 'total cholesterol (TC), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), fasting blood sugar (FBS), Hemoglobin A1c (HbA1C), interleukin (IL)-17', 'glycemic status, lipid profile, inflammatory markers', 'TG, insulin, HOMA-IR, fetuin-A, the number of inflammatory factors, and increased QUICKI without changing FBS, HbA1C, TC, LDL, HDL, IL-17 levels and liver steatosis intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0163657', 'cui_str': 'CHROMIUM PICOLINATE'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C3160817', 'cui_str': 'Serum fetuin-A'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0051477', 'cui_str': 'Alpha>2< hS glycoprotein'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",46.0,0.22934,"Furthermore, chromium significantly increased the quantitative insulin sensitivity check index (QUICKI).","[{'ForeName': 'Fardin', 'Initials': 'F', 'LastName': 'Moradi', 'Affiliation': 'Student Research Committee, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran; Nutrition Research Center, Department of Biochemistry & Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Science, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Kooshki', 'Affiliation': 'Student Research Committee, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran; Nutrition Research Center, Department of Biochemistry & Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Science, Iran.'}, {'ForeName': 'Forough', 'Initials': 'F', 'LastName': 'Nokhostin', 'Affiliation': 'Assistant Professor of Internal Medicine, Dept. of Internal Medicine, Faculty of Medicine, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Manouchehr', 'Initials': 'M', 'LastName': 'Khoshbaten', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Bazyar', 'Affiliation': 'Student Research Committee, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Pourghassem Gargari', 'Affiliation': 'Nutrition Research Center, Department of Biochemistry & Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Science, Iran. Electronic address: pourghassemb@tbzmed.ac.ir.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126659']
2271,33045769,Effects of Intraoperative Ventilation Strategy on Perioperative Atelectasis Assessed by Lung Ultrasonography in Patients Undergoing Open Abdominal Surgery: a Prospective Randomized Controlled Study.,"BACKGROUND


Protective mechanical ventilation using low tidal volume has been introduced to surgical patients to reduce the incidence of postoperative pulmonary complications. We investigated the effects of protective ventilation (PV) techniques on anesthesia-induced atelectasis identified via lung ultrasonography in patients undergoing abdominal surgery.
METHODS


A total of 42 adult patients who were scheduled for open abdominal surgery with an expected duration > 2 hours were included in the study. Patients were randomized to receive either conventional ventilation (CV; tidal volume of 9-10 mL/kg predicted body weight [PBW] with no positive end-expiratory pressure [PEEP]) or PV (tidal volume of 6-8 mL/kg PBW and 5 cmH₂O PEEP) via pressure-controlled ventilation with volume guaranteed. Lung ultrasonography was performed at four predefined time points to assess perioperative atelectasis by dividing each hemithorax into six quadrants based on a modified lung ultrasound (LUS) scoring system.
RESULTS


The tidal volume delivered to patients was 9.65 ± 1.65 mL/kg PBW in the CV group and 6.31 ± 0.62 mL/kg PBW in the PV group. Ventilation using low tidal volume led to similar LUS scores in all lung areas and at all time points compared to ventilation using high tidal volume. There was no significant difference between the groups in the number of patients requiring recruitment maneuvers at the end of surgery.
CONCLUSION


Ventilation with low tidal volume combined with 5 cmH₂O PEEP did not cause further loss of aeration compared to ventilation with high tidal volume. Low tidal volume ventilation can be used in patients without lung injury based on lung assessment by bedside lung ultrasonography.
TRIAL REGISTRATION


Clinical Research Information Service Identifier: KCT0003746.",2020,Ventilation using low tidal volume led to similar LUS scores in all lung areas and at all time points compared to ventilation using high tidal volume.,"['Patients Undergoing Open Abdominal Surgery', '42 adult patients who were scheduled for open abdominal surgery with an expected duration > 2 hours were included in the study', 'patients undergoing abdominal surgery', 'patients without lung injury based on lung assessment by bedside lung ultrasonography']","['Ventilation with low tidal volume combined with 5 cmH₂O PEEP', 'protective ventilation (PV) techniques', 'Low tidal volume ventilation', 'conventional ventilation (CV; tidal volume of 9-10 mL/kg predicted body weight [PBW] with no positive end-expiratory pressure [PEEP]) or PV (tidal volume of 6-8 mL/kg PBW and 5 cmH₂O PEEP) via pressure-controlled ventilation with volume guaranteed', 'Lung Ultrasonography', 'Intraoperative Ventilation Strategy', 'Lung ultrasonography']","['number of patients requiring recruitment maneuvers', 'LUS scores', 'tidal volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0203463', 'cui_str': 'Ultrasonography of lung'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0203463', 'cui_str': 'Ultrasonography of lung'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}]",42.0,0.0805521,Ventilation using low tidal volume led to similar LUS scores in all lung areas and at all time points compared to ventilation using high tidal volume.,"[{'ForeName': 'Sooyoung', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ewha Womans University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Hye Won', 'Initials': 'HW', 'LastName': 'Oh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ewha Womans University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Min Hee', 'Initials': 'MH', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ewha Womans University Mokdong Hospital, Seoul, Korea.'}, {'ForeName': 'Hyun Jung', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ewha Womans University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae Hee', 'Initials': 'JH', 'LastName': 'Woo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ewha Womans University, School of Medicine, Seoul, Korea.'}]",Journal of Korean medical science,['10.3346/jkms.2020.35.e327']
2272,33046009,Feasibility of a yoga intervention to decrease pain in older women: a randomized controlled pilot study.,"BACKGROUND


A significant proportion of older women suffer from chronic pain, which can decrease quality of life. The objective of this pilot randomized study was to evaluate the feasibility of a flow-restorative yoga intervention designed to decrease pain and related outcomes among women aged 60 or older.
METHODS


Flow-restorative yoga classes were held twice weekly for 1 hour and led by a certified yoga instructor. Participants randomized to the intervention group attended the yoga classes for 12 weeks and received supplemental materials for at-home practice. Those randomized to the control group were asked to maintain their normal daily routine. Feasibility was evaluated using recruitment and retention rates, class and home practice adherence rates, and participant satisfaction surveys. Outcome measures (self-reported pain, inflammatory markers, functional fitness, quality of life, resilience, and self-reported physical activity) were assessed at baseline and post-intervention. Paired t-tests or Wilcoxon signed-rank tests were used to examine changes in outcome measures within treatment groups.
RESULTS


Thirty-eight participants were recruited and randomized. Participants were primarily white, college-educated, and higher functioning, despite experiencing various forms of chronic pain. Attendance and retention rates were high (91 and 97%, respectively) and the majority of participants were satisfied with the yoga program (89%) and would recommend it to others (87%). Intervention participants also experienced reductions in pain interference and improvements in energy and social functioning.
CONCLUSIONS


This pilot study provides essential data to inform a full scale randomized trial of flow-restorative yoga for older women with chronic pain. Future studies should emphasize strategies to recruit a more diverse study population, particularly older women at higher risk of disability and functional decline.
TRIAL REGISTRATION


Clinicaltrials.gov , NCT03790098 . Registered 31 December 2018 - Retrospectively registered.",2020,"Attendance and retention rates were high (91 and 97%, respectively) and the majority of participants were satisfied with the yoga program (89%) and would recommend it to others (87%).","['older women suffer from chronic pain', 'older women', 'women aged 60 or older', 'Participants were primarily white, college-educated, and higher functioning, despite experiencing various forms of chronic pain', 'Thirty-eight participants were recruited and randomized', 'older women with chronic pain', 'Registered 31 December 2018 - Retrospectively registered']","['flow-restorative yoga intervention', 'flow-restorative yoga', 'yoga intervention']","['pain interference and improvements in energy and social functioning', 'recruitment and retention rates, class and home practice adherence rates, and participant satisfaction surveys', 'Outcome measures (self-reported pain, inflammatory markers, functional fitness, quality of life, resilience, and self-reported physical activity', 'Attendance and retention rates', 'pain']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",38.0,0.162826,"Attendance and retention rates were high (91 and 97%, respectively) and the majority of participants were satisfied with the yoga program (89%) and would recommend it to others (87%).","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Seguin-Fowler', 'Affiliation': 'Texas A&M AgriLife Research, 600 John Kimborough Boulevard, Suite 512, College Station, TX, USA. r.seguin-fowler@ag.tamu.edu.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Graham', 'Affiliation': 'Texas A&M University System, 600 John Kimborough Boulevard, Suite 512, College Station, TX, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Ward', 'Affiliation': 'Cornell University, 413 Savage Hall, Ithaca, NY, 14853, USA.'}, {'ForeName': 'Galen', 'Initials': 'G', 'LastName': 'Eldridge', 'Affiliation': 'Texas A&M AgriLife Research, 600 John Kimborough Boulevard, Suite 512, College Station, TX, USA.'}, {'ForeName': 'Urshila', 'Initials': 'U', 'LastName': 'Sriram', 'Affiliation': 'Texas A&M AgriLife Research, 600 John Kimborough Boulevard, Suite 512, College Station, TX, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Fine', 'Affiliation': 'Fine Spirit Yoga, 104 E. Lewis St, Ithaca, NY, 14850, USA.'}]",BMC geriatrics,['10.1186/s12877-020-01818-y']
2273,33046026,"Study protocol: parents as pain management in Swedish neonatal care - SWEpap, a multi-center randomized controlled trial.","BACKGROUND


During the first period of life, critically ill as well as healthy newborn infants experience recurrent painful procedures. Parents are a valuable but often overlooked resource in procedural pain management in newborns. Interventions to improve parents' knowledge and involvement in infants' pain management are essential to implement in the care of the newborn infant. Neonatal pain research has studied a range of non-pharmacological pain alleviating strategies during painful procedures, yet, regarding combined multisensorial parent-driven non-pharmacological pain management, research is still lacking.
METHODS/DESIGN


A multi-center randomized controlled trial (RCT) with three parallel groups with the allocation ratio 1:1:1 is planned. The RCT ""Parents as pain management in Swedish neonatal care - SWEpap"", will investigate the efficacy of combined pain management with skin-to-skin contact, breastfeeding and live parental lullaby singing compared with standard pain care initiated by health care professionals, during routine metabolic screening of newborn infants (PKU-test).
DISCUSSION


Parental involvement in neonatal pain management enables a range of comforting parental interventions such as skin-to-skin contact, breastfeeding, rocking and soothing vocalizations. To date, few studies have been published examining the efficacy of combined multisensorial parent-driven interventions. So far, research shows that the use of combined parent-driven pain management such as skin-to-skin contact and breastfeeding, is more effective in reducing behavioral responses to pain in infants, than using the pain-relieving interventions alone. Combined parental soothing behaviors that provide rhythmic (holding/rocking/vocalizing) or orogustatory/orotactile (feeding/pacifying) stimulation that keep the parent close to the infant, are more effective in a painful context. In the SWEpap study we also include parental live lullaby singing, which is an unexplored but promising biopsychosocial, multimodal and multisensory pain alleviating adjuvant, especially in combination with skin-to-skin contact and breastfeeding.
TRIAL REGISTRATION


ClinicalTrials.gov ( NCT04341194 ) 10 April 2020.",2020,Interventions to improve parents' knowledge and involvement in infants' pain management are essential to implement in the care of the newborn infant.,"['newborns', 'healthy newborn infants experience recurrent painful procedures']",['Combined parental soothing behaviors that provide rhythmic (holding/rocking/vocalizing) or orogustatory/orotactile (feeding/pacifying) stimulation'],[],"[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0578757', 'cui_str': 'Good neonatal condition at birth'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005899', 'cui_str': 'Repetitive rocking movements'}, {'cui': 'C0564182', 'cui_str': 'Vocalization'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",[],,0.0632619,Interventions to improve parents' knowledge and involvement in infants' pain management are essential to implement in the care of the newborn infant.,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Olsson', 'Affiliation': 'Faculty of Medicine and Health, School of Health Sciences, Örebro University, S-701 82, Örebro, Sweden. emma.olsson@oru.se.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Carlsen Misic', 'Affiliation': 'Faculty of Medicine and Health, School of Health Sciences, Örebro University, S-701 82, Örebro, Sweden.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Dovland Andersen', 'Affiliation': 'Department of Research, Telemark Hospital Trust, Skien, Norway.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ericson', 'Affiliation': 'School of Education, Health and Social Studies, Dalarna University, Falun, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Eriksson', 'Affiliation': 'Faculty of Medicine and Health, School of Health Sciences, Örebro University, S-701 82, Örebro, Sweden.'}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Thernström Blomqvist', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Ullsten', 'Affiliation': 'Faculty of Medicine and Health, School of Health Sciences, Örebro University, S-701 82, Örebro, Sweden.'}]",BMC pediatrics,['10.1186/s12887-020-02356-7']
2274,33046053,Bone turnover biomarkers in COPD patients randomized to either a regular or shortened course of corticosteroids: a substudy of the randomized controlled CORTICO-COP trial.,"BACKGROUND


Long-term treatment with corticosteroids causes loss of bone density, but the effects of using short-term high-dose systemic-corticosteroid therapy to treat acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are unclear. Our aim was to determine whether high-dose corticosteroid therapy affected bone turnover markers (BTMs) to a greater extent compared to low-dose corticosteroid therapy.
METHODS


The CORTICO-COP trial (NCT02857842) showed that an eosinophil-guided corticosteroid intervention led to approximately 60% lower accumulated corticosteroid dose for hospitalized patients with AECOPD (low-dose group) compared with 5-day standard corticosteroid treatment (high-dose group). We compared the levels of BTMs C-terminal telopeptide of type 1 collagen (CTX) and procollagen type 1 N-terminal propeptide (P1NP) in 318 participants during AECOPD and at 1- and 3-month follow-up visits.
RESULTS


CTX decreased and P1NP increased significantly over time in both treatment groups. There were no significant differences between the groups at 1- or 3-months follow-up for P1NP. A significant drop in CTX was seen at 3 months (down Δ24% from the baseline, p = 0.017) for the high dose group.
CONCLUSION


Short-term, high-dose systemic corticosteroid treatment caused a rapid suppression of biomarkers of bone resorption. Corticosteroids did not suppress biomarkers of bone formation, regardless of patients receiving low or high doses of corticosteroids. This therapy was, therefore, harmless in terms of bone safety, in our prospective series of COPD patients.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02857842 . Submitted August 2nd, 2016.",2020,"A significant drop in CTX was seen at 3 months (down Δ24% from the baseline, p = 0.017) for the high dose group.
","['318 participants during AECOPD and at 1- and 3-month follow-up visits', 'COPD patients']","['corticosteroids', 'Corticosteroids']","['CTX', 'levels of BTMs C-terminal telopeptide of type 1 collagen (CTX) and procollagen type 1\u2009N-terminal propeptide (P1NP', 'rapid suppression of biomarkers of bone resorption', 'bone formation', 'Bone turnover biomarkers', 'P1NP', 'bone turnover markers (BTMs']","[{'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]",,0.319295,"A significant drop in CTX was seen at 3 months (down Δ24% from the baseline, p = 0.017) for the high dose group.
","[{'ForeName': 'Pradeesh', 'Initials': 'P', 'LastName': 'Sivapalan', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, Ground Floor, DK-2900, Hellerup, Denmark. pradeesh.s@dadlnet.dk.'}, {'ForeName': 'Niklas R', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Biochemistry, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Mathioudakis', 'Affiliation': 'The North West Lung Centre, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Josefin', 'Initials': 'J', 'LastName': 'Eklöf', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, Ground Floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Lapperre', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte Suppli', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Helle F', 'Initials': 'HF', 'LastName': 'Andreassen', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Armbruster', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, Ground Floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Praleene', 'Initials': 'P', 'LastName': 'Sivapalan', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, Ground Floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Janner', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Godtfredsen', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ulla M', 'Initials': 'UM', 'LastName': 'Weinreich', 'Affiliation': 'Department of Respiratory Diseases, Aalborg University Hospital, Aalborg, Denmark; The Clinical Institute, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Thyge L', 'Initials': 'TL', 'LastName': 'Nielsen', 'Affiliation': 'Department of Respiratory and Infectious Diseases, Frederiksund and Hillerød Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Seersholm', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, Ground Floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Torgny', 'Initials': 'T', 'LastName': 'Wilcke', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, Ground Floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'Medical University Department, Kantonsspital Aarau, 5001, Aarau, Switzerland.'}, {'ForeName': 'Tobias W', 'Initials': 'TW', 'LastName': 'Klausen', 'Affiliation': 'Clinical Research Unit, Department of Hematology, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Marså', 'Affiliation': 'Palliative Medicine Section Unit, Herlev and Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Vestbo', 'Affiliation': 'The North West Lung Centre, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Jens-Ulrik', 'Initials': 'JU', 'LastName': 'Jensen', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, Ground Floor, DK-2900, Hellerup, Denmark.'}]",Respiratory research,['10.1186/s12931-020-01531-9']
2275,33046070,Blood pressure and mortality in patients with type 2 diabetes and a recent coronary event in the ELIXA trial.,"BACKGROUND


The relationship between blood pressure and mortality in type 2 diabetes (T2DM) is controversial, with concern for increased risk associated with excessively lowered blood pressure.
METHODS


We evaluated whether prior cardiovascular disease (CVD) altered the relationship between baseline blood pressure and all-cause mortality in 5852 patients with T2DM and a recent acute coronary syndrome (ACS) who participated in the ELIXA (Evaluation of Lixisenatide in Acute Coronary Syndrome) trial. Risk of death was assessed in Cox models adjusted for age, sex, race, heart rate, BMI, smoking, diabetes duration, insulin use, HbA1c, eGFR, brain natriuretic peptide (BNP), urine albumin/creatinine ratio, treatment allocation and prior coronary revascularization.
RESULTS


Although overall there was no significant association between systolic blood pressure (SBP) and mortality (hazard ratio per 10 mmHg lower SBP 1.05 (95% CI 0.99-1.12) P = 0.10), lower SBP was significantly associated with higher risk of death (hazard ratio per 10 mmHg lower SBP 1.13 (95% CI 1.04-1.22) P = 0.002) in 2325 patients with additional CVD (index ACS+ at least one of the following prior to randomization: myocardial infarction other than the index ACS, stroke or heart failure). In 3527 patients with only the index ACS no significant association was observed (hazard ratio per 10 mmHg lower SBP 0.95 (0.86-1.04) P = 0.26; P for interaction 0.005).
CONCLUSIONS


The association between blood pressure and mortality was modified by additional CVD history in patients with type 2 diabetes and a recent coronary event. When blood pressures measured after an acute coronary event are used to assess the risk of death in patients with type 2 diabetes, the cardiovascular history needs to be taken into consideration. Trial registration ClinicalTrials.gov number NCT01147250, first posted June 22, 2010.",2020,"Although overall there was no significant association between systolic blood pressure (SBP) and mortality (hazard ratio per 10 mmHg lower SBP 1.05 (95% CI 0.99-1.12) P = 0.10), lower SBP was significantly associated with higher risk of death (hazard ratio per 10 ","['patients with type 2 diabetes and a recent coronary event', 'patients with type 2 diabetes and a recent coronary event in the ELIXA trial', 'patients with type 2 diabetes', '2325 patients with additional CVD (index ACS+\u2009at least one of the following prior to randomization: myocardial infarction other than the index ACS, stroke or heart failure', '5852 patients with T2DM and a recent acute coronary syndrome (ACS) who participated in the ELIXA (Evaluation of Lixisenatide in Acute Coronary Syndrome) trial']",[],"['blood pressure and mortality', 'risk of death', 'Risk of death', 'lower SBP', 'systolic blood pressure (SBP) and mortality', 'heart rate, BMI, smoking, diabetes duration, insulin use, HbA1c, eGFR, brain natriuretic peptide (BNP), urine albumin/creatinine ratio, treatment allocation and prior coronary revascularization', 'Blood pressure and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0277885', 'cui_str': 'Decreased systolic arterial pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0455271', 'cui_str': 'Urine albumin/creatinine ratio measurement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]",2325.0,0.0660196,"Although overall there was no significant association between systolic blood pressure (SBP) and mortality (hazard ratio per 10 mmHg lower SBP 1.05 (95% CI 0.99-1.12) P = 0.10), lower SBP was significantly associated with higher risk of death (hazard ratio per 10 ","[{'ForeName': 'Magnus O', 'Initials': 'MO', 'LastName': 'Wijkman', 'Affiliation': ""Cardiovascular Division, Brigham & Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA. mwijkman@bwh.harvard.edu.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham & Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA.""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina.'}, {'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'The Population Health Research Institute and the Department of Medicine, McMaster University and Hamilton Health Sciences, Hamilton, Canada.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Eldrin', 'Initials': 'E', 'LastName': 'Lewis', 'Affiliation': 'Stanford University Medical Center, Stanford, USA.'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'Maria Cecilia Hospital, GVM Care & Research, Cotignola, Italy.'}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Wolsk', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Aguilar', 'Affiliation': 'McGovern Medical School, University of Texas, Houston, USA.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Bentley-Lewis', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Probstfield', 'Affiliation': 'University of Washington Medical Center, Seattle, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Riddle', 'Affiliation': 'Oregon Health and Science University, Portland, USA.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham & Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA.""}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Cardiovascular Division, Brigham & Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA.""}]",Cardiovascular diabetology,['10.1186/s12933-020-01150-0']
2276,33046136,The Janus kinase 1/2 inhibitor baricitinib reduces biomarkers of joint destruction in moderate to severe rheumatoid arthritis.,"BACKGROUND


Tissue released blood-based biomarkers can provide insight into drug mode of action and response. To understand the changes in extracellular matrix turnover, we analyzed biomarkers associated with joint tissue turnover from a phase 3, randomized, placebo-controlled study of baricitinib in patients with active rheumatoid arthritis (RA).
METHODS


Serum biomarkers associated with synovial inflammation (C1M, C3M, and C4M), cartilage degradation (C2M), bone resorption (CTX-I), and bone formation (osteocalcin) were analyzed at baseline, and weeks 4 and 12, from a subgroup of patients (n = 240) randomized to placebo or 2-mg or 4-mg baricitinib (RA-BUILD, NCT01721057). Mixed-model repeated measure was used to identify biomarkers altered by baricitinib. The relationship between changes in biomarkers and clinical measures was evaluated using correlation analysis.
RESULTS


Treatment arms were well balanced for baseline biomarkers, demographics, and disease activity. At week 4, baricitinib 4-mg significantly reduced C1M from baseline by 21% compared to placebo (p < 0.01); suppression was sustained at week 12 (27%, p < 0.001). Baricitinib 4-mg reduced C3M and C4M at week 4 by 14% and 12% compared to placebo, respectively (p < 0.001); they remained reduced by 16% and 11% at week 12 (p < 0.001). In a pooled analysis including all treatment arms, patients with the largest reduction (upper 25% quartile) in C1M, C3M, and C4M by week 12 had significantly greater clinical improvement in the Simplified Disease Activity Index at week 12 compared to patients with the smallest reduction (lowest 25% quartile).
CONCLUSION


Baricitinib treatment resulted in reduced circulating biomarkers associated with joint tissue destruction as well as concomitant RA clinical improvement.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01721057 ; date of registration: November 1, 2012.",2020,"At week 4, baricitinib 4-mg significantly reduced C1M from baseline by 21% compared to placebo (p < 0.01); suppression was sustained at week 12 (27%, p < 0.001).",['patients with active rheumatoid arthritis (RA'],['placebo'],"['C1M', 'baseline biomarkers, demographics, and disease activity', 'C3M and C4M', 'Simplified Disease Activity Index', 'synovial inflammation (C1M, C3M, and C4M), cartilage degradation (C2M), bone resorption (CTX-I), and bone formation (osteocalcin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}]",,0.163022,"At week 4, baricitinib 4-mg significantly reduced C1M from baseline by 21% compared to placebo (p < 0.01); suppression was sustained at week 12 (27%, p < 0.001).","[{'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Thudium', 'Affiliation': 'Nordic Bioscience, Biomarkers and Research, Herlev Hovedgade 205-207, DK-2730, Herlev, Denmark. cst@nordicbio.com.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Bay-Jensen', 'Affiliation': 'Nordic Bioscience, Biomarkers and Research, Herlev Hovedgade 205-207, DK-2730, Herlev, Denmark.'}, {'ForeName': 'Suntara', 'Initials': 'S', 'LastName': 'Cahya', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Ernst R', 'Initials': 'ER', 'LastName': 'Dow', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Morten A', 'Initials': 'MA', 'LastName': 'Karsdal', 'Affiliation': 'Nordic Bioscience, Biomarkers and Research, Herlev Hovedgade 205-207, DK-2730, Herlev, Denmark.'}, {'ForeName': 'Alisa E', 'Initials': 'AE', 'LastName': 'Koch', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Wenling', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Benschop', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}]",Arthritis research & therapy,['10.1186/s13075-020-02340-7']
2277,33046141,A novel omega-3 glyceride mixture enhances enrichment of eicosapentaenoic acid and docosahexaenoic acid after single dosing in healthy older adults: results from a double-blind crossover trial.,"A glyceride mix of mono, di, and triglycerides increases solubilisation and enhances emulsification of omega-3 (ω-3) fatty acid (FA) containing lipids in the stomach. This allows for better access of digestive enzymes, pivotal for the release of bioactive ω-3 FA.The objective was to compare the effect of a glyceride formulation and an ethyl ester (EE) formulation of EPA+DHA on concentrations of EPA and DHA in plasma following single dosing.We conducted a double-blind crossover trial in which twenty healthy adults aged 50-70 y consumed a single dose (2.8 g EPA+DHA) of each EPA+DHA formulation without a meal in random order separated by a two-week wash out period. EPA and DHA were measured in plasma total lipid over the following 12 h.EPA and DHA in plasma total lipid increased over 12 h with both formulations. A 10 x greater Δ concentration of EPA, 3 x greater Δ concentration of DHA, and 5 x greater Δ concentration of EPA+DHA was seen with the glyceride-EPA+DHA. The time at which the maximal concentrations of ω-3 FA occurred was 4 h earlier for EPA, 1 h earlier for DHA, and 2 h earlier for EPA+DHA when consuming glyceride-EPA+DHA.A mix of mono, di, and triglycerides results in greater and faster incorporation of EPA and DHA into blood plasma lipid in the absence of a fatty meal. This may provide benefit to individuals on a low fat diet or with digestive impairments and could result in greater efficacy in clinical trials using ω-3 FA.",2020,"A glyceride mix of mono, di, and triglycerides increases solubilisation and enhances emulsification of omega-3 (ω-3) fatty acid (FA) containing lipids in the stomach.","['twenty healthy adults aged 50-70 y consumed a single dose (2.8 g EPA+DHA) of each', 'healthy older adults']","['glyceride formulation and an ethyl ester (EE) formulation of EPA+DHA', 'EPA+DHA formulation', 'eicosapentaenoic acid and docosahexaenoic acid']","['maximal concentrations of ω-3 FA', 'concentrations of EPA and DHA in plasma', 'EPA and DHA', 'plasma total lipid', 'EPA and DHA in plasma total lipid']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0017860', 'cui_str': 'Acylglycerols'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0523744', 'cui_str': 'Lipids measurement'}]",20.0,0.284585,"A glyceride mix of mono, di, and triglycerides increases solubilisation and enhances emulsification of omega-3 (ω-3) fatty acid (FA) containing lipids in the stomach.","[{'ForeName': 'Helena L', 'Initials': 'HL', 'LastName': 'Fisk', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, United Kingdom.'}, {'ForeName': 'Grete Mørk', 'Initials': 'GM', 'LastName': 'Kindberg', 'Affiliation': 'BASF Norge AS, 0283Oslo, Norway.'}, {'ForeName': 'Svein Olaf', 'Initials': 'SO', 'LastName': 'Hustvedt', 'Affiliation': 'BASF Norge AS, 0283Oslo, Norway.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, United Kingdom.'}]",The British journal of nutrition,['10.1017/S0007114520004031']
2278,33046199,[Antibiotics should not be used for treating back pain due to Modic changes].,"Infection has been proposed as a cause of back pain in individuals with Modic changes. This review summarises the knowledge on this topic in Scandinavia. A Norwegian randomized controlled trial could not replicate results in favor of antibiotic treatment for such patients. A Danish study demonstrated that patients with low back pain and Modic changes had similar physical disability-scores and less sick leave due to back pain than individuals without Modic changes at long-term follow-up (>10 years). A Swedish study displayed equal bacterial presence in discs of patients operated for lumbar disc herniation and in control patients, indicating that the presence of bacteria is caused by contamination during the surgical procedure and is not related to back pain.",2020,A Danish study demonstrated that patients with low back pain and Modic changes had similar physical disability-scores and less sick leave due to back pain than individuals without Modic changes at long-term follow-up (>10 years).,['individuals with Modic changes'],[],['physical disability-scores'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",[],"[{'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0387427,A Danish study demonstrated that patients with low back pain and Modic changes had similar physical disability-scores and less sick leave due to back pain than individuals without Modic changes at long-term follow-up (>10 years).,"[{'ForeName': 'Peter Muhareb', 'Initials': 'PM', 'LastName': 'Udby', 'Affiliation': 'peterudby@gmail.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fritzell', 'Affiliation': ''}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Bergström', 'Affiliation': ''}, {'ForeName': 'Bodil', 'Initials': 'B', 'LastName': 'Jönsson', 'Affiliation': ''}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Skorpil', 'Affiliation': ''}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Hägg', 'Affiliation': ''}, {'ForeName': 'Mikkel Østerheden', 'Initials': 'MØ', 'LastName': 'Andersen', 'Affiliation': ''}]",Ugeskrift for laeger,[]
2279,33046209,Using the Danish National Evaluation as a tool to measure patient-perceived drug information.,"INTRODUCTION


In 2017, as part of the Danish National Evaluation (LUP), some patients at Lillebaelt Hospital reported receiving insufficient information about their drug treatment. The aim of this study was to evaluate the effect of a multifaceted clinical pharmacist intervention on patient-reported levels of drug information received and patients' perceptions of safety and comfortability with their drug treatment.
METHODS


In this feasibility study, the intervention consisted of a multifaceted service including two patient interviews using a motivational interviewing approach. The interviews were held during admission and after discharge as a follow-up phone call. Patients were asked questions similar to those used in the LUP about the level of information they had received, and they self-evaluated their safety and comfortability with their drug treatment.
RESULTS


A total of 157 patients received the intervention; 135 patients were eligible for follow-up. Approximately 60% of the patients responded that the intervention had positively affected their feelings of safety and comfortability with their drug treatment. There was no significant difference in the patients' responses to the LUP questions regarding the level of information they had received before and after the intervention.
CONCLUSIONS


The intervention improved the majority of the patients' perceptions of safety and comfortability with their drug treatment. Although all patients received information about their drug treatment and their questions were answered, this was not reflected in their responses to the LUP questions.
FUNDING


The Development Council of Lillebaelt Hospital.
TRIAL REGISTRATION


The study was approved by the Danish Data Protection Agency.",2020,"There was no significant difference in the patients' responses to the LUP questions regarding the level of information they had received before and after the intervention.
",['157 patients received the intervention; 135 patients were eligible for follow-up'],"['motivational interviewing approach', 'multifaceted clinical pharmacist intervention']","['feelings of safety and comfortability', ""majority of the patients' perceptions of safety and comfortability""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1449564', 'cui_str': 'Clinical pharmacist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",135.0,0.041786,"There was no significant difference in the patients' responses to the LUP questions regarding the level of information they had received before and after the intervention.
","[{'ForeName': 'Lilian Brondgaard', 'Initials': 'LB', 'LastName': 'Nielsen', 'Affiliation': 'Lilian.brondgaard.nielsen@rsyd.dk.'}, {'ForeName': 'Majbritt Grabas', 'Initials': 'MG', 'LastName': 'Kruse', 'Affiliation': ''}, {'ForeName': 'Cecilia Holm', 'Initials': 'CH', 'LastName': 'Hansen', 'Affiliation': ''}, {'ForeName': 'Louise Smed', 'Initials': 'LS', 'LastName': 'Grønkjær', 'Affiliation': ''}, {'ForeName': 'Ejler', 'Initials': 'E', 'LastName': 'Ejlersen', 'Affiliation': ''}]",Danish medical journal,[]
2280,33046213,Dopaminergic and opioidergic regulation during anticipation and consumption of social and nonsocial rewards.,"The observation of animal orofacial and behavioral reactions has played a fundamental role in research on reward but is seldom assessed in humans. Healthy volunteers (N = 131) received 400 mg of the dopaminergic antagonist amisulpride, 50 mg of the opioidergic antagonist naltrexone, or placebo. Subjective ratings, physical effort, and facial reactions to matched primary social (affective touch) and nonsocial (food) rewards were assessed. Both drugs resulted in lower physical effort and greater negative facial reactions during reward anticipation, especially of food rewards. Only opioidergic manipulation through naltrexone led to a reduction in positive facial reactions to liked rewards during reward consumption. Subjective ratings of wanting and liking were not modulated by either drug. Results suggest that facial reactions during anticipated and experienced pleasure rely on partly different neurochemical systems, and also that the neurochemical bases for food and touch rewards are not identical.",2020,Only opioidergic manipulation through naltrexone led to a reduction in positive facial reactions to liked rewards during reward consumption.,['Healthy volunteers (N = 131'],"['dopaminergic antagonist amisulpride, 50 mg of the opioidergic antagonist naltrexone, or placebo', 'naltrexone']","['Subjective ratings, physical effort, and facial reactions to matched primary social (affective touch) and nonsocial (food) rewards', 'positive facial reactions', 'Subjective ratings of wanting and liking', 'lower physical effort and greater negative facial reactions']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0242702', 'cui_str': 'Dopamine receptor antagonist'}, {'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0031807', 'cui_str': 'Physical Effort'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.0526814,Only opioidergic manipulation through naltrexone led to a reduction in positive facial reactions to liked rewards during reward consumption.,"[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Korb', 'Affiliation': 'Department of Psychology, University of Essex, Colchester, United Kingdom.'}, {'ForeName': 'Sebastian J', 'Initials': 'SJ', 'LastName': 'Götzendorfer', 'Affiliation': 'Department of Cognition, Emotion and Methods in Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Massaccesi', 'Affiliation': 'Department of Clinical and Health Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Sezen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Graf', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Matthäus', 'Initials': 'M', 'LastName': 'Willeit', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Eisenegger', 'Affiliation': 'Department of Cognition, Emotion and Methods in Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Silani', 'Affiliation': 'Department of Clinical and Health Psychology, University of Vienna, Vienna, Austria.'}]",eLife,['10.7554/eLife.55797']
2281,33046233,Ventricular reshaping with a beating heart implant improves pump function in experimental heart failure.,"OBJECTIVE


The left ventricle remodels from an ellipsoidal/conical shape to a spherical shape after a myocardial infarction. The spherical ventricle is inefficient as a pumping chamber, has higher wall stresses, and can lead to congestive heart failure. We sought to investigate if restoring physiological ventricular shape with a beating heart implant improves pump function.
METHODS


Rats were induced with a myocardial infarction, developing left ventricular dilatation and dysfunction, and becoming spherical over 3 weeks. Thereafter, they were randomized to undergo left ventricular reshaping with a beating heart implant (n = 19) or continue follow-up without an implant (n = 19). Biweekly echocardiography was performed until 12 weeks, with half the rats euthanized at 6 weeks and remaining at 12 weeks. At termination, invasive hemodynamic parameters and histopathology were performed.
RESULTS


At 3 weeks after the infarction, rats had a 22% fall in ejection fraction, 31% rise in end diastolic volume, and 23% rise in sphericity. Transventricular implant reshaping reduced the volume by 12.6% and sphericity by 21%, restoring physiologic ventricular shape and wall stress. Over the 12-week follow-up, pump function improved significantly with better ventricular-vascular coupling in the reshaped hearts. In this group, cardiomyocyte cross-section area was higher and the cells were less elongated.
CONCLUSIONS


Reshaping a postinfarction, failing left ventricle to restore its physiological conical shape significantly improves long-term pump function.",2020,"Over the 12-week follow-up, pump function improved significantly with better ventricular-vascular coupling in the reshaped hearts.","['experimental heart failure', 'Rats were induced with a myocardial infarction, developing left ventricular dilatation and dysfunction, and becoming spherical over 3 weeks']","['left ventricular reshaping with a beating heart implant (n\xa0=\xa019) or continue follow-up without an implant', 'Ventricular reshaping with a beating heart implant']","['sphericity', 'cardiomyocyte cross-section area', 'ejection fraction', 'restoring physiologic ventricular shape and wall stress', 'end diastolic volume']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0344911', 'cui_str': 'Left cardiac ventricular dilatation'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0225828', 'cui_str': 'Cardiac myocyte'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0212346,"Over the 12-week follow-up, pump function improved significantly with better ventricular-vascular coupling in the reshaped hearts.","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Onohara', 'Affiliation': 'Structural Heart Research & Innovation Laboratory, Carlyle Fraser Heart Center, Emory University Hospital Midtown, Atlanta, Ga.'}, {'ForeName': 'Daniella M', 'Initials': 'DM', 'LastName': 'Corporan', 'Affiliation': 'Structural Heart Research & Innovation Laboratory, Carlyle Fraser Heart Center, Emory University Hospital Midtown, Atlanta, Ga.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Kono', 'Affiliation': 'Structural Heart Research & Innovation Laboratory, Carlyle Fraser Heart Center, Emory University Hospital Midtown, Atlanta, Ga.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Joint Department of Biomedical Engineering, Emory University/Georgia Institute of Technology, Atlanta, Ga.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Guyton', 'Affiliation': 'Structural Heart Research & Innovation Laboratory, Carlyle Fraser Heart Center, Emory University Hospital Midtown, Atlanta, Ga; Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine, Atlanta, Ga.'}, {'ForeName': 'Muralidhar', 'Initials': 'M', 'LastName': 'Padala', 'Affiliation': 'Structural Heart Research & Innovation Laboratory, Carlyle Fraser Heart Center, Emory University Hospital Midtown, Atlanta, Ga; Joint Department of Biomedical Engineering, Emory University/Georgia Institute of Technology, Atlanta, Ga; Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine, Atlanta, Ga. Electronic address: spadala@emory.edu.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2020.08.097']
2282,33046320,Quick cuts: A comparative study of two tools for ring tourniquet removal.,"BACKGROUND


Ring tourniquet occurs when a ring becomes entrapped due to swelling or trauma. As the finger expands the blood flow restriction causes additional swelling, which can lead to nerve damage and other complications. Ring tourniquet can be an emergency that requires rapid ring removal. Standard devices for ring removal have been described but rarely tested. We conducted a randomized study to compare removal time, user and participant satisfaction and complications between a motorized diamond disc ring cutter (MDDRC) and a ring cutter attached to trauma shears (TS).
METHODS


In pairs, emergency medicine providers removed rings using both devices and wore randomized rings to be removed (silver or steel). Each effort was timed from initiation to removal. After each effort both user and subject rated their satisfaction with the device, using a visual analog scale and reported any complications. Median and interquartile ranges were generated for the primary and secondary outcomes with 95% confidence intervals where applicable. Wilcoxon Rank Sum tests were calculated with a = 0.05 to compare removal time and secondary outcomes between the two tools.
RESULTS


Thirty subjects completed the study. Median time to ring removal was significantly lower with the TS compared to the MDDRC (7.7 vs 67.0 s, p < .0001). Device user satisfaction (9.7/10 vs 3.8/10, p < .0001) and participant satisfaction (9.7/10 vs 6.8/10, p < .0001) were significantly higher with the TS, while participant discomfort was significantly lower with the TS (0.0/10 vs 2.2/10, p < .0001).
CONCLUSION


This study is the first to compare efficacy, satisfaction and complications of two standard tools for removal of ring tourniquets. The TS took significantly less time than the GEM MDDRC and demonstrated significantly better satisfaction for both the ring wearer and ring remover.",2020,The TS took significantly less time than the GEM MDDRC and demonstrated significantly better satisfaction for both the ring wearer and ring remover.,['Thirty subjects completed the study'],['motorized diamond disc ring cutter (MDDRC) and a ring cutter attached to trauma shears (TS'],"['Wilcoxon Rank Sum tests', 'Median and interquartile ranges', 'Median time to ring removal', 'participant satisfaction', 'Device user satisfaction', 'participant discomfort', 'efficacy, satisfaction and complications']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0180263', 'cui_str': 'Ring cutter'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}]","[{'cui': 'C0242928', 'cui_str': 'Rank-Sum Tests'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.129552,The TS took significantly less time than the GEM MDDRC and demonstrated significantly better satisfaction for both the ring wearer and ring remover.,"[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Walter', 'Affiliation': 'Regions Hospital and HealthPartners, St. Paul, MN, United States of America; Critical Care Research Center, St. Paul, MN, United States of America. Electronic address: joseph.w.walter@healthpartners.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'DeBoer', 'Affiliation': 'Regions Hospital and HealthPartners, St. Paul, MN, United States of America; Critical Care Research Center, St. Paul, MN, United States of America.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Koops', 'Affiliation': 'Regions Hospital and HealthPartners, St. Paul, MN, United States of America; Critical Care Research Center, St. Paul, MN, United States of America.'}, {'ForeName': 'Lydia L', 'Initials': 'LL', 'LastName': 'Hamel', 'Affiliation': 'Regions Hospital and HealthPartners, St. Paul, MN, United States of America; Critical Care Research Center, St. Paul, MN, United States of America.'}, {'ForeName': 'Paula E', 'Initials': 'PE', 'LastName': 'Rupp', 'Affiliation': 'Regions Hospital and HealthPartners, St. Paul, MN, United States of America; Critical Care Research Center, St. Paul, MN, United States of America.'}, {'ForeName': 'Bjorn C', 'Initials': 'BC', 'LastName': 'Westgard', 'Affiliation': 'Regions Hospital and HealthPartners, St. Paul, MN, United States of America; Critical Care Research Center, St. Paul, MN, United States of America.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.07.039']
2283,33046345,Cost-effectiveness analysis of negative pressure wound therapy dressings after open inguinal vascular surgery - The randomised INVIPS-Trial.,"AIM


While the scientific evidence in favour of negative pressure wound therapy (NPWT) dressings on sutured incisions in the prevention of surgical site infections (SSIs) has increased, the cost-effectiveness after vascular surgery has not been evaluated. The aim of this study was to evaluate the cost-effectiveness of NPWT compared to standard dressings for the prevention of SSIs after open inguinal vascular surgery.
MATERIALS AND METHODS


Patient data were retrieved from the randomised INVIPS-trial's open arm, which included patients randomised to either NPWT or standard dressings. The patients were surveyed for SSIs for 90 days postoperatively. The patients' individual cost data were included and analysed from a healthcare perspective. The patients' quality of life was measured using the Vascuqol-6 questionnaire pre- and 30 days postoperatively. Cost-effectiveness of NPWT was determined by decreased or equal total costs and a significant reduction in SSI incidence.
RESULTS


The mean vascular procedure-related costs at 90 days were €16,621 for patients treated with NPWT (n = 59) and €16,285 for patients treated with standard dressings (n = 60), p = 0.85. The SSI incidence in patients treated with NPWT was 11.9% (n = 7/59) compared to 30.0% (n = 18/60) with standard dressings, p = 0.015. This corresponds to an increased mean cost of €1,853 per SSI avoided. The cost-effectiveness plane of incremental vascular procedure-related costs and difference in Vascuqol-6 score showed that 42% of estimates were in the quadrant where NPWT was dominant.
CONCLUSION


NPWT is considered cost-effective over standard dressings in patients undergoing open inguinal vascular surgery due to reduced SSI incidence at no higher costs.",2020,"CONCLUSION


NPWT is considered cost-effective over standard dressings in patients undergoing open inguinal vascular surgery due to reduced SSI incidence at no higher costs.","['patients undergoing open inguinal vascular surgery', 'Patient data', 'after open inguinal vascular surgery ']","['negative pressure wound therapy (NPWT) dressings', 'NPWT', 'NPWT or standard dressings', 'negative pressure wound therapy dressings']","['cost-effectiveness', 'SSI incidence', 'mean vascular procedure-related costs', 'mean cost', 'Cost-effectiveness of NPWT', 'Vascuqol-6 score', 'equal total costs', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0042381', 'cui_str': 'Vascular surgery procedure'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.045857,"CONCLUSION


NPWT is considered cost-effective over standard dressings in patients undergoing open inguinal vascular surgery due to reduced SSI incidence at no higher costs.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Svensson-Björk', 'Affiliation': 'Vascular Centre, Skåne University Hospital, Malmö, Sweden; Vascular Diseases Research Unit, Department of Clinical Sciences, Malmö, Lund University, Sweden. Electronic address: Robert.Svensson_Bjork@med.lu.se.'}, {'ForeName': 'Sanjib', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Health Economics Unit, Department of Clinical Sciences, Malmö, Lund University, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Acosta', 'Affiliation': 'Vascular Centre, Skåne University Hospital, Malmö, Sweden; Vascular Diseases Research Unit, Department of Clinical Sciences, Malmö, Lund University, Sweden.'}, {'ForeName': 'Ulf-G', 'Initials': 'UG', 'LastName': 'Gerdtham', 'Affiliation': 'Health Economics Unit, Department of Clinical Sciences, Malmö, Lund University, Sweden; Department of Economics, Lund University, Lund, Sweden.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Hasselmann', 'Affiliation': 'Vascular Centre, Skåne University Hospital, Malmö, Sweden; Vascular Diseases Research Unit, Department of Clinical Sciences, Malmö, Lund University, Sweden.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Asciutto', 'Affiliation': 'Vascular Diseases Research Unit, Department of Clinical Sciences, Malmö, Lund University, Sweden; Department of Vascular and Endovascular Surgery, University Hospital Muenster, Germany.'}, {'ForeName': 'Moncef', 'Initials': 'M', 'LastName': 'Zarrouk', 'Affiliation': 'Vascular Centre, Skåne University Hospital, Malmö, Sweden; Vascular Diseases Research Unit, Department of Clinical Sciences, Malmö, Lund University, Sweden.'}]",Journal of tissue viability,['10.1016/j.jtv.2020.09.005']
2284,33046459,US ex-doctor who ran fraudulent clinical trial sites is sentenced to 28 years in prison.,,2020,,['28 years in prison'],[],[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0392751', 'cui_str': 'In prison'}]",[],[],,0.0276733,,"[{'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Dyer', 'Affiliation': 'Montreal, Canada.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m3946']
2285,33044111,Distal Radial Artery Access for Superficial Femoral Artery Interventions.,"PURPOSE


To compare the acute success and complication rates of distal radial (DR) vs proximal radial (PR) artery access for superficial femoral artery (SFA) interventions.
MATERIALS AND METHODS


Between 2016 and 2019, 195 consecutive patients with symptomatic SFA stenosis were treated via DR (n=38) or PR (n=157) access using a sheathless guide. Secondary access was achieved through the pedal artery when necessary. The main outcomes were technical success, major adverse events (MAEs), and access site complications. Secondary outcomes were treatment success, fluoroscopy time, radiation dose, procedure time, and crossover rate to another puncture site.
RESULTS


Overall technical success was achieved in 188 patients (96.4%): 37 of 38 patients (97.3%) in the DR group and 151 of 157 patients (96.2%) in the PR group (p=0.9). Dual (transradial and transpedal) access was used in 14 patients (36.8%) in the DR group and 28 patients (18.9%) in the PR group (p<0.01). Chronic total occlusions were recanalized in 25 of 26 DR patients (96.1%) and in 79 of 81 PR patients (92.6%) (p=0.57). The crossover rate to femoral access was 0% in the DR group vs 3.2% in the PR group (p=0.59). Stents were implanted in the SFA in 15 DR patients (39.4%) and in 39 patients (24.8%) in the PR group (p=0.1). The contrast volume, fluoroscopy time, radiation dose, and procedure time were not statistically different between the DR and PR groups, nor were the rates of access site complications (2.6% and 7.0%, respectively). The cumulative incidences of MAE at 6 months in the DR and PR groups were 15.7% vs 14.6%, respectively (p=0.8).
CONCLUSION


SFA interventions can be safely and effectively performed using PR or DR access with acceptable morbidity and a high technical success rate. DR access is associated with few access site complications.",2020,"The contrast volume, fluoroscopy time, radiation dose, and procedure time were not statistically different between the DR and PR groups, nor were the rates of access site complications (2.6% and 7.0%, respectively).","['Between 2016 and 2019, 195 consecutive patients with symptomatic SFA stenosis were treated via DR (n=38) or PR (n=157) access using a sheathless guide']",['SFA interventions'],"['acute success and complication rates of distal radial (DR) vs proximal radial (PR) artery access', 'Chronic total occlusions', 'contrast volume, fluoroscopy time, radiation dose, and procedure time', 'treatment success, fluoroscopy time, radiation dose, procedure time, and crossover rate to another puncture site', 'rates of access site complications', 'technical success, major adverse events (MAEs), and access site complications', 'crossover rate to femoral access', 'Overall technical success', 'cumulative incidences of MAE']","[{'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0340574', 'cui_str': 'Superficial femoral artery stenosis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0447106', 'cui_str': 'Superficial femoral artery'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0286540', 'cui_str': 'MAV protocol'}]",195.0,0.0501676,"The contrast volume, fluoroscopy time, radiation dose, and procedure time were not statistically different between the DR and PR groups, nor were the rates of access site complications (2.6% and 7.0%, respectively).","[{'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Ruzsa', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Ádám', 'Initials': 'Á', 'LastName': 'Csavajda', 'Affiliation': 'Cardiology Division, Invasive Cardiology, Bács-Kiskun County Hospital, Kecskemét, Hungary.'}, {'ForeName': 'Balázs', 'Initials': 'B', 'LastName': 'Nemes', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Mónika', 'Initials': 'M', 'LastName': 'Deák', 'Affiliation': 'Cardiology Division, Invasive Cardiology, Bács-Kiskun County Hospital, Kecskemét, Hungary.'}, {'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Sótonyi', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Olivier F', 'Initials': 'OF', 'LastName': 'Bertrand', 'Affiliation': 'Quebec Heart-Lung Institute, University Laval, Quebec, QC, Canada.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602820963022']
2286,33044119,Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: 36-Month Results of the Viabahn 25 cm Trial.,"PURPOSE


To evaluate the 36-month technical and clinical outcome after implantation of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface in TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral and proximal popliteal arteries.
MATERIALS AND METHODS


This prospective, multicenter, single-arm trial ( ClinicalTrials.gov ; identifier NCT01263665) enrolled 71 patients (mean age 66.7±8.3 years; 50 men) with lifestyle-limiting claudication or rest pain (Rutherford category 2-4) and long (>20-cm) lesions of the superficial femoral and proximal popliteal arteries. Primary endpoint was primary patency at 36 months. Secondary endpoints included primary assisted patency; secondary patency; freedom from target lesion revascularization (TLR); freedom from a composite of death, target vessel revascularization (TVR), and amputation; clinical success; and freedom from device fracture.
RESULTS


Primary patency estimated by Kaplan-Meier analysis was 40.6% at 36 months. Primary assisted patency and secondary patency estimates were 53.0% and 96.9%, respectively. Within 36 months, 27 patients had to undergo a TLR. Twenty-five patients (35.2%) had a TVR. Freedom from the composite of death, TVR, and amputation endpoint was 44.5%. The estimate of the sustained clinical success with stable or improved Rutherford category was 58.5%. No stent fracture was detected during follow-up.
CONCLUSION


The primary patency rate without reintervention after treatment of long femoropopliteal lesions is low. However, secondary patency after implantation of a Viabahn endoprosthesis is high and seems to be superior to the use of other revascularization techniques, resulting in persistent clinical improvement.",2020,"No stent fracture was detected during follow-up.
","['TASC II C and D Femoropopliteal Lesions', '71 patients (mean age 66.7±8.3 years; 50 men) with lifestyle-limiting claudication or rest pain (Rutherford category 2-4) and long (>20-cm) lesions of the superficial femoral and proximal popliteal arteries', '27 patients had to undergo a TLR']","['Heparin-Bonded Stent-Graft', '25-cm Viabahn endoprosthesis with Propaten bioactive surface', 'Viabahn endoprosthesis']","['TVR', 'death, TVR, and amputation endpoint', 'stent fracture', 'primary assisted patency; secondary patency; freedom from target lesion revascularization (TLR); freedom from a composite of death, target vessel revascularization (TVR), and amputation; clinical success; and freedom from device fracture', 'patency and secondary patency estimates', 'patency rate without reintervention']","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C4704931', 'cui_str': 'Endoprostheses'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]","[{'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3160928', 'cui_str': 'Device fracture'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",71.0,0.133844,"No stent fracture was detected during follow-up.
","[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Böhme', 'Affiliation': 'Department Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Noory', 'Affiliation': 'Department Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Brechtel', 'Affiliation': 'Department Radiology, MVZ GmbH Berlin-Tiergarten, Berlin, Germany.'}, {'ForeName': 'Dierk', 'Initials': 'D', 'LastName': 'Scheinert', 'Affiliation': 'University Hospital Leipzig, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bosiers', 'Affiliation': 'Department Vascular Surgery, A.Z. Sint-Blasius, Dendermonde, Belgium.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Beschorner', 'Affiliation': 'CoreLab Black Forest Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zeller', 'Affiliation': 'Department Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602820965965']
2287,33044178,A Randomized Clinical Trial of Greek High Phenolic Early Harvest Extra Virgin Olive Oil in Mild Cognitive Impairment: The MICOIL Pilot Study.,"BACKGROUND


Extra virgin olive oil (EVOO) constitutes a natural compound with high protection over cognitive function.
OBJECTIVE


To investigate for the first time the effect of Greek High Phenolic Early Harvest Extra Virgin Olive Oil (HP-EH-EVOO) versus Moderate Phenolic (MP-EVOO) and Mediterranean Diet (MeDi) in people with mild cognitive impairment (MCI).
METHODS


We conducted a randomized prospective study so as to examine the HP-EH-EVOO and MP-EVOO versus MeDi in MCI. Genetic predisposition (APOEɛ4) to Alzheimer's disease (AD) was tested and an extensive neuropsychological battery was administered at baseline and after 12 months. Each participant was randomized and assigned one of three groups: 1) Group 1 received the HP-EH-EVOO (50 mL/day); 2) Group 2 received the MP-EVOO (50 mL/day), and 3) Group 3 received only the MeDi instructions.
RESULTS


Better follow-up performance was found in Group 1 compared to Group 2 and Group 3 in the almost all cognitive domains. Moreover, Group 2 showed also significant improvement compared to Group 3 in ADAS-cog (p = 0.001) and MMSE (p = 0.05), whereas Group 3 exhibited worse or similar to baseline performance in almost all domains. In particular, Group 1 and Group 2 had better outcomes with regards to ADAS-cog (p = 0.003), Digit Span (p = 0.006), and Letter fluency (p = 0.003). Moreover, there was a significant difference (p = 0.001) in the presence of APOEɛ4 between the Groups 1 and 2 versus Group 3.
CONCLUSION


Long-term intervention with HP-EH-EVOO or MP-EVOO was associated with significant improvement in cognitive function compared to MeDi, independent of the presence of APOEɛ4.",2020,"RESULTS


Better follow-up performance was found in Group 1 compared to Group 2 and Group 3 in the almost all cognitive domains.","['people with mild cognitive impairment (MCI', 'Mild Cognitive Impairment']","['HP-EH-EVOO and MP-EVOO versus MeDi', 'Greek High Phenolic Early Harvest Extra Virgin Olive Oil (HP-EH-EVOO) versus Moderate Phenolic (MP-EVOO) and Mediterranean Diet (MeDi', 'MeDi instructions', 'Greek High Phenolic Early Harvest Extra Virgin Olive Oil', 'HP-EH-EVOO', 'MP-EVOO', 'Extra virgin olive oil (EVOO', 'HP-EH-EVOO or MP-EVOO']","['Letter fluency', 'cognitive function', 'presence of APOEɛ4', 'MMSE', 'Digit Span']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0337806', 'cui_str': 'Greeks'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0359916', 'cui_str': 'Substance with phenol structure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}]",,0.141676,"RESULTS


Better follow-up performance was found in Group 1 compared to Group 2 and Group 3 in the almost all cognitive domains.","[{'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Tsolaki', 'Affiliation': 'Department of Neurology General University Hopsital ""AHEPA"", Medical School, Faculty of Health Sciences, Aristotle University of Thessaloniki, Makedonia, Greece.'}, {'ForeName': 'Eftychia', 'Initials': 'E', 'LastName': 'Lazarou', 'Affiliation': ""Greek Association of Alzheimer's Disease and Related Disorders, Thessaloniki, Makedonia, Greece.""}, {'ForeName': 'Mahi', 'Initials': 'M', 'LastName': 'Kozori', 'Affiliation': ""Greek Association of Alzheimer's Disease and Related Disorders, Thessaloniki, Makedonia, Greece.""}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Petridou', 'Affiliation': ""Greek Association of Alzheimer's Disease and Related Disorders, Thessaloniki, Makedonia, Greece.""}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Tabakis', 'Affiliation': 'Department of Neurology General University Hopsital ""AHEPA"", Medical School, Faculty of Health Sciences, Aristotle University of Thessaloniki, Makedonia, Greece.'}, {'ForeName': 'Ioulietta', 'Initials': 'I', 'LastName': 'Lazarou', 'Affiliation': 'Department of Neurology General University Hopsital ""AHEPA"", Medical School, Faculty of Health Sciences, Aristotle University of Thessaloniki, Makedonia, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Karakota', 'Affiliation': ""Greek Association of Alzheimer's Disease and Related Disorders, Thessaloniki, Makedonia, Greece.""}, {'ForeName': 'Iordanis', 'Initials': 'I', 'LastName': 'Saoulidis', 'Affiliation': 'Department of Neurology General University Hopsital ""AHEPA"", Medical School, Faculty of Health Sciences, Aristotle University of Thessaloniki, Makedonia, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Melliou', 'Affiliation': 'Department of Pharmacognosy and Natural Products Chemistry, Faculty of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis Zografou, Athens, Greece.'}, {'ForeName': 'Prokopios', 'Initials': 'P', 'LastName': 'Magiatis', 'Affiliation': 'Department of Pharmacognosy and Natural Products Chemistry, Faculty of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis Zografou, Athens, Greece.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200405']
2288,33044292,Colonic J-Pouch or Straight Colorectal Reconstruction After Low Anterior Resection For Rectal Cancer: Impact on Quality of Life and Bowel Function: A Multicenter Prospective Randomized Study.,"BACKGROUND


Patient-reported outcomes associated with different bowel reconstruction techniques following anterior resection for rectal cancer are still a matter of debate.
OBJECTIVE


This study aimed to assess quality of life and bowel function in patients who underwent colonic J-pouch or straight colorectal anastomosis reconstruction after low anterior resection.
DESIGN


Bowel function and quality of life were assessed within a multicenter randomized trial. Questionnaires were administered before the surgery (baseline) and at 6, 12, and 24 months after surgery.
SETTINGS


Patients were enrolled by 19 centers. The enrollment started in October 2009 and was stopped in February 2016. The study was registered at www.clinicaltrials.gov (Identifier: NCT01110798).
PATIENTS


Patients who underwent low anterior resection for primary mid-low rectal cancer and who were randomly assigned in a 1:1 ratio to receive either stapled colonic J-pouch or straight colorectal anastomosis were selected.
MAIN OUTCOME MEASURES


The primary outcomes measured were quality of life and bowel function.
RESULTS


Of the 379 patients who were evaluable, 312 (82.3%) completed the baseline, 259 (68.3%) the 6-month, 242 (63.9%) the 12-month, and 199 (52.5%) the 24-month assessment. Bowel functioning and quality of life did not significantly differ between arms for almost all domains. The total bowel function score, the urgency, and the stool fractionation scores significantly worsened after surgery and remained impaired over time in both arms (p < 0.0032), whereas constipation improved after surgery but recovered to baseline levels from 1 year onward (p < 0.0036). All patients showed a significant and continuous improvement in emotional functioning (p < 0.0013) and future perspective (p < 0.0001) from baseline to the end of the study.
LIMITATIONS


Limitations of the study include missing data, which increased over time; the possibility that some treatments have slightly changed since the study was conducted; and investigators not blind to treatment allocation.
CONCLUSION


The findings of this study do not support the routine use of colonic J-pouch reconstruction in patients with rectal cancer who undergo a low anterior resection. See Video Abstract at http://links.lww.com/DCR/B328. BOLSA J COLÓNICA O RECONSTRUCCIÓN COLORRECTAL RECTA DESPUÉS DE RESECCIÓN ANTERIOR BAJA PARA CÁNCER RECTAL: IMPACTO EN LA CALIDAD DE VIDA Y LA FUNCIÓN INTESTINAL: UN ESTUDIO ALEATORIZADO PROSPECTIVO MULTICÉNTRICO: Los resultados informados por el paciente asociados con diferentes técnicas de reconstrucción intestinal después de la resección anterior para el cáncer de recto aún son tema de debate.Evaluar la calidad de vida y la función intestinal en pacientes que se sometieron a una bolsa en J colónica o reconstrucción de anastomosis colorrectal recta después de una resección anterior baja.La función intestinal y la calidad de vida se evaluaron en un ensayo aleatorizado multicéntrico. Los cuestionarios se administraron antes de la cirugía (basal) y a los 6, 12 y 24 meses después de la cirugía.Los pacientes fueron incluidos en 19 centros. La inscripción comenzó en Octubre de 2009 y se detuvo en Febrero de 2016. El estudio se registró en www.clinicaltrials.gov (Identificador: NCT01110798).Pacientes que se sometieron a resección anterior baja por cáncer rectal primario medio-bajo y que fueron aleatorizados en una proporción de 1: 1 para recibir bolsa J colónica con grapas o anastomosis colorrectal recta.calidad de vida y función intestinal.De los 379 pacientes que fueron evaluables, 312 (82.3%) completaron la evaluación inicial, 259 (68.3%) a los 6 meses, 242 (63.9%) a los 12 meses y 199 (52.5%) a los 24 meses. . El funcionamiento intestinal y la calidad de vida no difirieron significativamente entre los dos grupos en casi todos los dominios. La puntuación total de la función intestinal, la urgencia y las puntuaciones de fraccionamiento de las heces empeoraron significativamente después de la cirugía y continuaron con el tiempo extra en ambos grupos (p <0.0032), mientras que el estreñimiento mejoró después de la cirugía pero se recuperó a los niveles basales a partir de 1 año en adelante (p <0.0036). Todos los pacientes mostraron una mejora significativa y continua en el funcionamiento emocional (p <0.0013) y la perspectiva futura (<0.0001) desde el inicio hasta el final del estudio.Datos faltantes, que aumentaron con el tiempo; la posibilidad de que algunos tratamientos hayan cambiado ligeramente desde que se realizó el estudio; investigadores no cegados a la asignación del tratamiento.Los hallazgos de este estudio no respaldan el uso rutinario de la reconstrucción de la bolsa J colónica en pacientes con cáncer rectal que se someten a una resección anterior baja. Consulte Video Resumen en http://links.lww.com/DCR/B328. (Traducción-Dr. Yesenia Rojas-Khalil).",2020,y la calidad de vida no difirieron significativamente entre los dos grupos en casi todos los dominios.,"['patients with rectal cancer who undergo a low anterior resection', 'De los 379 pacientes', 'Patients who underwent low anterior resection for primary mid-low rectal cancer', 'Todos los pacientes mostraron', 'resección anterior baja por cáncer rectal primario medio-bajo y que fueron aleatorizados en una proporción', 'Patients were enrolled by 19 centers', 'Evaluar la calidad de vida y la función intestinal en', 'de 1: 1 para recibir bolsa J colónica con grapas', 'patients who underwent', 'empeoraron significativamente después de la cirugía']","['stapled colonic J-pouch or straight colorectal anastomosis were selected', 'Colonic J-Pouch or Straight Colorectal Reconstruction', 'BOLSA J COLÓNICA O RECONSTRUCCIÓN COLORRECTAL RECTA DESPUÉS DE', 'colonic J-pouch reconstruction', 'Low Anterior Resection For Rectal Cancer', 'colonic J-pouch or straight colorectal anastomosis reconstruction after low anterior resection']","['quality of life and bowel function', 'pacientes que se sometieron', 'Los hallazgos', 'total bowel function score, the urgency, and the stool fractionation scores', 'Quality of Life and Bowel Function', 'de este estudio', 'Los cuestionarios se administraron antes de la cirugía (basal', 'Bowel functioning and quality of life', 'emotional functioning', 'constipation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0442000', 'cui_str': 'Lower anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0376250', 'cui_str': 'Portuguese language'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0030563', 'cui_str': 'Parity'}]","[{'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0086492', 'cui_str': 'J pouch'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0278307', 'cui_str': 'Coloproctostomy'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0442000', 'cui_str': 'Lower anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}, {'cui': 'C0740175', 'cui_str': 'Before values'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",,0.038714,y la calidad de vida no difirieron significativamente entre los dos grupos en casi todos los dominios.,"[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gavaruzzi', 'Affiliation': 'Department of Developmental Psychology and Socialization, University of Padua, Padua, Italy.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Pace', 'Affiliation': 'Department of Colorectal Surgical Oncology, Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale, Naples, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Giandomenico', 'Affiliation': 'First Surgical Clinic, Department of Surgical, Oncological and Gastroenterological Sciences, University of Padua, Padua, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Pucciarelli', 'Affiliation': 'First Surgical Clinic, Department of Surgical, Oncological and Gastroenterological Sciences, University of Padua, Padua, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bianco', 'Affiliation': 'Department of Abdominal Oncology, Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale, Naples, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Selvaggi', 'Affiliation': ""Colorectal Surgery Unit, Department of Medical, Surgical, Neurological, Metabolic and Ageing Sciences, University of Campania 'Luigi Vanvitelli', Naples, Italy.""}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Restivo', 'Affiliation': 'Colorectal Surgery, Azienda Ospedaliero-Universitaria di Cagliari, Department of Surgical Science, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Corrado Rosario', 'Initials': 'CR', 'LastName': 'Asteria', 'Affiliation': 'Colo-rectal Surgery Unit, Department of Surgery and Orthopaedics, ASST ""Carlo Poma"", Mantua, Italy.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Morpurgo', 'Affiliation': 'Department of Surgery, Regional Centre for Laparoscopic and Robotic Surgery, Camposampiero Hospital, Padua, Italy.'}, {'ForeName': 'Dajana', 'Initials': 'D', 'LastName': 'Cuicchi', 'Affiliation': ""General Surgery Unit, Department of Alimentary Tract, Sant'Orsola-Malpighi Hospital, Bologna, Italy.""}, {'ForeName': 'Elio', 'Initials': 'E', 'LastName': 'Jovine', 'Affiliation': 'General Surgery and Emergency, Maggiore Hospital, Azienda Sanitaria Locale di Bologna, Bologna, Italy.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Coletta', 'Affiliation': 'Division of Emergency and Trauma Surgery, Emergency Department, Policlinico Umberto I, College of Medicine and Dentistry, Sapienza University, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'La Torre', 'Affiliation': 'Abdominal Surgical Oncology, Department of Surgery, IRCCS, Centro di Riferimento Oncologico della Basilicata, Rionero in Vulture, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Amato', 'Affiliation': 'Department of Coloproctology, Sanremo Hospital, Sanremo, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Chiappa', 'Affiliation': 'Innovative Techniques in Surgery Unit, European Institute of Oncology, University of Milan, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Marchegiani', 'Affiliation': 'First Surgical Clinic, Department of Surgical, Oncological and Gastroenterological Sciences, University of Padua, Padua, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rega', 'Affiliation': 'Department of Colorectal Surgical Oncology, Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale, Naples, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'De Franciscis', 'Affiliation': 'Department of Abdominal Oncology, Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale, Naples, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pellino', 'Affiliation': ""Colorectal Surgery Unit, Department of Medical, Surgical, Neurological, Metabolic and Ageing Sciences, University of Campania 'Luigi Vanvitelli', Naples, Italy.""}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Zorcolo', 'Affiliation': 'Colorectal Surgery, Azienda Ospedaliero-Universitaria di Cagliari, Department of Surgical Science, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Lotto', 'Affiliation': 'Department of Developmental Psychology and Socialization, University of Padua, Padua, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Boccia', 'Affiliation': 'Colo-rectal Surgery Unit, Department of Surgery and Orthopaedics, ASST ""Carlo Poma"", Mantua, Italy.'}, {'ForeName': 'Gaya', 'Initials': 'G', 'LastName': 'Spolverato', 'Affiliation': 'First Surgical Clinic, Department of Surgical, Oncological and Gastroenterological Sciences, University of Padua, Padua, Italy.'}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'De Salvo', 'Affiliation': 'Clinical Trials and Biostatistics Unit, Istituto Oncologico Veneto IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Delrio', 'Affiliation': 'Department of Colorectal Surgical Oncology, Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale, Naples, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Del Bianco', 'Affiliation': 'Clinical Trials and Biostatistics Unit, Istituto Oncologico Veneto IOV - IRCCS, Padua, Italy.'}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000001745']
2289,33044352,The Effect of Venlafaxine on Electrocardiogram Intervals During Treatment for Depression in Older Adults.,"PURPOSE/BACKGROUND


Venlafaxine is a commonly used antidepressant with both serotonergic and noradrenergic activity. There are concerns that it may prolong the corrected QT interval (QTc), and older adults may be at higher risk for this adverse effect, especially at higher dosages of the medication.
METHODS/PROCEDURES


In this secondary analysis of a prospective clinical trial, we measured changes in QTc and other electrocardiogram (ECG) parameters in 169 adults 60 years or older with a major depressive disorder treated acutely with venlafaxine extended release up to 300 mg daily. We examined the relationship of venlafaxine dosage and ECG parameters, as well as the relationship between serum levels of venlafaxine and ECG parameters.
FINDINGS/RESULTS


Venlafaxine exposure was not associated with an increase in QTc. Heart rate increased with venlafaxine treatment, whereas the PR interval shortened, and QRS width did not change significantly. The QTc change from baseline was not associated with venlafaxine dosages or serum concentrations. Age, sex, cardiovascular comorbidities, and depression remission status did not predict changes in QTc with venlafaxine.
IMPLICATIONS/CONCLUSIONS


Venlafaxine treatment did not prolong QTc or other ECG parameters, even in high dosages in older depressed adults. These findings indicate that venlafaxine does not significantly affect cardiac conduction in most older patients.",2020,"Heart rate increased with venlafaxine treatment, whereas the PR interval shortened, and QRS width did not change significantly.","['older depressed adults', 'Older Adults', 'older patients', 'extended release up to 300 mg daily', '169 adults 60 years or older with a major depressive disorder treated acutely with']","['Venlafaxine', 'venlafaxine']","['corrected QT interval (QTc', 'QTc', 'Electrocardiogram Intervals', 'Heart rate', 'cardiac conduction', 'PR interval shortened, and QRS width', 'QTc and other electrocardiogram (ECG) parameters']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0078569', 'cui_str': 'venlafaxine'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction'}, {'cui': 'C0520878', 'cui_str': 'Shortened PR interval'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",169.0,0.0214423,"Heart rate increased with venlafaxine treatment, whereas the PR interval shortened, and QRS width did not change significantly.","[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Behlke', 'Affiliation': 'From the Department of Psychiatry.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'From the Department of Psychiatry.'}, {'ForeName': 'Vy', 'Initials': 'V', 'LastName': 'Pham', 'Affiliation': 'From the Department of Psychiatry.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Division of Biostatistics.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Smith', 'Affiliation': 'Cardiovascular Division, Department of Medicine, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Yasmina', 'Initials': 'Y', 'LastName': 'Saade', 'Affiliation': 'Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Stefan', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001287']
2290,33044356,"Trazodone as an Alternative Treatment for Neuroleptic-Associated Akathisia: A Placebo-Controlled, Double-Blind, Clinical Trial.","BACKGROUND


Akathisia is a distressing extrapyramidal complication that follows the use of antipsychotic medications. Early treatment of neuroleptic-associated akathisia (NAA) is of great importance because it may lead to poor therapeutic response and ultimately treatment noncompliance. Considering the lack of adequate response of some patients to conventional treatments and the assumption that serotonin might be involved in the pathophysiology of the disease in addition to dopaminergic mechanisms, we aimed to evaluate the effectiveness of trazodone as an antidepressant agent with strong antagonistic effects on serotonin receptors in the treatment of akathisia.
METHODS


In a double-blind clinical trial, 52 patients receiving antipsychotic medications who were diagnosed to have mild to severe NAA using Barnes Akathisia Rating Scale were treated with trazodone 50 mg daily for 5 days and compared with the placebo control group.
RESULTS


Patients receiving trazodone did not show a significant difference compared with the control group in terms of the severity of akathisia symptoms until the third day of the study. In contrast, at the end of the fifth day, there was a significant improvement in objective (P = 0.01) and subjective (P = 0.001) symptoms of akathisia and the global clinical assessment of akathisia scale (P = 0.001). Moreover, there was no clear difference between trazodone and placebo group in terms of adverse effects.
CONCLUSIONS


Considering the antagonistic effect of trazodone on postsynaptic 5-hydroxytryptamine2A receptors as a possible mechanism of efficacy of this agent in the treatment of NAA, this study suggests that trazodone might be an effective and relatively safe drug.",2020,"RESULTS


Patients receiving trazodone did not show a significant difference compared with the control group in terms of the severity of akathisia symptoms until the third day of the study.",['52 patients receiving antipsychotic medications who were diagnosed to have mild to severe NAA using Barnes Akathisia Rating Scale'],"['placebo control group', 'placebo', 'neuroleptic-associated akathisia (NAA', 'trazodone', 'Trazodone', 'Placebo']","['symptoms of akathisia and the global clinical assessment of akathisia scale', 'adverse effects', 'severity of akathisia symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0040805', 'cui_str': 'Trazodone'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",52.0,0.0935611,"RESULTS


Patients receiving trazodone did not show a significant difference compared with the control group in terms of the severity of akathisia symptoms until the third day of the study.","[{'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Shams-Alizadeh', 'Affiliation': 'From the Neurosciences Research Center.'}, {'ForeName': 'Azad', 'Initials': 'A', 'LastName': 'Maroufi', 'Affiliation': 'From the Neurosciences Research Center.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Asadi', 'Affiliation': 'Departments of Psychiatry.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Rahmani', 'Affiliation': 'Community Medicine.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Hassanzadeh', 'Affiliation': 'From the Neurosciences Research Center.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001286']
2291,33044364,Effects of 5-Week Foam Rolling Intervention on Range of Motion and Muscle Stiffness.,"Kiyono, R, Onuma, R, Yasaka, K, Sato, S, Yahata, K, and Nakamura, M. Effects of 5-week foam rolling intervention on range of motion and muscle stiffness. J Strength Cond Res XX(X): 000-000, 2020-In clinical and sports settings, foam rolling (FR) intervention is widely used to increase the range of motion (ROM). But, the chronic effects of FR on ROM and muscle stiffness are unclear. This study aimed to investigate the effects of 5-weeks FR intervention on dorsiflexion ROM (DFROM) and shear elastic modulus of the medial gastrocnemius (MG) muscle. Accordingly, 30 healthy young adults were enrolled and randomly assigned to either the FR or control group with the former receiving 90 seconds of FR thrice per week over 5-weeks. Thereafter, DFROM, passive torque at DFROM, and shear elastic modulus of the MG during passive ankle dorsiflexion were assessed using a dynamometer and ultrasonography before and after 5-weeks. Our results showed that the FR group exhibited a significant increase in DFROM (Δ = 11.7%, p < 0.05, effect size = 0.39), but no changes in passive torque at DFROM, and shear elastic modulus at 0° and 10° dorsiflexion. Moreover, significant correlations were observed between change in DFROM and change in passive torque at DFROM in the FR group (rs = 0.607; p = 0.016). These results suggested that FR was an effective method to increase DFROM given its ability to change passive torque at DFROM (stretch tolerance) without altering muscle stiffness.",2020,"Moreover, significant correlations were observed between change in DFROM and change in passive torque at DFROM in the FR group (rs = 0.607; p = 0.016).","['30 healthy young adults', ' 000-000, 2020-In clinical and sports settings']","['5-Week Foam Rolling Intervention', '5-weeks FR intervention', 'FR or control group with the former receiving 90 seconds of FR', 'J Strength Cond Res XX(X', 'foam rolling (FR) intervention']","['DFROM', 'passive torque at DFROM, and shear elastic modulus', 'dorsiflexion ROM (DFROM) and shear elastic modulus of the medial gastrocnemius (MG) muscle', 'DFROM, passive torque at DFROM, and shear elastic modulus', 'Range of Motion and Muscle Stiffness', 'range of motion (ROM', 'DFROM and change in passive torque at DFROM', 'Kiyono, R, Onuma, R, Yasaka, K, Sato, S, Yahata, K, and Nakamura, M. Effects', 'range of motion and muscle stiffness']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C2350289', 'cui_str': 'Young Modulus'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",30.0,0.017755,"Moreover, significant correlations were observed between change in DFROM and change in passive torque at DFROM in the FR group (rs = 0.607; p = 0.016).","[{'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Kiyono', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata, Japan.'}, {'ForeName': 'Remi', 'Initials': 'R', 'LastName': 'Onuma', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, Niigata, Japan.'}, {'ForeName': 'Koki', 'Initials': 'K', 'LastName': 'Yasaka', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, Niigata, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Yahata', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata, Japan.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003757']
2292,33044411,Outcome of Early Hemostatic Intervention in Children With Sepsis and Nonovert Disseminated Intravascular Coagulation Admitted to PICU: A Randomized Controlled Trial.,"Critically ill children with sepsis may develop catastrophic thrombotic and hemorrhagic syndrome of disseminated intravascular coagulopathy as a final common pathway.
OBJECTIVES


Evaluation of the outcome of early hemostatic management of disseminated intravascular coagulopathy in patients with severe sepsis/septic shock admitted to PICU, before the development of clinically overt disseminated intravascular coagulopathy.
DESIGN


Prospective interventional, open label randomized controlled clinical trial.
SETTING


PICU at Alexandria University Children's Hospital.
PATIENTS


The study included 80 patients with proven severe sepsis/septic shock in nonovert disseminated intravascular coagulopathy stage. They were randomly assigned into two groups (group 1 and group 2).
INTERVENTIONS


Specific intervention was applied for group 1 (plasma transfusion, low-dose unfractionated heparin, and tranexamic acid).
MEASUREMENTS


All patients had assessment of Pediatric Index of Mortality 2 score, Pediatric Logistic Organ Dysfunction score, inotropic score, routine laboratory, and hemostatic tests including fibrin degradation products and D-dimers. Disseminated intravascular coagulopathy risk assessment scores were calculated on daily basis.
RESULTS


Mortality rate was significantly higher in group 2. Progression to overt disseminated intravascular coagulopathy was significantly more common among group 2 patients than group 1 (45% and 10%, respectively) (p < 0.0001). Disseminated intravascular coagulopathyRisk Assessment Scores were significantly higher on the second and fifth days among group 2 patients. The initial specific hemostatic intervention was the only significant predictor of survival and prevention of progression to overt disseminated intravascular coagulopathy.
CONCLUSIONS


Our results suggest that early use of a combination of fresh frozen plasma transfusion, low-dose heparin, and tranexamic acid in children with severe sepsis/septic shock in the ""window of opportunity"" before the development of overt disseminated intravascular coagulopathy stage was associated with better outcome for survival and prevention of progression to overt disseminated intravascular coagulopathy, with no increase in bleeding risk. Larger multicenter studies are needed to further prove this practice.",2020,"The initial specific hemostatic intervention was the only significant predictor of survival and prevention of progression to overt disseminated intravascular coagulopathy.
","['Critically ill children with sepsis', 'Children With Sepsis and Nonovert Disseminated Intravascular Coagulation Admitted to PICU', 'patients with severe sepsis/septic shock admitted to PICU, before the development of clinically overt disseminated intravascular coagulopathy', ""PICU at Alexandria University Children's Hospital"", 'children with severe sepsis/septic shock', '80 patients with proven severe sepsis/septic shock in nonovert disseminated intravascular coagulopathy stage']","['Early Hemostatic Intervention', 'Specific intervention was applied for group 1 (plasma transfusion, low-dose unfractionated heparin, and tranexamic acid', 'tranexamic acid']","['Mortality rate', 'Pediatric Index of Mortality 2 score, Pediatric Logistic Organ Dysfunction score, inotropic score, routine laboratory, and hemostatic tests including fibrin degradation products and D-dimers', 'bleeding risk', 'Disseminated intravascular coagulopathy risk assessment scores', 'Progression to overt disseminated intravascular coagulopathy', 'Disseminated intravascular coagulopathyRisk Assessment Scores']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0012739', 'cui_str': 'Disseminated intravascular coagulation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0278347', 'cui_str': 'Transfusion of plasma'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242415', 'cui_str': 'Logistics'}, {'cui': 'C3494458', 'cui_str': 'Organ Dysfunction Scores'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0163275', 'cui_str': 'Fibrin degradation product'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",80.0,0.077438,"The initial specific hemostatic intervention was the only significant predictor of survival and prevention of progression to overt disseminated intravascular coagulopathy.
","[{'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'El-Nawawy', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Mohamed I', 'Initials': 'MI', 'LastName': 'Elshinawy', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Doaa M', 'Initials': 'DM', 'LastName': 'Khater', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Azza A', 'Initials': 'AA', 'LastName': 'Moustafa', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Nehad M', 'Initials': 'NM', 'LastName': 'Hassanein', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Yasser A', 'Initials': 'YA', 'LastName': 'Wali', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Hanan F', 'Initials': 'HF', 'LastName': 'Nazir', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002578']
2293,33044421,"The ""PalliActive Caregivers"" Intervention for Caregivers of Patients With Cancer in Palliative Care: A Feasibility Pilot Study.","This pilot study aimed to assess the feasibility and possible effects of the ""PalliActive Caregivers,"" nursing intervention, on the uncertainty in illness and quality of life of family caregivers of patients with cancer receiving palliative care. This pilot study used a randomized controlled design. The participants were 80 family caregivers. The experimental group received the novel ""PalliActive Caregivers"" intervention. Data were collected using a sociodemographic form, the Uncertainty in Illness Scale, the Quality of Life scale, and an Intervention satisfaction questionnaire. The caregivers who received the intervention ""PalliActive Caregivers"" reported a high degree of satisfaction (9.74 on a 10-point scale). The intervention showed a significant decrease in uncertainty regarding illness in the experimental group (P = .009), as well as a significant decrease in the psychological well-being of quality of life within the experimental and control groups, before and after the intervention (P = .013, P = .010). It is recommended that future studies using the ""PalliActive Caregivers"" intervention examine the effects on other variables such as the burden of patient's symptoms, caregiver burden and rewards, self-efficacy in symptom management, competence, unmet needs, and satisfaction with care.",2020,"The intervention showed a significant decrease in uncertainty regarding illness in the experimental group (P = .009), as well as a significant decrease in the psychological well-being of quality of life within the experimental and control groups, before and after the intervention (P = .013, P = .010).","['Caregivers of Patients With Cancer in Palliative Care', 'patients with cancer receiving palliative care', 'participants were 80 family caregivers']","['PalliActive Caregivers,"" nursing intervention', 'novel ""PalliActive Caregivers"" intervention', 'PalliActive Caregivers"" Intervention']","['Quality of Life scale, and an Intervention satisfaction questionnaire', 'psychological well-being of quality of life', 'uncertainty regarding illness']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0051533', 'cui_str': 'Am 80'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]",80.0,0.0393185,"The intervention showed a significant decrease in uncertainty regarding illness in the experimental group (P = .009), as well as a significant decrease in the psychological well-being of quality of life within the experimental and control groups, before and after the intervention (P = .013, P = .010).","[{'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Arias-Rojas', 'Affiliation': 'Mauricio Arias-Rojas, PhD, MSc, RN, is assistant professor, Faculty of Nursing, Universidad de Antioquia, Medellin, Colombia. Sonia Carreño-Moreno, PhD, is associate Professor, Faculty of Nursing, Universidad Nacional de Colombia, Bogotá, Colombia. Natalia Arias-Quiroz, RN, is research assistant, Faculty of Nursing, Universidad de Antioquia, Medellin, Colombia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Carreño-Moreno', 'Affiliation': ''}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Arias-Quiroz', 'Affiliation': ''}]",Journal of hospice and palliative nursing : JHPN : the official journal of the Hospice and Palliative Nurses Association,['10.1097/NJH.0000000000000696']
2294,33044432,The Potential Role of Efficacy and Safety Evaluation of N-Acetylcysteine Administration During Liver Procurement. The NAC-400 Single Center Randomised Controlled Trial.,"BACKGROUND KNOWLEDGE


OBJECTIVE.: METHODS.: RESULTS.: CONCLUSIONS.",2020,RESULTS.,[],['N-Acetylcysteine'],[],[],"[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]",[],,0.313789,RESULTS.,"[{'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Gómez-Gavara', 'Affiliation': ''}, {'ForeName': 'Ángel Moya', 'Initials': 'ÁM', 'LastName': 'Herraiz', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hervás', 'Affiliation': ''}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Pérez-Rojas', 'Affiliation': ''}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'LaHoz', 'Affiliation': ''}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'López-Andújar', 'Affiliation': ''}]",Transplantation,['10.1097/TP.0000000000003487']
2295,33044435,Increased Duration of Exercise Decreases Rate of Nonresponse to Exercise but May Not Decrease Risk for Cancer Mortality.,"INTRODUCTION


Previous studies have observed an inverse relationship between exercise and breast cancer risk. However, there is inter-individual variability in response to exercise training interventions. We investigated whether increasing the dose of aerobic exercise (150 min·week or 300 min·week), while keeping intensity of exercise constant (70%-80% HRmax), decreases the number of exercise non-responders, and further decreases associated-risk for cancer mortality in our study population of women genetically pre-disposed for breast cancer.
METHODS


Healthy premenopausal women at elevated risk of breast cancer were randomized into control (<75 min·week, n=47), low-dose exercise (150 min·week, n=39), and high-dose exercise groups (300 min·week, n=39) for approximately six months. We assessed: 1) clinical effectiveness (CE), defined as an improvement in predicted VO2max of ≥1 mL·kg·min, and, twice the typical error (2x TE) of VO2max, as thresholds to classify exercise ""non-responders""; 2) CE and 2x TE relative to exercise adherence levels, and 3) related changes in VO2max to predicted cancer mortality risk.
RESULTS


Following our six month intervention we observed 23.5% of women in the low-dose group and 5.6% of women in the high-dose group were clinical non-responders (p=0.04). Clinical non-responder status was independent of adherence level Associated reduction in risk for cancer mortality was observed among 87.2% of women in the low-dose group and 94.9% in the high dose group (p=0.43).
CONCLUSION


Increasing volume (not intensity) of exercise via time spent exercising significantly decreases the number of ""non-responders"". True non-responders were observed as some women did not improve their fitness capacity despite high exercise adherence levels. Lastly, it appears 150 min·week is sufficient to decrease predicted risk of cancer mortality.",2020,"Increasing volume (not intensity) of exercise via time spent exercising significantly decreases the number of ""non-responders"".",['Healthy premenopausal women at elevated risk of breast cancer'],"['low-dose exercise', 'aerobic exercise (150 min·week or 300 min·week), while keeping intensity of exercise constant (70%-80% HRmax', 'Exercise']","['predicted VO2max of ≥1 mL·kg·min, and, twice the typical error (2x TE) of VO2max, as thresholds to classify exercise ""non-responders""; 2) CE and 2x TE relative to exercise adherence levels, and 3) related changes in VO2max to predicted cancer mortality risk', 'clinical effectiveness (CE', 'risk of cancer mortality', 'risk for cancer mortality', 'Cancer Mortality']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]","[{'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}]",,0.0490609,"Increasing volume (not intensity) of exercise via time spent exercising significantly decreases the number of ""non-responders"".","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, PA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Potiaumpai', 'Affiliation': ''}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Schmitz', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Sturgeon', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002539']
2296,33044437,Carbohydrate Supplementation and the Influence of Breakfast on Fuel Use in Hypoxia.,"PURPOSE


This study investigated the effect of carbohydrate supplementation on substrate oxidation during exercise in hypoxia after pre-exercise breakfast consumption and omission.
METHODS


Eleven men walked in normobaric hypoxia (FiO2 ~11.7%) for 90-min at 50% of hypoxic V[Combining Dot Above]O2max. Participants were supplemented with a carbohydrate beverage (1.2g·min glucose) and a placebo beverage (both enriched with U-C6 D-glucose) after breakfast consumption and after omission. Indirect calorimetry and isotope ratio mass spectrometry were used to calculate carbohydrate (exogenous and endogenous (muscle and liver)) and fat oxidation.
RESULTS


In the first 60-min of exercise, there was no significant change in relative substrate oxidation in the carbohydrate compared with placebo trial after breakfast consumption or omission (both p = 0.99). In the last 30-min of exercise, increased relative carbohydrate oxidation occurred in the carbohydrate compared with placebo trial after breakfast omission (44.0 ± 8.8 vs. 28.0 ± 12.3, p < 0.01) but not consumption (51.7 ± 12.3 vs. 44.2 ± 10.4, p = 0.38). In the same period, a reduction in relative liver (but not muscle) glucose oxidation was observed in the carbohydrate compared with placebo trials after breakfast consumption (liver: 7.7 ± 1.6% vs. 14.8 ± 2.3%, p < 0.01; muscle: 25.4 ± 9.4% vs. 29.4 ± 11.1%, p = 0.99) and omission (liver: 3.8 ± 0.8% vs. 8.7 ± 2.8%, p < 0.01; muscle: 19.4 ± 7.5% vs. 19.2 ± 12.2%, p = 0.99). No significant difference in relative exogenous carbohydrate oxidation was observed between breakfast consumption and omission trials (p = 0.14).
CONCLUSION


In acute normobaric hypoxia, carbohydrate supplementation increased relative carbohydrate oxidation during exercise (> 60 min) after breakfast omission, but not consumption.",2020,"No significant difference in relative exogenous carbohydrate oxidation was observed between breakfast consumption and omission trials (p = 0.14).
",['Eleven men walked in normobaric hypoxia (FiO2 ~11.7%) for 90-min at 50% of hypoxic V[Combining'],"['Carbohydrate Supplementation', 'carbohydrate beverage (1.2g·min glucose) and a placebo beverage (both enriched with U-C6 D-glucose', 'placebo', 'carbohydrate supplementation']","['muscle) glucose oxidation', 'relative exogenous carbohydrate oxidation', 'substrate oxidation', 'relative substrate oxidation', 'relative carbohydrate oxidation', 'carbohydrate (exogenous and endogenous (muscle and liver)) and fat oxidation', 'relative liver']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0556103', 'cui_str': 'Carbohydrate supplementation'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",11.0,0.145843,"No significant difference in relative exogenous carbohydrate oxidation was observed between breakfast consumption and omission trials (p = 0.14).
","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Griffiths', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Deighton', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Boos', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Rowe', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Morrison', 'Affiliation': 'Stable Isotope Biochemistry Laboratory, SUERC, University of Glasgow. East Kilbride, Scotland, United Kingdom.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Preston', 'Affiliation': 'Stable Isotope Biochemistry Laboratory, SUERC, University of Glasgow. East Kilbride, Scotland, United Kingdom.'}, {'ForeName': 'Roderick', 'Initials': 'R', 'LastName': 'King', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': ""O'Hara"", 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, United Kingdom.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002536']
2297,33044684,Efficacy and Safety of ABP 798: Results from the JASMINE Trial in Patients with Follicular Lymphoma in Comparison with Rituximab Reference Product.,"INTRODUCTION


ABP 798 is being developed as a biosimilar to rituximab reference product (RP), a CD20-directed cytolytic antibody that is approved in the US and EU for the treatment of non-Hodgkin lymphoma (NHL).
METHODS


This randomized, double-blind, comparative clinical study (JASMINE) evaluated the efficacy and safety of ABP 798 compared with rituximab RP. Adult, anti-CD20 treatment naïve patients diagnosed with grade 1, 2, or 3a follicular B-cell NHL expressing CD20 were randomized 1:1 to receive a 375 mg/m 2  infusion of either ABP 798 or rituximab RP once weekly for 4 weeks and at weeks 12 and 20. Tumor assessments were performed at baseline and weeks 12 and 28. Primary endpoint was the risk difference (RD) of overall response rate (ORR) of complete response, unconfirmed complete response, or partial response by week 28 based on data from central, independent, and blinded assessments of disease.
RESULTS


Of the 256 randomized patients, 254 were treated with ABP 798 (n = 128; 100%) or rituximab RP (n = 126; 98.4%); 96 (78.0%) patients in the ABP 798 group and 87 (70.2%) in the rituximab RP group had a best ORR by week 28. The point estimate of RD in ORR between ABP 798 and rituximab RP from the adjusted generalized linear model for stratification factors was 7.7%. Clinical equivalence was based on sequential testing of the one-sided 95% lower confidence limits and one-sided 95% upper confidence limits of RD in ORR (- 1.4% and 16.8%, respectively) which was within the prespecified non-inferiority margin (- 15%) and non-superiority margin (35.5%), respectively. Results of sensitivity analyses were consistent with the primary efficacy analysis. ABP 798 was also comparable to rituximab RP across additional secondary endpoints, further supporting the conclusion of similarity, and including: RD of ORR at week 12; trough serum concentrations; percent of patients with complete depletion of CD19+ cell count at day 8; safety; and immunogenicity.
CONCLUSIONS


These results support a conclusion of similar clinical efficacy between ABP 798 and rituximab RP in patients with follicular lymphoma.
NCT NUMBER


NCT02747043; first posted April 21, 2016.
EUDRACT NUMBER


2013-005,542-11; submitted 14 October, 2014.",2020,"Primary endpoint was the risk difference (RD) of overall response rate (ORR) of complete response, unconfirmed complete response, or partial response by week 28 based on data from central, independent, and blinded assessments of disease.
","['naïve patients diagnosed with grade 1, 2, or 3a follicular B-cell NHL expressing CD20', '256 randomized patients', 'patients with follicular lymphoma', 'Patients with Follicular Lymphoma in Comparison with Rituximab Reference Product']","['ABP', 'ABP 798 or rituximab RP', 'rituximab RP', 'anti-CD20 treatment']","['efficacy and safety', 'Efficacy and Safety', 'risk difference (RD) of overall response rate (ORR) of complete response, unconfirmed complete response, or partial response by week 28 based on data from central, independent, and blinded assessments of disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1868944', 'cui_str': ""Follicular B-cell non-Hodgkin's lymphoma""}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0054946', 'cui_str': 'Lymphocyte antigen CD20'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0001239', 'cui_str': 'Actin-binding protein'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0054946', 'cui_str': 'Lymphocyte antigen CD20'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",256.0,0.112772,"Primary endpoint was the risk difference (RD) of overall response rate (ORR) of complete response, unconfirmed complete response, or partial response by week 28 based on data from central, independent, and blinded assessments of disease.
","[{'ForeName': 'Dietger', 'Initials': 'D', 'LastName': 'Niederwieser', 'Affiliation': 'Division of Hematology and Oncology, University of Leipzig, Liebigstr. 19, 04106, Leipzig, Germany. Dietger.Niederwieser@medizin.uni-leipzig.de.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Schulich School of Medicine, Western University, Windsor, ON, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cobb', 'Affiliation': 'St. Vincent Frontier Cancer Center, Billings, MT, USA.'}, {'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Mo', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Cecily', 'Initials': 'C', 'LastName': 'Forsyth', 'Affiliation': 'Gosford Hospital, Gosford, NSW, Australia.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tucci', 'Affiliation': 'Hematology Department, ASST-Spedali Civili-Brescia, Brescia, Italy.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Hanes', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Delwail', 'Affiliation': 'Oncology-Hematology and Cell Therapy, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hajek', 'Affiliation': 'Department of Hematooncology, Faculty of Medicine, University Hospital Ostrava, University of Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chien', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Targeted oncology,['10.1007/s11523-020-00748-4']
2298,33044756,"Ixekizumab Improves Functioning and Health in the Treatment of Active Non-Radiographic Axial Spondyloarthritis: 52-Week Results, COAST-X Trial.","OBJECTIVE


To evaluate the effect of ixekizumab on self-reported functioning and health in patients with active non-radiographic axial spondyloarthritis (nr-axSpA).
METHODS


COAST-X is a randomized, controlled trial conducted in patients with nr-axSpA of 52-weeks duration. Participants were randomized 1:1:1 to receive subcutaneous 80 mg ixekizumab every 4 weeks (Q4W) or every 2 weeks (Q2W), or placebo for 52 Weeks. Self-reported functioning and health endpoints included the Medical Outcomes Study 36-Item Short Form Health Survey 36-item (SF-36), Assessment of SpondyloArthritis international Society Health Index (ASAS HI), and European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) health-utility.
RESULTS


Compared with placebo, ixekizumab treatment improved SF-36 Physical Component Summary scores from baseline (4.7 versus 8.9 IXE Q4W, p<0.05, 9.3 IXE Q2W, p<0.01), with greatest improvements observed in Physical Functioning, Role-physical and Bodily Pain domains at Weeks 16 and 52. Higher proportion of patients receiving ixekizumab reported ASAS HI improvements ≥3 from baseline at Weeks 16 (Q2W, p<0.05) and 52 (p<0.05). Significantly more patients on ixekizumab reported improvements in ASAS HI ""good health status"" (ASAS HI ≤5) at Weeks 16 (Q4W, p<0.05) and 52 (p<0.05). Patients on ixekizumab reported improvements in EQ-5D-5L versus placebo at Week 16 (0.11 versus 0.17 Q4W, 0.19 Q2W, p<0.05), which remained consistent at Week 52. There were no clinical meaningful differences in responses based on the ixekizumab dosing regimen (Q2W or Q4W).
CONCLUSION


Ixekizumab was superior to placebo improving self-reported functioning and health in patients with nr-axSpA at Weeks 16 and 52.",2020,"Compared with placebo, ixekizumab treatment improved SF-36 Physical Component Summary scores from baseline (4.7 versus 8.9 IXE Q4W, p<0.05, 9.3 IXE Q2W, p<0.01), with greatest improvements observed in Physical Functioning, Role-physical and Bodily Pain domains at Weeks 16 and 52.","['patients with nr-axSpA of 52-weeks duration', 'patients with active non-radiographic axial spondyloarthritis (nr-axSpA']","['Ixekizumab', 'placebo, ixekizumab', 'placebo', 'ixekizumab', 'subcutaneous 80 mg ixekizumab']","['ASAS HI ""good health status', 'SF-36 Physical Component Summary scores', 'EQ-5D-5L', 'Medical Outcomes Study 36-Item Short Form Health Survey 36-item (SF-36), Assessment of SpondyloArthritis international Society Health Index (ASAS HI), and European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) health-utility', 'Physical Functioning, Role-physical and Bodily Pain domains']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3889038', 'cui_str': 'Non-radiographic axial spondyloarthritis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",,0.175143,"Compared with placebo, ixekizumab treatment improved SF-36 Physical Component Summary scores from baseline (4.7 versus 8.9 IXE Q4W, p<0.05, 9.3 IXE Q2W, p<0.01), with greatest improvements observed in Physical Functioning, Role-physical and Bodily Pain domains at Weeks 16 and 52.","[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Walsh', 'Affiliation': 'University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Marina N', 'Initials': 'MN', 'LastName': 'Magrey', 'Affiliation': 'MetroHealth Medical Center, School of Medicine, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Baraliakos', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Herne, Germany.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Inui', 'Affiliation': 'Graduate School of Medicine, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Meng-Yu', 'Initials': 'MY', 'LastName': 'Weng', 'Affiliation': 'National Cheng Kung University Medical College and Hospital, Tainan, Taiwan.'}, {'ForeName': 'Ennio', 'Initials': 'E', 'LastName': 'Lubrano', 'Affiliation': 'Department of Medicine and Health Sciences, University of Molise, Campobasso, Italy.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Boonen', 'Affiliation': 'Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Lianne S', 'Initials': 'LS', 'LastName': 'Gensler', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Herne, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Hunter', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA, Herne.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA, Herne.'}, {'ForeName': 'Baojin', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA, Herne.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'León', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA, Herne.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Marcelino Sandoval Calderon', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA, Herne.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Kiltz', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Herne, Germany.'}]",Arthritis care & research,['10.1002/acr.24482']
2299,33046576,Central radiology assessment of the randomized phase III open-label OVHIPEC-1 trial in ovarian cancer.,"INTRODUCTION


Hyperthermic intraperitoneal chemotherapy (HIPEC) improved investigator-assessed recurrence-free survival and overall survival in patients with stage III ovarian cancer in the phase III OVHIPEC-1 trial. We analyzed whether an open-label design affected the results of the trial by central blinded assessment of recurrence-free survival, and tested whether HIPEC specifically targets the peritoneal surface by analyzing the site of disease recurrence.
METHODS


OVHIPEC-1 was an open-label, multicenter, phase III trial that randomized 245 patients after three cycles of neoadjuvant chemotherapy to interval cytoreduction with or without HIPEC using cisplatin (100 mg/m 2 ). Patients received three additional cycles of chemotherapy after surgery. Computed tomography (CT) scans and serum cancer antigen 125 (CA125) measurements were performed during chemotherapy, and during follow-up. Two expert radiologists reviewed all available CT scans. They were blinded for treatment allocation and clinical outcome. Central revision included Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurements and peritoneal cancer index scorings at baseline, during treatment, and during follow-up. Time to centrally-revised recurrence was compared between study arms using Cox proportional hazard models. Subdistribution models compared time to peritoneal recurrence between arms, accounting for competing risks.
RESULTS


CT scans for central revision were available for 231 patients (94%) during neoadjuvant treatment and 212 patients (87%) during follow-up. Centrally-assessed median recurrence-free survival was 9.9 months in the surgery group and 13.2 months in the surgery+HIPEC group (HR for disease recurrence or death 0.72, 95% CI 0.55 to 0.94; p=0.015). The improved recurrence-free survival and overall survival associated with HIPEC were irrespective of response to neoadjuvant chemotherapy and baseline peritoneal cancer index. Cumulative incidence of peritoneal recurrence was lower after surgery+HIPEC, but there was no difference in extraperitoneal recurrences.
CONCLUSION


Centrally-assessed recurrence-free survival analysis confirms the benefit of adding HIPEC to interval cytoreductive surgery in patients with stage III ovarian cancer, with fewer peritoneal recurrences. These results rule out radiological bias caused by the open-label nature of the study.",2020,The improved recurrence-free survival and overall survival associated with HIPEC were irrespective of response to neoadjuvant chemotherapy and baseline peritoneal cancer index.,"['ovarian cancer', '245 patients after three cycles of', 'patients with stage III ovarian cancer', 'patients with stage III ovarian cancer in the phase III OVHIPEC-1 trial']","['Hyperthermic intraperitoneal chemotherapy (HIPEC', 'neoadjuvant chemotherapy to interval cytoreduction with or without HIPEC using cisplatin', 'HIPEC', 'surgery+HIPEC', 'chemotherapy']","['investigator-assessed recurrence-free survival and overall survival', 'median recurrence-free survival', 'Computed tomography (CT) scans and serum cancer antigen 125 (CA125) measurements', 'peritoneal cancer index scorings', 'Cumulative incidence of peritoneal recurrence', 'Time to centrally-revised recurrence', 'extraperitoneal recurrences', 'recurrence-free survival and overall survival']","[{'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278687', 'cui_str': 'Ovarian cancer stage III'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}]",245.0,0.254354,The improved recurrence-free survival and overall survival associated with HIPEC were irrespective of response to neoadjuvant chemotherapy and baseline peritoneal cancer index.,"[{'ForeName': 'Simone N', 'Initials': 'SN', 'LastName': 'Koole', 'Affiliation': 'Department of Gynaecology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Bruijs', 'Affiliation': 'Amsterdam University Medical Center, University of Amsterdam Faculty of Medicine, Amsterdam, The Netherlands.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fabris', 'Affiliation': 'Department of Radiology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Sikorska', 'Affiliation': 'Department of Biostatistics, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Maurits', 'Initials': 'M', 'LastName': 'Engbersen', 'Affiliation': 'Department of Radiology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Jules H', 'Initials': 'JH', 'LastName': 'Schagen van Leeuwen', 'Affiliation': 'Department of Obstetrics & Gynecology, Sint Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Henk W R', 'Initials': 'HWR', 'LastName': 'Schreuder', 'Affiliation': 'Department of Gynecological Oncology, Universitair Medisch Centrum Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Ralph H', 'Initials': 'RH', 'LastName': 'Hermans', 'Affiliation': 'Department of Gynaecology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'van der Velden', 'Affiliation': 'Gynecological Oncology, Amsterdam University Medical Centres, Amsterdam, The Netherlands.'}, {'ForeName': 'Henriette J G', 'Initials': 'HJG', 'LastName': 'Arts', 'Affiliation': 'Department of Gynecological Oncology, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'van Ham', 'Affiliation': 'Obstetrics and Gynecology, University Medical Center Nijmegen, Nijmegen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Dam', 'Affiliation': 'Department of Gynaecologic Oncology, University Hospital Antwerp, Edegem, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vuylsteke', 'Affiliation': 'Department of Medical Oncology, CHU UCL Namur, Namur, Belgium.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Lahaye', 'Affiliation': 'Department of Radiology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Gabe', 'Initials': 'G', 'LastName': 'Sonke', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Willemien van', 'Initials': 'WV', 'LastName': 'Driel', 'Affiliation': 'Department of Gynaecology, Netherlands Cancer Institute, Amsterdam, The Netherlands w.v.driel@nki.nl.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001825']
2300,33046584,Web-Based Tailored Messaging to Increase Vaccination: A Randomized Clinical Trial.,"BACKGROUND


To increase vaccine acceptance, we created a Web-based the ""Vaccines and Your Baby"" intervention (VAYB) that provided new parents with vaccine information messages tailored to vaccine beliefs and values. We evaluated the effectiveness of the VAYB by comparing timely uptake of infant vaccines to an untailored version of the intervention (UT) or usual care intervention (UC) only.
METHODS


Between April 2016 and June 2019, we conducted a randomized clinical trial. Pregnant women and new parents were randomly assigned to the VAYB, UT, or UC arms. In the VAYB and UT arms, participants were exposed to interventions at 4 time points from pregnancy until their child was 15 months of age. The primary outcome was up-to-date status for recommended vaccines from birth to 200 days of age. A modified intent-to-treat analysis was conducted. Data were analyzed with logistic regression to generate odds ratios (ORs) and 95% confidence intervals (CIs).
RESULTS


We enrolled 824 participants (276 VAYB, 274 UT, 274 UC), 143 (17.4%) of whom were lost to follow-up. The up-to-date rates in the VAYB, UT, and UC arms were 91.44%, 92.86%, and 92.31%, respectively. Infants in the VAYB arm were not more likely to be up to date than infants in the UC arm (OR = 0.89; 95% CI, 0.45-1.76) or in the UT arm (OR = 0.82; 95% CI, 0.42-1.63). The odds of being up to date did not differ between UT and UC arms (OR = 1.08; 95% CI, 0.54-2.18).
CONCLUSIONS


Delivering Web-based vaccine messages tailored to parents' vaccine attitudes and values did not positively impact the timely uptake of infant vaccines.",2020,"The odds of being up to date did not differ between UT and UC arms (OR = 1.08; 95% CI, 0.54-2.18).
","['Pregnant women and new parents', 'We enrolled 824 participants (276 VAYB, 274 UT, 274 UC), 143 (17.4%) of whom were lost to follow-up', 'Between April 2016 and June 2019']","['Web-Based Tailored Messaging to Increase Vaccination', 'Delivering Web-based vaccine messages', 'intervention (UT) or usual care intervention (UC) only']",['up-to-date status'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",824.0,0.196029,"The odds of being up to date did not differ between UT and UC arms (OR = 1.08; 95% CI, 0.54-2.18).
","[{'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Glanz', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado; jason.m.glanz@kp.org.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Wagner', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Komal J', 'Initials': 'KJ', 'LastName': 'Narwaney', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pyrzanowski', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science and.'}, {'ForeName': 'Bethany M', 'Initials': 'BM', 'LastName': 'Kwan', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science and.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Sevick', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science and.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Dempsey', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science and.'}]",Pediatrics,['10.1542/peds.2020-0669']
2301,33046607,Probiotics for constipation in Parkinson's disease: A randomized placebo-controlled study.,"OBJECTIVE


To determine whether probiotics are effective for constipation, a common and often difficult-to-treat problem, in Parkinson's disease (PD).
METHODS


In this double-blind, randomized placebo-controlled single-centre trial, 280 PD patients were screened and 72 eligible patients were block-randomized (1:1) to receive either multi-strain probiotics capsules (n=34), or identical-appearing placebo (n=38), for four weeks. The primary endpoint was the change in the average number of spontaneous bowel movements (SBM) per week during the last two weeks of intervention, compared with the two-week pre-intervention phase, recorded by daily stool diary. Secondary outcome measures included changes in stool consistency, constipation severity score, and quality of life related to constipation. Satisfaction with intervention received was assessed. Change in levels of fecal calprotectin, a marker of intestinal inflammation, was an exploratory outcome.
RESULTS


SBM increased by 1.0±1.2/week after treatment with probiotics, and decreased by 0.3±1.0/week in the placebo group (mean difference 1.3, 95%CI: 0.8-1.8, P<0.001). Significant improvements were also seen for secondary outcomes after correction for multiple comparisons, including stool consistency (P=0.009) and quality of life related to constipation (P=0.001). In the treatment group, 65.6% reported satisfaction with the intervention, vs. only 21.6% in the placebo group (P<0.001). One patient (2.9%) in the treatment group withdrew due to a non-serious adverse event. Fecal calprotectin did not change significantly during the study.
CONCLUSIONS


Multi-strain probiotics treatment was effective for constipation in PD. Further studies are needed to investigate the long-term efficacy and safety of probiotics in PD, as well as their mechanisms of action.
CLASSIFICATION OF EVIDENCE


This study provides Class I evidence that for people with PD, multi-strain probiotics significantly increased the average number of spontaneous bowel movements per week.
CLINICALTRIALSGOV IDENTIFIER


NCT03377322.",2020,"Significant improvements were also seen for secondary outcomes after correction for multiple comparisons, including stool consistency (P=0.009) and quality of life related to constipation (P=0.001).","['280 PD patients were screened and 72 eligible patients', ""Parkinson's disease""]","['placebo', 'multi-strain probiotics capsules (n=34), or identical-appearing placebo', 'Probiotics']","['Change in levels of fecal calprotectin, a marker of intestinal inflammation', 'Fecal calprotectin', 'average number of spontaneous bowel movements (SBM', 'stool consistency', 'changes in stool consistency, constipation severity score, and quality of life related to constipation', 'SBM', 'quality of life related to constipation']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3889047', 'cui_str': 'Intestinal inflammation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0278015', 'cui_str': 'Change in stool consistency'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",280.0,0.49755,"Significant improvements were also seen for secondary outcomes after correction for multiple comparisons, including stool consistency (P=0.009) and quality of life related to constipation (P=0.001).","[{'ForeName': 'Ai Huey', 'Initials': 'AH', 'LastName': 'Tan', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo & Tan Chin Nam Centre for Parkinson's & Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia aihuey.tan@gmail.com.""}, {'ForeName': 'Shen-Yang', 'Initials': 'SY', 'LastName': 'Lim', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo & Tan Chin Nam Centre for Parkinson's & Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Kah Kian', 'Initials': 'KK', 'LastName': 'Chong', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo & Tan Chin Nam Centre for Parkinson's & Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Mohammad Addin', 'Initials': 'MA', 'LastName': 'Azhan A Manap', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo & Tan Chin Nam Centre for Parkinson's & Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Jia Wei', 'Initials': 'JW', 'LastName': 'Hor', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo & Tan Chin Nam Centre for Parkinson's & Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Jia Lun', 'Initials': 'JL', 'LastName': 'Lim', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo & Tan Chin Nam Centre for Parkinson's & Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Soon Chai', 'Initials': 'SC', 'LastName': 'Low', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo & Tan Chin Nam Centre for Parkinson's & Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Chun Wie', 'Initials': 'CW', 'LastName': 'Chong', 'Affiliation': 'School of Pharmacy, Monash University Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Sanjiv', 'Initials': 'S', 'LastName': 'Mahadeva', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Lang', 'Affiliation': ""Edmond J. Safra Program in Parkinson's Disease and the Morton and Gloria Shulman Movement Disorders Clinic, Toronto Western Hospital, Toronto, Canada.""}]",Neurology,['10.1212/WNL.0000000000010998']
2302,33046611,Association of white matter lesions and outcome after endovascular stroke treatment.,"OBJECTIVE


To investigate the association between white matter lesions (WML) and functional outcome in patients with acute ischemic stroke (AIS) and the modification of the effect of endovascular treatment (EVT) by WML.
METHODS


We used data from the Multicenter Randomized Clinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands (MR CLEAN) trial and assessed severity of WML on baseline non-contrast CT imaging (NCCT; n = 473) according to the Van Swieten Scale. Post-stroke functional outcome was assessed with the modified Rankin Scale (mRS). We investigated the association of WML with functional outcome using ordinal logistic regression models adjusted for age, sex, and other relevant cardiovascular and prognostic risk factors. In addition, an interaction term between treatment allocation and WML severity was used to assess treatment effect modification by WML.
RESULTS


We found an independent negative association between more severe WML and functional outcome (acOR 0.77 [95% CI 0.66-0.90]). Patients with absent to moderate WML had similar benefit of EVT on functional outcome (acOR 1.93 [95% CI 1.31-2.84]) as patients with severe WML (acOR 1.95 [95% CI 0.90-4.20]). No treatment effect modification of WML was found ( p  for interaction = 0.85).
CONCLUSIONS


We found that more severe WML predict poor functional outcome after acute ischemic stroke, but do not modify effect of EVT.
CLASSIFICATION OF EVIDENCE


Prognostic accuracy. This study provides Class II evidence that for patients with AIS, the presence of WML on baseline NCCT is associated with worse functional outcomes.",2020,Patients with absent to moderate WML had similar benefit of EVT on functional outcome (acOR 1.93,"['patients with acute ischemic stroke (AIS', 'Acute ischemic stroke in the Netherlands (MR CLEAN', 'patients with AIS']","['WML', 'Endovascular treatment', 'EVT', 'endovascular treatment (EVT) by WML']","['functional outcome', 'modified Rankin Scale (mRS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}]","[{'cui': 'C2752009', 'cui_str': 'White matter lesion'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",,0.147235,Patients with absent to moderate WML had similar benefit of EVT on functional outcome (acOR 1.93,"[{'ForeName': 'Sven P R', 'Initials': 'SPR', 'LastName': 'Luijten', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine (S.P.R.L., D.B., K.C.J.C., L.W., A.v.d.L., A.C.G.M.v.E.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands2. Department of Neurology (K.C.J.C., D.W.J.D.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 3. Department of Epidemiology (D.B.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 4. Department of Radiology (C.B.L.M.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands5. Department of Neurology (Y.B.W.E.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands6. Department of Radiology (W.H.v.Z.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, The Netherlands 7. Department of Neurology (R.J.v.O.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, the Netherlands. s.luijten@erasmusmc.nl.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bos', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine (S.P.R.L., D.B., K.C.J.C., L.W., A.v.d.L., A.C.G.M.v.E.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands2. Department of Neurology (K.C.J.C., D.W.J.D.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 3. Department of Epidemiology (D.B.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 4. Department of Radiology (C.B.L.M.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands5. Department of Neurology (Y.B.W.E.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands6. Department of Radiology (W.H.v.Z.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, The Netherlands 7. Department of Neurology (R.J.v.O.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Kars C J', 'Initials': 'KCJ', 'LastName': 'Compagne', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine (S.P.R.L., D.B., K.C.J.C., L.W., A.v.d.L., A.C.G.M.v.E.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands2. Department of Neurology (K.C.J.C., D.W.J.D.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 3. Department of Epidemiology (D.B.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 4. Department of Radiology (C.B.L.M.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands5. Department of Neurology (Y.B.W.E.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands6. Department of Radiology (W.H.v.Z.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, The Netherlands 7. Department of Neurology (R.J.v.O.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Lennard', 'Initials': 'L', 'LastName': 'Wolff', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine (S.P.R.L., D.B., K.C.J.C., L.W., A.v.d.L., A.C.G.M.v.E.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands2. Department of Neurology (K.C.J.C., D.W.J.D.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 3. Department of Epidemiology (D.B.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 4. Department of Radiology (C.B.L.M.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands5. Department of Neurology (Y.B.W.E.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands6. Department of Radiology (W.H.v.Z.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, The Netherlands 7. Department of Neurology (R.J.v.O.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine (S.P.R.L., D.B., K.C.J.C., L.W., A.v.d.L., A.C.G.M.v.E.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands2. Department of Neurology (K.C.J.C., D.W.J.D.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 3. Department of Epidemiology (D.B.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 4. Department of Radiology (C.B.L.M.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands5. Department of Neurology (Y.B.W.E.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands6. Department of Radiology (W.H.v.Z.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, The Netherlands 7. Department of Neurology (R.J.v.O.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Yvo B W E M', 'Initials': 'YBWEM', 'LastName': 'Roos', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine (S.P.R.L., D.B., K.C.J.C., L.W., A.v.d.L., A.C.G.M.v.E.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands2. Department of Neurology (K.C.J.C., D.W.J.D.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 3. Department of Epidemiology (D.B.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 4. Department of Radiology (C.B.L.M.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands5. Department of Neurology (Y.B.W.E.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands6. Department of Radiology (W.H.v.Z.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, The Netherlands 7. Department of Neurology (R.J.v.O.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Wim H', 'Initials': 'WH', 'LastName': 'van Zwam', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine (S.P.R.L., D.B., K.C.J.C., L.W., A.v.d.L., A.C.G.M.v.E.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands2. Department of Neurology (K.C.J.C., D.W.J.D.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 3. Department of Epidemiology (D.B.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 4. Department of Radiology (C.B.L.M.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands5. Department of Neurology (Y.B.W.E.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands6. Department of Radiology (W.H.v.Z.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, The Netherlands 7. Department of Neurology (R.J.v.O.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'van Oostenbrugge', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine (S.P.R.L., D.B., K.C.J.C., L.W., A.v.d.L., A.C.G.M.v.E.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands2. Department of Neurology (K.C.J.C., D.W.J.D.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 3. Department of Epidemiology (D.B.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 4. Department of Radiology (C.B.L.M.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands5. Department of Neurology (Y.B.W.E.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands6. Department of Radiology (W.H.v.Z.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, The Netherlands 7. Department of Neurology (R.J.v.O.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Diederik W J', 'Initials': 'DWJ', 'LastName': 'Dippel', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine (S.P.R.L., D.B., K.C.J.C., L.W., A.v.d.L., A.C.G.M.v.E.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands2. Department of Neurology (K.C.J.C., D.W.J.D.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 3. Department of Epidemiology (D.B.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 4. Department of Radiology (C.B.L.M.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands5. Department of Neurology (Y.B.W.E.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands6. Department of Radiology (W.H.v.Z.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, The Netherlands 7. Department of Neurology (R.J.v.O.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Aad', 'Initials': 'A', 'LastName': 'van der Lugt', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine (S.P.R.L., D.B., K.C.J.C., L.W., A.v.d.L., A.C.G.M.v.E.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands2. Department of Neurology (K.C.J.C., D.W.J.D.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 3. Department of Epidemiology (D.B.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 4. Department of Radiology (C.B.L.M.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands5. Department of Neurology (Y.B.W.E.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands6. Department of Radiology (W.H.v.Z.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, The Netherlands 7. Department of Neurology (R.J.v.O.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Adriaan C G M', 'Initials': 'ACGM', 'LastName': 'van Es', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine (S.P.R.L., D.B., K.C.J.C., L.W., A.v.d.L., A.C.G.M.v.E.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands2. Department of Neurology (K.C.J.C., D.W.J.D.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 3. Department of Epidemiology (D.B.), Erasmus MC, University Medical Center, Rotterdam, The Netherlands 4. Department of Radiology (C.B.L.M.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands5. Department of Neurology (Y.B.W.E.M.), Amsterdam University Medical Center, Location AMC, University of Amsterdam, The Netherlands6. Department of Radiology (W.H.v.Z.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, The Netherlands 7. Department of Neurology (R.J.v.O.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000010994']
2303,33046619,"Mexiletine in myotonic dystrophy type-1: A randomized, double-blind, placebo-controlled trial.","OBJECTIVE


To assess mexiletine's long-term safety and effect on 6 minute walk distance in a well-defined cohort of myotonic dystrophy type-1 (DM1) patients.
METHODS


We performed a randomized, double-blind, placebo-controlled trial of mexiletine (150 mg 3 times daily) to evaluate its efficacy and safety in a homogenous cohort of adult ambulatory DM1 patients. The primary outcome was change in 6-minute walk distance at 6 months. Secondary outcomes included changes in hand grip myotonia, strength, swallowing, forced vital capacity, lean muscle mass, Myotonic Dystrophy Health Index scores, and 24-hour Holter and EKG results at 3 and 6 months.
RESULTS


Forty-two participants were randomized and 40 completed the 6-month follow-up (n = 20 in both groups). No significant effects of mexiletine were observed on 6-minute walk distance, but hand grip myotonia was improved with mexiletine treatment. There were no differences between the mexiletine and placebo groups with respect to the frequency or type of adverse events. Changes in PR, QRS, and QTc intervals were similar in mexiletine and placebo-treated participants.
CONCLUSIONS


There was no benefit of mexiletine on six-minute walk distance at 6 months. Although mexiletine had a sustained positive effect on objectively measured hand grip myotonia, this was not seen in measures reflecting participants' perceptions of their myotonia. No effects of mexiletine on cardiac conduction parameters were seen over the 6-month follow-up period.
CLASSIFICATION OF EVIDENCE


This study provides Class I evidence that for ambulatory patients with DM1 mexiletine does not significantly change six-minute walk distance at 6 months.",2020,There were no differences between the mexiletine and placebo groups with respect to the frequency or type of adverse events.,"['homogenous cohort of adult ambulatory DM1 patients', 'Forty-two participants were randomized and 40 completed the 6-month follow-up (n = 20 in both groups', 'myotonic dystrophy type-1', '6 minute walk distance in a well-defined cohort of myotonic dystrophy type-1 (DM1) patients', 'ambulatory patients with']","['mexiletine', 'placebo', 'DM1 mexiletine', 'Mexiletine']","['6-minute walk distance, but hand grip myotonia', 'efficacy and safety', 'cardiac conduction parameters', 'Changes in PR, QRS, and QTc intervals', 'frequency or type of adverse events', 'changes in hand grip myotonia, strength, swallowing, forced vital capacity, lean muscle mass, Myotonic Dystrophy Health Index scores, and 24-hour Holter and EKG results at 3 and 6 months', '6-minute walk distance', 'change six-minute walk distance']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027126', 'cui_str': 'Steinert myotonic dystrophy syndrome'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0442825', 'cui_str': 'Well defined'}]","[{'cui': 'C0025887', 'cui_str': 'Mexiletine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0027125', 'cui_str': 'Myotonia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0027126', 'cui_str': 'Steinert myotonic dystrophy syndrome'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",42.0,0.774017,There were no differences between the mexiletine and placebo groups with respect to the frequency or type of adverse events.,"[{'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Heatwole', 'Affiliation': 'University of Rochester, Department of Neurology Chad_heatwole@URMC.rochester.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Luebbe', 'Affiliation': 'University of Rochester, Department of Neurology.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Rosero', 'Affiliation': 'University of Rochester, Department of Neurology.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Eichinger', 'Affiliation': 'University of Rochester, Department of Neurology.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Martens', 'Affiliation': 'University of Rochester, Department of Neurology.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hilbert', 'Affiliation': 'University of Rochester, Department of Neurology.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Dekdebrun', 'Affiliation': 'University of Rochester, Department of Neurology.'}, {'ForeName': 'Nuran', 'Initials': 'N', 'LastName': 'Dilek', 'Affiliation': 'University of Rochester, Department of Neurology.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Zizzi', 'Affiliation': 'University of Rochester, Department of Neurology.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Johnson', 'Affiliation': 'Virginia Commonwealth University.'}, {'ForeName': 'Araya', 'Initials': 'A', 'LastName': 'Puwanant', 'Affiliation': 'Wake Forest Baptist Health.'}, {'ForeName': 'Rabi', 'Initials': 'R', 'LastName': 'Tawil', 'Affiliation': 'University of Rochester, Department of Neurology.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Schifitto', 'Affiliation': 'University of Rochester, Department of Neurology.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Beck', 'Affiliation': 'University of Rochester, Department of Neurology.'}, {'ForeName': 'J Franklin', 'Initials': 'JF', 'LastName': 'Richeson', 'Affiliation': 'University of Rochester, Department of Neurology.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Zareba', 'Affiliation': 'University of Rochester, Department of Neurology.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Thornton', 'Affiliation': 'University of Rochester, Department of Neurology.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'McDermott', 'Affiliation': 'University of Rochester, Department of Neurology.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Moxley', 'Affiliation': 'University of Rochester, Department of Neurology.'}]",Neurology,['10.1212/WNL.0000000000011002']
2304,33047259,Cardiac autonomic recovery following traditional and augmented remote ischemic preconditioning.,"PURPOSE


While the possible ergogenic benefits of remote ischemic preconditioning (RIPC) make it an attractive training modality, the mechanisms of action remain unclear. Alterations in neural tone have been demonstrated in conjunction with circulatory occlusion, yet investigation of the autonomic nervous system following RIPC treatment has received little attention. We sought to characterize alterations in autonomic balance to both RIPC and augmented RIPC (RIPC aug ) performed while cycling, using acute and sustained autonomic indices.
METHODS


Thirteen participants (8M:5F) recorded baseline waking heart rate variability (HRV) for 5 days prior to treatment. Participants then completed control exercise (CON), RIPC, and RIPC aug  interventions in a randomized cross-over design. Cardiovascular measurements were recorded immediately before and after each intervention at rest, and during an orthostatic challenge. Waking HRV was repeated the morning after each intervention.
RESULTS


RIPC resulted in acutely reduced resting heart rates (HR) (∆ - 4 ± 6 bpm, P = 0.02) and suppressed HR 30 s following the orthostatic challenge compared to CON (64 ± 10 vs 74 ± 9 bpm, P = 0.003). RIPC aug  yielded elevated HRs compared to CON and RIPC prior to (P = 0.003) and during the orthostatic challenge (P = 0.002). RIPC aug  reduced LnSDNN (Baseline 4.39 ± 0.27; CON 4.44 ± 0.39; RIPC 4.41 ± 0.34; RIPC aug  4.22 ± 0.29, P = 0.02) and LnHfa power (Baseline 7.82 ± 0.54; CON 7.73 ± 1.11; RIPC 7.89 ± 0.78; RIPC aug  7.23 ± 0.87, P = 0.04) the morning after treatment compared to all other conditions.
CONCLUSIONS


Our data suggest that RIPC may influence HR acutely, possibly through a reduction in cardiac sympathetic activity, and that RIPC aug  reduces HRV through cardiac vagal withdrawal or increased cardiac sympathetic modulation, with alterations persisting until the following morning. These findings imply a dose-response relationship with potential for optimization of performance.",2020,RIPC aug  yielded elevated HRs compared to CON and RIPC prior to (P = 0.003) and during the orthostatic challenge (P = 0.002).,['Thirteen participants (8M:5F) recorded'],"['CON', 'remote ischemic preconditioning (RIPC', 'traditional and augmented remote ischemic preconditioning', 'control exercise (CON), RIPC, and RIPC aug  interventions']","['baseline waking heart rate variability (HRV', 'Waking HRV', 'RIPC aug  reduced LnSDNN', 'LnHfa power', 'autonomic balance', 'orthostatic challenge', 'Cardiac autonomic recovery', 'Cardiovascular measurements', 'resting heart rates (HR']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}]",13.0,0.2834,RIPC aug  yielded elevated HRs compared to CON and RIPC prior to (P = 0.003) and during the orthostatic challenge (P = 0.002).,"[{'ForeName': 'William N', 'Initials': 'WN', 'LastName': 'Morley', 'Affiliation': 'The Human Performance and Health Research Laboratory, Department of Human Health and Nutritional Sciences, Animal Science and Nutrition, University of Guelph, 50 Stone Road E., Guelph, ON, N1G 2W1, Canada.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Coates', 'Affiliation': 'The Human Performance and Health Research Laboratory, Department of Human Health and Nutritional Sciences, Animal Science and Nutrition, University of Guelph, 50 Stone Road E., Guelph, ON, N1G 2W1, Canada.'}, {'ForeName': 'Jamie F', 'Initials': 'JF', 'LastName': 'Burr', 'Affiliation': 'The Human Performance and Health Research Laboratory, Department of Human Health and Nutritional Sciences, Animal Science and Nutrition, University of Guelph, 50 Stone Road E., Guelph, ON, N1G 2W1, Canada. burrj@uoguelph.ca.'}]",European journal of applied physiology,['10.1007/s00421-020-04526-y']
2305,33047298,Patient-Reported Ocular Disorders and Symptoms in Adults with Moderate-to-Severe Atopic Dermatitis: Screening and Baseline Survey Data from a Clinical Trial.,"INTRODUCTION


Patients with atopic dermatitis (AD) have a greater risk of conjunctivitis and other ocular surface disorders than the general population. We evaluated the burden of ocular surface disorders and related symptoms prior to treatment initiation in adults with moderate-to-severe AD.
METHODS


Patients were enrolled in a randomized, placebo-controlled, double-blinded, phase 3 trial of dupilumab administered with concomitant topical corticosteroids. At the beginning of the screening period, all enrolled patients completed a survey of ocular disorder diagnoses received in the past year; at baseline, patients completed a survey of frequency and severity of ocular symptoms (discomfort, itching, redness, and tearing) experienced in the past month.
RESULTS


A total of 712 of 740 patients enrolled in the trial provided responses to the survey. At screening, 286 of 740 patients (38.6%) reported having at least one ocular disorder in the past year. At baseline, 499 of 712 respondents (70.1%) reported having at least one symptom within the past month. Of these patients, 4.4%, 6.0%, 5.5%, and 4.4%, respectively, reported having discomfort, itching, redness, and tearing all of the time. Mild discomfort, itching, redness, and tearing were reported by 26.1%, 33.7%, 30.8%, and 31.6% of patients, respectively, while 7.3%, 7.7%, 6.2%, and 4.2%, reported severe discomfort, itching, redness, and tearing, respectively.
CONCLUSIONS


These data demonstrate a high burden of ocular surface disorders and related symptoms in a population of adults with moderate-to-severe AD. Dermatologists should be aware of increased incidence of these disorders in AD and query their patients for signs and symptoms of eye disease. CLINICALTRIALS.
GOV REGISTRATION NUMBER


NCT02260986.",2020,"Mild discomfort, itching, redness, and tearing were reported by 26.1%, 33.7%, 30.8%, and 31.6% of patients, respectively, while 7.3%, 7.7%, 6.2%, and 4.2%, reported severe discomfort, itching, redness, and tearing, respectively.
","['Patients', 'Adults with Moderate-to-Severe Atopic Dermatitis', 'A total of 712 of 740 patients enrolled in the trial provided responses to the survey', 'Patients with atopic dermatitis (AD', 'adults with moderate-to-severe AD']","['placebo', 'dupilumab administered with concomitant topical corticosteroids']","['severe discomfort, itching, redness, and tearing, respectively', 'frequency and severity of ocular symptoms (discomfort, itching, redness, and tearing', 'survey of ocular disorder diagnoses', 'Mild discomfort, itching, redness, and tearing', 'having discomfort, itching, redness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]",740.0,0.187763,"Mild discomfort, itching, redness, and tearing were reported by 26.1%, 33.7%, 30.8%, and 31.6% of patients, respectively, while 7.3%, 7.7%, 6.2%, and 4.2%, reported severe discomfort, itching, redness, and tearing, respectively.
","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Weyne', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591-6707, USA. jonathan.weyne@regeneron.com.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'de Bruin-Weller', 'Affiliation': 'National Expertise Center of Atopic Dermatitis, Department of Dermatology and Allergology, University Medical Center, Utrecht, Netherlands.'}, {'ForeName': 'Errol', 'Initials': 'E', 'LastName': 'Prens', 'Affiliation': 'Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Asbell', 'Affiliation': 'Hamilton Eye Institute, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Sierka', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, USA.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591-6707, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Shumel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591-6707, USA.'}]",Dermatology and therapy,['10.1007/s13555-020-00456-x']
2306,33047321,The Fatty Acid Composition of Human Follicular Fluid Is Altered by a 6-Week Dietary Intervention That Includes Marine Omega-3 Fatty Acids.,"The fatty acid composition of human follicular fluid is important for oocyte development and for pregnancy following in vitro fertilization (IVF). This study investigated whether a dietary intervention that included an increase in marine omega-3 fatty acids, olive oil and vitamin D alters the fatty acid composition of human follicular fluid. The association of lifestyle factors with follicular fluid fatty acid composition was also investigated. Fifty-five couples awaiting IVF were randomized to receive the 6-week treatment intervention of olive oil for cooking, an olive oil-based spread, and a daily supplement drink enriched with vitamin D and the marine omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) and 56 couples were randomized to receive placebo equivalents. Dietary questionnaires were completed, and samples of blood were taken before and after the intervention. Follicular fluid was collected at oocyte retrieval and the fatty acid profile assessed using gas chromatography. In the control group, individual fatty acids in red blood cells and follicular fluid were significantly correlated. Furthermore, a healthier diet was associated with a lower percentage of follicular fluid arachidonic acid. The follicular fluid of women in the treatment group contained significantly higher amounts of EPA and DHA compared to the control group, while the omega-6 fatty acids linoleic, γ-linolenic, dihomo-γ-linolenic, and arachidonic were lower. This is the first report of a dietary intervention altering the fatty acid composition of follicular fluid in humans. Further research is required to determine whether this intervention improves oocyte quality.",2020,"The follicular fluid of women in the treatment group contained significantly higher amounts of EPA and DHA compared to the control group, while the omega-6 fatty acids linoleic, γ-linolenic, dihomo-γ-linolenic, and arachidonic were lower.","['humans', 'Fifty-five couples awaiting IVF', 'human follicular fluid']","['placebo equivalents', 'marine omega-3 fatty acids, olive oil and vitamin D', 'dietary intervention', 'olive oil for cooking, an olive oil-based spread, and a daily supplement drink enriched with vitamin D and the marine omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA']","['omega-6 fatty acids linoleic, γ-linolenic, dihomo-γ-linolenic, and arachidonic', 'EPA and DHA', 'individual fatty acids in red blood cells and follicular fluid', 'oocyte quality']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0016431', 'cui_str': 'Liquor Folliculi'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}]","[{'cui': 'C0133860', 'cui_str': 'Fatty Acids, Omega-6'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0016431', 'cui_str': 'Liquor Folliculi'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",55.0,0.0740443,"The follicular fluid of women in the treatment group contained significantly higher amounts of EPA and DHA compared to the control group, while the omega-6 fatty acids linoleic, γ-linolenic, dihomo-γ-linolenic, and arachidonic were lower.","[{'ForeName': 'Alexandra J', 'Initials': 'AJ', 'LastName': 'Kermack', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Wellstead', 'Affiliation': 'Complete Fertility Centre, Department of Obstetrics & Gynaecology, Princess Anne Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Helena L', 'Initials': 'HL', 'LastName': 'Fisk', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheong', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, UK.'}, {'ForeName': 'Franchesca D', 'Initials': 'FD', 'LastName': 'Houghton', 'Affiliation': 'Centre for Human Development, Stem Cells & Regeneration, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Macklon', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, UK.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, UK.'}]",Lipids,['10.1002/lipd.12288']
2307,33047325,The Coping With and Caring for Infants with Special Needs intervention was associated with improved motor development in preterm infants.,"AIM


We compared the impact of standard infant physiotherapy and the family-centred programme, Coping With and Caring for Infants with Special Needs (COPCA), in infants born before 32 weeks without significant brain lesions.
METHODS


This randomised controlled trial was carried out in patients' homes and outpatient settings in Switzerland between January 2016 and October 2019. We used data from the national SwissNeoNet register and an assessment battery that included infant and family outcomes and video analyses of therapy sessions. The Infant Motor Profile was the primary outcome instrument.
RESULTS


The COPCA group comprised six boys and two girls with a median gestational age of 27 weeks (range 25-30) and the standard care group comprised seven boys and one girl with a median gestational age of 29.5 weeks (range 26-31). COPCA participants improved significantly more between baseline and 18 months in the IMP variation (9.0 percentage points, 95% confidence interval 0.3-17.5) and performance (12.0 percentage points, 95% confidence interval 4.1-20.6) domains than standard care participants. COPCA coaching was positively associated with IMP scores at 18 months, but some standard care actions were negatively associated.
CONCLUSION


COPCA was associated with better motor outcome in infants born before 32 weeks than standard infant physiotherapy.",2020,"COPCA participants improved significantly more between baseline and 18 months in the IMP variation (9.0 percentage points, 95% confidence interval 0.3-17.5) and performance (12.0 percentage points, 95% confidence interval 4.1-20.6) domains than standard care participants.","['preterm infants', 'Infants with Special Needs (COPCA), in infants born before 32 weeks without significant brain lesions', 'group comprised six boys and two girls with a median gestational age of 27 weeks (range 25-30) and the standard care group comprised seven boys and one girl with a median gestational age of 29.5 weeks (range 26-31', ""patients' homes and outpatient settings in Switzerland between January 2016 and October 2019""]","['COPCA coaching', 'COPCA', 'standard infant physiotherapy and the family-centred programme, Coping With and Caring']","['IMP scores', 'IMP variation']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]","[{'cui': 'C0021533', 'cui_str': 'Inosine monophosphate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]",,0.179955,"COPCA participants improved significantly more between baseline and 18 months in the IMP variation (9.0 percentage points, 95% confidence interval 0.3-17.5) and performance (12.0 percentage points, 95% confidence interval 4.1-20.6) domains than standard care participants.","[{'ForeName': 'Schirin', 'Initials': 'S', 'LastName': 'Akhbari Ziegler', 'Affiliation': 'Zurich University of Applied Sciences ZHAW, School of Health Professions, Institute of Physiotherapy, Winterthur, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'von Rhein', 'Affiliation': 'Department of Pediatrics, Kantonsspital Winterthur, Winterthur, Switzerland.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Meichtry', 'Affiliation': 'Zurich University of Applied Sciences ZHAW, School of Health Professions, Institute of Physiotherapy, Winterthur, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Wirz', 'Affiliation': 'Zurich University of Applied Sciences ZHAW, School of Health Professions, Institute of Physiotherapy, Winterthur, Switzerland.'}, {'ForeName': 'Tjitske', 'Initials': 'T', 'LastName': 'Hielkema', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Rehabilitation Medicine, Center for Rehabilitation, Groningen, The Netherlands.'}, {'ForeName': 'Mijna', 'Initials': 'M', 'LastName': 'Hadders-Algra', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pediatrics, Division of Developmental Neurology, Groningen, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15619']
2308,33047340,A controlled trial of dissemination and implementation of a cardiovascular risk reduction strategy in small primary care practices.,"OBJECTIVE


To assess the effect of dissemination and implementation of an intervention consisting of practice facilitation and a risk-stratified, population management dashboard on cardiovascular risk reduction for patients at high risk in small, primary care practices.
STUDY SETTING


A total of 219 small primary care practices (≤10 clinicians per site) across North Carolina with primary data collection from electronic health records (EHRs) from the fourth quarter of 2015 through the second quarter of 2018.
STUDY DESIGN


We performed a stepped-wedge, stratified, cluster randomized trial of a one-year intervention consisting of practice facilitation utilizing quality improvement techniques coupled with a cardiovascular dashboard that included lists of risk-stratified adults, aged 40-79 years and their unmet treatment opportunities. The primary outcome was change in 10-Year ASCVD Risk score among all patients with a baseline score ≥10 percent from baseline to 3 months postintervention.
DATA COLLECTION/ EXTRACTION METHODS


Data extracts were securely transferred from practices on a nightly basis from their EHR to the research team registry.
PRINCIPLE FINDINGS


ASCVD risk scores were assessed on 437 556 patients and 146 826 had a calculated 10-year risk ≥10 percent. The mean baseline risk was 23.4 percent (SD ± 12.6 percent). Postintervention, the absolute risk reduction was 6.3 percent (95% CI 6.3, 6.4). Models considering calendar time and stepped-wedge controls revealed most of the improvement (4.0 of 6.3 percent) was attributable to the intervention and not secular trends. In multivariate analysis, male gender, age >65 years, low-income (<$40 000), and Black race (P < .001 for all variables) were each associated with greater risk reductions.
CONCLUSION


A risk-stratified, population management dashboard combined with practice facilitation led to substantial reductions of 10-year ASCVD risk for patients at high risk. Similar approaches could lead to effective dissemination and implementation of other new evidence, especially in rural and other under-resourced practices. Registration: ClinicalTrials.Gov 15-0479.",2020,"Postintervention, the absolute risk reduction was 6.3 percent (95% CI 6.3, 6.4).","['with a cardiovascular dashboard that included lists of risk-stratified adults, aged 40-79\xa0years and their unmet treatment opportunities', 'Data extracts were securely transferred from practices on a nightly basis from their EHR to the research team registry', 'patients at high risk', 'ASCVD risk scores were assessed on 437\xa0556 patients and 146\xa0826 had a calculated 10-year risk ≥10 percent', 'small primary care practices', 'A total of 219 small primary care practices (≤10 clinicians per site) across North Carolina with primary data collection from electronic health records (EHRs) from the fourth quarter of 2015 through the second quarter of 2018', 'patients at high risk in small, primary care practices']",['practice facilitation utilizing quality improvement techniques coupled'],"['mean baseline risk', '10-Year ASCVD Risk score', 'cardiovascular risk reduction', '10-year ASCVD risk', 'absolute risk reduction']","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517811', 'cui_str': '556'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0205436', 'cui_str': 'Second'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",437556.0,0.317543,"Postintervention, the absolute risk reduction was 6.3 percent (95% CI 6.3, 6.4).","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Cykert', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Keyserling', 'Affiliation': 'Division of General Internal Medicine and Clinical Epidemiology, The University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pignone', 'Affiliation': 'Department of Internal Medicine, The Dell Medical School, University of Texas, Austin, Texas, USA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'DeWalt', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Weiner', 'Affiliation': 'Department of Global Public Health, School of Public Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Justin G', 'Initials': 'JG', 'LastName': 'Trogdon', 'Affiliation': 'Department of Health Policy and Management, The Gillings School of Global Public Health, The University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wroth', 'Affiliation': 'Community Care of North Carolina, Raleigh, North Carolina, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Halladay', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Mackey', 'Affiliation': 'The North Carolina Area Health Education Centers Program, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fine', 'Affiliation': 'Department of Biostatistics, The Gillings School of Global Public Health, The University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jung', 'Initials': 'J', 'LastName': 'In Kim', 'Affiliation': 'Department of Statistics, Eberly College of Science, The Pennsylvania State University, University Park, Pennsylvania, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cene', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",Health services research,['10.1111/1475-6773.13571']
2309,33047405,"Comparative efficacy between localized 308-nm Excimer Light and targeted 311-nm Narrowband Ultraviolet B Phototherapy in vitiligo: a randomized, single-blind comparison study.","BACKGROUND


There is limited data to compare efficacy between recent 308-nm excimer and conventional 311-nm NB-UVB light in the treatment of vitiligo.
OBJECTIVE


To compare efficacy between 308-nm excimer light and 311-nm NB-UVB in patients with symmetrical vitiligo lesions.
METHODS


Thirty-six symmetrically paired vitiligo lesions on the same anatomical area were enrolled. One side of the symmetrical lesions was treated with localized 308-nm excimer light and the opposite side was treated with targeted 311-nm NB-UVB assigned randomly by computer. All lesions were treated with the same protocol, for 48 sessions. Repigmentation was evaluated using Vitiligo Area Scoring index (VASI) and grading the repigmentation with three independent investigators.
RESULTS


Thirty-six symmetrically vitiligo lesions were randomly treated, one side with 308-nm excimer light and the opposite side with 311-nm NB-UVB. After 48 sessions, a significantly lower VASI score and a higher grade of repigmentation were observed in 308-nm excimer light -treated side (p<0.001). Nine lesions (25%) treated with 308-nm excimer light and only five lesions (13.89%) treated with 311-nm NB-UVB achieved excellent repigmentation. The 308-nm excimer light and 311-nm NB-UVB -treated sides rapidly obtained 25% repigmentation within a mean of 19.42 sessions and 26.25 sessions, repectively (p = 0.002). There was no significant difference in mean cumulative UV dosage (p = 0.065). Side effect as phototoxicity was similar in both sides (p = 0.08).
CONCLUSION


Localized 308-nm excimer light appears to be more effective and also more rapidly induces repigmentation than targeted 311-nm NB-UVB for treatment of vitiligo.",2020,There was no significant difference in mean cumulative UV dosage (p = 0.065).,"['Thirty-six symmetrically vitiligo lesions', 'vitiligo', 'patients with symmetrical vitiligo lesions', 'Thirty-six symmetrically paired vitiligo lesions on the same anatomical area were enrolled']","['308-nm excimer light and 311-nm NB-UVB', 'localized 308-nm excimer light and the opposite side', '308-nm excimer light', 'localized 308-nm Excimer Light and targeted 311-nm Narrowband Ultraviolet B Phototherapy', '308-nm excimer and conventional 311-nm NB-UVB light']","['phototoxicity', 'mean cumulative UV dosage', 'excellent repigmentation', 'VASI score', 'Vitiligo Area Scoring index (VASI']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C3472306', 'cui_str': 'Narrowband ultraviolet B phototherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0162830', 'cui_str': 'Phototoxic dermatitis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0353462,There was no significant difference in mean cumulative UV dosage (p = 0.065).,"[{'ForeName': 'Pimsiri', 'Initials': 'P', 'LastName': 'Poolsuwan', 'Affiliation': 'Institute Of Dermatology, Department Of Medical Services, Ministry Of Public Health, Bangkok, Thailand.'}, {'ForeName': 'Chutima', 'Initials': 'C', 'LastName': 'Churee', 'Affiliation': 'Institute Of Dermatology, Department Of Medical Services, Ministry Of Public Health, Bangkok, Thailand.'}, {'ForeName': 'Bensachee', 'Initials': 'B', 'LastName': 'Pattamadilok', 'Affiliation': 'Institute Of Dermatology, Department Of Medical Services, Ministry Of Public Health, Bangkok, Thailand.'}]","Photodermatology, photoimmunology & photomedicine",['10.1111/phpp.12619']
2310,33047411,"Functional Recovery in Human Partial Thickness Skin Wounds After Application of Multicomponent Hydrolipidic Film (MAS063DP): A Prospective, Open-Label, Comparative Clinical Trial.","Acute and minor skin wounds are common in daily life. However, in clinical practice, after initial management in the acute phase, the wounds are managed mainly through observation, and the patients are usually lost to follow-up. Considering a multicomponent hydrolipidic dressing (MAS063DP) long-known for its safe application in eczema and recently in laser-induced wounds, we aimed to evaluate its ability in functional recovery of impaired skin integrity during wound healing. Sixteen patients (N=16) were enrolled and completed (n=8 vs. n=8) this prospective, open-label, vehicle-controlled clinical trial with 12-week follow-up. Transepidermal water, skin viscoelasticity and bioimpedance analysis were measured initially, at the 1 st  , 4 th  , 8 th  and 12 th  weeks. Improvements in these parameters were greater in the MAS063DP group (from 31.4 ± 9.0 to 16.4 ± 4.3 g/m 2  h, p<.001; from 77 ± 16 % to 88 ± 9 %, p<.05; from 4,182 ± 3,823 to 2,644 ± 1,772 Ω) than in the white petrolatum group. No significant adverse events occurred, and all participants were more satisfied with the intervention. In this study, MAS063DP can restore skin integrity and reinstitute physiologic function as a feasible and safe intervention more markedly than management through observation during the healing process by providing protective hydrolipidic layer on the skin with simultaneous anti-inflammatory and antioxidant activities from its key ingredients such as glycyrrhetinic acid, vitis vinifera, telmesteine, and vitamins C and E. This article is protected by copyright. All rights reserved.",2020,"No significant adverse events occurred, and all participants were more satisfied with the intervention.",['Sixteen patients (N=16) were enrolled and completed (n=8 vs. n=8'],"['Multicomponent Hydrolipidic Film (MAS063DP', 'multicomponent hydrolipidic dressing (MAS063DP', 'MAS063DP']","['adverse events', 'Transepidermal water, skin viscoelasticity and bioimpedance analysis']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C2355254', 'cui_str': 'MAS063DP'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",,0.0241507,"No significant adverse events occurred, and all participants were more satisfied with the intervention.","[{'ForeName': 'Erh-Ti', 'Initials': 'ET', 'LastName': 'Lin', 'Affiliation': 'Department of Education, China Medical University Hospital, Taichung, Taiwan (R.O.C.).'}, {'ForeName': 'Bor-Shyh', 'Initials': 'BS', 'LastName': 'Lin', 'Affiliation': 'Institute of Imaging and Biomedical Photonics, National Chiao Tung University, Tainan, Taiwan (R.O.C.).'}, {'ForeName': 'Li-Cheng', 'Initials': 'LC', 'LastName': 'Tsai', 'Affiliation': 'Department of Education, China Medical University Hospital, Taichung, Taiwan (R.O.C.).'}, {'ForeName': 'Wei-Kung', 'Initials': 'WK', 'LastName': 'Chen', 'Affiliation': 'Department of Emergency, China Medical University Hospital, Taichung, Taiwan (R.O.C.).'}, {'ForeName': 'Yen-Jen', 'Initials': 'YJ', 'LastName': 'Wang', 'Affiliation': 'Department of Dermatology, Mackay Memorial Hospital, Taipei, Taiwan (R.O.C.).'}, {'ForeName': 'Hsiu-Mei', 'Initials': 'HM', 'LastName': 'Chiang', 'Affiliation': 'Department of Cosmeceutics and Graduate Institute of Cosmeceutics, China Medical University, Taichung, Taiwan (R.O.C.).'}, {'ForeName': 'Chang-Cheng', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Aesthetic Medical Center, China Medical University Hospital, Taichung, Taiwan (R.O.C.).'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12866']
2311,33047417,Exploring patient and pharmacist perspectives on complex interventions for cardiovascular prevention: A qualitative descriptive process evaluation.,"BACKGROUND


The Assessing outcomes of enhanced Chronic disease Care through patient Education and a value-baSed formulary Study (ACCESS) is a randomized controlled trial evaluating two interventions targeting barriers to care among those at high risk of cardiovascular disease: copayment elimination for cardioprotective medications, and a tailored self-management support programme. We designed a process evaluation to better understand participant perspectives on the interventions.
DESIGN


We used a qualitative descriptive study design, collecting patient and pharmacist feedback via individual semi-structured telephone interviews and in-person focus groups. Data were analysed inductively using thematic analysis.
RESULTS


Fifty-three patients (39 interviews and 14 in two focus groups) and 20 pharmacists participated. Copayment elimination provided quality of life benefits: minimizing the need to 'cut-back', allowing 'peace of mind' and providing emotional support. Health-related benefits included: improving adherence to covered medications, and helping to afford non-covered goods. The only criticism was that not all medications and testing supplies were covered. Patients reported that the educational materials provided helpful information, acted as a reminder, improved confidence, improved adherence to medication, and helped initiate conversations with providers about indicated medication. Some participants felt that the educational materials were repetitive, overly medication-focused and not tailored enough. Pharmacists felt that their patients benefitted from both interventions, which improved patient adherence and communication with their patients.
CONCLUSION


The success of interventions intended to change behaviour is largely dependent upon participant's feelings that the intervention is helpful. This process evaluation provided insights into participants' perceptions on these interventions. Reception of both was largely positive with a few criticisms noted.",2020,"Patients reported that the educational materials provided helpful information, acted as a reminder, improved confidence, improved adherence to medication, and helped initiate conversations with providers about indicated medication.",['Fifty-three patients (39 interviews and 14 in two focus groups) and 20 pharmacists participated'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}]",[],[],53.0,0.0754554,"Patients reported that the educational materials provided helpful information, acted as a reminder, improved confidence, improved adherence to medication, and helped initiate conversations with providers about indicated medication.","[{'ForeName': 'David J T', 'Initials': 'DJT', 'LastName': 'Campbell', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Saunders-Smith', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Braden J', 'Initials': 'BJ', 'LastName': 'Manns', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Tonelli', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Ivers', 'Affiliation': 'Department of Family & Community Medicine, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Brenda R', 'Initials': 'BR', 'LastName': 'Hemmelgarn', 'Affiliation': 'Department of Medicine, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Ross T', 'Initials': 'RT', 'LastName': 'Tsuyuki', 'Affiliation': 'Department of Medicine, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Pannu', 'Affiliation': 'Emergence Creative, New York, NY, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'King-Shier', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}]",Health expectations : an international journal of public participation in health care and health policy,['10.1111/hex.13133']
2312,33047449,"Effect of one session of aerobic exercise associated with abdominal laser therapy in lipolytic activity, profile lipid and inflammatory markers.","OBJECTIVE


To evaluate the effect of one session of aerobic exercise associated with abdominal laser therapy in lipolytic activity, profile lipid and inflammatory markers (C-reactive protein - CRP).
METHODOLOGY


Experimental, randomized controlled study in 36 participants of female sex, divided into three groups: Placebo group (PG) (n=12), experimental group 1 (EG1) (n=11) and experimental group 2 (EG2) (n=13). The EG1 and EG2 performed the laser therapy protocol followed by 50 minutes of aerobic exercise on cycle ergometer, of 45% to 55% of reserve heart rate, however in EG2 the laser therapy was applied without power. The PG only performed the laser therapy protocol without power. The anthropometric measures were evaluated and all the participants was subject to blood samples at the beginning and at the end of the intervention for measure glycerol, lipid profile (total cholesterol, triglycerides, HDL and LDL) and CRP. One-Way Anova was used to compare the groups in the quantitative variables and Fisher's test to compare the groups in the qualitative variables. To compare the variables between moments (M0 and M1), we used the t-test for paired samples.
RESULTS


In the group that performed physical exercise and lipolytic laser and in the group that performs only physical exercise, there was a significant increase in glycerol mobilization between M0 and M1 (p <0.001). The same did not occur in the placebo group. Regarding the CRP levels and lipidic profile, no significant differences were observed between moments in the experimental groups.
CONCLUSION


It is concluded that one session of aerobic exercise associated with low level laser therapy and one session of aerobic exercise appears to be able to increase the lipolytic activity. However, appears that low level laser therapy does not provide increased value to the aerobic physical exercise by itself in lipolysis process.",2020,"Regarding the CRP levels and lipidic profile, no significant differences were observed between moments in the experimental groups.
",['36 participants of female sex'],"['physical exercise and lipolytic laser', 'placebo', 'aerobic exercise', 'Placebo', 'abdominal laser therapy']","['lipolytic activity, profile lipid and inflammatory markers', 'CRP levels and lipidic profile', 'lipolytic activity', 'glycerol mobilization', 'glycerol, lipid profile (total cholesterol, triglycerides, HDL and LDL) and CRP']","[{'cui': 'C0086287', 'cui_str': 'Female'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",36.0,0.0299662,"Regarding the CRP levels and lipidic profile, no significant differences were observed between moments in the experimental groups.
","[{'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Barbosa', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto Portugal.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Coimbra', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto Portugal.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Noites', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto Portugal.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Vilarinho', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto Portugal.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Carvalho', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto Portugal.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Amorim', 'Affiliation': 'Department of Clinical Analysis, School of Health, Polytechnic Institute of Porto Portugal.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Moreira', 'Affiliation': 'Department of Clinical Analysis, School of Health, Polytechnic Institute of Porto Portugal.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Melo', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto Portugal.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13781']
2313,33047455,Comparison of viral control between two tenofovir dose reduction regimens (300 mg every 48 hours versus 300 mg every 72 hours) in chronic hepatitis B patients with moderate renal impairment from tenofovir-induced renal dysfunction.,"Long-term use of tenofovir disoproxil fumarate (TDF) can induce renal dysfunction that requires TDF dose reduction. Previous studies showed that systemic drug use exerts a 3-fold higher risk of moderate renal impairment. This study aimed to compare viral control between two tenofovir dose reduction regimens in chronic hepatitis B (CHB) patients with moderate renal impairment from TDF-induced renal dysfunction.This non-inferiority, randomized controlled study was conducted at the Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. Virologically-suppressed CHB patients treated with TDF who had moderate renal impairment were randomly allocated to receive TDF 300 mg either every 48 or 72 hours. Forty-six patients (67.4% male) with a mean age of 62.8±7.8 years were enrolled. Among all patients, 34.8% were HBeAg positive, and 23.9% had cirrhosis. All included patients completed 12 months of follow-up. No patients had virological breakthrough. After dose reduction, estimated glomerular filtration rate (eGFR) was improved in both groups, but a higher proportion of patients had an eGFR >60 mL/min/1.73m 2  in the TDF every 72 hours group. Other renal parameters, including serum phosphate, tubular maximal reabsorption for phosphate per GFR, urine protein to creatinine ratio, urine sugar, and urine neutrophil gelatinase-associated lipocalin, were not significantly different between groups. Among TDF-treated CHB patients with TDF-induced moderate renal impairment, more aggressive dose reduction of TDF from every 48 hours to every 72 hours did not affect virological breakthrough. A higher proportion of patients in the TDF every 72 hours group had improvement in renal function.",2020,"After dose reduction, estimated glomerular filtration rate (eGFR) was improved in both groups, but a higher proportion of patients had an eGFR >","['Virologically-suppressed CHB patients treated with TDF who had moderate renal impairment', 'Forty-six patients (67.4% male) with a mean age of 62.8±7.8 years were enrolled', 'chronic hepatitis B patients with moderate renal impairment from tenofovir-induced renal dysfunction', 'Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand', 'chronic hepatitis B (CHB) patients with moderate renal impairment from TDF-induced renal dysfunction']","['tenofovir disoproxil fumarate (TDF', 'TDF', 'tenofovir']","['renal function', 'virological breakthrough', 'moderate renal impairment', 'serum phosphate, tubular maximal reabsorption for phosphate per GFR, urine protein to creatinine ratio, urine sugar, and urine neutrophil gelatinase-associated lipocalin', 'glomerular filtration rate (eGFR']","[{'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0262923', 'cui_str': 'Urine protein test'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017979', 'cui_str': 'Glycosuria'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",,0.02354,"After dose reduction, estimated glomerular filtration rate (eGFR) was improved in both groups, but a higher proportion of patients had an eGFR >","[{'ForeName': 'Watcharasak', 'Initials': 'W', 'LastName': 'Chotiyaputta', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Karn', 'Initials': 'K', 'LastName': 'Poosanasuwansri', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kraiwiporn', 'Initials': 'K', 'LastName': 'Kiattisunthorn', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Siwaporn', 'Initials': 'S', 'LastName': 'Chainuvati', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tawesak', 'Initials': 'T', 'LastName': 'Tanwandee', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of viral hepatitis,['10.1111/jvh.13420']
2314,33047468,"Response to Eriksson et al. A randomized, controlled trial comparing the immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccination to a repeated dose 13-valent pneumococcal conjugate vaccination in kidney transplant recipients.",We read with interest the article by M. Eriksson et al. 1  presenting results from a study designed to evaluate the safety and immunogenicity of pneumococcal vaccination given pre- and post-transplant to renal transplant patients. Optimizing protection from pneumococcal disease among high-risk patients is paramount and many countries have recommendations for solid organ transplant recipients to receive pneumococcal vaccines.,2020,Optimizing protection from pneumococcal disease among high-risk patients is paramount and many countries have recommendations for solid organ transplant recipients to receive pneumococcal vaccines.,"['renal transplant patients', 'kidney transplant recipients']",['23-valent pneumococcal polysaccharide vaccination'],"['immunogenicity and safety', 'safety and immunogenicity']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",1.0,0.0733964,Optimizing protection from pneumococcal disease among high-risk patients is paramount and many countries have recommendations for solid organ transplant recipients to receive pneumococcal vaccines.,"[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Souza Dawson', 'Affiliation': 'Global Medical and Scientific Affairs (Vaccines), Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Feemster', 'Affiliation': 'Global Medical and Scientific Affairs (Vaccines), Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'E David G', 'Initials': 'EDG', 'LastName': 'McIntosh', 'Affiliation': 'Executive Director Scientific Affairs (Vaccines), MSD, United Kingdom.'}, {'ForeName': 'Ulrike K', 'Initials': 'UK', 'LastName': 'Buchwald', 'Affiliation': 'Global Clinical Development, Merck & Co., Inc, Kenilworth, NJ, USA.'}]",Transplant infectious disease : an official journal of the Transplantation Society,['10.1111/tid.13493']
2315,33047488,Prophylactic Closed Suction Drainage Is Irrelevant to Accelerated Rehabilitation after Open Reduction and Internal Fixation for Closed Distal Femur Fractures.,"OBJECTIVE


To investigate whether closed suction drainage (CSD) is related to accelerated rehabilitation of patients after open reduction and internal fixation (ORIF) for closed distal femur fractures.
METHODS


This study was a prospective, randomized controlled clinical trial. Between October 2018 and June 2020, 160 closed distal femur fracture patients who were prepared for ORIF were prospectively randomized into two groups: a CSD group with the mean age of 57.91 ± 14.38 years (32 [40%] men and 48 [60%] women) and a non-CSD group with the mean age of 59.73 ± 17.55 years (27 [34%] men and 54 [66%] women). Wound visual analogue scale (VAS) pain scores, peri-wound skin temperature, hematocrit (Hct), hemoglobin (Hb) concentrations, hidden blood loss (HBL), dressing change, period of wound oozing, postoperative blood transfusion, and length of postoperative hospital stay were recorded. Postoperative wound complications, namely wound infections, wound haematoma, wound dehiscence, erythema of wound, and lower limb deep vein thrombosis (DVT) were collected. All the patients were administrated by a single surgical team and followed up for 1 month after the ORIF.
RESULTS


The patients without CSD were identified with lower peri-wound skin temperature and wound VAS pain scores during the first three postoperative days (36.69 ± 0.33 vs 36.86 ± 0.38 °C, P = 0.002; 1.88 ± 0.82 vs 3.15 ± 1.15, P = 0.000). However, both the peri-wound skin temperature and wound VAS pain scores did not differ significantly between the two groups on the fifth postoperative day. In addition, patients with CSD had a longer length of postoperative hospitalization time (11.45 ± 5.95 vs 9.78 ± 4.64 days, P = 0.049). There was no statistically significant difference between CSD and non-CSD groups within 1 month after the ORIF regarding blood loss, period of wound oozing, and postoperative complications, such as incidence of wound infection, haematoma, erythema, dehiscence, and lower limb DVT.
CONCLUSION


Prophylactic CSD after primary ORIF for closed distal femur fractures not only had no significant advantage to minimize blood loss and wound complications, but increased local inflammation and postoperative hospital stay, and thus we suggest that prophylactic CSD after primary ORIF for closed distal femur fractures is not recommended for optimized clinical pathways and accelerated recovery.",2020,"However, both the peri-wound skin temperature and wound VAS pain scores did not differ significantly between the two groups on the fifth postoperative day.","['patients after open reduction and internal fixation (ORIF) for closed distal femur fractures', 'Between October 2018 and June 2020, 160 closed distal femur fracture patients who were prepared for ORIF were prospectively randomized into two groups: a CSD group with the mean age of 57.91\u2009±\u200914.38\u2009years (32 [40%] men and 48 [60%] women) and a non-CSD group with the mean age of 59.73\u2009±\u200917.55\u2009years (27 [34%] men and 54 [66%] women']","['closed suction drainage (CSD', 'Prophylactic Closed Suction Drainage']","['blood loss, period of wound oozing, and postoperative complications, such as incidence of wound infection, haematoma, erythema, dehiscence, and lower limb DVT', 'longer length of postoperative hospitalization time', 'lower peri-wound skin temperature and wound VAS pain scores', 'Wound visual analogue scale (VAS) pain scores, peri-wound skin temperature, hematocrit (Hct), hemoglobin (Hb) concentrations, hidden blood loss (HBL), dressing change, period of wound oozing, postoperative blood transfusion, and length of postoperative hospital stay', 'local inflammation and postoperative hospital stay', 'Postoperative wound complications, namely wound infections, wound haematoma, wound dehiscence, erythema of wound, and lower limb deep vein thrombosis (DVT', 'peri-wound skin temperature and wound VAS pain scores', 'blood loss and wound complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0015802', 'cui_str': 'Fracture of femur'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0340708', 'cui_str': 'Deep venous thrombosis of lower extremity'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0564444', 'cui_str': 'Wound of skin'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0205262', 'cui_str': 'Occult'}, {'cui': 'C0085671', 'cui_str': 'Change of dressing'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0877305', 'cui_str': 'Postoperative wound complication'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0281860', 'cui_str': 'Wound hematoma'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",160.0,0.0248248,"However, both the peri-wound skin temperature and wound VAS pain scores did not differ significantly between the two groups on the fifth postoperative day.","[{'ForeName': 'Jun-Zhe', 'Initials': 'JZ', 'LastName': 'Zhang', 'Affiliation': 'The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Kuo', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': 'The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Jun-Yong', 'Initials': 'JY', 'LastName': 'Li', 'Affiliation': 'The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Hong-Yu', 'Initials': 'HY', 'LastName': 'Meng', 'Affiliation': 'The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Yan-Bin', 'Initials': 'YB', 'LastName': 'Zhu', 'Affiliation': 'The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Ying-Ze', 'Initials': 'YZ', 'LastName': 'Zhang', 'Affiliation': 'The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}]",Orthopaedic surgery,['10.1111/os.12812']
2316,33047511,Occurrence of postdural puncture headache-A randomized controlled trial comparing 22G Sprotte and Quincke.,"OBJECTIVE


To assess the incidence of postdural puncture headache (PDPH) using 22-gauge atraumatic needle (Sprotte, 22GS) compared with 22-gauge traumatic needle (Quincke, 22GQ).
BACKGROUND


Diagnostic lumbar puncture (dLP) is commonly complicated by PDPH. Despite evidence to support the use of 22GS, European neurologists seem to keep using 22GQ.
METHODS


This was a randomized, double-blind study. Adults (age: 18-60 years) scheduled for dLP were included. dLP and CSF acquisition were performed in accordance with highly standardized procedures. Patients were followed up on days 2 and 7.
RESULTS


In total, 172 patients were randomized and lumbar punctured, and 21 were excluded due to wrong inclusion (n = 11), needle switch (n = 7), failed dLP (n = 1), withdrawal (n = 1), and missed follow-up (n = 1). Among the remaining 151 patients (mean age: 40.7 ± 12.4 years), 77 had dLP using 22GQ and 74 using 22GS. Incidence of PDPH among patients punctured with 22GS (18%) was significantly lower (p = .004) than among patients punctured with 22GQ (39%). Relative risk was 0.45, 95% CI 0.26-0.80. Patients with PDPH had significantly lower weight (p = .035), and there was no significant difference related to age (p = .064), sex (p = .239), height (p = .857), premorbid episodic migraine (p = .829), opening pressure (p = .117), operators (p = .148), amount of CSF removed (p = .205), or number of attempts (p = .623).
CONCLUSIONS


The use of 22GS halves the risk of PDPH compared with 22GQ. This study provides strong support to make a change in practice where traumatic needles are still in regular use.",2020,Incidence of PDPH among patients punctured with 22GS (18%) was significantly lower (p = .004) than among patients punctured with 22GQ (39%).,"['Adults (age: 18-60\xa0years) scheduled for', '172 patients were randomized and lumbar punctured, and 21 were excluded due to wrong inclusion (n\xa0=\xa011), needle switch (n\xa0=\xa07', 'remaining 151 patients (mean age: 40.7\xa0±\xa012.4\xa0years), 77 had dLP using 22GQ and 74 using 22GS']","['failed dLP', '22-gauge atraumatic needle (Sprotte, 22GS', 'Diagnostic lumbar puncture (dLP', '22-gauge traumatic needle (Quincke, 22GQ', 'dLP']","['opening pressure', 'lower weight', 'Incidence of PDPH', 'premorbid episodic migraine', 'postdural puncture headache (PDPH', 'postdural puncture headache']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0553794', 'cui_str': 'Diagnostic lumbar puncture'}]","[{'cui': 'C0553794', 'cui_str': 'Diagnostic lumbar puncture'}, {'cui': 'C0450404', 'cui_str': '22G'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0002994', 'cui_str': 'Angioedema'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0751188', 'cui_str': 'Post dural puncture headache'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}]",172.0,0.216111,Incidence of PDPH among patients punctured with 22GS (18%) was significantly lower (p = .004) than among patients punctured with 22GQ (39%).,"[{'ForeName': 'Ane Skaare', 'Initials': 'AS', 'LastName': 'Sjulstad', 'Affiliation': 'Nordland Hospital Trust, Bodø, Norway.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Odeh', 'Affiliation': 'Nordland Hospital Trust, Bodø, Norway.'}, {'ForeName': 'Farid K', 'Initials': 'FK', 'LastName': 'Baloch', 'Affiliation': 'Nordland Hospital Trust, Bodø, Norway.'}, {'ForeName': 'Diana Hristova', 'Initials': 'DH', 'LastName': 'Berg', 'Affiliation': 'Nordland Hospital Trust, Bodø, Norway.'}, {'ForeName': 'Kathrine', 'Initials': 'K', 'LastName': 'Arntzen', 'Affiliation': 'Nordland Hospital Trust, Bodø, Norway.'}, {'ForeName': 'Karl B', 'Initials': 'KB', 'LastName': 'Alstadhaug', 'Affiliation': 'Nordland Hospital Trust, Bodø, Norway.'}]",Brain and behavior,['10.1002/brb3.1886']
2317,33047550,The interactive effect of preoperative consultation and operating room admission by a counselor on anxiety level and vital signs in patients undergoing Coronary Artery Bypass Grafting surgery. A clinical trial study.,"OBJECTIVES


The purpose of this study was to provide appropriate preoperative supportive conditions to improve anxiety and vital signs for patients undergoing Coronary Artery Bypass Grafting -CABG- surgery.
METHODS


This clinical trial study was performed on 90 patients undergoing CABG surgery in Farshchian Hospital of Hamadan, Iran in 2019. Sample was selected by convenience and were randomly divided into three groups: control (n=30), intervention1 (n=30), and intervention2 (n=30). The control group received only the routine preoperative counseling of ward and admitted to the operating room as usual; the intervention1 and intervention2 groups in addition received another two counseling sessions, then the intervention1 group was admitted in the operating room as usual, but the intervention2 group was admitted by the counselor in the operating room. Data were collected using a three-part questionnaire including demographic characteristics, vital signs chart, and the Spielberger's State-Trait Anxiety Inventory.
RESULTS


The results showed that there was a significant difference in the mean anxiety of the three groups after admission in the operating room (intervention2 was lower than intervention1 and control groups, p<0.001; and intervention 1 group was lower than control group, p<0.001) and also there was a significant difference between the mean systolic blood pressure, heart rate and respiratory rate of the three groups (p <0.001) but the mean of the variables of temperature and diastolic blood pressure in the three groups were not significantly different (p=0.59 and p=0.225, respectively).
CONCLUSIONS


Our results revealed preoperative consultation and admission in the operating room by the consultant can reduce the level of anxiety and stability of vital signs of patients undergoing CABG.",2020,"The results showed that there was a significant difference in the mean anxiety of the three groups after admission in the operating room (intervention2 was lower than intervention1 and control groups, p<0.001; and intervention 1 group was lower than control group, p<0.001) and also there was a significant difference between the mean systolic blood pressure, heart rate and respiratory rate of the three groups (p <0.001) but the mean of the variables of temperature and diastolic blood pressure in the three groups were not significantly different (p=0.59 and p=0.225, respectively).
","['90 patients undergoing CABG surgery in Farshchian Hospital of Hamadan, Iran in 2019', 'patients undergoing Coronary Artery Bypass Grafting -CABG- surgery', 'patients undergoing Coronary Artery Bypass Grafting surgery']","['routine preoperative counseling of ward and admitted to the operating room as usual; the intervention1 and intervention2 groups in addition received another two counseling sessions', 'preoperative consultation and operating room admission by a counselor']","['anxiety level and vital signs', 'temperature and diastolic blood pressure', 'mean systolic blood pressure, heart rate and respiratory rate', 'anxiety and vital signs', 'mean anxiety', 'level of anxiety and stability of vital signs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0920638', 'cui_str': 'Preoperative counseling'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",90.0,0.0157657,"The results showed that there was a significant difference in the mean anxiety of the three groups after admission in the operating room (intervention2 was lower than intervention1 and control groups, p<0.001; and intervention 1 group was lower than control group, p<0.001) and also there was a significant difference between the mean systolic blood pressure, heart rate and respiratory rate of the three groups (p <0.001) but the mean of the variables of temperature and diastolic blood pressure in the three groups were not significantly different (p=0.59 and p=0.225, respectively).
","[{'ForeName': 'Zandi', 'Initials': 'Z', 'LastName': 'Shirdel', 'Affiliation': 'Hamadan University of Medical Sciences, Hamadan, Iran, shirdel.zandi1994@yahoo.com.'}, {'ForeName': 'Imani', 'Initials': 'I', 'LastName': 'Behzad', 'Affiliation': 'Hamadan University of Medical Sciences, Hamadan, Iran, behzadiman@yahoo.com.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Manafi', 'Affiliation': 'Hamadan University of Medical Sciences, Hamadan, Iran, manafi@umsha.ac.ir.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Saheb', 'Affiliation': 'Hamadan University of Medical Sciences, Hamadan, Iran, Mahdi.Sahebi1415@yahoo.com.'}]",Investigacion y educacion en enfermeria,['10.17533/udea.iee.v38n2e07']
2318,33047586,[Appendectomy technique: paradigm shift or a well-forgotten old one? The role of mesoappendectomy in prevention of infectious intra-abdominal complications (announcement of RCT)].,"OBJECTIVE


To analyze the role of mesoappendixectomy in the development of intra-abdominal surgical site infection (IAB SSI) after LAE.
MATERIAL AND METHODS


A prospective randomized non-blind multiple-center registered (ClinicalTrials.gov NCT03754777) study has been performed for the period from 2016 to 2018. The study was devoted to effectiveness and safety of the modified enhanced recovery protocol in LAE. In the main group, this protocol ( n =56) included routine mesoappendixectomy, restrictive strategy for abdominal drainage and postoperative antibiotic prevention. In the control group ( n =71), mesoappendixectomy was performed only in case of necrotic changes. Both groups were comparable by demographic parameters and severity of comorbidities.
RESULTS


In the main group, significant decrease in the incidence of IAB SSI was found (0% versus 9.8%). Moreover, the main group was characterized by reduced length of hospital-stay (1.43±1.34 d versus 2.94±2, 43 days).
CONCLUSION


Mesoappendixectomy should be evaluated in further research as a potential factor in prevention of IAB SSI.",2020,"In the main group, significant decrease in the incidence of IAB SSI was found (0% versus 9.8%).",[],"['mesoappendectomy', 'mesoappendixectomy', 'routine mesoappendixectomy, restrictive strategy for abdominal drainage and postoperative antibiotic prevention']","['reduced length of hospital-stay', 'incidence of IAB SSI', 'demographic parameters and severity of comorbidities']",[],"[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",,0.0412978,"In the main group, significant decrease in the incidence of IAB SSI was found (0% versus 9.8%).","[{'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Sazhin', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Nechay', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Titkova', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Petukhov', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Tyagunov', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Stradymov', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Ermakov', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'N Yu', 'Initials': 'NY', 'LastName': 'Mishakina', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}]",Khirurgiia,['10.17116/hirurgia202010149']
2319,33047588,[Risk factors of abdominal wound dehiscence in abdominal surgery].,"OBJECTIVE


To evaluate the role of various perioperative risk factors on the incidence of abdominal wound dehiscence.
MATERIAL AND METHODS


A retrospective controlled randomized trial of the risk factors of abdominal wound dehiscence was conducted in 62 patients for the period 2013- 2018. The research was performed at the Perm City Clinical Hospital No. 4. All patients were divided into two groups: the main one ( n =31) with abdominal wound dehiscence in early postoperative period and the control group ( n =31) without this event. Both groups were comparable by gender, age and surgical abdominal diseases. Between-group differences in numerical indicators were analyzed using Mann-Whitney U-test, qualitative variables were analyzed using contingency tables. Differences were significant at  p -value <0.05.
RESULTS


Incidence of abdominal wound dehiscence was similar in patients who admitted in emergency and elective fashion ( p =0.54). Anemia upon admission ( p =0.71), diabetes mellitus type 2 ( p =1.00), COPD ( p =0.13) and obesity ( p =0.76) were not significant predictors of abdominal wound dehiscence. There were significant between-group differences in CRP level ( p =0.04). Among intraoperative risk factors, duration of surgery ( p =0.78), surgical approach ( p =1.00), aponeurosis suturing technique ( p =0.39) and stoma ( p =0.71) did not significantly affect the incidence of abdominal wound dehiscence. In early postoperative period, abdominal wound dehiscence correlated with peritonitis ( p =0.04), SSI ( p <0.01) and redo laparotomy ( p =0.02).
CONCLUSION


Despite the variety of pre-, intra- and postoperative risk factors, only infectious postoperative complications (SSI, peritonitis) and redo surgical interventions influenced the development of abdominal wound dehiscence. Thus, the concept of abdominal wound dehiscence prevention should be inextricably associated with the concept of prevention of postoperative infectious complications from the abdominal wall and abdominal cavity.",2020,"In early postoperative period, abdominal wound dehiscence correlated with peritonitis ( p =0.04), SSI ( p <0.01) and redo laparotomy ( p =0.02).
","['abdominal surgery', '62 patients for the period 2013- 2018']",[],"['redo laparotomy', 'Anemia upon admission', 'aponeurosis suturing technique', 'abdominal wound dehiscence', 'diabetes mellitus type 2', 'abdominal wound dehiscence correlated with peritonitis', 'COPD', 'SSI', 'incidence of abdominal wound dehiscence', 'CRP level']","[{'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0225205', 'cui_str': 'Aponeurosis structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1739397', 'cui_str': 'Abdominal wound dehiscence'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",31.0,0.0224269,"In early postoperative period, abdominal wound dehiscence correlated with peritonitis ( p =0.04), SSI ( p <0.01) and redo laparotomy ( p =0.02).
","[{'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Samartsev', 'Affiliation': 'Wagner Perm State Medical University, Perm, Russia.'}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Gavrilov', 'Affiliation': 'Wagner Perm State Medical University, Perm, Russia.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Kuznetsova', 'Affiliation': 'Wagner Perm State Medical University, Perm, Russia.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Kuznetsova', 'Affiliation': 'Wagner Perm State Medical University, Perm, Russia.'}]",Khirurgiia,['10.17116/hirurgia202010168']
2320,33039291,Electrophysiological testing in chronic inflammatory demyelinating polyneuropathy patients treated with subcutaneous immunoglobulin: The Polyneuropathy And Treatment with Hizentra (PATH) study.,"OBJECTIVE


To assess electrophysiology parameters that can reflect patients' clinical status and show changes in nerve function with treatment, in a study of subcutaneous immunoglobulin in chronic inflammatory demyelinating polyneuropathy.
METHODS


Nerve conduction studies (latency, conduction velocity, conduction block and compound muscle action potential [CMAP] on upper limb median, ulnar, and lower limb peroneal motor nerves) were conducted in the placebo-controlled PATH (Polyneuropathy And Treatment with Hizentra) study of two doses of maintenance subcutaneous immunoglobulin (SCIG) IgPro20 in CIDP.
RESULTS


Averaged proximal latency substantially increased with placebo (+1.1 ms) indicating electrophysiologic deterioration but remained stable with IgPro20 (0.2 g/kg bodyweight [bw]: +0.1 ms; 0.4 g/kg bw: -0.1 ms). Distal latencies were also more prolonged with placebo versus IgPro20. Averaged motor nerve conduction velocity substantially decreased with placebo (-1.6 m/s) versus increasing in both IgPro20 groups (+0.2 m/s and +1.0 m/s, respectively). Conduction block and CMAP amplitudes did not change substantially.
CONCLUSION


These findings support the effectiveness of maintenance IgPro20, as nerve function changed in the direction of increasing nerve dysfunction with placebo but remained stable with ongoing IgPro20 therapy.
SIGNIFICANCE


Electrophysiology testing can support assessment of clinical status in CIDP to determine treatment efficacy.",2020,"Averaged motor nerve conduction velocity substantially decreased with placebo (-1.6 m/s) versus increasing in both IgPro20 groups (+0.2 m/s and +1.0 m/s, respectively).",['chronic inflammatory demyelinating polyneuropathy patients treated with'],"['Electrophysiological testing', 'subcutaneous immunoglobulin', 'placebo', 'maintenance subcutaneous immunoglobulin (SCIG) IgPro20']","['Conduction block and CMAP amplitudes', 'electrophysiologic deterioration', 'Distal latencies', 'Averaged motor nerve conduction velocity', 'proximal latency', 'conduction studies (latency, conduction velocity, conduction block and compound muscle action potential [CMAP] on upper limb median, ulnar, and lower limb peroneal motor nerves']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0270922', 'cui_str': 'Peripheral demyelinating neuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C3181507', 'cui_str': 'IgPro20'}]","[{'cui': 'C0018794', 'cui_str': 'Heart block'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0457379', 'cui_str': 'Motor nerve conduction velocity'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber'}, {'cui': 'C0522028', 'cui_str': 'Muscle action potential'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0442044', 'cui_str': 'Ulnar'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0442035', 'cui_str': 'Peroneal'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}]",,0.0632605,"Averaged motor nerve conduction velocity substantially decreased with placebo (-1.6 m/s) versus increasing in both IgPro20 groups (+0.2 m/s and +1.0 m/s, respectively).","[{'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Bril', 'Affiliation': 'Ellen and Martin Prosserman Centre for Neuromuscular Diseases, Division of Neurology, Department of Medicine, University Health Network, University of Toronto, Toronto, Canada; Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia. Electronic address: vera.bril@utoronto.ca.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, UKD and Center for Neurology and Neuropsychiatry, LVR Klinikum, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'John-Philip', 'Initials': 'JP', 'LastName': 'Lawo', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Billie L', 'Initials': 'BL', 'LastName': 'Durn', 'Affiliation': 'CSL Behring, King of Prussia, PA, USA.'}, {'ForeName': 'Orell', 'Initials': 'O', 'LastName': 'Mielke', 'Affiliation': 'CSL Behring, Marburg, Germany.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.09.001']
2321,33039300,"The Effectiveness of Using a Nurse-Led Pain Relief Model for Pain Management among Abdominal Surgical Patients: A Single-Center, Controlled before-after Study in China.","BACKGROUND


Effective pain management is closely related to the prognosis of patients after surgery. Setting up acute pain service is among the effective strategies to control pain. The operation of acute pain service is mostly dominated by anesthesiologists; however, control of postsurgical pain is still unsatisfactory. Nurses are the main force for providing postoperative care of patients, and their role in acute pain service is crucial. Therefore, in the current study, we have developed a nurse-led pain relief model that emphasizes the central role of nurses during the entire surgical procedure. However, the effect of using this model for pain management among abdominal surgical patients remains unknown.
AIMS


The current study was conducted to investigate the effect of using a nurse-led pain relief model for pain management among abdominal surgical patients.
DESIGN


A single-center, propensity score-matched, controlled before-after study.
METHODS


The patients, hospitalized for abdominal surgery in a university-affiliated hospital from January 2015 to December 2017, were enrolled and divided into group A (hospitalized before nurse-led pain relief model implementation, from January, 2015 to October, 2016) and group B (hospitalized after nurse-led pain relief model implementation, from October, 2016, to December, 2017) using propensity score match assay. The researchers compared the quality of acute pain management, the main side effects of pain management, and nurses' pain knowledge and attitude between group A and group B.
RESULTS


A total of 2851 patients undergoing nonemergency abdominal surgery were enrolled in the current study and were propensity matched 1:1 into two groups with 1,127 subjects in each group. The quality of acute pain management postsurgery was better after implementation of the nurse-led pain relief model. More patients received higher numerical rating scales cores (≥4 points) at indicated time points after surgery in group A compared with group B (14.20% vs. 12.24% 6 hours postsurgery, p = .001; 12.33% vs. 8.52% 12 hours postsurgery, p = .004; 12.95% vs. 3.99% 24 hours postsurgery, p = .036; 16.06% vs. 7.19% 48 hours postsurgery, p = .001). Furthermore, the occurrence of nausea and vomiting during pain management were significantly decreased in patients from group B (nausea: X 2  = 38.926, p < .05; vomit: X 2  = 39.302, p < .05). Additionally, after using the nurse-led pain relief model, nurses were more open to improving their knowledge and attitudes to pain management (p < .05).
CONCLUSION


Our study demonstrated that a nurse-led pain relief model can enhance the quality of acute pain management among post-abdominal surgical patients, suggesting that such a model can be an effective intervention for providing a better pain control among postsurgical patients.",2020,"More patients received higher numerical rating scales cores (≥4 points) at indicated time points after surgery in group A compared with group B (14.20% vs. 12.24% 6 hours postsurgery,","['pain management among abdominal surgical patients', '2851 patients undergoing nonemergency abdominal surgery were enrolled in the current study and were propensity matched 1:1 into two groups with 1,127 subjects in each group', 'Abdominal Surgical Patients', 'post-abdominal surgical patients', 'abdominal surgical patients', 'patients, hospitalized for abdominal surgery in a university-affiliated hospital from January 2015 to December 2017, were enrolled and divided into group A (hospitalized before nurse-led pain relief model implementation, from January, 2015 to October, 2016) and group B (hospitalized after nurse-led pain relief model implementation, from October, 2016, to December, 2017) using propensity score match assay']","['nurse-led pain relief model', 'Nurse-Led Pain Relief Model']","['numerical rating scales cores', 'knowledge and attitudes to pain management', 'nausea and vomiting during pain management']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",2851.0,0.0392916,"More patients received higher numerical rating scales cores (≥4 points) at indicated time points after surgery in group A compared with group B (14.20% vs. 12.24% 6 hours postsurgery,","[{'ForeName': 'Liangyu', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'Department of Anesthesiology, School of Medicine, The Second Affiliated Hospital of Zhejiang University, Hangzhou, China. Electronic address: a88513103@163.com.'}, {'ForeName': 'Laijuan', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, School of Medicine, The Second Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Hongling', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Specialist Nursing, School of Medicine, The Second Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yinchuan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, School of Medicine, The Second Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jingfeng', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Department of Nursing, School of Medicine, The Second Affiliated Hospital of Zhejiang University, Hangzhou, China.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2020.08.004']
2322,33039302,Early rehabilitation during extracorporeal membrane oxygenation has minimal impact on physiological parameters: A pilot randomised controlled trial.,"BACKGROUND


Patients on extracorporeal membrane oxygenation (ECMO) often require prolonged periods of bed rest owing to their severity of illness along with the care required to maintain the position and integrity of the ECMO cannula. Many patients on ECMO receive passive exercises, and rehabilitation is often delayed owing to medical instability, with a high proportion of patients demonstrating severe muscle weakness. The physiological effects of an intensive rehabilitation program started early after ECMO commencement remain unknown.
OBJECTIVES


The primary objective of this study was to describe the respiratory and haemodynamic effects of early intensive rehabilitation compared with standard care physiotherapy over a 7-d period in patients requiring ECMO.
METHODS


This was a physiological substudy of a multicentre randomised controlled trial conducted in one tertiary referral hospital. Consecutive adult patients undergoing ECMO were recruited. Respiratory and haemodynamic parameters, along with ECMO settings, were recorded 30 min before and after each session and continuously during the session. In addition, the minimum and maximum values for these parameters were recorded outside of the rehabilitation or standard care sessions for each 24-h period over the 7 d. The number of minutes of exercise per session was recorded.
RESULTS


Fifteen patients (mean age = 51.5 ± standard deviation of 14.3 y, 80% men) received ECMO. There was no difference between the groups for any of the respiratory, haemodynamic, or ECMO parameters. The minimum and maximum values for each parameter were recorded outside of the rehabilitation or standard care sessions. The intensive rehabilitation group (n = 7) spent more time exercising per session than the standard care group (n = 8) (mean = 28.7 versus 4.2 min, p < 0.0001). Three patients (43%) in the intensive rehabilitation group versus none in the standard care group mobilised out of bed during ECMO.
CONCLUSIONS


In summary, early intensive rehabilitation of patients on ECMO had minimal effect on physiological parameters.",2020,"Three patients (43%) in the intensive rehabilitation group versus none in the standard care group mobilised out of bed during ECMO.
","['Consecutive adult patients undergoing ECMO were recruited', 'patients requiring ECMO', 'Fifteen patients (mean age\xa0=\xa051.5\xa0±\xa0standard deviation of 14.3']","['extracorporeal membrane oxygenation (ECMO', 'standard care physiotherapy', 'intensive rehabilitation group (n\xa0=\xa07) spent more time exercising per session than the standard care group (n\xa0=\xa08) (mean\xa0', 'early intensive rehabilitation', 'extracorporeal membrane oxygenation', 'ECMO', 'intensive rehabilitation', 'intensive rehabilitation program']","['respiratory, haemodynamic, or ECMO parameters', 'number of minutes of exercise per session']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]","[{'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1562039', 'cui_str': 'Number of minutes'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0600302,"Three patients (43%) in the intensive rehabilitation group versus none in the standard care group mobilised out of bed during ECMO.
","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hayes', 'Affiliation': 'Department of Physiotherapy, Alfred Health, Victoria, Australia; Discipline of Physiotherapy, La Trobe University, Victoria, Australia. Electronic address: k.hayes@alfred.org.au.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Holland', 'Affiliation': 'Department of Physiotherapy, Alfred Health, Victoria, Australia; Monash University and Alfred Health, Department of Allergy, Immunology and Respiratory Medicine, Victoria, Australia. Electronic address: a.holland@alfred.org.au.'}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Pellegrino', 'Affiliation': 'Intensive Care Unit, Alfred Health, Victoria, Australia. Electronic address: v.pellegrino@alfred.org.au.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Young', 'Affiliation': 'Intensive Care Unit, Alfred Health, Victoria, Australia. Electronic address: m.young@alfred.org.au.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Paul', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Victoria, Australia. Electronic address: eldho.paul@monash.edu.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Hodgson', 'Affiliation': 'Department of Physiotherapy, Alfred Health, Victoria, Australia; Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Victoria, Australia. Electronic address: carol.hodgson@monash.edu.'}]",Australian critical care : official journal of the Confederation of Australian Critical Care Nurses,['10.1016/j.aucc.2020.07.008']
2323,33039316,Impact of an Educational Pamphlet on Knowledge About Health Risks After Hypertensive Disorders of Pregnancy: A Randomized Trial.,"OBJECTIVE


To evaluate patients' knowledge, risk perception, and anxiety about future health risks after an episode of hypertensive disorder of pregnancy (HDP), as well as their satisfaction with an educational pamphlet.
METHODS


From January 2016 to June 2017, participants were randomly assigned to one of 2 groups and asked to complete questionnaire #1 (demographics, knowledge, risk perception, anxiety, and satisfaction) after receiving medical counselling at the HDP postpartum clinic. Participants in the intervention group then received the educational pamphlet. One month later, both groups completed the questionnaire again (questionnaire #2). The primary outcome of this study was improvement in the global knowledge score at 1 month, reflecting improved understanding of the health risks of HDP. Secondary outcomes included retention of information, risk perception, satisfaction, and anxiety level.
RESULTS


Of 137 eligible women, 57 were randomly assigned to the intervention group and 56, to the control group. Participants in both groups had similar baseline characteristics. Thirteen percent of participants did not complete questionnaire #2. The knowledge score was higher in the intervention group than the control group at 1 month, (88.2%; 95% confidence interval [CI] 26.37-28.32 and 71.3%; 95% CI 20.78-23.45, respectively [P <0.0001]). No difference was seen in anxiety level between the groups (4.0 ± 1.00 vs. 3.8 ± 0.92; P = 0.6746). The intervention group was highly satisfied with the medical counselling they received (5.5 ± 0.84 out 6) and with the pamphlet (5.6 ± 0.66 out 6).
CONCLUSION


The educational pamphlet increased women's knowledge about future health risks of HDP without increasing anxiety and it may be helpful in promoting lifestyle changes necessary to modify these risks.",2020,"The knowledge score was higher in the intervention group than the control group at 1 month, (88.2%; 95% confidence interval [CI] 26.37-28.32 and 71.3%; 95% CI 20.78-23.45, respectively [P <0.0001]).","['After Hypertensive Disorders of Pregnancy', '137 eligible women', 'From January 2016 to June 2017, participants']","['educational pamphlet', 'Educational Pamphlet']","['global knowledge score at 1 month, reflecting improved understanding of the health risks of HDP', 'retention of information, risk perception, satisfaction, and anxiety level', 'knowledge score', 'anxiety level']","[{'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",137.0,0.0762836,"The knowledge score was higher in the intervention group than the control group at 1 month, (88.2%; 95% confidence interval [CI] 26.37-28.32 and 71.3%; 95% CI 20.78-23.45, respectively [P <0.0001]).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Parfenova', 'Affiliation': ""Obstetric Medicine, Division of General Internal Medicine, Department of Medicine, CIUSSS de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke, Université de Sherbrooke, Sherbrooke, QC. Electronic address: maria.parfenova@usherbrooke.ca.""}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Côté', 'Affiliation': ""Nephrology and Obstetric Medicine, Department of Medicine, CIUSSS de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke, Université de Sherbrooke, Sherbrooke, QC.""}, {'ForeName': 'Annabelle', 'Initials': 'A', 'LastName': 'Cumyn', 'Affiliation': ""Obstetric Medicine, Division of General Internal Medicine, Department of Medicine, CIUSSS de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke, Université de Sherbrooke, Sherbrooke, QC.""}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Pesant', 'Affiliation': ""Endocrinology, Department of Medicine, CIUSSS de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke, Université de Sherbrooke, Sherbrooke, QC.""}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Champagne', 'Affiliation': ""Perinatology, Department of Family Medicine, CIUSSS de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC.""}, {'ForeName': 'Marie-Ève', 'Initials': 'MÈ', 'LastName': 'Roy-Lacroix', 'Affiliation': ""Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, CIUSSS de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke, Université de Sherbrooke, Sherbrooke, QC.""}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Malick', 'Affiliation': ""Department of Medicine, CIUSSS de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke, Université de Sherbrooke, Sherbrooke, QC.""}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Sauvé', 'Affiliation': ""Obstetric Medicine, Division of General Internal Medicine, Department of Medicine, CIUSSS de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke, Université de Sherbrooke, Sherbrooke, QC.""}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2020.07.008']
2324,33039321,Promoting fertility awareness and preconception health using a chatbot: a randomized controlled trial.,"RESEARCH QUESTION


What are the effects of using a fertility education chatbot, i.e. automatic conversation programme, on knowledge, intentions to improve preconception behaviour and anxiety?
DESIGN


A three-armed, randomized controlled trial was conducted using an online social research panel. Participants included 927 women aged 20-34 years who were randomly allocated to one of three groups: a fertility education chatbot (intervention group), a document about fertility and preconception health (control group 1) or a document about an irrelevant topic (control group 2). Participants' scores on the Cardiff Fertility Knowledge Scale and the State-Trait Anxiety Inventory, their intentions to optimize preconception behaviours, e.g. taking folic acid, and the free-text feedback provided by chatbot users were assessed.
RESULTS


A repeated-measures analysis of variance showed significant fertility knowledge gains after the intervention in the intervention group (+9.1 points) and control group 1 (+14.9 points) but no significant change in control group 2 (+1.1 points). Post-test increases in the intentions to optimize behaviours were significantly higher in the intervention group than in control group 2, and were similar to those in control group 1. Post-test state anxiety scores were significantly lower in the intervention group than in control group 1 and control group 2. User feedbacks about the chatbot suggested technical limitations, e.g. low comprehension of users' words, and pros and cons of using the chatbot, e.g. convenient versus coldness.
CONCLUSIONS


Providing fertility education using a chatbot improved fertility knowledge and intentions to optimize preconception behaviour without increasing anxiety, but the improvement in knowledge was small. Further technical development and exploration of personal affinity for technology is required.",2020,"CONCLUSIONS


Providing fertility education using a chatbot improved fertility knowledge and intentions to optimize preconception behaviour without increasing anxiety, but the improvement in knowledge was small.",['Participants included 927 women aged 20-34 years'],"['fertility education chatbot (intervention group), a document about fertility and preconception health (control group 1) or a document about an irrelevant topic (control group 2']","['intentions to optimize behaviours', 'Cardiff Fertility Knowledge Scale and the State-Trait Anxiety Inventory, their intentions to optimize preconception behaviours, e.g. taking folic acid, and the free-text feedback provided by chatbot users', 'fertility knowledge gains', 'Post-test state anxiety scores']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1689849', 'cui_str': 'Fertility education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",927.0,0.0421775,"CONCLUSIONS


Providing fertility education using a chatbot improved fertility knowledge and intentions to optimize preconception behaviour without increasing anxiety, but the improvement in knowledge was small.","[{'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Maeda', 'Affiliation': 'Department of Environmental Health Science and Public Health, Akita University Graduate School of Medicine, Akita 010-8543, Japan. Electronic address: erimaeda@med.akita-u.ac.jp.'}, {'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Miyata', 'Affiliation': 'Reproduction Center, Dokkyo Medical University, Saitama 343-8555, Japan.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Boivin', 'Affiliation': 'Cardiff Fertility Studies Research Group, School of Psychology, Cardiff University, Cardiff CF10 3AT, UK.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Nomura', 'Affiliation': 'Department of Environmental Health Science and Public Health, Akita University Graduate School of Medicine, Akita 010-8543, Japan.'}, {'ForeName': 'Yukiyo', 'Initials': 'Y', 'LastName': 'Kumazawa', 'Affiliation': 'Department of Obstetrics and Gynecology, Akita University Graduate School of Medicine, Akita 010-8543, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Shirasawa', 'Affiliation': 'Department of Obstetrics and Gynecology, Akita University Graduate School of Medicine, Akita 010-8543, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': ""Umegaoka Women's Clinic, Tokyo 154-0022, Japan.""}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Terada', 'Affiliation': 'Department of Obstetrics and Gynecology, Akita University Graduate School of Medicine, Akita 010-8543, Japan.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.09.006']
2325,33039508,Using behavioural insights to reduce sugar in primary school children's packed lunches in Derby; a cluster randomised controlled trial.,"Children's packed lunches contain more sugar than school-provided meals. Interventions to improve the provision of healthier packed lunches have modest effects on lunch contents. This cluster randomised controlled trial tested an intervention to encourage healthier provision of packed lunches by parents of primary school children in Derby. Schools were randomised to intervention (n = 8) or control (n = 9) using blocked random allocation. In the intervention group, parents of children who brought packed lunches to school in years 3-6 (age 7-11 years) received three bundles of materials (including packed lunch planner, shopping list, information on sugar content of popular lunchbox items and suggestions for healthier swap alternatives) in bookbags/lunchboxes over a 4-week period. Control parents received no materials. Photos of lunchbox contents were taken at baseline, immediately post-intervention and at three-month follow-up. A parental survey aimed to assess capability, opportunity and motivation for packing a healthier lunchbox. No intervention effects were observed for primary outcomes (presence and number of sugary snacks or chilled sugary desserts). The intervention had a significant impact on one secondary outcome (increased number of healthier ""swap"" items suggested in intervention materials) immediately post-intervention, but this effect had disappeared at three-month follow-up. No intervention effects were found on survey variables. Parent comments revealed that materials were either received positively (as they reinforced existing behaviours) or negatively (as they were not perceived to be helpful or appropriate). The results of this study suggest that providing educational materials and resources to parents of primary school children in Derby was not sufficient to increase provision of healthier packed lunches. Future research should investigate how behavioural science can support families to improve the nutritional content of primary school children's lunchboxes.",2020,This cluster randomised controlled trial tested an intervention to encourage healthier provision of packed lunches by parents of primary school children in Derby.,"['packed lunches by parents of primary school children in Derby', ""primary school children's packed lunches in Derby"", 'parents of children who brought packed lunches to school in years 3-6 (age 7-11 years) received', ""primary school children's lunchboxes""]","['three bundles of materials (including packed lunch planner, shopping list, information on sugar content of popular lunchbox items and suggestions for healthier swap alternatives) in bookbags/lunchboxes']","['number of healthier ""swap"" items', 'primary outcomes (presence and number of sugary snacks or chilled sugary desserts']","[{'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332302', 'cui_str': 'Brought on by'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0085593', 'cui_str': 'Chill'}, {'cui': 'C0453505', 'cui_str': 'Dessert'}]",,0.0360658,This cluster randomised controlled trial tested an intervention to encourage healthier provision of packed lunches by parents of primary school children in Derby.,"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bunten', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Porter', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK. Electronic address: L.Porter@exeter.ac.uk.'}, {'ForeName': 'Jilla', 'Initials': 'J', 'LastName': 'Burgess-Allen', 'Affiliation': 'Derby City Council, Council House, Corporation Street, Derby, DE1 2FS, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Howell-Jones', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Jackson', 'Affiliation': 'University of Derby, Kedleston Road, Derby, DE22 1GB, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Ward', 'Affiliation': 'Medical School, University of Lincoln, Brayford Way, Brayford Pool, Lincoln, LN6 7TS, UK; Public Health Division, Adult Care and Community Wellbeing, Lincolnshire County Council, County Offices, Newland, Lincoln, LN1 1YL, UK.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Staples', 'Affiliation': 'University of Derby, Kedleston Road, Derby, DE22 1GB, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Staples', 'Affiliation': 'University of Derby, Kedleston Road, Derby, DE22 1GB, UK.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Rowthorn', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK; Department of Psychology, University of Warwick, Coventry, CV4 7AL.'}, {'ForeName': 'Ayoub', 'Initials': 'A', 'LastName': 'Saei', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'van Schaik', 'Affiliation': 'School of Social Sciences and Law, Teesside University, Campus Heart, Southfield Rd, Middlesbrough, TS1 3BX.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tydeman', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Blair', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'Hugueniot', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Gold', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Chadborn', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}]",Appetite,['10.1016/j.appet.2020.104987']
2326,33039647,TREATABLE TRAITS THAT PREDICT HEALTH STATUS AND TREATMENT RESPONSE IN AIRWAY DISEASE.,"BACKGROUND


A strategy based on the assessment and management of treatable traits (TT) has been proposed as a new paradigm in airway disease. There is a potentially long list of TT with likely different clinical impact.
OBJECTIVE


This study sought to identify TT most strongly associated with poorer health-related quality of life (HRQoL) and treatments that most substantially improved HRQoL.
METHODS


We pooled data from two parallel-group clinical trials of multidimensional assessment and individualised management targeted to TT versus usual care in patients with COPD or severe asthma (intervention N=45; control N=46). Following multidimensional assessment, 22 TT were identified and the intervention group received treatments tailored to their identified TT. We used Bayesian Model Averaging to examine associations between TT and HRQoL (St George's Respiratory Questionnaire) at baseline, as well as between each TT treatment and the observed change in HRQoL post-intervention.
RESULTS


TT most substantially associated with poorer baseline HRQoL were frequent chest infections, breathing pattern disorder, inadequate inhaler technique, systemic inflammation (C-reactive protein>3mg/L) and depression. In both trials, TT treatment led to a large, significant improvement in HRQoL compared with usual care (Cohen's d=1.19, p<0.001). Receiving a statin for systemic inflammation and oral corticosteroid for eosinophilic airway inflammation were associated with the largest HRQoL improvements. Treatments for exercise intolerance, anxiety, and obesity were associated with smaller improvements in HRQoL.
CONCLUSION


This study contributes to identifying clinically impactful TT by showing that TT across pulmonary, extrapulmonary and behavioural domains were associated with HRQoL impairment and treatment response.",2020,"In both trials, TT treatment led to a large, significant improvement in HRQoL compared with usual care (Cohen's d=1.19, p<0.001).",['patients with COPD or severe asthma (intervention N=45; control N=46'],['multidimensional assessment and individualised management targeted to TT versus usual care'],"['poorer health-related quality of life (HRQoL', 'chest infections, breathing pattern disorder, inadequate inhaler technique, systemic inflammation (C-reactive protein>3mg/L) and depression', 'HRQoL', ""TT and HRQoL (St George's Respiratory Questionnaire"", 'exercise intolerance, anxiety, and obesity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424551', 'cui_str': 'Impaired exercise tolerance'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",,0.164122,"In both trials, TT treatment led to a large, significant improvement in HRQoL compared with usual care (Cohen's d=1.19, p<0.001).","[{'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Hiles', 'Affiliation': 'Centre of Research Excellence in Severe Asthma and Priority Research Centre for Healthy Lungs, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Gibson', 'Affiliation': 'Centre of Research Excellence in Severe Asthma and Priority Research Centre for Healthy Lungs, University of Newcastle, Callaghan, NSW, Australia; Department of Respiratory and Sleep Medicine, John Hunter Hospital, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Alvar', 'Initials': 'A', 'LastName': 'Agusti', 'Affiliation': 'Respiratory Institute, Hospital Clinic, Universitat de Barcelona, IDIBAPS, CIBERES, Barcelona, Spain.'}, {'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'McDonald', 'Affiliation': 'Centre of Research Excellence in Severe Asthma and Priority Research Centre for Healthy Lungs, University of Newcastle, Callaghan, NSW, Australia; Department of Respiratory and Sleep Medicine, John Hunter Hospital, New Lambton Heights, NSW, Australia. Electronic address: vanessa.mcdonald@newcastle.edu.au.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.09.046']
2327,33039650,"Derepression of glomerular filtration, renal blood flow and antioxidant defence in patients with type 2 diabetes at high-risk of cardiorenal disease.","BACKGROUND


The role of antioxidant status on microvascular blood flow and glomerular filtration (eGFR) in patients with type 2 diabetes and hypertension whose risk of progressive renal disease varies by ethnicity is unknown.
METHODS


Adult, non-Caucasian (n=101) and Caucasian (n=69) patients with type 2 diabetes, hypertension and/or microalbuminuria and an eGFR > 45 mL/min/1.73m 2  were randomised to 400 IU vitamin E and/or 20 ug selenium daily or matching placebo. eGFR (CKD-EPI) was measured at baseline, 3,6 and 12 months and renal blood flow by contrast-enhanced ultrasonography in a sub-group (n=9) at baseline and 3 months by assessing the area under the time intensity curve (TIC). Circulating glutathione peroxidase 3 (GPx-3) activity was measured as a biomarker of oxidative defence status.
RESULTS


The time to change in eGFR was shortest with combined vitamin E and selenium than usual care (5.6 [4.0-7.0] vs 8.9 [6.8-10.9 months]; p=0.006). Area under the TIC was reduced compared to baseline (38.52 [22.41- 90.49] vs 123 [86.98- 367.03]dB.s; P≤0.05 and 347 [175.88- 654.92] vs 928.03 [448.45-1683]dB.s; P≤0.05, respectively] at 3 months suggesting an increase in rate of perfusion. The proportional change in eGFR at 12 months was greater in the group whose GPx-3 activity was above, compared with those below the cohort median (360 U/L) in the non-Caucasian and the Caucasian groups (19.1(12.5 to 25.7] % vs 6.5[-3.5 to 16.5] % and 12.8 [0.7 to 24] % vs 0.2 [-6.1 to 6.5] %). .
CONCLUSION


In these patients with type 2 diabetes and early CKD, antioxidant treatment derepresses renal blood flow and a rise in eGFR correlated directly with GPx-3 activity.
SIGNIFICANCE


Diabetes mellitus is the world's leading cause of end-stage renal disease which has a predilection for black and minor ethnic groups compared with Caucasians. The differences in risk despite the benefits of conventional care may be related to oxidative stress. We found that glomerular filtration and renal blood flow is suppressed when renal function is preserved in high-risk patients with type 2 diabetes. Conventional care supplemented with selenium - the co-factor for glutathione peroxidase-3 (GPx-3) - improves renal blood flow and glomerular filtration in sub-groups with lower host antioxidant defence determined by GPx-3 activity. Circulating GPx-3 activity warrants further investigation as a novel biomarker of reversible haemodynamic changes in early diabetic kidney disease to better enable targeting of renoprotective strategies.",2020,"Area under the TIC was reduced compared to baseline (38.52 [22.41- 90.49] vs 123 [86.98- 367.03]dB.s; P≤0.05 and 347 [175.88- 654.92] vs 928.03 [448.45-1683]dB.s; P≤0.05, respectively] at 3 months suggesting an increase in rate of perfusion.","['patients with type 2 diabetes at high-risk of cardiorenal disease', 'patients with type 2 diabetes and hypertension whose risk of progressive renal disease varies by ethnicity', 'high-risk patients with type 2 diabetes', 'Adult, non-Caucasian (n=101) and Caucasian (n=69) patients with type 2 diabetes, hypertension and/or microalbuminuria and an eGFR > 45 mL/min/1.73m 2', 'Diabetes mellitus']","['selenium daily or matching placebo', 'combined vitamin E and selenium', 'Conventional care supplemented with selenium - the co-factor for glutathione peroxidase-3 (GPx-3) ', '400 IU vitamin E']","['glomerular filtration and renal blood flow', 'renal blood flow and glomerular filtration', 'microvascular blood flow and glomerular filtration (eGFR', 'eGFR (CKD-EPI', 'rate of perfusion', 'Circulating glutathione peroxidase 3 (GPx-3) activity', 'renal blood flow', 'GPx-3 activity', 'proportional change in eGFR', 'time to change in eGFR', 'Derepression of glomerular filtration, renal blood flow and antioxidant defence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0155601', 'cui_str': 'Hypertensive heart AND renal disease'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1436542', 'cui_str': 'GPX3 protein, human'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0232809', 'cui_str': 'Glomerular filtration'}, {'cui': 'C0035070', 'cui_str': 'Circulation, Renal'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C1436542', 'cui_str': 'GPX3 protein, human'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]",,0.0397352,"Area under the TIC was reduced compared to baseline (38.52 [22.41- 90.49] vs 123 [86.98- 367.03]dB.s; P≤0.05 and 347 [175.88- 654.92] vs 928.03 [448.45-1683]dB.s; P≤0.05, respectively] at 3 months suggesting an increase in rate of perfusion.","[{'ForeName': 'Karima', 'Initials': 'K', 'LastName': 'Zitouni', 'Affiliation': 'St Georges University of London, Institute of Infection and Immunity, London, UK.'}, {'ForeName': 'M R C P', 'Initials': 'MRCP', 'LastName': 'Steyn', 'Affiliation': 'St Georges University Hospitals NHS Foundation Trust, Thomas Addison Unit, London, UK.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Lyka', 'Affiliation': 'St Georges University of London, Institute of Biomedical & Medical Education, London, UK.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Kelly', 'Affiliation': 'Kings College London, Analytical, Environmental and Forensic Sciences Department, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cook', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Trace Element Unit, Southampton, UK.'}, {'ForeName': 'Irina Chis', 'Initials': 'IC', 'LastName': 'Ster', 'Affiliation': 'St Georges University of London, Institute of Infection and Immunity, London, UK.'}, {'ForeName': 'Kenneth Anthony', 'Initials': 'KA', 'LastName': 'Earle', 'Affiliation': 'St Georges University Hospitals NHS Foundation Trust, Thomas Addison Unit, London, UK; St Georges University of London, Institute of Biomedical & Medical Education, London, UK.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.10.005']
2328,33039658,Randomised comparison of Enk™ and Manujet™ for emergency tracheal oxygenation with a high-fidelity full-scale simulation.,"BACKGROUND


We aimed to compare time and difficulties of emergency tracheal oxygenation with Enk™ or Manujet™ by anaesthesiologists or intensivists, in a full-scale cannot ventilate and intubate scenario on a SimMan3G™ high-fidelity patient simulator.
METHODS


After ethical committee approval and written informed consent, teams (two to three learners with at least one physician senior) participating at a difficult airway training with a massive sublingual haematoma scenario, were randomised in Enk™ (E) group (29 teams, 76 learners) and Manujet™ (M) group (31 teams, 84 learners) according to device at disposal. Main criterion was time between taking device in hand and first insufflation delay. Data were medians [25 - 75%].
RESULTS


The handling-insufflation time was shorter with Enk™ than with Manujet™ (74 [54-87] s versus 95 [73-123] seconds (s), P=0.0112). The team number performing insufflation within one minute after device handling was higher in the E group (8, 27.6%) than in the M group (6.4, %) (P=0.0392) as well as the team number performing insufflation within 90 s in the E group (22, 75.09%) than in the M group (12, 38.7%) (P=0.0047). In E group, 75% of learners reported no difficulty versus 58.8% in M group (P=0.0443). Insufflation frequency was high in both groups and higher than 12/minute in 51.7% of the teams.
CONCLUSION


In a simulation context, Enk™ use is faster and easier. A high insufflation rate was also in favor of Enk™ that generates lower airway pressures.",2020,"In E group, 75% of learners reported no difficulty versus 58.8% in M group (P=0.0443).",['teams (two to three learners with at least one physician senior) participating at a difficult airway training with a massive sublingual haematoma scenario'],"['emergency tracheal oxygenation with Enk™ or Manujet™ by anaesthesiologists or intensivists', 'Enk™ and Manujet™ for emergency tracheal oxygenation']","['Insufflation frequency', 'handling-insufflation time']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}]","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C2945595', 'cui_str': 'Tracheal'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]","[{'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018578', 'cui_str': 'Handling (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0795779,"In E group, 75% of learners reported no difficulty versus 58.8% in M group (P=0.0443).","[{'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Lejus-Bourdeau', 'Affiliation': ""Service d'Anesthésie Réanimation Chirurgicale, Hôtel Dieu-Hôpital Mère Enfant, CHU Nantes, Place Alexis Ricordeau, F-44093 Nantes; Laboratoire Expérimental de Simulation de Médecine Intensive de l'Université (LE SiMU) de Nantes, 9, rue Bias, 44001 Nantes. Electronic address: corinne.lejus@chu-nantes.fr.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Grillot', 'Affiliation': ""Service d'Anesthésie Réanimation Chirurgicale, Hôtel Dieu-Hôpital Mère Enfant, CHU Nantes, Place Alexis Ricordeau, F-44093 Nantes; Laboratoire Expérimental de Simulation de Médecine Intensive de l'Université (LE SiMU) de Nantes, 9, rue Bias, 44001 Nantes.""}, {'ForeName': 'Ségolène', 'Initials': 'S', 'LastName': 'Dupont', 'Affiliation': ""Service d'Anesthésie Réanimation Chirurgicale, Hôtel Dieu-Hôpital Mère Enfant, CHU Nantes, Place Alexis Ricordeau, F-44093 Nantes; Laboratoire Expérimental de Simulation de Médecine Intensive de l'Université (LE SiMU) de Nantes, 9, rue Bias, 44001 Nantes.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Robert-Edan', 'Affiliation': ""Service d'Anesthésie Réanimation Chirurgicale, Hôtel Dieu-Hôpital Mère Enfant, CHU Nantes, Place Alexis Ricordeau, F-44093 Nantes; Laboratoire Expérimental de Simulation de Médecine Intensive de l'Université (LE SiMU) de Nantes, 9, rue Bias, 44001 Nantes.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bazin', 'Affiliation': ""Laboratoire Expérimental de Simulation de Médecine Intensive de l'Université (LE SiMU) de Nantes, 9, rue Bias, 44001 Nantes.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Viquesnel', 'Affiliation': ""Laboratoire Expérimental de Simulation de Médecine Intensive de l'Université (LE SiMU) de Nantes, 9, rue Bias, 44001 Nantes; Pôle Anesthésie Réanimation, CHU Rennes, 2, rue Henri Le Guilloux, 35033 Rennes cedex 9.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Pichenot', 'Affiliation': ""Service d'Anesthésie Réanimation Chirurgicale, Hôtel Dieu-Hôpital Mère Enfant, CHU Nantes, Place Alexis Ricordeau, F-44093 Nantes; Laboratoire Expérimental de Simulation de Médecine Intensive de l'Université (LE SiMU) de Nantes, 9, rue Bias, 44001 Nantes.""}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2020.01.011']
2329,33039944,"Shorter infusion time of ocrelizumab: Results from the randomized, double-blind ENSEMBLE PLUS substudy in patients with relapsing-remitting multiple sclerosis.","BACKGROUND


Ocrelizumab is an approved intravenously administered anti-CD20 antibody for multiple sclerosis (MS). Shortening the 600 mg infusion to 2 hours reduces the total site stay from 5.5-6 hours (approved infusion duration including mandatory pre-medication and post-infusion observation) to 4 hours. The safety profile of shorter-duration ocrelizumab infusions was investigated using results from ENSEMBLE PLUS.
METHODS


ENSEMBLE PLUS is a randomized, double-blind substudy to the single-arm ENSEMBLE study (NCT03085810). In ENSEMBLE, patients with early-stage relapsing-remitting MS received ocrelizumab 600 mg infusions every 24 weeks for 192 weeks. In ENSEMBLE PLUS, ocrelizumab 600 mg administered over the approved 3.5-hour infusion time (conventional duration) is compared with a 2-hour infusion (shorter duration); the durations of the initial infusions (2×300 mg, 14 days apart) were unaffected. The primary endpoint was the proportion of patients with infusion-related reactions (IRRs) following the first Randomized Dose.
RESULTS


From November 1, 2018, to December 13, 2019, 745 patients were randomized 1:1 to the conventional or shorter infusion group. At the first Randomized Dose, 99/373 patients (26.5%) in the conventional and 107/372 patients (28.8%) in the shorter infusion group experienced IRRs. The majority of IRRs were mild or moderate; >99% of all IRRs resolved without sequelae in both groups (conventional infusion group, 99/99; shorter infusion group, 106/107). No IRRs were serious, life-threatening, or fatal. No IRR-related discontinuations occurred. During the first Randomized Dose, 22/373 (5.9%) and 39/372 (10.5%) patients in the conventional and shorter infusion groups, respectively, had IRRs leading to infusion slowing/interruption. Adverse events were consistent with the known safety profile of ocrelizumab.
CONCLUSION


The rates and severity of IRRs were similar between conventional and shorter infusions. No new safety signals were detected. Shortening the infusion time to 2 hours reduces the total site stay time (including mandatory pre-medication/infusion/observation) from 5.5-6 hours to 4 hours, and may reduce patient and site staff burden. A short video summarizing the key results is provided in supplemental material.",2020,"The majority of IRRs were mild or moderate; >99% of all IRRs resolved without sequelae in both groups (conventional infusion group, 99/99; shorter infusion group, 106/107).","['patients with relapsing-remitting multiple sclerosis', 'patients with early-stage relapsing-remitting MS', 'From November 1, 2018, to December 13, 2019, 745 patients']","['ocrelizumab', 'PLUS', 'conventional or shorter infusion group']","['total site stay', 'total site stay time', 'proportion of patients with infusion-related reactions (IRRs', 'rates and severity of IRRs', 'Adverse events', 'serious, life-threatening, or fatal', 'IRRs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]",745.0,0.20051,"The majority of IRRs were mild or moderate; >99% of all IRRs resolved without sequelae in both groups (conventional infusion group, 99/99; shorter infusion group, 106/107).","[{'ForeName': 'H-P', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, UKD, Center of Neurology and Neuropsychiatry and LVR-Klinikum, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany. Electronic address: hans-peter.hartung@uni-duesseldorf.de.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Neurology, Medical University of Vienna, Währinger Gürtel 18-20 1090 Vienna, Austria.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Bermel', 'Affiliation': 'Mellen Center for MS, Neurological Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH44195, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Brochet', 'Affiliation': 'INSERM U 1215, Neurocentre Magendie, University of Bordeaux, Bordeaux, France.'}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Carroll', 'Affiliation': 'Department of Neurology, Sir Charles Gairdner Hospital, Perron Institute for Neurological and Translational Science, The University of Western Australia, Nedlands 6009, Australia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Holmøy', 'Affiliation': 'Department of Neurology, Akershus University Hospital, PO Box 1000, 1478 Lørenskog, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Karabudak', 'Affiliation': 'Department of Neurology, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Killestein', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Neurology, MS Center Amsterdam, Amsterdam Neuroscience, Amsterdam, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nos', 'Affiliation': ""Centre d'Esclerosi Mútiple de Catalunya (Cemcat), Vall d'Hebron Hospital Universitari, 08035, Barcelona, Spain.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Patti', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies, GF Ingrassia, Neuroscience Section and Multiple Sclerosis Center, University of Catania PO Policlinico G Rodolico, Via Santa Sofia, 78 95123 Catania - Italy.'}, {'ForeName': 'A Perrin', 'Initials': 'AP', 'LastName': 'Ross', 'Affiliation': 'Loyola University Chicago, Chicago, Maywood, IL 60660, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vanopdenbosch', 'Affiliation': 'Department of Neurology, AZ Sint Jan Brugge Oostende, Ruddershove 10, 8000, Brugge, Belgium.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vollmer', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, 12631 East 17th St, Mail Stop B 182, Aurora, Colorado 80045, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Buffels', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Garas', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kadner', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Manfrini', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102492']
2330,33039988,Can children swallow tablets? Outcome data from a feasibility study to assess the acceptability of different-sized placebo tablets in children (creating acceptable tablets (CAT)).,"OBJECTIVE


Feasibility study to investigate the acceptability of different-sized placebo tablets in children aged 4-12 years.
DESIGN AND SETTING


Clinical Research Facilities, inpatient wards and outpatient clinics within a Regional Paediatric Hospital and/or District General Hospital. Healthy children and National Health Service (NHS) patients were asked to swallow three placebo tablets: 6 mm, 8 mm and 10 mm, smallest to largest. The researcher observed children's facial expressions and behaviours on swallowing and measured the volume of water consumed. Participants completed a questionnaire about the overall acceptability; including swallowability, taste and volume of water consumed. For analysis, participants were stratified by age: 4-8 years and 9-12 years.
RESULTS


The feasibility study led to an estimated recruitment rate of 0.8% for NHS inpatients and 211 healthy children over a 1-year period. In total, 55 participants were recruited, 30 to the younger group, of which 77% had never taken a tablet before. 84% of the 25 older children had previously taken a tablet. All participants attempted to swallow the smallest sized tablet. The children aged 4-8 years found the larger tablets easier to swallow, however the older children found little difference between the tablet sizes. The younger children required more water to swallow each tablet size compared with the older children where an increasing volume of water was consumed as tablet size increased. Taste was rated highly for both age groups. The 8 mm tablets were deemed the most acceptable tablet size by all participants.
CONCLUSION


Tablets are potentially an acceptable formulation for children aged 4-12 years. Most children aged 4-8 years who attempted to swallow tablets successfully did so. Recruitment of NHS inpatients to medicine acceptability studies is challenging, however, recruitment of children of staff proved an effective strategy. Valuable lessons have been learnt from this feasibility study which will inform the design of a larger definitive trial.",2020,"The children aged 4-8 years found the larger tablets easier to swallow, however the older children found little difference between the tablet sizes.","['participants were stratified by age: 4-8 years and 9-12 years', 'Clinical Research Facilities, inpatient wards and outpatient clinics within a Regional Paediatric Hospital and/or District General Hospital', 'inpatients and 211 healthy children over a 1-year period', 'Most children aged 4-8\u2009years who attempted to swallow tablets successfully did so', 'children (creating acceptable tablets (CAT', '25 older children', 'children aged 4-12 years', 'Healthy children and National Health Service (NHS) patients', '55 participants were recruited, 30 to the younger group, of which 77% had never taken a tablet before']","['NHS', 'placebo tablets']","[""children's facial expressions and behaviours on swallowing"", 'swallowability, taste and volume of water consumed']","[{'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]",55.0,0.202116,"The children aged 4-8 years found the larger tablets easier to swallow, however the older children found little difference between the tablet sizes.","[{'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Bracken', 'Affiliation': ""Paediatric Medicines Research Unit, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McDonough', 'Affiliation': ""Paediatric Medicines Research Unit, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Ashleigh', 'Affiliation': ""NIHR Alder Hey Clinical Research Facility, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Wilson', 'Affiliation': ""NIHR Alder Hey Clinical Research Facility, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Shakeshaft', 'Affiliation': ""Paediatric Medicines Research Unit, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Udeme', 'Initials': 'U', 'LastName': 'Ohia', 'Affiliation': ""NIHR Alder Hey Clinical Research Facility, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Punam', 'Initials': 'P', 'LastName': 'Mistry', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Huw', 'Initials': 'H', 'LastName': 'Jones', 'Affiliation': 'Pediatric Services, Quotient Sciences, Nottingham, UK.'}, {'ForeName': 'Nazim', 'Initials': 'N', 'LastName': 'Kanji', 'Affiliation': 'Pediatric Services, Quotient Sciences, Nottingham, UK.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical and Pharmaceutical Sciences, University of Hertfordshire, Hatfield, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Peak', 'Affiliation': ""Paediatric Medicines Research Unit, Alder Hey Children's NHS Foundation Trust, Liverpool, UK Matthew.Peak@alderhey.nhs.uk.""}]",BMJ open,['10.1136/bmjopen-2019-036508']
2331,33039992,"Multicentre, randomised, open-label, non-inferiority trial comparing the effectiveness and safety of ductal lavage versus oral corticosteroids for idiopathic granulomatous mastitis: a study protocol.","INTRODUCTION


The ideal treatment for idiopathic granulomatous mastitis (IGM) remains unclear. In a prospective, single-centre, pilot study, we reported that ductal lavage treatment for non-lactational mastitis patients had a 1-year clinical complete response (cCR) rate of >90%, without any significant adverse events. Thus, in this multicentre, randomised, open-label, non-inferiority trial, we will aim to compare the effectiveness and safety of ductal lavage vs oral corticosteroids as the first-line treatment for patients with IGM.
METHODS AND ANALYSIS


The trial will be conducted at the Breast Tumor Center of Sun Yat-sen Memorial Hospital in China and at least at one participating regional centre. We plan to recruit 140 eligible IGM patients who will be randomised into the ductal lavage group or oral corticosteroid group with a 1:1 ratio. The patients in the oral corticosteroid group will receive meprednisone or prednisone for 6 months. The patients in the ductal lavage group will receive ductal lavage and breast massage, as previously reported. All the participants will be followed up at the clinic for 1 year post randomisation. The primary endpoint of this trial will be the 1-year cCR rate, and the secondary endpoints will include the time to cCR, treatment failure rate, relapse rate and protocol compliance rate. The trial was designed to determine whether ductal lavage is non-inferior to oral corticosteroids (1-year cCR rate assumed to be 90%), with a non-inferiority margin of 15%.
ETHICS AND DISSEMINATION


The ethics committee of Sun Yat-sen Memorial Hospital at Sun Yat-sen University approved the study (2018-Lun-Shen-Yan-No. 30). The results of the trial will be communicated to the participating primary care practices, published in international journals and presented at international clinical and scientific conferences.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03724903); Pre-results.",2020,"The trial was designed to determine whether ductal lavage is non-inferior to oral corticosteroids (1-year cCR rate assumed to be 90%), with a non-inferiority margin of 15%.
","['140 eligible IGM patients who will be randomised into the', 'non-lactational mastitis patients', 'patients with IGM', 'Breast Tumor Center of Sun Yat-sen Memorial Hospital in China and at least at one participating regional centre', 'idiopathic granulomatous mastitis']","['meprednisone or prednisone', 'ductal lavage versus oral corticosteroids', 'ductal lavage group or oral corticosteroid', 'ductal lavage and breast massage', 'ductal lavage vs oral corticosteroids']","['time to cCR, treatment failure rate, relapse rate and protocol compliance rate', '1-year clinical complete response (cCR) rate', '1-year cCR rate']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C4552494', 'cui_str': 'Idiopathic granulomatous mastitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024894', 'cui_str': 'Mastitis'}, {'cui': 'C1458155', 'cui_str': 'Neoplasm of breast'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0558281', 'cui_str': 'Regional center'}]","[{'cui': 'C0065967', 'cui_str': 'meprednisone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0525058', 'cui_str': 'Protocol Compliance'}, {'cui': 'C0439234', 'cui_str': 'year'}]",140.0,0.222058,"The trial was designed to determine whether ductal lavage is non-inferior to oral corticosteroids (1-year cCR rate assumed to be 90%), with a non-inferiority margin of 15%.
","[{'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Hu', 'Affiliation': 'Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Shunrong', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': ""Department of Mammary Surgery, Lianjiang People's Hospital, Zhanjiang, Guangdong, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Mammary Surgery, Maternity and Child Health Care Hospital of Jiangmen, Jiangmen, Guangdong, China.'}, {'ForeName': 'Luyuan', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Heran', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jiannan', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Liling', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Fengxi', 'Initials': 'F', 'LastName': 'Su', 'Affiliation': 'Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China chenkai23@mail.sysu.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2019-036643']
2332,33039994,Early Parenting Acceptance and Commitment Therapy 'Early PACT' for parents of infants with cerebral palsy: a study protocol of a randomised controlled trial.,"INTRODUCTION


New international clinical practice guidelines exist for identifying infants at high risk of cerebral palsy (CP) earlier: between 12 to 24 weeks corrected age, significantly earlier than previous diagnosis windows in Australia at 19 months. The earlier detection of infants at high risk of CP creates an opportunity for earlier intervention. The quality of the parent-infant relationship impacts various child outcomes, and is leveraged in other forms of intervention. This paper presents the protocol of a randomised controlled trial of an online parent support programme, Early Parenting Acceptance and Commitment Therapy (Early PACT) for families of infants identified as at high risk of CP. We predict that participating in the Early PACT programme will be associated with improvements in the parent-infant relationship, in parent mental health and well-being as well as infant behaviour and quality of life.
METHODS AND ANALYSIS


This study aims to recruit 60 parents of infants (0 to 2 years old corrected age) diagnosed with CP or identified as at high risk of having CP. Participants will be randomly allocated to one of two groups: Early PACT or waitlist control (1:1). Early PACT is an online parent support programme grounded in Acceptance and Commitment Therapy (ACT). It is delivered as a course on an open source course management system called edX. Early PACT is designed to support parental adjustment and parent-infant relationship around the time of early diagnosis. Assessments will be conducted at baseline, following completion of Early PACT and at 6-month follow-up (retention). The primary outcome will be the quality of parent-child interactions as measured by the Emotional Availability Scale. Standard analysis methods for randomised controlled trial will be used to make comparisons between the two groups (Early PACT and waitlist control). Retention of effects will be examined at 6-month follow-up.
ETHICS AND DISSEMINATION


This study is approved through appropriate Australian and New Zealand ethics committees (see in text) with parents providing written informed consent. Findings from this trial will be disseminated through peer-reviewed journal publications and conference presentations.
TRIAL REGISTRATION DETAILS


This trial has been prospectively registered on 12 June 2018 to present (ongoing) with the Australian New Zealand Clinical Trials Registry (ACTRN12618000986279); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=3 74 896.",2020,"This paper presents the protocol of a randomised controlled trial of an online parent support programme, Early Parenting Acceptance and Commitment Therapy (Early PACT) for families of infants identified as at high risk of CP.","['60 parents of infants (0 to 2 years old corrected age) diagnosed with CP or identified as at high risk of having CP', 'families of infants identified as at high risk of CP', 'parents of infants with cerebral palsy', '12 June 2018 to present (ongoing) with the Australian New Zealand Clinical Trials Registry (ACTRN12618000986279); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=3\u200974\u2009896']","['online parent support programme, Early Parenting Acceptance and Commitment Therapy (Early PACT', ""Early Parenting Acceptance and Commitment Therapy 'Early PACT"", 'Early PACT or waitlist control']",['quality of parent-child interactions as measured by the Emotional Availability Scale'],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.185074,"This paper presents the protocol of a randomised controlled trial of an online parent support programme, Early Parenting Acceptance and Commitment Therapy (Early PACT) for families of infants identified as at high risk of CP.","[{'ForeName': 'Koa', 'Initials': 'K', 'LastName': 'Whittingham', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre (CHRC), Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia koawhittingham@uq.edu.au.'}, {'ForeName': 'Jeanie', 'Initials': 'J', 'LastName': 'Sheffield', 'Affiliation': 'School of Psychology, The University of Queensland, Saint Lucia, Queensland, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mak', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre (CHRC), Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Corrine', 'Initials': 'C', 'LastName': 'Dickinson', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre (CHRC), Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Roslyn N', 'Initials': 'RN', 'LastName': 'Boyd', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre (CHRC), Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-037033']
2333,33040002,"Rationale and design for Lowering-hyperUricaemia treatment on cardiovascular outcoMes In peritoNeal diAlysis patients: a prospective, multicentre, double-blind, randomised controlled trial (LUMINA).","INTRODUCTION


The prevalence of hyperuricaemia in peritoneal dialysis patients is quite high. Studies have demonstrated a correlation between hyperuricaemia and cardiovascular disease and treatment of hyperuricaemia reportedly reduces cardiovascular risk in patients with chronic kidney disease. However, whether hyperuricaemia treatment benefits cardiovascular outcomes in continuous ambulatory peritoneal dialysis (CAPD) patients is not yet known.
METHODS AND ANALYSES


This prospective, multicentre, double-blind, randomised controlled trial was designed to evaluate the effects of hyperuricaemia treatment on cardiovascular event risk in CAPD patients. Based on a power of 80%, with type I error α=0.05, two-sided test and 1:1 parallel control study, considering a dropout rate of 20%, a total of 548 eligible patients are expected to be randomly assigned to either the hyperuricaemia treatment group (febuxostat) or control group (placebo).
ETHICS AND DISSEMINATION


This study has been approved by the Medical Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University and the ethics committees of other participating institutions. Written informed consent will be obtained from potential trial participants or authorised surrogates.The findings of the study will be disseminated through publications in peer-reviewed journals, and presentations at national and international conferences.
TRIAL REGISTRATION NUMBER


NCT03200210. 25 June 2017. The trial was started on 13 July 2017, and is expected to end by 31 December 2022. Till 20 Jan 2020, a total of 548 patients have been recruited.
PROTOCOL VERSION


The protocol version number and date are YLT-1604-V2.0 and 15 December 2016.",2020,Studies have demonstrated a correlation between hyperuricaemia and cardiovascular disease and treatment of hyperuricaemia reportedly reduces cardiovascular risk in patients with chronic kidney disease.,"['548 eligible patients', 'continuous ambulatory peritoneal dialysis (CAPD) patients', 'CAPD patients', 'patients with chronic kidney disease', 'peritoneal dialysis patients', 'peritoNeal diAlysis patients', '13 July 2017, and is expected to end by 31 December 2022', 'Till 20 Jan 2020, a total of 548 patients have been recruited']","['hyperuricaemia treatment', 'hyperuricaemia', 'hyperuricaemia treatment group (febuxostat) or control group (placebo']","['cardiovascular risk', 'cardiovascular event risk', 'cardiovascular outcoMes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031140', 'cui_str': 'Continuous ambulatory peritoneal dialysis'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1273410', 'cui_str': 'Cardiovascular event risk'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",548.0,0.461533,Studies have demonstrated a correlation between hyperuricaemia and cardiovascular disease and treatment of hyperuricaemia reportedly reduces cardiovascular risk in patients with chronic kidney disease.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Sun Yat-sen University First Affiliated Hospital，National Health Commission Key Laboratory of Nephrology (Sun Yat-sen University), Guangdong Provincial Key Laboratory of Nephrology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Naya', 'Initials': 'N', 'LastName': 'Huang', 'Affiliation': 'Department of Nephrology, Sun Yat-sen University First Affiliated Hospital，National Health Commission Key Laboratory of Nephrology (Sun Yat-sen University), Guangdong Provincial Key Laboratory of Nephrology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'Mao', 'Affiliation': 'Department of Nephrology, Sun Yat-sen University First Affiliated Hospital，National Health Commission Key Laboratory of Nephrology (Sun Yat-sen University), Guangdong Provincial Key Laboratory of Nephrology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Nephrology, Sun Yat-sen University First Affiliated Hospital，National Health Commission Key Laboratory of Nephrology (Sun Yat-sen University), Guangdong Provincial Key Laboratory of Nephrology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Medical Statistics, Clinical Trials Unit, Sun Yat-sen University First Affiliated Hospital, Guangzhou, Guangdong, China.'}, {'ForeName': 'Lanping', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Nephrology, Sun Yat-sen University First Affiliated Hospital，National Health Commission Key Laboratory of Nephrology (Sun Yat-sen University), Guangdong Provincial Key Laboratory of Nephrology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'Medical Department, Wanbang Pharmaceutical Marketing and Distribution Co, Shanghai, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'Department of Nephrology, Sun Yat-sen University First Affiliated Hospital，National Health Commission Key Laboratory of Nephrology (Sun Yat-sen University), Guangdong Provincial Key Laboratory of Nephrology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xueqing', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Nephrology, Sun Yat-sen University First Affiliated Hospital，National Health Commission Key Laboratory of Nephrology (Sun Yat-sen University), Guangdong Provincial Key Laboratory of Nephrology, Guangzhou, Guangdong, China yuxq@mail.sysu.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2020-037842']
2334,33040003,Rationale and design of a randomised controlled trial testing the effect of personalised diet in individuals with pre-diabetes or type 2 diabetes mellitus treated with metformin.,"INTRODUCTION


Metformin and diets aimed at promoting healthy body weight are the first line in treating type 2 diabetes mellitus (T2DM). Clinical practice, backed by clinical trials, suggests that many individuals do not reach glycaemic targets using this approach alone. The primary aim of the Personalised Medicine in Pre-diabetes-Towards Preventing Diabetes in Individuals at Risk (PREDICT) Study is to test the efficacy of personalised diet as adjuvant to metformin in improving glycaemic control in individuals with dysglycaemia.
METHODS AND ANALYSIS


PREDICT is a two-arm, parallel group, single-masked randomised controlled trial in adults with pre-diabetes or early-stage T2DM (with glycated haemoglobin (HbA1c) up to 8.0% (64 mmol/mol)), not treated with glucose-lowering medication. PREDICT is conducted at the Clinical Research Facility at the Garvan Institute of Medical Research (Sydney). Enrolment of participants commenced in December 2018 and expected to complete in December 2021. Participants are commenced on metformin (Extended Release, titrated to a target dose of 1500 mg/day) and randomised with equal allocation to either (1) the Personalised Nutrition Project algorithm-based diet or (2) low-fat high-dietary fibre diet, designed to provide caloric restriction (75%) in individuals with body mass index >25 kg/m 2 . Treatment duration is 6 months and participants visit the Clinical Research Facility five times over approximately 7 months. The primary outcome measure is HbA1c. The secondary outcomes are (1) time of interstitial glucose <7.8 mmol/L and (2) glycaemic variability (continuous glucose monitoring), (3) body weight, (4) fat mass and (5) abdominal visceral fat volume (dual-energy X-ray absorptiometry), serum (6) low-density lipoprotein cholesterol (7) high-density lipoprotein cholesterol and (8) triglycerides concentrations, (9) blood pressure, and (10) liver fat (Fibroscan).
ETHICS AND DISSEMINATION


The study has been approved by the St Vincent's Hospital Human Research Ethics Committee (File 17/080, Sydney, Australia) and the Weizmann Institutional Review Board (File 528-3, Rehovot, Israel). The findings will be published in peer-reviewed open access medical journals.
TRIAL REGISTRATION NUMBER


NCT03558867; Pre-results.",2020,The primary aim of the Personalised Medicine in Pre-diabetes-Towards Preventing Diabetes in Individuals at Risk (PREDICT),"['Pre-diabetes-Towards Preventing Diabetes in Individuals at Risk (PREDICT', 'individuals with pre-diabetes or type 2 diabetes mellitus treated with', 'adults with pre-diabetes or early-stage T2DM (with glycated haemoglobin (HbA1c) up to 8.0% (64 mmol/mol)), not treated with glucose-lowering medication', 'individuals with dysglycaemia']","['Personalised Nutrition Project algorithm-based diet or (2) low-fat high-dietary fibre diet, designed to provide caloric restriction', 'personalised diet', 'metformin', 'Personalised Medicine', 'Metformin']","['1) time of interstitial glucose <7.8\u2009mmol/L and (2) glycaemic variability (continuous glucose monitoring), (3) body weight, (4) fat mass and (5) abdominal visceral fat volume (dual-energy X-ray absorptiometry), serum (6) low-density lipoprotein cholesterol (7) high-density lipoprotein cholesterol and (8) triglycerides concentrations, (9) blood pressure, and (10) liver fat (Fibroscan', 'HbA1c']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1522203', 'cui_str': 'Interstitial route'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0549399', 'cui_str': 'Low density lipoprotein increased'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.0948852,The primary aim of the Personalised Medicine in Pre-diabetes-Towards Preventing Diabetes in Individuals at Risk (PREDICT),"[{'ForeName': 'Thaw D', 'Initials': 'TD', 'LastName': 'Htet', 'Affiliation': 'Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Godneva', 'Affiliation': 'Department of Computer Science & Applied Mathematics, Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Zhixin', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Mark Wainwright Analytical Centre, UNSW, Sydney, New South Wales, Australia.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Chalmers', 'Affiliation': 'Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Kolobkov', 'Affiliation': 'Department of Computer Science & Applied Mathematics, Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Snaith', 'Affiliation': 'Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Richens', 'Affiliation': 'Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Krisztina', 'Initials': 'K', 'LastName': 'Toth', 'Affiliation': 'Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Danta', 'Affiliation': ""St Vincent's Clinical School, UNSW, Sydney, New South Wales, Australia.""}, {'ForeName': 'Tien-Ming', 'Initials': 'TM', 'LastName': 'Hng', 'Affiliation': 'Diabetes and Endocrinology, Blacktown Mount Druitt Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Elinav', 'Affiliation': 'Department of Immunology, Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Segal', 'Affiliation': 'Department of Computer Science & Applied Mathematics, Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Jerry R', 'Initials': 'JR', 'LastName': 'Greenfield', 'Affiliation': 'Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dorit', 'Initials': 'D', 'LastName': 'Samocha-Bonet', 'Affiliation': 'Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia d.samochabonet@garvan.org.au.'}]",BMJ open,['10.1136/bmjopen-2020-037859']
2335,33047696,The effects of using phase-contrast microscopy on oral hygiene training of patients receiving orthodontic treatment: A randomized controlled study.,"Objective


To investigate of effects of using phase-contrast video technique on education in oral hygiene training. This one blind, parallel randomized controlled trial was conducted in a tertiary clinic. Fifty-three patients who presented to the orthodontics department aged 12-20 years were divided into two groups randomly by computer-generated assigned codes to receive oral hygiene education. The participants were blinded to type of education method. Before orthodontic therapy, the control group was trained only by the conventional method, while the test group was trained by phase-contrast video microscopy method in addition to conventional method. Some images and videos of moving microorganisms in dental plaque were shown to the patients in test group on a computer monitor.
Subjects and Methods


The bacterial count, plaque index, and gingival index scores were compared. Measurements were obtained in baseline and follow-ups which were repeated with 1-month intervals after the training.
Results


The plaque index scores (1.05 ± 0.1 vs. 1.43 ± 0.2; P < 0.001) and gingival index scores (0.90 ± 0.1 vs. 1.14 ± 0.2; P < 0.001) in test group was statistically lower than those in control group at the end of the study. The gingival index scores reduced by 39% in test group vs. 14% in control group. The number of bacteria significantly decreased in the group trained with phase-contrast video microscope technique (8,059,133 ± 3016 vs. 10,830,600 ± 4919; 0.018).
Conclusions


The training with phase-contrast microscopy has a more positive effect than the traditional method in oral hygiene education.",2020,The gingival index scores reduced by 39% in test group vs. 14% in control group.,"['Fifty-three patients who presented to the orthodontics department aged 12-20 years', 'Subjects and Methods', 'patients receiving orthodontic treatment']","['computer-generated assigned codes to receive oral hygiene education', 'phase-contrast video technique']","['plaque index scores', 'bacterial count, plaque index, and gingival index scores', 'number of bacteria', 'gingival index scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0026024', 'cui_str': 'Phase contrast microscopy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}]",53.0,0.0280386,The gingival index scores reduced by 39% in test group vs. 14% in control group.,"[{'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Koca', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ondokuz Mayıs University, Samsun, Turkey.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Acikgöz', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ondokuz Mayıs University, Samsun, Turkey.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dundar', 'Affiliation': 'Department of Public Health, Faculty of Medicine, Ondokuz Mayıs University, Samsun, Turkey.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kirtiloglu', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ondokuz Mayıs University, Samsun, Turkey.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_365_19']
2336,33047732,[Effect of bioactive glass pretreatment on the durability of dentin bonding interface].,"OBJECTIVE


To study the effect of bioactive glass (BG) on the dentin bond strength and the microleakage of hybrid layer.
METHODS


In the study, 30 dentin planes were prepared from the third molars with no caries and equally assigned to the control group, BG group, and sodium trimetaphosphate (STMP)-polyacrylic acid (PAA)-BG group (S-P-BG group), randomly. After etched with 35% phosphoric acid, the dentin planes of BG group were pretreated with 0.5 g/L BG, and the dentin planes of S-P-BG group were pretreated with 5% STMP, 5% PAA and 0.5 g/L BG. No additional pretreatment was done to the dentin planes of control group. Then the dentin planes were bonded using 3M Single Bond 2 adhesive to 3M Z350XT composite resin, and cut into 0.9 mm×0.9 mm column samples, which were stored at 37 ℃ artificial saliva (AS). After 24 hours, 1 month, and 3 months, the microtensile bond strength test was performed. The data were analyzed using one-way ANOVA and LSD method. The morphology of the bond fracture interface was observed with scanning electron microscope. Other 27 teeth were collected and the enamel layer and roots cut off, with the pulp chamber exposed. 0.1% rhodamine B was added to the 3M Single Bond 2 adhesive, and then the adhesive was applied to complete the bonding procedures as above. The teeth were stored in 37 ℃ AS for 24 hours, 1 month, 3 months, and then 0.1% sodium fluorescein solution was placed in the chambers and stained for 1 hour. Confocal laser scanning microscopy was used to observe the interface morphology and microleakage of the hybrid layer.
RESULTS


At the end of 24 hours and 1 month, there was no significant difference in the microtensile bond strength among the three groups ( P >0.05). After 3 months of soaking, the S-P-BG group [(36.91±7.07) MPa] had significantly higher microtensile bond strength than the control group [(32.73±8.06) MPa] ( P =0.026); For the control group and the BG group, the microtensile bond strength significantly decreased at the end of 3 months compared with 24 hours (control group:  P =0.017, BG group:  P =0.01); The microtensile bond strength of S-P-BG group af the end of 3 months had no significant difference in compared with 24 hours [(37.99±7.98) MPa] ( P >0.05). Observation of the fracture surface at the 24 hours showed no obvious mineralization in all the three groups. After 1 and 3 months, mineral formation was observed in BG group and S-P-BG group, and no obvious collagen exposure was observed in S-P-BG group. Confocal laser scanning microscopy revealed no obvious differences in the morphology and quantity of the resin tag in the control group, BG group and S-P-BG group. At the end of 24 hours, leakage was found in all the three groups. The microleakage of the control group increased at the end of 3 months, while the microleakage of the BG and S-P-BG groups decreased.
CONCLUSION


BG pretreatment of dentin bonding interface can induce mineralization at the bonding interface and reduce the microleakage of the hybrid layer; pretreating the dentin bonding interface with STMP, PAA and BG may enhance the maintaining of the dentin bonding durability.",2020,"At the end of 24 hours and 1 month, there was no significant difference in the microtensile bond strength among the three groups ( P >0.05).","['30 dentin planes were prepared from the third molars with no caries and equally assigned to the control group, BG group, and']","['sodium trimetaphosphate (STMP)-polyacrylic acid (PAA)-BG', 'bioactive glass (BG', 'bioactive glass', 'phosphoric acid', 'sodium fluorescein solution']","['durability of dentin bonding interface', 'obvious collagen exposure', 'morphology of the bond fracture interface', 'microtensile bond strength test', 'microtensile bond strength', 'mineral formation', 'obvious mineralization', 'leakage']","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0054720', 'cui_str': 'Carbomer-940'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0031700', 'cui_str': 'Phosphoric acid'}, {'cui': 'C0147866', 'cui_str': 'Fluorescein sodium stain'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]",,0.019107,"At the end of 24 hours and 1 month, there was no significant difference in the microtensile bond strength among the three groups ( P >0.05).","[{'ForeName': 'Q J', 'Initials': 'QJ', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'W Y', 'Initials': 'WY', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'Y M', 'Initials': 'YM', 'LastName': 'Dong', 'Affiliation': ''}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,[]
2337,33047735,[Effects of loupes and microscope on the prosthodontist's posture from ergonomic aspects].,"OBJECTIVE


To assess the effects of loupes and microscope on the posture of prosthodontists when preparing the laminate veneer, and to assess the clinical value of loupes and microscope from the ergonomic aspects.
METHODS


Twenty young prosthodontists from Department of Prosthodontics, Peking University School and Hospital of Stomatology were recruited into this study, which was a prospective, single blind, self-control trials. The research hypothesis was concealed and the participants were deceived about the precise purpose of the study to counterbalance the lack of direct blinding. The prosthodontists prepared laminate veneers of open window type in the artificial dental model, under routine visual field (control group), 2.5× headwear loupes (loupes group), and 8× operating microscope (microscopic group) by turning. The participants were photographed from profile view and front view. Thereafter, the subjective assessment was performed by themselves using the visual analogue score (VAS). The expert assessment was performed by two professors using modified-dental operator posture assessment instrument on the basis of photographs of the profile view and front view.
RESULTS


The subjective assessment scores for the control group, loupes group and microscopic group were 4.55±1.96, 7.90±1.12, and 9.00±0.92, respectively. There was significant difference between the three groups' subjective scores ( P  < 0.05). The expert assessment scores for the control group, loupes group and microscopic group were 16.38±1.52, 15.15±1.30, and 13.60±0.88, respectively. There was significant difference between the three groups' expert assessment scores ( P  < 0.05). Specifically, the three groups' expert assessment scores were significantly different ( P  < 0.05) in trunk position (front to back) (1.33±0.41, 1.03±0.11, 1.00±0.00), head and neck position (front to back) (2.75±0.38, 2.13±0.36, 1.23±0.38), elbows level (1.38±0.43, 1.40±0.45, 1.13±0.22), and shoulders level (1.43±0.41, 1.23±0.34, 1.13±0.28). Thereinto, the microscopic group was better than loupes group in head and neck position (front to back) and elbows level ( P  < 0.05).
CONCLUSION


Loupes and microscope improve the posture of the prosthodontist when preparing the laminate veneer, in which the microscope is better than loupes. Therefore, the magnification devices have clinical value from the ergonomic aspects.",2020,"The expert assessment scores for the control group, loupes group and microscopic group were 16.38±1.52, 15.15±1.30, and 13.60±0.88, respectively.","['Twenty young prosthodontists from Department of Prosthodontics, Peking University School and Hospital of Stomatology']","['routine visual field (control group), 2.5× headwear loupes (loupes group), and 8× operating microscope (microscopic group) by turning', 'loupes and microscope']","['head and neck position', 'elbows level', 'subjective assessment scores', 'subjective scores', 'shoulders level', 'visual analogue score (VAS']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1555936', 'cui_str': 'Prosthodontist'}, {'cui': 'C0033590', 'cui_str': 'Prosthodontics'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029167', 'cui_str': 'Medicine, Oral'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453967', 'cui_str': 'Headwear'}, {'cui': 'C0549181', 'cui_str': 'Loupes'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0181839', 'cui_str': 'Microscope'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}]","[{'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",20.0,0.0149003,"The expert assessment scores for the control group, loupes group and microscopic group were 16.38±1.52, 15.15±1.30, and 13.60±0.88, respectively.","[{'ForeName': 'X Q', 'Initials': 'XQ', 'LastName': 'Liu', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of General Dentistry Ⅱ, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Zhou', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Tan', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,[]
2338,33047942,An optimal chest compression technique using personal protective equipment during resuscitation in the COVID-19 pandemic: a randomized crossover simulation study.,"BACKGROUND


Cardiopulmonary resuscitation (CPR) with the use of personal protective equipment (PPE) for aerosol generating procedures (AGP) in patients with suspected/confirmed COVID-19 remains challenging.
AIM


The aim of this study was to compare three chest compression methods applied by paramedics wearing PPE.
METHODS


The single-blinded, multi-centre, randomized, cross-over simulation study involved 67 paramedics wearing PPE AGP. They performed 2-minute continuous chest compressions (CCs) in an adult patient with suspected/confirmed COVID-19 in three scenarios: (a) manual CCs; (b) CCs with a TrueCPR feedback device; (c) CCs with a LUCAS3 mechanical CC device.
RESULTS


CC depth when using LUCAS3 compared with TrueCPR and manual CC was more frequently correct 51 [50-55] vs. 47 [43-52] vs. 43 [38-46]mm; P = 0.005) and more often performed correctly regarding CC rate 102 [100-102] vs. 105 [98-1114] vs. 116 [112-129] compressions per minute; P = 0.027) and chest recoil 100 [98-100] vs. 83 [60-92] vs. 39  [25-50]%; P = 0.001). A detailed analysis of 2-minute resuscitation with manual CCs showed a decrease in compression depth and full chest recoil after 1 minute of CCs.
CONCLUSION


We show that during simulated resuscitation with the use of PPE AGP in patients with suspected/confirmed COVID-19, CC with LUCAS3 compared with manual CCs as well as a TrueCPR feedback device essentially increased CC quality. In the case of manual CCs by paramedics dressed in PPE AGP, it is advisable to change the person performing CC every minute.",2020,"A detailed analysis of 2-minute resuscitation with manual CCs showed a decrease in compression depth and full chest recoil after 1 minute of CCs.
","['67 paramedics wearing PPE AGP', 'patients with suspected/confirmed COVID-19 remains challenging']","['PPE AGP', 'personal protective equipment', 'personal protective equipment (PPE', 'manual CCs; (b) CCs with a TrueCPR feedback device; (c) CCs with a LUCAS3 mechanical CC device', 'Cardiopulmonary resuscitation (CPR', '2-minute continuous chest compressions (CCs']","['CC quality', 'compression depth and full chest recoil']","[{'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}]",67.0,0.0765402,"A detailed analysis of 2-minute resuscitation with manual CCs showed a decrease in compression depth and full chest recoil after 1 minute of CCs.
","[{'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Małysz', 'Affiliation': ''}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Smereka', 'Affiliation': ''}, {'ForeName': 'Miłosz', 'Initials': 'M', 'LastName': 'Jaguszewski', 'Affiliation': ''}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Dąbrowski', 'Affiliation': ''}, {'ForeName': 'Klaudiusz', 'Initials': 'K', 'LastName': 'Nadolny', 'Affiliation': ''}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Ruetzler', 'Affiliation': ''}, {'ForeName': 'Jerzy R', 'Initials': 'JR', 'LastName': 'Ładny', 'Affiliation': ''}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Sterliński', 'Affiliation': ''}, {'ForeName': 'Krzysztof J', 'Initials': 'KJ', 'LastName': 'Filipiak', 'Affiliation': ''}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Szarpak', 'Affiliation': ''}]",Kardiologia polska,['10.33963/KP.15643']
2339,33047944,Efficacy of a proprioceptive exercise program in patients with nonspecific neck pain. A randomized controlled trial.,"BACKGROUND


Nonspecific neck pain is associated with chronic pain, disability, reduced cervical mobility, postural control disorders and impaired proprioceptive control.
AIM


To compare the effectiveness of two therapeutic exercise programs (i.e. cervical proprioception and cervical mobility) in reducing pain and disability in individuals with nonspecific neck pain. We further aimed to compare the effectiveness of the two treatments in improving pressure pain threshold, cervical range of motion and head repositioning accuracy.
DESIGN


Randomized controlled trial.
SETTING


Private rehabilitation clinic.
POPULATION


Forty-two participants diagnosed with nonspecific neck pain, aged 18-65 years, were randomized to a Cervical Mobility Group (n=22) or a Proprioception Group (n=20).
METHODS


The Cervical Mobility Group combined a passive treatment and active mobility exercises, whereas the Proprioception Group combined a passive treatment and proprioceptive exercises. Pain intensity, disability, pressure pain threshold, range of motion, and head repositioning accuracy were assessed at baseline and after 10 sessions.
RESULTS


Pain intensity and disability significantly improved for both interventions (p<0.01), but such improvement was greater for pain intensity in the Proprioception Group than in the Cervical Mobility Group (p<0.01). Pressure pain threshold, range of motion and head repositioning accuracy improved only in the Proprioception Group (p<0.01).
CONCLUSIONS


A program based on cervical proprioception exercises improves pain, disability, pressure pain threshold, range of motion and head repositioning accuracy in patients with nonspecific neck pain. However, a program based on cervical mobility exercises only improves pain intensity and disability, while such improvement is not clinically relevant.
CLINICAL REHABILITATION IMPACT


The proprioceptive exercise program may be considered as the treatment of choice in patients with nonspecific neck pain.",2020,"Pressure pain threshold, range of motion and head repositioning accuracy improved only in the Proprioception Group (p<0.01).
","['Private rehabilitation clinic', 'patients with nonspecific neck pain', 'individuals with nonspecific neck pain', 'Forty-two participants diagnosed with nonspecific neck pain, aged 18-65 years']","['Proprioception Group', 'therapeutic exercise programs (i.e. cervical proprioception and cervical mobility', 'Cervical Mobility Group', 'cervical proprioception exercises', 'proprioceptive exercise program', 'passive treatment and active mobility exercises, whereas the Proprioception Group combined a passive treatment and proprioceptive exercises']","['pain, disability, pressure pain threshold, range of motion and head repositioning accuracy', 'pain intensity', 'Pain intensity and disability', 'pain and disability', 'Pain intensity, disability, pressure pain threshold, range of motion, and head repositioning accuracy', 'pressure pain threshold, cervical range of motion and head repositioning accuracy', 'pain intensity and disability', 'Pressure pain threshold, range of motion and head repositioning accuracy']","[{'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0454280', 'cui_str': 'Proprioceptive exercises'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]",42.0,0.10697,"Pressure pain threshold, range of motion and head repositioning accuracy improved only in the Proprioception Group (p<0.01).
","[{'ForeName': 'Gemma V', 'Initials': 'GV', 'LastName': 'Espí-López', 'Affiliation': 'Department of Physical Therapy, Faculty of Physical Therapy, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Aguilar-Rodríguez', 'Affiliation': 'Department of Physical Therapy, Faculty of Physical Therapy, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Zarzoso', 'Affiliation': 'Department of Physical Therapy, Faculty of Physical Therapy, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Serra-AÑÓ', 'Affiliation': 'Department of Physical Therapy, Faculty of Physical Therapy, University of Valencia, Valencia, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Martínez de la Fuente', 'Affiliation': 'Department of Physical Therapy, Faculty of Physical Therapy, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Inglés', 'Affiliation': 'Department of Physical Therapy, Faculty of Physical Therapy, University of Valencia, Valencia, Spain - marta.ingles@uv.es.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Marques-Sule', 'Affiliation': 'Department of Physical Therapy, Faculty of Physical Therapy, University of Valencia, Valencia, Spain.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.20.06302-9']
2340,33047971,"Intraoperative 99mTc-MIBI-Guided Parathyroidectomy Improves Curative Effect of Parathyroidectomy, Bone Metabolism, and Bone Mineral Density.","This study aimed to compare the postoperative effects of total parathyroidectomy plus forearm transplantation and radioguided parathyroidectomy on bone metabolism and bone mineral density (BMD). From June 2013 to October 2017, 67 patients with renal secondary hyperparathyroidism (SHPT) received surgical treatment. The control group included 30 cases of classical total parathyroidectomy plus forearm transplantation for SHPT. In the experimental group, 37 patients underwent 99mTc-MIBI-guided parathyroidectomy. Demographics, parathyroid hormone (PTH) level, blood calcium level, and pathological results were compared between the 2 groups. The curative effect of parathyroidectomy and its effect on BMD were also compared. The BMDs in the L1-L4 segments and femoral neck in both groups were significantly improved after operation (all  P  < .05). The  T  scores of the L1-L4 segments and femoral neck in both groups were significantly improved after operation (all  P  < .05). The improvement in the  T  score of the L4 in the experimental group was significantly higher than that in the control group ( P  < .05). No significant differences in the improvement in the L1-L3 segments and femoral neck were found between the 2 groups. Both traditional total parathyroidectomy plus forearm transplantation and 99mTc-MIBI-guided parathyroidectomy can improve PTH level, blood calcium level, phosphorus level, bone metabolism, and BMD to varying degrees in patients with SHPT. Compared with the traditional surgery, 99mTc-MIBI-guided parathyroidectomy can improve blood calcium and phosphorus metabolisms, reduce PTH level, and improve the  T  scores of L4 to a greater extent.",2020,No significant differences in the improvement in the L1-L3 segments and femoral neck were found between the 2 groups.,"['37 patients underwent', 'From June 2013 to October 2017, 67 patients with renal secondary hyperparathyroidism (SHPT) received surgical treatment', 'patients with SHPT']","['traditional total parathyroidectomy plus forearm transplantation and 99mTc-MIBI-guided parathyroidectomy', 'parathyroidectomy', 'total parathyroidectomy plus forearm transplantation and radioguided parathyroidectomy', 'Intraoperative 99mTc-MIBI-Guided Parathyroidectomy', '99mTc-MIBI-guided parathyroidectomy', 'classical total parathyroidectomy plus forearm transplantation for SHPT']","['T  score of the L4', 'bone metabolism and bone mineral density (BMD', 'T  scores of the L1-L4 segments and femoral neck', 'Demographics, parathyroid hormone (PTH) level, blood calcium level, and pathological results', 'L1-L3 segments and femoral neck', 'PTH level, blood calcium level, phosphorus level, bone metabolism, and BMD', 'blood calcium and phosphorus metabolisms, reduce PTH level', 'Parathyroidectomy, Bone Metabolism, and Bone Mineral Density', 'BMD', 'BMDs in the L1-L4 segments and femoral neck']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271847', 'cui_str': 'Hyperparathyroidism due to renal insufficiency'}, {'cui': 'C0020503', 'cui_str': 'Secondary hyperparathyroidism'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0193696', 'cui_str': 'Complete parathyroidectomy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1692878', 'cui_str': '99mTc(HYNICtide)(tricine)(TPPTS)'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0020503', 'cui_str': 'Secondary hyperparathyroidism'}]","[{'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0729820', 'cui_str': 'Blood calcium measurement'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}]",67.0,0.0195953,No significant differences in the improvement in the L1-L3 segments and femoral neck were found between the 2 groups.,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': '56694 Department of Head and Neck Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': '56694 Department of Head and Neck Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Qinyi', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': '56694 Department of Head and Neck Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': '56694 Department of Head and Neck Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Xiangchao', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': '56694 Department of Bone and Joint Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': '56694 Department of Bone and Joint Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jiadong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': '56694 Department of Head and Neck Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}]",The American surgeon,['10.1177/0003134820951467']
2341,33047991,A comparative evaluation of diffractive trifocal and new refractive/extended depth of focus intraocular lenses for refractive lens exchange.,"PURPOSE


To evaluate and compare the visual performance and quality of life (QOL) associated with refractive/extended depth of focus (EDOF) intraocular lenses (IOLs) and diffractive trifocal IOLs in refractive lens exchange patients.
MATERIALS AND METHODS


This was a comparative interventional study of patients undergoing implantation of Lucidis (Swiss Advanced Vision, SAV‑IOL SA, Neuchâtel, Switzerland) or AT LISA tri 839MP (Carl Zeiss Meditec AG, Germany) IOLs. Near, intermediate, and distance best corrected and uncorrected visual acuities were collected at one and three months postoperatively. The vision-related QOL was evaluated one and three months after surgery, using the National Eye Institute Visual Function Questionnaire-14 (VF-14 QOL questionnaire).
RESULTS


A total of 74 patients underwent refractive lens exchange and IOL implantation, with 38 patients in the EDOF group and 36 in the trifocal group. Among all visual acuities, uncorrected near visual acuity was statistically significantly better with the Lucidis IOL at the first month (p = 0.02) and diminished at the third month visit (p = 0.16). When we compared the VF-14 QOL questionnaire scores, reading small print, reading a newspaper or book, and driving at night were statistically significantly better in the Lucidis group at the first month (p = 0.00, for each). That difference persisted only in driving at night at the third month visit (p = 0.04). Reading small print, driving at night, and doing fine handwork were the most difficult tasks in the AT LISA group at the first month, and only driving at night remained so at the third month visit.
CONCLUSIONS


The refractive results and visual outcomes at all distances of EDOF and trifocal IOLs were highly satisfactory. However, the EDOF design in the Lucidis IOL achieves lower rates of glare in the early period after refractive lens exchange.",2020,"Among all visual acuities, uncorrected near visual acuity was statistically significantly better with the Lucidis IOL at the first month (p = 0.02) and diminished at the third month visit (p = 0.16).","['74 patients underwent refractive lens exchange and IOL implantation, with 38 patients in the EDOF group and 36 in the trifocal group', 'refractive lens exchange patients', 'patients undergoing implantation of Lucidis (Swiss Advanced Vision, SAV‑IOL SA, Neuchâtel, Switzerland) or AT LISA tri 839MP (Carl Zeiss Meditec AG, Germany) IOLs']","['diffractive trifocal and new refractive/extended depth of focus intraocular lenses', 'refractive/extended depth of focus (EDOF) intraocular lenses (IOLs']","['Near, intermediate, and distance best corrected and uncorrected visual acuities', 'vision-related QOL', 'VF-14 QOL questionnaire scores, reading small print, reading a newspaper or book, and driving at night', 'visual performance and quality of life (QOL', 'Reading small print, driving at night, and doing fine handwork', 'visual acuities, uncorrected near visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532365', 'cui_str': 'Refractive lensectomy with intraocular lens implantation'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]","[{'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]","[{'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}]",74.0,0.0300612,"Among all visual acuities, uncorrected near visual acuity was statistically significantly better with the Lucidis IOL at the first month (p = 0.02) and diminished at the third month visit (p = 0.16).","[{'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Ozulken', 'Affiliation': 'Ophthalmology Department, TOBB ETU Medical School , Ankara, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Kiziltoprak', 'Affiliation': ""Ophthalmology Department, Bingol Women's Health and Children's Hospital , Bingol, Turkey.""}, {'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Yuksel', 'Affiliation': 'Ophthalmology Department, Kastamonu Medical School , Kastamonu, Turkey.'}, {'ForeName': 'Tarkan', 'Initials': 'T', 'LastName': 'Mumcuoğlu', 'Affiliation': 'Ophthalmology Department, TOBB ETU Medical School , Ankara, Turkey.'}]",Current eye research,['10.1080/02713683.2020.1833347']
2342,33048154,Effect of Sustained Smoking Cessation Counseling and Provision of Medication vs Shorter-term Counseling and Medication Advice on Smoking Abstinence in Patients Recently Diagnosed With Cancer: A Randomized Clinical Trial.,"Importance


Persistent smoking may cause adverse outcomes among patients with cancer. Many cancer centers have not fully implemented evidence-based tobacco treatment into routine care.
Objective


To determine the effectiveness of sustained telephone counseling and medication (intensive treatment) compared with shorter-term telephone counseling and medication advice (standard treatment) to assist patients recently diagnosed with cancer to quit smoking.
Design, Setting, and Participants


This unblinded randomized clinical trial was conducted at Massachusetts General Hospital/Dana-Farber/Harvard Cancer Center and Memorial Sloan Kettering Cancer Center. Adults who had smoked 1 cigarette or more within 30 days, spoke English or Spanish, and had recently diagnosed breast, gastrointestinal, genitourinary, gynecological, head and neck, lung, lymphoma, or melanoma cancers were eligible. Enrollment occurred between November 2013 and July 2017; assessments were completed by the end of February 2018.
Interventions


Participants randomized to the intensive treatment (n = 153) and the standard treatment (n = 150) received 4 weekly telephone counseling sessions and medication advice. The intensive treatment group also received 4 biweekly and 3 monthly telephone counseling sessions and choice of Food and Drug Administration-approved cessation medication (nicotine replacement therapy, bupropion, or varenicline).
Main Outcome and Measures


The primary outcome was biochemically confirmed 7-day point prevalence tobacco abstinence at 6-month follow-up. Secondary outcomes were treatment utilization rates.
Results


Among 303 patients who were randomized (mean age, 58.3 years; 170 women [56.1%]), 221 (78.1%) completed the trial. Six-month biochemically confirmed quit rates were 34.5% (n = 51 in the intensive treatment group) vs 21.5% (n = 29 in the standard treatment group) (difference, 13.0% [95% CI, 3.0%-23.3%]; odds ratio, 1.92 [95% CI, 1.13-3.27]; P < .02). The median number of counseling sessions completed was 8 (interquartile range, 4-11) in the intensive treatment group. A total of 97 intensive treatment participants (77.0%) vs 68 standard treatment participants (59.1%) reported cessation medication use (difference, 17.9% [95% CI, 6.3%-29.5%]; odds ratio, 2.31 [95% CI, 1.32-4.04]; P = .003). The most common adverse events in the intensive treatment and standard treatment groups, respectively, were nausea (n = 13 and n = 6), rash (n = 4 and n = 1), hiccups (n = 4 and n = 1), mouth irritation (n = 4 and n = 0), difficulty sleeping (n = 3 and n = 2), and vivid dreams (n = 3 and n = 2).
Conclusions and Relevance


Among smokers recently diagnosed with cancer in 2 National Cancer Institute-designated Comprehensive Cancer Centers, sustained counseling and provision of free cessation medication compared with 4-week counseling and medication advice resulted in higher 6-month biochemically confirmed quit rates. However, the generalizability of the study findings is uncertain and requires further research.
Trial Registration


ClinicalTrials.gov Identifier: NCT01871506.",2020,"Six-month biochemically confirmed quit rates were 34.5% (n = 51 in the intensive treatment group) vs 21.5% (n = 29 in the standard treatment group) (difference, 13.0% [95% CI, 3.0%-23.3%]; odds ratio, 1.92 [95% CI, 1.13-3.27]; P < .02).","['Adults who had smoked 1 cigarette or more within 30 days, spoke English or Spanish, and had recently diagnosed breast, gastrointestinal, genitourinary, gynecological, head and neck, lung, lymphoma, or melanoma cancers were eligible', 'Massachusetts General Hospital/Dana-Farber/Harvard Cancer Center and Memorial Sloan Kettering Cancer Center', 'Patients Recently Diagnosed With Cancer', 'patients recently diagnosed with cancer to quit smoking', '303 patients who were randomized (mean age, 58.3 years; 170 women [56.1%]), 221 (78.1%) completed the trial', 'patients with cancer']","['Sustained Smoking Cessation Counseling and Provision of Medication vs Shorter-term Counseling and Medication Advice', 'sustained telephone counseling and medication (intensive treatment', 'intensive treatment (n\u2009=\u2009153) and the standard treatment (n\u2009=\u2009150) received 4 weekly telephone counseling sessions and medication advice', 'shorter-term telephone counseling and medication advice (standard treatment', 'telephone counseling sessions and choice of Food and Drug Administration-approved cessation medication (nicotine replacement therapy, bupropion, or varenicline']","['quit rates', 'treatment utilization rates', 'Smoking Abstinence', 'median number of counseling sessions', 'mouth irritation', 'nausea', 'cessation medication use', '7-day point prevalence tobacco abstinence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0024874', 'cui_str': 'Massachusetts'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0268255', 'cui_str': ""Farber's lipogranulomatosis""}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0235339', 'cui_str': 'Mouth irritation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}]",2.0,0.152051,"Six-month biochemically confirmed quit rates were 34.5% (n = 51 in the intensive treatment group) vs 21.5% (n = 29 in the standard treatment group) (difference, 13.0% [95% CI, 3.0%-23.3%]; odds ratio, 1.92 [95% CI, 1.13-3.27]; P < .02).","[{'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Health Policy Research Center, Mongan Institute, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Giselle K', 'Initials': 'GK', 'LastName': 'Perez', 'Affiliation': 'Health Policy Research Center, Mongan Institute, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Alona', 'Initials': 'A', 'LastName': 'Muzikansky', 'Affiliation': 'MGH Biostatistics Center, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Levy', 'Affiliation': 'Health Policy Research Center, Mongan Institute, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Health Policy Research Center, Mongan Institute, Massachusetts General Hospital, Boston.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Pirl', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Irwin', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Partridge', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Cooley', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Friedman', 'Affiliation': 'Health Policy Research Center, Mongan Institute, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Rabin', 'Affiliation': 'Health Policy Research Center, Mongan Institute, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Ponzani', 'Affiliation': 'Health Policy Research Center, Mongan Institute, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Hyland', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Holland', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Borderud', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Sprunck', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Kwon', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Miller-Sobel', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Gonzalez', 'Affiliation': 'Health Policy Research Center, Mongan Institute, Massachusetts General Hospital, Boston.'}, {'ForeName': 'C Will', 'Initials': 'CW', 'LastName': 'Whitlock', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Malloy', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Suhana', 'Initials': 'S', 'LastName': 'de León-Sanchez', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Jamie S', 'Initials': 'JS', 'LastName': 'Ostroff', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}]",JAMA,['10.1001/jama.2020.14581']
2343,33048179,Pilot study: pudendal neuromodulation combined with pudendal nerve release in case of chronic perineal pain syndrome. The ENTRAMI technique: early results.,"INTRODUCTION AND HYPOTHESIS


Chronic perineal pain syndrome due to pudendal nerve impingement is difficult to diagnose and to treat. All the known treatment options leave room for improvement considering the outcome. Early neuromodulation of the pudendal nerve after its surgical release could improve outcomes.
OBJECTIVES


The aim of the study was to evaluate the potential beneficial effect of pudendal neuromodulation combined with release surgery using the ENTRAMI technique (endoscopic transgluteal minimally invasive technique).
STUDY DESIGN


This is a single-center prospective descriptive study. Between March 2019 and March 2020, 16 patients (2 males, 14 females) were included. Data were collected at baseline and 1 month after surgery.
METHODS


Patients eligible for inclusion had chronic perineal pain for at least 3 months in the area served by the pudendal nerve. We combined pudendal nerve release with neuromodulation.
RESULTS


At 1 month, the numeric pain rating scale (NPRS) dropped from 9.5 at baseline to 3.5 (p = 0.003). Seventy-six percent of patients showed a global impression of change (PGIC) of > 50% at 1 month, and optimal treatment response (PGIC ≥ 90%) was found in 41% of patients.
LIMITATIONS


The drawback of our study was that it was not randomized or blinded. The peripheral nerve evaluation lead (PNE) used could only be implanted for 1 month because of infection risk and is also prone to dislocations and technical failures.
CONCLUSION


Pudendal nerve liberation by the ENTRAMI technique combined with short-term pudendal neuromodulation seems feasible and promising in treating patients with chronic perineal pain. Clinical trial number: NCT03880786.",2020,"Seventy-six percent of patients showed a global impression of change (PGIC) of > 50% at 1 month, and optimal treatment response (PGIC ≥ 90%) was found in 41% of patients.
","['chronic perineal pain syndrome', 'Between March 2019 and March 2020, 16 patients (2 males, 14 females) were included', 'Chronic perineal pain syndrome', 'Patients eligible for inclusion had chronic perineal pain for at least 3\xa0months in the area served by the pudendal nerve', 'patients with chronic perineal pain']","['pudendal neuromodulation combined with release surgery using the ENTRAMI technique (endoscopic transgluteal minimally invasive technique', 'pudendal neuromodulation combined with pudendal nerve release']","['global impression of change (PGIC', 'numeric pain rating scale (NPRS']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235641', 'cui_str': 'Pain in female perineum'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0228959', 'cui_str': 'Structure of pudendal nerve'}]","[{'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0444462', 'cui_str': 'Transgluteal approach'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0228959', 'cui_str': 'Structure of pudendal nerve'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0348058,"Seventy-six percent of patients showed a global impression of change (PGIC) of > 50% at 1 month, and optimal treatment response (PGIC ≥ 90%) was found in 41% of patients.
","[{'ForeName': 'Katleen', 'Initials': 'K', 'LastName': 'Jottard', 'Affiliation': 'Department of Surgery, CHU Brugmann, Arthur Van Gehuchtenplaats 4, 1020, Brussels, Belgium. Katleen.jottard@chu-brugmann.be.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Bruyninx', 'Affiliation': 'Department of Surgery, CHU Brugmann, Arthur Van Gehuchtenplaats 4, 1020, Brussels, Belgium.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bonnet', 'Affiliation': 'Department of Urology and Department of Anatomy, CHU Sart-Tilman, Liège, Belgium.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Mathieu', 'Affiliation': 'Department of Anesthesiology, Pain Clinic, Brugmann Hospital, Brussels, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'De Wachter', 'Affiliation': 'Department of Urology, Antwerp University Hospital, Edegem, Belgium.'}]",International urogynecology journal,['10.1007/s00192-020-04565-1']
2344,33048195,"Viscoelastic haemostatic assay augmented protocols for major trauma haemorrhage (ITACTIC): a randomized, controlled trial.","PURPOSE


Contemporary trauma resuscitation prioritizes control of bleeding and uses major haemorrhage protocols (MHPs) to prevent and treat coagulopathy. We aimed to determine whether augmenting MHPs with Viscoelastic Haemostatic Assays (VHA) would improve outcomes compared to Conventional Coagulation Tests (CCTs).
METHODS


This was a multi-centre, randomized controlled trial comparing outcomes in trauma patients who received empiric MHPs, augmented by either VHA or CCT-guided interventions. Primary outcome was the proportion of subjects who, at 24 h after injury, were alive and free of massive transfusion (10 or more red cell transfusions). Secondary outcomes included 28-day mortality. Pre-specified subgroups included patients with severe traumatic brain injury (TBI).
RESULTS


Of 396 patients in the intention to treat analysis, 201 were allocated to VHA and 195 to CCT-guided therapy. At 24 h, there was no difference in the proportion of patients who were alive and free of massive transfusion (VHA: 67%, CCT: 64%, OR 1.15, 95% CI 0.76-1.73). 28-day mortality was not different overall (VHA: 25%, CCT: 28%, OR 0.84, 95% CI 0.54-1.31), nor were there differences in other secondary outcomes or serious adverse events. In pre-specified subgroups, there were no differences in primary outcomes. In the pre-specified subgroup of 74 patients with TBI, 64% were alive and free of massive transfusion at 24 h compared to 46% in the CCT arm (OR 2.12, 95% CI 0.84-5.34).
CONCLUSION


There was no difference in overall outcomes between VHA- and CCT-augmented-major haemorrhage protocols.",2020,"28-day mortality was not different overall (VHA: 25%, CCT: 28%, OR 0.84, 95% CI 0.54-1.31), nor were there differences in other secondary outcomes or serious adverse events.","['patients with severe traumatic brain injury (TBI', 'trauma patients who received empiric MHPs, augmented by either VHA or CCT-guided interventions', '396 patients in the intention to treat analysis', 'major trauma haemorrhage (ITACTIC']","['Viscoelastic haemostatic assay augmented protocols', 'MHPs with Viscoelastic Haemostatic Assays (VHA', 'CCT-guided therapy']","['proportion of subjects who, at 24\xa0h after injury, were alive and free of massive transfusion', '28-day mortality', 'alive and free of massive transfusion', 'overall outcomes between VHA- and CCT-augmented-major haemorrhage protocols', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C5191354', 'cui_str': '396'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0332677', 'cui_str': 'Major injury'}]","[{'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",74.0,0.186377,"28-day mortality was not different overall (VHA: 25%, CCT: 28%, OR 0.84, 95% CI 0.54-1.31), nor were there differences in other secondary outcomes or serious adverse events.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Baksaas-Aasen', 'Affiliation': 'Oslo University Hospital & University of Oslo, Oslo, Norway.'}, {'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Gall', 'Affiliation': 'Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute, 4 Newark Street, London, E1 2AT, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stensballe', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'N P', 'Initials': 'NP', 'LastName': 'Juffermans', 'Affiliation': 'Amsterdam University Medical Centres, Amsterdam, The Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Curry', 'Affiliation': 'Oxford University Hospital NHS Trust, Oxford, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maegele', 'Affiliation': 'Cologne-Merheim Medical Centre, University of Witten/Herdecke, Cologne, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brooks', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rourke', 'Affiliation': 'Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute, 4 Newark Street, London, E1 2AT, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gillespie', 'Affiliation': 'Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute, 4 Newark Street, London, E1 2AT, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Maroni', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vulliamy', 'Affiliation': 'Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute, 4 Newark Street, London, E1 2AT, UK.'}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Henriksen', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'K Holst', 'Initials': 'KH', 'LastName': 'Pedersen', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Kolstadbraaten', 'Affiliation': 'Oslo University Hospital & University of Oslo, Oslo, Norway.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Wirtz', 'Affiliation': 'Amsterdam University Medical Centres, Amsterdam, The Netherlands.'}, {'ForeName': 'D J B', 'Initials': 'DJB', 'LastName': 'Kleinveld', 'Affiliation': 'Amsterdam University Medical Centres, Amsterdam, The Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Schäfer', 'Affiliation': 'Cologne-Merheim Medical Centre, University of Witten/Herdecke, Cologne, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chinna', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Davenport', 'Affiliation': 'Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute, 4 Newark Street, London, E1 2AT, UK.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Naess', 'Affiliation': 'Oslo University Hospital & University of Oslo, Oslo, Norway.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Goslings', 'Affiliation': 'Amsterdam University Medical Centres, Amsterdam, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Eaglestone', 'Affiliation': 'Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute, 4 Newark Street, London, E1 2AT, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Stanworth', 'Affiliation': 'Oxford University Hospital NHS Trust, Oxford, UK.'}, {'ForeName': 'P I', 'Initials': 'PI', 'LastName': 'Johansson', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gaarder', 'Affiliation': 'Oslo University Hospital & University of Oslo, Oslo, Norway.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Brohi', 'Affiliation': 'Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute, 4 Newark Street, London, E1 2AT, UK. k.brohi@qmul.ac.uk.'}]",Intensive care medicine,['10.1007/s00134-020-06266-1']
2345,33048319,Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial.,"INTRODUCTION


Patient reporting adds value to pharmacovigilance. Encouraging it to be done through a mobile device application (App) is a method that should be evaluated.
OBJECTIVE


This study aimed to determine whether the use of an App, compared to traditional use through e-mail, telephone, or the national website, increased suspected adverse drug reaction (ADR) reporting by persons with multiple sclerosis receiving a first-line disease-modifying drug.
METHODS


An open multi-centric, cluster-randomized controlled trial was conducted (VigipSEP study). Clusters were centers allocated (1:1) to the use of the My eReport France ®  App (experimental arm), and traditional reporting (control arm). Persons with multiple sclerosis initiating or switching to a first-line disease-modifying drug between April 2017 and April 2019 were included. The primary outcome was the mean number of ADR reports per patient for the center-level analysis, and the number of ADR reports per patient for the individual-level analysis using the hierarchical Poisson regression model.
RESULTS


Twenty-four centers (12 per arm: six public neurologists from the multiple sclerosis academic expert centers, three public neurologists from general hospitals, and three private practice neurologists) were randomized, including 159 patients. The mean number of ADR reports per patient was significantly higher in centers that used the App: 0.47 vs 0.03 in control centers (p = 0.002). At an individual-level analysis, the experimental arm was significantly associated with a relative risk of ADR reports at 18.6 (95% confidence interval 4.1-84.2; p < 0.001), compared to the control arm, adjusted for sex and type of disease-modifying drug.
CONCLUSIONS


The use of a mobile App increased the ADR reporting by persons with multiple sclerosis receiving a first-line disease-modifying drug. CLINICALTRIALS.
GOV IDENTIFIER


NCT03029897, registered in 2017.",2020,The mean number of ADR reports per patient was significantly higher in centers that used the App: 0.47 vs 0.03 in control centers (p = 0.002).,"['persons with multiple sclerosis receiving a first-line disease-modifying drug', 'Persons with Multiple Sclerosis', 'Persons with multiple sclerosis initiating or switching to a first-line disease-modifying drug between April 2017 and April 2019 were included', 'Twenty-four centers (12 per arm: six public neurologists from the multiple sclerosis academic expert centers, three public neurologists from general hospitals, and three private practice neurologists) were randomized, including 159 patients']",['Adverse Drug Reaction Reporting Using a Mobile Device Application'],"['mean number of ADR reports per patient for the center-level analysis', 'ADR reporting', 'mean number of ADR reports per patient']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0237426', 'cui_str': 'Neurologist'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",,0.145401,The mean number of ADR reports per patient was significantly higher in centers that used the App: 0.47 vs 0.03 in control centers (p = 0.002).,"[{'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Defer', 'Affiliation': 'Neurology Department, Caen University Hospital, Caen, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Fedrizzi', 'Affiliation': 'Pharmacology Department, Caen University Hospital, Caen, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Chevanne', 'Affiliation': 'Neurology Department, Caen University Hospital, Caen, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Montastruc', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Centre of Pharmacovigilance and Pharmacoepidemiology, Toulouse University Hospital, Faculty of Medicine, University of Toulouse, Toulouse, France.'}, {'ForeName': 'Anais R', 'Initials': 'AR', 'LastName': 'Briant', 'Affiliation': 'Clinical Research Department, Caen University Hospital, 14033, Caen Cedex 9, France.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Parienti', 'Affiliation': 'Clinical Research Department, Caen University Hospital, 14033, Caen Cedex 9, France.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Peyro-Saint-Paul', 'Affiliation': 'Clinical Research Department, Caen University Hospital, 14033, Caen Cedex 9, France. peyrosaintpaul-l@chu-caen.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Drug safety,['10.1007/s40264-020-01009-z']
2346,32996170,Machine Learning to Predict Transplant Outcomes: Helpful or Hype?,"An increasing number of studies claim machine learning (ML) predicts transplant outcomes more accurately. However, these claims were possibly confounded by other factors, namely supplying new variables to ML models. To better understand the prospects of ML in transplantation, we compared ML to conventional regression in a ""common"" analytic task: predicting kidney transplant outcomes using national registry data. We studied 133,431 adult deceased-donor kidney transplant recipients between 2005-2017. Transplant centers were randomly divided into 70% training set (190 centers/97787 recipients) and 30% validation set (82 centers/35644 recipients). Using the training set, we performed regression and ML procedures (gradient boosting [GB] and random forests [RF]) to predict delayed graft function, one-year acute rejection, death-censored graft failure, all-cause graft failure, and death. Their performances were compared on the validation set using C-statistics. In predicting rejection, regression (C= 0.601  0.611 0.621  ) actually outperformed GB (C= 0.581  0.591 0.601  ) and RF (C= 0.569  0.579 0.589  ). For all other outcomes, the C-statistics were nearly identical across methods (delayed graft function, 0.717-0.723; death-censored graft failure, 0.637-0.642; all-cause graft failure, 0.633-0.635; and death, 0.705-0.708). Given its shortcomings in model interpretability and hypothesis testing, ML is advantageous only when it clearly outperforms conventional regression; in the case of transplant outcomes prediction, ML seems more hype than helpful.",2020,"For all other outcomes, the C-statistics were nearly identical across methods (delayed graft function, 0.717-0.723; death-censored graft failure, 0.637-0.642; all-cause graft failure, 0.633-0.635; and death, 0.705-0.708).","['Transplant centers', '133,431 adult deceased-donor kidney transplant recipients between 2005-2017', 'Transplant Outcomes']",['Machine Learning'],[],"[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0260788', 'cui_str': 'Donor of kidney for transplant'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}]",[],133431.0,0.0436262,"For all other outcomes, the C-statistics were nearly identical across methods (delayed graft function, 0.717-0.723; death-censored graft failure, 0.637-0.642; all-cause graft failure, 0.633-0.635; and death, 0.705-0.708).","[{'ForeName': 'Sunjae', 'Initials': 'S', 'LastName': 'Bae', 'Affiliation': 'Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Allan B', 'Initials': 'AB', 'LastName': 'Massie', 'Affiliation': 'Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Caffo', 'Affiliation': 'Department of Biostatistics, Johns Hopkins School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Kyle R', 'Initials': 'KR', 'LastName': 'Jackson', 'Affiliation': 'Department of Surgery, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Dorry L', 'Initials': 'DL', 'LastName': 'Segev', 'Affiliation': 'Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, MD, USA.'}]",Transplant international : official journal of the European Society for Organ Transplantation,['10.1111/tri.13695']
2347,32781286,"Impact of the Support, Educate, Empower Personalized Glaucoma Coaching Program Pilot Study on Eye Drop Instillation Technique and Self-efficacy.","PURPOSE


To assess the Support, Educate, Empower (SEE) personalized glaucoma coaching program impact on (1) eye drop instillation technique and (2) eye drop instillation self-efficacy.
DESIGN


Prospective pre-post pilot study.
PARTICIPANTS


Patients with a diagnosis of glaucoma or ocular hypertension taking ≥1 glaucoma medication, ≥40 years old, spoke English, self-administered their eye drops, and ≤80% adherent to their glaucoma medication by electronic monitoring.
METHODS


Eye drop administration was video recorded before the first SEE in-person coaching session, which included teaching eye drop instillation techniques using a motivational interviewing-based approach. At the third and final in-person counseling session 6 months later, eye drop administration was video recorded. Participants' self-efficacy was assessed using the validated Eye Drop Technique Self-Efficacy Scale (EDTSES) survey at baseline and 1 month after completion of the program. Before and after intervention videos were assessed by an observer masked to time point. Before versus after intervention comparisons were made using McNemar's and paired t tests.
MAIN OUTCOME MEASURES


The main outcome was change in participants' eye drop instillation technique as measured by (1) accuracy of an eye drop landing on the eye, (2) ability to instill an eye drop on the first attempt, and (3) contaminating the bottle by contact with ocular surface, eyelashes, and skin. The secondary outcome measure was before versus after change in the EDTSES score (6 items, each assessed on a 3-point Likert scale, with higher scores indicating better self-efficacy).
RESULTS


Thirty-nine participants completed the SEE intervention, 38 with before and after EDTSES scores and 31 with video recordings. Six of 31 participants instilling drops outside the eye before intervention improved their technique after intervention, whereas 2 participants worsened (P = 0.157). From before to after intervention, participants demonstrated significant improvement in not touching the ocular surface (P = 0.046), the eyelashes (P = 0.020), or the skin (P = 0.025) with the bottle tip. A significant increase was found in eye drop instillation self-efficacy from an average score of 2.6 (standard deviation [SD], 0.3) to 2.8 (SD, 0.2) on the EDTSES score (P = 0.007).
CONCLUSIONS


The SEE program significantly decreased eye drop bottle contamination, increased eye drop instillation self-efficacy, and demonstrated an insignificant increase in ability to instill drops successfully and accurately.",2020,"From before to after intervention, participants demonstrated significant improvement in not touching the ocular surface (P = 0.046), the eyelashes (P = 0.020), or the skin (P = 0.025) with the bottle tip.","['Patients with a diagnosis of glaucoma or ocular hypertension taking ≥1 glaucoma medication, ≥40 years old, spoke English, self-administered their eye drops, and ≤80% adherent to their glaucoma medication by electronic monitoring']",['motivational interviewing-based approach'],"['eye drop instillation self-efficacy', 'eye drop bottle contamination', 'validated Eye Drop Technique Self-Efficacy Scale (EDTSES) survey', '3-point Likert scale', 'not touching the ocular surface', ""participants' eye drop instillation technique as measured by (1) accuracy of an eye drop landing on the eye, (2) ability to instill an eye drop on the first attempt, and (3) contaminating the bottle by contact with ocular surface, eyelashes, and skin"", 'self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0336646', 'cui_str': 'Electronic monitor'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C4727872', 'cui_str': 'Eye drop instillation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1720298', 'cui_str': 'Instill'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0015422', 'cui_str': 'Structure of eyelash'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",39.0,0.0435546,"From before to after intervention, participants demonstrated significant improvement in not touching the ocular surface (P = 0.046), the eyelashes (P = 0.020), or the skin (P = 0.025) with the bottle tip.","[{'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Schneider', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Cecilia N', 'Initials': 'CN', 'LastName': 'Hollenhorst', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Autumn N', 'Initials': 'AN', 'LastName': 'Valicevic', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Niziol', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Musch', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan Medical School, Ann Arbor, Michigan; Department of Epidemiology, University of Michigan School of Public Health, Ann Arbor, Michigan.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Cain', 'Affiliation': 'Department of Mechanical Engineering, University of Michigan School of Engineering, Ann Arbor, Michigan.'}, {'ForeName': 'Paula-Anne', 'Initials': 'PA', 'LastName': 'Newman-Casey', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan Medical School, Ann Arbor, Michigan. Electronic address: panewman@med.umich.edu.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2020.08.003']
2348,33050752,Hyperbaric oxygen for severe traumatic brain injury: a randomized trial.,"OBJECTIVE


The present study aimed to explore the effects of hyperbaric oxygen therapy on the prognosis and neurological function of patients with severe traumatic brain injury.
METHODS


A prospective study was carried out in 88 patients diagnosed with severe brain injury at our hospital and they were enrolled as research participants and randomly assigned to control and experimental groups (n = 44 per group) using a random number table method. Both groups underwent routine treatment. Patients in the experimental group were administered hyperbaric oxygen therapy approximately 1 week after admission when their vital signs had stabilized.
RESULTS


No significant intergroup differences were observed in the Glasgow Coma Scale (GCS) and U.S. National Institutes of Health Stroke Scale (NIHSS) scores before treatment. However, after oxygen treatment, compared with the control group, the experimental group showed higher GCS and lower NIHSS scores. The GCS score at admission, tracheotomy status, and first hyperbaric oxygen therapy duration were independent prognostic factors in patients with severe traumatic brain injury.
CONCLUSION


Hyperbaric oxygen therapy may promote recovery of neurological function and improve the cognitive function and prognosis of patients with severe traumatic brain injury.",2020,"However, after oxygen treatment, compared with the control group, the experimental group showed higher GCS and lower NIHSS scores.","['patients with severe traumatic brain injury', 'severe traumatic brain injury', '88 patients diagnosed with severe brain injury at our hospital and they were enrolled as research participants']","['Hyperbaric oxygen therapy', 'hyperbaric oxygen therapy', 'Hyperbaric oxygen']","['Glasgow Coma Scale (GCS) and U.S. National Institutes of Health Stroke Scale (NIHSS) scores', 'GCS and lower NIHSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",88.0,0.0440812,"However, after oxygen treatment, compared with the control group, the experimental group showed higher GCS and lower NIHSS scores.","[{'ForeName': 'Xianliang', 'Initials': 'X', 'LastName': 'Zhong', 'Affiliation': ""Department of Emergency, Shenzhen People's Hospital, The Second Clinical Medical College of Jinan University, The First Affiliated Hospital of Southern University of Science and Technology, Shenzhen, Guangdong, China.""}, {'ForeName': 'Aijun', 'Initials': 'A', 'LastName': 'Shan', 'Affiliation': ""Department of Emergency, Shenzhen People's Hospital, The Second Clinical Medical College of Jinan University, The First Affiliated Hospital of Southern University of Science and Technology, Shenzhen, Guangdong, China.""}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Emergency, Shenzhen People's Hospital, The Second Clinical Medical College of Jinan University, The First Affiliated Hospital of Southern University of Science and Technology, Shenzhen, Guangdong, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': ""Department of Neurosurgery, Shenzhen People's Hospital, The Second Clinical Medical College of Jinan University, The First Affiliated Hospital of Southern University of Science and Technology, Shenzhen, Guangdong, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Long', 'Affiliation': ""Department of Hyperbaric Oxygen, Shenzhen People's Hospital, The Second Clinical Medical College of Jinan University, The First Affiliated Hospital of Southern University of Science and Technology, Shenzhen , Guangdong, China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': ""Department of Emergency, Shenzhen People's Hospital, The Second Clinical Medical College of Jinan University, The First Affiliated Hospital of Southern University of Science and Technology, Shenzhen, Guangdong, China.""}]",The Journal of international medical research,['10.1177/0300060520939824']
2349,33050753,Effects of sevoflurane and propofol anesthesia on intraoperative endothelial cell function in patients undergoing laparoscopic cholecystectomy.,"OBJECTIVES


To investigate the effects of sevoflurane and propofol anesthesia on inflammatory or anti-inflammatory responses in patients undergoing laparoscopic cholecystectomy (LC).
METHODS


Patients undergoing LC (n = 23) were divided into sevoflurane (S) (n = 11) and propofol (P) (n = 12) anesthesia groups. A blood sample was taken before induction (T0), after induction but before pneumoperitoneum (T1), 15 minutes after pneumoperitoneum (T2), immediately after extubation (T3), and 30 minutes after extubation (T4). P-selectin-positive platelets and intercellular cell adhesion molecule-1 (ICAM-1)-positive lymphocytes, and plasma P-selectin, ICAM-1 and thrombomodulin (TM) levels were analyzed.
RESULTS


Sevoflurane significantly increased P-selectin expression in platelets at T2, T3, and T4 and in plasma at T1, T2, T3, and T4, but it did not affect ICAM-1 and TM. Propofol had no significant effects on P-selectin, ICAM-1, and TM expression during anesthesia and surgery. P-selectin, ICAM-1, and TM expression was higher in the S compared with P group at T1, T2, and T3 for platelet P-selectin; T2 and T4 for plasma P-selectin; T1 and T2 for lymphocyte ICAM-1; and T1, T2, and T3 for plasma TM.
CONCLUSIONS


Propofol anesthesia can delay the inflammatory reactions during laparoscopic surgery and better maintain the structure stability and function in vascular endothelial cells.",2020,"P-selectin, ICAM-1, and TM expression was higher in the S compared with P group at T1, T2, and T3 for platelet P-selectin; T2 and T4 for plasma P-selectin; T1 and T2 for lymphocyte ICAM-1; and T1, T2, and T3 for plasma TM.
","['patients undergoing laparoscopic cholecystectomy', 'patients undergoing laparoscopic cholecystectomy (LC', 'Patients undergoing LC (n\u2009=\u200923']","['sevoflurane and propofol anesthesia', 'sevoflurane (S) (n\u2009=\u200911) and propofol (P) (n\u2009=\u200912) anesthesia groups', 'Propofol anesthesia', 'Sevoflurane', 'Propofol']","['intraoperative endothelial cell function', 'P-selectin expression', 'plasma P-selectin, ICAM-1 and thrombomodulin (TM) levels', 'inflammatory or anti-inflammatory responses', 'P-selectin, ICAM-1, and TM expression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0242565', 'cui_str': 'Intercellular Adhesion Molecules'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]",,0.0458643,"P-selectin, ICAM-1, and TM expression was higher in the S compared with P group at T1, T2, and T3 for platelet P-selectin; T2 and T4 for plasma P-selectin; T1 and T2 for lymphocyte ICAM-1; and T1, T2, and T3 for plasma TM.
","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Anesthesia, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesia, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesia, Zhongshan Hospital, Fudan University, Shanghai, China.'}]",The Journal of international medical research,['10.1177/0300060520918407']
2350,33050760,A pooled safety analysis of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis treated over a median of 2 years.,"Objective:  To evaluate the safety of peficitinib for treatment of rheumatoid arthritis (RA) in Asian patients. Methods:  Safety data from one Phase 2b, two Phase 3, and one open-label long-term extension study [data cut-off May 31, 2018] were pooled into Phase 3 studies (peficitinib 100 and 150 mg/day, and placebo) and Phase 2/3 studies (all peficitinib-treated patients). Incidence rates per 100 patient-years (PY) of adverse events (AEs) of special interest were calculated. Results:  Overall, 1,052 patients received peficitinib for 2,336.3 PY of exposure (median 2.1 years); 4 deaths occurred, including 1 death after the studies. AE incidence was similar across peficitinib 100 and 150 mg/day groups (Phase 3 studies). Respective peficitinib and placebo incidence rates (95% confidence interval) per 100 PY were 2.9 (1.9, 4.6) and 0.0 for serious infections, 5.7 (4.2, 7.9) and 2.3 (0.6, 9.4) for herpes zoster-related disease, and 0.6 (0.2, 1.6) and 1.2 (0.2, 8.3) for malignancies (excluding non-melanoma skin cancer) (Phase 3 studies), and 0.1 (0.0, 0.3) for venous thromboembolism in all peficitinib-treated patients (Phase 2/3 studies). Conclusions:  Peficitinib was well tolerated in Asian patients with RA over a median of 2 years, with no observed dose or temporal dependency for AEs with prolonged administration.",2020,"Respective peficitinib and placebo incidence rates (95% confidence interval) per 100 PY were 2.9 (1.9, 4.6) and 0.0 for serious infections, 5.7 (4.2, 7.9) and 2.3 (0.6, 9.4) for herpes zoster-related disease, and 0.6 (0.2, 1.6) and 1.2 (0.2, 8.3) for malignancies (excluding non-melanoma skin cancer)","['Asian patients with rheumatoid arthritis treated over a median of 2 years', 'Asian patients with RA', 'Asian patients']","['peficitinib (ASP015K', 'placebo', 'peficitinib']","['Respective peficitinib and placebo incidence rates', 'AE incidence', 'Incidence rates', 'venous thromboembolism', 'tolerated']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4505522', 'cui_str': 'peficitinib'}, {'cui': 'C4505523', 'cui_str': 'ASP015K'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4505522', 'cui_str': 'peficitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",,0.140023,"Respective peficitinib and placebo incidence rates (95% confidence interval) per 100 PY were 2.9 (1.9, 4.6) and 0.0 for serious infections, 5.7 (4.2, 7.9) and 2.3 (0.6, 9.4) for herpes zoster-related disease, and 0.6 (0.2, 1.6) and 1.2 (0.2, 8.3) for malignancies (excluding non-melanoma skin cancer)","[{'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Division of Rheumatology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Rokuda', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Izutsu', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Kaneko', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Musashi', 'Initials': 'M', 'LastName': 'Fukuda', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kato', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}]",Modern rheumatology,['10.1080/14397595.2020.1836789']
2351,33050893,"Oral health behavior among school children aged 11-13 years in Saveh, Iran: an evaluation of a theory-driven intervention.","BACKGROUND


Good oral health (OH) is essential for physical, social, mental health, and overall quality of life. This study assessed the usefulness of the theory of planned behavior (TPB) in changing oral health-related behaviors among school children aged 11-13 years in Saveh, Iran.
METHODS


In this descriptive before and after study, participants were sixth-grade students at single sex primary schools in Saveh city, Iran. We recruited 356 school children in 2019. Using simple random sampling, a male and a female school per district were allocated to the experimental group and the remaining schools to the control group. Our planned oral health education consisted of four one-hour training sessions over 1 week. The first session familiarized the participants with important information about OH. In the second session, we applied a brain storming exercise to identify the benefits and barriers to flossing and brushing. In the third session, a short film about correct brushing and dental flossing technique was shown and research team also used role-playing to correct any mistakes. In the final session students were taught about the importance and the application of OH planning and given forms to help plan for brushing.
RESULTS


Participants for the study included 356 students (180 in the experimental group and 176 in the control group) who completed the post-test questionnaire. The mean age ± standard deviation was 11.55 years ±0.93 in the experimental group and 11.58 years ±1.01 in the control group. After the intervention, the paired t-test indicated a significant difference between the mean and standard deviation of the action plan and coping plan constructs in the experimental group before and after the intervention (p < 0.05). Covariance analysis indicated a significant difference between scores of intervention and control groups under statistical control of post-test in two groups (covariate) after a peer-led education program (post-test) (p < 0.05).
CONCLUSION


A shortage of professional health workers in education settings together with the ease, usefulness and low-cost of this peer-led method, suggest further steps should be taken to implement it more widely to improve and enhance primary school aged students' oral health behavior.",2020,"Covariance analysis indicated a significant difference between scores of intervention and control groups under statistical control of post-test in two groups (covariate) after a peer-led education program (post-test) (p < 0.05).
","['participants were sixth-grade students at single sex primary schools in Saveh city, Iran', '356 school children in 2019', 'school children aged 11-13\u2009years in Saveh, Iran', 'male and a female school per district', 'Participants for the study included 356 students (180 in the experimental group and 176 in the control group) who completed the post-test questionnaire', ""primary school aged students' oral health behavior""]","['OH planning and given forms to help plan for brushing', 'planned behavior (TPB']","['Oral health behavior', 'mean age\u2009±\u2009standard deviation', 'mean and standard deviation of the action plan and coping plan constructs']","[{'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018727', 'cui_str': 'Health Planning'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}]",356.0,0.0209224,"Covariance analysis indicated a significant difference between scores of intervention and control groups under statistical control of post-test in two groups (covariate) after a peer-led education program (post-test) (p < 0.05).
","[{'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Karimy', 'Affiliation': 'Department of Public Health, Faculty of Health, Social Determinants of Health Research Center, Saveh University of medical sciences, Saveh, Iran.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Higgs', 'Affiliation': 'Department of Public Health, School of Psychology and Public Health, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Shaghaygh Solayman', 'Initials': 'SS', 'LastName': 'Abadi', 'Affiliation': 'Department of Public Health, Faculty of Health, Social Determinants of Health Research Center, Saveh University of medical sciences, Saveh, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Armoon', 'Affiliation': 'Department of Public Health, Faculty of Health, Social Determinants of Health Research Center, Saveh University of medical sciences, Saveh, Iran. Bahramarmun@gmail.com.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Araban', 'Affiliation': 'Department of health education and promotion, Social Determinants of Health Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Rouhani', 'Affiliation': 'Internal medicine department, faculty of medicine, Arak University of medical sciences, Arak, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Zamani-Alavijeh', 'Affiliation': 'Department of health education and promotion, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",BMC pediatrics,['10.1186/s12887-020-02381-6']
2352,33050900,"CASCADE: a phase 2, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the effect of tezepelumab on airway inflammation in patients with uncontrolled asthma.","BACKGROUND


Patients with severe, uncontrolled asthma, particularly those with a non-eosinophilic phenotype, have a great unmet need for new treatments that act on a broad range of inflammatory pathways in the airway. Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin, an epithelial cytokine. In the PATHWAY phase 2b study (NCT02054130), tezepelumab reduced exacerbations by up to 71% in adults with severe, uncontrolled asthma, irrespective of baseline eosinophilic inflammatory status. This article reports the design and objectives of the phase 2 CASCADE study.
METHODS


CASCADE is an ongoing exploratory, phase 2, randomized, double-blind, placebo-controlled, parallel-group study aiming to assess the anti-inflammatory effects of tezepelumab 210 mg administered subcutaneously every 4 weeks for 28 weeks in adults aged 18-75 years with uncontrolled, moderate-to-severe asthma. The primary endpoint is the change from baseline to week 28 in airway submucosal inflammatory cells (eosinophils, neutrophils, T cells and mast cells) from bronchoscopic biopsies. Epithelial molecular phenotyping, comprising the three-gene-mean technique, will be used to assess participants' type 2 (T2) status to enable evaluation of the anti-inflammatory effect of tezepelumab across the continuum of T2 activation. Other exploratory analyses include assessments of the impact of tezepelumab on airway remodelling, including reticular basement membrane thickening and airway epithelial integrity. At the onset of the COVID-19 pandemic, the protocol was amended to address the possibility that site visits would be limited. The amendment allowed for: at-home dosing of study drug by a healthcare professional, extension of the treatment period by up to 6 months so patients are able to attend an onsite visit to undergo the end-of-treatment bronchoscopy, and replacement of final follow-up visits with a virtual or telephone visit.
DISCUSSION


CASCADE aims to determine the mechanisms by which tezepelumab improves clinical asthma outcomes by evaluating the effect of tezepelumab on airway inflammatory cells and remodelling in patients with moderate-to-severe, uncontrolled asthma. An important aspect of this study is the evaluation of the anti-inflammatory effect of tezepelumab across patients with differing levels of eosinophilic and T2 inflammation.
TRIAL REGISTRATION


NCT03688074 (ClinicalTrials.gov). Registered 28 September 2018.",2020,"Other exploratory analyses include assessments of the impact of tezepelumab on airway remodelling, including reticular basement membrane thickening and airway epithelial integrity.","['patients with moderate-to-severe, uncontrolled asthma', 'Patients with severe, uncontrolled asthma, particularly those with a non-eosinophilic phenotype', 'patients with uncontrolled asthma', 'adults with severe, uncontrolled asthma, irrespective of baseline eosinophilic inflammatory status', 'patients with differing levels of eosinophilic and T2 inflammation', 'adults aged 18-75\u2009years with uncontrolled, moderate-to-severe asthma']","['Tezepelumab', 'placebo', 'tezepelumab']","['airway inflammation', 'change from baseline to week 28 in airway submucosal inflammatory cells (eosinophils, neutrophils, T cells and mast cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4550163', 'cui_str': 'tezepelumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0024880', 'cui_str': 'Mast cell'}]",,0.343128,"Other exploratory analyses include assessments of the impact of tezepelumab on airway remodelling, including reticular basement membrane thickening and airway epithelial integrity.","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Emson', 'Affiliation': 'Translational Science and Experimental Medicine, Research & Early Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA. Claire.emson@astrazeneca.com.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Diver', 'Affiliation': 'University of Leicester, Leicester, UK.'}, {'ForeName': 'Latifa', 'Initials': 'L', 'LastName': 'Chachi', 'Affiliation': 'University of Leicester, Leicester, UK.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Megally', 'Affiliation': 'Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Cherrie', 'Initials': 'C', 'LastName': 'Small', 'Affiliation': 'Development Operations, BioPharmaceuticals R&D, AstraZeneca, Mississauga, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Downie', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Jane R', 'Initials': 'JR', 'LastName': 'Parnes', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Bowen', 'Affiliation': 'Biometrics, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Colice', 'Affiliation': 'Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Chris E', 'Initials': 'CE', 'LastName': 'Brightling', 'Affiliation': 'University of Leicester, Leicester, UK.'}]",Respiratory research,['10.1186/s12931-020-01513-x']
2353,33050917,Evaluating the use of the EORTC patient-reported outcome measures for improving inter-rater reliability of CTCAE ratings in a mixed population of cancer patients: study protocol for a randomized controlled trial.,"BACKGROUND


In oncology, detection and tracking of adverse events are of top priority and rely mostly on the Common Terminology Criteria for Adverse Events (CTCAE). Besides, clinical trials use as well patient-reported outcomes (PROs) to assess those adverse events, which are only accessible through patient self-reporting, such as fatigue, pain, and sleep disorders. Especially those issues that are not visible from the outside are often misinterpreted and underestimated by mere provider ratings. This trial aims at evaluating the impact of providing PRO data to providers on the accuracy of adverse event assessment in terms of inter-rater reliability of CTCAE ratings.
METHODS


The trial uses a cross-sectional, unblinded, randomized controlled trial design with two trial arms and a single assessment time point. Eligible patients (aged 18 and above, any cancer diagnosis, currently under treatment, inpatient or day clinic setting, present symptom burden, no psychiatric or mental problems, written informed consent) complete an electronic version of the EORTC QLQ-C30 and 16 additional questions taken from the EORTC Item Library. PRO data is immediately processed and made available to CTCAE rating providers for conducting their ratings during the medical encounter. Patients are randomly assigned 1:1 to the intervention group (providers see PRO results on the same screen as the CTCAE rating) and the control group (no access to PRO data during the CTCAE rating). A superiority analysis will compare the inter-rater reliability (using intra-class correlation (ICC) coefficients) between the control and the intervention groups for each adverse event evaluated.
DISCUSSION


The presented trial will demonstrate potential benefits of using PRO measures to improve the reliability of CTCAE ratings in cancer trials and the identification of adverse events. The new insights gained may lead to a new strategy for evaluating adverse events in clinical trials by combining patient and provider ratings. This might also have implications for daily clinical practice and cancer registries.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04066868 . Registered on August 26, 2019. Competence Center for Clinical Trials of the Medical University of Innsbruck 20190513-2007. Registered on May 14, 2019. (version 6.0, March 18, 2019).",2020,The presented trial will demonstrate potential benefits of using PRO measures to improve the reliability of CTCAE ratings in cancer trials and the identification of adverse events.,"['Eligible patients (aged 18 and above, any cancer diagnosis, currently under treatment, inpatient or day clinic setting, present symptom burden, no psychiatric or mental problems, written informed consent) complete an electronic version of the EORTC QLQ-C30 and 16 additional questions taken from the EORTC Item Library', 'cancer patients']",['intervention group (providers see PRO'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0023621', 'cui_str': 'Library'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033382', 'cui_str': 'Proline'}]",[],,0.150855,The presented trial will demonstrate potential benefits of using PRO measures to improve the reliability of CTCAE ratings in cancer trials and the identification of adverse events.,"[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Wintner', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry I, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria. lisa.wintner@tirol-kliniken.at.'}, {'ForeName': 'Johannes M', 'Initials': 'JM', 'LastName': 'Giesinger', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry I, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Sztankay', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry I, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bottomley', 'Affiliation': 'European Organisation for Research and Treatment of Cancer (EORTC Headquarters), Avenue E. Mounier 83/11, 1200, Brussels, Belgium.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Holzner', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry I, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04745-w']
2354,33040141,Preoperative Acute Pain Is Associated with Postoperative Delirium.,"BACKGROUND


Studies have provided some evidence that pain is a risk factor for postoperative delirium (POD). Therefore, we investigated the relationship between preoperative pain and POD after noncardiac surgery.
METHODS


POD was assessed with the Montreal Cognitive Assessment, and preoperative cognition was assessed with the Mini-Mental State Examination. Plasma C-reactive protein (CRP) was detected by enzyme-linked immunosorbent assay before surgery. Preoperative pain was classified by its duration before surgery as chronic pain (lasting more than 1 month), acute pain (lasting less than 1 month), or no pain (no obvious pain). Multiple linear regression was used to adjust for confounding.
RESULTS


From October 15, 2018, through August 12, 2019, a total of 67 patients were randomized; 7 were excluded because they were discharged before the seventh postoperative day. The prevalence of POD was significantly higher in the acute pain group (13 of 20; 65%) than in the chronic pain group (5 of 20; 25%) or the no pain group (6 of 20; 30%) (P = 0.019), indicating that delirium is associated with preoperative acute pain. The plasma level of preoperative CRP was also higher in the acute pain group than in the other two groups (mean [interquartile range]: 10.7 [3.3, 29.3] vs 1 [0.5, 3.8]mg/l; P < 0.001), suggesting that elevated preoperative plasma levels of CRP were associated with delirium.
CONCLUSIONS


Preoperative acute pain was associated with POD, and increased plasma levels of CRP provide a marker. In addition, we found that illiteracy and advanced age were risk factors for POD.",2020,"The prevalence of POD was significantly higher in the acute pain group (13 of 20; 65%) than in the chronic pain group (5 of 20; 25%) or the no pain group (6 of 20; 30%) (P = 0.019), indicating that delirium is associated with preoperative acute pain.","['From October 15, 2018, through August 12, 2019, a total of 67 patients were randomized; 7 were excluded because they were discharged before the seventh postoperative day']",[],"['Montreal Cognitive Assessment, and preoperative cognition', 'prevalence of POD', 'Preoperative pain', 'acute pain', 'Plasma C-reactive protein (CRP', 'plasma level of preoperative CRP']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0303134', 'cui_str': 'Beryllium-7'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],"[{'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",67.0,0.258125,"The prevalence of POD was significantly higher in the acute pain group (13 of 20; 65%) than in the chronic pain group (5 of 20; 25%) or the no pain group (6 of 20; 30%) (P = 0.019), indicating that delirium is associated with preoperative acute pain.","[{'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Jiangnan University (Original Department at Wuxi Third People's Hospital), Wuxi, Jiangsu, China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Fujian Maternity and Child Health Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'Qizhong', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': ""Women and Children's Hospital, School of Medicine, Xiamen University, Xiamen, Fujian, China.""}, {'ForeName': 'Xuliang', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Math and Statistics School of Nanjing Audit University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital of Nanjing Medical University, Wuxi, Jiangsu, China.""}, {'ForeName': 'Guowei', 'Initials': 'G', 'LastName': 'Qin', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital of Nanjing Medical University, Wuxi, Jiangsu, China.""}, {'ForeName': 'Shunmei', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital of Nanjing Medical University, Wuxi, Jiangsu, China.""}, {'ForeName': 'Dongxiao', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': ""The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi, Jiangsu, China.""}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa314']
2355,33040158,Small soft tissue tension changes do not affect patient-reported outcomes one year after primary TKA.,"BACKGROUND


Adequate soft tissue tension and balance is paramount to achieve favourable outcomes of total knee arthroplasty (TKA). Implant manufacturers offer 1-mm liner increments to fine-tune ligament tension and balance. In this study, we assessed if soft tissue tension changes introduced by minimal changes in liner thicknesses affect early patient reported outcomes.
METHODS


Eighty-nine patients undergoing 99 primary, elective TKAs by a single surgeon were included. After achieving adequate ligament balance, the first 50 knees received an insert that would allow 2-3 mm of medial and lateral opening (control group), whereas the last 49 received an insert which was 1 mm thicker, resulting in a slight increase in ligament tension (study group). Sensor technology was used to record compartmental loads. Knee Society Score (KSS), KOOS Jr., and ROM were recorded pre-operatively, six weeks, four and 12 months post-operatively. The Forgotten Joint Score (FJS) was administered four and 12 months post-operatively.
RESULTS


No differences were observed in demographic variables, pre-operative outcome scores, and ROM measures between groups. Six weeks post-operatively, there was no statistically significant difference in the outcome variables. Four months post-operatively, statistically significant differences were only observed in KOOS Jr. (79 and 73.6; p = 0.05), and FJS (59.9 and 45.5; p < 0.01); all of which favoured the control group. There was no difference in the outcome variables at 12 months.
CONCLUSION


Minor changes in soft tissue tension induced by 1-mm changes in liner thickness resulted in clinically meaningful differences favouring the control group four months post-operatively, but in no clinically noticeable differences 12 months post-operatively. It is possible that lower soft tissue tension may lead to transient improvement in patient-reported early outcomes.",2020,"No differences were observed in demographic variables, pre-operative outcome scores, and ROM measures between groups.","['total knee arthroplasty (TKA', 'Eighty-nine patients undergoing 99 primary, elective TKAs by a single surgeon were included']",[],"['liner thickness', 'demographic variables, pre-operative outcome scores, and ROM measures', 'Forgotten Joint Score (FJS', 'Knee Society Score (KSS), KOOS Jr., and ROM', 'FJS', 'soft tissue tension']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0181663', 'cui_str': 'Liner'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4759288', 'cui_str': 'Forgotten Joint Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0233494', 'cui_str': 'Tension'}]",89.0,0.0351025,"No differences were observed in demographic variables, pre-operative outcome scores, and ROM measures between groups.","[{'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Krell', 'Affiliation': 'Department of Orthopaedic Surgery, Hospital for Special Surgery, Weill Medical College of Cornell University, 535 East 70th Street, New York, NY, 10021, USA.'}, {'ForeName': 'Amethia', 'Initials': 'A', 'LastName': 'Joseph', 'Affiliation': 'Department of Orthopaedic Surgery, Hospital for Special Surgery, Weill Medical College of Cornell University, 535 East 70th Street, New York, NY, 10021, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Department of Biostatistics, Hospital for Special Surgery, Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Gonzalez Della Valle', 'Affiliation': 'Department of Orthopaedic Surgery, Hospital for Special Surgery, Weill Medical College of Cornell University, 535 East 70th Street, New York, NY, 10021, USA. gonzaleza@hss.edu.'}]",International orthopaedics,['10.1007/s00264-020-04839-9']
2356,33040236,Postoperative inguinal pain and disability after Lichtenstein versus ONSTEP hernia repair: analysis of responses to the inguinal pain questionnaire in Spanish.,"PURPOSE


To validate the Inguinal Pain Questionnaire (IPQ) in the Spanish Language and test its use in a randomized controlled trial (RCT) of hernia repair using the Lichtenstein technique vs. the ONSTEP technique. We simplified the IPQ using a principal component analysis (PCA) approach as a secondary objective.
METHODS


The IPQ was translated into Spanish and validated in a cohort of 21 patients. Thereafter, 40 patients were randomized to undergo hernia repair by the Lichtenstein technique or the ONSTEP technique. IPQ and pain visual analogue (VAS) score trends over time were compared using a repeated-measures mixed-effects model.
RESULTS


The Spanish version of the IPQ showed an internal consistency similar to that of the original score. No significant differences were found in the IPQ responses, pain VAS, or the rate of self-reported pain between patients who underwent the Lichtenstein technique and those who underwent the ONSTEP technique. Following PCA analysis, the number of items on the IPQ was reduced from 18 to 10.
CONCLUSIONS


The Spanish version of the IPQ measures postoperative inguinal pain adequately. Based on our findings, the ONSTEP technique was not superior to the Lichtenstein technique. The simplified version of the IPQ is not significantly different from the full version and it is easier to complete.
CLINICAL TRIAL REGISTRATION


NCT04138329, registered on October 24, 2019.",2020,"No significant differences were found in the IPQ responses, pain VAS, or the rate of self-reported pain between patients who underwent the Lichtenstein technique and those who underwent the ONSTEP technique.","['40 patients were randomized to undergo', 'inguinal pain questionnaire in Spanish', '21 patients']","['hernia repair by the Lichtenstein technique or the ONSTEP technique', 'hernia repair using the Lichtenstein technique vs. the ONSTEP technique', 'Lichtenstein versus ONSTEP hernia repair']","['IPQ responses, pain VAS, or the rate of self-reported pain', 'IPQ and pain visual analogue (VAS) score', 'Postoperative inguinal pain and disability', 'Inguinal Pain Questionnaire (IPQ', 'number of items on the IPQ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}]","[{'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0239783', 'cui_str': 'Inguinal pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",40.0,0.0745365,"No significant differences were found in the IPQ responses, pain VAS, or the rate of self-reported pain between patients who underwent the Lichtenstein technique and those who underwent the ONSTEP technique.","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Aguilar-García', 'Affiliation': 'Division of General Surgery, Hospital Central ""Dr. Ignacio Morones Prieto"", 2395 Venustiano Carranza Ave., 78290, San Luis Potosi, SLP, Mexico.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Villafuerte-Fernandez', 'Affiliation': 'Division of General Surgery, Hospital Central ""Dr. Ignacio Morones Prieto"", 2395 Venustiano Carranza Ave., 78290, San Luis Potosi, SLP, Mexico.'}, {'ForeName': 'Perla I', 'Initials': 'PI', 'LastName': 'Ntezes-Hidalgo', 'Affiliation': 'Division of General Surgery, Hospital Central ""Dr. Ignacio Morones Prieto"", 2395 Venustiano Carranza Ave., 78290, San Luis Potosi, SLP, Mexico.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Meade-Aguilar', 'Affiliation': 'Division of General Surgery, Hospital Central ""Dr. Ignacio Morones Prieto"", 2395 Venustiano Carranza Ave., 78290, San Luis Potosi, SLP, Mexico.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Ramirez-GarciaLuna', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Universidad Autonoma de San Luis Potosi, 2405 Venustiano Carranza Ave., 78210, San Luis Potosi, SLP, Mexico. jose.ramirezgarcialuna@mail.mcgill.ca.'}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Martinez-Jimenez', 'Affiliation': 'Division of General Surgery, Hospital Central ""Dr. Ignacio Morones Prieto"", 2395 Venustiano Carranza Ave., 78290, San Luis Potosi, SLP, Mexico.'}]",Surgery today,['10.1007/s00595-020-02155-8']
2357,33040273,Comparison between bilateral implantation of a trifocal intraocular lens (Alcon Acrysof IQ® PanOptix) and extended depth of focus lens (Tecnis® Symfony® ZXR00 lens).,"PURPOSE


To compare the visual performance outcomes following bilateral cataract surgery using trifocal intraocular lens (Alcon Acrysof IQ® PanOptix) and extended depth of focus lens (Tecnis® Symfony® ZXR00 lens).
METHODS


In this prospective, non-randomized, comparative trial, a total of 40 subjects (80 eyes) were divided into two different groups and submitted to bilateral cataract surgery and implantation of the two different IOLs, Alcon Acrysof IQ® PanOptix® TNFT00 in group A and Tecnis® Symfony® ZXR00 lens (Johnson & Johnson Vision) in group B, was assessed. The uncorrected and corrected near (33 cm), intermediate (60 cm), and far (4 m) binocular visual acuity was measured, and visual binocular defocus curves were also measured in the photopic condition with a long-distance visual acuity and the qualitative visual function was assessed by NEI VFQ-25.
RESULTS


Group A comprised 20 patients; 11 women (55%) and 9 men (45%) with a mean age of 62.1 ± 5.4. In group B 20 patients were recruited; 12 women (60%) and 8 men (40%) with a mean age of 63.2 ± 6.1. The postoperatively calculated mean sphere was + 0.35 ± 0.12 D and - 0.14 ± 0.13 D in groups A and B, respectively. The postoperative uncorrected distance visual acuity (UDVA) as well as uncorrected intermediate visual acuity (UIVA) were statistically equal in both groups (P = 0.12, P = 0.17); meanwhile, the postoperative uncorrected near visual acuity (UNVA) was significantly better in patients with PanOptix IOL implantation (P = 0.01) compared to the binocular defocus curve; the results of the PanOptix group were better than the Symfony group in intermediate and near distance (P = 0.089, P = 0.001) and according to the VFQ-25 questionnaire, then ear vision score as well as sum score turned out to be significantly higher in groups A than B (P = 0.001 and P = 0.015, respectively).
CONCLUSION


Both strategies were able to provide good vision for far, intermediate and near distances.",2020,"The postoperative uncorrected distance visual acuity (UDVA) as well as uncorrected intermediate visual acuity (UIVA) were statistically equal in both groups (P = 0.12, P = 0.17); meanwhile, the postoperative uncorrected near visual acuity (UNVA) was significantly better in patients with PanOptix IOL implantation (P = 0.01) compared to the binocular defocus curve; the results of the PanOptix group were better than the Symfony group in intermediate and near distance (P = 0.089, P = 0.001) and according to the VFQ-25 questionnaire, then ear vision score as well as sum score turned out to be significantly higher in groups A than B (P = 0.001 and P = 0.015, respectively).
","['40 subjects (80 eyes', 'In group B 20 patients were recruited; 12 women (60%) and 8 men (40%) with a mean age of 63.2\u2009±\u20096.1', 'Group A comprised 20 patients; 11 women (55%) and 9 men (45%) with a mean age of 62.1\u2009±\u20095.4']","['bilateral implantation of a trifocal intraocular lens (Alcon Acrysof IQ® PanOptix', 'bilateral cataract surgery using trifocal intraocular lens (Alcon Acrysof IQ® PanOptix', 'bilateral cataract surgery and implantation of the two different IOLs, Alcon Acrysof IQ® PanOptix® TNFT00 in group A and Tecnis® Symfony® ZXR00 lens (Johnson & Johnson Vision']","['VFQ-25 questionnaire, then ear vision score', 'photopic condition with a long-distance visual acuity and the qualitative visual function', 'visual binocular defocus curves', 'uncorrected intermediate visual acuity (UIVA', 'postoperative uncorrected near visual acuity (UNVA', 'postoperative uncorrected distance visual acuity (UDVA', 'binocular visual acuity', 'visual performance outcomes']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C4517792', 'cui_str': '5.4'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0521707', 'cui_str': 'Bilateral cataracts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",40.0,0.0481988,"The postoperative uncorrected distance visual acuity (UDVA) as well as uncorrected intermediate visual acuity (UIVA) were statistically equal in both groups (P = 0.12, P = 0.17); meanwhile, the postoperative uncorrected near visual acuity (UNVA) was significantly better in patients with PanOptix IOL implantation (P = 0.01) compared to the binocular defocus curve; the results of the PanOptix group were better than the Symfony group in intermediate and near distance (P = 0.089, P = 0.001) and according to the VFQ-25 questionnaire, then ear vision score as well as sum score turned out to be significantly higher in groups A than B (P = 0.001 and P = 0.015, respectively).
","[{'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Farvardin', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars, Iran.'}, {'ForeName': 'Mohammadkarim', 'Initials': 'M', 'LastName': 'Johari', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars, Iran. mkjoharii@gmail.com.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Attarzade', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars, Iran.'}, {'ForeName': 'Feisal', 'Initials': 'F', 'LastName': 'Rahat', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Farvardin', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Farvardin', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars, Iran.'}]",International ophthalmology,['10.1007/s10792-020-01608-w']
2358,33040311,"The Effect of Low-Level Light Therapy on Capsaicin-Induced Peripheral and Central Sensitization in Healthy Volunteers: A Double-Blinded, Randomized, Sham-Controlled Trial.","INTRODUCTION


Several clinical trials have demonstrated that low-level light therapy (LLLT), a method of photobiomodulation, is an effective analgetic treatment. However, the mechanism of action has not yet been finally clarified. In particular, unanswered questions include whether it only affects peripheral or whether it also affects the spinal or supraspinal level. This study aimed to evaluate the effect of low-level light therapy on primary and secondary hyperalgesia in a human pain model.
METHODS


This study was planned as a randomized, sham-controlled, and double-blinded trial with repeated measures within subject design. Capsaicin was applied on both forearms of ten healthy volunteers to induce peripheral and central sensitization. One forearm was treated with low-level light therapy; the other served as sham control.
RESULTS


Low-level light therapy significantly increased the mechanical pain threshold, heat pain threshold, and decreased pain intensity.
CONCLUSIONS


Our data indicate that low-level light therapy is effective at reducing the heat and mechanical pain threshold in a human pain model, pointing to a significant modulating effect on peripheral and central sensitization. These effects-especially in the absence of reported side effects-make low-level light therapy a promising tool in pain management. The application of low-level light therapy to treat chronic pain should be considered for further clinical trials.",2020,"Our data indicate that low-level light therapy is effective at reducing the heat and mechanical pain threshold in a human pain model, pointing to a significant modulating effect on peripheral and central sensitization.","['ten healthy volunteers to induce peripheral and central sensitization', 'Healthy Volunteers']","['low-level light therapy', 'Capsaicin', 'Low-Level Light Therapy', 'low-level light therapy (LLLT']","['mechanical pain threshold, heat pain threshold, and decreased pain intensity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C2938905', 'cui_str': 'Central Sensitization'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C0234252', 'cui_str': 'Mechanical pain'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",10.0,0.106331,"Our data indicate that low-level light therapy is effective at reducing the heat and mechanical pain threshold in a human pain model, pointing to a significant modulating effect on peripheral and central sensitization.","[{'ForeName': 'Kordula', 'Initials': 'K', 'LastName': 'Lang-Illievich', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Raimund', 'Initials': 'R', 'LastName': 'Winter', 'Affiliation': 'Division of Plastic, Aesthetic and Reconstructive Surgery, Department of Surgery, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Rumpold-Seitlinger', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Schicho', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dorn', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Klivinyi', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Helmar', 'Initials': 'H', 'LastName': 'Bornemann-Cimenti', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria. helmar.bornemann@medunigraz.at.'}]",Pain and therapy,['10.1007/s40122-020-00205-0']
2359,33040439,A comparative study of 14-day dual therapy (esomeprazole and amoxicillin four times daily) and triple plus bismuth therapy for first-line Helicobacter pylori infection eradication: A randomized trial.,"BACKGROUND


Favorable outcomes in treating H pylori infection using ""dual therapy (proton pump inhibitor and amoxicillin four times daily)"" have attracted widespread attention. However, there are few reports, and the study results lack agreement. This study aimed to compare the eradication rate, safety, and compliance of naïve-treatment patients with H pylori infection on ""dual therapy"" with those on ""triple plus bismuth (TPB) therapy.""
METHODS


This is a non-inferior randomized controlled trial conducted on 760 patients with H pylori infection. The participants were randomly assigned to two eradication groups: dual therapy (esomeprazole 20 mg and amoxicillin 750 mg four times daily) and TPB therapy (esomeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and bismuth potassium citrate 220 mg twice daily) for 14 days. Safety and compliance were assessed within 3 days after eradication. Urea breath test was performed about 8 weeks after eradication to evaluate outcome. Antibiotic resistance and CYP2C19 polymorphism were determined.
RESULTS


Compared with TPB therapy, dual therapy had significantly higher eradication rates in intention-to-treat (87.1% vs 80.5%, rate difference 6.6%), modified intention-to-treat (90.9% vs 85.5%, 5.5%) and per-protocol (92.4% vs 87.8%, 4.7%) analyses, respectively. Adverse reactions in dual therapy group were significantly lower than TPB therapy group (17.6% vs 25.5%, P = .008), and dual therapy group had better compliance (96.3% vs 92.3%, P = .019). Antibiotic resistance and poor compliance were also associated with treatment failure.
CONCLUSIONS


Dual therapy (esomeprazole and amoxicillin four times daily) was non-inferior to, and even superior to TPB therapy as first-line H pylori eradication.",2020,"Compared with TPB therapy, dual therapy had significantly higher eradication rates in intention-to-treat (87.1% vs 80.5%, rate difference 6.6%), modified intention-to-treat (90.9% vs 85.5%, 5.5%) and per-protocol (92.4% vs 87.8%, 4.7%) analyses, respectively.","['naïve-treatment patients with H\xa0pylori infection on ""dual therapy"" with those on ""triple plus bismuth (TPB) therapy', 'first-line Helicobacter pylori infection eradication', '760 patients with H\xa0pylori infection']","['TPB therapy (esomeprazole 20\xa0mg, amoxicillin 1000\xa0mg, clarithromycin 500\xa0mg, and bismuth potassium citrate', 'triple plus bismuth therapy', 'TPB therapy, dual therapy', 'Dual therapy (esomeprazole and amoxicillin', 'dual therapy (proton pump inhibitor and amoxicillin', '14-day dual therapy (esomeprazole and amoxicillin', 'TPB therapy', 'dual therapy (esomeprazole 20\xa0mg and amoxicillin']","['modified intention-to-treat', 'eradication rates', 'Adverse reactions', 'Urea breath test', 'Antibiotic resistance and CYP2C19 polymorphism', 'eradication rate, safety, and compliance', 'Safety and compliance', 'Antibiotic resistance and poor compliance']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1146111', 'cui_str': 'Esomeprazole 20 MG'}, {'cui': 'C1126881', 'cui_str': 'Amoxicillin 1000 MG'}, {'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}, {'cui': 'C0137996', 'cui_str': 'potassium citrate'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance'}, {'cui': 'C3203672', 'cui_str': 'CYP2C19 polymorphism'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",760.0,0.0262944,"Compared with TPB therapy, dual therapy had significantly higher eradication rates in intention-to-treat (87.1% vs 80.5%, rate difference 6.6%), modified intention-to-treat (90.9% vs 85.5%, 5.5%) and per-protocol (92.4% vs 87.8%, 4.7%) analyses, respectively.","[{'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Baojun', 'Initials': 'B', 'LastName': 'Suo', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Xueli', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Zhanyue', 'Initials': 'Z', 'LastName': 'Niu', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}]",Helicobacter,['10.1111/hel.12762']
2360,33040465,Effects of vitamin D and calcium supplementation on bone mineral density among Thai youth using daily HIV pre-exposure prophylaxis.,"INTRODUCTION


Tenofovir disoproxil fumarate with emtricitabine (TDF/FTC) is used for HIV pre-exposure prophylaxis (PrEP). TDF may affect bone mineral density (BMD), particularly in youth who are at a stage of peak bone mass accrual. The objective of this study was to evaluate the effect of vitamin D and calcium supplementation on BMD among Thai youth receiving daily oral PrEP.
METHODS


This open-label randomized trial was conducted in male youth aged between 15 and 24 years. Participants were randomized to Arm A who received once-daily TDF/FTC plus vitamin D3 and calcium supplementation with meals twice daily (400 units of vitamin D3 and 1200 mg of elemental calcium/day) or Arm B who received once-daily TDF/FTC only. PrEP users were defined as taking at least two tablets/week (tenofovir-diphosphate level of >350 fmol/punch). Adherence to vitamin D/calcium supplementation was defined as self-reported adherence of >50%. Lumbar spine (L2-L4) BMD (LSBMD) was evaluated by dual-energy X-ray absorptiometry scan zero and six months after PrEP initiation.
RESULTS


From March 2019 to March 2020, 100 youth were enrolled. Baseline characteristics between the two arms were similar. Median (IQR) age was 18 (17 to 20) years. At entry, median (IQR) LSBMD z-score was -0.8 (-1.5 to -0.3), 17% had low LSBMD (Z-score < -2). The median amount of calcium intake from nutritional three-day recall was 167 (IQR 94 to 272) mg/day, 39% of participants had vitamin D deficiency, defined as 25(OH)D levels <20 IU/mL. At six months, 79 participants were evaluated. Of these, 42 (52%) were PrEP takers and 25 of 38 (66%) of arm A participants had good adherence to vitamin D/calcium supplementation. Significantly higher proportions of youth in arm A compared to arm B had >3% increase in LSBMD at month 6 compared to baseline (67.6% vs. 42.9% respectively; p = 0.03). There were significantly higher increases in LSBMD among youth with vitamin D deficiency who were supplemented; arm A + 0.05 (0 to 0.05) compared to arm B + 0.03 (-0.1 to 0.03), p = 0.04.
CONCLUSIONS


Increases in LSBMD over six months among youth using PrEP who received vitamin D/calcium supplementation was greater than those not supplemented. Long-term follow-up should be considered to explore long-term outcomes.",2020,Significantly higher proportions of youth in arm A compared to arm B had >3% increase in LSBMD at month 6 compared to baseline (67.6% vs. 42.9% respectively; p = 0.03).,"['male youth aged between 15 and 24\xa0years', 'From March 2019 to March 2020, 100 youth were enrolled', 'Thai youth receiving daily oral PrEP', 'Thai youth using daily HIV pre-exposure prophylaxis', '79 participants were evaluated']","['vitamin D and calcium supplementation', 'vitamin D/calcium supplementation', 'TDF', 'Tenofovir disoproxil fumarate with emtricitabine (TDF/FTC', 'TDF/FTC plus vitamin D3 and calcium supplementation with meals twice daily (400 units of vitamin D3 and 1200\xa0mg of elemental calcium/day) or Arm B who received once-daily TDF/FTC only']","['bone mineral density', 'bone mineral density (BMD', '25(OH)D levels', 'median amount of calcium intake', 'median (IQR) LSBMD z-score', 'LSBMD', 'Lumbar spine (L2-L4) BMD (LSBMD']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C1096319', 'cui_str': 'Prophylaxis against HIV infection'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0206682', 'cui_str': 'Follicular thyroid carcinoma'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4553624', 'cui_str': 'With meals'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",79.0,0.215788,Significantly higher proportions of youth in arm A compared to arm B had >3% increase in LSBMD at month 6 compared to baseline (67.6% vs. 42.9% respectively; p = 0.03).,"[{'ForeName': 'Krittaporn', 'Initials': 'K', 'LastName': 'Pornpaisalsakul', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Wipaporn Natalie', 'Initials': 'WN', 'LastName': 'Songtaweesin', 'Affiliation': 'Center of Excellence for Paediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Supatporn', 'Initials': 'S', 'LastName': 'Tepmongkol', 'Affiliation': 'Department of Radiology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Prissana', 'Initials': 'P', 'LastName': 'Wongharn', 'Affiliation': 'Center of Excellence for Paediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Surinda', 'Initials': 'S', 'LastName': 'Kawichai', 'Affiliation': 'Center of Excellence for Paediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Vichit', 'Initials': 'V', 'LastName': 'Suponsilchai', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Suvaporn', 'Initials': 'S', 'LastName': 'Anugulruengkitt', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Thanyawee', 'Initials': 'T', 'LastName': 'Puthanakit', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25624']
2361,33040561,Remifentanil injected during analepsia shortens length of postanesthesia care unit stay in patients undergoing laparoscopic surgery for endometrial cancer: a randomized controlled trial.,"BACKGROUND


To guarantee efficient operating room (OR) activity, tracheal extubation is often performed in the postanesthesia care unit (PACU). Therefore, the ability of PACU to accommodate postoperative patients is crucial. Optimizing extubation management may speed up the turnover of PACU beds. The aim of the present study was to investigate the effect of remifentanil, which is used during analepsia, on the length of PACU stay in patients undergoing laparoscopic surgery for endometrial cancer.
METHODS


In this prospective trial, we recruited a total of 99 patients, who were scheduled for laparoscopic surgery for endometrial cancer. At the end of the surgery, all patients were immediately transferred to the PACU and continued mechanical ventilation. Upon PACU admission, sputum aspiration was routinely performed. If the hemodynamic parameters fluctuated >30% of the baseline level, or patients moved unconsciously without reaching the criteria of extubation, a bolus injection of either 1 μg/kg remifentanil (Rem group, n=51) or propofol 1.0 mg/kg (Pro group, n=48) was randomly administered. The primary outcome was the duration of PACU stay. The secondary outcomes included time to respiratory breath recovery and time to extubation, along with bispectral index (BIS) values and hemodynamic status after remifentanil or propofol intervention. Times of repeated intervention, rescue administration of vasoactive drugs, and the incidence of adverse events were recorded. Visual analog scale and satisfaction scores at the time of PACU discharge were also evaluated.
RESULTS


The duration of PACU stay was shorter in the Rem group than in the Pro group [49 (46.47-51.06 minutes) vs. 62 minutes (60.75-69.29 minutes), P<0.0001]. Compared with the Pro group, the time to spontaneous breathing recovery, the time to extubation, and the incidence of hypoxemia after extubation were reduced in the Rem group (P<0.0001, P<0.0001, P=0.03, respectively). After anesthetic administration, the BIS value decreased less in the Rem group (P<0.0001); blood pressure and heart rate (HR) declined, but were comparable in both groups.
CONCLUSIONS


Remifentanil, which is injected during analepsia, significantly shortens the duration of PACU stay without increasing adverse events in the peri-extubation period.",2020,"After anesthetic administration, the BIS value decreased less in the Rem group (P<0.0001); blood pressure and heart rate (HR) declined, but were comparable in both groups.
","['patients undergoing laparoscopic surgery for endometrial cancer', '99 patients, who were scheduled for laparoscopic surgery for endometrial cancer']","['remifentanil', 'Remifentanil', 'propofol']","['BIS value', 'time to respiratory breath recovery and time to extubation, along with bispectral index (BIS) values and hemodynamic status', 'duration of PACU stay', 'adverse events', 'blood pressure and heart rate (HR', 'Visual analog scale and satisfaction scores', 'time to spontaneous breathing recovery, the time to extubation, and the incidence of hypoxemia after extubation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]",99.0,0.115538,"After anesthetic administration, the BIS value decreased less in the Rem group (P<0.0001); blood pressure and heart rate (HR) declined, but were comparable in both groups.
","[{'ForeName': 'Lin-Jia', 'Initials': 'LJ', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Si-Bi', 'Initials': 'SB', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiu-Hong', 'Initials': 'XH', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China. niyan812@njmu.edu.cn.'}]",Annals of palliative medicine,['10.21037/apm-20-1146']
2362,33040562,A randomized controlled trial comparing the efficacy of tigecycline versus meropenem in the treatment of postoperative complicated intra-abdominal infections.,"BACKGROUND


The efficacy and safety of tigecycline in the treatment of complicated intra-abdominal infections (cIAIs) is potentially controversial. Here we conducted the non-inferiority study to assess the efficacy and safety of tigecycline versus meropenem in the treatment of postoperative cIAIs.
METHODS


Data of abdominal tumor surgery patients with postoperative cIAIs admitted to intensive care unit (ICU) between October 2017 and December 2019 were collected. A prospective, randomized controlled trial was conducted in which 56 eligible patients with cIAIs randomly received intravenous tigecycline or meropenem for 3 to 14 days. Patients and clinicians were not blinded to the group allocation.
RESULTS


The total of 56 patients were enrolled, which were divided into 2 groups, one group included 30 patients receiving meropenem and another group included 26 receiving tigecycline therapy. The 2 groups were similar at demographic and baseline clinical characteristics. Microorganisms were isolated from 46 of 56 patients (82.14%), with a total of 107 pathogens were cultured in two groups. The two groups had similar distribution of infecting microorganisms. The primary end point was the clinical response at the end-oftherapy (EOT) visit and upon discharge visit and comprehensive efficacy. The clinical success rates were 83.33%, 76.67% for meropenem versus 76.92%, 88.46% for tigecycline at the EOT visit and upon discharge visit (P>0.05), respectively. Comprehensive efficacy did not significantly differ between two groups either. There were no significant differences in 30-day and 60-day all-cause mortality between two groups (P>0.05). The univariable analysis identified that serum albumin at admission ICU, colorectal cancer on oncology type, postoperative abdominal bleeding were the risk factors for 60-day all-cause mortality. The multivariable analysis showed that postoperative abdominal bleeding were independent predictors of 60-day all-cause mortality. Gastrointestinal disorders and antibacterials-induced Fungal Infection were the most frequently reported adverse events (AEs). The incidence of AEs was similar between meropenem and tigecycline groups (P>0.05).
CONCLUSIONS


Taken together, the study demonstrated that tigecycline is as effective and safe as meropenem for postoperative cIAIs in abdominal tumors patients. Tigecycline is non-inferior to meropenem.",2020,"The incidence of AEs was similar between meropenem and tigecycline groups (P>0.05).
","['postoperative complicated intra-abdominal infections', '56 patients were enrolled, which were divided into 2 groups, one group included 30 patients receiving', 'abdominal tumors patients', '56 eligible patients with cIAIs randomly received', 'Data of abdominal tumor surgery patients with postoperative cIAIs admitted to intensive care unit (ICU) between October 2017 and December 2019 were collected']","['Tigecycline', 'tigecycline', 'tigecycline versus meropenem', 'meropenem', 'intravenous tigecycline or meropenem', 'meropenem and another group included 26 receiving tigecycline therapy']","['clinical success rates', 'incidence of AEs', 'Comprehensive efficacy', 'efficacy and safety', 'serum albumin at admission ICU, colorectal cancer on oncology type, postoperative abdominal bleeding', 'Gastrointestinal disorders and antibacterials-induced Fungal Infection', 'similar distribution of infecting microorganisms', 'postoperative abdominal bleeding', 'clinical response at the end-oftherapy (EOT) visit and upon discharge visit and comprehensive efficacy', '30-day and 60-day all-cause mortality']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C4524048', 'cui_str': 'Complicated intra-abdominal infection'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0000735', 'cui_str': 'Neoplasm of abdomen'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C1260298', 'cui_str': 'tigecycline'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026946', 'cui_str': 'Mycosis'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",56.0,0.0709985,"The incidence of AEs was similar between meropenem and tigecycline groups (P>0.05).
","[{'ForeName': 'Hai-Jun', 'Initials': 'HJ', 'LastName': 'Wang', 'Affiliation': 'Intensive Care Unit, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xue-Zhong', 'Initials': 'XZ', 'LastName': 'Xing', 'Affiliation': 'Intensive Care Unit, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. xingxzh2000@aliyun.com.'}, {'ForeName': 'Shi-Ning', 'Initials': 'SN', 'LastName': 'Qu', 'Affiliation': 'Intensive Care Unit, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chu-Lin', 'Initials': 'CL', 'LastName': 'Huang', 'Affiliation': 'Intensive Care Unit, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Intensive Care Unit, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Intensive Care Unit, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Quan-Hui', 'Initials': 'QH', 'LastName': 'Yang', 'Affiliation': 'Intensive Care Unit, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhen-Nan', 'Initials': 'ZN', 'LastName': 'Yuan', 'Affiliation': 'Intensive Care Unit, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Annals of palliative medicine,['10.21037/apm-20-907']
2363,33040565,Narrative review of palliative hypofractionated radiotherapy for high grade glioma.,"High grade gliomas (HGG) include World Health Organization (WHO) grade III anaplastic astrocytoma (AA) and WHO grade IV glioblastoma (GBM). As genomic alterations are prognostic, even WHO grade II, IDH-wildtype gliomas may be considered as HGG. Current management of HGG include best supportive care (BSC), surgery, radiation therapy (RT), chemotherapy, and a combination. Elderly patients (defined here as age ≥65) with GBM have significantly worse survival compared to younger patients. Similarly, patients with poor performance status [defined as Karnofsky performance status (KPS) <60 or ECOG performance status (PS) >2], regardless of age have worse outcomes. The standard of care for treatment of HGG involves surgery and chemoradiation. However, the optimal treatment in terms of efficacy, safety and maintaining quality of life (QoL), remains a matter of debate in the elderly and/or poor performing patients due to their worse prognosis. Less aggressive interventions are usually reserved for these patients despite surgery providing a survival and neurologic benefit. Improved survival has been noted in elderly patients treated with RT in comparison with those receiving best supportive care (BSC) alone, with similar survival for patients undergoing standard RT (60 Gy/30 fractions) and hypofractionated RT (25-40 Gy in 5-15 daily fractions). An alkylating agent, temozolomide (TMZ), represents a safe and effective option in select patients with promoter methylation of O6-methylguanine-DNA-methyltransferase (MGMT) gene. A recent phase III randomized trial for GBM patients (age ≥65 years, ECOG PS 0-2) demonstrated a significant improvement in progression-free survival (PFS) and overall survival (OS) with hypofractionated RT (40 Gy/15 fractions) with concurrent and adjuvant TMZ vs. RT alone, without adversely impacting either QoL or functional status. Despite chemoradiation becoming the recommended treatment in GBM patients who are elderly but fit, several questions remain unanswered. This includes the survival impact of chemoradiation in patients with severe comorbidities or with ECOG PS >2 or a combination of poor prognostic features such as male gender, poor neurocognition, biopsy only and lack of MGMT methylation. Personalized management of patients with HGG is warranted in the modern era as we attempt to balance the benefit of efficacious treatment with potential toxicity while appreciating the many nuances associated with multiple prognostic factors on anticipated survival. Here, we aim to review the palliative management options available for HGG patients with an emphasis on the role of RT.",2020,"Improved survival has been noted in elderly patients treated with RT in comparison with those receiving best supportive care (BSC) alone, with similar survival for patients undergoing standard RT (60 Gy/30 fractions) and hypofractionated RT (25-40 Gy in 5-15 daily fractions).","['select patients with promoter methylation of O6-methylguanine-DNA-methyltransferase (MGMT) gene', 'high grade glioma', 'GBM patients who are elderly', 'patients with severe comorbidities or with ECOG PS >2 or a combination of poor prognostic features such as male gender, poor neurocognition, biopsy only and lack of MGMT methylation', 'patients with HGG', 'HGG patients with an emphasis on the role of RT', 'elderly patients treated with', 'Elderly patients (defined here as age ≥65) with']","['HGG include best supportive care (BSC), surgery, radiation therapy (RT), chemotherapy, and a combination', 'TMZ vs. RT alone', 'GBM', 'alkylating agent, temozolomide (TMZ', 'palliative hypofractionated radiotherapy', 'RT']","['progression-free survival (PFS) and overall survival (OS', 'High grade gliomas (HGG) include World Health Organization (WHO) grade III anaplastic astrocytoma (AA) and WHO grade IV glioblastoma (GBM', 'efficacy, safety and maintaining quality of life (QoL', 'Karnofsky performance status (KPS) <60 or ECOG performance status', 'survival', 'Improved survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0069197', 'cui_str': 'Methylated-DNA-protein-cysteine methyltransferase'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439796', 'cui_str': 'Biopsy only'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0334579', 'cui_str': 'Astrocytoma, anaplastic'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0387582,"Improved survival has been noted in elderly patients treated with RT in comparison with those receiving best supportive care (BSC) alone, with similar survival for patients undergoing standard RT (60 Gy/30 fractions) and hypofractionated RT (25-40 Gy in 5-15 daily fractions).","[{'ForeName': 'Hina', 'Initials': 'H', 'LastName': 'Saeed', 'Affiliation': 'Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI, USA. hisaeed@mcw.edu.'}, {'ForeName': 'Yolanda D', 'Initials': 'YD', 'LastName': 'Tseng', 'Affiliation': 'Department of Radiation Oncology, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Simon S', 'Initials': 'SS', 'LastName': 'Lo', 'Affiliation': 'Department of Radiation Oncology, University of Washington School of Medicine, Seattle, WA, USA.'}]",Annals of palliative medicine,['10.21037/apm-20-1246']
2364,33040573,EXPRESS: Reflective testing â a randomised controlled trial in primary care patients Running head: reflective testing.,"BACKGROUNDReflective testing i.e. interpreting, commenting on and, if necessary, adding tests in order to aid the diagnostic process in a meaningful and efficient manner, is an extra service provided by laboratory medicine. However, there have been no prospective randomised controlled trials investigating the value of reflective testing in patient management.METHODSIn this trial, primary care patients were randomly allocated to an intervention group where general practitioners received laboratory tests results as requested as well as add-on test results with interpretative comments where considered appropriate by the laboratory specialist, or to a control group where general practitioners only received the laboratory test results requested. Patientsâ medical records were evaluated with a follow-up period of six months. For both groups, the primary outcome measures i.e. both intended action and actual management action, were blindly assessed by an independent expert panel as adequate, neutral or inadequate.RESULTSIn 226 of the 270 cases (84%) reflective testing was considered to be useful for the patient. In the intervention group (n=148), actual management by the general practitioner was scored as adequate (n=104; 70%), neutral (n=29; 20%) or not adequate (n=15; 10%). In the control group (n=122), these numbers were 57 (47%), 37 (30%) and 28 (23%). This difference was statistically significant (p<0.001).CONCLUSIONThis randomised controlled trial showed a positive effect of reflective testing in primary care patients on the adequacy of their management, as documented in medical records.",2020,"This difference was statistically significant (p<0.001).CONCLUSIONThis randomised controlled trial showed a positive effect of reflective testing in primary care patients on the adequacy of their management, as documented in medical records.","['primary care patients', 'primary care patients Running head', '226 of the 270 cases (84']","['intervention group where general practitioners received laboratory tests results as requested as well as add-on test results with interpretative comments where considered appropriate by the laboratory specialist, or to a control group where general practitioners only received the laboratory test results requested']",['intended action and actual management action'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1292787', 'cui_str': 'Management - action'}]",,0.0973084,"This difference was statistically significant (p<0.001).CONCLUSIONThis randomised controlled trial showed a positive effect of reflective testing in primary care patients on the adequacy of their management, as documented in medical records.","[{'ForeName': 'Wytze', 'Initials': 'W', 'LastName': 'Oosterhuis', 'Affiliation': 'Zuyderland Medical Centre Heerlen, Department of Clinical Chemistry and Hematology, Netherlands.'}, {'ForeName': 'Wilhelmine', 'Initials': 'W', 'LastName': 'Verboeket-van de Venne', 'Affiliation': 'Zuyderland Medical Centre Heerlen, Department of Clinical Chemistry and Hematology, Netherlands.'}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'Van Deursen', 'Affiliation': 'Zuyderland Medical Centre Heerlen, Department of Internal Medicine, Netherlands.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Stoffers', 'Affiliation': 'Maastricht University, Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Netherlands.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Van Acker', 'Affiliation': 'Zuyderland Medical Centre Heerlen, Department of Clinical Chemistry and Hematology, Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Bossuyt', 'Affiliation': 'Amsterdam University Medical Centres, Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Netherlands.'}]",Annals of clinical biochemistry,['10.1177/0004563220968373']
2365,33040600,Does miniaturization actually decrease bleeding following Percutaneous Nephrolithotomy? A single center Randomized Trial.,"INTRODUCTION Miniaturization of percutaneous nephrolithotomy (mPCNL) was proposed to decrease postoperative bleeding as there is decreased parenchymal injury compared to standard percutaneous nephrolithotomy (SPCNL). Published randomized controlled trials (RCT) evaluating bleeding following mPCNL have shown conflicting results. Hence, the evidence to say that mPCNL offers less postoperative bleeding is not robust. MATERIALS AND METHODS Prospective RCT was done comparing mPCNL and SPCNL for treatment of renal stones of size 1-3cm. Patients with active urinary tract infection, renal malformation, uncorrected coagulopathy and raised serum creatinine(>1.5mg/dl) were excluded. Blood loss was evaluated by measuring fall in haemoglobin and haematocrit on postoperative day (POD) 1. Post-operative pain was evaluated by visual analogue scale (VAS) score at 6 hours, 24 hours and 48 hours. RESULTS A total of 60 patients (30 in each arm) were enrolled during the study period. All the baseline preoperative variables were comparable in both the groups. SPCNL group had significantly higher drop in haematocrit level as compared to mPCNL (4.6±3.1% vs. 3.1±2.1%, p value=0.02). Mean fall in haemoglobin was higher in SPCNL as compared to mPCNL (1.61±0.9 gm% vs. 1.21±0.7 gm%, p value=0.07) but was not significant. Blood transfusion rate was comparable in both the groups (1 patient in each group). The mPCNL group had significantly less VAS scores at 6 hours (3.27±1.20 vs. 4.40±1.52, p=0.002) and 24 hours (2.10±0.54 vs. 2.83±1.05, p=0.001) following surgery. Postoperative complications and hospital stay were comparable in both the arms. CONCLUSION mPCNL is associated with less post-operative bleeding and pain than SPCNL. However, the small tract size doesn't prevent against the clinically significant bleeding requiring blood transfusion.",2020,"Mean fall in haemoglobin was higher in SPCNL as compared to mPCNL (1.61±0.9 gm% vs. 1.21±0.7 gm%, p value=0.07) but was not significant.","['Patients with active urinary tract infection, renal malformation, uncorrected coagulopathy and raised serum creatinine(>1.5mg/dl) were excluded', 'renal stones of size 1-3cm', '60 patients (30 in each arm) were enrolled during the study period']","['mPCNL and SPCNL', 'percutaneous nephrolithotomy (mPCNL', 'mPCNL', 'standard percutaneous nephrolithotomy (SPCNL']","['postoperative bleeding', 'Postoperative complications and hospital stay', 'VAS scores', 'visual analogue scale (VAS) score', 'haematocrit level', 'Mean fall in haemoglobin', 'Blood loss', 'Blood transfusion rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C4551596', 'cui_str': 'Kidney malformation'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0026164', 'cui_str': 'Miniaturisation'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",60.0,0.0777288,"Mean fall in haemoglobin was higher in SPCNL as compared to mPCNL (1.61±0.9 gm% vs. 1.21±0.7 gm%, p value=0.07) but was not significant.","[{'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Thakur', 'Affiliation': 'PGIMER, 29751, urology, sector 12, chandigarh, Chandigarh, India, 160012; expeditorsupertramp@gmail.com.'}, {'ForeName': 'Aditya P', 'Initials': 'AP', 'LastName': 'Sharma', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, 29751, Urology, PGIMER, Chandigarh, Chandigarh, India, 160012; aditya.p.sharma@gmail.com.'}, {'ForeName': 'Sudheer K', 'Initials': 'SK', 'LastName': 'Devana', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, 29751, Urology, advanced urology centre,26,B Block, 2nd floor, Nehru hospital, sector 12,PGI,, Chandigarh, India, 160012; drsudheer1983@gmail.com.'}, {'ForeName': 'Kalpesh', 'Initials': 'K', 'LastName': 'Parmar', 'Affiliation': 'PGIMER, Urology, Sector 12, Chandigarh, Chandigarh, Outside U.S./Canada, India, N/A.'}, {'ForeName': 'Ravimohan', 'Initials': 'R', 'LastName': 'Mavuduru', 'Affiliation': 'postgraduate institute of medical education and research, UROLOGY, nehru hospital, Chandigarh, Please Select, India, 160012.'}, {'ForeName': 'Girdhar Singh', 'Initials': 'GS', 'LastName': 'Bora', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, 29751, Urology, Advanced Urology Centre , 2nd level ,, B Block , Nehru Hospital, PGIMER , Chandigarh, Chandigarh, India, 160012; girdhar2k@gmail.com.'}, {'ForeName': 'Àrup', 'Initials': 'À', 'LastName': 'Mandal', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, 29751, Urology, Chandigarh, India; drarupkumar@gmail.com.'}]",Journal of endourology,['10.1089/end.2020.0533']
2366,33040610,Can the early use of botulinum toxin in post stroke spasticity reduce contracture development? A randomised controlled trial.,"OBJECTIVE


Does early treatment of spasticity with botulinum-toxin (BoNTA), in (hyper)acute stroke patients without arm-function, reduce contractures and improve function.
DESIGN


Randomised placebo-controlled-trial.
SETTING


Specialised stroke-unit.
PARTICIPANTS & INTERVENTION


Patients with an Action Research Arm Test (ARAT) grasp-score⩽2 who developed spasticity within six-weeks of a first stroke were randomised to receive injections of: 0.9%sodium-chloride solution (placebo) or onabotulinumtoxin-A (treatment).
OUTCOME-MEASURES


Spasticity, contractures, splint use and arm function (ARAT) were taken at baseline, 12-weeks post-injection and six-months after stroke. Additionally, spasticity and contractures were measured at weeks-two, four and six post-injection.
RESULTS


Ninety three patients were randomised. Mean time to intervention was 18-days (standard deviation = 9.3). Spasticity was lower in the treatment group with difference being significant between week-2 to 12 (elbow) and week-2 to 6 (wrist). Mean-difference (MD) varied between -8.5(95% CI -17 to 0) to -9.4(95% CI -14 to -5) µV.Contracture formation was slower in the treatment group. Passive range of motion was higher in the treatment group and was significant at week-12 (elbow MD6.6 (95% CI -0.7 to -12.6)) and week-6 (wrist MD11.8 (95% CI 3.8 to 19.8)). The use of splints was lower in the treatment group odds ratio was 7.2 (95% CI 1.5 to 34.1) and 4.2 (95% CI 1.3 to 14.0) at week-12 and month-6 respectively.Arm-function was not significantly different between the groups MD2.4 (95% CI -5.3 to 10.1) and 2.9 (95% CI -5.8 to 11.6) at week-12 and month-6 respectively.
CONCLUSION


BoNTA reduced spasticity and contractures after stroke and effects lasted for approximately 12-weeks. BoNTA reduced the need for concomitant contracture treatment and did not interfere with recovery of arm function.
TRIAL REGISTRATION


EudraCT (2010-021257-39) and ClinicalTrials.gov-Identifier: NCT01882556.",2020,Passive range of motion was higher in the treatment group and was significant at week-12,"['Specialised stroke-unit', 'Patients with an Action Research Arm Test (ARAT) grasp-score⩽2 who developed spasticity within six-weeks of a first stroke', 'Ninety three patients were randomised']","['botulinum toxin', 'botulinum-toxin (BoNTA', 'placebo', '0.9%sodium-chloride solution (placebo) or onabotulinumtoxin-A (treatment']","['µV.Contracture formation', 'Mean-difference (MD', 'Passive range of motion', 'Mean time', 'Arm-function', 'spasticity and contractures', 'Spasticity, contractures, splint use and arm function (ARAT', 'Spasticity']","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}]",93.0,0.285423,Passive range of motion was higher in the treatment group and was significant at week-12,"[{'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Lindsay', 'Affiliation': 'School of Allied Health Professions, Keele University, Staffordshire, UK.'}, {'ForeName': 'Sissi', 'Initials': 'S', 'LastName': 'Ispoglou', 'Affiliation': 'Department of Elderly Medicine, Sandwell Hospital, West Bromwich, West Midlands, UK.'}, {'ForeName': 'Brinton', 'Initials': 'B', 'LastName': 'Helliwell', 'Affiliation': 'Ulster Hospital, South Eastern HSC Trust, Belfast.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Hicklin', 'Affiliation': 'Department of Elderly Medicine, Sandwell Hospital, West Bromwich, West Midlands, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Sturman', 'Affiliation': 'Neurology Department, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Pandyan', 'Affiliation': 'School of Allied Health Professions, Keele University, Staffordshire, UK.'}]",Clinical rehabilitation,['10.1177/0269215520963855']
2367,33040613,Efficacy of Dapagliflozin on Renal Function and Outcomes in Patients with Heart Failure with Reduced Ejection Fraction: Results of DAPA-HF.,"Background:  Many patients with heart failure and reduced ejection fraction (HFrEF) have chronic kidney disease (CKD) which complicates pharmacological management and is associated with worse outcomes. We assessed the safety and efficacy of dapagliflozin in patients with HFrEF, according to baseline kidney function, in the Dapagliflozin and Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF). We also examined the effect of dapagliflozin on kidney function after randomization. Many patients with heart failure and reduced ejection fraction (HFrEF) have chronic kidney disease (CKD) which complicates pharmacological management and is associated with worse outcomes. We assessed the safety and efficacy of dapagliflozin in patients with HFrEF, according to baseline kidney function, in the Dapagliflozin and Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF). We also examined the effect of dapagliflozin on kidney function after randomization.  Methods:  HFrEF patients with or without type 2 diabetes and an estimated glomerular filtration rate (eGFR) ≥30 ml/min/1.73m 2  were enrolled in DAPA-HF. We calculated the incidence of the primary outcome (CV death or worsening HF) according to eGFR category at baseline (<60 and ≥60 ml/min/1.73m 2 ) as well as using eGFR at baseline as a continuous measure. Secondary cardiovascular outcomes and a pre-specified composite renal outcome (≥ 50% sustained decline eGFR, end stage renal disease (ESRD) or renal death) were also examined, along with decline in eGFR over time.  Results:  Of 4742 with a baseline eGFR, 1926 (41%) had eGFR <60 ml/min/1.73m 2 . The effect of dapagliflozin on the primary and secondary outcomes did not differ by eGFR category or examining eGFR as a continuous measurement. The hazard ratio (95% confidence interval (CI)) for the primary endpoint in patients with CKD was 0.71 (0.59, 0.86) vs. 0.77 (0.64, 0.93) in those with an eGFR ≥60 ml/min/1.73m 2  (interaction p=0.54). The composite renal outcome was not reduced by dapagliflozin (HR=0.71, 95% CI 0.44, 1.16; p=0.17) but the rate of decline in eGFR between day 14 and 720 was less with dapagliflozin, -1.09 (-1.41, -0.78) vs. placebo -2.87 (-3.19, -2.55) ml/min/1.73m 2  per year (p<0.001). This was observed in those with and without type 2 diabetes (p for interaction=0.92)  Conclusions:  Baseline kidney function did not modify the benefits of dapagliflozin on morbidity and mortality in HFrEF and dapagliflozin slowed the rate of decline in eGFR, including in patients without diabetes.  Clinical Trial Registration:  https://clinicaltrials.gov Unique Identifier: NCT03036124.",2020,The effect of dapagliflozin on the primary and secondary outcomes did not differ by eGFR category or examining eGFR as a continuous measurement.,"['≥30', 'Patients with Heart Failure with Reduced Ejection Fraction', 'patients with or without type 2 diabetes and an estimated glomerular filtration rate (eGFR', 'ml/min/1.73m 2  were enrolled in DAPA-HF', 'Many patients with heart failure and reduced ejection fraction (HFrEF) have chronic kidney disease (CKD', 'patients with HFrEF, according to baseline kidney function, in the Dapagliflozin and Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF']","['HFrEF', 'placebo', 'https://clinicaltrials.gov', 'Dapagliflozin', 'dapagliflozin']","['rate of decline in eGFR', 'Renal Function and Outcomes', 'safety and efficacy', 'incidence of the primary outcome (CV death or worsening HF', 'pre-specified composite renal outcome (≥ 50% sustained decline eGFR, end stage renal disease (ESRD) or renal death', 'hazard ratio', 'eGFR over time', 'composite renal outcome', 'kidney function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",,0.182183,The effect of dapagliflozin on the primary and secondary outcomes did not differ by eGFR category or examining eGFR as a continuous measurement.,"[{'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'Department of Cardiology, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Medicine, Saarland University Hospital, Homburg-Saar, Germany.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Chopra', 'Affiliation': 'Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India.'}, {'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'Department of Cardiology, University Medical Center and University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Department of Cardiology, Shanghai Institute of Cardiovascular Disease and Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kitakaze', 'Affiliation': 'Cardiovascular Division of Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Department of Cardiology, Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Gentofte University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Tereshchenko', 'Affiliation': 'Department of Myocardial Disease and Heart Failure, National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Pham Nguyen', 'Initials': 'PN', 'LastName': 'Vinh', 'Affiliation': 'Department of Internal Medicine, Tan Tao University, Tan Duc, Vietnam.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, University of Missouri, Kansas City, MO & The George Institute for Global Health, University of New South Wales, Sydney, Australia.""}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Center for Heart Diseases, University Hospital, Wroclaw Medical University, Poland.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, SWEDEN.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.050391']
2368,33040631,Beneficial Effect of  Lactobacillus plantarum  IS-10506 Supplementation in Adults with Atopic Dermatitis: A Randomized Controlled Trial.,"Introduction:  Although the therapeutic effects of probiotic in atopic dermatitis (AD) are known, the limited findings in adults are inconsistent.  Lactobacillus plantarum  (LP) IS-10506 was found to improve AD symptoms due to its immunomodulatory effects. Objective:  To assess the Scoring Atopic Dermatitis Index (SCORAD), the serum immunoglobulin E (IgE), interleukin (IL)-4, interferon gamma (IFN-γ), forkhead box P3 (Foxp3+), and IL-17 levels in adults with mild and moderate AD after LP IS-10506 supplementation. Methods:  A randomized double-blind placebo-controlled trial comparing the microencapsulated probiotic (2 × 10 10  CFU/day) and placebo (skim milk-Avicel) was conducted at an outpatient clinic on 30 adults with mild and moderate AD. The patients were divided into 2 groups with 15 patients each: intervention and control. Result:  The SCORAD score was significantly lower in the probiotic than placebo group on the 8 th  weeks. The IL-4 and IL-17 levels were significantly lower in the probiotic than placebo group. The IFN-γ and Foxp3+ levels were significantly higher in the probiotic than placebo group. However, the IgE levels remained significantly unchanged. Conclusion:  The administration of LP IS-10506 is effective for alleviating AD symptoms in adults owing to its immunomodulatory effects.",2020,The IFN-γ and Foxp3+ levels were significantly higher in the probiotic than placebo group.,"['adults with mild and moderate AD after LP IS-10506 supplementation', 'Adults with Atopic Dermatitis', '30 adults with mild and moderate AD', 'atopic dermatitis (AD']","['intervention and control', 'Lactobacillus plantarum  (LP) IS-10506', 'Lactobacillus plantarum', 'placebo (skim milk-Avicel', 'microencapsulated probiotic', 'placebo', 'IS-10506 Supplementation', 'LP IS-10506']","['IFN-γ and Foxp3+ levels', 'SCORAD score', 'IL-4 and IL-17 levels', 'Scoring Atopic Dermatitis Index (SCORAD), the serum immunoglobulin E (IgE), interleukin (IL)-4, interferon gamma (IFN-γ), forkhead box P3 (Foxp3+), and IL-17 levels', 'IgE levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0349375', 'cui_str': 'Skim milk'}, {'cui': 'C0733543', 'cui_str': 'Avicel'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0856520', 'cui_str': 'Serum immunoglobulin E'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}]",30.0,0.240079,The IFN-γ and Foxp3+ levels were significantly higher in the probiotic than placebo group.,"[{'ForeName': 'Crs', 'Initials': 'C', 'LastName': 'Prakoeswa', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Universitas Airlangga, Dr. Soetomo Teaching Hospital, Surabaya, Indonesia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bonita', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Universitas Airlangga, Dr. Soetomo Teaching Hospital, Surabaya, Indonesia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karim', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Universitas Airlangga, Dr. Soetomo Teaching Hospital, Surabaya, Indonesia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Herwanto', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Universitas Airlangga, Dr. Soetomo Teaching Hospital, Surabaya, Indonesia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Umborowati', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Universitas Airlangga, Dr. Soetomo Teaching Hospital, Surabaya, Indonesia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Setyaningrum', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Universitas Airlangga, Dr. Soetomo Teaching Hospital, Surabaya, Indonesia.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Hidayati', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Universitas Airlangga, Dr. Soetomo Teaching Hospital, Surabaya, Indonesia.'}, {'ForeName': 'I S', 'Initials': 'IS', 'LastName': 'Surono', 'Affiliation': 'Food Technology Department, Faculty of Engineering, Bina Nusantara University, Jakarta, Indonesia 11480.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1836310']
2369,33050928,"SOURCE: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma.","BACKGROUND


Many patients with severe asthma continue to experience asthma symptoms and exacerbations despite standard-of-care treatment. A substantial proportion of these patients require long-term treatment with oral corticosteroids (OCS), often at high doses, which are associated with considerable multiorgan adverse effects, including metabolic disorders, osteoporosis and adrenal insufficiency. Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin. In the PATHWAY phase 2b study (NCT02054130), tezepelumab significantly reduced exacerbations by up to 71% in adults with severe, uncontrolled asthma. Several ongoing phase 3 trials (SOURCE, NCT03406078; NAVIGATOR, NCT03347279; DESTINATION, NCT03706079) are assessing the efficacy and safety of tezepelumab in patients with severe, uncontrolled asthma. Here, we describe the design and objectives of SOURCE, a phase 3 OCS-sparing study.
METHODS


SOURCE is an ongoing phase 3, multicentre, randomized, double-blind, placebo-controlled study to evaluate the effect of tezepelumab 210 mg administered subcutaneously every 4 weeks on OCS dose reduction in adults with OCS-dependent asthma. The study comprises a 2-week screening and enrolment period, followed by an OCS optimization phase of up to 8 weeks and a 48-week treatment period, which consists of a 4-week induction phase, followed by a 36-week OCS reduction phase and an 8-week maintenance phase. The primary objective is to assess the effect of tezepelumab compared with placebo in reducing the prescribed OCS maintenance dose. The key secondary objective is to assess the effect of tezepelumab on asthma exacerbation rates. Other secondary objectives include the proportion of patients with a reduction in OCS dose (100% or 50% reduction or those receiving < 5 mg) and the effect of tezepelumab on lung function and patient-reported outcomes.
CONCLUSIONS


SOURCE is evaluating the OCS-sparing potential of tezepelumab in patients with OCS-dependent asthma. SOURCE also aims to demonstrate that treatment with tezepelumab in patients with severe asthma is associated with reductions in exacerbation rates and improvements in lung function, asthma control and health-related quality of life, while reducing OCS dose.
TRIAL REGISTRATION


NCT03406078 ( ClinicalTrials.gov ). Registered 23 January 2018. https://clinicaltrials.gov/ct2/show/NCT03406078.",2020,Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin.,"['adults with OCS-dependent asthma', 'patients with OCS-dependent asthma', 'patients with severe, uncontrolled asthma', 'patients with severe asthma', 'adults with oral corticosteroid dependent asthma', 'adults with severe, uncontrolled asthma']","['oral corticosteroids (OCS', 'Tezepelumab', 'placebo', 'tezepelumab']","['efficacy and safety', 'asthma exacerbation rates', 'exacerbation rates and improvements in lung function, asthma control and health-related quality of life', 'proportion of patients with a reduction in OCS dose']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C4550163', 'cui_str': 'tezepelumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.236054,Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin.,"[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'National Jewish Health, Denver, CO, USA. mikewechsler@gmail.com.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Colice', 'Affiliation': 'Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Griffiths', 'Affiliation': 'Translational Science and Experimental Medicine, Research and Early Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Gun', 'Initials': 'G', 'LastName': 'Almqvist', 'Affiliation': 'Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Skärby', 'Affiliation': 'Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Piechowiak', 'Affiliation': 'Development Operations, BioPharmaceuticals R&D, AstraZeneca, Mississauga, ON, Canada.'}, {'ForeName': 'Primal', 'Initials': 'P', 'LastName': 'Kaur', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Bowen', 'Affiliation': 'Biometrics, Late Respiratory & Immunology, BioPharmaceuticals R&D, Gaithersburg, MD, USA.'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Hellqvist', 'Affiliation': 'Biometrics, Late Respiratory & Immunology, BioPharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Mo', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Garcia Gil', 'Affiliation': 'Global Medical Respiratory, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}]",Respiratory research,['10.1186/s12931-020-01503-z']
2370,33050931,Empagliflozin reduced long-term HbA1c variability and cardiovascular death: insights from the EMPA-REG OUTCOME trial.,"BACKGROUND


Glucose variability has been associated with cardiovascular outcomes in type 2 diabetes, however, the interplay between glucose variability, empagliflozin and cardiovascular death has not been explored. In the EMPA-REG OUTCOME trial, empagliflozin reduced the risk of cardiovascular death by 38%. We explore post-hoc the association between HbA1c variability and cardiovascular death, and the potential mediating effects of HbA1c variability on empagliflozin's cardiovascular death reductions.
METHODS


In total, 7,020 patients with type 2 diabetes and established cardiovascular disease received placebo, empagliflozin 10 mg or 25 mg. We defined within-patient HbA1c variability as standard deviation, coefficient of variation and range of HbA1c measurements (%) post-baseline. First, we compared HbA1c variability until week 28 and 52 by Wilcoxon tests. We explored the association between cardiovascular death and HbA1c variability in placebo and pooled empagliflozin arms separately with landmark analyses at week 28 and 52, and additionally with HbA1c variability as a time-dependent co-variate. We used Cox regression models adjusted for baseline risk factors including changes in HbA1c from baseline to week 12, and the interaction term HbA1c variability* treatment.
RESULTS


HbA1c variability was lower with empagliflozin compared to placebo. In all Cox analyses, high HbA1c variability increased the risk for cardiovascular death in both treatment arms with no interaction with treatment: e.g. an increase in HbA1c variability of one unit for the standard deviation at week 28 was associated with a subsequent increased risk of CV death with HRs of 1.97 (95% CI 1.36, 2.84) and 1.53 (1.01, 2.31) in the placebo and empagliflozin groups, separately, interaction p-value 0.3615.
CONCLUSIONS


HbA1c variability was reduced by empagliflozin and high values of HbA1c variability were associated with an increased risk of cardiovascular death. Empagliflozin's reduction in cardiovascular death did not appear to be mediated by reductions in HbA1c variability. ClinicalTrials.gov number, NCT01131676.",2020,"In all Cox analyses, high HbA1c variability increased the risk for cardiovascular death in both treatment arms with no interaction with treatment: e.g. an increase in HbA1c variability of one unit for the standard deviation at week 28 was associated with a subsequent increased risk of CV death with HRs of 1.97 (95% CI 1.36, 2.84) and 1.53 (1.01, 2.31) in the placebo and empagliflozin groups, separately, interaction p-value 0.3615.
","['7,020 patients with type 2 diabetes and established cardiovascular disease received']","['empagliflozin', 'placebo, empagliflozin 10\xa0mg or 25\xa0mg', 'placebo and pooled empagliflozin', 'placebo', 'Empagliflozin']","['HbA1c variability', 'risk of CV death', 'risk of cardiovascular death', 'cardiovascular death and HbA1c variability', 'cardiovascular death', 'long-term HbA1c variability and cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C0337051', 'cui_str': 'Pool'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",7020.0,0.344366,"In all Cox analyses, high HbA1c variability increased the risk for cardiovascular death in both treatment arms with no interaction with treatment: e.g. an increase in HbA1c variability of one unit for the standard deviation at week 28 was associated with a subsequent increased risk of CV death with HRs of 1.97 (95% CI 1.36, 2.84) and 1.53 (1.01, 2.31) in the placebo and empagliflozin groups, separately, interaction p-value 0.3615.
","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ceriello', 'Affiliation': 'IRCCS MultiMedica, Milan, Italy. antonio.ceriello@hotmail.it.'}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kaspers', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Jyothis', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Nicolucci', 'Affiliation': 'Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01147-9']
2371,33050934,"NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma.","BACKGROUND


Patients with severe, uncontrolled asthma have a significant unmet need for new treatments that have broader effects on airway inflammation, and that provide greater improvements in asthma outcomes than currently approved biologics and standard-of-care therapies. Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin. In the PATHWAY phase 2b study (NCT02054130), tezepelumab significantly reduced exacerbations by up to 71% in adults with severe, uncontrolled asthma, irrespective of baseline disease phenotype. This article reports the design and objectives of the pivotal phase 3 NAVIGATOR study.
METHODS


NAVIGATOR (NCT03347279) is an ongoing randomized, double-blind, placebo-controlled trial in adults (18-80 years old) and adolescents (12-17 years old) with severe, uncontrolled asthma, who are receiving treatment with medium- or high-dose inhaled corticosteroids plus at least one additional controller medication with or without oral corticosteroids (N = 1061). The study population includes approximately equal proportions of patients with high (≥ 300 cells/μL) and low (< 300 cells/μL) blood eosinophil counts. The study comprises a 5-6-week screening period, a 52-week treatment period and a 12-week post-treatment follow-up period. All patients will receive their prescribed controller medications without change throughout the study. The primary efficacy endpoint is the annualized asthma exacerbation rate during the 52-week treatment period. Key secondary endpoints include the effect of tezepelumab on lung function, asthma control and health-related quality of life.
DISCUSSION


NAVIGATOR is evaluating the effect of tezepelumab in patients with a broad range of severe asthma phenotypes at baseline, including those with low blood eosinophil counts. The target sample size for NAVIGATOR (N = 1060) was achieved, and it is the largest clinical study of tezepelumab in severe, uncontrolled asthma to date. NAVIGATOR aims to further investigate the effect of tezepelumab on exacerbations and build on observations from the phase 2b PATHWAY study, and to demonstrate further the potential of tezepelumab to provide patients with severe, uncontrolled asthma with improvements in lung function, asthma control and health-related quality of life.
TRIAL REGISTRATION


NCT03347279 (ClinicalTrials.gov). Registered 20 November 2017.",2020,Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin.,"['Patients with severe, uncontrolled asthma', 'patients with high (≥ 300 cells/μL) and low (<\u2009300 cells/μL) blood eosinophil counts', 'patients with severe, uncontrolled asthma with improvements in lung function, asthma control and health-related quality of life', 'adults (18-80\u2009years old) and adolescents (12-17\u2009years old) with severe, uncontrolled asthma, who are receiving treatment with medium- or high-dose inhaled corticosteroids plus at least one additional controller medication with or without oral corticosteroids (N\u2009=\u20091061', 'adults with severe, uncontrolled asthma, irrespective of baseline disease phenotype', 'adults and adolescents with severe, uncontrolled asthma']","['Tezepelumab', 'placebo', 'tezepelumab']","['efficacy and safety', 'annualized asthma exacerbation rate', 'effect of tezepelumab on lung function, asthma control and health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}]","[{'cui': 'C4550163', 'cui_str': 'tezepelumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C4550163', 'cui_str': 'tezepelumab'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.224993,Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Menzies-Gow', 'Affiliation': 'Royal Brompton Hospital, Sydney Street, London, SW3 6NP, UK. A.Menzies-Gow@rbht.nhs.uk.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Colice', 'Affiliation': 'Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Griffiths', 'Affiliation': 'Translational Science and Experimental Medicine, Early Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Gun', 'Initials': 'G', 'LastName': 'Almqvist', 'Affiliation': 'Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Sandhia', 'Initials': 'S', 'LastName': 'Ponnarambil', 'Affiliation': 'Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Primal', 'Initials': 'P', 'LastName': 'Kaur', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Ruberto', 'Affiliation': 'BioPharma Study Management, Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Mississauga, ON, Canada.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Bowen', 'Affiliation': 'Biometrics, Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Hellqvist', 'Affiliation': 'Biometrics, Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Mo', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Garcia Gil', 'Affiliation': 'Global Medical Respiratory, BioPharmaceuticals Medical, AstraZeneca, Barcelona, Spain.'}]",Respiratory research,['10.1186/s12931-020-01526-6']
2372,33050945,The Efficacy of Famotidine in improvement of outcomes in Hospitalized COVID-19 Patients: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


This study aims to investigate the effect of Famotidine on the recovery process of COVID-19 patients.
TRIAL DESIGN


This phase III randomized clinical trial was designed with two parallel arms, placebo-controlled, single-blind, and concealed allocation.
PARTICIPANTS


All COVID-19 patients admitted to Shahid Mohammadi Hospital in Bandar Abbas whose PCR test results are positive for SARS-Cov-2 and sign the written consent of the study are included in the study and immunocompromised patients, end-stage renal disease, moderate renal failure (clearance Creatinine 30 to 50 ml/min) or stage 4 severe chronic kidney disease or need for dialysis (creatinine clearance lesser than 30 ml/min), history of liver disease, hepatitis C infection or alcoholism, Glucose 6 phosphate dehydrogenase deficiency(G6PD), the ratio of Alanine transaminase to Aspartate transaminase 5 times above the normal limit, history or evidence of long QT segment on Electrocardiogram, psoriasis or porphyria, pregnancy, use of oral contraceptives, Dasatinib, Neratinib, Ozanimod, Pazopanib, Rilpivirine, Siponimod and/or Tizanidine and allergies to any study drug are excluded.
INTERVENTION AND COMPARATOR


Intervention group receives standard pharmacotherapy according to the treatment protocols of the National Committee of COVID-19 and oral famotidine 160 mg (Manufactured by Chemidarou Pharmaceutical Company) four times a day until the day of discharge, for a maximum of fourteen days. Comparator group receives standard drug therapy according to the treatment protocols of the National Committee of COVID-19 and placebo in the same dosage.
MAIN OUTCOMES


Patients' temperature, respiration rate, oxygen saturation, lung infiltration, lactate dehydrogenase and complete blood count were measured at the baseline (before the intervention) and on day 14 after the intervention or on the discharge day.
RANDOMISATION


The person who has no role in admitting patients and assigning patients to random codes preparing random sequences using online tools and by permuted block randomization method. Eligibility criteria are monitored by the person responsible for admitting patients. Codes in a random sequence are assigned to patients by the treatment team without knowing that each code is in the intervention or comparator group. Patient codes are then matched to randomly generated sequence information for interventions.
BLINDING (MASKING)


All participants are unaware of which group of this study they are in and after grouping patients in the groups, Patients receive Famotidine in the treatment group and receive a placebo in the control group. The lead researcher, care givers, data collectors, and outcome assessors are aware of the grouping of patients.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


As there is no prior work on this research question, so no assumptions for the sample size calculation could be made. A total of 20 patients participate in this study, which are randomly divided into two groups of 10 as intervention or control groups.
TRIAL STATUS


Version 3 of the protocol was approved by the Deputy of Research and Technology and the ethics committee of Hormozgan University of Medical Sciences on August 2, 2020, with the local code 990245, and the recruitment started on August 17, 2020. recruitment ended on August 31, 2020. Since the recruitment ended earlier than expected (the expected recruitment end date was 21/12/2020), we submitted post recruitment but prior to publication of the results.
TRIAL REGISTRATION


The protocol was registered before starting subject recruitment under the title: The effect of Famotidine on the improvement of patients with COVID-19, IRCT20200509047364N2, at Iranian Registry of clinical trials ( https://www.irct.ir/trial/49657 ) on 17 August 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"The effect of Famotidine on the improvement of patients with COVID-19, IRCT20200509047364N2, at Iranian Registry of clinical trials ( https://www.irct.ir/trial/49657 ) on 17 August 2020.
","['20 patients participate in this study', 'immunocompromised patients, end-stage renal disease, moderate renal failure (clearance Creatinine 30 to 50 ml/min) or stage 4 severe chronic kidney disease or need for dialysis (creatinine clearance lesser than 30 ml/min), history of liver disease, hepatitis C infection or alcoholism, Glucose 6 phosphate dehydrogenase deficiency(G6PD), the ratio of Alanine transaminase to Aspartate transaminase 5 times above the normal limit, history or evidence of long QT segment on Electrocardiogram, psoriasis or porphyria, pregnancy, use of oral contraceptives, Dasatinib, Neratinib, Ozanimod', 'Version 3 of the protocol was approved by the Deputy of Research and Technology and the ethics committee of Hormozgan University of Medical Sciences on August 2, 2020, with the local code 990245, and the recruitment started on August 17, 2020', 'All COVID-19 patients admitted to Shahid Mohammadi Hospital in Bandar Abbas', 'Hospitalized COVID-19 Patients', 'patients with COVID-19, IRCT20200509047364N2, at Iranian Registry of clinical trials ( https://www.irct.ir/trial/49657 ) on 17 August 2020', 'COVID-19 patients']","['COVID-19 and placebo', 'placebo', 'COVID-19 and oral famotidine 160 mg (Manufactured by Chemidarou Pharmaceutical Company', 'Pazopanib, Rilpivirine', 'Famotidine']","['temperature, respiration rate, oxygen saturation, lung infiltration, lactate dehydrogenase and complete blood count']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0455550', 'cui_str': 'H/O: liver disease'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0017757', 'cui_str': 'Glucose-6-phosphate dehydrogenase'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C1291311', 'cui_str': 'Deficiency of dehydrogenase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442816', 'cui_str': 'Normal limits'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0032708', 'cui_str': 'Disorder of porphyrin metabolism'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C2713008', 'cui_str': 'neratinib'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015620', 'cui_str': 'Famotidine'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}]",20.0,0.0960359,"The effect of Famotidine on the improvement of patients with COVID-19, IRCT20200509047364N2, at Iranian Registry of clinical trials ( https://www.irct.ir/trial/49657 ) on 17 August 2020.
","[{'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Samimagham', 'Affiliation': 'Clinical Research Development Center, Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hassani Azad', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Haddad', 'Affiliation': 'Clinical Research Development Center, Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Arabi', 'Affiliation': 'Department of Internal Medicine and Public Health Research Center, Family Medicine Department, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Dariush', 'Initials': 'D', 'LastName': 'Hooshyar', 'Affiliation': 'Student Research Committee, Faculty of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'KazemiJahromi', 'Affiliation': 'Endocrinology and Metabolism Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. mitra.kazemijahromi@gmail.com.'}]",Trials,['10.1186/s13063-020-04773-6']
2373,33051045,Skin toxicity following radiotherapy in patients with breast carcinoma: is anthocyanin supplementation beneficial?,"BACKGROUND


The EU-supported ATHENA project stems from a previous study suggesting that moderate wine consumption reduced the side-effects of radiotherapy (RT) in breast cancer patients, an effect possibly due to non-alcoholic anthocyanin fractions of wine.
OBJECTIVE


To evaluate the role of anthocyanins on RT skin side effects in breast cancer patients.
METHODS


Randomized, controlled, double-blind clinical trial. Patients were assigned to an intensity modulated radiation therapy (IMRT) either for three or five weeks, then randomized to receive three times a day a water-soluble anthocyanin (125 mg)-rich extract of corn cob or a placebo. Supplementation started one week before till the end of RT. Skin characteristics were detected by a standardized, non-invasive Cutometer® dual-MPA580, providing quantitative indices of skin maximal distensibility (R0), elasticity (R2, R5, R7) and viscoelasticity (R6); a Mexameter® MX18 probe evaluated the skin erythema (Er) and melanin (M). Measures were performed before (T0), at the end of RT and of supplementation (T1), and 1, 6 and 12 months after RT (T2-T4). Acute and late skin toxicity were scored according to the RTOG/EORTG scale. Selected biomarkers were measured at T0 and T1.
RESULTS


193 patients previously assigned to 3- or 5-week RT schedules were randomized to either anthocyanin (97) or placebo (96) supplementation. RT induced changes in skin parameters: R0, R2, R5 and R7 decreased, while R6 increased; the changes in R0 and R6 continued in the same direction up to one year, while the others recovered towards basal values; Er and M peaked at T1 and T2, respectively, and returned to basal values at T4. Comparable skin changes were apparent in anthocyanin and placebo groups. A moderate RT-induced increase in total and HDL cholesterol and triglycerides was prevented by anthocyanins.
CONCLUSIONS


Anthocyanin supplementation did not prevent RT-induced local skin toxicity. The supplementation was well tolerated and safe.",2020,"RT induced changes in skin parameters: R0, R2, R5 and R7 decreased, while R6 increased; the changes in R0 and R6 continued in the same direction up to one year, while the others recovered towards basal values; Er and M peaked at T1 and T2, respectively, and returned to basal values at T4.","['patients with breast carcinoma', 'breast cancer patients', '193 patients previously assigned to 3- or 5-week RT schedules']","['anthocyanins', 'water-soluble anthocyanin ', 'radiotherapy (RT', 'anthocyanin', '125\xa0mg)-rich extract of corn cob or a placebo', 'placebo (96) supplementation', 'radiotherapy', 'intensity modulated radiation therapy (IMRT', 'Anthocyanin supplementation']","['skin maximal distensibility (R0), elasticity (R2, R5, R7) and viscoelasticity (R6); a Mexameter® MX18 probe evaluated the skin erythema (Er) and melanin (M', 'skin parameters: R0, R2, R5 and R7', 'Acute and late skin toxicity', 'Skin toxicity', 'RT-induced local skin toxicity', 'tolerated and safe', 'total and HDL cholesterol and triglycerides', 'Skin characteristics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678222', 'cui_str': 'Carcinoma of breast'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C3667867', 'cui_str': 'corn cob extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",193.0,0.139495,"RT induced changes in skin parameters: R0, R2, R5 and R7 decreased, while R6 increased; the changes in R0 and R6 continued in the same direction up to one year, while the others recovered towards basal values; Er and M peaked at T1 and T2, respectively, and returned to basal values at T4.","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bracone', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli, IS, Italy.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'De Curtis', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli, IS, Italy.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Di Castelnuovo', 'Affiliation': 'Mediterranea Cardiocentro, Napoli, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pilu', 'Affiliation': 'Department of Agricultural and Environmental Sciences - Production, Landscape, Agroenergy, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Boccardi', 'Affiliation': 'Radiotherapy Unit, Gemelli Molise Hospital Campobasso, Italy.'}, {'ForeName': 'Savino', 'Initials': 'S', 'LastName': 'Cilla', 'Affiliation': 'Medical Physics Unit, Gemelli Molise Hospital Campobasso, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Macchia', 'Affiliation': 'Radiotherapy Unit, Gemelli Molise Hospital Campobasso, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Deodato', 'Affiliation': 'Radiotherapy Unit, Gemelli Molise Hospital Campobasso, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Costanzo', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli, IS, Italy.'}, {'ForeName': 'Licia', 'Initials': 'L', 'LastName': 'Iacoviello', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli, IS, Italy; Department of Medicine and Surgery, Research Center in Epidemiology and Preventive Medicine (EPIMED), University of Insubria, Varese, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'de Gaetano', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli, IS, Italy.'}, {'ForeName': 'Alessio Giuseppe', 'Initials': 'AG', 'LastName': 'Morganti', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine (DIMES), University of Bologna, Bologna, Italy.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Petroni', 'Affiliation': 'Department of Bioscience, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Tonelli', 'Affiliation': 'Department of Bioscience, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Maria Benedetta', 'Initials': 'MB', 'LastName': 'Donati', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli, IS, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cerletti', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli, IS, Italy. Electronic address: chiara.cerletti@neuromed.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.09.030']
2374,33051072,Preoperative nerve blocks for hip fracture patients: A pilot randomized trial.,"PURPOSE


To determine the: 1) impact of pre-operative femoral nerve block(PreopFNB) on: a) pain; b) opioid use; and c) early post-operative mobilization relative to usual care(CONTROL) and 2) feasibility of a definitive randomized clinical trial(RCT).
METHODS


This pilot RCT, performed in a Canadian tertiary center, compared PreopFNB to CONTROL in 73 participants aged ≥65 years, who a) were ambulatory pre-hip fracture, b) had Mini Mental Status Examination(MMSE) score ≥13 and c) provided consent(direct/proxy). Participants were randomized to PreopFNB or CONTROL using 2 PreopFNB:1 CONTROL(48 PreopFNB:25 CONTROL) allocation. Pain, opioid use and early post-operative mobilization were compared between groups. Inclusion of those with cognitive impairment and PFNB treatment fidelity were also assessed.
RESULTS


The PreopFNB group was slightly older than CONTROL(mean ±SD: 79.9 ± 8.9 versus 76.8 ± 9.0; p = 0.15) with more males(21[42%] versus 5[22%]; p = 0.04). The overall mean MMSE score was ≥24. Mean pain scores were not significantly different between groups at rest(p = 0.17), with activity(p = 0.21) or non-verbal assessment(p = 0.79). Opioid use(oral morphine equivalents) was non-significantly higher and more variable in CONTROL than PreopFNB pre-operatively(Median [25,75 quartiles] 13.1[0,398] versus 7.5[0,125]) and post-operatively(15.0[0,950] versus 10.0[0,260])(p = 0.28). On day 1 post-operative, 40(87%) PFNB and 17(71%) CONTROL participants mobilized(p = 0.10).
CONCLUSION


We found similar reported pain between groups. Although not significant, opioid use was higher and more variable in CONTROL and more PreopFNB patients mobilized day 1 post-operatively. Participants with cognitive impairment were not frequently enrolled. With modification, a definitive RCT is feasible and would inform pain management after hip fracture.",2020,"Mean pain scores were not significantly different between groups at rest(p = 0.17), with activity(p = 0.21) or non-verbal assessment(p = 0.79).","['hip fracture patients', 'Participants with cognitive impairment were not frequently enrolled', '73 participants aged ≥65 years, who a) were ambulatory pre-hip fracture, b) had Mini Mental Status Examination(MMSE']","['Preoperative nerve blocks', 'pre-operative femoral nerve block(PreopFNB', 'PreopFNB']","['Pain, opioid use and early post-operative mobilization', 'overall mean MMSE score', 'Mean pain scores']","[{'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0015808', 'cui_str': 'Structure of femoral nerve'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",73.0,0.143736,"Mean pain scores were not significantly different between groups at rest(p = 0.17), with activity(p = 0.21) or non-verbal assessment(p = 0.79).","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Beaupre', 'Affiliation': 'Department of Physical Therapy, University of Alberta, Edmonton, Canada, T6G 2G3; Department of Surgery, University of Alberta, Edmonton, Canada, T6G 2G3. Electronic address: lauren.beaupre@ualberta.ca.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Menon', 'Affiliation': 'Department of Surgery, University of Alberta, Edmonton, Canada, T6G 2G3. Electronic address: mmenon@ualberta.ca.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Almaazmi', 'Affiliation': 'Department of Surgery, University of Alberta, Edmonton, Canada, T6G 2G3. Electronic address: almaazmi@ualberta.ca.'}, {'ForeName': 'Sung H', 'Initials': 'SH', 'LastName': 'Kang', 'Affiliation': 'Alberta Bone and Joint Health Institute, Edmonton, Canada, T6G 2G3. Electronic address: skang@albertaboneandjoint.com.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Dieleman', 'Affiliation': 'Alberta Health Services, 112 St and 84 Ave, Edmonton, Canada, T6G 2G4. Electronic address: SDielema@ab.bluecross.ca.'}, {'ForeName': 'Ban', 'Initials': 'B', 'LastName': 'Tsui', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Alberta, Edmonton, Canada, T6G 2G3. Electronic address: bantsui@stanford.edu.'}]",Injury,['10.1016/j.injury.2020.10.029']
2375,33051129,Mini-percutaneous cystolithotripsy (mPCCL) versus transurethral cystolithotripsy (TUC) in pre-school children: Prospective comparative non-randomized outcomes over 8 years.,"INTRODUCTION


Bladder stones in children can often be challenging to manage. We present our experience of minimally invasive percutaneous cystolithotripsy using 'mini-perc' instruments in the treatment of the bladder stones in pre-school children. The study also compares the outcomes of mini-percutaneous cystolithotripsy (mPCCL) and transurethral cystolithotripsy (TUC).
OBJECTIVE


We hypothesized that mPCCL is a new minimally invasive technique with comparable outcomes to TUC.
STUDY DESIGN


After parental consent and institutional review board approval, consecutive pre-school children with bladder stones were included from January 2011-December 2018. We shifted from the TUC to mPCCL in 2014, with mPCCL introduced as a new technique. Outcomes including stone free rate (SFR) and complication rates were compared for patients aged between 1 and 5 years of age who underwent mPCCL or TUC.
RESULTS


A total of 31 patients (16 patients in Group 1 (mPCCL) and 15 patients in Group 2 (TUC) underwent the procedure. The mean age, stone size and operative times were 2.4 ± 0.96 years and 3.8 ± 0.77 years; 1.86 ± 0.65 cm and 1.34 ± 0.52 cm; and 33.5 ± 8.42 min and 38.2 ± 6.76 min for groups 1 and 2 respectively. While there were no intra or post-operative complications in group 1, in group 2 one patient required conversion to mPCCL due to difficulty in fragment removal per urethra and one with residual fragment needed repeat cystoscopy and fragment removal (Clavien IIIb). All patients in both groups were discharged the following day after catheter removal and remained stone free at 1- and 6-month follow-up.
DISCUSSION


Our study shows good outcomes in managing bladder stones with the use of both TUC and mPCCL. We shifted from the former to mPCCL in 2014 during which there was an overlap of both these techniques, while mPCCL was being introduced. Subsequently, all stones have been managed with mPCCL without the need to revert back to TUC. In Group 1, we performed mPCCL, where the puncture was performed under ultrasound-guidance and fragment retrieval was accomplished with the vacuum-cleaner effect through the operating sheath. Complete stone clearance was achieved in all cases with no complications or need for secondary procedures. Limitations of our study include small sample size, single-centre experience, and lack of randomization. Further prospective randomized multicenter studies may be required to validate our results.
CONCLUSION


The technique of percutaneous suprapubic cystolithotripsy using mini-nephroscope is an alternate to transurethral cystolithotripsy. While both these techniques are suitable for smaller bladder stones, PCCL may be considered as the preferred management option of especially large bladder calculus in preschool children.",2020,"Outcomes including stone free rate (SFR) and complication rates were compared for patients aged between 1 and 5 years of age who underwent mPCCL or TUC.
","['were 2.4\xa0±\xa00.96 years and 3.8\xa0±\xa00.77 years; 1.86\xa0±\xa00.65\xa0cm and 1.34\xa0±', 'pre-school children', 'school children with bladder stones were included from January 2011-December 2018', 'preschool children', '31 patients (16 patients in Group 1 (mPCCL) and 15 patients in Group 2 (TUC) underwent the procedure']","['Mini-percutaneous cystolithotripsy (mPCCL) versus transurethral cystolithotripsy (TUC', 'mPCCL', 'percutaneous suprapubic cystolithotripsy using mini-nephroscope', ""minimally invasive percutaneous cystolithotripsy using 'mini-perc' instruments"", 'mini-percutaneous cystolithotripsy (mPCCL) and transurethral cystolithotripsy (TUC', 'TUC and mPCCL']","['no intra or post-operative complications', 'stone free', 'stone free rate (SFR) and complication rates', 'mean age, stone size and operative times', 'Complete stone clearance']","[{'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517479', 'cui_str': '0.77'}, {'cui': 'C4517471', 'cui_str': '0.65'}, {'cui': 'C4517501', 'cui_str': '1.34'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0005683', 'cui_str': 'Urinary bladder stone'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0205498', 'cui_str': 'Suprapubic approach'}, {'cui': 'C0181996', 'cui_str': 'Nephroscope'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",31.0,0.036774,"Outcomes including stone free rate (SFR) and complication rates were compared for patients aged between 1 and 5 years of age who underwent mPCCL or TUC.
","[{'ForeName': 'Dilip Kumar', 'Initials': 'DK', 'LastName': 'Mishra', 'Affiliation': 'Department of Urology, Global Rainbow Hospital, Agra, India. Electronic address: docdilipmishra@yahoo.co.in.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Bhatt', 'Affiliation': 'Department of Pediatrics, F H Medical College, Agra, India. Electronic address: soniabhatt19@gmail.com.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mukhilesh', 'Affiliation': 'Department of Urology, Global Rainbow Hospital, Agra, India. Electronic address: surgeonmukhil@gmail.com.'}, {'ForeName': 'Bhaskar Kumar', 'Initials': 'BK', 'LastName': 'Somani', 'Affiliation': 'Department of Urology University Hospital Southampton NHS Trust, Southampton, UK. Electronic address: b.k.somani@soton.ac.uk.'}, {'ForeName': 'Madhu Sudan', 'Initials': 'MS', 'LastName': 'Agrawal', 'Affiliation': 'Department of Urology, Global Rainbow Hospital, Agra, India. Electronic address: dr.madhu.agra@gmail.com.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.09.021']
2376,33051212,Targeting rehabilitation to improve outcomes after total knee arthroplasty in patients at risk of poor outcomes: randomised controlled trial.,"OBJECTIVE


To evaluate whether a progressive course of outpatient physiotherapy offers superior outcomes to a single physiotherapy review and home exercise based intervention when targeted at patients with a predicted poor outcome after total knee arthroplasty.
DESIGN


Parallel group randomised controlled trial.
SETTING


13 secondary and tertiary care centres in the UK providing postoperative physiotherapy.
PARTICIPANTS


334 participants with knee osteoarthritis who were defined as at risk of a poor outcome after total knee arthroplasty, based on the Oxford knee score, at six weeks postoperatively. 163 were allocated to therapist led outpatient rehabilitation and 171 to a home exercise based protocol.
INTERVENTIONS


All participants were reviewed by a physiotherapist and commenced 18 sessions of rehabilitation over six weeks, either as therapist led outpatient rehabilitation (progressive goal oriented functional rehabilitation protocol, modified weekly in one-one contact sessions) or as physiotherapy review followed by a home exercise based regimen (without progressive input from a physiotherapist).
MAIN OUTCOME MEASURES


Primary outcome was Oxford knee score at 52 weeks, with a 4 point difference between groups considered to be clinically meaningful. Secondary outcomes included additional patient reported outcome measures of pain and function at 14, 26, and 52 weeks post-surgery.
RESULTS


334 patients were randomised. Eight were lost to follow-up. Intervention compliance was more than 85%. The between group difference in Oxford knee score at 52 weeks was 1.91 (95% confidence interval -0.18 to 3.99) points, favouring the outpatient rehabilitation arm (P=0.07). When all time point data were analysed, the between group difference in Oxford knee score was a non-clinically meaningful 2.25 points (0.61 to 3.90, P=0.01). No between group differences were found for secondary outcomes of average pain (0.25 points, -0.78 to 0.28, P=0.36) or worst pain (0.22 points, -0.71 to 0.41, P=0.50) at 52 weeks or earlier time points, or of satisfaction with outcome (odds ratio 1.07, 95% confidence interval 0.71 to 1.62, P=0.75) or post-intervention function (4.64 seconds, 95% confidence interval -14.25 to 4.96, P=0.34).
CONCLUSIONS


Outpatient therapist led rehabilitation was not superior to a single physiotherapist review and home exercise based regimen in patients at risk of poor outcomes after total knee arthroplasty. No clinically relevant differences were observed across primary or secondary outcome measures.
TRIALS REGISTRATION


Current Controlled Trials ISRCTN23357609 and ClinicalTrials.gov NCT01849445.",2020,The between group difference in Oxford knee score at 52 weeks was 1.91,"['patients at risk of poor outcomes after total knee arthroplasty', '334 participants with knee osteoarthritis who were defined as at risk of a poor outcome after total knee arthroplasty, based on the Oxford knee score, at six weeks postoperatively', '13 secondary and tertiary care centres in the UK providing postoperative physiotherapy', '334 patients were randomised', 'patients with a predicted poor outcome after total knee arthroplasty', 'patients at risk of poor outcomes']","['therapist led outpatient rehabilitation and 171 to a home exercise based protocol', 'therapist led outpatient rehabilitation (progressive goal oriented functional rehabilitation protocol, modified weekly in one-one contact sessions) or as physiotherapy review followed by a home exercise based regimen (without progressive input from a physiotherapist']","['Oxford knee score', 'worst pain', 'Intervention compliance', 'pain and function', 'average pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0454532', 'cui_str': 'Functional rehabilitation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",334.0,0.151286,The between group difference in Oxford knee score at 52 weeks was 1.91,"[{'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Hamilton', 'Affiliation': 'Department of Orthopaedics and Trauma, University of Edinburgh, Edinburgh EH16 4SB, UK d.f.hamilton@ed.ac.uk.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Beard', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Barker', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Macfarlane', 'Affiliation': 'Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology) Group, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Tuck', 'Affiliation': 'Usher Institute of Population Health, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Stoddart', 'Affiliation': 'Usher Institute of Population Health, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Wilton', 'Affiliation': 'Department of Orthopaedics, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Hutchinson', 'Affiliation': 'Department of Orthopaedic Surgery, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Gordon D', 'Initials': 'GD', 'LastName': 'Murray', 'Affiliation': 'Usher Institute of Population Health, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'A Hamish R W', 'Initials': 'AHRW', 'LastName': 'Simpson', 'Affiliation': 'Department of Orthopaedics and Trauma, University of Edinburgh, Edinburgh EH16 4SB, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.m3576']
2377,33051276,Planning for success: overcoming challenges to recruitment and conduct of an open-label emergency department-led paediatric trial.,"BACKGROUND


Key challenges to the successful conduct of The Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children (EcLiPSE) trial were identified at the pre-trial stage. These included practitioner anxieties about conducting research without prior consent (RWPC), inexperience in conducting an ED-led trial and use of a medication that was not usual ED practice. As part of an embedded study, we explored parent and practitioner experiences of recruitment, RWPC and conduct of the trial to inform the design and conduct of future ED-led trials.
METHODS


A mixed-methods study within a trial involving (1) questionnaires and interviews with parents of randomised children, (2) interviews and focus groups with EcLiPSE practitioners and (3) audio-recorded trial discussions. We analysed data using thematic analysis and descriptive statistics as appropriate.
RESULTS


A total of 143 parents (93 mothers, 39 fathers, 11 missing information) of randomised children completed a questionnaire and 30 (25 mothers, 5 fathers) were interviewed. We analysed 76 recorded trial recruitment discussions. Ten practitioners (4 medical, 6 nursing) were interviewed, 36 (16 medical, 20 nursing) participated in one of six focus groups. Challenges to the success of the trial were addressed by having a clinically relevant research question, pragmatic trial design, parent and practitioner support for EcLiPSE recruitment and research without prior consent processes, and practitioner motivation and strong leadership. Lack of leadership negatively affected practitioner engagement and recruitment. EcLiPSE completed on time, achieving its required sample size target.
CONCLUSIONS


Successful trial recruitment and conduct in a challenging ED-led trial was driven by trial design, recruitment experience, teamwork and leadership. Our study provides valuable insight from parents and practitioners to inform the design and conduct of future trials in this setting.",2020,"A total of 143 parents (93 mothers, 39 fathers, 11 missing information) of randomised children completed a questionnaire and 30 (25 mothers, 5 fathers) were interviewed.","['Status Epilepticus in children (EcLiPSE', '143 parents (93 mothers, 39 fathers, 11 missing information) of randomised children completed a questionnaire and 30 (25 mothers, 5 fathers', 'Ten practitioners (4 medical, 6 nursing) were interviewed, 36 (16 medical, 20 nursing) participated in one of six focus groups']","['Levetiracetam or Phenytoin', 'EcLiPSE', 'EcLiPSE practitioners and (3) audio-recorded trial discussions']","['time, achieving its required sample size target']","[{'cui': 'C0038220', 'cui_str': 'Status epilepticus'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013969', 'cui_str': 'Emergency treatment'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C0013969', 'cui_str': 'Emergency treatment'}, {'cui': 'C0038220', 'cui_str': 'Status epilepticus'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}]",143.0,0.301124,"A total of 143 parents (93 mothers, 39 fathers, 11 missing information) of randomised children completed a questionnaire and 30 (25 mothers, 5 fathers) were interviewed.","[{'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Roper', 'Affiliation': 'Institute of Population Health & Society, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Lyttle', 'Affiliation': ""Emergency Department, Bristol Royal Children's Hospital, Bristol, UK.""}, {'ForeName': 'Carrol', 'Initials': 'C', 'LastName': 'Gamble', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Humphreys', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Shrouk', 'Initials': 'S', 'LastName': 'Messahel', 'Affiliation': ""Emergency Department, Alder Hey Children's NHS Foundation Trust, Liverpool, Merseyside, UK.""}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Lee', 'Affiliation': ""Emergency Department, Alder Hey Children's NHS Foundation Trust, Liverpool, Merseyside, UK.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Noblet', 'Affiliation': ""Emergency Department, Alder Hey Children's NHS Foundation Trust, Liverpool, Merseyside, UK.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hickey', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Rainford', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Iyer', 'Affiliation': ""Department of Neurology, Alder Hey Children's NHS Foundation Trust, Liverpool, Merseyside, UK.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Appleton', 'Affiliation': ""Department of Neurology, Alder Hey Children's NHS Foundation Trust, Liverpool, Merseyside, UK.""}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Woolfall', 'Affiliation': 'Institute of Population Health & Society, University of Liverpool, Liverpool, UK k.woolfall@liverpool.ac.uk.'}]",Emergency medicine journal : EMJ,['10.1136/emermed-2020-209487']
2378,33051309,Findings and lessons learnt from early termination of a pragmatic comparative effectiveness trial of video consultations in home-based palliative care.,"BACKGROUND


Health systems need evidence about how best to deliver home-based palliative care (HBPC) to meet the growing needs of seriously ill patients. We hypothesised that a tech-supported model that aimed to promote timely inter-professional team coordination using video consultation with a remote physician while a nurse is in the patient's home would be non-inferior compared with a standard model that includes routine home visits by nurses and physicians.
METHODS


We conducted a pragmatic, cluster randomised non-inferiority trial across 14 sites (HomePal Study). Registered nurses (n=111) were randomised to the two models so that approximately half of the patients with any serious illness admitted to HBPC and their caregivers were enrolled in each study arm. Process measures (video and home visits and satisfaction) were tracked. The primary outcomes for patients and caregivers were symptom burden and caregiving preparedness at 1-2 months.
RESULTS


The study was stopped early after 12 months of enrolment (patients=3533; caregivers=463) due to a combination of low video visit uptake (31%), limited substitution of video for home visits, and the health system's decision to expand telehealth use in response to changes in telehealth payment policies, the latter of which was incompatible with the randomised design. Implementation barriers included persistent workforce shortages and inadequate systems that contributed to scheduling and coordination challenges and unreliable technology and connectivity.
CONCLUSIONS


We encountered multiple challenges to feasibility, relevance and value of conducting large, multiyear pragmatic randomised trials with seriously ill patients in the real-world settings where care delivery, regulatory and payment policies are constantly shifting.",2020,Registered nurses (n=111) were randomised to the two models so that approximately half of the patients with any serious illness admitted to HBPC and their caregivers were enrolled in each study arm.,"['home-based palliative care', 'Registered nurses (n=111', 'patients with any serious illness admitted to HBPC and their caregivers were enrolled in each study arm']",['video consultations'],"['Process measures (video and home visits and satisfaction', 'symptom burden and caregiving preparedness']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0086850', 'cui_str': 'Process Measures'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}]",111.0,0.164865,Registered nurses (n=111) were randomised to the two models so that approximately half of the patients with any serious illness admitted to HBPC and their caregivers were enrolled in each study arm.,"[{'ForeName': 'Huong Q', 'Initials': 'HQ', 'LastName': 'Nguyen', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California, USA huong.q2.nguyen@kp.org.'}, {'ForeName': 'Carmit', 'Initials': 'C', 'LastName': 'McMullen', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest Region, Portland, Oregon, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Haupt', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Wang', 'Affiliation': 'Kaiser Permanente Southern California, West Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Werch', 'Affiliation': 'Member-Caregiver Stakeholder Advisory Committee, Kaiser Permanente Northwest, Portland, Oregon, USA.'}, {'ForeName': 'Paula E', 'Initials': 'PE', 'LastName': 'Edwards', 'Affiliation': 'Hospice and Palliative Care Operations, Kaiser Permanente Northwest, Portland, Oregon, USA.'}, {'ForeName': 'Gina M', 'Initials': 'GM', 'LastName': 'Andres', 'Affiliation': 'Regional Home Care Operations, Kaiser Permanente Southern California, Pasadena, California, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Reinke', 'Affiliation': 'VA Puget Sound Health Care System Seattle Division, Seattle, Washington, USA.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Mittman', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California, USA.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Shen', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Mularski', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest Region, Portland, Oregon, USA.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2020-002553']
2379,33051340,Pembrolizumab with or without radiation therapy for metastatic non-small cell lung cancer: a randomized phase I/II trial.,"BACKGROUND


In this phase I/II trial, we evaluated the safety and effectiveness of pembrolizumab, with or without concurrent radiotherapy (RT), for lung and liver lesions from metastatic non-small cell lung cancer (mNSCLC).
METHODS


Patients with lung or liver lesions amenable to RT plus at least one additional non-contiguous lesion were included regardless of programmed death-ligand 1 (PD-L1) status. Pembrolizumab was given at 200 mg every 3 weeks for up to 32 cycles with or without concurrent RT. Metastatic lesions were treated with stereotactic body RT (SBRT; 50 Gy in 4 fractions) if clinically feasible or with traditionally fractionated RT (45 Gy in 15 fractions) if not. The primary end point was the best out-of-field lesion response, and a key secondary end point was progression-free survival (PFS).
RESULTS


The median follow-up time was 20.4 months. One hundred patients (20 phase I, 80 phase II) were evaluable for toxicity, and 72 phase II patients were evaluable for treatment response. No patients in the phase I group experienced grade 4-5 events; in the phase II group, two had grade 4 events and nine had grade 3 events. The ORR in the combined-modality cohort (irrespective of RT schema) was 22%, vs 25% in the pembrolizumab group (irrespective of receipt of salvage RT) (p=0.99). In the concurrent pembrolizumab+RT groups, the out-of-field ORRs were 38% in the pembrolizumab+SBRT group and 10% in the pembrolizumab+traditional RT group. When examining the pembrolizumab-alone patients, the out-of-field ORRs were 33% in those designated to receive salvage SBRT (if required) and 17% for salvage traditional RT. In all patients, the median PFS for pembrolizumab alone was 5.1 months (95% CI 3.4 to 12.7 months), and pembrolizumab/RT (regardless of schema) was 9.1 months (95% CI 3.6 to 18.4 months) (p=0.52). An exploratory analysis revealed that for patients with low PD-L1 expression, the median PFS was 4.6 vs 20.8 months for pembrolizumab with and without RT, respectively (p=0.004).
CONCLUSIONS


Concurrent immunoradiotherapy for mNSCLC is safe, although larger trials are required to address which patients benefit most from RT.
TRIAL REGISTRATION NUMBER


NCT02444741.",2020,"In all patients, the median PFS for pembrolizumab alone was 5.1 months (95% CI 3.4 to 12.7 months), and pembrolizumab/RT (regardless of schema) was 9.1 months (95% CI 3.6 to 18.4 months) (p=0.52).","['Metastatic lesions', 'metastatic non-small cell lung cancer', 'One hundred patients (20 phase', 'lung and liver lesions from metastatic non-small cell lung cancer (mNSCLC', 'Patients with lung or liver lesions amenable to RT plus at least one additional non-contiguous lesion were included regardless of programmed death-ligand 1 (PD-L1) status']","['stereotactic body RT (SBRT', 'Pembrolizumab with or without radiation therapy', 'pembrolizumab', 'pembrolizumab+RT', 'pembrolizumab+traditional RT', 'salvage RT', 'Pembrolizumab', 'pembrolizumab, with or without concurrent radiotherapy (RT', 'pembrolizumab+SBRT']","['best out-of-field lesion response', 'ORR', 'toxicity', 'grade 4-5 events', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0577053', 'cui_str': 'Lesion of liver'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205283', 'cui_str': 'Contiguous'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0540634,"In all patients, the median PFS for pembrolizumab alone was 5.1 months (95% CI 3.4 to 12.7 months), and pembrolizumab/RT (regardless of schema) was 9.1 months (95% CI 3.6 to 18.4 months) (p=0.52).","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Welsh', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States JWelsh@mdanderson.org.'}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Menon', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Verma', 'Affiliation': 'Radiation Oncology, Allegheny General Hospital, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Altan', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Hess', 'Affiliation': 'Department of Biostatistics, MD Anderson Cancer Center, Houston, United States.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'de Groot', 'Affiliation': 'Division of Diagnostic Imaging, Department of Diagnostic Radiology, The University of Texas M.D. Anderson Cancer Center, Houston, United States.'}, {'ForeName': 'Quynh-Nhu', 'Initials': 'QN', 'LastName': 'Nguyen', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'Rejani', 'Initials': 'R', 'LastName': 'Varghese', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'Nathan I', 'Initials': 'NI', 'LastName': 'Comeaux', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Simon', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'Ferdinandos', 'Initials': 'F', 'LastName': 'Skoulidis', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Joe Y', 'Initials': 'JY', 'LastName': 'Chang', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Papdimitrakopoulou', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Lin', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Heymach', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-001001']
2380,33051342,"Novel, non-invasive imaging approach to identify patients with advanced non-small cell lung cancer at risk of hyperprogressive disease with immune checkpoint blockade.","PURPOSE


Hyperprogression is an atypical response pattern to immune checkpoint inhibition that has been described within non-small cell lung cancer (NSCLC). The paradoxical acceleration of tumor growth after immunotherapy has been associated with significantly shortened survival, and currently, there are no clinically validated biomarkers to identify patients at risk of hyperprogression.
EXPERIMENTAL DESIGN


A total of 109 patients with advanced NSCLC who underwent monotherapy with Programmed cell death protein-1 (PD1)/Programmed death-ligand-1 (PD-L1) inhibitors were included in the study. Using RECIST measurements, we divided the patients into responders (n=50) (complete/partial response or stable disease) and non-responders (n=59) (progressive disease). Tumor growth kinetics were used to further identify hyperprogressors (HPs, n=19) among non-responders. Patients were randomized into a training set (D 1 =30) and a test set (D 2 =79) with the essential caveat that HPs were evenly distributed among the two sets. A total of 198 radiomic textural patterns from within and around the target nodules and features relating to tortuosity of the nodule associated vasculature were extracted from the pretreatment CT scans.
RESULTS


The random forest classifier using the top features associated with hyperprogression was able to distinguish between HP and other radiographical response patterns with an area under receiver operating curve of 0.85±0.06 in the training set (D 1 =30) and 0.96 in the validation set (D 2 =79). These features included one peritumoral texture feature from 5 to 10 mm outside the tumor and two nodule vessel-related tortuosity features. Kaplan-Meier survival curves showed a clear stratification between classifier predicted HPs versus non-HPs for overall survival (D 2 : HR=2.66, 95% CI 1.27 to 5.55; p=0.009).
CONCLUSIONS


Our study suggests that image-based radiomics markers extracted from baseline CTs of advanced NSCLC treated with PD-1/PD-L1 inhibitors may help identify patients at risk of hyperprogressions.",2020,"Kaplan-Meier survival curves showed a clear stratification between classifier predicted HPs versus non-HPs for overall survival (D 2 : HR=2.66, 95% CI 1.27 to 5.55; p=0.009).
","['109 patients with advanced NSCLC who underwent monotherapy with Programmed cell death protein-1 (PD1)/Programmed death-ligand-1 (PD-L1) inhibitors were included in the study', 'patients with advanced non-small cell lung cancer at risk of hyperprogressive disease with immune checkpoint blockade', 'patients into responders (n=50) (complete/partial response or stable disease) and non-responders (n=59) (progressive disease']",['PD-1/PD-L1 inhibitors'],['overall survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0135710', 'cui_str': 'PDCD1 protein, human'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",109.0,0.0755434,"Kaplan-Meier survival curves showed a clear stratification between classifier predicted HPs versus non-HPs for overall survival (D 2 : HR=2.66, 95% CI 1.27 to 5.55; p=0.009).
","[{'ForeName': 'Pranjal', 'Initials': 'P', 'LastName': 'Vaidya', 'Affiliation': 'Biomedical Engineering, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Kaustav', 'Initials': 'K', 'LastName': 'Bera', 'Affiliation': 'Biomedical Engineering, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Pradnya D', 'Initials': 'PD', 'LastName': 'Patil', 'Affiliation': 'Hematology and Medical Oncology, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Radiology, University Hospitals of Cleveland, Cleveland, Ohio, USA.'}, {'ForeName': 'Prantesh', 'Initials': 'P', 'LastName': 'Jain', 'Affiliation': 'Department of Radiology, University Hospitals of Cleveland, Cleveland, Ohio, USA.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Alilou', 'Affiliation': 'Biomedical Engineering, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Mohammadhadi', 'Initials': 'M', 'LastName': 'Khorrami', 'Affiliation': 'Biomedical Engineering, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Vamsidhar', 'Initials': 'V', 'LastName': 'Velcheti', 'Affiliation': 'Medical Oncology, NYU Langone Health, New York, New York, USA.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Madabhushi', 'Affiliation': 'Biomedical Engineering, Case Western Reserve University, Cleveland, Ohio, USA axm788@case.edu.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-001343']
2381,33051423,Effect of different perfusion flow on carotid artery blood flow during cardiopulmonary bypass.,"OBJECTIVES


To investigate the effect of cardiopulmonary bypass (CPB) with different perfusion flow on carotid artery blood by using the carotid artery ultrasound.
METHODS


Forty-five adult patients during Dec. 2014 to Jan. 2015 scheduled for heart valve replacement or ventricular septal defect repair were randomly divided into 3 groups ( n =15) according to different perfusion flow during CPB: A Group 1 [(62±2) mL/(kg·min)], a Group 2 [(72±2) mL/(kg·min)], and a Group 3 [(82±2) mL/(kg·min)]. The diameter of the common carotid artery (CCAD), the peak velocity of the common carotid artery (CCAV),the flow of the common carotid artery (CCAF), the diameter of the internal carotid artery (ICAD), the peak velocity of the internal carotid artery (ICAV) and the flow of the internal carotid artery (ICAF) were measured at the responding time points before the anesthesia induction (T1), after the anesthesia induction (T2), 10 min into CPB (T3), 20 min into CPB (T4), 40 min into CPB (T5), 60 min into CPB(T6), 20 min after CPB ending (T7) by doppler ultrasonography, respectively. The hemoglobin (Hb) and lactic acid were compared at the time before CPB(P1),the time when temperature was decreased to the lowest during CPB (P2), the time when temperature was reheated to 35 ℃ (P3), 20 min after CPB was ended (P4), 2 hours after CPB was ended (P5) by α-steady method. The parameters of CPB and hemodynamic parameters at each time point and postoperative condition were recorded.
RESULTS


There was no significant difference in Hb and lactic acid between the three groups (all  P >0.05). For intra-group comparison, the Hb concentration at P2-P5 was lower than that at P1 (all  P <0.05), and the Hb concentration was the lowest at P2 and P3. The level of lactic acid at P3-P5 was higher than those at P1 (all  P <0.05).There were no significant differences in measurement of carotid artery between the left and right sides of the patients at T1 (all  P >0.05). There was no significant difference in CCAV and CCAF among the 3 groups (both  P >0.05). For intra-group comparison, the CCAV at T2-T6 was significantly lower than that at T1 ( P <0.05), and higher at T7 than that at T2-T6 (all  P <0.05), but it was still significantly lower than that at T1 ( P <0.05). The difference of CCAF between T2-T5 and T1 was significant (all  P <0.05). ICAV of G1 was lower than G3 at T3 ( P <0.05). ICAV of G1 was lower than G2, and G2 was lower that G3 at T4 (both  P <0.05). ICAV of G1 was lower than G2 at T6 ( P <0.05). For intra-group comparison, the ICAV at T2 was significantly lower than that at T1 ( P <0.05), and that at T3-T6 was significantly lower than that at T1 and T2 (all  P <0.05). At T3-T6, ICAF of G1 was lower than that of G3 (all  P <0.05). For intra-group comparison, ICAF at T2-T6 was significantly lower than that at T1 (all  P <0.05). At T4, perfusion flow was positively correlated with CCAF, ICAV and ICAV (all  P <0.05). None of the patients had obvious motor, sensory, or consciousness disturbance, and no neurological complications.There was no significant difference in postoperative hospital stay, postoperative ICU time, and postoperative extubation time among the 3 groups (all  P >0.05).
CONCLUSIONS


Different perfusion flows of CPB have different effects on carotids hemodynamics.There is correlation between carotids hemodynamics and perfusion flow. Carotid ultrasound examination can be used to evaluate cardiac output.",2020,"There was no significant difference in postoperative hospital stay, postoperative ICU time, and postoperative extubation time among the 3 groups (all  P >0.05).
","['cardiopulmonary bypass', 'Forty-five adult patients during Dec. 2014 to Jan. 2015 scheduled for heart valve replacement or ventricular septal defect repair']","['perfusion flow during CPB', 'cardiopulmonary bypass (CPB', 'mL/(kg·min', 'perfusion flow']","['CCAF, ICAV and ICAV', 'Hb concentration at P2-P5', 'postoperative hospital stay, postoperative ICU time, and postoperative extubation time', 'CCAV and CCAF', 'carotid artery blood flow', 'Hb and lactic acid', 'hemoglobin (Hb) and lactic acid', 'ICAV of G1', 'obvious motor, sensory, or consciousness disturbance, and no neurological complications', 'carotids hemodynamics and perfusion flow', 'peak velocity of the internal carotid artery (ICAV) and the flow of the internal carotid artery (ICAF', 'Hb concentration', 'level of lactic acid at P3-P5', 'CCAV at T2-T6', 'perfusion flow']","[{'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0190173', 'cui_str': 'Heart valve replacement'}, {'cui': 'C0189969', 'cui_str': 'Correction of ventricular septal defect'}]","[{'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",45.0,0.0253174,"There was no significant difference in postoperative hospital stay, postoperative ICU time, and postoperative extubation time among the 3 groups (all  P >0.05).
","[{'ForeName': 'Yujiao', 'Initials': 'Y', 'LastName': 'Guan', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital, Central South University, Changsha 410008, China. guanyujiao8819@163.com.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital, Central South University, Changsha 410008, China.'}, {'ForeName': 'Zongbin', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital, Central South University, Changsha 410008, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital, Central South University, Changsha 410008, China. 13723887459@163.com.'}]",Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences,['10.11817/j.issn.1672-7347.2020.190283']
2382,33051424,"Changes in plasma levels of RIPK1, RIPK3, and MLKL in patients with coronary atherosclerotic heart disease and its clinical predictive value.","OBJECTIVES


Coronary atherosclerotic heart disease (CHD) is caused by coronary atherosclerosis, which leads to stenosis and even occlusion of the lumen, resulting in myocardial ischemia, and necrosis subsequently. Its prevalence has been high for a long time. The prevention and treatment of CHD are important. The study aimed to investigate the role of plasma levels of receptor-interacting protein kinase 1 (RIPK1), receptor-interacting protein kinase 3 (RIPK3), and mixed-lineage kinase domain-like protein (MLKL) in patients with CHD and its clinical predictive value.
METHODS


A total of 190 patients with CHD who were diagnosed by coronary angiography and 70 healthy subjects in cardiovascular department from September 2015 to May 2017 were enrolled in this study. Patients with CHD were assigned into 4 groups: Patients with stable angina pectoris (SAP,  n =46), patients with unstable angina pectoris (UAP,  n =56), patients with non-ST-segment elevation myocardial infarction (NSTEMI,  n =42), and patients with ST-segment elevation myocardial infarction (STEMI,  n =46). Patients with CHD were assigned into a single-vessel lesion group, a double-vessel lesion group, and a multi-vessel lesion group according to the results of coronary angiography, and the severity of coronary artery stenosis was determined by Gensini score. Plasma levels of RIPK1, RIPK3, and MLKL were measured by enzyme-linked immunosorbent assay (ELISA).
RESULTS


The plasma levels of RIPK1, RIPK3, and MLKL in patients with CHD were significantly higher than those in the controls ( P <0.05). The plasma levels of RIPK1, RIPK3, and MLKL in the UAP group were significantly higher than those in the SAP group ( P <0.05). The plasma levels of RIPK1, RIPK3, and MLKL in NSTEMI and STEMI group were significantly higher than those in the UAP group ( P <0.05). There was no significant difference between the NSTEMI group and STEMI group ( P >0.05). The plasma levels of RIPK1, RIPK3 and MLKL were significantly increased with numbers of coronary artery lesions ( P <0.05), which were positively correlated with Gensini scores. The multivariate logistic regression analysis showed that plasma levels of RIPK1, RIPK3, and MLKL were independent risk factors for severe coronary artery stenosis.The average period of follow-up was 24 months after hospital discharge. The patients were divided into 2 groups according to whether they had major adverse cardiovascular events (MACE). Compared with patient without MACE, patient with MACE had higher levels of RIPK1, RIPK3, and MLKL ( P <0.05). Receiver operator characteristic (ROC) curve analysis showed that the area under curve of RIPK1 was 0.72 ( P <0.001), the area under curve of RIPK3 was 0.83 ( P <0.001), and the area under curve of MLKL was 0.75 ( P <0.001).
CONCLUSIONS


Plasma levels of RIPK1, RIPK3, and MLKL are closely related to CHD, and they have predictive value for the prognosis evaluation for patients with CHD.",2020,"The plasma levels of RIPK1, RIPK3 and MLKL were significantly increased with numbers of coronary artery lesions ( P <0.05), which were positively correlated with Gensini scores.","['190 patients with CHD who were diagnosed by coronary angiography and 70 healthy subjects in cardiovascular department from September 2015 to May 2017 were enrolled in this study', 'patients with coronary atherosclerotic heart disease', 'Patients with CHD', 'patients with CHD', 'Patients with CHD were assigned into 4 groups: Patients with stable angina pectoris (SAP,  n =46), patients with unstable angina pectoris (UAP,  n =56), patients with non-ST-segment elevation myocardial infarction (NSTEMI,  n =42), and patients with ST-segment elevation myocardial infarction (STEMI,  n =46', 'patients with CHD and its clinical predictive value', 'Coronary atherosclerotic heart disease (CHD']","['UAP', 'single-vessel lesion group, a double-vessel lesion group, and a multi-vessel lesion']","['Plasma levels of RIPK1, RIPK3, and MLKL', 'plasma levels of RIPK1, RIPK3, and MLKL', 'major adverse cardiovascular events (MACE', 'area under curve of MLKL', 'levels of RIPK1, RIPK3, and MLKL', 'numbers of coronary artery lesions', 'area under curve of RIPK3', 'plasma levels of RIPK1, RIPK3 and MLKL']","[{'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C1740186', 'cui_str': 'SKAP2 protein, human'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}, {'cui': 'C4255010', 'cui_str': 'Non-ST-Elevation Myocardial Infarction'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0297981', 'cui_str': 'RIPK1 protein, human'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C1431040', 'cui_str': 'MAP3K13 protein, human'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",190.0,0.0193336,"The plasma levels of RIPK1, RIPK3 and MLKL were significantly increased with numbers of coronary artery lesions ( P <0.05), which were positively correlated with Gensini scores.","[{'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Xiao', 'Affiliation': 'Department of Cardiology, Xiangya Hospital, Central South University, Changsha 410008, China. 850256290@qq.com.'}, {'ForeName': 'Yinzhuang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Xiangya Hospital, Central South University, Changsha 410008, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Kuang', 'Affiliation': 'Department of Cardiology, Xiangya Hospital, Central South University, Changsha 410008, China.'}, {'ForeName': 'Qilin', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Xiangya Hospital, Central South University, Changsha 410008, China. mqilin2004@163.com.'}]",Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences,['10.11817/j.issn.1672-7347.2020.200026']
2383,33051441,Propranolol-induced inhibition of unconditioned stimulus-reactivated fear memory prevents the return of fear in humans.,"Fear memories can be reactivated by a fear-associated conditioned stimulus (CS) or unconditioned stimulus (US) and then undergo reconsolidation. Propranolol administration during CS retrieval-induced reconsolidation can impair fear memory that is specific to the reactivated CS. However, from a practical perspective, the US is often associated with multiple CSs, and each CS can induce a fear response. The present study sought to develop and test a US-based memory retrieval interference procedure with propranolol to disrupt the original fear memory and eliminate all CS-associated fear responses in humans. We recruited 127 young healthy volunteers and conducted three experiments. All of the subjects acquired fear conditioning, after which they received the β-adrenergic receptor antagonist propranolol (40 mg) or placebo (vitamin C) and were exposed to the US or CS to reactivate the original fear memory. Fear responses were measured. Oral propranolol administration 1 h before US retrieval significantly decreased subsequent fear responses and disrupted associations between all CSs and the US. However, propranolol administration before CS retrieval only inhibited the fear memory that was related to the reactivated CS. Moreover, the propranolol-induced inhibition of fear memory reconsolidation that was retrieved by the US had a relatively long-lasting effect (at least 2 weeks) and was also effective for remote fear memory. These findings indicate that the US-based memory retrieval interference procedure with propranolol can permanently decrease the fear response and prevent the return of fear for all CSs in humans. This procedure may open new avenues for treating fear-related disorders.",2020,Oral propranolol administration 1 h before US retrieval significantly decreased subsequent fear responses and disrupted associations between all CSs and the US.,"['humans', '127 young healthy volunteers']","['Propranolol', 'β-adrenergic receptor antagonist propranolol', 'propranolol', 'placebo (vitamin C', 'Oral propranolol']","['subsequent fear responses', 'Fear responses', 'fear response', 'fear memory']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0242889', 'cui_str': 'Substance with adrenergic receptor antagonist mechanism of action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",127.0,0.0126613,Oral propranolol administration 1 h before US retrieval significantly decreased subsequent fear responses and disrupted associations between all CSs and the US.,"[{'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No.2018RU006), Peking University, Beijing, China.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No.2018RU006), Peking University, Beijing, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Yuan', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No.2018RU006), Peking University, Beijing, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yao', 'Affiliation': 'Basic Medical College, Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Sijing', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Faculty of Medicine, Department of Psychiatry, Chinese University of Hong Kong, Sha Tin, Hong Kong SAR, China.'}, {'ForeName': 'Jianyu', 'Initials': 'J', 'LastName': 'Que', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No.2018RU006), Peking University, Beijing, China.'}, {'ForeName': 'Yimiao', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No.2018RU006), Peking University, Beijing, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'National Institute on Drug Dependence and Beijing Key Laboratory on Drug Dependence Research, Peking University, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'National Institute on Drug Dependence and Beijing Key Laboratory on Drug Dependence Research, Peking University, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'National Institute on Drug Dependence and Beijing Key Laboratory on Drug Dependence Research, Peking University, Beijing, China. yinghan@bjmu.edu.cn.'}, {'ForeName': 'Hongqiang', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No.2018RU006), Peking University, Beijing, China. sunhq@bjmu.edu.cn.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No.2018RU006), Peking University, Beijing, China. linlu@bjmu.edu.cn.'}]",Translational psychiatry,['10.1038/s41398-020-01023-w']
2384,33051487,Prostate cancer risk prediction using a polygenic risk score.,"Hereditary factors have a strong influence on prostate cancer (PC) risk and poorer outcomes, thus stratification by genetic factors addresses a critical need for targeted PC screening and risk-adapted follow-up. In this Finnish population-based retrospective study 2283 clinically diagnosed and 455 screen-detected patients from the Finnish Randomised Study of Screening for Prostate Cancer (FinRSPC), 2400 healthy individuals have been involved. Individual genetic risk through establishment of a polygenic risk score based on 55 PC risk SNPs identified through the Finnish subset of the Collaborative Oncological Gene-Environment Study was assessed. Men with PC had significantly higher median polygenic risk score compared to the controls (6.59 vs. 3.83, P < 0.0001). The polygenic risk score above the control median was a significant predictor of PC (OR 2.13, 95% CI 1.90-2.39). The polygenic risk score predicted the risk of PC with an AUC of 0.618 (95% CI 0.60-0.63). Men in the highest polygenic risk score quartile were 2.8-fold (95% CI 2.4-3.30) more likely to develop PC compared with men in the lowest quartile. In the FinRSPC cohort, a significantly higher percentage of men had a PSA level of ≥ 4 ng/mL in polygenic risk score quartile four compared to quartile one (18.7% vs 8.3%, P < 0.00001). Adding the PRS to a PSA-only model contributed additional information in predicting PC in the FinRSPC model. Results strongly suggest that use of the polygenic risk score would facilitate the identification of men at increased risk for PC.",2020,The polygenic risk score predicted the risk of PC with an AUC of 0.618 (95% CI 0.60-0.63).,"['Finnish population-based retrospective study 2283 clinically diagnosed and 455 screen-detected patients from the Finnish Randomised Study of Screening for Prostate Cancer (FinRSPC), 2400 healthy individuals have been involved']",[],"['highest polygenic risk score quartile', 'polygenic risk score quartile', 'median polygenic risk score', 'PSA level of\u2009≥', 'polygenic risk score', 'PC (OR']","[{'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",2400.0,0.0680311,The polygenic risk score predicted the risk of PC with an AUC of 0.618 (95% CI 0.60-0.63).,"[{'ForeName': 'Csilla', 'Initials': 'C', 'LastName': 'Sipeky', 'Affiliation': 'Institute of Biomedicine, University of Turku, Kiinamyllynkatu 10, 20520, Turku, Finland.'}, {'ForeName': 'Kirsi M', 'Initials': 'KM', 'LastName': 'Talala', 'Affiliation': 'Finnish Cancer Registry, Mass Screening Registry, Helsinki, Finland.'}, {'ForeName': 'Teuvo L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'Department of Urology, Tampere University Hospital and Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'Unit of Health Sciences, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schleutker', 'Affiliation': 'Institute of Biomedicine, University of Turku, Kiinamyllynkatu 10, 20520, Turku, Finland. johanna.schleutker@utu.fi.'}]",Scientific reports,['10.1038/s41598-020-74172-z']
2385,33051646,Lipoprotein(a) lowering by alirocumab reduces the total burden of cardiovascular events independent of low-density lipoprotein cholesterol lowering: ODYSSEY OUTCOMES trial.,"AIMS


Lipoprotein(a) concentration is associated with first cardiovascular events in clinical trials. It is unknown if this relationship holds for total (first and subsequent) events. In the ODYSSEY OUTCOMES trial in patients with recent acute coronary syndrome (ACS), the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab reduced lipoprotein(a), low-density lipoprotein cholesterol (LDL-C), and cardiovascular events compared with placebo. This post hoc analysis determined whether baseline levels and alirocumab-induced changes in lipoprotein(a) and LDL-C [corrected for lipoprotein(a) cholesterol] independently predicted total cardiovascular events.
METHODS AND RESULTS


Cardiovascular events included cardiovascular death, non-fatal myocardial infarction, stroke, hospitalization for unstable angina or heart failure, ischaemia-driven coronary revascularization, peripheral artery disease events, and venous thromboembolism. Proportional hazards models estimated relationships between baseline lipoprotein(a) and total cardiovascular events in the placebo group, effects of alirocumab treatment on total cardiovascular events by baseline lipoprotein(a), and relationships between lipoprotein(a) reduction with alirocumab and subsequent risk of total cardiovascular events. Baseline lipoprotein(a) predicted total cardiovascular events with placebo, while higher baseline lipoprotein(a) levels were associated with greater reduction in total cardiovascular events with alirocumab (hazard ratio Ptrend = 0.045). Alirocumab-induced reductions in lipoprotein(a) (median -5.0 [-13.6, 0] mg/dL) and corrected LDL-C (median -51.3 [-67.1, -34.0] mg/dL) independently predicted lower risk of total cardiovascular events. Each 5-mg/dL reduction in lipoprotein(a) predicted a 2.5% relative reduction in cardiovascular events.
CONCLUSION


Baseline lipoprotein(a) predicted the risk of total cardiovascular events and risk reduction by alirocumab. Lipoprotein(a) lowering contributed independently to cardiovascular event reduction, supporting the concept of lipoprotein(a) as a treatment target after ACS.",2020,"Each 5-mg/dL reduction in lipoprotein(a) predicted a 2.5% relative reduction in cardiovascular events.
",['patients with recent acute coronary syndrome (ACS'],"['placebo', 'alirocumab']","['total burden of cardiovascular events', 'total cardiovascular events', 'lipoprotein(a), low-density lipoprotein cholesterol (LDL-C), and cardiovascular events', 'lipoprotein(a', 'corrected LDL-C', 'baseline levels and alirocumab-induced changes in lipoprotein(a) and LDL-C [corrected for lipoprotein(a) cholesterol', 'risk of total cardiovascular events', 'cardiovascular death, non-fatal myocardial infarction, stroke, hospitalization for unstable angina or heart failure, ischaemia-driven coronary revascularization, peripheral artery disease events, and venous thromboembolism', 'cardiovascular events', 'total cardiovascular events by baseline lipoprotein(a), and relationships between lipoprotein(a) reduction with alirocumab and subsequent risk of total cardiovascular events', 'risk of total cardiovascular events and risk reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",,0.188713,"Each 5-mg/dL reduction in lipoprotein(a) predicted a 2.5% relative reduction in cardiovascular events.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'Department of Epidemiology and Biostatistics, State University of New York, Downstate School of Public Health, 450 Clarkson Avenue, MS 43, Brooklyn, NY 11203, USA.'}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, 701 19th Street South - LHRB 310, Birmingham, AL 35294, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Aylward', 'Affiliation': 'Department of Cardiology, South Australian Health and Medical Research Institute, Flinders University and Medical Centre, South Australia 5042, Australia.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Baccara-Dinet', 'Affiliation': 'Sanofi R&D, Global Development, 371 Rue du Professeur Blayac, 34080 Montpellier, France.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Paraguay 160, Rosario, Santa Fe, Rosario 2000, Argentina.'}, {'ForeName': 'Zlatko', 'Initials': 'Z', 'LastName': 'Fras', 'Affiliation': 'Preventive Cardiology Unit, Department of Vascular Medicine, Division of Medicine, University Medical Centre Ljubljana, Zaloška cesta 7, SI-1525 Ljubljana, Slovenia.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, 87 Ave NW, Edmonton, Alberta T6G 2E1, Canada.'}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Halvorsen', 'Affiliation': 'Department of Cardiology, Oslo Universitetssykehus HF Ulleval, and University of Oslo, Problemveien 7, 0315 Oslo, Norway.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University, 291 Campus Drive, Li Ka Shing Building, Stanford, CA 94305-5101, USA.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Moriarty', 'Affiliation': 'Clinical Pharmacology-University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals, 777 Old Saw Mill River Rd., Tarrytown, NY 10591, USA.'}, {'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, Reynolds Building, St Dunstans Road, London W6 8RP, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sinnaeve', 'Affiliation': 'Department of Cardiovascular Medicine, University Hospitals Leuven, Herestraat 49, Leuven 3000, Belgium.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsimikas', 'Affiliation': 'Sulpizio Cardiovascular Center, Division of Cardiovascular Medicine, University of California San Diego, 9434 Medical Center Dr, La Jolla, CA 92037, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vogel', 'Affiliation': 'Department of Medicine, University of Colorado Denver, 13001 E 17th Pl, Aurora, CO 80045, USA.'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services, Auckland City Hospital, 5 Park Road, Grafton, Auckland 1142, New Zealand.'}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Zahger', 'Affiliation': 'Department of Cardiology, Soroka University Medical Center, Faculty of Health Sciences, Ben Gurion University of the Negev, PO Box 151 Beer Sheva 8410, Israel.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Theodor-Stern-Kai 7, Frankfurt am Main 60590, Germany.'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Université de Paris, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, 46 Rue Henri Huchard, Paris 75018, France.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Box B130, Aurora, CO 80045, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehaa649']
2386,33051649,Time-of-day and meal size effects on clinical lipid markers.,"CONTEXT


Dyslipidemia and cardiovascular disease are common in shift workers and eating at night may contribute to this pathophysiology.
OBJECTIVE


To examine the effects of eating at different times of day on lipid profiles.
DESIGN


Two 24-hour baseline days with 8 hours of sleep, 3 meals (breakfast, lunch, dinner) and a snack, followed by a 40-hour constant routine (CR) with hourly isocaloric meals.
SETTING


Intensive Physiological Monitoring Unit, Brigham and Women's Hospital.
PARTICIPANTS


Twenty-one healthy adults [23.4 ± 2.7 years, 5F].
INTERVENTION


Forty-hour CR.
MAIN OUTCOME MEASURES


A standard clinical lipid panel [total cholesterol, triglyceride (TG) and high- (HDL-C), and low- (LDL-C) density lipoproteins] was assayed in blood samples collected 4-hourly across ~4 days.
RESULTS


When participants ate at night, levels of TG were similar to eating during the day, however, these levels at night were reached with consuming approximately half the calories. Additionally, 24-hour levels of TG were 10% higher when meals were consumed hourly across 24 hours compared to consuming a typical 3-meal schedule while awake during the day and sleeping at night. The endogenous circadian rhythms of TG, which peaked at night, were shifted earlier by ~10 hours under baseline conditions whereas the rhythms in total cholesterol, HDL-C or LDL-C remained unchanged and peaked in the afternoon.
CONCLUSIONS


The time-of-day dependency on postprandial lipid metabolism, which leads to hypersensitivity in TG responses when eating at night, may underlie the dyslipidemia and elevated cardiovascular disease risk observed in shift workers.",2020,"hours under baseline conditions whereas the rhythms in total cholesterol, HDL-C or LDL-C remained unchanged and peaked in the afternoon.
","['Twenty-one healthy adults [23.4 ± 2.7 years, 5F', ""Intensive Physiological Monitoring Unit, Brigham and Women's Hospital""]",['40-hour constant routine (CR) with hourly isocaloric meals'],"['24-hour levels of TG', 'standard clinical lipid panel [total cholesterol, triglyceride (TG) and high- (HDL-C), and low- (LDL-C) density lipoproteins', 'clinical lipid markers', 'postprandial lipid metabolism', 'total cholesterol, HDL-C or LDL-C']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026429', 'cui_str': 'Physiologic Monitoring'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0200382', 'cui_str': 'Lipid panel'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",21.0,0.0370722,"hours under baseline conditions whereas the rhythms in total cholesterol, HDL-C or LDL-C remained unchanged and peaked in the afternoon.
","[{'ForeName': 'Leilah K', 'Initials': 'LK', 'LastName': 'Grant', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Czeisler', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Shadab A', 'Initials': 'SA', 'LastName': 'Rahman', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa739']
2387,33051650,Antifungal susceptibility does not correlate with fungal clearance or survival in AIDS-associated cryptococcal meningitis.,"We investigated the value of susceptibility testing in predicting response in AIDS-associated cryptococcal meningitis using clinical isolates from a randomized controlled trial of antifungal treatment (amphotericin monotherapy, amphotericin with flucytosine, or amphotericin with fluconazole). We found no correlation between antifungal susceptibility and either early or late survival, or fungal clearance.",2020,"We found no correlation between antifungal susceptibility and either early or late survival, or fungal clearance.",[],"['antifungal treatment (amphotericin monotherapy, amphotericin with flucytosine, or amphotericin with fluconazole']","['antifungal susceptibility and either early or late survival, or fungal clearance']",[],"[{'cui': 'C2363963', 'cui_str': 'Antifungal treatment'}, {'cui': 'C0085795', 'cui_str': 'Amphotericin'}, {'cui': 'C0016278', 'cui_str': 'Flucytosine'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}]","[{'cui': 'C0003308', 'cui_str': 'Antifungal-containing product'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0521033', 'cui_str': 'fungi'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.0494054,"We found no correlation between antifungal susceptibility and either early or late survival, or fungal clearance.","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': ""O'Connor"", 'Affiliation': 'Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Duong', 'Initials': 'D', 'LastName': 'Van Anh', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Tran Thi Hong', 'Initials': 'TTH', 'LastName': 'Chau', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Nguyen Van Vinh', 'Initials': 'NVV', 'LastName': 'Chau', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Lan Nguyen Phu', 'Initials': 'LNP', 'LastName': 'Huong', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Wolbers', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Jeremy N', 'Initials': 'JN', 'LastName': 'Day', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1544']
2388,33051719,"Efficacy of Topical Tranexamic Acid (Cyclokapron) in ""Wet"" Field Infiltration with Dilute Local Anaesthetic Solutions in Plastic Surgery.","BACKGROUND


Surgical bleeding may lead to the need for blood transfusion and minimizing blood loss has been a basic principle followed by surgeons for generations. Antifibrinolytic agents are widely used to reduce perioperative haemorrhage. The present study sought to assess the efficacy of directly infiltrated tranexamic acid in ameliorating bruising in participants undergoing cosmetic plastic surgery (liposuction).
MATERIALS AND METHODS


The study employed a blinded, prospective, randomized, case control design. Thirty-three patients were studied. Tranexamic acid free infiltration tumescent solution (saline, bupivacaine lignocaine and adrenalin) was infiltrated to one flank of patients undergoing liposuction of flanks. The other flank was infiltrated with the same tumescent solution (saline, bupivacaine lignocaine and adrenalin) mixed with tranexamic acid (0.1%). Bruises were photographed one and seven days after surgery and measured for size. The surface area of the bruises was calculated using ImageJ software. We compared the bruised surface are between the tranexamic acid infiltrated flank and non-tranexamic acid infiltrated flank in the same patient. The model employed involved measuring the bruises on each flank of the same patient, with surgery by a single surgeon using the same infiltration and surgical techniques for both sides. The only variable was the difference in tranexamic acid concentration between study and control flanks.
RESULTS


We found that use of tranexamic acid consistently resulted in a smaller bruise area on days one and seven after liposuction of flanks. Results were statistically significant.
CONCLUSIONS


This is the first study examining addition of tranexamic acid to a tumescent infiltration solution-to produce a predictable local concentration of tranexamic acid-in order to maximize surgical site effect and minimize systemic effect. The authors recommend incorporation of tranexamic acid as a routine component along with adrenaline and local anaesthetics in tumescent field infiltration solution 10-15 min before commencement of the cosmetic surgery.
LEVEL OF EVIDENCE II


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2020,We compared the bruised surface are between the tranexamic acid infiltrated flank and non-tranexamic acid infiltrated flank in the same patient.,"['patients undergoing liposuction of flanks', 'Plastic Surgery', 'Thirty-three patients were studied', 'participants undergoing cosmetic plastic surgery (liposuction']","['Tranexamic acid free infiltration tumescent solution (saline, bupivacaine lignocaine and adrenalin', 'Topical Tranexamic Acid (Cyclokapron', 'tranexamic acid', 'tumescent solution (saline, bupivacaine lignocaine and adrenalin) mixed with tranexamic acid']","['tranexamic acid concentration', 'perioperative haemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038640', 'cui_str': 'Liposuction of subcutaneous tissue'}, {'cui': 'C0230171', 'cui_str': 'Structure of lateral region of abdomen'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4546042', 'cui_str': 'Perioperative hemorrhage'}]",33.0,0.140906,We compared the bruised surface are between the tranexamic acid infiltrated flank and non-tranexamic acid infiltrated flank in the same patient.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fayman', 'Affiliation': 'Netcare Rosebank Hospital, 14 Sturdee Ave, Rosebank, Johannesburg, 2196, South Africa. info@doctorfayman.co.za.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Beeton', 'Affiliation': 'Netcare Rosebank Hospital, 14 Sturdee Ave, Rosebank, Johannesburg, 2196, South Africa.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Potgieter', 'Affiliation': 'Netcare Rosebank Hospital, 14 Sturdee Ave, Rosebank, Johannesburg, 2196, South Africa.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ndou', 'Affiliation': 'Anatomy Department, Sefako Mokgatho Health Sciences University, Molotlegi Street, Pretoria, 0204, South Africa.'}, {'ForeName': 'Pedzisai', 'Initials': 'P', 'LastName': 'Mazengenya', 'Affiliation': 'College of Medicine, Ajman University, Ajman, United Arab Emirates.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-02001-9']
2389,33051743,"ASO Author Reflections: A Novel Technique for Single Layer Pancreatojejunostomy is not Inferior to Modified Blumgart Anastomosis in Robotic Pancreatoduodenectomy-Results of a Randomized, Controlled Trial.",,2020,,['ASO Author Reflections'],[],[],"[{'cui': 'C0003436', 'cui_str': 'Antistreptolysin O'}, {'cui': 'C3812881', 'cui_str': 'Author'}]",[],[],,0.0959316,,"[{'ForeName': 'Qu', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Faculty of Hepatopancreatobiliary Surgery, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ""Faculty of Hepatopancreatobiliary Surgery, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China. Liurong301@126.com.""}]",Annals of surgical oncology,['10.1245/s10434-020-09237-4']
2390,33051759,Teaching surgery novices and trainees advanced laparoscopic suturing: a trial and tribulations.,"INTRODUCTION


The benefits of minimally invasive surgery are numerous; however, considerable variability exists in its application and there is a lack of standardized training for important advanced skills. Our goal was to determine whether participation in an advanced laparoscopic curriculum (ALC) results in improved laparoscopic suturing skills.
METHODS AND PROCEDURES


Study design was a prospective, randomized controlled trial. Surgery novices and trainees underwent baseline FLS training and were pre-tested on bench models. Participants were stratified by pre-test score and randomized to undergo either further FLS training (control group) or ALC training (intervention group). All were post-tested on the same bench model. Tests for differences between post-test scores of cohorts were performed using least squared means. Multivariable regression identified predictors of post-test score, and Wilcoxon rank sum test assessed for differences in confidence improvement in laparoscopic suturing ability between groups.
RESULTS


Between November 2018 and May 2019, 25 participants completed the study (16 females; 9 males). After adjustment for relevant variables, participants randomized to the ALC group had significantly higher post-test scores than those undergoing FLS training alone (mean score 90.50 versus 82.99, p = 0.001). The only demographic or other variables found to predict post-test score include level of training (p = 0.049) and reported years of video gaming (p = 0.034). There was no difference in confidence improvement between groups.
CONCLUSIONS


Training using the ALC as opposed to basic laparoscopic skills training only is associated with superior advanced laparoscopic suturing performance without affecting improvement in reported confidence levels. Performance on advanced laparoscopic suturing tasks may be predicted by lifetime cumulative video gaming history and year of training but does not appear to be associated with other factors previously studied in relation to basic laparoscopic skills, such as surgical career aspiration or musical ability.",2020,"CONCLUSIONS


Training using the ALC as opposed to basic laparoscopic skills training only is associated with superior advanced laparoscopic suturing performance without affecting improvement in reported confidence levels.","['25 participants completed the study (16 females; 9 males', 'Between November 2018 and May 2019']","['advanced laparoscopic curriculum (ALC', 'ALC', 'trainees advanced laparoscopic suturing', 'FLS training (control group) or ALC training (intervention group', 'baseline FLS training']","['higher post-test scores', 'years of video gaming', 'confidence improvement']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.214524,"CONCLUSIONS


Training using the ALC as opposed to basic laparoscopic skills training only is associated with superior advanced laparoscopic suturing performance without affecting improvement in reported confidence levels.","[{'ForeName': 'Arianne T', 'Initials': 'AT', 'LastName': 'Train', 'Affiliation': 'Department of Surgery, University at Buffalo, State University of New York Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA. ariannet@buffalo.edu.'}, {'ForeName': 'Jinwei', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Surgery, University at Buffalo, State University of New York Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'J Reinier F', 'Initials': 'JRF', 'LastName': 'Narvaez', 'Affiliation': 'Department of Surgery, University at Buffalo, State University of New York Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Lorin M', 'Initials': 'LM', 'LastName': 'Towle-Miller', 'Affiliation': 'Department of Biostatistics, University at Buffalo, State University of New York School of Public Health and Health Professions, Buffalo, NY, USA.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Wilding', 'Affiliation': 'Department of Biostatistics, University at Buffalo, State University of New York School of Public Health and Health Professions, Buffalo, NY, USA.'}, {'ForeName': 'Lora', 'Initials': 'L', 'LastName': 'Cavuoto', 'Affiliation': 'Department of Industrial and Systems Engineering, University at Buffalo, State University of New York School of Engineering and Applied Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Noyes', 'Affiliation': 'Department of Epidemiology and Environmental Health, University at Buffalo, State University of New York School of Public Health and Health Professions, Buffalo, NY, USA.'}, {'ForeName': 'Aaron B', 'Initials': 'AB', 'LastName': 'Hoffman', 'Affiliation': 'Department of Surgery, University at Buffalo, State University of New York Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Schwaitzberg', 'Affiliation': 'Department of Surgery, University at Buffalo, State University of New York Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}]",Surgical endoscopy,['10.1007/s00464-020-08067-5']
2391,33051793,Remote Ischemic Pre-conditioning in Subarachnoid Hemorrhage: A Prospective Pilot Trial.,"BACKGROUND


Cerebral injury from aneurysmal subarachnoid hemorrhage (aSAH) is twofold. The initial hemorrhage causes much of the injury; secondary injury can occur from delayed cerebral ischemia (DCI). Remote ischemic preconditioning (RIPC) is a mechanism of organ protection in response to transient ischemia within a distant organ. This pilot trial sought to apply RIPC in patients with aSAH to evaluate its effect on secondary cerebral injury and resultant outcomes.
METHODS


Patients were randomized to the high-pressure occlusion group (HPO) or the low-pressure occlusion group (LPO). Lower extremity RIPC treatment was initiated within 72 h of symptom onset and every other day for 14 days or until Intensive Care Unit (ICU) discharge. In HPO, each treatment consisted of 4 five-minute cycles of manual blood pressure cuff inflation with loss of distal pulses. LPO received cuff inflation with lower pressures while preserving distal pulses. Retrospectively matched controls were also analyzed. Efficacy of treatment was measured by total days spent in vasospasm out of study enrollment days, hospital and ICU length of stay (LOS), cerebral infarction, one and six month modified Rankin score, and mortality.
RESULTS


The final analysis included 33 patients with 11 in each group. Patient demographics, aneurysm location, admission airway status, Glasgow Coma Scale (GCS), modified Rankin score, Hunt and Hess score, modified Fisher Score and aneurysm management were not significantly different between groups. Hospital and ICU LOS was shorter in LPO compared to the control (p = 0·0468 and p = 0·0409, respectively). Total vasospasm days/study enrollment days, cerebral infarction, one and six month modified Rankin score, and mortality were not significantly different between the groups.
CONCLUSIONS


This pilot trial did demonstrate feasibility and safety. The shortened LOS in the LPO may implicate a protective role of RIPC and warrants future study.",2020,"Hospital and ICU LOS was shorter in LPO compared to the control (p = 0·0468 and p = 0·0409, respectively).","['Patients', 'Subarachnoid Hemorrhage', 'patients with aSAH', 'Cerebral injury from aneurysmal subarachnoid hemorrhage (aSAH', '33 patients with 11 in each group']","['high-pressure occlusion group (HPO) or the low-pressure occlusion group (LPO', 'Remote Ischemic Pre-conditioning', 'Remote ischemic preconditioning (RIPC']","['delayed cerebral ischemia (DCI', 'hospital and ICU length of stay (LOS), cerebral infarction, one and six month modified Rankin score, and mortality', 'Total vasospasm days/study enrollment days, cerebral infarction, one and six month modified Rankin score, and mortality', 'Hospital and ICU LOS', 'Patient demographics, aneurysm location, admission airway status, Glasgow Coma Scale (GCS), modified Rankin score, Hunt and Hess score, modified Fisher Score and aneurysm management']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}]","[{'cui': 'C4761225', 'cui_str': 'Delayed cerebral ischaemia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C3888574', 'cui_str': 'Modified Rankin score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",33.0,0.113229,"Hospital and ICU LOS was shorter in LPO compared to the control (p = 0·0468 and p = 0·0409, respectively).","[{'ForeName': 'Ronak N', 'Initials': 'RN', 'LastName': 'Raval', 'Affiliation': 'Department of Anesthesiology and Critical Care Center, Loma Linda University Medical Center, 11234 Anderson Street, Loma Linda, CA, 92354, USA. rraval@llu.edu.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Small', 'Affiliation': 'Department of Anesthesiology, Swedish Medical Center, Seattle, USA.'}, {'ForeName': 'Kristel', 'Initials': 'K', 'LastName': 'Magsino', 'Affiliation': 'Department of Anesthesiology and Critical Care Center, Loma Linda University Medical Center, 11234 Anderson Street, Loma Linda, CA, 92354, USA.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Chakravarthy', 'Affiliation': 'Department of Neurosurgery, Cleveland Clinic of Case Western Reserve School of Medicine, Cleveland, USA.'}, {'ForeName': 'Briahnna', 'Initials': 'B', 'LastName': 'Austin', 'Affiliation': 'Department of Anesthesiology and Critical Care Center, Loma Linda University Medical Center, 11234 Anderson Street, Loma Linda, CA, 92354, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Applegate', 'Affiliation': 'Department of Anesthesiology, Davis Medical Center, University of California, Sacramento, USA.'}, {'ForeName': 'Ihab', 'Initials': 'I', 'LastName': 'Dorotta', 'Affiliation': 'Department of Anesthesiology and Critical Care Center, Loma Linda University Medical Center, 11234 Anderson Street, Loma Linda, CA, 92354, USA.'}]",Neurocritical care,['10.1007/s12028-020-01122-y']
2392,33051814,Is the only buccal infiltration anesthesia enough for extraction of mandibular anterior incisors and premolar teeth? A split-mouth randomized clinical trial.,"OBJECTIVES


The issue of needing additional lingual injection in extractions of mandibular premolar and incisors is still not clarified. The aim of this study is to investigate whether it is necessary to perform lingual injection in addition to buccal infiltration anesthesia in mandibular incisors and premolar teeth extractions.
MATERIALS AND METHODS


Sixty-six patients who admitted to our clinic for the removal of bilateral mandibular anterior teeth were included in the present study. Patients were divided into two groups. The experimental group received only 1.5 ml of 2% lidocaine with 1:80,000 epinephrine by injection into the buccal vestibule of the tooth. The control group received 1.5 ml of 2% lidocaine with 1:80,000 epinephrine by buccal injection into the buccal side and 0.3 ml same lidocaine solution injected into the lingual side of the tooth. After 5 min, tooth was extracted and each patient was asked to record the intensity of injection and extraction pain by 0-100 mm and a 10-point Visual Analogue Scale (VAS) and six-pointed Face Pain Scale (FPS).
RESULTS


The injection pain scores were significantly higher in terms of the VAS 0-10 point and 0-100 mm and FPS in the control group to which additional lingual injections were applied than the experimental group (p < 0.05). No statistically significant differences were found in all three scales between the groups in terms of extraction pain (p > 0.05). The mean extraction pain scores were lower in the experimental group according to the three scales. No additional anesthetic injection and post-operative complications were observed in all patients.
CONCLUSIONS


The extraction of mandibular incisors and premolar teeth can only be done with only the buccal infiltration.
CLINICAL RELEVANCE


In the extraction of mandibular anterior teeth, it can be performed with less anesthetic amount without the need for an additional lingual injection.",2020,The injection pain scores were significantly higher in terms of the VAS 0-10 point and 0-100 mm and FPS in the control group to which additional lingual injections were applied than the experimental group (p < 0.05).,"['Sixty-six patients who admitted to our clinic for the removal of bilateral mandibular anterior teeth were included in the present study', 'mandibular incisors and premolar teeth extractions']","['lidocaine with 1:80,000 epinephrine', 'lidocaine solution']","['extraction pain', 'mean extraction pain scores', 'injection pain scores', '10-point Visual Analogue Scale (VAS) and six-pointed Face Pain Scale (FPS']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",66.0,0.0421419,The injection pain scores were significantly higher in terms of the VAS 0-10 point and 0-100 mm and FPS in the control group to which additional lingual injections were applied than the experimental group (p < 0.05).,"[{'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Ege', 'Affiliation': 'Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Adıyaman University, 02200, Adıyaman, Turkey. miregein@gmail.com.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Demirkol', 'Affiliation': 'Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Gaziantep University, Gaziantep, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-020-03628-3']
2393,33051867,Developing a fidelity measure of early intervention programs for children with neuromotor disorders.,"AIM


To describe the development of an intervention-specific fidelity measure and its utilization and to determine whether the newly developed Sitting Together and Reaching to Play (START-Play) intervention was implemented as intended. Also, to quantify differences between START-Play and usual early intervention (uEI) services.
METHOD


A fidelity measure for the START-Play intervention was developed for children with neuromotor disorders by: (1) identifying key intervention components, (2) establishing a measurement coding system, and (3) testing the reliability of instrument scores. After establishing acceptable interrater reliability, 103 intervention videos from the START-Play randomized controlled trial were coded and compared between the START-Play and uEI groups to measure five dimensions of START-Play fidelity, including adherence, dosage, quality of intervention, participant responsiveness, and program differentiation.
RESULTS


Fifteen fidelity variables out of 17 had good to excellent interrater reliability evidence with intraclass correlation coefficients (ICCs) ranging from 0.77 to 0.95. The START-Play therapists met the criteria for acceptable fidelity of the intervention (rates of START-Play key component use ≥0.8; quality ratings ≥3 [on a scale of 1-4]). The START-Play and uEI groups differed significantly in rates of START-Play key component use and quality ratings.
INTERPRETATION


The START-Play fidelity measure successfully quantified key components of the START-Play intervention, serving to differentiate START-Play from uEI.",2020,The START-Play therapists met the criteria for acceptable fidelity of the intervention (rates of START-Play key component use ≥0.8; quality ratings ≥3 [on a scale of 1-4]).,"['children with neuromotor disorders by', 'children with neuromotor disorders']","['START-Play intervention', 'newly developed Sitting Together and Reaching to Play (START-Play) intervention']","['rates of START-Play key component use and quality ratings', 'START-Play fidelity, including adherence, dosage, quality of intervention, participant responsiveness, and program differentiation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}]",,0.0176289,The START-Play therapists met the criteria for acceptable fidelity of the intervention (rates of START-Play key component use ≥0.8; quality ratings ≥3 [on a scale of 1-4]).,"[{'ForeName': 'Mihee', 'Initials': 'M', 'LastName': 'An', 'Affiliation': 'Department of Physical Therapy, Kaya University, Gimhae, Republic of Korea.'}, {'ForeName': 'Jayden', 'Initials': 'J', 'LastName': 'Nord', 'Affiliation': 'Nebraska Center for Research on Children, Youth, Families and Schools, University of Nebraska, Lincoln, NE, USA.'}, {'ForeName': 'Natalie A', 'Initials': 'NA', 'LastName': 'Koziol', 'Affiliation': 'Nebraska Center for Research on Children, Youth, Families and Schools, University of Nebraska, Lincoln, NE, USA.'}, {'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Dusing', 'Affiliation': 'Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Audrey E', 'Initials': 'AE', 'LastName': 'Kane', 'Affiliation': 'Department of Physical Therapy, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Michele A', 'Initials': 'MA', 'LastName': 'Lobo', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Mccoy', 'Affiliation': 'Department of Physical Therapy, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Regina T', 'Initials': 'RT', 'LastName': 'Harbourne', 'Affiliation': 'Department of Physical Therapy, Duquesne University, Pittsburgh, PA, USA.'}]",Developmental medicine and child neurology,['10.1111/dmcn.14702']
2394,33051871,First-year complications after immediate breast reconstruction with a biological and a synthetic mesh in the same patient: A randomized controlled study.,"BACKGROUND


Even though meshes and matrices are widely used in breast reconstruction, there is little high-quality scientific evidence for their risks and benefits. The aim of this study was to compare first-year surgical complication rates in implant-based immediate breast reconstruction with a biological mesh with that of a synthetic mesh, in the same patient.
METHODS


This study is a clinical, randomized, prospective trial. Patients operated on with bilateral mastectomy and immediate breast reconstruction were randomized to biological mesh on one side and synthetic mesh on the other side.
RESULTS


A total of 48 breasts were randomized. As the synthetically and the biologically reconstructed breasts that were compared belonged to the same woman, systemic factors were exactly the same in the two groups. The most common complication was seroma formation with a frequency of 38% in the biological group and 3.8% in the synthetical group (p = .011). A higher frequency of total implant loss could be seen in the biologic mesh group (8.5% vs. 2%), albeit not statistically significant (p = .083).
CONCLUSIONS


In the same patient, a synthetic mesh seems to yield a lower risk for serious complications, such as implant loss, than a biological mesh.",2020,"A higher frequency of total implant loss could be seen in the biologic mesh group (8.5% vs. 2%), albeit not statistically significant (p = .083).
","['A total of 48 breasts', 'Patients operated on with bilateral mastectomy and immediate breast reconstruction']","['biological mesh on one side and synthetic mesh on the other side', 'immediate breast reconstruction with a biological and a synthetic mesh', 'implant-based immediate breast reconstruction with a biological mesh with that of a synthetic mesh']","['total implant loss', 'seroma formation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0191877', 'cui_str': 'Bilateral mastectomy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}]","[{'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",48.0,0.0568163,"A higher frequency of total implant loss could be seen in the biologic mesh group (8.5% vs. 2%), albeit not statistically significant (p = .083).
","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hansson', 'Affiliation': 'Department of Plastic Surgery, Institute of Clinical Sciences, The Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Ann-Chatrin', 'Initials': 'AC', 'LastName': 'Edvinsson', 'Affiliation': 'Department of Plastic Surgery, Institute of Clinical Sciences, The Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Elander', 'Affiliation': 'Department of Plastic Surgery, Institute of Clinical Sciences, The Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Kölby', 'Affiliation': 'Department of Plastic Surgery, Institute of Clinical Sciences, The Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Hallberg', 'Affiliation': 'Department of Plastic Surgery, Institute of Clinical Sciences, The Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}]",Journal of surgical oncology,['10.1002/jso.26227']
2395,33051948,Objectively measured sleep fragmentation is associated with incident delirium in older hospitalized patients: Analysis of data collected from an randomized controlled trial.,"Delirium may lead to poor outcomes in hospitalized older adults, and sleep deprivation may contribute to its pathogenesis. Thus, we sought to measure sleep duration and fragmentation using wrist-worn actigraphy in older, hospitalized patients with and without delirium, and to determine if actigraphy-based parameters could be used to predict delirium prior to clinical recognition. We conducted a secondary analysis of data from a recent, randomized clinical trial aimed at preventing inpatient delirium. Participants (n = 70) were aged ≥ 65 years admitted to an internal medicine service. Delirium was defined by the Confusion Assessment Method, or altered mental status identified by a clinician. Sleep measurements were actigraphy-based, and included total sleep time, median sleep bout duration and other measures of sleep fragmentation. We found that total sleep duration was similar between patients with (n = 17) and without (n = 53) delirium (mean 384.9 ± SD 162.7 versus mean 456.6 ± SD 135.8 min; p = .081). Mean sleep bout times were shorter in delirious versus never-delirious patients (median 6.1 [interquartile range 4.3-8.9] versus 7.9 [interquartile range 5.7-11.3] min, p = .048). Patients with delirium had more short sleep bouts (< 10 min) and fewer longer sleep bouts (> 30 min) compared with those without delirium. Increased sleep fragmentation was present prior to the clinical recognition of delirium. Overall, delirium was associated with increased sleep fragmentation detected by actigraphy, and sleep fragmentation might be useful as a biomarker for delirium prediction in the future.",2020,"Mean sleep bout times were shorter in delirious versus never-delirious patients (median 6.1 [interquartile range 4.3-8.9] versus 7.9 [interquartile range 5.7-11.3] min, p = .048).","['Participants (n\xa0=\xa070) were aged\xa0≥', 'patients with (n\xa0=\xa017) and without (n\xa0=\xa053) delirium (mean 384.9\xa0±\xa0SD 162.7 versus mean 456.6\xa0±', 'hospitalized older adults', 'older hospitalized patients', '65\u2005years admitted to an internal medicine service', 'older, hospitalized patients with and without delirium']",[],"['sleep fragmentation', 'Mean sleep bout times', 'short sleep bouts', 'Delirium', 'longer sleep bouts', 'total sleep time, median sleep bout duration and other measures of sleep fragmentation', 'total sleep duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",[],"[{'cui': 'C0751507', 'cui_str': 'Sleep Fragmentation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}]",70.0,0.131322,"Mean sleep bout times were shorter in delirious versus never-delirious patients (median 6.1 [interquartile range 4.3-8.9] versus 7.9 [interquartile range 5.7-11.3] min, p = .048).","[{'ForeName': 'Stuti J', 'Initials': 'SJ', 'LastName': 'Jaiswal', 'Affiliation': 'The Scripps Research Institute, La Jolla, CA, USA.'}, {'ForeName': 'Dae Y', 'Initials': 'DY', 'LastName': 'Kang', 'Affiliation': 'Division of Pulmonary, Critical Care & Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA, USA.'}, {'ForeName': 'Nathan E', 'Initials': 'NE', 'LastName': 'Wineinger', 'Affiliation': 'The Scripps Research Institute, La Jolla, CA, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Owens', 'Affiliation': 'Division of Pulmonary, Critical Care & Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA, USA.'}]",Journal of sleep research,['10.1111/jsr.13205']
2396,33040778,Effects of Dengzhan Shengmai Capsule combined with butylphthalide soft capsule on oxidative stress indexes and serum Hcy and CRP levels in patients with vascular dementia.,"This experiment was aimed to investigate the effect of Dengzhan Shengmai capsule combined with butylphthalide soft capsule on oxidative stress indexes and serum homocysteine (Hcy) and C-reactive protein (CRP) levels in patients with vascular dementia (VD). From July 2017 to July 2019, 123 patients with VD in our hospital were selected as the research object, and each patient was assigned a random number according to the order of treatment. Among them, No. 1 to 41 were the control group A, No. 42 to 82 were the control group B, and No. 83 to 123 were the research group. Control group A was given butylphthalide soft capsules, control group B was Dengzhanshengmai capsules, and the research group was given Dengzhanshengmai capsules combined with butylphthalide softgels. Comparison of clinical efficacy, the incidence of adverse reactions, and improvement of symptoms [Montreal Cognitive Assessment Scale (MocA) score, Vascular Dementia TCM Syndrome Differentiation Scale (SDSVD) score], vascular endothelial function [NO, endothelin 1 (ET-1)], oxidative stress [lipid peroxide (LPO), superoxide dismutase (SOD), C Dialdehyde (MDA)], endoplasmic reticulum stress response (Hcy, CRP) related indicators before and after treatment in three groups. Results showed that the total effective rate of treatment in the study group was higher than that in the control groups A and B, the difference was statistically significant (p&lt;0.05). In symptom improvement, the MoCA score of the study group was higher than that of the control groups A and B after the treatment course, and the SDSVD score was lower than that of the control groups A and B (p&lt;0.05); In the vascular endothelial function section, after the course of treatment, the serum NO level in the study group was higher than that in the control groups A and B, and the ET-1 level was lower than that in the control groups A and B (p&lt;0.05). In oxidative stress experiment, after the course of treatment in the study group, the serum LPO and MDA levels were lower than those in the control groups A and B, and the SOD levels were higher than those in the control groups A and B (p&lt;0.05).  Endoplasmic reticulum stress response results showed that after the course of treatment in the study group, the serum Hcy and CRP levels were lower than those in the control groups A and B (p&lt;0.05). In adverse reactions section, there was no significant difference in the incidence of adverse reactions among the three groups (p&gt;0.05). Dengzhan Shengmai Capsule combined with butylphthalide soft capsule is the first treatment for VD, with definite curative effect, which can effectively reduce the damage of vascular endothelial function and inhibit oxidative stress response, antagonize the endoplasmic reticulum stress response, thereby further alleviating dementia symptoms and improving cognitive function.",2020,"In symptom improvement, the MoCA score of the study group was higher than that of the control groups A and B after the treatment course, and the SDSVD score was lower than that of the control groups A and B (p&lt;0.05); In the vascular endothelial function section, after the course of treatment, the serum","['From July 2017 to July 2019, 123 patients with VD in our hospital', 'patients with vascular dementia (VD', 'patients with vascular dementia']","['Dengzhanshengmai capsules combined with butylphthalide softgels', 'Dengzhan Shengmai Capsule combined with butylphthalide soft capsule', 'Dengzhan Shengmai capsule combined with butylphthalide soft capsule']","['ET-1 level', 'SDSVD score', 'SOD levels', 'adverse reactions, and improvement of symptoms [Montreal Cognitive Assessment Scale (MocA) score, Vascular Dementia TCM Syndrome Differentiation Scale (SDSVD) score], vascular endothelial function [NO, endothelin 1 (ET-1)], oxidative stress [lipid peroxide (LPO), superoxide dismutase (SOD), C Dialdehyde (MDA)], endoplasmic reticulum stress response (Hcy, CRP', 'oxidative stress indexes and serum Hcy and CRP levels', 'serum Hcy and CRP levels', 'total effective rate', 'Endoplasmic reticulum stress response', 'incidence of adverse reactions', 'oxidative stress indexes and serum homocysteine (Hcy) and C-reactive protein (CRP) levels', 'MoCA score', 'serum LPO and MDA levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011269', 'cui_str': 'Vascular dementia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0047625', 'cui_str': '3-n-butylphthalide'}, {'cui': 'C4506831', 'cui_str': 'dengzhan shengmai capsule'}, {'cui': 'C1273639', 'cui_str': 'Soft capsule'}]","[{'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011269', 'cui_str': 'Vascular dementia'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0023776', 'cui_str': 'Fatty Acid Hydroperoxides'}, {'cui': 'C3178870', 'cui_str': 'Stress, Endoplasmic Reticulum'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0031180', 'cui_str': 'Peroxide'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}]",123.0,0.0173379,"In symptom improvement, the MoCA score of the study group was higher than that of the control groups A and B after the treatment course, and the SDSVD score was lower than that of the control groups A and B (p&lt;0.05); In the vascular endothelial function section, after the course of treatment, the serum","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Neurology, Affiliated Hospital of Beihua University, Jilin, 132011, China.'}, {'ForeName': 'Wenping', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of General Practice, Shanghai Songjiang District Central Hospital, Shanghai, 201600, China.'}]","Cellular and molecular biology (Noisy-le-Grand, France)",[]
2397,33040780,"Investigating the changes in the levels of HbA1c, blood fat and insulin sensitivity in elder patients with type II diabetes mellitus due to combined medication of pioglitazone and melbine and single-use of pioglitazone.","This study was founded for the purpose investigate the differences in effects of combined medication of pioglitazone and melbine and single-use of pioglitazone on the levels of hba1c, blood fat and insulin sensitivity of elder patients with type II diabetes mellitus (T2DM), to provide clinical reference and guidance for the treatment of T2DM in elder patients. For this purpose, we selected a total of 120 elder patients with T2DM who visited the clinic or were admitted to this hospital between July 2016 and July 2017 and divided them into the observation group and the control group (n=60 for each group). For the control group, they only took pioglitazone for treatment, while those in the observation additionally took melbine for treatment. Then, we observed the levels of FPG, 2hPG, HbA1c, blood fat, FINS, 2hINS and HOMA-IR. Results showed that after treatment, significant decreases were seen in levels of FPG, 2hPG and HbA1c in patients of two groups compared to the levels before treatment, and the levels in the observation group decreased more evidently than those in the control group (p&lt;0.05); besides, the levels of total glyceride, total cholesterol and LDL-C were all significantly lower than those before treatment, with an elevated HDL-C, and those levels of TG, TC and LDL-C in the observation group were significantly lower than those in the control group; the level of HDL-C was higher than the control group (p&lt;0.05). Similar decreases were identified in the levels of FINS, 2hFINS and HOMA-IR after treatment (p&lt;0.05), and the levels in the observation group were also significantly lower than those in the control group (p&lt;0.05). In the observation group, the incidence rate of adverse reactions was 10% (6/60), while in the control group was 8.33% (5/60), but the difference between the two groups showed no statistical significance (p&gt;0.05). It is concluded that combined medication of pioglitazone and melbine can effectively reduce the levels of plasma glucose, blood fat and the HOMA-IR, with an elevated sensitivity to insulin, but no severe adverse reactions, manifesting a promising safety in long-term administration. It is worthy of being promoted in clinical practice.",2020,"Results showed that after treatment, significant decreases were seen in levels of FPG, 2hPG and HbA1c in patients of two groups compared to the levels before treatment, and the levels in the observation group decreased more evidently than those in the control group (p&lt;0.05); besides, the levels of total glyceride, total cholesterol and LDL-C were all significantly lower than those before treatment, with an elevated HDL-C, and those levels of TG, TC and LDL-C in the observation group were significantly lower than those in the control group; the level of HDL-C was higher than the control group (p&lt;0.05).","['elder patients with type II diabetes mellitus', 'elder patients with type II diabetes mellitus (T2DM', '120 elder patients with T2DM who visited the clinic or were admitted to this hospital between July 2016 and July 2017 and divided them into the observation group and the control group (n=60 for each group', 'elder patients']","['pioglitazone and melbine and single-use of pioglitazone', 'pioglitazone']","['levels of FPG, 2hPG, HbA1c, blood fat, FINS, 2hINS and HOMA-IR', 'levels of hba1c, blood fat and insulin sensitivity', 'level of HDL-C', 'incidence rate of adverse reactions', 'levels of FINS, 2hFINS and HOMA-IR', 'levels of plasma glucose, blood fat and the HOMA-IR', 'levels of total glyceride, total cholesterol and LDL-C', 'levels of FPG, 2hPG and HbA1c', 'levels of HbA1c, blood fat and insulin sensitivity', 'levels of TG, TC and LDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017860', 'cui_str': 'Acylglycerols'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",120.0,0.0143385,"Results showed that after treatment, significant decreases were seen in levels of FPG, 2hPG and HbA1c in patients of two groups compared to the levels before treatment, and the levels in the observation group decreased more evidently than those in the control group (p&lt;0.05); besides, the levels of total glyceride, total cholesterol and LDL-C were all significantly lower than those before treatment, with an elevated HDL-C, and those levels of TG, TC and LDL-C in the observation group were significantly lower than those in the control group; the level of HDL-C was higher than the control group (p&lt;0.05).","[{'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of General Medicine, Hefei Hospital Affiliated to Anhui Medical University/The No.2 People's Hospital of Hefei，Hefei，Anhui230011，China.""}, {'ForeName': 'Qigui', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': ""Department of General Medicine, Hefei Hospital Affiliated to Anhui Medical University/The No.2 People's Hospital of Hefei，Hefei，Anhui230011，China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ""Department of General Medicine, Hefei Hospital Affiliated to Anhui Medical University/The No.2 People's Hospital of Hefei，Hefei，Anhui230011，China.""}]","Cellular and molecular biology (Noisy-le-Grand, France)",[]
2398,33040782,"Tuling Wendan Decoction combined with flunarizine in the treatment of migraine patients and the effect of intervention on serum cyclooxygenase-2, endothelin-1 and nitric oxide.","This experiment aimed to explore the curative effect of Tuling Wendan Decoction combined with flunarizine on migraine patients and the intervention effect on serum cyclooxygenase-2 (COX-2), endothelin-1 (ET-1), nitric oxide(NO) levels. For this purpose, from January 2019 to January 2020, 96 patients with migraine in our hospital were selected as the research object. Using a simple randomization method, patients who meet the criteria were assigned 1:1, and each patient was assigned a random number, of which the number 1 to 48 were the observation group, and the number 49 to 96 were the control group. The control group was treated with flunarizine, and the observation group was treated with Tuling Wendan Decoction combined with flunarizine. Comparing the efficacy, incidence of adverse reactions, the incidence of headache, cerebral blood flow rate [basal artery (BA), vertebral artery (VA), middle cerebral artery (MCA)], vascular endothelial function (serum COX-2, ET-1, NO levels), neurological function [5-hydroxytryptamine (5-HT), brain-derived neurotrophic factor (BDNF), calcitonin gene-related peptide (CGRP)] before treatment, 4 weeks and 8 weeks after treatment between the two groups. The results for efficacy showed that after 8 weeks of treatment, the total effective rate of the observation group (93.75%) was higher than that of the control group (77.08%, P&lt;0.05). In regards to the situation of headache attack, the number of headache attacks, duration, pain degree and accompanying symptom scores of the observation group after 4 weeks and 8 weeks of treatment were lower than those of the control group (P&lt;0.05). Results of cerebral blood flow velocity showed that the blood flow velocity of BA, VA, MCA in the observation group was lower than that in the control group after 4 and 8 weeks of treatment (P&lt;0.05). Vascular endothelial function results indicated that the serum COX-2 and ET-1 levels of the observation group were lower than those of the control group after 4 weeks and 8 weeks of treatment, and the serum NO levels were higher than that of the control group (P&lt;0.05). The serum BDNF and CGRP levels of the observation group were lower than those of the control group after 4 weeks and 8 weeks of treatment, and the serum 5-HT levels were higher than the control group (P&lt;0.05). The incidence of adverse reactions between the two groups was not statistically significant (P&gt;0.05). It was concluded that Tuling Wendan Decoction combined with flunarizine is the first treatment for migraine, with definite curative effect and can effectively improve the onset of headache, reduce the speed of cerebral blood flow, regulate vascular endothelial function and nerve function, and ensure safety.",2020,"The serum BDNF and CGRP levels of the observation group were lower than those of the control group after 4 weeks and 8 weeks of treatment, and the serum 5-HT levels were higher than the control group (P&lt;0.05).","['from January 2019 to January 2020, 96 patients with migraine in our hospital were selected as the research object', 'migraine patients']","['Tuling Wendan Decoction combined with flunarizine', 'flunarizine']","['blood flow velocity of BA, VA, MCA', 'speed of cerebral blood flow, regulate vascular endothelial function and nerve function, and ensure safety', 'total effective rate', 'efficacy, incidence of adverse reactions, the incidence of headache, cerebral blood flow rate [basal artery (BA), vertebral artery (VA), middle cerebral artery (MCA)], vascular endothelial function (serum COX-2, ET-1, NO levels), neurological function [5-hydroxytryptamine (5-HT), brain-derived neurotrophic factor (BDNF), calcitonin gene-related peptide (CGRP', 'serum BDNF and CGRP levels', 'serum cyclooxygenase-2, endothelin-1 and nitric oxide', 'serum 5-HT levels', 'incidence of adverse reactions', 'serum COX-2 and ET-1 levels', 'serum cyclooxygenase-2 (COX-2), endothelin-1 (ET-1), nitric oxide(NO) levels', 'number of headache attacks, duration, pain degree and accompanying symptom scores', 'serum NO levels', 'cerebral blood flow velocity', 'Vascular endothelial function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}]","[{'cui': 'C2353275', 'cui_str': 'wendan'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0016295', 'cui_str': 'Flunarizine'}]","[{'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0042559', 'cui_str': 'Structure of vertebral artery'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0387583', 'cui_str': 'Cyclooxygenase 2'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C1531810', 'cui_str': 'Calcitonin gene-related peptide level'}, {'cui': 'C0030015', 'cui_str': 'Oxides'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",96.0,0.0169706,"The serum BDNF and CGRP levels of the observation group were lower than those of the control group after 4 weeks and 8 weeks of treatment, and the serum 5-HT levels were higher than the control group (P&lt;0.05).","[{'ForeName': 'Xiayang', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': ""Department of traditional Chinese Medicine, Lianshui county people's Hospital, Huai'an, 223400, China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Shang', 'Affiliation': 'Department of Rehabilitation, Xuzhou Central Hospital, XuZhou, 221000, China.'}, {'ForeName': 'Xuejing', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Rehabilitation Medicine, The Affiliated Huai'an Hospital of Xuzhou Medical University and The Second People's Hospital of Huai'an, Huai'an, 223002, China.""}]","Cellular and molecular biology (Noisy-le-Grand, France)",[]
2399,33040806,The combination therapy with esomeprazole and flupenthixol/melitracen in symptom improvement of erosive gastritis complicated with negative feelings compared with Esomeprazole alone.,"The purpose of this study was to evaluate the co-prescription efficacy of esomeprazole and flupenthixol/melitracen relative to that of solitary esomeprazole on erosive gastritis complicated with negative feelings. 140 erosive gastritis patients complicated with negative feelings enrolled in the present study. Seventy cases in the control group took esomeprazole, and 70 cases in the observation group received esomeprazole plus flupenthixol/Melitracen, both for 4 weeks. We gastroscopically checked the clinical symptoms, mucosal erosion, PGE2 and MDA levels in gastric mucosa, anxiety, depression, and recurrence before and after treatment in the groups. After treatment, the observation group had lower scores of clinical symptoms, mucosal erosions, Hamilton Depression Rating Scale (HAMD), and Hamilton Depression Rating Scale (HAMA) than the control group (p&lt;0.05); as well, the observation group showed higher PGE2 and lower MDA levels than the control group (p&lt;0.05); during six months of follow-up (100% follow-up rate), 16 and 34 recurrent cases occurred, respectively, in the observation and control groups (p&lt;0.05).  Co-prescription of esomeprazole and flupenthixol/melitracen improved the clinical symptoms and mucosal erosions, relieved negative feelings and reduced the recurrence rate. The efficacy of the co-prescription is higher than that of the solitary prescription.",2020,"After treatment, the observation group had lower scores of clinical symptoms, mucosal erosions, Hamilton Depression Rating Scale (HAMD), and Hamilton Depression Rating Scale (HAMA) than the control group (p&lt;0.05); as well, the observation group showed higher PGE2 and lower MDA levels than the control group (p&lt;0.05); during six months of follow-up (100% follow-up rate), 16 and 34 recurrent cases occurred, respectively, in the observation and control groups (p&lt;0.05).  ","['erosive gastritis complicated with negative feelings', '140 erosive gastritis patients complicated with negative feelings enrolled in the present study']","['Esomeprazole', 'solitary esomeprazole', 'esomeprazole', 'esomeprazole and flupenthixol/melitracen', 'esomeprazole plus flupenthixol/Melitracen']","['PGE2 and lower MDA levels', 'clinical symptoms, mucosal erosion, PGE2 and MDA levels in gastric mucosa, anxiety, depression, and recurrence', 'clinical symptoms and mucosal erosions, relieved negative feelings', 'recurrence rate', 'lower scores of clinical symptoms, mucosal erosions, Hamilton Depression Rating Scale (HAMD), and Hamilton Depression Rating Scale (HAMA']","[{'cui': 'C0267112', 'cui_str': 'Acute gastric mucosal erosion'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0016367', 'cui_str': 'Flupenthixol'}, {'cui': 'C1377670', 'cui_str': 'MELITRACEN'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0546343', 'cui_str': 'Mucosal erosion'}, {'cui': 'C0017136', 'cui_str': 'Gastric mucous membrane structure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",140.0,0.0185218,"After treatment, the observation group had lower scores of clinical symptoms, mucosal erosions, Hamilton Depression Rating Scale (HAMD), and Hamilton Depression Rating Scale (HAMA) than the control group (p&lt;0.05); as well, the observation group showed higher PGE2 and lower MDA levels than the control group (p&lt;0.05); during six months of follow-up (100% follow-up rate), 16 and 34 recurrent cases occurred, respectively, in the observation and control groups (p&lt;0.05).  ","[{'ForeName': 'Lidan', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': '1. General Medicine Ward, Gele Mountain Hospital of Chongqing Mental Health Center, Chongqing,400036, China.'}, {'ForeName': 'Liandong', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': ""Department of anus & intestine surgery, Affiliated Hospital of Yan'an University, Yan'an, Shanxi, China.""}, {'ForeName': 'Dechuan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': '3. Department of general surgery, Central Hospital of Chongqing Three Gorges, Bai an Branch, Chongqing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of general practice, Central Hospital of Chongqing Three Gorges, Bai an Branch, Chongqing, China.'}, {'ForeName': 'Xingpeng', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of anaesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Shengquan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""Department of general surgery, Guanvun County People's Hospital of Jiangsu Province, Lianyungang, Jiangsu, China.""}]","Cellular and molecular biology (Noisy-le-Grand, France)",[]
2400,32861830,Improving uptake of hepatitis B and hepatitis C testing in South Asian migrants in community and faith settings using educational interventions-A prospective descriptive study.,"BACKGROUND


Chronic viral hepatitis (CVH) is a leading contributor to the UK liver disease epidemic, with global migration from high prevalence areas (e.g., South Asia). Despite international guidance for testing high-risk groups in line with elimination targets, there is no consensus on how to achieve this. The objectives of this study were to assess the following: (1) the feasibility of recruiting South Asian migrants to view an educational film on CVH, (2) the effectiveness of the film in promoting testing and increasing knowledge of CVH, and (3) the methodological issues relevant to scale-up to a randomized controlled trial.
METHODS


South Asian migrants were recruited to view the film (intervention) in community venues (primary care, religious, community), with dried blood spot CVH testing offered immediately afterwards. Pre/post-film questionnaires assessed the effectiveness of the intervention.
RESULTS


Two hundred and nineteen first-generation migrants ≥18 years of age (53% female) were recruited to view the film at the following sites: religious, n = 112 (51%), community n = 98 (45%), and primary care, n = 9 (4%). One hundred and eighty-four (84%) underwent CVH testing; hepatitis B core antibody or hepatitis C antibody positivity demonstrated exposure in 8.5%. Pre-intervention (n = 173, 79%) and post-intervention (n = 154, 70%) questionnaires were completed.
CONCLUSIONS


This study demonstrated the feasibility of recruiting first-generation migrants to view a community-based educational film promoting CVH testing in this higher risk group, confirming the value of developing interventions to facilitate the global World Health Organization plan for targeted case finding and elimination, and a future randomized controlled trial. We highlight the importance of culturally relevant interventions including faith and culturally sensitive settings, which appear to minimize logistical issues and effectively engage minority groups, allowing ease of access to individuals 'at risk'.",2020,"Pre-intervention (n = 173, 79%) and post-intervention (n = 154, 70%) questionnaires were completed.
","['Chronic viral hepatitis (CVH', 'South Asian migrants were recruited to view the film (intervention) in community venues (primary care, religious, community), with', 'Two hundred and nineteen first-generation migrants ≥18 years of age (53% female']","['hepatitis B and hepatitis C testing', 'dried blood spot CVH testing offered immediately afterwards', 'CVH testing']",[],"[{'cui': 'C0276623', 'cui_str': 'Chronic viral hepatitis'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0026093', 'cui_str': 'Migrant'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C2711110', 'cui_str': 'Hepatitis B and hepatitis C'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0276623', 'cui_str': 'Chronic viral hepatitis'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205548', 'cui_str': 'Stat'}]",[],,0.0395415,"Pre-intervention (n = 173, 79%) and post-intervention (n = 154, 70%) questionnaires were completed.
","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Department of Gastroenterology and Hepatology, Royal Surrey NHS Foundation Trust, Guildford, Surrey, UK; Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Marinos', 'Initials': 'M', 'LastName': 'Pericleous', 'Affiliation': 'Department of Gastroenterology and Hepatology, Royal Surrey NHS Foundation Trust, Guildford, Surrey, UK; Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Brunel Business School, Brunel University, London, UK.'}, {'ForeName': 'Tushna', 'Initials': 'T', 'LastName': 'Vandrevala', 'Affiliation': 'Department of Psychology, Kingston University, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Hendy', 'Affiliation': 'Brunel Business School, Brunel University, London, UK.'}, {'ForeName': 'Shuja', 'Initials': 'S', 'LastName': 'Shafi', 'Affiliation': 'Research and Documentation Committee, The Muslim Council of Britain, London, UK.'}, {'ForeName': 'Simon S', 'Initials': 'SS', 'LastName': 'Skene', 'Affiliation': 'Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Sumita', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Department of Clinical and Experimental Medicine, Brighton and Sussex Medical School and Department of Gastroenterology and Hepatology, Brighton and Sussex University Hospital, Brighton, UK.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Edge', 'Affiliation': 'Institute of Epidemiology and Health Care, UCL, London, UK.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Nicholls', 'Affiliation': 'Public Health England South East, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Gore', 'Affiliation': 'The Hepatitis C Trust, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'de Lusignan', 'Affiliation': 'Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Royal College of General Practitioners Research and Surveillance Centre, London, UK.'}, {'ForeName': 'Aftab', 'Initials': 'A', 'LastName': 'Ala', 'Affiliation': 'Department of Gastroenterology and Hepatology, Royal Surrey NHS Foundation Trust, Guildford, Surrey, UK; Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK. Electronic address: aftab.ala1@nhs.net.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.08.059']
2401,32881622,Essential amino acid supplementation alters the p53 transcriptional response and cytokine gene expression following total knee arthroplasty.,"Reducing muscle atrophy following orthopedic surgery is critical during the postoperative period. Our previous work in patients who underwent total knee arthroplasty (TKA) showed that the vast majority of atrophy occurs within 2 wk following surgery and that essential amino acid (EAA) supplementation attenuates this atrophy. We used RNA-sequencing (RNA-seq) to identify genes associated with atrophy after TKA with and without EAAs. Analysis of overrepresented gene-ontology terms revealed that p53 signaling and the cytokine-cytokine receptor pathways were highly upregulated after TKA. Relative to the placebo group, the EAA group had altered expression of p53 regulators such as  MDM2 . This altered expression may account for differences between groups in timing of upregulation of some p53 targets such as apoptosis genes, and may account for the reduction in muscle loss in the subjects receiving EAAs. Furthermore, we observed altered expression of a large number of cytokine-signaling genes including  TNFRSF12A , which plays a critical role in muscle atrophy, myogenesis, fibrosis, and the noncanonical NF-κB pathway. NEW & NOTEWORTHY  Total knee arthroplasty is the most frequently performed inpatient surgical procedure for those over 45 yr in the United States. Following surgery, patients lose a large amount of muscle, which impacts functional mobility. Previously, our laboratory found that supplementing patients' diets with essential amino acids (EAAs) reduces postsurgical muscle loss. Here, our goal was to characterize the transcriptional changes associated with surgery with and without EAA supplementation to uncover the underlying mechanisms by which EAAs attenuate this muscle loss.",2020,"Relative to the placebo group, the EAA group had altered expression of p53 regulators such as  MDM2 .","['Total knee arthroplasty is the most frequently performed inpatient surgical procedure for those over 45 yr in the United States', 'patients who underwent total knee arthroplasty (TKA', 'total knee arthroplasty']","['EAA', 'placebo', 'essential amino acid (EAA) supplementation', 'Essential amino acid supplementation', 'essential amino acids (EAAs']","['p53 transcriptional response and cytokine gene expression', 'altered expression of p53 regulators such as  MDM2 ', 'p53 signaling and the cytokine-cytokine receptor pathways']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0556083', 'cui_str': 'Essential amino acid supplementation'}]","[{'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0971008', 'cui_str': 'MDM2 protein, human'}, {'cui': 'C0206552', 'cui_str': 'Cytokine Receptor'}]",,0.0540947,"Relative to the placebo group, the EAA group had altered expression of p53 regulators such as  MDM2 .","[{'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Muyskens', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Winbush', 'Affiliation': 'Institute of Ecology and Evolution, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Foote', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Turnbull', 'Affiliation': 'Genomics and Cell Characterization Core Facility, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Hans C', 'Initials': 'HC', 'LastName': 'Dreyer', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00022.2020']
2402,33044837,The effects of video based nursing education on perioperative anxiety and depression in patients with gastric cancer.,"The purpose of this study was to determine the effect of video-based nursing education on perioperative anxiety and depression. A total of 128 patients scheduled for minimally invasive gastrectomy were randomly divided into intervention ( n  = 64) and control (n = 64) group. The. The anxiety and depression scores, systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR) were assessed before the intervention, 1 h before surgery and 24 h after surgery. And the cortisol levels were measured before the intervention and 1 h before surgery. No significant difference was observed in baseline anxiety score, depression score, vital signs and cortisol level ( P  > 0.05). The anxiety level, depression level, SBP, DBP and HR of patients in intervention group was significantly lower than that in control group at 1 h before surgery and 24 hs after surgery ( P  < 0.05). The serum cortisol in the intervention group was also significantly lower than that in the control group 1 h before surgery (p < 0.001). Video-based nursing education was effective in decreasing the perioperative anxiety and depression of patients undergoing minimally invasive gastrectomy. It could also keep vital signs and serum cortisol levels in normal limits.",2020,"The anxiety level, depression level, SBP, DBP and HR of patients in intervention group was significantly lower than that in control group at 1 h before surgery and 24 hs after surgery ( P  < 0.05).","['patients undergoing minimally invasive gastrectomy', 'patients with gastric cancer', '128 patients scheduled for minimally invasive gastrectomy']","['Video-based nursing education', 'video based nursing education', 'video-based nursing education']","['perioperative anxiety and depression', 'serum cortisol', 'anxiety level, depression level, SBP, DBP and HR', 'cortisol levels', 'anxiety and depression scores, systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR', 'baseline anxiety score, depression score, vital signs and cortisol level', 'vital signs and serum cortisol levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013636', 'cui_str': 'Nursing Education'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}]",128.0,0.0157588,"The anxiety level, depression level, SBP, DBP and HR of patients in intervention group was significantly lower than that in control group at 1 h before surgery and 24 hs after surgery ( P  < 0.05).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Nursing, The Affiliated Haian Hospital of Nantong University , Nantong, Jiangsu Province, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Surgery, The Affiliated Haian Hospital of Nantong University , Nantong, Jiangsu Province, China.'}, {'ForeName': 'Yajuan', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Nursing, The Affiliated Haian Hospital of Nantong University , Nantong, Jiangsu Province, China.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Department of Nursing, The Affiliated Haian Hospital of Nantong University , Nantong, Jiangsu Province, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Ge', 'Affiliation': 'Department of Nursing, The Affiliated Haian Hospital of Nantong University , Nantong, Jiangsu Province, China.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Chu', 'Affiliation': 'Department of Nursing, The Affiliated Haian Hospital of Nantong University , Nantong, Jiangsu Province, China.'}, {'ForeName': 'Chunxiang', 'Initials': 'C', 'LastName': 'Xia', 'Affiliation': 'Department of Nursing, The Affiliated Haian Hospital of Nantong University , Nantong, Jiangsu Province, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Nursing, The Affiliated Haian Hospital of Nantong University , Nantong, Jiangsu Province, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, The Affiliated Haian Hospital of Nantong University , Nantong, Jiangsu Province, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Department of Nursing, The Affiliated Haian Hospital of Nantong University , Nantong, Jiangsu Province, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, The Second Hospital of Nanjing , Nanjing, Jiangsu, Province, China.'}]","Psychology, health & medicine",['10.1080/13548506.2020.1825756']
2403,33044838,A Biomechanical Comparison of 2 Hip Capsular Reconstruction Techniques: Iliotibial Band Autograft Versus Achilles Tendon Allograft.,"BACKGROUND


Several techniques for hip capsular reconstruction have been described to address gross instability or microinstability due to capsular deficiency. However, objective biomechanical data to support their use are lacking.
PURPOSE


To compare the kinematic effect of 2 capsular reconstruction techniques (iliotibial band [ITB] graft and Achilles tendon graft). Kinematic effect encompassed rotational range of motion (ROM) as well as joint translation in the coronal, sagittal, and axial planes.
STUDY DESIGN


Controlled laboratory study.
METHODS


8 paired, fresh-frozen hemi-pelvises (16 hips) were tested on a custom-designed joint motion simulator in the intact state and after capsulectomy. Pairs were randomly allocated to either ITB or Achilles reconstruction and retested. Testing was performed at 0°, 45°, and 90° of flexion. Internal-external rotation (IR-ER) torques and abduction-adduction torques of 3 N·m were applied to the femur via a load cell at each position, and rotational ROM and joint translation in the coronal, sagittal, and axial planes were recorded.
RESULTS


At 45° and 90°, there was a significant effect of the condition of the hip on the total IR-ER ( P  = .004, effect size [ES] = 0.305; and  P  < .001, ES = 0.497; respectively). At 45°, mean ± SD total rotation was significantly greater for the capsulectomy (59.7°± 15.9°) state compared with intact (53.3°± 13.2°;  P  = .007). At 90°, reconstruction significantly decreased total rotation to 49.0°± 18.9° compared with a mean total rotation of 52.8°± 18.7° after capsulectomy ( P  = .02). No difference was seen in the total abduction-adduction of the hip between conditions. Comparisons of the 2 different reconstruction techniques showed no significant differences in total IR-ER or abduction-adduction ROM or joint translation in the coronal, sagittal, or axial planes. For translation, at both 0° and 45° there was a statistically significant effect of the condition on the medial-lateral translation ( P  = .033; ES = 0.204). Reconstruction, independent of technique, was successful in significantly decreasing ( P  = .030;  P  = .014) the mean medial-lateral translation at 0° and 45° of hip flexion from 5.2 ± 3.8 mm and 5.6 ± 4.0 mm to 2.8 ± 1.9 mm and 3.9 ± 3.2 mm, respectively.
CONCLUSION


The integrity of the native hip capsule played a significant role in rotational stability, where capsulectomy significantly increased rotational ROM. Both ITB and Achilles reconstruction techniques restored normal rotational ROM of the hip at 90° of flexion as well as coronal plane stability at 0° and 45° of hip flexion. No differences were seen between ITB and Achilles reconstruction techniques.
CLINICAL RELEVANCE


Both capsular reconstruction techniques provide comparable joint kinematics, restoring rotation and translation to normal values with the exception of rotational ROM at 45°, which remained significantly greater than the intact state. The most significant results were the rotational stability at 90° of hip flexion and coronal plane stability at 0° and 45° of hip flexion, which were significantly improved compared with the capsulectomy state.",2020,"Comparisons of the 2 different reconstruction techniques showed no significant differences in total IR-ER or abduction-adduction ROM or joint translation in the coronal, sagittal, or axial planes.","['8 paired, fresh-frozen hemi-pelvises (16 hips', '2 Hip Capsular Reconstruction Techniques']","['2 capsular reconstruction techniques (iliotibial band [ITB] graft and Achilles tendon graft', 'ITB or Achilles reconstruction', 'Iliotibial Band Autograft Versus Achilles Tendon Allograft', 'custom-designed joint motion simulator']","['Internal-external rotation (IR-ER) torques and abduction-adduction torques', 'total IR-ER or abduction-adduction ROM or joint translation in the coronal, sagittal, or axial planes', 'rotational range of motion (ROM', 'total rotation', 'normal rotational ROM', 'medial-lateral translation', 'mean ± SD total rotation', 'rotational stability at 90° of hip flexion and coronal plane stability', 'total abduction-adduction', 'coronal plane stability', 'joint kinematics, restoring rotation and translation to normal values', 'rotational ROM', 'mean medial-lateral translation', 'condition of the hip on the total IR-ER', 'rotational stability']","[{'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0225266', 'cui_str': 'Structure of iliotibial tract'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C4551585', 'cui_str': 'Coronal plane'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0086715', 'cui_str': 'Normal range'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.0301196,"Comparisons of the 2 different reconstruction techniques showed no significant differences in total IR-ER or abduction-adduction ROM or joint translation in the coronal, sagittal, or axial planes.","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Pasic', 'Affiliation': 'Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Burkhart', 'Affiliation': 'Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Pardis', 'Initials': 'P', 'LastName': 'Baha', 'Affiliation': 'School of Kinesiology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Olufemi R', 'Initials': 'OR', 'LastName': 'Ayeni', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University Medical Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Getgood', 'Affiliation': 'Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Degen', 'Affiliation': 'Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}]",The American journal of sports medicine,['10.1177/0363546520962071']
2404,33044849,"The effect of two concurrent exercise modalities on serum concentrations of FGF21, irisin, follistatin, and myostatin in men with type 2 diabetes mellitus.","This study investigated the effect of concurrent training (CT) sequences on fibroblast growth factor 21 (FGF21), irisin, myostatin (MSTN), and follistatin (FST) among adults with type 2 diabetes mellitus (T2DM). Fifty-one diabetic men were randomly selected and assigned to concurrent aerobic-resistance (A-R) training and concurrent resistance-aerobic (R-A) training, and non-exercise control (CON) groups. The training protocols consisted of three sessions per week for 12 weeks. The A-R and R-A groups received the same CT protocols and performed with different sequences. The subjects' blood samples were obtained at baseline and 48 hours after the last session of the intervention. The results showed that the concentration of FGF21 did not change significantly after the 12 weeks of CT with different sequences ( p  > .05,  η   2  = 0.123), but the serum concentration of irisin (A-R = 2.93 μg.L -1  (95% CI = 1.45-4.42,  d  = -0.57) and R-A = 3.31 μg.L -1  (95% CI = 1.13-5.49,  d  = -0.68)) and FST (A-R = 4.96 ng.mL -1  (95% CI = 3.41-6.5,  d  = -0.39) and R-A = 4.19 ng.mL -1  (95% CI = 2.82-5.56,  d  = -0.55)) significantly increased while the serum MSTN concentration (A-R = 152.32 ng.L -1  (95% CI = 61.83-242.82,  d  = 1.31) and R-A = 173 ng.L -1  (95% CI = 35.89-227.5,  d  = 0.83)) of both A-R and R-A groups mainly decreased ( p  < .01). There was no significant difference between A-R and R-A groups' irisin, FST, and MSTN concentration ( p  > .05), though the CT improved the body compositions, strength, and peak oxygen uptake in both groups ( p  < .01). Regardless of the CT sequences, it was found that CT acted as a therapeutic modality of training for T2DM patients by increasing their irisin and FST and decreasing their MSTN concentrations.",2020,"There was no significant difference between A-R and R-A groups' irisin, FST, and MSTN concentration ( p  > .05), though the CT improved the body compositions, strength, and peak oxygen uptake in both groups ( p  < .01).","['Fifty-one diabetic men', 'adults with type 2 diabetes mellitus (T2DM', 'men with type 2 diabetes mellitus']","['concurrent aerobic-resistance (A-R) training and concurrent resistance-aerobic (R-A) training, and non-exercise control (CON', 'concurrent exercise modalities', 'concurrent training (CT) sequences', 'CT']","['serum MSTN concentration', 'concentration of FGF21', 'serum concentration of irisin', 'irisin, FST, and MSTN concentration', 'fibroblast growth factor 21 (FGF21), irisin, myostatin (MSTN), and follistatin (FST', 'body compositions, strength, and peak oxygen uptake', 'serum concentrations of FGF21, irisin, follistatin, and myostatin', 'FST']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0060623', 'cui_str': 'Activin-Binding Protein'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",51.0,0.0324171,"There was no significant difference between A-R and R-A groups' irisin, FST, and MSTN concentration ( p  > .05), though the CT improved the body compositions, strength, and peak oxygen uptake in both groups ( p  < .01).","[{'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Motahari Rad', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Bijeh', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Seyyed Reza', 'Initials': 'SR', 'LastName': 'Attarzadeh Hosseini', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Aliakbar', 'Initials': 'A', 'LastName': 'Raouf Saeb', 'Affiliation': 'Parsian Diabetes Clinic, Mashhad, Iran.'}]",Archives of physiology and biochemistry,['10.1080/13813455.2020.1829649']
2405,33044856,Pharmacodynamic and Pharmacokinetic Effects of a Low Maintenance Dose Ticagrelor Regimen Versus Standard Dose Clopidogrel in Diabetes Mellitus Patients Without Previous Major Cardiovascular Events Undergoing Elective Percutaneous Coronary Intervention: The OPTIMUS-6 Study.,,2020,,['Diabetes Mellitus Patients'],"['Low Maintenance Dose Ticagrelor Regimen Versus Standard Dose Clopidogrel', 'Elective Percutaneous Coronary Intervention']",[],"[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]",[],,0.0159364,,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Franchi', 'Affiliation': 'University of Florida College of Medicine-Jacksonville.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Rollini', 'Affiliation': 'University of Florida College of Medicine-Jacksonville.'}, {'ForeName': 'Latonya', 'Initials': 'L', 'LastName': 'Been', 'Affiliation': 'University of Florida College of Medicine-Jacksonville.'}, {'ForeName': 'Maryuri', 'Initials': 'M', 'LastName': 'Briceno', 'Affiliation': 'University of Florida College of Medicine-Jacksonville.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Maaliki', 'Affiliation': 'University of Florida College of Medicine-Jacksonville.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Wali', 'Affiliation': 'University of Florida College of Medicine-Jacksonville.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rivas', 'Affiliation': 'University of Florida College of Medicine-Jacksonville.'}, {'ForeName': 'Andres M', 'Initials': 'AM', 'LastName': 'Pineda', 'Affiliation': 'University of Florida College of Medicine-Jacksonville.'}, {'ForeName': 'Siva', 'Initials': 'S', 'LastName': 'Suryadevara', 'Affiliation': 'University of Florida College of Medicine-Jacksonville.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Soffer', 'Affiliation': 'University of Florida College of Medicine-Jacksonville.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Zenni', 'Affiliation': 'University of Florida College of Medicine-Jacksonville.'}, {'ForeName': 'Theodore A', 'Initials': 'TA', 'LastName': 'Bass', 'Affiliation': 'University of Florida College of Medicine-Jacksonville.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine-Jacksonville.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.048770']
2406,33045140,Double-blinded randomized prospective trial of intranasal capsaicin treatment for nonallergic rhinitis.,"BACKGROUND


Nonallergic rhinitis (NAR) is currently a diagnosis of exclusion with an unclear pathophysiologic mechanism and limited treatment options. In patients diagnosed with NAR based on symptoms, negative skin testing and positive optical rhinometry (ORM), the study's objective was to evaluate the therapeutic action of intranasal capsaicin in the management of rhinitic symptoms and the effect on ORM readings.
METHODS


Patients with a history of NAR underwent screening by a diagnostic intranasal capsaicin challenge with ORM and skin-prick testing. Twenty-two NAR patients were enrolled and randomized to either treatment with 0.1mM capsaicin (n = 11) or placebo (n = 11). Treatment consisted of 5 consecutive intranasal applications separated by 1 hour with follow-up at 4 and 12 weeks. At each visit, subjects underwent intranasal capsaicin challenge with ORM reading and a visual analog scale scoring of rhinitis symptoms.
RESULTS


Treatment with intranasal capsaicin resulted in a median change with improvement in total symptom score (TSS) of -5 from baseline vs an increase of 2 with placebo at 4 weeks, which remained significantly different between the groups at 12 weeks (p = 0.03). At 12 weeks posttreatment, 60% of the intervention group vs 80% of placebo-treated patients still met objective criteria for NAR by ORM.
CONCLUSION


Using ORM in the objective diagnosis of NAR, this trial showed that intranasal 0.1mM capsaicin not only improved rhinitic symptoms but also objectively reduced nasal reactivity and nasal congestion with a 40% responder rate at 12 weeks as noted by ORM.",2020,"At 12 weeks posttreatment, 60% of the intervention group vs 80% of placebo-treated patients still met objective criteria for NAR by ORM.
","['Twenty-two NAR patients', 'patients diagnosed with NAR based on symptoms, negative skin testing and positive optical rhinometry (ORM', 'Patients with a history of NAR underwent screening by a diagnostic intranasal capsaicin challenge with ORM and skin-prick testing', 'Nonallergic rhinitis (NAR', 'nonallergic rhinitis']","['0.1mM capsaicin', 'intranasal capsaicin', 'placebo']","['total symptom score (TSS', 'rhinitic symptoms', 'nasal reactivity and nasal congestion']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0037296', 'cui_str': 'Hypersensitivity skin testing'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}]","[{'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}]",22.0,0.301178,"At 12 weeks posttreatment, 60% of the intervention group vs 80% of placebo-treated patients still met objective criteria for NAR by ORM.
","[{'ForeName': 'Denna', 'Initials': 'D', 'LastName': 'Zebda', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School at the University of Texas Health Science Center, Houston, TX.'}, {'ForeName': 'Zi Yang', 'Initials': 'ZY', 'LastName': 'Jiang', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School at the University of Texas Health Science Center, Houston, TX.'}, {'ForeName': 'Micah M', 'Initials': 'MM', 'LastName': 'Gibson', 'Affiliation': 'Department of Otolaryngology, Emory University, Atlanta, GA.'}, {'ForeName': 'Chauchau', 'Initials': 'C', 'LastName': 'Pham', 'Affiliation': 'Ear Nose and Throat Associates, Fort Myers, FL.'}, {'ForeName': 'Sorour', 'Initials': 'S', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School at the University of Texas Health Science Center, Houston, TX.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Floren', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School at the University of Texas Health Science Center, Houston, TX.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Yao', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School at the University of Texas Health Science Center, Houston, TX.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Citardi', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School at the University of Texas Health Science Center, Houston, TX.'}, {'ForeName': 'Amber U', 'Initials': 'AU', 'LastName': 'Luong', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School at the University of Texas Health Science Center, Houston, TX.'}]",International forum of allergy & rhinology,['10.1002/alr.22637']
2407,33045193,Home-based oral self-testing for absent and declining individuals during a door-to-door HIV testing campaign in rural Lesotho (HOSENG): a cluster-randomised trial.,"BACKGROUND


In sub-Saharan Africa, home-based HIV testing is validated and accepted, but coverage is low because household members are often absent during home-based testing campaigns. We aimed to measure the effect of a secondary distribution of oral-fluid HIV self-tests on coverage during home-based testing in rural Lesotho.
METHODS


The Home-Based Self-Testing (HOSENG) trial was a cluster-randomised, non-blinded superiority trial in rural villages in the catchment area of 20 health facilities of two districts in Lesotho (Butha-Buthe and Mokhotlong). Eligible villages had a consenting village chief and at least one registered village health worker; eligible households had a consenting representative aged 18 years or older. The HOSENG trial provided a recruitment platform for the interlinked Village-Based Refill of Antiretroviral Therapy (VIBRA) trial. Villages were randomly assigned 1:1:1:1 with block sizes of four to one of four groups: VIBRA control and HOSENG control; VIBRA control and HOSENG intervention; VIBRA intervention and HOSENG control; and VIBRA intervention and HOSENG intervention. Randomisation was stratified by district, village size, and access to the nearest health facility. An independent statistician was responsible for the computer-generated randomisation list. In the intervention group, oral-fluid HIV self-tests were left for absent or declining household members (aged ≥12 years) during a home visit from the HIV testing campaign team. One present household member was trained on self-test use. Distributed self-tests were followed up by village health workers. In control village clusters, absent or declining household members were referred to the clinic for HIV testing. The primary outcome was HIV testing coverage among all household members aged 12 years or older within 120 days, defined as a confirmed HIV test result or known status, reported in testing registers at the health facilities or on the follow-up forms of the village health worker. Adjusted random-effects logistic regression with individuals as the unit of analysis was used. This trial is registered with ClinicalTrials.gov, NCT03598686.
FINDINGS


Between July 26, 2018, and Dec 12, 2018, 3091 consenting households with 7816 household members aged 12 years or older were enrolled and randomly assigned (intervention: 57 village clusters, 1620 households, 4174 household members; control: 49 village clusters, 1471 households, 3642 household members). In the control group, 38 (3%) of 1455 initially absent or declining household members tested at a clinic within 120 days. In the intervention group, 841 (53%) of 1601 initially absent or declining household members had a confirmed status within 120 days; 12 (1%) of 841 tested at the clinic and 829 (99%) used their self-test kit. This resulted in a testing coverage of 2201 (60%) of 3642 in the control group versus 3386 (81%) of 4174 in the intervention group (odds ratio 3·00 [95% CI 2·52-3·59]; p<0·0001).
INTERPRETATION


Secondary distribution of oral-fluid HIV self-tests during home-based testing increases testing coverage substantially and thus presents a promising add-on during testing campaigns.
FUNDING


Swiss National Science Foundation.",2020,"This resulted in a testing coverage of 2201 (60%) of 3642 in the control group versus 3386 (81%) of 4174 in the intervention group (odds ratio 3·00 [95% CI 2·52-3·59]; p<0·0001).
","['Between July 26, 2018, and Dec 12, 2018, 3091 consenting households with 7816 household members aged 12 years or older were enrolled and randomly assigned (intervention: 57 village clusters, 1620 households, 4174 household members; control: 49 village clusters, 1471 households, 3642 household members', 'rural villages in the catchment area of 20 health facilities of two districts in Lesotho (Butha-Buthe and Mokhotlong', 'rural Lesotho', 'Eligible villages had a consenting village chief and at least one registered village health worker; eligible households had a consenting representative aged 18 years or older']","['oral-fluid HIV self-tests', 'VIBRA control and HOSENG control; VIBRA control and HOSENG intervention; VIBRA intervention and HOSENG control; and VIBRA intervention and HOSENG intervention']",['HIV testing coverage'],"[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007403', 'cui_str': 'Health Catchment Area'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0023376', 'cui_str': 'Lesotho'}, {'cui': 'C0087157', 'cui_str': 'Village Health Worker'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0459958', 'cui_str': 'HIV screening'}]",,0.134167,"This resulted in a testing coverage of 2201 (60%) of 3642 in the control group versus 3386 (81%) of 4174 in the intervention group (odds ratio 3·00 [95% CI 2·52-3·59]; p<0·0001).
","[{'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Amstutz', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; Department of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Thabo Ishmael', 'Initials': 'TI', 'LastName': 'Lejone', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Lefu', 'Initials': 'L', 'LastName': 'Khesa', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Muhairwe', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Moniek', 'Initials': 'M', 'LastName': 'Bresser', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Vanobberghen', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Mathebe', 'Initials': 'M', 'LastName': 'Kopo', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Mpho', 'Initials': 'M', 'LastName': 'Kao', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Bienvenu Lengo', 'Initials': 'BL', 'LastName': 'Nsakala', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Katleho', 'Initials': 'K', 'LastName': 'Tlali', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Klimkait', 'Affiliation': 'University of Basel, Basel, Switzerland; Molecular Virology, Department of Biomedicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Battegay', 'Affiliation': 'Department of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Niklaus Daniel', 'Initials': 'ND', 'LastName': 'Labhardt', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; Department of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland. Electronic address: n.labhardt@swisstph.ch.'}, {'ForeName': 'Tracy Renée', 'Initials': 'TR', 'LastName': 'Glass', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30233-2']
2408,33045195,Circulating profile of Activin-Follistatin-Inhibin Axis in women with hypothalamic amenorrhea in response to leptin treatment.,"BACKGROUND


Chronic energy deficiency observed in women that exercise strenuously affects reproductive function, often leading to hypothalamic amenorrhea (HA). In such conditions, hypoleptinemia and robust changes in the Activin-Follistatin-Inhibin Axis (AFI) are observed. Treatment with leptin restores menstruation in many (60% responders) but not all (40% non-responders) women, suggesting that leptin is not the only regulator of reproductive function related to energy balance. In this work, we aimed to identify differences in hormonal profiles between leptin responders and non-responders among women with HA, with particular focus on the AFI axis.
METHODS


AFI axis and reproductive hormones (LH, FSH, Estradiol, ΑΜΗ) were measured in blood in: a) An open-label interventional study, b) a randomized placebo-controlled trial, both investigating responders versus non-responders/women with HA treated with leptin.
RESULTS


Women with HA that responded to leptin treatment have higher circulating levels/peak values of Inhibin A, Estradiol (E2), higher LH/FSH ratio and a trend to lower AMH compared with non-responders.
CONCLUSIONS


Components of the AFI axis are associated with improvement of reproductive function in women with HA treated with leptin. ΑΜΗ may serve as a marker of ovarian recovery under HA treatment.",2020,"Treatment with leptin restores menstruation in many (60% responders) but not all (40% non-responders) women, suggesting that leptin is not the only regulator of reproductive function related to energy balance.","['women with HA, with particular focus on the AFI axis', 'responders versus non-responders/women with HA treated with leptin', 'women with HA treated with leptin', 'women with hypothalamic amenorrhea in response to leptin treatment']",['placebo'],"['circulating levels/peak values of Inhibin A, Estradiol (E2), higher LH/FSH ratio', 'reproductive function', 'AFI axis and reproductive hormones (LH, FSH, Estradiol, ΑΜΗ']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0341862', 'cui_str': 'Hypothalamic amenorrhea'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0883157', 'cui_str': 'Inhibin A'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0232896', 'cui_str': 'Reproductive function'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C1167871', 'cui_str': 'Reproductive hormone'}]",,0.0378645,"Treatment with leptin restores menstruation in many (60% responders) but not all (40% non-responders) women, suggesting that leptin is not the only regulator of reproductive function related to energy balance.","[{'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Bouzoni', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA. Electronic address: ebouzoni@bidmc.harvard.edu.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Perakakis', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Mantzoros', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA; Section of Endocrinology, VA Boston Healthcare System, Jamaica Plain, MA, USA.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154392']
2409,33045216,"Randomized, double-masked trial of netarsudil 0.02% ophthalmic solution for prevention of corticosteroid-induced ocular hypertension.","PURPOSE


To assess whether prophylactic use of netarsudil 0.02% ophthalmic solution reduces the risk of intraocular pressure (IOP) elevation associated with prolonged use of topical corticosteroids to prevent cornea transplant rejection.
DESIGN


Prospective, randomized clinical trial METHODS: In this study, 120 subjects were randomized to use netarsudil (off-label) or placebo once daily for 9 months after Descemet membrane endothelial keratoplasty (DMEK), and 71 fellow eyes were enrolled and assigned to the opposite treatment arm. Participants concurrently used topical prednisolone acetate 1% 4-times daily for 3 months, 3-times daily for a month, twice daily for a month, and once daily for 4 months. The main outcome was IOP elevation (defined as IOP ≥ 24 mm Hg or an increase of ≥ 10 mm Hg over baseline) assessed by Kaplan-Meier and proportional hazards analyses, taking loss to follow up into consideration.
RESULTS


Overall, 95 eyes were assigned to netarsudil and 96 to placebo; 15 eyes (16%) withdrew early from the netarsudil arm because of ocular irritation. The rate of IOP elevation was 14% with netarsudil and 21% with placebo (relative risk = 0.6, 95% confidence interval: 0.3 to 1.3, p = 0.23). Intraocular pressure exceeded 30 mm Hg in 7.8% assigned to netarsudil vs. 7.4% assigned to placebo (p = 0.84). Median 6-month central endothelial cell loss was 31% vs. 29% with netarsudil vs. placebo, respectively (p = 0.49).
CONCLUSIONS


Netarsudil did not produce a statistically significant reduction in the risk of steroid-induced IOP elevation after corneal transplantation relative to placebo.",2020,Intraocular pressure exceeded 30 mm Hg in 7.8% assigned to netarsudil vs. 7.4% assigned to placebo (p = 0.84).,"['71 fellow eyes', '120 subjects']","['topical corticosteroids', 'netarsudil (off-label) or placebo', 'placebo', 'topical prednisolone acetate', 'netarsudil 0.02% ophthalmic solution']","['risk of intraocular pressure (IOP) elevation', 'rate of IOP elevation', 'ocular hypertension', 'Intraocular pressure', 'Median 6-month central endothelial cell loss', 'IOP elevation']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C4535718', 'cui_str': 'netarsudil'}, {'cui': 'C1096117', 'cui_str': 'Off label use'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071839', 'cui_str': 'Prednisolone acetate'}, {'cui': 'C4535722', 'cui_str': 'netarsudil 0.2 MG/ML Ophthalmic Solution'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}]",120.0,0.753461,Intraocular pressure exceeded 30 mm Hg in 7.8% assigned to netarsudil vs. 7.4% assigned to placebo (p = 0.84).,"[{'ForeName': 'Marianne O', 'Initials': 'MO', 'LastName': 'Price', 'Affiliation': 'Cornea Research Foundation of America, Indianapolis, IN.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Feng', 'Affiliation': 'Price Vision Group, Indianapolis, IN.'}, {'ForeName': 'Francis W', 'Initials': 'FW', 'LastName': 'Price', 'Affiliation': 'Price Vision Group, Indianapolis, IN. Electronic address: fprice@pricevisiongroup.net.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.09.050']
2410,33045330,Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty is Not Superior to Plain Bupivacaine: A Double Blinded Prospective Randomized Control Trial.,"INTRODUCTION


Interscalene brachial plexus blocks are a common modality utilized to provide adjunctive pain relief with shoulder replacement surgery. In 2018 the Federal Drug Administration approved the use liposomal bupivacaine (LB) for such nerve blocks. We sought to evaluate whether this formulation of bupivacaine would provide superior pain relief for shoulder replacement patients over standard bupivacaine alone. Our hypotheses were that in the LB cohort the average postoperative pain score over the first 72 hours would be significantly lower, time to block cessation would be longer, total opioid consumption would be lower, and the average patient satisfaction score regarding their pain management would be higher.
MATERIALS AND METHODS


A randomized, double-blinded study was designed comparing primary shoulder replacement surgery after an interscalene block with 25 ml of 0.5% plain bupivacaine versus 133 mg of LB with 7.5 ml of 0.5% and 7.5 ml of 0.25% plain bupivacaine. A total of 104 patients were included in the study, with an equal number in each study arm. Patients' visual analogue pain scores were followed for their inpatient stay, first three full outpatient days, and at a three week follow-up. Use of opioid medication was recorded for the same intervals, and converted to morphine milligram equivalents (MME). The time to first opioid rescue was documented, as well as the patients' satisfaction with their pain management at both the 3 day and 3 week intervals.
RESULTS


No clinically relevant advantage to the use of liposomal bupivacaine over plain bupivacaine was found. During the second postoperative day, the mean Visual Analogue Pain Score was 2.4 with liposomal bupivacaine versus 3.3 in the standard cohort. (p=0.0409) The only other statistically significant finding was a higher VAPS with LB during the third full day home compared to standard bupivacaine. (4.0 vs 2.8 respectively, p=0.0197) Both of these differences were less than the minimal clinically important difference of 2 for the VAPS. Analysis of the VAPS for the 1 st  and 3 rd  postoperative days, the 1 st  and 2 nd  full days home, and at 3 weeks revealed no significant difference. Similarly, there was no significant difference in time to first opioid rescue, total MME use, and patient satisfaction with pain management.
CONCLUSION


When used for an interscalene block to provide adjunctive pain relief in shoulder replacement surgery, the addition of liposomal bupivacaine to plain bupivacaine provides no additional clinically important benefit to the patient's pain experience over standard bupivacaine.
LEVEL OF EVIDENCE


Level I; Randomized Controlled Trial; Treatment Study.",2020,"During the second postoperative day, the mean Visual Analogue Pain Score was 2.4 with liposomal bupivacaine versus 3.3 in the standard cohort.","['shoulder replacement patients over standard bupivacaine alone', 'A total of 104 patients were included in the study, with an equal number in each study arm']","['bupivacaine', 'Bupivacaine', 'interscalene block with 25 ml of 0.5% plain bupivacaine', 'Liposomal Bupivacaine Interscalene Nerve Block', 'liposomal bupivacaine', 'liposomal bupivacaine (LB', 'LB with 7.5 ml of 0.5% and 7.5 ml of 0.25% plain bupivacaine', 'primary shoulder replacement surgery', 'plain bupivacaine']","['pain relief', 'mean Visual Analogue Pain Score', 'time to first opioid rescue, total MME use, and patient satisfaction with pain management', 'visual analogue pain scores', 'VAPS with LB', 'total opioid consumption', 'average postoperative pain score', 'time to first opioid rescue']","[{'cui': 'C0186623', 'cui_str': 'Arthroplasty of shoulder with synthetic joint prosthesis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0589495', 'cui_str': 'Interscalene approach'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0186623', 'cui_str': 'Arthroplasty of shoulder with synthetic joint prosthesis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",104.0,0.221793,"During the second postoperative day, the mean Visual Analogue Pain Score was 2.4 with liposomal bupivacaine versus 3.3 in the standard cohort.","[{'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Hattrup', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic Arizona, 5777 East Mayo Blvd, Phoenix, AZ 85054, USA. Electronic address: hattrup.steven@mayo.edu.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Chung', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic Arizona, 5777 East Mayo Blvd, Phoenix, AZ 85054, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Rosenfeld', 'Affiliation': 'Department of Anesthesiology, Mayo Clinic Arizona, 5777 East Mayo Blvd, Phoenix, AZ 85054, USA.'}, {'ForeName': 'Lopa', 'Initials': 'L', 'LastName': 'Misra', 'Affiliation': 'Department of Anesthesiology, Mayo Clinic Arizona, 5777 East Mayo Blvd, Phoenix, AZ 85054, USA.'}, {'ForeName': 'Veerandra', 'Initials': 'V', 'LastName': 'Koyyalamudi', 'Affiliation': 'Department of Anesthesiology, Mayo Clinic Arizona, 5777 East Mayo Blvd, Phoenix, AZ 85054, USA.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Ritz', 'Affiliation': 'Department of Anesthesiology, Mayo Clinic Arizona, 5777 East Mayo Blvd, Phoenix, AZ 85054, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Tokish', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic Arizona, 5777 East Mayo Blvd, Phoenix, AZ 85054, USA.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.09.017']
2411,33045334,Acetaminophen vs. Percocet for Postoperative Pain in Hip Arthroscopy.,"OBJECTIVES


The purpose of the current study was to determine whether post-operative acetaminophen reduced narcotic consumption following hip arthroscopy for femoroacetabular impingement(FAI).
METHODS


This was a single center randomized controlled trial. Opioid-naïve patients undergoing hip arthroscopy for FAI were randomized intotwo groups. The control group received our institution's standard of care for post-operative pain control, 285mg/325mg oxycodone-acetaminophen prescribed as 1-2 tablets every 6 hours as needed for pain; while the treatment group were prescribed 650 mg acetaminophen every 6 hours for pain, with 5mg/325mg oxycodone-acetaminophen prescribed for breakthrough pain. Patients were instructed to be mindful of taking no more than 3gm of acetaminophen in a 24-hour limit. If this limit was reached, oxycodone 5mg would be prescribed.They were contacted daily and asked to report opioid use as well as their level of pain utilizing the VAS pain scale.
RESULTS


Our institution enrolled 86 patients, 80 of whom completed the study (40 control, 40 treatment). There were no statistically significant differences with respect to patient demographics and patient-specific factors between groups (age at time of surgery, gender, ASA, or BMI). Additionally, there was no statistically significant difference with respect to Visual Analogue Scale (VAS) pain between groups preoperatively (P=0.64) or at 1-week follow up (P= 0.39).The treatment group did not utilize a statistically significant different number of narcotics than the control group throughout the first post-operative week (6.325 pillstreatmentvs. 5.688pills control, P= 0.237).
CONCLUSION


The findings of this randomized controlled trial suggest that postoperative acetaminophen may have no effect on reducing the number of narcotic pills consumed by opioid naive patients following hip arthroscopy in the setting of reduced opioid-prescribing on the part of orthopedic surgeons.Furthermore, the results of this study suggest surgeons may reduce postoperative narcotic prescribing without reducing patient satisfaction following hip arthroscopy.",2020,"Additionally, there was no statistically significant difference with respect to Visual Analogue Scale (VAS) pain between groups preoperatively (P=0.64) or at 1-week follow up (P= 0.39).The treatment group did not utilize a statistically significant different number of narcotics than the control group throughout the first post-operative week (6.325 pillstreatmentvs.","['naïve patients undergoing hip arthroscopy for FAI', 'Hip Arthroscopy', 'hip arthroscopy for femoroacetabular impingement(FAI', 'Our institution enrolled 86 patients, 80 of whom completed the study (40 control, 40 treatment']","['acetaminophen', 'postoperative acetaminophen', 'Acetaminophen', 'Opioid', 'oxycodone', 'oxycodone-acetaminophen', ""institution's standard of care for post-operative pain control, 285mg/325mg oxycodone-acetaminophen""]","['Visual Analogue Scale (VAS) pain', 'number of narcotic pills', 'number of narcotics', 'narcotic consumption', 'Postoperative Pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186190', 'cui_str': 'Diagnostic arthroscopy of hip joint'}, {'cui': 'C2936290', 'cui_str': 'Femoral acetabular impingement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0717368', 'cui_str': 'Acetaminophen- and oxycodone-containing product'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",86.0,0.172266,"Additionally, there was no statistically significant difference with respect to Visual Analogue Scale (VAS) pain between groups preoperatively (P=0.64) or at 1-week follow up (P= 0.39).The treatment group did not utilize a statistically significant different number of narcotics than the control group throughout the first post-operative week (6.325 pillstreatmentvs.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Bloom', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kirby', 'Affiliation': ''}, {'ForeName': 'Kamali', 'Initials': 'K', 'LastName': 'Thompson', 'Affiliation': ''}, {'ForeName': 'Samuel L', 'Initials': 'SL', 'LastName': 'Baron', 'Affiliation': ''}, {'ForeName': 'Crist', 'Initials': 'C', 'LastName': 'Chee', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Youm', 'Affiliation': ''}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.09.046']
2412,33045374,A randomized clinical trial of contrast increment protocols for binocular amblyopia treatment.,"BACKGROUND


Most clinical trials of contrast-rebalanced binocular amblyopia treatment used a contrast increment protocol of 10% daily with successful play. Paired with a definition of success requiring only 15-30 min/day of gameplay, this increment protocol could allow children to reach 100% fellow eye contrast in 3-9 hours; however, this may not provide adequate therapeutic time with reduced fellow eye contrast. The purpose of this study was to compare the original protocol against three alternative contrast increment protocols designed to increase the number of treatment hours.
METHODS


In this prospective study, 63 amblyopic children (4-10 years; amblyopic eye visual acuity, 20/40-125) were randomly assigned one of four daily contrast increment protocols for 4 weeks, all starting with 20% fellow eye contrast: 10%, 5%, 0%, or 10% for first 4 weeks then reset to 20% and repeat 10% increment for the final 4 weeks. Children played contrast-rebalanced games for 1 hour/day, 5 days/week. Best-corrected visual acuity, stereoacuity, and suppression were assessed at baseline and every 2 weeks until the 8-week outcome visit.
RESULTS


At baseline, mean amblyopic eye best-corrected visual acuity was 0.47 ± 0.14 logMAR (20/60), improving overall to 0.14 ± 0.08 logMAR (1.4 lines; P < 0.0001) at 8 weeks. All four protocols resulted in similar improvement in visual acuity (0.13-0.16 logMAR; all Ps < 0.0002). Stereoacuity and suppression also improved (all Ps < 0.05).
CONCLUSIONS


None of the new protocols resulted in less improvement than the original 10% contrast increment protocol. Contrast-rebalanced binocular games yielded significant improvements in visual acuity, stereoacuity, and suppression with or without daily contrast increments.",2020,All four protocols resulted in similar improvement in visual acuity (0.13-0.16 logMAR; all Ps < 0.0002).,"['63 amblyopic children (4-10 years; amblyopic eye visual acuity, 20/40-125']",[],"['Stereoacuity and suppression', 'visual acuity', 'visual acuity, stereoacuity, and suppression with or without daily contrast increments', 'mean amblyopic eye best-corrected visual acuity', 'Best-corrected visual acuity, stereoacuity, and suppression']","[{'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0442752', 'cui_str': 'Distance vision 6/12'}, {'cui': 'C4319551', 'cui_str': '125'}]",[],"[{'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]",63.0,0.15286,All four protocols resulted in similar improvement in visual acuity (0.13-0.16 logMAR; all Ps < 0.0002).,"[{'ForeName': 'Reed M', 'Initials': 'RM', 'LastName': 'Jost', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas. Electronic address: reedjost@retinafoundation.org.'}, {'ForeName': 'Krista R', 'Initials': 'KR', 'LastName': 'Kelly', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Hunter', 'Affiliation': 'Heaton Eye Associates, Tyler, Texas.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Stager', 'Affiliation': 'Pediatric Ophthalmology & Adult Strabismus, Plano, Texas.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Luu', 'Affiliation': 'Pediatric Ophthalmology & Adult Strabismus, Plano, Texas.'}, {'ForeName': 'Joel N', 'Initials': 'JN', 'LastName': 'Leffler', 'Affiliation': ""Children's Eye Care of North Texas, Plano, Texas.""}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Dao', 'Affiliation': 'ABC Eyes Pediatric Ophthalmology, Dallas, Texas.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Beauchamp', 'Affiliation': 'ABC Eyes Pediatric Ophthalmology, Dallas, Texas.'}, {'ForeName': 'Eileen E', 'Initials': 'EE', 'LastName': 'Birch', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas; University of Texas Southwestern Medical Center, Dallas, Texas.'}]",Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus,['10.1016/j.jaapos.2020.06.009']
2413,33045376,Single-triangle versus Fox pentagon frontalis suspension for unilateral severe congenital ptosis correction.,"PURPOSE


To compare the functional and cosmetic outcomes of two different frontalis sling techniques for correction of severe unilateral congenital ptosis: single triangle and Fox pentagon techniques using expanded polytetrafluoroethylene (ePTFE) suture.
METHODS


This randomized controlled trial included 60 eyes of 60 patients with severe unilateral simple congenital ptosis and poor levator function (≤4 mm). Participants were randomly assigned for either single triangle or Fox pentagon frontalis suspension using ePTFE suture. Functional outcome measures were margin reflex distance (MRD1), palpebral fissure height (VFH), and lagophthalmos. Cosmetic outcome parameters (lid contour, lid crease, and height symmetry) were graded as 3 (excellent), 2 (good), or 1 (poor), with a minimum of 18 months' follow-up.
RESULTS


At final follow-up, there was a significant improvement in the MRD1 and VFH in both groups, with no statistical difference (P = 0.9). Both groups showed comparative cosmetic results regarding lid height symmetry, crease, and contour. The patients in the single-triangle group showed more rapid recovery of postoperative edema and lagopthalmos with less visible forehead scarring. There were no serious ePTFE sling-related complications.
CONCLUSIONS


In our study cohort, the single-triangle and Fox pentagon frontalis suspension techniques had similar outcomes with respect to MRD1 and VFH and comparable cosmetic results. However, the single-triangle technique avoids two forehead incisions and was associated with less postoperative edema, lagophthalmos, and scarring.",2020,"At final follow-up, there was a significant improvement in the MRD1 and VFH in both groups, with no statistical difference (P = 0.9).","['60 eyes of 60 patients with severe unilateral simple congenital ptosis and poor levator function (≤4 mm', 'severe unilateral congenital ptosis', 'unilateral severe congenital ptosis correction']","['Single-triangle versus Fox pentagon frontalis suspension', 'frontalis sling techniques', 'single triangle or Fox pentagon frontalis suspension using ePTFE suture', 'expanded polytetrafluoroethylene (ePTFE) suture']","['lid height symmetry, crease, and contour', 'margin reflex distance (MRD1), palpebral fissure height (VFH), and lagophthalmos', 'Cosmetic outcome parameters (lid contour, lid crease, and height symmetry', 'rapid recovery of postoperative edema and lagopthalmos with less visible forehead scarring', 'serious ePTFE sling-related complications', 'MRD1 and VFH', 'postoperative edema, lagophthalmos, and scarring']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0266573', 'cui_str': 'Congenital ptosis'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0423105', 'cui_str': 'Degree of levator lift'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C0016632', 'cui_str': 'Fox-Fordyce disease'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0183346', 'cui_str': 'Sling'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0183744', 'cui_str': 'Polytetrafluoroethylene suture'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C1827217', 'cui_str': 'Margin reflex distance'}, {'cui': 'C0423104', 'cui_str': 'Height of palpebral fissure'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1969562', 'cui_str': 'Mental Retardation, Autosomal Dominant 1'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}]",60.0,0.0226658,"At final follow-up, there was a significant improvement in the MRD1 and VFH in both groups, with no statistical difference (P = 0.9).","[{'ForeName': 'Nora Mahmoud', 'Initials': 'NM', 'LastName': 'Mohammed', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Fayoum University, Al Fayoum, Egypt.'}, {'ForeName': 'Mahmoud Ahmed', 'Initials': 'MA', 'LastName': 'Kamal', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Fayoum University, Al Fayoum, Egypt.'}, {'ForeName': 'Mohammed Ahmed', 'Initials': 'MA', 'LastName': 'Abdelhafez', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Fayoum University, Al Fayoum, Egypt.'}, {'ForeName': 'Mostafa Mohammed', 'Initials': 'MM', 'LastName': 'Diab', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Fayoum University, Al Fayoum, Egypt. Electronic address: Mm11@fayoum.edu.eg.'}]",Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus,['10.1016/j.jaapos.2020.06.011']
2414,33052131,Comparing Web-Based Mindfulness With Loving-Kindness and Compassion Training for Promoting Well-Being in Pregnancy: Protocol for a Three-Arm Pilot Randomized Controlled Trial.,"BACKGROUND


Promoting psychological well-being and preventing distress among pregnant women is an important public health goal. In addition to adversely impacting the mother's health and well-being, psychological distress in pregnancy increases the risk of poor pregnancy outcomes, compromises infant socioemotional development and bonding, and heightens maternal and child vulnerability in the postpartum period. Mindfulness and compassion-based interventions show potential for prevention and early intervention for perinatal distress. As there is an established need for accessible, scalable, flexible, and low-cost interventions, there is increased interest in the delivery of these programs on the web. This project aims to pilot a three-arm randomized controlled trial (RCT) to determine the feasibility of a full-scale RCT comparing 2 web-based interventions (mindfulness vs loving-kindness and compassion) with a web-based active control condition (progressive muscle relaxation).
OBJECTIVE


The primary objective of this study is to assess the feasibility of an RCT protocol comparing the 3 conditions delivered on the web as a series of instructional materials and brief daily practices over a course of 8 weeks. The second objective is to explore the experiences of women in the different intervention conditions. The third objective is to estimate SD values for the outcome measures to inform the design of an adequately powered trial to determine the comparative efficacy of the different conditions.
METHODS


Pregnant women (n=75) participating in a longitudinal birth cohort study (the ORIGINS project) will be recruited to this study from 18 weeks of gestational age. We will assess the acceptability and feasibility of recruitment and retention strategies and the participants' engagement and adherence to the interventions. We will also assess the experiences of women in each of the 3 intervention conditions by measuring weekly changes in their well-being and engagement with the program and by conducting a qualitative analysis of postprogram interviews.
RESULTS


This project was funded in September 2019 and received ethics approval on July 8, 2020. Enrollment to the study will commence in September 2020. Feasibility of a full-scale RCT will be assessed using ADePT (a process for decision making after pilot and feasibility trials) criteria.
CONCLUSIONS


If the study is shown to be feasible, results will be used to inform future full-scale RCTs. Evidence for flexible, scalable, and low-cost interventions could inform population health strategies to promote well-being and reduce psychological distress among pregnant women.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry Number 12620000672954p; http://anzctr.org.au/ACTRN12620000672954p.aspx.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/19803.",2020,"Feasibility of a full-scale RCT will be assessed using ADePT (a process for decision making after pilot and feasibility trials) criteria.
","['pregnant women', 'Pregnant women (n=75) participating in a longitudinal birth cohort study (the ORIGINS project) will be recruited to this study from 18 weeks of gestational age', 'Pregnancy']","['full-scale RCT comparing 2 web-based interventions (mindfulness vs loving-kindness and compassion) with a web-based active control condition (progressive muscle relaxation', 'full-scale RCT', 'RCT protocol', 'Web-Based Mindfulness With Loving-Kindness and Compassion Training']","['psychological distress', 'risk of poor pregnancy outcomes, compromises infant socioemotional development and bonding, and heightens maternal and child vulnerability']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]",,0.127455,"Feasibility of a full-scale RCT will be assessed using ADePT (a process for decision making after pilot and feasibility trials) criteria.
","[{'ForeName': 'Amy Louise', 'Initials': 'AL', 'LastName': 'Finlay-Jones', 'Affiliation': 'Telethon Kids Institute, Nedlands, Australia.'}, {'ForeName': 'Jacqueline Ann', 'Initials': 'JA', 'LastName': 'Davis', 'Affiliation': 'Telethon Kids Institute, Nedlands, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': ""O'Donovan"", 'Affiliation': 'Murdoch University, Murdoch, Australia.'}, {'ForeName': 'Keerthi', 'Initials': 'K', 'LastName': 'Kottampally', 'Affiliation': 'Telethon Kids Institute, Nedlands, Australia.'}, {'ForeName': 'Rebecca Anne', 'Initials': 'RA', 'LastName': 'Ashley', 'Affiliation': 'Murdoch University, Murdoch, Australia.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'Silva', 'Affiliation': 'Telethon Kids Institute, Nedlands, Australia.'}, {'ForeName': 'Jeneva Lee', 'Initials': 'JL', 'LastName': 'Ohan', 'Affiliation': 'University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Prescott', 'Affiliation': 'Telethon Kids Institute, Nedlands, Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Downs', 'Affiliation': 'Telethon Kids Institute, Nedlands, Australia.'}]",JMIR research protocols,['10.2196/19803']
2415,33052251,The Impact of App-Delivered Mindfulness Meditation on Functional Connectivity and Self-Reported Mindfulness Among Health Profession Trainees.,"Objectives


Previous research indicates that mindfulness meditation reduces anxiety and depression and enhances well-being. We examined the impact of app-delivered mindfulness meditation on resting state functional MRI (fMRI) connectivity among physician assistant (PA) students and surgery residents.
Methods


PA students and residents were randomized to receive a popular meditation app or to wait-list control group. Before and after the 8-week meditation period, we acquired fMRI scans of participants' resting state, and participants completed a self-report measure of mindfulness. We used a 2 × 2, within- and between-group factorial design and leveraged a whole-brain connectome approach to examine changes in within- and between-network connectivity across the entire brain, and to examine whether changes in connectivity were associated with app use or to changes in self-reported mindfulness.
Results


Meditation practitioners exhibited significantly stronger connectivity between the frontoparietal network and the left and right nucleus accumbens and between the default mode (DMN) and salience networks, among other regions. Mindfulness practice time was correlated with increased connectivity between the lateral parietal cortex and the supramarginal gyrus, which were also positively correlated with increased scores on the ""Describing"" subscale of the Five Facet Mindfulness Questionnaire between baseline and post-meditation. These findings are consistent with previous research indicating that mindfulness-based interventions alter functional connectivity within the DMN and between the DMN and other networks both during meditation and at rest, as well as increased connectivity in systems important for emotion and reward.
Conclusions


Recent commentaries call for healthcare provider and trainee wellness programs that are sustainable and preventive in nature rather than reactive; these data indicate that even brief sessions of app-delivered mindfulness practice are associated with functional connectivity changes in a dose-dependent manner.",2020,"Mindfulness practice time was correlated with increased connectivity between the lateral parietal cortex and the supramarginal gyrus, which were also positively correlated with increased scores on the ""Describing"" subscale of the Five Facet Mindfulness Questionnaire between baseline and post-meditation.","['physician assistant (PA) students and surgery residents', 'Health Profession Trainees', 'Methods\n\n\nPA students and residents']","['App-Delivered Mindfulness Meditation', 'popular meditation app or to wait-list control group', 'app-delivered mindfulness meditation', 'mindfulness meditation']","['Describing"" subscale of the Five Facet Mindfulness Questionnaire', 'Functional Connectivity and Self-Reported Mindfulness', 'resting state functional MRI (fMRI) connectivity', 'anxiety and depression and enhances well-being', 'Mindfulness practice time']","[{'cui': 'C0031833', 'cui_str': 'Physician assistant'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0018722', 'cui_str': 'Health Professions'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",5.0,0.0163758,"Mindfulness practice time was correlated with increased connectivity between the lateral parietal cortex and the supramarginal gyrus, which were also positively correlated with increased scores on the ""Describing"" subscale of the Five Facet Mindfulness Questionnaire between baseline and post-meditation.","[{'ForeName': 'Jeremy L', 'Initials': 'JL', 'LastName': 'Smith', 'Affiliation': 'Department of Radiology and Imaging Sciences, Emory University, Atlanta, GA USA.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Allen', 'Affiliation': 'Department of Radiology and Imaging Sciences, Emory University, Atlanta, GA USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Haack', 'Affiliation': 'Department of Surgery, Emory University, Atlanta, GA USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Wehrmeyer', 'Affiliation': 'Department of Family and Preventive Medicine, Emory University, 1841 Clifton Road NE, Suite 507, Atlanta, GA 30329 USA.'}, {'ForeName': 'Kayley', 'Initials': 'K', 'LastName': 'Alden', 'Affiliation': 'Department of Family and Preventive Medicine, Emory University, 1841 Clifton Road NE, Suite 507, Atlanta, GA 30329 USA.'}, {'ForeName': 'Maha B', 'Initials': 'MB', 'LastName': 'Lund', 'Affiliation': 'Department of Family and Preventive Medicine, Physician Assistant Program, Emory University, Atlanta, GA USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Mascaro', 'Affiliation': 'Department of Family and Preventive Medicine, Emory University, 1841 Clifton Road NE, Suite 507, Atlanta, GA 30329 USA.'}]",Mindfulness,['10.1007/s12671-020-01502-7']
2416,33052270,Cardio-Protective Effects of Multiport Antegrade Cold Blood Cardioplegia Versus Antegrade Cold Blood Cardioplegia in Patients With Left Ventricular Systolic Dysfunction Undergoing Conventional Coronary Artery Bypass Grafting.,"Introduction The aim of this study was to compare the in-hospital outcomes of multiport antegrade cold blood cardioplegia through vein grafts versus conventional antegrade cold blood cardioplegia in patients with left ventricle systolic dysfunction who underwent coronary artery bypass grafting (CABG). Methods This prospective, randomized clinical study was comprised of patients undergoing on-pump CABG at the Ch. Pervaiz Elahi Institute of Cardiology in Multan, Pakistan from November 18, 2018 to December 17, 2019. Patients with multivessel coronary artery disease and left ventricular systolic dysfunction (ejection fraction < 50%) were included. In Group A (N = 73), multiport antegrade cold blood vein graft cardioplegia was given after every distal anastomosis completed for myocardial preservation. In Group B (N = 73), conventional antegrade cold blood cardioplegia was given for myocardial preservation. Results Spontaneous rhythm (without defibrillation applied) after cross-clamp removal was higher in Group A than in Group B (93.3% vs. 85.2%, p < 0.05). Duration of support, ventilation time, and hospital stay were also significantly lower in Group A than in Group B with p = 0.00001, p = 0.03, and p = 0.002, respectively. Intra-aortic balloon pump insertion (4.1% vs. 23.0%, p = 0.02) and operative mortality (0.5% vs. 4.0%, p = 0.35) were also lower in Group A than in Group B. Postoperative left ventricular ejection fraction (LVEF) increased more in Group A than in Group B, and the postoperative LVEF mean value was 44.68% in Group A versus 41.26% in Group B (p = 0.02). Conclusion Multiport vein graft blood cardioplegia provides superior myocardial protection in patients with left ventricular systolic dysfunction who underwent CABG. It is also easy to administer, so this technique can be adopted as a routine method for myocardial protection in patients with left ventricular dysfunction planned for on-pump CABG.",2020,"Intra-aortic balloon pump insertion (4.1% vs. 23.0%, p = 0.02) and operative mortality (0.5% vs. 4.0%, p = 0.35) were also lower in Group A than in Group B. Postoperative left ventricular ejection fraction (LVEF) increased more in Group A than in Group B, and the postoperative LVEF mean value was 44.68% in Group A versus 41.26% in Group B (p = 0.02).","['Patients with multivessel coronary artery disease and left ventricular systolic dysfunction (ejection fraction < 50%) were included', 'Patients', 'patients with left ventricle systolic dysfunction who underwent coronary artery bypass grafting (CABG', 'Pervaiz Elahi Institute of Cardiology in Multan, Pakistan\xa0from November 18, 2018\xa0to December 17, 2019', 'patients undergoing on-pump CABG at the Ch', 'patients with left ventricular dysfunction planned for on-pump CABG', 'patients with left ventricular systolic dysfunction who underwent CABG']","['Multiport vein graft blood cardioplegia', 'Multiport Antegrade Cold Blood Cardioplegia Versus Antegrade Cold Blood Cardioplegia', 'multiport antegrade cold blood vein graft cardioplegia', 'Conventional Coronary Artery Bypass Grafting', 'conventional antegrade cold blood cardioplegia', 'multiport antegrade cold blood cardioplegia through vein grafts versus conventional antegrade cold blood cardioplegia']","['Duration of support, ventilation time, and hospital stay', 'Postoperative left ventricular ejection fraction (LVEF', 'operative mortality', 'postoperative LVEF mean value']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1277187', 'cui_str': 'Left ventricular systolic dysfunction'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0225897', 'cui_str': 'Left cardiac ventricular structure'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0242973', 'cui_str': 'Ventricular dysfunction'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}]","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.030641,"Intra-aortic balloon pump insertion (4.1% vs. 23.0%, p = 0.02) and operative mortality (0.5% vs. 4.0%, p = 0.35) were also lower in Group A than in Group B. Postoperative left ventricular ejection fraction (LVEF) increased more in Group A than in Group B, and the postoperative LVEF mean value was 44.68% in Group A versus 41.26% in Group B (p = 0.02).","[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Ali', 'Affiliation': 'Cardiac Surgery, Chaudhry Pervaiz Elahi Institute of Cardiology, Multan, PAK.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Moeen', 'Affiliation': 'Cardiac Surgery, Chaudhry Pervaiz Elahi Institute of Cardiology, Multan, PAK.'}, {'ForeName': 'Iftikhar', 'Initials': 'I', 'LastName': 'Paras', 'Affiliation': 'Cardiac Surgery, Chaudhry Pervaiz Elahi Institute of Cardiology, Multan, PAK.'}, {'ForeName': 'Waqas', 'Initials': 'W', 'LastName': 'Hamid', 'Affiliation': 'Cardiac Surgery, Sheikh Zayed Medical College/Hospital, Rahim Yar Khan, PAK.'}, {'ForeName': 'Saadat', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Echocardiography, Tabba Heart Institute, Karachi, PAK.'}, {'ForeName': 'Muhammad Hamid', 'Initials': 'MH', 'LastName': 'Chaudhary', 'Affiliation': 'Cardiac Surgery, Chaudhry Pervaiz Elahi Institute of Cardiology, Multan, PAK.'}]",Cureus,['10.7759/cureus.10308']
2417,33052285,Creation and Evaluation of a Cesarean Section Simulator Training Program for Novice Obstetric Surgeons.,"BACKGROUND


We evaluated a novel simulation-based cesarean section training program to teach critical techniques for cesarean section and hemorrhage management.  Methods: This was a prospective educational intervention. After Institutional Review Board approval, we recruited Obstetrics and Gynecology, Family Medicine, and General Surgery residents at three hospitals. All participants received didactic education. Participants were then randomized into two arms with one group to receive task-trainer based training and the other no training. Afterwards, all residents had their performance of a complete cesarean section and management of a post-partum hemorrhage evaluated on a high-fidelity simulator. Evaluators were blinded to randomization.
EXPERIENCE


Thirty-three participants were recruited between July 2017 and January 2019. There were 19 trainees in the control group and 14 in the intervention group. The intervention group scored significantly higher on performance of the cesarean delivery (p-value 0.007), hemorrhage management (p-value 0.0002), and overall skill (p-value 0.008). There were no differences in the other categories.
CONCLUSION


Participants trained with a combination of didactic education and task-trainers versus didactic education alone performed significantly better on all procedural aspects of a cesarean section and hemorrhage management on a high-fidelity simulator, demonstrating that simulation-based training allows trainees to gain procedural experience while decreasing patient risk.",2020,"The intervention group scored significantly higher on performance of the cesarean delivery (p-value 0.007), hemorrhage management (p-value 0.0002), and overall skill (p-value 0.008).","['Thirty-three participants were recruited between July 2017 and January 2019', 'recruited Obstetrics and Gynecology, Family Medicine, and General Surgery residents at three hospitals', 'Novice Obstetric Surgeons']","['didactic education', 'Cesarean Section Simulator Training Program', 'didactic education\xa0and task-trainers versus didactic education alone', 'task-trainer based training and the other no training']","['overall skill', 'complete cesarean section and management of a post-partum hemorrhage', 'performance of the cesarean delivery', 'hemorrhage management']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",33.0,0.0850487,"The intervention group scored significantly higher on performance of the cesarean delivery (p-value 0.007), hemorrhage management (p-value 0.0002), and overall skill (p-value 0.008).","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Foglia', 'Affiliation': 'Maternal Fetal Medicine, Womack Army Medical Center, Fort Bragg, USA.'}, {'ForeName': 'Allison A', 'Initials': 'AA', 'LastName': 'Eubanks', 'Affiliation': 'Obstetrics and Gynecology, Walter Reed National Military Medical Center, Bethesda, USA.'}, {'ForeName': 'Logan C', 'Initials': 'LC', 'LastName': 'Peterson', 'Affiliation': 'Obstetrics and Gynecology, Walter Reed National Military Medical Center, Bethesda, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Hickey', 'Affiliation': 'Maternal Fetal Medicine, Walter Reed National Military Medical Center, Bethesda, USA.'}, {'ForeName': 'Crystal B', 'Initials': 'CB', 'LastName': 'Hammons', 'Affiliation': 'Obstetrics and Gynecology, Madigan Army Medical Center, Tacoma, USA.'}, {'ForeName': 'Lindsey B', 'Initials': 'LB', 'LastName': 'Borgia', 'Affiliation': 'Obstetrics and Gynecology, Fort Belvoir Community Hospital, Fort Belvoir, USA.'}, {'ForeName': 'Morgan R', 'Initials': 'MR', 'LastName': 'Light', 'Affiliation': 'Obstetrics and Gynecology, Walter Reed National Military Medical Center, Bethesda, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Jackson', 'Affiliation': 'Obstetrics and Gynecology, Walter Reed National Military Medical Center, Bethesda, USA.'}, {'ForeName': 'Shad', 'Initials': 'S', 'LastName': 'Deering', 'Affiliation': 'Obstetrics and Gynecology, Christus Health, San Antonio, USA.'}]",Cureus,['10.7759/cureus.10324']
2418,33001537,Trichloroacetic acid 35% as a therapeutic line for localized patchy alopecia areata in comparison with intralesional steroids: Clinical and trichoscopic evaluation.,"BACKGROUND


Intralesional corticosteroids (ILCs) is the first-line therapy for patients older than 10 years having patchy alopecia areata, however some patients do not respond effectively.
AIMS


To evaluate the efficacy of a chemical peel trichloro acetic acid (TCA 35%) in comparison to ILCs.
PATIENTS/METHODS


Twenty-two patients with two patches of alopecia areata were included. Two treatment modalities with ILCs and topical TCA 35% were performed in two randomly selected patches. Three sessions were done, 3 weeks apart and were followed-up for three months. Evaluation was done using Mac Donald Hull and Norris grading system and by counting trichoscopic parameters in each patch.
RESULTS


Both ILCs and TCA 35% treated patches showed measurable improvement with no statistically significant difference between the results of the two modalities (p>0.05) at different times of the study. Yellow dots, black dots, exclamation marks and dystrophic hair were all reduced by 100%, 82.0%, 100% and 88.3% in ILCs treated patches and by 70.4%, 69.1%, 100% and 75.0% in TCA treated patches, respectively.
CONCLUSION


Topical TCA 35% is an effective and safe treatment for the treatment of AA without serious side effects, despite the slower response when compared to ILCs.",2020,Both ILCs and TCA 35% treated patches showed measurable improvement with no statistically significant difference between the results of the two modalities (p>0.05) at different times of the study.,"['patients older than 10 years having patchy alopecia areata', 'Twenty-two patients with two patches of alopecia areata were included']","['chemical peel trichloro acetic acid (TCA 35', 'Topical TCA', 'Intralesional corticosteroids (ILCs', 'Trichloroacetic acid', 'ILCs and topical TCA']","['Yellow dots, black dots, exclamation marks and dystrophic hair']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1862862', 'cui_str': 'Patchy alopecia'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0441218', 'cui_str': 'Two patches'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0007979', 'cui_str': 'Chemexfoliation of skin'}, {'cui': 'C0040900', 'cui_str': 'Trichloroacetic acid'}, {'cui': 'C0041405', 'cui_str': 'Turks and Caicos Islands'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0333484', 'cui_str': 'Fatty streaks'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0544849', 'cui_str': 'Hair dystrophy'}]",2.0,0.0358756,Both ILCs and TCA 35% treated patches showed measurable improvement with no statistically significant difference between the results of the two modalities (p>0.05) at different times of the study.,"[{'ForeName': 'Doaa A', 'Initials': 'DA', 'LastName': 'Mahgoub', 'Affiliation': 'Dermatology Department Kasr Al Ainy Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Tamarah I', 'Initials': 'TI', 'LastName': 'Dhannoon', 'Affiliation': 'Dermatology Department Kasr Al Ainy Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Marwa S', 'Initials': 'MS', 'LastName': 'El-Mesidy', 'Affiliation': 'Dermatology Department Kasr Al Ainy Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13749']
2419,33035593,Functional and cognitive responses to caffeine intake in middle-aged women are dose depending.,"Middle-aged women display many physiological and cognitive alterations resulting from aging and physical inactivity as well as other changes that occur as a function of menopause. Caffeine consumption is highest in this age with women having a particular greater sensitivity to caffeine than men. Its effects on functional and cognitive functions are controversial and seem to depend on the dose intake. This study aimed to assess the effect of low (100mg) and high (400mg) doses of caffeine consumption on cognitive (simple reaction time) and functional (upper and low body muscle endurance, aerobic endurance and functional mobility) performances. These performances were evaluated in 19 healthy middle-aged women by the 30-Second Chair Stand test for lower body muscle endurance, the 30sec Arm Curl Test for upper body muscle endurance, the 2-Minute Step test for aerobic endurance, The Timed Up and Go test for functional mobility and the simple reaction time test for reaction time, 60min after a treatment capsule intake (100mg caffeine/400mg caffeine/placebo). Low caffeine consumption significantly improved (p<.005) cognitive performance, while high caffeine consumption did not. However, the functional performance significantly improved (p<.05) after high caffeine consumption but not after low caffeine consumption. Except, the functional mobility performance significantly improved (p<.05) after both low and high caffeine consumption with better improvement (p<.05) after the high dose. In conclusion, low caffeine consumption improved cognitive performance and high caffeine consumption improved functional performance but the functional mobility improved after both low and high caffeine consumption in middleaged women.",2020,"However, the functional performance significantly improved (p<.05) after high caffeine consumption but not after low caffeine consumption.","['middleaged women', '19 healthy middle-aged women by the', 'middle-aged women', 'Middle-aged women']","['caffeine consumption', '30-Second Chair Stand test for lower body muscle endurance, the 30sec Arm Curl Test for upper body muscle endurance, the 2-Minute Step test for aerobic endurance, The Timed Up and Go test for functional mobility and the simple reaction time test for reaction time, 60min after a treatment capsule intake (100mg caffeine/400mg caffeine/placebo']","['Low caffeine consumption significantly improved (p<.005) cognitive performance', 'cognitive performance', 'Functional and cognitive responses', 'cognitive (simple reaction time) and functional (upper and low body muscle endurance, aerobic endurance and functional mobility) performances', 'functional mobility performance', 'Caffeine consumption', 'functional performance', 'functional mobility']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}]","[{'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",19.0,0.026942,"However, the functional performance significantly improved (p<.05) after high caffeine consumption but not after low caffeine consumption.","[{'ForeName': 'Fatma Ben', 'Initials': 'FB', 'LastName': 'Waer', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia. Electronic address: fatmaelwaer123@gmail.com.'}, {'ForeName': 'Rabeb', 'Initials': 'R', 'LastName': 'Laatar', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}, {'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'Jouira', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Srihi', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}, {'ForeName': 'Haithem', 'Initials': 'H', 'LastName': 'Rebai', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Sahli', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112956']
2420,33048561,The effects of brief behavioral activation (BA) on children with physical disabilities: A randomized controlled trial.,"The majority of children with physical disabilities experience significant restrictions in their daily lives. Notably, they are at a risk for lower levels of activity and involvement in critical life domains. To address this issue, this study investigated whether behavioral activation (BA), in tandem with the installment of power-assisted devices (PAD), would have beneficial effects on activity levels, overall involvement in life domains, mobility, and depressive symptoms among children with physical disabilities. From among 123 children with physical disabilities aged 6-13 who used a nonpowered wheelchair device, 40 who met the inclusion and exclusion criteria were randomized into either the PAD-only group or the BA + PAD group. The participants were assessed at 3 time periods (pretreatment, 4 weeks, and 8 weeks), using standardized self-report measures and digital odometers. Both groups showed an increase in the distance traveled. Although BA + PAD had no additional benefits over PAD-only in improving the distance traveled and depressive symptoms, the BA + PAD group showed significantly higher levels of activity and overall involvement in life domains than the PAD-only group did. The findings provide preliminary support for the provision of BA for children with physical disabilities. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Although BA + PAD had no additional benefits over PAD-only in improving the distance traveled and depressive symptoms, the BA + PAD group showed significantly higher levels of activity and overall involvement in life domains than the PAD-only group did.","['123 children with physical disabilities aged 6-13 who used a nonpowered wheelchair device, 40 who met the inclusion and exclusion criteria', 'children with physical disabilities']","['power-assisted devices (PAD', 'PAD-only group or the BA + PAD group', 'behavioral activation (BA']","['levels of activity and overall involvement in life domains', 'distance traveled and depressive symptoms', 'activity levels, overall involvement in life domains, mobility, and depressive symptoms', 'distance traveled']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184423', 'cui_str': 'Manual wheelchair'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",123.0,0.0913853,"Although BA + PAD had no additional benefits over PAD-only in improving the distance traveled and depressive symptoms, the BA + PAD group showed significantly higher levels of activity and overall involvement in life domains than the PAD-only group did.","[{'ForeName': 'Jong-Woo', 'Initials': 'JW', 'LastName': 'Suh', 'Affiliation': 'Department of Psychology, Korea University.'}, {'ForeName': 'Eun-Byeol', 'Initials': 'EB', 'LastName': 'Lee', 'Affiliation': 'Department of Psychology, Korea University.'}, {'ForeName': 'Yeoul', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Psychology, Korea University.'}, {'ForeName': 'Min-Goo', 'Initials': 'MG', 'LastName': 'Lee', 'Affiliation': 'Department of Physiology, College of Medicine, Korea University.'}, {'ForeName': 'Kee-Hong', 'Initials': 'KH', 'LastName': 'Choi', 'Affiliation': 'Department of Psychology, Korea University.'}]",The American journal of orthopsychiatry,['10.1037/ort0000517']
2421,33048569,Treatment of friendship problems in children with attention-deficit/hyperactivity disorder: Initial results from a randomized clinical trial.,"OBJECTIVE


This study evaluated a novel intervention for friendship problems in children with attention-deficit/hyperactivity disorder (ADHD). Parental Friendship Coaching (PFC) teaches parents to coach their children in targeted friendship behaviors that are lacking in children with ADHD and that help children develop good quality friendships.
METHOD


Participants were 172 families of children with ADHD and social impairment (ages 6-11; 29.7% female) at two Canadian sites, randomized to PFC or to an active comparison intervention (Coping with ADHD through Relationships and Education; CARE) to control for common therapy factors. Questionnaire and observational measures assessing primary outcomes of children's friendship quality and secondary outcomes of children's friendship behaviors were collected at baseline, posttreatment, and 8-month follow-up.
RESULTS


Across both treatment conditions, children showed improvements in positive friendship quality and in friendship behaviors. Relative to CARE, PFC was associated with somewhat more positive and less negative friendship behaviors at posttreatment and follow-up, but no difference between conditions was found in friendship quality. However, moderation analyses suggested that PFC may contribute to better friendship quality among families who had previous psychosocial treatment, as well as children with comorbid externalizing disorders.
CONCLUSIONS


Although PFC showed some efficacy for affecting children's friendship behaviors, these changes may not translate into friendship quality. Nevertheless, PFC may improve friendship quality for at-risk subgroups of children with ADHD. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Relative to CARE, PFC was associated with somewhat more positive and less negative friendship behaviors at posttreatment and follow-up, but no difference between conditions was found in friendship quality.","['children with attention-deficit/hyperactivity disorder', 'Participants were 172 families of children with ADHD and social impairment (ages 6-11; 29.7% female) at two Canadian sites', 'children with comorbid externalizing disorders', 'children with attention-deficit/hyperactivity disorder (ADHD']","['friendship problems', 'active comparison intervention (Coping with ADHD through Relationships and Education; CARE', 'novel intervention', 'Parental Friendship Coaching (PFC', 'PFC']","['friendship quality', ""children's friendship quality and secondary outcomes of children's friendship behaviors"", 'negative friendship behaviors', 'positive friendship quality and in friendship behaviors']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0476259,"Relative to CARE, PFC was associated with somewhat more positive and less negative friendship behaviors at posttreatment and follow-up, but no difference between conditions was found in friendship quality.","[{'ForeName': 'Amori Yee', 'Initials': 'AY', 'LastName': 'Mikami', 'Affiliation': 'Department of Psychology, University of British Columbia.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Normand', 'Affiliation': 'Département de Psychoéducation et de Psychologie, Université du Québec en Outaouais.'}, {'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Hudec', 'Affiliation': 'Department of Psychology, University of British Columbia.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Guiet', 'Affiliation': 'Département de Psychoéducation et de Psychologie, Université du Québec en Outaouais.'}, {'ForeName': 'Jennifer Jiwon', 'Initials': 'JJ', 'LastName': 'Na', 'Affiliation': 'Department of Psychology, University of British Columbia.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Smit', 'Affiliation': 'Department of Psychology, University of British Columbia.'}, {'ForeName': 'Adri', 'Initials': 'A', 'LastName': 'Khalis', 'Affiliation': 'Department of Psychology, University of British Columbia.'}, {'ForeName': 'Marie-France', 'Initials': 'MF', 'LastName': 'Maisonneuve', 'Affiliation': ""Clinique d'apprentissage spécialisée.""}]",Journal of consulting and clinical psychology,['10.1037/ccp0000607']
2422,33048570,Effectiveness of online OurRelationship and ePREP programs for low-income military couples.,"OBJECTIVE


Military couples need and desire relationship interventions. Online interventions improve access; however, their effectiveness within the military population is untested. Using a subsample from a larger randomized controlled trial of OurRelationship and ePREP online relationship programs for low-income couples, this study examined baseline characteristics of military compared with civilian couples enrolled (Aim 1), treatment effects within military couples (Aim 2), and treatment differences between military and matched civilian participants (Aim 3).
METHOD


Military couples (n = 90 couples) in which 1 or both partners were active duty (11%) or veterans (89%) were selected from the larger randomized controlled trial along with a matched civilian sample selected using propensity scores.
RESULTS


No differences were found between military and civilian couples regarding baseline individual or relationship functioning. Program completion was lower among military couples (57%) compared with civilians (71%), whereas program satisfaction was equally positive. Among military couples, relationship satisfaction, conflict, emotional support, and breakup potential were significantly improved after treatment (between-groups d = 0.31-0.46) and maintained at follow-up; intimate partner violence and individual functioning domains did not improve. When comparing military and civilian samples, there was a pattern of stronger treatment impacts on individual functioning for civilians, although only the impact on insomnia evidenced a significant difference.
CONCLUSIONS


These online relationship interventions improved relationship functioning for military couples. More research is needed to test these interventions among clinically impaired military populations and to explore potential for improving program completion and effects on relationship violence and individual wellbeing. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Program completion was lower among military couples (57%) compared with civilians (71%), whereas program satisfaction was equally positive.","['military couples', 'low-income couples', 'low-income military couples', 'Military couples (n = 90 couples) in which 1 or both partners were active duty (11%) or veterans (89']","['online OurRelationship and ePREP programs', 'OurRelationship and ePREP online relationship programs', 'online relationship interventions']","['relationship satisfaction, conflict, emotional support, and breakup potential', 'program satisfaction']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",90.0,0.0795957,"Program completion was lower among military couples (57%) compared with civilians (71%), whereas program satisfaction was equally positive.","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Georgia Salivar', 'Affiliation': 'Department of Clinical and School Psychology, College of Psychology, Nova Southeastern University.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Knopp', 'Affiliation': 'Veteran Affairs San Diego Healthcare System.'}, {'ForeName': 'McKenzie K', 'Initials': 'MK', 'LastName': 'Roddy', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Services, Baylor College of Medicine.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Morland', 'Affiliation': 'Veteran Affairs San Diego Healthcare System.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Doss', 'Affiliation': 'Department of Psychology, University of Miami.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000606']
2423,33048572,Lower self-efficacy and greater depressive symptoms predict greater failure to recover from a single lapse cigarette.,"OBJECTIVE


Smoking reexposure after a quit attempt (i.e., lapse) increases relapse risk, but lapse recovery is possible. Using a 6-day analogue model of smoking cessation and lapse, this study tested the effect of a single lapse cigarette on the risk of subsequent smoking. Abstinence self-efficacy (ASE) and depressive symptoms (using the Center for Epidemiological Studies Depression Scale, CES-D) were also examined as hypothesized moderators of lapse recovery.
METHOD


After receiving cessation counseling and achieving 2 days of incentivized abstinence, 54 daily smokers (mean age: 41 years, 61% African American, 63% male) were randomly assigned to smoke 1 cigarette or to a no-lapse control condition. Participants were then offered monetary incentives to abstain for 3 more days and smoking was monitored.
RESULTS


Compared to the control condition, participants who experienced a lapse had a 2.5 times greater risk of smoking in the first 24 hours Furthermore, a lapse resulted in much greater risk of subsequent smoking compared to the control condition among individuals with lower postquit ASE scores (p = .044) and greater CES-D scores (p = .040).
CONCLUSIONS


These findings provide preliminary evidence that a single lapse cigarette after quitting plays a causal role in subsequent smoking and suggest that individuals with lower postquit ASE and greater depressive symptoms are less likely to recover from a lapse. Future research should investigate factors associated with lapse recovery and failure so that effective lapse-responsive strategies can be developed. Laboratory models provide an efficient and controlled method to examine such processes. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Compared to the control condition, participants who experienced a lapse had a 2.5 times greater risk of smoking in the first 24 hours","['54 daily smokers (mean age: 41 years, 61% African American, 63% male']",['smoke 1 cigarette or to a no-lapse control condition'],"['risk of subsequent smoking', 'Abstinence self-efficacy (ASE) and depressive symptoms', 'CES-D scores', 'depressive symptoms', 'risk of smoking']","[{'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0141529,"Compared to the control condition, participants who experienced a lapse had a 2.5 times greater risk of smoking in the first 24 hours","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Muench', 'Affiliation': 'Department of Psychology, American University.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Malloy', 'Affiliation': 'Department of Math and Statistics, American University.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Juliano', 'Affiliation': 'Department of Psychology, American University.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000605']
2424,33048581,Safety and feasibility of the PEPPER adaptive bolus advisor and safety system; a randomized control study.,"<b>Background:</b> The Patient Empowerment through Predictive Personalised Decision Support (PEPPER) system provides personalised bolus advice for people with Type 1 diabetes. The system incorporates an adaptive insulin recommender system (based on case-based reasoning, an artificial intelligence methodology), coupled with a safety system which includes predictive glucose alerts and alarms, predictive low-glucose suspend, personalised carbohydrate recommendations and dynamic bolus insulin constraint. We evaluated the safety and feasibility of the PEPPER system compared to a standard bolus calculator. <b>Methods:</b> This was an open-labelled multicentre randomized controlled cross-over study. Following 4-week run-in, participants were randomized to PEPPER/Control or Control/PEPPER in a 1:1 ratio for 12-weeks. Participants then crossed over after a wash-out period. The primary end-point was percentage time in range (TIR, 3.9mmol/L-10.0mmol/L (70-180mg/dL)). Secondary outcomes included glycaemic variability, quality of life, and outcomes on the safety system and insulin recommender. <b>Results:</b> 54 participants on multiple daily injections (MDI) or insulin pump completed the run-in period, making up the intention-to-treat analysis. Median (interquartile range) age was 41.5 (32.3-49.8) years, diabetes duration 21.0 (11.5-26.0) years and HbA1c 61.0 (58.0-66.1) mmol/mol. No significant difference was observed for percentage TIR between the PEPPER and Control groups (62.5 (52.1-67.8) % vs 58.4 (49.6-64.3) % respectively, p=0.27). For quality of life, participants reported higher perceived hypoglycaemia with the PEPPER system despite no objective difference in time spent in hypoglycaemia. <b><b>Conclusions:</b></b> The PEPPER system was safe but did not change glycaemic outcomes, compared to control. There is wide scope for integrating PEPPER into routine diabetes management for pump and MDI users. Further studies are required to confirm overall effectiveness.",2020,The Patient Empowerment through Predictive Personalised Decision Support (PEPPER) system provides personalised bolus advice for people with Type 1 diabetes.,"['Median (interquartile range) age was 41.5 (32.3-49.8) years, diabetes duration 21.0 (11.5-26.0) years and HbA1c 61.0 (58.0-66.1) mmol/mol', 'people with Type 1 diabetes']","['PEPPER/Control or Control/PEPPER', 'Predictive Personalised Decision Support (PEPPER) system', 'PEPPER adaptive bolus advisor and safety system', 'PEPPER system', 'PEPPER']","['time spent in hypoglycaemia', 'percentage time in range (TIR, 3.9mmol/L-10.0mmol/L', 'glycaemic variability, quality of life, and outcomes on the safety system and insulin recommender', 'percentage TIR']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3853035', 'cui_str': 'Patient Empowerment'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0574173', 'cui_str': 'Tigrinya language'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",,0.10598,The Patient Empowerment through Predictive Personalised Decision Support (PEPPER) system provides personalised bolus advice for people with Type 1 diabetes.,"[{'ForeName': 'Parizad', 'Initials': 'P', 'LastName': 'Avari', 'Affiliation': 'Imperial College London, 4615, Department of Metabolism, Digestion and Reproduction, London, United Kingdom of Great Britain and Northern Ireland; p.avari@imperial.ac.uk.'}, {'ForeName': 'Yenny', 'Initials': 'Y', 'LastName': 'Leal', 'Affiliation': 'IDIBGI, 486227, Diabetes, Endocrinology and Nutrition Unit, Girona, Catalunya, Spain; yleal@idibgi.org.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Herrero', 'Affiliation': 'Imperial College London, 4615, Department of Electrical and Electronic Engineering, London, United Kingdom of Great Britain and Northern Ireland; p.herrero-vinias@imperial.ac.uk.'}, {'ForeName': 'Marzena', 'Initials': 'M', 'LastName': 'Wos', 'Affiliation': 'IDIBGI, 486227, Diabetes, Endocrinology and Nutrition Unit, Girona, Catalunya, Spain; marzannawos@gmail.com.'}, {'ForeName': 'Narvada', 'Initials': 'N', 'LastName': 'Jugnee', 'Affiliation': 'Imperial College London, 4615, Department of Metabolism, Digestion and Reproduction, London, United Kingdom of Great Britain and Northern Ireland; n.jugnee@imperial.ac.uk.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Arnoriaga-Rodríguez', 'Affiliation': 'IDIBGI, 486227, Diabetes, Endocrinology and Nutrition Unit, Girona, Catalunya, Spain; marnoriaga@idibgi.org.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Imperial College London, 4615, Department of Metabolism, Digestion and Reproduction, London, United Kingdom of Great Britain and Northern Ireland; m.thomas@imperial.ac.uk.'}, {'ForeName': 'Chengyuan', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Imperial College London, 4615, Department of Electrical and Electronic Engineering, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Quim', 'Initials': 'Q', 'LastName': 'Massana', 'Affiliation': ""University of Girona, 16738, eXiT research group, Institut d'Informàtica i Aplicacions, Girona, Catalunya, Spain; quim.massana@hotmail.com.""}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Lopez', 'Affiliation': ""University of Girona, 16738, eXiT research group, Institut d'Informàtica i Aplicacions, Girona, Catalunya, Spain; beatriz.lopez@udg.edu.""}, {'ForeName': 'Lucian', 'Initials': 'L', 'LastName': 'Nita', 'Affiliation': 'RomSoft SRL, Department of Research & Development, Iasi, Romania; luc@rms.ro.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Martin', 'Affiliation': 'Oxford Brookes University, 6395, School of Engineering, Computing, and Mathematics, Oxford, Oxfordshire, United Kingdom of Great Britain and Northern Ireland; cemartin@brookes.ac.uk.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Fernandez-Real', 'Affiliation': 'IDIBGI, 486227, Diabetes, Endocrinology and Nutrition Unit, Girona, Catalunya, Spain.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Oliver', 'Affiliation': 'Imperial College London, 4615, Faculty of Medicine, London, United Kingdom of Great Britain and Northern Ireland; nick.oliver@imperial.ac.uk.'}, {'ForeName': 'Merce', 'Initials': 'M', 'LastName': 'Fernandez', 'Affiliation': 'IDIBGI, 486227, Diabetes, Endocrinology and Nutrition Unit, Girona, Catalunya, Spain; mercefernandez.girona.ics@gencat.cat.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Reddy', 'Affiliation': 'Imperial College London, 4615, Department of Metabolism, Digestion and Reproduction, London, United Kingdom of Great Britain and Northern Ireland; m.reddy@imperial.ac.uk.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0301']
2425,33048589,Day-to-day Relationships between Physical Activity and Sleep Characteristics among People with Heart Failure and Insomnia.,"OBJECTIVE


Examine the bidirectional relationships between within-person day-to-day fluctuations in physical activity (PA) and sleep characteristics among people with heart failure (HF) and insomnia.
PARTICIPANTS


Ninety-seven community-dwelling adults [median age 61.9 (interquartile range 55.3,70.9) years, female 41%] with stable HF and insomnia (insomnia severity index >7).
METHODS


This sub-study longitudinally analyzed 15 consecutive days and nights of wrist actigraphy recordings, that were collected for baseline data prior to participation in a randomized controlled trial of cognitive behavioral therapy for insomnia. We used two-level mixed models of within- (daily) and between-participants variation to predict daytime PA counts/minutes from sleep variables (total sleep time, sleep efficiency) and predict sleep variables from PA.
RESULTS


PA counts/minutes were low compared to prior cohorts that did not have HF (209 (166,259)) and negatively associated with NYHA class (standardized coefficient β s  = -0.14,  p  < .01), age (β s  = -0.13,  p  = .01), comorbidities (β s  = -0.19,  p  < .01), and body mass index (β s  = -0.12,  p  = .04). After adjustment for all significant covariates, the within-participant association of total sleep time with next-day PA was estimated to be positive among participants with NYHA class II-IV HF (β s  = 0.09,  p  = .01), while the within-participant association of PA with same-night total sleep time was estimated to be positive among participants aged ≥60 years (β s  = 0.10,  p  = .03).
CONCLUSIONS


Depending upon age and HF class, daytime PA was associated with longer same-night sleep and/or longer sleep was associated with greater next-day PA. Among those with more advanced HF, realistic sleep improvements were associated with clinically meaningful PA gains the next day.",2020,"Depending upon age and HF class, daytime PA was associated with longer same-night sleep and/or longer sleep was associated with greater next-day PA.","['People with Heart Failure and Insomnia', 'Ninety-seven community-dwelling adults [median age 61.9 (interquartile range 55.3,70.9) years, female 41%] with stable HF and insomnia (insomnia severity index >7', 'people with heart failure (HF) and insomnia', 'participants aged ≥60\xa0years ']",['cognitive behavioral therapy'],"['daytime PA counts/minutes from sleep variables (total sleep time, sleep efficiency', 'body mass index', 'NYHA class', 'total sleep time']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0456387', 'cui_str': 'Class'}]",,0.027765,"Depending upon age and HF class, daytime PA was associated with longer same-night sleep and/or longer sleep was associated with greater next-day PA.","[{'ForeName': 'Garrett', 'Initials': 'G', 'LastName': 'Ash', 'Affiliation': 'Yale University School of Nursing , Orange, Connecticut, USA.'}, {'ForeName': 'Sangchoon', 'Initials': 'S', 'LastName': 'Jeon', 'Affiliation': 'Yale University School of Nursing , Orange, Connecticut, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Conley', 'Affiliation': 'Yale University School of Nursing , Orange, Connecticut, USA.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Knies', 'Affiliation': 'Yale University School of Nursing , Orange, Connecticut, USA.'}, {'ForeName': 'Henry K', 'Initials': 'HK', 'LastName': 'Yaggi', 'Affiliation': 'Veterans Affairs Connecticut Healthcare System , West Haven, Connecticut, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jacoby', 'Affiliation': 'Department of Internal Medicine (Cardiovascular Medicine), Yale School of Medicine , New Haven, Connecticut, USA.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Hollenbeak', 'Affiliation': 'Department of Health Policy and Administration, The Pennsylvania State University , University Park, Pennsylvania, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Linsky', 'Affiliation': 'Yale University School of Nursing , Orange, Connecticut, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': ""O'Connell"", 'Affiliation': 'Yale University School of Nursing , Orange, Connecticut, USA.'}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Redeker', 'Affiliation': 'Yale University School of Nursing , Orange, Connecticut, USA.'}]",Behavioral sleep medicine,['10.1080/15402002.2020.1824918']
2426,33045287,"Mirabegron versus Placebo Add-on Therapy in Men with Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: a Safety Analysis from the Randomized, Phase 4 PLUS Study.","OBJECTIVES


To analyze the safety of mirabegron add-on therapy in men with overactive bladder symptoms concurrently receiving tamsulosin for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
METHODS


The Phase 4 PLUS study comprised a 4-week run-in period (tamsulosin [0.4 mg]) and a 12-week randomized treatment period (add-on treatment: mirabegron [25 mg] or placebo). Doses were increased to mirabegron 50 mg or matched placebo after 4 weeks. Safety assessments: treatment-emergent adverse events (TEAEs), vital signs, 12-lead electrocardiograms (ECGs), and changes in post-void residual (PVR) volume and maximum urinary flow (Q max ).
RESULTS


The safety analysis set included 352 tamsulosin plus mirabegron (TAM+MIRA) and 354 tamsulosin plus placebo (TAM+PL) patients. The frequency of overall TEAEs was higher with TAM+PL, although a higher incidence of drug-related TEAEs was observed with TAM+MIRA. Most TEAEs were mild or moderate in severity. Drug-related serious TEAEs were reported for three patients (two TAM+MIRA patients: acute myocardial infarction with cerebral infarction and angina pectoris, one TAM+PL patient: lacunar stroke). Hypertension, headache, and nasopharyngitis were the most common TEAEs. Special interest TEAEs were infrequently reported. The most common was urinary retention and two TAM+MIRA patients required catheterization (neither led to discontinuation). No major changes in blood pressure or pulse rate were noted and similar ECG parameters were observed for both groups. Changes in mean PVR volume and Q max  were not clinically meaningful.
CONCLUSION


No unexpected safety concerns were noted in men receiving tamsulosin for LUTS associated with BPH who subsequently received mirabegron add-on therapy.",2020,"The frequency of overall TEAEs was higher with TAM+PL, although a higher incidence of drug-related TEAEs was observed with TAM+MIRA.","['Men with Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia', 'patients', 'three patients (two TAM+MIRA patients: acute myocardial infarction with cerebral infarction and angina pectoris, one TAM+PL patient: lacunar stroke', 'men with overactive bladder symptoms concurrently receiving tamsulosin for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH']","['tamsulosin plus mirabegron (TAM+MIRA) and 354 tamsulosin plus placebo (TAM+PL', '4-week run-in period (tamsulosin [0.4 mg]) and a 12-week randomized treatment period (add-on treatment: mirabegron [25 mg] or placebo', 'tamsulosin', 'Mirabegron versus Placebo', 'mirabegron 50 mg or matched placebo']","['frequency of overall TEAEs', 'Safety assessments: treatment-emergent adverse events (TEAEs), vital signs, 12-lead electrocardiograms (ECGs), and changes in post-void residual (PVR) volume and maximum urinary flow (Q max ', 'ECG parameters', 'Hypertension, headache, and nasopharyngitis', 'blood pressure or pulse rate', 'mean PVR volume and Q max']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3178801', 'cui_str': 'Lacunar stroke'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C3474335', 'cui_str': 'mirabegron 50 MG'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}]",,0.105879,"The frequency of overall TEAEs was higher with TAM+PL, although a higher incidence of drug-related TEAEs was observed with TAM+MIRA.","[{'ForeName': 'Sender', 'Initials': 'S', 'LastName': 'Herschorn', 'Affiliation': 'Department of Surgery/Urology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL; Department of Urology, Infanta Leonor Hospital, Madrid, Spain; Department of Urology, Royal Berkshire Hospital, Reading, UK; Astellas Pharma Global Development Inc., Northbrook, IL; Astellas Pharma Europe Ltd., Chertsey, UK; Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY. Electronic address: Sender.Herschorn@sunnybrook.ca.'}, {'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'McVary', 'Affiliation': 'Department of Surgery/Urology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL; Department of Urology, Infanta Leonor Hospital, Madrid, Spain; Department of Urology, Royal Berkshire Hospital, Reading, UK; Astellas Pharma Global Development Inc., Northbrook, IL; Astellas Pharma Europe Ltd., Chertsey, UK; Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY.'}, {'ForeName': 'Javier Cambronero', 'Initials': 'JC', 'LastName': 'Santos', 'Affiliation': 'Department of Surgery/Urology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL; Department of Urology, Infanta Leonor Hospital, Madrid, Spain; Department of Urology, Royal Berkshire Hospital, Reading, UK; Astellas Pharma Global Development Inc., Northbrook, IL; Astellas Pharma Europe Ltd., Chertsey, UK; Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Foley', 'Affiliation': 'Department of Surgery/Urology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL; Department of Urology, Infanta Leonor Hospital, Madrid, Spain; Department of Urology, Royal Berkshire Hospital, Reading, UK; Astellas Pharma Global Development Inc., Northbrook, IL; Astellas Pharma Europe Ltd., Chertsey, UK; Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY.'}, {'ForeName': 'Rita M', 'Initials': 'RM', 'LastName': 'Kristy', 'Affiliation': 'Department of Surgery/Urology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL; Department of Urology, Infanta Leonor Hospital, Madrid, Spain; Department of Urology, Royal Berkshire Hospital, Reading, UK; Astellas Pharma Global Development Inc., Northbrook, IL; Astellas Pharma Europe Ltd., Chertsey, UK; Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY.'}, {'ForeName': 'Nurul', 'Initials': 'N', 'LastName': 'Choudhury', 'Affiliation': 'Department of Surgery/Urology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL; Department of Urology, Infanta Leonor Hospital, Madrid, Spain; Department of Urology, Royal Berkshire Hospital, Reading, UK; Astellas Pharma Global Development Inc., Northbrook, IL; Astellas Pharma Europe Ltd., Chertsey, UK; Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hairston', 'Affiliation': 'Department of Surgery/Urology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL; Department of Urology, Infanta Leonor Hospital, Madrid, Spain; Department of Urology, Royal Berkshire Hospital, Reading, UK; Astellas Pharma Global Development Inc., Northbrook, IL; Astellas Pharma Europe Ltd., Chertsey, UK; Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': 'Department of Surgery/Urology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL; Department of Urology, Infanta Leonor Hospital, Madrid, Spain; Department of Urology, Royal Berkshire Hospital, Reading, UK; Astellas Pharma Global Development Inc., Northbrook, IL; Astellas Pharma Europe Ltd., Chertsey, UK; Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY.'}]",Urology,['10.1016/j.urology.2020.09.040']
2427,33045290,Catheter Removal on the Same Day of Holmium Laser Enucleation of the Prostate: Outcomes of a Pilot Study.,"OBJECTIVES


To determine if same day catheter removal is feasible in select population after holmium laser enucleation of the prostate (HoLEP).
METHODS


We performed an analysis of patients undergoing HoLEP at our institution who underwent same-day catheter removal after HoLEP. All HoLEPs were performed with Moses Optimized for BPH. Patients were dismissed from postoperative recovery unit (POCU) to the clinic for catheter removal and voiding trial.
RESULTS


To date, 30 patients have undergone same day catheter removal. Median age is 68.6 years (IQR 61.8-73.3) and preoperative prostate volume 81 ml (IQR 53-114.8). Median enucleation time was 39.5 min (IQR 30.5-53), morcellation time was 5 min (IQR 4-12 min) and enucleated specimen weight was 52.5 g (IQR 33-81).  27 (90%) patients successfully voided on the same day without requiring catheter replacement. All patients were catheter free by POD1. For patients who successfully passed their voiding trial, the median time from the end of the procedure to hospital discharge was 2.6 hours (IQR (2.1-2.9) and from the end of the HoLEP to catheter removal was 4.9 hours (IQR 3.5-6.0).
CONCLUSIONS


We present for the first time that same day catheter removal is a feasible option in a select population of patients undergoing HoLEP. With more study, this has the potential for transforming the management of BPH, especially larger glands.",2020,"Median enucleation time was 39.5 min (IQR 30.5-53), morcellation time was 5 min (IQR 4-12 min) and enucleated specimen weight was 52.5 g (IQR 33-81).  ","['patients undergoing HoLEP at our institution who underwent same-day catheter removal after HoLEP', 'patients undergoing HoLEP', '30 patients have undergone same day catheter removal', 'select population after holmium laser enucleation of the prostate (HoLEP']",['Holmium Laser Enucleation'],"['hospital discharge', 'morcellation time', 'enucleated specimen weight', 'HoLEP to catheter removal', 'Median enucleation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}]","[{'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C4042900', 'cui_str': 'Morcellation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0546925,"Median enucleation time was 39.5 min (IQR 30.5-53), morcellation time was 5 min (IQR 4-12 min) and enucleated specimen weight was 52.5 g (IQR 33-81).  ","[{'ForeName': 'Deepak K', 'Initials': 'DK', 'LastName': 'Agarwal', 'Affiliation': 'Department of Urology, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Marcelino E', 'Initials': 'ME', 'LastName': 'Rivera', 'Affiliation': 'Department of Urology, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Charles U', 'Initials': 'CU', 'LastName': 'Nottingham', 'Affiliation': 'Department of Urology, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Large', 'Affiliation': 'Department of Urology, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Krambeck', 'Affiliation': 'Department of Urology, Indiana University School of Medicine, Indianapolis, IN. Electronic address: akrambeck@iuhealth.org.'}]",Urology,['10.1016/j.urology.2020.09.038']
2428,33045402,The vitamin D for COVID-19 (VIVID) trial: A pragmatic cluster-randomized design.,"OBJECTIVES


To determine the effect of vitamin D supplementation on disease progression and post-exposure prophylaxis for COVID-19 infection. We hypothesize that high-dose vitamin D3 supplementation will reduce risk of hospitalization/death among those with recently diagnosed COVID-19 infection and will reduce risk of COVID-19 infection among their close household contacts.
METHODS


We report the rationale and design of a planned pragmatic, cluster randomized, double-blinded trial (N = 2700 in total nationwide), with 1500 newly diagnosed individuals with COVID-19 infection, together with up to one close household contact each (~1200 contacts), randomized to either vitamin D3 (loading dose, then 3200 IU/day) or placebo in a 1:1 ratio and a household cluster design. The study duration is 4 weeks. The primary outcome for newly diagnosed individuals is the occurrence of hospitalization and/or mortality. Key secondary outcomes include symptom severity scores among cases and changes in the infection (seroconversion) status for their close household contacts. Changes in vitamin D 25(OH)D levels will be assessed and their relation to study outcomes will be explored.
CONCLUSIONS


The proposed pragmatic trial will allow parallel testing of vitamin D3 supplementation for early treatment and post-exposure prophylaxis of COVID-19. The household cluster design provides a cost-efficient approach to testing an intervention for reducing rates of hospitalization and/or mortality in newly diagnosed cases and preventing infection among their close household contacts.",2020,The household cluster design provides a cost-efficient approach to testing an intervention for reducing rates of hospitalization and/or mortality in newly diagnosed cases and preventing infection among their close household contacts.,"['COVID-19 infection', 'N\u202f=\u202f2700 in total nationwide), with 1500 newly diagnosed individuals with COVID-19 infection, together with up to one close household contact each (~1200 contacts']","['vitamin D supplementation', 'vitamin D3 supplementation', 'placebo', 'vitamin D3']","['occurrence of hospitalization and/or mortality', 'risk of hospitalization/death', 'vitamin D 25(OH)D levels', 'symptom severity scores among cases and changes in the infection (seroconversion) status for their close household contacts']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C4517675', 'cui_str': '2700'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0517627', 'cui_str': 'Infection status'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",,0.515984,The household cluster design provides a cost-efficient approach to testing an intervention for reducing rates of hospitalization and/or mortality in newly diagnosed cases and preventing infection among their close household contacts.,"[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, USA; Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, MA, USA. Electronic address: rwang@hsph.harvard.edu.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'DeGruttola', 'Affiliation': 'Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Quanhong', 'Initials': 'Q', 'LastName': 'Lei', 'Affiliation': 'Takeda Pharmaceutical Company, MA, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Mayer', 'Affiliation': 'Fenway Health, and Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Redline', 'Affiliation': ""Division of Sleep Medicine and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Hazra', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Walter C', 'Initials': 'WC', 'LastName': 'Willett', 'Affiliation': ""Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Davaasambuu', 'Initials': 'D', 'LastName': 'Ganmaa', 'Affiliation': ""Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106176']
2429,33045417,"Allogeneic Mesenchymal Precursor Cells Treatment for Chronic Low Back Pain Associated with Degenerative Disc Disease: A Prospective Randomized, Placebo-Controlled 36-Month Study of Safety and Efficacy.","BACKGROUND CONTEXT PURPOSE


Evaluate the safety and efficacy of a single injection of STRO-3+ adult allogeneic mesenchymal precursor cells (MPCs) combined with hyaluronic acid (HA) in subjects with chronic low back pain (CLBP) associated with degenerative disc disease (DDD) through 36 months follow-up.
STUDY DESIGN/SETTING


A multicenter, randomized, controlled study conducted at 13 clinical sites (12 in the United States and one in Australia).
SUBJECT SAMPLE


A total of 100 subjects with chronic low back pain associated with moderate DDD (modified Pfirrmann score of 3-6) at one level from L1 to S1 for at least 6 months and failing three months of conservative treatment, including physical therapy were randomized in a 3:3:2:2 ratio to receive 6 million MPCs with HA, 18 million MPCs with HA, HA vehicle control, or saline control (placebo) treatment.
OUTCOME MEASURES


Subjects were clinically and radiographically evaluated at 1, 3, 6, 12, 24, and 36 months post-injection. Subject reported outcomes including adverse events, LBP on a Visual Analog Scale (VAS), Oswestry Disability Index (ODI), SF-36 and Work Productivity and Activity Index (WPAI) were collected.
METHODS


Clinical and radiographic measures were collected at each visit. All randomized subjects were included in the safety assessments and analyzed based on the treatment received. Safety assessments included assessments of AEs, physical and radiographic examinations and laboratory testing. Efficacy assessments evaluated changes in VAS, ODI and modified Pfirrmann (MP) scores between all active and control groups respectively. Assessments included least squares mean (Mean), LS mean change from baseline (Mean Change) and responder analyses in order to assess the clinical significance of observed changes from baseline. The population for efficacy assessments was adjusted for the confounding effects of post-treatment interventions (PTIs). This study was conducted under an FDA Investigational New Drug (IND) application sponsored and funded by [identifying information removed for blinding purposes].
RESULTS


There were significant differences between the control and MPC groups for improvement in VAS and ODI. The PTI corrected VAS and ODI Means and Mean Change analyses; the proportion of subjects with VAS ≥30% and ≥50% improvement from baseline; absolute VAS score ≤ 20; and ODI reduction ≥10 and ≥15 points from baseline showed MPC therapy superior to controls at various timepoints through 36 months. Additionally, the proportion of subjects achieving the minimally important change (MIC) and clinically significant change (CSC) composite endpoints for the MPC groups was also superior compared with controls at various time points from baseline to 36 months. There were no significant differences in change in MP score from baseline across the groups. There were also no statistically significant differences in change in modified MP score at the level above or below the level treated between study arms. Both the procedure and treatment were well tolerated and there were no clinical symptoms of immune reaction to allogeneic MPCs. There was a low rate of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and the rates of these events in the MPC groups were not significantly different from the control groups. One TEAE of severe back pain was possibly related to study agent and one TEAE of implantation site infection was considered to be related to the study procedure.
CONCLUSIONS


Results provide evidence that intra-discal injection of MPCs could be a safe, effective, durable and minimally invasive therapy for subjects who have CLBP associated with moderate DDD.",2020,"There was a low rate of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and the rates of these events in the MPC groups were not significantly different from the control groups.","['Degenerative Disc Disease', '100 subjects with chronic low back pain associated with moderate DDD (modified Pfirrmann score of 3-6) at one level from L1 to S1 for at least 6 months and failing three months of conservative treatment, including physical therapy', 'subjects with chronic low back pain (CLBP) associated with degenerative disc disease (DDD) through 36 months follow-up', 'subjects who have CLBP associated with moderate DDD', 'Chronic Low Back Pain', '13 clinical sites (12 in the United States and one in Australia']","['Allogeneic Mesenchymal Precursor Cells Treatment', '6 million MPCs with HA, 18 million MPCs with HA, HA vehicle control, or saline control (placebo) treatment', 'Placebo', 'STRO-3+ adult allogeneic mesenchymal precursor cells (MPCs) combined with hyaluronic acid (HA']","['adverse events, LBP on a Visual Analog Scale (VAS), Oswestry Disability Index (ODI), SF-36 and Work Productivity and Activity Index (WPAI', 'VAS, ODI and modified Pfirrmann (MP) scores', 'PTI corrected VAS and ODI Means', 'Safety and Efficacy', 'severe back pain', 'MP score', 'least squares mean (Mean), LS mean change', 'low rate of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and the rates of these events', 'modified MP score', 'proportion of subjects achieving the minimally important change (MIC) and clinically significant change (CSC) composite endpoints', 'VAS and ODI', 'assessments of AEs, physical and radiographic examinations and laboratory testing']","[{'cui': 'C0158266', 'cui_str': 'Degeneration of intervertebral disc'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3179739', 'cui_str': 'lanthanum citrate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0391072', 'cui_str': 'platinum (bis(acetato))(ethylenediamine) diiodide'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}]",100.0,0.0543839,"There was a low rate of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and the rates of these events in the MPC groups were not significantly different from the control groups.","[{'ForeName': 'Kasra', 'Initials': 'K', 'LastName': 'Amirdelfan', 'Affiliation': 'IPM Medical Group, Inc., 450 Wiget Lane, Walnut Creek, CA 94598, United States. Electronic address: kasdaq@gmail.com.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Bae', 'Affiliation': 'The Spine Institute, 2811 Wilshire Blvd, Suite 850, Santa Monica, CA 90403, United States. Electronic address: baemd@me.com.'}, {'ForeName': 'Tory', 'Initials': 'T', 'LastName': 'McJunkin', 'Affiliation': 'Arizona Pain Specialists, 9787 N. 91st St, Suite 101, Scottsdale, AZ 85258, United States. Electronic address: torymcj@gmail.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'DePalma', 'Affiliation': 'Virginia Spine Research Institute, Inc., 9020 Stony Point Parkway, Suite 140, Richmond, VA 23235, United States. Electronic address: michaeldepalma8@gmail.com.'}, {'ForeName': 'Kee', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'UC Davis Spine Center, 3301 C Street, Suite 1500, Sacramento, CA 95816, United States. Electronic address: kdkim@ucdavis.edu.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Beckworth', 'Affiliation': 'Department of Orthopaedics, Emory University School of Medicine, 59 Executive Park South, Suite 3000, Atlanta, GA 30329, United States. Electronic address: WBECKWO@emory.edu.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Ghiselli', 'Affiliation': 'Denver Spine, 7800 E. Orchard Rd, Suite 100, Greenwood Village, CO 80111, United States. Electronic address: gg@denverspinesurgeons.com.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Bainbridge', 'Affiliation': 'Denver Spine, 7800 E. Orchard Rd, Suite 100, Greenwood Village, CO 80111, United States. Electronic address: jsb@denverbackpainspecialists.com.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Dryer', 'Affiliation': 'Central Texas Spine Institute, 6818 Austin Center Blvd, Suite 200, Austin, TX 78731, United States. Electronic address: randydryer@gmail.com.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Deer', 'Affiliation': 'The Center for Pain Relief, Inc., 400 Court Street, Suite 100, Charleston, WV 25301, United States. Electronic address: doctdeer@aol.com.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Brown', 'Affiliation': 'Mesoblast Inc., 12912 Hill Country Blvd., Building F, Suite 230, Bee Cave, TX 78738, United States. Electronic address: roger.brown@mesoblast.com.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.10.004']
2430,33045448,Evaluation of the effect of trans-vaginal ovarian needle punctures on women with polycystic ovary syndrome.,"OBJECTIVE


Evaluation of the effectiveness of ultrasound-guided trans-vaginal ovarian needle punctures on improving the management of women with polycystic ovary syndrome resistant to clomiphene citrate.
METHODS


This was a randomized clinical trial conducted in a tertiary Hospital, from June 2016 to December 2018. We recruited twenty- seven women with resistant PCOS with either primary or secondary infertility. They were randomly assigned into two groups. Group one included patients who had a trial of induction using aromatase inhibitors (Letrozol 2.5 mg twice daily from day 2 of the cycle and for 5 days) and FSH administered with 75 IU daily from cycle day 3 and maintained for up to the 14th day of the cycle. Group two included patients who had transvaginal ovarian puncture prior to induction with AIs and gonadotropins. Folliculometery was done starting from day 9 of the cycle. When the follicle reaches a size of 18-25 mm, HCG was given to enhance ovulation.
RESULTS


There was a significant improvement in the hormonal profile (serum LH, FSH, and testosterone with a p- value of 0.0001, 0.007, and 0.0001 respectively) in the study group after one month of treatment. The overall number of ovulatory cycles was significantly higher in the study group than the control group [84 % (62/74), 62.8 % (49/78), p- value 0.006 respectively]. The cumulative pregnancy rates were significantly higher in the study group [33.3 % (9/27)]. No complications related to the procedure were reported.
CONCLUSION


transvaginal ovarian needle puncture is a safe and effective procedure.",2020,"There was a significant improvement in the hormonal profile (serum LH, FSH, and testosterone with a p- value of 0.0001, 0.007, and 0.0001 respectively) in the study group after one month of treatment.","['women with polycystic ovary syndrome', 'a tertiary Hospital, from June 2016 to December 2018', 'women with polycystic ovary syndrome resistant to clomiphene citrate', 'Group one included patients who had a trial of induction using', 'seven women with resistant PCOS with either primary or secondary infertility']","['HCG', 'trans-vaginal ovarian needle punctures', 'transvaginal ovarian puncture prior to induction with AIs and gonadotropins', 'ultrasound-guided trans-vaginal ovarian needle punctures', 'transvaginal ovarian needle puncture', 'aromatase inhibitors (Letrozol 2.5\u2009mg twice daily from day 2 of the cycle and for 5 days) and FSH']","['overall number of ovulatory cycles', 'hormonal profile (serum LH, FSH, and testosterone with a p- value', 'cumulative pregnancy rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0269230', 'cui_str': 'Secondary female infertility'}]","[{'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",27.0,0.103873,"There was a significant improvement in the hormonal profile (serum LH, FSH, and testosterone with a p- value of 0.0001, 0.007, and 0.0001 respectively) in the study group after one month of treatment.","[{'ForeName': 'Khaled A', 'Initials': 'KA', 'LastName': 'Atwa', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, Egypt. Electronic address: kh_atwa@hotmail.com.'}, {'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Farrag', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, Egypt. Electronic address: mouselhy@hotmail.com.'}, {'ForeName': 'Moamen M', 'Initials': 'MM', 'LastName': 'El-Sayed', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, Egypt. Electronic address: mo2mengomaa@yahoo.com.'}, {'ForeName': 'Omima T', 'Initials': 'OT', 'LastName': 'Taha', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, Egypt. Electronic address: omimatharwat@yahoo.com.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elprince', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, Egypt. Electronic address: prince.ma939@yahoo.com.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101937']
2431,33045501,Changes in fetoplacental Doppler indices following intrapartum maternal sildenafil citrate treatment.,"OBJECTIVE


Uterine contractions during labour can result in a 60 % decline in fetoplacental perfusion, predisposing the fetus to hypoxic brain injury. Sildenafil citrate (SC) has shown promise in increasing uteroplacental perfusion as well as reducing the risk of operative birth for intrapartum fetal compromise (IFC). The aim of this study was to investigate the effect of intrapartum SC administration on fetoplacental blood flow indices.
METHODS


This was a subgroup analysis from an earlier Phase II double blind randomized controlled trial; assessing the effect of intrapartum SC administration (50 mg orally 8 -hly in labour) compared to placebo for the reduction of operative birth for IFC. An ultrasound scan measuring fetoplacental Doppler indices was performed prior to and 1-4 h after the administration of the first treatment dose.
RESULTS


Of the 300 women randomized to the main study, pre-treatment ultrasound scans were performed in 261 participants who received the study medication; paired pre- and post-treatment scans were performed in 70 (26.8 %). SC resulted in an increase in the middle cerebral artery pulsatility index (PI) z-score [+0.08 (1.35) vs.-0.12 (1.15)], a decline in the umbilical artery-PI z-score [-0.07 (0.96) vs. + 0.04 (1.25)] and an increase in the cerebroplacental ratio [MCA-PI/UA-PI] (CPR) z-score [+0.10 (1.13) vs.-0.26 (1.14)] although these failed to reach statistical significance. Amongst those with a pre-treatment CPR above the 5th centile, SC significantly reduced the risk of operative birth for IFC compared to placebo [logrank p = 0.02; hazards ratio 0.48, 95 % CI 0.29-0.77, p = 0.003].
CONCLUSION


Although the differences in Doppler indices pre- and post- SC treatment were non-significant, there was a clear trend towards a reduction in the UA PI, a corresponding increase in the MCA PI and a rise in post treatment CPR values suggesting potential improvement in fetoplacental Dopplers with intrapartum SC treatment. However this study was limited by the small sample size. The results of this hypothesis generating study suggest that it may be possible to stratify women that would most benefit from this intervention based upon their pre-labour CPR.",2020,"Amongst those with a pre-treatment CPR above the 5th centile, SC significantly reduced the risk of operative birth for IFC compared to placebo [logrank p = 0.02; hazards ratio 0.48, 95 % CI 0.29-0.77, p = 0.003].
",['300 women randomized to the main study'],"['intrapartum SC administration (50\u2009mg orally 8\u2009-hly in labour', 'placebo', 'SC', 'Sildenafil citrate (SC', 'intrapartum SC']","['fetoplacental blood flow indices', 'cerebroplacental ratio', 'risk of operative birth for IFC', 'middle cerebral artery pulsatility index (PI) z-score', 'fetoplacental Doppler indices', 'umbilical artery-PI z-score']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0041632', 'cui_str': 'Structure of umbilical artery'}]",300.0,0.176329,"Amongst those with a pre-treatment CPR above the 5th centile, SC significantly reduced the risk of operative birth for IFC compared to placebo [logrank p = 0.02; hazards ratio 0.48, 95 % CI 0.29-0.77, p = 0.003].
","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Mater Research Institute, University of Queensland, Level 3 Aubigny Place, Raymond Terrace, South Brisbane, Queensland, 4101, Australia; Faculty of Medicine, University of Queensland, Whitty Building, Annerley Road, South Brisbane, Queensland, 4101, Australia.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Dunn', 'Affiliation': 'Mater Research Institute, University of Queensland, Level 3 Aubigny Place, Raymond Terrace, South Brisbane, Queensland, 4101, Australia.'}, {'ForeName': 'Sailesh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Mater Research Institute, University of Queensland, Level 3 Aubigny Place, Raymond Terrace, South Brisbane, Queensland, 4101, Australia; Faculty of Medicine, University of Queensland, Whitty Building, Annerley Road, South Brisbane, Queensland, 4101, Australia. Electronic address: sailesh.kumar@mater.uq.edu.au.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.09.042']
2432,33045783,[Application of three-dimensional digital simulated design and implementation in esthetic rehabilitation].,"Objective:  To explore and evaluate a three-dimensional (3D) digital simulated design and implementation technique in esthetic rehabilitation.  Methods:  Thirty patients with esthetic deficiency, who came to the Department of Prosthodontics, Peking University School and Hospital of Stomatology from December 2017 to July 2019, were recruited and randomly assigned into 2 groups. Four males and 11 females which were (36.0±10.5) years old in the experimental group, 6 males and 9 females which were (32.0±6.7) years old in the control group, were enrolled. In the experimental group, 3D digital simulated design was used to predict the post-treatment effect; and the final restorations were designed duplicating from the pre-treatment digital design confirmed by the patient and milled. In the control group, the final restorations were manufactured by the dental technician according to the design of two-dimensional (2D) digital smile design. The simulation degree of digital design and the similarity between preoperative design and postoperative rehabilitation were scored by the patients with visual analogue scales (VAS) in both groups; and the satisfaction rate to the restorations was evaluated by the patients. The quality of the restorations was accessed by a prosthodontist who did not know the grouping of patients according to the modified criteria of United States Public Health Service (USPHS).  Results:  Three-dimensional digital simulated design and implementation technique was successfully established. The VAS score on the simulation degree of digital design in the experimental group (8.5±0.5) was higher than that in the control group (7.2±0.7) ( P <0.01); the VAS score on the similarity between preoperative design and postoperative rehabilitation in the experimental group (9.6±0.3) was higher than that in the control group (7.0±0.9) ( P <0.01). The satisfaction rate of the patients to the restorations was significantly higher in the experimental group than in the control group ( P <0.05). There was no significant difference of the quality of the restorations between the two groups on the anatomic form, the marginal adaption and the surface quality ( P >0.05).  Conclusions:  Three-dimensional digital simulated design and implementation technique can help achieving 3D digital simulated design before treatment and duplication to the final restorations, and can improve the patients' satisfaction in esthetic rehabilitation.",2020,"There was no significant difference of the quality of the restorations between the two groups on the anatomic form, the marginal adaption and the surface quality ( P >0.05).  ","['esthetic rehabilitation', 'Four males and 11 females which were (36.0±10.5) years old in the experimental group, 6 males and 9 females which were (32.0±6.7) years old in the control group, were enrolled', 'Thirty patients with esthetic deficiency, who came to the Department of Prosthodontics, Peking University School and Hospital of Stomatology from December 2017 to July 2019']",[],"['marginal adaption and the surface quality', 'quality of the restorations', 'visual analogue scales (VAS', 'satisfaction rate', 'VAS score', 'postoperative rehabilitation']","[{'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0033590', 'cui_str': 'Prosthodontics'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029167', 'cui_str': 'Medicine, Oral'}]",[],"[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]",30.0,0.0180982,"There was no significant difference of the quality of the restorations between the two groups on the anatomic form, the marginal adaption and the surface quality ( P >0.05).  ","[{'ForeName': 'H Q', 'Initials': 'HQ', 'LastName': 'Ye', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Liu', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'G B', 'Initials': 'GB', 'LastName': 'Wang', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Wang', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Liu', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': 'Center of Dental Laboratory, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'Y C', 'Initials': 'YC', 'LastName': 'Sun', 'Affiliation': 'Center of Digital Dentistry, Faculty of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Research Center of Engineering and Technology for Digital Dentistry of Ministry of Health & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Zhou', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}]",Zhonghua kou qiang yi xue za zhi = Zhonghua kouqiang yixue zazhi = Chinese journal of stomatology,['10.3760/cma.j.cn112144-20200712-00412']
2433,33045870,Comparison of two different shapes of stylets for intubation with the McGrath MAC® video laryngoscope: a randomized controlled trial.,"OBJECTIVE


This study was performed to compare two different shapes of stylets, 60° and J-shaped stylets, for intubation using the McGrath MAC® video laryngoscope (MVL).
METHODS


Two hundred twenty-two patients undergoing surgery under general anesthesia were randomly allocated to Group J (n = 111) or Group 60° (n = 111) and intubated using the MVL with the stylet bent into the allocated shape. The time to intubation (TTI) and other intubating profiles were compared between the groups. Multivariate regression analysis was used to determine the relationship between factors related to difficult intubation and TTI.
RESULTS


The TTI was not different between the two groups. There were also no differences in the intubating profiles between the two groups. In both groups, the TTI was longer with a modified Mallampati score (mMS) of ≥3 and percentage of glottic opening (POGO) score of <50. In Group J, the TTI was longer with a body mass index (BMI) of ≥30 kg/m 2 .
CONCLUSION


The TTI during tracheal intubation with the MVL was not different between the two groups. The TTI was longer with an mMS of ≥3 and POGO score of <50. In Group J, the TTI was longer with a BMI of ≥30 kg/m 2 .",2020,"In both groups, the TTI was longer with a modified Mallampati score (mMS) of ≥3 and percentage of glottic opening (POGO) score of <50.",['Two hundred twenty-two patients undergoing surgery under general anesthesia'],"['60° and J-shaped stylets, for intubation using the McGrath MAC® video laryngoscope (MVL', 'McGrath MAC® video laryngoscope']","['intubating profiles', 'modified Mallampati score (mMS) of ≥3 and percentage of glottic opening (POGO) score', 'time to intubation (TTI) and other intubating profiles']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0183663', 'cui_str': 'Stylet'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451276', 'cui_str': 'Mallampati score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",222.0,0.0921774,"In both groups, the TTI was longer with a modified Mallampati score (mMS) of ≥3 and percentage of glottic opening (POGO) score of <50.","[{'ForeName': 'Hyunyoung', 'Initials': 'H', 'LastName': 'Lim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hanyang University Medical Centre, Hanyang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yun-Byeong', 'Initials': 'YB', 'LastName': 'Cha', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyoung-Ho', 'Initials': 'KH', 'LastName': 'Ryu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sung Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Eun-Ah', 'Initials': 'EA', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]",The Journal of international medical research,['10.1177/0300060520962951']
2434,33045886,Comparison of different end-tidal carbon dioxide levels in preventing postoperative nausea and vomiting in gynaecological patients undergoing laparoscopic surgery.,"The aim of this study was to compare different end-tidal carbon dioxide (EtCO 2 ) levels to prevent postoperative nausea and vomiting (PONV) caused by increased intracranial pressure due to pneumoperitoneum and Trendelenburg position in gynaecological laparoscopic surgery. A total of 60 female patients aged 25-50 years who would undergo laparoscopic gynaecological surgery under general anaesthesia were randomised into two groups: group A (EtCO 2 : 26 - 35 mmHg,  n  = 30) and group B (EtCO 2 : 36 - 45 mmHg,  n  = 30). In both groups, ONSD and EtCO 2  of the patients were measured at baseline after anaesthesia induction ( T   b ), at 5 min after pneumoperitoneum ( T   PP5 ), and at 10 min intervals after Trendelenburg position ( T   PP10 ,  T   PP20 ,  T   PP30 ). At 5 ( T   D5 ) and 10 min ( T   D10 ) after deflation, ONSD measurements were repeated. The incidence and severity of PONV of the patients, and antiemetic drugs used in both groups were assessed in the postoperative period. In the intraoperative follow-up periods,  T   PP5  and subsequent EtCO 2  values, as well as  T   PP10  and subsequent ONSD values, were significantly higher in group B and the incidence of nausea, the PONV scores and the incidence of rescue antiemetic use significantly lower in group A than in group B ( p <.001 for all). This result indicates that low EtCO 2  levels have beneficial effects on ICP and PONV in laparoscopic gynaecological operations. Impact statement  What is already known on this subject?  Laparoscopic gynaecologic surgery has been a more preferred technique. The incidence of postoperative nausea and vomiting (PONV) after laparoscopic gynaecologic surgery is remarkably high. In the prevention of PONV after gynaecologic laparoscopic surgery, single and multiple drug therapies and methods have been used.  What   the results of this study add?  Postoperative nausea and vomiting caused by intracranial pressure (ICP) increase due to carbon dioxide pneumoperitoneum and Trendelenburg position in gynaecologic laparoscopic surgeries were decreased in the early postoperative period by low end-tidal carbon dioxide levels in the intraoperative period. It was shown that low end-tidal carbon dioxide levels have beneficial effects on ICP and PONV in laparoscopic gynaecologic operations.  What   the implications   are   of these findings for clinical practice and/or further research?  This result indicates that low end-tidal carbon dioxide levels have beneficial effects on ICP and PONV in laparoscopic gynaecologic operations.",2020,(ICP) increase due to carbon dioxide pneumoperitoneum and Trendelenburg position in gynaecologic laparoscopic surgeries were decreased in the early postoperative period by low end-tidal carbon dioxide levels in the intraoperative period.,"['gynaecological patients undergoing laparoscopic surgery', 'gynaecological laparoscopic surgery', '60 female patients aged 25-50\xa0years who would undergo laparoscopic gynaecological surgery under general anaesthesia']","['tidal carbon dioxide (EtCO 2 ) levels', 'Laparoscopic gynaecologic surgery', 'different end-tidal carbon dioxide levels']","['ICP) increase due to carbon dioxide pneumoperitoneum and Trendelenburg position in gynaecologic laparoscopic surgeries', 'postoperative nausea and vomiting', 'intracranial pressure', 'T   PP10  and subsequent ONSD values', 'incidence and severity of PONV', 'postoperative nausea and vomiting (PONV', 'incidence of nausea, the PONV scores and the incidence of rescue antiemetic', 'Postoperative nausea and vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0277812', 'cui_str': 'Trendelenburg position'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}]",60.0,0.165992,(ICP) increase due to carbon dioxide pneumoperitoneum and Trendelenburg position in gynaecologic laparoscopic surgeries were decreased in the early postoperative period by low end-tidal carbon dioxide levels in the intraoperative period.,"[{'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Besir', 'Affiliation': 'Department of Anesthesiology and Critical Care, Faculty of Medicine, Karadeniz Technical University, Trabzon, Turkey.'}, {'ForeName': 'Ersagun', 'Initials': 'E', 'LastName': 'Tugcugil', 'Affiliation': 'Department of Anesthesiology and Critical Care, Faculty of Medicine, Karadeniz Technical University, Trabzon, Turkey.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2020.1789961']
2435,33045913,"A direct comparison of women's perceptions and acceptability of micronised progesterone and medroxyprogesterone acetate in combination with transdermal oestradiol in the management of young postmenopausal women, under 45 years of age.","OBJECTIVE


To assess the acceptability and perception of postmenopausal women, to two different hormone replacement therapy regimens, in relation to the control of their symptoms and development of adverse effects.
STUDY DESIGN


Prospectively recruited postmenopausal women, <45 years, were randomised to one of two treatment arms for 12-months: cyclical micronised progesterone or medroxyprogesterone acetate in combination with transdermal oestradiol. A self-reported questionnaire with matrix rating scales was completed and repeated after 3, 6 and 12-months.
MAIN OUTCOME MEASURES


Symptom control and development of adverse effects.
RESULTS


Seventy-one individuals were screened, with baseline data available for 67 subjects. A total of 190 questionnaires were returned. The most commonly reported symptoms were low energy levels, vasomotor symptoms and sexual dysfunction. The prevalence of adverse effects ranged between 57.89 and 87.50%, with a reduction seen in the transdermal oestradiol + micronised progesterone arm (73.91% at 3-months, decreasing to 57.89% at 12-months; p = 0.33), compared to the transdermal oestradiol + medroxyprogesterone acetate arm (76.92% at 3-months, increasing to 87.50% at 12-months; p = 0.69). The main reported adverse effects were bloating, weight change and psychological symptoms. A significant difference was documented between the groups after set intervals, with a greater proportion reporting breast tenderness after 3-months (p = 0.01), lower numbers reporting mood swings at 6-months (p = 0.01) and irritability at 12-months (p = 0.03) in the transdermal oestradiol + micronised progesterone arm compared to the transdermal oestradiol + medroxyprogesterone acetate arm.
CONCLUSIONS


The acceptability of both regimens was high despite adverse effects, but tolerability of transdermal oestradiol combined with micronised progesterone appeared to be better with fewer women reporting psychological concerns.",2020,"The prevalence of adverse effects ranged between 57.89 and 87.50%, with a reduction seen in the transdermal oestradiol + micronised progesterone arm (73.91% at 3-months, decreasing to 57.89% at 12-months; p = 0.33), compared to the transdermal oestradiol + medroxyprogesterone acetate arm (76.92% at 3-months, increasing to 87.50% at 12-months; p = 0.69).","['Prospectively recruited postmenopausal women, <45 years', 'Seventy-one individuals were screened, with baseline data available for 67 subjects', 'postmenopausal women', 'young postmenopausal women, under 45 years of age']","['cyclical micronised progesterone or medroxyprogesterone acetate in combination with transdermal oestradiol', 'micronised progesterone and medroxyprogesterone acetate', 'transdermal oestradiol\u2009+\u2009medroxyprogesterone acetate', 'medroxyprogesterone acetate', 'transdermal oestradiol combined with micronised progesterone', 'transdermal oestradiol']","['bloating, weight change and psychological symptoms', 'proportion reporting breast tenderness', 'irritability', 'prevalence of adverse effects', 'acceptability and perception', 'questionnaire with matrix rating scales', 'Symptom control and development of adverse effects', 'low energy levels, vasomotor symptoms and sexual dysfunction']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0262397', 'cui_str': 'Breast tenderness'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}]",190.0,0.0752755,"The prevalence of adverse effects ranged between 57.89 and 87.50%, with a reduction seen in the transdermal oestradiol + micronised progesterone arm (73.91% at 3-months, decreasing to 57.89% at 12-months; p = 0.33), compared to the transdermal oestradiol + medroxyprogesterone acetate arm (76.92% at 3-months, increasing to 87.50% at 12-months; p = 0.69).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mittal', 'Affiliation': ""Imperial College Healthcare NHS Trust, St Mary's and Hammersmith Hospitals, London, UK.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Panay', 'Affiliation': 'Imperial College Healthcare NHS Trust and Chelsea and Westminster NHS Foundation Trust, London, UK.'}, {'ForeName': 'P R', 'Initials': 'PR', 'LastName': 'Supramaniam', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Savvas', 'Affiliation': ""King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cardozo', 'Affiliation': ""King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hamoda', 'Affiliation': ""King's College Hospital NHS Foundation Trust, London, UK.""}]",Post reproductive health,['10.1177/2053369120960960']
2436,33046075,Effect of health education on knowledge and attitude of menopause among middle-age teachers.,"BACKGROUND


Adequate knowledge and positive attitude toward menopause are important for women to tackle changes related to menopause. Even though all women experience menopause at some stage in their life, teachers face more difficulties more than other female employees due to the nature of their roles do. In Eritrea, menopause has been given little attention hence gaps exist concerning women's knowledge, attitude, and the effects of health education on the same subject. This study aimed at assessing the effect of health education on knowledge and attitude of menopause among middle-aged teachers in elementary, junior, and secondary schools of Asmara, Eritrea.
METHOD


A semi-experimental design with pre-intervention, immediate post-intervention, and three-month follow up test was used in this study. The data was collected from 99 middle age teachers using stratified random sampling. The intervention was done using lectures, group discussions, brochures, and handouts. Data on socio-demographics, knowledge, and attitude was collected using a pre-designed questionnaire. The effect of educational training at the three-time points was evaluated by repeated measure ANOVA using SPSS version 22.
RESULTS


The mean scores of correct knowledge at pre-intervention, immediate post-intervention, and 3-months follow-up were 12.3/22 (SD = 3.06), 17.3/22 (SD = 3.21), and 16.5/22 (SD = 2.52) respectively. A significant difference in scores of knowledge at the three-time points was observed due to the educational intervention with a statistical significance of (p <  0.0001). Post-hoc analysis revealed that knowledge score immediately after intervention was significantly greater than that of pre-intervention (p <  0.0001), and 3-months follow-up (p = 0.004). The mean scores of attitude at the three-time points were 27.9/45 (SD = 5.14), 28.3/45(SD = 5.25), 28.32/45(SD = 5.12). The educational intervention had brought a change in the mean scores of attitude at the three-time point with a statistical significance of (p < 0.0001). Post-hoc analysis revealed that attitude scores at immediate post-intervention were also significant (p = 0.001) with the 3-months follow up at (p < 0.0001) were higher than that of pre-intervention.
CONCLUSION


The structured educational intervention was beneficial to the studied women in intensifying their knowledge and tuning them toward a positive attitude. Hence, proper health education programs regarding menopause are strongly recommended.",2020,The educational intervention had brought a change in the mean scores of attitude at the three-time point with a statistical significance of (p < 0.0001).,"['middle-aged teachers in elementary, junior, and secondary schools of Asmara, Eritrea', '99 middle age teachers using stratified random sampling', 'among middle-age teachers']","['health education', 'educational training', 'structured educational intervention']","['knowledge score', 'mean scores of correct knowledge', 'socio-demographics, knowledge, and attitude', 'attitude scores', 'knowledge and attitude of menopause', 'mean scores of attitude', 'scores of knowledge']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0014716', 'cui_str': 'Eritrea'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]",99.0,0.0226518,The educational intervention had brought a change in the mean scores of attitude at the three-time point with a statistical significance of (p < 0.0001).,"[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Gebretatyos', 'Affiliation': 'Department of Midwifery, School of Nursing, Asmara College of Health Sciences, Asmara, Eritrea. gebretatyoshelen@gmail.com.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Ghirmai', 'Affiliation': 'Department of Midwifery, School of Nursing, Asmara College of Health Sciences, Asmara, Eritrea.'}, {'ForeName': 'Soliana', 'Initials': 'S', 'LastName': 'Amanuel', 'Affiliation': 'Department of Midwifery, School of Nursing, Asmara College of Health Sciences, Asmara, Eritrea.'}, {'ForeName': 'Ghidey', 'Initials': 'G', 'LastName': 'Gebreyohannes', 'Affiliation': 'Dean of Asmara College of Health Sciences, Asmara, Eritrea.'}, {'ForeName': 'Zemenfes', 'Initials': 'Z', 'LastName': 'Tsighe', 'Affiliation': 'Dean of Asmara College of Health Sciences, Asmara, Eritrea.'}, {'ForeName': 'Eyasu H', 'Initials': 'EH', 'LastName': 'Tesfamariam', 'Affiliation': 'Department of Statistics, Biostatistics and Epidemiology Unit, College of Science, Mai Nefhi, Eritrea.'}]",BMC women's health,['10.1186/s12905-020-01095-2']
2437,33046094,A pilot cluster randomised trial of the medicines and alcohol consultation (MAC): an intervention to discuss alcohol use in community pharmacy medicine review services.,"BACKGROUND


Alcohol interventions are important to the developing public health role of community pharmacies. The Medicines and Alcohol Consultation (MAC) is a new intervention, co-produced with community pharmacists (CPs) and patients, which involves a CP practice development programme designed to integrate discussion of alcohol within existing NHS medicine review services. We conducted a pilot trial of the MAC and its delivery to investigate all study procedures to inform progression to a definitive trial.
METHODS


This cluster pilot RCT was conducted in 10 community pharmacies in Yorkshire, UK, with a CP from each who regularly conducted Medicine Use Review (MUR) and New Medicine Service (NMS) consultations. Randomisation was conducted using a secure remote randomisation service. Intervention CPs (n = 5) were trained to deliver the MAC in MUR/NMS consultations. Control CPs (n = 5) provided these services as usual. Consecutive MUR/NMS patients were asked by CPs to participate, screened for eligibility (consumption of alcohol at least twice per week), and baseline data collected for those eligible. A two-month follow-up telephone interview was conducted. Blinding of CPs was not possible, but patients were blinded to the alcohol focus of the trial. Primary outcomes were total weekly UK units (8 g of ethanol per unit) of alcohol consumption in the week prior to follow-up, and confidence in medications management. Trial procedures were assessed by recruitment, attrition, and follow-up rates.
RESULTS


260 patients were approached by CPs to take part in the trial, 68% (n = 178) were assessed for eligibility and 30% (n = 54) of these patients were eligible. Almost all eligible patients (n = 51; 94%) consented to participate, of whom 92% (n = 47) were followed-up at 2 months; alcohol consumption was lower in the intervention arm and confidence in medication management reduced slightly for both groups. Exploration of recall issues at follow-up showed a high level of agreement between a two-item quantity/frequency measure and 7-day guided recall of alcohol consumption.
CONCLUSIONS


The pilot trial demonstrates the feasibility of implementing the MAC in community pharmacy and trial recruitment and data collection procedures. However, decommissioning of MURs means that it is not possible to conduct a definitive trial of the intervention in this service.
TRIAL REGISTRATION


ISRCTN57447996.",2020,"Exploration of recall issues at follow-up showed a high level of agreement between a two-item quantity/frequency measure and 7-day guided recall of alcohol consumption.
","['260 patients were approached by CPs to take part in the trial, 68% (n\u2009=\u2009178) were assessed for eligibility and 30% (n\u2009=\u200954) of these patients were eligible', '10 community pharmacies in Yorkshire, UK, with a CP from each who regularly conducted Medicine Use Review (MUR) and New Medicine Service (NMS) consultations']","['MAC', 'Medicines and Alcohol Consultation (MAC', 'Control CPs', 'medicines and alcohol consultation (MAC']","['alcohol consumption', 'total weekly UK units (8\u2009g of ethanol per unit) of alcohol consumption in the week prior to follow-up, and confidence in medications management']","[{'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0402003', 'cui_str': 'Community pharmacist'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0402003', 'cui_str': 'Community pharmacist'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1318217', 'cui_str': '8G'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}]",260.0,0.0535451,"Exploration of recall issues at follow-up showed a high level of agreement between a two-item quantity/frequency measure and 7-day guided recall of alcohol consumption.
","[{'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Stewart', 'Affiliation': 'Department of Health Sciences, University of York, York, UK. d.stewart@londonmet.ac.uk.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'van Dongen', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Watson', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mandefield', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Atkin', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Ranjita', 'Initials': 'R', 'LastName': 'Dhital', 'Affiliation': 'Department of Pharmacy, University of Reading, Reading, UK.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Foster', 'Affiliation': 'Whitworths Chemists Ltd, Scunthorpe, UK.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Gough', 'Affiliation': 'School of Social Sciences, Leeds Beckett University, Leeds, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Madden', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': ""O'Carroll"", 'Affiliation': 'Department of Psychology, Stirling University, Stirling, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Ogden', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Watson', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'White', 'Affiliation': 'North of England Commissioning Support (NECS), Newcastle, UK.'}, {'ForeName': 'Cate', 'Initials': 'C', 'LastName': 'Whittlesea', 'Affiliation': 'UCL School of Pharmacy, University College London, London, UK.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'McCambridge', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}]",BMC health services research,['10.1186/s12913-020-05797-z']
2438,33046115,The effect of breastfeeding education with grandmothers' attendance on breastfeeding self-efficacy and infant feeding pattern in Iranian primiparous women: a quasi-experimental pilot study.,"BACKGROUND


One of the most important factors that affects breastfeeding self-efficacy and exclusivity is breastfeeding support provided by the family. The aim of this study was to determine the effect of breastfeeding education sessions for primiparous women, with and without the attendance of maternal grandmothers, on breastfeeding self-efficacy and infant feeding patterns.
METHODS


This quasi-experimental study was conducted on 64 primiparous women who referred to the Antenatal Clinic of Amiralmomenin Hospital, Tehran, Iran from June to December, 2018. Eligible pregnant women were allocated into two groups; either with and without grandmothers in attendance. Group assignments were determined according to the week the women had prenatal care at the hospital. All eligible women seen in the clinic during 1 week were assigned to one group and women who presented in the alternating week were assigned to the other group. In the education group with grandmothers in attendance, each woman participated in two prenatal education programs with her mother and one postpartum program approximately 3 h before discharge. In the other group, participating mothers attended breastfeeding education sessions without the grandmother's attendance. The participating mothers answered questions from the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) at the time of the hospital discharge, and 4 and 8 weeks after delivery. Questions about the infants' feeding patterns were asked by telephone contact with the participating mothers from both groups at the same time periods.
RESULTS


The mean BFSE scores were signficantly different between the groups with grandmothers and without grandmothers at the time of the hospital discharge (60.15 ± 4.47 vs. 56.84 ± 6.22, independent t-test; p = 0.017), and at 4 weeks (61.71 ± 2.66 vs. 56.62 ± 9.12, p = 0.004) and 8 weeks after delivery (63.68 ± 2.14 vs. 60.03 ± 6.32, p = 0.003). No significant difference existed in infant feeding patterns between the groups at the same time periods.
CONCLUSIONS


This study suggests that breastfeeding education with grandmothers' attendance is effective in improving the mothers' breastfeeding self-efficacy. A family-centered program should be considered in beastfeeding education for increasing of exclusive breastfeeding.",2020,"The mean BFSE scores were signficantly different between the groups with grandmothers and without grandmothers at the time of the hospital discharge (60.15 ± 4.47 vs. 56.84 ± 6.22, independent t-test; p = 0.017), and at 4 weeks (61.71 ± 2.66 vs. 56.62 ± 9.12, p = 0.004) and 8 weeks after delivery (63.68 ± 2.14 vs. 60.03 ± 6.32, p = 0.003).","['Eligible pregnant women', '64 primiparous women who referred to the Antenatal Clinic of Amiralmomenin Hospital, Tehran, Iran from June to December, 2018', 'Iranian primiparous women', 'primiparous women, with and without the attendance of maternal grandmothers, on breastfeeding self-efficacy and infant feeding patterns', 'All eligible women seen in the clinic during 1 week were assigned to one group and women who presented in the alternating week were assigned to the other group']","[""breastfeeding education with grandmothers' attendance"", 'breastfeeding education sessions']","['infant feeding patterns', 'mean BFSE scores', 'Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1273525', 'cui_str': 'Maternal grandmother'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1286340', 'cui_str': 'Infant feeding pattern'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}]","[{'cui': 'C0418914', 'cui_str': 'Breastfeeding education'}, {'cui': 'C0337474', 'cui_str': 'Grandmother'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]","[{'cui': 'C1286340', 'cui_str': 'Infant feeding pattern'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",64.0,0.0233771,"The mean BFSE scores were signficantly different between the groups with grandmothers and without grandmothers at the time of the hospital discharge (60.15 ± 4.47 vs. 56.84 ± 6.22, independent t-test; p = 0.017), and at 4 weeks (61.71 ± 2.66 vs. 56.62 ± 9.12, p = 0.004) and 8 weeks after delivery (63.68 ± 2.14 vs. 60.03 ± 6.32, p = 0.003).","[{'ForeName': 'Tayebeh', 'Initials': 'T', 'LastName': 'Gharaei', 'Affiliation': 'Department of Reproductive Health and Midwifery, Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Amiri-Farahani', 'Affiliation': 'Department of Reproductive Health and Midwifery, Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran. amirifarahani.l@iums.ac.ir.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Haghani', 'Affiliation': 'Department of Biostatistics, Nursing Care Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Syedeh Batool', 'Initials': 'SB', 'LastName': 'Hasanpoor-Azghady', 'Affiliation': 'Department of Reproductive Health and Midwifery, Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}]",International breastfeeding journal,['10.1186/s13006-020-00325-5']
2439,33046128,The prophylactic and therapeutic effects of moxibustion combined with traditional Chinese medicine decoction for treating chemotherapy-induced myelosuppression in early-stage breast cancer: study protocol for a randomized controlled trial.,"BACKGROUND


Traditional Chinese medicine (TCM) has a long history of use in breast cancer, but lacking systematic evidence to support its clinical benefits. In this study, we evaluated the prophylactic and therapeutic effects of moxibustion combined with decoctions for treating chemotherapy-induced myelosuppression (CIM) in early-stage breast cancer patients.
METHODS


This is a randomized controlled clinical trial single-blinded for TCM decoction but not moxibustion. Patients are equally divided into the control group without decoction and moxibustion treatment (control), the decoction+moxibustion group (MD), and the placebo+moxibustion group (MP), according to the following stratification factors: age (below 40s, 40s, 50s, and 60s or above), chemotherapy regimen (anthracyclines, taxanes, anthracyclines+taxane, and others), and chemotherapy strategy (adjuvant and neoadjuvant). The TCM decoction is Wenshen Shengbai Decoction. The anticipated sample size is 462 cases (154 cases in each group). All participants are expected to treat with chemotherapy and recombinant human granulocyte colony-stimulating factor (rhG-CSF). The primary outcomes include the proportion of patients with relief of leukopenia and/or neutropenia, the myelosuppression-associated serious adverse event including grade 3-4 leukopenia and/or neutropenia, and febrile neutropenia, and the dose of rhG-CSF. The secondary outcomes include chemotherapy adherence, stratified analysis, adverse reactions, quality of life by EORTC Breast-Cancer-Specific Quality of Life Questionnaire including EORTC QLQ-C30 (V3.0) and QLQ-BR23, TCM Constitution, and 3-year disease-free survival and overall survival. Baseline information including age, surgical approach, chemotherapy regimen and strategy, pathological stage, and molecular subtype will be recorded.
DISCUSSION


This will be the first randomized controlled trial to evaluate the efficacy of moxibustion combined with TCM decoction in treating CIM in early-stage breast cancer patients, aiming to standardize the TCM decoction and moxibustion method, thus providing evidence for its clinical benefit.
TRIAL REGISTRATION


chictr.org.cn ChiCTR-INR-16009557 . Registered on 23 October 2016.",2020,"This will be the first randomized controlled trial to evaluate the efficacy of moxibustion combined with TCM decoction in treating CIM in early-stage breast cancer patients, aiming to standardize the TCM decoction and moxibustion method, thus providing evidence for its clinical benefit.
","['early-stage breast cancer', 'early-stage breast cancer patients']","['moxibustion combined with traditional Chinese medicine decoction', 'Traditional Chinese medicine (TCM', 'chemotherapy regimen (anthracyclines, taxanes, anthracyclines+taxane, and others), and chemotherapy strategy (adjuvant and neoadjuvant', 'moxibustion combined with decoctions', 'TCM decoction', 'control group without decoction and moxibustion treatment (control), the decoction+moxibustion group (MD), and the placebo+moxibustion group (MP', 'chemotherapy and recombinant human granulocyte colony-stimulating factor (rhG-CSF', 'moxibustion combined with TCM decoction']","['myelosuppression (CIM', 'chemotherapy adherence, stratified analysis, adverse reactions, quality of life by EORTC Breast-Cancer-Specific Quality of Life Questionnaire including EORTC QLQ-C30 (V3.0) and QLQ-BR23, TCM Constitution, and 3-year disease-free survival and overall survival', 'proportion of patients with relief of leukopenia and/or neutropenia, the myelosuppression-associated serious adverse event including grade 3-4 leukopenia and/or neutropenia, and febrile neutropenia, and the dose of rhG-CSF']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1271481', 'cui_str': 'Recombinant human granulocyte colony stimulating factor'}]","[{'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0009807', 'cui_str': 'Constitution'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1271481', 'cui_str': 'Recombinant human granulocyte colony stimulating factor'}]",,0.235249,"This will be the first randomized controlled trial to evaluate the efficacy of moxibustion combined with TCM decoction in treating CIM in early-stage breast cancer patients, aiming to standardize the TCM decoction and moxibustion method, thus providing evidence for its clinical benefit.
","[{'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Xinyue', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Sheng', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Jiang', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Shanyan', 'Initials': 'S', 'LastName': 'Sha', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Mengting', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Zongxin', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Peiyi', 'Initials': 'P', 'LastName': 'Zheng', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Minhong', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Huangan', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China.'}, {'ForeName': 'Huirong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China.'}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Xue', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China. 195641459@qq.com.'}]",Trials,['10.1186/s13063-020-04749-6']
2440,33048904,The Effects of Melatonin Supplementation on Sleep Quality and Assessment of the Serum Melatonin in ICU Patients: A Randomized Controlled Trial.,"OBJECTIVES


To evaluate whether the use of exogenous melatonin affects sleep, reduces the prevalence of delirium, and decreases the need for analgosedation and to assess whether serum melatonin indices correlate with exogenous administration in critically ill patients.
DESIGN


Double-blind, randomized, placebo-controlled study.
SETTING


Multicenter ICUs of two tertiary hospitals.
PATIENTS


A total of 203 adult patients who were admitted to the ICU and administered with analgesics and/or sedatives.
INTERVENTIONS


Oral melatonin (10 mg) or placebo for up to seven consecutive nights.
MEASUREMENTS AND MAIN RESULTS


The number of observed sleeping hours at night was assessed by the bedside nurse. Sleep quality was evaluated using the Richards Campbell Questionnaire Sleep (RCSQ). The prevalence of delirium, pain, anxiety, adverse reactions, duration of mechanical ventilation, length of ICU and hospital stays, and doses of sedative and analgesic drugs administered were recorded. The use of analgesics and sedatives was assessed daily. Melatonin levels were determined by enzyme-linked immunosorbent assay. Based on the RCSQ results, sleep quality was assessed to be better in the melatonin group than that in the placebo group with a mean (SD) of 69.7 (21.2) and 60.7 (26.3), respectively (p = 0.029). About 45.8% and 34.4% of participants in the melatonin and placebo groups had very good sleep (risk ratio, 1.33; 95% CI, 0.94-1.89), whereas 3.1% and 14.6% had very poor sleep (risk ratio, 0.21; 95% CI, 0.06-0.71), respectively. No significant difference was observed regarding the days free of analgesics or sedatives, the duration of night sleep, and the occurrence of delirium, pain, and anxiety. Melatonin serum peak levels at 2 AM were 150 pg/mL (range, 125-2,125 pg/mL) in the melatonin group and 32.5 pg/mL (range, 18.5-35 pg/mL) in the placebo group (p < 0.001).
CONCLUSIONS


Melatonin was associated with better sleep quality, which suggests its possible role in the routine care of critically ill patients in the future.",2020,"placebo groups had very good sleep (risk ratio, 1.33; 95% CI, 0.94-1.89), whereas 3.1% and 14.6% had very poor sleep (risk ratio, 0.21; 95% CI, 0.06-0.71), respectively.","['203 adult patients who were admitted to the ICU and administered with analgesics and/or sedatives', 'Multicenter ICUs of two tertiary hospitals', 'ICU Patients', 'critically ill patients']","['melatonin', 'Melatonin Supplementation', 'exogenous melatonin', 'placebo', 'Oral melatonin', 'Melatonin']","['Campbell Questionnaire Sleep (RCSQ', 'good sleep', 'days free of analgesics or sedatives, the duration of night sleep, and the occurrence of delirium, pain, and anxiety', 'Melatonin serum peak levels', 'Melatonin levels', 'prevalence of delirium, pain, anxiety, adverse reactions, duration of mechanical ventilation, length of ICU and hospital stays, and doses of sedative and analgesic drugs', 'Sleep quality', 'Sleep Quality and Assessment of the Serum Melatonin', 'sleep quality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",203.0,0.558056,"placebo groups had very good sleep (risk ratio, 1.33; 95% CI, 0.94-1.89), whereas 3.1% and 14.6% had very poor sleep (risk ratio, 0.21; 95% CI, 0.06-0.71), respectively.","[{'ForeName': 'Joelma Villafanha', 'Initials': 'JV', 'LastName': 'Gandolfi', 'Affiliation': 'Intensive Care Unit, Hospital de Base and São José do Rio Preto Medical School, São José do Rio Preto, Brazil.'}, {'ForeName': 'Ana Paula Altimari', 'Initials': 'APA', 'LastName': 'Di Bernardo', 'Affiliation': 'Intensive Care Unit, Hospital de Base and São José do Rio Preto Medical School, São José do Rio Preto, Brazil.'}, {'ForeName': 'Débora Augusto Valverde', 'Initials': 'DAV', 'LastName': 'Chanes', 'Affiliation': 'Intensive Care Unit, Hospital de Base and São José do Rio Preto Medical School, São José do Rio Preto, Brazil.'}, {'ForeName': 'Danilo Fernando', 'Initials': 'DF', 'LastName': 'Martin', 'Affiliation': 'Cardiologic Intensive Care Unit, Hospital de Base and São José do Rio Preto Medical School, São José do Rio Preto, Brazil.'}, {'ForeName': 'Vanessa Bonafim', 'Initials': 'VB', 'LastName': 'Joles', 'Affiliation': 'Cardiologic Intensive Care Unit, Hospital de Base and São José do Rio Preto Medical School, São José do Rio Preto, Brazil.'}, {'ForeName': 'Cristina Prata', 'Initials': 'CP', 'LastName': 'Amendola', 'Affiliation': 'Pio XII Foundation, Hospital do Câncer de Barretos, Barretos, Brazil.'}, {'ForeName': 'Luciana Coelho', 'Initials': 'LC', 'LastName': 'Sanches', 'Affiliation': 'Pio XII Foundation, Hospital do Câncer de Barretos, Barretos, Brazil.'}, {'ForeName': 'Gustavo Larsen', 'Initials': 'GL', 'LastName': 'Ciorlia', 'Affiliation': 'Pio XII Foundation, Hospital do Câncer de Barretos, Barretos, Brazil.'}, {'ForeName': 'Suzana Margareth', 'Initials': 'SM', 'LastName': 'Lobo', 'Affiliation': 'Intensive Care Unit, Hospital de Base and São José do Rio Preto Medical School, São José do Rio Preto, Brazil.'}]",Critical care medicine,['10.1097/CCM.0000000000004690']
2441,33048906,Effect of Nurse-Led Consultations on Post-Traumatic Stress and Sense of Coherence in Discharged ICU Patients With Clinically Relevant Post-Traumatic Stress Symptoms-A Randomized Controlled Trial.,"OBJECTIVES


To investigate the effect of nurse-led consultations on reducing post-traumatic stress symptoms and increasing sense of coherence in discharged ICU patients with clinically relevant post-traumatic stress symptoms and to identify variables associated with symptoms 12 months later.
DESIGN


A pragmatic nonblinded randomized controlled trial.
SETTINGS


Five surgical and medical ICUs at Oslo University Hospital.
PATIENTS


Adult patients treated in the ICU greater than or equal to 24 hours were screened with Post-Traumatic Stress Scale 10 intensive part B after ICU discharge. Those scoring greater than or equal to 25 were included in the study.
INTERVENTION


Patients randomized to intervention group were offered three nurse-led consultations within 2 months, and patients in the control group received standard care.
MEASUREMENTS AND MAIN RESULTS


Sense of Coherence Scale 13 and Post-Traumatic Stress Scale 10 intensive part B were completed after inclusion, and reevaluated after 3, 6, and 12 months. Linear mixed model for repeated measures and linear regression analyses were performed. Among 523 screened patients, 111 and 113 were randomized to intervention group and control group, respectively. Mean Post-Traumatic Stress Scale 10 intensive part B score was 37 (±10) before randomization. No differences in post-traumatic stress symptoms or sense of coherence were found between intervention group versus control group, with a mean Post-Traumatic Stress Scale 10 intensive part B score 39 (95% CI, 37-41) versus 37 (95% CI, 35-39), 32 (95% CI, 28-35) versus 32 (95% CI, 29-35), 31 (95% CI, 28-34) versus 30 (95% CI, 27-33), and 31 (95% CI, 28-34) versus 29 (95% CI, 26-33) at baseline, 3, 6, and 12 months, respectively. There was a significantly reduced Post-Traumatic Stress Scale 10 intensive part B score for both groups during the year (p = 0.001). Low sense of coherence, pain, and previous psychiatric problems were associated with increased level of post-traumatic stress symptoms at 12 months.
CONCLUSIONS


Nurse-led consultations did not reveal any significant effect on post-traumatic stress symptoms or sense of coherence after ICU discharge in patients with clinically relevant symptoms.",2020,"CONCLUSIONS


Nurse-led consultations did not reveal any significant effect on post-traumatic stress symptoms or sense of coherence after ICU discharge in patients with clinically relevant symptoms.","['discharged ICU patients with clinically relevant post-traumatic stress symptoms', 'Five surgical and medical ICUs at Oslo University Hospital', '523 screened patients, 111 and 113', 'Discharged ICU Patients With Clinically Relevant Post-Traumatic Stress Symptoms', 'Adult patients treated in the ICU greater than or equal to 24 hours were screened with Post-Traumatic Stress Scale 10 intensive part B after ICU discharge', 'patients with clinically relevant symptoms']","['control group received standard care', 'nurse-led consultations', 'Nurse-Led Consultations']","['level of post-traumatic stress symptoms', 'mean Post-Traumatic Stress Scale 10 intensive part B score', 'Mean Post-Traumatic Stress Scale 10 intensive part B score', 'Sense of Coherence Scale 13 and Post-Traumatic Stress Scale 10 intensive part B', 'Post-Traumatic Stress Scale 10 intensive part B score', 'post-traumatic stress symptoms or sense of coherence', 'Low sense of coherence, pain, and previous psychiatric problems', 'Post-Traumatic Stress and Sense of Coherence']","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3178983', 'cui_str': 'Salutogenesis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",523.0,0.121023,"CONCLUSIONS


Nurse-led consultations did not reveal any significant effect on post-traumatic stress symptoms or sense of coherence after ICU discharge in patients with clinically relevant symptoms.","[{'ForeName': 'Åse', 'Initials': 'Å', 'LastName': 'Valsø', 'Affiliation': ''}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Rustøen', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Research and Development, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Milada Cvancarova', 'Initials': 'MC', 'LastName': 'Småstuen', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Research and Development, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Ekeberg', 'Affiliation': 'Division of Mental Health and Addiction, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Skogstad', 'Affiliation': 'Department of Research, Sunnaas Rehabilitation Hospital, Bjørnemyr, Norway.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Schou-Bredal', 'Affiliation': 'Faculty of Medicine, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Myhren', 'Affiliation': 'Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kjetil', 'Initials': 'K', 'LastName': 'Sunde', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Anesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kirsti', 'Initials': 'K', 'LastName': 'Tøien', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Postoperative and Intensive Care, Oslo University Hospital, Oslo, Norway.'}]",Critical care medicine,['10.1097/CCM.0000000000004628']
2442,33048923,Evaluation of a pharmacist-led actionable audit and feedback intervention for improving medication safety in UK primary care: An interrupted time series analysis.,"BACKGROUND


We evaluated the impact of the pharmacist-led Safety Medication dASHboard (SMASH) intervention on medication safety in primary care.
METHODS AND FINDINGS


SMASH comprised (1) training of clinical pharmacists to deliver the intervention; (2) a web-based dashboard providing actionable, patient-level feedback; and (3) pharmacists reviewing individual at-risk patients, and initiating remedial actions or advising general practitioners on doing so. It was implemented in 43 general practices covering a population of 235,595 people in Salford (Greater Manchester), UK. All practices started receiving the intervention between 18 April 2016 and 26 September 2017. We used an interrupted time series analysis of rates (prevalence) of potentially hazardous prescribing and inadequate blood-test monitoring, comparing observed rates post-intervention to extrapolations from a 24-month pre-intervention trend. The number of people registered to participating practices and having 1 or more risk factors for being exposed to hazardous prescribing or inadequate blood-test monitoring at the start of the intervention was 47,413 (males: 23,073 [48.7%]; mean age: 60 years [standard deviation: 21]). At baseline, 95% of practices had rates of potentially hazardous prescribing (composite of 10 indicators) between 0.88% and 6.19%. The prevalence of potentially hazardous prescribing reduced by 27.9% (95% CI 20.3% to 36.8%, p < 0.001) at 24 weeks and by 40.7% (95% CI 29.1% to 54.2%, p < 0.001) at 12 months after introduction of SMASH. The rate of inadequate blood-test monitoring (composite of 2 indicators) reduced by 22.0% (95% CI 0.2% to 50.7%, p = 0.046) at 24 weeks; the change at 12 months (23.5%) was no longer significant (95% CI -4.5% to 61.6%, p = 0.127). After 12 months, 95% of practices had rates of potentially hazardous prescribing between 0.74% and 3.02%. Study limitations include the fact that practices were not randomised, and therefore unmeasured confounding may have influenced our findings.
CONCLUSIONS


The SMASH intervention was associated with reduced rates of potentially hazardous prescribing and inadequate blood-test monitoring in general practices. This reduction was sustained over 12 months after the start of the intervention for prescribing but not for monitoring of medication. There was a marked reduction in the variation in rates of hazardous prescribing between practices.",2020,"After 12 months, 95% of practices had rates of potentially hazardous prescribing between 0.74% and 3.02%.","['47,413 (males: 23,073 [48.7%]; mean age: 60 years [standard deviation: 21', '43 general practices covering a population of 235,595 people in Salford (Greater Manchester), UK', 'UK primary care']","['pharmacist-led actionable audit and feedback intervention', 'clinical pharmacists to deliver the intervention; (2) a web-based dashboard providing actionable, patient-level feedback; and (3) pharmacists reviewing individual at-risk patients, and initiating remedial actions or advising general practitioners on doing so', 'pharmacist-led Safety Medication dASHboard (SMASH) intervention']","['rate of inadequate blood-test monitoring (composite of 2 indicators', 'reduced rates of potentially hazardous prescribing and inadequate blood-test monitoring', 'prevalence of potentially hazardous prescribing', 'rates of potentially hazardous prescribing']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0454856', 'cui_str': 'Greater Manchester'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1449564', 'cui_str': 'Clinical pharmacist'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",235595.0,0.163888,"After 12 months, 95% of practices had rates of potentially hazardous prescribing between 0.74% and 3.02%.","[{'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Peek', 'Affiliation': 'NIHR Greater Manchester Patient Safety Translational Research Centre, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Wouter T', 'Initials': 'WT', 'LastName': 'Gude', 'Affiliation': 'Department of Medical Informatics, Amsterdam UMC, Amsterdam Public Health Research Institute, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Keers', 'Affiliation': 'NIHR Greater Manchester Patient Safety Translational Research Centre, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'NIHR Greater Manchester Patient Safety Translational Research Centre, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Kontopantelis', 'Affiliation': 'NIHR School for Primary Care Research, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jeffries', 'Affiliation': 'NIHR Greater Manchester Patient Safety Translational Research Centre, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Denham L', 'Initials': 'DL', 'LastName': 'Phipps', 'Affiliation': 'NIHR Greater Manchester Patient Safety Translational Research Centre, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Brown', 'Affiliation': 'NIHR Greater Manchester Patient Safety Translational Research Centre, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Avery', 'Affiliation': 'NIHR Greater Manchester Patient Safety Translational Research Centre, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Darren M', 'Initials': 'DM', 'LastName': 'Ashcroft', 'Affiliation': 'NIHR Greater Manchester Patient Safety Translational Research Centre, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}]",PLoS medicine,['10.1371/journal.pmed.1003286']
2443,33048964,Facemask against viral respiratory infections among Hajj pilgrims: A challenging cluster-randomized trial.,"BACKGROUND


In this large-scale cluster-randomized controlled trial (cRCT) we sought to assess the effectiveness of facemasks against viral respiratory infections.
METHODS AND RESULTS


Over three consecutive Hajj seasons (2013, 2014, 2015) pilgrims' tents in Makkah were allocated to 'facemask' or 'no facemask' group. Fifty facemasks were offered to participants in intervention tents, to be worn over four days, and none were offered to participants in control tents. All participants recorded facemask use and respiratory symptoms in health diaries. Nasal swabs were collected from the symptomatic for virus detection by reverse transcription polymerase chain reaction. Clinical symptoms and laboratory results were analyzed by 'intention- to-treat' and 'per-protocol'. A total of 7687 adult participants from 318 tents were randomized: 3864 from 149 tents to the intervention group, and 3823 from 169 tents to the control group. Participants were aged 18 to 95 (median 34, mean 37) years, with a male to female ratio of 1:1.2. Overall, respiratory viruses were detected in 277 of 650 (43%) nasal/pharyngeal swabs collected from symptomatic pilgrims. Common viruses were rhinovirus (35.1%), influenza (4.5%) and parainfluenza (1.7%). In the intervention arm, respectively 954 (24.7%) and 1842 (47.7%) participants used facemasks daily and intermittently, while in the control arm, respectively 546 (14.3%) and 1334 (34.9%) used facemasks daily and intermittently. By intention-to-treat analysis, facemask use did not seem to be effective against laboratory-confirmed viral respiratory infections (odds ratio [OR], 1.4; 95% confidence interval [CI], 0.9 to 2.1, p = 0.18) nor against clinical respiratory infection (OR, 1.1; 95% CI, 0.9 to 1.4, p = 0.40). Similarly, in a per-protocol analysis, facemask use did not seem to be effective against laboratory-confirmed viral respiratory infections (OR 1.2, 95% CI 0.9-1.7, p = 0.26) nor against clinical respiratory infection (OR 1.3, 95% CI 1.0-1.8, p = 0.06).
CONCLUSION


This trial was unable to provide conclusive evidence on facemask efficacy against viral respiratory infections most likely due to poor adherence to protocol.",2020,"By intention-to-treat analysis, facemask use did not seem to be effective against laboratory-confirmed viral respiratory infections (odds ratio [OR], 1.4; 95% confidence interval [CI], 0.9 to 2.1, p = 0.18) nor against clinical respiratory infection (OR, 1.1; 95% CI, 0.9 to 1.4, p = 0.40).","['Hajj pilgrims', 'Participants were aged 18 to 95 (median 34, mean 37) years, with a male to female ratio of 1:1.2', '7687 adult participants from 318 tents were randomized: 3864 from 149 tents to the intervention group, and 3823 from 169 tents to the control group']","[""facemask' or 'no facemask' group"", 'Facemask']","['clinical respiratory infection', 'facemask use and respiratory symptoms in health diaries', 'Overall, respiratory viruses', 'effective against laboratory-confirmed viral respiratory infections']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677506', 'cui_str': 'Tent'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0018700', 'cui_str': 'Health Diaries'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0597404', 'cui_str': 'Respiratory viruses'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0729531', 'cui_str': 'Viral respiratory infection'}]",7687.0,0.198261,"By intention-to-treat analysis, facemask use did not seem to be effective against laboratory-confirmed viral respiratory infections (odds ratio [OR], 1.4; 95% confidence interval [CI], 0.9 to 2.1, p = 0.18) nor against clinical respiratory infection (OR, 1.1; 95% CI, 0.9 to 1.4, p = 0.40).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Alfelali', 'Affiliation': ""National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead and The University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Haworth', 'Affiliation': 'Menzies Institute for Medical Research Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Osamah', 'Initials': 'O', 'LastName': 'Barasheed', 'Affiliation': ""National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead and The University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Al-Mamoon', 'Initials': 'AM', 'LastName': 'Badahdah', 'Affiliation': ""National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead and The University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Bokhary', 'Affiliation': 'Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Life & Environmental Sciences and School of Medical Sciences, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Tashani', 'Affiliation': ""Discipline of Child and Adolescent Health, The Children's Hospital at Westmead Clinical School, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Mohammad I', 'Initials': 'MI', 'LastName': 'Azeem', 'Affiliation': ""National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead and The University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Jen', 'Initials': 'J', 'LastName': 'Kok', 'Affiliation': 'Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Life & Environmental Sciences and School of Medical Sciences, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Janette', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'NSW Health Pathology - Institute for Clinical Pathology and Medical Research, Westmead Hospital and The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Barnes', 'Affiliation': 'NHMRC Clinical Trials Centre, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'El Bashir', 'Affiliation': 'Rehabilitation Department, Al Jalila Children Specialty Hospital, Dubai, United Arab Emirates.'}, {'ForeName': 'Gulam', 'Initials': 'G', 'LastName': 'Khandaker', 'Affiliation': ""Discipline of Child and Adolescent Health, The Children's Hospital at Westmead Clinical School, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Holmes', 'Affiliation': 'Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Life & Environmental Sciences and School of Medical Sciences, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dominic E', 'Initials': 'DE', 'LastName': 'Dwyer', 'Affiliation': 'Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Life & Environmental Sciences and School of Medical Sciences, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Leon G', 'Initials': 'LG', 'LastName': 'Heron', 'Affiliation': ""National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead and The University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Godwin J', 'Initials': 'GJ', 'LastName': 'Wilson', 'Affiliation': 'Department of Laboratory Medicine, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Booy', 'Affiliation': ""National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead and The University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Harunor', 'Initials': 'H', 'LastName': 'Rashid', 'Affiliation': ""National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead and The University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0240287']
2444,33048991,"Correction: High intensity, circuit-type integrated neuromuscular training alters energy balance and reduces body mass and fat in obese women: A 10-month training-detraining randomized controlled trial.",[This corrects the article DOI: 10.1371/journal.pone.0202390.].,2020,[This corrects the article DOI: 10.1371/journal.pone.0202390.].,['obese women'],['circuit-type integrated neuromuscular training alters energy balance'],[],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",[],,0.0641754,[This corrects the article DOI: 10.1371/journal.pone.0202390.].,"[{'ForeName': 'Alexios', 'Initials': 'A', 'LastName': 'Batrakoulis', 'Affiliation': ''}, {'ForeName': 'Athanasios Z', 'Initials': 'AZ', 'LastName': 'Jamurtas', 'Affiliation': ''}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Georgakouli', 'Affiliation': ''}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Draganidis', 'Affiliation': ''}, {'ForeName': 'Chariklia K', 'Initials': 'CK', 'LastName': 'Deli', 'Affiliation': ''}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Papanikolaou', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Avloniti', 'Affiliation': ''}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Chatzinikolaou', 'Affiliation': ''}, {'ForeName': 'Diamanda', 'Initials': 'D', 'LastName': 'Leontsini', 'Affiliation': ''}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Tsimeas', 'Affiliation': ''}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Comoutos', 'Affiliation': ''}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Bouglas', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Michalopoulou', 'Affiliation': ''}, {'ForeName': 'Ioannis G', 'Initials': 'IG', 'LastName': 'Fatouros', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0240945']
2445,33049119,Randomized Pilot Trial of Ipratropium versus Placebo in Children with Critical Asthma.,"OBJECTIVE


To test the effects of inhaled ipratropium on clinical outcomes of critical asthma in the first randomized trial of this adjunctive therapy in critically ill children.
DESIGN


Pilot, placebo-controlled, double blinded, randomized controlled trial PATIENTS: Thirty children (15/group) with critical asthma receiving high-intensity albuterol per a standardized pathway utilizing objective assessments to wean patients to less frequent albuterol administration.
INTERVENTIONS


Subjects were randomized to receive either nebulized ipratropium bromide (500µg in 0.9% saline per dose) or an equivalent volume of nebulized 0.9% saline every 6 hours until the patient was successfully weaned to albuterol doses every 2 hours (""q2 albuterol"").
MEASUREMENTS AND MAIN RESULTS


Demographics, initial clinical severity score, and asthma histories were similar between groups. There was no significant difference in median duration of high intensity albuterol between the treatment group (17.5 [10.3-22.1] hours) and placebo group (14.6 [12.7-24.5] days; p = 0.56). Similarly, there was no significant difference in PICU length of stay (22.6 [21.1-33.6] vs. 21.4 [16.1-35.8] hours; p = 0.74) or hospital length of stay (48.0 [41.8-59.8] vs. 47.3 [37.2-63.1] hours; p = 0.67). In multivariate linear regression adjusting for identified confounders, treatment with ipratropium was not significantly associated with any of the three outcomes. Side effects were rare and occurred with equally between both groups CONCLUSIONS: Adjunctive therapy with ipratropium was not associated with decreased duration of high intensity albuterol or shortened length of stay when compared to placebo. A larger, multicenter trial is warranted to confirm that ipratropium does not improve clinical outcomes. This article is protected by copyright. All rights reserved.",2020,Adjunctive therapy with ipratropium was not associated with decreased duration of high intensity albuterol or shortened length of stay when compared to placebo.,"['critically ill children', 'Thirty children (15/group) with critical asthma receiving high-intensity albuterol per a standardized pathway utilizing objective assessments to wean patients to less frequent albuterol administration', 'Children with Critical Asthma']","['nebulized ipratropium bromide (500µg in 0.9% saline per dose) or an equivalent volume of nebulized 0.9% saline', 'placebo', 'ipratropium', 'Ipratropium', 'inhaled ipratropium', 'Placebo']","['median duration of high intensity albuterol', 'PICU length of stay', 'duration of high intensity albuterol or shortened length of stay', 'hospital length of stay', 'Demographics, initial clinical severity score, and asthma histories']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0700580', 'cui_str': 'ipratropium bromide'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027235', 'cui_str': 'Ipratropium'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0019664', 'cui_str': 'History'}]",,0.615042,Adjunctive therapy with ipratropium was not associated with decreased duration of high intensity albuterol or shortened length of stay when compared to placebo.,"[{'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Murphy', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio.""}, {'ForeName': 'Nabihah', 'Initials': 'N', 'LastName': 'Mahmood', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Craven', 'Affiliation': ""Division of Pediatric Pulmonology, Rainbow Babies and Children's Hospital, Cleveland, Ohio.""}, {'ForeName': 'Rrt', 'Initials': 'R', 'LastName': 'John Gallagher', 'Affiliation': ""Department of Respiratory Care, Rainbow Babies and Children's Hospital, Cleveland, Ohio.""}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Ross', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Speicher', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio.""}, {'ForeName': 'Alexandre T', 'Initials': 'AT', 'LastName': 'Rotta', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio.""}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Shein', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio.""}]",Pediatric pulmonology,['10.1002/ppul.25115']
2446,33049188,Impact of catheter size on pain and continence following robotic prostatectomy.,"INTRODUCTION Continence and catheter related pain following prostatectomy are significant patient concerns, and it is unknown whether catheter size impacts these variables. In this study, patients undergoing prostatectomy were randomized to receive either a 16 French or 20 French catheter to assess the impact of catheter size on postoperative continence and pain.
MATERIALS AND METHODS


Patients were prospectively randomized to receive either a 16 French or a 20 French latex catheter at the completion of prostatectomy. Subjects were asked on postoperative day 7 to report their average catheter-related pain and the amount of opioid medication used. International Prostate Symptom Score, Quality of Life score and pads per day were recorded 6 and 12 weeks postoperatively.
RESULTS


Fifty-two patients were randomized. Seven were excluded: surgeon catheter preference (3) or withdrawal of consent (4). Demographic and pathologic data did not differ between groups (all p > 0.20). Catheter pain scores and postoperative opioid use were not different between groups (all p > 0.78). Postoperative subjective urinary symptom scores, and pads per day did not differ between groups at both 6 and 12 weeks (all p > 0.16).
CONCLUSIONS


Catheter size did not impact postoperative urethral and bladder pain or continence prostatectomy. These data suggest that surgeon preference should guide catheter selection between 16-20 French. Future studies might investigate precise intraoperative anastomosis size measurement and the impact of catheter size on pain scores in a nonoperative population.",2020,"Postoperative subjective urinary symptom scores, and pads per day did not differ between groups at both 6 and 12 weeks (all p > 0.16).
","['Patients', 'Seven were excluded: surgeon catheter preference (3) or withdrawal of consent (4', 'Fifty-two patients were randomized', 'patients undergoing prostatectomy']","['robotic prostatectomy', '20 French latex catheter at the completion of prostatectomy', 'catheter size', '16 French or 20 French catheter']","['pain and continence', 'Postoperative subjective urinary symptom scores, and pads per day', 'Catheter pain scores and postoperative opioid use', 'Demographic and pathologic data', 'postoperative urethral and bladder pain or continence prostatectomy', 'pain scores', 'International Prostate Symptom Score, Quality of Life score and pads per day']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0023115', 'cui_str': 'Latex'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449963', 'cui_str': 'Size of catheter'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0232849', 'cui_str': 'Bladder pain'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",52.0,0.0632527,"Postoperative subjective urinary symptom scores, and pads per day did not differ between groups at both 6 and 12 weeks (all p > 0.16).
","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Stamm', 'Affiliation': 'Virginia Mason Medical Center, Seattle, Washington, USA.'}, {'ForeName': 'Basil', 'Initials': 'B', 'LastName': 'Ferenczi', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Porter', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kozlowski', 'Affiliation': ''}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Donahue', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Corman', 'Affiliation': ''}]",The Canadian journal of urology,[]
2447,33049220,Does Ultrasound-Guided Transversus Abdominis Plane Block Reduce Donor Site Pain After Harvesting Anterior Iliac Crest Bone Grafts.,"PURPOSE


The most common side-effect of anterior iliac crest (AIC) bone grafting is postoperative pain. The purpose of this study was to investigate the effectiveness of ultrasound-guided transversus abdominis plane (TAP) block for reducing donor site pain after harvesting AIC bone graft.
METHODS


Patients scheduled for unilateral alveolar cleft repair with AIC bone grafting, regardless of age, were enrolled in this prospective, randomized controlled trial study, dividing into two groups: group T (performing TAP block) and group C (without TAP block). Postoperative pain at the alveolar cleft and AIC site were assessed using a visual analog scale (VAS) at the immediate postoperative time, 6 hours, 12 hours, 24 hours after surgery. Morphine consumption during operation, postoperatively in the first 24 hours and total dosage until discharge and its side effects were also observed. Patients' satisfaction was accessed. MANOVA was used to evaluate the effects of treatment on those outcome variables. The P value <.05 was considered statistically significant.
RESULTS


Eighteen patients, with a mean age of 14.39 ± 3.70 years, were enrolled in this study. Pain scores at the AIC site in group T were statistically less significant than in group C for all times with P value <.001, <0.001, 0.002, and 0.004 consequently. Pain scores at the AIC site at 24 hours had nostatistically significant difference after Bonferroni correction. There was statistically significant greater patients' satisfaction in pain control at the AIC site in group T than in group C with P value <.001. Group T revealed, statistically significant, less morphine consumption than group C at both the first 24 hours and postoperatively, totally until discharge with P value <.001. No complications of TAP block were reported in this study. There was a statistically significant lower incidence of nausea in group T than in group C with P value 0.029.
CONCLUSIONS


The Ultrasound-Guided TAP block is an effective postoperative pain controller and can decrease postoperative morphine consumption at AIC bone harvesting.",2020,"Pain scores at the AIC site in group T were statistically less significant than in group C for all times with P value <.001, <0.001, 0.002, and 0.004 consequently.","['Eighteen patients, with a mean age of 14.39\xa0±\xa03.70 years', 'Patients scheduled for unilateral alveolar cleft repair with AIC bone grafting, regardless of age']","['ultrasound-guided transversus abdominis plane (TAP) block', 'group T (performing TAP block) and group C (without TAP block', 'Morphine', 'Harvesting Anterior Iliac Crest Bone Grafts', 'anterior iliac crest (AIC) bone grafting', 'Ultrasound-Guided TAP block', 'Ultrasound-Guided Transversus Abdominis Plane Block Reduce Donor Site Pain']","[""patients' satisfaction in pain control"", 'complications of TAP block', 'visual analog scale (VAS', 'Pain scores', 'nausea', 'morphine consumption', 'Postoperative pain', 'postoperative morphine consumption']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0432084', 'cui_str': 'Cleft of primary palate'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0223651', 'cui_str': 'Iliac crest structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0223651', 'cui_str': 'Iliac crest structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",,0.0688136,"Pain scores at the AIC site in group T were statistically less significant than in group C for all times with P value <.001, <0.001, 0.002, and 0.004 consequently.","[{'ForeName': 'Jakkrit', 'Initials': 'J', 'LastName': 'Sowapark', 'Affiliation': 'Resident, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Thunshuda', 'Initials': 'T', 'LastName': 'Sumphaongern', 'Affiliation': 'Instructor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand. Electronic address: thunshuda.s@hotmail.com.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.09.017']
2448,33049392,"As-needed Versus Regular Use of Fluticasone Furoate Nasal Spray in Patients With Moderate to Severe, Persistent, Perennial Allergic Rhinitis: A Randomized Controlled Trial.","BACKGROUND


Using intranasal corticosteroid (INCS) regularly is recommended for treating perennial allergic rhinitis (PAR). However, no studies have evaluated ""as-needed"" use.
OBJECTIVE


To compare the efficacy between as-needed and regular use of INCS in moderate-to-severe PAR patients.
METHODS


In a 6-week randomized controlled trial, participants were assigned to either fluticasone furoate (FF) nasal spray (27.5 μg) 2 sprays once daily for 1 week, followed by as-needed use (FF-as-needed) for 5 more weeks or 2 sprays once daily for 6 weeks (FF-regular). The primary outcome was a change in the total nasal symptom score (TNSS). The secondary outcomes were the change in nasal peak inspiratory flow (NPIF), Rhinoconjunctivitis Quality of Life-36 Questionnaire Score (RCQ-36), and cumulative FF dose.
RESULTS


One hundred and three patients, 51 in FF-as-needed and 52 in FF-regular, completed the study. The difference in mean change of TNSS between the two groups was not significant at week 6 (1.21 points; 95% CI, -0.08 to 2.49; P = 0.066). The FF-regular group tended towards a greater improvement in TNSS. The FF-regular group had higher mean change of NPIF than the FF-as-needed group at week 6 (-19.21 L/min; 95%CI, -33.54, -4.89; P=0.009). Both groups had similar improvement in RCQ-36. The mean cumulative FF dose in the FF-as-needed group was 51 % that of the FF-regular group.
CONCLUSION


Both as-needed and regular use of INCS had similar improvement in TNSS and RCQ-36 in PAR patients. As-needed use had half of INCS exposure of the regular use.",2020,Both as-needed and regular use of INCS had similar improvement in TNSS and RCQ-36 in PAR patients.,"['Patients With Moderate to Severe, Persistent, Perennial Allergic Rhinitis', 'moderate-to-severe PAR patients', 'perennial allergic rhinitis (PAR', 'One hundred and three patients, 51 in FF-as-needed and 52 in FF-regular, completed the study']","['intranasal corticosteroid (INCS', 'INCS', 'fluticasone furoate (FF) nasal spray', 'Fluticasone Furoate Nasal Spray']","['mean change of NPIF', 'RCQ-36', 'change in nasal peak inspiratory flow (NPIF), Rhinoconjunctivitis Quality of Life-36 Questionnaire Score (RCQ-36), and cumulative FF dose', 'TNSS and RCQ-36', 'mean change of TNSS', 'TNSS', 'mean cumulative FF dose', 'total nasal symptom score (TNSS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0035457', 'cui_str': 'Perennial allergic rhinitis'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0429205', 'cui_str': 'Nasal peak inspiratory flow'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}]",103.0,0.192399,Both as-needed and regular use of INCS had similar improvement in TNSS and RCQ-36 in PAR patients.,"[{'ForeName': 'Torpong', 'Initials': 'T', 'LastName': 'Thongngarm', 'Affiliation': 'Division of Allergy and Clinical Immunology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chamard', 'Initials': 'C', 'LastName': 'Wongsa', 'Affiliation': 'Division of Allergy and Clinical Immunology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Phichayut', 'Initials': 'P', 'LastName': 'Phinyo', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; Center for Clinical Epidemiology and Clinical Statistics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Paraya', 'Initials': 'P', 'LastName': 'Assanasen', 'Affiliation': 'Division of Rhinology and Allergy, Department of Otorhinolaryngology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pongsakorn', 'Initials': 'P', 'LastName': 'Tantilipikorn', 'Affiliation': 'Division of Rhinology and Allergy, Department of Otorhinolaryngology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Mongkhon', 'Initials': 'M', 'LastName': 'Sompornrattanaphan', 'Affiliation': 'Division of Allergy and Clinical Immunology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand. Electronic address: mongkhon.som@mahidol.ac.th.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.09.057']
2449,33049696,Smart glasses display device for fluoroscopically guided minimally invasive spinal instrumentation surgery: a preliminary study.,"OBJECTIVE


Most surgeons are forced to turn their heads away from the surgical field to see various intraoperative support monitors. These movements may result in inconvenience to surgeons and lead to technical difficulties and potential errors. Wearable devices that can be attached to smart glasses or any glasses are novel visualization tools providing an alternative screen in front of the user's eyes, allowing surgeons to keep their attention focused on the operative task without taking their eyes off the surgical field. The aim of the present study was to examine the feasibility of using glasses equipped with a wearable display device that transmits display monitor data during fluoroscopically guided minimally invasive spinal instrumentation surgery.
METHODS


In this pilot prospective randomized study, 20 consecutively enrolled patients who underwent single-segment posterior lumbar interbody fusion (PLIF) at L5-S1 performed using the percutaneous pedicle screw technique were randomly divided into two groups, a group for which the surgeon used a wearable display device attached to regular glasses while performing surgery (smart glasses group) and a group for which the surgeon did not use such a device (nonglasses group). Real-time intraoperative fluoroscopic images were wirelessly transmitted to the display device attached to the surgeon's glasses. The number of head turns performed by the surgeon to view the standard fluoroscopic monitor during procedures and the operative time, estimated blood loss, radiation exposure time, screw placement accuracy, and intraoperative complication rate were evaluated for comparison between the two groups.
RESULTS


The number of surgeon head turns to view the fluoroscopic monitor in the smart glasses group was 0.10 ± 0.31 times, which was significantly fewer than the head turns in the nonglasses group (82.4 ± 32.5 times; p < 0.001). The operative and radiation exposure times in the smart glasses group were shorter than those in the nonglasses group (operative time 100.2 ± 10.4 vs 105.5 ± 14.6 minutes, radiation exposure time 38.6 ± 6.6 vs 41.8 ± 16.1 seconds, respectively), although the differences were not significant. Postoperative CT showed one screw perforation in the nonglasses group, and no intraoperative complications were observed in either group.
CONCLUSIONS


This is, to the authors' knowledge, the first report on the feasibility of using this wearable display device attached to glasses for fluoroscopically guided minimally invasive spinal instrumentation surgery. Smart glasses display devices such as this one may be a valid option to facilitate better concentration on operative tasks by improving ergonomic efficiency during surgery.",2020,"The operative and radiation exposure times in the smart glasses group were shorter than those in the nonglasses group (operative time 100.2 ± 10.4 vs 105.5 ± 14.6 minutes, radiation exposure time 38.6 ± 6.6 vs 41.8 ± 16.1 seconds, respectively), although the differences were not significant.","['20 consecutively enrolled patients who underwent single-segment posterior lumbar interbody fusion (PLIF) at L5-S1 performed using the percutaneous pedicle screw technique', 'fluoroscopically guided minimally invasive spinal instrumentation surgery']",['wearable display device attached to regular glasses while performing surgery (smart glasses group) and a group for which the surgeon did not use such a device (nonglasses group'],"['intraoperative complications', 'operative and radiation exposure times', 'number of surgeon head turns to view the fluoroscopic monitor', 'operative time, estimated blood loss, radiation exposure time, screw placement accuracy, and intraoperative complication rate', 'screw perforation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0356967', 'cui_str': 'Spinal instrumentation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C5197727', 'cui_str': 'Smartglasses'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0560902', 'cui_str': 'Does turn head'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}]",20.0,0.0337934,"The operative and radiation exposure times in the smart glasses group were shorter than those in the nonglasses group (operative time 100.2 ± 10.4 vs 105.5 ± 14.6 minutes, radiation exposure time 38.6 ± 6.6 vs 41.8 ± 16.1 seconds, respectively), although the differences were not significant.","[{'ForeName': 'Keitaro', 'Initials': 'K', 'LastName': 'Matsukawa', 'Affiliation': ''}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Yato', 'Affiliation': ''}]",Journal of neurosurgery. Spine,['10.3171/2020.6.SPINE20644']
2450,33049701,Eight-Week Inspiratory Muscle Training Alters Electromyography Activity of the Ankle Muscles During Overhead and Single-Leg Squats: A Randomized Controlled Trial.,"This study was conducted to evaluate the effects of 8-week inspiratory muscle training on activity in the ankle muscles of athletes with chronic low-back pain. A randomized controlled trial involving 45 men and women with chronic low-back pain was carried out. Electromyography activity in the tibialis anterior, peroneus longus, gastrocnemius medialis, and gastrocnemius lateralis muscles of the dominant leg was recorded. Secondary outcomes included biopsychosocial indices, such as pain, disability, anxiety and depression, fear-avoidance beliefs, and fear of (re)injury. Static and dynamic overhead squat tests showed that inspiratory muscle training decreased activity in the tibialis anterior, peroneus longus, and gastrocnemius medialis muscles. In the static single-leg squat test and the descending phase of the dynamic equivalent, such a decrease was observed in all the 4 muscles. Inspiratory muscle training significantly reduced pain severity and activity in the tibialis anterior, peroneus longus, and gastrocnemius medialis muscles during the ascending phase of the dynamic single-leg squat test. On the basis of the findings, 8 weeks of inspiratory muscle training may constitute useful rehabilitation for reducing excessive activity in ankle joint muscles and aiding chronic low-back pain recovery.",2020,"Static and dynamic overhead squat tests showed that inspiratory muscle training decreased activity in the tibialis anterior, peroneus longus, and gastrocnemius medialis muscles.","['athletes with chronic low-back pain', '45 men and women with chronic low-back pain']","['Static and dynamic overhead squat tests', 'Eight-Week Inspiratory Muscle Training', 'inspiratory muscle training', '8-week inspiratory muscle training', 'Inspiratory muscle training']","['biopsychosocial indices, such as pain, disability, anxiety and depression, fear-avoidance beliefs, and fear of (re)injury', 'pain severity and activity in the tibialis anterior, peroneus longus, and gastrocnemius medialis muscles', 'Electromyography activity in the tibialis anterior, peroneus longus, gastrocnemius medialis, and gastrocnemius lateralis muscles of the dominant leg']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C2874943', 'cui_str': 'Fear of injury'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0224469', 'cui_str': 'Peroneus longus muscle structure'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",45.0,0.0241132,"Static and dynamic overhead squat tests showed that inspiratory muscle training decreased activity in the tibialis anterior, peroneus longus, and gastrocnemius medialis muscles.","[{'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Gholami-Borujeni', 'Affiliation': 'Bu-Ali Sina University.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Yalfani', 'Affiliation': 'Bu-Ali Sina University.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ahmadnezhad', 'Affiliation': 'Bu-Ali Sina University.'}]",Journal of applied biomechanics,['10.1123/jab.2019-0315']
2451,33049706,The Effectiveness of Isometric Contractions Compared With Isotonic Contractions in Reducing Pain For In-Season Athletes With Patellar Tendinopathy.,"Clinical Scenario: Patellar tendinopathy is a common musculoskeletal disorder affecting the lower-extremities and a difficult condition to manage for athletes that are in season. To facilitate improvement in function and to decrease pain, initial treatment for patellar tendinopathy is typically conservative. Traditional interventions may include eccentric training, cryotherapy, patellar counterforce straps, oral anti-inflammatories, injectable agents, phonophoresis, iontophoresis, orthotics, therapeutic ultrasound, and extracorporeal shockwave. In addition, recent literature suggests that implementing isometric and isotonic contractions may be effective in reducing patellar tendon pain. Focused Clinical Question: How effective are isometric contractions compared with isotonic contractions in reducing pain for in-season athletes with patellar tendinopathy? Summary of Key Findings: Implementation of isometric and isotonic exercises statistically reduced pain levels in the short term of 4 weeks for in-season athletes; however, isometric contractions provided statistically greater pain relief immediately for up to 45 minutes postintervention compared with isotonic contractions. Clinical Bottom Line: Current evidence supports the use of isometric and isotonic contractions to reduce pain for in-season athletes with patellar tendinopathy. Based on the reviewed literature, clinicians should consider utilizing heavy loaded isometrics or progressive heavy loaded isotonic exercises, which showed reduction in pain levels immediately after intervention and at 4-week follow-up for both intervention groups. Isometric contractions appear to provide greater pain relief immediately after intervention. Strength of Recommendation: There is Grade B evidence from 2 level 2 randomized controlled trials and 1 level 3 randomized crossover study supporting the use of isometric and isotonic contractions to reduce patellar tendon pain for in-season athletes.",2020,Current evidence supports the use of isometric and isotonic contractions to reduce pain for in-season athletes with patellar tendinopathy.,"['season athletes', 'Clinical Bottom Line', 'season athletes with patellar tendinopathy']","['Isometric Contractions', 'Isotonic Contractions', 'isometric and isotonic exercises', 'isotonic contractions', 'eccentric training, cryotherapy, patellar counterforce straps, oral anti-inflammatories, injectable agents, phonophoresis, iontophoresis, orthotics, therapeutic ultrasound, and extracorporeal shockwave', 'isometric and isotonic contractions']","['pain levels', 'pain relief', 'Pain', 'patellar tendon pain', 'Strength of Recommendation', 'pain']","[{'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}]","[{'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0022259', 'cui_str': 'Muscle isotonic contraction'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0183631', 'cui_str': 'Strap'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0031582', 'cui_str': 'Phonophoresis therapy'}, {'cui': 'C0022024', 'cui_str': 'Iontophoresis procedure'}, {'cui': 'C0029365', 'cui_str': 'Orthotic device'}, {'cui': 'C0041620', 'cui_str': 'Therapeutic ultrasound'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}]",,0.0249821,Current evidence supports the use of isometric and isotonic contractions to reduce pain for in-season athletes with patellar tendinopathy.,"[{'ForeName': 'Chee', 'Initials': 'C', 'LastName': 'Vang', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Niznik', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2019-0376']
2452,33049708,The Examination of Repeated Self-Mobilizations With Movement and Joint Mobilizations on Individuals With Chronic Ankle Instability.,"CONTEXT


Chronic ankle instability (CAI) is one of the most common chronic conditions in the world, resulting in millions of dollars contributed to the health care system. Joint mobilizations have been shown to effectively improve patient and disease-specific impairments secondary to CAI. The ability for patients to complete an effective manual therapy intervention without the need for continuous visits to a health care provider can alleviate burdens on the health care system and improve patient satisfaction.
OBJECTIVE


To examine the effect of clinician-applied Maitland talocrural joint mobilization and self-mobilization (Self-Mob) on dorsiflexion range of motion (DFROM), dynamic balance, strength, and perceived function in those with CAI.
DESIGN


Single-blind randomized trial.
SETTING


Research laboratory.
PARTICIPANTS


A total of 18 participants (7 males and 11 females; age = 20.78 [2.02] y, height = 67.66 [3.83] cm, limb length = 87.74 [5.05] cm) with self-reported CAI participated.
INTERVENTIONS


The participants received 6 interventions over a 2-week period. The participants received either Maitland grade III anterior-to-posterior talocrural joint mobilizations or weight-bearing lunge Self-Mob. Each intervention consisted of four 2-minute sets, with a 1-minute rest between sets.
MAIN OUTCOME MEASURES


The DFROM (weight-bearing lunge), dynamic balance (Y-Balance Test), isometric strength, Foot and Ankle Ability Measure Quick, Disablement of the Physically Active modified, Fear Avoidance Beliefs Questionnaire, and Tampa Scale of Kinesiophobia-11 were measured preintervention and postintervention.
RESULTS


Dynamic balance, isometric strength, and perceived function significantly improved in both groups at postintervention. The DFROM significantly improved in the Self-Mob group. Higher individual responder rates were demonstrated within the Self-Mob group compared with clinician-applied mobilizations.
CONCLUSIONS


Clinician-applied mobilizations and Self-Mobs are effective interventions for improving dynamic balance, isometric strength, and perceived function. Application of Self-Mobs can effectively improve DFROM compared with joint mobilization. Self-Mobs may be an effective intervention to incorporate into a home care plan.",2020,"Higher individual responder rates were demonstrated within the Self-Mob group compared with clinician-applied mobilizations.
","['Individuals With Chronic Ankle Instability', 'A total of 18 participants (7 males and 11 females; age = 20.78']","['clinician-applied Maitland talocrural joint mobilization and self-mobilization (Self-Mob', 'Self-Mobilizations With Movement and Joint Mobilizations', 'Maitland grade III anterior-to-posterior talocrural joint mobilizations or weight-bearing lunge Self-Mob']","['dorsiflexion range of motion (DFROM), dynamic balance, strength, and perceived function', 'DFROM', 'Dynamic balance, isometric strength, and perceived function', 'DFROM (weight-bearing lunge), dynamic balance (Y-Balance Test), isometric strength, Foot and Ankle Ability Measure Quick, Disablement of the Physically Active', 'dynamic balance, isometric strength, and perceived function', 'Higher individual responder rates', 'modified, Fear Avoidance Beliefs Questionnaire, and Tampa Scale of Kinesiophobia-11']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0231588', 'cui_str': 'Physiatric mobilization of joint'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}]",18.0,0.0197968,"Higher individual responder rates were demonstrated within the Self-Mob group compared with clinician-applied mobilizations.
","[{'ForeName': 'Connor A', 'Initials': 'CA', 'LastName': 'Burton', 'Affiliation': ''}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Arthur', 'Affiliation': ''}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Rivera', 'Affiliation': ''}, {'ForeName': 'Cameron J', 'Initials': 'CJ', 'LastName': 'Powden', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2019-0363']
2453,33049709,Effects of estradiol on biological age measured using the glycan age index.,"Glycan age is a recently developed biomarker based on glycans attached to immunoglobulin G (IgG). In large population cohorts, glycan age associates well with lifestyle and disease-risk biomarkers, while some studies suggested that glycan changes precede development of several age-associated diseases. In this study we evaluated effects of estrogen on the glycan age. Gonadal hormones were suppressed in 36 healthy young women by gonadotropin releasing hormone agonist therapy for 6 months. In 15 of them estradiol was supplemented, while 21 received placebo resulting in very low estrogen levels during intervention. IgG was isolated from plasma samples before intervention, after 6 months of intervention and after subsequent 4-month recovery. Deprivation of gonadal hormones resulted in median increase of glycan age for 9.1 years (IQR 6.8 - 11.5 years, p = 3.73×10 -8 ), which was completely prevented by transdermal estradiol therapy (change in glycan age = -0.23 years, IQR (-2.20 - 2.98). After the recovery period glycan age returned to baseline values in both groups. These results suggest that IgG glycans and consequently also the glycan age are under strong influence of gonadal hormones and that estradiol therapy can prevent the increase of glycan age that occurs in the perimenopausal period.",2020,After the recovery period glycan age returned to baseline values in both groups.,['36 healthy young women by'],"['gonadotropin releasing hormone agonist therapy', 'estradiol', 'placebo']",[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],36.0,0.0226459,After the recovery period glycan age returned to baseline values in both groups.,"[{'ForeName': 'Julija', 'Initials': 'J', 'LastName': 'Jurić', 'Affiliation': 'Genos Glycoscience Research Laboratory, Zagreb, Croatia.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Kohrt', 'Affiliation': 'Division of Geriatric Medicine, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Domagoj', 'Initials': 'D', 'LastName': 'Kifer', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Faculty of Pharmacy and Biochemistry, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Gavin', 'Affiliation': 'Division of Geriatric Medicine, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Pezer', 'Affiliation': 'Genos Glycoscience Research Laboratory, Zagreb, Croatia.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Nigrovic', 'Affiliation': 'Division of Rheumatology, Inflammation, and Immunity, Brigham and Women&#xB4;s Hospital, Boston, MA 02115, USA.'}, {'ForeName': 'Gordan', 'Initials': 'G', 'LastName': 'Lauc', 'Affiliation': 'Genos Glycoscience Research Laboratory, Zagreb, Croatia.'}]",Aging,['10.18632/aging.104060']
2454,33049730,A randomized controlled trial studying the effect of maternal hyperoxygenation on fetal heart rate in suspected fetal distress.,"Objective To investigate the effect of maternal hyperoxygenation on fetal heart rate (FHR) when applied for suspected fetal distress during the second stage of term labor. Approach A single-center randomized controlled trial was conducted in a tertiary care hospital in The Netherlands. Participants were included during the second stage of labor in case of an intermediary or abnormal FHR pattern. Patients were randomized to receive either 100% oxygen at 10L/min until delivery, or conventional care without additional oxygen. The primary outcome was the change in FHR pattern before and after the onset of the study, measured as the change in depth and duration of FHR decelerations. Secondary outcome measures were features based on phase-rectified signal averaging (PRSA), baseline assignability, and deceleration characteristics of the FHR pattern. Main results Between March 2016 and April 2018, 117 women were included. The FHR pattern could be analyzed for 71 participants, the other 46 women delivered before the end of the post time-frame. A 2.3% reduction in depth and duration of FHR decelerations was found after maternal hyperoxygenation, compared to a 10% increase in the control group (p=0.24). Maternal hyperoxygenation had a significantly positive effect on PRSA metrics, with a decrease in PRSA-acceleration capacity (p=0.03) and PRSA-deceleration capacity (p=0.02) in the intervention group compared to the control group. Significance The difference in depth and duration of decelerations after the start of the study was not significantly different between both study groups. A statistically significant positive effect on PRSA-deceleration capacity and PRSA-acceleration capacity was found after maternal hyperoxygenation, which might be associated with a positive effect on neonatal outcome. Trial registration The study was registered in the EudraCT-database (2015-001654-15) on April 3rd, 2015 and the Dutch Trial Register (NTR5461) on October 20th, 2015. URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-001654-15 and http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5461. Date of initial participant enrollment: March 2nd, 2016.",2020,"Maternal hyperoxygenation had a significantly positive effect on PRSA metrics, with a decrease in PRSA-acceleration capacity (p=0.03) and PRSA-deceleration capacity (p=0.02) in the intervention group compared to the control group.","['tertiary care hospital in The Netherlands', 'suspected fetal distress', 'EudraCT-database (2015-001654-15) on April 3rd, 2015 and the Dutch Trial Register (NTR5461) on October 20th, 2015', 'Main results Between March 2016 and April 2018, 117 women were included', 'Participants were included during the second stage of labor in case of an intermediary or abnormal FHR pattern', 'suspected fetal distress during the second stage of term labor']","['URL', '100% oxygen at 10L/min until delivery, or conventional care without additional oxygen', 'maternal hyperoxygenation']","['depth and duration of decelerations', 'fetal heart rate (FHR', 'change in depth and duration of FHR decelerations', 'features based on phase-rectified signal averaging (PRSA), baseline assignability, and deceleration characteristics of the FHR pattern', 'depth and duration of FHR decelerations', 'PRSA-deceleration capacity', 'PRSA-deceleration capacity and PRSA-acceleration capacity', 'change in FHR pattern', 'PRSA-acceleration capacity', 'fetal heart rate', 'PRSA metrics']","[{'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0015930', 'cui_str': 'Nonreassuring fetal status'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022872', 'cui_str': 'Second stage of labor'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0730018', 'cui_str': 'Abnormal fetal heart rate'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0022864', 'cui_str': 'Labor'}]","[{'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0457249', 'cui_str': 'Duration of deceleration (fetal heart rate)'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0429480', 'cui_str': 'Fetal heart deceleration'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",117.0,0.173753,"Maternal hyperoxygenation had a significantly positive effect on PRSA metrics, with a decrease in PRSA-acceleration capacity (p=0.03) and PRSA-deceleration capacity (p=0.02) in the intervention group compared to the control group.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Moors', 'Affiliation': 'Obstetrics and Gynecology, Maxima Medical Centre, Veldhoven, NETHERLANDS.'}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Joshi', 'Affiliation': 'Family Care Solutions, Philips Research, Eindhoven, 5656 AE, NETHERLANDS.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Bullens', 'Affiliation': 'Obstetrics and Gynecology, Rijnstate, Arnhem, Gelderland, NETHERLANDS.'}, {'ForeName': 'Noortje H M', 'Initials': 'NHM', 'LastName': 'van Oostrum', 'Affiliation': 'Obstetrics and Gynecology, Maxima Medical Centre, Veldhoven, Noord-Brabant, NETHERLANDS.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Regis', 'Affiliation': 'University of Technology Eindhoven Department of Mathematics and Computer Science, Eindhoven, Noord-Brabant, NETHERLANDS.'}, {'ForeName': 'Edwin R', 'Initials': 'ER', 'LastName': 'van den Heuvel', 'Affiliation': 'University of Technology Eindhoven Department of Mathematics and Computer Science, Eindhoven, Noord-Brabant, NETHERLANDS.'}, {'ForeName': 'S Guid', 'Initials': 'SG', 'LastName': 'Oei', 'Affiliation': 'Obstetrics and Gynecology, Maxima Medical Centre, Veldhoven, Noord-Brabant, NETHERLANDS.'}, {'ForeName': 'Judith O E H', 'Initials': 'JOEH', 'LastName': 'van Laar', 'Affiliation': 'Obstetrics and Gynecology, Maxima Medical Centre, Veldhoven, Noord-Brabant, NETHERLANDS.'}, {'ForeName': 'M Beatrijs', 'Initials': 'MB', 'LastName': 'van der Hout-van der Jagt', 'Affiliation': 'Obstetrics and Gynecology, Maxima Medical Centre, Veldhoven, Noord-Brabant, NETHERLANDS.'}]",Physiological measurement,['10.1088/1361-6579/abc0b6']
2455,33049804,Evaluation of the Effect of SPN-812 (Viloxazine Extended-Release) on QTc Interval in Healthy Adults.,"OBJECTIVE


To assess the effects of a supratherapeutic dose of SPN-812, a drug currently under investigation as a treatment for attention-deficit/hyperactivity disorder, on cardiac repolarization (QTc) in healthy adults.
METHODS


The study was conducted from June 27, 2018, to July 10, 2018. It had a double-blind, randomized, crossover design in which subjects received a 3-treatment sequence-placebo, 400 mg moxifloxacin, and 1,800 mg SPN-812 for 2 consecutive days (separated by at least a 3-day washout). The primary endpoint was the correlation between the change from baseline (CFB) in individual heart rate corrected QT interval (QTcI) (ΔQTcI) and viloxazine and 5-hydroxyviloxazine glucuronide (5-OH-VLX-gluc) plasma concentrations (Cps). The secondary endpoint was the time point placebo-adjusted CFB in QTcI (ΔΔQTcI) for viloxazine. For assay sensitivity, the correlations between moxifloxacin Cp and the ΔQTcI, and moxifloxacin and time point ΔΔQTcI were evaluated. Additional evaluations included Fridericia's formula QT correction, heart rate, and the PR and QRS intervals. Changes in electrocardiogram (ECG) morphology along with other safety parameters were also analyzed and reported.
RESULTS


The correlation between ΔQTcI and viloxazine Cp demonstrated a statistically significant negative slope (P = .0012). 5-OH-VLX-gluc Cp and ΔQTcI also demonstrated a statistically significant negative slope (P = .0007). Secondary time point analyses showed no effect of SPN-812 on QTcI. Assay sensitivity with moxifloxacin was confirmed. Safety parameters were acceptable.
CONCLUSIONS


This study demonstrated that SPN-812 had no effect on cardiac repolarization or other ECG parameters in healthy adults, suggesting that it is not associated with a risk for cardiac arrhythmias or other electrocardiographic parameters.",2020,The correlation between ΔQTcI and viloxazine Cp demonstrated a statistically significant negative slope (P = .0012).,"['Healthy Adults', 'June 27, 2018, to July 10, 2018', 'healthy adults']","['moxifloxacin, and 1,800 mg SPN-812', 'moxifloxacin', 'SPN-812 (Viloxazine Extended-Release', '3-treatment sequence-placebo', 'SPN-812']","['Changes in electrocardiogram (ECG) morphology', 'QTcI. Assay sensitivity', 'cardiac repolarization', ""Fridericia's formula QT correction, heart rate, and the PR and QRS intervals"", 'change from baseline (CFB) in individual heart rate corrected QT interval (QTcI) (ΔQTcI) and viloxazine and 5-hydroxyviloxazine glucuronide (5-OH-VLX-gluc) plasma concentrations (Cps', 'time point placebo-adjusted CFB in QTcI (ΔΔQTcI']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C2350019', 'cui_str': 'Solitary nodule of lung'}, {'cui': 'C0042665', 'cui_str': 'Viloxazine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0855329', 'cui_str': 'Electrocardiogram change'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0520880', 'cui_str': 'QRS interval'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0042665', 'cui_str': 'Viloxazine'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0149958', 'cui_str': 'Partial Seizures, Complex'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}]",,0.135146,The correlation between ΔQTcI and viloxazine Cp demonstrated a statistically significant negative slope (P = .0012).,"[{'ForeName': 'Azmi', 'Initials': 'A', 'LastName': 'Nasser', 'Affiliation': 'Supernus Pharmaceuticals, Inc., 9715 Key West Ave, Rockville, MD 20850. anasser@supernus.com.'}, {'ForeName': 'Shamia L', 'Initials': 'SL', 'LastName': 'Faison', 'Affiliation': 'Supernus Pharmaceuticals, Inc, Rockville, Maryland, USA.'}, {'ForeName': 'Tesfaye', 'Initials': 'T', 'LastName': 'Liranso', 'Affiliation': 'Supernus Pharmaceuticals, Inc, Rockville, Maryland, USA.'}, {'ForeName': 'Toyin', 'Initials': 'T', 'LastName': 'Adewole', 'Affiliation': 'Supernus Pharmaceuticals, Inc, Rockville, Maryland, USA.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Busse', 'Affiliation': 'Supernus Pharmaceuticals, Inc, Rockville, Maryland, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Kleiman', 'Affiliation': 'eResearch Technology, Inc, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schwabe', 'Affiliation': 'Supernus Pharmaceuticals, Inc, Rockville, Maryland, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.20m13395']
2456,33049909,Effect of Family-Based REDUCE Intervention Program on Children Eating Behavior and Dietary Intake: Randomized Controlled Field Trial.,"The objective of this study was to evaluate the effect of a family-based intervention program (REDUCE) on children's eating behaviors and dietary intake. A two-arm randomized controlled field trial was conducted among parents and children of 7 to 10 years old who were either overweight or obese. The intervention was conducted via face-to-face sessions and social media. The child eating behaviors were assessed using the child eating behaviors questionnaire (CEBQ), while their dietary consumption of vegetables and unhealthy snacks was assessed using a parental report of three days unweighted food. The generalized linear mixed modelling adjusted for covariates was used to estimate the intervention effects with alpha of 0.05. A total of 122 parents (91% response rate) completed this study. At the six-month post-training, there were statistically significant mean differences in the enjoyment of food (F(6481) = 4.653,  p  < 0.001), fruit and vegetable intake (F(6480) = 4.165,  p  < 0.001) and unhealthy snack intake (F(6480) = 5.062,  p  < 0.001) between the intervention and wait-list groups; however, it was not clinically meaningful. This study added to the body of knowledge of family-based intervention that utilized social media and assessed the effect in children's eating behavior using the CEBQ and children's dietary intake.",2020,"p  < 0.001) and unhealthy snack intake (F(6480) = 5.062,  p  < 0.001) between the intervention and wait-list groups; however, it was not clinically meaningful.","[""children's eating behaviors and dietary intake"", '122 parents (91% response rate) completed this study', ""children's eating behavior using the CEBQ and children's dietary intake"", 'parents and children of 7 to 10 years old who were either overweight or obese', 'Children Eating Behavior and Dietary Intake']","['Family-Based REDUCE Intervention Program', 'family-based intervention program (REDUCE']","['child eating behaviors questionnaire (CEBQ), while their dietary consumption of vegetables and unhealthy snacks', 'child eating behaviors', 'unhealthy snack intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",122.0,0.0364819,"p  < 0.001) and unhealthy snack intake (F(6480) = 5.062,  p  < 0.001) between the intervention and wait-list groups; however, it was not clinically meaningful.","[{'ForeName': 'Norliza', 'Initials': 'N', 'LastName': 'Ahmad', 'Affiliation': 'Department of Community Health, Faculty of Medicine and Health Science, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Zalilah Mohd', 'Initials': 'ZM', 'LastName': 'Shariff', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Science, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Firdaus', 'Initials': 'F', 'LastName': 'Mukhtar', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Health Science, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Munn-Sann', 'Initials': 'MS', 'LastName': 'Lye', 'Affiliation': 'Department of Community Health, Faculty of Medicine and Health Science, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}]",Nutrients,['10.3390/nu12103065']
2457,33049927,Effect of an Ergonomics Educational Program on Musculoskeletal Disorders in Nursing Staff Working in the Operating Room: A Quasi-Randomized Controlled Clinical Trial.,"Background:  Nursing staff working in the operating room are exposed to risk factors that can cause musculoskeletal disorders (MSDs) and work-related disabilities. The use of ergonomics principles can help with the prevention of MSDs. This study aimed to examine the effect of an ergonomics educational program on MSDs among nursing staff working in the operating room.  Methods:  In this pragmatic parallel group quasi-randomized controlled clinical trial, 74 nursing staff working in the operating rooms of two teaching hospitals participated. The hospitals were randomly assigned to either the intervention or the control group and all nursing staff working in the operating room of each hospital were invited to take part in this research. They were initially assessed for the prevalence and risk of MSDs by using the Nordic questionnaire and the rapid entire body assessment (REBA) checklist. The intervention group received the ergonomics educational program and were assessed in two-week intervals over a period of three months. At the end of the study, the risk and prevalence of MSDs were compared between the intervention and control groups.  Results:  Statistically significant differences were reported between the groups in terms of the prevalence and risk of MSDs. The overall risk of MSDs decreased in the intervention group after the educational program ( p  = 0.03). The reduction in the prevalence of MSDs in the different parts of the body in the intervention group was as follows: ankle ( p  = 0.005), hand/wrist ( p  = 0.041), low back ( p  = 0.000), the neck ( p  = 0.003), hip ( p  = 0.001) and shoulder ( p  = 0.043).  Conclusion:  The education of nursing staff about ergonomics can influence the prevalence and risk of MSDs. Therefore, it should be incorporated into the degree education and on-the-job training initiatives for nurses working in the operating theatre in order to reduce workplace injuries and associated absences, and increase the quality of care delivered by them. This clinical trial has been registered in the Iranian Registry of Clinical Trials: IRCT2015081823677N1.",2020,The overall risk of MSDs decreased in the intervention group after the educational program ( p  = 0.03).,"['74 nursing staff working in the operating rooms of two teaching hospitals participated', 'Musculoskeletal Disorders in Nursing Staff Working in the Operating Room']","['control group and all nursing staff working', 'Ergonomics Educational Program', 'ergonomics educational program']","['prevalence and risk of MSDs by using the Nordic questionnaire and the rapid entire body assessment (REBA) checklist', 'risk and prevalence of MSDs', 'prevalence and risk of MSDs', 'prevalence of MSDs', 'overall risk of MSDs']","[{'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0029064', 'cui_str': 'Operating theatre'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0268263', 'cui_str': 'Multiple sulfatase deficiency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",74.0,0.0344032,The overall risk of MSDs decreased in the intervention group after the educational program ( p  = 0.03).,"[{'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Abdollahi', 'Affiliation': 'School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran 1419733171, Iran.'}, {'ForeName': 'Shadan', 'Initials': 'S', 'LastName': 'Pedram Razi', 'Affiliation': 'School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran 1419733171, Iran.'}, {'ForeName': 'Daryoush', 'Initials': 'D', 'LastName': 'Pahlevan', 'Affiliation': 'Social Determinants of Health Research Centre, Semnan University of Medical Sciences, Semnan 3514799422, Iran.'}, {'ForeName': 'Mir Saeed', 'Initials': 'MS', 'LastName': 'Yekaninejad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran 1417613151, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Amaniyan', 'Affiliation': 'Student Research Center, Semnan University of Medical Sciences, Semnan 3514799422, Iran.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leibold Sieloff', 'Affiliation': 'College of Nursing, Montana State University, Bozeman, MT 172220, USA.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Vaismoradi', 'Affiliation': 'Faculty of Nursing and Health Sciences, Nord University, 8049 Bodø, Norway.'}]",International journal of environmental research and public health,['10.3390/ijerph17197333']
2458,33049973,Effect of Added Sugar on the Consumption of A Lipid-Based Nutrient Supplement Among 7-24-Month-Old Children.,"Small-quantity lipid-based nutrient supplements (SQ-LNS) could help prevent malnutrition. Our primary objective was to examine the acceptability and consumption of sweetened and unsweetened versions of SQ-LNS before and after 14-days of repeated exposure. A total of 78 mother-infant dyads recruited from health centers in Morelos, Mexico, were randomized to two groups of SQ-LNS (sweetened, LNS-S; unsweetened, LNS-U). During the study, infants were fed SQ-LNS (20 g) mixed with 30 g of complementary food of the caregiver's choice. The amount of supplement-food mixture consumed was measured before, during and after a 14-day home exposure period. We defined acceptability as consumption of at least 50% of the offered food mixture. At initial exposure, LNS-U consumption was on average 44.0% (95% CI: 31.4, 58.5) and LNS-S 34.8% (25.3, 44.0); at final exposure, LNS-U and LNS-S consumption were 38.5% (27.8, 54.0) and 31.5% (21.6, 43.0). The average change in consumption did not differ between the groups (2.2 p.p. (-17.2, 24.4)). We conclude that the acceptability of sweetened and unsweetened SQ-LNS was low in this study population. Since consumption did not differ between supplement versions, we encourage the use of the unsweetened version given the potential effects that added sugar may have on weight gain especially in regions facing the double burden of malnutrition.",2020,The average change in consumption did not differ between the groups (2.2 p.p.,"['78 mother-infant dyads recruited from health centers in Morelos, Mexico', '7-24-Month-Old Children']","['Small-quantity lipid-based nutrient supplements (SQ-LNS', 'Added Sugar', 'SQ-LNS']","['acceptability and consumption of sweetened and unsweetened versions of SQ-LNS', 'average change in consumption', 'LNS-U consumption']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023374', 'cui_str': 'Lesch-Nyhan syndrome'}]",,0.147884,The average change in consumption did not differ between the groups (2.2 p.p.,"[{'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Okronipa', 'Affiliation': 'Institute of Global Nutrition, Department of Nutrition, University of California, Davis, 3135 Meyer Hall, One Shields Avenue, Davis, CA 95616, USA.'}, {'ForeName': 'Amado D', 'Initials': 'AD', 'LastName': 'Quezada-Sánchez', 'Affiliation': 'Center for Evaluation and Surveys Research, National Institute of Public Health, Avenida Universidad, Santa María Ahuacatitlán, Cuernavaca 62100, Mexico.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Johnson', 'Affiliation': 'Department of Pediatrics, Section of Nutrition, School of Medicine, University of Colorado Anschutz Medical Campus, East 17th Place Mail Stop C225, Aurora, CO 80045, USA.'}, {'ForeName': 'Cloe', 'Initials': 'C', 'LastName': 'Rawlinson', 'Affiliation': 'Center for Research in Nutrition and Health, National Institute of Public Health, Avenida Universidad 655, Santa María Ahuacatitlán, Cuernavaca 62100, Mexico.'}, {'ForeName': 'Selene', 'Initials': 'S', 'LastName': 'Pacheco-Miranda', 'Affiliation': 'Center for Research in Nutrition and Health, National Institute of Public Health, Avenida Universidad 655, Santa María Ahuacatitlán, Cuernavaca 62100, Mexico.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Venosa López', 'Affiliation': 'Center for Research in Nutrition and Health, National Institute of Public Health, Avenida Universidad 655, Santa María Ahuacatitlán, Cuernavaca 62100, Mexico.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Gonzalez Navarrete', 'Affiliation': 'Global Alliance for Improved Nutrition, Rue de Vermont 37-39, 1202 Genève, Switzerland.'}, {'ForeName': 'Anabelle Bonvecchio', 'Initials': 'AB', 'LastName': 'Arenas', 'Affiliation': 'Center for Research in Nutrition and Health, National Institute of Public Health, Avenida Universidad 655, Santa María Ahuacatitlán, Cuernavaca 62100, Mexico.'}]",Nutrients,['10.3390/nu12103069']
2459,33050038,The Role of the Teacher in the Implementation of a School-Based Intervention on the Physical Activity Practice of Children.,"Medium- or long-term intervention strategies for physical activity practice (PAP) need to be more effective in terms of their implementation by practitioners. The aim of this study was to evaluate the role of a teacher to implement the Team Pentathlon (TP) in order to improve the PAP in primary children. TP is a health education program made to improve PAP of children through individual and collective achievements. In this study, 203 children (age: 10-13 years) in grades 5 and 6 (intervention group (IG)  N  = 104, control group (CG)  N  = 99) were guided to increase their PAP during an eight-week period by five elementary school teachers (physical education or classroom) who had received four training sessions. Levels of PAP (self-reported) were compared between groups (IG/CG), sex, socioeconomic status of the schools and between teachers: baseline and during TP. Several teachers noted significant increases in PAP in the IG for both boys and girls ( p  ≤ 0.05 or  p  < 0.01), whereas others found only small improvements in PAP. One teacher even observed higher PAP in the CG. Training session records revealed that the teacher himself, how the TP is implemented, and proper resources were the three elements that explained the successful implementation of the TP program. The implementation of the TP significantly increased the PAP in primary children. Training sessions helped teachers to implement the TP program but personal engagement, motivation, respecting protocol, and an adequate environment are also necessary in improving the PAP of children.",2020,"Several teachers noted significant increases in PAP in the IG for both boys and girls ( p  ≤ 0.05 or  p  < 0.01), whereas others found only small improvements in PAP.","['primary children', 'Children', '203 children (age: 10-13 years) in grades 5 and 6 (intervention group (IG)  N  = 104, control group (CG)  N  = 99) were']","['guided to increase their PAP during an eight-week period by five elementary school teachers (physical education or classroom) who had received four training sessions', 'Team Pentathlon (TP']","['Levels of PAP (self-reported', 'PAP']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0870482', 'cui_str': 'Elementary School Teachers'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205450', 'cui_str': '4'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",203.0,0.0103558,"Several teachers noted significant increases in PAP in the IG for both boys and girls ( p  ≤ 0.05 or  p  < 0.01), whereas others found only small improvements in PAP.","[{'ForeName': 'Tegwen', 'Initials': 'T', 'LastName': 'Gadais', 'Affiliation': 'Department of Physical Activity Sciences, University of Quebec in Montreal, Montreal, QC H3C 3P8, Canada.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Caron', 'Affiliation': ""Faculté des Sports et de l'EP, Université d'Artois, 62800 Liévin, France.""}, {'ForeName': 'Marie-Belle', 'Initials': 'MB', 'LastName': 'Ayoub', 'Affiliation': 'Department of Physical Activity Sciences, University of Quebec in Montreal, Montreal, QC H3C 3P8, Canada.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Karelis', 'Affiliation': 'Department of Physical Activity Sciences, University of Quebec in Montreal, Montreal, QC H3C 3P8, Canada.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Nadeau', 'Affiliation': 'Department of Physical Education, Laval University, Quebec City, QC G1V 0A6, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17197344']
2460,33050072,"Lipid Profile, Lipoprotein Subfractions, and Fluidity of Membranes in Children and Adolescents with Depressive Disorder: Effect of Omega-3 Fatty Acids in a Double-Blind Randomized Controlled Study.","Depressive disorder (DD) is a psychiatric disorder whose molecular basis is not fully understood. It is assumed that reduced consumption of fish and omega-3 fatty acids (FA) is associated with DD. Other lipids such as total cholesterol (TCH), LDL-, and HDL-cholesterols (LDL-CH, HDL-CH) also play a role in depression. The primary endpoint of the study was the effect of omega-3 FA on the severity of depression in children and adolescents. This study aimed to investigate the secondary endpoint, relationship between depressive disorder symptoms and lipid profile, LDL- and HDL-cholesterol subfractions, Paraoxonase 1 (PON1) activities, and erythrocyte membrane fluidity in 58 depressed children and adolescents (calculated by the statistical program on the effect size), as well as the effect of omega-3 FA on the monitored parameters. Depressive symptoms were assessed by the Children's Depression Inventory (CDI), lipid profile by standard biochemical procedures, and LDL- and HDL-subfractions by the Lipoprint system. Basic biochemical parameters including lipid profile were compared with levels in 20 healthy children and were in the physiological range. Improvement of symptoms in the group supplemented with a fish oil emulsion rich in omega-3 FA in contrast to omega-6 FA (emulsion of sunflower oil) has been observed. We are the first to report that omega-3 FAs, but not omega-6 FA, increase large HDL subfractions (anti-atherogenic) after 12 weeks of supplementation and decrease small HDL subfractions (proatherogenic) in depressed children. We found a negative correlation between CDI score and HDL-CH and the large HDL subfraction, but not LDL-CH subfractions. CDI score was not associated with erythrocyte membrane fluidity. Our results suggest that HDL-CH and its subfractions, but not LDL-CH may play a role in the pathophysiology of depressive disorder. The study was registered under ISRCTN81655012.",2020,The primary endpoint of the study was the effect of omega-3 FA on the severity of depression in children and adolescents.,"['58 depressed children and adolescents (calculated by the statistical program on the effect size', 'Children and Adolescents with Depressive Disorder', '20 healthy children', 'children and adolescents']","['Omega-3 Fatty Acids', 'omega-3 FA']","['severity of depression', 'CDI score', 'Lipid Profile, Lipoprotein Subfractions, and Fluidity of Membranes', 'depressive disorder symptoms and lipid profile, LDL- and HDL-cholesterol subfractions, Paraoxonase 1 (PON1) activities, and erythrocyte membrane fluidity', ""Children's Depression Inventory (CDI), lipid profile by standard biochemical procedures, and LDL- and HDL-subfractions"", 'small HDL subfractions (proatherogenic', 'Depressive symptoms', 'total cholesterol (TCH), LDL-, and HDL-cholesterols (LDL-CH, HDL-CH']","[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0686744', 'cui_str': 'Well child'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0282601', 'cui_str': 'Compact Disk Interactive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C1121571', 'cui_str': 'Paraoxonase 1'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0014780', 'cui_str': 'Erythrocyte Cytoskeleton'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",58.0,0.0365219,The primary endpoint of the study was the effect of omega-3 FA on the severity of depression in children and adolescents.,"[{'ForeName': 'Katrenčíková', 'Initials': 'K', 'LastName': 'Barbora', 'Affiliation': 'Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry, Faculty of Medicine, Comenius University, Sasinkova 2, 813 72 Bratislava, Slovakia.'}, {'ForeName': 'Vaváková', 'Initials': 'V', 'LastName': 'Magdaléna', 'Affiliation': 'Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry, Faculty of Medicine, Comenius University, Sasinkova 2, 813 72 Bratislava, Slovakia.'}, {'ForeName': 'Waczulíková', 'Initials': 'W', 'LastName': 'Iveta', 'Affiliation': 'Department of Nuclear Physics and Biophysics, Faculty of Mathematics, Physics and Informatics, Comenius University, Mlynská dolina F1, 842 48 Bratislava, Slovakia.'}, {'ForeName': 'Oravec', 'Initials': 'O', 'LastName': 'Stanislav', 'Affiliation': '1st Department of Internal Medicine, Faculty of Medicine, Comenius University, Mickiewiczova 13, 81369 Bratislava, Slovakia.'}, {'ForeName': 'Garaiova', 'Initials': 'G', 'LastName': 'Iveta', 'Affiliation': 'Research and Development. Cultech Ltd., Unit 2 Christchurch Road, Port Talbot SA12 7BZ, UK.'}, {'ForeName': 'Nagyová', 'Initials': 'N', 'LastName': 'Zuzana', 'Affiliation': 'Pediatric center, Juvenalia, s.r.o, Veľkoblahovská 44A, 929 01 Dunajská Streda, Slovakia.'}, {'ForeName': 'Hlaváčová', 'Initials': 'H', 'LastName': 'Nataša', 'Affiliation': 'Institute of Experimental Endocrinology, Biomedical Research Center of the Slovak Academy of Sciences, Dúbravská cesta 9, 945 05 Bratislava, Slovakia.'}, {'ForeName': 'Ďuračková', 'Initials': 'Ď', 'LastName': 'Zdenka', 'Affiliation': 'Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry, Faculty of Medicine, Comenius University, Sasinkova 2, 813 72 Bratislava, Slovakia.'}, {'ForeName': 'Trebatická', 'Initials': 'T', 'LastName': 'Jana', 'Affiliation': ""Department of Child and Adolescent Psychiatry, Faculty of Medicine and The National Institute of Children's Diseases, Comenius University, Limbová 1, 833 40 Bratislava, Slovakia.""}]",Biomolecules,['10.3390/biom10101427']
2461,33050115,Attention Networks in ADHD Adults after Working Memory Training with a Dual  n -Back Task.,"Patients affected by Attention-Deficit/Hyperactivity Disorder (ADHD) are characterized by impaired executive functioning and/or attention deficits. Our study aim is to determine whether the outcomes measured by the Attention Network Task (ANT), i.e., the reaction times (RTs) to specific target and cue conditions and alerting, orienting, and conflict (or executive control) effects are affected by cognitive training with a Dual  n -back task. We considered three groups of young adult participants: ADHD patients without medication (ADHD), ADHD with medication (MADHD), and age/education-matched controls. Working memory training consisted of a daily practice of 20 blocks of Dual  n -back task (approximately 30 min per day) for 20 days within one month. Participants of each group were randomly assigned into two subgroups, the first one with an adaptive mode of difficulty ( adaptive  training), while the second was blocked at the level 1 during the whole training phase (1-back task,  baseline  training). Alerting and orienting effects were not modified by working memory training. The dimensional analysis showed that after  baseline  training, the lesser the severity of the hyperactive-impulsive symptoms, the larger the improvement of reaction times on trials with high executive control/conflict demand (i.e., what is called  Conflict Effect ), irrespective of the participants' group. In the categorical analysis, we observed the improvement in such  Conflict Effect  after the  adaptive  training in adult ADHD patients irrespective of their medication, but not in controls. The ex-Gaussian analysis of RT and RT variability showed that the improvement in the  Conflict Effect  correlated with a decrease in the proportion of extreme slow responses. The Dual  n -back task in the  adaptive  mode offers as a promising candidate for a cognitive remediation of adult ADHD patients without pharmaceutical medication.",2020,Alerting and orienting effects were not modified by working memory training.,"['adult ADHD patients without pharmaceutical medication', 'young adult participants: ADHD patients without medication (ADHD), ADHD with medication (MADHD), and age/education-matched controls', 'ADHD Adults after Working Memory Training with a Dual  n -Back Task']","['cognitive training with a Dual  n -back task', 'adaptive mode of difficulty ( adaptive  training), while the second was blocked at the level 1 during the whole training phase (1-back task,  baseline  training']","['proportion of extreme slow responses', 'severity of the hyperactive-impulsive symptoms', 'reaction times (RTs) to specific target and cue conditions and alerting, orienting, and conflict (or executive control) effects']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0316141,Alerting and orienting effects were not modified by working memory training.,"[{'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Dotare', 'Affiliation': 'School of Medicine, Yamaguchi University, 1-1-1 Minami-kogushi, Ube, Yamaguchi 755-8505, Japan.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Bader', 'Affiliation': 'Department of Psychiatry -SUPEA, University Hospital of Lausanne, CH-1004 Lausanne, Switzerland.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Mesrobian', 'Affiliation': 'NeuroHeuristic Research Group, HEC-Lausanne, University of Lausanne, Quartier UNIL-Chamberonne, CH-1015 Lausanne, Switzerland.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Asai', 'Affiliation': 'Department of Systems Bioinformatics, Graduate School of Medicine, Yamaguchi University, 1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan.'}, {'ForeName': 'Alessandro E P', 'Initials': 'AEP', 'LastName': 'Villa', 'Affiliation': 'NeuroHeuristic Research Group, HEC-Lausanne, University of Lausanne, Quartier UNIL-Chamberonne, CH-1015 Lausanne, Switzerland.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Lintas', 'Affiliation': 'NeuroHeuristic Research Group, HEC-Lausanne, University of Lausanne, Quartier UNIL-Chamberonne, CH-1015 Lausanne, Switzerland.'}]",Brain sciences,['10.3390/brainsci10100715']
2462,33050123,Three-Dimensional Assessment of Mandibular Condylar Volume and Position Subsequent to Twin Block Functional Therapy of Skeletal Class II Malocclusion Accompanied by Low-Level Laser Therapy.,"This study aimed to evaluate and compare the effect of low-level laser therapy (LLLT) on mandibular condylar volume and position following treatment of a Class II malocclusion with a twin block (TB) appliance employing cone beam computed tomography (CBCT). Twenty-four growing patients, aged 9-12 years, were randomly allocated into control and laser groups. All patients were treated with a TB appliance. The patients in the laser group were treated weekly with a gallium-aluminum-arsenide (GaAlAs) diode laser around the temporomandibular joint (TMJ) region for three months. CBCT images were obtained before and after TB therapy and the changes in TMJ and skeletal variables were evaluated and compared among and between the groups. In the laser group, the condylar volume of the right and left sides significantly increased by 213.3 mm 3  and 231.2 mm 3 , respectively ( p  < 0.05), whereas in the control group it significantly increased by 225.2 mm 3 , and 244.2 mm 3 , respectively ( p  < 0.05), with forward and lateral positioning of both sides. Furthermore, effective mandibular, ramus, and corpus lengths were increased, which were not significant between the groups. Low-Level Laser therapy accomplished no considerable effect on mandibular condylar volume and position following the functional orthopedic treatment of skeletal Class II malocclusions using a TB appliance.",2020,Low-Level Laser therapy accomplished no considerable effect on mandibular condylar volume and position following the functional orthopedic treatment of skeletal Class II malocclusions using a TB appliance.,"['a Class II malocclusion with a twin', 'Twenty-four growing patients, aged 9-12 years', 'Skeletal Class II Malocclusion']","['Low-Level Laser therapy', 'gallium-aluminum-arsenide (GaAlAs) diode laser around the temporomandibular joint (TMJ', 'block (TB) appliance employing cone beam computed tomography (CBCT', 'low-level laser therapy (LLLT']","['condylar volume of the right and left sides', 'Furthermore, effective mandibular, ramus, and corpus lengths', 'TMJ and skeletal variables']","[{'cui': 'C0399524', 'cui_str': 'Malocclusion, Angle class II, division 1'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0016980', 'cui_str': 'Gallium'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0039493', 'cui_str': 'Temporomandibular joint structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0039493', 'cui_str': 'Temporomandibular joint structure'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",24.0,0.0244294,Low-Level Laser therapy accomplished no considerable effect on mandibular condylar volume and position following the functional orthopedic treatment of skeletal Class II malocclusions using a TB appliance.,"[{'ForeName': 'Mahmoud Abdel', 'Initials': 'MA', 'LastName': 'Hameed Mohamed', 'Affiliation': 'Department of Orthodontics, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo 11651, Egypt.'}, {'ForeName': 'Khaled Farouk', 'Initials': 'KF', 'LastName': 'Abdallah', 'Affiliation': 'Department of Orthodontics, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo 11651, Egypt.'}, {'ForeName': 'Farouk Ahmed', 'Initials': 'FA', 'LastName': 'Hussein', 'Affiliation': 'Department of Orthodontics, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo 11651, Egypt.'}]",Dentistry journal,['10.3390/dj8040115']
2463,33050169,Acute Effects of Metformin and Vildagliptin after a Lipid-Rich Meal on Postprandial Microvascular Reactivity in Patients with Type 2 Diabetes and Obesity: A Randomized Trial.,"BACKGROUND


Type 2 diabetes mellitus and obesity are both related to endothelial dysfunction. Postprandial lipemia is a cardiovascular risk. Notably, it is known that a high-fat diet may elicit microvascular dysfunction, even in healthy subjects. Since anti-diabetic drugs have different mechanisms of action and also distinct vascular benefits, we aimed to compare the results of two anti-diabetic drugs after the intake of a lipid-rich meal on microcirculation in patients with type 2 diabetes and obesity. In parallel, we also investigated the metabolic profile, oxidative stress, inflammation, plasma viscosity, and some gastrointestinal peptides.
SUBJECTS/METHODS


We included 38 drug-naïve patients, all women aged between 19 and 50 years, with BMI ≥ 30 kg/m 2 . We performed endothelial measurements and collected samples before (fasting) and after the intake of a lipid-rich meal at 30, 60, 120, and 180 min. Patients were randomized to metformin or vildagliptin, given orally just before the meal. Endothelial function was assessed by videocapillaroscopy and laser-Doppler flowmetry to investigate microvascular reactivity. Besides, we also investigated plasma viscosity, inflammatory and oxidative stress biomarkers, gastrointestinal peptides, and metabolic profile in all time points.
RESULTS


No differences at baseline were noted between groups. Vildagliptin increased glucagon-like peptide-1 compared to metformin. Paired comparisons showed that, during the postprandial period, vildagliptin significantly changed levels of insulin and glucagon-like peptide-1, and also the dipeptidyl peptidase-4 activity, while metformin had effects on plasma glucose solely. Metformin use during the test meal promoted an increase in functional capillary density, while vildagliptin kept non-nutritive microvascular blood flow and vasomotion unchanged.
CONCLUSIONS


After the intake of a lipid-rich meal, the use of vildagliptin preserved postprandial non-nutritive microflow and vasomotion, while metformin increased capillary recruitment, suggesting protective and different mechanisms of action on microcirculation.",2020,Vildagliptin increased glucagon-like peptide-1 compared to metformin.,"['Patients with Type 2 Diabetes and Obesity', '38 drug-naïve patients, all women aged between 19 and 50 years, with BMI ≥ 30 kg/m 2 ', 'patients with type 2 diabetes and obesity', 'healthy subjects']","['vildagliptin', 'Vildagliptin', 'metformin or vildagliptin', 'metformin', 'Metformin and Vildagliptin', 'lipid-rich meal', 'videocapillaroscopy and laser-Doppler flowmetry', 'Lipid-Rich Meal', 'Metformin']","['plasma viscosity, inflammatory and oxidative stress biomarkers, gastrointestinal peptides, and metabolic profile', 'metabolic profile, oxidative stress, inflammation, plasma viscosity, and some gastrointestinal peptides', 'Postprandial Microvascular Reactivity', 'functional capillary density, while vildagliptin kept non-nutritive microvascular blood flow and vasomotion unchanged', 'plasma glucose solely', 'Endothelial function', 'levels of insulin and glucagon-like peptide-1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3652744', 'cui_str': 'metformin and vildagliptin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C4045986', 'cui_str': 'Videocapillaroscopy'}, {'cui': 'C0162520', 'cui_str': 'Laser doppler flowmetry'}]","[{'cui': 'C0427685', 'cui_str': 'Plasma viscosity measurement'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0442739', 'cui_str': 'No status change'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]",,0.0239451,Vildagliptin increased glucagon-like peptide-1 compared to metformin.,"[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Schiappacassa', 'Affiliation': 'Post-Graduate Program in Clinical and Experimental Physiopathology (FISCLINEX), Faculty of Medical Sciences, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.'}, {'ForeName': 'Priscila A', 'Initials': 'PA', 'LastName': 'Maranhão', 'Affiliation': 'Post-Graduate Program in Clinical and Experimental Physiopathology (FISCLINEX), Faculty of Medical Sciences, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.'}, {'ForeName': 'Maria das Graças Coelho de', 'Initials': 'MDGC', 'LastName': 'Souza', 'Affiliation': 'Post-Graduate Program in Clinical and Experimental Physiopathology (FISCLINEX), Faculty of Medical Sciences, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.'}, {'ForeName': 'Diogo G', 'Initials': 'DG', 'LastName': 'Panazzolo', 'Affiliation': 'Post-Graduate Program in Clinical and Experimental Physiopathology (FISCLINEX), Faculty of Medical Sciences, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.'}, {'ForeName': 'José Firmino', 'Initials': 'JF', 'LastName': 'Nogueira Neto', 'Affiliation': 'Lipids Laboratory (Lablip), Policlínica Piquet Carneiro, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-003, Brazil.'}, {'ForeName': 'Eliete', 'Initials': 'E', 'LastName': 'Bouskela', 'Affiliation': 'Laboratory of Clinical and Experimental Research on Vascular Biology (BioVasc), Biomedical Center, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.'}, {'ForeName': 'Luiz Guilherme', 'Initials': 'LG', 'LastName': 'Kraemer-Aguiar', 'Affiliation': 'Laboratory of Clinical and Experimental Research on Vascular Biology (BioVasc), Biomedical Center, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.'}]",Journal of clinical medicine,['10.3390/jcm9103228']
2464,33050179,Effectiveness of a Physical Therapeutic Exercise Programme for Caregivers of Dependent Patients: A Pragmatic Randomised Controlled Trial from Spanish Primary Care.,"Female family caregivers (FFCs) constitute one of the basic supports of socio-health care for dependence in developed countries. The care provided by FFCs may impact their physical and mental health, negatively affecting their quality of life. In order to alleviate the consequences of providing care on FFCs, the Spanish Public Health System has developed the family caregiver care programme (FCCP) to be applied in primary care (PC) centres. The effectiveness of this programme is limited. To date, the addition of a physical therapeutic exercise (PTE) programme to FCCP has not been evaluated. A randomised multicentre clinical trial was carried out in two PC centres of the Spanish Public Health System. In total, 68 FFCs were recruited. The experimental group (EG) performed the usual FCCP (4 sessions, 6 h) added to a PTE programme (36 sessions in 12 weeks) whereas the control group performed the usual FCCP performed in PC. The experimental treatment improved quality of life (d = 1.17 in physical component summary), subjective burden (d = 2.38), anxiety (d = 1.52), depression (d = 1.37) and health-related physical condition (d = 2.44 in endurance). Differences between the groups ( p  < 0.05) were clinically relevant in favour of the EG. The experimental treatment generates high levels of satisfaction.",2020,"The experimental treatment improved quality of life (d = 1.17 in physical component summary), subjective burden (d = 2.38), anxiety (d = 1.52), depression (d = 1.37) and health-related physical condition (d = 2.44 in endurance).","['Caregivers of Dependent Patients', 'two PC centres of the Spanish Public Health System', 'In total, 68 FFCs were recruited', 'Female family caregivers (FFCs']","['physical therapeutic exercise (PTE) programme', 'usual FCCP (4 sessions, 6 h) added to a PTE programme', 'usual FCCP performed in PC', 'Physical Therapeutic Exercise Programme']","['health-related physical condition', 'quality of life', 'subjective burden', 'anxiety']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",68.0,0.0437757,"The experimental treatment improved quality of life (d = 1.17 in physical component summary), subjective burden (d = 2.38), anxiety (d = 1.52), depression (d = 1.37) and health-related physical condition (d = 2.44 in endurance).","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Montero-Cuadrado', 'Affiliation': 'Unit for Active Coping Strategies for Pain in Primary Care, East-Valladolid Primary Care Management, Castilla and Leon Public Health System (Sacyl), 47011 Valladolid, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Galán-Martín', 'Affiliation': 'Unit for Active Coping Strategies for Pain in Primary Care, East-Valladolid Primary Care Management, Castilla and Leon Public Health System (Sacyl), 47011 Valladolid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sánchez-Sánchez', 'Affiliation': 'Department of Physical Activity and Sports Sciences, University Pontificia of Salamanca, 37002 Salamanca, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Lluch', 'Affiliation': 'Department of Physical Therapy, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Mayo-Iscar', 'Affiliation': 'Department of Statistics and Operational Research and IMUVA, University of Valladolid, 47005 Valladolid, Spain.'}, {'ForeName': 'Ántonio', 'Initials': 'Á', 'LastName': 'Cuesta-Vargas', 'Affiliation': 'Department of Physiotherapy, Faculty of Heath Sciences, University of Malaga, 19071 Málaga, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17207359']
2465,33050205,Rifabutin-Containing Triple Therapy (RHB-105) for Eradication of  Helicobacter pylori : Randomized ERADICATE Hp Trial.,"Due to increasing resistance to commonly used antibiotics, the World Health Organization and Food and Drug Administration have advocated the development of new therapeutic regimens for  Helicobacter pylori (H. pylori) . This phase three, double-blind study (ERADICATE Hp) randomized (2:1) treatment-naïve adults with  H. pylori  infection and dyspepsia to RHB-105 (an all-in-one combination of omeprazole 40 mg, amoxicillin 1000 mg, and rifabutin 50 mg) or an identically-appearing placebo, both administered every 8 h for 14 days. The  H. pylori  eradication rate with RHB-105, using a modified intent-to-treat (mITT) population of subjects who received ≥1 dose of study drug and had test-of-eradication performed 28-35 days post-completion of therapy, was compared (one-sample  Z -test) to a literature-derived comparator rate of 70% and success rate with physician-selected standard-of-care given to placebo failures. The mITT  H. pylori  eradication rate (95% CI) with RHB-105 of 89.4% (82.0-96.8%) was greater than both the literature-derived comparator rate ( P  < 0.001) and the standard-of-care rate of 63.0% (44.8-81.1%) ( P  = 0.006). Adverse events with an incidence ≥5% for RHB-105 were diarrhea (12.7%), headache (11.9%), chromaturia (9.3%), abdominal tenderness (6.8%), and dizziness (5.1%). No leukopenia was noted. RHB-105 (Talicia ® ) proved to be a safe and effective empiric therapy for  H. pylori  eradication.",2020,"The  H. pylori  eradication rate with RHB-105, using a modified intent-to-treat (mITT) population of subjects who received ≥1 dose of study drug and had test-of-eradication performed 28-35 days post-completion of therapy, was compared (one-sample  Z -test) to a literature-derived comparator rate of 70% and success rate with physician-selected standard-of-care given to placebo failures.",['naïve adults with  H. pylori  infection and dyspepsia to RHB-105 (an all-in-one combination of'],"['omeprazole 40 mg, amoxicillin 1000 mg, and rifabutin 50 mg) or an identically-appearing placebo', 'Rifabutin-Containing Triple Therapy (RHB-105', 'RHB-105 (Talicia ® ']","['headache', 'diarrhea', 'leukopenia', 'standard-of-care rate', 'Adverse events', 'eradication rate', 'dizziness', 'abdominal tenderness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0992678', 'cui_str': 'Omeprazole 40 MG'}, {'cui': 'C1126881', 'cui_str': 'Amoxicillin 1000 MG'}, {'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0232498', 'cui_str': 'Abdominal tenderness'}]",,0.299334,"The  H. pylori  eradication rate with RHB-105, using a modified intent-to-treat (mITT) population of subjects who received ≥1 dose of study drug and had test-of-eradication performed 28-35 days post-completion of therapy, was compared (one-sample  Z -test) to a literature-derived comparator rate of 70% and success rate with physician-selected standard-of-care given to placebo failures.","[{'ForeName': 'Ira N', 'Initials': 'IN', 'LastName': 'Kalfus', 'Affiliation': 'Independent Consultant, M2g Consulting, 251 Central Park West, New York, NY 10024, USA.'}, {'ForeName': 'David Y', 'Initials': 'DY', 'LastName': 'Graham', 'Affiliation': 'Department of Medicine, Michael E. DeBakey VA Medical Center and Baylor College of Medicine, 2002 Holcombe Boulevard, Houston, TX 77030, USA.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Riff', 'Affiliation': 'Anaheim Clinical Trials, 1085 N. Harbor Blvd, Anaheim, CA 92801, USA.'}, {'ForeName': 'Raymond M', 'Initials': 'RM', 'LastName': 'Panas', 'Affiliation': 'Medical Affairs, RedHill Biopharma, Inc., 8045 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, USA.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9100685']
2466,33050250,Mechanisms Underlying the Inhibition of Tyrosine Kinase Inhibitor-Induced Anorexia and Fatigue by Royal Jelly in Renal Cell Carcinoma Patients and the Correlation between Macrophage Colony Stimulating Factor and Inflammatory Mediators.,"Inflammation is a common adverse event of anti-cancer therapy. Royal jelly (RJ) modulates inflammation by regulating the levels of tumor necrosis factor (TNF)-α, transforming growth factor (TGF)-β, and interleukin (IL)-6 produced by macrophages. Macrophage colony stimulating factor (M-CSF) is a crucial regulator of macrophage activities, and we hypothesized that RJ alters M-CSF levels. In this randomized controlled trial, we investigated the association between M-CSF and adverse events in renal cell carcinoma patients treated with tyrosine kinase inhibitors (TKIs) after an oral intake of RJ ( n  = 16) or placebo ( n  = 17). The serum levels of M-CSF, TNF-α, TGF-β, and IL-6 were measured by an enzyme-linked immunosorbent assay, and their temporal changes and correlation between such changes were analyzed. The post-/pretreatment ratio of M-CSF levels was associated with anorexia after 2 weeks and fatigue after 2, 4, and 12 weeks. The M-CSF level in the RJ group was higher than that in the placebo group at the same timepoints. The TNF-α level in the RJ group was lower than that in the placebo group between 6 and 12 weeks, and the TGF-β level in the RJ group was higher than that in the placebo group; however, contrasting findings were detected after 12 weeks. Additionally, the M-CSF level was significantly correlated with the TGF-β level after 4 weeks and IL-6 level after 8 and 10 weeks. Among TNF-α, TGF-β, and IL-6, the post-/pretreatment ratio of TGF-β after 12 weeks was associated with TKI-induced anorexia, and the ratios after 10 and 12 weeks were associated with fatigue. Our results demonstrated that an oral intake of RJ suppressed anorexia and fatigue via complex mechanisms associated with inflammation-related factors, such as M-CSF and TGF-β in renal cell carcinoma patients treated with TKIs. In addition, we newly found that such RJ-related effects were dependent on the treatment duration.",2020,"The TNF-α level in the RJ group was lower than that in the placebo group between 6 and 12 weeks, and the TGF-β level in the RJ group was higher than that in the placebo group; however, contrasting findings were detected after 12 weeks.","['Renal Cell Carcinoma Patients', 'renal cell carcinoma patients treated with tyrosine kinase inhibitors (TKIs) after an oral intake of RJ ( n  = 16) or', 'renal cell carcinoma patients treated with TKIs', ' n  = 17']","['placebo', 'Royal jelly (RJ']","['serum levels of M-CSF, TNF-α, TGF-β, and IL-6', 'TNF-α, TGF-β, and IL-6, the post-/pretreatment ratio of TGF-β', 'levels of tumor necrosis factor (TNF)-α, transforming growth factor (TGF)-β, and interleukin (IL)-6', 'TNF-α level', 'post-/pretreatment ratio of M-CSF levels', 'M-CSF level', 'TGF-β level', 'IL-6 level']","[{'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0073603', 'cui_str': 'royal jelly'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073603', 'cui_str': 'royal jelly'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0488929,"The TNF-α level in the RJ group was lower than that in the placebo group between 6 and 12 weeks, and the TGF-β level in the RJ group was higher than that in the placebo group; however, contrasting findings were detected after 12 weeks.","[{'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Yuno', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Yasuyoshi', 'Initials': 'Y', 'LastName': 'Miyata', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Mukae', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Asato', 'Initials': 'A', 'LastName': 'Otsubo', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Mitsunari', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Matsuo', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Ohba', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Sakai', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}]","Medical sciences (Basel, Switzerland)",['10.3390/medsci8040043']
2467,33046465,Effectiveness and cost-effectiveness of a virtual community of practice to improve the empowerment of patients with ischaemic heart disease: study protocol of a randomised controlled trial.,"INTRODUCTION


Virtual Communities of Practice (VCoP) or knowledge-sharing virtual communities offer ubiquitous access to information and exchange possibilities for people in similar situations, which might be especially valuable for the self-management of patients with chronic diseases. In view of the scarce evidence on the clinical and economic impact of these interventions on chronic conditions, we aim to evaluate the effectiveness and cost-effectiveness of a VCoP in the improvement of the activation and other patient empowerment measures in patients with ischaemic heart disease (IHD).
METHODS AND ANALYSIS


A pragmatic randomised controlled trial will be performed in Catalonia, Madrid and Canary Islands, Spain. Two hundred and fifty patients with a recent diagnosis of IHD attending the participating centres will be selected and randomised to the intervention or control group. The intervention group will be offered participation for 12 months in a VCoP based on a gamified web 2.0 platform where there is interaction with other patients and a multidisciplinary professional team. Intervention and control groups will receive usual care. The primary outcome will be measured with the Patient Activation Measure questionnaire at baseline, 6, 12 and 18 months. Secondary outcomes will include: clinical variables; knowledge (Questionnaire of Cardiovascular Risk Factors), attitudes (Self-efficacy Managing Chronic Disease Scale), adherence to the Mediterranean diet (Mediterranean Diet Questionnaire), level of physical activity (International Physical Activity Questionnaire), depression (Patient Health Questionnaire), anxiety (Hospital Anxiety Scale-A), medication adherence (Adherence to Refill Medication Scale), quality of life (EQ-5D-5L) and health resources use. Data will be collected from self-reported questionnaires and electronic medical records.
ETHICS AND DISSEMINATION


The trial was approved by Clinical Research Ethics Committee of Gregorio Marañón University Hospital in Madrid, Nuestra Señora de Candelaria University Hospital in Santa Cruz de Tenerife and IDIAP Jordi Gol in Barcelona. The results will be disseminated through workshops, policy briefs, peer-reviewed publications, local/international conferences.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03959631). Pre-results.",2020,"INTRODUCTION


Virtual Communities of Practice (VCoP) or knowledge-sharing virtual communities offer ubiquitous access to information and exchange possibilities for people in similar situations, which might be especially valuable for the self-management of patients with chronic diseases.","['Gregorio Marañón University Hospital in Madrid, Nuestra Señora de Candelaria University Hospital in Santa Cruz de Tenerife and IDIAP Jordi Gol in Barcelona', 'patients with chronic diseases', 'patients with ischaemic heart disease (IHD', 'patients with ischaemic heart disease', 'Two hundred and fifty patients with a recent diagnosis of IHD attending the participating centres']",['VCoP'],"['Patient Activation Measure questionnaire', 'effectiveness and cost-effectiveness', ' clinical variables; knowledge (Questionnaire of Cardiovascular Risk Factors), attitudes (Self-efficacy Managing Chronic Disease Scale), adherence to the Mediterranean diet (Mediterranean Diet Questionnaire), level of physical activity (International Physical Activity Questionnaire), depression (Patient Health Questionnaire), anxiety (Hospital Anxiety Scale-A), medication adherence (Adherence to Refill Medication Scale), quality of life (EQ-5D-5L) and health resources use', 'Effectiveness and cost-effectiveness']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0454686', 'cui_str': 'Tenerife'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",250.0,0.140729,"INTRODUCTION


Virtual Communities of Practice (VCoP) or knowledge-sharing virtual communities offer ubiquitous access to information and exchange possibilities for people in similar situations, which might be especially valuable for the self-management of patients with chronic diseases.","[{'ForeName': 'Ana Isabel', 'Initials': 'AI', 'LastName': 'González-González', 'Affiliation': 'Goethe-Universitat Frankfurt am Main Institut fur Allgemeinmedizin, Frankfurt am Main, Hessen, Germany gonzalezgonzalez@allgemeinmedizin.uni-frankfurt.de.'}, {'ForeName': 'Lilisbeth', 'Initials': 'L', 'LastName': 'Perestelo-Pérez', 'Affiliation': 'Servicio de Evaluación y Planificación del Servicio Canario de la Salud, Tenerife, Spain.'}, {'ForeName': 'Débora', 'Initials': 'D', 'LastName': 'Koatz', 'Affiliation': 'Avedis Donabedian Research Institute (FAD), Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ballester', 'Affiliation': 'Avedis Donabedian Research Institute (FAD), Barcelona, Spain.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Pacheco-Huergo', 'Affiliation': 'Avedis Donabedian Research Institute (FAD), Barcelona, Spain.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Ramos-García', 'Affiliation': 'Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FISC), Tenerife, Spain.'}, {'ForeName': 'Alezandra', 'Initials': 'A', 'LastName': 'Torres-Castaño', 'Affiliation': 'Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FISC), Tenerife, Spain.'}, {'ForeName': 'Amado', 'Initials': 'A', 'LastName': 'Rivero-Santana', 'Affiliation': 'Servicio de Evaluación y Planificación del Servicio Canario de la Salud, Tenerife, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Toledo-Chávarri', 'Affiliation': 'Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Tenerife, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Valcárcel-Nazco', 'Affiliation': 'Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FISC), Tenerife, Spain.'}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Mateos-Rodilla', 'Affiliation': 'Escuela Madrileña de Salud, Dirección General de Humanización y Atención al Paciente, Madrid, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Obaya-Rebollar', 'Affiliation': 'Centro de Salud Chopera, Gerencia Asistencial de Atención Primaria, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'García-García', 'Affiliation': 'Unidad de Calidad y Seguridad del Paciente. Hospital Universitario Nuestra Señora de Candelaria, Tenerife, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Díaz-Sánchez', 'Affiliation': 'Centro de Salud Pintores, Gerencia Asistencial de Atención Primaria, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Morales-Cobos', 'Affiliation': 'Centro de Salud Las Américas, Gerencia Asistencial de Atención Primaria, Madrid, Spain.'}, {'ForeName': 'Josep María', 'Initials': 'JM', 'LastName': 'Bosch-Fontcuberta', 'Affiliation': 'Centro de Atención Primaria Encants, Instituto Catalán de la Salud, Barcelona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Vallejo-Camazón', 'Affiliation': 'Hospital Germans Trias i Pujol, Badalona, Catalunya, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rodríguez-Almodovar', 'Affiliation': 'UGC Cardiología, Hospital Universitario Reina Sofía, Códoba, Spain.'}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Del Castillo', 'Affiliation': 'Cardiovascular Area, Hospital San Juan de Dios, Tenerife, Canarias, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Muñoz-Balsa', 'Affiliation': 'Unidad de Apoyo Técnico, Gerencia Asistencial Atención Primaria, Servicio Madrileño de Salud, Madrid, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Del Rey-Granado', 'Affiliation': 'Unidad de Apoyo Técnico, Gerencia Asistencial Atención Primaria, Servicio Madrileño de Salud, Madrid, Spain.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Garrido-Elustondo', 'Affiliation': 'Centre Family and Community Care Teaching Multiprofessional Unit, Comunidad de Madrid Consejeria de Sanidad, Madrid, Spain.'}, {'ForeName': 'María-Eugenia', 'Initials': 'ME', 'LastName': 'Tello-Bernabé', 'Affiliation': 'Centro de Salud El Naranjo, Gerencia Asistencial Atención Primaria, Servicio Madrileño de Salud, Madrid, Spain.'}, {'ForeName': 'Ana Belén', 'Initials': 'AB', 'LastName': 'Ramírez-Puerta', 'Affiliation': 'Unidad de Apoyo Técnico, Gerencia Asistencial Atención Primaria, Servicio Madrileño de Salud, Madrid, Spain.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Orrego', 'Affiliation': 'Avedis Donabedian Research Institute (FAD), Barcelona, Spain.'}]",BMJ open,['10.1136/bmjopen-2020-037374']
2468,33046475,Effects of a power strength training using elastic resistance exercises on the motor and non-motor symptoms in patients with Parkinson's disease H&Y 1-3: study protocol for a randomised controlled trial (PARK-BAND Study).,"INTRODUCTION


Parkinson's disease (PD) is the second most common neurodegenerative disorder in Brazil. Physical activity is a complementary intervention in managing inherent declines associated with the disease like strength, balance, gait, and functionality and benefit health-related outcomes. Here, we report the PARK-BAND Study protocol, which aims to investigate potential benefits of power training using elastic devices in participants with PD. Our intervention will be provided in patients with PD using elastic devices like elastic bands and tubes. Therefore, we used the term Park from Parkinson's disease and band from elastic bands.
METHODS AND ANALYSIS


This randomised single-blind single-centre two-arm parallel, superiority trial will include 50 participants with PD attending the clinical setting. Those who meet the eligibility criteria and provide consent to participate will be randomised in a 1:1 ratio to either the exercise group, which will receive power training programme or the health education group, which will receive the education programme. Randomisation will be performed by permuted block randomisation with a block size of eight. Both groups will receive a 12-week intervention. The exercise group will have two sessions per week and the health education group will have one session per week. Changes from baseline in bradykinesia, as assessed by the Unified Parkinson's Disease Rating Scale motor examination subscore and physical functional performance, will be the primary outcomes. Secondary outcomes include other neurological, neurophysiological and physical variables, as well as the quality of life, depression, cognition, sleep quality and disturbances, assessed before and after interventions. We hypothesise that the exercise group will have greater improvement in primary and secondary outcomes than the health education group.
ETHICS AND DISSEMINATION


The study is approved by the Research Ethics Committee of Hospital Universitário Walter Cantidio and all participants will provide their written informed consent (register number 91075318.1.0000.5045).Trial results will be disseminated via peer reviewed journal articles and conference presentations, reports for organisations involved with PD and for participants.
TRIAL REGISTRATION NUMBER


Registro Brasileiro de Ensaios Clínicos Registry (RBR-5w2sqt); Pre-results.",2020,"Changes from baseline in bradykinesia, as assessed by the Unified Parkinson's Disease Rating Scale motor examination subscore and physical functional performance, will be the primary outcomes.","['50 participants with PD attending the clinical setting', ""patients with Parkinson's disease H&Y 1-3"", 'participants with PD']","['power training using elastic devices', 'power training programme or the health education group, which will receive the education programme', 'power strength training using elastic resistance exercises']","[""Unified Parkinson's Disease Rating Scale motor examination subscore and physical functional performance"", 'motor and non-motor symptoms', 'neurological, neurophysiological and physical variables, as well as the quality of life, depression, cognition, sleep quality and disturbances, assessed before and after interventions']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4704690', 'cui_str': 'Physical Functional Performance'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",50.0,0.0963442,"Changes from baseline in bradykinesia, as assessed by the Unified Parkinson's Disease Rating Scale motor examination subscore and physical functional performance, will be the primary outcomes.","[{'ForeName': 'Danielle Pessoa', 'Initials': 'DP', 'LastName': 'Lima', 'Affiliation': 'Geriatric Division, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil dra.daniellelima@gmail.com.'}, {'ForeName': 'Samuel Brito', 'Initials': 'SB', 'LastName': 'de Almeida', 'Affiliation': 'Clinical Research Unit, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Janine de Carvalho', 'Initials': 'JC', 'LastName': 'Bonfadini', 'Affiliation': 'Clinical Research Unit, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Emmanuelle Silva Tavares', 'Initials': 'EST', 'LastName': 'Sobreira', 'Affiliation': 'Clinical Research Unit, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Patrícia Gomes', 'Initials': 'PG', 'LastName': 'Damasceno', 'Affiliation': 'Division of Neurology, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Antonio Brazil', 'Initials': 'AB', 'LastName': 'Viana Júnior', 'Affiliation': 'Clinical Research Unit, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Madeleine Sales', 'Initials': 'MS', 'LastName': 'de Alencar', 'Affiliation': 'Geriatric Division, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'João Rafael Gomes', 'Initials': 'JRG', 'LastName': 'de Luna', 'Affiliation': 'Geriatric Division, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Pedro Gustavo Barros', 'Initials': 'PGB', 'LastName': 'Rodrigues', 'Affiliation': 'Medical School, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Isabelle de Sousa', 'Initials': 'IS', 'LastName': 'Pereira', 'Affiliation': 'Medical School, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'André Luis de Castro', 'Initials': 'ALC', 'LastName': 'Gadelha', 'Affiliation': 'Psychology School, Universidade de Fortaleza, Centro de Ciências da Saúde, Fortaleza, Brazil.'}, {'ForeName': 'Liliane Maria', 'Initials': 'LM', 'LastName': 'de Oliveira', 'Affiliation': 'School of Kinesiology, Universidade Estácio de Sá Sistema Integrado de Bibliotecas do Centro Universitário Estácio do Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Érica Carneiro Barbosa', 'Initials': 'ÉCB', 'LastName': 'Chaves', 'Affiliation': 'School of Kinesiology, Universidade Estácio de Sá Sistema Integrado de Bibliotecas do Centro Universitário Estácio do Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Vlademir Gomes', 'Initials': 'VG', 'LastName': 'Carneiro', 'Affiliation': 'School of Kinesiology, Universidade Federal da Paraíba, Joao Pessoa, Brazil.'}, {'ForeName': 'Rayane Rodrigues', 'Initials': 'RR', 'LastName': 'Monteiro', 'Affiliation': 'School of Kinesiology, Universidade Estácio de Sá Sistema Integrado de Bibliotecas do Centro Universitário Estácio do Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Thatyara Almeida de Macedo', 'Initials': 'TAM', 'LastName': 'Costa', 'Affiliation': 'School of Nutrition, Universidade Estácio de Sá Sistema Integrado de Bibliotecas do Centro Universitário Estácio do Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Helal', 'Affiliation': 'School of Kinesiology, Universidade do Extremo Sul Catarinense, Criciuma, Brazil.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Signorile', 'Affiliation': 'Kinesiology and Sport Sciences, University of Miami, Coral Gables, Florida, USA.'}, {'ForeName': 'Lidiane Andréa Oliveira', 'Initials': 'LAO', 'LastName': 'Lima', 'Affiliation': 'Department of Physiotherapy, Universidade Federal do Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Manoel Alves', 'Initials': 'MA', 'LastName': 'Sobreira-Neto', 'Affiliation': 'Division of Neurology, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Braga-Neto', 'Affiliation': 'Division of Neurology, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}]",BMJ open,['10.1136/bmjopen-2020-039941']
2469,33046478,Protocol of a randomised controlled trial on the efficacy of medication optimisation in elderly inpatients: medication optimisation protocol efficacy for geriatric inpatients (MPEG) trial.,"INTRODUCTION


Whether medication optimisation improves clinical outcomes in elderly individuals remains unclear. The current study aims to evaluate the effect of multidisciplinary team-based medication optimisation on survival, rehospitalisation and unscheduled hospital visits in elderly patients.
METHODS AND ANALYSIS


We report the protocol of a single-centre, open-label, randomised controlled trial. The enrolled subjects will be medical inpatients, aged 65 years or older, admitted to a community hospital and receiving five or more regular medications. The participants will be randomly assigned to receive either an intervention for medication optimisation or the usual care. The intervention will consist of a multidisciplinary team-based medication review, followed by a medication optimisation proposal based on the Screening Tool of Older Persons' potentially inappropriate Prescriptions/Screening Tool to Alert doctors to the Right Treatment criteria and an implicit medication optimisation protocol. Medication optimisation summaries will be sent to primary care physicians and community pharmacists on discharge. The primary outcome will be a composite of death, unscheduled hospital visits and rehospitalisation until 48 weeks after randomisation. Secondary outcomes will include each of the primary endpoints, the number of prescribed medications, quality of life score, level of long-term care required, drug-related adverse events, death during hospitalisation and falls. Participants will be followed up for 48 weeks with bimonthly telephone interviews to assess the primary and secondary outcomes. A log-rank test stratified by randomisation factors will be used to compare the incidence of the composite endpoint. The study was initiated in 2019 and a minimum of 500 patients will be enrolled.
ETHICS AND DISSEMINATION


The study protocol has been approved by the Institutional Ethical Committee of St. Marianna University School of Medicine (No. 4129). The results of the current study will be submitted to a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


UMIN000035265.",2020,"The primary outcome will be a composite of death, unscheduled hospital visits and rehospitalisation until 48 weeks after randomisation.","['elderly inpatients', 'elderly patients', 'enrolled subjects will be medical inpatients, aged 65 years or older, admitted to a community hospital and receiving five or more regular medications', '500 patients will be enrolled', 'elderly individuals', 'geriatric inpatients (MPEG) trial']","['multidisciplinary team-based medication optimisation', 'intervention for medication optimisation or the usual care']","['survival, rehospitalisation and unscheduled hospital visits', 'composite of death, unscheduled hospital visits and rehospitalisation until 48 weeks after randomisation', 'number of prescribed medications, quality of life score, level of long-term care required, drug-related adverse events, death during hospitalisation and falls']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",,0.142518,"The primary outcome will be a composite of death, unscheduled hospital visits and rehospitalisation until 48 weeks after randomisation.","[{'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Ie', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan kenya.ie@marianna-u.ac.jp.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Hirose', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, St Marianna University School of Medicine, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Tsubasa', 'Initials': 'T', 'LastName': 'Sakai', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Iori', 'Initials': 'I', 'LastName': 'Motohashi', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Aihara', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Otsuki', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Tsuboya', 'Affiliation': 'Department of Pharmacy, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Pharmacy, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Hikari', 'Initials': 'H', 'LastName': 'Hashi', 'Affiliation': 'Department of Pharmacy, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Inoue', 'Affiliation': 'Showa University Research Administration Center, Showa University, Shinagawa-ku, Tokyo, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Division of Medical Informatics, St. Marianna University School of Medicine, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Eiko', 'Initials': 'E', 'LastName': 'Komiya', 'Affiliation': 'Department of Pharmacy, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Itoh', 'Affiliation': 'Department of Pharmacy, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Tsuchida', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, St Marianna University School of Medicine, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Kurosu', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Albert', 'Affiliation': 'Department of Behavioral and Community Health Sciences, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Okuse', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Takahide', 'Initials': 'T', 'LastName': 'Matsuda', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, St Marianna University School of Medicine, Kawasaki-shi, Kanagawa, Japan.'}]",BMJ open,['10.1136/bmjopen-2020-041125']
2470,33046528,Cluster cross-over randomised trial of paediatric airway management devices in the simulation lab and operating room among paramedic students.,"OBJECTIVES


The objective of this study was to compare paediatric emergency airway management strategies in the simulation lab and operating room environments.
METHODS


This was a two-part cluster cross-over randomised trial including simulation lab and operating room environments conducted between January 2017 and June 2018 in Portland, Oregon, USA. In simulated infant cardiac arrests, paramedic students placed an endotracheal tube, an i-gel or a laryngeal mask airway in random order. In the operating room, paramedic students placed a laryngeal mask airway or i-gel device in random order in sequential patients. The primary outcome for both portions of the study was time to ventilation. In the operating room portion, we also evaluated leak pressures and average initial tidal volumes.
RESULTS


There were 58 paramedic students who participated in the simulation lab and 22 who participated in the operating room study. The mean time to airway placement in the simulation lab was 48.5 s for the i-gel, 68.9 s for the laryngeal mask and 129.5 s for the endotracheal tube. In the operating room, mean time to i-gel placement was 34.3 s with 45.2 s for the laryngeal mask. In multivariable analysis of the simulation study, the laryngeal mask and i-gel were significantly faster than the endotracheal tube, and the i-gel was faster than the laryngeal mask. In the operating room, there was no significant difference in time to placement, leak pressure and average volume of the first five breaths between the i-gel and laryngeal mask.
CONCLUSIONS


We found that paramedic students were able to place supraglottic devices rapidly with high success rates in simulation lab and operating room environments. Supraglottic devices, particularly the i-gel, were rated as easy to use. The i-gel may be easiest to use since it lacks an inflable cuff and requires fewer steps to place.",2020,We found that paramedic students were able to place supraglottic devices rapidly with high success rates in simulation lab and operating room environments.,"['58 paramedic students who participated in the simulation lab and 22 who participated in the operating room study', 'paramedic students']",[],"['time to placement, leak pressure and average volume of the first five breaths', 'mean time to airway placement', 'time to ventilation', 'leak pressures and average initial tidal volumes']","[{'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}]",,0.0254939,We found that paramedic students were able to place supraglottic devices rapidly with high success rates in simulation lab and operating room environments.,"[{'ForeName': 'Matthew Lee', 'Initials': 'ML', 'LastName': 'Hansen', 'Affiliation': 'Emergency Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA hansemat@ohsu.edu.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Wagner', 'Affiliation': 'Oregon Institute of Technology, Wilsonville, Oregon, United States.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Schnapp', 'Affiliation': 'Emergency Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'Emergency Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Le', 'Affiliation': 'Emergency Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Deverman', 'Affiliation': 'Anesthesiology and Peri-operative Medicine, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Pedigo', 'Affiliation': 'Anesthesiology and Peri-operative Medicine, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': 'Anesthesiology and Peri-operative Medicine, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Cusick', 'Affiliation': 'Anesthesiology and Peri-operative Medicine, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Gries', 'Affiliation': 'Anesthesiology and Peri-operative Medicine, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Anesthesiology and Peri-operative Medicine, Oregon Health & Science University, Portland, Oregon, USA.'}]",Emergency medicine journal : EMJ,['10.1136/emermed-2020-209929']
2471,33046573,PORTEC-4a: international randomized trial of molecular profile-based adjuvant treatment for women with high-intermediate risk endometrial cancer.,"BACKGROUND


Vaginal brachytherapy is currently recommended as adjuvant treatment in patients with high-intermediate risk endometrial cancer to maximize local control and has only mild side effects and no or limited impact on quality of life. However, there is still considerable overtreatment and also some undertreatment, which may be reduced by tailoring adjuvant treatment to the patients' risk of recurrence based on molecular tumor characteristics.
PRIMARY OBJECTIVES


To compare the rates of vaginal recurrence in women with high-intermediate risk endometrial cancer, treated after surgery with molecular-integrated risk profile-based recommendations for either observation, vaginal brachytherapy or external pelvic beam radiotherapy or with standard adjuvant vaginal brachytherapy STUDY HYPOTHESIS: Adjuvant treatment based on a molecular-integrated risk profile provides similar local control and recurrence-free survival as current standard adjuvant brachytherapy in patients with high-intermediate risk endometrial cancer, while sparing many patients the morbidity of adjuvant treatment and reducing healthcare costs.
TRIAL DESIGN


A multicenter, international phase III randomized trial (2:1) of molecular-integrated risk profile-based adjuvant treatment (experimental arm) or adjuvant vaginal brachytherapy (standard arm).
MAJOR INCLUSION/EXCLUSION CRITERIA


Women aged 18 years and over with a histological diagnosis of high-intermediate risk endometrioid endometrial cancer after total abdominal or laparoscopic hysterectomy and bilateral salpingo-oophorectomy. High-intermediate risk factors are defined as: (i) International Federation of Gynecology and Obstetrics stage IA (with invasion) and grade 3; (ii) stage IB grade 1 or 2 with age ≥60 and/or lymph-vascular space invasion; (iii) stage IB, grade 3 without lymph-vascular space invasion; or (iv) stage II (microscopic and grade 1).
ENDPOINTS


The primary endpoint is vaginal recurrence. Secondary endpoints are recurrence-free and overall survival; pelvic and distant recurrence; 5-year vaginal control (including treatment for relapse); adverse events and patient-reported symptoms and quality of life; and endometrial cancer-related healthcare costs.
SAMPLE SIZE


500 eligible and evaluable patients.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS


Estimated date for completing accrual will be late 2021. Estimated date for presentation of (first) results is expected in 2023.
TRIAL REGISTRATION


The trial is registered at clinicaltrials.gov (NCT03469674) and ISRCTN (11659025).",2020,"Adjuvant treatment based on a molecular-integrated risk profile provides similar local control and recurrence-free survival as current standard adjuvant brachytherapy in patients with high-intermediate risk endometrial cancer, while sparing many patients the morbidity of adjuvant treatment and reducing healthcare costs.
","['patients with high-intermediate risk endometrial cancer', 'women with high-intermediate risk endometrial cancer, treated after surgery with molecular-integrated risk profile-based recommendations for either observation', 'women with high-intermediate risk endometrial cancer', '500 eligible and evaluable patients', 'Women aged 18 years and over with a histological diagnosis of high-intermediate risk endometrioid endometrial cancer after total abdominal or', 'grade 3; (ii) stage IB grade 1 or 2 with age ≥60 and/or lymph-vascular space invasion; (iii) stage IB, grade 3 without lymph-vascular space invasion; or (iv) stage II (microscopic and grade 1']","['vaginal brachytherapy or external pelvic beam radiotherapy or with standard adjuvant vaginal brachytherapy', 'molecular-integrated risk profile-based adjuvant treatment (experimental arm) or adjuvant vaginal brachytherapy (standard arm', 'laparoscopic hysterectomy and bilateral salpingo-oophorectomy', 'Vaginal brachytherapy']","['rates of vaginal recurrence', 'vaginal recurrence', 'recurrence-free and overall survival; pelvic and distant recurrence; 5-year vaginal control (including treatment for relapse); adverse events and patient-reported symptoms and quality of life; and endometrial cancer-related healthcare costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0456597', 'cui_str': 'Stage 1B'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0024202', 'cui_str': 'Lymph'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}]","[{'cui': 'C0854674', 'cui_str': 'Brachytherapy to vagina'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0195495', 'cui_str': 'Bilateral salpingectomy with oophorectomy'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}]",500.0,0.16568,"Adjuvant treatment based on a molecular-integrated risk profile provides similar local control and recurrence-free survival as current standard adjuvant brachytherapy in patients with high-intermediate risk endometrial cancer, while sparing many patients the morbidity of adjuvant treatment and reducing healthcare costs.
","[{'ForeName': 'Anne Sophie V M', 'Initials': 'ASVM', 'LastName': 'van den Heerik', 'Affiliation': 'Radiation Oncology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands a.v.m.van_den_heerik@lumc.nl.'}, {'ForeName': 'Nanda', 'Initials': 'N', 'LastName': 'Horeweg', 'Affiliation': 'Radiation Oncology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Remi A', 'Initials': 'RA', 'LastName': 'Nout', 'Affiliation': 'Radiation Oncology, Erasmus Medical Center - Cancer Institute, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Ludy C H W', 'Initials': 'LCHW', 'LastName': 'Lutgens', 'Affiliation': 'Radiation Oncology, Maastricht University Medical Centre+, Maastricht, Limburg, The Netherlands.'}, {'ForeName': 'Elzbieta M', 'Initials': 'EM', 'LastName': 'van der Steen-Banasik', 'Affiliation': 'Radation Oncology, Radiotherapy Group, Arnhem, Gelderland, The Netherlands.'}, {'ForeName': 'G Henrieke', 'Initials': 'GH', 'LastName': 'Westerveld', 'Affiliation': 'Radiation Oncology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Hetty A', 'Initials': 'HA', 'LastName': 'van den Berg', 'Affiliation': 'Radiation Oncology, Catharina Hospital, Eindhoven, Noord-Brabant, The Netherlands.'}, {'ForeName': 'Annerie', 'Initials': 'A', 'LastName': 'Slot', 'Affiliation': 'Radiation Oncology, Radiotherapy Institute Friesland, Leeuwarden, Friesland, The Netherlands.'}, {'ForeName': 'Friederike L A', 'Initials': 'FLA', 'LastName': 'Koppe', 'Affiliation': 'Radiation Oncology, Institute Verbeeten, Tilburg, Noord-Brabant, The Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kommoss', 'Affiliation': ""Women's Health, Universitätsklinikum Tübingen, Tübingen, Baden-Württemberg, Germany.""}, {'ForeName': 'Jan Willem M', 'Initials': 'JWM', 'LastName': 'Mens', 'Affiliation': 'Radiation Oncology, Erasmus Medical Center - Cancer Institute, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Marlies E', 'Initials': 'ME', 'LastName': 'Nowee', 'Affiliation': 'Radiation Oncology, Netherlands Cancer Institute, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bijmolt', 'Affiliation': 'Radiation Oncology, University Medical Centre Groningen, University of Groningen, Groningen, Groningen, The Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cibula', 'Affiliation': 'Gynecologic Oncology Centre, Department of Obstetrics and Gynaecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Tanja C', 'Initials': 'TC', 'LastName': 'Stam', 'Affiliation': 'Radiation Oncology, Haaglanden Medical Center, Den Haag, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Ina M', 'Initials': 'IM', 'LastName': 'Jurgenliemk-Schulz', 'Affiliation': 'Radiation Oncology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Snyers', 'Affiliation': 'Radiation Oncology, Radboudumc, Nijmegen, Gelderland, The Netherlands.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Hamann', 'Affiliation': ""Women's Health, Rotkreuzklinikum Munchen, Munchen, Bayern, Germany.""}, {'ForeName': 'Aleida G', 'Initials': 'AG', 'LastName': 'Zwanenburg', 'Affiliation': 'Radiation Oncology, Isala Klinieken, Zwolle, Overijssel, The Netherlands.'}, {'ForeName': 'Veronique L M A', 'Initials': 'VLMA', 'LastName': 'Coen', 'Affiliation': 'Radiation Oncology, Zuidwest Radiotherapeutic Institute, Vlissingen, Zeeland, The Netherlands.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'Vandecasteele', 'Affiliation': 'Radiation Oncology, University Hospital Ghent, Gent, Oost-Vlaanderen, Belgium.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Gillham', 'Affiliation': ""Radiation Oncology, St. Luke's Hospital Dublin, Dublin, Ireland.""}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Chargari', 'Affiliation': 'Radiation Oncology, Institut Gustave-Roussy, Villejuif, Île-de-France, France.'}, {'ForeName': 'Karen W', 'Initials': 'KW', 'LastName': 'Verhoeven-Adema', 'Affiliation': 'Comprehensive Cancer Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Medical Statistics, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Wilbert B', 'Initials': 'WB', 'LastName': 'van den Hout', 'Affiliation': 'Biomedical Data Sciences, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Bastiaan G', 'Initials': 'BG', 'LastName': 'Wortman', 'Affiliation': 'Radiation Oncology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Hans W', 'Initials': 'HW', 'LastName': 'Nijman', 'Affiliation': 'Obstetrics & Gynecology, University Medical Centre Groningen, University of Groningen, Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Tjalling', 'Initials': 'T', 'LastName': 'Bosse', 'Affiliation': 'Pathology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Carien L', 'Initials': 'CL', 'LastName': 'Creutzberg', 'Affiliation': 'Radiation Oncology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001929']
2472,33047042,Warning 'Don't spread' versus 'Don't be a spreader' to prevent the COVID-19 pandemic.,"The coronavirus disease 2019 (COVID-19) outbreak is threatening not only health but also life worldwide. It is important to encourage citizens to voluntarily practise infection-prevention (IP) behaviours such as social distancing and self-restraint. Previous research on social cognition suggested that emphasizing self-identity is key to changing a person's behaviour. The present study investigated whether reminders that highlight self-identity would be effective in changing intention and behaviour related to the COVID-19 outbreak, and hypothesized that those who read reminders highlighting self-identity (Don't be a spreader) would change IP intention and behaviour better than those who read 'Don't spread' or no reminder. We conducted a two-wave survey of the same participants with a one-week interval, during which we assigned one of three reminder conditions to the participants: 'Don't spread' (spreading condition), 'Don't be a spreader' (spreader condition) and no reminder (control condition). Participants marked their responses to IP intentions and actual behaviours each week based on the Japanese Ministry of Health, Labour and Welfare guidelines. While the results did not show significant differences between the conditions, the  post hoc  analyses showed significant equivalence in either IP intentions or behavioural scores. We discussed the results from the perspective of the effect size, ceiling effects and ways of manipulation checks as future methods with more effective persuasive messaging. Following in-principle acceptance, the approved Stage 1 version of this manuscript was pre-registered on the OSF at https://doi.org/10.17605/OSF.IO/KZ5Y4. This pre-registration was performed prior to data collection and analysis.",2020,"While the results did not show significant differences between the conditions, the  post hoc  analyses showed significant equivalence in either IP intentions or behavioural scores.","['same participants with a one-week interval, during which we assigned one of three reminder conditions to the participants']","[""Don't spread' (spreading condition), 'Don't be a spreader' (spreader condition) and no reminder (control condition""]",['behavioural scores'],"[{'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0183479', 'cui_str': 'Spreader'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0402079,"While the results did not show significant differences between the conditions, the  post hoc  analyses showed significant equivalence in either IP intentions or behavioural scores.","[{'ForeName': 'Fumiya', 'Initials': 'F', 'LastName': 'Yonemitsu', 'Affiliation': 'Graduate School of Human-Environment Studies, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Ikeda', 'Affiliation': 'Graduate School of Human-Environment Studies, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Yoshimura', 'Affiliation': 'Graduate School of Human-Environment Studies, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Kaito', 'Initials': 'K', 'LastName': 'Takashima', 'Affiliation': 'Graduate School of Human-Environment Studies, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Mori', 'Affiliation': 'Graduate School of Human-Environment Studies, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Kyoshiro', 'Initials': 'K', 'LastName': 'Sasaki', 'Affiliation': 'Faculty of Informatics, Kansai University, Osaka, Japan.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Qian', 'Affiliation': 'Institute of Decision Science for a Sustainable Society, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Faculty of Arts and Science, Kyushu University, Fukuoka, Japan.'}]",Royal Society open science,['10.1098/rsos.200793']
2473,33047127,"Harsh and sweet sensations predict acute liking of electronic cigarettes, but flavor does not affect acute nicotine intake: a pilot laboratory study in men.","INTRODUCTION


Electronic cigarette (eCig) use is increasing in popularity, and thousands of flavors are available. Adolescent vaping rates in the United States have nearly doubled in the past year. Unlike combustible tobacco, added flavors are not currently regulated for electronic cigarette products. Here, we investigated the role of flavor in eCig liking and acute intake.
METHODS


Men (n=39) aged 18-45 vaped in a controlled laboratory setting after being randomized to one of four e-liquids: 6mg nicotine/ml Cherry, 18mg/ml Cherry, 6mg/ml Chocolate, or 18mg/ml Chocolate. They completed several questionnaires, and vaped ad libitum for 10 minutes. After the first puff, participants rated sensations (sweetness, bitterness, coolness, harshness/irritation) on general labeled magnitude scales (gLMS) and rated overall liking on a generalized hedonic scale. Once the 10-minute session ended, participants made another set of ratings.
RESULTS


Liking was generally stable across the vaping session and liking varied substantially across the 4 conditions. Across all conditions, sensory ratings predicted liking: harshness/irritation was negatively associated with first puff liking while perceived sweetness was positively associated with first puff liking. First puff liking associated with increased amount of e-liquid vaped, but not total nicotine intake. Participants appeared to titrate their nicotine intake regardless of assigned condition.
CONCLUSION


Flavored eLiquids affect acute rated liking, but not acute nicotine intake.
IMPLICATIONS


These data suggest individuals who regularly vape may titrate their nicotine intake, regardless of flavor, and contrary to expectations, acute liking did not predict total intake. However, more-liked flavors may potentially make higher nicotine levels more tolerable by adding pleasant sensations directly, rather than by perceptual masking that reduce aversive sensations.",2020,"Across all conditions, sensory ratings predicted liking: harshness/irritation was negatively associated with first puff liking while perceived sweetness was positively associated with first puff liking.","['men', 'Men (n=39) aged 18-45 vaped in a controlled laboratory setting after being randomized to one of four e-liquids: 6mg']","['nicotine/ml Cherry, 18mg', 'ml Chocolate']","['Adolescent vaping rates', 'acute nicotine intake', 'aversive sensations', 'rated sensations (sweetness, bitterness, coolness, harshness/irritation) on general labeled magnitude scales (gLMS) and rated overall liking on a generalized hedonic scale']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0330657', 'cui_str': 'Prunus cerasus'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0234804', 'cui_str': 'Harsh voice quality'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0726671,"Across all conditions, sensory ratings predicted liking: harshness/irritation was negatively associated with first puff liking while perceived sweetness was positively associated with first puff liking.","[{'ForeName': 'Allison N', 'Initials': 'AN', 'LastName': 'Baker', 'Affiliation': 'Graduate Program in Neuroscience, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Alyssa J', 'Initials': 'AJ', 'LastName': 'Bakke', 'Affiliation': 'Sensory Evaluation Center, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Branstetter', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Hayes', 'Affiliation': 'Graduate Program in Neuroscience, The Pennsylvania State University, University Park, PA, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa209']
2474,33047176,Pronator quadratus repair after volar plate fixation in distal radial fractures: evaluation of the clinical and functional outcome and of the protective role on the flexor tendons-a randomized controlled study.,"The objective was to evaluate pronator quadratus (PQ) repair following volar plating of distal radial fractures on clinical and functional outcome, as well as flexor tendon friction, during the first 12 months in ideally positioned plates (Soong 0). Confounding factors like variation in plate positioning, anatomical consolidation of the fracture and associated lesions were excluded. Eighty patients were included with distal radius fractures treated by volar locking plate in Soong grade 0 position, who were randomized to group PQ repair and group no repair. Sixty-five patients completed the 1-year follow-up: group PQ repair (n = 35) and group no repair (n = 30). Primary outcomes included range of motion, grip strength, pain level and QuickDASH. Secondary outcomes included distance between flexor pollicis longus (FPL) and volar rim and the largest distance between FPL and plate (soft tissue thickness occupied by PQ), assessed by ultrasonography. Mobility, grip strength and QuickDASH revealed no significant differences, except extension was significantly higher only in first 3 months and radial deviation was significantly higher only at 6 weeks after PQ repair. Pain level was significantly lower after PQ repair only in the first 3 months. Distance between FPL and volar rim and the largest distance between FPL and plate were significantly higher after PQ repair. No friction contact between FPL and volar rim was measured in both groups at all measurement moments. Consequently, protective flexor tendon effect of PQ repair could consequently not be concluded. In conclusion, clinical and functional short term benefits, except improved wrist extension and reduced pain in the first 3 months, were not proven in this study. In Soong grade 0, PQ repair is probably not necessary to prevent flexor tendon pathology. In Soong grade 1 or 2, this is still to be investigated. LEVEL OF EVIDENCE: 2.",2020,"Mobility, grip strength and QuickDASH revealed no significant differences, except extension was significantly higher only in first 3 months and radial deviation was significantly higher only at 6 weeks after PQ repair.","['distal radial fractures', 'Eighty patients were included with distal radius fractures treated by', 'Sixty-five patients completed the 1-year follow-up: group PQ repair (n\u2009=\u200935) and group no repair (n\u2009=\u200930']","['PQ repair and group no repair', 'pronator quadratus (PQ) repair following volar plating of distal radial fractures', 'Pronator quadratus repair after volar plate fixation', 'volar locking plate']","['range of motion, grip strength, pain level and QuickDASH', 'Mobility, grip strength and QuickDASH', 'friction contact between FPL and volar rim', 'Pain level', 'radial deviation', 'wrist extension and reduced pain', 'distance between flexor pollicis longus (FPL) and volar rim and the largest distance between FPL and plate (soft tissue thickness occupied by PQ), assessed by ultrasonography']","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0224263', 'cui_str': 'Structure of pronator quadratus muscle'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0224263', 'cui_str': 'Structure of pronator quadratus muscle'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0162691', 'cui_str': 'Friction'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0224262', 'cui_str': 'Flexor pollicis longus muscle structure'}, {'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0556630', 'cui_str': 'Anal penetration using tongue'}, {'cui': 'C0449751', 'cui_str': 'Radial deviation'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0224263', 'cui_str': 'Structure of pronator quadratus muscle'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",80.0,0.0629832,"Mobility, grip strength and QuickDASH revealed no significant differences, except extension was significantly higher only in first 3 months and radial deviation was significantly higher only at 6 weeks after PQ repair.","[{'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Goorens', 'Affiliation': 'Regionaal Ziekenhuis Tienen, Kliniekstraat 45, 3300, Tienen, Belgium. cgoorens@msn.com.'}, {'ForeName': 'P B', 'Initials': 'PB', 'LastName': 'De Keyzer', 'Affiliation': 'Regionaal Ziekenhuis Tienen, Kliniekstraat 45, 3300, Tienen, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Van Royen', 'Affiliation': 'University Hospital Brussels, Vrije Universiteit Brussel, Laarbeeklaan 101, 1090, Brussels, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Provyn', 'Affiliation': 'Vrije Universiteit Brussel, Laarbeeklaan 101, 1090, Brussels, Belgium.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Goubau', 'Affiliation': 'University Hospital Brussels, Vrije Universiteit Brussel, Laarbeeklaan 101, 1090, Brussels, Belgium.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-020-02804-1']
2475,33047203,Effect of restorative timing on shear bond strength of composite resin/calcium silicate-based cements adhesive interfaces.,"OBJECTIVES


The aim of this study was to evaluate the shear bond strength inherent to immediate and delayed definitive composite resin restorations, over three different biomaterials.
METHODS


Fifty-four aluminum blocks were randomly assigned to six experimental groups (n = 9) according to the biomaterial (Biodentine, TotalFill BC Putty, or PCM) and restoration timing (immediate or 7 days delayed). Regarding the restorative procedures, a two-step self-etch bonding system (Clearfil SE Bond) was applied and subsequently restored using a flowable composite resin (SDR). After shear bond strength testing, fracture pattern analysis was performed. The significance level was set at α = 0.05.
RESULTS


Within the immediate groups, Biodentine showed the highest mean shear bond strength value, with no statistically significant differences (P > 0.05) being detected when compared with both TotalFill (P = 0.072) and PCM (P = 0.232) groups. Regarding the delayed restoration groups, Biodentine and TotalFill presented the highest mean shear bond strength value, with statistical differences when compared with PCM (P = 0.002 and P = 0.043, respectively). No statistically significant differences (P > 0.05) were verified between both immediate and delayed groups for each tested biomaterial. Also, a statistically significant association was found between the fracture type and the biomaterial (P < 0.001).
CONCLUSIONS AND CLINICAL RELEVANCE


Our findings suggest that all tested biomaterials present suitable alternatives which allow to perform restorative procedures immediately after pulp capping biomaterial placement (3 or 12 min, depending on the bioactive cement), therefore requiring one single appointment to complete the procedure. Biodentine and TotalFill BC Putty have shown superior shear bond strength results when compared with PCM, within a delayed timeframe (7 days).",2020,"Regarding the delayed restoration groups, Biodentine and TotalFill presented the highest mean shear bond strength value, with statistical differences when compared with PCM (P = 0.002 and P = 0.043, respectively).",['Fifty-four aluminum blocks'],"['biomaterial (Biodentine, TotalFill BC Putty, or PCM) and restoration timing (immediate or 7 days delayed', 'Biodentine and TotalFill BC Putty']","['highest mean shear bond strength value', 'shear bond strength']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0005479', 'cui_str': 'Biomaterials'}, {'cui': 'C3502756', 'cui_str': 'biodentine'}, {'cui': 'C0033677', 'cui_str': 'Deficiency of macronutrients'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",54.0,0.022012,"Regarding the delayed restoration groups, Biodentine and TotalFill presented the highest mean shear bond strength value, with statistical differences when compared with PCM (P = 0.002 and P = 0.043, respectively).","[{'ForeName': 'Paulo J', 'Initials': 'PJ', 'LastName': 'Palma', 'Affiliation': 'Institute of Endodontics, Faculty of Medicine, University of Coimbra, 3000-075, Coimbra, Portugal. ppalma@uc.pt.'}, {'ForeName': 'Joana A', 'Initials': 'JA', 'LastName': 'Marques', 'Affiliation': 'Institute of Endodontics, Faculty of Medicine, University of Coimbra, 3000-075, Coimbra, Portugal.'}, {'ForeName': 'Márcia', 'Initials': 'M', 'LastName': 'Antunes', 'Affiliation': 'Dentistry Department, Faculty of Medicine, University of Coimbra, 3000-075, Coimbra, Portugal.'}, {'ForeName': 'Rui I', 'Initials': 'RI', 'LastName': 'Falacho', 'Affiliation': 'Institute of Oral Implantology and Prosthodontics, Faculty of Medicine, University of Coimbra, 3000-075, Coimbra, Portugal.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Sequeira', 'Affiliation': 'Institute of Endodontics, Faculty of Medicine, University of Coimbra, 3000-075, Coimbra, Portugal.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Roseiro', 'Affiliation': 'Department of Mechanical Engineering, Institute of Engineering of Coimbra, Polytechnic - ISEC, 3000, Coimbra, Portugal.'}, {'ForeName': 'João Miguel', 'Initials': 'JM', 'LastName': 'Santos', 'Affiliation': 'Institute of Endodontics, Faculty of Medicine, University of Coimbra, 3000-075, Coimbra, Portugal.'}, {'ForeName': 'João C', 'Initials': 'JC', 'LastName': 'Ramos', 'Affiliation': 'Center for Innovation and Research in Oral Sciences (CIROS), Faculty of Medicine, University of Coimbra, Coimbra, Portugal.'}]",Clinical oral investigations,['10.1007/s00784-020-03640-7']
2476,33047216,"Pharmacokinetic and Pharmacodynamic Properties of Cemdisiran, an RNAi Therapeutic Targeting Complement Component 5, in Healthy Subjects and Patients with Paroxysmal Nocturnal Hemoglobinuria.","BACKGROUND


Cemdisiran, an N-acetylgalactosamine (GalNAc) conjugated RNA interference (RNAi) therapeutic, is currently under development for the treatment of complement-mediated diseases by suppressing liver production of complement 5 (C5) protein. This study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cemdisiran in healthy subjects and in patients with paroxysmal nocturnal hemoglobinuria (PNH) in order to support dose selection for late-stage clinical trials.
METHODS


Healthy volunteers (HVs; n = 32, including 12 Japanese subjects) were randomized (3:1) to receive single doses of subcutaneous cemdisiran (50-900 mg) or placebo, or repeat doses of subcutaneous cemdisiran (100-600 mg) or placebo weekly, biweekly, weekly/biweekly, or weekly/monthly for 5, 8, or 13 weeks (n = 24). Cemdisiran 200 or 400 mg was administered weekly in an open-label manner, for varying durations, as monotherapy in three eculizumab-naïve PNH patients or in combination with eculizumab in three PNH patients who were receiving stable label doses of eculizumab (900 or 1200 mg biweekly) before the start of the study. After the last dose of cemdisiran, patients were followed for safety and ongoing pharmacologic effects with the eculizumab regimen (600 or 900 mg every month).
RESULTS


In HVs, cemdisiran was rapidly converted to a major active metabolite, AS(N-2)3'-cemdisiran, both declining below the lower limit of quantification (LLOQ) in plasma within 48 h, and showing minimal renal excretion. AS(N-2)3'-cemdisiran exhibited more than dose-proportional PK. The C5 protein reductions were dose-dependent, with > 90% reduction of C5 protein beginning on days 21-28 and maintained for 10-13 months following single and biweekly doses of 600 mg. The dose-response relationship, described by an inhibitory sigmoid maximum effect (E max ) model, estimated half-maximal effective dose (ED 50 ) of 14.0 mg and maximum C5 reduction of 99% at 600 mg. The PK and PD were similar between Japanese and non-Japanese subjects, and PNH patients and HVs. One of 48 subjects tested transiently positive for antidrug antibody with low titer, with no impact on PK or PD. In PNH patients, C5 suppression by cemdisiran enabled effective inhibition of residual C5 levels with lower dose and/or dosing frequency of eculizumab, which was maintained for 6-10 months after the last dose of cemdisiran.
CONCLUSIONS


Consistent with the PK/PD properties of liver targeting GalNac conjugates, cemdisiran and AS(N-2)3'-cemdisiran plasma concentrations declined rapidly while showing rapid and robust C5 suppression maintained up to 13 months following single and multiple doses, which indicates long residence times of cemdisiran within hepatocytes. The long PD duration of action in liver, low immunogenicity and acceptable safety profiles enables low, infrequent SC dosing and support further evaluation of cemdisiran in complement-mediated diseases as monotherapy or in combination with a C5 inhibitor antibody.
CLINICAL TRIAL REGISTRATION NO


NCT02352493.",2020,"The C5 protein reductions were dose-dependent, with > 90% reduction of C5 protein beginning on days 21-28 and maintained for 10-13 months following single and biweekly doses of 600 mg.","['healthy subjects and in patients with paroxysmal nocturnal hemoglobinuria (PNH', 'Healthy Subjects and Patients with Paroxysmal Nocturnal Hemoglobinuria', 'Healthy volunteers (HVs; n\u2009=\u200932, including 12 Japanese subjects']","['subcutaneous cemdisiran', 'eculizumab-naïve PNH patients or in combination with eculizumab in three PNH patients who were receiving stable label doses of eculizumab', 'placebo, or repeat doses of subcutaneous cemdisiran (100-600\xa0mg) or placebo', 'eculizumab regimen', 'acetylgalactosamine (GalNAc) conjugated RNA interference (RNAi) therapeutic']","['C5 protein reductions', 'safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cemdisiran', ""cemdisiran and AS(N-2)3'-cemdisiran plasma concentrations"", 'residual C5 levels']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024790', 'cui_str': 'Paroxysmal nocturnal hemoglobinuria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C0024790', 'cui_str': 'Paroxysmal nocturnal hemoglobinuria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0001055', 'cui_str': '2-Acetamido-2-D-galactopyranose'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C1136031', 'cui_str': 'Post-Transcriptional Gene Silencing'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0009519', 'cui_str': 'Complement component C5'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",12.0,0.0423508,"The C5 protein reductions were dose-dependent, with > 90% reduction of C5 protein beginning on days 21-28 and maintained for 10-13 months following single and biweekly doses of 600 mg.","[{'ForeName': 'Prajakta', 'Initials': 'P', 'LastName': 'Badri', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, Alnylam Pharmaceuticals, 101 Main Street, Cambridge, MA, 02142, USA. pbadri@alnylam.com.'}, {'ForeName': 'Xuemin', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Borodovsky', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, Alnylam Pharmaceuticals, 101 Main Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Najafian', 'Affiliation': 'Alexion Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Jae', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, Alnylam Pharmaceuticals, 101 Main Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Clausen', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, Alnylam Pharmaceuticals, 101 Main Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Goel', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, Alnylam Pharmaceuticals, 101 Main Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Bahru', 'Initials': 'B', 'LastName': 'Habtemariam', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, Alnylam Pharmaceuticals, 101 Main Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Gabriel J', 'Initials': 'GJ', 'LastName': 'Robbie', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, Alnylam Pharmaceuticals, 101 Main Street, Cambridge, MA, 02142, USA.'}]",Clinical pharmacokinetics,['10.1007/s40262-020-00940-9']
2477,33047252,Use and Deprescribing of Potentially Inappropriate Medications in Frail Nursing Home Residents.,"BACKGROUND


The STOPPFrail criteria were developed to assist physicians in deprescribing medications among frail patients approaching end of life. We aimed to measure the prevalence of potentially inappropriate medications (PIMs) and to describe changes over time, using STOPPFrail, in frail nursing home residents (NHRs) with limited life expectancy included in a medication review trial.
METHODS


We conducted a post-hoc analysis of the COME-ON study, a cluster-controlled trial that evaluated the effect of a complex intervention on appropriateness of prescribing in Belgian nursing homes. We identified NHRs eligible for the application of STOPPFrail based on functional status, comorbidities, level of care and survival. PIM use was measured at baseline and at 8 months. Changes over time were compared in the control group (CG) and intervention group (IG).
RESULTS


At baseline, 308 NHRs met the STOPPFrail eligibility criteria, of whom 196 (64.1%) had one or more PIM. At 8 months, among the 218 NHRs who were alive, there was an absolute reduction in the prevalence of PIMs of 9.1% in the CG (p < 0.05) and 10.2% in the IG (p < 0.05). We found large reductions for some medications (e.g. proton pump inhibitors) but no reduction for others (e.g. calcium). The percentage of NHRs with one or more PIM discontinued without a new PIM initiated was higher in the IG than the CG but the difference was not significant (35.1% vs 23.6%, p = 0.127).
CONCLUSION


Among frail NHRs with poor survival prognosis, a significant and encouraging decrease in PIM prevalence over time was observed, probably facilitated by medication reviews. The overall prevalence of PIMs remained high, however.",2020,"At 8 months, among the 218 NHRs who were alive, there was an absolute reduction in the prevalence of PIMs of 9.1% in the CG (p < 0.05) and 10.2% in the IG (p < 0.05).","['frail nursing home residents (NHRs) with limited life expectancy included in a medication review trial', 'Belgian nursing homes', 'Frail Nursing Home Residents']",['complex intervention'],"['prevalence of PIMs', 'PIM use', 'PIM prevalence', 'percentage of NHRs']","[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0337797', 'cui_str': 'Belgians'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]",,0.0414043,"At 8 months, among the 218 NHRs who were alive, there was an absolute reduction in the prevalence of PIMs of 9.1% in the CG (p < 0.05) and 10.2% in the IG (p < 0.05).","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Fournier', 'Affiliation': 'Louvain Drug Research Institute, Clinical Pharmacy Research Group, Université Catholique de Louvain, Avenue Mounier 72/B1.72.02, 1200 Woluwe-Saint-Lambert, Brussels, Belgium.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Anrys', 'Affiliation': 'Louvain Drug Research Institute, Clinical Pharmacy Research Group, Université Catholique de Louvain, Avenue Mounier 72/B1.72.02, 1200 Woluwe-Saint-Lambert, Brussels, Belgium.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Beuscart', 'Affiliation': 'Univ. Lille, CHU Lille, ULR 2694 - METRICS : Évaluation des technologies de santé et des pratiques médicales, 59000, Lille, France.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Dalleur', 'Affiliation': 'Louvain Drug Research Institute, Clinical Pharmacy Research Group, Université Catholique de Louvain, Avenue Mounier 72/B1.72.02, 1200 Woluwe-Saint-Lambert, Brussels, Belgium.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Henrard', 'Affiliation': 'Louvain Drug Research Institute, Clinical Pharmacy Research Group, Université Catholique de Louvain, Avenue Mounier 72/B1.72.02, 1200 Woluwe-Saint-Lambert, Brussels, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Foulon', 'Affiliation': 'Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Spinewine', 'Affiliation': 'Louvain Drug Research Institute, Clinical Pharmacy Research Group, Université Catholique de Louvain, Avenue Mounier 72/B1.72.02, 1200 Woluwe-Saint-Lambert, Brussels, Belgium. anne.spinewine@uclouvain.be.'}]",Drugs & aging,['10.1007/s40266-020-00805-7']
2478,33047257,Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension and diabetes mellitus: results from the PREVER-treatment randomized controlled trial.,"AIMS


To compare the blood pressure (BP)-lowering efficacy of a chlorthalidone/amiloride combination pill with losartan, during initial management of JNC 7 Stage I hypertension in patients with type 2 diabetes mellitus.
METHODS


In an a priori subgroup analysis of a randomized, double-blind, controlled trial, volunteers aged 30-70 years, with stage I hypertension and diabetes mellitus, were randomized to 12.5/2.5 mg of chlorthalidone/amiloride (N = 47) or 50 mg of losartan (N = 50), and followed for 18 months in 21 clinical centers. If BP remained uncontrolled after three months, study medication dose was doubled, and if uncontrolled after six months, amlodipine (5 and 10 mg) and propranolol (40 and 80 mg BID) were added as open label drugs in a progressive fashion.
RESULTS


Systolic BP decreased to a greater extent in participants allocated to diuretics compared to losartan (P < 0.001). After 18 months of follow-up, systolic BP was 128.4 ± 10.3 mmHg in the diuretic group versus 133.5 ± 8.0 in the losartan group (P < 0.01). In the diuretic group, 36 out of 43 participants (83.7%) had a JNC 7 normal BP, compared to 31/47 (66%) in the losartan group (P = 0.089). Serum cholesterol was higher in the diuretic arm at the end of the trial. Other biochemical parameters and reports of adverse events did not differ by treatment.
CONCLUSIONS


Treatment of hypertension based on a combination of chlorthalidone and amiloride is more effective for BP lowering compared to losartan in patients with diabetes mellitus and hypertension.
TRIAL REGISTRATION


Clinical trials registration number: NCT00971165.",2020,"RESULTS


Systolic BP decreased to a greater extent in participants allocated to diuretics compared to losartan (P < 0.001).","['patients with type 2 diabetes mellitus', 'patients with stage I hypertension and diabetes mellitus', 'volunteers aged 30-70\xa0years, with stage', 'I hypertension and diabetes mellitus', 'patients with diabetes mellitus and hypertension']","['losartan', 'propranolol', 'chlorthalidone and amiloride', 'amlodipine', 'chlorthalidone/amiloride (N\u2009=\u200947) or 50\xa0mg of losartan', 'chlorthalidone/amiloride versus losartan', 'chlorthalidone/amiloride combination pill with losartan']","['systolic BP', 'Systolic BP', 'blood pressure', 'Serum cholesterol', 'adverse events', 'JNC 7 normal BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}, {'cui': 'C0002502', 'cui_str': 'Amiloride'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}]",43.0,0.189848,"RESULTS


Systolic BP decreased to a greater extent in participants allocated to diuretics compared to losartan (P < 0.001).","[{'ForeName': 'Flávio D', 'Initials': 'FD', 'LastName': 'Fuchs', 'Affiliation': 'Division of Cardiology, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande Do Sul, INCT PREVER, CPC, 5º. and Ramiro Barcelos, 2350, Porto Alegre, RS, 90035-903, Brazil.'}, {'ForeName': 'Luiz C N', 'Initials': 'LCN', 'LastName': 'Scala', 'Affiliation': 'Hospital Universitário Júlio Müller, Universidade Federal de Mato Grosso, Cuiabá, MT, Brazil.'}, {'ForeName': 'José F', 'Initials': 'JF', 'LastName': 'Vilela-Martin', 'Affiliation': 'Faculdade de Medicina São José Do Rio Preto, São José do Rio Preto, SP, Brazil.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, USA.'}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Poli-de-Figueiredo', 'Affiliation': 'Faculdade de Medicina Hospital São Lucas, PUCRS, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Pereira E Silva', 'Affiliation': 'Hospital Universitário Walter Cantídio, Universidade Federal do Ceará, Fortaleza, CE, Brazil.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Gus', 'Affiliation': 'Division of Cardiology, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande Do Sul, INCT PREVER, CPC, 5º. and Ramiro Barcelos, 2350, Porto Alegre, RS, 90035-903, Brazil.'}, {'ForeName': 'Luiz A', 'Initials': 'LA', 'LastName': 'Bortolotto', 'Affiliation': 'Faculdade de Medicina, Instituto do Coração, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Fernanda M', 'Initials': 'FM', 'LastName': 'Consolim-Colombo', 'Affiliation': 'Faculdade de Medicina, Instituto do Coração, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Rosane P', 'Initials': 'RP', 'LastName': 'Schlatter', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande Do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'José E', 'Initials': 'JE', 'LastName': 'Cesarino', 'Affiliation': 'Faculdade de Ciências Farmacêuticas, USP Ribeirão Preto, Ribeirão Prêto, SP, Brazil.'}, {'ForeName': 'Iran', 'Initials': 'I', 'LastName': 'Castro', 'Affiliation': 'Instituto de Cardiologia, Av. Princesa Isabel, Porto Alegre, RS, 395, Brazil.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Figueiredo Neto', 'Affiliation': 'Hospital Universitário Universidade Federal do Maranhão, São Luís, MA, Brazil.'}, {'ForeName': 'Hilton', 'Initials': 'H', 'LastName': 'Chaves', 'Affiliation': 'Universidade Federal de Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'André A', 'Initials': 'AA', 'LastName': 'Steffens', 'Affiliation': 'Universidade Federal de Pelotas, Pelotas, RS, 96010-610, Brazil.'}, {'ForeName': 'João G', 'Initials': 'JG', 'LastName': 'Alves', 'Affiliation': 'Instituto de Medicina Integral Prof Fernando Figueira, Recife, PE, Brazil.'}, {'ForeName': 'Andréa A', 'Initials': 'AA', 'LastName': 'Brandão', 'Affiliation': 'Universidade Do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Marcos R', 'Initials': 'MR', 'LastName': 'de Sousa', 'Affiliation': 'Hospital das Clínicas da Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Paulo C', 'Initials': 'PC', 'LastName': 'Jardim', 'Affiliation': 'Hospital das Clínicas de Goiânia, Universidade Federal de Goiás, Goiânia, GO, Brazil.'}, {'ForeName': 'Leila B', 'Initials': 'LB', 'LastName': 'Moreira', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande Do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Roberto S', 'Initials': 'RS', 'LastName': 'Franco', 'Affiliation': 'Faculdade de Medicina de Botucatu, Botucatu, SP, Brazil.'}, {'ForeName': 'Marco M', 'Initials': 'MM', 'LastName': 'Gomes', 'Affiliation': 'Hospital do Coração de Alagoas, Maceió, AL, Brazil.'}, {'ForeName': 'Abrahão', 'Initials': 'A', 'LastName': 'Afiune Neto', 'Affiliation': 'Anis Rassi Hospital, Goiânia, GO, Brazil.'}, {'ForeName': 'Felipe C', 'Initials': 'FC', 'LastName': 'Fuchs', 'Affiliation': 'Division of Cardiology, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande Do Sul, INCT PREVER, CPC, 5º. and Ramiro Barcelos, 2350, Porto Alegre, RS, 90035-903, Brazil.'}, {'ForeName': 'Dario C', 'Initials': 'DC', 'LastName': 'Sobral Filho', 'Affiliation': 'Hospital Universitário Procape, Recife, PE, Brazil.'}, {'ForeName': 'Antônio C', 'Initials': 'AC', 'LastName': 'Nóbrega', 'Affiliation': 'Hospital Universitário Antônio Pedro, UFF, Niterói, RJ, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Nobre', 'Affiliation': 'Faculdade de Medicina de Ribeirão Preto, USP Ribeirão Preto, Ribeirão Prêto, SP, Brazil.'}, {'ForeName': 'Otávio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Instituto de Pesquisa, Hospital Israelita Albert Einstein, São Paulo, SP, Brazil.'}, {'ForeName': 'Sandra C', 'Initials': 'SC', 'LastName': 'Fuchs', 'Affiliation': 'Division of Cardiology, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande Do Sul, INCT PREVER, CPC, 5º. and Ramiro Barcelos, 2350, Porto Alegre, RS, 90035-903, Brazil. sfuchs@hcpa.edu.br.'}]",Acta diabetologica,['10.1007/s00592-020-01611-8']
2479,33047258,A Randomized Trial Comparing Brief Advice and Motivational Interviewing for Persons with HIV-HCV Co-infection Who Drink Alcohol.,"Alcohol use contributes to the progression of liver disease in HIV-HCV co-infected persons, but alcohol interventions have never addressed low levels of alcohol use in this population. We enrolled 110 persons consuming at least 4 alcoholic drinks weekly in a clinical trial comparing two active 18-month long interventions, delivered every 3 months by phone, brief advice about drinking versus a motivational intervention. Final assessment was at 24 months. MI had larger reductions in alcohol use days than the BA arm at all follow-up assessments. The treatment by time effect was not significant for days of drinking (p = 0.470), mean drinks per day (p = 0.155), or for the continuous FIB-4 index (p = 0.175). Drinking declined in both conditions from baseline, but given the small sample, we do not have sufficient data to make any conclusion that one treatment is superior to the other.Trial Registry Trial registered at clinicaltrials.gov; Clinical Trial NCT02316184.",2020,"The treatment by time effect was not significant for days of drinking (p = 0.470), mean drinks per day (p = 0.155), or for the continuous FIB-4 index (p = 0.175).","['Persons with HIV-HCV Co-infection Who Drink Alcohol', '110 persons consuming at least 4 alcoholic drinks weekly in a clinical trial comparing two']","['Advice and Motivational Interviewing', 'active 18-month long interventions, delivered every 3\xa0months by phone, brief advice about drinking versus a motivational intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]",[],110.0,0.0422293,"The treatment by time effect was not significant for days of drinking (p = 0.470), mean drinks per day (p = 0.155), or for the continuous FIB-4 index (p = 0.175).","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Stein', 'Affiliation': 'Behavioral Medicine and Addictions Research, Butler Hospital, Providence, RI, USA. mdstein@bu.edu.'}, {'ForeName': 'Debra S', 'Initials': 'DS', 'LastName': 'Herman', 'Affiliation': 'Behavioral Medicine and Addictions Research, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'H Nina', 'Initials': 'HN', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Howell', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Lambert', 'Affiliation': 'Department of Health Law, Policy & Management, Boston University School of Public Health, 715 Albany Street, Boston, MA, 02118, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Madden', 'Affiliation': 'The Miriam Hospital, Providence, RI, USA.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Moitra', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Blevins', 'Affiliation': 'Behavioral Medicine and Addictions Research, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': 'Behavioral Medicine and Addictions Research, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Taylor', 'Affiliation': 'University of Rhode Island, Providence, RI, USA.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Pinkston', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]",AIDS and behavior,['10.1007/s10461-020-03062-2']
2480,33050459,May Mangafodipir or Other SOD Mimetics Contribute to Better Care in COVID-19 Patients?,"Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is characterized by massive inflammation of the arterial endothelium accompanied by vasoconstriction and widespread pulmonary micro thrombi. As a result, due to the destruction of nitric oxide ( • NO) by inflammatory superoxide (O 2 •- ), pulmonary  • NO concentration ceases, resulting in uncontrolled platelet aggregation and massive thrombosis, which kills the patients. Introducing  • NO by inhalation (INO) may replace the loss of endothelium-derived  • NO. The first results from clinical trials with INO in SARS-CoV-2 patients show a rapid and sustained improvement in cardiopulmonary function and decreased inflammation. An ongoing phase III study is expected to confirm the method's efficacy. INO may hence become a first line treatment in SARS-CoV-2 patients. However, due to the rapid inactivation of  • NO by deoxyhemoglobin to nitrate, pulmonary administration of  • NO will not protect remote organs. Another INO-related pharmacological approach to protect SARS-CoV-2 patients from developing life-threatening disease is to inhibit the O 2 •- -driven destruction of  • NO by neutralizing inflammatory O 2 •- . By making use of low molecular weight compounds that mimic the action of the enzyme manganese superoxide dismutase (MnSOD). The MnSOD mimetics of the so-called porphyrin type (e.g., AEOL 10150), salen type (e.g., EUK-8) and cyclic polyamine type (e.g., M40419, today known as GC4419 and avasopasem manganese) have all been shown to positively affect the inflammatory response in lung epithelial cells in preclinical models of chronic obstructive pulmonary disease. The Manganese diPyridoxyL EthylDiamine (MnPLED)-type mangafodipir (manganese dipyridoxyl diphosphate-MnDPDP), a magnetic resonance imaging (MRI) contrast agent that possesses MnSOD mimetic activity, has shown promising results in various forms of inflammation, in preclinical as well as clinical settings. Intravenously administration of mangafodipir will, in contrast to INO, reach remote organs and may hence become an important supplement to INO. From the authors' viewpoint, it appears logical to test mangafodipr in COVID-19 patients at risk of developing life-threatening SARS-CoV-2. Five days after submission of the current manuscript, Galera Pharmaceuticals Inc. announced the dosing of the first patient in a randomized, double-blind pilot phase II clinical trial with GC4419 for COVID-19. The study was first posted on ClinicalTrials.gov (Identifier: NCT04555096) 18 September 2020.",2020,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is characterized by massive inflammation of the arterial endothelium accompanied by vasoconstriction and widespread pulmonary micro thrombi.,['SARS-CoV-2 patients'],"['mangafodipir', 'magnetic resonance imaging (MRI']",['cardiopulmonary function and decreased inflammation'],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0772321', 'cui_str': 'MANGAFODIPIR'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.0324482,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is characterized by massive inflammation of the arterial endothelium accompanied by vasoconstriction and widespread pulmonary micro thrombi.,"[{'ForeName': 'Jan Olof G', 'Initials': 'JOG', 'LastName': 'Karlsson', 'Affiliation': 'Division of Drug Research/Pharmacology, Linköping University, SE-581 83 Linköping, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Jynge', 'Affiliation': 'Innlandet Trust Hospital, Gjøvik Hospital, NO-2819 Gjøvik, Norway.'}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Ignarro', 'Affiliation': 'Department of Pharmacology, UCLA School of Medicine, 264 El Camino Drive, Beverly Hills, CA 90212, USA.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9100971']
2481,33050586,"The Effect of Fermented Porcine Placental Extract on Fatigue-Related Parameters in Healthy Adults: A Double-Blind, Randomized, Placebo-Controlled Trial.","BACKGROUND


Fatigue is one of the major health conditions induced by excessive stress or abnormal immune function or defective antioxidant systems. Placental extract has been reported to have various effects such as immune modulation and cellular regeneration. Fermented porcine placenta (FPP) is a safe nontoxic material, which is highly valuable as a functional food. The aim of this study was to investigate the anti-fatigue effects of FPP supplementation compared with a placebo product.
METHODS


In this double-blind, parallel, randomized, and placebo-controlled trial 84 healthy males and females, aged between 30 and 60 years were randomized to 320 mg of FPP once daily or placebo. The main outcome measures included efficacy of fatigue-inducing treadmill exercise on physical fatigue and fatigue-related parameters based on the questionnaire administered.
RESULTS


The IL-1β mRNA expression and fatigue severity scale were changed significantly after 8 weeks of treatment with fermented porcine placenta compared with placebo ( p  < 0.05). Cortisol levels were significantly improved in participants younger than 45 years following treatment with FPP compared with placebo. Furthermore, the lactate and myoglobin levels were improved significantly in participants with BMI ≥ 23 kg/m 2  ( p  = 0.045 and  p  = 0.011, respectively) following treatment with FPP versus placebo.
CONCLUSIONS


Our study showed that FPP supplementation significantly ameliorated fatigue-related parameters and subjective symptoms in healthy adults. Therefore, our results indicate that FPP supplementation induced anti-fatigue effect by regulating the inflammatory response.",2020,The IL-1β mRNA expression and fatigue severity scale were changed significantly after 8 weeks of treatment with fermented porcine placenta compared with placebo ( p  < 0.05).,"['Healthy Adults', 'healthy adults', '84 healthy males and females, aged between 30 and 60 years']","['Fermented Porcine Placental Extract', 'FPP', 'FPP supplementation', 'placebo', 'placebo product', 'Fermented porcine placenta (FPP', 'Placebo', 'FPP once daily or placebo']","['Fatigue-Related Parameters', 'efficacy of fatigue-inducing treadmill exercise on physical fatigue and fatigue-related parameters based on the questionnaire administered', 'Cortisol levels', 'fatigue-related parameters and subjective symptoms', 'lactate and myoglobin levels', 'IL-1β mRNA expression and fatigue severity scale']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0032048', 'cui_str': 'Placental Extracts'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0202142', 'cui_str': 'Myoglobin measurement, urine'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",84.0,0.700946,The IL-1β mRNA expression and fatigue severity scale were changed significantly after 8 weeks of treatment with fermented porcine placenta compared with placebo ( p  < 0.05).,"[{'ForeName': 'Dong Hyun', 'Initials': 'DH', 'LastName': 'Yoon', 'Affiliation': 'Health and Exercise Science Laboratory, Institute of Sports Science, Seoul National University, Seoul 08826, Korea.'}, {'ForeName': 'Ga-Young', 'Initials': 'GY', 'LastName': 'Han', 'Affiliation': 'Health and Exercise Science Laboratory, Institute of Sports Science, Seoul National University, Seoul 08826, Korea.'}, {'ForeName': 'Su Seung', 'Initials': 'SS', 'LastName': 'Hwang', 'Affiliation': 'Health and Exercise Science Laboratory, Institute of Sports Science, Seoul National University, Seoul 08826, Korea.'}, {'ForeName': 'Dong Won', 'Initials': 'DW', 'LastName': 'Lee', 'Affiliation': 'Health and Exercise Science Laboratory, Institute of Sports Science, Seoul National University, Seoul 08826, Korea.'}, {'ForeName': 'Jin-Soo', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA 6027, Australia.'}, {'ForeName': 'Keunwon', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'LG Household & Healthcare Research Park, Seoul 07795, Korea.'}, {'ForeName': 'Jongbae', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'LG Household & Healthcare Research Park, Seoul 07795, Korea.'}, {'ForeName': 'Wook', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Health and Exercise Science Laboratory, Institute of Sports Science, Seoul National University, Seoul 08826, Korea.'}]",Nutrients,['10.3390/nu12103086']
2482,33050630,Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial.,"The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF) in serum. A total of 41 FM patients were randomized into two study arms: MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual. MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes. Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment, showing large effect sizes. The number needed to treat was three based on the criteria of ≥50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP). In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum.",2020,"MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes.","['Women with Fibromyalgia', '41 FM patients']","['mindfulness plus amygdala and insula retraining (MAIR', 'Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR', 'MAIR', 'MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual', 'relaxation therapy (RT']","['pain catastrophizing and psychological inflexibility', 'BDNF', 'BDNF levels', 'immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP', 'functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion', 'immune-inflammatory markers and brain-derived neurotrophic factor (BDNF', 'clinical severity and health-related quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",41.0,0.10071,"MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes.","[{'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Sanabria-Mazo', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Barcelona, Spain.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Montero-Marin', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford OX3 7JX, UK.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Feliu-Soler', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Barcelona, Spain.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Gasión', 'Affiliation': 'Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, 50009 Zaragoza, Spain.'}, {'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Navarro-Gil', 'Affiliation': 'Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, 50009 Zaragoza, Spain.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'Morillo-Sarto', 'Affiliation': 'Basic Psychology Department, Faculty of Psychology, University of Zaragoza, 44003 Teruel, Spain.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Colomer-Carbonell', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Borràs', 'Affiliation': 'Faculty of Psychology, Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), 08193 Barcelona, Spain.'}, {'ForeName': 'Mattie', 'Initials': 'M', 'LastName': 'Tops', 'Affiliation': 'Developmental and Educational Psychology Unit, Leiden University, 233 AK Leiden, The Netherlands.'}, {'ForeName': 'Juan V', 'Initials': 'JV', 'LastName': 'Luciano', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Barcelona, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'García-Campayo', 'Affiliation': 'Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, 50009 Zaragoza, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9103246']
2483,30269273,Developmental differences between 1st and 3rd year of Early Childhood Education (preschool) in mental rotation and its training.,"Research has shown that mental rotation (MR) can be improved through training. However, studies with preschool children are very scarce, due in part to the lack of consensus as to the age at which this ability arises and can be trained, and due to the difficulties of working on the understanding of this ability when it begins to develop. The present study was designed to observe the effect of an MR training on 1st (3-4-year-old children) and 3rd year (5-6-year-old children) of Early Childhood Education (preschool), as well as the development of this ability between both courses. Finally, this study aimed to analyze the differential increase of the training effect in relation to the initial MR ability of the participants. The results showed a significant improvement in the participants who underwent training in 3rd year of preschool, with the trained group showing a marginal improvement in 1st year of preschool. The older group showed lower error rates in training performance than the younger group, the latter having a linear decrease in performance as the angular disparity increased. In addition, in relation to training, a greater increase of MR was observed in the 3rd year preschoolers with lower scores in the pretest. These results suggest that MR is in full development and that it is a spatial ability that can be trained at preschool ages. In addition, the possibility of enhancing this ability to a greater extent in preschoolers who exhibit lower initial MR level is especially relevant.",2020,"The older group showed lower error rates in training performance than the younger group, the latter having a linear decrease in performance as the angular disparity increased.","['preschool children', '1st (3-4-year-old children) and 3rd year (5-6-year-old children) of Early Childhood Education (preschool']","['MR training', 'MR']","['error rates', 'MR']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0035868', 'cui_str': 'Rotation'}]",,0.0243522,"The older group showed lower error rates in training performance than the younger group, the latter having a linear decrease in performance as the angular disparity increased.","[{'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Fernández-Méndez', 'Affiliation': 'Universidad Nacional de Educación a Distancia (UNED), Madrid, Spain. lmfernandez@bec.uned.es.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Contreras', 'Affiliation': 'Universidad Nacional de Educación a Distancia (UNED), Madrid, Spain.'}, {'ForeName': 'M Rosa', 'Initials': 'MR', 'LastName': 'Elosúa', 'Affiliation': 'Universidad Nacional de Educación a Distancia (UNED), Madrid, Spain.'}]",Psychological research,['10.1007/s00426-018-1104-6']
2484,30368558,The impact of training methodology and category structure on the formation of new categories from existing knowledge.,"Categorization decisions are made thousands of times every day, and a typical adult knows tens of thousands of categories. It is thus relatively rare that adults learn new categories without somehow reorganizing pre-existing knowledge. Yet, most perceptual categorization research has investigated the ability to learn new categories without considering they relation to existing knowledge. In this article, we test the ability of young adults to merge already known categories into new categories as a function of training methodology and category structures using two experiments. Experiment 1 tests participants' ability to merge rule-based or information-integration categories that are either contiguous, semi-contiguous, or non-contiguous in perceptual space using a classification paradigm. Experiment 2 is similar Experiment 1 but uses a YES/NO learning paradigm instead. The results of both experiments suggest a strong effect of the contiguity of the merged categories in perceptual space that depends on the type of category representation that is learned. The type of category representation that is learned, in turn, depends on a complex interaction of the category structures and training task. We conclude by discussing the relevance of these results for categorization outside the laboratory.",2020,"Experiment 1 tests participants' ability to merge rule-based or information-integration categories that are either contiguous, semi-contiguous, or non-contiguous in perceptual space using a classification paradigm.",['young adults'],[],[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],[],,0.0158009,"Experiment 1 tests participants' ability to merge rule-based or information-integration categories that are either contiguous, semi-contiguous, or non-contiguous in perceptual space using a classification paradigm.","[{'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Hélie', 'Affiliation': 'Department of Psychological Sciences, Purdue University, West Lafayette, USA. shelie@purdue.edu.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Shamloo', 'Affiliation': 'Department of Psychological Sciences, Purdue University, West Lafayette, USA.'}, {'ForeName': 'Shawn W', 'Initials': 'SW', 'LastName': 'Ell', 'Affiliation': 'Department of Psychology, University of Maine, Orono, USA.'}]",Psychological research,['10.1007/s00426-018-1115-3']
2485,31073879,Effects of Group-Based CBT on Post-Event Processing in Children with Social Anxiety Disorder Following an Experimental Social Stressor.,"Theoretical models and previous research suggest that post-event processing (PEP) after social situations maintains social anxiety disorder (SAD). To date, little is known about PEP in childhood, a critical period for disorder development, or about possible positive effects of cognitive behavioral therapy (CBT) on PEP in children. Children with SAD (n = 71; aged 9-13 years) and healthy controls (n = 55) participated in a social stress task (Trier Social Stress Test for Children, TSST-C), which was repeated in children with SAD after either 12 sessions of CBT or a waiting period. PEP was assessed daily with regard to both valence and frequency, as well as in more detail regarding specific negative and positive ruminative thoughts 1 week after each TSST-C. Daily PEP after the TSST-C was more frequent and more negative in children with SAD compared to healthy controls, in particular during the first 2 days after the TSST-C. After CBT treatment, children with SAD reported more positive PEP but not less negative PEP compared to children in the waitlist control group. The current study suggests that negative PEP in children with SAD is most pronounced in the first days following social stress. Group-based CBT seems to be effective in building up positive cognitions after social stress in children, but developing specific interventions targeting negative PEP immediately after a social stressor may be necessary to further increase treatment efficacy.",2019,"After CBT treatment, children with SAD reported more positive PEP but not less negative PEP compared to children in the waitlist control group.","['Children with Social Anxiety Disorder Following an Experimental Social Stressor', 'children with SAD', 'children', 'Children with SAD (n\xa0', '71; aged 9-13\xa0years) and healthy controls (n\xa0=\u200955) participated in a']","['PEP', 'Group-Based CBT', 'social stress task (Trier Social Stress Test for Children, TSST-C', 'cognitive behavioral therapy (CBT']","['negative PEP', 'positive PEP']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",71.0,0.0124427,"After CBT treatment, children with SAD reported more positive PEP but not less negative PEP compared to children in the waitlist control group.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Asbrand', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Freiburg, Freiburg im Breisgau, Germany. Julia.asbrand@psychologie.uni-freiburg.de.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Schmitz', 'Affiliation': 'Department for Clinical Child and Adolescent Psychology, Leipzig University, Leipzig, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Krämer', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Nitschke', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Heinrichs', 'Affiliation': 'Institute of Psychology, University of Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Brunna', 'Initials': 'B', 'LastName': 'Tuschen-Caffier', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Freiburg, Freiburg im Breisgau, Germany.'}]",Journal of abnormal child psychology,['10.1007/s10802-019-00558-x']
2486,31102063,Latent Profiles of Cognitive and Interpersonal Risk Factors for Adolescent Depression and Implications for Personalized Treatment.,"A personalized approach to treatment with patients being matched to the best-fit treatment has been proposed as one possible solution to the currently modest treatment response rates for adolescent depression. Personalized treatment involves identifying and characterizing subgroups likely to respond differently to different treatments. We investigated the feasibility of this approach, by focusing on two key risk factors that are the purported treatment targets of cognitive behavioral therapy (CBT) and interpersonal psychotherapy for depressed adolescents (IPT-A): negative unrealistic cognitions and interpersonal relationship difficulties, respectively. We sought to learn whether subgroups high and low on the two risk factors, respectively, might be identified in a large sample of depressed, treatment-seeking adolescents. Latent class analysis (LCA) was conducted on measures of the two risk factors among 431 adolescents (age 12-17) in the Treatment for Adolescents with Depression Study. LCA identified three classes: (1) adolescents with high levels of problems in both family relationships and cognitions (21.6% of sample), (2) adolescents with moderate levels of problems in both domains (52.4%), and (3) adolescents with low levels of problems in both domains (26.0%). These subgroups did not predict treatment outcome with CBT or CBT + fluoxetine (COMB). The results challenge a current assumption about how treatments could be personalized, and they support a multi-causal model of depression rather than a risk-factor-specific model. Strategies other than risk factor-based personalizing for case assignment to CBT vs. IPT-A are discussed.",2019,These subgroups did not predict treatment outcome with CBT or CBT + fluoxetine (COMB).,"['431 adolescents (age 12-17) in the Treatment for Adolescents with Depression Study', 'LCA identified three classes: (1) adolescents with high levels of problems in both family relationships and cognitions (21.6% of sample), (2) adolescents with moderate levels of problems in both domains (52.4%), and (3) adolescents with low levels of problems in both domains (26.0']","['Latent class analysis (LCA', 'cognitive behavioral therapy (CBT) and interpersonal psychotherapy', 'fluoxetine (COMB']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4704739', 'cui_str': 'Latent Variable Modeling'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0015608', 'cui_str': 'Family Relationship'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C4704739', 'cui_str': 'Latent Variable Modeling'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0376161', 'cui_str': 'Comb'}]",[],,0.0239835,These subgroups did not predict treatment outcome with CBT or CBT + fluoxetine (COMB).,"[{'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Gunlicks-Stoessel', 'Affiliation': 'Department of Psychiatry, University of Minnesota, 2450 Riverside Ave, F256/2B West, Minneapolis, MN, 55454, USA. mgunlick@umn.edu.'}, {'ForeName': 'Dikla', 'Initials': 'D', 'LastName': 'Eckshtain', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Massachusetts General Hospital, 185 Cambridge Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, 1100 Washington Avenue S, Suite 102, Minneapolis, MN, 55415, USA.""}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Reigstad', 'Affiliation': 'Department of Psychiatry, University of Minnesota, 2450 Riverside Ave, F256/2B West, Minneapolis, MN, 55454, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mufson', 'Affiliation': 'Division of Child & Adolescent Psychiatry, Columbia University College of Physicians & Surgeons and New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Weisz', 'Affiliation': 'Department of Psychology, Harvard University, 1030 William James Hall, Cambridge, MA, 02138, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-019-00552-3']
2487,31119469,Disinhibited Social Engagement Disorder in Early Childhood Predicts Reduced Competence in Early Adolescence.,"Psychosocial deprivation is associated with the development of socially aberrant behaviors, including signs of disinhibited social engagement disorder (DSED). In longitudinal studies, signs of DSED have been shown to decrease over time, especially as children are removed from conditions of deprivation. What is less clear is whether signs of DSED in early childhood are associated with poorer functioning in early adolescence, including among children who no longer manifest signs of DSED at this age. In a sample of 136 Romanian children from the Bucharest Early Intervention Project (BEIP), who were exposed to early psychosocial deprivation in the form of institutional care, we examined caregiver-reported (ages 30, 42, and 54 months and 12 years) and observer-rated (age 54 months) signs of DSED. Competent functioning in early adolescence (age 12 years) was assessed across seven domains (i.e., family relationships, peer relationships, academic performance, physical health, mental health, substance use, and risk-taking behavior). A diagnosis of DSED in early childhood was associated with reduced competence in early adolescence. Furthermore, this association was significant even when signs of DSED diminished by age 12 years. We conclude that signs of DSED in early life are associated with reduced likelihood of competent functioning many years later in adolescence, even if signs of the disorder remit.",2019,"We conclude that signs of DSED in early life are associated with reduced likelihood of competent functioning many years later in adolescence, even if signs of the disorder remit.","['136 Romanian children from the Bucharest Early Intervention Project (BEIP), who were exposed to early psychosocial deprivation in the form of institutional care, we examined caregiver-reported (ages 30, 42, and 54\xa0months and 12\xa0years) and observer-rated (age 54\xa0months) signs of DSED']",[],"['family relationships, peer relationships, academic performance, physical health, mental health, substance use, and risk-taking behavior']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0035827', 'cui_str': 'Rumanian language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0033962', 'cui_str': 'Psychosocial deprivation'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],"[{'cui': 'C0015608', 'cui_str': 'Family Relationship'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",136.0,0.0455781,"We conclude that signs of DSED in early life are associated with reduced likelihood of competent functioning many years later in adolescence, even if signs of the disorder remit.","[{'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Guyon-Harris', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Tulane University School of Medicine, 1430 Tulane Ave, #8055, New Orleans, LA, 70112, USA.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Humphreys', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Tulane University School of Medicine, 1430 Tulane Ave, #8055, New Orleans, LA, 70112, USA.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'Miron', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Tulane University School of Medicine, 1430 Tulane Ave, #8055, New Orleans, LA, 70112, USA.'}, {'ForeName': 'Mary Margaret', 'Initials': 'MM', 'LastName': 'Gleason', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Tulane University School of Medicine, 1430 Tulane Ave, #8055, New Orleans, LA, 70112, USA.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Boston Children's Hospital/Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Zeanah', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Tulane University School of Medicine, 1430 Tulane Ave, #8055, New Orleans, LA, 70112, USA. czeanah@tulane.edu.'}]",Journal of abnormal child psychology,['10.1007/s10802-019-00547-0']
2488,31924463,Transcranial alternating current stimulation induced excitatory aftereffects are abolished by decaffeinated espresso and reversed into inhibition by espresso with caffeine.,,2020,,[],['caffeine'],[],[],"[{'cui': 'C0006644', 'cui_str': 'Caffeine'}]",[],,0.0209502,,"[{'ForeName': 'Mohd Faizal Mohd', 'Initials': 'MFM', 'LastName': 'Zulkifly', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center, Georg-August University, Göttingen, Germany; Brain and Behaviour Cluster, School of Medical Science, Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia. Electronic address: mfzl_mzly@yahoo.com.'}, {'ForeName': 'Ornela', 'Initials': 'O', 'LastName': 'Merkohitaj', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center, Georg-August University, Göttingen, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Paulus', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center, Georg-August University, Göttingen, Germany.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2019.11.062']
2489,32029260,Optical Coherence Tomography Assessment for Percutaneous Coronary Intervention of the Left Main Artery: The IDEAL-LM Trial.,,2020,,['Percutaneous Coronary Intervention of the Left\xa0Main\xa0Artery'],['Optical Coherence Tomography Assessment'],[],"[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",[],,0.0266403,,"[{'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': ''}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Lesiak', 'Affiliation': ''}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Merkulov', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Kretov', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Barragan', 'Affiliation': ''}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Oldroyd', 'Affiliation': ''}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'van Geuns', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.09.012']
2490,32081246,Vascular Response After FP-PES Versus Polymer-Free Paclitaxel-Eluting Stent Implantation in Femoropopliteal Artery Lesions: A Serial Intravascular Ultrasound Study.,,2020,,['Femoropopliteal Artery Lesions'],['FP-PES\xa0Versus Polymer-Free Paclitaxel-Eluting Stent\xa0Implantation'],['Vascular Response'],"[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]",,0.0194262,,"[{'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Tomoi', 'Affiliation': ''}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Kuramitsu', 'Affiliation': ''}, {'ForeName': 'Yoshimitsu', 'Initials': 'Y', 'LastName': 'Soga', 'Affiliation': ''}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Fujihara', 'Affiliation': ''}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Iida', 'Affiliation': ''}, {'ForeName': 'Daizo', 'Initials': 'D', 'LastName': 'Kawasaki', 'Affiliation': ''}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.08.043']
2491,33052754,Equivalence Randomized Trial to Compare Treatment on the Basis of Sentinel Node Biopsy Versus Neck Node Dissection in Operable T1-T2N0 Oral and Oropharyngeal Cancer.,"PURPOSE


Sentinel node (SN) biopsy is accurate in operable oral and oropharyngeal cT1-T2N0 cancer (OC), but, to our knowledge, the oncologic equivalence of SN biopsy and neck lymph node dissection (ND; standard treatment) has never been evaluated.
METHODS


In this phase III multicenter trial, 307 patients with OC were randomly assigned to (1) the ND arm or (2) the SN arm (experimental arm: biopsy alone if negative, or followed by ND if positive, during primary tumor surgery). The primary outcome was neck node recurrence-free survival (RFS) at 2 years. Secondary outcomes were 5-year neck node RFS, 2- and 5-year disease-specific survival (DSS), and overall survival (OS). Other outcomes were hospital stay length, neck and shoulder morbidity, and number of physiotherapy prescriptions during the 2 years after surgery.
RESULTS


Data on 279 patients (139 ND and 140 SN) could be analyzed. Neck node RFS was 89.6% (95% CI, 0.83% to 0.94%) at 2 years in the ND arm and 90.7% (95% CI, 0.84% to 0.95%) in the SN arm, confirming the equivalence with  P  < .01. The 5-year RFS and the 2- and 5-year DSS and OS were not significantly different between arms. The median hospital stay length was 8 days in the ND arm and 7 days in the SN arm ( P  < .01). The functional outcomes were significantly worse in the ND arm until 6 months after surgery.
CONCLUSION


This study demonstrated the oncologic equivalence of the SN and ND approaches, with lower morbidity in the SN arm during the first 6 months after surgery, thus establishing SN as the standard of care in OC.",2020,The 5-year RFS and the 2- and 5-year DSS and OS were not significantly different between arms.,"['Operable T1-T2N0 Oral and Oropharyngeal Cancer', '307 patients with OC', '279 patients (139 ND and 140 SN']","['SN arm (experimental arm: biopsy alone if negative, or followed by ND if positive, during primary tumor surgery', 'Sentinel node (SN) biopsy', 'Sentinel Node Biopsy Versus Neck Node Dissection']","['hospital stay length, neck and shoulder morbidity, and number of physiotherapy prescriptions', '5-year RFS and the 2- and 5-year DSS and OS', 'Neck node RFS', 'median hospital stay length', 'neck node recurrence-free survival (RFS', '5-year neck node RFS, 2- and 5-year disease-specific survival (DSS), and overall survival (OS']","[{'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C1438035', 'cui_str': 'SLC6A8 protein, human'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}]","[{'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0011195', 'cui_str': 'Déjérine-Sottas disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",307.0,0.134481,The 5-year RFS and the 2- and 5-year DSS and OS were not significantly different between arms.,"[{'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Garrel', 'Affiliation': 'Head Neck Surgery Department, Montpellier University Hospital Center, Montpellier, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Poissonnet', 'Affiliation': 'Head Neck Surgery Department, Antoine Lacassagne Center, Nice, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Moyà Plana', 'Affiliation': 'Head Neck Surgery Department, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Fakhry', 'Affiliation': 'Head Neck Surgery Department, Marseille University Hospital Center, Marseille, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Dolivet', 'Affiliation': 'Head Neck Surgery Department, Alexis Vautrin Center, Vandœuvre-lès-Nancy, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lallemant', 'Affiliation': 'Head Neck Surgery Department, Nîmes University Hospital Center, Nîmes, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Sarini', 'Affiliation': 'Head Neck Surgery Department, Toulouse Oncopole, Toulouse, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Vergez', 'Affiliation': 'Head Neck Surgery Department, Toulouse Oncopole, Toulouse, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Guelfucci', 'Affiliation': 'Head Neck Surgery Department, Toulon Hospital Center, Toulon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Choussy', 'Affiliation': 'Head Neck Surgery Department, Curie Institute, Paris, France.'}, {'ForeName': 'Vianney', 'Initials': 'V', 'LastName': 'Bastit', 'Affiliation': 'Head Neck Surgery Department, François Baclesse Center, Caen, France.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Richard', 'Affiliation': 'Head Neck Surgery Department, Montpellier University Hospital Center, Montpellier, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Costes', 'Affiliation': 'Pathology Department, Montpellier University Hospital Center, Montpellier, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Landais', 'Affiliation': 'Clinical Research University Institute, UPRES EA 2415, Montpellier, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Perriard', 'Affiliation': 'Clinical Research University Institute, UPRES EA 2415, Montpellier, France.'}, {'ForeName': 'Jean Pierre', 'Initials': 'JP', 'LastName': 'Daures', 'Affiliation': 'Clinical Research University Institute, UPRES EA 2415, Montpellier, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'de Verbizier', 'Affiliation': 'Nuclear Medicine Department, Montpellier University Hospital Center, Montpellier, France.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Favier', 'Affiliation': 'Head Neck Surgery Department, Montpellier University Hospital Center, Montpellier, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'de Boutray', 'Affiliation': 'Head Neck Surgery Department, Montpellier University Hospital Center, Montpellier, France.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01661']
2492,33052757,ARTSCAN III: A Randomized Phase III Study Comparing Chemoradiotherapy With Cisplatin Versus Cetuximab in Patients With Locoregionally Advanced Head and Neck Squamous Cell Cancer.,"PURPOSE


We performed an open-label randomized controlled phase III study comparing treatment outcome and toxicity between radiotherapy (RT) with concomitant cisplatin versus concomitant cetuximab in patients with locoregionally advanced head and neck squamous cell carcinoma (HNSCC; stage III-IV according to the Union for International Cancer Control TNM classification, 7th edition).
MATERIALS AND METHODS


Eligible patients were randomly assigned 1:1 to receive either intravenous cetuximab 400 mg/m 2  1 week before start of RT followed by 250 mg/m 2 /wk, or weekly intravenous cisplatin 40 mg/m 2 , during RT. RT was conventionally fractionated. Patients with T3-T4 tumors underwent a second random assignment 1:1 between standard RT dose 68.0 Gy to the primary tumor or dose escalation to 73.1 Gy. Primary end point was overall survival (OS) evaluated using adjusted Cox regression analysis. Secondary end points were locoregional control, local control with dose-escalated RT, pattern of failure, and adverse effects.
RESULTS


Study inclusion was prematurely closed after an unplanned interim analysis when 298 patients had been randomly assigned. At 3 years, OS was 88% (95% CI, 83% to 94%) and 78% (95% CI, 71% to 85%) in the cisplatin and cetuximab groups, respectively (adjusted hazard ratio, 1.63; 95% CI, 0.93 to 2.86;  P  = .086). The cumulative incidence of locoregional failures at 3 years was 23% (95% CI, 16% to 31%) compared with 9% (95% CI, 4% to 14%) in the cetuximab versus the cisplatin group (Gray's test  P  = .0036). The cumulative incidence of distant failures did not differ between the treatment groups. Dose escalation in T3-T4 tumors did not increase local control.
CONCLUSION


Cetuximab is inferior to cisplatin regarding locoregional control for concomitant treatment with RT in patients with locoregionally advanced HNSCC. Additional studies are needed to identify possible subgroups that still may benefit from concomitant cetuximab treatment.",2020,"CONCLUSION


Cetuximab is inferior to cisplatin regarding locoregional control for concomitant treatment with RT in patients with locoregionally advanced HNSCC.","['Eligible patients', 'Patients with T3-T4 tumors', 'Patients', 'patients with locoregionally advanced head and neck squamous cell carcinoma (HNSCC; stage III-IV according to the Union for International Cancer Control', '298 patients had been randomly assigned', 'patients with locoregionally advanced HNSCC', 'With Locoregionally Advanced Head and Neck Squamous Cell Cancer']","['intravenous cetuximab 400 mg/m 2  1 week before start of RT followed by 250 mg/m 2 /wk, or weekly intravenous cisplatin', 'cisplatin', 'cisplatin and cetuximab', 'radiotherapy (RT) with concomitant cisplatin versus concomitant cetuximab', 'Chemoradiotherapy With Cisplatin Versus Cetuximab']","['cumulative incidence of locoregional failures', 'overall survival (OS', 'cumulative incidence of distant failures', 'locoregional control, local control with dose-escalated RT, pattern of failure, and adverse effects', 'local control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C1449035', 'cui_str': 'SPRR2A protein, human'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.104818,"CONCLUSION


Cetuximab is inferior to cisplatin regarding locoregional control for concomitant treatment with RT in patients with locoregionally advanced HNSCC.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gebre-Medhin', 'Affiliation': 'Department of Hematology, Oncology, and Radiation Physics, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Brun', 'Affiliation': 'Department of Hematology, Oncology, and Radiation Physics, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Engström', 'Affiliation': 'Department of Hematology, Oncology, and Radiation Physics, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Hedda', 'Initials': 'H', 'LastName': 'Haugen Cange', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Lalle', 'Initials': 'L', 'LastName': 'Hammarstedt-Nordenvall', 'Affiliation': 'Division of Ear, Nose, and Throat Diseases, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Reizenstein', 'Affiliation': 'Department of Oncology, Örebro University Hospital, Örebro, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Nyman', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Edvard', 'Initials': 'E', 'LastName': 'Abel', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Friesland', 'Affiliation': 'Theme Cancer, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Sjödin', 'Affiliation': 'Theme Cancer, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Carlsson', 'Affiliation': 'Department of Hematology, Oncology, and Radiation Physics, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Söderkvist', 'Affiliation': 'Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Thomasson', 'Affiliation': 'Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Zackrisson', 'Affiliation': 'Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nilsson', 'Affiliation': 'Department of Hematology, Oncology, and Radiation Physics, Skåne University Hospital, Lund University, Lund, Sweden.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02072']
2493,33052759,Adjuvant Sorafenib for Renal Cell Carcinoma at Intermediate or High Risk of Relapse: Results From the SORCE Randomized Phase III Intergroup Trial.,"PURPOSE


SORCE is an international, randomized, double-blind, three-arm trial of sorafenib after surgical excision of primary renal cell carcinoma (RCC) found to be at intermediate or high risk of recurrence.
PATIENTS AND METHODS


We randomly assigned participants (2:3:3) to 3 years of placebo (arm A), 1 year of sorafenib followed by 2 years of placebo (arm B), or 3 years of sorafenib (arm C). The initial sorafenib dose was 400 mg twice per day orally, amended to 400 mg daily. The primary outcome analysis, which was revised as a result of external results, was investigator-reported disease-free survival (DFS) comparing 3 years of sorafenib versus placebo.
RESULTS


Between July 2007 and April 2013, we randomly assigned 1,711 participants (430, 642, and 639 participants in arms A, B, and C, respectively). Median age was 58 years, 71% of patients were men, 84% had clear cell histology, 53% were at intermediate risk of recurrence, and 47% were at high risk of recurrence. We observed no differences in DFS or overall survival in all randomly assigned patients, patients with high risk of recurrence, or patients with clear cell RCC only. Median DFS was not reached for 3 years of sorafenib or for placebo (hazard ratio, 1.01; 95% CI, 0.83 to 1.23;  P  = .95). We observed nonproportional hazards; the restricted mean survival time (RMST) was 6.81 years for 3 years of sorafenib and 6.82 years for placebo (RMST difference, 0.01 year; 95% CI, -0.49 to 0.48 year;  P  = .99). Despite offering treatment adaptations, more than half of participants stopped treatment by 12 months. Grade 3 hand-foot skin reaction was reported in 24% of participants on sorafenib.
CONCLUSION


Sorafenib should not be used as adjuvant therapy for RCC. Active surveillance remains the standard of care for patients at intermediate or high risk of recurrence after nephrectomy and is the appropriate control of our current international adjuvant RCC trial, RAMPART.",2020,"Median DFS was not reached for 3 years of sorafenib or for placebo (hazard ratio, 1.01; 95% CI, 0.83 to 1.23;  P  = .95).","['We randomly assigned participants (2:3:3) to 3 years of', 'Between July 2007 and April 2013, we randomly assigned 1,711 participants (430, 642, and 639 participants in arms A, B, and C, respectively', 'Renal Cell Carcinoma at Intermediate or High Risk of Relapse', 'primary renal cell carcinoma (RCC']","['sorafenib followed by 2 years of placebo', 'Adjuvant Sorafenib', 'Sorafenib', 'placebo', 'sorafenib']","['DFS or overall survival', 'disease-free survival (DFS', 'Median DFS', 'Grade 3 hand-foot skin reaction', 'mean survival time (RMST']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}]",1711.0,0.624039,"Median DFS was not reached for 3 years of sorafenib or for placebo (hazard ratio, 1.01; 95% CI, 0.83 to 1.23;  P  = .95).","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Eisen', 'Affiliation': 'Department of Oncology, Cambridge University Hospitals National Health Service (NHS) Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Frangou', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London (UCL), Institute of Clinical Trials and Methodology, London, United Kingdom.'}, {'ForeName': 'Bhavna', 'Initials': 'B', 'LastName': 'Oza', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London (UCL), Institute of Clinical Trials and Methodology, London, United Kingdom.'}, {'ForeName': 'Alastair W S', 'Initials': 'AWS', 'LastName': 'Ritchie', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London (UCL), Institute of Clinical Trials and Methodology, London, United Kingdom.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Smith', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London (UCL), Institute of Clinical Trials and Methodology, London, United Kingdom.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Kaplan', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London (UCL), Institute of Clinical Trials and Methodology, London, United Kingdom.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Davis', 'Affiliation': 'Monash University and Eastern Health, Box Hill, Victoria, Australia.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Stockler', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, Central Clinical School, Department of Medicine, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'The Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Bex', 'Affiliation': 'Royal Free London NHS Foundation Trust UCL, Division of Surgery and Interventional Science, London, United Kingdom.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Joniau', 'Affiliation': 'Department of Development and Regeneration, Urogenital, Abdominal, and Plastic Surgery, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Hancock', 'Affiliation': 'University of Sheffield, Academic Unit of Clinical Oncology, Weston Park Cancer Centre, Sheffield, United Kingdom.'}, {'ForeName': 'Gregers G', 'Initials': 'GG', 'LastName': 'Hermann', 'Affiliation': 'Urology Research Unit, Department of Urology, Herlev/Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bellmunt', 'Affiliation': 'Beth Israel Deaconess Medical Center-IMIM Research Lab, Boston, MA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hodgkinson', 'Affiliation': 'Pharmacy Department, Weston Park Hospital, Sheffield, United Kingdom.'}, {'ForeName': 'Grant D', 'Initials': 'GD', 'LastName': 'Stewart', 'Affiliation': ""Department of Surgery, University of Cambridge, Addenbrooke's Hospital, Cambridge, United Kingdom.""}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Barber', 'Affiliation': 'Velindre Cancer Centre, Cardiff, United Kingdom.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Academic Unit of Clinical Oncology, Weston Park Hospital, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Rhona', 'Initials': 'R', 'LastName': 'McMenemin', 'Affiliation': 'Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Nathan', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, United Kingdom.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Pickering', 'Affiliation': 'The Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Mahesh K B', 'Initials': 'MKB', 'LastName': 'Parmar', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London (UCL), Institute of Clinical Trials and Methodology, London, United Kingdom.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Meade', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London (UCL), Institute of Clinical Trials and Methodology, London, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01800']
2494,33052762,"Proof of Concept for a Mindfulness-Informed Intervention for Eating Disorder Symptoms, Self-Efficacy, and Emotion Regulation among Bariatric Surgery Candidates.","Up to 64% of patients seeking bariatric (weight-loss) surgery report eating disorder (ED) symptoms (addictive-like eating, binge eating, emotional eating, grazing) that can interfere with post-surgical weight loss. This prospective proof-of-concept study aimed to evaluate the impact of a pre-surgical mindfulness-informed intervention (MII) on ED symptoms and potential mechanisms-of-action to inform optimization of the intervention. Surgery-seeking adults attended four, 2-hour, MII sessions held weekly. Participants completed validated questionnaires assessing ED symptoms, eating self-efficacy, emotion regulation, and mindful eating pre-MII, post-MII, and at a 12-week follow-up. The MII consisted of mindfulness training, with cognitive, behavioral, and psychoeducational components. Fifty-six patients ( M  = 47.41 years old, 89.3% female) participated. Improvements in addictive-like eating, binge eating, emotional eating, and grazing were observed from pre- to post-MII. ED symptom treatment gains were either maintained or improved further at 12-week follow-up. Eating self-efficacy and emotion regulation improved from pre-MII to follow-up. Scores on the mindful eating questionnaire deteriorated from pre-MII to follow-up. In mediation analyses, there was a combined indirect effect of emotion regulation, eating self-efficacy, and mindful eating on grazing and binge eating, and an indirect effect of emotion regulation on emotional eating and addictive-like eating. Participation in the MII was associated with improvements in ED symptoms and some mechanisms-of-action, establishing proof-of-concept for the intervention. Future work to establish the MII's efficacy in a randomized controlled trial is warranted.",2020,"Improvements in addictive-like eating, binge eating, emotional eating, and grazing were observed from pre- to post-MII.","['Fifty-six patients ( M \u2009=\u200947.41\u2009years old, 89.3% female) participated']",['pre-surgical mindfulness-informed intervention (MII'],"['emotional eating and addictive-like eating', 'seeking bariatric (weight-loss) surgery report eating disorder (ED) symptoms (addictive-like eating, binge eating, emotional eating, grazing', 'addictive-like eating, binge eating, emotional eating, and grazing', 'Eating Disorder Symptoms, Self-Efficacy, and Emotion Regulation', 'Eating self-efficacy and emotion regulation', 'validated questionnaires assessing ED symptoms, eating self-efficacy, emotion regulation, and mindful eating pre-MII, post-MII', 'mindful eating questionnaire', 'emotion regulation, eating self-efficacy, and mindful eating on grazing and binge eating']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",,0.0229664,"Improvements in addictive-like eating, binge eating, emotional eating, and grazing were observed from pre- to post-MII.","[{'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Felske', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Tamara M', 'Initials': 'TM', 'LastName': 'Williamson', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Rash', 'Affiliation': ""Department of Psychology, Memorial University of Newfoundland, St. John's, NL, Canada.""}, {'ForeName': 'Jo Ann', 'Initials': 'JA', 'LastName': 'Telfer', 'Affiliation': 'Calgary Adult Bariatric Surgery Clinic, Alberta Health Services, Richmond Road Diagnostic and Treatment Services, Calgary, AB, Canada.'}, {'ForeName': 'Kirsti I', 'Initials': 'KI', 'LastName': 'Toivonen', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Tavis', 'Initials': 'T', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, AB, Canada.'}]","Behavioral medicine (Washington, D.C.)",['10.1080/08964289.2020.1828255']
2495,33052785,"Re: Group-Based vs Individual Pelvic Floor Muscle Training to Treat Urinary Incontinence in Women, a Randomized Clinical Trial.",,2020,,[],['Individual Pelvic Floor Muscle Training'],[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]",[],,0.0714689,,"[{'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001286.02']
2496,33052786,"Re: Safety and Efficacy of Mirabegron: Analysis of a Large Integrated Clinical Trial Database of Patients with Overactive Bladder Receiving Mirabegron, Antimuscarinics, or Placebo.",,2020,,"['Patients with Overactive Bladder Receiving Mirabegron, Antimuscarinics, or']","['Mirabegron', 'Placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}]","[{'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.184078,,"[{'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001286']
2497,33052796,Impact of wound duration on diabetic foot ulcer healing: evaluation of a new sucrose octasulfate wound dressing.,"OBJECTIVE


A common and frequent complication of diabetes is diabetic foot ulcers (DFU), which can have high treatment costs and severe adverse events. This study aims to evaluate the effects of wound duration on wound healing and the impact on costs, including treatment with a new sucrose octasulfate dressing compared with a control dressing.
METHOD


Based on the Explorer study (a two-armed randomised double-blind clinical trial), a cost-effectiveness analysis compared four different patient groups distinguished by their wound duration and additionally two DFU treatment options: a sucrose octasulfate dressing and a neutral dressing (as control). Clinical outcomes and total direct costs of wound dressings were evaluated over 20 weeks from the perspective of the Social Health Insurance in Germany. Simulation of long-term outcomes and costs were demonstrated by a five cycle Markov model.
RESULTS


The results show total wound healing rates between 71% and 14.8%, and direct treatment costs for DFU in the range of €2482-3278 (sucrose octasulfate dressing) and €2768-3194 (control dressing). Patients with a wound duration of ≤2 months revealed the highest wound healing rates for both the sucrose octasulfate dressing and control dressing (71% and 41%, respectively) and had the lowest direct treatment costs of €2482 and €2768, respectively. The 100-week Markov model amplified the results. Patients with ≤2 months' wound duration achieved wound healing rates of 98% and 88%, respectively and costs of €3450 and €6054, respectively (CE=€3520, €6864). Sensitivity analysis revealed that the dressing changes per week were the most significant uncertainty factor.
CONCLUSION


Based on the findings of this study, early treatment of DFU with a sucrose octasulfate dressing is recommended from a health economic view due to lower treatment costs, greater cost-effectiveness and higher wound healing rates.",2020,"Patients with a wound duration of ≤2 months revealed the highest wound healing rates for both the sucrose octasulfate dressing and control dressing (71% and 41%, respectively) and had the lowest direct treatment costs of €2482 and €2768, respectively.",['diabetic foot ulcer healing'],"['sucrose octasulfate dressing and a neutral dressing (as control', 'wound duration', 'new sucrose octasulfate dressing']","['wound healing rates', 'total direct costs of wound dressings', 'total wound healing rates', 'highest wound healing rates']","[{'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0075479', 'cui_str': 'sucrose octasulfate'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0460765', 'cui_str': 'Wound management dressing'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0344403,"Patients with a wound duration of ≤2 months revealed the highest wound healing rates for both the sucrose octasulfate dressing and control dressing (71% and 41%, respectively) and had the lowest direct treatment costs of €2482 and €2768, respectively.","[{'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Lobmann', 'Affiliation': 'Klinikum Stuttgart - Krankenhaus Bad Cannstatt, Stuttgart.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Grünerbel', 'Affiliation': 'Diabeteszentrum München Süd, München.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Lawall', 'Affiliation': 'Gemeinschaftspraxis Prof. Dr. med. Curt Diehm, Dr. med. Holger Lawall, Ettlingen.'}, {'ForeName': 'Claas', 'Initials': 'C', 'LastName': 'Lüdemann', 'Affiliation': 'Evangelisches Waldkrankenhaus Spandau, Ein Unternehmen der Paul Gerhardt Diakonie, Berlin.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Morbach', 'Affiliation': 'Marienkrankenhaus Soest, Soest.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Tigges', 'Affiliation': 'Wundzentrum Hamburg, Hamburg.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Völkel', 'Affiliation': 'Institute of Empirical Health Economics, Burscheid, Germany.'}, {'ForeName': 'Reinhard Pt', 'Initials': 'RP', 'LastName': 'Rychlik', 'Affiliation': 'Institute of Empirical Health Economics, Burscheid, Germany.'}]",Journal of wound care,['10.12968/jowc.2020.29.10.543']
2498,33052809,Effect of an Aerosol Box on Intubation in Simulated Emergency Department Airways: A Randomized Crossover Study.,"INTRODUCTION


The use of transparent plastic aerosol boxes as protective barriers during endotracheal intubation has been advocated during the severe acute respiratory syndrome coronavirus 2 pandemic. There is evidence of worldwide distribution of such devices, but some experts have warned of possible negative impacts of their use. The objective of this study was to measure the effect of an aerosol box on intubation performance across a variety of simulated difficult airway scenarios in the emergency department.
METHODS


This was a randomized, crossover design study. Participants were randomized to intubate one of five airway scenarios with and without an aerosol box in place, with randomization of intubation sequence. The primary outcome was time to intubation. Secondary outcomes included number of intubation attempts, Cormack-Lehane view, percent of glottic opening, and resident physician perception of intubation difficulty.
RESULTS


Forty-eight residents performed 96 intubations. Time to intubation was significantly longer with box use than without (mean 17 seconds [range 6-68 seconds] vs mean 10 seconds [range 5-40 seconds], p <0.001). Participants perceived intubation as being significantly more difficult with the aerosol box. There were no significant differences in the number of attempts or quality of view obtained.
CONCLUSION


Use of an aerosol box during difficult endotracheal intubation increases the time to intubation and perceived difficulty across a range of simulated ED patients.",2020,"Time to intubation was significantly longer with box use than without (mean 17 seconds [range 6-68 seconds] vs mean 10 seconds [range 5-40 seconds], p <0.001).","['Simulated Emergency Department Airways', 'Forty-eight residents performed 96 intubations']","['five airway scenarios with and without an aerosol box in place, with randomization of intubation sequence', 'aerosol box', 'transparent plastic aerosol boxes', 'Aerosol Box']","['Time to intubation', 'time to intubation', 'number of intubation attempts, Cormack-Lehane view, percent of glottic opening, and resident physician perception of intubation difficulty', 'number of attempts or quality of view obtained']","[{'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0032167', 'cui_str': 'Plastic'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}]",,0.239228,"Time to intubation was significantly longer with box use than without (mean 17 seconds [range 6-68 seconds] vs mean 10 seconds [range 5-40 seconds], p <0.001).","[{'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Turner', 'Affiliation': 'Indiana University School of Medicine, Department of Emergency Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Falvo', 'Affiliation': 'Indiana University School of Medicine, Department of Emergency Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Rami A', 'Initials': 'RA', 'LastName': 'Ahmed', 'Affiliation': 'Indiana University School of Medicine, Department of Emergency Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Ellender', 'Affiliation': 'Indiana University School of Medicine, Department of Emergency Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Corson-Knowles', 'Affiliation': 'Indiana University School of Medicine, Department of Emergency Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Bona', 'Affiliation': 'Indiana University School of Medicine, Department of Emergency Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Elisa J', 'Initials': 'EJ', 'LastName': 'Sarmiento', 'Affiliation': 'Indiana University School of Medicine, Department of Emergency Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Dylan D', 'Initials': 'DD', 'LastName': 'Cooper', 'Affiliation': 'Indiana University School of Medicine, Department of Emergency Medicine, Indianapolis, Indiana.'}]",The western journal of emergency medicine,['10.5811/westjem.2020.8.48901']
2499,33052903,Validation of the Unesp-Botucatu composite scale to assess acute postoperative abdominal pain in sheep (USAPS).,"A scale with robust statistical validation is essential to diagnose pain and improve decision making for analgesia. This blind, randomised, prospective and opportunist study aimed to develop an ethogram to evaluate behaviour and validate a scale to assess acute ovine postoperative pain. Elective laparoscopy was performed in 48 healthy sheep, filmed at one preoperative and three postoperative moments, before and after rescue analgesia and 24 hours after. The videos were randomised and assessed twice by four evaluators, with a one-month interval between evaluations. Statistical analysis was performed using R software and differences were considered significant when p <0.05. Based on the multiple association, a unidimensional scale was adopted. The intra- and inter-observer reliability ranged from moderate to very good (intraclass correlation coefficient ≥ 0.53). The scale presented Spearman correlations > 0.80 with the numerical, simple descriptive, and visual analogue scales, and a correlation of 0.48 with the facial expression scale. According to the mixed linear model, the scale was responsive, due to the increase and decrease in pain scores of all items after surgery and analgesic intervention, respectively. All items on the scale demonstrated an acceptable Spearman item-total correlation (0.56-0.76), except for appetite (0.25). The internal consistency was excellent (Cronbach's α = 0.81) and all items presented specificity > 0.72 and sensitivity between 0.61-0.90, except for appetite. According to the Youden index, the cut-off point was ≥ 4 out of 12, with a diagnostic uncertainty zone of 4 to 5. The area under the curve > 0.95 demonstrated the excellent discriminatory capacity of the instrument. In conclusion, the Unesp-Botucatu pain scale in sheep submitted to laparoscopy is valid, reliable, specific, sensitive, with excellent internal consistency, accuracy, discriminatory capacity, and a defined cut-off point.",2020,The intra- and inter-observer reliability ranged from moderate to very good (intraclass correlation coefficient ≥ 0.53).,"['48 healthy sheep', 'sheep (USAPS']",['Elective laparoscopy'],"['Unesp-Botucatu pain scale', 'facial expression scale', 'pain scores']","[{'cui': 'C0036945', 'cui_str': 'Genus Ovis'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",48.0,0.0194405,The intra- and inter-observer reliability ranged from moderate to very good (intraclass correlation coefficient ≥ 0.53).,"[{'ForeName': 'Nuno Emanuel Oliveira Figueiredo', 'Initials': 'NEOF', 'LastName': 'Silva', 'Affiliation': 'Department of Veterinary Surgery and Animal Reproduction, School of Veterinary Medicine and Animal Science, São Paulo State University (Unesp), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Pedro Henrique Esteves', 'Initials': 'PHE', 'LastName': 'Trindade', 'Affiliation': 'Department of Veterinary Surgery and Animal Reproduction, School of Veterinary Medicine and Animal Science, São Paulo State University (Unesp), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Alice Rodrigues', 'Initials': 'AR', 'LastName': 'Oliveira', 'Affiliation': 'Department of Veterinary Surgery and Animal Reproduction, School of Veterinary Medicine and Animal Science, São Paulo State University (Unesp), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Marilda Onghero', 'Initials': 'MO', 'LastName': 'Taffarel', 'Affiliation': 'Department of Veterinary Medicine, State University of Maringá, Umuarama, Paraná, Brazil.'}, {'ForeName': 'Maria Alice Pires', 'Initials': 'MAP', 'LastName': 'Moreira', 'Affiliation': 'Goiano Federal Institute, Urutaí Campus, Department of Veterinary Medicine, Urutaí, GO, Brazil.'}, {'ForeName': 'Renan', 'Initials': 'R', 'LastName': 'Denadai', 'Affiliation': 'Department of Veterinary Surgery and Animal Reproduction, School of Veterinary Medicine and Animal Science, São Paulo State University (Unesp), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Paula Barreto', 'Initials': 'PB', 'LastName': 'Rocha', 'Affiliation': 'Department of Veterinary Surgery and Animal Reproduction, School of Veterinary Medicine and Animal Science, São Paulo State University (Unesp), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Stelio Pacca Loureiro', 'Initials': 'SPL', 'LastName': 'Luna', 'Affiliation': 'Department of Veterinary Surgery and Animal Reproduction, School of Veterinary Medicine and Animal Science, São Paulo State University (Unesp), Botucatu, São Paulo, Brazil.'}]",PloS one,['10.1371/journal.pone.0239622']
2500,33052906,Association between behavioral phenotypes and response to a physical activity intervention using gamification and social incentives: Secondary analysis of the STEP UP randomized clinical trial.,"Participants often vary in their response to behavioral interventions, but methods to identify groups of participants that are more likely to respond are lacking. In this secondary analysis of a randomized clinical trial, we used baseline characteristics to group participants into distinct behavioral phenotypes and evaluated differential responses to a physical activity intervention. Latent class analysis was used to segment participants based on baseline participant data including demographics, validated measures of psychosocial variables, and physical activity behavior. The trial included 602 adults from 40 U.S. states with body mass index ≥25 who were randomized to control or one of three gamification interventions (supportive, collaborative, or competitive) to increase physical activity. Daily step counts were monitored using a wearable device for a 24-week intervention with 12 weeks of follow-up. The model segmented participants into three classes named for key defining traits: Class 1, extroverted and motivated; Class 2, less active and less social; Class 3, less motivated and at-risk. Adjusted regression models were used to test for differences in intervention response relative to control within each behavioral phenotype. In Class 1, only participants in the competitive arm increased their mean daily steps during the intervention (adjusted difference, 945; 95% CI, 352-1537; P = .002), but it was not sustained during follow-up. In Class 2, participants in all three gamification arms significantly increased their mean daily steps compared to control during the intervention (supportive arm adjusted difference 1172; 95% CI, 363-1980; P = .005; collaborative arm adjusted difference 1119; 95% CI, 319-1919; P = .006; competitive arm adjusted difference 1179; 95% CI, 400-1957; P = .003) and all three had sustained impact during follow-up. In Class 3, none of the interventions had a significant effect on physical activity. Three behavioral phenotypes were identified, each with a different response to the interventions. This approach could be used to better target behavioral interventions to participants that are more likely to respond to them.",2020,"In Class 2, participants in all three gamification arms significantly increased their mean daily steps compared to control during the intervention (supportive arm adjusted difference 1172; 95% CI, 363-1980; P = .005; collaborative arm adjusted difference 1119; 95% CI, 319-1919; P = .006; competitive arm adjusted difference 1179; 95% CI, 400-1957; P = .003) and all three had sustained impact during follow-up.","['group participants into distinct behavioral phenotypes and evaluated differential responses to a physical activity intervention', 'model segmented participants into three classes named for key defining traits: Class 1, extroverted and motivated; Class 2, less active and less social; Class 3, less motivated and at-risk', '602 adults from 40 U.S. states with body mass index ≥25 who were randomized to control or one of three']","['physical activity intervention', 'gamification interventions (supportive, collaborative, or competitive']","['mean daily steps', 'physical activity']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1321146', 'cui_str': 'Behavioral phenotype'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",602.0,0.0609845,"In Class 2, participants in all three gamification arms significantly increased their mean daily steps compared to control during the intervention (supportive arm adjusted difference 1172; 95% CI, 363-1980; P = .005; collaborative arm adjusted difference 1119; 95% CI, 319-1919; P = .006; competitive arm adjusted difference 1179; 95% CI, 400-1957; P = .003) and all three had sustained impact during follow-up.","[{'ForeName': 'Xisui Shirley', 'Initials': 'XS', 'LastName': 'Chen', 'Affiliation': 'Department of Medicine, University of Pennyslvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Sujatha', 'Initials': 'S', 'LastName': 'Changolkar', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennyslvania, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Amol S', 'Initials': 'AS', 'LastName': 'Navathe', 'Affiliation': 'Department of Medicine, University of Pennyslvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Linn', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, University of Pennyslvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reh', 'Affiliation': 'Deloitte Consulting, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Szwartz', 'Affiliation': 'Deloitte Consulting, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Steier', 'Affiliation': 'Deloitte Consulting, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Godby', 'Affiliation': 'Deloitte Consulting, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Balachandran', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennyslvania, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Harrison', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennyslvania, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Charles A L', 'Initials': 'CAL', 'LastName': 'Rareshide', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennyslvania, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, University of Pennyslvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States of America.'}]",PloS one,['10.1371/journal.pone.0239288']
2501,33052922,Emotional flexibility and general self-efficacy: A pilot training intervention study with knowledge workers.,"Emotional flexibility advancement has been found to be highly effective in clinical settings to treat, for example, depression, anxiety, and chronic pain. Developing these skills in the working context has also shown very encouraging results in public sector settings. Also, a few studies have revealed effectiveness in a private sector setting, but no studies have yet looked at the effectiveness of developing these skills amongst high-paced, high-demanding, and highly-educated knowledge workers. In this pilot training intervention study, we report evidence that emotional flexibility can be developed in this context. We conducted an experiment with treatment and control groups, with only the treatment group receiving an emotional flexibility training. Emotional flexibility improved significantly for the treatment group, whereas the improvements were minimal or negative for the control group. Furthermore, we reveal that General self-efficacy improved amongst treatment group participants (and not for control group participants), and that this is associated with emotional flexibility. Finally, we show that the improvements were higher for participants starting from a lower baseline.",2020,"Emotional flexibility improved significantly for the treatment group, whereas the improvements were minimal or negative for the control group.",['knowledge workers'],['emotional flexibility training'],"['Emotional flexibility', 'General self-efficacy', 'Emotional flexibility and general self-efficacy']","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0276821,"Emotional flexibility improved significantly for the treatment group, whereas the improvements were minimal or negative for the control group.","[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Brassey', 'Affiliation': 'Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Arjen van', 'Initials': 'AV', 'LastName': 'Witteloostuijn', 'Affiliation': 'Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Csaba', 'Initials': 'C', 'LastName': 'Huszka', 'Affiliation': 'Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Silberzahn', 'Affiliation': 'McKinsey & Company, Berlin, Germany.'}, {'ForeName': 'Nick van', 'Initials': 'NV', 'LastName': 'Dam', 'Affiliation': 'IE University, Segovia, Spain.'}]",PloS one,['10.1371/journal.pone.0237821']
2502,33052965,"The cost-effectiveness of MDMA-assisted psychotherapy for the treatment of chronic, treatment-resistant PTSD.","BACKGROUND


Chronic posttraumatic stress disorder (PTSD) is a disabling condition that generates considerable morbidity, mortality, and both medical and indirect social costs. Treatment options are limited. A novel therapy using 3,4-methylenedioxymethamphetamine (MDMA) has shown efficacy in six phase 2 trials. Its cost-effectiveness is unknown.
METHODS AND FINDINGS


To assess the cost-effectiveness of MDMA-assisted psychotherapy (MAP) from the health care payer's perspective, we constructed a decision-analytic Markov model to portray the costs and health benefits of treating patients with chronic, severe, or extreme, treatment-resistant PTSD with MAP. In six double-blind phase 2 trials, MAP consisted of a mean of 2.5 90-minute trauma-focused psychotherapy sessions before two 8-hour sessions with MDMA (mean dose of 125 mg), followed by a mean of 3.5 integration sessions for each active session. The control group received an inactive placebo or 25-40 mg. of MDMA, and otherwise followed the same regimen. Our model calculates net medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. Efficacy was based on the pooled results of six randomized controlled phase 2 trials with 105 subjects; and a four-year follow-up of 19 subjects. Other inputs were based on published literature and on assumptions when data were unavailable. We modeled results over a 30-year analytic horizon and conducted extensive sensitivity analyses. Our model calculates expected medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio. Future costs and QALYs were discounted at 3% per year. For 1,000 individuals, MAP generates discounted net savings of $103.2 million over 30 years while accruing 5,553 discounted QALYs, compared to continued standard of care. MAP breaks even on cost at 3.1 years while delivering 918 QALYs. Making the conservative assumption that benefits cease after one year, MAP would accrue net costs of $7.6 million while generating 288 QALYS, or $26,427 per QALY gained.
CONCLUSION


MAP provided to patients with severe or extreme, chronic PTSD appears to be cost-saving while delivering substantial clinical benefit. Third-party payers are likely to save money within three years by covering this form of therapy.",2020,"Our model calculates net medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios.","['patients with chronic, severe, or extreme, treatment-resistant PTSD with MAP', 'Chronic posttraumatic stress disorder (PTSD', '105 subjects; and a four-year follow-up of 19 subjects']","['MDMA-assisted psychotherapy', '3,4-methylenedioxymethamphetamine', 'MDMA-assisted psychotherapy (MAP', 'inactive placebo']","['medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio', 'Efficacy', 'medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0115471', 'cui_str': 'Methylenedioxymethamphetamine'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0115471', 'cui_str': 'Methylenedioxymethamphetamine'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0346378,"Our model calculates net medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios.","[{'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Marseille', 'Affiliation': 'Health Strategies International, Oakland, California, United States of America.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kahn', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Berra', 'Initials': 'B', 'LastName': 'Yazar-Klosinski', 'Affiliation': 'Multidisciplinary Association for Psychedelic Studies (MAPS), Santa Cruz, California, United States of America.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Doblin', 'Affiliation': 'Multidisciplinary Association for Psychedelic Studies (MAPS), Santa Cruz, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0239997']
2503,33053005,Massage and Reiki to reduce stress and improve quality of life: a randomized clinical trial.,"OBJECTIVE


To verify if a Massage (Anma technique) followed by rest or Reiki helps to reduce stress levels and improve the quality of life of individuals seen in an outpatient clinic of integrative practices.
METHOD


A randomized controlled clinical trial conducted with 122 individuals randomized into three groups: G1 - Massage followed by rest; G2 - Massage followed by Reiki; and G3 - control (no intervention). Stress and Quality of Life levels were measured using the LSS and SF-12v2 instruments, which were applied before and after the intervention.
RESULTS


The study was conducted with 101 participants. Massages followed by rest (G1) or Reiki (G2) proved to be effective in reducing stress levels and improving quality of life when compared to the Control Group (G3). The best results obtained by the group which received Massage followed by Reiki (G2) were observed in the mental domain of quality of life, emphasizing the scope of Reiki effects on mental and psychological aspects.
CONCLUSION


Massage followed by rest and Massage followed by Reiki application were effective in reducing stress levels and improving quality of life. Brazilian Registry of Clinical Trials: RBR-42c8wp.",2020,Massages followed by rest (G1) or Reiki (G2) proved to be effective in reducing stress levels and improving quality of life when compared to the Control Group (G3).,"['101 participants', '122 individuals randomized into three groups']","['Massage followed by Reiki (G2', 'G1 - Massage followed by rest; G2 - Massage followed by Reiki; and G3 - control (no intervention', 'Massage followed by rest and Massage followed by Reiki application', 'Massage (Anma technique) followed by rest or Reiki', 'Massages followed by rest (G1) or Reiki (G2', 'Massage and Reiki']","['quality of life', 'Stress and Quality of Life levels', 'stress levels and improving quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0751715', 'cui_str': 'Reiki'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",122.0,0.0298056,Massages followed by rest (G1) or Reiki (G2) proved to be effective in reducing stress levels and improving quality of life when compared to the Control Group (G3).,"[{'ForeName': 'Leonice Fumiko Sato', 'Initials': 'LFS', 'LastName': 'Kurebayashi', 'Affiliation': 'Universidade de São Paulo, Escola de Enfermagem, Programa de Pós-Graduação em Enfermagem na Saúde do Adulto, São Paulo, SP, Brasil.'}, {'ForeName': 'Juliana Rizzo', 'Initials': 'JR', 'LastName': 'Gnatta', 'Affiliation': 'Universidade de São Paulo, Escola de Enfermagem, Departamento de Enfermagem Médico-Cirúrgica, São Paulo, SP, Brasil.'}, {'ForeName': 'Gisele', 'Initials': 'G', 'LastName': 'Kuba', 'Affiliation': 'Universidade de São Paulo, Escola de Enfermagem, Programa de Pós-Graduação em Enfermagem na Saúde do Adulto, São Paulo, SP, Brasil.'}, {'ForeName': 'Ana Lucia Lopes', 'Initials': 'ALL', 'LastName': 'Giaponesi', 'Affiliation': 'Universidade de São Paulo, Escola de Enfermagem, Programa de Pós-Graduação em Enfermagem na Saúde do Adulto, São Paulo, SP, Brasil.'}, {'ForeName': 'Talita Pavarini Borges de', 'Initials': 'TPB', 'LastName': 'Souza', 'Affiliation': 'Universidade de São Paulo, Escola de Enfermagem, Programa de Pós-Graduação em Enfermagem na Saúde do Adulto, São Paulo, SP, Brasil.'}, {'ForeName': 'Ruth Natalia Teresa', 'Initials': 'RNT', 'LastName': 'Turrini', 'Affiliation': 'Universidade de São Paulo, Escola de Enfermagem, Departamento de Enfermagem Médico-Cirúrgica, São Paulo, SP, Brasil.'}]",Revista da Escola de Enfermagem da U S P,['10.1590/S1980-220X2018059103612']
2504,33053010,The effect of operative groups on diabetic foot self-care education: a randomized clinical trial.,"OBJECTIVE


To evaluate the effect of operative groups on teaching self-care for diabetic foot prevention.
METHOD


Controlled, blinded clinical trial with volunteers presenting type 2 Diabetes Mellitus, randomized into treatment (55 subjects) and control (54 subjects) groups. The treatment group received the educational intervention ""Teaching foot self-care"", whereas the control group was simply evaluated. Feet evaluation was conducted before and after the intervention, as well as 15 days later in a follow-up. The intervention was conducted through an operative group and developed with orientation via writing, explained through dialogue and role-playing. The following tests were used: Shapiro-Wilk, Chi-squared, t-test, Mann-Whitney, McNemar, and paired Wilcoxon.
RESULTS


One-hundred and nine volunteers took part in this study. Their sociodemographic variables were homogeneous. In an analysis between groups, an improvement was observed after the educational intervention regarding most variables related to skin annexes, blood flow, foot sensitivity, and foot pressure. Improved scores for risk of diabetic foot in the treatment group were observed.
CONCLUSION


The educational intervention through operative group was efficient, for it encouraged self-care and reduced potential risk of diabetic foot. Brazilian Registry of Clinical Trials (Registro Brasileiro de Ensaios Clínicos): RBR- 753 Kcg.",2020,"In an analysis between groups, an improvement was observed after the educational intervention regarding most variables related to skin annexes, blood flow, foot sensitivity, and foot pressure.","['One-hundred and nine volunteers took part in this study', 'volunteers presenting type 2 Diabetes Mellitus, randomized into treatment (55 subjects) and control (54 subjects) groups']","['educational intervention ""Teaching foot self-care']","['diabetic foot self-care education', 'skin annexes, blood flow, foot sensitivity, and foot pressure', 'risk of diabetic foot']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}]","[{'cui': 'C0206172', 'cui_str': 'Diabetic foot'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",109.0,0.037237,"In an analysis between groups, an improvement was observed after the educational intervention regarding most variables related to skin annexes, blood flow, foot sensitivity, and foot pressure.","[{'ForeName': 'João Batista', 'Initials': 'JB', 'LastName': 'Moreira', 'Affiliation': 'Universidade Federal de Alfenas, Programa de Pós-Graduação em Enfermagem, Alfenas, MG, Brasil.'}, {'ForeName': 'Eliene Sousa', 'Initials': 'ES', 'LastName': 'Muro', 'Affiliation': 'Universidade Federal de Alfenas, Programa de Pós-Graduação em Enfermagem, Alfenas, MG, Brasil.'}, {'ForeName': 'Lidiane Aparecida', 'Initials': 'LA', 'LastName': 'Monteiro', 'Affiliation': 'Universidade de São Paulo, Escola de Enfermagem de Ribeirão Preto, Programa de Pós-Graduação em Enfermagem, Ribeirão Preto, SP, Brasil.'}, {'ForeName': 'Denise Hollanda', 'Initials': 'DH', 'LastName': 'Iunes', 'Affiliation': 'Universidade Federal de Alfenas, Instituto Ciências da Motricidade, Alfenas, MG, Brasil.'}, {'ForeName': 'Bianca Bacelar de', 'Initials': 'BB', 'LastName': 'Assis', 'Affiliation': 'Universidade Federal de Alfenas, Programa de Pós-Graduação em Enfermagem, Alfenas, MG, Brasil.'}, {'ForeName': 'Erika de Cássia Lopes', 'Initials': 'ECL', 'LastName': 'Chaves', 'Affiliation': 'Universidade Federal de Alfenas, Escola de Enfermagem, Alfenas, MG, Brasil.'}]",Revista da Escola de Enfermagem da U S P,['10.1590/S1980-220X2019005403624']
2505,33053024,COVID-19-associated ARDS treated with DEXamethasone (CoDEX): study design and rationale for a randomized trial.,"OBJECTIVE


The infection caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads worldwide and is considered a pandemic. The most common manifestation of SARS-CoV-2 infection (coronavirus disease 2019 - COVID-19) is viral pneumonia with varying degrees of respiratory compromise and up to 40% of hospitalized patients might develop acute respiratory distress syndrome. Several clinical trials evaluated the role of corticosteroids in non-COVID-19 acute respiratory distress syndrome with conflicting results. We designed a trial to evaluate the effectiveness of early intravenous dexamethasone administration on the number of days alive and free of mechanical ventilation within 28 days after randomization in adult patients with moderate or severe acute respiratory distress syndrome due to confirmed or probable COVID-19.
METHODS


This is a pragmatic, prospective, randomized, stratified, multicenter, open-label, controlled trial including 350 patients with early-onset (less than 48 hours before randomization) moderate or severe acute respiratory distress syndrome, defined by the Berlin criteria, due to COVID-19. Eligible patients will be randomly allocated to either standard treatment plus dexamethasone (Intervention Group) or standard treatment without dexamethasone (Control Group). Patients in the intervention group will receive dexamethasone 20mg intravenous once daily for 5 days, followed by dexamethasone 10mg IV once daily for additional 5 days or until intensive care unit discharge, whichever occurs first. The primary outcome is ventilator-free days within 28 days after randomization, defined as days alive and free from invasive mechanical ventilation. Secondary outcomes are all-cause mortality rates at day 28, evaluation of the clinical status at day 15 assessed with a 6-level ordinal scale, mechanical ventilation duration from randomization to day 28, Sequential Organ Failure Assessment Score evaluation at 48 hours, 72 hours and 7 days and intensive care unit -free days within 28.",2020,Eligible patients will be randomly allocated to either standard treatment plus dexamethasone (Intervention Group) or standard treatment without dexamethasone (Control Group).,"['Eligible patients', '350 patients with early-onset (less than 48 hours before randomization) moderate or severe acute respiratory distress syndrome, defined by the Berlin criteria, due to COVID-19', 'adult patients with moderate or severe acute respiratory distress syndrome due to confirmed or probable COVID-19']","['corticosteroids', 'DEXamethasone (CoDEX', 'dexamethasone', 'standard treatment plus dexamethasone (Intervention Group) or standard treatment without dexamethasone (Control Group']","['ventilator-free days within 28 days after randomization, defined as days alive and free from invasive mechanical ventilation', 'cause mortality rates at day 28, evaluation of the clinical status at day 15 assessed with a 6-level ordinal scale, mechanical ventilation duration from randomization to day 28, Sequential Organ Failure Assessment Score evaluation', 'number of days alive and free of mechanical ventilation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",350.0,0.244425,Eligible patients will be randomly allocated to either standard treatment plus dexamethasone (Intervention Group) or standard treatment without dexamethasone (Control Group).,"[{'ForeName': 'Bruno Martins', 'Initials': 'BM', 'LastName': 'Tomazini', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Israel Silva', 'Initials': 'IS', 'LastName': 'Maia', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Flavia Regina', 'Initials': 'FR', 'LastName': 'Bueno', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Maria Vitoria Aparecida Oliveira', 'Initials': 'MVAO', 'LastName': 'Silva', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Franca Pellison', 'Initials': 'FP', 'LastName': 'Baldassare', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Eduardo Leite Vieira', 'Initials': 'ELV', 'LastName': 'Costa', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Ricardo Antonio Bonifácio', 'Initials': 'RAB', 'LastName': 'Moura', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Michele Ouriques', 'Initials': 'MO', 'LastName': 'Honorato', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'André Nathan', 'Initials': 'AN', 'LastName': 'Costa', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Alexandre Biasi', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Regis Goulart', 'Initials': 'RG', 'LastName': 'Rosa', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Avezum', 'Affiliation': 'Hospital Alemão Oswaldo Cruz - São Paulo (SP), Brasil.'}, {'ForeName': 'Viviane Cordeiro', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'Hospital Beneficência Portuguesa - São Paulo (SP), Brasil.'}, {'ForeName': 'Renato Delascio', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Brazilian Clinical Research Institute (BCRI) - São Paulo (SP), Brasil.'}, {'ForeName': 'Lucas Petri', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Flávia Ribeiro', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Hospital Israelita Albert Einstein - São Paulo (SP), Brasil.'}, {'ForeName': 'Luciano César Pontes de', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Revista Brasileira de terapia intensiva,['10.5935/0103-507X.20200063']
2506,33053048,The effect of prophylactic rewarming on postoperative nausea and vomiting among patients undergoing laparoscopic hysterectomy: a prospective randomized clinical study.,"BACKGROUND


Postoperative nausea and vomiting (PONV) is a common complication from general anesthesia that impacts on postoperative recovery.
OBJECTIVE


To evaluate prophylactic rewarming following general anesthesia, so as to decrease the incidence of PONV among patients undergoing laparoscopic hysterectomy.
DESIGN AND SETTING


Prospective randomized clinical study at a hospital in China.
METHODS


Sixty-two patients were randomly assigned into two groups. The forced air warming (FAW) group received pre-warmed Ringer's solution with FAW until the end of surgery. The control group received Ringer's solution without FAW. The pre-warmed Ringer's solution was stored in a cabinet set at 40 °C. The FAW tube was placed beside the patient's shoulder with a temperature of 43 °C.
RESULTS


Sixty patients completed the study. The FAW group showed significant differences versus the controls regarding temperature. At 6, 24 and 48 hours postoperatively, the incidences of PONV were 53.3%, 6.7% and 3.3% in the FAW group versus 63.3%, 30% and 3.3% in the controls. VAS scores were significantly lower in the FAW group than in the controls at 24 hours (P= 0.035). Forty-item questionnaire total scores in the FAW group were significantly higher than in the controls. The physical independence and pain scores at 24 hours and emotional support and pain scores at 48 hours in the FAW group were higher than in the controls (P < 0.05). There was no difference in hemodynamics or demographics between the two groups (P > 0.05).
CONCLUSIONS


Prophylactic rewarming relieved PONV and improved the quality of postoperative recovery.
CHINESE CLINICAL TRIAL REGISTER (CHICTR)


ChiCTR-IOR-17012901.",2020,VAS scores were significantly lower in the FAW group than in the controls at 24 hours (P= 0.035).,"['patients undergoing laparoscopic hysterectomy', 'Sixty-two patients', 'Prospective randomized clinical study at a hospital in China', 'Sixty patients completed the study']","['prophylactic rewarming', ""forced air warming (FAW) group received pre-warmed Ringer's solution with FAW"", ""Ringer's solution without FAW"", 'FAW']","['VAS scores', 'postoperative nausea and vomiting', 'Forty-item questionnaire total scores', 'quality of postoperative recovery', 'hemodynamics or demographics', 'physical independence and pain scores at 24 hours and emotional support and pain scores', 'incidence of PONV', 'incidences of PONV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0206156', 'cui_str': 'Rewarming'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0073386', 'cui_str': 'Ringers Solution'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",62.0,0.0653324,VAS scores were significantly lower in the FAW group than in the controls at 24 hours (P= 0.035).,"[{'ForeName': 'DongDong', 'Initials': 'D', 'LastName': 'Liang', 'Affiliation': 'MD. Anesthesiologist, Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Ouhai Area, Wenzhou City, Zhejiang Province, China.'}, {'ForeName': 'YuanLu', 'Initials': 'Y', 'LastName': 'Shan', 'Affiliation': 'MD. Anesthesiologist, Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Ouhai Area, Wenzhou City, Zhejiang Province, China.'}, {'ForeName': 'Leilei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'MD. Anesthesiologist, Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Ouhai Area, Wenzhou City, Zhejiang Province, China.'}]",Sao Paulo medical journal = Revista paulista de medicina,['10.1590/1516-3180.2020.0059.R2.06072020']
2507,33053078,Effectiveness of ginger in reducing metabolic levels in people with diabetes: a randomized clinical trial.,"OBJECTIVE


to evaluate the effectiveness of ginge (Zingiber officinale) in reducing blood sugar and lipid levels in people with type 2 diabetes.
METHOD


a randomized and double-blind clinical trial conducted with people with type 2 diabetes in primary care facilities. The study included individuals aged between 20 and 80 years old, using oral antidiabetic drugs and with HbA1c levels between 6.0% and 10%. The participants were paired 1:1, allocated in two distinct groups, and randomized in blocks, based on their HbA1c levels. In the experimental group, the participants used 1.2g of ginger and, in the control group, 1.2g of placebo, daily for 90 days. The primary outcome was a reduction in fasting blood sugar and HbA1c, and the secondary outcome was a reduction in lipids and HOMA-IR. 103 individuals completed the study, 47 in the experimental group and 56 in the control group.
RESULTS


the participants in the experimental group showed a greater reduction in the blood glucose and total cholesterol values compared to the control group.
CONCLUSION


the use of ginger can help in the treatment of people with diabetes, and data support the inclusion of this herbal drug in the clinical practice of nurses. RBR-2rt2wy.",2020,"the participants in the experimental group showed a greater reduction in the blood glucose and total cholesterol values compared to the control group.
","['103 individuals completed the study, 47 in the experimental group and 56 in the control group', 'people with type 2 diabetes', 'people with type 2 diabetes in primary care facilities', 'individuals aged between 20 and 80 years old, using oral antidiabetic drugs and with HbA1c levels between 6.0% and 10', 'people with diabetes']","['placebo', 'ginger', 'ginge (Zingiber officinale']","['reduction in fasting blood sugar and HbA1c', 'blood glucose and total cholesterol values', 'lipids and HOMA-IR', 'blood sugar and lipid levels', 'metabolic levels']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0162751', 'cui_str': 'Ginger'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",103.0,0.172749,"the participants in the experimental group showed a greater reduction in the blood glucose and total cholesterol values compared to the control group.
","[{'ForeName': 'Gerdane Celene Nunes', 'Initials': 'GCN', 'LastName': 'Carvalho', 'Affiliation': 'Universidade Estadual do Piauí, Departamento de Enfermagem, Picos, PI, Brazil.'}, {'ForeName': 'José Claudio Garcia', 'Initials': 'JCG', 'LastName': 'Lira-Neto', 'Affiliation': 'Universidade Federal do Ceará, Departamento de Enfermagem, Fortaleza, CE, Brazil.'}, {'ForeName': 'Márcio Flávio Moura de', 'Initials': 'MFM', 'LastName': 'Araújo', 'Affiliation': 'Fundação Oswaldo Cruz, Saúde Pública, Eusébio, CE, Brazil.'}, {'ForeName': 'Roberto Wagner Júnior Freire de', 'Initials': 'RWJF', 'LastName': 'Freitas', 'Affiliation': 'Fundação Oswaldo Cruz, Saúde Pública, Eusébio, CE, Brazil.'}, {'ForeName': 'Maria Lúcia', 'Initials': 'ML', 'LastName': 'Zanetti', 'Affiliation': 'Universidade de São Paulo, Escola de Enfermagem de Ribeirão Preto, PAHO/WHO Collaborating Centre for Nursing Research Development, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Marta Maria Coelho', 'Initials': 'MMC', 'LastName': 'Damasceno', 'Affiliation': 'Universidade Federal do Ceará, Departamento de Enfermagem, Fortaleza, CE, Brazil.'}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.3870.3369']
2508,33047622,Is There Clinical Improvement Associated With Intradiscal Therapies? A Comparison Across Randomized Controlled Studies.,"STUDY DESIGN


Post hoc comparison using single-site data from 4 multicenter randomized controlled trials.
OBJECTIVES


Discogenic back pain is associated with significant morbidity and medical cost. Several terminated, unreported randomized controlled trials have studied the effect of intradiscal biologic injections. Here we report single-center outcomes from these trials to determine if there is clinical improvement associated with these intradiscal injections.
METHODS


Post hoc comparison was performed using single-site data from 4 similar multi-center randomized controlled trials. All trials evaluated an injectable therapy (growth factor, fibrin sealant, or stem cells) for symptomatic lumbar disc disease with near-identical inclusion and exclusion criteria. Demographics and patient reported outcomes were analyzed across treatment arms postinjection.
RESULTS


A total of 38 patients were treated with biologic agents and 12 were treated with control saline injections. There was a significant decrease in visual analogue score (VAS) pain for both the investigational and saline groups up to 12 months postinjection ( P  < .01). There was no significant difference in VAS scores between the saline and investigational groups at 12 months. Similarly, there was significant improvement in patient-reported disability scores in both the investigational and saline groups at all time points. There were no significant differences in disability score improvement between the saline and investigational treatment groups at 12 months postinjection.
CONCLUSIONS


A single-center analysis of 4 randomized controlled studies demonstrated no difference in outcomes between therapeutic intradiscal agents (growth factor, fibrin sealant, or stem cells) and control saline groups. In all groups, patient reported pain and disability scores decreased significantly. Future studies are needed to evaluate the therapeutic benefit of any intradiscal injections.",2020,There was a significant decrease in visual analogue score (VAS) pain for both the investigational and saline groups up to 12 months postinjection ( P  < .01).,"['38 patients were treated with', 'symptomatic lumbar disc disease with near-identical inclusion and exclusion criteria']","['biologic agents', 'injectable therapy (growth factor, fibrin sealant, or stem cells', 'therapeutic intradiscal agents (growth factor, fibrin sealant, or stem cells', 'control saline injections']","['disability score improvement', 'patient-reported disability scores', 'VAS scores', 'visual analogue score (VAS) pain', 'pain and disability scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0221775', 'cui_str': 'Lumbar Disc Disease'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0016004', 'cui_str': 'Autologous Fibrin Tissue Adhesive'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1512934', 'cui_str': 'Intradiscal route'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",38.0,0.275865,There was a significant decrease in visual analogue score (VAS) pain for both the investigational and saline groups up to 12 months postinjection ( P  < .01).,"[{'ForeName': 'Derek G', 'Initials': 'DG', 'LastName': 'Ju', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'Kanim', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Hyun W', 'Initials': 'HW', 'LastName': 'Bae', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}]",Global spine journal,['10.1177/2192568220963058']
2509,33047625,"Exercise and Cognitive Training Intervention Improves Self-Care, Quality of Life and Functional Capacity in Persons With Heart Failure.","This study evaluated a 12-week, home-based combined aerobic exercise (walking) and computerized cognitive training (EX/CCT) program on heart failure (HF) self-care behaviors (Self-care of HF Index [SCHFI]), disease specific quality of life (Kansas City Cardiomyopathy Questionnaire [KCCQ]), and functional capacity (6-minute walk distance) compared to exercise only (EX) or a usual care attention control (AC) stretching and flexibility program. Participants ( N  = 69) were older, predominately female (54%) and African American (55%). There was significant improvement in self-care management,  F (2, 13) = 5.7,  p  < .016; KCCQ physical limitation subscale,  F (2, 52) = 3.4,  p  < .039; and functional capacity (336 ± 18 vs 388 ± 20 m,  p  < .05) among the EX/CCT participants. The underlying mechanisms that EX and CCT targets and the optimal dose that leads to improved outcomes are needed to design effective interventions for this rapidly growing population.",2020,"There was significant improvement in self-care management,  F (2, 13) = 5.7,  ","['Participants ( N  = 69) were older, predominately female (54%) and African American (55', 'Persons With Heart Failure']","['exercise only (EX) or a usual care attention control (AC) stretching and flexibility program', 'Exercise and Cognitive Training Intervention', 'home-based combined aerobic exercise (walking) and computerized cognitive training (EX/CCT) program']","['Self-Care, Quality of Life and Functional Capacity', 'self-care management,  F', 'heart failure (HF) self-care behaviors (Self-care of HF Index [SCHFI]), disease specific quality of life (Kansas City Cardiomyopathy Questionnaire [KCCQ]), and functional capacity (6-minute walk distance', 'functional capacity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",69.0,0.0130434,"There was significant improvement in self-care management,  F (2, 13) = 5.7,  ","[{'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Gary', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Sudeshna', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Corwin', 'Affiliation': 'Columbia University, New York City, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Butts', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Miller', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Hepburn', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Drenna', 'Initials': 'D', 'LastName': 'Waldrop', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464820964338']
2510,33047653,An Intervention to Promote Adherence to Glasses Wearing Among Urban Public Elementary School Students: Associations With Classroom Behavior.,"Glasses wearing at school remains low even when glasses are provided. This study investigated whether a classroom intervention to promote glasses wearing was associated with increased glasses wearing and improved classroom behavior. A pretest, posttest design was implemented with 44 students in Grades 1-4 at an urban public elementary school. Over 5 weeks, teachers encouraged eyeglass wearing through a classroom tracker, verbal reminders, and incentives. Glasses wearing and student behavior were monitored using the Direct Behavior Rating Scale of academic engagement and behavior for 13 weeks, including 4 weeks before and after the intervention. Glasses wearing increased from 56% to 73% (95% confidence interval [CI] = [0.08, 0.26]) in the first 2 weeks of the intervention, but not after a spring recess. The intervention was associated with significantly improved academic engagement (4.31%, 95% CI [2.17, 6.45]), respect (3.55%, 95% CI [1.77, 5.34]), and disruption (-4.28%, 95% CI [-6.51, -2.06]) compared to baseline. Higher academic engagement and disruption persisted 4 weeks after the intervention ended. A classroom-based glasses tracking and incentive system is associated with improved eyeglass wearing and classroom behavior among elementary students. A longer term randomized trial is needed to confirm these promising results.",2020,"The intervention was associated with significantly improved academic engagement (4.31%, 95% CI [2.17, 6.45]), respect (3.55%, 95% CI [1.77, 5.34]), and disruption (-4.28%, 95% CI [-6.51, -2.06]) compared to baseline.","['44 students in Grades 1-4 at an urban public elementary school', 'elementary students', 'Urban Public Elementary School Students']",['classroom intervention'],"['academic engagement', 'Glasses wearing', 'Glasses wearing and student behavior', 'Direct Behavior Rating Scale of academic engagement and behavior', 'glasses wearing and improved classroom behavior', 'eyeglass wearing and classroom behavior']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0558172', 'cui_str': 'Wears glasses'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0475483', 'cui_str': 'Behavior rating scale'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]",,0.120132,"The intervention was associated with significantly improved academic engagement (4.31%, 95% CI [2.17, 6.45]), respect (3.55%, 95% CI [1.77, 5.34]), and disruption (-4.28%, 95% CI [-6.51, -2.06]) compared to baseline.","[{'ForeName': 'Tania M', 'Initials': 'TM', 'LastName': 'Haag', 'Affiliation': 'Division of General Pediatrics, 1500Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gabriela Calderon', 'Initials': 'GC', 'LastName': 'Velazquez', 'Affiliation': 'Rales Center for the Integration of Health and Education, 1500Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Tresa', 'Initials': 'T', 'LastName': 'Wiggins', 'Affiliation': 'Rales Center for the Integration of Health and Education, 1500Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Spin', 'Affiliation': 'Rales Center for the Integration of Health and Education, 1500Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'Johnson', 'Affiliation': 'Division of General Pediatrics, 1500Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Connor', 'Affiliation': 'Division of General Pediatrics, 1500Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",The Journal of school nursing : the official publication of the National Association of School Nurses,['10.1177/1059840520963647']
2511,33047657,It is possible to develop the professional values of nurses.,"BACKGROUND


The awareness and development of professional values affect the quality of nursing care. This study is the first interventional study conducted to develop the professional values of nurses in a clinical setting.
OBJECTIVES


The aim of this study is to determine the effect of a structured Professional Values Development Programme on the development of the professional values of nurses.
RESEARCH DESIGN


This study was a non-randomised controlled trial that measured with pre-test and post-test. Data were collected by using an Individual Identification Form and the Nurses' Professional Values Scale-Revised. The intervention group was involved in a 12-week programme. Participants in the control group received the programme after all data had been collected. Data collection for both groups was conducted at baseline and a 12-week follow-up. Expert opinions were evaluated by the Kendall Coefficient of Correlation test. Chi-square tests and  t -tests were used to evaluate group differences. This study was registered at ClinicalTrials.gov.
PARTICIPANTS AND RESEARCH CONTEXT


This study was conducted with 80 nurses (intervention group = 40, control group = 40). This study was conducted in paediatric clinics in two university hospitals in Turkey.
ETHICAL CONSIDERATIONS


In order to conduct this study, ethics committee approval was obtained. This study was performed according to the Helsinki Declaration. Participants were informed verbally and in writing, and informed consent was obtained by giving explanations.
FINDINGS


In the analysis, the two groups were similar in demographic variables. The only significant difference between the groups was between weekly working hours. Participants in the intervention group reported statistically significantly higher levels of professional values ( p =  0.001) than those in the control group.
DISCUSSIONS AND CONCLUSIONS


This study provides evidence of the positive effectiveness of the Professional Values Development Programme in the development of professional values of clinical nurses. It also demonstrated the feasibility of implementing the programme with clinical nurses.",2020,"Participants in the intervention group reported statistically significantly higher levels of professional values ( p =  0.001) than those in the control group.
","['paediatric clinics in two university hospitals in Turkey', '80 nurses (intervention group = 40, control group = 40']","['structured Professional Values Development Programme', 'Professional Values Development Programme']",['levels of professional values'],"[{'cui': 'C3839701', 'cui_str': 'Pediatric clinic'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",80.0,0.0438689,"Participants in the intervention group reported statistically significantly higher levels of professional values ( p =  0.001) than those in the control group.
","[{'ForeName': 'Ayla', 'Initials': 'A', 'LastName': 'Kaya', 'Affiliation': '37502Akdeniz University, Turkey.'}, {'ForeName': 'Ayşegül Işler', 'Initials': 'AI', 'LastName': 'Dalgiç', 'Affiliation': '37502Akdeniz University, Turkey.'}]",Nursing ethics,['10.1177/0969733020952135']
2512,33047687,Enhanced recovery after surgery in laparoscopic distal gastrectomy: Protocol for a prospective single-arm clinical trial.,"Background


The enhanced recovery after surgery (ERAS) programme is feasible and effective in reducing the length of hospital stay, overall complication rates and medical costs when applied to cases involving colonic and rectal resections. However, a recent prospective, randomised, open, parallel-controlled trial (Chinese Laparoscopic Gastrointestinal Surgery Study-01 trial), initiated by our team, indicated that under conventional peri-operative management, the reduction of the post-operative hospital stay of laparoscopic distal gastrectomy (LDG) is quite limited compared with open gastrectomy. Thus, if we could provide valuable clinical evidence for demonstrating the efficacy of the ERAS programme for gastric cancer patients undergoing LDG, it would significantly enhance the peri-operative management of gastrectomy and benefit the patients.
Methods


In this prospective single-arm trial, patients who are 18-75 years of age with gastric adenocarcinoma diagnosed with cT1-4aN0-3M0 and expected to undergo curative resection through LDG, are considered eligible for this study. All participants underwent LDG with peri-operative management under the ERAS programme. The primary outcome measures included the post-operative hospital stays and rehabilitative rate of the post-operative day 4. The secondary outcome measures are morbidity and mortality (time frame: 30 days), post-operative recovery index (time frame: 30 days), post-operative pain intensity (time frame: 3 days) and the medical costs from surgery to discharge.
Conclusion


With reasonable and scientific designing, the trial may be a great help to further discuss the benefit of ERAS programme and thus improving the peri-operative management of patients with gastrectomy.",2020,"The enhanced recovery after surgery (ERAS) programme is feasible and effective in reducing the length of hospital stay, overall complication rates and medical costs when applied to cases involving colonic and rectal resections.","['All participants underwent LDG with peri-operative management under the ERAS programme', 'gastric cancer patients undergoing LDG', 'patients with gastrectomy', 'patients who are 18-75 years of age with gastric adenocarcinoma diagnosed with cT1-4aN0-3M0 and expected to undergo curative resection through LDG, are considered eligible for this study']","['laparoscopic distal gastrectomy (LDG', 'ERAS programme', 'laparoscopic distal gastrectomy', 'surgery (ERAS) programme']","['morbidity and mortality (time frame: 30 days), post-operative recovery index (time frame: 30 days), post-operative pain intensity (time frame: 3 days) and the medical costs from surgery to discharge', 'post-operative hospital stays and rehabilitative rate of the post-operative day 4', 'length of hospital stay, overall complication rates and medical costs']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0278701', 'cui_str': 'Adenocarcinoma of stomach'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1438035', 'cui_str': 'SLC6A8 protein, human'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332168', 'cui_str': 'Time frame'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0800456,"The enhanced recovery after surgery (ERAS) programme is feasible and effective in reducing the length of hospital stay, overall complication rates and medical costs when applied to cases involving colonic and rectal resections.","[{'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Mingli', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yanfeng', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yuehong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Guoxin', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_35_19']
2513,33047859,"Safety, Pharmacokinetics and Pharmacodynamics of BI 655064 in Phase 1 Clinical Trials in Healthy Chinese and Japanese Subjects.","AIMS


To evaluate the safety, pharmacokinetics and pharmacodynamics of BI 655064 in healthy Chinese and Japanese subjects after administration of single doses of 80-240 mg and multiple dosing of 240 mg once weekly over 4 weeks.
METHODS


Two Phase 1, double-blind, placebo-controlled studies were conducted (single-rising doses of BI 655064 in Chinese/Japanese male subjects [n=12 per BI 655064 dose group] or repeated 240 mg BI 655064 in Chinese male subjects [n=9]). Plasma samples were collected to investigate BI 655064 pharmacokinetics, pharmacodynamics (CD40 receptor occupancy [RO]) and immunogenicity, along with safety and tolerability of BI 655064.
RESULTS


BI 655064 showed good overall tolerability following single-dose administration of 80-240 mg and repeated administration of 240 mg BI 655064 over 4 weeks. More Chinese subjects reported adverse events compared with Japanese subjects following single-dose administration (59.4% vs 3.1%). BI 655064 exhibited non-linear, saturable kinetics, with higher doses resulting in slower apparent clearance (0.514-0.713 mL min -1  ), and disproportionately higher total exposure (AUC 0-inf  ; 5610-7780 μg·h mL -1  ) and maximum plasma concentration (15,700-21,300 ng mL -1  ) with 240 mg BI 655064. Ninety percent inhibition of CD40 RO was achieved with doses ≥120 mg, and a direct relationship between BI 655064 plasma concentration and inhibition of CD40 RO was observed. Most subjects had a positive treatment-emergent anti-drug antibody response.
CONCLUSIONS


BI 655064 pharmacokinetic and safety profiles in East Asian male subjects were consistent with those observed in a Western population. No adjustments in the BI 655064 dosing recommendations are warranted for future clinical trials.",2020,"Ninety percent inhibition of CD40 RO was achieved with doses ≥120 mg, and a direct relationship between BI 655064 plasma concentration and inhibition of CD40 RO was observed.","['healthy Chinese and Japanese subjects', 'Healthy Chinese and Japanese Subjects', 'Chinese/Japanese male subjects [n=12 per BI 655064 dose group] or repeated 240 mg BI 655064 in Chinese male subjects [n=9', 'East Asian male subjects']",['placebo'],"['BI 655064 pharmacokinetics, pharmacodynamics (CD40 receptor occupancy [RO]) and immunogenicity, along with safety and tolerability', 'CD40 RO', 'maximum plasma concentration', 'adverse events', 'safety, pharmacokinetics and pharmacodynamics', 'Safety, Pharmacokinetics and Pharmacodynamics', 'good overall tolerability', 'BI 655064 plasma concentration and inhibition of CD40 RO']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4742301', 'cui_str': 'BI 655064'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4742301', 'cui_str': 'BI 655064'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0054959', 'cui_str': 'Lymphocyte antigen CD40'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",655064.0,0.0491252,"Ninety percent inhibition of CD40 RO was achieved with doses ≥120 mg, and a direct relationship between BI 655064 plasma concentration and inhibition of CD40 RO was observed.","[{'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Tsuda', 'Affiliation': 'Nippon Boehringer Ingelheim Co. Ltd., Kobe, Japan.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Grimaldi', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Ewald', 'Initials': 'E', 'LastName': 'Benediktus', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Yagi', 'Affiliation': 'Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Padula', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'In-Jin', 'Initials': 'IJ', 'LastName': 'Jang', 'Affiliation': 'Seoul National University Hospital Clinical Trials Center, Seoul, Korea.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Steffgen', 'Affiliation': 'Boehringer Ingelheim International GmbH, Biberach, Germany.'}]",British journal of clinical pharmacology,['10.1111/bcp.14601']
2514,33047896,Long-term prognosis of patients treated by coronary sinus-based percutaneous annuloplasty: single centre experience.,"AIMS


This study aims to report long-term mortality, echocardiographic, and clinical outcomes of patients receiving treatment for functional mitral regurgitation (FMR) with the Carillon device.
METHODS AND RESULTS


This was a single centre analysis of prospectively collected data from patients treated with the Carillon Mitral Contour System for symptomatic congestive heart failure despite guideline-directed medical therapy, who were included from a single centre from the TITAN II study. All patients presented with New York Heart Association (NYHA) class 2 or greater symptoms, grade 2+ to 4+ FMR, left ventricular enlargement, and reduced ejection fraction. Surviving patients were evaluated for long-term follow-up post-procedure, averaging 6.9 years. Fifteen (15) patients (mean age 72 years, 60% male, 100% NYHA class III or IV, 50% MR grade 3+ or 4+) were treated with the Carillon device. The Kaplan-Meier mortality rate was 40% at 6 years of follow-up. Long-term survival through 6 years was associated with echocardiographic improvement in mitral regurgitation (change in effective regurgitant orifice area in survivors versus non-survivors from baseline to 1 year follow-up, -9.0 ± 5.6 vs. -1.7 ± 1.5, P = 0.02) and clinical status at 12 months (difference in NYHA at 1 year follow-up between survivors versus non-survivors, P = 0. 05) which was sustained throughout follow-up. All patients at 6 year follow-up had ≤2+ MR, with 6 of 7 having 0-1+ MR. Left ventricular end-diastolic volume was reduced from 154.0 ± 65.7 mL at baseline to 104.5 ± 59.2 mL at 6 year follow-up, P = 0.03 in survivors with both measurements.
CONCLUSIONS


Among patients with congestive heart failure treated with the Carillon device, long-term survival is associated with favourable 1 year and sustained improvements in mitral regurgitation, left ventricular volume, ejection fraction, and clinical status.",2020,"Long-term survival through 6 years was associated with echocardiographic improvement in mitral regurgitation (change in effective regurgitant orifice area in survivors versus non-survivors from baseline to 1 year follow-up, -9.0 ± 5.6 vs. -1.7 ± 1.5, P = 0.02) and clinical status at 12 months (difference in NYHA at 1 year follow-up between survivors versus non-survivors, P = 0. 05) which was sustained throughout follow-up.","['patients receiving treatment for functional mitral regurgitation (FMR) with the Carillon device', 'patients with congestive heart failure treated with the', 'Fifteen (15) patients (mean age 72\xa0years, 60% male, 100% NYHA class III or IV, 50% MR grade 3+ or 4', 'All patients presented with New York Heart Association (NYHA) class 2 or greater symptoms, grade 2+ to 4+ FMR, left ventricular enlargement, and reduced ejection fraction', 'patients treated with the Carillon Mitral Contour System for symptomatic congestive heart failure despite guideline-directed medical therapy, who were included from a single centre from the TITAN II study']","['coronary sinus-based percutaneous annuloplasty', 'Carillon device']","['mitral regurgitation, left ventricular volume, ejection fraction, and clinical status', 'Kaplan-Meier mortality rate', 'echocardiographic improvement in mitral regurgitation', 'Left ventricular end-diastolic volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0340369', 'cui_str': 'Functional mitral regurgitation'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0149721', 'cui_str': 'Left ventricular hypertrophy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0742758', 'cui_str': 'Symptomatic congestive heart failure'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0242756', 'cui_str': 'Titan'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0456944', 'cui_str': 'Coronary sinus structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0190165', 'cui_str': 'Annuloplasty'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}]",,0.0787485,"Long-term survival through 6 years was associated with echocardiographic improvement in mitral regurgitation (change in effective regurgitant orifice area in survivors versus non-survivors from baseline to 1 year follow-up, -9.0 ± 5.6 vs. -1.7 ± 1.5, P = 0.02) and clinical status at 12 months (difference in NYHA at 1 year follow-up between survivors versus non-survivors, P = 0. 05) which was sustained throughout follow-up.","[{'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Lipiecki', 'Affiliation': 'Centre de Cardiologie Interventionnelle, Elsan, Pôle Santé République, 99, Avenue de la République, Clermont-Ferrand, France.'}, {'ForeName': 'Hicham', 'Initials': 'H', 'LastName': 'Fahrat', 'Affiliation': 'Centre de Cardiologie Interventionnelle, Elsan, Pôle Santé République, 99, Avenue de la République, Clermont-Ferrand, France.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Monzy', 'Affiliation': 'Centre de Cardiologie Interventionnelle, Elsan, Pôle Santé République, 99, Avenue de la République, Clermont-Ferrand, France.'}, {'ForeName': 'Nicolat', 'Initials': 'N', 'LastName': 'Caillot', 'Affiliation': 'Centre de Cardiologie Interventionnelle, Elsan, Pôle Santé République, 99, Avenue de la République, Clermont-Ferrand, France.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Siminiak', 'Affiliation': 'Poznan University of Medical Sciences, HCP Medical Center, Poznan, Poland.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Johnson', 'Affiliation': 'Cardiac Dimensions, Kirkland, WA, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Vogt', 'Affiliation': 'Cardiac Dimensions, Kirkland, WA, USA.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Stark', 'Affiliation': 'Cardiac Dimensions, Kirkland, WA, USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Goldberg', 'Affiliation': 'Cardiac Dimensions, Kirkland, WA, USA.'}]",ESC heart failure,['10.1002/ehf2.12955']
2515,33047919,Bipolar and monopolar transurethral resection of the prostate are equally effective and safe in this high quality randomized controled trial.,,2021,,[],['Bipolar and monopolar transurethral resection'],[],[],"[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",[],,0.0259024,,"[{'ForeName': 'Cristiano M', 'Initials': 'CM', 'LastName': 'Gomes', 'Affiliation': 'Divisão de Urologia do Departamento de Cirurgia da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brasil.'}, {'ForeName': 'Julyana K M', 'Initials': 'JKM', 'LastName': 'Moromizato', 'Affiliation': 'Divisão de Urologia do Departamento de Cirurgia da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brasil.'}, {'ForeName': 'Thulio B V', 'Initials': 'TBV', 'LastName': 'Brandão', 'Affiliation': 'Divisão de Urologia do Departamento de Cirurgia da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brasil.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2019.0766.1']
2516,33047918,"A prospective randomized study comparing bipolar plasmakinetic transurethral resection of the prostate and monopolar transurethral resection of the prostate for the treatment of Benign Prostatic Hyperplasia: efficacy, sexual function, Quality of Life, and complications.","OBJECTIVE


To generate high-quality data comparing the clinical efficacy and safety profile between monopolar transurethral resection of the prostate (M-TURP) and bipolar plasmakinetic resection of the prostate (PK-TURP) for benign prostatic hyperplasia (BPH).
MATERIALS AND METHODS


Prospective, randomized, single-blinded study conducted in a tertiary-care public institution (Dec/2014-Aug/2016).
INCLUSION CRITERIA


prostate of <80g in patients with drug-refractory lower urinary tract symptoms (LUTS), complications derived from BPH, or both.
EXCLUSION CRITERIA


a history of pelvic surgery/radiotherapy, neurogenic bladder dysfunction or documented/suspected prostate carcinoma. Treatment efficacy evaluated at 1, 3, 6 and 12 months. Efficacy outcomes: international prostate symptom score (IPSS), quality-of-life (QoL) score, international index of erectile function-5 (IIEF-5), maximum urinary flow rate (Qmax), postvoid residual urine (PVRU) volume, and prostate volume (PV). Complications and sequelae also assessed. Comparisons performed with parametric/non-parametric tests.
RESULTS


Out of the 100 hundred patients, 84 qualified for the analysis (45 M-TURP/39 PK-TURP). No significant differences found in baseline characteristics or operative data, except for a longer operative time in PK-TURP (MD:7.9min; 95%CI:0.13-15.74; p=0.04). No differences found in IPSS, Qmax or PVRU volume. QoL score at 12 months was higher in PK-TURP (MD:0,9points; 95%CI:0.18-1.64; p=0.01). No differences in sexual function, PV, complications or sequelae were found. This study is ""rigorous"" (Jadad-scale) and has a low risk of bias (Cochrane-Handbook).
CONCLUSIONS


Based on this controlled trial, there is not significant variation in effectiveness and safety between M-TURP and PK-TURP for the treatment of BPH. The small difference in QoL between PK-TURP and M-TURP at the one-year follow-up is not perceivable by the patients and, therefore, not clinically relevant.",2021,"The small difference in QoL between PK-TURP and M-TURP at the one-year follow-up is not perceivable by the patients and, therefore, not clinically relevant.","['benign prostatic hyperplasia (BPH', 'Benign Prostatic Hyperplasia', '100 hundred patients, 84 qualified for the analysis (45 M-TURP/39 PK-TURP', 'patients with drug-refractory lower urinary tract symptoms (LUTS), complications derived from BPH, or both', 'Prospective, randomized, single-blinded study conducted in a tertiary-care public institution (Dec/2014-Aug/2016']","['bipolar plasmakinetic transurethral resection of the prostate and monopolar transurethral resection', 'monopolar transurethral resection of the prostate (M-TURP) and bipolar plasmakinetic resection of the prostate (PK-TURP']","['IPSS, Qmax or PVRU volume', 'QoL score', 'sexual function, Quality of Life, and complications', 'sexual function, PV, complications or sequelae', 'Efficacy outcomes: international prostate symptom score (IPSS), quality-of-life (QoL) score, international index of erectile function-5 (IIEF-5), maximum urinary flow rate (Qmax), postvoid residual urine (PVRU) volume, and prostate volume (PV', 'longer operative time']","[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}]","[{'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0429774', 'cui_str': 'Residual urine volume'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate'}, {'cui': 'C0278024', 'cui_str': 'Residual urine'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",,0.0822206,"The small difference in QoL between PK-TURP and M-TURP at the one-year follow-up is not perceivable by the patients and, therefore, not clinically relevant.","[{'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Otaola-Arca', 'Affiliation': 'Department of Urology, Clínica Alemana, Santiago, Chile.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Álvarez-Ardura', 'Affiliation': 'Department of Urology, Hospital Universitario de Fuenlabrada, Madrid, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Molina-Escudero', 'Affiliation': 'Department of Urology, Hospital Universitario de Fuenlabrada, Madrid, Spain.'}, {'ForeName': 'Mario I', 'Initials': 'MI', 'LastName': 'Fernández', 'Affiliation': 'Department of Urology, Clínica Alemana, Santiago, Chile.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Páez-Borda', 'Affiliation': 'Department of Urology, Hospital Universitario de Fuenlabrada, Madrid, Spain.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2019.0766']
2517,33048053,Internet-Based Multimodal Pain Program With Telephone Support for Adults With Chronic Temporomandibular Disorder Pain: Randomized Controlled Pilot Trial.,"BACKGROUND


Chronic pain from temporomandibular disorders remains an undertreated condition with debate regarding the most effective treatment modalities.
OBJECTIVE


The aim of the study was to investigate the treatment effect of an internet-based multimodal pain program on chronic temporomandibular disorder pain and evaluate the feasibility of a larger randomized controlled trial.
METHODS


An unblinded randomized controlled pilot trial was conducted with 43 participants (34 females, 9 males; median age 27, IQR 23-37 years) with chronic temporomandibular pain. Participants were recruited within the Public Dental Health Service and randomized to intervention (n=20) or active control (n=23). The intervention comprised a dentist-assisted internet-based multimodal pain program with 7 modules based on cognitive behavior therapy and self-management principles. The control group received conventional occlusal splint therapy. Primary outcomes included characteristic pain intensity, pain-related disability, and jaw functional limitation. Secondary outcomes were depression, anxiety, catastrophizing, and stress. Outcomes were self-assessed through questionnaires sent by mail at 3 and 6 months after treatment start. Feasibility evaluation included testing the study protocol and estimation of recruitment and attrition rates in the current research setting.
RESULTS


Only 49% of participants (21/43) provided data at the 6-month follow-up (internet-based multimodal pain program: n=7; control: n=14). Of the 20 participants randomized to the internet-based multimodal pain program, 14 started treatment and 8 completed all 7 modules of the program. Between-group analysis showed no significant difference for any outcome measure at 3- or 6-month follow-up-characteristic pain intensity (3 months: P=.58; 6 months: P=.41), pain-related disability (3 months: P=.51; 6 months: P=.12), jaw functional limitation (3 months: P=.45; 6 months: P=.90), degree of depression (3 months: P=.64; 6 months: P=.65), anxiety (3 months: P=.93; 6 months: P=.31), stress (3 months: P=.66; 6 months: P=.74), or catastrophizing (3 months: P=.86; 6 months: P=.85). Within-group analysis in the internet-based multimodal pain program group showed a significant reduction in jaw functional limitation score at the 6-month follow-up compared to baseline (Friedman: χ2=10.2, P=.04; Wilcoxon: z=-2.3, P=.02). In the occlusal splint group, jaw function limitation was also reduced at the 6-month follow-up (Friedman: χ2=20.0, P=.045; Wilcoxon: z=-2.3, P=.02), and there was a reduction in characteristic pain intensity at the 3- and 6-month follow-up (Friedman: χ2=25.1, P=.01; Wilcoxon 3 months: z=-3.0, P=.003; Wilcoxon 6 months: z=-3.3, P=.001).
CONCLUSIONS


This study was not able to demonstrate a difference in treatment outcome between an internet-based multimodal pain program and occlusal splint therapy in patients with chronic temporomandibular pain. However, the findings suggested that the internet-based multimodal pain program improves jaw function. The results also confirmed the treatment effect of occlusal splint therapy for chronic temporomandibular pain. Furthermore, because of the high attrition rate, this pilot study showed that a randomized controlled trial with this design is not feasible.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04363762; https://clinicaltrials.gov/show/NCT04363762.",2020,Between-group analysis showed no significant difference for any outcome measure at,"['43 participants (34 females, 9 males; median age 27, IQR 23-37 years) with chronic temporomandibular pain', 'Participants were recruited within the Public Dental Health Service and randomized to intervention (n=20) or active control (n=23', 'Adults With Chronic Temporomandibular Disorder Pain', 'patients with chronic temporomandibular pain', 'chronic temporomandibular pain']","['dentist-assisted internet-based multimodal pain program with 7 modules based on cognitive behavior therapy and self-management principles', 'Internet-Based Multimodal Pain Program With Telephone Support', 'occlusal splint therapy', 'internet-based multimodal pain program and occlusal splint therapy', 'conventional occlusal splint therapy', 'internet-based multimodal pain program']","['characteristic pain intensity', 'jaw functional limitation score', 'chronic temporomandibular disorder pain', 'pain-related disability', 'characteristic pain intensity, pain-related disability, and jaw functional limitation', 'degree of depression', 'jaw function limitation', 'anxiety', 'depression, anxiety, catastrophizing, and stress']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",20.0,0.131671,Between-group analysis showed no significant difference for any outcome measure at,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lam', 'Affiliation': 'Department of Orofacial Pain and Jaw Function, Faculty of Odontology, Malmö, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': 'Department of Orofacial Pain and Jaw Function, Faculty of Odontology, Malmö, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Alstergren', 'Affiliation': 'Department of Orofacial Pain and Jaw Function, Faculty of Odontology, Malmö, Sweden.'}]",Journal of medical Internet research,['10.2196/22326']
2518,33048056,"Effects of Acute Exercise on Drug Craving, Self-Esteem, Mood, and Affect in Adults with Polysubstance Use Disorder: Protocol for a Multicenter Randomized Controlled Trial.","BACKGROUND


Novel treatments for substance use disorders are needed. Acute bouts of exercise can improve mood states and craving in nonclinical populations. Exercise effects in those with polysubstance dependence are understudied; controlled trials are needed.
OBJECTIVE


This protocol describes a clinical study examining the short-term psychological effects of 2 types of physical activity, soccer and circuit training, in patients with substance use disorders. Effects will be compared with a nonexercise control group. Specific aims are to investigate whether there are differences between the activities and the duration of changes.
METHODS


This study is a short-term multicenter randomized control trial with a crossover design. Patients consecutively admitted to 4 inpatient treatment centers were invited to participate in 3 conditions, each lasting 45 minutes, within one week. The order of the conditions was randomized. There were a total of 5 assessments, taken at baseline, immediately before each condition, immediately after each condition, and 1, 2, and 4 hours postintervention, enabling patterns of change over time to be observed. Psychological effects were assessed with self-report questionnaires, which included scales for craving, state anxiety, positive and negative affect, self-esteem, and mood. Exercise intensity was assessed with the Borg Rating of Perceived Exertion scale and a heart rate monitor (Polar M200; Polar Electro Ltd). Cortisol was assessed in saliva before and 4 hours after the intervention.
RESULTS


A total of 39 patients were included in the study. Data collection was completed in 2019.
CONCLUSIONS


We anticipate larger improvements in the intervention groups than among controls, indicating positive psychological effects during and after exercise. The study will add clinically relevant information about the short-term psychological effects of exercise in the treatment of substance use disorders, using activities that are easily accessible in different clinical settings.
TRIAL REGISTRATION


German Clinical Trials Register DRKS00018869; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00018869.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18553.",2020,"Psychological effects were assessed with self-report questionnaires, which included scales for craving, state anxiety, positive and negative affect, self-esteem, and mood.","['Patients consecutively admitted to 4 inpatient treatment centers', 'A total of 39 patients were included in the study', 'Adults with Polysubstance Use Disorder', 'patients with substance use disorders', 'nonclinical populations']","['physical activity, soccer and circuit training', 'Acute Exercise']","['Cortisol', 'Exercise intensity', 'Drug Craving, Self-Esteem, Mood', 'Exercise effects', 'Psychological effects', 'self-report questionnaires, which included scales for craving, state anxiety, positive and negative affect, self-esteem, and mood', 'Borg Rating of Perceived Exertion scale and a heart rate monitor (Polar M200; Polar Electro Ltd']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0556446', 'cui_str': 'Craves for drugs'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C1136140', 'cui_str': 'Long-Term Depression, Neurophysiologic'}]",39.0,0.188736,"Psychological effects were assessed with self-report questionnaires, which included scales for craving, state anxiety, positive and negative affect, self-esteem, and mood.","[{'ForeName': 'Maren Mikkelsen', 'Initials': 'MM', 'LastName': 'Ellingsen', 'Affiliation': 'Department for Inpatient Treatment of Substance Misuse, Division of Mental Health and Addiction, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Sunniva Launes', 'Initials': 'SL', 'LastName': 'Johannesen', 'Affiliation': 'Department for Inpatient Treatment of Substance Misuse, Division of Mental Health and Addiction, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Egil Wilhelm', 'Initials': 'EW', 'LastName': 'Martinsen', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Sandra Rinne', 'Initials': 'SR', 'LastName': 'Dahl', 'Affiliation': 'Hormone Laboratory, Department of Medical Biochemistry, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hallgren', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}]",JMIR research protocols,['10.2196/18553']
2519,33048057,Impact of Remote Titration Combined With Telemonitoring on the Optimization of Guideline-Directed Medical Therapy for Patients With Heart Failure: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Guideline-directed medical therapy (GDMT), optimized to maximum tolerated doses, has been shown to improve clinical outcomes in patients with heart failure (HF). Timely use and optimization of GDMT can improve HF symptoms, reduce the burden of hospitalization, and increase survival rates, whereas GDMT deferral may worsen the progression of HF, decrease survival rates, and predispose patients to poor outcomes. However, studies indicate that GDMT remains underused, with less than 25% of patients receiving target doses in clinical practice. Telemonitoring is a potential component in the management of HF that can provide reliable and real-time physiological data for clinical decision support and facilitate remote titration of medication.
OBJECTIVE


The primary objective of this study is to evaluate the impact of remote titration facilitated by telemonitoring on health care outcomes, with a primary outcome measure being the proportion of patients achieving target doses. The secondary objective is to identify the barriers and facilitators that can affect the implementation and effectiveness of the intervention.
METHODS


A mixed methods study of a smartphone-based telemonitoring system is being conducted at the Peter Munk Cardiac Centre (PMCC), University Health Network, Toronto. The study is based on an effectiveness-implementation hybrid design and incorporates process evaluations alongside the assessment of clinical outcomes. The effectiveness research component is assessed by a two-arm randomized controlled trial (RCT) aiming to enroll 108 patients. The RCT compares a remote titration strategy that uses data from a smartphone-based telemonitoring system with a standard titration program consisting of in-office visits. The implementation research component consists of a qualitative study based on semistructured interviews with a purposive sample of clinicians and patients.
RESULTS


Patient recruitment began in January 2019 at PMCC, with a total of 76 participants recruited by February 24, 2020 (39 in the intervention group and 37 in the control group). The final analysis is expected to be completed by the winter of 2021.
CONCLUSIONS


This study will be among the first to provide evidence on the implementation of remote titration facilitated by telemonitoring and its impact on patient health outcomes. The successful use of telemonitoring for this purpose has the potential to alter the existing approach to titration of HF medication and support the development of a care delivery model that combines clinic visits with virtual follow-ups.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04205513; https://clinicaltrials.gov/ct2/show/NCT04205513.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/19705.",2020,"Telemonitoring is a potential component in the management of HF that can provide reliable and real-time physiological data for clinical decision support and facilitate remote titration of medication.
","['patients with heart failure (HF', 'Patients With Heart Failure', 'semistructured interviews with a purposive sample of clinicians and patients', 'Patient recruitment began in January 2019 at PMCC, with a total of 76 participants recruited by February 24, 2020 (39 in the intervention group and 37 in the control group', 'enroll 108 patients']","['GDMT', 'Remote Titration Combined With Telemonitoring', 'Guideline-directed medical therapy (GDMT', 'smartphone-based telemonitoring system']","['survival rates', 'burden of hospitalization, and increase survival rates', 'health care outcomes', 'HF symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0242800', 'cui_str': 'Patient Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",76.0,0.114959,"Telemonitoring is a potential component in the management of HF that can provide reliable and real-time physiological data for clinical decision support and facilitate remote titration of medication.
","[{'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Artanian', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Valeria E', 'Initials': 'VE', 'LastName': 'Rac', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ross', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Seto', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}]",JMIR research protocols,['10.2196/19705']
2520,33048059,AQUEDUCT Intervention for Crisis Team Quality and Effectiveness in Dementia: Protocol for a Feasibility Study.,"BACKGROUND


Specialist community teams often support people with dementia who experience crisis. These teams may vary in composition and models of practice, which presents challenges when evaluating their effectiveness. A best practice model for dementia crisis services could be used by teams to improve the quality and effectiveness of the care they deliver.
OBJECTIVE


The aim of this study is to examine the feasibility of conducting a large-scale randomized controlled trial comparing the AQUEDUCT (Achieving Quality and Effectiveness in Dementia Using Crisis Teams) Resource Kit intervention to treatment as usual.
METHODS


This is a multisite feasibility study in preparation for a future randomized controlled trial. Up to 54 people with dementia (and their carers) and 40 practitioners will be recruited from 4 geographically widespread teams managing crisis in dementia. Quantitative outcomes will be recorded at baseline and at discharge. This study will also involve a nested health economic substudy and qualitative research to examine participant experiences of the intervention and acceptability of research procedures.
RESULTS


Ethical approval for this study was granted in July 2019. Participant recruitment began in September 2019, and as of September 2020, all data collection has been completed. Results of this study will establish the acceptability of the intervention, recruitment rates, and will assess the feasibility and appropriateness of the outcome measures in preparation for a large-scale randomized controlled trial.
CONCLUSIONS


There is a need to evaluate the effectiveness of crisis intervention teams for older people with dementia. This is the first study to test the feasibility of an evidence-based best practice model for teams managing crisis in dementia. The results of this study will assist in the planning and delivery of a large-scale randomized controlled trial.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18971.",2020,This is the first study to test the feasibility of an evidence-based best practice model for teams managing crisis in dementia.,"['54 people with dementia (and their carers) and 40 practitioners will be recruited from 4 geographically widespread teams managing crisis in dementia', 'teams managing crisis in dementia', 'people with dementia who experience crisis', 'Dementia', 'older people with dementia', 'Using Crisis Teams']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],[],,0.127553,This is the first study to test the feasibility of an evidence-based best practice model for teams managing crisis in dementia.,"[{'ForeName': 'Emma Elizabeth', 'Initials': 'EE', 'LastName': 'Broome', 'Affiliation': 'National Institute for Health Research Nottingham Biomedical Research Centre, Hearing Sciences, Division of Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Donna Maria', 'Initials': 'DM', 'LastName': 'Coleston-Shields', 'Affiliation': 'Division of Psychiatry & Applied Psychology, Institute of Mental Health, School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Dening', 'Affiliation': 'Division of Psychiatry & Applied Psychology, Institute of Mental Health, School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Esme', 'Initials': 'E', 'LastName': 'Moniz-Cook', 'Affiliation': 'Faculty of Health Sciences, University of Hull, Hull, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Poland', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Stanyon', 'Affiliation': 'Division of Psychiatry & Applied Psychology, Institute of Mental Health, School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Orrell', 'Affiliation': 'Division of Psychiatry & Applied Psychology, Institute of Mental Health, School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}]",JMIR research protocols,['10.2196/18971']
2521,33048203,"The long-acting C5 inhibitor, ravulizumab, is efficacious and safe in pediatric patients with atypical hemolytic uremic syndrome previously treated with eculizumab.","BACKGROUND


Atypical hemolytic uremic syndrome (aHUS) is a rare, complement-mediated disease associated with poor outcomes if untreated. Ravulizumab, a long-acting C5 inhibitor developed through minimal, targeted modifications to eculizumab was recently approved for the treatment of aHUS. Here, we report outcomes from a pediatric patient cohort from the ravulizumab clinical trial (NCT03131219) who were switched from chronic eculizumab to ravulizumab treatment.
METHODS


Ten patients received a loading dose of ravulizumab on Day 1, followed by maintenance doses administered initially on Day 15, and then, every 4-8 weeks thereafter, depending on body weight. All patients completed the initial evaluation period of 26 weeks and entered the extension period.
RESULTS


No patients required dialysis at any point throughout the study. The median estimated glomerular filtration rate values remained stable during the trial: 99.8 mL/min/1.73m 2  at baseline, 93.5 mL/min/1.73m 2  at 26 weeks, and 104 mL/min/1.73m 2  at 52 weeks. At last available follow-up, all patients were in the same chronic kidney disease stage as recorded at baseline. Hematologic variables (platelets, lactate dehydrogenase, and hemoglobin) also remained stable throughout the initial evaluation period and up to the last available follow-up. All patients experienced adverse events; the most common were upper respiratory tract infection (40%) and oropharyngeal pain (30%). There were no meningococcal infections reported, no deaths occurred, and no patients discontinued during the study.
CONCLUSIONS


Overall, treatment with ravulizumab in pediatric patients with aHUS who were previously treated with eculizumab resulted in stable kidney and hematologic parameters, with no unexpected safety concerns when administered every 4-8 weeks.
TRIAL REGISTRATION


Trial identifiers: Trial ID: ALXN1210-aHUS-312 Clinical trials.gov : NCT03131219 EudraCT number: 2016-002499-29 Graphical abstract.",2020,"The median estimated glomerular filtration rate values remained stable during the trial: 99.8 mL/min/1.73m 2  at baseline, 93.5 mL/min/1.73m 2  at 26 weeks, and 104 mL/min/1.73m 2  at 52 weeks.","['pediatric patient cohort from the ravulizumab clinical trial (NCT03131219) who were switched from chronic eculizumab to ravulizumab treatment', 'pediatric patients with aHUS', 'Ten patients received a', 'pediatric patients with atypical hemolytic uremic syndrome']","['eculizumab', 'ravulizumab', 'loading dose of ravulizumab', 'Ravulizumab']","['deaths', 'adverse events', 'oropharyngeal pain', 'median estimated glomerular filtration rate values', 'Hematologic variables (platelets, lactate dehydrogenase, and hemoglobin', 'stable kidney and hematologic parameters']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4550350', 'cui_str': 'ravulizumab'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2931788', 'cui_str': 'Atypical haemolytic uraemic syndrome'}]","[{'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C4550350', 'cui_str': 'ravulizumab'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2363731', 'cui_str': 'Oropharyngeal pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0523617,"The median estimated glomerular filtration rate values remained stable during the trial: 99.8 mL/min/1.73m 2  at baseline, 93.5 mL/min/1.73m 2  at 26 weeks, and 104 mL/min/1.73m 2  at 52 weeks.","[{'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': ""Department of Nephrology, Aichi Children's Health and Medical Center, 7-426, Morioka-cho, Obu City, Aichi prefecture, 474-8710, Japan. kazuki.tanaka0505@gmail.com.""}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Adams', 'Affiliation': ""Department of Pediatric Nephrology, Children's Hospital Queen Fabiola, Université libre de Bruxelles, Brussels, Belgium.""}, {'ForeName': 'Alvaro Madrid', 'Initials': 'AM', 'LastName': 'Aris', 'Affiliation': ""Children's Nephrology and Renal Transplantation Service, Children's Maternity Hospital Sant Joan de Déu, University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Fujita', 'Affiliation': ""Department of Nephrology, Aichi Children's Health and Medical Center, 7-426, Morioka-cho, Obu City, Aichi prefecture, 474-8710, Japan.""}, {'ForeName': 'Masayo', 'Initials': 'M', 'LastName': 'Ogawa', 'Affiliation': 'Alexion Pharmaceuticals Inc, Boston, MA, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ortiz', 'Affiliation': 'Alexion Pharmaceuticals Inc, Boston, MA, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Vallee', 'Affiliation': 'Alexion Pharmaceuticals Inc, Boston, MA, USA.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Greenbaum', 'Affiliation': ""Division of Pediatric Nephrology, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA, USA.""}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-020-04774-2']
2522,33048260,"Effect of systemic antibiotics on the outcomes of regenerative periodontal surgery in intrabony defects: a randomized, controlled, clinical study.","OBJECTIVES


To assess the potential influence of systemic antibiotic administration on the healing of periodontal intrabony defects treated with deproteinized bovine bone mineral (DBBM) and collagen membrane.
MATERIALS AND METHODS


Forty-one intrabony defects were treated by means of DBBM and collagen membrane (GTR). Postoperatively, the patients received either systemic antibiotics (i.e., 1 g of amoxicillin, twice daily for 7 days) (test) or no antibiotics (control). Clinical attachment level (CAL), probing depth (PD), and gingival recession (GR) were measured at baseline and at 1 year following regenerative surgery. The depth of the intrabony component (INTRA DD) and its width (INTRA DW) were measured during surgery and after 1 year at reentry. The depth (RxD) and width (RxW) of the intrabony defects were evaluated radiographically at baseline and at 1 year.
RESULTS


No adverse events were observed in any of the two groups throughout the entire study period. In the test group, mean CAL changed from 8.7 ± 1.4 mm at baseline to 5.0 ± 1.7 mm at 1 year (p < 0.0001), while PD decreased from 7.8 ± 1.5 mm at baseline to 4.0 ± 0.9 mm at 1 year (p < 0.0001). In the control group, mean CAL changed from 8.6 ± 1.9 mm to 5.9 ± 1.6 mm (p < 0.001) and mean PD improved from 7.4 ± 1.3 mm to 4.1 ± 1.3 mm (p < 0.001). Mean CAL gain measured 3.6 ± 1.6 mm in the test and 2.7 ± 1.6 mm in the control group, respectively. Defect fill (i.e., INTRA DD gain) at re-entry measured 3.7 ± 1.8 mm in the test and 2.7 ± 2.1 mm in the control group. A CAL gain of ≥ 3 mm was measured in 76% of the defects in the test group and in 40% of the defects in the control group, respectively. In both groups, all evaluated clinical and radiographic parameters improved statistically significantly compared with baseline, but no statistically significant differences were found between the two groups.
CONCLUSIONS


Within their limits, the present study has failed to show any substantial added clinical benefits following the postoperative administration of amoxicillin in conjunction with regenerative periodontal surgery using DBBM and GTR.
CLINICAL RELEVANCE


The post-surgically administration of systemic antibiotics does not seem to be necessary following regenerative periodontal surgery.",2020,"In both groups, all evaluated clinical and radiographic parameters improved statistically significantly compared with baseline, but no statistically significant differences were found between the two groups.
","['intrabony defects', 'Forty-one intrabony defects']","['systemic antibiotics', 'amoxicillin', 'amoxicillin, twice daily for 7\xa0days) (test) or no antibiotics (control', 'deproteinized bovine bone mineral (DBBM', 'DBBM and collagen membrane (GTR']","['Mean CAL gain', 'Defect fill (i.e., INTRA DD gain', 'PD', 'adverse events', 'mean CAL', 'mean PD', 'depth (RxD) and width (RxW) of the intrabony defects', 'depth of the intrabony component (INTRA DD) and its width (INTRA DW', 'clinical and radiographic parameters', 'Clinical attachment level (CAL), probing depth (PD), and gingival recession (GR']","[{'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}]",,0.134113,"In both groups, all evaluated clinical and radiographic parameters improved statistically significantly compared with baseline, but no statistically significant differences were found between the two groups.
","[{'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Pietruska', 'Affiliation': 'Department of Periodontal and Oral Mucosa Diseases, Medical University of Bialystok, ul.Waszyngtona 13, 15-269, Bialystok, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Dolińska', 'Affiliation': 'Department of Periodontal and Oral Mucosa Diseases, Medical University of Bialystok, ul.Waszyngtona 13, 15-269, Bialystok, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Milewski', 'Affiliation': 'Department of Statistics and Medical Informatics, Medical University of Bialystok, ul.Szpitalna 37, 15-295, Bialystok, Poland.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Sculean', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Freiburgstrasse 7, 3010, Bern, Switzerland. anton.sculean@zmk.unibe.ch.'}]",Clinical oral investigations,['10.1007/s00784-020-03616-7']
2523,33048267,Negative Life Events as Predictors of Anxiety Outcomes: An Examination of Event Type.,"Long-term follow-up studies of anxiety treatment have found that greater exposure to negative life events (NLEs) predicts poorer anxiety outcomes, but none have examined whether specific types of NLEs are differentially associated with child outcomes. This study examined the frequency of NLEs and whether specific types of NLEs were associated with increased risk of having an anxiety disorder 6.5 years post randomization. Participants were 319 adolescents and adults, ages 11 to 26 (M = 17), enrolled in Child/Adolescent Anxiety Multimodal Extended Long-term Study. At their first follow-up visit, participants completed a diagnostic interview and a 40-item Life Events Scale that reflected whether specific events occurred since their last post treatment assessment. Life events were categorized into domains (i.e., family, academic, health, and social) via researcher consensus. Participants reported having experienced an average of four NLEs. Participants with an anxiety disorder at follow-up were significantly more likely to have failed a grade in school (OR = 5.9) and experienced a negative change in acceptance by peers (OR = 4.9; ps < 0.001). After controlling for gender, age, race, and SES, a greater number of NLEs in the academic domain increased the odds of having an anxiety disorder at follow-up (OR = 2.4, p < 0.001). No other domains were predictive of disorder status at follow-up. Findings highlight the value of examining specific NLEs in relation to the long-term child anxiety outcomes.",2020,"After controlling for gender, age, race, and SES, a greater number of NLEs in the academic domain increased the odds of having an anxiety disorder at follow-up (OR = 2.4, p < 0.001).","['M\u2009=\u200917), enrolled in Child/Adolescent Anxiety', 'Participants were 319 adolescents and adults, ages 11 to 26']",[],"['odds of having an anxiety disorder', 'Anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",319.0,0.0272756,"After controlling for gender, age, race, and SES, a greater number of NLEs in the academic domain increased the odds of having an anxiety disorder at follow-up (OR = 2.4, p < 0.001).","[{'ForeName': 'Elizabeth P', 'Initials': 'EP', 'LastName': 'Casline', 'Affiliation': 'Department of Psychology, University of Miami, Coral Gables, FL, USA.'}, {'ForeName': 'Golda S', 'Initials': 'GS', 'LastName': 'Ginsburg', 'Affiliation': 'Department of Psychiatry, University of Connecticut School of Medicine, Farmington, CT, USA. gginsburg@uchc.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Division of Child and Adolescent Psychiatry, UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, CA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Compton', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Kendall', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-020-00711-x']
2524,33048289,Impact of hemodialysis on clinical and angiographic outcomes in in-stent restenotic lesions following optical coherence tomography-guided drug-coated balloon treatment.,"Hemodialysis (HD) is associated with a high in-stent restenosis (ISR) rate even in the second-generation era. Drug-coated balloons (DCB) generally provide excellent clinical outcomes in patients with ISR lesions. Nonetheless, safety and efficacy of DCB for ISR lesions in HD patients are largely unknown. A total of 17 centers across Japan participated in this study. Patients were eligible for the study if ISR lesions were treated with DCB. Enrolled patients were divided into 2 groups (HD and non-HD groups). Angiographic, OCT, and clinical outcomes were compared between the HD and the non-HD groups. A total of 210 patients were enrolled (36 patients in the HD group, and 174 patients in the non-HD group). At 8 months, the binary restenosis rate was significantly higher (26.3% versus 11.3%, p = 0.02) and in-segment late loss was significantly higher (0.49 ± 0.61 mm versus 0.23 ± 0.33 mm, p = 0.02) in the HD group than the non-HD group. In the OCT analyses, change of minimum stent area between post- and pre-procedure was significantly smaller in the HD group compared to the non-HD group (0.08 ± 0.95 mm 2  versus 0.68 ± 1.07 mm 2 , p = 0.004). Target vessel failure (TVF) rate at 2 years was significantly different between the 2 groups (25.0% in the HD group and 12.1% in the non-HD group, p = 0.04). In the multivariate analysis, HD was a significant predictor for TVF (Hazard ratio 5.81, 95% CI 1.28-26.4, p = 0.02). Clinical and angiographic outcomes following OCT-guided DCB treatment in ISR lesions were significantly worse in HD patients compared to non-HD patients.Clinical Trial Registration Information: https://clinicaltrials.gov/ct2/show/NCT02300454.",2020,"In the multivariate analysis, HD was a significant predictor for TVF (Hazard ratio 5.81, 95% CI 1.28-26.4, p = 0.02).","['210 patients were enrolled (36 patients in the HD group, and 174 patients in the non-HD group', 'HD patients', 'A total of 17 centers across Japan participated in this study', 'patients with ISR lesions']","['DCB', 'OCT-guided DCB', 'Drug-coated balloons (DCB', 'optical coherence tomography-guided drug-coated balloon treatment']","['TVF', 'change of minimum stent area', 'segment late loss', 'ISR lesions', 'Angiographic, OCT, and clinical outcomes', 'binary restenosis rate', 'Target vessel failure (TVF) rate']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3272317', 'cui_str': 'Stent restenosis'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C3272317', 'cui_str': 'Stent restenosis'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",210.0,0.0335091,"In the multivariate analysis, HD was a significant predictor for TVF (Hazard ratio 5.81, 95% CI 1.28-26.4, p = 0.02).","[{'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Aoki', 'Affiliation': 'Division of Cardiology, Mitsui Memorial Hospital, 1 Kanda-Izumicho, Chiyoda-ku, Tokyo, 101-8643, Japan. aokijiro@gmail.com.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Nakazawa', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Kindai University, Osaka, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Department of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Cardiovascular Center, Kyoto-Katsura Hospital, Kyoto, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Tobaru', 'Affiliation': 'Department of Cardiology, Kawasaki Saiwai Hospital, Kanagawa, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Sakurada', 'Affiliation': 'Department of Cardiology, Tokorozawa Heart Center, Saitama, Japan.'}, {'ForeName': 'Hisayuki', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Division of Cardiology, Seirei Hamamatsu General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Hibi', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Kanagawa, Japan.'}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Zen', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Ikuta', 'Affiliation': 'Department of Cardiology, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Fujii', 'Affiliation': 'Department of Cardiology, Sakurabashi Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Maoto', 'Initials': 'M', 'LastName': 'Habara', 'Affiliation': 'Department of Cardiovascular Medicine, Toyohashi Heart Center, Aichi, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Ako', 'Affiliation': 'Department of Cardiovascular Medicine, Kitasato University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Asano', 'Affiliation': ""Cardiovascular Center, St Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Ozaki', 'Affiliation': 'Department of Cardiology, Itabashi Chuo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Fusazaki', 'Affiliation': 'Division of Cardiology, Iwate Medical University, Iwate, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kozuma', 'Affiliation': 'Department of Cardiology, Teikyo University Hospital, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular intervention and therapeutics,['10.1007/s12928-020-00718-7']
2525,33048300,Approval of Itolizumab for COVID-19: A Premature Decision or Need of The Hour?,"Itolizumab is a first-in-class anti-CD6 monoclonal antibody that was initially developed for various cancers and was later developed and approved in India for treatment of moderate to severe chronic plaque psoriasis in 2013. This drug is now being re-purposed for COVID-19. The potential utility of itolizumab in COVID-19, based on its unique mechanism of action in ameliorating cytokine release syndrome (CRS), was proposed first in Cuba with approval of a single-arm clinical trial and expanded access use. Subsequently, a phase II, open-label, randomized, placebo-controlled trial has been conducted in 30 COVID-19 patients in India after receiving regulatory permission. Based on the results, the Indian drug regulatory agency recently approved itolizumab in July 2020 for 'restricted emergency use' for the treatment of CRS in moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19. This has drawn sharp criticism within the scientific community, with the approval being granted on the basis of a relatively small phase II trial, without conduct of a conventional phase III trial, and lacking availability of the claimed supportive real-world evidence in the public domain to date. In a global scenario where finding a successful treatment for COVID-19 is of utmost priority, a biologic agent has been re-purposed and approved with a successfully completed RCT, in a country where cases and mortality due to COVID-19 are growing exponentially. However, instead of welcoming the approval with open arms, many doubts are being raised. This is an issue that needs to be considered and dealt with sensitively, as well as scientifically.",2020,"The potential utility of itolizumab in COVID-19, based on its unique mechanism of action in ameliorating cytokine release syndrome (CRS), was proposed first in Cuba with approval of a single-arm clinical trial and expanded access use.",['30 COVID-19 patients in India after receiving regulatory permission'],"['itolizumab', 'placebo', 'Itolizumab']",[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0521104', 'cui_str': 'With permission of'}]","[{'cui': 'C2987424', 'cui_str': 'itolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],30.0,0.048248,"The potential utility of itolizumab in COVID-19, based on its unique mechanism of action in ameliorating cytokine release syndrome (CRS), was proposed first in Cuba with approval of a single-arm clinical trial and expanded access use.","[{'ForeName': 'Shubham', 'Initials': 'S', 'LastName': 'Atal', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences Bhopal, 3rd Floor, Medical College Building, Saket Nagar, Bhopal, 462020, India.'}, {'ForeName': 'Zeenat', 'Initials': 'Z', 'LastName': 'Fatima', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences Bhopal, 3rd Floor, Medical College Building, Saket Nagar, Bhopal, 462020, India. zeenat.sr2018@aiimsbhopal.edu.in.'}, {'ForeName': 'Sadasivam', 'Initials': 'S', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences Bhopal, 3rd Floor, Medical College Building, Saket Nagar, Bhopal, 462020, India.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-020-00448-5']
2526,33053431,"Medical assistant health coaching (""MAC"") for type 2 diabetes in diverse primary care settings: A pragmatic, cluster-randomized controlled trial protocol.","In the US, nearly 11% of adults were living with diagnosed diabetes in 2017, and significant type 2 diabetes (T2D) disparities are experienced by socioeconomically disadvantaged, racial/ethnic minority populations, including Hispanics. The standard 15-min primary care visit does not allow for the ongoing self-management support that is needed to meet the complex needs of individuals with diabetes. ""Team-based"" chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to provide ongoing self-management support or ""health coaching."" While rigorous trials have shown MA health coaching to improve diabetes outcomes, less is known about if and how such a model can be integrated within real world, primary care clinic workflows. Medical Assistant Health Coaching for Type 2 Diabetes in Diverse Primary Care Settings - A Pragmatic, Cluster-Randomized Controlled Trial will address this gap. Specifically, this study compares MA health coaching versus usual care in improving diabetes clinical control among N = 600 at-risk adults with T2D, and is being conducted at four primary care clinics that are part of two health systems that serve large, ethnically/racially, and socioeconomically diverse populations in Southern California. Electronic medical records are used to identify eligible patients at both health systems, and to examine change in clinical control over one year in the overall sample. Changes in behavioral and psychosocial outcomes are being evaluated by telephone assessment in a subset (n = 300) of participants, and rigorous process and cost evaluations will assess potential for sustainability and scalability.",2020,"Team-based"" chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to provide ongoing self-management support or ""health coaching.""","['eligible patients at both health systems', 'individuals with diabetes. ', 'diabetes clinical control among N\u202f=\u202f600 at-risk adults with T2D, and is being conducted at four primary care clinics that are part of two health systems that serve large, ethnically/racially, and socioeconomically diverse populations in Southern California']","['Medical Assistant Health Coaching', 'MA health coaching versus usual care', 'Medical assistant health coaching (""MAC']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0334914', 'cui_str': 'Medical assistant'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}]",[],,0.0371121,"Team-based"" chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to provide ongoing self-management support or ""health coaching.""","[{'ForeName': 'Addie L', 'Initials': 'AL', 'LastName': 'Fortmann', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Fortmann.Adelaide@scrippshealth.org.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Philis-Tsimikas.Athena@scrippshealth.org.'}, {'ForeName': 'Johanna A', 'Initials': 'JA', 'LastName': 'Euyoque', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Euyoque.Johanna@scrippshealth.org.'}, {'ForeName': 'Taylor L', 'Initials': 'TL', 'LastName': 'Clark', 'Affiliation': 'San Diego State University/ University of California, San Diego Joint Doctoral Program in Clinical Psychology, 5500 Campanile Dr, San Diego, CA 92182 / 9500 Gilman Drive, La Jolla, CA 92093, United States of America. Electronic address: tlclark@sdsu.edu.'}, {'ForeName': 'Daniela G', 'Initials': 'DG', 'LastName': 'Vital', 'Affiliation': 'San Diego State University Research Foundation, 5500 Campanile Dr, San Diego, CA 92182, USA. Electronic address: dvital@sdsu.edu.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Sandoval', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Sandoval.Haley@scrippshealth.org.'}, {'ForeName': 'Julia I', 'Initials': 'JI', 'LastName': 'Bravin', 'Affiliation': 'San Diego State University/ University of California, San Diego Joint Doctoral Program in Clinical Psychology, 5500 Campanile Dr, San Diego, CA 92182 / 9500 Gilman Drive, La Jolla, CA 92093, United States of America. Electronic address: jbravin-w@sdsu.edu.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Savin', 'Affiliation': 'San Diego State University/ University of California, San Diego Joint Doctoral Program in Clinical Psychology, 5500 Campanile Dr, San Diego, CA 92182 / 9500 Gilman Drive, La Jolla, CA 92093, United States of America. Electronic address: ksavin@sdsu.edu.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Jones', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Jones.Jennifer2@scrippshealth.org.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Roesch', 'Affiliation': 'Department of Psychology, San Diego State University, 5500 Campanile Dr, San Diego, CA 92182, USA. Electronic address: sroesch@sdsu.edu.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Gilmer', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States of America. Electronic address: tgilmer@ucsd.edu.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bodenheimer', 'Affiliation': 'Department of Family and Community Medicine, University of California at San Francisco School of Medicine, 533 Parnassus Ave, San Francisco, CA 94143, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Schultz', 'Affiliation': 'Neighborhood Healthcare, 460 N Elm St, Escondido, CA 92025, USA. Electronic address: jims@nhcare.org.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Gallo', 'Affiliation': 'Department of Psychology, San Diego State University, 5500 Campanile Dr, San Diego, CA 92182, USA. Electronic address: lgallo@sdsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106164']
2527,33053448,Prophylactic foscarnet for human herpesvirus 6: effect on hematopoietic engraftment after reduced intensity conditioning umbilical cord blood transplantation.,"High incidence of human herpesvirus-6 (HHV-6) reactivation, potentially interfering with engraftment after umbilical cord blood (UCB) hematopoietic cell transplantation (HCT), remains a major challenge. To potentially address this problem, we evaluated the effect of prophylactic foscarnet administered twice daily beginning on day +7 and continued through engraftment in 25 patients. In order to determine the impact of foscarnet on HHV6, engraftment and other transplant outcomes, we compared results in 61 identically-treated patients with hematological malignancies. Treatment and control groups underwent reduced intensity conditioning (RIC) UCB HCT with a conditioning regimen of fludarabine, cyclophosphamide, and TBI 200 cGy with or without anti-thymocyte globulin (ATG), using sirolimus plus mycophenolate mofetil immune suppression. The treatment and control groups were similar in age, disease risk, use of ATG, co-morbidity index and graft CD34 cell dose. Foscarnet-treated patients, however, were less likely to receive a double UCB graft and to be treated more recently (2016-2018). Cumulative incidence of HHV-6 reactivation by day +100 was 63% for all patients (95% CI, 51-75) and was not significantly different between the two groups; HHV6 reactivation occurred at a median of 34 days in the foscarnet group and 25.5 days in the control group. The incidence of neutrophil engraftment at day 42 was higher in the foscarnet group than the control group (96% [95% CI, 83 to 100%] versus 75% [95% CI, 64 to 85%], p<0.01). Cumulative incidence of platelet engraftment by 6 months was 92% (95% CI, 69 to 100%) for the foscarnet group versus 75% (95% CI, 60 to 90%) for the control group (p=0.08), and multivariate analysis showed the use of foscarnet was an independent predictor of better platelet engraftment. No patients died as a result of graft failure in recipients of foscarnet, while 5 patients died from graft failure in the control group. Six-month overall survival (OS) and non-relapse mortality (NRM) were better in the foscarnet group (96% vs. 72%, p=0.02 and 4% vs. 18%, p=0.07 respectively). Even though foscarnet prophylaxis did not prevent HHV-6 viremia, we observed a delay in time to HHV-6 reactivation, a trend towards a difference in engraftment, NRM, and OS as compared to historical controls.",2020,"Six-month overall survival (OS) and non-relapse mortality (NRM) were better in the foscarnet group (96% vs. 72%, p=0.02 and 4% vs. 18%, p=0.07 respectively).","['human herpesvirus 6', '25 patients', '61 identically-treated patients with hematological malignancies']","['Foscarnet', 'reduced intensity conditioning (RIC) UCB HCT', 'Prophylactic foscarnet', 'sirolimus plus mycophenolate mofetil', 'prophylactic foscarnet', 'fludarabine, cyclophosphamide, and TBI 200 cGy with or without anti-thymocyte globulin (ATG', 'foscarnet']","['engraftment, NRM, and OS', 'HHV-6 viremia', 'incidence of neutrophil engraftment', 'graft failure', 'hematopoietic engraftment', 'Six-month overall survival (OS) and non-relapse mortality (NRM', 'Cumulative incidence of platelet engraftment', 'HHV6 reactivation', 'Cumulative incidence of HHV-6 reactivation']","[{'cui': 'C0019381', 'cui_str': 'Human herpesvirus 6'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}]","[{'cui': 'C0070895', 'cui_str': 'Foscarnet'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0556645', 'cui_str': 'cGy'}, {'cui': 'C0003442', 'cui_str': 'Lymphocyte Immune Globulin, Anti-Thymocyte Globulin'}]","[{'cui': 'C0301944', 'cui_str': 'Graft acceptance'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0019381', 'cui_str': 'Human herpesvirus 6'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}]",,0.0792836,"Six-month overall survival (OS) and non-relapse mortality (NRM) were better in the foscarnet group (96% vs. 72%, p=0.02 and 4% vs. 18%, p=0.07 respectively).","[{'ForeName': 'Najla', 'Initials': 'N', 'LastName': 'El Jurdi', 'Affiliation': 'Blood and Marrow Transplant Program, Department of Medicine, University of Minnesota. Electronic address: neljurdi@umn.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rogosheske', 'Affiliation': 'Blood and Marrow Transplant Program, Department of Medicine, University of Minnesota.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'DeFor', 'Affiliation': 'Biostatistics and Informatics, Clinical and Translational Science Institute, University of Minnesota.'}, {'ForeName': 'Nelli', 'Initials': 'N', 'LastName': 'Bejanyan', 'Affiliation': 'Blood and Marrow Transplant Program, Department of Medicine, University of Minnesota.'}, {'ForeName': 'Mukta', 'Initials': 'M', 'LastName': 'Arora', 'Affiliation': 'Blood and Marrow Transplant Program, Department of Medicine, University of Minnesota.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Bachanova', 'Affiliation': 'Blood and Marrow Transplant Program, Department of Medicine, University of Minnesota.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Betts', 'Affiliation': 'Blood and Marrow Transplant Program, Department of Medicine, University of Minnesota.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Blood and Marrow Transplant Program, Department of Medicine, University of Minnesota.'}, {'ForeName': 'Shernan', 'Initials': 'S', 'LastName': 'Holtan', 'Affiliation': 'Blood and Marrow Transplant Program, Department of Medicine, University of Minnesota.'}, {'ForeName': 'Murali', 'Initials': 'M', 'LastName': 'Janakiram', 'Affiliation': 'Blood and Marrow Transplant Program, Department of Medicine, University of Minnesota.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Larson', 'Affiliation': 'Blood and Marrow Transplant Program, Department of Medicine, University of Minnesota.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Maakaron', 'Affiliation': 'Blood and Marrow Transplant Program, Department of Medicine, University of Minnesota.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Rashidi', 'Affiliation': 'Blood and Marrow Transplant Program, Department of Medicine, University of Minnesota.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Warlick', 'Affiliation': 'Blood and Marrow Transplant Program, Department of Medicine, University of Minnesota.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Wagner', 'Affiliation': 'Blood and Marrow Transplant Program, Department of Medicine, University of Minnesota.'}, {'ForeName': 'Jo-Anne H', 'Initials': 'JH', 'LastName': 'Young', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA; Division of Infectious Diseases, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weisdorf', 'Affiliation': 'Blood and Marrow Transplant Program, Department of Medicine, University of Minnesota.'}, {'ForeName': 'Claudio G', 'Initials': 'CG', 'LastName': 'Brunstein', 'Affiliation': 'Blood and Marrow Transplant Program, Department of Medicine, University of Minnesota.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.10.008']
2528,33053456,Symptoms of gluten ingestion in patients with non-celiac gluten sensitivity: A randomized clinical trial.,"OBJECTIVES


Non-celiac gluten sensitivity (NCGS) is the presence of symptoms induced by gluten and relieved by a gluten-free diet (GFD) in patients without celiac disease or wheat allergy. Studies are mixed as to whether gluten is the main symptom trigger in patients with NCGS. Gluten immunogenic peptides (GIPs) in stool and urine are novel methods to monitor GFD compliance. Few studies have investigated their use in patients with NCGS. The aim of this study was to assess whether patients with NCGS have increased symptoms with gluten ingestion and to assess compliance with the GFD using stool and urine GIPs.
METHOD


This was a prospective, randomized, double-blinded crossover trial evaluating symptoms in patients with NCGS. Thirty patients with NCGS and 43 healthy controls were placed on a GFD. Patients received 0.5 or 2 g/d of gluten for 7 d each. The remaining weeks, they received placebo for a total of 4 wk. Symptoms were evaluated weekly using the Celiac Symptom Index (CSI). Urine and stool samples were collected weekly and measured for the detection of GIPs to detect exposure to gluten.
RESULTS


There was no difference in symptom severity within the NCGS group whether receiving placebo or gluten (32.69 versus 31.54, P = 0.64). Patients with NCGS had significantly higher CSI scores at baseline than healthy controls. Patients with NCGS were less likely to have stool and urine GIPs than healthy patients.
CONCLUSION


Patients with NCGS were more adherent to the GFD based on stool and urine GIP results. Patients with NCGS had increased symptom severity at baseline compared with healthy controls. Neither group had significantly increased symptoms after ingestion of gluten.",2020,"There was no difference in symptom severity within the NCGS group whether receiving placebo or gluten (32.69 versus 31.54, P = 0.64).","['Thirty patients with NCGS and 43 healthy controls', 'Patients with NCGS', 'patients with NCGS', 'patients without celiac disease or wheat allergy', 'patients with non-celiac gluten sensitivity']","['Gluten immunogenic peptides (GIPs', 'NCGS', 'placebo']","['Urine and stool samples', 'stool and urine GIPs', 'CSI scores', 'symptom severity', 'symptoms after ingestion of gluten', 'Celiac Symptom Index (CSI']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711053', 'cui_str': 'Non-celiac gluten sensitivity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0949570', 'cui_str': 'Allergy to wheat'}]","[{'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C2711053', 'cui_str': 'Non-celiac gluten sensitivity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C1550661', 'cui_str': 'Stool specimen'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]",30.0,0.18729,"There was no difference in symptom severity within the NCGS group whether receiving placebo or gluten (32.69 versus 31.54, P = 0.64).","[{'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Moleski', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States. Electronic address: Stephanie.moleski@jefferson.edu.'}, {'ForeName': 'Apeksha', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Cooper University Hospital, Camden, New Jersey, United States.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Durney', 'Affiliation': 'Department of Medicine, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Matthews', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Kaushal', 'Affiliation': 'Jefferson College of Pharmacy, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Katelyn C', 'Initials': 'KC', 'LastName': 'Koons', 'Affiliation': 'Sidney Kimmel Medical College, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Rubin', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Casey', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Mahreema', 'Initials': 'M', 'LastName': 'Jawairia', 'Affiliation': 'Lehigh Gastroenterology Associates, Palmerton, Pennsylvania, United States.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Lehigh Gastroenterology Associates, Palmerton, Pennsylvania, United States.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'DiMarino', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110944']
2529,33053536,Comparison of curative effect between different anticoagulation regimens in continuous renal replacement therapy after cardiac valve replacement.,"OBJECTIVES


To compare the clinical effect of low molecular weight heparin (LMWH) and regional citrate anticoagulation (RCA) in continuous renal replacement therapy (CRRT) after heart valve replacement.
METHODS


Retrospective analysis of clinical data from 60 patients undergoing continuous renal replacement therapy after heart valve replacement in Peking University Shenzhen Hospital from January 2015 to July 2019, including 35 males and 25 females, aged (58.83 ±16.36) years. The patients were divided into a LMWH group and a RCA group according to the anticoagulation regimen, with 30 patients in each group. The 24 h postoperative drainage volume (pericardium, mediastinum), postoperative ventilator use time and ICU stay time, incidence of postoperative respiratory tract bleeding and gastrointestinal bleeding, postoperative skin ecchymosis incidence and mortality between the 2 groups were compared; the thromboplastin time (APTT), fibrinogen (FIB), thrombin time (TT), prothrombin time (PT), international normalized ratio (INR), and PLT between the 2 groups after anticoagulation treatment were compared; the service life of dialysis filters and CRRT time between the 2 groups were compared; and the levels of urea nitrogen and serum creatinine between the 2 groups before and after treatment were also compared.
RESULTS


After anticoagulant treatment, the RCA group had less 24 h postoperative drainage volume than the LMWH group, shorter ventilator use time, ICU stay time, and hospitalization days than the LMWH group, and lower respiratory tract bleeding and gastrointestinal bleeding incidence than the LMWH group, with significant differences (all  P <0.05); there was no significant difference in the incidence of skin ecchymosis and mortality after treatment between the 2 groups (all  P >0.05); there was no significant difference in APTT, FIB, and TT between the 2 groups (all  P >0.05); the PT and INR of the RCA group were higher than those in the LMWH group, while the PLT of RCA group was lower than that in the LMWH group, with significant differences (all  P <0.05); there was no significant difference in CRRT time between the two groups ( P =0.073). After the treatment, there were no significant differences in urea nitrogen and serum creatinine levels between the 2 groups (all  P >0.05).
CONCLUSIONS


CRRT after cardiac valve replacement with RCA can effectively reduce pericardial and mediastinal drainage, reduce the risk of bleeding, shorten the time of ventilator use and ICU stay, and promote postoperative recovery of patients, which have positive significance for reducing the burden on patients and their families.",2020,"After anticoagulant treatment, the RCA group had less 24 h postoperative drainage volume than the LMWH group, shorter ventilator use time, ICU stay time, and hospitalization days than the LMWH group, and lower respiratory tract bleeding and gastrointestinal bleeding incidence than the LMWH group, with significant differences (all  P <0.05); there was no significant difference in the incidence of skin ecchymosis and mortality after treatment between the 2 groups (all  P >0.05); there was no significant difference in APTT, FIB, and TT between the 2 groups (all  P >0.05); the PT and INR of the RCA group were higher than those in the LMWH group, while the PLT of RCA group was lower than that in the LMWH group, with significant differences (all  P <0.05); there was no significant difference in CRRT time between the two groups ( P =0.073).","['continuous renal replacement therapy after cardiac valve replacement', 'continuous renal replacement therapy (CRRT) after heart valve replacement', '60 patients undergoing continuous renal replacement therapy after heart valve replacement in Peking University Shenzhen Hospital from January 2015 to July 2019, including 35 males and 25 females, aged (58.83 ±16.36) years']","['low molecular weight heparin (LMWH) and regional citrate anticoagulation (RCA', 'RCA', 'LMWH']","['respiratory tract bleeding and gastrointestinal bleeding incidence', 'postoperative drainage volume (pericardium, mediastinum), postoperative ventilator use time and ICU stay time, incidence of postoperative respiratory tract bleeding and gastrointestinal bleeding, postoperative skin ecchymosis incidence and mortality', 'CRRT time', 'shorter ventilator use time, ICU stay time, and hospitalization days', 'postoperative drainage volume', 'incidence of skin ecchymosis and mortality', 'thromboplastin time (APTT), fibrinogen (FIB), thrombin time (TT), prothrombin time (PT), international normalized ratio (INR), and PLT', 'APTT, FIB, and TT', 'PT and INR', 'risk of bleeding, shorten the time of ventilator use and ICU stay', 'service life of dialysis filters and CRRT time', 'levels of urea nitrogen and serum creatinine', 'urea nitrogen and serum creatinine levels']","[{'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0190173', 'cui_str': 'Heart valve replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}]","[{'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0031050', 'cui_str': 'Pericardial sac structure'}, {'cui': 'C0025066', 'cui_str': 'Mediastinal'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040048', 'cui_str': 'Thromboplastin'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0677634', 'cui_str': 'Reptilase time'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0201617', 'cui_str': 'Primed lymphocyte test'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}]",60.0,0.0131365,"After anticoagulant treatment, the RCA group had less 24 h postoperative drainage volume than the LMWH group, shorter ventilator use time, ICU stay time, and hospitalization days than the LMWH group, and lower respiratory tract bleeding and gastrointestinal bleeding incidence than the LMWH group, with significant differences (all  P <0.05); there was no significant difference in the incidence of skin ecchymosis and mortality after treatment between the 2 groups (all  P >0.05); there was no significant difference in APTT, FIB, and TT between the 2 groups (all  P >0.05); the PT and INR of the RCA group were higher than those in the LMWH group, while the PLT of RCA group was lower than that in the LMWH group, with significant differences (all  P <0.05); there was no significant difference in CRRT time between the two groups ( P =0.073).","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'Blood Purification Center, Peking University Shenzhen Hospital, Shenzhen Guangdong 518036. 316796241@qq.com.'}, {'ForeName': 'Changshuai', 'Initials': 'C', 'LastName': 'Song', 'Affiliation': 'Blood Purification Center, Peking University Shenzhen Hospital, Shenzhen Guangdong 518036.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Blood Purification Center, Peking University Shenzhen Hospital, Shenzhen Guangdong 518036.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Ouyang', 'Affiliation': 'Department of Cardiovascular Surgery, Peking University Shenzhen Hospital, Shenzhen Guangdong 518036, China.'}, {'ForeName': 'Xiaoqiang', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Department of Cardiovascular Surgery, Peking University Shenzhen Hospital, Shenzhen Guangdong 518036, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiovascular Surgery, Peking University Shenzhen Hospital, Shenzhen Guangdong 518036, China. doctorlay@163.com.'}]",Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences,['10.11817/j.issn.1672-7347.2020.190750']
2530,33053622,Ticagrelor Versus Clopidogrel in Older Patients with NSTE-ACS Using Oral Anticoagulation: A Sub-Analysis of the POPular Age Trial.,"There are no randomised data on which antiplatelet agent to use in elderly patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) and an indication for oral anticoagulation (OAC). The randomised POPular Age trial, in patients of 70 years or older with NSTE-ACS, showed a reduction in bleeding without increasing thrombotic events in patients using clopidogrel as compared to ticagrelor. In this sub-analysis of the POPular AGE trial, we compare clopidogrel with ticagrelor in patients with a need for oral anticoagulation. The follow-up duration was one year. The primary bleeding outcome was Platelet Inhibition and Patient Outcomes (PLATO) major and minor bleeding. The primary thrombotic outcome consisted of cardiovascular death, myocardial infarction and stroke. The primary net clinical benefit outcome was a composite of all-cause death, myocardial infarction, stroke, and PLATO major and minor bleeding. A total of 184/1011 (18.2%) patients on OAC were included in this subanalysis; 83 were randomized to clopidogrel and 101 to ticagrelor. The primary bleeding outcome was lower in the clopidogrel group (17/83, 20.9%) compared to the ticagrelor group (33/101, 33.5%;  p  = 0.051), as was the thrombotic outcome (7/83, 8.4% vs. 19/101, 19.2%;  p  = 0.035) and the primary net clinical benefit outcome (23/83, 27.7% vs. 49/101, 48.5%;  p  = 0.003). In this subgroup of patients using OAC, clopidogrel reduced PLATO major and minor bleeding compared to ticagrelor without increasing thrombotic risk. This analysis therefore suggests that, in line with the POPular Age trial, clopidogrel is a better option than ticagrelor in NSTE-ACS patients ≥70 years using OAC.",2020,"In this subgroup of patients using OAC, clopidogrel reduced PLATO major and minor bleeding compared to ticagrelor without increasing thrombotic risk.","['A total of 184/1011 (18.2%) patients on OAC', 'patients with a need for oral anticoagulation', 'Older Patients with NSTE-ACS', 'elderly patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) and an indication for oral anticoagulation (OAC', 'patients of 70 years or older with NSTE-ACS']","['Oral Anticoagulation', 'clopidogrel with ticagrelor', 'Ticagrelor Versus Clopidogrel', 'clopidogrel', 'ticagrelor']","['primary bleeding outcome', 'thrombotic risk', 'bleeding without increasing thrombotic events', 'composite of all-cause death, myocardial infarction, stroke, and PLATO major and minor bleeding', 'thrombotic outcome', 'cardiovascular death, myocardial infarction and stroke', 'Platelet Inhibition and Patient Outcomes (PLATO) major and minor bleeding']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517610', 'cui_str': '18.2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0043566', 'cui_str': '(1,2-diamino-4-nitrobenzene)dichloroplatinum(II)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.110778,"In this subgroup of patients using OAC, clopidogrel reduced PLATO major and minor bleeding compared to ticagrelor without increasing thrombotic risk.","[{'ForeName': 'Marieke E', 'Initials': 'ME', 'LastName': 'Gimbel', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, 3435CM Nieuwegein, The Netherlands.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Tavenier', 'Affiliation': 'Department of Cardiology, Isala, 8025AB Zwolle, The Netherlands.'}, {'ForeName': 'Wilbert', 'Initials': 'W', 'LastName': 'Bor', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, 3435CM Nieuwegein, The Netherlands.'}, {'ForeName': 'Renicus S', 'Initials': 'RS', 'LastName': 'Hermanides', 'Affiliation': 'Department of Cardiology, Isala, 8025AB Zwolle, The Netherlands.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'de Vrey', 'Affiliation': 'Department of Cardiology, Meander Medical Centre, 3813TZ Amersfoort, The Netherlands.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Heestermans', 'Affiliation': 'Department of Cardiology, Noord-west Hospital group, 1815JD Alkmaar, The Netherlands.'}, {'ForeName': 'Melvyn Tjon Joe', 'Initials': 'MTJ', 'LastName': 'Gin', 'Affiliation': 'Department of Cardiology, Rijnstate, 6815AD Arnhem, The Netherlands.'}, {'ForeName': 'Reinier', 'Initials': 'R', 'LastName': 'Waalewijn', 'Affiliation': 'Department of Cardiology, Gelre Hospitals, 7334DZ Apeldoorn, The Netherlands.'}, {'ForeName': 'Sjoerd', 'Initials': 'S', 'LastName': 'Hofma', 'Affiliation': 'Department of Cardiology, Medical Centre Leeuwarden, 8934AD Leeuwarden, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'den Hartog', 'Affiliation': 'Department of Cardiology, Gelderse Vallei Hospital, 6716RP Ede, The Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leids University Medical Centre, 2333ZA Leiden, The Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Medisch Spectrum Twente, 7512KZ Enschede, The Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Voskuil', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, 3584CX Utrecht, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kelder', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, 3435CM Nieuwegein, The Netherlands.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Deneer', 'Affiliation': 'Department of Clinical Pharmacy, Division of Laboratories, Pharmacy, and Biomedical Genetics University, Medical Center Utrecht and Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, 3584CX Utrecht, The Netherlands.'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, 3435CM Nieuwegein, The Netherlands.'}]",Journal of clinical medicine,['10.3390/jcm9103249']
2531,33053626,"Effect of Food Containing Paramylon Derived from  Euglena gracilis  EOD-1 on Fatigue in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial.","Euglena gracilis  EOD-1, a kind of microalgae, is known to contain a high proportion of paramylon, a type of β-1,3-glucan. Paramylon derived from  E. gracilis  EOD-1 is presumed to suppress cellular oxidative injury and expected to reduce fatigue and fatigue sensation. Therefore, we aimed to examine whether food containing paramylon derived from  E. gracilis  EOD-1 (EOD-1PM) ingestion reduced fatigue and fatigue sensation in healthy adults. We conducted a randomized, double-blind, placebo-controlled, parallel-group comparison study in 66 healthy men and women who ingested a placebo or EOD-1PM daily for 4 weeks (daily life fatigue). Furthermore, at the examination days of 0 and 4 weeks, tolerance to fatigue load was evaluated using mental tasks (task-induced fatigue). We evaluated fatigue sensation using the Visual Analogue Scale, the work efficiency of the advanced trail making test and measured serum antioxidant markers. The EOD-1PM group showed significantly lower levels of physical and mental fatigue sensations and higher levels of work efficiency as well as serum biological antioxidant potential levels than the placebo group. These results indicate that EOD-1PM ingestion reduced fatigue and fatigue sensation, which may be due to an increase in antioxidant potential and maintenance of selective attention during work.",2020,The EOD-1PM group showed significantly lower levels of physical and mental fatigue sensations and higher levels of work efficiency as well as serum biological antioxidant potential levels than the placebo group.,"['Healthy Adults', 'daily for 4 weeks (daily life fatigue', 'healthy adults', '66 healthy men and women who ingested a']","['Food Containing Paramylon', 'EOD-1PM', 'placebo or EOD-1PM', 'EOD-1PM ingestion', 'food containing paramylon derived from  E. gracilis  EOD-1 (EOD-1PM) ingestion', 'placebo', 'Placebo']","['tolerance to fatigue load', 'fatigue sensation', 'levels of physical and mental fatigue sensations', 'fatigue and fatigue sensation', 'serum biological antioxidant potential levels']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0070074', 'cui_str': 'paramylon'}, {'cui': 'C1509133', 'cui_str': 'post meridiem'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0224439', 'cui_str': 'Structure of gracilis muscle'}]","[{'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4049351', 'cui_str': 'Biological antioxidant potential'}]",66.0,0.441904,The EOD-1PM group showed significantly lower levels of physical and mental fatigue sensations and higher levels of work efficiency as well as serum biological antioxidant potential levels than the placebo group.,"[{'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Kawano', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Naito', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Machiko', 'Initials': 'M', 'LastName': 'Nishioka', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Norihisa', 'Initials': 'N', 'LastName': 'Nishida', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Madoka', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Kashiwagi', 'Affiliation': 'Soiken. Inc., Toyonaka, Osaka 560-0082, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Sugino', 'Affiliation': 'Soiken. Inc., Toyonaka, Osaka 560-0082, Japan.'}, {'ForeName': 'Yasuyoshi', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'RIKEN Center for Biosystems Dynamics Research, Kobe, Hyogo 650-0047, Japan.'}]",Nutrients,['10.3390/nu12103098']
2532,33053651,Effects of Physical Rehabilitation and Nutritional Intake Management on Improvement in Tongue Strength in Sarcopenic Patients.,"The study aimed to investigate the impact of physical intervention and the amount of nutritional intake on the increase in tongue strength and swallowing function in older adults with sarcopenia. From November 2018 and May 2019, older patients with sarcopenia who were admitted for rehabilitation were analyzed. The intervention employed in the study was the usual physical and occupational therapy for two months. Tongue strength was measured before and after two months of treatment. Data on tongue strength, the amount of energy and protein intake, intervention time, and swallowing function were examined. A total of 95 sarcopenic older patients were included (mean age 83.4 ± 6.5 years). The mean tongue strength after the intervention was significantly increased from 25.4 ± 8.9 kPa to 30.5 ± 7.6 kPa as a result of the treatment ( p  < 0.001). After adjusting the confounding factors in the multivariable models, an energy intake of ≥30 kcal/kg/day and a protein intake of ≥1.2 g/kg/day based on the ideal body weight had a significant impact on the increase in tongue strength after the treatment ( p  = 0.011 and  p  = 0.020, respectively). Swallowing function assessed using the Mann Assessment of Swallowing Ability was significantly increased after the treatment (mean difference between pairs: 1.12 [0.53-1.70];  p  < 0.001). Physical intervention and strict nutritional management for older inpatients with sarcopenia could be effective to improve tongue strength and swallowing function.",2020,Swallowing function assessed using the Mann Assessment of Swallowing Ability was significantly increased after the treatment (mean difference between pairs: 1.12 [0.53-1.70];  p  < 0.001).,"['older adults with sarcopenia', 'Sarcopenic Patients', '95 sarcopenic older patients were included (mean age 83.4 ± 6.5 years', 'older inpatients with sarcopenia', 'From November 2018 and May 2019, older patients with sarcopenia who were admitted for rehabilitation were analyzed']","['Physical Rehabilitation and Nutritional Intake Management', 'Physical intervention and strict nutritional management', 'physical intervention']","['tongue strength, the amount of energy and protein intake, intervention time, and swallowing function', 'mean tongue strength', 'Swallowing function assessed using the Mann Assessment of Swallowing Ability', 'Tongue strength', 'tongue strength', 'tongue strength and swallowing function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0566355', 'cui_str': 'Ability to swallow'}]",95.0,0.0128166,Swallowing function assessed using the Mann Assessment of Swallowing Ability was significantly increased after the treatment (mean difference between pairs: 1.12 [0.53-1.70];  p  < 0.001).,"[{'ForeName': 'Ayano', 'Initials': 'A', 'LastName': 'Nagano', 'Affiliation': 'Department of Nursing, Nishinomiya Kyoritsu Neurosurgical Hospital, 11-1 Imazuyamanaka-cho, Nishinomiya, Hyogo 663-8211, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'Department of Geriatric Medicine, National Center for Geriatrics and Gerontology, 7-430 Morioka, Obu, Aichi 474-8511, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Koike', 'Affiliation': 'Division of Rehabilitation, Chuzan Hospital, 6-2-1 Matsumoto, Okinawa 904-2151, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Murotani', 'Affiliation': 'Biostatistics Center, Kurume University, 67 Asahimachi, Kurume 830-0011, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Ueshima', 'Affiliation': 'Department of Clinical Nutrition and Food Service, NTT Medical Center Tokyo, 5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo 141-8625, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Shimizu', 'Affiliation': 'Department of Nutrition, Hamamatsu City Rehabilitation Hospital, 1-6-1 Wago-kita, Naka-ku, Hamamatsu, Shizuoka 433-8127, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata 950-3198, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Okinawa Chuzan Hospital Clinical Research Center, Chuzan Hospital, 6-2-1 Matsumoto, Okinawa 904-2151, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Suenaga', 'Affiliation': 'Department of Rehabilitation Medicine, Chuzan Hospital, 6-2-1 Matsumoto, Okinawa 904-2151, Japan.'}, {'ForeName': 'Yuria', 'Initials': 'Y', 'LastName': 'Ishida', 'Affiliation': 'Department of Nutrition, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan.'}, {'ForeName': 'Naoharu', 'Initials': 'N', 'LastName': 'Mori', 'Affiliation': 'Department of Palliative and Supportive Medicine, Graduate School of Medicine, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan.'}]",Nutrients,['10.3390/nu12103104']
2533,33053728,Effect of Psycho-Regulatory Massage Therapy on Pain and Depression in Women with Chronic and/or Somatoform Back Pain: A Randomized Controlled Trial.,"Chronic unspecific back pain (cBP) is often associated with depressive symptoms, negative body perception, and abnormal interoception. Given the general failure of surgery in cBP, treatment guidelines focus on conservative therapies. Neurophysiological evidence indicates that C-tactile fibers associated with the oxytonergic system can be activated by slow superficial stroking of the skin in the back, shoulder, neck, and dorsal limb areas. We hypothesize that, through recruitment of C-tactile fibers, psycho-regulatory massage therapy (PRMT) can reduce pain in patients with cBP. In our study, 66 patients were randomized to PRMT or CMT (classical massage therapy) over a 12-week period and tested by questionnaires regarding pain (HSAL= Hamburger Schmerz Adjektiv Liste; Hamburg Pain adjective list), depression (BDI-II = Beck depression inventory), and disability (ODI = Oswestry Disability Index). In all outcome measures, patients receiving PRMT improved significantly more than did those receiving CMT. The mean values of the HSAL sensory subscale decreased by -51.5% in the PRMT group compared to -6.7% in the CMT group. Depressive symptoms were reduced by -55.69% (PRMT) and -3.1% (CMT), respectively. The results suggest that the superiority of PRMT over CMT may rely on its ability to activate the C-tactile fibers of superficial skin layers, recruiting the oxytonergic system.",2020,"Depressive symptoms were reduced by -55.69% (PRMT) and -3.1% (CMT), respectively.","['Chronic unspecific back pain (cBP', '66 patients', 'patients with cBP', 'Women with Chronic and/or Somatoform Back Pain']","['Psycho-Regulatory Massage Therapy', 'psycho-regulatory massage therapy (PRMT', 'PRMT or CMT (classical massage therapy', 'PRMT']","[' Beck depression inventory), and disability (ODI = Oswestry Disability Index', 'patients receiving PRMT', 'mean values of the HSAL sensory subscale', 'Pain and Depression', 'pain (HSAL= Hamburger Schmerz Adjektiv Liste; Hamburg Pain adjective list), depression (BDI-II', 'Depressive symptoms']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",66.0,0.0581292,"Depressive symptoms were reduced by -55.69% (PRMT) and -3.1% (CMT), respectively.","[{'ForeName': 'Sabine B-E', 'Initials': 'SB', 'LastName': 'Baumgart', 'Affiliation': 'Faculty of Medicine, Institute for Health and Nursing Sciences, Martin Luther University Halle-Wittenberg, 06108 Halle, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Baumbach-Kraft', 'Affiliation': 'M.Sc. Public Health, 24105 Kiel, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Lorenz', 'Affiliation': 'Department of Biomedical Engineering, Faculty of Life Science, University of Applied Sciences, 21033-Hamburg, Germany.'}]",Brain sciences,['10.3390/brainsci10100721']
2534,30741682,Cerebral Amyloid-β Deposition Is Associated with Impaired Gait Speed and Lower Extremity Function.,"BACKGROUND


Impaired physical function (i.e., slowing of gait, muscle weakness, and poor mobility) is common in older adults with cognitive impairment and dementia. Evidence suggests that cerebral small vessel disease, specifically white matter lesions (WMLs), is associated with impaired physical function, but little research has been conducted to understand the specific role of Alzheimer's disease pathology in physical outcomes.
OBJECTIVE


The objective of this study was to examine the association between cerebral amyloid-β (Aβ) deposition and physical function in people with cognitive impairment.
METHODS


Thirty participants completed an 11C Pittsburgh compound B (PIB) position emission tomography (PET) scan to quantify global Aβ deposition using standardized uptake value ratio (SUVR). We assessed usual gait speed, muscle strength of the lower extremities, balance, and functional mobility using the Short Physical Performance Battery (SPPB) and the Timed Up and Go Test (TUGT). Multiple linear regression analyses examined the association between Aβ and each measure of physical function, adjusting for age, body mass index, and WML load.
RESULTS


Global PIB SUVR was significantly associated with usual gait speed (β= -0.52, p = 0.01) and SPPB performance (β= -0.47, p = 0.02), such that increased Aβ deposition was associated with reduced performance on both measures. Global PIB SUVR was not significantly associated with TUGT performance (β= 0.32, p = 0.08).
CONCLUSIONS


Cerebral Aβ deposition is associated with reduced gait speed, muscle strength, and balance in older adults with cognitive impairment independent of WML load. However, Aβ deposition was not associated with functional mobility.",2019,"Global PIB SUVR was not significantly associated with TUGT performance (β= 0.32, p = 0.08).
","['people with cognitive impairment', 'Thirty participants completed an', 'older adults with cognitive impairment independent of WML load', 'older adults with cognitive impairment and dementia']",['11C Pittsburgh compound B (PIB) position emission tomography (PET) scan'],"['Gait Speed and Lower Extremity Function', 'SPPB performance', 'usual gait speed, muscle strength of the lower extremities, balance, and functional mobility using the Short Physical Performance Battery (SPPB) and the Timed Up and Go Test (TUGT', 'gait speed, muscle strength, and balance', 'usual gait speed', 'Global PIB SUVR', 'cerebral amyloid-β (Aβ) deposition and physical function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C1568156', 'cui_str': 'Pittsburgh compound B'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1568156', 'cui_str': 'Pittsburgh compound B'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",30.0,0.0462502,"Global PIB SUVR was not significantly associated with TUGT performance (β= 0.32, p = 0.08).
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Dao', 'Affiliation': 'Department of Physical Therapy, University of British Columbia (UBC), Vancouver, Canada.'}, {'ForeName': 'Ging-Yuek Robin', 'Initials': 'GR', 'LastName': 'Hsiung', 'Affiliation': 'Djavad Mowafaghian Centre for Brain Health, Vancouver Coastal Health Research Institute, Vancouver, Canada.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Sossi', 'Affiliation': 'Department of Physics and Astronomy, UBC, Vancouver, Canada.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Tam', 'Affiliation': 'Department of Radiology, UBC, Vancouver, Canada.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Shahinfard', 'Affiliation': 'Department of Physics and Astronomy, UBC, Vancouver, Canada.'}, {'ForeName': 'Eloise', 'Initials': 'E', 'LastName': 'Nicklin', 'Affiliation': 'Djavad Mowafaghian Centre for Brain Health, Vancouver Coastal Health Research Institute, Vancouver, Canada.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Al Keridy', 'Affiliation': 'Djavad Mowafaghian Centre for Brain Health, Vancouver Coastal Health Research Institute, Vancouver, Canada.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Liu-Ambrose', 'Affiliation': 'Department of Physical Therapy, University of British Columbia (UBC), Vancouver, Canada.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-180848']
2535,30916382,"Regardless of how risks are framed, patients seem hesitant to use topical steroids for atopic dermatitis.",,2019,,[],[],[],[],[],[],,0.0151701,,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Maghen', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC, U.S.A.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Unrue', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC, U.S.A.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Oussedik', 'Affiliation': 'Faculty of Medicine, McGill University, Montreal, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cline', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC, U.S.A.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Cardwell', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC, U.S.A.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Feldman', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.17929']
2536,30972731,Clinical response of psoriasis to subcutaneous methotrexate correlates with inhibition of cutaneous T helper 1 and 17 inflammatory pathways.,,2019,,[],['subcutaneous methotrexate'],[],[],"[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]",[],,0.0192655,,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Germany.'}, {'ForeName': 'J L K', 'Initials': 'JLK', 'LastName': 'Reich', 'Affiliation': 'School of Medicine, Imperial College London, U.K.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Falk', 'Affiliation': 'Dermatologikum Hamburg, Hamburg, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Blödorn-Schlicht', 'Affiliation': 'Dermatologikum Hamburg, Hamburg, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Mrowietz', 'Affiliation': 'Psoriasis-Centre, Department of Dermatology, University Medical Centre Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'von Kiedrowski', 'Affiliation': 'Company for Medical Study & Service, Selters, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Dermatology and Allergology, University of Ulm, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Niesmann', 'Affiliation': 'Hautzentrum im Jahrhundert Haus - Centre for Clinical Trials, Bochum, Germany.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Frambach', 'Affiliation': 'Hautarztpraxis Lübeck, Lübeck, Germany.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Dermatological Sciences, University of Manchester, Manchester, U.K.'}]",The British journal of dermatology,['10.1111/bjd.18001']
2537,30972743,Facebook advertising for cancer prevention: a pilot study.,,2019,,[],[],[],[],[],[],,0.020151,,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Morrison', 'Affiliation': 'Program for Clinical Research, Department of Dermatology, University of California San Francisco, San Francisco, CA, U.S.A.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, University of California San Francisco, San Francisco, CA, U.S.A.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Torres', 'Affiliation': 'Program for Clinical Research, Department of Dermatology, University of California San Francisco, San Francisco, CA, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wehner', 'Affiliation': 'Department of Dermatology, University of Pennsylvania, Philadelphia, PA, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Junn', 'Affiliation': 'Program for Clinical Research, Department of Dermatology, University of California San Francisco, San Francisco, CA, U.S.A.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Linos', 'Affiliation': 'Program for Clinical Research, Department of Dermatology, University of California San Francisco, San Francisco, CA, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.17993']
2538,33050920,Acute toxicity of normofractionated intensity modulated radiotherapy with simultaneous integrated boost compared to three-dimensional conformal radiotherapy with sequential boost in the adjuvant treatment of breast cancer.,"BACKGROUND


Intensity-modulated radiotherapy (IMRT) improves dose homogeneity and late toxicity compared to simple tangential techniques in adjuvant whole-breast radiotherapy for patients with breast cancer. Simultaneous-integrated boost (SIB) radiotherapy shortens the overall treatment time and improves dose homogeneity. However, prospective randomized trials regarding IMRT with SIB for adjuvant radiotherapy in breast cancer are lacking.
METHODS


The IMRT-MC2 (MINT) trial is a phase III prospective randomized controlled trial comparing IMRT with SIB (Arm A: whole breast 28 × 1.8 Gy, Boost 28 × 2.3 Gy) to 3D-conformal radiotherapy with a sequential boost (Arm B: whole breast 28 × 1.8 Gy, boost 8 × 2 Gy) in patients with breast cancer after BCS. Indication for boost radiotherapy was defined as age < 70 years or age > 70 years with presence of additional risk factors. This is a retrospective analysis of acute toxicity at one of two trial sites.
RESULTS


Five hundred two patients were randomized, of which 446 patients were eligible for this analysis. There was no statistically significant difference in terms of any grade radiation dermatitis between the two treatment arms at the end of treatment (p = 0.26). However, radiation dermatitis grade 2/3 (29.1% vs. 20.1 and 3.5% vs. 2.3%) occurred significantly more often in Arm A (p = 0.02). Breast/chest wall pain at the first follow-up visit was significantly more common in patients treated on Arm B (p = 0.02).
CONCLUSIONS


Treatment on both arms was well tolerated, however there were some differences regarding radiodermatitis and breast pain. Further analyses are ongoing.
TRIAL REGISTRATION


clinicaltrials.gov , NCT01322854 , registered 24th March 2011.",2020,There was no statistically significant difference in terms of any grade radiation dermatitis between the two treatment arms at the end of treatment (p = 0.26).,"['Five hundred two patients were randomized, of which 446 patients were eligible for this analysis', 'patients with breast cancer after BCS', 'breast cancer', 'patients with breast cancer', 'age\u2009<\u200970\u2009years or age\u2009>\u200970\u2009years with presence of additional risk factors', 'with SIB (Arm A: whole breast 28\u2009×\u20091.8']","['Simultaneous-integrated boost (SIB) radiotherapy', 'boost radiotherapy', 'adjuvant radiotherapy', 'Intensity-modulated radiotherapy (IMRT', 'IMRT', 'normofractionated intensity modulated radiotherapy']","['Breast/chest wall pain', 'grade radiation dermatitis', 'radiodermatitis and breast pain', 'Acute toxicity']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C4068742', 'cui_str': '1.8'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C2919491', 'cui_str': 'Boost radiation therapy'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0008035', 'cui_str': 'Chest wall pain'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0034561', 'cui_str': 'Radiation dermatitis'}, {'cui': 'C0024902', 'cui_str': 'Pain of breast'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",446.0,0.172031,There was no statistically significant difference in terms of any grade radiation dermatitis between the two treatment arms at the end of treatment (p = 0.26).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krug', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany. david.krug@uksh.de.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Köder', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Matthias F', 'Initials': 'MF', 'LastName': 'Häfner', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Arians', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Semi B', 'Initials': 'SB', 'LastName': 'Harrabi', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Stefan A', 'Initials': 'SA', 'LastName': 'Koerber', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Forster', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Ingmar', 'Initials': 'I', 'LastName': 'Schlampp', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Sohn', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Heil', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Hof', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Hörner-Rieber', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Debus', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}]","Radiation oncology (London, England)",['10.1186/s13014-020-01652-x']
2539,33050924,Home Treatment of Older People with Symptomatic SARS-CoV-2 Infection (COVID-19): A structured Summary of a Study Protocol for a Multi-Arm Multi-Stage (MAMS) Randomized Trial to Evaluate the Efficacy and Tolerability of Several Experimental Treatments to Reduce the Risk of Hospitalisation or Death in outpatients aged 65 years or older (COVERAGE trial).,"OBJECTIVES


To assess the efficacy of several repurposed drugs to prevent hospitalisation or death in patients aged 65 or more with recent symptomatic SARS-CoV-2 infection (COVID-19) and no criteria for hospitalisation.
TRIAL DESIGN


Phase III, multi-arm (5) and multi-stage (MAMS), randomized, open-label controlled superiority trial. Participants will be randomly allocated 1:1:1:1:1 to the following strategies: Arm 1: Control arm Arms 2 to 5: Experimental treatment arms Planned interim analyses will be conducted at regular intervals. Their results will be reviewed by an Independent Data and Safety Monitoring Board. Experimental arms may be terminated for futility, efficacy or toxicity before the end of the trial. New experimental arms may be added if new evidence suggests that other treatments should be tested. A feasibility and acceptability substudy as well as an immunological substudy will be conducted alongside the trial.
PARTICIPANTS


Inclusion criteria are: 65-year-old or more; Positive test for SARS-CoV-2 on a nasopharyngeal swab; Symptoms onset within 3 days before diagnosis; No hospitalisation criteria; Signed informed consent; Health insurance. Exclusion criteria are: Inability to make an informed decision to participate (e.g.: dementia, guardianship); Rockwood Clinical Frailty Scale ≥7; Long QT syndrome; QTc interval > 500 ms; Heart rate <50/min; Kalaemia >5.5 mmol/L or <3.5 mmol/L; Ongoing treatment with piperaquine, halofantrine, dasatinib, nilotinib, hydroxyzine, domperidone, citalopram, escitalopram, potent inhibitors or inducers of cytochrome P450 CYP3A4 isoenzyme, repaglinide, azathioprine, 6-mercaptopurine, theophylline, pyrazinamide, warfarin; Known hypersensitivity to any of the trial drugs or to chloroquine and other 4-aminoquinolines, amodiaquine, mefloquine, glafenine, floctafenine, antrafenine, ARB; Hepatic porphyria; Liver failure (Child-Pugh stage ≥B); Stage 4 or 5 chronic kidney disease (GFR <30 mL/min/1.73 m²); Dialysis; Hypersentivity to lactose; Lactase deficiency; Abnormalities in galactose metabolism; Malabsorption syndrome; Glucose-6-phosphate dehydrogenase deficiency; Symptomatic hyperuricemia; Ileus; Colitis; Enterocolitis; Chronic hepatitis B virus disease. The trial is being conducted in France in the Bordeaux, Corse, Dijon, Nancy, Paris and Toulouse areas as well as in the Grand Duchy of Luxembourg. Participants are recruited either at home, nursing homes, general practices, primary care centres or hospital outpatient consultations.
INTERVENTION AND COMPARATOR


The four experimental treatments planned in protocol version 1.2 (April 8 th , 2020) are: (1) Hydroxychloroquine 200 mg, 2 tablets BID on day 0, 2 tablets QD from day 1 to 9; (2) Imatinib 400 mg, 1 tablet QD from day 0 to 9; (3) Favipiravir 200 mg, 12 tablets BID on day 0, 6 tablets BID from day 1 to 9; (4) Telmisartan 20 mg, 1 tablet QD from day 0 to 9. The comparator is a complex of vitamins and trace elements (AZINC Forme et Vitalité®), 1 capsule BID for 10 days, for which there is no reason to believe that they are active on the virus. In protocol version 1.2 (April 8th, 2020): People in the control arm will receive a combination of vitamins and trace elements; people in the experimental arms will receive hydroxychloroquine, or favipiravir, or imatinib, or telmisartan.
MAIN OUTCOME


The primary outcome is the proportion of participants with an incidence of hospitalisation and/or death between inclusion and day 14 in each arm.
RANDOMISATION


Participants are randomized in a 1:1:1:1:1 ratio to each arm using a web-based randomisation tool. Participants not treated with an ARB or ACEI prior to enrolment are randomized to receive the comparator or one of the four experimental drugs. Participants already treated with an ARB or ACEI are randomized to receive the comparator or one of the experimental drugs except telmisartan (i.e.: hydroxychloroquine, imatinib, or favipiravir). Randomisation is stratified on ACEI or ARBs treatment at inclusion and on the type of residence (personal home vs. nursing home).
BLINDING (MASKING)


This is an open-label trial. Participants, caregivers, investigators and statisticians are not blinded to group assignment.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


A total of 1057 participants will be enrolled if all arms are maintained until the final analysis and no additional arm is added. Three successive futility interim analyses are planned, when the number of participants reaches 30, 60 and 102 in the control arm. Two efficacy analyses (interim n°3 and final) will be performed successively.
TRIAL STATUS


This describes the Version 1.2 (April 8 th , 2020) of the COVERAGE protocol that was approved by the French regulatory authority and ethics committee. The trial was opened for enrolment on April 15 th , 2020 in the Nouvelle Aquitaine region (South-West France). Given the current decline of the COVID-19 pandemic in France and its unforeseeable dynamic in the coming months, new trial sites in 5 other French regions and in Luxembourg are currently being opened. A revised version of the protocol was submitted to the regulatory authority and ethics committee on June 15 th , 2020. It contains the following amendments: (i) Inclusion criteria: age ≥65 replaced by age ≥60; time since first symptoms <3 days replaced by time since first symptoms <5 days; (ii) Withdrawal of the hydroxychloroquine arm (due to external data); (iii) increase in the number of trial sites.
TRIAL REGISTRATION


The trial was registered on Clinical Trials.gov on April 22 nd , 2020 (Identifier: NCT04356495): and on EudraCT on April 10 th , 2020 (Identifier: 2020-001435-27).
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"The primary outcome is the proportion of participants with an incidence of hospitalisation and/or death between inclusion and day 14 in each arm.
","['Participants not treated with an ARB or ACEI prior to enrolment', '1057 participants will be enrolled if all arms are maintained until the final analysis and no additional arm is added', 'patients aged 65 or more with recent symptomatic SARS-CoV-2 infection (COVID-19) and no criteria for hospitalisation', 'on April 10 th , 2020 (Identifier: 2020-001435-27', 'Inclusion criteria are: 65-year-old or more; Positive test for SARS-CoV-2 on a nasopharyngeal swab; Symptoms onset within 3 days before diagnosis', 'outpatients aged 65 years or older (COVERAGE trial', 'Older People with Symptomatic SARS-CoV-2 Infection (COVID-19', 'enrolment on April 15 th , 2020 in the Nouvelle Aquitaine region (South-West France', 'QT syndrome; QTc interval > 500 ms; Heart rate <50/min; Kalaemia >5.5 mmol/L or <3.5 mmol/L; Ongoing treatment with piperaquine, halofantrine, dasatinib, nilotinib', 'Participants already treated with an ARB or ACEI', 'Participants are recruited either at home, nursing homes, general practices, primary care centres or hospital outpatient consultations']","['hydroxychloroquine', 'hydroxyzine, domperidone, citalopram, escitalopram, potent inhibitors or inducers of cytochrome P450 CYP3A4 isoenzyme, repaglinide, azathioprine, 6-mercaptopurine, theophylline, pyrazinamide, warfarin', 'hydroxychloroquine, or favipiravir, or imatinib, or telmisartan', 'Hydroxychloroquine', 'chloroquine and other 4-aminoquinolines, amodiaquine, mefloquine, glafenine, floctafenine, antrafenine', 'Telmisartan', 'Multi-Arm Multi-Stage (MAMS', 'telmisartan (i.e.: hydroxychloroquine, imatinib, or favipiravir', 'EudraCT']","['proportion of participants with an incidence of hospitalisation and/or death', 'Risk of Hospitalisation or Death', 'Efficacy and Tolerability', 'hospitalisation or death', 'futility, efficacy or toxicity']","[{'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0120726', 'cui_str': 'halofantrine'}, {'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C1721377', 'cui_str': 'nilotinib'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0020404', 'cui_str': 'Hydroxyzine'}, {'cui': 'C0013015', 'cui_str': 'Domperidone'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0008381', 'cui_str': 'Cholesterol monooxygenase (side-chain cleaving)'}, {'cui': 'C1142644', 'cui_str': 'cytochrome P450 3A4 protein, human'}, {'cui': 'C0022173', 'cui_str': 'Isozymes'}, {'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0039771', 'cui_str': 'Theophylline'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0048060', 'cui_str': '4-aminoquinoline'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0025153', 'cui_str': 'Mefloquine'}, {'cui': 'C0017592', 'cui_str': 'glafenine'}, {'cui': 'C0016245', 'cui_str': 'floctafenine'}, {'cui': 'C0052135', 'cui_str': 'antrafenine'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086322', 'cui_str': 'Futility'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",1057.0,0.200195,"The primary outcome is the proportion of participants with an incidence of hospitalisation and/or death between inclusion and day 14 in each arm.
","[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Duvignaud', 'Affiliation': 'CHU Bordeaux, Department of Infectious Diseases and Tropical Medicine, Division of Tropical Medicine and Clinical International Health, F-33000, Bordeaux, France. alexandre.duvignaud@chu-bordeaux.fr.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Lhomme', 'Affiliation': 'Univ. Bordeaux, Inserm, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Pistone', 'Affiliation': 'CHU Bordeaux, Department of Infectious Diseases and Tropical Medicine, Division of Tropical Medicine and Clinical International Health, F-33000, Bordeaux, France.'}, {'ForeName': 'Racha', 'Initials': 'R', 'LastName': 'Onaisi', 'Affiliation': 'Department of General Practice, Univ. Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Sitta', 'Affiliation': 'Univ. Bordeaux, Inserm, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Journot', 'Affiliation': 'Inserm U1219, Univ. Bordeaux, IRD, F-33000, Bordeaux, France.'}, {'ForeName': 'Duc', 'Initials': 'D', 'LastName': 'Nguyen', 'Affiliation': 'CHU Bordeaux, Department of Infectious Diseases and Tropical Medicine, Division of Tropical Medicine and Clinical International Health, F-33000, Bordeaux, France.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Peiffer-Smadja', 'Affiliation': 'CHU Bichat Claude Bernard, Department of Infectious Diseases and Tropical Medicine, APHP, F-75000, Paris, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Crémer', 'Affiliation': 'Department of Cardiology - Hypertension, CHU Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Bouchet', 'Affiliation': 'Inserm U1219, Univ. Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Darnaud', 'Affiliation': 'Centre Hospitalier de Bastia, Service de Chirurgie Spécialisée & Unité de Recherche Clinique, F-20200, Bastia, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Poitrenaud', 'Affiliation': ""Department of Infectious Diseases and Tropical Medicine, Centre Hospitalier d'Ajaccio, F-20090, Ajaccio, France.""}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Piroth', 'Affiliation': 'Department of Infectious Diseases and Tropical Medicine, CHU Dijon, F-21079, Dijon, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Binquet', 'Affiliation': 'Inserm, CHU Dijon, CIC-EC 1432, F-21000, Dijon, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Michel', 'Affiliation': 'Centre Medical de Steinsel, Steinsel, Luxembourg.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lefèvre', 'Affiliation': 'Department of Infectious Diseases and Tropical Medicine, CHU Nancy, F-54000, Nancy, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lebeaux', 'Affiliation': 'Department of Infectious Diseases and Tropical Medicine, Hôpital Européen Georges Pompidou, APHP, F-75000, Paris, France.'}, {'ForeName': 'Josselin', 'Initials': 'J', 'LastName': 'Lebel', 'Affiliation': 'Department of General Practice, Université de Paris, F-75018, Paris, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dupouy', 'Affiliation': 'MSPU Pins Justaret, F-31860, Pins Justaret, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Roussillon', 'Affiliation': 'Clinical Research and Innovation Department, Safety and vigilance, CHU Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gimbert', 'Affiliation': 'Clinical Research and Innovation Department, CHU Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wittkop', 'Affiliation': 'CHU Bordeaux, Pôle de Santé Publique, F-33000, Bordeaux, France.'}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Thiébaut', 'Affiliation': 'Univ. Bordeaux, Inserm, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Orne-Gliemann', 'Affiliation': 'Inserm U1219, Univ. Bordeaux, IRD, F-33000, Bordeaux, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Joseph', 'Affiliation': 'Department of General Practice, CIC 1401, Univ. Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Richert', 'Affiliation': 'Univ. Bordeaux, Inserm, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Anglaret', 'Affiliation': 'Inserm U1219, Univ. Bordeaux, IRD, F-33000, Bordeaux, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Malvy', 'Affiliation': 'CHU Bordeaux, Department of Infectious Diseases and Tropical Medicine, Division of Tropical Medicine and Clinical International Health, F-33000, Bordeaux, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04619-1']
2540,33050947,An adaptive randomised placebo controlled phase II trial of antivirals for COVID-19 infection (VIRCO): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


Primary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of randomisation Secondary objectives: • To determine the safety of the antiviral • To determine the clinical benefit of the antiviral over placebo according to the WHO 7-point ordinal scale • To determine the clinical benefit of the antiviral over placebo on time to resolution of clinical symptoms • To determine the effect of the antiviral over placebo on biomarkers of inflammation and immune activation TRIAL DESIGN: This is a multi-centre, triple-blind, randomised placebo controlled phase II, 2-arm trial with parallel-group design with allocation ratio 1:1.
PARTICIPANTS


Inclusion Criteria: • Provision of informed consent by the participant • Age ≥18 years • Confirmed SARS-CoV-2 by nucleic acid testing in the past 5 days • COVID-19 related symptom initiation within 5 days • Female patients of childbearing potential must have a negative pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 1 week following the last dose of study treatment.
EXCLUSION CRITERIA


• Known allergy to the study medication • Is on another clinical trial investigating an antiviral treatment for COVID-19 • Pregnancy • Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification • Patients with renal impairment requiring dialysis • Is deemed by the Investigator to be ineligible for any reason Participants will be recruited from, and the study visits will take place at Alfred Hospital, Monash Health, Austin Health in Victoria, Australia for hospitalised participants as well as recruitment in the community in participants homes for eligible people not requiring hospitalisation.
INTERVENTION AND COMPARATOR


The first candidate antiviral is favipiravir Arm 1: Favipiravir 1800 mg favipiravir BD on Day 1 followed by 800 mg BD favipiravir for the next 13 days. Arm 2: Placebo MAIN OUTCOMES: Primary outcome: Time to virological cure as defined by 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing during the 14 days after enrolment.
RANDOMISATION


Randomisation performed at the Alfred Hospital Clinical Trials Pharmacy using computer generated block-randomisation lists with 6 participants per block. Within each block half of the participants will be randomised to the candidate antiviral and the other half to placebo. Randomisation is stratified by study site, with participants enrolled in the community considered as a study site.
BLINDING (MASKING)


Study participants, study investigators and the study statistician will be blinded to treatment allocation.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The study aims to recruit 190 people (95/arm) with the first candidate antiviral favipiravir TRIAL STATUS: Protocol version 2.0 Dated 31-Jul-2020. Recruitment will take place between July 2020 and December 2020.
TRIAL REGISTRATION


clinicaltrials.gov NCT04445467 First posted 24-Jun-2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,The study aims to recruit 190 people (95/arm) with the first candidate antiviral favipiravir TRIAL STATUS:,"['COVID-19 infection (VIRCO', 'Inclusion Criteria: • Provision of informed consent by the participant • Age ≥18 years •', 'participants homes for eligible people not requiring hospitalisation', '190 people (95/arm) with the first candidate antiviral favipiravir TRIAL STATUS', 'Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential', 'COVID-19 • Pregnancy • Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification •', 'participants enrolled in the community considered as a study site', 'Patients with renal impairment requiring dialysis •', 'Female patients of childbearing potential']","['antiviral •', '24-Jun-2020', 'placebo', 'Placebo', 'Favipiravir 1800 mg favipiravir BD']","['WHO 7-point ordinal scale •', 'Time to virological cure as defined by 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0441807', 'cui_str': 'Grade C'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]","[{'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0162508', 'cui_str': 'jun Oncogene'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}]","[{'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0200932', 'cui_str': 'Nucleic acid amplification'}]",,0.508829,The study aims to recruit 190 people (95/arm) with the first candidate antiviral favipiravir TRIAL STATUS:,"[{'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'McMahon', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia. james.mcmahon@monash.edu.'}, {'ForeName': 'Jillian S Y', 'Initials': 'JSY', 'LastName': 'Lau', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Roney', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Rogers', 'Affiliation': 'Department of Infectious Diseases, Monash Medical Centre, Melbourne, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Trubiano', 'Affiliation': 'Department of Infectious Diseases, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Sasadeusz', 'Affiliation': 'Department of Infectious Diseases, Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Molton', 'Affiliation': 'Department of Infectious Diseases, Western Health, Melbourne, Australia.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Gardiner', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Sue J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Hoy', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Cheng', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Anton Y', 'Initials': 'AY', 'LastName': 'Peleg', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}]",Trials,['10.1186/s13063-020-04766-5']
2541,33050952,Adjuvant psychotherapy in early-stage bipolar disorder: study protocol for a randomized controlled trial.,"BACKGROUND


Bipolar disorders are serious illnesses with a chronic course and a high rate of relapse. Typically, bipolar disorders onset during adolescence or early adulthood, with patients experiencing significant personal and social costs as a consequence of their illness. Despite this, to date, there is limited (controlled) evidence regarding the effectiveness of psychotherapy during the critical stages of the disorder (e.g., early onset). Some preliminary studies suggest that targeted, tailored early interventions in particular may improve disease prognosis. The proposed study examines the effectiveness of group psychotherapy on relapse prevention, global adaptive functioning, and neuropsychological functioning in early-stage bipolar disorder.
METHODS


In this multicenter randomized controlled trial (RCT), 300 patients with bipolar disorder are randomized to one of two group psychotherapies: Specific Emotional-Cognitive Therapy (SECT; intervention group) or Emotion-Focused Supportive Therapy (EFST; active control group). Each therapy comprises of a total of 48-h sessions (delivered once a month) over a period of 4 months. Assessments take place at baseline (t1); 6 months follow-up, i.e., post-intervention (t2); 12 months follow-up (t3); and 18 months follow-up (t4), whereby 18 months follow-up is the primary time point of interest.
DISCUSSION


The goal of this study is to test the effects of an innovative, specific group therapy relative to an active control condition in terms of rates of relapse, global functioning, and neuropsychological functioning. Pending the outcomes of the trial, it will be possible to establish a firm evidence base for accessible group psychotherapy adjuvant to routine psychiatric care for individuals with bipolar disorder.
TRIAL REGISTRATION


USA: ClinicalTrials.gov NCT02506322 . Registered on 19 December 2014; Germany: German Clinical Trials Register DRKS00006013 . Registered on21 May 2015.",2020,"The proposed study examines the effectiveness of group psychotherapy on relapse prevention, global adaptive functioning, and neuropsychological functioning in early-stage bipolar disorder.
","['300 patients with bipolar disorder', 'early-stage bipolar disorder', 'individuals with bipolar disorder']","['Adjuvant psychotherapy', 'psychotherapies: Specific Emotional-Cognitive Therapy (SECT; intervention group) or Emotion-Focused Supportive Therapy (EFST; active control group']","['rates of relapse, global functioning, and neuropsychological functioning', 'relapse prevention, global adaptive functioning, and neuropsychological functioning']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}]",300.0,0.28574,"The proposed study examines the effectiveness of group psychotherapy on relapse prevention, global adaptive functioning, and neuropsychological functioning in early-stage bipolar disorder.
","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Stamm', 'Affiliation': 'Department of Clinical Psychiatry and Psychotherapy, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany. thomas.stamm@mhb-fontane.de.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Zwick', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Clinical Psychiatry and Psychotherapy, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany.'}, {'ForeName': 'Lene-Marie', 'Initials': 'LM', 'LastName': 'Sondergeld', 'Affiliation': 'Department of Clinical Psychiatry and Psychotherapy, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hautzinger', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, University of Tübingen, Tübingen, Germany.'}]",Trials,['10.1186/s13063-020-04755-8']
2542,33050974,Enhancing the potential effects of text messages delivered via an m-health intervention to improve packing of healthy school lunchboxes.,"OBJECTIVE


The aim of the study was to assess the impact of different lunchbox messages on parents' intention to pack a healthy lunchbox.
DESIGN


This study employed an experimental design.
PARTICIPANTS


Parents of primary school-aged children were randomised to receive different messages to encourage the packing of healthy lunchboxes.
SETTING


A series of messages were developed to align with the six constructs of the Health Belief Model (HBM). Messages were also developed which were (and were not) personalised and varied based on the source of the information provided (university, school, dietitian, health promotion service). During a telephone survey, participants were read the content of each message, and asked about their intention to pack a healthy lunchbox.
RESULTS


The study was completed by 511 parents. Linear mixed regression analyses identified significant differences (p<0.05) in intention scores between variant messages targeting the same behavioural constructs for 'susceptibility', 'severity', 'benefits', and 'barriers' but not 'cues to action' or 'self-efficacy'. The highest mean behavioural intention score was for 'benefits' whilst the lowest mean score was 'barriers'. There were no significant differences in intention scores of parents receiving messages from a dietitian, university, health promotion team or school (p=0.37). Intention scores did not differ in which messages were personalised based on child's name (p=0.84) or grade level (p=0.54).
CONCLUSIONS


The findings suggest that messages that focus on the benefits of packing healthy lunchboxes may be particularly useful in improving intentions of parents to pack healthy foods for their children to consume at school.",2020,"There were no significant differences in intention scores of parents receiving messages from a dietitian, university, health promotion team or school (p=0.37).","['511 parents', 'Parents of primary school-aged children', 'healthy school lunchboxes', ""parents' intention to pack a healthy lunchbox""]","['lunchbox messages', 'text messages delivered via an m-health intervention']","['Intention scores', ""susceptibility', 'severity', 'benefits', and 'barriers' but not 'cues to action' or 'self-efficacy"", 'intention scores', 'highest mean behavioural intention score']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0747996,"There were no significant differences in intention scores of parents receiving messages from a dietitian, university, health promotion team or school (p=0.37).","[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, CallaghanNSW2308, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sutherland', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, CallaghanNSW2308, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Janssen', 'Affiliation': 'Hunter New England Population Health, WallsendNSW2287, Australia.'}, {'ForeName': 'Nayerra', 'Initials': 'N', 'LastName': 'Hudson', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, CallaghanNSW2308, Australia.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Chooi', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, CallaghanNSW2308, Australia.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Reynolds', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, CallaghanNSW2308, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Walton', 'Affiliation': 'Mid North Coast Local Health District Health Promotion, 119 River Street, Kempsey, NSW2440, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, CallaghanNSW2308, Australia.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Reilly', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, CallaghanNSW2308, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Nathan', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, CallaghanNSW2308, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, CallaghanNSW2308, Australia.'}]",Public health nutrition,['10.1017/S1368980020003997']
2543,33051032,The Influence of Hair Pulling Styles in the Treatment of Trichotillomania.,"This report investigated the improvement in Automatic and Focused styles of hair pulling among youth with trichotillomania (TTM). Youth with TTM (N = 40) participated in a clinical trial that compared habit reversal training (HRT) to treatment-as-usual (TAU). Participants completed a baseline assessment to characterize hair pulling severity, self-reported hair pulling styles, and co-occurring psychiatric conditions. Youth were randomly assigned to receive eight weekly sessions of HRT or eight weeks of TAU. Afterward, youth completed a post-treatment assessment of hair pulling severity and hair pulling styles. Youth in the TAU condition then received eight weekly sessions of HRT and completed another post-treatment assessment. Analyses revealed that the Focused pulling style largely improved with HRT (d = 0.73) compared to TAU (d = 0.11). However, there was limited improvement for the Automatic pulling style following either HRT (d = 0.10) or TAU (d = -0.31). This same pattern of effects was also found during open-label treatment with HRT. Although behavior therapies such as HRT are the principle treatment for youth with TTM, the Automatic pulling style exhibited limited improvement to this therapeutic approach. Therefore, therapeutic strategies that enhance awareness to pulling behaviors may produce more robust outcomes to behavior therapy for youth with TTM.",2020,Analyses revealed that the Focused pulling style largely improved with HRT (d = 0.73) compared to TAU (d = 0.11).,"['hair pulling among youth with trichotillomania (TTM', 'Youth with TTM (N = 40) participated in a clinical trial that compared']","['habit reversal training (HRT) to treatment-as-usual (TAU', 'HRT or eight weeks of TAU']","['Automatic pulling style', 'hair pulling severity and hair pulling styles']","[{'cui': 'C0040953', 'cui_str': 'Trichotillomania'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0040953', 'cui_str': 'Trichotillomania'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",40.0,0.052226,Analyses revealed that the Focused pulling style largely improved with HRT (d = 0.73) compared to TAU (d = 0.11).,"[{'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'McGuire', 'Affiliation': 'Johns Hopkins University School of Medicine. Electronic address: jfmcguire@jhmi.edu.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Myers', 'Affiliation': 'Johns Hopkins University School of Medicine.'}, {'ForeName': 'Adam B', 'Initials': 'AB', 'LastName': 'Lewin', 'Affiliation': 'University of South Florida.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Baylor College of Medicine.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Rahman', 'Affiliation': 'University of South Florida.'}]",Behavior therapy,['10.1016/j.beth.2019.12.003']
2544,33051035,Exploring the Effects of the Mindfulness and Countering Emotional Behaviors Modules From the Unified Protocol on Dysregulated Anger in the Context of Emotional Disorders.,"Dysregulated anger in the context of emotional (e.g., mood, anxiety, related) disorders is associated with treatment attrition and a lower likelihood of responding to extant treatments. Therefore, there is a need to identify the most effective skills for targeting this anger and prioritize their delivery in treatment with the hope of producing more potent interventions. The current study explored the specific effects of two treatment skills (mindfulness and countering emotional behaviors) in isolation and combination as interventions for dysregulated anger using single-case experimental design. Patients were randomized to a 2- or 4-week baseline with no intervention applied and then to the first treatment skill received. All patients subsequently completed the alternate treatment skill and 1 month of follow-up. Results suggested the first module had clinically meaningful effects for five patients and the second module produced incremental improvement for five patients. Visual inspection and effect sizes indicated mindfulness produced greater reductions in anger when delivered in isolation compared to countering emotional behaviors (d = 0.96, 0.33, for mindfulness and countering emotional behaviors, respectively). With regard to the second module, more patients (n = 4) experienced a reduction in anger in response to mindfulness than to countering emotional behaviors (n = 1); effect sizes indicated significant improvements in response to both modules (d = 0.83, 0.72, for mindfulness and countering emotional behaviors, respectively). Taken together, results suggest mindfulness may be a more efficacious intervention for anger than countering emotional behaviors. Implications of these results for addressing dysregulated anger in treatment are discussed.",2020,"Visual inspection and effect sizes indicated mindfulness produced greater reductions in anger when delivered in isolation compared to countering emotional behaviors (d = 0.96, 0.33, for mindfulness and countering emotional behaviors, respectively).",[],[],['emotional behaviors'],[],[],"[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0221472,"Visual inspection and effect sizes indicated mindfulness produced greater reductions in anger when delivered in isolation compared to countering emotional behaviors (d = 0.96, 0.33, for mindfulness and countering emotional behaviors, respectively).","[{'ForeName': 'Clair', 'Initials': 'C', 'LastName': 'Cassiello-Robbins', 'Affiliation': 'Boston University. Electronic address: ccassiel@bu.edu.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Sauer-Zavala', 'Affiliation': 'University of Kentucky.'}, {'ForeName': 'Leslie R', 'Initials': 'LR', 'LastName': 'Brody', 'Affiliation': 'Boston University.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Boston University.'}]",Behavior therapy,['10.1016/j.beth.2019.12.007']
2545,33051037,"Two Trajectories of Depressive Symptom Reduction Throughout Behavioral Activation Teletherapy Among Underserved, Ethnically Diverse, Primary Care Patients: A VitalSign 6  Report.","While prior research has investigated trajectories of depressive symptom change throughout psychotherapy, such work has not been conducted exclusively among underserved patients receiving brief Behavioral Activation (BA) teletherapy, intervention modifications that should reduce barriers to therapy initiation and engagement. The current project used cluster analysis to determine discrete groups of symptom change among patients receiving an 8-session BA teletherapy intervention, and analyzed whether demographic and clinical characteristics were associated with group membership. Data from 105 patients referred from charity primary care clinics and receiving at least two therapy sessions were analyzed. Patients were predominantly female and Latina. The 9-item Patient Health Questionnaire (PHQ-9) was the outcome. Two categories were determined: a larger group (N = 61) demonstrating initially less severe symptoms and experiencing a gradual recovery, and a smaller group beginning with more severe symptoms, and experiencing a steeper recovery. In both groups, a majority of participants experienced at least a 5-point drop in depressive symptoms, while in the latter group, a majority of patients achieved depressive symptom remission (PHQ-9 < 5). Monolingual Spanish speakers were more likely to be in the former group, but no other demographic or clinical characteristics were associated with group membership. In both groups, a majority of the symptom reduction occurred by sessions 4-6. Therefore, two categories of depressive symptom change, slow responders and rapid responders, occur among patients receiving a brief BA teletherapy intervention. No demographic differences aside from primary language, nor any clinical characteristics, distinguish group membership, suggesting similar patterns of symptom reduction among a primarily underserved sample.",2020,"No demographic differences aside from primary language, nor any clinical characteristics, distinguish group membership, suggesting similar patterns of symptom reduction among a primarily underserved sample.","['underserved patients receiving', 'Patients were predominantly female and Latina', '105 patients referred from charity primary care clinics and receiving at least two therapy sessions were analyzed']","['8-session BA teletherapy intervention', 'brief Behavioral Activation (BA) teletherapy', 'Teletherapy', 'brief BA teletherapy intervention']","['severe symptoms and experiencing a gradual recovery', 'Depressive Symptom Reduction', 'Behavioral Activation', 'depressive symptom remission', '9-item Patient Health Questionnaire (PHQ-9', 'depressive symptoms', 'symptom reduction']","[{'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0007962', 'cui_str': 'Charities'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",105.0,0.0226986,"No demographic differences aside from primary language, nor any clinical characteristics, distinguish group membership, suggesting similar patterns of symptom reduction among a primarily underserved sample.","[{'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Trombello', 'Affiliation': 'University of Texas Southwestern Medical Center. Electronic address: Joseph.Trombello@utsouthwestern.edu.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'South', 'Affiliation': 'Southern Methodist University.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Sánchez', 'Affiliation': 'Los Barrios Unidos Community Clinic.'}, {'ForeName': 'Farra', 'Initials': 'F', 'LastName': 'Kahalnik', 'Affiliation': 'University of Texas Southwestern Medical Center.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kennard', 'Affiliation': 'University of Texas Southwestern Medical Center.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern Medical Center.'}]",Behavior therapy,['10.1016/j.beth.2020.01.002']
2546,33051038,Isolating the Effects of Mindfulness Training Across Anxiety Disorder Diagnoses in the Unified Protocol.,"The Unified Protocol for Transdiagnostic Treatment (UP; Barlow et al., 2011) has recently demonstrated statistically equivalent therapeutic effects compared to leading cognitive behavioral therapy (CBT) protocols for anxiety disorders designed to address disorder-specific symptoms (i.e., single-disorder protocols [SDP]); Barlow et al., 2017). Although all treatment protocols included similar evidence-based CBT elements, investigation of those related to symptom improvement in the UP is warranted. Because the UP is unique from the SDPs for its inclusion of mindfulness, the present study evaluated mindfulness as a primary treatment element. We explored whether UP participants, compared to SDP, demonstrated greater improvements in mindfulness from pre- to posttreatment, and whether these improvements predicted posttreatment severity across anxiety disorder diagnoses. Participants were individuals with a principle anxiety disorder (N = 179) randomized to receive either the UP or SDP. Results indicated significant improvements pre- to posttreatment in mindfulness for participants receiving either the UP or SDP. However, at posttreatment, mindfulness scores were significantly greater for the UP condition. At the diagnosis level, posttreatment scores in mindfulness were significantly greater in the UP condition than the respective SDP conditions for principal Generalized Anxiety Disorder (GAD) and Social Anxiety Disorder (SOC). Moreover, results suggest that change in mindfulness is related to posttreatment severity, when moderated by treatment condition, but only for participants with principal GAD. Taken together, the UP is effective in improving mindfulness in a sample with heterogeneous anxiety disorders, but this change seems particularly relevant for reduction in symptom severity for individuals with principal GAD.",2020,"At the diagnosis level, posttreatment scores in mindfulness were significantly greater in the UP condition than the respective SDP conditions for principal Generalized Anxiety Disorder (GAD) and Social Anxiety Disorder (SOC).",['Participants were individuals with a principle anxiety disorder (N = 179'],"['Mindfulness Training', 'cognitive behavioral therapy (CBT) protocols', 'UP or SDP']","['principal Generalized Anxiety Disorder (GAD) and Social Anxiety Disorder (SOC', 'mindfulness scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C4517609', 'cui_str': '179'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",179.0,0.0123454,"At the diagnosis level, posttreatment scores in mindfulness were significantly greater in the UP condition than the respective SDP conditions for principal Generalized Anxiety Disorder (GAD) and Social Anxiety Disorder (SOC).","[{'ForeName': 'Brittany K', 'Initials': 'BK', 'LastName': 'Woods', 'Affiliation': 'Boston University. Electronic address: bkwoods@bu.edu.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Sauer-Zavala', 'Affiliation': 'Boston University.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Farchione', 'Affiliation': 'Boston University.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Boston University.'}]",Behavior therapy,['10.1016/j.beth.2020.01.001']
2547,33051039,Effects of Mindfulness-Based Stress Reduction on Psychological Symptoms and Telomere Length: A Randomized Active-Controlled Trial.,"Much research has demonstrated the beneficial effects of mindfulness-based stress reduction (MBSR) on psychological and physical health, but it is not known whether MBSR may impact cellular aging in healthy populations. Further, little research has evaluated MBSR against an active control condition, which precludes strong conclusions regarding the unique effects of mindfulness on psychological functioning. The present study examined the effects of MBSR versus music therapy-based stress reduction (MTSR) on trait mindfulness, self-compassion, and several psychological health outcomes, as well as leukocyte telomere length (LTL). One hundred and fifty eight Singaporean Chinese adults were recruited and randomly assigned to an eight-week MBSR or MTSR course. Participants provided blood samples and completed a battery of self-report measures pre- and post-intervention. Analyses showed that participants in the MBSR condition demonstrated significantly greater improvements in depressive symptoms, trait mindfulness, and self-compassion compared to the control condition. Treatment condition did not predict changes in LTL, anxiety, stress, or happiness, though there was a trend for duration of home mindfulness practice to predict increases in LTL. Overall, the study demonstrated MBSR's unique effects in reducing depressive symptoms. Improvements in trait mindfulness and self-compassion correspond with theorized mechanisms of change underlying mindfulness training. The lack of intervention effect with regards to LTL suggests that a more intensive intervention may be required for mindfulness to exert noticeable impact on aging at the cellular level, or that the effect may only emerge over a longer term.",2020,"Analyses showed that participants in the MBSR condition demonstrated significantly greater improvements in depressive symptoms, trait mindfulness, and self-compassion compared to the control condition.","['One hundred and fifty eight Singaporean Chinese adults', 'healthy populations']","['MBSR versus music therapy-based stress reduction (MTSR', 'Mindfulness-Based Stress Reduction']","['depressive symptoms, trait mindfulness, and self-compassion', 'LTL, anxiety, stress, or happiness', 'Psychological Symptoms and Telomere Length', 'depressive symptoms', 'leukocyte telomere length (LTL', 'trait mindfulness, self-compassion, and several psychological health outcomes', 'trait mindfulness and self-compassion']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",158.0,0.0157334,"Analyses showed that participants in the MBSR condition demonstrated significantly greater improvements in depressive symptoms, trait mindfulness, and self-compassion compared to the control condition.","[{'ForeName': 'Shian-Ling', 'Initials': 'SL', 'LastName': 'Keng', 'Affiliation': 'Yale-NUS College, Singapore. Electronic address: kengsl@yale-nus.edu.sg.'}, {'ForeName': 'Pei Shan', 'Initials': 'PS', 'LastName': 'Looi', 'Affiliation': 'National University of Singapore, Singapore.'}, {'ForeName': 'Elysia Li Yan', 'Initials': 'ELY', 'LastName': 'Tan', 'Affiliation': 'National University of Singapore, Singapore.'}, {'ForeName': 'Onn-Siong', 'Initials': 'OS', 'LastName': 'Yim', 'Affiliation': 'National University of Singapore, Singapore.'}, {'ForeName': 'Poh San', 'Initials': 'PS', 'LastName': 'Lai', 'Affiliation': 'National University of Singapore, Singapore.'}, {'ForeName': 'Soo Hong', 'Initials': 'SH', 'LastName': 'Chew', 'Affiliation': 'National University of Singapore, Singapore.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Ebstein', 'Affiliation': 'China Center for Behavior Economics and Finance, South Western University of Finance and Economics, China. Electronic address: rpebstein@gmail.com.'}]",Behavior therapy,['10.1016/j.beth.2020.01.005']
2548,33051044,Taurine supplementation associated with exercise increases mitochondrial activity and fatty acid oxidation gene expression in the subcutaneous white adipose tissue of obese women.,"PURPOSE


To evaluate the effects of taurine supplementation associated or not with chronic exercise on body composition, mitochondrial function, and expression of genes related to mitochondrial activity and lipid oxidation in the subcutaneous white adipose tissue (scWAT) of obese women.
METHODS


A randomized and double-blind trial was developed with 24 obese women (BMI 33.1 ± 2.9 kg/m 2 , 32.9 ± 6.3 y) randomized into three groups: Taurine supplementation group (Tau, n = 8); Exercise group (Ex, n = 8); Taurine supplementation + exercise group (TauEx, n = 8). The intervention was composed of 3 g of taurine or placebo supplementation and exercise training for eight weeks. Anthropometry, body fat composition, indirect calorimetry, scWAT biopsy for mitochondrial respiration, and gene expression related to mitochondrial activity and lipid oxidation were assessed before and after the intervention.
RESULTS


No changes were observed for the anthropometric characteristics. The Ex group presented an increased resting energy expenditure rate, and the TauEx and Ex groups presented increased lipid oxidation and a decreased respiratory quotient. Both trained groups (TauEx and Ex) demonstrated improved scWAT mitochondrial respiratory capacity. Regarding mitochondrial markers, no changes were observed for the Tau group. The TauEx group had higher expression of CIDEA, PGC1a, PRDM16, UCP1, and UCP2. The genes related to fat oxidation (ACO2 and ACOX1) were increased in the Tau and Ex groups, while only the TauEx group presented increased expression of CPT1, PPARa, PPARγ, LPL, ACO1, ACO2, HSL, ACOX1, and CD36 genes.
CONCLUSION


Taurine supplementation associated with exercise improved lipid metabolism through the modulation of genes related to mitochondrial activity and fatty acid oxidation, suggesting a browning effect in the scWAT of obese women.",2020,"The genes related to fat oxidation (ACO2 and ACOX1) were increased in the Tau and Ex groups, while only the TauEx group presented increased expression of CPT1, PPARa, PPARγ, LPL, ACO1, ACO2, HSL, ACOX1, and CD36 genes.
","['obese women', '24 obese women (BMI 33.1\xa0±\xa02.9\xa0kg/m 2 , 32.9\xa0±\xa06.3']","['taurine or placebo supplementation and exercise training', 'Taurine supplementation group (Tau, n\xa0=\xa08); Exercise group (Ex, n\xa0=\xa08); Taurine supplementation\xa0+\xa0exercise group (TauEx, n\xa0=\xa08', 'Taurine supplementation', 'taurine supplementation']","['fat oxidation (ACO2 and ACOX1', 'resting energy expenditure rate', 'higher expression of CIDEA, PGC1a, PRDM16, UCP1, and UCP2', 'expression of CPT1, PPARa, PPARγ, LPL, ACO1, ACO2, HSL, ACOX1, and CD36 genes', 'lipid metabolism', 'mitochondrial activity and fatty acid oxidation gene expression', 'lipid oxidation and a decreased respiratory quotient', 'Anthropometry, body fat composition, indirect calorimetry, scWAT biopsy for mitochondrial respiration, and gene expression related to mitochondrial activity and lipid oxidation', 'body composition, mitochondrial function, and expression of genes related to mitochondrial activity and lipid oxidation', 'scWAT mitochondrial respiratory capacity']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C4319697', 'cui_str': '6.3'}]","[{'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0023816', 'cui_str': 'Lipoprotein lipase'}, {'cui': 'C0054954', 'cui_str': 'Lymphocyte antigen CD36'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1704223', 'cui_str': 'White Adipose Tissue'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",24.0,0.0708696,"The genes related to fat oxidation (ACO2 and ACOX1) were increased in the Tau and Ex groups, while only the TauEx group presented increased expression of CPT1, PPARa, PPARγ, LPL, ACO1, ACO2, HSL, ACOX1, and CD36 genes.
","[{'ForeName': 'Flavia Giolo', 'Initials': 'FG', 'LastName': 'De Carvalho', 'Affiliation': 'School of Physical Education and Sport of Ribeirao Preto, University of Sao Paulo -EEFERP USP, Ribeirao Preto, Sao Paulo, Brazil.'}, {'ForeName': 'Camila Fernanda Cunha', 'Initials': 'CFC', 'LastName': 'Brandao', 'Affiliation': 'Internal Medicine Department, Ribeirao Preto Medical School, University of Sao Paulo - FMRP USP, Ribeirao Preto, Sao Paulo, Brazil; State University of Minas Gerais - UEMG, Divinopolis, Minas Gerais, Brazil.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Batitucci', 'Affiliation': 'Department of Food and Nutrition, School of Pharmaceutical Sciences of Araraquara, State University of Sao Paulo - FCF UNESP, Araraquara, Sao Paulo, Brazil.'}, {'ForeName': 'Anderson de Oliveira', 'Initials': 'AO', 'LastName': 'Souza', 'Affiliation': 'Department of BioMolecular Sciences, Faculty of Pharmaceutical Sciences of Ribeirao Preto, University of Sao Paulo - FCFRP USP, Ribeirao Preto, Sao Paulo, Brazil.'}, {'ForeName': 'Gustavo Duarte', 'Initials': 'GD', 'LastName': 'Ferrari', 'Affiliation': 'Department of BioMolecular Sciences, Faculty of Pharmaceutical Sciences of Ribeirao Preto, University of Sao Paulo - FCFRP USP, Ribeirao Preto, Sao Paulo, Brazil.'}, {'ForeName': 'Luciane Carla', 'Initials': 'LC', 'LastName': 'Alberici', 'Affiliation': 'Department of BioMolecular Sciences, Faculty of Pharmaceutical Sciences of Ribeirao Preto, University of Sao Paulo - FCFRP USP, Ribeirao Preto, Sao Paulo, Brazil.'}, {'ForeName': 'Vitor Rosetto', 'Initials': 'VR', 'LastName': 'Muñoz', 'Affiliation': 'Laboratory of Molecular Biology of Exercise, University of Campinas - FCA UNICAMP, Limeira, Sao Paulo, Brazil.'}, {'ForeName': 'José Rodrigo', 'Initials': 'JR', 'LastName': 'Pauli', 'Affiliation': 'Laboratory of Molecular Biology of Exercise, University of Campinas - FCA UNICAMP, Limeira, Sao Paulo, Brazil.'}, {'ForeName': 'Leandro Pereira', 'Initials': 'LP', 'LastName': 'De Moura', 'Affiliation': 'Laboratory of Molecular Biology of Exercise, University of Campinas - FCA UNICAMP, Limeira, Sao Paulo, Brazil.'}, {'ForeName': 'Eduardo Rochete', 'Initials': 'ER', 'LastName': 'Ropelle', 'Affiliation': 'Laboratory of Molecular Biology of Exercise, University of Campinas - FCA UNICAMP, Limeira, Sao Paulo, Brazil.'}, {'ForeName': 'Adelino Sanchez Ramos', 'Initials': 'ASR', 'LastName': 'da Silva', 'Affiliation': 'School of Physical Education and Sport of Ribeirao Preto, University of Sao Paulo -EEFERP USP, Ribeirao Preto, Sao Paulo, Brazil.'}, {'ForeName': 'Marcia Varella Morandi', 'Initials': 'MVM', 'LastName': 'Junqueira-Franco', 'Affiliation': 'Internal Medicine Department, Ribeirao Preto Medical School, University of Sao Paulo - FMRP USP, Ribeirao Preto, Sao Paulo, Brazil.'}, {'ForeName': 'Julio Sergio', 'Initials': 'JS', 'LastName': 'Marchini', 'Affiliation': 'Internal Medicine Department, Ribeirao Preto Medical School, University of Sao Paulo - FMRP USP, Ribeirao Preto, Sao Paulo, Brazil.'}, {'ForeName': 'Ellen Cristini', 'Initials': 'EC', 'LastName': 'de Freitas', 'Affiliation': 'School of Physical Education and Sport of Ribeirao Preto, University of Sao Paulo -EEFERP USP, Ribeirao Preto, Sao Paulo, Brazil; Department of Food and Nutrition, School of Pharmaceutical Sciences of Araraquara, State University of Sao Paulo - FCF UNESP, Araraquara, Sao Paulo, Brazil. Electronic address: ellenfreitas@usp.br.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.09.044']
2549,33051215,Randomised controlled pilot trial comparing low dose and very low- dose microdrop administration of phenylephrine and cyclopentolate for retinopathy of prematurity eye examinations in neonates.,"AIMS


To determine ifVery low dose mydriatic eye microdrop regimen sufficiently dilates the pupil (above 4.1 mm) compared with the currently used low dose mydriatic eye microdrop regimen.Cardiovascular, gastrointestinal and respiratory adverse effects occur following eye drop instillation.
METHODS


Seventeen premature infants were recruited into this prospective, randomised controlled pilot trial in January 2017 to November 2018. Data were collected from the single-centre Neonatal Intensive Care Unit, Dunedin Hospital, New Zealand. The inclusion criteria were birth weight less than 1500 g or gestational age less than 31 weeks, or any premature infant requiring red reflex testing. Infants were randomised to receive either phenylephrine 1% or 0.5% and cyclopentolate 0.2% or 0.1%, 1 microdrop in both eyes. Efficacy outcome measures were pupil size at retinopathy of prematurity eye examination (ROPEE) and ophthalmologist rating of ease of screen.
RESULTS


All participants had sufficient pupillary dilation for a successful ROPEE. Ophthalmologists rated the ROPEE as easy for 90% of all examinations. Pupil dilation measurements at the time of examination, mean±SD, 4.8±0.2 (95% CI 4.5 to 5.2) mm for treatment A and 5±0.2 (95%CI 4.6 to 5.4) mm for treatment B (p=0.61). There were no statistically significant differences between the groups for safety data.
CONCLUSIONS


Very low dose microdrop administration of phenylephrine and cyclopentolate appears to be effective at sufficiently dilating the neonatal pupil for ROPEEs. Low dose and very low dose microdrop mydriatic regimens may also reduce the risk of unwanted adverse effects associated with these medicines.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (reference ACTRN12616001266459p).",2020,"There were no statistically significant differences between the groups for safety data.
","['The inclusion criteria were birth weight less than 1500\u2009g or gestational', 'All participants had sufficient pupillary dilation for a successful ROPEE', 'Seventeen premature infants', 'retinopathy of prematurity eye examinations in neonates', 'age less than 31 weeks, or any premature infant requiring red reflex testing']","['cyclopentolate', 'phenylephrine and cyclopentolate', 'phenylephrine']","['Cardiovascular, gastrointestinal and respiratory adverse effects', 'safety data', 'Pupil dilation measurements', 'pupil size at retinopathy of prematurity eye examination (ROPEE) and ophthalmologist rating of ease of screen']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0026961', 'cui_str': 'Dilated pupil'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0278244', 'cui_str': 'Red reflex'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0010582', 'cui_str': 'Cyclopentolate'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026961', 'cui_str': 'Dilated pupil'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C1704292', 'cui_str': 'Ophthalmologist'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",17.0,0.37693,"There were no statistically significant differences between the groups for safety data.
","[{'ForeName': 'Lisa Jean', 'Initials': 'LJ', 'LastName': 'Kremer', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin, New Zealand lisa.kremer@otago.ac.nz.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Broadbent', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Medlicott', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Sime', 'Affiliation': 'Ophthalmology, Southern District Health Board, Dunedin, New Zealand.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'McCaffrey', 'Affiliation': 'Neonatal Intensive Care Unit, Dunedin Hospital, Dunedin, New Zealand.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Reith', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}]",Archives of disease in childhood,['10.1136/archdischild-2019-318733']
2550,33051226,PREventive effect of FENestration with and without clipping on post-kidney transplantation lymphatic complications (PREFEN): study protocol for a randomised controlled trial.,"INTRODUCTION


Peritoneal fenestration is an effective preventive method for reducing the rate of lymphatic complications in kidney transplantation (KTx). The size of the fenestration plays an important role in its effectiveness. A large peritoneal window is no longer indicated, due to herniation and difficulties in performing biopsies. Small preventive fenestration is effective but will be closed too early. The aim of this study is to evaluate whether metal clips around the edges of a small fenestration result in optimal effects with minimum fenestration size.
METHODS AND ANALYSIS


This trial has been initiated in July 2019 and is expected to last for 2 and a half years. All patients older than 18 years, who receive kidneys from deceased donors, will be included. The kidney recipients will be randomly allocated to either a control arm (small fenestration alone) or an intervention arm (small fenestration with clipping). All fenestrations will be round, maximum 2 cm, and close to the kidney hilum. Clipping will be performed with eight metal clips around the peritoneal window (360°) in every 45° in an oblique position. The primary endpoint is the incidence of symptomatic post-KTx lymphatic complications, which require interventional treatment within 6 months after KTx. Secondary endpoints are intraoperative and postoperative outcomes, including blood loss, operation time, severity grade of lymphocele/lymphorrhea and relative symptoms.
ETHICS AND DISSEMINATION


This protocol study received approval from the Ethics Committee of the University of Heidelberg (Registration Number S-318/2017). A Standard Protocol Items: Recommendations for Interventional Trials checklist is available for this protocol. The results will be disseminated through peer-reviewed journals and conference presentations.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03682627).",2020,"INTRODUCTION


Peritoneal fenestration is an effective preventive method for reducing the rate of lymphatic complications in kidney transplantation (KTx).","['kidney transplantation (KTx', 'All patients older than 18 years, who receive kidneys from deceased donors, will be included', 'post-kidney transplantation lymphatic complications (PREFEN']","['control arm (small fenestration alone) or an intervention arm (small fenestration with clipping', 'metal clips', 'FENestration with and without clipping']","['intraoperative and postoperative outcomes, including blood loss, operation time, severity grade of lymphocele/lymphorrhea and relative symptoms', 'incidence of symptomatic post-KTx lymphatic complications']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0015825', 'cui_str': 'Inner ear fenestration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0175722', 'cui_str': 'Clip'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0024248', 'cui_str': 'Lymphocele'}, {'cui': 'C0333258', 'cui_str': 'Extravasation of lymph'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.211961,"INTRODUCTION


Peritoneal fenestration is an effective preventive method for reducing the rate of lymphatic complications in kidney transplantation (KTx).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Golriz', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Mohammadsadegh', 'Initials': 'M', 'LastName': 'Sabagh', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mohammadi', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Ghamarnejad', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Khajeh', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Mieth', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Al-Saeedi', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'André L', 'Initials': 'AL', 'LastName': 'Mihaljevic', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Morath', 'Affiliation': 'Department of Nephrology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Zeier', 'Affiliation': 'Department of Nephrology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Yakup', 'Initials': 'Y', 'LastName': 'Kulu', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Arianeb', 'Initials': 'A', 'LastName': 'Mehrabi', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany arianeb.mehrabi@med.uni-heidelberg.de.'}]",BMJ open,['10.1136/bmjopen-2019-032286']
2551,33051228,"Effect of clindamycin and a live biotherapeutic on the reproductive outcomes of IVF patients with abnormal vaginal microbiota: protocol for a double-blind, placebo-controlled multicentre trial.","INTRODUCTION


Recent studies in in vitro fertilisation (IVF) patients have associated abnormal vaginal microbiota (AVM) with poor clinical pregnancy rates of 6%-9% per embryo transfer. The biological plausibility for this finding is hypothesised to be ascending infection to the endometrium which in turn hampers embryo implantation. New molecular based diagnosis may offer advantages compared to microscopical diagnosis of AVM which has huge inter-study variability ranging from 4 to 38%; however, the important question is whether screening and treatment of AVM would improve reproductive outcomes in IVF patients. Herein, we describe a protocol for an ongoing double-blind, placebo-controlled multicentre trial of IVF patients diagnosed with AVM and randomised in three parallel groups 1:1:1.
METHODS AND ANALYSIS


This is a drug intervention study where IVF patients will be screened for AVM, using a qPCR assay targeting  Atopobium vaginae  and  Gardnerella vaginalis . If positive, patients will be randomised to one of the three study arms. The first arm consists of clindamycin 300 mg ×2 daily for 7 days followed by vaginal  Lactobacillus crispatus  CTV-05 until clinical pregnancy scan week 7-9. The second arm consists of clindamycin and placebo  L. crispatus  CTV-05, whereas patients in the third arm will be treated with placebo/placebo. We used a superiority design to estimate that active treatment in both arms will increase the primary outcome, clinical pregnancy rate per embryo transfer, from 20% to 40%. A potential difference between the two active arms was considered exploratory. With a power of 80% and an alpha at 5%, the sample size is estimated to be 333 patients randomised. A pre-planned interim analysis is scheduled at 167 patients randomised.
ETHICS AND DISSEMINATION


All patients have to give informed consent. Dissemination of results is ensured in clinical trial agreements whether they be positive or not. Ethics committee, Central Denmark Region approved this protocol.
TRIAL REGISTRATION NUMBER


ICH-GCP monitored trial, EudraCT 2016-002385-31; Pre-results.",2020,"We used a superiority design to estimate that active treatment in both arms will increase the primary outcome, clinical pregnancy rate per embryo transfer, from 20% to 40%.","['167 patients randomised', 'IVF patients diagnosed with AVM and randomised in three parallel groups 1:1:1', 'IVF patients', '333 patients randomised', 'IVF patients with abnormal vaginal microbiota']","['placebo/placebo', 'clindamycin and a live biotherapeutic', 'placebo', 'clindamycin and placebo', 'clindamycin']",['clinical pregnancy rate per embryo transfer'],"[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517724', 'cui_str': '333'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008947', 'cui_str': 'Clindamycin'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]",,0.748669,"We used a superiority design to estimate that active treatment in both arms will increase the primary outcome, clinical pregnancy rate per embryo transfer, from 20% to 40%.","[{'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Haahr', 'Affiliation': 'Department of Clinical Medicine, Aarhus Universitet, Aarhus, Denmark thohaa@rm.dk.'}, {'ForeName': 'Nina La Cour', 'Initials': 'NC', 'LastName': 'Freiesleben', 'Affiliation': 'The Fertility Clinic, Hvidovre University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Henriette Svarre', 'Initials': 'HS', 'LastName': 'Nielsen', 'Affiliation': 'The Fertility Clinic, Hvidovre University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Hartvig', 'Affiliation': 'Stork Fertility Clinic, Copenhagen, Denmark.'}, {'ForeName': 'Anne-Lis', 'Initials': 'AL', 'LastName': 'Mikkelsen', 'Affiliation': 'The Fertility Clinic, Sjællands Universitetshospital Køge, Koge, Sjaelland, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Parks', 'Affiliation': 'Osel Inc, Mountain View, California, USA.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Uldbjerg', 'Affiliation': 'Department of Clinical Medicine, Aarhus Universitet, Aarhus, Denmark.'}, {'ForeName': 'Jørgen Skov', 'Initials': 'JS', 'LastName': 'Jensen', 'Affiliation': 'Department of Reproductive Microbiology, Statens Serum Institute, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Humaidan', 'Affiliation': 'Department of Clinical Medicine, Aarhus Universitet, Aarhus, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-035866']
2552,33051239,Abemaciclib Reigns Over Breast Cancer in MonarchE.,"Adding abemaciclib to adjuvant endocrine therapy may lead to better outcomes in hormone receptor-positive, HER2-negative, high-risk, early breast cancer. In a phase III trial, the combination improved invasive disease-free survival and distant relapse-free survival compared with endocrine therapy alone. However, a trial of another CDK4/6 inhibitor came to the opposite conclusion.",2020,"In a phase III trial, the combination improved invasive disease-free survival and distant relapse-free survival compared with endocrine therapy alone.",['Abemaciclib Reigns Over Breast Cancer in MonarchE'],[],['invasive disease-free survival and distant relapse-free survival'],"[{'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]",[],"[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.037244,"In a phase III trial, the combination improved invasive disease-free survival and distant relapse-free survival compared with endocrine therapy alone.",[],Cancer discovery,['10.1158/2159-8290.CD-NB2020-093']
2553,33051254,The Nature of Recruitment and Derecruitment and its Implications for Management of ARDS.,"Recruitment maneuvers (RM) in ARDS are used to improve oxygenation and lung mechanics by apply high airway pressures to re-open collapsed or obstructed peripheral airways and alveoli. In the early 1990's RMs became a central feature of a variant form of lung protective ventilation (LPV) known as ""open-lung ventilation"" (OLV).This strategy is based upon the belief that repetitive opening and closing of distal airspaces induces shear injury, and therefore contributes both to ventilator-induced lung injury and ARDS-associated mortality.However, the largest, multi-center randomized controlled trial of OLV in moderate to severe ARDS, wherein RM plateau pressures of 50-60 cmH 2 O were used, was associated with significantly higher mortality compared to traditional LPV. Despite being based upon well conducted pre-clinical and clinical RM studies, the higher mortality associated with the OLV strategy requires re-examining the assumptions and conclusions drawn from those previous studies.This narrative review examines the evidence used to design RM strategies. We also review the radiologic, rheologic, and histopathologic evidence regarding the nature of lung injury, the phenomena of recruitment and derecruitment as it informs our perceptions of recruitment potential in ARDS. Major LPV clinical trial data and other clinical data are also examined to assess the practical necessity of RM in ARDS, and whether a subset of cases might benefit from pursuing RM therapy. Finally, a less a radical approach to RM is offered that might achieve the goals of RM with less risk of harm.",2020,"Finally, a less a radical approach to RM is offered that might achieve the goals of RM with less risk of harm.",[],['OLV'],"['mortality', 'RM plateau pressures']",[],"[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0445176', 'cui_str': 'Plateau pressure'}]",,0.0501,"Finally, a less a radical approach to RM is offered that might achieve the goals of RM with less risk of harm.","[{'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Kallet', 'Affiliation': 'Respiratory Care Division, Department of Anesthesia and Perioperative Care, University of California San Francisco at San Francisco General Hospital.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lipnick', 'Affiliation': 'Critical Care Division, Department of Anesthesia and Perioperative Care, University of California San Francisco at San Francisco General Hospital.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Burns', 'Affiliation': 'Respiratory Care Division, Department of Anesthesia and Perioperative Care, University of California San Francisco at San Francisco General Hospital.'}]",Respiratory care,['10.4187/respcare.08280']
2554,31730601,Clinical Trials: Understanding Patient Perspectives and Beliefs About Treatment.,"BACKGROUND


Understanding the experiences of patients with solid tumors who are in phase 1 clinical trials can help nurses to provide optimal care.
OBJECTIVES


The purpose of this article is to describe patient perspectives of participating in a phase 1 trial and understanding their disease status and treatment options. In addition, the authors describe the impact of the disease and clinical trial participation on quality of life.
METHODS


30 patients were interviewed and audio recorded; the interviews were transcribed and content analysis methods were used to identify common themes.
FINDINGS


Patients reported participating in the phase 1 clinical trial because their doctors informed and encouraged them, they had no other treatment options if they wanted to live longer, or they wanted to help future patients with cancer. Most believed that participation would improve or stabilize their illness and quality of life. They believed that, when the clinical trial ended, there would be new treatments. Participants reported that healthcare providers and family members provided support, and that compassion, cultural awareness, spiritual support, and the need for individual attention were important.",2019,"FINDINGS


Patients reported participating in the phase 1 clinical trial because their doctors informed and encouraged them, they had no other treatment options if they wanted to live longer, or they wanted to help future patients with cancer.","['30 patients', 'patients with solid tumors']",[],['quality of life'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",30.0,0.0498099,"FINDINGS


Patients reported participating in the phase 1 clinical trial because their doctors informed and encouraged them, they had no other treatment options if they wanted to live longer, or they wanted to help future patients with cancer.","[{'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Ferrell', 'Affiliation': 'City of Hope National Medical Center.'}, {'ForeName': 'Anna Cathy', 'Initials': 'AC', 'LastName': 'Williams', 'Affiliation': 'City of Hope National Medical Center.'}, {'ForeName': 'Tami', 'Initials': 'T', 'LastName': 'Borneman', 'Affiliation': 'City of Hope National Medical Center.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Chung', 'Affiliation': 'City of Hope National Medical Center.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': 'Johns Hopkins Sidney Kimmel Comprehensive Cancer Center.'}]",Clinical journal of oncology nursing,['10.1188/19.CJON.592-598']
2555,31810575,"One-Time Intravitreal Injection of KVD001, a Plasma Kallikrein Inhibitor, in Patients with Central-Involved Diabetic Macular Edema and Reduced Vision: An Open-Label Phase 1B Study.",,2019,,['Patients with Central-Involved Diabetic Macular Edema and Reduced Vision'],"['KVD001, a Plasma Kallikrein Inhibitor']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}]","[{'cui': 'C2919497', 'cui_str': 'Kallikrein inhibitor'}]",[],,0.0107541,,"[{'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Beetham Eye Institute, Joslin Diabetes Center, Boston, Massachusetts; Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts. Electronic address: jennifer.sun@joslin.harvard.edu.'}, {'ForeName': 'Raj K', 'Initials': 'RK', 'LastName': 'Maturi', 'Affiliation': 'Midwest Eye Institute, Indianapolis, Indiana.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Boyer', 'Affiliation': 'Retina Vitreous Associates Medical Group, Beverly Hills, California.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Wells', 'Affiliation': 'Palmetto Retina Center, West Columbia, South Carolina.'}, {'ForeName': 'Victor H', 'Initials': 'VH', 'LastName': 'Gonzalez', 'Affiliation': 'Valley Retina Institute, McAllen, Texas.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Tansley', 'Affiliation': 'Kalvista Pharmaceuticals, Porton Down, United Kingdom, and Cambridge, Massachusetts.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hernandez', 'Affiliation': 'Kalvista Pharmaceuticals, Porton Down, United Kingdom, and Cambridge, Massachusetts.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Maetzel', 'Affiliation': 'Kalvista Pharmaceuticals, Porton Down, United Kingdom, and Cambridge, Massachusetts; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Edward P', 'Initials': 'EP', 'LastName': 'Feener', 'Affiliation': 'Kalvista Pharmaceuticals, Porton Down, United Kingdom, and Cambridge, Massachusetts.'}, {'ForeName': 'Lloyd Paul', 'Initials': 'LP', 'LastName': 'Aiello', 'Affiliation': 'Beetham Eye Institute, Joslin Diabetes Center, Boston, Massachusetts; Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts.'}]",Ophthalmology. Retina,['10.1016/j.oret.2019.07.006']
2556,32126989,"Impact of seasonal malaria chemoprevention on hospital admissions and mortality in children under 5 years of age in Ouelessebougou, Mali.","BACKGROUND


Seasonal malaria chemoprevention is widely implemented in Sahel and sub-Sahel countries in Africa. Few studies have assessed the impact of the SMC on hospital admission and death when it is implemented in the health system. This retrospective study assessed the impact of seasonal malaria chemoprevention (SMC) on hospitalizations and deaths of children under 5 years of age during the second year of implementation of SMC in the health district of Ouelessebougou in Mali.
METHODS


In February 2017, a survey was conducted to assess hospital admissions and deaths in children under 5 years of age in two health sub-districts where SMC was implemented in 2015 and two health sub-districts where SMC was not implemented. The survey reviewed deaths and hospitalizations of children under 5, in the four health sub-districts. The crude and specific incidence rates of hospitalizations and deaths were determined in both groups and expressed per 1000 children per year. A negative binomial regression model and a Cox model were used to estimate the relative risks of hospitalization and death after adjusting for confounders. The R software was used for data analysis.
RESULTS


A total of 6638 children under 5 years of age were surveyed, 2759 children in the SMC intervention areas and 3879 children in the control areas. All causes mortality rate per 1000 person-years was 8.29 in the control areas compared to 3.63 in the intervention areas; age and gender adjusted mortality rate ratio 0.44 (95% CI 0.22-0.91), p = 0.027. The incidence rate of all causes hospital admissions was 19.60 per 1000 person-years in the intervention group compared to 33.45 per 1000 person-years in the control group, giving an incidence rate ratio (IRR) adjusted for age and gender of 0.61 (95% CI 0.44-0.84), p = 0.003.
CONCLUSION


The implementation of SMC was associated with a substantial reduction in hospital admissions and all-cause mortality. Trial registration ClinicalTrials.gov NCT02646410.",2020,"All causes mortality rate per 1000 person-years was 8.29 in the control areas compared to 3.63 in the intervention areas; age and gender adjusted mortality rate ratio 0.44 (95% CI 0.22-0.91), p = 0.027.","['children under 5\xa0years of age in two health sub-districts where SMC was implemented in 2015 and two health sub-districts where SMC was not implemented', 'Sahel and sub-Sahel countries in Africa', '6638 children under 5\xa0years of age were surveyed, 2759 children in the SMC intervention areas and 3879 children in the control areas', 'children under 5\xa0years of age during the second year of implementation of SMC in the health district of Ouelessebougou in Mali', 'children under 5, in the four health sub-districts', 'children under 5\xa0years of age in Ouelessebougou, Mali']","['seasonal malaria chemoprevention (SMC', 'seasonal malaria chemoprevention']","['mortality rate', 'hospital admissions and deaths', 'crude and specific incidence rates of hospitalizations and deaths', 'hospitalizations and deaths', 'hospital admissions and mortality', 'incidence rate ratio (IRR', 'incidence rate of all causes hospital admissions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0024581', 'cui_str': 'Mali'}]","[{'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]",6638.0,0.0649575,"All causes mortality rate per 1000 person-years was 8.29 in the control areas compared to 3.63 in the intervention areas; age and gender adjusted mortality rate ratio 0.44 (95% CI 0.22-0.91), p = 0.027.","[{'ForeName': 'Djibrilla', 'Initials': 'D', 'LastName': 'Issiaka', 'Affiliation': 'Malaria Research & Training Center, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science Techniques and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Barry', 'Affiliation': 'Malaria Research & Training Center, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science Techniques and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Tiangoua', 'Initials': 'T', 'LastName': 'Traore', 'Affiliation': 'Malaria Research & Training Center, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science Techniques and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Diarra', 'Affiliation': 'Centre de Santé de Reference de Ouelessebougou, Ouelessebougou, Mali.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cook', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Keita', 'Affiliation': 'Programme National de Lutte contre le Paludisme, Bamako, Mali.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Sagara', 'Affiliation': 'Malaria Research & Training Center, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science Techniques and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Duffy', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Fried', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Alassane', 'Initials': 'A', 'LastName': 'Dicko', 'Affiliation': 'Malaria Research & Training Center, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science Techniques and Technologies of Bamako, Bamako, Mali. adicko@icermali.org.'}]",Malaria journal,['10.1186/s12936-020-03175-y']
2557,33053823,"Vitamin D Supplementation Does Not Impact Resting Metabolic Rate, Body Composition and Strength in Vitamin D Sufficient Physically Active Adults.","Supplementation with the most efficient form of Vitamin D (VitD3) results in improvements in energy metabolism, muscle mass and strength in VitD deficient individuals. Whether similar outcomes occur in VitD sufficient individuals' remains to be elucidated. The aim of this study is to determine the effect of VitD3 supplementation on resting metabolic rate (RMR), body composition and strength in VitD sufficient physically active young adults. Participants completed pre-supplementation testing before being matched for sunlight exposure and randomly allocated in a counterbalanced manner to the VitD3 or placebo group. Following 12 weeks of 50 IU/kg body-mass VitD3 supplementation, participants repeated the pre-supplementation testing. Thirty-one adults completed the study (19 females and 12 males; mean ± standard deviation (SD); age = 26.6 ± 4.9 years; BMI = 24.2 ± 4.1 kg·m 2 ). The VitD group increased serum total 25(OH)D by 30 nmol/L while the placebo group decreased total serum concentration by 21 nmol/L, reaching 123 (51) and 53 (42.2) nmol/L, respectively. There were no significant changes in muscle strength or power, resting metabolic rate and body composition over the 12-week period. Physically active young adults that are VitD sufficient have demonstrated that no additional physiological effects of achieving supraphysiological serum total 25(OH)D concentrations after VitD3 supplementation.",2020,"There were no significant changes in muscle strength or power, resting metabolic rate and body composition over the 12-week period.","['Physically active young adults', 'VitD sufficient physically active young adults', 'Thirty-one adults completed the study (19 females and 12 males; mean ± standard deviation (SD); age = 26.6 ± 4.9 years; BMI = 24.2 ± 4.1 kg·m 2 ', 'VitD deficient individuals']","['Vitamin D Supplementation', 'placebo', 'VitD3 or placebo', 'VitD3 supplementation', 'Vitamin D (VitD3']","['muscle strength or power, resting metabolic rate and body composition', 'resting metabolic rate (RMR), body composition and strength', 'total serum concentration', 'serum total 25(OH)D', 'energy metabolism, muscle mass and strength']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0919758', 'cui_str': 'Vitamin D measurement'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0523979', 'cui_str': 'Vitamin D3 measurement'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}]",31.0,0.13748,"There were no significant changes in muscle strength or power, resting metabolic rate and body composition over the 12-week period.","[{'ForeName': 'Karina Romeu', 'Initials': 'KR', 'LastName': 'Montenegro', 'Affiliation': 'School of Pharmacy and Biomedical Sciences, Curtin Health Innovation Research Institute, Curtin University, Perth, WA 6102, Australia.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Cruzat', 'Affiliation': 'Faculty of Health, Torrens University Australia, Melbourne, VIC 3000, Australia.'}, {'ForeName': 'Hilton', 'Initials': 'H', 'LastName': 'Melder', 'Affiliation': 'Faculty of Health, Torrens University Australia, Melbourne, VIC 3000, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jacques', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, WA 6102, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Newsholme', 'Affiliation': 'School of Pharmacy and Biomedical Sciences, Curtin Health Innovation Research Institute, Curtin University, Perth, WA 6102, Australia.'}, {'ForeName': 'Kagan J', 'Initials': 'KJ', 'LastName': 'Ducker', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, WA 6102, Australia.'}]",Nutrients,['10.3390/nu12103111']
2558,33053843,Effect of Omega-3 Long Chain Polyunsaturated Fatty Acids (n-3 LCPUFA) Supplementation on Cognition in Children and Adolescents: A Systematic Literature Review with a Focus on n-3 LCPUFA Blood Values and Dose of DHA and EPA.,"Omega-3 long chain polyunsaturated fatty acids (n-3 LCPUFA) supplementation in the cardiovascular field is effective if a certain Omega-3 index (O3I) is achieved or the daily n-3 LCPUFA dose is high enough. Whether this applies to studies on cognition in children and adolescents is unclear. The aims of the current review were to investigate whether: (1) a certain O3I level and (2) a minimum daily n-3 LCPUFA dose are required to improve cognition in 4-25 year olds. Web of Science and PubMed were searched. Inclusion criteria: placebo controlled randomized controlled trial; participants 4-25 years; supplementation with docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA); assessing cognition; in English and ≥10 participants per treatment arm. Thirty-three studies were included, 21 in typically developing participants, 12 in those with a disorder. A positive effect on cognitive measures was more likely in studies with an increase in O3I to >6%. Half of the studies in typically developing children with daily supplementation dose ≥450 mg DHA + EPA showed improved cognition. For children with a disorder no cut-off value was found. In conclusion, daily supplementation of ≥450 mg DHA + EPA per day and an increase in the O3I to >6% makes it more likely to show efficacy on cognition in children and adolescents.",2020,"In conclusion, daily supplementation of ≥450 mg DHA + EPA per day and an increase in the O3I to >6% makes it more likely to show efficacy on cognition in children and adolescents.","['Thirty-three studies were included, 21 in typically developing participants, 12 in those with a disorder', 'English and ≥10 participants per treatment arm', 'Children and Adolescents', 'children and adolescents']","['DHA + EPA', 'Omega-3 Long Chain Polyunsaturated Fatty Acids (n-3 LCPUFA) Supplementation', 'Omega-3 long chain polyunsaturated fatty acids (n-3 LCPUFA) supplementation', 'placebo', 'docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA']","['cognitive measures', 'cognition']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.151666,"In conclusion, daily supplementation of ≥450 mg DHA + EPA per day and an increase in the O3I to >6% makes it more likely to show efficacy on cognition in children and adolescents.","[{'ForeName': 'Inge S M', 'Initials': 'ISM', 'LastName': 'van der Wurff', 'Affiliation': 'Conditions for Lifelong Learning, Faculty of Educational Sciences, Open University of the Netherlands, 6419 Heerlen, The Netherlands.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Meyer', 'Affiliation': 'School of Medicine, Lipid Research Centre, Molecular Horizons, Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, NSW 2522, Australia.'}, {'ForeName': 'Renate H M', 'Initials': 'RHM', 'LastName': 'de Groot', 'Affiliation': 'Conditions for Lifelong Learning, Faculty of Educational Sciences, Open University of the Netherlands, 6419 Heerlen, The Netherlands.'}]",Nutrients,['10.3390/nu12103115']
2559,33054008,[The effectiveness of combined laser therapy in patients with trophic leg ulcer and chronic venous insufficiency].,"New prospects associated with the use of laser radiation of different wavelengths in the ultraviolet (365 nm) and the green emission spectrum (525 nm) have appeared in recent years. The high prevalence of the trophic leg ulcers necessitates the search for more effective methods of conservative treatment.
PURPOSE OF THE STUDY


Development and scientific justification for the low-intensity laser radiation of different wavelengths combined use in patients with trophic leg ulcers and chronic venous insufficiency (CVI).
MATERIAL AND METHODS


102 patients with trophic leg ulcers and CVI were examined. They were divided into 3 equal groups using simple randomization. Patients in the control group received only traditional conservative therapy; comparison group - traditional conservative therapy and an intravenous laser blood irradiation (ILBI) (λ - 635 nm); the main group - traditional conservative therapy and different wavelengths laser therapy (LT) course.
RESULTS AND CONCLUSION


A more significant improvement in the clinical condition occurred under the influence of the course application of combined different wavelengths laser therapy in patients with trophic venous leg ulcers. Compared to patients who received traditional conservative therapy and in combination with ILBI 635 nm, the speed of reparative regeneration of trophic ulcers increased, the time for cleansing trophic ulcers from devitalized tissues was reduced. Computer capillaroscopy data showed that the positive effect of laser exposure on all parts of the microcirculation underlies its therapeutic efficacy.",2020,"Patients in the control group received only traditional conservative therapy; comparison group - traditional conservative therapy and an intravenous laser blood irradiation (ILBI) (λ - 635 nm); the main group - traditional conservative therapy and different wavelengths laser therapy (LT) course.
","['102 patients with trophic leg ulcers and CVI were examined', 'patients with trophic leg ulcer and chronic venous insufficiency', 'patients with trophic venous leg ulcers', 'patients with trophic leg ulcers and chronic venous insufficiency (CVI']","['combined laser therapy', 'traditional conservative therapy', 'traditional conservative therapy; comparison group - traditional conservative therapy and an intravenous laser blood irradiation (ILBI) (λ - 635 nm); the main group - traditional conservative therapy and different wavelengths laser therapy (LT) course']",['clinical condition'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023223', 'cui_str': 'Ulcer of lower extremity'}, {'cui': 'C1306557', 'cui_str': 'Venous insufficiency (chronic) (peripheral)'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",102.0,0.0101295,"Patients in the control group received only traditional conservative therapy; comparison group - traditional conservative therapy and an intravenous laser blood irradiation (ILBI) (λ - 635 nm); the main group - traditional conservative therapy and different wavelengths laser therapy (LT) course.
","[{'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Konchugova', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology, Moscow, Russia.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Askhadulin', 'Affiliation': 'Tula City Clinical Hospital No. 2 named after E.G. Lazarev, Tula, Russia.'}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'Kulchitskaya', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology, Moscow, Russia.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Fesyun', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology, Moscow, Russia.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Melnikova', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology, Moscow, Russia.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Nikitin', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology, Moscow, Russia.'}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",['10.17116/kurort20209705145']
2560,33054013,[The role of rehabilitation and apparatus physiotherapy in rheumatic disease treatment strategies].,"Rheumatic diseases are a serious medical and social problem. The variability of mechanisms for the development of this group of diseases requires different approaches: strategies of drug and non-medicament therapy in modern rheumatology are designed to complement each other. EULAR recommendations pay insufficient attention to the use of non-medical methods of joint disease treatment. According to modern research, multi-disciplinary rehabilitation strategies, including, in addition to drug therapy, educational programmes, physical training of various intensities, as well as the use of apparatus rehabilitation methods, have proven to be the most effective. Hardware physiotherapy seems to be optimal for the treatment of rheumatic patients due to its higher accessibility and lower cost in comparison with classical balneo- and peloidotherapy. With the use of magnetotherapy there is also greater safety and fewer contraindications to the procedures. The method of using pulsed magnetic fields is the most justified in the treatment of joint diseases, since the sensitivity of biological tissues to them is the highest. The clinical effectiveness of pulsed magnetotherapy has been demonstrated in several randomized placebo-controlled multi-centre studies. Against the background of carried out magnetic field therapy in patients were statistically significant reduction of pain and stiffness, improvement of joint function, which indicates the expediency of including the physical factor in the strategy of treatment of rheumatic diseases in combination with drug therapy.",2020,Hardware physiotherapy seems to be optimal for the treatment of rheumatic patients due to its higher accessibility and lower cost in comparison with classical balneo- and peloidotherapy.,['rheumatic patients'],"['rehabilitation and apparatus physiotherapy', 'pulsed magnetotherapy', 'placebo', 'magnetotherapy']","['pain and stiffness, improvement of joint function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0542330', 'cui_str': 'Joint mobilization'}]",,0.0160779,Hardware physiotherapy seems to be optimal for the treatment of rheumatic patients due to its higher accessibility and lower cost in comparison with classical balneo- and peloidotherapy.,"[{'ForeName': 'D E', 'Initials': 'DE', 'LastName': 'Karateev', 'Affiliation': 'M.F. Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Luchikhina', 'Affiliation': 'M.F. Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia.'}, {'ForeName': 'I P', 'Initials': 'IP', 'LastName': 'Osnovina', 'Affiliation': 'Ivanovo State Medical Academy, Ivanovo, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Makevnina', 'Affiliation': 'M.F. Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia.'}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",['10.17116/kurort20209705192']
2561,33054084,Prognostic and predictive role of gene mutations in chronic lymphocytic leukemia: results from the pivotal phase III study COMPLEMENT1.,"Next generation sequencing studies in Chronic lymphocytic leukemia (CLL) have revealed novel genetic variants that have been associated with disease characteristics and outcome. The aim of this study was to evaluate the prognostic value of recurrent molecular abnormalities in patients with CLL. Therefore, we assessed their incidences and associations with other clinical and genetic markers in the prospective multicenter COMPLEMENT1 trial (treatment naive patients not eligible for intensive treatment randomized to chlorambucil (CHL) vs. ofatumumab-CHL (O-CHL)). Baseline samples were available from 383 patients (85.6%) representative of the total trial cohort. Mutations were analyzed by amplicon-based targeted next generation sequencing (tNGS). In 52.2% of patients we found at least one mutation and the incidence was highest in NOTCH1 (17.0%), followed by SF3B1 (14.1%), ATM (11.7%), TP53 (10.2%), POT1 (7.0%), RPS15 (4.4%), FBXW7 (3.4%), MYD88 (2.6%) and BIRC3 (2.3%). While most mutations lacked prognostic significance, TP53 (HR2.02,p<0.01), SF3B1 (HR1.66,p=0.01) and NOTCH1 (HR1.39,p=0.03) were associated with inferior PFS in univariate analysis. Multivariate analysis confirmed the independent prognostic role of TP53 for PFS (HR1.71,p=0.04) and OS (HR2.78,p=0.02) and of SF3B1 for PFS only (HR1.52,p=0.02). Notably, NOTCH1 mutation status separates patients with a strong and a weak benefit from ofatumumab addition to CHL (NOTCH1wt:HR0.50,p<0.01, NOTCH1mut:HR0.81,p=0.45). In summary, TP53 and SF3B1 were confirmed as independent prognostic and NOTCH1 as a predictive factor for reduced ofatumumab efficacy in a randomized chemo (immune)therapy CLL trial. These results validate NGS-based mutation analysis in a multicenter trial and provide a basis for expanding molecular testing in the prognostic workup of patients with CLL. ClinicalTrials.gov registration number: NCT00748189.",2020,"Multivariate analysis confirmed the independent prognostic role of TP53 for PFS (HR1.71,p=0.04) and OS (HR2.78,p=0.02) and of SF3B1 for PFS only (HR1.52,p=0.02).","['patients with CLL', '383 patients (85.6%) representative of the total trial cohort', 'chronic lymphocytic leukemia', 'naive patients not eligible for intensive treatment randomized to', 'Chronic lymphocytic leukemia (CLL']",['chlorambucil (CHL) vs. ofatumumab-CHL (O-CHL'],"['FBXW7', 'TP53', 'RPS15', 'POT1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C1832027', 'cui_str': 'ofatumumab'}, {'cui': 'C0008107', 'cui_str': 'Chile'}]","[{'cui': 'C0755295', 'cui_str': 'FBXW7 protein, human'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}]",,0.156623,"Multivariate analysis confirmed the independent prognostic role of TP53 for PFS (HR1.71,p=0.04) and OS (HR2.78,p=0.02) and of SF3B1 for PFS only (HR1.52,p=0.02).","[{'ForeName': '', 'Initials': '', 'LastName': 'Eugen Tausch', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Philipp Beck', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Richard F Schlenk', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Billy J Jebaraj', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Anna Dolnik', 'Affiliation': 'Klinik fur Innere Medizin fur Hematologie, Onkologie und Tumorimmunologie, Charité Berlin.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Deyan Y Yosifov', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Peter Hillmen', 'Affiliation': ""Department of Haematology, St. James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': '', 'Initials': '', 'LastName': 'Fritz Offner', 'Affiliation': 'Universitair Ziekenhuis Gent, Gent, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Ann Janssens', 'Affiliation': 'Universitair Ziekenhuis Leuven, Leuven, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': 'K Govind Babu', 'Affiliation': 'Kidwai Memorial Institute of Oncology, Bangalore, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Sebastian Grosicki', 'Affiliation': 'Hematology and Cancer Prevention,School of Public Health,Silesian Medical University,Katowice,Poland.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Jiri Mayer', 'Affiliation': 'Department of Haematology-Oncology, University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Panagiotis Panagiotidis', 'Affiliation': 'University of Athens, Laikon General Hospital, Athens, Greece.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Astrid McKeown', 'Affiliation': 'Oncology Global Medicines Development, AstraZeneca, Melbourn, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Ira V Gupta', 'Affiliation': 'GSK Oncology, GlaxoSmithKline, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Alexandra Skorupa', 'Affiliation': 'Novartis Pharma GmbH, Nürnberg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Celine Pallaud', 'Affiliation': 'Novartis AG, Basel, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Lars Bullinger', 'Affiliation': 'Klinik fur Innere Medizin fur Hematologie, Onkologie und Tumorimmunologie, Charité, Berlin.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Daniel Mertens', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Hartmut Döhner', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Stephan Stilgenbauer', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}]",Haematologica,['10.3324/haematol.2019.229161']
2562,33054096,Impact of idelalisib on health-related quality of life in patients with relapsed chronic lymphocytic leukemia in a phase III randomized trial.,,2020,,['patients with relapsed chronic lymphocytic leukemia'],['idelalisib'],['health-related quality of life'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}]","[{'cui': 'C2698692', 'cui_str': 'idelalisib'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0429388,,"[{'ForeName': '', 'Initials': '', 'LastName': 'Paolo Ghia', 'Affiliation': 'Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milano, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Steven E Coutre', 'Affiliation': 'Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Bruce D Cheson', 'Affiliation': 'Georgetown University Hospital, Washington D.C., USA.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Jacqueline C Barrientos', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Peter Hillmen', 'Affiliation': ""St. James's University Hospital, Leeds, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': 'Andrew R Pettitt', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Andrew D Zelenetz', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Sanatan Shreay', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Michael Hallek', 'Affiliation': 'Dept. I of Internal Medicine, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Richard R Furman', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}]",Haematologica,['10.3324/haematol.2019.238808']
2563,33051975,Tripeptide and hexapeptide topical as adjunct to non-ablative fractional resurfacing for photodamage: A randomized split-face trial.,"BACKGROUND


Topical adjuncts have been investigated to improve clinical outcomes associated with laser resurfacing for photodamage and cutaneous aging. One such product is a tripeptide/hexapeptide serum, which has been shown to increase dermal collagen and elastin as well as improve post-procedural recovery following treatments.
OBJECTIVE


A randomized, blinded, split-face, comparative trial was performed to assess the utility of a tripeptide/hexapeptide serum as a peri-procedural adjunct to non-ablative fractional laser resurfacing.
MATERIALS AND METHODS


A total of 20 subjects were enrolled. Each hemiface was randomized to either tripeptide/hexapeptide serum or bland moisturizer for twice daily application starting 14 days prior to first laser treatment and continuing until 60 days after. All subjects received 2 treatments to entire face approximately 1 month apart with 1927nm thulium non-ablative fractional laser. Clinical measures and immediate post-procedural recovery were assessed.
RESULTS


For each hemiface, scores improved for all measures, including global photodamage, lentigines, pores, radiance, texture, and tone at 30 and 60 days. The tripeptide/hexapeptide serum had greater improvements for all measures at both time points, except for radiance at 60 days, which was equal. In cases where clinical ratings differed between sides, tripeptide/hexapeptide serum more frequently had the superior outcome. Overall, subjects were satisfied with tripeptide/hexapeptide serum. No significant adverse events were observed.
CONCLUSION


Addition of tripeptide/hexapeptide serum as a peri-procedural adjunct to non-ablative fractional laser resurfacing improved various clinical measures of photodamage and cutaneous aging and the immediate post-procedural recovery. The tripeptide/hexapeptide serum was demonstrated to be safe, well-tolerated, and well-liked by subjects.",2020,"The tripeptide/hexapeptide serum had greater improvements for all measures at both time points, except for radiance at 60 days, which was equal.","['A total of 20 subjects were enrolled', 'photodamage']","['laser resurfacing', 'Tripeptide and hexapeptide topical', 'tripeptide/hexapeptide serum or bland moisturizer', 'tripeptide/hexapeptide serum', '1927nm thulium non-ablative fractional laser']","['adverse events', 'global photodamage, lentigines, pores, radiance, texture, and tone']","[{'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040066', 'cui_str': 'Thulium'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0023321', 'cui_str': 'Lentigo'}, {'cui': 'C0449582', 'cui_str': 'With texture'}]",20.0,0.0276005,"The tripeptide/hexapeptide serum had greater improvements for all measures at both time points, except for radiance at 60 days, which was equal.","[{'ForeName': 'Jordan V', 'Initials': 'JV', 'LastName': 'Wang', 'Affiliation': 'Laser & Skin Surgery Center of New York, New York, NY, USA.'}, {'ForeName': 'Mitalee P', 'Initials': 'MP', 'LastName': 'Christman', 'Affiliation': 'Laser & Skin Surgery Center of New York, New York, NY, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': 'Laser & Skin Surgery Center of New York, New York, NY, USA.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Ferzli', 'Affiliation': 'Laser & Skin Surgery Center of New York, New York, NY, USA.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Jeon', 'Affiliation': 'Laser & Skin Surgery Center of New York, New York, NY, USA.'}, {'ForeName': 'Roy G', 'Initials': 'RG', 'LastName': 'Geronemus', 'Affiliation': 'Laser & Skin Surgery Center of New York, New York, NY, USA.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13795']
2564,33052030,Changes in DNA methylation after 6-week exercise training in colorectal cancer survivors: A preliminary study.,"AIM


Behavioral interventions such as exercise may induce epigenetic changes. Only few studies investigated the effects of exercise on epigenetic alterations in colorectal cancer survivors. The aim of this study was to explore the changes of genome-wide DNA methylation after 6-week exercise training in colorectal cancer survivors.
METHODS


This preliminary study used a subset of data from a randomized controlled trial in 15 colorectal cancer survivors. Participants were randomized either to the 6-week exercise group or control group. The exercise intervention consisted of a weekly, group-based, supervised resistance exercise program and a home-based same resistance exercise plus walking six times per week. Blood samples were collected at baseline and after the intervention and data from eight subjects were analyzed for genome-wide DNA methylation on 865,918 CpG sites.
RESULTS


Compared to the control group, the exercise group shows notable methylation changes in 756 CpG sites (22.7-25.2%). Gene ontology and disease annotation analysis showed that the genes targeting 81 CpG sites in promoter region with significant group-difference were linked in biological process such as immune response and transcription and related to metabolic and immune diseases. Also, hypermethylation on genes related to disease prevention seemed to be inhibited in the exercise group compared to the control group, indicating a likelihood of transcriptional activity of these genes.
CONCLUSION


We found a preliminary evidence of the positive effects of exercise intervention on epigenetic markers in colorectal cancer survivors. Larger scale randomized controlled trials are warranted to further investigate our findings.",2020,"Also, hypermethylation on genes related to disease prevention seemed to be inhibited in the exercise group compared to the control group, indicating a likelihood of transcriptional activity of these genes.
","['15 colorectal cancer survivors', 'colorectal cancer survivors']","['exercise group or control group', 'exercise training', 'exercise intervention', 'supervised resistance exercise program and a home-based same resistance exercise plus walking six times per week', 'exercise']","['notable methylation changes', 'epigenetic markers', 'Blood samples']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",15.0,0.0345452,"Also, hypermethylation on genes related to disease prevention seemed to be inhibited in the exercise group compared to the control group, indicating a likelihood of transcriptional activity of these genes.
","[{'ForeName': 'Seo-Hyeon', 'Initials': 'SH', 'LastName': 'Hwang', 'Affiliation': 'Exercise Medicine Center for Diabetes and Cancer Patients, Institute of Convergence of Science (ICONS), Yonsei University, Seoul, South Korea.'}, {'ForeName': 'Dong-Woo', 'Initials': 'DW', 'LastName': 'Kang', 'Affiliation': 'Behavioural Medicine Laboratory, Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Mi-Kyung', 'Initials': 'MK', 'LastName': 'Lee', 'Affiliation': 'Exercise Medicine Center for Diabetes and Cancer Patients, Institute of Convergence of Science (ICONS), Yonsei University, Seoul, South Korea.'}, {'ForeName': 'Ji Yong', 'Initials': 'JY', 'LastName': 'Byeon', 'Affiliation': 'Department of Sport Industry Studies, Yonsei University, Seoul, South Korea.'}, {'ForeName': 'Hanui', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Sport Industry Studies, Yonsei University, Seoul, South Korea.'}, {'ForeName': 'Dong-Hyuk', 'Initials': 'DH', 'LastName': 'Park', 'Affiliation': 'Department of Sport Industry Studies, Yonsei University, Seoul, South Korea.'}, {'ForeName': 'Kyung-Chul', 'Initials': 'KC', 'LastName': 'Kim', 'Affiliation': 'Department of healthy aging, Gangnam Major Clinic, Seoul, South Korea.'}, {'ForeName': 'Seung-Tae', 'Initials': 'ST', 'LastName': 'Lee', 'Affiliation': 'Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sang Hui', 'Initials': 'SH', 'LastName': 'Chu', 'Affiliation': 'Department of Clinical Nursing Science, College of Nursing, Biobehavioural Research Center, Yonsei University, Nursing Policy Research Institute, Seoul, South Korea.'}, {'ForeName': 'Nam Kyu', 'Initials': 'NK', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Justin Y', 'Initials': 'JY', 'LastName': 'Jeon', 'Affiliation': 'Exercise Medicine Center for Diabetes and Cancer Patients, Institute of Convergence of Science (ICONS), Yonsei University, Seoul, South Korea.'}]",Asia-Pacific journal of clinical oncology,['10.1111/ajco.13482']
2565,33052038,Shortening surgical training through robotics: randomized clinical trial of laparoscopic versus robotic surgical learning curves.,"BACKGROUND


Minimally invasive surgery is the standard technique for many operations. Laparoscopic training has a long learning curve. Robotic solutions may shorten the training pathway. The aim of this study was to compare laparoscopic with robotic training in surgical trainees and medical students.
METHODS


Surgical trainees (ST group) were randomized to receive 6 h of robotic or laparoscopic simulation training. They then performed three surgical tasks in cadaveric specimens. Medical students (MS group) had 2 h of robotic or laparoscopic simulation training followed by one surgical task. The Global Rating Scale (GRS) score (maximum 30), number of suture errors, and time to complete each procedure were recorded.
RESULTS


The median GRS score for the ST group was better for each procedure after robotic training compared with laparoscopic training (total GRS score: 27·00 (i.q.r. 22·25-28·33) versus 18·00 (16·50-19·04) respectively, P < 0·001; 10 participants in each arm). The ST group made fewer errors in robotic than in laparoscopic tasks, for both continuous (7·00 (4·75-9·63) versus 22·25 (20·75-25·25); P < 0·001) and interrupted (8·25 (6·38-10·13) versus 29·50 (23·75-31·50); P < 0·001) sutures. For the MS group, the robotic group completed 8·67 interrupted sutures with 15·50 errors in 40 min, compared with only 3·50 sutures with 40·00 errors in the laparoscopic group (P < 0·001) (10 participants in each arm). Fatigue and physical comfort levels were better after robotic compared with laparoscopic operating for both groups (P < 0·001).
CONCLUSION


The acquisition of surgical skills in surgical trainees and the surgically naive takes less time with a robotic compared with a laparoscopic platform.",2020,"Fatigue and physical comfort levels were better after robotic compared with laparoscopic operating for both groups (P < 0·001).
","['Surgical trainees (ST group', 'Medical students (MS group) had 2\u2009h of robotic or laparoscopic simulation training followed by one surgical task', 'surgical trainees and medical students']","['Laparoscopic training', '6\u2009h of robotic or laparoscopic simulation training', 'Robotic solutions', 'laparoscopic training', 'laparoscopic versus robotic surgical learning curves', 'laparoscopic with robotic training']","['Fatigue and physical comfort levels', 'median GRS score', 'Global Rating Scale (GRS) score (maximum 30), number of suture errors, and time to complete each procedure']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0457280', 'cui_str': 'Number of sutures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",,0.121734,"Fatigue and physical comfort levels were better after robotic compared with laparoscopic operating for both groups (P < 0·001).
","[{'ForeName': 'T M H', 'Initials': 'TMH', 'LastName': 'Gall', 'Affiliation': 'The Academic Surgical Unit, The Royal Marsden Hospital, Imperial College, London, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Alrawashdeh', 'Affiliation': 'Hepatopancreatobiliary Surgical Unit, Newcastle upon Tyne, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Soomro', 'Affiliation': 'Department of Urology, The Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'White', 'Affiliation': 'Hepatopancreatobiliary Surgical Unit, Newcastle upon Tyne, UK.'}, {'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Jiao', 'Affiliation': 'The Academic Surgical Unit, The Royal Marsden Hospital, Imperial College, London, UK.'}]",BJS open,['10.1002/bjs5.50353']
2566,33052103,"Comparison of safety and efficacy between calcipotriol plus betamethasone dipropionate gel and calcipotriol scalp solution as long-term treatment for scalp psoriasis in Chinese patients: a national, multicentre, prospective, randomized, active-controlled Phase 4 trial.","BACKGROUND


The efficacy and safety of calcipotriol plus betamethasone dipropionate gel for the treatment of scalp psoriasis has previously been demonstrated in a four-week trial in a Chinese population.
OBJECTIVE


To evaluate the long-term safety and efficacy of two-compound gel in Chinese adult patients with scalp psoriasis.
MATERIALS AND METHODS


A multicentre, prospective, randomized, active-controlled trial was established in which subjects were randomized (at a ratio of 4:1) to receive either two-compound gel once daily or calcipotriol scalp solution twice daily for 28 weeks. Incidence of adverse drug reactions (ADRs) of any type and adverse events (AEs) of concern associated with long-term corticosteroid use on the scalp were evaluated.
RESULTS


A total of 951 subjects were randomly assigned to receive either two-compound gel (n=760) or calcipotriol scalp solution (n=191). The incidence of ADRs was significantly lower in the two-compound gel group compared with the calcipotriol scalp solution group (11.7 vs. 22.2%, p<0.001). There was no significant difference in treatment-emergent adverse events (TEAEs) associated with long-term topical corticosteroid use on the scalp (1.1% vs. 0%, p=0.369) between the two groups. A statistically significant difference in the percentage of visits with treatment success according to the Subject's Global Assessment was observed (p=0.009); more subjects had visits with 100% treatment success (15.2 vs. 6.3%) and fewer subjects had visits with 0% treatment success (23.7 vs. 30.8%) using two-compound gel compared to calcipotriol scalp solution.
CONCLUSIONS


The two-compound gel was well tolerated and effective in the long-term management of scalp psoriasis in Chinese patients.",2020,"There was no significant difference in treatment-emergent adverse events (TEAEs) associated with long-term topical corticosteroid use on the scalp (1.1% vs. 0%, p=0.369) between the two groups.","['A total of 951 subjects', 'Chinese adult patients with scalp psoriasis', 'Chinese patients', 'scalp psoriasis in Chinese patients']","['two-compound gel once daily or calcipotriol scalp solution', 'calcipotriol plus betamethasone dipropionate gel', 'two-compound gel', 'two-compound gel (n=760) or calcipotriol scalp solution', 'calcipotriol scalp solution', 'calcipotriol plus betamethasone dipropionate gel and calcipotriol scalp solution']","['Incidence of adverse drug reactions (ADRs) of any type and adverse events (AEs) of concern', 'safety and efficacy', 'incidence of ADRs', 'tolerated and effective', 'treatment-emergent adverse events (TEAEs']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0406326', 'cui_str': 'Scalp psoriasis'}]","[{'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",951.0,0.13496,"There was no significant difference in treatment-emergent adverse events (TEAEs) associated with long-term topical corticosteroid use on the scalp (1.1% vs. 0%, p=0.369) between the two groups.","[{'ForeName': 'Lunfei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Chunlei', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Jinyan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Ningbo No.2 Hospital, Ningbo, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, China.'}, {'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Shanghai Skin Disease Hospital, Shanghai, China.'}, {'ForeName': 'Guofu', 'Initials': 'G', 'LastName': 'Yan', 'Affiliation': 'Chongqing Traditional Chinese Medicine Hospital, Chongqing, China.'}, {'ForeName': 'Qianjin', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'West China Hospital Sichuan University, Chengdu, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Sir Run Run Shaw Hospital (SRRSH) Zhejiang University, School of Medicine, Hangzhou, China.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'The Third Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': ""Zhejiang Provincial People's Hospital, Hangzhou, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Fudan University Zhongshan Hospital, Shanghai, China.'}, {'ForeName': 'Shuanglin', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Xiuping', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Yayuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}]",European journal of dermatology : EJD,['10.1684/ejd.2020.3876']
2567,33052122,"Costing and Cost-Effectiveness of a Mobile Health Intervention (ImTeCHO) in Improving Infant Mortality in Tribal Areas of Gujarat, India: Cluster Randomized Controlled Trial.","BACKGROUND


During 2013, a mobile health (mHealth) program, Innovative Mobile Technology for Community Health Operation (ImTeCHO), was launched in predominantly tribal and rural communities of Gujarat, India. ImTeCHO was developed as a job aid for Accredited Social Health Activists (ASHAs) and staff of primary health centers to increase coverage of maternal, neonatal, and child health care.
OBJECTIVE


In this study, we assessed the incremental cost per life-years saved as a result of the ImTeCHO intervention as compared to routine maternal, neonatal, and child health care programs.
METHODS


A two-arm, parallel, stratified cluster randomized trial with 11 clusters (primary health centers) randomly allocated to the intervention (280 ASHAs, n=2,34,134) and control (281 ASHAs, n=2,42,809) arms was initiated in 2015 in a predominantly tribal and rural community of Gujarat. A system of surveillance assessed all live births and infant deaths in the intervention and control areas. All costs, including those required during the start-up and implementation phases, were estimated from a program perspective. Incremental cost-effectiveness ratios were estimated by dividing the incremental cost of the intervention with the number of deaths averted to estimate the cost per infant death averted. This was further analyzed to estimate the cost per life-years saved for the purpose of comparability. Sensitivity analysis was undertaken to account for parameter uncertainties.
RESULTS


Out of a total of 5754 live births (3014 in the intervention arm, 2740 in the control arm) reported in the study area, per protocol analysis showed that the implementation of ImTeCHO resulted in saving 11 infant deaths per 1000 live births in the study area at an annual incremental cost of US $163,841, which is equivalent to US $54,360 per 1000 live births. Overall, ImTeCHO is a cost-effective intervention from a program perspective at an incremental cost of US $74 per life-years saved or US $5057 per death averted. In a realistic environment with district scale-up, the program is expected to become even more cost-effective.
CONCLUSIONS


Overall, the findings of our study strongly suggest that the mHealth intervention as part of the ImTeCHO program is cost-effective and should be considered for replication elsewhere in India.
TRIAL REGISTRATION


Clinical Trials Registry of India CTRI/2015/06/005847; http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=11820&EncHid=&modid=&compid=%27,%2711820det%27.",2020,"Overall, ImTeCHO is a cost-effective intervention from a program perspective at an incremental cost of US $74 per life-years saved or US $5057 per death averted.","['5754 live births (3014 in the intervention arm, 2740 in the control arm', '11 clusters (primary health centers) randomly allocated to the intervention (280 ASHAs, n=2,34,134) and control (281 ASHAs, n=2,42,809) arms was initiated in 2015 in a predominantly tribal and rural community of Gujarat']",['Mobile Health Intervention'],"['live births and infant deaths', 'Incremental cost-effectiveness ratios']","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0021278', 'cui_str': 'Mortality, Infant'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0740625,"Overall, ImTeCHO is a cost-effective intervention from a program perspective at an incremental cost of US $74 per life-years saved or US $5057 per death averted.","[{'ForeName': 'Dhiren', 'Initials': 'D', 'LastName': 'Modi', 'Affiliation': 'Society for Education, Welfare and Action (SEWA) Rural, Bharuch, India.'}, {'ForeName': 'Somen', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Indian Institute of Public Health Gandhinagar, Gandhinagar, India.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Vaghela', 'Affiliation': 'Health & Family Welfare Department, Gujarat, Gandhinagar, India.'}, {'ForeName': 'Kapilkumar', 'Initials': 'K', 'LastName': 'Dave', 'Affiliation': 'Society for Education, Welfare and Action (SEWA) Rural, Bharuch, India.'}, {'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': ''}, {'ForeName': 'Shrey', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': 'Society for Education, Welfare and Action (SEWA) Rural, Bharuch, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Society for Education, Welfare and Action (SEWA) Rural, Bharuch, India.'}]",JMIR mHealth and uHealth,['10.2196/17066']
2568,33052125,The Impact of Visualization Format and Navigational Options on Laypeople's Perception and Preference of Surgery Information Videos: Randomized Controlled Trial and Online Survey.,"BACKGROUND


Patients need to be educated about possible treatment choices in order to make informed medical decisions. As most patients are medical laypeople, they find it difficult to understand complex medical information sufficiently to feel confident about a decision. Multimedia interventions such as videos are increasingly used to supplement personal consultations with medical professionals. Former research has shown that such interventions may have a positive effect on understanding, decision making, and emotional reactions. However, it is thus far unclear how different features of videos influence these outcomes.
OBJECTIVE


We aimed to examine the impact of visualization formats and basic navigational options in medical information videos about cruciate ligament surgery on recipients' knowledge gain, emotions, attitude, and hypothetical decision-making ability.
METHODS


In a between-group randomized experiment (Study 1), 151 participants watched 1 of 4 videos (schematic vs realistic visualization; available vs unavailable navigational options). In a separate online survey (Study 2), 110 participants indicated their preference for a video design. All participants were medical laypeople without personal experience with a cruciate ligament rupture and were presented with a fictional decision situation.
RESULTS


In Study 1, participants who used navigational options (n=36) gained significantly more factual knowledge (P=.005) and procedural knowledge (P<.001) than participants who did not have or use navigational options (n=115). A realistic visualization induced more fear (P=.001) and disgust (P<.001) than a schematic video. Attitude toward the surgery (P=.02) and certainty regarding the decision for or against surgery (P<.001) were significantly more positive after watching the video than before watching the video. Participants who watched a schematic video rated the video significantly higher than that by participants who watched a realistic video (P<.001). There were no significant group differences with regard to hypothetical decision making and attitude toward the intervention. In addition, we did not identify any influence of the visualization format on knowledge acquisition. In Study 2, 58 of 110 participants (52.7%) indicated that they would prefer a schematic visualization, 26 (23.6%) preferred a realistic visualization, 17 (15.5%) wanted either visualization, and 9 (8.2%) did not want to watch a video at all. Of the participants who wanted to watch a video, 91 (90.1%) preferred to have navigational options, 3 (3.0%) preferred not to have navigational options, and 7 (6.9%) did not mind the options.
CONCLUSION


Our study indicates that the perception of medical information videos is influenced by their design. Schematic videos with navigational options are the most helpful among all videos to avoid negative emotions and support knowledge acquisition when informing patients about an intervention. The visualization format and navigational options are important features that should be considered when designing medical videos for patient education.
TRIAL REGISTRATION


Deutsches Register Klinischer Studien DRKS00016003; https://www.drks.de/drks_web/ navigate.do?navigationId= trial.HTML&TRIAL_ID=DRKS00016003 (Archived by WebCite at http://www.webcitation.org/746ASSAhN).",2018,A realistic visualization induced more fear (P=.001) and disgust (P<.001) than a schematic video.,"[""Laypeople's Perception and Preference of Surgery Information Videos"", 'participants who used navigational options (n=36) gained significantly more factual knowledge (P=.005) and procedural knowledge (P<.001) than participants who did not have or use navigational options (n=115', 'participants who wanted to watch a video, 91 (90.1%) preferred to have navigational options, 3 (3.0%) preferred not to have navigational options, and 7 (6.9%) did not mind the options', '151 participants watched 1 of 4', 'All participants were medical laypeople without personal experience with a cruciate ligament rupture and were presented with a fictional decision situation', '110 participants indicated their preference for a video design']","['cruciate ligament surgery', 'videos (schematic vs realistic visualization; available vs unavailable navigational options', 'Visualization Format and Navigational Options']",[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0263791', 'cui_str': 'Rupture of cruciate ligaments'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0686905', 'cui_str': 'Unavailability'}, {'cui': 'C1301627', 'cui_str': 'Format'}]",[],151.0,0.0675548,A realistic visualization induced more fear (P=.001) and disgust (P<.001) than a schematic video.,"[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Eggeling', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut fuer Wissensmedien, Tuebingen, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Bientzle', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut fuer Wissensmedien, Tuebingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Shiozawa', 'Affiliation': 'Institute of Clinical Anatomy and Cell Analysis, Eberhard Karls University Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Cress', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut fuer Wissensmedien, Tuebingen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Kimmerle', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut fuer Wissensmedien, Tuebingen, Germany.'}]",Journal of participatory medicine,['10.2196/12338']
2569,33052289,Does Deep Neuromuscular Blockade Improve Operating Conditions during Minimally Invasive Anterolateral Total Hip Replacements?: A Randomized Controlled Trial.,"Background Neuromuscular blockade (NMB) is thought to improve operative conditions during certain procedures. Published descriptions of minimally invasive hip replacement techniques specify the need for ""excellent relaxation"", however, the optimal degree of NMB required for such cases has not been studied. We performed a randomized, single-blind study comparing the effect of moderate and deep neuromuscular blockade on surgical conditions and operating time during minimally invasive anterolateral hip replacement. Vecuronium was administered to maintain moderate NMB (train-of-four count of 1-2) or deep NMB (train-of-four count of 0, post-tetanic count of 1-2). Methods In this study, 116 patients were randomized to receive moderate or deep neuromuscular blockade; depth of blockade was monitored using acceleromyography. The primary outcome was the number of requests from the surgeon for additional blockade intraoperatively. Secondary outcomes included operative times and assessment of the operative conditions by the surgeon utilizing the Leiden-Surgical Rating Scale. Results Cases with additional requests for blockade did not differ between the deep and moderate NMB groups (11/58, 19.0% vs 8/58, 13.8%); relative risk, 1.22 (95% CI [confidence interval], 0.70-2.15), p=0.62. Neither time from incision to prosthesis reduction (33.8±1.2 min vs. 32.6 ±1.2 min; difference in geometric mean, 0.96 [95% CI, 0.90-1.04] minutes, p=0.33), nor the surgeon's assessment of operative conditions (p=0.88), differed between the deep or moderate NMB groups, respectively.  Conclusions Deep NMB did not produce significantly improved operative conditions compared with moderate NMB. Routine use of deep NMB during minimally invasive anterolateral hip arthroplasty is not supported by this study.",2020,"Results Cases with additional requests for blockade did not differ between the deep and moderate NMB groups (11/58, 19.0% vs 8/58, 13.8%); relative risk, 1.22 (95% CI [confidence interval], 0.70-2.15), p=0.62.","['minimally invasive anterolateral hip replacement', '116 patients']","['Vecuronium', 'moderate or deep neuromuscular blockade; depth of blockade was monitored using acceleromyography', ' Neuromuscular blockade (NMB', 'moderate and deep neuromuscular blockade', 'deep NMB']","['operative times and assessment of the operative conditions by the surgeon utilizing the Leiden-Surgical Rating Scale', 'surgical conditions and operating time', 'number of requests from the surgeon for additional blockade intraoperatively', 'time from incision to prosthesis reduction', 'operative conditions', ""surgeon's assessment of operative conditions""]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C0392806', 'cui_str': 'Insertion of hip prosthesis'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0242531', 'cui_str': 'Vecuronium'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C3805242', 'cui_str': 'Acceleromyography'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",116.0,0.190916,"Results Cases with additional requests for blockade did not differ between the deep and moderate NMB groups (11/58, 19.0% vs 8/58, 13.8%); relative risk, 1.22 (95% CI [confidence interval], 0.70-2.15), p=0.62.","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Curry', 'Affiliation': 'Anesthesiology and Perioperative Medicine, Maine Medical Center, Portland, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Steen', 'Affiliation': 'Anesthesiology and Perioperative Medicine, Maine Medical Center, Portland, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Craig', 'Affiliation': 'Center for Outcomes Research and Evaluation, Maine Medical Center Research Institute, Portland, USA.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Cary', 'Affiliation': 'Anesthesiology and Perioperative Medicine, Maine Medical Center, Portland, USA.'}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Richard', 'Affiliation': 'Anesthesiology and Perioperative Medicine, Maine Medical Center, Portland, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Babikian', 'Affiliation': 'Orthopaedic Surgery, Maine Medical Center, Portland, USA.'}]",Cureus,['10.7759/cureus.10328']
2570,33052382,Effect of Risankizumab on Patient-Reported Outcomes in Moderate to Severe Psoriasis: The UltIMMa-1 and UltIMMa-2 Randomized Clinical Trials.,"Importance


Demonstrating the value of therapies from a patient's perspective is increasingly important for patient-centered care.
Objective


To compare patient-reported outcomes (PROs) with risankizumab vs ustekinumab and placebo in psoriasis symptoms, health-related quality of life (HRQL), and mental health among patients with moderate to severe psoriasis.
Design, Setting, and Participants


The UltIMMa-1 and UltIMMa-2 studies were replicate 52-week phase 3, randomized, multisite, double-blind, placebo-controlled and active comparator-controlled trials conducted in 139 sites (including hospitals, academic medical centers, clinical research units, and private practices) globally in Asia-Pacific, Japan, Europe, and North America. Adults (≥18 years) with moderate to severe chronic plaque psoriasis with body surface area (BSA) involvement of 10% or more, Psoriasis Area Severity Index (PASI) scores of 12 or higher, and static Physician's Global Assessment (sPGA) scores of 3 or higher were included.
Interventions


In each trial, patients were randomly assigned (3:1:1) to 150 mg of risankizumab, 45 mg or 90 mg of ustekinumab (weight-based per label) for 52 weeks, or matching placebo for 16 weeks followed by risankizumab.
Main Outcomes and Measures


Integrated data from 2 trials were used to compare Psoriasis Symptom Scale (PSS) (total score and item scores for pain, redness, itchiness, and burning), Dermatology Life Quality Index (DLQI), 5-level EuroQoL-5D (EQ-5D-5L), and Hospital Anxiety and Depression Scale (HADS), at baseline, week 16, and week 52.
Results


A total of 997 patients with moderate to severe chronic plaque psoriasis were analyzed. Across all arms, the mean age was 47.2 to 47.8 years and 68.3% (136/199 for ustekinumab) to 73.0% (146/200 for placebo) were men. Patients' characteristics and PROs were comparable across all treatment arms at baseline (n = 598, 199, 200 for risankizumab, ustekinumab, and placebo, respectively). At week 16, a significantly greater proportion of patients treated with risankizumab than those treated with ustekinumab or placebo achieved PSS = 0, indicating no psoriasis symptoms (30.3% [181/598], 15.1% [30/199], 1.0% [2/200], both P < .001), and DLQI = 0 or 1 indicating no impact on skin-related HRQL (66.2%, 44.7%, 6.0%, P < .001). Significantly greater proportions of patients treated with risankizumab achieved minimally clinically important difference (MCID) than ustekinumab or placebo for DLQI (94.5% [516/546], 85.1% [149/175], 35.6% [64/180]; both P < .001), EQ-5D-5L (41.7% [249/597] vs 31.5% [62/197], P = .01; vs 19.0% [38/200], P < .001), and HADS (anxiety: 69.1% [381/551] vs 57.1% [104/182], P = .004; vs 35.9% [66/184], P < .001; depression: 71.1% [354/598] vs 60.4% [96/159], P = .01; vs 37.1% [59/159], P < .001). At week 52, improvements in patients treated with risankizumab compared with those treated with ustekinumab were sustained for PSS, DLQI, and EQ-5D-5L.
Conclusions and Relevance


Risankizumab significantly improved symptoms of moderate to severe psoriasis, improved HRQL, and reduced psychological distress compared with ustekinumab or placebo.
Trial Registration


ClinicalTrials.gov Identifiers: NCT02684370 (UltIMMa-1) and NCT02684357 (UltIMMa-2).",2020,"Patients' characteristics and PROs were comparable across all treatment arms at baseline (n = 598, 199, 200 for risankizumab, ustekinumab, and placebo, respectively).","['Adults (≥18 years) with moderate to severe chronic plaque psoriasis with body surface area (BSA) involvement of 10% or more', 'patients with moderate to severe psoriasis', 'Moderate to Severe Psoriasis', 'controlled and active comparator-controlled trials conducted in 139 sites (including hospitals, academic medical centers, clinical research units, and private practices) globally in Asia-Pacific, Japan, Europe, and North America', 'mean age was 47.2 to 47.8 years and 68.3% (136/199 for ustekinumab) to 73.0% (146/200 for', '997 patients with moderate to severe chronic plaque psoriasis']","['risankizumab', 'risankizumab, 45 mg or 90 mg of ustekinumab (weight-based per label) for 52 weeks, or matching placebo', 'placebo', 'Risankizumab', 'ustekinumab or placebo', 'risankizumab vs ustekinumab and placebo']","['symptoms of moderate to severe psoriasis, improved HRQL, and reduced psychological distress', 'psoriasis symptoms, health-related quality of life (HRQL), and mental health', 'Psoriasis Symptom Scale (PSS) (total score and item scores for pain, redness, itchiness, and burning), Dermatology Life Quality Index (DLQI), 5-level EuroQoL-5D (EQ-5D-5L), and Hospital Anxiety and Depression Scale (HADS', 'EQ-5D-5L', 'psoriasis symptoms', "" Psoriasis Area Severity Index (PASI) scores of 12 or higher, and static Physician's Global Assessment (sPGA) scores"", 'skin-related HRQL']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C4505511', 'cui_str': 'risankizumab'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",997.0,0.501421,"Patients' characteristics and PROs were comparable across all treatment arms at baseline (n = 598, 199, 200 for risankizumab, ustekinumab, and placebo, respectively).","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'University Medical Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Lambert', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Zema', 'Affiliation': 'Formerly AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Elizabeth H Z', 'Initials': 'EHZ', 'LastName': 'Thompson', 'Affiliation': 'Formerly AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Analysis Group, Inc, Boston, Massachusetts.'}, {'ForeName': 'Eric Q', 'Initials': 'EQ', 'LastName': 'Wu', 'Affiliation': 'Analysis Group, Inc, Boston, Massachusetts.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Garcia-Horton', 'Affiliation': 'Analysis Group, Inc, New York, New York.'}, {'ForeName': 'Ziqian', 'Initials': 'Z', 'LastName': 'Geng', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Joaquin M', 'Initials': 'JM', 'LastName': 'Valdes', 'Affiliation': 'Formerly AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Avani', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Gordon', 'Affiliation': 'Medical College of Wisconsin, Milwaukee.'}]",JAMA dermatology,['10.1001/jamadermatol.2020.3617']
2571,33052400,Effect of Tropisetron on Prevention of Emergence Delirium in Patients After Noncardiac Surgery: A Trial Protocol.,"Importance


Postoperative delirium is a frequent disorder for patients undergoing surgery and is associated with poor outcomes. Delirium may occur in the immediate period after anesthesia administration and surgery. Tropisetron, which is frequently administrated for postoperative nausea and vomiting, is also a partial agonist of α7 nicotinic acetylcholine receptors associated with neuroprotective effects. Tropisetron may be the potential pharmacological treatment to decrease delirium after noncardiac surgery.
Objective


To perform a randomized clinical trial to determine the efficacy and safety of tropisetron for prevention of emergence delirium in patients undergoing noncardiac surgery.
Design, Setting, and Participants


This single-center, 2-arm randomized, double-blind, placebo-controlled trial will include 1508 patients undergoing noncardiac surgery. The intervention group will receive 5 mg of intravenous tropisetron before anesthesia induction, and patients in the control group will receive a placebo. The primary end point is the incidence of emergence delirium within 1 hour after tracheal tube removal, measured by the Confusion Assessment Method for the Intensive Care Unit score. The main secondary outcome is the incidence of postoperative delirium measured at 3 days of follow-up. An intention-to-treat principle will be used for all analyses.
Discussion


Delirium remains the most common neuropsychiatric complication for patients after surgery. This will be the first randomized clinical study to evaluate whether tropisetron is effective in preventing emergence delirium. Results from this study will provide evidence for alteration of daily practice.
Trial Registration


ClinicalTrials.gov Identifier: NCT04027751.",2020,"Tropisetron, which is frequently administrated for postoperative nausea and vomiting, is also a partial agonist of α7 nicotinic acetylcholine receptors associated with neuroprotective effects.","['patients after surgery', 'patients undergoing surgery', 'Patients', '1508 patients undergoing noncardiac surgery', 'patients undergoing noncardiac surgery']","['Tropisetron', 'placebo', 'tropisetron']","['incidence of postoperative delirium', 'efficacy and safety', 'Emergence Delirium', 'incidence of emergence delirium within 1 hour after tracheal tube removal, measured by the Confusion Assessment Method for the Intensive Care Unit score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0063322', 'cui_str': 'tropisetron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C1260970', 'cui_str': 'Tracheal tube'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",1508.0,0.696369,"Tropisetron, which is frequently administrated for postoperative nausea and vomiting, is also a partial agonist of α7 nicotinic acetylcholine receptors associated with neuroprotective effects.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Mengwen', 'Initials': 'M', 'LastName': 'Geng', 'Affiliation': 'Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Xue', 'Affiliation': 'Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yayun', 'Initials': 'Y', 'LastName': 'Lang', 'Affiliation': 'Department of Anesthesiology, Beijing Civil Aviation General Hospital, Beijing, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': 'Department of Anesthesiology, Beijing Huairou District Hospital of Traditional Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Hao', 'Affiliation': 'Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Mu', 'Affiliation': 'Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Lirong', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Department of Clinical Epidemiology and Tobacco Dependence Treatment Research, Beijing Chao-Yang Hospital, Capital Medical University, Beijing Institute of Respiratory Medicine, Beijing, China.'}, {'ForeName': 'Anshi', 'Initials': 'A', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.13443']
2572,33052404,Feasibility and Efficacy of a Resiliency Intervention for the Prevention of Chronic Emotional Distress Among Survivor-Caregiver Dyads Admitted to the Neuroscience Intensive Care Unit: A Randomized Clinical Trial.,"Importance


To our knowledge, there are no evidence-based interventions to prevent chronic emotional distress (ie, depression, anxiety, and posttraumatic stress [PTS]) in critical care survivors and their informal caregivers.
Objective


To determine the feasibility and preliminary effect of the novel dyadic resiliency intervention Recovering Together (RT) on reducing symptoms of depression, anxiety, and PTS among hospitalized patients and their informal caregivers.
Design, Setting, and Participants


This single-blind, pilot randomized clinical trial of RT vs an educational control was conducted among 58 dyads in which either the survivor or caregiver endorsed clinically significant symptoms of depression, anxiety, or PTS. The study was conducted in the neuroscience intensive care unit at Massachusetts General Hospital. Data were collected from September 2019 to March 2020.
Interventions


Both RT and control programs had 6 sessions (2 at bedside and 4 via live video after discharge), and both survivor and caregiver participated together.
Main Outcomes and Measures


The primary outcomes were feasibility of recruitment and intervention delivery, credibility, and satisfaction. The secondary outcomes included depression and anxiety (measured by the Hospital Depression and Anxiety Scale), PTS (measured by the PTSD Checklist-Civilian Version), and intervention targets (ie, mindfulness, measured by the Cognitive and Affective Mindfulness Scale-Revised; coping, measured by the Measure of Current Status-Part A; and dyadic interpersonal interactions, measured by the Dyadic Relationship Scale). Main outcomes and targets were assessed at baseline, 6 weeks, and 12 weeks.
Results


The 58 dyads were randomized to RT (29 dyads [50.0%]; survivors: mean [SD] age, 49.3 [16.7] years; 9 [31.0%] women; caregivers: mean [SD] age, 52.4 [14.3] years; 22 [75.9%] women) or control (29 dyads [50.0%]; survivors: mean [SD] age, 50.3 [16.4] years; 12 [41.3%] women; caregivers, mean [SD] age, 52.1 [14.9], 17 [58.6%] women). Feasibility (recruitment [76%], randomization [100%], and data collection [83%-100%]), adherence (86%), fidelity (100%; κ = 0.98), satisfaction (RT: 57 of 58 [98%] with scores >6; control: 58 of 58 [100%] with scores >6), credibility (RT: 47 of 58 [81%] with scores >6; control: 46 of 58 [80%] with scores >6), and expectancy (RT: 49 of 58 [85%] with scores >13.5; 51 of 58 [87%] with scores >13.5) exceeded benchmarks set a priori. Participation in RT was associated with statistically and clinically significant improvement between baseline and postintervention in symptoms of depression (among survivors: -4.0 vs -0.6; difference, -3.4; 95% CI, -5.6 to -1.3; P = .002; among caregivers: -3.8 vs 0.6; difference, -4.5; 95% CI, -6.7 to -2.3; P < .001), anxiety (among survivors: -6.0 vs 0.3; difference, -6.3; 95% CI, -8.8 to -3.8; P < .001; among caregivers: -5.0 vs -0.9; difference, -4.1; 95% CI, -6.7 to -1.5, P = .002), and PTS (among survivors: -11.3 vs 1.0; difference, -12.3; 95% CI, -18.1 to -6.5, P < .001; among caregivers, -11.4 vs 5.0; difference, -16.4, 95% CI, -21.8 to -10.9; P < .001). Improvements sustained through the 12-week follow-up visit. We also observed RT-dependent improvement in dyadic interpersonal interactions for survivors (0.2 vs -0.2; difference, 0.4; 95% CI, 0.0 to 0.8; P = .04).
Conclusions and Relevance


In this pilot randomized clinical trial, RT was feasible and potentially efficacious in preventing chronic emotional distress in dyads of survivors of the neuroscience intensive care unit and their informal caregivers.
Trial Registration


ClinicalTrials.gov Identifier: NCT03694678.",2020,"In this pilot randomized clinical trial, RT was feasible and potentially efficacious in preventing chronic emotional distress in dyads of survivors of the neuroscience intensive care unit and their informal caregivers.
","['dyads of survivors of the neuroscience intensive care unit and their informal caregivers', 'Survivor-Caregiver Dyads Admitted to the Neuroscience Intensive Care Unit', 'hospitalized patients and their informal caregivers', '58 dyads were randomized to RT (29 dyads [50.0%]; survivors: mean [SD] age, 49.3 [16.7] years; 9 [31.0%] women; caregivers: mean [SD] age, 52.4 [14.3] years; 22 [75.9%] women) or control (29 dyads [50.0%]; survivors: mean [SD] age, 50.3 [16.4] years; 12 [41.3%] women; caregivers, mean [SD] age, 52.1 [14.9], 17 [58.6%] women', '58 dyads in which either the survivor or caregiver endorsed clinically significant symptoms of depression, anxiety, or PTS', 'neuroscience intensive care unit at Massachusetts General Hospital']","['Resiliency Intervention', 'RT', 'novel dyadic resiliency intervention Recovering Together (RT']","['fidelity', 'feasibility of recruitment and intervention delivery, credibility, and satisfaction', 'depression and anxiety (measured by the Hospital Depression and Anxiety Scale), PTS (measured by the PTSD Checklist-Civilian Version), and intervention targets (ie, mindfulness, measured by the Cognitive and Affective Mindfulness Scale-Revised; coping, measured by the Measure of Current Status-Part A; and dyadic interpersonal interactions, measured by the Dyadic Relationship Scale', 'adherence', 'symptoms of depression', 'Feasibility and Efficacy', 'chronic emotional distress', 'Chronic Emotional Distress', 'dyadic interpersonal interactions', 'symptoms of depression, anxiety, and PTS', 'anxiety']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517770', 'cui_str': '41.3'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}]",58.0,0.167253,"In this pilot randomized clinical trial, RT was feasible and potentially efficacious in preventing chronic emotional distress in dyads of survivors of the neuroscience intensive care unit and their informal caregivers.
","[{'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bannon', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Mace', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Lester', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Meyers', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Gates', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Popok', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Salgueiro', 'Affiliation': 'Neuroscience Intensive Care Unit, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Tehan', 'Affiliation': 'Neuroscience Intensive Care Unit, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Macklin', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rosand', 'Affiliation': 'Henry and Allison McCance Center for Brain Health, Massachusetts General Hospital, Boston.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.20807']
2573,33052491,Effect of a 6-week and 12-week cardiac rehabilitation program on heart rate recovery.,"BACKGROUND


Cardiac rehabilitation has been shown to reduce cardiac mortality, improve quality of life, and reduce hospitalizations. Cardiac rehabilitation programs are usually performed over a 12-week period. Studies have shown that similar benefits could be achieved with shorter programs. Abnormal heart rate recovery after exercise has been associated with an increased risk of cardiovascular events and mortality. The main aim of this study was to compare the effect of a 6-week phase 2 cardiac rehabilitation program on heart rate recovery to a 12-week one in patients who had recovered from an anterior wall ST segment elevation myocardial infarction.
RESULTS


This prospective study included 60 patients enrolled in cardiac rehabilitation programs randomized into two equal groups: a 6-week and a 12-week program. Baseline patient demographics, lipid profile, and left ventricular ejection fraction (LVEF) were assessed. METs achieved, total exercise time, resting heart rate, peak heart rate, and heart rate recovery at 1 min were examined. These were re-assessed at the end of each program. Results showed no difference between both groups at the end of each program regarding lipid profile and LVEF. Patients enrolled in the 12-week cardiac rehabilitation program were able to achieve more METs, had a longer exercise time, a higher peak heart rate, and had a lower resting heart rate at the end of the program. Heart rate recovery was slightly higher in patients enrolled in the 6-week program 26.5 ± 6.78 versus 23.17 ± 6.12 bpm (p = 0.051). On comparing the magnitude of change between both programs, those in the 12-week program had more increase in HDL-C levels, METs achieved, and exercise time. Additionally, they had more reduction of resting heart rate. Heart rate recovery was more increased for those in the 6-week program.
CONCLUSION


Although heart rate recovery increases after completion of each of a 6-week and 12-week cardiac rehabilitation program compared to their baseline, there is no difference on comparing heart rate recovery between both programs at their end. Patients enrolled in a standard 12-week cardiac rehabilitation program achieve more METs, have a longer exercise time, a higher peak HR, and a lower resting HR at the end of the program compared to those in the 6-week program.",2020,"Patients enrolled in the 12-week cardiac rehabilitation program were able to achieve more METs, had a longer exercise time, a higher peak heart rate, and had a lower resting heart rate at the end of the program.","['60 patients enrolled in cardiac rehabilitation programs', 'patients who had recovered from an anterior wall ST segment elevation myocardial infarction']",['cardiac rehabilitation program'],"['HDL-C levels, METs achieved, and exercise time', 'Baseline patient demographics, lipid profile, and left ventricular ejection fraction (LVEF', 'cardiac mortality', 'total exercise time, resting heart rate, peak heart rate, and heart rate recovery', 'resting heart rate', 'Heart rate recovery', 'lipid profile and LVEF', 'heart rate recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0442070', 'cui_str': 'Anterior wall'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0429931', 'cui_str': 'Total exercise time'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",60.0,0.0115637,"Patients enrolled in the 12-week cardiac rehabilitation program were able to achieve more METs, had a longer exercise time, a higher peak heart rate, and had a lower resting heart rate at the end of the program.","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El Missiri', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt. amissiri@med.asu.edu.eg.'}, {'ForeName': 'Sameh Atteya', 'Initials': 'SA', 'LastName': 'Amin', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt.'}, {'ForeName': 'Islam Reda', 'Initials': 'IR', 'LastName': 'Tawfik', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt.'}, {'ForeName': 'Adel Mohamed', 'Initials': 'AM', 'LastName': 'Shabana', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt.'}]",The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology,['10.1186/s43044-020-00107-8']
2574,33052539,Inhaler Technique and Self-reported Adherence to Medications Among Hospitalised People with Asthma and COPD.,"BACKGROUND


Metered dose inhalers (MDIs) and dry powder inhalers (DPIs) are devices used for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Inhaler technique is important since incorrect technique can lead to a poorer prognosis and hospitalization.
OBJECTIVE


The objective of this study was to investigate the inhaler technique and overall adherence to medications in an adult population with asthma and COPD.
PATIENTS AND METHODS


Those invited to participate were people admitted to Umeå University Hospital in northern Sweden in October, November and December 2018, with inhaled medication prescribed prior to admission. Inhaler technique was assessed using checklists and observations with placebo-inhalers were conducted. The Medication Adherence Report Scale (MARS)-5 was used to measure self-reported overall adherence to drug medication.
RESULTS


Of the 23 people included in the study, 26.1% had one or more critical errors in inhaler technique and 30.4% were considered overall non-adherent to drug medication. Among the 23 participants, the mean age, and the number of regularly prescribed medications were higher among those with poor inhaler technique than among people with no error in their inhaler technique.
CONCLUSION


This study indicates that poor inhaler technique and overall non-adherence to medications occur among hospitalised people with asthma and COPD living in northern Sweden. Interventions to improve inhaler technique and adherence to drugs are needed.",2020,"Among the 23 participants, the mean age, and the number of regularly prescribed medications were higher among those with poor inhaler technique than among people with no error in their inhaler technique.
","['asthma and chronic obstructive pulmonary disease (COPD', 'hospitalised people with asthma and COPD living in northern Sweden', 'adult population with asthma and COPD', 'Hospitalised People with Asthma and COPD', 'Those invited to participate were people admitted to Umeå University Hospital in northern Sweden in October, November and December 2018, with inhaled medication prescribed prior to admission']",[],[],"[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0332152', 'cui_str': 'Before'}]",[],[],,0.0436148,"Among the 23 participants, the mean age, and the number of regularly prescribed medications were higher among those with poor inhaler technique than among people with no error in their inhaler technique.
","[{'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Elander', 'Affiliation': 'Department of Integrative Medical Biology, Umeå University, 90187, Umeå, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Integrative Medical Biology, Umeå University, 90187, Umeå, Sweden. maria.gustafsson@umu.se.'}]",Drugs - real world outcomes,['10.1007/s40801-020-00210-x']
2575,33052555,Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study.,"PURPOSE


In the phase III CLARINET study (NCT00353496), lanreotide autogel/depot (lanreotide) significantly improved progression-free survival (PFS) vs placebo in patients with non-functioning intestinal or pancreatic neuroendocrine tumours (NETs). The aim of CLARINET open-label extension (OLE) (NCT00842348) was to evaluate long-term safety and efficacy of lanreotide in these patients.
METHODS


Patients from the CLARINET study were eligible for the OLE if they had stable disease (irrespective of treatment group) or progressive disease (PD) (placebo-treated patients only). All patients in the OLE received lanreotide 120 mg every 28 days. Computed tomography or magnetic resonance imaging scans were conducted every 6 months and assessed locally for PD (the final scan was also assessed centrally).
RESULTS


Overall, 89 patients took part in the OLE (lanreotide, n = 42; placebo, n = 47). Median (range) exposure to lanreotide in patients who received lanreotide in the core study and OLE (LAN-LAN group) was 59.0 (26.0-102.3) months. In this group, the overall incidences of adverse events (AEs) and treatment-related AEs were lower in the OLE than in the core study. Median [95% CI] PFS in the LAN-LAN group was 38.5 [30.9; 59.4] months. In placebo-treated patients with PD at the end of the core study, time to death or subsequent PD during the OLE was 19 [10.1; 26.7] months.
CONCLUSIONS


This study provides new evidence on the long-term safety profile and sustained anti-tumour effects of lanreotide autogel/depot in indolent and progressive metastatic intestinal or pancreatic NETs.",2020,"In this group, the overall incidences of adverse events (AEs) and treatment-related AEs were lower in the OLE than in the core study.","['Patients from the CLARINET study were eligible for the OLE if they had stable disease (irrespective of treatment group) or progressive disease (PD) (placebo-treated patients only', 'advanced enteropancreatic neuroendocrine tumours', 'patients with non-functioning intestinal or pancreatic neuroendocrine tumours (NETs', '89 patients took part in the', 'indolent and progressive metastatic intestinal or pancreatic NETs']","['Computed tomography or magnetic resonance imaging scans', 'lanreotide autogel/depot (lanreotide', 'OLE (lanreotide', 'Lanreotide autogel/depot', 'placebo', 'lanreotide autogel/depot', 'lanreotide']","['overall incidences of adverse events (AEs) and treatment-related AEs', 'progression-free survival (PFS', 'time to death or subsequent PD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0242363', 'cui_str': 'Pancreatic endocrine tumor'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.113599,"In this group, the overall incidences of adverse events (AEs) and treatment-related AEs were lower in the OLE than in the core study.","[{'ForeName': 'Martyn E', 'Initials': 'ME', 'LastName': 'Caplin', 'Affiliation': 'Department of Gastroenterology and Tumour Neuroendocrinology, Royal Free Hospital, London, UK. m.caplin@ucl.ac.uk.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Pavel', 'Affiliation': 'Department of Medicine, Division of Endocrinology and Diabetology, Universitätsklinikum Erlangen, Friedrich Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Alexandria T', 'Initials': 'AT', 'LastName': 'Phan', 'Affiliation': 'Department of Hematology-Oncology, University of Texas Health Science Center at Tyler, Tyler, TX, USA.'}, {'ForeName': 'Jarosław B', 'Initials': 'JB', 'LastName': 'Ćwikła', 'Affiliation': 'Department of Cardiology and Cardiac Surgery, School of Medicine, University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Sedláčková', 'Affiliation': 'Department of Oncology, First Faculty of Medicine and General Teaching Hospital, Prague, Czech Republic.'}, {'ForeName': 'Xuan-Mai Truong', 'Initials': 'XT', 'LastName': 'Thanh', 'Affiliation': 'Medical Affairs, Ipsen Pharma, Boulogne-Billancourt, France.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Wolin', 'Affiliation': 'Tisch Cancer Institute at Mount Sinai and Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Ruszniewski', 'Affiliation': 'Division of Gastroenterology and Pancreatology, Beaujon Hospital, Clichy, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Endocrine,['10.1007/s12020-020-02475-2']
2576,33052602,Electronic cigarettes for smoking cessation.,"BACKGROUND


Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol formed by heating an e-liquid. People who smoke report using ECs to stop or reduce smoking, but some organisations, advocacy groups and policymakers have discouraged this, citing lack of evidence of efficacy and safety. People who smoke, healthcare providers and regulators want to know if ECs can help people quit and if they are safe to use for this purpose. This review is an update of a review first published in 2014.
OBJECTIVES


To evaluate the effect and safety of using electronic cigarettes (ECs) to help people who smoke achieve long-term smoking abstinence.
SEARCH METHODS


We searched the Cochrane Tobacco Addiction Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO for relevant records to January 2020, together with reference-checking and contact with study authors.
SELECTION CRITERIA


We included randomized controlled trials (RCTs) and randomized cross-over trials in which people who smoke were randomized to an EC or control condition. We also included uncontrolled intervention studies in which all participants received an EC intervention. To be included, studies had to report abstinence from cigarettes at six months or longer and/or data on adverse events (AEs) or other markers of safety at one week or longer.
DATA COLLECTION AND ANALYSIS


We followed standard Cochrane methods for screening and data extraction. Our primary outcome measures were abstinence from smoking after at least six months follow-up, AEs, and serious adverse events (SAEs). Secondary outcomes included changes in carbon monoxide, blood pressure, heart rate, blood oxygen saturation, lung function, and levels of known carcinogens/toxicants. We used a fixed-effect Mantel-Haenszel model to calculate the risk ratio (RR) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data from these studies in meta-analyses.
MAIN RESULTS


We include 50 completed studies, representing 12,430 participants, of which 26 are RCTs. Thirty-five of the 50 included studies are new to this review update. Of the included studies, we rated four (all which contribute to our main comparisons) at low risk of bias overall, 37 at high risk overall (including the 24 non-randomized studies), and the remainder at unclear risk. There was moderate-certainty evidence, limited by imprecision, that quit rates were higher in people randomized to nicotine EC than in those randomized to nicotine replacement therapy (NRT) (risk ratio (RR) 1.69, 95% confidence interval (CI) 1.25 to 2.27; I 2  = 0%; 3 studies, 1498 participants). In absolute terms, this might translate to an additional four successful quitters per 100 (95% CI 2 to 8). There was low-certainty evidence (limited by very serious imprecision) of no difference in the rate of adverse events (AEs) (RR 0.98, 95% CI 0.80 to 1.19; I 2  = 0%; 2 studies, 485 participants). SAEs occurred rarely, with no evidence that their frequency differed between nicotine EC and NRT, but very serious imprecision led to low certainty in this finding (RR 1.37, 95% CI 0.77 to 2.41: I 2  = n/a; 2 studies, 727 participants). There was moderate-certainty evidence, again limited by imprecision, that quit rates were higher in people randomized to nicotine EC than to non-nicotine EC (RR 1.71, 95% CI 1.00 to 2.92; I 2  = 0%; 3 studies, 802 participants). In absolute terms, this might again lead to an additional four successful quitters per 100 (95% CI 0 to 12). These trials used EC with relatively low nicotine delivery. There was low-certainty evidence, limited by very serious imprecision, that there was no difference in the rate of AEs between these groups (RR 1.00, 95% CI 0.73 to 1.36; I 2  = 0%; 2 studies, 346 participants). There was insufficient evidence to determine whether rates of SAEs differed between groups, due to very serious imprecision (RR 0.25, 95% CI 0.03 to 2.19; I 2  = n/a; 4 studies, 494 participants). Compared to behavioural support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.50, 95% CI 1.24 to 5.04; I 2  = 0%; 4 studies, 2312 participants). In absolute terms this represents an increase of six per 100 (95% CI 1 to 14). However, this finding was very low-certainty, due to issues with imprecision and risk of bias. There was no evidence that the rate of SAEs varied, but some evidence that non-serious AEs were more common in people randomized to nicotine EC (AEs: RR 1.17, 95% CI 1.04 to 1.31; I 2  = 28%; 3 studies, 516 participants; SAEs: RR 1.33, 95% CI 0.25 to 6.96; I 2  = 17%; 5 studies, 842 participants). Data from non-randomized studies were consistent with RCT data. The most commonly reported AEs were throat/mouth irritation, headache, cough, and nausea, which tended to dissipate over time with continued use. Very few studies reported data on other outcomes or comparisons and hence evidence for these is limited, with confidence intervals often encompassing clinically significant harm and benefit.
AUTHORS' CONCLUSIONS


There is moderate-certainty evidence that ECs with nicotine increase quit rates compared to ECs without nicotine and compared to NRT. Evidence comparing nicotine EC with usual care/no treatment also suggests benefit, but is less certain. More studies are needed to confirm the degree of effect, particularly when using modern EC products. Confidence intervals were wide for data on AEs, SAEs and other safety markers. Overall incidence of SAEs was low across all study arms. We did not detect any clear evidence of harm from nicotine EC, but longest follow-up was two years and the overall number of studies was small. The main limitation of the evidence base remains imprecision due to the small number of RCTs, often with low event rates. Further RCTs are underway. To ensure the review continues to provide up-to-date information for decision-makers, this review is now a living systematic review. We will run searches monthly from December 2020, with the review updated as relevant new evidence becomes available. Please refer to the Cochrane Database of Systematic Reviews for the review's current status.",2020,"Compared to behavioural support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.50, 95% CI 1.24 to 5.04; I 2  = 0%; 4 studies, 2312 participants).","['people who smoke', '50 completed studies, representing 12,430 participants, of which 26 are RCTs', 'people who smoke achieve long-term smoking abstinence']","['nicotine EC', 'EC or control condition', 'Electronic cigarettes', 'EC intervention', 'electronic cigarettes (ECs', 'nicotine replacement therapy (NRT) (risk ratio (RR']","['quit rates', 'rates of SAEs', 'Overall incidence of SAEs', 'throat/mouth irritation, headache, cough, and nausea', 'rate of SAEs', 'rate of adverse events', 'abstinence from smoking after at least six months follow-up, AEs, and serious adverse events (SAEs', 'risk ratio (RR', 'rate of AEs', 'changes in carbon monoxide, blood pressure, heart rate, blood oxygen saturation, lung function, and levels of known carcinogens/toxicants']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0235339', 'cui_str': 'Mouth irritation'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0007090', 'cui_str': 'Carcinogen'}]",12430.0,0.543092,"Compared to behavioural support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.50, 95% CI 1.24 to 5.04; I 2  = 0%; 4 studies, 2312 participants).","[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Hartmann-Boyce', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Hayden', 'Initials': 'H', 'LastName': 'McRobbie', 'Affiliation': 'National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lindson', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Begh', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Theodoulou', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Notley', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Tobacco Research and Treatment Center, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Tari', 'Initials': 'T', 'LastName': 'Turner', 'Affiliation': 'Cochrane Australia, School of Public Health & Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Ailsa R', 'Initials': 'AR', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hajek', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts & The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD010216.pub4']
2577,33048619,Molecular Landscape and Actionable Alterations in a Genomically Guided Cancer Clinical Trial: National Cancer Institute Molecular Analysis for Therapy Choice (NCI-MATCH).,"PURPOSE


Therapeutically actionable molecular alterations are widely distributed across cancer types. The National Cancer Institute Molecular Analysis for Therapy Choice (NCI-MATCH) trial was designed to evaluate targeted therapy antitumor activity in underexplored cancer types. Tumor biopsy specimens were analyzed centrally with next-generation sequencing (NGS) in a master screening protocol. Patients with a tumor molecular alteration addressed by a targeted treatment lacking established efficacy in that tumor type were assigned to 1 of 30 treatments in parallel, single-arm, phase II subprotocols.
PATIENTS AND METHODS


Tumor biopsy specimens from 5,954 patients with refractory malignancies at 1,117 accrual sites were analyzed centrally with NGS and selected immunohistochemistry in a master screening protocol. The treatment-assignment rate to treatment arms was assessed. Molecular alterations in seven tumors profiled in both NCI-MATCH trial and The Cancer Genome Atlas (TCGA) of primary tumors were compared.
RESULTS


Molecular profiling was successful in 93.0% of specimens. An actionable alteration was found in 37.6%. After applying clinical and molecular exclusion criteria, 17.8% were assigned (26.4% could have been assigned if all subprotocols were available simultaneously). Eleven subprotocols reached their accrual goal as of this report. Actionability rates differed among histologies (eg, > 35% for urothelial cancers and < 6% for pancreatic and small-cell lung cancer). Multiple actionable or resistance-conferring tumor mutations were seen in 11.9% and 71.3% of specimens, respectively. Known resistance mutations to targeted therapies were numerically more frequent in NCI-MATCH than TCGA tumors, but not markedly so.
CONCLUSION


We demonstrated feasibility of screening large numbers of patients at numerous accruing sites in a complex trial to test investigational therapies for moderately frequent molecular targets. Co-occurring resistance mutations were common and endorse investigation of combination targeted-therapy regimens.",2020,"Known resistance mutations to targeted therapies were numerically more frequent in NCI-MATCH than TCGA tumors, but not markedly so.
","['Tumor biopsy specimens from 5,954 patients with refractory malignancies at 1,117 accrual sites were analyzed centrally with NGS and selected immunohistochemistry in a master screening protocol']",[],"['Actionability rates', 'Multiple actionable or resistance-conferring tumor mutations']","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0677862', 'cui_str': 'Biopsy sample'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C2936621', 'cui_str': 'Next-Generation Sequencing'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",[],"[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]",5954.0,0.0605508,"Known resistance mutations to targeted therapies were numerically more frequent in NCI-MATCH than TCGA tumors, but not markedly so.
","[{'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gray', 'Affiliation': 'ECOG-ACRIN Cancer Research Group Biostatistics Center, Dana Farber Cancer Institute Boston, MA.'}, {'ForeName': 'Alice P', 'Initials': 'AP', 'LastName': 'Chen', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'ECOG-ACRIN Cancer Research Group Biostatistics Center, Dana Farber Cancer Institute Boston, MA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'McShane', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Patton', 'Affiliation': 'Center for Biomedical Informatics and Information Technology, NCI, NIH, Bethesda, MD.'}, {'ForeName': 'Stanley R', 'Initials': 'SR', 'LastName': 'Hamilton', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'P Mickey', 'Initials': 'PM', 'LastName': 'Williams', 'Affiliation': 'Frederick National Laboratory for Cancer Research, Frederick, MD.'}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Iafrate', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Sklar', 'Affiliation': 'Yale University, New Haven, CT.'}, {'ForeName': 'Edith P', 'Initials': 'EP', 'LastName': 'Mitchell', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'Lyndsay N', 'Initials': 'LN', 'LastName': 'Harris', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Takebe', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Sims', 'Affiliation': 'Frederick National Laboratory for Cancer Research, Frederick, MD.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Coffey', 'Affiliation': 'Center for Biomedical Informatics and Information Technology, Frederick National Laboratory for Cancer Research, Frederick, MD.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Fu', 'Affiliation': 'Frederick National Laboratory for Cancer Research, Frederick, MD.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Routbort', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Zwiebel', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'Larry V', 'Initials': 'LV', 'LastName': 'Rubinstein', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Little', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'Carlos L', 'Initials': 'CL', 'LastName': 'Arteaga', 'Affiliation': 'University of Texas Southwestern Simmons Cancer Center, Dallas, TX.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Comis', 'Affiliation': 'ECOG-ACRIN Cancer Research Group, Philadelphia, PA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Abrams', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Dwyer"", 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Conley', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03010']
2578,33048635,Feasibility and Acceptability of an Interactive Cancer-Communication Video Program Using African American Breast Cancer Survivor Stories.,"To examine the feasibility and acceptability of an interactive video program of African American breast cancer survivor stories, we explored story reactions among African American women with newly diagnosed breast cancer and associations between patient factors and intervention use. During a randomized controlled trial, patients in the intervention arm completed a baseline/pre-intervention interview, received the video intervention, and completed a post-intervention 1-month follow-up interview. Additional video exposures and post-exposure interviews occurred at 6- and 12-month follow-ups. Multivariable linear mixed-effects models examined interview and clinical data in association with changes in minutes and actions using the program. After Exposure1, 104 of 108 patients allocated to the intervention reported moderate-to-high levels of positive emotional reactions to stories and identification with storytellers. Exposure1 mean usage was high (139 minutes) but declined over time ( p  <.0001). Patients receiving surgery plus radiation logged about 50 more minutes and actions over 12-month follow-up than patients receiving surgery only ( p  <.05); patients reporting greater trust in storytellers logged 18.6 fewer actions over time ( p  =.04). Patients' topical interests evolved, with patients watching more follow-up care and survivorship videos at Exposure3. The intervention was feasible and evaluated favorably. New videos might satisfy patients' changing interests.",2020,"After Exposure1, 104 of 108 patients allocated to the intervention reported moderate-to-high levels of positive emotional reactions to stories and identification with storytellers.","['African American women with newly diagnosed breast cancer and associations between patient factors and intervention use', 'African American breast cancer survivor stories']","['Interactive Cancer-Communication Video Program', 'baseline/pre-intervention interview, received the video intervention, and completed a post-intervention 1-month follow-up interview', 'interactive video program']","['Feasibility and Acceptability', 'moderate-to-high levels of positive emotional reactions to stories and identification with storytellers', 'feasibility and acceptability']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0221736', 'cui_str': 'Reaction emotional'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}]",,0.0261986,"After Exposure1, 104 of 108 patients allocated to the intervention reported moderate-to-high levels of positive emotional reactions to stories and identification with storytellers.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pérez', 'Affiliation': 'School of Medicine, Department of Medicine, Washington University in St. Louis , Saint Louis, Missouri, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Kreuter', 'Affiliation': 'The Brown School, Washington University in St. Louis , Saint Louis, Missouri, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine , Saint Louis, Missouri, USA.'}, {'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Thompson', 'Affiliation': 'The Brown School, Washington University in St. Louis , Saint Louis, Missouri, USA.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Sefko', 'Affiliation': 'School of Medicine, Department of Surgery, Washington University in St. Louis , St. Louis, Missouri, USA.'}, {'ForeName': 'Balaji', 'Initials': 'B', 'LastName': 'Golla', 'Affiliation': 'The Brown School, Washington University in St. Louis , Saint Louis, Missouri, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Margenthaler', 'Affiliation': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine , Saint Louis, Missouri, USA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Colditz', 'Affiliation': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine , Saint Louis, Missouri, USA.'}, {'ForeName': 'Donna B', 'Initials': 'DB', 'LastName': 'Jeffe', 'Affiliation': 'School of Medicine, Department of Medicine, Washington University in St. Louis , Saint Louis, Missouri, USA.'}]",Journal of health communication,['10.1080/10810730.2020.1821132']
2579,33048656,Mental health stigma among college students: Test of an interactive online intervention.,"OBJECTIVE


Young adults have low rates of help-seeking despite high rates of mental health problems, which relate to stigmatizing attitudes. Education as well as contact with people with mental health problems may improve stigmatization. The present pilot study tested the efficacy of an online interactive educational intervention that utilizes avatars depicting distressed individuals on stigmatizing attitudes toward mental illness and help-seeking.  Participants and Methods:  Eighty-five college student participants were assessed on self- and public-stigma as well as attitudes toward help-seeking and were randomly assigned to one of three conditions (intervention, control, post-test only).  Results:  Pre-post comparisons indicate that interactive programs may be an accessible and efficient means to reduce stigmatizing attitudes toward help-seeking among college students. Future studies should include follow-up assessments and measures of behavior and should consider individual differences. including personal mental health history.",2020,Pre-post comparisons indicate that interactive programs may be an accessible and efficient means to reduce stigmatizing attitudes toward help-seeking among college students.,"['Young adults', 'Participants and Methods:  Eighty-five college student participants were assessed on self- and public-stigma as well as attitudes toward help-seeking', 'college students', 'distressed individuals on stigmatizing attitudes toward mental illness and help-seeking']","['online interactive educational intervention', 'interactive online intervention']",['Mental health stigma'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]",85.0,0.0268226,Pre-post comparisons indicate that interactive programs may be an accessible and efficient means to reduce stigmatizing attitudes toward help-seeking among college students.,"[{'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Kirschner', 'Affiliation': 'Department of Psychology, Appalachian State University, Boone, North Carolina, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Goetzl', 'Affiliation': 'Department of Psychology, Appalachian State University, Boone, North Carolina, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Curtin', 'Affiliation': 'Department of Psychology, Appalachian State University, Boone, North Carolina, USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2020.1826492']
2580,33048829,Developing and Evaluating a Mobile Foot Care Application for Persons With Diabetes Mellitus: A Randomized Pilot Study.,"Ulceration of the foot is a major complication of diabetes mellitus, and optimal self-care may help prevent its development. Research suggests that mobile applications (apps) may affect behavioral change.
OBJECTIVE


The purpose of this study was to develop the Mobile Diabetic Foot Personal Care System (m-DAKBAS) and evaluate its effectiveness for patients with diabetes.
METHOD


During Phase 1, a mobile app that included communication features, remote patient monitoring, and information was developed and pilot-tested among 10 patients. The Phase 2 study, conducted from June 2017 to April 2018, used a 2-group, pre-test/post-test design to evaluate the effect of the app on patients' knowledge, behavior, and self-efficacy scores when used for 6 months. Both the experimental (app) and control groups participated in 1 education session at the start of the study.
RESULTS


Of 106 patients who enrolled, 88 completed the study (44 in the experimental group and 44 in the control group). Only 6 patients had received education about foot care previously. The average age of all participants was 51.63 years (SD = 8.08). There were significantly more women in the experimental group than in the control group (65% vs. 45.5%; P = 0.5). Each participant used the app for 24 weeks, and the data entry rate was 72.9%. Throughout the study, participants had 1977 data entries (blood glucose and foot observation) in total. Differences between pre- and post-intervention test scores were significantly higher for knowledge, behavior, and self-efficacy in both groups, but the difference was greater in the experimental group (P < .05). Only post-test knowledge scores were significantly higher in the experimental compared with the control group (P < .05). Compared to the start of the study, the proportion of participants with cracked/dry skin and inappropriate footwear was significantly lower in the experimental group but not in the control group.
CONCLUSION


In this study, education and follow-up via the mobile app and verbal-only instruction increased the knowledge, behavior, and self-efficacy scores of patients in both groups. Post-study knowledge scores were significantly higher in the experimental group than in the control group. Patient education remains a crucial component of optimal care, and further development, refinement, and testing of mobile applications to improve self-efficacy and reduce the risk of diabetic foot are warranted.",2020,Only post-test knowledge scores were significantly higher in the experimental compared with the control group (P < .05).,"['106 patients who enrolled, 88 completed the study (44 in the experimental group and 44 in the control group', 'Mellitus', 'participants had 1977 data entries (blood glucose and foot observation) in total', 'Persons With Diabetes', 'patients with diabetes']",['Mobile Foot Care Application'],"['knowledge, behavior, and self-efficacy scores', 'knowledge, behavior, and self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0150240', 'cui_str': 'Foot care'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0318699,Only post-test knowledge scores were significantly higher in the experimental compared with the control group (P < .05).,"[{'ForeName': 'Meryem', 'Initials': 'M', 'LastName': 'Kilic', 'Affiliation': 'Department of Nursing, Sanko University, Gaziantep, Turkey.'}, {'ForeName': 'Ayişe', 'Initials': 'A', 'LastName': 'Karadağ', 'Affiliation': 'Koç University School of Nursing, Istanbul, Turkey.'}]",Wound management & prevention,[]
2581,33062061,Quality of life after gastric bypass surgery in patients with type 2 diabetes: patients' experiences during 2 years of follow-up.,"Background


To examine the effects of gastric bypass surgery on health-related quality of life (HRQoL) in obese patients with type 2 diabetes, and to investigate their experiences of life adjustments using quantitative and qualitative methods.
Methods


Thirteen patients with type 2 diabetes and obesity, (body mass index, BMI > 30 kg/m 2 ), participating in a randomized clinical trial, completed this sub-study. HRQoL was evaluated before, and at 6 months and 2 years after gastric bypass surgery, using the RAND- 36-item health survey. At 2 years, interviews for in-depth analysis of HRQoL changes were performed.
Results


Significant improvement was observed from baseline to 6 months for 2 of the eight health concepts, general health, and emotional well-being. At 2 years, improvements were also seen in physical functioning, energy/fatigue, as well as sustained improvements in general health and emotional well-being. Multiple regression analyses showed mostly non-significant associations between the magnitude of decrease in weight, BMI, and HbA1c during follow-up and improvement in HRQoL. The analyses from qualitative interviews supported a common latent theme ""Finding a balance between the experience of the new body weight and self-confidence"".
Conclusions


The improved HRQoL after gastric bypass surgery in obese patients with type 2 diabetes was not explained specifically by the magnitude of weight loss, but rather by the participants achieving a state of union between body and consciousness. Trial registration  ClinicalTrials.gov Identifier NCT02729246. Date of registration 6 April 2016 - Retrospectively registered https://clinicaltrials.gov/ct2/show/NCT02729246?term=bariglykos&draw=2&rank=1.",2020,"At 2 years, improvements were also seen in physical functioning, energy/fatigue, as well as sustained improvements in general health and emotional well-being.","['obese patients with type 2 diabetes', 'Thirteen patients with type 2 diabetes and obesity, (body mass index, BMI\u2009>\u200930\xa0kg/m 2 ', 'patients with type 2 diabetes']",['gastric bypass surgery'],"['weight loss', 'general health and emotional well-being', 'physical functioning, energy/fatigue', 'health-related quality of life (HRQoL', 'HRQoL', 'weight, BMI, and HbA1c during follow-up and improvement in HRQoL', 'Quality of life']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",13.0,0.0506247,"At 2 years, improvements were also seen in physical functioning, energy/fatigue, as well as sustained improvements in general health and emotional well-being.","[{'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Katsogiannos', 'Affiliation': 'Departments of Medical Science, Clinical Diabetes and Metabolism Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Randell', 'Affiliation': 'School of Education, Health and Social Studies, Dalarna University, Falun, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Sundbom', 'Affiliation': 'Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rosenblad', 'Affiliation': 'Departments of Medical Science, Clinical Diabetes and Metabolism Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'Eriksson', 'Affiliation': 'Departments of Medical Science, Clinical Diabetes and Metabolism Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Janeth', 'Initials': 'J', 'LastName': 'Leksell', 'Affiliation': 'Departments of Medical Science, Clinical Diabetes and Metabolism Sciences, Uppsala University, Uppsala, Sweden.'}]",Diabetology & metabolic syndrome,['10.1186/s13098-020-00597-1']
2582,33062063,Prognostic role of a new index (multi inflammatory index) in patients with metastatic colorectal cancer: results from the randomized ITACa trial.,"Aims


We created a new index (Multi Inflammatory Index, MII) composed of an inflammatory index [neutrophil-to lymphocyte-ratio (NLR): MII-1; platelet-to-lymphocyte ratio (PLR): MII-2; or systemic immune-inflammation index (SII): MII-3] and C-reactive protein (CRP). Our aim was to evaluate the prognostic and/or predictive capacity of the MII in the randomized ITACa (Italian Trial in Advanced Colorectal Cancer) study on patients with metastatic colorectal cancer undergoing first-line chemotherapy.
Methods


Between November 2007 and March 2012, baseline NLR, PLR; SII and CRP were available for 131 patients, 66 receiving chemotherapy plus bevacizumab and 65 receiving chemotherapy alone.
Results


Patients with low (<25) MII-1 levels had a better outcome than those with high (⩾25) levels: median progression-free survival (PFS) was 12.4  versus  8.9 months [hazard ratio (HR) = 1.74, 95% confidence interval (CI) 1.21-2.51,  p  = 0.003] and median overall survival (OS) was 30.9 months  versus  15.0 months (HR = 2.05, 95% CI 1.40-3.02,  p  = 0.0002), respectively. Similar results were obtained for patients with low (<1424) MII-2 levels compared with those with high (⩾1424) levels: median PFS was 12.6  versus  8.9 months (HR = 1.95, 95% CI 1.35-2.82,  p  = 0.0004) and median OS was 32.4  versus  14.6 months, respectively (HR = 2.42, 95% CI 1.64-3.57,  p  < 0.0001). Patients with low (<6068) MII-3 levels had a longer median PFS and OS than those with high (⩾6068) levels: 12.6  versus  8.9 months (HR = 1.91, 95% CI 1.33-2.76,  p  = 0.005) and 30.9  versus 15.0 months (HR = 2.10, 95% CI 1.43-3.09,  p  = 0.0002), respectively. Following adjustment for clinical covariates, multivariate analysis confirmed all MII indexes as independent prognostic factors for predicting PFS and OS.
Conclusion


All MII indexes appear to be useful as prognostic markers.
Trial registration


ClinicalTrials.gov identifier: NCT01878422 (registration date: 07/06/2013) https://clinicaltrials.gov/ct2/show/NCT01878422.",2020,levels had a better outcome than those with high (⩾25) levels: median progression-free survival (PFS) was 12.4  versus  8.9 months [hazard ratio (HR) = ,"['patients with metastatic colorectal cancer', 'Patients with low (<25', 'patients with metastatic colorectal cancer undergoing first-line chemotherapy', 'Methods\n\n\nBetween November 2007 and March 2012']","['ITACa', 'chemotherapy plus bevacizumab', 'new index (multi inflammatory index']","['longer median PFS and OS', 'MII-1', 'inflammatory index [neutrophil-to lymphocyte-ratio (NLR', 'high (⩾25) levels: median progression-free survival (PFS', 'MII-1; platelet-to-lymphocyte ratio (PLR): MII-2; or systemic immune-inflammation index (SII): MII-3] and C-reactive protein (CRP', 'median OS', 'median overall survival (OS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.40103,levels had a better outcome than those with high (⩾25) levels: median progression-free survival (PFS) was 12.4  versus  8.9 months [hazard ratio (HR) = ,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Casadei Gardini', 'Affiliation': 'Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Scarpi', 'Affiliation': 'Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli 40, Meldola, Forlì, 47014, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Valgiusti', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Manlio', 'Initials': 'M', 'LastName': 'Monti', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ruscelli', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Matteucci', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Bartolini', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Vertogen', 'Affiliation': 'Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Pagan', 'Affiliation': 'Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Rovesti', 'Affiliation': 'Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Italy.'}, {'ForeName': 'Giovanni Luca', 'Initials': 'GL', 'LastName': 'Frassineti', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Passardi', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}]",Therapeutic advances in medical oncology,['10.1177/1758835920958363']
2583,33062081,The Effect of Adding Neuromuscular Electrical Stimulation with Endurance and Resistance Training on Exercise Capacity and Balance in Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial.,"This study investigated the effectiveness of adding neuromuscular electrical stimulation (NMES) to endurance training (ET) and resistance training (RT) on exercise tolerance and balance in COPD patients. 42 patients were assigned randomly to the ET + RT + NMES group ( n  = 22) or ET + RT group ( n  = 20). Two training programs were performed including 72 sessions. The center of pressure (CoP) displacement in the mediolateral direction (CoPML), in the anteroposterior direction (CoPAP), and the center of pressure velocity (CoPV) were recorded using a stabilometric platform with eyes open (EO) and eyes closed (EC). Time up and go and Berg Balance Scale tests, 6-minute walking test (6MWT), and the maximal voluntary contraction (MVC) were measured before and after the intervention. The walking distance, the dyspnea, and the heart rate were improved after the training period ( p  < 0.001) for both groups ( p  < 0.05). The ET + RT + NMES group showed better improvement than the ET + RT group in terms of 6MWD. CoP ML , CoP AP , and CoP V  were significantly ( p  < 0.001;  p  < 0.05;  p  < 0.001, respectively) more improved in EO and EC conditions in the ET + RT + NMES group than the ET + RT group. BBS, TUG, and MVC values improved in both groups after the training ( p  < 0.001). The performances in TUG and MVC tests were significantly greater in the ET + RT + NMES group than those in the ET + RT group ( p  < 0.01;  p  < 0.001, respectively). Combining NMES, RT, and ET improves balance in patients with COPD.",2020,The ET + RT + NMES group showed better improvement than the ET + RT group in terms of 6MWD.,"['COPD patients', '42 patients', 'patients with COPD', 'Patients with Chronic Obstructive Pulmonary Disease']","['Neuromuscular Electrical Stimulation with Endurance and Resistance Training', 'neuromuscular electrical stimulation (NMES) to endurance training (ET) and resistance training (RT', 'NMES, RT, and ET', 'ET\u2009+\u2009RT', 'stabilometric platform with eyes open (EO) and eyes closed (EC', 'ET\u2009+\u2009RT\u2009+\u2009NMES']","['Exercise Capacity and Balance', 'exercise tolerance and balance', 'BBS, TUG, and MVC values', 'performances in TUG and MVC tests', 'Time up and go and Berg Balance Scale tests, 6-minute walking test (6MWT), and the maximal voluntary contraction (MVC', 'EO and EC conditions', 'walking distance, the dyspnea, and the heart rate', 'CoP ML , CoP AP , and CoP V']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}]",42.0,0.0181182,The ET + RT + NMES group showed better improvement than the ET + RT group in terms of 6MWD.,"[{'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Acheche', 'Affiliation': ""Laboratoire de Recherche Physiologie de l'Exercice et Physiopathologie: de l'intégré au moléculaire « Biologie, Médecine et Santé » (LR19ES09), Faculté de Médecine de Sousse, Sousse 4002, Tunisia.""}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Mekki', 'Affiliation': ""Laboratoire de Recherche Physiologie de l'Exercice et Physiopathologie: de l'intégré au moléculaire « Biologie, Médecine et Santé » (LR19ES09), Faculté de Médecine de Sousse, Sousse 4002, Tunisia.""}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Paillard', 'Affiliation': ""Movement, Balance, Performance and Health Laboratory (EA 4445), University of Pau and des Pays de l'Adour, Pau 64012, France.""}, {'ForeName': 'Zouhair', 'Initials': 'Z', 'LastName': 'Tabka', 'Affiliation': ""Laboratoire de Recherche Physiologie de l'Exercice et Physiopathologie: de l'intégré au moléculaire « Biologie, Médecine et Santé » (LR19ES09), Faculté de Médecine de Sousse, Sousse 4002, Tunisia.""}, {'ForeName': 'Yassine', 'Initials': 'Y', 'LastName': 'Trabelsi', 'Affiliation': ""Laboratoire de Recherche Physiologie de l'Exercice et Physiopathologie: de l'intégré au moléculaire « Biologie, Médecine et Santé » (LR19ES09), Faculté de Médecine de Sousse, Sousse 4002, Tunisia.""}]",Canadian respiratory journal,['10.1155/2020/9826084']
2584,33062209,Patterns of change in physical functioning and posttraumatic stress disorder with cognitive processing therapy in a randomized controlled implementation trial.,"Background : Physical health concerns (e.g. chronic pain, fatigue) are common among clients with posttraumatic stress disorder (PTSD). Prior research has indicated that clients report improved physical functioning and fewer physical health symptoms after receiving Cognitive Processing Therapy (CPT) for PTSD. However, less is known about the impact of physical functioning on the clients' PTSD symptom improvement in CPT.  Objective : The current study examined the patterns of change of and between physical functioning and PTSD symptoms over the course of CPT among a diverse military, veteran, and community sample.  Method : We collected clients' ( N  = 188) physical functioning and PTSD symptom severity prior to and during CPT using the 12-Item Short Form Health Survey and the PTSD Checklist. We used multilevel modelling to 1) evaluate the impact of baseline physical functioning on the PTSD symptom trajectory, 2) examine the trajectory of physical functioning, and 3) assess the dynamics between physical functioning and PTSD symptoms over the course of CPT.  Results : Our multilevel analyses indicated that 1) physical functioning significantly improved for those with low levels of functioning prior to treatment, 2) poorer baseline physical functioning predicted slower improvements in PTSD symptoms, and 3) poorer physical functioning in one session predicted less PTSD symptom improvement by the next session.  Conclusions : Our findings demonstrate that while physical functioning can interfere with PTSD symptom improvement, physical functioning can also improve over the course of CPT. In light of the interconnected nature of physical health and PTSD symptoms, clinicians may need to attend to lower levels of physical functioning when providing CPT or other trauma-focused therapies. Future research to determine whether specific treatment adaptations may benefit such clients is needed.",2020,Prior research has indicated that clients report improved physical functioning and fewer physical health symptoms after receiving Cognitive Processing Therapy (CPT) for PTSD.,"['clients with posttraumatic stress disorder (PTSD', ""collected clients' ( N  =\xa0188) physical functioning and PTSD symptom severity prior to and during CPT using the 12-Item Short Form Health Survey and the PTSD Checklist""]","['cognitive processing therapy', 'Cognitive Processing Therapy (CPT', ' ']","['PTSD symptom improvement', 'physical functioning and fewer physical health symptoms', 'PTSD symptoms, and 3) poorer physical functioning']","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]","[{'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",188.0,0.0150509,Prior research has indicated that clients report improved physical functioning and fewer physical health symptoms after receiving Cognitive Processing Therapy (CPT) for PTSD.,"[{'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'National Center for PTSD, VA Palo Alto Healthcare System, Menlo Park, CA, USA.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'National Center for PTSD, VA Palo Alto Healthcare System, Menlo Park, CA, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Suvak', 'Affiliation': 'Department of Psychology, Suffolk University, Boston, MA, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Shields', 'Affiliation': 'Royal Canadian Mounted Police, Westmount, QC, Canada.'}, {'ForeName': 'Jeanine E M', 'Initials': 'JEM', 'LastName': 'Lane', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, ON, Canada.'}, {'ForeName': 'Candice M', 'Initials': 'CM', 'LastName': 'Monson', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, ON, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Wiltsey-Stirman', 'Affiliation': 'National Center for PTSD, VA Palo Alto Healthcare System, Menlo Park, CA, USA.'}]",European journal of psychotraumatology,['10.1080/20008198.2020.1801166']
2585,33062311,Effect of Adding Losartan to Bevacizumab for Treating Diabetic Macular Edema.,"Introduction


Diabetic retinopathy is the most common cause of visual loss and blindness in the age group of 20 to 64 years. This study aimed to evaluate the efficacy of oral Losartan adjuvant therapy in combination with intravitreal injection of Bevacizumab in the treatment of diabetic macular edema.
Methods


In this randomized clinical trial, 61 eyes of 47 patients with normal blood pressure and diabetic macular edema and nonproliferative diabetic retinopathy were studied. Patients were randomly divided into Losartan ( n  = 33) and control ( n  = 28) groups. All patients received 3-6 intravitreal injections of Bevacizumab over 6 months. General examination including blood pressure and glycosylated hemoglobin measurements were performed in all patients. Complete ophthalmologic examination and macular OCT were performed at the first, third, and sixth months of treatment in all patients.
Results


The mean age of the patients studied was 57.1 ± 7.4 years and 37.7% of the patients were male. There was no significant difference between the two groups in terms of initial visual acuity, central macular thickness, and frequency of injections. There was no significant difference in visual acuity and central macular thickness between the two groups at the first, third, and sixth months of treatment. Age, frequency of injection, and initial macular thickness less than 450 microns were effective in patients' final visual acuity.
Conclusion


Short-term adjuvant treatment with Losartan in patients with diabetic macular edema and nonproliferative diabetic retinopathy has no greater effect than the standard treatment.",2020,"There was no significant difference in visual acuity and central macular thickness between the two groups at the first, third, and sixth months of treatment.","['Diabetic Macular Edema', '61 eyes of 47 patients with normal blood pressure and diabetic macular edema and nonproliferative diabetic retinopathy were studied', 'mean age of the patients studied was 57.1\u2009±\u20097.4 years and 37.7% of the patients were male', 'diabetic macular edema', 'patients with diabetic macular edema and nonproliferative diabetic retinopathy']","['Losartan', 'Losartan to Bevacizumab', 'oral Losartan adjuvant therapy', 'Bevacizumab']","['blood pressure and glycosylated hemoglobin measurements', 'initial visual acuity, central macular thickness, and frequency of injections', 'visual acuity and central macular thickness', 'Complete ophthalmologic examination and macular OCT']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0004606', 'cui_str': 'Nonproliferative diabetic retinopathy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]",47.0,0.0183979,"There was no significant difference in visual acuity and central macular thickness between the two groups at the first, third, and sixth months of treatment.","[{'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Ghassemi', 'Affiliation': 'Department of Ophthalmology, Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abdulrahim', 'Initials': 'A', 'LastName': 'Amini', 'Affiliation': 'Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Yasemi', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Nabavi', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadkarim', 'Initials': 'M', 'LastName': 'Johari', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of ophthalmology,['10.1155/2020/4528491']
2586,33062315,First Experience in Small Incision Lenticule Extraction with the Femto LDV Z8 and Lenticule Evaluation Using Scanning Electron Microscopy.,"Purpose


To evaluate the specifications and technique properties of the new Femto LDV Z8 in creating intrastromal refractive lenticules during small incision lenticule extraction (SMILE).
Methods


Six enucleated porcine eyeballs were equally divided into two groups (Femto LDV Z8 or VisuMax) and were randomly assigned to three experienced refractive surgeons who performed SMILE on each group. Five intraoperative time parameters and surgeons' satisfaction on the surgical procedure were compared between two groups. Postoperatively, the roughness of the lenticule surfaces and the irregularity of edges were observed by scanning electron microscopy (SEM) and were also compared between the two groups.
Results


Longer time on suction peak pressure, total laser application, and total surgery were spent in the Femto LDV Z8 group as compared with the VisuMax group. The Femto LDV Z8 group applied OCT scanning and offsetting before performing the laser procedure, which expended more time for these crucial steps. The widest range of surgeons' satisfaction scores was found in the step of lenticule interface identification of the Femto LDV Z8 group. The roughness scores of the anterior and posterior lenticule surfaces were statistically less in the Femto LDV Z8 group than in the VisuMax group (anterior, ×180,  p =0.039; anterior, ×250,  p =0.337; posterior, ×180,  p =0.006; and posterior, ×250,  p =0.007).
Conclusions


Femto LDV Z8 showed promising performances as a novel SMILE equipment for the correction of myopia. It has special and unique features for SMILE procedures, which need more learning and researching processes. With its low-energy high-frequency nJ-level laser system, the Femto LDV Z8 provided smoother lenticule surface than VisuMax.",2020,"The roughness scores of the anterior and posterior lenticule surfaces were statistically less in the Femto LDV Z8 group than in the VisuMax group (anterior, ×180,  p =0.039; anterior, ×250,  p =0.337; posterior, ×180,  p =0.006; and posterior, ×250,  p =0.007).
",['Methods\n\n\nSix enucleated porcine eyeballs'],[],"[""widest range of surgeons' satisfaction scores"", 'Longer time on suction peak pressure, total laser application, and total surgery', 'roughness of the lenticule surfaces and the irregularity of edges', 'roughness scores of the anterior and posterior lenticule surfaces']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]",[],"[{'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]",6.0,0.0204279,"The roughness scores of the anterior and posterior lenticule surfaces were statistically less in the Femto LDV Z8 group than in the VisuMax group (anterior, ×180,  p =0.039; anterior, ×250,  p =0.337; posterior, ×180,  p =0.006; and posterior, ×250,  p =0.007).
","[{'ForeName': 'Mengmeng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Hebei Ophthalmology Key Lab, Hebei Eye Hospital, Xingtai 054000, Hebei Province, China.'}, {'ForeName': 'Fengju', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Ohthalmology and Visual Sciences Key Lab, Beijing 100730, China.'}, {'ForeName': 'Christine Carole', 'Initials': 'CC', 'LastName': 'Copruz', 'Affiliation': 'Ifugao State University Eye Center, Alfonso Lista, Ifugao 3608, Philippines.'}, {'ForeName': 'Longhui', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': 'Hebei Ophthalmology Key Lab, Hebei Eye Hospital, Xingtai 054000, Hebei Province, China.'}]",Journal of ophthalmology,['10.1155/2020/6751826']
2587,33062443,A strength-oriented exercise session required more recovery time than a power-oriented exercise session with equal work.,"The present randomized cross-over controlled study aimed to compare the rate of recovery from a strength-oriented exercise session vs. a power-oriented session with equal work. Sixteen strength-trained individuals conducted one strength-oriented session (five repetitions maximum (RM)) and one power-oriented session (50% of 5RM) in randomized order. Squat jump (SJ), countermovement jump (CMJ), 20-m sprint, and squat and bench press peak power and estimated 1RMs were combined with measures of rate of perceived exertion (RPE) and perceived recovery status (PRS), before, immediately after and 24 and 48 h after exercise. Both sessions induced trivial to moderate performance decrements in all variables. Small reductions in CMJ height were observed immediately after both the strength-oriented session (7 ± 6%) and power-oriented session (5 ± 5%). Between 24 and 48 h after both sessions CMJ and SJ heights and 20 m sprint were back to baseline. However, in contrast to the power-oriented session, recovery was not complete 48 h after the strength-oriented session, as indicated by greater impairments in CMJ eccentric and concentric peak forces, SJ rate of force development (RFD) and squat peak power. In agreement with the objective performance measurements, RPE and PRS ratings demonstrated that the strength-oriented session was experienced more strenuous than the power-oriented session. However, these subjective measurements agreed poorly with performance measurements at the individual level. In conclusion, we observed a larger degree of neuromuscular impairment and longer recovery times after a strength-oriented session than after a power-oriented session with equal total work, measured by both objective and subjective assessments. Nonetheless, most differences were small or trivial after either session. It appears necessary to combine several tests and within-test analyses (e.g., CMJ height, power and force) to reveal such differences. Objective and subjective assessments of fatigue and recovery cannot be used interchangeably; rather they should be combined to give a meaningful status for an individual in the days after a resistance exercise session.",2020,"However, in contrast to the power-oriented session, recovery was not complete 48 h after the strength-oriented session, as indicated by greater impairments in CMJ eccentric and concentric peak forces, SJ rate of force development (RFD) and squat peak power.",['Sixteen strength-trained individuals conducted one'],"['strength-oriented session (five repetitions maximum (RM)) and one power-oriented session (50% of 5RM', 'strength-oriented exercise session', 'strength-oriented exercise session vs. a power-oriented session with equal work']","['recovery time', 'CMJ eccentric and concentric peak forces, SJ rate of force development (RFD) and squat peak power', 'CMJ height', 'Squat jump (SJ), countermovement jump (CMJ), 20-m sprint, and squat and bench press peak power and estimated 1RMs were combined with measures of rate of perceived exertion (RPE) and perceived recovery status (PRS', 'objective performance measurements, RPE and PRS ratings']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",,0.0240027,"However, in contrast to the power-oriented session, recovery was not complete 48 h after the strength-oriented session, as indicated by greater impairments in CMJ eccentric and concentric peak forces, SJ rate of force development (RFD) and squat peak power.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Helland', 'Affiliation': 'Norwegian Olympic and Paralympic Committee and Confederation of Sports, Oslo, Norway.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Midttun', 'Affiliation': 'Norwegian Olympic and Paralympic Committee and Confederation of Sports, Oslo, Norway.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Saeland', 'Affiliation': 'Norwegian Olympic and Paralympic Committee and Confederation of Sports, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Haugvad', 'Affiliation': 'Norwegian Olympic and Paralympic Committee and Confederation of Sports, Oslo, Norway.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Schäfer Olstad', 'Affiliation': 'Polar Electro Oy, Kempele, Finland.'}, {'ForeName': 'Paul Andre', 'Initials': 'PA', 'LastName': 'Solberg', 'Affiliation': 'Norwegian Olympic and Paralympic Committee and Confederation of Sports, Oslo, Norway.'}, {'ForeName': 'Gøran', 'Initials': 'G', 'LastName': 'Paulsen', 'Affiliation': 'Norwegian Olympic and Paralympic Committee and Confederation of Sports, Oslo, Norway.'}]",PeerJ,['10.7717/peerj.10044']
2588,33062627,Pharmacodynamic evaluation of YH4808 for  Helicobacter pylori  eradication in healthy subjects.,"YH4808 is a novel selective potassium-competitive acid blocker demonstrated to be safe and to have inhibitory effects against gastric acid secretion in previous studies. A randomized, open-label, multiple-dose, 3-treatment, 1-period, parallel design study was conducted to compare the  Helicobacter pylori  eradication rates and acid suppression capacities of three regimens in 60 healthy subjects with  H. pylori -positive, and the potential of YH4808 to replace proton-pump inhibitors (PPIs) in standard regimens for  H. pylori  eradication. Group 1 received YH4808, amoxicillin, and clarithromycin as a novel triple regimen, while Group 2 received YH4808 and amoxicillin only, and Group 3 received esomeprazole, amoxicillin, and clarithromycin, as the standard triple regimen.  H. pylori  eradication rates were 85.0% for Group 1, 25.0% for Group 2, and 83.3% for Group 3. Relative response rate between Group 1 and 3 was 1.02 (0.50-2.07; 95% CI, χ 2  test  p  = 0.8881). Furthermore, the novel triple regimen, YH4808, amoxicillin, and clarithromycin, stably inhibited acid secretion and maintained a gastric pH greater than 4 or 5 for 24 hours, which was comparable to the pH range in the standard triple regimen. However, the onset times of the YH4808 regimens were earlier than that for the regimens using esomeprazole. There were no differences in the incidences or severity of adverse events among the three groups. Overall, the novel triple regimen was safe and well-tolerated. YH4808 could replace PPIs in standard triple regimens used for  H. pylori  eradication.
Trial Registration


ClinicalTrials.gov Identifier: NCT01921647.",2020,"H. pylori  eradication rates were 85.0% for Group 1, 25.0% for Group 2, and 83.3% for Group 3.","['60 healthy subjects with  H. pylori -positive, and the potential of YH4808 to replace proton-pump inhibitors (PPIs) in standard regimens for  H. pylori  eradication', 'healthy subjects']","['esomeprazole', 'YH4808 and amoxicillin', 'esomeprazole, amoxicillin, and clarithromycin', 'YH4808, amoxicillin, and clarithromycin', 'amoxicillin, and clarithromycin']","['Relative response rate', 'safe and well-tolerated', 'incidences or severity of adverse events', 'H. pylori  eradication rates']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4547142', 'cui_str': 'YH4808'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C4547142', 'cui_str': 'YH4808'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",60.0,0.0227467,"H. pylori  eradication rates were 85.0% for Group 1, 25.0% for Group 2, and 83.3% for Group 3.","[{'ForeName': 'Hyeonsoo', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Choon Ok', 'Initials': 'CO', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Mikyung', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Clinical Development Department, R&D Division, Yuhan Corporation, Seoul 03722, Korea.'}, {'ForeName': 'Yeji', 'Initials': 'Y', 'LastName': 'Lim', 'Affiliation': 'Clinical Development Department, R&D Division, Yuhan Corporation, Seoul 03722, Korea.'}, {'ForeName': 'Woo Yul', 'Initials': 'WY', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Sukyong', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'Department of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Min Soo', 'Initials': 'MS', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea.'}]",Translational and clinical pharmacology,['10.12793/tcp.2020.28.e16']
2589,33062754,Improvement of osteoporosis-related behaviors in female students based on trans theoretical model.,"BACKGROUND


Osteoporosis is one of the major problems associated with aging and is more common among women than men. This study was designed to modify osteoporosis-related behaviors in female students based on the transtheoretical model (TTM).
MATERIALS AND METHODS


This quasi-experimental study was conducted on female secondary school students. The sample size was determined 100 by using Altman's nomogram, including 50 cases and 50 controls. Participants were completed the Demographic Information and Osteoporosis-Related Behavior Questionnaire based on TTM. Evaluation of the data showed that each participant was at what stage of change in physical activity and preventive dietary behavior of osteoporosis. The content of the training package was designed, and for the intervention group, 2-h training sessions were held weekly by the instructor in accordance with the stage of change for 2 months, and the booklet was provided with the appropriate contents of the stage of change. Three months after the completion of training, the questionnaires were completed by intervention and control groups. Statistical analysis was performed using SPSS 23 software.
RESULTS


Concerning the stages of change in physical activity and nutrition, a significant difference was before and after the intervention in the intervention group ( P  < 0.001), while no significant difference was observed in the control group. After the intervention, there was a significant difference in the self-efficacy and some subconstruct of processes of change, but there wasnot a significant difference in the decisional balance.
CONCLUSION


Educational intervention based on TTM has been successful in achieving the goal of modifying osteoporosis-related behaviors in female students. The results of this study can be used by health planners to plan and implement health promotion interventions that will undoubtedly help reduce the burden of disease.",2020,"After the intervention, there was a significant difference in the self-efficacy and some subconstruct of processes of change, but there wasnot a significant difference in the decisional balance.
","['female students based on the transtheoretical model (TTM', 'women than men', 'female secondary school students', 'female students']",['Educational intervention based on TTM'],"['Demographic Information and Osteoporosis-Related Behavior Questionnaire based on TTM', 'decisional balance', 'self-efficacy', 'physical activity and preventive dietary behavior of osteoporosis']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",,0.025119,"After the intervention, there was a significant difference in the self-efficacy and some subconstruct of processes of change, but there wasnot a significant difference in the decisional balance.
","[{'ForeName': 'Vahid Kohpeima', 'Initials': 'VK', 'LastName': 'Jahromi', 'Affiliation': 'Research Center for Social Determinants of Health, Jahrom University of Medical Sciences, Jahrom, Iran.'}, {'ForeName': 'Sepide Bahlouli', 'Initials': 'SB', 'LastName': 'Ghashghaei', 'Affiliation': 'Research Center for Social Determinants of Health, Jahrom University of Medical Sciences, Jahrom, Iran.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Sharifi', 'Affiliation': 'Research Center for Social Determinants of Health, Jahrom University of Medical Sciences, Jahrom, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_213_20']
2590,33062765,Preliminary Results From a US Clinical Trial of a Novel Synthetic Polymer Meniscal Implant.,"Background


At least 760,000 outpatient meniscectomies are performed in the United States each year, making this the most common musculoskeletal procedure. However, meniscal resection can alter the joint biomechanics and overload the articular cartilage, which may contribute to degenerative changes and the need for knee replacement. Avoiding or delaying knee replacement is particularly important in younger or more active patients. Synthetic meniscal implants have been developed in an attempt to restore the natural joint biomechanics, alleviate pain and disability, and potentially minimize degenerative changes in patients who require meniscectomy.
Purpose


To evaluate the preliminary results from 2 ongoing trials that are evaluating the safety and effectiveness of a synthetic polymer meniscal implant (NUsurface; Active Implants, LLC).
Study Design


Cohort study; Level of evidence, 2.
Methods


This was a preliminary analysis of the first 100 patients enrolled across 2 studies for 12 months: a single-arm, intervention-only study and a randomized controlled trial comparing the investigational meniscal implant with nonsurgical therapy. There were 65 patients in the implant group (30 randomized) and 35 in the control group. Outcomes included Knee injury and Osteoarthritis Outcome Score (KOOS) and adverse events (AEs) collected at baseline and follow-up visits of 6 weeks, 6 months, and 12 months.
Results


No statistically significant differences were found in baseline characteristics between the implant and control groups. At 12 months, follow-up KOOS data were available for 87% of the 100 included patients. Significantly greater improvements from baseline were observed in the implant group compared with controls in all KOOS subcomponents, except for symptoms (119%-177% greater improvement at 12 months). AEs were reported at similar rates between the 2 groups, with 12 AEs among 11 patients in the implant group (16.9%) versus 5 AEs among 5 patients (14.3%) in the control group ( P  = .99).
Conclusion


These preliminary results suggest significant improvements in pain and function scores with the implant over nonsurgical therapy and a similar adverse event rate.",2020,"Significantly greater improvements from baseline were observed in the implant group compared with controls in all KOOS subcomponents, except for symptoms (119%-177% greater improvement at 12 months).","['younger or more active patients', 'patients who require meniscectomy', '100 patients enrolled across 2 studies for 12 months: a single-arm, intervention-only study', '65 patients in the implant group (30 randomized) and 35 in the control group']","['investigational meniscal implant with nonsurgical therapy', 'synthetic polymer meniscal implant (NUsurface; Active Implants, LLC']","['Knee injury and Osteoarthritis Outcome Score (KOOS) and adverse events (AEs', 'pain and function scores', 'safety and effectiveness']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0187901', 'cui_str': 'Chondrectomy of semilunar cartilage of knee'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0440257', 'cui_str': 'Synthetic polymer'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",100.0,0.154458,"Significantly greater improvements from baseline were observed in the implant group compared with controls in all KOOS subcomponents, except for symptoms (119%-177% greater improvement at 12 months).","[{'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'McKeon', 'Affiliation': 'Boston Sports & Shoulder Center, Waltham, Massachusetts, USA.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Zaslav', 'Affiliation': 'Ortho Virginia, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Alfred', 'Affiliation': 'The Bone & Joint Center and Albany Medical College, Albany, New York, USA.'}, {'ForeName': 'R Maxwell', 'Initials': 'RM', 'LastName': 'Alley', 'Affiliation': 'The Bone & Joint Center and Albany Medical College, Albany, New York, USA.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Edelson', 'Affiliation': 'Sports Medicine Oregon, Tigard, Oregon, USA.'}, {'ForeName': 'Wayne K', 'Initials': 'WK', 'LastName': 'Gersoff', 'Affiliation': 'Advanced Orthopedic and Sports Medicine Specialists, Denver, Colorado, USA.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Greenleaf', 'Affiliation': 'Sports Medicine Oregon, Tigard, Oregon, USA.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Kaeding', 'Affiliation': 'Sports Medicine Institute and Department of Orthopaedics, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.'}]",Orthopaedic journal of sports medicine,['10.1177/2325967120952414']
2591,33062830,Developing Adult Sepsis Protocol to Reduce the Time to Initial Antibiotic Dose and Improve Outcomes among Patients with Cancer in Emergency Department.,"Objective


Sepsis is a common cause of noncancer-related deaths among oncology patients. Delay in the initiation of efficient antimicrobial therapy will decrease the survival rate. This study aims to develop a sepsis protocol for adult oncology patients to decrease the time needed to receive the initial dose of antibiotic in an emergency department (ED), improve the early recognition of sepsis, and decrease the in-hospital mortality rate due to sepsis.
Methods


A quasi-experimental research design was used. A total of 168 participants were assigned into pre- and post-intervention groups ( n  = 85) and ( n  = 83), respectively. The quick Sequential Organ Failure Assessment screening tool was used to screen patients in the triage room.
Results


There was a significant difference in the proportions of receiving the initial antibiotic dose whether ≤1 h or >1 h between pre- and post-intervention groups. The results also showed that 89.4% of the postintervention group received their initial antibiotic dose in <1 h compared with 10.8% of the preintervention group. The median time needed for administering the initial antibiotic dose was decreased from 95 min to 45 min. The results of the changes in mortality rates are promising as it decreased 11.7% after applying the adult sepsis protocol.
Conclusions


Applying an adult sepsis protocol in the ED significantly decreased the time needed to initiate antibiotic treatment. It is recommended to utilize a multidisciplinary and systematic approach in screening and treating sepsis.",2020,"The results of the changes in mortality rates are promising as it decreased 11.7% after applying the adult sepsis protocol.
","['adult oncology patients', 'Patients with Cancer in Emergency Department', 'screen patients in the triage room', '168 participants']",[],"['median time needed for administering the initial antibiotic dose', 'mortality rates', 'initial antibiotic dose', 'time needed to initiate antibiotic treatment', 'proportions of receiving the initial antibiotic dose', 'survival rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C4319556', 'cui_str': '168'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",168.0,0.0781337,"The results of the changes in mortality rates are promising as it decreased 11.7% after applying the adult sepsis protocol.
","[{'ForeName': 'Mustafa Z', 'Initials': 'MZ', 'LastName': 'Bader', 'Affiliation': 'Department of Nursing, King Hussein Cancer Center, Amman, Jordan.'}, {'ForeName': 'Abdullah T', 'Initials': 'AT', 'LastName': 'Obaid', 'Affiliation': 'Department of Nursing, King Hussein Cancer Center, Amman, Jordan.'}, {'ForeName': 'Hisham M', 'Initials': 'HM', 'LastName': 'Al-Khateb', 'Affiliation': 'Department of Nursing, King Hussein Cancer Center, Amman, Jordan.'}, {'ForeName': 'Yazeed T', 'Initials': 'YT', 'LastName': 'Eldos', 'Affiliation': 'Weill Cornell Medicine, Qatar.'}, {'ForeName': 'Moath M', 'Initials': 'MM', 'LastName': 'Elaya', 'Affiliation': 'Department of Nursing, King Hussein Cancer Center, Amman, Jordan.'}]",Asia-Pacific journal of oncology nursing,['10.4103/apjon.apjon_32_20']
2592,33062835,Effectiveness of Education Program on Nursing Knowledge and Attitude toward Pain Management.,"Objective


Nurses have an integral role in pain assessment and management. Adequate knowledge and positive attitudes toward pain management are essential to provide high-quality nursing care for cancer pain. The purposes of this study are to evaluate nurses' knowledge and attitude toward cancer-related pain and to assess the effectiveness of a pain management education program on nurses' knowledge and attitude toward pain.
Methods


A quantitative, experimental design was used.
Results


The total number of participants who were surveyed at three measurement points was 131, with a completion rate of 87.3%. Findings revealed that the score of knowledge and attitude toward cancer-related pain ranged from 14 to 35, with a mean of 23.6 (standard deviation [SD] = 4.38). The mean scores of the intervention group and the control group at two measurement points regarding knowledge and attitude toward cancer-related pain were 32.7 (SD = 2.8) and 32.8 (SD = 4.3) and 23 (SD = 5.5) and 22.2 (SD = 3.8), respectively. There were significant differences at three measurement points among the intervention group ( F  = 114.3,  P  < 0.0005). There were no differences in the three measurement points among the control group ( F  = 3.4,  P  = 0.055).
Conclusions


Nurses have essential roles in cancer pain. A pain management education program can improve nurses' knowledge and attitude toward cancer-related pain.",2020,"There were no differences in the three measurement points among the control group ( F  = 3.4,  P  = 0.055).
",[],"['Education Program', 'pain management education program']","['knowledge and attitude toward cancer-related pain', 'score of knowledge and attitude toward cancer-related pain', ""nurses' knowledge and attitude toward cancer-related pain"", 'mean scores', 'Nursing Knowledge and Attitude toward Pain Management']",[],"[{'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C1276796', 'cui_str': 'Pain management education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",,0.0252336,"There were no differences in the three measurement points among the control group ( F  = 3.4,  P  = 0.055).
","[{'ForeName': 'Aqel', 'Initials': 'A', 'LastName': 'El-Aqoul', 'Affiliation': 'Department of Nursing, King Hussein Cancer Center, Amman, Jordan.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Obaid', 'Affiliation': 'Department of Nursing, King Hussein Cancer Center, Amman, Jordan.'}, {'ForeName': 'Ihsan', 'Initials': 'I', 'LastName': 'Jarrah', 'Affiliation': 'Department of Nursing, King Hussein Cancer Center, Amman, Jordan.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Al-Rawashdeh', 'Affiliation': 'Department of Nursing, King Hussein Cancer Center, Amman, Jordan.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Al Hroub', 'Affiliation': 'Department of Nursing, King Hussein Cancer Center, Amman, Jordan.'}]",Asia-Pacific journal of oncology nursing,['10.4103/apjon.apjon_17_20']
2593,33062871,Improper Communication Makes for Squat: A Qualitative Study of the Health-Care Processes Experienced By Older Adults in a Clinical Trial for Back Pain.,"Background


The study focused on perceptions of older adults toward the healthcare processes they experienced during a clinical trial for back pain that involved family medicine residents and licensed chiropractors.
Methods


Individual semi-structured interviews were conducted with 115 older adults after a 12-week, 3-arm, randomized controlled trial. Two researchers conducted thematic analysis with inductive coding using qualitative software to identify participants' salient experiences of the doctor-patient relationship, healthcare process, and collaboration between study providers. Investigators categorized thematic codes within an existing framework of clinical excellence in primary care.
Results


Participants emphasized provider communication and interpersonal relationships, professionalism and passion for patient care, clinical and diagnostic acumen, and skillful negotiation of the health-care system. Older adults also described the importance of interdisciplinary collaboration and their preferences for receiving hands-on treatments for musculoskeletal conditions.
Conclusion


These older adults valued doctors who communicated clearly and spent time listening to their concerns. Many participants appreciated clinicians who supported an active role for patients in their health-care and who provided touch-based care for musculoskeletal conditions.",2020,"Two researchers conducted thematic analysis with inductive coding using qualitative software to identify participants' salient experiences of the doctor-patient relationship, healthcare process, and collaboration between study providers.","['Older adults', 'Health-Care Processes Experienced By Older Adults in a Clinical Trial for Back Pain', 'older adults toward the healthcare processes they experienced during a clinical trial for back pain that involved family medicine residents and licensed chiropractors', '115 older adults', 'Squat']",[],"['provider communication and interpersonal relationships, professionalism and passion for patient care, clinical and diagnostic acumen, and skillful negotiation of the health-care system']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0334952', 'cui_str': 'Chiropractor'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]",[],"[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0815219', 'cui_str': 'Professionalism'}, {'cui': 'C0939808', 'cui_str': 'Passion flower extract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]",2.0,0.0515191,"Two researchers conducted thematic analysis with inductive coding using qualitative software to identify participants' salient experiences of the doctor-patient relationship, healthcare process, and collaboration between study providers.","[{'ForeName': 'Breanne M', 'Initials': 'BM', 'LastName': 'Wells', 'Affiliation': 'Technique Department, Palmer College of Chiropractic, Davenport, IA, USA.'}, {'ForeName': 'Stacie A', 'Initials': 'SA', 'LastName': 'Salsbury', 'Affiliation': 'Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA, USA.'}, {'ForeName': 'Lia M', 'Initials': 'LM', 'LastName': 'Nightingale', 'Affiliation': 'Life Sciences Department, Palmer College of Chiropractic, Davenport, IA, USA.'}, {'ForeName': 'Dustin C', 'Initials': 'DC', 'LastName': 'Derby', 'Affiliation': 'College Administration, Palmer College of Chiropractic, Davenport, IA, USA.'}, {'ForeName': 'Dana J', 'Initials': 'DJ', 'LastName': 'Lawrence', 'Affiliation': 'Parker Research Institute, Parker University, Dallas, TX, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Goertz', 'Affiliation': 'Spine Institute for Quality, Oskaloosa, IA, USA.'}]",Journal of patient experience,['10.1177/2374373519860347']
2594,33048875,Impact of a community-wide combination HIV prevention intervention on knowledge of HIV status among adolescents.,"OBJECTIVE


To determine the impact of a community-wide combination HIV-prevention package (PopART Intervention) that includes universal testing and treatment (UTT) on knowledge of HIV-status, among adolescents aged 15-19 years.
DESIGN


The HPTN 071 (PopART) for Youth (P-ART-Y) study was nested within HPTN 071 (PopART), a 3-arm, cluster-randomized trial conducted from 2013 through 2018 in 21 communities in Zambia and South Africa. Communities were randomly assigned to Arm A (combination prevention intervention with universal ART), Arm B (prevention intervention with ART provided according to local guidelines), or Arm C (standard-of-care).
METHODS


Knowledge of HIV-status was measured using data collected during the third round of the PopART intervention in arms A and B (October 2016 to December 2017) and by conducting a cross-sectional survey (August to November 2017) in arm C communities to provide comparative data. The survey was conducted among ∼ 200 randomly selected adolescents in each community. We used linear regression of the 21 community-level values to make comparisons among trial arms.
RESULTS


Knowledge of HIV-status was 78.2% (23,544/30,089) in Arm A and 76.0% (24,417/32,148) in Arm B communities, compared to 32.9% (698/2,120) in Arm C communities. Knowledge of HIV-status varied by country, triplet, sex, and age. The adjusted mean difference was 42.3% between arm A with arm C, 95% CI 28.1-56.6, p < 0.001 and 40.4% between arm B with arm C, 95% CI 24.6-56.2, p < 0.001).
CONCLUSION


Implementation of a community-wide combination HIV-prevention package that includes UTT substantially enhanced knowledge of HIV-status among adolescents.",2020,"The adjusted mean difference was 42.3% between arm A with arm C, 95% CI 28.1-56.6, p < 0.001 and 40.4% between arm B with arm C, 95% CI 24.6-56.2, p < 0.001).
","['adolescents aged 15-19 years', 'The HPTN 071 (PopART) for Youth (P-ART-Y) study was nested within HPTN 071 (PopART), a 3-arm, cluster-randomized trial conducted from 2013 through 2018 in 21 communities in Zambia and South Africa', 'adolescents', '200 randomly selected adolescents in each community']","['PopART intervention', 'community-wide combination HIV-prevention package (PopART Intervention', 'community-wide combination HIV prevention intervention', 'Arm A (combination prevention intervention with universal ART), Arm B (prevention intervention with ART provided according to local guidelines), or Arm C (standard-of-care', 'universal testing and treatment (UTT']",['knowledge of HIV status'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}]",200.0,0.0674336,"The adjusted mean difference was 42.3% between arm A with arm C, 95% CI 28.1-56.6, p < 0.001 and 40.4% between arm B with arm C, 95% CI 24.6-56.2, p < 0.001).
","[{'ForeName': 'Kwame', 'Initials': 'K', 'LastName': 'Shanaube', 'Affiliation': 'Zambart, Lusaka, Zambia.'}, {'ForeName': 'Ab', 'Initials': 'A', 'LastName': 'Schaap', 'Affiliation': 'Zambart, Lusaka, Zambia.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Hoddinott', 'Affiliation': 'Desmond Tutu TB Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Mubekapi-Musadaidzwa', 'Affiliation': 'Desmond Tutu TB Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Floyd', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bock', 'Affiliation': 'Desmond Tutu TB Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fidler', 'Affiliation': 'Imperial College, London, UK & Imperial College NIHR BRC.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ayles', 'Affiliation': 'Zambart, Lusaka, Zambia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002722']
2595,33048877,Financial incentives to increase pediatric hiv testing: a randomized trial.,"BACKGROUND


Financial incentives (FI) can motivate desirable health behaviors, including adult HIV testing. Data regarding the effectiveness of FI for HIV testing in children, who require urgent testing to prevent mortality, are lacking.
METHODS


In a 5-arm unblinded randomized controlled trial, adults living with HIV attending 19 HIV clinics in Western Kenya, with children 0-12 years of unknown HIV status, were randomized with equal allocation to $0, $1.25, $2.50, $5 or $10. Payment was conditional on child HIV testing within 2 months. Block randomization with fixed block sizes was used; participants and study staff were unblinded at randomization. Primary analysis was intent-to-treat, with predefined primary outcomes of completing child HIV testing and time to testing.
RESULTS


Of 452 caregivers, 90, 89, 93, 92 and 88 were randomized to $0, $1.25, $2.50, $5.00, and $10.00, respectively. Of those, 31 (34%), 31 (35%), 44 (47%), 51 (55%), and 54 (61%) in the $0, $1.25, $2.50, $5.00, and $10.00 arms, respectively, completed child testing. Compared to the $0 arm, and adjusted for site, caregivers in the $10.00 arm had significantly higher uptake of testing (Relative risk: 1.80 [95%CI 1.15, 2.80] p = 0.010). Compared to the $0 arm, and adjusted for site, time to testing was significantly faster in the $5.00 and $10.00 arms (Hazard ratio: 1.95 [95%CI 1.24, 3.07] p = 0.004, 2.42 [95%CI 1.55, 3.79] p < 0.001, respectively).
CONCLUSIONS


FI are effective in improving pediatric HIV testing among caregivers living with HIV.
REGISTRATION


NCT03049917.",2020,"Compared to the $0 arm, and adjusted for site, time to testing was significantly faster in the $5.00 and $10.00 arms (Hazard ratio: 1.95 [95%CI 1.24, 3.07]","['Of 452 caregivers, 90, 89, 93, 92 and 88', 'caregivers living with HIV', 'adults living with HIV attending 19 HIV clinics in Western Kenya, with children 0-12 years of unknown HIV status']",[],"['child HIV testing and time to testing', 'pediatric HIV testing']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}]",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]",,0.47975,"Compared to the $0 arm, and adjusted for site, time to testing was significantly faster in the $5.00 and $10.00 arms (Hazard ratio: 1.95 [95%CI 1.24, 3.07]","[{'ForeName': 'Irene N', 'Initials': 'IN', 'LastName': 'Njuguna', 'Affiliation': 'Departments of Epidemiology, University of Washington, Box 359909, Seattle, WA 98104, USA.'}, {'ForeName': 'Anjuli D', 'Initials': 'AD', 'LastName': 'Wagner', 'Affiliation': 'Global Health, University of Washington, Box 359909, Seattle, WA 98104, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Neary', 'Affiliation': 'Global Health, University of Washington, Box 359909, Seattle, WA 98104, USA.'}, {'ForeName': 'Vincent O', 'Initials': 'VO', 'LastName': 'Omondi', 'Affiliation': 'Kenya Pediatric Research Consortium, Kenya Pediatric Association, P.O. Box 45820 - 0010, Nairobi, Kenya.'}, {'ForeName': 'Verlinda A', 'Initials': 'VA', 'LastName': 'Otieno', 'Affiliation': 'Kenya Pediatric Research Consortium, Kenya Pediatric Association, P.O. Box 45820 - 0010, Nairobi, Kenya.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Orimba', 'Affiliation': 'Biostatistics, University of Washington, Box 359909, Seattle, WA 98104, USA, Research and Programs, Kenyatta National Hospital, P.O. Box 20723-00202, Nairobi, Kenya.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Mugo', 'Affiliation': 'Global Health, University of Washington, Box 359909, Seattle, WA 98104, USA.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Babigumira', 'Affiliation': 'Global Health, University of Washington, Box 359909, Seattle, WA 98104, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Levin', 'Affiliation': 'Global Health, University of Washington, Box 359909, Seattle, WA 98104, USA.'}, {'ForeName': 'Barbra A', 'Initials': 'BA', 'LastName': 'Richardson', 'Affiliation': 'Global Health, University of Washington, Box 359909, Seattle, WA 98104, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Maleche-Obimbo', 'Affiliation': 'Department of Pediatrics and Child Health, University of Nairobi P.O. Box 19676 - 00202, Nairobi, Kenya.'}, {'ForeName': 'Dalton C', 'Initials': 'DC', 'LastName': 'Wamalwa', 'Affiliation': 'Department of Pediatrics and Child Health, University of Nairobi P.O. Box 19676 - 00202, Nairobi, Kenya.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'John-Stewart', 'Affiliation': 'Departments of Epidemiology, University of Washington, Box 359909, Seattle, WA 98104, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Slyker', 'Affiliation': 'Departments of Epidemiology, University of Washington, Box 359909, Seattle, WA 98104, USA.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002720']
2596,33048879,Changes in weight and body mass index with first-line doravirine-based therapy: a pooled analysis of three randomized controlled trials.,"OBJECTIVE


To evaluate changes in weight and body mass index in adults with HIV-1 at 1 and 2 years after starting an antiretroviral regimen that included doravirine, ritonavir-boosted darunavir, or efavirenz.
DESIGN


Post hoc analysis of pooled data from three randomized controlled trials.
METHODS


We evaluated weight change from baseline, weight gain ≥10%, and increase in body mass index (BMI) after 48 and 96 weeks of treatment with doravirine, ritonavir-boosted darunavir, or efavirenz-based regimens. Risk factors for weight gain and metabolic outcomes associated with weight gain were also examined.
RESULTS


Mean [and median] weight changes were similar for doravirine (1.7 [1.0] kg) and ritonavir-boosted darunavir (1.4 [0.6] kg) and were lower for efavirenz (0.6 [0.0] kg) at week 48 but were similar across all treatment groups at week 96 (2.4 [1.5], 1.8 [0.7], and 1.6 [1.0] kg, respectively). No significant differences between treatment groups were found in the proportion of participants with ≥10% weight gain or the proportion with BMI class increase at either time point. Low CD4+ T-cell count and high HIV-1 RNA at baseline were associated with ≥10% weight gain and BMI class increase at both timepoints, but treatment group, age, sex, and race were not.
CONCLUSIONS


Weight gains over 96 weeks were low in all treatment groups and were similar to the average yearly change in adults without HIV-1. Significant weight gain and BMI class increase were similar across the treatment groups and were predicted by low baseline CD4+ T-cell count and high baseline HIV-1 RNA.",2020,Significant weight gain and BMI class increase were similar across the treatment groups and were predicted by low baseline CD4+ T-cell count and high baseline HIV-1 RNA.,['adults with HIV-1 at 1 and 2 years after starting an antiretroviral regimen that included'],"['doravirine-based therapy', 'doravirine, ritonavir-boosted darunavir, or efavirenz-based regimens', 'doravirine, ritonavir-boosted darunavir, or efavirenz', 'efavirenz']","['Mean [and median] weight changes', 'weight and body mass index', 'weight gain or the proportion with BMI class increase', 'body mass index (BMI', 'weight gain', 'Significant weight gain and BMI class increase', 'Weight gains', 'Low CD4+ T-cell count and high HIV-1 RNA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C4045491', 'cui_str': 'DORAVIRINE'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}]",,0.0690866,Significant weight gain and BMI class increase were similar across the treatment groups and were predicted by low baseline CD4+ T-cell count and high baseline HIV-1 RNA.,"[{'ForeName': 'Orkin', 'Initials': 'O', 'LastName': 'Chloe', 'Affiliation': 'HIV Medicine, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Elion', 'Affiliation': 'George Washington University School of Medicine, Washington DC, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Thompson', 'Affiliation': 'AIDS Research Consortium of Atlanta, Atlanta, GA, USA.'}, {'ForeName': 'Juergen K', 'Initials': 'JK', 'LastName': 'Rockstroh', 'Affiliation': 'Medizinische Klinik und Poliklinik, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Fernando Alvarez', 'Initials': 'FA', 'LastName': 'Bognar', 'Affiliation': 'Global Medical Affairs, Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Zhi Jin', 'Initials': 'ZJ', 'LastName': 'Xu', 'Affiliation': 'Biostatistics, Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Hwang', 'Affiliation': 'Clinical Research, Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sklar', 'Affiliation': 'Clinical Research, Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Martin', 'Affiliation': 'Clinical Research, Merck & Co., Inc., Kenilworth, NJ, USA.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002725']
2597,33048901,Effect of Nonsedation on Cognitive Function in Survivors of Critical Illness.,"OBJECTIVES


Critical illness can cause severe cognitive impairments. The objective of this trial was to assess the effect of nonsedation versus sedation with a daily wake-up call during mechanical ventilation on cognitive function in adult survivors of critical illness.
DESIGN


Single-center substudy of the multicenter, randomized Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation trial. Three months after ICU-discharge participants were tested for cognitive function by a neuropsychologist.
SETTING


Mixed 14-bed ICU in teaching hospital.
PATIENTS


A total of 205 critically ill, orally intubated, and mechanically ventilated adults.
INTERVENTIONS


Patients were randomized within the first 24 hours from intubation to either nonsedation with sufficient analgesia or light sedation with a daily wake-up call during mechanical ventilation.
MEASUREMENTS AND MAIN RESULTS


A total of 118 patients survived to follow-up and 89 participated (75%). The participating survivors in the two groups did not differ regarding baseline data or premorbid cognitive impairments. Sedated patients had received more sedatives, whereas doses of morphine and antipsychotics were equal. The primary outcome was that no significant difference was found in the number of patients with mild/moderate cognitive impairments (six nonsedated patients vs four sedated patients) or severe cognitive impairments (16 nonsedated patients vs 17 sedated patients; p = 0.71). Secondary outcomes were cognitive test scores, and no differences were found between the scores in nonsedated and sedated patients. Hypothetical worst case scenarios where all patients, who had not participated in follow-up assessment, were assumed to have severe cognitive impairments were analyzed, but still no difference between the groups was found. We found more patients with delirium in the sedated group (96% vs 69% of patients; p = 0.002) and increased duration of delirium in sedated patients (median 5 vs 1 d; p < 0.001). Delirium subtypes were equally distributed between the groups, with hypoactive delirium most frequent (61%), followed by mixed delirium (39%).
CONCLUSIONS


Nonsedation did not affect cognitive function 3 months after ICU-discharge.",2020,"Secondary outcomes were cognitive test scores, and no differences were found between the scores in nonsedated and sedated patients.","['118 patients survived to follow-up and 89 participated (75', 'Survivors of Critical Illness', 'adult survivors of critical illness', 'Critically Ill Patients Receiving Mechanical Ventilation trial', '205 critically ill, orally intubated, and mechanically ventilated adults', 'Mixed 14-bed ICU in teaching hospital']","['sedation Versus Sedation', 'morphine and antipsychotics', 'nonsedation with sufficient analgesia or light sedation with a daily wake-up call during mechanical ventilation', 'nonsedation versus sedation with a daily wake-up call during mechanical ventilation']","['Delirium subtypes', 'delirium', 'severe cognitive impairments', 'Cognitive Function', 'cognitive test scores', 'cognitive function', 'duration of delirium', 'premorbid cognitive impairments', 'number of patients with mild/moderate cognitive impairments']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C3554639', 'cui_str': 'Severe cognitive impairment'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C3839816', 'cui_str': 'Moderate cognitive impairment'}]",205.0,0.186786,"Secondary outcomes were cognitive test scores, and no differences were found between the scores in nonsedated and sedated patients.","[{'ForeName': 'Helene Korvenius', 'Initials': 'HK', 'LastName': 'Nedergaard', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Lillebaelt Hospital Kolding, University Hospital of Southern Denmark, Kolding, Denmark.'}, {'ForeName': 'Hanne Irene', 'Initials': 'HI', 'LastName': 'Jensen', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Lillebaelt Hospital Kolding, University Hospital of Southern Denmark, Kolding, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Stylsvig', 'Affiliation': 'Clinic of Neuropsychology, Odense, Denmark.'}, {'ForeName': 'Hanne Tanghus', 'Initials': 'HT', 'LastName': 'Olsen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Korkmaz', 'Affiliation': 'Department of Business and Economics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Strøm', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Palle', 'Initials': 'P', 'LastName': 'Toft', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark.'}]",Critical care medicine,['10.1097/CCM.0000000000004573']
2598,33049035,"No changes in HIV suppression and inflammatory markers in CSF in patients randomly switched to DTG + 3TC (Spanish HIV/AIDS Research Network, PreEC/RIS 62).","A major concern of HIV dual therapy is a potential lower efficacy in viral reservoirs, especially in the central nervous system (CNS). We evaluated HIV RNA, neuronal injury and inflammatory biomarkers and dolutegravir (DTG) exposure in cerebrospinal fluid (CSF) in patients switching to DTG+lamivudine (3TC). All participants maintained viral suppression in plasma and CSF at week 48. We observed no increase in CSF markers of inflammation or neuronal injury. Median (IQR) total and unbound DTG in CSF were 7.3(5.9-8.4) ng/mL and 1.7(1.2-1.9) ng/mL, respectively. DTG+3TC may maintain viral control without changes in inflammatory/injury markers within the CNS reservoir.",2020,We observed no increase in CSF markers of inflammation or neuronal injury.,['patients switching to DTG+lamivudine (3TC'],"['DTG + 3TC', 'DTG+3TC']","['Median (IQR) total and unbound DTG in CSF', 'viral suppression in plasma and CSF', 'HIV suppression and inflammatory markers', 'CSF markers of inflammation or neuronal injury', 'HIV RNA, neuronal injury and inflammatory biomarkers and dolutegravir (DTG) exposure in cerebrospinal fluid (CSF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.034038,We observed no increase in CSF markers of inflammation or neuronal injury.,"[{'ForeName': 'Juan M', 'Initials': 'JM', 'LastName': 'Tiraboschi', 'Affiliation': 'Bellvitge University Hospital. Bellvitge Biomedical Research Institute. University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jhon', 'Initials': 'J', 'LastName': 'Rojas', 'Affiliation': 'Infectious diseases Service, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Zetterberg', 'Affiliation': 'Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Kaj', 'Initials': 'K', 'LastName': 'Blennow', 'Affiliation': 'Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Niubo', 'Affiliation': 'Bellvitge University Hospital. Bellvitge Biomedical Research Institute. University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Gostner', 'Affiliation': 'Innsbruck Medical University, Innsbrusk, Austria.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Navarro-Alcaraz', 'Affiliation': 'Bellvitge University Hospital. Bellvitge Biomedical Research Institute. University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Piatti', 'Affiliation': 'Bellvitge University Hospital. Bellvitge Biomedical Research Institute. University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Fuchs', 'Affiliation': 'Innsbruck Medical University, Innsbrusk, Austria.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Gisslén', 'Affiliation': 'Department of Infectious Diseases, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Rigo-Bonnin', 'Affiliation': 'Pharmacology Service, Bellvitge University Hospital, Barcelona. Spain.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': 'Infectious diseases Service, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Podzamczer', 'Affiliation': 'Bellvitge University Hospital. Bellvitge Biomedical Research Institute. University of Barcelona, Barcelona, Spain.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa645']
2599,33049054,Midostaurin in patients with acute myeloid leukemia and FLT3-TKD mutations: a subanalysis from the RATIFY trial.,"The results from the RATIFY trial (ClinicalTrials.gov: NCT00651261; CALGB 10603) showed that midostaurin combined with standard chemotherapy significantly improved outcomes in patients with FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukemia (AML), compared with placebo. In this post hoc subgroup analysis from the trial, we evaluated the impact of midostaurin in 163 patients with FLT3-tyrosine kinase domain (TKD) mutations. At a median follow-up of 60.7 months (95% CI, 55.0-70.8), the 5-year event-free survival (EFS) rate was significantly higher in patients treated with midostaurin than in those treated with placebo (45.2% vs 30.1%; P = .044). A trend toward improved disease-free survival was also observed with midostaurin (67.3% vs 53.4%; P = .089), whereas overall survival (OS) was similar in the 2 groups. Patients with AML and NPM1mut/FLT3-TKDmut or core binding factor (CBF)-rearranged/FLT3-TKDmut genotypes had significantly prolonged OS with or without censoring at hematopoietic cell transplantation (HCT), compared with NPM1WT/CBF-negative AMLs. The multivariable model for OS and EFS adjusted for allogeneic HCT in first complete remission as a time-dependent covariable, revealed NPM1 mutations and CBF rearrangements as significant favorable factors. These data show that NPM1 mutations or CBF rearrangements identify favorable prognostic groups in patients with FLT3-TKD AMLs, independent of other factors, also in the context of midostaurin treatment.",2020,"A trend toward improved disease-free survival was also observed with midostaurin (67.3% vs 53.4%; P = .089), whereas overall survival (OS) was similar in the 2 groups.","['163 patients with FLT3-tyrosine kinase domain (TKD) mutations', 'patients with acute myeloid leukemia and FLT3-TKD mutations', 'patients with FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukemia (AML']","['placebo', 'midostaurin combined with standard chemotherapy', 'Midostaurin', 'midostaurin']","['5-year event-free survival (EFS) rate', 'disease-free survival', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0287186', 'cui_str': 'Fetal Liver Kinase-2'}, {'cui': 'C0033681', 'cui_str': 'Protein-tyrosine kinase'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0526371', 'cui_str': 'midostaurin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",163.0,0.0988437,"A trend toward improved disease-free survival was also observed with midostaurin (67.3% vs 53.4%; P = .089), whereas overall survival (OS) was similar in the 2 groups.","[{'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Voso', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Larson', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Marcucci', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Prior', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Krauter', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Medical School, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heuser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Medical School, Hannover, Germany.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Lavorgna', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Nomdedeu', 'Affiliation': 'Hematology Department, Hospital de la Santa Creu I Sant Pau and José Carreras Leukemia Research Institute, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Geyer', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, NY.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Walker', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Wei', 'Affiliation': 'Department of Clinical Hematology, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Sierra', 'Affiliation': 'Hematology Department, Hospital de la Santa Creu I Sant Pau and José Carreras Leukemia Research Institute, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Sanz', 'Affiliation': 'Department of Hematology, Hospital Universitari i Politecnic La Fe, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Brandwein', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Theo M', 'Initials': 'TM', 'LastName': 'de Witte', 'Affiliation': 'Department of Tumor Immunology, Nijmegen Centre of Life Sciences, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Joop H', 'Initials': 'JH', 'LastName': 'Jansen', 'Affiliation': 'Department of Tumor Immunology, Nijmegen Centre of Life Sciences, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Dietger', 'Initials': 'D', 'LastName': 'Niederwieser', 'Affiliation': 'Department of Hematology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Frederick R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Bruno C', 'Initials': 'BC', 'LastName': 'Medeiros', 'Affiliation': 'Division of Hematology, Stanford Comprehensive Cancer Center, Stanford University, Stanford, CA.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Tallman', 'Affiliation': 'Division of Hematologic Malignancies, Leukemia Service, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Medical School, Hannover, Germany.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Amadori', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'YinMiao', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Pallaud', 'Affiliation': 'Novaremed AG, Basel, Switzerland.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Du', 'Affiliation': 'Novartis Pharmaceuticals Corporation, Cambridge, MA.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Piciocchi', 'Affiliation': 'GIMEMA Data Center, Rome, Italy.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Ehninger', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus der TU Dresden, Dresden, Germany; and.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Byrd', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thiede', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus der TU Dresden, Dresden, Germany; and.'}, {'ForeName': 'Konstanze', 'Initials': 'K', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Stone', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Clara D', 'Initials': 'CD', 'LastName': 'Bloomfield', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Lo-Coco', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy.'}]",Blood advances,['10.1182/bloodadvances.2020002904']
2600,33049114,Cognitive outcomes in trials of two BACE inhibitors in Alzheimer's disease.,"INTRODUCTION


The APECS and AMARANTH trials showed that beta-secretase (BACE) inhibitors verubecestat and lanabecestat failed to slow cognitive and functional decline in individuals with prodromal or early Alzheimer's disease. Here, the performance on secondary and exploratory cognitive measures in both studies is reported.
METHODS


APECS (verubecestat) and AMARANTH (lanabecestat) were randomized, double-blind, placebo-controlled, parallel-group, 104-week clinical trials conducted by different sponsors. Measures included the 3-Domain Composite Cognition Score (CCS-3D), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Letter/Category Fluency, and Digit Symbol Coding.
RESULTS


Verubecestat showed worsening on the CCS-3D Total Score, Episodic Memory, and Attention/Processing Speed domains. Lanabecestat showed worsening on the RBANS Total Score, Immediate Memory, and Visuospatial/Constructional Indexes. Both BACE inhibitors showed worsening on Digit Symbol Coding and improvements on Letter/Category Fluency.
DISCUSSION


In both studies, many measures showed treatment-associated cognitive worsening, whereas verbal fluency tasks showed improvement.",2020,"Lanabecestat showed worsening on the RBANS Total Score, Immediate Memory, and Visuospatial/Constructional Indexes.","['APECS (verubecestat) and AMARANTH (lanabecestat', ""individuals with prodromal or early Alzheimer's disease"", ""Alzheimer's disease""]","['placebo', 'BACE inhibitors']","['3-Domain Composite Cognition Score (CCS-3D), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Letter/Category Fluency, and Digit Symbol Coding', 'verbal fluency tasks', 'CCS-3D Total Score, Episodic Memory, and Attention/Processing Speed domains', 'RBANS Total Score, Immediate Memory, and Visuospatial/Constructional Indexes', 'Digit Symbol Coding and improvements on Letter/Category Fluency']","[{'cui': 'C0002406', 'cui_str': 'Amaranth Dye'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1454853', 'cui_str': 'beta-Secretase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0715989,"Lanabecestat showed worsening on the RBANS Total Score, Immediate Memory, and Visuospatial/Constructional Indexes.","[{'ForeName': 'Alette M', 'Initials': 'AM', 'LastName': 'Wessels', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lines', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Stern', 'Affiliation': ""Alzheimer's\xa0Disease\xa0Center, Boston University School of Medicine, Boston, Massachusetts, USA.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kost', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Tiffini', 'Initials': 'T', 'LastName': 'Voss', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Lyn Harper', 'Initials': 'LH', 'LastName': 'Mozley', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Furtek', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Mukai', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Aisen', 'Affiliation': 'University of Southern California, San Diego, California, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Cummings', 'Affiliation': 'Department of Brain Health, School of Integrated Health Sciences, University of Nevada Las Vegas (UNLV) and Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, Nevada, USA.'}, {'ForeName': 'Pierre N', 'Initials': 'PN', 'LastName': 'Tariot', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': ""Gerontopole, INSERM U1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Dupre', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Randolph', 'Affiliation': 'MedAvante-ProPhase, Hamilton, NJ and Department of Neurology, Loyola University Medical Center, Maywood, Illinois, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Michelson', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'Andersen', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Shering', 'Affiliation': 'AstraZeneca, Boston, Massachusetts, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Sims', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Egan', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1002/alz.12164']
2601,33049118,Continuous lenalidomide and low-dose dexamethasone in patients with transplant-ineligible newly diagnosed MM: FIRST trial subanalysis of Canadian/US patients.,"The phase 3 FIRST trial demonstrated significant improvement in progression-free survival (PFS) and overall survival (OS) with an immune-stimulatory agent, lenalidomide, in combination with low-dose dexamethasone until disease progression (Rd continuous) vs melphalan +prednisone + thalidomide (MPT) in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). Rd continuous similarly extended PFS vs fixed-duration Rd for 18 cycles (Rd18). Outcomes in the Canadian/US subgroup (104 patients per arm) are reported in this analysis. Rd continuous demonstrated a significant improvement in PFS vs MPT (median, 29.3 vs 20.2 months; HR, 0.69 [95% CI, 0.49-0.97]; p = 0.03326) and an improvement vs Rd18 (median, 21.9 months). Median OS was 56.9 vs 46.8 months with Rd continuous vs MPT (p = 0.15346) and 59.5 months with Rd18. The overall response rate was higher with Rd continuous and Rd18 (78.8% and 79.8%) vs MPT (65.4%). In the 49.0%, 52.9%, and 29.8% of patients with at least very good partial response in the Rd continuous, Rd18, and MPT arms, respectively, the median PFS was 56.0, 30.9, and 40.2 months, respectively. The most common grade 3/4 treatment-emergent adverse events were neutropenia (28.4%, 30.1%, and 52.0%), anemia (23.5%, 21.4%, and 23.5%), and infections (37.3%, 30.1%, and 24.5%) with Rd continuous, Rd18, and MPT, respectively. These results were consistent with those in the intent-to-treat population, confirming the benefit of Rd continuous vs MPT in the Canadian/US subgroup and supporting the role of Rd continuous as a standard of care for transplant-ineligible patients with NDMM.",2020,Median OS was 56.9 vs 46.8 months with Rd continuous vs MPT (p = 0.15346) and 59.5 months with Rd18.,"['patients with transplant-ineligible newly diagnosed MM', 'transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM']","['melphalan +prednisone + thalidomide (MPT', 'Continuous lenalidomide and low-dose dexamethasone']","['PFS vs MPT', 'good partial response', 'infections', 'progression-free survival (PFS) and overall survival (OS', 'overall response rate', 'anemia', 'neutropenia', 'Median OS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}]","[{'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0512246,Median OS was 56.9 vs 46.8 months with Rd continuous vs MPT (p = 0.15346) and 59.5 months with Rd18.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Belch', 'Affiliation': 'Cross Cancer Institute, Edmonton, AB, Canada.'}, {'ForeName': 'Nizar', 'Initials': 'N', 'LastName': 'Bahlis', 'Affiliation': 'Tom Baker Cancer Centre, Calgary, AB, Canada.'}, {'ForeName': 'Darrell', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Dalhousie University and Queen Elizabeth II Health Sciences Centre, Halifax, NS, Canada.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cheung', 'Affiliation': 'Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Chaim', 'Initials': 'C', 'LastName': 'Shustik', 'Affiliation': 'McGill University Health Centre, Montréal, QC, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Song', 'Affiliation': 'Leukemia/Bone Marrow Transplant Program of British Columbia, Division of Hematology, Vancouver General Hospital, Vancouver, BC, Canada.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Tosikyan', 'Affiliation': 'Hôpital du Sacré-Coeur de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Dispenzieri', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Celgene, a Bristol-Myers Squibb Company, Mississauga, ON, Canada.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'Celgene, a Bristol-Myers Squibb Company, Boudry, Switzerland.'}, {'ForeName': 'Shankar', 'Initials': 'S', 'LastName': 'Srinivasan', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Facon', 'Affiliation': 'Service des Maladies du Sang, Hôpital Claude Huriez, Lille, France.'}]",Cancer medicine,['10.1002/cam4.3511']
2602,33049411,The effect of multiple-dose oral versus intravenous tranexamic acid in reducing postoperative blood loss and transfusion rate after adolescent scoliosis surgery: A randomized controlled trial.,"BACKGROUND CONTEXT


Tranexamic acid (TXA) is widely used in surgery for adolescent idiopathic scoliosis (AIS) and has been proved to be efficacious in reducing intraoperative blood loss (IBL) and the transfusion rate. However, the routine TXA regimen was intraoperative administration alone, in which the concentration of TXA could not cover the whole process of hyperfibrinolysis. And, its ability to control the massive postoperative blood loss (PBL) may be insufficient. Thus, we promoted a multiple-dose regimen of TXA for patients with AIS who underwent surgical correction.
PURPOSE


The primary aims were (1) to determine whether the multiple-dose regimen of TXA could reduce PBL and the postoperative transfusion rate, and (2) to compare the efficacy of oral administration with intravenous administration. The secondary aims were (3) to evaluate whether this regimen could alleviate inflammatory response, and (4) to assess the occurrence of drug-related side effects.
STUDY DESIGN


Prospective, double-blinded, randomized controlled trial PATIENT SAMPLE: A total of 108 patients with AIS who underwent posterior scoliosis correction and spinal fusion (PSS) were enrolled in this study.
OUTCOME MEASURES


The primary parameters were PBL and postoperative transfusion rate. Other parameters such as total blood loss (TBL), maximum hemoglobin (Hb) decrease, volume of drainage, inflammation markers [interleukin-6 (IL-6) and C-reactive protein (CRP)], and occurrence of complications were also collected and compared. Multiple regression analysis was used to examine the variables that affected PBL.
METHOD


Patients were randomized into three groups. All patients received intravenous TXA 50 mg/kg loading dose and 10 mg/kg/h maintenance dose during surgery. Group A received 1 g oral TXA at 4 h, 10 h, and 16 h postoperatively; group B received 0.5 g intravenous TXA at 6 h, 12 h, and 18 h postoperatively; group C received placebo.
RESULTS


The mean PBL and postoperative transfusion rate in group A (957.8±378.9 mL, 13.89%) and B (980.3±491.8 mL, 11.11%) were significantly lower than those in group C [1495.9±449.6 mL, mean differences = 538.1 mL, 95% confidence interval (CI), 290.1-786.1 mL, p<0.001; 515.6 mL, 95% CI, 267.6-763.6 mL, p<0.001]; (36.11%, p=0.029, p=0.013). Meanwhile, the mean TBL, maximum Hb decrease, and volume of drainage were also significantly lower in group A and B than in group C. IL-6 and CRP in group A and B were significantly lower than in group C from postoperative days 1 to 3. All these differences were not significant between groups A and B. No drug-related complications were observed in any patient. Multiple regression showed that the application of postoperative TXA and number of screws were significant parameters affecting PBL.
CONCLUSION


A multiple-dose regimen of TXA, either by oral or intravenous application, could be a safe and effective means of controlling PBL and decreasing the postoperative transfusion rate in patients with AIS who underwent scoliosis surgery. In addition, it could inhibit postoperative inflammatory response.",2020,All these differences were not significant between groups A and B. No drug-related complications were observed in any patient.,"['adolescent idiopathic scoliosis (AIS', 'Patients', 'adolescent scoliosis surgery', 'patients with AIS who underwent surgical correction', '108 patients with AIS who underwent posterior scoliosis correction and spinal fusion (PSS', 'patients with AIS who underwent scoliosis surgery', 'SAMPLE']","['Tranexamic acid (TXA', 'intravenous TXA', 'tranexamic acid', 'placebo', '1 g oral TXA', 'TXA']","['PBL and the postoperative transfusion rate', 'total blood loss (TBL), maximum hemoglobin (Hb) decrease, volume of drainage, inflammation markers [interleukin-6 (IL-6) and C-reactive protein (CRP)], and occurrence of complications', 'postoperative blood loss and transfusion rate', 'postoperative transfusion rate', 'mean TBL, maximum Hb decrease, and volume of drainage', 'mean PBL and postoperative transfusion rate', 'PBL and postoperative transfusion rate', 'occurrence of drug-related side effects']","[{'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0854477', 'cui_str': 'Scoliosis surgery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0408736', 'cui_str': 'Correction of scoliosis'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",108.0,0.105372,All these differences were not significant between groups A and B. No drug-related complications were observed in any patient.,"[{'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Research Institute, West China Hospital, Sichuan University. No.37, Guoxue Road, Wuhou district, Chengdu, 610041, Si chuan, People's Republic of China. Electronic address: spk4177710@sina.com.""}, {'ForeName': 'Lin-Nan', 'Initials': 'LN', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Research Institute, West China Hospital, Sichuan University. No.37, Guoxue Road, Wuhou district, Chengdu, 610041, Si chuan, People's Republic of China.""}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Research Institute, West China Hospital, Sichuan University. No.37, Guoxue Road, Wuhou district, Chengdu, 610041, Si chuan, People's Republic of China.""}, {'ForeName': 'Li-Min', 'Initials': 'LM', 'LastName': 'Liu', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Research Institute, West China Hospital, Sichuan University. No.37, Guoxue Road, Wuhou district, Chengdu, 610041, Si chuan, People's Republic of China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Xiu', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Research Institute, West China Hospital, Sichuan University. No.37, Guoxue Road, Wuhou district, Chengdu, 610041, Si chuan, People's Republic of China.""}, {'ForeName': 'Zhong-Jie', 'Initials': 'ZJ', 'LastName': 'Zhou', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Research Institute, West China Hospital, Sichuan University. No.37, Guoxue Road, Wuhou district, Chengdu, 610041, Si chuan, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Research Institute, West China Hospital, Sichuan University. No.37, Guoxue Road, Wuhou district, Chengdu, 610041, Si chuan, People's Republic of China.""}, {'ForeName': 'Yue-Ming', 'Initials': 'YM', 'LastName': 'Song', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Research Institute, West China Hospital, Sichuan University. No.37, Guoxue Road, Wuhou district, Chengdu, 610041, Si chuan, People's Republic of China. Electronic address: prof_songyueming@163.com.""}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.10.011']
2603,33049424,The impact of prior and ongoing threat on the false alarm threshold for facial discrimination.,"BACKGROUND AND OBJECTIVES


Perceptual adaptations that facilitate rapid responses to threats can also lead to false alarms, or the failure to discriminate safe stimuli from signals of threat. We examined the impact of varying degrees of threat on false alarms in the perceptual discrimination of faces along the dimension of emotion (Experiment 1) or identity (Experiment 2).
METHODS


Participants first trained to discriminate between a target and nontarget face. Next, we tested their ability to identify the target in randomized presentations of the target, the nontarget, and nine novel stimuli morphed in 10% increments of similarity from the target to the nontarget. The task was completed under one of three randomized conditions: 1) Ongoing-Threat paired the target with an aversive outcome in both phases; 2) Prior-Threat paired the target with an aversive outcome in the training phase only; and 3) No-Threat paired the target with a neutral outcome in the training phase only.
RESULTS


In Experiment 1 (N = 90), Ongoing-Threat lowered the false alarm threshold for facial discrimination based on anger intensity compared to Prior-Threat and No-Threat. In Experiment 2 (N = 90), Ongoing-Threat and Prior-Threat each lowered the false alarm threshold for identity-based discrimination compared to No-Threat.
LIMITATIONS


The experiment did not measure generalization of threat responses.
CONCLUSION


Associating a facial expression or identity with threat leads to faster but less accurate discrimination of faces with similar features, particularly under conditions of ongoing threat. These experiments provide an avenue for examining the parameters that impact false alarms, which play a key role in anxiety disorders.",2020,"In Experiment 1 (N = 90), Ongoing-Threat lowered the false alarm threshold for facial discrimination based on anger intensity compared to Prior-Threat and No-Threat.",['Participants first trained to discriminate between a target and nontarget face'],[],[],"[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205235', 'cui_str': 'Discriminate'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]",[],[],,0.0222255,"In Experiment 1 (N = 90), Ongoing-Threat lowered the false alarm threshold for facial discrimination based on anger intensity compared to Prior-Threat and No-Threat.","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Papini', 'Affiliation': 'The University of Texas at Austin, USA. Electronic address: spapini@utexas.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Dunsmoor', 'Affiliation': 'The University of Texas at Austin, USA.'}, {'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'The University of Texas at Austin, USA.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101619']
2604,33049433,Selecting the optimal treatment for a depressed individual: Clinical judgment or statistical prediction?,"BACKGROUND


Optimizing treatment selection is a way to enhance treatment success in major depressive disorder (MDD). In clinical practice, treatment selection heavily depends on clinical judgment. However, research has consistently shown that statistical prediction is as accurate - or more accurate - than predictions based on clinical judgment. In the context of new technological developments, the current aim was to compare the accuracy of clinical judgment versus statistical predictions in selecting cognitive therapy (CT) or interpersonal psychotherapy (IPT) for MDD.
METHODS


Data came from a randomized trial comparing CT (n=76) with IPT (n=75) for MDD. Prior to randomization, therapists' recommendations were formulated during multidisciplinary staff meetings. Statistical predictions were based on Personalized Advantage Index models. Primary outcomes were post-treatment and 17-month follow-up depression severity. Secondary outcome was treatment dropout.
RESULTS


Individuals receiving treatment according to their statistical prediction were less depressed at post-treatment and follow-up compared to those receiving their predicted non-indicated treatment. This difference was not found for recommended versus non-recommended treatments based on clinical judgment. Moreover, for individuals with an IPT recommendation by therapists, higher post-treatment and follow-up depression severity was found for those that actually received IPT compared to those that received CT. Recommendations based on statistical prediction and clinical judgment were not associated with differences in treatment dropout.
LIMITATIONS


Information on the clinical reasoning behind therapist recommendations was not collected, and statistical predictions were not externally validated.
CONCLUSIONS


Statistical prediction outperforms clinical judgment in treatment selection for MDD and has the potential to personalize treatment strategies.",2020,"RESULTS


Individuals receiving treatment according to their statistical prediction were less depressed at post-treatment and follow-up compared to those receiving their predicted non-indicated treatment.","['n=76) with IPT (n=75) for MDD', 'major depressive disorder (MDD']","['CT', 'IPT', 'cognitive therapy (CT) or interpersonal psychotherapy (IPT']","['treatment dropout', 'post-treatment and 17-month follow-up depression severity']","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}]","[{'cui': 'C0030686', 'cui_str': 'Patient Dropouts'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",76.0,0.0177431,"RESULTS


Individuals receiving treatment according to their statistical prediction were less depressed at post-treatment and follow-up compared to those receiving their predicted non-indicated treatment.","[{'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'van Bronswijk', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200, MD Maastricht, the Netherlands. Electronic address: suzanne.vanbronswijk@maastrichtuniversity.nl.'}, {'ForeName': 'Lotte H J M', 'Initials': 'LHJM', 'LastName': 'Lemmens', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200, MD Maastricht, the Netherlands.'}, {'ForeName': 'Marcus J H', 'Initials': 'MJH', 'LastName': 'Huibers', 'Affiliation': 'Department of Clinical Psychology, VU University Amsterdam, Van der Boechorststraat 1, 1081 BT Amsterdam, the Netherlands; Department of Psychology, University of Pennsylvania, 3720 Walnut Street, Philadelphia, PA 19104-6241, USA.'}, {'ForeName': 'Frenk P M L', 'Initials': 'FPML', 'LastName': 'Peeters', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200, MD Maastricht, the Netherlands.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.135']
2605,33049434,Acute Effects of Cannabis on Symptoms of Obsessive-Compulsive Disorder.,"BACKGROUND


Little is known about the the acute effects of cannabis on symptoms of OCD in humans. Therefore, this study sought to: 1) examine whether symptoms of OCD are significantly reduced after inhaling cannabis, 2) examine predictors (gender, dose, cannabis constituents, time) of these symptom changes and 3) explore potential long-term consequences of repeatedly using cannabis to self-medicate for OCD symptoms, including changes in dose and baseline symptom severity over time.
METHOD


Data were analyzed from the app Strainprint® which provides medical cannabis patients a means of tracking changes in symptoms as a function of different doses and strains of cannabis across time. Specifically, data were analyzed from 87 individuals self-identifying with OCD who tracked the severity of their intrusions, compulsions, and/or anxiety immediately before and after 1,810 cannabis use sessions spanning a period of 31 months.
RESULTS


Patients reported a 60% reduction in compulsions, a 49% reduction in intrusions, and a 52% reduction in anxiety from before to after inhaling cannabis. Higher concentrations of CBD and higher doses predicted larger reductions in compulsions. The number of cannabis use sessions across time predicted changes in intrusions, such that later cannabis use sessions were associated with smaller reductions in intrusions. Baseline symptom severity and dose remained fairly constant over time.
LIMITATIONS


The sample was self-selected, self-identified as having OCD, and there was no placebo control group.
CONCLUSIONS


Inhaled cannabis appears to have short-term beneficial effects on symptoms of OCD. However, tolerance to the effects on intrusions may develop over time.",2020,"RESULTS


Patients reported a 60% reduction in compulsions, a 49% reduction in intrusions, and a 52% reduction in anxiety from before to after inhaling cannabis.","['87 individuals self-identifying with OCD who tracked the severity of their intrusions, compulsions, and/or anxiety immediately before and after 1,810 cannabis use sessions spanning a period of 31 months', 'Data were analyzed from the app Strainprint® which provides medical cannabis patients a means of tracking changes in symptoms as a function of different doses and strains of cannabis across time']",['Cannabis'],"['Symptoms of Obsessive-Compulsive Disorder', 'anxiety', 'compulsions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0813973', 'cui_str': 'Medical Cannabis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}]",,0.034413,"RESULTS


Patients reported a 60% reduction in compulsions, a 49% reduction in intrusions, and a 52% reduction in anxiety from before to after inhaling cannabis.","[{'ForeName': 'Dakota', 'Initials': 'D', 'LastName': 'Mauzay', 'Affiliation': 'Washington State University, Department of Psychology, Pullman, WA, US.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'LaFrance', 'Affiliation': 'Washington State University, Department of Psychology, Pullman, WA, US.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Cuttler', 'Affiliation': 'Washington State University, Department of Psychology, Pullman, WA, US. Electronic address: carrie.cuttler@wsu.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.124']
2606,33049455,The effectiveness of brief animated films as a scalable micro-intervention to improve children's body image: A randomised controlled trial.,"Creating media to counteract the plethora of media and advertising that perpetuates negative body image is a scalable public health strategy that can be achieved through innovative micro-interventions. This study examined the immediate and short-term (one-week follow-up) impact of viewing brief, evidence-informed animated films on young people's body image, media literacy, and self-efficacy in addressing appearance teasing. The animations were co-created through a partnership among academics, a personal care brand's social mission, and a children's television channel. Participants aged 7-14 (N = 1329, 49 % girls) were randomised into one of three viewing conditions: Appearance Teasing & Bullying, Media & Celebrities, or a non-appearance-related animation. Contrary to predictions, all three animations were comparably effective at eliciting intervention effects. For girls and boys aged 7-10, all three animations immediately improved state body satisfaction (+boys aged 11-14; Cohen's ds = .60-.71) and led to sustained improvements in trait media literacy (+girls aged 11-14; ds = .38-.61), sensitivity to appearance teasing (+boys aged 11-14; ds = .35-.48), and willingness to ignore appearance teasing (7-10 years only; ds = .34-.74) at one-week follow-up. Findings indicate that children's media is an effective medium for developing micro-interventions.",2020,"For girls and boys aged 7-10, all three animations immediately improved state body satisfaction (+boys aged 11-14; Cohen's ds = .60-.71) and led to sustained improvements in trait media literacy (+girls aged 11-14; ds = .38-.61), sensitivity to appearance teasing (+boys aged 11-14; ds = .35-.48), and willingness to ignore appearance teasing (7-10 years only; ds = .34-.74) at one-week follow-up.","['Participants aged 7-14 (N = 1329, 49 % girls', ""children's body image""]","['viewing brief, evidence-informed animated films']","['state body satisfaction', 'trait media literacy', 'sensitivity to appearance teasing']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C1704608', 'cui_str': 'Film'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C4721445', 'cui_str': 'Teasing'}]",,0.0220831,"For girls and boys aged 7-10, all three animations immediately improved state body satisfaction (+boys aged 11-14; Cohen's ds = .60-.71) and led to sustained improvements in trait media literacy (+girls aged 11-14; ds = .38-.61), sensitivity to appearance teasing (+boys aged 11-14; ds = .35-.48), and willingness to ignore appearance teasing (7-10 years only; ds = .34-.74) at one-week follow-up.","[{'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Matheson', 'Affiliation': 'Centre for Appearance Research, Department of Health and Social Sciences, University of the West of England, Coldharbour Lane, Bristol, BS16 1QY, UK. Electronic address: emily.matheson@uwe.ac.uk.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Lewis-Smith', 'Affiliation': 'Centre for Appearance Research, Department of Health and Social Sciences, University of the West of England, Coldharbour Lane, Bristol, BS16 1QY, UK.'}, {'ForeName': 'Phillippa C', 'Initials': 'PC', 'LastName': 'Diedrichs', 'Affiliation': 'Centre for Appearance Research, Department of Health and Social Sciences, University of the West of England, Coldharbour Lane, Bristol, BS16 1QY, UK.'}]",Body image,['10.1016/j.bodyim.2020.08.015']
2607,33062927,Impact of Patient Characteristics on Treatment Outcomes in Symptomatic Venous Thromboembolism: Results of HOKUSAI-VTE Randomized Trial Analysis.,"Introduction   In patients with venous thromboembolism (VTE), direct oral anticoagulants (DOACs) such as edoxaban, apixaban, dabigatran, and rivaroxaban are more convenient, safer, and just as effective as vitamin K antagonists (VKAs). Limited information is known about the effects of patient characteristics on VTE efficacy and safety of DOACs compared with VKAs, without appropriate effect modifier adjustment comparisons of DOACs may be biased. This study considers the effect of variables that can modify the efficacy and safety of edoxaban and warfarin, using patient-level data.  Materials and Methods   The primary efficacy and safety outcomes in the HOKUSAI-VTE study were VTE recurrence and clinically relevant bleeding, respectively. Potential effect modifiers were age, creatinine clearance, and weight. The relationship between the percentage of time in international normalized ratio (INR) control and outcomes were considered for the warfarin arm. Univariate and multivariate regression were performed for each patient characteristic.  Results   The relationship between treatment and VTE recurrence differed by age (interaction  p   = 0.007) and by creatinine clearance (  p   = 0.05). VTE recurrence differed by age for patients in the warfarin arm but not for those in the edoxaban arm and differed by INR control in the warfarin arm (  p   < 0.005). A stronger relationship between creatinine clearance and clinically relevant bleeding was found in the warfarin arm than in the edoxaban arm (  p   = 0.04). Clinically relevant bleeding differed by the percentage of time in INR control in the warfarin arm (  p   < 0.005). Age appeared to be a more important effect modifier than creatinine clearance in patients with VTE.  Discussion   The finding that efficacy in older patients was greater for those taking edoxaban than for those taking warfarin in the HOKUSAI-VTE study needs further investigation. Modification of the treatment effect by age for those taking warfarin might bias estimates of comparative effectiveness among DOACs if VKAs are the reference treatment.",2020,A stronger relationship between creatinine clearance and clinically relevant bleeding was found in the warfarin arm than in the edoxaban arm (  p   = 0.04).,"['Symptomatic Venous Thromboembolism', 'patients with venous thromboembolism (VTE), direct oral anticoagulants (DOACs) such as', 'older patients', 'patients with VTE']","['edoxaban, apixaban, dabigatran, and rivaroxaban', 'edoxaban', 'edoxaban and warfarin', 'warfarin']","['creatinine clearance and clinically relevant bleeding', 'percentage of time in international normalized ratio (INR) control and outcomes', 'creatinine clearance', 'VTE recurrence and clinically relevant bleeding', 'VTE recurrence']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0706648,A stronger relationship between creatinine clearance and clinically relevant bleeding was found in the warfarin arm than in the edoxaban arm (  p   = 0.04).,"[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'van Hout', 'Affiliation': 'Health Economics and Decision Science Division, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hawe', 'Affiliation': 'Data Analytics and Design Strategy Division, RTI-Health Solutions, Manchester, United Kingdom.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Cohen', 'Affiliation': ""Department of Haematology, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}]",TH open : companion journal to thrombosis and haemostasis,['10.1055/s-0040-1716496']
2608,33063096,"Evaluation of the impact of a nurse-led program of patient self-assessment and self-management in axial spondyloarthritis: results of a prospective, multicentre, randomized, controlled trial (COMEDSPA).","OBJECTIVE


To evaluate the impact of a nurse-led program of self-management and self-assessment of disease activity in axial spondyloarthritis.
METHODS


Prospective, randomized, controlled, open, 12-month trial (NCT02374749). Participants were consecutive axial spondyloarthritis patients (according to the rheumatologist) and nurses having participated in a 1-day training meeting. The program included self-management: educational video and specific video of graduated, home-based exercises for patients; and self-assessment: video presenting the rationale of tight monitoring of disease activity with composite scores (Ankylosing Spondylitis Disease activity Score, ASDAS/Bath Ankyslosing Spondylitis Disease Activity Index, BASDAI). The nurse trained patients to collect, calculate and report (monthly) ASDAS/BASDAI. Treatment allocation was by random allocation to this program or a comorbidities assessment (not presented here and considered here as the control group).
RESULTS


A total of 502 patients (250 and 252 in the active and control groups, respectively) were enrolled (age: 46.7 (12.2) years, male gender: 62.7%, disease duration: 13.7 (11.0) years). After the one-year follow-up period, the adherence to the self-assessment program was considered good (i.e. 79% reported scores >6 times). Despite a lack of statistical significance in the primary outcome (e.g. coping) there was a statistically significant difference in favor of this program for the following variables: change in BASDAI, number and duration of the home exercises in the active group, and physical activity (international physical activity score, IPAQ).
CONCLUSION


This study suggests a short-term benefit of a nurse-led program on self-management and self-assessment for disease activity in a young axial spondyloarthritis population in terms of disease activity, exercises and physical activity.",2020,"Despite a lack of statistical significance in the primary outcome (e.g. coping) there was a statistically significant difference in favor of this program for the following variables: change in BASDAI, number and duration of the home exercises in the active group, and physical activity (international physical activity score, IPAQ).
","['Participants were consecutive axial spondyloarthritis patients (according to the rheumatologist) and nurses having participated in a 1-day training meeting', 'axial spondyloarthritis', '502 patients (250 and 252 in the active and control groups, respectively) were enrolled (age: 46.7 (12.2)\u2009years, male gender: 62.7%, disease duration: 13.7 (11.0)\u2009years']","['nurse-led program', 'nurse-led program of patient self-assessment and self-management', 'self-management: educational video and specific video of graduated, home-based exercises for patients; and self-assessment: video presenting']","['physical activity (international physical activity score, IPAQ', 'BASDAI, number and duration of the home exercises', 'disease activity with composite scores (Ankylosing Spondylitis Disease activity Score, ASDAS/Bath Ankyslosing Spondylitis Disease Activity Index, BASDAI']","[{'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0334889', 'cui_str': 'Rheumatologist'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1998004', 'cui_str': 'Bath ankylosing spondylitis disease activity index'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",502.0,0.0285517,"Despite a lack of statistical significance in the primary outcome (e.g. coping) there was a statistically significant difference in favor of this program for the following variables: change in BASDAI, number and duration of the home exercises in the active group, and physical activity (international physical activity score, IPAQ).
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Molto', 'Affiliation': 'Rheumatology Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Gossec', 'Affiliation': 'Sorbonne Université, IPLESP, INSERM.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Poiraudeau', 'Affiliation': 'Rehabilitation and Physical Medicine Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Claudepierre', 'Affiliation': 'Rheumatology Department, Henri Mondor Hospital, Assistance Publique Hôpitaux de Paris, and Université Paris Est Créteil, EA, 7379 - EpidermE, Créteil.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Soubrier', 'Affiliation': 'Rheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Fayet', 'Affiliation': 'Rheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wendling', 'Affiliation': 'Rheumatology Department, CHRU de BESANCON, University Teaching Hospital, and Université Bourgogne Franche-Comté, EA4266 (EPILAB), Besançon.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gaudin', 'Affiliation': 'Rheumatology Department, CHU Grenoble.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Dernis', 'Affiliation': 'Rheumatology Department, CH Le Mans.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Guis', 'Affiliation': 'Rheumatology Department, CHU Marseille.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pouplin', 'Affiliation': 'Rheumatology Department, CHU Rouen.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Ruyssen-Witrand', 'Affiliation': 'Centre de Rhumatologie, Hôpital Purpan, et Faculté de Médecine, Université Toulouse III, Paul Sabatier University, Inserm UMR1027, Toulouse.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Chales', 'Affiliation': 'Medecine Faculty, Department of Rheumatology, South Hospital, Rennes 1 University, Rennes.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Mariette', 'Affiliation': 'Rheumatology Department, APHP, Bicêtre Hospital, Le Kremlin-Bicetre.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Beauvais', 'Affiliation': 'Rheumatology Department, Saint Antoine Hospital, APHP, Paris.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Combe', 'Affiliation': 'Rheumatology Department, CHU Montpellier, Montpellier University, Montpellier.'}, {'ForeName': 'René-Marc', 'Initials': 'RM', 'LastName': 'Flipo', 'Affiliation': 'Rheumatology Department, CHU Roger Salengro Hospital, University of Lille, Lille.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Richette', 'Affiliation': 'Université Paris Diderot, UFR médicale.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chary-Valckenaere', 'Affiliation': 'Department of Rheumatology, Nancy Hospital, Nancy.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Saraux', 'Affiliation': 'Rheumatology Unit, UMR1227 (Lymphocytes B et Autoimmunité), Université de Brest, Inserm, CHU, Brest, LabEx IGO, Brest.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Sibilia', 'Affiliation': 'Department of Rheumatology, Hautepierre CHU, Fédération de médecine translationnelle, UMR INSERM 1109, Strasbourg.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Schaeverbeke', 'Affiliation': 'Rheumatology Department, Pellegrin Hospital, Bordeaux, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Rheumatology Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa480']
2609,33063154,The Impact of Bariatric Surgery Compared to Medical Therapy on Health-Related Quality of Life in Subjects with Obesity and Type 2 Diabetes Mellitus.,"INTRODUCTION


The adverse implications of obesity extend beyond physical health to include negative impact on quality of life (QoL), mood, and eating habits. While bariatric surgery provides successful weight loss and metabolic benefits, studies describe conflicting results on QoL and mood-related outcomes.
METHODS


Patients (n = 140) with class II/III obesity and T2DM were recruited from 2015 to 2019, and stratified based on medical or surgical treatment. Questionnaires including the Hospital Anxiety and Depression Scale, Euro QoL visual analogue scale (EQ-VAS), and Revised 21-item Three-Factor Eating Questionnaire (TFEQ-R21) were recorded at baseline, 6 months, and 12 months after treatment.
RESULTS


At baseline, the surgical group (n = 55) and medical group (n = 85) had no significant difference in questionnaire outcomes. At 6 and 12 months, EQ-VAS was higher in the surgical group (12 months surgical 82.00 ± 12.64, medical 72.81 ± 16.56, p = 0.001), with greater improvement from baseline. HADS-D scores at 12 months were lower in the surgical group (surgical 2.60 ± 2.88, medical 3.90 ± 3.58, p = 0.025). At 12 months, the surgical group also had better TFEQ-R21 scores, with higher cognitive restraint scores (surgical 19.09 ± 3.00, medical 16.69 ± 3.61, p < 0.001), and lower scores for uncontrolled eating (surgical 14.96 ± 3.87, medical 17.89 ± 5.34, p = 0.001).
CONCLUSION


In the treatment of patients with obesity and T2DM, bariatric surgery resulted in improved QoL outcomes at 12 months compared to medical therapy. This could be related to improvement in weight and metabolic outcomes, and altered gut-brain axis communication. This is the first prospective study assessing the impact of bariatric surgery on health-related QoL in Asia compared against a control group who received medical therapy.",2020,"HADS-D scores at 12 months were lower in the surgical group (surgical 2.60 ± 2.88, medical 3.90 ± 3.58, p = 0.025).","['Subjects with Obesity and Type 2 Diabetes Mellitus', 'patients with obesity and T2DM, bariatric surgery', 'Patients (n\u2009', '140) with class II/III obesity and T2DM were recruited from 2015 to 2019, and stratified based on medical or surgical treatment']","['bariatric surgery', 'medical therapy', 'Bariatric Surgery Compared to Medical Therapy']","['TFEQ-R21 scores', 'questionnaire outcomes', 'QoL outcomes', 'Hospital Anxiety and Depression Scale, Euro QoL visual analogue scale (EQ-VAS), and Revised 21-item Three-Factor Eating Questionnaire (TFEQ-R21', 'HADS-D scores', 'quality of life (QoL), mood, and eating habits', 'weight and metabolic outcomes', 'EQ-VAS', 'Health-Related Quality of Life', 'cognitive restraint scores']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}]",,0.0289758,"HADS-D scores at 12 months were lower in the surgical group (surgical 2.60 ± 2.88, medical 3.90 ± 3.58, p = 0.025).","[{'ForeName': 'Sarah Ying Tse', 'Initials': 'SYT', 'LastName': 'Tan', 'Affiliation': 'Department of Endocrinology, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Kwang Wei', 'Initials': 'KW', 'LastName': 'Tham', 'Affiliation': 'Department of Endocrinology, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Ganguly', 'Affiliation': 'Department of Endocrinology, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Hong Chang', 'Initials': 'HC', 'LastName': 'Tan', 'Affiliation': 'Department of Endocrinology, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Xin', 'Affiliation': 'Health Services Research Unit, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Henry Yuen Foong', 'Initials': 'HYF', 'LastName': 'Lew', 'Affiliation': 'Department of Psychology, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Chin Hong', 'Initials': 'CH', 'LastName': 'Lim', 'Affiliation': 'Department of Upper Gastrointestinal and Bariatric Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'Department of Upper Gastrointestinal and Bariatric Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Kay Yuan', 'Initials': 'KY', 'LastName': 'Chong', 'Affiliation': 'Division of Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Phong Ching', 'Initials': 'PC', 'LastName': 'Lee', 'Affiliation': 'Department of Endocrinology, Singapore General Hospital, Singapore, Singapore. Lee.phong.ching@singhealth.com.sg.'}]",Obesity surgery,['10.1007/s11695-020-05038-6']
2610,33063157,Diminished Counterregulatory Responses to Meal-Induced Hypoglycemia 4 Years After RYGB.,"PURPOSE


Post-bariatric hypoglycemia is a complication of bariatric surgery, especially Roux-en-Y gastric bypass (RYGB). The counterregulatory hormonal and sympathetic neural responses were measured during a previously reported meal test in which 48% had an almost asymptomatic hypoglycemic event.
MATERIALS AND METHODS


Forty-four randomly selected patients 4 years after RYGB. A liquid meal test (MMT) after overnight fasting. Based on the glucose nadir during the MMT, patients were divided in a hypo group (glucose < 3.3 mmol/L) and a non-hypo group (glucose ≥ 3.3 mmol/L). Cortisol, epinephrine, norepinephrine, blood pressure, and heart rate were measured up to 180 min after ingestion of the meal. Incremental areas under the curve (iAUC), peak, and delta hormone responses after the glucose nadir were calculated. Parameters were compared between the hypo and non-hypo groups.
RESULTS


A total of 21/44 (48%) had an almost asymptomatic hypoglycemic event. Cortisol and epinephrine responses in the hypo group were not increased compared to the non-hypo group, and there were no signs of increased sympathetic nerve activity. Peak and delta cortisol were lower in the hypo compared to the non-hypo group. Norepinephrine was higher in the hypo group especially in the time frame 60-120 and 120-180 min after start of the meal.
CONCLUSION


No increase in epinephrine and a lower cortisol response to hypoglycemia were observed compared to normoglycemia during a meal test in patients after RYGB. Norepinephrine levels were higher in the hypo group. These findings may suggest that possible recurrent hypoglycemia after RYGB results in blunting of counterregulatory responses indicative of hypoglycemia-induced autonomic failure.
CLIN TRIAL REGISTER ID


ISRCTN 11738149.",2020,"Cortisol and epinephrine responses in the hypo group were not increased compared to the non-hypo group, and there were no signs of increased sympathetic nerve activity.",['Forty-four randomly selected patients 4\xa0years after RYGB'],"['epinephrine', 'Norepinephrine']","['sympathetic nerve activity', 'Cortisol, epinephrine, norepinephrine, blood pressure, and heart rate', 'Incremental areas under the curve (iAUC), peak, and delta hormone responses', 'counterregulatory hormonal and sympathetic neural responses', 'asymptomatic hypoglycemic event', 'Peak and delta cortisol', 'cortisol response to hypoglycemia', 'Norepinephrine levels', 'Counterregulatory Responses', 'Cortisol and epinephrine responses']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]","[{'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",44.0,0.0168144,"Cortisol and epinephrine responses in the hypo group were not increased compared to the non-hypo group, and there were no signs of increased sympathetic nerve activity.","[{'ForeName': 'Loek J M', 'Initials': 'LJM', 'LastName': 'de Heide', 'Affiliation': 'Center for Obesity North-Netherlands (CON), Medical Center Leeuwarden, H. Dunantweg 2, 8934 AD, Leeuwarden, The Netherlands. l.de.heide@mcl.nl.'}, {'ForeName': 'Merel', 'Initials': 'M', 'LastName': 'van den Broek', 'Affiliation': 'Center for Obesity North-Netherlands (CON), Medical Center Leeuwarden, H. Dunantweg 2, 8934 AD, Leeuwarden, The Netherlands.'}, {'ForeName': 'Gertjan', 'Initials': 'G', 'LastName': 'van Dijk', 'Affiliation': 'GELIFES-Neurobiology, Department of Behavioral Neuroscience, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Marloes', 'Initials': 'M', 'LastName': 'Emous', 'Affiliation': 'Center for Obesity North-Netherlands (CON), Medical Center Leeuwarden, H. Dunantweg 2, 8934 AD, Leeuwarden, The Netherlands.'}, {'ForeName': 'André P', 'Initials': 'AP', 'LastName': 'van Beek', 'Affiliation': 'Department of Endocrinology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}]",Obesity surgery,['10.1007/s11695-020-05035-9']
2611,33063323,"Lost in translation: True Clinical Impact of RCM Overlooked in ""Biopsy outperforms Reflectance Confocal Microscopy in Diagnosing and Subtyping Basal Cell Carcinoma: Results and Experiences from a Randomized Controlled Multicentre Trial"": reply from authors.","First, we would like to thank M. Gill and colleagues for their interest shown in our study. 1,2  We agree on the importance to determine the place of reflectance confocal microscopy (RCM) as a diagnostic tool in real-world clinical practice, which is why we originally initiated our study. We chose to include patients with clinically suspected primary basal cell carcinoma (BCC), in which dermatoscopic evaluation was usually performed as well, as part of daily clinical practice examination (as also mentioned by the authors as current standard by many worldwide).",2020,"We agree on the importance to determine the place of reflectance confocal microscopy (RCM) as a diagnostic tool in real-world clinical practice, which is why we originally initiated our study.","['1,2', 'patients with clinically suspected primary basal cell carcinoma (BCC']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007117', 'cui_str': 'Basal cell carcinoma'}, {'cui': 'C4721806', 'cui_str': 'Basal cell carcinoma of skin'}]",[],[],,0.0346012,"We agree on the importance to determine the place of reflectance confocal microscopy (RCM) as a diagnostic tool in real-world clinical practice, which is why we originally initiated our study.","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Woliner-van der Weg', 'Affiliation': 'Department of Dermatology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peppelman', 'Affiliation': 'Department of Dermatology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'P E J', 'Initials': 'PEJ', 'LastName': 'van Erp', 'Affiliation': 'Department of Dermatology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'S F K', 'Initials': 'SFK', 'LastName': 'Lubeek', 'Affiliation': 'Department of Dermatology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}]",The British journal of dermatology,['10.1111/bjd.19605']
2612,33063397,Differential effects of visually induced analgesia and attention depending on the pain stimulation site.,"BACKGROUND


The term 'visually induced analgesia' describes a reduced pain perception induced by watching the painful body part as opposed to watching a neutral object. In chronic back pain patients, experimental pain, movement-induced pain and habitual pain can be reduced with visual feedback. Visual feedback can also enhance the effects of both massage treatment and manual therapy. The impact of somatosensory attentional processes remains unclear.
METHODS


In the current study, participants received painful electrical stimuli to their thumb and back while being presented with either a real-time video of their thumb or back (factor feedback). In addition, using an oddball paradigm, they had to count the number of deviant stimuli, applied to either their back or thumb (factor attention) and rate the pain intensity.
RESULTS


We found a significant main effect for attention with decreased pain ratings during attention. There was no main effect for visual feedback and no significant interaction between visual feedback and attention. Post hoc tests revealed that the lowest pain intensity ratings were achieved during visual feedback of the back / thumb and counting at the back / thumb.
CONCLUSION


These data suggest that the modulation of perceived acute pain by visually induced analgesia may be influenced by a simultaneous somatosensory attention task.
SIGNIFICANCE


Somatosensory attention reduced experimental pain intensity in the thumb and back in the presence of both congruent and incongruent visual feedback. We found no significant visual feedback effect on the complex interplay between visual feedback and somatosensory attention.",2020,"In chronic back pain patients, experimental pain, movement-induced pain and habitual pain can be reduced with visual feedback.",[],['painful electrical stimuli to their thumb and back while being presented with either a real-time video of their thumb or back (factor feedback'],"['pain ratings', 'visual feedback effect', 'experimental pain intensity', 'experimental pain, movement-induced pain and habitual pain', 'lowest pain intensity ratings', 'visual feedback', 'pain perception']",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0004600', 'cui_str': 'Back'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",,0.0417368,"In chronic back pain patients, experimental pain, movement-induced pain and habitual pain can be reduced with visual feedback.","[{'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Cordier', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, LWL University Hospital, Ruhr University Bochum, Alexandrinenstraße 1-3, 44791, Bochum, Germany.'}, {'ForeName': 'Eva Marie', 'Initials': 'EM', 'LastName': 'Ullrich', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, LWL University Hospital, Ruhr University Bochum, Alexandrinenstraße 1-3, 44791, Bochum, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Herpertz', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, LWL University Hospital, Ruhr University Bochum, Alexandrinenstraße 1-3, 44791, Bochum, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Zieglgänsberger', 'Affiliation': 'Department of Clinical Neuropharmacology, Max Planck Institute of Psychiatry, Kraepelinstr. 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Trojan', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, LWL University Hospital, Ruhr University Bochum, Alexandrinenstraße 1-3, 44791, Bochum, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Diers', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, LWL University Hospital, Ruhr University Bochum, Alexandrinenstraße 1-3, 44791, Bochum, Germany.'}]","European journal of pain (London, England)",['10.1002/ejp.1676']
2613,33063412,Telemonitoring in patients with chronic heart failure and moderate depressed symptoms - results of the Telemedical Interventional Monitoring in Heart Failure (TIM-HF) study.,"BACKGROUND


Depression is a frequent comorbidity in patients with chronic heart failure (CHF). Telemonitoring has emerged as a novel option in CHF care. However, patients with depression were excluded in most telemedicine studies.
AIMS


This prespecified subgroup-analysis of the Telemedical Interventional Monitoring in Heart Failure (TIM-HF) trial investigates the effect on depressive symptoms over a period of 12 months.
METHODS


The TIM-HF study randomly assigned 710 patients with CHF to either usual care (UC) or a telemedical intervention (TM) using non-invasive devices for daily monitoring electrocardiogram, blood pressure and body weight. Depression was evaluated by the Patient Health Questionnaire (PHQ-9) with scores ≥10 defining clinically relevant depressive symptoms. Mixed model repeated measures were performed to calculate changes in PHQ-9 score. Quality of life (Qol) was measured by the Short Form-36 (SF-36).
RESULTS


At baseline, 156 patients had a PHQ-9 score ≥10 points (TM: 79, UC: 77) with a mean of 13.2 points indicating moderate depressiveness. Patients randomized to telemedicine showed an improvement of their PHQ-9 scores, whereas UC patients remained constant (p=0.004). Qol parameters were improved in the TM group compared to UC. Adjustment was performed for follow-up, NYHA class, medication, age, current living status, number of hospitalizations within last 12 months and serum creatinine. In the study population without depression the PHQ-9 score was similar at baseline and follow-up.
CONCLUSION


Telemedical care improved depressive symptoms and had a positive influence on quality of life in patients with CHF and moderate depression.",2020,"CONCLUSION


Telemedical care improved depressive symptoms and had a positive influence on quality of life in patients with CHF and moderate depression.","['patients with CHF and moderate depression', 'patients with depression', 'patients with chronic heart failure and moderate depressed symptoms - results of the Telemedical Interventional Monitoring in Heart Failure (TIM-HF) study', '710 patients with', '156 patients had a PHQ-9 score ≥10 points (TM: 79, UC: 77) with a mean of 13.2 points indicating moderate depressiveness', 'patients with chronic heart failure (CHF']","['telemedicine', 'CHF to either usual care (UC) or a telemedical intervention (TM) using non-invasive devices', 'Telemonitoring']","['Depression', 'Patient Health Questionnaire (PHQ-9', 'Qol parameters', 'depressive symptoms', 'PHQ-9 scores', 'PHQ-9 score', 'quality of life', 'Quality of life (Qol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",710.0,0.0704058,"CONCLUSION


Telemedical care improved depressive symptoms and had a positive influence on quality of life in patients with CHF and moderate depression.","[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Koehler', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Medical Department, Division of Cardiology and Angiology, Centre for Cardiovascular Telemedicine.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stengel', 'Affiliation': 'Charité Center for Internal Medicine and Dermatology, Department for Psychosomatic Medicine; Charité - Universitätsmedizin Berlin, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Hofmann', 'Affiliation': 'Charité Center for Internal Medicine and Dermatology, Department for Psychosomatic Medicine; Charité - Universitätsmedizin Berlin, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Koehler', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Medical Department, Division of Cardiology and Angiology, Centre for Cardiovascular Telemedicine.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Sehner', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Rose', 'Affiliation': 'Charité Center for Internal Medicine and Dermatology, Department for Psychosomatic Medicine; Charité - Universitätsmedizin Berlin, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Deckwart', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Medical Department, Division of Cardiology and Angiology, Centre for Cardiovascular Telemedicine.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) partner site Berlin; Charité Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Koehler', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Medical Department, Division of Cardiology and Angiology, Centre for Cardiovascular Telemedicine.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Leipzig, Germany.'}]",European journal of heart failure,['10.1002/ejhf.2025']
2614,33063439,Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a secondary analysis of the PITCHES trial.,"OBJECTIVE


To evaluate whether a particular group of women with intrahepatic cholestasis of pregnancy (ICP), based on their presenting characteristics, would benefit from treatment with ursodeoxycholic acid (UDCA).
DESIGN


Secondary analysis of the PITCHES trial (ISRCTN91918806).
SETTING


United Kingdom.
POPULATION OR SAMPLE


527 women with ICP.
METHODS


Subgroup analyses were performed to determine whether baseline bile acid concentrations or baseline itch scores moderated a woman's response to treatment with UDCA.
MAIN OUTCOME MEASURES


Bile acid concentration and itch score.
RESULTS


In women with baseline bile acid concentrations less than 40 μmol/L, treatment with UDCA resulted in increased post-randomisation bile acid concentrations (geometric mean ratio 1.19, 95% CI 1.00 to 1.41, p = 0.048). A test of interaction showed no significance (p = 0.647). A small, clinically insignificant difference was seen in itch response in women with a high baseline itch score (-6.0 mm, 95% CI -11.80 to -0.21, p = 0.042), with a test of interaction not showing significance (p = 0.640). Further subgroup analyses showed no significance. Across all women there was a weak relationship between bile acid concentrations and itch severity.
CONCLUSIONS


There was no subgroup of women with ICP in whom a beneficial effect of treatment with UDCA on bile acid concentration or itch score could be identified. This confirms that its routine use in women with this condition for improvement of bile acid concentration or itch score should be reconsidered.",2020,"In women with baseline bile acid concentrations less than 40 μmol/L, treatment with UDCA resulted in increased post-randomisation bile acid concentrations (geometric mean ratio 1.19, 95% CI 1.00 to 1.41, p = 0.048).","['527 women with ICP', 'women with intrahepatic cholestasis of pregnancy (ICP', 'intrahepatic cholestasis of pregnancy', 'United Kingdom']","['ursodeoxycholic acid (UDCA', 'Ursodeoxycholic acid', 'UDCA']","['itch response', 'bile acid concentration or itch score', 'Bile acid concentration and itch score', 'bile acid concentrations and itch severity', 'post-randomisation bile acid concentrations']","[{'cui': 'C4517805', 'cui_str': '527'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0268318', 'cui_str': 'Cholestasis of pregnancy'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}]","[{'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",527.0,0.470972,"In women with baseline bile acid concentrations less than 40 μmol/L, treatment with UDCA resulted in increased post-randomisation bile acid concentrations (geometric mean ratio 1.19, 95% CI 1.00 to 1.41, p = 0.048).","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Fleminger', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': 'National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Dixon', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Chambers', 'Affiliation': 'ICP Support, Sutton Coldfield, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Dorling', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, IWK Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Williamson', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Jim G', 'Initials': 'JG', 'LastName': 'Thornton', 'Affiliation': 'Division of Child Health, Obstetrics and Gynaecology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16567']
2615,33050321,Brief Hospital Supervision of Exercise and Diet During Adjuvant Breast Cancer Therapy Is Not Enough to Relieve Fatigue: A Multicenter Randomized Controlled Trial.,"Supervised exercise dietary programs are recommended to relieve cancer-related fatigue and weight increase induced by adjuvant treatment of early breast cancer (EBC). As this recommendation lacks a high level of evidence, we designed a multicenter randomized trial to evaluate the impact of an Adapted Physical Activity Diet (APAD) education program on fatigue. We randomized 360 women with EBC who were receiving adjuvant chemotherapy and radiotherapy to APAD or usual care at eight French cancer institutions. Data were collected at baseline, end of chemotherapy, end of radiotherapy, and 6 months post-treatment. The primary endpoint was the general cancer-related fatigue score using the MFI-20 questionnaire. Fatigue correlated with the level of precariousness, but we found no significant difference between the two groups in terms of general fatigue ( p  = 0.274). The APAD arm has a smaller proportion of patients with confirmed depression at the end of follow-up ( p  = 0.052). A transient modification in physical activity levels and dietary intake was reported in the experimental arm. However, a mixed hospital- and home-based APAD education program is not enough to improve fatigue caused by adjuvant treatment of EBC. Cancer care centers should consider integrating more proactive diet-exercise supportive care in this population, focusing on precarious patients.",2020,"Fatigue correlated with the level of precariousness, but we found no significant difference between the two groups in terms of general fatigue ( p  = 0.274).","['Cancer care centers', 'or usual care at eight French cancer institutions', '360 women with EBC who were receiving']","['Exercise and Diet', 'Supervised exercise dietary programs', 'Adapted Physical Activity Diet (APAD) education program', 'adjuvant chemotherapy and radiotherapy to APAD']","['general fatigue', 'fatigue', 'physical activity levels and dietary intake', 'general cancer-related fatigue score using the MFI-20 questionnaire', 'Fatigue']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",360.0,0.0467317,"Fatigue correlated with the level of precariousness, but we found no significant difference between the two groups in terms of general fatigue ( p  = 0.274).","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Jacot', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Arnaud', 'Affiliation': 'Sainte-Catherine Institute, 1750 Chemin Lavarin, 84000 Avignon, France.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Jarlier', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lefeuvre-Plesse', 'Affiliation': 'Eugène Marquis Center, Rue de la Bataille Flandres-Dunkerque, CS 44229, 35042 Rennes, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Dalivoust', 'Affiliation': ""Ambroise Paré Hospital, 1 Rue de l'Eylau, 13006 Marseille, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Senesse', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Azzedine', 'Affiliation': 'Montélimar Hospital, Quartier Beausseret, BP 249-26, 26216 Montélimar, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Tredan', 'Affiliation': 'Léon Bérard Center, 28 Rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Sadot-Lebouvier', 'Affiliation': 'René Gauducheau Center, Boulevard Jacques Monod, 44805 Saint-Herblain, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Mas', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Carayol', 'Affiliation': 'IAPS Laboratory ""Impact of Physical Activity on Health"", University of Toulon, Avenue de l\'Université, 83957 La Garde, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Bleuse', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Gourgou', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Janiszewski', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Silene', 'Initials': 'S', 'LastName': 'Launay', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': ""D'Hondt"", 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Lauridant', 'Affiliation': 'Oscar Lambret Center, 3 Rue Frédéric Combemale, 59000 Lille, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Grenier', 'Affiliation': 'Sainte-Catherine Institute, 1750 Chemin Lavarin, 84000 Avignon, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Romieu', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Ninot', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Vanlemmens', 'Affiliation': 'Oscar Lambret Center, 3 Rue Frédéric Combemale, 59000 Lille, France.'}]",Nutrients,['10.3390/nu12103081']
2616,33050325,Non-Surgical Periodontal Therapy with Adjunctive Amoxicillin/Metronidazole or Metronidazole When No  Aggregatibacter actinomycetemcomitans  Is Detected-A Randomized Clinical Trial.,"BACKGROUND


The aim was to compare two different systemic antibiotics regimens adjunctive to non-surgical periodontal therapy when  Aggregatibacter actinomycetemcomitans  was not detected in the subgingival biofilm.
METHODS


A total of 58 patients with periodontitis and with no  A. actinomycetemcomitans  in the subgingival biofilm were treated with full-mouth subgingival instrumentation and either metronidazole (MET;  n  = 29) or amoxicillin/metronidazole (AMX/MET;  n  = 29). Probing depth (PD), clinical attachment level (CAL) and bleeding on probing (BOP) were recorded at baseline, as well as after three and six months. Subgingival biofilm and gingival crevicular fluid were collected and analyzed for major periodontopathogens and biomarkers.
RESULTS


PD, CAL and BOP improved at 3 and 6 months (each  p  < 0.001 vs. baseline) with no difference between the groups. Sites with initial PD ≥ 6 mm also improved in both groups after 3 and 6 months ( p  < 0.001) with a higher reduction of PD in the AMX/MET group ( p  < 0.05). T. forsythia was lower in the AMX/MET group after 3 months ( p  < 0.05). MMP-8 and IL-1β were without significant changes and differences between the groups.
CONCLUSION


When  A. actinomycetemcomitans  was not detected in the subgingival biofilm, the adjunctive systemic use of amoxicillin/metronidazole results in better clinical and microbiological outcomes of non-surgical periodontal therapy when the application of systemic antibiotics is scheduled.",2020,T. forsythia was lower in the AMX/MET group after 3 months ( p  < 0.05).,['58 patients with periodontitis and with no  A. actinomycetemcomitans  in the subgingival biofilm'],"['amoxicillin/metronidazole', 'Amoxicillin/Metronidazole or Metronidazole', 'amoxicillin/metronidazole (AMX/MET', 'metronidazole']","['MMP-8 and IL-1β', 'Probing depth (PD), clinical attachment level (CAL) and bleeding on probing (BOP', 'T. forsythia', 'PD, CAL and BOP', 'Subgingival biofilm and gingival crevicular fluid']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}]","[{'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C1018538', 'cui_str': 'Lian qiao'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}]",58.0,0.0764114,T. forsythia was lower in the AMX/MET group after 3 months ( p  < 0.05).,"[{'ForeName': 'Holger F R', 'Initials': 'HFR', 'LastName': 'Jentsch', 'Affiliation': 'Centre for Periodontology, Department of Cariology, Endodontology and Periodontology, University Hospital of Leipzig, Liebigstr. 12, Haus 1, D-04103 Leipzig, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dietrich', 'Affiliation': 'Private Dental Practice, Borngasse 12, D-99084 Erfurt, Germany.'}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Eick', 'Affiliation': 'Department of Periodontology, Laboratory of Oral Microbiology, School of Dental Medicine, University of Bern, Freiburgstr. 7, CH-3010 Bern, Switzerland.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9100686']
2617,33050340,Feasibility and Safety of Transcranial Direct Current Stimulation in an Outpatient Rehabilitation Setting After Stroke.,"Transcranial direct current stimulation (tDCS) has strong potential for outpatient clinical use, but feasibility and safety of tDCS has only been evaluated in laboratory and inpatient clinical settings. The objective of this study was to assess feasibility and safety of tDCS for stroke in an outpatient clinical setting. Individuals with stroke in outpatient therapy received tDCS during physical therapy sessions. Feasibility was assessed with screening, enrollment, withdrawal, and adherence numbers, tDCS impressions, and perceived benefits and detriments of tDCS. Acute changes in fatigue and self-reported function and pre-post changes in fatigue were also assessed. Safety was assessed as adverse events and side effects. In total, 85 individuals were screened, and 10 were enrolled. Most exclusions were unrelated to clinical feasibility. In total, 3 participants withdrew, so 7 participants completed 2 sessions/week for 5-6 weeks with 100% adherence. In total, 71% reported positive impressions of tDCS. tDCS setup decreased to 5-7 min at end of study. There was one adverse event unrelated to tDCS. Mild to moderate side effects (tingling, itching, pinching, and fatigue) were experienced. In total, 86% of participants recounted benefits of tDCS. There were acute improvements in function and energy. Results support the feasibility and safety of tDCS in an outpatient clinical setting.",2020,There was one adverse event unrelated to tDCS.,"['Individuals with stroke in outpatient therapy received tDCS during physical therapy sessions', '85 individuals were screened, and 10 were enrolled', 'Outpatient Rehabilitation Setting After Stroke']","['Transcranial direct current stimulation (tDCS', 'Transcranial Direct Current Stimulation', 'tDCS']","['screening, enrollment, withdrawal, and adherence numbers, tDCS impressions, and perceived benefits and detriments of tDCS', 'positive impressions of tDCS', 'tDCS setup', 'Mild to moderate side effects (tingling, itching, pinching, and fatigue', 'fatigue and self-reported function and pre-post changes in fatigue', 'feasibility and safety', 'function and energy', 'adverse events and side effects']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0418416', 'cui_str': 'Pinched'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",85.0,0.0441035,There was one adverse event unrelated to tDCS.,"[{'ForeName': 'Brice T', 'Initials': 'BT', 'LastName': 'Cleland', 'Affiliation': 'Brain Plasticity Lab, Department of Physical Therapy, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Galick', 'Affiliation': 'Shirley Ryan AbilityLab DayRehab Center, Homewood, IL 60430, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Huckstep', 'Affiliation': 'Shirley Ryan AbilityLab DayRehab Center, Homewood, IL 60430, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lenhart', 'Affiliation': 'Shirley Ryan AbilityLab DayRehab Center, Homewood, IL 60430, USA.'}, {'ForeName': 'Sangeetha', 'Initials': 'S', 'LastName': 'Madhavan', 'Affiliation': 'Brain Plasticity Lab, Department of Physical Therapy, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL 60612, USA.'}]",Brain sciences,['10.3390/brainsci10100719']
2618,33050362,"Effects of Hyperbaric Oxygen Therapy on Inflammation, Oxidative/Antioxidant Balance, and Muscle Damage after Acute Exercise in Normobaric, Normoxic and Hypobaric, Hypoxic Environments: A Pilot Study.","The purpose of this study was to investigate the effects of hyperbaric oxygen therapy (HBOT) on inflammation, the oxidative/antioxidant balance, and muscle damage after acute exercise in normobaric, normoxic (NN) and hypobaric, hypoxic (HH) environments. Eighteen healthy males were selected and randomly assigned to three groups: exercise in NN conditions (NN group,  n  = 6), HBOT treatment after exercise in NN conditions (HNN group,  n  = 6), and HBOT treatment after exercise in HH conditions (HHH group,  n  = 6). All subjects performed treadmill running for 60 min at 75-80% maximum heart rate (HRmax) exercise intensity under each condition. The HBOT treatments consisted of breathing 100% oxygen at 2.5 atmosphere absolute (ATA) for 60 min. Blood samples were collected before exercise (BE), after exercise (AE), and after HBOT (AH) to examine inflammation (fibrinogen, interleukin-6 [IL-6], and tumor necrosis factor-α (TNF-α)), the oxidative/antioxidant balance (derivatives of reactive oxygen metabolites (d-ROMs) and the biological antioxidant potential (BAP)), and muscle damage (creatine kinase (CK) and lactate dehydrogenase (LDH)). Plasma fibrinogen, serum IL-6, CK, and LDH levels were significantly increased AE compared to BE in all groups ( p  < 0.05). Plasma fibrinogen levels were significantly decreased AH compared to AE in all groups ( p  < 0.05), and the HNN group had a significantly lower AH compared to BE ( p  < 0.05). Serum IL-6 levels were significantly decreased AH compared to AE in the HNN and HHH groups ( p  < 0.05). Serum CK levels were significantly decreased AH compared to AE in the HHH group ( p  < 0.05). Serum LDH levels were significantly decreased AH compared to AE in the HNN and HHH groups ( p  < 0.05), and the NN and HNN groups had significantly higher AH serum LDH levels compared to BE ( p  < 0.05). These results suggest that acute exercise in both the NN and HH environments could induce temporary inflammatory responses and muscle damage, whereas HBOT treatment may be effective in alleviating exercise-induced inflammatory responses and muscle damage.",2020,"Plasma fibrinogen, serum IL-6, CK, and LDH levels were significantly increased AE compared to BE in all groups ( p  < 0.05).",['Eighteen healthy males'],"['exercise in NN conditions (NN group,  n  = 6), HBOT treatment after exercise in NN conditions (HNN group,  n  = 6), and HBOT treatment after exercise in HH conditions (HHH group,  n  = 6', 'Hyperbaric Oxygen Therapy', 'treadmill running for 60 min at 75-80% maximum heart rate (HRmax) exercise intensity under each condition', 'hyperbaric oxygen therapy (HBOT']","['Serum IL-6 levels', 'AH serum LDH levels', 'Plasma fibrinogen, serum IL-6, CK, and LDH levels', 'Inflammation, Oxidative/Antioxidant Balance, and Muscle Damage', 'inflammation, the oxidative/antioxidant balance, and muscle damage after acute exercise in normobaric, normoxic (NN) and hypobaric, hypoxic (HH) environments', 'Serum LDH levels', 'inflammation (fibrinogen, interleukin-6 [IL-6], and tumor necrosis factor-α (TNF-α)), the oxidative/antioxidant balance (derivatives of reactive oxygen metabolites (d-ROMs) and the biological antioxidant potential (BAP)), and muscle damage (creatine kinase (CK) and lactate dehydrogenase (LDH', 'Serum CK levels', 'Plasma fibrinogen levels']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0268540', 'cui_str': 'Hyperornithinemia-hyperammonemia-homocitrullinuria syndrome'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0856510', 'cui_str': 'Plasma fibrinogen'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C4049351', 'cui_str': 'Biological antioxidant potential'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}]",18.0,0.0181581,"Plasma fibrinogen, serum IL-6, CK, and LDH levels were significantly increased AE compared to BE in all groups ( p  < 0.05).","[{'ForeName': 'Jinhee', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Department of Physical Education, College of Arts and Physical Education, Dong-A University, Busan 49315, Korea.'}, {'ForeName': 'Jae-Hee', 'Initials': 'JH', 'LastName': 'Min', 'Affiliation': 'Department of Physical Education, College of Arts and Physical Education, Dong-A University, Busan 49315, Korea.'}, {'ForeName': 'Yul-Hyo', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Taekwondo, Youngsan University, Yangsan-si 50510, Korea.'}, {'ForeName': 'Hee-Tae', 'Initials': 'HT', 'LastName': 'Roh', 'Affiliation': 'Department of Physical Education, College of Arts and Physical Education, Dong-A University, Busan 49315, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17207377']
2619,33050401,Telephone-Delivered Dietary Intervention in Patients with Age-Related Macular Degeneration: 3-Month Post-Intervention Findings of a Randomised Controlled Trial.,"There is an evidence-practice gap between the dietary recommendations for age-related macular degeneration (AMD) presented in the literature and those practiced by patients. This study reports on the 3-month post-intervention results of a randomised controlled trial (RCT) evaluating telephone-delivered counselling to improve dietary behaviours among AMD patients. A total of 155 AMD patients (57% female, aged 78 ± 8 years; control: 78, intervention: 77), primarily residing in New South Wales, Australia, were recruited. Participants completed a baseline questionnaire and a short dietary questionnaire (SDQ-AMD). The intervention included an evidence-based nutrition resource and four monthly calls with a dietitian. Immediately post-intervention, intervention participants repeated the SDQ-AMD and completed a feedback form. At 3 months post-intervention, both study arms repeated the SDQ-AMD. Statistical analyses included  t -tests and McNemar's test. Intervention participants reported satisfaction with the tailored phone calls, nutrition resource and nutrition education provided. At 3 months post-intervention, there was no statistically significant difference between study arms in the proportion of participants meeting the dietary goals nor in intake (mean servings ± SE) of total vegetables (primary outcome) and other key food groups; however, there was a significantly higher intake of nuts (secondary outcome) (3.96 ± 0.51 vs. 2.71 ± 0.32;  p  = 0.04) among participants in the intervention versus control group. Within the intervention arm, there were also significant improvements in intakes of the following secondary outcomes: dark green leafy vegetables (0.99 ± 0.17 vs. 1.71 ± 0.22;  p  = 0.003) and legumes (0.69 ± 0.10 vs. 1.12 ± 0.16;  p  = 0.02) and intake of sweets and processed/prepared foods (8.31 ± 0.76 vs. 6.54 ± 0.58,  p  = 0.01). In summary, although there were few dietary differences between study arms at 3 months post-intervention, the intervention involving four monthly calls was acceptable and helpful to the participants. This type of intervention therefore has the potential to provide people with AMD the needed support for improving their nutrition knowledge and dietary practices, especially if continued over a longer period.",2020,"Within the intervention arm, there were also significant improvements in intakes of the following secondary outcomes: dark green leafy vegetables (0.99 ± 0.17 vs. 1.71 ± 0.22;  p  = 0.003) and legumes (0.69 ± 0.10 vs. 1.12 ± 0.16;  p  = 0.02) and intake of sweets and processed/prepared foods (8.31 ± 0.76 vs. 6.54 ± 0.58,  p  = 0.01).","['Patients with Age-Related Macular Degeneration', '155 AMD patients (57% female, aged 78 ± 8 years; control: 78, intervention: 77), primarily residing in New South Wales, Australia, were recruited', 'AMD patients']","['evidence-based nutrition resource and four monthly calls with a dietitian', 'telephone-delivered counselling', 'Telephone-Delivered Dietary Intervention']","['dietary behaviours', 'intakes of the following secondary outcomes: dark green leafy vegetables', 'dietary goals nor in intake (mean servings ± SE) of total vegetables', 'intake of sweets', 'baseline questionnaire and a short dietary questionnaire (SDQ-AMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C2348897', 'cui_str': 'Green leafy vegetable'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}]",155.0,0.0497649,"Within the intervention arm, there were also significant improvements in intakes of the following secondary outcomes: dark green leafy vegetables (0.99 ± 0.17 vs. 1.71 ± 0.22;  p  = 0.003) and legumes (0.69 ± 0.10 vs. 1.12 ± 0.16;  p  = 0.02) and intake of sweets and processed/prepared foods (8.31 ± 0.76 vs. 6.54 ± 0.58,  p  = 0.01).","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Tang', 'Affiliation': 'Centre for Vision Research, Department of Ophthalmology and Westmead Institute for Medical Research, University of Sydney, Camperdown, NSW 2006, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mitchell', 'Affiliation': 'Centre for Vision Research, Department of Ophthalmology and Westmead Institute for Medical Research, University of Sydney, Camperdown, NSW 2006, Australia.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Liew', 'Affiliation': 'Centre for Vision Research, Department of Ophthalmology and Westmead Institute for Medical Research, University of Sydney, Camperdown, NSW 2006, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Burlutsky', 'Affiliation': 'Centre for Vision Research, Department of Ophthalmology and Westmead Institute for Medical Research, University of Sydney, Camperdown, NSW 2006, Australia.'}, {'ForeName': 'Victoria M', 'Initials': 'VM', 'LastName': 'Flood', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Camperdown, NSW 2006, Australia.'}, {'ForeName': 'Bamini', 'Initials': 'B', 'LastName': 'Gopinath', 'Affiliation': 'Centre for Vision Research, Department of Ophthalmology and Westmead Institute for Medical Research, University of Sydney, Camperdown, NSW 2006, Australia.'}]",Nutrients,['10.3390/nu12103083']
2620,32936838,Emergence of genotype C1 Enterovirus A71 and its link with antigenic variation of virus in Taiwan.,"An outbreak of the hand-foot-mouth disease with severe neurological cases, mainly caused by the genotype C1 enterovirus A71 (EV-A71), occurred in Taiwan between 2018 and early 2019. In the recent decade, the most dominant EV-A71 genotypes in Taiwan were B5 and C4 but changed to C1 in 2018. Antibody-mediated immunity plays a key role in limiting the EV-A71 illness in humans. However, the level of neutralizing activities against genotype C1 virus by human polyclonal and monoclonal antibodies (MAbs) remains largely unclear. In the study, we demonstrated that that 39% (9 in 23) of post-infection sera from the genotype B5- or C4-infected patients in 2014-2017 exhibit reduced titers with the 2018-2019 genotype C1 viruses than with the earlier B5 and C4 viruses tested. This finding with polyclonal sera is confirmed with human MAbs derived from genotype B5 virus-infected individuals. The 2018-2019 genotype C1 virus is resistant to the majority of canyon-targeting human MAbs, which may be associated with the residue change near or at the bottom of the canyon region on the viral capsid. The remaining three antibodies (16-2-11B, 16-3-4D, and 17-1-12A), which target VP1 S241 on the 5-fold vertex, VP3 E81 on the 3-fold plateau and VP2 D84 on the 2-fold plateau of genotype C1 viral capsid, respectively, retained neutralizing activities with variable potencies. These neutralizing antibodies were also found to be protective against a lethal challenge of the 2018-2019 genotype C1 virus in an hSCARB2-transgenic mice model. These results indicate that the EV-A71-specific antibody response may consist of a fraction of poorly neutralizing antibodies against 2018-2019 genotype C1 viruses among a subset of previously infected individuals. Epitope mapping of protective antibodies that recognize the emerging genotype C1 virus has implications for anti-EV-A71 MAbs and the vaccine field.",2020,These neutralizing antibodies were also found to be protective against a lethal challenge of the 2018-2019 genotype C1 virus in an hSCARB2-transgenic mice model.,['virus in Taiwan'],[],[],"[{'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]",[],[],,0.0160479,These neutralizing antibodies were also found to be protective against a lethal challenge of the 2018-2019 genotype C1 virus in an hSCARB2-transgenic mice model.,"[{'ForeName': 'Kuan-Ying A', 'Initials': 'KA', 'LastName': 'Huang', 'Affiliation': 'Division of Pediatric Infectious Diseases, Department of Pediatrics, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Peng-Nien', 'Initials': 'PN', 'LastName': 'Huang', 'Affiliation': 'Research Center for Emerging Viral Infections, College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Yhu-Chering', 'Initials': 'YC', 'LastName': 'Huang', 'Affiliation': 'Division of Pediatric Infectious Diseases, Department of Pediatrics, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Shu-Li', 'Initials': 'SL', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Biotechnology and Laboratory Science, College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Kuo-Chien', 'Initials': 'KC', 'LastName': 'Tsao', 'Affiliation': 'Department of Medical Biotechnology and Laboratory Science, College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Cheng-Hsun', 'Initials': 'CH', 'LastName': 'Chiu', 'Affiliation': 'Division of Pediatric Infectious Diseases, Department of Pediatrics, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Shin-Ru', 'Initials': 'SR', 'LastName': 'Shih', 'Affiliation': 'Research Center for Emerging Viral Infections, College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Tzou-Yien', 'Initials': 'TY', 'LastName': 'Lin', 'Affiliation': 'Division of Pediatric Infectious Diseases, Department of Pediatrics, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}]",PLoS pathogens,['10.1371/journal.ppat.1008857']
2621,32139222,DAPT Score and the Impact of Ticagrelor Monotherapy During the Second Year After PCI.,"OBJECTIVES


This study assessed the ability of the dual-antiplatelet therapy (DAPT) score in stratifying ischemic and bleeding risk in a contemporary percutaneous coronary intervention (PCI) population.
BACKGROUND


The DAPT score is recommended by guidelines as a tool to stratify ischemic and bleeding risk. Its utility in contemporary PCI is unknown.
METHODS


The study studied patients in GLOBAL LEADERS (A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) who were free of major ischemic and bleeding events and adhered to antiplatelet strategy during the first year after PCI. The primary ischemic endpoint was the composite of myocardial infarction or stent thrombosis. The primary bleeding endpoint was Bleeding Academic Research Consortium type 3 or 5. Outcomes from 12 to 24 months after PCI were compared according to the DAPT score.
RESULTS


Of 11,289 patients that were event-free after the first year, 6,882 and 4,407 patients had low (<2) and high (≥2) DAPT scores, respectively. Compared with a low DAPT score, patients with a high DAPT score had a higher rate of the composites of myocardial infarction or stent thrombosis (0.70% vs. 1.55%; p < 0.0001). The rate of Bleeding Academic Research Consortium type 3 or 5 bleeding was 0.54% and 0.30% in the low and high DAPT score groups, respectively (p = 0.058). The effect of ticagrelor versus aspirin monotherapy on primary ischemic and bleeding endpoints during the second year were no different among the 2 groups.
CONCLUSIONS


The DAPT score can stratify ischemic but not bleeding risk in a contemporary PCI population during the second year. The score did not provide additional value for selection of antiplatelet strategy beyond the first year.",2020,"The effect of ticagrelor versus aspirin monotherapy on primary ischemic and bleeding endpoints during the second year were no different among the 2 groups.
","['11,289 patients that were event-free after the first year', ' 6,882 and 4,407 patients had low (<2) and high (≥2) DAPT scores, respectively']","['dual-antiplatelet therapy (DAPT) score', 'Anti-platelet Therapy', 'ticagrelor', 'Ticagrelor\xa0Monotherapy', 'aspirin monotherapy']","['composite of myocardial infarction or stent thrombosis', 'major ischemic and bleeding events', 'composites of myocardial infarction or stent thrombosis', 'primary ischemic and bleeding endpoints', 'DAPT Score', 'rate of Bleeding Academic Research Consortium type 3 or 5 bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}]",11289.0,0.0347917,"The effect of ticagrelor versus aspirin monotherapy on primary ischemic and bleeding endpoints during the second year were no different among the 2 groups.
","[{'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Heart Center, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands; Cardiology Unit, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Heart Center, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands; Department of Internal Medicine, Cardiology Division, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Heart Center, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Heart Center, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Heart Center, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Chun-Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Interventional Cardiology, Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Interventional Cardiology, Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands; First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Heart Center, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Walsh', 'Affiliation': 'Department of Cardiology, Belfast Health and Social Care Trust, Belfast, United Kingdom.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Suryapranata', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cotton', 'Affiliation': 'Department of Cardiology, Heart and Lung Centre, New Cross Hospital, Wolverhampton, United Kingdom.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Koning', 'Affiliation': 'Cardiology Service, Clinique Saint-Hilaire, Rouen, France.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Akin', 'Affiliation': 'First Department of Medicine, University Medical Centre Mannheim, Faculty of Medicine Mannheim, University of Heidelberg, European Center for AngioScience and German Center for Cardiovascular Research Partner Site Heidelberg/Mannheim, Mannheim, Germany.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Kukreja', 'Affiliation': 'Department of Cardiology, East and North Hertfordshire NHS Trust, Hertfordshire, United Kingdom.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wykrzykowska', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Heart Center, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Heart Center, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Department of Cardiology, East Lancashire Hospitals NHS Trust, Blackburn, Lancashire, United Kingdom.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heart Center, University of Giessen, Bad Nauheim, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'French Alliance for Cardiovascular Trials, INSERM U-1148, Hôpital Bichat, Université Paris-Diderot, Assistance Publique-Hôpitaux de Paris, Paris, France; Imperial College and the Institute of Cardiovascular Medicine and Science, National Heart and Lung Institute, Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway, Galway, Ireland.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway, Galway, Ireland; International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.12.018']
2622,33050671,"Relationship between Perceived Training Load, Well-Being Indices, Recovery State and Physical Enjoyment during Judo-Specific Training.","This study investigated the relationship between well-being indices and the session rating of perceived exertion (session-RPE), recovery (TQR), and physical enjoyment (PE) during intensified, tapering phases of judo training. Sixty-one judo athletes (37 males, ranges 14-17 years, 159-172 cm, 51-67 kg) were randomly assigned to three experimental (i.e., randori, uchi-komi, running) and control groups (regular training). Experimental groups trained four times per week for 4 weeks of intensified training followed by 12 days of tapering. Session-RPE, well-being indices (i.e., sleep, stress, fatigue, delayed onset of muscle soreness (DOMS), Hooper index (HI)), and TQR were measured every session, whereas PE was recorded after intensified, tapering periods. Recovery (TQR) was negatively correlated with sleep, stress, fatigue, DOMS, HI, session-RPE in intensified period and was negatively correlated with sleep, stress, fatigue, DOMS, HI in tapering. Session-RPE was positively correlated with sleep, fatigue, DOMS, HI in intensified period and positively correlated with fatigue, DOMS in tapering. PE was negatively correlated with stress in intensified training. Enjoyment could be partially predicted by sleep only in intensified periods. Session-RPE could be partially predicted by TQR, fatigue during intensified periods and by sleep, and HI during tapering. Sleep, recovery state, pre-fatigue states, and HI are signals contributing to the enjoyment and internal intensity variability during training. Coaches can use these simple tools to monitor judo training.",2020,"Recovery (TQR) was negatively correlated with sleep, stress, fatigue, DOMS, HI, session-RPE in intensified period and was negatively correlated with sleep, stress, fatigue, DOMS, HI in tapering.","['Sixty-one judo athletes (37 males, ranges 14-17 years, 159-172 cm, 51-67 kg']",[],"['sleep, fatigue, DOMS, HI', 'Session-RPE, well-being indices (i.e., sleep, stress, fatigue, delayed onset of muscle soreness (DOMS), Hooper index (HI)), and TQR', 'sleep, stress, fatigue, DOMS, HI, session-RPE', 'Sleep, recovery state, pre-fatigue states, and HI are signals contributing to the enjoyment and internal intensity variability', 'Well-Being Indices, Recovery State and Physical Enjoyment', 'sleep, stress, fatigue, DOMS, HI in tapering', 'PE', 'Recovery (TQR', 'session rating of perceived exertion (session-RPE), recovery (TQR), and physical enjoyment (PE']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0079650', 'cui_str': 'Judo'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517601', 'cui_str': '172'}]",[],"[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013007', 'cui_str': 'Methyldimethoxyamphetamine'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",61.0,0.020412,"Recovery (TQR) was negatively correlated with sleep, stress, fatigue, DOMS, HI, session-RPE in intensified period and was negatively correlated with sleep, stress, fatigue, DOMS, HI in tapering.","[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Ouergui', 'Affiliation': 'High Institute of Sports and Physical Education of Kef, University of Jendouba, Boulifa University Campus, Kef 7100, Tunisia.'}, {'ForeName': 'Emerson', 'Initials': 'E', 'LastName': 'Franchini', 'Affiliation': 'Martial Arts and Combat Sports Research Group, School of Physical Education and Sport, University of São Paulo, 05508-030 São Paulo, Brazil.'}, {'ForeName': 'Okba', 'Initials': 'O', 'LastName': 'Selmi', 'Affiliation': 'High Institute of Sports and Physical Education of Kef, University of Jendouba, Boulifa University Campus, Kef 7100, Tunisia.'}, {'ForeName': 'Danielle Evé', 'Initials': 'DE', 'LastName': 'Levitt', 'Affiliation': 'Applied Physiology Laboratory, Department of Kinesiology, Health Promotion, and Recreation, University of North Texas, Denton, TX 76203, USA.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Chtourou', 'Affiliation': 'High Institute of Sport and Physical Education of Sfax, Université de Sfax, Sfax 3000, Tunisie.'}, {'ForeName': 'Ezdine', 'Initials': 'E', 'LastName': 'Bouhlel', 'Affiliation': 'Laboratory of Cardio-Circulatory, Respiratory, Metabolic and Hormonal Adaptations to Muscular Exercise, Faculty of Medicine Ibn El Jazzar, University of Sousse, Sousse 4000, Tunisia.'}, {'ForeName': 'Luca Paolo', 'Initials': 'LP', 'LastName': 'Ardigò', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, School of Exercise and Sport Science, University of Verona, 37131 Verona, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17207400']
2623,33050719,Multimodal chiropractic care for migraine: A pilot randomized controlled trial.,"BACKGROUND


Spinal manipulation may reduce migraine frequency, but effects of multimodal chiropractic care on migraine frequency have not been evaluated.
METHODS


We conducted a pilot randomized controlled trial comparing multimodal chiropractic care + enhanced usual care (MCC+) versus enhanced usual care alone (EUC) among adult women with episodic migraine. EUC was comprised of usual medical care and migraine education literature. MCC+ participants received 10 sessions of chiropractic care over 14 weeks. Primary aims evaluated feasibility of recruitment, retention, protocol adherence, and safety. Change in migraine days was a secondary aim.
RESULTS


Of 422 patients screened, 61 were randomized over 20 months. Fifty-seven (93%) completed daily migraine logs during the intervention, 51 (84%) completed final follow-up, and 45 (74%) completed all assessments. Twenty-four of 29 MCC+ participants (83%) attended > 75% of the chiropractic sessions. Ninety-eight non-serious adverse events were reported by 26 participants (43%) with 39 events among 11 EUC participants and 59 events among 15 MCC+ participants. MCC+ participants experienced greater reductions in migraine days (-2.9 days for MCC+ vs. -1.0 days for EUC, difference = -1.9; 95% confidence interval: -3.5, -0.4).
CONCLUSIONS


Pre-specified feasibility criteria were not met, but deficits were remediable. Preliminary data support a definitive trial of MCC+ for migraine.
TRIAL REGISTRATION


This study is registered at Clinicaltrials.gov (NCT03177616).",2020,"MCC+ participants experienced greater reductions in migraine days (-2.9 days for MCC+ vs. -1.0 days for EUC, difference = -1.9; 95% confidence interval: -3.5, -0.4).
","['adult women with episodic migraine', 'Twenty-four of 29 MCC+ participants (83%) attended\u2009>\u200975% of the chiropractic sessions', 'migraine', '422 patients screened, 61 were randomized over 20 months']","['MCC', 'Multimodal chiropractic care', 'EUC', 'multimodal chiropractic care\u2009+\u2009enhanced usual care (MCC+) versus enhanced usual care alone (EUC']","['migraine days', 'feasibility of recruitment, retention, protocol adherence, and safety', 'daily migraine logs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0007129', 'cui_str': 'Merkel cell carcinoma'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",61.0,0.221263,"MCC+ participants experienced greater reductions in migraine days (-2.9 days for MCC+ vs. -1.0 days for EUC, difference = -1.9; 95% confidence interval: -3.5, -0.4).
","[{'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Rist', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Bernstein', 'Affiliation': ""John Graham Headache Center, Department of Neurology, Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Kowalski', 'Affiliation': ""Osher Clinical Center, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Kamila', 'Initials': 'K', 'LastName': 'Osypiuk', 'Affiliation': ""Osher Center for Integrative Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Julie P', 'Initials': 'JP', 'LastName': 'Connor', 'Affiliation': ""Osher Center for Integrative Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vining', 'Affiliation': 'Palmer College of Chiropractic, Davenport, IA, USA.'}, {'ForeName': 'Cynthia R', 'Initials': 'CR', 'LastName': 'Long', 'Affiliation': 'Palmer College of Chiropractic, Davenport, IA, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA.""}]",Cephalalgia : an international journal of headache,['10.1177/0333102420963844']
2624,33050728,Comparison between closed-loop insulin delivery system (the artificial pancreas) and sensor-augmented pump therapy: a randomised controlled crossover trial.,"OBJECTIVE


Several studies have shown that closed-loop automated insulin delivery (the artificial pancreas) improves glucose control compared to sensor-augmented pump therapy. We aimed to confirm these findings using our automated insulin delivery system based on the iPancreas platform.
RESEARCH DESIGN AND METHODS


We conducted a two-center randomised crossover trial comparing automated insulin delivery with sensor-augmented pump therapy in 36 adults with type 1 diabetes. Each intervention lasted 12 days in outpatient free-living conditions with no remote monitoring. The automated insulin delivery system used a model predictive control algorithm that was a less aggressive version of our earlier dosing algorithm to emphasize safety. The primary outcome was time in the range 3.9-10.0 mmol/L.
RESULTS


The automated insulin delivery system was operational 90.2% of the time. Compared to sensor-augmented pump therapy, automated insulin delivery increased time in range (3.9-10.0 mmol/L) from 61% (IQR 53 to 74) to 69% (60 to 73; p=0.006) and increased time in tight target range (3.9-7.8 mmol/L) from 37% (30 to 49) to 45% (35 to 51; p=0.011). Automated insulin delivery also reduced time spent below 3.9 mmol/ and 3.3 mmol/L from 3.5% (0.8 to 5.4) to 1.6% (1.1 to 2.7; p=0.0021) and from 0.9% (0.2 to 2.1) to 0.5% (0.2 to 1.1; p=0.0122), respectively. Time spent below 2.8 mmol/L was 0.2% (0.0 to 0.6) with sensor-augmented pump therapy and 0.1% (0.0 to 0.4; p=0.155) with automated insulin delivery.
CONCLUSIONS


Our study confirms findings that automated insulin delivery improves glucose control compared to sensor-augmented pump therapy (Funded by National Institute of Health; ClinicalTrials.gov number, NCT02846831).",2020,"Compared to sensor-augmented pump therapy, automated insulin delivery increased time in range (3.9-10.0 mmol/L) from 61% (IQR 53 to 74) to 69% (60 to 73; p=0.006) and increased time in tight target range (3.9-7.8 mmol/L) from 37% (30 to 49) to 45% (35 to 51; p=0.011).",['36 adults with type 1 diabetes'],"['automated insulin delivery with sensor-augmented pump therapy', 'closed-loop insulin delivery system (the artificial pancreas) and sensor-augmented pump therapy']","['automated insulin delivery system', 'time in tight target range', 'time spent', 'Time spent']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}]","[{'cui': 'C0336563', 'cui_str': 'Artificial pancreas'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",36.0,0.0682118,"Compared to sensor-augmented pump therapy, automated insulin delivery increased time in range (3.9-10.0 mmol/L) from 61% (IQR 53 to 74) to 69% (60 to 73; p=0.006) and increased time in tight target range (3.9-7.8 mmol/L) from 37% (30 to 49) to 45% (35 to 51; p=0.011).","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Haidar', 'Affiliation': 'McGill University, 5620, Biomedical Engineering, Montreal, Quebec, Canada; ahmad.haidar@mcgill.ca.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Legault', 'Affiliation': ""McGill University Health Centre, Montreal Children's Hospital, 2300 Tupper, Montreal, Quebec, Canada, H3H 1P3; laurent.legault@muhc.mcgill.ca.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Raffray', 'Affiliation': 'Institut de recherches cliniques de Montréal, 5598, Montreal, Quebec, Canada; marie.raffray@ircm.qc.ca.'}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Gouchie-Provencher', 'Affiliation': 'Research Institute of the McGill University Health Centre, 507266, Montreal, Quebec, Canada; nikita.gouchie-provencher@mcgill.ca.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Jacobs', 'Affiliation': 'Oregon Health & Science University, Department of Biomedical Engineering, 3303 SW Bond Ave, Portland, Oregon, United States, 97239; jacobsp@ohsu.edu.'}, {'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'El Fathi', 'Affiliation': 'McGill University, 5620, 3775 Rue University, Room 305, Montreal, Montreal, Quebec, Canada, H3A 2B4; anas.elfathi@mail.mcgill.ca.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Rutkowski', 'Affiliation': 'McGill University, 5620, Biomedical Engineering, Montreal, Quebec, Canada; joanna.rutkowski@mcgill.ca.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Messier', 'Affiliation': 'Institut de recherches cliniques de Montreal, Montreal, Quebec, Canada; virginie.messier@ircm.qc.ca.'}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Rabassa-Lhoret', 'Affiliation': 'Institut de Recherches Cliniques de Montreal, 110 Pine Ave W, Montreal, Quebec, Canada, H2W 1R7; Remi.Rabasa-Lhoret@ircm.qc.ca.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0365']
2625,33050732,Prospective study of association of characteristics of hotline psychological intervention in 778 high-risk callers with subsequent suicidal act.,"OBJECTIVES


This study aimed to assess the association of the quality scores of hotline psychological intervention and the reduction of subsequent suicidal acts among high suicidal risk callers.
METHODS


High-risk callers at a national crisis hotline service in China were recruited and prospectively followed for up to 3 months after receiving a hotline psychological intervention. The quality of the intervention was evaluated by supervisors who listened to the tape-recorded calls using the Counseling Skills Rating Scale for Psychological Support Hotlines, which assessed three counseling domains: process, attitude and communication skill. The primary outcome was the occurrence of suicidal acts during the follow-up period. Secondary outcomes were before versus after changes during the intake intervention call in hopefulness, psychological stress and suicide intention reported by the callers.
RESULTS


Over the 3-month follow-up, 45 of 778 high-risk callers reported 61 suicide attempts, and 3 other callers died by suicide. Subsequent suicidal act was significantly more common in callers classified as being at higher risk during the intake call. Higher scores on the quality of suicidality assessing of the Counseling Skills Rating Scale for Psychological Support Hotlines were associated with reduced risk of suicidal acts during follow-up (hazard ratio = 0.38, 95% confidence interval = [0.18, 0.85]). Higher scores on the communication skill domain were associated with increases in hopefulness (β = 0.09) after the intervention, and higher scores on the counseling process domain (β = -0.12) and higher suicidal risk scores (β = -0.12) were associated with decreased suicide intention after intervention.
CONCLUSION


Several characteristics of a hotline intervention for suicide prevention were associated with decreased risk of suicidal acts during follow-up. Intervention skill training for hotline operators should emphasize these specific counseling skills.",2020,"Higher scores on the communication skill domain were associated with increases in hopefulness (β = 0.09) after the intervention, and higher scores on the counseling process domain (β = -0.12) and higher suicidal risk scores (β = -0.12) were associated with decreased suicide intention after intervention.
","['778 high-risk callers with subsequent suicidal act', 'High-risk callers at a national crisis hotline service in China']","['Intervention skill training', 'hotline psychological intervention']","['intake intervention call in hopefulness, psychological stress and suicide intention reported by the callers', 'risk of suicidal acts', 'suicidal risk scores', 'quality of suicidality assessing of the Counseling Skills Rating Scale', 'communication skill domain', 'occurrence of suicidal acts', 'suicide intention']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0020042', 'cui_str': 'Telephone Hotlines'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0020042', 'cui_str': 'Telephone Hotlines'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",,0.0384338,"Higher scores on the communication skill domain were associated with increases in hopefulness (β = 0.09) after the intervention, and higher scores on the counseling process domain (β = -0.12) and higher suicidal risk scores (β = -0.12) were associated with decreased suicide intention after intervention.
","[{'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Tong', 'Affiliation': 'Beijing Suicide Research and Prevention Center, Beijing Hui Long Guan Hospital, Beijing, China.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Conner', 'Affiliation': 'Departments of Emergency Medicine and Psychiatry, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Cuiling', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Beijing Suicide Research and Prevention Center, Beijing Hui Long Guan Hospital, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Beijing Suicide Research and Prevention Center, Beijing Hui Long Guan Hospital, Beijing, China.'}, {'ForeName': 'Liting', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Beijing Suicide Research and Prevention Center, Beijing Hui Long Guan Hospital, Beijing, China.'}, {'ForeName': 'Yuehua', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Beijing Suicide Research and Prevention Center, Beijing Hui Long Guan Hospital, Beijing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Beijing Suicide Research and Prevention Center, Beijing Hui Long Guan Hospital, Beijing, China.'}]",The Australian and New Zealand journal of psychiatry,['10.1177/0004867420963739']
2626,31253454,Fostering Effective Asthma Self-Management Transfer in High-Risk Children: Gaps and Opportunities for Family Engagement.,"INTRODUCTION


The process of self-management knowledge, behavior, and skill development in children with asthma from families with low income is understudied.
METHOD


Fifteen mothers of children with uncontrolled asthma participated in semistructured interviews exploring the transfer of asthma self-management responsibilities from parent to child. Team members performed thematic analysis of written transcripts.
RESULTS


All participants were all the biological mothers and were impoverished, with most (73%) reporting an annual family income of less than $30,000. Their children ranged from 5 to 15 years old, were African American (100%), and had uncontrolled asthma based on national guidelines. Themes showed that child asthma self-management is difficult to achieve, that the transfer of asthma responsibility from mother to child is variable, and that mothers overestimate their child's developmental capacities for independent asthma self-management and have poor understanding of what well-controlled asthma means.
DISCUSSION


Ongoing assessment and tailored guidance from health care providers are critical to support the pivotal role of mothers in their child's self-management development process.",2019,"The process of self-management knowledge, behavior, and skill development in children with asthma from families with low income is understudied.
","['High-Risk Children', 'Fifteen mothers of children with uncontrolled asthma participated in semistructured interviews exploring the transfer of asthma self-management responsibilities from parent to child', 'All participants were all the biological mothers and were impoverished, with most (73%) reporting an annual family income of less than $30,000', 'Their children ranged from 5 to 15 years old, were African American (100%), and had uncontrolled asthma based on national guidelines', 'children with asthma from families with low income']",[],[],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C1319219', 'cui_str': 'Asthma self-management behavior'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0337486', 'cui_str': 'Natural mother'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",[],[],,0.0124432,"The process of self-management knowledge, behavior, and skill development in children with asthma from families with low income is understudied.
","[{'ForeName': 'Rachel H F', 'Initials': 'RHF', 'LastName': 'Margolis', 'Affiliation': ''}, {'ForeName': 'Melissa H', 'Initials': 'MH', 'LastName': 'Bellin', 'Affiliation': ''}, {'ForeName': 'Jaclyn R MacFarlane', 'Initials': 'JRM', 'LastName': 'Bookman', 'Affiliation': ''}, {'ForeName': 'Kathryn S', 'Initials': 'KS', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Mary Elizabeth', 'Initials': 'ME', 'LastName': 'Bollinger', 'Affiliation': ''}, {'ForeName': 'Cassia', 'Initials': 'C', 'LastName': 'Lewis-Land', 'Affiliation': ''}, {'ForeName': 'Arlene M', 'Initials': 'AM', 'LastName': 'Butz', 'Affiliation': ''}]",Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners,['10.1016/j.pedhc.2019.05.004']
2627,31379058,Predicting HBsAg clearance in genotype A chronic hepatitis B using HBsAg epitope profiling: A biomarker for functional cure.,"BACKGROUND AND AIM


Functional cure is the major goal of chronic hepatitis B (CHB) therapy though few biomarkers predict this outcome. HBsAg epitope occupancy can be influenced by therapeutic and immune pressure. The aim of this study was to map the HBsAg epitope profiles during long-term nucleos(t)ide analogue therapy in patients with genotype A CHB, in the context of HBsAg loss (SL)/seroconversion.
METHODS


We evaluated 25 genotype A CHB patients in the GS-US-174-0103 trial of HBeAg-positive CHB patients treated with tenofovir or adefovir for 4 years, 14 who achieved SL whilst 11 had no change. We epitope mapped the major domains of HBsAg to identify those patients with HBsAg clearance profile (CP) (loss of binding at both loops 1 and 2 epitopes of the 'a' determinant) vs non-clearance profile (no change in epitope recognition, or loss of epitope binding at one loop only), correlating this to on-treatment HBsAg responses. Complexed anti-HBs was also measured.
RESULTS


Analysis of the HBsAg epitope profiles of the 25 patients at baseline identified no predictive correlation with SL. In contrast, analysis at week 48 and end of study (week 192) or prior to SL identified significant predictive associations between development of HBsAg CPs and outcome of functional cure. The detection of a CP also correlated with the development of an alanine aminotransferase flare and detection of anti-HBs complexed with HBsAg.
CONCLUSION


The detection of HBsAg CPs by epitope mapping represents a novel viral biomarker, reflecting an emerging anti-HBs selection pressure prior to functional cure.",2019,"The detection of a CP also correlated with the development of an alanine aminotransferase flare and detection of anti-HBs complexed with HBsAg.
","['patients with genotype A CHB, in the context of HBsAg loss (SL)/seroconversion', '25 genotype A CHB patients in the GS-US-174-0103 trial of HBeAg-positive CHB patients treated with tenofovir or adefovir for 4\xa0years, 14 who achieved SL whilst 11 had no change']",['HBsAg epitope profiling'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0442739', 'cui_str': 'No status change'}]","[{'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0003316', 'cui_str': 'Epitope'}]",[],,0.0371727,"The detection of a CP also correlated with the development of an alanine aminotransferase flare and detection of anti-HBs complexed with HBsAg.
","[{'ForeName': 'Renae', 'Initials': 'R', 'LastName': 'Walsh', 'Affiliation': 'Division of Molecular Research and Development, Victorian Infectious Diseases Reference Laboratory, Doherty Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hammond', 'Affiliation': 'Division of Molecular Research and Development, Victorian Infectious Diseases Reference Laboratory, Doherty Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lilly', 'Initials': 'L', 'LastName': 'Yuen', 'Affiliation': 'Division of Molecular Research and Development, Victorian Infectious Diseases Reference Laboratory, Doherty Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Deerain', 'Affiliation': 'Division of Molecular Research and Development, Victorian Infectious Diseases Reference Laboratory, Doherty Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': ""O'Donnell"", 'Affiliation': 'Division of Molecular Research and Development, Victorian Infectious Diseases Reference Laboratory, Doherty Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Leary', 'Affiliation': 'Abbott Laboratories, Chicago, Illinois, USA.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Cloherty', 'Affiliation': 'Abbott Laboratories, Chicago, Illinois, USA.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Gaggar', 'Affiliation': 'Gilead Sciences, Foster City, California, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Kitrinos', 'Affiliation': 'Gilead Sciences, Foster City, California, USA.'}, {'ForeName': 'Mani', 'Initials': 'M', 'LastName': 'Subramanian', 'Affiliation': 'Gilead Sciences, Foster City, California, USA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Wong', 'Affiliation': ""Department of Gastroenterology, St Vincent's Hospital, Fitzroy, Victoria, Australia.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Locarnini', 'Affiliation': 'Division of Molecular Research and Development, Victorian Infectious Diseases Reference Laboratory, Doherty Institute, Melbourne, Victoria, Australia.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14207']
2628,31425366,Cow's Milk Allergic Infants on Elemental Formula Maintain Adequate Mineral Status Despite Using Acid-suppressive Drugs.,,2019,,"[""Cow's Milk Allergic Infants""]",[],[],"[{'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",[],[],,0.017234,,"[{'ForeName': 'Bryan M', 'Initials': 'BM', 'LastName': 'Harvey', 'Affiliation': ""Children's Investigational Research Program, LLC (ChiRP), Bentonville, AR, USA.""}, {'ForeName': 'Simone R B M', 'Initials': 'SRBM', 'LastName': 'Eussen', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht.'}, {'ForeName': 'Ardy', 'Initials': 'A', 'LastName': 'van Helvoort', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht.'}, {'ForeName': 'Lucien F', 'Initials': 'LF', 'LastName': 'Harthoorn', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002469']
2629,31487271,Linked dual-class HIV resistance mutations are associated with treatment failure.,"We hypothesized that HIV-1 with dual-class but not single-class drug resistance mutations linked on the same viral genome, present in the virus population before initiation of antiretroviral therapy (ART), would be associated with failure of ART to suppress viremia. To test this hypothesis, we utilized an ultrasensitive single-genome sequencing assay that detects rare HIV-1 variants with linked drug resistance mutations (DRMs). A case (ART failure) control (nonfailure) study was designed to assess whether linkage of DRMs in pre-ART plasma samples was associated with treatment outcome in the nevirapine/tenofovir/emtricitabine arm of the AIDS Clinical Trials Group A5208/Optimal Combined Therapy After Nevirapine Exposure (OCTANE) Trial 1 among women who had received prior single-dose nevirapine. Ultrasensitive single-genome sequencing revealed a significant association between pre-ART HIV variants with DRMs to 2 drug classes linked on the same genome (dual class) and failure of combination ART with 3 drugs to suppress viremia. In contrast, linked, single-class DRMs were not associated with ART failure. We conclude that linked dual-class DRMs present before the initiation of ART are associated with ART failure, whereas linked single-class DRMs are not.",2019,Ultrasensitive single-genome sequencing revealed a significant association between pre-ART HIV variants with DRMs to 2 drug classes linked on the same genome (dual class) and failure of combination ART with 3 drugs to suppress viremia.,['women who had received prior single-dose'],"['Combined Therapy', 'Nevirapine Exposure (OCTANE', 'nevirapine/tenofovir/emtricitabine', 'nevirapine']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0033972', 'cui_str': 'Combined therapy'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]",[],,0.0491262,Ultrasensitive single-genome sequencing revealed a significant association between pre-ART HIV variants with DRMs to 2 drug classes linked on the same genome (dual class) and failure of combination ART with 3 drugs to suppress viremia.,"[{'ForeName': 'Valerie F', 'Initials': 'VF', 'LastName': 'Boltz', 'Affiliation': 'HIV Dynamics and Replication Program, National Cancer Institute, Frederick, Maryland, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Shao', 'Affiliation': 'Leidos Biomedical Research, Inc., Frederick, Maryland, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Bale', 'Affiliation': 'HIV Dynamics and Replication Program, National Cancer Institute, Frederick, Maryland, USA.'}, {'ForeName': 'Elias K', 'Initials': 'EK', 'LastName': 'Halvas', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Luke', 'Affiliation': 'Leidos Biomedical Research, Inc., Frederick, Maryland, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'McIntyre', 'Affiliation': 'Anova Health Institute, Johannesburg, South Africa.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Schooley', 'Affiliation': 'UCSD, San Diego, California, USA.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Lockman', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Sawe', 'Affiliation': 'Kenya Medical Research Institute, Kericho, Kenya.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Hogg', 'Affiliation': 'Social & Scientific Systems, Silver Spring, Maryland, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hughes', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Kearney', 'Affiliation': 'HIV Dynamics and Replication Program, National Cancer Institute, Frederick, Maryland, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Coffin', 'Affiliation': 'Tufts University, Boston, Massachusetts, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Mellors', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}]",JCI insight,['10.1172/jci.insight.130118']
2630,31567658,Process Evaluation of the BearStand Behavioral Intervention: A Social Cognitive Theory-Based Approach to Reduce Occupational Sedentary Behavior.,"OBJECTIVE


Describe the process evaluation of the behavioral intervention group of a multicomponent workplace intervention, BearStand, to reduce employees' sitting time using sit-stand workstations and behavioral strategies.
METHODS


Process evaluation metrics: dose delivered, dose-received exposure, dose-received satisfaction, and context were collected using an online survey. Participants included employees of a US university.
RESULTS


Overall, 38 of 52 participants completed the process evaluation. The majority were satisfied (53%) with the intervention. Participants' interactions with intervention materials decreased over time (73.7%, week 1, to 52.6%, week 13), and 42% and 33% of participants used suggested videos and apps, respectively. Participants found goal setting and self-regulation strategies to be the most helpful and identified workplace-related contextual barriers that impacted intervention engagement.
CONCLUSIONS


Future interventions should incorporate more engaging materials for participants, reduce contextual barriers, and facilitate use of apps and videos.",2019,"Participants' interactions with intervention materials decreased over time (73.7%, week 1, to 52.6%, week 13), and 42% and 33% of participants used suggested videos and apps, respectively.",['Participants included employees of a US university'],['BearStand Behavioral Intervention'],[],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]",[],,0.0247273,"Participants' interactions with intervention materials decreased over time (73.7%, week 1, to 52.6%, week 13), and 42% and 33% of participants used suggested videos and apps, respectively.","[{'ForeName': 'Amanda H', 'Initials': 'AH', 'LastName': 'Wilkerson', 'Affiliation': 'Department of Health and Exercise Science, The University of Oklahoma, Norman, Oklahoma (Dr Wilkerson); Department of Health, Human Performance, & Recreation, Baylor University, Waco, TX (Ms Bridges, Dr McClendon, Dr Walsh); Department of Management, Hankamer School of Business, Baylor University, Waco, TX (Dr Wu); School of Education, Peru State College, Peru, Nebraska (Dr Walsh); Department of Health & Kinesiology, Texas A&M University, College Station (Dr Patterson); Department of Public Health (Dr Umstattd Meyer), Baylor University, Waco, Texas.'}, {'ForeName': 'Christina N', 'Initials': 'CN', 'LastName': 'Bridges', 'Affiliation': ''}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'McClendon', 'Affiliation': ''}, {'ForeName': 'Shana M', 'Initials': 'SM', 'LastName': 'Walsh', 'Affiliation': ''}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Patterson', 'Affiliation': ''}, {'ForeName': 'Renée M', 'Initials': 'RM', 'LastName': 'Umstattd Meyer', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001704']
2631,31707849,Predicting Benefit From Evolocumab Therapy in Patients With Atherosclerotic Disease Using a Genetic Risk Score: Results From the FOURIER Trial.,"BACKGROUND


The ability of a genetic risk score to predict risk in established cardiovascular disease and identify individuals who derive greater benefit from PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibition has not been established.
METHODS


We studied 14 298 patients with atherosclerotic cardiovascular disease from the FOURIER trial (Further Cardiovascular Outcomes Researh With PCSK9 Inhibition in Subjects With Elevated Risk). A 27-single-nucleotide polymorphism genetic risk score defined low (quintile 1), intermediate (quintiles 2-4), and high (quintile 5) genetic risk. Patients were also categorized by major atherosclerotic risk factors including diabetes mellitus, hypertension, low-density lipoprotein cholesterol ≥100 mg/dl, and smoking; multiple (≥2) risk factors was considered high clinical risk. Outcomes consisted of major coronary events (coronary heart death, myocardial infarction, or coronary revascularization) and major vascular events (major coronary events and ischemic stroke). Median follow-up was 2.3 years.
RESULTS


After we adjusted for clinical factors, the genetic risk score was associated with risk for both major vascular events ( P trend =0.005) and major coronary events ( P trend <0.0001). Individuals with intermediate and high genetic risk scores had 1.23- and 1.65-fold increased hazard for major coronary events, respectively. Elevated genetic risk was additive to major atherosclerotic risk factors and identified patients more likely to benefit from evolocumab. There was no benefit for major vascular events in patients without multiple clinical risk factors or high genetic risk (hazard ratio [HR], 1.02; absolute risk reduction [ARR], -0.2%,  P =0.86). In contrast, there was a 13% relative risk reduction (HR, 0.87 [0.75-0.998],  P =0.047) and a 1.4% ARR in patients with multiple clinical risk factors but without high genetic risk and a 31% relative risk reduction (HR, 0.69 [0.55-0.86],  P =0.0012), and 4.0% ARR in patients with high genetic risk, irrespective of clinical risk ( P trend  for HR=0.017, ARR  P trend =0.004). Patients with high genetic risk who received evolocumab had event rates similar to patients with a low burden of both genetic and clinical risk.
CONCLUSION


Patients without multiple clinical risk factors or high genetic risk had a low event rate and did not appear to derive benefit from evolocumab over 2.3 years. Conversely, patients with multiple clinical risk factors but without high genetic risk had intermediate risk and intermediate risk reduction. Patients with high genetic risk, regardless of clinical risk, had a high event rate and derived the greatest relative and absolute benefit from evolocumab, which mitigated this risk.",2020,"Outcomes consisted of major coronary events (coronary heart death, myocardial infarction, or coronary revascularization) and major vascular events (major coronary events and ischemic stroke).","['Patients With Atherosclerotic Disease Using a Genetic Risk Score', 'Patients were also categorized by major atherosclerotic risk factors including diabetes mellitus, hypertension, low-density lipoprotein cholesterol ≥100 mg/dl, and smoking; multiple (≥2) risk factors was considered high clinical risk', '14 298 patients with atherosclerotic cardiovascular disease from the FOURIER trial (Further Cardiovascular Outcomes Researh With PCSK9 Inhibition in Subjects With Elevated Risk', 'Patients with high genetic risk', 'Patients with high genetic risk who received']","['Evolocumab Therapy', 'evolocumab']","['major coronary events', 'major vascular events', 'genetic risk score', 'major coronary events (coronary heart death, myocardial infarction, or coronary revascularization) and major vascular events (major coronary events and ischemic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1426592', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 gene'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]",14298.0,0.0329015,"Outcomes consisted of major coronary events (coronary heart death, myocardial infarction, or coronary revascularization) and major vascular events (major coronary events and ischemic stroke).","[{'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Marston', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (N.A.M., F.K.K., F.N., Y.G., R.P.G., M.S.S., C.T.R.).""}, {'ForeName': 'Frederick K', 'Initials': 'FK', 'LastName': 'Kamanu', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (N.A.M., F.K.K., F.N., Y.G., R.P.G., M.S.S., C.T.R.).""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Nordio', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (N.A.M., F.K.K., F.N., Y.G., R.P.G., M.S.S., C.T.R.).""}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (N.A.M., F.K.K., F.N., Y.G., R.P.G., M.S.S., C.T.R.).""}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Roselli', 'Affiliation': 'Cardiovascular Disease Initiative, Broad Institute of MIT and Harvard Cambridge, MA (C.R., S.A.L., P.T.E.).'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Sever', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, United Kingdom (P.S.S.).'}, {'ForeName': 'Terje R', 'Initials': 'TR', 'LastName': 'Pedersen', 'Affiliation': 'Oslo University Hospital, Ulleval and Medical Faculty, University of Oslo, Norway (T.R.P.).'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Keech', 'Affiliation': 'Sydney Medical School, National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Australia (A.C.K.).'}, {'ForeName': 'Huei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Amgen, Thousand Oaks, CA (H.W., A.L.P.).'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Lira Pineda', 'Affiliation': 'Amgen, Thousand Oaks, CA (H.W., A.L.P.).'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (N.A.M., F.K.K., F.N., Y.G., R.P.G., M.S.S., C.T.R.).""}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Lubitz', 'Affiliation': 'Cardiovascular Disease Initiative, Broad Institute of MIT and Harvard Cambridge, MA (C.R., S.A.L., P.T.E.).'}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': 'Ellinor', 'Affiliation': 'Cardiovascular Disease Initiative, Broad Institute of MIT and Harvard Cambridge, MA (C.R., S.A.L., P.T.E.).'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (N.A.M., F.K.K., F.N., Y.G., R.P.G., M.S.S., C.T.R.).""}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (N.A.M., F.K.K., F.N., Y.G., R.P.G., M.S.S., C.T.R.).""}]",Circulation,['10.1161/CIRCULATIONAHA.119.043805']
2632,33053084,Immediate effects of semi-occluded vocal tract exercises in low and high voices: a self-perception study.,"PURPOSE


To investigate the self-perception by individuals on the immediate effects of three semi-occluded vocal tract exercises (SOVTE), that is, phonation into a latex tube, finger kazoo and phonation into a high-resistance straw, and to compare the self-perception results between the high and low voice groups.
METHOD


The study participants consisted of 26 choristers (seven sopranos, seven altos, six tenors, and six basses) subdivided into high and low voices with ages ranging from 18 to 58 years. Voice samples of each subject were recorded before and after performing the exercises randomly for three subsequent weeks. A self-assessment questionnaire was applied.
RESULTS


All exercises had a statistically significant improvement, according to the participants' self-perception. Latex tube phonation was the preferred technique for 11 (84.62%) participants in the low voice group; while the high-resistance straw was reported as the less beneficial exercise by 10 (79.92%) participants in the same group. On the other hand, the high-resistance straw (9; 69.2%) was the preferred exercise for the high voice group; while finger kazoo (6; 46.15%) and latex tube (5; 38.4%) were the least beneficial exercises.
CONCLUSION


The study showed that the effects of these exercises are different and should be suited for each type of voice, such as the latex tube, which was the most preferred by low voice participants and also rated as less beneficial by high voice participants, and the high-resistance straw, which was the most preferred by the high voice participants and also rated as less beneficial by low voice participants.",2020,Latex tube phonation was the preferred technique for 11 (84.62%) participants in the low voice group; while the high-resistance straw was reported as the less beneficial exercise by 10 (79.92%) participants in the same group.,"['low and high voices', 'participants consisted of 26 choristers (seven sopranos, seven altos, six tenors, and six basses) subdivided into high and low voices with ages ranging from 18 to 58 years']","['three semi-occluded vocal tract exercises (SOVTE', 'semi-occluded vocal tract exercises']","['beneficial exercise', 'Latex tube phonation']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0004830', 'cui_str': 'Bass'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023115', 'cui_str': 'Latex'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0031577', 'cui_str': 'Laryngeal voice function'}]",,0.0123555,Latex tube phonation was the preferred technique for 11 (84.62%) participants in the low voice group; while the high-resistance straw was reported as the less beneficial exercise by 10 (79.92%) participants in the same group.,"[{'ForeName': 'Diego Henrique da Cruz', 'Initials': 'DHDC', 'LastName': 'Martinho', 'Affiliation': 'Departamento de Desenvolvimento Humano e Reabilitação da Faculdade de Ciências Médicas da Universidade Estadual de Campinas - UNICAMP - Campinas (SP), Brasil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Constantini', 'Affiliation': 'Departamento de Desenvolvimento Humano e Reabilitação da Faculdade de Ciências Médicas da Universidade Estadual de Campinas - UNICAMP - Campinas (SP), Brasil.'}]",CoDAS,['10.1590/2317-1782/20202019079']
2633,33053090,Diagnostic precision for bronchopulmonary aspiration in a heterogeneous population.,"PURPOSE


The purpose of the present study was to assess the validity of a simple instrument for screening dysphagia used in a large public hospital in Brazil with heterogeneous adult population.
METHOD


The Dysphagia Risk Evaluation Protocol (DREP) - screening version contains four items (altered cervical auscultation, altered vocal quality, coughing and choking before / during / after swallowing) that were previously indicated as independent risk factors associated to the presence of dysphagia in the swallowing test with water. Trained speech therapists administered and scored DREP - screening version to consecutive patients referred by hospital's medical team to perform Video Fluoroscopic for Swallowing Study (VFSS).
RESULTS


211 patients received the swallowing screen (DREP): 99 failed and 112 passed. One in every five patients was randomized to receive a VFSS. The DREP screening version demonstrated excellent validity with sensitivity at 92.9%, specificity at 75.0%, negative predictive values at 95.5% and an accuracy of 80.9%.
CONCLUSION


The DREP - screening version is a simple and accurate tool to identify the risk for penetration and / or aspiration in patients who are not tube-fed, who have a good level of alertness, have no history of recurrent pneumonia, are not on pneumonia, and that do not use a tracheostomy cannula.",2020,"The DREP screening version demonstrated excellent validity with sensitivity at 92.9%, specificity at 75.0%, negative predictive values at 95.5% and an accuracy of 80.9%.
","[""consecutive patients referred by hospital's medical team to perform Video Fluoroscopic for Swallowing Study (VFSS"", 'screening dysphagia used in a large public hospital in Brazil with heterogeneous adult population', '211 patients received the swallowing screen (DREP): 99 failed and 112 passed']","['Trained speech therapists administered and scored DREP - screening version', 'VFSS']","['negative predictive values', 'Dysphagia Risk Evaluation Protocol (DREP) - screening version contains four items (altered cervical auscultation, altered vocal quality, coughing and choking']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0553514', 'cui_str': 'Referral source'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3888792', 'cui_str': 'Swallow study'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0242960', 'cui_str': 'Heterogeneity, Genetic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0402015', 'cui_str': 'Speech and language therapist'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0008301', 'cui_str': 'Choking'}]",211.0,0.0328642,"The DREP screening version demonstrated excellent validity with sensitivity at 92.9%, specificity at 75.0%, negative predictive values at 95.5% and an accuracy of 80.9%.
","[{'ForeName': 'Maíra Santilli de', 'Initials': 'MS', 'LastName': 'Lima', 'Affiliation': 'Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo - USP - São Paulo (SP), Brasil.'}, {'ForeName': 'Fernanda Chiarion', 'Initials': 'FC', 'LastName': 'Sassi', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional, Faculdade de Medicina da Universidade de São Paulo - USP - São Paulo (SP), Brasil.'}, {'ForeName': 'Gisele Chagas de', 'Initials': 'GC', 'LastName': 'Medeiros', 'Affiliation': 'Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo - USP - São Paulo (SP), Brasil.'}, {'ForeName': 'Shri Krishna', 'Initials': 'SK', 'LastName': 'Jayanthi', 'Affiliation': 'Instituto de Radiologia, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo - USP - São Paulo (SP), Brasil.'}, {'ForeName': 'Claudia Regina Furquim de', 'Initials': 'CRF', 'LastName': 'Andrade', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional, Faculdade de Medicina da Universidade de São Paulo - USP - São Paulo (SP), Brasil.'}]",CoDAS,['10.1590/2317-1782/20202019166']
2634,33053113,Effects of the prophylactic use of escitalopram on the prognosis and the plasma copeptin level in patients with acute cerebral infarction.,"This study aimed to investigate whether the routine administration of escitalopram for three months would improve the prognosis of patients with ischemic stroke and decrease the plasma copeptin level. A total of 97 patients with acute cerebral infarction were randomly allocated to receive escitalopram (5-10 mg once per day, orally; n=49) or not to receive escitalopram (control group; n=48) for 12 weeks starting at 2-7 days after the onset of stroke. Both groups received conventional treatments, including physiotherapy and secondary prevention of stroke. The National Institutes of Health Stroke Scale (NIHSS) score was used to evaluate the disability of patients at the initial evaluation and at the monthly follow-up visits for three months. Impairment in the daily activities was assessed using the Barthel Index (BI), while cognitive impairment was assessed using Mini-Mental State Examination (MMSE) score. The psychiatric assessment included the administration of the Present State Examination modified to identify Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) symptoms of depression. The severity of depression was measured using the 17-item Hamilton Rating Scale for Depression (HAMD). During the 3-month follow-up period, 95 patients were included in the analysis (two patients withdrew from the escitalopram group). NIHSS and BI improvement at the 90th day were significantly greater in the escitalopram group (P<0.05), while HAMD and plasma copeptin levels significantly decreased, compared to the control group (P<0.01). In patients with acute ischemic stroke, the earlier administration of escitalopram for three months may improve neurological functional prognosis and decrease copeptin level.",2020,"NIHSS and BI improvement at the 90th day were significantly greater in the escitalopram group (P<0.05), while HAMD and plasma copeptin levels significantly decreased, compared to the control group (P<0.01).","['97 patients with acute cerebral infarction', 'patients with ischemic stroke', 'patients with acute cerebral infarction', 'patients with acute ischemic stroke']","['escitalopram (5-10 mg once per day, orally; n=49) or not to receive escitalopram', 'escitalopram']","['Barthel Index (BI), while cognitive impairment was assessed using Mini-Mental State Examination (MMSE) score', 'Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) symptoms of depression', 'severity of depression', 'neurological functional prognosis and decrease copeptin level', 'Health Stroke Scale (NIHSS) score', 'NIHSS and BI improvement', '17-item Hamilton Rating Scale for Depression (HAMD', 'plasma copeptin level', 'HAMD and plasma copeptin levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0056279', 'cui_str': 'copeptins'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",97.0,0.0563996,"NIHSS and BI improvement at the 90th day were significantly greater in the escitalopram group (P<0.05), while HAMD and plasma copeptin levels significantly decreased, compared to the control group (P<0.01).","[{'ForeName': 'Jin-Xia', 'Initials': 'JX', 'LastName': 'Cao', 'Affiliation': ""Department of Neuropsychiatry, The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Neuropsychiatry, The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China.""}, {'ForeName': 'Yun-Tao', 'Initials': 'YT', 'LastName': 'Sun', 'Affiliation': ""Department of Neuropsychiatry, The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China.""}, {'ForeName': 'Qing-Hong', 'Initials': 'QH', 'LastName': 'Zeng', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Laboratory, The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China.""}, {'ForeName': 'Jie-Chun', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China.""}]",Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas,['10.1590/1414-431X20208930']
2635,33053116,A novel stem cell therapy for hepatitis B virus-related acute-on-chronic liver failure.,"The aim of this study was to propose a stem cell therapy for hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) based on plasma exchange (PE) for peripheral blood stem cell (PBSC) collection and examine its safety and efficacy. Sixty patients (n=20 in each group) were randomized to PE (PE alone), granulocyte colony-stimulating factor (G-CSF) (PE after G-CSF treatment), and PBSC transplantation (PBSCT) (G-CSF, PE, PBSC collection and hepatic artery injection) groups. Patients were followed-up for 24 weeks. Liver function and adverse events were recorded. Survival analysis was performed. PBSCT improved blood ammonia levels at 1 week (P<0.05). The level of total bilirubin, international normalized ratio, and creatinine showed significant differences in the 4th week of treatment (P<0.05). The survival rates of the PE, G-CSF, and PBSCT groups were 50, 65, and 85% at 90 days (P=0.034). There was a significant difference in 90-day survival between the PE and PBSCT groups (P=0.021). The preliminary results suggested that PBSCT was safe, with a possibility of improved 90-day survival in patients with HBV-ACLF.",2020,There was a significant difference in 90-day survival between the PE and PBSCT groups (P=0.021).,"['patients with HBV-ACLF', 'Sixty patients (n=20 in each group', 'hepatitis B virus-related acute-on-chronic liver failure', 'hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF']","['PE (PE alone), granulocyte colony-stimulating factor (G-CSF) (PE after G-CSF treatment), and PBSC transplantation (PBSCT', 'PBSCT']","['survival rates', 'blood ammonia levels', 'Liver function and adverse events', '90-day survival', 'level of total bilirubin, international normalized ratio, and creatinine']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C3850141', 'cui_str': 'Acute on chronic liver failure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242602', 'cui_str': 'Peripheral blood stem cell graft'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0428437', 'cui_str': 'Blood ammonia measurement'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",,0.070712,There was a significant difference in 90-day survival between the PE and PBSCT groups (P=0.021).,"[{'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Medical School of Chinese PLA, Beijing, China.'}, {'ForeName': 'Shaoli', 'Initials': 'S', 'LastName': 'You', 'Affiliation': 'Liver Failure Treatment and Research Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yihui', 'Initials': 'Y', 'LastName': 'Rong', 'Affiliation': 'Department of Infection and Liver Diseases, Peking University International Hospital, Beijing, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Interventional Therapy, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Sa', 'Initials': 'S', 'LastName': 'Lv', 'Affiliation': 'Liver Failure Treatment and Research Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Fangjiao', 'Initials': 'F', 'LastName': 'Song', 'Affiliation': 'Liver Failure Treatment and Research Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Hongling', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Liver Transplantation Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Huaming', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Interventional Therapy, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Liver Failure Treatment and Research Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Dongze', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Liver Failure Treatment and Research Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Wanshu', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Liver Failure Treatment and Research Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Shaojie', 'Initials': 'S', 'LastName': 'Xin', 'Affiliation': 'Medical School of Chinese PLA, Beijing, China.'}]",Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas,['10.1590/1414-431X20209728']
2636,33053245,Effect of shock wave therapy associated with aerobic exercise on cellulite: a randomized controlled trial.,"INTRODUCTION


Cellulite is a multifactor and controversial condition. Several methods have been explored to reduce it, not always with favorable results. Shock Wave Therapy has been shown to be effective, but the results of its association with an Aerobic Exercise Program are unknown.
PURPOSE


To verify whether Shock Wave Therapy in association with an Aerobic Exercise Program reduces the degree of severity of Cellulite in the gluteal region and in the ⅓ of the proximal posterior of the thigh.
METHODOLOGY


45 healthy women, aged from 18 to 32, randomly assigned, considering the severity degree in the Cellulite Severity Scale and the level of physical activity, in 3 groups: two experimental and one control group. The control group performed the evaluations. The experimental group 1 performed an Aerobic Exercise Program, and the experimental group 2 associated this program with a Radial Shock Wave Therapy protocol. The experimental groups completed 6 interventions within 3 weeks. In addition, the degree of severity in the Cellulite Severity Scale, height, body composition, skin temperature, and subcutaneous adipose tissue thickness were assessed. One-way ANOVA test and Kruskal Wallis were used to obtain the results, with level of significance of 0.05.
RESULTS


42 women completed the study. There was a significant reduction in the severity of Cellulite between experimental group 2 and group 1 (p=0.032), and from group 2 to the control group (p=0.042).
CONCLUSION


The association of Shock Wave Therapy and Aerobic Exercise was shown to be effective in reducing the severity of cellulite. Clinical trials: NCT03986983.",2020,"There was a significant reduction in the severity of Cellulite between experimental group 2 and group 1 (p=0.032), and from group 2 to the control group (p=0.042).
","['45 healthy women, aged from 18 to 32', 'cellulite', '42 women completed the study']","['Aerobic Exercise Program', 'aerobic exercise', 'shock wave therapy', 'Aerobic Exercise Program, and the experimental group 2 associated this program with a Radial Shock Wave Therapy protocol']","['severity of Cellulite', 'degree of severity in the Cellulite Severity Scale, height, body composition, skin temperature, and subcutaneous adipose tissue thickness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0424624', 'cui_str': 'Fatty dimpling of skin'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0424624', 'cui_str': 'Fatty dimpling of skin'}, {'cui': 'C0441982', 'cui_str': 'Degrees of severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",45.0,0.0272538,"There was a significant reduction in the severity of Cellulite between experimental group 2 and group 1 (p=0.032), and from group 2 to the control group (p=0.042).
","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Troia', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Porto, Portugal.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Moreira', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Porto, Portugal.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pisco', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Porto, Portugal.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Noites', 'Affiliation': 'Center for Rehabilitation Research (CIR)- Human Movement System (Re) habilitation, Polytechnic Institute of Porto, Porto, Portugal.'}, {'ForeName': 'Ana Luisa', 'Initials': 'AL', 'LastName': 'Vale', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Porto, Portugal.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Carvalho', 'Affiliation': 'Center for Rehabilitation Research (CIR)- Human Movement System (Re) habilitation, Polytechnic Institute of Porto, Porto, Portugal.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Vilarinho', 'Affiliation': 'Center for Rehabilitation Research (CIR)- Human Movement System (Re) habilitation, Polytechnic Institute of Porto, Porto, Portugal.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13791']
2637,33053252,"Impact of the DC/TMD instructional video on the practical skills of undergraduate students - a single-blinded, randomized controlled trial.","INTRODUCTION


Competencies in the clinical examination of patients with temporomandibular disorders (TMD) can be achieved by self-instruction. This study aimed to identify the impact of the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) instructional video on the practical examination skills of undergraduate students.
MATERIALS AND METHODS


One week prior to completing an objective structured clinical examination (OSCE) addressing the examination of patients with TMD, undergraduate students in their third year received either the DC/TMD manual (control group) or additionally watched the instructional video once (intervention group). After passing the OSCE, a feedback questionnaire was completed by the students.
RESULTS


50 undergraduates were recruited to take part in the OSCE prior to their first clinical course. The sum scores achieved in the stations were higher in the intervention group, but missed significance. Participants of the intervention group more often agreed that completing the OSCE stations was easy, which was significant for one station (p = 0.023). 95.8 % of the participating students supported the implementation of the video in dental education.
DISCUSSION


Due to the conception of the study, the video was only presented once to ensure that the control group had no access to the medium at all. However, it might be interesting to investigate whether repeated watching of the video enhances its effect.
CONCLUSIONS


Clinical competencies in the examination of TMD patients can be achieved by self-instruction with the DC/TMD manual and instructional video. Watching the video for educational purposes was highly recommended by undergraduate students.",2020,"Participants of the intervention group more often agreed that completing the OSCE stations was easy, which was significant for one station (p = 0.023).","['patients with temporomandibular disorders (TMD', 'undergraduate students', '50 undergraduates were recruited to take part in the OSCE prior to their first clinical course', 'patients with TMD, undergraduate students in their third year received either the']","['DC/TMD instructional video', 'DC/TMD manual (control group) or additionally watched the instructional video once (intervention group']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0449259', 'cui_str': 'Clinical course'}]","[{'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],50.0,0.0346906,"Participants of the intervention group more often agreed that completing the OSCE stations was easy, which was significant for one station (p = 0.023).","[{'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Rauch', 'Affiliation': 'Department of Prosthodontics and Materials Science, University of Leipzig, Liebigstr. 10, Haus 1, 04103, Leipzig, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Jahn', 'Affiliation': 'Department of Prosthodontics and Materials Science, University of Leipzig, Liebigstr. 10, Haus 1, 04103, Leipzig, Germany.'}, {'ForeName': 'Anuschka', 'Initials': 'A', 'LastName': 'Roesner', 'Affiliation': 'Department of Prosthodontics and Materials Science, University of Leipzig, Liebigstr. 10, Haus 1, 04103, Leipzig, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Hahnel', 'Affiliation': 'Department of Prosthodontics and Materials Science, University of Leipzig, Liebigstr. 10, Haus 1, 04103, Leipzig, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Schierz', 'Affiliation': 'Department of Prosthodontics and Materials Science, University of Leipzig, Liebigstr. 10, Haus 1, 04103, Leipzig, Germany.'}]",European journal of dental education : official journal of the Association for Dental Education in Europe,['10.1111/eje.12618']
2638,33053258,Effect of Action-Based Cognitive Remediation on cognitive impairment in patients with remitted bipolar disorder: a randomised controlled trial.,"OBJECTIVES


Cognitive impairment affects many patients with bipolar disorder (BD), and treatments with replicated pro-cognitive effects are lacking. This study aimed to assess the effect of Action-Based Cognitive Remediation (ABCR) vs. control treatment on cognitive impairment in patients with BD.
METHODS


Patients with remitted BD with objective cognitive impairment were randomised to 10 weeks of ABCR vs. control treatment, and assessed at baseline, after three weeks of treatment, at treatment completion and at 6 months follow-up. The primary outcome was a cognitive composite score. Secondary outcomes were executive function and observer-rated functional capacity. Tertiary measures included additional neuropsychological tests, performance-based functional capacity and quality of life. Data were analysed with linear mixed effects models.
RESULTS


In total, 64 participants were randomised; given three dropouts before the baseline assessments, data were analysed for 61 participants (ABCR: n=32, control: n=29). There was no effect on ABCR vs. control on the primary cognitive composite score (p-values ≥0.60). At treatment completion, there was a large effect of ABCR vs. control on the secondary executive function measure (treatment effect= -0.16, 95% CI [-0.27, -0.05], p≤0.01, d=0.65), and on subjective cognitive functioning (treatment effect= -5.38, 95% CI [-8.13, -2.67, p≤0.001, d=0.80), which disappeared at follow-up. There was no treatment-effect on functioning, and no association between cognitive and functional change.
CONCLUSIONS


There was no effect of ABCR on the cognitive composite score. However, there was an effect on executive function and subjective cognitive functioning suggesting that ABCR may be relevant for patients with executive dysfunction.",2020,"At treatment completion, there was a large effect of ABCR vs. control on the secondary executive function measure (treatment effect= -0.16, 95% CI [-0.27, -0.05], p≤0.01, d=0.65), and on subjective cognitive functioning (treatment effect=","['patients with BD', 'patients with executive dysfunction', '64 participants were randomised; given three dropouts before the baseline assessments, data were analysed for 61 participants (ABCR: n=32, control: n=29', 'Patients with remitted BD with objective cognitive impairment', 'patients with bipolar disorder (BD', 'patients with remitted bipolar disorder']","['Action-Based Cognitive Remediation (ABCR) vs. control treatment', 'ABCR', 'Action-Based Cognitive Remediation', 'ABCR vs. control treatment']","['primary cognitive composite score', 'additional neuropsychological tests, performance-based functional capacity and quality of life', 'cognitive impairment', 'executive function and observer-rated functional capacity', 'cognitive composite score', 'secondary executive function measure', 'executive function and subjective cognitive functioning', 'cognitive and functional change', 'subjective cognitive functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C2748208', 'cui_str': 'Executive dysfunction'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",64.0,0.244971,"At treatment completion, there was a large effect of ABCR vs. control on the secondary executive function measure (treatment effect= -0.16, 95% CI [-0.27, -0.05], p≤0.01, d=0.65), and on subjective cognitive functioning (treatment effect=","[{'ForeName': 'Caroline V', 'Initials': 'CV', 'LastName': 'Ott', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Maj', 'Initials': 'M', 'LastName': 'Vinberg', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lars V', 'Initials': 'LV', 'LastName': 'Kessing', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bowie', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Forman', 'Affiliation': 'Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kamilla W', 'Initials': 'KW', 'LastName': 'Miskowiak', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]",Bipolar disorders,['10.1111/bdi.13021']
2639,33053279,Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates.,"BACKGROUND


Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and the resulting disease, coronavirus disease 2019 (Covid-19), have spread to millions of persons worldwide. Multiple vaccine candidates are under development, but no vaccine is currently available. Interim safety and immunogenicity data about the vaccine candidate BNT162b1 in younger adults have been reported previously from trials in Germany and the United States.
METHODS


In an ongoing, placebo-controlled, observer-blinded, dose-escalation, phase 1 trial conducted in the United States, we randomly assigned healthy adults 18 to 55 years of age and those 65 to 85 years of age to receive either placebo or one of two lipid nanoparticle-formulated, nucleoside-modified RNA vaccine candidates: BNT162b1, which encodes a secreted trimerized SARS-CoV-2 receptor-binding domain; or BNT162b2, which encodes a membrane-anchored SARS-CoV-2 full-length spike, stabilized in the prefusion conformation. The primary outcome was safety (e.g., local and systemic reactions and adverse events); immunogenicity was a secondary outcome. Trial groups were defined according to vaccine candidate, age of the participants, and vaccine dose level (10 μg, 20 μg, 30 μg, and 100 μg). In all groups but one, participants received two doses, with a 21-day interval between doses; in one group (100 μg of BNT162b1), participants received one dose.
RESULTS


A total of 195 participants underwent randomization. In each of 13 groups of 15 participants, 12 participants received vaccine and 3 received placebo. BNT162b2 was associated with a lower incidence and severity of systemic reactions than BNT162b1, particularly in older adults. In both younger and older adults, the two vaccine candidates elicited similar dose-dependent SARS-CoV-2-neutralizing geometric mean titers, which were similar to or higher than the geometric mean titer of a panel of SARS-CoV-2 convalescent serum samples.
CONCLUSIONS


The safety and immunogenicity data from this U.S. phase 1 trial of two vaccine candidates in younger and older adults, added to earlier interim safety and immunogenicity data regarding BNT162b1 in younger adults from trials in Germany and the United States, support the selection of BNT162b2 for advancement to a pivotal phase 2-3 safety and efficacy evaluation. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.).",2020,"BNT162b2 was associated with a lower incidence and severity of systemic reactions than BNT162b1, particularly in older adults.","['younger adults', '195 participants underwent randomization', 'Trial groups were defined according to vaccine candidate, age of the participants, and vaccine dose level (10 μg, 20 μg, 30 μg, and 100 μg', 'younger adults from trials in Germany and the United States', '13 groups of 15 participants, 12 participants received', 'healthy adults 18 to 55 years of age and those 65 to 85 years of age to receive either', 'younger and older adults']","['placebo or one of two lipid nanoparticle-formulated, nucleoside-modified RNA vaccine candidates: BNT162b1', 'placebo', 'vaccine', 'Two RNA-Based Covid-19 Vaccine Candidates']","['Safety and Immunogenicity', 'safety (e.g., local and systemic reactions and adverse events); immunogenicity']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",195.0,0.498477,"BNT162b2 was associated with a lower incidence and severity of systemic reactions than BNT162b1, particularly in older adults.","[{'ForeName': 'Edward E', 'Initials': 'EE', 'LastName': 'Walsh', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Frenck', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Ann R', 'Initials': 'AR', 'LastName': 'Falsey', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Kitchin', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Absalon', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Gurtman', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lockhart', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Neuzil', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Mulligan', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Bailey', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Kena A', 'Initials': 'KA', 'LastName': 'Swanson', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Koury', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Kalina', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cooper', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Fontes-Garfias', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Pei-Yong', 'Initials': 'PY', 'LastName': 'Shi', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Türeci', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Tompkins', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Lyke', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Raabe', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Dormitzer', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Uğur', 'Initials': 'U', 'LastName': 'Şahin', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}]",The New England journal of medicine,['10.1056/NEJMoa2027906']
2640,33053283,Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis.,"BACKGROUND


Upadacitinib is an oral selective Janus kinase inhibitor to treat rheumatoid arthritis. The efficacy and safety of upadacitinib as compared with abatacept, a T-cell costimulation modulator, in patients with rheumatoid arthritis refractory to biologic disease-modifying antirheumatic drugs (DMARDs) are unclear.
METHODS


In this 24-week, phase 3, double-blind, controlled trial, we randomly assigned patients in a 1:1 ratio to receive oral upadacitinib (15 mg once daily) or intravenous abatacept, each in combination with stable synthetic DMARDs. The primary end point was the change from baseline in the composite Disease Activity Score for 28 joints based on the C-reactive protein level (DAS28-CRP; range, 0 to 9.4, with higher scores indicating more disease activity) at week 12, assessed for noninferiority. Key secondary end points at week 12 were the superiority of upadacitinib over abatacept in the change from baseline in the DAS28-CRP and the percentage of patients having clinical remission according to a DAS28-CRP of less than 2.6.
RESULTS


A total of 303 patients received upadacitinib, and 309 patients received abatacept. From baseline DAS28-CRP values of 5.70 in the upadacitinib group and 5.88 in the abatacept group, the mean change at week 12 was -2.52 and -2.00, respectively (difference, -0.52 points; 95% confidence interval [CI], -0.69 to -0.35; P<0.001 for noninferiority; P<0.001 for superiority). The percentage of patients having remission was 30.0% with upadacitinib and 13.3% with abatacept (difference, 16.8 percentage points; 95% CI, 10.4 to 23.2; P<0.001 for superiority). During the treatment period, one death, one nonfatal stroke, and two venous thromboembolic events occurred in the upadacitinib group, and more patients in the upadacitinib group than in the abatacept group had elevated hepatic aminotransferase levels.
CONCLUSIONS


In patients with rheumatoid arthritis refractory to biologic DMARDs, upadacitinib was superior to abatacept in the change from baseline in the DAS28-CRP and the achievement of remission at week 12 but was associated with more serious adverse events. Longer and larger trials are required in order to determine the effect and safety of upadacitinib in patients with rheumatoid arthritis. (Funded by AbbVie; SELECT-CHOICE Clinicaltrials.gov number, NCT03086343.).",2020,"The percentage of patients having remission was 30.0% with upadacitinib and 13.3% with abatacept (difference, 16.8 percentage points; 95% CI, 10.4 to 23.2; P<0.001 for superiority).","['303 patients received upadacitinib, and 309 patients received', 'Rheumatoid Arthritis', 'patients with rheumatoid arthritis', 'patients with rheumatoid arthritis refractory to biologic disease-modifying antirheumatic drugs (DMARDs']","['abatacept', 'oral upadacitinib (15 mg once daily) or intravenous abatacept, each in combination with stable synthetic DMARDs', 'Upadacitinib or Abatacept']","['disease activity', 'superiority of upadacitinib over abatacept', 'death, one nonfatal stroke, and two venous thromboembolic events', 'elevated hepatic aminotransferase levels', 'percentage of patients having remission', 'composite Disease Activity Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C1619966', 'cui_str': 'abatacept'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C1619966', 'cui_str': 'abatacept'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}]",303.0,0.246607,"The percentage of patients having remission was 30.0% with upadacitinib and 13.3% with abatacept (difference, 16.8 percentage points; 95% CI, 10.4 to 23.2; P<0.001 for superiority).","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rubbert-Roth', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Enejosa', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Aileen L', 'Initials': 'AL', 'LastName': 'Pangan', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Boulos', 'Initials': 'B', 'LastName': 'Haraoui', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Rischmueller', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Khan', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Ricardo M', 'Initials': 'RM', 'LastName': 'Xavier', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}]",The New England journal of medicine,['10.1056/NEJMoa2008250']
2641,33053561,Subthreshold Pan-retinal Photocoagulation Using Endpoint Management Algorithm for Severe Non-proliferative Diabetic Retinopathy: A Paired Controlled Pilot Prospective Study.,"PURPOSE


To report the efficacy and safety profile of subthreshold pan-retinal photocoagulation (PRP) using endpoint management (EPM) algorithm compared with conventional threshold PASCAL PRP for the treatment of severe non-proliferative diabetic retinopathy (NPDR).
METHODS


This was a prospective, single center, paired randomized controlled trial of fifty-six eyes of twenty-eight participants with bilateral symmetric severe NPDR. One eye of the participant was randomly assigned to receive the subthreshold EPM PRP, while the other eye of the same participant received the threshold PASCAL PRP. The primary outcome measures included the difference in the one-year risk of progression to PDR between two groups, and mean changes of the logarithm of the minimal angle of resolution (logMAR) visual acuity (VA). The second outcome measures included central foveal thickness (CFT), one-year risk of progression to PDR, and visual field (VF) parameters.
RESULTS


The subthreshold EPM PRP group and the threshold PASCAL PRP group had similar one-year risk of progression to PDR during the 12-month follow-up visits (17.86% vs 14.29%, P>0.05). Slightly decreased VA was found in both groups (0.08 vs 0.09 logMAR VA), however, no statistical difference was found for neither group (P>0.05). Similar results were found for thickened CFT for both groups (23.59μm vs 28.34μm, P>0.05). Specifically, although substantial loss of VF was found in the threshold PASCAL PRP group (P<0.05), no obvious damage to VF was seen in the subthreshold EPM PRP group (P>0.05).
CONCLUSION


The subthreshold EPM PRP is non-inferior to the conventional threshold PASCAL PRP in the treatment of severe NPDR during 12-month follow-up and could be an alternative treatment option for patients with severe NPDR.",2020,"Specifically, although substantial loss of VF was found in the threshold PASCAL PRP group (P<0.05), no obvious damage to VF was seen in the subthreshold EPM PRP group (P>0.05).
","['patients with severe NPDR', 'severe non-proliferative diabetic retinopathy (NPDR', 'Severe Non-proliferative Diabetic Retinopathy', 'fifty-six eyes of twenty-eight participants with bilateral symmetric severe NPDR']","['subthreshold pan-retinal photocoagulation (PRP) using endpoint management (EPM) algorithm', 'Subthreshold Pan-retinal Photocoagulation Using Endpoint Management Algorithm', 'subthreshold EPM PRP', 'threshold PASCAL PRP', 'conventional threshold PASCAL PRP']","['one-year risk of progression to PDR', 'substantial loss of VF', 'mean changes of the logarithm of the minimal angle of resolution (logMAR) visual acuity (VA', 'central foveal thickness (CFT), one-year risk of progression to PDR, and visual field (VF) parameters', 'VA', 'thickened CFT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004606', 'cui_str': 'Nonproliferative diabetic retinopathy'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}]","[{'cui': 'C0030266', 'cui_str': 'Panama'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0439473', 'cui_str': 'Pa'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1845050', 'cui_str': 'Pigmentary Disorder, Reticulate, with Systemic Manifestations'}, {'cui': 'C3887875', 'cui_str': 'Visual field defect'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}]",56.0,0.0346083,"Specifically, although substantial loss of VF was found in the threshold PASCAL PRP group (P<0.05), no obvious damage to VF was seen in the subthreshold EPM PRP group (P>0.05).
","[{'ForeName': 'Kunbei', 'Initials': 'K', 'LastName': 'Lai', 'Affiliation': ''}, {'ForeName': 'Hongkun', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Chuangxin', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Zhong', 'Affiliation': ''}, {'ForeName': 'Yajun', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'Longhui', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Fabao', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Chenjin', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': ''}]",Ophthalmic research,['10.1159/000512296']
2642,33053570,Analysis of the Endometrial Transcriptome at the Time of Implantation in Women Receiving a Single Post-Ovulatory Dose of Levonorgestrel or Mifepristone.,"BACKGROUND


Levonorgestrel (LNG) is a progesterone receptor agonist used in both regular and emergency hormonal contraception; however, its effects on the endometrium as a contraceptive remain widely unknown and under public debate.
OBJECTIVE


To analyze the effects of LNG or mifepristone (MFP), a progesterone receptor antagonist and also known as RU-486, administered at the time of follicle rupture (FR) on endometrial transcriptome during the receptive period of the menstrual cycle.
METHODS


Ten volunteers ovulatory women were studied during two menstrual cycles, a control cycle and a consecutively treated cycle; in this last case, women were randomly allocated to two groups of 5 women each, receiving one dose of LNG (1.5 mg) or MFP (50 mg) the day of the FR by ultrasound. Endometrial biopsies were taken 6 days after drug administration and prepared for microarray analysis.
RESULTS


Genomic functional analysis in the LNG-treated group showed as activated the bio-functions embryo implantation and decidualization, while these bio-functions in the T-MFP group were predicted as inhibited.
CONCLUSIONS


The administration of LNG as a hormonal emergency contraceptive resulted in an endometrial gene expression profile associated with receptivity. These results agree on the concept that LNG does not affect endometrial receptivity and/or embryo implantation when used as an emergency contraceptive.",2020,"RESULTS


Genomic functional analysis in the LNG-treated group showed as activated the bio-functions embryo implantation and decidualization, while these bio-functions in the T-MFP group were predicted as inhibited.
",['Ten volunteers ovulatory women'],"['Levonorgestrel or Mifepristone', 'LNG', 'MFP', 'Levonorgestrel (LNG', 'LNG or mifepristone (MFP']",['endometrial receptivity and/or embryo implantation'],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}]","[{'cui': 'C0029976', 'cui_str': 'Implantation in uterus'}]",10.0,0.0828767,"RESULTS


Genomic functional analysis in the LNG-treated group showed as activated the bio-functions embryo implantation and decidualization, while these bio-functions in the T-MFP group were predicted as inhibited.
","[{'ForeName': 'Ana E', 'Initials': 'AE', 'LastName': 'Barrios-Hernández', 'Affiliation': 'Department of Reproductive Biology Dr. Carlos Gual Castro, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Durand-Carbajal', 'Affiliation': 'Department of Reproductive Biology Dr. Carlos Gual Castro, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Claudia C', 'Initials': 'CC', 'LastName': 'Vega', 'Affiliation': 'Department of Reproductive Biology Dr. Carlos Gual Castro, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Larrea', 'Affiliation': 'Department of Reproductive Biology Dr. Carlos Gual Castro, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}]",Revista de investigacion clinica; organo del Hospital de Enfermedades de la Nutricion,['10.24875/RIC.20000079']
2643,33053597,Blood Pressure Response to Muscle Metaboreflex Activation is Impaired in Men Living with HIV.,"We investigated the muscle metaboreflex contribution to blood pressure response during dynamic handgrip exercise in men living with HIV (MLHIV) vs. without HIV (Controls). Pressor and heart rate responses were evaluated during metaboreflex activation through post-exercise muscle ischemia (PEMI) method and control exercise session (CER) in 17 MLHIV and 21 Controls. Protocols were performed randomly on the same day, being both sessions composed of 12 min, as follows: a) 3 min at rest, b) 3 min of dynamic handgrip exercise at 30% of maximal voluntary contraction, c) 3 min of recovery post-exercise with vascular occlusion (occlusion only in PEMI), and d) 3 min of recovery post-exercise without vascular occlusion. To assess metaboreflex response, differences between PEMI and CER in recovery post-exercise were calculated for blood pressure and heart rate. Systolic and mean blood pressure (P<0.01) were superior in the last 2 min of recovery with vascular occlusion at PEMI in relation to CER for both groups. No difference was found between groups for blood pressure and heart rate (P>0.05). However, metaboreflex response for systolic blood pressure was lower in MLHIV vs. Controls (4.05±4.63 vs. 7.61±3.99 mmHg; P=0.01). In conclusion, pressor response during metaboreceptor stimulation was attenuated in men living with HIV, which may suggest loss of muscle metaboreflex sensibility.",2020,Systolic and mean blood pressure (P<0.01) were superior in the last 2 min of recovery with vascular occlusion at PEMI in relation to CER for both groups.,"['men living with HIV', '17 MLHIV and 21 Controls', 'men living with HIV (MLHIV) vs. without HIV (Controls', 'Men Living with HIV']","['dynamic handgrip exercise at 30% of maximal voluntary contraction, c) 3\u2009min of recovery post-exercise with vascular occlusion (occlusion only in PEMI), and d) 3\u2009min of recovery post-exercise without vascular occlusion', 'metaboreflex activation through post-exercise muscle ischemia (PEMI) method and control exercise session (CER', 'dynamic handgrip exercise']","['blood pressure and heart rate', 'metaboreflex response', 'pressor response', 'Pressor and heart rate responses', 'metaboreflex response for systolic blood pressure', 'Blood Pressure Response', 'Systolic and mean blood pressure']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C1096458', 'cui_str': 'Vascular occlusion'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237504', 'cui_str': 'CER'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",,0.101859,Systolic and mean blood pressure (P<0.01) were superior in the last 2 min of recovery with vascular occlusion at PEMI in relation to CER for both groups.,"[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Gama', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State, Rio de Janeiro, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Farinatti', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State, Rio de Janeiro, Brazil.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Crisafulli', 'Affiliation': 'Department of Medical Science and Public Health, University of Cagliari, Italy.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Borges', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State, Rio de Janeiro, Brazil.'}]",International journal of sports medicine,['10.1055/a-1263-1124']
2644,33053609,Application of ultrasound-guided seminal vesicle radiography combining CT three-dimensional reconstruction technique in transurethral seminal vesiculoscopy.,"For the treatment of ejaculatory duct obstruction, transurethral seminal vesiculoscopy (TSV) is the most common method, but the success rate is much lower than studies that have reported. So we developed a new ultrasound-guided seminal vesicle radiography (UGSVR) combining CT three-dimensional reconstruction (CT-TR) technique to improve the success rate of TSV. Between June 2018 and November 2019, 32 patients were enrolled and randomly assigned to two groups: experimental group (UGSvR combining CT-TR) and control group (standard evaluation). Baseline information, including age, smoking history and body mass index (BMI), was compared preoperatively. Surgical parameters included success rates (SR), surgical time (ST), catheter days (CD), length of hospital stays (HS) and complications were compared between groups. There were no statistically significant differences in baseline data between the two groups (all p > .05). There were no significant differences in the CD, HS and complications between the two groups (all p > .05), but the differences in ST and SR were statistically significant (p < .05). In conclusion, this new technique of UGSvR combining CT-TR was achieving a satisfactory increase in the success rate of TSV, while not increasing the incidence of complications, compared to normal evaluation before TSV operation.",2020,"There were no significant differences in the CD, HS and complications between the two groups (all p > .05), but the differences in ST and SR were statistically significant (p < .05).","['Between June 2018 and November 2019, 32 patients', 'transurethral seminal vesiculoscopy']","['experimental group (UGSvR combining CT-TR) and control group (standard evaluation', 'new ultrasound-guided seminal vesicle radiography (UGSVR) combining CT three-dimensional reconstruction (CT-TR) technique', 'transurethral seminal vesiculoscopy (TSV', 'ultrasound-guided seminal vesicle radiography combining CT three-dimensional reconstruction technique']","['success rates (SR), surgical time (ST), catheter days (CD), length of hospital stays (HS) and complications', 'CD, HS and complications', 'success rate of TSV', 'ST and SR', 'age, smoking history and body mass index (BMI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036628', 'cui_str': 'Seminal vesicle structure'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",32.0,0.0189879,"There were no significant differences in the CD, HS and complications between the two groups (all p > .05), but the differences in ST and SR were statistically significant (p < .05).","[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Pang', 'Affiliation': 'Department of Urology, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Lou', 'Affiliation': 'Department of Ultrasound, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Yayong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Computed Tomography, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Hao', 'Affiliation': 'Department of Urology, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Zhenduo', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Department of Urology, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Guanghui', 'Initials': 'G', 'LastName': 'Zang', 'Affiliation': 'Department of Urology, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'Department of Pediatrics, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Conghui', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Department of Urology, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}]",Andrologia,['10.1111/and.13845']
2645,33064207,The effects of a novel herbal toothpaste on salivary lactate dehydrogenase as a measure of cellular integrity.,"OBJECTIVE


Lactate dehydrogenase (LDH) is a critical intracellular enzyme responsible for anaerobic respiration in pyruvate metabolism which becomes detectable in extracellular spaces after cellular breakdown. This clinical investigation examined the effects of brushing with a test toothpaste containing natural ingredients, i.e., clove (Syzygium aromaticum), aloe vera (Aloe barbadensis), amla (Emblica officinalis), neem (Azadirachta indica), tulsi (Ocimum basillicum), and honey (from Apis mellifera), and 0.96% zinc (zinc oxide, zinc citrate) and 0.76% SMFP (1000 ppm F) in a calcium carbonate base formulated with natural ingredients (Ved Shakti, Colgate Palmolive India) and a fluoride toothpaste containing 0.76% SMFP (1000 ppm F) in a calcium carbonate base (Colgate Cavity Protection, Colgate Palmolive; henceforth control) on salivary LDH in conjunction with the assessments of dental plaque and gingivitis representing oral hygiene parameters.
MATERIALS AND METHODS


This double-blind, two-cell study enrolled 70 adults (age range 20-59 years). Subjects completed a washout and provided baseline saliva samples for LDH analysis and clinical assessments of dental plaque and gingivitis using the Turesky Modification of Quigley-Hein and Loe-Silness methods respectively. Subjects were randomly assigned to brush their teeth with either the test or control. Post-treatment sample collection and clinical evaluations were conducted after 3 weeks, 6 weeks, and 12 week sof brushing with all assessments conducted 12 h after hygiene. Statistical analyses were conducted independently for each parameter by t-test for within treatment evaluation and analysis of covariance (ANCOVA) for between treatment comparisons.
RESULTS


At baseline, treatment groups demonstrated no significant differences for LDH or dental plaque and gingival index scores. Brushing with the test demonstrated progressive reductions in salivary LDH, plaque and gingival index scores over the study duration in comparison to the control. The test demonstrated reductions in LDH of 9.5-15.4% over the study period in comparison to the control representing statistically significant effects (p < 0.05). The test also demonstrated reductions in dental plaque that ranged between 6.4 and 16.2% over the study period and gingivitis reductions that ranged between 8.2 and 23.8% representing statistically significant results (p < 0.05).
CONCLUSIONS


Brushing with a novel herbal toothpaste demonstrated significant reductions in salivary LDH representing improvements in cellular integrity with concurrent reductions in dental plaque and gingivitis as compared to the control dentifrice.
CLINICAL RELEVANCE


Salivary LDH measurements offer a non-invasive and objective measurement of mucosal cellular integrity complementing other evaluations and clinical assessments such as plaque and gingival index scores.",2020,"Brushing with the test demonstrated progressive reductions in salivary LDH, plaque and gingival index scores over the study duration in comparison to the control.",['70 adults (age range 20-59 years'],"['novel herbal toothpaste', 'calcium carbonate base (Colgate Cavity Protection, Colgate Palmolive; henceforth control', 'toothpaste containing natural ingredients, i.e., clove (Syzygium aromaticum), aloe vera (Aloe barbadensis), amla (Emblica officinalis), neem (Azadirachta indica), tulsi (Ocimum basillicum), and honey (from Apis mellifera), and 0.96% zinc (zinc oxide, zinc citrate) and 0.76% SMFP', 'fluoride toothpaste containing 0.76% SMFP']","['gingivitis reductions', 'plaque and gingival index scores', 'dental plaque', 'salivary lactate dehydrogenase', 'LDH', 'salivary LDH, plaque and gingival index scores', 'LDH or dental plaque and gingival index scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2345900', 'cui_str': 'Colgate'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0009076', 'cui_str': 'Clove'}, {'cui': 'C1658087', 'cui_str': 'Syzygium aromaticum'}, {'cui': 'C0718405', 'cui_str': 'Aloe vera'}, {'cui': 'C0969742', 'cui_str': 'Amla'}, {'cui': 'C1095052', 'cui_str': 'Melia azadirachta'}, {'cui': 'C0522470', 'cui_str': 'Ocimum'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0323351', 'cui_str': 'Apis mellifera'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0043491', 'cui_str': 'Zinc Oxide'}, {'cui': 'C0772239', 'cui_str': 'ZINC CITRATE'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}]","[{'cui': 'C0008684', 'cui_str': 'Chronic gingivitis'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}]",70.0,0.0776068,"Brushing with the test demonstrated progressive reductions in salivary LDH, plaque and gingival index scores over the study duration in comparison to the control.","[{'ForeName': 'Prem K', 'Initials': 'PK', 'LastName': 'Sreenivasan', 'Affiliation': 'Department of Oral Biology, Rutgers School of Dental Medicine, Newark, NJ, 07103, USA.'}, {'ForeName': 'Veera Venkata Prasad', 'Initials': 'VVP', 'LastName': 'Kakarla', 'Affiliation': 'Public Health Dentistry SDM College of Dental Sciences and Hospital SDM College of Dental Sciences & Hospital, Affiliated to SDM University, Dharwad, Karnataka, India. kakarlap@hotmail.com.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Sharda', 'Affiliation': 'Public Health Dentistry SDM College of Dental Sciences and Hospital SDM College of Dental Sciences & Hospital, Affiliated to SDM University, Dharwad, Karnataka, India.'}, {'ForeName': 'Yogitha', 'Initials': 'Y', 'LastName': 'Setty', 'Affiliation': 'Public Health Dentistry SDM College of Dental Sciences and Hospital SDM College of Dental Sciences & Hospital, Affiliated to SDM University, Dharwad, Karnataka, India.'}]",Clinical oral investigations,['10.1007/s00784-020-03623-8']
2646,33064247,A Contrastive Analysis of Emotional Terms in Bed-Night Stories Across Two Languages: Does it Affect Learners' Pragmatic Knowledge of Controlling Emotions? Seeking Implications to Teach English to EFL Learners.,"The present investigation aimed at studying emotional terms (ETs) in Persian and English bed-night stories for children by adopting a contrastive analysis approach within two phases. Emotional terms were categorized into two theoretical models (tokens and types) in phase one of the study, and in the second phase, the effect of teaching emotive narratives on learners' pragmatic knowledge of controlling emotions was scrutinized. To this aim, 30 English bed-night stories (15 in English and 15 in Persian) with similar lengths and difficulty levels were selected randomly. In the first phase of the study, the frequency of occurrence of emotional terms (ETs) in English and Persian English bed-night stories were compared. The results indicated that there were not statistically significant differences between the two groups of stories in terms of the emotion tokens utilized in both languages. Nevertheless, there was a major disparity in the number of ETs found in English and Persian bed-night tales concerning various types of emotions. During the second phase of the study, a group of 25 EFL learners were explicitly taught emotive English bed-night tales. A pre-test post-test design using a Discourse Completion Test was used to seek the efficacy of teaching ETs on the learners' pragmatic knowledge of controlling emotions. Findings showed that teaching emotive narratives enhanced students' pragmatic knowledge of emotions significantly. In light of the findings of the study, a number of conclusions are drawn and the implications are discussed.",2020,The results indicated that there were not statistically significant differences between the two groups of stories in terms of the emotion tokens utilized in both languages.,['30 English bed-night stories (15 in English and 15 in Persian) with similar lengths and difficulty levels were selected randomly'],[],['frequency of occurrence of emotional terms (ETs) in English and Persian English bed-night stories'],"[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",[],"[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]",30.0,0.0163848,The results indicated that there were not statistically significant differences between the two groups of stories in terms of the emotion tokens utilized in both languages.,"[{'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Namaziandost', 'Affiliation': 'Department of English, Shahrekord Branch, Islamic Azad University, Shahrekord, Iran. e.namazi75@yahoo.com.'}, {'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Razmi', 'Affiliation': 'Foreign Languages Department, Yazd University, Yazd, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Heidari', 'Affiliation': 'Department of Literature and Humanities, Razi University of Kermanshah, Kermanshah, Iran.'}, {'ForeName': 'Shouket Ahmad', 'Initials': 'SA', 'LastName': 'Tilwani', 'Affiliation': 'Department of English, College of Science and Humanities, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}]",Journal of psycholinguistic research,['10.1007/s10936-020-09739-y']
2647,33064250,A Coloured Pen Needle Education System Improves Insulin Site Rotation Habits: Results of a Randomized Study.,"INTRODUCTION


Needle reuse and repeated injection of insulin into the same site encourage lipohypertrophy. We explored the potential of coupling a novel pen needle strategy with community pharmacists to improve injection site rotation.
METHODS


Between October 2018 and January 2019, adult insulin users with type 1 or 2 diabetes were enrolled by 16 community pharmacists across 7 Canadian provinces and randomized to their usual pen needles (control) or coloured pen needles packaged with education materials in boxes with reminder sound chips (intervention [mCPN]). A total of 203 individuals completed all requirements of the 30-day study. The primary outcome was a composite of the number of zones injected, the use of new injection zones if the number of zones equaled that at baseline, and the change in size of the injection area from baseline. The pharmacists completed two questionnaires, which provided insights into whether study participation elevated their comfort and confidence in providing injection site rotation counselling.
RESULTS


Compared to the control group, more participants in the mCPN arm improved their site rotation practices (54.1% vs. 33.7%; P = 0.005), 15 more increased the number of injection zones used (P = 0.03), and there was less needle reuse (25% vs. 12% reduction). The pharmacists reported improved knowledge of the consequences of lipohypertrophy and the proportion who were ""very comfortable"" with pen needle tip selection and use rose from 31.3% pre-study to 93.8% post-study.
CONCLUSION


The coloured pen needles with their education materials are a novel means of encouraging injection site rotation. Community pharmacists represent an untapped resource for improving injection self-care practices.",2020,"The pharmacists reported improved knowledge of the consequences of lipohypertrophy and the proportion who were ""very comfortable"" with pen needle tip selection and use rose from 31.3% pre-study to 93.8% post-study.
","['Between October 2018 and January 2019', 'adult insulin users with type 1 or 2 diabetes were enrolled by 16 community pharmacists across 7 Canadian provinces and randomized to their', '203 individuals completed all requirements of the 30-day study']",['usual pen needles (control) or coloured pen needles packaged with education materials in boxes with reminder sound chips (intervention [mCPN'],"['needle reuse', 'number of injection zones', 'Insulin Site Rotation Habits', 'site rotation practices', 'composite of the number of zones injected, the use of new injection zones if the number of zones equaled that at baseline, and the change in size of the injection area from baseline']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0402003', 'cui_str': 'Community pharmacist'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0070220', 'cui_str': 'penclomedine'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",203.0,0.0486174,"The pharmacists reported improved knowledge of the consequences of lipohypertrophy and the proportion who were ""very comfortable"" with pen needle tip selection and use rose from 31.3% pre-study to 93.8% post-study.
","[{'ForeName': 'Lori D', 'Initials': 'LD', 'LastName': 'Berard', 'Affiliation': 'Nurse Consultant, Winnipeg, Manitoba, Canada. ldberard@gmail.com.'}, {'ForeName': 'Sherri A', 'Initials': 'SA', 'LastName': 'Pockett', 'Affiliation': 'St. Boniface General Hospital, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Roscoe', 'Affiliation': 'R2 Consulting Ltd, Diabetes Education Centre, Saint John Regional Hospital, Saint John, New Brunswick, Canada.'}, {'ForeName': 'Rick L', 'Initials': 'RL', 'LastName': 'Siemens', 'Affiliation': 'London Drugs Pharmacy, Lethbridge, Alberta, Canada.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00939-2']
2648,33064290,Improving health-related quality of life and adherence to health-promoting behaviors among coronary artery bypass graft patients: a non-randomized controlled trial study.,"PURPOSE


This study aimed to determine the impact of a healthy lifestyle empowerment program on health-related quality of life and adherence to health-promoting behaviors in coronary artery bypass graft patients.
METHODS


This non-randomized controlled trial was conducted in 2019 on 97 coronary artery bypass graft patients in Iran. Participants were selected by culturally pragmatic and non-randomized method and assigned to healthy lifestyle empowerment program group (HLEPG) (n = 49) and conventional education group (CEG) (n = 48). Data were collected by the 12-item short-form health survey (SF-12) and health-promoting lifestyle profile II (HPLP2), which were administered at baseline and three-month follow-up. The healthy lifestyle empowerment program and conventional education as two interventions were performed for HLEPG and CEG, respectively. Data analysis was performed using the paired t-test, independent t-test, analysis of covariance and linear mixed method at the 0.05 significance level.
RESULTS


In the follow-up, both groups showed a significant increase in the mean score of health-related quality of life (p ≤ 0.001) but this increase was visibly greater in the HLEPG (from 23.47 ± 7.48 to 35.60 ± 5.95) than in the CEG (from 22.93 ± 5.93 to 27.6 ± 4.90). The healthy lifestyle empowerment program also significantly increased the mean score of adherence to health-promoting behaviors in the HLEPG (p ≤ 0.001), whereas no such change was observed in the CEG. The results of the linear mixed model showed that the follow-up scores health-related quality of life and adherence to health-promoting behaviors of the HLEPG were 27.26 and 7.56 units significantly greater than the CEG after HLEP, respectively (p < 0.001).
CONCLUSION


Considering the results of this study, health care providers are recommended to devise and implement healthy lifestyle empowerment programs to improve the health-related quality of life of coronary artery bypass surgery patients.
CLINICAL TRIAL REGISTRATION


Registered at Iranian Registry of Clinical Trials (IRCT20171213037860N1).",2020,"In the follow-up, both groups showed a significant increase in the mean score of health-related quality of life (p ≤ 0.001) but this increase was visibly greater in the HLEPG (from 23.47 ± 7.48 to 35.60 ± 5.95) than in the CEG (from 22.93 ± 5.93 to 27.6 ± 4.90).","['coronary artery bypass surgery patients', '2019 on 97 coronary artery bypass graft patients in Iran', 'coronary artery bypass graft patients']","['HLEPG', 'healthy lifestyle empowerment program', 'healthy lifestyle empowerment program group (HLEPG) (n\u2009=\u200949) and conventional education group (CEG']","['mean score of health-related quality of life', '12-item short-form health survey (SF-12) and health-promoting lifestyle profile II (HPLP2', 'mean score of adherence to health-promoting behaviors', 'Improving health-related quality of life and adherence to health-promoting behaviors', 'health-related quality of life and adherence to health-promoting behaviors', 'scores health-related quality of life and adherence to health-promoting behaviors of the HLEPG']","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0150375', 'cui_str': 'Group education'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",,0.0846604,"In the follow-up, both groups showed a significant increase in the mean score of health-related quality of life (p ≤ 0.001) but this increase was visibly greater in the HLEPG (from 23.47 ± 7.48 to 35.60 ± 5.95) than in the CEG (from 22.93 ± 5.93 to 27.6 ± 4.90).","[{'ForeName': 'Shabnam', 'Initials': 'S', 'LastName': 'Zafari Nobari', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Niayesh Cross Road, Tehran, Iran.'}, {'ForeName': 'Parvaneh', 'Initials': 'P', 'LastName': 'Vasli', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Niayesh Cross Road, Tehran, Iran. p-vasli@sbmu.ac.ir.'}, {'ForeName': 'Meimanat', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Niayesh Cross Road, Tehran, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'Department of Basic Sciences, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02675-3']
2649,33064415,Exercise for Weight Loss: Further Evaluating Energy Compensation with Exercise.,"PURPOSE


This study assessed how individuals compensate for energy expended during a 12-wk aerobic exercise intervention, elucidating potential mechanisms and the role exercise dose plays in the compensatory response.
PARTICIPANTS AND DESIGN


Three-arm, randomized controlled trial among sedentary adults age 18 to 40 yr, body mass index of 25 to 35. Groups included six exercise sessions per week, two sessions per week, and sedentary control.
METHODS


Rate of exercise energy expenditure was calculated from a graded exercise test averaged across five heart rate zones. Energy compensation was calculated as the difference between expected weight loss (based on exercise energy expenditure) and changes in fat and fat-free mass (DXA). Resting energy expenditure was assessed via indirect calorimetry and concentrations of acylated ghrelin, leptin, insulin, and Glucagon-like peptide 1 (GLP-1) were assessed fasting and postprandial (six timepoints over 2 h).
RESULTS


The 6-d·wk group expended more energy (2753.5 kcal) and exercised longer (320.5 min) per week than the 2-d·wk group (1490.7 kcal, 1888.8 min, P < 0.05), resulting in greater fat loss compared with the 2-d or control groups (P < 0.05). Exercise groups did not differ in the % or total kcal compensated. Greater decreases in area under the curve (AUC) for acylated ghrelin predicted greater fat loss, regardless of group, energy expended per week, exercise duration, or exercise intensity. Changes in leptin AUC was the only independent predictor for energy compensation, with a greater decrease in leptin AUC predicting less energy compensation. Exercise frequency, energy expended, duration, or intensity did not influence energy compensation.
CONCLUSIONS


Leptin is an important factor in successful weight loss through exercise, with greater postprandial decreases promoting less compensation. Greater amounts of exercise do not influence the compensatory response to an exercise-induced energy deficit.",2020,"Greater decreases in area under the curve (AUC) for acylated ghrelin predicted greater fat loss, regardless of group, energy expended per week, exercise duration, or exercise intensity.","['sedentary adults age 18 to 40 yr, body mass index of 25 to 35']",['aerobic exercise intervention'],"['weight loss', 'greater fat loss', 'area under the curve (AUC', 'fat loss, regardless of group, energy expended per week, exercise duration, or exercise intensity', 'Energy compensation', 'Exercise frequency, energy expended, duration, or intensity', 'Weight Loss', 'leptin AUC', 'indirect calorimetry and concentrations of acylated ghrelin, leptin, insulin, and Glucagon-like peptide 1 (GLP-1']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0556455', 'cui_str': 'Frequency of exercise'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]",,0.0556162,"Greater decreases in area under the curve (AUC) for acylated ghrelin predicted greater fat loss, regardless of group, energy expended per week, exercise duration, or exercise intensity.","[{'ForeName': 'Kyle D', 'Initials': 'KD', 'LastName': 'Flack', 'Affiliation': '1Department of Dietetics and Human Nutrition, University of Kentucky, Lexington, KY 2College of Health Sciences and Center for Muscle Biology, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Harry M', 'Initials': 'HM', 'LastName': 'Hays', 'Affiliation': ''}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Moreland', 'Affiliation': ''}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Long', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002376']
2650,33056960,[Comparative study of corneal densitometry values after posterior lamellar keratoplasty].,"Studying clinical and functional outcomes of femtosecond laser-assisted posterior lamellar keratoplasty is an actual problem in endothelial keratoplasty.
PURPOSE


To compare the values of corneal densitometry (CD) as measured by the Scheimpflug camera (Pentacam) following femtosecond laser-assisted Descemet stripping endothelial keratoplasty (DSEK) vs microkeratome-assisted Descemet Stripping Automated Endothelial Keratoplasty (DSAEK).
MATERIAL AND METHODS


The prospective single center randomized study included 37 eyes of 37 patients with Fuchs endothelial dystrophy and cataract. 20 patients underwent cataract phacoemulsification combined with Femto-DSEK; 17 patients of the control group underwent cataract phacoemulsification combined with DSAEK. Outcome measurements included optical coherence tomography of the anterior segment of the eye, endothelial microscopy and densitometry. Optical density of the cornea and its various layers: anterior layer (AL), central layer (CL), posterior layer (PL) and interface zone was assessed in the 0-2 and 2-6 mm zones. The follow-up period lasted 1 year.
RESULTS


Comparative analysis did not reveal statistically significant differences in AL, CL, and CCT values between the groups ( p >0.05). In the Femto-DSEK group, densitometry indices of the posterior layers of the cornea and the interface zone were significantly higher than in the DSAEK group ( p <0.05). Postoperative uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA) differed significantly throughout all follow-up period with DSAEK group having better results ( p <0.05). Endothelial cell density (ECD) at 12 months was higher in the Femto-DSEK group compared with the DSAEK group (65.7±7.7% and 58.5±8.1%,  p =0.02, respectively).
CONCLUSION


After one year, corneal density values (AL, CL, PL) and CCT were comparable between the groups. UCVA, BSCVA and ECD were significantly better after DSAEK.",2020,Postoperative uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA) differed significantly throughout all follow-up period with DSAEK group having better results ( p <0.05).,"['37 eyes of 37 patients with Fuchs endothelial dystrophy and cataract', '20 patients underwent']","['cataract phacoemulsification combined with DSAEK', 'cataract phacoemulsification combined with Femto-DSEK', 'Scheimpflug camera (Pentacam) following femtosecond laser-assisted Descemet stripping endothelial keratoplasty (DSEK) vs microkeratome-assisted Descemet Stripping Automated Endothelial Keratoplasty (DSAEK', 'femtosecond laser-assisted posterior lamellar keratoplasty']","['Postoperative uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA', 'Endothelial cell density (ECD', 'UCVA, BSCVA and ECD', 'densitometry indices of the posterior layers of the cornea and the interface zone', 'Optical density of the cornea and its various layers: anterior layer (AL), central layer (CL), posterior layer (PL) and interface zone', 'values of corneal densitometry (CD', 'corneal density values (AL, CL, PL) and CCT', 'AL, CL, and CCT values', 'optical coherence tomography of the anterior segment of the eye, endothelial microscopy and densitometry']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016781', 'cui_str': ""Fuchs' corneal dystrophy""}, {'cui': 'C0086543', 'cui_str': 'Cataract'}]","[{'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C2366835', 'cui_str': 'Endothelial keratoplasty'}, {'cui': 'C1719874', 'cui_str': ""Descemet's stripping endothelial keratoplasty""}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1260869', 'cui_str': 'Microkeratome'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0022591', 'cui_str': 'Lamellar keratoplasty'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0011321', 'cui_str': 'Densitometry'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}]",37.0,0.0660162,Postoperative uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA) differed significantly throughout all follow-up period with DSAEK group having better results ( p <0.05).,"[{'ForeName': 'N F', 'Initials': 'NF', 'LastName': 'Shilova', 'Affiliation': 'S.N. Fyodorov National Medical Research Center «MNTK «Eye Microsurgery», Moscow, Russia.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Anisimova', 'Affiliation': 'A.I. Yevdokimov Moscow State University of Medicine and Dentristy, Moscow, Russia.'}, {'ForeName': 'O P', 'Initials': 'OP', 'LastName': 'Antonova', 'Affiliation': 'S.N. Fyodorov National Medical Research Center «MNTK «Eye Microsurgery», Moscow, Russia.'}, {'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Anisimov', 'Affiliation': 'A.I. Yevdokimov Moscow State University of Medicine and Dentristy, Moscow, Russia.'}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Malyugin', 'Affiliation': 'S.N. Fyodorov National Medical Research Center «MNTK «Eye Microsurgery», Moscow, Russia.'}]",Vestnik oftalmologii,['10.17116/oftalma202013605125']
2651,31164431,Effect of pirfenidone on breathlessness in patients with idiopathic pulmonary fibrosis.,,2019,,['patients with idiopathic pulmonary fibrosis'],['pirfenidone'],['breathlessness'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}]","[{'cui': 'C0298067', 'cui_str': 'pirfenidone'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}]",,0.0110856,,"[{'ForeName': 'Marilyn K', 'Initials': 'MK', 'LastName': 'Glassberg', 'Affiliation': 'Miller School of Medicine, University of Miami, Miami, FL, USA mglassbe@med.miami.edu.'}, {'ForeName': 'Marlies S', 'Initials': 'MS', 'LastName': 'Wijsenbeek', 'Affiliation': 'Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Gilberg', 'Affiliation': 'F. Hoffmann-La Roche, Ltd., Basel, Switzerland.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Petzinger', 'Affiliation': 'Accovion GmbH, Eschborn, Germany.'}, {'ForeName': 'Klaus-Uwe', 'Initials': 'KU', 'LastName': 'Kirchgaessler', 'Affiliation': 'F. Hoffmann-La Roche, Ltd., Basel, Switzerland.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Albera', 'Affiliation': 'School of Medicine, Dept of Medical Sciences, University of Turin, Turin, Italy.'}]",The European respiratory journal,['10.1183/13993003.00399-2019']
2652,31189966,"Incident Hepatocellular Carcinoma Risk in Patients Treated with a Sulfonylurea: A Nationwide, Nested, Case-Control Study.","Several studies have shown that the use of sulfonylureas in patients with type 2 diabetes mellitus (T2DM) is associated with a higher risk of hepatocellular carcinoma (HCC). In this study, we investigated the effects of individual sulfonylureas on HCC development using the National Health Insurance Service-National Sample Cohort in South Korea. Among 47,738 subjects aged 40 years or older who had newly diagnosed with diabetes, 241 incident HCC cases and 1205 matched controls were identified. Adjusted odds ratios (ORs) as estimates of the relative risk of HCC were calculated using logistic regression analysis. Compared to patients never treated with a sulfonylurea, those treated with a sulfonylurea had a 1.7-fold increased risk of HCC development. Of the different types of sulfonylureas, the exclusive use of glimepiride was associated with a significantly elevated risk of HCC (OR = 1.89, 95% CI = 1.02-3.47) compared to those who were never treated with sulfonylureas. No significant associations were observed between exclusive gliclazide use and incident HCC (OR = 2.04, 95% CI = 0.75-5.52). In conclusion, the association between the use of sulfonylureas and risk of HCC was different according to the type of sulfonylurea, in patients with new-onset T2DM. Further prospective studies are warranted to confirm these results and translate them into clinical practice.",2019,"No significant associations were observed between exclusive gliclazide use and incident HCC (OR = 2.04, 95% CI = 0.75-5.52).","['patients with new-onset T2DM', '47,738 subjects aged 40 years or older who had newly diagnosed with diabetes, 241 incident HCC cases and 1205 matched controls were identified', 'National Health Insurance Service-National Sample Cohort in South Korea', 'patients with type 2 diabetes mellitus (T2DM']","['gliclazide', 'glimepiride', 'sulfonylureas', 'Sulfonylurea', 'individual sulfonylureas', 'sulfonylurea']","['risk of HCC development', 'elevated risk of HCC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205250', 'cui_str': 'High'}]",47738.0,0.0264602,"No significant associations were observed between exclusive gliclazide use and incident HCC (OR = 2.04, 95% CI = 0.75-5.52).","[{'ForeName': 'Ji-Yeon', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Suk-Yong', 'Initials': 'SY', 'LastName': 'Jang', 'Affiliation': 'Department of Preventive Medicine, Eulgi University College of Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Chung Mo', 'Initials': 'CM', 'LastName': 'Nam', 'Affiliation': 'Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea. cmnam@yuhs.ac.'}, {'ForeName': 'Eun Seok', 'Initials': 'ES', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea. edgo@yuhs.ac.'}]",Scientific reports,['10.1038/s41598-019-44447-1']
2653,31294917,A cardiovascular risk prediction model for older people: Development and validation in a primary care population.,"Cardiovascular risk prediction is mainly based on traditional risk factors that have been validated in middle-aged populations. However, associations between these risk factors and cardiovascular disease (CVD) attenuate with increasing age. Therefore, for older people the authors developed and internally validated risk prediction models for fatal and non-fatal CVD, (re)evaluated the predictive value of traditional and new factors, and assessed the impact of competing risks of non-cardiovascular death. Post hoc analyses of 1811 persons aged 70-78 year and free from CVD at baseline from the preDIVA study (Prevention of Dementia by Intensive Vascular care, 2006-2015), a primary care-based trial that included persons free from dementia and conditions likely to hinder successful long-term follow-up, were performed. In 2017-2018, Cox-regression analyses were performed for a model including seven traditional risk factors only, and a model to assess incremental predictive ability of the traditional and eleven new factors. Analyses were repeated accounting for competing risk of death, using Fine-Gray models. During an average of 6.2 years of follow-up, 277 CVD events occurred. Age, sex, smoking, and type 2 diabetes mellitus were traditional predictors for CVD, whereas total cholesterol, HDL-cholesterol, and systolic blood pressure (SBP) were not. Of the eleven new factors, polypharmacy and apathy symptoms were predictors. Discrimination was moderate (concordance statistic 0.65). Accounting for competing risks resulted in slightly smaller predicted absolute risks. In conclusion, we found, SBP, HDL, and total cholesterol no longer predict CVD in older adults, whereas polypharmacy and apathy symptoms are two new relevant predictors. Building on the selected risk factors in this study may improve CVD prediction in older adults and facilitate targeting preventive interventions to those at high risk.",2019,Accounting for competing risks resulted in slightly smaller predicted absolute risks.,"['middle-aged populations', 'older adults', 'older people', '1811 persons aged 70-78\xa0year and free from CVD at baseline from the preDIVA study (Prevention of Dementia by Intensive Vascular care, 2006-2015), a primary care-based trial that included persons free from dementia and conditions likely to hinder successful long-term follow-up, were performed']",[],"['SBP, HDL, and total cholesterol no longer predict CVD', 'total cholesterol, HDL-cholesterol, and systolic blood pressure (SBP']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]",[],"[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}]",,0.0251982,Accounting for competing risks resulted in slightly smaller predicted absolute risks.,"[{'ForeName': 'Emma F', 'Initials': 'EF', 'LastName': 'van Bussel', 'Affiliation': 'Department of General Practice, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Edo', 'Initials': 'E', 'LastName': 'Richard', 'Affiliation': 'Department of Neurology, Donderds Centre for Brain, Behaviour and Cognition, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Wim B', 'Initials': 'WB', 'LastName': 'Busschers', 'Affiliation': 'Department of General Practice, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ewout W', 'Initials': 'EW', 'LastName': 'Steyerberg', 'Affiliation': 'Department of Biomedical Data Sciences, LUMC, Leiden, The Netherlands.'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'van Gool', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Moll van Charante', 'Affiliation': 'Department of General Practice, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marieke P', 'Initials': 'MP', 'LastName': 'Hoevenaar-Blom', 'Affiliation': 'Department of Neurology, Donderds Centre for Brain, Behaviour and Cognition, Radboud University Medical Center, Nijmegen, The Netherlands.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13617']
2654,31396203,The Risk of Pulmonary Embolism in Patients With Pemphigus: A Population-Based Large-Scale Longitudinal Study.,"Growing evidence suggests that inflammation may pose an atypical risk factor for pulmonary embolism (PE), as it drives venous thrombosis via several pathways. The increased risk of PE in several autoimmune diseases has lent weight to this concept. However, the relative risk of PE among patients with pemphigus has not yet been established. We aimed to examine the risk of PE in patients with pemphigus. A large-scale population-based longitudinal cohort study was conducted to evaluate the relative risk (RR) of PE among 1,985 patients with pemphigus relative to 9,874 age-, sex-, and ethnicity-matched control subjects. A multivariate Cox regression model was utilized. The incidence of PE was 3.0 (95% CI, 2.2-4.0) and 1.2 (95% CI, 1.0-1.5) per 1,000 person-years among patients with pemphigus and controls, respectively. The period prevalence of PE corresponding to the study period was 2.2% (95% CI, 1.6-2.9%) among cases and 0.9% (95% CI, 0.7-1.1%) among controls. Patients with pemphigus were twice as likely to develop PE as compared to control subjects (adjusted RR, 1.98; 95% confidence interval [CI], 1.29-3.04). The highest PE risk was observed during the 1st year following the diagnosis of pemphigus (adjusted RR, 3.55; 95% CI, 1.78-7.09) and decreased over time. The increased risk was robust to a sensitivity analysis that included only cases managed by pemphigus-related systemic medications (adjusted RR, 1.82; 95% CI, 1.11-2.98). In conclusion, pemphigus is associated with an increased risk of PE, particularly during the 1st year of the disease. An awareness of this risk should be increased, additional precipitating factors for PE should be avoided, and thromboprophylaxis may be evaluated in high-risk patients. Further research is required to establish this risk.",2019,"Patients with pemphigus were twice as likely to develop PE as compared to control subjects (adjusted RR, 1.98; 95% confidence interval [CI], 1.29-3.04).","['1,985 patients with pemphigus relative to 9,874 age-, sex-, and ethnicity-matched control subjects', 'Patients With Pemphigus', 'patients with pemphigus']",[],"['incidence of PE', 'risk of PE', 'Risk of Pulmonary Embolism', 'highest PE risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030807', 'cui_str': 'Pemphigus'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0633091,"Patients with pemphigus were twice as likely to develop PE as compared to control subjects (adjusted RR, 1.98; 95% confidence interval [CI], 1.29-3.04).","[{'ForeName': 'Khalaf', 'Initials': 'K', 'LastName': 'Kridin', 'Affiliation': 'Department of Dermatology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Mouhammad', 'Initials': 'M', 'LastName': 'Kridin', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Kyle T', 'Initials': 'KT', 'LastName': 'Amber', 'Affiliation': 'Department of Dermatology, University of Illinois at Chicago, Chicago, IL, United States.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Shalom', 'Affiliation': ""Siaal Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben-Gurion University of the Negev, Be'er Sheva, Israel.""}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Comaneshter', 'Affiliation': ""Department of Quality Measurements and Research, Chief Physician's Office, Clalit Health Services, Tel Aviv, Israel.""}, {'ForeName': 'Erez', 'Initials': 'E', 'LastName': 'Batat', 'Affiliation': ""Department of Quality Measurements and Research, Chief Physician's Office, Clalit Health Services, Tel Aviv, Israel.""}, {'ForeName': 'Arnon D', 'Initials': 'AD', 'LastName': 'Cohen', 'Affiliation': ""Siaal Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben-Gurion University of the Negev, Be'er Sheva, Israel.""}]",Frontiers in immunology,['10.3389/fimmu.2019.01559']
2655,33053849,"Sirolimus Prolongs Survival after Living Donor Liver Transplantation for Hepatocellular Carcinoma Beyond Milan Criteria: A Prospective, Randomised, Open-Label, Multicentre Phase 2 Trial.","Sirolimus (SRL) has been reported to benefit patients undergoing liver transplantation (LT) for hepatocellular carcinoma (HCC). This study aimed to compare SRL with tacrolimus (TAC) in living-donor LT (LDLT) recipients beyond the Milan criteria. This study was initially designed to enrol 45 recipients who underwent LDLT for HCC beyond the Milan criteria. At 1 month after LT, the patients were randomly assigned to either SRL or TAC-based treatment, with both groups receiving mycophenolate mofetil. The primary outcome was three-year recurrence-free survival (RFS) and the secondary outcome was overall survival (OS). A total of 42 patients completed the study. HCC recurrence occurred in 8 of 22 (36.4%) patients in the SRL group and in 5 of 22 (25%) patients in the TAC group. No differences in RFS and OS were found between the two groups in simple comparison. The type of immunosuppressant remained a nonsignificant factor for recurrence in multivariate analysis; however, SRL significantly prolonged OS (TAC hazard ratio: 15 [1.3-172.85],  p  = 0.03) after adjusting for alpha-fetoprotein and positron emission tomography standardised uptake value ratio (tumour/background liver). In conclusion, SRL does not decrease HCC recurrence but prolongs OS after LDLT for HCC beyond the Milan criteria.",2020,No differences in RFS and OS were found between the two groups in simple comparison.,"['living-donor LT (LDLT) recipients beyond the Milan criteria', 'patients undergoing liver transplantation (LT) for hepatocellular carcinoma (HCC', '42 patients completed the study', 'enrol 45 recipients who underwent LDLT for HCC beyond the Milan criteria']","['mycophenolate mofetil', 'SRL or TAC', 'SRL with tacrolimus (TAC', 'Sirolimus (SRL', 'Living Donor Liver Transplantation', 'Sirolimus']","['year recurrence-free survival (RFS', 'RFS and OS', 'HCC recurrence', 'overall survival (OS']","[{'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",42.0,0.0965822,No differences in RFS and OS were found between the two groups in simple comparison.,"[{'ForeName': 'Kwang-Woong', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}, {'ForeName': 'Seong Hoon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Center for Liver Cancer, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si 410-769, Gyeonggi-do, Korea.'}, {'ForeName': 'Kyung Chul', 'Initials': 'KC', 'LastName': 'Yoon', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}, {'ForeName': 'Jeong-Moo', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}, {'ForeName': 'Jae-Hyung', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}, {'ForeName': 'Suk Kyun', 'Initials': 'SK', 'LastName': 'Hong', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}, {'ForeName': 'Nam-Joon', 'Initials': 'NJ', 'LastName': 'Yi', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}, {'ForeName': 'Sung-Sik', 'Initials': 'SS', 'LastName': 'Han', 'Affiliation': 'Center for Liver Cancer, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si 410-769, Gyeonggi-do, Korea.'}, {'ForeName': 'Sang-Jae', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Center for Liver Cancer, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si 410-769, Gyeonggi-do, Korea.'}, {'ForeName': 'Kyung-Suk', 'Initials': 'KS', 'LastName': 'Suh', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9103264']
2656,33053855,A Clinical Trial to Evaluate the Efficacy and Safety of 3D Printed Bioceramic Implants for the Reconstruction of Zygomatic Bone Defects.,"The purpose of this study was to evaluate the clinical efficacy and safety of patient-specific additive-manufactured CaOSiO 2 -P 2 O 5 -B 2 O 3  glass-ceramic (BGS-7) implants for reconstructing zygomatic bone defects at a 6-month follow-up. A prospective, single-arm, single-center, clinical trial was performed on patients with obvious zygoma defects who needed and wanted reconstruction. The primary outcome variable was a bone fusion between the implant and the bone evaluated by computed tomography (CT) at 6 months post surgery. Secondary outcomes, including implant immobilization, satisfaction assessment, osteolysis, subsidence of the BGS-7 implant, and safety, were assessed. A total of eight patients were enrolled in the study. Two patients underwent simultaneous reconstruction of the left and right malar defects using a BGS-7 3D printed implant. Cone beam CT analysis showed that bone fusion at 6 months after surgery was 100%. We observed that the average fusion rate was 76.97%. Osteolysis around 3D printed BGS-7 implants was not observed. The mean distance displacement of all 10 implants was 0.4149 mm. Our study showed no adverse event in any of the cases. The visual analog scale score for satisfaction was 9. All patients who enrolled in this trial were aesthetically and functionally satisfied with the surgical results. In conclusion, this study demonstrates the safety and promising value of patient-specific 3D printed BGS-7 implants as a novel facial bone reconstruction method.",2020,Osteolysis around 3D printed BGS-7 implants was not observed.,"['A total of eight patients were enrolled in the study', 'patients with obvious zygoma defects who needed and wanted reconstruction']","['BGS-7 3D printed implant', 'O 5 -B 2 O 3  glass-ceramic (BGS-7) implants', 'patient-specific additive-manufactured CaOSiO 2 -P 2', '3D Printed Bioceramic Implants']","['average fusion rate', 'bone fusion between the implant and the bone evaluated by computed tomography (CT', 'implant immobilization, satisfaction assessment, osteolysis, subsidence of the BGS-7 implant, and safety', 'mean distance displacement', 'visual analog scale score for satisfaction', 'clinical efficacy and safety']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043539', 'cui_str': 'Zygomatic bone structure'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0265308', 'cui_str': 'Baller-Gerold syndrome'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0045550', 'cui_str': '2,5-dichloro-4-bromophenol'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0442796', 'cui_str': 'Additive'}, {'cui': 'C0608663', 'cui_str': 'P-2'}]","[{'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0185364', 'cui_str': 'Osteoplasty'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4721411', 'cui_str': 'Osteolysis'}, {'cui': 'C0265308', 'cui_str': 'Baller-Gerold syndrome'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",8.0,0.0391568,Osteolysis around 3D printed BGS-7 implants was not observed.,"[{'ForeName': 'Ui-Lyong', 'Initials': 'UL', 'LastName': 'Lee', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Chung-Ang University Hospital, Soeul 06973, Korea.'}, {'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Lim', 'Affiliation': 'CGbio 3D Innovation Center, Seongnam-si 13211, Korea.'}, {'ForeName': 'Sung-Nam', 'Initials': 'SN', 'LastName': 'Park', 'Affiliation': 'CGbio 3D Innovation Center, Seongnam-si 13211, Korea.'}, {'ForeName': 'Byoung-Hun', 'Initials': 'BH', 'LastName': 'Choi', 'Affiliation': 'CGbio 3D Innovation Center, Seongnam-si 13211, Korea.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine, Seoul 06974, Korea.'}, {'ForeName': 'Won-Cheul', 'Initials': 'WC', 'LastName': 'Choi', 'Affiliation': 'Chung-Ang 3D Craniofacial Research Society, Chun-Ang University, Seoul 06974, Korea.'}]","Materials (Basel, Switzerland)",['10.3390/ma13204515']
2657,33053919,The effect of short-term creatine intake on blood lactic acid and muscle fatigue measured by accelerometer-based tremor response to acute resistance exercise.,"PURPOSE


The purpose of this study was to investigate the effects of short-term creatine intake on muscle fatigue induced by resistance exercise in healthy adolescent men, i.e., lactic acid concentration and wrist and head tremor measured by an accelerometer.
METHODS


Twelve healthy adolescent men who had no experience with creatine intake were included. The subjects were randomly assigned to the creatine group and the placebo group, followed by 5 days of creatine and placebo intake, and 5 times of 5 sets of leg press, leg extension, bench press, and arm curl exercises at 70% repetition maximum (RM). The lactic acid concentration before and after exercising, rate of perceived exertion (RPE), and accelerometer-based wrist tremor and head tremor during exercise were measured. Subsequently, after 7 days to allow for creatine washout, the same exercise treatment and measurement were performed in each group after switching drug and placebo between the groups.
RESULTS


The level of lactic acid before and after the acute resistance exercise trial was significantly lower in the creatine group than in the placebo group (P <0.05). The mean RPE during the resistance exercise was significantly lower in the creatine group than in the placebo group (P <0.05). There was no difference between the two groups in the mean wrist tremor during resistance exercise, but the mean head tremor values were significantly lower in the creatine group than in the placebo group in the arm curl, the last event of the exercise trials (P <0.05).
CONCLUSIONS


Short-term creatine intake reduces the blood fatigue factor increased by resistance exercise, and is thought to suppress fatigue, especially in the latter half of resistance exercise. Therefore, these findings indicate that short-term creatine intake can have an improved effect on anaerobic exercise performance.",2020,"There was no difference between the two groups in the mean wrist tremor during resistance exercise, but the mean head tremor values were significantly lower in the creatine group than in the placebo group in the arm curl, the last event of the exercise trials (P <0.05).
","['healthy adolescent men', 'Twelve healthy adolescent men who had no experience with creatine intake were included']","['creatine', 'placebo', 'creatine and placebo intake, and 5 times of 5 sets of leg press, leg extension, bench press, and arm curl exercises at 70% repetition maximum (RM', 'short-term creatine intake']","['blood fatigue factor', 'mean RPE during the resistance exercise', 'mean wrist tremor during resistance exercise', 'anaerobic exercise performance', 'lactic acid concentration', 'lactic acid concentration and wrist and head tremor', 'rate of perceived exertion (RPE), and accelerometer-based wrist tremor and head tremor during exercise', 'blood lactic acid and muscle fatigue', 'level of lactic acid', 'mean head tremor values']","[{'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0239882', 'cui_str': 'Head tremor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0853170', 'cui_str': 'Blood lactic acid'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",12.0,0.0993738,"There was no difference between the two groups in the mean wrist tremor during resistance exercise, but the mean head tremor values were significantly lower in the creatine group than in the placebo group in the arm curl, the last event of the exercise trials (P <0.05).
","[{'ForeName': 'Sinwook', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Education, Korea University, SeoulRepublic of Korea.'}, {'ForeName': 'Gyuseog', 'Initials': 'G', 'LastName': 'Hong', 'Affiliation': 'Convergence Center, LG Electronics, SeoulRepublic of Korea.'}, {'ForeName': 'Wonil', 'Initials': 'W', 'LastName': 'Park', 'Affiliation': 'Department of Physical Education, Korea University, SeoulRepublic of Korea.'}, {'ForeName': 'Jaeseong', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Education, Korea University, SeoulRepublic of Korea.'}, {'ForeName': 'Nahyun', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Education, Korea University, SeoulRepublic of Korea.'}, {'ForeName': 'Hyejoon', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Physical Education, Korea University, SeoulRepublic of Korea.'}, {'ForeName': 'Jonghoon', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Physical Education, Korea University, SeoulRepublic of Korea.'}]",Physical activity and nutrition,['10.20463/pan.2020.0006']
2658,33053920,"The effects of elastic band exercises and nutritional education on frailty, strength, and nutritional intake in elderly women.","PURPOSE


The purpose of this study was to examine the effects of elastic band exercises and nutritional education, as well as to identify the factors influencing frailty, strength, and nutritional intake of elderly women.
METHODS


The subjects in this study were 30 elderly women who were divided into four groups. All groups agreed to participate in four programs: health education only (HE), elastic band exercises only (EX), nutritional education only (NU), and elastic band exercises plus nutritional education (EX+NU). Frailty was evaluated by measuring the frailty factors according to Fried et al. Leg strength was measured using a leg-extension machine. Nutritional intake was assessed by the 24-hour recall method and food records. Nutritional intake was analyzed by CAN Pro 5.0 program.
RESULTS


After three months, the prevalence of frailty significantly decreased in the EX+NU group (P=0.013) compared with that of the HE group (P=0.088). There was significant improvement in leg strength in both the EX (P=0.012) and EX+NU groups (P=0.003) compared with that of the HE group (EX, P=0.005; EX+NU, P=0.002). The nutritional intake significantly decreased in the EX group compared with that of the HE group (P<0.05, P<0.05).
CONCLUSIONS


The combination of elastic exercises and nutrition education had positive effects on frailty and leg strength, while having negative effects on total calories, carbohydrate, sodium, and iron intake in elderly women. Elastic exercises only had positive effects on leg strength while having negative effects on nutritional intake in elderly women.",2020,"There was significant improvement in leg strength in both the EX (P=0.012) and EX+NU groups (P=0.003) compared with that of the HE group (EX, P=0.005; EX+NU, P=0.002).","['30 elderly women who were divided into four groups', 'elderly women']","['health education only (HE), elastic band exercises only (EX), nutritional education only (NU), and elastic band exercises plus nutritional education (EX+NU', 'elastic exercises and nutrition education', 'Elastic exercises', 'EX+NU', 'elastic band exercises and nutritional education']","['leg strength', 'Leg strength', 'prevalence of frailty', 'total calories, carbohydrate, sodium, and iron intake', 'frailty, strength, and nutritional intake', 'frailty and leg strength', 'nutritional intake', 'Nutritional intake']","[{'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0518043', 'cui_str': 'Iron intake'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",30.0,0.0133357,"There was significant improvement in leg strength in both the EX (P=0.012) and EX+NU groups (P=0.003) compared with that of the HE group (EX, P=0.005; EX+NU, P=0.002).","[{'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Bong', 'Affiliation': 'Health and Exercise Science Laboratory, Institute of Sports Science, Seoul National University, SeoulRepublic of Korea.'}, {'ForeName': 'Wook', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Health and Exercise Science Laboratory, Institute of Sports Science, Seoul National University, SeoulRepublic of Korea.'}]",Physical activity and nutrition,['10.20463/pan.2020.0007']
2659,33053926,Effects of leucine-enriched essential amino acid supplementation on muscular fatigue and inflammatory cytokines in wheelchair basketball players.,"PURPOSE


This study aimed to investigate the effects of leucine-enriched essential amino acid (LEAA) supplementation on muscle fatigue and the level of inflammatory cytokines in wheelchair basketball players after a basketball game and interval training.
METHODS


Of the ten recruited wheelchair basketball players (aged 34.5±8.9 years; lean body mass of 34.3±10.0 kg) who had spinal cord injury (SCI) and had undergone amputation, nine participated in the final test. These nine athletes received LEAA supplements (3 times 4.0 g/day) or placebo treatment in a double-blind, randomized, crossover study. We measured variables related to muscular fatigue and inflammatory response before the intense exercise and 4 days after recovery.
RESULTS


The significant effect of LEAA supplementation was inhibition of circulating IL-6 levels in the LEAA-treated group compared with the placebo group (P < .05). However, no changes were observed in the TNF-α and creatinine kinase levels. Moreover, analysis of variance analysis showed no significant difference in the relative values of muscle soreness. However, the effect size analysis with Cohen's d reported a significant improvement in the relative values of whole body and back muscle soreness.
CONCLUSIONS


Our results revealed that LEAA supplementation before and after intense exercise could help reduce muscle soreness and IL-6 levels in wheelchair basketball players.",2020,Our results revealed that LEAA supplementation before and after intense exercise could help reduce muscle soreness and IL-6 levels in wheelchair basketball players.,"['Of the ten recruited wheelchair basketball players (aged 34.5±8.9 years; lean body mass of 34.3±10.0 kg) who had spinal cord injury (SCI) and had undergone amputation, nine participated in the final test', 'wheelchair basketball players after a basketball game and interval training', 'wheelchair basketball players']","['leucine-enriched essential amino acid supplementation', 'LEAA supplements', 'LEAA', 'leucine-enriched essential amino acid (LEAA) supplementation', 'placebo']","['TNF-α and creatinine kinase levels', 'muscular fatigue and inflammatory cytokines', 'relative values of whole body and back muscle soreness', 'muscle soreness and IL-6 levels', 'relative values of muscle soreness', 'muscular fatigue and inflammatory response', 'circulating IL-6 levels', 'muscle fatigue and the level of inflammatory cytokines']","[{'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0556083', 'cui_str': 'Essential amino acid supplementation'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0205345', 'cui_str': 'Relative'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0224334', 'cui_str': 'Skeletal muscle structure of back'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}]",10.0,0.537494,Our results revealed that LEAA supplementation before and after intense exercise could help reduce muscle soreness and IL-6 levels in wheelchair basketball players.,"[{'ForeName': 'Young Hwan', 'Initials': 'YH', 'LastName': 'An', 'Affiliation': 'Department of Physical Education, Konkuk University, SeoulRepublic of Korea.'}, {'ForeName': 'Jisu', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Sports Medicine and Science in Graduate School, Konkuk University, SeoulRepublic of Korea.'}, {'ForeName': 'Hee-Jae', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Physical Activity and Performance Institute, Konkuk University, SeoulRepublic of Korea.'}, {'ForeName': 'Kiwon', 'Initials': 'K', 'LastName': 'Lim', 'Affiliation': 'Department of Physical Education, Konkuk University, SeoulRepublic of Korea.'}]",Physical activity and nutrition,['10.20463/pan.2020.0013']
2660,33053953,"Decision-Making Visual Aids for Late, Imaging-Guided Endovascular Thrombectomy for Acute Ischemic Stroke.","BACKGROUND AND PURPOSE


Speedy decision-making is important for optimal outcomes from endovascular thrombectomy (EVT) for acute ischemic stroke (AIS). Figural decision aids facilitate rapid review of treatment benefits and harms, but have not yet been developed for late-presenting patients selected for EVT based on multimodal computed tomography or magnetic resonance imaging.
METHODS


For combined pooled study-level randomized trial (DAWN and DEFUSE 3) data, as well as each trial singly, 100 person-icon arrays (Kuiper-Marshall personographs) were generated showing beneficial and adverse effects of EVT for patients with AIS and large vessel occlusion using automated (algorithmic) and expert-guided joint outcome table specification.
RESULTS


Among imaging-selected patients 6 to 24 hours from last known well, for the full 7-category modified Rankin Scale (mRS), EVT had number needed to treat to benefit 1.9 (interquartile range [IQR], 1.9 to 2.1) and number needed to harm 40.0 (IQR, 29.2 to 58.3). Visual displays of treatment effects among 100 patients showed that, with EVT: 52 patients have better disability outcome, including 32 more achieving functional independence (mRS 0 to 2); three patients have worse disability outcome, including one more experiencing severe disability or death (mRS 5 to 6), mediated by symptomatic intracranial hemorrhage and infarct in new territory. Similar features were present in person-icon figures based on a 6-level mRS (levels 5 and 6 combined) rather than 7-level mRS, and based on the DAWN trial alone and DEFUSE 3 trial alone.
CONCLUSIONS


Personograph visual decision aids are now available to rapidly educate patients, family, and healthcare providers regarding benefits and risks of EVT for late-presenting, imaging-selected AIS patients.",2020,"RESULTS


Among imaging-selected patients","['100 patients', '100 person-icon arrays (Kuiper-Marshall personographs', 'patients with AIS and large vessel occlusion using automated (algorithmic) and expert-guided joint outcome table specification', 'Acute Ischemic Stroke']",['endovascular thrombectomy (EVT'],"['symptomatic intracranial hemorrhage and infarct in new territory', 'disability outcome', 'severe disability or death']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0243020', 'cui_str': 'Immunoconjugate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039224', 'cui_str': 'Table'}]","[{'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0524613', 'cui_str': 'New Territories'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.207436,"RESULTS


Among imaging-selected patients","[{'ForeName': 'Pouria', 'Initials': 'P', 'LastName': 'Moshayedi', 'Affiliation': 'Department of Neurology and Comprehensive Stroke Center, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Liebeskind', 'Affiliation': 'Department of Neurology and Comprehensive Stroke Center, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Jadhav', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Jahan', 'Affiliation': 'Department of Radiology and Comprehensive Stroke Center, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Lansberg', 'Affiliation': 'Department of Neurology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Latisha', 'Initials': 'L', 'LastName': 'Sharma', 'Affiliation': 'Department of Neurology and Comprehensive Stroke Center, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Raul G', 'Initials': 'RG', 'LastName': 'Nogueira', 'Affiliation': 'Department of Neurology, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Saver', 'Affiliation': 'Department of Neurology and Comprehensive Stroke Center, University of California Los Angeles, Los Angeles, CA, USA.'}]",Journal of stroke,['10.5853/jos.2019.03503']
2661,33054003,[Physical training integration with physiotherapeutic methods of myocardial metabolism recovery in the rehabilitation of patients after acute coronary syndrome and cardiosurgical myocardial revascularization].,"Successes achieved in the treatment of patients with coronary heart disease (CHD) after acute coronary syndrome and cardiosurgical interventions require the development of new, more advanced methods for their rehabilitation. This is because of metabolic disturbances persistence in the deeply ischemic myocardium in patients with coronary heart disease even after restoration of blood flow through the coronary arteries by surgical or endovascular methods due to the development of the phenomenon of «stunning» and hibernation. The discovery of the development of their own adaptation to ischemia phenomenon opens up new possibilities in the correction of the metabolism of the ischemic myocardium, which significantly increases the efficiency of patient postoperative rehabilitation.
PURPOSE OF THE STUDY


The scientific rationale for improved cardiac rehabilitation programs for patients after acute coronary syndrome and cardiac surgery.
MATERIAL AND METHODS


120 patients who were randomized to 3 groups (40 patients each) were examined: the main and two control, comparable in the major clinical manifestations of the disease. Improved methods of physical training with the inclusion of interval cyclic training for the first time in cardiology on treadmills and sensory tracks and therapeutic exercises in the gym (daily, 5 times a week, for a course of 10 procedures) were performed for patients of the 1st control group. Therapeutic procedures that improve metabolic processes in the ischemic myocardium were used in patients of the 2nd control group: enhanced external counterpulsation, general dry air carbon dioxide, infrared matrix laser therapy. Rehabilitation by the complex of the above physical training and factors which restored metabolic processes in the ischemic myocardium was carried out to patients of the main group. Methods had a cardioprotective effect and increase myocardial adaptation to ischemia.
RESULTS


The greatest anti-ischemic, antianginal, antihypoxic effects were achieved in patients of the main group compared with the control groups. What may be due to the correction of metabolic disorders and the development of cardioprotection of ischemic myocardium. The consequence is a significant increase in the rehabilitation effect of improved cardiovascular training.
CONCLUSION


The achieved result is due to the integration of improved cardiac training techniques and a procedure package aimed at cardioprotection and metabolic myocardium adaptation to ischemia, which included enhanced external counterpulsation, general dry air carbon dioxide and infrared matrix laser therapy.",2020,"The greatest anti-ischemic, antianginal, antihypoxic effects were achieved in patients of the main group compared with the control groups.","['patients with coronary heart disease', 'patients with coronary heart disease (CHD) after acute coronary syndrome and cardiosurgical interventions', 'patients after acute coronary syndrome and cardiosurgical myocardial revascularization', 'patients after acute coronary syndrome and cardiac surgery', '120 patients who were randomized to 3 groups (40 patients each']",[],"['myocardial adaptation to ischemia', 'metabolic processes', 'greatest anti-ischemic, antianginal, antihypoxic effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027056', 'cui_str': 'Myocardial revascularization'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]",[],"[{'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",120.0,0.0201528,"The greatest anti-ischemic, antianginal, antihypoxic effects were achieved in patients of the main group compared with the control groups.","[{'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Knyazeva', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology, Moscow, Russia.'}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Badtieva', 'Affiliation': 'Moscow centre for research and practice in medical, rehabilitation, restorative and sports medicine, Moscow, Russia.'}, {'ForeName': 'T I', 'Initials': 'TI', 'LastName': 'Nikiforova', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology, Moscow, Russia.'}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",['10.17116/kurort2020970515']
2662,33061673,Magnesium Sulfate Improves Some Risk Factors for Atherosclerosis in Patients Suffering from One or Two Coronary Artery Diseases: A Double-blind Clinical Trial Study.,"Purpose


Given the beneficial effect of MgSO 4  on the cardiovascular system, this study was designed to investigate the effect of MgSO 4  administration on suppressing some atherosclerotic risk factors in moderate coronary artery disease patients with one or two atherosclerotic vessels.
Patients and Methods


In a randomized double-blind placebo-controlled clinical trial study, 64 patients with moderate coronary artery disease (55-69% stenosis) were selected according to angiography findings. Patients were divided into four groups including patients with one or two atherosclerotic vessels treated with MgSO 4  (Mg-treated-VR1, Mg-treated-VR2, respectively), placebo treated patients with one or two atherosclerotic vessels (Control-VR1, Control-VR2, respectively). The patients received either placebo or MgSO 4  supplement capsule containing 300 mg MgSO 4  for six months on a daily basis. ESR, Ca/Mg ratio, urine Mg level, serum Mg, fibrinogen, homocysteine, uric acid, Na, K, Ca, CRP, T3, T4, TSH, BUN, and Cr concentrations were measured at baseline and every three months.
Results


Serum T3, Ca, K, homocysteine, CRP, and Mg concentrations were significantly improved in Mg-treated groups compared to placebo groups.
Conclusion


The results of this study showed that despite the slight change in serum magnesium level, oral administration of MgSO 4 for six months could slightly reduce the serum levels of some inflammatory and vascular factors in moderate coronary artery disease patients.",2020,"Serum T3, Ca, K, homocysteine, CRP, and Mg concentrations were significantly improved in Mg-treated groups compared to placebo groups.
","['moderate coronary artery disease patients with one or two atherosclerotic vessels', '64 patients with moderate coronary artery disease (55-69% stenosis', 'moderate coronary artery disease patients', 'Patients Suffering from One or Two Coronary Artery Diseases']","['Magnesium Sulfate', 'placebo', 'placebo or MgSO', 'atherosclerotic vessels treated with MgSO 4  (Mg-treated-VR1, Mg-treated-VR2, respectively), placebo treated patients with one or two atherosclerotic vessels (Control-VR1, Control-VR2, respectively']","['atherosclerotic risk factors', 'serum magnesium level', 'Serum T3, Ca, K, homocysteine, CRP, and Mg concentrations', 'ESR, Ca/Mg ratio, urine Mg level, serum Mg, fibrinogen, homocysteine, uric acid, Na, K, Ca, CRP, T3, T4, TSH, BUN, and Cr concentrations']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}]",64.0,0.238328,"Serum T3, Ca, K, homocysteine, CRP, and Mg concentrations were significantly improved in Mg-treated groups compared to placebo groups.
","[{'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Sobhani', 'Affiliation': 'Clinical Pathology Department, Faculty of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Farshidi', 'Affiliation': 'Cardiovascular Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Azarkish', 'Affiliation': 'Molecular Medicine Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mahdiya', 'Initials': 'M', 'LastName': 'Eslami', 'Affiliation': 'Cardiovascular Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Eftekhar', 'Affiliation': 'Endocrinology and Metabolism Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Keshavarz', 'Affiliation': 'Physiology Department, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nepton', 'Initials': 'N', 'LastName': 'Soltani', 'Affiliation': 'Physiology Department, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Clinical pharmacology : advances and applications,['10.2147/CPAA.S261264']
2663,33061677,Clinical Outcomes of a Modified Laryngeal Mask Airway (LMA ®  Gastro™ Airway) During Esophagogastroduodenoscopy in Children and Adolescents: A Randomized Study.,"Introduction


During esophagogastroduodenoscopy (EGD), general anesthesia (GA) may be provided using a laryngeal mask airway (LMA) with the endoscope inserted behind the cuff of the LMA into the esophagus. Passage of the endoscope may increase the intracuff of the LMA. We evaluated a newly designed LMA (LMA ®  Gastro™ Airway) which has an internal channel exiting from its distal end to facilitate EGD. The current study compared the change of LMA cuff pressure between this new LMA and a standard clinical LMA (Ambu ®  AuraOnce™) during EGD.
Methods


Patients less than 21 years of age and weighing more than 30 kg were randomized to receive airway management with one of the two LMAs during EGD. After anesthetic induction and successful LMA placement, the intracuff pressure of the LMAs was continuously monitored during the procedure. The primary outcome was the change of intracuff pressure of the LMAs.
Results


The study cohort included 200 patients (mean age 13.6 years and weight 56.6 kg) who were randomized to the LMA ®  Gastro™ Airway (n=100) or the Ambu ®  AuraOnce™ LMA (n=100). Average intracuff pressures during the study period (before and after endoscope insertion) were not different between the two LMAs. Ease of the procedure was slightly improved with the LMA ®  Gastro™ Airway (p<0.001).
Discussion


The LMA ®  Gastro™ Airway blunted, but did not prevent an increase in intracuff pressure during EGD when compared to the Ambu ®  AuraOnce™ LMA. Throat soreness was generally low, and complications were infrequent in both groups. The ease of the procedure was slightly improved with the LMA ®  Gastro™ Airway compared to the Ambu ®  AuraOnce™ LMA.",2020,The ease of the procedure was slightly improved with the LMA ®  Gastro™ Airway compared to the Ambu ®  AuraOnce™ LMA.,"['200 patients (mean age 13.6 years and weight 56.6 kg) who were randomized to the LMA ®  Gastro™ Airway (n=100) or the Ambu ®  AuraOnce™ LMA (n=100', 'Children and Adolescents', 'Methods\n\n\nPatients less than 21 years of age and weighing more than 30 kg']","['esophagogastroduodenoscopy (EGD), general anesthesia (GA', 'Modified Laryngeal Mask Airway (LMA ®  Gastro™ Airway', 'Esophagogastroduodenoscopy']","['Throat soreness', 'intracuff pressure of the LMAs', 'intracuff pressure', 'change of intracuff pressure of the LMAs', 'LMA cuff pressure', 'Average intracuff pressures']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]","[{'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}]",200.0,0.0542715,The ease of the procedure was slightly improved with the LMA ®  Gastro™ Airway compared to the Ambu ®  AuraOnce™ LMA.,"[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Hakim', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Bryant', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Miketic', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Nationwide Children's Hospital and the Ohio State University, Columbus, OH, USA.""}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Erdman', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Nationwide Children's Hospital and the Ohio State University, Columbus, OH, USA.""}, {'ForeName': 'Shabana Z', 'Initials': 'SZ', 'LastName': 'Shafy', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Stephani S', 'Initials': 'SS', 'LastName': 'Kim', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tobias', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}]","Medical devices (Auckland, N.Z.)",['10.2147/MDER.S272557']
2664,33061724,"Effects of Lactoferrin on Sleep Conditions in Children Aged 12-32 Months: A Preliminary, Randomized, Double-Blind, Placebo-Controlled Trial.","Purpose


To investigate preliminarily the effect of lactoferrin (LF)-fortified formula on sleep conditions in children.
Study Design


A preliminary, randomized, double-blind, placebo-controlled trial.
Methods


Healthy children between the ages of 12 and 32 months who attended nursery schools in Japan were divided into two groups and assigned a placebo or LF (48 mg/day)-fortified formula. Children's sleep conditions were investigated before and after the 13-week intervention using the Japanese Sleep Questionnaire for Preschoolers (JSQ-P).
Results


Altogether, 109 participants were randomized. Eight participants were eliminated due to lost to follow-up, withdrawal of consent, and ineligibility, with 101 participants (placebo, n = 48; LF, n = 53) included in the full analysis set (FAS) and used for analysis. Wake-up time, bedtime, and nighttime sleep were comparable between the two groups before and after intervention. The change in total JSQ-P T scores tended to improve in the LF group (placebo vs LF: 0.5 ± 6.5 vs -1.9 ± 6.1, p = 0.074), in particular, morning symptoms significantly improved (grumpy in the morning, hard to wake-up, and hard to get out of bed) (placebo vs LF: 0.8 ± 6.2 vs -1.9 ± 6.2, p = 0.028). A better trend was also observed in the LF group regarding restless legs syndrome (RLS)-motor (rubs feet at night and touches feet at night) (placebo vs LF: 2.3 ± 10.7 vs -0.6 ± 13.5, p = 0.083) and insufficient sleep (stays up more than one hour later the day before a holiday and wakes up more than one hour later on a holiday) (placebo vs LF: 0.1 ± 9.8 vs -1.7 ± 8.8, p = 0.095). No adverse drug reactions were found.
Conclusion


LF intake may improve sleep condition, especially morning symptoms in children above one year of age.",2020,"The change in total JSQ-P T scores tended to improve in the LF group (placebo vs LF: 0.5 ± 6.5 vs -1.9 ± 6.1, p = 0.074), in particular, morning symptoms significantly improved (grumpy in the morning, hard to wake-up, and hard to get out of bed)","['children above one year of age', 'Healthy children between the ages of 12 and 32 months who attended nursery schools in Japan', 'Eight participants were eliminated due to lost to follow-up, withdrawal of consent, and ineligibility, with 101 participants (placebo, n = 48; LF, n = 53) included in the full analysis set (FAS) and used for analysis', 'Children Aged 12-32 Months', '109 participants were randomized', 'children']","['placebo', 'lactoferrin (LF)-fortified formula', 'Lactoferrin', 'placebo or LF', 'Placebo']","['adverse drug reactions', 'insufficient sleep (stays', 'sleep condition', 'Wake-up time, bedtime, and nighttime sleep', 'Sleep Conditions', 'total JSQ-P T scores', ""Children's sleep conditions""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0578819', 'cui_str': 'Attending nursery school'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}]","[{'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",109.0,0.585726,"The change in total JSQ-P T scores tended to improve in the LF group (placebo vs LF: 0.5 ± 6.5 vs -1.9 ± 6.1, p = 0.074), in particular, morning symptoms significantly improved (grumpy in the morning, hard to wake-up, and hard to get out of bed)","[{'ForeName': 'Momoko', 'Initials': 'M', 'LastName': 'Miyakawa', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry Co., Ltd, Zama, Kanagawa, Japan.'}, {'ForeName': 'Shutaro', 'Initials': 'S', 'LastName': 'Kubo', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry Co., Ltd, Zama, Kanagawa, Japan.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Oda', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry Co., Ltd, Zama, Kanagawa, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Motoki', 'Affiliation': 'Department of Preventive Medicine and Public Health, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mizuki', 'Affiliation': 'Department of Preventive Medicine and Public Health, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Teruomi', 'Initials': 'T', 'LastName': 'Tsukahara', 'Affiliation': 'Department of Preventive Medicine and Public Health, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry Co., Ltd, Zama, Kanagawa, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Yamauchi', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry Co., Ltd, Zama, Kanagawa, Japan.'}, {'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Abe', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry Co., Ltd, Zama, Kanagawa, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Nomiyama', 'Affiliation': 'Department of Preventive Medicine and Public Health, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}]",Nature and science of sleep,['10.2147/NSS.S263106']
2665,33061725,Deciphering Age Differences in Experience-Based Decision-Making: The Role of Sleep.,"Objective


Recent studies have demonstrated that sleep not only facilitates memory consolidation but also benefits more complex cognitive skills such as decision-making in young adults. Older adults use different decision strategies compared with young adults, which leaves the role of sleep in older adults' decision-making unclear. We investigated the age-by-sleep effect on decision-making.
Methods


We recruited 67 young adults (ages 18 to 29 years) and 66 older adults (ages 60 to 79 years) and randomly assigned them into the ""sleep"" or ""wake"" study condition. They were given a modified Iowa gambling task to perform before and after a 12-hour interval with sleep or wakefulness.
Results


Using the typical model-free analysis, we found that young adults' between-session performance improved greater than that of older adults regardless of the sleep/wake condition. Furthermore, older adults with longer total sleep time showed a greater improvement in the selection of one ""good"" deck. To further examine the sleep effect on age-related differences in cognitive processes underlying decision-making, we conducted computational modelling. This more fine-grained analysis revealed that sleep improved feedback sensitivity for both young and older adults while it increased loss aversion for older adults but not for young adults.
Conclusion


These findings indicate that sleep promotes learning-based decision-making performance via facilitating value representation, and such modulation is distinct in young compared to older adults.",2020,"Furthermore, older adults with longer total sleep time showed a greater improvement in the selection of one ""good"" deck.","['Older adults', '67 young adults (ages 18 to 29 years) and 66 older adults (ages 60 to 79 years', 'young adults', 'older adults with longer']","['sleep"" or ""wake"" study condition']","['loss aversion', 'feedback sensitivity', 'total sleep time']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205166', 'cui_str': 'Long'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0233496', 'cui_str': 'Aversion'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",67.0,0.0221485,"Furthermore, older adults with longer total sleep time showed a greater improvement in the selection of one ""good"" deck.","[{'ForeName': 'Xue-Rui', 'Initials': 'XR', 'LastName': 'Peng', 'Affiliation': ""Faculty of Psychology, Southwest University, Chongqing, People's Republic of China.""}, {'ForeName': 'Yun-Rui', 'Initials': 'YR', 'LastName': 'Liu', 'Affiliation': ""Faculty of Psychology, Southwest University, Chongqing, People's Republic of China.""}, {'ForeName': 'Dong-Qiong', 'Initials': 'DQ', 'LastName': 'Fan', 'Affiliation': ""Faculty of Psychology, Southwest University, Chongqing, People's Republic of China.""}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': ""Faculty of Psychology, Southwest University, Chongqing, People's Republic of China.""}, {'ForeName': 'Quan-Ying', 'Initials': 'QY', 'LastName': 'Liu', 'Affiliation': ""Department of Biomedical Engineering, Southern University of Science and Technology, Shenzhen, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ""Faculty of Psychology, Southwest University, Chongqing, People's Republic of China.""}]",Nature and science of sleep,['10.2147/NSS.S272176']
2666,33061926,Interpersonal Psychotherapy as a Single Treatment for Borderline Personality Disorder: A Pilot Randomized-Controlled Study.,"Recent guidelines share the recommendations that psychotherapy plays a central role in the treatment of borderline personality disorder (BPD). In recent years, interpersonal psychotherapy adapted for treating BPD (IPT-BPD) was added to specific psychotherapies and was tested in combination with pharmacotherapy. The present study is aimed to assess the efficacy of IPT-BPD revised (IPT-BPD-R) as single treatment in a sample of BPD patients. Results obtained in a group of patients receiving IPT-BPD-R were compared with those observed in a control group in waiting list plus clinical management (WL/CM). Forty-three BPD subjects were randomly allocated to one of the two arms. Patients were assessed at baseline and after 10 months with the following assessment instruments: Clinical Global Impression Scale, Severity item (CGI-S), Social Occupational Functioning Assessment Scale (SOFAS), Borderline Personality Disorder Severity Index (BPDSI), Barratt Impulsiveness Scale, version 11 (BIS-11), Modified Overt Aggression Scale (MOAS), and Self Harm Inventory (SHI). Statistical analysis was performed with one-way analysis of variance (ANOVA) or chi-square test to compare baseline characteristics of the two treatment groups. Comparison of score changes at the end of the trial between the two groups was calculated for each rating scale with the analysis of variance for repeated measures. Seven patients (16.3%) discontinued the treatment in the first month of the trial for non-adherence. We found a significant effect within subjects (trial duration) for all rating scales, except for the MOAS. A significant effect between subjects (treatment modality) was found for CGI-S; SOFAS; BIS-11 total score and subscale ""non-planning impulsivity""; BPDSI total score and items ""interpersonal relationships,"" ""impulsivity,"" and ""identity."" So, results showed differences between groups in favor of psychotherapy in terms of reduction of severity of general psychopathology, improvement of social and occupational functioning, and decrease of global BPD symptoms and three specific domains. On the other hand, we did not find any differences between groups for self-harm behaviors and aggressive behaviors.",2020,"A significant effect between subjects (treatment modality) was found for CGI-S; SOFAS; BIS-11 total score and subscale ""non-planning impulsivity""; BPDSI total score and items ""interpersonal relationships,"" ""impulsivity,"" and ""identity.""","['a sample of BPD patients', 'Forty-three BPD subjects', 'Borderline Personality Disorder']","['IPT-BPD revised (IPT-BPD-R', 'Interpersonal Psychotherapy']","['CGI-S; SOFAS; BIS-11 total score and subscale ""non-planning impulsivity""; BPDSI total score and items ""interpersonal relationships,"" ""impulsivity,"" and ""identity', 'Clinical Global Impression Scale, Severity item (CGI-S), Social Occupational Functioning Assessment Scale (SOFAS), Borderline Personality Disorder Severity Index (BPDSI), Barratt Impulsiveness Scale, version 11 (BIS-11), Modified Overt Aggression Scale (MOAS), and Self Harm Inventory (SHI', 'severity of general psychopathology, improvement of social and occupational functioning', 'global BPD symptoms']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450368', 'cui_str': '43'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}]","[{'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",43.0,0.0263036,"A significant effect between subjects (treatment modality) was found for CGI-S; SOFAS; BIS-11 total score and subscale ""non-planning impulsivity""; BPDSI total score and items ""interpersonal relationships,"" ""impulsivity,"" and ""identity.""","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Bozzatello', 'Affiliation': 'Department of Neuroscience, University of Turin, Turin, Italy.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Bellino', 'Affiliation': 'Department of Neuroscience, University of Turin, Turin, Italy.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.578910']
2667,33061961,"Novel Pathologic Factors for Risk Stratification of Gastric ""Indefinite for Dysplasia"" Lesions.","Methods


In total, 123 IND cases with final diagnoses of cancer (29.3%), high-grade dysplasia (6.5%), low-grade dysplasia (11.4%), and nonneoplasm (52.8%) were randomly divided into test set ( n  = 27) and validation set ( n  = 96). By the image analysis, size, pleomorphism, hyperchromasia, irregularity of nuclei, and ratios of structural atypia area (SAA) to total IND area were measured in the test set. Using the validation set, consensus meetings were held for the evaluation of pathologic factors that predict the final diagnosis.
Results


By image analysis, the only ratio of SAA to total IND area was associated with the final diagnosis ( p  < 0.001). In the consensus meeting for validation, the nuclear factors, except loss of nuclear polarity ( p  = 0.004-0.026), could not predict the final diagnosis. Conversely, most structural factors could predict the final diagnosis. In particular, SAA > 25% was the most powerful predictive factor. We proposed criteria of risk stratification by using SAA > 25%, loss of surface maturation (LOSM), and loss of nuclear polarity (LONP) (Malignancy rate; Category 0: SAA ≤ 25% without LOSM and LONP; 0%, Category 1: SAA ≤ 25% with any of LOSM or LONP; 15.2%-16.7%, Category 2: SAA > 25% without LOSM and LONP; 44.4%-50.0%, Category 3: SAA > 25% with any of LOSM or LONP 54.5%-55.6%).
Conclusions


Structural atypia was more helpful than nuclear atypia and SAA > 25% was the most powerful predictor for the diagnosis of INDs of the stomach. We propose shortening the follow-up period to six months for Category 1, endoscopic resection for Category 2 and 3, postresection follow-up periods of one year for Category 2, and six months for Category 3.",2020,"In the consensus meeting for validation, the nuclear factors, except loss of nuclear polarity ( p  = 0.004-0.026), could not predict the final diagnosis.","['In total, 123 IND cases with final diagnoses of cancer (29.3%), high-grade dysplasia (6.5%), low-grade dysplasia (11.4%), and nonneoplasm (52.8']",[],"['loss of surface maturation (LOSM), and loss of nuclear polarity (LONP', 'size, pleomorphism, hyperchromasia, irregularity of nuclei, and ratios of structural atypia area (SAA) to total IND area']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332144', 'cui_str': 'Final diagnosis (discharge)'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C4517533', 'cui_str': '11.4'}]",[],"[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0032219', 'cui_str': 'Pleomorphism'}, {'cui': 'C0333910', 'cui_str': 'Hyperchromatism'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}]",123.0,0.0310418,"In the consensus meeting for validation, the nuclear factors, except loss of nuclear polarity ( p  = 0.004-0.026), could not predict the final diagnosis.","[{'ForeName': 'Kwangil', 'Initials': 'K', 'LastName': 'Yim', 'Affiliation': ""Department of Hospital Pathology, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jung Ha', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': ""Department of Hospital Pathology, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jinyoung', 'Initials': 'J', 'LastName': 'Yoo', 'Affiliation': ""Department of Hospital Pathology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}]",Gastroenterology research and practice,['10.1155/2020/9460681']
2668,33062008,Efficacy of Electroacupuncture Combined with Auricular Point Pressing in Improving Mental Well-Being among Individuals with Heroin Use Disorder: A Randomized Controlled Crossover Trial and Pilot Study.,"Objective


To evaluate the clinical efficacy of combining electroacupuncture with auricular point pressing in improving quality of life of individuals with heroin use disorder undergoing methadone maintenance treatment.
Design


A randomized controlled crossover trial.
Subjects


50 participants were recruited from Taipei City Hospital, Linsen Chinese Medicine and Kunming branches, and randomly allocated to treatment groups.
Method


The 36-Item Short Form Health Survey (SF-36) was used. Group A received electroacupuncture at the  Hegu  (LI4) and  Zusanli  (ST36) and auricular point pressing on Ear  Shenmen , and Group B received only auricular point pressing on Ear  Shenmen  biweekly for 4 weeks. After a 1-week washout period, crossover of the groups was performed.
Results


The SF-36 mental component scores of the combined treatment group improved relative to the single treatment group (11.09 vs. 10.33,  p =0.023). Methadone dosage was reduced in both groups (combined therapy group: 8.58 ± 4.17/7.76 ± 4.11 (baseline/posttreatment) vs. single therapy group: 8.36 ± 4.20/8.30 ± .28,  p =0.001).
Conclusion


Combined therapy of high-frequency electroacupuncture with auricular point pressing had better efficacy in enhancing quality of life, especially for mental well-being, and in gradually reducing methadone dosage.",2020,"The SF-36 mental component scores of the combined treatment group improved relative to the single treatment group (11.09 vs. 10.33,  p =0.023).","['Individuals with Heroin Use Disorder', 'individuals with heroin use disorder undergoing methadone maintenance treatment', 'Subjects\n\n\n50 participants were recruited from Taipei City Hospital, Linsen Chinese Medicine and Kunming branches']","['Methadone', 'electroacupuncture at the  Hegu  (LI4) and  Zusanli  (ST36) and auricular point pressing on Ear  Shenmen , and Group B received only auricular point pressing on Ear  Shenmen  biweekly for 4 weeks', 'electroacupuncture with auricular point pressing', 'Electroacupuncture Combined with Auricular Point']","['SF-36 mental component scores', 'quality of life', 'enhancing quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011892', 'cui_str': 'Heroin'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0445517', 'cui_str': 'Kunming'}, {'cui': 'C0205384', 'cui_str': 'Branching'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",50.0,0.0695117,"The SF-36 mental component scores of the combined treatment group improved relative to the single treatment group (11.09 vs. 10.33,  p =0.023).","[{'ForeName': 'Kai-Chiang', 'Initials': 'KC', 'LastName': 'Yu', 'Affiliation': 'Department of Chinese Medicine, Taipei City Hospital, Linsen Chinese Medicine and Kunming Branch, Taipei, Taiwan.'}, {'ForeName': 'Han-Ting', 'Initials': 'HT', 'LastName': 'Wei', 'Affiliation': 'Department of Psychiatry, Taipei City Hospital, Linsen Chinese Medicine and Kunming Branch, Taipei, Taiwan.'}, {'ForeName': 'Shang-Chih', 'Initials': 'SC', 'LastName': 'Chang', 'Affiliation': 'Department of Chinese Medicine, Taipei City Hospital, Linsen Chinese Medicine and Kunming Branch, Taipei, Taiwan.'}, {'ForeName': 'Chung-Hua', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'Department of Chinese Medicine, Taipei City Hospital, Linsen Chinese Medicine and Kunming Branch, Taipei, Taiwan.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/3748056']
2669,33062044,A randomized controlled trial to assess the effectiveness and safety of acupuncture for overactive bladder: a study in Hong Kong population.,"Background


Around 15% of the Hong Kong population was found to suffer from overactive bladder (OAB), but the current available treatments, such as medication, behavioral therapy and physical therapy are unsatisfactory. Previous studies have suggested that acupuncture may have promising effect for OAB, but some limitations on the study design render the evidence questionable. This study aimed to evaluate the effectiveness and safety of acupuncture treatment for patients with OAB in Hong Kong.
Methods


One hundred patients with OAB were enrolled. The patients were randomized to receive either active acupuncture or sham needle intervention twice a week for 8 consecutive weeks, and had a follow-up consultation 12 weeks after the completion of acupuncture intervention. The primary outcome assessment was the 3-Day Voiding Diary, which records daytime and night-time urinary frequency and symptoms, at the baseline, the end of the 8-week intervention and 12 weeks after acupuncture intervention. Secondary outcomes included Urine NGF level, Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6), as well as Overactive Bladder Symptom Score (OABSS).
Results


After 16 sessions of treatment, when compared with the baseline, both active and sham acupuncture significantly reduced the frequency of urgency urinary incontinence (UUI), daytime and night-time urinary frequency as well as the scores of IIQ-7, UDI-6 and OABSS. Moreover, the treatment effects could last for at least 3 months. However, no significant difference in frequency of UUI and daytime urinary frequency was found between the active and sham acupuncture groups. On the other hand, the night-time urinary frequency decreased more significantly during the treatment and follow-up in the active acupuncture group than in the sham control group after controlling baseline night-time urinary frequency. Urine NGF level could not be detected by ELISA method in our experiments.
Conclusion


This study suggests a beneficial effect of acupuncture on improving OAB symptoms. Both active and sham acupuncture treatment were able to improve the symptoms of frequency of urgency urinary incontinence, and the daytime and night-time urinary frequency, while only mild adverse effects were found. This project was unable to establish the specific effect of acupuncture for OAB. Trial registration  Chinese Clinical Trial Registry, ChiCTR-INR-16010048. Registered on 29 Nov 2016.",2020,"However, no significant difference in frequency of UUI and daytime urinary frequency was found between the active and sham acupuncture groups.","['patients with OAB in Hong Kong', 'One hundred patients with OAB were enrolled', 'Hong Kong population']","['active acupuncture or sham needle intervention', 'acupuncture', 'acupuncture intervention']","['3-Day Voiding Diary, which records daytime and night-time urinary frequency and symptoms', 'night-time urinary frequency', 'symptoms of frequency of urgency urinary incontinence, and the daytime and night-time urinary frequency', 'effectiveness and safety', 'frequency of urgency urinary incontinence (UUI), daytime and night-time urinary frequency as well as the scores of IIQ-7, UDI-6 and OABSS', 'Urine NGF level', 'OAB symptoms', 'frequency of UUI and daytime urinary frequency', 'Urine NGF level, Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6), as well as Overactive Bladder Symptom Score (OABSS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",100.0,0.0900942,"However, no significant difference in frequency of UUI and daytime urinary frequency was found between the active and sham acupuncture groups.","[{'ForeName': 'Zhi-Xiu', 'Initials': 'ZX', 'LastName': 'Lin', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR China.'}, {'ForeName': 'Ngai Ho Tony', 'Initials': 'NHT', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine & Geriatrics, Pok Oi Hospital, Yuen Long, N.T., Hong Kong SAR China.'}, {'ForeName': 'Yiu-Keung', 'Initials': 'YK', 'LastName': 'Kwan', 'Affiliation': 'Department of Medicine & Geriatrics, Tuen Mun Hospital, Tuen Mun, N.T., Hong Kong SAR China.'}, {'ForeName': 'Yu Tat', 'Initials': 'YT', 'LastName': 'Chan', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR China.'}, {'ForeName': 'Kam-Yuk Sylvia', 'Initials': 'KS', 'LastName': 'Tam', 'Affiliation': 'Yan Oi Tong - The Chinese University of Hong Kong Chinese Medicine Centre for Training & Research, Tuen Mun, N.T., Hong Kong, SAR China.'}, {'ForeName': 'Mei Kwan', 'Initials': 'MK', 'LastName': 'Lai', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR China.'}, {'ForeName': 'Chun-Kam', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR China.'}, {'ForeName': 'Kit', 'Initials': 'K', 'LastName': 'Ngan', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR China.'}, {'ForeName': 'Stella Yin Yuen', 'Initials': 'SYY', 'LastName': 'Tsoi', 'Affiliation': 'Yan Oi Tong - The Chinese University of Hong Kong Chinese Medicine Centre for Training & Research, Tuen Mun, N.T., Hong Kong, SAR China.'}, {'ForeName': 'Yiu Wa', 'Initials': 'YW', 'LastName': 'Lau', 'Affiliation': 'Yan Oi Tong - The Chinese University of Hong Kong Chinese Medicine Centre for Training & Research, Tuen Mun, N.T., Hong Kong, SAR China.'}, {'ForeName': 'Yan-Fang', 'Initials': 'YF', 'LastName': 'Xian', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR China.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ching', 'Affiliation': 'Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR China.'}, {'ForeName': 'Yuanqi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Pok Oi Hospital - The Chinese University of Hong Kong Chinese Medicine Centre for Training & Research, Shatin, N.T., Hong Kong SAR China.'}]",Chinese medicine,['10.1186/s13020-020-00388-w']
2670,33055336,MODERN METHODS OF PREVENTION AND TREATMENT OF COMPLICATIONS OF CERVICAL ESOPHAGO-ORGAN ANASTOMOSIS AT ESOPHAGOPLASTY.,"OBJECTIVE


The aim: To improve the results of operative treatment of esophageal strictures by decreasing the rate of failure and stricture of cervical esophago-organ anastomoses.
PATIENTS AND METHODS


Materials and methods: There were 45 patients with post-burn corrosive gullet strictures, 17 patients with postoperative corrosive strictures, 10 patients with peptic strictures secondary to reflux-esophagitis, 42 patients with esophageal cancer strictures. The patients were divided into two groups: the comparison group - 55 persons and the main group - 59 persons. Patients of comparison group underwent surgical treatment of esophageal strictures according to classic protocols and standards. In the main group of patients we applied proposed diagnostic algorithm with prediction of complication risk and the designed method of esophago-organ anastomosis formation.
RESULTS


Results: The results of operative treatment in patients with esophageal strictures showed the development of early postoperative complications in 59 individuals (51.75 %). In the postoperative period six patients died: four - in the comparison group and two - in the main group. Failure of cervical esophago-organ anastomosis and esophageal strictures occurred in 7 patients (11.86 %) of main group and 20 patients (36.36 %) of the comparison group (p<0.05).
CONCLUSION


Conclusions: Application of method predicting the risk of complications of cervical anastomosis, treatment program and instrumental method of formation anastomosis resulted in reduced incidence of failure and strictures of esophago-organ anastomosis from 36.36 % to 11.86 % (p<0.05); decreased time of hospitalization - from 28.2 ± 1.1 to 21.5 ± 0.5 bed-days (p<0.001), postoperative period - from 20.5 ± 1.1 to 16.1 ± 0.7 bed-days (p<0.01); decreased postoperative mortality - from 7.27 % to 3.39 %.",2020,"Failure of cervical esophago-organ anastomosis and esophageal strictures occurred in 7 patients (11.86 %) of main group and 20 patients (36.36 %) of the comparison group (p<0.05).
","['45 patients with post-burn corrosive gullet strictures, 17 patients with postoperative corrosive strictures, 10 patients with peptic strictures secondary to reflux-esophagitis, 42 patients with esophageal cancer strictures', 'patients with esophageal strictures']",['surgical treatment of esophageal strictures'],"['postoperative mortality', 'incidence of failure and strictures of esophago-organ anastomosis', 'Failure of cervical esophago-organ anastomosis and esophageal strictures', 'development of early postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0524525', 'cui_str': 'Corrosives'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0443277', 'cui_str': 'Peptic'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0014869', 'cui_str': 'Esophagitis, Reflux'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C4551650', 'cui_str': 'Stricture of esophagus'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C4551650', 'cui_str': 'Stricture of esophagus'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C4551650', 'cui_str': 'Stricture of esophagus'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",42.0,0.022756,"Failure of cervical esophago-organ anastomosis and esophageal strictures occurred in 7 patients (11.86 %) of main group and 20 patients (36.36 %) of the comparison group (p<0.05).
","[{'ForeName': 'Volodymyr O', 'Initials': 'VO', 'LastName': 'Shaprynskyi', 'Affiliation': 'NATIONAL PIROGOV MEMORIAL MEDICAL UNIVERSITY, VINNYTSIA, UKRAINE.'}, {'ForeName': 'Yevhen V', 'Initials': 'YV', 'LastName': 'Shaprynskyi', 'Affiliation': 'NATIONAL PIROGOV MEMORIAL MEDICAL UNIVERSITY, VINNYTSIA, UKRAINE.'}, {'ForeName': 'Mustafa Bassam', 'Initials': 'MB', 'LastName': 'Hussein', 'Affiliation': 'NATIONAL PIROGOV MEMORIAL MEDICAL UNIVERSITY, VINNYTSIA, UKRAINE.'}, {'ForeName': 'Oleg O', 'Initials': 'OO', 'LastName': 'Vorovskyi', 'Affiliation': 'NATIONAL PIROGOV MEMORIAL MEDICAL UNIVERSITY, VINNYTSIA, UKRAINE.'}, {'ForeName': 'Yaroslav V', 'Initials': 'YV', 'LastName': 'Karyi', 'Affiliation': 'NATIONAL PIROGOV MEMORIAL MEDICAL UNIVERSITY, VINNYTSIA, UKRAINE.'}, {'ForeName': 'Liudmyla A', 'Initials': 'LA', 'LastName': 'Shaprynska', 'Affiliation': 'NATIONAL PIROGOV MEMORIAL MEDICAL UNIVERSITY, VINNYTSIA, UKRAINE.'}, {'ForeName': 'Serhii P', 'Initials': 'SP', 'LastName': 'Dmytryshyn', 'Affiliation': 'NATIONAL PIROGOV MEMORIAL MEDICAL UNIVERSITY, VINNYTSIA, UKRAINE.'}]","Wiadomosci lekarskie (Warsaw, Poland : 1960)",[]
2671,33055441,"Safety and Efficacy of Oral Intake of Ceramide-Containing Acetic Acid Bacteria for Improving the Stratum Corneum Hydration: A Randomized, Double-Blind, Placebo-Controlled Study over 12 Weeks.","The barrier function of the skin protects it from external stresses to which it is constantly exposed, such as dryness, ultraviolet rays, and chemicals. Lipids, in particular a type of sphingolipid known as ceramides, play a central role in the barrier function of the skin by preventing dryness. The number of ceramides in the skin is known to decrease with age, which has led to the development of a large number of anti-aging cosmetic products that contain ceramides. Recently, it has become evident that oral intake of ceramides can also improve the quality of the skin. To elucidate the effects of oral ceramide intake on skin moisture content, we conducted a randomized, double-blinded, placebo-controlled parallel comparative study in which males and females between 20 and 60 years of age who were worried about dry skin ingested a food with acetic acid bacteria containing 0.8 mg of dihydroceramide or a placebo for 12 weeks. Concurrently, we investigated the safety of continuous ingestion of the ceramide-containing food over 12 weeks. Oral intake of ceramide over the 12 weeks significantly improved stratum corneum hydration, i.e. the moisture content of the skin, and did not result in harmful effects in any of the participants.",2020,"Oral intake of ceramide over the 12 weeks significantly improved stratum corneum hydration, i.e. the moisture content of the skin, and did not result in harmful effects in any of the participants.","['for 12 weeks', 'males and females between 20 and 60 years of age who were worried about dry skin ingested a food with']","['Ceramide-Containing Acetic Acid Bacteria', 'oral ceramide intake', 'placebo', 'acetic acid bacteria containing 0.8 mg of dihydroceramide or a placebo', 'Placebo']","['Stratum Corneum Hydration', 'stratum corneum hydration']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0668446', 'cui_str': 'dihydroceramide'}]","[{'cui': 'C0221921', 'cui_str': 'Stratum corneum structure'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}]",,0.166454,"Oral intake of ceramide over the 12 weeks significantly improved stratum corneum hydration, i.e. the moisture content of the skin, and did not result in harmful effects in any of the participants.","[{'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Tsuchiya', 'Affiliation': 'Central Research Institute, Mizkan Holdings Co., Ltd.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Ban', 'Affiliation': 'Central Research Institute, Mizkan Holdings Co., Ltd.'}, {'ForeName': 'Mikiya', 'Initials': 'M', 'LastName': 'Kishi', 'Affiliation': 'Central Research Institute, Mizkan Holdings Co., Ltd.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Ono', 'Affiliation': 'Ueno-Asagao Clinic.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Masaki', 'Affiliation': 'School of Bioscience and Biotechnology, Tokyo University of Technology.'}]",Journal of oleo science,['10.5650/jos.ess20115']
2672,33055462,Safety and Efficacy of Simultaneous Inoculations of Pneumococcal and Influenza Vaccines in Patients with Coronary Artery Disease.,"AIM


Pneumococcal and influenza infections can cause serious morbidity and mortality in patients with cardiovascular diseases. The purpose of this study was to investigate the safety and efficacy of simultaneous inoculations of 23-valent pneumococcal polysaccharide vaccine (PPSV23) and trivalent influenza vaccine (TIV) in patients with coronary artery disease (CAD).
METHODS


This was a prospective, randomized, single-blind, placebo-controlled study. A total of 40 patients with CAD were randomly assigned to the TIV＋PPSV23 (simultaneous inoculations of TIV and PPSV23) and TIV＋Placebo (inoculations of TIV and placebo) groups. Primary outcomes were the safety of simultaneous vaccinations and the changing of circulating cardiovascular biomarkers before, at 4-, and at 12-weeks after vaccinations.
RESULTS


The baseline characteristics between the two groups were identical. The prevalence of injection-site pain, swelling, and reddening were 47%, 37%, and 37% in the TIV＋PPSV23 group, and 10%, 5%, and 0% in the TIV＋Placebo group, respectively. All reactions were self-limited. Body temperature ＞37.0℃ or serious injection-related reaction was not observed. The levels of white blood cells, high-sensitivity C-reactive protein, N-terminal pro-B-type natriuretic peptide, pentraxin-3, and malondialdehide-modified low-density lipoprotein (LDL), were not significantly different between the two groups before and after vaccinations. The levels of anti-oxidized LDL were significantly and step-wisely decreased from baseline, to 4-, and 12-weeks vaccinations in the both groups. No significant changes of other markers were observed in both groups at each time point.
CONCLUSION


Simultaneous inoculations of TIV and PPSV23 were safety in patients with CAD, suggesting that dual vaccinations can be considered even in patients with CAD.",2020,"The levels of anti-oxidized LDL were significantly and step-wisely decreased from baseline, to 4-, and 12-weeks vaccinations in the both groups.","['patients with coronary artery disease (CAD', '40 patients with CAD', 'patients with cardiovascular diseases', 'patients with CAD', 'Patients with Coronary Artery Disease']","['23-valent pneumococcal polysaccharide vaccine (PPSV23) and trivalent influenza vaccine (TIV', 'placebo', 'Simultaneous Inoculations of Pneumococcal and Influenza Vaccines', 'TIV＋Placebo', 'TIV＋PPSV23 (simultaneous inoculations of TIV and PPSV23) and TIV＋Placebo (inoculations of TIV and placebo', 'TIV＋PPSV23']","['Body temperature', 'safety of simultaneous vaccinations and the changing of circulating cardiovascular biomarkers', 'levels of white blood cells, high-sensitivity C-reactive protein, N-terminal pro-B-type natriuretic peptide, pentraxin-3, and malondialdehide-modified low-density lipoprotein (LDL', 'Safety and Efficacy', 'levels of anti-oxidized LDL', 'safety and efficacy', 'prevalence of injection-site pain, swelling, and reddening']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0961101', 'cui_str': '23-valent pneumococcal capsular polysaccharide vaccine'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0947642', 'cui_str': 'Pneumovax 23'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0174234', 'cui_str': 'PTX3 protein'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}]",40.0,0.123126,"The levels of anti-oxidized LDL were significantly and step-wisely decreased from baseline, to 4-, and 12-weeks vaccinations in the both groups.","[{'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Shimada', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Morinaga', 'Affiliation': 'Division of Cardiovascular Medicine, Tokyo Metropolitan Tama Medical Center.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kiyanagi', 'Affiliation': 'Division of General Medicine, Obihiro Daiichi Hospital.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Nishitani-Yokoyama', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine.'}, {'ForeName': 'Iwao', 'Initials': 'I', 'LastName': 'Okai', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tamura', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine.'}, {'ForeName': 'Hakuoh', 'Initials': 'H', 'LastName': 'Konishi', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kurata', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Miyauchi', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Daida', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine.'}]",Journal of atherosclerosis and thrombosis,['10.5551/jat.58297']
2673,33055515,Randomized Controlled Trial of a Spectacle Lens for Macular Degeneration.,"SIGNIFICANCE


E-Scoop, a spectacle lens, provides no clinically relevant improvements on quality of life, visual acuity, and contrast sensitivity for patients with AMD. Because patients' burden is high and therapeutic options are scarce, the incentive to develop effective vision rehabilitation interventions remains.
PURPOSE


Patients with AMD experience low quality of life due to vision loss, despite angiogenesis inhibitor interventions that slow down progression for some patients. E-Scoop, which includes low-power prisms, 6% magnification, yellow tint, and antireflection coating, might aid in daily activities by improving distance viewing. Separately, these features have little proven effectiveness. E-Scoop has not been formally tested. This study aimed to determine the impact of E-Scoop on quality of life and the effect on visual acuity and contrast sensitivity.
METHODS


In this randomized controlled, open-label trial, 190 of 226 eligible patients were included. The primary outcome was quality of life measured with the 25-item National Eye Institute Visual Function Questionnaire. Secondary outcomes were visual acuity and contrast sensitivity. The follow-up for quality of life was after 6 weeks for controls and after 3 weeks of use for E-Scoop wearers. The visual measures were repeated after 6 weeks, with optimal refractive correction, with and without E-Scoop.
RESULTS


Randomization resulted in 99 E-Scoop and 86 control group patients for intention-to-treat analysis. No differential change was found between the E-Scoop and control groups on the 25-item National Eye Institute Visual Function Questionnaire using Rasch analysis (Cohen d = -0.07, P = .53). Statistically significant but small effects were found in favor of E-Scoop on binocular visual acuity (mean difference, 0.05 logMAR [2.5 letters, P < .001]) and contrast sensitivity (mean difference, 0.10 logCS [2 letters, P < .001]).
CONCLUSIONS


No effect of E-Scoop on quality of life was found. E-Scoop showed effects that were statistically significant, although not clinically meaningful and within typical variability, on visual measures.",2020,"No differential change was found between the E-Scoop and control groups on the 25-item National Eye Institute Visual Function Questionnaire using Rasch analysis (Cohen d = -0.07, P = .53).","['patients with AMD', '190 of 226 eligible patients were included', 'Macular Degeneration']","['E-Scoop', 'Spectacle Lens']","['quality of life, visual acuity, and contrast sensitivity', '25-item National Eye Institute Visual Function Questionnaire', 'binocular visual acuity', 'contrast sensitivity', 'visual acuity and contrast sensitivity', 'quality of life', 'quality of life measured with the 25-item National Eye Institute Visual Function Questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0024437', 'cui_str': 'Degenerative disorder of macula'}]","[{'cui': 'C0183177', 'cui_str': 'Scoop'}, {'cui': 'C0181607', 'cui_str': 'Spectacle lens'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",226.0,0.230606,"No differential change was found between the E-Scoop and control groups on the 25-item National Eye Institute Visual Function Questionnaire using Rasch analysis (Cohen d = -0.07, P = .53).","[{'ForeName': 'Martijn S', 'Initials': 'MS', 'LastName': 'Visser', 'Affiliation': 'Section of Medical Psychology and Psychotherapy, Department of Psychiatry, Erasmus Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Reinier', 'Initials': 'R', 'LastName': 'Timman', 'Affiliation': 'Section of Medical Psychology and Psychotherapy, Department of Psychiatry, Erasmus Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Joanneke', 'Initials': 'J', 'LastName': 'Kampen-Smalbrugge', 'Affiliation': 'Rotterdam Ophthalmic Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Buis', 'Affiliation': 'Revoir Group, the Hague, the Netherlands.'}, {'ForeName': 'Jan Roelof', 'Initials': 'JR', 'LastName': 'Polling', 'Affiliation': 'Department of Ophthalmology, Erasmus Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'J J V', 'Initials': 'JJV', 'LastName': 'Busschbach', 'Affiliation': 'Section of Medical Psychology and Psychotherapy, Department of Psychiatry, Erasmus Medical Center, Rotterdam, the Netherlands.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001588']
2674,33055588,Phase II Adjuvant Cancer-specific Vaccine Therapy for Esophageal Cancer Patients Curatively Resected After Preoperative Therapy With Pathologically Positive Nodes; Possible Significance of Tumor Immune Microenvironment in its Clinical Effects.,"OBJECTIVES


To elucidate the efficacy of adjuvant vaccine monotherapy using 3 Human Leukocyte Antigen (HLA)-A24-restricted tumor-specific peptide antigens for ESCC, upregulated lung cancer 10, cell division cycle associated 1, and KH domain-containing protein overexpressed in cancer 1.
SUMMARY OF BACKGROUND DATA


ESCC patients with pathologically positive nodes (pN(+)) have a high risk for postoperative recurrence, despite curative resection after preoperative therapy. Subclinical micrometastases are an appropriate target for cancer vaccine.
METHODS


This is a non-randomized prospective phase II clinical trial (UMIN000003557). ESCC patients curatively resected after preoperative therapy with pN(+) were allocated into the control and vaccine groups (CG and VG) according to the HLA-A status. One mg each of three epitope peptides was postoperatively injected 10 times weekly followed by 10 times biweekly to the VG. The primary and secondary endpoints were relapse-free survival (RFS) and esophageal cancer-specific survival (ECSS), respectively.
RESULTS


Thirty were in the CG and 33 in the VG. No significant difference was observed in RFS between the CG and VG (5-year RFS: 32.5% vs 45.3%), but the recurrence rate significantly decreased with the number of peptides which induced antigen-specific cytotoxic T lymphocytes. The VG showed a significantly higher 5-year ECSS than the CG (60.0% vs 32.4%, P = 0.045) and this difference was more prominent in patients with CD8 and programmed death-ligand 1 double negative tumor (68.0% vs 17.7%, P = 0.010).
CONCLUSIONS


Our cancer peptide vaccine might improve the survival of ESCC patients, which is warranted to be verified in the phase III randomized controlled study.",2020,"The primary and secondary endpoints were relapse-free survival (RFS) and esophageal cancer-specific survival (ECSS), respectively.
","['Esophageal Cancer Patients', 'ESCC patients curatively resected after preoperative therapy with pN', 'ESCC patients with pathologically positive nodes (pN']","['Adjuvant Cancer-specific Vaccine Therapy', 'adjuvant vaccine monotherapy']","['relapse-free survival (RFS) and esophageal cancer-specific survival (ECSS), respectively', 'recurrence rate', '5-year ECSS', 'RFS']","[{'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0042209', 'cui_str': 'Therapy, Vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.0437746,"The primary and secondary endpoints were relapse-free survival (RFS) and esophageal cancer-specific survival (ECSS), respectively.
","[{'ForeName': 'Takushi', 'Initials': 'T', 'LastName': 'Yasuda', 'Affiliation': '*Department of Surgery, Kindai University Faculty of Medicine, Osaka, Japan †Department of Surgery, Ohita Nakamura Hospital, Ohita, Japan ‡Life Science Research Institute, Kindai University, Osaka, Japan §Clinical Research Center, Kindai University Hospital, Osaka, Japan ¶Division of Cell Biology, Biomedical Research Center, Juntendo University Graduate School of Medicine, Tokyo, Japan ||Division of Hospital Pathology, Kindai University Hospital, Osaka, Japan **Cancer Precision Medical Center, Tokyo, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Nishiki', 'Affiliation': ''}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Hiraki', 'Affiliation': ''}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kato', 'Affiliation': ''}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Iwama', 'Affiliation': ''}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Shiraishi', 'Affiliation': ''}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Yasuda', 'Affiliation': ''}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Shinkai', 'Affiliation': ''}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kimura', 'Affiliation': ''}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sukegawa', 'Affiliation': ''}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Chiba', 'Affiliation': ''}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Imano', 'Affiliation': ''}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Takeda', 'Affiliation': ''}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Satou', 'Affiliation': ''}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Shiozaki', 'Affiliation': ''}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000003880']
2675,33055589,Surgical Outcomes After Neoadjuvant Chemoradiation Followed by Curative Surgery in Patients With Esophageal Cancer: An Intergroup Phase lll Trial of the Swiss Group for Clinical Cancer Research (SAKK 75/08).,"OBJECTIVE


To assess the impact of surgical technique in regard to morbidity and mortality after neoadjuvant treatment for esophageal cancer.
BACKGROUND


The SAKK trial 75/08 was a multicenter phase III trial (NCT01107639) comparing induction chemotherapy followed by chemoradiation and surgery in patients with locally advanced esophageal cancer.
METHODS


Patients in the control arm received induction chemotherapy with cisplatin and docetaxel, followed by concomitant chemoradiation therapy with cisplatin, docetaxel, and 45Gy. In the experimental arm, the same regimen was used with addition of cetuximab. After completion of neoadjuvant treatment, patients underwent esophagectomy. The experimental arm received adjuvant cetuximab. Surgical outcomes and complications were prospectively recorded and analyzed.
RESULTS


Total of 259 patients underwent esophagectomy. Overall complication rate was 56% and reoperation rate was 15% with no difference in complication rates for transthoracic versus transhiatal resections (56% vs 54%, P = 0.77), nor for video assisted thoracic surgeries (VATS) versus open transthoracic resections (67% vs 55%, P = 0.32). There was a trend to higher overall complication rates in squamous cell carcinoma versus adenocarcinoma (65% vs 51%, P = 0.035), and a significant difference in ARDS in squamous cell carcinoma with 14% versus 2% in adenocarcinoma (P = 0.0002). For patients with involved lymph nodes, a lymph node ratio of ≥0.1 was an independent predictor of PFS (HR 2.5, P = 0.01) and OS (HR 2.2, P = 0.03).
CONCLUSIONS


This trial showed no difference in surgical complication rates between transthoracic and transhiatal resections. For patients with involved lymph nodes, lymph node ratio was an independent predictor of progression free survival and overall survival.",2020,"Overall complication rate was 56% and reoperation rate was 15% with no difference in complication rates for transthoracic versus transhiatal resections (56% vs 54%, P = 0.77), nor for video assisted thoracic surgeries (VATS) versus open transthoracic resections (67% vs 55%, P = 0.32).","['Patients in the control arm received', 'patients with locally advanced esophageal cancer', 'Patients With Esophageal Cancer', '259 patients underwent esophagectomy']","['induction chemotherapy followed by chemoradiation and surgery', 'Neoadjuvant Chemoradiation Followed by Curative Surgery', 'adjuvant cetuximab', 'esophagectomy', 'cetuximab', 'induction chemotherapy with cisplatin and docetaxel, followed by concomitant chemoradiation therapy with cisplatin, docetaxel, and 45Gy']","['reoperation rate', 'Overall complication rate', 'ARDS in squamous cell carcinoma', 'Surgical Outcomes', 'complication rates', 'surgical complication rates', 'progression free survival and overall survival', 'overall complication rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",259.0,0.137492,"Overall complication rate was 56% and reoperation rate was 15% with no difference in complication rates for transthoracic versus transhiatal resections (56% vs 54%, P = 0.77), nor for video assisted thoracic surgeries (VATS) versus open transthoracic resections (67% vs 55%, P = 0.32).","[{'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'von Holzen', 'Affiliation': '*University Hospital Basel, Basel, Switzerland Universitätsspital, Basel, Switzerland †Indiana University School of Medicine South Bend, Goshen Center for Cancer Care, Goshen, Indiana ‡Charité - University Medicine, Berlin, Germany now at Klinikum Ernst von Bergmann gemeinnützige GmbH, Potsdam, Germany §SAKK Coordinating Center, Bern, Switzerland ¶Cantonal hospital St. Gallen Kantonsspital St. Gallen, St. Gallen, Switzerland ||Cantonal Hospital Winterthur, Kantonsspital Winterthur, Winterthur, Switzerland **University Hospital Giessen and Marburg, Universitätsklinikum Giessen und Marburg GmbH, Giessen, Germany ††City Hospital Triemli Stadtspital Triemli, Zürich, Switzerland ‡‡University Hospital Düsseldorf, Dusseldorf Germany §§University Hospital Lille Centre Hospitalier Régional Universitaire de Lille, Lille Cedex, France ¶¶Cantonal hospital Olten, Olten, Switzerland Kantonsspital Olten, Switzerland, now at chirurgieaarau, Aarau, Switzerland ||||Lausanne University Hospital, Lausanne, Switzerland ***Elisabethinen Hospital Linz Krankenhaus der Elisabethinen Linz, Linz, Austria †††Eberhard Karls University Tübingen, Tübingen, Germany ‡‡‡University Hospital Bern Inselspital Bern, Bern, Switzerland §§§Cantonal Hospital Graubunden Kantonsspital Graubünden, Chur, Switzerland ¶¶¶Kliniken Essen-Mitte, Essen, Germany ||||||Cantonal Hospital St. Gallen, St. Gallen Kantonsspital St. Gallen, Switzerland, now at Brustzentrum Ostschweiz, St. Gallen, Switzerland.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hayoz', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Steffen', 'Affiliation': ''}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Grieder', 'Affiliation': ''}, {'ForeName': 'Detlef', 'Initials': 'D', 'LastName': 'Bartsch', 'Affiliation': ''}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Schnider', 'Affiliation': ''}, {'ForeName': 'Wolfram-Trudo', 'Initials': 'WT', 'LastName': 'Knoefel', 'Affiliation': ''}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Piessen', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kettelhack', 'Affiliation': ''}, {'ForeName': 'Walter R', 'Initials': 'WR', 'LastName': 'Marti', 'Affiliation': ''}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Schäfer', 'Affiliation': ''}, {'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Függer', 'Affiliation': ''}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Königsrainer', 'Affiliation': ''}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Gloor', 'Affiliation': ''}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Furrer', 'Affiliation': ''}, {'ForeName': 'Marie-Aline', 'Initials': 'MA', 'LastName': 'Gérard', 'Affiliation': ''}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Hawle', 'Affiliation': ''}, {'ForeName': 'Martin K', 'Initials': 'MK', 'LastName': 'Walz', 'Affiliation': ''}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Alesina', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ruhstaller', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004334']
2676,33055594,"Response to the Comment on ""Intracorporeal or Extracorporeal Ileocolic Anastomosis After Laparoscopic Right Colectomy. A Double-blinded Randomized Controlled Trial"".",,2020,,[],"['Intracorporeal or Extracorporeal Ileocolic Anastomosis', 'Laparoscopic Right Colectomy']",[],[],"[{'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0192751', 'cui_str': 'Ileocolic anastomosis'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192861', 'cui_str': 'Right colectomy'}]",[],,0.665648,,"[{'ForeName': 'Marco E', 'Initials': 'ME', 'LastName': 'Allaix', 'Affiliation': 'Department of Surgical Sciences, University of Torino Torino, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Morino', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004164']
2677,33054113,Intravenous iron preparations transiently generate non-transferrin-bound iron from two proposed pathways.,"Intravenous iron-carbohydrate complex preparations (IVIPs) are non-interchangeable pro-drugs: their pharmacokinetics (PK) varies determined by semi-crystalline iron core and carbohydrate shell structures, influences pharmacodynamics (PD) and thus efficacy and safety. Examining PK/PD relationships of 3 IVIPs we identify a two-pathway model of transient NTBI generation following single dose administration. 28 hypoferremic non-anemic patients randomized to 200mg iron as ferric carboxymaltose (Fe-carboxymaltose), iron sucrose (Fe-sucrose), iron isomaltoside 1000 (Fe-isomaltoside-1000), n=8/arm, or placebo, n=4, on a 2-week PK/PD study, had samples analysed for total serum iron, IVIP-iron, transferrin-bound iron (TBI) by HPLC-ICP-MS, transferrin saturation (TSAT), serum ferritin (s-Ferritin) by standard methods, non-TBI (NTBI) and hepcidin as published before. IVIP-dependent increases in these parameters returned to baseline in 48-150h, except for s-Ferritin and TSAT. NTBI was low with Fe-isomaltoside-1000 (0.13µM at 8h), rapidly increased with Fe-sucrose (0.8µM at 2h, 1.25µM at 4h), and delayed for Fe-carboxymaltose (0.57µM at 24h). NTBI AUCs were 7-fold greater for Fe-carboxymaltose and Fe-sucrose than for Fe-isomaltoside-1000. Hepcidin peak time varied, but not AUC or mean levels. s-Ferritin levels and AUC were highest for Fe-carboxymaltose and greater than placebo for all IVIPs. We propose 2 mechanisms for the observed NTBI kinetics: rapid and delayed NTBI appearance consistent with direct (circulating IVIP-to-plasma) and indirect (IVIP-to-macrophage-to-plasma) iron release based on IVIP plasma half-life and s-Ferritin dynamics. IVIPs generate different, broadly stability- and PK-dependent, NTBI and s-Ferritin signatures, which may influence iron bioavailability, efficacy and safety. Longer-term studies should link NTBI exposure to subsequent safety and efficacy parameters and potential clinical consequences.",2020,s-Ferritin levels and AUC were highest for Fe-carboxymaltose and greater than placebo for all IVIPs.,['28 hypoferremic non-anemic patients'],"['placebo', '200mg iron as ferric carboxymaltose (Fe-carboxymaltose), iron sucrose (Fe-sucrose), iron isomaltoside 1000 (Fe-isomaltoside-1000), n=8/arm, or placebo', 'Intravenous iron-carbohydrate complex preparations (IVIPs']","['NTBI AUCs', 'Hepcidin peak time', 'iron bioavailability, efficacy and safety', 'total serum iron, IVIP-iron, transferrin-bound iron (TBI) by HPLC-ICP-MS, transferrin saturation (TSAT), serum ferritin (s-Ferritin) by standard methods, non-TBI (NTBI) and hepcidin', 's-Ferritin levels and AUC', 'NTBI']","[{'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C0060241', 'cui_str': 'iron sucrose'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C2947549', 'cui_str': 'iron isomaltoside 1000'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0301498', 'cui_str': 'Iron carbohydrate complex'}]","[{'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0040679', 'cui_str': 'Transferrin'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0008562', 'cui_str': 'High pressure liquid chromatography'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",28.0,0.05506,s-Ferritin levels and AUC were highest for Fe-carboxymaltose and greater than placebo for all IVIPs.,"[{'ForeName': 'Maciej W', 'Initials': 'MW', 'LastName': 'Garbowski', 'Affiliation': ""University College London (UCL) Cancer Institute Haematology Department; King's College London (KCL) Institute of Pharmaceutical Science; London Metallomics Consortium. maciej.garbowski@ucl.ac.uk.""}, {'ForeName': 'Sukhvinder', 'Initials': 'S', 'LastName': 'Bansal', 'Affiliation': ""King's College London (KCL) Institute of Pharmaceutical Science.""}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Porter', 'Affiliation': 'University College London (UCL) Cancer Institute Haematology Department.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Mori', 'Affiliation': 'Vifor Pharma Group, Glattbrugg.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Burckhardt', 'Affiliation': 'Vifor Pharma Group, Glattbrugg.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Hider', 'Affiliation': ""King's College London (KCL) Institute of Pharmaceutical Science; London Metallomics Consortium.""}]",Haematologica,['10.3324/haematol.2020.250803']
2678,32877578,Antisense Inhibition of Prekallikrein to Control Hereditary Angioedema.,"Hereditary angioedema is characterized by recurrent and unpredictable episodes of subcutaneous and mucosal swelling that can be life threatening. IONIS-PKK-L Rx  is a ligand-conjugated antisense oligonucleotide designed for receptor-mediated delivery to hepatocytes. In a compassionate-use pilot study, two patients with severe bradykinin-mediated angioedema were initially administered weekly subcutaneous injections of the unconjugated parent drug, IONIS-PKK Rx , for 12 to 16 weeks, after which they received IONIS-PKK-L Rx  at a dose of 80 mg every 3 to 4 weeks for 7 to 8 months. Treatment was accompanied by a reduction in the angioedema attack rate. (Funded by Amsterdam UMC.).",2020,Treatment was accompanied by a reduction in the angioedema attack rate.,['two patients with severe bradykinin-mediated angioedema'],[],['angioedema attack rate'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0006100', 'cui_str': 'Kallidin I'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002994', 'cui_str': 'Angioedema'}]",[],"[{'cui': 'C0002994', 'cui_str': 'Angioedema'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]",2.0,0.0225723,Treatment was accompanied by a reduction in the angioedema attack rate.,"[{'ForeName': 'Danny M', 'Initials': 'DM', 'LastName': 'Cohn', 'Affiliation': 'From the Departments of Vascular Medicine (D.M.C., L.M.F., E.S.G.S.) and Experimental Vascular Medicine (J.C.M.M.), Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, and the Department of Molecular and Cellular Hemostasis, Sanquin Research (J.C.M.M.), Amsterdam; Ionis Pharmaceuticals, Carlsbad, CA (N.J.V., E.S., V.J.A., S.X., G.E.K., C.N., B.F.B., R.S.G.); and the Department of Medicine, University College London Hospitals NHS Foundation Trust, and the Cardiometabolic Programme, National Institute for Health Research University College London Hospitals and University College London Biomedical Research Centre, London (M.L.).'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Viney', 'Affiliation': 'From the Departments of Vascular Medicine (D.M.C., L.M.F., E.S.G.S.) and Experimental Vascular Medicine (J.C.M.M.), Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, and the Department of Molecular and Cellular Hemostasis, Sanquin Research (J.C.M.M.), Amsterdam; Ionis Pharmaceuticals, Carlsbad, CA (N.J.V., E.S., V.J.A., S.X., G.E.K., C.N., B.F.B., R.S.G.); and the Department of Medicine, University College London Hospitals NHS Foundation Trust, and the Cardiometabolic Programme, National Institute for Health Research University College London Hospitals and University College London Biomedical Research Centre, London (M.L.).'}, {'ForeName': 'Lauré M', 'Initials': 'LM', 'LastName': 'Fijen', 'Affiliation': 'From the Departments of Vascular Medicine (D.M.C., L.M.F., E.S.G.S.) and Experimental Vascular Medicine (J.C.M.M.), Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, and the Department of Molecular and Cellular Hemostasis, Sanquin Research (J.C.M.M.), Amsterdam; Ionis Pharmaceuticals, Carlsbad, CA (N.J.V., E.S., V.J.A., S.X., G.E.K., C.N., B.F.B., R.S.G.); and the Department of Medicine, University College London Hospitals NHS Foundation Trust, and the Cardiometabolic Programme, National Institute for Health Research University College London Hospitals and University College London Biomedical Research Centre, London (M.L.).'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Schneider', 'Affiliation': 'From the Departments of Vascular Medicine (D.M.C., L.M.F., E.S.G.S.) and Experimental Vascular Medicine (J.C.M.M.), Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, and the Department of Molecular and Cellular Hemostasis, Sanquin Research (J.C.M.M.), Amsterdam; Ionis Pharmaceuticals, Carlsbad, CA (N.J.V., E.S., V.J.A., S.X., G.E.K., C.N., B.F.B., R.S.G.); and the Department of Medicine, University College London Hospitals NHS Foundation Trust, and the Cardiometabolic Programme, National Institute for Health Research University College London Hospitals and University College London Biomedical Research Centre, London (M.L.).'}, {'ForeName': 'Veronica J', 'Initials': 'VJ', 'LastName': 'Alexander', 'Affiliation': 'From the Departments of Vascular Medicine (D.M.C., L.M.F., E.S.G.S.) and Experimental Vascular Medicine (J.C.M.M.), Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, and the Department of Molecular and Cellular Hemostasis, Sanquin Research (J.C.M.M.), Amsterdam; Ionis Pharmaceuticals, Carlsbad, CA (N.J.V., E.S., V.J.A., S.X., G.E.K., C.N., B.F.B., R.S.G.); and the Department of Medicine, University College London Hospitals NHS Foundation Trust, and the Cardiometabolic Programme, National Institute for Health Research University College London Hospitals and University College London Biomedical Research Centre, London (M.L.).'}, {'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'From the Departments of Vascular Medicine (D.M.C., L.M.F., E.S.G.S.) and Experimental Vascular Medicine (J.C.M.M.), Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, and the Department of Molecular and Cellular Hemostasis, Sanquin Research (J.C.M.M.), Amsterdam; Ionis Pharmaceuticals, Carlsbad, CA (N.J.V., E.S., V.J.A., S.X., G.E.K., C.N., B.F.B., R.S.G.); and the Department of Medicine, University College London Hospitals NHS Foundation Trust, and the Cardiometabolic Programme, National Institute for Health Research University College London Hospitals and University College London Biomedical Research Centre, London (M.L.).'}, {'ForeName': 'Gwendolyn E', 'Initials': 'GE', 'LastName': 'Kaeser', 'Affiliation': 'From the Departments of Vascular Medicine (D.M.C., L.M.F., E.S.G.S.) and Experimental Vascular Medicine (J.C.M.M.), Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, and the Department of Molecular and Cellular Hemostasis, Sanquin Research (J.C.M.M.), Amsterdam; Ionis Pharmaceuticals, Carlsbad, CA (N.J.V., E.S., V.J.A., S.X., G.E.K., C.N., B.F.B., R.S.G.); and the Department of Medicine, University College London Hospitals NHS Foundation Trust, and the Cardiometabolic Programme, National Institute for Health Research University College London Hospitals and University College London Biomedical Research Centre, London (M.L.).'}, {'ForeName': 'Charvi', 'Initials': 'C', 'LastName': 'Nanavati', 'Affiliation': 'From the Departments of Vascular Medicine (D.M.C., L.M.F., E.S.G.S.) and Experimental Vascular Medicine (J.C.M.M.), Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, and the Department of Molecular and Cellular Hemostasis, Sanquin Research (J.C.M.M.), Amsterdam; Ionis Pharmaceuticals, Carlsbad, CA (N.J.V., E.S., V.J.A., S.X., G.E.K., C.N., B.F.B., R.S.G.); and the Department of Medicine, University College London Hospitals NHS Foundation Trust, and the Cardiometabolic Programme, National Institute for Health Research University College London Hospitals and University College London Biomedical Research Centre, London (M.L.).'}, {'ForeName': 'Brenda F', 'Initials': 'BF', 'LastName': 'Baker', 'Affiliation': 'From the Departments of Vascular Medicine (D.M.C., L.M.F., E.S.G.S.) and Experimental Vascular Medicine (J.C.M.M.), Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, and the Department of Molecular and Cellular Hemostasis, Sanquin Research (J.C.M.M.), Amsterdam; Ionis Pharmaceuticals, Carlsbad, CA (N.J.V., E.S., V.J.A., S.X., G.E.K., C.N., B.F.B., R.S.G.); and the Department of Medicine, University College London Hospitals NHS Foundation Trust, and the Cardiometabolic Programme, National Institute for Health Research University College London Hospitals and University College London Biomedical Research Centre, London (M.L.).'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Geary', 'Affiliation': 'From the Departments of Vascular Medicine (D.M.C., L.M.F., E.S.G.S.) and Experimental Vascular Medicine (J.C.M.M.), Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, and the Department of Molecular and Cellular Hemostasis, Sanquin Research (J.C.M.M.), Amsterdam; Ionis Pharmaceuticals, Carlsbad, CA (N.J.V., E.S., V.J.A., S.X., G.E.K., C.N., B.F.B., R.S.G.); and the Department of Medicine, University College London Hospitals NHS Foundation Trust, and the Cardiometabolic Programme, National Institute for Health Research University College London Hospitals and University College London Biomedical Research Centre, London (M.L.).'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Levi', 'Affiliation': 'From the Departments of Vascular Medicine (D.M.C., L.M.F., E.S.G.S.) and Experimental Vascular Medicine (J.C.M.M.), Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, and the Department of Molecular and Cellular Hemostasis, Sanquin Research (J.C.M.M.), Amsterdam; Ionis Pharmaceuticals, Carlsbad, CA (N.J.V., E.S., V.J.A., S.X., G.E.K., C.N., B.F.B., R.S.G.); and the Department of Medicine, University College London Hospitals NHS Foundation Trust, and the Cardiometabolic Programme, National Institute for Health Research University College London Hospitals and University College London Biomedical Research Centre, London (M.L.).'}, {'ForeName': 'Joost C M', 'Initials': 'JCM', 'LastName': 'Meijers', 'Affiliation': 'From the Departments of Vascular Medicine (D.M.C., L.M.F., E.S.G.S.) and Experimental Vascular Medicine (J.C.M.M.), Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, and the Department of Molecular and Cellular Hemostasis, Sanquin Research (J.C.M.M.), Amsterdam; Ionis Pharmaceuticals, Carlsbad, CA (N.J.V., E.S., V.J.A., S.X., G.E.K., C.N., B.F.B., R.S.G.); and the Department of Medicine, University College London Hospitals NHS Foundation Trust, and the Cardiometabolic Programme, National Institute for Health Research University College London Hospitals and University College London Biomedical Research Centre, London (M.L.).'}, {'ForeName': 'Erik S G', 'Initials': 'ESG', 'LastName': 'Stroes', 'Affiliation': 'From the Departments of Vascular Medicine (D.M.C., L.M.F., E.S.G.S.) and Experimental Vascular Medicine (J.C.M.M.), Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, and the Department of Molecular and Cellular Hemostasis, Sanquin Research (J.C.M.M.), Amsterdam; Ionis Pharmaceuticals, Carlsbad, CA (N.J.V., E.S., V.J.A., S.X., G.E.K., C.N., B.F.B., R.S.G.); and the Department of Medicine, University College London Hospitals NHS Foundation Trust, and the Cardiometabolic Programme, National Institute for Health Research University College London Hospitals and University College London Biomedical Research Centre, London (M.L.).'}]",The New England journal of medicine,['10.1056/NEJMoa1915035']
2679,33061884,"Efficacy of  Labisia pumila  and  Eurycoma longifolia  standardised extracts on hot flushes, quality of life, hormone and lipid profile of peri-menopausal and menopausal women: a randomised, placebo-controlled study.","Background


Interest in herbal medicines and non-hormonal therapies for the treatment of menopausal symptoms has increased since the publication of adverse effects of estrogen replacement therapy. Vasomotor symptoms are the most characteristic and notable symptoms of menopause.
Objective


To investigate the changes in the frequency and severity of hot flush and associated vasomotor symptoms experienced by peri-menopausal and menopausal women supplemented with the herbal formulation (Nu-femme™) comprising  Labisia pumila  (SLP+ ® ) and  Eurycoma longifolia  (Physta ® ) or placebo.
Design


Randomised, double-blind, placebo-controlled, 24-week study enrolled 119 healthy women aged 41-55 years experiencing peri-menopausal or menopausal symptoms and supplemented with Nu-femme™ or placebo. The primary endpoint was comparative changes between treatment groups in the change in the frequency and severity of hot flushes. The secondary objectives were to assess the changes in the frequency and severity of joint pain, Menopause Rating Scale (MRS) and Menopause-Specific Quality of Life (MENQOL) questionnaire domain scores. Concentrations of serum hormone, lipid profile, bone markers, sleep quality and vitality were also studied as secondary objectives.
Results


At week 12, significant ( P  < 0.01) improvements in hot flush symptoms were observed in Nu-femme™ and placebo groups. Even though there was no significant difference between groups, higher percentage of improvement, 65%, was seen in Nu-femme™ compared to 60% in placebo. Significant improvements ( P  < 0.001) in MRS and MENQOL scores at weeks 12 and 24 were observed in both groups, respectively. Luteinising hormone and follicle-stimulating hormone levels were significantly reduced ( P  < 0.05) at weeks 12 and 24, respectively, compared to baseline in the Nu-femme™ group, with no significant changes observed in the placebo group. There were significant ( P  < 0.05) reductions in serum low-density lipid and triglycerides levels at week 12 in Nu-femme™ group, but no changes seen in placebo group. At the end of week 24, changes in haematology and clinical chemistry parameters remained within normal clinical ranges in both groups.
Conclusion


Herbal formulation consists of  L. pumila  and  E. longifolia  (Nu-femme™) may support reduction in hot flushes and improvements in hormone and lipid profile in healthy peri-menopausal and menopausal women.",2020,"There were significant ( P  < 0.05) reductions in serum low-density lipid and triglycerides levels at week 12 in Nu-femme™ group, but no changes seen in placebo group.","['peri-menopausal and menopausal women', 'healthy peri-menopausal and menopausal women', '119 healthy women aged 41-55 years experiencing peri-menopausal or menopausal symptoms and supplemented with Nu-femme™ or']","['peri-menopausal and menopausal women supplemented with the herbal formulation (Nu-femme™) comprising  Labisia pumila  (SLP+ ® ) and  Eurycoma longifolia  (Physta ® ) or placebo', 'placebo', 'Labisia pumila  and']","['frequency and severity of hot flushes', 'Concentrations of serum hormone, lipid profile, bone markers, sleep quality and vitality', 'serum low-density lipid and triglycerides levels', 'frequency and severity of joint pain, Menopause Rating Scale (MRS) and Menopause-Specific Quality of Life (MENQOL) questionnaire domain scores', 'MRS and MENQOL scores', 'haematology and clinical chemistry parameters', 'hot flushes, quality of life, hormone and lipid profile', 'Luteinising hormone and follicle-stimulating hormone levels', 'Vasomotor symptoms', 'hormone and lipid profile', 'hot flush symptoms']","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C1258070', 'cui_str': 'Long Jack'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274119', 'cui_str': 'Hematopathology'}, {'cui': 'C0008000', 'cui_str': 'Clinical Chemistry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",119.0,0.287503,"There were significant ( P  < 0.05) reductions in serum low-density lipid and triglycerides levels at week 12 in Nu-femme™ group, but no changes seen in placebo group.","[{'ForeName': 'Sasikala M', 'Initials': 'SM', 'LastName': 'Chinnappan', 'Affiliation': 'Biotropics Malaysia Berhad, Section U1Hicom Glenmarie, Industrial Park Shah Alam, Selangor, Malaysia.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'George', 'Affiliation': 'Biotropics Malaysia Berhad, Section U1Hicom Glenmarie, Industrial Park Shah Alam, Selangor, Malaysia.'}, {'ForeName': 'Malkanthi', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'KGK Science, London, ON, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Anthony', 'Affiliation': 'KGK Science, London, ON, Canada.'}]",Food & nutrition research,['10.29219/fnr.v64.3665']
2680,33061895,Right Temporoparietal Junction Modulates In-Group Bias in Facial Emotional Mimicry: A tDCS Study.,"The present study employs transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, to explore the possible role of the right temporoparietal junction (rTPJ) in regulating in-group bias in facial emotional mimicry. Participants received either anodal or cathodal stimulation, or they were assigned to a sham condition. After that, they passively viewed a series of video clips depicting different emotions (happiness and anger) that were performed either by ethnic in-group or out-group models. The emotion-specific muscle activities, zygomatic major (ZM) and corrugator supercilii (CS) were recorded simultaneously as the index of facial emotional mimicry. The results first confirm the in-group bias in facial emotional mimicry in the sham condition, as shown in prior studies, though it only occurs in happy mimicry. Moreover, the in-group bias in facial emotional mimicry is modulated by the cortical excitability over the rTPJ, which may be attributed to the accompanied change of overlap of the mental representations of in-group and out-group. This study provides a close look at the neural underpinning of the modulation of facial emotional mimicry by group membership and highlights the role of rTPJ in on-line control of co-activated self and other representations in social cognition.",2020,"The emotion-specific muscle activities, zygomatic major (ZM) and corrugator supercilii (CS) were recorded simultaneously as the index of facial emotional mimicry.",['Facial Emotional Mimicry'],"['right temporoparietal junction (rTPJ', 'anodal or cathodal stimulation', 'rTPJ', 'transcranial direct current stimulation (tDCS']","['emotion-specific muscle activities, zygomatic major (ZM) and corrugator supercilii (CS', 'facial emotional mimicry']","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233577', 'cui_str': 'Mimicry'}]","[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0224127', 'cui_str': 'Structure of corrugator supercilii muscle'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0233577', 'cui_str': 'Mimicry'}]",,0.0259309,"The emotion-specific muscle activities, zygomatic major (ZM) and corrugator supercilii (CS) were recorded simultaneously as the index of facial emotional mimicry.","[{'ForeName': 'Shenli', 'Initials': 'S', 'LastName': 'Peng', 'Affiliation': 'College of Education, Hunan Agricultural University, Changsha, China.'}, {'ForeName': 'BeiBei', 'Initials': 'B', 'LastName': 'Kuang', 'Affiliation': 'The Institute for Mental Crisis Prevention and Intervention of College Students in Jiangsu Province, Nanjing Audit University, Nanjing, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Hu', 'Affiliation': 'Department of Psychology, Renmin University of China, Beijing, China.'}]",Frontiers in behavioral neuroscience,['10.3389/fnbeh.2020.00143']
2681,33061909,A Randomized Study of Food Pictures-Influenced Decision-Making Under Ambiguity in Individuals With Morbid Obesity.,"Background and Aims


In addition to craving responses to salient food cues, the anticipation of short-term rewarding consumption of palatable food may overrun the anticipation of long-term negative consequences of obesity. The present investigation addressed the potential interplay of food cravings and decision-making abilities in individuals with obesity.
Method


Study 1 included 107 bariatric surgery candidates with class 2/3 obesity (OB-group) and study 2 included 54 individuals with normal weight/pre-obesity (nonOB-group). In both studies, standardized questionnaires concerning food cravings, food addiction, and psychopathology were administered. A cue-reactivity paradigm was used to measure craving responses toward semi-individualized images of highly palatable, processed food/fruit (appetitive food cues) compared to images of raw vegetables (non-appetitive food cues). Decision-making was measured with a modified computerized version of the Iowa Gambling Task (IGT) with food pictures. Both groups were divided into two subgroups that were randomized to different IGT conditions. In one IGT condition the advantageous IGT card decks were covered by pictures of palatable, processed food or fruit and the disadvantageous decks by images of raw vegetables (= congruent condition), and in the other IGT condition  vice versa .
Results


Participants in the OB-group admitted on average higher craving responses toward palatable, processed food or fruit cues compared to pictures of raw vegetables. This was not the case in the nonOB-group. Contrary to our hypothesis, decision-making performance in both groups was worse when pictures of palatable, processed food or fruit were associated with advantageous IGT card decks compared to performance when those pictures were linked to the disadvantageous decks. The interference effect of food pictures processing on advantageous decision-making has been observed particularly in those individuals of the OB-group who exhibited high craving responses toward palatable, processed food cues or high levels of food addiction.
Discussion


The results indicate that food pictures processing interferes with decision-making, regardless of weight status. Opposed to the hypothesis, stronger tendencies to avoid than to approach pictures presenting processed, tasty food were observed. Further research should examine how cognitive avoidance tendencies toward processed, high energy food and approach tendencies toward healthy food can be transferred to real life situations.",2020,"Participants in the OB-group admitted on average higher craving responses toward palatable, processed food or fruit cues compared to pictures of raw vegetables.","['107 bariatric surgery candidates with class 2/3 obesity (OB-group) and study 2 included 54 individuals with normal weight/pre-obesity (nonOB-group', 'Individuals With Morbid Obesity', 'individuals with obesity']",['Food Pictures-Influenced Decision-Making'],"['food pictures processing interferes with decision-making, regardless of weight status', 'standardized questionnaires concerning food cravings, food addiction, and psychopathology']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",,0.0185341,"Participants in the OB-group admitted on average higher craving responses toward palatable, processed food or fruit cues compared to pictures of raw vegetables.","[{'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Lescher', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Wegmann', 'Affiliation': 'General Psychology: Cognition and Center for Behavioral Addiction Research (CeBAR), University of Duisburg-Essen, Duisburg, Germany.'}, {'ForeName': 'Silke M', 'Initials': 'SM', 'LastName': 'Müller', 'Affiliation': 'General Psychology: Cognition and Center for Behavioral Addiction Research (CeBAR), University of Duisburg-Essen, Duisburg, Germany.'}, {'ForeName': 'Nora M', 'Initials': 'NM', 'LastName': 'Laskowski', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Wunder', 'Affiliation': 'Surgical Department, Clementinenhaus, Hannover, Germany.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Jiménez-Murcia', 'Affiliation': 'Department of Psychiatry, University Hospital Bellvitge-IDIBELL and CIBEROBN, Barcelona, Spain.'}, {'ForeName': 'Gregor R', 'Initials': 'GR', 'LastName': 'Szycik', 'Affiliation': 'Department of Psychiatry, Social Psychiatry and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'de Zwaan', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Müller', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00822']
2682,33062236,Rationale and design of the expanded combination of evolocumab plus empagliflozin in diabetes: EXCEED-BHS3 trial.,"Background


Patients with type 2 diabetes mellitus (T2DM) remain at increased cardiovascular residual risk and endothelial dysfunction, even after optimizing metabolic control and treatment by sodium-glucose-2 transporter inhibitors (SGLT2-is). The present study was based on the hypothesis that proprotein convertase subtilisin/kexin 9 inhibitor (PCSK9i) therapy may mitigate endothelial dysfunction in T2DM patients who are on regular treatment by SGLT2-i.
Methods


The EXCEED-BHS3 is a prospective, single-center, investigator-blinded, open-label, randomized clinical trial. Participants ( n  = 110) will be randomized (1:1) to either empagliflozin 25 mg/day alone or empagliflozin 25 mg/day plus evolocumab 140 mg every 2 weeks in addition to optimal medical care. The primary endpoint was defined as the change in the 1-min flow-mediated dilation (FMD) after 16 weeks of treatment. The secondary endpoint is the FMD change after ischemia/reperfusion injury protocol (reserve FMD) after 16 weeks of treatment. Exploratory outcomes comprise the change in FMD and reserve FMD after 8 weeks of treatment and the change after 16 weeks of treatment in the following parameters: plasma levels of nitric oxide, vascular cell adhesion molecule-1 and isoprostane, high-density lipoprotein (HDL) and low-density lipoprotein subfractions profile, HDL function, blood pressure, body mass index, waist circumference and adipokines.
Conclusion


This will be the first study to evaluate the add-on effect of PCSK9i on endothelial function of T2DM patients under regular use of empagliflozin.
Trial registration


ClinicalTrials.gov identifier: NCT03932721.",2020,The primary endpoint was defined as the change in the 1-min flow-mediated dilation (FMD) after 16 weeks of treatment.,"['\n\n\nPatients with type 2 diabetes mellitus (T2DM', 'T2DM patients under regular use of', 'diabetes', 'T2DM patients who are on regular treatment by SGLT2-i.\nMethods\n\n\nThe EXCEED-BHS3', 'Participants ( n \u2009=\u2009110']","['empagliflozin', 'empagliflozin 25\u2009mg/day alone or empagliflozin 25\u2009mg/day plus evolocumab 140\u2009mg every 2\u2009weeks in addition to optimal medical care', 'PCSK9i', 'evolocumab plus empagliflozin', 'proprotein convertase subtilisin/kexin 9 inhibitor (PCSK9i) therapy']","['change in the 1-min flow-mediated dilation (FMD', 'plasma levels of nitric oxide, vascular cell adhesion molecule-1 and isoprostane, high-density lipoprotein (HDL) and low-density lipoprotein subfractions profile, HDL function, blood pressure, body mass index, waist circumference and adipokines', 'FMD change after ischemia/reperfusion injury protocol (reserve FMD', 'change in FMD and reserve FMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1505133', 'cui_str': 'SLC5A2 protein, human'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3848772', 'cui_str': 'empagliflozin 25 MG [Jardiance]'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C1100660', 'cui_str': 'Proprotein Convertase'}, {'cui': 'C0038601', 'cui_str': 'Subtilisins'}, {'cui': 'C0165249', 'cui_str': 'Kexin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0949860', 'cui_str': 'Isoprostane'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0578543', 'cui_str': 'Low density lipoprotein subfraction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",,0.0973208,The primary endpoint was defined as the change in the 1-min flow-mediated dilation (FMD) after 16 weeks of treatment.,"[{'ForeName': 'Ikaro', 'Initials': 'I', 'LastName': 'Breder', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Cunha Breder', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Bonilha', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Munhoz', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Sheila T Kimura', 'Initials': 'STK', 'LastName': 'Medorima', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Daniela C', 'Initials': 'DC', 'LastName': 'Oliveira', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Helison R', 'Initials': 'HR', 'LastName': 'do Carmo', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Moreira', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Anatol', 'Initials': 'A', 'LastName': 'Kontush', 'Affiliation': 'UMR-ICAN 1166, National Institute for Health and Medical Research (INSERM), Sorbonne University, Paris, France.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Zimetti', 'Affiliation': 'Department of Food and Drugs, University of Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Zanotti', 'Affiliation': 'Department of Food and Drugs, University of Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Luiz Sergio F', 'Initials': 'LSF', 'LastName': 'Carvalho', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Nadruz', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Elza', 'Initials': 'E', 'LastName': 'Muscelli', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Quinaglia', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Andrei C', 'Initials': 'AC', 'LastName': 'Sposito', 'Affiliation': 'Brazilian Heart Study Group, Cardiology Division, State University of Campinas, Rua Tessália Vieira de Camargo, 126., Cidade Universitária Zeferino Vaz, Campinas, São Paulo, 13084-971, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Therapeutic advances in chronic disease,['10.1177/2040622320959248']
2683,33062268,Erratum: Oral intake of royal jelly improves anti-cancer effects and suppresses adverse events of molecular targeted therapy by regulating TNF-α and TGF-β in renal cell carcinoma: A preliminary study based on a randomized double-blind clinical trial.,[This corrects the article DOI: 10.3892/mco.2020.2099.].,2020,[This corrects the article DOI: 10.3892/mco.2020.2099.].,['renal cell carcinoma'],"['TNF-α and TGF-β', 'royal jelly']",['anti-cancer effects'],"[{'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}]","[{'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0073603', 'cui_str': 'royal jelly'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.458587,[This corrects the article DOI: 10.3892/mco.2020.2099.].,"[{'ForeName': 'Yasuyoshi', 'Initials': 'Y', 'LastName': 'Miyata', 'Affiliation': ''}, {'ForeName': 'Kyohei', 'Initials': 'K', 'LastName': 'Araki', 'Affiliation': ''}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Ohba', 'Affiliation': ''}, {'ForeName': 'Tomhiro', 'Initials': 'T', 'LastName': 'Mastuo', 'Affiliation': ''}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': ''}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Yuno', 'Affiliation': ''}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Mukai', 'Affiliation': ''}, {'ForeName': 'Asato', 'Initials': 'A', 'LastName': 'Otsubo', 'Affiliation': ''}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Mitsunari', 'Affiliation': ''}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Mochizuki', 'Affiliation': ''}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Sakai', 'Affiliation': ''}]",Molecular and clinical oncology,['10.3892/mco.2020.2148']
2684,33062284,"The effects of exergaming on pain, postural control, technology acceptance and flow experience in older people with chronic musculoskeletal pain: a randomised controlled trial.","Background


Older people with chronic musculoskeletal pain are at risk of falls. This study aimed to investigate the effects of exergaming on pain and postural control in older people with chronic musculoskeletal pain. Secondary outcomes were technology acceptance, flow experience, perceived physical exertion, expended mental effort and heart rate.
Methods


Fifty four older adults (age: 71 ± 5 years) with chronic musculoskeletal pain were randomised into 2 groups. Group 1 received exergaming training using the Interactive Rehabilitation and Exercise System (IREX®). Group 2 undertook traditional gym-based exercise (TGB). Both groups completed twice weekly 40-min exercise sessions for 6 weeks. Perceived pain was measured using a numeric pain rating scale and the Multidimensional Affect and Pain Survey questionnaire. Postural control was measured as sway using a Kistler™ force platform. Technology acceptance was measured with the Unified Theory of Acceptance and Use of Technology questionnaire and flow experience with the Flow State Scale. Physiological measures of perceived physical exertion, expended mental effort and heart rate were recorded during all sessions.
Results


The exergaming group demonstrated significant reductions in pain intensity and thermal pain including a near significant approach in physical engagement in comparison to TGB group. Although no intervention effects on postural control were found, the exergaming group showed significant improvements in three sway measures (AP SD, ML SD and AP range) over time whereas significant improvements in ML range were found in the TGB group. Relating to technology acceptance, significant intervention effects on social influence and behavioural intention were found in the TGB group instead, although both groups demonstrated increases of acceptance over time. Regarding flow experience, concentration at task was significantly influenced in the TGB group and significant increases in flow variables over time were observed in both groups. Significant increases over time in perceived physical exertion and expended mental effort were found in both groups.
Conclusion


Our findings support the potential of exergaming to alleviate pain and improve balance in older people with chronic musculoskeletal pain. Both forms of exercise are acceptable, intrinsically motivating and show evidence of benefit to older people with chronic musculoskeletal pain.
Trial registration


ClinicalTrials.gov Identifier: NCT04029285 (retrospectively registered, July 23, 2019).",2020,"Although no intervention effects on postural control were found, the exergaming group showed significant improvements in three sway measures (AP SD, ML SD and AP range) over time whereas significant improvements in ML range were found in the TGB group.","['\n\n\nOlder people with chronic musculoskeletal pain', 'older people with chronic musculoskeletal pain', 'four older adults (age: 71\u2009±\u20095\u2009years) with chronic musculoskeletal pain']","['traditional gym-based exercise (TGB', 'TGB', 'exergaming training using the Interactive Rehabilitation and Exercise System (IREX®']","['technology acceptance, flow experience, perceived physical exertion, expended mental effort and heart rate', 'postural control', 'numeric pain rating scale and the Multidimensional Affect and Pain Survey questionnaire', 'pain, postural control, technology acceptance and flow experience', 'Technology acceptance', 'three sway measures (AP SD, ML SD and AP range', 'social influence and behavioural intention', 'pain intensity and thermal pain', 'Physiological measures of perceived physical exertion, expended mental effort and heart rate', 'time in perceived physical exertion and expended mental effort', 'pain and postural control', 'physical engagement', 'Postural control', 'Perceived pain']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0031807', 'cui_str': 'Physical Effort'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",54.0,0.0811072,"Although no intervention effects on postural control were found, the exergaming group showed significant improvements in three sway measures (AP SD, ML SD and AP range) over time whereas significant improvements in ML range were found in the TGB group.","[{'ForeName': 'Jae-Llane', 'Initials': 'JL', 'LastName': 'Ditchburn', 'Affiliation': 'Institute of Science, Natural Resources and Outdoor Studies, University of Cumbria, Fusehill Street, Carlisle, Cumbria, CA1 2HH UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'van Schaik', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BA UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Dixon', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX UK.'}, {'ForeName': 'Alasdair', 'Initials': 'A', 'LastName': 'MacSween', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX UK.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX UK.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00211-x']
2685,33062294,"Implementation of a trauma-informed, evidence-informed intervention for Latinx families experiencing interpersonal violence and child maltreatment: protocol for a pilot randomized control trial of SafeCare+®.","Background


A consistently demonstrated overlap exists between the occurrence of domestic violence and child maltreatment, yet these issues are historically addressed by distinct systems and programming. The randomized control trial pilot study presented in this article adapts, implements, and tests a new approach for addressing family violence for Latinx families with co-occurring risk for domestic violence and child maltreatment. In doing so, this pilot study addresses the clear need for collaboration between the two fields and focuses on Latinx families, who often face specific challenges regarding seeking and receiving needed services. The primary aim of the current study is a pilot implementation of SafeCare+®, an evidence-based parenting curriculum (SafeCare®) augmented with a healthy relationships curriculum (SafeCare+®). The objectives are a reduction of family violence, improved communication, and a healthy home environment for children in Latinx families with co-occurring domestic violence and child maltreatment.
Methods


This protocol outlines a feasibility, randomized control trial to examine the potential efficacy of SafeCare+. The pilot study is divided into two phases. Components of phase one involve developing a detailed implementation and evaluation plan, including a community needs assessment, determining screening and outcome measures, and assuring all components are culturally appropriate for the target population. Phase two implements the randomization of parents, who are involved in the child welfare system and referred for in-home parenting services, into SafeCare+ or SafeCare as usual. Participants complete assessments regarding mental health, provider-parent relationship, interpersonal violence experiences, and fidelity to the intervention. Analyses will focus on improvement on target outcomes for the intervention group, as well as comparison to the control group.
Discussion


This study will provide evidence on the feasibility and potential effectiveness of an early intervention program aimed at improving communication skills and mental health and reducing incidents of violence for Latinx parents who are involved with the child welfare service system. The findings of the study will inform the decision to progress to a full scale, definitive randomized control trial to test the effectiveness of an intervention, delivered as part of home visitation, for improving outcomes for families with histories of domestic violence.
Trial registration


ClinicalTrials.gov, NCT03041558; registered 2 February, 2017-retrospectively registered.",2020,"The objectives are a reduction of family violence, improved communication, and a healthy home environment for children in Latinx families with co-occurring domestic violence and child maltreatment.
","['children in Latinx families with co-occurring domestic violence and child maltreatment', 'Latinx families experiencing interpersonal violence and child maltreatment', 'Latinx families with co-occurring risk for domestic violence and child maltreatment', 'Latinx parents who are involved with the child welfare service system', 'families with histories of domestic violence']","['SafeCare', 'SafeCare+®', 'SafeCare+®, an evidence-based parenting curriculum (SafeCare®) augmented with a healthy relationships curriculum (SafeCare+®']","['mental health, provider-parent relationship, interpersonal violence experiences, and fidelity to the intervention']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0206073', 'cui_str': 'Domestic violence'}, {'cui': 'C0008060', 'cui_str': 'Child abuse'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1445903', 'cui_str': 'History of domestic violence'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0622027,"The objectives are a reduction of family violence, improved communication, and a healthy home environment for children in Latinx families with co-occurring domestic violence and child maltreatment.
","[{'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Fettes', 'Affiliation': 'Department of Psychiatry, University of California, 9500 Gilman Drive, #0812, La Jolla, San Diego, CA 92093 USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Aarons', 'Affiliation': 'Department of Psychiatry, University of California, 9500 Gilman Drive, #0812, La Jolla, San Diego, CA 92093 USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Brew', 'Affiliation': 'South Bay Community Services, San Diego, CA USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Ledesma', 'Affiliation': 'South Bay Community Services, San Diego, CA USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Silovsky', 'Affiliation': 'Health Sciences Center, The University of Oklahoma, Oklahoma City, OK USA.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00681-3']
2686,33062295,Feasibility study on pre or postoperative accelerated radiotherapy (POP-ART) in breast cancer patients.,"Background


In early-stage breast cancer, the cornerstone of treatment is surgery. After breast-conserving surgery, adjuvant radiotherapy has shown to improve locoregional control and overall survival rates. The use of breast radiotherapy in the preoperative (preop) setting is far less common. Nevertheless, it might improve disease-free survival as compared to postoperative radiotherapy. There is also a possibility of downsizing the tumour which might lead to a lower need for mastectomy. There are some obstacles that complicate its introduction into daily practice. It may complicate surgery or lead to an increase in wound complications or delayed wound healing. Another fear of preop radiotherapy is delaying surgery for too long. At Ghent University Hospital, we have experience with a 5-fraction radiotherapy schedule allowing radiotherapy delivery in a very short time span.
Methods


Twenty female breast cancer patients with non-metastatic disease receiving preop chemotherapy will be randomized between preop or postoperative radiotherapy. The feasibility of preop radiotherapy will be evaluated based on overall treatment time. All patients will be treated in 5 fractions of 5.7 Gy to the whole breast with a simultaneous integrated boost to the tumour/tumour bed of 5 × 6.2 Gy. In case of lymph node irradiation, the lymph node regions will receive a dose of 27 Gy in 5 fractions of 5.4 Gy. The total duration of therapy will be 10 to 12 days. In the preop group, overall treatment time is defined as the time between diagnosis and the day of last surgery, in the postop group between diagnosis and last irradiation fraction. Toxicity related to surgery, radio-, and chemotherapy will be evaluated on dedicated case-report forms at predefined time points. Tumour response will be evaluated on the pathology report and on MRI at baseline and in the interval between chemotherapy and surgery.
Discussion


The primary objective of the trial is to investigate the feasibility of preop radiotherapy. Secondary objectives are to search for biomarkers of response and toxicity and identify the involved cell death mechanisms and the effect of preop breast radiotherapy on the in-situ immune micro-environment.",2020,"After breast-conserving surgery, adjuvant radiotherapy has shown to improve locoregional control and overall survival rates.","['Twenty female breast cancer patients with non-metastatic disease receiving preop', 'breast cancer patients']","['breast-conserving surgery, adjuvant radiotherapy', 'preop radiotherapy', 'postoperative radiotherapy', 'breast radiotherapy', 'pre or postoperative accelerated radiotherapy (POP-ART', 'chemotherapy']","['wound complications', 'total duration of therapy', 'locoregional control and overall survival rates', 'Toxicity', 'disease-free survival', 'overall treatment time']","[{'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0852216', 'cui_str': 'Breast radiotherapies'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",20.0,0.0506089,"After breast-conserving surgery, adjuvant radiotherapy has shown to improve locoregional control and overall survival rates.","[{'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Van Hulle', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vakaet', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Giselle', 'Initials': 'G', 'LastName': 'Post', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Van Greveling', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Monten', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Hendrix', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Van de Vijver', 'Affiliation': 'Department of Pathology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Van Dorpe', 'Affiliation': 'Department of Pathology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'De Visschere', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Braems', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'Vandecasteele', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Hannelore', 'Initials': 'H', 'LastName': 'Denys', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'De Neve', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Liv', 'Initials': 'L', 'LastName': 'Veldeman', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00693-z']
2687,33062629,Bioequivalence of the pharmacokinetics between tofacitinib aspartate and tofacitinib citrate in healthy subjects.,"Tofacitinib is an oral disease-modifying anti-rheumatic drug to selectively inhibit Janus kinases. Tofacitinib is a representative small molecule inhibitor that is used to treat many diseases including rheumatoid arthritis and various autoimmune conditions. Unlike biological agents, tofacitinib has several advantages, including the ability to be administered orally and a short half-life. This study aimed to evaluate the bioequivalence of the pharmacokinetics (PK) between tofacitinib aspartate 7.13 mg (test formulation) and tofacitinib citrate 8.08 mg (reference formulation; Xeljanz®) in healthy subjects. A randomized, open-label, single-dose, 2-sequence, 2-period, 2-treatment crossover trial was conducted in 41 healthy volunteers. A total of 5 mg of tofacitinib as the test or the reference formulation was administered, and serial blood samples were collected up to 14 hours after dosing for PK analyses. The plasma concentration of tofacitinib was determined by ultra-performance liquid chromatography-tandem mass spectrometry. A non-compartmental analysis was used to estimate the PK parameters. A total of 35 subjects completed the study and the study drug was well-tolerated. The mean maximum concentration (C max ) and area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC last ) for the test formulation were 52.67 ng/mL and 133.86 ng∙h/mL, respectively, and 50.61 ng/mL and 133.49 h∙ng/mL for the reference formulation, respectively. The geometric mean ratios (90% confidence intervals) of the C max  and AUC last  between the 2 formulations were 1.041 (0.944-1.148) and 1.003 (0.968-1.039), respectively. Tofacitinib aspartate exhibited bioequivalent PK profiles to those of the reference formulation.
Trial Registration


ClinicalTrials.gov Identifier: NCT04278391.",2020,"AUC last  between the 2 formulations were 1.041 (0.944-1.148) and 1.003 (0.968-1.039), respectively.","['41 healthy volunteers', '35 subjects completed the study and the study drug was well-tolerated', 'healthy subjects']","['Tofacitinib aspartate', 'tofacitinib aspartate and tofacitinib citrate', 'Tofacitinib', 'tofacitinib citrate 8.08 mg (reference formulation; Xeljanz®', 'tofacitinib']","['mean maximum concentration (C max ) and area under the concentration-time curve', 'geometric mean ratios', 'plasma concentration of tofacitinib']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0085845', 'cui_str': 'Aspartate'}, {'cui': 'C2987431', 'cui_str': 'Tofacitinib citrate'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C3505045', 'cui_str': 'Xeljanz'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}]",41.0,0.0899696,"AUC last  between the 2 formulations were 1.041 (0.944-1.148) and 1.003 (0.968-1.039), respectively.","[{'ForeName': 'Wonsuk', 'Initials': 'W', 'LastName': 'Shin', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam 13496, Korea.'}, {'ForeName': 'A-Young', 'Initials': 'AY', 'LastName': 'Yang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam 13496, Korea.'}, {'ForeName': 'Hyeonji', 'Initials': 'H', 'LastName': 'Yun', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam 13496, Korea.'}, {'ForeName': 'Doo-Yeoun', 'Initials': 'DY', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam 13496, Korea.'}, {'ForeName': 'Kyung Hee', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Clinical Development Center, Daewoong Pharmaceutical Co., Ltd., Seoul 06170, Korea.'}, {'ForeName': 'Hyunju', 'Initials': 'H', 'LastName': 'Shin', 'Affiliation': 'Formulation Research Team, Daewoong Pharmaceutical Co., Ltd., Seoul 06170, Korea.'}, {'ForeName': 'Anhye', 'Initials': 'A', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam 13496, Korea.'}]",Translational and clinical pharmacology,['10.12793/tcp.2020.28.e13']
2688,33062729,The effect of educational intervention on health-promoting lifestyle: Intervention mapping approach.,"BACKGROUND


The health-promoting lifestyle by empowering individuals will increase control over their health, improve quality of life, and prevent diseases. The purpose of the present study was to determine the effect of the educational intervention based on the intervention mapping approach on health-promoting lifestyle in Iranian college students.
METHODS


This study is a quasi-experimental control study that was conducted in two groups of 65 students of Iran University of Medical Sciences in 2018-2019. The data were collected using the Health-Promoting Lifestyle Standard Profile II questionnaire and a researcher-made questionnaire based on the mapping approach, whose validity and reliability were confirmed. The educational intervention was designed according to the pretest results, including five training sessions and performed for the intervention group. The two groups were evaluated with the same questionnaires 1 month and 3 months later, and the data were analyzed using independent  t -test, Spearman, ANCOVA, ANOVA test, and covariance.
Results


Before the intervention, no significant difference was observed between the mean scores of health-promoting behaviors in the two groups, but after the intervention, the mean scores of attitude, subjective norms, enabling factors, and perceived self-efficacy and mean scores of health-promoting lifestyle and its dimensions increased significantly in the intervention group ( P  < 0.001) compared to the control group.
Conclusion


The educational intervention is effective in improving behaviors related to health-promoting lifestyle and its dimensions. Therefore, performing educational interventions are suggested to adopt and adhere to behaviors related to health-promoting lifestyle by utilizing and reinforcing perceived self-efficacy, subjective norms, enabling factors, and attitudinal change.",2020,"Before the intervention, no significant difference was observed between the mean scores of health-promoting behaviors in the two groups, but after the intervention, the mean scores of attitude, subjective norms, enabling factors, and perceived self-efficacy and mean scores of health-promoting lifestyle and its dimensions increased significantly in the intervention group ( P  < 0.001) compared to the control group.
","['two groups of 65 students of Iran University of Medical Sciences in 2018-2019', 'Iranian college students']",['educational intervention'],"['mean scores of attitude, subjective norms, enabling factors, and perceived self-efficacy and mean scores of health-promoting lifestyle and its dimensions', 'health-promoting lifestyle', 'mean scores of health-promoting behaviors']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0557806', 'cui_str': 'College'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0014024', 'cui_str': 'Enabling Factors'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}]",,0.0137438,"Before the intervention, no significant difference was observed between the mean scores of health-promoting behaviors in the two groups, but after the intervention, the mean scores of attitude, subjective norms, enabling factors, and perceived self-efficacy and mean scores of health-promoting lifestyle and its dimensions increased significantly in the intervention group ( P  < 0.001) compared to the control group.
","[{'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Solhi', 'Affiliation': 'Air Pollution Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farbod Ebadi', 'Initials': 'FE', 'LastName': 'Fard Azar', 'Affiliation': 'Health Promotion Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Abolghasemi', 'Affiliation': 'Department of Biostatistics, School of Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Maheri', 'Affiliation': 'Department of Public Health, School of Health, Reproductive Health Research Center, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Seyed Fahim', 'Initials': 'SF', 'LastName': 'Irandoost', 'Affiliation': 'Department of Public Health, School of Health, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Saeede', 'Initials': 'S', 'LastName': 'Khalili', 'Affiliation': 'PhD Candidate of Education and Health Promotion, School of Health, Iran University of Medical Sciences, Tehran, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_768_19']
2689,33062730,Evaluating the effect of Pender's health promotion model on self-efficacy and treatment adherence behaviors among patients undergoing hemodialysis.,"INTRODUCTION


Health promotion through lifestyle improvement is an important topic that has received considerable attention from the scientific community worldwide. This study aimed to determine the effect of Pender's health promotion model on self-efficacy and treatment adherence behaviors of hemodialysis patients in Shahrekord, Iran, in 2018-2019.
METHODS


This quasi-experimental study was performed on 70 hemodialysis patients who were attending routine hemodialysis sessions in Hajar hospital in Shahrekord. Individuals were selected by simple random sampling and randomly assigned to two groups of control and intervention. In the preintervention stage, all patients completed a questionnaire that was prepared to collect demographic information and measure health-promoting behaviors, self-efficacy, and treatment adherence. The intervention group participated in eight sessions of a health promotion model-based education program. Both groups were asked to complete the questionnaire again immediately after the intervention and also 2 months later.
RESULTS


The repeated measures analysis of variance (ANOVA) showed a significant difference between the two groups in terms of the extent of change in mean scores over the three measurement stages (before the intervention, after the intervention, and 2 months after the intervention) ( P  < 0.001). A statistically significant difference was observed between the two groups in terms of self-efficacy scores in the postintervention and follow-up stages ( P  < 0.05). The repeated measures ANOVA also revealed a significant difference between the two groups in terms of the extent of change in mean treatment adherence scores over the three measurement stages ( P  < 0.001).
CONCLUSION


Considering the positive effects of the program on patients undergoing hemodialysis, it is recommended to use the program to promote the well-being of these patients without time restrictions.",2020,A statistically significant difference was observed between the two groups in terms of self-efficacy scores in the postintervention and follow-up stages ( P  < 0.05).,"['patients undergoing hemodialysis', 'hemodialysis patients in Shahrekord, Iran, in 2018-2019', '70 hemodialysis patients who were attending routine hemodialysis sessions in Hajar hospital in Shahrekord']","[""Pender's health promotion model"", 'health promotion model-based education program']","['self-efficacy scores', 'self-efficacy and treatment adherence behaviors', 'collect demographic information and measure health-promoting behaviors, self-efficacy, and treatment adherence', 'mean treatment adherence scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",70.0,0.0174381,A statistically significant difference was observed between the two groups in terms of self-efficacy scores in the postintervention and follow-up stages ( P  < 0.05).,"[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Masoudi', 'Affiliation': 'Community-Oriented Nursing Midwifery Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Lotfizade', 'Affiliation': 'Social Determinants of Health Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Gheysarieha', 'Affiliation': 'Department of Health Education and Health Promotion, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Rabiei', 'Affiliation': 'Social Determinants of Health Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_747_19']
2690,33062733,The impact of education on attachment skills in the promotion of happiness among women with unplanned pregnancy.,"BACKGROUND


Happiness is among the factors that promote mental health in mothers with unplanned pregnancy. The present study aimed to determine the impact of attachment skills training on happiness among women with unplanned pregnancy.
MATERIALS AND METHODS


This clinical trial was conducted on 84 women with unplanned pregnancy referred to three prenatal clinics in Shiraz in 2018. The participants were randomly divided into an intervention group and a control group using permutation block. At first, the participants were requested to sign written informed consent form, demographic information form, and mental health questionnaire. Then, they were asked to complete Oxford Happiness Questionnaire and Cranley's Maternal-Fetal Attachment Scale. The intervention group received attachment training through six 90-min sessions, while the control group underwent the hospital's routine care. The two groups were required to fill out the study questionnaires once more after 4 weeks after the intervention. After all, the data were analyzed using Chi-square test, Fisher's exact test, independent  t -test, and ANOVA.
RESULTS


There was a significant difference between the two groups' pretest and posttest mean scores of happiness ( P  = 0.0001). The results showed that in the experimental group, pretraining and posttraining period mean scores were 89.64 (7.2) and 93.13 (6.09), respectively; while in the control group, pretraining and posttraining period mean scores were, respectively, 91.69 (9.96) and 91 (8.82). The difference between the two groups was statistically significant. No significant relationship was observed between happiness and the couples' occupations, number of pregnancies, and number of miscarriages in the two groups ( P  > 0.05).
CONCLUSION


The mean score of happiness increased after the training, being significantly different from that in the control group. Therefore, happiness is a changeable feature that can be promoted among pregnant women via interventional methods.",2020,"No significant relationship was observed between happiness and the couples' occupations, number of pregnancies, and number of miscarriages in the two groups ( P  > 0.05).
","['pregnant women via interventional methods', '84 women with unplanned pregnancy referred to three prenatal clinics in Shiraz in 2018', 'women with unplanned pregnancy', 'mothers with unplanned pregnancy']","['attachment skills training', ""attachment training through six 90-min sessions, while the control group underwent the hospital's routine care"", 'control group using permutation block']","['mean score of happiness', ""happiness and the couples' occupations, number of pregnancies, and number of miscarriages"", ""complete Oxford Happiness Questionnaire and Cranley's Maternal-Fetal Attachment Scale"", 'pretraining and posttraining period mean scores']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041747', 'cui_str': 'Unplanned pregnancy'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0600457', 'cui_str': 'Gravida'}, {'cui': 'C0429916', 'cui_str': 'Number of miscarriages'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",84.0,0.0415981,"No significant relationship was observed between happiness and the couples' occupations, number of pregnancies, and number of miscarriages in the two groups ( P  > 0.05).
","[{'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Hasanzadeh', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maasumeh', 'Initials': 'M', 'LastName': 'Kaviani', 'Affiliation': 'Department of Midwifery, Community Based Psychiatric Care Research Center, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Akbarzadeh', 'Affiliation': 'Department of Midwifery, Maternal-Fetal Medicine Research Center, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_740_19']
2691,33057314,Combined and intravenous administration of TXA reduces blood loss more than topical administration in primary total knee arthroplasty: A randomized clinical trial.,"AIM


To determine the most effective administration of tranexamic acid (TXA) in patients with primary total knee arthroplasty (TKA).
MATERIAL AND METHOD


We enrolled a total of 400 patients (154 men and 346 women) in this randomized trial (4 groups, each of 100 patients). The first group (IV1) had a single intravenous dose (15 mg TXA/kg) prior to skin incision. Group 2 (IV2) had TXA in 2 intravenous doses (15 mg TXA/kg): prior to skin incision and 6 hours after the first dose. Group 3 (TOP) had 2 g TXA in 50 mL of saline irrigated topically at the end of the surgery. The fourth group (COMB) combined IV1 and TOP regimens. We monitored the amount of total blood loss (TBL), haemoglobin drop, use of blood transfusions (BTs), and complications in each patient.
RESULTS


The amount of TBL was significantly lower in IV1, IV2 and COMB regimens compared to the TOP (P<0.0001). The lowest decrease in haemoglobin within 12 hours after surgery was observed in intravenous regimens (P=0.045). A significant difference in haemoglobin decrease on day 1 after the surgery was demonstrated in the COMB and intravenous regimens (P=0.011).
CONCLUSION


In primary TKA, it is preferable to administer TXA intravenously in two doses or in a combined regimen. Simple topical administration of TXA was not as effective and is indicated only in cases where systemic administration of TXA is contraindicated. No substantial complications occurred in either group of patients.",2020,The lowest decrease in haemoglobin within 12 hours after surgery was observed in intravenous regimens (P=0.045).,"['We enrolled a total of 400 patients (154 men and 346 women', 'patients with primary total knee arthroplasty (TKA', 'primary total knee arthroplasty']","['tranexamic acid (TXA', 'TXA']","['amount of TBL', 'haemoglobin', 'total blood loss (TBL), haemoglobin drop, use of blood transfusions (BTs), and complications in each patient', 'haemoglobin decrease', 'substantial complications', 'blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",400.0,0.068537,The lowest decrease in haemoglobin within 12 hours after surgery was observed in intravenous regimens (P=0.045).,"[{'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Lostak', 'Affiliation': 'Department of Orthopaedics, University Hospital Olomouc and Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Gallo', 'Affiliation': 'Department of Orthopaedics, University Hospital Olomouc and Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic.'}, {'ForeName': 'Lubos', 'Initials': 'L', 'LastName': 'Balaz', 'Affiliation': 'Department of Orthopaedics, University Hospital Olomouc and Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Zapletalova', 'Affiliation': 'Department of Medical Biophysics, Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic.'}]","Biomedical papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia",['10.5507/bp.2020.045']
2692,33057367,Higher iron stores and the HFE 187C>G variant delay onset of peripheral neuropathy during combination antiretroviral therapy.,"OBJECTIVE


People with HIV (PWH) continue to experience sensory neuropathy and neuropathic pain in the combination antiretroviral therapy (cART) era for unclear reasons. This study evaluated the role of iron in a previously reported association of iron-loading hemochromatosis (HFE) gene variants with reduced risk of neuropathy in PWH who received more neurotoxic cART, since an iron-related mechanism also might be relevant to neuropathic symptoms in PWH living in low-resource settings today.
DESIGN


This time-to-event analysis addressed the impact of systemic iron levels on the rapidity of neuropathy onset in PWH who initiated cART.
METHODS


Soluble transferrin receptor (sTFR), the sTFR-ferritin index of iron stores, and high-sensitivity C-reactive protein (hsCRP) levels were determined in stored baseline sera from participants of known HFE genotype from AIDS Clinical Trials Group (ACTG) Study 384, a multicenter randomized clinical trial that evaluated cART strategies. Associations with incident neuropathy were evaluated in proportional-hazards, time-to-event regression models, adjusting for potential confounders.
RESULTS


Of 151 eligible participants with stored serum who were included in the original genetic study, 43 had cART-associated neuropathy; 108 had sufficient serum for analysis, including 30 neuropathy cases. Carriers of HFE variants had higher systemic iron (lower sTFR and sTFR-ferritin index) and lower hsCRP levels than non-carriers (all p<0.05). Higher sTFR or iron stores, the HFE 187C>G variant, and lower baseline hsCRP were associated with significantly delayed neuropathy in self-reported whites (n = 28; all p-values<0.05), independent of age, CD4+ T-cell count, plasma HIV RNA, and cART regimen.
CONCLUSIONS


Higher iron stores, the HFE 187C>G variant, and lower hsCRP predicted delayed onset of neuropathy among self-reported white individuals initating cART. These findings require confirmation but may have implications for cART in HIV+ populations in areas with high endemic iron deficiency, especially those PWH in whom older, more neurotoxic antiretroviral drugs are occasionally still used.",2020,Carriers of HFE variants had higher systemic iron (lower sTFR and sTFR-ferritin index) and lower hsCRP levels than non-carriers (all p<0.05).,"['151 eligible participants with stored serum who were included in the original genetic study', 'People with HIV (PWH']",[],"['Higher sTFR or iron stores', 'systemic iron (lower sTFR and sTFR-ferritin index) and lower hsCRP levels', 'sTFR-ferritin index of iron stores, and high-sensitivity C-reactive protein (hsCRP) levels']","[{'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble'}, {'cui': 'C0450235', 'cui_str': 'Evaluation of iron stores'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",151.0,0.107466,Carriers of HFE variants had higher systemic iron (lower sTFR and sTFR-ferritin index) and lower hsCRP levels than non-carriers (all p<0.05).,"[{'ForeName': 'Asha R', 'Initials': 'AR', 'LastName': 'Kallianpur', 'Affiliation': 'Genomic Medicine Institute, Cleveland Clinic/Lerner Research Institute, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Wanqing', 'Initials': 'W', 'LastName': 'Wen', 'Affiliation': 'Division of Epidemiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Angelika L', 'Initials': 'AL', 'LastName': 'Erwin', 'Affiliation': 'Genomic Medicine Institute, Cleveland Clinic/Lerner Research Institute, Cleveland, Ohio, United States of America.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Clifford', 'Affiliation': 'Division of Infectious Diseases, Departments of Medicine and Neurology, Washington University School of Medicine, Saint Louis, Missouri, United States of America.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Hulgan', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Robbins', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}]",PloS one,['10.1371/journal.pone.0239758']
2693,33057642,Association of Prehospital Plasma With Survival in Patients With Traumatic Brain Injury: A Secondary Analysis of the PAMPer Cluster Randomized Clinical Trial.,"Importance


Prehospital plasma administration improves survival in injured patients at risk for hemorrhagic shock and transported by air ambulance. Traumatic brain injury (TBI) is a leading cause of death following trauma, but few early interventions improve outcomes.
Objective


To assess the association between prehospital plasma and survival in patients with TBI.
Design, Setting, and Participants


The Prehospital Air Medical Plasma (PAMPer) trial was a pragmatic, multicenter, phase 3, cluster randomized clinical trial involving injured patients who were at risk for hemorrhagic shock during air medical transport to a trauma center. The trial was conducted at 6 US sites with 9 level-I trauma centers (comprising 27 helicopter emergency services bases). The original trial analyzed 501 patients, including 230 patients who were randomized to receive plasma and 271 randomized to standard care resuscitation. This secondary analysis of a predefined subgroup included patients with TBI. Data analysis was performed from October 2019 to February 2020.
Interventions


Patients were randomized to receive standard care fluid resuscitation or 2 units of thawed plasma.
Main Outcomes and Measures


The primary outcome was mortality at 30 days. Patients with TBI were prespecified as a subgroup for secondary analysis and for measurement of markers of brain injury. The 30-day survival benefit of prehospital plasma in subgroups with and without TBI as diagnosed by computed tomography was characterized using Kaplan-Meier survival analysis and Cox proportional hazard regression.
Results


In total, 166 patients had TBI (median [interquartile range] age, 43.00 [25.00-59.75] years; 125 men [75.3%]). When compared with the 92 patients who received standard care, the 74 patients with TBI who received prehospital plasma had improved 30-day survival even after adjustment for multiple confounders and assessment of the degree of brain injury with clinical variables and biomarkers (hazard ratio [HR], 0.55; 95% CI, 0.33-0.94; P = .03). Receipt of prehospital plasma was associated with improved survival among patients with TBI with a prehospital Glasgow Coma Scale score of less than 8 (HR, 0.56; 95% CI, 0.35-0.91) and those with polytrauma (HR, 0.50; 95% CI, 0.28-0.89). Patients with TBI transported from the scene of injury had improved survival following prehospital plasma administration (HR, 0.45; 95% CI, 0.26-0.80; P = .005), whereas patients who were transferred from an outside hospital showed no difference in survival for the plasma intervention (HR, 1.00; 95% CI, 0.33-3.00; P = .99).
Conclusions and Relevance


These findings are exploratory, but they suggest that receipt of prehospital plasma is associated with improved survival in patients with computed tomography-positive TBI. The prehospital setting may be a critical period to intervene in the care of patients with TBI. Future studies are needed to confirm the clinical benefits of early plasma resuscitation following TBI and concomitant polytrauma.
Trial Registration


ClinicalTrials.gov Identifier: NCT01818427.",2020,"Patients with TBI transported from the scene of injury had improved survival following prehospital plasma administration (HR, 0.45; 95% CI, 0.26-0.80; P = .005), whereas patients who were transferred from an outside hospital showed no difference in survival for the plasma intervention (HR, 1.00; 95% CI, 0.33-3.00; P = .99).
","['patients with TBI', 'injured patients who were at risk for hemorrhagic shock during air medical transport to a trauma center', 'injured patients at risk for hemorrhagic shock and transported by air ambulance', 'Patients With Traumatic Brain Injury', '501 patients, including 230 patients who were randomized to receive plasma and 271 randomized to standard care resuscitation', '6 US sites with 9 level-I trauma centers (comprising 27 helicopter emergency services bases', '25.00-59.75] years; 125 men [75.3', 'patients with computed tomography-positive TBI', '166 patients had TBI (median [interquartile range] age, 43.00', 'Traumatic brain injury (TBI']",['standard care fluid resuscitation or 2 units of thawed plasma'],"['prehospital Glasgow Coma Scale score', 'mortality at 30 days', '30-day survival benefit of prehospital plasma', '30-day survival', 'survival following prehospital plasma administration', 'prehospital plasma and survival', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0036982', 'cui_str': 'Hemorrhagic shock'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0206185', 'cui_str': 'Air transport ambulance'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0206183', 'cui_str': 'Emergency Helicopters'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",501.0,0.386256,"Patients with TBI transported from the scene of injury had improved survival following prehospital plasma administration (HR, 0.45; 95% CI, 0.26-0.80; P = .005), whereas patients who were transferred from an outside hospital showed no difference in survival for the plasma intervention (HR, 1.00; 95% CI, 0.33-3.00; P = .99).
","[{'ForeName': 'Danielle S', 'Initials': 'DS', 'LastName': 'Gruen', 'Affiliation': 'Department of Surgery and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'Department of Surgery and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Okonkwo', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Ava M', 'Initials': 'AM', 'LastName': 'Puccio', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Insiyah K', 'Initials': 'IK', 'LastName': 'Campwala', 'Affiliation': 'Department of Surgery and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Tessmer', 'Affiliation': 'Department of Surgery and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Daley', 'Affiliation': 'Department of Surgery, University of Tennessee Health Science Center, Knoxville.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Miller', 'Affiliation': 'Department of Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Harbrecht', 'Affiliation': 'Department of Surgery, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Claridge', 'Affiliation': 'MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Herb A', 'Initials': 'HA', 'LastName': 'Phelan', 'Affiliation': 'Department of Surgery, University of Texas Southwestern, Dallas.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': 'Department of Surgery and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Zuckerbraun', 'Affiliation': 'Department of Surgery and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Yazer', 'Affiliation': 'Department of Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Billiar', 'Affiliation': 'Department of Surgery and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'Department of Surgery and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.16869']
2694,33057643,Virtual Standardized Patients vs Academic Training for Learning Motivational Interviewing Skills in the US Department of Veterans Affairs and the US Military: A Randomized Trial.,"Importance


Despite the need for effective and scalable training in motivational interviewing (MI) that includes posttraining coaching and feedback, limited evidence exists regarding the effectiveness of using virtual (computerized) standardized patients (VSPs) in such training.
Objective


To evaluate the efficacy of training with a VSP on the acquisition and maintenance of MI skills compared with traditional academic study.
Design, Setting, and Participants


This study was a 2-group, parallel-training randomized trial of 120 volunteer health care professionals recruited from a Department of Veterans Affairs and Department of Defense medical facility. Motivational interviewing skill was coded by external experts blinded to training group and skill assessment time points. Data were collected from October 17, 2016, to August 12, 2019.
Interventions


After a computer course on MI, participants trained during two 45-minute sessions separated by 3 months. The 2 randomized training conditions included a branching storyline VSP, which provided MI skill rehearsal with immediate and summative feedback, and a control condition, which included academic study of content from the computerized MI course.
Main Outcomes and Measures


Measurement of MI skill was based on recorded conversations with human standardized patients, assessed using the Motivational Interviewing Treatment Integrity 4.2.1 coding system, measured at baseline, after training, and after additional training in the randomized condition 3 months later.
Results


A total of 120 volunteers (83 [69%] women), with a mean (SD) of 13.6 (10.3) years of health care experience, participated in the study; 61 were randomized to receive the intervention, and 59 were randomized to the control group. Those assigned to VSP training had significantly greater posttraining improvement in technical global scores (0.23; 95% CI, 0.03-0.44; P = .02), relational global scores (0.57; 95% CI, 0.33-0.81; P = .001), and the reflection-to-question ratio (0.23; 95% CI, 0.15-0.31; P = .001). Differences were maintained after the 3-month additional training session, with more improvements achieved after the 3-month training for the VSP trainees on the reflection-to- question ratio (0.15; 95% CI, 0.07-0.24; P = .001).
Conclusions and Relevance


This randomized trial demonstrated a successful transfer of training from a VSP to human standardized patients. The VSP MI skill outcomes were better than those achieved with academic study and were maintained over time. Virtual standardized patients have the potential to facilitate dissemination of MI and may be useful for training in other evidence-based skills and treatments.
Trial Registration


ClinicalTrials.gov Identifier: NCT04558060.",2020,"Those assigned to VSP training had significantly greater posttraining improvement in technical global scores (0.23; 95% CI, 0.03-0.44; P = .02), relational global scores (0.57; 95% CI, 0.33-0.81; P = .001), and the reflection-to-question ratio (0.23; 95% CI, 0.15-0.31; P = .001).","['120 volunteer health care professionals recruited from a Department of Veterans Affairs and Department of Defense medical facility', 'Data were collected from October 17, 2016, to August 12, 2019', '120 volunteers (83 [69%] women), with a mean (SD) of 13.6 (10.3) years of health care experience, participated in the study; 61', 'Veterans Affairs and the US Military', 'human standardized patients']","['VSP', 'VSP training', 'Virtual Standardized Patients vs Academic Training', 'branching storyline VSP, which provided MI skill rehearsal with immediate and summative feedback, and a control condition']","['Measures\n\n\nMeasurement of MI skill', 'relational global scores', 'reflection-to-question ratio', 'technical global scores', 'VSP MI skill outcomes', 'reflection-to- question ratio']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000875', 'cui_str': 'Academic Training'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",120.0,0.0642577,"Those assigned to VSP training had significantly greater posttraining improvement in technical global scores (0.23; 95% CI, 0.03-0.44; P = .02), relational global scores (0.57; 95% CI, 0.33-0.81; P = .001), and the reflection-to-question ratio (0.23; 95% CI, 0.15-0.31; P = .001).","[{'ForeName': 'Greg M', 'Initials': 'GM', 'LastName': 'Reger', 'Affiliation': 'Veterans Affairs (VA) Puget Sound Healthcare System, Seattle and Tacoma, Washington.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Norr', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Albert Skip', 'Initials': 'AS', 'LastName': 'Rizzo', 'Affiliation': 'Institute for Creative Technologies, University of Southern California, Marina del Rey.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Sylvers', 'Affiliation': 'Veterans Affairs (VA) Puget Sound Healthcare System, Seattle and Tacoma, Washington.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Peltan', 'Affiliation': 'Veterans Affairs (VA) Puget Sound Healthcare System, Seattle and Tacoma, Washington.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fischer', 'Affiliation': 'Veterans Affairs (VA) Puget Sound Healthcare System, Seattle and Tacoma, Washington.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Trimmer', 'Affiliation': 'Institute for Creative Technologies, University of Southern California, Marina del Rey.'}, {'ForeName': 'Shelan', 'Initials': 'S', 'LastName': 'Porter', 'Affiliation': 'Veterans Affairs (VA) Puget Sound Healthcare System, Seattle and Tacoma, Washington.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Gant', 'Affiliation': 'Veterans Affairs (VA) Puget Sound Healthcare System, Seattle and Tacoma, Washington.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Baer', 'Affiliation': 'Veterans Affairs (VA) Puget Sound Healthcare System, Seattle and Tacoma, Washington.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.17348']
2695,33057807,Romosozumab followed by denosumab in Japanese women with high fracture risk in the FRAME trial.,"INTRODUCTION


This post-hoc analysis of the FRAME study investigated the long-term efficacy and safety of romosozumab followed by denosumab in postmenopausal Japanese women with osteoporosis at high fracture risk.
MATERIALS AND METHODS


Data from Japanese women with a high fracture risk participating in the international, randomised, double-blind, placebo-controlled, phase 3 FRAME study were analysed. High risk of fracture was defined as ≥ 1 fragility fracture with bone mineral density (BMD) ≤ - 2.5 standard deviations [SD], > 2 prevalent vertebral fractures, prevalent semiquantitative grade 3 vertebral fracture, or lumbar spine BMD < - 3.3 SD. Endpoints included incidence of new vertebral fracture at 12, 24 and 36 months and percentage change from baseline in BMD at the lumbar spine, total hip and femoral neck.
RESULTS


187 Japanese subjects at high risk of fracture were enrolled in FRAME. Incidence of new vertebral fractures was lower with romosozumab/denosumab vs. placebo/denosumab at 12, 24 and 36 months (relative risk reduction at all timepoints: 84%; p = 0.056). BMD increases at 12, 24 and 36 months were greater in subjects receiving romosozumab/denosumab than placebo/denosumab (lumbar spine: 16.3%, 21.5% and 23.2% vs 0.4%, 8.1% and 10.4%; total hip: 4.9%, 7.9% and 8.9% vs 0.4%, 2.8% and 4.1%; femoral neck: 4.8%, 7.6% and 8.1% vs 0.3%, 3.3% and 3.7%, respectively; all p < 0.001 vs placebo/denosumab). Adverse events were generally balanced between groups.
CONCLUSION


Romosozumab/denosumab in Japanese subjects at high risk of fracture resulted in significant BMD gains and numerically lower vertebral fracture rate vs. placebo/denosumab at all timepoints measured.",2020,"BMD increases at 12, 24 and 36 months were greater in subjects receiving romosozumab/denosumab than placebo/denosumab (lumbar spine: 16.3%, 21.5% and 23.2% vs 0.4%, 8.1% and 10.4%; total hip: 4.9%, 7.9% and 8.9% vs 0.4%, 2.8% and 4.1%; femoral neck: 4.8%, 7.6% and 8.1% vs 0.3%, 3.3% and 3.7%, respectively; all p < 0.001 vs placebo/denosumab).","['1 fragility fracture with bone mineral density (BMD)\u2009≤\u2009-\u20092.5 standard deviations [SD],\u2009>\u20092 prevalent vertebral fractures, prevalent semiquantitative grade 3 vertebral fracture, or lumbar spine BMD', 'Japanese subjects', '187 Japanese subjects at high risk of fracture were enrolled in FRAME', 'Data from Japanese women with a high fracture risk participating in the international', 'Japanese women with high fracture risk in the FRAME trial', 'postmenopausal Japanese women with osteoporosis at high fracture risk']","['Romosozumab followed by denosumab', 'romosozumab', 'romosozumab/denosumab vs. placebo/denosumab', 'placebo/denosumab', 'placebo', 'Romosozumab/denosumab', 'denosumab']","['BMD at the lumbar spine, total hip and femoral neck', 'BMD gains', 'Adverse events', 'vertebral fracture rate', 'Incidence of new vertebral fractures', 'incidence of new vertebral fracture', 'BMD']","[{'cui': 'C4760971', 'cui_str': 'Fragility fracture'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C3661283', 'cui_str': 'romosozumab'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}]",187.0,0.185119,"BMD increases at 12, 24 and 36 months were greater in subjects receiving romosozumab/denosumab than placebo/denosumab (lumbar spine: 16.3%, 21.5% and 23.2% vs 0.4%, 8.1% and 10.4%; total hip: 4.9%, 7.9% and 8.9% vs 0.4%, 2.8% and 4.1%; femoral neck: 4.8%, 7.6% and 8.1% vs 0.3%, 3.3% and 3.7%, respectively; all p < 0.001 vs placebo/denosumab).","[{'ForeName': 'Akimitsu', 'Initials': 'A', 'LastName': 'Miyauchi', 'Affiliation': 'Miyauchi Medical Center, Osaka, Japan.'}, {'ForeName': 'Etsuro', 'Initials': 'E', 'LastName': 'Hamaya', 'Affiliation': 'Amgen K.K., Midtown Tower 9-7-1 Akasaka Minato-ku, Tokyo, 107-6239, Japan. ehamaya@amgen.com.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Nishi', 'Affiliation': 'Amgen K.K., Midtown Tower 9-7-1 Akasaka Minato-ku, Tokyo, 107-6239, Japan.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Libanati', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Cae', 'Initials': 'C', 'LastName': 'Tolman', 'Affiliation': 'Amgen Asia, Hong Kong, SAR, China.'}, {'ForeName': 'Junichiro', 'Initials': 'J', 'LastName': 'Shimauchi', 'Affiliation': 'Amgen K.K., Midtown Tower 9-7-1 Akasaka Minato-ku, Tokyo, 107-6239, Japan.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-020-01147-5']
2696,33057823,Disinfection with single or double usage of new antiseptic olanexidine gluconate in general surgery: a randomized study.,"PURPOSE


Olanexidine gluconate is a newly developed solution for skin disinfection that was recently approved in Japan. We aimed to compare single and double application of the solution in preventing surgical site infection (SSI) in patients undergoing general surgery.
METHODS


This randomized study was conducted at the Tottori University Hospital. Patients scheduled to undergo gastrointestinal or hernia surgery were randomly assigned to one of two groups using either one or two Olanedine applicators for skin disinfection. The primary endpoint was the difference in SSI incidence between the two groups. The secondary endpoint was all adverse events related to olanexidine gluconate.
RESULTS


A total of 393 patients qualified for the study protocol: 193 received a single application, and 200 received a double application of Olanedine. SSI occurred in 10 patients (2.5%) overall; nine were superficial incisional SSIs, and one patient had a deep incisional SSI. Of the 10 patients who developed SSI, six (3.1%) were in the group receiving a single application, and four (2.0%) were in the group receiving a double application; there was no statistically significant difference between the two groups (P = 0.537). Allergic reactions or skin disorders related to olanexidine gluconate were not observed.
CONCLUSION


There was no difference in the SSI incidence between the use of one or two Olanedine applicators for skin preparation in elective general surgery. Therefore, a single application of Olanedine is sufficient and is recommended for general surgery as a standard disinfection precaution.
TRIAL REGISTRATION NUMBER


UMIN000027319; 5/12/2017.",2020,There was no difference in the SSI incidence between the use of one or two Olanedine applicators for skin preparation in elective general surgery.,"['Patients scheduled to undergo gastrointestinal or hernia surgery', 'general surgery', 'Tottori University Hospital', 'patients undergoing general surgery', '393 patients qualified for the study protocol: 193 received a single application, and 200 received a']","['Olanexidine gluconate', 'Olanedine', 'olanexidine gluconate', 'Disinfection with single or double usage of new antiseptic olanexidine gluconate', 'Olanedine applicators for skin disinfection', 'double application of Olanedine']","['surgical site infection (SSI', 'SSI incidence', 'deep incisional SSI', 'SSI', 'Allergic reactions or skin disorders', 'superficial incisional SSIs']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C4507560', 'cui_str': 'olanexidine gluconate'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0179108', 'cui_str': 'Applicator'}, {'cui': 'C1698034', 'cui_str': 'Skin disinfection'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3662302', 'cui_str': 'Deep incisional surgical site infection'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0184898', 'cui_str': 'Incision'}]",393.0,0.149504,There was no difference in the SSI incidence between the use of one or two Olanedine applicators for skin preparation in elective general surgery.,"[{'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Tottori University Faculty of Medicine, 36-1 Nishi-cho, Yonago, 683-8504, Japan. m.yamamoto@tottori-u.ac.jp.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Hara', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Tottori University Faculty of Medicine, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Sugezawa', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Tottori University Faculty of Medicine, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Uejima', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Tottori University Faculty of Medicine, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Akimitsu', 'Initials': 'A', 'LastName': 'Tanio', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Tottori University Faculty of Medicine, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Yoichiro', 'Initials': 'Y', 'LastName': 'Tada', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Tottori University Faculty of Medicine, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Shishido', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Tottori University Faculty of Medicine, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Kozo', 'Initials': 'K', 'LastName': 'Miyatani', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Tottori University Faculty of Medicine, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Takehiko', 'Initials': 'T', 'LastName': 'Hanaki', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Tottori University Faculty of Medicine, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Kyoichi', 'Initials': 'K', 'LastName': 'Kihara', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Tottori University Faculty of Medicine, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Matsunaga', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Tottori University Faculty of Medicine, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Naruo', 'Initials': 'N', 'LastName': 'Tokuyasu', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Tottori University Faculty of Medicine, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Takano', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Tottori University Faculty of Medicine, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Teruhisa', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Tottori University Faculty of Medicine, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Honjo', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Tottori University Faculty of Medicine, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Tottori University Faculty of Medicine, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}]",Langenbeck's archives of surgery,['10.1007/s00423-020-02007-6']
2697,33057829,"Aesthetic Comparison of Abdominal Donor Site Scar Between Absorbable Dermal Staple and Subcutaneous Suture after Autologous Breast Reconstruction: A Prospective Randomized Controlled, Double-Blinded Study.","BACKGROUND


Abdominal tissue transfer has become the most commonly used tool for breast reconstruction. However, a secondary operator is often responsible for donor closure, which leaves dissatisfaction to patients due to inconsistent donor scars. Now, an absorbable dermal stapler is popularized worldwide and currently used for wound closure in many surgical fields. In this study, we aim to evaluate the abdominal donor site scar in using an absorbable dermal staple compared to a conventional suture.
METHODS


This is a prospective, randomized controlled and double-blinded study. Between January 2018 and April 2019, a total of 30 patients who underwent breast reconstruction using abdominal flap were included. Donor sites were divided into equal halves, and the each dermal layer was sutured with either dermal staples or traditional suturing, respectively. At 1, 3 and 6 months after operation, the scar was evaluated by two blinded plastic surgeons by using the modified Manchester scar scale (MSS).
RESULTS


An averaged sum of modified MSS was lower for the side sutured with a dermal stapler at the first month (11.76 ± 2.12 vs. 12.28 ± 2.03, p = 0.097), third month (12.17 ± 1.86 vs. 12.62 ± 2.31, p = 0.301) and sixth month (11.28 ± 2.63 vs. 12.14 ± 2.76, p = 0.051). Also, the dermal stapler side scored significantly higher for patient satisfaction than did the suture side (4.03 ± 0.98 vs 3.66 ± 0.97, p < 0.05).
CONCLUSION


The objective outcome of the scar closed by an absorbable dermal stapler was not statistically superior to conventional suturing. (p > 0.05) In the subjective outcome, however, it showed a significantly higher patients' satisfaction (p < 0.05).
LEVEL OF EVIDENCE III


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2020,"In the subjective outcome, however, it showed a significantly higher patients' satisfaction (p < 0.05).
","['Between January 2018 and April 2019, a total of 30 patients who underwent breast reconstruction using abdominal flap were included', 'after Autologous Breast Reconstruction']","['absorbable dermal staple', 'absorbable dermal stapler', 'Abdominal Donor Site Scar', 'Absorbable Dermal Staple and Subcutaneous Suture', 'conventional suture']","['modified MSS', ""patients' satisfaction"", 'modified Manchester scar scale (MSS', 'patient satisfaction']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0440910', 'cui_str': 'Abdominal flap'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}]","[{'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",30.0,0.0593795,"In the subjective outcome, however, it showed a significantly higher patients' satisfaction (p < 0.05).
","[{'ForeName': 'Jae-Ho', 'Initials': 'JH', 'LastName': 'Chung', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Korea University Anam Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyung-Kyu', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Korea University Ansan Hospital, 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15355, Republic of Korea.'}, {'ForeName': 'Yun-Hwan', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Korea University Ansan Hospital, 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15355, Republic of Korea.'}, {'ForeName': 'Hyung-Chul', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Korea University Anam Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hi-Jin', 'Initials': 'HJ', 'LastName': 'You', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Korea University Ansan Hospital, 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15355, Republic of Korea.'}, {'ForeName': 'Deok-Woo', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Korea University Ansan Hospital, 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15355, Republic of Korea. deokwookim@gmail.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01969-8']
2698,33057858,"The Effect of the Low FODMAP Diet on Gastrointestinal Symptoms, Behavioral Problems and Nutrient Intake in Children with Autism Spectrum Disorder: A Randomized Controlled Pilot Trial.","Some research suggests that GI symptoms seen in children with ASD may relate to behavior problems. The objective of this pilot study was to assess the effect of the low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet on GI and behavioral problems in children with ASD. At follow-up, the low FODMAP diet group had significant relief in some GI problems compared with both baseline in the group and control group. At baseline and at follow-up, there were no significant differences in behavioral problems between the low FODMAP diet group and the control group. Randomized controlled studies including larger sample sizes are needed to confirm the effects of low FODMAP diets in children with autism who have gastrointestinal problems.",2020,"At baseline and at follow-up, there were no significant differences in behavioral problems between the low FODMAP diet group and the control group.","['Children with Autism', 'Spectrum Disorder', 'children with ASD', 'children with autism who have gastrointestinal problems']","['Low FODMAP Diet', 'low FODMAP diets', 'low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet']","['Gastrointestinal Symptoms, Behavioral Problems and Nutrient Intake', 'GI problems', 'behavioral problems']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0017187', 'cui_str': 'Gastrointestinal tract problem'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0012611', 'cui_str': 'Disaccharide'}, {'cui': 'C0026492', 'cui_str': 'Monosaccharide'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0017187', 'cui_str': 'Gastrointestinal tract problem'}]",,0.0678772,"At baseline and at follow-up, there were no significant differences in behavioral problems between the low FODMAP diet group and the control group.","[{'ForeName': 'Nalan Hakime', 'Initials': 'NH', 'LastName': 'Nogay', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Health Sciences, Erciyes University, Kayseri, Turkey. nalanhakime@gmail.com.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Walton', 'Affiliation': ""Developmental and Behavioral Pediatrics, Nationwide Children's Hospital, Ohio State University College of Medicine, Columbus, OH, USA.""}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Roberts', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, School of Health and Rehabilitation Sciences, College of Medicine, The Ohio State University, 453 West 10th Avenue, Columbus, OH, 43210, USA.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Nahikian-Nelms', 'Affiliation': 'School of Health and Rehabilitation Sciences, College of Medicine, The Ohio State University, 453 West 10th Avenue, Columbus, OH, 43210, USA.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Witwer', 'Affiliation': 'Department of Psychology and Psychiatry, Nisonger Center, The Ohio State University, 371C McCampbell Hall, 1581 Dodd Drive, Columbus, OH, 43210, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04717-8']
2699,33062915,The effect of low-dose aspirin on the pregnancy rate in frozen-thawed embryo transfer cycles: A randomized clinical trial.,"Background


The results of previous studies on the effect of low-dose aspirin in frozen-thawed embryo transfer (FET) cycles are limited and controversial.
Objective


To evaluate the effect of low-dose aspirin on the clinical pregnancy in the FET cycles.
Materials and Methods


This study was performed as a randomized clinical trial from May 2018 to February 2019; 128 women who were candidates for the FET were randomly assigned to two groups receiving either 80 mg oral aspirin (n = 64) or no treatment. The primary outcome was clinical pregnancy rate and secondary outcome measures were the implantation rate, miscarriage rate, and endometrial thickness.
Results


The endometrial thickness was lower in patients who received aspirin in comparison to the control group. There were statistically significant differences between the two groups (p = 0.018). Chemical and clinical pregnancy rates and abortion rate was similar in the two groups and there was no statistically significant difference.
Conclusion


The administration of aspirin in FET cycles had no positive effect on the implantation and the chemical and clinical pregnancy rates, which is in accordance with current Cochrane review that does not recommend aspirin administration as a routine in assisted reproductive technology cycles.",2020,"The administration of aspirin in FET cycles had no positive effect on the implantation and the chemical and clinical pregnancy rates, which is in accordance with current Cochrane review that does not recommend aspirin administration as a routine in assisted reproductive technology cycles.","['May 2018 to February 2019; 128 women who were candidates for the FET', 'frozen-thawed embryo transfer cycles']","['80 mg oral aspirin', 'low-dose aspirin', 'aspirin']","['Chemical and clinical pregnancy rates and abortion rate', 'clinical pregnancy rate', 'endometrial thickness', 'implantation rate, miscarriage rate, and endometrial thickness', 'pregnancy rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0000794', 'cui_str': 'Abortion Rate'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",,0.256188,"The administration of aspirin in FET cycles had no positive effect on the implantation and the chemical and clinical pregnancy rates, which is in accordance with current Cochrane review that does not recommend aspirin administration as a routine in assisted reproductive technology cycles.","[{'ForeName': 'Robab', 'Initials': 'R', 'LastName': 'Davar', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Pourmasumi', 'Affiliation': 'Non-Communicable Diseases Research Center, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Banafsheh', 'Initials': 'B', 'LastName': 'Mohammadi', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Maryam Mortazavi', 'Initials': 'MM', 'LastName': 'Lahijani', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",International journal of reproductive biomedicine,['10.18502/ijrm.v13i9.7664']
2700,33062918,Effect of embryo transfer depth on IVF/ICSI outcomes: A randomized clinical trial.,"Background


Although there has been remarkable advancement in the field of assisted reproductive technology, implantation failure remains a significant issue in most infertile couples receiving these treatments. Embryo transfer is important in assisted reproductive technology and directly affects the implantation rates and pregnancy outcomes.
Objective


To assess the effect of two different distance embryo transfer sites from fundal endometrial surface on the outcomes of in-vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) cycles.
Materials and Methods


A total of 180 women who were candidate for IVF/ ICSI/ embryo transfer in Yazd Research and Clinical Center for Infertility were equally assigned to two groups based on the distance between the fundal endometrial surface and catheter tip to investigate implantation, chemical and clinical pregnancy (group A: 15  ±  5 mm and group B: 25  ±  5 mm, respectively).
Results


The subjects in the group B showed significantly higher implantation rate, chemical and clinical pregnancy rate compared to the group A (p = 0.03, 0.01, 0.04, respectively). The rate of ongoing pregnancy and miscarriage indicated no significant differences between groups (p = 0.21, 0.27, respectively).
Conclusion


In conclusion, our study showed that the depth of embryo replacement inside the uterine cavity at a distance of 25  ±  5 mm beneath fundal endometrial surface have better effects on the pregnancy outcomes of IVF/ICSI cycles and can be considered as an important factor to improve the success of IVF cycles.",2020,"The rate of ongoing pregnancy and miscarriage indicated no significant differences between groups (p = 0.21, 0.27, respectively).
","['infertile couples receiving these treatments', '180 women who were candidate for IVF/ ICSI/ embryo transfer in Yazd Research and Clinical Center for Infertility']","['fundal endometrial surface and catheter tip to investigate implantation, chemical and clinical pregnancy', 'embryo transfer depth']","['IVF/ICSI outcomes', 'implantation rate, chemical and clinical pregnancy rate', 'vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) cycles', 'rate of ongoing pregnancy and miscarriage']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0444299', 'cui_str': 'Catheter tip'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]","[{'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",180.0,0.205851,"The rate of ongoing pregnancy and miscarriage indicated no significant differences between groups (p = 0.21, 0.27, respectively).
","[{'ForeName': 'Robab', 'Initials': 'R', 'LastName': 'Davar', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Seyedeh Mahsa', 'Initials': 'SM', 'LastName': 'Poormoosavi', 'Affiliation': 'Department of Histology, School of Medicine, Dezful University of Medical Sciences, Dezful, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Mohseni', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Janati', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Dezful University of Medical Sciences, Dezful, Iran.'}]",International journal of reproductive biomedicine,['10.18502/ijrm.v13i9.7667']
2701,33063203,Association Between Statins and Cancer Incidence in Diabetes: a Cohort Study of Japanese Patients with Type 2 Diabetes.,"BACKGROUND


The antitumor effect of statins has been highlighted, but clinical study results remain inconclusive. While patients with diabetes are at high risk of cancer, it is uncertain whether statins are effective for cancer chemoprevention in this population.
OBJECTIVE


This study evaluated the association between statins and cancer incidence/mortality in patients with type 2 diabetes.
DESIGN


This study was a follow-up observational study of the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD) trial, which was a randomized controlled trial of low-dose aspirin in Japanese patients with type 2 diabetes.
PARTICIPANTS


This study enrolled 2536 patients with type 2 diabetes, age 30-85 years, and no history of atherosclerotic cardiovascular disease, from December 2002 until May 2005. All participants recruited in the JPAD trial were followed until the day of any fatal event or July 2015. We defined participants taking any statin at enrollment as the statin group (n = 650) and the remainder as the no-statin group (n = 1886).
MAIN MEASURES


The primary end point was the first occurrence of any cancer (cancer incidence). The secondary end point was death from any cancer (cancer mortality).
KEY RESULTS


During follow-up (median, 10.7 years), 318 participants developed a new cancer and 123 died as a result. Cancer incidence and mortality were 10.5 and 3.7 per 1000 person-years in the statin group, and 16.8 and 6.3 per 1000 person-years in the no-statin group, respectively. Statin use was associated with significantly reduced cancer incidence and mortality after adjustment for confounding factors (cancer incidence: adjusted hazard ratio [HR], 0.67; 95% CI, 0.49-0.90, P = 0.007; cancer mortality: adjusted HR, 0.60; 95% CI, 0.36-0.98, P = 0.04).
CONCLUSIONS


Statin use was associated with a reduced incidence and mortality of cancer in Japanese patients with type 2 diabetes.",2020,"Statin use was associated with significantly reduced cancer incidence and mortality after adjustment for confounding factors (cancer incidence: adjusted hazard ratio [HR], 0.67; 95% CI, 0.49-0.90, P = 0.007; cancer mortality: adjusted HR, 0.60; 95% CI, 0.36-0.98, P = 0.04).
","['participants taking any statin at enrollment as the statin group (n\u2009=\u2009650) and the remainder as the no-statin group (n\u2009=\u20091886', 'Diabetes', 'patients with type 2 diabetes', 'Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD', 'Japanese patients with type 2 diabetes', '2536 patients with type 2 diabetes, age 30-85\xa0years, and no history of atherosclerotic cardiovascular disease, from December 2002 until May 2005', 'All participants recruited in the JPAD trial were followed until the day of any fatal event or July 2015', '318 participants developed a new cancer and 123 died as a result', 'Japanese Patients with Type 2 Diabetes']",['aspirin'],"['death from any cancer (cancer mortality', 'cancer incidence and mortality', 'Cancer incidence and mortality', 'incidence and mortality of cancer', 'first occurrence of any cancer (cancer incidence']","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",2536.0,0.052467,"Statin use was associated with significantly reduced cancer incidence and mortality after adjustment for confounding factors (cancer incidence: adjusted hazard ratio [HR], 0.67; 95% CI, 0.49-0.90, P = 0.007; cancer mortality: adjusted HR, 0.60; 95% CI, 0.36-0.98, P = 0.04).
","[{'ForeName': 'Sadanori', 'Initials': 'S', 'LastName': 'Okada', 'Affiliation': 'Center for Postgraduate Training, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': 'National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Soejima', 'Affiliation': 'Department of Cardiology, Graduate School of Medical Science, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Chisa', 'Initials': 'C', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiology, Center for Health Surveillance & Preventive Medicine, Tokyo Medical University Hospital, Tokyo, Japan.'}, {'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Sakuma', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': 'Nakayama Cardiovascular Clinic, Kumamoto, Japan.'}, {'ForeName': 'Naofumi', 'Initials': 'N', 'LastName': 'Doi', 'Affiliation': 'Department of Cardiovascular Medicine, Nara Prefectural Seiwa Medical Center, Nara, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Jinnouchi', 'Affiliation': 'Department of Internal Medicine, Jinnouchi Hospital Diabetes Care Center, Kumamoto, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Waki', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Metabolism, Shizuoka City Shizuoka Hospital, Shizuoka, Japan.'}, {'ForeName': 'Izuru', 'Initials': 'I', 'LastName': 'Masuda', 'Affiliation': 'Medical Examination Center, Takeda Hospital, Kyoto, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiovascular Medicine, Nara Medical University, 840 Shijo, Kashihara, Nara, 634-8522, Japan. saitonaramed@gmail.com.'}]",Journal of general internal medicine,['10.1007/s11606-020-06167-5']
2702,33063219,Contour changes of peri-implant tissues are minimal and similar for a one- and a two-piece implant system over 12 years.,"OBJECTIVES


To assess contour changes of peri-implant tissues comparing a one- and a two-piece dental implant system over 12 years.
MATERIALS AND METHODS


Patients seeking implant therapy were enrolled and randomly allocated to receive implants (a one-piece (STM) or a two-piece (BRA) system). Impressions were taken at the time of insertion of the final reconstruction (BL), after 1 year (FU-1), 5 years (FU-5), and at 12 years (FU-12). Thirty patients were included in the analysis (STM, 16; BRA, 14). Digital scans of casts were superimposed and analyzed in an image analysis program. Measurements included changes of the crown height, contour changes on the buccal side of the implants and the contralateral teeth (control).
RESULTS


Contour changes at implant sites revealed a loss of - 0.29 mm (STM) and - 0.46 mm (BRA) during an observation period of 12 years. Contour changes at the corresponding tooth sites amounted to - 0.06 mm (STM) and - 0.12 mm (BRA) during the same time period. The implant crown gained 0.25 mm (STM) and 0.08 mm (BRA) in height due to recession of the marginal mucosa. The corresponding gain in crown height at the contralateral tooth sites amounted to 0.36 mm (STM) and 0.10 mm (BRA). Interproximal marginal bone level changes measured - 0.28 mm (STM) and - 1.11 mm (BRA). The mean BOP amounted to 38.8% (STM) and 48.7% (BRA) at the 12-year follow-up (FU-12).
CONCLUSION


Minimal changes of the peri-implant soft tissue contour were observed at implant sites over the period of 12 years irrespective of the use of a one- or a two-piece implant system. The differences between the implant sites and corresponding teeth were clinically negligible.
CLINICAL RELEVANCE


Peri-implant soft tissue stability is of high clinical relevance when monitoring dental implant sites on the long run. Clinical data on the extent of soft tissue changes around different implant systems are scarce. The present RCTs demonstrate minimal changes of the peri-implant soft tissue contour 12 years after implant insertion independent of the use of a one- or a two-piece implant system.",2020,The present RCTs demonstrate minimal changes of the peri-implant soft tissue contour 12 years after implant insertion independent of the use of a one- or a two-piece implant system.,"['Thirty patients were included in the analysis (STM, 16; BRA, 14', 'Patients seeking implant therapy']",[],"['mean BOP', 'crown height, contour changes on the buccal side of the implants and the contralateral teeth (control', 'corresponding gain in crown height', 'Interproximal marginal bone level changes']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0079837', 'cui_str': 'Scanning Tunnelling Microscopy'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",30.0,0.030202,The present RCTs demonstrate minimal changes of the peri-implant soft tissue contour 12 years after implant insertion independent of the use of a one- or a two-piece implant system.,"[{'ForeName': 'Miha', 'Initials': 'M', 'LastName': 'Pirc', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, CH-8032, Zurich, Switzerland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Harbeck', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, CH-8032, Zurich, Switzerland.'}, {'ForeName': 'Vitor M', 'Initials': 'VM', 'LastName': 'Sapata', 'Affiliation': 'Discipline of Periodontics, School of Dentistry, University of São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Hüsler', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, CH-8032, Zurich, Switzerland.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Jung', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, CH-8032, Zurich, Switzerland.'}, {'ForeName': 'Christoph H F', 'Initials': 'CHF', 'LastName': 'Hämmerle', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, CH-8032, Zurich, Switzerland.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Thoma', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, CH-8032, Zurich, Switzerland. daniel.thoma@zzm.uzh.ch.'}]",Clinical oral investigations,['10.1007/s00784-020-03638-1']
2703,33063220,Comparison of indirect pulp treatment and iRoot BP Plus pulpotomy in primary teeth with extremely deep caries: a prospective randomized trial.,"OBJECTIVES


The purpose of this randomized controlled trial was to compare the 24-month success rates of indirect pulp treatment (IPT) and iRoot BP Plus pulpotomy of primary molars with extremely deep caries.
MATERIALS AND METHODS


Generally healthy children aged 3-7 years requiring general anesthesia for treating primary molars with extremely deep caries or reversible pulpitis were recruited. Patients with systemic disease, mental health problems, or manifestations of irreversible pulpitis were excluded. In total, 175 molars were randomized and blinded for either IPT (n = 87) or iRoot BP Plus pulpotomy (n = 88). All teeth were restored with stainless steel crowns and evaluated after 6, 12, 18, and 24 months by two blinded calibrated investigators. Kaplan-Meier survival curves were used to compare the survival rates between the groups. The correlations between success rate and patient characteristics were explored with the Cox proportional hazards model.
RESULTS


A total of 168 primary molars in 67 patients (average age: 3.83 years) were evaluated. The cumulative survival probability at 24 months was not significantly different between the IPT (93.8%) and pulpotomy (97.7%) groups (P = 0.238). IPT treatment success was significantly associated with age (odds ratio = 2.347; 95% CI: 1.068-5.156; P = 0.034) and preoperative sensitivity (odds ratio = 9.742; 95% CI: 1.079-87.970; P = 0.043).
CONCLUSIONS


The 24-month success rates of IPT and iRoot BP Plus pulpotomy performed in primary molars with extremely deep caries were not significantly different. Increasing age and preoperative sensitivity were found to be associated with the cumulative survival probability in IPT-treated primary molars with extremely deep caries. Primary teeth with extremely deep carious lesions without signs of irreversible pulpitis can be treated successfully by either indirect pulp capping or iRoot BP Plus pulpotomy.
TRIAL REGISTRATION


ChiCTR2000032462.",2020,The cumulative survival probability at 24 months was not significantly different between the IPT (93.8%) and pulpotomy (97.7%) groups (P = 0.238).,"['Primary teeth with extremely deep carious lesions without signs of irreversible pulpitis', 'Patients with systemic disease, mental health problems, or manifestations of irreversible pulpitis were excluded', 'In total, 175 molars', 'primary teeth with extremely deep caries', 'A total of 168 primary molars in 67 patients (average age: 3.83 years', 'Generally healthy children aged 3-7 years requiring general anesthesia for treating primary molars with extremely deep caries or reversible pulpitis were recruited', 'primary molars with extremely deep caries']","['indirect pulp treatment and iRoot BP', 'indirect pulp capping or iRoot BP Plus pulpotomy', 'IPT', 'iRoot BP Plus pulpotomy', 'Plus pulpotomy', 'indirect pulp treatment (IPT) and iRoot BP Plus pulpotomy']","['survival rates', 'Kaplan-Meier survival curves', 'preoperative sensitivity', 'cumulative survival probability', '24-month success rates of IPT and iRoot BP Plus pulpotomy', 'IPT treatment success']","[{'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442893', 'cui_str': 'Systemic disease'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0333523', 'cui_str': 'Deep caries'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}]","[{'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C1306815', 'cui_str': 'Pulp treatment'}, {'cui': 'C0011402', 'cui_str': 'Capping, Dental Pulp'}, {'cui': 'C4043153', 'cui_str': 'iRoot BP Plus'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C1306815', 'cui_str': 'Pulp treatment'}, {'cui': 'C4043153', 'cui_str': 'iRoot BP Plus'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",175.0,0.168662,The cumulative survival probability at 24 months was not significantly different between the IPT (93.8%) and pulpotomy (97.7%) groups (P = 0.238).,"[{'ForeName': 'Xiaoxian', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatric Dentistry, First Clinical Division, Peking University School and Hospital of Stomatology, Jia No.37 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatric Dentistry, First Clinical Division, Peking University School and Hospital of Stomatology, Jia No.37 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'Department of Pediatric Dentistry, First Clinical Division, Peking University School and Hospital of Stomatology, Jia No.37 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Department of Pediatric Dentistry, First Clinical Division, Peking University School and Hospital of Stomatology, Jia No.37 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Bichen', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'Department of Pediatric Dentistry, First Clinical Division, Peking University School and Hospital of Stomatology, Jia No.37 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Meili', 'Initials': 'M', 'LastName': 'Ding', 'Affiliation': 'Department of Pediatric Dentistry, First Clinical Division, Peking University School and Hospital of Stomatology, Jia No.37 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Shihua', 'Initials': 'S', 'LastName': 'Xue', 'Affiliation': 'Department of Pediatric Dentistry, First Clinical Division, Peking University School and Hospital of Stomatology, Jia No.37 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xia', 'Affiliation': 'Department of Pediatric Dentistry, Peking University School and Hospital of Stomatology, Zhongguancun South Avenue 22, Haidian District, Beijing, 100081, China. summerinbeijing@vip.sina.com.'}]",Clinical oral investigations,['10.1007/s00784-020-03627-4']
2704,33063249,Effect of Sacubitril/Valsartan on Neurocognitive Function: Current Status and Future Directions.,"Sacubitril/valsartan is a new medication approved for the treatment of heart failure with reduced ejection fraction. While the drug failed to meet the primary endpoint in patients with heart failure with preserved ejection fraction in the PARAGON-HF trial, improvements were noted in several secondary endpoints. Valsartan is an angiotensin receptor blocker and sacubitril is a neprilysin inhibitor. Neprilysin is postulated to have a role in the degradation of beta-amyloid in the brain; therefore, sacubitril could theoretically increase beta-amyloid plaque deposition in the brain and potentially increase the risk of Alzheimer's disease. Although pre-clinical and clinical studies have shown promising safety results, those studies have been heavily criticized for short monitoring time and targeted populations. In accordance with the requirements of the US Food and drug Administration (FDA), the ongoing Prospective Evaluation of Cognitive Function in Heart Failure: Efficacy and Safety of Entresto compared to Valsartan on Cognitive Function in Patients with Chronic Heart Failure and Preserved Ejection Fraction (PERSPECTIVE; NCT02884206) multicenter, randomized, double-blinded trial is assessing the long-term neurocognitive effects and safety of sacubitril/valsartan, and results are expected in early 2022.",2020,"While the drug failed to meet the primary endpoint in patients with heart failure with preserved ejection fraction in the PARAGON-HF trial, improvements were noted in several secondary endpoints.",['Patients with Chronic Heart Failure and Preserved Ejection Fraction'],"['Valsartan', 'Sacubitril/valsartan', 'Sacubitril/Valsartan', 'sacubitril/valsartan']","['Neurocognitive Function', 'Cognitive Function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0439181,"While the drug failed to meet the primary endpoint in patients with heart failure with preserved ejection fraction in the PARAGON-HF trial, improvements were noted in several secondary endpoints.","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Galo', 'Affiliation': 'Division of Internal Medicine, Department of Medicine, University of Miami/Jackson Memorial Hospital, 1611 NW 12th Ave, Central Building 600D, Miami, FL, 33136, USA. jason.galo@jhsmiami.org.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Celli', 'Affiliation': 'Division of Internal Medicine, Department of Medicine, University of Miami/Jackson Memorial Hospital, 1611 NW 12th Ave, Central Building 600D, Miami, FL, 33136, USA.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Colombo', 'Affiliation': 'Division of Cardiovascular Disease, Jackson Memorial Hospital, 1801 NW 9th Ave, Suite #209, Miami, FL, 33136, USA.'}]","American journal of cardiovascular drugs : drugs, devices, and other interventions",['10.1007/s40256-020-00445-7']
2705,33063270,Efficacy and Safety of Tofogliflozin and Ipragliflozin for Patients with Type-2 Diabetes: A Randomized Crossover Study by Flash Glucose Monitoring.,"INTRODUCTION


Sodium-glucose cotransporter 2 (SGLT2) inhibitors promote urinary glucose excretion. However, the differences in the effects of various SGLT2 inhibitors are unknown. We used flash glucose monitoring (FGM) to identify the differences between tofogliflozin and ipragliflozin in terms of efficacy in reducing glycemic variability and mitigate hypoglycemia risk.
METHODS


In this crossover study, 24 patients with type-2 diabetes mellitus (T2DM) receiving insulin glargine U300 therapy were randomly allocated to tofogliflozin and ipragliflozin or ipragliflozin and tofogliflozin group. Glycemic variability and hypoglycemia were compared using to the 3-day FGM data per treatment period.
RESULTS


Glucose level 2 h after each meal was significantly lower with tofogliflozin administration than with ipragliflozin administration. Time below the target glucose range after tofogliflozin administration was significantly lower than that after ipragliflozin administration (2.1% ± 4.4% vs. 8.7% ± 11.7%). The 24-h standard deviation of glucose level, mean amplitude of glycemic excursion, and mean percent time with nocturnal hypoglycemia after tofogliflozin administration were significantly lower than those after ipragliflozin administration.
CONCLUSIONS


Tofogliflozin was more effective and safer than ipragliflozin in reducing glycemic variability and mitigating hypoglycemia risk in patients with T2DM treated with insulin glargine U300.
TRIAL REGISTRATION


This trial was registered at the University Hospital Medical Information Network Clinical Trial Registry (no. UMIN000037158).",2020,Time below the target glucose range after tofogliflozin administration was significantly lower than that after ipragliflozin administration (2.1% ± 4.4% vs. 8.7% ± 11.7%).,"['24 patients with type-2 diabetes mellitus (T2DM) receiving insulin glargine U300 therapy', 'patients with T2DM treated with insulin glargine U300', 'Patients with Type-2 Diabetes']","['flash glucose monitoring (FGM', 'ipragliflozin', 'tofogliflozin and ipragliflozin or ipragliflozin and tofogliflozin group', 'tofogliflozin', 'Tofogliflozin', 'Tofogliflozin and Ipragliflozin', 'Sodium-glucose cotransporter 2 (SGLT2) inhibitors', 'tofogliflozin and ipragliflozin', 'Flash Glucose Monitoring']","['24-h standard deviation of glucose level, mean amplitude of glycemic excursion, and mean percent time with nocturnal hypoglycemia after tofogliflozin administration', 'glycemic variability and mitigating hypoglycemia risk', 'Efficacy and Safety', 'Glycemic variability and hypoglycemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C3492889', 'cui_str': 'ipragliflozin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0342315', 'cui_str': 'Nocturnal hypoglycemia'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",24.0,0.0292529,Time below the target glucose range after tofogliflozin administration was significantly lower than that after ipragliflozin administration (2.1% ± 4.4% vs. 8.7% ± 11.7%).,"[{'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Kawaguchi', 'Affiliation': 'Department of Internal Medicine, Minami Osaka Hospital, 1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan. y.kawaguchi@minamiosaka.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sawa', 'Affiliation': 'Department of Internal Medicine, Minami Osaka Hospital, 1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan.'}, {'ForeName': 'Yasuro', 'Initials': 'Y', 'LastName': 'Kumeda', 'Affiliation': 'Department of Internal Medicine, Minami Osaka Hospital, 1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00940-9']
2706,33063273,"The effect of dual-release versus conventional hydrocortisone on fatigue, measured by ecological momentary assessments.","PURPOSE


Replicating the physiological cortisol secretion is key in the treatment of glucocorticoid insufficient individuals and optimization may enhance quality of life. The study investigates fatigue measured by ecological momentary assessments in patients treated with conventional hydrocortisone compared with once-daily dual-release hydrocortisone (Plenadren).
METHODS


A 21-week open-label switch pilot trial included 30 patients with adrenal insufficiency due to hypopituitarism. Fatigue was assessed four times daily for 20 days using a momentary item version of the Multidimensional Fatigue Inventory on patients' usual hydrocortisone regimen. Participants switched treatment to an identical daily dose of Plenadren for 16 weeks where fatigue assessments were repeated. Change in fatigue and diurnal variation of fatigue was analyzed using mixed models for repeated measurements.
RESULTS


In four out of five fatigue subscales fatigue was significantly reduced 0.7-1.1 points (scales ranging from 4 to 20), when treated with Plenadren compared with conventional hydrocortisone, corresponding to small effect sizes below the scale-specific minimal important changes. However, 33% of the participants completing the study (9/27) experienced reductions in fatigue above the minimal important change. On Plenadren, we found larger between-person variances and smaller within-person variances. Finally, we identified diurnal fatigue curves for both treatments.
CONCLUSIONS


The Plenadren-related reduction in fatigue was significant but not necessarily of clinical importance when looking at a group level. However, there was a large interindividual variation in treatment effect, why patients with a large benefit in quality of life should be identified. Future RCTs should be powered to detect the effect magnitudes identified here.",2020,The Plenadren-related reduction in fatigue was significant but not necessarily of clinical importance when looking at a group level.,"['patients treated with', '30 patients with adrenal insufficiency due to hypopituitarism']","['conventional hydrocortisone', 'conventional hydrocortisone compared with once-daily dual-release hydrocortisone (Plenadren']","['fatigue subscales fatigue', 'Change in fatigue and diurnal variation of fatigue', 'diurnal fatigue curves', 'fatigue', 'Fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001623', 'cui_str': 'Hypoadrenalism'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0020635', 'cui_str': 'Hypopituitarism'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",30.0,0.0417176,The Plenadren-related reduction in fatigue was significant but not necessarily of clinical importance when looking at a group level.,"[{'ForeName': 'Victor Brun', 'Initials': 'VB', 'LastName': 'Boesen', 'Affiliation': 'Department of Endocrinology and Metabolism, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Stina Willemoes', 'Initials': 'SW', 'LastName': 'Borresen', 'Affiliation': 'Department of Endocrinology and Metabolism, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Christoffersen', 'Affiliation': 'Department of Endocrinology and Metabolism, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Klose', 'Affiliation': 'Department of Endocrinology and Metabolism, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Torquil', 'Initials': 'T', 'LastName': 'Watt', 'Affiliation': 'Department of Endocrinology and Metabolism, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Feldt-Rasmussen', 'Affiliation': 'Department of Endocrinology and Metabolism, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark. ufeldt@rh.dk.'}]",Endocrine,['10.1007/s12020-020-02507-x']
2707,33063277,"Response to Letter to the Editor Regarding ""A Multicentre, Randomised Clinical Trial to Compare a Topical Nitrizinc ®  Complex Solution Versus Cryotherapy for the Treatment of Anogenital Warts"".",,2020,,['Anogenital Warts'],['Topical Nitrizinc ®  Complex Solution Versus Cryotherapy'],[],"[{'cui': 'C0009663', 'cui_str': 'Genital warts'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]",[],,0.0723438,,"[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pontini', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico. UO Dermatologia, Via Pace 9, 20122, Milan, Italy. pontini.p@gmail.com.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Mastorino', 'Affiliation': 'Dermatologic Clinic, Department of Medical Sciences, AOU Città Della Salute E Della Scienza, University of Turin, Turin, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Gaspari', 'Affiliation': ""Unit of Dermatology, Head and Neck Department, Sant'Orsola Malpighi University Hospital, Bologna, Italy.""}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Granger', 'Affiliation': 'Innovation and Development, ISDIN, Barcelona, Spain.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ramoni', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico. UO Dermatologia, Via Pace 9, 20122, Milan, Italy.""}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Delmonte', 'Affiliation': 'Dermatologic Clinic, Department of Medical Sciences, AOU Città Della Salute E Della Scienza, University of Turin, Turin, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Evangelista', 'Affiliation': ""Unit of Dermatology, Head and Neck Department, Sant'Orsola Malpighi University Hospital, Bologna, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cusini', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico. UO Dermatologia, Via Pace 9, 20122, Milan, Italy.""}]",Dermatology and therapy,['10.1007/s13555-020-00450-3']
2708,33063296,Impact of Geriatric Pharmacy Specialist Interventions to Reduce Potentially Inappropriate Medication Among Hospitalized Elderly Patients at Medical Wards: A Prospective Quasi-Experimental Study.,"BACKGROUND


Elderly patients are at greater risk of receiving potentially inappropriate medications (PIMs) and developing adverse drug events. Identification and correction of PIMs is essential to maximize medication safety.
OBJECTIVE


To determine the prevalence of PIMs on admission in Thai elderly patients admitted to a medical ward and to compare changes of PIMs on discharge, following comprehensive care by a ward pharmacist with or without a geriatric pharmacy specialist.
PATIENTS AND METHOD


A prospective, quasi-experimental study was performed at a tertiary university hospital in Bangkok, Thailand. Patients aged ≥ 60 years who were admitted to the medical ward were recruited and allocated to one of two groups: intervention (IG) and control (CG). The CG received pharmaceutical care from the ward pharmacist. The IG received pharmaceutical care from the geriatric pharmacy specialist along with the ward pharmacist. The 2012 Beers criteria were used to identify PIMs on admission, during hospitalization, and on discharge.
RESULTS


Prevalence of PIMs on admission was 43.3% (N = 187). On discharge, prevalence of PIMs in the IG decreased significantly compared to that on admission (21.3% and 43.3%, p < 0.05) and was significantly lower than in the CG (21.3% and 40.9%, p = 0.036). Moreover, the percentage of patients without PIMs on discharge in the IG was significantly higher than in the CG (78.7% and 59.1%, p < 0.0001).
CONCLUSION


Use of PIMs was common among hospitalized elderly patients on admission. Pharmaceutical care provided by a geriatric pharmacy specialist in conjunction with a ward pharmacist significantly reduced the prevalence of PIMs on discharge compared with on admission.",2020,Pharmaceutical care provided by a geriatric pharmacy specialist in conjunction with a ward pharmacist significantly reduced the prevalence of PIMs on discharge compared with on admission.,"['Patients aged\u2009≥', 'A prospective, quasi-experimental study was performed at a tertiary university hospital in Bangkok, Thailand', 'Hospitalized Elderly Patients at Medical Wards', 'hospitalized elderly patients on admission', '60\xa0years who were admitted to the medical ward', 'Thai elderly patients admitted to a medical ward and to compare changes of PIMs on discharge, following comprehensive care by a ward pharmacist with or without a geriatric pharmacy specialist', 'Elderly patients']","['intervention (IG) and control (CG', 'Geriatric Pharmacy Specialist Interventions']","['discharge, prevalence of PIMs', 'prevalence of PIMs on discharge', 'percentage of patients without PIMs on discharge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009586', 'cui_str': 'Comprehensive Healthcare'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.0117656,Pharmaceutical care provided by a geriatric pharmacy specialist in conjunction with a ward pharmacist significantly reduced the prevalence of PIMs on discharge compared with on admission.,"[{'ForeName': 'Wajanakorn', 'Initials': 'W', 'LastName': 'Chivapricha', 'Affiliation': 'College of Pharmacy, Rangsit University, Pathumthani, Thailand.'}, {'ForeName': 'Varalak', 'Initials': 'V', 'LastName': 'Srinonprasert', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Thanarat', 'Initials': 'T', 'LastName': 'Suansanae', 'Affiliation': 'Division of Clinical Pharmacy, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand. thanarat.sua@mahidol.ac.th.'}]",Drugs - real world outcomes,['10.1007/s40801-020-00214-7']
2709,33063308,"[The ""UPGRADE"" Study Protocol: Creative Strengthening Groups as an Innovative Preventive Intervention for Healthcare Workers].","Health care workers are subjected to particular job strains. Besides workload, exposure to the risks of violence and traumatic experiences can result in negative health effects. To date, there are hardly any preventive interventions. Supported by the German Innovationsfonds, we want to evaluate the effectiveness of a more intensive intervention for health care workers, the Creative Strengthening Groups. In this randomised controlled trial, 366 participants will be assigned to the intervention or the control group. The intervention group will participate in the Creative Strengthening Groups. At baseline and follow-up, all participants will complete questionnaires. The primary outcome is the change in job satisfaction as measured with the validated Copenhagen Psychosocial Questionnaire (COPSOQ). Secondary outcomes will be obtained by questionnaires that include items on psychosocial working conditions and organisational changes. We hypothesise that participation in the UPGRADE intervention will improve job satisfaction and thus constitute a structural and behavioural prevention strategy for the promotion of psychological well-being of health care workers.",2020,We hypothesise that participation in the UPGRADE intervention will improve job satisfaction and thus constitute a structural and behavioural prevention strategy for the promotion of psychological well-being of health care workers.,"['Healthcare Workers', '366 participants']",[],"['psychosocial working conditions and organisational changes', 'change in job satisfaction as measured with the validated Copenhagen Psychosocial Questionnaire (COPSOQ']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]",[],"[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",366.0,0.0453915,We hypothesise that participation in the UPGRADE intervention will improve job satisfaction and thus constitute a structural and behavioural prevention strategy for the promotion of psychological well-being of health care workers.,"[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pieper', 'Affiliation': 'Institut für Medizinische Informatik, Biometrie und Epidemiologie, Universitätsklinikum Essen.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Schröer', 'Affiliation': 'Institut für Medizinische Informatik, Biometrie und Epidemiologie, Universitätsklinikum Essen.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Spanier', 'Affiliation': 'Institut für Medizinische Informatik, Biometrie und Epidemiologie, Universitätsklinikum Essen.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Psychotherapie und Neurologie, Klinik für Psychiatrie, Helios Marien Klinik Duisburg.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Russ', 'Affiliation': 'Prävention, Novitas BKK, Duisburg.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Baer', 'Affiliation': 'ISI - Trauma, ISI - Institut für soziale Innovationen, Duisburg.'}]","Psychotherapie, Psychosomatik, medizinische Psychologie",['10.1055/a-1248-2412']
2710,33063321,Randomized controlled trial of a brief online self-compassion intervention for mothers of infants: Effects on mental health outcomes.,"OBJECTIVE


To test the effectiveness of a brief self-compassion intervention in improving mental health outcomes for mothers of infants.
METHOD


A randomized controlled trial study design was used. A community sample of mothers of infants (<2 years) completed measures of self-compassion, fears of compassion, psychological flexibility, depression, anxiety, stress, symptoms of posttraumatic stress, and infant feeding experiences. Mothers randomized to intervention received access to online self-compassion resources, and 248 mothers (intervention n = 94, waitlist-control n = 154) completed postintervention assessment 8 weeks later.
RESULTS


Overall, 62.8% (n = 59) of intervention participants accessed the resources per-protocol, and lower fear of compassion scores predicted resource use. At postintervention, mothers who used the resources had improved scores for posttraumatic stress symptoms (95% confidence interval [CI] = 0.31-5.47, p = .028), depression (95% CI = 0.15-2.01, p = .023), self-compassionate action (95% CI = 0.41-3.45, p = .012), and engagement with compassion from others (95% CI = 0.22-5.49, p = .034) compared to waitlist-control. Fears of compassion moderated intervention effectiveness. There were no effects on other outcome variables.
CONCLUSIONS


Findings support the potential effectiveness of interventions based on compassion-focused therapy to improve maternal mental health.",2020,"At postintervention, mothers who used the resources had improved scores for posttraumatic stress symptoms (95% confidence interval [CI] = 0.31-5.47, p = .028), depression (95% CI = 0.15-2.01, p = .023), self-compassionate action (95% CI = 0.41-3.45, p = .012), and engagement with compassion from others (95% CI = 0.22-5.49, p = .034) compared to waitlist-control.","['mothers of infants', 'A community sample of mothers of infants (<2 years']","['online self-compassion intervention', 'intervention received access to online self-compassion resources, and 248 mothers (intervention n\u2009=\u200994, waitlist-control n\u2009=\u2009154) completed postintervention assessment 8 weeks later', 'brief self-compassion intervention']","['self-compassion, fears of compassion, psychological flexibility, depression, anxiety, stress, symptoms of posttraumatic stress, and infant feeding experiences', 'mental health outcomes', 'self-compassionate action', 'scores for posttraumatic stress symptoms', 'maternal mental health', 'depression']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",,0.125738,"At postintervention, mothers who used the resources had improved scores for posttraumatic stress symptoms (95% confidence interval [CI] = 0.31-5.47, p = .028), depression (95% CI = 0.15-2.01, p = .023), self-compassionate action (95% CI = 0.41-3.45, p = .012), and engagement with compassion from others (95% CI = 0.22-5.49, p = .034) compared to waitlist-control.","[{'ForeName': 'Georgina R', 'Initials': 'GR', 'LastName': 'Lennard', 'Affiliation': 'Parenting and Family Support Centre, School of Psychology, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Mitchell', 'Affiliation': 'Parenting and Family Support Centre, School of Psychology, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Koa', 'Initials': 'K', 'LastName': 'Whittingham', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}]",Journal of clinical psychology,['10.1002/jclp.23068']
2711,33063477,"Multiple-Dose Pharmacokinetics, Safety, and Tolerability of Aprocitentan, a Dual Endothelin Receptor Antagonist, in Healthy Japanese and Caucasian Subjects.","Aprocitentan is an orally active dual endothelin receptor antagonist currently in development for treatment of difficult-to-control (resistant) hypertension. In phase 1 and 2 studies, aprocitentan has been characterized predominantly in Caucasian subjects. In this bridging, double-blind study, 20 healthy Japanese and Caucasian male and female subjects received 25 mg of aprocitentan or placebo once daily for 10 days and were monitored until 216 hours after the last dosing. The pharmacokinetics of aprocitentan were similar between ethnicities. At steady state, maximum plasma concentration was reached at 4 and 3 hours, and elimination half-life was 49.1 and 48.8 hours for Japanese and Caucasian subjects, respectively. The accumulation index was around 3 for both populations. Geometric means ratios for maximum plasma concentration and area under the plasma concentration-time curve during 1 dosing interval were around 1, with 90% confidence interval ranging from 0.87 to 1.30. Aprocitentan was safe and well tolerated in both groups. As no clinically relevant differences were found between Japanese and Caucasian subjects, it is unlikely that the pharmacokinetics of aprocitentan would differ significantly between Caucasian subjects and other ethnicities. Aprocitentan can therefore be administered at a dose level of up to 25 mg in any ethnicity without dose adjustment.",2020,The pharmacokinetics of aprocitentan were similar between ethnicities.,"['Japanese and Caucasian subjects', 'Caucasian subjects', '20 healthy Japanese and Caucasian male and female subjects', 'Caucasian subjects and other ethnicities', 'Healthy Japanese and Caucasian Subjects']",['25\xa0mg of aprocitentan or placebo'],"['accumulation index', 'Geometric means ratios for maximum plasma concentration and area under the plasma concentration-time curve', 'maximum plasma concentration', 'Multiple-Dose Pharmacokinetics, Safety, and Tolerability', 'safe and well tolerated']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",20.0,0.0445445,The pharmacokinetics of aprocitentan were similar between ethnicities.,"[{'ForeName': 'Magda S C', 'Initials': 'MSC', 'LastName': 'Fontes', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Patricia N', 'Initials': 'PN', 'LastName': 'Sidharta', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.881']
2712,33063541,Ingesting a Post-Workout Vegan-Protein Multi-Ingredient Expedites Recovery after Resistance Training in Trained Young Males.,"Post workout multi-ingredient admixtures are commonly used to maximize recovery after exercise. The present double-blind, cross-over study compared the acute effects of ingesting a protein-vegan multi-ingredient (VGMT) vs. maltodextrin (MALT) on indices of muscle function. Ten trained males, (26.8 ± 1.9 years) performed two identical, 3-day resistance training periods (one workout-session per day) while receiving either VGMT or MALT (10 min after the completion of each workout). Following a baseline evaluation, we conducted assessments at, 1-h, 24-h and 48-h after the 3-day training period. Primary outcome included the evoked tensiomyography contraction velocity (Vc) of vastus medialis (VM), biceps femoris long head (BFLH) and anterior deltoids (AD). Secondary outcomes involved strength and power performance while the other tensiomyography variables [muscle displacement (Dm), contraction time (Tc)] were considered as exploratory. After 1-h, all the tensiomyography variables measured at VM and BFLH were similarly depressed in both treatments. Only MALT showed a significantly lower Vc (-0.02 m .   s   -1 , 95% CI, -0.04, -0.01) in the AD. After 24-h, the VGMT treatment normalized all tensiomyography values. Conversely, impaired scores were observed in Vc for the VM (-0.03 m .   s   -1 , 95% CI, -0.06, -0.01) and BFLH (-0.02 m .   s   -1 , 95% CI, -0.05, 0.01) in the MALT treatment. Particularly, the Vc in VM was lower ( p  = 0.043) in MALT compared to VGMT. Overall, both treatments required 48-h to regain their performance capacity; however, VGMT produced better vertical jump and squat performance at 24-h vs. MALT. Compared to MALT, a vegan-protein multi-ingredient appears to hasten the recovery of muscular function over a 24-h period.",2020,"Particularly, the Vc in VM was lower ( p  = 0.043) in MALT compared to VGMT.","['Trained Young Males', 'Ten trained males, (26.8\u2009±\u20091.9\u2009years) performed two identical']","['MALT', 'protein-vegan multi-ingredient (VGMT) vs. maltodextrin (MALT', '3-day resistance training periods (one workout-session per day) while receiving either VGMT or MALT', 'VGMT']","['strength and power performance while the other tensiomyography variables [muscle displacement (Dm), contraction time (Tc', 'vertical jump and squat performance', 'Vc in VM', 'evoked tensiomyography contraction velocity (Vc) of vastus medialis (VM), biceps femoris long head (BFLH) and anterior deltoids (AD', 'BFLH', 'tensiomyography variables measured at VM and BFLH']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205280', 'cui_str': 'Identical'}]","[{'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0344353', 'cui_str': 'Vegan'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0224445', 'cui_str': 'Structure of vastus medialis muscle'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0224449', 'cui_str': 'Biceps femoris muscle structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",10.0,0.187023,"Particularly, the Vc in VM was lower ( p  = 0.043) in MALT compared to VGMT.","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Naclerio PhD', 'Affiliation': 'Department of Sport Science and Physical Education, Institute for Lifecourse Development, Centre for Chronic Illness and Ageing, University of Greenwich, United Kingdom.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Seijo PhD', 'Affiliation': 'Department of Sport Science and Physical Education, Institute for Lifecourse Development, Centre for Chronic Illness and Ageing, University of Greenwich, United Kingdom.'}, {'ForeName': 'Conrad P', 'Initials': 'CP', 'LastName': 'Earnest PhD', 'Affiliation': 'Department of Health and Kinesiology, Texas A&M University, College Station, TX, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Puente-Fernández MSc', 'Affiliation': 'Department of Sport Science and Physical Education, Institute for Lifecourse Development, Centre for Chronic Illness and Ageing, University of Greenwich, United Kingdom.'}, {'ForeName': 'Eneko', 'Initials': 'E', 'LastName': 'Larumbe-Zabala PhD', 'Affiliation': 'School of Doctorate and Research, European University of Madrid, Madrid, Spain.'}]",Journal of dietary supplements,['10.1080/19390211.2020.1832640']
2713,33063570,Implementing a Novel Workplace Smoking Cessation Intervention Targeting Hispanic/Latino Construction Workers: A Pilot Cluster Randomized Trial.,"BACKGROUND


U.S. Hispanic/Latino construction workers constitute a large and historically underserved group in terms of smoking cessation services. Using formative research, we developed a worksite smoking cessation intervention tailored to the life/work circumstances of these workers.
AIMS


This study aims to examine the feasibility, acceptability, and potential efficacy of the developed intervention ""Enhanced Care"" (EC; one group behavioral counseling session provided around the food truck + fax referral to tobacco quitline [QL] + 8-week nicotine replacement treatment [NRT]) compared with ""Standard Care"" (SC; fax referral to tobacco QL + 8-week NRT) in a pilot, two-arm, cluster randomized controlled trial.
METHOD


In collaboration with construction site safety managers, a sample of 17 construction sites (EC: nine sites/65 smokers; SC: eight sites/69 smokers) was enrolled. Participants received two follow-ups at 3 and 6 months after enrollment. Feasibility outcomes were enrollment rate, adherence to treatment, and 6-month retention rates. The primary efficacy outcome was 6 months prolonged abstinence verified by expired carbon monoxide <10 ppm.
RESULTS


Enrollment rate was high (85.9%). Six-month follow-up rates were acceptable (EC = 76.9%, SC = 66.6%). Adherence to treatment was better in the EC group (received worksite intervention: EC = 93.8%, SC = 88.4%; contacted by QL: EC = 49.2%, SC = 40.6%). Abstinence rates were 27.7% for the EC and 20.3% for the SC ( p  = .315).
DISCUSSION


The developed intervention was feasible and acceptable, and it substantially improved abstinence among Hispanic/Latino workers. The involvement of safety managers was essential to the implementation of the intervention. Training safety managers to deliver the intervention has great potential to implement a sustainable smoking cessation service in the construction sector.",2020,"Abstinence rates were 27.7% for the EC and 20.3% for the SC ( p  = .315).
","['Targeting Hispanic/Latino Construction Workers', '17 construction sites (EC: nine sites/65 smokers; SC: eight sites/69 smokers) was enrolled']","['Standard Care"" (SC; fax referral to tobacco QL + 8-week NRT', 'worksite intervention: EC', 'intervention ""Enhanced Care"" (EC', 'tobacco quitline [QL] + 8-week nicotine replacement treatment [NRT', 'worksite smoking cessation intervention', 'Novel Workplace Smoking Cessation Intervention']","['enrollment rate, adherence to treatment, and 6-month retention rates', 'prolonged abstinence verified by expired carbon monoxide <10 ppm', 'Abstinence rates']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0403066', 'cui_str': 'Construction worker'}, {'cui': 'C0337062', 'cui_str': 'Construction site'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085205', 'cui_str': 'Fax'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439187', 'cui_str': 'ppm'}]",,0.057977,"Abstinence rates were 27.7% for the EC and 20.3% for the SC ( p  = .315).
","[{'ForeName': 'Taghrid', 'Initials': 'T', 'LastName': 'Asfar', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Kristopher L', 'Initials': 'KL', 'LastName': 'Arheart', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'McClure', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Estefania C', 'Initials': 'EC', 'LastName': 'Ruano-Herreria', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Noella A', 'Initials': 'NA', 'LastName': 'Dietz', 'Affiliation': 'Broward Health Systems, Fort Lauderdale, FL, USA.'}, {'ForeName': 'Kenneth D', 'Initials': 'KD', 'LastName': 'Ward', 'Affiliation': 'School of Public Health, The University of Memphis, Memphis, TN, USA.'}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Caban-Martinez', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Samano Martin Del Campo', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Lee', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198120960395']
2714,33063619,Impact of Graphic Warning Messages on Intentions to Use Alternate Tobacco Products.,"Graphic cigarette warnings increase quit attempts. Perceived message effectiveness and message avoidance are predictive of later quit attempts. We sought to examine whether randomized exposure to warning messages would inadvertently increase intentions to use alternate tobacco products while enhancing attempts to quit cigarettes. An online survey of 1392 adult smokers in the US asked participants to rate six randomly selected tobacco warnings (from a set of 319) on perceived effectiveness and avoidance intentions. These two indicators of message effectiveness were calculated at the message-level and then at the individual campaign-level to facilitate causal inference. After viewing a message campaign of six warning messages, participants indicated their intentions to use alternate tobacco products. Sixty-eight percent of participants reported some intention to use e-cigarettes and intentions to use other alternate tobacco products ranged from 31% to 40%. Campaigns of messages eliciting higher avoidance increased the odds of intending to use hookah (aOR: 4.32), smokeless tobacco (aOR: 4.88), and snus (aOR: 8.06), but not the intention to use electronic cigarettes. These relationships are mediated by intentions to quit smoking (all  p  <.05). Viewing campaigns with higher campaign-level perceived effectiveness increased the intentions to quit, which in turn increased intentions to try alternate tobacco products. Our findings increase the tobacco control community's understanding of unintended consequences of graphic tobacco warnings.",2020,"Campaigns of messages eliciting higher avoidance increased the odds of intending to use hookah (aOR: 4.32), smokeless tobacco (aOR: 4.88), and snus (aOR: 8.06), but not the intention to use electronic cigarettes.",['1392 adult smokers in the US asked participants to rate six randomly selected tobacco warnings (from a set of 319) on perceived'],['Graphic Warning Messages'],"['some intention to use e-cigarettes and intentions to use other alternate tobacco products', 'effectiveness and avoidance intentions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205452', 'cui_str': '6'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",[],"[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1392.0,0.0296029,"Campaigns of messages eliciting higher avoidance increased the odds of intending to use hookah (aOR: 4.32), smokeless tobacco (aOR: 4.88), and snus (aOR: 8.06), but not the intention to use electronic cigarettes.","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Morgan', 'Affiliation': 'Annenberg School for Communication, University of Pennsylvania , Philadelphia, USA.'}, {'ForeName': 'Jazmyne A', 'Initials': 'JA', 'LastName': 'Sutton', 'Affiliation': 'Annenberg School for Communication, University of Pennsylvania , Philadelphia, USA.'}, {'ForeName': 'Sijia', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Annenberg School for Communication, University of Pennsylvania , Philadelphia, USA.'}, {'ForeName': 'Joseph N', 'Initials': 'JN', 'LastName': 'Cappella', 'Affiliation': 'Annenberg School for Communication, University of Pennsylvania , Philadelphia, USA.'}]",Journal of health communication,['10.1080/10810730.2020.1827097']
2715,33063862,"Efficacy of Galcanezumab for Migraine Prevention in Patients With a Medical History of Anxiety and/or Depression: A Post Hoc Analysis of the Phase 3, Randomized, Double-Blind, Placebo-Controlled REGAIN, and Pooled EVOLVE-1 and EVOLVE-2 Studies.","OBJECTIVE


This post hoc analysis evaluated the efficacy of galcanezumab for the prevention of migraine in patients with and without comorbid anxiety and/or depression.
BACKGROUND


Patients with migraine have a higher risk of anxiety and/or depression. Given the high prevalence of psychiatric symptoms and their potential negative prognostic impact, determining the efficacy of migraine treatments in patients with these comorbidities is important.
METHODS


The results of 2 phase 3 episodic migraine studies of patients with 4-14 migraine headache days (MHD) per month were pooled. A third chronic migraine study, which was evaluated separately, enrolled patients with ≥15 headache days per month, of which ≥8 had migraine-like features. Patients in all 3 studies were randomized 2:1:1 to placebo, galcanezumab 120 mg, or galcanezumab 240 mg. The efficacy of galcanezumab on migraine was measured in subgroups of patients with anxiety and/or depression (current or past) and patients without. A repeated measures model was used to compare treatment groups within each subgroup and to test for consistency of treatment effect across the anxiety/depression subgroups (subgroup-by-treatment interaction) during the double-blind treatment phases.
RESULTS


Among 1773 intent-to-treat patients with episodic migraine, both doses of galcanezumab demonstrated statistically significant improvements relative to placebo in overall number of MHD for the subgroups of patients with anxiety and/or depression (mean change difference from placebo [95% CI]: -2.07 [-2.81, -1.33] for galcanezumab 120 mg [P < .001], -1.91 [-2.78, -1.04] for 240 mg [P < .001]) and without anxiety and/or depression (mean change difference from placebo [95% CI]: -1.92 [-2.36, -1.47] for 120 mg [P < .001], -1.77 [-2.20, -1.33] for 240 mg [P < .001]), as was observed for the secondary outcomes of MHD with acute medication use and functional impairment. Among 1113 intent-to-treat patients with chronic migraine, those with anxiety and/or depression had significant reductions in overall MHD frequency with the 240-mg dose (mean change difference from placebo [95% CI]: -1.92 [-3.52, -0.33]; P = .018), whereas significant reductions were observed at both the 120-mg (mean change difference from placebo [95% CI]: -2.29 [-3.26, -1.31]; P < .001) and 240-mg (-1.85 [-2.83, -0.87]; P < .001) doses in patients without anxiety and/or depressions. Significant reductions (P < .01) in MHD with acute medication use were observed at both doses within both anxiety/depression subgroups and for overall functional impairment for patients without anxiety and/or depression, though neither dose significantly reduced overall functional impairment beyond placebo in the subgroup with anxiety and/or depression. In the episodic and chronic migraine studies, the subgroup-by-treatment interaction was not statistically significant for MHD, MHD with acute medication use, or functional impairment (chronic study only), suggesting a lack of evidence of differential effect between subgroups. Furthermore, differences between subgroups in the mean change differences from placebo, as well as overlapping 95% confidence intervals for the subgroups, indicated lack of a clinical or statistical difference between subgroups for these outcome variables. There was a significantly higher percentage of patients with episodic migraine attaining ≥50%, ≥75%, and 100% reductions, and a higher percentage of patients with chronic migraine attaining ≥50% and ≥75% reductions from baseline with galcanezumab compared with placebo, regardless of medical history of anxiety and/or depression.
CONCLUSIONS


A medical history of anxiety and/or depression does not seem to interfere with response to galcanezumab among patients with episodic migraine, and both doses of galcanezumab appear efficacious for these individuals regardless of this psychiatric history. Among patients with chronic migraine and comorbid anxiety and/or depression, the 240-mg dose, but not the 120-mg dose, significantly decreased overall MHD, but neither dose resulted in significantly greater functional improvement. Patients with migraine and comorbid anxiety and/or depression often require additional interventions, and this may be more important in chronic migraine.",2020,"Significant reductions (P < .01) in MHD with acute medication use were observed at both doses within both anxiety/depression subgroups and for overall functional impairment for patients without anxiety and/or depression, though neither dose significantly reduced overall functional impairment beyond placebo in the subgroup with anxiety and/or depression.","['enrolled patients with ≥15 headache days per month, of which ≥8 had migraine-like features', 'Patients With a Medical History of Anxiety', 'subgroups of patients with anxiety and/or depression (current or past) and patients without', 'patients with these comorbidities is important', 'Patients with migraine and comorbid anxiety and/or depression often require additional interventions', 'and/or Depression', 'patients with episodic migraine', 'patients with 4-14 migraine headache days (MHD) per month were pooled', 'patients with and without comorbid anxiety and/or depression']","['Galcanezumab', 'galcanezumab', 'placebo', 'placebo, galcanezumab 120\xa0mg, or galcanezumab 240\xa0mg', 'Placebo']","['chronic migraine', 'MHD with acute medication use and functional impairment', 'comorbid anxiety and/or depression', 'migraine', 'anxiety and/or depression', 'overall MHD', 'overall functional impairment', 'functional improvement', 'overall number of MHD', 'episodic migraine', 'overall MHD frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1444635', 'cui_str': 'Current or past'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0337051', 'cui_str': 'Pool'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319600', 'cui_str': '240'}]","[{'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.162567,"Significant reductions (P < .01) in MHD with acute medication use were observed at both doses within both anxiety/depression subgroups and for overall functional impairment for patients without anxiety and/or depression, though neither dose significantly reduced overall functional impairment beyond placebo in the subgroup with anxiety and/or depression.","[{'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Smitherman', 'Affiliation': 'Department of Psychology, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Gretchen E', 'Initials': 'GE', 'LastName': 'Tietjen', 'Affiliation': 'Department of Neurology, University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Kory', 'Initials': 'K', 'LastName': 'Schuh', 'Affiliation': 'Medical Affairs, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Skljarevski', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lipsius', 'Affiliation': 'Department of Statistics, Syneos Health, Raleigh, NC, USA.'}, {'ForeName': 'Deborah N', 'Initials': 'DN', 'LastName': ""D'Souza"", 'Affiliation': 'Clinical Solutions, Syneos Health, Raleigh, NC, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pearlman', 'Affiliation': 'Medical Affairs, Eli Lilly and Company, Indianapolis, IN, USA.'}]",Headache,['10.1111/head.13970']
2716,33063882,Nalbuphine on postoperative gastrointestinal tract dysfunction after laparoscopic surgery for gynecological malignancies: a randomized controlled trial.,"The aim of this study was to compare the effects of nalbuphine and sufentanil on the gastrointestinal (GI) tract after laparoscopic surgery for gynaecological malignancies. A total of 100 patients with American Society of Anesthesiologists (ASA) physical status I-II undergoing laparoscopic radical hysterectomy under general anaesthesia were enrolled. The patients were randomised to receive sufentanil (Group S) or nalbuphine (Group N) intraoperatively and postoperatively. The time to first passage of flatus, the time to first defaecation, the time to toleration of diet, the serum gastrin level, and the duration of hospital stay of the groups were compared. The Visual Analogue Scale (VAS) score for postoperative pain, the number of dispensed patient-controlled analgesics (PCAs), and the prevalence of postoperative nausea, vomiting, and dizziness of the groups were also compared. The time to first passage of flatus (p = 0.551), time to first defaecation (p = 0.310), time to toleration of diet (p = 0.182), serum gastrin level (p = 0.397), prevalence of postoperative nausea (p = 0.920) and vomiting (p = 0.334), number of dispensed PCAs (p = 0.167), and the duration of hospital stay (p = 0.482) of the two groups were not significantly different. The VAS scores at 6 h (p = 0.008), 12 h (p = 0.002), and 24 h (p = 0.013) postoperatively were lower in Group N than in Group S. In conclusion, nalbuphine was not associated with improved postoperative GI dysfunction after laparoscopic surgery for gynaecological malignancies, but it was associated with reduced postoperative pain.",2020,"The time to first passage of flatus (p = 0.551), time to first defaecation (p = 0.310), time to toleration of diet (p = 0.182), serum gastrin level (p = 0.397), prevalence of postoperative nausea (p = 0.920) and vomiting (p = 0.334), number of dispensed PCAs (p = 0.167), and the duration of hospital stay (p = 0.482) of the two groups were not significantly different.","['gynecological malignancies', '100 patients with American Society of Anesthesiologists (ASA) physical status I-II undergoing laparoscopic radical hysterectomy under general anaesthesia were enrolled', 'gastrointestinal (GI) tract after laparoscopic surgery for gynaecological malignancies']","['sufentanil', 'nalbuphine', 'nalbuphine and sufentanil', 'laparoscopic surgery', 'Nalbuphine']","['serum gastrin level', 'Visual Analogue Scale (VAS) score for postoperative pain, the number of dispensed patient-controlled analgesics (PCAs), and the prevalence of postoperative nausea, vomiting, and dizziness', 'VAS scores', 'time to first passage of flatus, the time to first defaecation, the time to toleration of diet, the serum gastrin level, and the duration of hospital stay', 'time to first defaecation', 'number of dispensed PCAs', 'duration of hospital stay', 'time to toleration of diet', 'postoperative GI dysfunction', 'time to first passage of flatus', 'prevalence of postoperative nausea', 'postoperative gastrointestinal tract dysfunction', 'vomiting', 'postoperative pain']","[{'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0404093', 'cui_str': 'Laparoscopic radical hysterectomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0428386', 'cui_str': 'Serum gastrin measurement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}]",100.0,0.065248,"The time to first passage of flatus (p = 0.551), time to first defaecation (p = 0.310), time to toleration of diet (p = 0.182), serum gastrin level (p = 0.397), prevalence of postoperative nausea (p = 0.920) and vomiting (p = 0.334), number of dispensed PCAs (p = 0.167), and the duration of hospital stay (p = 0.482) of the two groups were not significantly different.","[{'ForeName': 'Jia-Wei', 'Initials': 'JW', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital, Fudan University, No.419 Fangxie Rd., Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital, Fudan University, No.419 Fangxie Rd., Shanghai, China.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital, Fudan University, No.419 Fangxie Rd., Shanghai, China.'}, {'ForeName': 'Jian-Ying', 'Initials': 'JY', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital, Fudan University, No.419 Fangxie Rd., Shanghai, China.'}, {'ForeName': 'Shao-Qiang', 'Initials': 'SQ', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital, Fudan University, No.419 Fangxie Rd., Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital, Fudan University, No.419 Fangxie Rd., Shanghai, China.'}]",Clinical and experimental pharmacology & physiology,['10.1111/1440-1681.13421']
2717,33063909,Long-Term Survival of Participants in the CENTAUR Trial of Sodium Phenylbutyrate-Taurursodiol in ALS.,"INTRODUCTION


An orally administered, fixed-dose coformulation of sodium phenylbutyrate-taurursodiol (PB-TURSO) significantly slowed functional decline in a randomized, placebo-controlled, phase 2 trial in ALS (CENTAUR). Here, we report results of a long-term survival analysis of participants in CENTAUR.
METHODS


In CENTAUR, adults with ALS were randomized 2:1 to PB-TURSO or placebo. Participants completing the 6-month (24-week) randomized phase were eligible to receive PB-TURSO in the open-label extension (OLE). An all-cause mortality analysis (35-month maximum follow-up post-randomization) incorporated all randomized participants. Participants and site investigators were blinded to treatment assignments through the duration of follow-up of this analysis.
RESULTS


Vital status was obtained for 135 of 137 participants originally randomized in CENTAUR. Median overall survival was 25.0 months among participants originally randomized to PB-TURSO and 18.5 months among those originally randomized to placebo (hazard ratio, 0.56; 95% CI, 0.34-0.92; P=0.023).
DISCUSSION


Initiation of PB-TURSO treatment at baseline resulted in a 6.5-month longer median survival as compared to placebo. Combined with results from CENTAUR, these results suggest that PB-TURSO has both functional and survival benefits in ALS.",2020,"Median overall survival was 25.0 months among participants originally randomized to PB-TURSO and 18.5 months among those originally randomized to placebo (hazard ratio, 0.56; 95% CI, 0.34-0.92; P=0.023).
","['adults with ALS', '135 of 137 participants originally randomized in CENTAUR', 'participants in CENTAUR']","['sodium phenylbutyrate-taurursodiol (PB-TURSO', 'placebo', 'PB-TURSO in the open-label extension (OLE']","['Median overall survival', 'median survival']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C4517569', 'cui_str': '137'}]","[{'cui': 'C0718066', 'cui_str': 'sodium phenylbutyrate'}, {'cui': 'C0031465', 'cui_str': 'Phenylbutyrates'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",137.0,0.647067,"Median overall survival was 25.0 months among participants originally randomized to PB-TURSO and 18.5 months among those originally randomized to placebo (hazard ratio, 0.56; 95% CI, 0.34-0.92; P=0.023).
","[{'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Paganoni', 'Affiliation': 'Sean M. Healey and AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hendrix', 'Affiliation': 'Pentara Corporation, Millcreek, Utah.'}, {'ForeName': 'Samuel P', 'Initials': 'SP', 'LastName': 'Dickson', 'Affiliation': 'Pentara Corporation, Millcreek, Utah.'}, {'ForeName': 'Newman', 'Initials': 'N', 'LastName': 'Knowlton', 'Affiliation': 'Pentara Corporation, Millcreek, Utah.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Berry', 'Affiliation': 'Sean M. Healey and AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Elliott', 'Affiliation': 'Swedish Neuroscience Institute, Washington.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Maiser', 'Affiliation': 'Hennepin Healthcare, Minneapolis, Minnesota.'}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Caress', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, North Carolina, Carolina.'}, {'ForeName': 'Margaret Ayo', 'Initials': 'MA', 'LastName': 'Owegi', 'Affiliation': 'University of Massachusetts Memorial Medical Center, Worcester, Massachusetts.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Quick', 'Affiliation': 'Department of Neurology, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wymer', 'Affiliation': 'Department of Neurology, University of Florida College of Medicine, Florida.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Goutman', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Daragh', 'Initials': 'D', 'LastName': 'Heitzman', 'Affiliation': 'Texas Neurology, Dallas, Texas.'}, {'ForeName': 'Terry D', 'Initials': 'TD', 'LastName': 'Heiman-Patterson', 'Affiliation': 'Department of Neurology, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Carlayne E', 'Initials': 'CE', 'LastName': 'Jackson', 'Affiliation': 'The University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Quinn', 'Affiliation': 'Department of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Rothstein', 'Affiliation': 'Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Kasarskis', 'Affiliation': 'Department of Neurology, University of Kentucky College of Medicine, Lexington, Kentucky.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'California Pacific Medical Center Research Institute and Forbes Norris MDA/ALS Research and Treatment Center, California.'}, {'ForeName': 'Liberty', 'Initials': 'L', 'LastName': 'Jenkins', 'Affiliation': 'California Pacific Medical Center Research Institute and Forbes Norris MDA/ALS Research and Treatment Center, California.'}, {'ForeName': 'Shafeeq', 'Initials': 'S', 'LastName': 'Ladha', 'Affiliation': 'Gregory W. Fulton ALS Center, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Stephen N', 'Initials': 'SN', 'LastName': 'Scelsa', 'Affiliation': 'Department of Neurology, Mount Sinai Beth, Israel, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Tuan H', 'Initials': 'TH', 'LastName': 'Vu', 'Affiliation': 'Department of Neurology, University of South Florida Morsani College of Medicine, Florida.'}, {'ForeName': 'Christina N', 'Initials': 'CN', 'LastName': 'Fournier', 'Affiliation': 'Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Glass', 'Affiliation': 'Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Johnson', 'Affiliation': 'Department of Neurology, Ochsner Health System, New Orleans, Louisiana.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Swenson', 'Affiliation': 'Department of Neurology, University of Iowa Carver College of Medicine, Iowa.'}, {'ForeName': 'Namita A', 'Initials': 'NA', 'LastName': 'Goyal', 'Affiliation': 'Department of Neurology, University of California, California.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Pattee', 'Affiliation': 'Neurology Associates, Lincoln, Nebraska.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Andres', 'Affiliation': 'Independent consultant, Nobleboro, ME.'}, {'ForeName': 'Suma', 'Initials': 'S', 'LastName': 'Babu', 'Affiliation': 'Sean M. Healey and AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Chase', 'Affiliation': 'Sean M. Healey and AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Dagostino', 'Affiliation': 'Sean M. Healey and AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Gregory W. Fulton ALS Center, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Gale', 'Initials': 'G', 'LastName': 'Kittle', 'Affiliation': 'Gregory W. Fulton ALS Center, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Eydinov', 'Affiliation': 'Sean M. Healey and AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'McGovern', 'Affiliation': 'Sean M. Healey and AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ostrow', 'Affiliation': 'Sean M. Healey and AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Pothier', 'Affiliation': 'Sean M. Healey and AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Randall', 'Affiliation': 'Gregory W. Fulton ALS Center, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Shefner', 'Affiliation': 'Gregory W. Fulton ALS Center, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Sherman', 'Affiliation': 'Sean M. Healey and AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'St Pierre', 'Affiliation': 'Sean M. Healey and AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Tustison', 'Affiliation': 'Sean M. Healey and AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Prasha', 'Initials': 'P', 'LastName': 'Vigneswaran', 'Affiliation': 'Sean M. Healey and AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Sean M. Healey and AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Sean M. Healey and AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wittes', 'Affiliation': 'Statistics Collaborative, Inc., Washington, DC.'}, {'ForeName': 'Zi-Fan', 'Initials': 'ZF', 'LastName': 'Yu', 'Affiliation': 'Statistics Collaborative, Inc., Washington, DC.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': 'Amylyx Pharmaceuticals, Inc., Cambridge, Massachusetts.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Klee', 'Affiliation': 'Amylyx Pharmaceuticals, Inc., Cambridge, Massachusetts.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Leslie', 'Affiliation': 'Amylyx Pharmaceuticals, Inc., Cambridge, Massachusetts.'}, {'ForeName': 'Rudolph E', 'Initials': 'RE', 'LastName': 'Tanzi', 'Affiliation': 'Sean M. Healey and AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Gilbert', 'Affiliation': 'Harvard University, Cambridge, Massachusetts.'}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'Yeramian', 'Affiliation': 'Amylyx Pharmaceuticals, Inc., Cambridge, Massachusetts.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schoenfeld', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Merit E', 'Initials': 'ME', 'LastName': 'Cudkowicz', 'Affiliation': 'Sean M. Healey and AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}]",Muscle & nerve,['10.1002/mus.27091']
2718,33059730,Equine-assisted biographical work (EABW) with individuals in the second half of life: study protocol of a multicentre randomised controlled trial.,"BACKGROUND


Equine-assisted therapy is more often practiced with children and adolescents than with the elderly, although individuals in the second half of life could also profit from it. This group, from the age of 50, is characterised by increasing emotional, social, health-related and cognitive changes; a critical life event, such as a neurological illness or loss of a family member, can increase the likelihood of subclinical depression. Individuals who exhibit depressive symptoms not necessarily diagnosed with a major depression may suffer from relevant losses of quality of life (e.g. sleep disorders, memory disorders, feelings of guilt, hopelessness). Despite the fact that the various healthcare systems are in general more frequently used, such individuals often do not receive adequate therapy. The processing of one's biography (reminiscence) is an elementary component of most psychotherapy approaches and has been demonstrated to treat and prevent the development of major depression. In this study, equine-assisted biographical work (EABW), a combination of equine-assisted therapy and biographical work, will be applied with individuals with subclinical depression in the second half of their life.
METHODS


This is a multicentre, prospective, randomised, controlled and open phase III study in enrolling participants with subclinical depression. The aim of the study is to evaluate whether a preventive, equine-assisted, age-specific treatment combining elements of equine-assisted intervention with those of biographical work offers better treatment potentials in comparison to a control group with no intervention. Study participants in the intervention group will receive weekly equine-assisted biographical work over a period of 8 weeks. The primary endpoint is the change in Beck Depression Inventory-II (BDI-II) in a pre-post comparison. Secondary endpoints include other health-related questionnaires including quality of life, reminiscence functions and anxiety.
DISCUSSION


The present study is the first randomised study examining the efficacy of biographical work with a horse and has the potential to establish an empirically based treatment for individuals in the second half of life and improving the symptoms of subclinical depression.
TRIAL REGISTRATION


German Clinical Trials Register DRKS00017010 . Registered on 01 April 2019.",2020,"This group, from the age of 50, is characterised by increasing emotional, social, health-related and cognitive changes; a critical life event, such as a neurological illness or loss of a family member, can increase the likelihood of subclinical depression.","['individuals in the second half of life', 'enrolling participants with subclinical depression', 'Individuals who exhibit depressive symptoms not necessarily diagnosed with a major depression', 'individuals with subclinical depression in the second half of their life']","['Equine-assisted biographical work (EABW', 'weekly equine-assisted biographical work']","['change in Beck Depression Inventory-II (BDI-II', 'health-related questionnaires including quality of life, reminiscence functions and anxiety']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0674992,"This group, from the age of 50, is characterised by increasing emotional, social, health-related and cognitive changes; a critical life event, such as a neurological illness or loss of a family member, can increase the likelihood of subclinical depression.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'Reittherapie Wittgenstein, Pulvermühle 3, 57319, Bad Berleburg, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wartenberg-Demand', 'Affiliation': ', Schrecksbach, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Forstmeier', 'Affiliation': 'Developmental Psychology and Clinical Psychology of the Lifespan, Faculty II, University of Siegen, Adolf-Reichwein-Str. 2a, 57068, Siegen, Germany. simon.forstmeier@uni-siegen.de.'}]",Trials,['10.1186/s13063-020-04784-3']
2719,33059741,"Implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in breast cancer post-treatment follow-up: a study protocol for a phase II randomised controlled trial (the EMINENT trial).","BACKGROUND


Due to advances in early detection and cancer treatment, 5-year relative survival rates for early breast cancer surpass 90% in developed nations. There is increasing focus on promotion of wellness in survivorship and active approaches to reducing morbidity related to treatment; however, current models of follow-up care are heavily reliant on hospital-based specialist-led care. This study aims to test the feasibility of the EMINENT intervention for implementing an integrated, shared-care model involving both cancer centre specialists and community-based general practitioners for early breast cancer post-treatment follow-up.
METHODS


We describe a protocol for a phase II, randomised controlled trial with two parallel arms and 1:1 allocation. A total of 60 patients with early-stage breast cancer will be randomised to usual, specialist-led, follow-up care (as determined by the treating surgeons, medical oncologists, and radiation oncologists) or shared follow-up care intervention (i.e. EMINENT). EMINENT is a nurse-enabled, pre-specified shared-care pathway with follow-up responsibilities divided between cancer centre specialists (i.e. surgeons and oncologists) and general practitioners. The primary outcome is health-related quality of life as measured by the Functional Assessment of Cancer Therapy-Breast Cancer. Secondary outcomes include patient experience, acceptance, and satisfaction of care; dietary, physical activity, and sedentary behaviours; financial toxicity; adherence; health resource utilisation; and adverse events.
DISCUSSION


The trial is designed to identify the barriers to implementing a shared-care model for breast cancer survivors following treatment. Results of this study will inform a definitive trial testing the effects of shared-care model on health-related quality of life of breast cancer survivors, as well as its ability to alleviate the growing demands on the healthcare system.
TRIAL REGISTRATION


Australia and New Zealand Clinical Trials Registry ACTRN12619001594112 . Registered on 19 November 2019.",2020,"This study aims to test the feasibility of the EMINENT intervention for implementing an integrated, shared-care model involving both cancer centre specialists and community-based general practitioners for early breast cancer post-treatment follow-up.
","['breast cancer survivors', '60 patients with early-stage breast cancer', 'cancer centre specialists and community-based general practitioners for early breast cancer post-treatment follow-up']",[],"['health-related quality of life as measured by the Functional Assessment of Cancer Therapy-Breast Cancer', 'patient experience, acceptance, and satisfaction of care; dietary, physical activity, and sedentary behaviours; financial toxicity; adherence; health resource utilisation; and adverse events']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.107727,"This study aims to test the feasibility of the EMINENT intervention for implementing an integrated, shared-care model involving both cancer centre specialists and community-based general practitioners for early breast cancer post-treatment follow-up.
","[{'ForeName': 'Raymond Javan', 'Initials': 'RJ', 'LastName': 'Chan', 'Affiliation': 'Division of Cancer Services, Proncess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. raymond.chan@qut.edu.au.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Emery', 'Affiliation': 'Department of General Practice and Centre for Cancer Research, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Cuff', 'Affiliation': 'Division of Cancer Services, Proncess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia.'}, {'ForeName': 'Laisa', 'Initials': 'L', 'LastName': 'Teleni', 'Affiliation': 'School of Nursing, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Simonsen', 'Affiliation': 'Division of Cancer Services, Proncess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': ""Faculty of Medicine, University of Queensland & Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Janda', 'Affiliation': 'Centre for Health Services Research, Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mckavanagh', 'Affiliation': 'Division of Cancer Services, Proncess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McKinnell', 'Affiliation': 'Division of Cancer Services, Proncess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Gosper', 'Affiliation': 'McGrath Foundation & Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia.'}, {'ForeName': 'Juanita', 'Initials': 'J', 'LastName': 'Ryan', 'Affiliation': 'Division of Surgery, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ria', 'Initials': 'R', 'LastName': 'Joseph', 'Affiliation': 'School of Nursing, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Crowe', 'Affiliation': 'Division of Cancer Services, Proncess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Harvey', 'Affiliation': 'Radiation Oncology Centre, Princess Alexandra Hospital, Metro South Health and University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'Pharmacy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Carrington', 'Affiliation': 'Pharmacy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Nund', 'Affiliation': 'School of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Crichton', 'Affiliation': 'School of Nursing, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McPhail', 'Affiliation': 'Australian Centre For Health Services Innovation (AusHSI), Queensland University of Technology, Brisbane, Queensland, Australia.'}]",Trials,['10.1186/s13063-020-04740-1']
2720,33059755,"Tailored, psychological intervention for anxiety and/or depression in people with chronic obstructive pulmonary disease (COPD), TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD): statistical analysis plan for a randomised controlled trial.","BACKGROUND


The aim of the TANDEM trial is to evaluate whether a tailored, psychological cognitive behavioural approach intervention, which links into, and optimises the effects of routine pulmonary rehabilitation (PR), leads to a reduction in mild/moderate anxiety and/or depression in people with moderate, severe or very severe chronic obstructive pulmonary disease.
METHODS AND DESIGN


TANDEM is a multi-centre, two-arm, parallel group, pragmatic, individually randomised controlled, superiority trial including an internal pilot. Participants are randomised to receive either the intervention (a tailored psychological intervention plus usual care including referral to PR) or the control (usual care including referral to PR). The designed randomisation ratio is 1.25:1 in favour of the intervention. The multiple-primary outcomes are participant depression and anxiety at 6 months, measured using the Hospital Anxiety and Depression Scale (HADS) depression and anxiety subscales.
RESULTS


This article describes the statistical analysis plan (SAP) for the TANDEM trial. In particular, we describe the general analysis principles, how we will handle missing data, the primary and secondary outcomes and how these will be analysed, sensitivity analyses for the multiple-primary outcomes, and any other analyses and data summaries. The SAP was developed and published prior to completion of follow-up of the last participant.
TRIAL REGISTRATION


ISRCTN registry ISRCTN59537391. Registered on 20 March 2017.",2020,Participants are randomised to receive either the intervention (a tailored psychological intervention plus usual care including referral to PR) or the control (usual care including referral to PR).,"['people with chronic obstructive pulmonary disease (COPD', 'people with moderate, severe or very severe chronic obstructive pulmonary disease']","['intervention (a tailored psychological intervention plus usual care including referral to PR) or the control (usual care including referral to PR', 'psychological intervention', 'routine pulmonary rehabilitation (PR']","['participant depression and anxiety at 6\u2009months, measured using the Hospital Anxiety and Depression Scale (HADS) depression and anxiety subscales']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}]",,0.140883,Participants are randomised to receive either the intervention (a tailored psychological intervention plus usual care including referral to PR) or the control (usual care including referral to PR).,"[{'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Chan', 'Affiliation': 'Institute of Population Health Sciences, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK. c.l.chan@qmul.ac.uk.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Smuk', 'Affiliation': 'London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Ratna', 'Initials': 'R', 'LastName': 'Sohanpal', 'Affiliation': 'Institute of Population Health Sciences, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Pinnock', 'Affiliation': 'Allergy and Respiratory Research Group, Usher Institute, The University of Edinburgh, Doorway 3, Medical School, Teviot Place, Edinburgh, EH8 9AG, UK.'}, {'ForeName': 'Stephanie J C', 'Initials': 'SJC', 'LastName': 'Taylor', 'Affiliation': 'Institute of Population Health Sciences, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04786-1']
2721,33059762,Engaging adolescents in changing behaviour (EACH-B): a study protocol for a cluster randomised controlled trial to improve dietary quality and physical activity.,"BACKGROUND


Poor diet and lack of physical activity are strongly linked to non-communicable disease risk, but modifying them is challenging. There is increasing recognition that adolescence is an important time to intervene; habits formed during this period tend to last, and physical and psychological changes during adolescence make it an important time to help individuals form healthier habits. Improving adolescents' health behaviours is important not only for their own health now and in adulthood, but also for the health of any future children. Building on LifeLab-an existing, purpose-built educational facility at the University of Southampton-we have developed a multi-component intervention for secondary school students called Engaging Adolescents in Changing Behaviour (EACH-B) that aims to motivate and support adolescents to eat better and be more physically active.
METHODS


A cluster randomised controlled trial is being conducted to evaluate the effectiveness of the EACH-B intervention. The primary outcomes of the intervention are self-reported dietary quality and objectively measured physical activity (PA) levels, both assessed at baseline and at 12-month follow-up. The EACH-B intervention consists of three linked elements: professional development for teachers including training in communication skills to support health behaviour change; the LifeLab educational module comprising in-school teaching of nine science lessons linked to the English National Curriculum and a practical day visit to the LifeLab facility; and a personalised digital intervention that involves social support and game features that promote eating better and being more active. Both the taught module and the LifeLab day are designed with a focus on the science behind the messages about positive health behaviours, such as diet and PA, for the adolescents now, in adulthood and their future offspring, with the aim of promoting personal plans for change. The EACH-B research trial aims to recruit approximately 2300 secondary school students aged 12-13 years from 50 schools (the clusters) from Hampshire and neighbouring counties. Participating schools will be randomised to either the control or intervention arm. The intervention will be run during two academic years, with continual recruitment of schools throughout the school year until the sample size is reached. The schools allocated to the control arm will receive normal schooling but will be offered the intervention after data collection for the trial is complete. An economic model will be developed to assess the cost-effectiveness of the EACH-B intervention compared with usual schooling.
DISCUSSION


Adolescents' health needs are often ignored and they can be difficult to engage in behaviour change. Building a cheap, sustainable way of engaging them in making healthier choices will benefit their long-term health and that of their future children.
TRIAL REGISTRATION


ISRCTN 74109264 . Registered on 30 August 2019. EACH-B is a cluster randomised controlled trial, funded by the National Institute for Health Research (RP-PG-0216-20004).",2020,"Improving adolescents' health behaviours is important not only for their own health now and in adulthood, but also for the health of any future children.",['2300 secondary school students aged 12-13\u2009years from 50 schools (the clusters) from Hampshire and neighbouring counties'],"['LifeLab educational module comprising in-school teaching of nine science lessons linked to the English National Curriculum and a practical day visit to the LifeLab facility; and a personalised digital intervention', 'EACH-B intervention', 'control arm will receive normal schooling']","['dietary quality and physical activity', 'self-reported dietary quality and objectively measured physical activity (PA) levels']","[{'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0324247', 'cui_str': 'Hampshire pig'}]","[{'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0828215,"Improving adolescents' health behaviours is important not only for their own health now and in adulthood, but also for the health of any future children.","[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Strömmer', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Millie', 'Initials': 'M', 'LastName': 'Barrett', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Woods-Townsend', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton, NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Baird', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrell', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton, NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Lord', 'Affiliation': 'Southampton Health Technology Assessments Centre, University of Southampton, Southampton, UK.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Morrison', 'Affiliation': 'Centre for Clinical and Community Applications of Health Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Shaw', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Vogel', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lawrence', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Lovelock', 'Affiliation': 'Southampton Education School, Faculty of Social Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bagust', 'Affiliation': 'Southampton Education School, Faculty of Social Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Varkonyi-Sepp', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton, NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Patsy', 'Initials': 'P', 'LastName': 'Coakley', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lyall', 'Initials': 'L', 'LastName': 'Campbell', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton, NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton, NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Horsfall', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Neelam', 'Initials': 'N', 'LastName': 'Kalita', 'Affiliation': 'Southampton Health Technology Assessments Centre, University of Southampton, Southampton, UK.'}, {'ForeName': 'Olu', 'Initials': 'O', 'LastName': 'Onyimadu', 'Affiliation': 'Southampton Health Technology Assessments Centre, University of Southampton, Southampton, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Clarke', 'Affiliation': 'Hampshire County Council, Winchester, UK.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Chase', 'Affiliation': 'Southampton City Council, Southampton, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Lambrick', 'Affiliation': 'School of Health Sciences, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hanson', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton, NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Godfrey', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton, NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Inskip', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Barker', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK. meb@mrc.soton.ac.uk.'}]",Trials,['10.1186/s13063-020-04761-w']
2722,33059828,Structural Deterioration of Transcatheter Versus Surgical Aortic Valve Bioprostheses in the PARTNER-2 Trial.,"BACKGROUND


It is unknown whether transcatheter valves will have similar durability as surgical bioprosthetic valves. Definitions of structural valve deterioration (SVD), based on valve related reintervention or death, underestimate the incidence of SVD.
OBJECTIVES


This study sought to determine and compare the 5-year incidence of SVD, using new standardized definitions based on echocardiographic follow-up of valve function, in intermediate-risk patients with severe aortic stenosis given transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) in the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial and registry.
METHODS


In the PARTNER 2A trial, patients were randomly assigned to receive either TAVR with the SAPIEN XT or SAVR, whereas in the SAPIEN 3 registry, patients were assigned to TAVR with the SAPIEN 3. The primary endpoint was the incidence of SVD, that is, the composite of SVD-related hemodynamic valve deterioration during echocardiographic follow-up and/or SVD-related bioprosthetic valve failure (BVF) at 5 years.
RESULTS


Compared with SAVR, the SAPIEN-XT TAVR cohort had a significantly higher 5-year exposure adjusted incidence rates (per 100 patient-years) of SVD (1.61 ± 0.24% vs. 0.63 ± 0.16%), SVD-related BVF (0.58 ± 0.14% vs. 0.12 ± 0.07%), and all-cause (structural or nonstructural) BVF (0.81 ± 0.16% vs. 0.27 ± 0.10%) (p ≤ 0.01 for all). The 5-year rates of SVD (0.68 ± 0.18% vs. 0.60 ± 0.17%; p = 0.71), SVD-related BVF (0.29 ± 0.12% vs. 0.14 ± 0.08%; p = 0.25), and all-cause BVF (0.60 ± 0.15% vs. 0.32 ± 0.11%; p = 0.32) in SAPIEN 3 TAVR were not significantly different to a propensity score matched SAVR cohort. The 5-year rates of SVD and SVD-related BVF were significantly lower in SAPIEN 3 versus SAPIEN XT TAVR matched cohorts.
CONCLUSIONS


Compared with SAVR, the second-generation SAPIEN XT balloon-expandable valve has a higher 5-year rate of SVD, whereas the third-generation SAPIEN 3 has a rate of SVD that was not different from SAVR. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII A [PARTNERII A]; NCT01314313; The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - PARTNERII - S3 Intermediate [PARTNERII S3i]; NCT03222128).",2020,"The 5-year rates of SVD and SVD-related BVF were significantly lower in SAPIEN 3 versus SAPIEN XT TAVR matched cohorts.
",['intermediate-risk patients with severe aortic stenosis given'],"['Aortic Transcatheter Valves', 'AoRTic TraNscathetER Valves - PII', 'Transcatheter Versus Surgical Aortic Valve Bioprostheses', 'TAVR with the SAPIEN XT or SAVR', 'transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR']","['5-year rates of SVD', 'TAVR', 'SVD-related BVF', '5-year rate of SVD', '5-year rates of SVD and SVD-related BVF', '5-year exposure adjusted incidence rates', 'incidence of SVD, that is, the composite of SVD-related hemodynamic valve deterioration during echocardiographic follow-up and/or SVD-related bioprosthetic valve failure (BVF']","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C2983694', 'cui_str': 'Personally Identifiable Information'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4285833', 'cui_str': 'Structural valve deterioration'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.0376653,"The 5-year rates of SVD and SVD-related BVF were significantly lower in SAPIEN 3 versus SAPIEN XT TAVR matched cohorts.
","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Pibarot', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart & Lung Institute, Laval University, Québec, Québec, Canada. Electronic address: Philippe.Pibarot@med.ulaval.ca.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Ternacle', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart & Lung Institute, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Wael A', 'Initials': 'WA', 'LastName': 'Jaber', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Erwan', 'Initials': 'E', 'LastName': 'Salaun', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart & Lung Institute, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Abdellaziz', 'Initials': 'A', 'LastName': 'Dahou', 'Affiliation': 'Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Federico M', 'Initials': 'FM', 'LastName': 'Asch', 'Affiliation': 'MedStar Health Research Institute at Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Weissman', 'Affiliation': 'MedStar Health Research Institute at Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Rodriguez', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Edwards Lifesciences, Irvine, California.'}, {'ForeName': 'Mohamed-Salah', 'Initials': 'MS', 'LastName': 'Annabi', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart & Lung Institute, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Ezequiel', 'Initials': 'E', 'LastName': 'Guzzetti', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart & Lung Institute, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Beaudoin', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart & Lung Institute, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Bernier', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart & Lung Institute, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Leipsic', 'Affiliation': ""St. Paul's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Blanke', 'Affiliation': ""St. Paul's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Marie-Annick', 'Initials': 'MA', 'LastName': 'Clavel', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart & Lung Institute, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Rogers', 'Affiliation': 'Edwards Lifesciences, Irvine, California.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Alu', 'Affiliation': 'Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Makkar', 'Affiliation': 'Cedars-Sinai Heart Institute, Los Angeles, California.'}, {'ForeName': 'D Craig', 'Initials': 'DC', 'LastName': 'Miller', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Samir R', 'Initials': 'SR', 'LastName': 'Kapadia', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mack', 'Affiliation': 'Baylor Scott & White Healthcare, Plano, Texas.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Webb', 'Affiliation': ""St. Paul's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Susheel K', 'Initials': 'SK', 'LastName': 'Kodali', 'Affiliation': 'Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Smith', 'Affiliation': 'Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Howard C', 'Initials': 'HC', 'LastName': 'Herrmann', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Vinod H', 'Initials': 'VH', 'LastName': 'Thourani', 'Affiliation': 'Department of Cardiovascular Surgery, Piedmont Heart Institute, Atlanta, Georgia.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Rebecca T', 'Initials': 'RT', 'LastName': 'Hahn', 'Affiliation': 'Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.08.049']
2723,33059886,Lifestyle modifications alone or combined with hormonal contraceptives improve sexual dysfunction in women with polycystic ovary syndrome.,"OBJECTIVE


To describe the prevalence of female sexual dysfunction in a well-defined polycystic ovary syndrome (PCOS) population, and to assess the impact of common PCOS treatments on sexual function.
DESIGN


Secondary analysis of a randomized controlled trial, oral contraceptive pills and weight loss in PCOS.
SETTING


Two academic medical centers.
PATIENTS


Women with PCOS (N = 114) defined by the Rotterdam criteria.
INTERVENTIONS


Continuous oral contraceptive pill (OCP) or intensive lifestyle modification (Lifestyle) or the combination (Combined) for 16 weeks.
MAIN OUTCOME MEASURES


Change in Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R) scores after 16 weeks.
RESULTS


There was no change in total FSFI or FSDS-R score in any treatment group; however, an increase in the FSFI desire domain subscore was observed in the Lifestyle and Combined treatments, indicating improved sexual desire over the 16-week period. Overall, 33 participants (28.9%) met criteria for sexual dysfunction by FSFI criteria (baseline score ≤26.55). Among this group, FSFI score improved after 16 weeks of Lifestyle and Combined treatments. There was no change in prevalence of sexual dysfunction in treatment groups at 16 weeks. Use of OCPs did not alter FSFI scores.
CONCLUSION(S)


Female sexual dysfunction is highly prevalent among women with PCOS. Our findings suggest that common treatments for PCOS, including intensive lifestyle modification and the combination of intensive lifestyle modification and OCPs, have the potential to improve sexual function in these women; the mechanism for these improvements is likely multifactorial.
CLINICAL TRIAL REGISTRATION NUMBER


NCT00704912.",2020,"There was no change in total FSFI or FSDS-R score in any treatment group; however, an increase in the FSFI desire domain subscore was observed in the Lifestyle and Combined treatments, indicating improved sexual desire over the 16-week period.","['women with polycystic ovary syndrome', 'Women with PCOS (N = 114) defined by the Rotterdam criteria', 'Two academic medical centers', '33 participants (28.9%) met criteria for sexual dysfunction by FSFI criteria (baseline score ≤26.55', 'women with PCOS']","['oral contraceptive pills', 'OCPs', 'Continuous oral contraceptive pill (OCP) or intensive lifestyle modification (Lifestyle) or the combination (Combined) for 16 weeks', 'Lifestyle modifications alone or combined with hormonal contraceptives']","['prevalence of sexual dysfunction', 'FSFI scores', 'Change in Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R) scores', 'total FSFI or FSDS-R score', 'Female sexual dysfunction', 'FSFI score', 'FSFI desire domain subscore', 'sexual function', 'sexual desire', 'sexual dysfunction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1112442', 'cui_str': 'Female sexual dysfunction'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0023618', 'cui_str': 'Libido'}]",114.0,0.171257,"There was no change in total FSFI or FSDS-R score in any treatment group; however, an increase in the FSFI desire domain subscore was observed in the Lifestyle and Combined treatments, indicating improved sexual desire over the 16-week period.","[{'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Steinberg Weiss', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Andrea Hsu', 'Initials': 'AH', 'LastName': 'Roe', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Allison', 'Affiliation': 'Department of Psychology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Dodson', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, Penn State College of Health and Human Development, University Park, Pennsylvania.'}, {'ForeName': 'Allen R', 'Initials': 'AR', 'LastName': 'Kunselman', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Christy M', 'Initials': 'CM', 'LastName': 'Stetter', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Nancy I', 'Initials': 'NI', 'LastName': 'Williams', 'Affiliation': 'Department of Kinesiology, Penn State College of Health and Human Development, University Park, Pennsylvania.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Gnatuk', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Stepanie J', 'Initials': 'SJ', 'LastName': 'Estes', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Sarwer', 'Affiliation': 'Center for Obesity Research and Education, Temple University College of Public Health, Philadelphia, Pennsylvania.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Coutifaris', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, Pennsylvania; Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Dokras', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: adokras@pennmedicine.upenn.edu.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.08.1396']
2724,33059925,Wound drainage after proximal femoral nail antirotation (PFNA) fixation may negatively affect the patients with intertrochanteric fractures: A prospective randomized controlled trial.,"INTRODUCTION


The effect of using closed suction drainage system with the proximal femoral nail antirotation (PFNA) system fixation on outcomes in treating intertrochanteric fractures (ITFs) is still unknown. This prospective randomized controlled trial aimed to examine whether routine drainage is useful for PFNA fixation in ITFs.
METHODS


A total of 80 patients with acute ITFs were treated with closed or mini-open reduction with PFNA fixation at the National Cheng Kung University Hospital and 60 eligible patients were randomized for whether to receive suction drainage. In clinical outcomes, the visual analog scale (VAS), morphine equivalent dosage, injured thigh width, body temperature, wound condition and wound infection were measured on postoperative day 1, 2, 4, 10, and 90. In laboratory outcomes, we evaluated hemoglobin and hematocrit levels postoperatively at different time points. Blood transfusion and total blood loss (TBL) were measured by Mercuriali's formula in millimeter.
RESULTS


The results revealed that the amount of blood transfusion received by the drained group (543.3 mL) was more than that by the undrained group (367.8 mL; p = 0.0074), and similarly, TBL in the drained group (750.1 mL) was more than that in the undrained group (537.4 mL; p = 0.0067). Regarding clinical and laboratory outcomes, compared with the undrained group, the drained group had a higher VAS score on postoperative day 2 (p = 0.0216). No difference was observed between the 2 groups for morphine equivalent dosage, thigh swelling, wound infection and hematoma, hospitalization period, or total number of complications at every time point after index procedure.
CONCLUSIONS


Blood transfusion requirement and TBL were higher in the drained group than in the undrained group of PFNA fixation for ITFs. In addition, the closed drainage system may have manifested no short-term benefit for wound condition postoperatively.",2020,"No difference was observed between the 2 groups for morphine equivalent dosage, thigh swelling, wound infection and hematoma, hospitalization period, or total number of complications at every time point after index procedure.
","['patients with intertrochanteric fractures', '80 patients with acute ITFs', 'at the National Cheng Kung University Hospital and 60 eligible patients']","['suction drainage', 'Wound drainage after proximal femoral nail antirotation (PFNA) fixation', 'closed suction drainage system with the proximal femoral nail antirotation (PFNA) system fixation', 'closed or mini-open reduction with PFNA fixation']","['Blood transfusion and total blood loss (TBL', 'visual analog scale (VAS), morphine equivalent dosage, injured thigh width, body temperature, wound condition and wound infection', 'VAS score', 'blood transfusion', 'TBL', 'hemoglobin and hematocrit levels', 'morphine equivalent dosage, thigh swelling, wound infection and hematoma, hospitalization period, or total number of complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162385', 'cui_str': 'Intertrochanteric fracture'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",80.0,0.0854333,"No difference was observed between the 2 groups for morphine equivalent dosage, thigh swelling, wound infection and hematoma, hospitalization period, or total number of complications at every time point after index procedure.
","[{'ForeName': 'Hao-Ming', 'Initials': 'HM', 'LastName': 'Chang', 'Affiliation': 'Department of Orthopaedics, Tainan Municipal Hospital (Managed by Show Chwan Medical Care Corporation), Tainan, Taiwan; Department of Orthopaedics, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Skeleton Materials and Bio-compatibility Core Lab, Research Center of Clinical Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Wei-Yi', 'Initials': 'WY', 'LastName': 'Lu', 'Affiliation': 'Department of Orthopaedics, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Orthopaedics, Show Chwan Memorial Hospital, Changhua, Taiwan.'}, {'ForeName': 'Fa-Chuan', 'Initials': 'FC', 'LastName': 'Kuan', 'Affiliation': 'Department of Orthopaedics, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Orthopaedics, Show Chwan Memorial Hospital, Changhua, Taiwan; Department of Biomedical Engineering, National Cheng Kung University, Tainan, Taiwan; Division of Traumatology, National Cheng Kung University Medical Center, College of Medicine, Tainan, Taiwan.'}, {'ForeName': 'Wei-Ren', 'Initials': 'WR', 'LastName': 'Su', 'Affiliation': 'Department of Orthopaedics, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Skeleton Materials and Bio-compatibility Core Lab, Research Center of Clinical Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Pin-Ying', 'Initials': 'PY', 'LastName': 'Chen', 'Affiliation': 'Department of Statistics, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Pei-Fang', 'Initials': 'PF', 'LastName': 'Su', 'Affiliation': 'Department of Statistics, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Kai-Lan', 'Initials': 'KL', 'LastName': 'Hsu', 'Affiliation': 'Department of Orthopaedics, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Skeleton Materials and Bio-compatibility Core Lab, Research Center of Clinical Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Biomedical Engineering, National Cheng Kung University, Tainan, Taiwan; Division of Traumatology, National Cheng Kung University Medical Center, College of Medicine, Tainan, Taiwan. Electronic address: dulendulen@gmail.com.'}]",Injury,['10.1016/j.injury.2020.10.033']
2725,33059959,"HIV Care Cascade Among Adolescents in a ""Test and Treat"" Community-Based Intervention: HPTN 071 (PopART) for Youth Study.","PURPOSE


The PopART for Youth (P-ART-Y) study was nested within the HPTN 071 (PopART) trial, a three-arm community randomized trial in 21 communities in Zambia and South Africa. The P-ART-Y study evaluated the acceptability and uptake of a combination HIV prevention package among young people. We report on the HIV care cascade for adolescents aged 10-19 years from 14 communities receiving the full HIV prevention package in Zambia and South Africa.
METHODS


Adolescents were offered participation in the PopART intervention, which included universal home-based HIV testing, linkage to care, antiretroviral therapy (ART) adherence, and other services. Data were collected from September 2016 to December 2017, covering the third round (R3) of the intervention.
RESULTS


We enumerated (listed) 128,241 adolescents (Zambia: 95,295 and South Africa: 32,946). Of the adolescents offered HIV testing, 81.9% accepted in Zambia and 70.3% in South Africa. Knowledge of HIV status was higher among older adolescents and increased from 31.4% before R3 to 88.3% at the end of R3 in Zambia and from 28.3% to 79.5% in South Africa. Overall, there were 1,710 (1.9%) adolescents identified as living with HIV by the end of R3 (515 new diagnoses and 1,195 self-reported). Of the new diagnoses, 335 (65.0%) were girls aged 15-19 years. The median time to initiate ART was 5 months. ART coverage before and after R3 increased from 61.3% to 78.7% in Zambia and from 65.6% to 87.8% in South Africa, with boys having higher uptake than girls in both countries.
CONCLUSIONS


The PopART intervention substantially increased coverage toward the first and second UNAIDS 90-90-90 targets in adolescents.",2020,Knowledge of HIV status was higher among older adolescents and increased from 31.4% before R3 to 88.3% at the end of R3 in Zambia and from 28.3% to 79.5% in South Africa.,"['young people', 'Adolescents', 'Youth (P-ART-Y) study was nested within the HPTN 071 (PopART) trial, a three-arm community randomized trial in 21 communities in Zambia and South Africa', '128,241 adolescents (Zambia: 95,295 and South Africa: 32,946', 'adolescents aged 10-19 years from 14 communities receiving the full HIV prevention package in Zambia and South Africa', 'Of the new diagnoses, 335 (65.0%) were girls aged 15-19 years']","['PopART intervention, which included universal home-based HIV testing, linkage to care, antiretroviral therapy (ART) adherence, and other services', 'combination HIV prevention package', 'PopART intervention']","['ART coverage', 'median time to initiate ART', 'Knowledge of HIV status', 'HIV Care Cascade']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",128241.0,0.0512208,Knowledge of HIV status was higher among older adolescents and increased from 31.4% before R3 to 88.3% at the end of R3 in Zambia and from 28.3% to 79.5% in South Africa.,"[{'ForeName': 'Kwame', 'Initials': 'K', 'LastName': 'Shanaube', 'Affiliation': 'Zambart, Lusaka, Zambia. Electronic address: kshanaube@zambart.org.zm.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Macleod', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Mwate Joseph', 'Initials': 'MJ', 'LastName': 'Chaila', 'Affiliation': 'Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Mackworth-Young', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Hoddinott', 'Affiliation': 'Desmond Tutu TB Centre, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Ab', 'Initials': 'A', 'LastName': 'Schaap', 'Affiliation': 'Zambart, Lusaka, Zambia; Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Floyd', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bock', 'Affiliation': 'Desmond Tutu TB Centre, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fidler', 'Affiliation': 'Faculty of Medicine, Department of Infectious Disease, Imperial College, London, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ayles', 'Affiliation': 'Zambart, Lusaka, Zambia; Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.07.029']
2726,33059980,Effects of one month of Common Yoga Protocol practice appear to be mediated by the angiogenic and neurogenic pathway: A pilot study.,"OBJECTIVE


To examine the molecular effects of mindful activities such as yoga and meditation DESIGN: This was an open label single arm exploratory yoga intervention study.
STUDY PARTICIPANTS


64 healthy individuals within the age of 18-60 years were recruited for this one month yoga intervention study.
INTERVENTION


Common Yoga Protocol (CYP) is a standardized yoga protocol released by Ministry of AYUSH, India for International Yoga Day. It includes all aspects of yoga i.e. asanas, pranayama and meditation. It is designed for adoption by all age groups for the health of community.
OUTCOME MEASURES


The participants were assessed for biochemical parameters including Fasting Sugar and Lipid profile. The molecular markers of neurogenesis (i.e. Brain derived Neurotropic Factor, BDNF) and Angiogenesis (i.e. Vascular Endothelial Growth Factor, VEGF and Angiogenin) along with Amyloid β (marker related to neuro-degenerative diseases) were assessed. All the assessments were made at baseline and after one month of the intervention.
RESULTS


After one month of CYP practice High Density Lipoprotein (HDL) levels increased significantly (p<0.001), although other biochemical parameters i.e. fasting sugar and other lipid assessments were found to be unaltered. Angiogenesis marker, angiogenin was increased significantly (p<0.002), other angiogenesis marker VEGF did not show any change along with BDNF, marker of neurogenesis. Amyloid β levels were also unaltered. Even though individual levels of VEGF and Amyloid β did not show any change, proportion of VEGF to Amyloid β showed a significant increase (p<0.001) after one month of CYP intervention indicating that the change in VEGF levels was significantly higher than the change in Amyloid β levels.
CONCLUSION


CYP practice may influence cell survival pathways mediated by angiogenic and neurogenic cross talk. Hence, CYP can be considered as a preventive measure for diseases associated with impaired angiogenic and neurogenic mechanism. This is the first study to examine the effects of CYP at the molecular level.",2020,"After one month of CYP practice High Density Lipoprotein (HDL) levels increased significantly (p<0.001), although other biochemical parameters i.e. fasting sugar and other lipid assessments were found to be unaltered.",['64 healthy individuals within the age of 18-60 years'],"['CYP practice', 'Common Yoga Protocol (CYP']","['angiogenesis marker VEGF', 'Amyloid β levels', 'Fasting Sugar and Lipid profile', 'Density Lipoprotein (HDL) levels', 'VEGF levels', 'Angiogenesis marker, angiogenin']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0051844', 'cui_str': 'Angiogenin'}]",64.0,0.0252281,"After one month of CYP practice High Density Lipoprotein (HDL) levels increased significantly (p<0.001), although other biochemical parameters i.e. fasting sugar and other lipid assessments were found to be unaltered.","[{'ForeName': 'Kanupriya', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': 'Neuroscience Research Lab, Department of Neurology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Viraaj', 'Initials': 'V', 'LastName': 'Pannu', 'Affiliation': 'Government Medical College and Hospital, Sector-32, Chandigarh, India.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Sayal', 'Affiliation': 'Neuroscience Research Lab, Department of Neurology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bhalla', 'Affiliation': 'Department of Internal Medicine,, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'Neuroscience Research Lab, Department of Neurology, Post Graduate Institute of Medical Education and Research, Chandigarh, India. Electronic address: akshay1anand@rediffmail.com.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.09.007']
2727,33063461,Effect of low level laser therapy on crestal bone levels around dental implants-A pilot study.,"BACKGROUND


Implant success is affected by initial bone resorption at the implant surface. Continuous efforts have been made to reduce the peri-implant crestal bone loss. Limited information is available regarding the influence of low level laser therapy (LLLT) on interaction between the bone and implant surface.
PURPOSE


The aim of this pilot study was to assess the effect of LLLT on peri-implant crestal bone levels.
MATERIALS AND METHODS


Twenty implants were placed in 20 patients who were randomly assigned to two groups. Group I patients' received no adjunctive treatment and group II patients' were administered LLLT using 980 nm diode laser at 0.1 W output power following implant placement. The energy density of 4 J/cm 2  was delivered at six sites for a duration of 10 seconds per site. Crestal bone levels were evaluated primarily using digital intraoral periapical (IOPA) radiograph. The measurements were made immediately (T0) and 6 weeks (T1) post implant placement; and 6 months (T2) and 1 year (T3) post prosthetic loading time intervals and compared using repeated measures ANOVA test.
RESULTS


Crestal bone levels at baseline were statistically not significant between groups (P = .880). At T3 time interval, the mean change in crestal bone levels around all anatomical implant sites measured was 0.81 (SE 0.04) mm for irradiated group and 0.97 (SE 0.04) mm for nonirradiated group. Intergroup analysis revealed statistically significant (P = .020) less crestal bone loss in group that received LLLT.
CONCLUSION


Under the conditions of this study, LLLT reduced the crestal bone resorption surrounding dental implants.
TRIAL REGISTRATION


The present clinical trial was not registered.",2020,"Intergroup analysis revealed statistically significant (P = .020) less crestal bone loss in group that received LLLT.
",['Twenty implants were placed in 20 patients who were randomly assigned to two groups'],"['LLLT', ""no adjunctive treatment and group II patients' were administered LLLT using 980\u2009nm diode laser at 0.1 W output power following implant placement"", 'low level laser therapy (LLLT', 'low level laser therapy']","['Crestal bone levels', 'crestal bone levels', 'crestal bone loss', 'crestal bone resorption']","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}]",20.0,0.16785,"Intergroup analysis revealed statistically significant (P = .020) less crestal bone loss in group that received LLLT.
","[{'ForeName': 'Prachi', 'Initials': 'P', 'LastName': 'Gulati', 'Affiliation': 'Department of Prosthodontics, I.T.S. Centre for Dental Studies and Research, Ghaziabad, Uttar Pradesh, India.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Department of Prosthodontics, I.T.S. Centre for Dental Studies and Research, Ghaziabad, Uttar Pradesh, India.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Issar', 'Affiliation': 'Department of Prosthodontics, I.T.S. Centre for Dental Studies and Research, Ghaziabad, Uttar Pradesh, India.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Thakral', 'Affiliation': 'Oral and Maxillofacial Surgeon, Military Dental Centre, New Delhi, India.'}]",Clinical implant dentistry and related research,['10.1111/cid.12957']
2728,33063705,"Exploring the safety and effectiveness of subcutaneous autologous serum therapy versus conventional intramuscular autologous serum therapy in chronic urticaria: An observer-blind, randomized, controlled study.","Background


Autologous serum therapy aims to supplement the existing pharmacotherapy in chronic urticaria by decreasing the antihistamine pill-burden and maintaining symptom-free interval. Subcutaneous autologous serum therapy further modifies the amount of serum (2 mL to 1 mL) and gauge of a needle (24G to 31G) to improve compliance and facilitate ease of application.
Objectives


To assess clinical effectiveness and safety of subcutaneous autologous serum therapy versus conventional intramuscular autologous serum therapy and to compare the quality of life in the two treatment arms.
Methods


Institution-based, assessor-blind, prospective, randomized, parallel-group, active-controlled trial with 32 patients in each treatment arm and analyzed on a modified intention to treat principle. After baseline autologous serum skin test, autologous serum was injected as per randomization every week for 9 consecutive weeks.
Results


Among the study population, conventional intramuscular autologous serum therapy and subcutaneous autologous serum therapy had a comparable duration of disease (P = 0.164, Mann-Whitney U test), autoreactive status (P = 0.796), urticaria total severity score (P = 0.637) and urticaria activity score summed up over 7 days (P = 0.982). Both urticaria activity score summed up over 7 days and total severity score along with antihistamine pill-burden reduced significantly (P < 0.001, Friedman's analysis of variance) in both subcutaneous autologous serum therapy and conventional intramuscular autologous serum therapy from first follow-up onwards (P < 0.05, Post hoc Dunn's test). Significant improvement was noted in patient's as well as physician's global assessment of disease activity improvement scale (P < 0.001, Friedman's analysis of variance). Intergroup analysis showed that there was no significant difference in urticaria activity score summed up over 7 days either at baseline (P = 0.982, Mann-Whitney U test) or at study end (P = 0.398, Mann-Whitney U test). Similar comparable results were found in the total severity score at the end of the study (P = 0.345, Mann-Whitney U test). Dermatology life quality index showed marked improvement with both types of treatment (P < 0.0001, Wilcoxon test), and the intergroup comparison showed comparable dermatology life quality index values (P = 0.994, Mann-Whitney U test). The pain score at the injection site was more with conventional intramuscular autologous serum therapy than subcutaneous autologous serum therapy (P = 0.0115, Mann-Whitney test). Younger age and lower baseline total severity scores were associated with a better therapeutic response. Baseline urticaria activity score added up over a period of 7 days and total severity scores and the diameter of lesions showed a positive correlation with response pattern.
Limitation


Basophil histamine release assay not done. Logistics could not support follow-up beyond the end of treatment.
Conclusion


Subcutaneous autologous serum therapy is not inferior to conventional intramuscular autologous serum therapy with the additional advantage of less pain and operational feasibility.",2020,"Dermatology life quality index showed marked improvement with both types of treatment (P < 0.0001, Wilcoxon test), and the intergroup comparison showed comparable dermatology life quality index values (P = 0.994, Mann-Whitney U test).",['chronic urticaria'],"['conventional intramuscular autologous serum therapy and subcutaneous autologous serum therapy', 'subcutaneous autologous serum therapy', 'conventional intramuscular autologous serum therapy', 'Subcutaneous autologous serum therapy']","['total severity score', 'dermatology life quality index values', 'safety and effectiveness', 'Dermatology life quality index', 'Baseline urticaria activity score', 'total severity scores', 'duration of disease', 'autoreactive status', 'pain score', 'quality of life', 'urticaria activity score', ""physician's global assessment of disease activity improvement scale"", 'urticaria total severity score']","[{'cui': 'C0263338', 'cui_str': 'Chronic urticaria'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0242348', 'cui_str': 'Serotherapy'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",32.0,0.0238133,"Dermatology life quality index showed marked improvement with both types of treatment (P < 0.0001, Wilcoxon test), and the intergroup comparison showed comparable dermatology life quality index values (P = 0.994, Mann-Whitney U test).","[{'ForeName': 'Adrija', 'Initials': 'A', 'LastName': 'Datta', 'Affiliation': 'Department of Dermatology, Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Somodyuti', 'Initials': 'S', 'LastName': 'Chandra', 'Affiliation': 'Department of Dermatology, Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Abanti', 'Initials': 'A', 'LastName': 'Saha', 'Affiliation': 'Department of Dermatology, Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Sil', 'Affiliation': 'Department of Pharmacology, Rampurhat Government Medical College, Rampurhat, West Bengal, India.'}, {'ForeName': 'Nilay Kanti', 'Initials': 'NK', 'LastName': 'Das', 'Affiliation': 'Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India.'}]","Indian journal of dermatology, venereology and leprology",['10.4103/ijdvl.IJDVL_577_19']
2729,33063732,Neuroimaging mechanisms of high-frequency repetitive transcranial magnetic stimulation for treatment of amnestic mild cognitive impairment: a double-blind randomized sham-controlled trial.,"Individuals with amnestic mild cognitive impairment (aMCI) have a high risk of developing Alzheimer's disease. Although repetitive transcranial magnetic stimulation (rTMS) is considered a potentially effective treatment for cognitive impairment in patients with aMCI, the neuroimaging mechanisms are poorly understood. Therefore, we performed a double-blind randomized sham-controlled trial in which rTMS was applied to the left dorsolateral prefrontal cortex of aMCI patients recruited from a community near the Third Hospital Affiliated to Sun Yat-sen University, China. Twenty-four patients with aMCI were randomly assigned to receive true rTMS (treatment group, n = 12, 6 men and 6 women; age 65.08 ± 4.89 years) or sham stimulation (sham group, n = 12, 5 men and 7 women; age 64.67 ± 4.77 years). rTMS parameters included a stimulation frequency of 10 Hz, stimulation duration of 2 seconds, stimulation interval of 8 seconds, 20 repetitions at 80% of the motor threshold, and 400 pulses per session. rTMS/sham stimulation was performed five times per week over a period of 4 consecutive weeks. Our results showed that compared with baseline, Montreal Cognitive Assessment scores were significantly increased and the value of the amplitude of low-frequency fluctuation (ALFF) was significantly increased at the end of treatment and 1 month after treatment. Compared with the sham group, the ALFF values in the right inferior frontal gyrus, triangular part of the inferior frontal gyrus, right precuneus, left angular gyrus, and right supramarginal gyrus were significantly increased, and the ALFF values in the right superior frontal gyrus were significantly decreased in the treatment group. These findings suggest that high-frequency rTMS can effectively improve cognitive function in aMCI patients and alter spontaneous brain activity in cognitive-related brain areas. This study was approved by the Ethics Committee of Shenzhen Baoan Hospital of Southern Medical University, China (approval No. BYL20190901) on September 3, 2019, and registered in the Chinese Clinical Trials Registry (registration No. ChiCTR1900028180) on December 14, 2019.",2021,"Compared with the sham group, the ALFF values in the right inferior frontal gyrus, triangular part of the inferior frontal gyrus, right precuneus, left angular gyrus, and right supramarginal gyrus were significantly increased, and the ALFF values in the right superior frontal gyrus were significantly decreased in the treatment group.","['amnestic mild cognitive impairment', 'treatment group, n = 12, 6 men and 6 women; age 65.08 ± 4.89 years) or sham stimulation (sham group, n = 12, 5 men and 7 women; age 64.67 ± 4.77 years', 'Twenty-four patients with aMCI', 'Individuals with amnestic mild cognitive impairment (aMCI', 'Shenzhen Baoan Hospital of Southern Medical University, China (approval No. BYL20190901) on September 3, 2019, and registered in the Chinese Clinical Trials Registry (registration', 'patients with aMCI', 'aMCI patients recruited from a community near the Third Hospital Affiliated to Sun Yat-sen University, China']","['repetitive transcranial magnetic stimulation (rTMS', 'rTMS/sham stimulation', 'high-frequency repetitive transcranial magnetic stimulation', 'rTMS', 'true rTMS']","['ALFF values', 'cognitive function', 'amplitude of low-frequency fluctuation (ALFF', 'ALFF values in the right inferior frontal gyrus, triangular part of the inferior frontal gyrus, right precuneus, left angular gyrus, and right supramarginal gyrus', 'stimulation frequency of 10 Hz, stimulation duration of 2 seconds, stimulation interval of 8 seconds, 20 repetitions', 'Montreal Cognitive Assessment scores']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0205238', 'cui_str': 'True'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0152298', 'cui_str': 'Structure of inferior frontal gyrus'}, {'cui': 'C0262350', 'cui_str': 'Pars Triangulari'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0152305', 'cui_str': 'Structure of angular gyrus'}, {'cui': 'C0228214', 'cui_str': 'Structure of supramarginal gyrus'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}]",24.0,0.192484,"Compared with the sham group, the ALFF values in the right inferior frontal gyrus, triangular part of the inferior frontal gyrus, right precuneus, left angular gyrus, and right supramarginal gyrus were significantly increased, and the ALFF values in the right superior frontal gyrus were significantly decreased in the treatment group.","[{'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Yuan', 'Affiliation': 'Department of Rehabilitation Medicine and Physiotherapy, Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zeng', 'Affiliation': 'Department of Rehabilitation Medicine and Physiotherapy, Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine and Physiotherapy, Shenzhen Baoan Hospital of Southern Medical University, Shenzhen, Guangdong Province, China.'}, {'ForeName': 'Xiu-Yun', 'Initials': 'XY', 'LastName': 'Wen', 'Affiliation': 'Department of Rehabilitation Medicine and Physiotherapy, Shenzhen Baoan Hospital of Southern Medical University, Shenzhen, Guangdong Province, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Rehabilitation Medicine and Physiotherapy, Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'Department of Rehabilitation Medicine and Physiotherapy, Shenzhen Baoan Hospital of Southern Medical University, Shenzhen, Guangdong Province, China.'}, {'ForeName': 'Shang-Jie', 'Initials': 'SJ', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine and Physiotherapy, Shenzhen Baoan Hospital of Southern Medical University, Shenzhen, Guangdong Province, China.'}, {'ForeName': 'Guo-Zhi', 'Initials': 'GZ', 'LastName': 'Huang', 'Affiliation': 'Department of Rehabilitation Medicine and Physiotherapy, Zhujiang Hospital of Southern Medical University; Rehabilitation School of Southern Medical University, Guangzhou, Guangdong Province, China.'}]",Neural regeneration research,['10.4103/1673-5374.295345']
2730,33063780,Illness Uncertainty and Its Antecedents for Patients With Prostate Cancer and Their Partners.,"OBJECTIVES


Guided by Mishel's uncertainty in illness theory, patterns of change in uncertainty were explored over time for patients with prostate cancer and their partners. In addition, the relationships between uncertainty and its antecedents were examined, and the role effects (patient versus partner) on these relationships were assessed.
SAMPLE &AMP; SETTING


This study is a secondary analysis of the longitudinal data collected from a randomized clinical trial.
METHODS &AMP; VARIABLES


The current authors fitted multiple-level models that included time-invariant baseline variables (sociodemographics and cancer factors) and time-varying variables (uncertainty, symptoms, and social support) measured at baseline and at 4, 8, and 12 months thereafter.
RESULTS


No statistically significant patterns of change in uncertainty over time were detected. Partners reported greater uncertainty than patients. Higher uncertainty was associated with more general and prostate cancer-specific symptoms, recurrent and advanced prostate cancer, higher prostate-specific antigen level, and lower social support. More urinary symptoms were associated with greater uncertainty in patients than in partners.
IMPLICATIONS FOR NURSING


Uncertainty management can be tailored for and target symptom management and social support.
",2020,"Higher uncertainty was associated with more general and prostate cancer-specific symptoms, recurrent and advanced prostate cancer, higher prostate-specific antigen level, and lower social support.","['AMP', 'patients with prostate cancer and their partners', 'Patients With Prostate Cancer and Their Partners']",['SAMPLE &AMP'],"['general and prostate cancer-specific symptoms, recurrent and advanced prostate cancer, higher prostate-specific antigen level', 'time-invariant baseline variables (sociodemographics and cancer factors) and time-varying variables (uncertainty, symptoms, and social support', 'urinary symptoms']","[{'cui': 'C0001465', 'cui_str': 'Adenosine phosphate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001465', 'cui_str': 'Adenosine phosphate'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}]",,0.0240606,"Higher uncertainty was associated with more general and prostate cancer-specific symptoms, recurrent and advanced prostate cancer, higher prostate-specific antigen level, and lower social support.","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Guan', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Peiran', 'Initials': 'P', 'LastName': 'Guo', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Judge Santacroce', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Ding-Geng', 'Initials': 'DG', 'LastName': 'Chen', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'University of North Carolina.'}]",Oncology nursing forum,['10.1188/20.ONF.721-731']
2731,33063789,Association Between Physical Activity Levels and Chemotherapy-Induced Peripheral Neuropathy Severity in Cancer Survivors.,"OBJECTIVES


To evaluate for differences in demographic and clinical characteristics, as well as subjective and objective measures of chemotherapy-induced peripheral neuropathy (CIPN), among different exercise groups.
SAMPLE &AMP; SETTING


Cancer survivors (N = 290) were recruited from throughout the San Francisco Bay Area.
METHODS &AMP; VARIABLES


Based on the recommended 150 minutes or more of exercise per week, survivors were classified into the no exercise (NoEx), less exercise (LessEx), or recommended exercise (RecEx) group. Survivors completed self-report questionnaires and underwent sensory and balance testing.
RESULTS


Compared to the RecEx group, survivors in the NoEx group had less education, were less likely to be married/partnered, had a lower household income, had a higher level of comorbidity, and had poorer functional status. No differences were found among the groups in CIPN duration; pain intensity scores; or changes in light touch, cold, and pain sensations.
IMPLICATIONS FOR NURSING


Clinicians can recommend walking as a therapeutic option for survivors with CIPN and refer them to physical therapy.
",2020,"No differences were found among the groups in CIPN duration; pain intensity scores; or changes in light touch, cold, and pain sensations.
","['Cancer Survivors', 'Cancer survivors (N = 290) were recruited from throughout the San Francisco Bay Area']","['RecEx', 'no exercise (NoEx), less exercise (LessEx), or recommended exercise (RecEx) group']","['CIPN duration; pain intensity scores; or changes in light touch, cold, and pain sensations']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0423553', 'cui_str': 'Light touch'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",290.0,0.0213867,"No differences were found among the groups in CIPN duration; pain intensity scores; or changes in light touch, cold, and pain sensations.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wilcoxon', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Kord M', 'Initials': 'KM', 'LastName': 'Kober', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Viele', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Topp', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Smoot', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Abrams', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Chesney', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Paul', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Yvette P', 'Initials': 'YP', 'LastName': 'Conley', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Jon D', 'Initials': 'JD', 'LastName': 'Levine', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Miaskowski', 'Affiliation': 'University of California, San Francisco.'}]",Oncology nursing forum,['10.1188/20.ONF.703-719']
2732,33063921,"""It felt very special, it felt customised to me""-A qualitative investigation of the experiences of participating in a clinical trial of CBT for young people at risk of bipolar disorder.","OBJECTIVES


The Bipolar at Risk Trial (BART) was a feasibility randomized controlled trial investigating cognitive behavioral therapy (CBT) compared with treatment as usual (TAU) in young people at high risk of developing bipolar disorder (BD). This qualitative study aimed to investigate participants' experiences of trial involvement, and the acceptability of CBT for this population.
DESIGN


Participants were those identified as being at risk of bipolar disorder, determined by current symptoms or family history. A purposive sample of twenty-one participants from both the intervention and TAU arms of the trial was recruited.
METHODS


Twenty-one semi-structured interviews were conducted by service user researchers (13 participants had received therapy and 8 TAU). Interviews were audio recorded with consent from participants and transcribed verbatim. NVivo 11 Pro software was used to conduct an inductive thematic analysis.
RESULTS


Super-ordinate themes were ""adaptability and flexibility,"" ""feeling understood and valued,"" and ""relevance of study and intervention"" which had two sub-themes-""value of the trial therapy"" and ""acceptability of trial processes."" Participating in the trial and having therapy enabled participants to feel understood and valued by research assistants (RAs) and therapists. Participants viewed therapy as relevant to their current concerns and valued adaptability and flexibility of RAs and therapists.
CONCLUSIONS


Findings highlight the importance and value of flexibility, adaptability, and understanding in relationships between participants and trial staff. Findings also indicate that the trial processes and CBT focusing on mood swings are acceptable and relevant to participants from this at risk population.
PRACTITIONER POINTS


Young people at risk of bipolar disorder value a flexible approach to assessments and therapy, developing a rapport with research assistants and therapists and opening up to them when they feel comfortable to do so. CBT focusing on coping with mood swings was acceptable to the majority of participants who received it and it was perceived as helpful in ways that were personal to each participant.",2020,CBT focusing on coping with mood swings was acceptable to the majority of participants who received it and it was perceived as helpful in ways that were personal to each participant.,"['Participants were those identified as being at risk of bipolar disorder, determined by current symptoms or family history', 'young people at high risk of developing bipolar disorder (BD', 'young people at risk of bipolar disorder', 'Twenty-one semi-structured interviews were conducted by service user researchers (13 participants had received therapy and 8 TAU', 'A purposive sample of twenty-one participants from both the intervention and TAU arms of the trial was recruited']","['CBT', 'cognitive behavioral therapy (CBT', 'usual (TAU']","['adaptability and flexibility,"" ""feeling understood and valued,"" and ""relevance']","[{'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0241889', 'cui_str': 'Family history of clinical finding'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",21.0,0.0860395,CBT focusing on coping with mood swings was acceptable to the majority of participants who received it and it was perceived as helpful in ways that were personal to each participant.,"[{'ForeName': 'Wendy Theresa', 'Initials': 'WT', 'LastName': 'Jones', 'Affiliation': 'The Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, UK.'}, {'ForeName': 'Rory Edward', 'Initials': 'RE', 'LastName': 'Byrne', 'Affiliation': 'The Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shiers', 'Affiliation': 'The Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Law', 'Affiliation': 'The Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Parker', 'Affiliation': 'The Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, UK.'}]",Psychology and psychotherapy,['10.1111/papt.12313']
2733,33063932,A randomized controlled trial of a structured exercise intervention after the completion of acute cancer treatment in adolescents and young adults.,"BACKGROUND


Cancer treatments are frequently associated with impaired physical fitness, quality of life (QOL), and fatigue, often persisting into survivorship.  Studies in older adults with cancer have demonstrated benefits from exercise; however, this has not been rigorously investigated in adolescents and young adults (AYA). The aim of this study was to determine whether a structured 10-week exercise intervention was associated with improved cardiorespiratory fitness (VO 2peak  ), fatigue, and QOL in AYA who have recently completed cancer treatment.
METHOD


Forty-three AYA (median age 21 ± 6 years) were randomly assigned to an exercise group (n = 22) or a control group (n = 21). The exercise group received a structured 10-week exercise program comprising progressive aerobic and resistance exercise; the control arm received routine care. VO 2peak  was measured at baseline, 10 weeks, and six months. Fatigue and QOL were assessed by the FACIT fatigue scale and the PEDS QL, respectively.
RESULTS


Mean VO 2peak  at baseline was 26.5 ± 7.2 mL.kg -1  .min -1  , which is substantially lower than population norms. The exercise group demonstrated significant improvement in VO 2peak  at 10 weeks compared with controls (33.8 ± 8.1 vs 29.6 ± 7.6 mL.kg -1  .min -1  , P = 0.0002), but by six months, the difference was no longer significant (32.9 ± 7.0 vs 30.9 ± 11.0 mL.kg -1  .min -1  , P = 0.21). There were no significant differences in fatigue or total QOL scores between groups.
CONCLUSION


Cancer treatment is associated with reduced VO 2peak  in AYA. Improvement in VO 2peak  was accelerated by a 10-week exercise program; however, no significant benefit was observed in QOL or fatigue. The plateau in VO 2peak  at six months suggests that a maintenance exercise program may be beneficial.",2020,"There were no significant differences in fatigue or total QOL scores between groups.
","['Forty-three AYA (median age 21 ± 6 years', 'adolescents and young adults', 'adolescents and young adults (AYA', 'older adults with cancer']","['exercise group', 'structured exercise intervention', 'structured 10-week exercise program comprising progressive aerobic and resistance exercise; the control arm received routine care', 'structured 10-week exercise intervention']","['QOL or fatigue', 'FACIT fatigue scale', 'fatigue or total QOL scores', 'Fatigue and QOL', 'cardiorespiratory fitness (VO 2peak  ), fatigue, and QOL', 'Mean VO', 'physical fitness, quality of life (QOL), and fatigue', 'VO 2peak']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",,0.0735769,"There were no significant differences in fatigue or total QOL scores between groups.
","[{'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Atkinson', 'Affiliation': 'Youth Cancer Service SA/NT, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Murnane', 'Affiliation': 'ONTrac at Peter Mac, Victorian Adolescent and Young Adult Cancer Service, Melbourne, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Goddard', 'Affiliation': ""Department of Haematology and Oncology, Women's and Children's Hospital, North Adelaide, Australia.""}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Pendergrast', 'Affiliation': ""Department of Haematology and Oncology, Women's and Children's Hospital, North Adelaide, Australia.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rogers', 'Affiliation': ""Department of Haematology and Oncology, Women's and Children's Hospital, North Adelaide, Australia.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Manudhane', 'Affiliation': ""Department of Haematology and Oncology, Women's and Children's Hospital, North Adelaide, Australia.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Osborn', 'Affiliation': 'Youth Cancer Service SA/NT, Royal Adelaide Hospital, Adelaide, Australia.'}]",Pediatric blood & cancer,['10.1002/pbc.28751']
2734,33063953,Acute beetroot juice supplementation improves exercise tolerance and cycling efficiency in adults with obesity.,"BACKGROUND


Exercise training improves health outcomes in individuals with obesity (IO); however, it remains challenging for IO to adhere to exercise. Thus, it is critical to identify novel strategies that improve exercise tolerance (ET) and adherence in IO. Beetroot juice (BRJ), high in inorganic dietary nitrate, consistently improves exercise performance in athletes, individuals with cardiopulmonary diseases, and nonobese lean individuals. These improvements may be explained by reduced oxygen uptake (VO 2  ) during exercise, enhanced blood flow, and greater mitochondrial efficiency. To date, we are aware of no studies that have compared the effects of BRJ, sodium nitrate (NaNO3), and nitrate-depleted BRJ (PLA) for improving ET and cardiometabolic health in IO.
PURPOSE


Determine if BRJ improves ET, exercise efficiency (EE), and cardiometabolic health in IO and identify possible mechanisms of action.
METHODS


Vascular hemodynamic, submaximal- and maximal-exercise VO 2  , and time to exhaustion (TTE) were assessed in 16 participants 2.5 hr following consumption of: 1) BRJ, 2) NaNO 3  , 3) PLA, or 4) CON.
RESULTS


A significant treatment effect was observed for submaximal exercise VO 2  (p = .003), and TTE (p < .001). Post hoc analyses revealed lower VO 2  during submaximal exercise in BRJ compared to PLA (p = .009) NaNO3 (p = .042) and CON (0.009), equating to an average improvement of ~ 7% with BRJ. TTE was greater for BRJ compared to other treatment arms, PLA (p = .008), NaNO3 (p = .038), and CON (p=<0.001), equating to ~ 15% improvement with BRJ. No significant changes were observed for other outcomes.
CONCLUSIONS


Consumption of BRJ improved EE during submaximal exercise by 7%, and TTE by 15% compared to other conditions. These results suggest that BRJ may improve EE and exercise tolerance in IO.",2020,"A significant treatment effect was observed for submaximal exercise VO 2  (p = .003), and TTE (p < .001).","['adults with obesity', 'athletes, individuals with cardiopulmonary diseases, and nonobese lean individuals', '16 participants 2.5\xa0hr following consumption of: 1) BRJ, 2) NaNO 3  , 3) PLA, or 4) CON', 'individuals with obesity (IO']","['Exercise training', 'Beetroot juice (BRJ), high in inorganic dietary nitrate', 'BRJ, sodium nitrate (NaNO3), and nitrate-depleted BRJ (PLA', 'Acute beetroot juice supplementation', 'BRJ']","['exercise tolerance and cycling efficiency', 'exercise tolerance (ET) and adherence', 'Vascular hemodynamic, submaximal- and maximal-exercise VO 2  , and time to exhaustion (TTE', 'oxygen uptake (VO 2  ) during exercise, enhanced blood flow, and greater mitochondrial efficiency', 'health outcomes', 'EE and exercise tolerance', 'NaNO3', 'ET, exercise efficiency (EE), and cardiometabolic health', 'submaximal exercise VO 2', 'exercise performance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0034072', 'cui_str': 'Cor pulmonale'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0074748', 'cui_str': 'sodium nitrate'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",16.0,0.0309602,"A significant treatment effect was observed for submaximal exercise VO 2  (p = .003), and TTE (p < .001).","[{'ForeName': 'Christian E', 'Initials': 'CE', 'LastName': 'Behrens', 'Affiliation': 'Department of Nutrition Sciences, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Khandaker', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': 'Department of Pathology and Center for Free Radical Biology, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Ricart', 'Affiliation': 'Department of Pathology and Center for Free Radical Biology, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Braxton', 'Initials': 'B', 'LastName': 'Linder', 'Affiliation': 'Department of Human Studies, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Fernández', 'Affiliation': 'Department of Nutrition Sciences, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Bertrand', 'Affiliation': 'Department of Nutrition Sciences, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Rakesh P', 'Initials': 'RP', 'LastName': 'Patel', 'Affiliation': 'Department of Pathology and Center for Free Radical Biology, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Fisher', 'Affiliation': 'Department of Human Studies, The University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Physiological reports,['10.14814/phy2.14574']
2735,33063959,[Transcanalicular balloon dacryoplasty for the treatment of post-dacryocystorhinostomy recurrent stenoses].,"PURPOSE


To compare the effectiveness of minimally invasive techniques used for the treatment of common canalicular (CC) ostium stenosis (or obliteration) in post-dacryocystorhinostomy (post-DCR) patients.
MATERIAL AND METHODS


The study included 121 patients (127 cases), of which 61 patients (64 cases) had stenosis of the CC ostium and 60 patients (63 cases) had CC ostium obliteration. All stenoses and obliterations were recurrent and developed 6 months to 5 years after primary endonasal endoscopic DCR. Patients were divided into 3 groups. Group 1 included 20 patients (20 cases) with stenosis and 21 patients (22 cases) with CC ostium obliteration who underwent transcanalicular balloon dacryoplasty (DCP), group 2 - 20 patients (21 cases) with stenosis and 20 patients (21 cases) with CC ostium obliteration who underwent transcanalicular DCP and bicanalicular intubation, and group 3 - 21 patients (23 cases) with stenosis and 19 patients (20 cases) with CC ostium obliteration who received bicanalicular intubation alone. Results were evaluated 12 months after the intervention.
RESULTS


The treatment was effective in as many as 80% and 68.2% of cases (respectively) in group 1, 76.2% and 66.7% of cases (respectively) in group 2, and 56.5% and 50% of cases (respectively) in group 3.
CONCLUSION


The study proves transcanalicular DCP effective alone and shows no need in potentially complicated lacrimal ducts intubation.",2020,All stenoses and obliterations were recurrent and developed 6 months to 5 years after primary endonasal endoscopic DCR.,"[' and group 3 - 21 patients (23 cases) with stenosis and 19 patients (20 cases) with', 'common canalicular (CC) ostium stenosis (or obliteration) in post-dacryocystorhinostomy (post-DCR) patients', '121 patients (127 cases), of which 61 patients (64 cases) had stenosis of the CC ostium and 60 patients (63 cases) had CC ostium obliteration', '20 patients (20 cases) with stenosis and 21 patients (22 cases) with', 'post-dacryocystorhinostomy recurrent stenoses', ' group 2 - 20 patients (21 cases) with stenosis and 20 patients (21 cases) with']","['CC ostium obliteration who received bicanalicular intubation alone', 'CC ostium obliteration who underwent transcanalicular balloon dacryoplasty (DCP', 'CC ostium obliteration who underwent transcanalicular DCP and bicanalicular intubation']",[],"[{'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0332465', 'cui_str': 'Obliteration'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0332465', 'cui_str': 'Obliteration'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1531513', 'cui_str': 'Balloon dacryoplasty'}, {'cui': 'C3160746', 'cui_str': 'Dacryoplasty'}]",[],121.0,0.0123305,All stenoses and obliterations were recurrent and developed 6 months to 5 years after primary endonasal endoscopic DCR.,"[{'ForeName': 'E L', 'Initials': 'EL', 'LastName': ""At'kova"", 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'N N', 'Initials': 'NN', 'LastName': 'Krakhovetskiy', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Zhukov', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}]",Vestnik oftalmologii,['10.17116/oftalma2020136052163']
2736,33064065,A Pilot Study on In-Task Affect Predicting Free-Living Adherence to HIIT and MICT.,"Purpose : To report pilot test findings on whether in-task affect during a supervised exercise program, where participants were randomized to either moderate-intensity continuous training (MICT) or high-intensity interval training (HIIT), predicts changes in moderate-to-vigorous physical activity (MVPA-Total and MVPA10+ in bouts of ≥ 10 min) at 1- and 6-month post-intervention.  Method : This experimental study design randomized 32 inactive adults with prediabetes to complete a 2-week supervised MICT or HIIT plus behavioral counseling exercise intervention and objectively assessed free-living physical activity post-intervention. The Feeling Scale (FS) was used to assess the in-task effect. FS was measured in the middle of four, 1-min intervals in the HIIT condition, corresponding to ~20%, ~50%, ~75%, and ~85% of work out time. For the MICT condition, FS was assessed at similar exercise duration percentage times as HIIT. Accelerometer data evaluated MVPA at 1- and 6-month post-intervention.  Results : 32 adults were included in the analyses. Pilot findings indicated in-task affect between the conditions did not predict changes in MVPA-Total from baseline to 1 and 6 months. For MVPA10+, in-task affect negatively predicted MVPA10+ over time in the MICT condition only.  Conclusion : This study provides preliminary evidence that affect during MICT negatively predicts MVPA10+ over time, and that there is no difference of in-task affect's utility in predicting MVPA-Total between HIIT and MICT. Larger studies are required to confirm these findings.",2020,"For MVPA10+, in-task affect negatively predicted MVPA10+ over time in the MICT condition only.  ","['Results : 32 adults were included in the analyses', '32 inactive adults with prediabetes to complete a 2-week']","['moderate-intensity continuous training (MICT) or high-intensity interval training (HIIT), predicts changes in moderate-to-vigorous physical activity (MVPA-Total and MVPA10+ in bouts of ≥ 10\xa0min) at 1- and 6-month post-intervention', 'supervised exercise program', 'supervised MICT or HIIT plus behavioral counseling exercise intervention']","['Feeling Scale (FS', 'FS']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",32.0,0.0339123,"For MVPA10+, in-task affect negatively predicted MVPA10+ over time in the MICT condition only.  ","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Ivanova', 'Affiliation': 'University of British Columbia.'}, {'ForeName': 'Gentiana', 'Initials': 'G', 'LastName': 'Sadikaj', 'Affiliation': 'McGill University.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Bourne', 'Affiliation': 'University of Bristol.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Beauchamp', 'Affiliation': 'University of British Columbia.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'University of British Columbia.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Jung', 'Affiliation': 'University of British Columbia.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1828562']
2737,33064100,Effect of a Mobile App for the Pharmacotherapeutic Follow-Up of Patients With Cancer on Their Health Outcomes: Quasi-Experimental Study.,"BACKGROUND


Oral antineoplastic agents (OAAs) have revolutionized cancer management. However, they have been reported with adverse side effects and drug-drug interactions. Moreover, patient adherence to OAA treatment is critical. Mobile apps can enable remote and real-time pharmacotherapeutic monitoring of patients, while also promoting patient autonomy in their health care.
OBJECTIVE


The primary objective was to analyze the effect of using a mobile app for the follow-up of patients with oncohematological malignancies undergoing treatment with OAAs on their health outcomes. The secondary objectives were to analyze the role of the app in communication with health care professionals and patient satisfaction with the app.
METHODS


We performed a comparative, quasi-experimental study based on a prepost intervention with 101 patients (control group, n=51, traditional pharmacotherapeutic follow-up vs intervention group, n=50, follow-up through e-OncoSalud, a custom-designed app that promotes follow-up at home and the safety of patients receiving OAAs). The effect of this app on drug safety, adherence to treatment, and quality of life was evaluated.
RESULTS


With regard to drug safety, 73% (37/51) of the patients in the control group and 70% (35/50) of the patients in the intervention group (P=.01) presented with drug-related problems. The probability of detecting an insufficiently treated health problem in the intervention group was significantly higher than that in the control group (P=.04). The proportion of patients who presented with side effects in the intervention group was significantly lower than that in the control group (P>.99). In the control group, 49% (25/51) of the patients consumed some health resources during the first 6 months of treatment compared with 36% (18/50) of the patients in the intervention group (P=.76). Adherence to treatment was 97.6% (SD 7.9) in the intervention group, which was significantly higher than that in the control group (92.9% [SD 10.0]; P=.02). The EuroQol-5D in the intervention group yielded a mean (SD) index of 0.875 (0.156), which was significantly higher than that in the control group (0.741 [0.177]; P<.001). Approximately 60% (29/50) of the patients used the messaging module to communicate with pharmacists. The most frequent types of messages were acknowledgments (77/283, 27.2%), doubts about contraindications and interactions with OAAs (70/283, 24.7%), and consultations for adverse reactions to treatment (39/283, 13.8%). The satisfaction with the app survey conducted in the intervention group yielded an overall mean (SD) score of 9.1 (0.4) out of 10.
CONCLUSIONS


Use of e-OncoSalud for the real-time follow-up of patients receiving OAAs facilitated the optimization of some health outcomes. The intervention group had significantly higher health-related quality of life and adherence to treatment than the control group. Further, the probability of the intervention group presenting with side effects was significantly lower than that of the control group.",2020,The probability of detecting an insufficiently treated health problem in the intervention group was significantly higher than that in the control group (P=.04).,"['101 patients (control group, n=51', 'Patients With Cancer on Their Health Outcomes', 'patients with oncohematological malignancies undergoing treatment with OAAs on their health outcomes']","['Mobile App', 'traditional pharmacotherapeutic follow-up vs intervention group, n=50, follow-up through e-OncoSalud, a custom-designed app that promotes follow-up at home and the safety of patients receiving OAAs']","['overall mean (SD) score', 'drug safety, adherence to treatment, and quality of life', 'mean (SD) index', 'side effects', 'health resources', 'higher health-related quality of life and adherence', 'probability of detecting an insufficiently treated health problem']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",,0.0447273,The probability of detecting an insufficiently treated health problem in the intervention group was significantly higher than that in the control group (P=.04).,"[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Collado-Borrell', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Escudero-Vilaplana', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'Almudena', 'Initials': 'A', 'LastName': 'Ribed', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gonzalez-Anleo', 'Affiliation': 'Hospital Clinic Barcelona, Barcelona, Spain.'}, {'ForeName': 'Maite', 'Initials': 'M', 'LastName': 'Martin-Conde', 'Affiliation': 'Hospital Clinic Barcelona, Barcelona, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Romero-Jimenez', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Iglesias-Peinado', 'Affiliation': 'Faculty of Pharmacy, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Herranz-Alonso', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sanjurjo-Saez', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}]",JMIR mHealth and uHealth,['10.2196/20480']
2738,33064101,High-Intensity Interval Aerobic Resistance Training to Counteract Low Relative Appendicular Lean Soft Tissue Mass in Middle Age: Study Protocol for a Randomized Controlled Trial.,"BACKGROUND


Sarcopenia is the age-related loss of skeletal muscle mass and function and may exist in early middle age. Previous research in this area has focused on resistance training in older individuals; however, there is a lack of intervention trials in middle-aged adults with low relative appendicular lean soft tissue mass who may be at risk for sarcopenia in older age.
OBJECTIVE


This randomized controlled trial aims to determine the effects of a high-intensity interval aerobic resistance training intervention on appendicular lean soft tissue mass in middle-aged adults with low relative appendicular lean soft tissue mass.
METHODS


We will conduct a 40-week, single-blinded randomized controlled trial in 84 middle-aged adults with low appendicular lean soft tissue mass in the wider Dunedin area, New Zealand. We will randomly allocate participants to receive either a group-based, 20-week high-intensity interval aerobic resistance training intervention program or a single, 60-minute education session on current exercise recommendations. After the first 20 weeks, both groups will be given a 20-week home program. The study will assess primary and secondary outcome measures, including body composition (regional and whole-body lean soft tissue mass, fat mass, percentage body fat, measured by dual x-ray absorptiometry), blood biomarkers (cortisol, creatinine, C-reactive protein, lipid profile, hemoglobin), physical fitness (maximum oxygen consumption, blood pressure), physical activity (accelerometry), physical function (handgrip strength, sit-to-stand, gait speed, quadriceps strength), and self-reported questionnaires (health outcomes, self-efficacy, perceived enjoyment of physical activity, and multifactorial lifestyle), at baseline, 20 weeks, and 40 weeks. Physical function and self-reported questionnaires will also be measured at 10 weeks. We will assess the primary outcome measure, total body lean soft tissue mass, at baseline, 20 weeks, and 40 weeks. Analyses will be performed using intention-to-treat principles, comparing the outcomes resulting from the intervention, using linear mixed models.
RESULTS


We obtained ethical approval for this study from The University of Otago Human Ethics Committee on December 10, 2018. Participant recruitment started on February 11, 2019 and was completed on May 14, 2019. Data collection started on February 25, 2019 and was completed on February 28, 2020. We expect to publish the results in January 2021.
CONCLUSIONS


High-intensity interval aerobic resistance training is a time-efficient form of exercise, enabling busy middle-aged adults to meet physical activity recommendations while maximizing training results. The findings can inform the development of future prevention-focused interventions aimed at counteracting the high prevalence of sarcopenia in the aging population.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ACTRN12618001778279); https://tinyurl.com/y555z6fz.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/22989.",2020,"We will assess the primary outcome measure, total body lean soft tissue mass, at baseline, 20 weeks, and 40 weeks.","['middle-aged adults with low relative appendicular lean soft tissue mass', 'older individuals', 'Middle Age', '84 middle-aged adults with low appendicular lean soft tissue mass in the wider Dunedin area, New Zealand', 'middle-aged adults with low relative appendicular lean soft tissue mass who may be at risk for sarcopenia in older age', 'busy middle-aged adults']","['high-intensity interval aerobic resistance training intervention', 'High-Intensity Interval Aerobic Resistance Training', '20-week high-intensity interval aerobic resistance training intervention program or a single, 60-minute education session on current exercise recommendations', 'https://tinyurl.com/y555z6fz', 'High-intensity interval aerobic resistance training']","['total body lean soft tissue mass', 'body composition (regional and whole-body lean soft tissue mass, fat mass, percentage body fat, measured by dual x-ray absorptiometry), blood biomarkers (cortisol, creatinine, C-reactive protein, lipid profile, hemoglobin), physical fitness (maximum oxygen consumption, blood pressure), physical activity (accelerometry), physical function (handgrip strength, sit-to-stand, gait speed, quadriceps strength), and self-reported questionnaires (health outcomes, self-efficacy, perceived enjoyment of physical activity, and multifactorial lifestyle', 'appendicular lean soft tissue mass']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0457193', 'cui_str': 'Soft tissue mass'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0231337', 'cui_str': 'Senility'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0457193', 'cui_str': 'Soft tissue mass'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]",84.0,0.169898,"We will assess the primary outcome measure, total body lean soft tissue mass, at baseline, 20 weeks, and 40 weeks.","[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Vlietstra', 'Affiliation': 'Department of Medicine, Otago Medical School, Dunedin Campus, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Waters', 'Affiliation': 'Department of Medicine, Otago Medical School, Dunedin Campus, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Lynnette M', 'Initials': 'LM', 'LastName': 'Jones', 'Affiliation': 'School of Physical Education, Sport & Exercise Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Meredith-Jones', 'Affiliation': 'Department of Medicine, Otago Medical School, Dunedin Campus, University of Otago, Dunedin, New Zealand.'}]",JMIR research protocols,['10.2196/22989']
2739,33064182,"The effects of dapagliflozin, metformin or exercise on glycaemic variability in overweight or obese individuals with prediabetes (the PRE-D Trial): a multi-arm, randomised, controlled trial.","AIMS/HYPOTHESIS


We aimed to investigate the short-term efficacy and safety of three glucose-lowering interventions in overweight or obese individuals with prediabetes defined by HbA 1c .
METHODS


The PRE-D Trial was a randomised, controlled, parallel, multi-arm, open-label, non-blinded trial performed at Steno Diabetes Center Copenhagen, Gentofte, Denmark. One hundred and twenty participants with BMI ≥25 kg/m 2 , 30-70 years of age, and prediabetes (HbA 1c  39-47 mmol/mol [5.7-6.4%]) were randomised 1:1:1:1 to dapagliflozin (10 mg once daily), metformin (1700 mg daily), interval-based exercise (5 days/week, 30 min/session) or control (habitual lifestyle). Participants were examined at baseline and at 6, 13 and 26 weeks after randomisation. The primary outcome was the 13 week change in glycaemic variability (calculated as mean amplitude of glycaemic excursions [MAGE]) determined using a continuous glucose monitoring system (pre-specified minimal clinically important difference in MAGE ∼30%).
RESULTS


One hundred and twelve participants attended the examination at 13 weeks and 111 attended the follow-up visit at 26 weeks. Compared with the control group, there was a small decrease in MAGE in the dapagliflozin group (17.1% [95% CI 0.7, 30.8], p = 0.042) and a small, non-significant, reduction in the exercise group (15.3% [95% CI -1.2, 29.1], p = 0.067), whereas MAGE was unchanged in the metformin group (0.1% [95% CI -16.1, 19.4], p = 0.991)). Compared with the metformin group, MAGE was 17.2% (95% CI 0.8, 30.9; p = 0.041) lower in the dapagliflozin group and 15.4% (95% CI -1.1, 29.1; p = 0.065) lower in the exercise group after 13 weeks, with no difference between exercise and dapagliflozin (2.2% [95% CI -14.8, 22.5], p = 0.815). One serious adverse event occurred in the control group (lung cancer).
CONCLUSIONS/INTERPRETATION


Treatment with dapagliflozin and interval-based exercise lead to similar but small improvements in glycaemic variability compared with control and metformin therapy. The clinical importance of these findings in prediabetes is uncertain.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02695810 FUNDING: The study was funded by the Novo Nordisk Foundation, AstraZeneca AB, the Danish Innovation Foundation, the University of Copenhagen and Ascensia Diabetes Care Denmark ApS Graphical abstract.",2020,"Compared with the control group, there was a small decrease in MAGE in the dapagliflozin group (17.1% [95% CI 0.7, 30.8], p = 0.042) and a small, non-significant, reduction in the exercise group (15.3% [95% CI -1.2, 29.1], p = 0.067), whereas MAGE was unchanged in the metformin group (0.1% [95% CI -16.1, 19.4], p = 0.991)).","['kg/m 2 , 30-70\xa0years of age, and prediabetes (HbA 1c  39-47\xa0mmol/mol [5.7-6.4', 'overweight or obese individuals with prediabetes defined by HbA 1c ', 'overweight or obese individuals with prediabetes (the PRE-D Trial', 'One hundred and twenty participants with BMI ≥25', 'One hundred and twelve participants attended the examination at 13\xa0weeks and 111 attended the follow-up visit at 26\xa0weeks']","['dapagliflozin, metformin or exercise', 'glucose-lowering interventions', 'metformin', 'dapagliflozin']","['continuous glucose monitoring system', 'MAGE', 'glycaemic variability', '13\xa0week change in glycaemic variability (calculated as mean amplitude of glycaemic excursions [MAGE']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",120.0,0.157051,"Compared with the control group, there was a small decrease in MAGE in the dapagliflozin group (17.1% [95% CI 0.7, 30.8], p = 0.042) and a small, non-significant, reduction in the exercise group (15.3% [95% CI -1.2, 29.1], p = 0.067), whereas MAGE was unchanged in the metformin group (0.1% [95% CI -16.1, 19.4], p = 0.991)).","[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Færch', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark. kristine.faerch@regionh.dk.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Blond', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Bruhn', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Amadid', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Vistisen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Kim K B', 'Initials': 'KKB', 'LastName': 'Clemmensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Camilla T R', 'Initials': 'CTR', 'LastName': 'Vainø', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Pedersen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tvermosegaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Dejgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Karstoft', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Ried-Larsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Persson', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Marit E', 'Initials': 'ME', 'LastName': 'Jørgensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}]",Diabetologia,['10.1007/s00125-020-05306-1']
2740,33064204,Correction to: Pre-post analysis of a social capital-based exercise adherence intervention for breast cancer survivors with moderate fatigue: a randomized controlled trial.,"Tables 1, 2, and 3 are incorrect.",2020,"Tables 1, 2, and 3 are incorrect.",['breast cancer survivors with moderate fatigue'],['social capital-based exercise adherence intervention'],[],"[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]","[{'cui': 'C1510639', 'cui_str': 'Social Capital'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.126927,"Tables 1, 2, and 3 are incorrect.","[{'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Mo-Im Kim Nursing Research Institute, College of Nursing, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, South Korea.'}, {'ForeName': 'Yun Hee', 'Initials': 'YH', 'LastName': 'Ko', 'Affiliation': 'Mo-Im Kim Nursing Research Institute, College of Nursing, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, South Korea.'}, {'ForeName': 'Yoonkyung', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Sports Industry Studies, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, South Korea.'}, {'ForeName': 'Min Jae', 'Initials': 'MJ', 'LastName': 'Kang', 'Affiliation': 'Department of Sports Industry Studies, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, South Korea.'}, {'ForeName': 'Hyojin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Mo-Im Kim Nursing Research Institute, College of Nursing, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, South Korea.'}, {'ForeName': 'Sung Hae', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, College of Health. Welfare and Education, Tongmyong University, Busan, South Korea.'}, {'ForeName': 'Justin Y', 'Initials': 'JY', 'LastName': 'Jeon', 'Affiliation': 'Department of Sports Industry Studies, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, South Korea.'}, {'ForeName': 'Young Up', 'Initials': 'YU', 'LastName': 'Cho', 'Affiliation': 'Formerly affiliated with Yonsei University Health System, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, South Korea.'}, {'ForeName': 'Gihong', 'Initials': 'G', 'LastName': 'Yi', 'Affiliation': 'Department of Sociology, Hallym University, 1,Hallymdaehak-gil, Chuncheon-si, Gangwon-do, 24252, South Korea.'}, {'ForeName': 'Jeehee', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Mo-Im Kim Nursing Research Institute, College of Nursing, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, South Korea. hjihee1225@hanmail.net.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05823-0']
2741,33064404,Effects of Cognitive Training and Exergaming in Pediatric Cancer Survivors-A Randomized Clinical Trial.,"PURPOSE


Although most pediatric cancer patients survive, those who undergo anticancer treatments like chemotherapy and/or radiotherapy are at a high risk for late effects, such as cognitive deficits. To counteract these deficits, feasible and effective interventions are needed. The aim of this study was to compare the effects of working memory training, exergaming, and a wait-list control condition on cognitive functions in pediatric cancer survivors.
METHODS


In a parallel-group randomized trial, 69 pediatric cancer survivors aged 7-16 yr (mean = 11.35, SD = 3.53) were randomly assigned to 8-wk working memory training, exergaming, or a wait-list control group. Each training course consisted of three 45-min training sessions per week. The primary outcome comprised the core executive functions (visual working memory, inhibition, switching), and the secondary outcomes included other cognitive domains (intelligence, planning, memory, attention, processing speed), motor abilities, and parent rating on their children's executive functions. Assessments were conducted both before and immediately after the interventions, and at 3-month follow-up.
RESULTS


Linear mixed models revealed that participants in the working memory training group showed a linear improvement in visual working memory after training and at follow-up compared with the control group. No other intervention effects of either type of training could be detected.
CONCLUSION


This study presents evidence that working memory training improves visual working memory in pediatric cancer survivors. Results show that near-transfer, but no far-transfer effects can be expected from working memory training. Multiple-component interventions tailored to fit the individual's cognitive profile are needed to best support cognitive development after cancer and its treatment.",2020,"RESULTS


Linear mixed models revealed that participants in the working memory training group showed a linear improvement in visual working memory after training and at follow-up compared with the control group.","['Pediatric Cancer Survivors', 'pediatric cancer survivors', 'pediatric cancer patients survive, those who undergo anticancer treatments like', '69 pediatric cancer survivors aged 7-16 yr (mean = 11.35, SD = 3.53']","['Cognitive Training and Exergaming', '8-wk working memory training, exergaming, or a wait-list control group', 'working memory training, exergaming, and a wait-list control condition', 'working memory training', 'chemotherapy and/or radiotherapy']","['visual working memory', ""core executive functions (visual working memory, inhibition, switching), and the secondary outcomes included other cognitive domains (intelligence, planning, memory, attention, processing speed), motor abilities, and parent rating on their children's executive functions""]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",69.0,0.0718329,"RESULTS


Linear mixed models revealed that participants in the working memory training group showed a linear improvement in visual working memory after training and at follow-up compared with the control group.","[{'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Benzing', 'Affiliation': ""1Institute of Sport Science, University of Bern, Bern, SWITZERLAND 2Division of Pediatric Hematology and Oncology, University Children's Hospital Bern, Inselspital, Bern University Hospital, University of Bern, Bern, SWITZERLAND 3Division of Neuropaediatrics, Development and Rehabilitation, University Children's Hospital Bern, Inselspital, Bern University Hospital, University of Bern, Bern, SWITZERLAND 4Institute of Psychology, University of Bern, Bern, SWITZERLAND 5Division of Pediatric Oncology, University Children's Hospital Zurich, Zurich, SWITZERLAND.""}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'SpitzhÜttl', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Siegwart', 'Affiliation': ''}, {'ForeName': 'JÜrg', 'Initials': 'J', 'LastName': 'Schmid', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grotzer', 'Affiliation': ''}, {'ForeName': 'Theda', 'Initials': 'T', 'LastName': 'Heinks', 'Affiliation': ''}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Roebers', 'Affiliation': ''}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Steinlin', 'Affiliation': ''}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Leibundgut', 'Affiliation': ''}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'Regula', 'Initials': 'R', 'LastName': 'Everts', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002386']
2742,33064410,"Is There a Link between Stress and Cognition, and Capacity to Execute Motor Skill?","PURPOSE


This study aimed to examine the link between stress (measured via salivary cortisol and testosterone), cognition (measured via pupillometry, with greater pupil constriction and reduced pupil constriction latency associated with increased attention and improved information processing), and motor skill capacity (measured via somatosensory processing).
METHODS


Twenty-five professional rugby players participated in this study. Saliva samples were collected upon waking, before pupillometry and somatosensory processing testing, and after testing. Testing times varied for participants; however, it was always in the morning, and the order of testing was randomized.
RESULTS


Very small differences in hormone concentrations were seen across the morning (effect size = 0.01). Moderate to large differences in left eye pupil constriction for direct (left eye) versus consensual (right eye) stimulus were also seen (P < 0.01; effect size = 0.51 to 1.04). No differences for pupil constriction latency were seen for direct versus consensual stimulus. Some positive weak to moderate relationships were seen for testosterone and pupil constriction latency (r = 0.37 to 0.39, P < 0.05). Moderate to strong inverse relationships were seen for hormones with left eye pupil constriction difference between direct and consensual stimulus, and for pre- to posttest testosterone-to-cortisol ratio decline with left eye pupil constriction for direct and consensual stimulus (r = 0.41 to 0.52, P < 0.05). Weak to moderate inverse relationships for testosterone-to-cortisol ratio decline and somatosensory processing were seen (r = 0.36 to 0.47, P < 0.05).
CONCLUSION


Stress may affect ability to receive information and ability to execute motor tasks. Thus, stress may compromise ability to make appropriate objective decisions and consequently execute skill/task behavior. Strategies to help mitigate negative stress responses are noted.",2020,"Moderate to strong inverse relationships were seen for hormones with left eye pupil constriction difference between direct and consensual stimulus, and for pre- to posttest testosterone-to-cortisol ratio decline with left eye pupil constriction for direct and consensual stimulus (r = 0.41 to 0.52, P < 0.05).",['Twenty-five professional rugby players participated in this study'],[],"['pupil constriction latency', 'hormone concentrations', 'testosterone-to-cortisol ratio decline and somatosensory processing', 'stress (measured via salivary cortisol and testosterone), cognition (measured via pupillometry, with greater pupil constriction and reduced pupil constriction latency associated with increased attention and improved information processing), and motor skill capacity (measured via somatosensory processing', 'testosterone and pupil constriction latency']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0026205', 'cui_str': 'Persistent miosis'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}]",25.0,0.0355224,"Moderate to strong inverse relationships were seen for hormones with left eye pupil constriction difference between direct and consensual stimulus, and for pre- to posttest testosterone-to-cortisol ratio decline with left eye pupil constriction for direct and consensual stimulus (r = 0.41 to 0.52, P < 0.05).","[{'ForeName': 'Benjamin G', 'Initials': 'BG', 'LastName': 'Serpell', 'Affiliation': '1University of Canberra Research Institute for Sport and Exercise (UCRISE), University of Canberra, Bruce, AUSTRALIA 2Brumbies Rugby, Bruce, AUSTRALIA 3Performance People and Teams, Australian Institute of Sport, Bruce, AUSTRALIA 4Sports Medicine, Australian Institute of Sport, Bruce, AUSTRALIA 5Human Factors and Behavioral Neurobiology Department, Embry-Riddle Aeronautical University, Daytona Beach, FL 6Human Performance, Sport and Physiology Group, Brain-Behaviour Research Group, Biomedical Discipline School of Science and Technology, University of New England, Armidale, AUSTRALIA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Waddington', 'Affiliation': ''}, {'ForeName': 'Braden', 'Initials': 'B', 'LastName': 'McGrath', 'Affiliation': ''}, {'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Cook', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002397']
2743,33064412,Exercise Training Improves Microvascular Function in Burn Injury Survivors.,"INTRODUCTION


Vasodilator function is impaired in individuals with well-healed burn injuries; however, therapeutic interventions that lessen or reverse this maladaptation are lacking. The purpose of this study was to test the hypothesis that a 6-month community-based exercise training program would increase microvascular dilator function in individuals with well-healed burn injuries, irrespective of the magnitude of the injured body surface area. Further, we hypothesize that macrovascular dilator function would remain unchanged posttraining.
METHODS


Microvascular function (forearm reactive hyperemia), macrovascular function (brachial artery flow-mediated dilation), and the maximal vasodilatory response after ischemic handgrip exercise (an estimate of microvascular remodeling) were assessed before and after exercise training in nonburned control subjects (n = 11) and individuals with burn injuries covering a moderate body surface area (26% ± 7%; n = 13) and a high body surface area (59% ± 15%; n = 19).
RESULTS


Peak vascular conductance and area under the curve during postocclusive reactive hyperemia increased from pretraining to posttraining in control and burn injury groups (both P < 0.05), the magnitude of which did not differ between groups (both P = 0.6). Likewise, the maximal vasodilatory response after ischemic handgrip exercise increased in all groups after exercise training (P < 0.05). Macrovascular dilator function did not differ across time or between groups (P = 0.8).
CONCLUSIONS


These data suggest that a community-based exercise training program improves microvascular function in individuals with well-healed burn injuries, which may be due in part to vascular remodeling.",2020,"Macrovascular dilator function did not differ across time or between groups (P = 0.8).
","['individuals with well-healed burn injuries', 'Burn Injury Survivors', 'nonburned control subjects (n = 11) and individuals with burn injuries covering a moderate body surface area (26% ± 7%; n = 13) and a high body surface area (59% ± 15%; n = 19']","['ischemic handgrip exercise', 'community-based exercise training program', 'exercise training', 'Exercise Training']","['macrovascular dilator function', 'Microvascular Function', 'maximal vasodilatory response after ischemic handgrip exercise', 'microvascular dilator function', 'Macrovascular dilator function', 'Peak vascular conductance and area under the curve during postocclusive reactive hyperemia', 'Microvascular function (forearm reactive hyperemia), macrovascular function (brachial artery flow-mediated dilation', 'microvascular function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0180431', 'cui_str': 'Dilator'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}]",,0.019027,"Macrovascular dilator function did not differ across time or between groups (P = 0.8).
","[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Romero', 'Affiliation': '1University of Texas Southwestern Medical Center and Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX 2University of North Texas Health Science Center, Ft. Worth, TX.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Moralez', 'Affiliation': ''}, {'ForeName': 'Manall F', 'Initials': 'MF', 'LastName': 'Jaffery', 'Affiliation': ''}, {'ForeName': 'M U', 'Initials': 'MU', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Engelland', 'Affiliation': ''}, {'ForeName': 'Matthew N', 'Initials': 'MN', 'LastName': 'Cramer', 'Affiliation': ''}, {'ForeName': 'Craig G', 'Initials': 'CG', 'LastName': 'Crandall', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002379']
2744,33064413,Synergetic Effect of NO Precursor Supplementation and Exercise Training.,"INTRODUCTION


Nitric oxide (NO) precursor supplementation has been shown to increase NO bioavailability and can potentially improve vascular function and exercise performance. It remains unclear whether the combination of NO precursor supplementation and exercise training has synergic effects on exercise performance. This study aims to assess the effect of chronic nitrate and citrulline intake on exercise training adaptations in healthy young individuals.
METHODS


In this randomized, double-bind trial, 24 healthy young (12 females) subjects performed vascular function assessment (blood pressure, pulse wave velocity, postischemia vasodilation, and cerebrovascular reactivity) and both local (submaximal isometric unilateral knee extension) and whole-body (incremental cycling) exercise tests to exhaustion before and after a 2-month exercise training program and daily intake of a placebo or a nitrate-rich salad and citrulline (N + C, 520 mg nitrate and 6 g citrulline) drink. Prefrontal cortex and quadriceps oxygenation was monitored continuously during exercise by near-infrared spectroscopy.
RESULTS


N + C supplementation had no effect on vascular function and muscle and cerebral oxygenation during both local and whole-body exercise. N + C supplementation induced a significantly larger increase in maximal knee extensor strength (+5.1 ± 3.5 vs +0.2 ± 5.5 kg, P = 0.008) as well as a trend toward a larger increase in knee extensor endurance (+35.2 ± 26.1 vs +24.0 ± 10.4 contractions, P = 0.092) than placebo, but no effect on exercise training-induced maximal aerobic performance improvement.
CONCLUSION


These results suggest that chronic nitrate and citrulline supplementation enhances the effect of exercise training on quadriceps muscle function in healthy active young individuals, but this does not translate into improved maximal aerobic performances.",2020,"N + C supplementation induced a significantly larger increase in maximal knee extensor strength (+5.1 ± 3.5 vs +0.2 ± 5.5 kg, P = 0.008) as well as a trend toward a larger increase in knee extensor endurance (+35.2 ± 26.1 vs +24.0 ± 10.4 contractions, P = 0.092) than placebo, but no effect on exercise training-induced maximal aerobic performance improvement.
","['healthy young individuals', '24 healthy young (12 females) subjects performed', 'healthy active young individuals']","['N + C supplementation', 'exercise training', 'placebo', 'Nitric oxide ', 'chronic nitrate and citrulline intake', 'NO Precursor Supplementation and Exercise Training', 'local (submaximal isometric unilateral knee extension) and whole-body (incremental cycling) exercise tests to exhaustion before and after a 2-month exercise training program and daily intake of a placebo or a nitrate-rich salad and citrulline (N + C, 520 mg nitrate and 6 g citrulline) drink']","['Prefrontal cortex and quadriceps oxygenation', 'vascular function assessment (blood pressure, pulse wave velocity, postischemia vasodilation, and cerebrovascular reactivity', 'vascular function and muscle and cerebral oxygenation', 'maximal aerobic performances', 'maximal aerobic performance improvement', 'vascular function and exercise performance', 'knee extensor endurance', 'maximal knee extensor strength', 'quadriceps muscle function']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0453740', 'cui_str': 'Salad'}, {'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}]",24.0,0.0624846,"N + C supplementation induced a significantly larger increase in maximal knee extensor strength (+5.1 ± 3.5 vs +0.2 ± 5.5 kg, P = 0.008) as well as a trend toward a larger increase in knee extensor endurance (+35.2 ± 26.1 vs +24.0 ± 10.4 contractions, P = 0.092) than placebo, but no effect on exercise training-induced maximal aerobic performance improvement.
","[{'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'LE Roux-Mallouf', 'Affiliation': '1HP2 Laboratory INSERM U1042, Faculty of Medicine, Université Grenoble Alpes, Grenoble, FRANCE 2Sport and Pathologies Unit, Grenoble Alpes University Hospital, Hôpital Michallon, Grenoble, FRANCE.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Vallejo', 'Affiliation': ''}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Pelen', 'Affiliation': ''}, {'ForeName': 'Idir', 'Initials': 'I', 'LastName': 'Halimaoui', 'Affiliation': ''}, {'ForeName': 'StÉphane', 'Initials': 'S', 'LastName': 'Doutreleau', 'Affiliation': ''}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Verges', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002387']
2745,33060415,Alternate Light Source Findings of Common Topical Cosmetics and Three Removal Methods.,"INTRODUCTION


Alternate light sources (ALSs) are a tool used by forensic nurses to aid in the physical examination of patients. Prior research has shown some topical makeup products absorb alternate light similar to the absorption noted in bruises. Therefore, the purposes of this study were (a) to further examine the ALS findings of multiple brands and types of makeup products and (b) to compare the efficacy of three methods of makeup removal.
METHODS


Fourteen makeup products were applied to the forearms of 100 healthy adult volunteers with varying skin tones and then assessed under white light, six alternate light wavelengths, and three color filters, producing 19 total wavelength-and-filter combinations. The results were recorded before and after removal procedures by forensic nurse examiners who were blinded to the removal method. A three-arm randomized controlled trial of makeup removal methods (soap and water, isopropyl alcohol swab, makeup removal wipe) was conducted with the participants.
RESULTS


All 14 makeup products produced absorption in at least 10% of the observations. Fluorescence was observed in more than 10% of the observations for only two products. After product removal, four products continued to produce statistically significant absorption findings when viewed under an ALS. One product produced significant fluorescence after removal procedures. There were no statistically significant differences between the removal methods noted in any of these analyses.
CONCLUSION


Our findings support the importance of using alternate light as one component of a comprehensive forensic examination, including history taking and physical examination.",2020,"There were no statistically significant differences between the removal methods noted in any of these analyses.
","['Fourteen makeup products were applied to the forearms of 100 healthy adult volunteers with varying skin tones and then assessed under white light, six alternate light wavelengths, and three color filters, producing 19 total wavelength-and-filter combinations']","['makeup removal methods (soap and water, isopropyl alcohol swab, makeup removal wipe']",['Fluorescence'],"[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0037290', 'cui_str': 'Skin pigmentation'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0022237', 'cui_str': 'Isopropyl Alcohol'}, {'cui': 'C0183753', 'cui_str': 'Swab'}]","[{'cui': 'C0016315', 'cui_str': 'Fluorescence'}]",100.0,0.0712119,"There were no statistically significant differences between the removal methods noted in any of these analyses.
","[{'ForeName': 'Jocelyn C', 'Initials': 'JC', 'LastName': 'Anderson', 'Affiliation': 'Author Affiliations:Pennsylvania State University College of Nursing.'}, {'ForeName': 'Erin N', 'Initials': 'EN', 'LastName': 'Pollitt', 'Affiliation': 'Mercy Medical Center.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Schildbach', 'Affiliation': 'Mercy Medical Center.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'MacDonald', 'Affiliation': 'Mercy Medical Center.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Rose', 'Affiliation': 'Author Affiliations:Pennsylvania State University College of Nursing.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Sheridan', 'Affiliation': 'Johns Hopkins University School of Nursing.'}]",Journal of forensic nursing,['10.1097/JFN.0000000000000300']
2746,33060432,"Comparison of Rapid Antidepressant and Antisuicidal Effects of Intramuscular Ketamine, Oral Ketamine, and Electroconvulsive Therapy in Patients With Major Depressive Disorder: A Pilot Study.","PURPOSE/BACKGROUND


This study was devised to compare the antidepressant and antisuicidal effects of oral and intramuscular (IM) ketamine versus electroconvulsive therapy (ECT).
METHODS/PROCEDURES


In our pilot study, 45 patients with major depressive disorder (based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria) in the age range of 18 to 70 years who were determined suitable candidates for ECT got randomly divided into 3 equal groups. Each group received one of these treatment modalities: 0.5 mg/kg of IM ketamine; 1 mg/kg of oral ketamine; and ECT in 6 to 9 sessions during 3 weeks. Depression and suicidal ideation scores were recorded using the Hamilton Depression Rating Scale and the Beck Scale for Suicidal Ideation, respectively, at baseline, 24 hours, 1 week, 2 weeks, and 3 weeks within the intervention. The measurements were repeated 1 week and 1 month after the end of the intervention as well. Vital signs and adverse effects were noted. Finally, satisfaction levels of patients for each method were recorded and compared between groups.
FINDINGS/RESULTS


The Hamilton Depression Rating Scale and the Beck Scale for Suicidal Ideation scores significantly improved in all groups compared with baseline with no significant differences between the 3 groups. The adverse effects for ketamine-consuming groups such as dissociative symptoms were brief and transient, whereas memory loss for the ECT group remained up to 1 month in some patients. Ketamine-receiving groups preferred it more than ECT.
IMPLICATIONS/CONCLUSIONS


Oral and IM ketamine probably have equal antidepressant in addition to more antisuicidal effects compared with ECT but had less cognitive adverse effects and higher preference by patients. Thereby, ketamine can be an alternative method in the treatment of patients with severe and/or suicidal MDD.",2020,The Hamilton Depression Rating Scale and the Beck Scale for Suicidal Ideation scores significantly improved in all groups compared with baseline with no significant differences between the 3 groups.,"['45 patients with major depressive disorder (based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria) in the age range of 18 to 70 years who were determined suitable candidates for ECT got randomly divided into 3 equal groups', 'Patients With Major Depressive Disorder', 'patients with severe and/or suicidal MDD']","['ECT', 'Ketamine', 'IM ketamine; 1 mg/kg of oral ketamine; and ECT', 'Intramuscular Ketamine, Oral Ketamine, and Electroconvulsive Therapy', 'ketamine', 'Oral and IM ketamine', 'oral and intramuscular (IM) ketamine', 'electroconvulsive therapy (ECT']","['Depression and suicidal ideation scores', 'cognitive adverse effects', 'Vital signs and adverse effects', 'Hamilton Depression Rating Scale and the Beck Scale for Suicidal Ideation scores', 'satisfaction levels', 'adverse effects', 'Hamilton Depression Rating Scale and the Beck Scale for Suicidal Ideation', 'memory loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C1269683', 'cui_str': 'Major depressive disorder'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002622', 'cui_str': 'Amnesia'}]",45.0,0.0225525,The Hamilton Depression Rating Scale and the Beck Scale for Suicidal Ideation scores significantly improved in all groups compared with baseline with no significant differences between the 3 groups.,"[{'ForeName': 'Dorna', 'Initials': 'D', 'LastName': 'Kheirabadi', 'Affiliation': 'From the Department of Anesthesiology, School of Medicine, Behavioral Sciences Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Kheirabadi', 'Affiliation': 'Behavioral Sciences Research Center, Department of Psychiatry, School of Medicine.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mirlohi', 'Affiliation': 'Department of Psychiatry, School of Medicine.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Tarrahi', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, IsfahanUniversity of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Norbaksh', 'Affiliation': 'South Coast Specialty Surgery Center.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001289']
2747,33060436,Vitamin D in Children With Inflammatory Bowel Disease: A Randomized Controlled Clinical Trial.,"BACKGROUND


Vitamin D has anti-inflammatory and immune regulatory functions.
GOALS


The authors investigated the effect of vitamin D supplementation in children with inflammatory bowel disease (IBD) and hypovitaminosis D on disease activity, quality of life (QOL), inflammatory markers, and cytokines.
STUDY


This randomized double-blinded controlled clinical trial included 120 children with IBD and hypovitaminosis D; 22 of them were excluded later. Patients were randomized to receive either oral vitamin D3 in a dose of 2000 IU/day or placebo for 6 months. The primary outcome was to evaluate the effect of vitamin D supplementation on the IBD activity score. The secondary outcomes were to assess the QOL, inflammatory markers, cytokines, the safety of vitamin D, and to correlate serum vitamin D level with various clinical and laboratory variables.
RESULTS


Vitamin D supplementation significantly decreased the IBD activity score in the vitamin D group compared with the placebo group. Moreover, QOL significantly improved after vitamin D supplementation. Inflammatory markers, for example, erythrocyte sedimentation rate, C-reactive protein, and fecal calprotectin and interleukin-2 IL-12, IL-17, IL-23, and tumor necrosis factor-alpha significantly decreased in the vitamin D group. However, IL-10 significantly increased after vitamin D supplementation. Vitamin D was significantly inversely correlated with the activity score, QOL score, levels of all inflammatory markers, the frequency of hospitalization, and emergency department visits.
CONCLUSION


Vitamin D supplementation may have a beneficial effect in children with IBD.",2020,"Inflammatory markers, for example, erythrocyte sedimentation rate, C-reactive protein, and fecal calprotectin and interleukin-2 IL-12, IL-17, IL-23, and tumor necrosis factor-alpha significantly decreased in the vitamin D group.","['Children With Inflammatory Bowel Disease', 'children with IBD', '120 children with IBD and hypovitaminosis D; 22 of them were excluded later', 'children with inflammatory bowel disease (IBD']","['vitamin D supplementation', 'Vitamin D', 'placebo', 'oral vitamin D3', 'Vitamin D supplementation']","['erythrocyte sedimentation rate, C-reactive protein, and fecal calprotectin and interleukin-2 IL-12, IL-17, IL-23, and tumor necrosis factor-alpha', 'activity score, QOL score, levels of all inflammatory markers, the frequency of hospitalization, and emergency department visits', 'Vitamin D', 'disease activity, quality of life (QOL), inflammatory markers, and cytokines', 'QOL', 'QOL, inflammatory markers, cytokines, the safety of vitamin D, and to correlate serum vitamin D level with various clinical and laboratory variables', 'IL-10', 'IBD activity score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0035579', 'cui_str': 'Rickets'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}]",120.0,0.628802,"Inflammatory markers, for example, erythrocyte sedimentation rate, C-reactive protein, and fecal calprotectin and interleukin-2 IL-12, IL-17, IL-23, and tumor necrosis factor-alpha significantly decreased in the vitamin D group.","[{'ForeName': 'Doaa', 'Initials': 'D', 'LastName': 'El Amrousy', 'Affiliation': 'Pediatric Department.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'El Ashry', 'Affiliation': 'Tropical Medicine Department.'}, {'ForeName': 'Hossam', 'Initials': 'H', 'LastName': 'Hodeib', 'Affiliation': 'Clinical Pathology Department, Faculty of Medicine, Tanta University, Egypt.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Hassan', 'Affiliation': 'Pediatric Department.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001443']
2748,33060437,Combined PEG3350 Plus Lactulose Results in Early Resolution of Hepatic Encephalopathy and Improved 28-Day Survival in Acute-on-Chronic Liver Failure.,"BACKGROUND AND AIMS


Acute-on-chronic liver failure (ACLF) is associated with high short-term mortality in those with hepatic encephalopathy (HE). Polyethylene glycol (PEG) 3350 electrolyte solution can ensure rapid gut catharsis, which may resolve HE more effectively than lactulose. In this open-label-randomized trial, we compared PEG+lactulose versus lactulose alone in ACLF with HE grade ≥2 for efficacy and outcome.
PATIENTS AND METHODS


Patients were randomized to receive PEG (2 L q12 h) followed by lactulose (30 mL q8 h) or standard medical treatment [SMT, lactulose (titrated 30 mL q8 h)]. Endpoints were HE grade improvement at 24 hours, 48 hours, and 7 days using hepatic encephalopathy scoring algorithm (HESA), ammonia reduction, HE resolution, and survival benefit.
RESULTS


Of 60 patients, 29 were randomized to PEG+lactulose arm and 31 to SMT. In the PEG arm, early reduction in HESA score was noted in more persons [18 (62.1%) vs. 10 (32.2%); P=0.021] with a shorter median time to HE resolution [4.5 (3 to 9) d vs. 9 (8 to 11) d; P=0.023]. On multivariate analysis, age [hazard ratio (HR),1.06 (1.00 to 1.13); P=0.03], HESA score [HR, 6.01 (1.27 to 28.5); P=0.024], and model for end-stage liver disease [HR, 1.26 (1.01 to 1.53); P=0.022] were predictors of mortality at 28 days. Ammonia level or reduction did not correlate with HE grades. Adverse events included excessive diarrhea (20.6% vs. 9.6%) in the PEG and SMT arms, albeit without dyselectrolytemia or worsened renal function. In the PEG versus SMT arm, survival at 28 days were 93.1% versus 67.7% (P=0.010) and at 90 days was 68.9% versus 48.3% (P=0.940), respectively, with fewer persons relapsing with HE in the PEG arm.
CONCLUSIONS


PEG resulted in early and sustained HE resolution with improved short-term survival making, it a suitable and safe drug in patients with acute HE in ACLF.",2020,"Adverse events included excessive diarrhea (20.6% vs. 9.6%) in the PEG and SMT arms, albeit without dyselectrolytemia or worsened renal function.","['60 patients, 29 were randomized to PEG+lactulose arm and 31 to SMT', 'Patients', 'patients with acute HE in ACLF']","['PEG (2\u2009L q12\u2009h) followed by lactulose (30\u2009mL q8\u2009h) or standard medical treatment [SMT, lactulose', 'Combined PEG3350 Plus Lactulose', 'PEG+lactulose versus lactulose', 'Polyethylene glycol (PEG) 3350 electrolyte solution']","['Early Resolution of Hepatic Encephalopathy and Improved 28-Day Survival', 'dyselectrolytemia or worsened renal function', 'median time to HE resolution', 'Ammonia level or reduction', 'hepatic encephalopathy scoring algorithm (HESA), ammonia reduction, HE resolution, and survival benefit', 'HESA score', 'excessive diarrhea', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C3850141', 'cui_str': 'Acute on chronic liver failure'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0724672', 'cui_str': 'POLYETHYLENE GLYCOL 3350'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C3541941', 'cui_str': 'Electrolyte solutions'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0201879', 'cui_str': 'Ammonia measurement'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",3350.0,0.216378,"Adverse events included excessive diarrhea (20.6% vs. 9.6%) in the PEG and SMT arms, albeit without dyselectrolytemia or worsened renal function.","[{'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'Departments of Internal Medicine.'}, {'ForeName': 'Madhumita', 'Initials': 'M', 'LastName': 'Premkumar', 'Affiliation': 'Hepatology.'}, {'ForeName': 'Radha K', 'Initials': 'RK', 'LastName': 'Dhiman', 'Affiliation': 'Hepatology.'}, {'ForeName': 'Anand V', 'Initials': 'AV', 'LastName': 'Kulkarni', 'Affiliation': 'Department of Hepatology and Liver Transplantation, Asian Institute of Gastroenterology, Hyderabad, India.'}, {'ForeName': 'Rather', 'Initials': 'R', 'LastName': 'Imran', 'Affiliation': 'Pharmacology.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Duseja', 'Affiliation': 'Hepatology.'}, {'ForeName': 'Prabhdeep', 'Initials': 'P', 'LastName': 'Kaur', 'Affiliation': 'Biochemistry, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Taneja', 'Affiliation': 'Hepatology.'}, {'ForeName': 'Virendra', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'Hepatology.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Mishra', 'Affiliation': 'Hepatology.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Hepatology.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Mehtani', 'Affiliation': 'Hepatology.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001450']
2749,33060496,Effect of Guided Imagery Along With Breathing Relaxation on Sleep Quality of the Elderly Patients Under Abdominal Surgery: A Randomized Clinical Trial.,"Elderly patients undergoing surgery often suffer from sleep disorder. Holistic therapies might help them sleep better. The aim of this research was to determine the effect of guided imagery along with breathing relaxation on sleep quality in elderly patients undergoing abdominal surgery. A double-blind randomized clinical trial was conducted on 90 elderly patients undergoing abdominal surgery in 2 educational hospitals in 2018, Mashhad, Iran. The elderly patients with different abdominal surgical procedures were distributed to the wardrooms and then the rooms were randomly assigned into 2 groups. In the intervention group, the patients learned breathing relaxation the day before surgery and then an audiotape was provided to perform the guided imagery from the day before surgery for 5 days (twice) along with breathing relaxation. St Mary's Hospital Sleep Inventory was completed the night before, 48 hours and 96 hours after the surgery. Data analysis was done using SPSS 21 through analytical tests. Results of the test indicated that the score of sleep quality was significantly higher in the intervention group the night before surgery (P = .001). The total scores of sleep quality in the intervention group 48 and 96 hours after the surgery were significantly higher (P < .001). Based on results of generalized estimating equation model, the score of sleep quality for patients was 8.76 units higher in the intervention group than in the control group by controlling for the effects of time. Guided imagery along with breathing relaxation improved the sleep quality of the elderly patients undergoing abdominal surgery.Trial registration: IRCT20180731040652N1.",2020,The total scores of sleep quality in the intervention group 48 and 96 hours after the surgery were significantly higher (P < .001).,"['90 elderly patients undergoing abdominal surgery in 2 educational hospitals in 2018, Mashhad, Iran', 'Elderly patients undergoing surgery often suffer from sleep disorder', 'elderly patients undergoing abdominal surgery', 'Elderly Patients Under Abdominal Surgery', 'elderly patients with different abdominal surgical procedures']","['Guided imagery along with breathing relaxation', 'Breathing Relaxation', 'Guided Imagery', 'guided imagery along with breathing relaxation']","['score of sleep quality', 'sleep quality', 'total scores of sleep quality', 'Sleep Quality', ""St Mary's Hospital Sleep Inventory""]","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",90.0,0.0821108,The total scores of sleep quality in the intervention group 48 and 96 hours after the surgery were significantly higher (P < .001).,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ramezani Kermani', 'Affiliation': 'Nursing and Midwifery Care Research Center (Mr Kermani, Dr Aghebati, and Ms Mohajer), Department of Medical Surgical Nursing, School of Nursing and Midwifery (Mr kermani, Dr Aghebati, Ms Mohajer), and Department of Biostatistics, School of Health (Dr Ghavami), Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Aghebati', 'Affiliation': ''}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Mohajer', 'Affiliation': ''}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Ghavami', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000415']
2750,33060498,Effects of Acupressure on Preoperative Acute Anxiety in Cesarean Section Under Spinal Anesthesia: A Double-Blind Randomized Controlled Study.,"Anxiety during the preoperative period is a common problem experienced by women who will deliver by cesarean section. The use of nonpharmacological methods to control anxiety in pregnant women has been shown to be more appropriate. This double-blind randomized controlled experimental study was conducted to assess the effect of acupressure on acute anxiety developing before cesarean section under spinal anesthesia. In the present study, 82 pregnant women scheduled for surgery were randomly assigned to the acupressure and control groups including 40 and 42 persons, respectively. Acupressure was applied to HE-7 acupuncture points in the participants in the acupressure (intervention) group for 10 minutes before the surgery. The participants in the control group were subjected to the hospital protocol. Anxiety levels of the participating women were assessed twice preoperatively using the State-Trait Anxiety Inventory. Anxiety scores of the participants in the acupressure group before the procedure (49.13 ± 6.22) were higher than were those of the participants in the control group (41.71 ± 3.26); however, after the procedure, the anxiety scores decreased statistically significantly in the acupressure group (38.30 ± 4.45) compared with the control group (52.48 ± 7.30) (P < .001). Acupressure reduced the preoperative acute anxiety suffered by the participating pregnant women.",2020,"Anxiety scores of the participants in the acupressure group before the procedure (49.13 ± 6.22) were higher than were those of the participants in the control group (41.71 ± 3.26); however, after the procedure, the anxiety scores decreased statistically significantly in the acupressure group (38.30 ± 4.45) compared with the control group (52.48 ± 7.30) (P < .001).","['Cesarean Section Under Spinal Anesthesia', 'pregnant women', 'acute anxiety developing before cesarean section under spinal anesthesia', '82 pregnant women scheduled for surgery']","['Acupressure', 'acupressure']","['Anxiety scores', 'preoperative acute anxiety', 'anxiety scores', 'Anxiety levels', 'Preoperative Acute Anxiety', 'Anxiety']","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",82.0,0.102353,"Anxiety scores of the participants in the acupressure group before the procedure (49.13 ± 6.22) were higher than were those of the participants in the control group (41.71 ± 3.26); however, after the procedure, the anxiety scores decreased statistically significantly in the acupressure group (38.30 ± 4.45) compared with the control group (52.48 ± 7.30) (P < .001).","[{'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Kanza Gul', 'Affiliation': 'Medipol University School of Medicine Health, Istanbul, Turkey (Dr Kanza Gul); and Midwifery Department, Kirklareli University School of Health, Kirklareli, Turkey (Dr Solt Kirca).'}, {'ForeName': 'Ayça', 'Initials': 'A', 'LastName': 'Solt Kirca', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000413']
2751,33060497,The Effect of Foot Massage on Peripheral Neuropathy-Related Pain and Sleep Quality in Patients With Non-Hodgkin's Lymphoma.,"This study, which was conducted on patients with non-Hodgkin's lymphoma, aimed to evaluate the effect of foot massage on peripheral neuropathic pain and sleep quality. The survey was conducted between November 2018 and April 2019. Research data were collected through questionnaire, visual analogue scale (VAS), Douleur Neuropathique 4/Neuropathic Pain 4 (DN4) Questions, and Pittsburgh Sleep Quality Index. Classical foot massage was applied to participants in the intervention group, and they received 3 sessions a week, with each session lasting for 20 minutes over a period 4 weeks. After each massage session, pain levels were again assessed using the VAS and DN4 questionnaires. It has been shown that foot massage intervention reduces the patients' pain levels and has a positive effect on their sleep quality. Accordingly, foot massage can be recommended to patients with non-Hodgkin's lymphoma to reduce their peripheral neuropathy-related pain and improve their sleep quality.",2020,"Accordingly, foot massage can be recommended to patients with non-Hodgkin's lymphoma to reduce their peripheral neuropathy-related pain and improve their sleep quality.","[""patients with non-Hodgkin's lymphoma"", ""Patients With Non-Hodgkin's Lymphoma""]","['Classical foot massage', 'foot massage', 'Foot Massage']","['peripheral neuropathic pain and sleep quality', 'questionnaire, visual analogue scale (VAS), Douleur Neuropathique 4/Neuropathic Pain 4 (DN4) Questions, and Pittsburgh Sleep Quality Index', 'pain levels', 'Peripheral Neuropathy-Related Pain and Sleep Quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0458960', 'cui_str': 'Peripheral neuropathic pain'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}]",,0.018125,"Accordingly, foot massage can be recommended to patients with non-Hodgkin's lymphoma to reduce their peripheral neuropathy-related pain and improve their sleep quality.","[{'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Sarısoy', 'Affiliation': 'Gaziantep University Hospital, Gaziantep, Turkey (Ms Sarısoy); and Department of Nursing, Faculty of Health Science, Gaziantep University, Gaziantep, Turkey (Dr Ovayolu).'}, {'ForeName': 'Ozlem', 'Initials': 'O', 'LastName': 'Ovayolu', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000412']
2752,33060531,Avoiding the emergence of contrast-induced acute kidney injury in acute coronary syndrome: routine hydration treatment.,"BACKGROUND


Patients with acute coronary syndrome (ACS) have about a three-fold risk for developing contrast-induced acute kidney injury(CI-AKI). Investigating studies on routine hydration therapy have frequently included patients with stable coronary artery disease and high risk of CI-AKI [estimated glomerular filtration rate (eGFR) < 60 ml/min]. However, data on routine hydration treatment in non-ST segment elevation myocardial infarction (NSTEMI) patients with eGFR ≥60 ml/min are insufficient. We aimed to investigate the association between routine hydration therapy and CI-AKI development in NSTEMI patients at low risk for nephropathy.
METHODS AND RESULTS


We randomly assigned a total of 401 NSTEMI patients to two groups: the routine hydration group (198 patients) and the nonhydration group (control group) (203 patients). Intravenous hydration with isotonic saline (1 ml/kg/h, 0.9% sodium chloride) was given for 3-12 h before and 24 h after contrast exposure to the hydration group. CI-AKI was defined as the increase in serum creatinine values 0.5 mg/dl or 25% between 48 and 72 h after the invasive procedures. In our study, the incidence of CI-AKI development in the routine hydration group (7.1%) was significantly lower than in the nonhydration group (14.1%) (P: 0.02). This study revealed that older age, amount of contrast media, and routine hydration were independent risk factors for developing CI-AKI (P < 0.01, P: 0.04, P < 0.01, respectively).
CONCLUSION


We found that preprocedural and postprocedural intravenous hydration therapy reduces the development of CI-AKI in patients with NSTEMI at low risk for CI-AKI. We suggest administering routine hydration therapy in all ACS patients regardless of eGFR values.",2020,CI-AKI was defined as the increase in serum creatinine values 0.5 mg/dl or 25% between 48 and 72 h after the invasive procedures.,"['Patients with acute coronary syndrome (ACS', 'NSTEMI patients at low risk for nephropathy', 'patients with stable coronary artery disease and high risk of CI-AKI [estimated glomerular filtration rate (eGFR)\u2009<\u200960\u2009ml/min', 'acute coronary syndrome', 'non-ST segment elevation myocardial infarction (NSTEMI) patients with eGFR ≥60']","['routine hydration group', 'Intravenous hydration with isotonic saline (1\u2009ml/kg/h, 0.9% sodium chloride', 'nonhydration group (control group', 'routine hydration therapy']","['development of CI-AKI', 'serum creatinine values', 'incidence of CI-AKI development']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1532580', 'cui_str': 'mL/kg/hr'}, {'cui': 'C0990166', 'cui_str': 'Sodium Chloride 0.154 MEQ/ML'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",401.0,0.0246104,CI-AKI was defined as the increase in serum creatinine values 0.5 mg/dl or 25% between 48 and 72 h after the invasive procedures.,"[{'ForeName': 'Sukru', 'Initials': 'S', 'LastName': 'Arslan', 'Affiliation': 'Department of Cardiology, Cardiology Institute of Istanbul University-Cerrahpasa, Istanbul.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Yildiz', 'Affiliation': 'Department of Cardiology, Cardiology Institute of Istanbul University-Cerrahpasa, Istanbul.'}, {'ForeName': 'Yalcin', 'Initials': 'Y', 'LastName': 'Dalgic', 'Affiliation': 'Department of Cardiology, Health Sciences University Derince Training and Research Hospital, Kocaeli.'}, {'ForeName': 'Servet', 'Initials': 'S', 'LastName': 'Batit', 'Affiliation': 'Department of Cardiology, Kilis State Hospital, Kilis.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Kilicarslan', 'Affiliation': 'Department of Cardiology, Hakkari Yuksekova State Hospital, Hakkari.'}, {'ForeName': 'Ozgur Selim', 'Initials': 'OS', 'LastName': 'Ser', 'Affiliation': 'Department of Cardiology, Health Sciences University Şişli Hamidiye Etfal Training and Research Hospital.'}, {'ForeName': 'Sadiye Nur', 'Initials': 'SN', 'LastName': 'Dalgic', 'Affiliation': 'Department of Cardiology, Istanbul, Izmit Seka State Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Cuneyt', 'Initials': 'C', 'LastName': 'Kocas', 'Affiliation': 'Department of Cardiology, Cardiology Institute of Istanbul University-Cerrahpasa, Istanbul.'}, {'ForeName': 'Okay', 'Initials': 'O', 'LastName': 'Abaci', 'Affiliation': 'Department of Cardiology, Cardiology Institute of Istanbul University-Cerrahpasa, Istanbul.'}]",Coronary artery disease,['10.1097/MCA.0000000000000966']
2753,33060540,"Response to ""Biologic mesh implantation is associated with serious abdominal wall complications in patients undergoing emergency abdominal surgery - a randomized-controlled clinical trial.""",,2020,,['patients undergoing emergency abdominal surgery '],['Biologic mesh implantation'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",[],,0.208814,,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Martindale', 'Affiliation': 'Department of Surgery, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, L233A.'}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002991']
2754,33060615,Patient outcomes following GPs' educations about COPD: a cluster randomized controlled trial.,"This study aimed to compare patient outcomes following case method learning and traditional lectures as methods for continuing medical education (CME) about chronic obstructive pulmonary disease (COPD) for general practitioners (GPs) in Sweden. In a pragmatic cluster randomized controlled trial, COPD patients (n = 425; case method group n = 209, traditional lectures group n = 216) from 24 primary health care centers replied to questionnaires prior to and 18 months after a 2 × 2-h CME was given to GPs (n = 255). We measured changes in the scores of the Clinical COPD Questionnaire (CCQ), symptoms, needs for disease information, exacerbations, smoking, and use of pulmonary rehabilitation. The changes over time were similar for both CME methods. Patients who had used pulmonary rehabilitation increased from 13.2 to 17.8% (P = 0.04), and prevalence of smoking decreased from 28.9 to 25.1% (P = 0.003). In conclusion, neither of the used CME methods was superior than the other regarding patient outcomes. CME's primary value may lay in improving GPs' adherence to guidelines, which should lead to long-term positive changes in patient health.",2020,"Patients who had used pulmonary rehabilitation increased from 13.2 to 17.8% (P = 0.04), and prevalence of smoking decreased from 28.9 to 25.1% (P = 0.003).","['patients (n\u2009=\u2009425; case', 'continuing medical education (CME) about chronic obstructive pulmonary disease (COPD) for general practitioners (GPs) in Sweden']","[""GPs' educations about COPD"", 'method group n\u2009=\u2009209, traditional lectures group n\u2009=\u2009216) from 24 primary health care centers replied to questionnaires prior to and 18 months after a 2\u2009×\u20092-h CME was given to GPs', 'case method learning and traditional lectures', 'COPD']","['Clinical COPD Questionnaire (CCQ), symptoms, needs for disease information, exacerbations, smoking, and use of pulmonary rehabilitation', 'prevalence of smoking', 'pulmonary rehabilitation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0013632', 'cui_str': 'Continuing Medical Education'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C3266515', 'cui_str': 'Education about chronic obstructive pulmonary disease'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0013632', 'cui_str': 'Continuing Medical Education'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C2919593', 'cui_str': 'Clinical chronic obstructive pulmonary disease questionnaire'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",,0.169765,"Patients who had used pulmonary rehabilitation increased from 13.2 to 17.8% (P = 0.04), and prevalence of smoking decreased from 28.9 to 25.1% (P = 0.003).","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Sandelowsky', 'Affiliation': 'Karolinska Institutet, Department of Medicine, Division of Clinical Epidemiology, SE-171 76, Stockholm, Sweden. hanna.sandelowsky@ki.se.'}, {'ForeName': 'Ingvar', 'Initials': 'I', 'LastName': 'Krakau', 'Affiliation': 'Karolinska Institutet, Department of Medicine, Division of Clinical Epidemiology, SE-171 76, Stockholm, Sweden.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Modin', 'Affiliation': 'Karolinska Institutet, NVS, Section for Family Medicine and Primary Care, Alfred Nobels Allé 23, Huddinge, SE-141 83, Stockholm, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Ställberg', 'Affiliation': 'Uppsala University, Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine, Box 564, SE-751 22, Uppsala, Sweden.'}, {'ForeName': 'Sven-Erik', 'Initials': 'SE', 'LastName': 'Johansson', 'Affiliation': 'Lund University, Center for Primary Health Care Research, Department of Clinical Sciences, SE-205 02, Malmö, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nager', 'Affiliation': 'Karolinska Institutet, NVS, Section for Family Medicine and Primary Care, Alfred Nobels Allé 23, Huddinge, SE-141 83, Stockholm, Sweden.'}]",NPJ primary care respiratory medicine,['10.1038/s41533-020-00204-w']
2755,31855555,Developing a serocorrelate of protection against invasive group B streptococcus disease in pregnant women: a feasibility study.,"BACKGROUND


Group B streptococcus is the leading cause of infection in infants. Currently, intrapartum antibiotic prophylaxis is the major strategy to prevent invasive group B streptococcus disease. However, intrapartum antibiotic prophylaxis does not prevent maternal sepsis, premature births, stillbirths or late-onset disease. Maternal vaccination may offer an alternative strategy. Multivalent polysaccharide protein conjugate vaccine development is under way and a serocorrelate of protection is needed to expedite vaccine licensure.
OBJECTIVES


The ultimate aim of this work is to determine the correlate of protection against the major group B streptococcus disease-causing serotypes in infants in the UK. The aim of this feasibility study is to test key operational aspects of the study design.
DESIGN


Prospective cohort study of pregnant women and their infants in a 6-month period (1 July to 31 December 2018).
SETTING


Five secondary and tertiary hospitals from London and South England. National iGBS disease surveillance was conducted in all trusts in England and Wales.
PARTICIPANTS


Pregnant women aged ≥ 18 years who were delivering at one of the selected hospitals and who provided consent during the study period. There were no exclusion criteria.
INTERVENTIONS


No interventions were performed.
MAIN OUTCOME MEASURES


(1) To test the feasibility of collecting serum at delivery from a large cohort of pregnant women. (2) To test the key operational aspects for a proposed large serocorrelates study. (3) To test the feasibility of collecting samples from those with invasive group B streptococcus.
RESULTS


A total of 1823 women were recruited during the study period. Overall, 85% of serum samples were collected at three sites collecting only cord blood. At the two sites collecting maternal, cord and infant blood samples, the collection rate was 60%. A total of 614 women were screened for group B streptococcus with a colonisation rate of 22% (serotype distribution: 30% III, 25% Ia, 16% II, 14% Ib, 14% V and 1% IV). A blood sample was collected from 34 infants who were born to colonised women. Maternal and infant blood and the bacterial isolates for 15 newborns who developed invasive group B streptococcal disease during the study period were collected (serotype distribution: 29% III, 29% II, 21% Ia, 7% Ib, 7% IV and 7% V).
LIMITATIONS


Recruitment and sample collection were dependent on the presence of research midwives rather than the whole clinical team. In addition, individualised consent limited the number of women who could be approached each day, and site set-up for the national surveillance study and the limited time period of this feasibility study limited recruitment of all eligible participants.
CONCLUSIONS


We have verified the feasibility of collecting and processing rectovaginal swabs and blood samples in pregnant women, as well as samples from those with invasive group B streptococcal disease. We have made recommendations for the recruitment of cases within the proposed GBS3 study and for controls both within GBS3 and as an extension of this feasibility study.
FUTURE WORK


A large case-control study comparing specific immunoglobulin G levels in mothers whose infants develop invasive group B streptococcal disease with those in colonised mothers whose infants do not develop invasive group B streptococcal disease is recommended.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN49326091; IRAS project identification number 246149/REC reference number 18/WM/0147.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 67. See the NIHR Journals Library website for further project information.",2019,"A total of 614 women were screened for group B streptococcus with a colonisation rate of 22% (serotype distribution: 30% III, 25% Ia, 16% II, 14%","['infants in the UK', 'pregnant women', 'Five secondary and tertiary hospitals from London and South England', 'Pregnant women aged ≥\u200918 years who were delivering at one of the selected hospitals and who provided consent during the study period', 'pregnant women and their infants in a 6-month period (1 July to 31 December 2018', 'mothers whose infants develop invasive group B streptococcal disease with those in colonised mothers', '614 women', 'A total of 1823 women were recruited during the study period', '34 infants who were born to colonised women', '15 newborns who developed invasive group B streptococcal disease', 'infants']",[],"['colonisation rate', 'collection rate', 'maternal sepsis, premature births, stillbirths or late-onset disease', 'feasibility of collecting serum at delivery', 'Maternal and infant blood and the bacterial isolates']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}]",[],"[{'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C4704910', 'cui_str': 'Sepsis in Pregnancy'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0376415', 'cui_str': 'Late-Onset Disorders'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C3494793', 'cui_str': 'Bacterial isolate'}]",1823.0,0.102735,"A total of 614 women were screened for group B streptococcus with a colonisation rate of 22% (serotype distribution: 30% III, 25% Ia, 16% II, 14%","[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Carreras-Abad', 'Affiliation': ""Paediatric Infectious Diseases Research Group and Vaccine Institute, Institute of Infection and Immunity, St George's, University of London, London, UK.""}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Cochet', 'Affiliation': ""Paediatric Infectious Diseases Research Group and Vaccine Institute, Institute of Infection and Immunity, St George's, University of London, London, UK.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Hall', 'Affiliation': ""Paediatric Infectious Diseases Research Group and Vaccine Institute, Institute of Infection and Immunity, St George's, University of London, London, UK.""}, {'ForeName': 'Laxmee', 'Initials': 'L', 'LastName': 'Ramkhelawon', 'Affiliation': ""Paediatric Infectious Diseases Research Group and Vaccine Institute, Institute of Infection and Immunity, St George's, University of London, London, UK.""}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Khalil', 'Affiliation': ""Department of Obstetrics and Gynaecology, St George's University Hospitals NHS Foundation Trust, London, UK.""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Peregrine', 'Affiliation': 'Department of Obstetrics and Gynaecology, Kingston Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Latha', 'Initials': 'L', 'LastName': 'Vinayakarao', 'Affiliation': 'Department of Obstetrics and Gynaecology, Poole Hospital NHS Foundation Trust, Poole, UK.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Sivarajan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Surrey and Sussex Healthcare NHS Trust, Redhill, UK.'}, {'ForeName': 'Rosol', 'Initials': 'R', 'LastName': 'Hamid', 'Affiliation': 'Department of Obstetrics and Gynaecology, Croydon Health Services NHS Trust, Croydon, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Planche', 'Affiliation': ""Microbiology Department, St George's University Hospitals NHS Foundation Trust, London, UK.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sheridan', 'Affiliation': 'Microbiology Department, Poole Hospital NHS Foundation Trust, Poole, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Winchester', 'Affiliation': 'Microbiology Department, Surrey and Sussex Healthcare NHS Trust, Redhill, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Plumb', 'Affiliation': 'Group B Strep Support Group, Haywards Heath, UK.'}, {'ForeName': 'Abdelmajid', 'Initials': 'A', 'LastName': 'Djennad', 'Affiliation': 'Statistics, Modelling and Economics Department, National Infection Service, Public Health England, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Andrews', 'Affiliation': 'Statistics, Modelling and Economics Department, National Infection Service, Public Health England, London, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Le Doare', 'Affiliation': ""Paediatric Infectious Diseases Research Group and Vaccine Institute, Institute of Infection and Immunity, St George's, University of London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Heath', 'Affiliation': ""Paediatric Infectious Diseases Research Group and Vaccine Institute, Institute of Infection and Immunity, St George's, University of London, London, UK.""}]","Health technology assessment (Winchester, England)",['10.3310/hta23670']
2756,33063961,[Antiangiogenic therapy in the surgical treatment of pterygium].,"PURPOSE


To evaluate the effectiveness and safety of adjuvant anti-VEGF therapy in the surgical treatment of pterygium, and to determine the indications for its use.
MATERIAL AND METHODS


The study included 67 patients (69 eyes) with grade II-IV pterygium. Patients age was 58.8±12.6 years on average. Best corrected visual acuity (BCVA) varied between 0.01 and 1.0 (0.77±0.24). The patients were divided into 3 groups. The first group included 19 patients (19 eyes) with grade II-III pterygium who underwent «bare sclera» surgery and used aflibercept as adjuvant therapy. The second group included 21 patients (21 eyes) with grade II-IV pterygium who underwent auto conjunctival grafting surgery with no adjuvant therapy. The third group included 27 patients (29 eyes) with grade II-IV pterygium who had it removed in combination with single-time peripheral lamellar keratoplasty (PLK) and underwent adjuvant aflibercept therapy.
RESULTS


Among patients who underwent pterygium excision with adjuvant antiangiogenic therapy there were 5 cases (26%) of relapse during the observation period (23.38±8.96 months), among patients after pterygium excision with auto conjunctival plastic surgery - also 5 cases (24%) of relapse, and among patients who underwent LKP combined with anti-VEGF therapy there was only 1 case (3%) of relapse. Astigmatism has decreased by 0.24±0.5 ( p =0.052) in the first group, by 1.21±1.0 ( p <0.05) in the second group, and by 1.64±1.54 ( p <0.05) in the third group compared with pre-surgical values, thus increasing average BCVA in all 3 patient groups by 0.1±0.13, 0.07±0.11 and 0.15±0.15, respectively.
CONCLUSION


The use of anti-VEGF agents as adjuvant therapy in the surgical treatment of pterygium is a safe method of reducing postoperative inflammation, fibrovascular proliferation and, subsequently, the amount of relapses.",2020,"Astigmatism has decreased by 0.24±0.5 ( p =0.052) in the first group, by 1.21±1.0 ( p <0.05) in the second group, and by 1.64±1.54 ( p <0.05) in the third group compared with pre-surgical values, thus increasing average BCVA in all 3 patient groups by 0.1±0.13, 0.07±0.11 and 0.15±0.15, respectively.
","['67 patients (69 eyes) with grade II-IV pterygium', 'Patients age was 58.8±12.6 years on average', '21 patients (21 eyes) with grade II-IV pterygium who underwent', '19 patients (19 eyes) with grade II-III pterygium who underwent «bare sclera» surgery and used', '27 patients (29 eyes) with grade II-IV pterygium who had it removed in combination with single-time peripheral lamellar keratoplasty (PLK) and underwent adjuvant aflibercept therapy']","['anti-VEGF agents', 'adjuvant anti-VEGF therapy', 'Antiangiogenic therapy', 'aflibercept as adjuvant therapy', 'LKP combined with anti-VEGF therapy', 'pterygium excision with adjuvant antiangiogenic therapy', 'auto conjunctival grafting surgery with no adjuvant therapy']","['Best corrected visual acuity (BCVA', 'average BCVA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0036410', 'cui_str': 'Scleral structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0022591', 'cui_str': 'Lamellar keratoplasty'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C4727874', 'cui_str': 'Anti-VEGF therapy'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0197133', 'cui_str': 'Simple excision of pterygium'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]",67.0,0.0129914,"Astigmatism has decreased by 0.24±0.5 ( p =0.052) in the first group, by 1.21±1.0 ( p <0.05) in the second group, and by 1.64±1.54 ( p <0.05) in the third group compared with pre-surgical values, thus increasing average BCVA in all 3 patient groups by 0.1±0.13, 0.07±0.11 and 0.15±0.15, respectively.
","[{'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Malozhen', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Trufanov', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Krakhmaleva', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}]",Vestnik oftalmologii,['10.17116/oftalma2020136052177']
2757,33064011,Factors Predictive of Outcome in Inferior Turbinate Surgery.,"OBJECTIVES


The purpose of the study was to examine the various preoperative predictive factors of inferior turbinate surgery and to find possible factors that predict an optimal subjective response using 3 common surgical techniques-radiofrequency ablation (RFA), diode laser, and microdebrider-assisted inferior turbinoplasty (MAIT)-in a randomized, prospective study with a 1-year follow-up.
METHODS


The patients filled a visual analogue scale (VAS) questionnaire regarding the severity of nasal obstruction prior to and 1 year after surgery. A VAS score improvement of 3 points or more was chosen as an optimal subjective response. Univariate and multivariate regressions were used to evaluate the effect of the predictive factors. In total, 80 patients attended a 1-year control visit.
RESULTS


In the multivariate analysis, patients without anterior septal deviation had a statistically significantly higher odds ratio of a satisfactory subjective response compared to patients with anterior septal deviation (5.6; 95% CI: 1.4-23.1;  P  = .02). Patients treated with RFA had a statistically significantly higher odds ratio of an optimal subjective response compared to patients treated with MAIT (9.0; 95% CI: 1.5-54.2;  P  = .02).
CONCLUSIONS


Anterior septal deviation seems to decrease the likelihood of an optimal subjective response to inferior turbinate surgery, which supports the consideration of concomitant septoplasty at least in clear cases to optimize the subjective response. Radiofrequency ablation had a significantly higher likelihood of an optimal subjective response compared to MAIT. Further investigations regarding the findings are needed.",2020,"Patients treated with RFA had a statistically significantly higher odds ratio of an optimal subjective response compared to patients treated with MAIT (9.0; 95% CI: 1.5-54.2;  P  = .02).
",['80 patients attended a 1-year control visit'],"['3 common surgical techniques-radiofrequency ablation (RFA), diode laser, and microdebrider-assisted inferior turbinoplasty', 'Radiofrequency ablation', 'RFA']","['odds ratio of an optimal subjective response', 'visual analogue scale (VAS) questionnaire regarding the severity of nasal obstruction', 'satisfactory subjective response', 'optimal subjective response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C4087115', 'cui_str': 'Turbinoplasty'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}]",80.0,0.0344595,"Patients treated with RFA had a statistically significantly higher odds ratio of an optimal subjective response compared to patients treated with MAIT (9.0; 95% CI: 1.5-54.2;  P  = .02).
","[{'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Harju', 'Affiliation': 'Department of Otorhinolaryngology, 60670Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Jura', 'Initials': 'J', 'LastName': 'Numminen', 'Affiliation': 'Department of Otorhinolaryngology, 60670Tampere University Hospital, Tampere, Finland.'}]","Ear, nose, & throat journal",['10.1177/0145561320966066']
2758,33064039,Auditory and visual distraction improve muscle endurance: a randomised controlled trial.,"The main aim was to investigate the influence of various distracting stimuli on the endurance-strength and fatigue of the lumbar region in asymptomatic participants. Fifty-four healthy individuals were randomised to three groups: auditory distraction group (ADG), visual distraction group (VDG) and control group without distraction (CG). Lumbar muscle endurance and perceived fatigue were the outcome measures. Lumbar muscle endurance was assessed with the Biering-Sorensen test, and perceived fatigue was assessed with the modified Borg scale, once baseline and second with the distraction intervention. Lumbar muscle endurance showed significant changes over time, and there were intragroup differences for VDG and ADG. The direct comparison did show significant differences between both distraction groups with respect to the control group with a large effect size (ΔVDG-CG:  p  < 0.001,  d  = 1.55 and, ΔADG-CG:  p  = 0.008,  d  = 1.07) but not between the two distraction groups (ΔVDG-VDG:  p  = 0.56). Fatigue showed significant changes over time but not for group*time interaction, revealing intragroup differences for VDG and ADG. There were no intragroup differences in the CG for muscle resistance or fatigue, and there were no between-group differences. Auditory and visual distractors might produce a significant increase in muscle resistance during the Biering-Sorensen test. Both techniques are valid for increasing lumbar muscle endurance but also both stimuli produced a higher level of fatigue or perception of effort once the test was completed when compared with CG. Finally, we were unable to demonstrate that one type of stimulus produces superior results to the other.",2020,Both techniques are valid for increasing lumbar muscle endurance but also both stimuli produced a higher level of fatigue or perception of effort once the test was completed when compared with CG.,"['asymptomatic participants', 'Fifty-four healthy individuals']","['Auditory and visual distraction', 'auditory distraction group (ADG), visual distraction group (VDG) and control group without distraction (CG']","['Lumbar muscle endurance and perceived fatigue', 'muscle resistance', 'lumbar muscle endurance', 'muscle endurance', 'muscle resistance or fatigue', 'Lumbar muscle endurance']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",54.0,0.0270395,Both techniques are valid for increasing lumbar muscle endurance but also both stimuli produced a higher level of fatigue or perception of effort once the test was completed when compared with CG.,"[{'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Grande-Alonso', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ortega-López', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Vittecoq', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Mayo-Fernández', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Navarro-Fernández', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Cuenca-Martínez', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'La Touche', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Paris-Alemany', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}]",Somatosensory & motor research,['10.1080/08990220.2020.1834378']
2759,33064057,Efficacy and Safety of Aqueous Interleukin-8-Guided Treatment in Cytomegalovirus Retinitis after Bone Marrow Hematopoietic Stem Cell Transplantation.,"PURPOSE


To explore the optimal treatment for cytomegalovirus retinitis (CMVR) in patients status-post Allogeneic bone marrow hematopoietic stem cell transplantation (Allo-HSCT), based on aqueous humor indicators.
METHODS


A randomized controlled study with 35 eyes. Eyes were randomized with a 1:1 ratio to standard treatment group (Group 1, with treatment endpoint as aqueous CMV-DNA load＜103 copy/ml), and interleukin (IL)-8 group (Group 2, with treatment endpoint as aqueous IL-8 level ＜30 pg/ml or CMV-DNA load＜103 copy/ml) to receive antiviral intravitreal injections. Number of injections, CMVR recurrence rate, complication rate, and vision changes were analyzed and compared.
RESULTS


The mean number of injections in group 2 was less than in group 1 (6 vs 8 respectively,  p <0.05). There were no significant differences in CMVR recurrence, complication and vision recovery rate.
CONCLUSION


Incorporating aqueous humor IL-8 level into the criteria of CMVR treatment decision can safely and effectively reduce the number of intravitreal injections needed and can be used as important indicators to assess treatment endpoint.",2020,"The mean number of injections in group 2 was less than in group 1 (6 vs 8 respectively,  p <0.05).","['Cytomegalovirus Retinitis after Bone Marrow Hematopoietic Stem Cell Transplantation', '35 eyes', 'cytomegalovirus retinitis (CMVR) in patients status-post Allogeneic bone marrow hematopoietic stem cell transplantation (Allo-HSCT']","['antiviral intravitreal injections', 'aqueous CMV-DNA load＜103 copy/ml), and interleukin (IL)-8 group (Group 2, with treatment endpoint as aqueous IL-8 level ＜30 pg/ml or CMV-DNA', 'Aqueous Interleukin-8-Guided Treatment']","['Number of injections, CMVR recurrence rate, complication rate, and vision changes', 'mean number of injections', 'CMVR recurrence, complication and vision recovery rate', 'Efficacy and Safety']","[{'cui': 'C0206178', 'cui_str': 'Cytomegaloviral retinitis'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0449437', 'cui_str': 'Patient status'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0369083', 'cui_str': 'Cytomegalovirus DNA'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0206178', 'cui_str': 'Cytomegaloviral retinitis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",35.0,0.0661497,"The mean number of injections in group 2 was less than in group 1 (6 vs 8 respectively,  p <0.05).","[{'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Department of Ophthalmology & Clinical Centre of Optometry, Peking University People's Hospital, Eye Diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroidal Diseases, College of Optometry, Peking University Health Science Center , Beijing, China.""}, {'ForeName': 'Ye Elaine', 'Initials': 'YE', 'LastName': 'Wang', 'Affiliation': 'Harvard Eye Associates, Private Practice , Laguna Hills, CA, USA.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Miao', 'Affiliation': ""Department of Ophthalmology & Clinical Centre of Optometry, Peking University People's Hospital, Eye Diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroidal Diseases, College of Optometry, Peking University Health Science Center , Beijing, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': ""Department of Ophthalmology & Clinical Centre of Optometry, Peking University People's Hospital, Eye Diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroidal Diseases, College of Optometry, Peking University Health Science Center , Beijing, China.""}]",Ocular immunology and inflammation,['10.1080/09273948.2020.1823422']
2760,33064299,Inosine 5'-Monophosphate to Raise Serum Uric Acid Level in Multiple System Atrophy (IMPROVE-MSA study).,"The aim of this trial was to investigate the safety, tolerability, and capability of serum uric acid (UA) elevation of inosine 5'-monophosphate (IMP) in multiple system atrophy (MSA). The IMPROVE-MSA trial was a randomized, double-blind, placebo-controlled trial in MSA patients with no history of hyperuricemia-related disorders. The participants were assigned to placebo (n=25) or IMP (n=30) in a 1 to 1 ratio, and then followed up for 24 weeks. The primary endpoints included safety, tolerability, and alteration of the serum UA level during the follow-up period. The secondary endpoints were changes in scores of the unified MSA rating scale (UMSARS) and the Mini-Mental Status Examination (MMSE) and Montreal Cognitive Assessment (MoCA). The total number of adverse events (AE) and serious AE was comparable between the active and placebo groups. Serum UA level (mg/dL) was significantly increased from baseline (active vs placebo, 4.57 vs 4.58; p = 0.98) to study endpoint (6.96 vs 4.43; p <0.001) in the active group compared to the placebo group (time × group interaction; p <0.001). The change in UMSARS scores did not differ between the active and placebo groups. However, the active group showed significantly better alterations in MoCA scores with nominal significance (p <0.001) and tendency for better alterations in MMSE scores (p = 0.09) than the placebo group. Our data demonstrated that IMP treatment was generally safe and well tolerated in patients with MSA. Further trial with a long-term follow-up is are required to examine whether UA elevation will slow clinical progression in early MSA.",2020,"However, the active group showed significantly better alterations in MoCA scores with nominal significance (p <0.001) and tendency for better alterations in MMSE scores (p = 0.09) than the placebo group.","['MSA patients with no history of hyperuricemia-related disorders', 'patients with MSA']","[""Inosine 5'-Monophosphate"", 'placebo', 'IMP']","['total number of adverse events (AE) and serious AE', 'Serum UA level', 'UMSARS scores', 'MoCA scores', ""safety, tolerability, and capability of serum uric acid (UA) elevation of inosine 5'-monophosphate (IMP"", 'safe and well tolerated', 'changes in scores of the unified MSA rating scale (UMSARS) and the Mini-Mental Status Examination (MMSE) and Montreal Cognitive Assessment (MoCA', 'safety, tolerability, and alteration of the serum UA level', 'MMSE scores']","[{'cui': 'C0393571', 'cui_str': 'Multiple system atrophy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0021528', 'cui_str': 'Inosine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0000294', 'cui_str': 'Mesna'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0021528', 'cui_str': 'Inosine'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0393571', 'cui_str': 'Multiple system atrophy'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}]",,0.442729,"However, the active group showed significantly better alterations in MoCA scores with nominal significance (p <0.001) and tendency for better alterations in MMSE scores (p = 0.09) than the placebo group.","[{'ForeName': 'Jae Jung', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.'}, {'ForeName': 'Jung Han', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Neurology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Sang Jin', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.'}, {'ForeName': 'Han Soo', 'Initials': 'HS', 'LastName': 'Yoo', 'Affiliation': 'Department of Neurology, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seok Jong', 'Initials': 'SJ', 'LastName': 'Chung', 'Affiliation': 'Department of Neurology, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yang Hyun', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Suk Yun', 'Initials': 'SY', 'LastName': 'Kang', 'Affiliation': 'Department of Neurology, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea.'}, {'ForeName': 'Hae-Won', 'Initials': 'HW', 'LastName': 'Shin', 'Affiliation': 'Department of Neurology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sook Keun', 'Initials': 'SK', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Jeju National University School of Medicine, Jeju, Korea.'}, {'ForeName': 'Jin Yong', 'Initials': 'JY', 'LastName': 'Hong', 'Affiliation': 'Department of Neurology, Yonsei University Wonju College of Medicine, Wonju, Korea.'}, {'ForeName': 'MunKyung', 'Initials': 'M', 'LastName': 'Sunwoo', 'Affiliation': 'Department of Neurology, Bundang Jesaeng General Hospital, Seongnam, Korea.'}, {'ForeName': 'Ji Eun', 'Initials': 'JE', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, National Health Insurance Service Ilsan Hospital, Goyang, Korea.'}, {'ForeName': 'Jong Sam', 'Initials': 'JS', 'LastName': 'Baik', 'Affiliation': 'Department of Neurology, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young H', 'Initials': 'YH', 'LastName': 'Sohn', 'Affiliation': 'Department of Neurology, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Phil Hyu', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Yonsei University College of Medicine, Seoul, Korea.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2082']
2761,33064358,Health promotion intervention for people with early-stage dementia: A quasi-experimental study.,"INTRODUCTION


With the limited advancements in medical treatment, there is a growing need for supporting people with early-stage dementia adjust to their diagnosis and improve their quality of life. This study aimed to investigate the effects of a 12-week health promotion course for people with early-stage dementia.
METHODS


Quasi-experimental, single group, pretest-posttest design. A total of 108 persons with dementia participated in this study, and for each participant, a carer was interviewed. The 12-week health promotion intervention consisted of 2-hr sessions at weekly intervals. Outcome measures were cognition, measured by Mini-Mental State Examination, personal, and instrumental activities of daily living (P-ADL and I-ADL), measured by Lawton and Brody's Physical Self-Maintenance Scale and Instrumental Activities of Daily Living Scale, self-rated health, measured by the European Quality of life Visual Analogue Scale, depressive symptoms, measured by the Cornell Scale for Depression in Dementia, and neuropsychiatric symptoms, measured by The Neuropsychiatric Inventory. Assessments were conducted at baseline and at follow-up 1-2 months postintervention.
RESULTS


The results demonstrate a small but statistically significant improvement in depressive symptoms (p = .015) and in self-rated health (p = .031). The results also demonstrated a small statistically significant decline in the participants' I-ADL (p = .007). The participants' cognitive function, P-ADL, and neuropsychiatric symptoms were stable during the 4-month follow-up.
CONCLUSION


This study demonstrates promising results with regard to the benefit of attending a 12-week health promotion intervention in promoting health and well-being in people with early-stage dementia. With the majority of participants with early-stage dementia living at home without any healthcare services in a vulnerable stage of the condition, this study makes an important contribution to highlighting the need for, and benefit of, educational approaches for this population.",2020,The results also demonstrated a small statistically significant decline in the participants' I-ADL (p = .007).,"['participants with early-stage dementia living at home without any healthcare services', '108 persons with dementia participated in this study, and for each participant, a carer was interviewed', 'people with early-stage dementia']","['health promotion intervention', 'Health promotion intervention']","[""cognition, measured by Mini-Mental State Examination, personal, and instrumental activities of daily living (P-ADL and I-ADL), measured by Lawton and Brody's Physical Self-Maintenance Scale and Instrumental Activities of Daily Living Scale, self-rated health, measured by the European Quality of life Visual Analogue Scale, depressive symptoms, measured by the Cornell Scale for Depression in Dementia, and neuropsychiatric symptoms, measured by The Neuropsychiatric Inventory"", 'depressive symptoms', 'cognitive function, P-ADL, and neuropsychiatric symptoms', 'self-rated health']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0557829', 'cui_str': 'Healthcare services'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C1275588', 'cui_str': 'Physical self maintenance scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",108.0,0.0456782,The results also demonstrated a small statistically significant decline in the participants' I-ADL (p = .007).,"[{'ForeName': 'Ingelin', 'Initials': 'I', 'LastName': 'Testad', 'Affiliation': 'Centre for Age-related Medicine - SESAM, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Kajander', 'Affiliation': 'Centre for Age-related Medicine - SESAM, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Martha T', 'Initials': 'MT', 'LastName': 'Gjestsen', 'Affiliation': 'Centre for Age-related Medicine - SESAM, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Ingvild', 'Initials': 'I', 'LastName': 'Dalen', 'Affiliation': 'Department of Research, Section of Biostatistics, Stavanger University Hospital, Stavanger, Norway.'}]",Brain and behavior,['10.1002/brb3.1888']
2762,33064385,Drain Placement After Uncomplicated Hepatic Resection Increases Severe Postoperative Complication Rate: A Japanese Multi-institutional Randomized Controlled Trial (ND-trial).,"OBJECTIVE


To assess the clinical impact of a no-drain policy after hepatic resection.
SUMMARY OF BACKGROUND DATA


Previous randomized controlled trials addressing no-drain policy after hepatic resection seem inconclusive because they did not adopt appropriate study design to validate its true clinical impact.
METHODS


This unblinded, randomized controlled trial was done at 7 Japanese institutions. Patients undergoing hepatic resection without biliary reconstruction were randomized to either D group or ND group. When the risk of postoperative bile leakage or hemorrhage were considered high, the patients were excluded during the operation. Primary endpoint was the postoperative complication of C-D grade 3 or higher within 90 postoperative days. A noninferiority of ND group to D group was assessed, and if it was confirmed, a superiority was assessed.
RESULTS


Between May 2015 and July 2017, a total of 400 patients were finally included in the per-protocol set analysis: 199 patients in D group and 201 patients in ND group. Intraoperatively, 37 patients were excluded from the final enrollment because of high risk of bile leakage or hemorrhage. Postoperative complication rate of C-D grade 3 or higher was 8.0% (16/199) in the D group and 2.5% (5/201) in the ND group. The risk difference was -5.5% (95% confidence interval: -9.9% to -1.2%) and fulfilled the prescribed noninferiority margin of 4%. No postoperative mortality was experienced in both groups. Bile leakage was diagnosed in 8.0% (16/199) of the D group and none in the ND group (P < 0.001). In none of the subgroups classified based on 8 potentially relevant factors, drain placement was favored in terms of C-D grade 3 or higher complication.
CONCLUSIONS


Drains should not be placed after uncomplicated hepatic resections.",2020,Bile leakage was diagnosed in 8.0% (16/199) of the D group and none in the ND group (P < 0.001).,"['37 patients were excluded from the final enrollment because of high risk of bile leakage or hemorrhage', '7 Japanese institutions', 'Patients undergoing hepatic resection without biliary reconstruction', 'Between May 2015 and July 2017, a total of 400 patients were finally included in the per-protocol set analysis: 199 patients in D group and 201 patients in ND group']","['Uncomplicated Hepatic Resection', 'Drain Placement']","['postoperative complication of C-D grade 3 or higher within 90 postoperative days', 'Severe Postoperative Complication Rate', 'postoperative mortality', 'Postoperative complication rate of C-D grade 3 or higher', 'postoperative bile leakage or hemorrhage', 'Bile leakage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0400997', 'cui_str': 'Leakage of bile'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C3495845', 'cui_str': 'Drain placement'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0012358', 'cui_str': 'Dilation and curettage of uterus'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0400997', 'cui_str': 'Leakage of bile'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",400.0,0.347905,Bile leakage was diagnosed in 8.0% (16/199) of the D group and none in the ND group (P < 0.001).,"[{'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Arita', 'Affiliation': '*Hepato-Biliary and Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan †Center for Data Science, Yokohama City University, Yokohama, Japan ‡Department of Gastrointestinal Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan §Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital East, Chiba, Japan ¶Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Kyorin University School of Medicine, Tokyo, Japan ||Hepato-Biliary-Pancreatic Surgery Division, Department of Gastroenterological Surgery, Toranomon Hospital, Tokyo, Japan **Department of Surgery, Division of Gastroenterological Surgery, Aichi Medical University, Nagakute, Japan ††Division of Hepato-Biliary-Pancreatic Surgery, Shizuoka Cancer Center, Shizuoka, Japan ‡‡National Center for Global Health and Medicine, Tokyo, Japan §§Department of Biostatistics, School of Medicine, Yokohama City University, Yokohama, Japan ¶¶Hepatobiliary and Pancreatic Surgery Division, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kentarou', 'Initials': 'K', 'LastName': 'Sakamaki', 'Affiliation': ''}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Saiura', 'Affiliation': ''}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Konishi', 'Affiliation': ''}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Sakamoto', 'Affiliation': ''}, {'ForeName': 'Masaji', 'Initials': 'M', 'LastName': 'Hashimoto', 'Affiliation': ''}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Sano', 'Affiliation': ''}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Uesaka', 'Affiliation': ''}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kokudo', 'Affiliation': ''}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': ''}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Shimada', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004051']
2763,33064386,Surgeon Quality Control and Standardization of D2 Lymphadenectomy for Gastric Cancer: A Prospective Multicenter Observational Study (KLASS-02-QC).,"OBJECTIVE


To qualify surgeons to participate in a randomized trial comparing laparoscopic and open distal D2 gastrectomy for advanced gastric cancer.
SUMMARY OF BACKGROUND DATA


No studies have sought to qualify surgeons for a randomized trial comparing laparoscopic and open D2 gastrectomy for advanced gastric cancer.
METHODS


We conducted a multicenter prospective observational study evaluating unedited videos of laparoscopic and open D2 gastrectomy performed by 27 surgeons. Surgeons performed 3 of each laparoscopic and open distal gastrectomies with D2 lymphadenectomy for gastric cancer. Five peers reviewed each unedited video using a video assessment form. Based on experts' review of videos, a separate review committee decided surgeons as ""Qualified"" or ""Not-qualified.""
RESULTS


Twelve surgeons (44.4%) were qualified on initial evaluation whereas the other 15 surgeons were not. Another 9 surgeons were finally qualified after re-evaluation. The median score for Qualified was significantly higher than Not-qualified (P < 0.001).Significant differences between Qualified and Not-qualified were noted both in operation type and in all evaluation area of surgical skill, perigastric, and extra-perigastric lymphadenectomy, although the inter-rater variability of the assessment score was low (kappa = 0.285). However, Not-qualified surgeons' scores improved upon re-evaluation of resubmitted videos.When compared laparoscopy with open surgery, median scores were similar between the 2 groups (P = 0.680). However, open gastrectomy scores for surgical skills were significantly higher than for laparoscopic surgery (P = 0.016).
CONCLUSIONS


Our surgeon quality control study for gastrectomy represents a milestone in surgical standardization for surgical clinical trials. Our methods could also serve as a system for educating surgeons and assessing surgical proficiency.",2020,"However, open gastrectomy scores for surgical skills were significantly higher than for laparoscopic surgery (P = 0.016).
","['27 surgeons', 'Twelve surgeons (44.4%) were qualified on initial evaluation whereas the other 15 surgeons were not', 'advanced gastric cancer', 'Gastric Cancer', 'gastric cancer']","['laparoscopic and open distal D2 gastrectomy', 'laparoscopic and open distal gastrectomies with D2 lymphadenectomy', 'D2 Lymphadenectomy', 'laparoscopic and open D2 gastrectomy', 'unedited videos of laparoscopic and open D2 gastrectomy']","['open gastrectomy scores for surgical skills', 'median score for Qualified', 'median scores']","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",5.0,0.0486473,"However, open gastrectomy scores for surgical skills were significantly higher than for laparoscopic surgery (P = 0.016).
","[{'ForeName': 'Sang-Uk', 'Initials': 'SU', 'LastName': 'Han', 'Affiliation': ""*Department of Surgery, Ajou University School of Medicine, Suwon, Republic of Korea †Department of Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea ‡Department of Surgery, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea §Department of Surgery, Dong-A University College of Medicine, Busan, Republic of Korea ¶Department of Surgery, Chonnam National University Hwasun Hospital, Hwasun, Republic of Korea ||Department of Surgery, Yeouido St. Mary's Hospital, The Catholic University of Korea, College of Medicine, Seoul, Republic of Korea **Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.""}, {'ForeName': 'Hoon', 'Initials': 'H', 'LastName': 'Hur', 'Affiliation': ''}, {'ForeName': 'Hyuk-Joon', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Gyu Seok', 'Initials': 'GS', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'Min-Chan', 'Initials': 'MC', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Young Kyu', 'Initials': 'YK', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Wook', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Woo Jin', 'Initials': 'WJ', 'LastName': 'Hyung', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000003883']
2764,33055113,Intermittent antegrade warm-blood versus cold-blood cardioplegia in children undergoing open heart surgery: a protocol for a randomised controlled study (Thermic-3).,"INTRODUCTION


Surgical repair of congenital heart defects often requires the use of cardiopulmonary bypass (CPB) and cardioplegic arrest. Cardioplegia is used during cardiac surgery requiring CPB to keep the heart still and to reduce myocardial damage as a result of ischaemia-reperfusion injury. Cold cardioplegia is the prevalent method of myocardial protection in paediatric patients; however, warm cardioplegia is used as part of usual care throughout the UK in adults. We aim to provide evidence to support the use of warm versus cold blood cardioplegia on clinical and biochemical outcomes during and after paediatric congenital heart surgery.
METHODS AND ANALYSIS


We are conducting a single-centre randomised controlled trial in paediatric patients undergoing operations requiring CPB and cardioplegic arrest at the Bristol Royal Hospital for Children. We will randomise participants in a 1:1 ratio to receive either 'cold-blood cardioplegia' or 'warm-blood cardioplegia'. The primary outcome will be the difference between groups with respect to Troponin T levels over the first 48 postoperative hours. Secondary outcomes will include measures of cardiac function; renal function; cerebral function; arrythmias during and postoperative hours; postoperative blood loss in the first 12 hours; vasoactive-inotrope score in the first 48 hours; intubation time; chest and wound infections; time from return from theatre until fit for discharge; length of postoperative hospital stay; all-cause mortality to 3 months postoperative; myocardial injury at the molecular and cellular level.
ETHICS AND DISSEMINATION


This trial has been approved by the London - Central Research Ethics Committee. Findings will be disseminated to the academic community through peer-reviewed publications and presentation at national and international meetings. Patients will be informed of the results through patient organisations and newsletters to participants.
TRIAL REGISTRATION NUMBER


ISRCTN13467772; Pre-results.",2020,We are conducting a single-centre randomised controlled trial in paediatric patients undergoing operations requiring CPB and cardioplegic arrest at the Bristol Royal Hospital for Children.,"['paediatric patients undergoing operations requiring CPB and cardioplegic arrest at the Bristol Royal Hospital for Children', 'paediatric patients', 'children undergoing open heart surgery']","['warm versus cold blood cardioplegia', 'Intermittent antegrade warm-blood versus cold-blood cardioplegia', 'Cold cardioplegia', ""cold-blood cardioplegia' or 'warm-blood cardioplegia"", 'Cardioplegia', 'cardiopulmonary bypass (CPB']","['Troponin T levels', 'measures of cardiac function; renal function; cerebral function; arrythmias during and postoperative hours; postoperative blood loss in the first 12\u2009hours; vasoactive-inotrope score in the first 48\u2009hours; intubation time; chest and wound infections; time from return from theatre until fit for discharge; length of postoperative hospital stay; all-cause mortality to 3 months postoperative; myocardial injury at the molecular and cellular level']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C0522789', 'cui_str': 'Cryocardioplegia'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0234386', 'cui_str': 'Cerebral function'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0475307', 'cui_str': 'Theatre'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}]",,0.18115,We are conducting a single-centre randomised controlled trial in paediatric patients undergoing operations requiring CPB and cardioplegic arrest at the Bristol Royal Hospital for Children.,"[{'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Heys', 'Affiliation': 'Bristol Trials Centre, Clincal Trials and Evaulation Unit, Bristol Medical School, University of Bristol, Bristol, UK rh13369@bristol.ac.uk.'}, {'ForeName': 'Serban', 'Initials': 'S', 'LastName': 'Stoica', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Angelini', 'Affiliation': 'National Institute for Health Research Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust and University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beringer', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Evans', 'Affiliation': 'Bristol Trials Centre, Clincal Trials and Evaulation Unit, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ghorbel', 'Affiliation': 'Bristol Heart Institue, University of Bristol, Bristol, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Lansdowne', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Parry', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Pieles', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Barnaby', 'Initials': 'B', 'LastName': 'Reeves', 'Affiliation': 'Bristol Trials Centre, Clincal Trials and Evaulation Unit, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Bristol Trials Centre, Clincal Trials and Evaulation Unit, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Saxena', 'Affiliation': 'Cardiac Intensive Care, Great Ormond Street Hospital For Children NHS Foundation Trust, London, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sheehan', 'Affiliation': 'National Institute for Health Research Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust and University of Bristol, Bristol, UK.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Terrie', 'Initials': 'T', 'LastName': 'Walker-Smith', 'Affiliation': 'Bristol Trials Centre, Clincal Trials and Evaulation Unit, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Robert Mr', 'Initials': 'RM', 'LastName': 'Tulloh', 'Affiliation': 'National Institute for Health Research Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust and University of Bristol, Bristol, UK.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Caputo', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}]",BMJ open,['10.1136/bmjopen-2020-036974']
2765,33055122,Trial of remote ischaemic preconditioning in vascular cognitive impairment (TRIC-VCI): protocol.,"INTRODUCTION


Cerebral small vessel disease (cSVD) accounts for 20%-25% of strokes and is the most common cause of vascular cognitive impairment (VCI). In an animal VCI model, inducing brief periods of limb ischaemia-reperfusion reduces subsequent ischaemic brain injury with remote and local protective effects, with hindlimb remote ischaemic conditioning (RIC) improving cerebral blood flow, decreasing white-matter injury and improving cognition. Small human trials suggest RIC is safe and may prevent recurrent strokes. It remains unclear what doses of chronic daily RIC are tolerable and safe, whether effects persist after treatment cessation, and what parameters are optimal for treatment response.
METHODS AND ANALYSIS


This prospective, open-label, randomised controlled trial (RCT) with blinded end point assessment and run-in period, will recruit 24 participants, randomised to one of two RIC intensity groups: one arm treated once daily or one arm twice daily for 30 consecutive days. RIC will consistent of 4 cycles of blood pressure cuff inflation to 200 mm Hg for 5 min followed by 5 min deflation (total 35 min). Selection criteria include: age 60-85 years, evidence of cSVD on brain CT/MRI, Montreal Cognitive Assessment (MoCA) score 13-24 and preserved basic activities of living. Outcomes will be assessed at 30 days and 90 days (60 days after ceasing treatment). The primary outcome is adherence (completing ≥80% of sessions). Secondary safety/tolerability outcomes include the per cent of sessions completed and pain/discomfort scores from patient diaries. Efficacy outcomes include changes in cerebral blood flow (per arterial spin-label MRI), white-matter hyperintensity volume, diffusion tensor imaging, MoCA and Trail-Making tests.
ETHICS AND DISSEMINATION


Research Ethics Board approval has been obtained. The results will provide information on feasibility, dose, adherence, tolerability and outcome measures that will help design a phase IIb RCT of RIC, with the potential to prevent VCI. Results will be disseminated through peer-reviewed publications, organisations and meetings.
TRIAL REGISTRATION NUMBER


NCT04109963.",2020,"Efficacy outcomes include changes in cerebral blood flow (per arterial spin-label MRI), white-matter hyperintensity volume, diffusion tensor imaging, MoCA and Trail-Making tests.
","['24 participants', 'vascular cognitive impairment (TRIC-VCI', 'Selection criteria include: age 60-85 years, evidence of cSVD on brain CT/MRI, Montreal Cognitive Assessment (MoCA) score 13-24 and preserved basic activities of living']","['remote ischaemic preconditioning', 'limb ischaemia-reperfusion', 'hindlimb remote ischaemic conditioning (RIC']","['safety/tolerability outcomes include the per cent of sessions completed and pain/discomfort scores', 'cerebral blood flow, decreasing white-matter injury and improving cognition', 'adherence', 'cerebral blood flow (per arterial spin-label MRI), white-matter hyperintensity volume, diffusion tensor imaging, MoCA and Trail-Making tests']","[{'cui': 'C3805043', 'cui_str': 'Vascular cognitive impairment'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C2733158', 'cui_str': 'Small vessel cerebrovascular disease'}, {'cui': 'C0412585', 'cui_str': 'Computerized axial tomography of brain'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C2945695', 'cui_str': 'Limb ischemia'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0562018', 'cui_str': 'cent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0037914', 'cui_str': 'Spin Labels'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}]",24.0,0.282651,"Efficacy outcomes include changes in cerebral blood flow (per arterial spin-label MRI), white-matter hyperintensity volume, diffusion tensor imaging, MoCA and Trail-Making tests.
","[{'ForeName': 'Aravind', 'Initials': 'A', 'LastName': 'Ganesh', 'Affiliation': 'Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Barber', 'Affiliation': 'Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Black', 'Affiliation': 'Department of Medicine (Neurology), Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Corbett', 'Affiliation': 'Department of Cellular & Molecular Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Thalia S', 'Initials': 'TS', 'LastName': 'Field', 'Affiliation': 'Department of Medicine (Neurology), University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Frayne', 'Affiliation': 'Seaman Family MR Centre, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Hachinski', 'Affiliation': 'Department of Clinical Neurological Sciences, Western University, London, Ontario, Canada.'}, {'ForeName': 'Zahinoor', 'Initials': 'Z', 'LastName': 'Ismail', 'Affiliation': 'Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Mai', 'Affiliation': 'Department of Clinical Neurological Sciences, Western University, London, Ontario, Canada.'}, {'ForeName': 'Cheryl R', 'Initials': 'CR', 'LastName': 'McCreary', 'Affiliation': 'Department of Clinical Neurosciences and Radiology, University of Calgary Faculty of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Demetrios', 'Initials': 'D', 'LastName': 'Sahlas', 'Affiliation': 'Department of Medicine (Neurology), McMaster University Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mukul', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Department of Medicine (Neurology), McMaster University Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Swartz', 'Affiliation': 'Department of Medicine (Neurology), Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Smith', 'Affiliation': 'Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada eesmith@ucalgary.ca.'}]",BMJ open,['10.1136/bmjopen-2020-040466']
2766,33055139,"Six Months of Hybrid Closed-Loop Versus Manual Insulin Delivery With Fingerprick Blood Glucose Monitoring in Adults With Type 1 Diabetes: A Randomized, Controlled Trial.","OBJECTIVE


To investigate glycemic and psychosocial outcomes with hybrid closed-loop (HCL) versus user-determined insulin dosing with multiple daily injections (MDI) or insulin pump (i.e., standard therapy for most adults with type 1 diabetes).
RESEARCH DESIGN AND METHODS


Adults with type 1 diabetes using MDI or insulin pump without continuous glucose monitoring (CGM) were randomized to 26 weeks' HCL (Medtronic 670G) or continuation of current therapy. The primary outcome was masked CGM time in range (TIR; 70-180 mg/dL) during the final 3 weeks.
RESULTS


Participants were randomized to HCL ( n  = 61) or control ( n  = 59). Baseline mean (SD) age was 44.2 (11.7) years; HbA 1c  7.4% (0.9%) (57 [10] mmol/mol); 53% were women, and 51% used MDI. HCL TIR increased from (baseline) 55% (13%) to (26 weeks) 70% (10%) with the control group unchanged: (baseline) 55% (12%) and (26 weeks) 55% (13%) (difference 15% [95% CI 11, 19%];  P  < 0.0001). For HCL, HbA 1c  was lower (median [95% CI] difference -0.4% [-0.6, -0.2]; -4 mmol/mol [-7, -2];  P  < 0.0001) and diabetes-specific positive well-being higher (difference 1.2 [95% CI 0.4, 1.9];  P  < 0.0048) without a deterioration in diabetes distress, perceived sleep quality, or cognition. Seventeen (9 device-related) versus 13 serious adverse events occurred in the HCL and control groups, respectively.
CONCLUSIONS


In adults with type 1 diabetes, 26 weeks of HCL improved TIR, HbA 1c , and their sense of satisfaction from managing their diabetes than those continuing with user-determined insulin dosing and self-monitoring of blood glucose. For most people living with type 1 diabetes globally, this trial demonstrates that HCL is feasible, acceptable, and advantageous.",2020,"Seventeen (9 device-related) versus 13 serious adverse events occurred in the HCL and control groups, respectively.
","['Adults With Type 1 Diabetes', 'most adults with type 1 diabetes', 'Adults with type']","['MDI or insulin pump without continuous glucose monitoring (CGM', 'HCL', 'Hybrid Closed-Loop Versus Manual Insulin Delivery With Fingerprick Blood Glucose Monitoring', 'hybrid closed-loop (HCL) versus user-determined insulin dosing with multiple daily injections (MDI) or insulin pump', 'HCL (Medtronic 670G) or continuation of current therapy']","['diabetes distress, perceived sleep quality, or cognition', 'masked CGM time', 'diabetes-specific positive well-being higher', 'HCL TIR', 'serious adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.184635,"Seventeen (9 device-related) versus 13 serious adverse events occurred in the HCL and control groups, respectively.
","[{'ForeName': 'Sybil A', 'Initials': 'SA', 'LastName': 'McAuley', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Melissa H', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Paldus', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Vogrin', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Martin I', 'Initials': 'MI', 'LastName': 'de Bock', 'Affiliation': ""Department of Endocrinology and Diabetes, Perth Children's Hospital, Nedlands, Western Australia, Australia.""}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Abraham', 'Affiliation': ""Department of Endocrinology and Diabetes, Perth Children's Hospital, Nedlands, Western Australia, Australia.""}, {'ForeName': 'Leon A', 'Initials': 'LA', 'LastName': 'Bach', 'Affiliation': 'Department of Endocrinology and Diabetes, The Alfred, Melbourne, Victoria, Australia.'}, {'ForeName': 'Morton G', 'Initials': 'MG', 'LastName': 'Burt', 'Affiliation': 'Southern Adelaide Diabetes and Endocrine Services, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Neale D', 'Initials': 'ND', 'LastName': 'Cohen', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Colman', 'Affiliation': 'Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Davis', 'Affiliation': ""Department of Endocrinology and Diabetes, Perth Children's Hospital, Nedlands, Western Australia, Australia.""}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Hendrieckx', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'D Jane', 'Initials': 'DJ', 'LastName': 'Holmes-Walker', 'Affiliation': 'Department of Diabetes and Endocrinology, Westmead Hospital, Westmead, New South Wales, Australia.'}, {'ForeName': 'Joey', 'Initials': 'J', 'LastName': 'Kaye', 'Affiliation': 'Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Keech', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Kumareswaran', 'Affiliation': 'Department of Endocrinology and Diabetes, The Alfred, Melbourne, Victoria, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'MacIsaac', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Roland W', 'Initials': 'RW', 'LastName': 'McCallum', 'Affiliation': 'Department of Diabetes and Endocrinology, Royal Hobart Hospital, Hobart, Tasmania, Australia.'}, {'ForeName': 'Catriona M', 'Initials': 'CM', 'LastName': 'Sims', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Speight', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Stephen N', 'Initials': 'SN', 'LastName': 'Stranks', 'Affiliation': 'Southern Adelaide Diabetes and Endocrine Services, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Vijaya', 'Initials': 'V', 'LastName': 'Sundararajan', 'Affiliation': 'Department of Public Health, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Trawley', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Ward', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alicia J', 'Initials': 'AJ', 'LastName': 'Jenkins', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Jones', 'Affiliation': ""Department of Endocrinology and Diabetes, Perth Children's Hospital, Nedlands, Western Australia, Australia.""}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': ""O'Neal"", 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-1447']
2767,33055172,FDA Approval Summary: Tucatinib for the Treatment of Patients with Advanced or Metastatic HER2-Positive Breast Cancer.,"On April 17, 2020, the FDA approved tucatinib in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. This was the first new molecular entity evaluated under Project Orbis, an FDA Oncology Center of Excellence initiative which supports concurrent review of oncology drugs by multiple global health authorities. Approval was based on the HER2CLIMB trial, which randomized patients to receive tucatinib or placebo with trastuzumab and capecitabine. Tucatinib demonstrated efficacy compared to placebo in progression-free survival (PFS) (HR: 0.54, 95% CI: 0.42-0.71, p<0.00001) and overall survival (OS) (HR: 0.66, 95% CI: 0.50-0.87, p=0.00480). Patients with either treated and stable or active brain metastases made up 48% of the study population. PFS in patients with brain metastases confirmed benefit (HR: 0.48, 95% CI: 0.34-0.69, p<0.00001). The benefit in patients with brain metastases allowed for inclusion of this specific population in the indication. Important safety signals included diarrhea and hepatotoxicity which are listed under Warnings and Precautions. This article summarizes the FDA thought process and data supporting the favorable benefit-risk profile and approval of tucatinib.",2020,"Tucatinib demonstrated efficacy compared to placebo in progression-free survival (PFS) (HR: 0.54, 95% CI: 0.42-0.71, p<0.00001) and overall survival (OS) (HR: 0.66, 95% CI: 0.50-0.87, p=0.00480).","['patients with brain metastases', 'Patients with either treated and stable or active brain metastases made up 48% of the study population', 'Patients with Advanced or Metastatic HER2-Positive Breast Cancer', 'patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting']","['placebo', 'tucatinib or placebo with trastuzumab and capecitabine', 'trastuzumab and capecitabine']","['overall survival (OS', 'progression-free survival (PFS', 'diarrhea and hepatotoxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}]",,0.0798939,"Tucatinib demonstrated efficacy compared to placebo in progression-free survival (PFS) (HR: 0.54, 95% CI: 0.42-0.71, p<0.00001) and overall survival (OS) (HR: 0.66, 95% CI: 0.50-0.87, p=0.00480).","[{'ForeName': 'Mirat', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'Office of Oncologic Diseases, United States Food and Drug Administration mirat.shah@fda.hhs.gov.'}, {'ForeName': 'Suparna', 'Initials': 'S', 'LastName': 'Wedam', 'Affiliation': 'Office of Oncologic Diseases, United States Food and Drug Administration.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Office of Clinical Pharmacology, United States Food and Drug Administration.'}, {'ForeName': 'Mallorie H', 'Initials': 'MH', 'LastName': 'Fiero', 'Affiliation': 'United States Food and Drug Administration.'}, {'ForeName': 'Huiming', 'Initials': 'H', 'LastName': 'Xia', 'Affiliation': 'United States Food and Drug Administration.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Center for Drug Evaluation and Research, Food and Drug Administration.'}, {'ForeName': 'Jianghong', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Center for Drug Evaluation and Research, Food and Drug Administration.'}, {'ForeName': 'Xinyuan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Center for Drug Evaluation and Research, Food and Drug Administration.'}, {'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Office of Translational Sciences, United States Food and Drug Administration.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'Office of Hematology and Oncology Products, Food and Drug Administration.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'OND, US FDA CDER.'}, {'ForeName': 'Tiffany K', 'Initials': 'TK', 'LastName': 'Ricks', 'Affiliation': 'Div. of Hematology Oncology Toxicology, United States Food and Drug Administration.'}, {'ForeName': 'Xiao Hong', 'Initials': 'XH', 'LastName': 'Chen', 'Affiliation': 'Office of New Drugs Quality Assurance, United States Food and Drug Administration.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Goldberg', 'Affiliation': 'Oncology Center of Excellence, United States Food and Drug Administration.'}, {'ForeName': 'Yutao', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Oncology Center of Excellence, United States Food and Drug Administration.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Pierce', 'Affiliation': 'DOP1/OHOP/CDER, Food and Drug Administration.'}, {'ForeName': 'Shenghui', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'CDER, United States Food and Drug Administration.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Theoret', 'Affiliation': 'Center for Drug Evaluation and Research, Food and Drug Administration.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Office of Oncology Drug Products, United States Food and Drug Administration.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Amiri-Kordestani', 'Affiliation': 'Division of Oncology Products 1, Food and Drug Administration Center for Drug Evaluation and Research.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Beaver', 'Affiliation': 'Office of Hematology and Oncology, United States Food and Drug Administration.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-2701']
2768,33060999,Impact of occult renal disease on the outcomes of off-pump and on-pump coronary artery bypass grafting.,"Purpose


Occult renal disease (ORD) is a clinical condition in which glomerular filtration rate (GFR) is less than 60 ml/min/1.73 m 2 , while serum creatinine is ≤ 1.3 mg/dl. The aim of the study was to compare the incidence of postoperative stage I acute kidney injury (AKI) according to Acute Kidney Injury Network (AKIN) classification in patients with ORD undergoing either off-pump or on-pump coronary artery bypass grafting.
Methods


A single center prospective randomized study was conducted from March 2011 through January 2014. A total of 120 coronary artery disease (CAD) patients with ORD undergoing coronary artery bypass grafting (CABG) were randomized to either off-pump (group1,  n  = 62) or on-pump (group2,  n  = 58) CABG in 1:1 ratio by computer-generated random number table. The GFR and serum creatinine levels were measured preoperatively and postoperatively on day 1 and day 5. The primary outcome (postoperative AKI (stage I)) and secondary outcomes (AKI (stage III) requiring renal replacement therapy (RRT) death, myocardial infarction (MI), cerebrovascular accident, atrial fibrillation (AF), and re-exploration for bleeding) at 30 days were analyzed between the groups.
Results


There is no significant difference in baseline characteristics of patients between off-pump and on-pump group. The incidence of postoperative AKI (stage I) was similar between on-pump (20.69%) and off-pump (16.13%) groups ( p  = 0.51). There was no significant difference in mortality ( p  = 0.33), postoperative MI ( p  = 0.34), cerebrovascular accident ( p  = 1.00), re-exploration ( p  = 0.96), and AF ( p  = 0.50). The number of patients of stage III AKI requiring RRT was higher in the off-pump group (3 patients, 4.8%) and none in the on-pump group ( p  = 0.08).
Conclusions


This study demonstrated that on-pump CABG is associated with significantly lower GFR and significantly higher serum creatinine on postoperative day 1 which return to baseline by postoperative day 5. In patients with ORD undergoing CABG, the incidence of postoperative AKI and major adverse cardiac and cerebrovascular events were similar between off-pump or on-pump CABG patients.",2019,"There was no significant difference in mortality ( p  = 0.33), postoperative MI ( p  = 0.34), cerebrovascular accident ( p  = 1.00), re-exploration ( p  = 0.96), and AF ( p  = 0.50).","['patients with ORD undergoing either off-pump or on-pump coronary artery bypass grafting', 'patients with ORD undergoing', 'March 2011 through January 2014', '120 coronary artery disease (CAD) patients with ORD undergoing coronary artery bypass grafting (CABG']","['CABG', 'pump and on-pump coronary artery bypass grafting', 'pump (group1,  n \u2009=\u200962) or on-pump (group2,  n \u2009=\u200958']","['GFR and serum creatinine levels', 'primary outcome (postoperative AKI (stage I)) and secondary outcomes (AKI (stage III) requiring renal replacement therapy (RRT) death, myocardial infarction (MI), cerebrovascular accident, atrial fibrillation (AF), and re-exploration for bleeding', 'postoperative MI', 'incidence of postoperative AKI and major adverse cardiac and cerebrovascular events', 'number of patients of stage III AKI requiring RRT', 'incidence of postoperative AKI (stage I', 'cerebrovascular accident', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0182537', 'cui_str': 'Pump'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1293095', 'cui_str': 'Reexploration procedure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",120.0,0.212315,"There was no significant difference in mortality ( p  = 0.33), postoperative MI ( p  = 0.34), cerebrovascular accident ( p  = 1.00), re-exploration ( p  = 0.96), and AF ( p  = 0.50).","[{'ForeName': 'Lokeswara Rao', 'Initials': 'LR', 'LastName': 'Sajja', 'Affiliation': 'Division of Cardiothoracic Surgery, Star Hospitals, Road no. 10, Banjara Hills, Hyderabad, Telangana 500 034 India.'}, {'ForeName': 'Sudhanshu', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Division of Cardiothoracic Surgery, Star Hospitals, Road no. 10, Banjara Hills, Hyderabad, Telangana 500 034 India.'}, {'ForeName': 'Gopichand', 'Initials': 'G', 'LastName': 'Mannam', 'Affiliation': 'Division of Cardiothoracic Surgery, Star Hospitals, Road no. 10, Banjara Hills, Hyderabad, Telangana 500 034 India.'}, {'ForeName': 'Jyothsna', 'Initials': 'J', 'LastName': 'Guttikonda', 'Affiliation': 'Sajja Heart Foundation, Srinagar Colony, Hyderabad, 500 073 India.'}, {'ForeName': 'Venkata Ramachandra Raju', 'Initials': 'VRR', 'LastName': 'Pusapati', 'Affiliation': 'Sajja Heart Foundation, Srinagar Colony, Hyderabad, 500 073 India.'}, {'ForeName': 'Krishnamurthy Venkata Satya Siva', 'Initials': 'KVSS', 'LastName': 'Saikiran', 'Affiliation': 'Division of Cardiothoracic Surgery, Star Hospitals, Road no. 10, Banjara Hills, Hyderabad, Telangana 500 034 India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-018-0767-3']
2769,33061000,"""RFEF"" and mitral regurgitation jet direction: surrogate markers for likelihood of left ventricle reverse remodeling in patients with moderate chronic ischemic mitral regurgitation.","Purpose


Surgical management of moderate chronic ischemic mitral regurgitation (CIMR) is controversial. We propose a simplified classification of moderate CIMR based on regurgitant fraction (RF), ejection fraction (EF), and jet direction (central/eccentric) to predict left ventricle (LV) remodeling and identify patient subsets which need mitral valve (MV) repair along with coronary artery bypass grafting (CABG).
Methods


In this prospective controlled study ( n  = 210), patients with moderate CIMR were randomized. Group I ( n  = 106) underwent off-pump CABG alone while group II ( n  = 104) underwent CABG + MV repair. The product of regurgitation fraction and ejection fraction (""RFEF"") was taken as a surrogate for myocardial reserve. The cut-off defined was 0.12; patients with RFEF ≤ 0.12 were categorized as the ""bad"" and those with RFEF > 0.12 as the ""good"" subset. The patients were further subdivided on the basis of their mitral regurgitation (MR) jet direction (central/eccentric). The percentage improvement in left ventricular end-systolic volume index (LVESVI) and MR grade were recorded 6 monthly.
Results


Analysis of the continuous variable ""RFEF"" in conjunction with jet direction was performed. At 12 months, the patient in good subset with central direction of jet showed improvement in LVESVI % in both groups ( p  = 0.428), while the patients in bad subset with eccentric direction of jet showed significantly higher improvement in LVESVI %, group II as compared to group I ( p  = 0.004).
Conclusion


This study thus identifies ""RFEF"" as a surrogate for reverse remodeling capacity. In association with MR jet direction, predicts the subset of moderate CIMR patients most likely to have maximum LVESVI and MR grade reduction.",2019,"We propose a simplified classification of moderate CIMR based on regurgitant fraction (RF), ejection fraction (EF), and jet direction (central/eccentric) to predict left ventricle (LV) remodeling and identify patient subsets which need mitral valve (MV) repair along with coronary artery bypass grafting (CABG).
","['moderate chronic ischemic mitral regurgitation (CIMR', ' n \u2009=\u2009210), patients with moderate CIMR', 'patients with moderate chronic ischemic mitral regurgitation']","['CABG + MV repair', 'RFEF"" and mitral regurgitation jet direction', 'pump CABG alone', 'coronary artery bypass grafting (CABG']","['regurgitant fraction (RF), ejection fraction (EF), and jet direction (central/eccentric', 'product of regurgitation fraction and ejection fraction (""RFEF', 'left ventricular end-systolic volume index (LVESVI) and MR grade', 'LVESVI']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4087284', 'cui_str': 'Ischaemic mitral regurgitation'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0396849', 'cui_str': 'Mitral valvuloplasty'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0182537', 'cui_str': 'Pump'}]","[{'cui': 'C1302309', 'cui_str': 'Regurgitant fraction'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",,0.0190204,"We propose a simplified classification of moderate CIMR based on regurgitant fraction (RF), ejection fraction (EF), and jet direction (central/eccentric) to predict left ventricle (LV) remodeling and identify patient subsets which need mitral valve (MV) repair along with coronary artery bypass grafting (CABG).
","[{'ForeName': 'Sumbul', 'Initials': 'S', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, U. N. Mehta Institute of Cardiology and Research Center (Affiliated to BJ Medical College, Ahmedabad), Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat 380016 India.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, U. N. Mehta Institute of Cardiology and Research Center (Affiliated to BJ Medical College, Ahmedabad), Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat 380016 India.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Shah', 'Affiliation': 'Department of Research, U. N. Mehta Institute of Cardiology and Research Center (Affiliated to BJ Medical College, Ahmedabad), Ahmedabad, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Garg', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, U. N. Mehta Institute of Cardiology and Research Center (Affiliated to BJ Medical College, Ahmedabad), Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat 380016 India.'}, {'ForeName': 'Pranav', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, U. N. Mehta Institute of Cardiology and Research Center (Affiliated to BJ Medical College, Ahmedabad), Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat 380016 India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Wadhawa', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, U. N. Mehta Institute of Cardiology and Research Center (Affiliated to BJ Medical College, Ahmedabad), Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat 380016 India.'}, {'ForeName': 'Kartik', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, U. N. Mehta Institute of Cardiology and Research Center (Affiliated to BJ Medical College, Ahmedabad), Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat 380016 India.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Shukla', 'Affiliation': 'Department of Cardiology, U. N. Mehta Institute of Cardiology and Research Center (Affiliated to BJ Medical College, Ahmedabad), Ahmedabad, India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-018-0717-0']
2770,33061023,Five-year clinical outcomes of diabetic patients in the Randomized On/Off Bypass Follow-up (ROOBY-FS) trial-is the evidence enough to change the practice?,,2019,,['diabetic patients'],[],[],"[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],,0.0955796,,"[{'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Narayan', 'Affiliation': 'Department of Cardiac Surgery, NH Rabindranath Tagore International Institute of Cardiac Sciences (RTIICS), Kolkata, 700099 India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-018-00781-z']
2771,33061029,Effect of goal-directed therapy on post-operative neutrophil gelatinase-associated lipocalin profile in patients undergoing on-pump coronary artery surgery.,"Purpose


Neutrophil gelatinase-associated lipocalin (NGAL) is an early biomarker of acute kidney injury (AKI). Goal-directed therapy (GDT) in on-pump coronary artery bypass grafting (CABG) has been associated with lower post-operative NGAL levels in recent studies. The present study aimed at comparing plasma (P) and urinary (U)-NGAL levels following the use of GDT versus conventional haemodynamic therapy (CT) in patients undergoing on-pump CABG.
Methods


A prospective randomised controlled study conducted in a single university hospital. A total of 54 patients in the GDT group and 56 patients in CT group after exclusions.
Results


U-NGAL was significantly lower immediately post-surgery ( T   1 ) in GDT group (25.11 ± 1.5 versus 27.80 ± 1.7 μg/L;  p  < 0.001) and at 4 h ( T   2 ) (38.19 ± 23.6 versus 52.30 ± 28.3 μg/L;  p  = 0.006) and at 24 h post-operatively ( T   3 ) (34.85 ± 14 versus 39.7 ± 11.1 μg/L;  p  = 0.047). P-NGAL was comparable between groups at  T   1  but lower in the GDT group at  T   2  (92.81 ± 4.8 versus 94.77 ± 4.5 μg/L;  p  = 0.03) and  T   3  (67.44 ± 3.7 versus 75.96 ± 5.3 μg/L;  p  < 0.001). U-NGAL levels correlated well with the peak post-operative creatinine as compared to P-NGAL. On-pump patients manifest neutrophil activation, accounting for comparable levels of P-NGAL in the two groups at  T   1 . GDT-based haemodynamic management resulted in lower U-NGAL levels at  T   1 ,  T   2  and  T   3  and lower P-NGAL levels at  T   2  and  T   3 .
Conclusions


Haemodynamic optimisation with GDT prevents further renal insult initiated with the inflammatory activation with cardiopulmonary bypass (CPB), as evidenced by lower post-operative U-NGAL levels.",2019,"GDT-based haemodynamic management resulted in lower U-NGAL levels at  T   1 ,  T   2  and  T   3  and lower P-NGAL levels at  T   2  and  T   3 .
","['patients undergoing on-pump coronary artery surgery', '54 patients in the GDT group and 56 patients in CT group after exclusions', 'patients undergoing on-pump CABG']","['GDT', 'goal-directed therapy', 'Neutrophil gelatinase-associated lipocalin (NGAL', 'pump coronary artery bypass grafting (CABG', 'GDT versus conventional haemodynamic therapy (CT', 'Goal-directed therapy (GDT']","['plasma (P) and urinary (U)-NGAL levels', 'U-NGAL', 'U-NGAL levels', 'lower U-NGAL levels', 'P-NGAL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0190188', 'cui_str': 'Operative procedure on coronary artery'}, {'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.132515,"GDT-based haemodynamic management resulted in lower U-NGAL levels at  T   1 ,  T   2  and  T   3  and lower P-NGAL levels at  T   2  and  T   3 .
","[{'ForeName': 'Poonam Malhotra', 'Initials': 'PM', 'LastName': 'Kapoor', 'Affiliation': 'Department of Cardiac Anaesthesia, Cardiothoracic Centre, CNC, All India Institute of Medical Sciences, Room No. 8, 7th Floor, Cardiothoracic Centre, Cardiothoracic Centre, Ansari Nagar, New Delhi, 110029 India.'}, {'ForeName': 'Ameya', 'Initials': 'A', 'LastName': 'Karanjkar', 'Affiliation': 'Department of Cardiac Anaesthesia, Cardiothoracic Centre, CNC, All India Institute of Medical Sciences, Room No. 8, 7th Floor, Cardiothoracic Centre, Cardiothoracic Centre, Ansari Nagar, New Delhi, 110029 India.'}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Magoon', 'Affiliation': 'Department of Cardiac Anaesthesia, Cardiothoracic Centre, CNC, All India Institute of Medical Sciences, Room No. 8, 7th Floor, Cardiothoracic Centre, Cardiothoracic Centre, Ansari Nagar, New Delhi, 110029 India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Taneja', 'Affiliation': 'Department of Cardiac Anaesthesia, Cardiothoracic Centre, CNC, All India Institute of Medical Sciences, Room No. 8, 7th Floor, Cardiothoracic Centre, Cardiothoracic Centre, Ansari Nagar, New Delhi, 110029 India.'}, {'ForeName': 'Sambhunath', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Department of Cardiac Anaesthesia, Cardiothoracic Centre, CNC, All India Institute of Medical Sciences, Room No. 8, 7th Floor, Cardiothoracic Centre, Cardiothoracic Centre, Ansari Nagar, New Delhi, 110029 India.'}, {'ForeName': 'Vishwas', 'Initials': 'V', 'LastName': 'Malik', 'Affiliation': 'Department of Cardiac Anaesthesia, Cardiothoracic Centre, CNC, All India Institute of Medical Sciences, Room No. 8, 7th Floor, Cardiothoracic Centre, Cardiothoracic Centre, Ansari Nagar, New Delhi, 110029 India.'}, {'ForeName': 'Ujjwal Kumar', 'Initials': 'UK', 'LastName': 'Chowdhury', 'Affiliation': 'Cardiothoracic and Vascular Surgery, All India Institute of Medical Sciences, Cardiothoracic Centre, CNC, Ansari Nagar, New Delhi, 110029 India.'}, {'ForeName': 'Vajala', 'Initials': 'V', 'LastName': 'Ravi', 'Affiliation': 'Lady Shri Ram College, University of Delhi, New Delhi, 110024 India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-018-0758-4']
2772,33061101,Has Arterial Revascularization Trial [ART] burst the BITA bubble?,"The 10-year outcome of the Arterial Revascularization Trial (ART) has recently been published. The study is the largest randomized study comparing bilateral internal thoracic artery (BITA) with single internal thoracic artery (SITA) as a grafting strategy for coronary artery bypass. In this review, a critical appraisal of the study has been performed where the result of the trial has been discussed along with the risk of sternal wound infections, the presence of a learning curve, and the influence of volume on outcomes. The influence of BITA grafting on other aspects like influence on hospital stay and quality of life outcomes has also been discussed.",2020,The influence of BITA grafting on other aspects like influence on hospital stay and quality of life outcomes has also been discussed.,['coronary artery bypass'],['bilateral internal thoracic artery (BITA) with single internal thoracic artery (SITA'],['hospital stay and quality of life outcomes'],"[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0226276', 'cui_str': 'Structure of internal thoracic artery'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0237355,The influence of BITA grafting on other aspects like influence on hospital stay and quality of life outcomes has also been discussed.,"[{'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Narayan', 'Affiliation': 'Department of Cardiac Surgery, NH Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata, 700099 India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-019-00833-y']
2773,33061256,"Overnight Safety Evaluation of a Multi-Pressure Dial in Eyes with Glaucoma: Prospective, Open-Label, Randomized Study.","Purpose


To investigate the safety and tolerability of the multi-pressure dial (MPD) worn overnight for seven consecutive days.
Design


Prospective, open-label, randomized, single-site study.
Subjects


Twenty eyes of 10 subjects with open-angle glaucoma were fitted with an MPD and randomized to negative pressure application of -10 mmHg in one eye (study eye) worn overnight for 7 consecutive days.
Methods


Safety measures included best-corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline during and after negative pressure application, slit lamp and dilated fundus exam findings, and rate of adverse events. Subjective assessments were completed daily by the subjects during the 7-day study period and immediately following the study period.
Results


Prior to the 7-day testing period, application of 10 mmHg negative pressure reduced mean IOP from 18.2 ± 3.8 mmHg to 14.0 ± 2.1 mmHg (p<0.01), a 22% reduction. After 7 days of consecutive nightly wear, repeat IOP measurements with the application of negative pressure showed a decrease in mean IOP from 16.9 ± 4.3 mmHg to 13.5 ± 3.7 mmHg. The observed IOP reduction was in addition to the subjects' current treatment regimen. There were no statistically significant changes in IOP, BCVA from baseline following the 7-day period of nightly wear with the application of negative pressure. The patient-reported outcomes were favorable.
Conclusion


The MPD can safely and comfortably be worn overnight. The decrease in IOP of >20% in addition to current therapy is both clinically and statistically significant. The MPD shows promise as a potential new treatment option for nocturnal IOP control.",2020,"There were no statistically significant changes in IOP, BCVA from baseline following the 7-day period of nightly wear with the application of negative pressure.","['Subjects\n\n\nTwenty eyes of 10 subjects with open-angle glaucoma', 'Eyes with Glaucoma', 'seven consecutive days']","['multi-pressure dial (MPD', 'Multi-Pressure Dial', 'MPD and randomized to negative pressure application of -10 mmHg in one eye (study eye) worn overnight for 7 consecutive days']","['safety and tolerability', 'IOP, BCVA', 'corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline during and after negative pressure application, slit lamp and dilated fundus exam findings, and rate of adverse events', 'IOP reduction', 'IOP']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0183355', 'cui_str': 'Slit lamp biomicroscope'}, {'cui': 'C0700124', 'cui_str': 'Ectatic'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",10.0,0.0254859,"There were no statistically significant changes in IOP, BCVA from baseline following the 7-day period of nightly wear with the application of negative pressure.","[{'ForeName': 'Tanner J', 'Initials': 'TJ', 'LastName': 'Ferguson', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Nathan M', 'Initials': 'NM', 'LastName': 'Radcliffe', 'Affiliation': 'New York Eye and Ear Infirmary of Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Van Tassel', 'Affiliation': 'Department of Ophthalmology, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Baartman', 'Affiliation': 'Vance Thompson Vision, Sioux Falls, SD, USA.'}, {'ForeName': 'Vance M', 'Initials': 'VM', 'LastName': 'Thompson', 'Affiliation': 'Vance Thompson Vision, Sioux Falls, SD, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Lindstrom', 'Affiliation': 'Vance Thompson Vision, Sioux Falls, SD, USA.'}, {'ForeName': 'Mitch J', 'Initials': 'MJ', 'LastName': 'Ibach', 'Affiliation': 'Vance Thompson Vision, Sioux Falls, SD, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Berdahl', 'Affiliation': 'Vance Thompson Vision, Sioux Falls, SD, USA.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S256891']
2774,33061274,Comparison of Subjective Preoperative Experiences of Patients Before First- or Second-Eye Cataract Surgeries.,"Purpose


To compare the subjective preoperative experiences of patients undergoing their first- or second-cataract surgeries.
Patients and Methods


Consecutive patients undergoing phacoemulsification were asked to complete postoperative questionnaires evaluating their subjective preoperative experiences, including their emotional state, decision-making process, and opinions on the admission and examination processes, medical interviews, and quality of service. The obtained data were compared between patients undergoing their first (group I)- or second (group II)-cataract surgeries.
Results


Two hundred patients (group I, 124; group II, 76) were included in the evaluation. Presurgical anxiety was more prevalent in group I than in group II (55.7% vs 34.2%,  P  = 0.005). Fear was the major trigger for reconsidering the decision to undergo surgery, with 29% and 13.2% of patients in groups I and II, respectively, considering abandoning the operation ( P  = 0.016). The preoperative medical examination was reported to be sufficiently accurate by 66.1% and 80.3% of patients in groups I and II, respectively ( P  = 0.047), while 28.2% and 21% of patients in groups I and II, respectively, did not understand the information presented about possible complications of surgery ( P  = 0.039). Administration of eyedrops before surgery was uncomfortable for 71.4% and 68.4% of patients in groups I and II, respectively ( P  = 0.553), while 22.6% and 9.2% of patients in groups I and II, respectively, found repeated administration of drops to be highly uncomfortable (P = 0.026).
Conclusion


Patients experienced greater anxiety before their first-cataract surgery than before their second-cataract surgery. Moreover, many patients from both groups did not understand the medical information provided by doctors regarding the surgery and its possible complications. The most unpleasant stage of preparation for cataract surgery was repeated administration of eyedrops.
Trial Registration


The study was registered on clinicaltrial.gov under the number NCT04327856.",2020,"Administration of eyedrops before surgery was uncomfortable for 71.4% and 68.4% of patients in groups I and II, respectively ( P  = 0.553), while 22.6% and 9.2% of patients in groups I and II, respectively, found repeated administration of drops to be highly uncomfortable (P = 0.026).
","['patients undergoing their first- or second-cataract surgeries', 'Patients Before First- or Second-Eye Cataract Surgeries', 'Two hundred patients (group I, 124; group II, 76) were included in the evaluation']",['eyedrops'],"['subjective preoperative experiences', 'preoperative medical examination', 'emotional state, decision-making process, and opinions on the admission and examination processes, medical interviews, and quality of service', 'Presurgical anxiety', 'anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0015399', 'cui_str': 'Eye drops'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",200.0,0.0214365,"Administration of eyedrops before surgery was uncomfortable for 71.4% and 68.4% of patients in groups I and II, respectively ( P  = 0.553), while 22.6% and 9.2% of patients in groups I and II, respectively, found repeated administration of drops to be highly uncomfortable (P = 0.026).
","[{'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Ługowska', 'Affiliation': 'Department of Ophthalmology, Medical University of Bialystok, Bialystok 15-276, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Konopinska', 'Affiliation': 'Department of Ophthalmology, Medical University of Bialystok, Bialystok 15-276, Poland.'}, {'ForeName': 'Zofia', 'Initials': 'Z', 'LastName': 'Mariak', 'Affiliation': 'Department of Ophthalmology, Medical University of Bialystok, Bialystok 15-276, Poland.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Obuchowska', 'Affiliation': 'Department of Ophthalmology, Medical University of Bialystok, Bialystok 15-276, Poland.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S270196']
2775,33061275,The Efficacy Between Conventional Lid Hygiene and Additional Thermal Pulsatile System in Meibomian Gland Dysfunction Patients Treated with Long-Term Anti-Glaucoma Medications in a Randomized Controlled Trial.,"Purpose


To evaluate the efficacy of additional thermal pulsatile system compared to standard lid hygiene alone in meibomian gland dysfunction (MGD) patients who are using long-term anti-glaucoma medications.
Patients and Methods


Well-controlled glaucoma patients who used anti-glaucoma medications for at least 1 year and had MGD were enrolled and randomized between a study group who received thermal pulsatile system (Lipiflow ® ) treatment and standard lid hygiene, and a control group who received standard lid hygiene alone. The primary outcome was meibomian gland expression score, and the secondary outcomes were the Ocular Surface Disease Index (OSDI) score, Schirmer test score, tear break-up time (TBUT), corneal staining score, lipid layer thickness (LLT), and meibography score. All the outcomes were re-evaluated at 1 week, then at 1, 3, and 6 months after treatment.
Results


Of 60 participants who underwent randomization, 48 completed the study. At the 6-month mark, this study could not demonstrate any significant difference between groups in both primary and secondary outcomes. However, there was significant improvement from baseline in both groups of the following outcomes: meibomian gland expression score, OSDI score, LLT, and meibography score. No serious adverse event was found in this study.
Conclusion


An additional single thermal pulsatile system treatment with standard lid hygiene significantly improved meibomian gland assessment score and subjective symptoms at 6 months. Any difference between additional thermal pulsatile system treatment and lid hygiene alone was not found in this study. The results may suggest more chronic MGD and more damaged meibomian gland induced by long-term anti-glaucoma medications.",2020,"At the 6-month mark, this study could not demonstrate any significant difference between groups in both primary and secondary outcomes.","['Patients and Methods\n\n\nWell-controlled glaucoma patients who used anti-glaucoma medications for at least 1 year and had MGD', 'meibomian gland dysfunction (MGD) patients who are using long-term anti-glaucoma medications', 'Meibomian Gland Dysfunction Patients Treated with Long-Term Anti-Glaucoma Medications', '60 participants who underwent randomization, 48 completed the study']","['standard lid hygiene alone', 'Conventional Lid Hygiene and Additional Thermal Pulsatile System', 'thermal pulsatile system (Lipiflow ® ) treatment and standard lid hygiene, and a control group who received standard lid hygiene alone', 'additional thermal pulsatile system']","['meibomian gland assessment score and subjective symptoms', 'meibomian gland expression score', 'Ocular Surface Disease Index (OSDI) score, Schirmer test score, tear break-up time (TBUT), corneal staining score, lipid layer thickness (LLT), and meibography score', 'meibomian gland expression score, OSDI score, LLT, and meibography score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439606', 'cui_str': 'Pulsatile'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",60.0,0.0803014,"At the 6-month mark, this study could not demonstrate any significant difference between groups in both primary and secondary outcomes.","[{'ForeName': 'Ngamjit', 'Initials': 'N', 'LastName': 'Kasetsuwan', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok 10330, Thailand.'}, {'ForeName': 'Disorn', 'Initials': 'D', 'LastName': 'Suwajanakorn', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok 10330, Thailand.'}, {'ForeName': 'Chitchanok', 'Initials': 'C', 'LastName': 'Tantipat', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok 10330, Thailand.'}, {'ForeName': 'Usanee', 'Initials': 'U', 'LastName': 'Reinprayoon', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok 10330, Thailand.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S259692']
2776,33061276,Evaluation of Visual and Subjective Outcomes with Mix-and-Match of Three One-Piece Tecnis Multifocal IOLs of Varying Add Powers.,"Purpose


To evaluate visual and subjective outcomes after bilateral mix-and-match implantation of one-piece diffractive multifocal IOLs in different near add powers (+2.75 D, +3.25 D, +4.0 D).
Setting


Four US clinics.
Design


Prospective, multi-center, parallel comparison clinical study design.
Patients and Methods


Two treatment groups received implantation with either the +3.25 D (ZLB00) or the +4.00 D (ZMB00) Tecnis ®  Multifocal 1-piece IOL in their non-dominant eye, and the +2.75 D (ZKB00) Tecnis Multifocal 1-piece IOL in their dominant eye (Abbott Medical Optics, Inc., Santa Ana, CA). Each study patient underwent the same routine cataract extraction procedures for each eye, with the second eye scheduled to undergo cataract extraction within 7 to 30 days after the 1st eye surgery. Visual and subjective outcomes were evaluated at 90 days after 2nd eye surgery for the two groups: +3.25D/+2.75D (n=41) and +4.00D/+2.75D (n=36).
Results


Mean binocular uncorrected distance visual acuities at 90 days postop were 0.02 ± 0.082 (+3.25D/+2.75D) vs 0.07 ± 0.128 (+4.00D/+2.75D) (p=0.025). Mean binocular uncorrected intermediate visual acuities at 90 days postop were 0.14 ± 0.185 (+3.25D/+2.75D) vs 0.26 ± 0.261 (+4.00D/+2.75D) (p=0.024). Mean binocular uncorrected near visual acuities at 90 days postop were 0.06 ± 0.098 (+3.25D/+2.75D) vs 0.19 ± 0.286 (+4.00D/+2.75D) (p=0.018). Over 88% of patients reported ""none"" for visual symptoms of glare, halos, starburst, or other. Freedom from glasses or contacts was reported by groups +3.25D/+2.75D and +4.00D/+2.75D as follows: distance (95.1% vs 97.1%), intermediate (92.7% vs 94.1%), and near activities (82.9% vs 64.7%).
Conclusion


At 90 days postoperatively, both groups demonstrated good visual and subjective outcomes; however, differences in near and intermediate outcomes favored the +3.25/+2.75 IOL combination.
Clinicaltrialsgov Registration


NCT02863159 (08/11/2016).",2020,"At 90 days postoperatively, both groups demonstrated good visual and subjective outcomes; however, differences in near and intermediate outcomes favored the +3.25/+2.75 IOL combination.
","['Each study patient underwent the same routine cataract extraction procedures for each eye, with the second eye scheduled to undergo cataract extraction within 7 to 30 days after the 1st eye surgery']","['implantation with either the +3.25 D (ZLB00) or the +4.00 D (ZMB00) Tecnis ®  Multifocal 1-piece IOL in their non-dominant eye, and the +2.75 D (ZKB00']","['Mean binocular uncorrected near visual acuities', 'Mean binocular uncorrected distance visual acuities', 'Visual and subjective outcomes', 'Mean binocular uncorrected intermediate visual acuities', 'good visual and subjective outcomes']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0038901', 'cui_str': 'Ophthalmologic Surgical Procedure'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4517639', 'cui_str': '2.75'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",,0.0461146,"At 90 days postoperatively, both groups demonstrated good visual and subjective outcomes; however, differences in near and intermediate outcomes favored the +3.25/+2.75 IOL combination.
","[{'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Dell', 'Affiliation': 'Dell Laser Consultants, Austin, TX, USA.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S266120']
2777,33056965,[The influence of long-term retinal protective therapy on glaucoma progression according to structural and functional tests].,"PURPOSE


To evaluate the influence of prolonged neuroprotective therapy on disease progression in patients with primary open-angle glaucoma (POAG) with compensated intraocular pressure (IOP).
MATERIAL AND METHODS


The study included 147 patients with stages I-II POAG (249 eyes) who were randomized into the main (69 patients, 119 eyes) and control groups (78 patients, 130 eyes). Patients of the main group underwent retinalamin treatment course every 6 months. Patients were examined before enrolling and then every 3 months during the 24-months follow-up including optical coherence tomography (OCT; RNFL - retinal nerve fiber layer, NRR - neuroretinal rim, GCL - ganglion cell layer) and static perimetry (MD - mean deviation, PSD - pattern standard deviation).
RESULTS


Visual acuity and refraction did not change in either group ( p >0.05). IOP increased in the control group ( p =0.033). There was no difference between the groups by the 24th month ( p =0.87). No MD changes were noted in the main ( p =0.45) and control groups ( p =0.27). PSD changed in the main (4.84±3.21 and 6.01±2.584 dB in the beginning and the end, respectively,  p =0.0004) and the control groups (3.46±2.23 and 5.86±2.26 dB, respectively;  p <0.0001). The groups differed in MD and PSD initially ( p =0.15;  p =0.02) and became equal by the end ( p =0.59;  p =0.53). RNFL did not change significantly in the main group ( p =0.078) and decreased from 83.5±22.47 to 76.7±20.7 µm in the control group ( p =0.001); no differences between the groups were noted in the beginning ( p =0.276) or in the end of the study ( p =0.524). NRR increased in the main group from 222±88.94 to 231±99.3 ( p =0.012), and decreased in the control group from 248±87.09 to 234±96.2 ( p =0.0006); no differences were found between groups in the beginning or in the end of the study ( p =0.109;  p =0.909). GCL thickness did not change either in the main, or in the control group ( p =0.211;  p =0.16), with no difference between the group noted in the beginning or the end of the study ( p =0.44;  p =0.51).
CONCLUSION


Regular treatment with retinalamin arrests the development of glaucomatous optic neuropathy. Longer-term research is required to study its influence on the visual function and the quality of life.",2020,"NRR increased in the main group from 222±88.94 to 231±99.3 ( p =0.012), and decreased in the control group from 248±87.09 to 234±96.2 ( p =0.0006); no differences were found between groups in the beginning or in the end of the study ( p =0.109;  p =0.909).","['147 patients with stages I-II POAG (249 eyes) who were randomized into the main (69 patients, 119 eyes) and control groups (78 patients, 130 eyes', 'patients with primary open-angle glaucoma (POAG) with compensated intraocular pressure (IOP']","['prolonged neuroprotective therapy', 'long-term retinal protective therapy', 'retinalamin']","['Visual acuity and refraction', 'disease progression', 'GCL thickness', 'glaucoma progression', 'glaucomatous optic neuropathy', 'PSD', 'RNFL', 'MD changes', 'IOP', 'NRR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1610354', 'cui_str': 'retinalamin'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0023521', 'cui_str': 'Galactosylceramide beta-galactosidase deficiency'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0029132', 'cui_str': 'Disorder of optic nerve'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",147.0,0.0311746,"NRR increased in the main group from 222±88.94 to 231±99.3 ( p =0.012), and decreased in the control group from 248±87.09 to 234±96.2 ( p =0.0006); no differences were found between groups in the beginning or in the end of the study ( p =0.109;  p =0.909).","[{'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Strakhov', 'Affiliation': 'Yaroslavl State Medical University, Yaroslavl, Russia.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Egorov', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'V P', 'Initials': 'VP', 'LastName': 'Erichev', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Yartsev', 'Affiliation': 'Yaroslavl State Medical University, Yaroslavl, Russia.'}, {'ForeName': 'S Yu', 'Initials': 'SY', 'LastName': 'Petrov', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Dorofeev', 'Affiliation': 'Regional clinical hospital No 3, Chelyabinsk, Russia.'}]",Vestnik oftalmologii,['10.17116/oftalma202013605158']
2778,33057017,Author Correction: Inhaled nitric oxide therapy in acute bronchiolitis: A multicenter randomized clinical trial.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,['acute bronchiolitis'],['nitric oxide therapy'],[],"[{'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.08724,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Aviv', 'Initials': 'A', 'LastName': 'Goldbart', 'Affiliation': 'Saban Pediatric Medical Center, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University, Beer Sheva, Israel. avivgold@bgu.ac.il.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Golan-Tripto', 'Affiliation': 'Saban Pediatric Medical Center, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University, Beer Sheva, Israel.'}, {'ForeName': 'Giora', 'Initials': 'G', 'LastName': 'Pillar', 'Affiliation': 'Carmel Medical Center, Haifa, Israel.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Livnat-Levanon', 'Affiliation': 'Carmel Medical Center, Haifa, Israel.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Efrati', 'Affiliation': 'Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Spiegel', 'Affiliation': 'Haemek Medical Center, Afula, Israel.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Lubetzky', 'Affiliation': ""Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Moran', 'Initials': 'M', 'LastName': 'Lavie', 'Affiliation': ""Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Carmon', 'Affiliation': 'Saban Pediatric Medical Center, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University, Beer Sheva, Israel.'}, {'ForeName': 'Abdi', 'Initials': 'A', 'LastName': 'Ghaffari', 'Affiliation': ""Department of Pathology and Molecular Medicine, Queen's University, Kingston, ON, Canada, K7L 3N6.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Nahum', 'Affiliation': 'Saban Pediatric Medical Center, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University, Beer Sheva, Israel.'}]",Scientific reports,['10.1038/s41598-020-70779-4']
2779,33055099,Covid-19: Eli Lilly pauses antibody trial for safety reasons.,,2020,,[],[],[],[],[],[],,0.0262004,,"[{'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Dyer', 'Affiliation': 'Montreal, Canada.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m3985']
2780,33055112,Effect of mHealth tool on knowledge regarding reproductive health of school going adolescent girls: a before-after quasi-experimental study.,"OBJECTIVE


This study was executed to (1) assess the effect of mHealth (mobile health) tool on knowledge regarding reproductive health (RH) of adolescent girls and (2) determine the utilisation of mHealth tool among school girls.
DESIGN


Before-after type of quasi-experimental study.
SETTING


Dhaka North City Corporation in Bangladesh.
PARTICIPANTS


400 adolescent girls aged 14-19 years were selected based on defined criteria.
INTERVENTIONS


Short message service (SMS) intervention on RH was delivered through a mobile phone.
PRIMARY AND SECONDARY OUTCOME MEASURES


8 schools out of 61 were randomly selected in the study area. A total of 400 girls were selected randomly on permission from those schools and parents. SMS interventions were delivered for 8 weeks. The data were collected using a self-administered questionnaire before and after SMS intervention to evaluate the effect. The number of responses to weekly SMS determined mHealth usage or practice.
RESULTS


Postintervention knowledge score (mean 70.8%±9.7%) on RH was significantly higher (paired t=69.721, p<0.001) than preintervention knowledge score (mean 44.71%±9.13%) with a large effect size (cohen's d=3.6). The knowledge score on RH was (p<0.001) correlated (+0.636) with SMS response. Multiple linear regression indicated that increase response to one SMS intervention there was an increase of knowledge score by 2.661% (linear slope 2.66, at 95% CI, p<0.001) after controlling the confounder. The mean knowledge score in all five knowledge segments of RH increased significantly (p<0.001) after SMS intervention.
CONCLUSION


The result indicated that the SMS tool of the mHealth approach is an easy and effective way to improve RH knowledge for adolescent girls. SMS intervention was well accepted by the girls. Thereby this mHealth tool can be chosen to provide health information for a mass approach.",2020,"The mean knowledge score in all five knowledge segments of RH increased significantly (p<0.001) after SMS intervention.
","['Dhaka North City Corporation in Bangladesh', 'school going adolescent girls', 'school girls', '400 girls were selected randomly on permission from those schools and parents', '400 adolescent girls aged 14-19 years were selected based on defined criteria', '8 schools out of 61 were randomly selected in the study area', 'adolescent girls']","['mHealth (mobile health', 'Short message service (SMS) intervention', 'SMS intervention', 'mHealth tool']","['preintervention knowledge score', 'knowledge score on RH', 'knowledge score', 'RH', 'mean knowledge score', 'RH knowledge']","[{'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0521104', 'cui_str': 'With permission of'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",400.0,0.0282648,"The mean knowledge score in all five knowledge segments of RH increased significantly (p<0.001) after SMS intervention.
","[{'ForeName': 'Tanima', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'Community Medicine, Uttara Adhunik Medical College, Dhaka, Bangladesh tanirif@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2019-036656']
2781,33055176,Incentive programmes for smoking cessation: cluster randomized trial in workplaces in Thailand.,"OBJECTIVE


To compare several monetary incentive programmes for promoting smoking abstinence among employees who smoke at workplaces in a middle income country.
DESIGN


Parallel group, open label, assessor blinded, cluster randomized controlled trial.
SETTING


Large industrial workplaces in metropolitan Bangkok, Thailand.
PARTICIPANTS


Employees who smoked cigarettes and planned to quit within six months recruited from 101 worksite clusters (84 different companies).
INTERVENTIONS


Worksites were digitally cluster randomized by an independent investigator to usual care or usual care plus one of eight types of incentive programmes. Usual care consisted of one time group counseling and cessation support through a 28 day text messaging programme. The incentive programmes depended on abstinence at three months and varied on three intervention components: refundable deposits, assignment to a teammate, and bonus size ($20 (£15; €17) or $40).
MAIN OUTCOME MEASURES


The primary outcome was biochemically verified seven day point prevalence smoking abstinence at 12 months. Secondary outcomes were programme acceptance at enrollment and smoking abstinence at three months (end of intervention) and at six months. All randomized participants who had complete baseline information were included in intention-to-treat analyses; participants with missing outcomes were coded as continuing smokers.
RESULTS


Between April 2015 and August 2016, the trial enrolled 4190 participants. Eighteen were omitted because of missing baseline covariates and death before the primary endpoint, therefore 4172 participants were included in the intention-to-treat analyses. Programme acceptance was relatively high across all groups: 58.7% (2451/4172) overall and 61.3% (271/442) in the usual care group. Abstinence rates at 12 months did not differ among deposit programmes (336/2253, 14.9%) and non-deposit programmes (280/1919, 14.6%; adjusted difference 0.8 points, 95% confidence interval -2.7 to 4.3, P=0.65), but were somewhat lower for team based programmes (176/1348, 13.1%) than individual based programmes (440/2824, 15.6%; -3.2 points, -6.6 to -0.2, P=0.07), and higher for $40 bonus programmes (322/1954, 16.5%) than programmes with no bonus (148/1198, 12.4%; 5.9 points, 2.1 to 9.7, P=0.002). The $40 individual bonus was the most efficacious randomization group at all endpoints. Intervention components did not strongly interact with each other.
CONCLUSIONS


Acceptance of monetary incentive programmes for promoting smoking abstinence was high across all groups. The $40 individual bonus programmes increased long term smoking abstinence compared with usual care, although several other incentive designs did not, such as team based programmes and deposit programmes. Incentive design in workplace wellness programmes might influence their effectiveness at reducing smoking rates in low resource settings.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT02421224).",2020,Programme acceptance was relatively high across all groups: 58.7% (2451/4172) overall and 61.3% (271/442) in the usual care group.,"['employees who smoke at workplaces in a middle income country', 'Large industrial workplaces in metropolitan Bangkok, Thailand', 'Employees who smoked cigarettes and planned to quit within six months recruited from 101 worksite clusters (84 different companies', 'All randomized participants who had complete baseline information were included in intention-to-treat analyses; participants with missing outcomes were coded as continuing smokers', 'Between April 2015 and August 2016', '4190 participants', '4172 participants were included in the intention-to-treat analyses']",['Worksites were digitally cluster randomized by an independent investigator to usual care or usual care plus one of eight types of incentive programmes'],"['Programme acceptance', 'Abstinence rates', 'biochemically verified seven day point prevalence smoking abstinence', 'smoking abstinence', 'long term smoking abstinence', 'programme acceptance at enrollment and smoking abstinence']","[{'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]",4190.0,0.230203,Programme acceptance was relatively high across all groups: 58.7% (2451/4172) overall and 61.3% (271/442) in the usual care group.,"[{'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'White', 'Affiliation': 'Philip R Lee Institute for Health Policy Studies, University of California, San Francisco, 3333 California Street, Box 0936, San Francisco, CA 94118, USA justin.white@ucsf.edu.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lowenstein', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA, USA.'}, {'ForeName': 'Nucharee', 'Initials': 'N', 'LastName': 'Srivirojana', 'Affiliation': 'Institute for Population and Social Research, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Aree', 'Initials': 'A', 'LastName': 'Jampaklay', 'Affiliation': 'Institute for Population and Social Research, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Dow', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA, USA.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m3797']
2782,33055188,The Mineralocorticoid Receptor Antagonist Eplerenone Suppress Interstitial Fibrosis in Subcutaneous Adipose Tissue in Type 2 Diabetes Patients.,"Activation of the mineralocorticoid receptor (MR) may promote dysfunctional adipose tissue in patients with type 2 diabetes, where increased pericellular fibrosis has emerged as a major contributor. The knowledge of the association between the MR, fibrosis and the effects of an MR antagonist (MRA) in human adipocytes remains very limited. The present sub-study including 30 participants was prespecified as part of the Mineralocorticoid Receptor Antagonist in type 2 Diabetes (MIRAD) trial, randomizing patients to either high dose eplerenone or placebo for 26 weeks. In adipose tissue biopsies, changes in fibrosis were evaluated by immunohistological examinations and by the expression of mRNA and protein markers of fibrosis. Treatment with an MRA reduced pericellular fibrosis, synthesis of the major subunits of collagen type I and VI, and the profibrotic factor α-smooth muscle actin, as compared to placebo in subcutaneous adipose tissue. Furthermore, we found decreased expression of the MR and downstream molecules neutrophil gelatinase-associated lipocalin, galectin-3, and lipocalin-like prostaglandin D2 synthase with an MRA. In conclusions, we present original data demonstrating reduced fibrosis in adipose tissue with inhibition of the MR, which could be a potential therapeutic approach to prevent the extracellular matrix remodeling of adipose tissue in type 2 diabetes.",2020,"Furthermore, we found decreased expression of the MR and downstream molecules neutrophil gelatinase-associated lipocalin, galectin-3, and lipocalin-like prostaglandin D2 synthase with an MRA.","['30 participants was prespecified as part of the Mineralocorticoid Receptor Antagonist in type 2 Diabetes (MIRAD) trial, randomizing patients to either high dose', 'Type 2 Diabetes Patients', 'patients with type 2 diabetes']","['MRA', 'Mineralocorticoid Receptor Antagonist Eplerenone', 'placebo', 'MR antagonist (MRA', 'eplerenone or placebo', 'mineralocorticoid receptor (MR']","['expression of the MR and downstream molecules neutrophil gelatinase-associated lipocalin, galectin-3, and lipocalin-like prostaglandin D2 synthase with an MRA']","[{'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0066563', 'cui_str': 'Mineralocorticoid Receptor'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0066563', 'cui_str': 'Mineralocorticoid Receptor'}, {'cui': 'C0522506', 'cui_str': 'Downstream'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0245382', 'cui_str': 'Galectin-3'}, {'cui': 'C0072296', 'cui_str': 'Prostaglandin-H>2< D-isomerase'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]",30.0,0.0233468,"Furthermore, we found decreased expression of the MR and downstream molecules neutrophil gelatinase-associated lipocalin, galectin-3, and lipocalin-like prostaglandin D2 synthase with an MRA.","[{'ForeName': 'Marie Louise', 'Initials': 'ML', 'LastName': 'Johansen', 'Affiliation': 'Centre of Endocrinology and Metabolism, Department of Internal Medicine, Copenhagen University Hospital, Herlev/Gentofte Hospital.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ibarrola', 'Affiliation': 'Cardiovascular Translational Research, Navarrabiomed, Complejo Hospitalario de Navarra (CHN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Amaya', 'Initials': 'A', 'LastName': 'Fernández-Celis', 'Affiliation': 'Cardiovascular Translational Research, Navarrabiomed, Complejo Hospitalario de Navarra (CHN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen.'}, {'ForeName': 'Mette Pauli', 'Initials': 'MP', 'LastName': 'Sonne', 'Affiliation': 'Centre of Endocrinology and Metabolism, Department of Internal Medicine, Copenhagen University Hospital, Herlev/Gentofte Hospital.'}, {'ForeName': 'Maria Refsgaard', 'Initials': 'MR', 'LastName': 'Holm', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Copenhagen University Hospital, Denmark.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Copenhagen University Hospital, Denmark.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Dela', 'Affiliation': 'Center for Healthy Aging, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Jaisser', 'Affiliation': 'INSERM UMRS 1138, Centre de Recherche des Cordeliers, Sorbonne University, Paris, France.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Centre of Endocrinology and Metabolism, Department of Internal Medicine, Copenhagen University Hospital, Herlev/Gentofte Hospital.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': 'Université de Lorraine, Inserm CIC Plurithémathique 1433, UMRS 1116 Inserm, CHRU Vandoeuvre-les-Nancy, and FCRIN INI-CRCT, Nancy, France.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Lopez-Andres', 'Affiliation': 'Cardiovascular Translational Research, Navarrabiomed, Complejo Hospitalario de Navarra (CHN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kistorp', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, cnkistorp@dadlnet.dk.'}]",Diabetes,['10.2337/db20-0394']
2783,33055231,Remdesivir against COVID-19 and Other Viral Diseases.,"SUMMARYPatients and physicians worldwide are facing tremendous health care hazards that are caused by the ongoing severe acute respiratory distress syndrome coronavirus 2 (SARS-CoV-2) pandemic. Remdesivir (GS-5734) is the first approved treatment for severe coronavirus disease 2019 (COVID-19). It is a novel nucleoside analog with a broad antiviral activity spectrum among RNA viruses, including ebolavirus (EBOV) and the respiratory pathogens Middle East respiratory syndrome coronavirus (MERS-CoV), SARS-CoV, and SARS-CoV-2. First described in 2016, the drug was derived from an antiviral library of small molecules intended to target emerging pathogenic RNA viruses.  In vivo , remdesivir showed therapeutic and prophylactic effects in animal models of EBOV, MERS-CoV, SARS-CoV, and SARS-CoV-2 infection. However, the substance failed in a clinical trial on ebolavirus disease (EVD), where it was inferior to investigational monoclonal antibodies in an interim analysis. As there was no placebo control in this study, no conclusions on its efficacy in EVD can be made. In contrast, data from a placebo-controlled trial show beneficial effects for patients with COVID-19. Remdesivir reduces the time to recovery of hospitalized patients who require supplemental oxygen and may have a positive impact on mortality outcomes while having a favorable safety profile. Although this is an important milestone in the fight against COVID-19, approval of this drug will not be sufficient to solve the public health issues caused by the ongoing pandemic. Further scientific efforts are needed to evaluate the full potential of nucleoside analogs as treatment or prophylaxis of viral respiratory infections and to develop effective antivirals that are orally bioavailable.",2020,"In vivo , remdesivir showed therapeutic and prophylactic effects in animal models of EBOV, MERS-CoV, SARS-CoV, and SARS-CoV-2 infection.",['patients with COVID-19'],['placebo'],"['EBOV, MERS-CoV, SARS-CoV, and SARS-CoV-2 infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0949892', 'cui_str': 'Ebolavirus'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.0456724,"In vivo , remdesivir showed therapeutic and prophylactic effects in animal models of EBOV, MERS-CoV, SARS-CoV, and SARS-CoV-2 infection.","[{'ForeName': 'Jakob J', 'Initials': 'JJ', 'LastName': 'Malin', 'Affiliation': 'Department I of Internal Medicine, Division of Infectious Diseases, University of Cologne, Cologne, Germany jakob.malin@uk-koeln.de.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Suárez', 'Affiliation': 'Department I of Internal Medicine, Division of Infectious Diseases, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Priesner', 'Affiliation': 'Department I of Internal Medicine, Division of Infectious Diseases, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Fätkenheuer', 'Affiliation': 'Department I of Internal Medicine, Division of Infectious Diseases, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Rybniker', 'Affiliation': 'Department I of Internal Medicine, Division of Infectious Diseases, University of Cologne, Cologne, Germany.'}]",Clinical microbiology reviews,['10.1128/CMR.00162-20']
2784,33055247,Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial.,"OBJECTIVE


To assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women.
DESIGN


Parallel group randomised controlled trial.
SETTING


23 community and secondary care centres providing continence care in Scotland and England.
PARTICIPANTS


600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300 were randomised to PFMT plus electromyographic biofeedback and 300 to PFMT alone.
INTERVENTIONS


Participants in both groups were offered six appointments with a continence therapist over 16 weeks. Participants in the biofeedback PFMT group received supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback during clinic appointments and at home. The PFMT group received supervised PFMT and a home PFMT programme. PFMT programmes were progressed over the appointments.
MAIN OUTCOME MEASURES


The primary outcome was self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity) at 24 months. Secondary outcomes were cure or improvement, other pelvic floor symptoms, condition specific quality of life, women's perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years.
RESULTS


Mean ICIQ-UI SF scores at 24 months were 8.2 (SD 5.1, n=225) in the biofeedback PFMT group and 8.5 (SD 4.9, n=235) in the PFMT group (mean difference -0.09, 95% confidence interval -0.92 to 0.75, P=0.84). Biofeedback PFMT had similar costs (mean difference £121 ($154; €133), -£409 to £651, P=0.64) and quality adjusted life years (-0.04, -0.12 to 0.04, P=0.28) to PFMT. 48 participants reported an adverse event: for 23 this was related or possibly related to the interventions.
CONCLUSIONS


At 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups. Routine use of electromyographic biofeedback with PFMT should not be recommended. Other ways of maximising the effects of PFMT should be investigated.
TRIAL REGISTRATION


ISRCTN57756448.",2020,At 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups.,"['23 community and secondary care centres', 'stress or mixed urinary incontinence in women', 'urinary incontinence in women', '48 participants', '600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300']","['pelvic floor muscle training with and without electromyographic biofeedback', 'PFMT', 'electromyographic biofeedback with PFMT', 'PFMT plus electromyographic biofeedback and 300 to PFMT alone', 'supervised PFMT and a home PFMT programme', 'pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone', 'supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback']","['severity of urinary incontinence', ""cure or improvement, other pelvic floor symptoms, condition specific quality of life, women's perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years"", 'quality adjusted life years', 'self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity', 'Mean ICIQ-UI SF scores', 'adverse event']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0204624', 'cui_str': 'Electromyographic biofeedback'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4544471', 'cui_str': 'International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",600.0,0.168684,At 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups.,"[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hagen', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow G4 0BA, UK s.hagen@gcu.ac.uk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stratton', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Sergenson', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Bugge', 'Affiliation': 'Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dean', 'Affiliation': 'College of Medicine and Health, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hay-Smith', 'Affiliation': 'Rehabilitation Teaching and Research Unit, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Kilonzo', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dimitrova', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Fattah', 'Affiliation': ""Aberdeen Centre for Women's Health Research, University of Aberdeen, Foresterhill, Aberdeen, UK.""}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Agur', 'Affiliation': 'Crosshouse Hospital, NHS Ayrshire and Arran, Crosshouse, Kilmarnock, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Booth', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Cathryn', 'Initials': 'C', 'LastName': 'Glazener', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Guerrero', 'Affiliation': 'Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Louise R', 'Initials': 'LR', 'LastName': 'Williams', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'McClurg', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m3719']
2785,33055544,"The Effect of Gum Chewing on Abdominal Pain and Nausea Caused by Polyethylene Glycol Solution Used for Intestinal Cleansing Before Colonoscopy: An Endoscopist-Blinded, Randomized Controlled Trial.","Gum chewing is known to have a positive effect on intestinal motility. Most studies have examined its effect on ileus, but there has been no discussion of the effects of polyethylene glycol used in preparation for colonoscopy. The purpose of this study was to determine the effect of gum chewing on abdominal pain and nausea caused by polyethylene glycol solution used for intestinal cleansing before colonoscopy. The study was planned as a single-center, randomized, controlled experimental study. The research sample was determined using power analysis (n = 60). Consecutive patients undergoing colonoscopy were randomized into the experimental and control groups. Patients in the gum group chewed mint-flavored sugar-free gum for 20 minutes every 2 hours until the start of colonoscopy after consuming 2 L of polyethylene glycol solution. Patients in the control group drank only polyethylene glycol solution. Examination of precolonoscopy pain and nausea revealed a statistically significant difference in the gum chewing group (p < .05). Patients using sugar-free gum experienced statistically significant fewer problems after colonoscopy. Gum chewing had a positive effect on abdominal pain and nausea. There are no drawbacks to presolution chewing, and it may be recommended for patients.",2020,Examination of precolonoscopy pain and nausea revealed a statistically significant difference in the gum chewing group (p < .05).,['Consecutive patients undergoing colonoscopy'],"['gum chewing', 'gum group chewed mint-flavored sugar-free gum', 'polyethylene glycol solution', 'Polyethylene Glycol Solution', 'Gum chewing', 'control group drank only polyethylene glycol solution', 'polyethylene glycol', 'Gum Chewing']","['Abdominal Pain and Nausea', 'abdominal pain and nausea', 'precolonoscopy pain and nausea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0452249', 'cui_str': 'Mint'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.0639332,Examination of precolonoscopy pain and nausea revealed a statistically significant difference in the gum chewing group (p < .05).,"[{'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Aydin Sayilan', 'Affiliation': 'Aylin Aydin Sayilan, PhD, is Assistant Professor, Surgical Nursing Department, The Faculty of Health Sciences, Kırklareli University, Kırklareli, Turkey. Ezgi Seyhan AK, PhD, is Assistant Professor, Surgical Nursing Department, Florence Nightingale Nursing Faculty, Istanbul University-Cerrahpasa, Istanbul, Turkey. Zeynep Temiz, PhD, is Assistant Professor, Surgical Nursing Department, Faculty of Health Sciences, Artvin Coruh University, Artvin, Turkey. Seher Deniz Öztekin, PhD, is Prof. Dr., Surgical Nursing Department, Florence Nightingale Nursing Faculty, Istanbul University-Cerrahpasa, Istanbul, Turkey. Sevgi Colak, RN, is Nurse, Endoscopy Unit, Luleburgaz State Hospital, Kırklareli, Turkey. Okay Pirti, is Operator Dr., Endoscopy Unit, Luleburgaz State Hospital, Kırklareli, Turkey.'}, {'ForeName': 'Ezgi', 'Initials': 'E', 'LastName': 'Seyhan Ak', 'Affiliation': ''}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Temiz', 'Affiliation': ''}, {'ForeName': 'Seher Deniz', 'Initials': 'SD', 'LastName': 'Öztekin', 'Affiliation': ''}, {'ForeName': 'Sevgi', 'Initials': 'S', 'LastName': 'Colak', 'Affiliation': ''}, {'ForeName': 'Okay', 'Initials': 'O', 'LastName': 'Pirti', 'Affiliation': ''}]",Gastroenterology nursing : the official journal of the Society of Gastroenterology Nurses and Associates,['10.1097/SGA.0000000000000497']
2786,33055565,Endoscopic Sphenopalatine Ganglion Block Efficacy in the Management of Periorbital Edema and Ecchymosis After Septorhinoplasty.,"AIM


This study aims to evaluate the efficacy of sphenopalatine ganglion block (SPGB) on postoperative edema and ecchymosis for the patients undergoing septorhinoplasty (SRP).
METHODS


In the study, a total number of 55 participant patients (40% male and 60% female, aged between 18 and 42 years) undergoing hump resection and osteotomies were allocated into 2 groups. The SPGB (+) group consisted of 27 patients who underwent SPGB, while the SPGB (-) group consisted of 28 patients who underwent SRP without SPGB. On the first, third, and seventh postoperative days (POD1, POD3, POD7), the score marks of periorbital edema and ecchymosis of the patients were evaluated. Additionally, postoperative upper eyelid edema and upper eyelid ecchymosis as well as lower eyelid edema, and lower eyelid ecchymosis on POD1, POD3, POD7 were evaluated. A comparison with regard to intraoperative bleeding, surgical field, and operation time between the 2 groups was also conducted.
RESULTS


Upper eyelid edema, upper eyelid ecchymosis, lower eyelid edema, lower eyelid ecchymosis on POD 1, 3, 7 were found to be significantly lower in SPGB (+) group in comparison to SPGB (-) group (P < 0.001). Intraoperative blood loss and surgical field were found to be significantly lower in SPGB group (+) than in SPGB (-) group (P < 0.00). The operation time was not found statistically significant between the 2 groups (P = 0.212).
CONCLUSION


Sphenopalatine ganglion block is a safe and effective way of reducing postoperative edema and ecchymosis after SRP. Besides, it provides a better surgical field and reduced bleeding intraoperatively.",2020,Intraoperative blood loss and surgical field were found to be significantly lower in SPGB group (+) than in SPGB (-) group (P < 0.00).,"['patients undergoing septorhinoplasty (SRP', '55 participant patients (40% male and 60% female, aged between 18 and 42 years) undergoing hump resection and osteotomies', 'Periorbital Edema and Ecchymosis After Septorhinoplasty']","['sphenopalatine ganglion block (SPGB', 'SRP without SPGB', 'Endoscopic Sphenopalatine Ganglion Block Efficacy', 'Sphenopalatine ganglion block']","['intraoperative bleeding, surgical field, and operation time', 'seventh postoperative days (POD1, POD3, POD7), the score marks of periorbital edema and ecchymosis', 'operation time', 'Intraoperative blood loss and surgical field', 'lower eyelid edema, and lower eyelid ecchymosis on POD1, POD3, POD7', 'postoperative edema and ecchymosis', 'Upper eyelid edema, upper eyelid ecchymosis, lower eyelid edema, lower eyelid ecchymosis', 'postoperative upper eyelid edema and upper eyelid ecchymosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0189054', 'cui_str': 'Rhinoseptoplasty'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0151205', 'cui_str': 'Periorbital edema'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}]","[{'cui': 'C0394799', 'cui_str': 'Injection of anesthetic agent into sphenopalatine ganglion'}, {'cui': 'C0189054', 'cui_str': 'Rhinoseptoplasty'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0151205', 'cui_str': 'Periorbital edema'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3839997', 'cui_str': 'Edema of lower eyelid'}, {'cui': 'C0229258', 'cui_str': 'Lower eyelid structure'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C3839407', 'cui_str': 'Edema of upper eyelid'}, {'cui': 'C0585636', 'cui_str': 'Upper eyelid structure'}]",,0.0107683,Intraoperative blood loss and surgical field were found to be significantly lower in SPGB group (+) than in SPGB (-) group (P < 0.00).,"[{'ForeName': 'Neslihan', 'Initials': 'N', 'LastName': 'Sari', 'Affiliation': 'Otorhinolaryngology Clinic, Kiziltepe Goverment Hospital,Kiziltepe/Mardin, Turkey.'}, {'ForeName': 'Ersin', 'Initials': 'E', 'LastName': 'Uysal', 'Affiliation': 'Department of Technique, Vocational High School, Dicle University, Diyarbakir, Turkey.'}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000007189']
2787,33055576,Keeping Each Other Accountable: Social Strategies for Smoking Cessation and Healthy Living in Vietnamese American Men.,"Vietnamese American males have high smoking rates. This study explored social support mechanisms provided by lay health workers (LHWs) and family members through a smoking cessation intervention. Eight focus groups (N = 54) were conducted in Vietnamese stratified by intervention arms (Tobacco [experimental] and healthy living [control]) with 18 smokers, 18 family members, and 18 LHWs. Smokers reported feeling more accountable for their health behaviors, and smoking changes were reinforced by family members, peers, and LHWs through conversations facilitated during and outside the program. Culturally appropriate interventions with multiple social support mechanisms may reduce smoking in minority populations.",2020,This study explored social support mechanisms provided by lay health workers (LHWs) and family members through a smoking cessation intervention.,"['lay health workers (LHWs) and family members through a smoking cessation intervention', 'Vietnamese American Men', 'Vietnamese American males']",['Vietnamese stratified by intervention arms (Tobacco [experimental] and healthy living [control'],[],"[{'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C4505363', 'cui_str': 'Vietnamese Americans'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],54.0,0.00986097,This study explored social support mechanisms provided by lay health workers (LHWs) and family members through a smoking cessation intervention.,"[{'ForeName': 'Jazmine D', 'Initials': 'JD', 'LastName': 'Kenny', 'Affiliation': 'Public Health, University of California, Merced (Drs Kenny and Burke); and Psychiatry, University of California San Francisco, San Francisco (Drs Tsoh, Nguyen, and Le).'}, {'ForeName': 'Janice Y', 'Initials': 'JY', 'LastName': 'Tsoh', 'Affiliation': ''}, {'ForeName': 'Bang H', 'Initials': 'BH', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Khanh', 'Initials': 'K', 'LastName': 'Le', 'Affiliation': ''}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Burke', 'Affiliation': ''}]",Family & community health,['10.1097/FCH.0000000000000270']
2788,33055579,"Cognitive Improvement After Cochlear Implantation in Older Adults With Severe or Profound Hearing Impairment: A Prospective, Longitudinal, Controlled, Multicenter Study.","OBJECTIVE


To compare the cognitive evolution of older adults with severe or profound hearing impairment after cochlear implantation with that of a matched group of older adults with severe hearing impairment who do not receive a cochlear implant (CI).
DESIGN


In this prospective, longitudinal, controlled, and multicenter study, 24 older CI users were included in the intervention group and 24 adults without a CI in the control group. The control group matched the intervention group in terms of gender, age, formal education, cognitive functioning, and residual hearing. Assessments were made at baseline and 14 months later. Primary outcome measurements included the change in the total score on the Repeatable Battery for the Assessment of Neuropsychological Status for Hearing impaired individuals score and on its subdomain score to assess cognitive evolution in both groups. Secondary outcome measurements included self-reported changes in sound quality (Hearing Implant Sound Quality Index), self-perceived hearing disability (Speech, Spatial, and Qualities of Hearing Scale), states of anxiety and depression (Hospital Anxiety and Depression Scale), and level of negative affectivity and social inhibition (Type D questionnaire).
RESULTS


Improvements of the overall cognitive functioning (p = 0.05) and the subdomain ""Attention"" (p = 0.02) were observed after cochlear implantation in the intervention group; their scores were compared to the corresponding scores in the control group. Significant positive effects of cochlear implantation on sound quality and self-perceived hearing outcomes were found in the intervention group. Notably, 20% fewer traits of Type D personalities were measured in the intervention group after cochlear implantation. In the control group, traits of Type D personalities increased by 13%.
CONCLUSION


Intervention with a CI improved cognitive functioning (domain Attention in particular) in older adults with severe hearing impairment compared to that of the matched controls with hearing impairment without a CI. However, older CI users did not, in terms of cognition, bridge the performance gap with adults with normal hearing after 1 year of CI use. The fact that experienced, older CI users still present subnormal cognitive functioning may highlight the need for additional cognitive rehabilitation in the long term after implantation.",2020,"RESULTS


Improvements of the overall cognitive functioning (p = 0.05) and the subdomain ""Attention"" (p = 0.02) were observed after cochlear implantation in the intervention group; their scores were compared to the corresponding scores in the control group.","['older adults with severe hearing impairment', '24 older CI users were included in the intervention group and 24 adults without a CI in the control group', 'Older Adults With Severe or Profound Hearing Impairment', 'older adults with severe or profound hearing impairment after cochlear implantation with that of a matched group of older adults with severe hearing impairment who do not receive a cochlear implant (CI']",['cochlear implantation'],"['traits of Type D personalities', 'subdomain ""Attention', 'overall cognitive functioning', 'self-reported changes in sound quality (Hearing Implant Sound Quality Index), self-perceived hearing disability (Speech, Spatial, and Qualities of Hearing Scale), states of anxiety and depression (Hospital Anxiety and Depression Scale), and level of negative affectivity and social inhibition (Type D questionnaire', 'change in the total score on the Repeatable Battery for the Assessment of Neuropsychological Status for Hearing impaired individuals score and on its subdomain score to assess cognitive evolution', 'cognitive functioning', 'Cognitive Improvement', 'sound quality and self-perceived hearing outcomes']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3874334', 'cui_str': 'Severe hearing loss'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439808', 'cui_str': 'Profound'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0302559', 'cui_str': 'Implantation of cochlear prosthetic device'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0302559', 'cui_str': 'Implantation of cochlear prosthetic device'}]","[{'cui': 'C3658239', 'cui_str': 'Personality Type D'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0848765', 'cui_str': 'Hearing disability'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",24.0,0.0658945,"RESULTS


Improvements of the overall cognitive functioning (p = 0.05) and the subdomain ""Attention"" (p = 0.02) were observed after cochlear implantation in the intervention group; their scores were compared to the corresponding scores in the control group.","[{'ForeName': 'Griet', 'Initials': 'G', 'LastName': 'Mertens', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Andries', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Annes J', 'Initials': 'AJ', 'LastName': 'Claes', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Vedat', 'Initials': 'V', 'LastName': 'Topsakal', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Van de Heyning', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Van Rompaey', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Miryam', 'Initials': 'M', 'LastName': 'Calvino', 'Affiliation': 'Department of Otolaryngology, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Sanchez Cuadrado', 'Affiliation': 'Department of Otolaryngology, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Muñoz', 'Affiliation': 'Department of Otolaryngology, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Gavilán', 'Affiliation': 'Department of Otolaryngology, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Bieńkowska', 'Affiliation': 'World Hearing Center, Institute of Physiology and Pathology of Hearing, Warsaw/Kajetany, Poland.'}, {'ForeName': 'Weronika', 'Initials': 'W', 'LastName': 'Świerniak', 'Affiliation': 'World Hearing Center, Institute of Physiology and Pathology of Hearing, Warsaw/Kajetany, Poland.'}, {'ForeName': 'Piotr Henryk', 'Initials': 'PH', 'LastName': 'Skarżyński', 'Affiliation': 'World Hearing Center, Institute of Physiology and Pathology of Hearing, Warsaw/Kajetany, Poland.'}, {'ForeName': 'Henryk', 'Initials': 'H', 'LastName': 'Skarżyński', 'Affiliation': 'World Hearing Center, Institute of Physiology and Pathology of Hearing, Warsaw/Kajetany, Poland.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Tapper', 'Affiliation': 'Yorkshire Auditory Implant Service, Bradford Royal Infirmary, Bradford, United Kingdom.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Killan', 'Affiliation': 'Yorkshire Auditory Implant Service, Bradford Royal Infirmary, Bradford, United Kingdom.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Ridgwell', 'Affiliation': 'Yorkshire Auditory Implant Service, Bradford Royal Infirmary, Bradford, United Kingdom.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'McGowan', 'Affiliation': 'Yorkshire Auditory Implant Service, Bradford Royal Infirmary, Bradford, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Raine', 'Affiliation': 'Yorkshire Auditory Implant Service, Bradford Royal Infirmary, Bradford, United Kingdom.'}, {'ForeName': 'Dayse', 'Initials': 'D', 'LastName': 'Tavora-Vieira', 'Affiliation': 'Otolaryngology, Head & Neck Surgery, Medical School, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Marino', 'Affiliation': 'Otolaryngology, Head & Neck Surgery, Medical School, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Aanand', 'Initials': 'A', 'LastName': 'Acharya', 'Affiliation': 'Otolaryngology, Head & Neck Surgery, Medical School, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Lassaletta', 'Affiliation': 'Department of Otolaryngology, Hospital Universitario La Paz, Madrid, Spain.'}]",Ear and hearing,['10.1097/AUD.0000000000000962']
2789,32981554,"Shared decision making, aggression, and coercion in inpatients with schizophrenia.","BACKGROUND


The present study aimed at answering three research questions: (a) Does shared decision making (SDM) yield similar effects for patients with involuntary admission or incidents of aggression compared to patients with voluntary admission or without incidents of aggression? (b) Does SDM reduce the number of patients with incidents of aggression and the use of coercive measures? (c) Does the use of coercion have a negative impact on patients' perceived involvement in decision making?
METHODS


We used data from the cluster-randomized SDM-PLUS trial in which patients with schizophrenia or schizoaffective disorder in 12 acute psychiatric wards of 4 German psychiatric hospitals either received an SDM-intervention or treatment as usual. In addition, data on aggression and coercive measures were retrospectively obtained from patients' records.
RESULTS


The analysis included n = 305 inpatients. Patient aggression as well as coercive measures mostly took place in the first days of the inpatient stay and were seldom during the study phase of the SDM-PLUS trial.Patients who had been admitted involuntarily or showed incidents of aggression profited similarly from the intervention with regard to perceived involvement, adherence, and treatment satisfaction compared to patients admitted voluntarily or without incidents of aggression. The intervention showed no effect on patient aggression and coercive measures. Having previously experienced coercive measures did not predict patients' rating of perceived involvement.
CONCLUSION


Further research should focus on SDM-interventions taking place in the very first days of inpatients treatment and potential beneficial long effects of participatory approaches that may not be measurable during the current inpatient stay.",2020,"Patients who had been admitted involuntarily or showed incidents of aggression profited similarly from the intervention with regard to perceived involvement, adherence, and treatment satisfaction compared to patients admitted voluntarily or without incidents of aggression.","['patients with schizophrenia or schizoaffective disorder in 12 acute psychiatric wards of 4 German psychiatric hospitals either received an', 'patients with involuntary admission or incidents of aggression compared to patients with voluntary admission or without incidents of aggression', 'inpatients with schizophrenia', 'n\xa0=\xa0305 inpatients', 'Patients who had been admitted involuntarily or showed incidents of aggression profited similarly from the intervention with regard to']",['SDM-intervention or treatment as usual'],"['patient aggression and coercive measures', 'perceived involvement, adherence, and treatment satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C1277270', 'cui_str': 'Involuntary admission'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0376348', 'cui_str': 'Voluntary admission'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",305.0,0.052904,"Patients who had been admitted involuntarily or showed incidents of aggression profited similarly from the intervention with regard to perceived involvement, adherence, and treatment satisfaction compared to patients admitted voluntarily or without incidents of aggression.","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Hamann', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar, Technische Universität München, München, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'John', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar, Technische Universität München, München, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Holzhüter', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar, Technische Universität München, München, Germany.'}, {'ForeName': 'Spyridon', 'Initials': 'S', 'LastName': 'Siafis', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar, Technische Universität München, München, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brieger', 'Affiliation': 'kbo Isar-Amper-Klinikum München Ost, Haar, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Heres', 'Affiliation': 'kbo Isar-Amper-Klinikum München Ost, Haar, Germany.'}]",European psychiatry : the journal of the Association of European Psychiatrists,['10.1192/j.eurpsy.2020.88']
2790,32991429,Optimal induction chemotherapeutic regimen followed by concurrent chemotherapy plus intensity-modulated radiotherapy as first-line therapy for locoregionally advanced nasopharyngeal carcinoma.,"For patients with locoregionally advanced nasopharyngeal carcinoma (NPC), induction chemotherapy (IC) regimens based on TPF (docetaxel, cisplatin, and 5-fluorouracil), TP (docetaxel and cisplatin), and GP (gemcitabine and cisplatin) have shown excellent survival outcomes as the first-line therapy; however, no trials comparing the efficacy and safety of TPF, TP, and GP have been reported. We report 2 phase II trials comparing the treatment outcomes and side effects of 3 different IC regimens followed by concurrent chemoradiotherapy in locoregionally advanced patients with NPC.A total of 206 locoregionally advanced patients with NPC treated with a combination treatment from January 2012 to January 2014 were enrolled in the 2 studies. The patients received TPF-, TP-, and GP-based IC regimens every 3 weeks, followed by intensity-modulated radiotherapy and concurrent therapy with cisplatin every 3 weeks.After a median follow-up duration of 47 months (10-60 months), the 3-year local recurrence-free survival, regional recurrence-free survival, distant metastases-free survival, progression-free survival, and overall survival rates were 96.4%, 100%, 87.7%, 86%, and 94.7% in the TPF arm; 91.7%, 95.9%, 91.9%, 85.2%, and 92% in the TP arm; 98.6%, 100%, 89.0%, 87.6%, and 89.2% in the GP arm. The survival differences among the 3 arms were not statistically significant (P > .05). The multivariate analysis demonstrated that the IC regimen was not an independent prognostic factor for any survival outcomes. The patients in the TP arm experienced significantly lower grade 3/4 toxicities than the patients in the other 2 arms.TP-based IC regimen has similar efficacy compared with TPF- and GP-based IC regimens; however, TP-based IC regimen has a lower toxicity profile.",2020,The survival differences among the 3 arms were not statistically significant (P > .05).,"['locoregionally advanced nasopharyngeal carcinoma', 'patients with locoregionally advanced nasopharyngeal carcinoma (NPC), induction chemotherapy (IC) regimens based on', 'locoregionally advanced patients with NPC.A total of 206 locoregionally advanced patients with NPC treated with a combination treatment from January 2012 to January 2014 were enrolled in the 2 studies']","['chemotherapy plus intensity-modulated radiotherapy', 'concurrent chemoradiotherapy', 'TPF-, TP-, and GP-based IC regimens every 3 weeks, followed by intensity-modulated radiotherapy and concurrent therapy with cisplatin', 'TPF (docetaxel, cisplatin, and 5-fluorouracil), TP (docetaxel and cisplatin), and GP (gemcitabine and cisplatin']","['grade 3/4 toxicities', '3-year local recurrence-free survival, regional recurrence-free survival, distant metastases-free survival, progression-free survival, and overall survival rates', 'toxicity profile', 'survival differences']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",206.0,0.0452499,The survival differences among the 3 arms were not statistically significant (P > .05).,"[{'ForeName': 'Fangzheng', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Chuner', 'Affiliation': 'Department of Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Lei', 'Affiliation': 'Department of Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Fengqin', 'Affiliation': 'Department of Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhimin', 'Affiliation': 'Department of Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences.'}, {'ForeName': 'Sun', 'Initials': 'S', 'LastName': 'Quanquan', 'Affiliation': 'Department of Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Tongxin', 'Affiliation': 'Department of Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences.'}, {'ForeName': 'Fu', 'Initials': 'F', 'LastName': 'Zhenfu', 'Affiliation': 'Department of Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Yangming', 'Affiliation': ""Department of Digital Earth, Institute of Remote Sensing and Digital Earth, CAS, Beijing, People's Republic of China.""}]",Medicine,['10.1097/MD.0000000000022283']
2791,32666918,Changes in the objective measures of sleep between the initial nights of menses and the nights during the midfollicular phase of the menstrual cycle in collegiate female athletes.,"STUDY OBJECTIVES


Sleep is an important recovery period for athletes. Women, including athletes, have reported sleep disturbances around menses. Thus, the aim of this study was to assess the changes in objective sleep parameters in the nights during menses and in the midfollicular phase of the menstrual cycle of young female athletes.
METHODS


Female collegiate athletes with regular menstrual cycles were recruited. The participants underwent home electroencephalogram monitoring during the first and second nights after the onset of menses (M1 and M2, respectively) and during one night between the 7th and the 10th night after menses onset (midfollicular phase).
RESULTS


Data from 45 athletes were analyzed. The total sleep time was significantly reduced, and sleep onset latency was significantly prolonged in M2 compared with those in the night during the midfollicular phase. Sleep efficiency was significantly reduced in M1 compared with that in the night during the midfollicular phase. Changes in the percentage of deep sleep across menstrual cycles differed among the participants with and without menstrual symptoms or concerns for sanitary products; moreover, such participants spent a lower percentage of time in deep sleep in M1 compared with the other nights.
CONCLUSIONS


Collegiate female athletes with regular menstrual cycles are likely to have trouble falling asleep, tend to sleep less, and when concerned about sanitary products, have less deep sleep during menses. Even in young female athletes with regular menstrual cycles, sleep can be disturbed during menses. Interventions to restore or improve sleep should be considered.",2020,"The total sleep time was significantly reduced, and sleep onset latency was significantly prolonged in M2 compared with those in the night during the midfollicular phase.","['Female collegiate athletes with regular menstrual cycles were recruited', 'collegiate female athletes', 'young female athletes', 'young female athletes with regular menstrual cycles', 'Collegiate female athletes with regular menstrual cycles', 'Data from 45 athletes were analyzed', 'athletes']",[],"['Sleep efficiency', 'objective sleep parameters', 'sleep onset latency', 'total sleep time']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],"[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",45.0,0.0224637,"The total sleep time was significantly reduced, and sleep onset latency was significantly prolonged in M2 compared with those in the night during the midfollicular phase.","[{'ForeName': 'Natsue', 'Initials': 'N', 'LastName': 'Koikawa', 'Affiliation': 'Japanese Center for Research on Women in Sports, Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Takami', 'Affiliation': 'Graduate School of Health and Sports Science, Juntendo University, Chiba, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Department of Obstetrics and Gynecology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Fusae', 'Initials': 'F', 'LastName': 'Kawana', 'Affiliation': 'Cardiovascular Respiratory Sleep Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nanako', 'Initials': 'N', 'LastName': 'Shiroshita', 'Affiliation': 'Cardiovascular Respiratory Sleep Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Etsuko', 'Initials': 'E', 'LastName': 'Ogasawara', 'Affiliation': 'Japanese Center for Research on Women in Sports, Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Kasai', 'Affiliation': 'Cardiovascular Respiratory Sleep Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8692']
2792,31714895,L-Citrulline increases nitric oxide and improves control in obese asthmatics.,"BACKGROUNDThe airways of obese asthmatics have been shown to be NO deficient, and this contributes to airway dysfunction and reduced response to inhaled corticosteroids. In cultured airway epithelial cells, L-citrulline, a precursor of L-arginine recycling and NO formation, has been shown to prevent asymmetric dimethyl arginine-mediated (ADMA-mediated) NO synthase (NOS2) uncoupling, restoring NO and reducing oxidative stress.METHODSIn a proof-of-concept, open-label pilot study in which participants were analyzed before and after treatment, we hypothesized that 15 g/d L-citrulline for 2 weeks would (a) increase the fractional excretion of NO (FeNO), (b) improve asthma control, and (c) improve lung function. To this end, we recruited obese (BMI >30) asthmatics on controller therapy, with a baseline FeNO of ≤30 ppb from the University of Colorado Medical Center and Duke University Health System.RESULTSA total of 41 subjects with an average FeNO of 17 ppb (95% CI, 15-19) and poorly controlled asthma (average asthma control questionnaire [ACQ] 1.5 [95% CI, 1.2-1.8]) completed the study. Compared with baseline, L-citrulline increased whereas ADMA and arginase concentration did not (values represent the mean Δ and 95% CI): plasma L-citrulline (190 μM, 84-297), plasma L-arginine (67 μM, 38-95), and plasma L-arginine/ADMA (ratio 117, 67-167). FeNO increased by 4.2 ppb (1.7-6.7 ppb); ACQ decreased by -0.46 (-0.67 to 0.27 points); the forced vital capacity and forced exhalation volume in 1 second, respectively, changed by 86 ml (10-161 ml) and 52 ml (-11 to 132 ml). In a secondary analysis, the greatest FEV1 increments occurred in those subjects with late-onset asthma (>12 years) (63 ml [95% CI, 1-137]), in females (80 ml [95% CI, 5-154]), with a greater change seen in late-onset females (100 ml, [95% CI, 2-177]). The changes in lung function or asthma control were not significantly associated with the changes before and after treatment in L-arginine/ADMA or FeNO.CONCLUSIONShort-term L-citrulline treatment improved asthma control and FeNO levels in obese asthmatics with low or normal FeNO. Larger FEV1 increments were observed in those with late-onset asthma and in females.TRIAL REGISTRATIONClinicalTrials.gov NCT01715844.FUNDINGNIH NHLBI R01 HL146542-01.",2019,The changes in lung function or asthma control were not significantly associated with the changes before and after treatment in L-arginine/ADMA or FeNO.CONCLUSIONShort-term L-citrulline treatment improved asthma control and FeNO levels in obese asthmatics with low or normal FeNO.,"['obese asthmatics with low or normal FeNO', 'obese asthmatics', 'total of 41 subjects with an average FeNO of 17 ppb (95% CI, 15-19) and poorly controlled asthma (average asthma control questionnaire [ACQ] 1.5 [95% CI, 1.2-1.8]) completed the study', 'recruited obese (BMI >30) asthmatics on controller therapy, with a baseline FeNO of ≤30 ppb from the University of Colorado Medical Center and Duke University Health System']",['L-Citrulline'],"['fractional excretion of NO (FeNO), (b) improve asthma control, and (c) improve lung function', 'lung function or asthma control', 'greatest FEV1 increments', 'NO synthase (NOS2) uncoupling, restoring NO and reducing oxidative stress', 'plasma L-arginine/ADMA', 'asthma control and FeNO levels', 'ADMA and arginase concentration', 'FeNO', 'Larger FEV1 increments', 'forced vital capacity and forced exhalation volume', 'ACQ']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032441', 'cui_str': 'Polybrominated biphenyl'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C1512090', 'cui_str': 'Dukes staging system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0008864', 'cui_str': 'Citrulline'}]","[{'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0132555', 'cui_str': 'Nitric-oxide synthase'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003762', 'cui_str': 'Arginase'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}]",41.0,0.148188,The changes in lung function or asthma control were not significantly associated with the changes before and after treatment in L-arginine/ADMA or FeNO.CONCLUSIONShort-term L-citrulline treatment improved asthma control and FeNO levels in obese asthmatics with low or normal FeNO.,"[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Holguin', 'Affiliation': 'Department of Medicine, University of Colorado Medical School, Aurora, Colorado, USA.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Grasemann', 'Affiliation': 'Department of Pediatrics, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Medicine, University of Colorado Medical School, Aurora, Colorado, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Winnica', 'Affiliation': 'Department of Medicine, University of Colorado Medical School, Aurora, Colorado, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Wasil', 'Affiliation': 'Department of Medicine, University of Colorado Medical School, Aurora, Colorado, USA.'}, {'ForeName': 'Vong', 'Initials': 'V', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, University of Colorado Medical School, Aurora, Colorado, USA.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Cruse', 'Affiliation': 'Department of Medicine, University of Colorado Medical School, Aurora, Colorado, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Perez', 'Affiliation': 'Department of Medicine, University of Colorado Medical School, Aurora, Colorado, USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Coleman', 'Affiliation': 'Department of Medicine, University of Colorado Medical School, Aurora, Colorado, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Scialla', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Loretta G', 'Initials': 'LG', 'LastName': 'Que', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.'}]",JCI insight,['10.1172/jci.insight.131733']
2793,33061555,"Operation, Effectiveness, and Limitations of Continuous Serratus Anterior Plane Blocks for Thoracoscopic Surgery in Adults.","Purpose


This randomized, double-blind study evaluated the effectiveness and limitations of continuous serratus anterior plane block (cSAPB) by comparing the effect of cSAPB to patient-controlled intravenous analgesia (PCIA) on postoperative acute pain after thoracoscopic surgery in adults.
Patients and Methods


Sixty-six patients who underwent elective video-assisted thoracoscopic surgery (VATS) were randomly allocated to cSAPB or PCIA groups (n=33 per group) after surgery. For the cSAPB group, patients were treated by an initial does of 20 mL ropivacaine (0.375%), followed by continuous infusion at a rate of 5 mL/h of ropivacaine (0.2%) and a patient-controlled bolus of 5 mL ropivacaine (0.2%). PCIA started with an initial does of 0.03 µg/kg sufentanil, followed by a basal infusion of 0.03 µg/kg/h sufentanil and a patient-controlled bolus of 0.03 µg/kg sufentanil. Visual analog scale (VAS) and other items were examined postoperatively. The area under the curve of VAS-time (AUC VAS-time ) at rest and on coughing in the first 24 hours postoperatively were primary outcomes.
Results


At the first 24 hours postoperatively, patients in the cSAPB group exhibited a smaller AUC VAS-time  at rest (44.0±17.1 vs 68.9±11.8 cm·h,  P <0.001) and AUC VAS-time  on coughing (67.1±8.8 vs 78.0±12.5 cm·h,  P <0.001) compared with those in the PCIA group. The differences in means of VAS score at rest were more than 1.0 cm between the two groups, however, on coughing they were less than 1.0 cm at each observation point. Additionally, patients in the cSAPB group had a longer time to first patient-controlled bolus (15.8±7.6 vs 10.6±8.6 hours,  P =0.011). Furthermore, a higher rank of satisfaction was recorded with patients in the cSAPB group.
Conclusion


cSAPB using PCA devices might be superior to traditional intravenous continuous analgesia, particularly with an advantage of pain relief at rest following VATS operation. Meanwhile, cSAPB lacks a satisfactory analgesic effect on cough.",2020,"The differences in means of VAS score at rest were more than 1.0 cm between the two groups, however, on coughing they were less than 1.0 cm at each observation point.","['postoperative acute pain after thoracoscopic surgery in adults', 'Thoracoscopic Surgery in Adults', 'Patients and Methods\n\n\nSixty-six patients who underwent']","['continuous serratus anterior plane block (cSAPB', 'sufentanil', 'ropivacaine', 'cSAPB to patient-controlled intravenous analgesia (PCIA', 'cSAPB or PCIA', 'elective video-assisted thoracoscopic surgery (VATS']","['higher rank of satisfaction', 'AUC VAS-time  on coughing', 'VAS score', 'smaller AUC VAS-time  at rest', 'pain relief', 'longer time to first patient-controlled bolus', 'Visual analog scale (VAS', 'area under the curve of VAS-time (AUC VAS-time ) at rest and on coughing']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517841', 'cui_str': '66'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",66.0,0.0848936,"The differences in means of VAS score at rest were more than 1.0 cm between the two groups, however, on coughing they were less than 1.0 cm at each observation point.","[{'ForeName': 'Xin-Lu', 'Initials': 'XL', 'LastName': 'Yang', 'Affiliation': ""Department of Anesthesiology, Pain Clinic, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': ""Department of Anesthesiology, Pain Clinic, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Ji-Cheng', 'Initials': 'JC', 'LastName': 'Hu', 'Affiliation': ""Department of Anesthesiology, Pain Clinic, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Pain Clinic, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': ""Department of Anesthesiology, Pain Clinic, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Shu-Hua', 'Initials': 'SH', 'LastName': 'Shu', 'Affiliation': ""Department of Anesthesiology, Pain Clinic, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Wei-de', 'Initials': 'WD', 'LastName': 'Zhou', 'Affiliation': ""Department of Anesthesiology, Pain Clinic, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Chun-Rong', 'Initials': 'CR', 'LastName': 'Tao', 'Affiliation': ""Department of Neurology, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Pain Clinic, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Xiao-Qing', 'Initials': 'XQ', 'LastName': 'Chai', 'Affiliation': ""Department of Anesthesiology, Pain Clinic, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}]",Journal of pain research,['10.2147/JPR.S264139']
2794,33054368,Closure of Iatrogenic Atrial Septal Defect Following Transcatheter Mitral Valve Repair: The Randomized MITHRAS Trial.,,2020,,[],['Transcatheter Mitral Valve Repair'],[],[],"[{'cui': 'C2921039', 'cui_str': 'Transcatheter mitral valve repair'}]",[],,0.0733626,,"[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Lurz', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at Leipzig University, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Unterhuber', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at Leipzig University, Leipzig, Germany.'}, {'ForeName': 'Karl-Philipp', 'Initials': 'KP', 'LastName': 'Rommel', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at Leipzig University, Leipzig, Germany.'}, {'ForeName': 'Karl-Patrik', 'Initials': 'KP', 'LastName': 'Kresoja', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at Leipzig University, Leipzig, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kister', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at Leipzig University, Leipzig, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Besler', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at Leipzig University, Leipzig, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Fengler', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at Leipzig University, Leipzig, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Sandri', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at Leipzig University, Leipzig, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Daehnert', 'Affiliation': 'Department of Pediatric Cardiology, Heart Center Leipzig at Leipzig University, Leipzig, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at Leipzig University, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'von Roeder', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at Leipzig University, Leipzig, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Blazek', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at Leipzig University, Leipzig, Germany.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.051989']
2795,33054367,Comparison of Self-Expanding Bioprostheses for Transcatheter Aortic Valve Replacement in Patients with Symptomatic Severe Aortic Stenosis: The SCOPE 2 Randomized Clinical Trial.,"Background:  There are few randomized trials comparing bioprostheses for transcatheter aortic valve replacement (TAVR), and no trials compared TAVR bioprostheses with supra-annular design. The SCOPE 2 trial was designed to compare the clinical outcomes of the ACURATE neo and CoreValve Evolut valves.  Methods:  SCOPE 2 was a randomized trial performed at 23 centers in 6 countries between April 2017 and April 2019. Patients ≥75 years with an indication for transfemoral TAVR as agreed by the Heart Team were randomly assigned to receive treatment with either the ACURATE neo (n=398) or the CoreValve Evolut bioprostheses (n=398). The primary endpoint, powered for non-inferiority of the ACURATE neo valve, was all-cause death or stroke at 1 year. The key secondary endpoint, powered for superiority of the ACURATE neo valve, was new permanent pacemaker implantation at 30 days.  Results:  Among 796 randomized patients (mean age 83.2±4.3 years; mean STS-PROM score 4.6± 2.9%), clinical follow-up information was available for 778 (98%) patients. Within 1 year, the primary endpoint occurred in 15.8% of patients in the ACURATE neo group and in 13.9% of patients in the CoreValve Evolut group (absolute risk difference 1.8%, upper one-sided 95% confidence limit 6.1%, p=0.0549 for noninferiority). The 30-day rates of new permanent pacemaker implantation were 10.5% in the ACURATE neo group and 18.0% in the CoreValve Evolut group (absolute risk difference -7.5%, 95% confidence interval -12.4 to -2.60, p=0.0027). No significant differences were observed in the components of the primary endpoint. Cardiac death at 30 days (2.8% vs. 0.8%, p=0.03) and 1 year (8.4% vs. 3.9%, p=0.01), and moderate or severe aortic regurgitation at 30 days (10% vs. 3%, p=0.002) were significantly increased in the ACURATE neo group.  Conclusions:  Transfemoral TAVR with the self-expanding ACURATE neo did not meet non-inferiority compared to the self-expanding CoreValve Evolut in terms of all-cause death or stroke at 1 year, and was associated with a lower incidence of new permanent pacemaker implantation. In secondary analyses, the ACURATE neo was associated with more moderate or severe aortic regurgitation at 30 days and cardiac death at 30 days and 1 year.  Clinical Trial Registration:  URL: https://clinicaltrials.gov/ Unique Identifier: NCT03192813.",2020,"Cardiac death at 30 days (2.8% vs. 0.8%, p=0.03) and 1 year (8.4% vs. 3.9%, p=0.01), and moderate or severe aortic regurgitation at 30 days (10% vs. 3%, p=0.002) were significantly increased in the ACURATE neo group.  ","['Patients with Symptomatic Severe Aortic Stenosis', '796 randomized patients', '23 centers in 6 countries between April 2017 and April 2019', 'Patients ≥75 years with an indication for transfemoral TAVR as agreed by the Heart Team']","['Self-Expanding Bioprostheses', 'Transcatheter Aortic Valve Replacement', 'transcatheter aortic valve replacement (TAVR', 'ACURATE neo (n=398) or the CoreValve Evolut bioprostheses']","['moderate or severe aortic regurgitation', '30-day rates of new permanent pacemaker implantation', 'cardiac death', 'Cardiac death', 'non-inferiority of the ACURATE neo valve, was all-cause death or stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003504', 'cui_str': 'Aortic valve regurgitation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",796.0,0.318644,"Cardiac death at 30 days (2.8% vs. 0.8%, p=0.03) and 1 year (8.4% vs. 3.9%, p=0.01), and moderate or severe aortic regurgitation at 30 days (10% vs. 3%, p=0.002) were significantly increased in the ACURATE neo group.  ","[{'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Tamburino', 'Affiliation': 'Department of General Surgery and Medical-Surgical Subspecialties, University of Catania, Catania, Italy.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Bleiziffer', 'Affiliation': 'Department of Department of Cardiothoracic Surgery, Heart-and Diabetes Center Northrhein-Westfalia, Bad Oeynhausen, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Department of Cardiology, Heart Center Leipzig at University Leipzig, Leipzig, Germany.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Scholtz', 'Affiliation': 'Department of interventional Cardiology, Heart-and Diabetes Center Northrhein-Westfalia, Bad Oeynhausen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hildick-Smith', 'Affiliation': 'Department of Cardiology, Brighton & Sussex University Hospitals NHS Trust, Brighton, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cunnington', 'Affiliation': 'Department of Cardiology, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Department of Cardiology, Elisabeth Hospital Essen, Essen, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Barbanti', 'Affiliation': 'Department of Cardio-Thoracic-Vascular Diseases and Transplantation, Azienda Ospedaliero-Universitaria Policlinico ""G. Rodolico-San Marco"", Catania, Italy.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchetché', 'Affiliation': 'Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Garot', 'Affiliation': 'Hôpital Privé Jacques Cartier, Institut Cardio-vasculaire Paris-Sud (ICPS), Ramsay-Santé, Massy, France.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pagnotta', 'Affiliation': 'Department of Cardiovascular Medicine, Humanitas Clinical and Research Center, Milano, Italy.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Gilard', 'Affiliation': 'Department of Cardiology, Brest University Hospital, Brest, France.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bedogni', 'Affiliation': 'Cardiology Department, IRCCS Policlinico San Donato, Milano, Italy.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Belle', 'Affiliation': 'Department of Cardiology, University Hospital, Lille, France.'}, {'ForeName': 'Mariuca', 'Initials': 'M', 'LastName': 'Vasa-Nicotera', 'Affiliation': 'Department of Cardiology, Goethe University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Alaide', 'Initials': 'A', 'LastName': 'Chieffo', 'Affiliation': 'Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Deutsch', 'Affiliation': 'Department of Cardiovascular Surgery, German Heart Centre Munich, Munich, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Kempfert', 'Affiliation': 'Deutsches Herzzentrum Berlin, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Søndergaard', 'Affiliation': 'The Heart Center-Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Butter', 'Affiliation': 'Department of Cardiology, Heart Center Brandenburg in Bernau and Brandenburg Medical School, Germany.'}, {'ForeName': 'Ramiro', 'Initials': 'R', 'LastName': 'Trillo-Nouche', 'Affiliation': 'Servicio de Cardiología, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Lotfi', 'Affiliation': 'Department of Cardiovascular Surgery, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Möllmann', 'Affiliation': 'Department of Cardiology, St. Johannes Hospital, Dortmund, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joner', 'Affiliation': 'Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Munich, Germany.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': 'Department of Cardiology, Heart Center Leipzig at University Leipzig, Leipzig, Germany.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Bogaerts', 'Affiliation': 'Department of Public Health and Primary Care, I-BioStat, KU Leuven, Leuven, Belgium and I-BioStat, Universiteit Hasselt, Hasselt, Belgium.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hengstenberg', 'Affiliation': 'Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Capodanno', 'Affiliation': 'Department of General Surgery and Medical-Surgical Subspecialties, University of Catania, Catania, Italy.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.051547']
2796,33054371,Can Avatar Appearance Influence Physical Activity? User-Avatar Similarity and Proteus Effects on Cardiac Frequency and Step Counts.,"This study combined user-avatar similarity and Proteus effect predictions to incentivize physical activity. 305 participants ran while wearing accelerometers and a heart rate monitor. They were randomly assigned to onscreen motion-capturing avatars displaying either participant or stranger faces dressed in sports or formal clothes. Participants assigned to avatars displaying their own face showed increased cardiac frequency compared with those exposed to avatars with a stranger's face. Relative to the remaining conditions, participants assigned to avatars with their own face also wearing sports clothes showed increased cardiac frequency but participants assigned to avatars with a stranger's face wearing formal clothes showed decreased cardiac frequency. The results imply that user-avatar similarity and the Proteus effect can be harnessed to influence physical activity.",2020,Participants assigned to avatars displaying their own face showed increased cardiac frequency compared with those exposed to avatars with a stranger's face.,['305 participants ran while wearing accelerometers and a heart rate monitor'],['onscreen motion-capturing avatars displaying either participant or stranger faces dressed in sports or formal clothes'],"['Cardiac Frequency and Step Counts', 'cardiac frequency']","[{'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]","[{'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0009072', 'cui_str': 'Garments'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",305.0,0.0167681,Participants assigned to avatars displaying their own face showed increased cardiac frequency compared with those exposed to avatars with a stranger's face.,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Navarro', 'Affiliation': 'CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN), Universitat de Valencia.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Peña', 'Affiliation': 'University of Davis , California.'}, {'ForeName': 'Ausias', 'Initials': 'A', 'LastName': 'Cebolla', 'Affiliation': 'CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN), Universitat de Valencia.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Baños', 'Affiliation': 'CIBER Fisiopatología Obesidad Y Nutrición (CIBEROBN), Instituto Polibienestar, Universitat de Valencia.'}]",Health communication,['10.1080/10410236.2020.1834194']
2797,33054386,Minding the Gap: Effects of an Attention Maintenance Training Program on Driver Calibration.,"OBJECTIVE


The present study examines the effect of an existing driver training program, FOrward Concentration and Attention Learning (FOCAL) on young drivers' calibration, drivers' ability to estimate the length of their in-vehicle glances while driving, using two different measures, normalized difference scores and Brier Scores.
BACKGROUND


Young drivers are poor at maintaining attention to the forward roadway while driving a vehicle. Additionally, drivers may overestimate their attention maintenance abilities. Driver training programs such as FOCAL may train target skills such as attention maintenance but also might serve as a promising way to reduce errors in drivers' calibration of their self-perceived attention maintenance behaviors in comparison to their actual performance.
METHOD


Thirty-six participants completed either FOCAL or a Placebo training program, immediately followed by driving simulator evaluations of their attention maintenance performance. In the evaluation drive, participants navigated four driving simulator scenarios during which their eyes were tracked. In each scenario, participants performed a map task on a tablet simulating an in-vehicle infotainment system.
RESULTS


FOCAL-trained drivers maintained their attention to the forward roadway more and reported better calibration using the normalized difference measure than Placebo-trained drivers. However, the Brier scores did not distinguish the two groups on their calibration.
CONCLUSION


The study implies that FOCAL has the potential to improve not only attention maintenance skills but also calibration of the skills for young drivers.
APPLICATION


Driver training programs may be designed to train not only targeted higher cognitive skills but also driver calibration-both critical for driving safety in young drivers.",2020,"RESULTS


FOCAL-trained drivers maintained their attention to the forward roadway more and reported better calibration using the normalized difference measure than Placebo-trained drivers.",['Thirty-six participants completed either'],"['existing driver training program, FOrward Concentration and Attention Learning (FOCAL', 'FOCAL or a Placebo training program', 'Attention Maintenance Training Program']",['Driver Calibration'],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0336490', 'cui_str': 'Underground or elevated train driver'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}]",36.0,0.0360748,"RESULTS


FOCAL-trained drivers maintained their attention to the forward roadway more and reported better calibration using the normalized difference measure than Placebo-trained drivers.","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Unverricht', 'Affiliation': '6042 Old Dominion University, Norfolk, Virginia, USA.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Yamani', 'Affiliation': '6042 Old Dominion University, Norfolk, Virginia, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': '6042 Old Dominion University, Norfolk, Virginia, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Horrey', 'Affiliation': '14579 AAA Foundation for Traffic Safety, Washington, DC, USA.'}]",Human factors,['10.1177/0018720820965293']
2798,33054601,Hybrid neuromuscular training promotes musculoskeletal adaptations in inactive overweight and obese women: A training-detraining randomized controlled trial.,"This study investigated the effects of a 10-month high-intensity interval-type neuromuscular training programme on musculoskeletal fitness in overweight and obese women. Forty-nine inactive females (36.4 ± 4.4 yrs) were randomly assigned to either a control (N = 21), a training (N = 14, 10 months) or a training-detraining group (N = 14, 5 months training followed by 5 months detraining). Training used progressive loaded fundamental movement patterns with prescribed work-to-rest intervals (1:2, 1:1, 2:1) in a circuit fashion (2-3 rounds). Muscular strength and endurance, flexibility, passive range of motion (PRoM), static balance, functional movement screen (FMS) and bone mass density (BMD) and content (BMC) were measured at pre-, mid-, and post-intervention. Ten months of training induced greater changes than the controls in (i) BMD (+1.9%,  p  < 0.001) and BMC (+1.5%,  p  = 0.023) ii) muscular strength (25%-53%,  p  = 0.001-0.005); iii) muscular endurance (103%-195%,  p  < 0.001); and iv) mobility (flexibility: 40%,  p  < 0.001; PRoM [24%-53%,  p  = 0.001-0.05;]; balance: 175%,  p  = 0.058; FMS: +58%,  p  < 0.001). The response rate to training was exceptionally high (86-100%). Five months of detraining reduced but not abolished training-induced adaptations. These results suggest that a hybrid-type exercise approach integrating endurance-based bodyweight drills with resistance-based alternative modes into a real-world gym setting may promote musculoskeletal fitness in overweight and obese women.",2020,"Ten months of training induced greater changes than the controls in (i) BMD (+1.9%,  p  < 0.001) and BMC (+1.5%,  p  = 0.023) ii) muscular strength (25%-53%,  p  = 0.001-0.005); iii) muscular endurance (103%-195%,  p  < 0.001); and iv) mobility (flexibility: 40%,  ","['inactive overweight and obese women', 'Forty-nine inactive females (36.4\xa0±\xa04.4\xa0yrs', 'overweight and obese women']","['10-month high-intensity interval-type neuromuscular training programme', 'training-detraining group (N\xa0=\xa014, 5\xa0months training followed by 5\xa0months detraining', 'Hybrid neuromuscular training']","['BMC', 'Muscular strength and endurance, flexibility, passive range of motion (PRoM), static balance, functional movement screen (FMS) and bone mass density (BMD) and content (BMC', 'response rate to training', 'muscular strength', 'musculoskeletal fitness', 'iii) muscular endurance']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517761', 'cui_str': '4.4'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}]","[{'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439070', 'cui_str': 'III'}]",,0.0346079,"Ten months of training induced greater changes than the controls in (i) BMD (+1.9%,  p  < 0.001) and BMC (+1.5%,  p  = 0.023) ii) muscular strength (25%-53%,  p  = 0.001-0.005); iii) muscular endurance (103%-195%,  p  < 0.001); and iv) mobility (flexibility: 40%,  ","[{'ForeName': 'Alexios', 'Initials': 'A', 'LastName': 'Batrakoulis', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly , Trikala, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Tsimeas', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly , Trikala, Greece.'}, {'ForeName': 'Chariklia K', 'Initials': 'CK', 'LastName': 'Deli', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly , Trikala, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Vlachopoulos', 'Affiliation': 'College of Life and Environmental Sciences, Sport and Health Sciences, University of Exeter , Exeter, UK.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Ubago-Guisado', 'Affiliation': 'Health and Social Research Center, Universidad De Castilla-La Mancha , Cuenca, Spain.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Poulios', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly , Trikala, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Chatzinikolaou', 'Affiliation': 'School of Physical Education and Sport Sciences, Democritus University of Thrace , Komotini, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Draganidis', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly , Trikala, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Papanikolaou', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly , Trikala, Greece.'}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Georgakouli', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly , Trikala, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Batsilas', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly , Trikala, Greece.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Gracia-Marco', 'Affiliation': 'Faculty of Sport Sciences, Department of Physical Education and Sports, University of Granada , Granada, Spain.'}, {'ForeName': 'Athanasios Z', 'Initials': 'AZ', 'LastName': 'Jamurtas', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly , Trikala, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Fatouros', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly , Trikala, Greece.'}]",Journal of sports sciences,['10.1080/02640414.2020.1830543']
2799,33054635,"The combined effects of probiotics and restricted calorie diet on the anthropometric indices, eating behavior, and hormone levels of obese women with food addiction :  a randomized clinical trial.","BACKGROUND AND AIM


Food addiction (FA) is an important contributor to obesity. Alterations in gut microbiota (GM) diversity and composition have also been proposed to play a pivotal role in obesity pathogenesis. This trial aimed to assess the effects of probiotic supplementation on the anthropometric indices, eating behavior, and hormone levels of obese women with FA.
METHODS


This randomized, double-blind, placebo-controlled clinical trial was conducted among obese women with FA. Participants ( n  = 62) received a restricted calorie diet (RCD) plus either probiotic, or placebo for 12 weeks. Anthropometric measurements, biochemical markers, eating behavior and appetite were assessed during the study period.
RESULTS


Probiotics administration significantly reduced weight, body mass index (BMI), waist circumference (WC), waist to hip ratio (WHR), body fat percentage (BFP), and trunk fat percentage (TFP) compared to the placebo group ( p  < 0.001). Also, a significant improvement was observed in eating behavior in the probiotic group compared to the placebo group ( p  < 0.001).Serum levels of oxytocin increased and NPY decreased significantly in the probiotic group compared to the placebo group ( p  = 0.02,  p  = 0.002, respectively). Moreover, leptin level significantly decreased in the probiotic group compared to the baseline values ( p  < 0.001), while probiotics did not cause a greater significant reduction in leptin level, compared to the placebo group.
CONCLUSION


Multi-probiotic supplementation may have beneficial effects on anthropometric indices, eating behavior, and some appetite-regulating hormones in obese women with FA.  Trial registration:  Iranian Registry of Clinical Trials identifier: IRCT20131228015968N5.",2020,"Moreover, leptin level significantly decreased in the probiotic group compared to the baseline values ( p  < 0.001), while probiotics did not cause a greater significant reduction in leptin level, compared to the placebo group.
","['obese women with food addiction ', 'Participants ( n  = 62', 'obese women with FA']","['probiotics and restricted calorie diet', 'probiotic supplementation', 'placebo', 'Multi-probiotic supplementation', 'restricted calorie diet (RCD) plus either probiotic, or placebo']","['oxytocin increased and NPY', 'anthropometric indices, eating behavior, and hormone levels', 'eating behavior', 'leptin level', 'Anthropometric measurements, biochemical markers, eating behavior and appetite', 'reduced weight, body mass index (BMI), waist circumference (WC), waist to hip ratio (WHR), body fat percentage (BFP), and trunk fat percentage (TFP']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0027893', 'cui_str': 'Neuropeptide Y'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0474423', 'cui_str': 'Eating behavior and appetite'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",,0.594889,"Moreover, leptin level significantly decreased in the probiotic group compared to the baseline values ( p  < 0.001), while probiotics did not cause a greater significant reduction in leptin level, compared to the placebo group.
","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Narmaki', 'Affiliation': 'National Nutrition and Food Technology Research Institute, Department of Clinical Nutrition & Dietetics, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohaddeseh', 'Initials': 'M', 'LastName': 'Borazjani', 'Affiliation': 'School of Nutrition and Food Science, Shiraz University of Medical Science, Iran.'}, {'ForeName': 'Asal', 'Initials': 'A', 'LastName': 'Ataie-Jafari', 'Affiliation': 'Department of Nutrition, Science and Research Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Hariri', 'Affiliation': 'National Nutrition and Food Technology Research Institute, Department of Clinical Nutrition & Dietetics, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azita Hekmat', 'Initials': 'AH', 'LastName': 'Doost', 'Affiliation': 'National Nutrition and Food Technology Research Institute, Department of Clinical Nutrition & Dietetics, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Qorbani', 'Affiliation': 'Non-communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Atoosa', 'Initials': 'A', 'LastName': 'Saidpour', 'Affiliation': 'National Nutrition and Food Technology Research Institute, Department of Clinical Nutrition & Dietetics, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Nutritional neuroscience,['10.1080/1028415X.2020.1826763']
2800,33054695,"Effects of Breakfast Omission on Resting, Exercise, and Postexercise Autonomic and Hemodynamic Profile in Men.","Purpose : The acute effects of fasting interventions on metabolic dynamics have been widely investigated. However, knowledge about the acute effect of overnight fasting on hemodynamic and cardiac autonomic modulation is limited, especially during and after exercise. Our objective was to investigate the effects of breakfast omission on hemodynamic and cardiac autonomic modulation during different stress conditions.  Method : Twenty-one young men [age: 20.3 (20.1, 26.5 years); body mass index: 22.7 (21.4, 24.4 kg/m 2 )] underwent resting and postexercise blood pressure assessments and heart rate variability (HRV) analysis, using the SD1 and SD2 indices of Poincaré plots, at rest in supine and standing positions, every 10 minutes during moderate cardiorespiratory training and every 10 minutes throughout the postexercise recovery phase, for a total of 30 minutes for each phase (exercise and recovery). All measurements were performed in a randomized order after overnight fasting or 60 minutes after a breakfast containing ~20% of the total recommended daily calories. The normality hypothesis was rejected, and the Wilcoxon test was conducted to compare the interventions ( p  < .05).  Results : No differences between interventions were observed for resting and postexercise blood pressures ( p  = .21 to 0.87) or for resting, exercise, and postexercise SD1 ( p  = .10 to 0.82) and SD2 indices ( p  = .14 to 0.71).  Conclusions : We concluded that overnight fasting does not promote significant changes in resting and postexercise blood pressures or cardiac autonomic modulation in young men at rest (in supine and standing positions), during 30 minutes of moderate cardiorespiratory training and throughout a 30-minute postexercise recovery phase.",2020,"We concluded that overnight fasting does not promote significant changes in resting and postexercise blood pressures or cardiac autonomic modulation in young men at rest (in supine and standing positions), during 30 minutes of moderate cardiorespiratory training and throughout a 30-minute postexercise recovery phase.","['Men', 'Method : Twenty-one young men [age: 20.3 (20.1, 26.5\xa0years); body mass index: 22.7 (21.4, 24.4 kg/m 2 ']","['breakfast omission', 'Breakfast Omission', 'fasting interventions']","['hemodynamic and cardiac autonomic modulation', 'resting and postexercise blood pressures or cardiac autonomic modulation', 'SD2 indices', 'resting, exercise, and postexercise SD1', 'resting and postexercise blood pressures', 'Resting, Exercise, and Postexercise Autonomic and Hemodynamic Profile', 'postexercise blood pressure assessments and heart rate variability (HRV) analysis, using the SD1 and SD2 indices of Poincaré plots, at rest in supine and standing positions']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1861380', 'cui_str': 'Syndactyly, Type I'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}]",21.0,0.0321627,"We concluded that overnight fasting does not promote significant changes in resting and postexercise blood pressures or cardiac autonomic modulation in young men at rest (in supine and standing positions), during 30 minutes of moderate cardiorespiratory training and throughout a 30-minute postexercise recovery phase.","[{'ForeName': 'Enoque', 'Initials': 'E', 'LastName': 'Barbosa', 'Affiliation': 'Centro Universitário Euro Americano-UNIEURO.'}, {'ForeName': 'Raiane Maiara', 'Initials': 'RM', 'LastName': 'Dos Santos Pereira', 'Affiliation': 'Centro Universitário Euro Americano-UNIEURO.'}, {'ForeName': 'Weslayne Lima', 'Initials': 'WL', 'LastName': 'Guaraná', 'Affiliation': 'Centro Universitário Euro Americano-UNIEURO.'}, {'ForeName': 'Caio Gabriel de Jesus', 'Initials': 'CGJ', 'LastName': 'Rocha', 'Affiliation': 'Centro Universitário Euro Americano-UNIEURO.'}, {'ForeName': 'Pedro Henrique', 'Initials': 'PH', 'LastName': 'Fernandes', 'Affiliation': 'Centro Universitário Euro Americano-UNIEURO.'}, {'ForeName': 'Pedro Henrique Lobato', 'Initials': 'PHL', 'LastName': 'de Oliveira', 'Affiliation': 'Centro Universitário Euro Americano-UNIEURO.'}, {'ForeName': 'Guilherme E', 'Initials': 'GE', 'LastName': 'Molina', 'Affiliation': 'Universidade de Brasília.'}, {'ForeName': 'Carlos Janssen Gomes', 'Initials': 'CJG', 'LastName': 'da Cruz', 'Affiliation': 'Centro Universitário Euro Americano-UNIEURO.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1825603']
2801,33054724,Precision implementation of early ambulation in elderly patients undergoing off-pump coronary artery bypass graft surgery: a randomized-controlled clinical trial.,"BACKGROUND


Although early ambulation (EA) is associated with improved outcomes in post-operative patients, implementation of EA in elderly patients is still a challenge. In this study, we aimed to design and assess a precision early ambulation program for cardiac rehabilitation.
METHODS


We conducted a single-center, randomized and controlled clinical trial in elderly patients aged over 60 years after off-pump coronary artery bypass graft (OPCABG) surgery. Patients were randomly assigned to a precision early ambulation (PEA) group or a routine ambulation (Control) group. Age-predicted maximal heart rate (APMHR) and maximal oxygen uptake (VO 2max)  were used as a reference to formulate and monitor the PEA regimen. The primary end-point was the postoperative length of stay in hospital (PLOS). The secondary end-points included 90-day mortality, incidence of early discharge, laboratory tests, length of ICU stay, the incidence of multiple organ complications and post-traumatic stress disorder (PTSD). Ambulation outcomes were also recorded.
RESULTS


In total, 178 patients were enrolled (n = 89 per group). In the intent-to-treat analysis, PLOS in the PEA group was shorter than that in the Control group (9.04 ± 3.08 versus 10.09 ± 3.32 days, respectively. Mean difference 1.045 days; 95% confidence interval [CI] 0.098-1.992; P = 0.031 in the unadjusted model; mean difference 0.957 days; CI 0.007-1.907; P = 0.048 in adjusted model). The incidence of early discharge differed significantly between the PEA and control groups (41[46.1%] versus 24[27.0%] patients, respectively. Odds ratio [OR] 0.432; CI 0.231-0.809; P = 0.009 in unadjusted model; OR 0.466; CI 0.244-0.889, P = 0.02 in adjusted model). The time of first bowel movement, partial pressure O 2  and post-traumatic stress disorder score in the PEA group were better than those in the Control group. Participants walked much longer distances on day 3 in the PEA group than those in the Control group (76.12 ± 29.02 versus 56.80 ± 24.40 m, respectively, P < 0.001).
CONCLUSION


APMHR and VO 2max  are valuable for implementation of PEA according to an established security threshold. PEA after OPCAPG surgery is safe and reliable for elderly patients, not only reducing the hospital stay, but also improving their physiological and psychological symptoms.
TRIAL REGISTRATION


This study is a component of a protocol retrospectively registered: Application of ERAS in cardiovascular surgery.
TRIAL REGISTRATION NUMBER


ChiCTR1800018167 . Date of registration: 3rd September, 2018. URL of trial registry record: http://www.chictr.org.cn/index.aspx.",2020,Mean difference 1.045 days; 95% confidence interval [CI] 0.098-1.992; P = 0.031 in the unadjusted model; mean difference 0.957 days; CI 0.007-1.907; P = 0.048 in adjusted model).,"['178 patients were enrolled (n\u2009=\u200989 per group', 'elderly patients aged over 60\u2009years after off-pump coronary artery bypass graft (OPCABG) surgery', 'elderly patients undergoing off-pump coronary artery bypass graft surgery', 'elderly patients']","['ERAS', 'precision early ambulation (PEA) group or a routine ambulation (Control) group', 'OPCAPG surgery', 'http://www.chictr.org.cn/index.aspx', 'PEA']","['hospital stay', 'incidence of early discharge', 'Ambulation outcomes', 'time of first bowel movement, partial pressure O 2  and post-traumatic stress disorder score', 'postoperative length of stay in hospital (PLOS', '90-day mortality, incidence of early discharge, laboratory tests, length of ICU stay, the incidence of multiple organ complications and post-traumatic stress disorder (PTSD', 'maximal heart rate (APMHR) and maximal oxygen uptake (VO 2max']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0013457', 'cui_str': 'Ambulation, Early'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",178.0,0.229864,Mean difference 1.045 days; 95% confidence interval [CI] 0.098-1.992; P = 0.031 in the unadjusted model; mean difference 0.957 days; CI 0.007-1.907; P = 0.048 in adjusted model).,"[{'ForeName': 'Zhaomei', 'Initials': 'Z', 'LastName': 'Cui', 'Affiliation': 'Intensive Care Unit (ICU), Department of Cardiac Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, Shandong, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Gynecology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, Shandong, China.'}, {'ForeName': 'Chaonan', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Department of Biostatistics, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, 250012, Shandong, China.'}, {'ForeName': 'Yiou', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Toxicological and Functional Test, Centers for Disease Control and Prevention of Shandong, Jinan, 250014, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhuang', 'Affiliation': 'Intensive Care Unit (ICU), Department of Cardiac Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, Shandong, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Intensive Care Unit (ICU), Department of Cardiac Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, Shandong, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Intensive Care Unit (ICU), Department of Cardiac Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, Shandong, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'Intensive Care Unit (ICU), Department of Cardiac Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, Shandong, China. deepblue1229@163.com.'}]",BMC geriatrics,['10.1186/s12877-020-01823-1']
2802,33054794,"Evaluation of the efficacy of two doses of vitamin D supplementation on glycemic, lipidemic and oxidative stress biomarkers during pregnancy: a randomized clinical trial.","BACKGROUND


Vitamin D deficiency during pregnancy is common and is likely to be associated with metabolic complications in the mother. The aim of this study was to assess the efficacy of two doses of vitamin D supplementation during pregnancy on maternal and cord blood vitamin D status and metabolic and oxidative stress biomarkers.
METHODS


The eligible pregnant women (n = 84) invited to participate in the study and randomly allocated to one of the two supplementation groups (1000 IU/d vitamin D and 2000 IU/d). Biochemical assessments of mothers including serum concentrations of 25(OH)D, calcium, phosphate, iPTH, fasting serum sugar (FBS), insulin, triglyceride, total cholesterol, LDL-C, HDL-C, malondialdehyde (MDA) and total antioxidant capacity (TAC) were done at the beginning and 34 weeks of gestation. Cord blood serum concentrations of 25(OH)D, iPTH, MDA and TAC were assessed at delivery as well. To determine the effects of vitamin D supplementation on metabolic markers 1-factor repeated-measures analysis of variance (ANOVA) was used. Between groups comparisons was done by using Independent-samples Student's t-test or Mann-Whitney test. P < 0.05 was considered as significant.
RESULTS


Supplementation with 1000 IU/d and 2000 IU/d vitamin D resulted in significant changes in vitamin D status over pregnancy (24.01 ± 21.7, P < 0.001 in 1000 IU/d group and 46.7 ± 30.6 nmol/L, P < 0.001 in 2000 IU/d group). Daily intake of 2000 compared with 1000 IU/d tended to increase the serum concentration of HDL-C (10 ± 8.37, P < 0.001 in 1000 IU/d group and 9.52 ± 11.39 mg/dL, P < 0.001 in 2000 IU/d group). A significant decrement in serum concentration of iPTH observed in both groups (- 4.18 ± 7.5, P = 0.002 in 1000 IU/d group and - 8.36 ± 14.17, P = 0.002 in 2000 IU/d group).
CONCLUSIONS


Supplementation with 2000 IU/d vitamin D as compared with 1000 IU/d, is more effective in promoting vitamin D status and HDL-C serum concentration and in decreasing iPTH over pregnancy.
TRIAL REGISTRATION


This trial is registered at clinicaltrials.gov ( NCT03308487 ). Registered 12 October 2017 'retrospectively registered'.",2020,"A significant decrement in serum concentration of iPTH observed in both groups (- 4.18 ± 7.5, P = 0.002 in 1000 IU/d group and - 8.36 ± 14.17, P = 0.002 in 2000 IU/d group).
","['eligible pregnant women (n\u2009=\u200984) invited to participate in the study', 'pregnancy']","['vitamin D supplementation', 'vitamin D and 2000']","['glycemic, lipidemic and oxidative stress biomarkers', 'serum concentration of iPTH', 'Cord blood serum concentrations of 25(OH)D, iPTH, MDA and TAC', 'maternal and cord blood vitamin D status and metabolic and oxidative stress biomarkers', 'serum concentrations of 25(OH)D, calcium, phosphate, iPTH, fasting serum sugar (FBS), insulin, triglyceride, total cholesterol, LDL-C, HDL-C, malondialdehyde (MDA) and total antioxidant capacity (TAC', 'serum concentration of HDL-C', 'vitamin D status and HDL-C serum concentration', 'vitamin D status over pregnancy']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0470277', 'cui_str': '2000'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0047008', 'cui_str': ""3,4-O-isopropylidene-3,3',4,5'-tetrahydroxystilbene""}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",,0.53284,"A significant decrement in serum concentration of iPTH observed in both groups (- 4.18 ± 7.5, P = 0.002 in 1000 IU/d group and - 8.36 ± 14.17, P = 0.002 in 2000 IU/d group).
","[{'ForeName': 'Soudabe', 'Initials': 'S', 'LastName': 'Motamed', 'Affiliation': 'Department of Cellular and Molecular Nutrition, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Nikooyeh', 'Affiliation': 'Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Hafezi St., Farahzadi Blvd., Shahrak Qods (Gharb), Tehran, 1981619573, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kashanian', 'Affiliation': 'Department of Obstetrics & Gynecology, Akbarabadi Teaching Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Chamani', 'Affiliation': 'Department of Obstetrics & Gynecology, Akbarabadi Teaching Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Tirang R', 'Initials': 'TR', 'LastName': 'Neyestani', 'Affiliation': 'Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Hafezi St., Farahzadi Blvd., Shahrak Qods (Gharb), Tehran, 1981619573, Iran. t.neyestani@sbmu.ac.ir.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03311-1']
2803,33054811,Effectiveness of a home-based telerehabilitation system in patients after total hip arthroplasty: study protocol of a randomized controlled trial.,"BACKGROUND


The demand for total hip arthroplasty (THA) is quickly rising given the escalating global incidence of hip osteoarthritis, and it is widely accepted that the post-surgery rehabilitation is key to optimize outcomes. The overall objective of this study is to evaluate the effectiveness of a new telerehabilitation solution, ReHub, for the physical function and clinical outcome improvement following THA. The specific aims of this manuscript are to describe the study design, protocol, content of interventions, and primary and secondary outcomes and to discuss the clinical rehabilitation impact of the expected experimental results.
METHODS/DESIGN


This prospective, randomized, controlled, parallel-group trial will include 56 patients who had undergone primary THA. Patients are randomized to a control group (standard rehabilitation during the 2-week stay in the rehabilitation clinic followed by 3 weeks of unsupervised home-based rehabilitation) or an experimental group (standard rehabilitation during the 2-week stay in the rehabilitation clinic followed by 3 weeks of home-based ReHub-assisted telerehabilitation). The primary outcome is physical performance assessed through the Timed Up-and-Go (TUG) test. Secondary outcomes include independence level, pain intensity, hip disability, hip range of motion, muscle strength, and patient's perception of clinical improvement.
DISCUSSION


Proving the clinical and cost-effectiveness of a home-based telerehabilitation program for physical and muscle function following THA could support its systematic incorporation in post-surgical rehabilitation protocols, which should be tailored to the individual and collective needs.
TRIAL REGISTRATION


ClinicalTrial.gov NCT04176315 . Registered on 22 November 2019.",2020,"Proving the clinical and cost-effectiveness of a home-based telerehabilitation program for physical and muscle function following THA could support its systematic incorporation in post-surgical rehabilitation protocols, which should be tailored to the individual and collective needs.
","['patients after total hip arthroplasty', '56 patients who had undergone primary THA']","['home-based telerehabilitation program', 'total hip arthroplasty (THA', 'control group (standard rehabilitation during the 2-week stay in the rehabilitation clinic followed by 3\u2009weeks of unsupervised home-based rehabilitation) or an experimental group (standard rehabilitation during the 2-week stay in the rehabilitation clinic followed by 3\u2009weeks of home-based ReHub-assisted telerehabilitation', 'home-based telerehabilitation system']","[""independence level, pain intensity, hip disability, hip range of motion, muscle strength, and patient's perception of clinical improvement"", 'physical performance assessed through the Timed Up-and-Go (TUG) test']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",56.0,0.0694637,"Proving the clinical and cost-effectiveness of a home-based telerehabilitation program for physical and muscle function following THA could support its systematic incorporation in post-surgical rehabilitation protocols, which should be tailored to the individual and collective needs.
","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Busso', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Surgical Sciences, University of Turin, C.so Dogliotti 14, 10126, Turin, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Castorina', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Surgical Sciences, University of Turin, C.so Dogliotti 14, 10126, Turin, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Di Monaco', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Presidio Sanitario San Camillo, Fondazione Opera San Camillo, Turin, Italy.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rodriguez', 'Affiliation': 'DyCare - Bio-Sensing Solutions S.L., Barcelona, Spain.'}, {'ForeName': 'Hadis', 'Initials': 'H', 'LastName': 'Mahdavi', 'Affiliation': 'DyCare - Bio-Sensing Solutions S.L., Barcelona, Spain.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Balocco', 'Affiliation': 'Department of Mathematics and Informatics, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Trucco', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Presidio Sanitario San Camillo, Fondazione Opera San Camillo, Turin, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Conti', 'Affiliation': 'MediSport, Human Performance Lab - Como and Varese, Varese, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Castagna', 'Affiliation': 'IRCCS Humanitas Institute, Milan, Italy.'}, {'ForeName': 'Marco Alessandro', 'Initials': 'MA', 'LastName': 'Minetto', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Surgical Sciences, University of Turin, C.so Dogliotti 14, 10126, Turin, Italy. marco.minetto@unito.it.'}]",Trials,['10.1186/s13063-020-04791-4']
2804,33054825,Group intervention for siblings and parents of children with chronic disorders (SIBS-RCT): study protocol for a randomized controlled trial.,"BACKGROUND


Siblings and parents of children with neurodevelopmental disorders are at risk of mental health problems and poorer family communication. Some group interventions for siblings exist, but few have clearly described parent components and none are considered evidence-based.
METHODS


We are conducting a randomized controlled trial comparing a five-session manual-based group intervention for siblings (aged 8 to 16 years) and parents of children with neurodevelopmental disorders to a 12-week waitlist, called SIBS-RCT. The intervention comprises three separate sibling and parent group sessions and two joint sessions in which each sibling talks to their parent alone. The intervention aims at improving parent-child communication and covers themes such as siblings' understanding of the neurodevelopmental disorder, siblings' emotions, and perceived family challenges. Participants are recruited through municipal and specialist health centers across Norway. The primary outcome is sibling mental health. Quality of life and family communication are secondary outcomes. Participants are block-randomized to the intervention or 12-week waitlist in groups of six. Measures are collected electronically at pre- and post-intervention/waitlist, as well as 3, 6, and 12 months post-intervention. The main effect to be examined is the difference between the intervention and waitlist at 12 weeks post. All outcomes will also be examined using growth curve analyses. We plan to include 288 siblings and their parents by the end of 2022.
DISCUSSION


SIBS-RCT represents a major contribution to the research and practice field towards establishing an evidence-based intervention for siblings. In the event that intervention and waitlist are no different, the impact of SIBS-RCT is still substantial in that we will aim to identify participant subgroups that show positive response and effective components of the SIBS manual by examining group leader adherence as an outcome predictor. This will allow us to continue to re-engineer the SIBS manual iteratively to improve outcomes, and avoid the promotion of a less-than-optimal intervention.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04056884 . Registered in August 2019.",2020,The intervention comprises three separate sibling and parent group sessions and two joint sessions in which each sibling talks to their parent alone.,"['Participants are recruited through municipal and specialist health centers across Norway', '288 siblings and their parents by the end of 2022', 'siblings (aged 8 to 16\u2009years) and parents of children with neurodevelopmental disorders to a 12-week waitlist, called SIBS-RCT', 'Siblings and parents of children with neurodevelopmental disorders', 'siblings and parents of children with chronic disorders (SIBS-RCT']",['five-session manual-based group intervention'],"['sibling mental health', 'Quality of life and family communication']","[{'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1535926', 'cui_str': 'Neurodevelopmental disorder'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",,0.0802071,The intervention comprises three separate sibling and parent group sessions and two joint sessions in which each sibling talks to their parent alone.,"[{'ForeName': 'Krister W', 'Initials': 'KW', 'LastName': 'Fjermestad', 'Affiliation': 'Department of Psychology, University of Oslo, New Haven, Norway. kristefj@uio.no.'}, {'ForeName': 'Wendy K', 'Initials': 'WK', 'LastName': 'Silverman', 'Affiliation': 'Child Psychiatry, Child Study Center, New Haven, USA.'}, {'ForeName': 'Torun M', 'Initials': 'TM', 'LastName': 'Vatne', 'Affiliation': 'Department of Psychology, University of Oslo, New Haven, Norway.'}]",Trials,['10.1186/s13063-020-04781-6']
2805,33054828,Nocebo effects by providing informed consent in shared decision making? Not necessarily: a randomized pilot-trial using an open-label placebo approach.,"BACKGROUND


Thorough information of the patient is an integral part of the process of shared decision making. We aimed to investigate if detailed information about medication may induce nocebo (or placebo) effects.
METHODS


We conducted a randomized, single-blind, pilot-study including n = 51 psychiatric in-patients aged between 18 and 80 years with a depressive disorder and accompanying sleeping disorders. In the intervention group we provided thorough information about adverse effects, while the control group received only a simple consent procedure. In both groups, patients received an open-label placebo pill instead of their sleeping medication.
RESULTS


No statistically significant differences between the intervention group and the control group were found regarding the main outcome parameter (a visual analogue scale indicating impairment by the new pill).
CONCLUSION


In this study, we were not able detect an effect of informed consent vs. simple consent on the emergence of placebo or nocebo effects. This finding is contrary to most assumptions and publications about this topic.
TRIAL REGISTRATION


Trial registration number: DRKS00017653, registered August 30th 2018. Retrosprectively registered.",2020,"No statistically significant differences between the intervention group and the control group were found regarding the main outcome parameter (a visual analogue scale indicating impairment by the new pill).
",['n\xa0=\u200951 psychiatric in-patients aged between 18 and 80\u2009years with a depressive disorder and accompanying sleeping disorders'],"['nocebo (or placebo', 'placebo', 'open-label placebo approach', 'open-label placebo']",['visual analogue scale indicating impairment by the new pill'],"[{'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}]",,0.309487,"No statistically significant differences between the intervention group and the control group were found regarding the main outcome parameter (a visual analogue scale indicating impairment by the new pill).
","[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Holzhüter', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar, Technische Universität München, Möhlstraße 26, 81675, Munich, Germany. fabian.holzhueter@mri.tum.de.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Hamann', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar, Technische Universität München, Möhlstraße 26, 81675, Munich, Germany.'}]",BMC medical ethics,['10.1186/s12910-020-00541-y']
2806,33054836,The effect of life coaching on psychological distress among dental students: interventional study.,"BACKGROUND


Depression, stress, and anxiety are common psychological conditions among dental students in many countries around the world. A number of researchers have found life coaching to be effective at reducing psychological distress. The aim of this study was to assess the effect of a life coaching program on dental students' psychological status.
METHODS


A quasi-experiment study with two arms was conducted on 88 female dental students at Umm Al-Qura University (study group = 44; control group = 44). The psychological status was assessed by questionnaire before and after intervention. The questionnaire was composed of the Depression and Anxiety Stress Scale (DASS-21), Resilience Scale (RS-14), the Psychological Well-Being Scale-Short (PWB-S), and goal approach questions. The study group received a coaching program comprising one lecture for 1 h and five phone coaching sessions over 5 weeks, while the control group received no intervention.
RESULTS


The study group showed a significant reduction in depression, anxiety, stress, resilience, and self-acceptance according to the PWB-S scale. Also, goal approach was significantly improved. On the other hand, the control group showed a significant reduction on the RS-14 only. The differences in the tested scales between the study group and the control group from pre-intervention (T1) to post-intervention (T2) showed significant differences in depression, stress, self-acceptance, and goal approach measurements per t-test.
CONCLUSION


The study's findings showed that life coaching had the effect of reducing psychological distress, which encouraged the implementation of coaching practice in the daily life of dental students.",2020,"The study group showed a significant reduction in depression, anxiety, stress, resilience, and self-acceptance according to the PWB-S scale.","['88 female dental students at Umm Al-Qura University (study group\u2009=\u200944; control group\u2009=\u200944', 'dental students', ""dental students' psychological status""]","['life coaching program', 'coaching program comprising one lecture for 1\xa0h and five phone coaching sessions', 'control group received no intervention', 'life coaching']","['psychological distress', 'depression, anxiety, stress, resilience, and self-acceptance according to the PWB-S scale', 'depression, stress, self-acceptance, and goal approach measurements per t-test', 'Depression and Anxiety Stress Scale (DASS-21), Resilience Scale (RS-14), the Psychological Well-Being Scale-Short (PWB-S), and goal approach questions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}]",88.0,0.0221632,"The study group showed a significant reduction in depression, anxiety, stress, resilience, and self-acceptance according to the PWB-S scale.","[{'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Aboalshamat', 'Affiliation': 'Dental Public Health Division, Preventative Dentistry Department, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia. ktaboalshamat@uqu.edu.sa.'}, {'ForeName': 'Duha', 'Initials': 'D', 'LastName': 'Al-Zaidi', 'Affiliation': 'Dental Intern, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Duha', 'Initials': 'D', 'LastName': 'Jawa', 'Affiliation': 'Dental Intern, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Hanouf', 'Initials': 'H', 'LastName': 'Al-Harbi', 'Affiliation': 'Dental Intern, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Raghad', 'Initials': 'R', 'LastName': 'Alharbi', 'Affiliation': 'Dental Intern, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Shahad', 'Initials': 'S', 'LastName': 'Al-Otaibi', 'Affiliation': 'Dental Intern, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}]",BMC psychology,['10.1186/s40359-020-00475-5']
2807,32975869,"Isatuximab monotherapy in relapsed/refractory multiple myeloma: A Japanese, multicenter, phase 1/2, safety and efficacy study.","Isatuximab, an anti-CD38 monoclonal antibody, targets cells that strongly express CD38 including malignant plasma cells. This open-label, single-arm, multicenter, phase 1/2 trial investigated the tolerability/safety and efficacy of isatuximab monotherapy in Japanese patients with heavily pretreated, relapsed/refractory multiple myeloma (RRMM). In Phase 1, patients were sequentially assigned to receive isatuximab once weekly (QW) in cycle 1 (4 weeks) and every 2 weeks (Q2W) in subsequent cycles. Cohort 1 (n = 3) received 10 mg/kg QW/Q2W; cohort 2 (n = 5) received 20 mg/kg QW/Q2W. No dose-limiting toxicities occurred; the recommended dose for the single-arm phase 2 study (n = 28) was 20 mg/kg QW/Q2W. The overall safety profile was consistent with the current knowledge of isatuximab. The most common adverse events were infusion reactions (42.9%; 12/28); all were grade 1/2 and generally occurred during the first infusion. The overall response rate with 20 mg/kg QW/Q2W isatuximab was 36.4% (12/33); patients with high-risk cytogenetic abnormalities had comparable results. In phase 2, the median progression-free survival was 4.7 (95% confidence interval, 3.75 to not reached) months. Median overall survival was not reached. Isatuximab monotherapy was well tolerated and effective in patients with heavily pretreated RRMM including high-risk cytogenetic patients. This trial is registered at ClinicalTrials.gov as NCT02812706.",2020,The most common adverse events were infusion reactions (42.9%; 12/28); all were grade 1/2 and generally occurred during the first infusion.,"['patients with heavily pretreated RRMM including high-risk cytogenetic patients', 'relapsed/refractory multiple myeloma', 'Japanese patients with heavily pretreated, relapsed/refractory multiple myeloma (RRMM']","['isatuximab monotherapy', '20\xa0mg/kg QW/Q2W', 'Isatuximab monotherapy', '10\xa0mg/kg QW/Q2W']","['tolerability/safety and efficacy', 'overall response rate', 'median progression-free survival', 'overall safety profile', 'Median overall survival', 'tolerated and effective']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetics'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C4330502', 'cui_str': 'isatuximab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.068648,The most common adverse events were infusion reactions (42.9%; 12/28); all were grade 1/2 and generally occurred during the first infusion.,"[{'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Sunami', 'Affiliation': 'Department of Hematology, National Hospital Organization, Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Myeloma/Amyloidosis Center, Japanese Red Cross Medical Center, Tokyo, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Ri', 'Affiliation': 'Department of Hematology and Oncology, Nagoya City University Institute of Medical and Pharmaceutical Sciences, Nagoya, Japan.'}, {'ForeName': 'Morio', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Hematology, National Hospital Organization Shibukawa Medical Center, Shibukawa, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Shimazaki', 'Affiliation': 'Department of Hematology, Japan Community Health care Organization Kyoto Kuramaguchi Medical Center, Kyoto, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Asaoku', 'Affiliation': 'Department of Hematology, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Shibayama', 'Affiliation': 'Department of Hematology and Oncology, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Ishizawa', 'Affiliation': 'Department of Third Internal Medicine, Division of Hematology and Cell Therapy, Yamagata University Faculty of Medicine, Yamagata, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Takamatsu', 'Affiliation': 'Department of Hematology, Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ikeda', 'Affiliation': 'Division of Hematology and Stem Cell Transplantation, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Maruyama', 'Affiliation': 'Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Kaneko', 'Affiliation': 'Department of Hematology, Japanese Red Cross Osaka Hospital, Osaka, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Hematology, Japanese Red Cross Society Suwa Hospital, Suwa, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Kiguchi', 'Affiliation': 'Department of Hematology, Chugoku Central Hospital, Fukuyama, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Iyama', 'Affiliation': 'Department of Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Murakami', 'Affiliation': 'Department of Laboratory Sciences, Gunma University Graduate School of Health Sciences, Maebashi, Japan.'}, {'ForeName': 'Keishiro', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Research and Development, Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Tada', 'Affiliation': 'Research and Development, Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Macé', 'Affiliation': 'Research and Development, Sanofi, Vitry, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Guillemin-Paveau', 'Affiliation': 'Research and Development, Sanofi, Vitry, France.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Department of Hematology and Oncology, Nagoya City University Institute of Medical and Pharmaceutical Sciences, Nagoya, Japan.'}]",Cancer science,['10.1111/cas.14657']
2808,31743110,BCG revaccination boosts adaptive polyfunctional Th1/Th17 and innate effectors in IGRA+ and IGRA- Indian adults.,"BACKGROUNDBacille Calmette-Guérin (BCG) vaccine is protective against Tuberculosis (TB) in children, but its efficacy wanes with age. Consequently, determining if BCG revaccination augments anti-TB immunity in young adults in TB endemic regions is vital.METHODSTwo hundred healthy adults, BCG vaccinated at birth, were tested for their IFN-γ release assay (IGRA) status. Of these, 28 IGRA+ and 30 IGRA- were BCG revaccinated, and 24 IGRA+ and 23 IGRA- subjects served as unvaccinated controls. T and innate cell responses to mycobacterial antigens were analyzed by 14-color flow cytometry over 34 weeks.RESULTSIFN-γ and/or IL-2 Ag85A- and BCG-specific CD4+ and CD8+ T cell responses were boosted by revacciantion at 4 and 34 weeks, respectively, and were > 2-fold higher in IGRA+ compared with IGRA- vaccinees. Polyfunctional Ag85A, BCG, and mycobacterium tuberculosis (Mtb) latency Ag-specific (LTAg-specific) CD4+ T cells expressing up to 8 cytokines were also significantly enhanced in both IGRA+ and IGRA- vaccinees relative to unvaccinated controls, most markedly in IGRA+ vaccinees. A focused analysis of Th17 responses revealed expansion of Ag85A-, BCG-, and LTAg-specific total IL-17A+,IL-17F+,IL-22+, and IL-10+ CD4+ T cell effectors in both IGRA+ and IGRA- subjects. Also, innate IFN-γ+ NK/γδ/NKT cell responses were higher in both IGRA+ and IGRA- vaccinees compared with controls. This is the first evidence to our knowledge that BCG revaccination significantly boosts antimycobacterial Th1/Th17 responses in IGRA+ and IGRA- subjects.CONCLUSIONThese data show that BCG revaccination is immunogenic in IGRA- and IGRA+ subjects, implying that Mtb preinfection in IGRA+ subjects does not impact immunogenicity. This has implications for public health and vaccine development strategies.FUNDINGThis work was funded principally by DBT-NIH (BT/MB/Indo-US/HIPC/2013).",2019,"Ag85A- and BCG-specific CD4+ and CD8+ T cell responses were boosted by revacciantion at 4 and 34 weeks, respectively, and were > 2-fold higher in IGRA+ compared with IGRA- vaccinees.","['hundred healthy adults, BCG vaccinated at birth, were tested for their IFN-γ release assay (IGRA) status', 'IGRA+ and IGRA- Indian adults']","['RESULTSIFN-γ and/or IL-2', 'Calmette-Guérin (BCG) vaccine', 'BCG revaccination']","['expansion of Ag85A-, BCG-, and LTAg-specific total IL-17A+,IL-17F+,IL-22+, and IL-10+ CD4+ T cell effectors', 'Mtb) latency Ag-specific (LTAg-specific) CD4+ T cells expressing up to 8 cytokines', 'Polyfunctional Ag85A, BCG, and mycobacterium tuberculosis', 'innate IFN-γ+ NK/γδ/NKT cell responses', 'Ag85A- and BCG-specific CD4+ and CD8+ T cell responses']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C3178802', 'cui_str': 'Interferon gamma release assay'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C2713304', 'cui_str': 'Revaccination'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0026926', 'cui_str': 'Mycobacterium tuberculosis'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}]",0.0,0.0331071,"Ag85A- and BCG-specific CD4+ and CD8+ T cell responses were boosted by revacciantion at 4 and 34 weeks, respectively, and were > 2-fold higher in IGRA+ compared with IGRA- vaccinees.","[{'ForeName': 'Srabanti', 'Initials': 'S', 'LastName': 'Rakshit', 'Affiliation': 'Laboratory of Immunology of HIV-TB Co-infection, Centre for Infectious Disease Research, Indian Institute of Science, Bangalore, India.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Laboratory of Immunology of HIV-TB Co-infection, Centre for Infectious Disease Research, Indian Institute of Science, Bangalore, India.'}, {'ForeName': 'Vasista', 'Initials': 'V', 'LastName': 'Adiga', 'Affiliation': 'Laboratory of Immunology of HIV-TB Co-infection, Centre for Infectious Disease Research, Indian Institute of Science, Bangalore, India.'}, {'ForeName': 'Bharath K', 'Initials': 'BK', 'LastName': 'Sundararaj', 'Affiliation': 'Laboratory of Immunology of HIV-TB Co-infection, Centre for Infectious Disease Research, Indian Institute of Science, Bangalore, India.'}, {'ForeName': 'Pravat Nalini', 'Initials': 'PN', 'LastName': 'Sahoo', 'Affiliation': 'Laboratory of Immunology of HIV-TB Co-infection, Centre for Infectious Disease Research, Indian Institute of Science, Bangalore, India.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kenneth', 'Affiliation': 'Department of Infectious Diseases and.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': ""D'Souza"", 'Affiliation': 'Department of Infectious Diseases and.'}, {'ForeName': 'Wesley', 'Initials': 'W', 'LastName': 'Bonam', 'Affiliation': 'Arogyavaram Medical Centre, Madanapalle, India.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'Arogyavaram Medical Centre, Madanapalle, India.'}, {'ForeName': 'Kees Lmc', 'Initials': 'KL', 'LastName': 'Franken', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Tom Hm', 'Initials': 'TH', 'LastName': 'Ottenhoff', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Finak', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Gottardo', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Kenneth D', 'Initials': 'KD', 'LastName': 'Stuart', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'De Rosa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Annapurna', 'Initials': 'A', 'LastName': 'Vyakarnam', 'Affiliation': 'Laboratory of Immunology of HIV-TB Co-infection, Centre for Infectious Disease Research, Indian Institute of Science, Bangalore, India.'}]",JCI insight,['10.1172/jci.insight.130540']
2809,31852846,Immunomodulatory activity of humanized anti-IL-7R monoclonal antibody RN168 in subjects with type 1 diabetes.,"BACKGROUND


The cytokine IL-7 is critical for T cell development and function. We performed a Phase Ib study in patients with type 1 diabetes (T1D) to evaluate how blockade of IL-7 would affect immune cells and relevant clinical responses.
METHODS


Thirty-seven subjects with T1D received s.c. RN168, a monoclonal antibody that blocks the IL -7 receptor α (IL7Rα) in a dose-escalating study.
RESULTS


Between 90% and 100% IL-7R occupancy and near-complete inhibition of pSTAT5 was observed at doses of RN168 1 mg/kg every other week (Q2wk) and greater. There was a significant decline in CD4+ and CD8+ effector and central memory T cells and CD4+ naive cells, but there were fewer effects on CD8+ naive T cells. The ratios of Tregs to CD4+ or CD8+ effector and central memory T cells versus baseline were increased. RNA sequencing analysis showed downmodulation of genes associated with activation, survival, and differentiation of T cells. Expression of the antiapoptotic protein Bcl-2 was reduced. The majority of treatment-emergent adverse events (TEAEs) were mild and not treatment related. Four subjects became anti-EBV IgG+ after RN168, and 2 had symptoms of active infection. The immunologic response to tetanus toxoid was preserved at doses of 1 and 3 mg/kg Q2wk but reduced at higher doses.
CONCLUSIONS


This trial shows that, at dosages of 1-3 mg/kg, RN168 selectively inhibits the survival and activity of memory T cells while preserving naive T cells and Tregs. These immunologic effects may serve to eliminate pathologic T cells in autoimmune diseases.
TRIAL REGISTRATION


NCT02038764.
FUNDING


Pfizer Inc.",2019,"The immunologic response to tetanus toxoid was preserved at doses of 1 and 3 mg/kg Q2wk but reduced at higher doses.
","['subjects with type 1 diabetes', 'Thirty-seven subjects with T1D received s.c', 'patients with type 1 diabetes (T1D']","['IL-7R', 'humanized anti-IL-7R monoclonal antibody RN168']","['survival and activity of memory T cells', 'CD8+ naive T cells', 'activation, survival, and differentiation of T cells', 'ratios of Tregs to CD4+ or CD8+ effector and central memory T cells', 'immunologic response to tetanus toxoid', 'symptoms of active infection', 'CD4+ and CD8+ effector and central memory T cells and CD4+ naive cells']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",37.0,0.190929,"The immunologic response to tetanus toxoid was preserved at doses of 1 and 3 mg/kg Q2wk but reduced at higher doses.
","[{'ForeName': 'Kevan C', 'Initials': 'KC', 'LastName': 'Herold', 'Affiliation': 'Department of Immunobiology and.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Bucktrout', 'Affiliation': 'Rinat, Pfizer Inc., South San Francisco, California, USA.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Rinat, Pfizer Inc., South San Francisco, California, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Bode', 'Affiliation': 'Atlanta Diabetes Associates Research, Atlanta, Georgia, USA.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Gitelman', 'Affiliation': 'Department of Pediatrics and.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Hughes', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipid Research, John T. Milliken Department of Internal Medicine, Washington University School of Medicine in Saint Louis, Saint Louis, Missouri, USA.'}, {'ForeName': 'Tenshang', 'Initials': 'T', 'LastName': 'Joh', 'Affiliation': 'Worldwide R&D, Pfizer Inc., San Diego, California, USA.'}, {'ForeName': 'Janet B', 'Initials': 'JB', 'LastName': 'McGill', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipid Research, John T. Milliken Department of Internal Medicine, Washington University School of Medicine in Saint Louis, Saint Louis, Missouri, USA.'}, {'ForeName': 'Jeremy H', 'Initials': 'JH', 'LastName': 'Pettus', 'Affiliation': 'Department of Medicine, VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Potluri', 'Affiliation': 'Rinat, Pfizer Inc., South San Francisco, California, USA.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Schatz', 'Affiliation': 'Department of Pediatrics, College of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Shannon', 'Affiliation': 'Worldwide R&D, Pfizer Inc., San Diego, California, USA.'}, {'ForeName': 'Chandrasekhar', 'Initials': 'C', 'LastName': 'Udata', 'Affiliation': 'Worldwide R&D, Pfizer Inc., San Diego, California, USA.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Wong', 'Affiliation': 'Rinat, Pfizer Inc., South San Francisco, California, USA.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Levisetti', 'Affiliation': 'Rinat, Pfizer Inc., South San Francisco, California, USA.'}, {'ForeName': 'Bishu J', 'Initials': 'BJ', 'LastName': 'Ganguly', 'Affiliation': 'Rinat, Pfizer Inc., South San Francisco, California, USA.'}, {'ForeName': 'Pamela D', 'Initials': 'PD', 'LastName': 'Garzone', 'Affiliation': 'Rinat, Pfizer Inc., South San Francisco, California, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JCI insight,['10.1172/jci.insight.126054']
2810,33057132,Safety review of hydroxyprogesterone caproate in women with a history of spontaneous preterm birth.,"17-alpha-hydroxyprogesterone caproate (17P) has been in use for prevention of recurrent preterm birth since 2003 when the Meis trial was published. A requirement for Food and Drug Administration approval of 17P was a confirmatory trial, called ""PROLONG"", which was recently completed, but did not replicate the efficacy demonstrated in the Meis trial. This review analyzes the safety data from each trial, as well as integrated data from the two trials. The relative risks (95% CI) with 17P versus placebo in the integrated dataset were 0.66 (0.25-1.78) for miscarriage, 1.83 (0.68-4.91) for stillbirth, and 0.86 (0.53-1.41) for all fetal and neonatal death. The rate of gestational diabetes in the integrated dataset was 3.6% for 17P vs. 3.8% for placebo. Similar findings with low and comparable rates between 17P and placebo were also found for other adverse events. The integrated safety data demonstrate a favorable safety profile that was comparable to placebo.",2020,"The relative risks (95% CI) with 17P versus placebo in the integrated dataset were 0.66 (0.25-1.78) for miscarriage, 1.83 (0.68-4.91) for stillbirth, and 0.86 (0.53-1.41) for all fetal and neonatal death.",['women with a history of spontaneous preterm birth'],"['17-alpha-hydroxyprogesterone caproate (17P', 'hydroxyprogesterone caproate', 'placebo']","['rate of gestational diabetes', 'relative risks']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]","[{'cui': 'C0044971', 'cui_str': 'Hydroxyprogesterone caproate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}]",,0.407412,"The relative risks (95% CI) with 17P versus placebo in the integrated dataset were 0.66 (0.25-1.78) for miscarriage, 1.83 (0.68-4.91) for stillbirth, and 0.86 (0.53-1.41) for all fetal and neonatal death.","[{'ForeName': 'Baha', 'Initials': 'B', 'LastName': 'Sibai', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School-UTHealth, 6431 Fannin, Houston, TX, 77030, USA. baha.m.sibai@uth.tmc.edu.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Medical Branch, University of Texas, Galveston, TX, USA.'}, {'ForeName': 'Anita F', 'Initials': 'AF', 'LastName': 'Das', 'Affiliation': 'Das Consulting, Guerneville, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Gudeman', 'Affiliation': 'AMAG Pharmaceuticals, Inc., Boston, MA, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-00849-y']
2811,33057184,Cluster-randomized controlled trial for the early promotion of clinic visits for untreated hypertension.,"Despite clear evidence of the benefits of lowering blood pressure among patients with hypertension, the treatment rate remains <40% worldwide. In the present trial, we aimed to investigate the effects of the early promotion of clinic visits among patients with untreated hypertension detected during annual health checkups. This was a worksite-based, parallel group, cluster-randomized trial with blinded outcome assessment. Employees of 152 Japanese supermarket stores found to have untreated hypertension (blood pressure levels ≥ 160/100 mmHg) during health checkups were assigned to an early promotion group (encouraged to visit a clinic in face-to-face interviews and provided with a referral letter to a physician as well as a leaflet) or a control group (received usual care), according to random assignment. The primary outcome was the completion of a clinic visit within 6 months. Odds ratios with 95% confidence intervals for the early promotion group versus the control group were estimated using multilevel logistic regression with random effects of clusters. A total of 273 participants (mean age 50.3 years, 55% women) from 107 stores were assigned to the early promotion group (138 from 55 stores) or control group (135 from 52 stores). During the 6-month follow-up, 47 (34.1%) participants in the early promotion group visited a clinic, as did 26 (19.3%) in the control group (odds ratio 2.33, 95% confidence interval 1.12-4.84, P = 0.024). Early promotion using a referral letter during health checkups significantly increased the number of clinic visits within 6 months completed by participants with untreated hypertension (UMIN000025411).",2020,Early promotion using a referral letter during health checkups significantly increased the number of clinic visits within 6 months completed by participants with untreated hypertension (UMIN000025411).,"['untreated hypertension', '273 participants (mean age 50.3 years, 55% women) from 107 stores were assigned to the early promotion group (138 from 55 stores) or control group (135 from 52 stores', 'Employees of 152 Japanese supermarket stores found to have untreated hypertension (blood pressure levels ≥\u2009160/100\u2009mmHg) during health checkups', 'patients with untreated hypertension detected during annual health checkups', 'patients with hypertension']",['early promotion group (encouraged to visit a clinic in face-to-face interviews and provided with a referral letter to a physician as well as a leaflet) or a control group (received usual care'],"['completion of a clinic visit within 6 months', 'number of clinic visits', 'Odds ratios']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0260860', 'cui_str': 'General medical examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0332181', 'cui_str': 'Annual'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",273.0,0.110321,Early promotion using a referral letter during health checkups significantly increased the number of clinic visits within 6 months completed by participants with untreated hypertension (UMIN000025411).,"[{'ForeName': 'Azusa', 'Initials': 'A', 'LastName': 'Shima', 'Affiliation': 'Department of Clinical Nursing, Shiga University of Medical Science, Shiga, Japan. shiazusa@belle.shiga-med.ac.jp.'}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'Department of Preventive Medicine and Public Health, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Katsuyuki', 'Initials': 'K', 'LastName': 'Miura', 'Affiliation': 'Department of Public Health, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Yukako', 'Initials': 'Y', 'LastName': 'Tatsumi', 'Affiliation': 'Department of Clinical Nursing, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Ohkubo', 'Affiliation': 'Department of Hygiene and Public Health, Teikyo University, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Kawatsu', 'Affiliation': 'Occupational Health Care Office, Heiwado Co., Ltd, Shiga, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Morino', 'Affiliation': 'Department of Clinical Nursing, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'General Incorporated Foundation Kinki Health Administration Center, Shiga, Japan.'}, {'ForeName': 'Kayo', 'Initials': 'K', 'LastName': 'Godai', 'Affiliation': 'Department of Clinical Nursing, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Saori', 'Initials': 'S', 'LastName': 'Azuma', 'Affiliation': 'Department of Clinical Nursing, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Miyamatsu', 'Affiliation': 'Department of Clinical Nursing, Shiga University of Medical Science, Shiga, Japan.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-020-00559-0']
2812,33057670,Symptom Remission and Brain Cortical Networks at First Clinical Presentation of Psychosis: The OPTiMiSE Study.,"Individuals with psychoses have brain alterations, particularly in frontal and temporal cortices, that may be particularly prominent, already at illness onset, in those more likely to have poorer symptom remission following treatment with the first antipsychotic. The identification of strong neuroanatomical markers of symptom remission could thus facilitate stratification and individualized treatment of patients with schizophrenia. We used magnetic resonance imaging at baseline to examine brain regional and network correlates of subsequent symptomatic remission in 167 medication-naïve or minimally treated patients with first-episode schizophrenia, schizophreniform disorder, or schizoaffective disorder entering a three-phase trial, at seven sites. Patients in remission at the end of each phase were randomized to treatment as usual, with or without an adjunctive psycho-social intervention for medication adherence. The final follow-up visit was at 74 weeks. A total of 108 patients (70%) were in remission at Week 4, 85 (55%) at Week 22, and 97 (63%) at Week 74. We found no baseline regional differences in volumes, cortical thickness, surface area, or local gyrification between patients who did or did not achieved remission at any time point. However, patients not in remission at Week 74, at baseline showed reduced structural connectivity across frontal, anterior cingulate, and insular cortices. A similar pattern was evident in patients not in remission at Week 4 and Week 22, although not significantly. Lack of symptom remission in first-episode psychosis is not associated with regional brain alterations at illness onset. Instead, when the illness becomes a stable entity, its association with the altered organization of cortical gyrification becomes more defined.",2020,"We found no baseline regional differences in volumes, cortical thickness, surface area, or local gyrification between patients who did or did not achieved remission at any time point.","['patients with schizophrenia', 'Psychosis', '167 medication-naïve or minimally treated patients with first-episode schizophrenia, schizophreniform disorder, or schizoaffective disorder entering a three-phase trial, at seven sites']","['adjunctive psycho-social intervention', 'magnetic resonance imaging']","['structural connectivity across frontal, anterior cingulate, and insular cortices', 'Symptom Remission and Brain Cortical Networks', 'volumes, cortical thickness, surface area, or local gyrification']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0036358', 'cui_str': 'Schizophreniform disorder'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205276', 'cui_str': 'Local'}]",108.0,0.0479518,"We found no baseline regional differences in volumes, cortical thickness, surface area, or local gyrification between patients who did or did not achieved remission at any time point.","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Dazzan', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Lawrence', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Antje A T S', 'Initials': 'AATS', 'LastName': 'Reinders', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Egerton', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre at South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Neeltje E M', 'Initials': 'NEM', 'LastName': 'van Haren', 'Affiliation': ""Department of Child and Adolescent Psychiatry/Psychology, Erasmus Medical Centre, Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Merritt', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre at South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Barker', 'Affiliation': ""Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Perez-Iglesias', 'Affiliation': 'Early Intervention in Psychosis Service, Department of Psychiatry, Hospital Universitario Marques de Valdecilla, Santander, Spain.'}, {'ForeName': 'Kyra-Verena', 'Initials': 'KV', 'LastName': 'Sendt', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre at South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Arsime', 'Initials': 'A', 'LastName': 'Demjaha', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre at South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Kie W', 'Initials': 'KW', 'LastName': 'Nam', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre at South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Iris E', 'Initials': 'IE', 'LastName': 'Sommer', 'Affiliation': 'Department of Biomedical Sciences of Cells and Systems, Rijksuniversiteit Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Pantelis', 'Affiliation': 'Melbourne Neuropsychiatry Centre, Department of Psychiatry, The University of Melbourne and Melbourne Health, Carlton South, Victoria, Australia.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wolfgang Fleischhacker', 'Affiliation': 'Medical University of Innsbruck, Department of Psychiatry, Psychotherapy and Psychosomatics, Division of Psychiatry I, Innsbruck, Austria.'}, {'ForeName': 'Inge Winter', 'Initials': 'IW', 'LastName': 'van Rossum', 'Affiliation': ""Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Galderisi', 'Affiliation': 'Department of Psychiatry, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Armida', 'Initials': 'A', 'LastName': 'Mucci', 'Affiliation': 'Department of Psychiatry, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Drake', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Shon', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weiser', 'Affiliation': 'Department of Psychiatry, Sheba Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Covadonga M', 'Initials': 'CM', 'LastName': 'Martinez Diaz-Caneja', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañon, IiSGM, CIBERSAM, School of Medicine, Universidad Complutense Madrid, Madrid, Spain.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Janssen', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañon, IiSGM, CIBERSAM, School of Medicine, Universidad Complutense Madrid, Madrid, Spain.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Diaz-Marsa', 'Affiliation': 'Department of Psychiatry, Instituto de Investigación Sanitaria Hospital Clínico San Carlos; CIBERSAM; Universidad Complutense Madrid, Madrid, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Rodríguez-Jimenez', 'Affiliation': 'Department of Psychiatry, Instituto de Investigación Sanitaria Hospital 12 de Octubre (imas12); CIBERSAM; Universidad Complutense Madrid, Madrid, Spain.'}, {'ForeName': 'Celso', 'Initials': 'C', 'LastName': 'Arango', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañon, IiSGM, CIBERSAM, School of Medicine, Universidad Complutense Madrid, Madrid, Spain.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Baandrup', 'Affiliation': 'Center for Neuropsychiatric Schizophrenia Research, CNSR, and Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, Mental Health Centre Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Broberg', 'Affiliation': 'Center for Neuropsychiatric Schizophrenia Research, CNSR, and Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, Mental Health Centre Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Egill', 'Initials': 'E', 'LastName': 'Rostrup', 'Affiliation': 'Center for Neuropsychiatric Schizophrenia Research, CNSR, and Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, Mental Health Centre Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bjørn H', 'Initials': 'BH', 'LastName': 'Ebdrup', 'Affiliation': 'Center for Neuropsychiatric Schizophrenia Research, CNSR, and Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, Mental Health Centre Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Birte', 'Initials': 'B', 'LastName': 'Glenthøj', 'Affiliation': 'Center for Neuropsychiatric Schizophrenia Research, CNSR, and Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, Mental Health Centre Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rene S', 'Initials': 'RS', 'LastName': 'Kahn', 'Affiliation': 'Department of Psychiatry, University Medical Center Utrecht Brain Center, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McGuire', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre at South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Schizophrenia bulletin,['10.1093/schbul/sbaa115']
2813,33057675,Pediatric Optic Neuritis-Building Foundations for a Randomized Clinical Trial.,,2020,,[],[],[],[],[],[],,0.158866,,"[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Milea', 'Affiliation': 'Singapore National Eye Centre, Singapore.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.4250']
2814,33057694,Effects of an Internet-Based Cognitive Behavioral Therapy for Insomnia Program on Work Productivity: A Secondary Analysis.,"BACKGROUND


Cognitive-behavioral therapy for insomnia (CBT-I) may improve productivity along with insomnia symptoms, but the long-term duration of productivity gains is unknown.
PURPOSE


In this secondary analysis, effects of Internet-delivered CBT-I on work-related and daily activity productivity were examined through 1 year post-treatment.
METHODS


Adults with chronic insomnia (N = 303) were randomized to Internet-delivered CBT-I (Sleep Healthy Using the Internet [SHUTi]) or to patient education (PE). Participants reported interference with attendance (absenteeism) and productivity (presenteeism) at paid employment and in daily activities outside work on the Work Productivity Activity Impairment scale at baseline, 9 weeks later for postintervention assessment (post-assessment), and 6- and 12-month follow-ups.
RESULTS


Participants randomized to SHUTi were about 50% less likely than those in the PE condition to report any absenteeism (logistic regression odds ratio [OR] = 0.48 [95% confidence intervals {CI} = 0.24,0.96]), total impairment (OR = 0.52 [95% CI = 0.29,0.93]), or activity impairment (OR = 0.50 [95% CI = 0.30,0.85]) at post-assessment; however, differences were not detected at 6- or 12-month follow-ups. SHUTi participants also reported lower overall levels of presenteeism (constrained longitudinal data analysis MDiff = -6.84 [95% CI = -11.53, -2.15]), total impairment (MDiff = -7.62 [95% CI = -12.50, -2.73]), and activity impairment (MDiff = -7.47 [95% CI = -12.68, -2.26]) at post-assessment relative to PE participants. Differences were sustained at 6-month follow-up for presenteeism (MDiff = -5.02 [95% CI = -9.94, -0.10]) and total impairment (MDiff = -5.78 [95% CI = -10.91, -0.65]). No differences were detected by 12-month follow-up.
CONCLUSIONS


Findings suggest that Internet-based CBT-I may help accelerate improvement in work-related and daily activity impairment corroborating prior research, but did not find that CBT-I has persistent, long-term benefits in productivity relative to basic insomnia education.
TRIAL REGISTRATION


NCT00328250 ""Effectiveness of Internet Cognitive Behavioral Therapy Intervention for Treating Insomnia"" (https://clinicaltrials.gov/ct2/show/NCT00328250).",2020,"In this secondary analysis, effects of Internet-delivered CBT-I on work-related and daily activity productivity were examined through 1 year post-treatment.
",['Adults with chronic insomnia (N = 303'],"['Internet [SHUTi]) or to patient education (PE', 'Internet Cognitive Behavioral Therapy Intervention', 'Internet-Based Cognitive Behavioral Therapy', 'Internet-delivered CBT-I (Sleep Healthy', 'Cognitive-behavioral therapy']","['daily activity productivity', 'total impairment', 'overall levels of presenteeism', 'Work Productivity', 'interference with attendance (absenteeism) and productivity (presenteeism) at paid employment and in daily activities outside work on the Work Productivity Activity Impairment scale', 'activity impairment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1320371', 'cui_str': 'In paid employment'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",303.0,0.147826,"In this secondary analysis, effects of Internet-delivered CBT-I on work-related and daily activity productivity were examined through 1 year post-treatment.
","[{'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Shaffer', 'Affiliation': 'Center for Behavioral Health and Technology, University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Health Services and Systems Research Program, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Camacho', 'Affiliation': 'Center for Behavioral Health and Technology, University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'Karen S', 'Initials': 'KS', 'LastName': 'Ingersoll', 'Affiliation': 'Center for Behavioral Health and Technology, University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Thorndike', 'Affiliation': 'Pear Therapeutics, Inc., Boston, MA, USA.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Ritterband', 'Affiliation': 'Center for Behavioral Health and Technology, University of Virginia School of Medicine, Charlottesville, VA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa085']
2815,33057696,Effect of Integrating Machine Learning Mortality Estimates With Behavioral Nudges to Clinicians on Serious Illness Conversations Among Patients With Cancer: A Stepped-Wedge Cluster Randomized Clinical Trial.,"Importance


Serious illness conversations (SICs) are structured conversations between clinicians and patients about prognosis, treatment goals, and end-of-life preferences. Interventions that increase the rate of SICs between oncology clinicians and patients may improve goal-concordant care and patient outcomes.
Objective


To determine the effect of a clinician-directed intervention integrating machine learning mortality predictions with behavioral nudges on motivating clinician-patient SICs.
Design, Setting, and Participants


This stepped-wedge cluster randomized clinical trial was conducted across 20 weeks (from June 17 to November 1, 2019) at 9 medical oncology clinics (8 subspecialty oncology and 1 general oncology clinics) within a large academic health system in Pennsylvania. Clinicians at the 2 smallest subspecialty clinics were grouped together, resulting in 8 clinic groups randomly assigned to the 4 intervention wedge periods. Included participants in the intention-to-treat analyses were 78 oncology clinicians who received SIC training and their patients (N = 14 607) who had an outpatient oncology encounter during the study period.
Interventions


(1) Weekly emails to oncology clinicians with SIC performance feedback and peer comparisons; (2) a list of up to 6 high-risk patients (≥10% predicted risk of 180-day mortality) scheduled for the next week, estimated using a validated machine learning algorithm; and (3) opt-out text message prompts to clinicians on the patient's appointment day to consider an SIC. Clinicians in the control group received usual care consisting of weekly emails with cumulative SIC performance.
Main Outcomes and Measures


Percentage of patient encounters with an SIC in the intervention group vs the usual care (control) group.
Results


The sample consisted of 78 clinicians and 14 607 patients. The mean (SD) age of patients was 61.9 (14.2) years, 53.7% were female, and 70.4% were White. For all encounters, SICs were conducted among 1.3% in the control group and 4.6% in the intervention group, a significant difference (adjusted difference in percentage points, 3.3; 95% CI, 2.3-4.5; P < .001). Among 4124 high-risk patient encounters, SICs were conducted among 3.6% in the control group and 15.2% in the intervention group, a significant difference (adjusted difference in percentage points, 11.6; 95% CI, 8.2-12.5; P < .001).
Conclusions and Relevance


In this stepped-wedge cluster randomized clinical trial, an intervention that delivered machine learning mortality predictions with behavioral nudges to oncology clinicians significantly increased the rate of SICs among all patients and among patients with high mortality risk who were targeted by the intervention. Behavioral nudges combined with machine learning mortality predictions can positively influence clinician behavior and may be applied more broadly to improve care near the end of life.
Trial Registration


ClinicalTrials.gov Identifier: NCT03984773.",2020,"Among 4124 high-risk patient encounters, SICs were conducted among 3.6% in the control group and 15.2% in the intervention group, a significant difference (adjusted difference in percentage points, 11.6; 95% CI, 8.2-12.5; P < .001).
","['Patients With Cancer', '20 weeks (from June 17 to November 1, 2019) at 9 medical oncology clinics (8 subspecialty oncology and 1 general oncology clinics) within a large academic health system in Pennsylvania', 'patients with high mortality risk who were targeted by the intervention', '78 clinicians and 14\u202f607 patients', 'Included participants in the intention-to-treat analyses were 78 oncology clinicians who received SIC training and their patients (N\u2009=\u200914\u202f607) who had an outpatient oncology encounter during the study period', 'The mean (SD) age of patients was 61.9 (14.2) years, 53.7% were female, and 70.4% were White', 'Clinicians at the 2 smallest subspecialty clinics']","['Integrating Machine Learning Mortality Estimates', ""validated machine learning algorithm; and (3) opt-out text message prompts to clinicians on the patient's appointment day to consider an SIC"", 'usual care consisting of weekly emails with cumulative SIC performance']",['rate of SICs'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0025098', 'cui_str': 'Medical oncology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0030675', 'cui_str': 'Patient Appointments'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0013849', 'cui_str': 'Email'}]",[],78.0,0.119541,"Among 4124 high-risk patient encounters, SICs were conducted among 3.6% in the control group and 15.2% in the intervention group, a significant difference (adjusted difference in percentage points, 11.6; 95% CI, 8.2-12.5; P < .001).
","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Manz', 'Affiliation': 'Department of Population Sciences, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Ravi B', 'Initials': 'RB', 'LastName': 'Parikh', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'Small', 'Affiliation': 'Wharton School of the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Chalanda N', 'Initials': 'CN', 'LastName': 'Evans', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Chivers', 'Affiliation': 'University of Pennsylvania Health System, Philadelphia.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Regli', 'Affiliation': 'University of Pennsylvania Health System, Philadelphia.'}, {'ForeName': 'C William', 'Initials': 'CW', 'LastName': 'Hanson', 'Affiliation': 'University of Pennsylvania Health System, Philadelphia.'}, {'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Bekelman', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Charles A L', 'Initials': 'CAL', 'LastName': 'Rareshide', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Lynn M', 'Initials': 'LM', 'LastName': 'Schuchter', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Lawrence N', 'Initials': 'LN', 'LastName': 'Shulman', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA oncology,['10.1001/jamaoncol.2020.4759']
2816,33057739,Transcutaneous tibial nerve stimulation to treat urgency urinary incontinence in older women: 12-month follow-up of a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS


Urgency urinary incontinence (UUI) is highly prevalent in elderly individuals and has a great impact on quality of life. Transcutaneous tibial nerve stimulation (TTNS) can be an effective treatment option for UUI in older women.
METHODS


This is a single-center randomized clinical trial with a 12-month follow-up involving 106 women > 60 years of age. Kegel exercises and bladder retraining were performed alone or in combination with TTNS, which consisted of using a transcutaneous electrical nerve stimulator for 30 min once a week for 12 weeks with the following settings: continuous mode, 10 Hz, 200 ms, and 10 to 50 mA (according to hallux mobilization). Responders to therapy who experienced failure during follow-up were invited for a 3-week protocol with the same parameters as those used for the initial therapy. Patients were evaluated at baseline, 4 weeks after the 12-week protocol, and every 3 months for 12 months, through subjective satisfaction questionnaires, a 3-day bladder diary and the International Consultation on Incontinence Questionnaire-Short Form. King's Health Questionnaire was applied pretreatment and 4 weeks after the last session of the 12-week protocol.
RESULTS


A total of 101 women completed the initial 12-week protocol. TTNS patients reported 66.7% subjective global satisfaction vs. 32.0% in the control group (p < 0.001). The TTNS group showed statistically significant improvement in quality of life (QoL) and UUI parameters compared with the control group. Forty-eight patients were satisfied after the 12-week protocol and completed the 12-month follow-up (32 in the TTNS group and 16 in the control group). A total of 80.5% of responders to TTNS were still satisfied at the end of the 12-month follow-up vs. 30.8% in the control group (p = 0.009).
CONCLUSION


TTNS is effective at the 12-month follow-up for the treatment of UUI in elderly women.",2020,The TTNS group showed statistically significant improvement in quality of life (QoL) and UUI parameters compared with the control group.,"['101 women completed the initial 12-week protocol', 'elderly women', 'older women', 'elderly individuals', '106 women', ' 60\xa0years of age']","['Transcutaneous tibial nerve stimulation', 'TTNS', 'Kegel exercises and bladder retraining were performed alone or in combination with TTNS', 'Transcutaneous tibial nerve stimulation (TTNS']","['subjective global satisfaction', 'quality of life (QoL) and UUI parameters']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0262718', 'cui_str': 'Pelvic floor exercises'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",101.0,0.0333162,The TTNS group showed statistically significant improvement in quality of life (QoL) and UUI parameters compared with the control group.,"[{'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Schreiner', 'Affiliation': 'Gynecology Department, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Christiana Campani', 'Initials': 'CC', 'LastName': 'Nygaard', 'Affiliation': 'Gynecology Department, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil. cnygcnyg@gmail.com.'}, {'ForeName': 'Thais Guimarães', 'Initials': 'TG', 'LastName': 'Dos Santos', 'Affiliation': 'Gynecology Department, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Mara Regina', 'Initials': 'MR', 'LastName': 'Knorst', 'Affiliation': 'Gynecology Department, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Irênio Gomes', 'Initials': 'IG', 'LastName': 'da Silva Filho', 'Affiliation': 'Neurology Department, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}]",International urogynecology journal,['10.1007/s00192-020-04560-6']
2817,33057887,"Effect of St. John's wort oil and olive oil on the postoperative complications after third molar surgery: randomized, double-blind clinical trial.","OBJECTIVES


This multicenter study aimed to evaluate the effects of St. John's wort oil and virgin olive oil on the postoperative complications and compare this with chlorhexidine gluconate plus benzydamine hydrochloride mouthwash after the removal of impacted third molar.
METHODS


A total of 90 patients in need of impacted third molar surgery were included in this study. All included patients were randomly divided into 3 groups. The patients in group 1 received St. John's wort oil; the patients in group 2 received virgin olive oil, and those in group 3 received mouthwash containing chlorhexidine gluconate plus benzydamine hydrochloride. The self-reported pain and difficulty during jaw function, trismus, facial swelling, number of analgesics used during first postoperative week, and postoperative periodontal condition including plaque accumulation, bleeding on probing, and periodontal pocket depth were compared between the groups.
RESULTS


No significant differences were found regarding the study variables.
CONCLUSIONS


The data of the present study supports that the use of essential oils provides efficient alternative to the gold standard chlorhexidine gluconate mouthwash in reducing postoperative complications and improving healing process without adverse effects after surgical removal of impacted third molars.
CLINICAL RELEVANCE


The use of essential oils showed similar results as the chlorhexidine gluconate mouthwash regarding swelling, mouth opening, pain, need for rescue medication, infectious complications (i.e., alveolar osteitis), and periodontal healing. Therefore, essential oils can be an alternative to routine mouthwashes to ensure oral hygiene after impacted third molar surgery.",2020,"The use of essential oils showed similar results as the chlorhexidine gluconate mouthwash regarding swelling, mouth opening, pain, need for rescue medication, infectious complications (i.e., alveolar osteitis), and periodontal healing.","['90 patients in need of impacted third molar surgery', 'after third molar surgery']","['mouthwash containing chlorhexidine gluconate plus benzydamine hydrochloride', 'chlorhexidine gluconate mouthwash', 'virgin olive oil', ""St. John's wort oil"", ""St. John's wort oil and virgin olive oil"", 'chlorhexidine gluconate plus benzydamine hydrochloride mouthwash', ""St. John's wort oil and olive oil"", 'chlorhexidine gluconate']","['postoperative complications', 'swelling, mouth opening, pain, need for rescue medication, infectious complications (i.e., alveolar osteitis), and periodontal healing', 'pain and difficulty during jaw function, trismus, facial swelling, number of analgesics used during first postoperative week, and postoperative periodontal condition including plaque accumulation, bleeding on probing, and periodontal pocket depth']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0282070', 'cui_str': 'Benzydamine hydrochloride'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0813171', 'cui_str': ""ST. JOHN'S WORT EXTRACT""}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0013240', 'cui_str': 'Alveolar periostitis'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0031094', 'cui_str': 'Periodontal pocket'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",90.0,0.100533,"The use of essential oils showed similar results as the chlorhexidine gluconate mouthwash regarding swelling, mouth opening, pain, need for rescue medication, infectious complications (i.e., alveolar osteitis), and periodontal healing.","[{'ForeName': 'Volkan', 'Initials': 'V', 'LastName': 'Kaplan', 'Affiliation': 'Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Tekirdag Namik Kemal University, Tekirdag, Turkey. dr.volkankaplan61@gmail.com.'}, {'ForeName': 'Guzin Neda', 'Initials': 'GN', 'LastName': 'Hasanoglu Erbasar', 'Affiliation': 'Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Ankara Yıldırım Beyazıt University, Ankara, Turkey.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Cigerim', 'Affiliation': 'Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Van Yuzuncu Yil University, Van, Turkey.'}, {'ForeName': 'Hilal', 'Initials': 'H', 'LastName': 'Altay Turgut', 'Affiliation': 'Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Ankara Yıldırım Beyazıt University, Ankara, Turkey.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Cerit', 'Affiliation': 'Internal Medicine Specialist, Private Practice, Istanbul, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-020-03639-0']
2818,33059467,Exploration of the characteristics of chronotypes in upper gastrointestinal tract diseases: a multicenter study in Japan.,"Characteristics of the chronotypes of patients with gastrointestinal disease are unknown. We evaluated chronotypes of patients with upper gastrointestinal diseases with the Munich ChronoType Questionnaire (MCTQ). A total of 2027 subjects from 29 institutions in Japan who had undergone esophagogastroduodenoscopy were asked to answer the MCTQ. The subjects' chronotypes were divided into three groups (early, intermediate, and late chronotype) using the sleep-corrected mid-point of sleep on free days (MSF SC ) values. According to their endoscopic diagnosis and abdominal symptoms, the subjects were divided into the reflux esophagitis (RE) group, gastroduodenal ulcer (GDU) group, upper gastrointestinal carcinoma (CA) group, functional dyspepsia (FD) group, non-FD group, and control group. In total, 1128 subjects were eligible for the analysis. The MSF SC  (average ± standard deviation, clock hours, h) of each disease group was as follows: control group: 02.51 ± 1.22, non-FD group: 02.69 ± 1.14, FD group: 02.91 ± 1.19, RE group: 02.58 ± 1.05, GDU group: 02.47 ± 1.31, and CA group: 02.11 ± 1.08 h. Compared to the control group, the rate of late chronotype of the FD group significantly increased to 33.3%, whereas that of early chronotype of the CA group significantly increased to 38.3% ( P  = .0177 and 0.0036, respectively). In both the FD and CA groups, chronotype was the independent factor related to the diseases. The adjusted odds ratio of late chronotype to early chronotype was 3.01 [95% CI, 1.23-7.35] in the FD group and 0.44 [95% CI, 0.23-0.85] in the CA group. In conclusion, late chronotype was common in patients with FD, and early chronotype was common in patients with upper gastrointestinal carcinoma.",2020,"Compared to the control group, the rate of late chronotype of the FD group significantly increased to 33.3%, whereas that of early chronotype of the CA group significantly increased to 38.3% ( P  = .0177 and 0.0036, respectively).","['upper gastrointestinal tract diseases', 'patients with gastrointestinal disease', 'patients with upper gastrointestinal diseases with the Munich ChronoType Questionnaire (MCTQ', '1128 subjects were eligible for the analysis', 'subjects were divided into the reflux esophagitis (RE) group, gastroduodenal ulcer (GDU) group, upper gastrointestinal carcinoma (CA) group, functional dyspepsia (FD) group, non-FD group, and control group', '2027 subjects from 29 institutions in Japan who had undergone esophagogastroduodenoscopy']",['MCTQ'],"['rate of late chronotype', 'adjusted odds ratio of late chronotype to early chronotype']","[{'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0014869', 'cui_str': 'Esophagitis, Reflux'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030920', 'cui_str': 'Peptic ulcer'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0205300', 'cui_str': 'Non-functional'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",2027.0,0.0171479,"Compared to the control group, the rate of late chronotype of the FD group significantly increased to 33.3%, whereas that of early chronotype of the CA group significantly increased to 38.3% ( P  = .0177 and 0.0036, respectively).","[{'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Kiyotoki', 'Affiliation': 'Faculty of Laboratory Science, Yamaguchi University Graduate School of Medicine , Ube, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Gastroenterology, Shuto General Hospital , Yanai, Japan.'}, {'ForeName': 'Naoyoshi', 'Initials': 'N', 'LastName': 'Nagata', 'Affiliation': 'Department of Gastroenterological Endoscopy, Tokyo Medical University , Tokyo, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Niikura', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, the University of Tokyo , Tokyo, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Doyama', 'Affiliation': 'Department of Gastroenterology, Ishikawa Prefectural Central Hospital , Kanazawa, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Imagawa', 'Affiliation': 'Imagawa Medical Clinic , Kasada, Mitoyo, Japan.'}, {'ForeName': 'Kenkei', 'Initials': 'K', 'LastName': 'Hasatani', 'Affiliation': 'Department of Gastroenterology, Fukui Prefectural Hospital , Fukui, Japan.'}, {'ForeName': 'Waku', 'Initials': 'W', 'LastName': 'Hatta', 'Affiliation': 'Division of Gastroenterology, Tohoku University Graduate School of Medicine , Sendai, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Sumiyoshi', 'Affiliation': 'Department of Gastroenterology, Tonan Hospital , Chuo-ku, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Nebiki', 'Affiliation': 'Department of Gastroenterology, Osaka City General Hospital , Osaka, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Nagami', 'Affiliation': 'Department of Gastroenterology, Osaka City University Graduate School of Medicine , Osaka, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Nishida', 'Affiliation': 'Department of Gastroenterology, Toyonaka Municipal Hospital , Toyonaka, Japan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kakushima', 'Affiliation': 'Division of Endoscopy, Shizuoka Cancer Center , Suntougun, Japan.'}, {'ForeName': 'Mikitaka', 'Initials': 'M', 'LastName': 'Iguchi', 'Affiliation': 'Second Department of Internal Medicine, Wakayama Medical University , Wakayama, Japan.'}, {'ForeName': 'Hideomi', 'Initials': 'H', 'LastName': 'Tomida', 'Affiliation': 'Department of Gastroenterology, Ehime Prefectural Central Hospital , Matsuyama, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Gastroenterology and Hepatology, Osaka General Medical Center , Osaka, Japan.'}, {'ForeName': 'Shiko', 'Initials': 'S', 'LastName': 'Kuribayashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Gunma University Hospital , Maebashi, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Narasaka', 'Affiliation': 'Department of Gastroenterology, University of Tsukuba , Tsukuba, Japan.'}, {'ForeName': 'Takuto', 'Initials': 'T', 'LastName': 'Hikichi', 'Affiliation': 'Department of Endoscopy, Fukushima Medical University Hospital , Fukushima, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Yada', 'Affiliation': 'Department of Gastroenterology & Hepatology, Kohnodai Hospital, National Center for Global Health and Medicine , Ichikawa, Japan.'}, {'ForeName': 'Yorinari', 'Initials': 'Y', 'LastName': 'Ochiai', 'Affiliation': 'Department of Gastroenterology, Toranomon Hospital , Tokyo, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Furuhashi', 'Affiliation': 'Department of Endoscopy, The Jikei University School of Medicine , Tokyo, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Yoshio', 'Affiliation': 'Department of Gastroenterology, Cancer Institute Hospital , Tokyo, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Mori', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Tokyo Medical Center , Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Gastroenterology, Mitoyo General Hospital , Kannonji, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Kitamura', 'Affiliation': 'Department of Gastroenterology, Kanazawa University Hospital , Kanazawa, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Department of Medical Gastroenterology, Otaru-Ekisaikai Hospital , Otaru, Japan.'}, {'ForeName': 'Katsuhiro', 'Initials': 'K', 'LastName': 'Mabe', 'Affiliation': 'Junpukai Health Maintenance Center Kurashiki , Kurashiki, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Mikami', 'Affiliation': 'Division of Endoscopy, Hirosaki University Hospital , Hirosaki, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Goto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine , Ube, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Akashi', 'Affiliation': 'The Research Institute for Time Studies, Yamaguchi University , Yamaguchi, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Hamamoto', 'Affiliation': 'Department of Information Science and Engineering, Yamaguchi University Graduate School of Sciences and Technology for Innovation , Ube, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Fujishiro', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine , Nagoya, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Sakaida', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine , Ube, Japan.'}]",Chronobiology international,['10.1080/07420528.2020.1830791']
2819,33059519,The effect of electrical muscle stimulation on quadriceps muscle strength and activation patterns in healthy young adults.,"The aim of the present study was to clarify the effect of electrical muscle stimulation (EMS) on the spatial distribution pattern of electromyographic activity in healthy young adults using multi-channel surface electromyography (SEMG). A total of 32 men (age =21-26 years) were randomly assigned to the intervention group (n=18) and control group (n=14). Participants in the intervention group performed EMS to stimulate the bilateral lower limb muscle for four weeks (20 min/3 days/week). The control group received no EMS intervention. To understand the effects of EMS, following measurements were made at baseline and four weeks: knee extension torque, muscle mass, and spatial distribution of neuromuscular activation during a target torques [10%, 30%, 50%, and 70% of the maximal voluntary contraction (MVC)] using multi-channel SEMG. The knee extension torque was significantly increased in intervention group compared with control group ( p  < 0.0001). However, the muscle mass did not show a significant difference between pre and post intervention in each group. The muscle activation patterns of 50% and 70% MVC task showed significant enhancement between baseline and four weeks in the intervention group. Furthermore, a moderate correlation between Δ knee extension torque and Δ spatial distribution pattern of electromyographic activity of 50% and 70% MVC in the intervention group was observed. These results suggested EMS intervention induced different distribution of muscle activity at high-intensity muscle contraction compared with low-intensity muscle contraction.",2020,The knee extension torque was significantly increased in intervention group compared with control group ( p  < 0.0001).,"['healthy young adults', '32 men (age =21-26 years', 'healthy young adults using multi-channel surface electromyography (SEMG']","['maximal voluntary contraction (MVC)] using multi-channel SEMG', 'electrical muscle stimulation (EMS', 'EMS', 'EMS intervention', 'electrical muscle stimulation', 'no EMS intervention']","['knee extension torque', 'muscle activity', 'quadriceps muscle strength and activation patterns', 'muscle activation patterns', 'electromyographic activity']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",32.0,0.0425441,The knee extension torque was significantly increased in intervention group compared with control group ( p  < 0.0001).,"[{'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Nishikawa', 'Affiliation': 'Division of Rehabilitation, Department of Clinical Practice and Support, Hiroshima University Hospital, 1-2-3, Kasumi, Minami-ku, Hiroshima-shi, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Laboratory of Neuromuscular Biomechanics, School of International Liberal Studies, Chukyo University, Nagoya, 101-2, Yagoto Honmachi, Showa-ku, Nagoya-shi, Aichi, 466-8666, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences, 1-2-3, Kasumi, Minami-ku, Hiroshima-shi, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Maeda', 'Affiliation': 'Division of Sports Rehabilitation, Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3, Kasumi, Minami-ku, Hiroshima-shi, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Maruyama', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences, 1-2-3, Kasumi, Minami-ku, Hiroshima-shi, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kimura', 'Affiliation': 'Department of Rehabilitation Medicine, Hiroshima University Hospital, 1-2-3, Kasumi, Minami-ku, Hiroshima-shi, Hiroshima, 734-8551, Japan.'}]",European journal of sport science,['10.1080/17461391.2020.1838617']
2820,33059580,"Prevalence, diagnosis and treatment with 3 different statins of non-alcoholic fatty liver disease/non-alcoholic steatohepatitis in military personnel. Do genetics play a role?","BACKGROUND


Non-alcoholic fatty liver disease (NAFLD) and its severe form, non-alcoholic steatohepatitis (NASH), are major health problems worldwide. Genetics may play a role in the pathogenesis of NAFLD/NASH.
AIM


To investigate the prevalence of NAFLD/NASH in 5,400 military personnel and evaluate the effect of treatment with 3 statins on NAFLD/NASH using 2 non-invasive scores [NAFLD Activity Score (NAS); Fibrosis-4 score (FIB-4)].
METHODS


During the mandatory annual medical check-up, military personnel underwent a clinical and laboratory evaluation. Participants with NAFLD/NASH were randomised to 4 groups (n=151 each): dietexercise, atorvastatin, rosuvastatin or pitavastatin for 1 year (i.e. until the next routine evaluation).
RESULTS


From all the participants, 613 had NAFLD/NASH (prevalence 11.3 vs 39.8% in the general population, p<0.001); 604 consented to participate in the study. After a year of treatment, the diet-exercise group showed no significant changes in both scores (NAS 4.98 baseline vs 5.62, p=0.07; FIB-4 3.42 vs 3.52, p=0.7). For the atorvastatin group, both scores were reduced (NAS 4.97 vs 1.95, p<0.001, FIB-4 3.56 vs 0.83, p<0.001), for rosuvastatin (NAS 5.55 vs 1.81, p<0.001, FIB-4 3.61 vs 0.79, p<0.001), and for pitavastatin (NAS 4.89 vs 1.99, p<0.001, FIB-4 3.78 vs 0.87, p<0.001).
CONCLUSIONS


Atorvastatin, rosuvastatin and pitavastatin have a beneficial and safe effect in NAFLD/NASH patients as recorded by the improvement in the NAS (representing NAFLD activity) and FIB-4 (representing liver fibrosis) scores. Since both those with and without NAFLD/NASH shared several baseline characteristics, genetics may play a role in the pathogenesis of NAFLD/NASH and its treatment with statins.",2020,"After a year of treatment, the diet-exercise group showed no significant changes in both scores (NAS 4.98 baseline vs 5.62, p=0.07; FIB-4 3.42 vs 3.52, p=0.7).","['non-alcoholic fatty liver disease/non-alcoholic steatohepatitis in military personnel', '5,400 military personnel', 'Participants with NAFLD', 'From all the participants, 613 had NAFLD/NASH (prevalence 11.3 vs 39.8% in the general population, p<0.001); 604 consented to participate in the study']","['NASH', 'NAFLD/NASH', 'diet-exercise', 'Atorvastatin, rosuvastatin and pitavastatin', 'atorvastatin', 'dietexercise, atorvastatin, rosuvastatin or pitavastatin']",['NAFLD/NASH using 2 non-invasive scores [NAFLD Activity Score (NAS); Fibrosis-4 score (FIB-4'],"[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}]","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}]",5400.0,0.0782563,"After a year of treatment, the diet-exercise group showed no significant changes in both scores (NAS 4.98 baseline vs 5.62, p=0.07; FIB-4 3.42 vs 3.52, p=0.7).","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Sfikas', 'Affiliation': '1st Department of Internal Medicine, 424 General Military Training Hospital, Thessaloniki. Greece.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Psallas', 'Affiliation': '1st Department of Internal Medicine, 424 General Military Training Hospital, Thessaloniki. Greece.'}, {'ForeName': 'Charalambos', 'Initials': 'C', 'LastName': 'Koumaras', 'Affiliation': '1st Department of Internal Medicine, 424 General Military Training Hospital, Thessaloniki. Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Imprialos', 'Affiliation': '2nd Propedeutic Department of Internal Medicine, Hippocration Hospital, Aristotle University School of Medicine, Thessaloniki. Greece.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Perdikakis', 'Affiliation': 'Department of Ultrasonography, 424 General Military Training Hospital, Thessaloniki. Greece.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Doumas', 'Affiliation': '2nd Propedeutic Department of Internal Medicine, Hippocration Hospital, Aristotle University School of Medicine, Thessaloniki. Greece.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Giouleme', 'Affiliation': '2nd Propedeutic Department of Internal Medicine, Hippocration Hospital, Aristotle University School of Medicine, Thessaloniki. Greece.'}, {'ForeName': 'Asterios', 'Initials': 'A', 'LastName': 'Karagiannis', 'Affiliation': '2nd Propedeutic Department of Internal Medicine, Hippocration Hospital, Aristotle University School of Medicine, Thessaloniki. Greece.'}, {'ForeName': 'Vasilios G', 'Initials': 'VG', 'LastName': 'Athyros', 'Affiliation': '2nd Propedeutic Department of Internal Medicine, Hippocration Hospital, Aristotle University School of Medicine, Thessaloniki. Greece.'}]",Current vascular pharmacology,['10.2174/1570161118666201015152921']
2821,33057953,A Pharmacokinetic Bridging Study to Compare Systemic Exposure to Budesonide between Budesonide Oral Suspension and ENTOCORT EC in Healthy Individuals.,"BACKGROUND AND OBJECTIVES


Currently, there are no US FDA-approved therapies for eosinophilic esophagitis (EoE). Budesonide oral suspension (BOS; SHP621, TAK-721) is a viscous, muco-adherent, oral formulation of budesonide that is in phase III development for the treatment of EoE. BOS 2 mg twice daily was studied in 12- and 36-week phase III studies for the induction and maintenance of clinical remission in adults and adolescents with EoE (NCT02605837 and NCT02736409). ENTOCORT EC is a gelatin capsule formulation of budesonide that is FDA-approved for the treatment of mild-to-moderate active Crohn's disease (CD) in adults and children. This study compared the systemic exposure to budesonide from BOS with that from ENTOCORT EC, aiming to provide the pharmacokinetic (PK) bridge to the safety data of ENTOCORT EC.
METHODS


Healthy adult volunteers (n = 22) were enrolled in an open-label, single-center, crossover study. Participants received a single oral dose of BOS 2 mg and a single oral dose of ENTOCORT EC 9 mg under fasting conditions in a randomized sequence, with a 48-h washout period between treatments. PK parameters were calculated by non-compartmental analysis and compared between treatments using a mixed-effects model with sequence and treatment as fixed effects and individuals within sequence as a random effect.
RESULTS


Plasma budesonide concentrations showed that budesonide was absorbed significantly faster from BOS 2 mg than from ENTOCORT EC 9 mg, with peak concentrations reached at 1.5 and 4 h, respectively (p < 0.001). Systemic exposure to budesonide after a single oral dose of BOS 2 mg was lower than that observed after a single oral dose of ENTOCORT EC 9 mg; the least squares geometric mean maximum plasma concentration and the area under the concentration-time curve from the time of dosing to infinity and from the time of dosing to the last measurable concentration of budesonide after BOS 2 mg were 71.1%, 33.5%, and 33.6% of those after ENTOCORT EC 9 mg, respectively. No notable differences in treatment-emergent adverse events were observed between individuals treated with either drug; all events were mild and none resulted in discontinuation from the study.
CONCLUSIONS


This study demonstrated that systemic exposure to budesonide after a single oral dose of BOS 2 mg was lower than that after a single oral dose of ENTOCORT EC 9 mg. These results provide PK bridging data to compare BOS with therapeutic doses of ENTOCORT EC with respect to safety information.",2020,"No notable differences in treatment-emergent adverse events were observed between individuals treated with either drug; all events were mild and none resulted in discontinuation from the study.
","[""mild-to-moderate active Crohn's disease (CD) in adults and children"", 'Healthy adult volunteers (n\u2009=\u200922', 'Healthy Individuals']","['Budesonide', 'budesonide', 'Budesonide Oral Suspension and ENTOCORT EC', 'Budesonide oral suspension (BOS; SHP621, TAK-721']","['Plasma budesonide concentrations', 'PK parameters', 'treatment-emergent adverse events']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0592459', 'cui_str': 'Budesonide-containing product in oral dose form'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0593928', 'cui_str': 'Entocort'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",22.0,0.0485298,"No notable differences in treatment-emergent adverse events were observed between individuals treated with either drug; all events were mild and none resulted in discontinuation from the study.
","[{'ForeName': 'Ivy H', 'Initials': 'IH', 'LastName': 'Song', 'Affiliation': 'Shire Human Genetic Therapies, Inc., a Member of the Takeda Group of Companies, 300 Shire Way, Lexington, MA, 02421, USA. ivy.song@takeda.com.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Finkelman', 'Affiliation': 'Shire Human Genetic Therapies, Inc., a Member of the Takeda Group of Companies, 300 Shire Way, Lexington, MA, 02421, USA.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Lan', 'Affiliation': 'Shire Human Genetic Therapies, Inc., a Member of the Takeda Group of Companies, 300 Shire Way, Lexington, MA, 02421, USA.'}]",Drugs in R&D,['10.1007/s40268-020-00324-1']
2822,33057967,Quality-of-Life Comparison of Dapagliflozin Versus Dipeptidyl Peptidase 4 Inhibitors in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial (J-BOND Study).,"INTRODUCTION


No study has compared the effects of sodium-glucose cotransporter 2 inhibitors (SGLT2is) and dipeptidyl peptidase 4 inhibitors (DPP4is) on patients' quality-of-life (QOL).
METHODS


We enrolled 253 drug-naïve Japanese patients with type 2 diabetes mellitus (T2DM), randomly assigned them into a dapagliflozin (SGLT2i) group or DPP4i group in approximately 1:1 ratio, and monitored them for 24 weeks. The primary endpoint was the proportion of subjects indicating improvement in the ""overall quality of life"" domain of SHIELD-WQ-9 at week 24. Secondary endpoints included other domains of SHIELD-WQ-9, DTR-QOL, EQ-5D-5L, medication preference, medication adherence, diet therapy adherence, body weight, body mass index (BMI), abdominal circumference, HbA1c, and frequency of adverse events.
RESULTS


The proportion of subjects indicating improvement in the ""overall quality of life"" domain of SHIELD-WQ-9 at week 24 was higher in the dapagliflozin group (28.4%) than in the DPP4i group (18.6%) (p = 0.08). The proportion of subjects indicating improvement in the ""physical health"" domain of SHIELD-WQ-9 at week 24 was significantly higher in the dapagliflozin group (42.2%) than in the DPP4i group (23.7%) (p = 0.004). Total scores and domain 1 scores of DTR-QOL showed greater improvement in the dapagliflozin group (14.3 ± 15.6 and 15.5 ± 20.8, respectively) than in the DPP4i group (10.2 ± 15.6 and 10.3 ± 19.5, respectively) (both p = 0.05). EQ-5D-5L scores had significantly improved in the DPP4i group (0.023 ± 0.088) (p = 0.005); the intergroup difference was not significant (p = 0.14). Body weight (p < 0.001), BMI (p < 0.001), and abdominal circumference (p = 0.019) had significantly decreased in the dapagliflozin group compared with the corresponding values in the DPP4i group.
CONCLUSION


Dapagliflozin showed a comparable or more favorable benefit on Japanese patients' QOL compared with DPP4is. Dapagliflozin was well tolerated. It significantly reduced body weight, which was significantly correlated with improvement in the patients' QOL. This study demonstrates that dapagliflozin can be used as a first-line drug for T2DM in Japan with a beneficial impact on patients' QOL.
TRIAL REGISTRATION


University Hospital Medical Information Network Clinical Trial Registry (UMIN000030514); Japan Registry of Clinical Trials (jRCTs051180165).",2020,"Total scores and domain 1 scores of DTR-QOL showed greater improvement in the dapagliflozin group (14.3 ± 15.6 and 15.5 ± 20.8, respectively) than in the DPP4i group (10.2 ± 15.6 and 10.3 ± 19.5, respectively) (both p = 0.05).","['patients', 'Patients with Type\xa02 Diabetes Mellitus', '253 drug-naïve Japanese patients with type\xa02 diabetes mellitus (T2DM']","['dapagliflozin (SGLT2i) group or DPP4i', 'Dapagliflozin Versus Dipeptidyl Peptidase', 'sodium-glucose cotransporter\xa02 inhibitors (SGLT2is) and dipeptidyl peptidase\xa04 inhibitors (DPP4is', 'Dapagliflozin', 'dapagliflozin']","['BMI', 'overall quality of life"" domain of SHIELD-WQ-9', 'abdominal circumference', 'domains of SHIELD-WQ-9, DTR-QOL, EQ-5D-5L, medication preference, medication adherence, diet therapy adherence, body weight, body mass index (BMI), abdominal circumference, HbA1c, and frequency of adverse events', ""Japanese patients' QOL"", 'Total scores and domain\xa01 scores of DTR-QOL', 'physical health"" domain of SHIELD-WQ-9', 'EQ-5D-5L scores', 'body weight', 'tolerated', 'quality-of-life (QOL', 'proportion of subjects indicating improvement in the ""overall quality of life"" domain of SHIELD-WQ-9', 'Body weight']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012515', 'cui_str': 'Dipeptidylpeptide hydrolase'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C3884528', 'cui_str': 'HBEGF protein, human'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}]",253.0,0.039766,"Total scores and domain 1 scores of DTR-QOL showed greater improvement in the dapagliflozin group (14.3 ± 15.6 and 15.5 ± 20.8, respectively) than in the DPP4i group (10.2 ± 15.6 and 10.3 ± 19.5, respectively) (both p = 0.05).","[{'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ishii', 'Affiliation': 'Department of Doctor-Patient Relationships, Nara Medical University, Kashihara, Nara, Japan. hit3910@gmail.com.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Nakajima', 'Affiliation': 'Department of Diabetes and Endocrinology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Nozomu', 'Initials': 'N', 'LastName': 'Kamei', 'Affiliation': 'Hiroshima Red Cross Hospital and Atomic-Bomb Survivors Hospital, Hiroshima, Hiroshima, Japan.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Niiya', 'Affiliation': 'Matsuyama Shimin Hospital, Matsuyama, Ehime, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Hiyoshi', 'Affiliation': 'Division of Diabetes and Endocrinology, Japanese Red Cross Medical Center, Shibuya-ku, Tokyo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Hiramori', 'Affiliation': 'Suzuran-Naika Clinic of Medicine, Nara, Nara, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Ohtsu', 'Affiliation': 'Nakanoshima Diabetes Clinic, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Noto', 'Affiliation': 'Nishiyamato Diabetes Clinic, Kita-Katsuragi-gun, Nara, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Shimono', 'Affiliation': 'Futata Tetsuhiro Clinic, Fukuoka, Fukuoka, Japan.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00941-8']
2823,33057976,Effects of a Home-Based Intervention on HIV Prevention Health Behaviors in Pregnant/Postpartum Kenyan Women: Estimating Moderating Effects of Depressive Symptoms.,"We estimated effects of maternal depressive symptoms, utilizing the Patient Health Questionnaire-8 (PHQ-8), on women's HIV prevention behaviors in Migori County, Kenya. Pregnant women ≥ 18 years old, with gestational age of < 37 weeks, were randomized into standard care or three home visits (2 during pregnancy, 1 postpartum) promoting couple HIV testing and counseling (CHTC) and HIV prevention. Of 105 female participants, 37 (35.24%) reported depressive symptoms and 50 (47.62%) were HIV-positive. Three Poisson regressions with robust variance (univariable, multivariable, and multivariable with depressive symptoms/study arm interaction) were modeled for three outcomes: CHTC, infant HIV testing, health-seeking postpartum. In multivariable analysis with interaction, a moderating trend for the interaction between depressive symptoms and individual health-seeking was observed (p-value = 0.067). Women scoring ≤ 9 (n = 68) on the PHQ-8 and participating in home visits were 1.76 times more likely to participate in individual health-seeking compared to participants in standard care (ARR 1.76, 95% CI 1.17-2.66).",2020,"In multivariable analysis with interaction, a moderating trend for the interaction between depressive symptoms and individual health-seeking was observed (p-value = 0.067).","['Pregnant/Postpartum Kenyan Women', 'Pregnant women\u2009≥\u200918\xa0years old, with gestational age of\u2009<\u200937\xa0weeks', ""women's HIV prevention behaviors in Migori County, Kenya"", '105 female participants, 37 (35.24%) reported depressive symptoms and 50 (47.62%) were HIV-positive']","['Home-Based Intervention', 'standard care or three home visits (2 during pregnancy, 1 postpartum) promoting couple HIV testing and counseling (CHTC) and HIV prevention']","['depressive symptoms and individual health-seeking', 'individual health-seeking', 'HIV Prevention Health Behaviors']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",105.0,0.0745201,"In multivariable analysis with interaction, a moderating trend for the interaction between depressive symptoms and individual health-seeking was observed (p-value = 0.067).","[{'ForeName': 'Jami L', 'Initials': 'JL', 'LastName': 'Anderson', 'Affiliation': 'Department of Health Services Administration, School of Health Professions, University of Alabama at Birmingham, SHPB 553, 1716 9th Ave South, Birmingham, AL, 35294, USA. jamianderson@uab.edu.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Lynae A', 'Initials': 'LA', 'LastName': 'Darbes', 'Affiliation': 'Center for Sexuality and Health Disparities, Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Hatcher', 'Affiliation': 'School of Public Health, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Helova', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Zachary A', 'Initials': 'ZA', 'LastName': 'Kwena', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Musoke', 'Affiliation': 'Center for Social and Behavioral Research, University of Northern Iowa, Cedar Falls, IA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Owino', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Oyaro', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Anna Joy G', 'Initials': 'AJG', 'LastName': 'Rogers', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Turan', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",AIDS and behavior,['10.1007/s10461-020-03046-2']
2824,33057983,"Letter to the Editor Regarding 'A Multicentre, Randomised Clinical Trial to Compare a Topical Nitrizinc® Complex Solution Versus Cryotherapy for the Treatment of Anogenital Warts'.",,2020,,[],"['Cryotherapy', 'Topical Nitrizinc® Complex Solution']",[],[],"[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]",[],,0.0802192,,"[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Bertolotti', 'Affiliation': 'Service des Maladies Infectieuses - Dermatologie, Centre Hospitalier Universitaire (CHU) de La Réunion, Saint Pierre, La Réunion, France. antoine_bertolotti@yahoo.fr.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Derancourt', 'Affiliation': 'La Direction de la Recherche, Centre Hospitalier Universitaire (CHU) de Bordeaux, Bordeaux, France.'}]",Dermatology and therapy,['10.1007/s13555-020-00449-w']
2825,33057999,A randomized clinical trial comparing physician-directed or fixed-dose steroid replacement strategies for incomplete dexamethasone dosing prior to docetaxel chemotherapy.,"PURPOSE


Prior to docetaxel chemotherapy, incomplete dosing of steroid premedication is common. The lack of standardized steroid replacement strategies can lead to variability in care and delays in starting docetaxel.
METHODS


This randomized trial compared physician-directed with fixed-dose dexamethasone. Patients who had missed at least one dose of steroid premedication were randomized to physician-directed replacement (any choice of steroid, dose or route) or to dexamethasone 8 mg oral before starting docetaxel. The primary outcome was time from randomization to starting docetaxel. Secondary outcomes included rates of acute and delayed hypersensitivity reactions, fluid retention and skin toxicity.
RESULTS


Of 60 eligible patients, 30 (50%) and 30 (50%) were randomized to physician-directed and fixed-dose arms, respectively. Overall tumour types: breast (42 [70%]), gastrointestinal (7 [12%]), prostate (7 [12%]) and lung (3 [7%]). Dexamethasone was most commonly incompletely taken with cycles 1 (28 [48%]) and 2 (13 [22%]) of docetaxel. Seven different replacement strategies were used in the physician-choice arm. Patients in the fixed-dose arm received docetaxel a mean of 21.2 (95% CI for the difference is 2.1 to 44.6) minutes earlier than the physician-choice arm (p = 0.033 Wilcoxon rank sum test or p = 0.073 two-sample t test). Median time to docetaxel was 47.5 vs 61 min (mean 62.2 vs 83.4 min) by arm, respectively. No significant difference in toxicity rates was observed.
CONCLUSION


While not meeting our predefined criteria of improving the time from randomization to starting docetaxel by 30 min, the fixed-dose replacement strategy reduced both the time to starting docetaxel and treatment variability. Fixed dosing with oral dexamethasone 8 mg should be the preferred standard of care. REGISTRATION: www.clinicaltrials.gov NCT02815319 REGISTRATION DATE: June 28, 2016.",2020,"Median time to docetaxel was 47.5 vs 61 min (mean 62.2 vs 83.4 min) by arm, respectively.","['Patients who had missed at least one dose of steroid premedication', '60 eligible patients, 30 (50%) and 30 (50']","['physician-directed replacement (any choice of steroid, dose or route) or to dexamethasone 8\xa0mg oral before starting docetaxel', 'docetaxel chemotherapy', 'oral dexamethasone', 'physician-directed with fixed-dose dexamethasone', 'Dexamethasone', 'steroid premedication', 'docetaxel']","['rates of acute and delayed hypersensitivity reactions, fluid retention and skin toxicity', 'Median time to docetaxel', 'toxicity rates', 'time from randomization to starting docetaxel']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013153', 'cui_str': 'Route of administration'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0360528', 'cui_str': 'Dexamethasone-containing product in oral dose form'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0020522', 'cui_str': 'Cell-mediated immune reaction'}, {'cui': 'C0268000', 'cui_str': 'Body fluid retention'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]",60.0,0.175667,"Median time to docetaxel was 47.5 vs 61 min (mean 62.2 vs 83.4 min) by arm, respectively.","[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Hsu', 'Affiliation': 'Division of Medical Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Canada.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Fergusson', 'Affiliation': 'Department of Medicine, The University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Stober', 'Affiliation': 'Cancer Research Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Daigle', 'Affiliation': 'Department of Nursing, The Ottawa Hospital and the Ottawa Hospital Cancer Centre, Ottawa, Canada.'}, {'ForeName': 'Noorza', 'Initials': 'N', 'LastName': 'Moledina', 'Affiliation': 'Department of Nursing, The Ottawa Hospital and the Ottawa Hospital Cancer Centre, Ottawa, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Vandermeer', 'Affiliation': 'Cancer Research Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Pond', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hilton', 'Affiliation': 'Division of Medical Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hutton', 'Affiliation': 'Department of Medicine, The University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Clemons', 'Affiliation': 'Division of Medical Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Canada. mclemons@toh.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05791-5']
2826,33058277,The Ending Self-Stigma for Posttraumatic Stress Disorder (ESS-P) Program: Results of a Pilot Randomized Trial.,"Experiences of and concerns about encountering stigma are common among veterans with posttraumatic stress disorder (PTSD). One common and serious consequence is self-stigma, which is when an individual comes to believe that common negative stereotypes and assumptions about PTSD are true of oneself. The current study was a pilot randomized trial that evaluated the feasibility, acceptability, and preliminary outcomes of the Ending Self-Stigma for PTSD (ESS-P) program, a nine-session group intervention that aims to assist veterans with PTSD learn tools and strategies to address stigma and self-stigma. Veterans (N = 57) with a diagnosis of PTSD who were receiving treatment in U.S. Veterans Health Administration outpatient mental health programs were recruited. Participants were randomized to either ESS-P or minimally enhanced treatment as usual and assessed at baseline and after treatment on clinical symptoms, self-stigma, self-efficacy, recovery, and sense of belonging. Information on mental health treatment utilization for the 3 months before and after group treatment was also collected. Compared to controls, there was a significant decrease in self-stigma, d = -0.77, and symptoms of depression, d = -0.76, along with significant increases in general and social self-efficacy, ds = 0.73 and 0.60, respectively, and psychological experience of belonging, d = 0.46, among ESS-P participants. There were no differences regarding recovery status or changes in treatment utilization. The results of the pilot study suggest that participation in ESS-P may help reduce self-stigma and improve self-efficacy and a sense of belonging in veterans with PTSD.",2020,"Compared to controls, there was a significant decrease in self-stigma, d = -0.77, and symptoms of depression, d = -0.76, along with significant increases in general and social self-efficacy, ds = 0.73 and 0.60, respectively, and psychological experience of belonging, d = 0.46, among ESS-P participants.","['Veterans (N = 57) with a diagnosis of PTSD who were receiving treatment in U.S. Veterans Health Administration outpatient mental health programs were recruited', 'Posttraumatic Stress Disorder', 'veterans with posttraumatic stress disorder (PTSD', 'veterans with PTSD']","['Ending Self-Stigma for PTSD', 'ESS-P or minimally enhanced treatment']","['self-stigma and improve self-efficacy', 'self-stigma', 'general and social self-efficacy']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",57.0,0.0178217,"Compared to controls, there was a significant decrease in self-stigma, d = -0.77, and symptoms of depression, d = -0.76, along with significant increases in general and social self-efficacy, ds = 0.73 and 0.60, respectively, and psychological experience of belonging, d = 0.46, among ESS-P participants.","[{'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Drapalski', 'Affiliation': 'VA Capital Health Care (VISN 5) Mental Illness Research, Education and Clinical Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Aakre', 'Affiliation': 'Minneapolis VA Health Care System, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Clayton H', 'Initials': 'CH', 'LastName': 'Brown', 'Affiliation': 'VA Capital Health Care (VISN 5) Mental Illness Research, Education and Clinical Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Romero', 'Affiliation': 'VA Capital Health Care (VISN 5) Mental Illness Research, Education and Clinical Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Lucksted', 'Affiliation': 'VA Capital Health Care (VISN 5) Mental Illness Research, Education and Clinical Center, Baltimore, Maryland, USA.'}]",Journal of traumatic stress,['10.1002/jts.22593']
2827,33058366,Effects of Perioperative Comprehensive Nursing Based on Risk Prevention for Patients with Intracranial Aneurysm.,"OBJECTIVE


To explore the effect of comprehensive nursing based on risk prevention in perioperative nursing of intracranial aneurysm.
METHODS


A total of 156 patients who suffered from intracranial aneurysm were admitted in neurosurgery department from the hospital between January 2018 and January 2019. Patients were randomly divided into observation group (n = 78, patients were given comprehensive nursing based on risk prevention) and control group (n = 78, patients were given routine nursing). The following parameters, such as postoperative hospital stay, rescue success rate, Glasgow coma scale (GCS) after being awake, anxiety degree and nursing effect (incidence of complications, incidence of infection and patient satisfaction) were compared between the two groups.
RESULTS


The postoperative hospital stay, rescue success rate and GCS after intervention in the observation group were significantly better than those in the control group (p < 0.05). The degree of anxiety in the observation group after intervention was superior to that in the control group (p < 0.05), similar results were obtained in terms of the nursing effect in the observation group compared with the control group (p < 0.05).
CONCLUSION


Comprehensive nursing was associated with the shortness of hospitalization time of patients, improved rescue rate, reduced occurrence of complications and infection, and improved satisfaction of patients. Thus, comprehensive nursing was regarded to exert protective effect with a promising future for clinical practice.",2020,"The degree of anxiety in the observation group after intervention was superior to that in the control group (p < 0.05), similar results were obtained in terms of the nursing effect in the observation group compared with the control group (p < 0.05).
","['Patients with Intracranial Aneurysm', '156 patients who suffered from intracranial aneurysm were admitted in neurosurgery department from the hospital between January 2018 and January 2019']","['comprehensive nursing based on risk prevention) and control group', 'Perioperative Comprehensive Nursing', 'comprehensive nursing']","['rescue rate, reduced occurrence of complications and infection, and improved satisfaction', 'postoperative hospital stay, rescue success rate, Glasgow coma scale (GCS) after being awake, anxiety degree and nursing effect (incidence of complications, incidence of infection and patient satisfaction', 'postoperative hospital stay, rescue success rate and GCS', 'shortness of hospitalization time', 'degree of anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",156.0,0.0144321,"The degree of anxiety in the observation group after intervention was superior to that in the control group (p < 0.05), similar results were obtained in terms of the nursing effect in the observation group compared with the control group (p < 0.05).
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Operating Room, Linyi Central Hospital, Linyi, Shandong, China.'}, {'ForeName': 'Rong-Ye', 'Initials': 'RY', 'LastName': 'Wang', 'Affiliation': 'Operating Room, Linyi Central Hospital, Linyi, Shandong, China.'}, {'ForeName': 'Yu-Hong', 'Initials': 'YH', 'LastName': 'Zhao', 'Affiliation': 'Operating Room, Linyi Central Hospital, Linyi, Shandong, China.'}]",International journal of clinical practice,['10.1111/ijcp.13761']
2828,33059607,A novel Vi-diphtheria toxoid typhoid conjugate vaccine is safe and can induce immunogenicity in healthy Indonesian children 2-11 years: a phase II preliminary report.,"BACKGROUND


Typhoid fever caused by Salmonella enteric serovar Typhi (S. Typhi) is a common cause of morbidity in the world. In 2017, 14.3 million cases of Typhoid and paratyphoid fever occurred globally. School age children between 3 to 19 years old are the most affected. Poor sanitation and multi drug resistance have increased the need for vaccines to reduce the global burden of disease. Based on previous trials, typhoid conjugate vaccines have longer- lasting protection, higher efficacy, require fewer doses and are suitable from infancy that allows them to be incorporated into the routine immunization program. Our previous phase I trial proved that a novel Vi-DT typhoid conjugate vaccine is safe and immunogenic in subjects 2-5 and 18-40 years. Our phase II trial consisted of subjects 6 months to 40 years. Our previously published paper on subjects 6 to < 24 months proved that this vaccine is safe and immunogenic for this age group. Therefore, with this paper we aimed to evaluate the safety and immunogenicity in children 2-11 years.
METHODS


A randomized, observer-blind, superiority design of Vi-DT Typhoid conjugate vaccine compared to Vi-polysaccharide vaccine (Vi-PS) phase II study was conducted from October 2018 to December 2018 where 200 subjects aged 2-11 years were recruited. A blood sample prior to vaccination was taken, followed by administration of a single dose of either test vaccine (Vi-DT) or control vaccine (Vi-PS) and then a second blood sample was collected 28 days post vaccination. Adverse reactions were assessed and antibody increment was evaluated at 28 days post vaccination through collected serum sample.
RESULTS


Pain was the most common local reaction. Fever and muscle pain were the most common systemic reactions. Both Vi-DT and Vi-PS groups had roughly the same number of adverse reactions. At 28 days post vaccination, 100% of subjects in the Vi-DT group and 93% of subjects in the Vi-PS group produced antibody increment ≥4 times. The Vi-DT group produced a higher GMT as compared to Vi-PS.
CONCLUSION


Vi-DT vaccine is safe and immunogenic in children 2-11 years old.
TRIAL REGISTRATION


Trial registration number: NCT03460405 .",2020,I trial proved that a novel Vi-DT typhoid conjugate vaccine is safe and immunogenic in subjects 2-5 and 18-40 years.,"['children 2-11\u2009years old', 'subjects 2-5 and 18-40\u2009years', 'October 2018 to December 2018 where 200 subjects aged 2-11\u2009years were recruited', 'children 2-11\u2009years', 'healthy Indonesian children 2-11\u2009years', 'School age children between 3 to 19\u2009years old are the most affected']","['Vi-DT Typhoid conjugate vaccine', 'Vi-DT vaccine', 'vaccine (Vi-DT) or control vaccine (Vi-PS', 'diphtheria toxoid typhoid conjugate vaccine', 'Vi-polysaccharide vaccine (Vi-PS', 'novel Vi-DT typhoid conjugate vaccine']","['Fever and muscle pain', 'adverse reactions', 'safety and immunogenicity', 'Adverse reactions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021248', 'cui_str': 'Indonesian language'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}]","[{'cui': 'C0041466', 'cui_str': 'Typhoid fever'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0058773', 'cui_str': 'Diphtheria + tetanus vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012551', 'cui_str': 'diphtheria toxoid vaccine, inactivated'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.335723,I trial proved that a novel Vi-DT typhoid conjugate vaccine is safe and immunogenic in subjects 2-5 and 18-40 years.,"[{'ForeName': 'Bernie Endyarni', 'Initials': 'BE', 'LastName': 'Medise', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no, Jakarta, 71, Indonesia. bernie.medise@yahoo.com.'}, {'ForeName': 'Soedjatmiko', 'Initials': 'S', 'LastName': 'Soedjatmiko', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no, Jakarta, 71, Indonesia.'}, {'ForeName': 'Hartono', 'Initials': 'H', 'LastName': 'Gunardi', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no, Jakarta, 71, Indonesia.'}, {'ForeName': 'Rini', 'Initials': 'R', 'LastName': 'Sekartini', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no, Jakarta, 71, Indonesia.'}, {'ForeName': 'Hindra Irawan', 'Initials': 'HI', 'LastName': 'Satari', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no, Jakarta, 71, Indonesia.'}, {'ForeName': 'Sri Rezeki', 'Initials': 'SR', 'LastName': 'Hadinegoro', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no, Jakarta, 71, Indonesia.'}, {'ForeName': 'Angga', 'Initials': 'A', 'LastName': 'Wirahmadi', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no, Jakarta, 71, Indonesia.'}, {'ForeName': 'Mita', 'Initials': 'M', 'LastName': 'Puspita', 'Affiliation': 'PT. Bio Farma, Bandung, Indonesia.'}, {'ForeName': 'Rini Mulia', 'Initials': 'RM', 'LastName': 'Sari', 'Affiliation': 'PT. Bio Farma, Bandung, Indonesia.'}, {'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Yang', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Sil', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Sushant', 'Initials': 'S', 'LastName': 'Sahastrabuddhe', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Novilia Sjafri', 'Initials': 'NS', 'LastName': 'Bachtiar', 'Affiliation': 'PT. Bio Farma, Bandung, Indonesia.'}]",BMC pediatrics,['10.1186/s12887-020-02375-4']
2829,33059610,The MAKS-s study: multicomponent non-pharmacological intervention for people with severe dementia in inpatient care - study protocol of a randomised controlled trial.,"BACKGROUND


Nursing homes accommodate a large number of people with severe dementia. More than 80% of residents with dementia suffer from behavioural and psychological symptoms, that can have consequences on the perceived burden of the formal caregivers. Internationally, the number of studies on non-pharmacological interventions for people with severe dementia is very small. One way to reduce these symptoms is to meet the needs of people with severe dementia. The non-pharmacological group intervention MAKS-s, which we will investigate in this study, is intended to reduce the behavioural and psychological symptoms and to improve the quality of life of such people. Additionally, we will investigate the effects on the burden carried by formal caregivers.
METHODS


With the present study, we will investigate the effectiveness of a multicomponent non-pharmacological intervention for people with severe dementia living in nursing homes (primary target group). A power analysis indicated that 144 dementia participants should initially be included. In addition, a secondary target group (nursing home staff) will be examined with respect to their dementia-related stress experiences. The study will be conducted as a cluster randomised controlled trail in Germany with a 6-month intervention phase. The nursing homes in the waitlist control group will provide ""care as usual."" The primary endpoints of the study will be the behavioural and psychological symptoms of dementia and the quality of life of people with severe dementia. The total duration of the study will be 18 months. Data will be collected by using observer rating scales.
DISCUSSION


The project has some outstanding quality features. The external validity is high, because it is situated in a naturalistic setting in nursing homes and is being carried out with available nursing employees. Due to this fact, a permanent implementation also seems to be possible. Since the participating nursing homes are disseminated across several German federal states and rural and urban regions, the results should be transferable to the entire population.
TRIAL REGISTRATION


ISRCTN15722923 (Registration date: 07 August 2019).",2020,"The non-pharmacological group intervention MAKS-s, which we will investigate in this study, is intended to reduce the behavioural and psychological symptoms and to improve the quality of life of such people.","['144 dementia participants should initially be included', 'people with severe dementia', 'people with severe dementia living in nursing homes (primary target group', 'people with severe dementia in inpatient care - study protocol']",['multicomponent non-pharmacological intervention'],"['behavioural and psychological symptoms of dementia and the quality of life of people with severe dementia', 'quality of life of such people']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3494652', 'cui_str': 'Severe dementia'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]","[{'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3494652', 'cui_str': 'Severe dementia'}]",144.0,0.107316,"The non-pharmacological group intervention MAKS-s, which we will investigate in this study, is intended to reduce the behavioural and psychological symptoms and to improve the quality of life of such people.","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Diehl', 'Affiliation': 'Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany. kristina.diehl@uk-erlangen.de.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Kratzer', 'Affiliation': 'Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany.'}, {'ForeName': 'Elmar', 'Initials': 'E', 'LastName': 'Graessel', 'Affiliation': 'Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany.'}]",BMC geriatrics,['10.1186/s12877-020-01807-1']
2830,33059633,"Design of the Pregnancy REmote MOnitoring II study (PREMOM II): a multicenter, randomized controlled trial of remote monitoring for gestational hypertensive disorders.","BACKGROUND


Observational data from the retrospective, non-randomized Pregnancy REmote MOnitoring I (PREMOM I) study showed that remote monitoring (RM) may be beneficial for prenatal observation of women at risk for gestational hypertensive disorders (GHD) in terms of clinical outcomes, health economics, and stakeholder perceptions. PREMOM II is a prospective, randomized, multicenter follow-up study that was performed to explore these promising results.
METHODS


After providing written consent, 3922 pregnant women aged ≥18 years who are at increased risk of developing GHD will be randomized (1:1:1 ratio) to (a) conventional care (control group), (b) a patient self-monitoring group, and (c) a midwife-assisted RM group. The women in each group will be further divided (1:1 ratio) to evaluate the outcomes of targeted or non-targeted (conventional) antihypertensive medication. Women will be recruited in five hospitals in Flanders, Belgium: Ziekenhuis Oost-Limburg, Universitaire Ziekenhuis Antwerpen, Universitaire Ziekenhuis Leuven, AZ Sint Jan Brugge-Oostende, and AZ Sint Lucas Brugge. The primary outcomes are: (1) numbers and types of prenatal visits; (2) maternal outcomes; (3) neonatal outcomes; (4) the applicability and performance of RM; and (5) compliance with RM and self-monitoring. The secondary outcomes are: (1) cost-effectiveness and willingness to pay; (2) patient-reported outcome measures (PROMS) questionnaires on the experiences of the participants; and (3) the maternal and perinatal outcomes according to the type of antihypertensive medication. Demographic, and maternal and neonatal outcomes are collected from the patients' electronic records. Blood pressure and compliance rate will be obtained from an online digital coordination platform for remote data handling. Information about the healthcare-related costs will be obtained from the National Coordination Committee of Belgian Health Insurance Companies (Intermutualistisch Agentschap). PROMS will be assessed using validated questionnaires.
DISCUSSION


To our knowledge, this is the first randomized trial comparing midwife-assisted RM and self-monitoring of prenatal blood pressure versus conventional management among women at increased risk of GHD. Positive results of this study may lead to a practical framework for caregivers, hospital management, and payers to introduce RM into the prenatal care programs of high-risk pregnancies.
TRIAL REGISTRATION


This study was registered on clinicaltrials.gov , identification number NCT04031430. Registered 24 July 2019, https://clinicaltrials.gov/ct2/show/NCT04031430?cond=premom+ii&draw=2&rank=1 .",2020,The primary outcomes are: (1) numbers and types of prenatal visits; (2) maternal outcomes; (3) neonatal outcomes; (4) the applicability and performance of RM; and (5) compliance with RM and self-monitoring.,"['women at increased risk of GHD', 'Women will be recruited in five hospitals in Flanders, Belgium', '3922 pregnant women aged ≥18\u2009years who are at increased risk of developing GHD', 'women at risk for gestational hypertensive disorders (GHD', 'gestational hypertensive disorders']","['targeted or non-targeted (conventional) antihypertensive medication', 'midwife-assisted RM and self-monitoring of prenatal blood pressure versus conventional management', 'remote monitoring (RM', 'conventional care (control group), (b) a patient self-monitoring group, and (c) a midwife-assisted RM group']","['Blood pressure and compliance rate', ' (1) numbers and types of prenatal visits; (2) maternal outcomes; (3) neonatal outcomes; (4) the applicability and performance of RM; and (5) compliance with RM and self-monitoring', 'cost-effectiveness and willingness to pay; (2) patient-reported outcome measures (PROMS) questionnaires on the experiences of the participants; and (3) the maternal and perinatal outcomes according to the type of antihypertensive medication']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1875156', 'cui_str': 'Flanders'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1827763', 'cui_str': 'Prenatal visit'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",3922.0,0.142827,The primary outcomes are: (1) numbers and types of prenatal visits; (2) maternal outcomes; (3) neonatal outcomes; (4) the applicability and performance of RM; and (5) compliance with RM and self-monitoring.,"[{'ForeName': 'Dorien', 'Initials': 'D', 'LastName': 'Lanssens', 'Affiliation': 'Ziekenhuis Oost-Limburg, Future Health Department, Limburg Clinical Research Center/Mobile Health Unit, Genk, Belgium. Dorien.lanssens@uhasselt.be.'}, {'ForeName': 'Inge M', 'Initials': 'IM', 'LastName': 'Thijs', 'Affiliation': 'Ziekenhuis Oost-Limburg, Future Health Department, Limburg Clinical Research Center/Mobile Health Unit, Genk, Belgium.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Gyselaers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03291-2']
2831,33059638,Effects of prenatal mindfulness-based childbirth education on child-bearers' trajectories of distress: a randomized control trial.,"BACKGROUND


The perinatal period is a time of immense change, which can be a period of stress and vulnerability for mental health difficulties. Mindfulness-based interventions have shown promise for reducing distress, but further research is needed to identify long-term effects and moderators of mindfulness training in the perinatal period.
METHODS


The current study used data from a pilot randomized control trial (RCT) comparing a condensed mindfulness-based childbirth preparation program-the Mind in Labor (MIL)-to treatment as usual (TAU) to examine whether prenatal mindfulness training results in lower distress across the perinatal period, and whether the degree of benefit depends on child-bearers' initial levels of risk (i.e., depression and anxiety symptoms) and protective (i.e., mindfulness) characteristics. Child-bearers (N = 30) in their third trimester were randomized to MIL or TAU and completed assessments of distress-perceived stress, anxiety, and depressive symptoms-at pre-intervention, post-intervention, six-weeks post-birth, and one-year postpartum.
RESULTS


Multilevel modeling of distress trajectories revealed greater decreases from pre-intervention to 12-months postpartum for those in MIL compared to TAU, especially among child-bearers who were higher in anxiety and/or lower in dispositional mindfulness at baseline.
CONCLUSIONS


The current study offers preliminary evidence for durable perinatal mental health benefits following a brief mindfulness-based program and suggests further investigation of these effects in larger samples is warranted.
TRIAL REGISTRATION


The ClinicalTrials.gov identifier for the study is: NCT02327559 . The study was retrospectively registered on June 23, 2014.",2020,"Multilevel modeling of distress trajectories revealed greater decreases from pre-intervention to 12-months postpartum for those in MIL compared to TAU, especially among child-bearers who were higher in anxiety and/or lower in dispositional mindfulness at baseline.
","[""child-bearers' trajectories of distress""]","['MIL or TAU', 'prenatal mindfulness-based childbirth education', 'prenatal mindfulness training', 'condensed mindfulness-based childbirth preparation program-the Mind in Labor (MIL)-to treatment as usual (TAU']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3658257', 'cui_str': 'Childbirth Education'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150169', 'cui_str': 'Childbirth preparation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0852966,"Multilevel modeling of distress trajectories revealed greater decreases from pre-intervention to 12-months postpartum for those in MIL compared to TAU, especially among child-bearers who were higher in anxiety and/or lower in dispositional mindfulness at baseline.
","[{'ForeName': 'Marissa D', 'Initials': 'MD', 'LastName': 'Sbrilli', 'Affiliation': 'Department of Psychology, University of Illinois at Urbana-Champaign, Psychology Building, 603 E Daniel St, Champaign, IL, 61820, USA. sbrilli2@illinois.edu.'}, {'ForeName': 'Larissa G', 'Initials': 'LG', 'LastName': 'Duncan', 'Affiliation': 'School of Human Ecology, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'Heidemarie K', 'Initials': 'HK', 'LastName': 'Laurent', 'Affiliation': 'Department of Psychology, University of Illinois at Urbana-Champaign, Psychology Building, 603 E Daniel St, Champaign, IL, 61820, USA.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03318-8']
2832,33059650,Impact of pulmonary rehabilitation on patients' health care needs and asthma control: a quasi-experimental study.,"BACKGROUND


Pulmonary rehabilitation offers potential benefits to people with asthma. It is however unknown if rehabilitation favourably affects patients' health care needs. We therefore examined if rehabilitation reduced needs and, in addition, if it improved asthma control.
METHODS


One hundred fifty patients with asthma were surveyed in three rehabilitation clinics at admission and at discharge. Additionally, we surveyed 78 participants with asthma twice 4 weeks apart. The latter sample (i.e. the control group) was recruited through other pathways than rehabilitation clinics. The Patient Needs in Asthma Treatment (NEAT) questionnaire and the Asthma Control Test (ACT) were completed at baseline and follow-up. Differences between baseline and follow-up and between rehabilitation and control group were examined by t-tests and chi-squared-tests. Univariate ANCOVAS were used to examine if NEAT and ACT follow-up scores differed significantly between groups. Within the rehabilitation group, linear regressions were used to examine if self-reported utilization of more interventions that addressed needs were associated with NEAT scores at follow-up.
RESULTS


At baseline, there were no differences between the rehabilitation and the control group regarding needs and asthma control. At follow-up, the rehabilitation group showed reduced needs (t(149) = 10.33, p <  0.01) and increased asthma control (t(130) = -6.67, p <  0.01), whereas members of the control group exhibited no changes. Univariate ANCOVAS showed that unmet follow-up needs (F(1, 212) = 36.46, p <  0.001) and follow-up asthma control (F(1, 195) = 6.97, p = 0.009) differed significantly between groups. In the rehabilitation group, self-reported utilization of more interventions was associated with reduced needs (β = 0.21; p = 0.03).
CONCLUSIONS


This study provides preliminary evidence suggestion that pulmonary rehabilitation in adults with asthma may reduce asthma-related needs and confirms previous findings that rehabilitation may improve asthma control.",2020,"In the rehabilitation group, self-reported utilization of more interventions was associated with reduced needs (β = 0.21; p = 0.03).
","['78 participants with asthma twice 4 weeks apart', 'people with asthma', 'adults with asthma', 'One hundred fifty patients with asthma were surveyed in three rehabilitation clinics at admission and at discharge', ""patients' health care needs and asthma control""]",['pulmonary rehabilitation'],[],"[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]",[],78.0,0.035197,"In the rehabilitation group, self-reported utilization of more interventions was associated with reduced needs (β = 0.21; p = 0.03).
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Salandi', 'Affiliation': 'Institute of Occupational, Social, and Environmental Medicine, Centre for Health and Society, Medical Faculty, University of Düsseldorf, Moorenstraße 5, 40225, Düsseldorf, Germany. julia.schreitmueller@uni-duesseldorf.de.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Icks', 'Affiliation': 'Institute of Health Services Research and Health Economics, Centre for Health and Society, Medical Faculty, University of Düsseldorf, Moorenstraße 5, 40225, Düsseldorf, Germany.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Gholami', 'Affiliation': 'Nordseeklinik Borkum der DRV Rheinland, Bubertstraße 4, 26757, Borkum, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hummel', 'Affiliation': 'MEDIAN Klinik Heiligendamm, Kinderstrand 1, 18209, Bad Doberan, Germany.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Schultz', 'Affiliation': 'Klinik Bad Reichenhall der DRV Bayern Süd, Salzburger Str. 8-11, 83435, Bad Reichenhall, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Apfelbacher', 'Affiliation': 'Institute of Social Medicine and Health Systems Research (ISMHSR), Otto von Guericke University Magdeburg, Leipziger Str. 44, 39120, Magdeburg, Germany.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'Usher Institute, University of Edinburgh, Old Medical School, Teviot Place, Edinburgh, EH8 9AG, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Loerbroks', 'Affiliation': 'Institute of Occupational, Social, and Environmental Medicine, Centre for Health and Society, Medical Faculty, University of Düsseldorf, Moorenstraße 5, 40225, Düsseldorf, Germany.'}]",BMC pulmonary medicine,['10.1186/s12890-020-01301-9']
2833,33059669,"Long-lasting insecticide-treated bed net ownership, utilization and associated factors among school-age children in Dara Mallo and Uba Debretsehay districts, Southern Ethiopia.","BACKGROUND


Malaria is one of the major causes of morbidity and mortality among school-age children (SAC) in sub-Saharan Africa. SAC account for more than 60% of the reservoir of malaria transmission, but they are given less emphasis in prioritizing malaria prevention interventions. This study was aimed at assessing the ownership of long-lasting insecticide treated bed nets (LLINs), its utilization and factors associated with ownership of LLINs by households and LLINs utilization among SAC in malaria-prone areas of Dara Mallo and Uba Debretsehay districts in Southern Ethiopia, October to December 2019.
METHODS


This study is part of a baseline assessment in a cluster-randomized controlled trial. The data was collected through interview and observation, following a structured questionnaire, of 2261 SAC households. Univariable and multivariable multilevel logistic regressions were used to assess the association between LLINs ownership and utilization and potential predictor variables. Odds ratio (OR) and corresponding 95% confidence interval (CI) were used to determine the strength and statistical significance of association.
RESULTS


The ownership of at least one LLIN by households of SAC was about 19.3% (95% CI 17.7-21.0%) but only 10.3% % (95% CI 7.7-13.7%) of these households had adequate access of bed nets to the household members. Ownership of bed net was marginally affected by living in semi-urban area (adjusted OR = 2.6; 95% CI 1.0-6.9) and occupational status of the household head being a civil servant (adjusted OR = 2.7; 95% CI 0.9-7.9). About 7.8% (95% CI 6.7-10.0%) of all SAC participated in the study and 40.4% (95% CI 57.4-66.7%) of children in households owning at least one LLIN passed the previous night under LLIN. LLIN utilization by SAC conditional to presence of at least one net in the household was significantly correlated with education level of mother above grade 6 (adjusted OR = 3.4; 95% CI 1.3-9.3) and the household size to bed net ratio less than or equal to 2 (adjusted OR = 20.7; 95% CI 4.7-132.5).
CONCLUSION


Ownership of bed net was lower than universal coverage of at least one bed net for two individuals. It is important to monitor replacement needs and educate mothers with low education level with their SAC on the benefit of consistent utilization of bed nets.",2020,Ownership of bed net was marginally affected by living in semi-urban area (adjusted OR = 2.6; 95% CI 1.0-6.9) and occupational status of the household head being a civil servant (adjusted OR = 2.7; 95% CI 0.9-7.9).,"['2261 SAC households', 'school-age children (SAC) in sub-Saharan Africa', 'malaria-prone areas of Dara Mallo and Uba Debretsehay districts in Southern Ethiopia, October to December 2019', 'school-age children in Dara Mallo and Uba Debretsehay districts, Southern Ethiopia']",['ownership of long-lasting insecticide treated bed nets (LLINs'],"['Odds ratio (OR', 'Ownership of bed net', 'LLIN utilization']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}]","[{'cui': 'C0029981', 'cui_str': 'Ownership'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2717999', 'cui_str': 'Insecticide-Treated Bed Nets'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0029981', 'cui_str': 'Ownership'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",2261.0,0.115165,Ownership of bed net was marginally affected by living in semi-urban area (adjusted OR = 2.6; 95% CI 1.0-6.9) and occupational status of the household head being a civil servant (adjusted OR = 2.7; 95% CI 0.9-7.9).,"[{'ForeName': 'Zerihun', 'Initials': 'Z', 'LastName': 'Zerdo', 'Affiliation': 'Department of Medical Laboratory Science, College of Medicine and Health Sciences, Arba Minch University, Arba Minch, Ethiopia. zedozerihun@gmail.com.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Bastiaens', 'Affiliation': 'Department of Family Medicine and Population Health, Antwerp University, Antwerp, Belgium.'}, {'ForeName': 'Sibyl', 'Initials': 'S', 'LastName': 'Anthierens', 'Affiliation': 'Department of Family Medicine and Population Health, Antwerp University, Antwerp, Belgium.'}, {'ForeName': 'Fekadu', 'Initials': 'F', 'LastName': 'Massebo', 'Affiliation': 'Department of Biology, College of Natural Sciences, Arba Minch University, Arba Minch, Ethiopia.'}, {'ForeName': 'Matewos', 'Initials': 'M', 'LastName': 'Masne', 'Affiliation': 'Department of Biology, College of Natural Sciences, Arba Minch University, Arba Minch, Ethiopia.'}, {'ForeName': 'Gelila', 'Initials': 'G', 'LastName': 'Biresaw', 'Affiliation': 'Department of Medical Laboratory Science, College of Medicine and Health Sciences, Arba Minch University, Arba Minch, Ethiopia.'}, {'ForeName': 'Misgun', 'Initials': 'M', 'LastName': 'Shewangizaw', 'Affiliation': 'Department of Public Health, College of Medicine and Health Sciences, Arba Minch University, Arba Minch, Ethiopia.'}, {'ForeName': 'Abayneh', 'Initials': 'A', 'LastName': 'Tunje', 'Affiliation': 'Department of Public Health, College of Medicine and Health Sciences, Arba Minch University, Arba Minch, Ethiopia.'}, {'ForeName': 'Yilma', 'Initials': 'Y', 'LastName': 'Chisha', 'Affiliation': 'Department of Public Health, College of Medicine and Health Sciences, Arba Minch University, Arba Minch, Ethiopia.'}, {'ForeName': 'Tsegaye', 'Initials': 'T', 'LastName': 'Yohannes', 'Affiliation': 'Department of Medical Laboratory Science, College of Medicine and Health Sciences, Arba Minch University, Arba Minch, Ethiopia.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Van Geertruyden', 'Affiliation': 'Global Health Institute, Antwerp University, Antwerp, Belgium.'}]",Malaria journal,['10.1186/s12936-020-03437-9']
2834,33059679,Effect of a high value care curriculum on standardized patient exam in the Core Clerkship in Internal Medicine.,"BACKGROUND


With almost 20% unnecessary spending on healthcare, there has been increasing interest in high value care defined as the best care for the patient, with the optimal result for the circumstances, delivered at the right price. The American Association of Medical Colleges recommend that medical students are proficient in concepts of cost-effective clinical practice by graduation, thus leading to curricula on high value care. However little is published on the effectiveness of these curricula on medical students' ability to practice high value care.
METHODS


In addition to the standard curriculum, the intervention group received two classroom sessions and three virtual patients focused on the concepts of high value care. The primary outcome was number of tests and charges for tests on standardized patients.
RESULTS


136 students enrolled in the Core Clerkship in Internal Medicine and 70 completed the high value care curriculum. There were no significant differences in ordering of appropriate tests (3.1 vs. 3.2 tests/students, p = 0.55) and inappropriate tests (1.8 vs. 2.2, p = 0.13) between the intervention and control. Students in the intervention group had significantly lower median Medicare charges ($287.59 vs. $500.86, p = 0.04) and felt their education in high value care was appropriate (81% vs. 56%, p = 0.02).
CONCLUSIONS


This is the first study to describe the impact of a high value care curriculum on medical students' ordering practices. While number of inappropriate tests was not significantly different, students in the intervention group refrained from ordering expensive tests.",2020,"Students in the intervention group had significantly lower median Medicare charges ($287.59 vs. $500.86, p = 0.04) and felt their education in high value care was appropriate (81% vs. 56%, p = 0.02).
","['136 students enrolled in the Core Clerkship in Internal Medicine and 70 completed the high value care curriculum', ""medical students' ordering practices"", 'standardized patient exam in the Core Clerkship in Internal Medicine']",['high value care curriculum'],"['ordering of appropriate tests', 'inappropriate tests', 'number of tests and charges for tests on standardized patients', 'median Medicare charges']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}]",136.0,0.0265975,"Students in the intervention group had significantly lower median Medicare charges ($287.59 vs. $500.86, p = 0.04) and felt their education in high value care was appropriate (81% vs. 56%, p = 0.02).
","[{'ForeName': 'Amit K', 'Initials': 'AK', 'LastName': 'Pahwa', 'Affiliation': 'Division of Hospital Medicine, Division of General Pediatrics, Johns Hopkins University School of Medicine, 600 North Wolfe Street, Baltimore, MD, 21287, USA. pahwa@jhu.edu.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Eaton', 'Affiliation': 'Divsion of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, 600 North Wolfe Street, Harvey 806, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Ariella', 'Initials': 'A', 'LastName': 'Apfel', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, 2024 East Monument Street, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bertram', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, 601 North Caroline Street, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ridell', 'Affiliation': 'Office of Assessment and Evaluation, Johns Hopkins University School of Medicine, 2024 East Monument Street, Room 1-200, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Danelle', 'Initials': 'D', 'LastName': 'Cayea', 'Affiliation': 'Division of Geriatrics, Department of Medicine, Johns Hopkins University School of Medicine, 5200 Easter Avenue, Mason Lord Building Center Tower Suite, Baltimore, MD, 2200, USA.'}]",BMC medical education,['10.1186/s12909-020-02303-1']
2835,33059710,"Associations between Patient Global Assessment scores and pain, physical function, and fatigue in rheumatoid arthritis: a post hoc analysis of data from phase 3 trials of tofacitinib.","BACKGROUND


Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We examined the degree to which Patient Global Assessment of Disease Activity (PtGA) was driven by patient-reported assessments of pain (Pain), physical function, and fatigue in patients receiving tofacitinib 5 mg twice daily or placebo, each with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).
METHODS


This post hoc analysis used data pooled from three randomized controlled trials in csDMARD-inadequate responder (csDMARD-IR) patients (ORAL Scan: NCT00847613; ORAL Standard: NCT00853385; ORAL Sync: NCT00856544). Using subgroup analysis from 2 × 2 tables, associations between PtGA and Pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at month 3 were evaluated using Pearson's Phi correlation coefficients. To support the main analysis, associations between select patient-reported outcomes (PROs) were also evaluated in csDMARD-naïve (ORAL Start; NCT01039688) and biologic (b)DMARD-IR (ORAL Step; NCT00960440) patients.
RESULTS


Across csDMARD-IR treatment groups, low disease activity (defined as PtGA ≤ 20 mm), and moderate (≥ 30%) and substantial (≥ 50%) improvements from baseline in PtGA were associated with mild Pain (Visual Analog Scale score ≤ 20 mm), and moderate (≥ 30%) and substantial (≥ 50%) improvements from baseline in Pain; lack of Pain improvement was associated with little/no improvement in PtGA. In contrast, large proportions of csDMARD-IR patients who reported PtGA improvements did not report HAQ-DI or FACIT-F scores ≥ normative values (≤ 0.25 and ≥ 43.5, respectively) or changes in HAQ-DI or FACIT-F scores ≥ minimum clinically important difference (≥ 0.22 and ≥ 4.0, respectively). Generally, PtGA and Pain outcomes were moderately-to-strongly correlated at month 3 in csDMARD-IR patients, with weaker correlations evident between PtGA and HAQ-DI/FACIT-F outcomes. Similar findings were generally evident in csDMARD-naïve and bDMARD-IR patients.
CONCLUSIONS


This analysis supports the role of Pain as a key driver of PtGA in RA; physical function and fatigue play lesser roles in patients' perceptions of disease activity. These findings corroborate the importance of improved PROs and attainment of low symptom states for optimizing patient care.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT00847613 (registered: February 19, 2009); NCT00853385 (registered: March 2, 2009); NCT00856544 (registered: March 5, 2009); NCT01039688 (registered: December 25, 2009); NCT00960440 (registered: August 17, 2009).",2020,"Generally, PtGA and Pain outcomes were moderately-to-strongly correlated at month 3 in csDMARD-IR patients, with weaker correlations evident between PtGA and HAQ-DI/FACIT-F outcomes.",[],"['tofacitinib', 'tofacitinib 5\u2009mg twice daily or placebo, each with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs']","['pain, physical function, and fatigue in rheumatoid arthritis', 'mild Pain (Visual Analog Scale score', 'PtGA and Pain outcomes', 'HAQ-DI or FACIT-F scores', 'low disease activity', 'PtGA', 'Pain; lack of Pain improvement', 'pain (Pain), physical function, and fatigue', 'PtGA and Pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and Functional Assessment of Chronic Illness Therapy-Fatigue', 'HAQ-DI or FACIT-F scores ≥\u2009normative values']",[],"[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C3505040', 'cui_str': 'tofacitinib 5 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0278138', 'cui_str': 'Mild pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.143685,"Generally, PtGA and Pain outcomes were moderately-to-strongly correlated at month 3 in csDMARD-IR patients, with weaker correlations evident between PtGA and HAQ-DI/FACIT-F outcomes.","[{'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kaine', 'Affiliation': 'Independent Healthcare Associates Inc, Cullowhee, NC, USA.'}, {'ForeName': 'Rieke', 'Initials': 'R', 'LastName': 'Alten', 'Affiliation': 'Schlosspark-Klinik, University Medicine, Berlin, Germany.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Wallenstein', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Diehl', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Germino', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Murray', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA. Christopher.W.Murray@pfizer.com.'}]",Arthritis research & therapy,['10.1186/s13075-020-02324-7']
2836,33059763,Does a video clip enhance recruitment into a parenting trial? Learnings from a study within a trial.,"BACKGROUND


Reaching recruitment targets in randomised controlled trials is a challenge. Media tools are increasingly used to engage participants, yet there is a paucity of research into the use of video to optimise recruitment. We therefore tested whether adding a participant information video clip to a standard participant information sheet improved recruitment into a parenting trial.
METHODS


One hundred seven participants were randomised to receive either a participant information sheet (n = 51) or an informational video clip (n = 56) as part of an email contact following a screening phase. All participants went on to receive the information sheet as part of the existing consent procedure.
RESULTS


The video condition did not increase the odds of recruitment into the trial, such that those in the video condition were significantly less likely to participate in the main trial (OR = 0.253, CI = 0.104-0.618, p = 0.003).
CONCLUSION


The introduction of a video clip into the recruitment stages of a parenting trial did not lead to an improvement in recruitment; however, the small sample size precludes definitive inferences. We offer reflections on challenges encountered in implementing the SWAT and suggestions for other researchers seeking to embed recruitment SWATs into similar trials.
TRIAL REGISTRATION


Current controlled trials ISRCTN 58327365 . Registered on 19 March 2015.
SWAT REGISTRATION


SWAT 106; Effects of a video clip on recruitment into a randomised trial. Registered on 20 December 2016.",2020,One hundred seven participants were randomised to receive either a participant information sheet (n = 51) or an informational video clip (n = 56) as part of an email contact following a screening phase.,['One hundred seven participants'],"['video clip', 'participant information sheet (n\u2009=\u200951) or an informational video clip']",[],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}]",[],107.0,0.358289,One hundred seven participants were randomised to receive either a participant information sheet (n = 51) or an informational video clip (n = 56) as part of an email contact following a screening phase.,"[{'ForeName': 'Holly C', 'Initials': 'HC', 'LastName': 'Mattock', 'Affiliation': 'Centre for Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Ryan', 'Affiliation': 'Centre for Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': ""O'Farrelly"", 'Affiliation': 'Centre for Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Babalis', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Ramchandani', 'Affiliation': 'Centre for Psychiatry, Imperial College London, London, UK. pr441@cam.ac.uk.'}]",Trials,['10.1186/s13063-020-04779-0']
2837,33059765,Short-term fasting accompanying chemotherapy as a supportive therapy in gynecological cancer: protocol for a multicenter randomized controlled clinical trial.,"BACKGROUND/OBJECTIVES


A few preliminary studies have documented the safety and feasibility of repeated short-term fasting in patients undergoing chemotherapy. However, there is a lack of data from larger randomized trials on the effects of short-term fasting on quality of life, reduction of side effects during chemotherapy, and a possible reduction of tumor progression. Moreover, no data is available on the effectiveness of fasting approaches compared to so-called healthy diets. We aim to investigate whether the potentially beneficial effects of short-term fasting can be confirmed in a larger randomized trial and can compare favorably to a plant-based wholefood diet.
METHODS


This is a multicenter, randomized, controlled, two-armed interventional study with a parallel group assignment. One hundred fifty patients, including 120 breast cancer patients and 30 patients with ovarian cancer, are to be randomized to one of two nutritional interventions accompanying chemotherapy: (1) repeated short-term fasting with a maximum energy supply of 350-400 kcal on fasting days or (2) repeated short-term normocaloric plant-based diet with restriction of refined carbohydrates. The primary outcome is disease-related quality of life, as assessed by the functional assessment of the chronic illness therapy measurement system. Secondary outcomes include changes in the Hospital Anxiety and Depression Score and as well as frequency and severity of chemotherapy-induced side effects based on the Common Terminology Criteria of Adverse Events. Explorative analysis in a subpopulation will compare histological complete remissions in patients with neoadjuvant treatments.
DISCUSSION/PLANNED OUTCOMES


Preclinical data and a small number of clinical studies suggest that repeated short-term fasting may reduce the side effects of chemotherapy, enhance quality of life, and eventually slow down tumor progression. Experimental research suggests that the effects of fasting may partly be caused by the restriction of animal protein and refined carbohydrates. This study is the first confirmatory, randomized controlled, clinical study, comparing the effects of short-term fasting to a short-term, plant-based, low-sugar diet during chemotherapy on quality of life and histological tumor remission.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03162289 . Registered on 22 May 2017.",2020,"The primary outcome is disease-related quality of life, as assessed by the functional assessment of the chronic illness therapy measurement system.","['patients undergoing chemotherapy', 'One hundred fifty patients, including 120 breast cancer patients and 30 patients with ovarian cancer', 'patients with neoadjuvant treatments', 'gynecological cancer']","['short-term fasting to a short-term, plant-based, low-sugar diet during chemotherapy', 'Short-term fasting accompanying chemotherapy', 'plant-based wholefood diet', 'nutritional interventions accompanying chemotherapy: (1) repeated short-term fasting with a maximum energy supply of 350-400\u2009kcal on fasting days or (2) repeated short-term normocaloric plant-based diet with restriction of refined carbohydrates']","['Hospital Anxiety and Depression Score and as well as frequency and severity of chemotherapy-induced side effects based on the Common Terminology Criteria of Adverse Events', 'disease-related quality of life, as assessed by the functional assessment of the chronic illness therapy measurement system', 'histological complete remissions', 'quality of life, reduction of side effects', 'quality of life and histological tumor remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452316', 'cui_str': 'Low sugar diet'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C5197846', 'cui_str': 'Diet, Plant-Based'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0175898', 'cui_str': 'Refined carbohydrate'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0028275', 'cui_str': 'Terminology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.0886616,"The primary outcome is disease-related quality of life, as assessed by the functional assessment of the chronic illness therapy measurement system.","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Koppold-Liebscher', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany. daniela.liebscher@charite.de.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Kessler', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Steckhan', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Bähr', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Kempter', 'Affiliation': 'Department of Gynecology, Waldfriede Hospital, Berlin, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Wischnewsky', 'Affiliation': 'Department of Mathematics and Computer Science, University of Bremen, Bremen, Germany.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Hübner', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kunz', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Paul', 'Affiliation': 'Vivantes Hospital Breast Centre, Berlin, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Zorn', 'Affiliation': 'Department of Medicine I, Section of Clinical Nutrition and Dietetics, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Sari', 'Affiliation': 'Department of Nutrition, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jeitler', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Stange', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Michalsen', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}]",Trials,['10.1186/s13063-020-04700-9']
2838,33059771,"Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES


To evaluate the efficacy of two doses of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac in symptomatic individuals, with virological confirmation of COVID-19, two weeks after the completion of the two-dose vaccination regimen, aged 18 years or older who work as health professionals providing care to patients with possible or confirmed COVID-19. To describe the occurrence of adverse reactions associated with the administration of each of two doses of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac up to one week after vaccination in Adults (18-59 years of age) and Elderly (60 years of age or more).
TRIAL DESIGN


This is a Phase III, randomized, multicenter, endpoint driven, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac. The adsorbed vaccine COVID-19 (inactivated) produced by Sinovac (product under investigation) will be compared to placebo. Voluntary participants will be randomized to receive two intramuscular doses of the investigational product or the placebo, in a 1: 1 ratio, stratified by age group (18 to 59 years and 60 years or more) and will be monitored for one year by active surveillance of COVID-19. Two databases will be established according to the age groups: one for adults (18-59 years) and one for the elderly (60 years of age or older). The threshold to consider the vaccine efficacious will be to reach a protection level of at least 50%, as proposed by the World Health Organization and the FDA. Success in this criterion will be defined by sequential monitoring with adjustment of the lower limit of the 95% confidence interval above 30% for the primary efficacy endpoint.
PARTICIPANTS


Healthy participants and / or participants with clinically controlled disease, of both genders, 18 years of age or older, working as health professionals performing care in units specialized in direct contact with people with possible or confirmed cases of COVID-19. Participation of pregnant women and those who are breastfeeding, as well as those intending to become pregnant within three months after vaccination will not be allowed. Participants will only be included after signing the voluntary Informed Consent Form and ensuring they undergo screening evaluation and conform to all the inclusion and exclusion criteria. All the clinical sites are located in Brazil.
INTERVENTION AND COMPARATOR


Experimental intervention: The vaccine was manufactured by Sinovac Life Sciences (Beijing, China) and contains 3 μg/0.5 mL (equivalent to 600 SU per dose) of inactivated SARS-CoV-2 virus, and aluminium hydroxide as adjuvant. Control comparator: The placebo contains aluminium hydroxide in a 0.5 mL solution The schedule of both, experimental intervention and placebo is two 0.5 mL doses IM (deltoid) with a two week interval.
MAIN OUTCOMES


The primary efficacy endpoint is the incidence of symptomatic cases of virologically confirmed COVID-19 two weeks after the second vaccination. The virological diagnosis will be confirmed by detection of SARS-CoV-2 nucleic acid in a clinical sample. The primary safety endpoint is the frequency of solicited and unsolicited local and systemic adverse reactions during the period of one week after vaccination according to age group in adult (18-59 years old) and elder (60 years of age or older) subjects. Adverse reactions are defined as adverse events that have a reasonable causal relationship to vaccination.
RANDOMISATION


There will be two randomization lists, one for each age group, based on the investigational products to be administered, i.e., vaccine or placebo at a 1: 1 ratio. Each randomization list will be made to include up to 11,800 (18-59 year-old) adults, and 1,260 elderly (60 y-o and older) participants, the maximum number of participants needed per age group. An electronic central randomization system will be used to designate the investigational product that each participant must receive.
BLINDING (MASKING)


This trial is designed as a double-blind study to avoid introducing bias in the evaluation of efficacy, safety and immunogenicity. The clinical care team, the professionals responsible for the vaccination and the participants will not know which investigational product will be administered. Only pharmacists or nurses in the study who are responsible for the randomization, separation and blinding of the investigational product will have access to unblinded information. The sponsor's operational team will also remain blind.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The total number of participants needed to evaluate efficacy, 13,060 participants, satisfies the needed sample size calculated to evaluate safety. Therefore, the total number obtained for efficacy will be the number retained for the study. Up to 13,060 participants are expected to enter the study, with up to 11,800 participants aged 18 to 59 years and 1,260 elderly participants aged 60 and over. Half of the participants of each group will receive the experimental vaccine and half of them will receive the placebo. The recruitment of participants may be modified as recommended by the Data Safety Monitoring Committee at time of the interim unblinded analysis or blind assessment of the COVID-19 attack rate during the study.
TRIAL STATUS


Protocol version 2.0 - 24-Aug-2020. Recruitment started on July 21 st , 2020. The recruitment is expected to conclude in October 2020.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT0445659 . Registry on 2 July 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,The primary safety endpoint is the frequency of solicited and unsolicited local and systemic adverse reactions during the period of one week after vaccination according to age group in adult (18-59 years old) and elder (60 years of age or older) subjects.,"['symptomatic individuals, with virological confirmation of COVID-19, two weeks after the completion of the two-dose vaccination regimen, aged 18 years or older who work as health professionals providing care to patients with possible or confirmed COVID-19', 'pregnant women', 'Healthy participants and / or participants with clinically controlled disease, of both genders, 18 years of age or older, working as health professionals performing care in units specialized in direct contact with people with possible or confirmed cases of COVID-19', 'Registry on 2 July 2020', 'age groups: one for adults (18-59 years) and one for the elderly (60 years of age or older', 'in Adults (18-59 years of age) and Elderly (60 years of age or more', '11,800 (18-59 year-old) adults, and 1,260 elderly (60 y-o and older) participants, the maximum number of participants needed per age group', '13,060 participants are expected to enter the study, with up to 11,800 participants aged 18 to 59 years and 1,260 elderly participants aged 60 and over', 'Voluntary participants']","['adsorbed vaccine COVID-19 (inactivated) produced by Sinovac up to one week after vaccination', 'adsorbed vaccine COVID-19 (inactivated) produced by Sinovac', 'placebo contains aluminium hydroxide', 'vaccine or placebo', 'vaccine was manufactured by Sinovac Life Sciences (Beijing, China) and contains 3 μg/0.5 mL (equivalent to 600 SU per dose) of inactivated SARS-CoV-2 virus, and aluminium hydroxide', 'placebo', 'adsorbed vaccine COVID-19 (inactivated', 'Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV', 'Placebo']","['frequency of solicited and unsolicited local and systemic adverse reactions', 'efficacy, safety and immunogenicity', 'efficacy and safety', 'Efficacy and Safety', 'incidence of symptomatic cases']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0005526', 'cui_str': 'Biological Sciences'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",2.0,0.413425,The primary safety endpoint is the frequency of solicited and unsolicited local and systemic adverse reactions during the period of one week after vaccination according to age group in adult (18-59 years old) and elder (60 years of age or older) subjects.,"[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Palacios', 'Affiliation': 'Center for Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil. ricardo.palacios@butantan.gov.br.'}, {'ForeName': 'Elizabeth González', 'Initials': 'EG', 'LastName': 'Patiño', 'Affiliation': 'Center for Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'de Oliveira Piorelli', 'Affiliation': 'Center for Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Monica Tilli Reis Pessoa', 'Initials': 'MTRP', 'LastName': 'Conde', 'Affiliation': 'Center for Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Batista', 'Affiliation': 'Center for Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Sinovac Life Sciences, Beijing, China.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Xin', 'Affiliation': 'Sinovac Life Sciences, Beijing, China.'}, {'ForeName': 'Esper G', 'Initials': 'EG', 'LastName': 'Kallas', 'Affiliation': 'Department of Infectious and Parasitic Diseases, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Flores', 'Affiliation': 'PATH US, Washington DC, USA.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Ockenhouse', 'Affiliation': 'PATH US, Washington DC, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gast', 'Affiliation': 'PATH, Seattle, WA, USA.'}]",Trials,['10.1186/s13063-020-04775-4']
2839,33059798,Health Promotion Programs and Policies in the Workplace: An Exploratory Study With Alaska Businesses.,"INTRODUCTION


We examined health insurance benefits, workplace policies, and health promotion programs in small to midsize businesses in Alaska whose workforces were at least 20% Alaska Native. Participating businesses were enrolled in a randomized trial to improve health promotion efforts.
METHODS


Twenty-six Alaska businesses completed from January 2009 through October 2010 a 30-item survey on health benefits, policies, and programs in the workplace. We generated frequency statistics to describe overall insurance coverage, and to detail insurance coverage, company policies, and workplace programs in 3 domains: tobacco use, physical activity and nutrition, and disease screening and management.
RESULTS


Businesses varied in the number of employees (mean, 250; median, 121; range, 41-1,200). Most businesses offered at least partial health insurance for full-time employees and their dependents. Businesses completely banned tobacco in the workplace, and insurance coverage for tobacco cessation was limited. Eighteen had onsite food vendors, yet fewer than 6 businesses offered healthy food options, and even fewer offered them at competitive prices. Cancer screening and treatment were the health benefits most commonly covered by insurance.
CONCLUSION


Although insurance coverage and workplace policies for chronic disease screening and management were widely available, significant opportunities remain for Alaska businesses to collaborate with federal, state, and community organizations on health promotion efforts to reduce the risk of chronic illness among their employees.",2020,"RESULTS


Businesses varied in the number of employees (mean, 250; median, 121; range, 41-1,200).","['Workplace', 'Twenty-six Alaska businesses completed from January 2009 through October 2010 a 30-item survey on health benefits, policies, and programs in the workplace']",[],[],"[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0001905', 'cui_str': 'Alaska'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],[],,0.0267488,"RESULTS


Businesses varied in the number of employees (mean, 250; median, 121; range, 41-1,200).","[{'ForeName': 'Craig N', 'Initials': 'CN', 'LastName': 'Sawchuk', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, 200 First St SW, Rochester, MN 55905. Email: sawchuk.craig@mayo.edu.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Russo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, Washington.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Ferguson', 'Affiliation': 'University of Alaska, Anchorage, Alaska.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Williamson', 'Affiliation': 'Alaska Native Tribal Health Consortium, Anchorage, Alaska.'}, {'ForeName': 'Janice A', 'Initials': 'JA', 'LastName': 'Sabin', 'Affiliation': 'Department of Biomedical Informatics and Medical Education, University of Washington, Seattle, Washington.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Goldberg', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Madesclaire', 'Affiliation': 'Institute for Research and Education, Washington State University, Spokane, Washington.'}, {'ForeName': 'Olivia E', 'Initials': 'OE', 'LastName': 'Bogucki', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Dedra', 'Initials': 'D', 'LastName': 'Buchwald', 'Affiliation': 'Institute for Research and Education, Washington State University, Spokane, Washington.'}]",Preventing chronic disease,['10.5888/pcd17.200111']
2840,33059801,[A comparative analysis of the efficacy of two vitamin D supplementation regimens in preterm infants: a prospective randomized controlled study].,"OBJECTIVE


To study the effect of different vitamin D supplementation regimens on the nutritional status of vitamin D on day 28 after birth in preterm infants with a gestational age of <34 weeks.
METHODS


A total of 59 preterm infants with a gestational age of <34 weeks who were born from October 2018 to October 2019 were enrolled and divided into an observation group with 30 infants and a control group with 29 infants. The infants in the observation group received a single-dose intramuscular injection of vitamin D 3  (10 000 IU/kg), while those in the control group received oral vitamin D 3  drops (900 IU/d) for 25 days. Venous blood samples were collected within 48 hours after birth (before vitamin D 3  supplementation) and on day 28 after birth to measure the serum 25-hydroxyvitamin D [25(OH)D] level.
RESULTS


Within 48 hours after birth, the prevalence rate of vitamin D deficiency (≤15 ng/mL) was 78% among the 59 preterm infants. There were no significant differences in the serum 25(OH)D level and the prevalence rate of vitamin D deficiency between the two groups (P>0.05). Compared with the control group on day 28 after birth, the observation group had a significantly higher serum 25(OH)D level (P<0.05) and a significantly lower prevalence rate of vitamin D deficiency (P<0.05). There were no cases of vitamin D overdose or poisoning.
CONCLUSIONS


In preterm infants with a gestational age of <34 weeks, single-dose intramuscular injection of 10 000 IU/kg vitamin D 3  can significantly increase serum 25(OH)D level on day 28 after birth and safely and effectively reduce the prevalence rate of vitamin D deficiency.",2020,There were no significant differences in the serum 25(OH)D level and the prevalence rate of vitamin D deficiency between the two groups (P>0.05).,"['preterm infants', 'day 28 after birth in preterm infants with a gestational age of <34 weeks', '59 preterm infants', '59 preterm infants with a gestational age of <34 weeks who were born from October 2018 to October 2019 were enrolled and divided into an observation group with 30 infants and a control group with 29 infants', 'preterm infants with a gestational age of <34 weeks']","['oral vitamin D 3  drops', 'single-dose intramuscular injection of vitamin D', 'vitamin D supplementation regimens']","['serum 25-hydroxyvitamin D [25(OH)D] level', 'nutritional status of vitamin D', 'Venous blood samples', 'prevalence rate of vitamin D deficiency', 'serum 25(OH)D level and the prevalence rate of vitamin D deficiency', 'serum 25(OH)D level', 'vitamin D overdose or poisoning']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0573817', 'cui_str': 'Vitamin D overdose'}, {'cui': 'C0032343', 'cui_str': 'Poisoning'}]",59.0,0.0793967,There were no significant differences in the serum 25(OH)D level and the prevalence rate of vitamin D deficiency between the two groups (P>0.05).,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': ""Department of Neonatology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China. zhouxih@mail.xjtu.edu.cn.""}, {'ForeName': 'Li-Meng', 'Initials': 'LM', 'LastName': 'Geng', 'Affiliation': ''}, {'ForeName': 'Xi-Hui', 'Initials': 'XH', 'LastName': 'Zhou', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[]
2841,33060078,Cost-effectiveness of internet-based vestibular rehabilitation with and without physiotherapy support for adults aged 50 and older with a chronic vestibular syndrome in general practice.,"OBJECTIVES


To evaluate the cost-effectiveness of stand-alone and blended internet-based vestibular rehabilitation (VR) in comparison with usual care (UC) for chronic vestibular syndromes in general practice.
DESIGN


Economic evaluation alongside a three-armed, individually randomised controlled trial.
SETTING


59 Dutch general practices.
PARTICIPANTS


322 adults, aged 50 years and older with a chronic vestibular syndrome.
INTERVENTIONS


Stand-alone VR consisted of a 6-week, internet-based intervention with weekly online sessions and daily exercises. In blended VR, this intervention was supplemented with face-to-face physiotherapy support. UC group participants received usual general practice care without restrictions.
MAIN OUTCOME MEASURES


Societal costs, quality-adjusted life years (QALYs), Vertigo Symptom Scale-Short Form (VSS-SF), clinically relevant response (≥3 points VSS-SF improvement).
RESULTS


Mean societal costs in both the stand-alone and blended VR groups were statistically non-significantly higher than in the UC group (mean difference (MD) €504, 95% CI -1082 to 2268; and €916, 95% CI -663 to 2596). Both stand-alone and blended VR groups reported non-significantly more QALYs than the UC group (MD 0.02, 95% CI -0.00 to 0.04; and 0.01, 95% CI -0.01 to 0.03), and significantly better VSS-SF Scores (MD 3.8 points, 95% CI 1.7 to 6.0; and 3.3 points, 95% CI 1.3 to 5.2). For stand-alone VR compared with UC, the probability of cost-effectiveness was 0.95 at a willingness-to-pay ratio of €24 161/QALY, €600/point improvement in VSS-SF and €8000/clinically relevant responder in VSS-SF. For blended VR versus UC, the probability of cost-effectiveness was 0.95 at a willingness-to-pay ratio of €123 335/QALY, €900/point improvement in VSS-SF and €24 000/clinically relevant responder in VSS-SF.
CONCLUSION


Stand-alone and blended internet-based VR non-significantly increased QALYs and significantly reduced vestibular symptoms compared with UC, while costs in both groups were non-significantly higher. Stand-alone VR has the highest probability to be cost-effective compared with UC.
TRIAL REGISTRATION NUMBER


The Netherlands Trial Register NTR5712.",2020,"Mean societal costs in both the stand-alone and blended VR groups were statistically non-significantly higher than in the UC group (mean difference (MD) €504, 95% CI -1082 to 2268; and €916, 95% CI -663 to 2596).","['322 adults, aged 50 years and older with a chronic vestibular syndrome', '59 Dutch general practices', 'adults aged 50 and older with a chronic vestibular syndrome in general practice']","['usual general practice care without restrictions', 'UC', 'internet-based vestibular rehabilitation with and without physiotherapy support', 'stand-alone and blended internet-based vestibular rehabilitation (VR', 'Stand-alone VR consisted of a 6-week, internet-based intervention with weekly online sessions and daily exercises', 'usual care (UC']","['probability of cost-effectiveness', 'Societal costs, quality-adjusted life years (QALYs), Vertigo Symptom Scale-Short Form (VSS-SF), clinically relevant response (≥3 points VSS-SF improvement', 'Cost-effectiveness', 'VSS-SF Scores', 'vestibular symptoms', 'Mean societal costs']","[{'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}]","[{'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",322.0,0.114926,"Mean societal costs in both the stand-alone and blended VR groups were statistically non-significantly higher than in the UC group (mean difference (MD) €504, 95% CI -1082 to 2268; and €916, 95% CI -663 to 2596).","[{'ForeName': 'Vincent A', 'Initials': 'VA', 'LastName': 'van Vugt', 'Affiliation': 'Department of General Practice, Amsterdam UMC - Location VUMC, Amsterdam, The Netherlands v.vanvugt@amsterdamumc.nl.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Aureliano P', 'Initials': 'AP', 'LastName': 'Finch', 'Affiliation': 'Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'van der Wouden', 'Affiliation': 'Department of General Practice, Amsterdam UMC - Location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Henriëtte E', 'Initials': 'HE', 'LastName': 'van der Horst', 'Affiliation': 'Department of General Practice, Amsterdam UMC - Location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Otto R', 'Initials': 'OR', 'LastName': 'Maarsingh', 'Affiliation': 'Department of General Practice, Amsterdam UMC - Location VUMC, Amsterdam, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-035583']
2842,33060086,Couples-based approach to HIV prevention for transgender women and their partners: study protocol for a randomised controlled trial testing the efficacy of the 'It Takes Two' intervention.,"INTRODUCTION


HIV transmission and acquisition risk among transgender women is particularly high in the context of primary partnerships. This project extends a previous pilot couples-focused HIV intervention programme, which was shown to be feasible, acceptable and promising in reducing sexual risk behaviour among transgender women and their partners. This randomised controlled trial (RCT) tests the efficacy of this culturally sensitive HIV prevention programme for HIV-serodiscordant and HIV-negative seroconcordant transgender women and their partners.
METHODS AND ANALYSIS


To finalise the protocol for trial, we used qualitative methods to hone eligibility criteria, refine the intervention and control manuals, and name and brand the intervention ('It Takes Two'). The RCT investigates the effects of the It Takes Two intervention on Composite Risk for HIV (CR-HIV) among 100 couples. CR-HIV is a binary indicator of couple HIV risk using validated measures of sexual behaviour, pre-exposure prophylaxis use among HIV-negative participants and viral suppression among participants living with HIV. Using a two-arm RCT, we will examine intervention effects on CR-HIV at 12-month follow-up comparing transgender women and their partners randomised to the intervention versus control (HIV prevention information only).
ETHICS AND DISSEMINATION


This study has been reviewed and approved by the University of California, San Francisco (19-28624) and the University of Michigan (HUM00147690) Institutional Review Boards. Participants provide informed consent before taking part of the study activities. Results will be published in peer-reviewed journals and presented at scientific conferences. We will make our results available to the community of researchers and general public interested in transgender health to avoid unintentional duplication of research, as well as to others in the health and social services community, including LGBT community-based organisations, AIDS service organisations and other transgender-serving organisations. The full de-identified dataset and codebook will be shared at the University of Michigan Digital Repository.
TRIAL REGISTRATION NUMBER


NCT04067661.",2020,"This randomised controlled trial (RCT) tests the efficacy of this culturally sensitive HIV prevention programme for HIV-serodiscordant and HIV-negative seroconcordant transgender women and their partners.
","['HIV-serodiscordant and HIV-negative seroconcordant transgender women and their partners', 'participants living with HIV', 'University of California, San Francisco (19-28624) and the University of Michigan (HUM00147690) Institutional Review Boards', 'transgender women and their partners', '100 couples']","['culturally sensitive HIV prevention programme', 'intervention versus control (HIV prevention information only']",['sexual risk behaviour'],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0689383,"This randomised controlled trial (RCT) tests the efficacy of this culturally sensitive HIV prevention programme for HIV-serodiscordant and HIV-negative seroconcordant transgender women and their partners.
","[{'ForeName': 'Kristi E', 'Initials': 'KE', 'LastName': 'Gamarel', 'Affiliation': 'Department of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Jae M', 'Initials': 'JM', 'LastName': 'Sevelius', 'Affiliation': 'Center for AIDS Prevention Studies, University of California, San Francisco, California, USA.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Center for AIDS Prevention Studies, University of California, San Francisco, California, USA.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Kaplan', 'Affiliation': 'Department of Obstetrics, Gynecology, & Reproductive Sciences, University of California, San Francisco, California, USA.'}, {'ForeName': 'Mallory O', 'Initials': 'MO', 'LastName': 'Johnson', 'Affiliation': 'Center for AIDS Prevention Studies, University of California, San Francisco, California, USA.'}, {'ForeName': 'Tooru', 'Initials': 'T', 'LastName': 'Nemoto', 'Affiliation': 'Public Health Institute, Oakland, California, USA.'}, {'ForeName': 'Lynae A', 'Initials': 'LA', 'LastName': 'Darbes', 'Affiliation': 'Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Operario', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, USA Don_Operario@brown.edu.'}]",BMJ open,['10.1136/bmjopen-2020-038723']
2843,33060088,Ghost ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer (DRKS00013997): protocol for a randomised controlled trial.,"INTRODUCTION


Anastomotic leakage is the most important complication in colorectal surgery occurring in up to 20% after low anterior rectal resection. Therefore, a diverting ileostomy is usually created during low anterior resection to protect the anastomosis or rather to diminish the consequences in case of anastomotic leakage. The so-called virtual or ghost ileostomy is a pre-stage ostomy that can be easily exteriorised, if anastomotic leakage is suspected, in order to avoid the severe consequences of anastomotic leakage. On the other hand, an actual ileostomy can be avoided in patients, who do not develop anastomotic leakage.
METHODS AND ANALYSIS


The GHOST trial is a randomised controlled pilot trial comparing ghost ileostomy with conventional loop ileostomy in patients undergoing low anterior resection with total mesorectal excision for rectal cancer. After screening for eligibility and obtaining informed consent, a total of 60 adult patients are included in the trial. Patients are intraoperatively randomised to the trial groups in a 1:1 ratio after assuring that none of the intraoperative exclusion criteria are present. The main outcome parameter is the comprehensive complication index as a measure of safety. Further outcomes include specific complications, stoma-related complications, complications of ileostomy closure, frequency of transformation of ghost ileostomy into conventional ileostomy, frequency of terminal ostomy creation, proportion of patients with an ostomy at 6 months after index surgery, anorectal function (Wexner score) and quality of life assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and CR29 questionnaires. Follow-up for each individual patient will be 6 months.
ETHICS AND DISSEMINATION


The GHOST trial has been approved by the Medical Ethics Committee of Heidelberg University (reference number S-694/2017). If the intervention proves to be safe, loop ileostomy could be spared in a large proportion of patients, thus also avoiding stoma-related complications and a second operation (ileostomy closure) with its inherent complications in these patients.
TRIAL REGISTRATION NUMBER


German Clinical Trials Registry (DRKS00013997); Universal Trial Number: U1111-1208-9742.",2020,The GHOST trial is a randomised controlled pilot trial comparing ghost ileostomy with conventional loop ileostomy in patients undergoing low anterior resection with total mesorectal excision for rectal cancer.,"['patients undergoing low anterior resection with total mesorectal excision for rectal cancer', '60 adult patients are included in the trial', 'patients undergoing low anterior resection for rectal cancer']","['Ghost ileostomy versus conventional loop ileostomy', 'ileostomy with conventional loop ileostomy']","['specific complications, stoma-related complications, complications of ileostomy closure, frequency of transformation of ghost ileostomy into conventional ileostomy, frequency of terminal ostomy creation, proportion of patients with an ostomy at 6 months after index surgery, anorectal function (Wexner score) and quality of life assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and CR29 questionnaires', 'comprehensive complication index as a measure of safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442000', 'cui_str': 'Lower anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0014776', 'cui_str': 'Erythrocyte Ghost'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023985', 'cui_str': 'Creation of continent ileostomy'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0192775', 'cui_str': 'Closure of ileostomy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0014776', 'cui_str': 'Erythrocyte Ghost'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0029473', 'cui_str': 'Construction of stoma'}, {'cui': 'C0441513', 'cui_str': 'Construction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.19472,The GHOST trial is a randomised controlled pilot trial comparing ghost ileostomy with conventional loop ileostomy in patients undergoing low anterior resection with total mesorectal excision for rectal cancer.,"[{'ForeName': 'Felix J', 'Initials': 'FJ', 'LastName': 'Hüttner', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Probst', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Mihaljevic', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Contin', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'Dörr-Harim', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Ulrich', 'Affiliation': 'Surgical Department I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany markus.buechler@med.uni-heidelberg.de.'}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Knebel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-038930']
2844,33060089,"Protocol description of the HOVON 141/VISION trial: a prospective, multicentre, randomised phase II trial of ibrutinib plus venetoclax in patients with creatinine clearance ≥30 mL/min who have relapsed or refractory chronic lymphocytic leukaemia (RR-CLL) with or without TP53 aberrations.","INTRODUCTION


Literature is scarce on the combination treatment of ibrutinib and venetoclax (IV) is scarce in relapsed or refractory chronic lymphocytic leukaemia (RR-CLL). Especially, the possibility of stopping ibrutinib in RR-CLL patients in deep remission is unclear.
METHODS AND ANALYSIS


In the HOVON 141/VISION trial, patients with RR-CLL are treated with 12 cycles of IV after a short induction with ibrutinib. Patients reaching undetectable minimal residual disease (uMRD) after 12 cycles of IV are randomised 1:2 to continue ibrutinib or stop treatment. The persistence of uMRD after stopping IV is studied. In addition, in patients who become positive for MRD again after stopping, IV treatment is reinitiated. The efficacy of this approach with regard to progression-free survival 12 months after randomisation is the primary endpoint of the study.
ETHICS AND DISSEMINATION


This protocol respects the Helsinki declaration and has been approved by the ethical committee of the Amsterdam Medical Center. Study findings will be disseminated through peer-reviewed papers. All patients who fulfil the inclusion criteria and no-exclusion criteria, and have signed the informed consent form are included in the study.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03226301).",2020,"The efficacy of this approach with regard to progression-free survival 12 months after randomisation is the primary endpoint of the study.
","['All patients who fulfil the inclusion criteria and no-exclusion criteria, and have signed the informed consent form are included in the study', 'patients with creatinine clearance ≥30 mL/min who have relapsed or refractory chronic lymphocytic leukaemia (RR-CLL) with or without TP53 aberrations', 'relapsed or refractory chronic lymphocytic leukaemia (RR-CLL']",['ibrutinib plus venetoclax'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}]","[{'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}]",[],,0.197897,"The efficacy of this approach with regard to progression-free survival 12 months after randomisation is the primary endpoint of the study.
","[{'ForeName': 'Mark-David', 'Initials': 'MD', 'LastName': 'Levin', 'Affiliation': 'Department of Internal Medicine, Albert Schweitzer Hospital Location Dordwijk, Dordrecht, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Arnon', 'Initials': 'A', 'LastName': 'Kater', 'Affiliation': 'Department of Hematology, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, The Netherlands a.p.kater@amsterdamumc.nl.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Mattsson', 'Affiliation': 'Department of Hematology, Uppsala Universitet, Uppsala, Sweden.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Kersting', 'Affiliation': 'Department of Hematology, Haga Hospital, Den Haag, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Ranti', 'Affiliation': 'Department of Hematology, University of Turku, Turku, Finland.'}, {'ForeName': 'Hoa', 'Initials': 'H', 'LastName': 'Thi Tuyet Tran', 'Affiliation': 'Department of Hematology, Akershus University Hospital, Lorenskog, Norway.'}, {'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Nasserinejad', 'Affiliation': 'HOVON Data Center, Department of Hematology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Carsten Utoft', 'Initials': 'CU', 'LastName': 'Niemann', 'Affiliation': 'Department of Hematology, Rigshospitalet, Copenhagen, Denmark.'}]",BMJ open,['10.1136/bmjopen-2020-039168']
2845,33058773,Photobiomodulation Enhances the Healing of Postextraction Alveolar Sockets: A Randomized Clinical Trial With Histomorphometric Analysis and Immunohistochemistry.,"PURPOSE


Wound healing of postextraction sockets is a complex process that permits to reach the bone reformation in about three months, and that could be characterized by the presence of some complications, mainly dependent on the duration of the surgery. The aim of this study is to evaluate the impact of photobiomodulation (PBMT) on the healing processes of mucosa overlying postextraction alveolus and on related complications.
METHODS


Twenty systemically healthy patients who needed to extract both lower third molars were selected in a private clinic and included in this prospective split-mouth randomized clinical trial. Inclusion criteria were no smokers subjects with the necessity to extract both lower third molars with surgeries overlapping for duration and difficulty. A computer-based randomization procedure was permitted to choose the side, subject to PBMT, by means of a neodymium-doped YAG (Nd: YAG) laser (Test) and Controls. Both surgeries were performed by the same operator with a gap of 40 days. Twenty-two days after each surgery, a biopsy in correspondence to the alveolar mucosa of the socket was obtained from both sites and observed with an optical microscope and analyzed with histomorphometric analysis and immunohistochemistry.
RESULTS


Each of the 20 participants included in this study (11 women and 9 men, nonsmokers, mean age 16 years in the range of 15 to 17 years) were subjected to the extraction of both lower third molars, and a side was treated as control, the other, as the test. The histomorphometric analysis and immunohistochemistry showed that the tested sites, contrary to controls, were characterized by a lower presence of inflammatory cells, a more mature epithelium and myofibroblasts incorporated in a network of fibers parallel to the basal membrane, with little positivity to alpha-SMA antibodies and anti-myosin but positivity to anti-desmin.
CONCLUSIONS


In conclusion, PBMT accelerates the healing process of postextraction alveolus after the third molar extraction.",2020,"The histomorphometric analysis and immunohistochemistry showed that the tested sites, contrary to controls, were characterized by a lower presence of inflammatory cells, a more mature epithelium and myofibroblasts incorporated in a network of fibers parallel to the basal membrane, with little positivity to alpha-SMA antibodies and anti-myosin but positivity to anti-desmin.
CONCLUSIONS


","['Inclusion criteria were no smokers subjects with the necessity to extract both lower third molars with surgeries overlapping for duration and difficulty', '20 participants included in this study (11 women and 9 men, nonsmokers, mean age 16\xa0years in the range of 15 to 17 years', 'Twenty systemically healthy patients who needed to extract both lower third molars were selected in a private clinic']","['neodymium-doped YAG (Nd: YAG) laser (Test) and Controls', 'photobiomodulation (PBMT', 'Photobiomodulation', 'PBMT']","['healing process of postextraction alveolus', 'Healing of Postextraction Alveolar Sockets']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0227130', 'cui_str': 'Structure of alveolus dentalis'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}]",11.0,0.0376832,"The histomorphometric analysis and immunohistochemistry showed that the tested sites, contrary to controls, were characterized by a lower presence of inflammatory cells, a more mature epithelium and myofibroblasts incorporated in a network of fibers parallel to the basal membrane, with little positivity to alpha-SMA antibodies and anti-myosin but positivity to anti-desmin.
CONCLUSIONS


","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Scarano', 'Affiliation': 'Full Professor of Oral Surgery, Department of Medical, Oral and Biotechnological Sciences, University of Chieti-Pescara, Italy; Research staff at Zirconia Implant Research Group (Z.I.R.G), International Academy of Ceramic Implantology; and Visiting Professor, Department of Oral Implantology, Dental Research Division, College Ingà, UNINGÁ, Cachoeiro de Itapemirim, Brazil. Electronic address: ascarano@unich.it.'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Lorusso', 'Affiliation': 'Student, Department of Medical, Oral and Biotechnological Sciences, University of Chieti-Pescara, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Postiglione', 'Affiliation': 'Student of Oral Surgery Specialty, Department of Medical, Oral and Biotechnological Sciences, University of Chieti-Pescara, Italy.'}, {'ForeName': 'Filiberto', 'Initials': 'F', 'LastName': 'Mastrangelo', 'Affiliation': 'Associate Professor of Oral Surgery Clinical and Experimental Medicine, Medical School, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Morena', 'Initials': 'M', 'LastName': 'Petrini', 'Affiliation': 'Postdoctoral Researcher, Department of Medical, Oral and Biotechnological Sciences, University of Chieti-Pescara, Italy.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.09.008']
2846,33058774,Third Molar Surgery Outcomes: A Randomized Clinical Trial Comparing Submucosal and Intravenous Dexamethasone.,"OBJECTIVE


Swelling, pain, and trismus after third molar surgery have a negative impact on patients' quality of life in the days following surgery. The study aims to compare the efficacy of submucosal (SM) dexamethasone and intravenous (IV) dexamethasone in reducing these outcomes.
METHODS


The single-center study was designed as a randomized, controlled, double-blinded trial with a total of 130 participants evenly allocated into two treatment groups. All participants underwent the surgical removal of at least two mandibular third molars under intravenous sedation. The outcome variables studied were swelling, pain, and maximum incisal distances. The swelling was measured using a 3-dimensional camera (3dMD Inc, Atlanta, GA). The pain was quantified using a 100 mm visual analog scale (VAS). Maximum incisal distances were measured using a caliper. Participants completed the short-form Oral Health Impact Profile (OHIP-14). The two groups were compared using cross-tabulations and chi-square tests for categorical variables and analysis of variance for continuous variables.
RESULTS


The participants had a mean age of 22.6 years, 56.8% females and 12.4% smokers. There were no statistically significant differences in the distribution of study variables between the two groups. On day 2, mean facial swelling measurements were 7.3 cm 3  in the IV group and 7.8 cm 3  in the SM group (P > .05). The mean pain score was 31 in the IV group and 33 in the SM group (P > .05). The mean maximum incisal distances were 33.7 mm in the IV group and 34.5 mm in the SM group (P > .05). Both groups experienced poorer quality-of-life relative to baseline scores and were affected to a similar extent.
CONCLUSIONS


There are no differences in swelling, pain, and trismus between submucosal and intravenous dexamethasone in third molar surgery. Submucosal dexamethasone is a straightforward and accessible route of steroid administration in patients having third molar surgery under local anesthesia only.",2020,The mean maximum incisal distances were 33.7 mm in the IV group and 34.5 mm in the SM group (P > .05).,"['participants had a mean age of 22.6\xa0years, 56.8% females and 12.4% smokers', '130 participants evenly allocated into two treatment groups', 'patients having third molar surgery under local anesthesia only', 'All participants underwent the surgical removal of at least two mandibular third molars under intravenous sedation', 'Third Molar Surgery Outcomes']","['Submucosal dexamethasone', 'dexamethasone', 'Dexamethasone', 'submucosal (SM) dexamethasone and intravenous (IV) dexamethasone']","['mean pain score', 'swelling, pain, and trismus', 'mean maximum incisal distances', 'mean facial swelling measurements', 'poorer quality-of-life', 'swelling, pain, and maximum incisal distances', 'short-form Oral Health Impact Profile (OHIP-14', 'Maximum incisal distances', 'pain']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0412775', 'cui_str': 'Intravenous sedation'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4040028', 'cui_str': 'Incisal'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",130.0,0.426829,The mean maximum incisal distances were 33.7 mm in the IV group and 34.5 mm in the SM group (P > .05).,"[{'ForeName': 'Adelyn', 'Initials': 'A', 'LastName': 'Ai Lyn Lau', 'Affiliation': 'Oral Surgery DClinDent, Specialist Oral Surgeon - Private Practitioner, Faculty of Dentistry, University of Otago, Department of Oral Diagnostics and Surgical Sciences, Dunedin, New Zealand. Electronic address: Dr.adelynlau@gmail.com.'}, {'ForeName': 'Rohana Kumara', 'Initials': 'RK', 'LastName': 'De Silva', 'Affiliation': 'Associate Professor, Consultant Oral and Maxillofacial Surgeon, Faculty of Dentistry, University of Otago, Department of Oral Diagnostics and Surgical Sciences, Dunedin, New Zealand.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Thomson', 'Affiliation': 'Professor of Dental Epidemiology and Public Health, Faculty of Dentistry, University of Otago, Department of Oral Diagnostics and Surgical Sciences, Dunedin, New Zealand.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'De Silva', 'Affiliation': 'Consultant Oral and Maxillofacial Surgeon, Faculty of Dentistry, University of Otago, Department of Oral Diagnostics and Surgical Sciences, Dunedin, New Zealand.'}, {'ForeName': 'Darryl', 'Initials': 'D', 'LastName': 'Tong', 'Affiliation': 'Professor, Consultant Oral and Maxillofacial Surgeon, Head of Department of Oral Diagnostic and Surgical Sciences, Faculty of Dentistry, University of Otago, Department of Oral Diagnostics and Surgical Sciences, Dunedin, New Zealand.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.09.020']
2847,33058795,"Efficacy and safety of cefiderocol or best available therapy for the treatment of serious infections caused by carbapenem-resistant Gram-negative bacteria (CREDIBLE-CR): a randomised, open-label, multicentre, pathogen-focused, descriptive, phase 3 trial.","BACKGROUND


New antibiotics are needed for the treatment of patients with life-threatening carbapenem-resistant Gram-negative infections. We assessed the efficacy and safety of cefiderocol versus best available therapy in adults with serious carbapenem-resistant Gram-negative infections.
METHODS


We did a randomised, open-label, multicentre, parallel-group, pathogen-focused, descriptive, phase 3 study in 95 hospitals in 16 countries in North America, South America, Europe, and Asia. We enrolled patients aged 18 years or older admitted to hospital with nosocomial pneumonia, bloodstream infections or sepsis, or complicated urinary tract infections (UTI), and evidence of a carbapenem-resistant Gram-negative pathogen. Participants were randomly assigned (2:1 by interactive web or voice response system) to receive either a 3-h intravenous infusion of cefiderocol 2 g every 8 h or best available therapy (pre-specified by the investigator before randomisation and comprised of a maximum of three drugs) for 7-14 days. For patients with pneumonia or bloodstream infection or sepsis, cefiderocol treatment could be combined with one adjunctive antibiotic (excluding polymyxins, cephalosporins, and carbapenems). The primary endpoint for patients with nosocomial pneumonia or bloodstream infection or sepsis was clinical cure at test of cure (7 days [plus or minus 2] after the end of treatment) in the carbapenem-resistant microbiological intention-to-treat population (ITT; ie, patients with a confirmed carbapenem-resistant Gram-negative pathogen receiving at least one dose of study drug). For patients with complicated UTI, the primary endpoint was microbiological eradication at test of cure in the carbapenem-resistant microbiological ITT population. Safety was evaluated in the safety population, consisting of all patients who received at least one dose of study drug. Mortality was reported through to the end of study visit (28 days [plus or minus 3] after the end of treatment). Summary statistics, including within-arm 95% CIs calculated using the Clopper-Pearson method, were collected for the primary and safety endpoints. This trial is registered with ClinicalTrials.gov (NCT02714595) and EudraCT (2015-004703-23).
FINDINGS


Between Sept 7, 2016, and April 22, 2019, we randomly assigned 152 patients to treatment, 101 to cefiderocol, 51 to best available therapy. 150 patients received treatment: 101 cefiderocol (85 [85%] received monotherapy) and 49 best available therapy (30 [61%] received combination therapy). In 118 patients in the carbapenem-resistant microbiological ITT population, the most frequent carbapenem-resistant pathogens were Acinetobacter baumannii (in 54 patients [46%]), Klebsiella pneumoniae (in 39 patients [33%]), and Pseudomonas aeruginosa (in 22 patients [19%]). In the same population, for patients with nosocomial pneumonia, clinical cure was achieved by 20 (50%, 95% CI 33·8-66·2) of 40 patients in the cefiderocol group and ten (53%, 28·9-75·6) of 19 patients in the best available therapy group; for patients with bloodstream infection or sepsis, clinical cure was achieved by ten (43%, 23·2-65·5) of 23 patients in the cefiderocol group and six (43%, 17·7-71·1) of 14 patients in the best available therapy group. For patients with complicated UTIs, microbiological eradication was achieved by nine (53%, 27·8-77·0) of 17 patients in the cefiderocol group and one (20%, 0·5-71·6) of five patients in the best available therapy group. In the safety population, treatment-emergent adverse events were noted for 91% (92 patients of 101) of the cefiderocol group and 96% (47 patients of 49) of the best available therapy group. 34 (34%) of 101 patients receiving cefiderocol and nine (18%) of 49 patients receiving best available therapy died by the end of the study; one of these deaths (in the best available therapy group) was considered to be related to the study drug.
INTERPRETATION


Cefiderocol had similar clinical and microbiological efficacy to best available therapy in this heterogeneous patient population with infections caused by carbapenem-resistant Gram-negative bacteria. Numerically more deaths occurred in the cefiderocol group, primarily in the patient subset with Acinetobacter spp infections. Collectively, the findings from this study support cefiderocol as an option for the treatment of carbapenem-resistant infections in patients with limited treatment options.
FUNDING


Shionogi.",2020,"Numerically more deaths occurred in the cefiderocol group, primarily in the patient subset with Acinetobacter spp infections.","['95 hospitals in 16 countries in North America, South America, Europe, and Asia', 'resistant microbiological intention-to-treat population (ITT; ie, patients with a confirmed carbapenem-resistant Gram-negative pathogen receiving at least one dose of study drug', 'Between Sept 7, 2016, and April 22, 2019', '101 patients receiving cefiderocol and nine (18%) of 49 patients receiving best available therapy died by the end of the study; one of these deaths (in the best available therapy group) was considered to be related to the study drug', 'enrolled patients aged 18 years or older admitted to hospital with nosocomial pneumonia, bloodstream infections or sepsis, or complicated urinary tract infections (UTI), and evidence of a carbapenem-resistant Gram-negative pathogen', 'patients with life-threatening carbapenem-resistant Gram-negative infections', 'serious infections caused by carbapenem-resistant Gram-negative bacteria (CREDIBLE-CR', '150 patients received treatment: 101 cefiderocol (85 [85%] received', 'patients with pneumonia or bloodstream infection or sepsis, cefiderocol treatment', '118 patients in the carbapenem-resistant microbiological ITT population', 'adults with serious carbapenem-resistant Gram-negative infections']","['cefiderocol', 'combination therapy', 'carbapenem', 'cefiderocol 2 g every 8 h or best available therapy', 'monotherapy', 'EudraCT']","['Safety', 'Mortality', 'bloodstream infection or sepsis, clinical cure', 'efficacy and safety', 'nosocomial pneumonia, clinical cure', 'deaths', 'Efficacy and safety', 'microbiological eradication', 'Klebsiella pneumoniae', 'nosocomial pneumonia or bloodstream infection or sepsis was clinical cure at test of cure']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0006968', 'cui_str': 'Carbapenem'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4548369', 'cui_str': 'cefiderocol'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0949083', 'cui_str': 'Hospital acquired pneumonia'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C4552431', 'cui_str': 'Complicated urinary tract infection'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0018150', 'cui_str': 'Gram-negative bacterium'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4548369', 'cui_str': 'cefiderocol'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0006968', 'cui_str': 'Carbapenem'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0949083', 'cui_str': 'Hospital acquired pneumonia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0001699', 'cui_str': 'Klebsiella pneumoniae'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",152.0,0.13506,"Numerically more deaths occurred in the cefiderocol group, primarily in the patient subset with Acinetobacter spp infections.","[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bassetti', 'Affiliation': 'Infectious Diseases Clinic, Department of Health Sciences, University of Genoa, Genoa and Hospital Policlinico San Martino IRCCS, Genoa, Italy.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Echols', 'Affiliation': 'Infectious Disease Drug Development Consulting, Easton, CT, USA.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Matsunaga', 'Affiliation': 'Shionogi, Florham Park, NJ, USA.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Ariyasu', 'Affiliation': 'Shionogi, Osaka, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Doi', 'Affiliation': 'Division of Infectious Diseases, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Ricard', 'Initials': 'R', 'LastName': 'Ferrer', 'Affiliation': ""Department of Intensive Care Medicine and SODIR-VHIR Research Group, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.""}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Lodise', 'Affiliation': 'Albany College of Pharmacy and Health Sciences, Albany, NY, USA.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Naas', 'Affiliation': 'Department of Medical Microbiology, Bicêtre Hospital, Paris, France.'}, {'ForeName': 'Yoshihito', 'Initials': 'Y', 'LastName': 'Niki', 'Affiliation': 'Department of Clinical Infectious Diseases, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Paterson', 'Affiliation': 'UQ Centre for Clinical Research, Faculty of Medicine, The University of Queensland, Herston, QLD, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Portsmouth', 'Affiliation': 'Shionogi, Florham Park, NJ, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Torre-Cisneros', 'Affiliation': 'Maimonides Institute for Biomedical Research, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Kiichiro', 'Initials': 'K', 'LastName': 'Toyoizumi', 'Affiliation': 'Shionogi, Osaka, Japan.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Wunderink', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Tsutae D', 'Initials': 'TD', 'LastName': 'Nagata', 'Affiliation': 'Shionogi, Osaka, Japan. Electronic address: tsutae.den.nagata@shionogi.co.jp.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30796-9']
2848,33058798,"Cefiderocol versus high-dose, extended-infusion meropenem for the treatment of Gram-negative nosocomial pneumonia (APEKS-NP): a randomised, double-blind, phase 3, non-inferiority trial.","BACKGROUND


Nosocomial pneumonia due to multidrug-resistant Gram-negative pathogens poses an increasing challenge. We compared the efficacy and safety of cefiderocol versus high-dose, extended-infusion meropenem for adults with nosocomial pneumonia.
METHODS


We did a randomised, double-blind, parallel-group, phase 3, non-inferiority trial in 76 centres in 17 countries in Asia, Europe, and the USA (APEKS-NP). We enrolled adults aged 18 years and older with hospital-acquired, ventilator-associated, or health-care-associated Gram-negative pneumonia, and randomly assigned them (1:1 by interactive response technology) to 3-h intravenous infusions of either cefiderocol 2 g or meropenem 2 g every 8 h for 7-14 days. All patients also received open-label intravenous linezolid (600 mg every 12 h) for at least 5 days. An unmasked pharmacist prepared the assigned treatments; investigators and patients were masked to treatment assignment. Only the unmasked pharmacist was aware of the study drug assignment for the infusion bags, which were administered in generic infusion bags labelled with patient and study site identification numbers. Participants were stratified at randomisation by infection type and Acute Physiology and Chronic Health Evaluation II (APACHE II) score (≤15 and ≥16). The primary endpoint was all-cause mortality at day 14 in the modified intention-to-treat (ITT) population (ie, all patients receiving at least one dose of study drug, excluding patients with Gram-positive monomicrobial infections). The analysis was done for all patients with known vital status. Non-inferiority was concluded if the upper bound of the 95% CI for the treatment difference between cefiderocol and meropenem groups was less than 12·5%. Safety was investigated to the end of the study in the safety population, which included all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT03032380, and EudraCT, 2016-003020-23.
FINDINGS


Between Oct 23, 2017, and April 14, 2019, we randomly assigned 148 participants to cefiderocol and 152 to meropenem. Of 292 patients in the modified ITT population, 251 (86%) had a qualifying baseline Gram-negative pathogen, including Klebsiella pneumoniae (92 [32%]), Pseudomonas aeruginosa (48 [16%]), Acinetobacter baumannii (47 [16%]), and Escherichia coli (41 [14%]). 142 (49%) patients had an APACHE II score of 16 or more, 175 (60%) were mechanically ventilated, and 199 (68%) were in intensive care units at the time of randomisation. All-cause mortality at day 14 was 12·4% with cefiderocol (18 patients of 145) and 11·6% with meropenem (17 patients of 146; adjusted treatment difference 0·8%, 95% CI -6·6 to 8·2; p=0·002 for non-inferiority hypothesis). Treatment-emergent adverse events were reported in 130 (88%) of 148 participants in the cefiderocol group and 129 (86%) of 150 in the meropenem group. The most common treatment-emergent adverse event was urinary tract infection in the cefiderocol group (23 patients [16%] of 148) and hypokalaemia in the meropenem group (23 patients [15%] of 150). Two participants (1%) of 148 in the cefiderocol group and two (1%) of 150 in the meropenem group discontinued the study because of drug-related adverse events.
INTERPRETATION


Cefiderocol was non-inferior to high-dose, extended-infusion meropenem in terms of all-cause mortality on day 14 in patients with Gram-negative nosocomial pneumonia, with similar tolerability. The results suggest that cefiderocol is a potential option for the treatment of patients with nosocomial pneumonia, including those caused by multidrug-resistant Gram-negative bacteria.
FUNDING


Shionogi.",2020,Treatment-emergent adverse events were reported in 130 (88%) of 148 participants in the cefiderocol group and 129 (86%) of 150 in the meropenem group.,"['Between Oct 23, 2017, and April 14, 2019', '148 participants to cefiderocol and 152 to', '292 patients in the modified ITT population, 251 (86%) had a qualifying baseline Gram-negative pathogen, including Klebsiella pneumoniae (92 [32%]), Pseudomonas aeruginosa (48 [16%]), Acinetobacter baumannii (47 [16%]), and Escherichia coli (41 [14', '76 centres in 17 countries in Asia, Europe, and the USA (APEKS-NP', 'Participants were stratified at randomisation by infection type and Acute Physiology and Chronic Health Evaluation II (APACHE II) score (≤15 and ≥16', 'patients with nosocomial pneumonia', 'adults with nosocomial pneumonia', 'patients with known vital status', 'patients who received at least one dose of study drug', '142 (49%) patients had an APACHE II score of 16 or more, 175 (60%) were mechanically ventilated, and 199 (68%) were in intensive care units at the time of randomisation', 'enrolled adults aged 18 years and older with hospital-acquired, ventilator-associated, or health-care-associated Gram-negative pneumonia']","['cefiderocol 2 g or meropenem', 'Cefiderocol versus high-dose, extended-infusion meropenem', 'meropenem', 'open-label intravenous linezolid', 'cefiderocol']","['hypokalaemia', 'cause mortality', 'efficacy and safety', 'urinary tract infection', 'All-cause mortality']","[{'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4548369', 'cui_str': 'cefiderocol'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001699', 'cui_str': 'Klebsiella pneumoniae'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C0085467', 'cui_str': 'Acinetobacter calcoaceticus'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0243028', 'cui_str': 'Acute physiology and chronic health evaluation II'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0949083', 'cui_str': 'Hospital acquired pneumonia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C4758051', 'cui_str': 'APACHE II (Acute Physiology and Chronic Health Evaluation II) score'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0456393', 'cui_str': 'Hospital acquired'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0854248', 'cui_str': 'Pneumonia due to Gram negative bacteria'}]","[{'cui': 'C4548369', 'cui_str': 'cefiderocol'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0663241', 'cui_str': 'linezolid'}]","[{'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}]",148.0,0.468352,Treatment-emergent adverse events were reported in 130 (88%) of 148 participants in the cefiderocol group and 129 (86%) of 150 in the meropenem group.,"[{'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Wunderink', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Matsunaga', 'Affiliation': 'Shionogi, Florham Park, NJ, USA.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Ariyasu', 'Affiliation': 'Shionogi & Co, Osaka, Japan.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Clevenbergh', 'Affiliation': 'Brugmann University Hospital, Brussels, Belgium.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Echols', 'Affiliation': 'Infectious Disease Drug Development Consulting, Easton, CT, USA.'}, {'ForeName': 'Keith S', 'Initials': 'KS', 'LastName': 'Kaye', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Marin', 'Initials': 'M', 'LastName': 'Kollef', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, John T Milliken Department of Medicine, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Menon', 'Affiliation': 'Shionogi, Florham Park, NJ, USA.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Pogue', 'Affiliation': 'Department of Clinical Pharmacy, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Andrew F', 'Initials': 'AF', 'LastName': 'Shorr', 'Affiliation': 'Pulmonary and Critical Care Medicine, Medstar Washington Hospital Center, Washington DC, USA; Georgetown University, Washington DC, USA.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Timsit', 'Affiliation': 'UMR 1137, IAME Inserm/Université de Paris - Paris Diderot, Paris, France; APHP, Bichat Hospital, Medical and Infectious Diseases ICU, F75018 Paris, France.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Zeitlinger', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Tsutae D', 'Initials': 'TD', 'LastName': 'Nagata', 'Affiliation': 'Shionogi & Co, Osaka, Japan. Electronic address: tsutae.den.nagata@shionogi.co.jp.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30731-3']
2849,33058835,Exogenous testosterone decreases men's sensitivity to vocal cues of male dominance.,"Assessing dominance is important for effective social interactions, and prior research suggests that testosterone is associated with men's dominance perceptions. The present study tested for a causal effect of exogenous testosterone on men's sensitivity to vocal cues of other men's dominance, an important parameter in male-male competition across species. One hundred and thirty-nine Chinese men received a single dose (150 mg) of testosterone or placebo gel in a double-blind, placebo-controlled, between-participant design. Participants reported their own dominance and judged other men's dominance from voices. Men's dominance sensitivity was significantly weaker in the testosterone group compared to those in the placebo group. Moreover, men's dominance sensitivity was negatively associated with their self-reported dominance in our Chinese sample, consistent with findings from Western populations. These results indicate that exogenous testosterone has a causal effect in decreasing men's dominance sensitivity, consistent with the Challenge Hypothesis, suggesting that the fluctuation of testosterone concentration mediates individuals' behaviors. Additionally, the present study could motivate further work on vocal assessment in the context of competition in humans and other species.",2020,Men's dominance sensitivity was significantly weaker in the testosterone group compared to those in the placebo group.,"['One hundred and thirty-nine Chinese men', ""men's sensitivity to vocal cues of other men's dominance""]","['testosterone or placebo gel', 'Exogenous testosterone', 'testosterone', 'exogenous testosterone', 'placebo']","[""Men's dominance sensitivity""]","[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205101', 'cui_str': 'External'}]","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",139.0,0.161778,Men's dominance sensitivity was significantly weaker in the testosterone group compared to those in the placebo group.,"[{'ForeName': 'Chengyang', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Watkins', 'Affiliation': 'Division of Psychology, School of Applied Sciences, Abertay University, Dundee, United Kingdom.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Nan', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Ou', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'School of Business Administration, Zhejiang University of Finance and Economics, Hangzhou, China.'}, {'ForeName': 'Xiangqian', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China. Electronic address: yinwu0407@gmail.com.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104871']
2850,33059108,The influence of violet LED light on tooth bleaching protocols: in vitro study of bleaching effectiveness.,"BACKGROUND


Employing violet LED on tooth bleaching is a recent but promising technique. This study aimed to assess the bleaching effectiveness of violet light-emitting diodes (LEDs) associated or not with bleaching gels containing hydrogen peroxide (HP) or carbamide peroxide (CP).
METHODS


seventy bovine incisors were randomly assigned into 7 groups (n = 10) according to the technique and whitening product used. Group C: Artificial saliva (placebo); Group HP L-: three sessions of HP at 35% without light activation; Group CP L-: three weeks of CP at 16% for 4 h/day; Group HP CP L-: three sessions of HP at 35% without light activation + 2 weeks of CP at 16%, for 4 h/day; Group LED: four sessions with violet LED; Group HP L+: three sessions with HP at 35% + violet LED; Group CP L+: three weeks with CP at 16% for 4 h/day + violet LED. Color changes (ΔE and ΔL) were measured with a portable digital spectrophotometer.
RESULTS


The results were similar between the groups of bleaching protocols, demonstrating that the use of the violet LED did not influenced bleaching effectiveness when using HP 35% or CP 16% after 3 sessions. In addition, the use of the violet LED alone obtained ΔE values ​​similar to the protocols with the use of peroxides, however less variation of ΔL was observed for this group.
CONCLUSIONS


The use of violet LEDs associated or not with bleaching gels was effective for tooth whitening. In addition, it was also concluded that the physical lightening technique with violet LED used alone produced less variation in dental brightness.",2020,"The results were similar between the groups of bleaching protocols, demonstrating that the use of the violet LED did not influenced bleaching effectiveness when using HP 35% or CP 16% after 3 sessions.",['seventy bovine incisors'],"['bleaching gels containing hydrogen peroxide (HP) or carbamide peroxide (CP', 'HP at 35% + violet LED; Group CP', 'violet LED light', 'saliva (placebo); Group HP L', 'violet light-emitting diodes (LEDs', 'L', 'violet LEDs', 'violet LED; Group HP']","['bleaching effectiveness', 'dental brightness', 'Color changes (ΔE and ΔL']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0108342', 'cui_str': 'carbamide peroxide'}, {'cui': 'C0330463', 'cui_str': 'Viola'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}]","[{'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0475330', 'cui_str': 'Color change'}]",70.0,0.0246578,"The results were similar between the groups of bleaching protocols, demonstrating that the use of the violet LED did not influenced bleaching effectiveness when using HP 35% or CP 16% after 3 sessions.","[{'ForeName': 'Thaiany Wendy', 'Initials': 'TW', 'LastName': 'Silva Daltro', 'Affiliation': 'Universidade Federal de Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Suênia Andressa', 'Initials': 'SA', 'LastName': 'Gomes de Almeida', 'Affiliation': 'Universidade Federal de Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Marlon Ferreira', 'Initials': 'MF', 'LastName': 'Dias', 'Affiliation': 'Universidade Estadual Paulista, UNESP, Araraquara, SP, Brazil.'}, {'ForeName': 'Paulo Cardoso', 'Initials': 'PC', 'LastName': 'Lins-Filho', 'Affiliation': 'Universidade Federal de Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Claudio Heliomar Vicente', 'Initials': 'CHV', 'LastName': 'da Silva', 'Affiliation': 'Universidade Federal de Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Renata Pedrosa', 'Initials': 'RP', 'LastName': 'Guimarães', 'Affiliation': 'Universidade Federal de Pernambuco, Recife, PE, Brazil. Electronic address: renatapguimaraes@gmail.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.102052']
2851,33059233,Transverse abdominis activity and ultrasound biofeedback in college golfers with and without low back pain.,"OBJECTIVES


To compare transverse abdominis (TrA) muscle activity in college golfers with and without a history of low back pain (LBP) and examine the effects of ultrasound biofeedback and a functional golf-setup position on TrA activity.
DESIGN


Crossover study.
SETTING


Laboratory.
PARTICIPANTS


Thirty-two (n = 32) collegiate golfers were stratified into either the LBP group (n = 16, 4.6 ± 4.5 LBP episodes) or non-LBP group (n = 16, 0.1 ± 0.3 LBP episodes) based on LBP episodes in the last 6-months.
MAIN OUTCOME MEASURES


Ultrasound measures of TrA activity were performed during standard contractions and contractions with ultrasound biofeedback. Contraction-type order was randomized between two visits. Testing was performed in two positions, supine and golf-setup positions.
RESULTS


We observed no significant differences in TrA activity between the LBP and non-LBP groups. Overall, TrA activity was greater during biofeedback contractions compared to standard contractions, and TrA activity was lower in the golf-setup position compared to the supine position.
CONCLUSIONS


We observed no differences in TrA activity between college golfers with and without LBP. College golfers with and without LBP demonstrated a greater ability to contract their TrA with real-time ultrasound biofeedback and a lower ability to contract their TrA in the functional golf-setup position compared to the traditional supine position.",2020,College golfers with and without LBP demonstrated a greater ability to contract their TrA with real-time ultrasound biofeedback and a lower ability to contract their TrA in the functional golf-setup position compared to the traditional supine position.,"['college golfers with and without low back pain', 'Thirty-two (n\xa0=\xa032) collegiate golfers', 'college golfers with and without a history of low back pain (LBP']","['ultrasound biofeedback and a functional golf-setup position', 'LBP', 'LBP episodes) or non-LBP']","['Transverse abdominis activity and ultrasound biofeedback', 'standard contractions and contractions with ultrasound biofeedback', 'Overall, TrA activity', 'transverse abdominis (TrA) muscle activity', 'TrA activity']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018041', 'cui_str': 'Golfing'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]","[{'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",32.0,0.02025,College golfers with and without LBP demonstrated a greater ability to contract their TrA with real-time ultrasound biofeedback and a lower ability to contract their TrA in the functional golf-setup position compared to the traditional supine position.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Skibski', 'Affiliation': 'Department of Exercise Science & Athletic Training, Adrian College, Adrian, MI, USA. Electronic address: askibski19@adrian.edu.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Burkholder', 'Affiliation': 'Department of Exercise Science & Athletic Training, Adrian College, Adrian, MI, USA. Electronic address: eburkholder@adrian.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Goetschius', 'Affiliation': 'Department of Health Professions, James Madison University, Harrisonburg, VA, USA. Electronic address: goetscjw@jmu.edu.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.10.004']
2852,33059997,Long-term outcomes of a prospective randomized trial of  131 Cs/ 125 I permanent prostate brachytherapy.,"PURPOSE


Iodine-125 ( 125 I) is the most commonly used isotope for prostate brachytherapy (BT). Cesium-131 ( 131 Cs) has a higher dose rate and shorter dose delivery time resulting in decreased duration of acute urinary morbidity. Long-term data suggest excellent oncologic outcomes; it is not known how outcomes compare. A prospective randomized trial comparing the two isotopes was initiated.
MATERIALS AND METHODS


Patients with low- or intermediate-risk disease were treated with a BT in a single outpatient facility. Prescription dose was 144 Gy for  125 I and 115 Gy for  131 Cs. Androgen deprivation or supplemental EBRT was not allowed. The primary study objective was comparison of the mean EPIC Urinary Domain Score. Secondary objective was biochemical relapse-free survival (BRFS) comparison. Time-to-event for all outcomes of interest was measured from implant date.
RESULTS


One hundred forty men were enrolled; 81.4% were low-risk and 18.6% were intermediate-risk. The median followup was 97 months. Urinary and sexual health-related quality of life did not differ between isotopes at any recorded time point. At 2 months after implantation, bowel health-related quality of life was worse with  125 I; however, this difference was lost at subsequent time points. The 9-year BRFS was 87.2% and 84.0% for the  125 I and  131 Cs group, respectively (p = 0.897). There was no statistically significant difference in BRFS based on initial T stage, PSA, or Gleason score.
CONCLUSIONS


Short- and long-term urinary, sexual, and bowel quality of life, as well as long-term biochemical control were comparable between  125 I and  131 Cs. This report therefore supports the continued use of  131 Cs as an effective and comparable alternative isotope.",2020,"At 2 months after implantation, bowel health-related quality of life was worse with  ","['One hundred forty men were enrolled; 81.4% were low-risk and 18.6% were intermediate-risk', 'Patients with low- or intermediate-risk disease were treated with a BT in a single outpatient facility', '125']","['131 Cs/ 125 I permanent prostate brachytherapy', 'Androgen deprivation or supplemental EBRT']","['BRFS based on initial T stage, PSA, or Gleason score', 'Urinary and sexual health-related quality of life', 'mean EPIC Urinary Domain Score', 'bowel health-related quality of life', '9-year BRFS', 'biochemical relapse-free survival (BRFS) comparison']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C0796396', 'cui_str': 'Iodine-125'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0854662', 'cui_str': 'Brachytherapy to prostate'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0475455', 'cui_str': 'T - Tumor stage'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0332326', 'cui_str': 'Gleason grading system for prostatic cancer'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",140.0,0.0642372,"At 2 months after implantation, bowel health-related quality of life was worse with  ","[{'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Moran', 'Affiliation': 'Prostate Cancer Foundation of Chicago, Westmont, IL.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Koroulakis', 'Affiliation': 'Department of Radiation Oncology, University of Maryland Medical Center, Baltimore, MD.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Decesaris', 'Affiliation': 'Department of Radiation Oncology, University of Maryland Medical Center, Baltimore, MD.'}, {'ForeName': 'Michelle H', 'Initials': 'MH', 'LastName': 'Braccioforte', 'Affiliation': 'Prostate Cancer Foundation of Chicago, Westmont, IL; Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Amin', 'Affiliation': 'Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Manuj', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': 'Department of Radiation Oncology, Perelman Center for Advanced Medicine, University of Pennsylvania Philadelphia, PA. Electronic address: magarwalmd@gmail.com.'}]",Brachytherapy,['10.1016/j.brachy.2020.07.005']
2853,33060043,Antioxidant activity of Hydroxytyrosol and Vitamin E reduces systemic inflammation in children with paediatric NAFLD.,"BACKGROUND


The rise in paediatric non-alcoholic fatty liver disease (NAFLD) is particularly alarming. We recently reported that Hydroxytyrosol (HXT) and Vitamin E (VitE) may improve oxidative stress, insulin resistance, and steatosis in children with biopsy-proven NAFLD.
AIM


Here, we investigated if HXT+VitE may reduce systemic inflammation in the above-mentioned patients.
METHODS


This study analysed the plasma levels of IL (interleukin)-6, IL-1β, IL-10, tumour necrosis factor (TNF)-α, 4‑hydroxy-2-nonenal (4-HNE) and 8-hydroxy-2'deoxyguanosine (8-OHdG) in children enrolled in the HXT+VitE trial (ClinicalTrials.gov, NCT02842567).
RESULTS


Changes in markers of systemic inflammation were found in both placebo (Pla) and HXT+VitE. In particular, after four months, the levels of IL-1β and TNF-α were reduced in both groups, while IL-6 decreased, and IL-10 increased significantly only in the group treated with HXT+VitE. Children treated with HXT+VitE showed a significant decrease of 4-HNE and 8-OHdG that correlated with the improvement of triglyceride levels. Noticeably, only the 8-OHdG decrease correlated with steatosis amelioration and with the increase of IL-10 levels.
CONCLUSION


The treatment with HXT and VitE reduced the NAFLD-related systemic inflammation in children, mainly by an increase of IL-10 circulating levels that occurred in response to DNA damage recovery, ultimately improving steatosis and hypertriglyceridemia.",2020,"In particular, after four months, the levels of IL-1β and TNF-α were reduced in both groups, while IL-6 decreased, and IL-10 increased significantly only in the group treated with HXT+VitE. Children treated with HXT+VitE showed a significant decrease of 4-HNE and 8-OHdG that correlated with the improvement of triglyceride levels.","['children with paediatric NAFLD', 'children with biopsy-proven NAFLD', 'children enrolled in the HXT+VitE trial (ClinicalTrials.gov, NCT02842567']","['HXT+VitE', 'Hydroxytyrosol and Vitamin E', 'Hydroxytyrosol (HXT) and Vitamin E (VitE', 'HXT', 'placebo (Pla) and HXT+VitE']","['systemic inflammation', 'triglyceride levels', 'levels of IL-1β and TNF-α', 'steatosis amelioration', '4-HNE and 8-OHdG', 'NAFLD-related systemic inflammation', 'IL-6 decreased, and IL-10', 'steatosis and hypertriglyceridemia', 'IL-10 levels', 'oxidative stress, insulin resistance, and steatosis', ""plasma levels of IL (interleukin)-6, IL-1β, IL-10, tumour necrosis factor (TNF)-α, 4‑hydroxy-2-nonenal (4-HNE) and 8-hydroxy-2'deoxyguanosine (8-OHdG""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0243264', 'cui_str': 'hydroxytyrosol'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0046464', 'cui_str': '2-nonenal'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",,0.317528,"In particular, after four months, the levels of IL-1β and TNF-α were reduced in both groups, while IL-6 decreased, and IL-10 increased significantly only in the group treated with HXT+VitE. Children treated with HXT+VitE showed a significant decrease of 4-HNE and 8-OHdG that correlated with the improvement of triglyceride levels.","[{'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Mosca', 'Affiliation': ""Unit of Hepatology, Gastroenterology, and Nutrition, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.""}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Crudele', 'Affiliation': ""Research Unit of Molecular Genetics of Complex Phenotypes, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.""}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Smeriglio', 'Affiliation': 'Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, Messina, Italy.'}, {'ForeName': 'Maria Rita', 'Initials': 'MR', 'LastName': 'Braghini', 'Affiliation': ""Research Unit of Molecular Genetics of Complex Phenotypes, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Panera', 'Affiliation': ""Research Unit of Molecular Genetics of Complex Phenotypes, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.""}, {'ForeName': 'Donatella', 'Initials': 'D', 'LastName': 'Comparcola', 'Affiliation': ""Unit of Hepato-Metabolic Diseases, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.""}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Alterio', 'Affiliation': ""Unit of Hepato-Metabolic Diseases, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.""}, {'ForeName': 'Maria Rita', 'Initials': 'MR', 'LastName': 'Sartorelli', 'Affiliation': ""Unit of Hepato-Metabolic Diseases, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Tozzi', 'Affiliation': ""Unit of Hepatology, Gastroenterology, and Nutrition, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.""}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Raponi', 'Affiliation': ""Health Directorate, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.""}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Trombetta', 'Affiliation': 'Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, Messina, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Alisi', 'Affiliation': ""Research Unit of Molecular Genetics of Complex Phenotypes, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy. Electronic address: anna.alisi@opbg.net.""}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2020.09.021']
2854,33060077,"Efficacy of neoadjuvant atezolizumab treatment in patients with advanced urothelial bladder cancer according to the BASQ classification: a study protocol for an open-label, two-cohort, phase II trial.","INTRODUCTION


Atezolizumab is a programmed death ligand-1 inhibitor for urothelial bladder cancer treatment. Atezolizumab has become the standard therapy for patients with urothelial bladder cancer who are not responding to cisplatin-based chemotherapy and is also used as a first-line treatment in cisplatin-ineligible patients. However, the efficacy of atezolizumab as a neoadjuvant chemotherapy for radical cystectomy has not yet been published and is still under study. This trial investigates the effectiveness of basal/squamous-like (BASQ) classification in the selection of an effective target group of patients with muscle-invasive bladder cancer (MIBC) for neoadjuvant atezolizumab treatment.
METHODS AND ANALYSIS


This study is an open-label, two-cohort, phase II trial. It was designed to evaluate the efficacy of neoadjuvant atezolizumab treatment in patients with MIBC (T2-4N0M0) pathological responses after neoadjuvant chemotherapy and radical cystectomy. According to the molecular subtype characteristics of previous transurethral resection of the bladder specimens, patients are divided into two groups: luminal type (KRT5/6-KRT14-FOXA1+GATA3+) and basal type (KRT5/6+KRT14+FOXA1-GATA3-). Every 3 weeks, atezolizumab is administered at a dose of 1200 mg for three cycles prior to radical cystectomy in patients with MIBC. The primary end point is objective pathological responses in the intention-to-treat patients. The secondary end point is a 1-year progression-free survival difference according to the BASQ classification in patients who underwent neoadjuvant atezolizumab treatment.
ETHICS AND DISSEMINATION


The study protocol was approved by the Institutional Review Board of Seoul National University Hospital, Seoul, Republic of Korea (H 1806-051-950). The trial is registered at ClinicalTrials.gov. The trial results will be published in peer-reviewed journals and at conferences.
TRIAL REGISTRATION NUMBER


NCT03577132.",2020,"This trial investigates the effectiveness of basal/squamous-like (BASQ) classification in the selection of an effective target group of patients with muscle-invasive bladder cancer (MIBC) for neoadjuvant atezolizumab treatment.
","['patients with advanced urothelial bladder cancer according to the BASQ classification', 'patients with muscle-invasive bladder cancer (MIBC) for neoadjuvant atezolizumab treatment', 'patients with MIBC (T2-4N0M0) pathological responses after neoadjuvant chemotherapy and radical cystectomy', 'Seoul National University Hospital, Seoul, Republic of Korea (H 1806-051-950', 'patients with urothelial bladder cancer who are not responding to']","['cisplatin-based chemotherapy', 'basal/squamous-like (BASQ', 'Atezolizumab', 'neoadjuvant atezolizumab', 'luminal type (KRT5/6-KRT14-FOXA1+GATA3+) and basal type (KRT5/6+KRT14+FOXA1-GATA3', 'atezolizumab', 'neoadjuvant atezolizumab treatment']","['1-year progression-free survival difference', 'objective pathological responses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C4708800', 'cui_str': '950'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1307598', 'cui_str': 'GATA3 protein, human'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]",,0.0514544,"This trial investigates the effectiveness of basal/squamous-like (BASQ) classification in the selection of an effective target group of patients with muscle-invasive bladder cancer (MIBC) for neoadjuvant atezolizumab treatment.
","[{'ForeName': 'Hyeong Dong', 'Initials': 'HD', 'LastName': 'Yuk', 'Affiliation': 'Urology, Seoul National University Hospital, Seoul, The Republic of Korea.'}, {'ForeName': 'Chang Wook', 'Initials': 'CW', 'LastName': 'Jeong', 'Affiliation': 'Urology, Seoul National University Hospital, Seoul, The Republic of Korea.'}, {'ForeName': 'Cheol', 'Initials': 'C', 'LastName': 'Kwak', 'Affiliation': 'Urology, Seoul National University Hospital, Seoul, The Republic of Korea.'}, {'ForeName': 'Hyeon', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Urology, Seoul National University Hospital, Seoul, The Republic of Korea.'}, {'ForeName': 'Kyung Chul', 'Initials': 'KC', 'LastName': 'Moon', 'Affiliation': 'College of Medicine, Seoul National University, Seoul, The Republic of Korea.'}, {'ForeName': 'Ja Hyeon', 'Initials': 'JH', 'LastName': 'Ku', 'Affiliation': 'Urology, Seoul National University Hospital, Seoul, The Republic of Korea kuuro70@snu.ac.kr.'}]",BMJ open,['10.1136/bmjopen-2019-035530']
2855,33060092,Cluster-randomised trial of community-based screening for eye disease in adults in Nepal: the Village-Integrated Eye Worker Trial II (VIEW II) trial protocol.,"INTRODUCTION


The majority of blindness worldwide could be prevented or reversed with early diagnosis and treatment, yet identifying at-risk and prevalent cases of eye disease and linking them with care remain important obstacles to addressing this burden. Leading causes of blindness like glaucoma, diabetic retinopathy and age-related macular degeneration have detectable early asymptomatic phases and can cause irreversible vision loss. Mass screening for such diseases could reduce visual impairment at the population level.
METHODS AND ANALYSIS


This protocol describes a parallel-group cluster-randomised trial designed to determine whether community-based screening for glaucoma, diabetic retinopathy and age-related macular degeneration reduces population-level visual impairment in Nepal. A door-to-door population census is conducted in all study communities. All adults aged ≥60 years have visual acuity tested at the census visit, and those meeting referral criteria are referred to a local eye care facility for further diagnosis and management. Communities are subsequently randomised to a community-based screening programme or to no additional intervention. The intervention consists of a single round of screening including intraocular pressure and optical coherence tomography assessment of all adults ≥60 years old with enhanced linkage to care for participants meeting referral criteria. Four years after implementation of the intervention, masked outcome assessors conduct a repeat census to collect data on the primary outcome, visual acuity. Individuals with incident visual impairment receive a comprehensive ophthalmological examination to determine the cause of visual impairment. Outcomes are compared by treatment arm according to the originally assigned intervention.
ETHICS AND DISSEMINATION


The trial has received ethical approval from the University of California San Francisco Institutional Review Board, Nepal Netra Jyoti Sangh and the Nepal Health Research Council. Results of this trial will be disseminated through publication in peer-reviewed journals and presentation at local and international meetings.
TRIAL REGISTRATION NUMBER


NCT03752840.",2020,"Leading causes of blindness like glaucoma, diabetic retinopathy and age-related macular degeneration have detectable early asymptomatic phases and can cause irreversible vision loss.","['All adults aged ≥60 years have visual acuity tested at the census visit, and those meeting referral criteria are referred to a local eye care facility for further diagnosis and management', 'all adults ≥60 years old with enhanced linkage to care for participants meeting referral criteria', 'Individuals with incident visual impairment', 'adults in Nepal', 'for glaucoma, diabetic retinopathy and age-related macular degeneration reduces population-level visual impairment in Nepal']","['community-based screening', 'single round of screening including intraocular pressure and optical coherence tomography assessment of']",['visual acuity'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0200150', 'cui_str': 'Visual acuity testing'}, {'cui': 'C0007663', 'cui_str': 'Census'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0885957', 'cui_str': 'Eye care'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0024437', 'cui_str': 'Degenerative disorder of macula'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",,0.404081,"Leading causes of blindness like glaucoma, diabetic retinopathy and age-related macular degeneration have detectable early asymptomatic phases and can cause irreversible vision loss.","[{'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Valerie M', 'Initials': 'VM', 'LastName': 'Stevens', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Raghunandan', 'Initials': 'R', 'LastName': 'Byanju', 'Affiliation': 'Bharatpur Eye Hospital, Bharatpur, Nepal.'}, {'ForeName': 'Ram Prasad', 'Initials': 'RP', 'LastName': 'Kandel', 'Affiliation': 'Seva Foundation, Bharatpur, Nepal.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Bhandari', 'Affiliation': 'Bharatpur Eye Hospital, Bharatpur, Nepal.'}, {'ForeName': 'Sadhan', 'Initials': 'S', 'LastName': 'Bhandari', 'Affiliation': 'Bharatpur Eye Hospital, Bharatpur, Nepal.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Melo', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California, USA jeremy.keenan@ucsf.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-040219']
2856,33060126,Effect of BATHE interview technique on patient satisfaction in an ambulatory family medicine centre in South India.,"OBJECTIVE


The objective of the study is to determine the effect of background, affect, trouble, handling and empathy (BATHE) versus usual interview technique on patient satisfaction during regular consultation with family physicians in ambulatory care.
DESIGN


The research design was a prospective, randomised control trial.
SETTING


The trial took place in a family practice unit in South India, which was one of the clinical service units of the academic Department of Family Medicine of a tertiary hospital.
PARTICIPANT


The eligible participants were adults above the age of 18 years, who did not have any acute presenting illness. The participants should have given consent and also not have any cognitive disability. A total of 138 participants took part in the trial, 70 in BATHE group and 68 in the non-BATHE group. All participants entering the trial completed the questionnaire.
RESULT


The BATHE group had a significantly higher mean score for questions grouped under professional satisfaction. This included questions on whether the patient felt that the physician treated them as a person and also whether they felt the appropriate clinical examination was communicated to them. The questionnaire used for scoring satisfaction had 18 questions with a maximum possible score of 90. When taking a cut-off of 75% (68) from the total possible score of 90, 72.9% (51) of the participants for whom the BATHE consultation technique was used were satisfied as compared with only 55.9% (30) for whom the routine consultation was carried out. This was statistically significant (χ 2 =11.15, p value=0.0006) CONCLUSION: The study suggests that using BATHE in this family practice centre is beneficial in improving the perception of person centeredness in the consultation. However, further studies ruling out all possible bias are needed in our setting before the range of probable benefits of the BATHE technique can be fully gauged.",2020,The BATHE group had a significantly higher mean score for questions grouped under professional satisfaction.,"['The trial took place in a family practice unit in South India, which was one of the clinical service units of the academic Department of Family Medicine of a tertiary hospital', 'patient satisfaction in an ambulatory family medicine centre in South India', 'eligible participants were adults above the age of 18 years, who did not have any acute presenting illness', 'patient satisfaction during regular consultation with family physicians in ambulatory care', '138 participants took part in the trial, 70 in BATHE group and 68 in the non-BATHE group']",['usual interview technique'],[],"[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],138.0,0.0481547,The BATHE group had a significantly higher mean score for questions grouped under professional satisfaction.,"[{'ForeName': 'Navnee', 'Initials': 'N', 'LastName': 'Chengappa', 'Affiliation': 'Department of Family Medicine, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Prince Christopher', 'Initials': 'PC', 'LastName': 'Rajkumar Honest', 'Affiliation': 'Department of Family Medicine, Christian Medical College, Vellore, Tamil Nadu, India prince.christopher@gmail.com.'}, {'ForeName': 'Kirubah', 'Initials': 'K', 'LastName': 'David', 'Affiliation': 'Department of Family Medicine, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Ruby Angeline', 'Initials': 'RA', 'LastName': 'Pricilla', 'Affiliation': 'Department of Community Medicine, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Sajitha Mf', 'Initials': 'SM', 'LastName': 'Rahman', 'Affiliation': 'Department of Family Medicine, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Rebecca', 'Affiliation': 'Department of Biostatistics, Christian Medical College, Vellore, Tamil Nadu, India.'}]",Family medicine and community health,['10.1136/fmch-2020-000327']
2857,33060258,Aerosolized Calfactant for Newborns With Respiratory Distress: A Randomized Trial.,"BACKGROUND


Exogenous surfactants to treat respiratory distress syndrome (RDS) are approved for tracheal instillation only; this requires intubation, often followed by positive pressure ventilation to promote distribution. Aerosol delivery offers a safer alternative, but clinical studies have had mixed results. We hypothesized that efficient aerosolization of a surfactant with low viscosity, early in the course of RDS, could reduce the need for intubation and instillation of liquid surfactant.
METHODS


A prospective, multicenter, randomized, unblinded comparison trial of aerosolized calfactant (Infasurf) in newborns with signs of RDS that required noninvasive respiratory support. Calfactant was aerosolized by using a Solarys nebulizer modified with a pacifier adapter; 6 mL/kg (210 mg phospholipid/kg body weight) were delivered directly into the mouth. Infants in the aerosol group received up to 3 treatments, at least 4 hours apart. Infants in the control group received usual care, determined by providers. Infants were intubated and given instilled surfactant for persistent or worsening respiratory distress, at their providers' discretion.
RESULTS


Among 22 NICUs, 457 infants were enrolled; gestation 23 to 41 (median 33) weeks and birth weight 595 to 4802 (median 1960) grams. In total, 230 infants were randomly assigned to aerosol; 225 received 334 treatments, starting at a median of 5 hours. The rates of intubation for surfactant instillation were 26% in the aerosol group and 50% in the usual care group ( P  < .0001). Respiratory outcomes up to 28 days of age were no different.
CONCLUSIONS


In newborns with early, mild to moderate respiratory distress, aerosolized calfactant at a dose of 210 mg phospholipid/kg body weight reduced intubation and surfactant instillation by nearly one-half.",2020,The rates of intubation for surfactant instillation were 26% in the aerosol group and 50% in the usual care group ( P  < .0001).,"['Newborns With Respiratory Distress', '230 infants', 'Among 22 NICUs, 457 infants were enrolled; gestation 23 to 41 (median 33) weeks and birth weight 595 to 4802 (median 1960) grams', 'newborns with signs of RDS that required noninvasive respiratory support']","['Aerosolized Calfactant', 'aerosolized calfactant (Infasurf', 'instilled surfactant']",['rates of intubation for surfactant instillation'],"[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C5191367', 'cui_str': '595'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0763530', 'cui_str': 'calfactant'}, {'cui': 'C0763529', 'cui_str': 'Infasurf'}, {'cui': 'C1720298', 'cui_str': 'Instill'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}]",230.0,0.161211,The rates of intubation for surfactant instillation were 26% in the aerosol group and 50% in the usual care group ( P  < .0001).,"[{'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Cummings', 'Affiliation': 'Albany Medical Center, Albany, New York; cummings.AMBI@gmail.com.'}, {'ForeName': 'Erick', 'Initials': 'E', 'LastName': 'Gerday', 'Affiliation': 'Utah Valley Regional Medical Center, Provo, Utah.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Minton', 'Affiliation': 'Utah Valley Regional Medical Center, Provo, Utah.'}, {'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Katheria', 'Affiliation': 'Sharp Mary Birch Hospital for Women and Newborns, San Diego, California.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Albert', 'Affiliation': 'Sisters of Charity Hospital, Buffalo, New York.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Flores-Torres', 'Affiliation': 'Tampa General Hospital, Tampa, Florida.'}, {'ForeName': 'Mobolaji', 'Initials': 'M', 'LastName': 'Famuyide', 'Affiliation': 'Department of Pediatrics, University of Mississippi, Oxford, Mississippi.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lampland', 'Affiliation': ""Children's Minnesota St. Paul Hospital, St. Paul, Minnesota.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Guthrie', 'Affiliation': 'Jackson-Madison County General Hospital, Jackson, Tennessee.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Kuehn', 'Affiliation': 'East Carolina University and Vidant Medical Center, Greenville, North Carolina.'}, {'ForeName': 'Jörn-Hendrik', 'Initials': 'JH', 'LastName': 'Weitkamp', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Fort', 'Affiliation': ""Johns Hopkins All Children's Hospital, St. Petersburg, Florida.""}, {'ForeName': 'Elie G', 'Initials': 'EG', 'LastName': 'Abu Jawdeh', 'Affiliation': ""University of Kentucky Children's Hospital, Lexington, Kentucky.""}, {'ForeName': 'Rita M', 'Initials': 'RM', 'LastName': 'Ryan', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Gregory C', 'Initials': 'GC', 'LastName': 'Martin', 'Affiliation': ""Phoenix Children's Hospital, Phoenix, Arizona.""}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Swanson', 'Affiliation': ""University of Virginia Children's Hospital, Charlottesville, Virginia.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Mulrooney', 'Affiliation': ""Children's Minneapolis Hospital, Minneapolis, Minnesota.""}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Eyal', 'Affiliation': ""University of South Alabama Children's and Women's Hospital, Mobile, Alabama.""}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Gerstmann', 'Affiliation': 'Timpanogos Regional Hospital, Orem, Utah.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': ""Order of St. Francis Children's Hospital of Illinois, Peoria, Illinois.""}, {'ForeName': 'Greg E', 'Initials': 'GE', 'LastName': 'Wilding', 'Affiliation': 'Department of Biostatistics, University at Buffalo, Buffalo, New York; and.'}, {'ForeName': 'Edmund A', 'Initials': 'EA', 'LastName': 'Egan', 'Affiliation': 'ONY Biotech, Amherst, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatrics,['10.1542/peds.2019-3967']
2858,33060370,Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis.,"BACKGROUND


Psoriasis is a chronic inflammatory skin disease, affecting about 0.6% of the Chinese population. Many patients are not well controlled by conventional treatments, thus there is need for new treatment regimens. In this study, we assessed the efficacy and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis.
METHODS


This study was a 52-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 trial. A sub-population of study participants (≥18 years) of Chinese ethnicity were randomized to receive subcutaneous injections of 300 or 150 mg secukinumab, or placebo. The co-primary endpoints were psoriasis area severity index (PASI) 75 and Investigator's Global Assessment (IGA) 0/1 at Week 12.
RESULTS


A total of 441 Chinese patients were enrolled in this study. Co-primary outcomes were achieved; 300 and 150 mg secukinumab were superior to placebo as shown in the proportion of patients that achieved PASI 75 (97.7% and 87.2% vs. 3.7%, respectively; P < 0.001), and IGA 0/1 (82.3% and 69.7% vs. 2.7%; P < 0.001) at Week 12. Treatment efficacy was maintained until Week 52. There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period.
CONCLUSION


Secukinumab is highly effective and well tolerated in Chinese patients with moderate to severe plaque psoriasis.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03066609; https://clinicaltrials.gov/ct2/show/record/NCT03066609.",2020,"There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period.
","['A sub-population of study participants (≥18 years) of Chinese ethnicity', '441 Chinese patients', 'Chinese patients with moderate to severe plaque psoriasis']","['Secukinumab', 'placebo', 'secukinumab', 'subcutaneous injections of 300 or 150 mg secukinumab, or placebo']","['efficacy and safety', 'psoriasis area severity index (PASI', 'overall adverse events', 'Treatment efficacy']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",441.0,0.59253,"There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period.
","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': ""Department of Dermatology, Peking University People's Hospital, Beijing 100044, China.""}, {'ForeName': 'Jian-Zhong', 'Initials': 'JZ', 'LastName': 'Zhang', 'Affiliation': ""Department of Dermatology, Peking University People's Hospital, Beijing 100044, China.""}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Yao', 'Affiliation': 'Institute of Dermatology, Chinese Academy of Medical Science & Peking Union Medical College, Beijing 100730, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Department of Dermatology, Changhai Hospital, Shanghai 200433, China.'}, {'ForeName': 'Quan-Zhong', 'Initials': 'QZ', 'LastName': 'Liu', 'Affiliation': 'Department of Dermatology, Tianjin Medical University General Hospital, Tianjin 300052, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Department of Dermatology, Second Affiliated Hospital School of Medicine, Zhejiang University, Hangzhou, Zhejiang 311215, China.'}, {'ForeName': 'Shi-Fa', 'Initials': 'SF', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, General Hospital of Northern Theater Command, Shenyang, Liaoning 110016, China.'}, {'ForeName': 'Jin-Hua', 'Initials': 'JH', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'Cheng-Xin', 'Initials': 'CX', 'LastName': 'Li', 'Affiliation': ""Department of Dermatology and Venereology, Chinese People's Liberation Army General Hospital, Beijing 100853, China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Department of Dermatology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310016, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Dermatology, Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong 510120, China.'}, {'ForeName': 'Wei-Li', 'Initials': 'WL', 'LastName': 'Pan', 'Affiliation': ""Department of Dermatology, Zhejiang Provincial People's Hospital, Zhejiang, Hangzhou, Zhejiang 310014, China.""}, {'ForeName': 'Shen-Qiu', 'Initials': 'SQ', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Ruo-Yu', 'Initials': 'RY', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Peking University First Hospital, Beijing 100034, China.'}, {'ForeName': 'Zai-Pei', 'Initials': 'ZP', 'LastName': 'Guo', 'Affiliation': 'Department of Dermatology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China.'}, {'ForeName': 'Zhi-Qi', 'Initials': 'ZQ', 'LastName': 'Song', 'Affiliation': 'Department of Dermatology, First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116011, China.'}, {'ForeName': 'Shan-Shan', 'Initials': 'SS', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, The First Hospital of Jilin University, Changchun, Jilin 130021, China.'}, {'ForeName': 'Xiu-Qin', 'Initials': 'XQ', 'LastName': 'Dong', 'Affiliation': 'Department of Dermatology, Guangdong General Hospital, Guangzhou, Guangdong 510080, China.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Beijing Novartis Pharma Co. Ltd., Shanghai 201203, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Fu', 'Affiliation': 'Beijing Novartis Pharma Co. Ltd., Shanghai 201203, China.'}, {'ForeName': 'Pascaline', 'Initials': 'P', 'LastName': 'Regnault', 'Affiliation': 'Novartis Pharma AG, Basel 6463, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Charef', 'Affiliation': 'Novartis Pharma AG, Basel 6463, Switzerland.'}, {'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Mazur', 'Affiliation': 'Novartis Pharma AG, Basel 6463, Switzerland.'}, {'ForeName': 'Manmath', 'Initials': 'M', 'LastName': 'Patekar', 'Affiliation': 'Novartis Pharma AG, Basel 6463, Switzerland.'}]",Chinese medical journal,['10.1097/CM9.0000000000001163']
2859,33060472,Comparison of the rotational stability between plate-haptic toric and C-loop haptic toric IOLs in myopic eyes.,"PURPOSE


To compare the rotational stability of a plate-haptic toric intraocular lens (IOL) vs a C-loop haptic toric IOL in myopic cataract eyes.
SETTING


Eye and Ear, Nose, and Throat Hospital of Fudan University, China.
DESIGN


Prospective, randomized, controlled study.
METHODS


Cataract eyes with axial length (AL) more than 24.5 mm were randomly assigned to receive implantation of a C-loop haptic toric IOL (AcrySof Toric IOL) (Group A) or a plate-haptic toric IOL (AT TORBI 709M IOL) (Group B). IOL rotation, residual astigmatism, visual acuity, and higher-order aberrations (HOAs) evaluated with OPD-Scan III aberrometer were compared at 3 months postoperatively.
RESULTS


In total, 62 eyes of 62 patients were eligible for analysis: 31 in Group A and 31 in Group B. The mean rotation of toric IOLs was greater in Group A than that in Group B (8.00 ± 3.60 degrees vs 4.42 ± 3.24 degrees, respectively, P < .001), especially when IOLs were vertically placed. IOL rotation was positively correlated with AL in Group A, whereas no such correlations were found in Group B. Residual astigmatism in Group A was greater than that in Group B (-0.76 ± 0.30 diopter [D] vs -0.51 ± 0.29 D, respectively, P = .001). Fewer eyes achieved residual astigmatism of 0.50 D or less in Group A than in Group B (38.71% vs 64.52%). Group A had worse postoperative uncorrected visual acuity and higher total HOAs and coma for a 6.0 mm pupil than Group B, whereas postoperative corrected visual acuity was not different between the 2 groups.
CONCLUSIONS


The plate-haptic toric IOL might be a better choice for myopic cataract eyes with corneal astigmatism because of reduced postoperative rotation.",2020,Fewer eyes achieved residual astigmatism of 0.50 D or less in Group A than in Group B (38.71% vs 64.52%).,"['Eye and Ear, Nose, and Throat Hospital of Fudan University, China', 'myopic cataract eyes', 'Cataract eyes with axial length (AL', 'myopic eyes', 'In total, 62 eyes of 62 patients were eligible for analysis: 31 in Group A and 31 in Group B']","['implantation of a C-loop haptic toric IOL (AcrySof Toric IOL) (Group A) or a plate-haptic toric IOL (AT TORBI 709M IOL', 'plate-haptic toric and C-loop haptic toric IOLs', 'plate-haptic toric intraocular lens (IOL) vs a C-loop haptic toric IOL']","['mean rotation of toric IOLs', 'residual astigmatism', 'IOL rotation, residual astigmatism, visual acuity, and higher-order aberrations (HOAs) evaluated with OPD-Scan III aberrometer', 'postoperative uncorrected visual acuity and higher total HOAs and coma', 'IOL rotation', 'postoperative corrected visual acuity']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C3203722', 'cui_str': 'Residual astigmatism'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1532954', 'cui_str': 'Wavefront analyzer'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]",62.0,0.0896041,Fewer eyes achieved residual astigmatism of 0.50 D or less in Group A than in Group B (38.71% vs 64.52%).,"[{'ForeName': 'Xiangjia', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'From the Eye Institute, Eye and Ear, Nose, and Throat Hospital of Fudan University (Zhu, Meng, He, Rong, Lu), Key Laboratory of Myopia, Ministry of Health (Zhu, He, Lu), Key Laboratory of Visual Impairment and Restoration (Zhu, He, Lu), Key NHC key Laboratory of Myopia, Fudan University (Zhu, He, Lu), and Laboratory of Myopia, Chinese Academy of Medical Sciences (Zhu, He, Lu), Shanghai, China.'}, {'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Meng', 'Affiliation': ''}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Xianfang', 'Initials': 'X', 'LastName': 'Rong', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000259']
2860,33060490,The Effect of Mechanical Ventilation With Low Tidal Volume on Blood Loss During Laparoscopic Liver Resection: A Randomized Controlled Trial.,"BACKGROUND


Control of bleeding during laparoscopic liver resection (LLR) is important for patient safety. It remains unknown what the effects of mechanical ventilation with varying tidal volumes on bleeding during LLR. Thus, this study aims to investigate whether mechanical ventilation with low tidal volume (LTV) reduces surgical bleeding during LLR.
METHODS


In this prospective, randomized, and controlled clinical study, 82 patients who underwent scheduled LLR were enrolled and randomly received either mechanical ventilation with LTV group (6-8 mL/kg) along with recruitment maneuver (once/30 min) without positive end-expiratory pressure (PEEP) or conventional tidal volume (CTV; 10-12 mL/kg) during parenchymal resection. The estimated volume of blood loss during parenchymal resection and the incidence of postoperative respiratory complications were compared between 2 groups.
RESULT


The estimated volume of blood loss (median [interquartile range {IQR}]) was decreased in the LTV group compared to the CTV group (301 [148, 402] vs 394 [244, 672] mL, P = .009); blood loss per cm of transected surface of liver (5.5 [4.1, 7.7] vs 12.2 [9.8, 14.4] mL/cm, P < .001) and the risk of clinically significant estimated blood loss (>800 mL) were reduced in the LTV group compared to the CTV group (0/40 vs 8/40, P = .003). Blood transfusion was decreased in the LTV group compared to the CTV group (5% vs 20% of patients , P = .043). No patient in the LTV group but 2 patients in the CTV group were switched from LLR to open hepatectomy. Airway plateau pressure was lower in the LTV group compared to the CTV group (mean ± standard deviation [SD]) (12.7 ± 2.4 vs 17.5 ± 3.5 cm H2O, P = .002).
CONCLUSIONS


Mechanical ventilation with LTV may reduce bleeding during laparoscopic liver surgery.",2020,"Blood transfusion was decreased in the LTV group compared to the CTV group (5% vs 20% of patients , P = .043).",['82 patients who underwent scheduled LLR'],"['mechanical ventilation with low tidal volume (LTV', 'mechanical ventilation with LTV group (6-8 mL/kg) along with recruitment maneuver (once/30 min) without positive end-expiratory pressure (PEEP) or conventional tidal volume (CTV; 10-12 mL/kg) during parenchymal resection', 'Laparoscopic Liver Resection', 'Mechanical Ventilation With Low Tidal Volume', 'CTV', 'LTV', 'laparoscopic liver resection (LLR']","['blood loss per cm of transected surface of liver', 'Airway plateau pressure', 'Blood transfusion', 'estimated volume of blood loss (median [interquartile range {IQR', 'postoperative respiratory complications', 'Blood Loss', 'blood loss', 'bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0458922', 'cui_str': 'Surface of liver'}, {'cui': 'C3697386', 'cui_str': 'Airway plateau pressure'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}]",82.0,0.168023,"Blood transfusion was decreased in the LTV group compared to the CTV group (5% vs 20% of patients , P = .043).","[{'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Hepatology, Southwest Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Shuguo', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Hepatology, Southwest Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Kaizhi', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Daqing', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Division of Anaesthetics, Pain Medicine and Intensive Care, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, Chelsea and Westminster Hospital, London, United Kingdom.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Chongqing University Cancer Hospital, Chongqing, China.'}, {'ForeName': 'Jiaolin', 'Initials': 'J', 'LastName': 'Ning', 'Affiliation': 'From the Department of Anesthesiology.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005242']
2861,33060491,"Influence of Levobupivacaine Regional Scalp Block on Hemodynamic Stability, Intra- and Postoperative Opioid Consumption in Supratentorial Craniotomies: A Randomized Controlled Trial.","BACKGROUND


The anesthetic management of supratentorial craniotomy (CR) necessitates tight intraoperative hemodynamic control. This type of surgery may also be associated with substantial postoperative pain. We aimed at evaluating the influence of regional scalp block (SB) on hemodynamic stability during the noxious events of supratentorial craniotomies and total intravenous anesthesia, its influence on intraoperative anesthetic agents' consumption, and its effect on postoperative pain control.
METHODS


Sixty patients scheduled for elective CR were prospectively enrolled. Patient, anesthesiologist, and neurosurgeon were blind to the random performance of SB with either levobupivacaine 0.33% (intervention group [group SB], n = 30) or the same volume of saline (control group [group CO], placebo group, n = 30). General anesthesia was induced and maintained using target-controlled infusions of remifentanil and propofol that were adjusted according to hemodynamic parameters and state entropy of the electroencephalogram (SE), respectively. Mean arterial blood pressure (MAP), heart rate (HR), SE, and propofol and remifentanil effect-site concentrations (Ce) were recorded at the time of scalp block performance (Baseline), and 0, 1, 3, and 5 minutes after skull-pin fixation (SP), skin incision (SI), CR, and dura-mater incision (DM). Morphine consumption and postoperative pain intensity (0-10 visual analog scale [VAS]) were recorded 1, 3, 6, 24, and 48 hours after surgery. Propofol and remifentanil overall infusion rates were also recorded. Data were analyzed using 2-tailed Student unpaired t tests, 2-way mixed-design analysis of variance (ANOVA), and Tukey's honestly significant difference (HSD) tests for post hoc comparisons as appropriate.
RESULTS


Demographics and length of anesthetic procedure of group CO and SB were comparable. SP, SI, and CR were associated with a significantly higher MAP in group CO than in group SB, at least at one of the time points of recording surrounding those noxious events. This was not the case at DM. Similarly, HR was significantly higher in group CO than in group SB during SP and SI, at least at 1 of the points of recording, but not during CR and DM. Propofol and remifentanil Ce and overall infusion rates were significantly higher in group CO than in group SB, except for propofol Ce during SP. Postoperative pain VAS and cumulative morphine consumption were significantly higher in group CO than in group SB.
CONCLUSIONS


In supratentorial craniotomies, SB improves hemodynamic control during noxious events and provides adequate and prolonged postoperative pain control as compared to placebo.",2020,"Propofol and remifentanil Ce and overall infusion rates were significantly higher in group CO than in group SB, except for propofol Ce during SP.","['Sixty patients scheduled for elective CR were prospectively enrolled', 'Supratentorial Craniotomies']","['supratentorial craniotomy (CR', 'Propofol and remifentanil Ce', 'saline (control group [group CO], placebo', 'regional scalp block (SB', 'remifentanil and propofol', 'placebo', 'levobupivacaine', 'Levobupivacaine Regional Scalp Block', 'Propofol']","['Mean arterial blood pressure (MAP), heart rate (HR), SE, and propofol and remifentanil effect-site concentrations (Ce', 'time of scalp block performance (Baseline), and 0, 1, 3, and 5 minutes after skull-pin fixation (SP), skin incision (SI), CR, and dura-mater incision (DM', 'Morphine consumption and postoperative pain intensity (0-10 visual analog scale [VAS', 'overall infusion rates', 'Hemodynamic Stability, Intra- and Postoperative Opioid Consumption', 'SP, SI, and CR', 'Postoperative pain VAS and cumulative morphine consumption', 'remifentanil overall infusion rates']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial'}]","[{'cui': 'C0441938', 'cui_str': 'Supratentorial'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0013313', 'cui_str': 'Dura mater structure'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",60.0,0.10874,"Propofol and remifentanil Ce and overall infusion rates were significantly higher in group CO than in group SB, except for propofol Ce during SP.","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Carella', 'Affiliation': 'From the Department of Anesthesia and Intensive Care Medicine, Liege University Hospital, Liege, Belgium.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Tran', 'Affiliation': 'From the Department of Anesthesia and Intensive Care Medicine, Liege University Hospital, Liege, Belgium.'}, {'ForeName': 'Vincent L', 'Initials': 'VL', 'LastName': 'Bonhomme', 'Affiliation': 'From the Department of Anesthesia and Intensive Care Medicine, Liege University Hospital, Liege, Belgium.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'Franssen', 'Affiliation': 'From the Department of Anesthesia and Intensive Care Medicine, Liege University Hospital, Liege, Belgium.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005230']
2862,33060493,"Epidural Administration of Ropivacaine Reduces the Amplitude of Transcranial Electrical Motor-Evoked Potentials: A Double-Blinded, Randomized, Controlled Trial.","BACKGROUND


An epidurally administered local anesthetic acts primarily on the epidural nerve roots and can act directly on the spinal cord through the dural sleeve. We hypothesized that epidurally administered ropivacaine would reduce the amplitude of transcranial electrical motor-evoked potentials by blocking nerve conduction in the spinal cord. Therefore, we conducted a double-blind, randomized, controlled trial.
METHODS


Thirty adult patients who underwent lung surgery were randomly allocated to 1 of 3 groups, based on the ropivacaine concentration: the 0.2% group, the 0.375% group, and the 0.75% group. The attending anesthesiologists, neurophysiologists, and patients were blinded to the allocation. The epidural catheter was inserted at the T5-6 or T6-7 interspace by a paramedian approach, using the loss of resistance technique with normal saline. General anesthesia was induced and maintained using propofol and remifentanil. Transcranial electrical motor-evoked potentials were elicited by a train of 5 pulses with an interstimulus interval of 2 milliseconds by using a constant-voltage stimulator and were recorded from the tibialis anterior muscle. Somatosensory-evoked potentials (SSEPs) were evoked by electrical tibial nerve stimulation at the popliteal fossa. After measuring the baseline values of these evoked potentials, 10 mL of epidural ropivacaine was administered at the 0.2%, 0.375%, or 0.75% concentration. The baseline amplitudes and latencies recorded before administering ropivacaine were defined as 100%. Our primary end point was the relative amplitude of the motor-evoked potentials at 60 minutes after the epidural administration of ropivacaine. We analyzed the amplitudes and latencies of these evoked potentials by using the Kruskal-Wallis test and used the Dunn multiple comparison test as the post hoc test for statistical analysis.
RESULTS


The data are expressed as the median (interquartile range). Sixty minutes after epidurally administering ropivacaine, the motor-evoked potential amplitude was lower in the 0.75% group (7% [3%-18%], between-group difference P < .001) and in the 0.375% group (52% [43%-59%]) compared to that in the 0.2% group (96% [89%-105%]). The latency of SSEP was longer in the 0.75% group compared to that in the 0.2% group, but the amplitude was unaffected.
CONCLUSIONS


Epidurally administered high-dose ropivacaine lowered the amplitude of motor-evoked potentials and prolonged the onset latencies of motor-evoked potentials and SSEPs compared to those in the low-dose group. High-dose ropivacaine can act on the motor pathway through the dura mater.",2020,We hypothesized that epidurally administered ropivacaine would reduce the amplitude of transcranial electrical motor-evoked potentials by blocking nerve conduction in the spinal cord.,['Thirty adult patients who underwent lung surgery'],"['ropivacaine', 'propofol and remifentanil', 'epidural ropivacaine', 'Ropivacaine', 'Somatosensory-evoked potentials (SSEPs']","['Amplitude of Transcranial Electrical Motor-Evoked Potentials', 'relative amplitude of the motor-evoked potentials', 'onset latencies of motor-evoked potentials and SSEPs', 'latency of SSEP', 'motor-evoked potential amplitude', 'amplitude of motor-evoked potentials']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038903', 'cui_str': 'Operation on lung'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}]","[{'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}]",30.0,0.163123,We hypothesized that epidurally administered ropivacaine would reduce the amplitude of transcranial electrical motor-evoked potentials by blocking nerve conduction in the spinal cord.,"[{'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Furutani', 'Affiliation': 'From the Department of Anesthesiology, Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Tobita', 'Affiliation': 'Department of Anesthesiology, Saiseikai Niigata Hospital, Niigata, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Ishii', 'Affiliation': 'Department of Anesthesiology, Nagaoka Chuo General Hospital, Nagaoka City, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Deguchi', 'Affiliation': 'From the Department of Anesthesiology, Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Mitsuma', 'Affiliation': 'From the Department of Anesthesiology, Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Kamiya', 'Affiliation': 'From the Department of Anesthesiology, Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': 'From the Department of Anesthesiology, Niigata University Medical and Dental Hospital, Niigata, Japan.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005236']
2863,33060547,Central and Peripheral Postexercise Blood Pressure and Vascular Responses in Young Adults with Obesity.,"INTRODUCTION


Adults with obesity are at an increased risk of incident hypertension. Regular aerobic exercise is recommended for the prevention and treatment of hypertension, but whether young adults with obesity exhibit impaired post-exercise blood pressure (BP) and vascular responses remains unclear.
PURPOSE


We tested the hypothesis that young adults with obesity exhibit attenuated post-exercise hypotension (PEH) and post-exercise peripheral vasodilation compared with young adults without obesity.
METHODS


Thirty-six normotensive adults without and with obesity (11 males and 7 females per group) underwent measurements of brachial and central BP, and leg blood flow (Doppler ultrasound) at baseline, and 30-min, 60-min, and 90-min following acute one-hour moderate-intensity cycling. Leg vascular conductance (LVC) was calculated as flow/mean arterial pressure (MAP).
RESULTS


Both groups exhibited similar brachial and central PEH (peak change from baseline: -2 mm Hg and -4 mm Hg for brachial and central systolic BPs, respectively, for both groups) (time effect: p<0.05). Both groups also exhibited post-exercise peripheral vasodilation, assessed via LVC (time effect: p<0.05), but its overall magnitude was smaller in young adults with obesity (LVC change from baseline: +47 ± 37%, +29 ± 36%, and +20 ± 29%) compared with young adults without obesity (LVC change from baseline: +88 ± 58%, +59 ± 54%, and +42 ± 51%) (group effect: p<0.05).
CONCLUSION


Although obesity did not impair PEH after acute moderate-intensity exercise, young adults with obesity exhibited smaller post-exercise peripheral vasodilation compared with young adults without obesity. Collectively, these findings have identified evidence for obesity-induced alterations in the peripheral vasculature following exercise.",2020,"Both groups also exhibited post-exercise peripheral vasodilation, assessed via LVC (time effect: p<0.05), but its overall magnitude was smaller in young adults with obesity (LVC change from baseline: +47 ± 37%, +29 ± 36%, and +20 ± 29%) compared with young adults without obesity (LVC change from baseline: +88 ± 58%, +59 ± 54%, and +42 ± 51%) (group effect: p<0.05).
","['Young Adults with Obesity', 'Thirty-six normotensive adults without and with obesity (11 males and 7 females per group', 'young adults with obesity exhibit attenuated post']","['exercise hypotension (PEH) and post-exercise peripheral vasodilation', 'Regular aerobic exercise']","['brachial and central PEH', 'Central and Peripheral Postexercise Blood Pressure and Vascular Responses', 'brachial and central BP, and leg blood flow (Doppler ultrasound', 'Leg vascular conductance (LVC', 'flow/mean arterial pressure (MAP']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C2936233', 'cui_str': 'Post Exercise Hypotension'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C2936233', 'cui_str': 'Post Exercise Hypotension'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",36.0,0.170612,"Both groups also exhibited post-exercise peripheral vasodilation, assessed via LVC (time effect: p<0.05), but its overall magnitude was smaller in young adults with obesity (LVC change from baseline: +47 ± 37%, +29 ± 36%, and +20 ± 29%) compared with young adults without obesity (LVC change from baseline: +88 ± 58%, +59 ± 54%, and +42 ± 51%) (group effect: p<0.05).
","[{'ForeName': 'Kanokwan', 'Initials': 'K', 'LastName': 'Bunsawat', 'Affiliation': 'Integrative Physiology Laboratory, Department of Kinesiology and Nutrition, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Lefferts', 'Affiliation': 'Integrative Physiology Laboratory, Department of Kinesiology and Nutrition, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Grigoriadis', 'Affiliation': 'Integrative Physiology Laboratory, Department of Kinesiology and Nutrition, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Sang Ouk', 'Initials': 'SO', 'LastName': 'Wee', 'Affiliation': 'Integrative Physiology Laboratory, Department of Kinesiology and Nutrition, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Kilianek', 'Affiliation': 'Integrative Physiology Laboratory, Department of Kinesiology and Nutrition, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Fadel', 'Affiliation': 'Department of Kinesiology, College of Nursing and Health Innovation, University of Texas at Arlington, Arlington, TX.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Clifford', 'Affiliation': 'Integrative Physiology Laboratory, Department of Kinesiology and Nutrition, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Fernhall', 'Affiliation': 'Integrative Physiology Laboratory, Department of Kinesiology and Nutrition, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Baynard', 'Affiliation': 'Integrative Physiology Laboratory, Department of Kinesiology and Nutrition, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002540']
2864,33060548,Short- and Long-Term Stroboscopic Training Effects on Visuomotor Performance in Elite Youth Sports. Part 1: Reaction and Behavior.,"PURPOSE


Recent research suggests that stroboscopic training is an effective tool to improve visual and visuomotor performance. However, many studies were limited by small samples, short training interventions, inexperienced athletes, and an exclusive focus on short-term effects. This first part of the study evaluates the short- and long-term effects of stroboscopic training on visuomotor reaction speed in elite athletes.
METHODS


45 young elite badminton athletes participated in this study, of which 32 (13.7 years) were included in the final data analysis. Participants were assigned to an intervention (stroboscopic vision) or control group (normal vision). Both groups performed identical badminton-specific training drills implemented into the regular training schedule. Prior to and after a 10-week training period and after a 6-week retention interval, athletes performed a laboratory reaction test to determine EMG onset and visuomotor reaction time (VMRT). In addition, a field test investigated stroboscopic training effects on the quality of ball-racquet contact and net drop performance, respectively.
RESULTS


VMRT decreased immediately after stroboscopic training (pre: 251 ms, post: 238 ms, p=0.005, d=0.63) and reactions remained significantly faster following the retention interval (retention: 241 ms, p=0.041, d=0.50). Analyses on EMG onset data suggested these adaptations were attributable to the pre-motor, rather than the motor time. VMRT remained unchanged in the control group (pre: 252 ms, post: 256, retention: 253 ms, p > 0.99). Field-test performance improvements were observed for the quality of ball-racquet contact and net drop performance, however changes were not different between groups.
CONCLUSION


Stroboscopic training induced short- and long-term accelerations of visuomotor reaction speed in elite badminton players. Stroboscopic eyewear may be an effective training tool to accelerate visuomotor reactions in highly skilled athletes.",2020,Stroboscopic training induced short- and long-term accelerations of visuomotor reaction speed in elite badminton players.,"['elite badminton players', 'elite athletes', 'highly skilled athletes', 'Elite Youth Sports', '45 young elite badminton athletes participated in this study, of which 32 (13.7 years) were included in the final data analysis']","['Short- and Long-Term Stroboscopic Training', 'intervention (stroboscopic vision) or control group (normal vision', 'stroboscopic training', 'Stroboscopic training']","['visuomotor reactions', 'EMG onset and visuomotor reaction time (VMRT', 'Visuomotor Performance', 'visuomotor reaction speed', 'visual and visuomotor performance', 'VMRT']","[{'cui': 'C0004678', 'cui_str': 'Badminton'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4042873', 'cui_str': 'Adolescent Sports'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234622', 'cui_str': 'Normal vision'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",45.0,0.0174445,Stroboscopic training induced short- and long-term accelerations of visuomotor reaction speed in elite badminton players.,"[{'ForeName': 'Thorben', 'Initials': 'T', 'LastName': 'Hülsdünker', 'Affiliation': 'Department of Exercise and Sport Science, LUNEX International University of Health, Exercise and Sports, Differdange, Luxembourg.'}, {'ForeName': 'Nadira', 'Initials': 'N', 'LastName': 'Gunasekara', 'Affiliation': 'Institute of Movement and Neurosciences, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mierau', 'Affiliation': 'Department of Exercise and Sport Science, LUNEX International University of Health, Exercise and Sports, Differdange, Luxembourg.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002541']
2865,33060549,Short- and Long-Term Stroboscopic Training Effects on Visuomotor Performance in Elite Youth Sports. Part 2: Brain-Behavior Mechanisms.,"PURPOSE


Stroboscopic training has repeatedly been shown to improve visuomotor abilities. However, although performance improvements were attributed to visual processes, information on the neurophysiological mechanisms is missing. Part 2 of this study investigated the effects of stroboscopic training on neural visual and motor functions and its contribution to training-induced changes in visuomotor reaction time.
METHODS


45 young elite badminton athletes participated in this study, of which 32 (13.7 years) were included in the final data analysis. Participants were assigned to an intervention (stroboscopic vision) or control group (normal vision). Prior to and after a 10-week training and following a 6-week retention period, participants performed visual perception and reaction tasks in response to visual motion stimuli. The N2 and N2-r motion onset visual evoked potentials, its linear combination (Vlc) and the BA6 negativity potential were determined using a 64-channel EEG.
RESULTS


A significant Time × Group effect was observed for the Vlc score (p=0.019, ηp =0.18) indicating a lower Vlc in the intervention group. However, post-hoc tests did not reach significance. Within-subject correlation analyses revealed changes in reaction speed were related to latency changes in N2 (r=0.59, p<0.001), N2-r (r=-0.64, p<0.001) and the combined Vlc (r=0.68, p<0.001). Regression analyses across participants including multiple (N2/N2-r) or single (Vlc) predictors provided an explained variance of >60% (N2/N2-r: r=0.62, Vlc: r=0.64). No training effects or correlations were observed for the BA6 negativity.
CONCLUSION


The results indicate faster visuomotor reactions following stroboscopic training are accompanied by accelerated visual perception and processing while motor processes seemed to be unaffected. Stroboscopic training may be promising to specifically address the visual system in visuomotor demanding sports.",2020,"A significant Time × Group effect was observed for the Vlc score (p=0.019, ηp =0.18) indicating a lower Vlc in the intervention group.","['Elite Youth Sports', '45 young elite badminton athletes participated in this study, of which 32 (13.7 years) were included in the final data analysis']","['Short- and Long-Term Stroboscopic Training', 'intervention (stroboscopic vision) or control group (normal vision', 'stroboscopic training', 'Stroboscopic training']","['Vlc score', 'visuomotor reaction time', 'N2 and N2-r motion onset visual evoked potentials, its linear combination (Vlc) and the BA6 negativity potential', 'visuomotor abilities', 'visuomotor reactions', 'neural visual and motor functions', 'Visuomotor Performance', 'reaction speed', 'BA6 negativity']","[{'cui': 'C4042873', 'cui_str': 'Adolescent Sports'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0004678', 'cui_str': 'Badminton'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234622', 'cui_str': 'Normal vision'}]","[{'cui': 'C0015217', 'cui_str': 'Visual evoked potential'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",45.0,0.018238,"A significant Time × Group effect was observed for the Vlc score (p=0.019, ηp =0.18) indicating a lower Vlc in the intervention group.","[{'ForeName': 'Thorben', 'Initials': 'T', 'LastName': 'Hülsdünker', 'Affiliation': 'Department of Exercise and Sport Science, LUNEX International University of Health, Exercise and Sports, Differdange, Luxembourg.'}, {'ForeName': 'Nadira', 'Initials': 'N', 'LastName': 'Gunasekara', 'Affiliation': 'Institute of Movement and Neurosciences, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mierau', 'Affiliation': 'Department of Exercise and Sport Science, LUNEX International University of Health, Exercise and Sports, Differdange, Luxembourg.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002543']
2866,33060555,"Comparison of Regularly Scheduled Ibuprofen Versus ""Pro Re Nata"" for Ankle Sprains in Children Treated in the Emergency Department: A Randomized Controlled Trial.","OBJECTIVE


We compared pain and degree of disability in patients with acute ankle sprains receiving regular scheduled ibuprofen versus pro re nata (PRN).
METHODS


This study is a randomized single-blinded controlled trial of children aged 7 to 17 years presenting with acute ankle sprain to an emergency department. Patients were randomized to receive 10 mg/kg of ibuprofen per dose (maximum 600 mg) every 6 hours regular scheduled versus PRN. Outcome measures included a 100-mm visual analog scale pain and degree of disability at day 4. A sample size of 72 children had a power of 80% to detect a clinically meaningful difference of 20 mm between the regular and PRN group.
RESULTS


We randomly assigned 99 patients to receive regular scheduled (n = 50) or PRN (n = 49) ibuprofen. Pain scores and degree of disability at day 4 showed no significant differences between groups. The rate of reported adverse effects was higher in the regular scheduled group (11.4% vs 9.5%) versus the PRN group.
CONCLUSIONS


Our study suggests that there is little benefit from routinely using a regular scheduled ibuprofen regimen for acute pediatric ankle sprains.",2020,Pain scores and degree of disability at day 4 showed no significant differences between groups.,"['children aged 7 to 17 years presenting with acute ankle sprain to an emergency department', 'Ankle Sprains in Children Treated in the Emergency Department', 'patients with acute ankle sprains receiving regular scheduled', 'acute pediatric ankle sprains', '99 patients to receive regular scheduled (n = 50) or']","['ibuprofen per dose (maximum 600 mg) every 6 hours regular scheduled versus PRN', 'ibuprofen versus pro re nata (PRN', 'Ibuprofen Versus ""Pro Re Nata', 'ibuprofen', 'PRN']","['100-mm visual analog scale pain and degree of disability at day 4', 'rate of reported adverse effects', 'pain and degree of disability', 'Pain scores and degree of disability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0585325', 'cui_str': 'Every six hours'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067792', 'cui_str': 'N-acetyltryptophanamide'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",99.0,0.259092,Pain scores and degree of disability at day 4 showed no significant differences between groups.,"[{'ForeName': 'Rodrick', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': 'From the Department of Paediatrics, Western University.'}, {'ForeName': 'Gurinder', 'Initials': 'G', 'LastName': 'Sangha', 'Affiliation': 'From the Department of Paediatrics, Western University.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Lepore', 'Affiliation': 'From the Department of Paediatrics, Western University.'}, {'ForeName': 'Katelyn M', 'Initials': 'KM', 'LastName': 'Bartlett', 'Affiliation': 'From the Department of Paediatrics, Western University.'}, {'ForeName': 'Jamie A', 'Initials': 'JA', 'LastName': 'Seabrook', 'Affiliation': 'From the Department of Paediatrics, Western University.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rieder', 'Affiliation': 'From the Department of Paediatrics, Western University.'}]",Pediatric emergency care,['10.1097/PEC.0000000000002282']
2867,32871043,Prognostic scoring system and risk stratification in patients with emphysematous pyelonephritis: an 11-year prospective study at a tertiary referral centre.,"OBJECTIVES


To define pre-morbid, clinical, laboratory, and imaging features and identify prognostic factors associated with morbidity and mortality in patients with emphysematous pyelonephritis (EPN) and develop a prognostic scoring system for improving management outcomes.
PATIENTS AND METHODS


From January 2009 to December 2019, we performed a prospective study of all patients with a suspected diagnosis of EPN referred to a specialist tertiary centre in South India. All patients who underwent non-contrast computed tomography of the abdomen and those diagnosed with EPN were included in this study. Demographic parameters, imaging, haematological and microbiology results were recorded. Patients were divided into three groups: Group 1, patients who survived without any intervention; Group 2, those who survived with surgical intervention; and Group 3, those who died with or without intervention. A prognostic scoring system was developed from 18 different parameters and risk stratification was developed. The scores were correlated with overall prognosis.
RESULTS


Data from 131 patients with EPN enrolled in the study were analysed: Group 1 (n = 22), Group 2 (n = 102) and Group 3 (n = 7). By using univariate analysis, 10 factors were identified to be significantly associated with prognosis. Diabetes mellitus was the most common comorbidity. Shock at initial admission indicated a poor prognosis and warranted immediate attention (P < 0.001).
CONCLUSIONS


A multi-disciplinary approach, a high index of clinical suspicion, an early diagnosis and administration of culture-specific antibiotics with identification of prognostic indicators and risk stratification, allows prompt and appropriate medical and surgical treatments that could improve EPN management outcomes.",2020,"Shock at initial admission indicated a poor prognosis and warranted immediate attention (P < 0.001).
","['131 patients with EPN enrolled in the study', 'From January 2009 to December 2019, we performed a prospective study of all patients with a suspected diagnosis of EPN referred to a specialist tertiary centre in South India', 'All patients who underwent non-contrast computed tomography of the abdomen and those diagnosed with EPN', 'patients with emphysematous pyelonephritis (EPN', 'patients with emphysematous pyelonephritis']",['surgical intervention'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0403379', 'cui_str': 'Emphysematous pyelonephritis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}]",[],131.0,0.0249649,"Shock at initial admission indicated a poor prognosis and warranted immediate attention (P < 0.001).
","[{'ForeName': 'Sriram', 'Initials': 'S', 'LastName': 'Krishnamoorthy', 'Affiliation': 'Department of Urology and Renal Transplantation, Sri Ramachandra Institute of Higher Education and Research, Chennai, India.'}, {'ForeName': 'Alimuddin', 'Initials': 'A', 'LastName': 'Zumla', 'Affiliation': 'Division of Infection and Immunity, Centre for Clinical Microbiology, University College London (UCL), London,, UK.'}, {'ForeName': 'Hariharasudhan', 'Initials': 'H', 'LastName': 'Sekar', 'Affiliation': 'Department of Urology and Renal Transplantation, Sri Ramachandra Institute of Higher Education and Research, Chennai, India.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Muneer', 'Affiliation': 'Division of Surgery and Interventional Science UCL, Department of Urology and NIHR Biomedical Research Centre, UCL Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Gayathri', 'Initials': 'G', 'LastName': 'Thiruvengadam', 'Affiliation': 'Department of Bio-Statistics, Faculty of Allied Health Science, Sri Ramachandra Institute of Higher Education & Research, Chennai, India.'}, {'ForeName': 'Natarajan', 'Initials': 'N', 'LastName': 'Kumaresan', 'Affiliation': 'Department of Urology and Renal Transplantation, Sri Ramachandra Institute of Higher Education and Research, Chennai, India.'}]",BJU international,['10.1111/bju.15225']
2868,32886005,Endothelial function and shear stress in hypobaric hypoxia: time course and impact of plasma volume expansion in men.,"High-altitude exposure typically reduces endothelial function, and this is modulated by hemoconcentration resulting from plasma volume contraction. However, the specific impact of hypobaric hypoxia independent of external factors (e.g., cold, varying altitudes, exercise, diet, and dehydration) on endothelial function is unknown. We examined the temporal changes in blood viscosity, shear stress, and endothelial function and the impact of plasma volume expansion (PVX) during exposure to hypobaric hypoxia while controlling for external factors. Eleven healthy men (25 ± 4 yr, mean ± SD) completed two 4-day chamber visits [normoxia (NX) and hypobaric hypoxia (HH; equivalent altitude, 3,500 m)] in a crossover design. Endothelial function was assessed via flow-mediated dilation in response to transient (reactive hyperemia; RH-FMD) and sustained (progressive handgrip exercise; SS-FMD) increases in shear stress before entering and after 1, 6, 12, 48, and 96 h in the chamber. During HH, endothelial function was also measured on the last day after PVX to preexposure levels (1,140 ± 320 mL balanced crystalloid solution). Blood viscosity and arterial shear stress increased on the first day during HH compared with NX and remained elevated at 48 and 96 h ( P  < 0.005). RH-FMD did not differ during HH compared with NX and was unaffected by PVX despite reductions in blood viscosity ( P  < 0.05). The stimulus-response slope of increases in shear stress to vasodilation during SS-FMD was preserved in HH and increased by 44 ± 73% following PVX ( P  = 0.023). These findings suggest that endothelial function is maintained in HH when other stressors are absent and that PVX improves endothelial function in a shear-stress stimulus-specific manner. NEW & NOTEWORTHY  Using a normoxic crossover study design, we examined the impact of hypobaric hypoxia (4 days; altitude equivalent, 3,500 m) and hemoconcentration on blood viscosity, shear stress, and endothelial function. Blood viscosity increased during the hypoxic exposure and was accompanied by elevated resting and exercising arterial shear stress. Flow-mediated dilation stimulated by reactive hyperemia and handgrip exercise was preserved throughout the hypoxic exposure. Plasma volume expansion reversed the hypoxia-associated hemoconcentration and selectively increased handgrip exercise flow-mediated dilation.",2020,RH-FMD did not differ during HH compared with NX and was unaffected by PVX despite reductions in blood viscosity ( P  < 0.05).,"['men', 'Eleven healthy men (25\u2009±\u20094 yr, mean\u2009±\u2009SD) completed two 4-day chamber visits [normoxia (NX) and hypobaric hypoxia (HH; equivalent altitude, 3,500 m', 'hypobaric hypoxia']","['hypobaric hypoxia (4 days; altitude equivalent, 3,500 m) and hemoconcentration', 'PVX']","['RH-FMD', 'elevated resting and exercising arterial shear stress', 'blood viscosity, shear stress, and endothelial function', 'blood viscosity, shear stress, and endothelial function and the impact of plasma volume expansion (PVX', 'Endothelial function and shear stress', 'handgrip exercise flow-mediated dilation', 'Endothelial function', 'reactive hyperemia and handgrip exercise', 'Blood viscosity and arterial shear stress', 'blood viscosity', 'Blood viscosity', 'endothelial function']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4552489', 'cui_str': 'Hypobaric hypoxia'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}]","[{'cui': 'C4552489', 'cui_str': 'Hypobaric hypoxia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0549409', 'cui_str': 'Hematocrit - PCV - high'}, {'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}]","[{'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005848', 'cui_str': 'Blood viscosity'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}]",11.0,0.0331321,RH-FMD did not differ during HH compared with NX and was unaffected by PVX despite reductions in blood viscosity ( P  < 0.05).,"[{'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Tremblay', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, University of British Columbia-Okanagan, Kelowna, Canada.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Ainslie', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, University of British Columbia-Okanagan, Kelowna, Canada.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Turner', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Bolzano, Italy.'}, {'ForeName': 'Hannes', 'Initials': 'H', 'LastName': 'Gatterer', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Bolzano, Italy.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Schlittler', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Bolzano, Italy.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Woyke', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Bolzano, Italy.'}, {'ForeName': 'Ivo B', 'Initials': 'IB', 'LastName': 'Regli', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Bolzano, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Strapazzon', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Bolzano, Italy.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Rauch', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Bolzano, Italy.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Siebenmann', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Bolzano, Italy.'}]",American journal of physiology. Heart and circulatory physiology,['10.1152/ajpheart.00597.2020']
2869,31234752,Adjustable compression wrap devices are cheaper and more effective than inelastic bandages for venous leg ulcer healing. A Multicentric Italian Randomized Clinical Experience.,,2020,,[],['inelastic bandages'],[],[],"[{'cui': 'C0004726', 'cui_str': 'Bandage'}]",[],,0.0137789,,"[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Mosti', 'Affiliation': 'Angiology Department, MD Barbantini Clinic, Lucca, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Mancini', 'Affiliation': 'Heart and Vascular Surgery Department, University of Siena, Siena, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bruni', 'Affiliation': 'Outpatient Department for Hard-to-Heal skin ulcers, San Giuseppe Hospital, Empoli, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Serantoni', 'Affiliation': 'Vascular Ulcers and Diabetic Foot Surgery Unit, Villa Fiorita Clinic, Prato, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Gazzabin', 'Affiliation': 'Vascular Ulcers and Diabetic Foot Surgery Unit, Villa Fiorita Clinic, Prato, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bucalossi', 'Affiliation': 'Surgery Department, Valdisieve Hospital, Florence, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Polignano', 'Affiliation': 'Vascular Medicine Dpt. USL Toscana Centro, Florence, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Mariani', 'Affiliation': ""Angiomedica Clinic, Colle di Val d'Elsa, Siena, Italy.""}, {'ForeName': 'Bastiani', 'Initials': 'B', 'LastName': 'Luca', 'Affiliation': 'Institute of Clinical Physiology, Italian National Research Council e CNR, Pisa, Italy.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Partsch', 'Affiliation': 'Emeritus, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Phlebology,['10.1177/0268355519858439']
2870,32037096,Predicting the Pharmacokinetic Characteristics of Edaravone Intravenous Injection and Sublingual Tablet Through Modeling and Simulation.,"PURPOSE


Edaravone is a free-radical scavenger with relatively favorable properties of brain penetration. It has been approved for the indications of acute ischemic stroke and amyotrophic lateral sclerosis (ALS). This study aimed to establish a pharmacokinetic (PK) model to fit the PK profile of edaravone after a single sublingual (SL) dose of a novel edaravone tablet and single IV infusion of injectable edaravone in healthy Chinese volunteers participating in a bioavailability study. The model is expected to be useful for predicting the concentration-time profiles of edaravone following different dosing regimens in a healthy Chinese population. The purposes were to identify an optimal dose and dosing regimen for the new SL formulation and to support future clinical exploration of this tablet product in its approved indications and other therapeutic fields being developed.
METHODS


The PK profiles after a single SL dose or IV infusion of edaravone 30 mg can be well described by a 3-compartment linear disposition model, on which a first-order absorption model with a lag time and a parameter for bioavailability was incorporated to fit the absorption phase of the SL dose. Performance of these PK models was evaluated for goodness of fit, residual trends, visual predictive checks, as well as precision of model predictions against external data. The validated models were employed for simulating the PK profiles of edaravone after a single SL dose of 60 mg and IV infusion of 60 mg for 60 min.
FINDINGS


The resultant estimates support the possibility and feasibility of demonstrating bioequivalence between an SL administration of edaravone 60 mg and the currently approved dosing regimen for ALS (ie, 60 mg IV over 60 min) once per day. The calculation of sample size suggested that the requirement for subject number was acceptable considering the general capacity of a Phase I study center, and so were the procedures defined in the protocol.
IMPLICATION


The models can be further applied to simulate favorable concentration-time profiles in diseases with different underlying courses of oxidative stress, and hence facilitate the optimization of current dosing regimens.",2020,The model is expected to be useful for predicting the concentration-time profiles of edaravone following different dosing regimens in a healthy Chinese population.,"['healthy Chinese population', 'healthy Chinese volunteers participating in a bioavailability study']",['novel edaravone tablet and single IV infusion of injectable edaravone'],[],"[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}]",[],,0.0227649,The model is expected to be useful for predicting the concentration-time profiles of edaravone following different dosing regimens in a healthy Chinese population.,"[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, PR China; Phase I Unit, Beijing Tiantan Hoapital, Capital Medical University, Beijing, PR China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, PR China. Electronic address: connie_6096@126.com.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, PR China; Phase I Unit, Beijing Tiantan Hoapital, Capital Medical University, Beijing, PR China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, PR China.'}, {'ForeName': 'Jiaqing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, PR China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, PR China.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Changsha VALS Technology Co Ltd, Hunan, PR China.'}, {'ForeName': 'Xingquan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, PR China; Phase I Unit, Beijing Tiantan Hoapital, Capital Medical University, Beijing, PR China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, PR China.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, PR China; Phase I Unit, Beijing Tiantan Hoapital, Capital Medical University, Beijing, PR China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, PR China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, PR China; Phase I Unit, Beijing Tiantan Hoapital, Capital Medical University, Beijing, PR China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, PR China.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.01.006']
2871,31479770,Which Dose Specification Should Be Used for NRG Radiation Therapy Trials: Dose-to-Medium or Dose-to-Water?,"PURPOSE


To compare the doses calculated by the Analytical Anisotropic Algorithm (AAA), Acuros dose-to-medium, and Acuros dose-to-water for the patients with lung cancer treated at our institution and show that further investigation and clarification are needed about what dose specifications should be used for NRG clinical trials.
METHODS AND MATERIALS


Twenty-one patients with lung cancer who previously received intensity modulated radiation therapy or volumetric modulated arc therapy-based treatments at our institution were analyzed by recalculating their plans for each one with the AAA algorithm (reviewed and approved by our radiation oncologists) and with both reporting modes of the Acuros algorithm. All plans used the same monitor units as the original approved plan and a 2.5-mm grid size. For each patient, D 100  of clinical target volume (CTV) and CTV coverage ratios in each plan were compared, and dose distributions and dose-volume histograms calculated by AAA, Acuros dose-to-water (D w,m ), and Acuros dose-to-medium (D m,m ) were compared as well.
RESULTS


Differences between CTV D 100  calculated by AAA and Acuros D m,m  were larger than the differences between AAA and Acuros XB D w,m  for all patients. When D 100  of CTV was evaluated, the largest difference between AAA and Acuros D m,m  was 14.12% and between AAA and Acuros XB D w,m  was 3.68%. The average differences between the CTV D 100  calculated by AAA and Acuros D m,m  was 5.39%. Coverage ratio between Acuros D m,m  and AAA ranges from 51.08% to 100% with an average of 91.32%; coverage ratio between Acuros D w,m  and AAA ranges from 87.2% to 100.41% with average of 98.94%; coverage ratio between Acuros D m,m  and Acuros D w,m  ranges from 58.58% to 100% with an average of 92.03%.
CONCLUSIONS


The present study shows large and systematic differences in doses calculated by AAA and Acuros D m,m . Therefore, further investigation and clarification are needed about which dose reporting mode should be used.",2020,"RESULTS


Differences between CTV D 100  calculated by AAA and Acuros D m,m  were larger than the differences between AAA and Acuros XB D w,m  for all patients.","['Twenty-one patients with lung cancer who previously received intensity modulated radiation therapy or volumetric modulated arc therapy-based treatments at our institution were analyzed by recalculating their plans for each one with the AAA algorithm (reviewed and approved by our radiation oncologists) and with both reporting modes of the Acuros algorithm', 'patients with lung cancer']",[],"['Coverage ratio', 'CTV D 100  calculated by AAA and Acuros D m,m', 'clinical target volume (CTV) and CTV coverage ratios']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C1514693', 'cui_str': 'Radiation oncologist'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]",[],"[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0454198', 'cui_str': 'Clinical target volume'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}]",21.0,0.0152629,"RESULTS


Differences between CTV D 100  calculated by AAA and Acuros D m,m  were larger than the differences between AAA and Acuros XB D w,m  for all patients.","[{'ForeName': 'Maria Lavin', 'Initials': 'ML', 'LastName': 'Cabanas', 'Affiliation': 'Department of Radiation Oncology, University of Pittsburgh Medical Center Cancer Centers, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Chenyu', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Cleveland Clinic at Akron General, Akron, Ohio. Electronic address: yanc2@ccf.org.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Lalonde', 'Affiliation': 'Department of Radiation Oncology, University of Pittsburgh Medical Center Cancer Centers, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Dwight E', 'Initials': 'DE', 'LastName': 'Heron', 'Affiliation': 'Department of Radiation Oncology, University of Pittsburgh Medical Center Cancer Centers, Pittsburgh, Pennsylvania.'}, {'ForeName': 'M Saiful', 'Initials': 'MS', 'LastName': 'Huq', 'Affiliation': 'Department of Radiation Oncology, University of Pittsburgh Medical Center Cancer Centers, Pittsburgh, Pennsylvania.'}]",Practical radiation oncology,['10.1016/j.prro.2019.08.008']
2872,33064780,"Alcohol use, depressive symptoms, and intimate partner violence perpetration: A longitudinal analysis among men with HIV in northern Vietnam.","BACKGROUND


While the link between alcohol use and male-perpetrated intimate partner violence (IPV) has been well-established, research is needed to test whether psychosocial factors interact with alcohol use to exacerbate IPV perpetration. We tested whether depressive symptoms influenced the strength and/or direction of the alcohol-IPV relationship among men with HIV in Vietnam.
METHODS


This study is a secondary analysis using data from a randomized controlled trial conducted in Thai Nguyen, Vietnam. Participants were clinic patients with HIV and hazardous alcohol use. Questionnaires were administered at baseline, three, six, and 12 months. Alcohol use was assessed as proportion of days alcohol abstinent. Analyses were restricted to males who reported being married/cohabitating at baseline (N = 313). Multilevel growth models were used to test whether time-varying depressive symptoms modified the time-varying effect of alcohol use on IPV perpetration.
RESULTS


Time-varying depressive symptoms modified the effect of proportion of days alcohol abstinent on IPV perpetration. However, the pattern of effect modification was not as expected, as reporting depressive symptoms weakened the alcohol-IPV relationship. At times when participants screened negative for depressive symptoms, those who reported higher proportion of days alcohol abstinent than usual had significantly lower odds of IPV perpetration (Odds Ratio [OR] = 0.17, 95% Confidence Interval 0.06, 0.45, p = 0.0004). At times when participants screened positive for depressive symptoms, there was no observed effect of alcohol use on IPV perpetration (OR = 4.28, 95% CI 0.80, 22.78, p = 0.09).
CONCLUSION


The findings highlight the complex nature of the alcohol-IPV relationship and the need to investigate the intersection between hazardous drinking, mental health, and IPV. Men who concurrently report depressive symptoms and heightened alcohol use may be socially isolated from an intimate partner or experiencing fatigue, leading to less alcohol-related IPV perpetration. Mental health interventions addressing depression and alcohol misuse integrated into HIV services may reduce IPV perpetration.",2020,"At times when participants screened positive for depressive symptoms, there was no observed effect of alcohol use on IPV perpetration (OR = 4.28, 95% CI 0.80, 22.78, p = 0.09).
","['males who reported being married/cohabitating at baseline', 'Men who concurrently report depressive symptoms and heightened alcohol use may be socially isolated from an intimate partner or experiencing fatigue, leading to less alcohol-related IPV perpetration', 'Participants were clinic patients with HIV and hazardous alcohol use', 'men with HIV in Vietnam', 'men with HIV in northern Vietnam', 'male-perpetrated intimate partner violence (IPV', 'Thai Nguyen, Vietnam']",[],"['Alcohol use, depressive symptoms, and intimate partner violence perpetration', 'depressive symptoms', 'IPV perpetration', 'alcohol use on IPV perpetration', 'proportion of days alcohol abstinent']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0555047', 'cui_str': 'Married'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0699756', 'cui_str': 'Intimate'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}]",[],"[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}]",313.0,0.0537053,"At times when participants screened positive for depressive symptoms, there was no observed effect of alcohol use on IPV perpetration (OR = 4.28, 95% CI 0.80, 22.78, p = 0.09).
","[{'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Hershow', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'H Luz McNaughton', 'Initials': 'HLM', 'LastName': 'Reyes', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Tran Viet', 'Initials': 'TV', 'LastName': 'Ha', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Chander', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Nguyen Vu Tuyet', 'Initials': 'NVT', 'LastName': 'Mai', 'Affiliation': 'Yen Hoa Health Clinic, University of North Carolina Vietnam, Hanoi, Vietnam.'}, {'ForeName': 'Teerada', 'Initials': 'T', 'LastName': 'Sripaipan', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Frangakis', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Latkin', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Heidi E', 'Initials': 'HE', 'LastName': 'Hutton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Pettifor', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Maman', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Vivian F', 'Initials': 'VF', 'LastName': 'Go', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}]",PloS one,['10.1371/journal.pone.0240674']
2873,33064803,The Protective Effect of Daytime Sleep on Planning and Risk-Related Decision Making in Emerging Adults.,"We assessed the effect of a daytime sleep opportunity on planning and risk-related decision making in emerging adults using multiple neurobehavioral assessments. 136 healthy emerging adults (20.0 ± 1.5 years), 65% female, performed the Risky-Gains Task (RGT) and the Tower of London test (TOL) twice. Between these assessments, they were randomized to either have a sleep opportunity monitored by polysomnography (Sleep group, n=101) or to stay awake (Wake group, n=35). During Test 2, in comparison to the Sleep group, the Wake group showed increased sleepiness, worse planning ability and more decrease in reaction times when selecting risky choices. Changes in TOL steps used and RGT response time was correlated with the number of central and frontal fast sleep spindles, respectively. These results indicate that among emerging adults who commonly have poor sleep patterns, a daytime sleep opportunity was related to better planning ability, better psychomotor vigilance and stable response speeds in risk-related decision-making. Changes in planning and risk-related decision making correlated with the number of sleep spindles during the nap, supporting a specific role for sleep in modulating planning and potentially other higher-order cognitive functions.",2020,"Changes in TOL steps used and RGT response time was correlated with the number of central and frontal fast sleep spindles, respectively.","['136 healthy emerging adults (20.0 ± 1.5 years), 65% female, performed the Risky-Gains Task (RGT) and the Tower of London test (TOL) twice', 'Emerging Adults']","['daytime sleep', 'Daytime Sleep', 'sleep opportunity monitored by polysomnography (Sleep group, n=101) or to stay awake']","['Changes in TOL steps used and RGT response time', 'reaction times', 'increased sleepiness, worse planning ability']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4505410', 'cui_str': 'Tower of London Test'}, {'cui': 'C1720725', 'cui_str': 'Twice'}]","[{'cui': 'C4075948', 'cui_str': 'Sleeps during day'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0234422', 'cui_str': 'Awake'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",136.0,0.0145979,"Changes in TOL steps used and RGT response time was correlated with the number of central and frontal fast sleep spindles, respectively.","[{'ForeName': 'Mark Lawrence', 'Initials': 'ML', 'LastName': 'Wong', 'Affiliation': 'Department of Psychology, University of Exeter, Devon, United Kingdom.'}, {'ForeName': 'Esther Yuet Ying', 'Initials': 'EYY', 'LastName': 'Lau', 'Affiliation': 'Department of Psychology, The Education University of Hong Kong, Hong Kong.'}, {'ForeName': 'Yeuk Ching', 'Initials': 'YC', 'LastName': 'Lam', 'Affiliation': 'Department of Psychology, The Education University of Hong Kong, Hong Kong.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Rusak', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Chia-Huei', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Research Institute of Electrical Communication, Tohoku University, Sendai, Japan.'}, {'ForeName': 'Tatia Mei Chun', 'Initials': 'TMC', 'LastName': 'Lee', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Yun Kwok', 'Initials': 'YK', 'LastName': 'Wing', 'Affiliation': 'Sleep Assessment Unit, Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong.'}]",Social cognitive and affective neuroscience,['10.1093/scan/nsaa140']
2874,33060632,Identifying a nasal gene expression signature associated with hyperinflation and treatment response in severe COPD.,"Hyperinflation contributes to dyspnea intensity in COPD. Little is known about the molecular mechanisms underlying hyperinflation and how inhaled corticosteroids (ICS) affect this important aspect of COPD pathophysiology. To investigate the effect of ICS/long-acting β 2 -agonist (LABA) treatment on both lung function measures of hyperinflation, and the nasal epithelial gene-expression profile in severe COPD. 117 patients were screened and 60 COPD patients entered a 1-month run-in period on low-dose ICS/LABA budesonide/formoterol (BUD/F) 200/6 one inhalation b.i.d. Patients were then randomly assigned to 3-month treatment with either a high dose BDP/F 100/6 two inhalations b.i.d. (n = 31) or BUD/F 200/6 two inhalations b.i.d. (n = 29). Lung function measurements and nasal epithelial gene-expression were assessed before and after 3-month treatment and validated in independent datasets. After 3-month ICS/LABA treatment, residual volume (RV)/total lung capacity (TLC)% predicted was reduced compared to baseline (p < 0.05). We identified a nasal gene-expression signature at screening that associated with higher RV/TLC% predicted values. This signature, decreased by ICS/LABA treatment was enriched for genes associated with increased p53 mediated apoptosis was replicated in bronchial biopsies of COPD patients. Finally, this signature was increased in COPD patients compared to controls in nasal, bronchial and small airways brushings. Short-term ICS/LABA treatment improves RV/TLC% predicted in severe COPD. Furthermore, it decreases the expression of genes involved in the signal transduction by the p53 class mediator, which is a replicable COPD gene expression signature in the upper and lower airways.Trial registration: ClinicalTrials.gov registration number NCT01351792 (registration date May 11, 2011), ClinicalTrials.gov registration number NCT00848406 (registration date February 20, 2009), ClinicalTrials.gov registration number NCT00158847 (registration date September 12, 2005).",2020,"This signature, decreased by ICS/LABA treatment was enriched for genes associated with increased p53 mediated apoptosis was replicated in bronchial biopsies of COPD patients.","['117 patients were screened and 60 COPD patients entered a 1-month run-in period on low-dose ICS', 'severe COPD']","['LABA budesonide/formoterol (BUD/F', 'LABA', 'ICS/long-acting β 2 -agonist (LABA']","['Lung function measurements and nasal epithelial gene-expression', 'p53 mediated apoptosis', 'residual volume (RV)/total lung capacity (TLC)% predicted', 'RV/TLC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}, {'cui': 'C0086571', 'cui_str': 'Lung Capacities'}, {'cui': 'C0008569', 'cui_str': 'Thin Layer Chromatography'}]",117.0,0.157791,"This signature, decreased by ICS/LABA treatment was enriched for genes associated with increased p53 mediated apoptosis was replicated in bronchial biopsies of COPD patients.","[{'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Faiz', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Imkamp', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. k.imkamp@umcg.nl.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'van der Wiel', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Ilse M', 'Initials': 'IM', 'LastName': 'Boudewijn', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Gerard H', 'Initials': 'GH', 'LastName': 'Koppelman', 'Affiliation': 'GRIAC (Groningen Research Institute for Asthma and COPD), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Corry-Anke', 'Initials': 'CA', 'LastName': 'Brandsma', 'Affiliation': 'GRIAC (Groningen Research Institute for Asthma and COPD), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Timens', 'Affiliation': 'GRIAC (Groningen Research Institute for Asthma and COPD), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Vroegop', 'Affiliation': 'Department of Pulmonary Diseases, Martini Hospital Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Henk R', 'Initials': 'HR', 'LastName': 'Pasma', 'Affiliation': 'Department of Pulmonary Diseases, Medical Center Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Wim G', 'Initials': 'WG', 'LastName': 'Boersma', 'Affiliation': 'Department of Pulmonary Diseases, Medical Center Alkmaar, Alkmaar, The Netherlands.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Wielders', 'Affiliation': 'Department of Pulmonary Diseases, Catharina Hospital Eindhoven, Eindhoven, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van den Elshout', 'Affiliation': 'Department of Pulmonary Diseases, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mansour', 'Affiliation': 'Department of Pulmonary Diseases, Orbis Concern, Sittard, The Netherlands.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Steiling', 'Affiliation': 'Division of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Avrum', 'Initials': 'A', 'LastName': 'Spira', 'Affiliation': 'Division of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Lenburg', 'Affiliation': 'Division of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Irene H', 'Initials': 'IH', 'LastName': 'Heijink', 'Affiliation': 'GRIAC (Groningen Research Institute for Asthma and COPD), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Dirkje S', 'Initials': 'DS', 'LastName': 'Postma', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'van den Berge', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}]",Scientific reports,['10.1038/s41598-020-72551-0']
2875,33060783,Duodenal acidification induces gastric relaxation and alters epithelial barrier function by a mast cell independent mechanism.,"Duodenal hyperpermeability and low-grade inflammation in functional dyspepsia is potentially related to duodenal acid exposure. We aimed to evaluate in healthy volunteers the involvement of mast cell activation on the duodenogastric reflex and epithelial integrity during duodenal acidification. This study consisted of 2 parts: (1) Duodenal infusion of acid or saline during thirty minutes in a randomized, double-blind cross-over manner with measurement of intragastric pressure (IGP) using high resolution manometry and collection of duodenal biopsies to measure epithelial barrier function and the expression of cell-to-cell adhesion proteins. Mast cells and eosinophils were counted and activation and degranulation status were assessed. (2) Oral treatment with placebo or mast cell stabilizer disodiumcromoglycate (DSCG) prior to duodenal perfusion with acid, followed by the procedures described above. Compared with saline, acidification resulted in lower IGP (P < 0.01), increased duodenal permeability (P < 0.01) and lower protein expression of claudin-3 (P < 0.001). Protein expression of tryptase (P < 0.001) was increased after acid perfusion. Nevertheless, an ultrastructural examination did not reveal degranulation of mast cells. DSCG did not modify the drop in IGP and barrier dysfunction induced by acid. Duodenal acidification activates an inhibitory duodenogastric motor reflex and, impairs epithelial integrity in healthy volunteers. However, these acid mediated effects occur independently from mast cell activation.",2020,"Compared with saline, acidification resulted in lower IGP (P < 0.01), increased duodenal permeability (P < 0.01) and lower protein expression of claudin-3 (P < 0.001).","['healthy volunteers', '2 parts']","['DSCG', 'acid or saline', 'double-blind cross-over manner with measurement of intragastric pressure (IGP', 'placebo or mast cell stabilizer disodiumcromoglycate (DSCG']","['IGP and barrier dysfunction', 'duodenal permeability', 'Mast cells and eosinophils were counted and activation and degranulation status', 'lower IGP', 'lower protein expression of claudin-3', 'Protein expression of tryptase', 'Duodenal hyperpermeability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0449719', 'cui_str': 'Part'}]","[{'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1268905', 'cui_str': 'Mast cell stabilizer'}]","[{'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0024880', 'cui_str': 'Mast cell'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0147080', 'cui_str': 'Tryptase'}]",,0.0943546,"Compared with saline, acidification resulted in lower IGP (P < 0.01), increased duodenal permeability (P < 0.01) and lower protein expression of claudin-3 (P < 0.001).","[{'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Vanheel', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vicario', 'Affiliation': ""Digestive Diseases Research Unit, Department of Gastroenterology, Institut de Recerca Vall d'Hebron, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Dorien', 'Initials': 'D', 'LastName': 'Beeckmans', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Cocca', 'Affiliation': 'Department of Digestive Diseases, Campus Bio-Medico University, Endoscopy Unit-Azienda Ospedaliero Universitaria di Modena, Rome, Italy.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Wauters', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Accarie', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium.'}, {'ForeName': 'Joran', 'Initials': 'J', 'LastName': 'Toth', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium.'}, {'ForeName': 'Hans-Reimer', 'Initials': 'HR', 'LastName': 'Rodewald', 'Affiliation': 'Division of Cellular Immunology, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'De Hertogh', 'Affiliation': 'Department of Pathology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Matteoli', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Boeckxstaens', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Tack', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium.'}, {'ForeName': 'Ricard', 'Initials': 'R', 'LastName': 'Farre', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium. ricard.farre@kuleuven.be.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Vanuytsel', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium.'}]",Scientific reports,['10.1038/s41598-020-74491-1']
2876,33060889,Interim versus final results of the trial-not the flip side of the same coin!,,2018,,[],[],[],[],[],[],,0.0166811,,"[{'ForeName': 'Om Prakash', 'Initials': 'OP', 'LastName': 'Yadava', 'Affiliation': 'National Heart Institute, 49-50, Community Centre, New Delhi, 110065 India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-018-0682-7']
2877,33060948,Off-pump versus on-pump coronary artery bypass grafting-a surreal controversy?,"As per the findings of the SYNTAX Trial, it has been established that coronary artery bypass grafting (CABG) affords the best long-term results in patients with multivessel disease. However, it is still a point of contention whether 'off-pump' CABG (OPCAB) (on cardiopulmonary bypass) is better. Many studies appear to establish the superiority of one or the other. But there is still no well-planned multi-centre randomised controlled trial looking into all aspects of the issue that can, once and for all, put the controversy to rest. But as long as one is able to give the patient a good result, does it really matter whether the procedure is done off or on pump? This article looks at the available evidence with regard to various parameters comparing OPCAB and conventional CABG in an attempt to answer the question, if at all, it is a question!",2018,"As per the findings of the SYNTAX Trial, it has been established that coronary artery bypass grafting (CABG) affords the best long-term results in patients with multivessel disease.",['patients with multivessel disease'],['coronary artery bypass grafting (CABG'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]",[],,0.0346279,"As per the findings of the SYNTAX Trial, it has been established that coronary artery bypass grafting (CABG) affords the best long-term results in patients with multivessel disease.","[{'ForeName': 'Anirban', 'Initials': 'A', 'LastName': 'Kundu', 'Affiliation': 'National Heart Institute, 49 Community Centre, New Delhi, Delhi 110065 India.'}, {'ForeName': 'Om Prakash', 'Initials': 'OP', 'LastName': 'Yadava', 'Affiliation': 'National Heart Institute, 49 Community Centre, New Delhi, Delhi 110065 India.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Taggart', 'Affiliation': 'University of Oxford, Oxford, UK.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-018-0668-5']
2878,33060954,Hybrid myocardial revascularization.,"Background


In patients with advanced coronary artery disease (CAD), coronary artery bypass grafting (CABG) is associated with improved long-term outcomes while percutaneous coronary intervention (PCI) is associated with lower periprocedural complications. A new approach has emerged in the last decade that attempts to reap the benefits of bypass surgery and stenting while minimizing the shortcomings of each approach, hybrid myocardial revascularization (HMR).Three strategies for timing of the hybrid revascularization exists, each with their own inherent advantages and shortcomings: (1) CABG followed by PCI, (2) PCI followed by CABG, or (3) simultaneous CABG + PCI in a hybrid suite.
Studies


The results of the first randomized control trial comparing HMR (CABG first) and standard CABG, POL-MIDES (Prospective Randomized PilOt Study EvaLuating the Safety and Efficacy of Hybrid Revascularization in MultIvessel Coronary Artery DisEaSe), show HMR was feasible for 93.9% of patients whereas conversion to standard CABG was required for 6.1%. At 1 year, both groups had similar all-cause mortality (CABG 2.9% vs. HMR 2%) and major adverse clinical event (MACE)-free survival rates (CABG 92.2% vs. HMR 89.8%). Results of observational and comparative studies show that minimally invasive HMR procedures in patients with multivessel CAD carry minimal perioperative mortality risk and low morbidity and do not increase the risk of postoperative bleeding. The advantage they offer in comparison to classical surgical revascularization is indeed faster rehabilitation and patient's return to normal life.
Conclusion


Hybrid myocardial revascularization has been developed as a promising technique for the treatment of high-risk patients with CAD. Hybrid revascularization using minimally invasive surgical techniques combined with PCI offers to a part of patients an advantage of optimal revascularization of the most important artery of the heart, together with adequate myocardial revascularization in a relatively delicate way. Indeed, to patients with high operative risk of standard surgery, it offers an alternative which should be considered carefully.",2018,"At 1 year, both groups had similar all-cause mortality (CABG 2.9% vs. HMR 2%) and major adverse clinical event (MACE)-free survival rates (CABG 92.2% vs. HMR 89.8%).","['patients with high operative risk of standard surgery', 'MultIvessel Coronary Artery DisEaSe', 'patients with advanced coronary artery disease (CAD), coronary artery bypass grafting (CABG', 'high-risk patients with CAD', 'patients with multivessel CAD']","['percutaneous coronary intervention (PCI', 'HMR (CABG first) and standard CABG, POL-MIDES', 'Hybrid Revascularization', 'Hybrid revascularization using minimally invasive surgical techniques combined with PCI']","['cause mortality', 'risk of postoperative bleeding', 'perioperative mortality risk and low morbidity', 'major adverse clinical event (MACE)-free survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0027056', 'cui_str': 'Myocardial revascularization'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0353878,"At 1 year, both groups had similar all-cause mortality (CABG 2.9% vs. HMR 2%) and major adverse clinical event (MACE)-free survival rates (CABG 92.2% vs. HMR 89.8%).","[{'ForeName': 'Yugal Kishore', 'Initials': 'YK', 'LastName': 'Mishra', 'Affiliation': 'Department of Cardiac Surgery, Fortis Escorts Heart Institute, Okhla Road, New Delhi, 110025 India.'}, {'ForeName': 'Jatin', 'Initials': 'J', 'LastName': 'Yadav', 'Affiliation': 'Department of Cardiac Surgery, Fortis Escorts Heart Institute, Okhla Road, New Delhi, 110025 India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-018-0646-y']
2879,33061107,Graft patency at 3 months after off- and on-pump coronary bypass surgery: a randomized trial.,"Purpose


Coronary artery bypass grafting (CABG) is performed either with the aid of cardiopulmonary bypass (on-pump) or without cardiopulmonary bypass (off-pump). There is a scarcity of angiographic data to support the non-inferiority of off-pump technique to on-pump technique. The objective of this study is to ascertain the non-inferiority of off-pump CABG when compared to on-pump CABG in terms of angiographically assessed graft patency at 3 months.
Methods


A total of 320 patients with multivessel coronary artery disease were enrolled in a multicenter prospective randomized trial either to on-pump CABG ( n  = 162) or off-pump CABG ( n  = 158) between March 2016 through March 2017. Graft patency was evaluated by using either multidetector computerized tomographic angiography or conventional coronary angiography at 3 months. The major adverse cardiac and cardiovascular events (MACCE) were also analyzed at 3 months.
Results


The median number of grafts per patient in off-pump was 3.00 (Q1:3.00 and Q3:4.00) vs on-pump 4.00 (Q1:3.00 to Q3:4.00), and the mean number of grafts per patient was lower in the off-pump CABG at 3.45 ± 0.75 vs 3.64 ± 0.70 in the on-pump CABG ( p  = 0.01). There was no significant difference in mortality at 3 months between the off-pump (0.63%) and on-pump groups (1.85%) with  p  value of 0.62. The cumulative combined MACCE showed significant difference between off-pump group (0.63%) and on-pump group (5.55%),  p  = 0.01. Follow-up angiograms were done in 239 (75%) patients with 120 off-pump and 119 in the on-pump group. The analysis was also done regarding graft patency in a graded manner-when analysis of A (excellent) grafts vs B (stenosed) grafts and O (occluded) grafts were made, there was no statistically significant difference in overall graft patency at 3 months between on-pump [376 /429 grafts (87.6%)] and off-pump [366 /420 grafts (87.1%)] groups ( p  = 0.82). The patency rates were similar among bypass conduits (left internal thoracic artery (ITA) in off-pump (91.4%) vs on-pump (92.9%)  p  = 0.66, right ITA in off-pump (82.1%) vs on-pump (81.8%)  p  = 0.97, radial artery in off-pump (84.4%) vs on-pump (82.6%)  p  = 0.81; saphenous vein in off-pump (85.8%) vs on-pump (86.3%),  p  = 0.86 and among 3 coronary territories.
Conclusions


Off-pump CABG is non-inferior to on-pump CABG in terms of overall graft patency at 3 months and was associated with a fewer combined cumulative MACCE compared to on-pump CABG.",2020,"Conclusions


Off-pump CABG is non-inferior to on-pump CABG in terms of overall graft patency at 3 months and was associated with a fewer combined cumulative MACCE compared to on-pump CABG.",['320 patients with multivessel coronary artery disease'],"['Coronary artery bypass grafting (CABG', 'pump CABG ( n \u2009=\u2009162) or off-pump CABG', 'pump CABG', 'pump coronary bypass surgery', 'multidetector computerized tomographic angiography or conventional coronary angiography']","['major adverse cardiac and cardiovascular events (MACCE', 'median number of grafts per patient in off-pump', 'mean number of grafts per patient', 'Graft patency', 'graft patency', 'overall graft patency', 'patency rates', 'mortality']","[{'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",320.0,0.121618,"Conclusions


Off-pump CABG is non-inferior to on-pump CABG in terms of overall graft patency at 3 months and was associated with a fewer combined cumulative MACCE compared to on-pump CABG.","[{'ForeName': 'Lokeswara Rao', 'Initials': 'LR', 'LastName': 'Sajja', 'Affiliation': 'Division of Cardiothoracic Surgery, STAR Hospitals, Road no. 10, Banjara Hills, Hyderabad, Telangana 500 034 India.'}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Sarkar', 'Affiliation': 'Division of Cardiothoracic Surgery, Medica Superspeciality Hospital, 127-Mukundapur, EM bypass, Kolkata, 700025 India.'}, {'ForeName': 'Gopichand', 'Initials': 'G', 'LastName': 'Mannam', 'Affiliation': 'Division of Cardiothoracic Surgery, STAR Hospitals, Road no. 10, Banjara Hills, Hyderabad, Telangana 500 034 India.'}, {'ForeName': 'Venkata Krishna Kumar', 'Initials': 'VKK', 'LastName': 'Kodali', 'Affiliation': 'Division of Cardiothoracic Surgery, Krishna Institute of Medical Sciences, 1-8-31/1,Minister Road, Secunderabad, Telangana 500003 India.'}, {'ForeName': 'Chandrasekar', 'Initials': 'C', 'LastName': 'Padmanabhan', 'Affiliation': 'Division of Cardiothoracic Surgery, G Kuppuswamy Naidu Memorial Hospital, Pappanaicken Palayam, Coimbatore, 641 037 India.'}, {'ForeName': 'Sanjeeth', 'Initials': 'S', 'LastName': 'Peter', 'Affiliation': 'Division of Cardiothoracic Surgery, DDMM Heart Institute, Mission Road, Nadiad, Gujarat 387002 India.'}, {'ForeName': 'Anvay', 'Initials': 'A', 'LastName': 'Mulay', 'Affiliation': 'Division of Cardiothoracic Surgery, Fortis Hospital, Multi-Specialty Hospital Mulund West, Mumbai, 400078 India.'}, {'ForeName': 'Prashanthi', 'Initials': 'P', 'LastName': 'Beri', 'Affiliation': 'Division of Clinical Research, Sajja Heart Foundation, Srinagar Colony, Hyderabad, 500073 India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-019-00869-0']
2880,33061158,One-year outcomes of off- and on-pump coronary artery bypass grafting: PROMOTE patency trial.,"Purpose


Earlier we reported 3-month graft patency and clinical outcomes of prospective randomized comparison of off-pump and on-pump multivessel coronary artery bypass surgery to evaluate outcomes and graft patency (PROMOTE patency) trial. We now report major adverse cardiac and cerebrovascular events (MACCE) at 1 year of patients who underwent coronary artery bypass grafting (CABG) using either off-pump technique or on-pump technique.
Methods


The PROMOTE patency trial is a two-arm, prospective, randomized, multicentre trial, and enrolled 320 patients with multivessel coronary artery disease from March 2016 through March 2017 at 6 centres and were randomly assigned to undergo either off-pump CABG (OPCAB) ( n  = 158 patients) or on-pump CABG ( n  = 162 patients). The outcomes at 1 year were assessed.
Results


One mortality (0.64%) occurred in off-pump group (at 30 days) and 4 (2.48%) in on-pump group (1 at 30 days, 2 at 3 months, and 1 at 1 year) ( p  = 0.37). There was no difference between off-pump and on-pump groups in the outcomes of nonfatal myocardial infarction (1 in off-pump and 2 in on-pump group,  p  = 1.00) and cerebrovascular accident (none in off-pump and 2 in on-pump group,  p  = 0.49). Repeat revascularization was done in one patient in each group ( p  = 1.00).
Conclusion


There was no significant difference in the incidence of MACCE between off-pump and on-pump CABG group at 1 year.",2020,"There was no difference between off-pump and on-pump groups in the outcomes of nonfatal myocardial infarction (1 in off-pump and 2 in on-pump group,  p  = 1.00) and cerebrovascular accident (none in off-pump and 2 in on-pump group,  p  = 0.49).","['patients who underwent coronary artery bypass grafting (CABG) using either off-pump technique or on-pump technique', '320 patients with multivessel coronary artery disease from March 2016 through March 2017 at 6 centres']","['pump CABG (OPCAB) ( n \u2009=\u2009158 patients) or on-pump CABG', 'pump and on-pump multivessel coronary artery bypass surgery', 'pump coronary artery bypass grafting']","['incidence of MACCE', 'Repeat revascularization', 'nonfatal myocardial infarction', 'One mortality', 'cerebrovascular accident']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",320.0,0.117747,"There was no difference between off-pump and on-pump groups in the outcomes of nonfatal myocardial infarction (1 in off-pump and 2 in on-pump group,  p  = 1.00) and cerebrovascular accident (none in off-pump and 2 in on-pump group,  p  = 0.49).","[{'ForeName': 'Lokeswara Rao', 'Initials': 'LR', 'LastName': 'Sajja', 'Affiliation': 'Division of Cardiothoracic Surgery, Star Hospitals, Road no. 10, Banjara Hills, Hyderabad, AP 500 034 India.'}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Sarkar', 'Affiliation': 'Division of Cardiothoracic Surgery, Medica Superspeciality Hospital, 127-Mukundapur, EM Bypass, Kolkata, 700025 India.'}, {'ForeName': 'Gopichand', 'Initials': 'G', 'LastName': 'Mannam', 'Affiliation': 'Division of Cardiothoracic Surgery, Star Hospitals, Road no. 10, Banjara Hills, Hyderabad, AP 500 034 India.'}, {'ForeName': 'Venkata Krishna Kumar', 'Initials': 'VKK', 'LastName': 'Kodali', 'Affiliation': 'Division of Cardiothoracic Surgery, Krishna Institute of Medical Sciences, 1-8-31/1, Minister Road, Secunderabad, Telangana 500003 India.'}, {'ForeName': 'Chandrasekar', 'Initials': 'C', 'LastName': 'Padmanabhan', 'Affiliation': 'Division of Cardiothoracic Surgery, G Kuppuswamy Naidu Memorial Hospital, Pappanaickenpalayam, Coimbatore, 641 037 India.'}, {'ForeName': 'Sanjeeth', 'Initials': 'S', 'LastName': 'Peter', 'Affiliation': 'Division of Cardiothoracic Surgery, DDMM Heart Institute, Mission Road, Nadiad, Gujarat 387 002 India.'}, {'ForeName': 'Anvay', 'Initials': 'A', 'LastName': 'Mulay', 'Affiliation': 'Division of Cardiothoracic Surgery, Fortis Hospital, Multi-Specialty Hospital Mulund West, Mumbai, 400 078 India.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Sardar', 'Affiliation': 'Division of Cardiothoracic Surgery, Medica Superspeciality Hospital, 127-Mukundapur, EM Bypass, Kolkata, 700025 India.'}, {'ForeName': 'Prashanthi', 'Initials': 'P', 'LastName': 'Beri', 'Affiliation': 'Division of Clinical Research, Sajja Heart Foundation, Srinagar Colony, Hyderabad, 500 073 India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-020-00940-1']
2881,33061172,NOBLE trial-is it time to revise the guidelines?,"The Nordic-Baltic-British left main revascularization trial (NOBLE) is a prospective, randomized, multicentre, non-inferiority trial comparing percutaneous coronary angioplasty (PCI) with coronary artery bypass grafting (CABG) for revascularization of patients with unprotected left main coronary artery (LMCA) stenosis. The primary outcome was a combined endpoint of all-cause mortality, stroke, non-procedural myocardial infarction and repeat revascularization. CABG was found to be superior to PCI with respect to the 5-year MACCE rates (28% vs. 19%) with a hazard ratio (HR) of 1.58 (95% CI 1.24-2.01). All-cause mortality rates were similar, but PCI was associated with increased occurrence of non-procedural myocardial infarction ( p  = 0.0002) and repeat revascularization ( p  = 0.0009). There was no difference in the stroke rates ( p  = 0.11) at 5 years. Currently, European Society of Cardiology and the European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines on myocardial revascularization assign a class 1A recommendation to PCI in patients with unprotected LMCA stenosis with a SYNTAX score < 23. The findings of the NOBLE trial challenge this premise.",2020,There was no difference in the stroke rates ( p  = 0.11) at 5 years.,"['patients with unprotected left main coronary artery (LMCA) stenosis', 'patients with unprotected LMCA stenosis with a SYNTAX score <\u200923']","['CABG', 'percutaneous coronary angioplasty (PCI', 'coronary artery bypass grafting (CABG']","['5-year MACCE rates', 'mortality rates', 'stroke rates', 'occurrence of non-procedural myocardial infarction', 'repeat revascularization', 'combined endpoint of all-cause mortality, stroke, non-procedural myocardial infarction and repeat revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0242231', 'cui_str': 'Coronary artery stenosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0002997', 'cui_str': 'Angioplasty, Coronary Balloon'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]",,0.0681095,There was no difference in the stroke rates ( p  = 0.11) at 5 years.,"[{'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Narayan', 'Affiliation': 'Department of Cardiac Surgery, NH Rabindranath Tagore International Institute of Cardiac Sciences (RTIICS), Kolkata, 700099 India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-020-00965-6']
2882,33061253,Three-Year Results of the SONATA Pivotal Trial of Transcervical Fibroid Ablation for Symptomatic Uterine Myomata.,"Objective:  This article reports on 3-year clinical outcomes of the Sonography Guided Transcervical Ablation of Uterine Fibroids (SONATA) pivotal trial of transcervical fibroid ablation (TFA) in women with symptomatic uterine myomata.  Materials and Methods:  The SONATA, prospective, controlled, multicenter interventional trial enrolled 147 premenopausal women with symptomatic uterine fibroids who underwent uterus-preserving, sonography-guided TFA with the Sonata ®  System (Gynesonics, Inc., Redwood City, CA, USA). Clinical outcomes were assessed over 3 years and included surgical reinterventions, Symptom Severity Score (SSS), and Health-Related Quality of Life (HRQoL) subscales of the Uterine Fibroid Symptom and Quality-of-Life Questionnaire, EuroQol 5-Dimension (EQ-5D) questionnaire, Overall Treatment Effect, treatment satisfaction, physical activity, work impairment, pregnancy outcomes, and adverse events.  Results:  The 3-year rates of surgical reintervention for heavy menstrual bleeding calculated by the binomial and Kaplan-Meier methods were 9.2% and 8.2%, respectively. Compared to baseline, mean SSS decreased from 55 ± 19 to 22 ± 21, HRQoL increased from 40 ± 21 to 83 ± 23, and EQ-5D increased from 0.72 ± 0.21 to 0.88 ± 0.16 (all  p  < 0.001). Treatment benefit on the SSS, HRQoL, and EQ-5Q exceeded the minimal clinically important difference at every follow-up visit over 3 years. At 3 years, 94% of the subjects reported treatment satisfaction, 88% reported reduced fibroid symptoms, work absenteeism due to fibroid symptoms decreased from 2.9% to 1.4%, and impairment due to fibroids decreased from 51% to 12% for work, and 58% to 14% for physical activity (all  p  < 0.001). No late complications occurred.  Conclusions:  Women treated with sonography-guided TFA in the SONATA pivotal trial experienced significant and durable reduction of fibroid-related symptoms, with low surgical reintervention rates over 3 years of follow-up.",2020,"Treatment benefit on the SSS, HRQoL, and EQ-5Q exceeded the minimal clinically important difference at every follow-up visit over 3 years.","['147 premenopausal women with symptomatic uterine fibroids who underwent uterus-preserving, sonography-guided TFA with the Sonata ®  System (Gynesonics, Inc., Redwood City, CA, USA', 'women with symptomatic uterine myomata']","['Transcervical Fibroid Ablation', 'sonography-guided TFA', 'Sonography Guided Transcervical Ablation of Uterine Fibroids', 'transcervical fibroid ablation (TFA']","['impairment due to fibroids', 'late complications', 'surgical reinterventions, Symptom Severity Score (SSS), and Health-Related Quality of Life (HRQoL) subscales of the Uterine Fibroid Symptom and Quality-of-Life Questionnaire, EuroQol 5-Dimension (EQ-5D) questionnaire, Overall Treatment Effect, treatment satisfaction, physical activity, work impairment, pregnancy outcomes, and adverse events', 'reduced fibroid symptoms, work absenteeism due to fibroid symptoms', '3-year rates of surgical reintervention for heavy menstrual bleeding calculated by the binomial and Kaplan-Meier methods', 'mean SSS', 'physical activity', 'EQ-5D', 'SSS, HRQoL, and EQ-5Q', 'treatment satisfaction']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0040982', 'cui_str': 'Trifluoroacetic Acid'}, {'cui': 'C0876170', 'cui_str': 'Sonata'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1002377', 'cui_str': 'Redwood'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0442344', 'cui_str': 'Transcervical approach - uterine'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0040982', 'cui_str': 'Trifluoroacetic Acid'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}]","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",147.0,0.113088,"Treatment benefit on the SSS, HRQoL, and EQ-5Q exceeded the minimal clinically important difference at every follow-up visit over 3 years.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lukes', 'Affiliation': ""Carolina Women's Research and Wellness Center, Durham, North Carolina, USA.""}, {'ForeName': 'Minda A', 'Initials': 'MA', 'LastName': 'Green', 'Affiliation': 'Virtua OB/Gyn, Voorhees, New Jersey, USA.'}]",Journal of gynecologic surgery,['10.1089/gyn.2020.0021']
2883,33061281,"Safety and Efficacy of a Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid for Dry Eye Disease: A Randomized, Controlled, Multicenter 3-Month Study.","Purpose


To compare the efficacy and safety of an artificial tear combining the polymers carboxymethylcellulose (CMC) and hyaluronic acid (HA), to a formulation of CMC alone in subjects with dry eye.
Methods


A preservative-free artificial tear (CMC-HA) was compared with an existing artificial tear (CMC). Subjects with mild-to-severe signs and symptoms of dry eye were enrolled in this double-masked, randomized, multicenter trial, and dosed at least twice daily for 90 days, with follow-up visits at Days 7, 30, 60, and 90. Ocular Surface Disease Index (OSDI) was the primary outcome measure. Secondary outcome measures were tear break-up time (TBUT), ocular surface staining, Schirmer test with anesthesia, and visual analog scale (VAS) scores of dry eye symptom severity and formulation acceptability. Safety measures included adverse events, biomicroscopy, and visual acuity.
Results


A total of 460 subjects were enrolled across 45 sites (38 in Europe; 7 in Australia), of whom 454 were randomized to receive treatment. The per-protocol (PP) population consisted of 394 subjects, 364 (92.4%) of whom completed the study. In the PP population, the mean ± SD change from baseline in OSDI score at the primary timepoint, Day 90, was -16.9±17.5 for CMC-HA and -16.0±16.1 for CMC. CMC-HA was non-inferior to CMC based upon a confidence interval method. Both treatments significantly improved ( P <0.001) OSDI, symptom VAS scores, TBUT, and ocular surface staining from baseline at all follow-up visits, with minimal differences between groups. Greater reduction of overall ocular pain/discomfort was reported in subjects using CMC-HA versus CMC ( P =0.048). Approximately 10% of subjects in each group reported treatment-related adverse events of generally mild to moderate severity.
Conclusion


The new CMC-HA formulation was effective and well tolerated, and demonstrates a greater potential for symptom relief compared with CMC. These data support implementation of this formula for the management of dry eye patients.",2020,"The new CMC-HA formulation was effective and well tolerated, and demonstrates a greater potential for symptom relief compared with CMC.","['Dry Eye Disease', 'Subjects with mild-to-severe signs and symptoms of dry eye', 'dry eye patients', 'subjects with dry eye', '394 subjects, 364 (92.4%) of whom completed the study', '460 subjects were enrolled across 45 sites (38 in Europe; 7 in Australia']","['Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid', 'CMC alone', 'existing artificial tear (CMC', 'artificial tear combining the polymers carboxymethylcellulose (CMC) and hyaluronic acid (HA', 'Methods\n\n\nA preservative-free artificial tear (CMC-HA']","['OSDI score', 'Ocular Surface Disease Index (OSDI', 'tear break-up time (TBUT), ocular surface staining, Schirmer test with anesthesia, and visual analog scale (VAS) scores of dry eye symptom severity and formulation acceptability', 'adverse events, biomicroscopy, and visual acuity', 'OSDI, symptom VAS scores, TBUT, and ocular surface staining', 'Safety and Efficacy', 'efficacy and safety', 'overall ocular pain/discomfort']","[{'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0033086', 'cui_str': 'Drug preservative'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0007068', 'cui_str': 'Carboxymethylcellulose'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0151827', 'cui_str': 'Pain in eye'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",460.0,0.0759466,"The new CMC-HA formulation was effective and well tolerated, and demonstrates a greater potential for symptom relief compared with CMC.","[{'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Aragona', 'Affiliation': 'Department of Biomedical Sciences, Università di Messina, Messina, Italy.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Benítez-Del-Castillo', 'Affiliation': 'Department of Ophthalmology, Hospital Clinico de Madrid, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Minas T', 'Initials': 'MT', 'LastName': 'Coroneo', 'Affiliation': 'M.T. Coroneo Pty. Ltd, Randwick, NSW, Australia.'}, {'ForeName': 'Subhanjan', 'Initials': 'S', 'LastName': 'Mukherji', 'Affiliation': 'Department of Ophthalmology, James Paget University Hospital, Great Yarmouth, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Vandewalle', 'Affiliation': 'Department of Ophthalmology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Algis', 'Initials': 'A', 'LastName': 'Vingrys', 'Affiliation': 'University of Melbourne EyeCare Clinic, Carlton, VIC, Australia.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Allergan, an AbbVie company, Irvine, CA, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Carlisle-Wilcox', 'Affiliation': 'Allergan, an AbbVie company, Irvine, CA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Vehige', 'Affiliation': 'Allergan, an AbbVie company, Irvine, CA, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Simmons', 'Affiliation': 'Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S256480']
2884,33061332,Postoperative Physical Therapy to Prevent Hospital-acquired Pneumonia in Patients Over 80 Years Undergoing Hip Fracture Surgery-A Quasi-experimental Study.,"Background


Hip fracture requiring surgical fixation is a common condition with high mortality and morbidity in the geriatric population. The patients are usually frail, and vulnerable to postoperative complications and delayed recovery. Few studies have investigated physical therapy methods to prevent hospital-acquired pneumonia (HAP) after hip fracture surgery.
Objective


To explore whether an intensified physical therapy regimen can prevent HAP and reduce hospital length of stay in patients aged 80 and older, following hip fracture surgery.
Patients and Methods


The inclusion criterion was patients aged 80 or older who had undergone hip fracture surgery at Örebro University Hospital, Sweden during eight months in 2015-2016 (the ""physical therapy group"") (n=69). The study has a quasi-experimental design with a historical control group (n=64) who had received routine physical therapy treatment. The physical therapy group received intensified postoperative physical therapy treatment, which included daily supervised early mobilization and coached deep breathing exercises with positive expiratory pressure (PEP). The patients were instructed to take deep breaths, and then exhale through the PEP-valve in three sessions of 10 deep breaths, at least four times daily. Early mobilization to a sitting position and walking was advised as soon as possible after surgery.
Results


There was a significantly lower incidence of HAP in the physical therapy group; 2/69 (3%, 95%CI: 1- 10) compared to the historical control group 13/64 (20%, 95%CI: 12-32%) ( p =0.002). Patients in the physical therapy group had a significantly shorter length of stay than the control group (10.6±4 vs 13.4±9 days,  p =0.022).
Conclusion


Intensified physical therapy treatment after hip fracture surgery may be of benefit to reduce the incidence of HAP in patients over 80 years; however, the results need to be confirmed in randomized controlled trials.",2020,"Patients in the physical therapy group had a significantly shorter length of stay than the control group (10.6±4 vs 13.4±9 days,  p =0.022).
","['Hospital-acquired Pneumonia in Patients Over 80 Years', 'patients aged 80 or older who had undergone hip fracture surgery at Örebro University Hospital, Sweden during eight months in 2015-2016 (the ""physical therapy group"") (n=69', 'group (n=64) who had received', 'patients aged 80 and older, following hip fracture surgery']","['routine physical therapy treatment', '95%CI', 'physical therapy group received intensified postoperative physical therapy treatment, which included daily supervised early mobilization and coached deep breathing exercises with positive expiratory pressure (PEP', 'historical control', 'Postoperative Physical Therapy', 'intensified physical therapy regimen']","['HAP', 'shorter length of stay']","[{'cui': 'C0949083', 'cui_str': 'Hospital acquired pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0454496', 'cui_str': 'Deep breathing exercises'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0949083', 'cui_str': 'Hospital acquired pneumonia'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0212089,"Patients in the physical therapy group had a significantly shorter length of stay than the control group (10.6±4 vs 13.4±9 days,  p =0.022).
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ståhl', 'Affiliation': 'Department of Physiotherapy, Örebro University Hospital, Örebro, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Westerdahl', 'Affiliation': 'University Health Care Research Center, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}]",Clinical interventions in aging,['10.2147/CIA.S257127']
2885,33061494,Mediterranean Diet and Naltrexone/Bupropion Treatment for Weight Loss in Overweight and Obese Breast Cancer Survivors and Non-Cancer Participants: A Pilot Randomized Controlled Trial.,"Introduction


The objective of this pilot randomized controlled trial was to investigate the combined effect of a Mediterranean diet and naltrexone/bupropion treatment on body weight, metabolic parameters, and quality of life in overweight or obese breast cancer survivors.
Methods


Forty-four breast cancer survivors were randomly assigned to receive the Mediterranean diet plus naltrexone/bupropion medication (breast cancer survivor MeDiet+NB group) or the Mediterranean diet alone (breast cancer survivor MeDiet-only group). Twenty-eight age-matched non-cancer patients were instructed to consume the Mediterranean diet plus naltrexone/bupropion medication (non-cancer MeDiet+NB group). After the 8-week intervention, changes in body weight, metabolic parameters, nutrient intake, and quality of life of the three groups were assessed.
Results


Significant weight loss of 2.8 kg was noted for the breast cancer survivor MeDiet+NB group, 1.8 kg for the breast cancer survivor MeDiet-only group, and 2.5 kg for the non-cancer MeDiet+NB group after 8 weeks ( P  < 0.05 versus baseline by Wilcoxon's signed-rank test). All three groups also exhibited significantly lower fasting glucose, insulin, and homeostasis model assessment of insulin resistance levels ( P  < 0.05). Quality of life as assessed by self-reported questionnaires showed improvement in all participants ( P  < 0.05). However, there were no significant differences of changes in body weights, metabolic parameters, and quality of life among the three groups or between the MeDiet+NB and MeDiet-only groups.
Conclusion


We found that the Mediterranean diet, with or without naltrexone/bupropion treatment, facilitates weight loss, improves metabolic parameters, and increases quality of life. The combination of the Mediterranean diet with naltrexone/bupropion treatment did not produce superior changes when compared to the Mediterranean diet alone.
Trial Registration


This trial was retrospectively registered on 10 July 2018 as NCT03581630 at ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03581630).",2020,Quality of life as assessed by self-reported questionnaires showed improvement in all participants ( P  < 0.05).,"['overweight or obese breast cancer survivors', 'Overweight and Obese Breast Cancer Survivors and Non-Cancer Participants', 'Twenty-eight age-matched non-cancer patients', 'Methods\n\n\nForty-four breast cancer survivors']","['Mediterranean Diet and Naltrexone/Bupropion', 'Mediterranean diet plus naltrexone/bupropion medication', 'Mediterranean diet plus naltrexone/bupropion medication (breast cancer survivor MeDiet+NB group) or the Mediterranean diet alone (breast cancer survivor MeDiet-only group', 'Mediterranean diet and naltrexone/bupropion', 'naltrexone/bupropion']","['weight loss', 'body weight, metabolic parameters, and quality of life', 'fasting glucose, insulin, and homeostasis model assessment of insulin resistance levels', 'body weight, metabolic parameters, nutrient intake, and quality of life', 'weight loss, improves metabolic parameters', 'Weight Loss', 'Quality of life', 'body weights, metabolic parameters, and quality of life', 'quality of life']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",44.0,0.0212643,Quality of life as assessed by self-reported questionnaires showed improvement in all participants ( P  < 0.05).,"[{'ForeName': 'A-Ra', 'Initials': 'AR', 'LastName': 'Cho', 'Affiliation': 'Department of Family Medicine, Yong-in Severance Hospital, Yonsei University College of Medicine, Yong‑in 16995, Republic of Korea.'}, {'ForeName': 'Won-Jun', 'Initials': 'WJ', 'LastName': 'Choi', 'Affiliation': 'Department of Medicine, Graduate School, Yonsei University, Seoul 03722, Republic of Korea.'}, {'ForeName': 'Yu-Jin', 'Initials': 'YJ', 'LastName': 'Kwon', 'Affiliation': 'Department of Family Medicine, Yong-in Severance Hospital, Yonsei University College of Medicine, Yong‑in 16995, Republic of Korea.'}, {'ForeName': 'Hye Sun', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Collaboration Unit, Department of Research Affairs, Yonsei University College of Medicine, Seoul 06273, Republic of Korea.'}, {'ForeName': 'Sung Gwe', 'Initials': 'SG', 'LastName': 'Ahn', 'Affiliation': 'Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Republic of Korea.'}, {'ForeName': 'Ji-Won', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Department of Family Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Republic of Korea.'}]","Diabetes, metabolic syndrome and obesity : targets and therapy",['10.2147/DMSO.S269237']
2886,33061500,Effect of Anthocyanins Supplementation on Serum IGFBP-4 Fragments and Glycemic Control in Patients with Fasting Hyperglycemia: A Randomized Controlled Trial.,"Background


Insulin-like growth factor binding protein-4 (IGFBP-4) fragments have been shown to be associated with cardiometabolic diseases. Anthocyanins as a subgroup of natural polyphenols could have benefits on treating cardiometabolic diseases. The aim of this study was to examine the effects of purified anthocyanins on serum IGFBP-4 fragments and glycemic control in patients with fasting hyperglycemia.
Methods


A set of 121 participants with elevated fasting glucose (≥5.6 mmol/L), who were originally randomly assigned to anthocyanins (320 mg/day) or placebo groups, were included in this study. Serum IGFBP-4 fragments, fasting and postload glucose, insulin, and C-peptide after a three-hour oral glucose tolerance test (OGTT) were measured at baseline and at the end of 12 weeks.
Results


Compared with placebo, anthocyanins increased serum IGFBP-4 fragments (net change 8.33 ng/mL, 95% CI [1.2, 15.47],  p =0.023) and decreased fasting glucose (-0.4 mmol/L [-0.71, -0.1],  p =0.01), 2-hour C-peptide (-1.02 ng/mL [-1.99, -0.04],  p =0.041) and the 3-hour area under the curve (AUC) of C-peptide (-2.19 [-4.11, -0.27],  p =0.026). No other significant difference in parameters for glycemic control and insulin resistance was observed.
Conclusion


Anthocyanins supplementation for 12 weeks improved serum IGFBP-4 fragments and decreased fasting glucose and postload C-peptide in patients with fasting hyperglycemia. Further studies are needed to confirm our findings and clarify the potential mechanism.
Trial Registration


ClinicalTrials.gov, NCT02689765. Registered on 6 February 2016, https://clinicaltrials.gov/ct2/show/NCT02689765.",2020,"Compared with placebo, anthocyanins increased serum IGFBP-4 fragments (net change 8.33 ng/mL, 95% CI [1.2, 15.47],  p =0.023) and decreased fasting glucose (-0.4 mmol/L [-0.71, -0.1],  p =0.01), 2-hour C-peptide","['Patients with Fasting Hyperglycemia', 'patients with fasting hyperglycemia', '121 participants with elevated fasting glucose (≥5.6 mmol/L']","['purified anthocyanins', 'anthocyanins', 'Anthocyanins', 'Anthocyanins supplementation', 'placebo', 'placebo, anthocyanins', 'Anthocyanins Supplementation']","['3-hour area under the curve (AUC) of C-peptide', 'Serum IGFBP-4 Fragments and Glycemic Control', 'serum IGFBP-4 fragments and decreased fasting glucose and postload C-peptide', 'Serum IGFBP-4 fragments, fasting and postload glucose, insulin, and C-peptide after a three-hour oral glucose tolerance test (OGTT', 'serum IGFBP-4 fragments and glycemic control', 'glycemic control and insulin resistance', 'fasting glucose', 'serum IGFBP-4 fragments']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2609269', 'cui_str': 'Fasting hyperglycaemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}]","[{'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0242210', 'cui_str': 'Binding protein'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",,0.197139,"Compared with placebo, anthocyanins increased serum IGFBP-4 fragments (net change 8.33 ng/mL, 95% CI [1.2, 15.47],  p =0.023) and decreased fasting glucose (-0.4 mmol/L [-0.71, -0.1],  p =0.01), 2-hour C-peptide","[{'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Center for Chronic Disease Control, Nanshan, Shenzhen, People's Republic of China.""}, {'ForeName': 'Zhaomin', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': ""Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Center for Chronic Disease Control, Nanshan, Shenzhen, People's Republic of China.""}, {'ForeName': 'Changyi', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Center for Chronic Disease Control, Nanshan, Shenzhen, People's Republic of China.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Center for Chronic Disease Control, Nanshan, Shenzhen, People's Republic of China.""}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': ""Center for Chronic Disease Control, Nanshan, Shenzhen, People's Republic of China.""}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Internal Medicine Department, BaiYun Hospital, GuangZhou, GuangDong Province, People's Republic of China.""}]","Diabetes, metabolic syndrome and obesity : targets and therapy",['10.2147/DMSO.S266751']
2887,33061515,The Effectiveness of Right- vs Left-lateral Starting Position in Unsedated Diagnostic Colonoscopy with Modified-water Immersion Method: A Randomized Controlled Trial Study.,"Objective


A colonoscopy study in sedated patients with air insufflation showed that right-lateral starting position (RLP) improved abdominal discomfort and reduced cecal intubation time. The aim of this study was to determine if RLP vs left-lateral starting position (LLP) may produce similar results in unsedated patients examined with a modified-water immersion (m-WI) method.
Methods


Consecutive patients for diagnostic colonoscopy meeting the inclusion criteria were randomized. Patients and colonoscopist were unblinded. The m-WI method entailed suction during insertion not only for fecal debris evacuation but also to facilitate passage through difficult or angulated colonic flexures. Water was infused as needed when any difficulty was encountered during insertion. A bowel visualization scale (BVS) (0=totally blurred visualization; 1=blurred lumen visualization; 2=small fecal debris with clear mucosa visualization; 3= clear visualization) was used to evaluate the interference of fecal debris with cecal intubation rate and time.
Results


A total of 142 patients (72 in RLP and 70 in LLP) were enrolled. The respective pain score, visual analog scale, (VAS) and cecal intubation rate were not significantly different. The cecal intubation time was nearly significantly different (13.4±4.5 min vs 11.7±5.4 min;  p =0.054) and was significantly different in the constipation subgroup (16.0±3.5 min vs 8.6±3.8 min;  p =0.001). The cecal intubation time based on BVS showed significant difference between RLP and LLP in Scale 2 (13.9±4.6 min vs 10.3±4.2 min;  p =0.003) and Scale 2 and 3 combined (13.2±4.3 min vs 10.6±4.8 min;  p =0.01), respectively.
Conclusion


RLP did not improve the pain score, and LLP showed better performance in unsedated m-WI colonoscopy patients (ClinicalTrial.gov, NCT03489824).",2020,"The respective pain score, visual analog scale, (VAS) and cecal intubation rate were not significantly different.","['sedated patients with air insufflation', 'unsedated patients examined with a modified-water immersion (m-WI) method', 'Unsedated Diagnostic Colonoscopy with Modified-water Immersion Method', '142 patients (72 in RLP and 70 in LLP) were enrolled']","['RLP vs left-lateral starting position (LLP', 'Right- vs Left-lateral Starting Position', 'right-lateral starting position (RLP', 'RLP']","['respective pain score, visual analog scale, (VAS) and cecal intubation rate', 'interference of fecal debris with cecal intubation rate and time', 'cecal intubation time', 'abdominal discomfort and reduced cecal intubation time', 'bowel visualization scale (BVS', 'pain score']","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0420616', 'cui_str': 'Patient examined'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0400018', 'cui_str': 'Diagnostic endoscopic examination on colon'}, {'cui': 'C0450415', 'cui_str': 'Lateral to the right'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}]","[{'cui': 'C0450415', 'cui_str': 'Lateral to the right'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0450414', 'cui_str': 'Lateral to the left'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205090', 'cui_str': 'Right'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0232487', 'cui_str': 'Abdominal discomfort'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",142.0,0.103904,"The respective pain score, visual analog scale, (VAS) and cecal intubation rate were not significantly different.","[{'ForeName': 'Putut', 'Initials': 'P', 'LastName': 'Bayupurnama', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, Universitas Gadjah Mada/Dr Sardjito General Hospital, Yogyakarta, Indonesia.'}, {'ForeName': 'Neneng', 'Initials': 'N', 'LastName': 'Ratnasari', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, Universitas Gadjah Mada/Dr Sardjito General Hospital, Yogyakarta, Indonesia.'}, {'ForeName': 'Fahmi', 'Initials': 'F', 'LastName': 'Indrarti', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, Universitas Gadjah Mada/Dr Sardjito General Hospital, Yogyakarta, Indonesia.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Triwikatmani', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, Universitas Gadjah Mada/Dr Sardjito General Hospital, Yogyakarta, Indonesia.'}, {'ForeName': 'Sutanto', 'Initials': 'S', 'LastName': 'Maduseno', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, Universitas Gadjah Mada/Dr Sardjito General Hospital, Yogyakarta, Indonesia.'}, {'ForeName': 'Siti', 'Initials': 'S', 'LastName': 'Nurdjanah', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, Universitas Gadjah Mada/Dr Sardjito General Hospital, Yogyakarta, Indonesia.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'W Leung', 'Affiliation': 'Sepulveda Ambulatory Care Center, VAGLAHS and David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}]",Clinical and experimental gastroenterology,['10.2147/CEG.S270793']
2888,33061546,Hyperalgesia and Reduced Offset Analgesia During Spinal Anesthesia.,"Introduction


Spinal anesthesia induces short-term deafferentation and causes connectivity changes in brain areas involved in endogenous pain modulation. We determined whether spinal anesthesia alters pain sensitivity and offset analgesia. Offset analgesia is a manifestation of endogenous pain modulation and characterized by profound analgesia upon a small decrease in noxious stimulation.
Methods


In this randomized controlled crossover trial, static thermal pain responses and offset analgesia were obtained in 22 healthy male volunteers during spinal anesthesia and control conditions (absence of spinal anesthesia). Pain responses and offset analgesia were measured on a remote skin area above the upper level of anesthesia (C8/Th1).
Results


Following spinal injection of the local anesthetic, the average maximum anesthesia level was Th6. Static pain scores at C8/Th1 were higher during spinal anesthesia compared to control: 59.1 ± 15.0 mm (spinal anesthesia) versus 51.7 ± 19.7 mm (control; p = 0.03). Offset analgesia responses were decreased during spinal analgesia: pain score decrease 79 ± 27% (spinal anesthesia) versus 90 ± 17% (control; p = 0.016).
Discussion


We confirmed that spinal anesthesia-induced deafferentation causes hyperalgesic responses to noxious thermal stimulation and reduced offset analgesia at dermatomes remote and above the level of deafferentation. While these data suggest that the reduction of offset analgesia has a central origin, related to alterations in brain areas involved in inhibitory pain control, we cannot exclude alternative (peripheral) mechanisms.
Trial Registration


Dutch Cochrane Center under identifier (www.trialregister.nl) NL3874.",2020,Static pain scores at C8/Th1 were higher during spinal anesthesia compared to control: 59.1 ± 15.0 mm (spinal anesthesia) versus 51.7 ± 19.7 mm (control; p = 0.03).,['22 healthy male volunteers during spinal anesthesia and control conditions (absence of spinal anesthesia'],['spinal anesthesia'],"['pain sensitivity and offset analgesia', 'Offset analgesia responses', 'Hyperalgesia and Reduced Offset Analgesia', 'Static pain scores', 'Pain responses and offset analgesia']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332197', 'cui_str': 'Absent'}]","[{'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}]",22.0,0.02923,Static pain scores at C8/Th1 were higher during spinal anesthesia compared to control: 59.1 ± 15.0 mm (spinal anesthesia) versus 51.7 ± 19.7 mm (control; p = 0.03).,"[{'ForeName': 'Elske', 'Initials': 'E', 'LastName': 'Sitsen', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, RC 2300, the Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'van Velzen', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, RC 2300, the Netherlands.'}, {'ForeName': 'Mischa', 'Initials': 'M', 'LastName': 'de Rover', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, RC 2300, the Netherlands.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Dahan', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, RC 2300, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Niesters', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, RC 2300, the Netherlands.'}]",Journal of pain research,['10.2147/JPR.S258533']
2889,33065133,Declaring a gestation nonviable: when 99% certainty is not enough.,"OBJECTIVE


The modern paradigm for diagnosing early pregnancy loss, including ectopic pregnancy, is to compare 2 hCG values to those expected for a growing intrauterine pregnancy. 1  Surveillance of women at risk has led to earlier diagnosis, successful medical management and decreased morbidity and mortality. 2  Confirmation of non-viability is imperative because intervention for diagnosis or treatment with uterine evacuation or methotrexate will terminate a viable gestation or can be teratogenic. Here we describe the hCG results and pregnancy outcome from a participant enrolled in the randomized clinical trial, ACT or NOT (NCT02152696), that evaluated the treatment of women with a persistent pregnancy of unknown location.
STUDY DESIGN


The definition of a persistent pregnancy of unknown location included no definitive ultrasound evidence of intrauterine or extrauterine gestation and a plateau in hCG, defined as a <30%, <50%, <75% or <100% in 2, 3, 4 or 7 days respectively. 3  Two clinicians confirmed eligibility into the trial. Serial hCG levels from the participant were compared to levels used to assess viability of a gestation.
RESULTS


A participant was enrolled, randomized to expectant management, and was later noted to have a viable gestation. A 33-year-old, G2 P1001, who conceived with use of clomiphene citrate and IUI presented with abnormal serial hCG values of 7% in 2 days and 24% over 4 days: 86 at GA 4 0/7, 92 at 4 2/7 and 107 at 4 5/7. All assays were performed in the same laboratory using Roche E170 analyzer. A transvaginal ultrasound performed at 4 5/7 gestation at an accredited academic practice demonstrated no evidence of an intrauterine or extrauterine gestation. Subsequently hCG values rose normally: 348 at 5 0/7, 803 at 5 2/7, and 2477 at 6 0/7. An IUP was diagnosed at 6 5/7 with cardiac activity. She elected to proceed with prenatal care and delivered at term without complication. This event was reported to a DSMB and IRB and judged unanticipated. Serial hCG levels for this participant were plotted against levels from a subset of women with viable gestations (figure). 4  CONCLUSIONS: Estimates of expected rise in hCG were generated from a normative sample of women at risk for pregnancy loss. 4  Current clinical standards assessing viability of an early gestation are based on increases above the 1st percentile of hCG slopes for a growing intrauterine pregnancy: > 23% in one day and > 49% over 2 days (for values <1500 mIU/ml). 4  Conversely, 99% of normal gestations will have at least this rise in hCG. Often this is incorrectly interpreted as a threshold for viability.",2020,"P1001, who conceived with use of clomiphene citrate and IUI presented with abnormal serial hCG values of 7% in 2 days and 24% over 4 days: 86 at GA 4 0/7, 92 at 4 2/7 and 107 at 4 5/7.",['women with a persistent pregnancy of unknown location'],"['methotrexate', 'clomiphene citrate']","['Serial hCG levels', 'morbidity and mortality', 'abnormal serial hCG values']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C3495853', 'cui_str': 'Pregnancy of unknown location'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.206342,"P1001, who conceived with use of clomiphene citrate and IUI presented with abnormal serial hCG values of 7% in 2 days and 24% over 4 days: 86 at GA 4 0/7, 92 at 4 2/7 and 107 at 4 5/7.","[{'ForeName': 'Kurt T', 'Initials': 'KT', 'LastName': 'Barnhart', 'Affiliation': 'University of Pennsylvania School of Medicine, 3701 Market St., Ste. 800 Philadelphia PA 19104. Electronic address: kbarnhart@uphs.upenn.edu.'}, {'ForeName': 'Suneeta', 'Initials': 'S', 'LastName': 'Senapati', 'Affiliation': 'University of Pennsylvania School of Medicine, 3701 Market St., Ste. 800, Philadelphia PA 19104. Electronic address: Ssenapati@uphs.upenn.edu.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': 'Colorado School of Public Health & University of Colorado School of Medicine 13001 E. 17th PI, Ste B119 Aurora, CO 80045. Electronic address: Mary.sammel@cuanschutz.edu.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.10.016']
2890,33065163,Metabolic impact of weight loss induced reduction of adipose ACE-2 - potential implication in COVID-19 infections?,"BACKGROUND & AIMS


Angiotensin converting enzyme (ACE)-2 is a modulator of adipose tissue metabolism. However, human data of adipose ACE-2 is rarely available. Considering that, ACE-2 is believed to be the receptor responsible for cell entry of SARS-CoV-2, a better understanding of its regulation is desirable. We therefore characterized the modulation of subcutaneous adipose ACE-2 mRNA expression during weight loss and the impact of ACE-2 expression on weight loss induced short- and long-term improvements of glucose metabolism.
METHODS


143 subjects (age > 18; BMI ≥ 27 kg/m 2 ) were analyzed before and after a standardized 12-week dietary weight reduction program. Afterwards subjects were randomized to a 12-month lifestyle intervention or a control group (Maintain-Adults trial). Insulin sensitivity (IS) was estimated by HOMA-IR (as an estimate of liver IS) and ISI Clamp  (as an estimate of skeletal muscle IS). ACE-2 mRNA expression (ACE-2 AT ) was measured in subcutaneous adipose tissue before and after weight loss.
RESULTS


ACE-2 AT  was not affected by obesity, but was reduced in insulin resistant subjects. Weight loss resulted in a decline of ACE-2 AT  (29.0 (20.0-47.9) vs. 21.0 (13.0-31.0); p = 1.6 *10 -7 ). A smaller reduction of ACE-2  AT  (ΔACE-2 AT ) was associated with a larger improvement of ISI Clamp  (p = 0.013) during weight reduction over 3 months, but not with the extend of weight loss. The degree of changes in insulin resistance were preserved until month 12 and was also predicted by the weight loss induced degree of ΔACE-2 AT  (p = 0.011).
CONCLUSIONS


Our data indicate that subcutaneous adipose ACE-2 expression correlates with insulin sensitivity. Weight loss induced decline of subcutaneous adipose ACE-2 expression might affect short- and long-term improvement of myocellular insulin sensitivity, which might be also relevant in the context of ACE-2 downregulation by SARS-CoV-2.",2020,"A smaller reduction of ACE-2  AT  (ΔACE-2 AT ) was associated with a larger improvement of ISI Clamp  (p = 0.013) during weight reduction over 3 months, but not with the extend of weight loss.",['143 subjects (age\u202f>\u202f18; BMI\u202f≥\u202f27\u202fkg/m 2 '],"['lifestyle intervention', 'ACE-2']","['Insulin sensitivity (IS', 'ACE-2  AT  (ΔACE-2 AT ', 'degree of changes in insulin resistance', 'Weight loss', 'ISI Clamp', 'ACE-2 mRNA expression (ACE-2 AT ']","[{'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",143.0,0.0156104,"A smaller reduction of ACE-2  AT  (ΔACE-2 AT ) was associated with a larger improvement of ISI Clamp  (p = 0.013) during weight reduction over 3 months, but not with the extend of weight loss.","[{'ForeName': 'Linna', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Clinical Research Unit, 10117 Berlin, Germany.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Spranger', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany.'}, {'ForeName': 'Soll', 'Initials': 'S', 'LastName': 'Dominik', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany.'}, {'ForeName': 'Finja', 'Initials': 'F', 'LastName': 'Beer', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Brachs', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charité Center for Cardiovascular Research, 10117 Berlin, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Spranger', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charité Center for Cardiovascular Research, 10117 Berlin, Germany; DZHK (German Centre for Cardiovascular Research), partner site Berlin. Electronic address: joachim.spranger@charite.de.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Mai', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charité Center for Cardiovascular Research, 10117 Berlin, Germany; DZHK (German Centre for Cardiovascular Research), partner site Berlin; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Clinical Research Unit, 10117 Berlin, Germany.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154401']
2891,33065186,"Results of Phase II Trial of Intensified Neoadjuvant Treatment with Interdigitating Radiotherapy and Chemotherapy with Oxaliplatin, 5-Fluorouracil and Folinic Acid in Patients with Locally Advanced Rectal Cancer (PROARCT trial).","BACKGROUND AND PURPOSE


The chemotherapy exposure during chemoradiotherapy for rectal cancer is adequate for radiosensitization but suboptimal for treatment of distant micrometastasis. This study aimed to determine tolerability, dose intensity, response, and toxicity of a novel intensified neoadjuvant treatment approach.
MATERIALS AND METHODS


Eligible patients were MRI-staged T3-4NxM0 rectal adenocarcinoma. Treatment consisted of FOLFOX chemotherapy given in weeks 1, 6, and 11 with pelvic radiotherapy (25.2Gy in 3 weeks in 1.8Gy/ fraction with oxaliplatin and 5-FU continuous infusion) given in weeks 3-5, and weeks 8-10. Surgery was performed 4 to 6 weeks later. The primary endpoint was tolerability defined as the percentage of patients who were able to complete the planned treatment course. Survival rates were estimated using the Kaplan-Meier method.
RESULTS


Median age of the 40 patients was 61.5 years. Rectal MRI-stage was T3 in 88%. Overall, 95% completed the regimen. All patients received 50.4Gy. Relative dose intensity (≥75%) was 92% and 98% for oxaliplatin and 5-FU, respectively. High grade toxicities included neutropenia (25% grade 3; 7.5% grade 4) and diarrhea (10%). Pathologic CR rate was 20%. Median follow-up was 54 months. The 5-year overall survival, freedom from relapse, locoregional control, and freedom from distant metastasis of the cohort was 82%, 72%, 97% and 72%.
CONCLUSIONS


Delivery of intensified neoadjuvant treatment with interdigitating chemotherapy and radiotherapy is feasible with no increase in acute perioperative complications. A larger prospective study is required to further evaluate the potential survival benefit of this design.",2020,"The 5-year overall survival, freedom from relapse, locoregional control, and freedom from distant metastasis of the cohort was 82%, 72%, 97% and 72%.
","['Median age of the 40 patients was 61.5 years', 'Eligible patients were MRI-staged T3-4NxM0 rectal adenocarcinoma', 'Patients with Locally Advanced Rectal Cancer (PROARCT trial']","['interdigitating chemotherapy and radiotherapy', 'oxaliplatin and 5-FU', 'pelvic radiotherapy (25.2Gy in 3 weeks in 1.8Gy/ fraction with oxaliplatin and 5-FU continuous infusion', 'FOLFOX chemotherapy', 'Interdigitating Radiotherapy and Chemotherapy with Oxaliplatin, 5-Fluorouracil and Folinic Acid']","['diarrhea', 'acute perioperative complications', 'High grade toxicities included neutropenia', 'Pathologic CR rate', '5-year overall survival, freedom from relapse, locoregional control, and freedom from distant metastasis', 'tolerability', 'Rectal MRI-stage', 'tolerability, dose intensity, response, and toxicity', 'Survival rates']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0149978', 'cui_str': 'Adenocarcinoma of rectum'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.143359,"The 5-year overall survival, freedom from relapse, locoregional control, and freedom from distant metastasis of the cohort was 82%, 72%, 97% and 72%.
","[{'ForeName': 'Sweet', 'Initials': 'S', 'LastName': 'Ping Ng', 'Affiliation': 'Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne Victoria Australia; Department of Radiation Oncology, Olivia Newton-John Cancer Centre, Austin Health, Melbourne Victoria Australia. Electronic address: sweet.ng@petermac.org.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Chu', 'Affiliation': 'Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne Victoria Australia.'}, {'ForeName': 'Sarat', 'Initials': 'S', 'LastName': 'Chander', 'Affiliation': 'Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne Victoria Australia.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Bressel', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne Victoria Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'McKendrick', 'Affiliation': 'Department of Medical Oncology, Eastern Health, Box Hill Hospital, Victoria Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wong', 'Affiliation': 'Department of Medical Oncology, Eastern Health, Box Hill Hospital, Victoria Australia; Monash University, Eastern Health Clinical School, Box Hill, Victoria Australia.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Steel', 'Affiliation': 'Department of Colorectal Surgery, Box Hill Hospital, Melbourne Victoria Australia.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Murray', 'Affiliation': 'Department of Pathology, Peter MacCallum Cancer Centre, Melbourne Victoria Australia.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Leong', 'Affiliation': 'Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne Victoria Australia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Heriot', 'Affiliation': 'Department of Surgical Oncology, Peter MacCallum Cancer Centre, Melbourne Victoria Australia; The Sir Peter MacCallum Department of Oncology, University of Melbourne.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Michael', 'Affiliation': 'Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne Victoria Australia; The Sir Peter MacCallum Department of Oncology, University of Melbourne.'}, {'ForeName': 'Samuel Y', 'Initials': 'SY', 'LastName': 'Ngan', 'Affiliation': 'Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne Victoria Australia. Electronic address: sam.ngan@petermac.org.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.10.012']
2892,33065191,A Randomized Controlled Trial Testing the Effects of A Positive Front-of-Pack Label With or Without a Physical Activity Equivalent Label on Food Purchases.,"BACKGROUND


Positive front-of-pack (FOP) labels are intended to help shoppers identify healthier products. However, there is a lack of evidence on the effectiveness of these labels on actual purchases. We assess the effectiveness of one positive FOP label, Singapore's Healthier Choice Symbol (HCSs), on food purchases and diet quality with and without added calorie information using a Physical Activity Equivalent (PAE) label.
METHODS


We conducted a randomized controlled trial using a 3 arm within-subject crossover design in adult Singapore residents who were recruited online. Participants were expected to shop once in each condition on an experimental online grocery store in random order: 1) no FOP label (Control); 2) Select products displaying HCS labels (HCS-only); 3) Condition 2 with additional information displaying PAEs per serving on every product (HCS+PAE). In total, 117 participants were recruited and data from 107 shops were analyzed. We used first-differenced regressions to assess the impact of the conditions on calories per serving (primary) and on other measures of diet quality.
RESULTS


The HCS-only condition led to a statistically significant five-percentage point increase in the proportion of HCS products purchased (95% CI, 1%: 9%). However, neither the HCS-only (3.45; 95% CI, -12.52: 19.43) nor HCS+PAE (8.14; 95% CI, -5.25: 21.54) condition led to a change in the number of calories per serving purchased or changes in other measures of diet quality.
CONCLUSIONS


Positive labels, like the HCS, are likely to increase purchases of labelled products. However, these changes may not lead to improvements in diet quality or calorie intake. Combining positive labels with additional PAE information does not appear to address this concern.",2020,"The HCS-only condition led to a statistically significant five-percentage point increase in the proportion of HCS products purchased (95% CI, 1%: 9%).","['117 participants were recruited and data from 107 shops were analyzed', 'adult Singapore residents who were recruited online']","['Physical Activity Equivalent (PAE) label', 'Positive Front-of-Pack Label', 'FOP label (Control', '2) Select products displaying HCS labels (HCS-only); 3) Condition 2 with additional information displaying PAEs per serving on every product (HCS+PAE', ""positive FOP label, Singapore's Healthier Choice Symbol (HCSs""]",['diet quality or calorie intake'],"[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0041472', 'cui_str': 'Murine typhus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032052', 'cui_str': 'Human placental lactogen'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0010996', 'cui_str': 'Information Display'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",117.0,0.203633,"The HCS-only condition led to a statistically significant five-percentage point increase in the proportion of HCS products purchased (95% CI, 1%: 9%).","[{'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore; Saw Swee Hock School of Public Health, National University of Singapore, Singapore. Electronic address: eric.finkelstein@duke-nus.edu.sg.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Doble', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Felicia Jia', 'Initials': 'FJ', 'LastName': 'Ler Ang', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Wei Han', 'Initials': 'WH', 'LastName': 'Melvin Wong', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Rob M', 'Initials': 'RM', 'LastName': 'van Dam', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}]",Appetite,['10.1016/j.appet.2020.104997']
2893,33065208,Yoga Practice Predicts Improvements in Day-to-Day Pain in Women with Metastatic Breast Cancer.,"CONTEXT


Women with metastatic breast cancer (MBC) experience a significant symptom burden, including cancer pain. Yoga is a mind-body discipline that has shown promise for alleviating cancer pain, but few studies have included patients with metastatic disease or examined the acute effects of yoga practice.
OBJECTIVES


To determine whether daily pain changed significantly during a randomized controlled trial of the Mindful Yoga program among women with MBC, and whether time spent in yoga practice was related to daily pain.
METHODS


On alternate weeks during the intervention period, we collected daily measures of pain from a subset of 48 women randomized to either yoga (n = 30) or a support group condition (n = 18). We also assessed daily duration of yoga practice among patients randomized to yoga.
RESULTS


Pain levels were low for women in both conditions, and no differential treatment effects were found on daily pain. However, among women randomized to yoga, a dose/response relationship was found between yoga practice duration, and daily pain. When patients had spent relatively more time practicing yoga across two consecutive days, they were more likely to experience lower pain on the following day. This finding is consistent with an earlier MBC study. Meditation practice showed the strongest association with lower daily pain.
CONCLUSION


Findings suggest that yoga practice (meditation practice in particular) is associated with acute improvements in cancer pain, and that yoga interventions may be more impactful if tested in a sample of advanced cancer patients in which pain is relatively elevated.",2020,"RESULTS


Pain levels were low for women in both conditions, and no differential treatment effects were found on daily pain.","['Women with Metastatic Breast Cancer', 'Women with metastatic breast cancer', 'women with MBC', 'advanced cancer patients']",['Mindful Yoga program'],"['Pain levels', 'yoga practice duration, and daily pain', 'cancer pain', 'daily pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}]",48.0,0.0669837,"RESULTS


Pain levels were low for women in both conditions, and no differential treatment effects were found on daily pain.","[{'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Carson', 'Affiliation': 'Department of Anesthesiology & Perioperative Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd., Portland, OR 97239, USA. Electronic address: carsonja@ohsu.edu.'}, {'ForeName': 'Kimberly M', 'Initials': 'KM', 'LastName': 'Carson', 'Affiliation': 'Department of Anesthesiology & Perioperative Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd., Portland, OR 97239, USA.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Olsen', 'Affiliation': 'Center for Health Services Research in Primary Care, Durham VA Medical Center, Durham, NC 27705, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Sanders', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Box 2628, Durham, NC 27710, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Westbrook', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Box 3459, Durham, NC 27710, USA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Box 90399, Durham, NC 27708, USA.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Box 90399, Durham, NC 27708, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.10.009']
2894,33065358,Qualitative process evaluation of the Fostering Changes program for foster carers as part of the Confidence in Care randomized controlled trial.,"BACKGROUND


Fostering Changes is an in-service training program for foster carers designed to enhance carer skills, coping strategies and carer-child relationships. The training program has been evaluated in a randomised controlled trial comparing Fostering Changes to usual care.
OBJECTIVE


To conduct a qualitative process evaluation drawing on stakeholder perspectives to describe the logic model of Fostering Changes, identify potential mechanisms of impact of the program and enhance understanding of the trial results.
PARTICIPANTS AND SETTING


Participants were stakeholders in the Fostering Changes program delivered in Wales, UK including foster carers invited to attend the program (18 attendees, eight non-attendees), two program developers, five trainers, 12 social workers who attended or recruited to the program.
METHODS


Total population sampling with qualitative data collection methods. Qualitative data were subject to thematic analysis.
RESULTS


A logic model summarising the program resources, activities and anticipated outcomes was generated. Implementation themes were quality of training, setting and group composition. Mechanisms of impact were identified with themes falling into two categories, group process and skills development. Potential barriers to effectiveness included a poor fit between the carer needs and the program in relation to levels of challenge being faced, age-appropriate content and responsiveness. Contextual factors were also relevant, including the existing relationship between foster carers and the agency and the perceived value of training.
CONCLUSIONS


Although the group aspects of the program were well received, the program itself did not help foster carers deal with more complex challenges and needed to be more targeted in terms of carers needs and circumstances.",2020,"Although the group aspects of the program were well received, the program itself did not help foster carers deal with more complex challenges and needed to be more targeted in terms of carers needs and circumstances.","['Participants were stakeholders in the Fostering Changes program delivered in Wales, UK including foster carers invited to attend the program (18 attendees, eight non-attendees), two program developers, five trainers, 12 social workers who attended or recruited to the program', 'Total population sampling with qualitative data collection methods']",['Fostering Changes program'],[],"[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C3887707', 'cui_str': 'Data Collection Methods'}]","[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0305087,"Although the group aspects of the program were well received, the program itself did not help foster carers deal with more complex challenges and needed to be more targeted in terms of carers needs and circumstances.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Channon', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: ChannonS2@cardiff.ac.uk.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Coulman', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: JohnE1@cardiff.ac.uk.'}, {'ForeName': 'Gwenllian', 'Initials': 'G', 'LastName': 'Moody', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: MoodyG@cardiff.ac.uk.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Brookes-Howell', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: Brookes-HowellLC@cardiff.ac.uk.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cannings-John', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: CanningsRL@cardiff.ac.uk.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Lau', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: LauTM@cardiff.ac.uk.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Rees', 'Affiliation': ""Children's Social Care Research and Development Centre (CASCADE), School of Social Sciences, Cardiff University, United Kingdom. Electronic address: ReesA1@cardiff.ac.uk.""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Segrott', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom. Electronic address: SegrottJ@cardiff.ac.uk.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Scourfield', 'Affiliation': ""Children's Social Care Research and Development Centre (CASCADE), School of Social Sciences, Cardiff University, United Kingdom; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom. Electronic address: Scourfield@cardiff.ac.uk.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom. Electronic address: RoblingMR@cardiff.ac.uk.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104768']
2895,33061347,Efficacy of Unsupervised Home-Based Pulmonary Rehabilitation for Patients with Chronic Obstructive Pulmonary Disease.,"Purpose


Pulmonary rehabilitation (PR) is a well-established treatment for chronic obstructive pulmonary disease (COPD). The standard protocol for PR requires frequent hospital visits, which can be difficult for patients. We performed this study to assess whether unsupervised home-based PR (HBPR) is effective for patients with COPD.
Patients and Methods


After assessing the outcome data, including the results of a COPD assessment test (CAT); the body mass index, airflow obstruction, dyspnea, and exercise capacity (BODE) index; a spirometry; the modified Medical Research Council (mMRC) dyspnea scale; and the 6-min walking test (6MWT), specialists imparted 1-hour education to patients regarding unsupervised HBPR at the baseline visit. This included methods for breathing, inhaler use, stretching, and exercise. On reviewing diaries after 8 weeks from the first visit, patients who exercised at least thrice per week were classified as the compliant group and the others were categorized as the noncompliant group. Changes in the outcomes were compared between the compliant and noncompliant groups.
Results


A total of 41 patients were enrolled in this study; for 8 weeks of unsupervised HBPR, there were significant improvements in CAT scores (-4.62±4.61 vs 2.40±6.73;  P =0.002), BODE index (-1.00±1.06 vs -0.20±0.56;  P =0.01), and forced expiratory volume in 1 s (0.05±0.19 vs -0.09±0.16;  P =0.02) among patients in the compliant group, compared with the noncompliant group. Moreover, their CAT (16.46±7.80 vs 11.85±7.23;  P =0.03) and mMRC scores (2.54±0.76 vs 1.81±0.63;  P =0.001) improved significantly after 8 weeks, compared with those at baseline. On the other hand, patients in the noncompliant group showed no significant improvement in any of the outcomes.
Conclusion


In this study, compliant patients with unsupervised HBPR achieved favorable outcomes in 8 weeks. Thus, we recommend unsupervised HBPR for patients with COPD, even when regular hospital visits for PR are not possible.
Trial Registration


NCT03754881.",2020,"Moreover, their CAT (16.46±7.80 vs 11.85±7.23;  P =0.03) and mMRC scores (2.54±0.76 vs 1.81±0.63;  P =0.001) improved significantly after 8 weeks, compared with those at baseline.","['chronic obstructive pulmonary disease (COPD', '41 patients', 'patients with COPD', 'Patients with Chronic Obstructive Pulmonary Disease']","['Pulmonary rehabilitation (PR', 'Unsupervised Home-Based Pulmonary Rehabilitation', 'unsupervised home-based PR (HBPR']","['BODE index', 'forced expiratory volume', 'CAT scores', 'mMRC scores', 'COPD assessment test (CAT); the body mass index, airflow obstruction, dyspnea, and exercise capacity (BODE) index; a spirometry; the modified Medical Research Council (mMRC) dyspnea scale; and the 6-min walking test (6MWT), specialists imparted 1-hour education to patients regarding unsupervised HBPR']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",41.0,0.053022,"Moreover, their CAT (16.46±7.80 vs 11.85±7.23;  P =0.03) and mMRC scores (2.54±0.76 vs 1.81±0.63;  P =0.001) improved significantly after 8 weeks, compared with those at baseline.","[{'ForeName': 'Jang Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyang Yi', 'Initials': 'HY', 'LastName': 'Lee', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Youngwon', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yeon-Mok', 'Initials': 'YM', 'LastName': 'Oh', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-Do', 'Initials': 'SD', 'LastName': 'Lee', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sei Won', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S268683']
2896,33061349,"Clinically Important Deterioration Among Patients with Chronic Obstructive Pulmonary Disease (COPD) Treated with Nebulized Glycopyrrolate: A Post Hoc Analysis of Pooled Data from Two Randomized, Double-Blind, Placebo-Controlled Studies.","Purpose


Using a composite endpoint, pooled data from two 12-week Phase III placebo-controlled trials (GOLDEN 3, NCT02347761; GOLDEN 4, NCT02347774) were analyzed to determine whether glycopyrrolate inhalation solution (25 mcg and 50 mcg) administered twice daily (BID) via the eFlow ®  Closed System nebulizer (GLY) reduced the risk of clinically important deterioration (CID) in patients with moderate-to-very-severe COPD.
Methods


CID was defined as ≥100-mL decrease from baseline in post-bronchodilator trough forced expiratory volume in one second (FEV 1 ), or ≥4-unit increase in baseline St. George's Respiratory Questionnaire (SGRQ) total score, or moderate/severe exacerbation. The relative treatment effect of GLY versus placebo on the odds of CID (any and by component endpoints) was expressed as the odds ratio (OR) and 95% confidence interval (CI). Subgroups categorized by age (<65/≥65 years), sex, smoking status (current/former), long-acting beta agonist (LABA) use, FEV 1  (<50%/≥50%), and peak inspiratory flow rate (PIFR) (<60 L/min/≥60 L/min) were analyzed.
Results


Compared to placebo, GLY 25 mcg and 50 mcg BID over 12 weeks significantly reduced the risk of CID by 50% (OR: 0.50 [0.37-0.68]) and 40% (OR: 0.60 [0.44-0.80]), respectively. Subjects treated with GLY 25 mcg BID were 59% less likely to experience CID in FEV 1  (OR: 0.41 [0.27-0.62]) and 48% less likely to perceive CID in health status (OR: 0.52 [0.37-0.73]). Statistically significant reductions were also observed at the higher dose. The incidence of moderate/severe exacerbations was low and comparable among the cohorts. GLY 25 mcg BID was significantly more effective than placebo (p<0.05) in preventing CID irrespective of age, smoking status, LABA use, COPD severity, or PIFR. Subjects <65 years (OR 0.45 [0.29-0.68]) and those with PIFR <60 L/min (OR 0.36 [0.20-0.67]) exhibited the largest benefit.
Conclusion


Nebulized GLY over 12 weeks significantly reduced the risk of CID and provided greater short-term stability in patients with moderate-to-very-severe COPD.",2020,"GLY 25 mcg BID was significantly more effective than placebo (p<0.05) in preventing CID irrespective of age, smoking status, LABA use, COPD severity, or PIFR.","['Patients with Chronic Obstructive Pulmonary Disease (COPD) Treated with', 'Subgroups categorized by age (<65/≥65 years), sex, smoking status (current/former), long-acting beta agonist (LABA) use', 'patients with moderate-to-very-severe COPD']","['Nebulized GLY', 'glycopyrrolate inhalation solution (25 mcg and 50 mcg) administered twice daily (BID) via the eFlow ®', 'GLY versus placebo', 'Closed System nebulizer ', 'placebo', 'placebo, GLY', 'Nebulized Glycopyrrolate', 'GLY 25 mcg BID', 'Placebo']","['risk of CID', 'risk of CID and provided greater short-term stability', ""baseline St. George's Respiratory Questionnaire (SGRQ) total score, or moderate/severe exacerbation"", 'peak inspiratory flow rate (PIFR', 'incidence of moderate/severe exacerbations', 'CID irrespective of age, smoking status, LABA use, COPD severity, or PIFR', 'risk of clinically important deterioration (CID']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}]","[{'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C1154181', 'cui_str': 'Solution for inhalation'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0027524', 'cui_str': 'Nebulizer'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0429742', 'cui_str': 'Peak inspiratory flow rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.455208,"GLY 25 mcg BID was significantly more effective than placebo (p<0.05) in preventing CID irrespective of age, smoking status, LABA use, COPD severity, or PIFR.","[{'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Kerwin', 'Affiliation': 'Clinical Research Institute of Southern Oregon, Medford, OR, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Murray', 'Affiliation': 'Evidera, Bethesda, MD, USA.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Niu', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Dembek', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S267249']
2897,33061398,Effect of Switching from Low-Dose Simvastatin to High-Dose Atorvastatin on Glucose Homeostasis and Cognitive Function in Type 2 Diabetes.,"Background


High-intensity statin is recommended in high-risk type 2 diabetes (T2D); however, statin dose dependently increases the risk of developing new-onset diabetes, can potentially worsen glycemic control in T2D, and may cause cognitive impairment. This study aimed to investigate the effect of statin intensification on glucose homeostasis and cognitive function in T2D.
Materials and Methods


T2D patients who were taking simvastatin ≤20 mg/day were randomized to continue taking the same dosage of simvastatin (low-dose simvastatin group; LS, n=63) for 12 weeks, or to change to atorvastatin 40 mg/day for 6 weeks, and if tolerated, atorvastatin was increased to 80 mg/day for 6 weeks (high-dose atorvastatin group; HS, n=62). Fasting plasma glucose (FPG), glycated hemoglobin (HbA 1c ), plasma insulin, homeostatic model assessment of insulin resistance (HOMA-IR) and of β-cell function (HOMA-B), cognitive functions using Montreal Cognitive Assessment (MoCA), and Trail Making Test (TMT) were assessed at baseline, 6 weeks, and 12 weeks.
Results


Mean age of patients was 58.8±8.9 years, and 72% were female. Mean baseline FPG and HbA 1c  were 124.0±27.5 mg/dl and 6.9±0.8%, respectively. No differences in baseline characteristics between groups were observed. Change in HbA 1c  from baseline in the LS and HS groups was -0.1% and +0.1% ( p =0.03) at 6 weeks, and -0.1% and +0.1% ( p =0.07) at 12 weeks. There were no significant differences in FPG, fasting plasma insulin, HOMA-B, HOMA-IR, MoCA score, or TMT between groups at 6 or 12 weeks.
Conclusion


Switching from low-dose simvastatin to high-dose atorvastatin in T2D resulted in a slight increase in HbA 1c  (0.1%) without causing cognitive decline.",2020,"There were no significant differences in FPG, fasting plasma insulin, HOMA-B, HOMA-IR, MoCA score, or TMT between groups at 6 or 12 weeks.
","['≤20 mg/day', 'T2D.\nMaterials and Methods\n\n\nT2D patients who were taking', 'Mean age of patients was 58.8±8.9 years, and 72% were female', 'Type 2 Diabetes']","['\n\n\nHigh-intensity statin', 'simvastatin (low-dose simvastatin', 'atorvastatin', 'Switching from Low-Dose Simvastatin to High-Dose Atorvastatin', 'simvastatin', 'statin intensification']","['Change in HbA 1c', 'Glucose Homeostasis and Cognitive Function', 'Mean baseline FPG and HbA 1c', 'FPG, fasting plasma insulin, HOMA-B, HOMA-IR, MoCA score, or TMT', 'Fasting plasma glucose (FPG), glycated hemoglobin (HbA 1c ), plasma insulin, homeostatic model assessment of insulin resistance (HOMA-IR) and of β-cell function (HOMA-B), cognitive functions using Montreal Cognitive Assessment (MoCA), and Trail Making Test (TMT', 'glucose homeostasis and cognitive function']","[{'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}]",,0.0177678,"There were no significant differences in FPG, fasting plasma insulin, HOMA-B, HOMA-IR, MoCA score, or TMT between groups at 6 or 12 weeks.
","[{'ForeName': 'Nuntakorn', 'Initials': 'N', 'LastName': 'Thongtang', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Natthakan', 'Initials': 'N', 'LastName': 'Tangkittikasem', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kittichai', 'Initials': 'K', 'LastName': 'Samaithongcharoen', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Jirasak', 'Initials': 'J', 'LastName': 'Piyapromdee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Varalak', 'Initials': 'V', 'LastName': 'Srinonprasert', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sutin', 'Initials': 'S', 'LastName': 'Sriussadaporn', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Vascular health and risk management,['10.2147/VHRM.S270751']
2898,33061414,Proteins and Amino Acids Treated with Atmospheric Plasma Show Significantly Increased Bioavailability in Humans.,"Background


Muscle mass is an important determinant of metabolic health and physical function. It has previously been demonstrated that the postprandial rise in circulating essential amino acids acts as the main stimulus for muscle protein synthesis (MPS). The current study investigated the postprandial plasma essential amino acid (EAA) and branched-chain amino acid (BCAA) responses of (1) Hydrolyzed whey protein isolate (HWPI) compared to plasma treated non-hydrolyzed whey protein isolate (PT-NHWPI), (2) standard branch-chain amino acids (S-BCAA) compared to plasma treated branch-chained amino acids (PT-BCAA), (3) standard pea protein (S-PP), compared to plasma treated pea protein (PT-PP), and (4) HWPI compared to PT-PP.
Methods


Ten subjects (24.6 ± 5.3 years; 178.8 ± 8.1 cm; 78.6 ± 10.1 kg) participated in a double-blind, randomized, crossover trial comparing four separate protein conditions (HWPI, PT-NHWPI, S-PP, PT-PP). A separate cohort of ten subjects (26.4 ± 7.4 years; 178.8 ± 5.9 cm; 85 ± 12.3 kg) participated in a double-blind randomized, crossover trial comparing two branch-chain amino acid conditions: S-BCAA and PT-BCAA. All conditions were administered following a 7-day washout. Plasma EAA and BCAA concentrations were assessed from blood donated by subjects at pre-consumption, 30-, 60-, 90-, 120-, and 180 minutes post-consumption.
Results


Blood plasma levels of total EAA and BCAA concentration were significantly greater in all treated conditions at 30-, 60-, 90-, and 120 minutes post consumption ( P  < .05). There were no differences between PT-PP and HWPI.
Discussion


All proteins significantly elevated EAAs, and BCAAs from basal levels. However, we conclude that the consumption of the treated proteins significantly raises blood levels of EAAs, and BCAAs to a greater extent across multiple dairy, vegan, and isolated BCAA conditions. Moreover, atmospheric plasma treatment of a vegan protein source makes its amino acid response similar to whey. Thus, protein supplementation with that has undergone Ingredient Optimized® atmospheric plasma treatment technology may be highly beneficial for improving the blood plasma amino acid response.",2020,"Results


Blood plasma levels of total EAA and BCAA concentration were significantly greater in all treated conditions at 30-, 60-, 90-, and 120 minutes post consumption ( P  < .05).","['A separate cohort of ten subjects (26.4\u2009±\u20097.4\u2009years; 178.8\u2009±\u20095.9\u2009cm; 85\u2009±\u200912.3\u2009kg', 'Methods\n\n\nTen subjects (24.6\u2009±\u20095.3\u2009years; 178.8\u2009±\u20098.1\u2009cm; 78.6\u2009±\u200910.1\u2009kg']",['branch-chain amino acid conditions: S-BCAA and PT-BCAA'],"['blood plasma amino acid response', 'Bioavailability', 'elevated EAAs, and BCAAs from basal levels', 'Blood plasma levels of total EAA and BCAA concentration', 'Plasma EAA and BCAA concentrations', 'postprandial plasma essential amino acid (EAA) and branched-chain amino acid (BCAA) responses', 'blood levels of EAAs, and BCAAs']","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C4517875', 'cui_str': '8.1'}]","[{'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",,0.0458029,"Results


Blood plasma levels of total EAA and BCAA concentration were significantly greater in all treated conditions at 30-, 60-, 90-, and 120 minutes post consumption ( P  < .05).","[{'ForeName': 'Matthew H', 'Initials': 'MH', 'LastName': 'Sharp', 'Affiliation': 'The Applied Science & Performance Institute, Tampa, FL, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Stefan', 'Affiliation': 'The Applied Science & Performance Institute, Tampa, FL, USA.'}, {'ForeName': 'Raad H', 'Initials': 'RH', 'LastName': 'Gheith', 'Affiliation': 'The Applied Science & Performance Institute, Tampa, FL, USA.'}, {'ForeName': 'Dallen D', 'Initials': 'DD', 'LastName': 'Reber', 'Affiliation': 'The Applied Science & Performance Institute, Tampa, FL, USA.'}, {'ForeName': 'Charlie R', 'Initials': 'CR', 'LastName': 'Ottinger', 'Affiliation': 'The Applied Science & Performance Institute, Tampa, FL, USA.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Wilson', 'Affiliation': 'The Applied Science & Performance Institute, Tampa, FL, USA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Lowery', 'Affiliation': 'The Applied Science & Performance Institute, Tampa, FL, USA.'}]",Nutrition and metabolic insights,['10.1177/1178638820949239']
2899,33054487,"The Development and Feasibility of TECH: Tablet Enhancement of Cognition and Health, a Novel Cognitive Intervention for People with Mild Cognitive Impairment.","Objectives:  Cognitive training using technology has potential to be an effective treatment method for people with mild cognitive impairment (MCI). Touchscreen tablet applications might provide a fun and motivating way to engage in cognitive training for people with MCI. This study presents the development of TECH: ""Tablet Enhancement of Cognition and Health,"" a novel cognitive intervention utilizing touchscreen tablet applications for self-training, and we aimed to examine TECH's feasibility and satisfaction for older adults with MCI.  Materials and Methods:  TECH development was based on the review of research evidence to identify important demands for effective cognitive training, and discussions with occupational therapists with experience using touchscreen tablets for treating individuals with cognitive impairments. Feasibility of TECH was assessed in terms of adherence (session attendance), compliance (total self-training hours), and satisfaction from the intervention.  Results:  Twenty-eight community-dwelling older adults with MCI participated in the study and received TECH. Participants attended at least 80% of group sessions, they self-trained a mean (standard deviation [SD]) 20.9 (7.2) sessions for 5 weeks, mean (SD) total training time of 24.4 (11.9) hours, 4.9 h/week. Very high satisfaction with the intervention was reported by 78% of the 23 participants who filled in the questionnaire.  Conclusions:  The newly developed TECH intervention was found to be feasible for older adults with MCI. Participants were willing and able to perform the self-training at home, which provided a motivating cognitive leisure activity facilitated by weekly group sessions. Data are now collected to establish the effectiveness of TECH as a cognitive intervention, compared with a control group, for people with MCI.",2020,"Data are now collected to establish the effectiveness of TECH as a cognitive intervention, compared with a control group, for people with MCI.","['Results:  Twenty-eight community-dwelling older adults with MCI participated in the study and received', 'people with mild cognitive impairment (MCI', 'older adults with MCI', '23 participants who filled in the questionnaire', 'People with Mild Cognitive Impairment', 'people with MCI', 'individuals with cognitive impairments']","['TECH intervention', 'TECH', 'Cognitive training using technology']","['adherence (session attendance), compliance (total self-training hours), and satisfaction']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0560005', 'cui_str': 'mCi'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0168343,"Data are now collected to establish the effectiveness of TECH as a cognitive intervention, compared with a control group, for people with MCI.","[{'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Givon Schaham', 'Affiliation': 'Department of Occupational Therapy, Sackler Faculty of Medicine, Steyer School of Health Professions, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Vitek', 'Affiliation': 'Department of Occupational Therapy, Sackler Faculty of Medicine, Steyer School of Health Professions, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Donda', 'Affiliation': 'Department of Occupational Therapy, Sackler Faculty of Medicine, Steyer School of Health Professions, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Elbo Golan', 'Affiliation': 'Maccabi Healthcare Services, Tel Aviv, Israel.'}, {'ForeName': 'Zvi', 'Initials': 'Z', 'LastName': 'Buckman', 'Affiliation': 'Maccabi Healthcare Services, Tel Aviv, Israel.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Rand', 'Affiliation': 'Department of Occupational Therapy, Sackler Faculty of Medicine, Steyer School of Health Professions, Tel Aviv University, Tel Aviv, Israel.'}]",Games for health journal,['10.1089/g4h.2019.0157']
2900,33054488,Evaluation of a Cognitive-Behavioral Game Design-Based Mobile Game on Alcohol Use for Adolescents.,Objective:  Determine the effectiveness of a cognitive behavioral game design (CBGD) based mobile game as an alcohol use intervention.  Materials and Methods:  Experimental design with 140 participants randomly assigned to either play a mobile game ( n  = 69) or watch a video documentary ( n  = 71).  Results:  Both groups displayed a decrease in intent to use and an increase in knowledge. The video intervention was superior in affecting actual use.  Conclusion:  Mobile game affects intent to use and is superior to the video in affecting knowledge.,2020,Both groups displayed a decrease in intent to use and an increase in knowledge.,"['Adolescents', '140 participants randomly assigned to either']","['cognitive behavioral game design (CBGD) based mobile game', 'play a mobile game ( n \u2009=\u200969) or watch a video documentary', 'Cognitive-Behavioral Game Design-Based Mobile Game']",['knowledge'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}]",140.0,0.0293746,Both groups displayed a decrease in intent to use and an increase in knowledge.,"[{'ForeName': 'Anton Gabriel H', 'Initials': 'AGH', 'LastName': 'Yap', 'Affiliation': 'Department of Psychology, Ateneo de Manila University, Quezon City, Philippines.'}, {'ForeName': 'Rodrigo Emmanuel D', 'Initials': 'RED', 'LastName': 'Roy', 'Affiliation': 'Department of Psychology, Ateneo de Manila University, Quezon City, Philippines.'}, {'ForeName': 'Jose Rafael S', 'Initials': 'JRS', 'LastName': 'Lasala', 'Affiliation': 'Department of Psychology, Ateneo de Manila University, Quezon City, Philippines.'}, {'ForeName': 'Divine-Kia', 'Initials': 'DK', 'LastName': 'Tan', 'Affiliation': 'Department of Psychology, Ateneo de Manila University, Quezon City, Philippines.'}, {'ForeName': 'Ma Regina', 'Initials': 'MR', 'LastName': 'Hechanova', 'Affiliation': 'Department of Psychology, Ateneo de Manila University, Quezon City, Philippines.'}, {'ForeName': 'Walfrido David A', 'Initials': 'WDA', 'LastName': 'Diy', 'Affiliation': 'Department of Psychology, Ateneo de Manila University, Quezon City, Philippines.'}, {'ForeName': 'Ma Mercedes T', 'Initials': 'MMT', 'LastName': 'Rodrigo', 'Affiliation': 'Department of Psychology, Ateneo de Manila University, Quezon City, Philippines.'}]",Games for health journal,['10.1089/g4h.2019.0091']
2901,33054533,"Optical coherence tomography outcomes from SPRINT-MS, a multicenter, randomized, double-blind trial of ibudilast in progressive multiple sclerosis.","BACKGROUND


The SPRINT-MS trial demonstrated benefit of ibudilast on brain atrophy over 96 weeks in progressive multiple sclerosis (MS). Optical coherence tomography (OCT) was performed in all trial participants.
OBJECTIVE


Report the OCT results of the SPRINT-MS trial.
METHODS


OCT was obtained at baseline and every 6 months using spectral domain OCT and analyzed by an OCT reading center. Change in each OCT outcome measure by treatment group was estimated using linear mixed models.
RESULTS


Change in pRNFL thickness was +0.0424 uM/year (95% confidence interval (CI): -0.3091 to 0.3939) for ibudilast versus -0.2630 uM (95% CI: -0.5973 to 0.0714) for placebo ( n  = 244,  p  = 0.22). Macular volume change was -0.00503 mm 3 /year (-0.02693 to 0.01688) with ibudilast versus -0.03659 mm 3 /year (-0.05824 to -0.01494) for placebo in the Spectralis cohort ( n  = 61,  p  = 0.044). For the Cirrus cohort, macular volume change was -0.00040 mm 3 /year (-0.02167, 0.020866) with ibudilast compared to -0.02083 mm 3 /year (-0.04134 to -0.00033) for placebo ( n  = 183,  p  = 0.1734). Ganglion cell-inner plexiform layer thickness change, available from Cirrus, was -0.4893 uM/year (-0.9132, -0.0654) with ibudilast versus -0.9587 uM/year (-1.3677, -0.5498) with placebo ( n  = 183,  p  = 0.12).
CONCLUSION


Retinal thinning in MS may be attenuated by ibudilast. Sample size estimates suggest OCT can be a viable outcome measure in progressive MS trials if a therapy has a large treatment effect.
TRIAL REGISTRATION


NN102/SPRINT-MS ClinicalTrials.gov number, NCT01982942.",2020,Macular volume change was -0.00503 mm 3 /year,['progressive multiple sclerosis'],"['Optical coherence tomography (OCT', 'placebo']","['Macular volume change', 'pRNFL thickness', 'Ganglion cell-inner plexiform layer thickness change']","[{'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0035316', 'cui_str': 'Retinal Ganglion Cells'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0450207', 'cui_str': 'Plexiform'}]",,0.511881,Macular volume change was -0.00503 mm 3 /year,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Bermel', 'Affiliation': 'Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Janel K', 'Initials': 'JK', 'LastName': 'Fedler', 'Affiliation': 'Data Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kaiser', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Novalis', 'Affiliation': 'Digital Angiography Reading Center, Great Neck, NY, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Schneebaum', 'Affiliation': 'Digital Angiography Reading Center, Great Neck, NY, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Klingner', 'Affiliation': 'Data Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Williams', 'Affiliation': 'Digital Angiography Reading Center, Great Neck, NY, USA.'}, {'ForeName': 'Jon W', 'Initials': 'JW', 'LastName': 'Yankey', 'Affiliation': 'Data Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Dixie J', 'Initials': 'DJ', 'LastName': 'Ecklund', 'Affiliation': 'Data Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Chase', 'Affiliation': 'Clinical Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Naismith', 'Affiliation': 'Department of Neurology, Washington University, St. Louis, MI, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Klawiter', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Goodman', 'Affiliation': 'Department of Neurology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Coffey', 'Affiliation': 'Data Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Fox', 'Affiliation': 'Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458520964409']
2902,33054556,Augmenting Frontal Dopamine Tone Enhances Maintenance over Gating Processes in Working Memory.,"The contents of working memory must be maintained in the face of distraction, but updated when appropriate. To manage these competing demands of stability and flexibility, maintained representations in working memory are complemented by distinct gating mechanisms that selectively transmit information into and out of memory stores. The operations of such dopamine-dependent gating systems in the midbrain and striatum and their complementary dopamine-dependent memory maintenance operations in the cortex may therefore be dissociable. If true, selective increases in cortical dopamine tone should preferentially enhance maintenance over gating mechanisms. To test this hypothesis, tolcapone, a catechol- O -methyltransferase inhibitor that preferentially increases cortical dopamine tone, was administered in a randomized, double-blind, placebo-controlled, within-subject fashion to 49 participants who completed a hierarchical working memory task that varied maintenance and gating demands. Tolcapone improved performance in a condition with higher maintenance requirements and reduced gating demands, reflected in a reduction in the slope of RTs across the distribution. Resting-state fMRI data demonstrated that the degree to which tolcapone improved performance in individual participants correlated with increased connectivity between a region important for first-order stimulus response mappings (left dorsal premotor cortex) and cortical areas implicated in visual working memory, including the intraparietal sulcus and fusiform gyrus. Together, these results provide evidence that augmenting cortical dopamine tone preferentially improves working memory maintenance.",2020,"Tolcapone improved performance in a condition with higher maintenance requirements and reduced gating demands, reflected in a reduction in the slope of RTs across the distribution.",['49 participants who completed a hierarchical working memory task that varied maintenance and gating demands'],"['placebo', 'Tolcapone']",['working memory maintenance'],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0246330', 'cui_str': 'tolcapone'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",49.0,0.073384,"Tolcapone improved performance in a condition with higher maintenance requirements and reduced gating demands, reflected in a reduction in the slope of RTs across the distribution.","[{'ForeName': 'Daniella J', 'Initials': 'DJ', 'LastName': 'Furman', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Zhihao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'University of California, Berkeley.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Chatham', 'Affiliation': 'F. Hoffman-La Roche AG, Basel Switzerland.'}, {'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Good', 'Affiliation': 'University of California, Berkeley.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Badre', 'Affiliation': 'Brown University.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hsu', 'Affiliation': 'University of California, Berkeley.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Kayser', 'Affiliation': 'University of California, San Francisco.'}]",Journal of cognitive neuroscience,['10.1162/jocn_a_01641']
2903,33054579,An 8 miRNA-Based Risk Score System for Predicting the Prognosis of Patients With Papillary Thyroid Cancer.,"BACKGROUND


Dysregulation of microRNAs (miRNAs) in papillary thyroid cancer (PTC) might influence prognosis of PTC. This study is aimed to develop a risk score system for predicting prognosis of PTC.
METHODS


The miRNA and gene expression profiles of PTC were obtained from The Cancer Genome Atlas database. PTC samples were randomly separated into training set (n = 248) and validation set (n = 248). The differentially expressed miRNAs (DE-miRNAs) in the training set were screened using limma package. The independent prognosis-associated DE-miRNAs were identified for building a risk score system. Risk score of PTC samples in the training set was calculated and samples were divided into high risk group and low risk group. Kaplan-Meier curves and receiver operating characteristic (ROC) curve were used to assess the accuracy of the risk score system in the training set, validation set and entire set. Finally, a miRNA-gene regulatory network was visualized by Cytoscape software, followed by enrichment analysis.
RESULTS


Totally, 162 DE-miRNAs between tumor and control groups in the training set were identified. An 8 independent prognosis-associated DE-miRNAs, (including miR-1179, miR-133b, miR-3194, miR-3912, miR-548j, miR-6720, miR-6734, and miR-6843) based risk score system was developed. The area under ROC curve in the training set, validation set and entire set was all above 0.93. A miRNA-gene regulatory network involving the 8 DE-miRNAs were built and functional enrichment analysis suggested the genes in the network were significantly enriched into 13 pathways, including calcium signaling pathway and hedgehog signaling pathway.
CONCLUSION


The risk score system developed this study might be used for predicting the prognosis of PTC. Besides, the 8 miRNAs might affect the prognosis of PTC via hedgehog signaling pathway and calcium signaling pathway.",2020,"An 8 independent prognosis-associated DE-miRNAs, (including miR-1179, miR-133b, miR-3194, miR-3912, miR-548j, miR-6720, miR-6734, and miR-6843) based risk score system was developed.","['papillary thyroid cancer (PTC', 'Patients With Papillary Thyroid Cancer']",[],"['Risk score of PTC samples', 'Kaplan-Meier curves and receiver operating characteristic (ROC) curve', 'area under ROC curve']","[{'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}]",248.0,0.0259455,"An 8 independent prognosis-associated DE-miRNAs, (including miR-1179, miR-133b, miR-3194, miR-3912, miR-548j, miR-6720, miR-6734, and miR-6843) based risk score system was developed.","[{'ForeName': 'Wanwan', 'Initials': 'W', 'LastName': 'Yi', 'Affiliation': ""Department of Nuclear Medicine, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Nuclear Medicine, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shuping', 'Initials': 'S', 'LastName': 'Qu', 'Affiliation': 'Department of Hepatic Surgery, The Eastern Hepatobiliary Surgery Hospital, Navy Medical University (Second Military Medical University), Shanghai, China.'}, {'ForeName': 'Hengwei', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Department of Hepatic Surgery, The Eastern Hepatobiliary Surgery Hospital, Navy Medical University (Second Military Medical University), Shanghai, China.'}, {'ForeName': 'Zhongwei', 'Initials': 'Z', 'LastName': 'Lv', 'Affiliation': ""Department of Nuclear Medicine, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}]",Technology in cancer research & treatment,['10.1177/1533033820965594']
2904,33054727,"Efficacy and safety of early ultrafiltration in patients with acute decompensated heart failure with volume overload: a prospective, randomized, controlled clinical trial.","BACKGROUND


Ultrafiltration decreases total body water and improves the alveolar to arterial oxygen gradient. The aims of the study were to investigate the efficacy and safety of early ultrafiltration in acute decompensated heart failure (ADHF) patients.
METHODS


100 patients with ADHF within 24 h of admission were randomly assigned into early ultrafiltration (n = 40) or torasemide plus tolvaptan (n = 60) groups. The primary outcomes were weight loss and an increase in urine output on days 4 and 8 of treatment.
RESULTS


Patients who received early ultrafiltration for 3 days achieved a greater weight loss (kg) (- 2.94 ± 3.76 vs - 0.64 ± 0.91, P < 0.001) and urine increase (mL) (198.00 ± 170.70 vs 61.77 ± 4.67, P < 0.001) than the torasemide plus tolvaptan group on day 4. From days 4 to 7, patients in the early ultrafiltration group received sequential therapy of torasemide and tolvaptan. Better control of volume was reflected in a greater weight loss (- 3.72 ± 3.81 vs - 1.34 ± 1.32, P < 0.001) and urine increase (373.80 ± 120.90 vs 79.5 ± 52.35, P < 0.001), greater reduction of B-type natriuretic peptide (BNP) (pg/mL) (- 1144 ± 1435 vs - 654.02 ± 889.65, P = 0.037), NYHA (New York Heart Association) functional class (- 1.45 ± 0.50 vs - 1.17 ± 0.62, P = 0.018), jugular venous pulse (JVP) score (points) (- 1.9 ± 1.13 vs - 0.78 ± 0.69, P < 0.001), inferior vena cava (IVC) diameter (mm) (- 15.35 ± 11.03 vs - 4.98 ± 6.00, P < 0.001) and an increase in the dyspnea score (points) (4.08 ± 3.44 vs 2.77 ± 2.03, P = 0.035) in the early ultrafiltration group on day 8. No significant differences were found in the readmission and mortality rates in the 2 patient groups at the 1-month and 3-month follow-ups. Both groups had a similar stable renal profile.
CONCLUSION


Early ultrafiltration is superior to diuretics for volume overload treatment initiation of ADHF patients. Trial registration Chinese Clinical Trial Registry, ChiCTR2000030696, Registered 10 March 2020-Retrospectively registered, https://www.chictr.org.cn/showproj.aspx?proj=29099 .",2020,No significant differences were found in the readmission and mortality rates in the 2 patient groups at the 1-month and 3-month follow-ups.,"['100 patients with ADHF within 24\xa0h of admission', 'acute decompensated heart failure (ADHF) patients', 'ADHF patients', 'patients with acute decompensated heart failure with volume overload']","['torasemide plus tolvaptan', 'sequential therapy of torasemide and tolvaptan', 'early ultrafiltration']","['weight loss', 'weight loss and an increase in urine output on days 4 and 8 of treatment', 'readmission and mortality rates', 'efficacy and safety', 'jugular venous pulse (JVP) score (points', 'stable renal profile', 'Efficacy and safety', 'greater weight loss', 'urine increase', 'inferior vena cava (IVC) diameter', 'reduction of B-type natriuretic peptide (BNP) (pg/mL', 'dyspnea score']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia'}]","[{'cui': 'C0076840', 'cui_str': 'torsemide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0232133', 'cui_str': 'Jugular venous pulse'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0278356', 'cui_str': 'Kidney panel'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0042458', 'cui_str': 'Inferior vena cava structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]",100.0,0.164777,No significant differences were found in the readmission and mortality rates in the 2 patient groups at the 1-month and 3-month follow-ups.,"[{'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Critical Care Medicine (Specialty of Heart Failure), Tongren Hospital, Shanghai Jiaotong University School of Medicine, No. 1111 Xianxia Road, Shanghai, 200336, China.'}, {'ForeName': 'Qianli', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': 'Department of Critical Care Medicine (Specialty of Heart Failure), Tongren Hospital, Shanghai Jiaotong University School of Medicine, No. 1111 Xianxia Road, Shanghai, 200336, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Critical Care Medicine (Specialty of Heart Failure), Tongren Hospital, Shanghai Jiaotong University School of Medicine, No. 1111 Xianxia Road, Shanghai, 200336, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, Tongren Hospital, Shanghai Jiaotong University School of Medicine, No. 1111 Xianxia Road, Shanghai, 200336, China.'}, {'ForeName': 'Miaomiao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine (Specialty of Heart Failure), Tongren Hospital, Shanghai Jiaotong University School of Medicine, No. 1111 Xianxia Road, Shanghai, 200336, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Tongren Hospital, Shanghai Jiaotong University School of Medicine, No. 1111 Xianxia Road, Shanghai, 200336, China. jiangli@shtrhospital.com.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yuan', 'Affiliation': 'Department of Critical Care Medicine (Specialty of Heart Failure), Tongren Hospital, Shanghai Jiaotong University School of Medicine, No. 1111 Xianxia Road, Shanghai, 200336, China. yfangBM@163.com.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01733-5']
2905,33054737,Schema therapy versus cognitive behavioral therapy versus individual supportive therapy for depression in an inpatient and day clinic setting: study protocol of the OPTIMA-RCT.,"BACKGROUND


Major depressive disorder represents (MDD) a major cause of disability and disease burden. Beside antidepressant medication, psychotherapy is a key approach of treatment. Schema therapy has been shown to be effective in the treatment of psychiatric disorders, especially personality disorders, in a variety of settings and patient groups. Nevertheless, there is no evidence on its effectiveness for MDD in an inpatient nor day clinic setting and little is known about the factors that drive treatment response in such a target group.
METHODS


In the current protocol, we outline OPTIMA (OPtimized Treatment Identification at the MAx Planck Institute): a single-center randomized controlled trial of schema therapy as a treatment approach for MDD in an inpatient and day clinic setting. Over the course of 7 weeks, we compare schema therapy with cognitive behavioral therapy and individual supportive therapy, conducted in individual and group sessions and with no restrictions regarding concurrent antidepressant medication, thus approximating real-life treatment conditions. N = 300 depressed patients are included. All study therapists undergo a specific training and supervision and therapy adherence is assessed. Primary outcome is depressive symptom severity as self-assessment (Beck Depression Inventory-II) and secondary outcomes are clinical ratings of MDD (Montgomery-Asberg Depression Rating Scale), recovery rates after 7 weeks according to the Munich-Composite International Diagnostic Interview, general psychopathology (Brief Symptom Inventory), global functioning (World Health Organization Disability Assessment Schedule), and clinical parameters such as dropout rates. Further parameters on a behavioral, cognitive, psychophysiological, and biological level are measured before, during and after treatment and in 2 follow-up assessments after 6 and 24 months after end of treatment.
DISCUSSION


To our knowledge, the OPTIMA-Trial is the first to investigate the effectiveness of schema therapy as a treatment approach of MDD, to investigate mechanisms of change, and explore predictors of treatment response in an inpatient and day clinic setting by using such a wide range of parameters. Insights from OPTIMA will allow more integrative approaches of psychotherapy of MDD. Especially, the identification of intervention-specific markers of treatment response can improve evidence-based clinical decision for individualizing treatment.
TRIAL REGISTRATION


Identifier on clinicaltrials.gov : NCT03287362 ; September, 12, 2017.",2020,"Schema therapy has been shown to be effective in the treatment of psychiatric disorders, especially personality disorders, in a variety of settings and patient groups.",['N\u2009=\u2009300 depressed patients are included'],"['cognitive behavioral therapy and individual supportive therapy, conducted in individual and group sessions and with no restrictions regarding concurrent antidepressant medication', 'Schema therapy versus cognitive behavioral therapy versus individual supportive therapy']","['behavioral, cognitive, psychophysiological, and biological level', 'depressive symptom severity as self-assessment (Beck Depression Inventory-II) and secondary outcomes are clinical ratings of MDD (Montgomery-Asberg Depression Rating Scale), recovery rates after 7 weeks according to the Munich-Composite International Diagnostic Interview, general psychopathology (Brief Symptom Inventory), global functioning (World Health Organization Disability Assessment Schedule), and clinical parameters such as dropout rates']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C5200813', 'cui_str': 'Schema Therapy'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0451085', 'cui_str': 'Composite international diagnostic interview'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0451124', 'cui_str': 'Disability assessment schedule'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",300.0,0.0259604,"Schema therapy has been shown to be effective in the treatment of psychiatric disorders, especially personality disorders, in a variety of settings and patient groups.","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kopf-Beck', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany. kopf-beck@psych.mpg.de.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Zimmermann', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Samy', 'Initials': 'S', 'LastName': 'Egli', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rein', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Kappelmann', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Fietz', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Tamm', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Rek', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Lucae', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Anna-Katharine', 'Initials': 'AK', 'LastName': 'Brem', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Sämann', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Leonhard', 'Initials': 'L', 'LastName': 'Schilbach', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Martin E', 'Initials': 'ME', 'LastName': 'Keck', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}]",BMC psychiatry,['10.1186/s12888-020-02880-x']
2906,33054742,Impact evaluation of scripted lesson plans for HIV-related content in a life orientation curriculum: results from two provinces in South Africa.,"BACKGROUND


Young people under age 25 years are a key population at risk of unintended pregnancies, HIV and other sexually transmitted infections. School-based programming, focusing on youth under 17 years is strategic given that many in this age group are in school or are required to be in school and spend a considerable amount of their time at school. Prior evaluations of school-based HIV prevention programs for young people often employed weak study designs or lacked biomarkers (e.g., HIV or STI testing) to inform outcomes.
METHODS


This study used longitudinal data collected in 2016 from a cohort of grade-8 girls from Mpumalanga and KwaZulu-Natal Provinces in South Africa. We followed them for 2 years to examine the impact of the South African Department of Basic Education's revised scripted lesson plans for the HIV and sexual content of a ""life orientation"" curriculum on knowledge, attitudes, condom use behaviors, pregnancy incidence, and genital herpes incidence. Schools were randomized to intervention and control arms. Multivariable analyses were undertaken using hazard modeling for incidence-based outcomes (genital herpes and pregnancy) and generalized linear latent and mixed modeling for outcomes measured at each time period (knowledge, attitudes, and condom use).
RESULTS


At end line, 105 schools were included from the two provinces (44 from Mpumalanga and 61 from KwaZulu-Natal). Fifty-five were intervention and fifty were control schools. A total of 2802 girls were surveyed at both time periods (1477 intervention and 1325 control). At baseline, participating girls were about 13.6 years; by end line, they were about 2 years older. Longitudinal data demonstrated few differences between intervention and control groups on knowledge, attitudes, condom use, genital herpes, and pregnancy experience. Monitoring data demonstrated that the program was not implemented as intended. Our results demonstrated 7% incidence of genital herpes in the two-year follow-up period indicating sexual risk-taking among our cohort.
CONCLUSIONS


We did not find significant effects of the revised life orientation curriculum on key outcomes; however, this may reflect poor implementation. Future HIV prevention programs for young people need to be implemented with fidelity to ensure they meet the crucial needs of the next generation.
TRIAL REGISTRATION


This study has been registered at ClinicalTrials.gov . The trial registration number is: NCT04205721 . The trial was retrospectively registered on December 18, 2019.",2020,"Longitudinal data demonstrated few differences between intervention and control groups on knowledge, attitudes, condom use, genital herpes, and pregnancy experience.","['2016 from a cohort of grade-8 girls from Mpumalanga and KwaZulu-Natal Provinces in South Africa', 'two provinces in South Africa', 'Young people under age 25\u2009years', '2802 girls were surveyed at both time periods (1477 intervention and 1325 control', 'Fifty-five were intervention and fifty were control schools', '105 schools were included from the two provinces (44 from Mpumalanga and 61 from KwaZulu-Natal']","['school-based HIV prevention programs', 'scripted lesson plans']","['knowledge, attitudes, condom use behaviors, pregnancy incidence, and genital herpes incidence', 'genital herpes', 'knowledge, attitudes, condom use, genital herpes, and pregnancy experience']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019342', 'cui_str': 'Genital herpes simplex'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",2802.0,0.0517119,"Longitudinal data demonstrated few differences between intervention and control groups on knowledge, attitudes, condom use, genital herpes, and pregnancy experience.","[{'ForeName': 'Ilene S', 'Initials': 'IS', 'LastName': 'Speizer', 'Affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill, 123 W. Franklin St., Chapel Hill, NC, 27516, USA. speizer@email.unc.edu.'}, {'ForeName': 'Mahua', 'Initials': 'M', 'LastName': 'Mandal', 'Affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill, 123 W. Franklin St., Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Khou', 'Initials': 'K', 'LastName': 'Xiong', 'Affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill, 123 W. Franklin St., Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Ndinda', 'Initials': 'N', 'LastName': 'Makina', 'Affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill, 123 W. Franklin St., Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Hattori', 'Affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill, 123 W. Franklin St., Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Darryn', 'Initials': 'D', 'LastName': 'Durno', 'Affiliation': 'SADC Research Centre, Cape Town, South Africa, USA.'}]",BMC public health,['10.1186/s12889-020-09640-2']
2907,33054780,Flexible versus standard intramedullary rod in posterior stabilized primary total knee arthroplasty: protocol for a randomized controlled trial.,"BACKGROUND


In total knee arthroplasty (TKA) a flexible intramedullary rod can be used to account for sagittal bowing of the distal femur. Although patients report better post-operative functional outcome when the flexible rod was used, it is unknown how the use of the flexible rod affects the placement of the femoral TKA component, and how this relates to activities of daily living. It is expected that the use of the flexible rod will result in a more flexed femoral component, a larger patellar tendon moment arm, and consequently in better functional outcome. The goal of this study is to compare the flexible rod to the standard intramedullary rod in primary TKA in terms of fit of the TKA, functional outcome, and sizing of the femoral component.
METHODS


A single-blind randomized controlled trial with two groups (flexible vs standard rod), with patients blinded for group allocation, and 2 years post-operative follow-up. The fit of the TKA is quantified by two parameters: (1) the flexion angle of the TKA in the sagittal plane and (2) the sagittal profile of the distal femur compared between the pre-operative bone and the TKA. Both parameters are calculated in 3D volume images obtained using fluoroscopy. Functional outcome will be measured using (1) the timed Get-up and Go test (2), the stair climbing test (3), knee power output, and (4) patient and clinician reported outcomes. Different parameters will be measured during the TKA procedure to account for the invisibility of cartilage in the 3D volumes and to study if the amount of bone removed during the procedure is affected by group allocation.
DISCUSSION


The sagittal fit of TKA is not a standardized outcome measure. We discuss our choice of parameters to define the sagittal fit (i.e., flexion angle and sagittal profile), our choice for the parameters we measure during the TKA procedure to account for the lack of cartilage thickness in fluoroscopy, and our choice for the parameters to study if the amount of bone removed during the procedure is affected by group allocation. Lastly, we discuss the merits of this planned trial.
TRIAL REGISTRATION


Netherlands Trial Register, 4888 , registered 30 March 2015. https://www.trialregister.nl/trial/4888.",2020,In total knee arthroplasty (TKA) a flexible intramedullary rod can be used to account for sagittal bowing of the distal femur.,['posterior stabilized primary total knee arthroplasty'],"['total knee arthroplasty (TKA', 'Flexible versus standard intramedullary rod']",[],"[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0336581', 'cui_str': 'Intramedullary rod'}]",[],,0.0810919,In total knee arthroplasty (TKA) a flexible intramedullary rod can be used to account for sagittal bowing of the distal femur.,"[{'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Bénard', 'Affiliation': 'Sint Maartenskliniek Research, Sint Maartenskliniek, Nijmegen, The Netherlands.'}, {'ForeName': 'R F M', 'Initials': 'RFM', 'LastName': 'van Doremalen', 'Affiliation': 'Robotics and Mechatronics, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Wymenga', 'Affiliation': 'Sint Maartenskliniek Orthopaedics, Sint Maartenskliniek, Nijmegen, The Netherlands.'}, {'ForeName': 'P J C', 'Initials': 'PJC', 'LastName': 'Heesterbeek', 'Affiliation': 'Sint Maartenskliniek Research, Sint Maartenskliniek, Nijmegen, The Netherlands. p.heesterbeek@maartenskliniek.nl.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01989-9']
2908,33054984,"Comprehension of confidence intervals in audio-visual patient information materials for people with multiple sclerosis (COCO-MS): A web-based randomised controlled, parallel group trial.","OBJECTIVES


To evaluate patient information materials on confidence intervals (CIs) in multiple sclerosis to be used with patient decision aids.
METHODS


Web-based randomised controlled parallel group trial with four study arms. Participants were equally allocated to one of three versions of audio-visual patient information or to a standard written information (arm IV). In the short version (arm III), CIs were explained without using an example, in the other two versions examples were used (arm I and arm II). The examples are based on an apple farmer who wants to estimate the average weight of his apples (arm I) and to test a treatment against worms (arm II). Primary endpoint was comprehension of CIs, assessed with a six-item multiple-choice questionnaire.
RESULTS


855 of 1068 (80 %) randomised participants completed the survey (71 % arm I, 73 % arm II, 87 % arm III, 90 % arm IV). The median of correctly answered questions on CIs was 4 out of 6 questions in arms I and II and 5 out of 6 questions in arm III. Compared to the standard information (arm IV), all the other arms scored better on the comprehension questionnaire (ANOVA, p ≤ 0.003).
CONCLUSIONS


Information about CIs can be presented comprehensibly. High scores and a high rate of completers indicate that the short version is the favourable one.
PRACTICE IMPLICATIONS


Information materials on CIs should be used alongside absolute risk reductions in patient decision aids to enhance the interpretation of study results.",2020,"Compared to the standard information (arm IV), all the other arms scored better on the comprehension questionnaire (ANOVA, p ≤ 0.003).
","['855 of 1068 (80 %) randomised participants completed the survey (71 % arm', 'people with multiple sclerosis (COCO-MS']",[],"['comprehension of CIs, assessed with a six-item multiple-choice questionnaire']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0009211', 'cui_str': 'Cocos'}]",[],"[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0848201,"Compared to the standard information (arm IV), all the other arms scored better on the comprehension questionnaire (ANOVA, p ≤ 0.003).
","[{'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Rahn', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Health Services Research, Carl von Ossietzky University Oldenburg, Oldenburg, Germany. Electronic address: anne.christin.rahn@uni-oldenburg.de.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Riemann-Lorenz', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Alegiani', 'Affiliation': 'Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Gesa E A', 'Initials': 'GEA', 'LastName': 'Pust', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Adrianus', 'Initials': 'A', 'LastName': 'van de Roemer', 'Affiliation': 'Institut für Didaktik in der Medizin, Michelstadt, Germany.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Schmitz', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Eik', 'Initials': 'E', 'LastName': 'Vettorazzi', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Köpke', 'Affiliation': 'Institute of Nursing Science, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Heesen', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Patient education and counseling,['10.1016/j.pec.2020.09.035']
2909,33055007,Prognostic value of the early change in neutrophil-to-lymphocyte ratio in metastatic pancreatic adenocarcinoma.,"In metastatic pancreatic adenocarcinoma, a high neutrophil-to-lymphocyte ratio (NLR) at diagnosis is a marker of poor prognosis. The prognostic role of baseline NLR and NLR change during first-line chemotherapy were determined. We conducted a retrospective study by using data from a single-center prospective cohort and a randomized open-label, multicenter, randomized trial. Two hundred and twelve patients were analyzed. Baseline NLR > 5 was an independent marker of poor prognosis for overall survival (HR = 2.01, 95% CI 1.33-3.05; P = 0.001) and progression-free survival (PFS; HR=1.80, 95% CI 1.23-2.65; P = 0.0026). According to NLR dynamics (n = 172), patients with NLR ≤ 5 on days 1 and 15 had a significantly better prognosis than those with NLR ≤ 5 on day 1 and NLR > 5 on day 15 (HR = 2.23, 95% CI 1.18-4.21; P = 0.013), NLR >5 on day 1 and NLR ≤5 on day 15 (HR=3.25, 95% CI 1.86-5.68; P < 0.001), and NLR >5 on days 1 and 15 (HR=3.37, 95% CI 1.93-5.90; P < 0.001). Over time, bad responders (PFS <6 months) had significantly higher mean NLR than good responders (PFS >6 months; group effect: P < 0.0001). Seven out of eight patients with baseline NLR >5 had circulating tumor DNA. This study confirmed the independent prognostic value of baseline NLR >5 in metastatic pancreatic cancer. The change in NLR early during chemotherapy was also a prognostic indicator in patients with NLR ≤5.",2020,"Baseline NLR > 5 was an independent marker of poor prognosis for overall survival (HR = 2.01, 95% CI 1.33-3.05; P = 0.001) and progression-free survival (PFS; HR=1.80","['Two hundred and twelve patients were analyzed', 'metastatic pancreatic cancer', 'metastatic pancreatic adenocarcinoma', 'patients with NLR ≤5']",[],"['progression-free survival', 'circulating tumor DNA', 'overall survival']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}, {'cui': 'C0861727', 'cui_str': 'Pancreatic adenocarcinoma metastatic'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",[],"[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",212.0,0.0623205,"Baseline NLR > 5 was an independent marker of poor prognosis for overall survival (HR = 2.01, 95% CI 1.33-3.05; P = 0.001) and progression-free survival (PFS; HR=1.80","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McLellan', 'Affiliation': ""Sorbonne Université, 4 Place Jussieu, 75005, Paris, France; Department of Hepato-Gastroenterology, Hôpital Pitié-Salpêtrière, 47 Boulevard de l'Hôpital 75013, APHP, Paris, France.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Henriques', 'Affiliation': 'Department of Methodology and Quality of Life Oncology, University Hospital, 3 Boulevard Alexandre Fleming, 25000 Besancon, France; Bourgogne Franche-Comté Université, INSERM, EFS BFC, UMR1098, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, 8 rue du Docteur Jean-François-Xavier Girod, 25020 Besançon, France.'}, {'ForeName': 'Feryel', 'Initials': 'F', 'LastName': 'Ksontini', 'Affiliation': 'Department of Oncology, Institute Salah-Azaïz, Boulevard du 9 avril 1938, 1006 Tunis, Tunisia.'}, {'ForeName': 'Solène', 'Initials': 'S', 'LastName': 'Doat', 'Affiliation': ""Department of Hepato-Gastroenterology, Hôpital Pitié-Salpêtrière, 47 Boulevard de l'Hôpital 75013, APHP, Paris, France.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Department of Digestive Oncology, Hôpital Beaujon, 100 Boulevard du General Leclerc, 92110 Clichy, France.'}, {'ForeName': 'Jérome', 'Initials': 'J', 'LastName': 'Desrame', 'Affiliation': 'Department of Gastroenterology, Hôpital Privé Jean Mermoz, 55 avenue Jean Mermoz, 69008 Lyon, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Trouilloud', 'Affiliation': 'Department of Oncology, Hôpital Saint-Antoine, 186 rue du Faubourg Saint Antoine, 75012 Paris, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Louvet', 'Affiliation': 'Department of Oncology, Institut Mutualiste Montsouris, 54 avenue Jourdan, 75014 Paris, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pietrasz', 'Affiliation': 'Department of Hepato-Pancreato-Biliary Surgery, CHB, Hôpital Paul Brousse, 12 Avenue Paul Vaillant Couturier, 94800 Villejuif, France.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Vernerey', 'Affiliation': 'Department of Methodology and Quality of Life Oncology, University Hospital, 3 Boulevard Alexandre Fleming, 25000 Besancon, France; Bourgogne Franche-Comté Université, INSERM, EFS BFC, UMR1098, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, 8 rue du Docteur Jean-François-Xavier Girod, 25020 Besançon, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': ""Sorbonne Université, 4 Place Jussieu, 75005, Paris, France; Department of Hepato-Gastroenterology, Hôpital Pitié-Salpêtrière, 47 Boulevard de l'Hôpital 75013, APHP, Paris, France. Electronic address: jean-baptiste.bachet@aphp.fr.""}]",Clinics and research in hepatology and gastroenterology,['10.1016/j.clinre.2020.08.016']
2910,33055009,Effects of a health education program to promote healthy lifestyle and glycemic control in patients with type 2 diabetes: A randomized controlled trial.,"BACKGROUND


Type 2 diabetes mellitus (T2DM) is a common chronic disease with an increase in prevalence within developing countries. The aim of this study was to determine the efficacy of a structured educational program for improving lifestyle and health-related measures in Iranians with T2DM.
METHODS


A randomized controlled trial was conducted in 80 participants with T2DM who were randomly assigned to either the intervention or a control group. A demographic questionnaire along with the Health Promoting Lifestyle Profile-II and related laboratory tests were used to assess the efficacy of the program. The intervention consisted of six educational sessions held over 45 days. The control group received routine diabetic care at the clinic. Three months after the intervention, participants completed the measures again. Within-group and between-group comparisons were then made.
RESULTS


All subscales of lifestyle measure improved in the intervention group, whereas only the nutrition domain improved in the control group. After adjusting for baseline differences, physical activity and nutrition domains showed the greatest improvement in the intervention group compared to controls. All clinical measures were also significantly improved within intervention group from baseline to follow-up (p < 0.001), whereas HbA1c, fasting blood glucose, HDL, triglyceride, cholesterol, and weight also changed significantly in the control group. The frequency of HbA1c < 7% was increased from 27.5% at baseline to 37.5% at follow-up (10%) in the intervention group compared to only a 5% increase in the control group.
CONCLUSION


This educational health program significantly improved lifestyle changes and health-related clinical characteristics in persons with T2DM, compared to routine diabetic care in Iran. Further research is needed to better understand the usefulness of such programs in diabetics and other medical conditions among those in different cultural settings.",2020,"All clinical measures were also significantly improved within intervention group from baseline to follow-up (p < 0.001), whereas HbA1c, fasting blood glucose, HDL, triglyceride, cholesterol, and weight also changed significantly in the control group.","['80 participants with T2DM', 'patients with type 2 diabetes', 'persons with T2DM, compared to routine diabetic care in Iran', 'Iranians with T2DM']","['structured educational program', 'routine diabetic care', 'health education program']","['frequency of HbA1c', 'HbA1c, fasting blood glucose, HDL, triglyceride, cholesterol, and weight', 'healthy lifestyle and glycemic control', 'physical activity and nutrition domains', 'nutrition domain']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0150544', 'cui_str': 'Diabetic care'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0150544', 'cui_str': 'Diabetic care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",80.0,0.048797,"All clinical measures were also significantly improved within intervention group from baseline to follow-up (p < 0.001), whereas HbA1c, fasting blood glucose, HDL, triglyceride, cholesterol, and weight also changed significantly in the control group.","[{'ForeName': 'Hormoz', 'Initials': 'H', 'LastName': 'Sanaeinasab', 'Affiliation': 'Health Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran; Health Education Department, Faculty of Health, Baqiyatallah University of Medical Sciences, Tehran, Iran. Electronic address: sanaei1343@gmail.com.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Saffari', 'Affiliation': 'Health Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran; Health Education Department, Faculty of Health, Baqiyatallah University of Medical Sciences, Tehran, Iran. Electronic address: m.saffari@bmsu.ac.ir.'}, {'ForeName': 'Davoud', 'Initials': 'D', 'LastName': 'Yazdanparast', 'Affiliation': 'Health Education Department, Faculty of Health, Baqiyatallah University of Medical Sciences, Tehran, Iran. Electronic address: hjch1400@gmail.com.'}, {'ForeName': 'Aliakbar', 'Initials': 'A', 'LastName': 'Karimi Zarchi', 'Affiliation': 'Health Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran; Department of Epidemiology and Biostatistics, Baqiyatallah University of Medical Sciences, Tehran, Iran. Electronic address: alikarimi_in@yahoo.com.'}, {'ForeName': 'Faten', 'Initials': 'F', 'LastName': 'Al-Zaben', 'Affiliation': 'Division of Psychiatry, Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia. Electronic address: faten_zaben@yahoo.com.'}, {'ForeName': 'Harold G', 'Initials': 'HG', 'LastName': 'Koenig', 'Affiliation': 'Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA; Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia; School of Public Health, Ningxia Medical University, Yinchuan, China. Electronic address: Harold.Koenig@duke.edu.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Pakpour', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran; Department of Nursing, School of Health and Welfare, Jönköping University, Jönköping, Sweden. Electronic address: Pakpour_Amir@yahoo.com.'}]",Primary care diabetes,['10.1016/j.pcd.2020.09.007']
2911,33055072,Exploring the Effects of a Brief Biofeedback Breathing Session Delivered Through the BioBase App in Facilitating Employee Stress Recovery: Randomized Experimental Study.,"BACKGROUND


Recovery from stress is a predictive factor for cardiovascular health, and heart rate variability (HRV) is suggested to be an index of how well people physiologically recover from stress. Biofeedback and mindfulness interventions that include guided breathing have been shown to be effective in increasing HRV and facilitating stress recovery.
OBJECTIVE


This study aims to assess the effectiveness of a brief app-based breathing intervention (BioBase) in enhancing physiological recovery among employees who were induced to cognitive and emotional stress.
METHODS


In total, we recruited 75 full-time employees. Interbeat (RR) intervals were recorded continuously for 5 min at baseline and during cognitive and emotional stress induction. The session ended with a 5-min recovery period during which participants were randomly allocated into 3 conditions: app-based breathing (BioBase), mindfulness body scan, or control. Subjective tension was assessed at the end of each period.
RESULTS


Subjective tension significantly increased following stress induction. HRV significantly decreased following the stress period. In the recovery phase, the root mean square of successive RR interval differences (P=.002), the percentage of successive RR intervals that differed by >50 ms (P=.008), and high frequency (P=.01) were significantly higher in the BioBase breathing condition than in the mindfulness body scan and the control groups.
CONCLUSIONS


Biofeedback breathing interventions digitally delivered through a commercially available app can be effective in facilitating stress recovery among employees. These findings contribute to the mobile health literature on the beneficial effects of brief app-based breathing interventions on employees' cardiovascular health.",2020,"In the recovery phase, the root mean square of successive RR interval differences (P=.002), the percentage of successive RR intervals that differed by >50 ms (P=.008), and high frequency (P=.01) were significantly higher in the BioBase breathing condition than in the mindfulness body scan and the control groups.
","['Facilitating Employee Stress Recovery', 'employees who were induced to cognitive and emotional stress']","['3 conditions: app-based breathing (BioBase), mindfulness body scan, or control', 'Biofeedback and mindfulness interventions', 'brief app-based breathing intervention (BioBase', 'Brief Biofeedback Breathing Session']","['root mean square of successive RR interval differences', 'HRV', 'Subjective tension', 'percentage of successive RR intervals', 'Interbeat (RR) intervals']","[{'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0086209', 'cui_str': 'Emotional stress'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",75.0,0.0320185,"In the recovery phase, the root mean square of successive RR interval differences (P=.002), the percentage of successive RR intervals that differed by >50 ms (P=.008), and high frequency (P=.01) were significantly higher in the BioBase breathing condition than in the mindfulness body scan and the control groups.
","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Chelidoni', 'Affiliation': 'Evolution, Behaviour and Environment, School of Life Sciences, University of Sussex, Brighton, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Plans', 'Affiliation': 'Initiative in the Digital Economy, Department of Science, Innovation, Technology, and Entrepreneurship, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Ponzo', 'Affiliation': 'BioBeats Group Ltd, London, United Kingdom.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Morelli', 'Affiliation': 'BioBeats Group Ltd, London, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cropley', 'Affiliation': 'Faculty of Health and Medical Sciences, School of Psychology, University of Surrey, Guildford, United Kingdom.'}]",JMIR mHealth and uHealth,['10.2196/19412']
2912,33054842,"Effect of probiotics on nasal and intestinal microbiota in people with high exposure to particulate matter ≤ 2.5 μm (PM2.5): a randomized, double-blind, placebo-controlled clinical study.","BACKGROUND


Extended exposure to high concentrations of PM2.5 changes the human microbiota profile, which in turn may increase morbidity and mortality due to respiratory system damage. A balanced microecosystem is crucial to human health, and certain health-related problems may be addressed by effective microecosystem regulation. Recent studies have confirmed that probiotics may reduce the incidence of respiratory diseases. However, few studies have investigated probiotic treatment outcomes in subjects exposed to high concentrations of PM2.5.
METHODS


This study is designed as a prospective, randomized, participants- and assessor-blinded, placebo-controlled trial. One hundred and twenty eligible volunteers recruited from October 2019 to July 2020 in downtown Chengdu, China, will be treated with either probiotics or placebo over 4 consecutive weeks. The primary outcome will be 16SrRNA sequencing assay data from nasal and intestinal secretions. Secondary outcomes will be pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life. Results will be analyzed to assess differences in clinical efficacy between groups. Six-month follow-up examinations will evaluate the long-term value of probiotics on cardiovascular and respiratory disease end-point events.
DISCUSSION


We will explore the characteristics of nasal and intestinal microbiota in a population with high exposure to PM2.5. Probiotics and placebo interventions will be tested for efficacy in microbial balance regulation, effects on lung and physical functions, and quality of life improvement. This study is expected to provide reliable evidence to support the widespread promotion of probiotics in clinical practice for the protection of individuals with high exposure to PM2.5.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR1900025469 . Registered on 27 August 2019.",2020,"Secondary outcomes will be pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life.","['One hundred and twenty eligible volunteers recruited from October 2019 to July 2020 in downtown Chengdu, China, will be treated with either', 'people with high exposure to particulate matter ≤\u20092.5\u2009μm (PM2.5', 'individuals with high exposure to PM2.5', 'population with high exposure to PM2.5']","['Probiotics and placebo interventions', 'placebo', 'probiotics', 'probiotics or placebo']","['clinical efficacy', 'pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life', 'lung and physical functions, and quality of life improvement', '16SrRNA sequencing assay data from nasal and intestinal secretions', 'nasal and intestinal microbiota']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0021849', 'cui_str': 'Intestinal Secretions'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",120.0,0.331946,"Secondary outcomes will be pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life.","[{'ForeName': 'Yongcan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Caixia', 'Initials': 'C', 'LastName': 'Pei', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Mingjie', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Demei', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Zhenxing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China. wangzhenxing@vip.tom.com.""}]",Trials,['10.1186/s13063-020-04759-4']
2913,33054882,Challenges and solutions to nicotine replacement therapy access: observations from SCIMITAR.,"BACKGROUND


Given that smoking results in poor physical and mental health, reducing tobacco harm is of high importance. Recommendations published by the National Institute for Health and Care Excellence to reduce smoking harms included provision of support, use of nicotine containing products and commissioning of smoking cessation services.
AIMS


This report explores the difficulties in obtaining such support, as observed in a recently conducted randomised controlled trial in patients with severe mental ill health, and outlines suggestions to improve facilitation of provision.
METHOD


Data collected during the Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR+) (trial Registration ISRCTN72955454), was reviewed to identify the difficulties experienced, across the trial, with regards to access and provision of nicotine replacements therapy (NRT). Actions taken to facilitate access and provision of NRT were collated to outline how provision could be better facilitated.
RESULTS


Access to NRT varied across study settings and in some instances proved impossible for patients to access. Difficulty in access was irrespective of a diagnosis of severe mental ill health. Where NRT was provided, this was not always provided in accordance with NICE guidelines.
CONCLUSIONS


Availability of smoking cessation support, and NRT provision would benefit from being made clearer, simpler and more easily accessible so as to enhance smoking cessation rates.",2020,"METHOD


Data collected during the Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR+) (trial Registration ISRCTN72955454), was reviewed to identify the difficulties experienced, across the trial, with regards to access and provision of nicotine replacements therapy (NRT).","['patients with severe mental ill health', 'Data collected during the Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR']","['NRT', 'nicotine replacements therapy (NRT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]",[],,0.0597588,"METHOD


Data collected during the Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR+) (trial Registration ISRCTN72955454), was reviewed to identify the difficulties experienced, across the trial, with regards to access and provision of nicotine replacements therapy (NRT).","[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Arundel', 'Affiliation': 'Department of Health Sciences, University of York, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Peckham', 'Affiliation': 'Department of Health Sciences, University of York, UK.'}, {'ForeName': 'Della', 'Initials': 'D', 'LastName': 'Bailey', 'Affiliation': 'Department of Health Sciences, University of York, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Crosland', 'Affiliation': 'Department of Health Sciences, University of York, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Heron', 'Affiliation': 'Department of Health Sciences, University of York, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, University of York, UK.'}]",BJPsych open,['10.1192/bjo.2020.100']
2914,33054890,"Consumption of multiple micronutrients or small-quantity lipid-based nutrient supplements containing iodine at the recommended dose during pregnancy, compared with iron and folic acid, does not affect women's urinary iodine concentration in rural Malawi: a secondary outcome analysis of the iLiNS DYAD trial.","OBJECTIVES


Inadequate iodine intake during pregnancy increases the risk of neonatal morbidity and mortality. We aimed to evaluate whether prenatal supplements containing iodine affect urinary iodine concentrations (UIC) of pregnant women in Malawi.
DESIGN


A randomised controlled trial. Pregnant women (n 1391) were assigned to consume 60 mg/d Fe and 400 µg/d folic acid (IFA) or 18 vitamins and minerals including 250 µg/d iodine (MMN) or 20 g/d small-quantity lipid-based nutrient supplements (SQ-LNS) with similar nutrient contents as MMN group, plus macronutrients (LNS) until childbirth. In a sub-study (n 317), we evaluated group geometric mean urinary iodine concentration (UIC) (µg/L) at 36 weeks of gestation controlling for baseline UIC and compared median (baseline) and geometric mean (36 weeks) UIC with WHO cut-offs: UIC < 150, 150-249, 250-499 and ≥500 reflecting insufficient, adequate, above requirements and excessive iodine intakes, respectively.
SETTING


Mangochi District, Malawi.
PARTICIPANTS


Women ≤20 weeks pregnant.
RESULTS


Groups had comparable background characteristics. At baseline, overall median (Q1, Q3) UIC (319 (167, 559)) suggested iodine intakes above requirements. At 36 weeks, the geometric mean (95 % CI) UIC of the IFA (197 (171, 226)), MMN (212 (185, 243)) and LNS (220 (192, 253)) groups did not differ (P = 0·53) and reflected adequate intakes.
CONCLUSIONS


In this setting, provision of supplements containing iodine at the recommended dose to pregnant women with relatively high iodine intakes at baseline, presumably from iodised salt, has no impact on the women's UIC. Regular monitoring of the iodine status of pregnant women in such settings is advisable. Clinicaltrials.gov identifier: NCT01239693.",2020,"We aimed to evaluate whether prenatal supplements containing iodine affect urinary iodine concentrations (UIC) of pregnant women in Malawi.
","['Mangochi District, Malawi', 'pregnant women in Malawi', 'Pregnant women (n 1391', 'pregnant women', 'Women ≤20 weeks pregnant', 'pregnant women with relatively high iodine intakes']","['prenatal supplements containing iodine', 'multiple micronutrients or small-quantity lipid-based nutrient supplements containing iodine', 'consume 60 mg/d Fe and 400 µg/d folic acid (IFA) or 18 vitamins and minerals including 250 µg/d iodine (MMN) or 20 g/d small-quantity lipid-based nutrient supplements (SQ-LNS) with similar nutrient contents as MMN group, plus macronutrients (LNS) until childbirth', 'MMN', 'iron and folic acid']","['geometric mean urinary iodine concentration (UIC', 'neonatal morbidity and mortality', 'urinary iodine concentrations (UIC']","[{'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0460089', 'cui_str': 'Finding of length of gestation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0393847', 'cui_str': 'Motor neuropathy with multiple conduction block'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1391.0,0.378462,"We aimed to evaluate whether prenatal supplements containing iodine affect urinary iodine concentrations (UIC) of pregnant women in Malawi.
","[{'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Adu-Afarwuah', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Legon, Accra, Ghana.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Institute for Global Nutrition and Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'University of Malawi College of Medicine, School of Public Health and Family Medicine, Department of Public Health, Blantyre, Malawi.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'Center for Child Health Research, Tampere University Faculty of Medicine and Health Technology and Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Ashorn', 'Affiliation': 'Center for Child Health Research, Tampere University Faculty of Medicine and Health Technology and Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Josh M', 'Initials': 'JM', 'LastName': 'Jorgensen', 'Affiliation': 'Institute for Global Nutrition and Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Yue-Mei', 'Initials': 'YM', 'LastName': 'Fan', 'Affiliation': 'Center for Child Health Research, Tampere University Faculty of Medicine and Health Technology and Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Minyanga', 'Initials': 'M', 'LastName': 'Nkhoma', 'Affiliation': 'University of Malawi College of Medicine, School of Public Health and Family Medicine, Department of Public Health, Blantyre, Malawi.'}, {'ForeName': 'Jaden', 'Initials': 'J', 'LastName': 'Bendabenda', 'Affiliation': 'University of Malawi College of Medicine, School of Public Health and Family Medicine, Department of Public Health, Blantyre, Malawi.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Matchado', 'Affiliation': 'University of Malawi College of Medicine, School of Public Health and Family Medicine, Department of Public Health, Blantyre, Malawi.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Institute for Global Nutrition and Department of Nutrition, University of California, Davis, CA, USA.'}]",Public health nutrition,['10.1017/S1368980020003250']
2915,33054934,Advertising techniques increase biologic treatment willingness in patients with psoriasis.,"BACKGROUND


Although biologics have revolutionized psoriasis care, some patients may be reluctant to consider implementing biologic therapy.
OBJECTIVE


To determine whether willingness to take a biologic is increased by commonly used advertising techniques.
METHODS


An online survey was used to assess subjects with a self-reported diagnosis of psoriasis and their willingness to initiate biologic treatment (N=400). Subjects were randomized to receive one of the following surveys: clinical data with positive framing (N=80), bandwagon-based statement (N=80), testimonial-based statement (N=80), comparative advertising (N=80), and negative framing (N=80). Willingness to take treatment was recorded on a 10-point Likert scale and evaluated using one-way ANOVA, two-group t-tests, and chi-squared tests.
RESULTS


Compared to subjects presented with positive framing (M=5.5, SD=3.2), subjects presented with a bandwagon-based statement (M=6.5, SD=2.7; P=0.04) and testimonial-based statement (M=7.0, SD=2.7; P=0.01) reported a greater willingness to take treatment, whereas negative framing (M=4.5, SD=3.0; P=0.03) decreased willingness and comparative advertising (M=5.5, SD=2.7; P=0.96) yielded the same willingness as positive framing.
CONCLUSION


Providers might be able to enhance biologic acceptance by utilizing commonly used advertising techniques, such as the bandwagon effect, testimonial effect, and positive framing.",2020,"Compared to subjects presented with positive framing (M=5.5, SD=3.2), subjects presented with a bandwagon-based statement (M=6.5, SD=2.7; P=0.04) and testimonial-based statement (M=7.0, SD=2.7; P=0.01) reported a greater willingness to take treatment, whereas negative framing (M=4.5, SD=3.0; P=0.03) decreased willingness and comparative advertising (M=5.5, SD=2.7; P=0.96) yielded the same willingness as positive framing.
","['patients with psoriasis', 'subjects with a self-reported diagnosis of psoriasis and their willingness to initiate biologic treatment (N=400']","['positive framing (N=80), bandwagon-based statement (N=80), testimonial-based statement (N=80), comparative advertising (N=80), and negative framing']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001690', 'cui_str': 'Advertising as Topic'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",[],,0.040487,"Compared to subjects presented with positive framing (M=5.5, SD=3.2), subjects presented with a bandwagon-based statement (M=6.5, SD=2.7; P=0.04) and testimonial-based statement (M=7.0, SD=2.7; P=0.01) reported a greater willingness to take treatment, whereas negative framing (M=4.5, SD=3.0; P=0.03) decreased willingness and comparative advertising (M=5.5, SD=2.7; P=0.96) yielded the same willingness as positive framing.
","[{'ForeName': 'Jeremy K', 'Initials': 'JK', 'LastName': 'Bray', 'Affiliation': ''}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Masicampo', 'Affiliation': ''}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Feldman', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC Department of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC Department of Pathology, Wake Forest School of Medicine, Winston-Salem, NC. sfeldman@wakehealth.edu.'}]",Dermatology online journal,[]
2916,33055078,"(Ethic)Efficacy of tocilizumab in patients with hand osteoarthritis: double blind, randomised, placebo-controlled, multicentre trial.","OBJECTIVE


To evaluate the efficacy of tocilizumab, an antibody against IL-6 receptor, in patients with hand osteoarthritis.
METHODS


This was a multicentre, 12-week, randomised, double-blind, placebo-controlled study from November 2015 to October 2018. Patients with symptomatic hand osteoarthritis (pain ≥40 on a 0-100 mm visual analogue scale (VAS) despite analgesics and non-steroidal anti-inflammatory drugs; at least three painful joints, Kellgren-Lawrence grade ≥2) were randomised to receive two infusions 4 weeks apart (weeks 0 and 4) of tocilizumab (8 mg/kg intravenous) or placebo. The primary endpoint was changed in VAS pain at week 6. Secondary outcomes included the number of painful and swollen joints, duration of morning stiffness, patients' and physicians' global assessment and function scores.
RESULTS


Of 104 patients screened, 91 (45 to tocilizumab and 46 to placebo; 82% women; mean age 64.4 (SD 8.7) years) were randomly assigned and 79 completed the 12-week study visit. The mean change between baseline and week 6 on the VAS for pain (primary outcome) was -7.9 (SD 19.4) and -9.9 (SD 20.1) in the tocilizumab and placebo groups (p=0.7). The groups did not differ for any secondary outcomes at weeks 4, 6, 8 or 12. Overall, adverse events were slightly more frequent in the tocilizumab than placebo group.
CONCLUSION


Tocilizumab was no more effective than placebo for pain relief in patients with hand osteoarthritis.",2020,"The groups did not differ for any secondary outcomes at weeks 4, 6, 8 or 12.","['patients with hand osteoarthritis', '104 patients screened, 91 (45 to tocilizumab and 46 to placebo; 82% women; mean age 64.4 (SD 8.7) years', 'November 2015 to October 2018', 'Patients with symptomatic hand osteoarthritis (pain ≥40 on a 0-100\u2009mm visual analogue scale (VAS) despite analgesics and non-steroidal anti-inflammatory drugs; at least three painful joints, Kellgren-Lawrence grade ≥2']","['Tocilizumab', 'placebo', 'tocilizumab']","['adverse events', ""number of painful and swollen joints, duration of morning stiffness, patients' and physicians' global assessment and function scores"", 'pain relief', 'VAS pain', 'VAS for pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0457086', 'cui_str': 'Morning stiffness - joint'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.750294,"The groups did not differ for any secondary outcomes at weeks 4, 6, 8 or 12.","[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Richette', 'Affiliation': 'APHP, Hôpital Lariboisière, Service de Rhumatologie, Paris, France pascal.richette@aphp.fr.'}, {'ForeName': 'Augustin', 'Initials': 'A', 'LastName': 'Latourte', 'Affiliation': 'APHP, Hôpital Lariboisière, Service de Rhumatologie, Paris, France.'}, {'ForeName': 'Jérémie', 'Initials': 'J', 'LastName': 'Sellam', 'Affiliation': 'Rheumatology, INSERM UMRS_938, Sorbonnes Université UPMC Univ Paris 06, St-Antoine Hospital, DHU i2B, Paris, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wendling', 'Affiliation': 'Rheumatology, CHU J Minjoz, Besancon, France.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Piperno', 'Affiliation': 'Rheumatology, University Claude Bernard, Lyon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Goupille', 'Affiliation': 'Rheumatology, Trousseau University Hospital, Tours, France.'}, {'ForeName': 'Yves-Marie', 'Initials': 'YM', 'LastName': 'Pers', 'Affiliation': 'Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, CHRU Lapeyronie, Montpellier, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Eymard', 'Affiliation': 'Department of Rheumatology, APHP Henri Mondor Hospital, Créteil, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Ottaviani', 'Affiliation': 'Rheumatology, Hospital Bichat-Claude-Bernard, Paris, Île-de-France, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ornetti', 'Affiliation': 'Rheumatology, Burgundy Franche-Comté University, Dijon, France.'}, {'ForeName': 'René-Marc', 'Initials': 'RM', 'LastName': 'Flipo', 'Affiliation': 'Service de Rhumatologie, CHU Roger Salengro, Université de Lille, Lille, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Fautrel', 'Affiliation': 'Rheumatology, Assistance Publique - Hopitaux de Paris, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Peyr', 'Affiliation': 'Service de Rhumatologie, Hopital Lariboisiere Centre Viggo Petersen, Paris, Île-de-France, France.'}, {'ForeName': 'Jean Pierre', 'Initials': 'JP', 'LastName': 'Bertola', 'Affiliation': 'Medical Affair, Chugai Pharma France SAS, Paris La Defense, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'Unité de recherche clinique, Groupe hospitalier Lariboisiere Fernand-Widal, Paris, Île-de-France, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Chevalier', 'Affiliation': 'Department of Rheumatology, APHP Henri Mondor Hospital, Créteil, France.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-218547']
2917,32224233,Increased fractalkine and vascular dysfunction in obesity and in type 2 diabetes. Effects of oral antidiabetic treatment.,"Activation of fractalkine and other chemokines plays an important role in atherogenesis and, in conjunction with endothelial dysfunction, promotes premature vascular damage in obesity and diabetes. We hypothesized that increased circulating fractalkine coexists with impaired vasomotor function in metabolically healthy or unhealthy obesity, and that treatment with antidiabetic drugs may impact these abnormalities in type 2 diabetes. Compared to lean subjects, in both obese groups the vasodilator responses to acetylcholine and sodium nitroprusside were impaired (both P < .001); ET A -receptor blockade resulted in greater vasodilation (both P < .001); and plasma levels of fractalkine, E-selectin and monocyte chemoattractant protein (MCP)-1 were increased (all P < .05). In diabetic patients, oral antidiabetic drugs (glyburide, metformin or pioglitazone) reduced circulating levels fractalkine and E-selectin (both P < .05), without affecting vascular responses (all P > .05). Our findings indicate that insulin resistant states are associated with elevated atherogenic chemokines and impaired vascular reactivity. Antidiabetic treatment results in lower circulating fractalkine, which may provide cardiovascular benefits.",2020,"Compared to lean subjects, in both obese groups the vasodilator responses to acetylcholine and sodium nitroprusside were impaired (both P < .001); ET A -receptor blockade resulted in greater vasodilation (both P < .001); and plasma levels of fractalkine, E-selectin and monocyte chemoattractant protein (MCP)-1 were increased (all P < .05).",[],"['oral antidiabetic treatment', 'oral antidiabetic drugs (glyburide, metformin or pioglitazone']","['circulating levels fractalkine and E-selectin', 'plasma levels of fractalkine, E-selectin and monocyte chemoattractant protein (MCP)-1', 'vasodilation', 'vascular responses', 'vasodilator responses to acetylcholine and sodium nitroprusside']",[],"[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0535298', 'cui_str': 'Fractalkine'}, {'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0042402', 'cui_str': 'Vasodilator agent'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0037533', 'cui_str': 'Sodium nitroprusside'}]",,0.0303713,"Compared to lean subjects, in both obese groups the vasodilator responses to acetylcholine and sodium nitroprusside were impaired (both P < .001); ET A -receptor blockade resulted in greater vasodilation (both P < .001); and plasma levels of fractalkine, E-selectin and monocyte chemoattractant protein (MCP)-1 were increased (all P < .05).","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Schinzari', 'Affiliation': 'Policlinico A. Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Manfredi', 'Initials': 'M', 'LastName': 'Tesauro', 'Affiliation': 'Department of Internal Medicine, Università Tor Vergata, Roma, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Campia', 'Affiliation': ""Vascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Cardillo', 'Affiliation': 'Policlinico A. Gemelli IRCCS, Roma, Italy; Department of Internal Medicine, Università Cattolica del Sacro Cuore, Roma, Italy. Electronic address: carmine.cardillo@unicatt.it.'}]",Vascular pharmacology,['10.1016/j.vph.2020.106676']
2918,31217488,Eliciting Response Bias Within Forced Choice Tests to Detect Random Responders.,"The Forced Choice Test (FCT) can be used to detect malingered loss of memory or sensory deficits. In this test, examinees are presented with two stimuli, one correct and one incorrect, in regards to a specific event or a perceptual discrimination task. The task is to select the correct answer alternative, or guess if it is unknown. Genuine impairment is associated with test scores that fall within chance performance. In contrast, malingered impairment is associated with purposeful avoidance of correct information, resulting in below chance performance. However, a substantial proportion of malingerers intentionally randomize their responses, and are missed by the test. Here we examine whether a 'runs test' and a 'within test response 'bias' have diagnostic value to detect this intentional randomization. We instructed 73 examinees to malinger red/green blindness and subjected them to a FCT. For half of the examinees we manipulated the ambiguity between answer alternatives over the test trials in order to elicit a response bias. Compared to a sample of 10,000 cases of computer generated genuine performance, the runs test and response bias both detected malingered performance better than chance.",2019,"Compared to a sample of 10,000 cases of computer generated genuine performance, the runs test and response bias both detected malingered performance better than chance.",[],['73 examinees to malinger red/green blindness and subjected them to a FCT'],['Eliciting Response Bias'],[],"[{'cui': 'C0024630', 'cui_str': 'Malingering'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0005346', 'cui_str': 'Biases'}]",10000.0,0.0317213,"Compared to a sample of 10,000 cases of computer generated genuine performance, the runs test and response bias both detected malingered performance better than chance.","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Orthey', 'Affiliation': 'Department of Psychology, University of Portsmouth, PO1 2DY, Portsmouth, United Kingdom. robinorthey@googlemail.com.'}, {'ForeName': 'Aldert', 'Initials': 'A', 'LastName': 'Vrij', 'Affiliation': 'Department of Psychology, University of Portsmouth, PO1 2DY, Portsmouth, United Kingdom.'}, {'ForeName': 'Ewout', 'Initials': 'E', 'LastName': 'Meijer', 'Affiliation': 'Faculty of Psychology & Neuroscience, Maastricht University, 622MD, Maastricht, The Netherlands.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Leal', 'Affiliation': 'Department of Psychology, University of Portsmouth, PO1 2DY, Portsmouth, United Kingdom.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Blank', 'Affiliation': 'Department of Psychology, University of Portsmouth, PO1 2DY, Portsmouth, United Kingdom.'}]",Scientific reports,['10.1038/s41598-019-45292-y']
2919,31217549,Association of sleep quality with job burnout among Chinese coal mine staff: a propensity score weighting analysis.,"This study examines the association of sleep quality with job burnout among Chinese coal mine staff. 3832 subjects were selected from a coal mine group located in Shanxi Province in China. Job burnout was evaluated by the Maslach Burnout Inventory-General Survey and sleep quality was acquired with a self-reported questionnaire. We used the inverse probability of treatment weighting with propensity score to mimic the randomization and to minimize bias in estimations. Sensitivity analysis was conducted to test the robustness of our findings. We identified that good sleep quality was significantly associated with lower risk of job burnout (OR: 0.70; 95%CI, 0.60 to 0.82, p = 6.02e-06), with 0.21 decrease in the score of exhaustion (95%CI,-0.29 to -0.12, p = 5.00e-06), and with 0.13 decrease in the score of cynicism (95%CI,-0.21 to -0.04, p = 3.73e-03). Sensitivity analysis demonstrated that the results were robust to the choice of estimation models, as well as unmeasured confounding. Stratification analysis demonstrated that the associations of sleep quality with job burnout were largely heterogeneous for male and female workers. This study implicated that good sleep quality benefits the workers in relief of job burnout. Further research may be warranted in support of a definite causal relationship and intervention strategy.",2019,"We identified that good sleep quality was significantly associated with lower risk of job burnout (OR: 0.70; 95%CI, 0.60 to 0.82, p = 6.02e-06), with 0.21 decrease in the score of exhaustion (95%CI,-0.29 to -0.12, p = 5.00e-06), and with 0.13 decrease in the score of cynicism (95%CI,-0.21 to -0.04, p = 3.73e-03).","['3832 subjects were selected from a coal mine group located in Shanxi Province in China', 'Chinese coal mine staff']",[],"['score of exhaustion', 'good sleep quality', 'sleep quality', 'Maslach Burnout Inventory-General Survey and sleep quality']","[{'cui': 'C0562021', 'cui_str': 'Coal mine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",3832.0,0.0422281,"We identified that good sleep quality was significantly associated with lower risk of job burnout (OR: 0.70; 95%CI, 0.60 to 0.82, p = 6.02e-06), with 0.21 decrease in the score of exhaustion (95%CI,-0.29 to -0.12, p = 5.00e-06), and with 0.13 decrease in the score of cynicism (95%CI,-0.21 to -0.04, p = 3.73e-03).","[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Health Statistics, School of Public Health, Shanxi Medical University, 56 Xinjiannanlu Street, Taiyuan, Shanxi, 030001, China.'}, {'ForeName': 'Kai-Li', 'Initials': 'KL', 'LastName': 'Ma', 'Affiliation': 'Department of Health Statistics, School of Public Health, Shanxi Medical University, 56 Xinjiannanlu Street, Taiyuan, Shanxi, 030001, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Health Statistics, School of Public Health, Shanxi Medical University, 56 Xinjiannanlu Street, Taiyuan, Shanxi, 030001, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Department of Health Statistics, School of Public Health, Shanxi Medical University, 56 Xinjiannanlu Street, Taiyuan, Shanxi, 030001, China.'}, {'ForeName': 'Li-Jian', 'Initials': 'LJ', 'LastName': 'Lei', 'Affiliation': 'Department of Epidemiology, School of Public Health, Shanxi Medical University, 56 Xinjiannanlu Street, Taiyuan, Shanxi, 030001, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Health Statistics, School of Public Health, Shanxi Medical University, 56 Xinjiannanlu Street, Taiyuan, Shanxi, 030001, China. tongwang@sxmu.edu.cn.'}]",Scientific reports,['10.1038/s41598-019-45329-2']
2920,33057936,"The impact of low pressure pneumoperitoneum in robotic assisted radical prostatectomy: a prospective, randomized, double blinded trial.","BACKGROUND


Robotic surgery has revolutionized postoperative outcomes across surgical specialties. However, the use of pneumoperitoneum comes with known risks given the change in physiological parameters that accompany its utilization. A recent internal review found a 7% decrease in postoperative ileus rates when utilizing a pneumoperitoneum of 12 mmHg over the standard 15 mmHg in robotic assisted radical prostatectomies (RARP).
OBJECTIVE


The purpose of this study is to prospectively evaluate the utility of lower pressure pneumoperitoneum by comparing 8 mmHg and 12 mmHg during RARP.
DESIGN, SETTING AND PARTCIPANTS


Patients were randomly assigned to undergo robotic assisted radical prostatectomy at a pneumoperitoneum pressure of 12 mmHg or 8 mmHg.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary outcome was development of postoperative ileus and secondary outcomes were length of operation, estimated blood loss and positive surgical margin status.
RESULTS AND LIMITATIONS


A total of 201 patients were analyzed; 96 patients at 8 mmHg and 105 patients at 12 mmHg. The groups were adequately matched as there were no differences between demographic parameters or medical comorbidities. There was a decrease in postoperative ileus rates with lower pneumoperitoneum pressures; 2% at 8 mmHg and 4.8% at 12 mmHg. There were no clinically significant differences in estimated blood loss, total length of operative time and positive margin status.
CONCLUSIONS


Lower pressure pneumoperitoneum during robotic assisted radical prostatectomy is non-inferior to higher pressure pneumoperitoneum levels and the experienced surgeon may safely perform this operation at 8 mmHg to take advantage of the proposed benefits.",2020,"CONCLUSIONS


Lower pressure pneumoperitoneum during robotic assisted radical prostatectomy is non-inferior to higher pressure pneumoperitoneum levels and the experienced surgeon may safely perform this operation at 8 ","['201 patients were analyzed; 96 patients at 8\xa0mmHg and 105 patients at 12\xa0mmHg', 'Patients']","['low pressure pneumoperitoneum', 'robotic assisted radical prostatectomy', 'Lower pressure pneumoperitoneum during robotic assisted radical prostatectomy', 'robotic assisted radical prostatectomy at a pneumoperitoneum pressure of 12\xa0mmHg or 8\xa0mmHg']","['development of postoperative ileus and secondary outcomes were length of operation, estimated blood loss and positive surgical margin status', 'estimated blood loss, total length of operative time and positive margin status', 'postoperative ileus rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",201.0,0.117525,"CONCLUSIONS


Lower pressure pneumoperitoneum during robotic assisted radical prostatectomy is non-inferior to higher pressure pneumoperitoneum levels and the experienced surgeon may safely perform this operation at 8 ","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Rohloff', 'Affiliation': 'Department of Urological Surgery, Metro Health: University of Michigan Health, 5900 Byron Center Ave., Wyoming, MI, 49519, USA. Matthew.Rohloff@metrogr.org.'}, {'ForeName': 'Greggory', 'Initials': 'G', 'LastName': 'Peifer', 'Affiliation': 'Department of Urological Surgery, Metro Health: University of Michigan Health, 5900 Byron Center Ave., Wyoming, MI, 49519, USA.'}, {'ForeName': 'Jaschar', 'Initials': 'J', 'LastName': 'Shakuri-Rad', 'Affiliation': 'Department of Urological Surgery, Metro Health: University of Michigan Health, 5900 Byron Center Ave., Wyoming, MI, 49519, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Maatman', 'Affiliation': 'Department of Urological Surgery, Metro Health: University of Michigan Health, 5900 Byron Center Ave., Wyoming, MI, 49519, USA.'}]",World journal of urology,['10.1007/s00345-020-03486-4']
2921,33058035,"Correction to: In shoulder adhesive capsulitis, ultrasound-guided anterior hydrodilatation in rotator interval is more effective than posterior approach: a randomized controlled study.",The authors of the original version of the above article requested to add the name of the instrument that was used in the Intervention section.,2020,The authors of the original version of the above article requested to add the name of the instrument that was used in the Intervention section.,[],['ultrasound-guided anterior hydrodilatation'],[],[],"[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}]",[],,0.0456974,The authors of the original version of the above article requested to add the name of the instrument that was used in the Intervention section.,"[{'ForeName': 'Basant', 'Initials': 'B', 'LastName': 'Elnady', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Elsayed M', 'Initials': 'EM', 'LastName': 'Rageh', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Manal Shawky', 'Initials': 'MS', 'LastName': 'Hussein', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohammed Hassan', 'Initials': 'MH', 'LastName': 'Abu-Zaid', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Dalia El-Sayed', 'Initials': 'DE', 'LastName': 'Desouky', 'Affiliation': 'Department of public health and community medicine, Menoufia University, Shibin Al Kawm, Egypt.'}, {'ForeName': 'Tohamy', 'Initials': 'T', 'LastName': 'Ekhouly', 'Affiliation': 'Department of Radiology, Benha University, Benha, Egypt.'}, {'ForeName': 'Johannes J', 'Initials': 'JJ', 'LastName': 'Rasker', 'Affiliation': 'Faculty of Behavioral, Management and Social sciences, Department Psychology, Health and Technology, University of Twente, PO box 217, 7500 AE, Enschede, Netherlands. j.j.rasker@utwente.nl.'}]",Clinical rheumatology,['10.1007/s10067-020-05461-1']
2922,33058094,The Double Stitch Everting Technique in the End-to-Side Microvascular Anastomosis: Validation of the Technique Using a Randomized N-of-1 Trial.,"BACKGROUND


The double stitch everting (DSE) technique, in which time is won by leaving the needle inside the vessel wall in-between stitching, is a modification of the end-to-side (ETS) anastomosis in the interest of reducing anastomosis time. This ensures proper wall eversion, intima-to-intima contact, and improved suture symmetry.
MATERIALS AND METHODS


We designed an N-of-1 randomized trial with each microsurgeon as their own control. We included 10 microsurgeons of different levels of experience who were then asked to perform classic and DSE ETS anastomoses on the chicken leg and rat femoral models. Every anastomosis was cut and evaluated using blinded assessment. Two-way analysis of variance (ANOVA) and multivariable logistic regression were used to analyze the results and for confounder adjustment.
RESULTS


A total of 210 anastomoses were performed, of which 177 on the chicken leg and 43 on the rat femoral artery and vein. From the 210 anastomoses, 111 were performed using the classic technique and 99 using the DSE technique. The mean anastomosis time was 28.8 ± 11.3 minutes in the classic group and 24.6 ± 12 minutes in the DSE group ( p  < 0.001,  t -test). There was a significant reduction ( p  < 0.001, two-way ANOVA) in the number of mistakes when using the DSE technique (mean 5.5 ± 2.6) compared with those using the classic technique (mean 7.7 ± 3.4).
CONCLUSION


The DSE technique for ETS anastomoses improves anastomoses times in experienced and moderately experienced microsurgeons while also improving or maintaining suture symmetry and lowering the number of mistakes.",2020,"There was a significant reduction ( p  < 0.001, two-way ANOVA) in the number of mistakes when using the DSE technique (mean 5.5 ± 2.6) compared with those using the classic technique (mean 7.7 ± 3.4).
","['10 microsurgeons of different levels of experience who were then asked to perform classic and DSE ETS anastomoses on the chicken leg and rat femoral models', 'A total of 210 anastomoses were performed, of which 177 on the chicken leg and 43 on the rat femoral artery and vein']",['double stitch everting (DSE) technique'],"['mean anastomosis time', 'anastomoses times']","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0332857', 'cui_str': 'Anastomosis, end to side'}, {'cui': 'C0008051', 'cui_str': 'Gallus gallus'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",210.0,0.0314547,"There was a significant reduction ( p  < 0.001, two-way ANOVA) in the number of mistakes when using the DSE technique (mean 5.5 ± 2.6) compared with those using the classic technique (mean 7.7 ± 3.4).
","[{'ForeName': 'George C', 'Initials': 'GC', 'LastName': 'Dindelegan', 'Affiliation': 'Department of Surgery, First Surgical Clinic, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Dammers', 'Affiliation': 'Department of Neurosurgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Alex V', 'Initials': 'AV', 'LastName': 'Oradan', 'Affiliation': 'Department of Experimental Microsurgery, Center for Surgical Simulation, Training and Microsurgery, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Ramona C', 'Initials': 'RC', 'LastName': 'Vinasi', 'Affiliation': 'Department of Experimental Microsurgery, Center for Surgical Simulation, Training and Microsurgery, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Dindelegan', 'Affiliation': 'Department of Experimental Microsurgery, Center for Surgical Simulation, Training and Microsurgery, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Volovici', 'Affiliation': 'Department of Experimental Microsurgery, Center for Surgical Simulation, Training and Microsurgery, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}]",Journal of reconstructive microsurgery,['10.1055/s-0040-1718548']
2923,33058158,Targeted therapy for metastatic renal cell carcinoma.,"BACKGROUND


Several comparative randomised controlled trials (RCTs) have been performed including combinations of tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors since the publication of a Cochrane Review on targeted therapy for metastatic renal cell carcinoma (mRCC) in 2008. This review represents an update of that original review.
OBJECTIVES


To assess the effects of targeted therapies for clear cell mRCC in patients naïve to systemic therapy.
SEARCH METHODS


We performed a comprehensive search with no restrictions on language or publication status. The date of the latest search was 18 June 2020.
SELECTION CRITERIA


We included randomised controlled trials, recruiting patients with clear cell mRCC naïve to previous systemic treatment. The index intervention was any TKI-based targeted therapy.
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed the included studies and extracted data for the primary outcomes: progression-free survival (PFS), overall survival (OS) and serious adverse events (SAEs); and the secondary outcomes: health-related quality of life (QoL), response rate and minor adverse events (AEs). We performed statistical analyses using a random-effects model and rated the certainty of evidence according to the GRADE approach.
MAIN RESULTS


We included 18 RCTs reporting on 11,590 participants randomised across 18 comparisons. This abstract focuses on the primary outcomes of select comparisons. 1. Pazopanib versus sunitinib Pazopanib may result in little to no difference in PFS as compared to sunitinib (hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.90 to 1.23; 1 study, 1110 participants; low-certainty evidence). Based on the control event risk of 420 per 1000 in this trial at 12 months, this corresponds to 18 fewer participants experiencing PFS (95% CI 76 fewer to 38 more) per 1000 participants. Pazopanib may result in little to no difference in OS compared to sunitinib (HR 0.92, 95% CI 0.80 to 1.06; 1 study, 1110 participants; low-certainty evidence). Based on the control event risk of 550 per 1000 in this trial at 12 months, this corresponds to 27 more OSs (95% CI 19 fewer to 70 more) per 1000 participants. Pazopanib may result in little to no difference in SAEs as compared to sunitinib (risk ratio (RR) 1.01, 95% CI 0.94 to 1.09; 1 study, 1102 participants; low-certainty evidence). Based on the control event risk of 734 per 1000 in this trial, this corresponds to 7 more participants experiencing SAEs (95% CI 44 fewer to 66 more) per 1000 participants. 2. Sunitinib versus avelumab and axitinib Sunitinib probably reduces PFS as compared to avelumab plus axitinib (HR 1.45, 95% CI 1.17 to 1.80; 1 study, 886 participants; moderate-certainty evidence). Based on the control event risk of 550 per 1000 in this trial at 12 months, this corresponds to 130 fewer participants experiencing PFS (95% CI 209 fewer to 53 fewer) per 1000 participants. Sunitinib may result in little to no difference in OS (HR 1.28, 95% CI 0.92 to 1.79; 1 study, 886 participants; low-certainty evidence). Based on the control event risk of 890 per 1000 in this trial at 12 months, this would result in 29 fewer OSs (95% CI 78 fewer to 8 more) per 1000 participants. Sunitinib may result in little to no difference in SAEs (RR 1.01, 95% CI 0.93 to 1.10; 1 study, 873 participants; low-certainty evidence). Based on the control event risk of 705 per 1000 in this trial, this corresponds to 7 more SAEs (95% CI 49 fewer to 71 more) per 1000 participants.  3. Sunitinib versus pembrolizumab and axitinib Sunitinib probably reduces PFS as compared to pembrolizumab plus axitinib (HR 1.45, 95% CI 1.19 to 1.76; 1 study, 861 participants; moderate-certainty evidence). Based on the control event risk of 590 per 1000 in this trial at 12 months, this corresponds to 125 fewer participants experiencing PFS (95% CI 195 fewer to 56 fewer) per 1000 participants. Sunitinib probably reduces OS (HR 1.90, 95% CI 1.36 to 2.65; 1 study, 861 participants; moderate-certainty evidence). Based on the control event risk of 880 per 1000 in this trial at 12 months, this would result in 96 fewer OSs (95% CI 167 fewer to 40 fewer) per 1000 participants. Sunitinib may reduce SAEs as compared to pembrolizumab plus axitinib (RR 0.90, 95% CI 0.81 to 1.02; 1 study, 854 participants; low-certainty evidence) although the CI includes the possibility of no effect. Based on the control event risk of 604 per 1000 in this trial, this corresponds to 60 fewer SAEs (95% CI 115 fewer to 12 more) per 1000 participants.  4. Sunitinib versus nivolumab and ipilimumab Sunitinib may reduce PFS as compared to nivolumab plus ipilimumab (HR 1.30, 95% CI 1.11 to 1.52; 1 study, 847 participants; low-certainty evidence). Based on the control event risk of 280 per 1000 in this trial at 30 months' follow-up, this corresponds to 89 fewer PFSs (95% CI 136 fewer to 37 fewer) per 1000 participants. Sunitinib reduces OS (HR 1.52, 95% CI 1.23 to 1.89; 1 study, 847 participants; high-certainty evidence). Based on the control event risk 600 per 1000 in this trial at 30 months, this would result in 140 fewer OSs (95% CI 219 fewer to 67 fewer) per 1000 participants. Sunitinib probably increases SAEs (RR 1.37, 95% CI 1.22 to 1.53; 1 study, 1082 participants; moderate-certainty evidence). Based on the control event risk of 457 per 1000 in this trial, this corresponds to 169 more SAEs (95% CI 101 more to 242 more) per 1000 participants.
AUTHORS' CONCLUSIONS


Based on the low to high certainty of evidence, several combinations of immune checkpoint inhibitors appear to be superior to single-agent targeted therapy in terms of PFS and OS, and with a favourable AE profile. Some single-agent targeted therapies demonstrated a similar or improved oncological outcome compared to others; minor differences were observed for AE within this group. The certainty of evidence was variable ranging from high to very low and all comparisons were based on single trials.",2020,"Sunitinib reduces OS (HR 1.52, 95% CI 1.23 to 1.89; 1 study, 847 participants; high-certainty evidence).","['patients with clear cell mRCC naïve to previous systemic treatment', 'metastatic renal cell carcinoma (mRCC) in 2008', 'patients naïve to systemic therapy', 'metastatic renal cell carcinoma', '18 RCTs reporting on 11,590 participants randomised across 18 comparisons']","['Sunitinib versus pembrolizumab and axitinib Sunitinib', 'Sunitinib versus avelumab and axitinib Sunitinib', 'Pazopanib', 'Sunitinib versus nivolumab and ipilimumab Sunitinib']","['Sunitinib reduces OS', 'progression-free survival (PFS), overall survival (OS) and serious adverse events (SAEs); and the secondary outcomes: health-related quality of life (QoL), response rate and minor adverse events (AEs', 'oncological outcome', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2931852', 'cui_str': 'Clear-cell metastatic renal cell carcinoma'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026193', 'cui_str': 'Minor'}]",11590.0,0.363965,"Sunitinib reduces OS (HR 1.52, 95% CI 1.23 to 1.89; 1 study, 847 participants; high-certainty evidence).","[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Hofmann', 'Affiliation': 'Department of Urology, Sunderby Sjukhus, Umeå University, Luleå, Sweden.'}, {'ForeName': 'Eu Chang', 'Initials': 'EC', 'LastName': 'Hwang', 'Affiliation': 'Department of Urology, Chonnam National University Medical School, Chonnam National University Hwasun Hospital, Hwasun, Korea, South.'}, {'ForeName': 'Thomas Bl', 'Initials': 'TB', 'LastName': 'Lam', 'Affiliation': 'Academic Urology Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Bex', 'Affiliation': 'Department of Urology and UCL Division of Surgery and Interventional Science, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Yuhong', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Lorenzo So', 'Initials': 'LS', 'LastName': 'Marconi', 'Affiliation': 'Department of Urology and Renal Transplantation, Centro Hospitalar e Universitario de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Börje', 'Initials': 'B', 'LastName': 'Ljungberg', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Umeå University, Umeå, Sweden.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012796.pub2']
2924,33058232,The CRIAA Program complex intervention in primary care to support women and their families in breastfeeding: Study protocol for a pilot trial.,"AIM


To report a pilot study protocol to assess the feasibility of a complex intervention, in the primary healthcare context, to support women and their families in breastfeeding.
DESIGN


A pilot/feasibility trial with control and intervention groups.
METHODS


The study will be conducted in two primary healthcare centres with 40 childbearing women (20 control group; 20 intervention group), with their partner/meaningful person and their respective healthcare professionals. Intervention group participants will receive the intervention: (a) in a breastfeeding workshop during their third trimester of pregnancy; and (b) via virtual breastfeeding support for six months postpartum. Health professionals will be trained to deliver the intervention. The control group will receive standard care in the outpatient clinic. The pilot will help determine the intervention's feasibility. Data collected pre-intervention, 10-days postpartum and two-, four-, and six-months postpartum will provide estimates of the intervention's preliminary effects on self-efficacy and main outcomes. Research Ethics Committee approval was obtained in April 2019.
DISCUSSION


Breastfeeding support is a complex reality influenced by multiple factors. Therefore, approaches to breastfeeding are also, requiring interventions that address its multidimensional nature, including all actors involved. The proposed intervention will be applied by an interdisciplinary professional health team, allowing for its incorporation into standard practice and its perpetual maintenance.
IMPACT


The study will produce an original, comprehensive, complex intervention addressing contextual, and organizational factors to promote breastfeeding support using an interdisciplinary and family-based approach; breastfeeding self-efficacy is the core concept. The program evaluation and feasibility study will permit exploration of the integration of the intervention's novel aspects into the daily work of professionals and reveal how to better use existing resources in a full-scale clinical trial.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT03944642.",2020,"The program evaluation and feasibility study will permit exploration of the integration of the intervention's novel aspects into the daily work of professionals and reveal how to better use existing resources in a full-scale clinical trial.
","['two primary healthcare centres with 40 childbearing women (20 control group; 20 intervention group), with their partner/meaningful person and their respective healthcare professionals', 'support women and their families in breastfeeding', 'primary care to support women and their families in breastfeeding']","['complex intervention', 'breastfeeding workshop during their third trimester of pregnancy; and (b) via virtual breastfeeding support for six months postpartum']",[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1171181', 'cui_str': 'Breastfeeding support'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]",[],2.0,0.0536521,"The program evaluation and feasibility study will permit exploration of the integration of the intervention's novel aspects into the daily work of professionals and reveal how to better use existing resources in a full-scale clinical trial.
","[{'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Lucchini-Raies', 'Affiliation': 'School of Nursing, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Marquez-Doren', 'Affiliation': 'Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Beca', 'Affiliation': 'School of Medicine, Family Health Center San Alberto Hurtado ANCORA, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'J Carola', 'Initials': 'JC', 'LastName': 'Perez', 'Affiliation': 'Faculty of Psychology, Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Campos', 'Affiliation': 'School of Nursing, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Lopez-Dicastillo', 'Affiliation': 'Faculty of Nursing, Universidad Pública de Navarra, Pamplona, Spain.'}]",Journal of advanced nursing,['10.1111/jan.14534']
2925,33058259,The nonparametric Behrens-Fisher problem in partially complete clustered data.,"In randomized trials or observational studies involving clustered units, the assumption of independence within clusters is not practical. Existing parametric or semiparametric methods assume specific dependence structures within a cluster. Furthermore, parametric model assumptions may not even be realistic when data are measured in a nonmetric scale as commonly happens, for example, in quality-of-life outcomes. In this paper, nonparametric effect-size measures for clustered data that allow meaningful and interpretable probabilistic comparisons of treatments or intervention programs will be introduced. The dependence among observations within a cluster can be arbitrary. Point estimators along with their asymptotic properties for computing confidence intervals and performing hypothesis test will be discussed. Small sample approximations that retain some of the optimal asymptotic behaviors will be presented. In our setup, some clusters may involve observations coming from both intervention groups (referred to as complete clusters), while others may contain observations from one group only (referred to as incomplete clusters). In deriving the asymptotic theories, we do not impose any relation in the rate of divergence of the numbers of complete and incomplete clusters. Simulations show favorable performance of the methods for arbitrary combinations of complete and incomplete clusters. The developed nonparametric methods are illustrated using data from a randomized trial of indoor wood smoke reduction to improve asthma symptoms and a cluster-randomized trial for smoking cessation.",2020,The developed nonparametric methods are illustrated using data from a randomized trial of indoor wood smoke reduction to improve asthma symptoms and a cluster-randomized trial for smoking cessation.,[],['indoor wood smoke reduction'],[],[],"[{'cui': 'C0043217', 'cui_str': 'Wood'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",[],,0.0860612,The developed nonparametric methods are illustrated using data from a randomized trial of indoor wood smoke reduction to improve asthma symptoms and a cluster-randomized trial for smoking cessation.,"[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Mathematics, Missouri State University, Springfield, MO, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Konietschke', 'Affiliation': 'Charité, - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Biometry and Clinical Epidemiology, Berlin, Germany.'}, {'ForeName': 'Solomon W', 'Initials': 'SW', 'LastName': 'Harrar', 'Affiliation': 'Dr. Bing Zhang Department of Statistics, University of Kentucky, Lexington, KY, USA.'}]",Biometrical journal. Biometrische Zeitschrift,['10.1002/bimj.201900310']
2926,33058553,Bioequivalence and Evaluation Parameters Based on the Pharmacodynamics of Miglitol in Healthy Volunteers.,"The aim of this study was to explore the bioequivalence of miglitol based on pharmacodynamic properties. The study was performed as a single-dose, randomized, open-label, 3-period, 3-way crossover trial over a 7-day washout period. Forty-eight subjects were randomly assigned into 3 groups: (1) miglitol test formulation/sucrose coadministration, (2) miglitol reference formulation/sucrose coadministration, and (3) sucrose administration alone. Serum glucose concentrations were measured by the hexokinase detection method. The peak serum glucose concentration (C max  ) and the area under the serum glucose concentration-time curve through 4 hours (AUC 0-4h  ) were used as the main pharmacodynamic parameters to evaluate bioequivalence. The 90% confidence intervals for the geometric mean ratios of C max  and AUC 0-4h  were 94.81%-101.07% and 98.82%-100.72%, respectively, which were all within the bioequivalence range of 80.00%-125.00%. The test and reference formulations of miglitol were pharmacodynamically bioequivalent during the trial.",2020,"The 90% confidence intervals for the geometric mean ratios of C max  and AUC 0-4h  were 94.81%-101.07% and 98.82%-100.72%, respectively, which were all within the bioequivalence range of 80.00%-125.00%.","['Healthy Volunteers', 'Forty-eight subjects']","['miglitol test formulation/sucrose coadministration, (2) miglitol reference formulation/sucrose coadministration, and (3) sucrose administration alone']","['geometric mean ratios of C max  and AUC 0-4h', 'Serum glucose concentrations', 'peak serum glucose concentration (C max  ) and the area under the serum glucose concentration-time curve']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319608', 'cui_str': '48'}]","[{'cui': 'C0066535', 'cui_str': 'miglitol'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",48.0,0.0175138,"The 90% confidence intervals for the geometric mean ratios of C max  and AUC 0-4h  were 94.81%-101.07% and 98.82%-100.72%, respectively, which were all within the bioequivalence range of 80.00%-125.00%.","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiao-Min', 'Initials': 'XM', 'LastName': 'Li', 'Affiliation': 'Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yan-Xin', 'Initials': 'YX', 'LastName': 'Zhang', 'Affiliation': 'Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Su-Mei', 'Initials': 'SM', 'LastName': 'Xu', 'Affiliation': 'Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Wan-Li', 'Initials': 'WL', 'LastName': 'Liu', 'Affiliation': 'Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiao-Lei', 'Initials': 'XL', 'LastName': 'Hu', 'Affiliation': 'Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zou', 'Affiliation': 'Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yu-Ying', 'Initials': 'YY', 'LastName': 'Xu', 'Affiliation': 'Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Ping-Sheng', 'Initials': 'PS', 'LastName': 'Xu', 'Affiliation': 'Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.873']
2927,33058694,"Development of the English Listening and Reading Computerized Revised Token Test Into Cantonese: Validity, Reliability, and Sensitivity/Specificity in People With Aphasia and Healthy Controls.","Purpose This study reports the psychometric development of the Cantonese versions of the English Computerized Revised Token Test (CRTT) for persons with aphasia (PWAs) and healthy controls (HCs). Method The English CRTT was translated into standard Chinese for the Reading-Word Fade version (CRTT-R- WF -Cantonese) and into formal Cantonese for the Listening version (CRTT-L-Cantonese). Thirty-two adult native Cantonese PWAs and 42 HCs were tested on both versions of CRTT-Cantonese tests and on the Cantonese Aphasia Battery to measure the construct and concurrent validity of CRTT-Cantonese tests. The HCs were retested on both versions of the CRTT-Cantonese tests, whereas the PWAs were randomly assigned for retesting on either version to measure the test-retest reliability. Results A two-way, Group × Modality, repeated-measures analysis of variance revealed significantly lower scores for the PWA group than the HC group for both reading and listening. Other comparisons were not significant. A high and significant correlation was found between the CRTT-R- WF -Cantonese and the CRTT-L-Cantonese in PWAs, and 87% of the PWAs showed nonsignificantly different performance across the CRTT-Cantonese tests based on the Revised Standardized Difference Test. The CRTT-R- WF -Cantonese provided better aphasia diagnostic sensitivity (100%) and specificity (83.30%) values than the CRTT-L-Cantonese. Pearson correlation coefficients revealed significant moderate correlations between the Cantonese Aphasia Battery scores and the CRTT-Cantonese tests in PWAs, supporting adequate concurrent validity. Intraclass correlation coefficient showed high test-retest reliability (between .82 and .96,  p  < .001) for both CRTT-Cantonese tests for both groups. Conclusions Results support that the validly translated CRTT-R- WF -Cantonese and CRTT-L-Cantonese tests significantly differentiate the reading and listening comprehension of PWAs from HCs and provides acceptable concurrent validity and high test-retest reliability for both tests. Furthermore, favorable PWA versus HC sensitivity and specificity cutoff scores are presented for both CRTT-Cantonese listening and reading tests.",2020,The CRTT-R- WF -Cantonese provided better aphasia diagnostic sensitivity (100%) and specificity (83.30%) values than the CRTT-L-Cantonese.,"['persons with aphasia (PWAs) and healthy controls (HCs', 'People With Aphasia and Healthy Controls', 'Thirty-two adult native Cantonese PWAs and 42 HCs']",['English Computerized Revised Token Test (CRTT'],"['aphasia diagnostic sensitivity', 'favorable PWA versus HC sensitivity and specificity cutoff scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}]","[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0582662', 'cui_str': 'Revised token test'}]","[{'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",32.0,0.0194605,The CRTT-R- WF -Cantonese provided better aphasia diagnostic sensitivity (100%) and specificity (83.30%) values than the CRTT-L-Cantonese.,"[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Bakhtiar', 'Affiliation': 'Department of Chinese and Bilingual Studies, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Min Ney', 'Initials': 'MN', 'LastName': 'Wong', 'Affiliation': 'Department of Chinese and Bilingual Studies, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Emily Ka Yin', 'Initials': 'EKY', 'LastName': 'Tsui', 'Affiliation': 'Department of Chinese and Bilingual Studies, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Malcolm R', 'Initials': 'MR', 'LastName': 'McNeil', 'Affiliation': 'Department of Communication Science and Disorders, University of Pittsburgh, PA.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-20-00103']
2928,33058735,"The Effectiveness of a Virtual Reality-Based Intervention on Cognitive Functions in Older Adults with Mild Cognitive Impairment: A Single-Blind, Randomized Controlled Trial.","Objective:  Mild cognitive impairment (MCI) is a broad term for people at a stage between normal age-related cognitive decline and dementia, where cognitive problems are present but do not impair activities of daily living. This study aimed at evaluating the effectiveness of a virtual reality (VR)-based rehabilitation program on cognitive functions in MCI.  Materials and Methods:  Sixty-one older adults (25 men, 36 women) with MCI were randomized to the intervention group ( n  = 30; 70.12 ± 2.57 years) or control ( n  = 31; 70.30 ± 2.73 years) group. The intervention group received a VR (computer-generated interactive environments) intervention in addition to a conventional cognitive rehabilitation (CR) intervention, whereas the control group received only the CR intervention. Cognitive functions were assessed in both groups before and after the 12-week interventions by using the Loewenstein Occupational Therapy Cognitive Assessment-Geriatric.  Results:  Between-group comparisons revealed significantly greater improvements in orientation, visual-spatial perception, visuomotor organization, thinking operation, and attention/concentration functions in the VR group than in the control group ( P  < 0.001 for all).  Conclusion:  Our results showed that 12 weeks of VR-based rehabilitation enhanced cognitive functions in older adults with MCI. Using VR applications in CR is recommended to improve cognitive functions of older adults with MCI.",2020,"Results:  Between-group comparisons revealed significantly greater improvements in orientation, visual-spatial perception, visuomotor organization, thinking operation, and attention/concentration functions in the VR group than in the control group ( P  < 0.001 for all).  ","['Sixty-one older adults (25 men, 36 women) with MCI', 'Older Adults with Mild Cognitive Impairment', 'people at a stage between normal age-related cognitive decline and dementia', 'older adults with MCI']","['VR-based rehabilitation', 'control group received only the CR intervention', 'virtual reality (VR)-based rehabilitation program', 'Virtual Reality-Based Intervention', 'VR (computer-generated interactive environments) intervention in addition to a conventional cognitive rehabilitation (CR) intervention', 'Mild cognitive impairment (MCI']","['orientation, visual-spatial perception, visuomotor organization, thinking operation, and attention/concentration functions', 'Cognitive Functions', 'cognitive functions', 'Cognitive functions']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0560005', 'cui_str': 'mCi'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0236848', 'cui_str': 'Age-related cognitive decline'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0560005', 'cui_str': 'mCi'}]","[{'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0037744', 'cui_str': 'Space Perception'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",61.0,0.0226081,"Results:  Between-group comparisons revealed significantly greater improvements in orientation, visual-spatial perception, visuomotor organization, thinking operation, and attention/concentration functions in the VR group than in the control group ( P  < 0.001 for all).  ","[{'ForeName': 'Berkan', 'Initials': 'B', 'LastName': 'Torpil', 'Affiliation': 'Department of Occupational Therapy, Faculty of Gülhane Health Sciences, University of Health Sciences Turkey, Ankara, Turkey.'}, {'ForeName': 'Sedef', 'Initials': 'S', 'LastName': 'Şahin', 'Affiliation': 'Department of Occupational Therapy, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Pekçetin', 'Affiliation': 'Department of Occupational Therapy, Faculty of Gülhane Health Sciences, University of Health Sciences Turkey, Ankara, Turkey.'}, {'ForeName': 'Mine', 'Initials': 'M', 'LastName': 'Uyanık', 'Affiliation': 'Department of Occupational Therapy, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey.'}]",Games for health journal,['10.1089/g4h.2020.0086']
2929,33058746,Manual Lymphatic Drainage May Not Have an Additional Effect on the Intensive Phase of Breast Cancer-Related Lymphedema: A Randomized Controlled Trial.,"Background:  Breast cancer-related lymphedema (BCRL) is a potentially debilitating complication of breast cancer and its treatment. The aim of this study was to determine the efficacy of manual lymphatic drainage (MLD) added to multilayer compressive bandage treatment in addition to an exercise program, on arm volume, subjective symptoms, upper limb functions, and health-related quality of life (HRQoL) in patients with BCRL.  Methods:  This prospective, randomized, single-blind interventional trial involved 54 patients with BCRL. Eligible patients were randomly allocated to a complex decongestive therapy (CDT) group ( n  = 27) and a standard therapy (ST) group ( n  = 27). Both groups participated in a 15-session program (every weekday for 3 weeks) that included compressive multilayer bandaging and exercise training. The patients who were allocated to the CDT group received MLD before bandaging in addition to the ST. Bilateral arm circumferences were measured using a measuring tape at six reference points. Subjective symptoms, such as discomfort, heaviness, and swelling severity were measured using a visual analog scale (VAS). Upper limb functions and HRQoL were assessed using the Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) and Lymphedema Functioning, Disability, and Health Questionnaire (Lymph-ICF), respectively.  Results:  The excess arm volume, percent change of excess arm volume, Quick-DASH scores, and Lymph-ICF subscale scores significantly decreased ( p  < 0.001) in both treatment groups. However, there was no significant difference between the two groups ( p  > 0.05) in terms of changes in these outcomes. The VAS discomfort ( p  = 0.015) and VAS heaviness ( p  = 0.014) scores decreased significantly in the CDT group compared to the ST group.  Conclusion:  The study findings indicated that both treatment approaches were effective in patients with BRCL. However, no additional effect of MLD was found with regard to percent reduction in arm volume in the intensive treatment period of BRCL.",2020,The VAS discomfort ( p  = 0.015) and VAS heaviness ( p  = 0.014) scores decreased significantly in the CDT group compared to the ST group.  ,"['patients with BCRL', 'Eligible patients', 'patients with BRCL', 'Breast Cancer-Related Lymphedema', '54 patients with BCRL', 'Breast cancer-related lymphedema']","['standard therapy (ST', 'complex decongestive therapy (CDT', 'CDT', 'MLD', 'manual lymphatic drainage (MLD', '15-session program (every weekday for 3 weeks) that included compressive multilayer bandaging and exercise training']","['VAS heaviness', 'visual analog scale (VAS', 'Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) and Lymphedema Functioning, Disability, and Health Questionnaire (Lymph-ICF', 'Upper limb functions and HRQoL', 'VAS discomfort', 'Subjective symptoms, such as discomfort, heaviness, and swelling severity', 'excess arm volume, percent change of excess arm volume, Quick-DASH scores, and Lymph-ICF subscale scores', 'arm volume, subjective symptoms, upper limb functions, and health-related quality of life (HRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0054696', 'cui_str': 'Carbohydrate deficient transferrin'}, {'cui': 'C0023522', 'cui_str': 'Metachromatic leukodystrophy'}, {'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024202', 'cui_str': 'Lymph'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",54.0,0.0515813,The VAS discomfort ( p  = 0.015) and VAS heaviness ( p  = 0.014) scores decreased significantly in the CDT group compared to the ST group.  ,"[{'ForeName': 'Ekin Ilke', 'Initials': 'EI', 'LastName': 'Sen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul University Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Arman', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul University Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Mert', 'Initials': 'M', 'LastName': 'Zure', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul University Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Yavuz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul University Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Dilsad', 'Initials': 'D', 'LastName': 'Sindel', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul University Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Aydan', 'Initials': 'A', 'LastName': 'Oral', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul University Istanbul Faculty of Medicine, Istanbul, Turkey.'}]",Lymphatic research and biology,['10.1089/lrb.2020.0049']
2930,33058401,Improving parents' knowledge of early signs of paediatric eye disease: A double-blind randomised controlled trial.,"IMPORTANCE


Educating parents to recognize signs of eye disease and consult a healthcare professional is critical to timely diagnosis, intervention, and outcomes.
BACKGROUND


We evaluate the effectiveness of an eye-health information pamphlet on parents' level of concern and help-seeking intention should they hypothetically observe leukocoria or strabismus in their child.
DESIGN


Double-blind, randomised controlled trial conducted at a metropolitan antenatal outpatient clinic.
PARTICIPANTS


518 pregnant women were enrolled in the study.
METHODS


After completing a study-specific pre-test survey describing hypothetical clinical scenarios at baseline, participants were randomly assigned to receive a pamphlet on either paediatric eye health (intervention) or infant play (control). The post-test survey was sent by email two weeks after baseline.
MAIN OUTCOME MEASURES


A change in the parents' level of concern if they observed leukocoria or strabismus and a change in their help-seeking intention if they hypothetically observed leukocoria or strabismus in their child.
RESULTS


Of the 518 women, 382 (73.7%) completed the post-test survey. At follow-up, women who received the intervention were more likely to report a higher level of concern if they observed leukocoria (OR 1.711 [CI: 1.176-2.497] p=0.005]) and were less likely to delay help-seeking (OR 0.560 [CI 0.382-0.817] p =0.003). No change in the level of concern for strabismus was identified between the groups; however, at follow-up, women who received the intervention were less likely to delay help-seeking (OR 0.318 [CI 0.125-0.806] p=0.016).
CONCLUSION AND RELEVANCE


Providing parents with relevant, evidence-based information can significantly improve their knowledge and positively influence help-seeking intentions if leukocoria or strabismus are observed.",2020,"No change in the level of concern for strabismus was identified between the groups; however, at follow-up, women who received the intervention were less likely to delay help-seeking (OR 0.318 [CI 0.125-0.806] p=0.016).
","['Of the 518 women, 382 (73.7%) completed the post-test survey', '518 pregnant women were enrolled in the study', 'metropolitan antenatal outpatient clinic']","['eye-health information pamphlet', 'pamphlet on either paediatric eye health (intervention) or infant play (control']","['level of concern if they observed leukocoria', 'level of concern for strabismus', 'delay help-seeking']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517750', 'cui_str': '382'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0152458', 'cui_str': 'Leukocoria'}, {'cui': 'C0038379', 'cui_str': 'Strabismus'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}]",518.0,0.345538,"No change in the level of concern for strabismus was identified between the groups; however, at follow-up, women who received the intervention were less likely to delay help-seeking (OR 0.318 [CI 0.125-0.806] p=0.016).
","[{'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Staffieri', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Gwyneth', 'Initials': 'G', 'LastName': 'Rees', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Sanfilippo', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cole', 'Affiliation': ""Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Mackey', 'Affiliation': ""Lion's Eye Institute, Centre for Ophthalmology and Visual Sciences, University of Western Australia, Western Australia.""}, {'ForeName': 'Alex W', 'Initials': 'AW', 'LastName': 'Hewitt', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}]",Clinical & experimental ophthalmology,['10.1111/ceo.13866']
2931,33058419,Evaluation of pain intensity in patients treated with aligners and conventional fixed appliances: randomized clinical trial.,"OBJECTIVE


This randomized clinical trial aimed to compare the pain intensity in patients treated with orthodontic aligners and conventional fixed appliances.
SETTING AND SAMPLE POPULATION


This study was a randomized clinical trial. The sample comprised 39 patients randomly allocated into 2 groups: OA (orthodontic aligners, n=20) and FA (Fixed Appliance, n=19).
MATERIAL AND METHODS


The pain intensity was measured by the visual analogue scale (VAS) in the following periods: T0 (baseline), T1 (seven days after appliance placement), and seven days after each return on the first (T2), third (T3) and sixth (T4) months. The following variables were also investigated in the baseline: conditioned pain modulation, anxiety levels, hypervigilance and catastrophizing. The VAS measurements between groups were compared by the Mann-Whitney test. Comparisons between periods within each group were performed by the Friedman test. Data regarding catastrophizing and hypervigilance were compared by the t test. All tests were applied at a significance level of 5%, with 95% confidence interval.
RESULTS


Both groups presented similar levels of anxiety, hypervigilance, catastrophizing and conditioned pain modulation. Both groups did not differ concerning the pain intensity in all periods. The intragroup evaluation revealed statistical differences between days in the FA group at all moments evaluated, for the OA group, similar findings between days were found for the T1 evaluation, however, at the 6 months period (T4), the pain levels varied over these days without statistical difference. Higher levels of pain were observed in the first seven days after appliance placement.
CONCLUSION


The pain intensity, usually mild, was not influenced by the appliance design, although different patterns of reported pain seems to occur between groups.",2020,"The intragroup evaluation revealed statistical differences between days in the FA group at all moments evaluated, for the OA group, similar findings between days were found for the T1 evaluation, however, at the 6 months period (T4), the pain levels varied over these days without statistical difference.","['patients treated with aligners and conventional fixed appliances', 'patients treated with orthodontic aligners and conventional fixed appliances']","['OA (orthodontic aligners, n=20) and FA (Fixed Appliance, n=19']","['visual analogue scale (VAS', 'VAS measurements', 'pain modulation, anxiety levels, hypervigilance and catastrophizing', 'pain levels', 'Higher levels of pain', 'pain intensity', 'anxiety, hypervigilance, catastrophizing and conditioned pain modulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}]","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0235013', 'cui_str': 'Hypervigilance'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",39.0,0.140197,"The intragroup evaluation revealed statistical differences between days in the FA group at all moments evaluated, for the OA group, similar findings between days were found for the T1 evaluation, however, at the 6 months period (T4), the pain levels varied over these days without statistical difference.","[{'ForeName': 'Cleomária Evelyn Vieira Freire', 'Initials': 'CEVF', 'LastName': 'Casteluci', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina-PR, Brazil.'}, {'ForeName': 'Paula Vanessa Pedron', 'Initials': 'PVP', 'LastName': 'Oltramari', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina-PR, Brazil.'}, {'ForeName': 'Paulo César Rodrigues', 'Initials': 'PCR', 'LastName': 'Conti', 'Affiliation': 'Department of Prosthodontics, Bauru School of Dentistry, University of São Paulo, Brazil, Bauru Orofacial Pain Group.'}, {'ForeName': 'Leonardo Rigoldi', 'Initials': 'LR', 'LastName': 'Bonjardim', 'Affiliation': 'Section of Head and Face Physiology, Department of Biological Sciences, Bauru School of Dentistry, University of São Paulo, Brazil, Bauru Orofacial Pain Group.'}, {'ForeName': 'Renata Rodrigues', 'Initials': 'RR', 'LastName': 'de Almeida-Pedrin', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina-PR, Brazil.'}, {'ForeName': 'Thaís Maria Freire', 'Initials': 'TMF', 'LastName': 'Fernandes', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina-PR, Brazil.'}, {'ForeName': 'Marcio Rodrigues', 'Initials': 'MR', 'LastName': 'de Almeida', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina-PR, Brazil.'}, {'ForeName': 'Ana Cláudia', 'Initials': 'AC', 'LastName': 'de Castro Ferreira Conti', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina-PR, Brazil.'}]",Orthodontics & craniofacial research,['10.1111/ocr.12431']
2932,33058429,Mid-term follow-up of balloon pulmonary angioplasty for inoperable chronic thromboembolic pulmonary hypertension: An experience in Latin America.,"OBJECTIVES


To describe the characteristics of patients who undergo balloon pulmonary angioplasty (BPA) for inoperable chronic thromboembolic pulmonary hypertension (CTEPH) and report the mid-term outcomes.
BACKGROUND


BPA has been recently introduced in Latin America. Mid-term results have not been published.
METHODS


Prospective Chilean Registry of inoperable CTEPH patients who underwent BPA. Clinical variables were analyzed at baseline, after each procedure and at follow-up. Hemodynamic variables were recorded before and after the last BPA.
RESULTS


Between August 2016 and September 2019, 22 patients (17 women), 59 ± 12.7 years, underwent 81 BPA and were followed for as long as 33.1 months (mean 17.3 ± 7.5). Mean pulmonary artery pressure decreased by 17.4% (51.1 ± 12 vs. 42.2 ± 13 mmHg, p = .001), pulmonary vascular resistance by 23.9% (766.7 ± 351 vs. 583 ± 346 dynes/s/cm -5  , p = .001), cardiac index increased by 8% (2.3 ± 0.54 vs. 2.5 ± 0.54 L/min/m 2  , p = .012), N-terminal pro-B-type natriuretic peptide decreased by 73.8% (1,685 ± 1,045 vs. 441.8 ± 276 pg/dl, p = .006), and 6-min walk distance improved by 135 m (316.7 ± 94 vs. 451.1 ± 113 m, p = .001). One patient (4.5%) developed lung reperfusion injury and four patients (18.2%) had minor bleeding (hemoptysis), after the procedure. There was no mortality associated with BPA.
CONCLUSIONS


Our results confirm that BPA for inoperable CTEPH is a relatively safe procedure that improves clinical and hemodynamic parameters in the mid-term. This therapy should be considered as an alternative, mainly in places where access to PAH therapy or surgery is restricted.",2020,Our results confirm that BPA for inoperable CTEPH is a relatively safe procedure that improves clinical and hemodynamic parameters in the mid-term.,"['inoperable chronic thromboembolic pulmonary hypertension', '2019 patients (17 women), 59 ±\u200912.7\u2009years, underwent 81 BPA and were followed for as long as 33.1\u2009months (mean 17.3\u2009±\u20097.5', 'Prospective Chilean Registry of inoperable CTEPH patients who underwent BPA', 'patients who undergo', 'Between August 2016 and September 22']","['balloon pulmonary angioplasty', 'balloon pulmonary angioplasty (BPA']","['6-min walk distance', 'pulmonary vascular resistance', 'cardiac index', 'minor bleeding (hemoptysis', 'Mean pulmonary artery pressure', 'Hemodynamic variables', 'lung reperfusion injury', 'N-terminal pro-B-type natriuretic peptide']","[{'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C2363973', 'cui_str': 'Chronic thromboembolic pulmonary hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0019079', 'cui_str': 'Hemoptysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]",,0.0373397,Our results confirm that BPA for inoperable CTEPH is a relatively safe procedure that improves clinical and hemodynamic parameters in the mid-term.,"[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Sepúlveda', 'Affiliation': 'Division of Cardiovascular Diseases, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hameau', 'Affiliation': 'Division of Cardiovascular Diseases, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Backhouse', 'Affiliation': 'Pabellón de Hemodinamia, Hospital San Juan de Dios, Santiago, Chile.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Charme', 'Affiliation': 'Laboratorio de Hemodinamia, Hospital Naval, Viña del Mar, Chile.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Pacheco', 'Affiliation': 'Division of Cardiovascular Diseases, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Pablo A', 'Initials': 'PA', 'LastName': 'Ramírez', 'Affiliation': 'Pabellón de Hemodinamia, Hospital San Juan de Dios, Santiago, Chile.'}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Fuensalida', 'Affiliation': 'Division of Cardiovascular Diseases, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Quitral', 'Affiliation': 'Division of Cardiovascular Diseases, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Martínez', 'Affiliation': 'Division of Cardiovascular Diseases, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'Division of Cardiovascular Diseases, Pontificia Universidad Católica de Chile, Santiago, Chile.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29322']
2933,33058438,Neurofilament Results for the Phase II Neuroprotection Study of Phenytoin in Optic Neuritis.,"BACKGROUND


A randomized trial of phenytoin in acute optic neuritis (ON) demonstrated a 30% reduction in retinal nerve fiber layer (RNFL) loss with phenytoin versus placebo. Here we present the corresponding serum neurofilament analyses.
METHODS


Eighty-six acute ON cases were randomised to receive phenytoin (4-6 mg/kg/day) or placebo for 3 months, and followed up for 6 months. Serum was collected at baseline, 3, and 6 months for analysis of neurofilament heavy chain (NfH) and light chain (NfL).
RESULTS


Sixty-four had blood sampling. Of these, 58 and 56 were available at 3 months, and 55 and 54 were available at 6 months for NfH and NfL, respectively. There was no significant correlation between serum NfH and NfL at the time points tested. For NfH, the difference in mean placebo - phenytoin was -44 pg/ml at 3 months (p=0.019), and -27 pg/ml at 6 months (p=0.234). For NfL, the difference was 1.4 pg/ml at 3 months (p=0.726), and -1.6 pg/ml at 6 months (p=0.766).
CONCLUSIONS


At 3 months, there was a reduction in NfH, but not NFL in the phenytoin versus placebo group, while differences at 6 months were not statistically significant. This suggests a potential neuroprotective role for phenytoin in acute ON, with the lower NfH at 3 months, when levels secondary to degeneration of the anterior visual pathway are still elevated, but not at 6 months, when levels have normalized.",2020,"At 3 months, there was a reduction in NfH, but not NFL in the phenytoin versus placebo group, while differences at 6 months were not statistically significant.","['Sixty-four had blood sampling', 'Optic Neuritis', 'Eighty-six']","['placebo - phenytoin', 'placebo', 'Phenytoin', 'phenytoin versus placebo', 'phenytoin']","['acute', 'serum NfH and NfL']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0029134', 'cui_str': 'Optic neuritis'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031507', 'cui_str': 'Phenytoin'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0337112', 'cui_str': 'Chain'}]",,0.258728,"At 3 months, there was a reduction in NfH, but not NFL in the phenytoin versus placebo group, while differences at 6 months were not statistically significant.","[{'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Raftopoulos', 'Affiliation': 'University College London Institute of Neurology, UK.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kuhle', 'Affiliation': 'Department of Neurology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Grant', 'Affiliation': 'University College London Institute of Neurology, UK.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Hickman', 'Affiliation': 'Department of Neurology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Altmann', 'Affiliation': 'Medical Statistics Department, School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leppert', 'Affiliation': 'Department of Neurology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Kaj', 'Initials': 'K', 'LastName': 'Blennow', 'Affiliation': 'Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Zetterberg', 'Affiliation': 'Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Kapoor', 'Affiliation': 'University College London Institute of Neurology, UK.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Department of Neuroscience & Trauma, QMUL, London, UK.'}, {'ForeName': 'Sharmilee', 'Initials': 'S', 'LastName': 'Gnanapavan', 'Affiliation': 'Department of Neuroscience & Trauma, QMUL, London, UK.'}]",European journal of neurology,['10.1111/ene.14591']
2934,33058456,Network intervention analysis to assess the trajectory of change and treatment effects associated with the use of online guided self-help for anorexia nervosa.,"AIM


The aim of this study was to use the innovative technique of Network Intervention Analysis (NIA) to examine the trajectory of symptom change associated with the use of a digital guided self-help intervention (RecoveryMANTRA) to augment treatment as usual in adult anorexia nervosa.
METHODS


Self-reported eating disorder symptoms and mood (stress, anxiety and depression), work and social adjustment, motivation and treatment (Treatment as usual + RecoveryMANTRAand Treatment as usual) were included as nodes in the network and examined using NIA. Networks were computed at baseline (n = 88, 99), at end of treatment (6 weeks, n = 71, 75) and at 6- (n = 58, 63) and 12-month (n = 52, 63) follow-up.
RESULTS


RecoveryMANTRA was associated with a direct effect on anxiety, shape concern and restraint at the end of the intervention. This effect was not maintained at follow-up. There were no direct effects of RecoveryMANTRA on motivation, stress and depression.
CONCLUSIONS


These findings indicate that RecoveryMANTRA exerts a direct effect on eating disorder symptoms and anxiety. NIA is a promising method to evaluate trajectories of clinical change and direct and indirect effects of a therapeutic intervention compared to a control condition.",2020,"RESULTS


RecoveryMANTRA was associated with a direct effect on anxiety, shape concern and restraint at the end of the intervention.","['Self-reported eating disorder symptoms and mood (stress, anxiety and depression), work and social adjustment, motivation and treatment (Treatment as usual\u2009+\u2009RecoveryMANTRAand Treatment as usual) were included as nodes in the network and examined using NIA', 'anorexia nervosa', 'adult anorexia nervosa', '6- (n = 58, 63) and 12-month (n = 52, 63']","['RecoveryMANTRA', 'Network Intervention Analysis (NIA', 'digital guided self-help intervention (RecoveryMANTRA']","['eating disorder symptoms and anxiety', 'motivation, stress and depression']","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}]","[{'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0353687,"RESULTS


RecoveryMANTRA was associated with a direct effect on anxiety, shape concern and restraint at the end of the intervention.","[{'ForeName': 'Alessio Maria', 'Initials': 'AM', 'LastName': 'Monteleone', 'Affiliation': 'Department of Psychiatry, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Cardi', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Ambwani', 'Affiliation': 'Dickinson College, Carlisle, Pennsylvania, USA.'}, {'ForeName': 'Giammarco', 'Initials': 'G', 'LastName': 'Cascino', 'Affiliation': ""Department of Medicine, Surgery and Dentistry 'Scuola Medica Salernitana', Section of Neurosciences, University of Salerno, Salerno, Italy.""}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Albano', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pellegrino', 'Affiliation': 'Department of Psychiatry, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",Early intervention in psychiatry,['10.1111/eip.13064']
2935,33058473,Achieving high convective volume in hemodiafiltration: Lessons learned after successful implementation in the HDFit trial.,"BACKGROUND AND OBJECTIVES


High-volume online hemodiafiltration (OL-HDF) associates with improved outcomes compared to hemodialysis (HD), provided adequate dosing is achieved as estimated from convective volume (CV). Achievement of high CV and its impact on biochemical indicators following a standardized protocol converting HD patients to OL-HDF has not been systematically reported. We assessed the success of implementation of OL-HDF in clinics naïve to the modality.
DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS


We analyzed the results of the implementation of postdilution OL-HDF in patients randomized to the HDF arm of a clinical trial (impact of hemoDiaFIlTration on physical activity and self-reported outcomes: a randomized controlled trial (HDFit) trial [ClinicalTrials.gov:NCT02787161]). The day before randomization of the first patient to OL-HDF at each clinic staff started a 3-day in-person training module on operation of Fresenius 5008 CorDiax machine in HDF mode. Patients were converted from high-flux HD to OL-HDF under oversight of trainers. OL-HDF was performed over a 6-months follow-up with a CV target of 22 L/treatment. We characterized median achieved CV >22 L/treatment record and analyzed the impact of HDF on biochemical variables.
RESULTS


Ninety-seven patients (mean age 53 ± 16 years, 29% with diabetes, and 11% had a catheter) from 13 clinics randomized to the OL-HDF arm of the trial were converted from HD to HDF. Median CV > 22 L/treatment was achieved in 99% (94/95) of OL-HDF patients throughout follow-up. Monthly mean CV ranged from 27.1 L to 27.5 L. OL-HDF provided an increased single pool Kt/V at 3-months (0.2 [95% CI: 0.1-0.3]) and 6-months (0.2 [95% CI: 0.1-0.4]) compared to baseline, and reduced phosphate at 3-months (-0.4 mg/dL [95% CI: -0.8 to -0.12]) of follow-up.
CONCLUSIONS


High-volume online hemodiafiltration was successfully implemented with 99% of patients achieving protocol defined CV target. Monthly mean CV was consistently >22 L/treatment during follow-up. Kt/V increased, and phosphate decreased with OL-HDF. Findings resulting from a short training period in several dialysis facilities appear to suggest HDF is an easily implementable technique.",2020,Median CV > 22 L/treatment was achieved in 99% (94/95) of OL-HDF patients throughout follow-up.,"['Ninety-seven patients (mean age 53\u2009±\u200916\u2009years, 29% with diabetes, and 11% had a catheter) from 13 clinics randomized to the OL-HDF arm of the trial were converted from HD to HDF']","['hemoDiaFIlTration', 'High-volume online hemodiafiltration (OL-HDF']","['Median CV', 'Monthly mean CV']","[{'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",5008.0,0.054521,Median CV > 22 L/treatment was achieved in 99% (94/95) of OL-HDF patients throughout follow-up.,"[{'ForeName': 'Murilo', 'Initials': 'M', 'LastName': 'Guedes', 'Affiliation': 'School of Medicine, Pontificia Universidade Catolica do Parana, Curitiba, Brazil.'}, {'ForeName': 'Ana Claudia', 'Initials': 'AC', 'LastName': 'Dambiski', 'Affiliation': 'Irmandade da Santa Casa de Misericórdia de Curitiba, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Sinaia', 'Initials': 'S', 'LastName': 'Canhada', 'Affiliation': 'Fresenius Medical Care Brazil, Rio de Janeiro, Brazil.'}, {'ForeName': 'Ana Beatriz L', 'Initials': 'ABL', 'LastName': 'Barra', 'Affiliation': 'Fresenius Medical Care Brazil, Rio de Janeiro, Brazil.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Poli-de-Figueiredo', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Américo Lourenço', 'Initials': 'AL', 'LastName': 'Cuvello Neto', 'Affiliation': 'Hospital Alemão Oswaldo Cruz, São Paulo, Brazil.'}, {'ForeName': 'Maria Eugênia F', 'Initials': 'MEF', 'LastName': 'Canziani', 'Affiliation': 'Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jorge Paulo', 'Initials': 'JP', 'LastName': 'Strogoff-de-Matos', 'Affiliation': 'Clínica de Diálise Ingá, Rio de Janeiro, Brazil.'}, {'ForeName': 'Jochen G', 'Initials': 'JG', 'LastName': 'Raimann', 'Affiliation': 'Renal Research Institute, New York, New York, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'School of Medicine, Pontificia Universidade Catolica do Parana, Curitiba, Brazil.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Canaud', 'Affiliation': 'Fresenius Medical Care, Global Medical Office, Bad Homburg, Germany.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pecoits-Filho', 'Affiliation': 'School of Medicine, Pontificia Universidade Catolica do Parana, Curitiba, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12891']
2936,33058522,"Effective Lightening of Facial Melasma During the Summer with a Dual Regimen: A Prospective, Open-Label, Evaluator-Blinded Study.","BACKGROUND


Melasma is a chronic pigmentary condition that can have significant negative effects on quality of life. Vitamin C can be effective in the treatment melasma, but its delivery often proves to be challenging due to instability of the drug and subsequent cutaneous irritation at higher concentrations.
AIM


In this prospective, open-label, evaluator-blinded study we aimed to assess the efficacy and tolerability of twice daily application of a novel, highly potent, non-irritating 30% Tetrahexadecyl (THD) ascorbate serum in combination with 100% mineral-based sunscreen in the treatment of melasma during the summer months.
PATIENTS/METHODS


Ten female subjects of ages ranging from 18 to 60 years underwent twice daily application of 30% THD ascorbate serum in combination with an anti-aging 100% mineral tinted broad-spectrum protection SPF 45 sunscreen moisturizer for 12 weeks during the summer months (July to September). Two blinded evaluators scored baseline and post-treatment photos using the Griffiths' 10-point scale and global aesthetic improvement scale.
RESULTS


All subjects showed an improvement in hyperpigmentation with an average improvement of 33.7%. Seventy percent of subjects showed an improvement in skin tone evenness (redness) and among those subjects, the average improvement was 33.3%. The median global aesthetic improvement score was 2.0 (very much improved).
CONCLUSION


Our study demonstrated efficacy and safety in treating the pigmentary as well as vascular components of melasma with a novel 30% THD ascorbate serum and a purely mineral-based tinted moisturizing sunscreen.",2020,"Seventy percent of subjects showed an improvement in skin tone evenness (redness) and among those subjects, the average improvement was 33.3%.",['Ten female subjects of ages ranging from 18 to 60 years underwent'],"['twice daily application of 30% THD ascorbate serum in combination with an anti-aging 100% mineral tinted broad-spectrum protection SPF 45 sunscreen moisturizer', 'Vitamin C', 'novel, highly potent, non-irritating 30% Tetrahexadecyl (THD) ascorbate serum in combination with 100% mineral-based sunscreen']","[""Griffiths' 10-point scale and global aesthetic improvement scale"", 'efficacy and safety', 'hyperpigmentation', 'median global aesthetic improvement score', 'quality of life', 'efficacy and tolerability', 'skin tone evenness (redness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0812425', 'cui_str': 'Mitotic index'}, {'cui': 'C0038818', 'cui_str': 'Sunscreen agent'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037290', 'cui_str': 'Skin pigmentation'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",10.0,0.0188126,"Seventy percent of subjects showed an improvement in skin tone evenness (redness) and among those subjects, the average improvement was 33.3%.","[{'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Kelm', 'Affiliation': 'Department of Dermatology, Rush University, Chicago, Illinois, USA.'}, {'ForeName': 'Alisar S', 'Initials': 'AS', 'LastName': 'Zahr', 'Affiliation': 'Revision Skincare, Irving, Texas, USA.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Kononov', 'Affiliation': 'Revision Skincare, Irving, Texas, USA.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Ibrahim', 'Affiliation': 'Chicago Cosmetic Surgery and Dermatology, Chicago, Illinois, USA.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13787']
2937,33058884,Safety and efficacy of peroral endoscopic myotomy with standard myotomy versus short myotomy for treatment-naïve patients with type II achalasia: a prospective randomized trial.,"BACKGROUND AND AIMS


Peroral endoscopic myotomy (POEM) has surfaced as an effective endoscopic treatment modality for achalasia. However, there is no consensus regarding the length of muscle bundle dissection during POEM. The most commonly used approach is the standard myotomy (about 10 cm). We herein compared the outcomes between standard myotomy versus short myotomy for the management of treatment-naïve patients with type II achalasia.
METHODS


This was a prospective, single-center, randomized trial in China. Previously untreated adults with a clinical diagnosis of type II achalasia, confirmed by manometric testing, were enrolled between February 2018 and February 2019. Patients were randomly assigned to POEM with standard myotomy or short myotomy group. Clinical data about demographic characteristics, operative parameters, pre- and postoperative Eckardt score, esophageal manometry results, 24-hour pH test, and adverse events were recorded and compared between the 2 groups.
RESULTS


Of the 100 randomized patients, 94 underwent treatment (48 in the standard myotomy group and 46 in the short myotomy group) and 91 (97%) completed the study. POEM could be successfully accomplished in most of the patients (97.8%). The primary outcome of treatment success occurred in 45 of 48 patients (93.8%) in the standard group versus 44 of 46 (95.7%) in the short group, with no statistically significant difference between the 2 groups (P=0.520). There was no significant between-group difference in the postoperative esophageal manometry, Eckardt score, diameter of the esophageal lumen, quality of life, procedure-related adverse events or reflux esophagitis (P > 0.05). Postoperative abnormal esophageal acid exposure occurred more often in the standard group than in the short group (21 of 48 patients [43.8%] vs 11 of 46 patients [23.9%], P = 0.042). Meanwhile, the short group showed a significant reduction in total procedure time compared with the standard group (31.2±15.3 min vs 45.6±16.2 min, respectively, P <0.05).
CONCLUSIONS


Among treatment-naïve patients with type II achalasia, standard and short POEM were comparable in terms of providing treatment efficacy and improving quality of life at 1 year, whereas short POEM is technically simpler to perform and requires less procedure time. Moreover, the short POEM approach was resulted in fewer cases of postoperative abnormal esophageal acid exposure.",2020,"There was no significant between-group difference in the postoperative esophageal manometry, Eckardt score, diameter of the esophageal lumen, quality of life, procedure-related adverse events or reflux esophagitis (P > 0.05).","['Previously untreated adults with a clinical diagnosis of type II achalasia, confirmed by manometric testing, were enrolled between February 2018 and February 2019', 'treatment-naïve patients with type II achalasia', '100 randomized patients, 94 underwent treatment (48 in the standard myotomy group and 46 in the short myotomy group) and 91 (97%) completed the study']","['peroral endoscopic myotomy with standard myotomy versus short myotomy', 'POEM with standard myotomy or short myotomy group', 'Peroral endoscopic myotomy (POEM']","['Safety and efficacy', 'treatment success', 'Postoperative abnormal esophageal acid exposure', 'total procedure time', 'postoperative esophageal manometry, Eckardt score, diameter of the esophageal lumen, quality of life, procedure-related adverse events or reflux esophagitis', 'quality of life', 'pre- and postoperative Eckardt score, esophageal manometry results, 24-hour pH test, and adverse events', 'postoperative abnormal esophageal acid exposure']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0014848', 'cui_str': 'Achalasia of esophagus'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0185181', 'cui_str': 'Incision of muscle'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4760898', 'cui_str': 'Peroral endoscopic myotomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0185181', 'cui_str': 'Incision of muscle'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199873', 'cui_str': 'Esophageal manometry'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0227194', 'cui_str': 'Structure of esophageal lumen'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0014869', 'cui_str': 'Esophagitis, Reflux'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",100.0,0.093044,"There was no significant between-group difference in the postoperative esophageal manometry, Eckardt score, diameter of the esophageal lumen, quality of life, procedure-related adverse events or reflux esophagitis (P > 0.05).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Gu', 'Affiliation': 'Department of Gastroenterology, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, PR. China.'}, {'ForeName': 'Zhenghui', 'Initials': 'Z', 'LastName': 'Ouyang', 'Affiliation': 'Department of Gastroenterology, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, PR. China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': 'Department of Gastroenterology, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, PR. China.'}, {'ForeName': 'Chengbo', 'Initials': 'C', 'LastName': 'Liang', 'Affiliation': 'Department of Gastroenterology, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, PR. China.'}, {'ForeName': 'Hongyi', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastroenterology, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, PR. China.'}, {'ForeName': 'Deliang', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, PR. China. Electronic address: deliangliu@csu.edu.cn.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.10.006']
2938,33058886,Comparing a conventional and a spring-and-loop with clip traction method of endoscopic submucosal dissection for superficial gastric neoplasms: a randomized controlled trial (with videos).,"BACKGROUND AND AIMS


There are several traction methods that have sought to overcome the technical difficulties of endoscopic submucosal dissection (ESD). However, traction direction has remained limited in most of these methods, with lack of clarity about the optimal method and traction direction for gastric ESD. A spring-and-loop with clip (SLC) has been developed as a multidirectional traction device. Here we investigated whether SLC traction-assisted ESD (SLC-ESD) improved procedure-related outcomes compared with conventional ESD (C-ESD) among patients with superficial gastric neoplasms.
METHODS


This single-center randomized controlled trial included patients with superficial gastric neoplasms undergoing SLC-ESD or C-ESD between October 2018 and December 2019. Using the multidirectional traction function, we set traction vertical to the gastric wall for SLC-ESD. The primary outcome was the median procedure time for gastric ESD.
RESULTS


The SLC-ESD and C-ESD groups comprised 40 patients each, and all the enrolled patients underwent the assigned treatment. The median ESD procedure time was significantly shorter in the SLC-ESD group (29.1 minutes) than in the C-ESD group (52.6 minutes; P = 0.005). SLC had a mean attachment time of 1.82 minutes. En bloc resection was achieved without perforation in all the patients of both the groups.
CONCLUSIONS


Our findings suggest that SLC-ESD reduces gastric ESD procedure time without increasing the risk of perforation and that vertical direction to the gastric wall is the appropriate traction direction for gastric ESD. (Clinical trial registration number: UMIN 000034533.).",2020,The median ESD procedure time was significantly shorter in the SLC-ESD group (29.1 minutes) than in the C-ESD group (52.6 minutes; P = 0.005).,"['patients with superficial gastric neoplasms undergoing SLC-ESD or C-ESD between October 2018 and December 2019', 'patients with superficial gastric neoplasms', 'superficial gastric neoplasms']","['SLC traction-assisted ESD (SLC-ESD', 'conventional and a spring-and-loop with clip traction method of endoscopic submucosal dissection', 'SLC-ESD', 'A spring-and-loop with clip (SLC', 'SLC', 'conventional ESD (C-ESD']","['mean attachment time', 'median procedure time for gastric ESD', 'median ESD procedure time', 'gastric ESD procedure time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0038356', 'cui_str': 'Neoplasm of stomach'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}]","[{'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1562800', 'cui_str': 'Soft tissue traction technique'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}]",,0.06134,The median ESD procedure time was significantly shorter in the SLC-ESD group (29.1 minutes) than in the C-ESD group (52.6 minutes; P = 0.005).,"[{'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Nagata', 'Affiliation': 'Department of Endoscopy, Shonan Fujisawa Tokushukai Hospital. Electronic address: mitsuru10jp@yahoo.co.jp.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Fujikawa', 'Affiliation': 'Center for Digestive and Hepato-Biliary-Pancreatic disease, Shonan Fujisawa Tokushukai Hospital.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Munakata', 'Affiliation': 'Center for Digestive and Hepato-Biliary-Pancreatic disease, Shonan Fujisawa Tokushukai Hospital.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.09.049']
2939,33058901,Virtual and real-life ostracism and its impact on a subsequent acute stressor.,"While ostracism constitutes a social stressor with negative effects on physical and mental health, social inclusion seems to increase resilience. This may be true not only for face-to-face settings, but also for computer-mediated interactions. Hence, this study examined the differences between ostracism and social inclusion in real-life or Virtual Reality (VR) regarding self-reported stress, neuroendocrine and cardiovascular reactivity in a subsequent real-life socio-evaluative task. 84 females were randomly assigned to a 3 (agency: face-to-face/human controlled VR-avatar/computer VR-agent) x 2 (inclusion status: inclusion/exclusion) between-subject design using a Cyberball paradigm. Subsequently, they were exposed to a real-life Trier Social Stress Test (TSST). Results indicate that the experience of ostracism constitutes a threat to fundamental social needs independent of agency. Excluded participants showed cardiovascular reactivity during TSST; also face-to-face and avatar excluded individuals had elevated salivary cortisol levels. Included participants reported more perceived social support during Cyberball and showed a blunted cortisol response to the TSST. These results suggest that face-to-face and avatar-related ostracism provokes responses in the hypothalamic-pituitary-adrenal (HPA) axis and the sympathetic nervous system (SNS). Furthermore, they reveal that social inclusion may act as a stress-protector as it alters HPA- and SNS-related stress responsiveness to subsequent stressors.",2020,Excluded participants showed cardiovascular reactivity during TSST; also face-to-face and avatar excluded individuals had elevated salivary cortisol levels.,['84 females'],['3 (agency: face-to-face/human controlled VR-avatar/computer VR-agent) x 2 (inclusion status: inclusion/exclusion) between-subject design using a Cyberball paradigm'],"['cardiovascular reactivity', 'elevated salivary cortisol levels', 'perceived social support', 'blunted cortisol response']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",84.0,0.0106574,Excluded participants showed cardiovascular reactivity during TSST; also face-to-face and avatar excluded individuals had elevated salivary cortisol levels.,"[{'ForeName': 'Oswald D', 'Initials': 'OD', 'LastName': 'Kothgassner', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria; Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goreis', 'Affiliation': 'Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria; Outpatient Unit for Research, Teaching and Practice, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Glenk', 'Affiliation': 'Department of Comparative Medicine, Messerli Research Institute, University of Veterinary Medicine Vienna, Medical University Vienna and University, Vienna, Austria.'}, {'ForeName': 'Johanna Xenia', 'Initials': 'JX', 'LastName': 'Kafka', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Beutl', 'Affiliation': 'Working Group Entertainment Computing, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Kryspin-Exner', 'Affiliation': 'Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Hlavacs', 'Affiliation': 'Working Group Entertainment Computing, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Palme', 'Affiliation': 'Department of Biomedical Sciences, University of Veterinary Medicine, Vienna, Austria.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Felnhofer', 'Affiliation': 'Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria; Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: anna.felnhofer@meduniwien.ac.at.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113205']
2940,33058946,Unethical use of imiquimod as a comparator group in a randomized clinical trial of children with molluscum contagiosum.,,2020,,['children with molluscum contagiosum'],['imiquimod'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026393', 'cui_str': 'Molluscum contagiosum infection'}]","[{'cui': 'C0165032', 'cui_str': 'imiquimod'}]",[],,0.0852119,,"[{'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Katz', 'Affiliation': 'Kaiser Permanente, 1600 Owens St., 9th Floor, San Francisco, CA 94158. Electronic address: Kenneth.Katz@gmail.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.09.095']
2941,33058957,"Nutritional adequacy of very low- and high-carbohydrate, low saturated fat diets in adults with type 2 diabetes: a secondary analysis of a 2-year randomised controlled trial.","BACKGROUND


Growing evidence supports use of very low-carbohydrate (LC) diets for glycaemic control in type 2 diabetes. However, limited data on the micronutrient adequacy of LC diets exist.
OBJECTIVE


This study compared the long-term effects of a very low-carbohydrate, high unsaturated/low saturated fat (LC) diet to a high-carbohydrate, low-fat (HC) diet on micronutrient biomarkers in adults with obesity and type 2 diabetes.
METHODS


115 adults with type 2 diabetes (mean[SD]; BMI:34.6[4.3]kg/m 2 , age:58[7]yrs, HbA1c:7.3[1.1]%, 56[12]mmol/mol) were randomized to one of two planned, nutritionally-replete, energy-matched, hypocaloric diets (500-1000kcal/day deficit): (1) LC:14% energy carbohydrate, 28%protein, 58%fat[<10% saturated fat]) or (2) HC:53%carbohydrate, 17%protein, 30%fat [<10%saturated fat]) for 2 years. Nutritional biomarkers- folate, β-carotene, vitamin B12, D, E, copper, zinc, selenium, calcium, magnesium, sodium, potassium, iron, ferritin, transferrin and transferrin saturation were measured in fasting blood at baseline, 24, 52 and 104 weeks.
RESULTS


61 participants completed the study with similar dropouts in each group (P=0.40). For all biomarkers assessed, there were no differential response between groups overtime (P≥0.17 time x diet interaction). Mean vitamin and mineral levels remained within normal (laboratory-specific) reference ranges without any reported cases of clinical deficiencies.
CONCLUSION


In free-living individuals with type 2 diabetes, nutrition biomarkers within normal ranges at baseline did not change significantly after 2 years on a prescribed LC or HC diet. These results demonstrate the feasibility of delivering a nutritionally replete LC diet and the importance of considering nutritional factors in planning LC diets that have strong public health relevance to the dietary management of type 2 diabetes.",2020,"For all biomarkers assessed, there were no differential response between groups overtime (P≥0.17 time x diet interaction).","['115 adults with type 2 diabetes (mean[SD', 'type 2 diabetes', 'adults with obesity and type 2 diabetes', 'adults with type 2 diabetes', '61 participants completed the study with similar dropouts in each group (P=0.40']","['very low-carbohydrate, high unsaturated/low saturated fat (LC) diet to a high-carbohydrate, low-fat (HC) diet', 'nutritionally-replete, energy-matched, hypocaloric diets (500-1000kcal/day deficit): (1) LC:14% energy carbohydrate, 28%protein, 58%fat[<10% saturated fat]) or (2) HC:53%carbohydrate, 17%protein, 30%fat [<10%saturated fat', 'low-carbohydrate (LC) diets', 'very low- and high-carbohydrate, low saturated fat diets']","['Nutritional biomarkers- folate, β-carotene, vitamin B12, D, E, copper, zinc, selenium, calcium, magnesium, sodium, potassium, iron, ferritin, transferrin and transferrin saturation', 'Mean vitamin and mineral levels']","[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0522535', 'cui_str': 'Unsaturated'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0007269', 'cui_str': 'Carotene'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0040679', 'cui_str': 'Transferrin'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",115.0,0.0668126,"For all biomarkers assessed, there were no differential response between groups overtime (P≥0.17 time x diet interaction).","[{'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Tay', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation (CSIRO) - Health and Biosecurity, Adelaide, Australia; Discipline of Medicine, University of Adelaide, Adelaide, Australia; Singapore Institute of Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR), Singapore. Electronic address: jeannie_tay@sics.a-star.edu.sg.'}, {'ForeName': 'Campbell H', 'Initials': 'CH', 'LastName': 'Thompson', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Luscombe-Marsh', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation (CSIRO) - Health and Biosecurity, Adelaide, Australia.'}, {'ForeName': 'Manny', 'Initials': 'M', 'LastName': 'Noakes', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation (CSIRO) - Health and Biosecurity, Adelaide, Australia.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Buckley', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Wittert', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Grant D', 'Initials': 'GD', 'LastName': 'Brinkworth', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation (CSIRO) - Health and Biosecurity, Sydney, Australia.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108501']
2942,33059084,CT Image Analysis of Neuromuscular Electrical Stimulation in the Treatment of Knee Osteoarthritis with Different Radiological Characteristics Based on Iterative Reconstruction Algorithm.,"The paper uses CT image analysis of iterative reconstruction algorithm to understand the effect of neuromuscular electrical stimulation of quadriceps on motor function rehabilitation after total knee arthroplasty (TKR). 104 patients after TKR were divided into two groups according to the stratified and randomized method. The treatment group was 52 cases. The quadriceps femoris was stimulated by neuromuscular electrical stimulation, and the patients were required to actively extend their knees along with the current stimulation; In cutaneous nerve electrical stimulation mode, two sets of electrodes are placed on the knee pain points. At the same time, all patients participated in conventional rehabilitation treatment and were discharged from the hospital on average (14.89±3.65) days after treatment. The visual analogy scale (VAS), the range of motion of the knee joint, and the knee joint injury and osteoarthritis score scale (KOOS) were evaluated before discharge. The average interval between follow-ups after discharge was 9.5 months, and the American Knee Society Score (KSS) and KOOS scale were assessed during follow-up. Results: The VAS scores of the treatment group and control group at discharge were (18.11±9.66) and (16.13±4.25), and the active range of motion (AROM) of the knee joint was (103.21°±15.44°) and (99.21°±15.19°), respectively The limitation of active knee extension in the treatment group was (1.93°±3.47°), which was significantly smaller than that of the control group (6.26°±4.28°). Therefore, early after TKR surgery with neuromuscular electrical stimulation of the quadriceps muscle rehabilitation therapy, it helps to improve the function of the knee extension device and accelerate functional rehabilitation. At the same time, CT imaging studies have found that the changes in tibial subchondral bone plate and subchondral cancellous bone in patients with knee osteoarthritis are mainly due to the destruction of ultrastructural homeostasis. This change may be the cause of knee osteoarthritis. one.",2020,"The VAS scores of the treatment group and control group at discharge were (18.11±9.66) and (16.13±4.25), and the active range of motion (AROM) of the knee joint was (103.21°±15.44°) and (99.21°±15.19°), respectively The limitation of active knee extension in the treatment group was (1.93°±3.47°), which was significantly smaller than that of the control group (6.26°±4.28°).","['patients with knee osteoarthritis', 'total knee arthroplasty (TKR', '104 patients after TKR', 'Knee Osteoarthritis with Different Radiological Characteristics']","['conventional rehabilitation treatment', 'TKR surgery with neuromuscular electrical stimulation of the quadriceps muscle rehabilitation therapy', 'Neuromuscular Electrical Stimulation']","['active range of motion (AROM) of the knee joint', 'VAS scores', 'visual analogy scale (VAS), the range of motion of the knee joint, and the knee joint injury and osteoarthritis score scale (KOOS', 'limitation of active knee extension', 'American Knee Society Score (KSS) and KOOS scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]",104.0,0.0239004,"The VAS scores of the treatment group and control group at discharge were (18.11±9.66) and (16.13±4.25), and the active range of motion (AROM) of the knee joint was (103.21°±15.44°) and (99.21°±15.19°), respectively The limitation of active knee extension in the treatment group was (1.93°±3.47°), which was significantly smaller than that of the control group (6.26°±4.28°).","[{'ForeName': 'Weijin', 'Initials': 'W', 'LastName': 'Xing', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Hainan Medical University, Haikou, 570311, China.'}, {'ForeName': 'Mubin', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Hainan Medical University, Haikou, 570311, China.'}, {'ForeName': 'Chuanzi', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Hainan Medical University, Haikou, 570311, China.'}, {'ForeName': 'Zhongshi', 'Initials': 'Z', 'LastName': 'Nie', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Hainan Medical University, Haikou, 570311, China.'}, {'ForeName': 'Wencai', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Hainan Medical University, Haikou, 570311, China. Electronic address: tangwencai_hkhmu@126.com.'}]",World neurosurgery,['10.1016/j.wneu.2020.10.032']
2943,33059096,Local vibration training improves the recovery of quadriceps strength in early rehabilitation after anterior cruciate ligament reconstruction: a feasibility randomized controlled trial.,"BACKGROUND


After anterior cruciate ligament reconstruction (ACLR), quadriceps strength must be maximized as early as possible.
OBJECTIVES


We tested whether local vibration training (LVT) during the early post-ACLR period (i.e., ∼10 weeks) could improve strength recovery.
METHODS


This was a multicentric, open, parallel-group, randomized controlled trial. Thirty individuals attending ACLR were randomized by use of a dedicated Web application to 2 groups: vibration (standardized rehabilitation plus LVT, n=16) or control (standardized rehabilitation alone, n=14). Experimenters, physiotherapists and participants were not blinded. Both groups received 24 sessions of standardized rehabilitation over ∼10 weeks. In addition, the vibration group received 1 hr of vibration applied to the relaxed quadriceps of the injured leg at the end of each rehabilitation session. The primary outcome - maximal isometric strength of both injured and non-injured legs (i.e., allowing for limb asymmetry measurement) - was evaluated before ACLR (PRE) and after the 10-week rehabilitation (POST).
RESULTS


Seven participants were lost to follow-up, so data for 23 participants were used in the complete-case analysis. For the injured leg, the mean (SD) decrease in maximal strength from PRE to POST was significantly lower for the vibration than control group (n=11, -16% [10] vs n=12, -30% [11]; p=0.0045, Cohen's d effect size = 1.33). Mean PRE-POST change in limb symmetry was lower for the vibration than control group (-19% [11] vs -29% [13]) but not significantly (p=0.051, Cohen's d effect size = 0.85).
CONCLUSION


LVT improved strength recovery after ACLR. This feasibility study suggests that LVT applied to relaxed muscles is a promising modality of vibration therapy that could be implemented early in ACLR.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02929004.",2020,"Mean PRE-POST change in limb symmetry was lower for the vibration than control group (-19% [11] vs -29% [13]) but not significantly (p=0.051, Cohen's d effect size = 0.85).
","['Thirty individuals attending ACLR', 'early rehabilitation after anterior cruciate ligament reconstruction']","['vibration (standardized rehabilitation plus LVT, n=16) or control (standardized rehabilitation alone', 'LVT', 'local vibration training (LVT', 'Local vibration training', 'anterior cruciate ligament reconstruction (ACLR']","['quadriceps strength', 'strength recovery', 'Mean PRE-POST change in limb symmetry', 'maximal isometric strength of both injured and non-injured legs (i.e., allowing for limb asymmetry measurement) - was evaluated before ACLR (PRE) and after the 10-week rehabilitation (POST', 'maximal strength from PRE to POST']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C2938981', 'cui_str': 'Limb asymmetry'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]",30.0,0.105921,"Mean PRE-POST change in limb symmetry was lower for the vibration than control group (-19% [11] vs -29% [13]) but not significantly (p=0.051, Cohen's d effect size = 0.85).
","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Coulondre', 'Affiliation': ""Inter-university Laboratory of Human Movement Biology (LIBM), University of Savoie Mont Blanc, EA 7424, 73000 Chambéry, France; Centre d'Evaluation et de Prévention ARTicualire (CEPART), 73490, Challes-les-Eaux, France; Centre d'Orthopédie et de Traumatologie du Sport, 73000, Bassens, France.""}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Souron', 'Affiliation': 'Univ Lyon, UJM-Saint-Etienne, Inter-university Laboratory of Human Movement Biology, EA 7424, F-42023, Saint-Etienne, France; Laboratory of Impact of Physical Activity on Health (IAPS), UR n°201723207F, University of Toulon, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Rambaud', 'Affiliation': 'Univ Lyon, UJM-Saint-Etienne, Inter-university Laboratory of Human Movement Biology, EA 7424, F-42023, Saint-Etienne, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Dalmais', 'Affiliation': ""Inter-university Laboratory of Human Movement Biology (LIBM), University of Savoie Mont Blanc, EA 7424, 73000 Chambéry, France; Centre d'Evaluation et de Prévention ARTicualire (CEPART), 73490, Challes-les-Eaux, France; Centre d'Orthopédie et de Traumatologie du Sport, 73000, Bassens, France.""}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Espeit', 'Affiliation': 'Univ Lyon, UJM-Saint-Etienne, Inter-university Laboratory of Human Movement Biology, EA 7424, F-42023, Saint-Etienne, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Neri', 'Affiliation': 'Univ Lyon, UJM-Saint-Etienne, Inter-university Laboratory of Human Movement Biology, EA 7424, F-42023, Saint-Etienne, France; Department of Orthopaedic Surgery, University Hospital of Saint Etienne, Faculty of medicine, Saint-Etienne, France.'}, {'ForeName': 'Alban', 'Initials': 'A', 'LastName': 'Pinaroli', 'Affiliation': 'Médipôle de Savoie, 73190, Challes-les-Eaux, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Estour', 'Affiliation': 'Médipôle de Savoie, 73190, Challes-les-Eaux, France.'}, {'ForeName': 'Guillaume Y', 'Initials': 'GY', 'LastName': 'Millet', 'Affiliation': 'Univ Lyon, UJM-Saint-Etienne, Inter-university Laboratory of Human Movement Biology, EA 7424, F-42023, Saint-Etienne, France; Institut Universitaire de France (IUF), France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rupp', 'Affiliation': 'Inter-university Laboratory of Human Movement Biology (LIBM), University of Savoie Mont Blanc, EA 7424, 73000 Chambéry, France.'}, {'ForeName': 'Léonard', 'Initials': 'L', 'LastName': 'Feasson', 'Affiliation': 'Univ Lyon, UJM-Saint-Etienne, Inter-university Laboratory of Human Movement Biology, EA 7424, F-42023, Saint-Etienne, France; Department of Clinical and Exercise Physiology, Sports Medicine and Myology Units, Regional Institute of Medicine and Sports Engineering (IRMIS), University Hospital of Saint-Etienne, Faculty of medicine, Saint-Etienne, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Edouard', 'Affiliation': 'Univ Lyon, UJM-Saint-Etienne, Inter-university Laboratory of Human Movement Biology, EA 7424, F-42023, Saint-Etienne, France; Department of Clinical and Exercise Physiology, Sports Medicine and Myology Units, Regional Institute of Medicine and Sports Engineering (IRMIS), University Hospital of Saint-Etienne, Faculty of medicine, Saint-Etienne, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lapole', 'Affiliation': 'Univ Lyon, UJM-Saint-Etienne, Inter-university Laboratory of Human Movement Biology, EA 7424, F-42023, Saint-Etienne, France. Electronic address: thomas.lapole@univ-st-etienne.fr.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.08.005']
2944,33059105,Topical use of tranexamic acid versus epinephrine to optimise surgical field during exploratory tympanotomy.,"OBJECTIVE


To explore the effect of diluting Tranexamic acid as 1000 mg versus epinephrine as 1 mg in a volume of 200 mL of normal saline used for local washing and rinsing of the used gauze at the surgical bleeding sites during microscopic ear surgeries.
METHODS


In a randomised, double-blind trial, sixty patients scheduled for elective microscopic exploratory tympanotomy consented to participate after meeting the inclusion criteria. Patients assigned using the balanced block randomisation method into two similar groups; one received Tranexamic acid (TXA), and the other received epinephrine. The outcome of the study focused on blood pressure, heart rate, quality of surgical field assessed via Boezaart score, the volume of bleeding, and the incidence of complications.
RESULTS


The more prominent findings were the statistically significant and favourable surgical field assessment according to the Boezaart score, and lower estimates of bleeding demonstrated in the TXA group compared to the epinephrine group, along the time of the study P-value was < 0.05. The haemodynamic monitoring showed promising changes in the TXA group compared with the epinephrine group in terms of lower mean blood pressure and lower heart rate that reached the level of statistical significance during the time of the study.
CONCLUSION


the use of topical Tranexamic acid during microscopic ear surgeries is associated with a better surgical field, less bleeding, and favourable haemodynamic parameters compared to epinephrine.",2020,"the use of topical Tranexamic acid during microscopic ear surgeries is associated with a better surgical field, less bleeding, and favourable haemodynamic parameters compared to epinephrine.",['sixty patients scheduled for elective microscopic exploratory tympanotomy consented to participate after meeting the inclusion criteria'],"['epinephrine', 'Tranexamic acid (TXA', 'diluting Tranexamic acid', 'tranexamic acid versus epinephrine', 'topical Tranexamic acid', 'TXA']","['mean blood pressure and lower heart rate', 'bleeding', 'blood pressure, heart rate, quality of surgical field assessed via Boezaart score, the volume of bleeding, and the incidence of complications']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0087123', 'cui_str': 'Tympanostomy'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",60.0,0.0997517,"the use of topical Tranexamic acid during microscopic ear surgeries is associated with a better surgical field, less bleeding, and favourable haemodynamic parameters compared to epinephrine.","[{'ForeName': 'Rasha A', 'Initials': 'RA', 'LastName': 'Hamed', 'Affiliation': 'Anaesthesiology Department, Faculty of Medicine, Assiut University, Assiut, Egypt. Electronic address: rashaahmed11@yahoo.com.'}, {'ForeName': 'Esam M', 'Initials': 'EM', 'LastName': 'Hamed', 'Affiliation': 'Lecturer of Anaesthesia, ICU and Pain Management, Assiut University, Assiut, Egypt.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2020.08.008']
2945,33059293,"A novel diclofenac gel (AMZ001) applied once or twice daily in subjects with painful knee osteoarthritis: A randomized, placebo-controlled clinical trial.","PURPOSE


Osteoarthritis Research Society International (OARSI) Expert Consensus Guidelines recommend topical non-steroidal anti-inflammatory drugs as first-line medications for osteoarthritis (OA) knee pain, but several voluminous daily applications are required to achieve efficacy. There is a need to develop new and improved topical analgesics with a faster onset, longer duration of action, and the requirement to apply less gel. This trial investigated the safety and efficacy of a new 3.06% diclofenac gel (AMZ001) in subjects with knee OA.
METHODS


In total, 444 subjects (AMZ001 twice daily (BID) [n = 121], AMZ001 once daily (QD) + placebo QD [n = 121], placebo BID [n = 121], or Voltaren 1% 4-times daily [n = 81]) were enrolled. All except Voltaren 1% (single-blinded) were applied topically in a double-blind manner for a total of 4-weeks. The primary endpoint was the change from baseline to week 4 in the WOMAC pain sub-score in the target knee. Secondary and exploratory endpoints included additional efficacy measures (WOMAC total score, WOMAC function and stiffness sub-scores, WOMAC pain weight-bearing and non-weight-bearing sub-scores, ICOAP, chair-stand test, OMERACT-OARSI responder rate, PGA, WPAI, EQ-5D, rescue medication use, satisfaction questionnaire) and safety.
RESULTS


Treatment with AMZ001 QD was effective at reducing WOMAC pain sub-scores vs placebo (estimated treatment difference [ETD]: -4.61 [95% confidence interval (CI): -9.09, -0.12]; p = 0.0440); however, BID application was not (ETD: -3.76 [95% CI: -8.21, 0.68]; p = 0.0969). For several secondary endpoints, changes from baseline to week 4 conferred nominally statistically significant improvements in favor of AMZ001 vs placebo, including PGA score (AMZ001 BID vs placebo, ETD: -0.61 [95% CI: -1.11, -0.11]; p = 0.0162; AMZ001 QD vs placebo, ETD: -0.63 [95% CI: -1.13, -0.13]; p = 0.0134), WPAI overall work impairment score (AMZ001 QD vs placebo, ETD: -10.44 [95% CI: -20.84, -0.04]; p = 0.0492), and EQ-5D VAS score (AMZ001 BID vs placebo, ETD: 4.70 [95% CI: 0.55, 8.85]; p = 0.0264). Post-hoc analysis excluding 11-14 subjects per group with pain scores that decreased between screening and baseline suggests a consistent effect of both AMZ001 QD (ETD: -5.84 [95% CI: -10.71, -0.97]; p = 0.0189) and BID (ETD: -5.35 [95% CI: -10.16, -0.54]; p = 0.0292) in reducing WOMAC pain sub-scores vs placebo. In general, treatment satisfaction was high, as measured by the satisfaction questionnaire. The frequency and incidence of adverse events (AEs) was greatest in the placebo group. Most AEs (>99%) were of mild or moderate severity. There were no serious AEs. There were no notable effects of any treatment on vital signs, ECGs, physical examination findings, or other laboratory assessments.
CONCLUSIONS


Treatment with AMZ001 BID for 4 weeks improved WOMAC pain sub-scores; however, only QD application conferred nominally statistically significant improvements vs placebo. AMZ001 was generally well tolerated.",2020,"There were no notable effects of any treatment on vital signs, ECGs, physical examination findings, or other laboratory assessments.
","['subjects with knee OA', 'subjects with painful knee osteoarthritis']","['placebo BID [n\xa0=\xa0121], or Voltaren 1% 4-times daily [n\xa0=\xa081', 'AMZ001 once daily (QD)\xa0+\xa0placebo QD', 'placebo, ETD', 'placebo', 'diclofenac gel (AMZ001', 'AMZ001 BID', 'AMZ001 QD', 'AMZ001 QD (ETD']","['PGA score', 'additional efficacy measures (WOMAC total score, WOMAC function and stiffness sub-scores, WOMAC pain weight-bearing and non-weight-bearing sub-scores, ICOAP, chair-stand test, OMERACT-OARSI responder rate, PGA, WPAI, EQ-5D, rescue medication use, satisfaction questionnaire) and safety', 'WOMAC pain sub-scores', 'safety and efficacy', 'EQ-5D VAS score', 'frequency and incidence of adverse events (AEs', 'WPAI overall work impairment score', 'vital signs, ECGs, physical examination findings, or other laboratory assessments', 'WOMAC pain sub-score', 'tolerated', 'pain scores']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0699958', 'cui_str': 'Voltaren'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",444.0,0.649854,"There were no notable effects of any treatment on vital signs, ECGs, physical examination findings, or other laboratory assessments.
","[{'ForeName': 'Asger Reinstrup', 'Initials': 'AR', 'LastName': 'Bihlet', 'Affiliation': 'Nordic Bioscience Clinical Development, Denmark. Electronic address: abi@nordicbio.com.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Byrjalsen', 'Affiliation': 'Nordic Bioscience Clinical Development, Denmark.'}, {'ForeName': 'Lee S', 'Initials': 'LS', 'LastName': 'Simon', 'Affiliation': 'SDG LLC, Cambridge, Massachusetts, United States.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Carrara', 'Affiliation': 'Amzell B.V., Hoofddorp, the Netherlands.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Delpy', 'Affiliation': 'Amzell B.V., Hoofddorp, the Netherlands.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Derne', 'Affiliation': 'Amzell B.V., Hoofddorp, the Netherlands.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.09.007']
2946,33059317,How to introduce a rotigotine patch to Parkinson's disease patients taking oral dopamine agonists.,"OBJECTIVE


Ways of introducing a rotigotine patch to Parkinson disease (PD) patients include initial induction for dopamine agonist (DA)-free patients and overnight switch (OS), cross-titration (CT), and add-on (AO) for patients already taking oral DAs. We investigated whether or not the introductions method affects the continuation rate of rotigotine patch.
METHODS


The subjects were 188 PD patients who started using a rotigotine patch at the Department of Neurology, Fukuoka University Hospital. The rate of successful continuation of rotigotine patch for one year after initiation and the reasons for discontinuation were investigated; for the patients who discontinued due to poor efficacy, the DA dose before and after the start of rotigotine patch treatment was determined.
RESULTS


The 1-year continuation rates were 38.5 % (20/52) in the OS group, 61.5 % (8/13) in the CT group, 35.3 % (6/17) in the AO group, and 50.9 % (54/106) in the de novo group. The most common reason for discontinuation in all groups was skin reactions. Compared with the de novo group, only the OS group had a significantly higher discontinuation rate due to poor efficacy (3.8 % vs. 21.2 %, P <  0.001). However, in the OS group, the continuation rate in the subjects with an increased total DA dose, after rotigotine was introduced, was significantly higher than that in the subjects with a decreased total DA dose (p = 0.031).
CONCLUSION


The use of a rotigotine patch with an equivalent dose should be considered when switching from oral DAs, and appropriate care should be administered for any skin reactions. The present findings suggested that not the introduction method but the use of an equivalent dose between DA formulations might affect the continuation rate of rotigotine patch.",2020,"The 1-year continuation rates were 38.5 % (20/52) in the OS group, 61.5 % (8/13) in the CT group, 35.3 % (6/17) in the AO group, and 50.9 % (54/106) in the de novo group.","['patients already taking oral DAs', '188 PD patients who started using a rotigotine patch at the Department of Neurology, Fukuoka University Hospital', ""Parkinson's disease patients taking oral dopamine agonists""]","['dopamine agonist (DA)-free patients and overnight switch (OS), cross-titration (CT', 'rotigotine patch']","['continuation rate of rotigotine patch', 'rate of successful continuation of rotigotine patch', 'continuation rate', 'discontinuation rate', '1-year continuation rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}]","[{'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0439234', 'cui_str': 'year'}]",188.0,0.0281234,"The 1-year continuation rates were 38.5 % (20/52) in the OS group, 61.5 % (8/13) in the CT group, 35.3 % (6/17) in the AO group, and 50.9 % (54/106) in the de novo group.","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yasutaka', 'Affiliation': 'Department of Pharmaceutical and Health Care Management, Faculty of Pharmaceutical Science, Fukuoka University, Japan; Department of Hospital Pharmacy, Fukuoka University Hospital, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Fujioka', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Fukuoka University, Japan. Electronic address: shinsuke@cis.fukuoka-u.ac.jp.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Mishima', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Fukuoka University, Japan.'}, {'ForeName': 'Hirotomo', 'Initials': 'H', 'LastName': 'Shibaguchi', 'Affiliation': 'Department of Hospital Pharmacy, Fukuoka University Hospital, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Fukuoka University, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Kamimura', 'Affiliation': 'Department of Pharmaceutical and Health Care Management, Faculty of Pharmaceutical Science, Fukuoka University, Japan; Department of Hospital Pharmacy, Fukuoka University Hospital, Japan.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106266']
2947,33059356,Acute dose-dependent effects of lysergic acid diethylamide in a double-blind placebo-controlled study in healthy subjects.,"Growing interest has been seen in using lysergic acid diethylamide (LSD) in psychiatric research and therapy. However, no modern studies have evaluated subjective and autonomic effects of different and pharmaceutically well-defined doses of LSD. We used a double-blind, randomized, placebo-controlled, crossover design in 16 healthy subjects (eight women, eight men) who underwent six 25 h sessions and received placebo, LSD (25, 50, 100, and 200 µg), and 200 µg LSD 1 h after administration of the serotonin 5-hydroxytryptamine-2A (5-HT 2A ) receptor antagonist ketanserin (40 mg). Test days were separated by at least 10 days. Outcome measures included self-rating scales that evaluated subjective effects, autonomic effects, adverse effects, plasma brain-derived neurotrophic factor levels, and pharmacokinetics up to 24 h. The pharmacokinetic-subjective response relationship was evaluated. LSD showed dose-proportional pharmacokinetics and first-order elimination and dose-dependently induced subjective responses starting at the 25 µg dose. A ceiling effect was observed for good drug effects at 100 µg. The 200 µg dose of LSD induced greater ego dissolution than the 100 µg dose and induced significant anxiety. The average duration of subjective effects increased from 6.7 to 11 h with increasing doses of 25-200 µg. LSD moderately increased blood pressure and heart rate. Ketanserin effectively prevented the response to 200 µg LSD. The LSD dose-response curve showed a ceiling effect for subjective good effects, and ego dissolution and anxiety increased further at a dose above 100 µg. These results may assist with dose finding for future LSD research. The full psychedelic effects of LSD are primarily mediated by serotonin 5-HT 2A  receptor activation.",2020,The 200 µg dose of LSD induced greater ego dissolution than the 100 µg dose and induced significant anxiety.,"['25, 50, 100, and 200\u2009µg), and 200\u2009µg LSD 1\u2009h after administration of the', '16 healthy subjects (eight women, eight men) who underwent six 25\u2009h sessions and received', 'healthy subjects']","['lysergic acid diethylamide', 'placebo, LSD', 'serotonin 5-hydroxytryptamine-2A (5-HT 2A ) receptor antagonist ketanserin', 'placebo', 'Ketanserin', 'LSD']","['blood pressure and heart rate', 'self-rating scales that evaluated subjective effects, autonomic effects, adverse effects, plasma brain-derived neurotrophic factor levels, and pharmacokinetics up to 24\u2009h', 'ego dissolution', 'average duration of subjective effects', 'ego dissolution and anxiety']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0022616', 'cui_str': 'Ketanserin'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C3179340', 'cui_str': 'Autonomic Effects'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0013712', 'cui_str': 'Ego'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",16.0,0.193,The 200 µg dose of LSD induced greater ego dissolution than the 100 µg dose and induced significant anxiety.,"[{'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holze', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Clinical Pharmacology and Toxicology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vizeli', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Clinical Pharmacology and Toxicology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ley', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Clinical Pharmacology and Toxicology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Psychiatric University Hospital, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dolder', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Clinical Pharmacology and Toxicology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Stocker', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Clinical Pharmacology and Toxicology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Duthaler', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Clinical Pharmacology and Toxicology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Nimmy', 'Initials': 'N', 'LastName': 'Varghese', 'Affiliation': 'Psychiatric University Hospital, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Eckert', 'Affiliation': 'Psychiatric University Hospital, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Borgwardt', 'Affiliation': 'Psychiatric University Hospital, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Clinical Pharmacology and Toxicology, University Hospital Basel, Basel, Switzerland. matthias.liechti@usb.ch.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00883-6']
2948,33059380,Postoperative Behaviour after Primary Strabismus Surgery in Children: Is There an Influence of Intraoperative Topical Anaesthesia?,"INTRODUCTION


The course of the recovery phase after general anaesthesia, during which consciousness and pain gradually return, is essentially determined by the choice of anaesthetic drug, and its total dose or duration of application. This phase is often complicated by more or less severe agitation, especially in children. In the present study we investigated whether the application of a topical anaesthetic to the conjunctiva at the end of a strabismus operation had a positive effect on the recovery behaviour of the child.
PATIENTS/METHODS


This prospective, randomised, blinded study was conducted with 50 healthy, ASA class I or II children, aged 3 to 8 years undergoing their first strabismus operation. Following the surgeon's randomisation two drops of a 0,5% tetracaine-HCl ophthalmic solution were applied to the operated conjunctiva three times at 30-s intervals immediately following wound closure. The postoperative evaluation encompassed heart rate, as well as COMFORT and CHEOPS scores. The first assessment was directly postoperatively with repetitions at 15, 30, 45, 60, 75, 90 and 120 min, as well as on the day after surgery.
RESULTS


The CHEOPS scores did not differ significantly between children with or without topical anaesthesia at any time during the observation period. The COMFORT scores revealed a slight, but non-significant analgesic effect at 15 and 30 min. The 60 min score showed the opposite effect, possibly indicating a slight disadvantage of the topical anaesthesia. There were no significant differences with regard to time to first request for additional systemic analgesia, to the total dose of systemic pain medication, or to when the patient was eligible for discharge to the ward.
CONCLUSION


The application of topical tetracaine-HCl immediately after wound closure had no positive effects on the course of the postoperative recovery period after strabismus surgery in children. There was no evidence of an effect on pain or emergence agitation.",2020,"There were no significant differences with regard to time to first request for additional systemic analgesia, to the total dose of systemic pain medication, or to when the patient was eligible for discharge to the ward.
","['children', 'Children', '50 healthy, ASA class I or II children, aged 3 to 8 years undergoing their first strabismus operation']","['tetracaine-HCl ophthalmic solution', 'topical tetracaine-HCl']","['pain or emergence agitation', 'CHEOPS scores', 'heart rate, as well as COMFORT and CHEOPS scores', 'time to first request for additional systemic analgesia', 'Postoperative Behaviour', 'COMFORT scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0197981', 'cui_str': 'Strabismus surgery'}]","[{'cui': 'C0304456', 'cui_str': 'Tetracaine hydrochloride'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.103423,"There were no significant differences with regard to time to first request for additional systemic analgesia, to the total dose of systemic pain medication, or to when the patient was eligible for discharge to the ward.
","[{'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Karstädt', 'Affiliation': 'Abteilung Augenheilkunde, Bereich Strabologie, Neuroophthalmologie und okuloplastische Chirurgie, Universitätsmedizin Göttingen, Deutschland.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Crozier', 'Affiliation': 'Klinik für Anästhesiologie, Universitätsmedizin Göttingen, Deutschland.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Horn', 'Affiliation': 'Abteilung Augenheilkunde, Bereich Strabologie, Neuroophthalmologie und okuloplastische Chirurgie, Universitätsmedizin Göttingen, Deutschland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Naxer', 'Affiliation': 'Abteilung Augenheilkunde, Bereich Strabologie, Neuroophthalmologie und okuloplastische Chirurgie, Universitätsmedizin Göttingen, Deutschland.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Schittkowski', 'Affiliation': 'Abteilung Augenheilkunde, Bereich Strabologie, Neuroophthalmologie und okuloplastische Chirurgie, Universitätsmedizin Göttingen, Deutschland.'}]",Klinische Monatsblatter fur Augenheilkunde,['10.1055/a-1260-3023']
2949,33059420,[Preliminary observation on the treatment of primary pterygium with modified conjunctival transplantation and amniotic membrane transplantation combined with use of interferon eye drops].,"Objective:  To observe the clinical effect of modified conjunctival transplantation and amniotic membrane transplantation combined with use of interferon (IFN) alpha-2b eye drops in the treatment of primary pterygium.  Methods:  This was a prospective case-control study. Patients with primary pterygium were treated from June 1, 2018 to December 31, 2018 in the Department of Ophthalmology, Beijing Tongren Hospital, and they were divided into two groups (the experimental group and the control group) by the method of randomized block design. Patients in the experimental group received modified conjunctival transplantation and amniotic membrane transplantation combined with use of IFN alpha-2b eye drops, while patients in the control group received pterygium resection combined with conjunctival autograft transplantation. The pterygium type and size were observed before operation, while visual acuity, intraocular pressure and anterior segment details were recorded either. The follow-up was done at 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after operation. The visual acuity, corneal epithelial defect, and pterygium recurrence were observed. All data in this manuscript are enumeration data, the expected frequency of pterygium type distribution in the two groups was more than 5, and the chi square test was used, fisher's exact test was used to compare the other data between the two groups.  Results:  Seventy patients (77 eyes) with pterygium were in this study, including 30 males and 40 females, aged from 50-70 years old. There were 35 cases (38 eyes) in the experimental group and 35 cases (39 eyes) in the control group. 12 months after operation there were 54 cases (60 eyes) including 28 cases (30 eyes) in the experimental group and 26 cases (30 eyes) in the control group with complete data. The corneal epithelium defects of 1 eye in each group was repaired within 7-14 days after operation, and the rest eyes were completely repaired within 7 days after operation. There was no significant difference in the distribution of corneal epithelial healing between the two groups ( P = 1.00). There was no significant difference between the two groups in the number of eyes distribute with decreased visual acuity (2 eyes in each group), stable visual acuity (15 eyes in the experimental group and 23 eyes in the control group), and improved visual acuity (13 eyes in the experimental group and 5 eyes in the control group) ( P =0.053). There was no recurrence in the two groups at 12 months after surgery, and there was no significant difference between the two groups in the number of patients with conjunctival hyperplasia of grades 1, 2 and 3 ( P =0.405).  Conclusions:  Modified conjunctival transplantation and amniotic membrane transplantation combined with use of IFN alpha-2b eye drops got low recurrence rate for primary pterygium and less damage to the healthy conjunctival tissue. This combined treatment strategy provides a new choice for the treatment of pterygium . (Chin J Ophthalmol, 2020, 56: 768-773) .",2020,There was no significant difference in the distribution of corneal epithelial healing between the two groups ( P = 1.00).,"['Seventy patients (77 eyes) with pterygium were in this study, including 30 males and 40 females, aged from 50-70 years old', 'primary pterygium', 'primary pterygium and less damage to the healthy conjunctival tissue', 'Patients with primary pterygium were treated from June 1, 2018 to December 31, 2018 in the Department of Ophthalmology, Beijing Tongren Hospital']","['pterygium resection combined with conjunctival autograft transplantation', 'modified conjunctival transplantation and amniotic membrane transplantation combined with use of interferon (IFN) alpha-2b eye drops', 'Modified conjunctival transplantation and amniotic membrane transplantation combined with use of IFN alpha-2b eye', 'modified conjunctival transplantation and amniotic membrane transplantation combined with use of IFN alpha-2b eye drops', 'primary pterygium with modified conjunctival transplantation and amniotic membrane transplantation combined with use of interferon eye drops']","['distribution of corneal epithelial healing', 'stable visual acuity', 'number of patients with conjunctival hyperplasia', 'visual acuity, corneal epithelial defect, and pterygium recurrence', 'visual acuity', 'visual acuity, intraocular pressure and anterior segment details', 'corneal epithelium defects', 'number of eyes distribute with decreased visual acuity', 'no recurrence']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0197133', 'cui_str': 'Simple excision of pterygium'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0021735', 'cui_str': 'Interferon Alfa-2b'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C1299691', 'cui_str': 'Corneal epithelial defect'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0854114', 'cui_str': 'Corneal epithelium defect'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0234632', 'cui_str': 'Reduced visual acuity'}]",,0.0325111,There was no significant difference in the distribution of corneal epithelial healing between the two groups ( P = 1.00).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Ophthalmology and Visual Science Key Laboratory, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Ophthalmology and Visual Science Key Laboratory, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Jie', 'Affiliation': 'Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Ophthalmology and Visual Science Key Laboratory, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Jin', 'Affiliation': 'Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Ophthalmology and Visual Science Key Laboratory, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'Z Q', 'Initials': 'ZQ', 'LastName': 'Pan', 'Affiliation': 'Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Ophthalmology and Visual Science Key Laboratory, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Li', 'Affiliation': 'Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Ophthalmology and Visual Science Key Laboratory, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Ophthalmology and Visual Science Key Laboratory, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}]",[Zhonghua yan ke za zhi] Chinese journal of ophthalmology,['10.3760/cma.j.cn112142-20191217-00651']
2950,33059433,Effectiveness of Neurodynamic Mobilization versus Conventional Therapy on Spasticity Reduction and Upper Limb Function in Tetraplegic Patients.,"Study Design


The study employed a pre- and post-test experimental design.
Purpose


This study was designed to assess the effect of neurodynamic mobilization of the median nerve on upper limb spasticity in tetraplegic patients.
Overview of Literature


Spasticity is a common and potentially disabling and bothersome complication in patients with spinal cord lesion; this disorder can negatively influence the quality of life by restricting the patient's ability to perform activities of daily living. Neural mobilization is currently used for reducing the spasticity in individuals with neurological disorders.
Methods


Twenty subjects with traumatic spinal cord injury (level C5-C8) and upper limb spasticity in the finger and wrist flexors were enrolled. They were randomly allocated to two different groups using a computer-generated randomization schedule: group I comprised the neurodynamic mobilization group (n=11) and group II was the conventional therapy group (n=9); the subjects were administered therapy for 5 days every week for a period of 4 weeks. Upper limb spasticity was assessed using the Modified Ashworth Scale for wrist and finger flexors; F-wave amplitude, latency, and F-wave/M-wave amplitude ratio (F/M ratio) were examined using the F-wave scores of the median nerve; and upper limb function was determined using the Capabilities of Upper Extremity (CUE) Questionnaire.
Results


After 4 weeks of intervention, between-group comparisons showed a significant difference in the pre-intervention and postintervention scores on the Modified Ashworth Scale score for wrist flexors (-1.64±0.67), Modified Ashworth Scale score for finger flexors (-1.00±0.63), F-wave amplitude (-154.09±220.86), F/M ratio (-0.18±0.24), and CUE scores (17.82±13.49).
Conclusions


These results suggest that neurodynamic mobilization of the median nerve may be effective for upper limb spasticity control and upper limb functional improvement in tetraplegic patients.",2020,"Upper limb spasticity was assessed using the Modified Ashworth Scale for wrist and finger flexors; F-wave amplitude, latency, and F-wave/M-wave amplitude ratio (F/M ratio) were examined using the F-wave scores of the median nerve; and upper limb function was determined using the Capabilities of Upper Extremity (CUE) Questionnaire.
","['individuals with neurological disorders', 'tetraplegic patients', 'Tetraplegic Patients', 'Twenty subjects with traumatic spinal cord injury (level C5-C8) and upper limb spasticity in the finger and wrist flexors were enrolled', 'patients with spinal cord lesion']","['neurodynamic mobilization group', 'conventional therapy', 'Neurodynamic Mobilization versus Conventional Therapy']","['Upper limb spasticity', 'Capabilities of Upper Extremity (CUE) Questionnaire', 'pre-intervention and postintervention scores on the Modified Ashworth Scale score for wrist flexors (-1.64±0.67), Modified Ashworth Scale score for finger flexors (-1.00±0.63), F-wave amplitude (-154.09±220.86), F/M ratio (-0.18±0.24), and CUE scores', 'Modified Ashworth Scale for wrist and finger flexors; F-wave amplitude, latency, and F-wave/M-wave amplitude ratio (F/M ratio', 'Spasticity Reduction and Upper Limb Function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",20.0,0.0202643,"Upper limb spasticity was assessed using the Modified Ashworth Scale for wrist and finger flexors; F-wave amplitude, latency, and F-wave/M-wave amplitude ratio (F/M ratio) were examined using the F-wave scores of the median nerve; and upper limb function was determined using the Capabilities of Upper Extremity (CUE) Questionnaire.
","[{'ForeName': 'Akanksha', 'Initials': 'A', 'LastName': 'Saxena', 'Affiliation': 'Department of Physiotherapy, Maharishi Markandeshwar University, Mullana, India.'}, {'ForeName': 'Stuti', 'Initials': 'S', 'LastName': 'Sehgal', 'Affiliation': 'Division of Neurology, Department of Physiotherapy, Indian Spinal Injuries Center-Institute of Rehabilitation Sciences, New Delhi, India.'}, {'ForeName': 'Mandeep Kumar', 'Initials': 'MK', 'LastName': 'Jangra', 'Affiliation': 'Division of Cardiothoracic & Pulmonary Disorders, Department of Physiotherapy, Maharishi Markandeshwar University, Mullana, India.'}]",Asian spine journal,['10.31616/asj.2020.0146']
2951,33064609,"Comparison of isoflurane, sevoflurane, and desflurane as inhalant anesthetics in prairie rattlesnakes ( Crotalus viridis ).","OBJECTIVE


To characterize induction and recovery characteristics of 3 commonly used inhalant anesthetics in prairie rattlesnakes ( Crotalus viridis ): isoflurane, sevoflurane, and desflurane.
ANIMALS


12 healthy adult prairie rattlesnakes.
PROCEDURES


In a randomized crossover design, snakes underwent anesthetic induction with 5% isoflurane, 8% sevoflurane, or 18% desflurane, with a washout period of ≥ 7 days between anesthetic events. Anesthetic depth parameters were recorded throughout induction and recovery, including time to loss and return of righting reflex, muscle tone, ability to intubate, response to pressure, and time to return to spontaneous respiration. Every 5 minutes throughout the anesthetic procedures, heart rate, respiratory rate, and percentage expired anesthetic gas were recorded.
RESULTS


No snakes died during the study. Sevoflurane anesthesia resulted in anesthetic gas avoidance behavior in snakes during induction and had the significantly longest recovery time to extubation and time to return of pressure response, compared with the other inhalant anesthetics. Anesthesia with isoflurane resulted in a significantly longer time to return of righting reflex, compared with sevoflurane or desflurane. No significant difference was noted in time to loss of pressure response among the 3 anesthetic gases. Desflurane anesthesia resulted in the significantly quickest loss of righting reflex among the anesthetic protocols; despite this, 4 of 12 desflurane anesthetized snakes did not achieve an anesthetic plane deep enough for intubation.
CONCLUSIONS AND CLINICAL RELEVANCE


Isoflurane and sevoflurane, but not desflurane, inhalation anesthesia resulted in consistent and predictable loss of righting reflex and induction of anesthesia deep enough to allow intubation in snakes.",2020,"Anesthesia with isoflurane resulted in a significantly longer time to return of righting reflex, compared with sevoflurane or desflurane.","['prairie rattlesnakes ( Crotalus viridis ', '12 healthy adult prairie rattlesnakes']","['isoflurane, sevoflurane, and desflurane', 'Sevoflurane anesthesia', 'isoflurane', 'inhalation anesthesia', 'Desflurane anesthesia', 'desflurane', 'anesthetic induction with 5% isoflurane, 8% sevoflurane, or 18% desflurane', 'sevoflurane']","['anesthetic gas avoidance behavior', 'time to loss of pressure response', 'longer time to return of righting reflex', 'time to loss and return of righting reflex, muscle tone, ability to intubate, response to pressure, and time to return to spontaneous respiration', 'quickest loss of righting reflex', 'heart rate, respiratory rate, and percentage expired anesthetic gas']","[{'cui': 'C0327530', 'cui_str': 'Crotalus confluentus'}, {'cui': 'C0327541', 'cui_str': 'Crotalus viridis'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0002917', 'cui_str': 'Anesthesia, Inhalation'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}]","[{'cui': 'C0242902', 'cui_str': 'Anesthetic Gases'}, {'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0234156', 'cui_str': 'Static reflex of Magnus and de Kleijn'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",12.0,0.035472,"Anesthesia with isoflurane resulted in a significantly longer time to return of righting reflex, compared with sevoflurane or desflurane.","[{'ForeName': 'Lauren P', 'Initials': 'LP', 'LastName': 'Kane', 'Affiliation': ''}, {'ForeName': 'Sathya K', 'Initials': 'SK', 'LastName': 'Chinnadurai', 'Affiliation': ''}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Vivirito', 'Affiliation': ''}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Strahl-Heldreth', 'Affiliation': ''}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Allender', 'Affiliation': ''}]",Journal of the American Veterinary Medical Association,['10.2460/javma.257.9.945']
2952,33064621,Teaching pursed-lip breathing through music: MELodica Orchestra for DYspnea (MELODY) trial rationale and protocol.,"BACKGROUND


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


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


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


If pilot data demonstrate efficacy, then a multi-site randomized control trial will be conducted to evaluate program effectiveness and implementation.",2020,"If pilot data demonstrate efficacy, then a multi-site randomized control trial will be conducted to evaluate program effectiveness and implementation.","['COPD patients', 'Patients with COPD and moderate-severe dyspnea', 'Patients with chronic obstructive pulmonary disease (COPD']","['music-based approach to teach pursed-lip breathing', 'Pursed-lip breathing']","['dyspnea', 'Safety, feasibility, and efficacy']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0425465', 'cui_str': 'Pursed-lip breathing'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.106147,"If pilot data demonstrate efficacy, then a multi-site randomized control trial will be conducted to evaluate program effectiveness and implementation.","[{'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'McGrath', 'Affiliation': 'Indiana University School of Medicine , Indianapolis, IN, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Indiana University School of Medicine , Indianapolis, IN, USA.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Rattray', 'Affiliation': 'Department of Veterans Affairs (VA) Health Services Research and Development (HSR&D) Precision Monitoring to Transform Care (PRISM) Quality Enhancement Research Initiative (QUERI) , Indianapolis, IN, USA.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Lillie', 'Affiliation': 'Department of Veterans Affairs (VA) Health Services Research and Development (HSR&D) Precision Monitoring to Transform Care (PRISM) Quality Enhancement Research Initiative (QUERI) , Indianapolis, IN, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Crow', 'Affiliation': 'Department of Veterans Affairs (VA) Health Services Research and Development (HSR&D) Precision Monitoring to Transform Care (PRISM) Quality Enhancement Research Initiative (QUERI) , Indianapolis, IN, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Myers', 'Affiliation': 'Department of Internal Medicine, Indiana University School of Medicine , Indianapolis, IN, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Myers', 'Affiliation': 'Department of Veterans Affairs (VA) Health Services Research and Development (HSR&D) Precision Monitoring to Transform Care (PRISM) Quality Enhancement Research Initiative (QUERI) , Indianapolis, IN, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Perkins', 'Affiliation': 'Department of Veterans Affairs (VA) Health Services Research and Development (HSR&D) Precision Monitoring to Transform Care (PRISM) Quality Enhancement Research Initiative (QUERI) , Indianapolis, IN, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wasmuth', 'Affiliation': 'School of Occupational Therapy, Indiana University School of Health & Human Sciences , Indianapolis, IN, USA.'}, {'ForeName': 'Debra S', 'Initials': 'DS', 'LastName': 'Burns', 'Affiliation': 'Department of Music and Arts Technology, Indiana University-Purdue University Indianapolis (IUPUI) , Indianapolis, IN, USA.'}, {'ForeName': 'Ariel J', 'Initials': 'AJ', 'LastName': 'Cheatham', 'Affiliation': 'Department of Veterans Affairs (VA) Health Services Research and Development (HSR&D) Precision Monitoring to Transform Care (PRISM) Quality Enhancement Research Initiative (QUERI) , Indianapolis, IN, USA.'}, {'ForeName': 'Himalaya', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'VA HSR&D Center for Health Information and Communication (CHIC), Richard L. Roudebush VA Medical Center , Indianapolis, IN, USA.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Bravata', 'Affiliation': 'Department of Internal Medicine, Indiana University School of Medicine , Indianapolis, IN, USA.'}]",Arts & health,['10.1080/17533015.2020.1827277']
2953,33064669,Pre-operative tranexemic acid vs. etamsylate in reducing blood loss during elective cesarean section: randomized controlled trial.,"Objectives To investigate whether etamsylate may be an alternative to tranexamic acid in reduction of blood loss during elective cesarean section. Methods Prospective double-blinded multi-center randomized controlled trial involving 180 qualified women equally divided into three groups each containing 60 women received either tranexamic acid, etamsylate or placebo 20 min before elective cesarean section and blood loss was estimated. Results Mean blood loss, cases needing blood transfusion and cases needing further interventions were significantly lower in tranexamic acid and etamsylate group than placebo group, while mean postoperative hemoglobin and hematocrite were significantly higher in both tranexamic acid and etamsylate as compared to placebo. Conclusions Etamsylate is an effective second-line therapy (after tranexamic acid) in reducing blood loss during elective cesarean section with low risk of side effects, therefore, it can be an effective alternative to tranexamic acid in cases with contraindications or anticipated to be at high-risk of developing side effects from tranexamic acid.",2020,"Results Mean blood loss, cases needing blood transfusion and cases needing further interventions were significantly lower in tranexamic acid and etamsylate group than placebo group, while mean postoperative hemoglobin and hematocrite were significantly higher in both tranexamic acid and etamsylate as compared to placebo.","['180 qualified women equally divided into three groups each containing 60 women received either', 'elective cesarean section']","['Pre-operative tranexemic acid vs. etamsylate', 'placebo', 'tranexamic acid', 'tranexamic acid, etamsylate or placebo']","['Mean blood loss, cases needing blood transfusion and cases needing further interventions', 'blood loss', 'mean postoperative hemoglobin and hematocrite']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0014968', 'cui_str': 'Ethamsylate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",180.0,0.260152,"Results Mean blood loss, cases needing blood transfusion and cases needing further interventions were significantly lower in tranexamic acid and etamsylate group than placebo group, while mean postoperative hemoglobin and hematocrite were significantly higher in both tranexamic acid and etamsylate as compared to placebo.","[{'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Torky', 'Affiliation': 'Department of Obstetrics and Gynecology, October 6th University, Giza, Egypt.'}, {'ForeName': 'El-Sayed', 'Initials': 'ES', 'LastName': 'El-Desouky', 'Affiliation': 'Department of Obstetrics and Gynecology, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Abo-Elmagd', 'Affiliation': 'Department of Obstetrics and Gynecology, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Attia', 'Initials': 'A', 'LastName': 'Mohamed', 'Affiliation': 'Department of Obstetrics and Gynecology, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Abdalhamid', 'Affiliation': 'Department of Obstetrics and Gynecology, Al-Azhar University, Assuit, Egypt.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'El-Shahat', 'Affiliation': 'Department of Obstetrics and Gynecology, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Sileem', 'Initials': 'S', 'LastName': 'Ahmed Sileem', 'Affiliation': 'Department of Obstetrics and Gynecology, Al-Azhar University, Assuit, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Tawfik', 'Affiliation': 'Department of Microbiology, Faculty of Pharmacy Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Abo-Louz', 'Affiliation': 'Department of Obstetrics and Gynecology, October 6th University, Giza, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hussein', 'Affiliation': 'Department of Obstetrics and Gynecology, October 6th University, Giza, Egypt.'}]",Journal of perinatal medicine,['10.1515/jpm-2020-0271']
2954,33064711,"Pregabalin as a premedication for anxiety in patients undergoing plastic surgery: randomized double-blind, placebo-controlled study.","Objective


To evaluate the usefulness of premedication with 75 mg pregabalin orally to reduce the degree of preoperative anxiety in patients scheduled for plastic surgery procedures.
Method


A controlled randomized double-blind clinical trial that analyzed two groups of patients: 75 mg pregabalin tablet (Pg) against placebo tablet (Pl). Efficacy was assessed using the visual anxiety scale (VAS) with two measurements, the first without medication and the second 70 minutes after the drug was taken.
Results


One hundred patients were evaluated, fifty received pregabalin and fifty placebo, baseline VAS score showed an general average of 4.6 ± 1.9 points, significantly higher in the Pg group (Pg 5.2 ± 2.1 points vs 4.1 ± 1.6 points Pl; p = 0.0035). The VAS score after premedication was 3.9 ± 2.1 points, significantly lower in the Pg group (Pg 3.2 ± 1.6 points vs 4.6 ± 2.3 Pl points, p = 0.0006).
Conclusion


Premedication 75 mg pregabalin orally decreases the degree of preoperative anxiety in adult patients scheduled for plastic surgery procedures.",2020,"The VAS score after premedication was 3.9 ± 2.1 points, significantly lower in the Pg group (Pg 3.2 ± 1.6 points vs 4.6 ± 2.3 Pl points, p = 0.0006).
","['patients undergoing plastic surgery', 'patients scheduled for plastic surgery procedures', 'One hundred patients', 'adult patients scheduled for plastic surgery procedures']","['pregabalin tablet (Pg) against placebo tablet (Pl', 'pregabalin', 'placebo', 'pregabalin and fifty placebo', 'Pregabalin']","['baseline VAS score', 'visual anxiety scale (VAS', 'VAS score', 'Efficacy', 'degree of preoperative anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0677616', 'cui_str': 'Plastic operation'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]",100.0,0.401957,"The VAS score after premedication was 3.9 ± 2.1 points, significantly lower in the Pg group (Pg 3.2 ± 1.6 points vs 4.6 ± 2.3 Pl points, p = 0.0006).
","[{'ForeName': 'Ludivina A', 'Initials': 'LA', 'LastName': 'Cortés-Martínez', 'Affiliation': 'Departamento de Anestesiología, Hospital Ángeles Lomas, Ciudad de México.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Cardoso-García', 'Affiliation': 'Departamento de Anestesiología, Hospital Ángeles Lomas, Ciudad de México.'}, {'ForeName': 'Yazmin', 'Initials': 'Y', 'LastName': 'Galván-Talamantes', 'Affiliation': 'Departamento de Anestesiología, Hospital Ángeles Lomas, Ciudad de México.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Morales-Maza', 'Affiliation': 'Departamento de Cirugía, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Ciudad de México.'}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Rosas-Sánchez', 'Affiliation': 'Centro Oncológico Estatal Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Estado de México. México.'}, {'ForeName': 'Dulce M', 'Initials': 'DM', 'LastName': 'Vargas-Aguilar', 'Affiliation': 'Departamento de Anestesiología, Hospital Ángeles Lomas, Ciudad de México.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Bañuelos-Ortiz', 'Affiliation': 'Departamento de Anestesiología, Hospital Ángeles Lomas, Ciudad de México.'}, {'ForeName': 'Gerardo E', 'Initials': 'GE', 'LastName': 'Álvarez-Reséndiz', 'Affiliation': 'Departamento de Anestesiología, Hospital Ángeles Lomas, Ciudad de México.'}]",Cirugia y cirujanos,['10.24875/CIRU.20001684']
2955,33065060,Effects of canagliflozin on anaemia in patients with type 2 diabetes and chronic kidney disease: a post-hoc analysis from the CREDENCE trial.,"BACKGROUND


Sodium-glucose co-transporter 2 inhibitors might enhance erythropoiesis and increase red blood cell mass. We assessed the long-term effects of canagliflozin on anaemia-related outcomes.
METHODS


In a post-hoc analysis of the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial, we included patients with type 2 diabetes and chronic kidney disease who were randomly assigned to treatment with canagliflozin or placebo at 690 sites in 34 countries. We assessed the effects of canagliflozin versus matched placebo on haemoglobin and haematocrit using linear mixed-effects models. The primary outcome of this post-hoc analysis was a composite outcome of investigator-reported anaemia or treatment for anaemia, which was assessed using Kaplan-Meier analysis and Cox regression models. All analyses were done by intention to treat.
FINDINGS


Between March 24, 2014, and May 5, 2017, 4401 participants were randomly assigned to receive canagliflozin (100 mg; n=2202) or placebo (n=2199). At baseline, mean haemoglobin concentration was 132·0 g/L (SD 17·7), 1599 (36%) of 4401 participants had anaemia (defined as haemoglobin <130 g/L in men or <120 g/L in women), and 33 (<1%) of 4401 participants used erythropoiesis-stimulating agents. During a median follow-up period of 2·6 years (IQR 2·1-3·1), mean haemoglobin concentration was 7·1 g/L (95% CI 6·4-7·8) higher and haematocrit was 2·4% (2·2-2·6) higher in the canagliflozin group than the placebo group. Overall, 573 of 4401 participants had either an investigator-reported anaemia event or initiation of treatment for anaemia: 358 (8%) of 4401 participants reported anaemia events, 343 (8%) initiated iron preparations, 141 (3%) initiated erythropoiesis-stimulating agents, and 114 (2%) received blood transfusion. The risk of the composite outcome of anaemia events or initiation of treatment for anaemia was lower in the canagliflozin group than the placebo group (hazard ratio 0·65, 95% CI 0·55-0·77; p<0·0001). Compared with the placebo group, participants in the canagliflozin group also had lower risks of anaemia events alone (0·58, 0·47-0·72; p<0·0001), initiation of iron preparations (0·64, 0·52-0·80; p<0·0001), and need for erythropoiesis-stimulating agents (0·65, 0·46-0·91; p=0·012).
INTERPRETATION


These data suggest that canagliflozin reduces the risk of anaemia-associated outcomes, including the need for erythropoiesis-stimulating agents, among patients with type 2 diabetes and chronic kidney disease.
FUNDING


Janssen Research and Development.",2020,"Compared with the placebo group, participants in the canagliflozin group also had lower risks of anaemia events alone (0·58, 0·47-0·72; p<0·0001), initiation of iron preparations (0·64, 0·52-0·80; p<0·0001), and need for erythropoiesis-stimulating agents (0·65, 0·46-0·91; p=0·012).
","['0·65', 'patients with type 2 diabetes and chronic kidney disease', 'Between March 24, 2014, and May 5, 2017, 4401 participants']","['canagliflozin', 'canagliflozin or placebo', 'placebo']","['haematocrit', 'lower risks of anaemia events', 'haemoglobin and haematocrit', 'composite outcome of investigator-reported anaemia or treatment for anaemia', 'anaemia', 'mean haemoglobin concentration', 'anaemia event or initiation of treatment for anaemia', 'blood transfusion', 'anaemia events or initiation of treatment for anaemia', 'anaemia events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",4401.0,0.640331,"Compared with the placebo group, participants in the canagliflozin group also had lower risks of anaemia events alone (0·58, 0·47-0·72; p<0·0001), initiation of iron preparations (0·64, 0·52-0·80; p<0·0001), and need for erythropoiesis-stimulating agents (0·65, 0·46-0·91; p=0·012).
","[{'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Oshima', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Department of Nephrology and Laboratory Medicine, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Brendon L', 'Initials': 'BL', 'LastName': 'Neuen', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Concord Repatriation General Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Edwards', 'Affiliation': 'Janssen Research and Development, Raritan, NJ, USA.'}, {'ForeName': 'Adeera', 'Initials': 'A', 'LastName': 'Levin', 'Affiliation': 'Division of Nephrology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; The Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia; Imperial College London, London, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Pollock', 'Affiliation': 'Kolling Institute of Medical Research, Sydney Medical School, Sydney, NSW, Australia; Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Rosenthal', 'Affiliation': 'Janssen Research and Development, Raritan, NJ, USA.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Wada', 'Affiliation': 'Department of Nephrology and Laboratory Medicine, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Department of Renal Medicine, University College London, London, UK.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands. Electronic address: h.j.lambers.heerspink@umcg.nl.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30300-4']
2956,33065070,SGLT2 inhibitors and thiazide enhance excretion of DEHP toxic metabolites in subjects with type 2 diabetes: a randomized clinical trial.,"OBJECTIVE


Phthalates are non-persistent pollutants related to impaired metabolism and high cardiovascular risk. Their toxic metabolites are eliminated through urine and feces. Prevention policies are considered by the governments, although no therapeutic strategy to facilitate their elimination from the human body has been proposed so far. Aim of the present study was to verify, for the first time in humans, whether diuretics might be able to enhance phthalates' toxic metabolites urinary output.
DESIGN AND METHODS


We conducted a two-armed, parallel-design, randomized clinical trial. Thirty patients with type 2 diabetes and hypertension received a four week-treatment with Dapaglifozin 10 mg or Hydrochlorothiazide 12.5 mg. 24-hours urine were collected to measure urinary excretion of three major 2-ethylhexyl-phthalate (DEHP) metabolites, i.e. mono 2-ethylhexyl phthalate (MEHP), mono-2-ethyl-5-oxohexyl phthalate (MEOHP) and mono 2-ethyl-5-hydroxyhexyl phthalate (MEHHP).
RESULTS


24-hours urinary excretion of DEHP and MEHP was increased (+44%, p=0.036; +49%, p=0.0016) while MEOHP e MEHHP showed only a positive trend (+25%, p=0.016; +36%, p=0.062). Irrespective of the specific treatment, induced variations of daily urinary eliminations of MEHP metabolites were related with the 24-hour urinary sodium (r=0.42, p=0.0226) and potassium (r=0.54, p=0.0026) excretion. Also, DEHP and MEOHP were related to sodium (r=0·43, p=0·0205; r=0·44, p= 0·0168 respectively) but not to potassium.
CONCLUSIONS


Urinary phthalates excretion seems to occur mainly through sodium- and potassium-related mechanisms, apparently independent from the different diuretic effect. Both thiazide diuretics and SLGT2 inhibitors are effective into the removal of phthalates metabolites from the human body, reducing the human tissues' exposure to their toxicity.",2020,"RESULTS


24-hours urinary excretion of DEHP and MEHP was increased (+44%, p=0.036; +49%, p=0.0016) while MEOHP e MEHHP showed only a positive trend (+25%, p=0.016; +36%, p=0.062).","['Thirty patients with type 2 diabetes and hypertension', 'subjects with type 2 diabetes']","['SGLT2 inhibitors and thiazide', 'Dapaglifozin 10 mg or Hydrochlorothiazide', 'thiazide diuretics and SLGT2 inhibitors']","['DEHP toxic metabolites', '24-hours urinary excretion of DEHP and MEHP', 'DEHP and MEOHP', 'urinary excretion of three major 2-ethylhexyl-phthalate (DEHP) metabolites, i.e. mono 2-ethylhexyl phthalate (MEHP), mono-2-ethyl-5-oxohexyl phthalate (MEOHP) and mono 2-ethyl-5-hydroxyhexyl phthalate (MEHHP', '24-hour urinary sodium', 'daily urinary eliminations of MEHP metabolites']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0012197', 'cui_str': 'Di-2-ethylhexyl phthalate'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0220894', 'cui_str': 'Phthalic acid ester'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1320408', 'cui_str': 'Urinary elimination status'}]",30.0,0.0815342,"RESULTS


24-hours urinary excretion of DEHP and MEHP was increased (+44%, p=0.036; +49%, p=0.0016) while MEOHP e MEHHP showed only a positive trend (+25%, p=0.016; +36%, p=0.062).","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Mengozzi', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Fabrizia', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Guiducci', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Parolini', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Biancalana', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Gastaldelli', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy. Electronic address: amalia@ifc.cnr.it.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Solini', 'Affiliation': 'Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy. Electronic address: anna.solini@med.unipi.it.'}]",Environmental research,['10.1016/j.envres.2020.110316']
2957,33065080,Safety and Efficacy of 1-Month Dual Antiplatelet Therapy (Ticagrelor + Aspirin) Followed by 23-Month Ticagrelor Monotherapy in Patients Undergoing Staged Percutaneous Coronary Intervention (A Sub-Study from GLOBAL LEADERS).,"Patients undergoing staged percutaneous coronary intervention (SPCI) are exposed to extended duration of antiplatelet therapy, and a novel aspirin-free antiplatelet regimen after SPCI should be specifically evaluated among these patients. This is a prespecified sub-study of the GLOBAL LEADERS which is a randomized, open-label trial, comparing an experimental regimen of 1-month dual antiplatelet therapy (DAPT) (ticagrelor and aspirin) followed by 23-month ticagrelor monotherapy to a reference regimen of 12-month DAPT followed by 12-month aspirin monotherapy. Patients were stratified according to whether or not SPCI was performed. The impact of the timing of SPCI on clinical outcomes was also investigated. Of 15,968 randomized patients, 1,651 patients underwent SPCI within 3 months. These patients with SPCI had a significantly higher risk of bleeding and ischemic endpoints than those without SPCI. In patients undergoing SPCI, the primary endpoint (composite of all-cause death or new Q-wave myocardial infarction at 2 years) and secondary safety endpoint (Bleeding Academic Research Consortium [BARC]-defined bleeding 3 or 5) were similar in the 2 regimens. However, in patients presenting with acute coronary syndrome (ACS), the experimental regimen reduced a risk of BARC 3 or 5 bleeding (1.8% vs. 4.5%; HR 0.387; 95% CI 0.179-0.836; p=0.016). In patients undergoing SPCI later than 10 days after index procedure, this risk reduction was still prominent (0.8% vs. 2.3%; HR 0.321; 95% CI 0.116-0.891; p=0.029). In conclusion, patients undergoing SPCI are at high risk and may need special attention from clinicians. In ACS patients undergoing SPCI, a novel aspirin-free antiplatelet regimen appears to be associated with a lower bleeding risk than with standard DAPT.",2020,"In ACS patients undergoing SPCI, a novel aspirin-free antiplatelet regimen appears to be associated with a lower bleeding risk than with standard DAPT.","['Patients Undergoing', 'patients presenting with acute coronary syndrome (ACS', 'Patients undergoing staged percutaneous coronary intervention (SPCI', '15,968 randomized patients, 1,651 patients underwent SPCI within 3 months']","['1-Month Dual Antiplatelet Therapy (Ticagrelor\u202f+\u202fAspirin', 'Ticagrelor Monotherapy', 'Staged Percutaneous Coronary Intervention', 'aspirin monotherapy', 'dual antiplatelet therapy (DAPT) (ticagrelor and aspirin']","['primary endpoint (composite of all-cause death or new Q-wave myocardial infarction at 2 years) and secondary safety endpoint (Bleeding Academic Research Consortium [BARC]-defined bleeding 3 or 5', 'risk of bleeding and ischemic endpoints', 'Safety and Efficacy', 'bleeding risk', 'risk of BARC 3 or 5 bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0429089', 'cui_str': 'Electrocardiogram Q waves'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",15968.0,0.031278,"In ACS patients undergoing SPCI, a novel aspirin-free antiplatelet regimen appears to be associated with a lower bleeding risk than with standard DAPT.","[{'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center; Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands; Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center; Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands; Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center; Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center; Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Sharif', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Thury', 'Affiliation': 'Cardiology Centre, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Suryapranata', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Walsh', 'Affiliation': 'Department of Cardiology Belfast Health & Social Care Trust, Belfast, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cotton', 'Affiliation': 'Heart and Lung Centre, New Cross Hospital, Wolverhampton, UK.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrie', 'Affiliation': 'Department of Cardiology, Rangueil hospital, Paul Sabatier University Toulouse 3, Toulouse, France.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabate', 'Affiliation': 'Clinic Hospital Barcelona, Barcelona, Spain.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Steinwender', 'Affiliation': 'Department of Cardiology Kepler University Hospital Linz Medical Faculty, Johannes Kepler University Linz 40201 Linz, Krankenhausstrasse 9, Austria.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Leibundgut', 'Affiliation': 'Department of Cardiology, Kantonsspital Baselland, Standort Liestal, Liestal, Switzerland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wykrzykowska', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center; Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center; Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Royal Blackburn Hospital, Blackburn, United Kingdom.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heart Center, Campus University of Giessen, Bad Nauheim, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université Paris-Diderot, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, INSERM U-1148, FACT (French Alliance for Cardiovascular Trials), Paris, France; National Heart and Lung Institute, Royal Brompton Hospital, Imperial College, London, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; NHLI, Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.09.057']
2958,33065120,"Rationale and design of ApoA-I event reducing in ischemic syndromes II (AEGIS-II): A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy and safety of CSL112 in subjects after acute myocardial infarction.","Acute myocardial infarction (AMI) patients remain at high risk for recurrent events. Cholesterol efflux, mediated by apolipoprotein A-I (apoA-I), removes excess cholesterol from atherosclerotic plaque and transports it to the liver for excretion. Impaired cholesterol efflux is associated with higher cardiovascular (CV) event rates among both patients with stable coronary artery disease (CAD) and recent myocardial infarction (MI). CSL112, a novel intravenous formulation of apoA-I (Human) derived from human plasma, increases cholesterol efflux capacity. AEGIS-II is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial investigating the efficacy and safety of CSL112 compared to placebo among high-risk AMI participants. Eligibility criteria include age≥18years with type 1 (spontaneous) MI, evidence of multivessel CAD, and presence of diabetes requiring pharmacotherapy, or≥2 of the following: age≥65years, prior MI or peripheral artery disease. A target sample of 17,400 participants will be randomized 1:1 to receive 4 weekly infusions of CSL112 6g or placebo, initiated prior to or on the day of discharge and within 5days of first medical contact. The primary outcome is the time to first occurrence of the composite of CV death, MI, or stroke through 90days. Key secondary outcomes include the total number of hospitalizations for coronary, cerebral, or peripheral ischemia through 90days, and time to first occurrence of the composite primary outcome through 180 and 365days. AEGIS-II will be the first trial to formally test whether enhancing cholesterol efflux can reduce the rate of recurrent major adverse CV events.",2020,AEGIS-II will be the first trial to formally test whether enhancing cholesterol efflux can reduce the rate of recurrent major adverse CV events.,"['Eligibility criteria include age≥18years with type 1 (spontaneous) MI, evidence of multivessel CAD, and presence of diabetes requiring pharmacotherapy, or≥2 of the following: age≥65years, prior MI or peripheral artery disease', 'patients with stable coronary artery disease (CAD) and recent myocardial infarction (MI', 'subjects after acute myocardial infarction', 'high-risk AMI participants', '17,400 participants']","['CSL112', 'placebo', 'CSL112 6g or placebo', 'ApoA']","['ischemic syndromes II (AEGIS-II', 'efficacy and safety', 'time to first occurrence of the composite of CV death, MI, or stroke through 90days', 'total number of hospitalizations for coronary, cerebral, or peripheral ischemia through 90days, and time to first occurrence of the composite primary outcome through 180 and 365days', 'cholesterol efflux capacity']","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1998297', 'cui_str': 'Recent myocardial infarction'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C3712106', 'cui_str': 'CSL112'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0003592', 'cui_str': 'Apolipoprotein A'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0235490', 'cui_str': 'Peripheral ischemia'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",17400.0,0.486277,AEGIS-II will be the first trial to formally test whether enhancing cholesterol efflux can reduce the rate of recurrent major adverse CV events.,"[{'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'From PERFUSE Study Group, Cardiovascular Division, Departments of Medicine, Beth, Israel, Deaconess Medical Center, Harvard Medical School, Boston, MA. Electronic address: mgibson@bidmc.harvard.edu.'}, {'ForeName': 'John J P', 'Initials': 'JJP', 'LastName': 'Kastelein', 'Affiliation': 'Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Adam T', 'Initials': 'AT', 'LastName': 'Phillips', 'Affiliation': 'From PERFUSE Study Group, Cardiovascular Division, Departments of Medicine, Beth, Israel, Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Philip E', 'Initials': 'PE', 'LastName': 'Aylward', 'Affiliation': 'South Australian Health and Medical Research Institute, Flinders University and Medical Centre, Adelaide, Australia.'}, {'ForeName': 'Megan K', 'Initials': 'MK', 'LastName': 'Yee', 'Affiliation': 'From PERFUSE Study Group, Cardiovascular Division, Departments of Medicine, Beth, Israel, Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Tendera', 'Affiliation': 'Department of Cardiology and Structural Heart Disease, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash University, Melbourne, Australia.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London, School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, and St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Cardiovascular Division, Department of Medicine, Duke University Health, Durham, NC.'}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Lincoff', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bode', 'Affiliation': 'Heart Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Duffy', 'Affiliation': 'CSL Behring, LLC, King of Prussia, PA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Heise', 'Affiliation': 'CSL Behring, LLC, King of Prussia, PA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Berman', 'Affiliation': 'Paratek Pharmaceuticals, King of Prussia, PA, USA.'}, {'ForeName': 'Sojaita Jenny', 'Initials': 'SJ', 'LastName': 'Mears', 'Affiliation': 'CSL Behring, LLC, King of Prussia, PA.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Tricoci', 'Affiliation': 'Duke Clinical Research Institute, Cardiovascular Division, Department of Medicine, Duke University Health, Durham, NC; CSL Behring, LLC, King of Prussia, PA.'}, {'ForeName': 'Lawrence I', 'Initials': 'LI', 'LastName': 'Deckelbaum', 'Affiliation': 'CSL Behring, LLC, King of Prussia, PA.'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Assistance Publique - Hopitaux de Paris, and Université de Paris, Paris, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ridker', 'Affiliation': ""Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Cardiovascular Institute, Mount Sinai, New York, NY.'}]",American heart journal,['10.1016/j.ahj.2020.10.052']
2959,33064852,A comparative study between preoperative rectal misoprostol and intraoperative intrauterine administration in the reduction of blood loss during and after cesarean delivery: A randomized controlled trial.,"OBJECTIVE


To compare the efficacy and safety of rectal misoprostol with intrauterine misoprostol in the reduction of blood loss during and after cesarean delivery.
METHODS


Ninety-eight pregnant women, all candidates for elective cesarean delivery, were equally randomized into two groups: the rectal group (received preoperative misoprostol rectally) and the intrauterine group (received intrauterine misoprostol after the delivery of the placenta). The primary outcome was the estimated blood loss (EBL) during cesarean delivery. Secondary outcomes included the occurrence of excessive blood loss (>1000 mL) within the first 24 hours postoperatively and the occurrence of any maternal or fetal side effects.
RESULTS


There were no statistically significant differences between the two groups regarding either the EBL (693.12±139.09 vs 692.39±132.83; P=0.979) or the occurrence of postpartum hemorrhage (>1000 mL) (6.1% vs 4.1%; P=0.99. Apgar scores at 1 and 5 minutes were significantly higher in the intrauterine group compared to the rectal group.
CONCLUSION


Insertion of intrauterine misoprostol is as effective as rectal insertion in reducing blood loss during and after cesarean delivery; however, it has a safer neonatal outcome and is more convenient when administered during cesarean delivery. ClinicalTrials.gov: NCT03723031.",2020,"Apgar scores at 1 and 5 minutes were significantly higher in the intrauterine group compared to the rectal group.
","['Ninety-eight pregnant women, all candidates for elective cesarean delivery', 'during and after cesarean delivery']","['preoperative rectal misoprostol and intraoperative intrauterine administration', 'rectal group (received preoperative misoprostol rectally', 'intrauterine misoprostol', 'intrauterine group (received intrauterine misoprostol', 'rectal misoprostol with intrauterine misoprostol']","['EBL', 'Apgar scores', 'blood loss', 'occurrence of postpartum hemorrhage', 'efficacy and safety', 'occurrence of excessive blood loss', 'occurrence of any maternal or fetal side effects', 'estimated blood loss (EBL']","[{'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",98.0,0.177543,"Apgar scores at 1 and 5 minutes were significantly higher in the intrauterine group compared to the rectal group.
","[{'ForeName': 'Moutaz M', 'Initials': 'MM', 'LastName': 'El-Sherbini', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Maged', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Omneya M', 'Initials': 'OM', 'LastName': 'Helal', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mirna O', 'Initials': 'MO', 'LastName': 'Awad', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'El-Attar', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Jehan A', 'Initials': 'JA', 'LastName': 'Sadek', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'ElKomy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mariam A', 'Initials': 'MA', 'LastName': 'Dawoud', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13426']
2960,33065035,"Efficacy, immunogenicity, and safety of a plant-derived, quadrivalent, virus-like particle influenza vaccine in adults (18-64 years) and older adults (≥65 years): two multicentre, randomised phase 3 trials.","BACKGROUND


Seasonal influenza remains a substantial public health threat despite the availability of egg-derived and other vaccines. Plant-based manufacturing might address some of the limitations of current vaccines. We describe two phase 3 efficacy studies of a recombinant quadrivalent virus-like particle (QVLP) influenza vaccine manufactured in plants, one in adults aged 18-64 years (the 18-64 study) and one in older people aged 65 years and older (the 65-plus study).
METHODS


We did two randomised, observer-blind, multinational studies in the northern hemisphere in the 2017-18 (the 18-64 study) and 2018-19 (the 65-plus study) influenza seasons. The 18-64 study was done at 73 sites and the 65-plus study was done at 104 sites, both across Asia, Europe, and North America. In the 18-64 study, inclusion criteria were body-mass index less than 40 kg/m 2 ; age 18-64 years at screening visit; and good health. In the 65-plus study, inclusion criteria were body-mass index of maximum 35 kg/m 2 ; aged 65 years or older at screening visit; not living in a rehabilitation centre or care home; and no acute or evolving medical problems. Participants in the 18-64 study were randomly assigned (1:1) to receive either QVLP vaccine (30 μg haemagglutinin per strain) or placebo. Participants in the 65-plus study were randomly assigned (1:1) to receive QVLP vaccine (30 μg haemagglutinin per strain) or quadrivalent inactivated vaccine (QIV; 15 μg haemagglutinin per strain). The primary outcome in the 18-64 study was absolute vaccine efficacy to prevent laboratory-confirmed, respiratory illness caused by antigenically matched influenza strains. The primary outcome in the 65-plus study was relative vaccine efficacy to prevent laboratory-confirmed influenza-like illness caused by any influenza strain. The primary analyses were done in the per-protocol population and safety was assessed in all participants who received the assigned treatment. These studies are registered with ClinicalTrials.gov (18-64 study NCT03301051; 65-plus study NCT03739112).
FINDINGS


In the 18-64 study, between Aug 30, 2017, and Jan 15, 2018, 10 160 participants were randomly assigned to receive either QVLP vaccine (5077 participants) or placebo (5083 participants). The per-protocol population consisted of 4814 participants in the QVLP group and 4812 in the placebo group. The study did not meet its primary endpoint of 70% absolute vaccine efficacy for the QVLP vaccine (35·1% [95% CI 17·9 to 48·7]) against respiratory illness caused by matched strains. 55 (1·1%) of 5064 participants in the QVLP group versus 51 (1·0%) of 5072 in the placebo group had a serious adverse event. Four (0·1%) and six [0·1%] participants had severe treatment-related treatment-emergent adverse events. In the 65-plus study, between Sept 18, 2018, and Feb 22, 2019, 12 794 participants were randomly assigned to receive either QVLP vaccine (6396 participants) or QIV (6398 participants). The per-protocol population consisted of 5996 participants in the QVLP group and 6026 in the QIV group. The study met its primary non-inferiority endpoint with a relative vaccine efficacy of the QVLP vaccine for the prevention of influenza-like illness caused by any strain of 8·8% (-16·7 to 28·7). 263 (4·1%) of 6352 participants in the QVLP group versus 266 (4·2%) of 6366 in the QIV group had serious adverse events (one [<0·1%] vs two [<0·1%] were considered treatment-related); one (<0·1%) versus three (<0·1%) participants had severe treatment-related treatment-emergent adverse events.
INTERPRETATION


These efficacy studies are the first large-scale studies of any plant-derived human vaccine. Together, they show that the plant-derived QVLP vaccine can provide substantial protection against respiratory illness and influenza-like illness caused by influenza viruses in adults. QVLP vaccine was well tolerated and no major safety signal arose in participants who received QVLP vaccine across the two studies.
FUNDING


Medicago.",2020,"QVLP vaccine was well tolerated and no major safety signal arose in participants who received QVLP vaccine across the two studies.
","['In the 65-plus study, between Sept 18, 2018, and Feb 22, 2019, 12\u2008794 participants', 'adults (18-64 years) and older adults (≥65 years', 'The 18-64 study was done at 73 sites and the 65-plus study was done at 104 sites, both across Asia, Europe, and North America', '6396 participants) or QIV (6398 participants', 'Participants in the 65-plus study', 'northern hemisphere in the 2017-18 (the 18-64 study) and 2018-19 (the 65-plus study) influenza seasons', 'In the 18-64 study, between Aug 30, 2017, and Jan 15, 2018, 10\u2008160 participants', '4814 participants in the QVLP group and 4812 in the placebo group', 'adults aged 18-64 years (the 18-64 study) and one in older people aged 65 years and older (the 65-plus study', 'In the 65-plus study, inclusion criteria were body-mass index of maximum 35 kg/m 2 ; aged 65 years or older at screening visit; not living in a rehabilitation centre or care home; and no acute or evolving medical problems', 'for the prevention of influenza-like illness caused by any strain of 8·8% (-16·7 to 28·7', '5996 participants in the QVLP group and 6026 in the QIV group', 'In the 18-64 study, inclusion criteria were body-mass index less than 40 kg/m 2 ; age 18-64 years at screening visit; and good health', 'Participants in the 18-64 study']","['QVLP vaccine (30 μg haemagglutinin per strain) or quadrivalent inactivated vaccine (QIV; 15 μg haemagglutinin per strain', 'plant-derived, quadrivalent, virus-like particle influenza vaccine', 'plant-derived QVLP vaccine', 'QVLP', 'placebo', 'recombinant quadrivalent virus-like particle (QVLP) influenza vaccine manufactured', 'QVLP vaccine']","['vaccine efficacy', 'Efficacy, immunogenicity, and safety', 'tolerated and no major safety signal', 'relative vaccine efficacy to prevent laboratory-confirmed influenza-like illness caused by any influenza strain', 'serious adverse event', 'absolute vaccine efficacy to prevent laboratory-confirmed, respiratory illness', 'respiratory illness', 'serious adverse events', 'severe treatment-related treatment-emergent adverse events']","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0333785', 'cui_str': 'Virus-like particles'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C2936379', 'cui_str': 'Virus-Like Particle Vaccines'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0333785', 'cui_str': 'Virus-like particles'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",12794.0,0.380196,"QVLP vaccine was well tolerated and no major safety signal arose in participants who received QVLP vaccine across the two studies.
","[{'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Ward', 'Affiliation': 'Medicago, Quebec, QC, Canada; Research Institute of the McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Makarkov', 'Affiliation': 'Medicago, Quebec, QC, Canada.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Séguin', 'Affiliation': 'Medicago, Quebec, QC, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Pillet', 'Affiliation': 'Medicago, Quebec, QC, Canada.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Trépanier', 'Affiliation': 'Medicago, Quebec, QC, Canada.'}, {'ForeName': 'Jiwanjeet', 'Initials': 'J', 'LastName': 'Dhaliwall', 'Affiliation': 'Medicago, Quebec, QC, Canada.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Libman', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Vesikari', 'Affiliation': 'Nordic Research Network Oy, Tampere, Finland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Landry', 'Affiliation': 'Medicago, Quebec, QC, Canada. Electronic address: landryn@medicago.com.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)32014-6']
2961,33065218,The occlusal wear of ceramic fixed dental prostheses: 3-year results in a randomized controlled clinical trial with split-mouth design.,"OBJECTIVES


This study's hypothesis was to evaluate differences of the occlusal wear rate for monolithically fabricated lithium disilicate and hand-veneered zirconia crowns in-vivo. Furthermore, a comparison of the materials' clinical performance according to CDA criteria was investigated.
METHODS


A total number of 15 patients in the need of full-coverage ceramic fixed dental prosthesis on molars were treated with two crowns each (n = 30), randomly assigned on the contralateral sides made of monolithic IPS e.max CAD (n = 15) and IPS e.max Ceram hand-veneered zirconia (n = 15). Clinical examination was conducted, silicone impressions were taken and plaster models fabricated at the day of crown insertion (baseline) and after 1, 2 and 3 years. The abrasion rate was digitally investigated: after model digitization with the industrial scanner Atos II, each follow-up model was superimposed with the baseline model. The wear was evaluated as the difference between two scans in terms of maximum vertical loss [mm], average decrease [mm] and volume loss [mm³]. For statistical analysis, the Mann-Whitney U-Test was performed and significance was set to less than 0.05.
RESULTS


IPS e.max CAD crowns showed a volume loss of -0.68 mm³ after three years, while IPS e.max Ceram hand-veneered zirconia crowns showed a volumetric wear of -0.75 mm³ at the same point of time. However, no significant differences were found between both materials regarding the 3 evaluated wear parameters. The survival rate for both materials was 100% and the clinical performance outcome was good to excellent.
CONCLUSION


The two investigated materials for ceramic fixed dental prostheses showed similar wear rates and clinical performance over an in-vivo use of 3 years.
CLINICAL SIGNIFICANCE


Ceramic restorations are subject to occlusal wear over time due to the natural masticatory process. Both monolithic lithium disilicate and glass-ceramic veneered zirconia copings showed clinically satisfactory results over 3 years in-situ. In terms of abrasion, they are equally well suited for clinical use.",2020,"The two investigated materials for ceramic fixed dental prostheses showed similar wear rates and clinical performance over an in-vivo use of 3 years.
",['15 patients in the need of full-coverage ceramic fixed dental prosthesis on molars were treated with two crowns each (n\u2009=\u200930'],"['monolithic lithium disilicate and glass-ceramic veneered zirconia copings', 'monolithic IPS e.max CAD (n\u2009=\u200915) and IPS e.max Ceram hand-veneered zirconia']","['wear rates and clinical performance', 'volume loss', 'survival rate', 'abrasion rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0010384', 'cui_str': 'Crown'}]","[{'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0559953', 'cui_str': 'Veneer'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C4508100', 'cui_str': 'IPS e.max Ceram'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}]",,0.0308029,"The two investigated materials for ceramic fixed dental prostheses showed similar wear rates and clinical performance over an in-vivo use of 3 years.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Seidel', 'Affiliation': 'Department of Prosthodontics, University Hospital Erlangen of Friedrich-Alexander University Erlangen-Nürnberg (FAU), Glueckstrasse 11, 91054, Erlangen, Germany. Electronic address: anna.seidel@uk-erlangen.de.'}, {'ForeName': 'Renan', 'Initials': 'R', 'LastName': 'Belli', 'Affiliation': 'Laboratory of Dental Biomaterials, Department of Restorative Dentistry, University Hospital Erlangen of Friedrich-Alexander University Erlangen Nürnberg (FAU), Glueckstrasse 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Breidebach', 'Affiliation': 'Department of Prosthodontics, University Hospital Erlangen of Friedrich-Alexander University Erlangen-Nürnberg (FAU), Glueckstrasse 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Wichmann', 'Affiliation': 'Department of Prosthodontics, University Hospital Erlangen of Friedrich-Alexander University Erlangen-Nürnberg (FAU), Glueckstrasse 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Ragai Edward', 'Initials': 'RE', 'LastName': 'Matta', 'Affiliation': 'Department of Prosthodontics, University Hospital Erlangen of Friedrich-Alexander University Erlangen-Nürnberg (FAU), Glueckstrasse 11, 91054, Erlangen, Germany.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103500']
2962,33065228,Short and long-term effects of water-based aerobic and concurrent training on cardiorespiratory capacity and strength of older women.,"Studies show that, in the short term, water-based aerobic training (WAT) promotes the same strength gains as water-based concurrent training (WCT). In addition, it is known that some training progression strategy must be employed after the first weeks of training in order to continue stimulating neuromuscular gains. The aim of this paper was to compare the effects of three water-based training on cardiorespiratory capacity and strength of older women in short and long-terms. Fifty-seven participants were randomized into the groups: 1) aerobic training (AT); 2) concurrent training whose resistance training progressed to the use of resistive equipment (CTRE); and 3) concurrent training whose resistance training progressed to multiple sets (CTMS). Participants trained twice a week for 16 weeks. An incremental treadmill test and the one-repetition maximal test of knee extensors were performed before and after 8 and 16 weeks. Peak oxygen consumption showed similar increases from pre to post-16 weeks (AT: 9%, CTRE: 11%, CTMS: 5%). Oxygen consumption at the second ventilatory threshold and strength were increased from pre to post-8 weeks (AT: 15%, CTRE: 16%, CTMS: 3% and AT: 9%, CTRE: 5%, CTMS: 9%, respectively) and from post-8 to post-16 weeks (AT: 6%, CTRE: 3%, CTMS: 12% and AT: 4%, CTRE: 8%, CTMS: 4%, respectively). In conclusion, the three training programs promoted similar increases in the cardiorespiratory capacity and WAT promoted similar strength gains as WCT in short and long terms. Moreover, the use of resistive equipment and the increase in the number of sets are effective progression strategies.",2020,Peak oxygen consumption showed similar increases from pre to post-16 weeks,"['older women', 'Fifty-seven participants', 'older women in short and long-terms']","['aerobic training (AT); 2) concurrent training whose resistance training progressed to the use of resistive equipment (CTRE); and 3) concurrent training whose resistance training progressed to multiple sets (CTMS', 'CTMS', 'three water-based training', 'water-based aerobic and concurrent training', 'water-based aerobic training (WAT']","['cardiorespiratory capacity and strength', 'Peak oxygen consumption', 'Oxygen consumption', 'strength gains']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0661732', 'cui_str': 'cyclohexane-1,2,4-tris(methylenesulfonate)'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",57.0,0.0184618,Peak oxygen consumption showed similar increases from pre to post-16 weeks,"[{'ForeName': 'Thaís', 'Initials': 'T', 'LastName': 'Reichert', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. Electronic address: thais_reichert@hotmail.com.'}, {'ForeName': 'Rochelle Rocha', 'Initials': 'RR', 'LastName': 'Costa', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Artur Avelino Birk', 'Initials': 'AAB', 'LastName': 'Preissler', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Henrique Bianchi', 'Initials': 'HB', 'LastName': 'Oliveira', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Cláudia Gomes', 'Initials': 'CG', 'LastName': 'Bracht', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Bruna Machado', 'Initials': 'BM', 'LastName': 'Barroso', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Vitória', 'Initials': 'V', 'LastName': 'de Mello Bones da Rocha', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Andressa Freitas', 'Initials': 'AF', 'LastName': 'Correia', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Luiz Fernando Martins', 'Initials': 'LFM', 'LastName': 'Kruel', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2020.111103']
2963,33065273,Spinal manipulation and perineural electrical dry needling in patients with cervicogenic headache: a multi-center randomized clinical trial.,"BACKGROUND CONTEXT


Spinal manipulation, spinal mobilization and exercise are commonly used in individuals with cervicogenic headache (CH). Dry needling is being increasingly used in the management of CH. However, questions remain about the effectiveness of these therapies and how they compare to each other.
PURPOSE


The present study aims to compare the combined effects of spinal manipulation and dry needling with spinal mobilization and exercise on pain and disability in individuals with CH.
STUDY DESIGN/SETTING


Randomized, multi-center, parallel-group trial.
PATIENT SAMPLE


One hundred and forty-two patients (n=142) with CH from 13 outpatient clinics in 10 different states were recruited over a 36-month period.
OUTCOME MEASURES


The primary outcome was headache intensity as measured by the Numeric Pain Rating Scale (NPRS). Secondary outcomes included headache frequency and duration, disability (Neck Disability Index, NDI), medication intake, and the Global Rating of Change (GROC). Follow-up assessments were taken at 1 week, 4 weeks, and 3 months.
METHODS


Patients were randomized to receive upper cervical and upper thoracic spinal manipulation plus electrical dry needling (n=74) or upper cervical and upper thoracic spinal mobilization and exercise (n=68). In addition, the mobilization group also received a program of craniocervical and peri-scapular resistance exercises; whereas, the spinal manipulation group also received up to 8 sessions of perineural electrical dry needling. The treatment period for both groups was 4 weeks. None of the authors received any funding for this study. The trial was prospectively registered at ClinicalTrials.gov (NCT02373605). The authors declare no conflicts of interest.
RESULTS


The 2 × 4 ANCOVA revealed that individuals with CH who received thrust spinal manipulation and electrical dry needling experienced significantly greater reductions in headache intensity (F=23.464; P<0.001), headache frequency (F=13.407; P<0.001) and disability (F=10.702; P<0.001) than those who received nonthrust mobilization and exercise at a 3-month follow-up. Individuals in the spinal manipulation and electrical dry needling group also experienced shorter duration of headaches (P<0.001) at 3 months. Based on the cutoff score of ≥+5 on the GROC, significantly (X 2 =54.840; P<0.001) more patients (n= 57, 77%) within the spinal manipulation and electrical dry needling group achieved a successful outcome compared to the mobilization and exercise group (n=10, 15%) at 3 months follow-up. Between-groups effect sizes were large (0.94<SMD<1.25) in all outcomes in favor of the spinal manipulation and electrical dry needling group at 3 months. In addition, significantly (X 2 =29.889; P<0.001) more patients in the spinal manipulation and electrical dry needling group (n=49, 66%) completely stopped taking medication for their pain compared to the spinal mobilization and exercise group (n=14, 21%) at 3 months.
CONCLUSION


Upper cervical and upper thoracic high-velocity low-amplitude thrust spinal manipulation and electrical dry needling were shown to be more effective than nonthrust mobilization and exercise in patients with CH, and the effects were maintained at 3 months.",2020,Individuals in the spinal manipulation and electrical dry needling group also experienced shorter duration of headaches (P<0.001) at 3 months.,"['One hundred and forty-two patients (n=142) with CH from 13 outpatient clinics in 10 different states were recruited over a 36-month period', 'Patients', 'individuals with cervicogenic headache (CH', 'patients with cervicogenic headache', 'individuals with CH']","['spinal manipulation and dry needling with spinal mobilization and exercise', 'program of craniocervical and peri-scapular resistance exercises', 'upper cervical and upper thoracic spinal manipulation plus electrical dry needling (n=74) or upper cervical and upper thoracic spinal mobilization and exercise', 'spinal manipulation group also received up to 8 sessions of perineural electrical dry needling', 'Spinal manipulation and perineural electrical dry needling', 'Upper cervical and upper thoracic high-velocity low-amplitude thrust spinal manipulation and electrical dry needling']","['headache frequency and duration, disability (Neck Disability Index, NDI), medication intake, and the Global Rating of Change (GROC', 'successful outcome', 'headache intensity as measured by the Numeric Pain Rating Scale (NPRS', 'headache intensity', 'pain and disability', 'shorter duration of headaches', 'disability', 'headache frequency']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458101', 'cui_str': 'Cervicogenic headache'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1563705', 'cui_str': 'Diabetes Insipidus, Nephrogenic, Type I'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}]",142.0,0.0608483,Individuals in the spinal manipulation and electrical dry needling group also experienced shorter duration of headaches (P<0.001) at 3 months.,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dunning', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain; American Academy of Manipulative Therapy Fellowship in Orthopaedic Manual Physical Therapy, Montgomery, Alabama, United States of America. Electronic address: j.dunning.2016@alumnos.urjc.es.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Butts', 'Affiliation': 'American Academy of Manipulative Therapy Fellowship in Orthopaedic Manual Physical Therapy, Montgomery, Alabama, United States of America; Research Physical Therapy Specialists, Columbia, South Carolina, United States of America.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Zacharko', 'Affiliation': 'Physical Therapy of the Carolinas, Fort Mill, SC, United States of America.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Fandry', 'Affiliation': 'Back in Action Physical Therapy, Scottsdale, Arizona, United States of America.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Young', 'Affiliation': 'American Academy of Manipulative Therapy Fellowship in Orthopaedic Manual Physical Therapy, Montgomery, Alabama, United States of America; CORA Physical Therapy, Savannah, Georgia, United States of America.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Wheeler', 'Affiliation': 'ClearCut ORTHO, Fort Worth, Texas, United States of America.'}, {'ForeName': 'Jennell', 'Initials': 'J', 'LastName': 'Day', 'Affiliation': 'Peak Physical Therapy & Sports Rehab, Helena, Montana, United States of America.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain; Cátedra de Clínica, Investigación y Docencia en Fisioterapia: Terapia Manual, Punción Seca y Ejercicio, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.10.008']
2964,33065275,Vitamin D and survival in COVID-19 patients: A quasi-experimental study.,"Vitamin D may be a central biological determinant of COVID-19 outcomes. The objective of this quasi-experimental study was to determine whether bolus vitamin D3 supplementation taken during or just before COVID-19 was effective in improving survival among frail elderly nursing-home residents with COVID-19. Sixty-six residents with COVID-19 from a French nursing-home were included in this quasi-experimental study. The ""Intervention group"" was defined as those having received bolus vitamin D3 supplementation during COVID-19 or in the preceding month, and the ""Comparator group"" corresponded to all other participants. The primary and secondary outcomes were COVID-19 mortality and Ordinal Scale for Clinical Improvement (OSCI) score in acute phase, respectively. Age, gender, number of drugs daily taken, functional abilities, albuminemia, use of corticosteroids and/or hydroxychloroquine and/or antibiotics (i.e., azithromycin or rovamycin), and hospitalization for COVID-19 were used as potential confounders. The Intervention (n = 57; mean ± SD, 87.7 ± 9.3years; 79%women) and Comparator (n = 9; mean,87.4 ± 7.2years; 67%women) groups were comparable at baseline, as were the COVID-19 severity and the use of dedicated COVID-19 drugs. The mean follow-up time was 36 ± 17days. 82.5% of participants in the Intervention group survived COVID-19, compared to only 44.4% in the Comparator group (P = 0.023). The full-adjusted hazard ratio for mortality according to vitamin D3 supplementation was HR = 0.11[95%CI:0.03;0.48],P = 0.003. Kaplan-Meier distributions showed that Intervention group had longer survival time than Comparator group (log-rank P = 0.002). Finally, vitamin D3 supplementation was inversely associated with OSCI score for COVID-19 (β=-3.84[95%CI:-6.07;-1.62], P = 0.001). In conclusion, bolus vitamin D3 supplementation during or just before COVID-19 was associated in frail elderly with less severe COVID-19 and better survival rate.",2020,Kaplan-Meier distributions showed that Intervention group had longer survival time than Comparator group (log-rank P = 0.002).,"['frail elderly nursing-home residents with COVID-19', 'COVID-19 patients', 'Sixty-six residents with COVID-19 from a French nursing-home were included in this quasi-experimental study']","['corticosteroids and/or hydroxychloroquine and/or antibiotics (i.e., azithromycin or rovamycin', 'vitamin D3 supplementation', 'Vitamin D', 'bolus vitamin D3 supplementation']","['longer survival time', 'COVID-19 mortality and Ordinal Scale for Clinical Improvement (OSCI) score', 'survival rate', 'survival', 'Vitamin D and survival', 'OSCI score']","[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0878223', 'cui_str': 'Rovamycin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",66.0,0.0876815,Kaplan-Meier distributions showed that Intervention group had longer survival time than Comparator group (log-rank P = 0.002).,"[{'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Annweiler', 'Affiliation': 'Department of Geriatric Medicine and Memory Clinic, Research Center on Autonomy and Longevity, University Hospital, Angers, France; UPRES EA 4638, University of Angers, Angers, France; Robarts Research Institute, Department of Medical Biophysics, Schulich School of Medicine and Dentistry, the University of Western Ontario, London, ON, Canada. Electronic address: Cedric.Annweiler@chu-angers.fr.'}, {'ForeName': 'Bérangère', 'Initials': 'B', 'LastName': 'Hanotte', 'Affiliation': 'Department of Clinical Gerontology, University Hospital of Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Claire Grandin', 'Initials': 'CG', 'LastName': ""de l'Eprevier"", 'Affiliation': 'Geriatric hospital of Saint Laurent de Chamousset, Saint Laurent de Chamousset, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Sabatier', 'Affiliation': 'Université Aix-Marseille, Institut de Neuro-physiopathologie (INP), UMR 7051, Faculté de Pharmacie, 27 Bd Jean Moulin, 13385, Marseille Cedex, France.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Lafaie', 'Affiliation': 'Department of Clinical Gerontology, University Hospital of Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Célarier', 'Affiliation': 'Department of Clinical Gerontology, University Hospital of Saint-Etienne, Saint-Etienne, France; Chaire Santé des Ainés, University of Jean Monnet, Saint-Etienne, France; Gérontopôle Auvergne-Rhône-Alpes, Saint-Etienne, France.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2020.105771']
2965,33065302,Antimicrobial capacity of photodynamic therapy on oral health-related quality of life and halitosis among elderly patients wearing removal dentures.,"PURPOSE


The aim of the present clinical trial was to evaluate the efficacy of antimicrobial photodynamic therapy (PDT) for the treatment of halitosis in elderly patients wearing dentures.
METHODS


Elderly patients (>60 years age) wearing complete dentures and diagnosed with halitosis (H 2 S levels >112 ppb) were divided into two groups: patients undergoing treatment with tongue scraper and full mouth disinfection (Group I) and patients undergoing treatment with tongue scraper, full mouth disinfection and single application of PDT (Group II). Oral health related quality of life (OHRQoL) was assessed using a 14-point Likert scale used in oral health impact profile (OHIP). The assessment of halitosis was done with the help of a device called Oral Chroma TM . Microbial sampling for detection of Porphyromonas gingivalis (P. gingivalis) was performed from the dorsum of the tongue using a sterile swab at baseline and after treatment on day 5, 15 and 30 and quantified using polymerase chain reaction.
RESULTS


Forty elderly patients with halitosis completed the trial. The mean age in Group I and Group II was estimated to be 66.42 years and 67.91 years, respectively. Group II participants also maintained good OHRQoL in the post-operative period that reported statistically significant difference when compared with the control group (p < 0.01). Group II showed significant improvement in H 2 S concentration values at final analysis compared to Group-I (p = 0.001). P. gingivalis showed statistically significant reduction on day 5 only with PDT in Group II (p < 0.05).
CONCLUSION


Antimicrobial PDT helped in reducing H 2 S gas concentration and improving quality of life in elderly patients wearing dentures. A significant reduction of P. gingivalis occurred only in the short-term follow-up.",2020,"P. gingivalis showed statistically significant reduction on day 5 only with PDT in Group II (p < 0.05).
","['Elderly patients (>60 years age) wearing complete dentures and diagnosed with halitosis (H 2 S levels', 'elderly patients wearing dentures', '112\u2009ppb) were divided into two groups: patients undergoing treatment with', 'elderly patients wearing removal dentures', 'Forty elderly patients with halitosis completed the trial']","['Antimicrobial PDT', 'tongue scraper and full mouth disinfection (Group I) and patients undergoing treatment with tongue scraper, full mouth disinfection and single application of PDT', 'photodynamic therapy', 'antimicrobial photodynamic therapy (PDT']","['H 2 S concentration values', 'Oral health related quality of life (OHRQoL', 'oral health-related quality of life and halitosis', 'P. gingivalis', 'H 2 S gas concentration and improving quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018520', 'cui_str': 'Breath smells unpleasant'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0032441', 'cui_str': 'Polybrominated biphenyl'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018520', 'cui_str': 'Breath smells unpleasant'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",40.0,0.0462562,"P. gingivalis showed statistically significant reduction on day 5 only with PDT in Group II (p < 0.05).
","[{'ForeName': 'Nawaf', 'Initials': 'N', 'LastName': 'Labban', 'Affiliation': 'Department of Prosthetic Dental Sciences, King Saud University, College of Dentistry, P. O. Box 60169, Riyadh 11545, Saudi Arabia. Electronic address: labbannawaf@gmail.com.'}, {'ForeName': 'Mansour K', 'Initials': 'MK', 'LastName': 'Assery', 'Affiliation': 'Department of Prosthodontics, Riyadh Elm University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Al-Kattan', 'Affiliation': 'Department of Periodontics and Community Dentistry, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Nouf', 'Initials': 'N', 'LastName': 'Al-Shibani', 'Affiliation': 'Department of Periodontics and Community Dentistry, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Afnan F', 'Initials': 'AF', 'LastName': 'Alfouzan', 'Affiliation': 'Department of Prosthetic Dental Sciences, King Saud University, College of Dentistry, P. O. Box 60169, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Sara Mohammad', 'Initials': 'SM', 'LastName': 'Al Taweel', 'Affiliation': 'Department of Prosthetic Dental Sciences, King Saud University, College of Dentistry, P. O. Box 60169, Riyadh 11545, Saudi Arabia.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.102059']
2966,33065307,Two vs one forward view examination of right colon on adenoma detection: an international multicenter randomized trial.,"BACKGROUND AND AIMS


Second forward view (SFV) examination of right colon (RC) in colonoscopy was suggested to improve adenoma detection rate (ADR), but multicenter data to inform its routine use remain limited. We performed an international multicenter randomized trial comparing SFV versus standard single forward view examination of RC on adenoma detection.
METHODS


Asymptomatic individuals undergoing screening or surveillance colonoscopies from 6 Asia Pacific regions were invited for study. A forward view examination of RC was first performed in all patients, followed by randomization at hepatic flexure to either SFV examination of RC and standard withdrawal examination from hepatic flexure to rectum, or a standard withdrawal colonoscopy (SWC) examination from hepatic flexure to rectum. Primary outcome was RC ADR.
RESULTS


Between 2016 and 2019, 1011 patients were randomized (SFV group: 502, SWC group: 509). Forty-five endoscopists performed the colonoscopies. The RC ADR was significantly higher in the SFV group than the SWC group (27.1% vs 21.6%, p=0.042). The whole-colon ADR were high in both groups (49.0% vs 45.0%, p=0.201). SFV examination identified 58 additional adenomas in 49 patients (9.8%), leading to a change in surveillance recommendation in 15 patients (3.0%). The median overall withdrawal time was 1.5 minute longer in the SFV group (12.0 vs 10.5 minutes, p<0.001). Older age, male gender, ever smoking, and longer RC withdrawal time were independent predictors of right-sided adenoma detection.
CONCLUSION


In this multicenter trial, SFV examination significantly increased RC ADR in screening and surveillance colonoscopies. Routine RC SFV examination should be considered. ClinicalTrials.gov ID: NCT03121495.",2020,"The RC ADR was significantly higher in the SFV group than the SWC group (27.1% vs 21.6%, p=0.042).","['Asymptomatic individuals undergoing screening or surveillance colonoscopies from 6 Asia Pacific regions were invited for study', 'Between 2016 and 2019', '1011 patients were randomized']","['SFV', 'SWC']","['adenoma detection', 'whole-colon ADR', 'RC ADR', 'median overall withdrawal time']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450317', 'cui_str': '1011'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C4551463', 'cui_str': 'Colon adenoma'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",1011.0,0.162149,"The RC ADR was significantly higher in the SFV group than the SWC group (27.1% vs 21.6%, p=0.042).","[{'ForeName': 'Raymond S Y', 'Initials': 'RSY', 'LastName': 'Tang', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Jonathan W J', 'Initials': 'JWJ', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Hospital and National University of Singapore, Singapore.'}, {'ForeName': 'Li-Chun', 'Initials': 'LC', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'David E H', 'Initials': 'DEH', 'LastName': 'Ong', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Hospital and National University of Singapore, Singapore.'}, {'ForeName': 'Han-Mo', 'Initials': 'HM', 'LastName': 'Chiu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Matsuda', 'Affiliation': 'Cancer Screening Center, Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hyun-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Wonju College of Medicine, Yonsei University, Korea.'}, {'ForeName': 'Masau', 'Initials': 'M', 'LastName': 'Sekiguchi', 'Affiliation': 'Cancer Screening Center, Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Rupert W', 'Initials': 'RW', 'LastName': 'Leong', 'Affiliation': 'Department of Gastroenterology, Concord Hospital, Sydney, Australia; Faculty of Medicine and Health, Macquarie University Hospital, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Andrew M Y', 'Initials': 'AMY', 'LastName': 'Ho', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Thomas Y T', 'Initials': 'TYT', 'LastName': 'Lam', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Yee Kit', 'Initials': 'YK', 'LastName': 'Tse', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'South Western Sydney Clinical School, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Khay-Guan', 'Initials': 'KG', 'LastName': 'Yeoh', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Hospital and National University of Singapore, Singapore.'}, {'ForeName': 'James Y W', 'Initials': 'JYW', 'LastName': 'Lau', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China; Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Joseph J Y', 'Initials': 'JJY', 'LastName': 'Sung', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China. Electronic address: jjysung@cuhk.edu.hk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.10.014']
2967,33065342,Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study.,"PURPOSE


In the MONALEESA-3 Phase III trial of patients with hormone receptor-positive human epidermal growth factor receptor-negative advanced breast cancer, ribociclib plus fulvestrant significantly improved progression-free survival (PFS) and overall survival (OS). Here, we present patient-reported outcomes from the trial, including health-related quality of life (HRQOL).
METHODS


Patients were randomized (2:1) to receive ribociclib plus fulvestrant or placebo plus fulvestrant. Time to definitive 10% deterioration (TTD) from baseline in HRQOL (global health status [GHS] from the EORTC QLQ-C30 questionnaire) and pain (BPI-SF questionnaire) were assessed using Kaplan-Meier estimates; a stratified Cox regression model was used to estimate the hazard ratio (HR) and 95% CIs.
RESULTS


Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (HR for TTD ≥ 10% = 0.81 [95% CI, 0.62-1.1]). Similar findings were noted for TTD ≥5% (HR = 0.79 [95% CI, 0.61-1.0]) and TTD ≥15% (HR = 0.81 [95% CI, 0.60-1.08]). TTD ≥10% in emotional functioning (HR = 0.76 [95% CI, 0.57-1.01]) trended in favor of the ribociclib group, whereas results for fatigue and pain were similar between arms. TTD ≥10% in BPI-SF pain severity index score (HR = 0.77 [95% CI, 0.57-1.05]) and worst pain item score (HR = 0.81 [95% CI, 0.58-1.12]) trended in favor of ribociclib vs placebo.
CONCLUSIONS


In addition to significantly prolonging PFS and OS compared with placebo plus fulvestrant, adding ribociclib to fulvestrant maintains HRQOL.",2020,"RESULTS


Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (","['Patients', 'reference) group ', 'advanced breast cancer', 'patients with hormone receptor-positive human epidermal growth factor receptor-negative advanced breast cancer']","['ribociclib plus fulvestrant or placebo plus fulvestrant', 'Ribociclib plus fulvestrant', 'placebo', 'ribociclib plus fulvestrant', 'ribociclib', 'placebo plus fulvestrant']","['worst pain item score', 'progression-free survival (PFS) and overall survival (OS', 'BPI-SF pain severity index score', 'Time to definitive 10% deterioration (TTD) from baseline in HRQOL (global health status [GHS] from the EORTC QLQ-C30 questionnaire) and pain (BPI-SF questionnaire', 'health-related quality of life (HRQOL', 'fatigue and pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4087185', 'cui_str': 'Human epidermal growth factor receptor negative'}]","[{'cui': 'C4045494', 'cui_str': 'ribociclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.436342,"RESULTS


Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany. Electronic address: peter.fasching@uk-erlangen.de.'}, {'ForeName': 'J Thaddeus', 'Initials': 'JT', 'LastName': 'Beck', 'Affiliation': 'Highlands Oncology Group, Fayetteville, AR, USA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Breast Cancer Research Centre-Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale"", Naples, Italy.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Esteva', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Jerusalem', 'Affiliation': 'CHU de Liège, University of Liège, Liège, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'Multidisciplinary Breast Centre, Universitair Ziekenhuis Leuven, Leuven, Belgium.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pivot', 'Affiliation': 'Institut Régional Du Cancer, Strasbourg, France.'}, {'ForeName': 'Giulia V', 'Initials': 'GV', 'LastName': 'Bianchi', 'Affiliation': 'Fondazione IRCCS - Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Instituto de Investigación Sanitaria Gregorio Marañón, Ciberonc Geicam, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chandiwana', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Lanoue', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Ridolfi', 'Affiliation': 'Novartis Pharma SAS, Rueil-Malmaison, France.'}, {'ForeName': 'Yingbo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rodriguez Lorenc', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Arnd', 'Initials': 'A', 'LastName': 'Nusch', 'Affiliation': 'Practice for Haematology and Internal Oncology, Velbert, Germany.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.09.008']
2968,33065408,Biomarker-enhanced VTE risk stratification in ambulatory patients with cancer.,"INTRODUCTION


Risk assessment models are used to stratify cancer patients according to their underlying risk of VTE. The CATS score has been shown to enhance VTE risk stratification as compared to the modified Khorana score by incorporating d-dimer and soluble p-selectin measurements. Our aim was to evaluate the performance of the CATS score with respect to VTE risk stratification.
MATERIALS AND METHODS


Analysis of a subset of the AVERT trial population for whom biomarker data was available. All patients included in the AVERT trial were at increased risk of VTE based on a modified Khorana score of ≥2. Patients were stratified according to the modified Khorana score and CATS score. Kaplan-Meier analysis was used to calculate the 6-month cumulative probabilities of VTE.
RESULTS


A total of 466 patients were included in the analysis, 229 and 237 patients in the placebo and apixaban arms, respectively. The 6-month cumulative probability of VTE among patients with a modified Khorana score ≥ 3 was 13% [95% CI 7 to 23], whereas it was 20% [95% CI 11 to 35] for patients with a CATS score ≥ 4. The absolute risk reduction achieved with apixaban VTE prophylaxis among patients with modified Khorana ≥2, modified Khorana ≥3 and CATS ≥4 was -5.9% [-10.9 to -0.8], -5.8% [-16.0 to 4.5] and -10.1% [-22.9 to 2.6], respectively. Apixaban VTE prophylaxis among patients with increasing modified Khorana or CATS scores was not associated with an increased risk of bleeding events.
CONCLUSIONS


The use of a CATS score of ≥4 to identify ambulatory cancer patients at very high risk of VTE could enhance the benefit/risk ratio achieved with apixaban VTE prophylaxis.",2020,"Apixaban VTE prophylaxis among patients with increasing modified Khorana or CATS scores was not associated with an increased risk of bleeding events.
","['ambulatory patients with cancer', 'ambulatory cancer patients at very high risk of VTE', 'Analysis of a subset of the AVERT trial population for whom biomarker data was available', '466 patients were included in the analysis, 229 and 237 patients in the']",['placebo and apixaban'],"['risk of bleeding events', '6-month cumulative probability of VTE', 'modified Khorana or CATS scores', 'modified Khorana score and CATS score', 'risk of VTE']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",466.0,0.0562162,"Apixaban VTE prophylaxis among patients with increasing modified Khorana or CATS scores was not associated with an increased risk of bleeding events.
","[{'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Shaw', 'Affiliation': 'Department of Medicine, University of Ottawa, and the Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, United States; University of North Carolina Blood Research Center.'}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Department of Medicine, University of Ottawa, and the Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': 'Department of Medicine, University of Ottawa, and the Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Ilich', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, United States; University of North Carolina Blood Research Center.'}, {'ForeName': 'Nigel S', 'Initials': 'NS', 'LastName': 'Key', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, United States; University of North Carolina Blood Research Center.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Wells', 'Affiliation': 'Department of Medicine, University of Ottawa, and the Ottawa Hospital Research Institute, Ottawa, Canada. Electronic address: pwells@toh.ca.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.035']
2969,33065448,"Effectiveness of a home-based early cognitive-motor intervention provided in daycare, home care, and foster care settings: Changes in motor development and context affordances.","BACKGROUND


Appropriate opportunities within the context are crucial to affect the motor trajectory positively.
OBJECTIVE


To investigate the effectiveness of professional-parental/caregivers' early motor-cognitive intervention on infants' motor development in Daycare (DC), Home Care (HC), and Foster Care (FC). Secondary objectives were to examine if parents and caregivers modified the context to meet the infants' needs and if making modifications was positively associated with infants' development.
METHODS


Participants were 176 infants (DC = 48; HC = 58, FC = 70). Infants' were randomly assigned to intervention (IG) or comparison (CG) groups within each context. The Alberta Infant Motor Scale and Affordances in the Daycare and Home Environment for Motor Development were used. A cognitive-motor intervention was provided for infants in the intervention groups; and, a home-based support protocol for all caregivers and parents.
RESULTS


IGs showed higher motor scores at post-test than CGs (p values from 0.018 to 0.026) and positive changes were observed from the pre-to-post intervention for all IGs (p ≤ .0001), and for two CGs (DC p ≤ .0001; HC p = .028). Maternal daily care and home opportunities improved for all infants.
CONCLUSIONS


Parents/caregivers' protocol combined with the cognitive-motor intervention lead to better motor outcomes and changes in the context for the IGs. Only the parent/caregivers' protocol was not strong to improve CGs motor outcomes, although changes in context were found. Intensive intervention is need for infants living in vulnerability.",2020,"RESULTS


IGs showed higher motor scores at post-test than CGs (p values from 0.018 to 0.026) and positive changes were observed from the pre-to-post intervention for all IGs (p ≤ .0001), and for two CGs (DC p ≤ .0001; HC p = .028).","['Infants', 'infants living in vulnerability', 'Participants were 176 infants (DC\xa0=\xa048; HC\xa0=\xa058, FC\xa0=\xa070']","['cognitive-motor intervention', 'intervention (IG) or comparison (CG', ""professional-parental/caregivers' early motor-cognitive intervention"", 'home-based early cognitive-motor intervention', 'Intensive intervention']","['Maternal daily care and home opportunities', ""infants' motor development in Daycare (DC), Home Care (HC), and Foster Care (FC"", 'CGs motor outcomes', 'motor scores']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",176.0,0.0591172,"RESULTS


IGs showed higher motor scores at post-test than CGs (p values from 0.018 to 0.026) and positive changes were observed from the pre-to-post intervention for all IGs (p ≤ .0001), and for two CGs (DC p ≤ .0001; HC p = .028).","[{'ForeName': 'Nadia Cristina', 'Initials': 'NC', 'LastName': 'Valentini', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, UFRGS, Department of Physical Education, Physiotherapy and Dance, Porto Alegre, Rio Grande do Sul, Brazil. Electronic address: nadiacv@esef.ufrgs.br.'}, {'ForeName': 'Carla Skilhan', 'Initials': 'CS', 'LastName': 'de Almeida', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, UFRGS, Department of Physical Education, Physiotherapy and Dance, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Smith', 'Affiliation': 'University of Southern California, Division of Biokinesiology and Physical Therapy, Los Angeles, CA, USA.'}]",Early human development,['10.1016/j.earlhumdev.2020.105223']
2970,33065472,Individual variation in alpha neurofeedback training efficacy predicts pain modulation.,"Studies have shown an association between sensorimotor α-oscillation and pain perception. It suggests the potential use of neurofeedback (NFB) training for pain modulation through modifying sensorimotor α-oscillation. Here, a single-session NFB training protocol targeted on increasing sensorimotor α-oscillations was applied to forty-five healthy participants. Pain thresholds to nociceptive laser stimulations and pain ratings (intensity and unpleasantness) to identical laser painful stimulations were assessed immediately before and after NFB training. Participants had larger pain thresholds, but rated the identical painful laser stimulation as more unpleasant after NFB training. These pain measurements were further compared between participants with high or low NFB training efficacy that was quantified as the regression slope of α-oscillation throughout the ten training blocks. A significant increase in pain thresholds was observed among participants with high-efficacy; whereas a significant increase in pain ratings was observed among participants with low-efficacy. These results suggested that NFB training decreased the sensory-discriminative aspect of pain, but increased the affective-motivational aspect of pain, whereas both pain modulations were dependent upon the NFB training efficacy. Importantly, correlation analysis across all participants revealed that a greater NFB training efficacy predicted a greater increase in pain thresholds particularly at hand contralateral to NFB target site, but no significant correlation was observed between NFB training efficacy and modulation on pain ratings. It thus provided causal evidence for a link between sensorimotor α-oscillation and the sensory-discriminative aspect of pain, and highlighted the need for personalized neurofeedback for the benefits on pain modulation at the individual level. Future studies can adopt a double-blind sham-controlled protocol to validate NFB training induced pain modulation.",2020,Pain thresholds to nociceptive laser stimulations and pain ratings (intensity and unpleasantness) to identical laser painful stimulations were assessed immediately before and after NFB training.,['forty-five healthy participants'],"['neurofeedback (NFB) training', 'NFB training']","['pain ratings', 'affective-motivational aspect of pain', 'NFB training efficacy', 'larger pain thresholds', 'NFB training efficacy and modulation on pain ratings', 'pain thresholds', 'pain modulations', 'pain measurements', 'pain modulation', 'pain ratings (intensity and unpleasantness', 'sensory-discriminative aspect of pain']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}]",45.0,0.0367678,Pain thresholds to nociceptive laser stimulations and pain ratings (intensity and unpleasantness) to identical laser painful stimulations were assessed immediately before and after NFB training.,"[{'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Psychology, Shanghai Normal University, Shanghai, China.'}, {'ForeName': 'Wenya', 'Initials': 'W', 'LastName': 'Nan', 'Affiliation': 'Department of Psychology, Shanghai Normal University, Shanghai, China. Electronic address: wynan1985@126.com.'}, {'ForeName': 'Roi Cohen', 'Initials': 'RC', 'LastName': 'Kadosh', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wan', 'Affiliation': 'Department of Electrical and Computer Engineering, Faculty of Science and Technology, University of Macau, Macau, China; Centre for Cognitive and Brain Sciences, Institute of Collaborative Innovation, University of Macau, Macau, China.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102454']
2971,31145185,Reengineering Skilled Nursing Facility Discharge: Analysis of Reengineered Discharge Implementation.,"BACKGROUND


There is a need to adopt evidence-based approaches to discharge planning in the skilled nursing facility (SNF) short stay population.
PURPOSE


This article describes implementation of the Reengineered Discharge (RED) process in SNFs and makes recommendations for its future implementation.
METHODS


The methods included a pre- and postanalysis of an 18-month RED implementation with a contemporaneous comparison of 4 Midwestern SNFs randomly assigned to 2 different RED implementation strategies. The Standard facilities received less implementation than Enhanced facilities.
RESULTS


Standard SNFs made more improvements and were more satisfied with the improved process than Enhanced SNFs. Field notes revealed that corporate willingness to make process changes impacted the Standard group's capacity for change; both groups were heavily influenced by external forces, and turnover was an impediment to RED implementation.
CONCLUSION


This research revealed that discharge processes are similar across settings and that evidence-based programs such as RED can be adapted to the SNF setting.",2020,"Field notes revealed that corporate willingness to make process changes impacted the Standard group's capacity for change; both groups were heavily influenced by external forces, and turnover was an impediment to RED implementation.
",[],[],[],[],[],[],,0.0574187,"Field notes revealed that corporate willingness to make process changes impacted the Standard group's capacity for change; both groups were heavily influenced by external forces, and turnover was an impediment to RED implementation.
","[{'ForeName': 'Lori L', 'Initials': 'LL', 'LastName': 'Popejoy', 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia (Drs Popejoy, Wakefield, Vogelsmeier and Ms Huneke); Helen Bader School of Social Work, Milwaukee, Wisconsin (Dr Galambos); School of Social Work, Columbia, Missouri (Ms Lewis); Office of Medical Research, University of Missouri, Columbia (Dr Petroski); and Department of Family and Community Medicine, University of Missouri, Columbia (Dr Mehr). Ms Huneke is now with the Family Health Center, Columbia, Missouri.'}, {'ForeName': 'Bonnie J', 'Initials': 'BJ', 'LastName': 'Wakefield', 'Affiliation': ''}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Vogelsmeier', 'Affiliation': ''}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Galambos', 'Affiliation': ''}, {'ForeName': 'Alexandria M', 'Initials': 'AM', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Huneke', 'Affiliation': ''}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Petroski', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Mehr', 'Affiliation': ''}]",Journal of nursing care quality,['10.1097/NCQ.0000000000000413']
2972,31058286,Non-pharmacological Considerations in Human Research of Nicotine and Tobacco Effects: A Review.,"Human research of nicotine and tobacco effects demonstrates that non-pharmacological factors may systematically affect responses to administered substances and inert placebos. Failure to measure or manipulate these factors may compromise study reliability and validity. This is especially relevant for double-blind placebo-controlled research of nicotine, tobacco, and related substances. In this article, we review laboratory-based human research of the impact of non-pharmacological factors on responses to tobacco and nicotine administration. Results suggest that varying beliefs about drug content and effects, perceptions about drug use opportunities, and intentions to cease drug use systematically alter subjective, behavioral, and physiological responses to nicotine, tobacco, and placebo administration. These non-pharmacological factors should be considered when designing and interpreting the findings of human research of nicotine and tobacco effects, particularly when a double-blind placebo-controlled design is used. The clinical implications of these findings are discussed, and we propose methodological strategies to enhance the reliability and validity of future research.
IMPLICATIONS


Growing research demonstrates that non-pharmacological factors systematically alter responses to acute nicotine, tobacco, and placebo administration. Indeed, varying beliefs about nicotine and/or tobacco administration and effects, differing perceptions about nicotine and/or tobacco use opportunities, and inconsistent motivation to quit smoking have been found to exert important influences on subjective, physiological, and behavioral responses. These variables are infrequently measured or manipulated in nicotine and tobacco research, which compromises the validity of study findings. Incorporating methodological strategies to better account for these non-pharmacological factors has the potential to improve the quality of addiction research and treatment.",2020,"Results suggest that varying beliefs about drug content and effects, perceptions about drug use opportunities, and intentions to cease drug use systematically alter subjective, behavioural, and physiological responses to nicotine, tobacco, and placebo administration.",[],[],[],[],[],[],,0.0672145,"Results suggest that varying beliefs about drug content and effects, perceptions about drug use opportunities, and intentions to cease drug use systematically alter subjective, behavioural, and physiological responses to nicotine, tobacco, and placebo administration.","[{'ForeName': 'Hera E', 'Initials': 'HE', 'LastName': 'Schlagintweit', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Robin N', 'Initials': 'RN', 'LastName': 'Perry', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Darredeau', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Barrett', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, Nova Scotia, Canada.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz064']
2973,32067251,Randomized Controlled Trial of a Multilevel Intervention to Address Social Determinants of Refugee Mental Health.,"Understanding processes that support the well-being of the unprecedented numbers of forcibly displaced people throughout the world is essential. Growing evidence documents post-migration stressors related to marginalization as key social determinants of refugee mental health. The goal of this RCT was to rigorously test a social justice approach to reducing high rates of distress among refugees in the United States. The 6-month multilevel, strengths-based Refugee Well-being Project (RWP) intervention brought together university students enrolled in a 2-semester course and recently resettled refugees to engage in mutual learning and collaborative efforts to mobilize community resources and improve community and systems responsiveness to refugees. Data collected from 290 Afghan, Great Lakes African, Iraqi, and Syrian refugees at four time points over 12 months were used to test the effectiveness of RWP to reduce distress (depression and anxiety symptoms) and increase protective factors (English proficiency, social support, connection to home and American cultures). Intention-to-treat analyses using multilevel modeling revealed significant intervention effects for all hypothesized outcomes. Results provide evidence to support social justice approaches to improving refugee mental health. Findings have implications for refugees worldwide, and for other immigrant and marginalized populations who experience inequities in resources and disproportionate exposure to trauma/stress.",2020,Understanding processes that support the well-being of the unprecedented numbers of forcibly displaced people throughout the world is essential.,[],"['RWP', 'strengths-based Refugee Well-being Project (RWP) intervention', 'Multilevel Intervention']","['protective factors (English proficiency, social support, connection to home and American cultures', 'distress (depression and anxiety symptoms']",[],"[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}]","[{'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0037438'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.0395065,Understanding processes that support the well-being of the unprecedented numbers of forcibly displaced people throughout the world is essential.,"[{'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Goodkind', 'Affiliation': 'Department of Sociology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Bybee', 'Affiliation': 'Department of Psychology, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Julia Meredith', 'Initials': 'JM', 'LastName': 'Hess', 'Affiliation': 'Department of Pediatrics, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Suha', 'Initials': 'S', 'LastName': 'Amer', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ndayisenga', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'R Neil', 'Initials': 'RN', 'LastName': 'Greene', 'Affiliation': 'Department of Sociology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Ryeora', 'Initials': 'R', 'LastName': 'Choe', 'Affiliation': 'Department of Sociology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Isakson', 'Affiliation': 'Department of Psychiatry, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Baca', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Mahbooba', 'Initials': 'M', 'LastName': 'Pannah', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}]",American journal of community psychology,['10.1002/ajcp.12418']
2974,31982599,Home-based cycling using connected ergometric bicycles for people with lumbar spinal stenosis (FLEXCAL): Protocol for a randomised trial.,,2020,,['people with lumbar spinal stenosis (FLEXCAL'],['Home-based cycling using connected ergometric bicycles'],[],"[{'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region (disorder)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}]",[],,0.118468,,"[{'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Nguyen', 'Affiliation': ""UFR médecine de Paris Centre, faculté de santé, université de Paris, Sorbonne-Paris-Cité, 75006 Paris, France; Service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du Rachis, hôpital Cochin, AP-HP. Centre-Université de Paris, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France; INSERM UMRS-1124, toxicité environnementale, cibles thérapeutiques, signalisation cellulaire et biomarqueurs, centre universitaire des Saints-Pères, 75006 Paris, France. Electronic address: christelle.nguyen2@aphp.fr.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boutron', 'Affiliation': ""UFR médecine de Paris Centre, faculté de santé, université de Paris, Sorbonne-Paris-Cité, 75006 Paris, France; Centre d'épidémiologie clinique, hôpital Hôtel-Dieu, AP-HP. Centre-Université de Paris, 75004 Paris, France; INSERM UMRS-1153, centre de recherche épidémiologie et statistique Sorbonne Paris Cité, METHODS team, 75004 Paris, France.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Roren', 'Affiliation': ""Service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du Rachis, hôpital Cochin, AP-HP. Centre-Université de Paris, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France; INSERM UMRS-1153, centre de recherche épidémiologie et statistique Sorbonne Paris Cité, ECaMO team, 75004 Paris, France; Institut fédératif de recherche sur le handicap, 75013 Paris, France.""}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Baron', 'Affiliation': 'INSERM UMRS-1153, centre de recherche épidémiologie et statistique Sorbonne Paris Cité, METHODS team, 75004 Paris, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Pauwels', 'Affiliation': ""Service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du Rachis, hôpital Cochin, AP-HP. Centre-Université de Paris, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France.""}, {'ForeName': 'Marie-Martine', 'Initials': 'MM', 'LastName': 'Lefèvre-Colau', 'Affiliation': ""UFR médecine de Paris Centre, faculté de santé, université de Paris, Sorbonne-Paris-Cité, 75006 Paris, France; Service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du Rachis, hôpital Cochin, AP-HP. Centre-Université de Paris, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France; INSERM UMRS-1153, centre de recherche épidémiologie et statistique Sorbonne Paris Cité, ECaMO team, 75004 Paris, France; Institut fédératif de recherche sur le handicap, 75013 Paris, France.""}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Poiraudeau', 'Affiliation': ""UFR médecine de Paris Centre, faculté de santé, université de Paris, Sorbonne-Paris-Cité, 75006 Paris, France; Service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du Rachis, hôpital Cochin, AP-HP. Centre-Université de Paris, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France; INSERM UMRS-1153, centre de recherche épidémiologie et statistique Sorbonne Paris Cité, ECaMO team, 75004 Paris, France; Institut fédératif de recherche sur le handicap, 75013 Paris, France.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Dupeyron', 'Affiliation': 'Service de médecine physique et de réadaptation, hôpital universitaire Carémeau, CHU de Carémeau-Nîmes, 30000 Nîmes, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Coudeyre', 'Affiliation': 'Service de médecine physique et de réadaptation, INRA, centre hospitalo-universitaire de Clermont-Ferrand, université Clermont-Auvergne, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Rannou', 'Affiliation': ""UFR médecine de Paris Centre, faculté de santé, université de Paris, Sorbonne-Paris-Cité, 75006 Paris, France; Service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du Rachis, hôpital Cochin, AP-HP. Centre-Université de Paris, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France; INSERM UMRS-1124, toxicité environnementale, cibles thérapeutiques, signalisation cellulaire et biomarqueurs, centre universitaire des Saints-Pères, 75006 Paris, France.""}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2019.12.006']
2975,31709816,Supplementation With Vitamin D and Omega-3 Fatty Acids and Incidence of Heart Failure Hospitalization: VITAL-Heart Failure.,,2020,"Vitamin D and marine omega-3 (n-3) fatty acids have each been associated with reduced risks of HF in observational studies, but randomized trial evidence is limited.","['older adults, heart failure (HF', '36 participants with prevalent HF for current analyses', 'cardiovascular disease and cancer in 25, 871 adults from 2011 to 2017']","['Vitamin D and marine omega-3 (n-3) fatty acids', 'vitamin D 3  (2000 IU/d) and n-3 fatty acids (1 gram per day, including eicosapentaenoic acid [EPA, 460 mg] + docosahexaenoic acid [DHA, 380 mg', 'Vitamin D and/or Omega-3 Fatty Acids', 'vitamin D and n-3 supplements']",['HF hospitalization'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",871.0,,"Vitamin D and marine omega-3 (n-3) fatty acids have each been associated with reduced risks of HF in observational studies, but randomized trial evidence is limited.","[{'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Djoussé', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (L.D., N.R.C., E.K., J.W., V. Bubes, H.L.-G., S.M., J.J., I.-M.L., C.M.A., J.E.B., J.M.G., J.E.M.).""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (L.D., N.R.C., E.K., J.W., V. Bubes, H.L.-G., S.M., J.J., I.-M.L., C.M.A., J.E.B., J.M.G., J.E.M.).""}, {'ForeName': 'Eunjung', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (L.D., N.R.C., E.K., J.W., V. Bubes, H.L.-G., S.M., J.J., I.-M.L., C.M.A., J.E.B., J.M.G., J.E.M.).""}, {'ForeName': 'Vijaykumar', 'Initials': 'V', 'LastName': 'Bodar', 'Affiliation': 'Louisiana State University, Shreveport (V. Bodar).'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Walter', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (L.D., N.R.C., E.K., J.W., V. Bubes, H.L.-G., S.M., J.J., I.-M.L., C.M.A., J.E.B., J.M.G., J.E.M.).""}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (L.D., N.R.C., E.K., J.W., V. Bubes, H.L.-G., S.M., J.J., I.-M.L., C.M.A., J.E.B., J.M.G., J.E.M.).""}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Luttmann-Gibson', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (L.D., N.R.C., E.K., J.W., V. Bubes, H.L.-G., S.M., J.J., I.-M.L., C.M.A., J.E.B., J.M.G., J.E.M.).""}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (L.D., N.R.C., E.K., J.W., V. Bubes, H.L.-G., S.M., J.J., I.-M.L., C.M.A., J.E.B., J.M.G., J.E.M.).""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Joseph', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (L.D., N.R.C., E.K., J.W., V. Bubes, H.L.-G., S.M., J.J., I.-M.L., C.M.A., J.E.B., J.M.G., J.E.M.).""}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (L.D., N.R.C., E.K., J.W., V. Bubes, H.L.-G., S.M., J.J., I.-M.L., C.M.A., J.E.B., J.M.G., J.E.M.).""}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Albert', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (L.D., N.R.C., E.K., J.W., V. Bubes, H.L.-G., S.M., J.J., I.-M.L., C.M.A., J.E.B., J.M.G., J.E.M.).""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (L.D., N.R.C., E.K., J.W., V. Bubes, H.L.-G., S.M., J.J., I.-M.L., C.M.A., J.E.B., J.M.G., J.E.M.).""}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Gaziano', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (L.D., N.R.C., E.K., J.W., V. Bubes, H.L.-G., S.M., J.J., I.-M.L., C.M.A., J.E.B., J.M.G., J.E.M.).""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (L.D., N.R.C., E.K., J.W., V. Bubes, H.L.-G., S.M., J.J., I.-M.L., C.M.A., J.E.B., J.M.G., J.E.M.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.044645']
2976,31167022,Families Improving Together (FIT) for weight loss: a resource for translation of a positive climate-based intervention into community settings.,"Climate-based weight loss interventions, or those that foster a nurturing family environment, address important ecological influences typically ignored by the traditional biomedical treatments. Promoting a climate characterized by positive communication, autonomy support, and parental warmth supports adolescents in making healthy behavioral changes. In addition, encouraging these skills within the family may have additional benefits of improved family functioning and other mental and physical health outcomes. Although several programs have identified essential elements and established the evidence base for the efficacy of these interventions, few have offered resources for the translation of these constructs from theoretical concepts to tangible practice. This paper provides strategies and resources utilized in the Families Improving Together (FIT) for weight loss randomized controlled trial to create a warm, supportive climate characterized by positive communication within the parent-child relationship. Detailed descriptions of how Project FIT emphasized these constructs through facilitator training, intervention curriculum, and process evaluation are provided as a resource for clinical and community interventions. Researchers are encouraged to provide resources to promote translation of evidence-based interventions for programs aiming to utilize a positive climate-based family approach for lifestyle modification.",2020,"In addition, encouraging these skills within the family may have additional benefits of improved family functioning and other mental and physical health outcomes.",[],[],[],[],[],[],,0.0428267,"In addition, encouraging these skills within the family may have additional benefits of improved family functioning and other mental and physical health outcomes.","[{'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Law', 'Affiliation': 'Department of Psychology, University of South Carolina, Columbia, SC.'}, {'ForeName': 'Dawn K', 'Initials': 'DK', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, University of South Carolina, Columbia, SC.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'St George', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Kitzman', 'Affiliation': 'Baylor Scott and White Health and Wellness Center, Dallas, TX.'}, {'ForeName': 'Colby J', 'Initials': 'CJ', 'LastName': 'Kipp', 'Affiliation': 'Department of Psychology, University of South Carolina, Columbia, SC.'}]",Translational behavioral medicine,['10.1093/tbm/ibz020']
2977,31707833,Stent Thrombosis in Patients With Atrial Fibrillation Undergoing Coronary Stenting in the AUGUSTUS Trial.,,2020,(acute coronary syndrome [ACS] or elective percutaneous coronary intervention [PCI]) and the randomized treatment effects of low-dose aspirin (compared with placebo) and apixaban (compared with vitamin K antagonist [VKA]) on the risk of stent thrombosis.,"['patients with atrial fibrillation (AF', 'patients with medically-managed ACS (n=1097) or an unknown qualifying index event (n=19', '1  who received a coronary stent during their qualifying admission', 'patients who received a stent during their qualifying admission', 'Patients with Atrial Fibrillation Undergoing Coronary Stenting in the AUGUSTUS Trial']","['placebo) and apixaban (compared with vitamin K antagonist [VKA', 'low-dose aspirin', 'elective percutaneous coronary intervention [PCI']",['Stent Thrombosis'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",,,(acute coronary syndrome [ACS] or elective percutaneous coronary intervention [PCI]) and the randomized treatment effects of low-dose aspirin (compared with placebo) and apixaban (compared with vitamin K antagonist [VKA]) on the risk of stent thrombosis.,"[{'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., D.M.W., L.T., C.B.G., J.H.A.).'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Leonardi', 'Affiliation': 'University of Pavia and Fondazione IRCCS Policlinico S. Matteo, Italy (S.L.).'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Wojdyla', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., D.M.W., L.T., C.B.G., J.H.A.).'}, {'ForeName': 'Amit N', 'Initials': 'AN', 'LastName': 'Vora', 'Affiliation': 'UPMC Pinnacle, Harrisburg, PA (A.N.V.).'}, {'ForeName': 'Laine', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., D.M.W., L.T., C.B.G., J.H.A.).'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'University of Sheffield, UK (R.F.S.).'}, {'ForeName': 'Dragos', 'Initials': 'D', 'LastName': 'Vinereanu', 'Affiliation': 'University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital of Bucharest, Romania (D.V.).'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., D.M.W., L.T., C.B.G., J.H.A.).'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada (S.G.G.).'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ (R.A.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Bern University Hospital, Inselspital, University of Bern, Switzerland (S.W., M.V.).'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at the University of Leipzig, Department of Internal Medicine/Cardiology and Leipzig Heart Institute, Germany (H.T.).'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Bern University Hospital, Inselspital, University of Bern, Switzerland (S.W., M.V.).'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.).'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., D.M.W., L.T., C.B.G., J.H.A.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.044584']
2978,32109313,The efficacy of ketamine for postoperative pain control in adolescent patients undergoing spinal fusion surgery for idiopathic scoliosis.,"The use of ketamine in conjunction with morphine to reduce postoperative pain has been explored in several different surgery subtypes with conflicting results. Ketamine has shown promise to have both opioid sparing and analgesic effects in the postoperative setting. This study aimed to elucidate ketamine's ability to reduce morphine equivalent consumption and improve patient satisfaction after spinal fusion surgery for the correction of idiopathic scoliosis. This surgery is known to be associated with significant postoperative pain which impedes the ability to improve patient satisfaction, and may complicate the recovery timeline. Currently, the standard therapeutic regimen consists of patient-controlled analgesia morphine and the use of other opioids such as hydromorphone. A prospective, randomized double-blinded, placebo-controlled trial was performed to compare the standard morphine equivalent therapy alone against a standard therapy in conjunction with ketamine. Fifty adolescent patients were enrolled and randomized. Results yielded a significant reduction in postoperative morphine equivalent consumption (p = 0.042), adjusted postoperative pain scores (p < 0.001), and incidence of nausea and vomiting (p = 0.045). The application of ketamine as an analgesic in conjunction with the current standard of morphine equivalent therapy may serve as a superior pain control regimen for spinal surgeries in young population. This regimen enhancement may be generalizable to other surgery subtypes within similar populations. LEVEL OF EVIDENCE: Level I.",2020,"Results yielded a significant reduction in postoperative morphine equivalent consumption (p = 0.042), adjusted postoperative pain scores (p < 0.001), and incidence of nausea and vomiting (p = 0.045).","['Fifty adolescent patients', 'spinal surgeries in young population', 'idiopathic scoliosis', 'adolescent patients undergoing spinal fusion surgery for idiopathic scoliosis']","['Ketamine', 'placebo', 'ketamine', 'hydromorphone', 'morphine']","['postoperative morphine equivalent consumption', 'nausea and vomiting', 'patient satisfaction', 'adjusted postoperative pain scores']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0595995', 'cui_str': 'Idiopathic scoliosis (disorder)'}, {'cui': 'C0919636', 'cui_str': 'Operative spinal fusion'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",50.0,0.218573,"Results yielded a significant reduction in postoperative morphine equivalent consumption (p = 0.042), adjusted postoperative pain scores (p < 0.001), and incidence of nausea and vomiting (p = 0.045).","[{'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Ricciardelli', 'Affiliation': 'Albany Medical College, Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Noah M', 'Initials': 'NM', 'LastName': 'Walters', 'Affiliation': 'Albany Medical College, Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Maxwill', 'Initials': 'M', 'LastName': 'Pomerantz', 'Affiliation': 'Albany Medical College, Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Metcalfe', 'Affiliation': 'Department of Anesthesiology, University of Michigan Hospitals and Health Centers, Ann Arbor, USA.'}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Afroze', 'Affiliation': 'Department of Anesthesiology, Albany Medical Center, Albany, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Ehlers', 'Affiliation': 'Department of Anesthesiology, Albany Medical Center, Albany, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Leduc', 'Affiliation': 'Department of Anesthesiology, GHS Greenville Memorial Hospital, Greenville, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Feustel', 'Affiliation': 'Albany Medical College, Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Silverman', 'Affiliation': 'Department of Anesthesiology, Albany Medical Center, Albany, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Carl', 'Affiliation': 'Department of Orthopedic Surgery, Albany Medical Center, Albany, USA. alcsar308@gmail.com.'}]",Spine deformity,['10.1007/s43390-020-00073-w']
2979,31707860,Slowing Progression of Cardiovascular Calcification With SNF472 in Patients on Hemodialysis: Results of a Randomized Phase 2b Study.,"BACKGROUND


The high cardiovascular morbidity and mortality in patients with end-stage kidney disease could be partially caused by extensive cardiovascular calcification. SNF472, intravenous myo-inositol hexaphosphate, selectively inhibits the formation and growth of hydroxyapatite.
METHODS


This double-blind, placebo-controlled phase 2b trial compared progression of coronary artery calcium volume score and other measurements of cardiovascular calcification by computed tomography scan during 52 weeks of treatment with SNF472 or placebo, in addition to standard therapy, in adult patients with end-stage kidney disease receiving hemodialysis. Patients were randomized 1:1:1 to SNF472 300 mg (n=92), SNF472 600 mg (n=91), or placebo (n=91) by infusion in the hemodialysis lines thrice weekly during hemodialysis sessions. The primary end point was change in log coronary artery calcium volume score from baseline to week 52. The primary efficacy analysis combined the SNF472 treatment groups and included all patients who received at least 1 dose of SNF472 or placebo and had an evaluable computed tomography scan after randomization.
RESULTS


The mean change in coronary artery calcium volume score was 11% (95% CI, 7-15) for the combined SNF472 dose group and 20% (95% CI, 14-26) for the placebo group ( P =0.016). SNF472 compared with placebo attenuated progression of calcium volume score in the aortic valve (14% [95% CI, 5-24] versus 98% [95% CI, 77-123];  P <0.001) but not in the thoracic aorta (23% [95% CI, 16-30] versus 28% [95% CI, 19-38];  P =0.40). Death occurred in 7 patients (4%) who received SNF472 and 5 patients (6%) who received placebo. At least 1 treatment-emergent adverse event occurred in 86%, 92%, and 87% of patients treated with SNF472 300 mg, SNF472 600 mg, and placebo, respectively. Most adverse events were mild. Adverse events resulted in discontinuation of SNF472 300 mg, SNF472 600 mg, and placebo for 14%, 29%, and 20% of patients, respectively.
CONCLUSIONS


Compared with placebo, SNF472 significantly attenuated the progression of coronary artery calcium and aortic valve calcification in patients with end-stage kidney disease receiving hemodialysis in addition to standard care. Future studies are needed to determine the effects of SNF472 on cardiovascular events. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02966028.",2020,"SNF472 compared to placebo attenuated progression of calcium volume score in the aortic valve (14% [95% CI, 5%-24%] vs 98% [95% CI, 77%-123%],  P <0.001), but not in the thoracic aorta (23% [95% CI, 16%-30%] vs 28% [95% CI, 19%-38%], P=0.40).","['patients with end-stage kidney disease (ESKD', 'patients with ESKD receiving hemodialysis in addition to standard care', 'Patients on Hemodialysis', 'adult patients with ESKD receiving hemodialysis']","['SNF472', 'SNF472 or placebo', 'SNF472 600 mg (n=91), or placebo', 'placebo, SNF472', 'placebo']","['progression of CAC and aortic valve calcification', 'mean change in CAC volume score', 'cardiovascular morbidity and mortality', 'progression of calcium volume score', 'log CAC volume score', 'Adverse events', 'thoracic aorta', 'adverse event', 'Death', 'progression of coronary artery calcium (CAC) volume score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0428791', 'cui_str': 'Aortic Stenosis, Calcific'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1562777', 'cui_str': 'Calcium volume'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1522460', 'cui_str': 'Thoracic aorta structure (body structure)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}]",,0.525467,"SNF472 compared to placebo attenuated progression of calcium volume score in the aortic valve (14% [95% CI, 5%-24%] vs 98% [95% CI, 77%-123%],  P <0.001), but not in the thoracic aorta (23% [95% CI, 16%-30%] vs 28% [95% CI, 19%-38%], P=0.40).","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Raggi', 'Affiliation': 'Department of Medicine, Mazankowski Alberta Heart Institute and University of Alberta, Edmonton, Canada (P.R.).'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bellasi', 'Affiliation': 'Research, Innovation and Brand Reputation Unit, ASST Papa Giovanni XXIII, Bergamo, Italy (A.B.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bushinsky', 'Affiliation': 'Department of Medicine, University of Rochester Medical Center, NY (D.B.).'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Bover', 'Affiliation': 'Department of Nephrology, Fundació Puigvert and Universitat Autònoma, IIB Sant Pau, REDinREN, Barcelona, Spain (J.B.).'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Rodriguez', 'Affiliation': 'Nephrology Unit, Hospital Universitario Reina Sofia, IMIBIC, REDinREN, Córdoba, Spain (M.R.).'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Ketteler', 'Affiliation': 'Department of General Internal Medicine and Nephrology, Robert-Bosch-Krankenhaus, Stuttgart, Germany (M.K.).'}, {'ForeName': 'Smeeta', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'Department of Renal Medicine, Salford Royal NHS Foundation Trust, UK (S.S.).'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Salcedo', 'Affiliation': 'Research and Development, Sanifit Therapeutics, Palma, Spain (C.S., J.P.).'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Gillotti', 'Affiliation': 'Research and Development, Sanifit Therapeutics, San Diego, CA (K.G., C.P. R.G., A.G.).'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Padgett', 'Affiliation': 'Research and Development, Sanifit Therapeutics, San Diego, CA (K.G., C.P. R.G., A.G.).'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Garg', 'Affiliation': 'Research and Development, Sanifit Therapeutics, San Diego, CA (K.G., C.P. R.G., A.G.).'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Gold', 'Affiliation': 'Research and Development, Sanifit Therapeutics, San Diego, CA (K.G., C.P. R.G., A.G.).'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Perelló', 'Affiliation': 'Research and Development, Sanifit Therapeutics, Palma, Spain (C.S., J.P.).'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, CA (A.G., G.M.C.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.044195']
2980,32109215,A Comparison of Different Valgancyclovir Formulations in the Universal 6-Month Prophylaxis Against CMV Infection in Renal Transplant Recipients: A Randomized Single-Centre Study.,"INTRODUCTION


Cytomegalovirus (CMV) is the most common opportunistic infective pathogen in kidney transplant recipients. Valganciclovir (VAL) is commonly used for prophylaxis, especially in high-risk recipients. Generic VAL formulations have become available, but the data about their safety and efficacy are lacking.
METHODS


Consecutive de novo kidney transplant patients were randomized to generic VAL Valganciklovir Teva® (VT group)(24 patients) or Alvanocyte® (A group), Alvogen (19 patients) or to Valcyte® (V group), Roche (23 patients) in a 18-month open-label study. Universal prophylaxis was used for 6 months after the transplantation. CMV DNA levels were measured at 1,3,6,9,12 and 18 months after the transplantation. All positive measurements of CMV DNA were recorded.
RESULTS


Groups did not differ regarding the clinical characteristics or the risk for developing CMV infection in the post-transplant period. CMV replications were most common at 9 months after the transplantation with rates of 9% for the V, 13% for the VT and 26% for the A group (p=0.26). At 12 months, positive CMV DNA was recorded in 22%, 8% and 11 % of patients taking V, VT and A, respectively (p=0.37). Rates of biopsy-proven acute rejection, adverse events, and serious adverse events were similar for all formulations. Lymphocele occurred most commonly in the V group (35%) compared to 17% in VT and 17% in the A group (p=0.23). One patient from each of the A and VT groups developed CMV disease. Additionally, they were the only two patients with CMV DNA copies above 656 IU/ml. Glomerular filtration rates were similar in all groups at all time points, while proteinuria was significantly higher at 12 months in patients who received V 0.32 g/day (0.18 - 0.42), compared to patients on VT 0.2 (0.1 - 0.2), or A 0.2 (0.2 - 0.3), p=0.04.
CONCLUSION


Valgancyclovir efficacy and safety in this limited data set is similar with early administration of V, VT and A after kidney transplantation. Additional studies aimed at elucidating the effectiveness of this treatment regimen in patients who are at high risk for developing CMV infection are necessary to draw further conclusions.",2019,Lymphocele occurred most commonly in the V group (35%) compared to 17% in VT and 17% in the A group (p=0.23).,"['Consecutive de novo kidney transplant patients', 'Renal Transplant Recipients', 'kidney transplant recipients', 'patients who are at high risk for developing CMV infection']","['Valganciclovir (VAL', 'Valgancyclovir Formulations', 'generic VAL Valganciklovir Teva® (VT group)(24 patients) or Alvanocyte® (A group), Alvogen (19 patients) or to Valcyte®']","['positive CMV DNA', 'Lymphocele', 'CMV DNA levels', 'Glomerular filtration rates', 'Valgancyclovir efficacy and safety', 'Rates of biopsy-proven acute rejection, adverse events, and serious adverse events', 'CMV disease']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}]","[{'cui': 'C0909381', 'cui_str': 'valganciclovir'}, {'cui': 'C1529218', 'cui_str': 'Vals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0969586', 'cui_str': 'Valcyte'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0024248', 'cui_str': 'Lymphatic Cyst'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.049257,Lymphocele occurred most commonly in the V group (35%) compared to 17% in VT and 17% in the A group (p=0.23).,"[{'ForeName': 'Nikolina', 'Initials': 'N', 'LastName': 'Basic-Jukic', 'Affiliation': 'Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, Croatia.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Furic-Cunko', 'Affiliation': 'Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, Croatia.'}, {'ForeName': 'Tvrtko', 'Initials': 'T', 'LastName': 'Hudolin', 'Affiliation': 'Faculty of Medicine, University of Zagreb, Croatia.'}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Zimak', 'Affiliation': 'Department of Urology, University Hospital Centre Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Kirincich', 'Affiliation': 'Faculty of Medicine, University of Zagreb, Croatia.'}, {'ForeName': 'Zeljko', 'Initials': 'Z', 'LastName': 'Kastelan', 'Affiliation': 'Faculty of Medicine, University of Zagreb, Croatia.'}]",Prilozi (Makedonska akademija na naukite i umetnostite. Oddelenie za medicinski nauki),['10.2478/prilozi-2020-0004']
2981,32125668,Effects of Autograft Types on Muscle Strength and Functional Capacity in Patients Having Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial.,"BACKGROUND


The effects of different autograft types for anterior cruciate ligament reconstruction (ACL-R) on muscle function are sparsely investigated in randomized controlled trials. Our aim was to investigate the effects of quadriceps tendon autograft (QTB) vs. semitendinosus-gracilis autograft (StG) on thigh muscle strength and functional capacity, and a patient-reported outcome 1 year after ACL-R, and to compare the results to healthy controls.
METHODS


ACL-R patients (n = 100) and matched controls (CON, n = 50) were recruited, with patients being randomly assigned to QTB (n = 50) or StG (n = 50) ACL-R. One year after ACL-R, bilateral knee extensor (KE) and flexor (KF) muscle strength (isometric, dynamic, explosive, limb symmetry index [LSI], hamstring:quadriceps ratio [HQ ratio]) were assessed by isokinetic dynamometry, along with functional capacity (single leg hop distance [SHD]) and a patient-reported outcome (International Knee Documentation Committee [IKDC] score).
RESULTS


KE muscle strength of the operated leg was lower (9-11%) in QTB vs. StG as was KE LSI, while KF muscle strength was lower (12-17%) in StG vs. QTB as was KF LSI. HQ ratios were lower in StG vs. QTB. Compared with the controls, KE and KF muscle strength were lower in StG (10-22%), while KE muscle strength only was lower in QTB (16-25%). Muscle strength in the StG, QTB, and CON groups was identical in the non-operated leg. While SHD and IKDC did not differ between StG and QTB, SHD in both StG and QTB was lower than CON. The IKDC scores improved significantly 1 year following ACL-R for both graft types.
CONCLUSION


One year after ACL-R, muscle strength is affected by autograft type, with StG leading to impairments of KE and KF muscle strength, while QTB results in more pronounced impairments of KE only. Functional capacity and patient-reported outcome were unaffected by autograft type, with the former showing impairment compared to healthy controls.
CLINICAL TRIALS REGISTRATION NUMBER


NCT02173483.",2020,"RESULTS


KE muscle strength of the operated leg was lower (9-11%) in QTB vs. StG as was KE LSI, while KF muscle strength was lower (12-17%) in StG vs. QTB as was KF LSI.","['Patients', 'Having Anterior Cruciate Ligament Reconstruction', 'ACL-R patients (n\u2009=\u2009100) and matched controls (CON, n\u2009=\u200950']","['quadriceps tendon autograft (QTB) vs. semitendinosus-gracilis autograft (StG', 'Autograft Types', 'QTB', 'StG (n\u2009=\u200950) ACL-R. One year after ACL-R, bilateral knee extensor (KE) and flexor (KF) muscle strength (isometric, dynamic, explosive, limb symmetry index [LSI], hamstring:quadriceps ratio [HQ ratio]) were assessed by isokinetic dynamometry, along with functional capacity (single leg hop distance [SHD', 'anterior cruciate ligament reconstruction (ACL-R']","['patient-reported outcome (International Knee Documentation Committee [IKDC] score', 'KE muscle strength of the operated leg', 'IKDC scores', 'KE and KF muscle strength', 'thigh muscle strength and functional capacity', 'Muscle Strength and Functional Capacity', 'KE muscle strength', 'Muscle strength', 'KF muscle strength', 'HQ ratios']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1721090', 'cui_str': 'Explosives'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0471684,"RESULTS


KE muscle strength of the operated leg was lower (9-11%) in QTB vs. StG as was KE LSI, while KF muscle strength was lower (12-17%) in StG vs. QTB as was KF LSI.","[{'ForeName': 'Kasper Staghøj', 'Initials': 'KS', 'LastName': 'Sinding', 'Affiliation': 'Department of Sports Traumatology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Torsten Grønbech', 'Initials': 'TG', 'LastName': 'Nielsen', 'Affiliation': 'Department of Sports Traumatology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Lars Grøndahl', 'Initials': 'LG', 'LastName': 'Hvid', 'Affiliation': 'Exercise Biology, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Department of Orthopedic Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dalgas', 'Affiliation': 'Exercise Biology, Department of Public Health, Aarhus University, Aarhus, Denmark. dalgas@ph.au.dk.'}]","Sports medicine (Auckland, N.Z.)",['10.1007/s40279-020-01276-x']
2982,31542339,Intravitreal Aflibercept for Retinal Nonperfusion in Proliferative Diabetic Retinopathy: Outcomes from the Randomized RECOVERY Trial.,"PURPOSE


Evaluate the impact of intravitreal aflibercept (Eylea; Regeneron, Tarrytown, NY) on retinal nonperfusion (RNP) in eyes with proliferative diabetic retinopathy (PDR).
DESIGN


Prospective, randomized clinical trial.
PARTICIPANTS


Eyes with treatment-naïve PDR and extensive RNP without diabetic macular edema.
METHODS


Patients were randomized 1:1 to intravitreal 2 mg aflibercept every 4 weeks (monthly) or every 12 weeks (quarterly).
MAIN OUTCOME MEASURES


The primary outcome measure was change in total RNP area (in square millimeters) from baseline to year 1. Secondary outcomes included ischemic index (ISI), diabetic retinopathy severity scale (DRSS) scores, visual acuity, central retinal thickness, and adverse events. The mean and 95% confidence interval were calculated for each outcome.
RESULTS


Through 1 year, the monthly (n = 20) and quarterly (n = 20) cohorts received 11.0 and 3.95 mean aflibercept injections, and DRSS scores improved 2 steps or more in 74% and 67% of patients, respectively. Among all patients through 1 year, mean total area of RNP increased from 235 mm 2  to 266 mm 2  (P = 0.18) and ISI increased from 25.8% to 31.9% (P = 0.004). Retinal nonperfusion outcomes favored monthly dosing. Mean total RNP increased from 207 mm 2  at baseline to 268 mm 2  (P = 0.01) at 1 year in the quarterly cohort and remained stable at 264 mm 2  at baseline and 1 year (P = 0.70) in the monthly cohort (P = 0.05, monthly vs. quarterly cohorts). Although many eyes demonstrated increased areas of RNP longitudinally (n = 24 [66.7%]), this was more common with quarterly dosing (n = 14 [77.8%]), and a proportion of eyes (n = 12 [33.3%]) demonstrated localized areas of apparent reperfusion of nonperfused retina, more commonly in the monthly cohort (n = 8 [44.4%]).
CONCLUSIONS


Widespread evidence of retinal reperfusion with aflibercept dosing of PDR eyes with extensive RNP was not identified, and therefore the primary outcome of the current study was not met. Nevertheless, zones of apparent reperfusion were detected in some patients, and a dose response was identified with a reduction of RNP progression with monthly compared to quarterly dosing.",2019,"Mean total RNP increased from 207 mm 2  at baseline to 268 mm 2  (P = 0.01) at 1 year in the quarterly cohort and remained stable at 264 mm 2  at baseline and 1 year (P = 0.70) in the monthly cohort (P = 0.05, monthly vs. quarterly cohorts).","['eyes with proliferative diabetic retinopathy (PDR', 'Proliferative Diabetic Retinopathy', 'Patients', 'Eyes with treatment-naïve PDR and extensive RNP without diabetic macular edema']","['Intravitreal Aflibercept', 'intravitreal 2 mg aflibercept', 'intravitreal aflibercept (Eylea; Regeneron, Tarrytown, NY) on retinal nonperfusion (RNP', 'aflibercept']","['ischemic index (ISI), diabetic retinopathy severity scale (DRSS) scores, visual acuity, central retinal thickness, and adverse events', 'DRSS scores', 'Mean total RNP', 'mean total area of RNP', 'ISI', 'change in total RNP area', 'RNP progression']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C3248025', 'cui_str': 'Eylea'}, {'cui': 'C4049512', 'cui_str': 'Retinal nonperfusion'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",,0.121151,"Mean total RNP increased from 207 mm 2  at baseline to 268 mm 2  (P = 0.01) at 1 year in the quarterly cohort and remained stable at 264 mm 2  at baseline and 1 year (P = 0.70) in the monthly cohort (P = 0.05, monthly vs. quarterly cohorts).","[{'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas; Blanton Eye Institute, Houston Methodist Hospital & Weill Cornell Medical College, Houston, Texas. Electronic address: ccwmd@houstonretina.com.'}, {'ForeName': 'Muneeswar G', 'Initials': 'MG', 'LastName': 'Nittala', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Swetha Bindu', 'Initials': 'SB', 'LastName': 'Velaga', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Shaun I R', 'Initials': 'SIR', 'LastName': 'Lampen', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Rusakevich', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Justis P', 'Initials': 'JP', 'LastName': 'Ehlers', 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio; Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Babiuch', 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio; Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Brown', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas; Blanton Eye Institute, Houston Methodist Hospital & Weill Cornell Medical College, Houston, Texas.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Ip', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'SriniVas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Retina,['10.1016/j.oret.2019.07.011']
2983,32065499,Development and randomised controlled trial of a Continence Product Patient Decision Aid for men postradical prostatectomy.,"AIMS AND OBJECTIVES


To develop and evaluate an evidence-based Continence Product Patient Decision Aid (CP-PDA) to reduce decisional conflict and support continence product choice for men postradical prostatectomy.
BACKGROUND


In 2018, 1.3 million men globally were diagnosed with prostate cancer. A common treatment is radical prostatectomy, usually leading to sudden onset of urinary incontinence. For people experiencing incontinence, products to contain leakage are fundamental to health-related quality of life, but many product users and healthcare professionals are unaware of available options. No evidence-based guidance on choosing products exists despite known physical and psychological burdens of poorly managed leakage (e.g. isolation, anxiety, depression, skin damage).
DESIGN AND METHODS


4 phases, underpinned by international decision aid guidance. Evidence/expert opinion: Literature review; consultation with specialist continence clinicians (n = 7) to establish evidence base. Prototype: CP-PDA developed with continence specialist (n = 7) feedback. Alpha testing (stakeholders): CP-PDA materials were provided to expert patients (n = 10) and clinicians (n = 11) to assess content/presentation. Beta testing (field) following CONSORT guidelines, registered NIHR CPMS 31077: Men (n = 50) postradical prostatectomy randomised to evaluate usability and decision-making using the Decisional Conflict Scale compared with usual care.
RESULTS


An algorithm differentiating patients by mobility, dependency, cognitive impairment and type/level of leakage, leading to 12 user groups, was developed. For each group, an option table and associated product information sheets guide product choice. Total Decisional Conflict Score for men using the CP-PDA was significantly better than for men without. CP-PDA users reported greater confidence in product knowledge and choice.
CONCLUSION


This is the first evidence-based CP-PDA, developed using an internationally recognised method. Compared to usual care, it significantly reduced decisional conflict for men choosing continence products postprostatectomy.
RELEVANCE TO CLINICAL PRACTICE


The CP-PDA provides nurses with the first comprehensive, evidence-based intervention to help postprostatectomy men in complex continence product choices. An online version is available: www.continenceproductadvisor.org.",2020,Total Decisional Conflict Score for men using the CP-PDA was significantly better than for men without.,"['In 2018, 1.3 million men globally were diagnosed with prostate cancer', '4 phases, underpinned by international decision-aid guidance', 'men post-radical prostatectomy']","['Alpha testing (stakeholders', 'evidence-based Continence Product Patient Decision Aid (CP- PDA', 'Continence Product Patient Decision Aid', 'CP-PDA', 'Prototype: CP-PDA']","['decisional conflict', 'Total Decisional Conflict Score']","[{'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",31077.0,0.0729149,Total Decisional Conflict Score for men using the CP-PDA was significantly better than for men without.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Murphy', 'Affiliation': 'School of Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'de Laine', 'Affiliation': 'School of Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Macaulay', 'Affiliation': 'School of Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Fader', 'Affiliation': 'School of Health Sciences, University of Southampton, Southampton, UK.'}]",Journal of clinical nursing,['10.1111/jocn.15223']
2984,31206083,"Effect of dose reduction of supplemental zinc for childhood diarrhoea: study protocol for a double-masked, randomised controlled trial in India and Tanzania.","Background


Diarrhoea-associated mortality and morbidity are highest in infants and young children in low-income and middle-income countries (LMICs). Zinc supplementation during acute diarrhoea has been shown to reduce the duration of illness and the risk of persistent diarrhoea. However, vomiting with zinc supplementation is a common side effect that may interfere with compliance and programmatic scale-up, and may be related to the dose prescribed.
Methods/design


The Zinc Therapeutic Dose Trial (ZTDT) is a two-centre (Tanzania and India), three-arm randomised, double-blind controlled non-inferiority trial. Children 6-59 months of age with acute diarrhoea are eligible to participate. Enrolled children (1500 per arm; 4500 total) will be randomly allocated to receive 5, 10 or 20 mg of zinc sulfate daily for 14 days and will be followed up for 60 days after enrolment. All children will receive WHO/Unicef Integrated Management of Childhood Illness standard of care (oral or intravenous rehydration and zinc as indicated and feeding advice). The primary efficacy outcomes of the trial are the percentage of subjects with diarrhoea duration >5 days, the mean total number of loose or watery stools after enrolment and the proportion of children vomiting within 30 min of zinc administration.
Discussion


The ZTDT trial will determine the optimal dose of therapeutic zinc supplements for treatment of acute diarrhoea in children aged 6-59 months in two LMICs. The results of the trial are likely to be generalisable to childhood acute diarrhoea in similar resource-limited settings and may influence global policy about zinc supplementation dosage during acute diarrhoea.
Trial registration number


NCT03078842.
Trial status


Enrolment began in January 2017 and follow-up is estimated to be completed by April 2019. As of 1 February 2019, 742 children are still contributing data to the ZTDT study.",2019,"Enrolled children (1500 per arm; 4500 total) will be randomly allocated to receive 5, 10 or 20 mg of zinc sulfate daily for 14 days and will be followed up for 60 days after enrolment.","['Enrolled children (1500 per arm; 4500 total', 'children aged 6-59 months in two LMICs', '742 children are still contributing data to the ZTDT study', 'childhood diarrhoea', 'Children 6-59 months of age with acute diarrhoea are eligible to participate', 'infants and young children in low-income and middle-income countries (LMICs']","['India and Tanzania', 'therapeutic zinc supplements', 'Zinc supplementation', 'zinc sulfate', 'care (oral or intravenous rehydration and zinc as indicated and feeding advice', 'supplemental zinc']","['percentage of subjects with diarrhoea duration >5 days, the mean total number of loose or watery stools after enrolment and the proportion of children vomiting', 'acute diarrhoea']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4517780', 'cui_str': 'Four thousand five hundred'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea (disorder)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3541396', 'cui_str': 'Zinc'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0034997', 'cui_str': 'Rehydration'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205407', 'cui_str': 'Loose (qualifier value)'}, {'cui': 'C2129214', 'cui_str': 'Loose stool (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea (disorder)'}]",,0.584206,"Enrolled children (1500 per arm; 4500 total) will be randomly allocated to receive 5, 10 or 20 mg of zinc sulfate daily for 14 days and will be followed up for 60 days after enrolment.","[{'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Somji', 'Affiliation': 'Department of Pediatrics, Muhimbili University of Health and Allied Sciences, Dar es Salaam, United Republic of Tanzania.'}, {'ForeName': 'Pratibha', 'Initials': 'P', 'LastName': 'Dhingra', 'Affiliation': 'Centre for Public Health Kinetics (CPHK), New Delhi, Delhi, India.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Dhingra', 'Affiliation': 'Centre for Public Health Kinetics (CPHK), New Delhi, Delhi, India.'}, {'ForeName': 'Arup', 'Initials': 'A', 'LastName': 'Dutta', 'Affiliation': 'Centre for Public Health Kinetics (CPHK), New Delhi, Delhi, India.'}, {'ForeName': 'Prabhabati', 'Initials': 'P', 'LastName': 'Devi', 'Affiliation': 'Centre for Public Health Kinetics (CPHK), New Delhi, Delhi, India.'}, {'ForeName': 'Jitendra', 'Initials': 'J', 'LastName': 'Kumar', 'Affiliation': 'Centre for Public Health Kinetics (CPHK), New Delhi, Delhi, India.'}, {'ForeName': 'Saikat', 'Initials': 'S', 'LastName': 'Deb', 'Affiliation': 'Centre for Public Health Kinetics (CPHK), New Delhi, Delhi, India.'}, {'ForeName': 'Om Prakash', 'Initials': 'OP', 'LastName': 'Semwal', 'Affiliation': 'Centre for Public Health Kinetics (CPHK), New Delhi, Delhi, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Sazawal', 'Affiliation': 'Centre for Public Health Kinetics (CPHK), New Delhi, Delhi, India.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Manji', 'Affiliation': 'Department of Pediatrics, Muhimbili University of Health and Allied Sciences, Dar es Salaam, United Republic of Tanzania.'}, {'ForeName': 'Rodrick', 'Initials': 'R', 'LastName': 'Kisenge', 'Affiliation': 'Department of Pediatrics, Muhimbili University of Health and Allied Sciences, Dar es Salaam, United Republic of Tanzania.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bakari', 'Affiliation': 'Department of Pediatrics, Muhimbili University of Health and Allied Sciences, Dar es Salaam, United Republic of Tanzania.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Aboud', 'Affiliation': 'Department of Pediatrics, Muhimbili University of Health and Allied Sciences, Dar es Salaam, United Republic of Tanzania.'}, {'ForeName': 'Enju', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': ""Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sudfeld', 'Affiliation': 'Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Duggan', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'Tampereen yliopisto, Tampere, Finland.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Bahl', 'Affiliation': 'Organisation mondiale de la Sante, Geneva, Switzerland.'}, {'ForeName': 'Jonathon L', 'Initials': 'JL', 'LastName': 'Simon', 'Affiliation': 'Organisation mondiale de la Sante, Geneva, Switzerland.'}]",BMJ paediatrics open,['10.1136/bmjpo-2019-000460']
2985,32071329,A cluster-randomized trial of the effectiveness of a triple-faceted intervention promoting adherence to primary care physician visits by diabetes patients.,"We aimed to assess whether a triple-faceted intervention program administered in the primary care setting could decrease the risk of insufficient adherence to primary care physician (PCP) appointments among this patient population. We conducted a cluster-randomized controlled study to assess the effects of a 1-year intervention. The primary outcome was insufficient adherence to regular PCP attendance for diabetes treatment, defined as failure to visit a PCP within 2 months of an original appointment date. The intervention consisted of mailing patient reminders of their PCP appointments, providing patients with health education aimed at lifestyle modification and benchmarking PCP procedures. Eleven municipal level district medical associations employing 192 PCPs were divided into two subregions for assignment to intervention and control clusters, with 971 and 1,265 patients assigned to the intervention and control groups, respectively. Primary outcome data were available for 2,200 patients. The intervention reduced insufficient adherence to regular PCP appointments by 63% (hazard ratio, 0.37; 95% confidence interval [CI], 0.23-0.58). In conclusion, a triple-faceted intervention program consisting of health education, appointment reminders, and physician benchmarking may decrease the risk of incomplete adherence to regular PCP appointments by diabetes patients.",2020,"The intervention reduced insufficient adherence to regular PCP appointments by 63% (hazard ratio, 0.37; 95% confidence interval [CI], 0.23-0.58).","['primary care physician (PCP) appointments among this patient population', 'primary care physician visits by diabetes patients', 'Eleven municipal level district medical associations employing 192 PCPs']","['mailing patient reminders of their PCP appointments, providing patients with health education aimed at lifestyle modification and benchmarking PCP procedures', 'triple-faceted intervention', 'triple-faceted intervention program']","['insufficient adherence to regular PCP attendance for diabetes treatment, defined as failure to visit a PCP within 2 months of an original appointment date']","[{'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}]","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0018701'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0332225', 'cui_str': 'Faceted (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0585085', 'cui_str': 'Appointment date (finding)'}]",192.0,0.0817496,"The intervention reduced insufficient adherence to regular PCP appointments by 63% (hazard ratio, 0.37; 95% confidence interval [CI], 0.23-0.58).","[{'ForeName': 'Mitsuhiko', 'Initials': 'M', 'LastName': 'Noda', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Ichikawa Hospital, International University of Health and Welfare, 6-1-14 Kounodai, Ichikawa, Chiba, Japan. noda-m@iuhw.ac.jp.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Hayashino', 'Affiliation': 'Department of Endocrinology, Tenri Hospital, 200 Mishimacho, Tenri, Nara, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'First Department of Internal Medicine, Faculty of Medicine, Toyama University, 2630 Sugitani, Toyama, Toyama, Japan.'}, {'ForeName': 'Hikari', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'First Department of Internal Medicine, Faculty of Medicine, Toyama University, 2630 Sugitani, Toyama, Toyama, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Goto', 'Affiliation': 'Diabetes Research Center, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Toranomon Hospital Health Management Center and Diagnostic Imaging Center, 2-2-2 Toranomon, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Izumi', 'Affiliation': 'Center for Clinical Sciences, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'First Department of Internal Medicine, Faculty of Medicine, Toyama University, 2630 Sugitani, Toyama, Toyama, Japan.'}]",Scientific reports,['10.1038/s41598-020-59588-x']
2986,32122703,Effect of photobiomodulation on recovery from neurosensory disturbances after sagittal split ramus osteotomy: a triple-blind randomised controlled trial.,"We have investigated the effect of photobiomodulation on the recovery of neurosensory function of the lip and chin after bilateral sagittal split osteotomy (BSSO). Laser irradiation was applied with a GaAs diode laser (continuous wave 980nm wavelength, power 100mW, and energy density 12J/cm 2 ). It was maintained within a 0.5cm 2  area in a total of 12 points for 60seconds at each visit on each point. Unilateral extraoral contact photobiomodulation treatment was applied the day before operation and then on days 1, 3, 7, 14, 21, and 28 postoperatively. One side of the mandible was the intervention side and the other the control side. On the control side, the laser probe was turned off and placed on the chosen area. Neurosensory evaluations were made before and immediately after operation, and 30 days and 60 days postoperatively. Twenty-five patients were screened, and 18 who met the inclusion criteria were included in the study; 14 were women and the mean (SD) age was 23 (5) years. Analysis of the visual analogue scales for general sensibility, pain discrimination, directional discrimination, and 2-point discrimination showed a significant difference between the intervention and control sides after 30 days (p=0.0011, 0.0034, 0.0023, and 0.0160, respectively). The difference was also significant after 60 days (p=0.0001, 0.0002, 0.0003, and 0.0010, respectively). The thermal discrimination rate was significantly higher in the laser group than the control group 30 days after surgery (p=0.002), but after 60 days the difference was not significant (p=1.000). We found no side effects from the laser radiation during the two-month follow up. The results suggest that photobiomodulation accelerated the patients' improvement from neurosensory disturbance after BSSO.",2020,"The thermal discrimination rate was significantly higher in the laser group than the control group 30 days after surgery (p=0.002), but after 60 days the difference was not significant (p=1.000).","['lip and chin after bilateral sagittal split osteotomy (BSSO', 'Twenty-five patients were screened, and 18 who met the inclusion criteria were included in the study; 14 were women and the mean (SD) age was 23 (5) years', 'neurosensory disturbances after sagittal split ramus osteotomy']","['photobiomodulation', 'Laser irradiation was applied with a GaAs diode laser']","['thermal discrimination rate', 'visual analogue scales for general sensibility, pain discrimination, directional discrimination, and 2-point discrimination', 'Neurosensory evaluations', 'neurosensory disturbance']","[{'cui': 'C0333972', 'cui_str': 'Lipping (morphologic abnormality)'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0616096', 'cui_str': 'BSSO'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0618884', 'cui_str': 'IS 23'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0061005', 'cui_str': 'gallium arsenide'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}]","[{'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",14.0,0.0671275,"The thermal discrimination rate was significantly higher in the laser group than the control group 30 days after surgery (p=0.002), but after 60 days the difference was not significant (p=1.000).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sharifi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Cranio Maxillofacial Research Center, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fekrazad', 'Affiliation': 'Department of Periodontology, Dental Faculty - Radiation Sciences Research Center, Laser Research Center in Medical Sciences, Aja University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Taheri', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Cranio Maxillofacial Research Center, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: hamedta90@gmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kasaeian', 'Affiliation': 'Hematology-Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sciences, Tehran, Iran; Pars Advanced and Minimally Invasive Medical Manners Research Center, Pars Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Babaei', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran; Otolaryngology Research Center, Department of Otolaryngology, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2020.02.005']
2987,31387766,A randomized controlled trial of public messaging to promote safe firearm storage among U.S. military veterans.,"BACKGROUND


The objectives of this study were to determine whether short-term exposure to firearm safety messaging significantly improved (1) firearm storage practices, and (2) attitudes of safe firearm storage behaviors among U.S. veterans, a group at elevated risk for firearm suicide.
DESIGN


A three-arm, parallel-group RCT was conducted online in the U.S. nationwide from December 2015 to January 2016.
SETTING


A national random sample of U.S. veterans (N = 358) was recruited from the GfK KnowledgePanel, a probability-based internet panel representative of U.S. adults. All study activities were administered online over a three-week study period.
INTERVENTION


Participants were randomized and exposed three times (once per week) to either (a) firearm safety message only (n = 115); (b) firearm safety and mental health promotion messages (n = 133); or (c) active control group exposed to mental health promotion message only (n = 110). Each message was less than two minutes long.
MEASURES


Assessments were completed at baseline (pre-randomization) and at end-of-trial. Changes in awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices were measured using self-reported surveys. Linear mixed effect models with weighted generalized estimating equations were used to test for exposure effects. Analyses were conducted February 2018.
RESULTS


Analyses restricted to those with baseline firearm access (n = 195) identified no significant changes for intentions or safe storage practices across exposure groups. At baseline, participants' attitudes and beliefs were generally supportive of safe firearm storage. The Firearm Safety message yielded small increases in agreement with the concept that secure storage is ""important during emotional or stressful times"" (0.36; 95% CI = 0.08, 0.64). Other significant changes in awareness and beliefs were found, but across all study conditions.
CONCLUSION


Results reinforce the critical need for considerable research and testing prior to the widespread implementation of public messages to increase the likelihood for desired exposure effects.",2019,"Changes in awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices were measured using self-reported surveys.","['U.S. military veterans', 'U.S. veterans, a group at elevated risk for firearm suicide', 'A national random sample of U.S. veterans (N\u202f=\u202f358) was recruited from the GfK KnowledgePanel, a probability-based internet panel representative of U.S. adults']","['public messaging', 'firearm safety message only (n\u202f=\u202f115); (b) firearm safety and mental health promotion messages (n\u202f=\u202f133); or (c) active control group exposed to mental health promotion message']","['awareness and beliefs', 'intentions or safe storage practices', 'awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0016139', 'cui_str': 'Firearms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0016139', 'cui_str': 'Firearms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.0646168,"Changes in awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices were measured using self-reported surveys.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Karras', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Department of Psychiatry, University of Rochester, Rochester, NY, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA. Electronic address: Elizabeth.Karras@va.gov.'}, {'ForeName': 'Cara M', 'Initials': 'CM', 'LastName': 'Stokes', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Warfield', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Shannon K', 'Initials': 'SK', 'LastName': 'Barth', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Bossarte', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA; Department of Behavioral Medicine and Psychiatry, School of Medicine, West Virginia University, Morgantown, WV, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.03.001']
2988,31626010,Not All Garden-I and II Femoral Neck Fractures in the Elderly Should Be Fixed: Effect of Posterior Tilt on Rates of Subsequent Arthroplasty.,"BACKGROUND


Internal fixation is currently the standard of care for Garden-I and II femoral neck fractures in elderly patients. However, there may be a degree of posterior tilt (measured on preoperative lateral radiograph) above which failure is likely, and primary arthroplasty would be preferred. The purpose of this analysis was to determine the association between posterior tilt and the risk of subsequent arthroplasty following internal fixation of Garden-I and II femoral neck fractures in elderly patients.
METHODS


This study is a preplanned secondary analysis of data collected in the FAITH (Fixation using Alternative Implants for the Treatment of Hip fractures) trial, an international, multicenter, randomized controlled trial comparing the sliding hip screw with cannulated screws in the treatment of femoral neck fractures in patients ≥50 years old. For each patient who sustained a Garden-I or II femoral neck fracture and had an adequate preoperative lateral radiograph, the amount of posterior tilt was categorized as <20° or ≥20°. Multivariable Cox proportional hazards analysis was used to assess the association between posterior tilt and subsequent arthroplasty during the 2-year follow-up period, controlling for potential confounders.
RESULTS


Of the 555 patients in the study sample, 67 (12.1%) had posterior tilt ≥20° and 488 (87.9%) had posterior tilt <20°. Overall, 73 (13.2%) of 555 patients underwent subsequent arthroplasty in the 24-month follow-up period. In the multivariable analysis, patients with posterior tilt ≥20° had a significantly higher risk of subsequent arthroplasty compared with those with posterior tilt <20° (22.4% [15 of 67] compared with 11.9% [58 of 488]; hazard ratio, 2.22; 95% confidence interval, 1.24 to 4.00; p = 0.008). The other factor associated with subsequent arthroplasty was age ≥80 years (p = 0.03).
CONCLUSIONS


In this analysis of patients with Garden-I and II femoral neck fractures, posterior tilt ≥20° was associated with a significantly increased risk of subsequent arthroplasty. Primary arthroplasty may be considered for Garden-I and II femoral neck fractures with posterior tilt ≥20°, especially among older patients.
LEVEL OF EVIDENCE


Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.",2019,"In the multivariable analysis, patients with posterior tilt ≥20° had a significantly higher risk of subsequent arthroplasty compared with those with posterior tilt <20° (22.4% [15 of 67] compared with 11.9% [58 of 488]; hazard ratio, 2.22; 95% confidence interval, 1.24 to 4.00; p = 0.008).","['555 patients in the study sample, 67 (12.1%) had posterior tilt ≥20° and 488 (87.9%) had posterior tilt <20°', 'femoral neck fractures in patients ≥50 years old', 'Garden-I and II femoral neck fractures in elderly patients', 'elderly patients', 'older patients']","['FAITH (Fixation using Alternative Implants', 'internal fixation of Garden-I and II femoral neck fractures', 'Posterior Tilt', 'sliding hip screw with cannulated screws']","['risk of subsequent arthroplasty', 'Rates of Subsequent Arthroplasty']","[{'cui': 'C4517810', 'cui_str': 'Five hundred and fifty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0015806', 'cui_str': 'Femur Neck Fractures'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4019428', 'cui_str': 'Gardens'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C4019428', 'cui_str': 'Gardens'}, {'cui': 'C0015806', 'cui_str': 'Femur Neck Fractures'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]",555.0,0.0493184,"In the multivariable analysis, patients with posterior tilt ≥20° had a significantly higher risk of subsequent arthroplasty compared with those with posterior tilt <20° (22.4% [15 of 67] compared with 11.9% [58 of 488]; hazard ratio, 2.22; 95% confidence interval, 1.24 to 4.00; p = 0.008).","[{'ForeName': 'Kanu', 'Initials': 'K', 'LastName': 'Okike', 'Affiliation': 'Department of Orthopaedics, Kaiser Moanalua Medical Center, Honolulu, Hawaii.'}, {'ForeName': 'Ugochukwu N', 'Initials': 'UN', 'LastName': 'Udogwu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Marckenley', 'Initials': 'M', 'LastName': 'Isaac', 'Affiliation': 'Florida State University College of Medicine, Tallahassee, Florida.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Marc F', 'Initials': 'MF', 'LastName': 'Swiontkowski', 'Affiliation': 'Department of Orthopaedic Surgery, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Gerard P', 'Initials': 'GP', 'LastName': 'Slobogean', 'Affiliation': 'Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.18.01256']
2989,31628428,Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study.,"RESONATE-2 is a phase 3 study of first-line ibrutinib versus chlorambucil in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Patients aged ≥65 years (n = 269) were randomized 1:1 to once-daily ibrutinib 420 mg continuously or chlorambucil 0.5-0.8 mg/kg for ≤12 cycles. With a median (range) follow-up of 60 months (0.1-66), progression-free survival (PFS) and overall survival (OS) benefits for ibrutinib versus chlorambucil were sustained (PFS estimates at 5 years: 70% vs 12%; HR [95% CI]: 0.146 [0.098-0.218]; OS estimates at 5 years: 83% vs 68%; HR [95% CI]: 0.450 [0.266-0.761]). Ibrutinib benefit was also consistent in patients with high prognostic risk (TP53 mutation, 11q deletion, and/or unmutated IGHV) (PFS: HR [95% CI]: 0.083 [0.047-0.145]; OS: HR [95% CI]: 0.366 [0.181-0.736]). Investigator-assessed overall response rate was 92% with ibrutinib (complete response, 30%; 11% at primary analysis). Common grade ≥3 adverse events (AEs) included neutropenia (13%), pneumonia (12%), hypertension (8%), anemia (7%), and hyponatremia (6%); occurrence of most events as well as discontinuations due to AEs decreased over time. Fifty-eight percent of patients continue to receive ibrutinib. Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.",2020,Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.,"['patients with CLL/SLL', 'chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL', 'Patients aged ≥65 years (n\u2009=\u2009269']","['daily ibrutinib 420\u2009mg continuously or chlorambucil 0.5-0.8\u2009mg/kg for ≤12 cycles', 'first-line ibrutinib treatment', 'chlorambucil']","['hyponatremia', 'Investigator-assessed overall response rate', 'progression-free survival (PFS) and overall survival (OS) benefits', 'anemia', 'pneumonia', 'neutropenia', 'hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0024303', 'cui_str': 'Lymphocytic lymphoma'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4555385', 'cui_str': 'Ibrutinib 420 MG'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",,0.152562,Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.,"[{'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Burger', 'Affiliation': 'Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA. jaburger@mdanderson.org.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Barr', 'Affiliation': 'Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Owen', 'Affiliation': 'Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': 'Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tedeschi', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Osnat', 'Initials': 'O', 'LastName': 'Bairey', 'Affiliation': 'Rabin Medical Center, Petah Tikva, Israel and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': 'The Leeds Teaching Hospitals, St. James Institute of Oncology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Coutre', 'Affiliation': 'Stanford Cancer Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Devereux', 'Affiliation': 'Kings College Hospital, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Department of Hematology and Cancer Prevention, Silesiam Medical University, Katowice, Poland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McCarthy', 'Affiliation': 'Royal Bournemouth General Hospital, Bournemouth, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simpson', 'Affiliation': 'North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'Universitair Ziekenhuis Gent, Gent, Belgium.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Moreno', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Dai', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Indu', 'Initials': 'I', 'LastName': 'Lal', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Dean', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': 'UCSD Moores Cancer Center, San Diego, CA, USA.'}]",Leukemia,['10.1038/s41375-019-0602-x']
2990,31473172,Higher-Order Assessment of OCT in Diabetic Macular Edema from the VISTA Study: Ellipsoid Zone Dynamics and the Retinal Fluid Index.,"PURPOSE


To investigate retinal fluid features and ellipsoid zone (EZ) integrity dynamics on spectral-domain OCT (SD-OCT) in eyes with diabetic macular edema (DME) treated with intravitreal aflibercept injection (IAI) in the VISTA-DME study.
DESIGN


A post hoc subanalysis of a phase III, prospective clinical trial.
PARTICIPANTS


Eyes received either IAI 2 mg every 4 weeks (2q4) or every 8 weeks after 5 initial monthly doses (2q8).
METHODS


All eyes from the VISTA Phase III study in the IAI groups imaged with the Cirrus HD-OCT system (Zeiss, Oberkochen, Germany) were included. The OCT macular cube datasets were evaluated using a novel software platform to generate retinal layer and fluid boundary lines that were manually corrected for assessment of change in EZ parameters and volumetric fluid parameters from baseline. The retinal fluid index (i.e., proportion of the retinal volume consisting of cystic fluid) was also calculated at each time point.
MAIN OUTCOME MEASURES


The feasibility of volumetric assessment of higher-order OCT-based retinal parameters and its correlation with best-corrected visual acuity (BCVA).
RESULTS


Overall, 106 eyes of 106 patients were included. Specifically, 52 eyes of 52 patients were included in the IAI 2q4 arm, and 54 eyes of 54 patients were included in the IAI 2q8 arm. Ellipsoid zone integrity metrics significantly improved from baseline to week 100, including central macular mean EZ to retinal pigment epithelium (RPE) thickness (2q4: 26.6 μm to 31.6 μm, P < 0.001; 2q8: 25.2 μm to 31.4 μm, P < 0.001). At week 100, central macular intraretinal fluid volume was reduced by >65% (P < 0.001) and central macular subretinal fluid volume was reduced by >99% in both arms (P < 0.001). Central macular retinal fluid index (RFI) significantly improved in both arms (2q4: 17.9% to 7.2%, P < 0.001; 2q8: 19.8% to 4.2%, P < 0.001). Central macular mean EZ-RPE thickness (i.e., a surrogate for photoreceptor outer segment length) and central RFI were independently correlated with BCVA at multiple follow-up visits.
CONCLUSIONS


Intravitreal aflibercept injection resulted in significant improvement in EZ integrity and quantitative fluid metrics in both 2q4 and 2q8 arms and correlated with visual function.",2019,"At week 100, central macular intraretinal fluid volume was reduced by >65% (P < 0.001) and central macular subretinal fluid volume was reduced by >99% in both arms (P < 0.001).","['Diabetic Macular Edema from the VISTA Study', '106 eyes of 106 patients were included', 'eyes with diabetic macular edema (DME', '52 eyes of 52 patients were included in the IAI 2q4 arm, and 54 eyes of 54 patients were included in the IAI 2q8 arm']","['intravitreal aflibercept injection (IAI', 'OCT']","['central macular mean EZ to retinal pigment epithelium (RPE) thickness ', 'Central macular mean EZ-RPE thickness', 'visual function', 'Ellipsoid zone integrity metrics', 'central macular subretinal fluid volume', 'central macular intraretinal fluid volume', 'Central macular retinal fluid index (RFI', 'EZ integrity and quantitative fluid metrics', 'retinal fluid index']","[{'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035322', 'cui_str': 'Retinal Pigment Epithelium'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",106.0,0.0701755,"At week 100, central macular intraretinal fluid volume was reduced by >65% (P < 0.001) and central macular subretinal fluid volume was reduced by >99% in both arms (P < 0.001).","[{'ForeName': 'Justis P', 'Initials': 'JP', 'LastName': 'Ehlers', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address: ehlersj@ccf.org.'}, {'ForeName': 'Atsuro', 'Initials': 'A', 'LastName': 'Uchida', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio; Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Figueiredo', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Kaiser', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Heier', 'Affiliation': 'Ophthalmic Consultants of Boston, Boston, Massachusetts.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Brown', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Boyer', 'Affiliation': 'Retinal-Vitreous Associates, Los Angeles, California.'}, {'ForeName': 'Diana V', 'Initials': 'DV', 'LastName': 'Do', 'Affiliation': 'Byers Eye Institute, Stanford University, Palo Alto, California.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gibson', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Saroj', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York.'}, {'ForeName': 'Sunil K', 'Initials': 'SK', 'LastName': 'Srivastava', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}]",Ophthalmology. Retina,['10.1016/j.oret.2019.06.010']
2991,31582304,Secondary and Exploratory Outcomes of the Subthreshold Nanosecond Laser Intervention Randomized Trial in Age-Related Macular Degeneration: A LEAD Study Report.,"PURPOSE


To evaluate the secondary and exploratory outcomes of the Laser Intervention in Early Stages of Age-Related Macular Degeneration (LEAD) study, a 36-month trial of a subthreshold nanosecond laser (SNL) treatment for slowing the progression to late age-related macular degeneration (AMD) in its early stages.
DESIGN


Multicenter, randomized, sham-controlled trial.
PARTICIPANTS


Two-hundred ninety-two patients with bilateral large drusen.
METHODS


Participants were randomly assigned to receive SNL or sham treatment to the study eye at 6-month intervals.
MAIN OUTCOME MEASURES


The secondary outcome measure of the LEAD study was the time to development of late AMD, defined by multimodal imaging in the non-study eye. The exploratory outcome measures were the rate of change in best-corrected visual acuity (BCVA), low-luminance visual acuity, microperimetric mean sensitivity, drusen volume in the study and non-study eyes, and participant-reported outcomes based on the Night Vision Questionnaire and Impact of Vision Impairment questionnaire.
RESULTS


Progression to late AMD in the non-study eye was not significantly delayed with SNL treatment (hazard ratio, 0.83; 95% confidence interval, 0.40-1.71; P = 0.611). There was no evidence of effect modification based on the coexistence of reticular pseudodrusen; interaction P = 0.065). There was no significant difference between study groups in the rate of change of low-luminance visual acuity, microperimetric mean sensitivity, and drusen volume in the study or non-study eyes, and Night Vision Questionnaire and Impact of Vision Impairment questionnaire scores (all P ≥ 0.167). The rate of BCVA decline was slightly higher for participants in the SNL group compared with the sham treatment group in the study eye (-0.54 and 0.23 letters/year, respectively; P < 0.001) but not the non-study eye (-0.48 and -0.56 letters/year, respectively; P = 0.628).
CONCLUSIONS


Subthreshold nanosecond laser treatment of one eye did not have an effect on delaying progression to late AMD in the fellow eye and did not, in general, have an impact on the exploratory structural, functional, and participant-reported outcomes.",2019,"The rate of BCVA decline was slightly higher for participants in the SNL group compared with the sham treatment group in the study eye (-0.54 and 0.23 letters/year, respectively; P < 0.001) but not the non-study eye (-0.48 and -0.56 letters/year, respectively; P = 0.628).
","['Participants', 'Two-hundred ninety-two patients with bilateral large drusen', 'Early Stages of Age-Related Macular Degeneration (LEAD', 'Age-Related Macular Degeneration']","['Laser Intervention', 'subthreshold nanosecond laser (SNL', 'SNL']","['rate of BCVA decline', 'rate of change in best-corrected visual acuity (BCVA), low-luminance visual acuity, microperimetric mean sensitivity, drusen volume in the study and non-study eyes, and participant-reported outcomes based on the Night Vision Questionnaire and Impact of Vision Impairment questionnaire', 'time to development of late AMD, defined by multimodal imaging in the non-study eye', 'rate of change of low-luminance visual acuity, microperimetric mean sensitivity, and drusen volume in the study or non-study eyes, and Night Vision Questionnaire and Impact of Vision Impairment questionnaire scores']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1260959', 'cui_str': 'Drusen'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0439225', 'cui_str': 'ns'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0234684', 'cui_str': 'Luminance, function (observable entity)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1260959', 'cui_str': 'Drusen'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2350309', 'cui_str': 'Rod Vision'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",292.0,0.235953,"The rate of BCVA decline was slightly higher for participants in the SNL group compared with the sham treatment group in the study eye (-0.54 and 0.23 letters/year, respectively; P < 0.001) but not the non-study eye (-0.48 and -0.56 letters/year, respectively; P = 0.628).
","[{'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia; Ophthalmology, Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia. Electronic address: wu.z@unimelb.edu.au.'}, {'ForeName': 'Chi D', 'Initials': 'CD', 'LastName': 'Luu', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia; Ophthalmology, Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lauren A B', 'Initials': 'LAB', 'LastName': 'Hodgson', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Caruso', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Kate H', 'Initials': 'KH', 'LastName': 'Brassington', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Tindill', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Khin Zaw', 'Initials': 'KZ', 'LastName': 'Aung', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Harper', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia; Ophthalmology, Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sanjeewa S', 'Initials': 'SS', 'LastName': 'Wickremasinghe', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia; Ophthalmology, Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sukhpal S', 'Initials': 'SS', 'LastName': 'Sandhu', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia; Ophthalmology, Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Myra B', 'Initials': 'MB', 'LastName': 'McGuinness', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Fred K', 'Initials': 'FK', 'LastName': 'Chen', 'Affiliation': 'Centre for Ophthalmology and Visual Science (incorporating Lions Eye Institute), The University of Western Australia, Perth, Western Australia, Australia; Department of Ophthalmology, Royal Perth Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': 'Belfast Health and Social Care Trust, Belfast, Northern Ireland.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Arnold', 'Affiliation': 'Marsden Eye Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Wilson J', 'Initials': 'WJ', 'LastName': 'Heriot', 'Affiliation': 'Retinology Institute Victoria, Victoria, Australia.'}, {'ForeName': 'Shane R', 'Initials': 'SR', 'LastName': 'Durkin', 'Affiliation': 'Adelaide Eye and Retina Centre, Adelaide, South Australia, Australia.'}, {'ForeName': 'Maximilian W M', 'Initials': 'MWM', 'LastName': 'Wintergerst', 'Affiliation': 'University of Bonn, Bonn, Germany.'}, {'ForeName': 'Shekoufeh', 'Initials': 'S', 'LastName': 'Gorgi Zadeh', 'Affiliation': 'University of Bonn, Bonn, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schultz', 'Affiliation': 'University of Bonn, Bonn, Germany.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Finger', 'Affiliation': 'University of Bonn, Bonn, Germany.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Cohn', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Baglin', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Pyrawy', 'Initials': 'P', 'LastName': 'Sharangan', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Robyn H', 'Initials': 'RH', 'LastName': 'Guymer', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia; Ophthalmology, Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Retina,['10.1016/j.oret.2019.07.008']
2992,30929590,The role of emotional processing in art therapy (REPAT) for breast cancer patients.,"Emotional awareness and acceptance of emotion are associated with improved health in breast cancer (BC) patients. Art therapy (AT) uses visual art-making for expression and communication and has been shown to reduce psychological and physical symptoms in individuals with cancer. A major objective of AT is to encourage increases in emotion processing; however, few studies examine these changes.  Purpose:  To examine the effect of an eight-week AT group on emotion processing as a mechanism of symptom reduction in women with BC.  Design:  Randomized clinical trial.  Sample:  Twenty women diagnosed with breast cancer whom had completed primary treatment.  Methods:  Participants were randomized to participate in eight-weeks of AT or sham AT, which was a mandala coloring group. Participants answered questionnaires before and after the intervention. We used a Cohen's D calculator for effect sizes and a t-test to examine group differences.  Findings:  Statistically significant between-group differences in emotional awareness and acceptance of emotion were found after the intervention. We found large effect sizes between groups and over time in acceptance of emotion, emotional awareness and depressive symptoms.  Conclusions:  We conclude that emotion processing in AT may be a potential mechanism reducing depression and somatic symptoms in cancer patients.  Implications for Psychosocial Providers:  Art Therapy is a feasible intervention to increase emotional processing. A larger study is required to further examine its effect on psychological and physical symptoms in breast cancer patients.",2019,"FINDINGS


Statistically significant between-group differences in emotional awareness and acceptance of emotion were found after the intervention.","['Participants', 'breast cancer patients', 'cancer patients', 'Psychosocial Providers', 'Twenty women diagnosed with breast cancer whom had completed primary treatment', 'individuals with cancer', 'women with BC', 'breast cancer (BC) patients']",['emotional processing in art therapy (REPAT'],"['emotion processing', 'emotional awareness and acceptance of emotion', 'acceptance of emotion, emotional awareness and depressive symptoms', 'Emotional awareness and acceptance of emotion', 'emotional processing']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0003827', 'cui_str': 'Art Therapy'}]","[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",20.0,0.0571292,"FINDINGS


Statistically significant between-group differences in emotional awareness and acceptance of emotion were found after the intervention.","[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Czamanski-Cohen', 'Affiliation': 'The School of Creative Arts Therapies & The Emili Sagol Creative Arts Therapies Research Center, Faculty of Social Welfare and Health Sciences, University of Haifa , Haifa , Israel.'}, {'ForeName': 'Joshua F', 'Initials': 'JF', 'LastName': 'Wiley', 'Affiliation': 'Monash Institute of Cognitive and Clinical Neurosciences, School of Psychological Sciences, Monash University , Clayton , Victoria , Australia.'}, {'ForeName': 'Noga', 'Initials': 'N', 'LastName': 'Sela', 'Affiliation': 'The Integrative Medicine and Survivorship Clinics, Davidoff Cancer Center, Rabin Medical Center , Petach Tikvah , Israel.'}, {'ForeName': 'Opher', 'Initials': 'O', 'LastName': 'Caspi', 'Affiliation': 'The Integrative Medicine and Survivorship Clinics, Davidoff Cancer Center, Rabin Medical Center , Petach Tikvah , Israel.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Weihs', 'Affiliation': 'The Department of Psychiatry, College of Medicine, University of Arizona , Tucson , Arizona , USA.'}]",Journal of psychosocial oncology,['10.1080/07347332.2019.1590491']
2993,31833000,IM ketorolac vs diclofenac potassium powder for oral solution for the acute treatment of severe migraine: a randomized controlled trial.,"BACKGROUND


Diclofenac potassium for oral solution (CAMBIA®) may be an alternative for patients who would otherwise need to be seen in a healthcare setting for parenteral ketorolac. CAMBIA® is FDA-approved for the abortive treatment of migraine and has demonstrated superiority over generic diclofenac tablets with rapid migraine reduction. This study assessed for efficacy of CAMBIA® as an alternative outpatient treatment for refractory migraine to parenteral ketorolac.
METHODS


We performed an exploratory, single-center, double-blind, double-dummy randomized controlled trial comparing CAMBIA® with IM ketorolac. Participants were randomized to receive either ketorolac 60 mg IM with dummy oral solution or CAMBIA® 50 mg, together with IM injection of normal saline. The primary endpoint was headache severity, self-rated on a scale 0-3. Secondary endpoints included self-rated nausea, disability, and photo- or phonophobia, as well as presence of side effects and need for additional rescue therapy.
RESULTS


A total of 23 patients were enrolled. Ten patients received the study drug and 13 patients received IM ketorolac as the control. There were no major differences observed with respect to the primary outcome of mean headache severity at successive time points over a 24-h follow-up period. No major differences were found with respect to average disability, nausea, and photo- or phonophobia ratings. No major adverse events were reported.
CONCLUSION


In treatment of refractory migraine headache, CAMBIA® may provide similar benefits as IM ketorolac without increasing the risk of treatment failure, major bleeding, or cardiovascular events. However, larger studies are needed to confirm this finding.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT # 02664116, Titled ""IM Ketorolac vs Diclofenac Potassium Powder for Oral Solution (CAMBIA®) for the Acute Treatment of Severe Migraine"". Registered 26 January 2016, https://clinicaltrials.gov/ct2/show/NCT02664116?term=02664116&rank=1.",2020,CAMBIA® is FDA-approved for the abortive treatment of migraine and has demonstrated superiority over generic diclofenac tablets with rapid migraine reduction.,"['patients who would otherwise need to be seen in a healthcare setting for parenteral ketorolac', 'severe migraine', '23 patients were enrolled']","['Diclofenac potassium for oral solution (CAMBIA®', 'diclofenac potassium powder', 'CAMBIA®', 'IM ketorolac', 'CAMBIA® with IM ketorolac', 'ketorolac 60\xa0mg IM with dummy oral solution or CAMBIA® 50\xa0mg, together with IM injection of normal saline', 'Titled ""IM Ketorolac vs Diclofenac Potassium Powder for Oral Solution (CAMBIA®']","['mean headache severity', 'average disability, nausea, and photo- or phonophobia ratings', 'risk of treatment failure, major bleeding, or cardiovascular events', 'headache severity, self-rated on a scale 0-3', 'self-rated nausea, disability, and photo- or phonophobia, as well as presence of side effects and need for additional rescue therapy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}]","[{'cui': 'C0282131', 'cui_str': 'Diclofenac Potassium'}, {'cui': 'C0991536', 'cui_str': 'Oral Solution'}, {'cui': 'C2718733', 'cui_str': 'Cambia'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1273621', 'cui_str': 'Powder for Oral Solution'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0751466', 'cui_str': 'Phonophobia'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0162643'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0222045'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",23.0,0.225106,CAMBIA® is FDA-approved for the abortive treatment of migraine and has demonstrated superiority over generic diclofenac tablets with rapid migraine reduction.,"[{'ForeName': 'Emily Rubenstein', 'Initials': 'ER', 'LastName': 'Engel', 'Affiliation': 'Dalessio Headache Center Scripps Clinic Division of Neurology, 10666 North Torrey Pines Rd. MS 313, La Jolla, CA, 92037, USA. Engel.Emily@scrippshealth.org.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Scripps Green Hospital, SCMG Hospitalists, 10666 N. Torrey Pines Rd, La Jolla, CA, 92037, USA.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-019-04157-y']
2994,31708295,Randomized Study of Systematic Biopsy Versus Magnetic Resonance Imaging and Targeted and Systematic Biopsy in Men on Active Surveillance (ASIST): 2-year Postbiopsy Follow-up.,"BACKGROUND


The initial report from the ASIST trial showed little benefit from targeted biopsy for men on active surveillance (AS) for prostate cancer. Data after 2-yr follow-up are now available for analysis.
OBJECTIVE


To determine if there was a difference in the AS failure rate in a 2-yr follow-up period among men undergoing magnetic resonance imaging (MRI) before initial confirmatory biopsy (CBx) compared to those who did not.
DESIGN, SETTING, AND PARTICIPANTS


This is the 2-yr post-CBx follow-up for the ASIST trial, a prospective, randomized, multicenter, open-label study for men with Gleason grade group (GG) 1 cancer eligible for AS. Patients were randomized to CBx with 12-core systematic sampling or MRI with systematic and targeted sampling.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Patients with GG ≤ 1 on CBx were followed for 2 yr and had MRI and biopsy at that time point. Patients failed AS if they were no longer under AS because of grade progression, clinical progression, subject choice, clinical judgment, treatment, or lost to follow-up. Clinically significant cancer (CSC) was defined as GG ≥ 2.
RESULTS AND LIMITATIONS


In total, 259 men underwent CBx, 132 in the non-MRI and 127 in the MRI arm. After biopsy, 101 men in the non-MRI arm (76%) and 98 in the MRI arm (77%) continued AS. There were fewer men with AS failures in the MRI (19/98, 19%) compared to the non-MRI group (35/101, 35%; p =  0.017). At 2-yr biopsy there were fewer men with CSC in the MRI arm (9.9%, 8/81) than in the non-MRI arm (23%, 17/75; p =  0.048). Significant differences in AS failure rates were detected across the three centers in the MRI arm only (4.2% [2/48] vs 17% [4/24] vs 27% [7/26]; p =  0.019).
CONCLUSIONS


Baseline MRI before CBx during AS results in 50% fewer AS failures and less grade progression over 2 yr. The center where MRI and targeted biopsy is performed may influence AS failure rates.
PATIENT SUMMARY


The ASIST trial randomized 273 men on active surveillance with low-grade prostate cancer diagnosed within the last year to systematic biopsy or magnetic resonance imaging (MRI) with systematic and targeted biopsy. The initial report showed little benefit from targeted biopsy. However, after 2 yr of follow-up we found that baseline MRI before confirmatory biopsy resulted in 50% fewer failures of surveillance and less progression to higher-grade cancer. This confirms the value of MRI in men on surveillance. This study is registered at ClinicalTrials.gov (NCT01354171).",2020,"There were fewer men with AS failures in the MRI (19/98, 19%) compared to the non-MRI group (35/101, 35%; p =  0.017).","['men on active surveillance (AS) for prostate cancer', 'Men on Active Surveillance (ASIST', '259 men underwent CBx, 132 in the non-MRI and 127 in the MRI arm', '273 men on active surveillance with low-grade prostate cancer diagnosed within the last year to systematic biopsy or magnetic resonance imaging (MRI) with systematic and targeted biopsy', 'men with Gleason grade group (GG) 1 cancer eligible for AS']","['Systematic Biopsy Versus Magnetic Resonance Imaging and Targeted and Systematic Biopsy', 'CBx with 12-core systematic sampling or MRI with systematic and targeted sampling', 'magnetic resonance imaging (MRI) before initial confirmatory biopsy (CBx']","['AS failure rates', 'grade progression']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1827061', 'cui_str': 'Active surveillance'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",273.0,0.225363,"There were fewer men with AS failures in the MRI (19/98, 19%) compared to the non-MRI group (35/101, 35%; p =  0.017).","[{'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Klotz', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Canada. Electronic address: laurence.klotz@sunnybrook.ca.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Pond', 'Affiliation': 'McMaster University, Hamilton, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Sugar', 'Affiliation': 'Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Moussa', 'Affiliation': 'University of Western Ontario, London, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Berman', 'Affiliation': ""Queen's University, Kingston, Canada.""}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Van der Kwast', 'Affiliation': 'University Health Network, Toronto, Canada.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Vesprini', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Milot', 'Affiliation': 'Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Kebabdjian', 'Affiliation': 'Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Fleshner', 'Affiliation': 'Princess Margaret Hospital, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Sangheet', 'Initials': 'S', 'LastName': 'Ghai', 'Affiliation': 'Princess Margaret Hospital, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Chin', 'Affiliation': 'University of Western Ontario, London, Canada.'}, {'ForeName': 'Masoom', 'Initials': 'M', 'LastName': 'Haider', 'Affiliation': 'Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada.'}]",European urology,['10.1016/j.eururo.2019.10.007']
2995,32112353,Lessons learned from a pilot randomized clinical trial of home-based exercise prescription before allogeneic hematopoietic cell transplantation.,"Allogeneic hematopoietic cell transplantation (alloHCT) is a life-saving technology that can cure otherwise incurable diseases, but imposes significant physiologic stress upon recipients. This stress leads to short-term toxicity and mid- to long-term physical function impairment in some recipients. Exercise interventions have demonstrated preliminary efficacy in preserving physical function in HCT recipients, but the role of these interventions prior to HCT (prehabilitative) is less known. We tested a 5- to 12-week, prehabilitative higher intensity home-based aerobic exercise intervention in a randomized study of alloHCT candidates. Of 113 patients screened, 34 were randomized to control or intervention groups, 16 underwent pre- and post-intervention peak oxygen consumption (VO 2peak ) testing, and 12 underwent pre- and post-intervention 6-min walk distance (6MWD) testing. No significant differences in VO 2peak  or 6MWD were seen pre- to post-intervention between intervention and control groups, but final numbers of evaluable participants in each group were too small to draw inferences regarding the efficacy of the intervention. We conclude that the design of our prehabilitative intervention was not feasible in this pilot randomized study, and make recommendations regarding the design of future exercise intervention studies in alloHCT.",2020,"No significant differences in VO 2peak  or 6MWD were seen pre- to post-intervention between intervention and control groups, but final numbers of evaluable participants in each group were too small to draw inferences regarding the efficacy of the intervention.","['113 patients screened, 34 were randomized to control or intervention groups, 16 underwent']","['home-based exercise prescription before allogeneic hematopoietic cell transplantation', 'prehabilitative higher intensity home-based aerobic exercise intervention', 'pre- and post-intervention peak oxygen consumption (VO 2peak ) testing, and 12 underwent pre- and post-intervention', 'Allogeneic hematopoietic cell transplantation (alloHCT', 'Exercise interventions']","['6-min walk distance (6MWD', 'VO 2peak  or 6MWD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}]",34.0,0.0488959,"No significant differences in VO 2peak  or 6MWD were seen pre- to post-intervention between intervention and control groups, but final numbers of evaluable participants in each group were too small to draw inferences regarding the efficacy of the intervention.","[{'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Wood', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. wawood@med.unc.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weaver', 'Affiliation': 'Department of Mathematics and Statistics, Elon University, Elon, NC, USA.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Smith-Ryan', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Hanson', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Shea', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Battaglini', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05369-1']
2996,32106713,Long-term follow-up with a smartphone application improves exercise capacity post cardiac rehabilitation: A randomized controlled trial.,"BACKGROUND


Mobile health interventions, especially smartphone applications (apps), have been proposed as promising interventions for supporting adherence to healthy behaviour in patients post cardiac rehabilitation (CR). The overall aim of the study was to examine the effect of individualized follow-up with an app for one year on peak oxygen uptake (VO 2peak ) in patients completing CR.
DESIGN


The study was designed as a single-blinded multicentre randomized controlled trial.
METHODS


The intervention group (IG) received individualized follow-up enabled with an app for one year, while the control group (CG) received usual care. The primary outcome was difference in VO 2peak . Secondary outcomes included exercise performance (time to exhaustion, peak incline (%) and peak velocity (km/h)), bodyweight, resting blood pressure, lipid profile, triglycerides, exercise habits, health-related quality of life, health status and self-perceived goal achievement.
RESULTS


In total, 113 patients completing CR (73.4% with coronary artery disease, 16.8% after valve surgery and 9.8% with other heart diseases) were randomly allocated to the IG or CG. Intention to treat analyses showed a statistically significant difference in VO 2peak  between the groups at follow-up of 2.2 ml/kg/min, 95% confidence interval 0.9-3.5 ( p  < 0.001). Statistically significant differences were also observed in exercise performance, exercise habits and in self-perceived goal achievement.
CONCLUSIONS


Individualized follow-up for one year with an app significantly improved VO 2peak , exercise performance and exercise habits, as well as self-perceived goal achievement, compared with a CG in patients post-CR. There were no statistically significant differences between the groups at follow-up in the other outcome measures evaluated.",2020,"Individualized follow-up for one year with an app significantly improved VO 2peak , exercise performance and exercise habits, as well as self-perceived goal achievement, compared with a CG in patients post-CR.","['post cardiac rehabilitation', 'patients post cardiac rehabilitation (CR', '113 patients completing CR (73.4% with coronary artery disease, 16.8% after valve surgery and 9.8% with other heart diseases', 'patients completing CR']","['individualized follow-up enabled with an app for one year, while the control group (CG) received usual care', 'smartphone application', 'IG or CG']","['VO 2peak', 'VO 2peak , exercise performance and exercise habits, as well as self-perceived goal achievement', 'exercise performance (time to exhaustion, peak incline (%) and peak velocity (km/h)), bodyweight, resting blood pressure, lipid profile, triglycerides, exercise habits, health-related quality of life, health status and self-perceived goal achievement', 'peak oxygen uptake (VO 2peak ', 'exercise capacity', 'VO 2peak ', 'exercise performance, exercise habits and in self-perceived goal achievement']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C4517591', 'cui_str': '16.8 (qualifier value)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}]","[{'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0439494', 'cui_str': 'km/h'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}]",113.0,0.206644,"Individualized follow-up for one year with an app significantly improved VO 2peak , exercise performance and exercise habits, as well as self-perceived goal achievement, compared with a CG in patients post-CR.","[{'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Lunde', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Norway.'}, {'ForeName': 'Asta', 'Initials': 'A', 'LastName': 'Bye', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Norway.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Bergland', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Norway.'}, {'ForeName': 'Jostein', 'Initials': 'J', 'LastName': 'Grimsmo', 'Affiliation': 'Norwegian Heart and Lung Patient Organization, LHL-Hospital Gardermoen, Norway.'}, {'ForeName': 'Even', 'Initials': 'E', 'LastName': 'Jarstad', 'Affiliation': 'Norwegian Sport Medicine Clinic (NIMI), Department of Cardiology and Exercise Physiology, Norway.'}, {'ForeName': 'Birgitta Blakstad', 'Initials': 'BB', 'LastName': 'Nilsson', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Norway.'}]",European journal of preventive cardiology,['10.1177/2047487320905717']
2997,32080000,Effect on Opioids Requirement of Early Administration of Intranasal Ketamine for Acute Traumatic Pain.,"OBJECTIVES


To evaluate the efficacy and safety of early administration of low-dose intranasal ketamine on reducing the need for opioid and nonopioid analgesic agents in emergency department (ED) patients with acute moderate to severe acute limbs' trauma pain.
PATIENTS AND METHODS


This is a double-blind, randomized, prospective, controlled study conducted in the ED. The included patients were randomly assigned to intranasal pulverization of ketamine or placebo. Protocol treatment was given at the triage. The primary outcome is the need for opioids during ED stay. Secondary outcome included the requirement of nonopioid analgesic agents and the percentage of patients discharged from the ED with a visual analog scale (VAS) <30. A combined outcome score including the 3 outcome items was constructed.
RESULTS


The authors included 1102 patients, 550 patients in the placebo group, and 552 in the intranasal ketamine group. The groups were similar regarding demographics, clinical characteristics, and baseline VAS. The need for opioids was decreased in the intranasal ketamine group compared with the placebo group (17.2% vs. 26.5%; P<0.001). The need for nonopioid analgesics was significantly lower in the intranasal ketamine group compared with the placebo group (31.1% vs. 39.6%; P=0.003). The percentage of patients discharged with a VAS score <30 was significantly higher in the intranasal ketamine group (P<0.001). The mean combined outcome score was 0.97 in the placebo group and 0.67 in the intranasal ketamine group (P<0.001).
CONCLUSION


Intranasal ketamine administered early in the triage was associated with a decrease in opioids and nonopioid analgesics need in patients with acute limb trauma-related pain.",2020,Need for opioids was decreased in intranasal ketamine group compared to placebo (17.2% vs. 26.5%; P<0.001).,"['Acute Traumatic Pain', '1102 patients, 550 patients in placebo group, and 552 in intranasal ketamine group', ""emergency department (ED) patients with acute moderate to severe acute limbs' trauma pain"", 'patients with acute limb trauma related pain']","['ketamine or placebo', 'low-dose intranasal ketamine', 'Intranasal ketamine', 'Intranasal Ketamine', 'placebo', 'ketamine', 'intranasal ketamine']","['percentage of patients discharged with VAS score', 'requirement of non-opioid analgesic agents, and percentage of patients discharged from the ED with visual analog scale (VAS) <30', 'efficacy and safety', 'mean combined outcome score', 'need for opioids during ED stay']","[{'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}]","[{'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242937', 'cui_str': 'Non-Opioid Analgesics'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]",1102.0,0.350227,Need for opioids was decreased in intranasal ketamine group compared to placebo (17.2% vs. 26.5%; P<0.001).,"[{'ForeName': 'Wahid', 'Initials': 'W', 'LastName': 'Bouida', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital.'}, {'ForeName': 'Khaoula', 'Initials': 'K', 'LastName': 'Bel Haj Ali', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital.'}, {'ForeName': 'Houda', 'Initials': 'H', 'LastName': 'Ben Soltane', 'Affiliation': 'Research Laboratory LR12SP18, University of Monastir.'}, {'ForeName': 'Mohamed Amine', 'Initials': 'MA', 'LastName': 'Msolli', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Boubaker', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Sekma', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital.'}, {'ForeName': 'Kaouthar', 'Initials': 'K', 'LastName': 'Beltaief', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital.'}, {'ForeName': 'Mohamed Habib', 'Initials': 'MH', 'LastName': 'Grissa', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Methamem', 'Affiliation': 'Emergency Department, Farhat Hached University Hospital.'}, {'ForeName': 'Riadh', 'Initials': 'R', 'LastName': 'Boukef', 'Affiliation': 'Research Laboratory LR12SP18, University of Monastir.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Belguith', 'Affiliation': 'Epidemiology and Preventive Medicine Department, University Hospital of Monastir, Monastir.'}, {'ForeName': 'Semir', 'Initials': 'S', 'LastName': 'Nouira', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000821']
2998,32078058,Cost-effectiveness analysis of voice rehabilitation for patients with laryngeal cancer: a randomized controlled study.,"INTRODUCTION


Voice problems are common following radiotherapy for laryngeal cancer. Few studies exist covering the effect of voice rehabilitation, and no previous studies exist regarding the cost of said rehabilitation. This randomized controlled study aimed to analyze the cost-effectiveness of voice rehabilitation after radiotherapy for patients with laryngeal cancer.
MATERIAL AND METHODS


A total of 66 patients with laryngeal cancer with follow-up data 12 months post-radiotherapy were included. Patients were randomized into receiving either voice rehabilitation (n = 32) or no voice rehabilitation (n = 34). The patient outcome was measured as quality-adjusted life years (QALYs). The index range between 0 and 1, where 0 equals death and 1 represents perfect health. The QALYs were assessed with the European Organization for Research and Treatment of Cancer questionnaire QLQ-C30 mapped to EuroQoL 5 Dimension values. The cost of rehabilitation and other healthcare visits was derived from hospital systems. The patients reported the total amount of sick leave days during the first 12 months following radiotherapy. The cost-effectiveness of the voice rehabilitation was compared with no rehabilitation intervention based on the incremental cost-effectiveness ratio.
RESULTS


The cost per gained QALY with voice rehabilitation compared to no rehabilitation from a societal perspective was - 27,594 € (SEK - 250,852) which indicates that the voice rehabilitation is a cost-saving alternative compared to no rehabilitation due to lower costs and a slightly better health outcome. From a healthcare perspective, the voice rehabilitation indicates a cost 60,800 € (SEK 552,725) per gained QALY.
CONCLUSION


From a societal perspective, i.e., including the costs of production loss, voice rehabilitation compared to no voice rehabilitation following radiotherapy for laryngeal cancer seems to be cost-saving. When analyzing only the healthcare costs in relation to health outcomes, voice rehabilitation indicates an incremental cost of 60,800 € per gained QALY, which is just above the threshold of the maximum willingness to pay level.",2020,"The cost per gained QALY with voice rehabilitation compared to no rehabilitation from a societal perspective was - 27,594 € (SEK - 250,852) which indicates that the voice rehabilitation is a cost-saving alternative compared to no rehabilitation due to lower costs and a slightly better health outcome.","['patients with laryngeal cancer', '66 patients with laryngeal cancer with follow-up data 12\xa0months post-radiotherapy were included']","['voice rehabilitation after radiotherapy', 'voice rehabilitation (n\u2009=\u200932) or no voice rehabilitation', 'radiotherapy', 'voice rehabilitation']","['cost-effectiveness', 'total amount of sick leave days', 'quality-adjusted life years (QALYs', 'cost of rehabilitation and other healthcare visits']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007107', 'cui_str': 'Cancer of Larynx'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]",66.0,0.0321077,"The cost per gained QALY with voice rehabilitation compared to no rehabilitation from a societal perspective was - 27,594 € (SEK - 250,852) which indicates that the voice rehabilitation is a cost-saving alternative compared to no rehabilitation due to lower costs and a slightly better health outcome.","[{'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Johansson', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at the Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Finizia', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Josefine', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': 'Health Economics and Policy, School of Public Health and Community Medicine, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tuomi', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden. lisa.tuomi@gu.se.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05362-8']
2999,32077321,Effects of a brief interpersonal conflict cognitive reappraisal intervention on improvements in access to emotion regulation strategies and depressive symptoms in college students.,"Objective:  Research has demonstrated relative success with brief interventions that utilize social psychological theory to target the root cause of unwanted behaviours. Given the intersections among anxious attachment, depression, and emotion dysregulation, the current research utilises an interpersonal conflict cognitive reappraisal intervention to evaluate improvements in depressive symptoms. We also evaluated mediation via improvements in emotion regulation and moderation by attachment anxiety.  Design:  Undergraduates ( N  = 260) completed a baseline assessment and were randomised to one of four writing conditions: An interpersonal conflict from (a) their own perspective; (b) the other party's perspective; or (c) a neutral, third-party perspective (primary experimental condition) or about their day (control condition). They also completed a follow-up survey online two weeks later.  Main outcome measures  included limited access to emotion regulation strategies and depressive symptoms.  Results:  Consistent with hypotheses, compared to control, participants who adopted the perspective of neutral third party reported improvements in access to emotion regulation strategies. There was also a significant indirect effect on depressive symptoms through changes in strategies. Finally, improving strategies led to a reduction in depressive symptoms, especially for those higher in attachment anxiety.  Conclusion:  We present promising emerging results for a single-session, conflict-focused, brief cognitive reappraisal intervention on changes in emotion regulation and depressive symptoms.",2020,"Results:  Consistent with hypotheses, compared to control, participants who adopted the perspective of neutral third party reported improvements in access to emotion regulation strategies.","['college students', 'Undergraduates ( N \u2009=\u2009260']","['cognitive reappraisal intervention', 'interpersonal conflict cognitive reappraisal intervention', ""interpersonal conflict from (a) their own perspective; (b) the other party's perspective; or (c) a neutral, third-party perspective (primary experimental condition) or about their day (control condition""]","['anxious attachment, depression, and emotion dysregulation', 'emotion regulation strategies and depressive symptoms', 'emotion regulation and moderation by attachment anxiety', 'emotion regulation and depressive symptoms', 'depressive symptoms', 'limited access to emotion regulation strategies and depressive symptoms']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}]","[{'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]",,0.0601253,"Results:  Consistent with hypotheses, compared to control, participants who adopted the perspective of neutral third party reported improvements in access to emotion regulation strategies.","[{'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, University of South Florida St. Petersburg, St. Petersburg, FL, USA.'}, {'ForeName': 'Katherine D M', 'Initials': 'KDM', 'LastName': 'Lee', 'Affiliation': 'Department of Psychology, University of New Hampshire, Durham, NH, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Onufrak', 'Affiliation': 'Department of Psychology, University of South Florida St. Petersburg, St. Petersburg, FL, USA.'}, {'ForeName': 'Jaclyn B', 'Initials': 'JB', 'LastName': 'Dell', 'Affiliation': 'Department of Psychology, University of South Florida St. Petersburg, St. Petersburg, FL, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Quist', 'Affiliation': 'Department of Psychology, Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Hunter P', 'Initials': 'HP', 'LastName': 'Drake', 'Affiliation': 'Department of Psychology, University of South Florida St. Petersburg, St. Petersburg, FL, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bryan', 'Affiliation': 'VA South Central Mental Illness Research, Education and Clinical Center, Houston, TX, USA.'}]",Psychology & health,['10.1080/08870446.2019.1711090']
3000,32077361,"Randomized phase 1 study of sequential (""primed"") vs. concurrent decitabine in combination with cladribine, cytarabine, G-CSF, and mitoxantrone (CLAG-M) in adults with newly diagnosed or relapsed/refractory acute myeloid leukemia (AML) or other high-grade myeloid neoplasm.",,2020,,['adults with newly diagnosed or relapsed/refractory acute myeloid leukemia (AML) or other high-grade myeloid neoplasm'],"['sequential (""primed"") vs. concurrent decitabine', 'cladribine, cytarabine, G-CSF, and mitoxantrone (CLAG-M']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C2939461', 'cui_str': 'Myeloid neoplasm'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}]",[],,0.0417158,,"[{'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Palmieri', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center/University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Buckley', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center/University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Othus', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Anna B', 'Initials': 'AB', 'LastName': 'Halpern', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center/University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Mary-Elizabeth M', 'Initials': 'MM', 'LastName': 'Percival', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center/University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Scott', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center/University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Hendrie', 'Affiliation': 'Department of Medicine, Division of Hematology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Becker', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center/University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Vivian G', 'Initials': 'VG', 'LastName': 'Oehler', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center/University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Elihu H', 'Initials': 'EH', 'LastName': 'Estey', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center/University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Roland B', 'Initials': 'RB', 'LastName': 'Walter', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center/University of Washington, Seattle, WA, USA.'}]",Leukemia & lymphoma,['10.1080/10428194.2020.1728754']
3001,31736357,Results of the FUEL Trial.,"BACKGROUND


The Fontan operation creates a total cavopulmonary connection, a circulation in which the importance of pulmonary vascular resistance is magnified. Over time, this circulation leads to deterioration of cardiovascular efficiency associated with a decline in exercise performance. Rigorous clinical trials aimed at improving physiology and guiding pharmacotherapy are lacking.
METHODS


The FUEL trial (Fontan Udenafil Exercise Longitudinal) was a phase III clinical trial conducted at 30 centers. Participants were randomly assigned udenafil, 87.5 mg twice daily, or placebo in a 1:1 ratio. The primary outcome was the between-group difference in change in oxygen consumption at peak exercise. Secondary outcomes included between-group differences in changes in submaximal exercise at the ventilatory anaerobic threshold, the myocardial performance index, the natural log of the reactive hyperemia index, and serum brain-type natriuretic peptide.
RESULTS


Between 2017 and 2019, 30 clinical sites in North America and the Republic of Korea randomly assigned 400 participants with Fontan physiology. The mean age at randomization was 15.5±2 years; 60% of participants were male, and 81% were white. All 400 participants were included in the primary analysis with imputation of the 26-week end point for 21 participants with missing data (11 randomly assigned to udenafil and 10 to placebo). Among randomly assigned participants, peak oxygen consumption increased by 44±245 mL/min (2.8%) in the udenafil group and declined by 3.7±228 mL/min (-0.2%) in the placebo group ( P =0.071). Analysis at ventilatory anaerobic threshold demonstrated improvements in the udenafil group versus the placebo group in oxygen consumption (+33±185 [3.2%] versus -9±193 [-0.9%] mL/min,  P =0.012), ventilatory equivalents of carbon dioxide (-0.8 versus -0.06,  P =0.014), and work rate (+3.8 versus +0.34 W,  P =0.021). There was no difference in change of myocardial performance index, the natural log of the reactive hyperemia index, or serum brain-type natriuretic peptide level.
CONCLUSIONS


In the FUEL trial, treatment with udenafil (87.5 mg twice daily) was not associated with an improvement in oxygen consumption at peak exercise but was associated with improvements in multiple measures of exercise performance at the ventilatory anaerobic threshold.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT02741115.",2020,"Among randomized participants, peak oxygen consumption increased by 44 ±245 mL/min (2.8%) in the udenafil group and declined by 3.7 ±228 mL/min (-0.2%) in the placebo group (p=0.071).","['All 400 participants were included in the primary analysis with imputation of the 26-week endpoint for 21 participants with missing data (11 randomized to udenafil and 10 to', 'Between 2017 and 2019, 30 clinical sites in North America and the Republic of Korea randomized 400 participants with Fontan physiology', '30 centers', 'The mean age at randomization was 15.5 ±2 years; 60% of participants were male and 81% were White']","['placebo', 'Fontan Udenafil Exercise Longitudinal (FUEL', 'udenafil']","['oxygen consumption', 'changes in sub-maximal exercise at the ventilatory anaerobic threshold (VAT), the myocardial performance index (MPI), the natural log of the reactive hyperemia index (lnRHI), and serum brain-type natriuretic peptide (BNP', 'change in oxygen consumption at peak exercise', 'ventilatory equivalents of carbon dioxide', 'change of MPI, lnRHI, or serum BNP level', 'work rate', 'peak oxygen consumption']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1742789', 'cui_str': '3-(1-Methyl-7-oxo-3-propyl-4,7-dihydro-1H-pyrazolo(4,3-d)pyrimidin-5-yl)-N-(2-(1-methyl-2-pyrrolidinyl)ethyl)-4-propoxybenzenesulfonamide'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1742789', 'cui_str': '3-(1-Methyl-7-oxo-3-propyl-4,7-dihydro-1H-pyrazolo(4,3-d)pyrimidin-5-yl)-N-(2-(1-methyl-2-pyrrolidinyl)ethyl)-4-propoxybenzenesulfonamide'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0556991', 'cui_str': 'Fuel (substance)'}]","[{'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043227', 'cui_str': 'Work'}]",400.0,0.492881,"Among randomized participants, peak oxygen consumption increased by 44 ±245 mL/min (2.8%) in the udenafil group and declined by 3.7 ±228 mL/min (-0.2%) in the placebo group (p=0.071).","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Goldberg', 'Affiliation': ""Division of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, PA (D.J.G., S.W., M.G.M., S.M.P.).""}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Zak', 'Affiliation': 'New England Research Institutes, Watertown, MA (V.Z.).'}, {'ForeName': 'Bryan H', 'Initials': 'BH', 'LastName': 'Goldstein', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, OH (B.H.G., M.S.H., K.A.R., E.M.U.).""}, {'ForeName': 'Kurt R', 'Initials': 'KR', 'LastName': 'Schumacher', 'Affiliation': ""Division of Cardiology, C.S. Mott Children's Hospital, Ann Arbor, MI (K.R.S., M.W.R.).""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rhodes', 'Affiliation': ""Department of Cardiology, Children's Hospital Boston, MA (J.R.).""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Penny', 'Affiliation': ""Division of Cardiology, Texas Children's Hospital, Baylor College of Medicine, Houston, TX (D.J.P.).""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Petit', 'Affiliation': ""Emory University School of Medicine, Children's Healthcare of Atlanta, GA (C.J.P.).""}, {'ForeName': 'Salil', 'Initials': 'S', 'LastName': 'Ginde', 'Affiliation': ""Division of Cardiology, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee (S.G., P.C.F.).""}, {'ForeName': 'Shaji C', 'Initials': 'SC', 'LastName': 'Menon', 'Affiliation': 'Division of Pediatric Cardiology, University of Utah, Salt Lake City (S.C.M.).'}, {'ForeName': 'Seong-Ho', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Pediatrics, Sejong General Hospital, Bucheon-Si, South Korea (S.-H.K.).'}, {'ForeName': 'Gi Beom', 'Initials': 'GB', 'LastName': 'Kim', 'Affiliation': ""Seoul National University School of Medicine, Seoul National University Children's Hospital, South Korea (G.B.K.).""}, {'ForeName': 'Todd T', 'Initials': 'TT', 'LastName': 'Nowlen', 'Affiliation': ""Heart Center, Phoenix Children's Hospital, AZ (T.T.N.).""}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'DiMaria', 'Affiliation': ""Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (M.V.D.).""}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Frischhertz', 'Affiliation': 'Division of Cardiology, Vanderbilt University School of Medicine, Nashville, TN (B.P.F.).'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Wagner', 'Affiliation': ""Divisions of Cardiology and Clinical Pharmacology, Children's Mercy Kansas City, MO (J.B.W.).""}, {'ForeName': 'Kimberly E', 'Initials': 'KE', 'LastName': 'McHugh', 'Affiliation': 'Division of Pediatric Cardiology, Medical University of South Carolina, Charleston (K.E.M.).'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'McCrindle', 'Affiliation': 'Division of Cardiology, The Hospital for Sick Children, University of Toronto, Ontario (B.W.M.).'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Shillingford', 'Affiliation': 'Nemours Cardiac Center, Nemours/Alfred I. DuPont Hospital for Children, Wilmington, DE (A.J.S.).'}, {'ForeName': 'Arash A', 'Initials': 'AA', 'LastName': 'Sabati', 'Affiliation': ""Los Angeles Children's Hospital, Division of Cardiology, CA (A.A.S.).""}, {'ForeName': 'Anji T', 'Initials': 'AT', 'LastName': 'Yetman', 'Affiliation': ""Children's Hospital and Medical Center, University of Nebraska, Omaha (A.T.Y.).""}, {'ForeName': 'Anitha S', 'Initials': 'AS', 'LastName': 'John', 'Affiliation': ""Division of Cardiology, Children's National Health System, Washington, DC (A.S.J.).""}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Richmond', 'Affiliation': ""Division of Pediatric Cardiology, Morgan Stanley Children's Hospital, Columbia University Medical Center, New York, NY (M.E.R.).""}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Files', 'Affiliation': ""Division of Cardiology, Seattle Children's Hospital, WA (M.D.F.).""}, {'ForeName': 'R Mark', 'Initials': 'RM', 'LastName': 'Payne', 'Affiliation': 'Division of Cardiology, Riley Hospital for Children, Indianapolis, IN (R.M.P.).'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Mackie', 'Affiliation': ""Division of Cardiology, Stollery Children's Hospital, Edmonton, Alberta, Canada (A.S.M.).""}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Davis', 'Affiliation': ""Division of Cardiology, Rady Children's Hospital, San Diego, CA (C.K.D.).""}, {'ForeName': 'Shabana', 'Initials': 'S', 'LastName': 'Shahanavaz', 'Affiliation': ""Division of Cardiology, St Louis Children's Hospital, MO (S.S.).""}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Hill', 'Affiliation': ""Duke Children's Pediatric and Congenital Heart Center, Durham, NC (K.D.H.).""}, {'ForeName': 'Ruchira', 'Initials': 'R', 'LastName': 'Garg', 'Affiliation': 'Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA (R.G.).'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Jacobs', 'Affiliation': ""Johns Hopkins All Children's Hospital, Department of Surgery, St Petersburg, FL (J.P.J.).""}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Hamstra', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, OH (B.H.G., M.S.H., K.A.R., E.M.U.).""}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Woyciechowski', 'Affiliation': ""Division of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, PA (D.J.G., S.W., M.G.M., S.M.P.).""}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Rathge', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, OH (B.H.G., M.S.H., K.A.R., E.M.U.).""}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'McBride', 'Affiliation': ""Division of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, PA (D.J.G., S.W., M.G.M., S.M.P.).""}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Frommelt', 'Affiliation': ""Division of Cardiology, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee (S.G., P.C.F.).""}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Russell', 'Affiliation': ""Division of Cardiology, C.S. Mott Children's Hospital, Ann Arbor, MI (K.R.S., M.W.R.).""}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Urbina', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, OH (B.H.G., M.S.H., K.A.R., E.M.U.).""}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Yeager', 'Affiliation': 'Consultant to Mezzion Pharma Co Ltd, Mezzion Pharma Co Ltd, Seoul, South Korea (J.L.Y.).'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Pemberton', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (V.L.P., M.P.S., G.D.P.).'}, {'ForeName': 'Mario P', 'Initials': 'MP', 'LastName': 'Stylianou', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (V.L.P., M.P.S., G.D.P.).'}, {'ForeName': 'Gail D', 'Initials': 'GD', 'LastName': 'Pearson', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (V.L.P., M.P.S., G.D.P.).'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Paridon', 'Affiliation': ""Division of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, PA (D.J.G., S.W., M.G.M., S.M.P.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.044352']
3002,31389909,Effects of Exercise Training and Statin Use in People Living with HIV with Dyslipidemia.,"PURPOSE


To evaluate the effects of the combination of ET and statins in people living with HIV.
METHODS


This was a randomized, double-blind, placebo-controlled clinical trial. Eighty-three people living with HIV were assigned to either placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET) groups. Volunteers assigned to STA and STAET groups were administered 10 mg of rosuvastatin, whereas the PL and PLET groups were administered a placebo. PLET and STAET groups performed ET three times a week. Before and after the 12-week follow-up, the volunteers underwent to anthropometric assessment and blood collection to evaluate lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests were performed.
RESULTS


There was a decrease in total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT) in the STA, PLET, and STAET groups compared to PL group (p<0.001). Furthermore, there was a decrease in TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels in the STAET groups compared to the STA (p<0.001) and PLET groups (p<0.001). There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001). The PLET and STAET groups reduced body fat mass, body fat percentage and increased lean body mass, MS and CF compared to PL (p<0.001) and STA (p<0.001) groups.
CONCLUSION


The combination of ET and statins is useful to enhance lipid and inflammatory profiles, reduce CVD markers, and improve Doppler ultrasound findings, MS and CF in people living with HIV.",2019,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","['people living with HIV', 'People Living with HIV with Dyslipidemia', 'Eighty-three people living with HIV']","['STA', 'placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET', 'rosuvastatin', 'Exercise Training and Statin Use', 'placebo', 'PLET', 'ET and statins']","['TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels', 'lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests', 'IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate', 'body fat mass, body fat percentage and increased lean body mass, MS and CF', 'total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C4517888', 'cui_str': '83'}]","[{'cui': 'C1529286', 'cui_str': 'stas'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}]",83.0,0.0940275,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","[{'ForeName': 'Hugo Ribeiro', 'Initials': 'HR', 'LastName': 'Zanetti', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Master Institute of Education President Antônio Carlos, Araguari/MG, Brazil.'}, {'ForeName': 'Leandro Teixeira', 'Initials': 'LT', 'LastName': 'Paranhos Lopes', 'Affiliation': 'Brazil University, Fernandópolis/SP, Brazil.'}, {'ForeName': 'Edmar Lacerda', 'Initials': 'EL', 'LastName': 'Mendes', 'Affiliation': 'Institute of Health Sciences, Department of Sport Sciences, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Roever', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Mário Leon', 'Initials': 'ML', 'LastName': 'Silva-Vergara', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Fernando Freitas', 'Initials': 'FF', 'LastName': 'Neves', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Elmiro Santos', 'Initials': 'ES', 'LastName': 'Resende', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002120']
3003,31372917,Effect and Safety of CX-DZ-II Intelligent Electroacupuncture Therapeutic Instrument for Neck Pain Caused by Cervical Spondylos: Study Protocol for A Randomized Controlled Trial.,"BACKGROUND


Neck pain caused by cervical spondylosis (CS) is a chronic pain condition, with an increasingly high incidence in the general population. Electroacupuncture is a common analgesic modality that has been widely applied in neck pain treatment. However, current electroacupuncture instruments used in the clinic have low intelligence levels and obscure parameter standards. We here designed this study for assessing the effect and safety of a new, intelligent electroacupuncture instrument, the CX-DZ-II, in treating neck pain.
METHODS


The present study is a prospective, two-center, randomized, controlled, open-label, non-inferiority trial for CX-DZ-II on treating neck pain caused by CS. Totally 160 eligible patients will be included in this trial and randomly assigned to an experimental group and a control group in a 1:1 ratio. A semi-standard acupoint selection strategy will be employed. In the experimental group, selected acupoints will be stimulated by CX-DZ-II. Electroacupuncture treatment will be accomplished by a pre-existing electroacupuncture instrument in the control group. The duration of treatment will be 2 weeks. The primary outcome is the change of Visual Analog Scale (VAS) score after one course of treatment. The secondary outcomes include the VAS scores after each treatment, the responder rate, drug-usage rate of non-steroidal antipyretic analgesics, the rate of adverse events occurrence, and the performance of instrument.
DISCUSSION


This study will evaluate the effect and safety of the CX-DZ-II intelligent electroacupuncture therapeutic instrument in comparison with a pre-existing non-intelligent instrument in the treatment of neck pain caused by CS. The results will hopefully demonstrate a more optimal electroacupuncture instrument for the treatment of neck pain. (Trial registration No. gov NCT03005301).",2020,"The secondary outcomes include the VAS scores after each treatment, the responder rate, drug-usage rate of non-steroidal antipyretic analgesics, the rate of adverse events occurrence, and the performance of instrument.
","['Neck Pain', 'Totally 160 eligible patients', 'Neck pain caused by cervical spondylosis (CS']","['Electroacupuncture', 'CX-DZ-II intelligent electroacupuncture therapeutic', 'CX-DZ-II Intelligent Electroacupuncture Therapeutic Instrument']","['responder rate, drug-usage rate of non-steroidal antipyretic analgesics, the rate of adverse events occurrence, and the performance of instrument', 'VAS scores', 'change of Visual Analog Scale (VAS) score']","[{'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1384641', 'cui_str': 'Cervical spondylosis (disorder)'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0003419', 'cui_str': 'Antipyretic Agents'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",160.0,0.12216,"The secondary outcomes include the VAS scores after each treatment, the responder rate, drug-usage rate of non-steroidal antipyretic analgesics, the rate of adverse events occurrence, and the performance of instrument.
","[{'ForeName': 'Zhi-Han', 'Initials': 'ZH', 'LastName': 'Chen', 'Affiliation': 'School of Acupuncture Moxibustion and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.'}, {'ForeName': 'Fan-Rong', 'Initials': 'FR', 'LastName': 'Liang', 'Affiliation': 'School of Acupuncture Moxibustion and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.'}, {'ForeName': 'Ming-Xiao', 'Initials': 'MX', 'LastName': 'Yang', 'Affiliation': 'School of Chinese Medicine, University of Hong Kong Li Ka Shing Faculty of Medicine, Hong Kong SAR, China.'}, {'ForeName': 'De-Hua', 'Initials': 'DH', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'School of Acupuncture Moxibustion and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.'}, {'ForeName': 'Yu-Lan', 'Initials': 'YL', 'LastName': 'Ren', 'Affiliation': 'School of Chinese Classics, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China. renxg2468@163.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-019-3038-2']
3004,31652392,Ultra-short duration direct acting antiviral prophylaxis to prevent virus transmission from hepatitis C viremic donors to hepatitis C negative kidney transplant recipients.,"We conducted an adaptive design single-center pilot trial between October 2017 and November 2018 to determine the safety and efficacy of ultra-short-term perioperative pangenotypic direct acting antiviral (DAA) prophylaxis for deceased hepatitis C virus (HCV)-nucleic acid test (NAT) positive donors to HCV negative kidney recipients (D+/R-). In Group 1, 10 patients received one dose of SOF/VEL (sofusbuvir/velpatasvir) pretransplant and one dose on posttransplant Day 1. In Group 2A (N = 15) and the posttrial validation (Group 2B; N = 25) phase, patients received two additional SOF/VEL doses (total 4) on Days 2 and 3 posttransplant. Development of posttransplant HCV transmission triggered 12-week DAA therapy. For available donor samples (N = 27), median donor viral load was 1.37E + 06 IU/mL (genotype [GT]1a: 70%; GT2: 7%; GT3: 23%). Overall viral transmission rate was 12% (6/50; Group 1:30% [3/10]; Group 2A:13% [2/15]; Group 2B:4% [1/25]). For the 6 viremic patients, 5 (83%) achieved sustained virologic response (3 with first-line DAA therapy; and two after retreatment with second-line DAA). At a median follow-up of 8 months posttransplant, overall patient and allograft survivals were 98%, respectively. The 4-day strategy reduced viral transmission to 7.5% (3/40; 95% confidence interval [CI]: 1.8%-20.5%) and could result in avoidance of prolonged posttransplant DAA therapy for most D+/R - transplants.",2020,The 4-day strategy reduced viral transmission to 7.5% (3/40; 95% CI: 1.8-20.5%) and could result in avoidance of prolonged post-transplant DAA therapy for most D+/R- transplants.,"['hepatitis C viremic donors to hepatitis c negative kidney transplant recipients', 'deceased hepatitis C virus (HCV)-nucleic acid test (NAT) positive donors to HCV negative kidney recipients (D+/R']","['SOF/VEL (sofusbuvir/velpatasvir) pre-transplant and one dose on post-transplant Day 1', 'additional SOF/VEL', 'Ultra-short duration direct acting anti-viral prophylaxis', 'ultra-short-term peri-operative pangenotypic direct acting antiviral (DAA) prophylaxis']","['sustained virologic response', 'viral transmission', 'median donor viral load', 'overall patient and allograft survivals', 'Overall viral transmission rate']","[{'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0220847', 'cui_str': 'Hepatitis C virus'}, {'cui': 'C0028606', 'cui_str': 'Nucleic Acids'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C4079582', 'cui_str': 'velpatasvir'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0877137', 'cui_str': 'Antiviral prophylaxis'}]","[{'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0301035,The 4-day strategy reduced viral transmission to 7.5% (3/40; 95% CI: 1.8-20.5%) and could result in avoidance of prolonged post-transplant DAA therapy for most D+/R- transplants.,"[{'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Gupta', 'Affiliation': 'Division of Nephrology, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'Idris', 'Initials': 'I', 'LastName': 'Yakubu', 'Affiliation': 'Virginia Commonwealth University School of Pharmacy, Richmond, Virginia.'}, {'ForeName': 'Chandra S', 'Initials': 'CS', 'LastName': 'Bhati', 'Affiliation': 'Division of Transplantation, Hume-Lee Transplant Center, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacotherapy and Outcomes Science, Virginia Commonwealth University School of Pharmacy, Richmond, Virginia.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Patterson', 'Affiliation': 'Department of Pharmacotherapy and Outcomes Science, Virginia Commonwealth University School of Pharmacy, Richmond, Virginia.'}, {'ForeName': 'Ayana', 'Initials': 'A', 'LastName': 'Andrews-Joseph', 'Affiliation': 'Division of Transplantation, Hume-Lee Transplant Center, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'Anam', 'Initials': 'A', 'LastName': 'Alam', 'Affiliation': 'Division of Nephrology, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ferreira-Gonzalez', 'Affiliation': 'Department of Pathology, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Dhiren', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Division of Nephrology, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'Irfan K', 'Initials': 'IK', 'LastName': 'Moinuddin', 'Affiliation': 'Division of Nephrology, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'Layla', 'Initials': 'L', 'LastName': 'Kamal', 'Affiliation': 'Division of Nephrology, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'King', 'Affiliation': 'Division of Nephrology, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'Marlon', 'Initials': 'M', 'LastName': 'Levy', 'Affiliation': 'Division of Transplantation, Hume-Lee Transplant Center, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Division of Transplantation, Hume-Lee Transplant Center, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Cotterell', 'Affiliation': 'Division of Transplantation, Hume-Lee Transplant Center, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'Trevor W', 'Initials': 'TW', 'LastName': 'Reichman', 'Affiliation': 'Division of Transplantation, Hume-Lee Transplant Center, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'Aamir', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Division of Transplantation, Hume-Lee Transplant Center, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Kimball', 'Affiliation': 'Division of Transplantation, Hume-Lee Transplant Center, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Stiltner', 'Affiliation': 'Virginia Commonwealth University School of Pharmacy, Richmond, Virginia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Baldecchi', 'Affiliation': 'Division of Transplantation, Hume-Lee Transplant Center, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Brigle', 'Affiliation': 'Division of Transplantation, Hume-Lee Transplant Center, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Gehr', 'Affiliation': 'Division of Nephrology, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Sterling', 'Affiliation': 'Division of Transplantation, Hume-Lee Transplant Center, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15664']
3005,30121097,"Talking with teens about traffic safety: Initial feasibility, acceptability, and efficacy of a parent-targeted intervention for primary care settings.","INTRODUCTION


The aims of the current pilot study were to evaluate the feasibility, acceptability, and preliminary efficacy of the Talking with Teens about Traffic Safety Program. The program consists of a clinic-based health coaching session with parents of adolescents at their annual well-child visit to promote parent-teen communication about teen driver safety including: a Parent Handbook that is designed to serve as a primer on teen driver safety and facilitate parent-teen communication on a variety of teen driver topics; an interactive practice driving toolset; and an endorsement of the materials by the primary care provider.
METHOD


Fifty-four parent-teen dyads (n = 108 total) were recruited from a primary care practice. Dyads were randomized (1:1) into a treatment group or a usual care group. Implementation fidelity was assessed using checklists completed by health coaches and parent interviews. After 6 months, parents reported how often they talked with their teen about 12 safe driving topics (e.g., state graduated driver licensing laws).
RESULTS


Parents in the treatment group reported more frequent discussions than parents in the control group on 7 out of the 12 topics. Fidelity data indicate that 100% of sessions were implemented as designed and were acceptable to parents.
CONCLUSIONS


The program was feasible to administer and there was evidence for preliminary efficacy. Generally, effects were larger for more infrequently discussed topics, which is to be expected due to the potential for ceiling effects on more commonly discussed topics (e.g., distracted driving). A larger multi-site study is warranted.
PRACTICAL APPLICATIONS


The results from this pilot study provide support for implementation fidelity and establish a proof-of-concept for the Talking with Teens about Traffic Safety Program. The results provide guidance for developing partnerships with pediatricians and parents to develop parent-teen communication interventions on injury prevention topics.",2018,"RESULTS


Parents in the treatment group reported more frequent discussions than parents in the control group on 7 out of the 12 topics.",['Fifty-four parent-teen dyads (n\u202f=\u202f108 total) were recruited from a primary care practice'],"['clinic-based health coaching session with parents of adolescents at their annual well-child visit to promote parent-teen communication about teen driver safety including: a Parent Handbook', 'usual care group']","['Implementation fidelity', 'frequent discussions', 'feasibility, acceptability']","[{'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1444717', 'cui_str': 'Well child visit'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0596654', 'cui_str': 'Handbooks'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0205186,"RESULTS


Parents in the treatment group reported more frequent discussions than parents in the control group on 7 out of the 12 topics.","[{'ForeName': 'Jessica H', 'Initials': 'JH', 'LastName': 'Mirman', 'Affiliation': 'The University of Alabama at Birmingham, Department of Psychology, 1720 2nd Avenue South, Birmingham, AL 35294, USA. Electronic address: jhmirman@uab.edu.'}, {'ForeName': 'Emma S', 'Initials': 'ES', 'LastName': 'Goodman', 'Affiliation': 'The University of Alabama at Birmingham, Department of Psychology, 1720 2nd Avenue South, Birmingham, AL 35294, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Friedrich', 'Affiliation': ""Division of Adolescent Medicine, Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Children's Hospital of Philadelphia, 3401 Civic Center Blvd., 11th floor, Main Building, Suite 11NW10, Philadelphia, PA 19104, USA.""}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Ford', 'Affiliation': ""Division of Adolescent Medicine, Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Children's Hospital of Philadelphia, 3401 Civic Center Blvd., 11th floor, Main Building, Suite 11NW10, Philadelphia, PA 19104, USA.""}]",Journal of safety research,['10.1016/j.jsr.2018.06.008']
3006,31831295,Randomised Clinical Trial of Prostatic Artery Embolisation Versus a Sham Procedure for Benign Prostatic Hyperplasia.,"BACKGROUND


Prostatic artery embolisation (PAE) has been associated with an improvement of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH), but conclusive evidence of efficacy from randomised controlled clinical trials has been lacking.
OBJECTIVE


To assess the safety and efficacy of PAE compared with a sham procedure in the treatment of LUTS/BPH.
DESIGN, SETTING, AND PARTICIPANTS


A randomised, single-blind, sham-controlled superiority clinical trial was conducted in 80 males ≥45yr with severe LUTS/BPH refractory to medical treatment from 2014 to 2019 in a private clinic, with efficacy assessments at 6 and 12 mo after randomisation. One patient in the PAE group and three in the sham group did not complete the study.
INTERVENTION


Patients were randomised 1:1 upon successful catheterisation of a prostatic artery to either PAE or a sham PAE procedure without embolisation. After 6 mo, all 38 patients randomised to the sham group who completed the single-blind period underwent PAE, and both groups completed a 6-mo open period.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


An intention-to-treat analysis of all randomised patients was performed. The coprimary outcomes were the change from baseline to 6 mo in the International Prostate Symptom Score (IPSS) and the quality of life (QoL) score at 6 mo, analysed with analysis of covariance and t test, respectively.
RESULTS AND LIMITATIONS


Mean age was 63.8±6.0yr, baseline IPSS 26.4±3.87, and QoL score 4.43±0.52. At 6 mo, patients in the PAE arm had a greater improvement in IPSS, with a difference in the change from baseline of 13.2 (95% confidence interval [CI] 10.2-16.2, p<0.0001), and a better QoL score at 6 mo (difference: 2.13; 95% CI 1.57-2.68, p<0.0001) than the patients in the sham arm. The improvements in IPSS and QoL in the sham group 6 mo after they performed PAE were, respectively, 13.6±9.19 (p<0.0001) and 2.05 ± 1.71 (p<0.0001). Adverse events occurred in 14 (35.0%) patients after PAE and in 13 (32.5%) after sham, with one serious adverse event in the sham group during the open period. No treatment failures occurred. Limitations include a single-centre trial, only severe LUTS/BPH, and follow-up limited to 12 mo.
CONCLUSIONS


The improvements in subjective and objective variables after PAE are far superior from those due to the placebo effect.
PATIENT SUMMARY


Clearly superior efficacy of prostatic artery embolisation (PAE) compared with a sham procedure was found in this study, which supports the use of PAE in patients with typical symptoms associated with benign prostatic hyperplasia.",2020,"Clearly superior efficacy of prostatic artery embolisation (PAE) compared with a sham procedure was found in this study, which supports the use of PAE in patients with typical symptoms associated with benign prostatic hyperplasia.","['Benign Prostatic Hyperplasia', '80 males ≥45yr with severe LUTS/BPH refractory to medical treatment from 2014 to 2019 in a private clinic, with efficacy assessments at 6 and 12 mo after randomisation', 'patients with typical symptoms associated with benign prostatic hyperplasia']","['Prostatic artery embolisation (PAE', 'Prostatic Artery Embolisation Versus a Sham Procedure', 'prostatic artery embolisation (PAE', 'PAE', 'successful catheterisation of a prostatic artery to either PAE or a sham PAE procedure without embolisation']","['IPSS', 'safety and efficacy', 'IPSS and QoL', 'Adverse events', 'QoL score', 'International Prostate Symptom Score (IPSS) and the quality of life (QoL) score']","[{'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0034380'}]",,0.429283,"Clearly superior efficacy of prostatic artery embolisation (PAE) compared with a sham procedure was found in this study, which supports the use of PAE in patients with typical symptoms associated with benign prostatic hyperplasia.","[{'ForeName': 'João Martins', 'Initials': 'JM', 'LastName': 'Pisco', 'Affiliation': 'Interventional Radiology Unit, Hôpital Saint-Louis, Lisbon, Portugal.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Bilhim', 'Affiliation': 'Interventional Radiology Unit, Hôpital Saint-Louis, Lisbon, Portugal; Curry Cabral Hospital, Centro Hospitalar Universitário de Lisboa Central (CHULC), Lisbon, Portugal; Radiology Department, NOVA Medical School, Lisbon, Portugal.'}, {'ForeName': 'Nuno V', 'Initials': 'NV', 'LastName': 'Costa', 'Affiliation': 'Interventional Radiology Unit, Hôpital Saint-Louis, Lisbon, Portugal; Curry Cabral Hospital, Centro Hospitalar Universitário de Lisboa Central (CHULC), Lisbon, Portugal; Radiology Department, NOVA Medical School, Lisbon, Portugal.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Torres', 'Affiliation': 'Interventional Radiology Unit, Hôpital Saint-Louis, Lisbon, Portugal; Curry Cabral Hospital, Centro Hospitalar Universitário de Lisboa Central (CHULC), Lisbon, Portugal; Radiology Department, NOVA Medical School, Lisbon, Portugal.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Pisco', 'Affiliation': 'Interventional Radiology Unit, Hôpital Saint-Louis, Lisbon, Portugal.'}, {'ForeName': 'Luis Campos', 'Initials': 'LC', 'LastName': 'Pinheiro', 'Affiliation': 'Radiology Department, NOVA Medical School, Lisbon, Portugal; Urology Department, Centro Hospitalar Universitário de Lisboa Central (CHULC), Lisbon, Portugal.'}, {'ForeName': 'Antonio Gouveia', 'Initials': 'AG', 'LastName': 'Oliveira', 'Affiliation': 'Department of Pharmacy, Centro de Ciências da Saúde, Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN, Brazil. Electronic address: oliveira.amg@gmail.com.'}]",European urology,['10.1016/j.eururo.2019.11.010']
3007,32074597,Patient-Centered Placement Matching of Alcohol-Dependent Patients Based on a Standardized Intake Assessment: Primary Outcomes of an Exploratory Randomized Controlled Trial.,"BACKGROUND


Placement matching guidelines are promising means to optimize patient-centered care and to match patients' treatment needs. Despite considerable research regarding placement matching approaches to optimize alcohol abuse treatment, findings are inconclusive.
OBJECTIVES


To investigate whether the use of patient-centered placement matching (PCPM) guidelines is more effective in reducing heavy drinking and costs 6 months after discharge from an inpatient alcohol withdrawal treatment compared to usual referral to aftercare. Secondary aims were to investigate whether age, gender, trial site or level of care (LOC) are moderators of efficacy and whether patients who were actually referred to the recommended LOC had better treatment outcomes compared to patients who were treated under- or overmatched.
METHODS


Design. Exploratory randomized controlled trial with measurements during withdrawal treatment and 6 months after initial assessment.
SETTING


Four German psychiatric clinics offering a 7-21 day inpatient qualified withdrawal program for patients suffering from alcohol dependence.
PARTICIPANTS


From 1,927 patients who had a primary diagnosis of alcohol dependence and did not have organized aftercare when entering withdrawal treatment, 299 were invited to participate. Of those, 250 were randomized to the intervention group (IG, n = 123) or the control group (CG, n = 127).
INTERVENTION


The PCPM were applied to patients of the IG by feeding back a recommendation to a LOC for aftercare that was calculated from the Measurements in the Addictions for Triage and Evaluation (MATE) and discussed with the staff of the treatment unit. Patients of the CG received a general feedback regarding their MATE interview on request.
MEASUREMENTS


The MATE, the Client Socio-Demographic and Service Receipt Inventory--European Version and the MATE-Outcomes were administered. Data were analyzed using generalized linear models.
RESULTS


In the intention-to-treat analysis, there were no significant differences between IG and CG regarding days of heavy drinking (incident risk ratio [IRR] 1.09; p = 0.640), direct (IRR 1.06; p = 0.779), indirect (IRR 0.77; p = 0.392) and total costs (IRR 0.89; p = 0.496). Furthermore, none of the investigated moderator variables affected statistically significant drinking or cost-related primary outcomes. Regardless of group allocation, patients who received matched aftercare reported significantly fewer days of heavy drinking than undermatched patients (IRR 2.09; p = 0.004). For patients who were overmatched, direct costs were significantly higher (IRR 1.79; p = 0.024), but with no additional effects on alcohol consumption compared to matched patients.
CONCLUSIONS


While the use of PCPM failed to affect the actual referral to aftercare, our findings suggest that treating patients on the recommended LOC may have the potential to reduce days of heavy drinking compared to undertreatment and costs compared to overtreatment.",2020,"For patients who were overmatched, direct costs were significantly higher (IRR 1.79; p = 0.024), but with no additional effects on alcohol consumption compared to matched patients.
","['Four German psychiatric clinics offering a 7-21 day inpatient qualified withdrawal program for patients suffering from alcohol dependence', 'From 1,927 patients who had a primary diagnosis of alcohol dependence and did not have organized aftercare when entering withdrawal treatment, 299 were invited to participate']","['PCPM', 'patient-centered placement matching (PCPM) guidelines', 'Standardized Intake Assessment']","['total costs', 'days of heavy drinking', 'direct costs', 'alcohol consumption', 'actual referral to aftercare']","[{'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0084094', 'cui_str': 'Poly(oxymethyleneoxy-1,4-phenylenecarbonyloxycarbonyl-1,4-phenylene)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]",1927.0,0.0866111,"For patients who were overmatched, direct costs were significantly higher (IRR 1.79; p = 0.024), but with no additional effects on alcohol consumption compared to matched patients.
","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Buchholz', 'Affiliation': 'Department of Medical Psychology, Centre for Psychosocial Medicine, University Medical Centre, Hamburg, Germany, a.buchholz@uke.de.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Dams', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Rosahl', 'Affiliation': 'Department of Medical Psychology, Centre for Psychosocial Medicine, University Medical Centre, Hamburg, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Hempleman', 'Affiliation': 'LWL-Hospital Muenster, Outpatient Department for Addiction, Münster, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Konnopka', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kraus', 'Affiliation': 'IFT Institut für Therapieforschung, Munich, Germany.'}, {'ForeName': 'Levente', 'Initials': 'L', 'LastName': 'Kriston', 'Affiliation': 'Department of Medical Psychology, Centre for Psychosocial Medicine, University Medical Centre, Hamburg, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Piontek', 'Affiliation': 'IFT Institut für Therapieforschung, Munich, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Reimer', 'Affiliation': 'Centre for Interdisciplinary Addiction Research, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Röhrig', 'Affiliation': 'Department for Clinical Psychology, Municipal Clinical Center of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Scherbaum', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, LVR-Hospital Essen, Medical Faculty, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Silkens', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, LVR-Hospital Essen, Medical Faculty, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berner', 'Affiliation': 'Municipal Clinical Center of Karlsruhe, Karlsruhe, Germany.'}]",European addiction research,['10.1159/000505913']
3008,31707832,Patients With High Genome-Wide Polygenic Risk Scores for Coronary Artery Disease May Receive Greater Clinical Benefit From Alirocumab Treatment in the ODYSSEY OUTCOMES Trial.,"BACKGROUND


Alirocumab, an antibody that blocks PCSK9 (proprotein convertase subtilisin/kexin type 9), was associated with reduced major adverse cardiovascular events (MACE) and death in the ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab). In this study, higher baseline levels of low-density lipoprotein cholesterol (LDL-C) predicted greater benefit from alirocumab treatment. Recent studies indicate high polygenic risk scores (PRS) for coronary artery disease (CAD) identify individuals at higher risk who derive increased benefit from statins. We performed post hoc analyses to determine whether high PRS for CAD identifies higher-risk individuals, independent of baseline LDL-C and other known risk factors, who might derive greater benefit from alirocumab treatment.
METHODS


ODYSSEY OUTCOMES was a randomized, double-blind, placebo-controlled trial comparing alirocumab or placebo in 18 924 patients with acute coronary syndrome and elevated atherogenic lipoproteins despite optimized statin treatment. The primary endpoint (MACE) comprised death of CAD, nonfatal myocardial infarction, ischemic stroke, or unstable angina requiring hospitalization. A genome-wide PRS for CAD comprising 6 579 025 genetic variants was evaluated in 11 953 patients with available DNA samples. Analysis of MACE risk was performed in placebo-treated patients, whereas treatment benefit analysis was performed in all patients.
RESULTS


The incidence of MACE in the placebo group was related to PRS for CAD: 17.0% for high PRS patients (>90th percentile) and 11.4% for lower PRS patients (≤90th percentile;  P <0.001); this PRS relationship was not explained by baseline LDL-C or other established risk factors. Both the absolute and relative reduction of MACE by alirocumab compared with placebo was greater in high versus low PRS patients. There was an absolute reduction by alirocumab in high versus low PRS groups of 6.0% and 1.5%, respectively, and a relative risk reduction by alirocumab of 37% in the high PRS group (hazard ratio, 0.63 [95% CI, 0.46-0.86];  P =0.004) versus a 13% reduction in the low PRS group (hazard ratio, 0.87 [95% CI, 0.78-0.98];  P =0.022; interaction  P =0.04).
CONCLUSIONS


A high PRS for CAD is associated with elevated risk for recurrent MACE after acute coronary syndrome and a larger absolute and relative risk reduction with alirocumab treatment, providing an independent tool for risk stratification and precision medicine.",2020,Both the absolute and relative reduction of MACE by alirocumab compared to placebo was greater in high versus low PRS patients.,"['Patients with High Genome-Wide Polygenic Risk Scores for Coronary Artery Disease', '11,953 patients with available DNA samples', '18,924 patients with acute coronary syndrome and elevated atherogenic lipoproteins despite optimized statin treatment']","['placebo', 'alirocumab or placebo']","['higher baseline LDL cholesterol (LDL-C) levels', 'incidence of MACE', 'death from CAD, nonfatal myocardial infarction, ischemic stroke, or unstable angina requiring hospitalization', 'absolute reduction by alirocumab']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}]",,0.446012,Both the absolute and relative reduction of MACE by alirocumab compared to placebo was greater in high versus low PRS patients.,"[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Damask', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (A.D., P.B., G.M., R.P., J.D.O., L.A.L., G.D.Y., G.R.A., A.B., C.P.).'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, INSERM U1148, France (P.G.S.).'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'University of Colorado School of Medicine, Aurora (G.G.S.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'Department of Biostatistics and Epidemiology, SUNY Downstate School of Public Health, Brooklyn, NY (M.S.).'}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Hagström', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Sweden (E.H.).'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Badimon', 'Affiliation': 'Cardiovascular Program-ICCC, CiberCV, IR-Hospital de la Santa Creu i Sant Pau, Barcelona, Spain (L.B.).'}, {'ForeName': 'M John', 'Initials': 'MJ', 'LastName': 'Chapman', 'Affiliation': 'Endocrinology Metabolism Division, Pitie-Salpetriere University Hospital, Sorbonne University and National Institute for Health and Medical Research (INSERM), Paris, France (M.J.C.).'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Boileau', 'Affiliation': 'Université de Paris, INSERM U1148 and Genetics Department, APHP-Hospital Bichat-Claude Bernard, France (C.B.).'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsimikas', 'Affiliation': 'Sulpizio Cardiovascular Center, Division of Cardiovascular Medicine, University of California San Diego, La Jolla (S.T.).'}, {'ForeName': 'Henry N', 'Initials': 'HN', 'LastName': 'Ginsberg', 'Affiliation': 'Irving Institute for Clinical and Translational Research, Columbia University, New York (H.N.G.).'}, {'ForeName': 'Poulabi', 'Initials': 'P', 'LastName': 'Banerjee', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (A.D., P.B., G.M., R.P., J.D.O., L.A.L., G.D.Y., G.R.A., A.B., C.P.).'}, {'ForeName': 'Garen', 'Initials': 'G', 'LastName': 'Manvelian', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (A.D., P.B., G.M., R.P., J.D.O., L.A.L., G.D.Y., G.R.A., A.B., C.P.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (A.D., P.B., G.M., R.P., J.D.O., L.A.L., G.D.Y., G.R.A., A.B., C.P.).'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Hess', 'Affiliation': 'Sanofi Aventis Deutschland GmbH, Translational Medicine and Early Development, Biomarkers and Clinical Bioanalyses, Frankfurt, Germany (S.H.).'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Overton', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (A.D., P.B., G.M., R.P., J.D.O., L.A.L., G.D.Y., G.R.A., A.B., C.P.).'}, {'ForeName': 'Luca A', 'Initials': 'LA', 'LastName': 'Lotta', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (A.D., P.B., G.M., R.P., J.D.O., L.A.L., G.D.Y., G.R.A., A.B., C.P.).'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (A.D., P.B., G.M., R.P., J.D.O., L.A.L., G.D.Y., G.R.A., A.B., C.P.).'}, {'ForeName': 'Goncalo R', 'Initials': 'GR', 'LastName': 'Abecasis', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (A.D., P.B., G.M., R.P., J.D.O., L.A.L., G.D.Y., G.R.A., A.B., C.P.).'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Baras', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (A.D., P.B., G.M., R.P., J.D.O., L.A.L., G.D.Y., G.R.A., A.B., C.P.).'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Paulding', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (A.D., P.B., G.M., R.P., J.D.O., L.A.L., G.D.Y., G.R.A., A.B., C.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.044434']
3009,32024411,Cross-training effect of chronic whole-body vibration exercise: a randomized controlled study.,"Purpose:  To determine whether unilateral leg whole-body vibration (WBV) strength training induces strength gain in the untrained contralateral leg muscle. The secondary aim was to determine the potential role of spinal neurological mechanisms regarding the effect of WBV exercise on contralateral strength training. Materials and Methods:  Forty-two young adult healthy volunteers were randomized into two groups: WBV exercise and Sham control. An isometric semi-squat exercise during WBV was applied regularly through 20 sessions. WBV training was applied to the right leg in the WBV group and the left leg was isolated from vibration. Sham WBV was applied to the right leg of participants in the Control group. Pre- and post-training isokinetic torque and reflex latency of both quadricepses were evaluated. Results:  The increase in the strength of right (vibrated) knee extensors was 9.4 ± 10.7% in the WBV group ( p  = .001) and was 1.2 ± 6.6% in the Control group ( p  = .724). The left (non-vibrated) extensorsvibrated) knee extensors w4 ± 8.4% in the WBV group ( p  = .038), whereas it decreased by 1.4 ± 7.0% in the Control ( p  = .294). The strength gains were significant between the two groups. WBV induced the reflex response of the quadriceps muscle in the vibrated ipsilateral leg and also in the non-vibrated contralateral leg, though with a definite delay. The WBV-induced muscle reflex (WBV-IMR) latency was 22.5 ± 7.7 ms for the vibrated leg and 39.3 ± 14.6 ms for the non-vibrated leg. Conclusions:  Chronic WBV training has an effect of the cross-transfer of strength to contralateral homologous muscles. The WBV-induced muscular reflex may have a role in the mechanism of cross-transfer strength.",2020,The increase in the strength of right (vibrated) knee extensors was 9.4 ± 10.7% in the WBV group ( p  = .001) and was 1.2 ± 6.6% in the Control group ( p  = .724).,"['Forty-two young adult healthy volunteers', 'untrained contralateral leg muscle']","['WBV exercise and Sham control', 'WBV training', 'chronic whole-body vibration exercise', 'Chronic WBV training', 'unilateral leg whole-body vibration (WBV) strength training', 'Sham WBV', 'WBV exercise']","['reflex response', 'strength gains', 'strength gain', 'strength of right (vibrated) knee extensors', 'WBV-induced muscle reflex (WBV-IMR) latency']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C4281598', 'cui_str': 'Right knee'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]",42.0,0.0118868,The increase in the strength of right (vibrated) knee extensors was 9.4 ± 10.7% in the WBV group ( p  = .001) and was 1.2 ± 6.6% in the Control group ( p  = .724).,"[{'ForeName': 'Tuğba', 'Initials': 'T', 'LastName': 'Aydın', 'Affiliation': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Fatma Nur', 'Initials': 'FN', 'LastName': 'Kesiktaş', 'Affiliation': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Akın', 'Initials': 'A', 'LastName': 'Baskent', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Medical Faculty, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Ayşe', 'Initials': 'A', 'LastName': 'Karan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Medical Faculty, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Ilhan', 'Initials': 'I', 'LastName': 'Karacan', 'Affiliation': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Kemal S', 'Initials': 'KS', 'LastName': 'Türker', 'Affiliation': 'Physiology Department, Koc University School of Medicine, Istanbul, Turkey.'}]",Somatosensory & motor research,['10.1080/08990220.2020.1720635']
3010,32053534,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Austin Y', 'Initials': 'AY', 'LastName': 'Ha', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Guffey', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006783']
3011,32034285,Response-adapted lenalidomide maintenance in newly diagnosed myeloma: results from the phase III GMMG-MM5 trial.,"The MM5 trial aimed at demonstrating a progression-free survival (PFS) difference in continued vs. response-adapted (in case of complete response, CR) lenalidomide (LEN) maintenance therapy (MT) in newly diagnosed, transplant-eligible multiple myeloma (MM). Patients were equally randomized to receive induction therapy with PAd (bortezomib/doxorubicin/dexamethasone) or VCD (bortezomib/cyclophosphamide/dexamethasone), high-dose melphalan and autologous blood stem cell transplantation, and LEN consolidation, followed by either LEN MT for a fixed duration of 2 years (LEN-2Y) or until achievement of CR (LEN-CR, intention-to-treat population n = 502): arms A1:PAd + LEN-2Y (n = 125), B1:PAd + LEN-CR (n = 126), A2:VCD + LEN-2Y (n = 126), B2:VCD + LEN-CR (n = 125). In the LEN-CR group (B1 + B2), n = 88/17.5% patients did not start or discontinued LEN MT due to CR. There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms. On pooled LEN MT strategies, OS (hazard ratio, hazard ratio [HR] = 1.42, p = 0.03) but not PFS (HR = 1.15, p = 0.20) was shorter in LEN-CR (B1 + B2) vs. LEN-2Y (A1 + A2) groups. PFS was shortened on landmark analyses from the start of LEN MT in patients being in CR in the LEN-CR group (LEN-CR vs. LEN-2Y, HR = 1.84, p = 0.02). OS from first progression was shortened in the LEN-CR vs. LEN-2Y group (HR = 1.60, p = 0.01). LEN MT should be applied beyond CR for at least 2 years.",2020,"There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms.","['newly diagnosed myeloma', 'newly diagnosed, transplant-eligible multiple myeloma (MM']","['Response-adapted lenalidomide maintenance', 'CR) lenalidomide (LEN) maintenance therapy (MT', 'induction therapy with PAd (bortezomib/doxorubicin/dexamethasone) or VCD (bortezomib/cyclophosphamide/dexamethasone), high-dose melphalan and autologous blood stem cell transplantation, and LEN consolidation, followed by either LEN MT for a fixed duration of 2 years (LEN-2Y) or until achievement of CR (LEN-CR, intention-to-treat population n\u2009=\u2009502): arms A1:PAd\u2009+\u2009LEN-2Y (n\u2009=\u2009125), B1:PAd\u2009+\u2009LEN-CR (n\u2009=\u2009126), A2:VCD\u2009+\u2009LEN-2Y (n\u2009=\u2009126), B2:VCD\u2009+\u2009LEN-CR']","['PFS', 'overall survival (OS']","[{'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0511233,"There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms.","[{'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany. hartmut.goldschmidt@med.uni-heidelberg.de.'}, {'ForeName': 'Elias K', 'Initials': 'EK', 'LastName': 'Mai', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Dürig', 'Affiliation': 'Department of Hematology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Scheid', 'Affiliation': 'Department of Internal Medicine I, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Katja C', 'Initials': 'KC', 'LastName': 'Weisel', 'Affiliation': 'Department of Hematology, Oncology and Immunology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kunz', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Bertsch', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hielscher', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Merz', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Munder', 'Affiliation': 'Department of Internal Medicine III, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Hans-Walter', 'Initials': 'HW', 'LastName': 'Lindemann', 'Affiliation': 'Department of Hematology and Oncology, Katholisches Krankenhaus Hagen, Hagen, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hügle-Dörr', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Tichy', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Giesen', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Hose', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Seckinger', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Huhn', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Luntz', 'Affiliation': 'Coordination Centre for Clinical Trials (KKS), Heidelberg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jauch', 'Affiliation': 'Institute of Human Genetics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Elmaagacli', 'Affiliation': 'Department of Hematology and Oncology, Asklepios Hospital Hamburg St. Georg, Hamburg, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Rabold', 'Affiliation': 'Coordination Centre for Clinical Trials (KKS), Heidelberg, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Fuhrmann', 'Affiliation': 'Department of Hematology and Oncology, Helios Hospital Berlin Buch, Berlin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brossart', 'Affiliation': 'University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Goerner', 'Affiliation': 'Department of Hematology, Oncology and Palliative Care, Klinikum Bielefeld, Bielefeld, Germany.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Bernhard', 'Affiliation': 'Internal Medicine V, Klinikum Darmstadt, Darmstadt, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hoffmann', 'Affiliation': 'Medical Clinic A, Klinikum Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Hillengass', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Raab', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Igor W', 'Initials': 'IW', 'LastName': 'Blau', 'Affiliation': 'Medical Clinic, Charité University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Hänel', 'Affiliation': 'Department of Internal Medicine III, Klinikum Chemnitz, Chemnitz, Germany.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Salwender', 'Affiliation': 'Department of Hematology and Oncology, Asklepios Hospital Hamburg Altona, Hamburg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-020-0724-1']
3012,32053538,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Knackstedt', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gatherwright', 'Affiliation': ''}, {'ForeName': 'Risal', 'Initials': 'R', 'LastName': 'Djohan', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006782']
3013,32026844,Comparison of virtual reality rehabilitation and conventional rehabilitation in Parkinson's disease: a randomised controlled trial.,"OBJECTIVE


To compare a 6-week virtual reality (VR) rehabilitation programme with a conventional rehabilitation programme in patients with Parkinson's disease.
DESIGN


Prospective, single-blinded, randomised controlled trial.
SETTING


Outpatients.
PARTICIPANTS


Fifty-one patients with Parkinson's disease were assigned at random to a VR rehabilitation programme or a conventional rehabilitation programme.
INTERVENTIONS


Both programmes ran for 6 consecutive weeks, with a 40-minute session three times per week.
MAIN OUTCOME MEASURES


The Balance Berg Scale (BBS) was used to measure balance. Secondary outcome measures were: Dynamic Gait Index (DGI) to evaluate ability to adapt gait to complex walking tasks; Disabilities of the Arm, Shoulder and Hand (DASH) scale to measure performance of the upper limb; and Short Form 36 (SF-36) to evaluate quality of life.
RESULTS


The VR rehabilitation programme led to an increase in BBS score {45.6 [standard deviation (SD) 7.9] vs 49.2 (SD 8.1), mean difference 3.6, 95% confidence interval (CI) 1.3 to 5.9; P=0.003}, DGI score [18.7 (SD 4.7) vs 20.2 (SD 4.2), mean difference 1.6, 95% CI 0.6 to 2.5; P=0.003] and SF-36 mental composite score [37.7 (SD 11.4) vs 43.5 (SD 9.2), mean difference 5.8, 95% CI 0.4 to 11.3; P=0.037], and a decrease in DASH scale score [29.6 (SD 17.5) vs 21.6 (SD 15.1), mean difference -7.9, 95% CI -13.7 to -2.2; P=0.009]. In contrast, the conventional rehabilitation programme only led to a decrease in DASH scale score [30.3 (SD 18.1) vs 25.1 (SD 15.8), mean difference -5.2, 95% CI -8.8 to -1.5; P=0.007].
CONCLUSION


These findings suggest that rehabilitation is useful in Parkinson's disease, and the VR rehabilitation programme was more effective in determining overall improvement than the conventional rehabilitation programme.
CLINICAL TRIAL REGISTRATION NUMBER


NCT02807740.",2020,"PARTICIPANTS


Fifty-one patients with Parkinson's disease were assigned at random to a VR rehabilitation programme or a conventional rehabilitation programme.
","[""Parkinson's disease"", 'Outpatients', ""patients with Parkinson's disease"", ""Fifty-one patients with Parkinson's disease""]","['conventional rehabilitation programme', 'virtual reality rehabilitation and conventional rehabilitation', 'VR rehabilitation programme or a conventional rehabilitation programme', 'virtual reality (VR) rehabilitation programme']","['Balance Berg Scale (BBS', 'DGI score', 'DASH scale score', 'Dynamic Gait Index (DGI) to evaluate ability to adapt gait to complex walking tasks; Disabilities of the Arm, Shoulder and Hand (DASH) scale to measure performance of the upper limb; and Short Form 36 (SF-36) to evaluate quality of life', 'BBS score', 'SF-36 mental composite score']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2919794', 'cui_str': 'Dynamic gait index (assessment scale)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034380'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",51.0,0.159318,"PARTICIPANTS


Fifty-one patients with Parkinson's disease were assigned at random to a VR rehabilitation programme or a conventional rehabilitation programme.
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pazzaglia', 'Affiliation': 'Department of Neurorehabilitation, IRCCS Don Carlo Gnocchi, Milan, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Imbimbo', 'Affiliation': 'Department of Neurorehabilitation, IRCCS Don Carlo Gnocchi, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Tranchita', 'Affiliation': 'Department of Movement, Human and Health Sciences, Division of Health Sciences, University of Rome Foro Italico, Rome, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Minganti', 'Affiliation': 'Department of Movement, Human and Health Sciences, Division of Health Sciences, University of Rome Foro Italico, Rome, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ricciardi', 'Affiliation': 'Department of Geriatrics, Neurosciences and Orthopaedics, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lo Monaco', 'Affiliation': 'Department of Geriatrics, Neurosciences and Orthopaedics, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Parisi', 'Affiliation': 'Department of Movement, Human and Health Sciences, Division of Health Sciences, University of Rome Foro Italico, Rome, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Padua', 'Affiliation': 'Department of Geriatrics, Neurosciences and Orthopaedics, Università Cattolica del Sacro Cuore, Rome, Italy; UO Neuroriabilitazione ad Alta Intensità, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. Electronic address: luca.padua@unicatt.it.'}]",Physiotherapy,['10.1016/j.physio.2019.12.007']
3014,32026846,Development of a functional rehabilitation intervention for post knee arthroplasty patients: COmmunity based Rehabilitation post Knee Arthroplasty (CORKA) trial.,"Knee osteoarthritis is a common cause of disability in older people and knee arthroplasty surgery in the UK is increasing. The CORKA trial is a randomised controlled trial of rehabilitation targeted at patients identified as being at risk of a poor outcome after knee arthroplasty. This paper describes the development and delivery of the CORKA intervention. It was informed by current evidence, relevant guidelines, expert and patient opinion, practical considerations and a pilot study. The intervention is a multicomponent rehabilitation programme with the main component being an exercise programme delivered to participants in their own home. It includes functional task practice, strategies to improve adherence and where appropriate the provision of appropriate aids and equipment.",2020,The CORKA trial is a randomised controlled trial of rehabilitation targeted at patients identified as being at risk of a poor outcome after knee arthroplasty.,"['patients identified as being at risk of a poor outcome after knee arthroplasty', 'post knee arthroplasty patients']","['functional rehabilitation intervention', 'multicomponent rehabilitation programme with the main component being an exercise programme delivered to participants in their own home']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0454532', 'cui_str': 'Functional rehabilitation (regime/therapy)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]",[],,0.0682497,The CORKA trial is a randomised controlled trial of rehabilitation targeted at patients identified as being at risk of a poor outcome after knee arthroplasty.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Room', 'Affiliation': 'Physiotherapy Research Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS FT, Oxford, United Kingdom; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom. Electronic address: jonathan.room@ouh.nhs.uk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Batting', 'Affiliation': 'Physiotherapy Research Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS FT, Oxford, United Kingdom.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Barker', 'Affiliation': 'Physiotherapy Research Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS FT, Oxford, United Kingdom; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}]",Physiotherapy,['10.1016/j.physio.2019.06.004']
3015,31981604,"Comparing the efficacies of two chemo-mechanical caries removal agents (2.25% sodium hypochlorite gel and brix 3000), in caries removal and patient cooperation: A randomized controlled clinical trial.","INTRODUCTION


This study compared and evaluated the effectiveness of Brix 3000 and 2.25 % sodium hypochlorite (NaOCl) gel with conventional rotary instrumentation method in caries excavation of primary molars. The null hypothesis: no difference between the two tested chemo-mechanical caries removal (CMCR) agents used in this trial.
MATERIALS AND METHODS


a randomized controlled clinical trial conducted with 32 children suffering from proximal caries of primary maxillary molars, age ranging between 6 and 9 years old. Subjects were randomly assigned into three groups: Brix 3000, NaOCl gel, and conventional with 10, 12, and 10 teeth in each group, respectively. After isolation of selected teeth, either CMCR agent were applied for two minutes. The application was repeated as needed until a caries-free surface was obtained. The conventional group used low-speed burs to excavate all carious lesions. The time required to obtain a caries-free result for each testing method was recorded. Wong-Baker FACES pain rating scale was used to assess the acceptance of the technique used by the child.
RESULTS


Conventional treatment required significantly less time for caries removal compared to Brix 3000 (P = .002) and NaOCl gel (P = .000). No significant difference observed between Brix 3000 and NaOCl gel (P = .679). Statistically higher pain scores were observed with conventional treatment compared to both Brix 3000 (P = .000) and NaOCl gel (P = .005). Pain scores were lower with Brix 3000, and NaOCl gel with no significant difference observed between the CMCR agents (p = .690).
CONCLUSIONS


CMCR agents that are effective in removing the carious dentine of primary teeth without negatively affecting the cooperation of children.
CLINICAL SIGNIFICANCE


The use of a 2.25 % sodium hypochlorite gel can be an effective and well-tolerated method of removing decay from primary teeth and reduce the trauma associated with conventional rotary caries removal.",2020,"Pain scores were lower with Brix 3000, and NaOCl gel with no significant difference observed between the CMCR agents (p = .690).
","['caries excavation of primary molars', '32 children suffering from proximal caries of primary maxillary molars, age ranging between 6 and 9 years old']","['Chemo-mechanical caries removal agents (2.25% sodium hypochlorite gel and Brix 3000', 'Brix 3000 and 2.25% sodium hypochlorite (NaOCl) gel with conventional rotary instrumentation method', 'chemo-mechanical caries removal (CMCR) agents', 'sodium hypochlorite gel']","['NaOCl gel', 'Pain scores', 'Wong-Baker FACES pain rating scale', 'time for caries removal', 'pain scores']","[{'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C4068875', 'cui_str': '2.25 (qualifier value)'}, {'cui': 'C0037518', 'cui_str': 'Sodium Hypochlorite'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0015468', 'cui_str': 'Face Pain'}, {'cui': 'C0222045'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]",32.0,0.0267687,"Pain scores were lower with Brix 3000, and NaOCl gel with no significant difference observed between the CMCR agents (p = .690).
","[{'ForeName': 'Muaaz M', 'Initials': 'MM', 'LastName': 'Alkhouli', 'Affiliation': 'Faculty of Dentistry, Damascus University, Damascus, Syria.'}, {'ForeName': 'Salma F', 'Initials': 'SF', 'LastName': 'Al Nesser', 'Affiliation': 'Faculty of Dentistry, Damascus University, Damascus, Syria.'}, {'ForeName': 'Nada G', 'Initials': 'NG', 'LastName': 'Bshara', 'Affiliation': 'Faculty of Dentistry, Damascus University, Damascus, Syria.'}, {'ForeName': 'Awab N', 'Initials': 'AN', 'LastName': 'AlMidani', 'Affiliation': 'Faculty of Dentistry, Damascus University, Damascus, Syria.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Comisi', 'Affiliation': 'Department of Oral Rehabilitation. Medical University of South Carolina, James B. Edwards College of Dental Medicine, Charleston, SC USA. Electronic address: comisi@musc.edu.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103280']
3016,32039987,Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study - A Randomized Clinical Trial.,"MINI: In this randomized clinical trial to prevent anastomotic recurrence in Crohn disease, the new Kono-S anastomosis demonstrates a significant reduction in postoperative clinical and endoscopic recurrence rates after ileocolic surgery than conventional side-to-side anastomosis and no safety issues.
OBJECTIVE


This trial aimed to provide randomized controlled data comparing Kono-S anastomosis and stapled ileocolic side-to-side anastomosis.
BACKGROUND


Recently, a new antimesenteric, functional, end-to-end, hand-sewn ileocolic anastomosis (Kono-S) has shown a significant reduction in endoscopic recurrence score and surgical recurrence rate in Crohn disease (CD).
METHODS


Randomized controlled trial (RCT) at a tertiary referral institution. Primary endpoint: endoscopic recurrence (ER) (Rutgeerts score ≥i2) after 6 months. Secondary endpoints: clinical recurrence (CR) after 12 and 24 months, ER after 18 months, and surgical recurrence (SR) after 24 months.
RESULTS


In all, 79 ileocolic CD patients were randomized in Kono group (36) and Conventional group (43). After 6 months, 22.2% in the Kono group and 62.8% in the Conventional group presented an ER [P < 0.001, odds ratio (OR) 5.91]. A severe postoperative ER (Rutgeerts score ≥i3) was found in 13.8% of Kono versus 34.8% of Conventional group patients (P = 0.03, OR 3.32). CR rate was 8% in the Kono group versus 18% in the Conventional group after 12 months (P = 0.2), and 18% versus 30.2% after 24 months (P = 0.04, OR 3.47). SR rate after 24 months was 0% in the Kono group versus 4.6% in the Conventional group (P = 0.3). Patients with Kono-S anastomosis presented a longer time until CR than patients with side-to-side anastomosis (hazard ratio 0.36, P = 0.037). On binary logistic regression analysis, the Kono-S anastomosis was the only variable significantly associated with a reduced risk of ER (OR 0.19, P < 0.001). There were no differences in postoperative outcomes.
CONCLUSIONS


This is the first RCT comparing Kono-S anastomosis and standard anastomosis in CD. The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.ClinicalTrials.gov ID NCT02631967.",2020,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[""Crohn's Disease"", '79 ileocolic CD patients']","['Kono-S anastomosis and stapled ileocolic side-to-side anastomosis', 'MINI']","['SR rate', 'longer time until CR', 'postoperative outcomes', 'postoperative endoscopic and clinical recurrence rate', 'CR rate', 'endoscopic recurrence (ER) ', 'postoperative clinical and endoscopic recurrence rates', 'severe postoperative ER', 'endoscopic recurrence score and surgical recurrence rate', 'clinical recurrence (CR', 'reduced risk of ER', 'surgical recurrence (SR']","[{'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic (qualifier value)'}, {'cui': 'C0677619', 'cui_str': 'Side-to-side anastomosis (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",79.0,0.165843,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Luglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rispo', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Imperatore', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Mariano Cesare', 'Initials': 'MC', 'LastName': 'Giglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Amendola', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Francesca Paola', 'Initials': 'FP', 'LastName': 'Tropeano', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Peltrini', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Castiglione', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Giovanni Domenico', 'Initials': 'GD', 'LastName': 'De Palma', 'Affiliation': 'Surgical Endoscopy, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Bucci', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}]",Annals of surgery,['10.1097/SLA.0000000000003821']
3017,32029248,Complete 2-Year Results Confirm Bayesian Analysis of the SURTAVI Trial.,"OBJECTIVES


The aim of this study was to report the 2-year results of the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial and confirm the interim Bayesian analysis.
BACKGROUND


Transcatheter aortic valve replacement (TAVR) with a self-expanding valve was noninferior to surgery in patients with severe aortic stenosis and intermediate operative risk using Bayesian statistical methods. Novel Bayesian designs have been used to shorten the time to primary endpoint analysis in randomized clinical trials, although the predictive value of Bayesian analysis compared with frequentist approaches remains debated.
METHODS


The SURTAVI trial randomized 1,660 patients. An interim analysis was performed 1 year after the 1,400th patient was treated to estimate the primary 2-year endpoint of all-cause mortality or disabling strokes for all patients.
RESULTS


The Kaplan-Meier rate for the complete 2-year primary endpoint was 12.7% in the TAVR group and 12.6% in the surgery group (0.0% difference; 95% confidence interval: -3.4% to 3.5%), compared with 12.6% with TAVR and 14.0% with surgery (-1.4% difference; Bayesian credible interval: -5.2% to 2.3%) in the interim Bayesian analysis. A comparison of individual clinical, hemodynamic, and quality-of-life endpoints using Bayesian and frequentist methods found no significant differences.
CONCLUSIONS


The complete analysis of all patients with aortic stenosis at intermediate risk for surgery in the SURTAVI trial confirmed the noninferiority, with respect to the frequency of all-cause mortality or disabling stroke, of TAVR to surgery, as determined in the interim Bayesian analysis. Follow-up will extend out to 10 years.",2020,"The Kaplan-Meier rate for the complete 2-year primary endpoint was 12.7% in the TAVR group and 12.6% in the surgery group (0.0% difference; 95% confidence interval: -3.4% to 3.5%), compared with 12.6% with TAVR and 14.0% with surgery (-1.4% difference;","['1,660 patients', 'patients with severe aortic stenosis']","['TAVR', 'SURTAVI ', 'Transcatheter aortic valve replacement (TAVR', 'Surgical Replacement and Transcatheter Aortic Valve Implantation']","['mortality or disabling strokes', 'Kaplan-Meier rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}]","[{'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",1660.0,0.117764,"The Kaplan-Meier rate for the complete 2-year primary endpoint was 12.7% in the TAVR group and 12.6% in the surgery group (0.0% difference; 95% confidence interval: -3.4% to 3.5%), compared with 12.6% with TAVR and 14.0% with surgery (-1.4% difference;","[{'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Centre, Rotterdam, the Netherlands. Electronic address: n.vanmieghem@erasmusmc.nl.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': 'Department of Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Deeb', 'Affiliation': 'Cardiac Surgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Yakubov', 'Affiliation': 'Interventional Cardiology, OhioHealth Riverside Methodist Hospital, Columbus, Ohio.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Cardiovascular Science Division of the National Heart and Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Interventional Cardiology, University Hospital Bern, Bern, Switzerland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Søndergaard', 'Affiliation': 'The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mubashir', 'Initials': 'M', 'LastName': 'Mumtaz', 'Affiliation': 'Cardiac Surgery, University of Pittsburgh Medical Center Pinnacle Health, Harrisburg, Pennsylvania.'}, {'ForeName': 'Hemal', 'Initials': 'H', 'LastName': 'Gada', 'Affiliation': 'Interventional Cardiology, University of Pittsburgh Medical Center Pinnacle Health, Harrisburg, Pennsylvania.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Chetcuti', 'Affiliation': 'Interventional Cardiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Neal S', 'Initials': 'NS', 'LastName': 'Kleiman', 'Affiliation': 'Cardiology, Methodist DeBakey Heart and Vascular Center, Houston, Texas.'}, {'ForeName': 'Susheel', 'Initials': 'S', 'LastName': 'Kodali', 'Affiliation': 'Structural Heart and Valve Center, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'George', 'Affiliation': 'Structural Heart and Valve Center, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Teefy', 'Affiliation': 'Department of Medicine, Cardiology Division, London Health Sciences Centre, University Hospital, London, Ontario, Canada.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Kiaii', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, London Health Sciences Centre, University Hospital, London, Ontario, Canada.'}, {'ForeName': 'Jae K', 'Initials': 'JK', 'LastName': 'Oh', 'Affiliation': 'Echocardiography Core Laboratory, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Arie Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Baaken Research Center, Medical Affairs, Medtronic, Maastricht, the Netherlands.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Clinical, Medtronic, Mounds View, Minnesota.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Mugglin', 'Affiliation': 'Paradigm Biostatistics, Anoka, Minnesota.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Department of Cardiothoracic Surgery, Methodist DeBakey Heart and Vascular Center, Houston, Texas.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.10.043']
3018,31962003,Parental knowledge and attitudes regarding asthma in their children: Impact of an educational intervention in an Indian population.,"INTRODUCTION AND OBJECTIVES


Research shows positive effects of asthma education in improving parental knowledge, self-management skills, and reducing healthcare costs. Such studies are lacking in resource-limited countries. We studied the effectiveness of educational intervention in improving the knowledge and attitudes of parents/caregivers of asthmatic children.
METHODS


The study was conducted in the pediatric chest clinic of tertiary hospital (India) over 21 months after ethics committee approval. Recruited parents were randomized into the interventional group (A) receiving education module and control group (B). Parents' asthma knowledge and attitudes were assessed at baseline and 5 months postenrollment using 25-item questionnaire. Detailed demographic data, clinical data, and exacerbations during study were noted.
RESULTS


A total of 75 parents/guardians fulfilling inclusion criteria were analyzed (cases/group A: 37 and controls/group B: 38). 8.3 percent of parents/caregivers were illiterate. Around 36.9% of patients had a family history of allergy/asthma. Mean knowledge scores at follow-up were 12.24 and 9.89 for groups A and B, respectively (P < .05). Parents did better on knowledge items related to chronicity, family history, chronic cough, home administration of steroids in acute severe asthma, and maintaining records of clinical/medications for good control. Intervention group (A) showed significant improvement in most attitude-based questions postintervention as compared with the nonintervention group (B). There was no statistically significant difference in asthma severity and control between the two groups at follow-up.
CONCLUSIONS


Small group education on asthma in parents/caregivers improves their knowledge and attitudes. Healthcare plans should invest in pediatric asthma education and identify key personnel/opportunities to impart the same in routine care.",2020,Intervention group (A) showed significant improvement in most attitude-based questions postintervention as compared with the nonintervention group (B).,"['Indian population', 'parents/caregivers of asthmatic children', 'pediatric chest clinic of tertiary hospital (India) over 21 months after ethics committee approval', 'A total of 75 parents/guardians fulfilling inclusion criteria were analyzed']","['interventional group (A) receiving education module and control group (B', 'educational intervention']","['knowledge and attitudes', 'most attitude-based questions postintervention', 'Mean knowledge scores', 'asthma severity and control', ""Parents' asthma knowledge and attitudes""]","[{'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1274041', 'cui_str': 'Guardian'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0581122', 'cui_str': 'Asthma severity (regime/therapy)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]",75.0,0.0375521,Intervention group (A) showed significant improvement in most attitude-based questions postintervention as compared with the nonintervention group (B).,"[{'ForeName': 'Chhaya A', 'Initials': 'CA', 'LastName': 'Divecha', 'Affiliation': 'Department of Pediatrics, Seth G. S. Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Milind S', 'Initials': 'MS', 'LastName': 'Tullu', 'Affiliation': 'Department of Pediatrics, Seth G. S. Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Devika U', 'Initials': 'DU', 'LastName': 'Jadhav', 'Affiliation': 'Department of Pediatrics, Seth G. S. Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}]",Pediatric pulmonology,['10.1002/ppul.24647']
3019,32028458,Exercise Training Rapidly Increases Hepatic Insulin Extraction in NAFLD.,"PURPOSE


We aimed to determine the immediacy of exercise intervention on liver-specific metabolic processes in nonalcoholic fatty liver disease.
METHODS


We undertook a short-term (7-d) exercise training study (60 min·d treadmill walking at 80%-85% of maximal heart rate) in obese adults (N = 13, 58 ± 3 yr, 34.3 ± 1.1 kg·m, >5% hepatic lipid by H-magnetic resonance spectroscopy). Insulin sensitivity index was estimated by oral glucose tolerance test using the Soonthorpun model. Hepatic insulin extraction (HIE) was calculated as the molar difference in area under the curve (AUC) for insulin and C-peptide (HIE = 1 - (AUCInsulin/AUCC-Pep)).
RESULTS


The increases in HIE, V˙O2max, and insulin sensitivity index after the intervention were 9.8%, 9.8%, and 34%, respectively (all, P < 0.05). Basal fat oxidation increased (pre: 47 ± 6 mg·min vs post: 65 ± 6 mg·min, P < 0.05) and carbohydrate oxidation decreased (pre: 160 ± 20 mg·min vs post: 112 ± 15 mg·min, P < 0.05) with exercise training. After the intervention, HIE correlated positively with adiponectin (r = 0.56, P < 0.05) and negatively with TNF-α (r = -0.78, P < 0.001).
CONCLUSIONS


By increasing HIE along with peripheral insulin sensitivity, aerobic exercise training rapidly reverses some of the underlying physiological mechanisms associated with nonalcoholic fatty liver disease, in a weight loss-independent manner. This reversal could potentially act through adipokine-related pathways.",2020,"The increase in HIE, VO2max and ISI following the intervention was 9.8%, 9.8% and 34%, respectively (all P<0.05).","['obese adults (N=13, 58±3 years, 34.3±1.1 kg/m, >5% hepatic lipid by H-MR spectroscopy', 'Non-alcoholic fatty liver disease (NAFLD']","['Exercise Training', 'short-term (7-day) exercise training', 'carbohydrate oxidation', 'exercise intervention', 'exercise training', 'aerobic exercise training']","['Basal fat oxidation', 'Hepatic insulin extraction (HIE', 'HIE, VO2max and ISI', 'Insulin sensitivity (ISI', 'Hepatic Insulin Extraction']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0024487', 'cui_str': 'MR Spectroscopy'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",,0.0338532,"The increase in HIE, VO2max and ISI following the intervention was 9.8%, 9.8% and 34%, respectively (all P<0.05).","[{'ForeName': 'Adithya', 'Initials': 'A', 'LastName': 'Hari', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'CiarÀn E', 'Initials': 'CE', 'LastName': 'Fealy', 'Affiliation': 'Nutrition and Movement Sciences, Maastricht University, Maastricht, The NETHERLANDS.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Axelrod', 'Affiliation': 'Integrated Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Baton Rouge, LA.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Haus', 'Affiliation': 'Human Bioenergetics Laboratory, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Flask', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'McCullough', 'Affiliation': 'Department of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002273']
3020,32036610,Mixed hemodiafiltration reduces erythropoiesis stimulating agents requirement in dialysis patients: a prospective randomized study.,"BACKGROUND


Improved responsiveness to erythropoiesis stimulating agents (ESAs) in patients on on-line post-dilution hemodiafiltration (Post-HDF) compared with conventional hemodialysis (HD) was reported by some authors but challenged by others. This prospective, cross-over randomized study tested the hypothesis that an alternative infusion modality of HDF, mixed-dilution HDF (Mixed HDF), could further reduce ESAs requirement in dialysis patients compared to the traditional Post-HDF.
METHODS


One-hundred-twenty prevalent patients from 6 Dialysis Centers were randomly assigned to two six-months treatment sequences: A-B and B-A (A, Mixed HDF; B, Post-HDF). Primary outcome was comparative evaluation of ESA (darbepoetin alfa) requirement and ESA resistance. Treatments efficiency, iron and vitamins status, inflammation and nutrition parameters were monitored.
RESULTS


In sequence A, darbepoetin requirement decreased during Mixed HDF from 29.5 to 23.7 µg/month and increased significantly during Post-HDF (32.3 µg/month at 6th month) while, in sequence B, it increased during Post-HDF from 38.2 to 43.7 µg/month and decreased during Mixed HDF (23.9 µg/month at 6th month). Overall, EPO doses at 6 months on Mixed and Post-HDF were 23.8 and 38.4 µg/month, respectively, P < 0.01. A multiple linear model confirmed that Mixed HDF vs Post-HDF reduced significantly ESA requirement and ESA resistance (P < 0.0001), by a mean of 29% (CI 23-35%) in the last three months of the observation periods.
CONCLUSIONS


Mixed HDF decreased darbepoetin-alfa requirement in dialysis patients. This might help preventing the untoward side effects of high ESA doses, besides having a remarkable economic impact. Additional evidence is needed to confirm this potential benefit of Mixed-HDF.",2020,"A multiple linear model confirmed that Mixed HDF vs Post-HDF reduced significantly ESA requirement and ESA resistance (P < 0.0001), by a mean of 29% (CI 23-35%) in the last three months of the observation periods.
","['dialysis patients', 'One-hundred-twenty prevalent patients from 6 Dialysis Centers']","['erythropoiesis stimulating agents (ESAs', 'conventional hemodialysis (HD', 'HDF, mixed-dilution HDF (Mixed HDF', 'Mixed hemodiafiltration']","['Treatments efficiency, iron and vitamins status, inflammation and nutrition parameters', 'darbepoetin-alfa requirement', 'darbepoetin requirement decreased during Mixed HDF', 'comparative evaluation of ESA (darbepoetin alfa) requirement and ESA resistance', 'ESA requirement and ESA resistance']","[{'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1959590', 'cui_str': 'Erythropoiesis Stimulating Agents'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0079240', 'cui_str': 'Dilution Technics'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3472649', 'cui_str': 'ESAS'}]",120.0,0.0169487,"A multiple linear model confirmed that Mixed HDF vs Post-HDF reduced significantly ESA requirement and ESA resistance (P < 0.0001), by a mean of 29% (CI 23-35%) in the last three months of the observation periods.
","[{'ForeName': 'Luciano A', 'Initials': 'LA', 'LastName': 'Pedrini', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy. Luciano.pedrini@fmc-ag.com.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Comelli', 'Affiliation': 'Department of Brain and Behavioural Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Pio', 'Initials': 'P', 'LastName': 'Ruggiero', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Feliciani', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Vania', 'Initials': 'V', 'LastName': 'Manfrini', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Cozzi', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Castellano', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Pezzotta', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Gatti', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Arazzi', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Auriemma', 'Affiliation': 'Biochemistry Unit, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Attilio', 'Initials': 'A', 'LastName': 'di Benedetto', 'Affiliation': 'Medical Coordination NephroCare, Naples, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Stuard', 'Affiliation': 'Fresenius Medical Care, Clinical and Therapeutical Governance, Bad Homburg, Germany.'}]",Journal of nephrology,['10.1007/s40620-020-00709-0']
3021,31909561,What is a clinically meaningful change in exhaled nitric oxide for children with asthma?,"INTRODUCTION


Fractional exhaled nitric oxide (F E  NO) may be a useful objective measurement to guide asthma treatment. What remains uncertain is what change in F E  NO is clinically significant.
METHODS


An individual patient data analysis was performed using data from seven randomized clinical trials which used F E  NO to guide asthma treatment. The absolute and percentage intra-subject change in F E  NO measurements over ""stable"" and also ""unstable"" 3-month periods were described.
RESULTS


Data were available in 1112 randomized controlled trial participants and ≥1 stable period was present for 665 individuals. The interquartile range (IQR) and limits of agreement (LoA) for change in absolute F E  NO among individuals whose initial F E  NO was <50 parts per billion (ppb) were -7 to +9 ppb and -43 to +50 ppb, and for those with initial F E  NO ≥50 ppb IQR was -29 to +17 ppb and LoA was -80 to +76 ppb. For percentage change in F E  NO, the IQR and LoA for individuals whose initial F E  NO was <50 ppb were -33% to +51% and -157% to +215%, and for those with initial F E  NO ≥50 ppb were -33% to +35% and -159% to +192%. The variation in F E  NO values for a stable period was similar irrespective of whether it was followed by a stable or unstable period.
CONCLUSIONS


Over a 3-month period where F E  NO is initially <50 ppb, a rise of <10 ppb or of <50% (based on IQR) is unlikely to be related to asthma. When F E  NO is initially ≥50 ppb an percentage change of <50% (based on IQR) is unlikely to be asthma-related.",2020,"The variation in F E  NO values for a stable period was similar irrespective of whether it was followed by a stable or unstable period.
","['individuals', 'Data were available in 1112 randomized controlled trial participants and ≥1 stable period was present for 665 individuals', 'children with asthma']",[],['interquartile range (IQR) and limits of agreement (LoA'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4517848', 'cui_str': '665'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]",[],"[{'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0023923', 'cui_str': 'Loa'}]",1112.0,0.0298139,"The variation in F E  NO values for a stable period was similar irrespective of whether it was followed by a stable or unstable period.
","[{'ForeName': 'Shona', 'Initials': 'S', 'LastName': 'Fielding', 'Affiliation': 'Medical Statistics Team, Institute of Applied Health Sciences, University of Aberdeen, UK.'}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Pijnenburg', 'Affiliation': ""Department of Paediatric Respiratory Medicine and Allergology, Erasmus MC Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'de Jongste', 'Affiliation': ""Department of Paediatric Respiratory Medicine and Allergology, Erasmus MC Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Pike', 'Affiliation': 'Clinical and Experimental Science Academic Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'Clinical and Experimental Science Academic Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Petsky', 'Affiliation': ""Department of Respiratory and Sleep Medicine, Queensland's Children's Hospital, Queensland University of Technology, Brisbane, Australia.""}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Chang', 'Affiliation': ""Department of Respiratory and Sleep Medicine, Queensland's Children's Hospital, Queensland University of Technology, Brisbane, Australia.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fritsch', 'Affiliation': ""University Children's Hospital, Vienna, Austria.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Frischer', 'Affiliation': ""University Children's Hospital, Vienna, Austria.""}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Szefler', 'Affiliation': ""Department of Pediatrics, Breathing Institute, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gergen', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Paediatrics, Hôpital Erasme, Université Libre de Bruxelles (ULB), Brussels, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Vael', 'Affiliation': 'Department of Paediatrics, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Turner', 'Affiliation': 'Child Health, University of Aberdeen, UK.'}]",Pediatric pulmonology,['10.1002/ppul.24630']
3022,32044871,FORGOT CALCIUM? ADMISSION IONIZED-CALCIUM IN TWO CIVILIAN RANDOMIZED CONTROLLED TRIALS OF PRE-HOSPITAL PLASMA FOR TRAUMATIC HEMORRHAGIC SHOCK.,"BACKGROUND


Randomized clinical trials(RCTs) support the use of pre-hospital plasma in traumatic hemorrhagic shock, especially in long transports. The citrate added to plasma binds with calcium, yet most pre-hospital trauma protocols have no guidelines for calcium replacement. We reviewed the experience of two recent pre-hospital plasma RCTs regarding admission ionized-calcium (i-Ca) blood levels and its impact on survival. We hypothesized that pre-hospital plasma is associated with hypocalcemia, which in turn is associated with lower survival.
METHODS


We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation. Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm) were eligible. We use generalized linear mixed models with random intercepts and Cox proportional hazards models with robust standard errors to account for clustered data by institution. Hypocalcemia was defined as i-Ca<1.0mmol/L.
RESULTS


Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34). Pre-hospital plasma and control patients were similar regarding age, sex, ISS, blunt mechanism, and brain injury. Pre-hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03). Severe hypocalcemia was significantly associated with decreased survival(Adjusted Hazard Ratio:1.07;95%CI:1.02-1.13, p=0.01) and massive transfusion(aRR= 2.70;95%CI:1.13-6.46, p=0.03), after adjustment for confounders(randomization group, age, ISS, and shock index).
CONCLUSION


Pre-hospital plasma in civilian trauma is associated with hypocalcemia, which in turn predicts lower survival and massive transfusion. These data underscore the need for explicit calcium supplementation guidelines in pre-hospital hemotherapy.
LEVEL OF EVIDENCE


",2020,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","['Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm', 'Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34', 'We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation']",[],"['massive transfusion(aRR', 'Hypocalcemia', 'Severe hypocalcemia', 'rates of hypocalcemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043253', 'cui_str': 'Injuries, Nonpenetrating'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy (regime/therapy)'}]",[],"[{'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.275164,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","[{'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Tessmer', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Chapman', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pusateri', 'Affiliation': 'Combat Casualty Care Research Program, US Army Medical Research Materiel Command, Fort Detrick, Maryland.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Neal', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': 'University of Colorado.'}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002614']
3023,31873788,A single bout of resistance exercise improves postprandial lipid metabolism in overweight/obese men with prediabetes.,"AIMS/HYPOTHESIS


Prediabetes is associated with postprandial hypertriacylglycerolaemia. Resistance exercise acutely lowers postprandial plasma triacylglycerol (TG); however, the changes in lipid metabolism that mediate this reduction are poorly understood. The aim of this study was to identify the constitutive metabolic mechanisms underlying the changes in postprandial lipid metabolism after resistance exercise in obese men with prediabetes.
METHODS


We evaluated the effect of a single bout of whole-body resistance exercise (seven exercises, three sets, 10-12 repetitions at 80% of one-repetition maximum) on postprandial lipid metabolism in ten middle-aged (50 ± 9 years), overweight/obese (BMI: 33 ± 3 kg/m 2 ), sedentary men with prediabetes (HbA 1c  >38 but <48 mmol/mol [>5.7% but <6.5%]), or fasting plasma glucose >5.6 mmol/l but <7.0 mmol/l or 2 h OGTT glucose >7.8 mmol/l but <11.1 mmol/l). We used a randomised, crossover design with a triple-tracer mixed meal test (ingested [( 13 C 4 ) 3 ]tripalmitin, i.v. [U- 13 C 16 ]palmitate and [ 2 H 5 ]glycerol) to evaluate chylomicron-TG and total triacylglycerol-rich lipoprotein (TRL)-TG kinetics. We used adipose tissue and skeletal muscle biopsies to evaluate the expression of genes regulating lipolysis and lipid oxidation, skeletal muscle respirometry to evaluate oxidative capacity, and indirect calorimetry to assess whole-body lipid oxidation.
RESULTS


The single bout of resistance exercise reduced the lipaemic response to a mixed meal in obese men with prediabetes without changing chylomicron-TG or TRL-TG fractional clearance rates. However, resistance exercise reduced endogenous and meal-derived fatty acid incorporation into chylomicron-TG and TRL-TG. Resistance exercise also increased whole-body lipid oxidation, skeletal muscle mitochondrial respiration, oxidative gene expression in skeletal muscle, and the expression of key lipolysis genes in adipose tissue.
CONCLUSIONS/INTERPRETATION


A single bout of resistance exercise improves postprandial lipid metabolism in obese men with prediabetes, which may mitigate the risk for cardiovascular disease and type 2 diabetes.",2020,"Resistance exercise also increased whole-body lipid oxidation, skeletal muscle mitochondrial respiration, oxidative gene expression in skeletal muscle, and the expression of key lipolysis genes in adipose tissue.
","['ten middle-aged (50\u2009±\u20099\xa0years), overweight/obese (BMI: 33\u2009±\u20093\xa0kg/m 2 ), sedentary men with prediabetes (HbA 1c  >38 but <48\xa0mmol/mol [>5.7% but <6.5%]), or fasting plasma glucose >5.6\xa0mmol/l but <7.0\xa0mmol/l or 2', 'obese men with prediabetes', 'overweight/obese men with prediabetes', 'obese men with prediabetes without changing chylomicron-TG or TRL-TG fractional clearance rates']","['resistance exercise', 'U- 13 C 16 ]palmitate and [ 2 H 5 ]glycerol', 'Resistance exercise', 'single bout of whole-body resistance exercise (seven exercises, three sets, 10-12 repetitions at 80% of one-repetition maximum']","['chylomicron-TG and total triacylglycerol-rich lipoprotein (TRL)-TG kinetics', 'postprandial plasma triacylglycerol (TG', 'lipaemic response', 'postprandial lipid metabolism']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0008731', 'cui_str': 'Chylomicrons'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0729631', 'cui_str': 'C-13 isotope'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C0008731', 'cui_str': 'Chylomicrons'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",,0.0657195,"Resistance exercise also increased whole-body lipid oxidation, skeletal muscle mitochondrial respiration, oxidative gene expression in skeletal muscle, and the expression of key lipolysis genes in adipose tissue.
","[{'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Bittel', 'Affiliation': 'Program in Physical Therapy, Washington University, St Louis, Campus Box 8502, 4444 Forest Park Ave., St Louis, MO, 63110, USA. bittela@wusm.wustl.edu.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Bittel', 'Affiliation': 'Program in Physical Therapy, Washington University, St Louis, Campus Box 8502, 4444 Forest Park Ave., St Louis, MO, 63110, USA.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Mittendorfer', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Adewole L', 'Initials': 'AL', 'LastName': 'Okunade', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yoshino', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Lane C', 'Initials': 'LC', 'LastName': 'Porter', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Nada A', 'Initials': 'NA', 'LastName': 'Abumrad', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Dominic N', 'Initials': 'DN', 'LastName': 'Reeds', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'W Todd', 'Initials': 'WT', 'LastName': 'Cade', 'Affiliation': 'Program in Physical Therapy, Washington University, St Louis, Campus Box 8502, 4444 Forest Park Ave., St Louis, MO, 63110, USA.'}]",Diabetologia,['10.1007/s00125-019-05070-x']
3024,32024950,"Daratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS).","Current guidelines for smoldering multiple myeloma (SMM) recommend active monitoring until the onset of multiple myeloma (MM) before initiating treatment or enrollment in a clinical trial. Earlier intervention may delay progression to MM. In CENTAURUS, 123 patients with intermediate-risk or high-risk SMM were randomly assigned to daratumumab 16 mg/kg intravenously on extended intense (intense), extended intermediate (intermediate), or short dosing schedules. At the prespecified primary analysis (15.8-month median follow-up), the complete response (CR) rates (co-primary endpoint) were 2.4%, 4.9%, and 0% for intense, intermediate, and short dosing, respectively; the co-primary endpoint of CR rate >15% was not met. Progressive disease (PD)/death rates (number of patients who progressed or died divided by total duration of progression-free survival [PFS] in patient-years; co-primary endpoint) for intense, intermediate, and short dosing were 0.055 (80% confidence interval [CI], 0.014-0.096), 0.102 (80% CI, 0.044-0.160), and 0.206 (80% CI, 0.118-0.295), respectively, translating to a median PFS ≥24 months in all arms (P < 0.0001, <0.0001, and =0.0213, respectively). With longer follow-up (median follow-up, 25.9 months), CR rates were 4.9%, 9.8%, and 0% for intense, intermediate, and short dosing, respectively. PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms). Twenty-four-month PFS rates were 89.9% (90% CI, 78.5-95.4%), 82.0% (90% CI, 69.0-89.9%), and 75.3% (90% CI, 61.1-85.0%) for intense, intermediate, and short dosing, respectively. Pharmacokinetic analyses indicated that intense dosing maintained target-saturating trough concentrations in most patients throughout weekly, every-2-week, and every-4-week dosing periods. No new safety signals were observed. These data provide the basis for an ongoing phase 3 study of daratumumab in SMM.",2020,"PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms).","['patients with intermediate-risk or high-risk smoldering multiple myeloma', '123 patients with intermediate-risk or high-risk SMM']","['Daratumumab monotherapy', 'daratumumab 16\u2009mg/kg intravenously on extended intense (intense), extended intermediate (intermediate']","['Progressive disease (PD)/death rates', 'CR rates', 'CR rate', 'PD/death rates', 'PFS rates', 'complete response (CR) rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1531608', 'cui_str': 'Asymptomatic Multiple Myeloma'}]","[{'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",123.0,0.0578349,"PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms).","[{'ForeName': 'C Ola', 'Initials': 'CO', 'LastName': 'Landgren', 'Affiliation': 'Department of Medicine, Myeloma Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA. landgrec@mskcc.org.'}, {'ForeName': 'Ajai', 'Initials': 'A', 'LastName': 'Chari', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Yael C', 'Initials': 'YC', 'LastName': 'Cohen', 'Affiliation': 'Department of Hematology, Tel-Aviv Sourasky (Ichilov) Medical Center, and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Voorhees', 'Affiliation': 'Levine Cancer Institute/Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Estell', 'Affiliation': 'Haematology Department, Concord Cancer Centre, Concord Hospital, University of Sydney, Concord, NSW, Australia.'}, {'ForeName': 'Irwindeep', 'Initials': 'I', 'LastName': 'Sandhu', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Jenner', 'Affiliation': 'Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Department of Clinical Haematology, Nottingham University Hospitals, Nottinghamshire, UK.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, ""Seràgnoli"" Institute of Hematology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Niels W C J', 'Initials': 'NWCJ', 'LastName': 'van de Donk', 'Affiliation': 'Department of Hematology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Department of Hematology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'University Hospital Heidelberg and National Center of Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kuppens', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Bandekar', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Clemens', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Neff', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Heuck', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Craig C', 'Initials': 'CC', 'LastName': 'Hofmeister', 'Affiliation': 'Department of Hematology & Oncology, Winship Cancer Institute of Emory University, Atlanta, GA, USA. Craig.Hofmeister@emory.edu.'}]",Leukemia,['10.1038/s41375-020-0718-z']
3025,31945514,Effectiveness of using an educational video simulating the anatomical mechanism of shaking and smothering in a home-visit program to prevent self-reported infant abuse: A population-based quasi-experimental study in Japan.,"BACKGROUND


A video that simulates the anatomical mechanism of shaking the infant head, which may have a stronger impact on the viewer, and a tool to prevent self-reported smothering in response to crying, has never been investigated.
OBJECTIVE


To investigate whether watching an educational video at home visit at 2 months postpartum on infant crying and the dangers of shaking and smothering reduces self-reported shaking and smothering behaviors at 4 months postpartum.
METHOD


In a quasi-experimental study in A city in Japan, the video intervention was implemented at home visits by a midwife, public health nurse or trained volunteers when babies were 2 months old. At the 4-month health checkup, participants received a questionnaire about the video, self-reported shaking and smothering behaviors and other covariates. The impacts of watching the video and self-reported shaking or smothering were analyzed using multiple logistic regression.
RESULTS


In total, 5961 caregivers provided valid response for this study (valid response rate: 73.8 %). In the adjusted model, those who watched the video were 74 % less likely to shake their infants (odds ratio (OR): 0.36, 95 % confidence interval (CI): 0.21-0.64), 43 % were less likely to smother their infants (OR: 0.57, 95 % CI: 0.37-0.89), 52 % were less likely to shake or smother (OR: 0.48, 95 % CI: 0.33-0.69) their infants.
CONCLUSION


The educational video on infant crying and the dangers of shaking and smothering, with anatomical mechanism of shaking, may halve the risk of self-reported shaking and smothering at 4 months of age.",2020,"In the adjusted model, those who watched the video were 74 % less likely to shake their infants (odds ratio (OR): 0.36, 95 % confidence interval (CI): 0.21-0.64), 43 % were less likely to smother their infants (OR: 0.57, 95 % CI: 0.37-0.89), 52 % were less likely to shake or smother (OR: 0.48, 95 % CI: 0.33-0.69) their infants.
",[],[],[],[],[],[],,0.0526884,"In the adjusted model, those who watched the video were 74 % less likely to shake their infants (odds ratio (OR): 0.36, 95 % confidence interval (CI): 0.21-0.64), 43 % were less likely to smother their infants (OR: 0.57, 95 % CI: 0.37-0.89), 52 % were less likely to shake or smother (OR: 0.48, 95 % CI: 0.33-0.69) their infants.
","[{'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Global Health Promotion, Tokyo Medical and Dental University, Tokyo, Japan; Department of Social Medicine, National Research Institute for Child Health and Development, Tokyo, Japan. Electronic address: fujiwara.hlth@tmd.ac.jp.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Isumi', 'Affiliation': 'Department of Global Health Promotion, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Sampei', 'Affiliation': 'Department of Global Health Promotion, Tokyo Medical and Dental University, Tokyo, Japan; Department of Social Medicine, National Research Institute for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Fujiko', 'Initials': 'F', 'LastName': 'Yamada', 'Affiliation': 'Department of Global Health Promotion, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Systems and Control Engineering, Tokyo Institute of Technology, Tokyo, Japan.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104359']
3026,31356508,Physical Activity Is Higher in Patients with LVADs Compared to Chronic Heart Failure.,"PURPOSE


Left ventricular assist devices (LVADs) are associated with an increased aerobic capacity in patients with chronic heart failure (CHF). However, studies evaluating the impact of LVAD implantation on physical activity (PA) are lacking. The aim of this study was to compare daily PA levels in participants with LVADs with well-matched CHF participants.
METHODS


Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation. Participants underwent a cardiopulmonary exercise test to determine peak oxygen consumption (V[Combining Dot Above]O2 peak). PA was monitored continuously for seven consecutive days with an Actiheart monitor.
RESULTS


V[Combining Dot Above]O2 peak in the CHF group (12.3 ± 3.5 ml·kg·min) was not significantly different to the LVAD group prior to LVAD implantation (10.4 ± 2.1 ml·kg·min), but was lower than in the LVAD group following implantation (15.8 ± 4.3 ml·kg·min; p < 0.05). PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001). LVAD participants spent more time performing moderate intensity PA than their CHF counterparts, 26 (24-40) [median (IQR)] vs. 12 (9-16) min/day; p < 0.001. PA was correlated with V[Combining Dot Above]O2 peak (r = 0.582; p = 0.001) across participants in the CHF and LVAD groups.
CONCLUSION


Higher levels of PA were observed in participants with LVAD compared with patients with advanced CHF. This may be due to a higher V[Combining Dot Above]O2 peak, resulting in an improved capacity to perform activities of daily living with less symptoms.",2019,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"['Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation', 'patients with chronic heart failure (CHF', 'participants with LVADs with well-matched CHF participants']","['LVAD implantation', 'Left ventricular assist devices (LVADs', 'cardiopulmonary exercise test', 'LVAD']","['Dot Above]O2 peak', 'time performing moderate intensity PA', 'V[Combining Dot Above]O2 peak', 'PA', 'peak oxygen consumption (V[Combining Dot Above]O2 peak', 'Physical Activity', 'aerobic capacity', 'daily PA levels', 'Higher levels of PA']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",16.0,0.0464878,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Moreno-Suarez', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Liew', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Dembo', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Larbalestier', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002104']
3027,32057275,Digital Whole Slide Imaging Compared With Light Microscopy for Primary Diagnosis in Surgical Pathology.,"CONTEXT.—


The adoption of digital capture of pathology slides as whole slide images (WSI) for educational and research applications has proven utility.
OBJECTIVE.—


To compare pathologists' primary diagnoses derived from WSI versus the standard microscope. Because WSIs differ in format and method of observation compared with the current standard glass slide microscopy, this study is critical to potential clinical adoption of digital pathology.
DESIGN.—


The study enrolled a total of 2045 cases enriched for more difficult diagnostic categories and represented as 5849 slides were curated and provided for diagnosis by a team of 19 reading pathologists separately as WSI or as glass slides viewed by light microscope. Cases were reviewed by each pathologist in both modalities in randomized order with a minimum 31-day washout between modality reads for each case. Each diagnosis was compared with the original clinical reference diagnosis by an independent central adjudication review.
RESULTS.—


The overall major discrepancy rates were 3.64% for WSI review and 3.20% for manual slide review diagnosis methods, a difference of 0.44% (95% CI, -0.15 to 1.03). The time to review a case averaged 5.20 minutes for WSI and 4.95 minutes for glass slides. There was no specific subset of diagnostic category that showed higher rates of modality-specific discrepancy, though some categories showed greater discrepancy than others in both modalities.
CONCLUSIONS.—


WSIs are noninferior to traditional glass slides for primary diagnosis in anatomic pathology.",2020,"The overall major discrepancy rates were 3.64% for WSI review and 3.20% for manual slide review diagnosis methods, a difference of 0.44% (95% CI, -0.15 to 1.03).","['2045 cases enriched for more difficult diagnostic categories and represented as 5849 slides were curated and provided for diagnosis by a team of 19 reading pathologists separately as WSI or as glass slides viewed by light microscope', '2045 Cases']","['Digital Whole Slide Imaging', 'Light Microscopy']",['overall major discrepancy rates'],"[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0334866', 'cui_str': 'Pathologists'}, {'cui': 'C0017596', 'cui_str': 'Glass'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0491970', 'cui_str': 'Light microscope'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C0430389', 'cui_str': 'Optical Microscopy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}]",,0.144382,"The overall major discrepancy rates were 3.64% for WSI review and 3.20% for manual slide review diagnosis methods, a difference of 0.44% (95% CI, -0.15 to 1.03).","[{'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Borowsky', 'Affiliation': 'From the Department of Pathology and Laboratory Medicine, University of California, Davis, Sacramento (Borowsky, Bishop, Darrow, Gui, Jen, Walby).'}, {'ForeName': 'Eric F', 'Initials': 'EF', 'LastName': 'Glassy', 'Affiliation': 'The Affiliated Pathologists Medical Group, Rancho Dominguez, California (Glassy, Kallichanda).'}, {'ForeName': 'William Dean', 'Initials': 'WD', 'LastName': 'Wallace', 'Affiliation': 'UCLA Pathology & Lab Medicine, University of California, Los Angeles (Wallace).'}, {'ForeName': 'Nathash S', 'Initials': 'NS', 'LastName': 'Kallichanda', 'Affiliation': 'The Affiliated Pathologists Medical Group, Rancho Dominguez, California (Glassy, Kallichanda).'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Behling', 'Affiliation': 'The Pacific Rim Pathology Lab and Sharp Healthcare, San Diego, California (Behling, Mendoza, Molden, Saffer, Wixom).'}, {'ForeName': 'Dylan V', 'Initials': 'DV', 'LastName': 'Miller', 'Affiliation': 'Intermountain Central Laboratory, Salt Lake City, Utah (Miller, Albro, Cessna, Hall, Lloyd).'}, {'ForeName': 'Hemlata N', 'Initials': 'HN', 'LastName': 'Oswal', 'Affiliation': 'The Pathology Department, Lucent Pathology Partners Mercy San Juan Hospital, Carmichael, California (Oswal, SM Bauer, Cortez, Rodgers, Rodriguez).'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Feddersen', 'Affiliation': 'The Histology Lab, TriCore Reference Laboratories, Albuquerque, New Mexico (Feddersen, Martin, McConnell, Reynolds, Spigel, Stepenaskie).'}, {'ForeName': 'Omid R', 'Initials': 'OR', 'LastName': 'Bakhtar', 'Affiliation': 'Scripps Clinic Torrey Pines, La Jolla, California (Bakhtar, Ghandi).'}, {'ForeName': 'Arturo E', 'Initials': 'AE', 'LastName': 'Mendoza', 'Affiliation': 'The Pacific Rim Pathology Lab and Sharp Healthcare, San Diego, California (Behling, Mendoza, Molden, Saffer, Wixom).'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Molden', 'Affiliation': 'The Pacific Rim Pathology Lab and Sharp Healthcare, San Diego, California (Behling, Mendoza, Molden, Saffer, Wixom).'}, {'ForeName': 'Helene L', 'Initials': 'HL', 'LastName': 'Saffer', 'Affiliation': 'The Pacific Rim Pathology Lab and Sharp Healthcare, San Diego, California (Behling, Mendoza, Molden, Saffer, Wixom).'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Wixom', 'Affiliation': 'The Pacific Rim Pathology Lab and Sharp Healthcare, San Diego, California (Behling, Mendoza, Molden, Saffer, Wixom).'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Albro', 'Affiliation': 'Intermountain Central Laboratory, Salt Lake City, Utah (Miller, Albro, Cessna, Hall, Lloyd).'}, {'ForeName': 'Melissa H', 'Initials': 'MH', 'LastName': 'Cessna', 'Affiliation': 'Intermountain Central Laboratory, Salt Lake City, Utah (Miller, Albro, Cessna, Hall, Lloyd).'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Hall', 'Affiliation': 'Intermountain Central Laboratory, Salt Lake City, Utah (Miller, Albro, Cessna, Hall, Lloyd).'}, {'ForeName': 'Isaac E', 'Initials': 'IE', 'LastName': 'Lloyd', 'Affiliation': 'Intermountain Central Laboratory, Salt Lake City, Utah (Miller, Albro, Cessna, Hall, Lloyd).'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Bishop', 'Affiliation': 'From the Department of Pathology and Laboratory Medicine, University of California, Davis, Sacramento (Borowsky, Bishop, Darrow, Gui, Jen, Walby).'}, {'ForeName': 'Morgan A', 'Initials': 'MA', 'LastName': 'Darrow', 'Affiliation': 'From the Department of Pathology and Laboratory Medicine, University of California, Davis, Sacramento (Borowsky, Bishop, Darrow, Gui, Jen, Walby).'}, {'ForeName': 'Dorina', 'Initials': 'D', 'LastName': 'Gui', 'Affiliation': 'From the Department of Pathology and Laboratory Medicine, University of California, Davis, Sacramento (Borowsky, Bishop, Darrow, Gui, Jen, Walby).'}, {'ForeName': 'Kuang-Yu', 'Initials': 'KY', 'LastName': 'Jen', 'Affiliation': 'From the Department of Pathology and Laboratory Medicine, University of California, Davis, Sacramento (Borowsky, Bishop, Darrow, Gui, Jen, Walby).'}, {'ForeName': 'Julie Ann S', 'Initials': 'JAS', 'LastName': 'Walby', 'Affiliation': 'From the Department of Pathology and Laboratory Medicine, University of California, Davis, Sacramento (Borowsky, Bishop, Darrow, Gui, Jen, Walby).'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Bauer', 'Affiliation': 'The Pathology Department, Lucent Pathology Partners Mercy San Juan Hospital, Carmichael, California (Oswal, SM Bauer, Cortez, Rodgers, Rodriguez).'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Cortez', 'Affiliation': 'The Pathology Department, Lucent Pathology Partners Mercy San Juan Hospital, Carmichael, California (Oswal, SM Bauer, Cortez, Rodgers, Rodriguez).'}, {'ForeName': 'Pranav', 'Initials': 'P', 'LastName': 'Gandhi', 'Affiliation': 'Scripps Clinic Torrey Pines, La Jolla, California (Bakhtar, Ghandi).'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Rodgers', 'Affiliation': 'The Pathology Department, Lucent Pathology Partners Mercy San Juan Hospital, Carmichael, California (Oswal, SM Bauer, Cortez, Rodgers, Rodriguez).'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Rodriguez', 'Affiliation': 'The Pathology Department, Lucent Pathology Partners Mercy San Juan Hospital, Carmichael, California (Oswal, SM Bauer, Cortez, Rodgers, Rodriguez).'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Martin', 'Affiliation': 'The Histology Lab, TriCore Reference Laboratories, Albuquerque, New Mexico (Feddersen, Martin, McConnell, Reynolds, Spigel, Stepenaskie).'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'McConnell', 'Affiliation': 'The Histology Lab, TriCore Reference Laboratories, Albuquerque, New Mexico (Feddersen, Martin, McConnell, Reynolds, Spigel, Stepenaskie).'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Reynolds', 'Affiliation': 'The Histology Lab, TriCore Reference Laboratories, Albuquerque, New Mexico (Feddersen, Martin, McConnell, Reynolds, Spigel, Stepenaskie).'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Spigel', 'Affiliation': 'The Histology Lab, TriCore Reference Laboratories, Albuquerque, New Mexico (Feddersen, Martin, McConnell, Reynolds, Spigel, Stepenaskie).'}, {'ForeName': 'Shelly A', 'Initials': 'SA', 'LastName': 'Stepenaskie', 'Affiliation': 'The Histology Lab, TriCore Reference Laboratories, Albuquerque, New Mexico (Feddersen, Martin, McConnell, Reynolds, Spigel, Stepenaskie).'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Viktorova', 'Affiliation': 'Beckman Coulter, Inc., Miami, Florida (Viktorova, Magari).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Magari', 'Affiliation': 'Beckman Coulter, Inc., Miami, Florida (Viktorova, Magari).'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Wharton', 'Affiliation': 'Leica Biosystems Imaging, Inc., Danvers, Massachusetts (Wharton).'}, {'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Leica Biosystems, Vista, California (Qiu).'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Bauer', 'Affiliation': 'The Department of Pathology and Laboratory Medicine, Hospital for Special Surgery, Weill Cornell Medical College, New York, New York (TW Bauer).'}]",Archives of pathology & laboratory medicine,['10.5858/arpa.2019-0569-OA']
3028,31931025,"A randomised controlled trial to determine patient experience of a magnetostrictive stack scaler as compared to a piezoelectric scaler, in supportive periodontal therapy.","OBJECTIVES


To compare the pain/discomfort experienced by patients in supportive periodontal therapy, following treatment with a piezoelectric ultrasonic scaler, designed for use with warmed water irrigation, and a magnetostrictive ultrasonic scaler.
METHODS


This was a single-centre, randomised, split mouth study with regard to side, and crossover with regard to treatment order. Patients attending general dental practice for supportive periodontal therapy were randomised to receive treatment from one scaler on the left and the other scaler on the right-hand side of the mouth, the left side of the mouth always being treated first. The piezo scaler (Tigon+®) was used with room temperature irrigation for half of the participants (approx 20 °C) and warmed water irrigation (approx 36 °C) for the other half. The magnetostrictive scaler (Cavitron Select SPS 30K®) was used with room temperature irrigation (approx 20 °C) only. Participants rated their pain/discomfort, noise and vibration by VAS scale.
RESULTS


140 participants completed the study. Mean VAS scores for all measures were significantly better for the piezo scaler used with warm irrigation as compared to the magnetostrictive scaler p < 0.001. When both scalers were used with room temperature irrigant, there were no significant differences in the VAS scores between scalers (pain/discomfort, p = 0.68; noise p = 0.2; vibration p = 0.85).
CONCLUSIONS


Participants indicated to statistical significance, less pain/discomfort, noise and vibration when the piezo scaler (Tigon+®) device was used with warmed irrigant, compared to the magnetostrictive scaler (Cavitron Select SPS 30K®). There were no significant differences between the instruments when room temperature irrigant was used.
CLINICAL SIGNIFICANCE


Regular scaling in supportive periodontal therapy, is essential for maintenance of susceptible patients, however it can be painful due to dentine hypersensitivity deterring patients from attending. Using a piezo scaler with warm water improves patient quality of life and subsequent oral health. This may have positive effects on patient attendance.
ISRCTN REGISTERED


ISRCTN15573995.",2020,Mean VAS scores for all measures were significantly better for the piezo scaler used with warm irrigation as compared to the magnetostrictive scaler p < 0.001.,"['140 participants completed the study', 'Patients attending general dental practice for supportive periodontal therapy']","['magnetostrictive scaler (Cavitron Select SPS 30K®', 'piezo scaler (Tigon+®', 'supportive periodontal therapy', 'piezoelectric scaler', 'piezoelectric ultrasonic scaler', 'magnetostrictive stack scaler']","['pain/discomfort, noise and vibration by VAS scale', 'Mean VAS scores', 'VAS scores', 'patient quality of life and subsequent oral health', 'pain/discomfort, noise and vibration']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0017318', 'cui_str': 'General Practice, Dental'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4255078', 'cui_str': 'SPS'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1456803', 'cui_str': 'Ultrasonics'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0029162'}]",140.0,0.0447367,Mean VAS scores for all measures were significantly better for the piezo scaler used with warm irrigation as compared to the magnetostrictive scaler p < 0.001.,"[{'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'Daly', 'Affiliation': 'Periodontology, Clinical Trials Group, Bristol Dental School, University of Bristol, Lower Maudlin Street, Bristol, BS1 2LY, UK. Electronic address: S.Daly@bristol.ac.uk.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Newcombe', 'Affiliation': 'Cardiff University, Cardiff, CF10 3AT, UK. Electronic address: newcombe@cardiff.ac.uk.'}, {'ForeName': 'Nicholas C A', 'Initials': 'NCA', 'LastName': 'Claydon', 'Affiliation': 'Periodontology, Clinical Trials Group, Bristol Dental School, University of Bristol, Lower Maudlin Street, Bristol, BS1 2LY, UK. Electronic address: n.claydon@bristol.ac.uk.'}, {'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Seong', 'Affiliation': 'Periodontology, Clinical Trials Group, Bristol Dental School, University of Bristol, Lower Maudlin Street, Bristol, BS1 2LY, UK. Electronic address: J.Seong@bristol.ac.uk.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Periodontology, Clinical Trials Group, Bristol Dental School, University of Bristol, Lower Maudlin Street, Bristol, BS1 2LY, UK. Electronic address: Maria.Davies@bristol.ac.uk.'}, {'ForeName': 'Nicola X', 'Initials': 'NX', 'LastName': 'West', 'Affiliation': 'Periodontology, Clinical Trials Group, Bristol Dental School, University of Bristol, Lower Maudlin Street, Bristol, BS1 2LY, UK. Electronic address: n.x.west@bristol.ac.uk.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103279']
3029,31919090,Prognostic and predictive role of gene mutations in chronic lymphocytic leukemia: results from the pivotal phase III study COMPLEMENT1.,"Next generation sequencing studies in Chronic lymphocytic leukemia (CLL) have revealed novel genetic variants that have been associated with disease characteristics and outcome. The aim of this study was to evaluate the prognostic value of recurrent molecular abnormalities in patients with CLL. Therefore, we assessed their incidences and associations with other clinical and genetic markers in the prospective multicenter COMPLEMENT1 trial (treatment naive patients not eligible for intensive treatment randomized to chlorambucil (CHL) vs. ofatumumab-CHL (O-CHL)). Baseline samples were available from 383 patients (85.6%) representative of the total trial cohort. Mutations were analyzed by amplicon-based targeted next generation sequencing (tNGS). In 52.2% of patients we found at least one mutation and the incidence was highest in NOTCH1 (17.0%), followed by SF3B1 (14.1%), ATM (11.7%), TP53 (10.2%), POT1 (7.0%), RPS15 (4.4%), FBXW7 (3.4%), MYD88 (2.6%) and BIRC3 (2.3%). While most mutations lacked prognostic significance, TP53 (HR2.02,p<0.01), SF3B1 (HR1.66,p=0.01) and NOTCH1 (HR1.39,p=0.03) were associated with inferior PFS in univariate analysis. Multivariate analysis confirmed the independent prognostic role of TP53 for PFS (HR1.71,p=0.04) and OS (HR2.78,p=0.02) and of SF3B1 for PFS only (HR1.52,p=0.02). Notably, NOTCH1 mutation status separates patients with a strong and a weak benefit from ofatumumab addition to CHL (NOTCH1wt:HR0.50,p<0.01, NOTCH1mut:HR0.81,p=0.45). In summary, TP53 and SF3B1 were confirmed as independent prognostic and NOTCH1 as a predictive factor for reduced ofatumumab efficacy in a randomized chemo (immune)therapy CLL trial. These results validate NGS-based mutation analysis in a multicenter trial and provide a basis for expanding molecular testing in the prognostic workup of patients with CLL. ClinicalTrials.gov registration number: NCT00748189.",2020,"Multivariate analysis confirmed the independent prognostic role of TP53 for PFS (HR1.71,p=0.04) and OS (HR2.78,p=0.02) and of SF3B1 for PFS only (HR1.52,p=0.02).","['383 patients (85.6%) representative of the total trial cohort', 'patients with CLL', 'naive patients not eligible for intensive treatment randomized to', 'Chronic lymphocytic leukemia (CLL', 'chronic lymphocytic leukemia']",['chlorambucil (CHL) vs. ofatumumab-CHL (O-CHL'],"['POT1', 'RPS15', 'FBXW7', 'TP53']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C1832027', 'cui_str': 'ofatumumab'}]",[],383.0,0.156623,"Multivariate analysis confirmed the independent prognostic role of TP53 for PFS (HR1.71,p=0.04) and OS (HR2.78,p=0.02) and of SF3B1 for PFS only (HR1.52,p=0.02).","[{'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Tausch', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Beck', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Billy J', 'Initials': 'BJ', 'LastName': 'Jebaraj', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dolnik', 'Affiliation': 'Klinik fur Innere Medizin fur Hematologie, Onkologie und Tumorimmunologie, Charité Berlin.'}, {'ForeName': 'Deyan Y', 'Initials': 'DY', 'LastName': 'Yosifov', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""Department of Haematology, St. James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'Universitair Ziekenhuis Gent, Gent, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Janssens', 'Affiliation': 'Universitair Ziekenhuis Leuven, Leuven, Belgium.'}, {'ForeName': 'K Govind', 'Initials': 'KG', 'LastName': 'Babu', 'Affiliation': 'Kidwai Memorial Institute of Oncology, Bangalore, India.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Hematology and Cancer Prevention,School of Public Health,Silesian Medical University,Katowice,Poland.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Mayer', 'Affiliation': 'Department of Haematology-Oncology, University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Panagiotidis', 'Affiliation': 'University of Athens, Laikon General Hospital, Athens, Greece.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'McKeown', 'Affiliation': 'Oncology Global Medicines Development, AstraZeneca, Melbourn, UK.'}, {'ForeName': 'Ira V', 'Initials': 'IV', 'LastName': 'Gupta', 'Affiliation': 'GSK Oncology, GlaxoSmithKline, London, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Skorupa', 'Affiliation': 'Novartis Pharma GmbH, Nürnberg, Germany.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Pallaud', 'Affiliation': 'Novartis AG, Basel, Switzerland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bullinger', 'Affiliation': 'Klinik fur Innere Medizin fur Hematologie, Onkologie und Tumorimmunologie, Charité, Berlin.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mertens', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany; stephan.stilgenbauer@uniklinik-ulm.de.'}]",Haematologica,['10.3324/haematol.2019.229161']
3030,32018065,Schema modes as a common mechanism of change in personality pathology and functioning: Results from a randomized controlled trial.,"OBJECTIVE


We aimed to empirically test whether schema modes are central to the change process in schema therapy, clarification-oriented psychotherapy, and treatment as usual, i.e., predictive of personality pathology, and global and social-occupational functioning.
METHOD


A multicenter randomized controlled trial was conducted (N = 139 men, N = 181 women) over the course of three years. Repeated assessments of schema modes, personality disorder (PD) severity and functioning (controlled for concurrent PD-pathology) were analyzed using a multilevel autoregressive model. Variables were person-centered to ensure that within-person changes were analyzed. Through a process of backward elimination, the schema modes predictive of the dependent variable (i.e., PD-severity and functioning) at a later point in time were identified while controlling for concurrent dependent variable levels. Bidirectionality was tested by assessing whether dependent variables predicted later schema modes.
RESULTS


The Healthy Adult, Vulnerable Child, Impulsive Child, and Avoidant Protector predicted later personality pathology, with no bidirectionality observed for the first two. The Healthy Adult and Self-Aggrandizer predicted functioning at a later point in time, with no bidirectionality for Self-Aggrandizer. There was no moderation by treatment type for PD symptomatology, except for Self-Aggrandizer, which predicted functioning only in schema therapy.
CONCLUSIONS


The Healthy Adult and Vulnerable Child are central to the change process and appear to reflect common mechanisms of change. The Self-Aggrandizer might reflect a change mechanism specific for schema therapy. Our findings support the recent emphasis on these modes in schema therapy.",2020,"There was no moderation by treatment type for PD symptomatology, except for Self-Aggrandizer, which predicted functioning only in schema therapy.
","['N\xa0=\xa0139 men, N\xa0=\xa0181 women) over the course of three years']",[],"['schema modes, personality disorder (PD) severity and functioning (controlled for concurrent PD-pathology']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0031212', 'cui_str': 'Personality Disorders'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]",181.0,0.0749117,"There was no moderation by treatment type for PD symptomatology, except for Self-Aggrandizer, which predicted functioning only in schema therapy.
","[{'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Yakın', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Grasman', 'Affiliation': 'Department of Psychological Methods, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Arnoud', 'Initials': 'A', 'LastName': 'Arntz', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, the Netherlands. Electronic address: A.R.Arntz@uva.nl.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103553']
3031,32036479,The Physical Health Care Fidelity Scale: Psychometric Properties.,"Mental health programs need an instrument to monitor adherence to evidence-based physical health care for people with serious mental illness. The paper describes the Physical Health Care Fidelity Scale and study interrater reliability, frequency distribution, sensitivity to change and feasibility. Four fidelity assessments were conducted over 18 months at 13 sites randomized to implementation support for evidence-based physical health care. We found good to excellent interrater reliability, adequate sensitivity for change, good feasibility and wide variability in fidelity across sites after 18 months of implementation. Programs were more successful in establishing Policies stating physical health care standards than in implementing these Policies. The Physical Health Care Fidelity Scale measures and guides implementation of evidence-based physical health care reliably.Trial registration: ClinicalTrials.gov Identifier: NCT03271242.",2020,"We found good to excellent interrater reliability, adequate sensitivity for change, good feasibility and wide variability in fidelity across sites after 18 months of implementation.",['people with serious mental illness'],[],"['Physical Health Care Fidelity Scale and study interrater reliability, frequency distribution, sensitivity to change and feasibility']","[{'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]",[],"[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0222045'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0236868,"We found good to excellent interrater reliability, adequate sensitivity for change, good feasibility and wide variability in fidelity across sites after 18 months of implementation.","[{'ForeName': 'Torleif', 'Initials': 'T', 'LastName': 'Ruud', 'Affiliation': 'Division of Mental Health Services, Akershus University Hospital, Lørenskog, Norway. torleif.ruud@medisin.uio.no.'}, {'ForeName': 'Tordis Sørensen', 'Initials': 'TS', 'LastName': 'Høifødt', 'Affiliation': 'University Hospital Northern Norway, Tromsø, Norway.'}, {'ForeName': 'Delia Cimpean', 'Initials': 'DC', 'LastName': 'Hendrick', 'Affiliation': 'WestBridge, Manchester, NH, USA.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Drake', 'Affiliation': 'Westat, Lebanon, NH, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Høye', 'Affiliation': 'University Hospital Northern Norway, Tromsø, Norway.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Landers', 'Affiliation': 'Duke University, Durham, NC, USA.'}, {'ForeName': 'Kristin S', 'Initials': 'KS', 'LastName': 'Heiervang', 'Affiliation': 'Division of Mental Health Services, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Bond', 'Affiliation': 'Westat, Lebanon, NH, USA.'}]",Administration and policy in mental health,['10.1007/s10488-020-01019-0']
3032,23164687,Diurnal variation in serum alanine aminotransferase activity in the US population.,"GOALS AND BACKGROUND


Serum alanine aminotransferase (ALT) activity has been reported to be greater in the afternoon than the early morning, but data are scarce. We examined diurnal variation of ALT in a national population-based sample.
STUDY


Participants in the 1999 to 2008 US National Health and Nutrition Examination Survey were randomly assigned to morning (AM; n = 4474 adolescents, 11,235 adults) or afternoon/evening (PM; n = 4887 adolescents, 11,735 adults) examinations. We examined ALT distributions graphically and compared both geometric mean ALT and the prevalence of elevated ALT, defined as >31 IU/L for adolescent boys, >24 IU/L for adolescent girls, >43 IU/L for adult men, and >30 IU/L for adult women, between AM and PM examination groups.
RESULTS


The examination groups were similar with the exception in the AM group of a longer fasting time and slightly higher prevalence of diabetes among adolescents and viral hepatitis B among adult women. ALT distributions were similar between examination sessions among the 4 groups. Among adolescents and men, neither mean ALT nor prevalence of abnormal ALT differed by examination group. Among women, mean ALT was statistically significant, but minimally higher in the PM group (19.6 IU/L) than the AM group (19.1 IU/L; P = 0.009). Among 1 subgroup, women with chronic viral hepatitis, there was a higher prevalence of abnormal ALT in the PM group (P = 0.018 in unadjusted analysis). Adjusting for liver injury risk factors had little effect on the difference in mean ALT.
CONCLUSIONS


In general, clinically significant diurnal variation in ALT activity was not found in the US population.",2013,"Among women, mean ALT was statistically significant, but minimally higher in the PM group (19.6 IU/L) than the AM group (19.1 IU/L; P = 0.009).","['Participants in the 1999 to 2008 US National Health and Nutrition Examination Survey were randomly assigned to morning (AM; n = 4474 adolescents, 11,235 adults) or afternoon/evening (PM; n = 4887 adolescents, 11,735 adults) examinations', 'national population-based sample']",[],"['ALT activity', 'chronic viral hepatitis', 'mean ALT nor prevalence of abnormal ALT', 'prevalence of abnormal ALT', 'ALT distributions', 'serum alanine aminotransferase activity']","[{'cui': 'C0376344', 'cui_str': 'National Health and Nutrition Examination Survey'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]",[],"[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0276623', 'cui_str': 'Chronic viral hepatitis (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}]",11735.0,0.0604107,"Among women, mean ALT was statistically significant, but minimally higher in the PM group (19.6 IU/L) than the AM group (19.1 IU/L; P = 0.009).","[{'ForeName': 'Constance E', 'Initials': 'CE', 'LastName': 'Ruhl', 'Affiliation': 'Social & Scientific Systems Inc., Silver Spring, MD, USA. cruhl@s-3.com'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Everhart', 'Affiliation': ''}]",Journal of clinical gastroenterology,['10.1097/MCG.0b013e31826df40a']
3033,31601424,Connectivity of the Cognitive Control Network During Response Inhibition as a Predictive and Response Biomarker in Major Depression: Evidence From a Randomized Clinical Trial.,"BACKGROUND


In treating major depressive disorder, we lack tests anchored in neurobiology that predict antidepressant efficacy. Cognitive impairments are a particularly disabling feature of major depressive disorder. We tested whether functional connectivity during a response-inhibition task can predict response to antidepressants and whether its changes over time are correlated to symptom changes.
METHODS


We analyzed data from outpatients with major depressive disorder (n = 124) randomized to receive escitalopram, sertraline, or venlafaxine (8 weeks) and healthy control subjects (n = 59; age 18-65 years). Before and after treatment, participants were interviewed and scanned using functional magnetic resonance imaging, and functional connectivity was measured using generalized psychophysiological interaction during response inhibition (Go-NoGo task). We investigated the interaction between treatment type and response (≥50% reduction on self-reported symptoms), coupling differences between responders and nonresponders at baseline, their correlation with symptom improvement, and their changes in time.
RESULTS


During response inhibition, connectivity between the dorsolateral prefrontal cortex/supramarginal gyrus and supramarginal gyrus/middle temporal gyrus was associated with response to sertraline and venlafaxine, but not escitalopram. Sertraline responders had higher functional connectivity between these regions compared with nonresponders, whereas venlafaxine responders had lower functional connectivity. For sertraline, attenuation of connectivity in the precentral and superior temporal gyri correlated with posttreatment symptom improvement. For venlafaxine, enhancement of connectivity between the orbitofrontal cortex and subcortical regions correlated with symptom improvement.
CONCLUSIONS


Connectivity of the cognitive control circuit during response inhibition selectively and differentially predicts antidepressant treatment response and correlates with symptom improvement. These quantitative markers tied to the neurobiology of cognitive features of depression could be used translationally to predict and evaluate treatment response.",2020,"For sertraline, attenuation of connectivity in the precentral and superior temporal gyri correlated with posttreatment symptom improvement.","['Major Depression', 'outpatients with major depressive disorder (n\xa0= 124) randomized to receive', '8 weeks) and healthy control subjects (n\xa0= 59; age 18-65 years']","['Sertraline', 'sertraline and venlafaxine', 'venlafaxine', 'escitalopram, sertraline, or venlafaxine', 'Cognitive Control Network']",['functional connectivity'],"[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.103472,"For sertraline, attenuation of connectivity in the precentral and superior temporal gyri correlated with posttreatment symptom improvement.","[{'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Tozzi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Goldstein-Piekarski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California; Sierra-Pacific Mental Illness Research, Education, and Clinical Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California.'}, {'ForeName': 'Mayuresh S', 'Initials': 'MS', 'LastName': 'Korgaonkar', 'Affiliation': 'Brain Dynamics Centre, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia; Discipline of Psychiatry, Western Clinical School, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California; Sierra-Pacific Mental Illness Research, Education, and Clinical Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California. Electronic address: leawilliams@stanford.edu.'}]",Biological psychiatry,['10.1016/j.biopsych.2019.08.005']
3034,31954680,Mortality After Repeat Revascularization Following PCI or CABG for Left Main Disease: The EXCEL Trial.,"OBJECTIVES


The aim of this study was to investigate the incidence and impact on mortality of repeat revascularization after index percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD).
BACKGROUND


The impact on mortality of the need of repeat revascularization following PCI or CABG in patients with unprotected LMCAD is unknown.
METHODS


All patients with LMCAD and site-assessed low or intermediate SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) scores randomized to PCI (n = 948) or CABG (n = 957) in the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial were included. Repeat revascularization events were adjudicated by an independent clinical events committee. The effect of repeat revascularization on mortality through 3-year follow-up was examined in time-varying Cox regression models.
RESULTS


During 3-year follow-up, there were 346 repeat revascularization procedures among 185 patients. PCI was associated with higher rates of any repeat revascularization (12.9% vs. 7.6%; hazard ratio: 1.73; 95% confidence interval: 1.28 to 2.33; p = 0.0003). Need for repeat revascularization was independently associated with increased risk for 3-year all-cause mortality (adjusted hazard ratio: 2.05; 95% confidence interval: 1.13 to 3.70; p = 0.02) and cardiovascular mortality (adjusted hazard ratio: 4.22; 95% confidence interval: 2.10 to 8.48; p < 0.0001) consistently after both PCI and CABG (p int  = 0.85 for both endpoints). Although target vessel revascularization and target lesion revascularization were both associated with an increased risk for mortality, target vessel non-target lesion revascularization and non-target vessel revascularization were not.
CONCLUSIONS


In the EXCEL trial, repeat revascularization during follow-up was performed less frequently after CABG than PCI and was associated with increased mortality after both procedures. Reducing the need for repeat revascularization may further improve long-term survival after percutaneous or surgical treatment of LMCAD. (EXCEL Clinical Trial; NCT01205776).",2020,Need for repeat revascularization was independently associated with increased risk for 3-year all-cause mortality (adjusted hazard ratio: 2.05; 95% confidence interval:,"['185 patients', 'All patients with LMCAD and site-assessed low or intermediate SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) scores randomized to PCI (n\xa0=\xa0948) or', 'patients with unprotected LMCAD']","['index percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG', 'PCI or Coronary Artery Bypass Grafting', 'EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery', 'CABG']","['mortality', 'Repeat revascularization events', 'Mortality', 'cardiovascular mortality', 'risk for mortality, target vessel non-target lesion revascularization and non-target vessel revascularization', 'higher rates of any repeat revascularization']","[{'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0330199', 'cui_str': 'Taxus'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C2740529', 'cui_str': 'Excel'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",346.0,0.181929,Need for repeat revascularization was independently associated with increased risk for 3-year all-cause mortality (adjusted hazard ratio: 2.05; 95% confidence interval:,"[{'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Giustino', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Imperial College of Science, Technology and Medicine, London, United Kingdom.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': 'Department of Surgery, UH Cleveland Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maehara', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Puskas', 'Affiliation': ""Mount Sinai Heart at Mount Sinai St Luke's, New York, New York.""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Simonton', 'Affiliation': 'Abbott Vascular, Santa Clara, California.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Lembo', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, Georgia.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Ramsay Générale de Santé, Hopital Privé Jacques Cartier, Massy, France.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Taggart', 'Affiliation': 'Department Cardiac Surgery, John Radcliffe Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Anthony H', 'Initials': 'AH', 'LastName': 'Gershlick', 'Affiliation': 'University Hospitals of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ragosta', 'Affiliation': 'Division of Cardiovascular Medicine, University of Virginia Health System, Charlottesville, Virginia.'}, {'ForeName': 'Irving L', 'Initials': 'IL', 'LastName': 'Kron', 'Affiliation': 'Division of Cardiovascular Medicine, University of Virginia Health System, Charlottesville, Virginia.'}, {'ForeName': 'Yangbo', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Zixuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McAndrew', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Dressler', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Généreux', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey; Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Arie Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. Electronic address: gregg.stone@mountsinai.org.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.09.019']
3035,31981802,Test of an Anxiety Sensitivity Amelioration Program for at-risk youth (ASAP-Y).,"OBJECTIVE


Adult research supports the efficacy of targeting the malleable risk factor of anxiety sensitivity (AS) in preventing anxiety and related psychopathology. However, very little work has evaluated the impact of AS reduction among youth, which is unfortunate given adolescence is a ""core risk"" period in terms of disorder onset.
METHOD


The primary project aim was to test the effects of an Anxiety Sensitivity Amelioration Program for Youth (ASAP-Y) among a sample of 88 youth aged 10-14 years with elevated AS. High AS youth and a parent were randomly assigned to either the ASAP-Y, which consisted of psychoeducation and experimenter-led and parent-led exposures, or a general health information control condition.
RESULTS


Youth in the intervention condition sustained low AS levels across the intervention period, and although AS levels in both conditions decreased from baseline to the one-month assessment, this decrease was more pronounced at one-month for youth in the intervention condition. Further, significant indirect effects of condition on one-month anxiety and depression symptoms via reduced AS were detected. Homework compliance rates and self-report data support the acceptability of the ASAP-Y. Contrary to hypotheses, differences between conditions in emotional reactivity elicited using experimental psychopathology methods were not observed.
CONCLUSIONS


The current findings offer preliminary support for the ASAP-Y as an acceptable selective preventive intervention for at-risk youth, with specific anxiety- and depression-related effects through reduced AS.",2020,"The current findings offer preliminary support for the ASAP-Y as an acceptable selective preventive intervention for at-risk youth, with specific anxiety- and depression-related effects through reduced AS.","['Youth (ASAP-Y) among a sample of 88 youth aged 10-14 years with elevated AS', 'at-risk youth (ASAP-Y']","['ASAP-Y, which consisted of psychoeducation and experimenter-led and parent-led exposures, or a general health information control condition', 'Anxiety Sensitivity Amelioration Program']",[],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],88.0,0.0345051,"The current findings offer preliminary support for the ASAP-Y as an acceptable selective preventive intervention for at-risk youth, with specific anxiety- and depression-related effects through reduced AS.","[{'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Knapp', 'Affiliation': 'Center for Behavioral Intervention Technologies, Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, 750 N. Lake Shore Dr. 10th Floor, Chicago, IL, 60611, USA; Anxiety Research Program, Department of Psychological Science, University of Arkansas, 216 Memorial Hall, University of Arkansas, Fayetteville, AR, 72701, USA. Electronic address: ashley.knapp@northwestern.edu.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Feldner', 'Affiliation': 'Anxiety Research Program, Department of Psychological Science, University of Arkansas, 216 Memorial Hall, University of Arkansas, Fayetteville, AR, 72701, USA. Electronic address: mfeldne@gmail.com.'}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Allan', 'Affiliation': 'Factors of Emotional/Affective Risk Laboratory, Department of Psychology, Ohio University, Porter Hall 209, Athens, OH, 45701, USA. Electronic address: allan@ohio.edu.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Anxiety and Behavioral Health Clinic, Department of Psychology, Florida State University, 1107 West Call Street, Tallahassee, FL, 32306, USA. Electronic address: schmidt@psy.fsu.edu.'}, {'ForeName': 'Meghan E', 'Initials': 'ME', 'LastName': 'Keough', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, 1959 NE Pacific Street Box 356560, Seattle, WA, 98195, USA. Electronic address: meghankeough@gmail.com.'}, {'ForeName': 'Ellen W', 'Initials': 'EW', 'LastName': 'Leen-Feldner', 'Affiliation': 'Anxiety Research Program, Department of Psychological Science, University of Arkansas, 216 Memorial Hall, University of Arkansas, Fayetteville, AR, 72701, USA. Electronic address: eleenfe@uark.edu.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.103544']
3036,32014692,A randomized dismantling trial of the open and engaged components of acceptance and commitment therapy in an online intervention for distressed college students.,"This dismantling trial compared the effects of a full online Acceptance and Commitment Therapy (ACT) intervention to the isolated effects of the Open (i.e., acceptance, cognitive defusion) and Engaged (i.e., values, committed action) components of ACT. A sample of 181 distressed college students were randomized to one of four conditions: a 12-session full ACT website (Full), a version targeting the Open components (Open), a version targeting the Engaged components (Engaged), or waitlist. Participants in active conditions were also randomized to receive phone coaching or just email prompts to increase program adherence. All three ACT conditions significantly improved over time relative to the waitlist condition on the primary outcome of mental health symptoms. The Engaged and Full conditions had greater rates of reliable change on the primary outcome relative to waitlist, but not the Open condition. Similarly, only Engaged and Full conditions improved on positive mental health relative to waitlist. The Full condition had greater improvements on a few ACT process measures relative to Engaged and Open conditions, particularly cognitive fusion. Overall, results indicate targeting only the Open components of ACT was somewhat less effective, and that including both the Open and Engaged components led to greater decreases in cognitive fusion.",2020,"The Engaged and Full conditions had greater rates of reliable change on the primary outcome relative to waitlist, but not the Open condition.","['181 distressed college students', 'distressed college students', 'Participants in active conditions']","['12-session full ACT website (Full), a version targeting the Open components (Open), a version targeting the Engaged components (Engaged), or waitlist', 'open and engaged components of acceptance and commitment therapy', 'full online Acceptance and Commitment Therapy (ACT) intervention', 'phone coaching or just email prompts to increase program adherence']","['cognitive fusion', 'mental health symptoms', 'positive mental health']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",181.0,0.0550397,"The Engaged and Full conditions had greater rates of reliable change on the primary outcome relative to waitlist, but not the Open condition.","[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Levin', 'Affiliation': 'Utah State University, Department of Psychology, 2810 Old Main Hill, Logan, UT 84322, USA. Electronic address: Michael.Levin@usu.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Krafft', 'Affiliation': 'Utah State University, Department of Psychology, 2810 Old Main Hill, Logan, UT 84322, USA.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Hicks', 'Affiliation': 'Utah State University, Department of Psychology, 2810 Old Main Hill, Logan, UT 84322, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Pierce', 'Affiliation': 'Utah State University, Department of Psychology, 2810 Old Main Hill, Logan, UT 84322, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Twohig', 'Affiliation': 'Utah State University, Department of Psychology, 2810 Old Main Hill, Logan, UT 84322, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103557']
3037,32023233,Are There Differences in Micromotion on Radiostereometric Analysis Between Bicruciate and Cruciate-retaining Designs in TKA? A Randomized Controlled Trial.,"BACKGROUND


Bicruciate-retaining TKA has been proposed to improve clinical outcomes by maintaining intrinsic ACL function. However, because the unique design of the bicruciate-retaining tibial component precludes a tibial stem, fixation may be compromised. A radiostereometric analysis permits an evaluation of early migration of tibial components in this setting, but to our knowledge, no such analysis has been performed.
QUESTIONS/PURPOSES


We performed a randomized controlled trial using a radiostereometric analysis and asked, at 2 years: (1) Is there a difference in tibial implant migration between the bicruciate-retaining and cruciate-retaining TKA designs? In a secondary analysis, we asked: (2) Is there a difference in patient-reported outcomes (Oxford Knee Score [OKS] and Forgotten Joint Score [FJS] between the bicruciate-retaining and cruciate-retaining TKA designs? (3) What is the frequency of reoperations and revisions for the bicruciate-retaining and cruciate-retaining TKA designs?
METHODS


This parallel-group trial (ClinicalTrials.gov: NCT01966848) randomized 50 patients with an intact ACL who were eligible to undergo TKA to receive either a bicruciate-retaining or cruciate-retaining TKA. Patients were blinded to treatment allocation. The primary outcome was the maximum total point motion (MTPM) of the tibial component measured with model-based radiostereometric analysis (RSA) at 2 years postoperatively. The MTPM is a translation vector defined as the point in the RSA model that has the greatest combined translation in x-, y- and z-directions. A 1-year postoperative mean MTPM value of 1.6 mm has been suggested as a threshold for unacceptable increased risk of aseptic loosening after both 5 and 10 years. The repeatability of the MTPM was found to be 0.26 mm in our study. Patient-reported outcome measures were assessed preoperatively and at 2 years postoperatively with the OKS (scale of 0-48, worst-best) and FJS (scale of 0-100, worst-best). Baseline characteristics did not differ between groups. At 2 years postoperatively, RSA images were available for 22 patients who underwent bicruciate-retaining and 23 patients who underwent cruciate-retaining TKA, while patient-reported outcome measures were available for 24 patients in each group. The study was powered to detect a 0.2-mm difference in MTPM between groups (SD = 0.2, significance level = 5%, power = 80%).
RESULTS


With the numbers available, we found no difference in MTPM between the bicruciate-retaining and cruciate-retaining groups. The median (interquartile range [IQR]) MTPM was 0.52 mm (0.35 to 1.02) and 0.42 mm (0.34 to 0.70) in the bicruciate-retaining and cruciate-retaining groups, respectively (p = 0.63). There was no difference in the magnitude of improvement in the OKS from preoperatively to 2 years postoperative between the groups (median delta [IQR] for bicruciate-retaining 18 [14 to 23] versus cruciate-retaining 18 [15 to 21], difference of medians 0; p = 0.96). Likewise, there was no difference in the magnitude of improvement in the FJS score from preoperatively to 2 years postoperative between the groups (mean ± SD for bicruciate-retaining 46 ± 32 versus cruciate-retaining 48 ± 16, mean difference, 2; p = 0.80). Three patients in the bicruciate-retaining group underwent arthroscopically assisted manipulation at 3 to 4 months postoperatively, and one patient in the bicruciate-retaining group sustained a tibial island fracture during primary surgery and underwent a revision procedure after 6 months. There were no reoperations or revisions in the cruciate-retaining group.
CONCLUSIONS


With the numbers available, we found no differences between the bicruciate-retaining and the cruciate-retaining implants in terms of stable fixation on RSA or patient-reported outcome measure scores at 2 years, and must therefore recommend against the routine clinical use of the bicruciate-retaining device. The complications we observed with the bicruciate-retaining device suggest it has an associated learning curve and the associated risks of novelty with no demonstrable benefit to the patient; it is also likely to be more expensive in most centers. Continued research on this implant should only be performed in the context of controlled trials.
LEVEL OF EVIDENCE


Level II, therapeutic study.",2020,"There was no difference in the magnitude of improvement in the OKS from preoperatively to 2 years postoperative between the groups (median delta [IQR] for bicruciate-retaining 18 [14 to 23] versus cruciate-retaining 18 [15 to 21], difference of medians 0; p = 0.96).",['50 patients with an intact ACL who were eligible to undergo TKA to receive either a'],"['bicruciate-retaining group sustained a tibial island fracture during primary surgery and underwent a revision procedure', 'bicruciate-retaining or cruciate-retaining TKA']","['maximum total point motion (MTPM) of the tibial component measured with model-based radiostereometric analysis (RSA', 'patient-reported outcomes (Oxford Knee Score [OKS] and Forgotten Joint Score [FJS', 'MTPM', 'FJS score', 'tibial implant migration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}]","[{'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0022130', 'cui_str': 'Islands'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3178874', 'cui_str': 'Radiostereometry'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score (observable entity)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}]",50.0,0.100651,"There was no difference in the magnitude of improvement in the OKS from preoperatively to 2 years postoperative between the groups (median delta [IQR] for bicruciate-retaining 18 [14 to 23] versus cruciate-retaining 18 [15 to 21], difference of medians 0; p = 0.96).","[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Troelsen', 'Affiliation': 'A. Troelsen, L. H. Ingelsrud, M. G. Thomsen, K. S. Otte, H. Husted, Department of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark O. Muharemovic, Department of Radiology, Centre for Functional and Diagnostic Imaging and Research Copenhagen University Hospital Hvidovre, Copenhagen, Denmark.'}, {'ForeName': 'Lina Holm', 'Initials': 'LH', 'LastName': 'Ingelsrud', 'Affiliation': ''}, {'ForeName': 'Morten Grove', 'Initials': 'MG', 'LastName': 'Thomsen', 'Affiliation': ''}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Muharemovic', 'Affiliation': ''}, {'ForeName': 'Kristian Stahl', 'Initials': 'KS', 'LastName': 'Otte', 'Affiliation': ''}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Husted', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001077']
3038,32023234,"Does Circumferential Patellar Denervation Result in Decreased Knee Pain and Improved Patient-reported Outcomes in Patients Undergoing Nonresurfaced, Simultaneous Bilateral TKA?","BACKGROUND


Anterior knee pain, which has a prevalence of 4% to 49% after TKA, may be a cause of patient dissatisfaction after TKA. To limit the occurrence of anterior knee pain, patellar denervation with electrocautery has been proposed. However, studies have disagreed as to the efficacy of this procedure.Questions/purposes We evaluated patients undergoing bilateral, simultaneous TKA procedures without patellar resurfacing to ask: (1) Does circumferential patellar cauterization decrease anterior knee pain (Kujala score) postoperatively compared with non-cauterization of the patella? (2) Does circumferential patellar cauterization result in better functional outcomes based on patient report (VAS score, Oxford knee score, and Knee Injury and Osteoarthritis Outcome Score) than non-cauterization of the patella? (3) Is there any difference in the complication rate (infection, patellar maltracking, fracture, venous thromboembolism, or reoperation rate) between cauterized patellae and non-cauterized patellae?
METHODS


Seventy-eight patients (156 knees) were included in this prospective, quasi-randomized study, with each patient serving as his or her own control. Patellar cauterization was always performed on the right knee during simultaneous, bilateral TKA. Five patients (6%) were lost to follow-up before the 2-year minimum follow-up interval. A single surgeon performed all TKAs using the same type of implant, and osteophyte excision was performed in all patellae, which were left unresurfaced. Patellar cauterization was performed at 2 mm to 3 mm deep and approximately 5 mm circumferentially away from the patellar rim. The preoperative femorotibial angle and degree of osteoarthritis (according to the Kellgren-Lawrence grading system) were measured. Restoration of the patellofemoral joint was assessed using the anterior condylar ratio. Clinical outcomes, consisting of clinician-reported outcomes (ROM and Kujala score) and patient-reported outcomes (VAS pain score, Oxford knee score, and Knee Injury and Osteoarthritis Outcome Score), were evaluated preoperatively and at 1 month and 2 years postoperatively. Preoperatively, the radiologic severity of osteoarthritis, based on the Kellgren-Lawrence classification, was not different between the two groups, nor were the baseline pain and knee scores. The mean femorotibial angle of the two groups was also comparable: 189° ± 4.9° and 191° ± 6.3° preoperatively (p = 0.051) and 177° ± 2.9° and 178° ± 2.1° postoperatively (p = 0.751) for cauterized and non-cauterized knees, respectively. The preoperative (0.3 ± 0.06 versus 0.3 ± 0.07; p = 0.744) and postoperative (0.3 ± 0.06 versus 0.2 ± 0.07; p = 0.192) anterior condylar ratios were also not different between the cauterized and non-cauterized groups.
RESULTS


At the 2-year follow-up interval, no difference was observed in the mean Kujala score (82 ± 2.9 and 83 ± 2.6 for cauterized and non-cauterized knees, respectively; mean difference 0.3; 95% confidence interval, -0.599 to 1.202; p = 0.509). The mean VAS pain score was 3 ± 0.9 in the cauterized knee and 3 ± 0.7 in the non-cauterized knee (p = 0.920). The mean ROM was 123° ± 10.8° in the cauterized knee and 123° ± 10.2° in the non-cauterized knee (p = 0.783). There was no difference between cauterized and non-cauterized patellae in the mean Knee Injury and Osteoarthritis Outcome Score for symptoms (86 ± 4.5 versus 86 ± 3.9; p = 0.884), pain (86 ± 3.8 versus 86 ± 3.6; p = 0.905), activities (83 ± 3.2 versus 83 ± 2.8; p = 0.967), sports (42 ± 11.3 versus 43 ± 11.4; p = 0.942), and quality of life (83 ± 4.9 versus 83 ± 4.7; p = 0.916), as well as in the Oxford knee score (40 ± 2.1 versus 41 ± 1.9; p = 0.771). Complications were uncommon and there were no differences between the groups (one deep venous thromboembolism in the cauterized group and two in the control group; odds ratio 0.49, 95% CI, 0.04-5.56; p = 0.57).
CONCLUSIONS


Patellar cauterization results in no difference in anterior knee pain, functional outcomes, and complication rates compared with non-cauterization of the patella in patients who undergo non-resurfaced, simultaneous, bilateral, primary TKA with a minimum of 2 years of follow-up. We do not recommend circumferential patellar cauterization in non-resurfaced patellae in patients who undergo TKA.
LEVEL OF EVIDENCE


Level II, therapeutic study.",2020,"Complications were uncommon and there were no differences between the groups (one deep venous thromboembolism in the cauterized group and two in the control group; odds ratio 0.49, 95% CI, 0.04-5.56; p = 0.57).
","['patients who undergo TKA', 'Patients Undergoing Non-resurfaced, Simultaneous Bilateral Total Knee Arthroplasty', 'patients undergoing', 'Seventy-eight patients (156 knees']","['Patellar cauterization', 'bilateral, simultaneous TKA procedures without patellar resurfacing to ask: (1) Does circumferential patellar cauterization decrease anterior knee pain (Kujala score) postoperatively compared with non-cauterization of the patella', 'circumferential patellar cauterization']","['Clinical outcomes, consisting of clinician-reported outcomes (ROM and Kujala score) and patient-reported outcomes (VAS pain score, Oxford knee score, and Knee Injury and Osteoarthritis Outcome Score', 'patient report (VAS score, Oxford knee score, and Knee Injury and Osteoarthritis Outcome Score', 'radiologic severity of osteoarthritis', 'quality of life', 'mean Knee Injury and Osteoarthritis Outcome Score for symptoms', 'deep venous thromboembolism', 'mean VAS pain score', 'Knee Pain', 'mean femorotibial angle', 'anterior condylar ratios', 'mean Kujala score', 'Complications', 'patellofemoral joint', 'baseline pain and knee scores', 'pain', 'anterior knee pain, functional outcomes, and complication rates', 'mean ROM', 'complication rate (infection, patellar maltracking, fracture, venous thromboembolism, or reoperation rate', 'preoperative femorotibial angle and degree of osteoarthritis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0007471', 'cui_str': 'Cauterization'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030647', 'cui_str': 'Kneecap'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score (observable entity)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205483', 'cui_str': 'Radiologic (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0447801', 'cui_str': 'Patellofemoral Articulation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain (finding)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0427270', 'cui_str': 'Patellar maltracking (finding)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}]",,0.044867,"Complications were uncommon and there were no differences between the groups (one deep venous thromboembolism in the cauterized group and two in the control group; odds ratio 0.49, 95% CI, 0.04-5.56; p = 0.57).
","[{'ForeName': 'Nicolaas C', 'Initials': 'NC', 'LastName': 'Budhiparama', 'Affiliation': 'N. C. Budhiparama, H. Hidayat, K. Novito, I. Lumban-Gaol, Nicolaas Institute of Constructive Orthopaedic Research & Education Foundation for Arthroplasty & Sports Medicine at Medistra Hospital, Jakarta, Indonesia N. C. Budhiparama, D. N. Utomo, Department of Orthopaedic & Traumatology, Faculty of Medicine, Universitas Airlangga, Dr. Soetomo General Hospital, Surabaya, Indonesia N. C. Budhiparama, R. G. H. H. Nelissen, Department of Orthopaedic Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Hendy', 'Initials': 'H', 'LastName': 'Hidayat', 'Affiliation': ''}, {'ForeName': 'Kiki', 'Initials': 'K', 'LastName': 'Novito', 'Affiliation': ''}, {'ForeName': 'Dwikora Novembri', 'Initials': 'DN', 'LastName': 'Utomo', 'Affiliation': ''}, {'ForeName': 'Imelda', 'Initials': 'I', 'LastName': 'Lumban-Gaol', 'Affiliation': ''}, {'ForeName': 'Rob G H H', 'Initials': 'RGHH', 'LastName': 'Nelissen', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001035']
3039,31771387,Modulation of the rate of force development in hip abductor muscles by neuromuscular electrical stimulation during gait.,"Purpose/aim of the study:  An increase of hip abductor muscle strength contributes to the increase in gait speed. It is known that the rate of force development (RFD), an indicator of muscle strength, is increased by the combined use of low-intensity neuromuscular electrical stimulation (NMES) to the glutaeus medius (GM) and low-load resistance training (RT). However, it is unclear whether low-intensity neuromuscular electrical stimulation of the glutaeus medius during walking also increases the rate of force development. The aim of this study was to clarify whether NMES to the GM during gait modulates the RFD of the hip abductor muscles in healthy adults. Materials and methods:  Twenty-two healthy adults randomly received both gait with sub-motor threshold NMES and gait with sham NMES conditions. The RFD was assessed at pre- and post-intervention. A two-way repeated measures analysis of variance was used to analyse the effects of time and intervention. Results:  Gait with sub-motor threshold NMES condition significantly increased the RFD in shorter time interval (0-50 and 0-100 ms) compared to gait with sham NMES condition. Conclusions:  These findings suggest that the adding low-intensity NMES of the GM to gait is effective in increasing the RFD of the hip abductor muscles.",2020,Twenty-two healthy adults randomly received both gait with sub-motor threshold NMES and gait with sham NMES conditions.,"['Twenty-two healthy adults randomly received', 'healthy adults', 'hip abductor muscles by neuromuscular electrical stimulation during gait']","['both gait with sub-motor threshold NMES and gait with sham NMES conditions', 'NMES']","['gait speed', 'RFD', 'rate of force development']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C2927794', 'cui_str': 'RFD'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}]",22.0,0.0363606,Twenty-two healthy adults randomly received both gait with sub-motor threshold NMES and gait with sham NMES conditions.,"[{'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Takeda', 'Affiliation': 'Department of Rehabilitation, Kawamura Hospital, Gifu, Japan.'}, {'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Koyama', 'Affiliation': 'Faculty of Rehabilitation, School of Health Sciences, Fujita Health University, Toyoake, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Shomoto', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Science, Kio University, Nara, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Ushiroyama', 'Affiliation': 'Department of Rehabilitation, Kawamura Hospital, Gifu, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Naoi', 'Affiliation': 'Department of Rehabilitation, Kawamura Hospital, Gifu, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Sakurai', 'Affiliation': 'Faculty of Rehabilitation, School of Health Sciences, Fujita Health University, Toyoake, Japan.'}, {'ForeName': 'Yoshikiyo', 'Initials': 'Y', 'LastName': 'Kanada', 'Affiliation': 'Faculty of Rehabilitation, School of Health Sciences, Fujita Health University, Toyoake, Japan.'}, {'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Tanabe', 'Affiliation': 'Faculty of Rehabilitation, School of Health Sciences, Fujita Health University, Toyoake, Japan.'}]",Somatosensory & motor research,['10.1080/08990220.2019.1693357']
3040,31981227,A Pilot Randomized Controlled Trial to Assess the Impact of Motivational Interviewing on Initiating Behavioral Therapy for Migraine.,"BACKGROUND


Relaxation, biofeedback, and cognitive behavioral therapy are evidence-based behavioral therapies for migraine. Despite such efficacy, research shows that only about half of patients initiate behavioral therapy recommended by their headache specialists.
OBJECTIVE


Motivational interviewing (MI) is a widely used method to help patients explore and overcome ambivalence to enact positive life changes. We tested the hypothesis that telephone-based MI would improve initiation, scheduling, and attending behavioral therapy for migraine.
METHODS


Single-blind randomized controlled trial comparing telephone-based MI to treatment as usual (TAU). Participants were recruited during their appointments with headache specialists at two sites of a New York City medical center.
INCLUSION CRITERIA


ages from 16 to 80, migraine diagnosis by United Council of Neurologic Subspecialty fellowship trained and/or certified headache specialist, and referral for behavioral therapy for prevention in the appointment of recruitment.
EXCLUSION CRITERIA


having done behavioral therapy for migraine in the past year. Participants in the MI group received up to 5 MI calls. TAU participants were called after 3 months for general follow-up data. The prespecified primary outcome was scheduling a behavioral therapy appointment, and secondary outcomes were initiating and attending a behavioral therapy appointment.
RESULTS


76 patients were enrolled and randomized (MI = 36, TAU = 40). At baseline, the mean number of headache days was 12.0 ± 9.0. Self-reported anxiety was present for 36/52 (69.2%) and depression for 30/52 (57.7%). Follow-up assessments were completed for 77.6% (59/76, MI = 32, TAU = 27). The mean number of MI calls per participant was 2.69 ± 1.56 [0 to 5]. There was a greater likelihood of those in the MI group to initiating an appointment (22/32, 68.8% vs 11/27, 40.7%, P = .0309). There were no differences in appointment scheduling or attendance. Reasons stated for not initiating behavioral therapy were lack of time, lack of insurance/funding, prioritizing other treatments, and travel plans.
CONCLUSIONS


Brief telephone-based MI may improve rates of initiation of behavioral therapy for migraine, but other barriers appear to lessen the impact on scheduling and attending behavioral therapy appointments.",2020,"Follow-up assessments were completed for 77.6% (59/76, MI = 32, TAU = 27).","['Participants were recruited during their appointments with headache specialists at two sites of a New York City medical center', 'ages from 16 to 80, migraine diagnosis by United Council of Neurologic Subspecialty fellowship', 'Migraine', '76 patients']","['Motivational interviewing (MI', 'Motivational Interviewing', 'telephone-based MI to treatment as usual (TAU', 'telephone-based MI']","['mean number of MI calls', 'Self-reported anxiety', 'scheduling a behavioral therapy appointment, and secondary outcomes were initiating and attending a behavioral therapy appointment', 'mean number of headache days', 'appointment scheduling or attendance']","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0015770', 'cui_str': 'Fellowships'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1446911', 'cui_str': 'Scheduling'}]",76.0,0.056722,"Follow-up assessments were completed for 77.6% (59/76, MI = 32, TAU = 27).","[{'ForeName': 'Mia T', 'Initials': 'MT', 'LastName': 'Minen', 'Affiliation': 'Department of Neurology, New York University Langone Health, New York, NY, USA.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Sahyoun', 'Affiliation': 'Department of Neuroscience, Barnard College, Columbia University, New York, NY, USA.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Gopal', 'Affiliation': 'Department of Biology, The City College of New York, City University of New York, New York, NY, USA.'}, {'ForeName': 'Valeriya', 'Initials': 'V', 'LastName': 'Levitan', 'Affiliation': 'Department of Neurology, New York University Langone Health, New York, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Pirraglia', 'Affiliation': 'Department of Population, Biostatistics Division, New York University Langone Health, New York, NY, USA.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry, New York University Langone Health, New York, NY, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Halpern', 'Affiliation': 'Department of Neurology, New York University Langone Health, New York, NY, USA.'}]",Headache,['10.1111/head.13738']
3041,32020044,Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS.,"More effective treatment modalities are urgently needed in patients with acute myeloid leukemia (AML) of older age. We hypothesized that adding lenalidomide to intensive standard chemotherapy might improve their outcome. After establishing a safe lenalidomide, dose elderly patients with AML were randomly assigned in this randomized Phase 2 study (n = 222) to receive standard chemotherapy (""3 + 7"") with or without lenalidomide at a dose of 20 mg/day 1-21. In the second cycle, patients received cytarabine 1000 mg/m 2  twice daily on days 1-6 with or without lenalidomide (20 mg/day 1-21). The CR/CRi rates in the two arms were not different (69 vs. 66%). Event-free survival (EFS) at 36 months was 19% for the standard arm versus 21% for the lenalidomide arm and overall survival (OS) 35% vs. 30%, respectively. The frequencies and grade of adverse events were not significantly different between the treatment arms. Cardiovascular toxicities were rare and equally distributed between the arms. The results of the present study show that the addition of lenalidomide to standard remission induction chemotherapy does not improve the therapeutic outcome of older AML patients. This trial is registered as number NTR2294 in The NederlandsTrial Register (www.trialregister.nl).",2020,The frequencies and grade of adverse events were not significantly different between the treatment arms.,"['older AML patients', 'patients with acute myeloid leukemia (AML) of older age', 'elderly patients with AML', 'older patients with AML and high-risk MDS']","['Lenalidomide', 'cytarabine 1000\u2009mg/m 2  twice daily on days 1-6 with or without lenalidomide', 'standard chemotherapy (""3\u2009+\u20097"") with or without lenalidomide']","['frequencies and grade of adverse events', 'Event-free survival (EFS', 'CR/CRi rates', 'Cardiovascular toxicities', 'overall survival']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3179739', 'cui_str': '(LaCit2)3+'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.103256,The frequencies and grade of adverse events were not significantly different between the treatment arms.,"[{'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Ossenkoppele', 'Affiliation': 'Amsterdam University Medical Cente, location VUMC, Amsterdam, Netherlands. g.ossenkoppele@amsterdamumc.nl.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Breems', 'Affiliation': 'Netwerk Antwerpen, Antwerp, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Stuessi', 'Affiliation': 'Bellinzona-IOSI, Bellinzona, Switzerland.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'van Norden', 'Affiliation': 'HOVON Data Center, Erasmus MC- Department of Hematology, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bargetzi', 'Affiliation': 'Aarau- Kantonsspital, Aarau, Switzerland.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Biemond', 'Affiliation': 'Amsterdam University Medical Center, location AMC, Amsterdam, Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'A von dem Borne', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Chalandon', 'Affiliation': 'University Hospital and University of Geneva, Genève, Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cloos', 'Affiliation': 'Amsterdam University Medical Cente, location VUMC, Amsterdam, Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Deeren', 'Affiliation': 'Roeselare-AZ Delta, Roeselare, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fehr', 'Affiliation': 'St Gallen-Kantonnsspital, St. Gallen, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Gjertsen', 'Affiliation': 'Haukeland University Hospital, Bergen (N), Norway.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Graux', 'Affiliation': 'Yvoir-MontGodinne, Yvoir, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Huls', 'Affiliation': 'University Medical Center, Groningen, Netherlands.'}, {'ForeName': 'J J J W', 'Initials': 'JJJW', 'LastName': 'Janssen', 'Affiliation': 'Amsterdam University Medical Cente, location VUMC, Amsterdam, Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jaspers', 'Affiliation': 'Hôpital Citadelle, Liège (B), Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jongen-Lavrencic', 'Affiliation': 'Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'de Jongh', 'Affiliation': 'Dordrecht ASZ, Dordrecht, Netherlands.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Klein', 'Affiliation': 'Meander Medical Center, Amersfoort, Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van der Klift', 'Affiliation': 'Amphia-Breda, Breda, Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Marwijk Kooy', 'Affiliation': 'Isala Hospital, Zwolle, Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Maertens', 'Affiliation': 'Hospital Gasthuisberg, Leuven (B), Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Michaux', 'Affiliation': 'Center for Human Genetics, KU Leuven and University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'M W M', 'Initials': 'MWM', 'LastName': 'van der Poel', 'Affiliation': 'Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'van Rhenen', 'Affiliation': 'UMC Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tick', 'Affiliation': 'MaximaMC Eindhoven, Eindhoven, Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Valk', 'Affiliation': 'Hôpital Citadelle, Liège (B), Belgium.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Vekemans', 'Affiliation': 'Hôpital St Luc, Bruxelles, Belgium.'}, {'ForeName': 'W J F M', 'Initials': 'WJFM', 'LastName': 'van der Velden', 'Affiliation': 'Radboudumc Nijmegen, Nijmegen, Netherlands.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'de Weerdt', 'Affiliation': 'St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pabst', 'Affiliation': 'Department of Oncology, University Hospital, Inselspital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Manz', 'Affiliation': 'University Hospital, Zurich, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Löwenberg', 'Affiliation': 'Hôpital Citadelle, Liège (B), Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-020-0725-0']
3042,31710104,Rapid Onset of Effect of Galcanezumab for the Prevention of Episodic Migraine: Analysis of the EVOLVE Studies.,"OBJECTIVE


To evaluate onset of effect of galcanezumab in patients with episodic migraine.
BACKGROUND


Galcanezumab is a monoclonal antibody that binds to calcitonin gene-related peptide and is indicated for preventive treatment of migraine.
DESIGN/METHODS


Data on the primary outcome measure were analyzed from 2 previously published double-blind, Phase 3 studies (EVOLVE-1 [N = 858] and EVOLVE-2 [N = 915]) wherein adult patients with episodic migraine were randomized to receive monthly subcutaneous injections of galcanezumab 120 mg (with 240-mg loading dose) or 240 mg or placebo for up to 6 months. Monthly onset of effect was defined as the earliest month at which galcanezumab achieved and subsequently maintained statistical superiority to placebo on the mean change from baseline in the number of monthly migraine headache days (MHDs). If onset occurred in Month 1, weekly onset was evaluated and defined as the earliest week at which galcanezumab statistically separated from placebo and maintained statistical separation for remaining weeks in that month. Day of onset of effect was also analyzed, as were monthly and weekly onset, for occurrence of ≥50% reduction from baseline in number of MHDs.
RESULTS


For both studies, change from baseline in monthly MHDs showed a statistically significant separation of galcanezumab from placebo at Month 1 and each subsequent month (each P < .001). Analysis of the first month for both studies indicated onset of effect in the first week, with galcanezumab-treated patients having significantly higher odds of having fewer MHDs in the first week (odds ratio [95% confidence interval] for EVOLVE-1, 2.71 [2.00, 3.66], and for EVOLVE-2, 2.88 [2.16, 3.86]; both P < .001) and each subsequent week compared with placebo-treated patients (P ≤ .004). Daily analysis showed onset of effect at Day 1 (first day after injection day). Galcanezumab also demonstrated superiority to placebo on occurrence of ≥50% reduction in MHDs starting at Week 1 (percentage of patients with 50% response in galcanezumab group vs placebo group for EVOLVE-1, 54.3% vs 32.4% [P < .001], and for EVOLVE-2, 59.4% vs 38.0% [P < .001]).
CONCLUSION


Rapid onset of preventive effect on the first day after injection of galcanezumab was confirmed in both studies of episodic migraine.",2020,"For both studies, change from baseline in monthly MHDs showed a statistically significant separation of galcanezumab from placebo at Month 1 and each subsequent month (each P < .001).","['patients with episodic migraine.\nBACKGROUND', 'Data on the primary outcome measure were analyzed from 2 previously published double-blind, Phase 3 studies (EVOLVE-1 [N\xa0=\xa0858] and EVOLVE-2 [N\xa0=\xa0915]) wherein adult patients with episodic migraine']","['galcanezumab', 'placebo', 'galcanezumab 120 mg (with 240-mg loading dose) or 240 mg or placebo', 'Galcanezumab']",['number of monthly migraine headache days (MHDs'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332253', 'cui_str': 'Evolving (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",915.0,0.380542,"For both studies, change from baseline in monthly MHDs showed a statistically significant separation of galcanezumab from placebo at Month 1 and each subsequent month (each P < .001).","[{'ForeName': 'Holland C', 'Initials': 'HC', 'LastName': 'Detke', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Millen', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Samaan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ailani', 'Affiliation': 'MedStar Georgetown University, Washington, DC, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Department of Neurology, Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Sheena K', 'Initials': 'SK', 'LastName': 'Aurora', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]",Headache,['10.1111/head.13691']
3043,31115592,Effects of zoledronic acid on bone mineral density around prostheses and bone metabolism markers after primary total hip arthroplasty in females with postmenopausal osteoporosis.,"INTRODUCTION


To investigate the effect of zoledronic acid on periprosthetic bone mineral density (BMD) and bone metabolism markers after primary total hip arthroplasty in females with postmenopausal osteoporosis.
METHODS


From November 2015 to April 2016, 40 female patients who met the inclusion criteria were randomized into two groups: a control group (calcium + calcitriol) and a zoledronic acid group (calcium + calcitriol + zoledronic acid). At 1 week and 3, 6, and 12 months after operation, BMD was obtained through dual-energy X-ray absorptiometry (DEXA). At pre-operation and at 3, 6, and 12 months after the operation, levels of bone metabolism markers were obtained by serum examination.
RESULTS


Loss of BMD was significantly more pronounced in the control group than in the ZOL group in zones 1, 4, 6, and 7 at 6 months and in zones 1, 2, 4, 6, and 7 at 12 months after the operation. The levels of bone-resorption marker (β-CTX) were significantly lower in the ZOL group than in the control group at 3, 6, and 12 months after operation. The levels of bone-formation marker (TP1NP) performed statistically differences only at 12 months after the operation in these two groups.
CONCLUSIONS


Receiving an intravenous infusion of 5 mg zoledronic acid after THA can effectively reduce periprosthetic BMD loss and improve bone remodeling in females with postmenopausal osteoporosis. Zoledronic acid significantly inhibited bone mass loss in zones 1, 2, 4, 6, and 7 after THA and inhibited bone-resorption marker (β-CTX) to improve bone remodeling. Zoledronic acid treatment is potentially important for patients with osteoporosis after THA.",2019,"The levels of bone-resorption marker (β-CTX) were significantly lower in the ZOL group than in the control group at 3, 6, and 12 months after operation.","['primary total hip arthroplasty in females with postmenopausal osteoporosis', 'From November 2015 to April 2016, 40 female patients who met the inclusion criteria', 'patients with osteoporosis after THA', 'females with postmenopausal osteoporosis']","['control group (calcium + calcitriol', 'ZOL', 'zoledronic acid after THA', 'zoledronic acid', 'Zoledronic acid', 'zoledronic acid group (calcium + calcitriol + zoledronic acid']","['bone mass loss', 'levels of bone metabolism markers', 'BMD', 'periprosthetic bone mineral density (BMD) and bone metabolism markers', 'bone remodeling', 'levels of bone-resorption marker (β-CTX', 'bone mineral density around prostheses and bone metabolism markers', 'levels of bone-formation marker (TP1NP', 'periprosthetic BMD loss']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal Bone Loss'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0642413', 'cui_str': 'THAS'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0006674', 'cui_str': '1,25-dihydroxycholecalciferol'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}]",40.0,0.0146521,"The levels of bone-resorption marker (β-CTX) were significantly lower in the ZOL group than in the control group at 3, 6, and 12 months after operation.","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of University of Science and Technology of China, 17, Lu Jiang Road, Hefei, 230001, People's Republic of China.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Soochow University, 188, Shi Zi Road, Suzhou, 215006, People's Republic of China.""}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Soochow University, 188, Shi Zi Road, Suzhou, 215006, People's Republic of China.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Soochow University, 188, Shi Zi Road, Suzhou, 215006, People's Republic of China. Soochowspine@sina.com.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Soochow University, 188, Shi Zi Road, Suzhou, 215006, People's Republic of China. xuyaozeng@163.com.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Geng', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Soochow University, 188, Shi Zi Road, Suzhou, 215006, People's Republic of China. szgengdc@163.com.""}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-05005-7']
3044,31675102,Early Onset of Efficacy With Fremanezumab for the Preventive Treatment of Chronic Migraine.,"OBJECTIVE


To assess the onset of efficacy for fremanezumab in chronic migraine by evaluating pain-related clinical measures at different time points.
BACKGROUND


Faster onset of efficacy of preventive treatments could benefit patients with migraine. Fremanezumab is a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide, a neuropeptide involved in the pathophysiology of migraine. In 12-week clinical trials, subcutaneous fremanezumab significantly reduced the frequency of migraine headaches, headache hours, and headaches in general, without serious treatment-related adverse events. New drug classes of migraine preventive treatment demonstrate markedly different clinical profiles from standard-of-care treatments.
METHODS


In this double-blind phase III study, eligible patients were randomized 1:1:1 to receive subcutaneous injections of fremanezumab quarterly (675 mg at baseline, placebo at weeks 4 and 8), fremanezumab monthly (675 mg at baseline, 225 mg at weeks 4 and 8), or placebo at each time point. This study included secondary, exploratory, and post hoc analyses of the primary trial, evaluating the change in headache days of at least moderate severity or migraine days during the first 4 weeks of the trial.
RESULTS


A total of 1130 patients were randomized (fremanezumab quarterly, n = 376; fremanezumab monthly, n = 379; or placebo, n = 375). During the 4-week period after the first dose, the mean number of monthly headache days of at least moderate severity was reduced for the all-fremanezumab group (mean reduction [95% confidence interval]: -4.6 days [-5.1, -4.1]) compared with the placebo group (-2.3 days [-2.9, -1.6]; P < .0001). Treatment effects were observed at Week 1 for the all-fremanezumab group (-1.1 days [-1.3, -1.0]) vs placebo (-0.5 days [-0.7, -0.3]; P < .0001), with separation from placebo by Day 2 (P = .003). Similar effects were observed for the monthly average number of migraine days and mean number of monthly headache hours.
CONCLUSIONS


The early onset of efficacy of fremanezumab may have the potential to improve patient compliance and clinical outcomes.",2019,"In 12-week clinical trials, subcutaneous fremanezumab significantly reduced the frequency of migraine headaches, headache hours, and headaches in general, without serious treatment-related adverse events.","['1130 patients were randomized (fremanezumab quarterly, n\xa0', 'patients with migraine', 'Chronic Migraine', 'eligible patients']","['fremanezumab', 'Fremanezumab', 'placebo', 'subcutaneous injections of fremanezumab quarterly (675\xa0mg at baseline, placebo', 'subcutaneous fremanezumab']","['headache days of at least moderate severity or migraine days', 'frequency of migraine headaches, headache hours, and headaches in general, without serious treatment-related adverse events', 'mean number of monthly headache days of at least moderate severity', 'migraine days and mean number of monthly headache hours']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0332179', 'cui_str': 'q3mo'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1960870', 'cui_str': 'Chronic migraine'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C0332179', 'cui_str': 'q3mo'}, {'cui': 'C4517854', 'cui_str': '675 (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}]",1130.0,0.368358,"In 12-week clinical trials, subcutaneous fremanezumab significantly reduced the frequency of migraine headaches, headache hours, and headaches in general, without serious treatment-related adverse events.","[{'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Winner', 'Affiliation': 'Premiere Research Institute, West Palm Beach, FL, USA.'}, {'ForeName': 'Egilius L H', 'Initials': 'ELH', 'LastName': 'Spierings', 'Affiliation': 'MedVadis Research Corporation, Watertown, MA, USA.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Yeung', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Aycardi', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Blankenbiller', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Grozinski-Wolff', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Yuju', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}]",Headache,['10.1111/head.13654']
3045,32001798,"Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study.","In POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd) reduced the risk of disease progression or death by 63% and increased the overall response rate (ORR) versus Rd in relapsed/refractory multiple myeloma (RRMM). Updated efficacy and safety after >3 years of follow-up are presented. Patients (N = 569) with ≥1 prior line received Rd (lenalidomide, 25 mg, on Days 1-21 of each 28-day cycle; dexamethasone, 40 mg, weekly) ± daratumumab at the approved dosing schedule. Minimal residual disease (MRD) was assessed by next-generation sequencing. After 44.3 months median follow-up, D-Rd prolonged progression-free survival (PFS) in the intent-to-treat population (median 44.5 vs 17.5 months; HR, 0.44; 95% CI, 0.35-0.55; P < 0.0001) and in patient subgroups. D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001). Median time to next therapy was prolonged with D-Rd (50.6 vs 23.1 months; HR, 0.39; 95% CI, 0.31-0.50; P < 0.0001). Median PFS on subsequent line of therapy (PFS2) was not reached with D-Rd versus 31.7 months with Rd (HR, 0.53; 95% CI, 0.42-0.68; P < 0.0001). No new safety concerns were reported. These data support using D-Rd in patients with RRMM after first relapse.",2020,"D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001).","['Patients (N\u2009=\u2009569) with ≥1 prior line received', 'relapsed/refractory multiple myeloma']","['Rd (lenalidomide', 'POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd', 'Daratumumab plus lenalidomide and dexamethasone', 'dexamethasone, 40\u2009mg, weekly)\u2009±\u2009daratumumab']","['Median time to next therapy', 'D-Rd prolonged progression-free survival (PFS', 'risk of disease progression or death', 'MRD negativity', 'Minimal residual disease (MRD', 'overall response rate (ORR', 'ORR', 'Median PFS on subsequent line of therapy (PFS2']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]",569.0,0.152505,"D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001).","[{'ForeName': 'Nizar J', 'Initials': 'NJ', 'LastName': 'Bahlis', 'Affiliation': 'University of Calgary, Charbonneau Cancer Research Institute, Calgary, AB, Canada. nbahlis@ucalgary.ca.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'The National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Darrell J', 'Initials': 'DJ', 'LastName': 'White', 'Affiliation': 'QEII Health Sciences Center and Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Lotfi', 'Initials': 'L', 'LastName': 'Benboubker', 'Affiliation': ""Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire (CHRU), Tours, France.""}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': ""St James's Institute of Oncology, Leeds Teaching Hospitals National Health Service Trust and University of Leeds, Leeds, UK.""}, {'ForeName': 'Merav', 'Initials': 'M', 'LastName': 'Leiba', 'Affiliation': 'Assuta University Hospital, Faculty of Health Science, Ben-Gurion University of the Negev, Beersheba, Israel.'}, {'ForeName': 'P Joy', 'Initials': 'PJ', 'LastName': 'Ho', 'Affiliation': 'Institute of Haematology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Kihyun', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Takezako', 'Affiliation': 'Department of Hematology, National Hospital Organization Disaster Medical Center of Japan, Tachikawa, Japan.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Hematology, University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Krevvata', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chiu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Okonkwo', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Trivedi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Global Medical Affairs, Horsham, PA, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'San-Miguel', 'Affiliation': 'Clínica Universidad de Navarra-Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra, Centro de Investigación Biomédica en Red de Cáncer, Pamplona, Spain.'}]",Leukemia,['10.1038/s41375-020-0711-6']
3046,32015491,"Clinical significance of TP53, BIRC3, ATM and MAPK-ERK genes in chronic lymphocytic leukaemia: data from the randomised UK LRF CLL4 trial.","Despite advances in chronic lymphocytic leukaemia (CLL) treatment, globally chemotherapy remains a central treatment modality, with chemotherapy trials representing an invaluable resource to explore disease-related/genetic features contributing to long-term outcomes. In 499 LRF CLL4 cases, a trial with >12 years follow-up, we employed targeted resequencing of 22 genes, identifying 623 mutations. After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1). Mutations beyond Sanger resolution (<12% VAF) were observed in all genes, with KRAS mutations principally composed of these low VAF variants. Firstly, employing orthogonal approaches to confirm <12% VAF TP53 mutations, we assessed the clinical impact of TP53 clonal architecture. Whilst ≥ 12% VAF TP53mut cases were associated with reduced PFS and OS, we could not demonstrate a difference between <12% VAF TP53 mutations and either wild type or ≥12% VAF TP53mut cases. Secondly, we identified biallelic BIRC3 lesions (mutation and deletion) as an independent marker of inferior PFS and OS. Finally, we observed that mutated MAPK-ERK genes were independent markers of poor OS in multivariate survival analysis. In conclusion, our study supports using targeted resequencing of expanded gene panels to elucidate the prognostic impact of gene mutations.",2020,"After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1).","['chronic lymphocytic leukaemia (CLL', 'chronic lymphocytic leukaemia', '499 LRF CLL4 cases, a trial with >12 years follow-up, we employed targeted resequencing of 22 genes, identifying 623 mutations']",[],"['PFS and OS', 'Mutations beyond Sanger resolution', 'biallelic BIRC3 lesions (mutation and deletion']","[{'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]",[],"[{'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}]",,0.0594031,"After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1).","[{'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Blakemore', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Clifford', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Parker', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Pavlos', 'Initials': 'P', 'LastName': 'Antoniou', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Stec-Dziedzic', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Larrayoz', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Zadie', 'Initials': 'Z', 'LastName': 'Davis', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Latha', 'Initials': 'L', 'LastName': 'Kadalyayil', 'Affiliation': 'Genetic Epidemiology and Bioinformatics, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Colins', 'Affiliation': 'Genetic Epidemiology and Bioinformatics, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Robbe', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Vavoulis', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Forster', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Carr', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Morilla', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Else', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Bryant', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McCarthy', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Renata J', 'Initials': 'RJ', 'LastName': 'Walewska', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Steele', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Oxford Gene Technology, Begbroke Science Park, Begbroke, Oxfordshire, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Speight', 'Affiliation': 'Oxford Gene Technology, Begbroke Science Park, Begbroke, Oxfordshire, UK.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Stankovic', 'Affiliation': 'Institute of Cancer and Genomic Sciences, College of Medical and Dental Services, IBR West, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Cragg', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Catovsky', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Oscier', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Matthew J J', 'Initials': 'MJJ', 'LastName': 'Rose-Zerilli', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Schuh', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Strefford', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK. jcs@soton.ac.uk.'}]",Leukemia,['10.1038/s41375-020-0723-2']
3047,31865749,Barriers and Facilitators in the Recruitment and Retention of More Than 250 Small Independent Primary Care Practices for EvidenceNOW.,"Few studies have examined factors that facilitate recruitment of small independent practices (SIPs) (<5 full-time clinicians) to participate in research and methods for optimizing retention. The authors analyzed qualitative data (eg, recruiter's field notes and diary entries, provider interviews) to identify barriers and facilitators encountered in recruiting and retaining 257 practices in HealthyHearts New York City (NYC). This study was a stepped-wedge randomized controlled trial that took place 2015 through 2018 across 5 boroughs in NYC. Three main factors facilitated rapid recruitment: (1) a prior well-established relationship with the local health department, (2) alignment of project goals with practice priorities, and (3) providing appropriate monetary incentives. Retention was facilitated through similar mechanisms and an ongoing multifaceted communication strategy. This article identifies specific strategies that enhance recruitment of SIPs and fills gaps in knowledge about factors that influence retention in the context of a design that requires waiting to receive the intervention.",2020,Few studies have examined factors that facilitate recruitment of small independent practices (SIPs) (<5 full-time clinicians) to participate in research and methods for optimizing retention.,['took place 2015 through 2018 across 5 boroughs in NYC'],['barriers and facilitators encountered in recruiting and retaining 257 practices in HealthyHearts New York City (NYC'],[],"[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}]","[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]",[],5.0,0.112668,Few studies have examined factors that facilitate recruitment of small independent practices (SIPs) (<5 full-time clinicians) to participate in research and methods for optimizing retention.,"[{'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Cuthel', 'Affiliation': 'New York University School of Medicine, New York, NY.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Rogers', 'Affiliation': 'New York University School of Medicine, New York, NY.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Daniel', 'Affiliation': 'New York City Department of Health and Mental Hygiene, Queens, NY.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Carroll', 'Affiliation': 'New York City Department of Health and Mental Hygiene, Queens, NY.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Pham-Singer', 'Affiliation': 'New York City Department of Health and Mental Hygiene, Queens, NY.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shelley', 'Affiliation': 'New York University School of Medicine, New York, NY.'}]",American journal of medical quality : the official journal of the American College of Medical Quality,['10.1177/1062860619893422']
3048,31307535,"Arthritis prevention in the pre-clinical phase of RA with abatacept (the APIPPRA study): a multi-centre, randomised, double-blind, parallel-group, placebo-controlled clinical trial protocol.","TRIAL DESIGN


We present a study protocol for a multi-centre, randomised, double-blind, parallel-group, placebo-controlled trial that seeks to test the feasibility, acceptability and effectiveness of a 52-week period of treatment with the first-in-class co-stimulatory blocker abatacept for preventing or delaying the onset of inflammatory arthritis.
METHODS


The study aimed to recruit 206 male or female subjects from the secondary care hospital setting across the UK and the Netherlands. Participants who were at least 18 years old, who reported inflammatory sounding joint pain (clinically suspicious arthralgia) and who were found to be positive for serum autoantibodies associated with rheumatoid arthritis (RA) were eligible for enrolment. All study subjects were randomly assigned to receive weekly injections of investigational medicinal product, either abatacept or placebo treatment over the course of a 52-week period. Participants were followed up for a further 52 weeks. The primary endpoint was defined as the time to development of at least three swollen joints or to the fulfilment of the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA using swollen but not tender joints, whichever endpoint was met first. In either case, swollen joints were confirmed by ultrasonography. Participants, care givers, and those assessing the outcomes were all blinded to group assignment. Clinical assessors and ultrasonographers were also blinded to each other's assessments for the duration of the study.
CONCLUSIONS


There is limited experience of the design and implementation of trials for the prevention of inflammatory joint diseases. We discuss the rationale behind choice and duration of treatment and the challenges associated with defining the ""at risk"" state and offer pragmatic solutions in the protocol to enrolling subjects at risk of RA.
TRIAL REGISTRATION


Current Controlled Trials, ID: ISRCTN46017566 . Registered on 4 July 2014.",2019,"The primary endpoint was defined as the time to development of at least three swollen joints or to the fulfilment of the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA using swollen but not tender joints, whichever endpoint was met first.","['206 male or female subjects from the secondary care hospital setting across the UK and the Netherlands', 'Participants who were at least 18 years old, who reported inflammatory sounding joint pain (clinically suspicious arthralgia) and who were found to be positive for serum autoantibodies associated with rheumatoid arthritis (RA) were eligible for enrolment']","['placebo', 'investigational medicinal product, either abatacept or placebo']","['feasibility, acceptability and effectiveness', 'time to development of at least three swollen joints or to the fulfilment of the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA using swollen but not tender joints']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0337953', 'cui_str': 'Secondary care hospital (environment)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004358', 'cui_str': 'Autoantibodies'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1619966', 'cui_str': 'abatacept'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling (finding)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0035435', 'cui_str': 'Rheumatism'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0234234', 'cui_str': 'Tender (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}]",206.0,0.384286,"The primary endpoint was defined as the time to development of at least three swollen joints or to the fulfilment of the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA using swollen but not tender joints, whichever endpoint was met first.","[{'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Al-Laith', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London, Weston Education Centre, 10 Cutcombe Road, London, SE5 9RJ, UK. mariam.al-laith@kcl.ac.uk.""}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Jasenecova', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London, Weston Education Centre, 10 Cutcombe Road, London, SE5 9RJ, UK.""}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Abraham', 'Affiliation': 'Department of Rheumatology, National Institute for Health Research-Wellcome Clinical Research Facility, Hammersmith Hospital, Imperial College, London, W12 0HS, UK.'}, {'ForeName': 'Aisla', 'Initials': 'A', 'LastName': 'Bosworth', 'Affiliation': 'National RA Society, The Switchback Office Park, Gardner Road, Maidenhead, SL6 7RJ, UK.'}, {'ForeName': 'Ian N', 'Initials': 'IN', 'LastName': 'Bruce', 'Affiliation': 'Arthritis Research UK Centre for Epidemiology, Centre for Musculoskeletal Research, Faculty of Biology, Medicine and Health, Stopford Building, University of Manchester, Oxford Road, Manchester, M13 9PT, UK.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Buckley', 'Affiliation': 'Rheumatology Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Queen Elizabeth Hospital, Birmingham, B15 2WB, UK.'}, {'ForeName': 'Coziana', 'Initials': 'C', 'LastName': 'Ciurtin', 'Affiliation': 'Department of Adolescent and Adult Rheumatology, University College London Hospitals NHS Trust, 3rd Floor Central, 250 Euston Road, London, NW1 2PG, UK.'}, {'ForeName': 'Maria-Antonietta', 'Initials': 'MA', 'LastName': ""D'Agostino"", 'Affiliation': 'Rheumatology Department, Hôpital Ambroise Paré, 92100, Boulogne-Billancourt, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Section of Musculoskeletal Disease, Leeds Institute of Molecular Medicine, University of Leeds, UK NIHR Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, LS4 7SA, UK.'}, {'ForeName': 'Hill', 'Initials': 'H', 'LastName': 'Gaston', 'Affiliation': 'Department of Medicine, University of Cambridge and Addenbrookes Hospital NHS Trust, Cambridge, UK.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Isaacs', 'Affiliation': 'Musculoskeletal Research Group, Institute of Cellular Medicine, Newcastle University, 3rd Floor William Leech Building, The Medical School, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Filer', 'Affiliation': 'Rheumatology Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Queen Elizabeth Hospital, Birmingham, B15 2WB, UK.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Fisher', 'Affiliation': 'Rheumatology Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Queen Elizabeth Hospital, Birmingham, B15 2WB, UK.'}, {'ForeName': 'Thomas W J', 'Initials': 'TWJ', 'LastName': 'Huizinga', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Ho', 'Affiliation': 'Arthritis Research UK Centre for Epidemiology, Centre for Musculoskeletal Research, Faculty of Biology, Medicine and Health, Stopford Building, University of Manchester, Oxford Road, Manchester, M13 9PT, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Jacklin', 'Affiliation': 'National RA Society, The Switchback Office Park, Gardner Road, Maidenhead, SL6 7RJ, UK.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Lempp', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London, Weston Education Centre, 10 Cutcombe Road, London, SE5 9RJ, UK.""}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, 120 University Place, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Arthur G', 'Initials': 'AG', 'LastName': 'Pratt', 'Affiliation': 'Musculoskeletal Research Group, Institute of Cellular Medicine, Newcastle University, 3rd Floor William Leech Building, The Medical School, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Östor', 'Affiliation': 'Department of Medicine, University of Cambridge and Addenbrookes Hospital NHS Trust, Cambridge, UK.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Raza', 'Affiliation': 'Rheumatology Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Queen Elizabeth Hospital, Birmingham, B15 2WB, UK.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Taylor', 'Affiliation': 'Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Windmill Road, Headington, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Dirkjan', 'Initials': 'D', 'LastName': 'van Schaardenburg', 'Affiliation': 'Amsterdam Rheumatology and immunology Center, locations Reade and Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Dharshene', 'Initials': 'D', 'LastName': 'Shivapatham', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London, Weston Education Centre, 10 Cutcombe Road, London, SE5 9RJ, UK.""}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Wright', 'Affiliation': 'Clinical, Education & Health Psychology Division of Psychology & Language Sciences, Faculty of Brain Sciences, University College London, London, WC1E 6BT, UK.'}, {'ForeName': 'Joana C', 'Initials': 'JC', 'LastName': 'Vasconcelos', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': ""King's Clinical Trials Unit, King's College London, Institute of Psychiatry, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Murphy', 'Affiliation': ""King's Clinical Trials Unit, King's College London, Institute of Psychiatry, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'A Toby', 'Initials': 'AT', 'LastName': 'Prevost', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Cope', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London, Weston Education Centre, 10 Cutcombe Road, London, SE5 9RJ, UK. andrew.cope@kcl.ac.uk.""}]",Trials,['10.1186/s13063-019-3403-7']
3049,31994173,Multimedia in improving informed consent for caesarean section: A randomised controlled trial.,"BACKGROUND


Multimedia modules have been used as an adjunct to improve patient knowledge and recall for various elective surgical procedures, but have been incompletely evaluated in patients undergoing caesarean section.
AIMS


To compare the use of a supplementary multimedia module with written information in improving the informed consent process prior to elective caesarean section.
MATERIALS AND METHODS


This was a prospective randomised controlled trial (ACTRN12616000430437). Primary outcomes were knowledge and anxiety scores immediately following the intervention and on the day of surgery. Secondary outcomes were patient satisfaction, length of stay, time to cessation of analgesia, and patient assessment of the consent types.
RESULTS


Seventy-five patients completed the study. Both multimedia module and written information groups demonstrated a significant increase in knowledge scores with no difference between the groups. In the multimedia-assisted consent group, scores improved from baseline by +2.31 (P < 0.001) immediately after watching the multimedia module and by +2.41 (P < 0.001) on the day of surgery. In the written information group, scores improved by +1.76 (P < <0.001), and +2.31 (P < 0.001) respectively. There was no adverse impact on anxiety in either group. Patient-reported understanding (92.4% vs 78.5%, P = 0.001), and helpfulness (90.1% vs 73.3%, P = 0.001) was significantly higher in the multimedia module group than in the written information group. The multimedia module was assessed as 'slightly too long' and provided 'slightly too much information'.
CONCLUSIONS


Multimedia modules are a valuable adjunct to traditional processes of obtaining informed consent for elective caesarean section and should be offered and made available to patients prior to surgery.",2020,"In the multimedia-assisted consent group, scores improved from baseline by +2.31 (P < 0.001) immediately after watching the multimedia module and by +2.41 (P < 0.001) on the day of surgery.","['Seventy-five patients completed the study', 'patients undergoing caesarean section', 'caesarean section']",['supplementary multimedia module with written information'],"['knowledge and anxiety scores', 'patient satisfaction, length of stay, time to cessation of analgesia, and patient assessment of the consent types', 'anxiety', 'knowledge scores']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]",75.0,0.0678778,"In the multimedia-assisted consent group, scores improved from baseline by +2.31 (P < 0.001) immediately after watching the multimedia module and by +2.41 (P < 0.001) on the day of surgery.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Truong', 'Affiliation': 'Mercy Perinatal, Mercy Hospital for Women, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lenore', 'Initials': 'L', 'LastName': 'Ellett', 'Affiliation': 'Mercy Perinatal, Mercy Hospital for Women, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hicks', 'Affiliation': 'Mercy Perinatal, Mercy Hospital for Women, Melbourne, Victoria, Australia.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Pell', 'Affiliation': 'Mercy Perinatal, Mercy Hospital for Women, Melbourne, Victoria, Australia.'}, {'ForeName': 'Susan P', 'Initials': 'SP', 'LastName': 'Walker', 'Affiliation': 'Mercy Perinatal, Mercy Hospital for Women, Melbourne, Victoria, Australia.'}]",The Australian & New Zealand journal of obstetrics & gynaecology,['10.1111/ajo.13124']
3050,31997578,Efficiency of a radiofrequency sealer (Aquamantys) for parenchymal transection during laparoscopic hepatectomy.,"INTRODUCTION


The methods of liver parenchymal transection vary across institutions. In this study, we used a radiofrequency (RF) sealer (Aquamantys) as a hemostatic device during laparoscopic liver transection; we also evaluated the usefulness of RF sealers.
METHODS


From April 2016 to May 2019, 113 consecutive laparoscopic hepatectomy patients, excluding patients with combined resection of other organs, were examined. Patient characteristics, operative factors, and postoperative complications were compared between the Cavitron ultrasonic surgical aspirator (CUSA) + soft coagulation system (VIO) group; (n = 32) and the CUSA + Aquamantys group; (n = 81). The former underwent liver transection by CUSA and VIO from April 2016 to March 2017, while the latter underwent liver transection using CUSA and Aquamantys from April 2017 to May 2019.
RESULTS


The median difficulty score was significantly higher in the CUSA + VIO group (5.5 points vs 5.0 points; P = .04). Blood loss per unit area and the liver parenchymal transection speed were not significantly different between the groups. After propensity score matching, blood loss per unit area was similar between the groups, but the parenchymal transection speed of the CUSA + Aquamantys group was significantly higher (0.92 cm 2  /min vs 0.64 cm 2  /min; P = .017). Postoperative complications were similar between the groups.
CONCLUSION


In laparoscopic hepatectomy, hemostasis of the transection plane with an RF sealer did not reduce blood loss during parenchymal transection. However, the liver parenchymal transection speed was increased.",2020,"In laparoscopic hepatectomy, hemostasis of the transection plane with an RF sealer did not reduce blood loss during parenchymal transection.","['parenchymal transection during laparoscopic hepatectomy', 'From April 2016 to May 2019, 113 consecutive laparoscopic hepatectomy patients, excluding patients with combined resection of other organs, were examined', 'laparoscopic liver transection']","['Cavitron ultrasonic surgical aspirator (CUSA)\u2009+\u2009soft coagulation system', 'radiofrequency (RF) sealer (Aquamantys', 'RF sealer', 'radiofrequency sealer (Aquamantys']","['parenchymal transection speed of the CUSA', 'Blood loss per unit area and the liver parenchymal transection speed', 'Postoperative complications', 'Patient characteristics, operative factors, and postoperative complications', 'blood loss', 'blood loss per unit area', 'liver parenchymal transection speed', 'median difficulty score']","[{'cui': 'C0152060', 'cui_str': 'Transection (procedure)'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0023884', 'cui_str': 'Liver'}]","[{'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0042226', 'cui_str': 'Aspirator, device (physical object)'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0449942', 'cui_str': 'Sealer (attribute)'}]","[{'cui': 'C0152060', 'cui_str': 'Transection (procedure)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0280195,"In laparoscopic hepatectomy, hemostasis of the transection plane with an RF sealer did not reduce blood loss during parenchymal transection.","[{'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Iida', 'Affiliation': 'Department of Surgery, Shiga University of Medical Science, Seta Tsukinowa-Cho, Otsu, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Maehira', 'Affiliation': 'Department of Surgery, Shiga University of Medical Science, Seta Tsukinowa-Cho, Otsu, Japan.'}, {'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Mori', 'Affiliation': 'Department of Surgery, Shiga University of Medical Science, Seta Tsukinowa-Cho, Otsu, Japan.'}, {'ForeName': 'Masaji', 'Initials': 'M', 'LastName': 'Tani', 'Affiliation': 'Department of Surgery, Shiga University of Medical Science, Seta Tsukinowa-Cho, Otsu, Japan.'}]",Asian journal of endoscopic surgery,['10.1111/ases.12785']
3051,30903540,"The Effect of an Intervention Teaching Adolescents that People can Change on Depressive Symptoms, Cognitive Schemas, and Hypothalamic-Pituitary-Adrenal Axis Hormones.","Interest is increasing in developing universal interventions to prevent depression in adolescents that are brief enough to be scaled up. The aim of this study was to test the effects on depressive symptoms, cognitive schemas, and Hypothalamic-Pituitary-Adrenal Axis Hormones of an intervention focused on teaching an element of an incremental theory of personality, namely, the belief that people can change. We also examined whether grade level moderated the effects of the intervention. A double-blind, randomized, controlled trial was conducted with 867 Spanish adolescent participants (51.9% boys, Grades 8-10) randomly assigned to an incremental theory intervention (n = 456) or an educational control intervention (n = 411). The adolescents completed measures of depressive symptoms and negative cognitive schemas at pretest, at 6-month follow-up, and at 12-month follow-up. A subsample of 503 adolescents provided salivary samples for cortisol and DHEA-S testing. In 8th grade, adolescents who received the incremental theory intervention displayed a greater decrease in depressive symptoms and cognitive schemas and a lower increase in DHEA-S. Moreover, in adolescents who received the intervention, the rate of adolescents with high depression scores decreased by almost 18% whereas in the control group, the rate increased by 37%. Surprisingly, the effects of the intervention were in the opposite direction among adolescents in 9th grade. These data indicate that a brief universal intervention could prevent depressive symptoms under some conditions, but developmental characteristics can moderate the effectiveness of this approach.",2019,"In 8th grade, adolescents who received the incremental theory intervention displayed a greater decrease in depressive symptoms and cognitive schemas and a lower increase in DHEA-S.","['867 Spanish adolescent participants (51.9% boys, Grades 8-10) randomly assigned to an', '503 adolescents provided salivary samples for cortisol and DHEA-S testing']",['incremental theory intervention (n\u2009=\u2009456) or an educational control intervention'],"['depressive symptoms and negative cognitive schemas', 'DHEA-S', 'rate of adolescents with high depression scores', 'depressive symptoms', 'depressive symptoms and cognitive schemas', 'Depressive Symptoms, Cognitive Schemas, and Hypothalamic-Pituitary-Adrenal Axis Hormones']","[{'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}]",867.0,0.0384538,"In 8th grade, adolescents who received the incremental theory intervention displayed a greater decrease in depressive symptoms and cognitive schemas and a lower increase in DHEA-S.","[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Calvete', 'Affiliation': 'Department of Personality, Psychological Assessment and Treatment, University of Deusto, Avenida de las Universidades, 24, 48007, Bilbao, Spain. esther.calvete@deusto.es.'}, {'ForeName': 'Liria', 'Initials': 'L', 'LastName': 'Fernández-Gonzalez', 'Affiliation': 'Department of Personality, Psychological Assessment and Treatment, University of Deusto, Avenida de las Universidades, 24, 48007, Bilbao, Spain.'}, {'ForeName': 'Izaskun', 'Initials': 'I', 'LastName': 'Orue', 'Affiliation': 'Department of Personality, Psychological Assessment and Treatment, University of Deusto, Avenida de las Universidades, 24, 48007, Bilbao, Spain.'}, {'ForeName': 'Ainara', 'Initials': 'A', 'LastName': 'Echezarraga', 'Affiliation': 'Department of Personality, Psychological Assessment and Treatment, University of Deusto, Avenida de las Universidades, 24, 48007, Bilbao, Spain.'}, {'ForeName': 'Estibaliz', 'Initials': 'E', 'LastName': 'Royuela-Colomer', 'Affiliation': 'Department of Personality, Psychological Assessment and Treatment, University of Deusto, Avenida de las Universidades, 24, 48007, Bilbao, Spain.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Cortazar', 'Affiliation': 'Department of Personality, Psychological Assessment and Treatment, University of Deusto, Avenida de las Universidades, 24, 48007, Bilbao, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Muga', 'Affiliation': 'IMQanalisis, 48008, Bilbao, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Longa', 'Affiliation': 'IMQanalisis, 48008, Bilbao, Spain.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Yeager', 'Affiliation': 'University of Texas, Austin, TX, 78712, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-019-00538-1']
3052,31832912,Varying Effect of a Randomized Toddler Home Safety Promotion Intervention Trial by Initial Home Safety Problems.,"OBJECTIVES


Toddlers are vulnerable to unintentional injuries. A safety intervention targeting low-income families of toddlers, was effective at improving home safety. The current study examined whether the effect varies by initial home safety problems.
METHODS


277 mother-toddler dyads recruited in the Mid-Atlantic region of the United States during 2007-2010 were randomized into safety promotion (n = 91) or attention-control groups (n = 186). Observers rated participants' homes with a 9-item safety problem checklist at baseline, and at 6- and 12-months follow-up. Initial home safety problems were categorized as multiple (≥ 4 problems) and none/few (< 4). Linear mixed models assessed the moderating effect with a three-way interaction (time, intervention, and initial safety problems).
RESULTS


At 12 months, the intervention effect was stronger among families with multiple initial problems than no/few initial problems, with a reduction of 1.55 more problems among the families with multiple problems, compared to the families with no/few problems (b = - 1.55, SE = 0.62, p = 0.013).
CONCLUSIONS


Interventions targeting families with multiple safety problems may be more effective than universal programming.",2020,"At 12 months, the intervention effect was stronger among families with multiple initial problems than no/few initial problems, with a reduction of 1.55 more problems among the families with multiple problems, compared to the families with no/few problems (b = - 1.55, SE = 0.62, p = 0.013).
","['277 mother-toddler dyads recruited in the\xa0Mid-Atlantic region\xa0of the United\xa0States during 2007-2010 were randomized into', ""Observers rated participants' homes with a""]",['safety promotion (n\u2009=\u200991) or attention-control groups'],['9-item safety problem checklist'],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0026053', 'cui_str': 'Middle Atlantic States'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",,0.037765,"At 12 months, the intervention effect was stronger among families with multiple initial problems than no/few initial problems, with a reduction of 1.55 more problems among the families with multiple problems, compared to the families with no/few problems (b = - 1.55, SE = 0.62, p = 0.013).
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, 737\xa0W. Lombard Street, Baltimore, MD, 21201, USA. yan.wang@som.umaryland.edu.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Gielen', 'Affiliation': 'Department of Health, Behaviour and Society, Johns Hopkins Centre for Injury Research and Policy, Johns Hopkins Bloomberg School of Public Health, 624\xa0N. Broadway, Hampton House 554, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Laurence S', 'Initials': 'LS', 'LastName': 'Magder', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Howard Hall Building, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Hager', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, 737\xa0W. Lombard Street, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Black', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, 737\xa0W. Lombard Street, Baltimore, MD, 21201, USA.'}]",Maternal and child health journal,['10.1007/s10995-019-02845-x']
3053,30219843,Human Immunodeficiency Virus-associated Neurocognitive Impairment in Diverse Resource-limited Settings.,"BACKGROUND


Neurocognitive impairment remains a common complication of human immunodeficiency virus (HIV) despite effective antiretroviral therapy (ART). We previously reported improved neurocognitive functioning with ART initiation in 7 resource-limited countries for HIV+ participants from the AIDS Clinical Trials Group (ACTG) 5199 International Neurological Study (INS). Here, we apply normative data from the International Neurocognitive Normative Study (INNS) to INS to provide previously unknown rates of neurocognitive impairment.
METHODS


The A5199 INS assessed neurocognitive and neurological performance within a randomized clinical trial with 3 arms containing World Health Organization first-line recommended ART regimens (ACTG 5175; PEARLS). The ACTG 5271 INNS collected normative comparison data on 2400 high-risk HIV-negative participants from 10 voluntary counseling and testing sites aligned with INS. Normative comparison data were used to create impairment ratings for HIV+ participants in INS; associations were estimated using generalized estimating equations.
RESULTS


Among 860 HIV+ adults enrolled in ACTG 5199, 55% had no neurocognitive impairment at baseline. Mild neurocognitive impairment was found in 25%, moderate in 17%, and severe in 3% of participants. With the initiation of ART, the estimated odds of impairment were reduced 12% (95% confidence interval, 9%, 14%) for every 24 weeks (P < .0001) on ART. Mild impairment dropped slightly and then remained at about 18% out to week 168.
CONCLUSIONS


Almost half of HIV+ participants had neurocognitive impairment at baseline before ART, based on local norms. With ART initiation, there were significant overall reductions in neurocognitive impairment over time, especially in those with moderate and severe impairments.
CLINICAL TRIALS REGISTRATION


NCT00096824.",2019,"With the initiation of ART, the estimated odds of impairment was reduced 12% (95% CI: 9%, 14%) for every 24 weeks (p<.0001) on ART.","['860 HIV+ adults enrolled in ACTG 5199, 55% had no neurocognitive impairment at baseline', 'HIV+ participants from AIDS Clinical Trials Group (ACTG) 5199 (International Neurological Study (INS']",[],"['neurocognitive and neurological performance', 'Mild neurocognitive impairment', 'Mild impairment', 'neurocognitive impairment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1320290', 'cui_str': 'Clinical trial group'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",,0.664029,"With the initiation of ART, the estimated odds of impairment was reduced 12% (95% CI: 9%, 14%) for every 24 weeks (p<.0001) on ART.","[{'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Robertson', 'Affiliation': 'University of North Carolina, Chapel Hill, Massachusetts.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Harvard Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Johnstone', 'Initials': 'J', 'LastName': 'Kumwenda', 'Affiliation': 'Queen Elizabeth College of Medicine-Johns Hopkins Project, Blantyre, Malawi.'}, {'ForeName': 'Khuanchai', 'Initials': 'K', 'LastName': 'Supparatpinyo', 'Affiliation': 'Chiang Mai University, Thailand.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Marra', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Baiba', 'Initials': 'B', 'LastName': 'Berzins', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hakim', 'Affiliation': 'University of Zimbabwe, Harare.'}, {'ForeName': 'Ned', 'Initials': 'N', 'LastName': 'Sacktor', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Campbell', 'Affiliation': 'University of Colorado Health Sciences Center, Denver.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Schouten', 'Affiliation': 'Fred Hutchinson Cancer Center and University of Washington, Seattle.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Mollan', 'Affiliation': 'University of North Carolina, Chapel Hill, Massachusetts.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Tripathy', 'Affiliation': 'National AIDS Research Institute, Pune, India.'}, {'ForeName': 'Nagalingeswaran', 'Initials': 'N', 'LastName': 'Kumarasamy', 'Affiliation': 'Gaitonde Centre for AIDS Research and Education, Chennai, India.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'La Rosa', 'Affiliation': 'Asociacion Civil Impacta Salud y Educacion, Lima, Peru.'}, {'ForeName': 'Breno', 'Initials': 'B', 'LastName': 'Santos', 'Affiliation': 'Hospital Conceicao, Porto Alegre, Brazil.'}, {'ForeName': 'Marcus T', 'Initials': 'MT', 'LastName': 'Silva', 'Affiliation': 'Fiocruz, Rio De Janeiro, Brazil.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Kanyama', 'Affiliation': 'UNC Project-Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Firhnhaber', 'Affiliation': 'University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Murphy', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Hall', 'Affiliation': 'University of North Carolina, Chapel Hill, Massachusetts.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Marcus', 'Affiliation': 'University of North Carolina, Chapel Hill, Massachusetts.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Naini', 'Affiliation': 'Social Scientific Systems, Silver Springs, Maryland.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Masih', 'Affiliation': 'Social Scientific Systems, Silver Springs, Maryland.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'University of North Carolina, Chapel Hill, Massachusetts.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Mngqibisa', 'Affiliation': 'Durban International CRS, South Africa.'}, {'ForeName': 'Sharlaa', 'Initials': 'S', 'LastName': 'Badal-Faesen', 'Affiliation': 'University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Yosief', 'Affiliation': 'University of North Carolina, Chapel Hill, Massachusetts.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Vecchio', 'Affiliation': 'Universita Vita - Salute San Raffaele, Milan, Italy.'}, {'ForeName': 'Apsara', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'Frontier Science & Technology Research Foundation, Buffalo, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy767']
3054,31970830,Effects of hospital-family holistic care model on the health outcome of patients with permanent enterostomy based on the theory of 'Timing It Right'.,"AIMS AND OBJECTIVES


To explore the effects of hospital-family holistic care model based on 'Timing It Right' on the health outcome of patients with permanent colostomy.
BACKGROUND


Colorectal cancer is a common malignant tumour of digestive system, which seriously threatens human life and health. Colostomy is one of the main treatments for colorectal cancer, which effectively improves the 5-year survival rate of patients. However, the postoperative psychological and physiological rehabilitation nursing is still faced with great challenges due to the change of body image and defecation pathway caused by colostomy.
METHODS


A randomised controlled trial was conducted, and 119 patients with permanent enterostomy were randomly divided into two groups, with 60 cases in the intervention group and 59 cases in the control group. The intervention group received routine care follow-up and hospital-family holistic care intervention based on 'Timing It Right', while the control group received routine care and follow-up. The resilience, self-care ability, complications and life quality of patients with permanent enterostomy were compared between two groups before intervention, at discharge, 3 months and 6 months after discharge. CONSORT checklist was applied as the reporting guideline for this study (see Appendix S1).
RESULTS


A total of 108 patients with permanent enterostomy completed the study (90.76%). At 3 months and 6 months after discharge, the resilience and quality of life in the intervention group were significantly better than those in the control group (t = 4.158 vs. 7.406, t = 4.933 vs. 8.611, p < .05), while the complications in the intervention group were significantly lower than that in the control group (25.5% vs. 41.51%, 14.45% vs. 30.19%; p < .05). The self-care ability of the intervention group was significantly better than that in the control group (t = 1.543 vs. 3.656 vs. 6.273, p < .05) at discharge, 3 months and 6 months after discharge. The interaction between time and grouping showed that the effect of time factor varied with the grouping. After intervention, there were significant differences in psychological resilience, self-care ability, complications and quality of life between the two groups at different observation points (p < .01). The three evaluation indices of intervention group increased with the migration of observation time points and were significantly better than those of control group, especially the quality of life (84.35 ± 4.25 vs. 60.45 ± 8.42, p < .01).
CONCLUSIONS


The hospital-family holistic care model based on 'Timing It Right' can effectively improve the psychological resilience, self-care ability and quality of life; reduce complications; and improve the health outcomes of patients with permanent enterostomy.
RELEVANCE TO CLINICAL PRACTICE


Patients with permanent enterostomy have different needs for nursing care at different stages of the disease, and they are dynamically changing. The hospital-family holistic care model based on 'Timing It Right' can effectively improve the health outcomes of patients with permanent enterostomy, which is worthy of clinical application.",2020,"The three evaluation indices of intervention group increased with the migration of observation time points and were significantly better than those of control group, especially the quality of life (84.35±4.25 vs 60.45±8.42, P < 0.01).
","['Patients with permanent colostomy', '108 patients with permanent enterostomy completed the study (90.76', 'patients with permanent enterostomy', 'Patients with permanent enterostomy based on the theory of ""Timing It Right', '119 patients with permanent enterostomy']","['hospital-family holistic care model', 'routine care、follow-up and hospital-family holistic care intervention based on ""Timing It Right"", while the control group received routine care and follow-up']","['5-year survival rate', 'resilience and quality of life', 'quality of life', 'psychological resilience, self-care ability, quality of life, reduce complications', 'resilience, self-care ability, complications and life quality', 'health outcomes', 'psychological resilience、 self-care ability、complications and quality of life', 'self-care ability', 'migration of observation time points']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0192973', 'cui_str': 'Permanent colostomy (procedure)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C1442523', 'cui_str': 'Enterostomy (morphologic abnormality)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0034380'}, {'cui': 'C0683253', 'cui_str': 'Psychological Resiliences'}, {'cui': 'C0562734', 'cui_str': 'Ability to perform self-care activities'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",119.0,0.0286812,"The three evaluation indices of intervention group increased with the migration of observation time points and were significantly better than those of control group, especially the quality of life (84.35±4.25 vs 60.45±8.42, P < 0.01).
","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Nursing, Fujian Provincial Hospital, Fujian Medical University Affiliated Clinical Provincial Medical Institute, Fuzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Department of Pathology, Fujian Provincial Hospital, Fujian Medical University Affiliated Clinical Provincial Medical Institute, Fuzhou, China.'}, {'ForeName': 'Jin Ling', 'Initials': 'JL', 'LastName': 'Lin', 'Affiliation': 'Nursing School of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Fujian Provincial Hospital, Fujian Medical University Affiliated Clinical Provincial Medical Institute, Fuzhou, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, Fujian Provincial Hospital, Fujian Medical University Affiliated Clinical Provincial Medical Institute, Fuzhou, China.'}, {'ForeName': 'Gui Fang', 'Initials': 'GF', 'LastName': 'Huang', 'Affiliation': 'Department of Nursing, Fujian Provincial Hospital, Fujian Medical University Affiliated Clinical Provincial Medical Institute, Fuzhou, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, Fujian Provincial Hospital, Fujian Medical University Affiliated Clinical Provincial Medical Institute, Fuzhou, China.'}, {'ForeName': 'Xiao Huan', 'Initials': 'XH', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Fujian Provincial Hospital, Fujian Medical University Affiliated Clinical Provincial Medical Institute, Fuzhou, China.'}, {'ForeName': 'Fang Qin', 'Initials': 'FQ', 'LastName': 'Xue', 'Affiliation': 'Department of Gastroenterology, Fujian Provincial Hospital, Fujian Medical University Affiliated Clinical Provincial Medical Institute, Fuzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Nursing, Fujian Provincial Hospital, Fujian Medical University Affiliated Clinical Provincial Medical Institute, Fuzhou, China.'}]",Journal of clinical nursing,['10.1111/jocn.15199']
3055,31816909,Differential Effects of Monounsaturated and Polyunsaturated Fats on Satiety and Gut Hormone Responses in Healthy Subjects.,"The difference between fat saturation on postprandial hormone responses and acute appetite control is not well understood. The aim of this study was to compare the postprandial ghrelin, gastric inhibitory polypeptide (GIP) and glucagon-like peptide-1 (GLP1) response and subjective appetite responses after isoenergetic high-fat meals rich in either monounsaturated (MUFAs) or polyunsaturated fatty acids (PUFAs) in healthy Chinese males. A randomized, controlled, single-blinded crossover study was conducted in 13 healthy Chinese men. Two high-fat meals (64% of energy) rich in MUFAs or PUFAs were tested. Total ghrelin, GIP and active GLP1 and visual analog scale (VAS) were measured over 4 h. Ghrelin was reduced greater after MUFA compared to PUFA at the beginning of the meal (at 30 and 60 min) and was significantly negatively correlated with subjective VAS for preoccupation for both MUFA and PUFA meals. No significant difference for ghrelin 240 min incremental area under the curve (iAUCs) were found. MUFA induced higher GIP response than PUFA. GIP was associated with all the VAS measurements except preoccupation for MUFA meal. No difference was found for GLP1 between two meals, nor was GLP1 associated with VAS. In conclusion, the results demonstrate that ghrelin, GIP and VAS respond differently to MUFA and PUFA meals. Ghrelin and GIP, but not GLP1, were associated with acute appetite control, especially after MUFA meal.",2019,Ghrelin was reduced greater after MUFA compared to PUFA at the beginning of the meal (at 30 and 60 min) and was significantly negatively correlated with subjective VAS for preoccupation for both MUFA and PUFA meals.,"['Healthy Subjects', '13 healthy Chinese men', 'healthy Chinese males']","['polyunsaturated fatty acids (PUFAs', 'MUFA', 'Monounsaturated and Polyunsaturated Fats']","['ghrelin 240 min incremental area under the curve (iAUCs', 'postprandial hormone responses', 'Satiety and Gut Hormone Responses', 'Total ghrelin, GIP and active GLP1 and visual analog scale (VAS', 'GLP1', 'GIP response', 'postprandial ghrelin, gastric inhibitory polypeptide (GIP) and glucagon-like peptide-1 (GLP1) response and subjective appetite responses', 'Ghrelin']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C2362518', 'cui_str': 'Polyunsaturated fat (substance)'}]","[{'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0017132', 'cui_str': 'Glucose-Dependent Insulin-Releasing Peptide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}]",13.0,0.0258109,Ghrelin was reduced greater after MUFA compared to PUFA at the beginning of the meal (at 30 and 60 min) and was significantly negatively correlated with subjective VAS for preoccupation for both MUFA and PUFA meals.,"[{'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute for Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR), 30 Medical Drive, Singapore 117609, Singapore.'}, {'ForeName': 'Hui Jen', 'Initials': 'HJ', 'LastName': 'Goh', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute for Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR), 30 Medical Drive, Singapore 117609, Singapore.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Govindharajulu', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute for Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR), 30 Medical Drive, Singapore 117609, Singapore.'}, {'ForeName': 'Melvin Khee-Shing', 'Initials': 'MK', 'LastName': 'Leow', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute for Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR), 30 Medical Drive, Singapore 117609, Singapore.'}, {'ForeName': 'Christiani Jeyakumar', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute for Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR), 30 Medical Drive, Singapore 117609, Singapore.'}]","Foods (Basel, Switzerland)",['10.3390/foods8120634']
3056,32151044,"Standing Meetings Are Feasible and Effective in Reducing Sitting Time among Office Workers-Walking Meetings Are Not: Mixed-Methods Results on the Feasibility and Effectiveness of Active Meetings Based on Data from the ""Take a Stand!"" Study.","Active meetings (standing or walking) have the potential to reduce sitting time among office workers. The aim of the present study was to explore the feasibility and effectiveness of standing and walking meetings. The ""Take a Stand!"" study was a cluster-randomized trial, consisting of multiple components including the possibility of active meetings. Analyses were based on the 173 participants in the intervention group. Feasibility was evaluated by questionnaire and interview data from participants, ambassadors and leaders. Effectiveness was assessed as the change in objectively measured sitting time from baseline to 3 months follow-up. Regular standing meetings were implemented at all offices and were generally popular, as they were perceived as more effective and focused. In contrast, only a few walking meetings were completed, and these were generally associated with several barriers and perceived as ineffective. Participants who participated in standing meetings on a regular basis had 59 min less sitting per 8 h workday (95%CI -101;-17) compared to participants who did not participate in standing meetings at all. Walking meeting participation was not significantly associated with changes in sitting time, likely due to the low number of employees who used this option. This explorative study concludes that standing meetings in office workplaces were feasible and well-liked by the employees, and having frequent standing meetings was associated with reduced sitting time. In contrast, walking meetings were unfeasible and less liked, and thus had no effect on sitting time.",2020,"This explorative study concludes that standing meetings in office workplaces were feasible and well-liked by the employees, and having frequent standing meetings was associated with reduced sitting time.","['Office Workers-Walking Meetings', '173 participants in the intervention group', 'Participants who participated in standing meetings on a regular basis had 59 min less sitting per 8 h workday (95%CI -101;-17) compared to participants who did not participate in standing meetings at all']","['standing and walking meetings', 'Active meetings (standing or walking']",['sitting time'],"[{'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",173.0,0.0320721,"This explorative study concludes that standing meetings in office workplaces were feasible and well-liked by the employees, and having frequent standing meetings was associated with reduced sitting time.","[{'ForeName': 'Ida H', 'Initials': 'IH', 'LastName': 'Danquah', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, 1455 Copenhagen, Denmark.'}, {'ForeName': 'Janne S', 'Initials': 'JS', 'LastName': 'Tolstrup', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, 1455 Copenhagen, Denmark.'}]",International journal of environmental research and public health,['10.3390/ijerph17051713']
3057,31949115,Gefapixant in two randomised dose-escalation studies in chronic cough.,"BACKGROUND AND OBJECTIVES


Gefapixant has previously demonstrated efficacy in the treatment of refractory chronic cough at a high daily dose. The current investigations explore efficacy and tolerability of gefapixant, a P2X3 receptor antagonist, for the treatment of chronic cough using a dose-escalation approach.
MATERIALS AND METHODS


Two randomised, double-blind, placebo-controlled, crossover, dose-escalation studies recruited participants with refractory chronic cough. Patients were assigned to receive ascending doses of gefapixant (study 1: 50-200 mg, study 2: 7.5-50 mg) or placebo for 16 days, then crossed-over after washout. The primary end-point was awake cough frequency assessed using a 24-h ambulatory cough monitor at baseline and on day 4 of each dose. Patient-reported outcomes included a cough severity visual analogue scale and the cough severity diary.
RESULTS


In clinical studies, gefapixant doses ≥30 mg produced maximal improvements in cough frequency compared with placebo (p<0.05); reported cough severity measures improved at similar doses. Taste disturbance exhibited a different relationship with dose, apparently maximal at doses ≥150 mg.
CONCLUSIONS


P2X3 antagonism with gefapixant demonstrates anti-tussive efficacy and improved tolerability at lower doses than previously investigated. Studies of longer duration are warranted.",2020,"In clinical studies, gefapixant doses ≥30 mg produced maximal improvements in cough frequency compared with placebo (p<0.05); reported cough severity measures improved at similar doses.","['participants with refractory chronic cough', 'chronic cough']","['placebo', 'gefapixant']","['cough frequency', 'tolerability', 'cough severity visual analogue scale (VAS) and Cough Severity Diary (CSD', 'awake cough frequency assessed using a 24\u2005h ambulatory cough monitor', 'cough severity measures']","[{'cui': 'C4552486', 'cui_str': 'Refractory chronic cough'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.306416,"In clinical studies, gefapixant doses ≥30 mg produced maximal improvements in cough frequency compared with placebo (p<0.05); reported cough severity measures improved at similar doses.","[{'ForeName': 'Jaclyn A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'University of Manchester and Manchester Academic Health Science Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Kitt', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Butera', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Smith', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA jacky.smith@manchester.ac.uk.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'GetStat Solutions, LLC, Palo Alto, CA, USA.'}, {'ForeName': 'Zhi Jin', 'Initials': 'ZJ', 'LastName': 'Xu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Holt', 'Affiliation': 'University of Manchester and Manchester Academic Health Science Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Shilpi', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'University of Manchester and Manchester Academic Health Science Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Mandel R', 'Initials': 'MR', 'LastName': 'Sher', 'Affiliation': 'Center for Cough, Largo, FL, USA.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Ford', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}]",The European respiratory journal,['10.1183/13993003.01615-2019']
3058,31991566,Effects of Immunonutrition on Comprehensive Complication Index in Patients Undergoing Pancreatoduodenectomy.,"Background and objectives:  Immunonutrition is recommended by enhanced recovery after surgery in patients undergoing pancreatoduodenectomy for 5-7 days perioperatively as it may reduce the rate of infectious complications. However, data on effect of immunonutrition on the overall complication rate are contradictory and it is not clear, which groups of patients benefit most. The aims of this study are to evaluate the effects of immunonutrition on the overall complication rate and the rate of severe and/or multiple complications in patients with pancreatic tumours stratified according to final histological diagnosis-patients with pancreatic ductal adenocarcinoma (PDAC) vs. other tumours-and nutritional state, using more sensitive Comprehensive Complication Index.  Materials and Methods:  Seventy consecutive patients scheduled for pancreatoduodenectomy because of pancreatic tumours were randomised into immunonutrition vs. control groups and stratified according to final histological diagnosis and nutritional status. Surgical outcomes were assessed postoperatively using Clavien-Dindo classification (CDC) and Comprehensive Complication Index (CCI).  Results:  No significant differences in the overall complication rates in immunonutrition vs. control, patients with malnutrition vs. no malnutrition, PDAC vs. other pancreatic tumours groups were detected. However, significant differences in the rates of severe and/or multiple complications in immunonutrition vs. control groups and in PDAC patients segregated according to immunonutrition were obtained using CCI.  Conclusions:  Patients with PDAC may experience greater benefits of immunonutrition as compared to patients with benign pancreatic diseases or less aggressive tumours, while nutritional status was not a determining factor for the efficacy of immunonutrition.",2020,"However, significant differences in the rates of severe and/or multiple complications in immunonutrition vs. control groups and in PDAC patients segregated according to immunonutrition were obtained using CCI.  ","['Seventy consecutive patients scheduled for pancreatoduodenectomy because of pancreatic tumours', 'Patients Undergoing Pancreatoduodenectomy', 'patients undergoing', 'patients with pancreatic tumours stratified according to final histological diagnosis-patients with pancreatic ductal adenocarcinoma (PDAC) vs. other tumours-and nutritional state']","['Immunonutrition', 'pancreatoduodenectomy', 'immunonutrition']","['overall complication rates', 'Comprehensive Complication Index', 'Clavien-Dindo classification (CDC) and Comprehensive Complication Index (CCI', 'overall complication rate', 'rates of severe and/or multiple complications']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}]",70.0,0.0297389,"However, significant differences in the rates of severe and/or multiple complications in immunonutrition vs. control groups and in PDAC patients segregated according to immunonutrition were obtained using CCI.  ","[{'ForeName': 'Jaroslav', 'Initials': 'J', 'LastName': 'Tumas', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, 03101 Vilnius, Lithuania.'}, {'ForeName': 'Eugenijus', 'Initials': 'E', 'LastName': 'Jasiūnas', 'Affiliation': 'Centre of Informatics and Development, Vilnius University Hospital Santaros Klinikos, 08406 Vilnius, Lithuania.'}, {'ForeName': 'Kęstutis', 'Initials': 'K', 'LastName': 'Strupas', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, 03101 Vilnius, Lithuania.'}, {'ForeName': 'Audrius', 'Initials': 'A', 'LastName': 'Šileikis', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, 03101 Vilnius, Lithuania.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56020052']
3059,32102472,"Frequent Karaoke Training Improves Frontal Executive Cognitive Skills, Tongue Pressure, and Respiratory Function in Elderly People: Pilot Study from a Randomized Controlled Trial.","We tested whether karaoke training improves cognitive skills and reduces the risk of physical function impairments. We conducted a single-blinded randomized controlled trial in 26 elderly participants at residential care facilities, who were generally healthy or required the lowest level of care. Participants were near the threshold for mild cognitive impairment with the Montreal Cognitive Assessment (MoCA) and close to the sarcopenia cut-off with the skeletal muscle mass index. Pulmonary function as measured with spirometry and tongue strength were used as markers for physical functions affected by sarcopenia. Karaoke training occurred once a week for two hours, with an hour of homework assigned weekly. Karaoke training significantly improved the Frontal Assessment Battery at bedside (FAB) compared with an active control group receiving scratch art training ( F  = 8.04, permutation  p -value = 0.013). Subscore improved with inhibitory control ( F  = 7.63, permutation  p -value = 0.015) and sensitivity to interference ( F  = 11.98, permutation  p -value = 0.001). We observed improved tongue pressure ( F  = 4.49, permutation  p -value = 0.040) and pulmonary function by a greater increase in FIV1 ( F  = 5.22, permutation  p -value = 0.047). Engaging elderly people, especially those in care homes, with karaoke training exercises that are moderately physically challenging may be a key to slowing cognitive decline and preventing dysphagia by sarcopenia.",2020,"Subscore improved with inhibitory control ( F  = 7.63, permutation  p -value = 0.015) and sensitivity to interference ( F  = 11.98, permutation  p -value = 0.001).","['Participants were near the threshold for mild cognitive impairment with the Montreal Cognitive Assessment (MoCA) and close to the sarcopenia cut-off with the skeletal muscle mass index', 'Elderly People', '26 elderly participants at residential care facilities, who were generally healthy or required the lowest level of care']","['Karaoke Training', 'karaoke training', 'Karaoke training']","['pulmonary function', 'Frontal Assessment Battery at bedside (FAB', 'sensitivity to interference', 'Frontal Executive Cognitive Skills, Tongue Pressure, and Respiratory Function', 'FIV1', 'cognitive skills', 'tongue pressure', 'risk of physical function impairments']","[{'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C3496286'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C2732353', 'cui_str': 'Frontal assessment battery'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",26.0,0.055229,"Subscore improved with inhibitory control ( F  = 7.63, permutation  p -value = 0.015) and sensitivity to interference ( F  = 11.98, permutation  p -value = 0.001).","[{'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Miyazaki', 'Affiliation': 'Technology and Innovation Hub, Cluster for Science, RIKEN, Saitama 351-0198, Japan.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Mori', 'Affiliation': 'Technology and Innovation Hub, Cluster for Science, RIKEN, Saitama 351-0198, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph17041459']
3060,30933599,Effects Of Alternative Food Voucher Delivery Strategies On Nutrition Among Low-Income Adults.,"Nutrition assistance programs are the subject of ongoing policy debates. Two proposals remain uninformed by existing evidence: whether restricting benefits to allow only fruit and vegetable purchases improves overall dietary intake, and whether more frequent distribution of benefits (weekly versus monthly) induces more fruit and vegetable consumption and less purchasing of calorie-dense foods. In a community-based trial, we randomly assigned participants to receive food vouchers that differed in what foods could be purchased (fruit and vegetables only or any foods) and in distribution schedule (in weekly or monthly installments, holding total monthly value constant). The use of vouchers for fruit and vegetables only did not yield significantly greater improvements than the unrestricted voucher did in terms of fruit and vegetable consumption or Healthy Eating Index (HEI) score. Weekly vouchers also failed to yield significantly greater improvements than monthly vouchers did. Proposed policies to make assistance more restricted or more frequent, while holding benefit value constant, might not improve nutrition among low-income Americans.",2019,The use of vouchers for fruit and vegetables only did not yield significantly greater improvements than the unrestricted voucher did in terms of fruit and vegetable consumption or Healthy Eating Index (HEI) score.,['Low-Income Adults'],"['food vouchers that differed in what foods could be purchased (fruit and vegetables only or any foods) and in distribution schedule', 'Alternative Food Voucher Delivery Strategies']",['fruit and vegetable consumption or Healthy Eating Index (HEI) score'],"[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0286545,The use of vouchers for fruit and vegetables only did not yield significantly greater improvements than the unrestricted voucher did in terms of fruit and vegetable consumption or Healthy Eating Index (HEI) score.,"[{'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Sanjay Basu ( basus@stanford.edu ) is an assistant professor of medicine in the Center for Primary Care and Outcomes Research and the Center for Population Health Sciences, both in the Department of Medicine, Stanford University School of Medicine, in California.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Christopher D. Gardner is a professor of medicine at the Stanford University School of Medicine.'}, {'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'White', 'Affiliation': 'Justin S. White is an assistant professor at the Philip R. Lee Institute for Health Policy Studies, University of California San Francisco (UCSF).'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rigdon', 'Affiliation': 'Joseph Rigdon is a senior biostatistician in the Quantitative Sciences Unit at the Stanford University School of Medicine.'}, {'ForeName': 'Mandy M', 'Initials': 'MM', 'LastName': 'Carroll', 'Affiliation': 'Mandy M. Carroll is a study coordinator in the Department of Medicine, Stanford University School of Medicine.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Akers', 'Affiliation': 'Melissa Akers is a study coordinator in the Division of General Internal Medicine at UCSF.'}, {'ForeName': 'Hilary K', 'Initials': 'HK', 'LastName': 'Seligman', 'Affiliation': 'Hilary K. Seligman is an associate professor of medicine at UCSF.'}]",Health affairs (Project Hope),['10.1377/hlthaff.2018.05405']
3061,31690647,Effectiveness of internet-delivered cognitive behavioural therapy in reducing sickness absence among young employees with depressive symptoms: study protocol for a large-scale pragmatic randomised controlled trial.,"INTRODUCTION


Depression is a highly prevalent condition with typical onset in early adulthood. Internet-delivered cognitive behavioural therapy (iCBT) is a promising cost-effective and more widely available alternative to face-to-face CBT. However, it is not known whether it can reduce sickness absence in employees showing depressive symptoms. The randomised controlled trial component of the DAQI (Depression and sickness absence in young adults: a quasi-experimental trial and web-based treatment intervention) project aims to investigate if iCBT is effective in reducing sickness absence compared with care as usual (CAU) among young employees with depressive symptoms in primary care provided in an occupational health setting.
METHODS AND ANALYSIS


This study will use a randomised controlled single-centre service-based trial of an existing iCBT programme (Mental Hub iCBT for Depression) to evaluate whether or not this treatment can reduce the number of sickness absence days in public sector employees aged 18-34 years who present at the occupational health service with mild depressive symptoms (score ≥9 on the Beck Depression Inventory-IA). Control participants will be offered CAU, with no constraints regarding the range of treatments. The active condition will consist of seven weekly modules of iCBT, with support from a web therapist. Primary outcome will be participants' all-cause sickness absence as indicated in employer's and national administrative records up to 6 months from study entry. Secondary outcomes relating to long-term sickness absence (over 11 calendar days) for mental and musculoskeletal disorders and psychotropic medication use will be obtained from the Finnish Social Insurance Institution's administrative records; and short sickness absence spells (up to 11 calendar days) will be extracted from employer's records. Analyses will be conducted on an intention-to-treat basis.
ETHICS AND DISSEMINATION


The Coordinating Ethics Committee of the Hospital District of Helsinki and Uusimaa has approved the study (HUS/974/2019). The results will be published in peer-reviewed scientific journals and in publications for lay audience.
TRIAL REGISTRATION NUMBER


ISRCTN10877837.",2019,Internet-delivered cognitive behavioural therapy (iCBT) is a promising cost-effective and more widely available alternative to face-to-face CBT.,"['young adults', 'young employees with depressive symptoms in primary care provided in an occupational health setting', 'public sector employees aged 18-34 years who present at the occupational health service with mild depressive symptoms (score ≥9 on the Beck Depression Inventory-IA', 'young employees with depressive symptoms']","['iCBT', 'internet-delivered cognitive behavioural therapy', 'existing iCBT programme (Mental Hub iCBT for Depression', 'Internet-delivered cognitive behavioural therapy (iCBT']","['DAQI (Depression and sickness absence', 'sickness absence', ""participants' all-cause sickness absence"", ""long-term sickness absence (over 11 calendar days) for mental and musculoskeletal disorders and psychotropic medication use will be obtained from the Finnish Social Insurance Institution's administrative records; and short sickness absence spells""]","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0079920', 'cui_str': 'Occupational Health'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0028801', 'cui_str': 'Employee Health Services'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1516147', 'cui_str': 'Calendar'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026857', 'cui_str': 'Orthopedic Disorders'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0037435', 'cui_str': 'Social Insurance'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C1301664', 'cui_str': 'Administrative record'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0331515', 'cui_str': 'Triticum spelta'}]",,0.216238,Internet-delivered cognitive behavioural therapy (iCBT) is a promising cost-effective and more widely available alternative to face-to-face CBT.,"[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kouvonen', 'Affiliation': 'Faculty of Social Sciences, University of Helsinki, Helsinki, Finland anne.kouvonen@helsinki.fi.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Mänty', 'Affiliation': 'Unit of Statistics and Research, City of Vantaa, Vantaa, Finland.'}, {'ForeName': 'Jaakko', 'Initials': 'J', 'LastName': 'Harkko', 'Affiliation': 'Faculty of Social Sciences, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Hilla', 'Initials': 'H', 'LastName': 'Sumanen', 'Affiliation': 'Faculty of Social Sciences, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Konttinen', 'Affiliation': 'Faculty of Social Sciences, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jouni', 'Initials': 'J', 'LastName': 'Lahti', 'Affiliation': 'Faculty of Social Sciences, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Pietilainen', 'Affiliation': 'Department of Public Health, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Blomgren', 'Affiliation': 'Research Unit, The Social Insurance Institution of Finland, Helsinki, Finland.'}, {'ForeName': 'Eevamaija', 'Initials': 'E', 'LastName': 'Tuovinen', 'Affiliation': 'Occupational Health Helsinki, Helsinki, Finland.'}, {'ForeName': 'Eeva-Leena', 'Initials': 'EL', 'LastName': 'Ketonen', 'Affiliation': 'Faculty of Social Sciences, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jan-Henry', 'Initials': 'JH', 'LastName': 'Stenberg', 'Affiliation': 'Department of Psychiatry, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Donnelly', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Børge', 'Initials': 'B', 'LastName': 'Sivertsen', 'Affiliation': 'Department of Public Mental Health, Norwegian Institute of Public Health, Bergen, Norway.'}, {'ForeName': 'Ellenor', 'Initials': 'E', 'LastName': 'Mittendorfer-Rutz', 'Affiliation': 'Department of Clinical Neuroscience, Division of Insurance Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Pirkola', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Ossi', 'Initials': 'O', 'LastName': 'Rahkonen', 'Affiliation': 'Department of Public Health, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Tea', 'Initials': 'T', 'LastName': 'Lallukka', 'Affiliation': 'Department of Public Health, University of Helsinki, Helsinki, Finland.'}]",BMJ open,['10.1136/bmjopen-2019-032119']
3062,32171276,"Effectiveness of a school-based intervention on knowledge, attitude and practice on healthy lifestyle and body composition in Malaysian adolescents.","BACKGROUND


The 'Eat Right, Be Positive About Your Body and Live Actively' (EPaL) intervention programme was developed to prevent overweight and disordered eating in Malaysian adolescents. This study aimed to evaluate the effectiveness of the EPaL programme on knowledge, attitudes and practices on healthy lifestyle and body composition (body mass index z-score [zBMI], waist circumference [WC] and body fat percentage [BF%]) among adolescents.
METHODS


All measures were taken at three time points: before intervention (Pre), after intervention (Post I) and 3 months after intervention (Post II). The intervention group (IG) participated in the EPaL programme for 16 weeks, whereas the comparison group (CG) received no intervention. Seventy-six adolescents (IG: n = 34; CG: n = 42) aged 13-14 years were included in the final analysis. Repeated measures analysis of covariance (ANCOVA) was used to assess the impact of the EPaL intervention programme on the measures between groups (IG and CG) at Post I and Post II.
RESULTS


The IG reported significantly higher knowledge scores at both Post I (adjusted mean difference = 3.34; 95% confidence interval [CI] = 0.99, 5.69; p = 0.006) and Post II (adjusted mean difference = 2.82; 95% CI = 0.86, 4.78; p = 0.005) compared with the CG. No significant differences between the IG and CG were found at either Post I or Post II in attitudes, practices, zBMI, WC and BF%. The proportion of participants who were overweight or obese was consistent from Pre to Post II in the IG (35.3%) and increased from 26.2% at Pre to 28.5% at Post II in the CG, but the difference was not statistically significant. The proportion of participants who had abdominal obesity in the IG decreased from 17.6% at Pre to 14.7% at Post II and increased from 16.7% at Pre to 21.4% at Post II in the CG, but the differences were not statistically significant.
CONCLUSION


Despite no significant reduction of body composition, this programme shows the positive effect on the adolescents' knowledge regarding healthy lifestyle. This study contributes to the evidence on the effectiveness of school-based health interventions in Malaysian adolescents.
TRIAL REGISTRATION


UMIN Clinical Trial Registration UMIN000024349. Registered 11 October 2016.",2020,"No significant differences between the IG and CG were found at either Post I or Post II in attitudes, practices, zBMI, WC and BF%.","['Seventy-six adolescents (IG: n\u2009=\u200934; CG: n\u2009=\u200942) aged 13-14\u2009years', 'Malaysian adolescents', 'adolescents']","['EPaL programme', 'school-based health interventions', 'EPaL) intervention programme', 'school-based intervention', 'EPaL programme for 16\u2009weeks, whereas the comparison group (CG) received no intervention']","['knowledge scores', 'abdominal obesity', 'knowledge, attitudes and practices on healthy lifestyle and body composition (body mass index z-score [zBMI], waist circumference [WC] and body fat percentage [BF', 'body composition']","[{'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0311277', 'cui_str': 'Central Obesity'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}]",,0.0771304,"No significant differences between the IG and CG were found at either Post I or Post II in attitudes, practices, zBMI, WC and BF%.","[{'ForeName': 'Sharifah Intan Zainun', 'Initials': 'SIZ', 'LastName': 'Sharif Ishak', 'Affiliation': 'Department of Healthcare Professional, Faculty of Health and Life Sciences, Management and Science University, 40100, Shah Alam, Selangor, Malaysia.'}, {'ForeName': 'Yit Siew', 'Initials': 'YS', 'LastName': 'Chin', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia. chinys@upm.edu.my.'}, {'ForeName': 'Mohd Nasir', 'Initials': 'MN', 'LastName': 'Mohd Taib', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.'}, {'ForeName': 'Yoke Mun', 'Initials': 'YM', 'LastName': 'Chan', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.'}, {'ForeName': 'Zalilah', 'Initials': 'Z', 'LastName': 'Mohd Shariff', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.'}]",BMC pediatrics,['10.1186/s12887-020-02023-x']
3063,32087032,"Orally applied bacterial lysate in infants at risk for atopy does not prevent atopic dermatitis, allergic rhinitis, asthma or allergic sensitization at school age: Follow-up of a randomized trial.","BACKGROUND


The allergy preventive effects of gut immune modulation by bacterial compounds are still not fully understood.
OBJECTIVE


We sought to evaluate the effect of bacterial lysate applied orally from the second until seventh months of life on the prevalence of allergic diseases at school age.
METHODS


In a randomized, placebo-controlled trial, 606 newborns with at least one allergic parent received orally a bacterial lysate consisting of heat-killed Gram-negative Escherichia coli Symbio and Gram-positive Enterococcus faecalis Symbio or placebo from week 5 until the end of month 7. A total of 402 children were followed until school age (6-11 years) for the assessment of current atopic dermatitis (AD), allergic rhinitis (AR), asthma and sensitization against aeroallergens.
RESULTS


AD was diagnosed in 11.0% (22/200) of children in the active and in 10.4% (21/202) of children in the placebo group. AR was diagnosed in 35% (70/200) of children in the active and in 38.1% (77/202) children in the placebo group. Asthma was diagnosed in 9% (18/199) of children in the active and in 6.6% (13/197) of children in the placebo group. Sensitization occurred in 46.5% (66/142) of participants in the active and 51.7% (76/147) in the placebo group.
CONCLUSION


An oral bacterial lysate of heat-killed Gram-negative Escherichia coli and Gram-positive Enterococcus faecalis applied during the first 7 months of life did not influence the development of AD, asthma and AR at school age.",2020,"Sensitization occurred in 46.5% (66/142) of participants in the active and 51.7% (76/147) in the placebo group.
","['606 newborns with at least one allergic parent received', '402 children were followed until school age (6 to 11 years) for the assessment of current atopic dermatitis (AD), allergic rhinitis (AR), asthma, and sensitization against aero-allergens']","['placebo', 'orally a bacterial lysate consisting of heat-killed gram-negative Escherichia coli Symbio and gram-positive Enterococcus faecalis Symbio or placebo', 'oral bacterial lysate of heat-killed gram-negative Escherichia coli and gram-positive Enterococcus faecalis']","['AR', 'Sensitization', 'atopic dermatitis, allergic rhinitis, asthma or allergic sensitization']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0002092', 'cui_str': 'Allergens'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1569170', 'cui_str': 'polyvalent mechanical bacterial lysate'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C4521763', 'cui_str': 'Killed'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0085494', 'cui_str': 'Enterococcus'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038404', 'cui_str': 'Enterococcus faecalis'}]","[{'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C3662483', 'cui_str': 'Allergic sensitization'}]",606.0,0.40587,"Sensitization occurred in 46.5% (66/142) of participants in the active and 51.7% (76/147) in the placebo group.
","[{'ForeName': 'Siri', 'Initials': 'S', 'LastName': 'Roßberg', 'Affiliation': 'Pediatric Pulmonology, Immunology and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Keller', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Icke', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Siedmann', 'Affiliation': 'Helios Kliniken Berlin-Buch. Kinderklinik, Berlin, Germany.'}, {'ForeName': 'Imke', 'Initials': 'I', 'LastName': 'Lau', 'Affiliation': 'Sektion Humanmedizin, Universität zu Lübeck, Lübeck, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Keil', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Lau', 'Affiliation': 'Pediatric Pulmonology, Immunology and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.'}]",Allergy,['10.1111/all.14247']
3064,30513108,Raltegravir-intensified initial antiretroviral therapy in advanced HIV disease in Africa: A randomised controlled trial.,"BACKGROUND


In sub-Saharan Africa, individuals infected with HIV who are severely immunocompromised have high mortality (about 10%) shortly after starting antiretroviral therapy (ART). This group also has the greatest risk of morbidity and mortality associated with immune reconstitution inflammatory syndrome (IRIS), a paradoxical response to successful ART. Integrase inhibitors lead to significantly more rapid declines in HIV viral load (VL) than all other ART classes. We hypothesised that intensifying standard triple-drug ART with the integrase inhibitor, raltegravir, would reduce HIV VL faster and hence reduce early mortality, although this strategy could also risk more IRIS events.
METHODS AND FINDINGS


In a 2×2×2 factorial open-label parallel-group trial, treatment-naive adults, adolescents, and children >5 years old infected with HIV, with cluster of differentiation 4 (CD4) <100 cells/mm3, from eight urban/peri-urban HIV clinics at regional hospitals in Kenya, Malawi, Uganda, and Zimbabwe were randomised 1:1 to initiate standard triple-drug ART, with or without 12-week raltegravir intensification, and followed for 48 weeks. The primary outcome was 24-week mortality, analysed by intention to treat. Of 2,356 individuals screened for eligibility, 1,805 were randomised between 18 June 2013 and 10 April 2015. Of the 1,805 participants, 961 (53.2%) were male, 72 (4.0%) were children/adolescents, median age was 36 years, CD4 count was 37 cells/mm3, and plasma viraemia was 249,770 copies/mL. Fifty-six participants (3.1%) were lost to follow-up at 48 weeks. By 24 weeks, 97/902 (10.9%) raltegravir-intensified ART versus 91/903 (10.2%) standard ART participants had died (adjusted hazard ratio [aHR] = 1.10 [95% CI 0.82-1.46], p = 0.53), with no evidence of interaction with other randomisations (pheterogeneity > 0.7) and despite significantly greater VL suppression with raltegravir-intensified ART at 4 weeks (343/836 [41.0%] versus 113/841 [13.4%] with standard ART, p < 0.001) and 12 weeks (567/789 [71.9%] versus 415/803 [51.7%] with standard ART, p < 0.001). Through 48 weeks, there was no evidence of differences in mortality (aHR = 0.98 [95% CI 0.76-1.28], p = 0.91); in serious (aHR = 0.99 [0.81-1.21], p = 0.88), grade-4 (aHR = 0.88 [0.71-1.09], p = 0.29), or ART-modifying (aHR = 0.90 [0.63-1.27], p = 0.54) adverse events (the latter occurring in 59 [6.5%] participants with raltegravir-intensified ART versus 66 [7.3%] with standard ART); in events judged compatible with IRIS (occurring in 89 [9.9%] participants with raltegravir-intensified ART versus 86 [9.5%] with standard ART, p = 0.79) or in hospitalisations (aHR = 0.94 [95% CI 0.76-1.17], p = 0.59). At 12 weeks, one and two raltegravir-intensified participants had predicted intermediate-level and high-level raltegravir resistance, respectively. At 48 weeks, the nucleoside reverse transcriptase inhibitor (NRTI) mutation K219E/Q (p = 0.004) and the non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations K101E/P (p = 0.03) and P225H (p = 0.007) were less common in virus from participants with raltegravir-intensified ART, with weak evidence of less intermediate- or high-level resistance to tenofovir (p = 0.06), abacavir (p = 0.08), and rilpivirine (p = 0.07). Limitations of the study include limited clinical, radiological, and/or microbiological information for some participants, reflecting available services at the centres, and lack of baseline genotypes.
CONCLUSIONS


Although 12 weeks of raltegravir intensification was well tolerated and reduced HIV viraemia significantly faster than standard triple-drug ART during the time of greatest risk for early death, this strategy did not reduce mortality or clinical events in this group and is not warranted. There was no excess of IRIS-compatible events, suggesting that integrase inhibitors can be used safely as part of standard triple-drug first-line therapy in severely immunocompromised individuals.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01825031.
TRIAL REGISTRATION


International Standard Randomised Controlled Trials Number ISRCTN 43622374.",2018,"Although 12 weeks of raltegravir intensification was well tolerated and reduced HIV viraemia significantly faster than standard triple-drug ART during the time of greatest risk for early death, this strategy did not reduce mortality or clinical events in this group and is not warranted.","['advanced HIV disease in Africa', '2,356 individuals screened for eligibility, 1,805 were randomised between 18 June 2013 and 10 April 2015', 'naive adults, adolescents, and children >5 years old infected with HIV, with cluster of differentiation 4 (CD4', '1,805 participants, 961 (53.2%) were male, 72 (4.0%) were children/adolescents, median age was 36 years, CD4 count was 37 cells/mm3, and plasma viraemia was 249,770 copies/mL. Fifty-six participants (3.1%) were lost to follow-up at 48 weeks']","['Raltegravir-intensified initial antiretroviral therapy', 'rilpivirine', 'abacavir']","['24-week mortality, analysed by intention to treat', 'VL suppression', 'nucleoside reverse transcriptase inhibitor (NRTI) mutation K219E/Q', 'intermediate-level and high-level raltegravir resistance', 'adverse events', 'tolerated and reduced HIV viraemia', 'mortality']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0910435', 'cui_str': 'AM 36'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0439243', 'cui_str': 'mm3'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C4517683', 'cui_str': '3.1 (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0028621', 'cui_str': 'Nucleosides'}, {'cui': 'C4521921', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C4087436', 'cui_str': 'HIV viraemia'}]",,0.582379,"Although 12 weeks of raltegravir intensification was well tolerated and reduced HIV viraemia significantly faster than standard triple-drug ART during the time of greatest risk for early death, this strategy did not reduce mortality or clinical events in this group and is not warranted.","[{'ForeName': 'Cissy', 'Initials': 'C', 'LastName': 'Kityo', 'Affiliation': 'Joint Clinical Research Centre, Kampala, Uganda.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Szubert', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, University College London, London, United Kingdom.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Siika', 'Affiliation': 'Moi University School of Medicine, Eldoret, Kenya.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Heyderman', 'Affiliation': 'Department/College of Medicine, University of Malawi, and Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Mutsa', 'Initials': 'M', 'LastName': 'Bwakura-Dangarembizi', 'Affiliation': 'University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Lugemwa', 'Affiliation': 'Joint Clinical Research Centre, Mbarara, Uganda.'}, {'ForeName': 'Shalton', 'Initials': 'S', 'LastName': 'Mwaringa', 'Affiliation': 'KEMRI Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Griffiths', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, University College London, London, United Kingdom.'}, {'ForeName': 'Immaculate', 'Initials': 'I', 'LastName': 'Nkanya', 'Affiliation': 'Joint Clinical Research Centre, Kampala, Uganda.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Kabahenda', 'Affiliation': 'Joint Clinical Research Centre, Fort Portal, Uganda.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Wachira', 'Affiliation': 'Moi University School of Medicine, Eldoret, Kenya.'}, {'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Musoro', 'Affiliation': 'University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Chatu', 'Initials': 'C', 'LastName': 'Rajapakse', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, University College London, London, United Kingdom.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Etyang', 'Affiliation': 'KEMRI Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Abach', 'Affiliation': 'Joint Clinical Research Centre, Gulu, Uganda.'}, {'ForeName': 'Moira J', 'Initials': 'MJ', 'LastName': 'Spyer', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, University College London, London, United Kingdom.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Wavamunno', 'Affiliation': 'Joint Clinical Research Centre, Kampala, Uganda.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Nyondo-Mipando', 'Affiliation': 'Department/College of Medicine, University of Malawi, and Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Ennie', 'Initials': 'E', 'LastName': 'Chidziva', 'Affiliation': 'University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Kusum', 'Initials': 'K', 'LastName': 'Nathoo', 'Affiliation': 'University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Klein', 'Affiliation': 'University College London Great Ormond Street Institute of Child Health, University College London, London, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hakim', 'Affiliation': 'University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Gibb', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, University College London, London, United Kingdom.'}, {'ForeName': 'A Sarah', 'Initials': 'AS', 'LastName': 'Walker', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, University College London, London, United Kingdom.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Pett', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, University College London, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1002706']
3065,31843335,Correlation of Prostate-specific Antigen Kinetics with Overall Survival and Radiological Progression-free Survival in Metastatic Castration-sensitive Prostate Cancer Treated with Abiraterone Acetate plus Prednisone or Placebos Added to Androgen Deprivation Therapy: Post Hoc Analysis of Phase 3 LATITUDE Study.,"BACKGROUND


LATITUDE, a randomized, double-blind trial, compared abiraterone acetate and prednisone (AAP) + androgen deprivation therapy (ADT) versus placebo (PBO) + ADT in high-risk metastatic castration-sensitive prostate cancer (mCSPC).
OBJECTIVE


To assess the correlation of prostate-specific antigen (PSA) kinetics with overall survival (OS) and radiological progression-free survival (rPFS).
DESIGN, SETTING, AND PARTICIPANTS


A post hoc analysis of data from 597 men receiving AAP + ADT and 602 receiving PBO + ADT.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The associations of PSA-related outcomes (rates of confirmed 50% [PSA50] and 90% [PSA90] decline from baseline PSA [Prostate Cancer Working Group 2 criteria], rates of PSA < 0.2 ng/ml, median nadir PSA, time to PSA nadir [TPN], and time to PSA progression [TPP] with long-term outcomes [OS and rPFS]) were evaluated. Hazard ratios (HRs) were estimated using Cox proportional hazard model. Correlations of TPP with coprimary endpoints rPFS and OS were evaluated using Kendall's tau (KT).
RESULTS AND LIMITATIONS


AAP + ADT significantly delayed median TPP versus PBO + ADT (33.2 vs 7.4 mo; HR: 0.3, p <  0.001). TPP correlated with rPFS (KT = 0.921) and OS (KT = 0.666). In the AAP + ADT group, 91% had PSA50 and 79% had PSA90 responses (relative risk [RR]: 1.36 and 2.30, respectively; p <  0.001 for both comparisons vs PBO + ADT). Compared with nonresponders, PSA50 and PSA90 responders had reduced risk of death (RR: 0.44 and 0.12, respectively). At 6 mo, 40% receiving AAP + ADT and 6.5% receiving PBO + ADT achieved PSA ≤0.1 ng/ml, which was significantly associated with longer rPFS and OS. Median nadir PSA was 0.09 ng/ml with AAP + ADT versus 2.36 ng/ml with PBO + ADT. Median TPN (AAP + ADT, 6.4 mo; PBO + ADT, 3.8 mo) positively correlated with rPFS and OS.
CONCLUSIONS


Superior PSA response dynamics with AAP + ADT versus ADT + PBO strongly correlated with long-term outcomes of rPFS and OS in high-risk mCSPC.
PATIENT SUMMARY


We found that low prostate-specific antigen levels (≤0.1 ng/ml) after 6 mo may indicate a good long-term response to treatment. Our results need confirmation.",2020,TPP correlated with rPFS (KT = 0.921) and OS (KT = 0.666).,"['597 men receiving AAP\u202f+\u202fADT and 602 receiving PBO\u202f+\u202fADT', 'high-risk metastatic castration-sensitive prostate cancer (mCSPC', 'Metastatic Castration-sensitive Prostate Cancer Treated with']","['PBO + ADT', 'abiraterone acetate and prednisone (AAP) + androgen deprivation therapy (ADT) versus placebo (PBO) + ADT', 'AAP + ADT', 'Abiraterone Acetate plus Prednisone or Placebos']","['low prostate-specific antigen levels', 'PSA90 responses', 'longer rPFS and OS', 'Median TPN', 'delayed median TPP', 'Hazard ratios (HRs', 'prostate-specific antigen (PSA) kinetics with overall survival (OS) and radiological progression-free survival (rPFS', 'Median nadir PSA', 'risk of death', 'median nadir PSA, time to PSA nadir [TPN], and time to PSA progression [TPP']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0051989', 'cui_str': 'Gly-Pro-HyPro-Gly-Ala-Gly'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0051989', 'cui_str': 'Gly-Pro-HyPro-Gly-Ala-Gly'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0030548', 'cui_str': 'Parenteral Hyperalimentation'}, {'cui': 'C1259980', 'cui_str': 'disulfonated meso-tetraphenylporphine'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",597.0,0.228062,TPP correlated with rPFS (KT = 0.921) and OS (KT = 0.666).,"[{'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Matsubara', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan. Electronic address: nmatsuba@east.ncc.go.jp.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'BC Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Cerrahpaşa Medical Faculty, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Rodriguez-Antolin', 'Affiliation': '12 de Octubre University Hospital, Madrid, Spain.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Feyerabend', 'Affiliation': 'Studienpraxis Urologie, Nürtingen, Germany.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Fein', 'Affiliation': 'Instituto de Oncologia de Rosário, Rosário, Argentina.'}, {'ForeName': 'Boris Y', 'Initials': 'BY', 'LastName': 'Alekseev', 'Affiliation': 'P.A. Hertsen Moscow Cancer Research Institute, Moscow, Russian Federation.'}, {'ForeName': 'Giri', 'Initials': 'G', 'LastName': 'Sulur', 'Affiliation': 'Janssen Research & Development, Los Angeles, CA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Protheroe', 'Affiliation': 'Oxford University Hospitals Foundation NHS Trust, Oxford, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Mundle', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'De Porre', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Namphuong', 'Initials': 'N', 'LastName': 'Tran', 'Affiliation': 'Janssen Research & Development, Los Angeles, CA, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Institut Gustave Roussy, University of Paris Sud, Villejuif, France.'}]",European urology,['10.1016/j.eururo.2019.11.021']
3066,32173766,Exercise intensity prescription in cancer survivors: ventilatory and lactate thresholds are useful submaximal alternatives to VO 2peak .,"PURPOSE


Most studies with cancer survivors use percentages of peak oxygen uptake (VO 2peak ) for intensity prescription. Lactate or ventilatory thresholds might be useful submaximal alternatives, but this has never been investigated. Therefore, we aimed at comparing three training sessions prescribed using %VO 2peak  (reference), lactate thresholds, and ventilatory thresholds in terms of meeting the vigorous-intensity zone, physiological, and psychological responses.
METHODS


Twenty breast (58 ± 10 years) and 20 prostate cancer survivors (68 ± 6 years), 3.6 ± 2.4 months after primary therapy, completed a maximal cardiopulmonary exercise test and three vigorous training sessions in randomized order: 38 min of cycling at 70% VO 2peak  (M-VO 2peak ), 97% of individual anaerobic lactate threshold (M-IAT), and 67% between ventilatory thresholds 1 and 2 (M-VT). Heart rate (HR), blood lactate concentration (bLa), perceived exertion, and enjoyment were assessed.
RESULTS


Cancer survivors exercised at 75 ± 23, 85 ± 18, and 79 ± 19 W during M-VO 2peak , M-IAT, and M-VT (p > .05). Sessions could not be completed in 3, 8, and 6 cases. Session completers showed HR of 82 ± 7, 83 ± 9, and 84 ± 8 %HR peak  and bLa of 3.7 ± 1.9, 3.9 ± 0.9, and 3.9 ± 1.5 mmol·l -1 , which was not different between sessions (p > .05). However, variance in bLa was lower in M-IAT compared to M-VO 2peak  (p = .001) and to M-VT (p = .022).
CONCLUSION


All intensity prescription methods on average met the targeted intensity zone. Metabolic response was most homogeneous when using lactate thresholds.
IMPLICATIONS FOR CANCER SURVIVORS


Submaximal thresholds are at least as useful as VO 2peak  for intensity prescription in cancer survivors. Overall, slightly lower percentages should be chosen to improve durability of the training sessions.",2020,"However, variance in bLa was lower in M-IAT compared to M-VO 2peak  (p = .001) and to M-VT (p = .022).
","['cancer survivors', 'FOR CANCER SURVIVORS', 'Twenty breast (58\u2009±\u200910\xa0years) and 20 prostate cancer survivors (68\u2009±\u20096\xa0years), 3.6\u2009±\u20092.4\xa0months after primary therapy, completed a']","['Exercise intensity prescription', 'maximal cardiopulmonary exercise test and three vigorous training sessions']","['Metabolic response', 'Heart rate (HR), blood lactate concentration (bLa), perceived exertion, and enjoyment', 'variance in bLa', 'peak oxygen uptake (VO 2peak ']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}]",,0.0364949,"However, variance in bLa was lower in M-IAT compared to M-VO 2peak  (p = .001) and to M-VT (p = .022).
","[{'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Working Group Exercise Oncology, Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Schlüter', 'Affiliation': 'Working Group Exercise Oncology, Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Sprave', 'Affiliation': 'Department of Radiation Oncology, University Hospital Heidelberg and National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Heidelberg, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Wiskemann', 'Affiliation': 'Working Group Exercise Oncology, Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Rosenberger', 'Affiliation': 'Working Group Exercise Oncology, Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany. friederike.rosenberger@nct-heidelberg.de.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05407-y']
3067,32150141,FOOTFIT Physical Activity mHealth Intervention for Minimally Ambulatory Individuals With Venous Leg Ulcers: A Randomized Controlled Trial.,"PURPOSE


The purpose of this study was to investigate the use of an mHealth application (app), self-management physical activity intervention FOOTFIT with an added patient-provider connectivity feature (FOOTFIT+), that was designed to strengthen the lower extremities of minimally ambulatory individuals with venous leg ulcers (VLUs).
DESIGN


Randomized controlled trial.
SUBJECTS AND SETTING


Twenty-four adults 18 years and older with VLUs being treated in 2 wound clinics in the Southeastern United States participated in this study.
METHODS


Preliminary estimates and 95% confidence intervals for the medians of short-term functional impacts on foot function, strength, ankle range of motion, walking capacity, depression, and physical functioning were obtained pre- and postassessment after the 6-week intervention trial.
RESULTS


There were negligible changes in either group for foot function. It is noted that both groups experienced substantial foot and ankle impairment at baseline. The greatest improvement in range of motion was noted in the FOOTFIT group for dorsiflexion of the right ankle (4.6 ± 5.22 lb/in over baseline) whereas strength decreased in both ankles for dorsiflexion and plantar flexion in the FOOTFIT+ group. No improvements were noted in walking distance or physical health for FOOTFIT (slight decrease -2.9 ± 5.6) and FOOTFIT+ (slight increase 3.0 ± 6.6) during the 6-week study period.
CONCLUSIONS


In a minimally ambulatory population with VLUs, our mHealth FOOTFIT intervention composed of progressive exercise ""boosts"" demonstrated minimal short-term effects. We recommend engagement with the app for a longer period to determine longer-term outcomes of lower extremity function.",2020,The greatest improvement in range of motion was noted in the FOOTFIT group for dorsiflexion of the right ankle (4.6 ± 5.22 lb/in over baseline) whereas strength decreased in both ankles for dorsiflexion and plantar flexion in the FOOTFIT+ group.,"['Minimally Ambulatory Individuals With Venous Leg Ulcers', 'minimally ambulatory individuals with venous leg ulcers (VLUs', 'Twenty-four adults 18 years and older with VLUs being treated in 2 wound clinics in the Southeastern United States participated in this study', 'minimally ambulatory population with VLUs']","['mHealth application (app), self-management physical activity intervention FOOTFIT with an added patient-provider connectivity feature (FOOTFIT', 'FOOTFIT Physical Activity mHealth Intervention']","['walking distance or physical health', 'foot function, strength, ankle range of motion, walking capacity, depression, and physical functioning', 'strength', 'range of motion', 'substantial foot and ankle impairment']","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0023223', 'cui_str': 'Leg Ulcer'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0576183', 'cui_str': 'Joint movement: ankle'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",24.0,0.0442291,The greatest improvement in range of motion was noted in the FOOTFIT group for dorsiflexion of the right ankle (4.6 ± 5.22 lb/in over baseline) whereas strength decreased in both ankles for dorsiflexion and plantar flexion in the FOOTFIT+ group.,"[{'ForeName': 'Teresa J', 'Initials': 'TJ', 'LastName': 'Kelechi', 'Affiliation': 'Teresa J. Kelechi, PhD, RN, CWCN, College of Nursing, Medical University of South Carolina, Charleston. Mohan Madisetti, MS, College of Nursing, Medical University of South Carolina, Charleston. Margie Prentice, MBA, College of Nursing, Medical University of South Carolina, Charleston. Martina Mueller, PhD, College of Nursing, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Madisetti', 'Affiliation': ''}, {'ForeName': 'Margie', 'Initials': 'M', 'LastName': 'Prentice', 'Affiliation': ''}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': ''}]","Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society",['10.1097/WON.0000000000000631']
3068,31515428,"Methotrimeprazine versus haloperidol in palliative care patients with cancer-related nausea: a randomised, double-blind controlled trial.","OBJECTIVES


Methotrimeprazine is commonly used for the management of nausea but never tested formally against other drugs used in this setting. The aim was to demonstrate superior antiemetic efficacy.
DESIGN


Double-blind, randomised, controlled trial of methotrimeprazine versus haloperidol.
SETTING


11 palliative care sites in Australia.
PARTICIPANTS


Participants were >18 years, had cancer, an average nausea score of ≥3/10 and able to tolerate oral medications. Ineligible patients had acute nausea related to treatment, nausea for which a specific antiemetic was indicated, were about to undergo a procedure or had received either of the study drugs or a change in glucocorticoid dose within the previous 48 hours.
INTERVENTIONS


Based on previous studies, haloperidol was used as the control. Participants were randomised to encapsulated methotrimeprazine 6·25 mg or haloperidol 1·5 mg one time or two times per day and assessed every 24 hours for 72 hours.
MAIN OUTCOME MEASURES


A ≥two-point reduction in nausea score at 72 hours from baseline. Secondary outcome measures were as follows: complete response at 72 hours (end nausea score less than 3), response at 24 and 48 hours, vomiting episodes, use of rescue antiemetics, harms and global impression of change.
RESULTS


Response to treatment at 72 hours was 75% (44/59) in the haloperidol (H) arm and 63% (36/57) in the methotrimeprazine (M) arm with no difference between groups (intention-to-treat analysis). Complete response rates were 56% (H) and 51% (M). In the  per protocol  analysis, there was no difference in response rates: (85% (44/52) (H) and 74% (36/49) (M). Complete  per protocol  response rates were 64% (H) and 59% (M). Toxicity worse than baseline was minimal with a trend towards greater sedation in the methotrimeprazine arm.
CONCLUSION


This study did not demonstrate any difference in response rate between methotrimeprazine and haloperidol in the control of nausea.
TRIAL REGISTRATION NUMBER


ACTRN 12615000177550.",2019,"This study did not demonstrate any difference in response rate between methotrimeprazine and haloperidol in the control of nausea.
","['palliative care patients with cancer-related nausea', '11 palliative care sites in Australia', 'Participants were >18 years, had cancer, an average nausea score of ≥3/10 and able to tolerate oral medications']","['methotrimeprazine 6·25\u2009mg or haloperidol', 'Methotrimeprazine', 'methotrimeprazine and haloperidol', 'methotrimeprazine', 'haloperidol']","['Complete  per protocol  response rates', 'nausea score', 'acute nausea', 'follows: complete response at 72\u2009hours (end nausea score less than 3), response at 24 and 48\u2009hours, vomiting episodes, use of rescue antiemetics, harms and global impression of change', 'response rate', 'Toxicity', 'Complete response rates', 'response rates', 'nausea']","[{'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0025678', 'cui_str': 'levomepromazine'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",11.0,0.531726,"This study did not demonstrate any difference in response rate between methotrimeprazine and haloperidol in the control of nausea.
","[{'ForeName': 'Janet Rea', 'Initials': 'JR', 'LastName': 'Hardy', 'Affiliation': 'Department of Palliative and Supportive Care, Mater Misericordiae Ltd, Brisbane, Queensland, Australia Janet.Hardy@mater.org.au.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Skerman', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Philip', 'Affiliation': ""Centre for Palliative Care, St Vincent's Hospital and the University of Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Good', 'Affiliation': 'Department of Palliative and Supportive Care, Mater Misericordiae Ltd, Brisbane, Queensland, Australia.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'Department of Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Mitchell', 'Affiliation': 'Discipline of General Practice, University of Queensland, Ipswich, Queensland, Australia.'}, {'ForeName': 'Patsy', 'Initials': 'P', 'LastName': 'Yates', 'Affiliation': 'School of Nursing, Queensland University of Technology, Brisbane, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-029942']
3069,31519683,The proximal hamstring avulsion clinical trial (PHACT)-a randomised controlled non-inferiority trial of operative versus non-operative treatment of proximal hamstrings avulsions: study protocol.,"INTRODUCTION


The treatment of proximal hamstring avulsions is controversial. While several trials have investigated the outcome for patients treated surgically, there is today no prospective trial comparing operative treatment with non-operative treatment. This protocol describes the design for the proximal hamstring avulsion clinical trial (PHACT)-the first randomised controlled trial of operative versus non-operative treatment for proximal hamstring avulsions.
METHODS AND ANALYSIS


PHACT is a multicentre randomised controlled trial conducted across Sweden, Norway and Finland. Eligible patients (60 participants/treatment arm) with a proximal hamstring avulsion of at least two of three tendons will be randomised to either operative or non-operative treatment. Participants allocated to surgery will undergo reinsertion of the tendons with suture anchors. The rehabilitation programme will be the same for both treatment groups. When patient or surgeon equipoise for treatment alternatives cannot be reached and randomisation therefore is not possible, patients will be invited to participate in a parallel observational non-randomised cohort. The primary outcome will be the patient-reported outcome measure Perth hamstring assessment tool at 24 months. Secondary outcomes include the Lower Extremity Functional Score, physical performance and muscle strength tests, patient satisfaction and MR imaging. Data analysis will be blinded and intention-to-treat analysis will be preformed.
ETHICS AND DISSEMINATION


Ethical approval has been granted by the Ethical Committee of Uppsala University (DNR: 2017-170) and by the Norwegian ethical board (REC: 2017/1911). The study will be conducted in agreement with the Helsinki declaration. The findings will be disseminated in peer-reviewed publications.
TRIAL REGISTRATION NUMBER


NCT03311997.",2019,Eligible patients (60 participants/treatment arm) with a proximal hamstring avulsion of at least two of three tendons will be randomised to either operative or non-operative treatment.,"['Eligible patients (60 participants/treatment arm) with a proximal hamstring avulsion of at least two of three tendons', 'Sweden, Norway and Finland', 'proximal hamstrings avulsions']","['operative versus non-operative treatment', 'operative or non-operative treatment']","['Lower Extremity Functional Score, physical performance and muscle strength tests, patient satisfaction and MR imaging', 'patient-reported outcome measure Perth hamstring assessment tool']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0262386', 'cui_str': 'Avulsion - injury'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2607857'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]",60.0,0.246597,Eligible patients (60 participants/treatment arm) with a proximal hamstring avulsion of at least two of three tendons will be randomised to either operative or non-operative treatment.,"[{'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Pihl', 'Affiliation': 'Karolinska Institutet Danderyds Sjukhus, Karolinska Institutet, Stockholm, Sweden elsa.pihl@ki.se.'}, {'ForeName': 'Målfrid Holen', 'Initials': 'MH', 'LastName': 'Kristoffersen', 'Affiliation': 'Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Anne-Mari', 'Initials': 'AM', 'LastName': 'Rosenlund', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Laszlo', 'Affiliation': 'Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Mida', 'Initials': 'M', 'LastName': 'Berglöf', 'Affiliation': 'Karolinska Institutet Danderyds Sjukhus, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ribom', 'Affiliation': 'Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Eriksson', 'Affiliation': 'Department of Clinical Science and Education Södersjukhuset, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Frihagen', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ville M', 'Initials': 'VM', 'LastName': 'Mattila', 'Affiliation': 'Department of Orthopeadics, Tampere University Hospital, Tampere, Finland, Tampere, Finland.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Schilcher', 'Affiliation': 'Department of Orthopeadic Surgery, Linköping University Hospital, Linkoping, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Eklund', 'Affiliation': 'Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Snellman', 'Affiliation': 'Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Skorpil', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Sköldenberg', 'Affiliation': 'Department of Clinical Sciences, Danderyd Hospital, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Carl Johan', 'Initials': 'CJ', 'LastName': 'Hedbeck', 'Affiliation': 'Karolinska Institutet Danderyds Sjukhus, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Jonsson', 'Affiliation': 'Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-031607']
3070,32128909,Cancer worry and empathy moderate the effect of a survivorship-focused intervention on quality of life.,"OBJECTIVE


This study examined the impact of a survivorship planning consultation (SPC) for patients with Hodgkin's lymphoma and diffuses large B-cell lymphoma on quality of life (QOL). We specifically assessed two potential moderators, cancer worry and perceived empathy, of the intervention effects on QOL.
METHODS


This cluster randomized, four-site trial examined the efficacy of a SPC; physicians received communication skills training and applied these skills in a survivorship-focused office visit using a care plan vs a control arm in which physicians were trained to and subsequently provided a time-controlled, manualized wellness rehabilitation consultation focused only on discussion of healthy nutrition and exercise. We examined the effect of the intervention on patients' QOL and examined potential moderators-cancer worry and perceived physician empathy.
RESULTS


Forty-two physicians and 198 patients participated. There was no main effect of the intervention on any of the QOL dimensions (ps > 0.10). However, cancer worry was a significant moderator of the effects of the intervention on three QOL domains (physical P = .04; social P = .04; spiritual P = .01) and perceived empathy was a significant moderator of QOL (physical P = .004; psychological P = .04; social P = .01). Specifically, the beneficial effects of the intervention were more pronounced among patients who initially reported higher levels of cancer worry and lower levels of physician empathy.
CONCLUSIONS


This study identified two factors, perceived empathy and cancer worry, that were found to impact the QOL of patients who participated in this communication-based survivorship intervention.",2020,There was no main effect of the intervention on any of the QOL dimensions (ps > 0.10).,"['Forty-two physicians and 198 patients participated', ""patients with Hodgkin's lymphoma (HL) and diffuse large B-cell lymphoma (DLBCL"", 'patients who participated in this communication-based survivorship intervention']","['manualized Wellness Rehabilitation Consultation (WRC) focused only on discussion of healthy nutrition and exercise', 'survivorship planning consultation (SPC', 'communication skills training']","['QOL dimensions', 'quality of life', 'cancer worry and lower levels of physician empathy', 'quality of life (QOL']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038955'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038955'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training (procedure)'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}]",198.0,0.0188331,There was no main effect of the intervention on any of the QOL dimensions (ps > 0.10).,"[{'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Parker', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Smita C', 'Initials': 'SC', 'LastName': 'Banerjee', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Matasar', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'Carma L', 'Initials': 'CL', 'LastName': 'Bylund', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Schofield', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Yuelin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Jacobsen', 'Affiliation': 'Division of Cancer Control & Population Sciences, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Astrow', 'Affiliation': 'Department of Medicine, New York Methodist Hospital, Hematology and Oncology, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Leventhal', 'Affiliation': 'Department of Psychology, Rutgers University, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Horwitz', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kissane', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}]",Psycho-oncology,['10.1002/pon.5371']
3071,31932387,Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds.,"OBJECTIVE


Surgical site infection (SSI) affects up to 25% of primary surgical wounds. Dressing strategies may influence SSI risk. The Bluebelle study assessed the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of different dressing strategies to reduce SSI in primary surgical wounds.
DESIGN


A pilot, factorial RCT.
SETTING


Five UK hospitals.
PARTICIPANTS


Adults undergoing abdominal surgery with a primary surgical wound.
INTERVENTIONS


Participants were randomised to 'simple dressing', 'glue-as-a-dressing' or 'no dressing', and to the time at which the treatment allocation was disclosed to the surgeon (disclosure time, before or after wound closure).
PRIMARY AND SECONDARY OUTCOME MEASURES


Feasibility outcomes focused on recruitment, adherence to randomised allocations, reference assessment of SSI and response rates to participant-completed and observer-completed questionnaires to assess SSI (proposed primary outcome for main trial), wound experience and symptoms, and quality of life (EQ-5D-5L).
RESULTS


Between March and November 2016, 1115 patients were screened; 699 (73.4%) were eligible and approached, 415 (59.4%) consented and 394 (35.3%) were randomised (simple dressing=133, glue=129 and 'no dressing'=132). Non-adherence to dressing allocation was 2% (3/133), 6% (8/129) and 15% (20/132), respectively. Adherence to disclosure time was 99% and 86% before and after wound closure, respectively. The overall rate of SSI (reference assessment) was 18.1% (51/281). Response rates to the Wound Healing Questionnaire and other questionnaires ranged from >90% at 4 days to 68% at 4-8 weeks.
CONCLUSIONS


A definitive RCT of dressing strategies including 'no dressing' is feasible. Further work is needed to optimise questionnaire response rates.
TRIAL REGISTRATION NUMBER


49328913; Pre-results.",2020,"Response rates to the Wound Healing Questionnaire and other questionnaires ranged from >90% at 4 days to 68% at 4-8 weeks.
","[' 1115 patients were screened; 699 (73.4%) were eligible and approached, 415 (59.4%) consented and 394 (35.3', 'primary surgical wounds', 'Five UK hospitals', 'Adults undergoing abdominal surgery with a primary surgical wound', 'Between March and November 2016']","[""simple dressing', 'glue-as-a-dressing' or 'no dressing""]","['wound experience and symptoms, and quality of life (EQ-5D-5L', 'overall rate of SSI (reference assessment', 'adherence to dressing allocation', 'Adherence to disclosure time', 'effectiveness and cost-effectiveness', 'recruitment, adherence to randomised allocations, reference assessment of SSI and response rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4517772', 'cui_str': 'Four hundred and fifteen'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332803', 'cui_str': 'Surgical Incision'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0017780', 'cui_str': 'Glues'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4321376', 'cui_str': 'Dressing'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]",1115.0,0.193773,"Response rates to the Wound Healing Questionnaire and other questionnaires ranged from >90% at 4 days to 68% at 4-8 weeks.
","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Blazeby', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK j.m.blazeby@bristol.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-030615']
3072,31718628,Health education through mass media announcements by loudspeakers about malaria care: prevention and practice among people living in a malaria endemic area of northern Myanmar.,"BACKGROUND


Interventions to raise community awareness about malaria prevention and treatment have used various approaches with little evidence on their efficacy. This study aimed to determine the effectiveness of loudspeaker announcements regarding malaria care and prevention practices among people living in the malaria endemic villages of Banmauk Township, Sagaing Region, Myanmar.
METHODS


Four villages among the most malaria-burdened areas were randomly selected: two villages were assigned as the intervention group, and two as the control. Prior to the peak transmission season of malaria in June 2018, a baseline questionnaire was administered to 270 participants from randomly selected households in the control and intervention villages. The loudspeaker announcements broadcasted health messages on malaria care and prevention practices regularly at 7:00 pm every other day. The same questionnaire was administered at 6-month post intervention to both groups. Descriptive statistics, Chi-square, and the t-test were utilized to assess differences between and within groups.
RESULTS


Participants across the control and intervention groups showed similar socio-economic characteristics; the baseline knowledge, attitude and practice mean scores were not significantly different between the groups. Six months after the intervention, improvements in scores were observed at p-value < 0.001 in both groups, however; the increase was greater among the intervention group. The declining trend of malaria was also noticed during the study period. In addition, more than 75% of people expressed positive opinions of the intervention.
CONCLUSIONS


The loudspeaker intervention was found to be feasible and effective, as shown by the significant improvement in scores related to prevention and care-seeking practices for malaria as well as reduced malaria morbidity. Expanding the intervention to a larger population in this endemic region and evaluating its long-term effectiveness are essential in addition to replicating this in other low-resource malaria endemic regions.",2019,"Six months after the intervention, improvements in scores were observed at p-value < 0.001 in both groups, however; the increase was greater among the intervention group.","['people living in the malaria endemic villages of Banmauk Township, Sagaing Region, Myanmar.\nMETHODS\n\n\nFour villages among the most malaria-burdened areas were randomly selected: two villages', '270 participants from randomly selected households in the control and intervention villages', 'people living in a malaria endemic area of northern Myanmar']",['loudspeaker announcements regarding malaria care and prevention practices'],"['malaria morbidity', 'similar socio-economic characteristics; the baseline knowledge, attitude and practice mean scores']","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3879138', 'cui_str': 'Loudspeaker (physical object)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",270.0,0.0239215,"Six months after the intervention, improvements in scores were observed at p-value < 0.001 in both groups, however; the increase was greater among the intervention group.","[{'ForeName': 'Pyae Linn', 'Initials': 'PL', 'LastName': 'Aung', 'Affiliation': 'College of Public Health Sciences, Chulalongkorn University, Bangkok, 10330, Thailand.'}, {'ForeName': 'Tepanata', 'Initials': 'T', 'LastName': 'Pumpaibool', 'Affiliation': 'College of Public Health Sciences, Chulalongkorn University, Bangkok, 10330, Thailand. Tepanata.P@chula.ac.th.'}, {'ForeName': 'Than Naing', 'Initials': 'TN', 'LastName': 'Soe', 'Affiliation': 'Department of Public Health, Ministry of Health and Sports, Naypyitaw, Myanmar.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Burgess', 'Affiliation': 'Division of Infectious Diseases and International Medicine, Department of Internal Medicine, Morsani College of Medicine, University of South Florida, 3720 Spectrum Boulevard, Suite 304, Tampa, FL, 33612, USA.'}, {'ForeName': 'Lynette J', 'Initials': 'LJ', 'LastName': 'Menezes', 'Affiliation': 'Division of Infectious Diseases and International Medicine, Department of Internal Medicine, Morsani College of Medicine, University of South Florida, 3720 Spectrum Boulevard, Suite 304, Tampa, FL, 33612, USA.'}, {'ForeName': 'Myat Phone', 'Initials': 'MP', 'LastName': 'Kyaw', 'Affiliation': 'Myanmar Health Network Organization, Yangon, Myanmar.'}, {'ForeName': 'Liwang', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': 'Division of Infectious Diseases and International Medicine, Department of Internal Medicine, Morsani College of Medicine, University of South Florida, 3720 Spectrum Boulevard, Suite 304, Tampa, FL, 33612, USA. liwangcui@usf.edu.'}]",Malaria journal,['10.1186/s12936-019-2985-6']
3073,31856942,Guided self-help for depression in autistic adults: the ADEPT feasibility RCT.,"BACKGROUND


Co-occurring depression frequently occurs in autism. Evidence-based psychological interventions have been successfully adapted to treat co-occurring anxiety, but there is little evidence about the usefulness of adapted cognitive-behavioural therapy for depression. To the authors' knowledge, to date there have been no randomised trials investigating the usefulness of low-intensity cognitive-behavioural therapy for depression in autism.
OBJECTIVES


The objectives of the study were to (1) develop a low-intensity psychological intervention for depression adapted for autism, (2) assess the feasibility and patient and therapist acceptability of the intervention, (3) estimate the rates of recruitment and retention for a full-scale randomised controlled trial and (4) identify an appropriate measure of depression to be used in a full-scale randomised controlled trial.
DESIGN


The study comprised a randomised controlled trial ( n  = 70) with a nested qualitative evaluation ( n  = 21). Seventy eligible and consenting participants were randomly allocated to guided self-help or to treatment as usual.
SETTING


Adult autism services in two NHS regions.
PARTICIPANTS


Adults with a diagnosis of autism spectrum disorder with depression, that is, a Patient Health Questionnaire-9 items score of ≥ 10. People who had attended more than six sessions of cognitive-behavioural therapy in the previous 6 months were excluded.
INTERVENTIONS


The low-intensity intervention (guided self-help) comprised materials for nine individual sessions, based on behavioural activation adapted for autism, facilitated by therapist guides (coaches) who were graduate-level psychologists who attended training and regular supervision. Treatment as usual was standard NHS care for depression.
MAIN OUTCOME MEASURES


Outcomes were measured 10, 16 and 24 weeks post randomisation using self-report and interview measures of depression, anxiety, obsessive-compulsive symptoms, social function and quality of life, and a health-care and service use questionnaire. As this was a feasibility study also designed to identify the most appropriate measure of depression, it was not possible to specify the primary outcome measure or outcome point a priori.
RESULTS


The aims of the study were met in full. The guided self-help intervention was feasible and well received by participants and coaches. The majority of allocated participants attended the intervention in full. The most practical outcome point was determined to be 16 weeks. There were differential rates of attrition across the treatment groups: 86% of the guided self-help group remained in the study at 24 weeks, compared with 54% of treatment as usual group. The qualitative study suggested that guided self-help had enhanced credibility with participants at the point of randomisation. Inter-rater reliability of the interview measure of depression was less than adequate, limiting the conclusions that can be drawn from the prespecified sensitivity to change analyses.
CONCLUSIONS


The intervention was feasible and well received. Although this feasibility study was not a fully powered trial, it provided some evidence that the guided self-help intervention was effective in reducing depressive symptoms. A full-scale clinical effectiveness and cost-effectiveness trial of the intervention is warranted.
FUTURE WORK


Improvements to the intervention materials as a result of qualitative interviews. Stakeholder consultation to consider future trial design, consider strategies to improve retention in a treatment as usual arm and select a self-report measure of depression to serve as the primary outcome measure.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN54650760.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 68. See the NIHR Journals Library website for further project information. This study was also supported by the NIHR Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol.",2019,"Outcomes were measured 10, 16 and 24 weeks post randomisation using self-report and interview measures of depression, anxiety, obsessive-compulsive symptoms, social function and quality of life, and a health-care and service use questionnaire.","['Adults with a diagnosis of autism spectrum disorder with depression, that is, a Patient Health Questionnaire-9 items score of ≥\u200910', 'autistic adults', 'n \u2009=\u200970) with a nested qualitative evaluation ( n \u2009=\u200921', 'Adult autism services in two NHS regions', 'People who had attended more than six sessions of cognitive-behavioural therapy in the previous 6 months were excluded', 'Seventy eligible and consenting participants']","['low-intensity cognitive-behavioural therapy', 'guided self-help or to treatment as usual', 'low-intensity intervention (guided self-help) comprised materials for nine individual sessions, based on behavioural activation adapted for autism, facilitated by therapist guides (coaches) who were graduate-level psychologists who attended training and regular supervision', 'low-intensity psychological intervention']","['self-report and interview measures of depression, anxiety, obsessive-compulsive symptoms, social function and quality of life, and a health-care and service use questionnaire', 'differential rates of attrition', 'depressive symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0559741', 'cui_str': 'Item score (qualifier value)'}, {'cui': 'C0034375', 'cui_str': 'Qualitative Evaluation'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4087290', 'cui_str': 'Obsessive-compulsive symptom'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",70.0,0.116336,"Outcomes were measured 10, 16 and 24 weeks post randomisation using self-report and interview measures of depression, anxiety, obsessive-compulsive symptoms, social function and quality of life, and a health-care and service use questionnaire.","[{'ForeName': 'Ailsa', 'Initials': 'A', 'LastName': 'Russell', 'Affiliation': 'Centre for Applied Autism Research, Department of Psychology, Faculty of Humanities and Social Sciences, University of Bath, Bath, UK.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Gaunt', 'Affiliation': 'Bristol Randomised Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'Centre for Applied Autism Research, Department of Psychology, Faculty of Humanities and Social Sciences, University of Bath, Bath, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Horwood', 'Affiliation': 'Bristol Randomised Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Barton', 'Affiliation': 'Newcastle Cognitive and Behavioural Therapies Centre, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ensum', 'Affiliation': 'BASS Adult Autism Service, Avon & Wiltshire Mental Health Partnership NHS Trust, Bristol, UK.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Ingham', 'Affiliation': 'Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Parr', 'Affiliation': 'Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Randomised Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Dheeraj', 'Initials': 'D', 'LastName': 'Rai', 'Affiliation': 'School of Social and Community Medicine, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kessler', 'Affiliation': 'School of Social and Community Medicine, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Wiles', 'Affiliation': 'Centre for Academic Mental Health, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23680']
3074,31492117,Participant retention in follow-up studies of prematurely born children.,"BACKGROUND


Follow-up studies of infants born prematurely are essential to understand the long-term consequences of preterm birth and the efficacy of interventions delivered in the neonatal period. Retention of participants for follow-up studies, however, is challenging, with attrition rates of up to 70%. Our aim was to examine retention rates in two follow-up studies of prematurely born children and identify participant or study characteristics that were associated with higher attrition, and to discuss retention strategies with regard to the literature.
METHODS


Data from children recruited at birth to one of two studies of prematurely born infants were assessed. The two studies were the United Kingdom Oscillation Study (UKOS, a randomised study comparing two modes of neonatal ventilation in infants born less than 29 weeks of gestational age (GA)), and an observational study examining the impact of viral lower respiratory tract infections in infancy in those born less than 36 weeks of GA (virus study). The UKOS participants, but not those in the virus study, had regularly been contacted throughout the follow-up period. UKOS subjects were followed up at 11 to 14 years of age and subjects in the virus study at 5-7 years of age. At follow up in both studies, pulmonary function and respiratory morbidity were assessed. Retention rates to follow-up in the two studies and baseline characteristics of those who were and were not retained were assessed.
RESULTS


Retention was significantly higher in UKOS than the virus study (61% versus 35%, p < 0.0001). Subjects lost to UKOS follow up had greater deprivation scores (p < 0.001), a greater likelihood of intrauterine tobacco exposure (p = 0.001) and were more likely to be of non-white ethnicity (p < 0.001). In the virus study, those lost to follow-up had higher birth weights (p = 0.036) and were less likely to be oxygen dependent at hospital discharge (p = 0.003) or be part of a multiple birth (p = 0.048).
CONCLUSIONS


Higher retention was demonstrated when there was regular contact in the follow-up period. Both social factors and initial illness severity affected the retention into follow-up studies of prematurely born infants, though these factors were not consistent across the two studies.",2019,"RESULTS


Retention was significantly higher in UKOS than the virus study (61% versus 35%, p < 0.0001).","['infants born less than 29\u2009weeks of gestational age (GA)), and an observational study examining the impact of viral lower respiratory tract infections in infancy in those born less than 36\u2009weeks of GA (virus study', 'UKOS subjects were followed up at 11 to 14\u2009years of age and subjects in the virus study at 5-7\u2009years of age', 'prematurely born children', 'Data from children recruited at birth to one of two studies of prematurely born infants']",['neonatal ventilation'],"['deprivation scores', 'Retention', 'pulmonary function and respiratory morbidity', 'higher birth weights', 'likelihood of intrauterine tobacco exposure', 'Retention rates', 'retention rates']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0852110', 'cui_str': 'Lower respiratory tract infection viral'}, {'cui': 'C0231330', 'cui_str': 'Infancy - period'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}, {'cui': 'C0349482', 'cui_str': 'High birth weight baby'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",,0.0493949,"RESULTS


Retention was significantly higher in UKOS than the virus study (61% versus 35%, p < 0.0001).","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'MacBean', 'Affiliation': 'Centre for Human Performance, Exercise and Rehabilitation, Brunel University London, London, UK.'}, {'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Drysdale', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Zivanovic', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Peacock', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Greenough', 'Affiliation': ""NIHR Biomedical Research Centre at Guy's & St Thomas' NHS Foundation Trust and King's College London, London, UK. anne.greenough@kcl.ac.uk.""}]",BMC public health,['10.1186/s12889-019-7575-6']
3075,32092060,Safety and immune responses after a 12-month booster in healthy HIV-uninfected adults in HVTN 100 in South Africa: A randomized double-blind placebo-controlled trial of ALVAC-HIV (vCP2438) and bivalent subtype C gp120/MF59 vaccines.,"BACKGROUND


HVTN 100 evaluated the safety and immunogenicity of an HIV subtype C pox-protein vaccine regimen, investigating a 12-month booster to extend vaccine-induced immune responses.
METHODS AND FINDINGS


A phase 1-2 randomized double-blind placebo-controlled trial enrolled 252 participants (210 vaccine/42 placebo; median age 23 years; 43% female) between 9 February 2015 and 26 May 2015. Vaccine recipients received ALVAC-HIV (vCP2438) alone at months 0 and 1 and with bivalent subtype C gp120/MF59 at months 3, 6, and 12. Antibody (IgG, IgG3 binding, and neutralizing) and CD4+ T-cell (expressing interferon-gamma, interleukin-2, and CD40 ligand) responses were evaluated at month 6.5 for all participants and at months 12, 12.5, and 18 for a randomly selected subset. The primary analysis compared IgG binding antibody (bAb) responses and CD4+ T-cell responses to 3 vaccine-matched antigens at peak (month 6.5 versus 12.5) and durability (month 12 versus 18) timepoints; IgG responses to CaseA2_gp70_V1V2.B, a primary correlate of risk in RV144, were also compared at these same timepoints. Secondary and exploratory analyses compared IgG3 bAb responses, IgG bAb breadth scores, neutralizing antibody (nAb) responses, antibody-dependent cellular phagocytosis, CD4+ polyfunctionality responses, and CD4+ memory sub-population responses at the same timepoints. Vaccines were generally safe and well tolerated. During the study, there were 2 deaths (both in the vaccine group and both unrelated to study products). Ten participants became HIV-infected during the trial, 7% (3/42) of placebo recipients and 3% (7/210) of vaccine recipients. All 8 serious adverse events were unrelated to study products. Less waning of immune responses was seen after the fifth vaccination than after the fourth, with higher antibody and cellular response rates at month 18 than at month 12: IgG bAb response rates to 1086.C V1V2, 21.0% versus 9.7% (difference = 11.3%, 95% CI = 0.6%-22.0%, P = 0.039), and ZM96.C V1V2, 21.0% versus 6.5% (difference = 14.5%, 95% CI = 4.1%-24.9%, P = 0.004). IgG bAb response rates to all 4 primary V1V2 antigens were higher 2 weeks after the fifth vaccination than 2 weeks after the fourth vaccination: 87.7% versus 75.4% (difference = 12.3%, 95% CI = 1.7%-22.9%, P = 0.022) for 1086.C V1V2, 86.0% versus 63.2% (difference = 22.8%, 95% CI = 9.1%-36.5%, P = 0.001) for TV1c8.2.C V1V2, 67.7% versus 44.6% (difference = 23.1%, 95% CI = 10.4%-35.7%, P < 0.001) for ZM96.C V1V2, and 81.5% versus 60.0% (difference = 21.5%, 95% CI = 7.6%-35.5%, P = 0.002) for CaseA2_gp70_V1V2.B. IgG bAb response rates to the 3 primary vaccine-matched gp120 antigens were all above 90% at both peak timepoints, with no significant differences seen, except a higher response rate to ZM96.C gp120 at month 18 versus month 12: 64.5% versus 1.6% (difference = 62.9%, 95% CI = 49.3%-76.5%, P < 0.001). CD4+ T-cell response rates were higher at month 18 than month 12 for all 3 primary vaccine-matched antigens: 47.3% versus 29.1% (difference = 18.2%, 95% CI = 2.9%-33.4%, P = 0.021) for 1086.C, 61.8% versus 38.2% (difference = 23.6%, 95% CI = 9.5%-37.8%, P = 0.001) for TV1.C, and 63.6% versus 41.8% (difference = 21.8%, 95% CI = 5.1%-38.5%, P = 0.007) for ZM96.C, with no significant differences seen at the peak timepoints. Limitations were that higher doses of gp120 were not evaluated, this study was not designed to investigate HIV prevention efficacy, and the clinical significance of the observed immunological effects is uncertain.
CONCLUSIONS


In this study, a 12-month booster of subtype C pox-protein vaccines restored immune responses, and slowed response decay compared to the 6-month vaccination.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02404311. South African National Clinical Trials Registry (SANCTR number: DOH--27-0215-4796).",2020,"CD4+ T-cell response rates were higher at month 18 than month 12 for all 3 primary vaccine-matched antigens: 47.3% versus 29.1% (difference = 18.2%, 95% CI = 2.9%-33.4%, P = 0.021) for 1086.C, 61.8% versus 38.2% (difference = 23.6%, 95% CI = 9.5%-37.8%, P = 0.001) for TV1.C, and 63.6% versus 41.8% (difference = 21.8%, 95% CI = 5.1%-38.5%, P = 0.007) for ZM96.C, with no significant differences seen at the peak timepoints.","['252 participants (210 vaccine/42 placebo; median age 23 years; 43% female) between 9 February 2015 and 26 May 2015', 'healthy HIV-uninfected adults in HVTN 100 in South Africa']","['placebo', 'ALVAC-HIV (vCP2438) alone at months 0 and 1 and with bivalent subtype C gp120/MF59', 'expressing interferon-gamma, interleukin-2, and CD40 ligand', 'ALVAC-HIV (vCP2438) and bivalent subtype C gp120/MF59 vaccines']","['safe and well tolerated', 'cellular response rates', 'CD4+ T-cell response rates', 'IgG binding antibody (bAb) responses and CD4+ T-cell responses', 'IgG bAb response rates', 'HIV prevention efficacy', 'durability', 'Antibody (IgG, IgG3 binding, and neutralizing) and CD4+ T-cell ', 'Safety and immune responses', 'IgG3 bAb responses, IgG bAb breadth scores, neutralizing antibody (nAb) responses, antibody-dependent cellular phagocytosis, CD4+ polyfunctionality responses, and CD4+ memory sub-population responses']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0675907', 'cui_str': 'ALVAC-HIV'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0019691', 'cui_str': 'Envelope Glycoprotein gp120, HIV'}, {'cui': 'C0289787', 'cui_str': 'MF59'}, {'cui': 'C0021745', 'cui_str': 'interferon gamma'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0167627', 'cui_str': 'T-B Cell Activating Molecule'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0020859', 'cui_str': 'IgG3'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",252.0,0.458219,"CD4+ T-cell response rates were higher at month 18 than month 12 for all 3 primary vaccine-matched antigens: 47.3% versus 29.1% (difference = 18.2%, 95% CI = 2.9%-33.4%, P = 0.021) for 1086.C, 61.8% versus 38.2% (difference = 23.6%, 95% CI = 9.5%-37.8%, P = 0.001) for TV1.C, and 63.6% versus 41.8% (difference = 21.8%, 95% CI = 5.1%-38.5%, P = 0.007) for ZM96.C, with no significant differences seen at the peak timepoints.","[{'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Laher', 'Affiliation': 'Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Moodie', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Kristen W', 'Initials': 'KW', 'LastName': 'Cohen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Grunenberg', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Frahm', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Yates', 'Affiliation': 'Departments of Surgery and Immunology, Duke Human Vaccine Institute, Durham, North Carolina, United States of America.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Morris', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'Mookho', 'Initials': 'M', 'LastName': 'Malahleha', 'Affiliation': 'Setshaba Research Centre, Soshanguve, South Africa.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Mngadi', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, Durban, South Africa.'}, {'ForeName': 'Brodie', 'Initials': 'B', 'LastName': 'Daniels', 'Affiliation': 'South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Innes', 'Affiliation': 'Aurum Institute, Klerksdorp Research Centre, Klerksdorp, South Africa.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Saunders', 'Affiliation': 'Departments of Surgery and Immunology, Duke Human Vaccine Institute, Durham, North Carolina, United States of America.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Grant', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gilbert', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Phogat', 'Affiliation': 'Sanofi Pasteur, Swiftwater, Pennsylvania, United States of America.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'DiazGranados', 'Affiliation': 'Sanofi Pasteur, Swiftwater, Pennsylvania, United States of America.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Koutsoukos', 'Affiliation': 'GSK Vaccines, Rixensart, Belgium.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Van Der Meeren', 'Affiliation': 'GSK Vaccines, Rixensart, Belgium.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Bentley', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Nonhlanhla N', 'Initials': 'NN', 'LastName': 'Mkhize', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Pensiero', 'Affiliation': 'Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.'}, {'ForeName': 'Vijay L', 'Initials': 'VL', 'LastName': 'Mehra', 'Affiliation': 'Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Departments of Surgery and Immunology, Duke Human Vaccine Institute, Durham, North Carolina, United States of America.'}, {'ForeName': 'Glenda E', 'Initials': 'GE', 'LastName': 'Gray', 'Affiliation': 'Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Departments of Surgery and Immunology, Duke Human Vaccine Institute, Durham, North Carolina, United States of America.'}]",PLoS medicine,['10.1371/journal.pmed.1003038']
3076,31504336,The Effect of Helminth Infections and Their Treatment on Metabolic Outcomes: Results of a Cluster-Randomized Trial.,"BACKGROUND


Helminths may protect against cardiometabolic risk through effects on inflammation and metabolism; their treatment may be detrimental to metabolic outcomes.
METHODS


In a cluster-randomized trial in 26 Ugandan fishing communities we investigated effects of community-wide intensive (quarterly single-dose praziquantel, triple-dose albendazole) vs standard (annual single-dose praziquantel, biannual single-dose albendazole) anthelminthic treatment on metabolic outcomes, and observational associations between helminths and metabolic outcomes. The primary outcome, homeostatic model assessment of insulin resistance (HOMA-IR), and secondary outcomes (including blood pressure, fasting blood glucose, lipids) were assessed after 4 years' intervention among individuals aged ≥10 years.
RESULTS


We analyzed 1898 participants. Intensive treatment had no effect on HOMA-IR (adjusted geometric mean ratio, 0.96 [95% confidence interval {CI}, .86-1.07]; P = .42) but resulted in higher mean low-density lipoprotein cholesterol (LDL-c) (2.86 vs 2.60 mmol/L; adjusted mean difference, 0.26 [95% CI, -.03 to .56]; P = .08). Lower LDL-c levels were associated with Schistosoma mansoni (2.37 vs 2.80 mmol/L; -0.25 [95% CI, -.49 to -.02]; P = .04) or Strongyloides (2.34 vs 2.69 mmol/L; -0.32 [95% CI, -.53 to -.12]; P = .003) infection. Schistosoma mansoni was associated with lower total cholesterol (4.24 vs 4.64 mmol/L; -0.25 [95% CI, -.44 to -.07]; P = .01) and moderate to heavy S. mansoni infection with lower triglycerides, LDL-c, and diastolic blood pressure.
CONCLUSIONS


Helminth infections improve lipid profiles and may lower blood pressure. Studies to confirm causality and investigate mechanisms may contribute to understanding the epidemiological transition and suggest new approaches to prevent cardiometabolic disease.
CLINICAL TRIALS REGISTRATION


ISRCTN47196031.",2020,"S. mansoni infection was associated with lower total cholesterol levels (4.24 vs 4.64 mmol/L, -0.25","['26 fishing communities, Lake Victoria, Uganda', 'Participants with moderate to heavy S. mansoni infection', '1898 participants']","['community-wide intensive (quarterly single-dose praziquantel, triple dose albendazole']","['metabolic outcomes', 'Lower LDL-cholesterol levels', 'blood pressure', 'lower triglycerides, LDL-cholesterol and diastolic blood pressure levels', 'mean LDL-cholesterol', 'HOMA-IR', 'total cholesterol levels', 'homeostatic model assessment of insulin resistance (HOMA-IR) and secondary outcomes (including blood pressure, fasting blood glucose and lipids']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0337049', 'cui_str': 'Lakes'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332179', 'cui_str': 'q3mo'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}]","[{'cui': 'C0853085', 'cui_str': 'Decreased LDL'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]",1898.0,0.334987,"S. mansoni infection was associated with lower total cholesterol levels (4.24 vs 4.64 mmol/L, -0.25","[{'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Sanya', 'Affiliation': 'Immunomodulation and Vaccines Programme, Medical Research Council (MRC)/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Webb', 'Affiliation': 'MRC Tropical Epidemiology Group, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Zziwa', 'Affiliation': 'Immunomodulation and Vaccines Programme, Medical Research Council (MRC)/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kizindo', 'Affiliation': 'Immunomodulation and Vaccines Programme, Medical Research Council (MRC)/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Sewankambo', 'Affiliation': 'Immunomodulation and Vaccines Programme, Medical Research Council (MRC)/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Tumusiime', 'Affiliation': 'Immunomodulation and Vaccines Programme, Medical Research Council (MRC)/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Nakazibwe', 'Affiliation': 'Immunomodulation and Vaccines Programme, Medical Research Council (MRC)/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Oduru', 'Affiliation': 'Immunomodulation and Vaccines Programme, Medical Research Council (MRC)/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Niwagaba', 'Affiliation': 'Immunomodulation and Vaccines Programme, Medical Research Council (MRC)/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Prossy Kabuubi', 'Initials': 'PK', 'LastName': 'Nakawungu', 'Affiliation': 'Immunomodulation and Vaccines Programme, Medical Research Council (MRC)/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Kabagenyi', 'Affiliation': 'Immunomodulation and Vaccines Programme, Medical Research Council (MRC)/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Jacent', 'Initials': 'J', 'LastName': 'Nassuuna', 'Affiliation': 'Immunomodulation and Vaccines Programme, Medical Research Council (MRC)/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Bridgious', 'Initials': 'B', 'LastName': 'Walusimbi', 'Affiliation': 'Immunomodulation and Vaccines Programme, Medical Research Council (MRC)/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Andia-Biraro', 'Affiliation': 'Immunomodulation and Vaccines Programme, Medical Research Council (MRC)/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Elliott', 'Affiliation': 'Immunomodulation and Vaccines Programme, Medical Research Council (MRC)/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz859']
3077,30368852,Substance Abusing Mothers with a History of Childhood Abuse and Their Children's Depressive Symptoms: The Efficacy of Family Therapy.,"This study examined the associations among maternal history of childhood abuse, substance use, and depressive symptoms and the change in children's depressive symptoms in therapy. Mothers (N = 183) were randomly assigned into either a family or an individual treatment condition. Mothers were assessed for their childhood abuse retrospectively, baseline depressive symptoms, and substance use, whereas their children's depressive symptoms were measured five times during 1.5 years. Maternal childhood abuse was associated with a slower decline in child depressive symptoms through elevated maternal depressive symptoms, only in individual treatment. Maternal substance use further moderated this mediation pathway. This study supports the efficacy of family therapy in protecting children of mothers with a substance use disorder and a history of childhood abuse.",2020,"Maternal childhood abuse was associated with a slower decline in child depressive symptoms through elevated maternal depressive symptoms, only in individual treatment.","[""Substance Abusing Mothers with a History of Childhood Abuse and Their Children's Depressive Symptoms"", 'Mothers (N\xa0=\xa0183', 'protecting children of mothers with a substance use disorder and a history of childhood abuse']",[],"['child depressive symptoms through elevated maternal depressive symptoms', 'Maternal childhood abuse']","[{'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}]",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}]",183.0,0.0334014,"Maternal childhood abuse was associated with a slower decline in child depressive symptoms through elevated maternal depressive symptoms, only in individual treatment.","[{'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Florida State University.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Slesnick', 'Affiliation': 'Ohio State University.'}]",Journal of marital and family therapy,['10.1111/jmft.12364']
3078,31179007,"Geographically linked risk factors for enrolment into a fast breathing child pneumonia trial in Lilongwe, Malawi: an Innovative Treatments in Pneumonia (ITIP) secondary analysis.","Background


Pneumonia is the leading infectious killer of children less than 5 years of age worldwide. In addition to vaccines that help prevent pneumonia, understanding the environmental and socioeconomic risk factors for child pneumonia is critical to further prevention.
Methods


Data from children with fast breathing pneumonia enrolled in a non-inferiority clinical trial assessing the effectiveness of 3-day placebo versus antibiotic treatment in Lilongwe, Malawi were used to examine environmental and socioeconomic characteristics within the study population. Location of residence was collected for enrolled children, and spatial enrolment rates were compared across Lilongwe using a spatial scan statistic.
Results


Data from 1101 children were analysed. Three urban subdistricts (locally known as 'Areas') (Areas 24, 36 and 38) out of 51 were identified with higher than expected enrolment. These three areas were associated with higher rates of poverty (37.8% vs 23.9%) as well as informal settlements and poorer sanitation (42.4% vs 7.4%) than other areas. Parents of enrolled children from these areas also had lower rates of secondary education compared with parents of children enrolled from other areas (55% vs 67% (p<0.01) among fathers; 47% vs 54% (p<0.01) among mothers).
Conclusion


In Lilongwe, areas with higher rates of poverty, informal settlements and poor sanitation contributed higher than expected enrolment of children to our fast breathing child pneumonia clinical trial when compared with other areas. Additional research is needed to evaluate the impact of environmental and socioeconomic risk factors, along with vaccination status, on the incidence of fast breathing pneumonia in children living in this region.",2019,"Parents of enrolled children from these areas also had lower rates of secondary education compared with parents of children enrolled from other areas (55% vs 67% (p<0.01) among fathers; 47% vs 54% (p<0.01) among mothers).
","['children with fast breathing pneumonia enrolled in a non-inferiority clinical trial', 'children living in this region', ""Three urban subdistricts (locally known as 'Areas"", '1101 children']",['placebo'],['rates of poverty'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032854', 'cui_str': 'Poverty'}]",1101.0,0.0410504,"Parents of enrolled children from these areas also had lower rates of secondary education compared with parents of children enrolled from other areas (55% vs 67% (p<0.01) among fathers; 47% vs 54% (p<0.01) among mothers).
","[{'ForeName': 'Evangelyn', 'Initials': 'E', 'LastName': 'Nkwopara', 'Affiliation': 'International Programs, Save the Children Federation, Fairfield, Connecticut, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schmicker', 'Affiliation': 'Biostatistics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Tisungane', 'Initials': 'T', 'LastName': 'Mvalo', 'Affiliation': 'University of North Carolina Project, Lilongwe, Central Region, Malawi.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'May', 'Affiliation': 'Biostatistics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Amy Sarah', 'Initials': 'AS', 'LastName': 'Ginsburg', 'Affiliation': 'International Programs, Save the Children Federation, Fairfield, Connecticut, USA.'}]",BMJ open respiratory research,['10.1136/bmjresp-2019-000414']
3079,32000687,Comparison of the effects of lanthanum carbonate and calcium carbonate on the progression of cardiac valvular calcification after initiation of hemodialysis.,"BACKGROUND


Although mineral metabolism disorder influences cardiac valvular calcification (CVC), few previous studies have examined the effects of non-calcium-containing and calcium-containing phosphate binders on CVC in maintenance hemodialysis patients. The aim of the present study was to compare the effects of lanthanum carbonate (LC) with calcium carbonate (CC) on the progression of CVC in patients who initiated maintenance hemodialysis and to investigate clinical factors related to CVC.
METHODS


The current study included 50 subjects (mean age 65 years, 72% males) from our previous randomized controlled trial (LC group, N = 24; CC group, N = 26). CVC was evaluated as CVC score (CVCS) using echocardiography at baseline and 18 months after initiation of hemodialysis. We compared CVCS and the changes between the two groups. We also analyzed the associations between CVCS and any other clinical factors including arterial plaque score (PS) and serum phosphorus levels.
RESULTS


Baseline characteristics of study participants including CVCS were almost comparable between the two groups. At 18 months, there were no significant differences in mineral metabolic markers or CVCS between the two groups, and CVCS were significantly correlated with PS (r = 0.39, p < 0.01). Furthermore, changes in CVCS were significantly correlated with average phosphorus levels (r = 0.36, p < 0.05), which were significantly higher in high serum phosphorus and high PS group compared to low serum phosphorus and low PS group (p < 0.05).
CONCLUSIONS


In the present study, there were no significant differences between LC and CC with regard to progression of CVC. However, serum phosphorus levels and arterial plaque seem to be important for the progression and formation of CVC in hemodialysis patients.",2020,"At 18 months, there were no significant differences in mineral metabolic markers or CVCS between the two groups, and CVCS were significantly correlated with PS (r = 0.39, p < 0.01).","['50 subjects (mean age 65\u2009years, 72% males', 'patients who initiated maintenance hemodialysis and to investigate clinical factors related to CVC', 'maintenance hemodialysis patients', 'hemodialysis patients']","['lanthanum carbonate (LC) with calcium carbonate (CC', 'lanthanum carbonate and calcium carbonate']","['CVCS', 'arterial plaque score (PS) and serum phosphorus levels', 'progression of cardiac valvular calcification', 'CVC score (CVCS', 'average phosphorus levels', 'mineral metabolic markers or CVCS']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0768119', 'cui_str': 'lanthanum carbonate'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}]","[{'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}]",50.0,0.0154165,"At 18 months, there were no significant differences in mineral metabolic markers or CVCS between the two groups, and CVCS were significantly correlated with PS (r = 0.39, p < 0.01).","[{'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Division of Nephrology and Kidney Center, Kobe University Graduate School of Medicine, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Fujii', 'Affiliation': 'Division of Nephrology and Kidney Center, Kobe University Graduate School of Medicine, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan. fhideki@med.kobe-u.ac.jp.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Kono', 'Affiliation': 'Division of Nephrology and Kidney Center, Kobe University Graduate School of Medicine, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Goto', 'Affiliation': 'Division of Nephrology and Kidney Center, Kobe University Graduate School of Medicine, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Nishi', 'Affiliation': 'Division of Nephrology and Kidney Center, Kobe University Graduate School of Medicine, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01343-1']
3080,31895461,Association of Weekly Protected Nonclinical Time With Resident Physician Burnout and Well-being.,"Importance


Burnout among physicians is high, with resulting concern about quality of care. With burnout beginning early in physician training, much-needed data are lacking on interventions to decrease burnout and improve well-being among resident physicians.
Objectives


To design a departmental-level burnout intervention, evaluate its association with otolaryngology residents' burnout and well-being, and describe how residents used and perceived the study intervention.
Design, Setting, and Participants


A prospective, nonrandomized crossover study was conducted from September 25, 2017, to June 24, 2018, among all 19 current residents in the Department of Otolaryngology at the University of Minnesota. Statistical analysis was performed from June 28 to August 7, 2018.
Interventions


All participants were assigned 2 hours per week of protected nonclinical time alternating with a control period of no intervention at 6-week intervals.
Main Outcomes and Measures


Burnout was measured by the Maslach Burnout Inventory and Mini-Z Survey. Well-being was measured by the Resident and Fellow Well-Being Index and a quality-of-life single-item self-assessment. In addition to a baseline demographic survey, participants completed the aforementioned surveys at approximately 6-week intervals during the study period.
Results


Among the 19 residents in the study (10 men [53%]), the overall protected time intervention (week 0 to week 32) was associated with a mean decrease of 0.63 points (95% CI, -1.03 to -0.22 points) in the Maslach Burnout Inventory emotional exhaustion score, indicating a clinically meaningful decrease in burnout, and a mean decrease of 1.26 points (95% CI, -2.18 to -0.34 points) in the Resident and Fellow Well-Being Index score, indicating a clinically meaningful improvement in well-being. The baseline to week 32 mean changes in the Maslach Burnout Inventory depersonalization score, Maslach Burnout Inventory personal accomplishment score, and quality-of-life single-item self-assessment were not clinically meaningful. There were clinically meaningful improvements in 4 of 6 tested Mini-Z Questionnaire items from baseline to week 32: job stress (weighted κ statistic, 0.21; 95% CI, -0.11 to 0.53), burnout (weighted κ statistic, 0.25; 95% CI, -0.02 to 0.53), control over workload (weighted κ statistic, 0.26; 95% CI, -0.01 to 0.53), and sufficient time for documentation (weighted κ statistic, 0.31; 95% CI, 0.08 to 0.54).
Conclusions and Relevance


This study found that 2 hours per week of protected nonclinical time was associated with decreased burnout and increased well-being in a small sample of otolaryngology residents. Future randomized clinical studies in larger cohorts are warranted to infer causality of decreased burnout and increased well-being as a result of protected nonclinical time.",2020,"There were clinically meaningful improvements in 4 of 6 tested Mini-Z Questionnaire items from baseline to week 32: job stress (weighted κ statistic, 0.21; 95% CI, -0.11 to 0.53), burnout (weighted κ statistic, 0.25; 95% CI, -0.02 to 0.53), control over workload (weighted κ statistic, 0.26; 95% CI, -0.01 to 0.53), and sufficient time for documentation (weighted κ statistic, 0.31; 95% CI, 0.08 to 0.54).
","['September 25, 2017, to June 24, 2018, among all 19 current residents in the Department of Otolaryngology at the University of Minnesota']",[],"['Maslach Burnout Inventory emotional exhaustion score', 'Maslach Burnout Inventory depersonalization score, Maslach Burnout Inventory personal accomplishment score, and quality-of-life single-item self-assessment']","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0029892', 'cui_str': 'Otorhinolaryngology'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}]",[],"[{'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011551', 'cui_str': 'Depersonalization'}, {'cui': 'C0034380'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}]",,0.0379207,"There were clinically meaningful improvements in 4 of 6 tested Mini-Z Questionnaire items from baseline to week 32: job stress (weighted κ statistic, 0.21; 95% CI, -0.11 to 0.53), burnout (weighted κ statistic, 0.25; 95% CI, -0.02 to 0.53), control over workload (weighted κ statistic, 0.26; 95% CI, -0.01 to 0.53), and sufficient time for documentation (weighted κ statistic, 0.31; 95% CI, 0.08 to 0.54).
","[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Stevens', 'Affiliation': 'Department of Otolaryngology, University of Minnesota, Minneapolis.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Davey', 'Affiliation': 'Clinical and Translational Science Institute, Biostatistical Design and Analysis Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Amy Anne', 'Initials': 'AA', 'LastName': 'Lassig', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Minnesota, Minneapolis.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2019.3654']
3081,31229990,"Prevention of recurrent idiopathic gastroduodenal ulcer bleeding: a double-blind, randomised trial.","OBJECTIVE


Patients with a history of  Helicobacter pylori -negative idiopathic bleeding ulcers have a considerable risk of recurrent ulcer complications. We hypothesised that a proton pump inhibitor (lansoprazole) is superior to a histamine 2 receptor antagonist (famotidine) for the prevention of recurrent ulcer bleeding in such patients.
DESIGN


In this industry-independent, double-blind, randomised trial, we recruited patients with a history of idiopathic bleeding ulcers. After ulcer healing, we randomly assigned (1:1) patients to receive oral lansoprazole 30 mg or famotidine 40 mg daily for 24 months. The primary endpoint was recurrent upper GI bleeding within 24 months, analysed in the intention-to-treat population as determined by an independent adjudication committee.
RESULTS


Between 2010 and 2018, we enrolled 228 patients (114 patients in each study group). Recurrent upper GI bleeding occurred in one patient receiving lansoprazole (duodenal ulcer) and three receiving famotidine (two gastric ulcers and one duodenal ulcer). The cumulative incidence of recurrent upper GI bleeding in 24 months was 0.88% (95% CI 0.08% to 4.37%) in the lansoprazole arm and 2.63% (95% CI 0.71% to 6.91%) in the famotidine arm (p = 0.313; crude HR 0.33, 95% CI 0.03 to 3.16, p = 0.336). None of the patients who rebled used aspirin, non-steroidal anti-inflammatory drugs or other antithrombotic drugs.
CONCLUSION


This 2-year, double-blind randomised trial showed that among patients with a history of  H. pylori -negative idiopathic ulcer bleeding, recurrent bleeding rates were comparable between users of lansoprazole and famotidine, although a small difference in efficacy cannot be excluded.
TRIAL REGISTRATION NUMBER


NCT01180179; Results.",2020,Recurrent upper GI bleeding occurred in one patient receiving lansoprazole (duodenal ulcer) and three receiving famotidine (two gastric ulcers and one duodenal ulcer).,"['recurrent idiopathic gastroduodenal ulcer bleeding', '228 patients (114 patients in each study group', 'patients who rebled used aspirin, non-steroidal anti-inflammatory drugs or other antithrombotic drugs', 'Between 2010 and 2018', 'patients with a history of idiopathic bleeding ulcers', 'After ulcer healing', 'Patients with a history of  Helicobacter pylori -negative idiopathic bleeding ulcers']","['lansoprazole and famotidine', 'oral lansoprazole 30\u2009mg or famotidine', 'lansoprazole', 'proton pump inhibitor (lansoprazole', 'histamine 2 receptor antagonist (famotidine', 'famotidine']","['history of  H. pylori -negative idiopathic ulcer bleeding, recurrent bleeding rates', 'cumulative incidence of recurrent upper GI bleeding', 'Recurrent upper GI bleeding', 'recurrent upper GI bleeding']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0030920', 'cui_str': 'Gastroduodenal Ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0333291', 'cui_str': 'Bleeding ulcer (morphologic abnormality)'}]","[{'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C0015620', 'cui_str': 'Famotidine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1602204', 'cui_str': 'lansoprazole 30 MG [Prevacid]'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}]","[{'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0333291', 'cui_str': 'Bleeding ulcer (morphologic abnormality)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal hemorrhage (disorder)'}]",228.0,0.331017,Recurrent upper GI bleeding occurred in one patient receiving lansoprazole (duodenal ulcer) and three receiving famotidine (two gastric ulcers and one duodenal ulcer).,"[{'ForeName': 'Grace L H', 'Initials': 'GLH', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Louis H S', 'Initials': 'LHS', 'LastName': 'Lau', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Jessica Y L', 'Initials': 'JYL', 'LastName': 'Ching', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Yee-Kit', 'Initials': 'YK', 'LastName': 'Tse', 'Affiliation': 'Institute of Digestive Diseases, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Rachel H Y', 'Initials': 'RHY', 'LastName': 'Ling', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Vincent W S', 'Initials': 'VWS', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Philip W Y', 'Initials': 'PWY', 'LastName': 'Chiu', 'Affiliation': 'Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'James Y W', 'Initials': 'JYW', 'LastName': 'Lau', 'Affiliation': 'Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Francis K L', 'Initials': 'FKL', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China.'}]",Gut,['10.1136/gutjnl-2019-318715']
3082,31364415,A pilot clinical study of the neuromuscular blocker rocuronium to reduce the duration of ventilation after organophosphorus insecticide poisoning.,"Background:  A common manifestation of organophosphorus insecticide self-poisoning is prolonged respiratory failure due to neuromuscular junction dysfunction and likely nicotinic receptor overstimulation. We aimed at collecting preliminary data on whether addition of the competitive nicotinic antagonist rocuronium to standard early therapy might be clinically feasible and associated with reduced duration of ventilation. Methods:  A pilot three-arm dose-response phase II trial was set up to compare bolus doses of rocuronium bromide titrated to produce initial >95% or 50% inhibition of neuromuscular function, measured using acceleromyography, plus standard treatment, versus standard treatment alone. After attaining inhibition, patients receiving bolus rocuronium then received rocuronium infusions for a maximum of 120 h. Primary outcome was duration of intubation; secondary outcome was case fatality. Plasma butyrylcholinesterase activity was measured throughout the inpatient stay. Blood was analysed to confirm the organophosphorus insecticide ingested. Results:  Forty-five patients were randomised to receive: rocuronium to initially attain 95% inhibition (Roc>95,  n  = 15), rocuronium to initially attain 50% inhibition (Roc50,  n  = 14), or no rocuronium (control,  n  = 16). The most commonly ingested pesticide was profenofos (29/45, 64.4%). Butyrylcholinesterase activity remained severely inhibited for the duration of the study for most patients. Case fatality was 9/45 (20%) and similar across study arms: control 3/16 (18.8%), Roc50 4/14 (28.6%) and Roc>95 2/15 (13.3%) ( p  = .5842). When excluding patients who died, median [IQR] duration of intubation was significantly longer in the Roc50 (259.5 [176-385] h) and Roc>95 (226.8 [186-355] h) groups compared to controls (88.5 [47-160] h,  p  = .0162 and  p  = .0016, respectively). Conclusions:  In this pilot dose-response study, we found no evidence that rocuronium in addition to standard therapy reduced the duration of intubation. It is possible that it worsened neuromuscular junction function. Further clinical research, including testing of shorter duration regimens, needs to be performed before nicotinic antagonists can be used in the clinical management of OP poisoning.",2020,"Case fatality was 9/45 (20%) and similar across study arms: control 3/16 (18.8%), Roc50 4/14 (28.6%) and Roc>95 2/15 (13.3%) ( p  = .5842).","['after organophosphorus insecticide poisoning', 'Results:  Forty-five patients']","['rocuronium infusions', 'rocuronium bromide', 'rocuronium', 'rocuronium to initially attain 95% inhibition (Roc>95,  n \u2009=\u200915), rocuronium to initially attain 50% inhibition (Roc50,  n \u2009=\u200914), or no rocuronium', 'neuromuscular blocker rocuronium', 'competitive nicotinic antagonist rocuronium']","['duration of ventilation', 'duration of intubation', 'duration of intubation; secondary outcome was case fatality', 'died, median [IQR] duration of intubation', 'Case fatality', 'Butyrylcholinesterase activity', 'Plasma butyrylcholinesterase activity']","[{'cui': 'C0021576', 'cui_str': 'Insecticides'}, {'cui': 'C0032343', 'cui_str': 'Poisoning'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0069632', 'cui_str': 'rocuronium bromide'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1628982', 'cui_str': 'Percent inhibition'}, {'cui': 'C0027866', 'cui_str': 'Neuromuscular Blockers'}, {'cui': 'C0242956', 'cui_str': 'Nicotinic Antagonists'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0728810', 'cui_str': 'Pseudocholinesterase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",45.0,0.206977,"Case fatality was 9/45 (20%) and similar across study arms: control 3/16 (18.8%), Roc50 4/14 (28.6%) and Roc>95 2/15 (13.3%) ( p  = .5842).","[{'ForeName': 'Jeevan', 'Initials': 'J', 'LastName': 'Dhanarisi', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Fathima', 'Initials': 'F', 'LastName': 'Shihana', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Harju', 'Affiliation': 'VERIFIN, Finnish Institute for Verification of the Chemical Weapons Convention, Department of Chemistry, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Mohamed', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Vasundhara', 'Initials': 'V', 'LastName': 'Verma', 'Affiliation': 'Department of Pharmacology, Toxicology, & Therapeutics, University/BHF Centre for Cardiovascular Science, and Centre for Pesticide Suicide Prevention, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Seyed', 'Initials': 'S', 'LastName': 'Shahmy', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Vanninen', 'Affiliation': 'VERIFIN, Finnish Institute for Verification of the Chemical Weapons Convention, Department of Chemistry, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Kostiainen', 'Affiliation': 'VERIFIN, Finnish Institute for Verification of the Chemical Weapons Convention, Department of Chemistry, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Indika', 'Initials': 'I', 'LastName': 'Gawarammana', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eddleston', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}]","Clinical toxicology (Philadelphia, Pa.)",['10.1080/15563650.2019.1643467']
3083,31711990,The Impact of Gravity vs Suction-driven Therapeutic Thoracentesis on Pressure-related Complications: The GRAVITAS Multicenter Randomized Controlled Trial.,"BACKGROUND


Thoracentesis can be accomplished by active aspiration or drainage with gravity. This trial investigated whether gravity drainage could protect against negative pressure-related complications such as chest discomfort, re-expansion pulmonary edema, or pneumothorax compared with active aspiration.
METHODS


This prospective, multicenter, single-blind, randomized controlled trial allocated patients with large free-flowing effusions estimated ≥ 500 mL 1:1 to undergo active aspiration or gravity drainage. Patients rated chest discomfort on 100-mm visual analog scales prior to, during, and following drainage. Thoracentesis was halted at complete evacuation or for persistent chest discomfort, intractable cough, or other complication. The primary outcome was overall procedural chest discomfort scored 5 min following the procedure. Secondary outcomes included measures of discomfort and breathlessness through 48 h postprocedure.
RESULTS


A total of 142 patients were randomized to undergo treatment, with 140 in the final analysis. Groups did not differ for the primary outcome (mean visual analog scale score difference, 5.3 mm; 95% CI, -2.4 to 13.0; P = .17). Secondary outcomes of discomfort and dyspnea did not differ between groups. Comparable volumes were drained in both groups, but the procedure duration was significantly longer in the gravity arm (mean difference, 7.4 min; 95% CI, 10.2 to 4.6; P < .001). There were no serious complications.
CONCLUSIONS


Thoracentesis via active aspiration and gravity drainage are both safe and result in comparable levels of procedural comfort and dyspnea improvement. Active aspiration requires less total procedural time.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT03591952; URL: www.clinicaltrials.gov.",2020,"Groups did not differ for the primary outcome (mean VAS score difference 5.3 mm, 95% CI -2.4 to 13.0, p = 0.17).","['patients with large free-flowing effusions estimated ≥ 500 mL 1:1 to', 'One hundred forty-two patients were randomized with 140 in the final analysis']","['active aspiration or gravity drainage', 'Gravity versus Suction-driven Therapeutic Thoracentesis', 'gravity drainage']","['discomfort and breathlessness through 48 hours post-procedure', 'total procedural time', 'discomfort and dyspnea', 'overall procedural chest discomfort', 'Pressure-related Complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0013687', 'cui_str': 'Effusion (morphologic abnormality)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0189477', 'cui_str': 'Thoracocentesis'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0235710', 'cui_str': 'Chest discomfort (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",142.0,0.631435,"Groups did not differ for the primary outcome (mean VAS score difference 5.3 mm, 95% CI -2.4 to 13.0, p = 0.17).","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Lentz', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN; Department of Thoracic Surgery, Vanderbilt University School of Medicine, Nashville, TN; Department of Veterans Affairs Medical Center, Nashville, TN.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Shojaee', 'Affiliation': 'Division of Pulmonary Disease and Critical Care Medicine, Department of Medicine, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Horiana B', 'Initials': 'HB', 'LastName': 'Grosu', 'Affiliation': 'Department of Pulmonary Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Otis B', 'Initials': 'OB', 'LastName': 'Rickman', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN; Department of Thoracic Surgery, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Roller', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Jasleen K', 'Initials': 'JK', 'LastName': 'Pannu', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, The Ohio State University Wexner Medical Center, Columbus, OH.'}, {'ForeName': 'Zachary S', 'Initials': 'ZS', 'LastName': 'DePew', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Creighton University School of Medicine, Omaha, NE.'}, {'ForeName': 'Labib G', 'Initials': 'LG', 'LastName': 'Debiane', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Cicenia', 'Affiliation': 'Department of Pulmonary Medicine, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Akulian', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Charla', 'Initials': 'C', 'LastName': 'Walston', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN; Department of Thoracic Surgery, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Trinidad M', 'Initials': 'TM', 'LastName': 'Sanchez', 'Affiliation': 'Division of Pulmonary Disease and Critical Care Medicine, Department of Medicine, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Davidson', 'Affiliation': 'Division of Pulmonary Disease and Critical Care Medicine, Department of Medicine, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Jagan', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Creighton University School of Medicine, Omaha, NE.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Ahmad', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gilbert', 'Affiliation': 'Division of Thoracic Surgery and Interventional Pulmonology, Swedish Cancer Institute, Seattle, WA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Huggins', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Light', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Lonny', 'Initials': 'L', 'LastName': 'Yarmus', 'Affiliation': 'Section of Interventional Pulmonology, Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Feller-Kopman', 'Affiliation': 'Section of Interventional Pulmonology, Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Section of Interventional Pulmonology, Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Najib M', 'Initials': 'NM', 'LastName': 'Rahman', 'Affiliation': 'Oxford Centre for Respiratory Medicine, Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK; Oxford NIHR Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Maldonado', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN; Department of Thoracic Surgery, Vanderbilt University School of Medicine, Nashville, TN. Electronic address: fabien.maldonado@vumc.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chest,['10.1016/j.chest.2019.10.025']
3084,31094352,"Development of the Top Tips Habit-Based Weight Loss App and Preliminary Indications of Its Usage, Effectiveness, and Acceptability: Mixed-Methods Pilot Study.","BACKGROUND


The Ten Top Tips (10TT) is an intervention based on the habit formation theory that promotes a set of weight management behaviors alongside advice about repetition in a consistent context. Overall, 3 studies have demonstrated that the 10TT can support individuals to lose weight when delivered in a leaflet format. Delivery of 10TT via new technology such as a mobile app could potentially improve its effectiveness and make it more convenient, appealing, and wide reaching.
OBJECTIVE


This study aimed to provide preliminary indications of the usage, effectiveness, and acceptability of an Android app of the 10TT intervention (Top Tips only app) and a second version including self-regulatory strategies for dealing with tempting foods (Top Tips plus app).
METHODS


The 3-month pilot randomized adults with overweight or obesity to (1) Top Tips only app, (2) Top Tips plus app, or (3) waiting list condition. Automated data from app users were collected. Validated questionnaires assessed self-regulatory skills, weight loss (kg), and behaviors at baseline and 3 months. Users' feedback on their experience using the app was assessed using open questions.
RESULTS


A total of 81 participants took part in the pilot; 28 participants were randomized to the Top Tips only app, 27 to the Top Tips plus app, and 26 to the waiting list condition. On average, participants viewed a mean of 43.4 (SD 66.9) screens during a mean of 24.5 (SD 44.07) log-ins and used the app for 124.2 (SD 240.2) min over the 3-month period. Participants randomized to the Top Tips only app reported the greatest improvement in self-regulatory skills (mean 0.59, SD 1.0), weight loss (mean 4.5 kg, SD 5.2), and adherence to the target behaviors (mean 0.59, SD 0.49) compared with the Top Tips plus (mean self-regulation  0.15, SD 0.42; mean weight  -1.9, SD 3.9; and mean behaviors  0.29, SD 0.29) and waiting list condition (mean self-regulation  -0.02, SD 0.29; mean weight  -0.01, SD 0.51; and mean behaviors  0.08, SD 0.38). Participants who reported the largest improvements, on average, viewed pages 2 to 3 times more, had 2 to 3 times more log-ins, logged their weight 2 to 3 times more, and achieved the tips more than those who reported smaller changes in these outcomes. According to users' feedback, engagement with the app could be increased by making the app more interactive and allowing more tailoring.
CONCLUSIONS


This study suggests that the Top Tips app could potentially be a useful intervention for promoting eating self-regulatory skills, weight loss, and weight management behaviors among adults with overweight or obesity. Future research should develop the app further based on user feedback and test it in larger sample sizes.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN10470937; http://www.isrctn.com/ISRCTN10470937 (Archived by Webcite at http://www.webcitation.org/76j6rQibI).",2019,"Participants randomized to the Top Tips only app reported the greatest improvement in self-regulatory skills (mean 0.59, SD 1.0), weight loss (mean 4.5 kg, SD 5.2), and adherence to the target behaviors (mean 0.59, SD 0.49) compared with the Top Tips plus (mean self-regulation  0.15, SD 0.42; mean weight  -1.9, SD 3.9; and mean behaviors  0.29, SD 0.29) and waiting list condition (mean self-regulation  -0.02, SD 0.29; mean weight  -0.01, SD 0.51; and mean behaviors  0.08, SD 0.38).","['adults with overweight or obesity to (1) Top Tips only app, (2) Top Tips plus app, or (3) waiting list condition', '81 participants took part in the pilot; 28 participants', 'adults with overweight or obesity']",[],"['adherence to the target behaviors', 'weight loss', 'waiting list condition', 'self-regulatory skills', 'Validated questionnaires assessed self-regulatory skills, weight loss (kg), and behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}]",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",81.0,0.0929207,"Participants randomized to the Top Tips only app reported the greatest improvement in self-regulatory skills (mean 0.59, SD 1.0), weight loss (mean 4.5 kg, SD 5.2), and adherence to the target behaviors (mean 0.59, SD 0.49) compared with the Top Tips plus (mean self-regulation  0.15, SD 0.42; mean weight  -1.9, SD 3.9; and mean behaviors  0.29, SD 0.29) and waiting list condition (mean self-regulation  -0.02, SD 0.29; mean weight  -0.01, SD 0.51; and mean behaviors  0.08, SD 0.38).","[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Kliemann', 'Affiliation': 'Nutritional Epidemiology Group, International Agency for Research on Cancer, World Health Organization, Lyon, France.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Croker', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Johnson', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, United Kingdom.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Beeken', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, United Kingdom.'}]",JMIR mHealth and uHealth,['10.2196/12326']
3085,31452311,Haemoconcentration during treatment of acute heart failure with cardiorenal syndrome: from the CARRESS-HF trial.,,2019,,['acute heart failure with cardiorenal syndrome'],['Haemoconcentration'],[],"[{'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C2242703', 'cui_str': 'Renocardiac Syndrome'}]","[{'cui': 'C0854379', 'cui_str': 'Haemoconcentration'}]",[],,0.0425089,,"[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Blumer', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Jie-Lena', 'Initials': 'JL', 'LastName': 'Sun', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Bart', 'Affiliation': 'Division of Cardiology, Hennepin County Medical Center, Minneapolis, MN, USA.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Division of Cardiology, The Permanente Medical Group, San Francisco, CA, USA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Marat', 'Initials': 'M', 'LastName': 'Fudim', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}]",European journal of heart failure,['10.1002/ejhf.1592']
3086,31058986,Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial.,"Importance


The US Food and Drug Administration (FDA) has provided guidance that sunscreen active ingredients with systemic absorption greater than 0.5 ng/mL or with safety concerns should undergo nonclinical toxicology assessment including systemic carcinogenicity and additional developmental and reproductive studies.
Objective


To determine whether the active ingredients (avobenzone, oxybenzone, octocrylene, and ecamsule) of 4 commercially available sunscreens are absorbed into systemic circulation.
Design, Setting, and Participants


Randomized clinical trial conducted at a phase 1 clinical pharmacology unit in the United States and enrolling 24 healthy volunteers. Enrollment started in July 2018 and ended in August 2018.
Interventions


Participants were randomized to 1 of 4 sunscreens: spray 1 (n = 6 participants), spray 2 (n = 6), a lotion (n = 6), and a cream (n = 6). Two milligrams of sunscreen per 1 cm2 was applied to 75% of body surface area 4 times per day for 4 days, and 30 blood samples were collected over 7 days from each participant.
Main Outcomes and Measures


The primary outcome was the maximum plasma concentration of avobenzone. Secondary outcomes were the maximum plasma concentrations of oxybenzone, octocrylene, and ecamsule.
Results


Among 24 participants randomized (mean age, 35.5 [SD, 1.5] years; 12 (50%] women; 14 [58%] black or African American; 14 [58%]), 23 (96%) completed the trial. For avobenzone, geometric mean maximum plasma concentrations were 4.0 ng/mL (coefficient of variation, 6.9%) for spray 1; 3.4 ng/mL (coefficient of variation, 77.3%) for spray 2; 4.3 ng/mL (coefficient of variation, 46.1%) for lotion; and 1.8 ng/mL (coefficient of variation, 32.1%). For oxybenzone, the corresponding values were 209.6 ng/mL (66.8%) for spray 1, 194.9 ng/mL (52.4%) for spray 2, and 169.3 ng/mL (44.5%) for lotion; for octocrylene, 2.9 ng/mL (102%) for spray 1, 7.8 ng/mL (113.3%) for spray 2, 5.7 ng/mL (66.3%) for lotion, and 5.7 ng/mL (47.1%) for cream; and for ecamsule, 1.5 ng/mL (166.1%) for cream. Systemic concentrations greater than 0.5 ng/mL were reached for all 4 products after 4 applications on day 1. The most common adverse event was rash, which developed in 1 participant with each sunscreen.
Conclusions and Relevance


In this preliminary study involving healthy volunteers, application of 4 commercially available sunscreens under maximal use conditions resulted in plasma concentrations that exceeded the threshold established by the FDA for potentially waiving some nonclinical toxicology studies for sunscreens. The systemic absorption of sunscreen ingredients supports the need for further studies to determine the clinical significance of these findings. These results do not indicate that individuals should refrain from the use of sunscreen.
Trial Registration


ClinicalTrials.gov Identifier: NCT03582215.",2019,Systemic concentrations greater than 0.5 ng/mL were reached for all 4 products after 4 applications on day 1.,"['24 healthy volunteers', 'healthy volunteers', '24 participants randomized (mean age, 35.5 [SD, 1.5] years; 12 (50%] women; 14 [58%] black or African American; 14 [58%]), 23 (96%) completed the trial']","['active ingredients (avobenzone, oxybenzone, octocrylene, and ecamsule', 'US Food and Drug Administration (FDA', 'Sunscreen Application']","['Systemic concentrations', 'Plasma Concentration of Sunscreen Active Ingredients', 'maximum plasma concentration of avobenzone', 'maximum plasma concentrations of oxybenzone, octocrylene, and ecamsule', 'geometric mean maximum plasma concentrations']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0097513', 'cui_str': 'avobenzone'}, {'cui': 'C0069803', 'cui_str': 'oxybenzone'}, {'cui': 'C0257715', 'cui_str': 'octocrylene'}, {'cui': 'C1721194', 'cui_str': 'Ecamsule'}, {'cui': 'C0041714', 'cui_str': 'Food and Drug Administration'}, {'cui': 'C0038818', 'cui_str': 'Sunscreens'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0038818', 'cui_str': 'Sunscreens'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0097513', 'cui_str': 'avobenzone'}, {'cui': 'C0069803', 'cui_str': 'oxybenzone'}, {'cui': 'C0257715', 'cui_str': 'octocrylene'}, {'cui': 'C1721194', 'cui_str': 'Ecamsule'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",24.0,0.345029,Systemic concentrations greater than 0.5 ng/mL were reached for all 4 products after 4 applications on day 1.,"[{'ForeName': 'Murali K', 'Initials': 'MK', 'LastName': 'Matta', 'Affiliation': 'Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Robbert', 'Initials': 'R', 'LastName': 'Zusterzeel', 'Affiliation': 'Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Nageswara R', 'Initials': 'NR', 'LastName': 'Pilli', 'Affiliation': 'Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Donna A', 'Initials': 'DA', 'LastName': 'Volpe', 'Affiliation': 'Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Jeffry', 'Initials': 'J', 'LastName': 'Florian', 'Affiliation': 'Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Oh', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Bashaw', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Issam', 'Initials': 'I', 'LastName': 'Zineh', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Sanabria', 'Affiliation': 'Spaulding Clinical Research, West Bend, Wisconsin.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kemp', 'Affiliation': 'Spaulding Clinical Research, West Bend, Wisconsin.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Godfrey', 'Affiliation': 'Spaulding Clinical Research, West Bend, Wisconsin.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Adah', 'Affiliation': 'Division of Nonprescription Drug Products, Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Coelho', 'Affiliation': 'Division of Nonprescription Drug Products, Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Lesley-Anne', 'Initials': 'LA', 'LastName': 'Furlong', 'Affiliation': 'Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ganley', 'Affiliation': 'Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Michele', 'Affiliation': 'Division of Nonprescription Drug Products, Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Strauss', 'Affiliation': 'Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}]",JAMA,['10.1001/jama.2019.5586']
3087,30473097,"LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept.","OBJECTIVE


A novel dual GIP and GLP-1 receptor agonist, LY3298176, was developed to determine whether the metabolic action of GIP adds to the established clinical benefits of selective GLP-1 receptor agonists in type 2 diabetes mellitus (T2DM).
METHODS


LY3298176 is a fatty acid modified peptide with dual GIP and GLP-1 receptor agonist activity designed for once-weekly subcutaneous administration. LY3298176 was characterised in vitro, using signaling and functional assays in cell lines expressing recombinant or endogenous incretin receptors, and in vivo using body weight, food intake, insulin secretion and glycemic profiles in mice. A Phase 1, randomised, placebo-controlled, double-blind study was comprised of three parts: a single-ascending dose (SAD; doses 0.25-8 mg) and 4-week multiple-ascending dose (MAD; doses 0.5-10 mg) studies in healthy subjects (HS), followed by a 4-week multiple-dose Phase 1 b proof-of-concept (POC; doses 0.5-15 mg) in patients with T2DM (ClinicalTrials.gov no. NCT02759107). Doses higher than 5 mg were attained by titration, dulaglutide (DU) was used as a positive control. The primary objective was to investigate safety and tolerability of LY3298176.
RESULTS


LY3298176 activated both GIP and GLP-1 receptor signaling in vitro and showed glucose-dependent insulin secretion and improved glucose tolerance by acting on both GIP and GLP-1 receptors in mice. With chronic administration to mice, LY3298176 potently decreased body weight and food intake; these effects were significantly greater than the effects of a GLP-1 receptor agonist. A total of 142 human subjects received at least 1 dose of LY3298176, dulaglutide, or placebo. The PK profile of LY3298176 was investigated over a wide dose range (0.25-15 mg) and supports once-weekly administration. In the Phase 1 b trial of diabetic subjects, LY3298176 doses of 10 mg and 15 mg significantly reduced fasting serum glucose compared to placebo (least square mean [LSM] difference [95% CI]: -49.12 mg/dL [-78.14, -20.12] and -43.15 mg/dL [-73.06, -13.21], respectively). Reductions in body weight were significantly greater with the LY3298176 1.5 mg, 4.5 mg and 10 mg doses versus placebo in MAD HS (LSM difference [95% CI]: -1.75 kg [-3.38, -0.12], -5.09 kg [-6.72, -3.46] and -4.61 kg [-6.21, -3.01], respectively) and doses of 10 mg and 15 mg had a relevant effect in T2DM patients (LSM difference [95% CI]: -2.62 kg [-3.79, -1.45] and -2.07 kg [-3.25, -0.88], respectively. The most frequent side effects reported with LY3298176 were gastrointestinal (vomiting, nausea, decreased appetite, diarrhoea, and abdominal distension) in both HS and patients with T2DM; all were dose-dependent and considered mild to moderate in severity.
CONCLUSIONS


Based on these results, the pharmacology of LY3298176 translates from preclinical to clinical studies. LY3298176 has the potential to deliver clinically meaningful improvement in glycaemic control and body weight. The data warrant further clinical evaluation of LY3298176 for the treatment of T2DM and potentially obesity.",2018,"The most frequent side effects reported with LY3298176 were gastrointestinal (vomiting, nausea, decreased appetite, diarrhoea, and abdominal distension) in both HS and patients with T2DM; all were dose-dependent and considered mild to moderate in severity.
","['142 human subjects', 'type 2 diabetes mellitus']","['placebo', 'LY3298176, dulaglutide, or placebo', 'single-ascending dose (SAD; doses 0.25-8\xa0mg) and 4-week multiple-ascending dose (MAD; doses 0.5-10\xa0mg) studies in healthy subjects (HS), followed by a 4-week multiple-dose Phase 1\xa0b proof-of-concept (POC; doses 0.5-15\xa0mg) in patients with T2DM (ClinicalTrials.gov', 'GLP-1 receptor agonist', 'dL']","['glucose tolerance', 'body weight and food intake', 'safety and tolerability', 'fasting serum glucose', 'gastrointestinal (vomiting, nausea, decreased appetite, diarrhoea, and abdominal distension', 'body weight']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}]",142.0,0.0558784,"The most frequent side effects reported with LY3298176 were gastrointestinal (vomiting, nausea, decreased appetite, diarrhoea, and abdominal distension) in both HS and patients with T2DM; all were dose-dependent and considered mild to moderate in severity.
","[{'ForeName': 'Tamer', 'Initials': 'T', 'LastName': 'Coskun', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Kyle W', 'Initials': 'KW', 'LastName': 'Sloop', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Loghin', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Alsina-Fernandez', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Urva', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Krister B', 'Initials': 'KB', 'LastName': 'Bokvist', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Xuewei', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Briere', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Over', 'Initials': 'O', 'LastName': 'Cabrera', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Roell', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Kuchibhotla', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Julie S', 'Initials': 'JS', 'LastName': 'Moyers', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Charles T', 'Initials': 'CT', 'LastName': 'Benson', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Gimeno', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': ""D'Alessio"", 'Affiliation': 'Division of Endocrinology, Metabolism, and Nutrition, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Haupt', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA. Electronic address: haupt_axel@lilly.com.'}]",Molecular metabolism,['10.1016/j.molmet.2018.09.009']
3088,30583082,"No effect of monthly supplementation with 12000 IU, 24000 IU or 48000 IU vitamin D3 for one year on muscle function: The vitamin D in older people study.","Vitamin D plays a role in muscle function through genomic and non-genomic processes. The objective of this RCT was to determine the effect of monthly supplemental vitamin D 3  onmuscle function in 70+ years old adults. Participants (n = 379) were randomized to receive, 12,000 IU, 24,000 IU or 48,000 IU of vitamin D 3  monthly for 12 months. Standardized Hand Grip Strength (GS) and Timed-Up and Go (TUG) were measured before and after vitamin D 3  supplementation. Fasting total plasma 25 hydroxyvitamin D (25OHD) and Parathyroid Hormone (PTH) concentrations were measured by Liquid Chromatography Tandem Mass Spectrometry (LC-MSMS) and immunoassay, respectively. Baseline plasma 25OHD concentrations were 41.3 (SD 19.9), 39.5 (SD 20.6), 38.9 (SD 19.7) nmol/L; GS values were 28.5 (SD 13.4), 28.8 (SD 13.0) and 28.1 (SD 12.1) kg and TUG test values were 10.8 (SD 2.5), 11.6 (SD 2.9) and 11.9 (SD 3.6) s for the 12,000 IU, 24,000 IU and 48,000 IU dose groups, respectively. Baseline plasma 25OHD concentration < 25 nmol/L was associated with lower GS (P = 0.003). Post-interventional plasma 25OHD concentrations increased to 55.9 (SD 15.6), 64.6 (SD15.3) and 79.0 (SD 15.1) nmol/L in the 12,000 IU, 24,000 IU and 48,000 IU dose groups, respectively and there was a significant dose-related response in post-interventional plasma 25OHD concentration (p<0.0001). Post-interventional GS values were 24.1 (SD 10.1), 26.2 (SD10.6) and 25.7 (SD 9.4) kg and TUG test values were 11.5 (SD 2.6), 12.0 (SD 3.7) and 11.9 (SD 3.2) s for 12,000 IU, 24,000 IU and 48,000 IU dose groups, respectively. The change (Δ) in GS and TUG from pre to post-intervention was not different between treatment groups before and after the adjustment for confounders, suggesting no effect of the intervention. Plasma 25OHD concentration was not associated with GS and TUG test after supplementation. In conclusion, plasma 25OHD concentration < 25 nmol/L was associated with lower GS at baseline. However, monthly vitamin D 3  supplementation with 12,000 IU, 24,000 IU and 48,000 IU, for 12 months had no effect on muscle function in older adults aged 70+ years. Trial Registration : EudraCT 2011-004890-10 and ISRCTN35648481.",2019,Baseline plasma 25OHD concentration < 25 nmol/L was associated with lower GS (P = 0.003).,"['Participants (n\u2009=\u2009379', 'older people study', '70+ years old adults', 'older adults aged 70+ years']","['vitamin D', 'supplemental vitamin D', 'Vitamin D', 'vitamin D3']","['Post-interventional plasma 25OHD concentrations', 'Standardized Hand Grip Strength (GS) and Timed-Up and Go (TUG', 'Baseline plasma 25OHD concentrations', 'Baseline plasma 25OHD concentration', 'plasma 25OHD concentration', 'Fasting total plasma 25 hydroxyvitamin D (25OHD) and Parathyroid Hormone (PTH) concentrations', 'Plasma 25OHD concentration', 'muscle function', 'Post-interventional GS values']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.388032,Baseline plasma 25OHD concentration < 25 nmol/L was associated with lower GS (P = 0.003).,"[{'ForeName': 'R M T K', 'Initials': 'RMTK', 'LastName': 'Ranathunga', 'Affiliation': 'Human Nutrition Research Centre, Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Framlington Place, Newcastle upon Tyne, UK, NE2 4HH; Department of Applied Nutrition, Wayamba University of Sri Lanka, Faculty of Livestock, Fisheries and Nutrition, Makandura, Gonawila, 60170, Sri Lanka.'}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Hill', 'Affiliation': 'Human Nutrition Research Centre, Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Framlington Place, Newcastle upon Tyne, UK, NE2 4HH.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Framlington Place, Newcastle upon Tyne, UK, NE2 4HH.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Francis', 'Affiliation': 'Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Framlington Place, Newcastle upon Tyne, UK, NE2 4HH.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Prentice', 'Affiliation': 'MRC Elsie Widdowson Laboratory, Cambridge, UK, CB1 9NL.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Schoenmakers', 'Affiliation': 'MRC Elsie Widdowson Laboratory, Cambridge, UK, CB1 9NL; Norwich Medical School, University of East Anglia, Norwich, UK, NR4 7TJ.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Aspray', 'Affiliation': 'Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Framlington Place, Newcastle upon Tyne, UK, NE2 4HH; NIHR Newcastle Biomedical Research Centre, Campus for Ageing and Vitality, Newcastle upon Tyne, UK, NE4 5PL. Electronic address: terry.aspray@newcastle.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2018.12.008']
3089,32073202,Therapeutic psychological and biological responses to mindfulness-based art therapy.,"Stress and anxiety pose a threat to college students' academic performance as well as their long-term mental and physical health, but the time constraints of a rigorous academic schedule make it difficult to offer even brief mental health interventions. A convenience sample of full-time students at a public university was recruited for a 5-week study conducted mostly using an online platform. Participants were randomly assigned to a Mindfulness-Based Art Therapy (MBAT) intervention or a Neutral Clay Task (NCT). Anxiety, perceived stress, and salivary cortisol outcomes were measured. A total of n = 77 participants completed the study. The MBAT group experienced significant reductions in anxiety and perceived stress compared to the NCT group. Significant reductions in salivary cortisol were observed, but only time could be identified as a confounding variable. Art making alone is not enough to induce significant positive responses, but this study suggests MBAT can, and that an online intervention could offer feasible and accessible mental health services on college campuses. Further refinement of biological data collection and analysis is needed to determine what the mediating effects MBAT could have, if any, at the molecular level.",2020,The MBAT group experienced significant reductions in anxiety and perceived stress compared to the NCT group.,"['A total of n\xa0=\xa077 participants completed the study', 'A convenience sample of full-time students at a public university were recruited for a five-week study conducted mostly using an online platform']","['MBAT', 'Mindfulness-Based Art Therapy (MBAT) intervention or a Neutral Clay Task (NCT', 'NCT']","['Anxiety, perceived stress, and salivary cortisol outcomes', 'anxiety and perceived stress', 'salivary cortisol']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1446397', 'cui_str': 'Student in full time education'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0003827', 'cui_str': 'Art Therapy'}, {'cui': 'C0055863'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",77.0,0.0457394,The MBAT group experienced significant reductions in anxiety and perceived stress compared to the NCT group.,"[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Beerse', 'Affiliation': 'Department of Art Education, Florida State University, Tallahassee, Florida.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Van Lith', 'Affiliation': 'Department of Art Education, Florida State University, Tallahassee, Florida.'}, {'ForeName': 'Gregg', 'Initials': 'G', 'LastName': 'Stanwood', 'Affiliation': 'Department of Biomedical Sciences, Florida State University, Tallahassee, Florida.'}]",Stress and health : journal of the International Society for the Investigation of Stress,['10.1002/smi.2937']
3090,32144189,Exercise intervention improves quality of life in older adults after myocardial infarction: randomised clinical trial.,"OBJECTIVE


To establish the benefits of an early, tailored and low-cost exercise intervention in older patients hospitalised for acute coronary syndrome (ACS).
METHODS


The study was a multicentre, randomised assessment of an exercise intervention in patients with ACS ≥70 years with reduced physical performance (as defined by the short physical performance battery (SPPB), value 4-9). The exercise intervention included four supervised sessions (1, 2, 3, 4 months after discharge) and home-based exercises. The control group attended a health education programme only. The outcomes were the 6-month and 1-year effects on physical performance, daily activities, anxiety/depression and quality of life. Finally, 1-year occurrence of adverse events was recorded.
RESULTS


Overall, 235 patients with ACS (median age 76 (73-81) years) were randomised 1 month after ACS. Exercise and control groups were well balanced. Exercise intervention improved 6-month and 1-year grip strength and gait speed. Exercise intervention was associated with a better quality of life (as measured by EuroQol-visual analogue scale at 6 months 80 (70-90) vs 70 (50-80) points, p<0.001 and at 1 year 75 (70-87) vs 65 (50-80) points, p<0.001) and with a reduced perception of anxiety and/or depression (6 months: 21% vs 42%, p=0.001; 1 year 32% vs 47%, p=0.03). The occurrence of cardiac death and hospitalisation for cardiac cause was lower in the intervention group (7.5% vs 17%, p=0.04).
CONCLUSIONS


The proposed early, tailored, low-cost exercise intervention improves mobility, daily activities, quality of life and outcomes in older patients with ACS. Larger studies are needed to confirm the clinical benefit.
TRIAL REGISTRATION NUMBER


NCT03021044.",2020,"Exercise intervention was associated with a better quality of life (as measured by EuroQol-visual analogue scale at 6 months 80 (70-90) vs 70 (50-80) points, p<0.001 and at 1 year 75 (70-87) vs 65 (50-80) points, p<0.001) and with a reduced perception of anxiety and/or depression (6 months: 21% vs 42%, p=0.001; 1 year 32% vs 47%, p=0.03).","['older patients with ACS', 'older adults after myocardial infarction', 'older patients hospitalised for acute coronary syndrome (ACS', 'patients with ACS ≥70 years with reduced physical performance (as defined by the short physical performance battery (SPPB), value 4-9', '235 patients with ACS (median age 76 (73-81) years']","['health education programme only', 'tailored and low-cost exercise intervention', 'Exercise intervention', 'exercise intervention', 'low-cost exercise intervention']","['EuroQol-visual analogue scale', 'quality of life', 'physical performance, daily activities, anxiety/depression and quality of life', '6-month and 1-year grip strength and gait speed', 'mobility, daily activities, quality of life and outcomes', '1-year occurrence of adverse events', 'reduced perception of anxiety and/or depression', 'occurrence of cardiac death and hospitalisation for cardiac cause']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C2607857'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0018701'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0034380'}, {'cui': 'C2607857'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",235.0,0.119955,"Exercise intervention was associated with a better quality of life (as measured by EuroQol-visual analogue scale at 6 months 80 (70-90) vs 70 (50-80) points, p<0.001 and at 1 year 75 (70-87) vs 65 (50-80) points, p<0.001) and with a reduced perception of anxiety and/or depression (6 months: 21% vs 42%, p=0.001; 1 year 32% vs 47%, p=0.03).","[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campo', 'Affiliation': 'Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy cmpglc@unife.it.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Tonet', 'Affiliation': 'Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Chiaranda', 'Affiliation': 'Department of Public Health, AUSL Piacenza, and Sport Medicine Service, Piacenza, Italy.'}, {'ForeName': 'Gianluigi', 'Initials': 'G', 'LastName': 'Sella', 'Affiliation': 'Sports Medicine Center, AUSL Ravenna, Ravenna, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Maietti', 'Affiliation': 'Department of Medical Science, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Bugani', 'Affiliation': 'Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Vitali', 'Affiliation': 'Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Serenelli', 'Affiliation': 'Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Mazzoni', 'Affiliation': 'Public Health Department, Azienda USL di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Ruggiero', 'Affiliation': 'Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Villani', 'Affiliation': 'Cardiology Unit, Ospedale S, Giovanni da Saliceto, Piacenza, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Biscaglia', 'Affiliation': 'Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Pavasini', 'Affiliation': 'Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rubboli', 'Affiliation': 'Sports Medicine Center, AUSL Ravenna, Ravenna, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Campana', 'Affiliation': 'Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Caglioni', 'Affiliation': 'Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Volpato', 'Affiliation': 'Department of Medical Science, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Myers', 'Affiliation': 'School of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Grazzi', 'Affiliation': 'Public Health Department, Azienda USL di Ferrara, Ferrara, Italy.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2019-316349']
3091,31682466,Comparing psoriasis advertisement methods with patient willingness to initiate treatment.,"Background:  Many patients with psoriasis struggle with taking biologic agents. The way in which providers present medications could enhance treatment adherence. Objectives:  To determine how fear appeals, personal appeals, and social appeals influence psoriasis patients' willingness to use a biologic. Methods:  A randomized online survey study was used to assess subjects with a self-reported diagnosis of psoriasis and their willingness to initiate treatment. Subjects were randomized in a 1:1:1 ratio to receive an online survey with the following emotional appeals: social, fear, or personal ( n  = 315). Subject-reported willingness to take treatment was recorded on a 10-point Likert scale and analyzed via single-factor ANOVA, two-group t-tests, chi-squared analysis, and multiple linear regression analysis. Results:  A total of 315 subjects with a reported diagnosis of psoriasis completed the survey. Patient demographic information includes the following: mean age of 35 years ± 11.2; 67% female. Compared to subjects presented with a social appeal ( M  = 6.2, SD = 2.9), subjects presented with a fear appeal ( M  = 7.1, SD = 2.5,  p  = .01) and personal appeal ( M  = 7.0, SD = 2.7,  p  = .03) reported a greater average willingness to take treatment. Conclusions:  Presenting biologic agents using fear or personal appeals may be a simple and effective technique to improve patients' willingness to take treatment.",2020,"Compared to subjects presented with a social appeal (M = 6.2, SD =2.9), subjects presented with a fear appeal (M = 7.1, SD =2.5, p = 0.01) and personal appeal (M = 7.0, SD =2.7, p = 0.03) reported a greater average willingness to take treatment.","['315 subjects with a reported diagnosis of psoriasis completed the survey', ' mean age of 35 years ±11.2; 67% female', 'subjects with a self-reported diagnosis of psoriasis and their willingness to initiate treatment', 'patients with psoriasis struggle with taking biologic agents']","['online survey with the following emotional appeals: social, fear, or personal', ' ']",[],"[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0005515', 'cui_str': 'Biological Agents'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",[],315.0,0.0190185,"Compared to subjects presented with a social appeal (M = 6.2, SD =2.9), subjects presented with a fear appeal (M = 7.1, SD =2.5, p = 0.01) and personal appeal (M = 7.0, SD =2.7, p = 0.03) reported a greater average willingness to take treatment.","[{'ForeName': 'Jeremy K', 'Initials': 'JK', 'LastName': 'Bray', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Cline', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Masicampo', 'Affiliation': 'Department of Psychology, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Kammrath', 'Affiliation': 'Department of Psychology, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Feldman', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1688235']
3092,31283365,"Effects of Yoga Versus Sham Yoga on Oxidative Stress, Glycemic Status, and Anthropometry in Type 2 Diabetes Mellitus: A Single-Blinded Randomized Pilot Study.","Studies have shown a beneficial role of yoga in tre a t i n g type 2 diabetes mellitus. The present study proceeds in the field by providing an active control. We aimed to evaluate the effect of 3 months of yoga on oxidative stress, glycemic status, and anthropometry in type 2 diabetes mellitus. Forty participants were randomized to receive either yoga (n = 20) or sham yoga (n = 20) as a control. Yoga included postures and breathing exercises, and nonaerobic stretching exercise comprised the control. Significant within-group differences in malondialdehyde, vitamin C, superoxide dismutase, fasting blood glucose, glycosylated hemoglobin, body mass index, waist circumference, and blood pressure were evident in both groups. Yoga participants had significantly greater improvement in reduced glutathione compared to controls. No significant differences between groups were observed in any other outcome variables. Yoga and sham yoga had identical effects on oxidative stress, glycemic status, and anthropometry in type 2 diabetes mellitus. Levels of reduced glutathione improved only in the yoga group. This research needs to be confirmed by larger and sufficiently powered studies.",2020,"Significant within-group differences in malondialdehyde, vitamin C, superoxide dismutase, fasting blood glucose, glycosylated hemoglobin, body mass index, waist circumference, and blood pressure were evident in both groups.","['type 2 diabetes mellitus', 'Type 2 Diabetes Mellitus', 'Forty participants']","['Yoga Versus Sham Yoga', 'yoga ( n  = 20) or sham yoga', 'Yoga and sham yoga', 'Yoga included postures and breathing exercises, and nonaerobic stretching exercise comprised the control']","['Levels of reduced glutathione', 'malondialdehyde, vitamin C, superoxide dismutase, fasting blood glucose, glycosylated hemoglobin, body mass index, waist circumference, and blood pressure', 'Oxidative Stress, Glycemic Status, and Anthropometry', 'reduced glutathione', 'oxidative stress, glycemic status, and anthropometry']","[{'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0006155', 'cui_str': 'Respiratory Muscle Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}]",40.0,0.0831909,"Significant within-group differences in malondialdehyde, vitamin C, superoxide dismutase, fasting blood glucose, glycosylated hemoglobin, body mass index, waist circumference, and blood pressure were evident in both groups.","[{'ForeName': 'Shreelaxmi V', 'Initials': 'SV', 'LastName': 'Hegde', 'Affiliation': 'Department of Biochemistry, Srinivas Institute of Medical Science and Research Centre, Mangalore; and Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka, India.'}, {'ForeName': 'Prabha', 'Initials': 'P', 'LastName': 'Adhikari', 'Affiliation': 'Department of Geriatric Medicine, Yenepoya Medical College, Yenepoya University, Mangalore, Karnataka, India.'}, {'ForeName': 'Shashidhar M', 'Initials': 'SM', 'LastName': 'Kotian', 'Affiliation': 'Department of Community Medicine, Kasturba Medical College, Mangalore; and Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Shastry', 'Affiliation': 'Department of Pharmacology, Kasturba Medical College, Mangalore; and Manipal Academy of Higher Education, Manipal, Karnataka, India.'}]",International journal of yoga therapy,['10.17761/D-18-2020-00018']
3093,31497674,Study protocol: Randomized controlled trial of web-based decision support tools for high-risk women and healthcare providers to increase breast cancer chemoprevention.,"Background


Chemoprevention using selective estrogen receptor modulators and aromatase inhibitors has been shown to reduce invasive breast cancer incidence in high-risk women. Despite this evidence, few high-risk women who are eligible for chemoprevention utilize it as a risk-reducing strategy. Reasons for low uptake include inadequate knowledge about chemoprevention among patients and healthcare providers, concerns about side effects, time constraints during the clinical encounter, and competing comorbidities.
Methods/design


We describe the study design of a randomized controlled trial examining the effect of two web-based decision support tools on chemoprevention decision antecedents and quality, referral for specialized counseling, and chemoprevention uptake among women at an increased risk for breast cancer. The trial is being conducted at a large, urban medical center. A total of 300 patients and 50 healthcare providers will be recruited and randomized to standard educational materials alone or in combination with the decision support tools. Patient reported outcomes will be assessed at baseline, one and six months after randomization, and after their clinic visit with their healthcare provider.
Discussion


We are conducting this trial to provide evidence on how best to support personalized breast cancer risk assessment and informed and shared decision-making for chemoprevention. We propose to integrate the decision support tools into clinical workflow, which can potentially expand quality decision-making and chemoprevention uptake.
Trial registration


NCT03069742.",2019,"We describe the study design of a randomized controlled trial examining the effect of two web-based decision support tools on chemoprevention decision antecedents and quality, referral for specialized counseling, and chemoprevention uptake among women at an increased risk for breast cancer.","['women at an increased risk for breast cancer', 'urban medical center', '300 patients and 50 healthcare providers', 'high-risk women and healthcare providers to increase breast cancer chemoprevention', 'high-risk women']","['web-based decision support tools', 'standard educational materials alone or in combination with the decision support tools']",[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0282515', 'cui_str': 'Chemoprophylaxis'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]",[],300.0,0.124165,"We describe the study design of a randomized controlled trial examining the effect of two web-based decision support tools on chemoprevention decision antecedents and quality, referral for specialized counseling, and chemoprevention uptake among women at an increased risk for breast cancer.","[{'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Crew', 'Affiliation': 'Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Silverman', 'Affiliation': 'Department of Biomedical Informatics, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Vanegas', 'Affiliation': 'Department of Biomedical Informatics, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Meghna S', 'Initials': 'MS', 'LastName': 'Trivedi', 'Affiliation': 'Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Dimond', 'Affiliation': 'Sassafras Tech Collective, Ann Arbor, MI, USA.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Mata', 'Affiliation': 'Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Sin', 'Affiliation': 'Department of Biomedical Informatics, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Tarsha', 'Initials': 'T', 'LastName': 'Jones', 'Affiliation': 'Christine E Lynn College of Nursing, Florida Atlantic University, Boca Raton, FL, USA.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Terry', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Wei-Yann', 'Initials': 'WY', 'LastName': 'Tsai', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Kukafka', 'Affiliation': 'Herbert Irving Comprehensive Cancer Center, Columbia University, New York, NY, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2019.100433']
3094,30821654,Resting-state networks and neurometabolites in children with ADHD after 10 weeks of treatment with micronutrients: results of a randomised placebo-controlled trial.,"Children with attention-deficit/hyperactivity disorder (ADHD) show significant abnormalities on MR imaging in network communication and connectivity. The prefrontal-striatal-cerebella circuitry, involved in attention is particularly disrupted. Neurometabolites, the biochemical structures that support neurological structural integrity, particularly in the prefrontal cortex and striatum are associated with symptoms. This study aimed to explore changes in neurometabolite levels through treatment with vitamins and minerals (micronutrients), hypothesising that treatment would impact neural circuitry and correspond to a reduction in symptoms. Twenty-seven non-medicated children ( M  = 10.75 years) with DSM5 diagnosed ADHD were randomised to receive daily micronutrients or placebo for 10 weeks. Main outcome measures included the Clinical Global Impression-Improvement Scale and ADHD-RS-IV Clinician Ratings of ADHD symptoms. Magnetic resonance spectroscopy of the bilateral pre-frontal cortex and bilateral striatum, resting state fMRI and structural images were acquired 1 week pre-treatment, and in the last week of intervention. Results did not show any significant differences in the measured brain metrics and the levels of neurometabolites between treatment and placebo groups after ten weeks of treatment with micronutrients. In the treatment group there was a trend for: decreased choline in the striatum; decreased glutamate in the prefrontal cortex; increased grey matter in the anterior thalamus; increased white matter in the fornix and improved network integrity of the default mode network, dorsal attention network and frontal executive network. The small sample size of the current study limits results, future studies with higher power are warranted to explore any association between micronutrient treatment and neurological changes.",2020,Results did not show any significant differences in the measured brain metrics and the levels of neurometabolites between treatment and placebo groups after ten weeks of treatment with micronutrients.,"['children with ADHD after 10 weeks of treatment with micronutrients', 'Twenty-seven non-medicated children (M\u2009=\u200910.75 years) with DSM5 diagnosed ADHD', 'Children with attention-deficit/hyperactivity disorder (ADHD']","['vitamins and minerals (micronutrients', 'placebo', 'daily micronutrients or placebo']","['network integrity of the default mode network, dorsal attention network and frontal executive network', 'Clinical Global Impression-Improvement Scale and ADHD-RS-IV Clinician Ratings of ADHD symptoms', 'measured brain metrics and the levels of neurometabolites']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",27.0,0.0816488,Results did not show any significant differences in the measured brain metrics and the levels of neurometabolites between treatment and placebo groups after ten weeks of treatment with micronutrients.,"[{'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Borlase', 'Affiliation': 'New Zealand Brain Research Institute, Christchurch, New Zealand.'}, {'ForeName': 'Tracy R', 'Initials': 'TR', 'LastName': 'Melzer', 'Affiliation': 'New Zealand Brain Research Institute, Christchurch, New Zealand.'}, {'ForeName': 'Matthew J F', 'Initials': 'MJF', 'LastName': 'Eggleston', 'Affiliation': 'Child and Family North Community and Outreach Team, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Darling', 'Affiliation': 'Department of Psychology, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Julia J', 'Initials': 'JJ', 'LastName': 'Rucklidge', 'Affiliation': 'Department of Psychology, University of Canterbury, Christchurch, New Zealand.'}]",Nutritional neuroscience,['10.1080/1028415X.2019.1574329']
3095,31740723,Oxytocin reduces the functional connectivity between brain regions involved in eating behavior in men with overweight and obesity.,"BACKGROUND


Oxytocin (OXT), shown to decrease food intake in animal models and men, is a promising novel treatment for obesity. We have shown that in men with overweight and obesity, intranasal (IN) OXT reduced the functional magnetic resonance imaging (fMRI) blood oxygenation level-dependent signal in the ventral tegmental area (VTA), the origin of the mesolimbic dopaminergic reward system, in response to high-calorie food vs. nonfood images. Here, we employed functional connectivity fMRI analysis, which measures the synchrony in activation between neural systems in a context-dependent manner. We hypothesized that OXT would attenuate the functional connectivity of the VTA with key food motivation brain areas only when participants viewed high-calorie food stimuli.
METHODS


This randomized, double-blind, and placebo-controlled crossover study of 24 IU IN OXT included ten men with overweight or obesity (mean ± SEM BMI: 28.9 ± 0.8 kg/m 2 ). Following drug administration, subjects completed an fMRI food motivation paradigm including images of high and low-calorie foods, nonfood objects, and fixation stimuli. A psychophysiological interaction analysis was performed with the VTA as seed region.
RESULTS


Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05). There was no difference in functional connectivity between VTA and these brain areas when comparing OXT and placebo for low-calorie food, nonfood, and fixation images.
CONCLUSION


In men with overweight and obesity, OXT attenuates the functional connectivity between the VTA and food motivation brain regions in response to high-calorie visual food images. These findings could partially explain the observed anorexigenic effect of OXT, providing insight into the mechanism through which OXT ameliorates food cue-induced reward anticipation in patients with obesity. Additional studies are ongoing to further delineate the anorexigenic effect of OXT in obesity.",2020,"Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05).","['men with overweight and obesity', 'ten men with overweight or obesity (mean\u2009±\u2009SEM BMI: 28.9\u2009±\u20090.8\u2009kg/m 2 ', 'men with overweight and obesity, intranasal (IN', 'patients with obesity']","['OXT', '24 IU IN OXT', 'placebo', 'Oxytocin', 'OXT and placebo', 'Oxytocin (OXT']","['insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods', 'functional connectivity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0228262', 'cui_str': 'Operculum structure'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0453831', 'cui_str': 'High energy food (substance)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.191194,"Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05).","[{'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Kerem', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Nouchine', 'Initials': 'N', 'LastName': 'Hadjikhani', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Holsen', 'Affiliation': ""Division of Women's Health, Department of Medicine and Department of Psychiatry, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Lawson', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. ealawson@partners.org.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Plessow', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. fplessow@mgh.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-019-0489-7']
3096,31884935,Formulation and in vitro Evaluation of Fast Dissolving Tablets of Febuxostat Using Co-Processed Excipients.,"BACKGROUND


Febuxostat is a novel, orally-administered, powerful, non-purine, xanthine oxidase inhibitor used for treating gout and ceaseless tophaceous gout. The drug exhibits low bioavailability (about 49%) which is ascribed to its dissolution rate-limited absorption.
OBJECTIVE


The current work is aimed to provide a novel strategy to improve the dissolution profile and thus, the bioavailability of Febuxostat.
METHODS


Formulation of Fast Dissolving Tablets (FDT) is anticipated to provide immediate release of the drug, which in turn, will improve its dissolution profile to provide the initial surge in plasma concentration required in an acute gout attack. Incorporation of co-processed excipients in a tablet is known to improve the compressibility and disintegration characteristics of the tablets, which, in turn, result in enhanced in vitro drug release and improved bioavailability. A combination of crospovidone (it rapidly wicks saliva into the tablet to create the volume development and hydrostatic weight important to give quick disintegration) and microcrystalline cellulose (a highly compressible ingredient with good wicking and absorbing capacity) was, therefore, used as co-processed excipients.
RESULTS


The tablets were prepared by direct compression technique with the application of a 32 randomized full factorial design. The prepared tablets were able to release more than 80% of the drug within 10 minutes of the start of dissolution testing and were able to show a better drug release profile in comparison to available marketed formulation.
CONCLUSION


So, it can be concluded that the developed fast release formulation was found to exhibit convincing in vitro results and may prove a boon in the treatment of acute gout attack after establishing in vivo potential.",2020,The prepared tablets were able to release more than 80% of the drug within 10 minutes of the start of dissolution testing and were able to show better drug release profile in comparison to available marketed formulation.,[],"['Febuxostat', 'fast dissolving tablets (FDT', 'crospovidone']",['bioavailability'],[],"[{'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0728803', 'cui_str': 'Crospovidone'}]","[{'cui': 'C0005508', 'cui_str': 'Bioavailability'}]",,0.0230538,The prepared tablets were able to release more than 80% of the drug within 10 minutes of the start of dissolution testing and were able to show better drug release profile in comparison to available marketed formulation.,"[{'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Department of Pharmacy, Rayat Bahra Institute of Pharmacy, V. Bohan, Hoshiarpur, Punjab 146004, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Mittal', 'Affiliation': 'Department of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab 144411, India.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gulati', 'Affiliation': 'Department of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab 144411, India.'}, {'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Department of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab 144411, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab 144411, India.'}]",Recent patents on drug delivery & formulation,['10.2174/1872211314666191224121044']
3097,31611105,A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts.,"OBJECTIVE


Paclitaxel-coated balloons are used to reduce neointimal hyperplasia in native arteriovenous (AV) fistulas. However, no study specifically evaluated their effect on venous anastomotic stenosis of dialysis grafts. We aimed to compare the efficacy of angioplasty with drug-coated balloons (DCBs) and angioplasty with conventional balloons (CBs) for venous anastomotic stenosis in dysfunctional AV grafts.
METHODS


In this investigator-initiated, single-center, single-blinded, prospective randomized controlled trial, we randomly assigned 44 patients who had venous anastomotic stenosis to undergo angioplasty with DCBs (n = 22) or CBs (n = 22) from July 2015 to August 2018. Access function was observed per the hemodialysis center's protocols; ancillary angiographic follow-up was performed every 2 months for 1 year after the interventions. The primary end point was target lesion primary patency at 6 months. Secondary outcomes included anatomic and clinical success after angioplasty, circuit primary patency at 6 months and 1 year, and target lesion primary patency at 1 year.
RESULTS


At 6 months, target lesion primary patency in the DCB group was significantly greater than that in the CB group (41% vs 9%; hazard ratio [HR], 0.393; 95% confidence interval [CI], 0.194-0.795; P = .006), as was the primary patency of the entire access circuit (36% vs 9%; HR, 0.436; 95% CI, 0.218-0.870; P = .013). At 1 year, the target lesion primary patency in the DCB group remained greater than that in the CB group (23% vs 9%; HR, 0.477; 95% CI, 0.243-0.933; P = .019) but not the primary patency of the access circuit (14% vs 9%; HR, 0.552; 95% CI, 0.288-1.059; P = .056). No difference in anatomic or clinical success was observed; no major complications were noted.
CONCLUSIONS


Angioplasty with DCBs showed a modest improvement in primary patency of venous anastomotic stenosis and all dialysis AV grafts at 6 months. The short-term benefit was not durable to 1 year, and reinterventions were eventually needed.",2020,"No difference in anatomic or clinical success was observed; no major complications were noted.
","['venous anastomotic stenosis of dialysis arteriovenous grafts', '44 patients who had venous anastomotic stenosis to undergo angioplasty with DCBs (n\xa0= 22) or CBs (n\xa0= 22) from July 2015 to August 2018', 'native arteriovenous (AV) fistulas']","['Paclitaxel-coated balloons', 'drug-coated balloon angioplasty', 'angioplasty with drug-coated balloons (DCBs) and angioplasty with conventional balloons (CBs']","['neointimal hyperplasia', 'primary patency of venous anastomotic stenosis and all dialysis AV grafts', 'primary patency of the entire access circuit', 'target lesion primary patency', 'anatomic or clinical success', 'anatomic and clinical success after angioplasty, circuit primary patency at 6\xa0months and 1\xa0year, and target lesion primary patency at 1\xa0year', 'venous anastomotic stenosis of dialysis grafts', 'Access function']","[{'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0919938', 'cui_str': 'Anastomotic stenosis'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0729665', 'cui_str': 'Arteriovenous graft (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula (morphologic abnormality)'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0002996', 'cui_str': 'Dilation, Transluminal Arterial'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C4049446', 'cui_str': 'Neointimal hyperplasia'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0919938', 'cui_str': 'Anastomotic stenosis'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",44.0,0.109425,"No difference in anatomic or clinical success was observed; no major complications were noted.
","[{'ForeName': 'Min-Tsun', 'Initials': 'MT', 'LastName': 'Liao', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan.'}, {'ForeName': 'Cheng-Pin', 'Initials': 'CP', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan.'}, {'ForeName': 'Ting-Tse', 'Initials': 'TT', 'LastName': 'Lin', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan; College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chien-Boon', 'Initials': 'CB', 'LastName': 'Jong', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan.'}, {'ForeName': 'Tsung-Yan', 'Initials': 'TY', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan.'}, {'ForeName': 'Mu-Yang', 'Initials': 'MY', 'LastName': 'Hsieh', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan; College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Mao-Shin', 'Initials': 'MS', 'LastName': 'Lin', 'Affiliation': 'College of Medicine, National Taiwan University, Taipei, Taiwan; Department of Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chu', 'Initials': 'WC', 'LastName': 'Chie', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital, Taipei, Taiwan; School of Public Health, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Cheng', 'Initials': 'CC', 'LastName': 'Wu', 'Affiliation': 'College of Medicine, National Taiwan University, Taipei, Taiwan; Institute of Biomedical Engineering, National Tsing-Hua University, Hsinchu, Taiwan; Cardiovascular Center, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan; Institute of Cellular and System Medicine, National Health Research Institute, Miaoli, Taiwan. Electronic address: chihchengwumd@gmail.com.'}]",Journal of vascular surgery,['10.1016/j.jvs.2019.07.090']
3098,30869991,The effectiveness of acupressure in the management of depressive symptoms and in improving quality of life in older people living in the community: a randomised sham-controlled trial.,"Objective:  The primary aim of the current trial was to assess the clinical effectiveness of acupressure in the management of depression in elderly people compared to patients receiving sham acupressure or standard care alone. Methods:  Randomized sham-controlled trial of acupressure, sham acupressure and standard care alone in older patients with depression living in the community. Patients with a score>/=8 in the Geriatric Depression Scale were recruited for this study. Intervention/sham treatments were provided four times/week for three months. Assessments related to depressive symptoms (primary outcome), well-being, resilience, spirituality and quality of life domains were carried out at baseline, end of the intervention and three-months after the intervention. Results:  118 patients were randomized to intervention (n = 40), sham (n = 40) or control arm (n = 38), with 84 patients providing final analysis data. Significant reduction in mean score of depressive symptoms was found in the acupressure group (from 10.6 (sd = 0.03) to 7.7 (sd = 0.07), p < 0.001 at end of intervention and 8.7 (sd = 0.8), p = 0.002 at follow-up) and the sham acupressure group (from 10.5 (sd = 0.3) to 8.4 (sd = 0.8), p = 0.005) at end of intervention and 8.4 (sd = 0.8), p = 0.006 at follow-up but not in the control group (from 10.8 to 9.9, p = 0.20). Resilience (p = 0.02) and spirituality (p = 0.02) were also improved in the intervention group at the end of intervention assessment but this change was not sustained at follow-up. Mind-body-spirit well-being and social functioning were improved both at the end of intervention and follow-up in the experimental as well as sham group. The sham group showed additional improvements in daily functioning and environmental quality of life. Conclusions:  Although acupressure improved outcomes, a placebo effect was evident. Acupressure may be an effective approach to manage depression in elderly patients, but more evidence is needed in the future before it can be recommended for practice as well as more clear elucidation of any placebo effects.",2020,Mind-body-spirit well-being and social functioning were improved both at the end of intervention and follow-up in the experimental as well as sham group.,"['elderly patients', 'older patients with depression living in the community', '118 patients', 'elderly people compared to patients receiving', 'older people living in the community', 'Patients with a score>/=8 in the Geriatric Depression Scale']","['acupressure', 'sham acupressure or standard care alone', 'acupressure, sham acupressure and standard care alone', 'Acupressure']","['depressive symptoms (primary outcome), well-being, resilience, spirituality and quality of life domains', 'quality of life', 'daily functioning and environmental quality of life', 'mean score of depressive symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0237104', 'cui_str': 'Spiritualities'}, {'cui': 'C0034380'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",118.0,0.16033,Mind-body-spirit well-being and social functioning were improved both at the end of intervention and follow-up in the experimental as well as sham group.,"[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Molassiotis', 'Affiliation': 'School of Nursing, the Hong Kong Polytechnic University, Hong Kong SAR.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Suen', 'Affiliation': 'School of Nursing, the Hong Kong Polytechnic University, Hong Kong SAR.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lai', 'Affiliation': 'School of Nursing, the Hong Kong Polytechnic University, Hong Kong SAR.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Chan', 'Affiliation': 'School of Nursing, the Hong Kong Polytechnic University, Hong Kong SAR.'}, {'ForeName': 'Karen Hong Yun', 'Initials': 'KHY', 'LastName': 'Wat', 'Affiliation': 'Psychogeriatrics team, Kwai Chung Hospital, Hong Kong SAR.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Psychogeriatrics team, Kwai Chung Hospital, Hong Kong SAR.'}, {'ForeName': 'Kui-Lung', 'Initials': 'KL', 'LastName': 'To', 'Affiliation': 'Psychogeriatrics team, Kwai Chung Hospital, Hong Kong SAR.'}, {'ForeName': 'Cheung-On', 'Initials': 'CO', 'LastName': 'Leung', 'Affiliation': 'Psychogeriatrics team, Kwai Chung Hospital, Hong Kong SAR.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, the Hong Kong Polytechnic University, Hong Kong SAR.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, the Hong Kong Polytechnic University, Hong Kong SAR.'}, {'ForeName': 'Wai Tong', 'Initials': 'WT', 'LastName': 'Chien', 'Affiliation': 'School of Nursing, Chinese University of Hong Kong, Hong Kong SAR.'}]",Aging & mental health,['10.1080/13607863.2019.1584789']
3099,30963820,EMPATHY: A New Tool for Identifying the Most Suitable Thyroxine Formulation in Hypothyroid Patients.,"Background:  Therapy of hypothyroidism is based on the administration of appropriate doses of levothyroxine (LT4). A failure to achieve the thyrotropin (TSH) target may be due to poor compliance with the LT4 therapy in about 60% of cases or to malabsorption in about 40% of cases. No tools are available for detecting malabsorption disorders before the choice of the most appropriate therapy. The aim of this study was to validate the Evaluation of Malabsorption in PATients with HYpothyroidism (EMPATHY) questionnaire and to demonstrate its usefulness in indicating the most appropriate therapy.  Methods:  EMPATHY consists of seven questions that allow the evaluation of several intolerances and allergies. Three hundred (100 males) newly diagnosed hypothyroid patients were enrolled and randomly assigned to complete an EMPATHY questionnaire (150 patients; group 1) or to a control group (150 patients; group 2). The choice of thyroxine formulation and dose for each group was made on the basis of the questionnaire answers or based on the history. Thyroid hormones and TSH were evaluated at enrollment and then every two months for six months; the number of the dose adjustments in the six months for each patient was recorded.  Results:  Of the 150 patients in each group, 21 (14%) in group 1 and 42 (28%) in group 2 ( p  = 0.005) needed more than two dose adjustments within six months. After six months of replacement therapy, six (4%) patients in group 1 and 17 (11%) in group 2 ( p  = 0.03) did not have appropriately controlled hypothyroidism (TSH ≥2.5 mIU/L). A significantly higher LT4 final dose was found in group 2 (148 ± 33 μg/day) than in group 1 (136 ± 28 μg/day;  p  = 0.003).  Conclusions:  Validation of EMPATHY provides endocrinologists with a useful tool in clinical practice, permitting a better personalization of LT4 replacement therapy, a more rapid attainment of the target TSH levels, and a decreased need for dose adjustments after initiating therapy.",2019,A significantly higher LT4 final dose was found in group 2 (148 ± 33 μg/day) than in group 1 (136 ± 28 μg/day;  p  = 0.003).  ,"['Three hundred (100 males) newly diagnosed hypothyroid patients', 'Hypothyroid Patients', 'PATients with HYpothyroidism (EMPATHY) questionnaire']","['EMPATHY', 'thyroxine formulation', 'EMPATHY questionnaire', 'thyrotropin (TSH', 'levothyroxine (LT4']","['Thyroid hormones and TSH', 'LT4 final dose']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2609422', 'cui_str': 'Hypothyroidism (SMQ)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C1881373', 'cui_str': ""L-3,5,3',5'-Tetraiodothyronine""}]","[{'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",,0.0270615,A significantly higher LT4 final dose was found in group 2 (148 ± 33 μg/day) than in group 1 (136 ± 28 μg/day;  p  = 0.003).  ,"[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Bellastella', 'Affiliation': '1Endocrinology and Metabolic Diseases Unit, Department of Advanced Medical and Surgical Sciences, University of Campania ""L. Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Caputo', 'Affiliation': '1Endocrinology and Metabolic Diseases Unit, Department of Advanced Medical and Surgical Sciences, University of Campania ""L. Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Maria Ida', 'Initials': 'MI', 'LastName': 'Maiorino', 'Affiliation': '1Endocrinology and Metabolic Diseases Unit, Department of Advanced Medical and Surgical Sciences, University of Campania ""L. Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Longo', 'Affiliation': '1Endocrinology and Metabolic Diseases Unit, Department of Advanced Medical and Surgical Sciences, University of Campania ""L. Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Scappaticcio', 'Affiliation': '1Endocrinology and Metabolic Diseases Unit, Department of Advanced Medical and Surgical Sciences, University of Campania ""L. Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Giugliano', 'Affiliation': '1Endocrinology and Metabolic Diseases Unit, Department of Advanced Medical and Surgical Sciences, University of Campania ""L. Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Esposito', 'Affiliation': '2Diabetes Unit, Department of Advanced Medical and Surgical Sciences, University of Campania ""L. Vanvitelli,"" Naples, Italy.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2018.0493']
3100,31517759,Effects of a Physical Therapist Led Workplace Personal-Fitness Management Program for Manufacturing Industry Workers: A Randomized Controlled Trial.,"OBJECTIVE


Workplace fitness programs are used to improve worker physical capacity. We aimed to evaluate the effectiveness of physical therapist (PT) led personal-fitness management programs (PP) on manufacturing worker physical performance assessed using a 30-second chair stand (CS-30) test.
METHODS


This assessor-blinded, randomized controlled trial enrolled 60 manufacturing workers allocated to a workplace PP group (PPG) or control group (CG). The PPG received monthly, PT managed, individualized PP for 6 months. The CG received a 90-minute group-fitness management course once during the study period.
RESULTS


CS-30 significantly improved in both groups (PPG and CG, P < 0.001) following the intervention. There were significant group-time interaction effects, and the PPG experienced a significantly greater improvement in CS-30 results compared with CG (P < 0.001).
CONCLUSIONS


Individualized PT-led workplace PP may be more effective in improving worker physical performance.",2019,"CS-30 significantly improved in both groups (PPG and CG, P < 0.001) following the intervention.","['60 manufacturing workers', 'Manufacturing Industry Workers']","['physical therapist (PT) led personal-fitness management programs (PP', 'workplace PP group (PPG) or control group (CG', 'Physical Therapist Led Workplace Personal-Fitness Management Program']","['CS-30 results', 'worker physical performance', 'CS-30', 'time interaction effects']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0021267', 'cui_str': 'Industry'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C2607857'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",60.0,0.0822112,"CS-30 significantly improved in both groups (PPG and CG, P < 0.001) following the intervention.","[{'ForeName': 'Ryutaro', 'Initials': 'R', 'LastName': 'Matsugaki', 'Affiliation': 'Graduate School of Medical Science, University of Occupational and Environmental Health (Mr Matsugaki); Rehabilitation Center, University Hospital of Occupational and Environmental Health (Mr Matsugaki); Renesas Electronics Corporation, Oita Factory, Oita (Ms Sakata); Department of Rehabilitation Medicine (Dr Itoh, Dr Matsushima, Dr Saeki), University of Occupational and Environmental Health, Japan.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Sakata', 'Affiliation': ''}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Itoh', 'Affiliation': ''}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Matsushima', 'Affiliation': ''}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saeki', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001712']
3101,31868799,Protocol on transcranial alternating current stimulation for the treatment of major depressive disorder: a randomized controlled trial.,"BACKGROUND


Transcranial alternating current stimulation (tACS) offers a new approach for adult patients with major depressive disorder (MDD). The study is to evaluate the efficacy and safety of tACS treating MDD.
METHODS


This is an 8-week, double-blind, randomized, placebo-controlled study. Ninety-two drug-naive patients with MDD aged 18 to 65 years will receive 20 daily 40-min, 77.5-Hz, 15-mA sessions of active or sham tACS targeting the forehead and both mastoid areas on weekdays for 4 consecutive weeks (week 4), following a 4-week observation period (week 8). The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8. Secondary outcomes are the rates of response at weeks 4 and 8 and rate of remission at week 4 based on HDRS-17, the proportion of participants having improvement in the clinical global impression-improvement, the change in HDRS-17 score (range, 0-52, with higher scores indicating more depression) over the study, and variations of brain imaging and neurocognition from baseline to week 4. Safety will be assessed by vital signs at weeks 4 and 8, and adverse events will be collected during the entire study.
DISCUSSION


The tACS applied in this trial may have treatment effects on MDD with minimal side effects.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1800016479; http://www.chictr.org.cn/showproj.aspx?proj=22048.",2019,The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8.,"['major depressive disorder', 'Ninety-two drug-naive patients with MDD aged 18 to 65 years', 'adult patients with major depressive disorder (MDD']","['placebo', 'transcranial alternating current stimulation', 'Transcranial alternating current stimulation (tACS', '20 daily 40-min, 77.5-Hz, 15-mA sessions of active or sham tACS']","['clinical global impression-improvement, the change in HDRS-17 score', 'remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score', 'rates of response at weeks 4 and 8 and rate of remission', 'efficacy and safety']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",92.0,0.347202,The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8.,"[{'ForeName': 'Hong-Xing', 'Initials': 'HX', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Puren Hospital, Beijing 100062, China.'}, {'ForeName': 'Wen-Rui', 'Initials': 'WR', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Wen-Feng', 'Initials': 'WF', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Xiao-Tong', 'Initials': 'XT', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Zhi-Chao', 'Initials': 'ZC', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Dong', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Shu-Qin', 'Initials': 'SQ', 'LastName': 'Zhan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Bao-Quan', 'Initials': 'BQ', 'LastName': 'Min', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Chun-Qiu', 'Initials': 'CQ', 'LastName': 'Fan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Ai-Hong', 'Initials': 'AH', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hai-Qing', 'Initials': 'HQ', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Medical Research & Biometrics Centre, National Centre for Cardiovascular Diseases, Beijing 102300, China.'}, {'ForeName': 'Tian-Mei', 'Initials': 'TM', 'LastName': 'Si', 'Affiliation': 'Peking University Sixth Hospital, Beijing 100083, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hai-Xia', 'Initials': 'HX', 'LastName': 'Leng', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Wei-Jun', 'Initials': 'WJ', 'LastName': 'Ding', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Tian-Yi', 'Initials': 'TY', 'LastName': 'Yan', 'Affiliation': 'School of Life Science, Beijing Institute of Technology, Beijing 100081, China.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000000589']
3102,31182338,Sitagliptin improves diastolic cardiac function but not cardiorespiratory fitness in adults with type 2 diabetes.,"BACKGROUND


People with type 2 diabetes mellitus (T2D) have preclinical cardiac and vascular dysfunction associated with low cardiorespiratory fitness (CRF). This is especially concerning because CRF is a powerful predictor of cardiovascular mortality, a primary issue in T2D management. Glucagon-like pepetide-1 (GLP-1) augments cardiovascular function and our previous data in rodents demonstrate that potentiating the GLP-1 signal with a dipeptidyl peptidase-4 (DPP4) inhibitor augments CRF. Lacking are pharmacological treatments which can target T2D-specific physiological barriers to exercise to potentially permit adaptations necessary to improve CRF and thereby health outcomes in people with T2D. We therefore hypothesized that administration of a DPP4-inhibitor (sitagliptin) would improve CRF in adults with T2D.
METHODS AND RESULTS


Thirty-eight participants (64 ± 1 years; mean ± SE) with T2D were randomized in a double-blinded study to receive 100 mg/day sitagliptin, 2 mg/day glimepiride, or placebo for 3 months after baseline measurements. Fasting glucose decreased with both glimepiride and sitagliptin compared with placebo (P = 0.002). CRF did not change in any group (Placebo: Pre: 15.4 ± 0.9 vs. Post: 16.1 ± 1.1 ml/kg/min vs. Glimepiride: 18.5 ± 1.0 vs. 17.7 ± 1.2 ml/kg/min vs. Sitagliptin: 19.1 ± 1.2 vs. 18.3 ± 1.1 ml/kg/min; P = 0.3). Sitagliptin improved measures of cardiac diastolic function, however, measures of vascular function did not change with any treatment.
CONCLUSIONS


Three months of sitagliptin improved diastolic cardiac function, however, CRF did not change. These data suggest that targeting the physiological contributors to CRF with sitagliptin alone is not an adequate strategy to improve CRF in people with T2D.
CLINICAL TRIALS REGISTRATION


www.clinicaltrials.gov NCT01951339.",2019,"Sitagliptin improved measures of cardiac diastolic function, however, measures of vascular function did not change with any treatment.
","['Thirty-eight participants (64\u202f±\u202f1\u202fyears; mean\u202f±\u202fSE) with T2D', 'adults with type 2 diabetes', 'People with type 2 diabetes mellitus (T2D', 'people with T2D']","['Glimepiride', 'placebo', 'glimepiride', 'Sitagliptin', 'DPP4-inhibitor (sitagliptin', 'Glucagon-like pepetide-1', '100\u202fmg/day sitagliptin, 2\u202fmg/day glimepiride, or placebo']","['diastolic cardiac function', 'CRF', 'cardiac diastolic function', 'vascular function', 'Fasting glucose']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",,0.204482,"Sitagliptin improved measures of cardiac diastolic function, however, measures of vascular function did not change with any treatment.
","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Scalzo', 'Affiliation': ""Division of Endocrinology, Department of Medicine, University of Colorado School of Medicine, United States of America; Center for Women's Health Research, Department of Medicine, University of Colorado School of Medicine, United States of America; Rocky Mountain Regional Veterans Administration Medical Center, United States of America. Electronic address: rebecca.scalzo@ucdenver.edu.""}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Rafferty', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, United States of America.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Schauer', 'Affiliation': ""Division of Endocrinology, Department of Medicine, University of Colorado School of Medicine, United States of America; Center for Women's Health Research, Department of Medicine, University of Colorado School of Medicine, United States of America; Rocky Mountain Regional Veterans Administration Medical Center, United States of America.""}, {'ForeName': 'Amy G', 'Initials': 'AG', 'LastName': 'Huebschmann', 'Affiliation': ""Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, United States of America; Center for Women's Health Research, Department of Medicine, University of Colorado School of Medicine, United States of America.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Cree-Green', 'Affiliation': ""Center for Women's Health Research, Department of Medicine, University of Colorado School of Medicine, United States of America; Division of Pediatric Endocrinology, University of Colorado School of Medicine, United States of America.""}, {'ForeName': 'Jane E B', 'Initials': 'JEB', 'LastName': 'Reusch', 'Affiliation': ""Division of Endocrinology, Department of Medicine, University of Colorado School of Medicine, United States of America; Center for Women's Health Research, Department of Medicine, University of Colorado School of Medicine, United States of America; Rocky Mountain Regional Veterans Administration Medical Center, United States of America.""}, {'ForeName': 'Judith G', 'Initials': 'JG', 'LastName': 'Regensteiner', 'Affiliation': ""Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, United States of America; Center for Women's Health Research, Department of Medicine, University of Colorado School of Medicine, United States of America.""}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.05.002']
3103,31328876,Angiotensin II receptor blocker attenuates stress pressor response in young adult African Americans.,"African Americans (AAs) are susceptible to hypertension (HTN) and its associated organ damage leading to adverse cardiovascular (CV) outcomes. Psychological stress is proposed to contribute to the development of HTN; however, the potential role of the renin-angiotensin system (RAS) in stress-related HTN in AAs is largely unknown. In this study, we tested the hypothesis that activation of RAS is a potential contributing factor for altered CV responses to stress, and suppression of angiotensin II (Ang II) activity will improve hemodynamic responses to a prolonged mental stressor in healthy young AAs. Utilizing a double-blind, randomized, crossover study design, 132 normotensive AAs (25 ± 7 years) were treated with either a placebo (PLC) or 150 mg/d irbesartan (an Ang II type 1 receptor blocker; ARB) for 1 week. On the final day of each treatment, hemodynamic measures and urinary sodium excretion (UNaV) were collected before, during and after a 45 minute-mental stress. The magnitude of stress-induced increase in blood pressure with ARB was blunted and delayed compared to PLC. Systolic blood pressure at the end of recovery on ARB was significantly lower compared to either PLC (110 ± 13 vs 117 ± 12 mm Hg respectively; P < 0.001) or the prestress level on ARB (P = 0.02). ARB treatment reduced overall vasoconstriction and improved poststress UNaV. ARB attenuated blood pressure responses to mental stress and improved the poststress BP recovery process which were partly linked to reduced overall vasoconstriction and improved stress-induced UNaV in young adult AAs prior to the development of disease conditions. These results suggest that treatment approaches that inhibit RAS action could have significant relevance to potentially lower susceptibility to stress responses and eventually the premature development of HTN in AAs.",2019,ARB treatment reduced overall vasoconstriction and improved poststress UNaV. ARB attenuated blood pressure responses to mental stress and improved the poststress BP recovery process which were partly linked to reduced overall vasoconstriction and improved stress-induced UNaV in young adult AAs prior to the development of disease conditions.,"['African Americans (AAs', 'young adult African Americans', 'healthy young AAs', '132 normotensive AAs (25\xa0±\xa07\xa0years']","['PLC', 'Angiotensin II receptor blocker', 'placebo (PLC) or 150\xa0mg/d irbesartan (an Ang II type 1 receptor blocker; ARB', 'ARB']","['Systolic blood pressure', 'hemodynamic measures and urinary sodium excretion (UNaV', 'overall vasoconstriction', 'stress pressor response', 'blood pressure with ARB', 'overall vasoconstriction and improved stress-induced UNaV', 'ARB']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0521942', 'cui_str': 'Angiotensin II Receptor Blockers'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0288171', 'cui_str': 'irbesartan'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1456863', 'cui_str': 'Vasoconstriction'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]",132.0,0.0239157,ARB treatment reduced overall vasoconstriction and improved poststress UNaV. ARB attenuated blood pressure responses to mental stress and improved the poststress BP recovery process which were partly linked to reduced overall vasoconstriction and improved stress-induced UNaV in young adult AAs prior to the development of disease conditions.,"[{'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Jeong', 'Affiliation': 'Department of Population Health Sciences, Georgia Prevention Institute, Augusta University, Augusta, Georgia.'}, {'ForeName': 'Coral', 'Initials': 'C', 'LastName': 'Hanevold', 'Affiliation': 'Department of Pediatrics, Division of Nephrology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Harris', 'Affiliation': 'Department of Population Health Sciences, Georgia Prevention Institute, Augusta University, Augusta, Georgia.'}, {'ForeName': 'Gaston', 'Initials': 'G', 'LastName': 'Kapuku', 'Affiliation': 'Department of Population Health Sciences, Georgia Prevention Institute, Augusta University, Augusta, Georgia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pollock', 'Affiliation': 'Department of Medicine, University of Alabama, Birmingham, Alabama.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pollock', 'Affiliation': 'Department of Medicine, University of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Harshfield', 'Affiliation': 'Department of Population Health Sciences, Georgia Prevention Institute, Augusta University, Augusta, Georgia.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13625']
3104,31901794,Family network satisfaction moderates treatment effects among homeless youth experiencing suicidal ideation.,"OBJECTIVE


Limited research has evaluated the efficacy of suicide prevention interventions among homeless youth, especially considering how their connectedness with their family would impact treatment outcomes.
METHOD


Suicidal homeless youth (N = 150) between the ages of 18-24 years were recruited from a local drop-in center. Youth were randomly assigned to Cognitive Therapy for Suicide Prevention (CTSP) + Treatment as Usual (TAU) or Treatment as Usual alone. Youth reported their family network satisfaction at the baseline assessment, whereas their suicidal ideation, perceived burdensomeness and thwarted belongingness were assessed at baseline and three additional times during a nine-month period.
RESULTS


A multiple-group autoregressive cross-lagged model suggests that CTSP was associated with lower suicidal ideation and lower thwarted belongingness only among those with high family network satisfaction. Among both groups, perceived burdensomeness predicted higher suicidal ideation, which in turn predicted lower perceived burdensomeness and thwarted belongingness. Additionally, only among youth with low family network satisfaction, thwarted belongingness predicted lower suicidal ideation.
CONCLUSIONS


Findings suggest that family network satisfaction may be an important factor when considering cognitive interventions with homeless youth, with implications to improve treatment efforts and to reduce premature mortality, hospitalization and loss of human capital in a very high-risk population.",2020,"Among both groups, perceived burdensomeness predicted higher suicidal ideation, which in turn predicted lower perceived burdensomeness and thwarted belongingness.","['homeless youth experiencing suicidal ideation', 'homeless youth', 'Suicidal homeless youth (N\xa0=\xa0150) between the ages of 18-24 years were recruited from a local drop-in center']","['Cognitive Therapy for Suicide Prevention (CTSP)\xa0+\xa0Treatment as Usual (TAU) or Treatment as Usual alone', 'CTSP']","['suicidal ideation, perceived burdensomeness and thwarted belongingness', 'family network satisfaction', 'suicidal ideation']","[{'cui': 'C0242663', 'cui_str': 'Homeless Children'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0390458,"Among both groups, perceived burdensomeness predicted higher suicidal ideation, which in turn predicted lower perceived burdensomeness and thwarted belongingness.","[{'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Family and Child Sciences, College of Human Sciences, Florida State University, 322 Sandels Building, 120 Convocation Way, Tallahassee, FL, 32306, USA. Electronic address: qwu3@fsu.edu.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Human Development and Family Studies, School of Lifespan Development and Educational Sciences, Kent State University, 406G White Hall, 150 Terrace Drive, P.O. Box 5190, Kent, OH, 44242, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Walsh', 'Affiliation': 'Department of Human Sciences, College of Education and Human Ecology, The Ohio State University, Campbell Hall Room 135, 1787 Neil Ave., Columbus, OH, 43210, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Slesnick', 'Affiliation': 'Department of Human Sciences, College of Education and Human Ecology, The Ohio State University, Campbell Hall Room 135, 1787 Neil Ave., Columbus, OH, 43210, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.103548']